Updating Pesticide Registries and the Precautionary PrincipleActualización de expedientes de plaguicidas y principio precautorio

Res. No. 2023-002389 CONSTITUTIONAL CHAMBER OF THE SUPREME COURT OF JUSTICE. San José, at thirteen hours and forty-five minutes on the first of February two thousand twenty-three.

Action of unconstitutionality filed by [Name 001], bearer of identity card No. [Value 001], in his capacity as president of the board of directors of the COSTA RICAN ASSOCIATION FOR THE ORGANIC AGRICULTURE MOVEMENT, against Executive Decree No. 41481-MAG called "Reform to the Regulation for the updating of information in the registration dossiers of technical grade active ingredient and formulated pesticides".

WHEREAS:

1.- Through a document received at the Constitutional Chamber at 4:14 p.m. on April 4, 2019, Mr. [Name 001], bearer of identity card No. [Value 001], in his capacity as president of the board of directors of the "Costa Rican Association for the Organic Agriculture Movement," filed an action of unconstitutionality against Executive Decree No. 41481-MAG, published on January 11, 2019, by means of Scope No. 8 of the official gazette La Gaceta, considering it contrary to Articles 21 and 50 of the Political Constitution and the precautionary principle.

Regarding his standing, the petitioner asserts that he comes before this Constitutional Chamber based on the fundamental right to a healthy and ecologically balanced environment contained in Article 50 of the Political Constitution and in other norms.

As background, he indicates that in November 2018 the Costa Rican Federation for the Conservation of Nature filed an action of unconstitutionality against Executive Decree No. 39995-MAG, which is being processed under case file No. 18-019039-0007-CO. He alleges that on January 11, 2019, the challenged decree was published, which, according to the petitioner, lacks technical and scientific criteria and further deepens the chemical, environmental, and human and animal health risk, contravening what is indicated in constitutional Articles 21 and 50. It is questioned that this decree is not a partial reform but rather a covert total reform of the aforementioned Decree No. 39995.

On the merits, the petitioner asserts the following: the Phytosanitary Protection Law, Law No. 7664, declares phytosanitary protection measures established in said legal norm to be of public interest and mandatory, its purpose being the protection of plant products, in order to avoid pests and prevent impacts on food security and economic activity based on agricultural production. Said law assigned the control and surveillance of plant food health to the State Phytosanitary Service (SFE). He indicates that such tasks are complemented with other jurisdictional assignments related to the Ministry of Environment and Energy (MINAE), derived from the Law on Use, Management and Conservation of Soils, Law No. 7779. The registration of pesticides, assigned to the SFE, is not exhausted by an analysis of requirement verification, but rather a scientific analysis related to risk assessment must be carried out. Thus, it is that the Ministry of Agriculture (MAG), the Ministry of Health, and MINAE must jointly intervene in the process of registration, post-registration, and revalidation or updating of pesticide information; considering that such products have direct and/or indirect impacts on the environment in general, as they can also have effects on biodiversity (flora and fauna) and consequently, on people's health. Even more so when, in this case, regarding the process of updating or revalidation, we are talking about something that is not a simple update, but rather a scientific analysis of the information presented by the registrant to carry out the respective risk assessment, because for these products, their external effects on the environment and health are unknown. The function entrusted to the SFE to "register" pesticides should not be understood as a merely mechanical action by the Administration, in which a simple verification of a checklist of requirements established in the applicable regulations, whether legal or regulatory, is performed. On the contrary, and as indicated by the Comptroller General of the Republic (CGR) in its report No. FOE-AM-19/2004: it is an essential function in the protection of the environment and health, which must be exercised in accordance with national and international regulations.

Detailed analysis of the grievances Regarding Article 1 The partial reform and addition to Executive Decree No. 39995 is a benefit to pesticide marketers, as they extend the time from the publication of the challenged decree, granting the benefit of five additional years to those products without them having undergone a risk assessment and granting that additional time so that the registered owners can submit the information. Six years have elapsed, which was the time limit defined in Law No. 8702 to submit the information and for the ministries involved in the registration process to evaluate said information. Now, with this enacted decree, private enterprise in alliance with the ministerial office is extending the time so that said products can be marketed in the country without chronic toxicological, ecotoxicological, and environmental fate information having been evaluated. With this action, it seems that the pesticide marketing companies do not have their own information from the studies that must be submitted, which must adhere to the principles of science and technique as established by national and international regulations. The only thing sought is to extend the time to continue selling chemical products without a comprehensive evaluation, which shows that the 2011 discourse was only a position of mere formalities as long as they are allowed to continue contaminating the environment and playing with the health of Costa Ricans with products that lack their own information or chemical equivalence for carrying out a chemical, toxicological, and ecotoxicological evaluation to perform the risk assessment, and in this way, a decision can be made on whether or not the product can continue to be marketed in Costa Rica, or, if applicable, under what circumstances it can continue to be marketed or sold without any restriction. Even though a closed list of requirements is defined in this same section, these are limited for performing a risk assessment. Furthermore, the decree must be applied and interpreted by the registration analysts of the different ministries in a comprehensive manner with the provisions of the legal system on the matter, that is, it cannot in any way be understood that it constitutes an isolated normative body from the rest of the block of legality. What the ministerial office pursues with the enactment of this type of documents is to require, order, or intimidate registration evaluators to limit themselves solely to requesting limited information, lacking technical and scientific support to carry out a risk assessment according to national and international norms, with decimated requirements that depart from what has already been indicated by the CGR in its reports 19-2004 and 238-2006, thus hindering the carrying out of a scientific evaluation consistent with the General Law of Public Administration (LGAP) in compliance with constitutional Articles 21 and 50. The evaluating officials of the registration information, in fulfillment of that constitutional responsibility, are obliged to request, through technical reasoning, the information they need to ensure that the pesticide does not have negative externalities on health and the environment. In the article in question, the MAG again insists on the process of referenced information as tacitly indicated in Decree No. 39995-MAG, which is practically repealed with the publication of this new decree, which indicates the following:

"In case there is an international specification for the technical grade active ingredient subject to updating, it must be provided by the applicant in order to prove that the technical material being subjected to the updating process does not contain relevant impurities at levels higher than the recognized international standards, the only international information that can be provided is referenced information from another product".

Without its own or referenced information as proposed by this regulation, what the Executive Branch and the pesticide industry seek is to facilitate the trade of pesticides against human, animal, and environmental health. So, it is proposed to evaluate a pesticide whose information and chemical and physical characteristics are from another product that is available as general information on the internet, which has no relationship with the product to be revalidated or registered. If they refer to the same active ingredient, the minimum that can be done in accordance with national and international norms is the chemical equivalence study.

Regarding Article 2 The proposed reform reduces the time for evaluators to make a decision, going from three months defined in Executive Decree No. 39995 to one month in the modification proposed in Decree No. 41481-MAG. It is evident in this type of regulation that what is sought is the benefit of agrochemical selling companies, so that registration analysts carry out the analysis pressured by time, without evidence of a workload study to determine the proposed time. But more seriously, said analysis proposed in this decree is defined as a simple verification of chemical documents, that is, whether the registrants submitted the information or not. However, such is the degree of lack of coordination that this verification of documents, which are of a chemical nature, is assigned to agronomy professionals, who do not have the competencies or training to perform this task. This proposal is a new registration modality carried out only with a simple "check list" or verification list.

Regarding Article 3 Again, the ministerial office shortens the time established in Executive Decree No. 39995 for the benefit of users, without it being known whether there is a technical workload study supporting such a decision to go from three months to ten days for the technical evaluation to be carried out by SFE officials, since in this decree they unilaterally exclude the participation of the corresponding ministries on health and environmental issues. The prioritization of the ministerial office is once again evident, which is the favoring of the agrochemical selling industry of having their registrations in the shortest possible time and without the technical risk assessment, which breaches the State's duties regarding agrochemical registration established in accordance with constitutional Articles 21 and 50.

The paragraph questioned by the petitioner notes that "for formulated pesticides that do not have a registration of technical grade active ingredient associated with that formulation and whose manufacturer of that formulated product has been updated in accordance with this regulation, the SFE will grant them the registration certificate for technical grade active ingredient." The decree opposes any active scientific technical principle governing the registration matter, as it is granting a registration without even mediating the basic process governing the registration regulations, which is chemical evidence.

Regarding Article 4 (which reforms Article 5 of Decree No. 39995) The registration facilitation process established by Executive Decree No. 414131 goes against the State's duty to protect all Costa Rican society. They merely list requirements to get by, which will not support any information for carrying out a technical-scientific analysis of risk assessment. This particular issue, because this entire regulatory proposal is a setback to the regulations established in the country, is returning to a period prior to or equal to the year 2004, disregarding the opinions of the CGR.

Regarding Article 5 (which reforms Article 6 of Decree No. 39995) The chemical equivalence process proposed in this article contradicts international norms, Constitutional Chamber ruling No. 2011-016937, and the CGR reports. A procedure for the evaluation of equivalence in formulated products has not been proposed by these institutions, and it alludes to the Manual on Pesticide Specifications and CropLife Equivalence 2014.

The proposal for the SFE to create and publish a database with toxicological, ecotoxicological, and environmental fate information can be limited to what has already been indicated by SANCO, since sensitive information that can be classified as copyright is confidential and hence it is not a solution as set forth in this decree to have all the information of a product.

Regarding Article 6 (which reforms Article 7 of Decree No. 39995) With an unscientific registration proposal that departs from national and international norms, which could be unconstitutional, the Executive Branch enacted this decree which, in congruence with its objective, should have been titled "regulation for registration facilitation," since the priority is the updating or revalidation of registration with referenced information, pressuring registration analysts by shortening response times, proposing the registration process with only a simple verification of information, and separating the ministries of health and environment in their registration analysis.

Regarding Article 9 (which reforms and adds a new Article 11 to Decree No. 39995) Continuing with the registration facilitation process and without any analysis responding to technical and scientific support according to national and international norms, the Executive Branch proposes homologating the uses of a product with another having similarity in the active ingredient, concentration, and formulation, when in this particular case the minimum that can be done is the chemical equivalence of the active ingredient. But since it refers to a formulated product, the co-formulants must be analyzed, which must be declared, so that the risk analysis can be performed by the ministries of health and environment, and a biological efficacy study must be submitted, respecting the unequivocal rules of science and technique. It must be taken into consideration that a formulated product is composed of a percentage of the active ingredient and the rest known as co-formulants, and wrongly called inerts. Many times the secret of the formulated product is not in the composition of the active ingredient but in the co-formulants, some of which are much more toxic to health and the environment than the active ingredient itself. This type of decree only seeks to give agrochemical selling companies more time to continue with the process of marketing and the use of substances that are dangerous and can cause serious harm to the health of the Costa Rican population, affect biodiversity, and damage the environment, because the registrations have not been comprehensively evaluated. In other words, they do not have the chronic toxicology study, and an ecotoxicological assessment has not been performed on any of these registrations, and many might not be functioning at the doses at which they were registered. This type of decree could be considered a violation of human rights, because the responsible authorities have not acted with due diligence and continue postponing, with this type of decrees, the evaluation of the technical information specific to each registration. Furthermore, the decree lacks technical justification on the matter of pesticides and seeks to make requirements more flexible, to the detriment of the life and health of people, especially agricultural laborers and farmers.

He requests that the action of unconstitutionality be granted.

2.- By resolution at 3:40 p.m. on April 8, 2019, the Presidency of the Constitutional Chamber admitted the present action of unconstitutionality. Furthermore, the publication of the corresponding edicts in the Judicial Bulletin was ordered. A hearing was granted to the Attorney General of the Republic and the Minister of Agriculture and Livestock.

3.- Through a document received at this Constitutional Chamber on May 9, 2019, Luis Renato Alvarado Rivera, in his capacity as Minister of Agriculture and Livestock, responded to the hearing. In the first place, he indicates that the arguments put forth by the petitioner concern the contentious-administrative jurisdiction and not the constitutional one, as the dispute concerns questions of legality. To this end, he proceeds to make a historical account of several legal norms related to phytosanitary matters. He says that if the petitioner believes that the norm should have been enacted jointly with other bodies, such an argument should be discussed in that jurisdiction and not in the Constitutional Chamber. He considers that the executive decree in question acts in prevention of environmental and human and animal health risk. He adds that one of the objectives of the Phytosanitary Protection Law is to regulate the use and management of chemical, biological, or related substances and equipment, for their application in agriculture; likewise, their registration, importation, quality, and residues, while seeking at the same time to protect human health and the environment, therefore the legal and technical norms related to phytosanitary protection must be interpreted in accordance with the constitutional duty of the State and society in general to act in prevention of environmental and health risk, both human and animal, as is indeed done when issuing Executive Decree No. 39995-MAG and No. 41481-MAG.

He affirms that the legislator conferred on the SFE the competence for achieving the purposes contained in the Phytosanitary Protection Law and that this jurisdictional assignment is exclusive to said body, within which falls the carrying out and custody of the respective registrations. He cites, in support of his argumentation, Opinions C-171-2000, C-255-2009, and C-215-2013 of the Office of the Attorney General (PGR).

He emphasizes that the decree for updating dossiers and its reform applies exclusively to all registrations of "technical grade active ingredient" (IAGT) and formulated products that were registered under a regulation (legal or regulatory) different from Executive Decree No. 33495-MAG-S-MEIC-MINAET, "Regulation on the Registration, Use and Control of Synthetic Formulated Pesticides, Technical Grade Active Ingredient, Adjuvants and Related Substances for Agricultural Use." That is, he underlines that it only applies to those product registration dossiers that are already on the market and that were registered in accordance with the regulations applicable at the time of their approval and were evaluated comprehensively (health, environment, and biological efficacy) according to that regulation; therefore, if the petitioner believes that said regulation has legality defects, he must discuss them in the corresponding jurisdictional venue and not in the constitutional venue. He considers it unacceptable and improper for the petitioner to attempt, in the constitutional venue, to discuss legal aspects that are not within the purview of the constitutional venue but of the ordinary courts.

He argues that the petitioner confuses and intends to confuse regarding the agrochemicals registered and currently marketed in the country, which are the ones to which Executive Decree No. 39995-MAG and No. 41481-MAG apply, intending to make it seem that they must be newly evaluated, which is neither appropriate nor necessary, because all products registered in Costa Rica complied with the requirements and regulations established in the positive law in force at the time those registrations were granted. Consequently, he clarifies, vehemently and repeatedly, that for none of the pesticide products, whether raw materials or formulated products that have a valid registration, is there evidence or technical-scientific presumption, or at least indications, that presume an additional or resulting danger from its application, regarding human health, the environment, or the biological efficacy of the pesticide. Both the Constitutional Chamber and the PGR have been clear in the sense that the Ministry of Health, the Ministry of Environment, the Ministry of Agriculture, and even private parties can go to the ordinary jurisdictional venue to request the annulment of the administrative acts by which those registrations were granted and can even request, as a precautionary measure, that their marketing be suspended. However, neither the Ministry of Health, nor the Ministry of Environment, nor the petitioner do so because they lack evidence, scientific and technical support, and, for that reason, they recklessly come to the Constitutional Chamber to raise issues of legality through actions of unconstitutionality, with the sole aim and objective of hindering the process of organizing the agrochemical registration system undertaken by the Administration.

He insists that the decrees mentioned—No. 39995-MAG and No. 41481-MAG—are not granting registrations for IAGT or for new formulated pesticides, but rather only apply to old IAGT (raw materials) and formulated products.

He explains that it was from 2007 onwards that a registration system was established that requires prior registration of the raw material—IAGT—. Before that date, it was not necessary to register the IAGT, and that is why the Executive Branch issued the decrees under challenge. He adds that it is not as the petitioner indicates that the challenged norms are facilitating the registration of new products, because the truth is that nothing is being facilitated, but rather a space is opened for the owners of the registrations to submit the confidential chemical information that is fundamental to guarantee that there are no relevant impurities from a toxicological and ecotoxicological point of view in any of the products currently marketed on the market under a valid registration, granted for an indefinite term. Therefore, it is not correct to state that by applying these norms, the registrations updated in their dossiers pose an additional risk to health, the environment, or agriculture, because all IAGT registrations granted must necessarily and inevitably correspond to one of the formulations already sold on the market, and, regarding these formulations, the Ministries of Health or Environment have broad and indisputable competencies and powers to adopt the pertinent measures to prevent harm to health or the environment, not only by going to the jurisdictional route to annul the administrative acts under which the registration was granted, but also by preventing, through precautionary or interim measures, any act that implies or entails the importation, manufacture, handling, storage, transport, marketing, supply, and the use and application of the product considered to damage health or the environment, as the PGR and the Constitutional Chamber itself have determined on repeated occasions.

He echoes that every granted registration can be revoked or annulled, obviously through the lesivity process, if it is demonstrated that it poses an unacceptable risk to health or the environment, and within that process, precautionary measures can be requested that imply the suspension of the importation, marketing, and use of that pesticide, until its registration is annulled; in such a way that the radical environmentalists who unsuccessfully filed the amparo action and the action of unconstitutionality against Executive Decree No. 39995-MAG of December 15, 2016, cannot pretend that the Chamber annul the registrations without demonstrating and proving the scientific evidence that demonstrates the effect or risk to health or the environment.

He reiterates that the decrees are only applicable to old IAGT and formulated products, that is, those for which registrations were already granted in the country and which have been used for many years, a use that has allowed knowing with certainty their behavior, safety, and efficacy; all are products that already have a registration and can therefore be marketed because they have a valid registration, in accordance with the regulations that were in force at the time they were granted. The registrations were recorded because they complied with the requirements, procedures, and evaluations established by that regulations in force, therefore, those products are covered by a registration and that legal situation cannot be ignored by the active administration.

Regarding the application of the precautionary principle in pesticide matters, he invokes PGR Opinion No. C-255-2009 and states that the competencies of the Ministry of Health and the Ministry of Environment and Energy remain, particularly regarding the life and health of people, and he insists on the legality issues already explained. He reiterates that once a specific product is registered, the Public Administration creates a consolidated legal situation and that in any case, precautionary or annulment measures can be ordered if any effect on life or health is verified.

He points out that Executive Decree No. 39995-MAG and its reform No. 41481-MAG allow resolving the problems of disorder, uncertainty, and lack of information in the dossiers that support the registrations of IAGT and formulated pesticides with valid registration, but which were granted under a regulation different from Executive Decree No. 33495-MAG-S-MINAE-MEIC. He considers that the questioned regulation is a great advance and resolves a problem that began in 2004 and had not yet been resolved by previous administrations, as it provides for the alternatives and ways to resolve the two most serious problems afflicting our country's registration system: on the one hand, the paralysis in the registration of new and generic products, and, on the other, the impossibility of renewing the registrations of formulations currently on the market.

He states that one of the virtues of the executive decree in question is that it allows the application of the new regulation for the registration of phytosanitary products, as it made the validity of registrations uniform and associated the formulations with the manufacturers, in relation to previous executive decrees. In that sense, he details that the challenged regulation allows: a) the updating of the manufacturers, their origin, production sites of the IAGT associated with the formulations already marketed in Costa Rica and that were registered with different legislation; b) the same in relation to formulated pesticides; c) to end the legal uncertainty regarding the validity of IAGT registrations and formulated pesticides that were registered with previous legislation and regulations, making the validity period of ten years uniform for all registrations and thereby ending the indefinite validity; to equate the registrations of old formulations to the current registration system by granting them the registration of IAGT, thereby eliminating formulations that do not have a duly updated associated one, and to order and update the labels and leaflets with which formulated pesticides are being marketed in Costa Rica, in such a way that from the regulation onwards, any change or modification of label and leaflet is recorded in the physical dossier of the product.

He explains that the regulation in question comes to comply with some provisions adopted since 2004 that have not been complied with, specifically: 1) that all registrations must have a reasonable validity period, and with the decree, all registrations that had been granted for an indefinite term now have a validity of ten years, that is, registrations of indefinite validity are ended; 2) that all chemical information on the purity, total impurities, or relevant impurities, as well as the synthesis route of the technical material with which the pesticide is formulated, must be recorded in the registration dossier.

He reproaches that the petitioner intends to hinder the process of updating dossiers and does not provide documentary or scientific evidence, and considers that an enumeration of the constitutional rights and guarantees violated is lacking. He insists that in case files 17-005922-0007-CO and 17-002503-0007-CO, an action of unconstitutionality and an amparo action were filed—respectively—against the executive decree subject to this process and that both were rejected, and he especially highlights the reasoning of the separate note of Magistrate Hernández López in this regard.

It challenges the plaintiff's argument regarding the updating process as a reevaluation process, stating that any of the products that currently have a valid registration can be suspended or annulled if they represent any risk to health or the environment. Furthermore, it alleges that the plaintiff omits to mention that these are products whose technical-grade active ingredient (IAGT) and the formulated product associated with it are already on the market and are not new products that require an evaluation prior to granting a registration that allows their commercialization, such that the plaintiff is incorrect in making such assertions, and it questions where the plaintiff gets the idea that the updating process is a risk reevaluation process for a product already marketed and holding a valid registration.

It argues that the reports of the CGR invoked by the plaintiff have been taken out of context, and that they are being applied to a different legal situation. It indicates that in the case of report DFOE-AM-19-2004, the previous decree regulating the matter was in force—specifically, 24337-MAG-S of 1995—so the assessments made by the CGR at that time are not applicable:

"Finally, in the background, the plaintiff cites a report from the Office of the Comptroller General, taking it out of context and attempting to apply it to an absolutely different legal situation, and it seems to us that, although it is true this is not an issue of constitutionality, we will make some clarifications regarding said report and its contextualization. Report DFOE-AM-19-2004 of October 20, 2004, analyzes what was happening with the functioning of the registry and its different processes at that time, as well as the regulations in force at that moment, in this case the Reglamento para Registro, Uso y Control de Plaguicidas Agrícolas y Coadyuvantes, promulgated by Decreto Ejecutivo number: 24337-MAG-S of 04/27/95, not in force since 2007. It remained in application for almost twelve years and even survived the repeal of the Law that gave it origin, this because its legal basis was the Ley de Sanidad Vegetal 6248 of 05/02/78 and not the Ley de Protección Fitosanitaria. Precisely, Decreto Ejecutivo number: 24337-MAG-S of 04/27/95, which was the one in force at the time the Office of the Comptroller General audited the registration processes, did not establish a separation of information files and did not even include in its list of requirements the presentation of confidential chemical information, nor did it incorporate the determination of IAGT equivalence as a registration modality. Hence, during the validity of said regulation, there was no discussion of registration for equivalence, reference profiles, confidential information, or test data protection. Regarding the prior assessment of the impact of pesticides on health and the environment, report DFOE-AM-19-2004 of October 20, 2004, is clear in the sense that it was not being done efficiently, which was logical since the SFE did not have within its structure the competent units to evaluate the toxicological and ecotoxicological information provided by registrants, and therefore it determined that said evaluation should be carried out by the Ministry of Health and the Ministry of Environment, respectively. The Office of the Comptroller General also recommended, in the report in question, that a new regulation be issued based on the Ley de Protección Fitosanitaria, since the law supporting the regulation in force at that time had already been repealed.

An aspect to highlight is that when report DFOE-AM-19-2004 of October 20, 2004, was issued, the FAO had not yet prepared (it did so in 2006) the document that had foreseen the registration of IAGT when there was no reference profile with referenced information. Indeed, the FAO document: AGENDA ITEM NUMBER 12.3A. INTERNATIONAL CODE OF ON THE DISTRIBUTION AND USE OF PESTICIDAS: DRAFT GUIDELINES ON DATA REQUIREMENTS FOR THE REGISTRATION OF PESTICIDAS, which is from October two thousand six, states the following: 'If there are no technical products registered in the country with complete data, the technical-grade active ingredients intended for registration cannot do so through equivalence, but rather through the normal procedure (…) For products for which a complete risk assessment has not been carried out in a given country, due to the lack of data and/or failures by the original registrant(s) to provide the complete data set required for a risk assessment, any active ingredient previously registered by the original registrant(s) or subsequent registrants, may be used by a country's registration authorities as a source of reference for the equivalence assessment, provided that all the chemical information required for registration is available, regardless of whether the risk assessment is not complete." (The underlining does not correspond to the original).

It mentions, moreover, that said report was issued prior to the promulgation of Law No. 8622, which incorporated the Dominican Republic-Central America-United States Free Trade Agreement (CAFTA, by its acronym in English) into the Costa Rican legal system. In this same vein, it establishes that when said report was issued, the Food and Agriculture Organization of the United Nations (FAO, by its acronym in English) had not yet promulgated the Manual on the Development and Use of FAO and WHO Specifications for Pesticides, nor the principle of non-repetition of studies, a principle incorporated in Considerando XIII of Decreto Ejecutivo No. 40059-MAG-MINAE-S:

"In said principle, the FAO and WHO recognize that the repetitive generation of studies and information regarding all potential/real risks for each manufacturer of a pesticide may be unnecessary and ethically undesirable. Obviously, report number: DFOE-AM-19-2004 of October 20, 2004, from the Contraloría General de la República, was issued prior to the entry into force of international agreements on test data protection and before the incorporation of the principle of non-repetition of test data by the FAO and WHO. (…)

This principle is a fundamental principle in the registration process, not only because it enshrines at a normative level a thesis, based on science and chemistry, that we in the generic industry have historically held, in the sense that chemical equivalence between two IAGTs makes it unnecessary to require toxicological, ecotoxicological, or environmental fate and behavior studies. This general principle must be observed and complied with by national authorities; therefore, registrants are empowered to invoke said principle when requesting an exemption from any of the tests or studies established in the Registration Regulation. In this regard, we must remember that unwritten norms (custom, jurisprudence, and general principles of law) are useful for the interpretation, application, and integration of the written legal system, such that in cases of normative insufficiency or gaps, general principles constitute a source of law." It refutes the aforementioned CGR report No. DFOE-AM-19-2004, pointing out that in 2013 a reform to the FAO's International Code of Conduct on the Distribution and Use of Pesticides took effect, which is why it considers the report inapplicable. It affirms that said Code promotes that States establish a pesticide registration and control system and mentions opinion C-215-2013 of the PGR, which refers to this international standard. It complements the above by indicating that a CGR report cannot grant governmental powers related to pesticide registration to other ministries and insists that competence in pesticide matters corresponds to the SFE, according to the Ley de Protección Fitosanitaria. It states that the reform carried out by Decreto Ejecutivo No. 41481-MAG on Decreto Ejecutivo No. 39995-MAG does not allow the registration of new pesticides—new, according to Art. 15.10 of CAFTA—and that the reform implemented is linked to the modification of deadlines and administrative requirements.

It insists that the MAG, through the SFE, is the competent body for the reception, verification, and evaluation of registration certificates, as a governmental power originating from the Ley de Protección Fitosanitaria, excluding the participation of other bodies such as the Ministry of Health and MINAE:

"As long as the SFE adjusts its structure and has within the Registration Unit the areas of Chemical Evaluation, Toxicological Evaluation, and Ecotoxicological Evaluation, it could not even be insinuated that there is a deterioration in environmental regulations, because as we have already explained, it was the legislator who, in the Ley de Protección Fitosanitaria, conferred on the MAG, through the SFE, the competence to create and manage the registration of agricultural-use pesticides. Therefore, this deconcentrated body must have a technical, organizational, and administrative structure that ensures not only the quality and efficacy of pesticides but also their safety, so that both the environment and human health are protected, guaranteeing that the use of these substances does not represent unacceptable risks to health and the environment." Regarding the plaintiff's analysis of the articles of Decreto Ejecutivo No. 41481-MAG of December 10, 2018, it states the following:

Regarding Art. 1 As observed, said text compared with the unamended text maintains its scope of application in the sense that this regulation cannot be used to register new pesticides (new according to the concept of Art. 15.10 of CAFTA and Art. 8 of the Law on Undisclosed Information) and the only thing that changes is what is related to deadlines, and one of the administrative requirements. The plaintiff objects to the issue of deadlines which, as we reiterate, is a matter of legality that must be resolved in another venue and not in a constitutional one. It is important to make clear that it is the competent authority that determines what the deadlines are within which certain acts must be performed and the deadlines that the administered party must meet for their proceedings under the norm. It also proceeds to analyze the issue of requirements and even issues an opinion on what, according to the plaintiff, the requirements should be, the procedure for evaluating them, and which authorities should intervene in these processes. This is not only procedurally unacceptable but legally there is a scheme of competencies, and expressly in Law No. 7664, it is conferred upon the MAG and the SFE. From the relationship of articles 23, 24, 25, following and concordant, of the Ley de Protección Fitosanitaria, with Art. 11 of the Constitution and articles 11 and 59 of the LGAP, it can be affirmed that the procedures for reception, verification, evaluation, and issuance of registration certificates constitute a governmental power conferred by the legislator on the MAG through the SFE. Therefore, it considers that in this matter it would be prohibited to confer governmental powers by decree, just as it would be unacceptable from a strictly legal perspective to base, on general laws related to the environment or human health, a Decreto Ejecutivo granting competencies to the Ministry of Health and MINAE, when the legislator, in a specific law (Ley de Protección Fitosanitaria), already provides not only the body responsible for exercising those competencies but also, by an express norm (Art. 23 of the Ley de Protección Fitosanitaria), establishes that the requirements for the registration of chemical, biological, biochemical substances, adjuvants and related substances, and application equipment for agricultural use will be established in the regulation to the Ley de Protección Fitosanitaria. Therefore, it is clear that in application of the principles of legal hermeneutics, all the rules, requirements, and procedures for registration are those contemplated in the regulation to that law.

Regarding Art. 2 The plaintiff limits itself to objecting to matters of mere legality and omits addressing the alleged unconstitutional aspects of the norm it challenges. Even from a plain and simple reading of the text, it is evident that the plaintiff's assertion that registrations are being granted for new products through this regulatory norm is fallacious. Nor is it true, as the plaintiff states, that agronomists are in charge of reviewing chemical information; but, beyond the inaccuracies and fallacies incurred by the plaintiff, what is evidenced is that its allegations concern administrative aspects and mere legality, which are not for the Constitutional Chamber to resolve but rather for the ordinary jurisdiction.

Regarding Art. 3 Regarding aspects related to deadlines, with "unacceptable audacity," it refers to institutional workloads, forgetting that what it is raising and submitting to the Chamber's knowledge is an unconstitutionality action against a norm issued via Decreto Ejecutivo. Thus, it confirms that we are facing a challenge by the plaintiff of administrative aspects and mere legality in a jurisdictional venue not competent to hear these matters. It draws attention to the plaintiff's mention of a technical aspect that reveals its profound ignorance of the matter regulated by the challenged decree and, out of respect for science and the registration system, explains very succinctly:

"As we had already pointed out, in Costa Rica before January 10, 2007, the registration system established that a formulation could be registered without needing to have a registration of the raw material, that is, its technical-grade active ingredient (IAGT). After that date, it was established that every formulation, prior to being registered, required the registration of its IAGT. This means that currently a huge number of around one thousand five hundred formulated products are not associated with a manufacturer. That is why Decreto Ejecutivo No. 39995-MAG of December 15, 2016, and its reform (Decreto Ejecutivo No. 41481-MAG of December 10, 2018, published January 11, 2019, scope number 8 of the Diario Oficial La Gaceta), establishes an updating process that will allow the registration system to guarantee that every formulation marketed in the country will be associated with a manufacturer of the IAGT. This manufacturer update does not imply that registration is being granted to a new product, but rather that through this updating process, the authority will have the necessary information to determine if the technical material with which that formulated product is made does not contain relevant impurities and also complies with the international specification that every IAGT must meet for the formulation of pesticides. Thus, what the plaintiff indicates regarding a lack of technical or scientific basis and the confusion made with registration under the equivalence modality is incorrect, because what the process proposes is not an equivalence but an update of the information of a valid registration of a formulated product that does not have an IAGT manufacturer associated with its registration. Remembering that, by virtue of Article 3, it is not authorizing a new product but associating a manufacturer with that formulation that already has a registration and is marketed in the country." The plaintiff's technical and scientific ignorance of the matter leads it to equate the updating process established by Decreto Ejecutivo No. 39995- and its reform No. 41481-MAG, with the registration by equivalence modality established in the Technical Registration Regulation (Decreto No. 40059-MAG-MINAE-S). Furthermore, the plaintiff organization forgets that in Costa Rica, the registration by equivalence modality is based on chemical equivalence, so technical information is not required, as established by the equivalence registration systems promoted by the FAO.

Regarding Art. 5 When analyzing Art. 5, the plaintiff confuses the concept of manufacturer with that of formulator, such that all the hypotheses, objections, and analysis it makes of said norm are not applicable to the legal situation regulated by the updating of formulators in Decreto Ejecutivo No. 39995-MAG of December 15, 2016, and its reform No. 41481-MAG.

Regarding Art. 6 Art. 6 of the challenged decree guarantees, in its current wording, first, that Costa Rica will cease to have registrations for an indefinite term, since from the update onwards, all registrations of IAGT and formulated products will have a validity of 10 years, imposing the obligation to renew them. It will not be as it is now, where being for an indefinite term they do not need to be renewed because they have no expiration date; second, that it will be guaranteed that all formulations currently sold in the market will have an associated manufacturer, and not as now, where the sites and origins of manufacture of raw materials are unknown; third, that every IAGT used in the country for the formulation of products authorized for commercialization here has accredited its purity and that it does not have relevant impurities above the international specification; fourth, that all IAGTs used in Costa Rica comply with the international conventions signed by Costa Rica (Annex III of the Rotterdam Convention, the Stockholm Convention, or the Montreal Protocol); and fifth, that the SFE will create a database of toxicological, ecotoxicological, and environmental fate information for the technical-grade active ingredients that are registered and do not have valid periods of test data protection. It is very important for the SFE to have a bank of information for molecules that are not new and whose test data are free for use because they do not have valid protection periods. It is necessary for companies that have toxicological, ecotoxicological, and environmental fate information for technical-grade active ingredients, which are not new, to provide information they have managed to compile that will help the SFE in the future to build a complete toxicological, ecotoxicological, and environmental fate and behavior profile, complete, to have a reference profile for registrations by equivalence.

Regarding Art. 7 The current text bears no relationship or congruence with the comments and reckless assertions made by the plaintiff about this specific article. Regarding the assertion that this norm reverses the principle of the burden of proof or the precautionary principle, it is rejected "absolutely and categorically," not only because it is a matter of legality to be discussed in the ordinary jurisdiction, but also because the current text of Art. 7 is supported by reiterated opinions of the PGR and rulings of the Constitutional Chamber. It considers it incorrect and reckless to maintain, as the plaintiff does, that the questioned decree violates the precautionary principle in environmental matters, just as it is incorrect to indicate that the burden of proof is reversed.

It points out that the norm challenged does not allow or make it possible to grant registrations for new products that are already marketed in the market, as its scope of application is very clear and it is only feasible to apply it to valid registrations that were granted under regulations (legal or regulatory) different from Decreto Ejecutivo No. 3495-MAG-SMINAE-MEIC and its reforms. That is, "it is not feasible to register new IAGTs or new formulations with new IAGTs," and the IAGTs granted must necessarily and inevitably correspond to some of the formulations already sold on the market. With this regulation, registrations of IAGTs will not be granted, much less formulations that are not already on the market. Regarding registered agrochemicals currently marketed in the country, there is no additional or resulting danger from its application concerning human health, the environment, or the biological efficacy of the pesticide. Therefore, it is not correct to state that with the application of the decree, the registrations updated in their files pose an additional risk to health, the environment, or agriculture, since all, absolutely all, IAGT registrations granted must necessarily and inevitably correspond to some of the formulations already sold on the market, and regarding these formulations, the Ministries of Health or Environment have broad and indisputable competencies and powers to adopt the pertinent measures to prevent damage to health or the environment, not only by resorting to the jurisdictional route to annul the administrative acts under which the registration was granted, but even by precautionarily or provisionally preventing any act that implies or entails the importation, manufacture, handling, storage, transportation, commercialization, supply, and use and application of the product considered to damage health or the environment. Certainly, the challenged regulation is only applicable to products that have already been granted a registration and therefore can be commercialized. All those products to which the decree under analysis applies were registered because they met the requirements, procedures, and evaluations established by the regulations in force at the time their registration was granted, which is why those products are covered by a registration, and that registered legal situation cannot be ignored by the active Administration. In this regard, the PGR was already clear and forceful in opinion number C-255-2009, stating that pesticide registrations (IAGT or formulated) that currently hold a valid registration are therefore authorized to be marketed in the country. The above proves that there is no violation of the precautionary principle in environmental matters, nor is the principle of the burden of proof being reversed, since as these are products that are marketed under a registration, this implies that the product already met the requirements and procedures established by the regulations in force and was also evaluated according to those regulations by the competent authorities. Therefore, it is clear and indisputable that the active Administration must respect that legal situation and the right of the administered party, so that, to annul the act that conferred it, it must follow the procedures set out in the Código Procesal Contencioso-Administrativo, aimed at declaring the harmfulness and annulment of the registration act, and may even, as a precautionary measure, prevent, while the harmfulness is declared, the importation, manufacture, handling, storage, transportation, commercialization, supply, and use and application of the product considered to damage health or the environment.

Regarding Art. 11 The plaintiff provides nothing more than a transcription of parts of a report from the controlling entity, absolutely taken out of context and not applicable to the specific situation. The homologation of formulations proposed in Art. 11 of the challenged decree is based on the manual of specifications of the FAO and the World Health Organization (WHO) for the elaboration of pesticide specifications.

After the previous particular analysis of the challenged norms, it reiterates the attribution of competence in the matter of registering agrochemical substances that various legal and regulatory norms assign to the MAG through the SFE and, in this sense, provides transcriptions of opinions of the PGR and rulings of the First Chamber of the Corte Suprema de Justicia.

Regarding the plaintiff's conclusions The regulation under examination applies only to old products, that is, products for which registrations of IAGT or formulated product have already been granted, and many of those registrations were granted for an indefinite term. This means they do not require the updating decree to continue commercialization. Therefore, rather than facilitating, it is about imposing an obligation on them to update their information and provide data and studies that demonstrate not only the provenance and origin of the technical materials and associated formulations but also the confidential chemical information that allows the registration authority, specifically the SFE, to have at its disposal the confidential chemical information on purity, impurities, synthesis method, etc., of their technical materials, both as regards manufacturers and formulators. That confidential chemical information demonstrates if the IAGT has impurities of toxicological or ecotoxicological relevance that could affect health or the environment. That information is not currently available in the registrations that must be updated.

Depending on the relevant impurities and their concentration, the registration authority can make regulatory decisions regarding the continuation or not of a registration or of a manufacturer of a technical material of a formulation marketed in Costa Rica.

The plaintiff maintains or implies, without substantiating it, that every IAGT manufacturer must provide its own test data, meaning that each manufacturer must conduct chronic, subchronic toxicological, ecotoxicological, and environmental fate and behavior studies. Thus, it seeks to obligate the manufacturers of IAGTs used in pesticide formulation to conduct these studies (the plaintiff does not explain why manufacturers of active ingredients used in human medicines are not asked for the same). This pretension outlined by the plaintiff is absolutely censurable by the FAO and the WHO, since both international organizations, in the Manual on the Development and Use of FAO and WHO Specifications for Pesticides, have incorporated the principle of non-repetition of studies, a principle incorporated in Considerando XIII of Decreto Ejecutivo No. 40059-MAG-MINAE-S.

Nor is it true that the registered technical materials and formulated products have never been evaluated, as the plaintiff recklessly asserts in its conclusions; all registered products were registered after verifying that they met the requirements established by the regulations in force, and the MAG and the SFE could not, as the plaintiff pretends, ignore this legal situation and the rights of the administered parties.

The technical, philosophical, and legal basis of both Decreto Ejecutivo No. 39995-MAG and its reform No. 41481-MAG of December 10, 2018, is found in the recitals and legal part of both norms. In this case, the Ley de Protección Fitosanitaria No. 7664, which aims to regulate the use and management of chemical, biological, or related substances and equipment for applying them in agriculture; also, their registration, importation, quality, and residues, simultaneously seeking to protect human health and the environment, all of which must be registered in the registry that the SFE will create to have information on the characteristics of these and ensure their correct use in the country.

It is essential to guarantee the supply and continuity of commercialization of the products that currently hold a valid registration, making it necessary to update the information in their files on the characteristics of these and ensure their correct use in the country. The decree itself indicates in its recitals that the regulations prior to the validity of Decreto Ejecutivo No. 33495 MAG-S-MINAE-MEIC of October 31, 2006, and its reforms allowed the MAG to grant registrations for an indefinite term as well as the registration of formulated pesticides without requiring prior registration of the IAGT. This obliges the Poder Ejecutivo, within its constitutional and legal powers, to organize its registry, ordering the updating of the information of registrations inscribed for an indefinite term, having been granted under previous regulations.

The challenged norms aim to update the files with the information that was not requested at the time of their registration, through a re-registration process in accordance with Art. 50 of the Constitution.

The importance of Decreto Ejecutivo No. 39995-MAG and its reform, Decreto Ejecutivo No. 41481-MAG From a technical and scientific point of view: It allows the State to have all the information on purity, relevant impurities (name, content, and detection levels), total impurities, synthesis method, analytical methodologies to determine the IAGT and its relevant impurities, for all IAGTs registered as such or as components of a formulation, which were registered in Costa Rica under legislation and regulations different from Decreto Ejecutivo No. 33495-MAG-S-MEIC-MINAET. The confidential chemical information required by this decree is key and essential from an agronomic, toxicological, and ecotoxicological point of view, and it is unfortunately not incorporated into the files of these registrations. Much of the chemical information requested in the decree, especially that described in Articles 1 and 5, although it was presented during the revalidation process, is completely outdated, since between 5 and 10 years have passed since the information was provided, and the authorities have not yet reviewed, much less approved it.

It allows the Costa Rican State to have updated information on the formulation sites and origins, the name and physical location of the formulators, as well as the product components and the detailed description of the formulation processes for all formulated products currently marketed in Costa Rica.

From a chemical and scientific point of view: It guarantees that no formulated pesticide marketed in Costa Rica can be registered, and therefore marketed, if it does not have an associated IAGT that has levels of relevant impurities (those that have toxicological and ecotoxicological importance) exceeding the levels specified in international reference standards (FAO, EPSA, IUPAC).

From a legal point of view: It manages to bring old registrations (those not registered under Decreto Ejecutivo n.°33495-MAG-S-MEIC-MINAET) into line with registrations granted under the registration system (which establishes the registration of the IAGT as a prerequisite for the registration of a formulation). Consequently, all currently registered formulations will have their corresponding associated IAGT (with its current manufacturer, its origin, and production or synthesis site), duly registered. The information in the technical file is absolutely consistent, not only with the principle of non-repetition of studies promoted by FAO and WHO, but also with doctrine and comparative law. It provides legal certainty to registrants and agricultural producers regarding the supply of formulated products currently marketed. It constitutes the legal instrument that enables the application of the new registration regulation, by standardizing the validity of registrations and associating formulations with the current manufacturer of their IAGT and the current (national or foreign) formulator of the product.

From a political point of view: Another innovation and benefit of the regulation for updating files is that it will solve a problem that past administrations have failed to resolve, despite attempts to do so through temporary decrees (change of manufacturer) and revalidation processes. In Costa Rica, a very high percentage (perhaps 80% or 85%) of the formulations marketed do not have their respective IAGT associated with their registration. This not only leaves health and environmental protection in a state of vulnerability but also prevents registrants from improving their formulations or registering new ones. This is overcome with the new regulation. Now, with this decree, the problem of formulations lacking an associated IAGT registration is solved, which is of great merit for the current administration. The regulation for updating registration files constitutes a legal instrument of high political value. It resolves the problem and the uncertainty (technical and legal) affecting registrations that had been granted under regulations of varying rank, different from that established by Decreto Ejecutivo n.°33495-MAG-S-MEIC-MINAET. Through this new decree, the authority is empowered and provided with mechanisms to obtain technical and chemical information, guaranteeing that currently marketed pesticides do not pose an unacceptable risk to agriculture, health, or the environment.

From an agronomic point of view: It orders and updates the labels and leaflets with which formulations are marketed in Costa Rica. This ensures that the factors involved in the use of a formulated pesticide—namely, the concentration of the technical-grade active ingredient in the formulation, application doses, the period and number of treatments, the use of adjuvants, and the application methods and sites that determine the applied quantity, the treatment frequency, and the pre-harvest interval, as well as all factors inherent to the mode of use of a formulated pesticide—are accurately addressed. All this is a faithful reflection of the product file.

It requests that the appeal be declared without merit.

4.- The edicts referred to in the second paragraph of Article 81 of the Ley de la Jurisdicción Constitucional (LJC) were published in numbers 84, 85, and 86 of the Boletín Judicial, on May 08, 09, and 10, 2019.

5.- By a writing received at 10:05 a.m. on May 10, 2019, Julio Alberto Jurado Fernández appeared to respond to the hearing granted to the PGR, and stated the following:

Regarding Standing The party has standing to file this unconstitutionality action, as it appears in defense of diffuse interests, related to Articles 21 and 50 of the Constitución Política.

Regarding the Merits The subject matter of this constitutional process is closely related to another similar one, processed under file number 18-19039-0007-CO, and therefore the joinder of this process to the previously indicated one is suggested.

Before Decreto Ejecutivo n.°33495 of 2006 was issued, to register a formulated pesticide it was not necessary to previously register the technical-grade active ingredients required for that formulation, and registrations were granted without a defined term, nor were the same technical requirements demanded. As a result, Decreto Ejecutivo n.°33495 established a revalidation process for holders of IAGT registrations granted before the promulgation of said regulation to provide the SFE with the necessary information to sustain the validity of their registrations. Subsequently, Ley n.°8702 was enacted, establishing a revalidation process similar to the aforementioned decree, and Decreto Ejecutivo n.°33495 was repealed with the issuance of Decreto Ejecutivo n.°40059—the subject of another unconstitutionality action, processed under file number 18-009107-0007-CO. Later, Decreto Ejecutivo n.°39995 was issued, establishing another revalidation process for pesticide registration, subject to a deadline. Before this deadline elapsed, Decreto Ejecutivo n.°41841—the subject of this unconstitutionality action—was issued, extending the revalidation period to sixty months from its publication. The considerandos of said decree explain that the SFE suspended the application of Decreto Ejecutivo n.°39995 due to an inquiry from the SFE's internal audit to the PGR and that "due to a lack of procedure, it has not been possible to update the information for any of the registrations of technical-grade active ingredients (IAGT) and formulated products that do not have an IAGT registration and that were not registered in accordance with Decreto Ejecutivo n.°33495". In addition to modifying the period established in Article 1 of Decreto Ejecutivo No. 39995, some requirements and procedural aspects of said decree are varied, apparently based on the sixth considerando, which stated:

"That technical-grade active ingredients are used solely for the formulation of synthetic chemical formulated pesticides and that only by exception are they used directly in the field, and these exceptional situations are already regulated in the current technical regulations; therefore, the registration certificates for technical-grade active ingredients are only useful for authorizing, by the Servicio Fitosanitario del Estado, the importation of these as raw material for pesticide formulations in processing plants and not for direct field use".

Regarding the Constitutionality Analysis of the Challenged Rule As stated in the report for action n.°18-19039-0007-CO, the Procuraduría is not competent to assess strictly technical aspects and determine whether the requirements and information listed in the challenged rule are adequate or not for conducting a correct assessment of the environmental and health risk of pesticides. Therefore, in this respect, the constitutionality analysis must consider the technical information submitted to the file.

In the report for action n.°18-19039-0007-CO, the Procuraduría noted that the revalidation process under Decreto n.°33495 required certain technical requirements that were not contemplated by Decreto n.°39995, even though the considerandos of the latter acknowledge that it involves updating products that have not complied with the toxicological, ecotoxicological, and environmental fate information requirements established in international regulations and required since the entry into force of Decreto n.°33495. Therefore, based on the foregoing, it was indicated that if the technical reports submitted to the file confirm this and show that there are no technical criteria justifying the rule's content and determining that, with the required requirements, it is not possible to conduct an adequate assessment of the environmental and health risk, the principle of non-regression of environmental protection (principio de no regresión ambiental) and the principle of objectification of environmental protection (principio de objetivación de la tutela ambiental) would be violated, because the levels of environmental and health protection established by Decreto n.°33495 would be lowered without a study supporting the adoption of that measure. Furthermore, it was argued that the preventive principle (principio preventivo) would be infringed, since, by not requiring information allowing an adequate assessment of the environmental and health risk of the products, it is not possible to adopt measures aimed at avoiding, mitigating, or correcting the adverse effects that pesticides generate on the environment. And that, even, this would imply a violation of the precautionary principle (principio precautorio), since, without an adequate review of the health and environmental risk of pesticides, there would be no scientific certainty that they do not cause environmental harm.

In this case, firstly, the technical basis of Decreto n.°41481 that motivated the extension of the revalidation period by five more years must be assessed, and which justifies the possibility of continuing to market pesticides, even though they have not complied with the revalidation process and their effects on health and the environment have not been determined.

The submission of a consultation to the Procuraduría, contrary to what is indicated in the considerandos of the decree, does not suspend the application of the rules that are the subject of the consultation. Therefore, the consultation raised by the internal auditor of the SFE regarding several questions related to Decretos números 39461, 40059, and 39995-MAG, which gave rise to Dictamen n.°C-199-2017, did not imply the suspension of the revalidation process established by Decreto n.°39995.

Likewise, it must be technically assessed whether the requirements established by the challenged rule for the revalidation process allow for an adequate assessment of the environmental or health risk of the products. A mere comparison of the texts of Decreto n.°39995 and Decreto n.°41841 shows that the technical requirements contemplated by Decreto n.°33495 were not added; rather, some points were eliminated and modified.

For example, in Article 1, the acute toxicity studies and ecotoxicity studies that Decreto n.°33495 contemplated are still not required, and these are required only for cases where the manufacturer has changed and the product presents relevant impurities, which is determined according to international reference specifications and standards. Furthermore, in Article 1.1, the request for manufacturer update, the registration certificate issued by the authority of the country of origin, and the endorsement by a chemist for the qualitative-quantitative composition certificate were eliminated. In Article 1.2, the registration certificate issued by the authority of the country of origin was eliminated, and the way of indicating the chemical name in the analytical certificate of active ingredient composition was changed; and in Article 5, the country of origin certificate and the chemical endorsement of the qualitative-quantitative composition certificate and the analysis certificate of the formulated product were eliminated, while the possibility of proving, by means of a sworn statement from the registration holder, that the formulation composition has not varied and that an authorized active ingredient is used, is maintained.

Subject to what is provided in the technical criteria submitted, if it is confirmed that the challenged rule lacks a technical basis and that it relaxes the requirements and extends the revalidation process period, preventing a correct evaluation of the effects of pesticides and allowing their commercialization under those terms, the Procuraduría considers that the unconstitutionality action should be granted. Unless, as recommended in file n.°18-19039-0007-CO, the Chamber considers that the challenged decree does not undermine the SFE's powers to request any other pertinent and necessary information to conduct an adequate evaluation to determine that the product's use does not affect health or the environment, as has been indicated on other occasions.

In that same vein, the unconstitutionality of Article 2 must be declared if, based on the technical criteria submitted to the file, it is determined that the reduction of the period from three months to one month for the SFE to verify and analyze the submitted information and resolve the product update application and grant the registration certificate prevents an adequate assessment of the product's environmental and health risk. Without prejudice to what is resolved regarding that article, it is appropriate for the Sala Constitucional to clarify whether the rule applies that the figure of tacit approval (silencio positivo) does not operate in the case of environmental approvals or authorizations and that, therefore, the Administration's failure to comply with the established period would not imply the automatic approval of the product's revalidation.

Regarding the possibility of registering products using referenced information, the Procuraduría, in the report rendered in file n.°18-19039-0007-CO, considered that if it is confirmed that there is no technical support and that with the type of information required it is not possible to carry out an adequate assessment of the environmental and health risk, the articles contemplating that possibility would be unconstitutional, for violating the principles of objectification of environmental protection, the preventive principle, and the precautionary principle.

Furthermore, Voto n.°16937-2011 was noted, which declared unconstitutional subsection b) and the reference in the penultimate paragraph to said subsection b) of section 7.3.2 of Article 2 of Decreto Ejecutivo n.°33495, insofar as it allowed registration by equivalence of technical-grade active ingredient products using other registrations that did not have complete information as a reference profile, since for the registration of the latter, in addition to acute toxicity and ecotoxicity studies, additional chronic toxicology studies, ecotoxicological studies, and other studies on the abiotic environment were not required, as required by Article 5 of the Ley para la Importación y Control de la Calidad de Agroquímicos and the Manual on Development and Use of FAO and WHO Specifications for Pesticides (which applies according to the provisions of Article 44 of the Ley de Protección Fitosanitaria and Article 6.1.7 of the International Code of Conduct on the Distribution and Use of Pesticides of the FAO).

Based on the foregoing, although the Procuraduría is not a technical body in the matter, it can be stated that even though the challenged decree modifies Articles 1.2.b and 6 of Decreto n.°39995, which allowed product registration through referenced information, it maintains that possibility. For in Article 1.2.c, it allows the use of international specifications to prove that the technical material intended to be updated does not contain relevant impurities, stating in the fifth considerando that international specifications and standards are a technical and scientific reference for determining that technical-grade active ingredients do not contain relevant impurities at levels above the international standards or specifications, and that only these relevant impurities have toxicological or ecotoxicological relevance that could cause harm to health or the environment.

In the same vein, Article 3 provides that for formulated pesticides that do not have an associated technical-grade active ingredient registration, that registration will be granted directly when the manufacturer of that active ingredient has been updated.

Article 6 provides that once the requirements are met, registration will be granted for 10 years and that, during that period, the SFE will verify that the already approved registrations of technical-grade active ingredients have chemical equivalence with the reference profile of that active ingredient, and that, in the absence of this profile, it must be verified that they do not contain relevant impurities.

Article 11 endorses the homologation of labels and leaflets with those of other already registered products that have the same active ingredient and the same concentration, without considering the effects that the other product components or the form or method of preparation could have.

The challenged rule does not establish how the information will be verifiable, how to determine which international specification can be used, how to determine product equivalence, nor whether the reference profile to be used must be a registration that has complete information, and therefore, covers acute toxicity studies, ecotoxicity, chronic toxicology, ecotoxicological studies, and other studies on the abiotic environment as required by Article 5 of the Ley para la Importación y Control de la Calidad de Agroquímicos and the Manual on Development and Use of FAO and WHO Specifications for Pesticides.

By not precisely establishing the rules to which the competent authority must adhere to verify the information, it is possible that the updating of registrations with referenced information that does not meet the indicated requirements is allowed, and, therefore, this would imply the updating of product registrations without a prior evaluation of the environmental and health risks of their application.

If the foregoing is verified, according to the technical criteria issued for this purpose, this would imply the unconstitutionality of the articles that allow the use of referenced information without an adequate determination of equivalence.

Regarding the exclusion of MINAE and the Ministerio de Salud from the registration update process, the Procuraduría indicated that the revalidation process regulated by Decreto n.°33495 stipulated that the competent institutions could request additional information, and this implies the participation of those Ministries. Therefore, it was considered that the non-participation of the corresponding technical departments of those ministries in the process established by Decreto n.°39995 represents a setback in the level of protection and a violation of the principle of objectification of environmental protection, as it would allow the updating of registrations without the technical criteria of those entities within their field of competence.

The same must be said of the challenged decree, as it carries that same defect by not including the participation of those Ministries. This is unless the Chamber considers that the powers attributed to other bodies in their respective enabling laws are not repealed or modified by the challenged rule, and that the SFE, within the exercise of its legal powers, can and must request the participation of any specialized technical body to verify that a pesticide does not threaten health and the environment.

Regarding the improper reversal of the burden of proof that, in the plaintiff's opinion, is contemplated in the reformed Article 7, the Procuraduría reiterates that this does not undermine the constitutional duty that, by virtue of the precautionary principle, the competent authorities have to apply the powers established in Articles 25 and 30 of the Ley de Protección Fitosanitaria and Article 5 of the Ley para la Importación y Control de la Calidad de Agroquímicos, to "deny, suspend, or cancel the registration of chemical, biological, or related substances," "restrict or prohibit the importation, transit, redestination, manufacture, formulation, repacking, repackaging, storage, sale, mixing, and use of chemical, biological, or related substances and application equipment for agricultural use, when justified for technical reasons," and to "prohibit the circulation or order the destruction of products that do not comply with quality standards, as well as take other measures aimed at improving the quality of agrochemicals." In conclusion: The analysis of this unconstitutionality action involves assessing whether the defects attributed to Decreto n.°39995 in unconstitutionality action n.°18-19039-0007-CO have been remedied in the challenged decree, or whether, on the contrary, they persist or are aggravated.

6.- By a writing received in this Sala Constitucional at 6:42 p.m. on May 20, 2019, Mr. Jaime Enrique García González, Doctor of Agricultural Sciences and professor of the Agriculture and Environment Area of the Environmental Education Center of the Universidad Estatal a Distancia, a specialist in pesticides, files a joinder as coadjuvant in this process. He proceeds to propose documentary evidence, consisting of Resolution 153-2014-VI of the Tribunal Contencioso Administrativo, as well as Resolution 1030-2018 of the Sala Primera of the Corte Suprema de Justicia.

7.- By a writing received at 11:04 a.m. on May 29, 2019, Mr. Jorge Arturo Osborne Escalante, identity card no. 1-0417-1413, in his capacity as legal representative of the Asociación Cámara Nacional de Bananeros ("CANABA" hereinafter), with legal entity ID no. 3-002-056468, appears in this process as a passive coadjuvant. Regarding his standing, he argues that it derives from CANABA's purpose, which is the defense of its associates' interests linked to the banana activity in the country. He considers that he has a legitimate interest, derived from the use of pesticides to control pests and diseases in the cultivation and marketing of bananas. He claims that the associates of said association use registered pesticides as part of their commercial activity, which allows them to maintain their productivity and exports; hence, he considers that he has sufficient legitimate interest to appear as a passive coadjuvant in this process. On the other hand, he believes that the plaintiff lacks active standing, as he does not indicate how Decreto Ejecutivo n.°41481-MAG affects him, and points out that the certification of legal representation provided does not verify the date of issuance, and therefore believes it should not have been admitted. Regarding what the plaintiff calls the objective of the action, CANABA's legal representative says that the writing contains a series of allegations that lack foundation. He argues that now an obligation is imposed to update information and provide data and studies concerning the technical materials and formulations made, as well as the delivery of confidential information to the SFE. In this, he partially agrees with the MAG report, in the sense that it is the law that imposes the issuance of the executive decree in question, for establishing requirements and procedures for the registration of chemical, biological, and biochemical substances. He mentions Dictamen C-175-2005 of the PGR. Regarding the background, he refutes the plaintiff's assertions, as the executive decree subject to this action does not seek to grant more time to the business sector for the commercialization of agrochemicals. He considers that, rather, obligations to update information are imposed on these companies. He says that this is not a case of concurrent jurisdiction between the MAG, the Ministerio de Salud, and MINAE, as Ley n.°7664 grants jurisdiction over pesticide registration matters to the SFE. He adds that report DFOE-AM-19-2004 is inapplicable, contrary to what the plaintiff asserts. He reiterates what was said by the MAG regarding the so-called principle of non-repetition of studies and that the dispute should be resolved in the legality venue and not the constitutionality venue. He reproduces the argument held by said ministerial body to the effect that the decree subject to this process does not allow granting registrations for new products, as well as the argument of consolidating the legal situation derived from the registration. He rejects the assertions made by the plaintiff through the conclusions present in the filing. He requests that the unconstitutionality action be declared without merit. He provides as documents the aforementioned MAG report, as well as the legal status certification of the association in question.

8.- By a writing received at 1:22 p.m. on May 29, 2019, Mr. Juan Rafael Lizano Sáenz, identity card no. 1-0379-0262, in his capacity as president of the Cámara Nacional de Agricultura y Agroindustria (CNAA), legal ID no. 3-002-051316, files a passive joinder in this process. After recounting the factual background, he indicates that his standing as coadjuvant stems from the purpose of the CNNA, which brings together producers, businessmen, and entities of the agricultural and agro-industrial sector. He states that the association comprises different associates from various actors in the agricultural sector, and that precisely from there his standing derives, as their commercial activity involves the registration and application of pesticides. He indicates that the process affects the interests of the different groups that make up said association, which confirms the sufficient legitimate interest for purposes of admitting the passive joinder. After reiterating the plaintiff's arguments, he begins his exposition regarding the inadmissibility of the unconstitutionality action. Firstly, he refers to the fact that the reform operated through Decreto Ejecutivo n.°41481-MAG was carried out in compliance with what is stipulated in technical and scientific studies, according to international standards. As for the criteria of other bodies such as the PGR and MINAE, he indicates that this Sala Constitucional cannot assess strictly technical matters and cites Resolution n.°7009-2019 in his favor. He insists that when it comes to assessing the validity of technical and scientific studies in environmental matters, it is appropriate to discuss it in a venue other than the constitutional one, and invokes Resolutions numbers 6922-2008 and 7009-2019. He claims that such assessments escape the summary remedy of amparo. On the other hand, he refers to the power granted by various legal, regulatory, and constitutional norms to the Poder Ejecutivo strictly speaking for the issuance of executive decrees and, given that these norms grant power to the MAG, they do so to the exclusion of other bodies, and therefore rejects the arguments of the plaintiff. He requests that the joinder be admitted and that this unconstitutionality action be rejected on the merits. He attaches the certification of his legal representation.

9.- By a writing received at 2:50 p.m. on May 29, 2019, Mr. Federico Lizano González, identity card no. 1-0793-0229, in his capacity as legal representative of the Cámara de Insumos Agropecuarios de Costa Rica, legal ID no. 3-002-045217, files a passive joinder in this process. Regarding his standing as coadjuvant, he argues that his represented party is an organization comprised of companies from the sector supplying inputs and technology for the agricultural sector. Hence, the validity of Decreto Ejecutivo n.°41481-MAG directly affects the interests of the Cámara and its affiliates. This is because its associates carry out procedures for the registration of agricultural inputs, and they indicate that what this Sala Constitucional resolves directly impacts the work of the Cámara and its associates. Regarding the merits of the case, he believes the action should be declared without merit. He mentions that the regulatory power held by the Poder Ejecutivo has constitutional rank and is not subject to more limits than legal regularity and the reservation of law. On the other hand, he claims that registrations by incorporation and by equivalence are based on the rationalization of state intervention; using this information obtained from high standards does not endanger the environment or health. He argues that the decree in question refers to products that are already on the market and that have already been duly evaluated. Regarding the reduction of timeframes, he believes that said rule is not contrary to Constitutional Law, as it fits within the framework of regulatory improvement and better public service provision. He requests that the joinder be admitted and that this unconstitutionality action be declared without merit on all grounds.

10.- By a writing received at 2:40 p.m. on May 29, 2019, Mr. Manrique Constela Umaña, in his capacity as unlimited general attorney-in-fact of Polymer S.A., files a passive joinder in this constitutionality process.

To support its standing as a coadjuvant, it states that the company is engaged in the production of plastic packaging for industry, agriculture, and personal consumption. It affirms that the legitimate interest in relation to this action derives from the fact that they frequently must request the registration or revalidation of agrochemical or agrobiological products. As to the merits of the matter, they request that the unconstitutionality action must be rejected outright, since it does not consider that it meets the admissibility requirements. It deems that the interest pursued by the claimant party is individual and direct and that in truth it is not acting in defense of the environment or the right to health. It mentions that in truth the claimants intend to attack norms that they consider contrary to their economic interests and cites in defense of its arguments various resolutions of the Constitutional Chamber, including resolution No. 8470-2007. It considers that the claimant party lacks active standing in this process and that therefore it must be rejected outright. On the other hand, it maintains that the brief lacks adequate substantiation since it proceeds to reiterate the arguments already put forth in the process processed under case file 18-19039-0007-CO. In another vein, it suggests that this process be consolidated with the one processed under said case file and indicates that the challenged norms should not be suspended, as the claimant party requested. Afterwards, the brief refers to the constitutionality of the norms in question. In the first place, it reiterates what has already been said about the constitutional assignment of regulatory power in the hands of the Executive Branch, which it supports with doctrinal citations. It points out that in accordance with Law No. 7664, it is up to the MAG to regulate said norm, due to the organizational and technical structure it must have. It explains the scope of the principle of legality and its relationship with competence, based on doctrine and on opinions of the PGR, applying the foregoing to competence in phytosanitary matters and under the terms of the Ley de Protección Fitosanitaria. It indicates that the SFE has the technical specialty for the development of its competencies related to the control of chemical, biological, or related substances for agricultural use. It points out that only the MAG is the one with the competence to issue an adequate opinion on the registration or revalidation of products for agricultural use. It dismisses the claimant's reproaches regarding whether the decree that is the object of this process benefits producers, since it rather considers that it conforms to the principles of public service, for which it brings up Art. 4 of the LGAP and resolution 5600-2005 of this Constitutional Court. It mentions that in no way does the reduction of timelines imply a favoring of companies selling agrochemicals; on the contrary, it is due to the technical criterion that the SFE holds, in accordance with the principles of efficacy, efficiency, and speed. It complements said argument with the application of Law No. 8220. It deems that the reduction of timelines is not contrary to the fundamental rights of health and environmental protection, which it supports with case law of this jurisdictional body. It points out in this brief that the elimination of requirements is not unconstitutional, as it indicates a lag in the technical regulations in question, derived from what it considers a poor conception of environmental and sanitary protection. It explains the difference between formulated pesticide and technical grade active ingredient, as well as the distinction between registration by incorporation and registration by equivalence, and alleges that the decree in question does not eliminate requirements necessary for the protection of health or the environment, but rather establishes rational regulations consistent with the great public utility derived from the registration of agrochemical products. It requests that the action be rejected outright and, should this request not be accepted, that it be consolidated with case file No. 18-19039-0007-CO. It also requests that the unconstitutionality action be declared without merit in all its extremes, as well as an interpretation of the decree in question in accordance with the Political Constitution, in the event that the Constitutional Chamber deems that the application of the decree in question transgresses constitutional norms and principles.

11.- The Presidency of the Constitutional Chamber, through the resolution of 3:48 p.m. on May 30, 2019, resolved matters pertaining to the coadjuvancies:

"In the specific case, the petitioner Enrique García González appeared on May twentieth, two thousand nineteen, however, he did not succeed in proving his interest to appear as a coadjuvant in the present matter, hence his request cannot be considered accepted, in view of the provisions of Article 83 of the Ley de la Jurisdicción Constitucional.

On the other hand, the coadjuvants Constenla Umaña, Osborne Escalante, Lizano González, and Lizano Saénz appeared on May twenty-ninth, two thousand nineteen and request to be held as coadjuvants because they consider that what is resolved in the present unconstitutionality action may eventually have an impact on their commercial activities. Consequently, and since the first publication of the notice occurred on May eighth, two thousand nineteen, the proper course is to hold them as coadjuvants within this matter." Likewise, the hearings granted to the PGR and the MAG were deemed answered.

12.- By brief filed on August 27, 2019, the Minister of Agriculture and Livestock, Luis Renato Alvarado Rivera, requested clarification of the order of 2:45 p.m. on April 8, 2019, regarding the effects on the administrative procedures for updating registration case files. Likewise, he insists on the following:

"We do not omit to express to the Honorable Chamber that the challenged norm does not refer to new registrations to be granted, but to an update of the information of current registrations, which were granted in the past, after having passed the evaluation of the Ministries of Agriculture and Health. Furthermore, it does not refer to products that were authorized for the first time in Costa Rica on a worldwide level, but rather that they had already been evaluated comprehensively (in the agronomic, health, and environmental aspects) and approved by regulatory entities of the countries of origin of the same, such as the United States of North America, the European Union, Japan, among others.

The update proposed in the challenged norm rather serves to order the national regulatory system, since it commands that the source information in the current registration case files be brought up to date." 13.- By a brief submitted on November 1, 2019 (without the corresponding signature), Mr. Henry José Picado Cerdas, identity card No. 3-0403-0272, in his capacity as an interested citizen, proceeds to request appearance in the present process.

15.- The prescriptions of law have been complied with in the proceedings.

Drafted by Magistrate Garro Vargas;

WHEREAS

I.- ON THE LAST COADJUVANCY PETITION In a memorial received at the Secretariat of the Chamber on November 1, 2019, a document was submitted that lacks a signature, supposedly signed by Mr. Henry José Picado Cerdas, identity card No. 3-0403-0272. He only stated that in his capacity as an interested citizen, he requested appearance in the present process. Said petition is inadmissible for several reasons. As already noted, the document lacks a physical or digital signature that would allow the validity of the petition to be corroborated in a process that is formal in nature, such as the unconstitutionality action. In the second place, the party does not substantiate what motivates his desire to appear in the process and, lastly, if it is considered to be a coadjuvancy, it was filed extemporaneously. Therefore, the petition is rejected.

II.- ON THE ADMISSIBILITY OF THE UNCONSTITUTIONALITY ACTION. STANDING On this particular, it must be pointed out that Art. 75, paragraph 2 of the Ley de la Jurisdicción Constitucional (LJC), establishes that the prior pending case will not be necessary when due to the nature of the matter there is no individual and direct injury, or if it involves the defense of diffuse interests, or those that concern the community as a whole. In this sense, the Constitutional Chamber, in its judgment No. 2001-8239, referred to diffuse interests, in the following terms:

"According to the first of the assumptions provided for by paragraph 2 of Article 75 of the Ley de la Jurisdicción Constitucional, the norm that is questioned must not be susceptible to concrete application, which would later allow the challenge of the applicable act and its consequent use as a base matter. (...) In the second place, the possibility of resorting in defense of diffuse interests is provided for (...) Diffuse interests, although difficult to define and more difficult to identify, cannot be in our law - as this Chamber has already stated - merely collective interests; nor so diffuse that their ownership is confused with that of the national community as a whole, nor so concrete that in the face of them, determined persons or personalized groups are identified or easily identifiable, whose standing would derive, not from diffuse interests, but from corporate ones that concern a community as a whole. It involves then individual interests, but at the same time, diluted in more or less extensive and amorphous sets of people who share an interest and, therefore, receive an injury, actual or potential, more or less equal for all, so it is rightly said that it involves equal interests of the groups found in certain circumstances and, at the same time, of each one of them. That is, diffuse interests partake of a dual nature, since they are at once collective - for being common to a generality - and individual, so they can be claimed in such character. (...) In summary, diffuse interests are those whose ownership belongs to groups of people not formally organized, but united based on a given social need, a physical characteristic, their ethnic origin, a given personal or ideological orientation, the consumption of a certain product, etc." In the present matter, the claimant invokes his standing by way of abstract control of constitutionality and invokes the defense of diffuse interests, since he appears in protection of the right to a healthy and balanced environment and the right to health of the population, related to the registration of pesticides that have evidenced impact on these. Consequently, such circumstance constitutes in favor of the petitioner direct standing for the filing of the present process, for invoking the defense of interests that concern the national community as a whole.

For the foregoing, the acknowledgment and resolution of the present unconstitutionality action by way of abstract control is admissible.

III.- ON THE OBJECT OF THE ACTION This action aims to resolve the grievances of unconstitutionality raised against Executive Decree No. 41481-MAG, called "Reforma Reglamento para la actualización de la información de los expedientes de registro de ingrediente activo grado técnico y plaguicidas formulados" (Reform Regulation for the Update of Information of Registration Case Files of Technical Grade Active Ingredient and Formulated Pesticides). Due to the length of the norm, its complete content is not cited here, but rather the provisions will be transcribed and the grievances will be addressed specifically in the respective whereas clause.

In general terms, it is claimed that the decree implies a benefit to pesticide marketers, since it extends the time to five years without said products having to be subjected to a risk evaluation. It is claimed that this type of decree only seeks to give more time to companies selling agrochemicals so that they continue with the process of marketing and using substances that are dangerous and that can cause serious damage to the health of the Costa Rican population, affect biodiversity, and harm the environment, since the registrations have not been evaluated comprehensively. In other words, that the products in question do not have the chronic toxicology study and that none of these registrations have had the ecotoxicological assessment performed and many might not be working at the doses at which they were registered. Furthermore, that the decree lacks technical substantiation on the matter of pesticides and seeks to make the requirements more flexible, to the detriment of the life and health of people. The issue of the timelines provided for the submission and resolution of the petitions is questioned, as well as the fact that the authorities of the Ministry of Health and MINAE were excluded from the process.

Previously (see judgment No. 2022-026651), this Chamber took note that in the interim of the processing of this action, new executive decrees were issued that could have an impact on the validity of this regulation. Specifically, in Executive Decree No. 43469 of April 6, 2022, "Reglamento técnico RTCR 504:2021. Reglamento para el Registro de Insumos Agrícolas. Plaguicidas Sintéticos Formulados, Ingrediente Activo Grado Técnico, Coadyuvantes, Sustancias afines y Vehículos Físicos de Uso Agrícola" (Technical Regulation RTCR 504:2021. Regulation for the Registration of Agricultural Inputs. Formulated Synthetic Pesticides, Technical Grade Active Ingredient, Adjuvants, Related Substances, and Physical Carriers for Agricultural Use), two transitory norms were established that provide that the Executive Branch will promulgate a new specific technical regulation that regulates the updating of registrations:

"TRANSITORIO 5. The Executive Branch within a period of six months counted from the date of entry into force of this regulation shall promulgate a specific technical regulation that regulates the update of registrations of technical grade active ingredient and formulated synthetic pesticides, granted based on a regulatory body distinct from this regulation, Executive Decree No. 33495 MAG-SMINAE-MEIC 'Reglamento sobre Registro, Uso y Control de Plaguicidas Sintéticos Formulados, Ingrediente Activo Grado Técnico, Coadyuvantes y Sustancias Afines de Uso Agrícola' (Regulation on Registration, Use, and Control of Formulated Synthetic Pesticides, Technical Grade Active Ingredient, Adjuvants, and Related Substances for Agricultural Use) or in Executive Decree No. 42769-MAG-S-MINAE 'Reglamento para optar por el Registro de Ingrediente Activo Grado Técnico mediante el reconocimiento de la evaluación de los estudios técnicos aprobados por las Autoridades Reguladoras de los países miembros de la OCDE y los países adherentes de la OCDE' (Regulation to Opt for the Registration of Technical Grade Active Ingredient through the Recognition of the Evaluation of Technical Studies Approved by the Regulatory Authorities of the OECD Member Countries and the OECD Adherent Countries). This technical regulation must at least consider the requirements, procedures, the prioritization of the update, the timelines according to the capacities of the AC and the competent reviewing authorities, as well as the technical establishment of reference profiles for the evaluation of all those products that were registered under regulations different from the cited ones. The registrant may make reference to information already presented in previous processes of revalidation, update, or renewal when applicable.

TRANSITORIO 6. Registrations granted based on a regulatory body distinct from this regulation, Executive Decree No. 33495 MAG-SMINAE-MEIC 'Reglamento sobre Registro, Uso y Control de Plaguicidas Sintéticos Formulados, Ingrediente Activo Grado Técnico, Coadyuvantes y Sustancias Afines de Uso Agrícola' or in Executive Decree No. 42769-MAG-S-MINAE 'Reglamento para optar por el Registro de Ingrediente Activo Grado Técnico mediante el reconocimiento de la evaluación de los estudios técnicos aprobados por las Autoridades Reguladoras de los países miembros de la OCDE y los países adherentes de la OCDE', must perform the update in accordance with the regulation established for these effects in accordance with transitorio 5. These registrations shall be considered valid for a period of five years from the entry into force of this regulation. Said period shall be deemed extended by an equal period for transactions that have been submitted for update in accordance with the regulation indicated in transitorio 5 if at the expiration thereof the competent reviewing authorities have not yet completed the review of the update transactions." Additionally, it is noted that through Executive Decree No. 43838-MAG-S-MINAE, a technical regulation was properly issued called "RTCR 509:2022. Insumos Agrícolas. Plaguicidas Sintéticos Formulados, Ingrediente Activo Grado Técnico, Coadyuvantes, Vehículos Físicos y Sustancias Afines de Uso Agrícola. Registro" (RTCR 509:2022. Agricultural Inputs. Formulated Synthetic Pesticides, Technical Grade Active Ingredient, Adjuvants, Physical Carriers, and Related Substances for Agricultural Use. Registration), published in the Official Journal La Gaceta No. 253, Alcance No. 278 on December 21, 2022 (https://www.imprentanacional.go.cr/pub/2022/12/21/ALCA278_21_12_2022.pdf ), in which it was ordered to repeal Executive Decree No. 39995-MAG of December 15, 2016, "Reglamento para la actualización de la información de los expedientes de registro de ingrediente activo grado técnico y plaguicidas formulados" (Regulation for the Update of Information of Registration Case Files of Technical Grade Active Ingredient and Formulated Pesticides) and its reform, published in Alcance No 10. of January 16, 2017" (reformed by Decree No. 41481-MAG, the object of this action). Said regulation will come into effect as of March 21, 2023, so the repeal will become effective at that time. Consequently, the constitutionality challenges remain in force.

IV.- ON PHYTOSANITARY PROTECTION, CONSTITUTIONAL FOUNDATION In the first place, it is worth emphasizing that phytosanitary protection measures have a foundation in our Social State of Law, insofar as they seek to simultaneously safeguard values of great constitutional significance: health (Art. 21), the protection of consumer rights specifically to health and the environment (Art. 46), as well as the stimulation of agricultural production, so important for our country, in parallel with environmental protection (Art. 50), and such were the constitutional principles that the legislator took into consideration when promulgating the Ley de Protección Fitosanitaria. This has been recognized by this Court in multiple resolutions. For example, in judgment No. 2009-013606, the Chamber made the following considerations:

"Article 1 of the Ley de Protección Fitosanitaria clearly states: 'Declare of public interest and mandatory application, the phytosanitary protection measures established in this law and its regulations.' Said law addresses principles and needs fundamental for the stability of the country, such as food security and economic activity based on agricultural production. This finds a foundation in several articles of our Political Constitution. Thus, in accordance with Article 50, 'the State shall procure the greatest welfare for all the inhabitants of the country, organizing and stimulating production and the most adequate distribution of wealth'. Furthermore, according to this norm, it must guarantee, defend, and preserve the right of every person to a healthy and ecologically balanced environment, for which the law shall determine the corresponding responsibilities and sanctions. On the other hand, from Article 21 of the Political Constitution, which enshrines the inviolability of human life, the right to health, to the physical, mental, and social well-being of persons, and the obligation of the State to protect them is derived (Constitutional Chamber, Vote No. 3705-93 of 3 p.m. on July 30, 1993). Likewise, Article 46 in fine enshrines the right of all consumers and users to the protection of their health, environment, safety, and economic interests. Such were the constitutional principles that the legislator took into consideration when promulgating the Ley de Protección Fitosanitaria, No. 7664 of April 8, 1997. Among its main objectives are to avoid and prevent the introduction and spread of pests, to protect plants from the damages caused by them, to regulate their combat, to promote integrated pest management within sustainable development programs, to regulate the use and management of chemical, biological, or related substances and of the equipment to apply them in agriculture, as well as to prevent phytosanitary measures from constituting an unnecessary obstacle to international trade (Article 2).

The Law provides a special procedure for the attention of phytosanitary emergencies that may compromise food security and the country's economy, and grants the Administration certain powers to adopt all those measures that allow the control of a situation of that nature. If it is the constitutional duty of the State to organize national production, it is also, consequently, the design of control mechanisms for pests that may negatively affect it, for which various techniques are used such as the declaration of quarantines, the destruction of plants, the control of entry and in the country of origin of plants or biological control agents, integrated pest management, among others. In this sense, the combat of pests must be a shared effort between the State and the private parties involved in a situation of this nature. However, if in the face of a concrete situation the private party does not comply with the guidelines issued by the State Phytosanitary Service for the combat of a pest, the Administration can not only, but is obligated to substitute it and execute the control work that is necessary and that allows the timely containment of the foci of infection that exist. Now, that conduct of the Administration should not generate any patrimonial liability for it, since it is precisely motivated by the private party's omission, who is the first called to combat the infectious situation in accordance with the instructions issued for that purpose by the Phytosanitary Service. This is the reason that justifies the exemption from liability established by the challenged Article 15. The protection of public order is above individual interest, but it is the negligence of the private party that justifies that even though the action of the Administration causes it exceptionally intense damage, there is no legal basis to claim any indemnity from the State, especially if it is considered that this negligence can not only affect it, but may compromise the well-being and general interest of society.

The negligence and omission of the private party then obligate the Administration to deploy its police power in order to protect the social public interest. When we speak of 'police power' in a broad sense, we refer to that set of measures directed at protecting public safety, morality, and salubrity, as well as the defense and promotion of the economic interests of the community and its general welfare. It manifests, in principle, as a power attributed to the legislative power and therefore it is non-delegable. However, the legislator can create in ordinary law an imputation of functions, assigning to the executive power, for example, the attribution to stipulate on certain matters, within the limits pre-established in the law; such is what occurs in the present case. The Ley de Protección Fitosanitaria grants the Executive Branch, through the Ministry of Agriculture and Livestock, the necessary powers to control possible foci of infection and/or pests". (The highlighting does not correspond to the original).

Along these same lines, this Court has been aware that chemical components to contain pests in agricultural products have a clear and notable impact on the environment (the saturation and fertilization of soils), but also on food security (access to foods) and, therefore, it is necessary that the State assume a proactive and vigilant conduct in the matter. Indeed, the State has the obligation to regulate the use of chemical or related substances for agricultural use, so that they are managed correctly, reasonably, and do not generate risks to human health and the environment. Furthermore, it has the responsibility to guarantee the well-being of the inhabitants and an ecologically balanced environment. In judgment No. 2021-019096, the following was resolved:

"VI.- ON THE REGULATION OF THE USE OF PESTICIDES As indicated above, the right to life, to health, and to a healthy environment, are fundamental rights regulated in Articles 21 and 50 of the Political Constitution and their protection is of public interest. Precisely, it is for this reason that the State has the obligation, in the interest of protecting the health of the population, and the environmental precautionary principle, to regulate the use of chemical or related substances for agricultural use, so that they are managed correctly, reasonably, and do not generate risks to human health and the environment. Furthermore, it also has the responsibility to guarantee the well-being of citizens and an ecologically balanced environment. On this issue, the Chamber has established that the State must have a guarantor role with respect to the adequate use of pesticides and the avoidance of their harmful effects on health and the environment. In this sense, in Judgment No. 2004-13968 of 11:35 a.m. on December 3, 2014, it indicated:

"III.- That report [FOE-AM-19/2004 of October 20, 2004, prepared by the Area of agricultural services and environment of the Division of operational and evaluative oversight of the Comptroller General of the Republic, on the evaluation of the State's management in relation to the control of agricultural pesticides] originated from the need to oversee the administrative process related to one of the most pressing environmental problems that the country must resolve, which is the use of chemical, biological, or related substances in agricultural activities, and given the need for the State to intervene, exercising a regulatory function over the use of agrochemicals, that guarantees to farmers the availability in the market of effective products for the combat of pests and, at the same time, the protection of the health of the general citizenry and their right to a healthy and ecologically balanced environment. It was indicated in the report that this control is exercised mainly by the Ministry of Agriculture and Livestock, through the Servicio Fitosanitario del Estado, which must work in coordination with the Ministry of Health and the Ministry of Environment and Energy, regarding control over impacts on health and the environment, as well as with the Ministry of Finance regarding the import and exoneration of such products. Its general objective was to evaluate the State's management in relation to the control of pesticides used in agricultural activities and their effect on the environment and human health, mainly the actions of the Servicio Fitosanitario del Estado of the Ministry of Agriculture and Livestock (MAG); and the specific objectives of the study were: a) to evaluate national policies and governance in the field of control over the use of pesticides, identifying the participating institutions and their competencies, b) to evaluate the process of registering pesticides in the country and the associated regulations, c) to evaluate the process of exoneration and import of pesticides in the country and, d) to evaluate the oversight and monitoring of the use of pesticides.

IV.- In that report, the Comptroller concluded that the Servicio Fitosanitario del Estado (SFE) does not fulfill its creation objectives with efficiency and adherence to the principle of legality, which call it to regulate, execute, and oversee the registration and use of agrochemicals, within the framework of agricultural activity in harmony with nature and with faithful compliance with the constitutional principles of the right to life, to health, and to a healthy environment. It determined that, on the contrary, the actions of said body are oriented towards facilitating the registration and marketing of such substances, justified in a supposed interest in improving the competitiveness of agricultural producers, but rather, those objectives seem directed at fostering competition in the pesticide market, above the constitutional rights of the same farmers and the environmental and health principles of persons. It concluded that the companies most benefited by the facilitation function of the SFE have been the companies dedicated to the sale of agrochemicals, especially those called generics, to the detriment of producers and consumers of agricultural goods. It clarified that this does not mean that pesticides of this type cannot be registered in the country, but rather that their registration must be done respecting the regulations and assuring the Costa Rican population the protection of their health and the fundamental right they have to a healthy and ecologically balanced environment, and protecting the national farmer's right to have good quality inputs; without prejudice to the necessary actions that the State must execute to seek the gradual reduction of the use of pesticides and the promotion of alternative mechanisms.

These considerations prompted the Office of the Comptroller General of the Republic to issue a series of final provisions directed to the President of the Republic and the Ministers of National Planning and Economic Policy, Agriculture and Livestock, Health, Environment and Energy, and Economy, Industry and Commerce, as well as to the Internal Auditor of the Ministry of Agriculture and Livestock.” Similarly, in Judgment No. 2006-09565, issued at 4:08 p.m. on July 5, 2006, this Court held:

“(…) it is evident that the Costa Rican State has the duty to act effectively and in advance to prevent the occurrence of events that degrade the environment and compromise its sustainability.” And, in Judgment No. 2011-016937, issued at 2:36 p.m. on December 7, 2011, it ordered:

“(…) VIII.- ON REGULATION REGARDING PESTICIDE REGISTRATION. The appropriate use of pesticides can be useful for pest control and elimination, benefiting the population’s food security and the economic activity based on agricultural production. However, the potential risk that the use of such substances may pose to human health and the environment must be recognized. This has even prompted the adoption of international instruments with the express objective of protecting human health—including the health of consumers and workers—and the environment from the possible harmful effects of pesticides, as is the case with the Rotterdam Convention on the Prior Informed Consent Procedure for Certain Hazardous Chemicals and Pesticides in International Trade, which was approved by Costa Rica through Law No. 8705 of February 13, 2009.

(…) this Court has recognized the risk that the use of pesticides may entail and the importance of adopting suitable measures to regulate their use. In the Costa Rican legal system, diverse legal and regulatory norms exist from which it derives that the activity of importing, manufacturing, marketing, and using pesticides is strongly subject to the State’s police power to ensure the right to health and a healthy and ecologically balanced environment.” (Considerations that were reiterated in judgment No. 2021-024807).

Echoing these constitutional principles, legislation declared to be of public interest by the legislature has been issued to address this important matter. For example, the aforementioned Plant Protection Law, in Article 1, provides that “the plant protection measures established in this law and its regulations are declared to be of public interest and mandatory application”; the General Health Law (declared of public interest in Article 7) also contains general provisions regarding the management of these substances; and the Law on the Use, Management, and Conservation of Soils (also of public interest pursuant to the express provisions of Articles 3 and 61 of the law) includes provisions and powers in favor of MINAE regarding activities that may cause soil contamination (see Article 28 et seq.).

Thus, a very broad scope of action for the Costa Rican State is observed concerning the use of agrochemicals, which includes regulating both the use and management of chemical, biological, or related substances and equipment for applying them in agriculture, as well as their registration, importation, quality, and waste, while simultaneously seeking to protect human health and the environment.

As it pertains to the object of this unconstitutionality action, the topic of product “registration (inscripción)” is of particular interest, which is regulated in more detail in Articles 23, 24, and 25 of the Plant Protection Law. These establish registration and enrollment (registro e inscripción) as one of the control mechanisms for establishments and inputs for agricultural use. Specifically, and of particular relevance to this unconstitutionality action, Article 23 of the law states the following:

“Article 23 - Registration of Substances and Equipment According to the requirements set forth in the regulation of this law, all chemical, biological, or related substances and application equipment for agricultural use must be registered in the registry (registro) that the State Plant Health Service will create to have information on the characteristics of these and to ensure their correct use in the country.” As will be examined below, the regulations subject to this action respond precisely to this State obligation, entrusted to the SFE, to keep the registry of substances used for agricultural purposes updated.

V.- PRECEDENTS IN THE CONSTITUTIONAL JURISDICTION The matter under analysis has been examined from different angles by this Court.

In judgment No. 2017-06668, regarding the constitutionality of Executive Decree No. 39995-MAG (which was later amended by the decree subject to this action), the following was resolved:

“ON THE MERITS. REGARDING THE ALLEGED VIOLATION OF THE RIGHT PROTECTED IN ARTICLE 50 OF THE POLITICAL CONSTITUTION, RELATING TO A HEALTHY AND ECOLOGICALLY BALANCED ENVIRONMENT. The plaintiff accuses a violation of the right protected in Article 50 of the Political Constitution, specifically, of the precautionary principle and the principle of reversing the burden of proof in environmental matters, given that, on one hand, the discussed regulations require the Administration to demonstrate the existence of an unacceptable risk to human health, the environment, or agriculture for the registration of an active ingredient and formulated pesticides to be restricted or prohibited, despite the scope of the aforementioned principle, and, on the other hand, the fact that, according to the challenged regulations, it is the Administration's responsibility, not the activity operator's, to prove the existence of a risk to the mentioned legal interests, when the principle in question demands the opposite. In this regard, Article 7 of Executive Decree No. 39995-MAG, Regulation for Updating Information in the Registration Files for Technical Grade Active Ingredient and Formulated Pesticides (which is, in substance, what the plaintiff challenges), stipulates the following:

“ARTICLE 7. During the validity period of a registration, when the competent Ministries demonstrate an unacceptable risk to human health, the environment, or agriculture, the State Plant Health Service shall restrict or prohibit its use.” The norm, per se, aims to protect the environment and human health, as it precisely seeks to restrict or prohibit the use of a valid registration when an unacceptable risk exists; consequently, far from harming these constitutional interests, it protects them. The appropriate moment to apply the precautionary principle is when an active ingredient or pesticide is to be registered. It is to be supposed that during this registration enrollment (inscripción de un registro) procedure, the circumstance may arise that there is some technical or scientific doubt about the product's impact on human health, the environment, or agriculture. It is at that procedural stage that the precautionary principle can be applied, i.e., when in doubt, the administration must decide not to register it. The challenged regulatory norm, that is, Article 7, refers to a stage subsequent to this, as it assumes that the enrollment procedure (procedimiento de inscripción) has already been processed, concluded, and the registration already exists. Consequently, to invalidate a previously processed registration, the demonstration of an unacceptable risk is indeed required. On the other hand, as already indicated, the norm is protective of human health and the environment, for which it contemplates a sovereign power of the public administration, such as the restriction or prohibition of the use of a registration, even if a prior substantial legal situation exists in favor of the administered party, such as the registration.

IV.- ON THE VIOLATION OF THE PROVISIONS OF ARTICLE 146 OF THE POLITICAL CONSTITUTION. The Constitutional Chamber does not consider that the omission of the Minister of Health and the Minister of the Environment to sign the Decree constitutes a defect of unconstitutionality in the challenged regulations, considering that, as the plaintiff acknowledges, the challenged Decree has been issued jointly by the President of the Republic and the Minister of Agriculture, whereby no infringement of the provisions of Article 146 of the Political Constitution is observed, despite the plaintiff's claims in this regard. By virtue of the foregoing, the action must also be dismissed on the merits concerning this point.” (Emphasis not in the original).

These considerations are especially significant for the specific case, as they make it clear that for an already authorized registration to be rendered ineffective, the demonstration of an unacceptable risk to human health and the environment must be justified. Likewise, it was emphasized that the omission of the Minister of Health and the Minister of Environment to sign the decree does not constitute a defect of unconstitutionality in the challenged regulations.

Subsequently, in judgment No. 2017-007766, the following was resolved:

III.- SPECIFIC CASE. Before resolving this amparo appeal, it must be noted that the purpose of the amparo appeal is to provide timely protection against infringements or threats to fundamental rights and freedoms, not to serve as a generic instrument to guarantee the principle of constitutional supremacy or the principle of legality. For that reason, the Chamber cannot set itself up, through this means, as an abstract controller of the constitutionality of infra-constitutional norms. Hence, pursuant to subsection a) of numeral 30 of the Law governing this jurisdiction, the amparo appeal does not proceed in this case against laws or other normative provisions, except when they are challenged jointly with acts of individual application thereof, or when dealing with norms of automatic application, in which case the procedure regulated in numerals 73 et seq. of the Law of Constitutional Jurisdiction must be followed. According to the assumptions just mentioned, the amparo does not proceed in this case.

IV.- NOTE OF JUDGES CRUZ CASTRO AND RUEDA LEAL. Through resolution No. 2017006668, issued at 10:50 a.m. on May 10, 2017, an unconstitutionality action against Executive Decree No. 39995-MAG, Regulation for Updating Information in the Registration Files for Technical Grade Active Ingredient and Formulated Pesticides, was dismissed on the merits. In said judgment, Judges Cruz Castro and Rueda Leal dissented and ordered that the action be processed, because we considered that the matter merited elucidation through the unconstitutionality action procedure.

V.- SEPARATE NOTE OF JUDGE HERNÁNDEZ LÓPEZ. I concur with the majority vote in this amparo appeal; however, I must expressly state that my position was to process the action brought at the time by the interested parties in relation to this topic. My reasons were as follows:

“From my perspective, the decree establishes procedures to bring a group of pesticide registrations up to date with current technical requirements and assures those who manage to meet such conditions not only a new authorization period (Article 6), but also the guarantee (Article 7) that State authorities will not hinder their business unless they can demonstrate “an unacceptable risk to human health, the environment, or agriculture.” Read in this way (as proposed by the plaintiff), the norm seeks to provide registration holders with a guarantee against State actions regarding their products, but at the cost—according to the appellant—of sacrificing the precautionary principle, which holds constitutional rank.

I consider that the Costa Rican legal system constitutionally and conventionally obligates the State to protect public health, in such a way that if a person reasonably proves a certain, real, and imminent risk to public health from the effects of a registered pesticide, State authorities have the duty to act, regardless of whether that product is registered or not, because such registration could not be placed above a legal interest such as public health. History documents numerous examples of pesticides such as Nemagon or DDT, which, despite having passed the tests and filters existing at the time to guarantee their viability, turned out not to be harmless to human health.

The challenged norm is embedded within a regulatory framework of protection at the constitutional and conventional level that obligates the authorities—even ex officio—to dictate the precautionary measures they deem necessary when a certain, real, and imminent injury to the health of the inhabitants is reasonably established, in such a way that the phrase “unacceptable risk” is not one that the administration must conclusively prove, nor that imposes the burden of proof on the administered party, but rather one that—as indicated above—is reasonably proven from concrete facts, a protection for which the legal system provides, among other legal instruments, protection through the amparo appeal.

Similarly, regarding the precautionary principle in environmental matters, this Constitutional Court has taken important steps, as seen, for example, in the doctrine that can be extracted from Judgment No. 2004-1923, issued at 2:55 p.m. on February 25, 2004, which broadly develops the postulate that absolute scientific certainty should not be used as a reason to postpone the adoption of cost-effective measures to prevent the degradation of the environment (…)

The transcribed judgment is binding for State authorities, such that both the right to health and the precautionary principle in environmental matters obligate the State to act even in the face of mere risk, provided, of course, that it is certain, real, and imminent, whereby the discussed norm could not override—and, from my perspective, it does not—the State's obligation to act to protect these legal interests, an action that is supported by constitutional and conventional norms. In that sense, I do not believe the norm itself has wording that clashes with the indicated values; however, if its application were to occur in a framework that threatens the indicated interests, the legal system has—above said norm of merely regulatory value—the immediate precautionary remedies that the administered party can request for their protection, among them, the amparo appeal.

Consequently, for the stated reasons, I consider that the norm, in its content, can never, per se, override the constitutional and conventional obligation that the State has to protect health and the environment.” Thus, I clarify my position in that case and the reasons why I now agree with the majority.” Furthermore, the Chamber addressed the constitutionality of Decree No. 40059-MAG-MINAE-S, “RTCR 484:2016. Agricultural Inputs, Formulated Synthetic Pesticides, Technical Grade Active Ingredient, Adjuvants, and Related Substances for Agricultural Use. Registration, Use, and Control,” whose purpose was to regulate the registration process for formulated synthetic pesticides, technical grade active ingredient, adjuvants, and related substances for agricultural use by the SFE. Its scope of application consists of natural or legal persons who register, market, import, formulate, manufacture, repack, refill, store, distribute, and handle formulated chemical pesticides, technical grade active ingredient, adjuvants, related substances, as well as those of mineral origin and inorganic salts. Through vote No. 2022-023238, the majority dismissed the unconstitutionality action. From the foregoing, it is observed that said regulation was applicable for new enrollment processes (procesos de inscripción).

On the other hand, in vote No. 2022-026651, this court addressed the constitutionality of Decree No. 39995-MAG, titled “Regulation for Updating Information in the Registration Files for Technical Grade Active Ingredient and Formulated Pesticides,” and, by majority, the unconstitutionality action was dismissed. Said decree and the one being examined in the case file do not specifically refer to an enrollment or registration process (proceso de inscripción o registro) for new pesticides, but rather their regulation is applicable to products already on the market, but whose registration was carried out under other parameters where prior IAGT registration was not required. Therefore, the Executive Branch deemed it essential to update the information of these registrations and also to establish a validity period equal to that of registrations granted under current regulations. Precisely in said constitutionality process, it was explained that Decree No. 39995-MAG of December 15, 2016, is a regulation designed for updating information in the registration files for technical grade active ingredient (IAGT) and formulated pesticides. The regulation seeks to comply with the registration of all chemical, biological, or related substances for agricultural use, of long-standing use in the SFE registry. This includes all those chemical entities not registered because the legislation did not establish it as a mandatory requirement. Thus, under this Regulation, no IAGT and/or formulated product marketed in Costa Rica should be unknown to the State, and, better still, said regulation seeks to have updated information that allows better control. It thereby brings the technical and scientific information of old registrations to the present by associating the IAGTs with those registered under the regulations under which they were enrolled (inscribió). In this way, it opens the possibility for the State to possess the confidential chemical information lacking in the files of old registrations. Based on these premises, the grievances regarding constitutionality formulated in the specific case will be examined next.

VI.- ON LEGAL POWERS First, the plaintiff states that the Ministry of Health and MINAE must actively participate in this process of registration, post-registration, and revalidation or updating of pesticide information, as the substances have a direct or indirect impact on the environment in general and, consequently, on human health. They therefore question that the decree grants the SFE the power to unilaterally grant registration, without the participation of the other ministries, which in their view implies a setback in the level of protection and a violation of the principle of objectification of environmental protection.

The Minister of Agriculture and Livestock explained, in this regard, that the legal and technical norms relating to plant protection must be interpreted in accordance with the constitutional duty of the State and society in general to act in prevention of environmental risk and health, both human and animal, as is indeed done when issuing both Executive Decree No. 39995-MAG and No. 41481-MAG. He indicated that the legislature conferred upon the SFE the competence to achieve the purposes contained in the Plant Protection Law and that this allocation of competence is exclusive to said body, within which the creation and custody of the respective registries are included. To this effect, the provisions of the Plant Health Law and the Plant Protection Law are cited. The latter expressly establishes the competence in matters of registration and oversight of agricultural pesticides with the SFE.

On this point, the PGR stated that the challenged decree does not include the participation of the Ministry of Health and MINAE, and, therefore, carries the same defect as Decree 39995, unless the Chamber considers that the powers attributed to other bodies in their respective creating laws are not repealed or modified by the challenged norm, and that the SFE—within the exercise of its legal powers—can and must request the participation of any specialized technical body to verify that a pesticide does not threaten health and the environment.

In this regard, the Chamber does not observe that this specifically constitutes an injury to the Right of the Constitution. The fact that the ordinary legislature decided to concentrate plant protection powers in a specific authority of legal creation, such as the SFE, attached to the MAG, does not in any way imply an injury to any provision of our Political Constitution. It corresponds to a specific organic and competency design decision that is freely configurable by the legislature and which, moreover, does not invalidate the stewardship that the Ministry of Health or MINAE may have in matters within their own sphere of competence. In this regard, the legislature provided broad powers in favor of the SFE specifically regarding plant protection. To this effect, Article 5 of the Plant Protection Law, No. 7664, establishes the following:

“ARTICLE 5.- Functions and Obligations The State Plant Health Service shall have the following functions:

• a)Ensure the sanitary protection of plants.
• b)Advise on plant protection matters and recommend the issuance of the necessary legal norms in this field.
• c)Coordinate with other ministries and their dependencies the pertinent actions for compliance with this Law and its Regulations. It shall be an auxiliary and assisting body to the General Directorate of Customs of the Ministry of Finance in the oversight and control of the entry and values of merchandise or products of an agricultural nature.

(As amended by Article 3 of Law No. 8373 of August 18, 2004).

• d)Develop, recommend, coordinate, execute, and disseminate the regulations and provisions that guarantee the application of this law.
• e)Order and execute the technical, legal, and administrative measures to avoid, prevent, and delay the introduction or establishment of new pests in plants.
• f)Eradicate, control, or slow the spread of already introduced pests.
• g)Carry out plant health control of the national and international exchange of plants, biological control agents, and other types of organisms used in agriculture, packaging and conditioning materials, and means of transport capable of spreading or introducing pests that threaten food security and the economic activity on which agricultural production is based.
• h)Formulate, execute, and supervise pest survey and detection programs, as well as emergency plans.
• i)Study and diagnose the plant health status of the country.
• j)Establish and keep updated a national information system regarding plant health status.
• k)Officially declare the presence of pests and their quarantine importance.
• l)Evaluate and regulate, in the area of plant protection, any production method.
• m)Organize, endorse or not endorse, and support the development, dissemination, and application of programs for the prevention and control of existing pests.
• n)Promote and control integrated pest management and the appropriate methodologies used.
• ñ)Control the plant health quality of propagation material.
• o)Control chemical, biological, or related substances for agricultural use, concerning their registration (inscripción), import, export, quality, tolerance, residues, dosages, effectiveness, toxicity, presentation to the public, conservation, management, trade, general conditions of use, safety and precautions in transport, storage, disposal of containers and waste of such substances; likewise, control the equipment necessary to apply them and any other activity inherent to this matter.
• p)Control the plant health quality of export plants to issue phytosanitary certificates, in accordance with international treaties in force on the matter, this law, and its regulations.
• q)Regulate, in the area of plant protection, the import, export, research, experimentation, movement, multiplication, industrial production, marketing, and use of transgenic materials and other genetically modified organisms for agricultural use or their products.
• r)Promote, support, and endorse the required plant health scientific research.
• s)Manage technical and financial support from national and international bodies to strengthen the State Plant Health Service.
• t)Recommend to the Executive Branch the ad honorem appointment of plant health authorities.
• u)Ensure the administration, control, and use of resources obtained through the application of this law.
• v)Provide, under prior agreement, training, advice, and consultancy in plant protection matters.
• x)Promote the international harmonization of plant health measures.

The controls mentioned in this article may be carried out in a total or random manner, as established through technical criteria.” (Emphasis not in the original).

From the above, it follows that the competence to “control chemical, biological, or related substances for agricultural use, concerning their registration (inscripción)” was expressly assigned by the legislature to the SFE, without prejudice—as provided in the same article—to coordinating with other ministries and their dependencies the pertinent actions for compliance with this law and its regulations.

Furthermore, the law expressly establishes that substances must be registered in the registry that the SFE is precisely responsible for creating and keeping, and also provides the consequences for failing to comply with the procedure:

“Art. 23. Registration of Substances and Equipment.

According to the requirements set forth in the regulation of this law, all chemical, biological, or related substances and application equipment for agricultural use must be registered in the registry that the State Plant Health Service will create to have information on the characteristics of these and to ensure their correct use in the country.

Art. 24.- Registry of Substances No natural or legal person may import, export, manufacture, formulate, store, distribute, transport, repack, refill, advertise, handle, mix, sell, or use chemical, biological, or related substances for agricultural use that are not registered in accordance with this law. (…)” It is required, of course, that these powers must be exercised within the framework of the constitutional rights to health and a healthy environment, and that the SFE authorities must in all cases safeguard such rights.

In this regard, it is necessary to emphasize that this Court, in Judgment No. 2022-023238, already established that, despite the registrations being under the SFE's competence, the other mentioned ministries have the possibility to warn, within their area of competence, of the existence of prohibited materials or those subject to new restrictions in accordance with international regulations falling under such competences. It was noted that this type of regulation does not imply that the other functions of the two ministries are diminished and that they cannot exercise active participation and collaboration, prior to the granting of registration or in the surveillance function, when a registration fails to comply with international obligations due to the use of internationally prohibited products; for example, international standards of unacceptable risks to health and the environment (see Judgment No. 2022-023238). Indeed, in the report rendered in case file No. 18-009107-0007-CO, the PGR stated the following:

“[T]he possible flexibilization of the pesticide registration procedure made by Decree No. 40059-MAG-MINAE-S in an effort to give the agricultural sector greater access to lower-cost products or inputs cannot be to the detriment of the legal competence of the technical bodies of MAG, MINAE, and MINSA to request the information they deem pertinent and determine, through rigorous evaluations and data analysis, that the requested agrochemicals are harmless to human health and the environment.” (Emphasis not in the original).

Moreover, it should be noted that the criticisms made by the plaintiff—in light of the CGR's considerations—had a different regulatory context, as it was precisely in response to said recommendations and omissions that a transitional measure was expressly adopted in Executive Decree No. 40059 “Technical Regulation: “RTCR 484:2016. Agricultural Inputs. Formulated Synthetic Pesticides, Technical Grade Active Ingredient, Adjuvants, and Related Substances for Agricultural Use.” Registration, Use and Control,” effective as of July 13, 2017, which precisely aims to provide the MAG and the SFE with suitable technical bodies to resolve all matters related to the registrations of agrochemicals and expressly establishes that said body must operate “without prejudice to the constitutional or legal powers corresponding to the Ministries of Health or Environment”:

“FIFTH TRANSITIONAL PROVISION: The Ministry of Agriculture and Livestock shall establish within its structure, within a period of twelve months from the effective date of this decree, the Evaluation Areas: chemical, agronomic, toxicological, and ecotoxicological, as part of the Agrochemical and Application Equipment Registration Unit, and which shall be responsible for the review, verification of compliance with requirements, evaluation, and qualification of toxicological and ecotoxicological documents and studies and environmental fate studies, as established by this regulation in the different registration modalities, without prejudice to the constitutional or legal powers corresponding to the Ministries of Health or Environment.” (Emphasis not in original).

Consequently, it is incumbent upon the national technical authorities, in accordance with the broad powers granted by the legal system, to carry out the procedure for updating the information in the registration dossiers for technical grade active ingredient and formulated pesticides with the utmost rigor and care in order to safeguard the fundamental rights to health and a healthy environment of all inhabitants. Thus, the ultimate responsibility for the decision on whether or not to authorize the product update request lies with the national authorities. In this regard, judgment No. 2022-023238 concluded that in each specific petition—in the specific case, it refers to updating the information in the registration dossiers for technical grade active ingredient and formulated pesticides—it is the duty of our national authorities to be vigilant regarding the studies submitted to them for assessment, and it does not imply, in any way, an authorization for them to relax in the procedure and vigilance that must be carried out.

On this point, it should be added that even if we had the highest regulatory standards, that in itself would not be sufficient if the national authorities do not responsibly exercise the powers that concern them. In that sense, a dismissal of the grievance does not imply that it is endorsing that the authorities are not vigilant ex ante and ex post. On the contrary, this Chamber understands that, even at the slightest trace of doubt, they must proceed to request all pertinent documentation or studies, with the purpose of verifying that the product whose registration is to be updated complies with the parameters and conditions necessary to safeguard human health. Likewise, it is their duty to ensure that its use is appropriate and has the desired effects. The rigor in the selection of studies is just as important as the subsequent controls that can be carried out in the application and use of the products.

It is timely to cite the reflections made by this Chamber in judgment No. 2011-016937, regarding other regulations aimed at the registration of pesticides:

“VII.- ON THE REDUCTION OF RISKS TO HEALTH AND THE ENVIRONMENT, PURSUANT TO ARTICLE 5 OF THE INTERNATIONAL CODE OF CONDUCT ON THE DISTRIBUTION AND USE OF PESTICIDES. It is of interest to refer to the provisions of the aforementioned International Code of Conduct on the Distribution and Use of Pesticides, which was adopted, for the first time in 1985, by the twenty-fifth session of the conference of the Food and Agriculture Organization of the United Nations (FAO). As explained in the preface of the revised version (adopted by the 123rd session of the FAO Council, November 2002), said code of conduct was adopted and has been revised with the purpose of achieving greater food security and, at the same time, protecting human health and the environment. For these purposes, standards of conduct are established that shall serve as a framework and point of reference for the proper and rational use of pesticides, focusing on risk reduction, the protection of human and environmental health, and support for the development of sustainable agriculture through the effective use of pesticides [source: (Source: http://www.fao.org/agriculture/crops/core-themes/theme/pests/pm/code/en/(05/08/11)] (…)

VIII.- ON REGULATION REGARDING THE REGISTRATION OF PESTICIDES. The proper use of pesticides can be useful for the control and elimination of pests, for the benefit of the population's food security and the economic activity based on agricultural production. However, the potential risk that the use of such substances may pose to human health and the environment must be recognized. This has even motivated the adoption of international instruments with the express objective of protecting human health—including the health of consumers and workers—and the environment from the possible harmful effects of pesticides, as is the case of the Rotterdam Convention on the Prior Informed Consent Procedure for Certain Hazardous Chemicals and Pesticides in International Trade, which was approved by Costa Rica, through Law No. 8705 of February 13, 2009. In which case, regarding the mandatory legislative consultation of constitutionality raised before this Tribunal (file number 08-015252-0007-CO), prior to the approval of said international instrument, this Tribunal indicated—to the extent relevant—that:

“(…) the Costa Rican State has the duty to act effectively and proactively to prevent the occurrence of events that degrade the environment and compromise its sustainability. From that perspective, committing, through an international treaty such as the one consulted, or through an internal act, to facilitate the rational use of chemically hazardous products subject to international trade is not only possible but entirely consistent with its constitutional duties. Pesticides and industrial chemical products are substances that can cause damage to human health and the environment. Faced with such a threat, the Rotterdam Convention provides the Parties with the possibility of knowing in advance the composition and effects of certain chemical products, which are expressly indicated in its Annex III. The suitable measures that the State takes to regulate the commercialization and use of said products in industrial, agricultural, etc. activities are in accordance with its duty to preserve the aforementioned values of constitutional rank. Hence, the duties that the State would assume should it definitively approve this Convention are legitimate, in accordance with the Law of the Constitution. It would be a sovereign decision of the State to submit to the obligations contained in the Convention, to contribute to the protection of people's health and the integrity of the environment, for which it can be concluded that, in general terms, from the clauses of the Rotterdam Convention, whose approval is submitted for consultation, no defects of unconstitutionality are observed.” (Resolution number 2008-018207 of 6:15 p.m. on December 10, 2008) Thus, it is verified that this Tribunal has recognized the risk that the use of pesticides may entail and the importance of adopting suitable measures to regulate their use. In the Costa Rican legal system, there is diverse legal and regulatory legislation from which it is derived that the activity of importing, manufacturing, commercializing, and using pesticides is strongly subjected to the police power of the State, in the interest of guaranteeing the right to health and a healthy and ecologically balanced environment. First, the General Health Law can be cited, which in its article 213 provides:

“ARTICLE 213.- Every person, natural or juridical, engaged in producing food must do so under sanitary environmental conditions and using defense or conservation techniques approved by the health authority, in order to prevent, principally, the contamination of such products and their danger due to the presence of toxic residues from their treatment with pesticides or other defense or conservation systems.” Meanwhile, article 244 of that same regulatory body establishes:

“ARTICLE 244.- Natural and juridical persons that import, manufacture, handle, store, transport, trade, supply, or apply substances, mixtures of substances, or products called pesticides by the plant health law shall be subject to the regulatory provisions that the Ministry dictates by mutual agreement with the Ministry of Agriculture for the protection of people's health in accordance with that law; interested parties must register every pesticide or product intended for the control or extermination of infestations and request prior permission to operate when such substances, mixtures of substances, or products that, due to their nature or use, are not included in the aforementioned law are capable in some way of causing poisoning or serious harm to the health of people or useful or harmless animals to man.” For its part, through the Phytosanitary Protection Law (Law No. 7664 of April 8, 1997), the phytosanitary protection measures established in that law and its regulations were declared of public interest and mandatory application (art. 1). Furthermore, within the objectives of said law is included: “Regulate the use and handling of chemical, biological, or related substances and equipment to apply them in agriculture; likewise, their registration, importation, quality, and residues, while simultaneously seeking to protect human health and the environment” (Article 2, subsection e). The competent authority on the matter is the State Phytosanitary Service, which is responsible for—among other functions—: “Controlling chemical, biological, or related substances for agricultural use, regarding their registration, importation, exportation, quality, tolerance, residues, dosages, effectiveness, toxicity, presentation to the public, conservation, handling, trade, general conditions of use, safety, and precautions in transport, storage, disposal of containers and waste of such substances; likewise, control the equipment necessary to apply them and any other activity inherent to this matter” (Article 5, subsection o). (…) It follows from the previously cited regulations that, as a manifestation of the aforementioned police power, the necessary registration of pesticides prior to authorizing their importation, manufacture, commercialization, or use is included, in order to exercise prior control regarding the due compliance with the corresponding technical quality and safety requirements, in protection of public health and the environment.” Such considerations are applicable in the sub lite, that is, that the domestic legal system contemplates various regulations and powers in favor of the national technical authorities so that, in use of that police power, they remain vigilant and guarantee the quality and benefit of the pesticide products whose registrations are intended to be updated and, ultimately, that the rights of all persons are thus safeguarded.

In this regard, as will be seen below in detail, the challenged regulation is not designed for the registration of new pesticide products, but to update the registrations of products that are already registered and freely marketed in the national market. In the face of the slightest doubt that the duly registered pesticide (whether as IAGT or formulated pesticide) causes harm or a threat to health or the environment, all national authorities, including the Ministry of Health or MINAE, have their own attributions and powers to institute the corresponding procedures in order to prevent the importation, manufacturing, handling, commercialization, or use of the product. Moreover, if necessary, they can issue the precautionary measures that are necessary to safeguard the legal interests mentioned. Precisely, the precautionary principle—which is invoked by the claimant—must inspire all ex ante and ex post control conducts of all the public authorities mentioned and, if in any specific case harm or threats to public health or the environment are suspected or there is evidence thereof, they have the constitutional obligation to adopt the corresponding preventive measures.

Echo must be made of what was already indicated in judgment No. 2017-06668, regarding the constitutionality of Executive Decree No. 39995-MAG, and which is also applicable to this decree, since the fact that the Ministers of Health and Environment and Energy did not sign the decree does not imply a defect of unconstitutionality in the regulation questioned because it was issued jointly by the President of the Republic and the Minister of Agriculture, and thus, no violation of the provisions of Art. 146 of the Political Constitution is observed.

Finally, it is reiterated that, in light of the provisions of Art. 10 of the General Law of Public Administration (LGAP)—the administrative norm must be interpreted in the manner that best guarantees the realization of the public purpose to which it is directed—, this special regulation must be applied and interpreted integrally with the provisions of the legal system on the matter (public interest laws mentioned supra). That is to say, in no way can it be understood that the challenged regulation constitutes an isolated regulatory body from the rest of the block of legality and constitutionality, and that the specific task of updating the information of the registrations implies nullifying the rest of the legal powers entrusted to other ministerial departments.

By virtue of the foregoing, and based on the considerations made, this Chamber is unable to substantiate the alleged violations of the precautionary principle attributed to the decree, merely because it was signed by the MAG and because the registration update powers are concentrated in the SFE. As examined, such powers are powers of authority granted by the legislator itself (Art. 59 LGAP) that do not render ineffective the other legal provisions of public interest on the matter.

VII.- ON THE PROCEDURE REGULATED BY THE CHALLENGED REGULATION The claimant insists that the Ministry of Health and MINAE must intervene in these processes, even more so when in this case it is not a simple update, but rather a scientific analysis of the information presented by the registrant to carry out the respective risk assessment.

At this point, the Minister of Agriculture and Livestock explains that the decree for updating dossiers and its amendment applies exclusively to all registrations of “technical grade active ingredient” (IAGT) and formulated products that were registered under a different (legal or regulatory) regulation than Executive Decree No. 33495-MAG-S-MEIC-MINAET, “Regulation on the Registration, Use and Control of Formulated Synthetic Pesticides, Technical Grade Active Ingredient, Co-adjuvants and Related Substances for Agricultural Use.” That is, he emphasizes that it only applies to those registration dossiers for products that are already on the market and that were registered in accordance with the regulations applicable at the time of their approval and that were integrally evaluated (health, environment, and biological efficacy) in accordance with that regulation. He argues that the claimant confuses and intends to confuse regarding the registered agrochemicals that are currently commercialized in the country, which are those to which Executive Decree No. 39995-MAG and No. 41481-MAG apply, trying to make it seem that they must be evaluated again, which is neither procedurally correct nor necessary, since all products registered in Costa Rica complied with the requirements and regulations established in the positive law in force at the time those registrations were granted. Consequently, he vehemently clarifies that for none of the pesticide products, be they raw materials or formulated products that have a valid registration, is there evidence or technical scientific presumption, or at least indications, that presume an additional or resulting danger from its application, regarding human health, the environment, or the biological efficacy of the pesticide. Both the Constitutional Chamber and the PGR have been clear in the sense that the Ministry of Health, the Ministry of Environment, the Ministry of Agriculture, or even private parties can go to the ordinary jurisdictional venue to request the annulment of the administrative acts through which those registrations were granted, and can even request that their commercialization be precautionarily suspended. However, neither the Ministry of Health, nor the Ministry of Environment, nor the claimant does so because they lack evidence and scientific and technical support to do so, and, therefore, he understands that the claimant recklessly comes to the Constitutional Chamber to raise matters of legality through unconstitutionality actions, whose sole purpose and objective is to hinder the process of organizing the agrochemical registry system undertaken by the Administration.

He insists that with the aforementioned decrees—No. 39995-MAG and No. 41481-MAG—registrations of IAGT or for new formulated pesticides are not being granted, but rather it only applies to old IAGT (raw materials) and formulated products. In this regard, he explains that it was from 2007 onward that a registration system was established requiring the prior registration of the raw material—IAGT. Before that date, it was not necessary to register the IAGT, and that is why the Executive Branch issued the decrees under challenge. He alleges that it is not as the claimant indicates, that through the challenged regulations the registration of new products is being facilitated, since the truth is that nothing is facilitated, but rather a space is opened for registration holders to submit confidential chemical information, which is fundamental to guarantee that there are no relevant impurities from a toxicological and ecotoxicological point of view in any of the products currently commercialized in the market under a valid registration, granted for an indefinite term. Therefore, he maintains that it is not correct to assert that with the application of these regulations the registrations whose dossiers are updated pose an additional risk to health, the environment, or agriculture, since all the IAGT registrations granted must necessarily and inevitably correspond to one of the formulations already sold on the market, and on these formulations the Ministries of Health or Environment have broad and indisputable powers and faculties to adopt the pertinent measures in order to prevent harm to health or the environment.

He points out that Executive Decree No. 39995-MAG and its amendment No. 41481-MAG make it possible to resolve the problems of disorder, uncertainty, and lack of information in the registration dossiers that support the registrations of IAGT and formulated pesticides with a valid registration, but that were granted under a regulation different from Executive Decree No. 33495-MAG-S-MINAE-MEIC. He considers that the questioned regulation is a major step forward and resolves a problem that began in 2004 and had not yet been resolved by previous administrations, as it provides alternatives and pathways to resolve the two most serious problems afflicting the registration system of our country: on the one hand, the paralysis in the registration of new and generic products, and, on the other, the impossibility of renewing registrations for formulations that are currently on the market.

In that sense, he details that the challenged regulation allows: a) the updating of manufacturers, their origin, production sites of the IAGT associated with the formulations already commercialized in Costa Rica and that were registered under different legislation; b) the same in relation to formulated pesticides; c) to end the legal uncertainty regarding the validity of the IAGT and formulated pesticide registrations that were registered under previous legislation and regulation, standardizing the validity period of ten years for all registrations and thereby eliminating the indefinite validity. He explains, consequently, that the registration dossier required in Art. 23 of the Phytosanitary Protection Law is provided with all the chemical information required to make decisions regarding the product in terms of its safety and efficacy and putting a stop to indefinite-term registrations.

During the processing of the amparo appeal No. 17-002503-0007-CO, the then Minister of MAG informed, under the gravity of an oath, before this Chamber, the following:

“regarding the basis that gives rise to the promulgation of Executive Decree No. 39995-MAG, we find it in the 7 recitals, of which the first 6 provide the legal basis, in this case the Phytosanitary Protection Law No. 7664, whose purpose is to regulate the use and handling of chemical, biological, or related substances and equipment to apply them in agriculture; likewise, their registration, importation, quality, and residues, while simultaneously seeking to protect human health and the environment, all of which must be inscribed in the registry that the State Phytosanitary Service shall create to have information on the characteristics of these substances and ensure their correct use in the country. Agricultural pesticides are fundamental for combating pests that affect agricultural production and for the competitiveness of agricultural producers, therefore it is essential to guarantee the supply and continuity in the commercialization of products that currently have a valid registration, making it necessary to update the information in their dossiers on their characteristics and ensure their correct use in the country. It is precisely this recital that summarizes the purpose of the decree under analysis. The decree indicates in its recital 4 that the regulations prior to the effective date of Executive Decree No. 33495 MAG-S-MENAE-ME1C of October 31, 2006, and its amendments, allowed the Ministry of Agriculture and Livestock to grant registrations for an indefinite term as well as the registration of formulated pesticides without it being a requirement to have prior registration of the technical grade active ingredient (IAGT), which obliges, within the constitutional and legal powers of the Executive Branch, to organize its registry, ordering the updating of the information of registrations inscribed without a term having been granted under a regulation prior to that which governs the current registration. The appealed decree aims to update the dossiers with the information that was not requested at the time of their registration and to have updated information, through a re-registration process in accordance with Constitutional Article 50, such that the State shall seek the greatest well-being for all the inhabitants of the country, organizing and stimulating production and the most adequate distribution of wealth, guaranteeing a healthy and ecologically balanced environment. The State shall guarantee, defend, and preserve that right, which is guaranteed by the decree since, although production is stimulated, that does not preclude protecting the environment and health and life, none of which can be put at risk, which is why the Ministry of Agriculture and Livestock has the legal power to administer the registry assigned to it by law and for which, at a minimum, it must update the dossiers as part of its internal organization. Registrations granted prior to Executive Decree No. 33495-MAGS-MINAE-MEIC of October 31, 2006, and its amendments were granted without a term, which obliges the Executive Branch to an analysis of those registrations, requesting from each registrant the information established in the Decree we are dealing with in order to update the registration and therefore the information, so that registrants can register in accordance with the requirements of current regulations, while guaranteeing the continuity of their commercialization, given their importance as a tool for combating agricultural pests and also stimulating the production entrusted by law to the Ministry of Agriculture and Livestock, without detriment to the other constitutional guarantees such as life and a healthy environment, provided that production is not harmed, insofar as it does not affect life. Due to the nature of the regulation issued, this is not a Technical Regulation but an update of valid registrations, so the technical regulation procedure is not required; however, the regulation was uploaded to the MEIC website, as stated in the attached administrative dossier, filling out the Form for Cost-Benefit Evaluation in Section 1, called Prior Control of Regulatory Improvement, and it yielded a negative result and was available to citizens as it was a freely accessible page. The decree, in summary, provides that the holders of registrations for Technical Grade Active Ingredients (IAGT) and formulated products that do not have an IAGT registration and that were not registered in accordance with Executive Decree No. 33495-MAG-S-MINAE-MEIC of October 31, 2006, and its amendments, must update the manufacturer or manufacturers of their IAGTs within a period of twenty-four months from the entry into force of this decree; providing the State Phytosanitary Service the information indicated there for the manufacturer update, further referring to the provisions of the Central American Technical Regulation No. RTCA 65.05.67.13: Agricultural Inputs. Technical Grade Active Ingredient, Formulated Chemical Pesticides, Related Substances, Co-adjuvants, and Physical Vehicles for Agricultural Use. Requirements for the Preparation of Labels and Leaflets. Resolution No. 365-2015 (COMIECO LXXII). For formulated pesticides whose IAGT is not registered, and whose dossier has been updated, the State Phytosanitary Service shall grant, within a period not exceeding three months, counted from the date on which the update was approved, the corresponding IAGT registration. The decree expressly establishes that the IAGT registrations granted under the decree may not be used as a reference profile under the equivalence registration modality, unless the complete data has been provided. Article 7 refers to the legal powers that different laws grant to the Ministry of Health and the Ministry of Environment, not to the administration of the registry which is what the regulation seeks, since the power of the Ministries of Health, Environment, and Agriculture to restrict or prohibit the use of a pesticide is independent of the reference decree. Based on the report rendered and the administrative dossier, as well as the text of the challenged decree, it is clear that the Decree seeks the internal organization of the SFE Registration Office, as an organ of minimum deconcentration of the Ministry of Agriculture and Livestock. It requests that the present amparo appeal be dismissed in all its aspects.” In this regard, the Chamber considers it necessary to clarify the scope of the regulations challenged in action No. 18-019039-0007-CO (concerning Executive Decree No. 39995-MAG) and that considered in this action (concerning Executive Decree No. 41481-MAG).

For the above, it is pertinent to cite the recital part or the preamble of both decrees, as they offer important insight into the objectives of the regulations in question.

The “Regulation for Updating Information in the Registration Dossiers for Technical-Grade Active Ingredient and Formulated Pesticides, No. 39995-MAG,” is based on the following premises:

“1. That one of the objectives of the Phytosanitary Protection Law is to regulate the use and handling of chemical, biological, or related substances and equipment for applying them in agriculture; likewise, their registration, importation, quality, and residues, while seeking to protect human health and the environment.

2. That the Phytosanitary Protection Law expressly establishes that all chemical, biological, or related substances and application equipment for agricultural use must be inscribed in the registry that the State Phytosanitary Service will create to have information available on their characteristics and to ensure their correct utilization in the country.

3. That agricultural pesticides are fundamental for combating pests that affect agricultural production and for the competitiveness of agricultural producers; therefore, it is essential to guarantee the supply and continuity of commercialization of products that currently have valid registration, making it necessary to update the information in their dossiers on their characteristics and to ensure their correct utilization in the country.

4. That the regulations prior to the entry into force of Executive Decree No. 33495 MAG-S-MINAE-MEIC of October 31, 2006, and its amendments, allowed the Ministry of Agriculture and Livestock to grant registrations for an indefinite term, as well as the inscription of formulated pesticides without the prior registration of the technical-grade active ingredient (TGAI) being a requirement; therefore, it is necessary to update the information for these registrations and also to establish a validity period for them equal to that of the registrations granted under the current regulations.

5. That international regulations establish toxicological, ecotoxicological, and environmental fate information requirements indicated in Executive Decree No. 33495-MAGS-MINAE-MEIC of October 31, 2006, and its amendments, which were not required by previous regulations; therefore, it is necessary to extend the registrations granted before said executive decree so that they can enter a registration process in accordance with the requirements of the current regulations, while simultaneously guaranteeing the continuity of their commercialization, given their importance as a tool for combating agricultural pests.

6. That both the Food and Agriculture Organization of the United Nations (FAO) and the World Health Organization (WHO) recognize that the repetitive generation of studies and information regarding all potential/real risks for each manufacturer of a pesticide may be unnecessary and ethically undesirable.

7. That the Cost-Benefit Evaluation Form was completed in Section 1, called Prior Control of Regulatory Improvement, resulting in a negative outcome and that the proposal has no procedures or requirements.” Meanwhile, the premises of the “Reform Regulation for Updating Information in the Registration Dossiers for Technical-Grade Active Ingredient and Formulated Pesticides,” No. 41481 – MAG, are the following:

“WHEREAS 1.- That through Executive Decree No. 39995-MAG of December 15, 2016, published in Gazette No. 11, Supplement No. of January 16, 2017, the Regulation for Updating Information in the Registration Dossiers for Technical-Grade Active Ingredient and Formulated Pesticides is decreed.

2.- That the State Phytosanitary Service, hereinafter (SFE), following a consultation from its Internal Audit to the Office of the Attorney General of the Republic, suspended the application of Decree 39995-MAG, and currently, due to a lack of procedure, the information for none of the registrations of Technical-Grade Active Ingredients, hereinafter (TGAI), and formulated products that do not have TGAI registration and were not inscribed in accordance with Executive Decree No. 33495-MAG-SMINAE-MEIC of October 31, 2006, and its amendments has been updated.

3.- That the Office of the Attorney General of the Republic, in response to the SFE Internal Audit consultation, issued Opinion No. C-199-2017 of September 8, 2017, concluding regarding Executive Decree 39995-MAG that: "it is a revalidation of previous registrations, inscribed under another regulation, and does not refer to an inscription procedure per se. Furthermore, as established in subsection 6, it intends to set a validity period for these registrations that were previously indefinite." "Therefore, it is not apparent from said Decree that it is a technical regulation requiring the consultation procedure with the Technical Regulation Body. On the contrary, it is the development of the provisions of Article 23 of the Phytosanitary Protection Law.

4.- That both national legislation and international regulations establish that the confidential information provided by registrants in registration processes and dossier updates, due to its regime of protection and commercial sensitivity, must be kept by the authorities in a diligent and appropriate manner, to guarantee its inviolability and prevent misuse.

5.- That international specifications and standards of first-world countries and regions, as well as internationally recognized and prestigious organizations, are a technical and scientific reference for determining that the technical-grade active ingredients synthesized by the manufacturers proposed in the dossier update processes do not contain relevant impurities at levels higher than the international standards or specifications, and relevant impurities are those that have toxicological or ecotoxicological relevance, which can cause harm to health or the environment.

6.- That technical-grade active ingredients are used solely for the formulation of synthetic chemical pesticide formulations and are only exceptionally used directly in the field, and these exceptional situations are already regulated in the current technical regulations; therefore, registration certificates for technical-grade active ingredients are only useful for authorizing, by the State Phytosanitary Service, the importation of these as raw material for pesticide formulations in processing plants and not for direct field use.

7.- That Executive Decree 39995-MAG, repeatedly cited, established a twenty-four-month period for updating the Registration, which expires on January 16, 2019, and that there is currently no procedure in place allowing its application; therefore, it is timely and convenient to establish a new reasonable period for the application of the mentioned decree and the procedures.

8.- That the approval of the Directorate of Regulatory Improvement of the Ministry of Economy, Industry, and Commerce has been obtained, according to Report DMR-DAR-INF-149-18, of December sixth, two thousand eighteen.” (The highlighting does not correspond to the original).

Thus, it is reiterated that the regulation under examination applies only to old products; that is, products for which TGAI or formulated registrations have already been granted, and many of these registrations were granted for an indefinite term. This means that they do not require the updating decree to continue being commercialized. Therefore, more than facilitating, the aim is to impose an obligation on them to update their information and provide data and studies that attest not only to the provenance and origin of the technical materials and associated formulations but also to provide the confidential chemical information that allows the registration authority, i.e., the SFE, to have available the confidential chemical information on purity, impurities, synthesis method, etc., of its technical materials, both regarding manufacturers and formulators. It is precisely based on the detail of the information provided that the registration authority will be able to make regulatory decisions regarding the continuity or not of a registration or of a manufacturer of a technical material for a formulation marketed in Costa Rica. As emphasized above, failure to undergo this registration update procedure may lead to action in accordance with Article 24 of the Phytosanitary Protection Law. Likewise, with the complete registration information, decisions can be made in light of what Article 30 of the same law expressly regulates:

“Art. 30.- Prohibitions and restrictions for technical reasons The Ministry of Agriculture and Livestock may restrict or prohibit the importation, transit, re-routing, manufacture, formulation, repackaging, re-wrapping, storage, sale, mixing, and use of chemical, biological, or related substances and application equipment for agricultural use, when justified on technical grounds and their use is considered harmful to agriculture, health, or the environment.” It is observed that this police power empowers the State to evaluate products based on updated information and to adopt the corresponding decisions in the interest of safeguarding agriculture, health, or the environment.

Now, the claimant's grievance, beyond specifying aspects of the procedure in particular, focuses on questioning that, in their opinion, the Ministry of Health and MINAE should intervene. However, as already examined above, the fact that they did not participate in the adoption of the regulation, or in the process of updating the registration information, does not in any way per se imply a violation of Constitutional Law.

Now, although it was not detailed by the claimant in this section, it is worth noting that the presentation of information from other registration dossiers was endorsed by the majority of this Court in judgment No. 2022-26651, in light of the international technical legislation that permits it; therefore, regarding these aspects, it is necessary to adhere to what was stated in the referenced vote.

VIII.- REGARDING ART. 1 OF THE DECREE The claimant asserts that the partial amendment and addition to Executive Decree No. 39995 is a benefit to pesticide marketers, as they extend the time from the publication of the challenged decree, granting a benefit of five more years to those products without them having undergone a risk assessment, and granting that additional time for the registrant owners to submit the information. Even though this same section defines an exhaustive list of requirements, they consider it limited for conducting a risk assessment. They assume that what the ministerial office seeks with the promulgation of this type of document is to demand, order, or intimidate registration evaluators to confine themselves only to requesting limited information, which lacks technical and scientific basis to conduct a risk assessment according to national and international standards with decimated requirements. They question that in the offending article, the MAG again insists on the referenced information process, without own or proprietary information, as this regulation proposes. Thus, the Executive Branch and the pesticide industry seek to facilitate the trade of pesticides to the detriment of human and animal health and the environment.

Regarding this, the Minister of MAG explains that the challenged numeral maintains its scope of application in the sense that it cannot be used to register new pesticides, and the only thing that changes is related to the deadlines and one of the administrative requirements. Regarding the matter of deadlines, they consider it a matter of legality, as it is the competent authority's responsibility to define the deadlines within which certain acts must be performed and the deadlines that the administered must meet for their procedures under the regulation. Moreover, it is insisted that the competencies were delegated by the will of the legislator to the MAG through the SFE. From a technical and scientific viewpoint, the regulation allows the State to have all the information on purity, relevant impurities (name, content, and detection levels), total impurities, synthesis method, analytical methodologies for determining the TGAI and its relevant impurities, for all TGAIs registered as such or as components of a formulation, which were registered in Costa Rica under legislation and regulations different from Executive Decree No. 33495-MAG-S-MEIC-MINAET. The confidential chemical information required by this decree is key and essential, from an agronomic, toxicological, and ecotoxicological perspective, and unfortunately, it is not incorporated into the dossiers of these registrations. Much of the chemical information requested in the decree, especially that described in Articles 1 and 5, although it was indeed presented during the revalidation process, is completely outdated, as five to ten years have passed since the information was provided, and the authorities have not yet reviewed, much less approved, it. Furthermore, it allows the Costa Rican State to have updated information on the formulation sites and origins, the name and physical location of the formulators, as well as the product components and the detailed description of the formulation processes for all formulated products currently marketed in Costa Rica.

From a chemical and scientific point of view, it is guaranteed that no formulated pesticide marketed in Costa Rica can be registered, and therefore marketed, if it does not have an associated TGAI with levels of relevant impurities (which are those of toxicological and ecotoxicological importance) higher than the levels specified in the reference international standards (FAO, EPSA, IUPAC).

The PGR considers that it lacks the competence to address the technical aspects and the suitability of the requirements demanded to carry out the registration update. However, it does point out that the Chamber must technically assess whether the requirements set by the challenged regulation for the revalidation process allow for an adequate assessment of the environmental or health risk of the products, since a mere comparison of the texts of Decree No. 39995 and Decree No. 41841 shows that the technical requirements that Decree No. 33495 did contemplate were not added, but rather some points were eliminated and modified. Furthermore, it points out that the challenged decree modifies Articles 1.2.b and 6 of Decree No. 39995, which allow registering products through referenced information, but it maintains this possibility in several provisions and does not establish how the information will be verifiable, how to determine which international specification can be used, how to determine product equivalence, nor if the reference profile to be used must be a registration with complete information. By not precisely establishing the rules to which the competent authority must adhere to verify the information, it is possible that the update of registrations with referenced information that does not meet the indicated requirements may be allowed, and therefore, subject to what is provided in the technical criteria issued, this would imply the updating of product registrations without a prior assessment of the environmental and health risks of their application and the unconstitutionality of the articles that allow the use of referenced information without an adequate determination of equivalence.

Regarding this, the Chamber considers that with respect to what was reported by the PGR, it is appropriate to clarify the argument provided in light of the explanations given by the Minister of MAG. The PGR affirmed that a mere comparison of the texts of Decree No. 39995 and Decree No. 41841 shows that the technical requirements that Decree No. 33495 did contemplate were not added. However, as has been explained, these regulatory instruments regulate different scenarios, which would justify the requirement of different requisites. Decree No. 33495 regulated all the inscription procedures for new products, while Decrees No. 39995 and No. 41841 regulate a different de facto situation, because they apply to products that are already registered and in use in the national territory, but for which an update of their registrations must be carried out. This would justify the differentiated treatment questioned by the PGR.

Now, addressing the claimant's grievances, it must be indicated that the extension of the deadline is due to a practical situation that was justified in the decree's considerations. Specifically, that the application of the previous decree was suspended by virtue of an administrative decision that paralyzed the procedure that was being carried out:

“That the State Phytosanitary Service, hereinafter (SFE), following a consultation from its Internal Audit to the Office of the Attorney General of the Republic, suspended the application of Decree 39995-MAG, and currently, due to a lack of procedure, the information for none of the registrations of Technical-Grade Active Ingredients, hereinafter (TGAI), and formulated products that do not have TGAI registration and were not inscribed in accordance with Executive Decree No. 33495-MAG-SMINAE-MEIC of October 31, 2006, and its amendments has been updated.” (The highlighting does not correspond to the original).

The foregoing justifies the claimed deadline extension.

Then, the claimant's argument is reduced to stating that the requirements are limited and imply a way to intimidate the registrar so they do not request more information from the petitioners. Said argument lacks an adequate and reasonable basis, as it does not detail which requirements it considers insufficient. Moreover, regarding the application, it is nothing more than a mere subjective appreciation of a possible consequence of the regulation, which has no support in an objective element that can be inferred from the clause under analysis. Neither does the claimant's presumption that these regulations seek to facilitate the work of merchants have any basis, all of which was rejected and justified in the MAG report. Therefore, this Chamber deems that these grievances must be dismissed.

Regarding referenced information, this Court in judgment No. 2022-26651, as has been stated, conducted an analysis of the international technical legislation that allows submitting information from other registration dossiers and concluded that the possibility of using referenced information from registries of non-national authorities to process registration procedures is not unconstitutional, because it is justified by the international technical and scientific instruments that this judgment identifies. For this reason, regarding these aspects, it is necessary to adhere to what was stated in the referenced vote and dismiss the grievances.

IX.- REGARDING ART. 2 The claimant accuses that the proposed reform reduces the time for evaluators to make a decision, changing from three months defined in Executive Decree No. 39995 to one month in the modification proposed in Decree No. 41481-MAG. They argue that this shows that what is sought in this type of regulation is a benefit for the companies selling agrochemicals, so that registration analysts carry out the analysis under time pressure, without a workload study to determine the proposed time. They add that worst of all is that the analysis proposed in this decree is defined as a simple verification of chemical documents; that is, whether the registrants submitted the information or not. However, the degree of lack of coordination is such that this verification of documents, which are of a chemical nature, is assigned to agronomy professionals, who do not have the competencies or the training to perform this task. This proposed approach is a new registration modality carried out only with a simple “checklist” or verification list.

The Minister of MAG maintains that on this point, the complaining party limits itself to objecting to purely legal matters and omits any reference to the alleged unconstitutionalities of the regulation it objects to. They note that, even from a pure and simple reading of the text, it is evident that the claimant's assertion that registrations are being granted to new products through this regulatory framework is false. They add that it is also not true, as the claimant asserts, that agronomists are in charge of reviewing the chemical information; but beyond the inaccuracies and fallacies the claimant incurs, it is clear that their allegations concern administrative aspects and matters of mere legality that are not for the Constitutional Chamber to resolve but for the ordinary jurisdiction.

The PGR considers that the unconstitutionality of Article 2 must be declared if, based on the technical criteria submitted to the case file, it is determined that the reduction of the deadline from three months to one month for the SFE to verify and analyze the information submitted and resolve the product update request and grant the registration certificate prevents an adequate assessment of the environmental and health risk of the product. They add that, without prejudice to what is resolved regarding that article, it is advisable for the Constitutional Chamber to clarify whether the rule that the figure of positive silence does not apply in the case of environmental approvals or authorizations is applicable, and that, therefore, non-compliance with the deadline set for the Administration would not imply the automatic approval of the product revalidation.

The current regulation, compared to the original decree, establishes the following:

Regulation for Updating Information in the Registration Dossiers for Technical-Grade Active Ingredient and Formulated Pesticides, No. 39995-MAG Reform Regulation for Updating Information in the Registration Dossiers for Technical-Grade Active Ingredient and Formulated Pesticides, No. 41481 – MAG ART. 2 For formulated pesticides whose TGAI is not registered, and whose dossier has been updated in accordance with the preceding article, the State Phytosanitary Service shall grant, within a period not exceeding three months, counted from the date on which the update was approved, the corresponding TGAI registration.

ART. 2 Once the manufacturer's update application is received, or when the applicant has provided the information that was required, the SFE shall proceed within a period of thirty days to verify that the technical-grade active ingredient synthesized or manufactured by the manufacturer proposed in the update application does not contain relevant impurities at levels higher than international standards or specifications, as well as verify that the technical-grade active ingredient is not included in Annex III of the Rotterdam Convention, or in the Stockholm Convention, or in the Montreal Protocol.

The evaluation of the chemical information by the SFE shall aim to verify that the required confidential and non-confidential chemical information is complete, that the tests and analyses were performed with the technical material synthesized or manufactured by the manufacturer or formulator, as applicable, proposed in the update application, and that the confidential chemical information corresponds to the TGAI synthesized by the proposed manufacturer; upon completing the foregoing verification, the State Phytosanitary Service shall proceed to issue, within the period indicated in this article, the resolution approving the update application.

(Thus amended by Article 2 of Executive Decree No. 41481 of December 10, 2018) For the Chamber, the arguments of unconstitutionality lack an adequate basis. The mere fact that resolution deadlines are reduced does not mean that this procedure in itself is less protective or harmful to constitutional provisions. It must be presumed that by virtue of the constitutional principles that must govern the functioning of the entire Public Administration, the SFE authorities—as legally designated for the resolution of this type of procedure—must resolve the registration update application efficiently and promptly; but, in the same way, they have the paramount obligation to ensure phytosanitary protection as a matter of public interest.

It is also worth highlighting that many of the grievances raised by the claimant are based on a generic premise that the requirements are insufficient and that means are being facilitated so that, in their application (reduction of deadlines and competent authority), the merchants of these products are favored. In this regard, this court observes that there is no appropriate substantiation regarding the requirements (which ones are sufficient and which are not), and the claimant does not refer to the potential manner in which the Administration (SFE) will exercise its competencies. This, moreover, would not be the subject of an unconstitutionality action, but rather of a control that must be carried out by the entire Public Administration and the ordinary jurisdiction, to ensure that the legally assigned competencies are exercised with rigor and efficiency.

Neither is there any evidence in the questioned regulation that this evaluation is carried out by agronomy professionals and that they lack the competencies or expertise necessary to make an appropriate assessment of the documentation submitted, always safeguarding the environment and human health.

Regarding what was stated by the PGR, this Chamber considers that their presumptions likewise start from an incorrect premise, because they refer to “granting the registration certificate”; however, as has been explained, the regulation in question does not properly regulate the registration of products, since these are already on the market; rather, what is required is the update of all their registration information. Now, concerning the request for clarification made by the PGR, this Court deems it clear that for everything related to inscription—which is not the case for the regulation under analysis—or to updating information in registrations, the institute of positive silence does not apply. In our legislation, the application of positive silence has been permitted—from the moment the application with its formal requirements has been submitted before the competent body and in the manner required by law—only for those procedures of the administered related to licenses, permits, authorizations, or when a specific regulation expressly authorizes it. The purpose of this legal figure is to provide the administered with a regulated and swift way to resolve their applications when, for one reason or another, the Administration has delayed in providing legal certainty on what was requested. However, for a long time, this Court has been emphatic in pointing out that in environmental matters—not only because of the protection of the environment itself but also because of the impact it has on people's health—positive silence does not operate. For example, since judgment No. 1994-6332, the following has been considered:

“The point under discussion in this amparo appeal is the applicability or not of the legal figure of positive silence with respect to the license or authorization requested—by the appellant—for the scientific collection of scarlet macaws. In this regard, this constitutional body has held that in general terms, positive silence operates in the face of the Administration's inertia and in those cases where the applicant has met all the requirements for its granting, but the fact is that the protection and preservation of the integrity of the natural environment is a fundamental right, such that it cannot be understood that positive silence proceeds simply due to the lapse of the period within which the Administration should have ruled on the permit for obtaining wild specimens of "Ara Macao" for scientific conservation purposes in the Central Pacific region. Hence, the Fundación Pro Iguana Verde cannot derive subjective rights in application of the aforementioned legal institute, because the public interest represented by the State in its obligation to ensure the right of every person to enjoy a healthy and ecologically balanced environment prevails over the private interest of wildlife exploitation.” (Criterion reiterated in judgments numbers 1999-01149, 2000-01375, and 2006-14479).

Such considerations were replicated by this Chamber in judgment No. 2016-017375, which concluded the following: “it has also been stated clearly that in this environmental matter, the figure of positive silence likewise does not operate.” Regarding the registration of medications—which clearly has an impact on people's health—the Chamber has also warned of the inapplicability of positive silence (silencio positivo). In judgment No. 2006-000688, the following reflections were set forth:

"The importance embodied by this precious right, as well as the duty of the Administration, granted at the constitutional level, to ensure its protection, allows the conclusion that it would be contrary to the Social State of Law advocated by our Magna Carta to permit the application of the concept of positive silence in the matter of medication registration. This Constitutional Court considers that the aforementioned medication registration procedure carried out by the Ministry of Health requires a meticulous technical analysis that allows it to conclude with certainty whether the product in question does not represent a danger to the health of the country's inhabitants; for which reason it is indispensable that said procedure be carried out efficiently. In light of the foregoing arguments, this Chamber deems it necessary to clarify that the figure of positive silence, especially in cases such as the present one, can in no way be conceived as the mere passage of the deadline during which the Administration was supposed to rule on a matter; this is because the protection of the right to health is at stake (in this regard, see Resolution No. 1999-1149 of 7:33 p.m. on February 17, 1999)." The jurisprudential guidelines of this Chamber in environmental matters were collected in the Ley Forestal No. 7575 of April 16, 1996, which states the following:

"Art. 4.- Positive silence In matters of natural resources, the positive silence contemplated in Articles 330 and 331 of the Ley General de la Administración Pública shall not operate.

When the State Forest Administration does not resolve matters submitted for its consideration within the deadlines stipulated in the Ley General de la Administración Pública, the responsible official shall be subject to the sanctions set forth in the laws." (As amended by Article 1 of Law No. 10072 of November 18, 2021. The emphasis does not correspond to the original).

Likewise, they were collected in the recent amendment made to the Ley de Protección al ciudadano del exceso de requisitos y trámites administrativos No. 8220, which, as relevant, warns the following:

"Exempted from the application of positive silence are licenses, permits, and authorizations in matters of public health and the environment, and those matters in which, by constitutional provision, law, or judicial jurisprudence, they are expressly so indicated. Each institution must expressly indicate, in the Catálogo Nacional de Trámites, for which specific cases this figure is not applicable, under penalty of incurring an administrative fault on the part of the Trámite Simplification officer." (The emphasis does not correspond to the original).

Therefore, in accordance with the reiterated jurisprudence of this Chamber and the current legal regulations, it is understood that for procedures related to the registration or updating of pesticides, due to their clear impact on the environment and people's health, the administrative figure of positive silence does not apply.

Finally, it is worth emphasizing that if the trading parties do not comply with this procedure for updating requirements within the established deadlines, the Administration is empowered to apply the relevant legal provisions and may cancel the registration (Art. 24), and the person is subject to the corresponding fines (Art. 76, both of the Ley de Protección Fitosanitaria).

X.- REGARDING ART. 3 The petitioner asserts that, once again, the ministerial office shortens the time established in Executive Decree No. 39995 for the benefit of users, without knowing whether there is a technical workload study that supports such a decision to change from three months to ten days for the technical evaluation to be carried out by SFE officials, as this decree unilaterally excludes the corresponding ministries from participation in health and environmental matters.

He specifically questions the paragraph that states that "for formulated pesticides that do not have a registration of a technical-grade active ingredient associated with that formulation and whose manufacturer of that formulated product has been updated in accordance with this regulation, the SFE shall grant the certificate of registration of the technical-grade active ingredient." He considers that this decree opposes any active technical-scientific principle governing registration matters, as it amounts to granting a registration without even mediating a basic process that governs registration regulations, which is chemical evidence.

Regarding this provision, the Minister of MAG reiterates his technical explanation about the purpose of this regulation:

"As we had already pointed out, in Costa Rica before January 10, 2007, the registration system established that a formulation could be registered without needing a registration of the raw material, i.e., its technical-grade active ingredient (IAGT). After that date, it was established that every formulation, prior to being registered, required the registration of its IAGT. This means that currently, an enormous number of approximately fifteen hundred formulated products are not associated with a manufacturer. That is why Executive Decree No. 39995-MAG of December 15, 2016, and its amendment (Executive Decree No. 41481-MAG of December 10, 2018, published on January 11, 2019, Issue No. 8 of the Official Gazette La Gaceta), establishes an updating process that will allow the registration system to guarantee that every formulation marketed in the country will be associated with a manufacturer of the IAGT. Thus, this updating of the manufacturer does not imply that registration is being granted to a new product; rather, through this updating process, the authority will have the necessary information to determine if the technical material with which that formulated product is made does not contain relevant impurities and also complies with the international specification that every IAGT must meet for the formulation of pesticides. Therefore, what the petitioner indicates regarding the lack of technical or scientific basis, and the confusion with registration under the equivalence modality, is incorrect, because the process does not propose an equivalence but rather an update of the information of a current registration of a formulated product that does not have a manufacturer of IAGT associated with its registration, recalling that by virtue of Article 3, it is not that a new product is being authorized, but rather that a manufacturer is being associated with that formulation that already has a registration and is marketed in the country." Furthermore, he notes that the questions about deadline aspects and workloads are discussions of mere legality and not constitutionality.

The rule in question, compared to the previous one, provides the following:

Reglamento para la actualización de la información de los expedientes de registro de ingrediente activo grado técnico y plaguicidas formulados, No. 39995-MAG Amendment to the Reglamento para la actualización de la información de los expedientes de registro de ingrediente activo grado técnico y plaguicidas formulados, No. 41481 – MAG

Regarding the grievances raised, the Chamber observes that the arguments about the definition of deadlines and the workloads of the SFE, and the exception of the participation of the Ministries of Health and Environment and Energy, have already been addressed in the preceding sections. The mere circumstance that resolution deadlines are reduced does not in itself imply an injury to Constitutional Law, and the fact that the competencies for updating registrations are concentrated in the SFE is a consequence of a legal provision (Art. 23 of the Ley del Servicio Fitosanitario del Estado), which inherently shows no indication of unconstitutionality, nor has it been challenged.

Regarding the registration, the minister's explanations must be revisited, in the sense that this procedure does not imply granting a new registration as such, but rather updating all the missing information of the product, allowing the authorities to determine if it contains relevant impurities that warrant some type of reassessment of the registration. As has been repeatedly emphasized, the procedure regulated by the regulations under review is for products that are already registered and on the market (an administrative authorization already exists), so information is requested for the purpose of re-evaluation. Furthermore, as seen in the reports transcribed in this judgment, previously the validity of the registrations was provided for indefinitely, whereas the regulations under analysis introduce caps and limits to that registration.

XI.- REGARDING ART. 4 (which amends Art. 5 of Decree No. 39995) The petitioner insists that the registration facilitation process established by Executive Decree No. 41481 (noting that the text used in the original source, “n.°414131,” appears to be a typo) goes against the State's duty to protect all of Costa Rican society. He deems that only requirements are listed to get by, and that they will not support any information for conducting a technical-scientific risk analysis evaluation.

The Minister of MAG explains that, when analyzing Art. 5, the petitioner confuses the concept of manufacturer (fabricante) with that of formulator (formulador), such that the entire hypothesis, the objections, and the analyses made of said rule are not applicable to the legal situation regulated by the updating of formulators under Executive Decree No. 39995-MAG of December 15, 2016, and its amendment No. 41481-MAG.

The rule in question, compared to the previous one, provides the following:

Reglamento para la actualización de la información de los expedientes de registro de ingrediente activo grado técnico y plaguicidas formulados, No. 39995-MAG Amendment to the Reglamento para la actualización de la información de los expedientes de registro de ingrediente activo grado técnico y plaguicidas formulados, No. 41481 – MAG

In the Chamber's opinion, the petitioner does not properly substantiate the reasons why he considers that the requirements demanded therein "will not support any information for conducting a technical-scientific risk analysis evaluation." It is a generic argument, so this Court cannot conduct a rigorous constitutional review in this regard.

Furthermore, it is necessary to reiterate the criteria of this Chamber in judgment No. 2009-008917, which established the following:

"In the first place, the petitioners request that the unconstitutionality of Articles 1, 7, and 8 of Law No. 8702, called Trámite de Solicitudes de Registro de Agroquímicos, be declared, arguing that the law does not require a series of essential technical requirements that, in their judgment, must be required in order to register an agrochemical, and therefore these omissions contravene the fundamental rights to health and a healthy and ecologically balanced environment. In this regard, it is worth mentioning that although this Constitutional Court is empowered to act as a negative legislator, with the power to annul from the legal system all those norms it considers unconstitutional, the truth is that it is prevented from acting as a positive legislator creating norms. On the other hand, even though this Chamber is competent to hear legislative omissions as established in Article 73 of the Ley de la Jurisdicción Constitucional, it is important to clarify that not every normative omission can be challenged through this avenue. In that sense, only those omissions that occur as a consequence of an express and direct mandate contained in the right of the Constitution can be subject to constitutionality control through this action. Now, in the specific case, the omissions challenged by the petitioners do not stem from an express mandate of the constituent power; rather, they are omissions that they claim to find in the text of the law, without the duty to legislate in the sense explained by the actors stemming from the Political Constitution. Likewise, since this is a Court that acts as a negative legislator, it is clear that a potential favorable ruling, with the consequent elimination of the norm, would not remedy the omissions indicated by the petitioners; therefore, the action filed in those terms lacks utility and is therefore manifestly improper. On the other hand, it is observed that, in essence, what the petitioners seek is for this Chamber to determine whether the requirements that the norms demand for the registration of an agrochemical are technically and scientifically appropriate or not, and, if they are not, to rule on the list of requirements that, in their judgment, the regulations should contain. However, it is necessary to state that this Tribunal is not the competent body to exercise that function, as that is a competence assigned to the legislator, who, in use of their discretionary powers, is responsible for designing the legal procedures and requirements that must be met for the registration of agrochemicals in the country. Only in those cases where the legislator exceeds that discretionary power to the direct detriment of the fundamental rights of individuals can this Chamber validly hear and rule on the matter. However, since in this case what is challenged is not the text of the norms themselves or the legislator's discretion, but rather what, in the actors' opinion, the law omits, this Tribunal cannot rule in order to supplant competencies and establish those requirements. Under such circumstances, the action is inadmissible." (The emphasis does not correspond to the original).

This ratio must be replicated in the specific case insofar as, as noted, there is no precision in the petitioner's substantiation, and the Chamber cannot arrogate to itself the power to make technical and scientific determinations as to whether the requirements demanded in the provision in question are or are not sufficient to fulfill the mandate of the legislator and the constitutional mandates derived from Articles 21, 46, and 50 of the Constitution.

XII.- Regarding Art. 5 (which amends Art. 6 of Decree No. 39995) The petitioner asserts that the chemical equivalence (equivalencia química) process proposed in this article contravenes international standards, Constitutional Chamber judgment No. 2011-016937, and the reports of the CGR. He argues that a procedure for the evaluation of equivalence (evaluación de la equivalencia) in formulated products has not been proposed by these institutions. Furthermore, he questions that the database does not constitute any solution.

The Minister of MAG responded to these grievances by explaining that Art. 6 of the challenged decree guarantees, in its current wording: first, that Costa Rica will cease to have registrations with an indefinite term, because as of the update, all registrations of IAGT and formulated products will have a validity of ten years, imposing the obligation to renew them, unlike now where, being for an indefinite term, they do not have to be renewed as they have no expiration date; second, that all formulations currently sold on the market will have an associated manufacturer, unlike now where the sites and origins of manufacture of the raw materials are unknown; third, that every IAGT used in Costa Rica for the formulation of products authorized for commercialization in Costa Rica has its purity accredited and does not have relevant impurities exceeding international specifications; fourth, that all IAGTs used in Costa Rica comply with the international conventions signed by Costa Rica (Annex III of the Rotterdam Convention, the Stockholm Convention, or the Montreal Protocol); and fifth, that the SFE will create a database of toxicological, ecotoxicological, and environmental fate (destino ambiental) information on the technical-grade active ingredients that are registered and do not have current periods of test data protection. He affirms that it is very important for the SFE to have an information bank for molecules that are not new and whose test data are free to use because they do not have current protection periods. Furthermore, it is necessary for companies that have toxicological, ecotoxicological, and environmental fate information on technical-grade active ingredients that are not new to contribute information they have managed to compile, which will help the SFE in the future to build a comprehensive toxicological, ecotoxicological, and environmental fate and behavior profile, allowing for a reference profile for equivalence registrations (registros por equivalencia).

In this regard, the PGR maintained that by not precisely establishing the rules to which the competent authority must adhere to verify the information, it is possible that the update of registrations may be permitted with referenced information that does not meet the indicated requirements, and therefore, this would imply the updating of product registrations without a prior evaluation of the environmental and health risks of their application. If the foregoing is verified, according to the technical criteria issued for this purpose, this would imply the unconstitutionality of the articles that allow the use of referenced information without an adequate determination of equivalence (determinación de equivalencia).

The rule in question, compared to the previous one, provides the following:

Reglamento para la actualización de la información de los expedientes de registro de ingrediente activo grado técnico y plaguicidas formulados, No. 39995-MAG Amendment to the Reglamento para la actualización de la información de los expedientes de registro de ingrediente activo grado técnico y plaguicidas formulados, No. 41481 – MAG

Regarding the petitioner's assertions, this Chamber considers them to be imprecise and confusing, and that it is not appropriate to supply the argumentation that would correspond to him to make. This Tribunal has already warned of the following:

"The Chamber could not, for example, engage in judicial activism or substitute the petitioner in his duty to argue. For this reason, the judgment must also be '… congruent with what was sought …' in the filing brief." (Judgment No. 2022-026592).

In the case at bar, the petitioner indicates that there is no procedure for the evaluation of equivalence; however, he omits to point out in which instruments it is required that the authorities, in addition, must detail a procedure for the evaluation of equivalence, which prevents this Chamber from conducting a rigorous analysis of the issue. In any event, this mechanism—that of using reference profiles—was examined in another action that was dismissed in judgment No. 2022-26651. It was also extensively assessed in judgment No. 2022-023238, in which it was explained that it is not an automatic procedure, but rather requires adequate analysis and substantiation, which must be controlled in each specific case. Consequently, this Chamber refers to the considerations made in those resolutions.

Furthermore, it is observed that the rule under analysis also requires that, in the absence of the equivalence report, it be verified that the IAGT does not contain relevant impurities at levels higher than international standards or specifications, as well as that the technical-grade active ingredient is not included in Annex III of the Rotterdam Convention, the Stockholm Convention, or the Montreal Protocol. Thus, standards for carrying out the analysis in question are expressly established. The SFE authorities, as has been warned, must be diligent and demanding in this matter, given that people's health and a healthy and ecologically balanced environment are at stake. Therefore, in the registration and information update procedure, said authorities are obliged to apply the highest standards of protection to these fundamental rights and to be respectful of the precautionary principle. Equally, they are obliged to stay updated and adjust to technical developments or international standards in phytosanitary protection. Indeed, as was already warned supra and it is worth insisting, this Chamber draws attention to warn that—given the slightest trace of doubt—they must require all pertinent documentation or studies, with the purpose of verifying that the product whose registration is to be updated meets the parameters and conditions necessary to safeguard human health and food safety. Likewise, they are required to ensure that its use is appropriate and has the desired effects. Rigor in the selection of studies is as important as the subsequent controls that can be carried out on the application and use of the products.

Consequently, based on what was indicated by the petitioner, an injury to Constitutional Law is not proven.

XIII.- Regarding Art. 6 (which amends Art. 7 of Decree No. 39995) The petitioner accuses that this article contains an unscientific registration proposal, which departs from national and international norms, and could be unconstitutional as it violates the precautionary principle.

He argues that the Executive Branch promulgated this decree which, in keeping with its objective, should have been titled “regulations for registry facilitation,” where the priority is the updating or revalidation of registrations with referenced information, pressuring registry analysts by shortening response times, proposing the registration process with only a simple verification of information and separating the Ministries of Health and Environment in their registry analysis.

The Minister of MAG states that the current text bears no relation or consistency with the reckless comments and assertions made by the petitioner regarding this specific article. With respect to the assertion that this regulation inverts the burden-of-proof principle or the precautionary principle, he rejects it “absolutely and categorically,” not only because it is a matter of legality to be discussed in the ordinary jurisdiction, but also because the current text of Article 7 is supported by repeated opinions of the PGR and rulings of the Constitutional Chamber. He reiterates that it is incorrect and reckless to indicate, as the petitioner does, that the challenged decree violates the precautionary principle in environmental matters, just as it is also incorrect to affirm, as the petitioner does in this fact and in his arguments, that the burden of proof is inverted.

He points out that the regulation challenged in this action does not allow or make it possible to grant registrations for new products in addition to those already marketed, because its scope of application is very clear and can only be applied to current registrations that were granted under regulations (legal or regulatory) other than Decreto Ejecutivo No. 3495-MAG-SMINAE-MEIC and its amendments. He adds that this regulation will not grant registrations for TGAI and much less for formulations not already on the market. Regarding agrochemicals registered and currently marketed in the country, there is no additional danger resulting from its application with respect to human health, the environment, or the biological efficacy of the pesticide. Therefore, it is not correct to maintain that, with the application of the decree, the registrations updated in their files pose an additional risk to health, the environment, or agriculture, since all, absolutely all, TGAI registrations granted must necessarily and unavoidably correspond to one of the formulations already sold on the market, and over these formulations, the Ministries of Health or Environment have broad and indisputable powers and authority to adopt the pertinent measures to prevent harm to health or the environment.

The PGR reiterates that this does not negate the constitutional duty that, by virtue of the precautionary principle, the competent authorities have to apply the powers set forth in Articles 25 and 30 of the "Ley de Protección Fitosanitaria" and Article 5 of the "Ley para la Importación y Control de la Calidad de Agroquímicos," to “deny, suspend, or cancel the registration of chemical, biological, or related substances,” “restrict or prohibit the importation, transit, redestination, manufacture, formulation, repackaging, rewrapping, storage, sale, mixing, and use of chemical, biological, or related substances and application equipment for agricultural use, when justified for technical reasons,” and “prohibit the circulation or order the destruction of products that do not comply with quality standards, as well as take other measures aimed at improving the quality of agrochemicals.” The regulation in question, comparatively with the previous one, stipulates the following:

In the Chamber’s opinion, contrary to what was stated by the petitioner, which is actually a reiteration of the previously examined defects, the regulation in question authorizes the SFE to initiate the corresponding administrative procedures for the annulment of the registration—it should be remembered that this regulation applies to products already in use on the market—and, moreover, reiterates the possibility of exercising the powers legally granted in the matter. The fact that the reform of the decree in question does not expressly cite the “competent ministries,” but rather centralizes the oversight power, just as it is in the law, does not in any way mean that other powers legally granted to other ministries, which would authorize them to adopt administrative measures to safeguard human health or the environment, are disregarded.

It must be remembered that the management of the registration is the responsibility of the SFE, so it is logical that this authority is the one charged with initiating the corresponding procedure for the annulment of the registration. In this regard, emphasis must be placed on the legal power provided for in Article 30 of the "Ley de Protección Fitosanitaria," which precisely entrusts the MAG with the decision to restrict or prohibit the importation, transit, redestination, manufacture, formulation, repackaging, rewrapping, storage, sale, mixing, and use of chemical, biological, or related substances and application equipment for agricultural use, when justified for technical reasons and their use is considered harmful to agriculture, health, or the environment. Thus, the challenged regulatory provision reflects that police power vested in the MAG.

However, nothing in the challenged article renders ineffective other legal powers that, as noted supra, are of public order and could, for example, urge the MAG or present the corresponding evidence so that the SFE initiates the procedure that pertains to it. It must be remembered, as already noted supra, that plant protection measures are rooted in our Social State under the Rule of Law, as they seek to protect health (Article 21), the protection of consumer rights specifically to health and the environment (Article 46), as well as the stimulation of agricultural production, so important for our country, in parallel with the protection of the environment (Article 50). Therefore, the authorities must carry out oversight jointly.

For example, the "Ley General de Salud" contains the following powers in favor of the Ministry of Health:

“Article 213.- Every person, natural or legal, engaged in producing food must do so under sanitary environmental conditions and using defense or conservation techniques approved by the health authority, in order primarily to prevent the contamination of such products and their danger due to the presence of toxic residues from their treatment with pesticides or other defense or conservation systems.” “Article 244.- Natural and legal persons who import, manufacture, handle, store, transport, trade, supply, or apply substances, mixtures of substances, or products called pesticides by the plant health law, shall be subject to the regulatory provisions that the Ministry dictates by mutual agreement with the Ministry of Agriculture for the safeguarding of people's health in accordance with that law; interested parties must register every pesticide or product intended for the control or extermination of infestations and request prior permission to operate when such substances, mixtures of substances, or products that, due to their nature or use, are not included in the mentioned law are capable in any way of causing poisoning or serious harm to the health of people or animals useful or harmless to man.” “Article 245.- Natural or legal persons dedicated to pest control may operate only with the Ministry’s permission using the substances, mixtures of substances, products, and product mixtures authorized by the Ministry and subject to the pertinent technical standards, in order to prevent accidents or harm to the health of the people performing such tasks or third parties.” (The emphasis does not correspond to the original).

Likewise, the "Ley Orgánica del Ambiente" stipulates the following:

“Article 59.- Environmental pollution. Pollution is understood as any alteration or modification of the environment that could harm human health, threaten natural resources, or affect the environment in general of the Nation. The discharge and emission of pollutants shall be obligatorily adjusted to the technical regulations issued. The State shall adopt the necessary measures to prevent or correct environmental pollution.” “Article 60.- Prevention and control of pollution. To prevent and control environmental pollution, the State, municipalities, and other public institutions shall give priority, among others, to the establishment and operation of adequate services in fundamental areas for environmental health, such as:

• a)The supply of water for human consumption.
• b)The sanitary disposal of excreta, wastewater, and stormwater.
• c)The collection and management of waste.
• d)Control of atmospheric pollution.
• e)Control of noise pollution.
• f)Control of chemical and radioactive substances.

These services shall be provided in the manner determined by specific laws and regulations, seeking the participation of the population and its organizations.” “Article 61.- Environmental contingencies. The competent authority shall dictate the necessary preventive and corrective measures when contingencies due to environmental pollution and others not contemplated in this law occur.” (The emphasis does not correspond to the law).

Thus, it is pertinent to note that the fact that the challenged decree concentrates certain registration functions in the MAG and specifically in the SFE does not disregard or render ineffective other types of powers and legal authorizations provided in favor of the Ministry of Health and MINAE regarding the protection of public health and the environment. It was previously noted that the decree under review cannot be understood as a normative body isolated from the rest of the block of legality and constitutionality, and that the specific task of updating the information in the registrations and their review does not entail rendering ineffective the rest of the legal powers entrusted to other ministerial portfolios.

Similarly, it is not unnecessary to reiterate what was stated in the precedent transcribed supra No. 2017-06668, in the sense that to revoke a previously processed registration, the demonstration of an unacceptable risk (riesgo inaceptable) to human health, the environment, or agriculture is indeed required, and it contemplates a sovereign power of the public administration, such as the restriction or prohibition of use of a registration, even if there is a prior substantial legal situation in favor of the administered party, such as the registration. To that extent, the granted registration can be modified if there is evidence of an unacceptable risk, in which case, the Administration—understood in a broad sense—would be enabled to exercise sovereign powers and impose precautionary measures.

Therefore, an injury to the invoked precautionary principle is ruled out, and the grievance in question is dismissed.

XIV.- Concerning Article 9 (which amends and adds a new Article 11 to Decreto No. 39995).

The petitioner claims that continuing with the registration facilitation process and without any analysis responding to technical and scientific support in accordance with national and international standards, the Executive Branch proposes to homologate the uses of one product with another that has similarity of active ingredient (ingrediente activo), concentration, and formulation, when in this particular case the minimum that can be done is a chemical equivalence of the active ingredient, but since it refers to a formulation, the co-formulants must be analyzed, which must be declared, and the risk analysis must be able to be carried out by the ministries of health and environment, and a biological efficacy study must be presented respecting the univocal rules of science and technique.

The Minister of MAG states that the petitioner association provides nothing more than a transcription of parts of a CGR report, absolutely decontextualized and not applicable to the specific situation. He indicates that the homologation of formulations proposed in Article 11 of the challenged decree is based on the FAO and WHO manual of specifications for the development of pesticide specifications.

The challenged regulation establishes the following:

Article 9.- Article 11 is amended and added, and the numbering of subsequent articles is corrected:

‘ARTICLE 11. Within a period of thirty-six months, counted from the entry into force of this amendment, the holders of registrations of formulations with current registration may request from the Servicio Fitosanitario del Estado the homologation of the label and pamphlet, with respect to other already registered formulations of the same type, with the same TGAI and equal concentration, in aspects related to authorized uses, pests, approved crops, doses, modes of application, application ranges, and application intervals.

The Servicio Fitosanitario del Estado, through the agronomic evaluation area of the Registrations Unit, within a period of thirty days shall conduct an assessment of each specific case and verify that the value of the physicochemical properties of the formulated product complies with the parameters established in the technical regulations in force in the country or with those of the FAO or other international reference organizations to those presented by the already registered material. The resolution approving or denying the application shall be issued within a period of thirty days counted from the submission of the agronomic evaluation report. Together with the homologation application, the physical-chemical properties of the formulation, the pamphlet, and the label incorporating the requested changes must be provided.” In the Chamber’s opinion, the deficiency in the argument is that the petitioner again seeks for this Tribunal to technically prescribe how to carry out the procedure for evaluating products with respect to other already registered formulations of the same type with the same TGAI and equal concentration. This corresponds to an entirely technical decision over which this Chamber lacks the competence to make a determination. It appears, without a doubt, as a discussion of legality and not of constitutionality. Note that it concerns the homologation of labels and pamphlets for products that have notable similarities, so it does not seem reasonable to request, as the petitioner intends without further substantiation, a chemical equivalence study. Consequently, the grievance must be dismissed, without prejudice to the fact that this can be discussed more extensively in the ordinary channels of legality.

XV.- CONCLUSION As a corollary of the considerations made, it is necessary to declare the unconstitutionality action filed without merit.

Magistrates Cruz Castro and Rueda Leal dissent and would declare the action with merit for violation of the right to a healthy and ecologically balanced environment. Magistrates Cruz Castro and Rueda Leal set forth separate notes.

XVI.- DOCUMENTATION PROVIDED TO THE CASE FILE. The parties are warned that if they have provided any document on paper, as well as objects or evidence contained in any additional electronic, computer, magnetic, optical, telematic device or one produced by new technologies, these must be withdrawn from the office within a maximum period of thirty business days counted from the notification of this judgment. Otherwise, all material not withdrawn within this period will be destroyed, as stipulated in the “Reglamento sobre Expediente Electrónico ante el Poder Judicial,” approved by the Corte Plena in Session No. 27-11 of August 22, 2011, Article XXVI and published in Boletín Judicial No. 19 of January 26, 2012, as well as in the agreement approved by the Consejo Superior del Poder Judicial, in Session No. 43-12 held on May 3, 2012, Article LXXXI.

POR TANTO:

By majority vote, the unconstitutionality action is declared without merit.

Magistrates Cruz Castro and Rueda Leal dissent and would declare the action with merit for violation of the right to a healthy and ecologically balanced environment. Magistrates Cruz Castro and Rueda Leal set forth separate notes.

Fernando Castillo V.

Fernando Cruz C. Paul Rueda L.

Luis Fdo. Salazar A Jorge Araya G.

Anamari Garro V. Aracelly Pacheco S.

Res. nro. 2023002389 Dissenting vote of Magistrates Cruz Castro and Rueda Leal, authored by the latter. With the customary respect, we dissent and would declare the action with merit, for the following reasons.

As a starting point, we reiterate the opinion we expressed in Judgment No. 2022-026651 of 4:30 p.m. on November 9, 2022, whose considerations are, to a large extent, applicable to the sub lite:

“1.- Regarding the referenced use of data for registration. The majority resorts to the “International Code of Conduct on the Distribution and Use of Pesticides. Guidelines for the Registration of Pesticides” (April 2010) to establish the “acceptability of harmonized and clear registrations, the use of available information and mutual acceptance of data, the existence of information exchange mechanisms between competent authorities” as a “core” element in that technical regulation and to allege the existence of the “principle of non-repetition of studies.” In that sense, it transcribes point 3 of the cited code:

‘3. Principles of pesticide registration Responsible authorities, in managing their national or regional registration programs, should follow a series of important principles practiced internationally. The acceptance and use of these principles will ensure greater efficiency, transparency, and optimal use of resources during the registration process. These principles include the following:

Complete, harmonized, and clear criteria and requirements for registration; Use of all available information and mutual acceptance of data; Transparency and exchanges of information; Evaluation based on scientific grounds to determine whether precautionary measures are required; Consideration of hazards; Risk assessment and mitigation based on the local situation; Risk/benefit analysis, taking into account available alternatives; Post-registration monitoring and evaluation; Mechanisms for periodic and unscheduled reviews to respond to new information that may impact regulatory status; Protection of the intellectual property rights of the applicant.

The evaluation of data retained in the registration file should respect internationally accepted and agreed standards and procedures, to the extent they are available. These standards should be regularly updated to ensure their conformity with current scientific advances.

It is essential that all steps of the registration process are transparent, based on well-reasoned and published criteria and guidance documents, with complete information shared with the applicant on the outcome of the different steps of the registration process. Responsible authorities should ensure that the criteria and requirements for registration are complete and clearly defined. The same applies to data acceptance standards, data quality, the acceptability of formulated pesticide products for specific users and uses, or criteria for degradability or accumulation.

Governments should facilitate the exchange of information between responsible authorities through national institutions, international, regional, and sub-regional organizations, as well as public sector groups. They should develop legislation and regulations to enable the exchange of information with the public on the risks and benefits of pesticides and also to facilitate public participation in the country’s pesticide management.

Responsible authorities should, whenever possible, use data that have been placed in the public domain, and preferably those that have been previously reviewed, when considering a registration application. In this way, duplicated work and inefficient use can be minimized. The mutual acceptance of data by various regulatory authorities on topics such as efficacy and residues, among others, is recommended, provided that a solid basis can be established to ensure that the data are relevant to the situation being considered.’ Thus ended the majority’s citation. We consider that a proper assessment of the case requires, at a minimum, the transcription of the following two paragraphs of that same article:

‘Furthermore, hazard assessments are generally globally applicable and available from published sources, including peer reviews from the FAO/WHO Joint Meeting on Pesticide Residues (JMPR). These can be used in evaluating a dossier, provided that the ownership of the data is adequately taken into account.

Countries should fully evaluate the efficacy, behavior, fate, hazard, and risk of pesticides in relation to the various anticipated conditions of use in their country. Any registration procedure should include an evaluation of the potential risks related to the pesticide use for which the pesticide has been requested. The instructions for use, as indicated on the label, should cover these risks and prescribe the measures for their proper application, storage, handling, and disposal to mitigate such risks. In doing so, responsible authorities should also ensure that these measures can realistically be adopted by the user for whom the product is intended. Specific requirements under national policies for Integrated Pest Management (IPM) [5] and Integrated Vector Management (IVM) [6] should also be considered.’ (The underlining is added).

From the foregoing, contrary to what the majority judgment concludes, we consider that a full evaluation of the pesticide must be the rule. Our reading of that provision is that the mutual acceptance of data is a recommendation (the regulation textually states “The mutual acceptance of data is recommended…”) for the purpose of avoiding excessive procedures, such as duplicated work. However, the recognition of referenced information can never substitute for the full assessment of the pesticide.

The optional nature of the mutual acceptance of data also derives from Article 12 of the cited code, which makes such acceptance conditional on the relevance and quality of the data:

‘Mutual acceptance of data. If relevant data of good quality have been generated in other countries, the responsible authority could waive the requirement for generating local data. This is especially important for efficacy trials, residue data, and environmental field studies, all of which are likely to require the involvement of national (public) research institutions;’ Such relevance and quality, or conditions of equivalence, are lacking in the challenged decree.

The dissenters’ opposition to the use of referenced information, under the terms of the challenged regulation, was shared by the then Minister of Ambiente y Energía, who expressed himself in this process in the following terms:

‘This section seeks for those TGAIs that do not have their own information (the generics) to be updated, and subsequently registered, by submitting referenced information. This procedure is contradictory to the definition of referenced information established in Decreto Ejecutivo No. 40059-MAG-MINAE-S, which indicates “4.32. referenced information: For the application and interpretation of this regulation, it is the technical information from the reference profile, which may be used by the AC to evaluate an application for a TGAI registration by equivalence and which does not have a valid protection period.” In turn, the definition of reference profile indicates: “4.49. Reference profile or source: It is the information on which the risk analysis was based and for which a regulatory decision was made and the corresponding registration granted, and which will be used as the basis for equivalence registration, in accordance with the provisions of this regulation.” The comprehensive reading of these two definitions demonstrates that equivalence cannot be determined without the duly evaluated and registered reference profile, on which the referenced information is based. This procedure is not applied, according to what is contemplated in the cited DE 39995, which contradicts the provisions of the CGR. The Contraloría General de la República (CGR) in its report FOE-AM-19/2004 pointed out the SFE’s non-compliance with national and international regulations by tolerating registrants presenting information from other products (referenced information), without performing an equivalence analysis to verify whether such information is applicable to the new substance to be registered. Based on its analysis, the CGR ordered: “To immediately suspend the practice of registering agricultural pesticides using for this purpose information corresponding to another previously registered product, without having performed an equivalence analysis in accordance with the provisions of the FAO and WHO...” Likewise, the Constitutional Chamber in its Resolution No. 2011-016937 ordered the annulment of subparagraph b, and the reference in the penultimate paragraph to said subparagraph “b)” of section 7.3.2, of Article 2, of DE 33495-MAG-S-MINAE-MEIC, because that provision allowed equivalence to be made from a reference profile with incomplete data. It would be even worse to allow the updating of a registration with referenced data that have no direct relationship with the product being updated, which would be permitted by this regulation.’ Finally, concerning the use of existing evaluations of the same active ingredient and/or product, note that the aforementioned code limits the possibilities of such practice to specific cases:

‘6.3 Using existing assessments of the same active ingredient and/or product Aspects of existing registrations may be used for new applications based on the same active ingredients as long as the applicant owns the data or can fully justify the right to use the data for their registration application. However, if the data belong to another data owner and the applicant cannot justify the right to use those data, the responsible authority should not use the first registrant’s data and assessment to approve a second applicant’s product.’ (The underlining is added).

To that extent, we consider that the challenged regulation undermines the protection of the environment and public health by enabling the use of referenced information, to the detriment of a full assessment of the pesticide or product.

2.- Regarding the reduction of requirements. On this topic, the majority of the Chamber chose to consider that the action lacks adequate substantiation. In this regard, we indicate, on the one hand, that the lack of substantiation should be noticed and warned by the Chamber in a timely manner, under the terms of Article 80 of the "Ley de la Jurisdicción Constitucional." We recognize that the lack of substantiation may lead to the action being declared without merit when it reaches a decision on the merits.

However, such a course of action should only occur when it is not clearly evident from the case file that the claim is well-founded, as happens in the case at hand.

Thus, regarding this issue, the Office of the Attorney General of the Republic (Procuraduría General de la República) stated:

“…from reading article 1 of the challenged Decree it is possible to determine that for the revalidation process established therein, fewer requirements are demanded than those set forth in the revalidation process established by Decree 33495, since the latter required, in all cases, the confidential dossier, the administrative dossier, as well as the acute toxicity studies defined in subsections d.1.1, d.1.2, d.1.3, d.1.4, d.1.5, d.1.6, and the ecotoxicity studies defined in subsections d.5.1.1, d.5.3.1, d.5.4.1, of section 7.2.

Note that for cases where the manufacturer of the product has not changed, the challenged Decree only requires the application for the manufacturer update, the certificate of registration issued by the authority of the country of origin, the certificate of qualitative-quantitative composition, and proof of payment of the current fee.

For cases where the manufacturer of the product has changed, even though other requirements are demanded, these are still fewer than those set forth by Decree 33495. Furthermore, it allows the information from the technical dossier to be submitted via referenced information and requires acute toxicity studies only when the technical grade active ingredient contains relevant impurities at levels above recognized international standards, or which are listed in Annex III of the Rotterdam Convention, or in the Stockholm Convention, or in the Montreal Protocol.

That is, the revalidation process under Decree 33495 required certain technical requirements that have not been contemplated by Decree 39995, despite the fact that its own recitals (considerandos) recognize that it involves the updating of products that have not met the toxicological, ecotoxicological, and environmental fate information requirements established in international regulations and required since the entry into force of Decree 33495.” For her part, the director of the Directorate of Environmental Quality Management (Dirección de Gestión de Calidad Ambiental) of the Ministry of Environment and Energy (MINAE) stated the following:

“Executive Decree No. 39995-MAG was issued arbitrarily and unilaterally by the MAG with the aim of completing the files for old products, including the registration of the technical grade active ingredients (IAGT) that support these formulations (which, under previous regulations, did not have to be registered), as well as defining new validity periods for these old products. However, in an evident breach of the provisions of the CGR in report FOE-AM-19/2004, the participation of MINAE or the Ministry of Health was NOT contemplated, nor were the regulated parties required to submit all the studies required to carry out the environmental and health assessment, established in Executive Decree No. 33495-MAG-S-MINAE-MEIC and Executive Decree No. 40059-MAG-S-MINAE. Just as was established in Executive Decree No. 24997 and Law No. 8702, it was also not considered that the insufficient studies required in Decree 39995 be analyzed by the competent authority in environmental or health matters, which leads to these products continuing to be marketed without a ruling that guarantees the protection of the environment and human health.” (Emphasis added. Official communication DIGECA-516-2018 of December 19, 2018).

3.- Regarding the precautionary principle and the reversal of the burden of proof. This issue was covered in our dissenting vote (voto salvado) to judgment no. 2017-06668 of 10:50 a.m. on May 10, 2017, in the following terms:

“Dissenting vote of Magistrates Cruz Castro and Rueda Leal, authored by the latter. With the customary respect, we dissent from the majority opinion for the following reasons.

In his filing brief, the claimant explains that article 7 of the challenged Regulation contravenes the precautionary principle and reverses the burden of proof in environmental matters. He reaches this conclusion because the article in question obliges the competent ministries to ‘…demonstrate an unacceptable risk to human health, the environment, or agriculture…’ in order for the Sanitary Service (Servicio Sanitario) to restrict or prohibit the use of a registration.

In the judgment, the majority of this Court considered that the claim was not well-founded because the challenged rule actually protected the environment. In that sense, the resolution argues that the moment for applying the precautionary principle is during the processing of the registration application. Once the registration is approved, it will be necessary to demonstrate the unacceptable risk indicated by the rule.

As a starting point, it is necessary to recall what this Chamber has established regarding the precautionary principle in environmental matters:

“III.- Environmental risk prevention. This obligation of the State being established at the constitutional level, it is important to appreciate how, at the level of international instruments for the protection of human rights, specific obligations that must be respected are also established. In environmental matters, the duty of prevention that must exist in this area has been defined; the Rio Declaration, adopted at the United Nations Conference on Environment and Development, states that:

\"Principle 15.- In order to protect the environment, the precautionary approach shall be widely applied by States according to their capabilities. Where there are threats of serious or irreversible damage, lack of full scientific certainty shall not be used as a reason for postponing cost-effective measures to prevent environmental degradation\".

Prevention seeks to anticipate negative effects and ensure the protection, conservation, and adequate management of resources. Consequently, the guiding principle of prevention is based on the need to take and assume all precautionary measures to avoid or contain the possible impact on the environment or people's health. Thus, should a risk of serious or irreversible damage exist—or any doubt in this regard—a precautionary measure must be adopted, including postponing the activity in question. This is because, in environmental matters, after-the-fact coercion is ineffective, since if the damage has already occurred, the biologically and socially harmful consequences may be irreparable; the penalty may have moral significance but will hardly compensate for the damage caused to the environment.

As indicated by the international instrument cited, as well as Article 50 of the Constitution, the State is called upon to carry out this prevention work, and this Chamber has recognized this by stating, through judgment number 2001-6503 of July 6, two thousand one, that:

“The third paragraph of Article 50 of the Constitution clearly states that the State must guarantee, defend, and preserve the right of every person to a healthy and ecologically balanced environment; which implies affirming that public entities are not only obligated to ensure compliance—by individuals and other public entities—with environmental legislation, but also, above all, that they must adjust their actions to the dictates of those protective normative bodies. State institutions are the first called upon to comply with protective environmental legislation, without any justification existing to exempt them from complying with environmental requirements such as, for example, the environmental impact study required by the Organic Environmental Law (Ley Orgánica del Ambiente) for activities undertaken by public entities that, by their nature, may alter or destroy the environment.” (Judgment 2010-11941 of 11:21 a.m. on July 9, 2010) As can be seen from the transcript, the prevalence of the precautionary principle lies in the need to avoid serious and irreparable damage to the environment, obliging the adoption of measures that anticipate such damage. That is, given the possibility that an irreversible or serious danger may materialize, the State's duty to act arises, requiring for this merely the existence of a reasonable doubt of risk to the environment.

Now, contrary to what the majority defends, the precautionary principle is not limited to a single stage of the administrative procedure; rather, it constitutes one of the principles that must guide administrative action at all times.

We consider that the interpretation made by the Chamber could signify the creation of a presumption in favor of the registration and against the environment and human health. In this way, the State would be burdened with proving the existence of the aforementioned risk, in order to overcome such a presumption. But even more, proving the risk alone is not enough; the State must also prove, according to the majority, that said risk is unacceptable, which makes the possibility of acting in favor of the environment and human health even more difficult.

These requirements could be unreasonable and disproportionate, since months or years may elapse between the moment the reasonable doubt arises and the moment the existence of an unacceptable level of risk can be demonstrated. This time lapse could allow the risk to materialize and irreversibly or seriously harm the environment and human health. Thus, there could be a contradiction between the situation of *lege lata* and the aims of the precautionary principle, which clearly justifies granting the action.

The claimant may also be correct in criticizing the reversal of the burden of proof. In this case, the registration holder possesses all the technical information related to the product and, furthermore, is the interested party in maintaining its legal use in the country, which makes it reasonable to impose on them the burden of proving its harmlessness to the environment and human health.

We consider that all these issues should be analyzed more thoroughly by the full panel of this Chamber, granting a hearing to the Office of the Attorney General of the Republic (Procuraduría General de la República) and the competent authorities.

Furthermore, given the current environmental problems and the international consensus regarding the imminence of environmental issues threatening the entire human race (such as climate change, recognized in the Paris Agreement by 193 States), the undersigned are surprised that the majority of this Chamber advocates disregarding the precautionary principle and, instead, defends the imposition of qualified requirements on the Administration when it seeks to safeguard the environment and human health.

By virtue of the arguments presented, we dissent and order that the action be processed.” 4.- Regarding citizen participation.

In judgment no. 2021-25386 of 1:10 p.m. on November 10, 2021, we referred to citizen participation in the following terms:

“As stated in the dissenting vote to judgment no. 2017-1163 of 9:40 a.m. on January 27, 2017, we believe that it can be inferred from Article 9 of the Political Constitution that citizen participation, beyond a general principle, has been established as a true fundamental right in light of the conventional framework that accompanies and integrates our fundamental rights regime.

Precisely, in judgment no. 2013-017305 of 11:32 a.m. on December 20, 2013, this Constitutional Chamber (Sala Constitucional) considered that the right to citizen participation in decision-making has become one of the fundamental pillars upon which the democratic system rests. In our country, the constitutional legislator enshrined this right in Article 9 of the Political Constitution by providing that the Government of the Republic be popular, representative, participatory, alternative, and responsible (emphasis not in original), according to the reform introduced by Law No. 8364 of July 1, 2003, published in La Gaceta No. 146 of July 31, 2003. This mandate of the Fundamental Law, particularly the quality of 'participatory,' has guided subsequent constitutional and sub-constitutional normative development. Thus, a series of mechanisms have been established that seek to ensure that the right to participatory government can be applied efficiently and effectively, so that it does not remain merely a paper right; examples of this are the referendum for the approval or repeal of laws and partial reforms to the Constitution, or the popular initiative in the formation of laws (see, among others, judgment number 2005-05649 of 2:39 p.m. on May 11, 2005).

The right to participatory government not only embodies recognition of the highest positive-legal rank for the function of political control by the inhabitants of the Republic, but also signifies a revaluation of their role in the processes of formulation, application, and control of public policy. By will of the constituent legislator, which this Chamber must not and cannot ignore, the right to participatory government stands as a fundamental pillar of our democratic regime (an issue erroneously disregarded by the minority vote, which downgrades the category of citizen participation from a right to a general principle, in clear contradiction to the jurisprudential line of this Chamber, as demonstrated below), which is consistent with a political system based on tolerance, pluralism, and respect for freedom.

As we indicated above, this categorization of participatory government or citizen participation as a right is explained through the conventional support contained in various international human rights instruments.

Verbigratia, article 21 of the 1948 Universal Declaration of Human Rights provides that 'everyone has the right to take part in the government of his country, directly or through freely chosen representatives' (emphasis not in original).

Consistent with the above, Article 25 of the International Covenant on Civil and Political Rights expressly recognizes the right of citizens: '(…) to take part in the conduct of public affairs, directly or through freely chosen representatives'.

In the same vein, the Inter-American Democratic Charter states in its Article 5 that: 'Representative democracy is strengthened and deepened by permanent, ethical, and responsible participation of the citizenry within a legal framework conforming to the respective constitutional order'.

More forcefully, Article 6 of this Charter establishes that: 'It is the right and responsibility of all citizens to participate in decisions relating to their own development. This is also a necessary condition for the full and effective exercise of democracy. Promoting and fostering diverse forms of participation strengthens democracy'. (Emphasis not in original).

The United Nations Human Rights Council also recognized citizen participation as fundamental for the protection of the environment:

'Recognizing also that the exercise of human rights, including the freedom to seek, receive and impart information and to participate effectively in the conduct of government and public affairs and the right to an effective remedy, is fundamental for the protection of a clean, healthy, safe and sustainable environment,' (Human Rights Council, 46th session, A/HRC/RES/46/7 of March 23, 2021).

It is also important to highlight that, recently, the United Nations Human Rights Council, in resolution A/HRC/RES/48/13 of October 8, 2021, has come to grant the status of a human right to effective participation in environmental matters. In this regard, it stated:

'Recognizing that the exercise of human rights, including the rights to seek, receive and impart information and to participate effectively in the conduct of government and public affairs and in environmental decision-making, as well as the right to an effective remedy, is fundamental for the protection of a clean, healthy and sustainable environment.'. (Emphasis not in original).

For its part, in Advisory Opinion OC-23/17 of November 15, 2017, the Inter-American Court of Human Rights highlighted that:

'226. Public participation represents one of the fundamental pillars of instrumental or procedural rights, given that it is through participation that individuals exercise democratic control over state actions and can thus question, inquire into, and consider the fulfillment of public functions. In this sense, participation allows individuals to be part of the decision-making process and for their opinions to be heard. In particular, public participation enables communities to demand accountability from public authorities for decision-making and, at the same time, improves the efficiency and credibility of government processes. As mentioned on previous occasions, public participation requires the application of the principles of publicity and transparency and, above all, must be supported by access to information that allows social control through effective and responsible participation' (emphasis added).

A stance that had also been adopted in the judgment of September 19, 2006, concerning the case of 'Claude Reyes et al. vs. Chile', in which it was established:

'86. In this regard, the State’s actions must be governed by the principles of publicity and transparency in public administration, which enables persons subject to its jurisdiction to exercise democratic control over state actions, so that they can question, investigate, and consider whether public functions are being adequately performed. Access to State-held information of public interest can permit participation in public administration through the social control that can be exercised through such access. 87. Democratic control, exercised by society through public opinion, fosters transparency in State activities and promotes the accountability of public officials regarding their public management. Therefore, for individuals to exercise democratic control, it is essential that the State guarantees access to information of public interest under its control. By permitting the exercise of such democratic control, greater public participation in societal interests is fostered.'. (Emphasis added).

Thus, this conventional recognition of citizen participation hermeneutically impacts its legal nature, since it transforms it from a constitutional principle into a true collective fundamental right.

In this way, citizen participation represents an essential aspect of the democratic and republican model of this century, in which citizen control, transparency, and accountability stand out as expressive elements of this type of political regime, which in turn confers much greater legitimacy on political decision-making, a key issue when it comes to governance. Thus, within the framework of this type of regime —that is, with active and full citizen participation— participatory government has a greater impact, favoring decision-making through more open and transparent means.

Precisely, one of the mechanisms designed to fulfill the provisions of Article 9 of the Constitution is the public hearing (audiencia pública), through which interested persons can assert their rights or express their opinion, actively participating in issues of national or local relevance, and bringing to the Administration's attention all those anomalies or disagreements regarding a project to be developed.

Thus, the public hearing is a typical instrument of a republican democracy, through which citizen participation in the public decision-making process is fostered. Due to its significance, the hearing must be conducted in such a way as to guarantee the greatest possible participation of the individuals who may be affected; hence, any action or omission that hinders the foregoing constitutes an open violation of the constitutional right to citizen participation (see, among others, judgment number 2009-018223 of 12:34 p.m. on November 27, 2009).

Regarding the participatory nature of the public hearing, as indicated, Article 9 of the Political Constitution itself requires it, since the qualification 'participatory' established therein implies, among other aspects, that the Government must be an articulator of what is defined by popular deliberation, when this is mandatory, while in the formulation of public policy, within the possibilities that the current positive legal framework establishes, it is obliged to listen to the opinion of affected individuals or groups, whether this is binding or not.

In other words, in the current republican democracy, citizens enjoy, by constitutional mandate, not only the right to vote to exercise their right to participatory government, but also a quantity of instruments of diverse nature to assist in government decision-making and political control, which enables them to exert direct influence on major public decisions.

Within this context, it is worth highlighting that this Court, in judgment no. 2018004117 of 9:15 a.m. on March 13, 2018, elaborated on public consultation in environmental matters, emphasizing that this mechanism is a pillar in decision-making related to the environment. Likewise, as a form of soft law, it resorted to a particularly relevant instrument regarding access to environmental information and citizen participation: the 'Convention on Access to Information, Public Participation in Decision-making and Access to Justice in Environmental Matters', better known as the 'Aarhus Convention'. In this sense, the aforementioned ruling stated:

'The Aarhus Convention, for its part, in article 6.2.3.4 provides:

'2. When a decision-making process regarding the environment is initiated, the public concerned shall be informed effectively, as appropriate, in a timely manner, by public notice or individually, as the case may be, early in the process. The information shall relate, in particular, to:

• a)The proposed activity, including the corresponding application on which a decision will be made; b) The nature of possible decisions or the draft decision; c) The public authority responsible for making the decision; d) The envisaged procedure, in particular, when this information can be provided:
• i)The commencement of the procedure; ii) The opportunities for the public to participate; iii) The time and venue of any envisaged public hearing; iv) An indication of the public authority from which relevant information can be obtained and where the relevant information has been deposited for examination by the public; v) An indication of the public authority or any other official body to which comments or questions may be submitted and of the time schedule for transmittal of comments or questions; vi) An indication of what environmental information relevant to the proposed activity is available; and e) The fact that the activity is subject to a national or transboundary environmental impact assessment procedure.

3. The public participation procedures shall include reasonable time-frames for the different phases, allowing sufficient time for informing the public in accordance with paragraph 2 above and for the public to prepare and participate effectively during the environmental decision-making process.

4. Each Party shall provide for early public participation, when all options are open and effective public participation can take place.' In accordance with the foregoing, the consultation must be conducted transparently and with as much information as possible. This generates better management of natural resources, contributes to transparency, and the proper handling of public funds. Let us remember that the environmental issue concerns all members of society, not just the government, so it is also the duty of every citizen to ensure the conservation of the environment and seek sustainable development. This is why it must comprehensively encompass the different sectors of the population (…)' (Emphasis added).

In addition, in the aforementioned pronouncement, the Chamber stressed that the public hearing (audiencia ciudadana), being a manifestation of the democratic principle, should not become a simple formality that must simply be scheduled, although it should also not be used as a mere obstacle to the issuing of an administrative decision.

Related to the above, this Chamber has repeatedly stated that the Constitution is characterized by its supremacy and its direct and immediate efficacy, by virtue of which the rights and guarantees it confers are directly enforceable and binding on all Public Powers. Thus, in judgment no. 1992-3194 of 4:00 p.m. on October 27, 1992, it was pointed out:

'(…) The Political Constitution, in its unanimous contemporary conception, is not only 'supreme' as a criterion of validity for itself and the rest of the legal system, but also a set of fundamental, legally binding norms and principles, therefore, enforceable by themselves, against all public authorities, and even against private parties, without the need for other norms or acts that develop them or make them applicable—except for qualified exceptional cases, in which without them its application is impossible—; with the consequence that both administrative and jurisdictional authorities have the power-duty to directly apply the Law of the Constitution in its fullest sense, even in the absence of a lower-ranking norm or by disapplying those that oppose it.' For its part, in judgment no. 1995-1185 of 2:33 p.m. on March 2, 1995, this Court confirmed:

'If the Political Constitution has a supreme normative character, it must effectively shape and condition the validity and effectiveness of all inferior or subordinate norms, and it serves as a parameter for legitimizing or not the actions of any public authority and even of private subjects.... The principle of supremacy of the Constitution, in the Costa Rican case, is not only expressly enshrined in Article 10, but is very clearly complemented regarding the body responsible for maintaining or preserving it, as we will analyze below. What we have expressed so far revolves around the fact that the Constitution has direct efficacy and binds without the need for intermediation by any other norm. And it is for this reason that all authorities, in general, have the capacity and power to apply, develop, and expand the fundamental rights contained in the Political Constitution. If this were not the case, all the argumentation about the hierarchy of constitutional norms, principles, and values would collapse into an unsustainable fantasy. It would be mere science fiction, an entelechy, in which two legal worlds simultaneously exist, located on different planes and with no communication between them.' In conclusion, citizen participation constitutes a constitutional and conventional right, which stands as a quality of the republican democratic system. In this regard, the rights enshrined in the Fundamental Law, to varying degrees depending on whether their content is more or less programmatic, have direct efficacy and are binding without the need for any other norm. Moreover, their effectiveness through sub-constitutional normative development and its application is not exempt from jurisdictional control of constitutionality, when regulations, actions, or omissions representing a violation of the core (Kernbereich) of that constitutional good are observed.” In the case at hand, we believe that the challenged decree violates the right to citizen participation in matters of utmost importance to the population, such as the environment and public health. The relevance of citizen participation in this area is recognized in the already cited 'International Code of Conduct on the Distribution and Use of Pesticides. Guidelines for the Registration of Pesticides,' whose point 3 (The principles of pesticide registration) states:

'Governments should facilitate the exchange of information among responsible authorities through national institutions, international, regional and sub-regional organizations as well as public sector groups.' They should develop legislation and regulations to permit the exchange of information with the public on the risks and benefits of pesticides, and also to facilitate public participation in the country's pesticide management." (Emphasis added). Citizen participation is also included in its point 10 (Coordination and collaboration): "10.1.3 Regulated community There should be periodic dialogues between the responsible authority and the regulated community, including the pesticide industry, pesticide vendors, professional pest control operators, pesticide advertising agencies, and the general public, so that they receive feedback and suggestions on the implementation and application of pesticide registration in the country. The responsible authority should encourage the pesticide industry to develop low-risk pesticide products as well as product stewardship activities. 10.1.4 Civil society The responsible authority may have a frequent dialogue with civil society representatives to address issues related to pesticide registration in the country. Civil society groups may be particularly important in providing feedback on the use of pesticides, and on the real and potential problems that may occur." (Emphasis added)." Additionally, with respect to the specific case, we set forth the following defects that warrant declaring the unconstitutionality of the decree.

Regarding the reduction of requirements for the approval of the validation, we determine that article 1 does not require acute toxicity and ecotoxicity studies, as decree 33495 did. Furthermore, article 1.1 eliminated the request for the manufacturer update, the registration certificate issued by the authority of the country of origin, and the endorsement of a chemist for the qualitative-quantitative composition certificate. Article 1.2 eliminated the registration certificate issued by the authority of the country of origin.

Likewise, regarding the use of referenced information, we adopt the clarifications of the Procuraduría General de la República:

"…although the Procuraduría is not a technical body in the matter, it can be stated that even though the challenged Decree modifies articles 1.2.b and 6 of Decree 39995 which allowed registering products through referenced information, it maintains that possibility, since article 1.2.c permits the use of international specifications to certify that the technical material to be updated does not contain relevant impurities, stating in Considerando V that international specifications and standards are a technical and scientific reference to determine that the active ingredient technical grade does not contain relevant impurities at levels higher than the international standards or specifications, and that only those relevant impurities have toxicological or ecotoxicological relevance that may cause an impact on health or the environment.

In that same sense, article 3 provides that formulated pesticides that do not have an associated active ingredient technical grade registration will be granted that registration directly when the manufacturer of that active ingredient has been updated; article 6 provides that once the requirements are met, the registration will be granted for ten years and that, during that term, the SFE will verify that the already approved registrations of active ingredient technical grade have chemical equivalence with the reference profile of that active ingredient and that, in the absence of that profile, it must be verified that they do not contain relevant impurities; and article 11 endorses the homologation of labels and pamphlets with those of other already registered products that have the same active ingredient and the same concentration, without considering the effects that the other components of the product or the form or method of preparation could have.

The challenged regulation does not establish how the information will be verifiable, how to determine which international specification may be used, the method for determining the equivalence of products, nor whether the reference profile to be used must be a registration that has complete information, and therefore, that covers acute toxicity, ecotoxicity, chronic toxicology, ecotoxicological studies, and other studies on the abiotic environment as required by article 5 of the Ley para la Importación y Control de la Calidad de Agroquímicos and the Manual on Development and Use of FAO and WHO Specifications for Pesticides.

Hence, as indicated in the previous report, by not precisely establishing the rules to which the competent authority must adhere to verify the information, it is possible that the updating of registrations with referenced information that does not meet the indicated requirements is permitted, and, therefore, that would entail the updating of product registrations without a prior assessment of the environmental and health risks of their application." Pursuant to the foregoing, we determine that the challenged decree contravenes the constitutional framework and injures the right to a healthy and ecologically balanced environment. Therefore, we dissent and declare the action with merit.

Fernando Cruz C. Paul Rueda L.

Res. nro. 2023002389 Note from Judge Rueda Leal. As I have expressed in other cases, I consider that a quality of diffuse interests consists precisely in the fact that their impact is general —that is, it affects an entire population or broad sectors thereof— within a context where it is not required that the affected subjects know each other (they could even lack nexus or legal relationships among them), but the presence of the same situation of damage or danger to a constitutional right is required, which, equally and without any need for individualization, encompasses and agglomerates an entire society in abstract. Its defense has the purpose of satisfying a need of society as such, therefore, it transcends that of a human being individually or collectively considered. In judgment no. 2019-17397 at 12:54 hours on September 11, 2019, this Court reiterated the following:

"(…) Secondly, the possibility of resorting in defense of 'diffuse interests' is provided for; this concept, whose content has been gradually delineated by this Chamber, could be summarized in the terms used in judgment number 3750-93 of this court, at fifteen hours on July thirtieth, nineteen ninety-three) '… Diffuse interests, although difficult to define and more difficult to identify, cannot be in our law —as this Chamber has already stated— merely collective interests; nor so diffuse that their ownership merges with that of the national community as a whole, nor so concrete that identified or easily identifiable determined persons, or personalized groups, stand out before them, whose legitimacy would derive, not from diffuse interests, but from corporate interests that concern a community as a whole. It is therefore a matter of individual interests, but at the same time, diluted in more or less extensive and amorphous groups of people who share an interest and, therefore, suffer a harm, actual or potential, more or less equal for all, which is why it is rightly said that it involves equal interests of the groups that find themselves in certain circumstances and, at the same time, of each one of them. That is, diffuse interests partake of a dual nature, since they are at once collective —by being common to a generality— and individual, which is why they can be claimed in such character'.

In summary, diffuse interests are those whose ownership belongs to groups of people not formally organized, but united based on a particular social need, a physical characteristic, their ethnic origin, a certain personal or ideological orientation, the consumption of a certain product, etc. The interest, in these cases, is blurred, diluted (diffuse) among an unidentified plurality of subjects. In these cases, of course, the challenge that a member of one of these sectors could make under paragraph 2 of article 75 must necessarily refer to provisions that affect him or her as such. This Chamber has enumerated various rights to which it has given the qualifier of 'diffuse', such as the environment, cultural heritage, the defense of the territorial integrity of the country, and the sound management of public spending, among others. In this regard, two clarifications must be made: on one hand, the referred goods transcend the sphere traditionally recognized for diffuse interests, since they refer in principle to aspects that affect the national collectivity and not particular groups thereof; environmental damage does not only affect the residents of a region or the consumers of a product, but injures or puts at serious risk the natural heritage of the entire country and even of Humanity; likewise, the defense of the sound management of public funds authorized in the Presupuesto de la República is an interest of all the inhabitants of Costa Rica, not just of any single group of them. On the other hand, the enumeration made by the Constitutional Chamber is no more than a simple description proper to its obligation —as a jurisdictional body— to limit itself to hearing the cases submitted to it, without it being in any way understood that only those rights that the Chamber has expressly recognized as such can be considered diffuse rights; the foregoing would imply an undesirable overturning of the scope of the Rule of Law, and of its correlative 'State of rights', which —as in the case of the Costa Rican model— starts from the premise that what must be express are the limits on freedoms, since these underlie the human condition itself and therefore do not require official recognition. Finally, when paragraph 2 of article 75 of the Ley de la Jurisdicción Constitucional speaks of interests 'that concern the collectivity as a whole', it refers to the legal goods explained in the preceding lines, that is, those whose ownership rests in the very holders of sovereignty, in each of the inhabitants of the Republic.

It is not, therefore, a matter of any person being able to come to the Constitutional Chamber in protection of any interests (actio popularis), but rather that every individual may act in defense of those goods that affect the entire national collectivity, nor is any attempt at an exhaustive enumeration valid in this field either" (see judgment No. 2007- 01145)." In line with what has been stated and sustained by this Court in its jurisprudence, it is therefore a matter of individual interests, but at the same time, diluted in more or less extensive and amorphous groups of people who share an interest and, therefore, suffer a harm, actual or potential, more or less equal for all, which is why it is rightly said that it involves equal interests of the groups that find themselves in certain circumstances and, at the same time, of each one of them. It is for this reason, precisely, that, as of judgment no. 2021-2185 at 12:51 hours on February 3, 2021, I consider, unlike the Majority of this Court, that some of these interests may be embodied in a specific particular case, without thereby losing their condition as a diffuse interest, as occurs with the protection of the environment, whose impact affects one person and everyone in general; and such impact can be individualized in a particular situation, such as, for example, the construction of a factory in a specific neighboring sector, without the respective environmental studies, whose negative effects impact the planet's ozone layer. Undoubtedly, the result of a claim or proceeding that a neighbor may bring against that factory will not only affect their own interests, but also those of the rest of the community. Therefore, it constitutes a diffuse interest; and, nonetheless, it is also the object of an individualized particular situation. Now, this does not mean, in any way, that in every invoked situation the existence of a diffuse interest can be alleged, even though it may be the object of a particular situation. We must remember that for an interest to be considered "diffuse", it must not only affect a collectivity, but must also become blurred, diffused within that collectivity. If it does not produce such effect, it cannot be considered a diffuse interest. In this case, the diffuse interest alleged by the plaintiffs is the protection of the environment. For this reason and based on the clarifications just made, I hear the case on its merits.

Paul Rueda L.

Res. N° 2023-002389 NOTE FROM JUDGE CRUZ CASTRO.- The importance of protecting the right to the environment, to health, and to food safety, and in application of the constitutional environmental principles of progressivity and non-regression, the precautionary principle, the preventive principle, the in dubio pro natura principle, and the principle of objectification in the matter of pesticide regulation.

As I have considered in other cases where the issue of pesticides has come before this Chamber for discussion, it is relevant to start from the jurisprudential precedent judgment no. 2011-016937 at 14:36 hours on December 7, 2011: (https://nexuspj.poder-judicial.go.cr/document/sen-1-0007-532977). Here the Chamber outlined the constitutional framework under which a regulation for the registration, use, and control of pesticides must be analyzed, when the unconstitutionality action filed against Decreto Ejecutivo number 33495-MAG-S-MINAE-MEIC of October 31, 2006 indicated the following:

VI.- FOOD SAFETY, TRACEABILITY OR TRACKING, AND THE APPLICATION OF THE PRECAUTIONARY PRINCIPLE. This Chamber, in resolution 13924-2011 at 17:59 hours on May 10, referred to the topic of agri-food safety: "The right to food has been incorporated into most legal systems as a human right, now recognized in International Treaties and even elevated to constitutional rank in many countries. Agri-food law must be understood as the set of special rules, systematically ordered, that regulate the agri-food product and its production chain in all its phases, from production to consumption, controlling the stages of the agri-food enterprise and its productive activity for the purpose of guaranteeing the consumption of healthy and innocuous food products, in order to protect the health of persons, animals, and plants, or, to ensure the food supply of the population. From the above definition derives the need for the interpreter to contribute to the formulation and systematization of those special rules, in order to establish, within the framework of a general theory of agri-food law, what is the object, the subjects, the possible normative sources, the activities, and general principles that should guide the discipline. Quality and health requirements impose in turn traceability or tracking requirements for the product throughout the entire agri-food chain. The different fields of activity incorporate the global approach 'from farm to table', which characterizes this policy and consolidates the indivisible character of the food chain, and focuses on the decisive role played by the Servicio Nacional de Salud Animal. The conditions of any traceability system are: 1. At all stages of the chain, the health of the food must be ensured; 2. Agri-food enterprises must be able to identify any subject in the chain; 3. Enterprises must establish procedures and methods necessary for this; 4. Systems and procedures must be put into practice to be able to identify the products delivered; 5. Marketed foods must be identified for purposes of determining their provenance. The need to find a balance between food safety protection mechanisms with preventive purposes —precautionary principle— and the guarantee of the free circulation of agri-food products that meet international scientific standards is evident. The foregoing produces as a requirement the 'monitoring' of agricultural and food products, that is, traceability throughout the chain, in order to determine the eventual responsibility that may correspond to the agricultural producer or to the enterprise that transforms the products into food, including at each phase of the chain." Furthermore, the Ley de Protección Fitosanitaria, No. 7664 of April 8, 1997, also incorporates rules to avoid and prevent the introduction and spread of pests that threaten food safety and economic activity sustained in agricultural production, preventing such measures from constituting an unnecessary obstacle to free trade (article 2). For that reason, control mechanisms are established for the establishment, registration, and inscription of inputs for agricultural use, even establishing rules of agri-environmental responsibility when damages and losses to agriculture, the environment, and human and animal health occur (Chapter IV). Within this context, the use of agrochemicals acquires particular relevance for the exercise of agricultural productive activity, a subject on which there are multiple regulations at the national, regional, and international normative level (article 47). Precisely because its regulation is fundamental, within the framework of the agricultural competitiveness of producers on a global scale. In that context, national laws are enacted that introduce, or at least seek to introduce, integrated systems of agri-food and agri-environmental control, to guarantee the safety of people, the environment, and plants and animals, and even to avoid excessive contamination of water resources. Without a doubt, the rational use of synthetic pesticides for agricultural use promotes the competitiveness of the agricultural sector, and that is why the regulation is inspired by the creation of a balanced and modern registration system. It is a clear example of the effort to give completeness and organicity to a large number of rules scattered throughout the legal system, to respond to the demands of specialized international regulations, emanating both from the World Trade Organization and from Specialized Organizations, from FAO, and from WHO, closely linked with the Codex Alimentarius, and with International Environmental Conventions. That is why the Decree is issued jointly by the Presidency, and the Ministers of Agriculture, Health, Environment and Energy, and Economy, Industry and Commerce. It is evident that the phenomenon links the entire agricultural production process, and even the entire prior phase of production, registration, control, and inspection of pesticides for use in the agro-productive chain.

VII.- ON THE REDUCTION OF RISKS TO HEALTH AND THE ENVIRONMENT, PURSUANT TO ARTICLE 5 OF THE INTERNATIONAL CODE OF CONDUCT ON THE DISTRIBUTION AND USE OF PESTICIDES. It is pertinent to refer to the provisions of the cited International Code of Conduct on the Distribution and Use of Pesticides, which was adopted, for the first time in 1985, by the twenty-fifth session of the Conference of the Food and Agriculture Organization of the United Nations (FAO). As explained in the preface to the revised version (adopted by the 123rd session of the FAO Council, November 2002), said code of conduct was adopted and has been revised with the purpose of achieving greater food safety and, at the same time, protecting human health and the environment. For such purposes, standards of conduct are established that are to serve as a framework and reference point for the proper and rational use of pesticides, focusing on risk reduction, the protection of human and environmental health, and support for the development of sustainable agriculture through the effective use of pesticides [source: (Source: http://www.fao.org/agriculture/crops/core-themes/theme/pests/pm/code/en/(05/08/11)]. In this context, said code of conduct establishes, in its article 5, the following obligations for governments and the pesticide industry:

"Article 5. Reducing health and environmental risks 5.1 Governments should:

5.1.1 implement a pesticide registration and control system as set out in Article 6; 5.1.2 periodically review the pesticides marketed in their country, their acceptable uses and their availability to each sector of the public, and conduct special reviews when scientific evidence so advises; 5.1.3 carry out a health monitoring program for persons occupationally exposed to pesticides, and investigate and document poisoning cases; 5.1.4 provide guidance and instructions to health personnel, physicians, and hospital staff for the treatment of suspected cases of pesticide poisoning (25); 5.1.5 establish at strategic locations national or regional pesticide poisoning information and control centers capable of providing immediate guidance on first aid and medical treatment, accessible at all times (25); 5.1.6 use all possible means to collect reliable data and maintain statistics on the health aspects of pesticides and pesticide poisoning incidents, with the aim of establishing the harmonized system of the WHO for the identification and recording of such data (25). They should have adequately trained personnel and sufficient resources to ensure that accurate information is collected; 5.1.7 provide extension and advisory services, as well as farmers' organizations, with adequate information on practical IPM strategies and methods, and on the range of pesticide products available for use; 5.1.8 ensure, with the cooperation of the pesticide industry, that where pesticides are distributed through the same channels as food, clothing, medicines, and other products for consumption or topical application, such pesticides are physically separated from other goods to prevent contamination and/or mistaken identity. Furthermore, where appropriate, they should be clearly marked as hazardous materials. Every effort should be made to disseminate information on the dangers of storing food and pesticides together (26); 5.1.9 use all possible means to collect reliable data, maintain statistics on environmental contamination, and report specific incidents related to pesticides; 5.1.10 implement a program to monitor pesticide residues in food and the environment.

5.2 Even where a control program is in operation, the pesticide industry should:

5.2.1 cooperate in the periodic reassessment of the pesticides that are marketed; <![if ¡supportLists]>2. <![endif]> provide pesticide poisoning treatment centers and their medical staff with information on pesticide hazards and on appropriate treatment; 5.2.3 make every reasonable effort to reduce the risks posed by pesticides:

5.2.3.1 making less toxic formulations available; 5.2.3.2 introducing products in ready-to-use packages; 5.2.3.3 developing application methods and equipment that minimize exposure to pesticides; 5.2.3.4 using returnable and refillable containers when effective container collection systems exist; 5.2.3.5 using containers that are not attractive or easily reused and promoting programs that discourage reuse, where effective collection systems do not exist; 5.2.3.6 using containers that are not attractive to or easily opened by children, particularly for domestic use products; 5.2.3.7 using clear and concise labeling; <![if ¡supportLists]>4. <![endif]> halt sale and withdraw products when their handling or use poses an unacceptable risk under any directions for use or restrictions.

5.3 Governments and the industry should further cooperate in reducing risks by:

5.3.1 promoting the use of proper and affordable personal protective equipment (5); 5.3.2 making provisions for the safe storage of pesticides at both warehouse and farm levels (26, 27); 5.3.3 establishing services for the collection and safe disposal of used containers and small quantities of unused pesticides (28); 5.3.4 protecting biodiversity and minimizing the adverse effects of pesticides on the environment (water, soil and air) and on non-target organisms.

5.4 To avoid cases of confusion and unjustified alarm among the public, the interested parties should consider all available data and promote responsible disclosure of information on pesticides and their uses.

5.5 When establishing production facilities in developing countries, manufacturers and governments should cooperate to:

5.5.1 adopt engineering standards and follow practices appropriate to the nature of the manufacturing operations and the consequent hazards, and ensure the availability of appropriate protective equipment; 5.5.2 take all necessary precautions to protect workers, bystanders, surrounding communities, and the environment; 5.5.3 ensure proper siting of manufacturing and formulation plants and adequate control of their wastes and effluents; 5.5.4 maintain quality assurance procedures to ensure compliance with pertinent standards of purity, performance, stability, and safety." VIII.- ON THE REGULATION OF PESTICIDE REGISTRATION. The proper use of pesticides can be useful for the control and elimination of pests, to the benefit of the population's food safety and economic activity sustained in agricultural production. However, the potential risk to human health and the environment from the use of such substances must be recognized. This has even motivated the adoption of international instruments with the express objective of protecting human health —including the health of consumers and workers— and the environment from the possible harmful effects of pesticides, as is the case of the Rotterdam Convention on the Prior Informed Consent Procedure for Certain Hazardous Chemicals and Pesticides in International Trade, which was approved by Costa Rica through Law No. 8705 of February 13, 2009. In which case, in response to the mandatory legislative constitutionality consultation brought before this Court (file number 08-015252-0007-CO), prior to the approval of said international instrument, this Court stated —in what is relevant— that:

"(…) the Costa Rican State has the duty to act effectively and in advance, to avoid the occurrence of events that degrade the environment and compromise its sustainability. From that perspective, that it commits itself, through an international treaty such as the one consulted, or through an internal act, to facilitate the rational use of chemically hazardous products subject to international trade, is not only possible, but totally consistent with its constitutional duties. Pesticides and industrial chemical products are substances that can cause harm to human health and the environment. Faced with such a threat, the Rotterdam Convention provides the Parties the possibility to know in advance the composition and effects of certain chemical products, which are expressly indicated in its Annex III. The appropriate measures the State takes to regulate the commercialization and use of said products in industrial activities, agriculture, etc., are consistent with its duty to preserve the aforementioned values of constitutional rank. Hence, the duties that the State would assume in the event of definitively approving this Convention are legitimate, in accordance with Constitutional Law.

It would be a sovereign decision of the State to submit to the obligations contained in the Convention, to contribute to the protection of people's health and the integrity of the environment, so it can be concluded that, in general terms, no defects of unconstitutionality are observed in the clauses of the Rotterdam Convention, the approval of which is submitted for consultation.” (resolution number 2008-018207 of 18:15 hours on December 10, 2008) Thus, it is verified that this Tribunal has recognized the risk that the use of pesticides may entail and the importance of adopting suitable measures to regulate their use. In the Costa Rican legal system, there is diverse legal and regulatory normativity from which it follows that the activity of importing, manufacturing, marketing, and using pesticides is heavily subject to the police power (potestad de policía) of the State, in order to guarantee the right to health and to a healthy and ecologically balanced environment. One can cite, first, the General Health Law (Ley General de Salud), which in its Article 213 provides:

“ARTICLE 213.- Any natural or legal person engaged in producing food must do so under sanitary environmental conditions and using defense or conservation techniques approved by the health authority, in order to avoid, mainly, the contamination of such products and their dangerousness due to the presence of toxic residues coming from their treatment with pesticides or other defense or conservation systems.” While Article 244 of that same normative body establishes:

“ARTICLE 244.- Natural and legal persons that import, manufacture, handle, store, transport, trade, supply, or apply substances, mixtures of substances, or products called pesticides by the Plant Health Law (ley de sanidad vegetal) shall be subject to the regulatory provisions that the Ministry dictates by mutual agreement with the Ministry of Agriculture for the protection of people's health in accordance with that law; interested parties must register every pesticide or product intended for the control or extermination of infestations and request prior permission to operate when such substances, mixtures of substances, or products that by their nature or use are not included in the mentioned law are capable in any way of producing poisoning or serious damage to the health of people or of useful or harmless animals to man.” For its part, through the Phytosanitary Protection Law (Ley de Protección Fitosanitaria) (Law No. 7664 of April 8, 1997), the phytosanitary protection measures established in that law and its regulations were declared of public interest and mandatory application (Art. 1). Furthermore, among the objectives of said law is included: “To regulate the use and handling of chemical, biological, or related substances and equipment to apply them in agriculture; also, their registration, importation, quality, and residues, while seeking to protect human health and the environment” (Article 2, subparagraph E). The competent authority on the matter is the State Phytosanitary Service (Servicio Fitosanitario del Estado, SFE), which is responsible—among other functions—for: “Controlling chemical, biological, or related substances for agricultural use, with regard to their registration, importation, exportation, quality, tolerance, residues, dosages, effectiveness, toxicity, presentation to the public, conservation, management, trade, general conditions of use, safety, and precautions in transport, storage, disposal of containers and residues of such substances; likewise, controlling the equipment necessary to apply them and any other activity inherent to this matter” (Article 5, subsec. O). In accordance with the above, Articles 23, 24, 25, and 30 of said normative body provide:

“ARTICLE 23.- Registration of substances and equipment.

According to the requirements to be specified in the regulation of this law, all chemical, biological, or related substances and application equipment for agricultural use must be registered in the registry that the State Phytosanitary Service (Servicio Fitosanitario del Estado) will create to have information on their characteristics and to ensure their correct use in the country.” “ARTICLE 24.- Registry of substances.

No natural or legal person may import, export, manufacture, formulate, store, distribute, transport, repackage, refill, advertise, handle, mix, sell, or use chemical, biological, or related substances for agricultural use that are not registered in accordance with this law.

Excepted from the indicated registration are chemical, biological, or related substances for agricultural use that enter in transit, for research, or for combating specific phytosanitary problems. In these cases, the permit will only be granted temporarily for reasons of urgency, technically justified before the State Phytosanitary Service.

The Service will deny authorization when it is technically inapplicable and will notify the interested party.” “ARTICLE 25.- Registration of persons.

Any natural or legal person that registers, imports, exports, repackages, and refills chemical, biological, or related substances and application equipment for agricultural use must register in the registry to be kept by the State Phytosanitary Service, upon prior compliance with the requirements indicated in the respective regulation.

The Service may deny, suspend, or cancel the registration of chemical, biological, or related substances and application equipment for agricultural use, through a reasoned technical resolution that conforms to due process, according to the respective regulation.” “ARTICLE 30.- Prohibitions and restrictions for technical reasons.

The Ministry of Agriculture and Livestock (Ministerio de Agricultura y Ganadería) may restrict or prohibit the importation, transit, re-routing, manufacture, formulation, refilling, repackaging, storage, sale, mixing, and use of chemical, biological, or related substances and application equipment for agricultural use, when justified for technical reasons and their use is considered harmful to agriculture, health, or the environment.” Finally, the Law for the Importation and Quality Control of Agrochemicals (Ley para la Importación y Control de la Calidad de Agroquímicos) (Law No. 7017 of December 17, 1985) states, in its Article 5, that:

“ARTICLE 5.- For the purpose of ensuring the quality and use of agrochemicals, the Ministry of Agriculture and Livestock is obliged to carry out periodic quality controls on these products in factories and distribution houses, where it shall take the necessary samples to send them to the quality control laboratory. This Ministry shall also be responsible for controlling chronic toxicity and its effect on people's health and the environment. No product may be registered without having undergone these analyses. The Ministry of Agriculture and Livestock may prohibit the circulation or order the destruction of products that do not comply with quality standards, as well as take other measures aimed at improving the quality of agrochemicals. Regarding the elaboration and control of quality standards, the said Ministry shall act in coordination with the National Office of Standards and Units of Measurement (Oficina Nacional de Normas y Unidades de Medidas) of the Ministry of Economy and Commerce (Ministerio de Economía y Comercio).” It follows from the previously cited normativity that, as a manifestation of the aforementioned police power, the necessary registration of pesticides prior to authorizing their importation, manufacture, commercialization, or use is included, in order to be able to exercise prior control regarding the due compliance with the corresponding technical quality and safety requirements, in protection of public health and the environment.” From all of which the following main ideas are extracted that serve as the basis for this note:

*The right to food as a human right imposes food security and thereby requires the traceability or trackability (trazabilidad o rastreabilidad) of the product throughout the entire food chain (“from farm to fork”). For this reason, control mechanisms are established for establishments, registration, and enrollment of inputs for agricultural use, even establishing agro-environmental liability standards when damages and losses occur to agriculture, the environment, and human and animal health.

*Integrated agri-food and agro-environmental control systems are therefore established to guarantee the safety of people, the environment, and plants and animals, and even to avoid excessive contamination of water resources.

*According to the International Code of Conduct on the Distribution and Use of Pesticides, which was first adopted in 1985, by the twenty-fifth session of the conference of the United Nations Food and Agriculture Organization (FAO), standards of conduct are established that are to serve as a framework and point of reference for the adequate and rational use of pesticides, which focus on risk reduction, the protection of human health and the environment, and support for the development of sustainable agriculture through the effective use of pesticides. Furthermore, see the Rotterdam Convention on the Prior Informed Consent Procedure for Certain Hazardous Chemicals and Pesticides in International Trade, which was approved by Costa Rica, through Law No. 8705 of February 13, 2009.

*The use of pesticides, while it may be useful for the control and elimination of pests, for the benefit of the population's food security and the economic activity sustained in agricultural production. Also, the potential risk that the use of such substances may pose to human health and the environment must be recognized. Therefore, as a manifestation of the State's police power, the necessary registration of pesticides is included prior to authorizing their importation, manufacture, commercialization, or use, in order to be able to exercise prior control regarding the due compliance with the corresponding technical quality and safety requirements, in protection of public health and the environment.

Furthermore, one must remember the constitutional jurisprudence on the principle of progressivity and the principle of non-regression in environmental matters.- The principle of progressivity imposes on the State the obligation to gradually increase, to the extent of its possibilities and development, the level of protection of the right to the environment. It is the obligation to progressively develop and execute policies and norms aimed at achieving the full effectiveness of the right to the environment. The principle of non-regression stands as a substantive guarantee of the right to a healthy and ecologically balanced environment, by virtue of which the State is obliged not to adopt measures, policies, or approve legal norms that worsen the situation of the rights achieved up to that point (see vote 2016-00415). In this case, it is verified that the decree repealed by the decree in question was much more adequate, complete, and rigorous for the entry and control of pesticides. This confirms the regressivity in this matter. Comparing the regulation made by the challenged decree with the previous regulation, the regressivity is evident and with it, furthermore, the non-progressivity in the protection of health and the environment in matters of regulation of the registration and use of pesticides in our country.

Serious danger to the environment and public health: The great concern that has been expressed about the quality of pesticides that could be released into agricultural fields and the environment is alarming, given that, first, the IAGTs are registered by equivalence or revalidated, without the technical information necessary for a health and environment risk assessment, which contravenes the OECD recommendations (which establish the need to carry out a risk assessment prior to the registration of chemical substances, such as pesticides); and second, by not requiring the submission of biological tests for the registration of formulated products containing the unevaluated IAGTs, a lack of knowledge of the effects on human beings and the environment can be inferred, as well as an uncertainty as to whether the product fulfills its pest control function.

Transcendence of the issue in question for human health: The significance of the issue addressed must be remembered, as pesticides have a direct impact on human health. The agrochemical and biological substances used in agriculture can represent damage—or a risk of infringement—. These agrochemicals reach the cultivated foods directly, and then, the tables of all consumers. In such a way that agricultural inputs, particularly pesticides, are likely to cause irreparable damage to the environment and health, especially if used incorrectly, which is why the State must issue the norms and adopt the necessary measures so that all activity related to agrochemical products, particularly pesticides, is in accordance with the duty to preserve health and the environment. As mentioned by the petitioner, the Human Rights Council of the United Nations General Assembly, through resolution 34/12 (A/HRC/RES/34/12), indicated regarding the right to food, approved on March 23, 2017, in its point 41, “Invites States to promote practices that minimize the potential risks to health and the environment related to pesticides, while ensuring their effective use”. Furthermore, Article 5 “Reducing health and environmental risks” of the International Code of Conduct on Pesticide Management, of the FAO and WHO, establishes that governments should implement a pesticide registration and control policy and system in accordance with Article 6, which they transcribe, indicating policies and legislation, establishing systems and infrastructures so that each pesticide product is registered before it is available, risk assessments and adopting risk management decisions, and applying the principles described in the Manual on the development and use of FAO and WHO specifications for phytosanitary products, for the purpose of determining equivalence between pesticides.

Violation of the preventive principle, precautionary principle, pro natura principle, and principle of objectification of environmental protection (objetivación de la tutela ambiental): The challenged normativity is contrary to what the constitutional principles on environmental matters command: preventive principle (when there is certainty of possible damage to the environment, the affecting activity must be prohibited, limited, or conditioned upon compliance with certain requirements. In general, this principle applies when there are clearly defined risks identified at least as probable; likewise, this principle is useful when there are no technical reports or administrative permits that guarantee the sustainability of an activity, but there are sufficient elements to foresee eventual negative impacts), precautionary principle (when there is danger of serious and irreversible damage, the lack of absolute scientific certainty shall not be used as a reason to postpone the adoption of cost-effective measures to prevent environmental degradation. The principle starts from a reasonable scientific uncertainty together with the threat of serious and irreversible environmental damage), pro natura principle (in case of doubt or uncertainty, controversies must be resolved and norms must be interpreted in favor of the protection and conservation of the environment), and the principle of objectification of environmental protection (or principle of linkage to science and technique, according to which it is required to substantiate decision-making in this matter with technical studies, both in relation to acts and provisions of a general nature—both legal and regulatory—, from which the requirement of “linkage to science and technique” is derived, with which, the Administration's discretion in this matter is conditioned. It has been defined as principle number 17 of the Rio Declaration on Environment and Development). When faced with a situation that requires the application of the precautionary principle, public entities and bodies must refrain from authorizing, approving, or permitting any new or modification application that reasonably implies a serious risk; they are even obliged to suspend ongoing activities, likewise, in parallel, they have to efficiently adopt all necessary measures for the preservation of a healthy and ecologically balanced environment. Therefore, the application of the precautionary principle implies that when there are indicators that a certain activity could plausibly cause serious and irreversible damage to the environment, the lack of absolute certainty or scientific evidence in this regard does not exempt from the obligation to adopt all those efficient and effective measures to prevent an infringement on the environment. Furthermore, in consideration of the theory of Drittwirkung der Grundrechte, this principle extends its guiding function to the conduct of subjects of law, both public and private.

The foregoing is violated by the decree in question. Thus, to further highlight the importance of protecting the right to the environment, to health, and to food security, and in application of the constitutional environmental principles of progressivity and non-regression, precautionary principle, preventive principle, principle in dubio pro natura, and principle of objectification, I have considered it appropriate to record this note in the terms expressed.

Fernando Cruz Castro 1 The evaluating officials of registered information, in fulfillment of this constitutional responsibility, are obligated to request, through technical reasoning, the information they need to ensure that the pesticide does not have negative externalities for health and the environment. In the article in question, the MAG again insists on the referenced information process, as it tacitly indicated in Decree No. 39995-MAG, which is practically repealed with the publication of this new decree, which indicates the following:

“In the event that an international specification exists for the technical grade active ingredient subject to updating, it must be provided by the applicant in order to prove that the technical material being submitted to the updating process does not contain relevant impurities at levels higher than recognized international standards; the only international information that can be provided is referenced information from another product.” Without proprietary or referenced information as proposed by this regulation, what the Executive Branch and the pesticide industry seek is to facilitate the trade of pesticides against human and animal health and the environment. Thus, it is proposed to evaluate a pesticide whose information and chemical and physical characteristics belong to another product that is available as general information on the internet, which has no relationship whatsoever with the product to be revalidated or registered. If they refer to the same active ingredient, the minimum that can be done in accordance with national and international standards is the chemical equivalence study.

Regarding Art. 2 The proposed reform reduces the time for evaluators to make a decision, going from three months defined in Executive Decree No. 39995 to one month in the modification proposed in Decree No. 41481-MAG. It is evident in this type of regulation that what is sought is the benefit of agrochemical selling companies, so that registration analysts carry out the analysis under time pressure, without any evidence of a workload study to determine the proposed time. But what is most serious is that said analysis proposed in this decree is defined as a simple verification of chemical documents; that is, whether the registrants submitted the information or not. However, the degree of lack of coordination is such that this verification of documents of a chemical nature is assigned to agronomy professionals, who lack the competencies or training to perform this task. This proposal constitutes a new registration modality carried out only with a simple “checklist.” Regarding Art. 3 Once again, the ministerial office shortens the time established in Executive Decree No. 39995 for the benefit of users, without it being known if there is a technical workload study to support such a decision to go from three months to ten days for the technical evaluation by SFE officials. This is because this decree unilaterally exempts the corresponding ministries from participation in health and environmental matters. The prioritization of the ministerial office is once again evident, which is the favoring of the agrochemical selling industry to obtain their registrations in the shortest possible time and without a technical risk evaluation, which breaches the State's duties regarding agrochemical registration established in accordance with Articles 21 and 50 of the Constitution.

The paragraph challenged by the plaintiff states that "for formulated pesticides that do not have a registration for a technical grade active ingredient associated with that formulation and for which the manufacturer of that formulated product has been updated in accordance with this regulation, the SFE will grant the technical grade active ingredient registration certificate." The decree opposes any active scientific technical principle governing registration matters, as it grants a registration without even mediating the basic process governing registration regulations, which is chemical evidence.

Regarding Art. 4 (which amends Art. 5 of Decree No. 39995) The registration facilitation process established by Executive Decree No. 41481 runs counter to the State's duty to protect all Costa Rican society. Only requirements are listed to get by, which will not support any information for conducting a scientific technical risk analysis. This particular issue, because this entire regulatory proposal represents a setback to the regulations established in the country, is akin to returning to the period before or equal to the year 2004, in disregard of the rulings of the CGR.

Regarding Art. 5 (which amends Art. 6 of Decree No. 39995) The chemical equivalence process proposed in this article contravenes international standards, Constitutional Chamber ruling No. 2011-016937, and the reports of the CGR. A procedure for the evaluation of equivalence in formulated products has not been proposed by these institutions, and it alludes to the Manual on Pesticide Specifications and Equivalence CropLife 2014.

The proposal for the SFE to create and publish a database with toxicological, ecotoxicological, and environmental fate information can be limited to what has already been indicated by SANCO, since the sensitive information that can be classified as proprietary copyright is confidential, and hence it is not a solution, as set forth in this decree, to have all the information on a product.

Regarding Art. 6 (which amends Art. 7 of Decree No. 39995) With an unscientific registration proposal that departs from national and international standards, and which could be unconstitutional, the Executive Branch promulgated this decree which, consistent with its objective, should have been titled “Regulations for Registration Facilitation,” since the priority is the updating or revalidation of registrations with referenced information, pressuring registration analysts by shortening response times, proposing the registration process with only a simple verification of information, and separating the ministries of health and environment from its registration analysis.

Regarding Art. 9 (which amends and adds a new Art. 11 of Decree No. 39995) Continuing with the registration facilitation process and without any analysis that responds to a technical and scientific basis in accordance with national and international standards, the Executive Branch proposes to homologate the uses of one product with another that has similarity in the active ingredient, concentration, and formulation. In this particular case, the minimum that can be done is the chemical equivalence of the active ingredient, but since it refers to a formulation, the co-formulants must be analyzed. They must be declared, and a risk analysis can be carried out by the ministries of health and environment, along with presenting a biological efficacy study respecting the univocal rules of science and technique. One must consider that a formulated product is composed of a percentage of the active ingredient and the remainder, known as co-formulants, incorrectly called inerts. Often, the secret of the formulated product is not in the composition of the active ingredient but in the co-formulants, some of which are much more toxic to health and the environment than the active ingredient itself. This type of decree only seeks to give more time to agrochemical selling companies to continue with the marketing process and the use of substances that are dangerous and that can cause serious harm to the health of the Costa Rican population, affect biodiversity, and damage the environment, since the registrations have not been fully evaluated. In other words, they lack a chronic toxicology study, and none of these registrations have undergone an ecotoxicological assessment, and many might not be functioning at the doses for which they were registered. This type of decree could be considered a violation of human rights because the responsible authorities have not acted with due diligence and continue to postpone, through this type of decree, the evaluation of each registration's proprietary technical information. Furthermore, the decree lacks technical substantiation on the matter of pesticides and seeks to make requirements more flexible, to the detriment of the life and health of people, especially agricultural laborers and farmers.

The plaintiff requests that the unconstitutionality action be granted.

2.- Through the resolution at 3:40 p.m. on April 8, 2019, the Presidency of the Constitutional Chamber admitted the present unconstitutionality action. Additionally, the publication of the corresponding edicts in the Judicial Bulletin was ordered. The Procurador General de la República and the Minister of Agriculture and Livestock (Ministro de Agricultura y Ganadería) were granted a hearing.

3.- Through a brief received in this Constitutional Chamber on May 9, 2019, Luis Renato Alvarado Rivera, in his capacity as Minister of Agriculture and Livestock, responded to the hearing. Firstly, he indicates that the allegations made by the petitioner concern the administrative litigation venue and not the constitutional one, as the dispute relates to questions of legality. To this end, he proceeds to give a historical account of various legal norms related to phytosanitary matters. He says that if the petitioner considers that the norm should have been promulgated together with other bodies, such an argument should be discussed in that venue and not in the Constitutional Chamber. He considers that the executive decree in question acts in prevention of environmental risk and human and animal health. He adds that one of the objectives of the Phytosanitary Protection Law (Ley de Protección Fitosanitaria) is to regulate the use and handling of chemical, biological, or related substances and equipment for their application in agriculture; likewise, their registration, importation, quality, and residues, simultaneously seeking to protect human health and the environment. Therefore, the legal and technical norms relating to phytosanitary protection must be interpreted in accordance with the constitutional duty of the State and society in general to act in prevention of environmental risk and both human and animal health, as is effectively done when issuing Executive Decree No. 39995-MAG and No. 41481-MAG.

He affirms that the legislator conferred on the SFE the competence to achieve the purposes contained in the Phytosanitary Protection Law, and that such assignment of competence is exclusive to said body, within which the realization and custody of the respective registries falls. He cites, in support of his argument, Opinions No. C-171-2000, C-255-2009, and C-215-2013 of the Procuraduría General de la República (PGR).

He emphasizes that the decree for the updating of dossiers and its reform applies exclusively to all registrations of “technical grade active ingredient” (IAGT) and formulated products that were registered under a different norm (legal or regulatory) than Executive Decree No. 33495-MAG-S-MEIC-MINAET, “Regulation on the Registration, Use and Control of Synthetic Formulated Pesticides, Technical Grade Active Ingredient, Adjuvants and Related Substances of Agricultural Use”. That is, he underlines that it only applies to those registration dossiers of products already on the market and that were registered in accordance with the applicable regulations at the time of their approval and were fully evaluated (health, environment, and biological efficacy) according to those regulations. Therefore, if the petitioner believes that said regulation has legality defects, they must discuss them in the corresponding jurisdictional venue and not in the constitutional venue. He considers it unacceptable and improper for the petitioner to attempt to discuss in the constitutional venue legal aspects that are not within the purview of the constitutional venue but of the ordinary courts.

He argues that the petitioner confuses and attempts to create confusion regarding the agrochemicals that are registered and currently marketed in the country, which are those to which Executive Decree No. 39995-MAG and No. 41481-MAG apply, seeking to make it believed that they must be evaluated again, which is neither procedurally appropriate nor necessary, since all products registered in Costa Rica met the requirements and regulations established in the positive law in force at the time those registrations were granted. Consequently, he clarifies, vehemently and repeatedly, that for none of the pesticide products, whether raw materials or formulated products with a current registration, is there evidence or a technical scientific presumption, or at least indications, that presume an additional or resulting danger from the application thereof, regarding human health, the environment, or the biological efficacy of the pesticide. Both the Constitutional Chamber and the PGR have been clear in the sense that the Ministry of Health, the Ministry of Environment, the Ministry of Agriculture, and even private individuals can go to the ordinary jurisdictional venue to request the annulment of the administrative acts through which those registrations were granted, and can even request that their marketing be precautionarily suspended. However, neither the Ministry of Health, nor the Ministry of Environment, nor the petitioner does so because they lack proof, scientific and technical support, and, for that reason, recklessly resort to the Constitutional Chamber to raise legality issues through unconstitutionality actions, with the sole purpose and objective of hindering the process of organizing the agrochemical registration system undertaken by the Administration.

He insists that with the mentioned decrees ‒No. 39995-MAG and No. 41481-MAG‒ registrations are not being granted for new IAGT or for new formulated pesticides, but rather it only applies to old IAGT (raw materials) and formulated products.

He explains that it was as of 2007 that a registration system was established mandating the prior registration of the raw material ‒IAGT‒. Before that date, it was not necessary to register the IAGT, and that is why the Executive Branch issued the decrees under challenge. He adds that it is not as the petitioner indicates, that the challenged norms are facilitating the registration of new products, since the truth is that nothing is being facilitated, but rather a space is being opened for registration holders to submit the confidential chemical information that is essential to guarantee that there are no relevant impurities from a toxicological and ecotoxicological point of view in any of the products currently marketed by virtue of a valid, indefinitely granted registration. Therefore, it is not correct to affirm that with the application of these norms, the registrations that are updated in their dossiers pose an additional risk to health, the environment, or agriculture, since all IAGT registrations granted must necessarily and unavoidably correspond to one of the formulations already sold on the market, and regarding these formulations, the Ministry of Health or Ministry of Environment have broad and indisputable competencies and powers to adopt the appropriate measures to prevent harm to health or the environment, not only by resorting to the jurisdictional channel to annul the administrative acts under which the registration was granted, but also by precautionarily or provisionally preventing any act involving or entailing the importation, manufacture, handling, storage, transport, marketing, supply, and use and application of the product deemed harmful to health or the environment, as the PGR and the Constitutional Chamber itself have repeatedly stated.

He echoes that any granted registration can be revoked or annulled, obviously through the lesivity process, if it is shown to pose an unacceptable risk to health or the environment, and within that process, precautionary measures can be requested that entail the suspension of the importation, marketing, and use of that pesticide, until its registration is annulled. Thus, the radical environmentalists who unsuccessfully filed a writ of amparo and an unconstitutionality action against Executive Decree No. 39995-MAG of December 15, 2016, cannot expect the Chamber to annul the registrations without demonstrating and accrediting the scientific evidence proving the impact or risk to health or the environment.

He reiterates that the decrees are only applicable to old IAGT and formulated products, meaning those for which registrations were already granted in the country and that have been used for many years, a use that has allowed their behavior, safety, and efficacy to be known with certainty. All are products that already have a registration and, therefore, can be marketed because they have a current registration, in accordance with the regulation that was in force at the time they were granted. The registrations were granted because they met the requirements, procedures, and evaluations established by that regulation in force; therefore, those products are covered by a registration, and that legal situation cannot be ignored by the active administration.

Regarding the application of the precautionary principle in pesticide matters, he invokes PGR Opinion No. C-255-2009 and establishes that the competencies of the Ministry of Health and the Ministry of Environment and Energy remain, particularly regarding the life and health of people, and insists on the legality issues already explained. He reiterates that once a specific product is registered, the Public Administration creates a consolidated legal situation, and that in any case, precautionary or annulment measures can be ordered if any impact on life or health is verified.

He points out that Executive Decree No. 39995-MAG and its reform No. 41481-MAG allow for resolving the problems of disorder, uncertainty, and lack of information in the dossiers supporting the registrations of IAGT and formulated pesticides with current registration, but which were granted under a regulation different from Executive Decree No. 33495-MAG-S-MINAE-MEIC. He considers that the challenged regulation is a great advance and resolves a problem that began in 2004 and had not yet been resolved by previous administrations. It provides alternatives and ways to resolve the two most serious problems afflicting the registration system in our country: on one hand, the paralysis in the registration of new and generic products, and on the other, the impossibility of renewing the registrations of formulations currently on the market.

He establishes that one of the virtues of the executive decree in question is that it allows the application of the new regulation for the registration of sanitary products, as it standardized the validity period of registrations and associated the formulations with the manufacturers, in relation to previous executive decrees. In this regard, he details that the challenged regulation allows: a) the updating of manufacturers, their origin, and production sites of the IAGT associated with the formulations already marketed in Costa Rica and that were registered under different legislation; b) the same in relation to formulated pesticides; c) putting an end to the legal uncertainty regarding the validity of the IAGT and formulated pesticide registrations that were registered under prior legislation and regulations, standardizing the ten-year validity period for all registrations and thereby ending indefinite validity; equating the registrations of old formulations to the current registration system by granting them the IAGT registration, thereby eliminating the formulations that do not have one duly updated and associated; and organizing and updating the labels and leaflets with which formulated pesticides are being marketed in Costa Rica, in such a way that from the regulation on, any change or modification of the label and leaflet is recorded in the product's physical dossier.

He states that the regulation in question comes to comply with some provisions adopted since 2004 that have not been followed, specifically: 1) that all registrations must have a reasonable validity period, and with the decree, all registrations that had been granted for an indefinite period will now have a ten-year validity, meaning an end to indefinite registrations; 2) that all chemical information on purity, total impurities, or relevant impurities, as well as the synthesis pathway of the technical material with which the pesticide is formulated, must be included in the registration dossier.

He criticizes that the petitioner intends to hinder the dossier-updating process and does not provide documentary or scientific proof, and considers that an enumeration of the violated constitutional rights and guarantees is lacking. He insists that in dossiers 17-005922-0007-CO and 17-002503-0007-CO, an unconstitutionality action and a writ of amparo were filed ‒respectively‒ against the executive decree subject to this process, and that both were rejected, especially highlighting the reasoning of the separate note by Justice Hernández López in this regard.

He questions the petitioner's argument regarding the updating process as a reevaluation process, indicating that any of the products currently having a current registration can be suspended or annulled if they pose any risk to health or the environment. Furthermore, he alleges that the petitioner omits to say that these are products whose IAGT and the associated formulated product are already on the market, and they are not new products requiring an evaluation prior to granting a registration that allows their marketing. Therefore, the petitioner is incorrect in making such assertions, and he questions where the petitioner gets the idea that the updating process is a risk reevaluation process for a product already marketed and with a current registration.

He argues that the reports of the CGR invoked by the petitioner have been decontextualized and are intended to be applied to a different legal situation.

It indicates that in the case of report DFOE-AM-19-2004, the previous decree regulating the matter was in force —namely, 24337-MAG-S of 1995—, so the assessments made by the CGR at that time are not applicable:

“Finally, in the background, the plaintiff cites a report from the Comptroller General’s Office, taking it out of context and attempting to apply it to an absolutely different legal situation, and it seems to us that, although it is true that this is not a matter of constitutionality, we will make some clarifications regarding said report and its contextualization. Report DFOE-AM-19-2004 of October 20, 2004, analyzes what was happening with the functioning of the registry and its different processes at that time, as well as the regulations in force at that moment, in this case the Reglamento para Registro, Uso y Control de Plaguicidas Agrícolas y Coadyuvantes, promulgated by Decreto Ejecutivo number: 24337-MAG-S of 04/27/95, not in force since 2007, which remained in application for almost twelve years and even transcended the repeal of the Law that gave it origin, this because its legal basis was Ley de Sanidad Vegetal 6248 of 05/02/78 and not the Ley de Protección Fitosanitaria. Precisely Decreto Ejecutivo number: 24337-MAG-S of 04/27/95, which is the one that was in force at the time the Comptroller General’s Office conducted the audit of the registration processes, did not establish a separation of information files and did not even include within the list of requirements the presentation of confidential chemical information, nor had it incorporated the determination of IAGT equivalence as a registration modality, hence during the validity of said regulation there was no mention of equivalence registration, reference profile, confidential information, or protection of test data. Regarding the prior evaluation of the impact of pesticides on health and the environment, report DFOE-AM-19-2004 of October 20, 2004, is clear in the sense that it was not being done efficiently, which was logical since the SFE did not have within its structure the competent units to evaluate the toxicological and ecotoxicological information provided by registrants, and therefore determined that said evaluation should be carried out by the Ministry of Health and the Ministry of Environment, respectively. The Comptroller General’s Office also recommended, in the report in question, that a new regulation should be issued under the support of the Ley de Protección Fitosanitaria, since the law supporting the regulation in force at that time had already been repealed.” “One aspect to highlight is that when report DFOE-AM-19-2004 of October 20, 2004, was issued, FAO had not prepared (it did so in 2006) the document where the registration of IAGT had been provided for when there was no reference profile with referenced information; in effect, the FAO document: AGENDA ITEM NUMBER 12.3A. INTERNATIONAL CODE OF ON THE DISTRIBUTION AND USE OF PESTICIDES: DRAFT GUIDELINES ON DATA REQUIREMENTS FOR THE REGISTRATION OF PESTICIDES, which is from October two thousand six, states the following: ‘**If there are no technical products registered in the country with complete data, the technical grade active ingredients intended to be registered cannot do so through equivalence, but through the normal procedure (…) For products for which a complete risk assessment has not been carried out in a given country, due to the lack of data and/or failures by the original registrant(s) to provide the complete data set required for a risk assessment, any active ingredient previously registered by the original registrant(s) or subsequent registrants can be used by the registration authorities of a country as a reference source for the equivalence assessment,** ***provided that all the chemical information required for registration is available, regardless of whether the risk assessment is not complete***’.” (The underline does not correspond to the original).

It also mentions that said report was issued prior to the enactment of Law No. 8622, which incorporated the Dominican Republic-Central America-United States Free Trade Agreement (CAFTA, for its acronym in English) into the Costa Rican legal system. In this same vein, it establishes that when said report was issued, the Food and Agriculture Organization of the United Nations (FAO, for its acronym in English) had not yet promulgated the Manual on the Development and Use of FAO and WHO Specifications for Pesticides, the principle of non-repetition of studies, a principle incorporated in Considerando XIII of Decreto Ejecutivo No. 40059-MAG-MINAE-S:

“In said principle, FAO and WHO recognize that the repetitive generation of studies and information regarding all potential/real risks for each manufacturer of a pesticide may be unnecessary and ethically undesirable. **Obviously, report number: DFOE-AM-19-2004 of October 20, 2004, from the Contraloría General de la República, was issued prior to the entry into force of international agreements on the protection of test data and before the incorporation of the principle of non-repetition of test data by FAO and WHO.** (…)

This principle is a fundamental principle in the registration process, not only because it enshrines at a regulatory level a thesis, based on science and chemistry, that we in the generic industry have historically sustained, in the sense that chemical equivalence between two IAGTs makes it unnecessary to require toxicological, ecotoxicological, or environmental fate and behavior studies. This general principle must be observed and complied with by national authorities; therefore, registrants are empowered to invoke said principle when requesting exemption from any of the tests or studies established in the Reglamento de Registro. In this regard, we must remember that unwritten norms (custom, jurisprudence, and general principles of law) are useful for the interpretation, application, and integration of the written order, so that in cases of insufficiency or regulatory vacuum, general principles constitute a source of law.” It refutes the aforementioned CGR report No. DFOE-AM-19-2004, pointing out that in 2013 a reform took place in the International Code of Conduct on the Distribution and Use of Pesticides of the FAO, and therefore considers the report inapplicable. It affirms that said Code promotes that States establish a pesticide registration and control system and mentions PGR opinion C-215-2013, which refers to this international norm. It complements the above by indicating that a CGR report cannot grant powers of authority related to the registration of pesticides to other ministries and insists that competence in pesticide matters corresponds to the SFE, according to the Ley de Protección Fitosanitaria. It states that the reform operated by Decreto Ejecutivo No. 41481-MAG on Decreto Ejecutivo No. 39995-MAG does not allow the registration of new pesticides —new, according to Art. 15.10 of CAFTA— and that the reform that operates is linked to the modification of deadlines and administrative requirements.

It insists that it is the MAG, through the SFE, that is the competent body for the reception, verification, and evaluation of registration certificates, as a power of authority originating in the Ley de Protección Fitosanitaria, excluding the participation of other bodies such as the Ministry of Health and MINAE:

“As long as the SFE adjusts its structure and includes within the Registration Unit the areas of Chemical Evaluation, Toxicological Evaluation, and Ecotoxicological Evaluation, it could not even be insinuated that there is a deterioration in environmental regulations, because as we have already explained, it was the legislator who, in the Ley de Protección Fitosanitaria, conferred upon the MAG, through the SFE, the competence to create and manage the registry of pesticides for agricultural use. Therefore, this decentralized body must have a technical, organizational, and administrative structure that seeks not only the quality and efficacy of pesticides but also their safety, to ensure that both the environment and human health are protected, guaranteeing that the use of these substances does not represent unacceptable risks to health and the environment.” **Regarding the plaintiff’s analysis of the articles of Decreto Ejecutivo No. 41481-MAG of December 10, 2018, it states the following:** **Regarding Art. 1** As can be seen, said text compared to the text without reform, maintains its scope of application in the sense that this regulation cannot be used to register new pesticides (new according to the concept of Art. 15.10 of CAFTA and Art. 8 of the Law on Undisclosed Information), and the only thing that changes is related to deadlines and one of the administrative requirements. The plaintiff objects to the issue of deadlines which, as we reiterate, is a legality issue that must be resolved in another venue and not in the constitutional venue. It is important to make clear that it is the competent authority that determines the deadlines in which certain acts must be performed and the deadlines that the administered party must meet for their procedures under the norm. It also analyzes the issue of requirements and even issues an opinion on what, according to the plaintiff, the requirements should be, the procedure for evaluating them, and which authorities should intervene in them, which is not only procedurally unacceptable but legally there is a scheme of competencies, and Law No. 7664 expressly confers them to the MAG and the SFE. From the relationship of articles 23, 24, 25, and following and concordant of the Ley de Protección Fitosanitaria, with Art. 11 of the Constitution and numerals 11 and 59 of the LGAP, it can be affirmed that the procedures for reception, verification, evaluation, and issuance of registration certificates constitute a power of authority conferred by the legislator to the MAG through the SFE. Therefore, it considers that in this matter it would be prohibited to confer powers of authority through decree, just as it would be unacceptable from a strictly legal perspective to base an executive decree, competencies for the Ministry of Health and MINAE, on general laws related to the environment or human health, when the legislator, in a specific law (Ley de Protección Fitosanitaria), provides not only the body responsible for exercising those competencies but also, by express norm (Art. 23 of the Ley de Protección Fitosanitaria), establishes that the requirements for the registration of chemical, biological, biochemical substances, coadjuvants and related substances, and agricultural application equipment will be established in the regulations to the Ley de Protección Fitosanitaria. Therefore, it is clear that in application of the principles of legal hermeneutics, all norms, requirements, and procedures for registration are those contemplated in the regulations to that law.

**Regarding Art. 2** The plaintiff limits themselves to objecting to issues of mere legality and fails to address the alleged unconstitutionalities of the norm they object to. Even from a pure and simple reading of the text, it is evident that the plaintiff's statement, in the sense that registrations are being granted to new products through this regulatory norm, is fallacious. Neither is it true, as the plaintiff states, that agronomists are in charge of reviewing chemical information; but, beyond the inaccuracies and fallacies incurred by the plaintiff, what is evident is that their allegations are about administrative aspects and mere legality, which the Sala Constitucional is not responsible for resolving, but rather the ordinary jurisdiction.

**Regarding Art. 3** As for the aspects related to deadlines, with “unacceptable audacity”, it refers to institutional workloads, forgetting that what is being raised and submitted to the knowledge of the Sala is an unconstitutionality action against a norm issued by executive decree. Thus, it confirms that we are facing a questioning of administrative aspects and mere legality by the plaintiff in a jurisdictional venue that is not competent to hear these matters. It draws attention to the plaintiff's mention of a technical aspect that reveals their profound ignorance of the matter regulated by the challenged decree and, out of respect for science and the registration system, explains very succinctly:

“As we had already pointed out, in Costa Rica before January 10, 2007, the registration system established that a formulation could be registered without needing to have a registration of the raw material, that is, of its technical grade active ingredient (IAGT). After that date, it was established that any formulation, prior to being registered, required the registration of its IAGT. This means that currently, an enormous number of around one thousand five hundred formulated products are not associated with a manufacturer. That is why Decreto Ejecutivo No. 39995-MAG of December 15, 2016, and its reform (Decreto Ejecutivo No. 41481-MAG of December 10, 2018, published on January 11, 2019, scope number 8 of the Diario Oficial La Gaceta), establish an update process that will allow the registration system to guarantee that every formulation marketed in the country will be associated with a manufacturer of the IAGT. In such a way that this manufacturer update does not imply that registration is being granted to a new product, but rather that through this update process the authority will have the necessary information to determine if the technical material with which that formulated product is formulated does not contain relevant impurities and also complies with the international specification that every IAGT must meet for the formulation of pesticides. Therefore, what the plaintiff indicates regarding the lack of technical or scientific basis and the confusion they make with registration under the equivalence modality is incorrect, because the process proposed is not an equivalence but an update of the information of a current registration of a formulated product that does not have a manufacturer of IAGT associated with its registration, remembering that by virtue of Article 3 it is not authorizing a new product but associating a manufacturer to that formulation that already has a registration and is marketed in the country.” The plaintiff's technical and scientific ignorance of the matter leads them to assimilate the update process established by Decreto Ejecutivo No. 39995- and its reform No. 41481-MAG, with the equivalence registration modality established in the Reglamento Técnico de Registro (Decree No. 40059-MAG-MINAE-S). Furthermore, the plaintiff organization forgets that in Costa Rica, the equivalence registration modality is based on chemical equivalence, and therefore technical information is not required, as established by the equivalence registration systems promoted by FAO.

**Regarding Art. 5** In analyzing Art. 5, the plaintiff confuses the concept of manufacturer with that of formulator, such that all the hypotheses, objections, and analysis they make of said norm are not applicable to the legal situation regulated by the update of formulators in Decreto Ejecutivo No. 39995-MAG of December 15, 2016, and its reform No. 41481-MAG.

**Regarding Art. 6** Article 6 of the challenged decree guarantees in its current wording, first, that Costa Rica will cease to have indefinite-term registrations, and rather, starting from the update, all registrations of IAGT and formulated products will have a validity of 10 years, imposing the obligation to renew them. It will not be as it is now, where being indefinite-term, they do not need to be renewed as they have no expiration date; second, that it will guarantee that all formulations currently sold on the market will have an associated manufacturer, and not as it is now, where the sites and origins of manufacture of the raw materials are unknown; third, that every IAGT used in the country for the formulation of products authorized for marketing here has its purity accredited and does not have relevant impurities above the international specification; fourth, that all IAGTs used in Costa Rica comply with the international conventions signed by Costa Rica (Annex III of the Rotterdam Convention, the Stockholm Convention, or the Montreal Protocol); and fifth, that the SFE will create a database of toxicological, ecotoxicological, and environmental fate information of the technical grade active ingredients that are registered and do not have current test data protection periods. It is very important that the SFE has a bank of information for molecules that are not new and whose test data are free to use because they do not have current protection periods. It is necessary for companies holding toxicological, ecotoxicological, and environmental fate information on technical grade active ingredients that are not new to contribute information they have managed to compile, which will serve so that in the future the SFE can gradually build a complete toxicological, ecotoxicological, and environmental fate and behavior profile, allowing for a reference profile for equivalence registrations.

**Regarding Art. 7** The current text bears no relation or congruence with the plaintiff's reckless comments and statements on this specific article. Regarding the assertion that this norm reverses the burden of proof principle or the precautionary principle, it is rejected “absolutely and categorically”, not only because it is a legality issue to be discussed in ordinary jurisdiction, but also because the current text of Art. 7 is supported by repeated opinions of the PGR and rulings of the Sala Constitucional. It considers it incorrect and reckless to maintain, as the plaintiff does, that the questioned decree violates the precautionary principle in environmental matters, just as it is incorrect to indicate that the burden of proof is reversed.

It points out that the norm subject to action does not allow or make it possible to grant registrations for new products to those already marketed, this because its scope of application is very clear and it is only feasible to apply it to current registrations that were granted under regulations (legal or regulatory) different from Decreto Ejecutivo No. 3495-MAG-SMINAE-MEIC and its reforms. That is, “it is not feasible to register new IAGTs or new formulations with new IAGTs”, and the IAGTs that are granted necessarily and unavoidably. With this regulation, registrations of IAGT, and much less of formulations not already on the market, will not be granted. Regarding the agrochemicals registered and currently marketed in the country, there is no additional danger resulting from the application of the same, in terms of human health, the environment, or the biological efficacy of the pesticide. Therefore, it is not correct to affirm that with the application of the decree, the registrations whose files are updated pose an additional risk to health, the environment, or agriculture, since all, absolutely all, registrations of IAGT that are granted must necessarily and unavoidably correspond to one of the formulations already sold on the market, and over these formulations, the Ministries of Health or Environment have broad and indisputable competencies and powers to adopt the pertinent measures to prevent damage to health or the environment, not only by going to the jurisdictional route to annul the administrative acts under which their registration was granted, but even by precautiously or provisionally preventing any act that implies or entails the importation, manufacture, handling, storage, transportation, commercialization, supply, and use and application of the product considered to harm health or the environment. With certainty, the challenged regulation is only applicable to products that have already been granted a registration and therefore can be commercialized. All these products, to which the decree under analysis applies, were registered because they met the requirements, procedures, and evaluations established by the regulations in force at the time their registration was granted, so these products are covered by a registration and that legal registration situation cannot be ignored by the active Administration. In this regard, the PGR was already clear and forceful in opinion number C-255-2009 by affirming that pesticide registrations (IAGT or formulated) that currently have a current registration are therefore authorized to be commercialized in the country. The foregoing proves that there is no violation of the precautionary principle in environmental matters, nor is the burden of proof principle being reversed, since because these are products that are commercialized, covered by a registration, this implies that said product already met the requirements and procedures established by the regulations in force and was also evaluated according to those regulations by the competent authorities. Therefore, it is clear and indisputable that the active Administration must respect that legal situation and the right of the administered party, so that, to annul the act that conferred it, it must follow the procedures set forth in the Código Procesal Contencioso-Administrativo, aimed at declaring the harmfulness and annulment of the registration act, and may even, as a precautionary measure, while the harmfulness is declared, prevent the importation, manufacture, handling, storage, transportation, commercialization, supply, and use and application of the product considered to harm health or the environment.

**Regarding Art. 11** The plaintiff contributes nothing more than a transcription of parts of a report from the Comptroller entity that is absolutely decontextualized and not applicable to the specific situation. The homologation of formulations proposed in Art. 11 of the challenged decree is based on the manual of specifications of the FAO and the World Health Organization (WHO) for the development of pesticide specifications.

Following the previous particular analysis of the challenged norms, it reiterates the attribution of competence in matters of registration of agrochemical substances that various legal and regulatory norms assign to the MAG through the SFE, and, in this sense, provides transcriptions of opinions from the PGR and rulings from the Sala Primera of the Corte Suprema de Justicia.

**Regarding the conclusions of the claimant** The legislation under examination applies only to old products, that is, products for which registrations of IAGT or formulated product have already been granted, and many of those registrations were granted for an indefinite term. This means they do not require the updating decree to continue being marketed; therefore, rather than facilitating, it is about imposing an obligation on them to update their information and provide data and studies that certify not only the provenance and origin of the technical materials and associated formulations, but also provide confidential chemical information that allows the registration authority, namely the SFE, to have available the confidential chemical information on purity, impurities, synthesis method, etc., of their technical materials, both regarding manufacturers and formulators. This confidential chemical information demonstrates whether the IAGT has impurities of toxicological or ecotoxicological relevance that may have an effect on health or the environment. This information is not currently held in the registrations that must be updated.

Depending on the relevant impurities and their concentration, the registration authority can make regulatory decisions regarding the continuation or not of a registration or of a manufacturer of a technical material of a formulation being marketed in Costa Rica.

The claimant maintains or insinuates, without substantiating it, that every manufacturer of IAGT must provide their own test data, that is, that each manufacturer should carry out chronic, subchronic, toxicological studies, ecotoxicological studies, and environmental fate and behavior studies. Thus, it intends to obligate the manufacturers of IAGT used in the formulation of pesticides to carry out these studies (the claimant does not explain why the manufacturers of active ingredients used in human medicines are not asked to do the same). This pretension that the claimant outlines is absolutely censurable by FAO and WHO, since both international organizations, in the Manual on the Development and Use of FAO and WHO Specifications for Pesticides, have incorporated the principle of non-repetition of studies, a principle that is incorporated in considerando XIII of Executive Decree No. 40059-MAG-MINAE-S.

Nor is it true that the registered technical materials and formulated products have never been evaluated, as the claimant recklessly states in his conclusions; all registered products were inscribed after verifying that they met the requirements established by the legislation in force, and the MAG and the SFE could not, as the claimant intends, come to disregard this legal situation and the rights of the governed parties.

The technical, philosophical, and legal basis of both Executive Decree No. 39995-MAG and its amendment No. 41481-MAG of December 10, 2018, is found in the recital and legal parts of both regulations. In this case, the Phytosanitary Protection Law No. 7664, whose purpose is to regulate the use and management of chemical, biological, or related substances and equipment to apply them in agriculture; likewise, their registration, importation, quality, and residues, while seeking to protect human health and the environment, all of which must be inscribed in the registry that the SFE will create to have information on the characteristics of these and ensure their correct use in the country.

It is essential to guarantee the supply and continuity in the marketing of products that currently have a valid registration, making it necessary to update the information in their files on their characteristics and ensure their correct use in the country. The same decree indicates in its recitals that the regulations prior to the entry into force of Executive Decree No. 33495 MAG-S-MINAE-MEIC of October 31, 2006, and its amendments allowed the MAG to grant registrations for an indefinite term, as well as the inscription of formulated pesticides without it being a requirement to have a prior IAGT registration, which obligates the Executive Branch, within its constitutional and legal powers, to organize its registry, ordering the updating of the information of registrations inscribed for an indefinite term, having been granted under previous legislation.

The questioned regulations aim to update the files with the information that was not requested at the time of their registration, through a re-registration process in accordance with art. 50 of the Constitution.

**The importance of Executive Decree No. 39995-MAG and its amendment, Executive Decree No. 41481-MAG** *From the technical and scientific point of view*: It allows the State to have all the information on purity, relevant impurities (name, content and detection levels), total impurities, synthesis method, analytical methodologies to determine the IAGT and its relevant impurities, of all IAGTs registered as such or as components of a formulation, that were registered in Costa Rica under legislation and regulations different from Executive Decree No. 33495-MAG-S-MEIC-MINAET. The confidential chemical information required by this decree is key and essential from an agronomic, toxicological, and ecotoxicological point of view, and unfortunately, it is not incorporated into the files of these registrations. Much of the chemical information requested in the decree, especially that described in arts. 1 and 5, although presented during the revalidation process, is completely outdated, since 5 to 10 years have passed since the information was provided, and the authorities have not yet reviewed it, much less approved it. It allows the Costa Rican State to have updated information on the formulation sites and origins, the name and physical location of the formulators, as well as the components of the product and the detailed description of the formulation processes of all the formulated products currently marketed in Costa Rica.

*From the chemical and scientific point of view*: It guarantees that no formulated pesticide, marketed in Costa Rica, can be registered and therefore marketed if it does not have an associated IAGT that has levels of relevant impurities (which are those with toxicological and ecotoxicological importance) higher than the levels specified in international reference standards (FAO, EPSA, IUPAC).

*From the legal point of view*: It achieves equating old registrations (those not registered under the protection of Executive Decree No. 33495-MAG-S-MEIC-MINAET) with the registrations granted under the registration system (which establishes registration of the IAGT as a prerequisite for the registration of a formulation), whereby all currently registered formulations will have their corresponding associated IAGT (with its current manufacturer, its origin and site of production or synthesis), duly registered. The information in the technical dossier is absolutely congruent, not only with the principle of non-repetition of studies promoted by FAO and WHO, but also with doctrine and comparative law. It grants legal security to registrants and agricultural producers regarding the supply of the formulated products currently being marketed. It constitutes the legal instrument that allows the application of the new registration regulation, by standardizing the validity of the registrations and by associating the formulations with the current manufacturer of its IAGT and the current formulator (national or foreign) of the product.

*From the political point of view*: Another of the novelties and benefits of the regulation for updating files is that it will allow solving a problem that past administrations have not been able to solve, despite having tried to do so through transitory decrees (change of manufacturer) and revalidation processes. In Costa Rica, a very high percentage (perhaps 80% or 85%) of the formulations marketed do not have the respective IAGT associated with their registration, which not only leaves the protection of health and the environment in a state of vulnerability but also prevents registrants from improving their formulations or registering new ones. This is overcome with the new regulation. Now, with this decree, the problem of formulations that do not have an associated IAGT registration is solved, for which the current administration merits great credit, as the regulation for updating registration files constitutes a legal instrument of high political value. It resolves the problem and the uncertainty (technical and legal) in which registrations granted under regulations of various ranks, different from those established by Executive Decree No. 33495-MAG-S-MEIC-MINAET, find themselves. Through this new decree, the authority is empowered and the mechanisms are provided for it to have technical and chemical information that guarantees that the pesticides currently marketed do not represent an unacceptable risk to agriculture, health, or the environment.

*From the agronomic point of view*: It organizes and updates the labels and pamphlets with which the formulations are marketed in Costa Rica, in such a way that the factors involved in the use of a formulated pesticide, namely, the concentration of the technical grade active ingredient in the formulation, the application doses, the period and number of treatments, the use of adjuvants and the methods and places of application that determine the applied quantity, the periodicity of the treatment and the pre-harvest interval, as well as all the factors inherent to the modality of use of a formulated pesticide. All of this is a faithful reflection of the product's file.

It requests that the appeal be declared without merit.

**4.-** The edicts referred to in the second paragraph of art. 81 of the Constitutional Jurisdiction Law (LJC) were published in numbers 84, 85, and 86 of the Judicial Bulletin, of May 8th, 9th, and 10th, 2019.

**5.-** By brief received at 10:05 a.m. on May 10, 2019, **Julio Alberto Jurado Fernández** appeared to answer the hearing granted to the **PGR**, and stated the following:

**On standing** The party has standing for the filing of the action of unconstitutionality, as it appears in defense of diffuse interests, related to arts. 21 and 50 of the Political Constitution.

**On the merits** The object of this constitutional process is closely related to another similar one, which is processed under file 18-19039-0007-CO, so the accumulation of this process to the one previously indicated is suggested.

Before Executive Decree No. 33495 of 2006 was issued, to register a formulated pesticide it was not necessary to previously register the technical grade active ingredients required for that formulation, and the registrations were granted without a defined term, nor were the same technical requirements demanded. As a result of the above, Executive Decree No. 33495 established a revalidation process, so that the holders of IAGT registrations, granted before the promulgation of said regulation, would provide the SFE with the necessary information to sustain the validity of their registrations. Subsequently, Law No. 8702 was promulgated, which established a revalidation process similar to the aforementioned decree, and Executive Decree No. 33495 was repealed with the issuance of Executive Decree No. 40059 ‒the object of another action of unconstitutionality, processed under file 18-009107-0007-CO‒. Subsequently, Executive Decree No. 39995 was issued, which established another revalidation process for the registration of pesticides, subject to a term. Before this term elapsed, Executive Decree No. 41841 ‒the object of the present action of unconstitutionality‒ was issued, which extended the revalidation period to sixty months from its publication. In the recitals of said decree, it is explained that the SFE suspended the application of Executive Decree No. 39995 in response to a consultation from the SFE's internal audit to the PGR and that "due to lack of procedure, it has not been possible to update the information of any of the registrations of the technical grade active ingredients (IAGT) and of the formulated products that do not have an IAGT registration and that were not inscribed in accordance with Executive Decree No. 33495". In addition to modifying the term established in art. 1 of Executive Decree No. 39995, some requirements and procedural aspects of said decree are varied, apparently based on recital six, which provided:

*"That technical grade active ingredients are used solely for the formulation of synthetic chemical pesticide formulated products and are only exceptionally used directly in the field, and these exceptional situations are already regulated in the current technical regulations; therefore, the registration certificates for technical grade active ingredients are only useful for authorizing, by the State Phytosanitary Service, the importation of these as raw material for pesticide formulations in process plants and not for their direct use in the field."* &nbsp; **On the analysis of the constitutionality of the challenged norm** As stated in the report for action No. 18-19039-0007-CO, the Attorney General's Office is not competent to assess strictly technical aspects and determine whether the requirements and information listed by the challenged norm are adequate or not to carry out a correct assessment of the environmental and health risk of pesticides; therefore, in that aspect, the constitutionality analysis must take into account the technical information that is submitted to the file.

In the report for action No. 18-19039-0007-CO, the Attorney General's Office indicated that the revalidation process of Decree No. 33495 required certain technical requirements that were not contemplated by Decree No. 39995, despite the fact that the recitals of the latter acknowledge that it concerns the updating of products that have not met the toxicological, ecotoxicological, and environmental fate information requirements established in international regulations and required since the entry into force of Decree No. 33495. Therefore, based on the foregoing, it was indicated that if the technical reports submitted to the file confirm the above and show that there are no technical criteria justifying the content of the norm and determining that with the required requirements it is not possible to carry out an adequate assessment of the environmental and health risk, the principle of non-regression of environmental protection (principio de no regresión ambiental) and the principle of objectification of environmental protection (principio de objetivación de la tutela ambiental) would be violated, because the levels of environmental and health protection established by Decree No. 33495 would be decreased without a study supporting the adoption of that measure. Furthermore, it was argued that the preventive principle would be infringed, since, by not requiring information that allows an adequate assessment of the environmental and health risk of the products, it is not possible to adopt measures aimed at avoiding, mitigating, or correcting the adverse effects that pesticides generate on the environment. And that, even, this would imply a violation of the precautionary principle, since, without an adequate review of the health and environmental risk of pesticides, there would be no scientific certainty that they do not produce environmental impacts.

In this case, the technical basis of Decree No. 41481 must first be assessed, which motivated the extension of the revalidation period by five more years and justifies the possibility of continuing to market pesticides, even though they have not adjusted to the revalidation process and their effects on health and the environment have not been determined.

The formulation of a consultation to the Attorney General's Office, contrary to what is indicated in the recitals of the decree, does not suspend the application of the norms that are the object of the consultation. And, therefore, the consultation raised by the internal auditor of the SFE regarding several questions related to decrees numbers 39461, 40059, and 39995-MAG, and which gave rise to opinion No. C-199-2017, did not imply the suspension of the revalidation process established by Decree No. 39995.

Likewise, it must be technically assessed whether the requirements established by the challenged norm for the revalidation process allow for an adequate assessment of the environmental or health risk of the products, since, from a mere comparison of the texts of Decree No. 39995 and Decree No. 41841, it is verified that the technical requirements that Decree No. 33495 did contemplate were not added, but rather, some points were eliminated and modified.

For example, in art. 1, the acute toxicity studies and the ecotoxicity studies that Decree No. 33495 contemplated are still not required, and these are required only for cases in which the manufacturer has changed and the product presents relevant impurities, which is determined according to international reference specifications and standards. In addition, in art. 1.1, the request for manufacturer update, the registration certificate issued by the authority of the country of origin, and the endorsement of a chemist for the qualitative-quantitative composition certificate were eliminated. In art. 1.2, the registration certificate issued by the authority of the country of origin was eliminated and the way of indicating the chemical name in the analytical certificate of active ingredient composition was changed; and in art. 5, the certificate of the country of origin and the chemical endorsement of the qualitative-quantitative composition certificate and the certificate of analysis of the formulated product were eliminated, and the possibility of proving, by means of an affidavit from the registration holder, that the composition of the formulation has not changed and that an authorized active ingredient is used is maintained.

Subject to what is established in the technical criteria that are submitted, if it is confirmed that the challenged norm lacks a technical basis and that it relaxes the requirements and extends the period of the revalidation process, preventing a correct evaluation of the effects of pesticides and allowing their marketing in those terms, the Attorney General's Office considers that the action of unconstitutionality must be declared with merit. Unless, as recommended in file No. 18-19039-0007-CO, the Chamber considers that the challenged decree does not undermine the powers of the SFE to require any other pertinent and necessary information to carry out an adequate evaluation to determine that the use of the product does not affect health or the environment, as has been indicated on other occasions.

In that same sense, the unconstitutionality of art. 2 must be declared if, based on the technical criteria submitted to the file, it is determined that the reduction of the period from three months to one month, for the SFE to verify and analyze the information presented, resolve the product update request, and issue the registration certificate, prevents an adequate assessment of the environmental and health risk of the product from being carried out. Notwithstanding what is resolved regarding that article, it is convenient for the Constitutional Chamber to clarify whether the rule that the figure of positive silence (silencio positivo) does not operate in the case of environmental approvals or authorizations is applicable, and that, therefore, the Administration's non-compliance with the established period would not imply the automatic approval of the product revalidation.

**On the possibility of registering products using referenced information**, the Attorney General's Office, in the report rendered in file No. 18-19039-0007-CO, considered that in the event it is confirmed that there is no technical support and that with the type of information required it is not possible to carry out an adequate assessment of the environmental and health risk, the articles that contemplate that possibility would be unconstitutional, for violating the principles of objectification of environmental protection, the preventive principle, and the precautionary principle.

Furthermore, vote No. 16937-2011 was cited, which declared unconstitutional subsection b) and the reference in the penultimate paragraph to said subsection b) of section 7.3.2 of art. 2 of Executive Decree No. 33495, insofar as it allowed registration by equivalence of technical grade active ingredient products using as a reference profile other registrations that did not have complete information, because for the inscription of the latter, in addition to acute toxicity and ecotoxicity studies, additional chronic toxicology studies, ecotoxicological studies, and other studies on the abiotic environment were not required, as required by art. 5 of the Law for the Importation and Quality Control of Agrochemicals and the Manual on the Development and Use of FAO and WHO Specifications for Pesticides (which is applicable according to the provisions of art. 44 of the Phytosanitary Protection Law and art. 6.1.7 of the FAO International Code of Conduct on the Distribution and Use of Pesticides).

Based on the foregoing, although the Attorney General's Office is not a technical body in the matter, it can be indicated that although the challenged decree amends arts. 1.2.b and 6 of Decree No. 39995, which allowed products to be registered by means of referenced information, it maintains that possibility, since art. 1.2.c allows the use of international specifications to prove that the technical material to be updated does not have relevant impurities, indicating in recital five that international specifications and standards are a technical and scientific reference for determining that technical grade active ingredients do not contain relevant impurities at levels higher than the international standards or specifications, and that only these relevant impurities are those with toxicological or ecotoxicological relevance that can cause an impact on health or the environment.

In that same sense, art. 3 provides that formulated pesticides that do not have an associated technical grade active ingredient registration will be directly granted that registration when the manufacturer of that active ingredient has been updated.

6 states that once the requirements are met, the registration will be granted for 10 years and that, during that period, the SFE will verify that already approved records of technical-grade active ingredient have chemical equivalence with the reference profile of that active ingredient and that, in the absence of that profile, it must be verified that they do not contain relevant impurities.

Art. 11 endorses the homologation of labels and leaflets with those of other already registered products that have the same active ingredient and equal concentration, without contemplating the effects that the other components of the product or the form or method of preparation could have.

The challenged norm does not establish in what manner the information will be verifiable, how to determine which international specification may be used, the method for determining the equivalence of products, nor whether the reference profile to be used must be a registration that has complete information and, therefore, that encompasses the acute toxicity, ecotoxicity, chronic toxicology, ecotoxicological studies and other studies on the abiotic environment as required by Art. 5 of the Law for the Import and Quality Control of Agrochemicals and the FAO and WHO Manual on Development and Use of Pesticide Specifications.

By not precisely establishing the rules to which the competent authority must adhere to verify the information, it is possible that the updating of registrations with referenced information that does not meet the indicated requirements is permitted, and, therefore, this would imply the updating of product registrations without a prior evaluation of the environmental and health risks of their application.

If the foregoing is verified, according to the technical criteria issued to that effect, this would imply the unconstitutionality of the articles that allow the use of referenced information without an adequate equivalence determination.

Regarding the exclusion of MINAE and the Ministry of Health from the registration update process, the Attorney General's Office indicated that the revalidation process regulated by decree No. 33495 provided that the competent institutions could request additional information and that this suggests that the participation of those Ministries was included. Therefore, it was considered that the non-participation of the corresponding technical departments of those portfolios in the process established by decree No. 39995 implies a setback in the level of protection and a violation of the principle of objectification of environmental protection (principio de objetivación de la tutela ambiental), since it would allow the updating of registrations without the technical opinion of those dependencies within their field of competence.

The same must be said of the challenged decree, insofar as it carries that same defect by not including the participation of those Ministries, unless the Court considers that the powers attributed to other bodies in their respective enabling laws are not repealed or modified by the challenged norm and that the SFE, within the exercise of its legal powers, can and must request the participation of any specialized technical body to verify that a pesticide does not threaten health and the environment.

Regarding the improper reversal of the burden of proof that, in the opinion of the claimant, reformed Art. 7 contemplates, the Attorney General's Office reiterates that this does not undermine the constitutional duty that, by virtue of the precautionary principle, the competent authorities have to apply the powers provided in Arts. 25 and 30 of the Phytosanitary Protection Law and Art. 5 of the Law for the Import and Quality Control of Agrochemicals, to "deny, suspend or cancel the registration of chemical, biological or related substances", "restrict or prohibit the importation, transit, re-consignment, manufacture, formulation, repackaging, storage, sale, mixing and use of chemical, biological or related substances and application equipment for agricultural use, when justified by technical reasons" and to "prohibit the circulation or order the destruction of products that do not comply with quality standards, as well as take other measures aimed at improving the quality of agrochemicals".

In conclusion: The analysis of this unconstitutionality action implies assessing whether the defects attributed to decree No. 39995 in unconstitutionality action No. 18-19039-0007-CO have been corrected in the challenged decree, or whether, on the contrary, they persist or are aggravated.

**6.-** By brief received in this Constitutional Court at 18:42 hrs. on May 20, 2019, Mr. **Jaime Enrique García González**, doctor in agricultural sciences and professor of the Agriculture and Environment Area of the Environmental Education Center of the State Distance University, specialist in pesticides, files a coadjuvancy in this process. He proceeds to propose documentary evidence, consisting of resolution 153-2014-VI of the Contentious Administrative Tribunal, as well as resolution 1030-2018 of the First Chamber of the Supreme Court of Justice.

**7.-** By brief received at 11:04 hrs. on May 29, 2019, Mr. Jorge **Arturo Osborne Escalante**, identity card no. 1-0417-1413, in his capacity as legal representative of the Association National Chamber of Banana Growers ("CANABA", hereinafter), with legal entity identification number 3-002-056468, proceeds to appear in this process as a passive coadjuvant. Regarding his standing, he argues that it derives from CANABA's purpose, which is the defense of the interests of its members, linked to the banana activity in the country. He considers that he has a legitimate interest, derived from the use of pesticides to control pests and diseases in the cultivation and commercialization of bananas. He alleges that the members of said association use registered pesticides as part of their commercial activity and that this allows them to maintain their productivity and exports, hence he considers that he has sufficient legitimate interest to appear as a passive coadjuvant in this process. On the other hand, he believes that the claimant lacks active standing, since he does not indicate how executive decree No. 41481-MAG affects him and indicates that the certification of legal representation provided does not verify the date of issuance, for which reason he considers it should not have been admitted. Regarding what the claimant calls the objective of the action, the legal representative of CANABA says that the brief contains a series of allegations that lack foundation. He maintains that now an obligation is imposed to update the information and to provide data and studies referring to the technical materials and the formulations made, as well as the delivery of confidential information to the SFE. In this, he partially coincides with the MAG report, in the sense that it is the law that requires the issuance of the executive decree in question, for the establishment of requirements and procedures for the registration of chemical, biological and biochemical substances. He mentions opinion C-175-2005 of the PGR. Regarding the background, he refutes the claimant's assertions, since the executive decree subject to this action does not seek to grant more time to the business sector for the commercialization of agrochemicals. He considers that, rather, obligations to update information are imposed on these companies. He says that this is not a case of concurrent jurisdiction between the MAG, the Ministry of Health and MINAE, since law No. 7664 grants jurisdiction in matters of pesticide registration to the SFE. He adds that report DFOE-AM-19-2004 is inapplicable, contrary to what the claimant asserted. He reiterates what was said by the MAG, regarding the so-called principle of non-repetition of studies and insofar as the dispute should be settled in the legality venue and not the constitutional one. He reproduces the argument sustained by said ministerial body to the effect that the decree subject to this process does not allow granting registrations for new products, as well as the argument of the consolidation of the legal situation derived from the registration. He rejects the statements made by the claimant through the conclusions present in the filing brief. He requests that the unconstitutionality action be dismissed. He provides as documents the aforementioned MAG report, as well as the legal personality of the association in question.

**8.-** By brief received at 13:22 hrs. on May 29, 2019, Mr. **Juan Rafael Lizano Sáenz**, identity card no. 1-0379-0262, in his capacity as president of the National Chamber of Agriculture and Agroindustry (CNAA), legal entity number 3-002-051316, presents a passive coadjuvancy in this process. After recounting the factual background, he indicates that his standing as a coadjuvant comes from the purpose of the CNAA, which groups producers, entrepreneurs, and entities of the agricultural and agroindustrial sector. He states that the association brings together different members from various actors in the agricultural sector, and that precisely from there his standing originates, since their commercial activity involves the registration and application of pesticides. He indicates that the process affects the interests of the different groups that make up said association, which confirms the sufficient legitimate interest for the purpose of admitting the passive coadjuvancy. After reiterating the claimant's arguments, he proceeds to begin his exposition regarding the inadmissibility of the unconstitutionality action. Firstly, he refers to the fact that the reform carried out through executive decree No. 41481-MAG was done in compliance with what is stipulated in technical and scientific studies, according to international standards. Regarding the opinion of other bodies such as the PGR and MINAE, he indicates that this Constitutional Court cannot assess strictly technical matters and cites in his favor resolution No. 7009-2019. He insists that when dealing with the assessment of the validity of technical and scientific studies in environmental matters, the appropriate course is for it to be discussed in a venue other than the constitutional one and invokes resolutions numbers 6922-2008 and 7009-2019. He alleges that such assessments fall outside the summary procedure of amparo. Furthermore, he refers to the power granted by different legal and regulatory norms, as well as constitutional ones, to the Executive Branch in the strict sense for the promulgation of executive decrees and, since said norms grant competence to the MAG, they do so to the exclusion of other bodies, for which reason he rejects the arguments of the claimant. He requests that the coadjuvancy be admitted and that the present unconstitutionality action be dismissed on the merits. He attaches the certification of his legal personality.

**9.-** By brief received at 14:50 hrs. on May 29, 2019, Mr. **Federico Lizano González**, identity card no. 1-0793-0229, in his capacity as legal representative of the Chamber of Agricultural Inputs of Costa Rica, legal entity number 3-002-045217, proceeds to file a passive coadjuvancy in this process. Regarding his standing as a coadjuvant, he maintains that his client is an organization formed by companies in the sector supplying inputs and technology for the agricultural sector, hence the validity of executive decree No. 41481-MAG directly affects the interests of the Chamber and its affiliates. The foregoing insofar as its members carry out registration procedures for agricultural inputs and indicates that what this Constitutional Court resolves directly affects the activities of the Chamber and its members. As to the merits of the matter, he considers that the action should be dismissed. He mentions that the regulatory power held by the Executive Branch has constitutional status, and that it is not subject to any limits other than legal regularity and the reservation of law. On the other hand, he alleges that registrations by incorporation and by equivalence are based on the rationalization of state intervention; that resorting to this information obtained from high standards does not endanger the environment or health. He maintains that the decree in question refers to products that are already on the market and that were already duly evaluated. Regarding the reduction of deadlines, he considers that said norm is not contrary to constitutional Law, as it fits within the framework of regulatory improvement and better provision of public service. He requests that the coadjuvancy be admitted and that the present unconstitutionality action be dismissed in all its aspects.

**10.-** By brief received at 14:40 hrs. on May 29, 2019, Mr. **Manrique Constela Umaña**, in his capacity as unlimited general attorney-in-fact of Polymer S.A., presents a passive coadjuvancy in the present constitutionality process. To support his standing as a coadjuvant, he indicates that the company is dedicated to the production of plastic packaging for industry, agriculture, and personal consumption. He affirms that the legitimate interest in relation to this action derives from the fact that they must frequently request the registration or revalidation of agrochemical or agrobiological products. Regarding the merits of the matter, they request that the unconstitutionality action be summarily rejected, since they do not consider that it meets the admissibility requirements. He considers that the interest pursued by the claimant is individual and direct and that in truth he does not act in defense of the environment or the right to health. He mentions that in fact the claimants seek to attack norms that they consider contrary to their economic interests and cites in defense of his arguments various resolutions of the Constitutional Court, including resolution No. 8470-2007. He considers that the claimant lacks active standing in this process and that therefore it must be summarily rejected. On the other hand, he maintains that the brief lacks adequate substantiation as it proceeds to reiterate the arguments already raised in the process handled under file 18-19039-0007-CO. In another vein, he suggests that this process be joined to the one being processed in said file and indicates that the challenged norms should not be suspended, as the claimant requested. The brief then refers to the constitutionality of the norms in question. Firstly, he reiterates what has already been said about the constitutional assignment of regulatory power to the Executive Branch, which he supports with doctrinal citations. He points out that in accordance with law No. 7664, it is up to the MAG to regulate said law, due to the organizational and technical structure it must have. He explains the scope of the principle of legality and its relationship with competence, based on doctrine and opinions of the PGR, applying the foregoing to the competence in phytosanitary matters and under the Phytosanitary Protection Law. He indicates that the SFE has the technical specialty for the development of its powers related to the control of chemical, biological or related substances for agricultural use. He points out that only the MAG has the competence to issue an adequate opinion on the registration or revalidation of products for agricultural use. He dismisses the claimant's criticisms that the decree subject to this process benefits producers, since rather he considers that it conforms to the principles of public service, for which he brings up Art. 4 of LGAP and resolution 5600-2005 of this Constitutional Court. He mentions that in no way does the reduction of deadlines imply favoring companies that sell agrochemicals; on the contrary, it obeys the technical criterion held by the SFE, in accordance with the principles of effectiveness, efficiency, and promptness. The application of law No. 8220 complements said argumentation. He considers that the reduction of deadlines is not contrary to the fundamental rights of health and environmental protection, which he supports with jurisprudence of this jurisdictional body. He points out in this brief that the elimination of requirements is not unconstitutional, as it reveals a lag in the technical regulations in question, derived from what he considers a poor conception of environmental and sanitary protection. He exposes the difference between formulated pesticide and technical-grade active ingredient, as well as the distinction between registration by incorporation and registration by equivalence, and alleges that the decree in question does not eliminate necessary requirements for the protection of health or the environment, but rather establishes rational regulations consistent with the great public utility derived from the registration of agrochemical products. He requests that the action be summarily dismissed and, should this request not be granted, that it be joined to file No. 18-19039-0007-CO. He also requests that the unconstitutionality action be dismissed in all its aspects, as well as an interpretation of the decree in question in conformity with the Political Constitution, in case the Constitutional Court considers that the application of the decree in question violates constitutional norms and principles.

**11.-** The Presidency of the Constitutional Court, through the resolution of 15:48 hrs. on May 30, 2019, resolved the matters pertaining to the coadjuvancies:

*"In the specific case, the petitioner Enrique García González, appeared on May twenty, two thousand nineteen, however, he was unable to prove his interest to appear as a coadjuvant in the present matter, hence his request cannot be deemed accepted, in accordance with the provisions of Article 83 of the Law of Constitutional Jurisdiction.* *On the other hand, the coadjuvants Constenla Umaña, Osborne Escalante, Lizano González and Lizano Saénz, appeared on May twenty-ninth, two thousand nineteen and request to be considered as coadjuvants because they consider that what is resolved in the present unconstitutionality action may eventually have an impact on their commercial activities. Consequently, and given that the first publication of the notice was on May eighth, two thousand nineteen, the appropriate course is to consider them as coadjuvants in this matter."* Likewise, the hearings granted to the PGR and the MAG were deemed as answered.

**12.-** By brief signed on August 27, 2019, the Minister of Agriculture and Livestock, **Luis Renato Alvarado Rivera,** requested clarification of the order of 14:45 hrs. of April 08, 2019, regarding the effects on the administrative procedures for updating the registration files. Likewise, he insists on the following:

*"We do not omit to express to the Honorable Court, that the challenged norm does not refer to new registrations to be granted, but to an update of the information of current registrations, which were granted in the past, after having passed the evaluation of the ministries of Agriculture and Health. Furthermore, it does not refer to products that were first authorized in Costa Rica worldwide, but rather those that had already been comprehensively evaluated (in the agronomic, health and environmental aspects) and approved by regulatory entities in their countries of origin, such as the United States of America, the European Union, Japan, among others.* *The update proposed in the challenged norm rather serves to organize the national regulatory system, since it orders bringing the original information in the files of current registrations up to date."* **13.-** By brief filed on November 1, 2019 (without the corresponding signature) Mr. Henry José Picado Cerdas, identity card no. 3-0403-0272, in his capacity as an interested citizen, proceeds to request appearance in the present process.

**15.-** The legal requirements have been fulfilled in the proceedings.

Drafted by Magistrate **Garro Vargas;** **WHEREAS** **I.- REGARDING THE LAST COADJUVANCY PETITION** A document lacking a signature was filed in a memorial received at the Secretariat of the Court on November 1, 2019, supposedly subscribed by Mr. Henry José Picado Cerdas, identity card no. 3-0403-0272. He only stated that in his capacity as an interested citizen he requested appearance in the present process. Said petition is inadmissible for several reasons. As already noted, the document lacks a physical or digital signature that allows corroborating the validity of the petition in a process that is of a formal nature like the unconstitutionality action. Secondly, the party does not provide reasons for his desire to appear in the process and, finally, if it is considered to be a coadjuvancy, it was filed untimely. Therefore, the petition is rejected.

**II.- REGARDING THE ADMISSIBILITY OF THE UNCONSTITUTIONALITY ACTION. STANDING** Regarding this matter, it must be noted that Art. 75 paragraph 2 of the Law of Constitutional Jurisdiction (LJC) establishes that a pending prior case will not be necessary when, due to the nature of the matter, there is no individual and direct injury, or it concerns the defense of diffuse interests, or those that concern the community as a whole. In this sense, the Constitutional Court, in its judgment No. **2001-8239**, referred to diffuse interests, in the following terms:

*"In accordance with the first of the cases provided for by paragraph 2 of article 75 of the Law of Constitutional Jurisdiction, the challenged norm must not be susceptible to concrete application, which would later allow the challenge of the applicative act and its consequent use as a base matter.* (...) Secondly, the possibility of acting in defense of diffuse interests (intereses difusos) is foreseen. (...) Diffuse interests, although difficult to define and even more difficult to identify, cannot be, in our law —as this Chamber has already stated— merely collective interests; nor so diffuse that their ownership is confused with that of the national community as a whole, nor so concrete that, in relation to them, specific individuals, or personalized groups, are identified or easily identifiable, whose standing (legitimación) would derive, not from diffuse interests, but from the corporate interests that concern a community as a whole. Therefore, they are individual interests, but at the same time, diluted in more or less extensive and amorphous groups of people who share an interest and, therefore, suffer an actual or potential injury, more or less equal for all, which is why it is rightly said that they are equal interests of the groups that find themselves in certain circumstances and, at the same time, of each one of them. That is, diffuse interests partake of a dual nature, as they are simultaneously collective —for being common to a generality— and individual, which is why they can be claimed in such capacity. (...) In sum, diffuse interests are those whose ownership belongs to groups of people not formally organized, but united based on a specific social need, a physical characteristic, their ethnic origin, a specific personal or ideological orientation, the consumption of a certain product, etc.” In the present matter, the plaintiff asserts his standing via abstract constitutional review (control abstracto de constitucionalidad) and invokes the defense of diffuse interests, given that he acts to safeguard the right to a healthy and balanced environment and the population's right to health, related to the registration of pesticides that evidently impact these rights. Consequently, such circumstance confers upon the petitioner direct standing for the filing of the present proceeding, by invoking the defense of interests that concern the national community as a whole.

By reason of the foregoing, the hearing and resolution of the present unconstitutionality action via abstract review is admissible.

**III.- ON THE OBJECT OF THE ACTION** This action aims to resolve the grievances of unconstitutionality raised against Executive Decree No. 41481-MAG, called "Reforma Reglamento para la actualización de la información de los expedientes de registro de ingrediente activo grado técnico y plaguicidas formulados". Due to the length of the rule, its complete content is not cited here; rather, the provisions will be transcribed and the grievances will be addressed specifically in the respective recital.

In general terms, it is alleged that the decree implies a benefit to pesticide marketers, since it extends the time to five years without said products having to undergo a risk assessment. It is alleged that this type of decree only seeks to give more time to agrochemical selling companies so that they continue with the process of marketing and using substances that are dangerous and that can cause serious harm to the health of the Costa Rican population, affect biodiversity, and damage the environment, since the registrations have not been integrally evaluated. In other words, that the products in question do not have a chronic toxicology study and none of these registrations has undergone an ecotoxicological assessment, and many may not be effective at the doses for which they were registered. Furthermore, that the decree lacks a technical basis on the subject of pesticides and seeks to relax requirements, to the detriment of people's lives and health. The issue of the deadlines provided for the submission and resolution of procedures is questioned, and that the authorities of the Ministry of Health and MINAE were excluded from the process.

Previously (see judgment No. 2022-026651), this Chamber noted that, in the interim of the processing of this action, new executive decrees were issued that could have an impact on the validity of this regulation. Specifically, in Executive Decree No. 43469 of April 6, 2022, “RTCR 504:2021. Reglamento para el Registro de Insumos Agrícolas. Plaguicidas Sintéticos Formulados, Ingrediente Activo Grado Técnico, Coadyuvantes, Sustancias afines y Vehículos Físicos de Uso Agrícola," two transitory rules were established providing that the Executive Branch will promulgate a new specific technical regulation governing the updating of registrations:

*“TRANSITORIO 5. The Executive Branch, within six months from the date of entry into force of this regulation, shall promulgate a specific technical regulation governing the updating of registrations of technical grade active ingredient and formulated synthetic pesticides, granted based on a regulatory body other than this regulation, Executive Decree No. 33495 MAG-SMINAE-MEIC "Reglamento sobre Registro, Uso y Control de Plaguicidas Sintéticos Formulados, Ingrediente Activo Grado Técnico, Coadyuvantes y Sustancias Afines de Uso Agrícola" or Executive Decree No. 42769-MAG-S-MINAE "Reglamento para optar por el Registro de Ingrediente Activo Grado Técnico mediante el reconocimiento de la evaluación de los estudios técnicos aprobados por las Autoridades Reguladoras de los países miembros de la OCDE y los países adherentes de la OCDE". This technical regulation must at least consider the requirements, procedures, the prioritization of the updating, the deadlines in accordance with the capacities of the AC and the competent reviewing authorities, as well as the technical establishment of reference profiles for the evaluation of all those products that were registered under regulations different from those cited. The registrant may refer to information already submitted in previous processes of revalidation, updating, or renewal where applicable.* *TRANSITORIO 6. Registrations granted based on a regulatory body other than this regulation, Executive Decree No. 33495 MAG-SMINAE-MEIC "Reglamento sobre Registro, Uso y Control de Plaguicidas Sintéticos Formulados, Ingrediente Activo Grado Técnico, Coadyuvantes y Sustancias Afines de Uso Agrícola" or Executive Decree No. 42769-MAG-S-MINAE "Reglamento para optar por el Registro de Ingrediente Activo Grado Técnico mediante el reconocimiento de la evaluación de los estudios técnicos aprobados por las Autoridades Reguladoras de los países miembros de la OCDE y los países adherentes de la OCDE", must carry out the updating in accordance with the regulation established for these purposes pursuant to Transitorio 5. These registrations shall be considered valid for a period of five years from the entry into force of this regulation. This period shall be deemed extended for an equal period for the procedures that have been submitted for updating in accordance with the regulation indicated in Transitorio 5 if, upon the expiration thereof, the competent reviewing authorities have not yet completed the review of the updating procedures.”* Additionally, it is noted that through Executive Decree No. 43838-MAG-S-MINAE, a technical regulation was actually issued called “RTCR 509:2022. Insumos Agrícolas. Plaguicidas Sintéticos Formulados, Ingrediente Activo Grado Técnico, Coadyuvantes, Vehículos Físicos y Sustancias Afines de Uso Agrícola. Registro” published in the Official Gazette La Gaceta No. 253, Alcance No. 278 dated December 21, 2022 (https://www.imprentanacional.go.cr/pub/2022/12/21/ALCA278_21_12_2022.pdf), in which it was ordered to repeal Executive Decree No. 39995-MAG of December 15, 2016, “Reglamento para la actualización de la información de los expedientes de registro de ingrediente activo grado técnico y plaguicidas formulados" and its reform, published in Alcance No. 10 of January 16, 2017” (reformed by Decree No. 41481-MAG, the object of this action). Said regulation will take effect as of March 21, 2023, so the repeal will become effective at that time.

Consequently, the challenges to constitutionality remain in force. </span></p><p style="margin-top:0pt; margin-bottom:0pt; text-align:justify; line-height:150%; font-size:14pt"><span style="font-family:'Times New Roman'; font-weight:bold">IV.- ON PHYTOSANITARY PROTECTION, CONSTITUTIONAL FOUNDATION</span></p><p style="margin-top:0pt; margin-bottom:0pt; text-align:justify; line-height:150%; font-size:14pt"><span style="font-family:'Times New Roman'">First, it is worth emphasizing that phytosanitary protection measures have their foundation in our Social State of Law (Estado Social de Derecho), insofar as they simultaneously seek to safeguard values of great constitutional significance: health (art. 21), the protection of consumer rights, specifically to health and the environment (art. 46), as well as the stimulation of agricultural production, so important for our country, in parallel with the protection of the environment (art. 50), and such were the constitutional principles that the legislator took into consideration when enacting the Phytosanitary Protection Law (Ley de Protección Fitosanitaria). This has been recognized by this Court in multiple rulings. For example, in judgment </span><span style="font-family:'Times New Roman'; font-weight:bold">No. 2009-013606</span><span style="font-family:'Times New Roman'"> the Chamber made the following considerations:</span></p><p style="margin-top:0pt; margin-left:28.35pt; margin-bottom:0pt; text-align:justify"><span style="font-family:'Times New Roman'; font-style:italic; color:#010101">"Article 1 of the</span><span style="font-family:'Times New Roman'; font-style:italic; color:#010101"> </span><span style="font-family:'Times New Roman'; font-style:italic; color:#010101">Phytosanitary Protection Law (Ley de Protección Fitosanitaria)</span><span style="font-family:'Times New Roman'; font-style:italic; color:#010101"> </span><span style="font-family:'Times New Roman'; font-style:italic; color:#010101">clearly states: 'The phytosanitary protection measures established in this law and its regulations are declared to be of public interest and mandatory application.' </span></p><p style="margin-top:0pt; margin-left:28.35pt; margin-bottom:0pt; text-align:justify"><span style="font-family:'Times New Roman'; font-weight:bold; font-style:italic; text-decoration:underline; color:#010101">Said law addresses principles and needs fundamental to the stability of the country, such as food security and economic activity based on agricultural production.</span><span style="font-family:'Times New Roman'; font-style:italic; color:#010101"> This finds its basis in several articles of our Political Constitution. Thus, in accordance with article 50, 'the State shall seek the greatest well-being for all inhabitants of the country, organizing and stimulating production and the most adequate distribution of wealth.' Furthermore, according to this norm, it must guarantee, defend, and preserve every person's right to a healthy and ecologically balanced environment, for which the law shall determine the corresponding responsibilities and sanctions. On the other hand, from article 21 of the Political Constitution, which enshrines the inviolability of human life, derives the right to health, to the physical, mental, and social well-being of persons, and the State's obligation to protect them (Sala Constitucional, Voto No. 3705-93 of 3:00 p.m. on July 30, 1993). Likewise, article 46 in fine enshrines the right of all consumers and users to the protection of their health, environment, security, and economic interests. Such were the constitutional principles that the legislator took into consideration when enacting the</span><span style="font-family:'Times New Roman'; font-style:italic; color:#010101"> </span><span style="font-family:'Times New Roman'; font-style:italic; color:#010101">Phytosanitary Protection Law (Ley de Protección Fitosanitaria), No. 7664 of April 8, 1997. Among its main objectives are to avoid and prevent the introduction and spread of pests, to protect plants from the damages caused by them, to regulate their combat, to promote integrated pest management within sustainable development programs, to regulate the use and management of chemical, biological, or related substances and the equipment to apply them in agriculture, as well as to prevent phytosanitary measures from constituting an unnecessary obstacle to international trade (article 2).</span></p><p style="margin-top:0pt; margin-left:28.35pt; margin-bottom:0pt; text-align:justify"><span style="font-family:'Times New Roman'; font-style:italic; color:#010101">The Law provides a special procedure for addressing phytosanitary emergencies that may compromise food security and the country's economy, and grants the Administration certain powers to adopt all measures necessary to control a situation of that nature. If it is the State's constitutional duty to organize national production, it follows, therefore, that it is also its duty to design mechanisms for controlling pests that may negatively affect it, for which different techniques are employed, such as the declaration of quarantines, the destruction of plants, the control of entry and country of origin of plants or biological control agents, integrated pest management, among others. In this sense, the combat of pests must be a shared effort between the State and the private individuals involved in a situation of this nature. However, if in a specific situation the private individual does not comply with the guidelines issued by the State Phytosanitary Service (Servicio Fitosanitario del Estado) for combating a pest, the Administration not only can but is obligated to substitute for them and execute the necessary control works that allow for the timely containment of existing infection foci. Now then, this conduct by the Administration should not generate any property liability for it, since it is motivated precisely by the omission of the private individual, who is the first called upon to combat the infectious situation in accordance with the instructions issued for this purpose by the Phytosanitary Service (Servicio Fitosanitario). This is the reason that justifies the exemption from liability established by the challenged article 15. The protection of public order is above individual interest, but it is the negligence of the private individual that justifies that, even though the Administration's action causes them exceptionally intense damage, there is no legal basis to claim any compensation from the State, especially considering that this negligence may not only affect them, but may also compromise the well-being and general interest of society.</span></p><p style="margin-top:0pt; margin-left:28.35pt; margin-bottom:0pt; text-align:justify"><span style="font-family:'Times New Roman'; font-style:italic; color:#010101">The negligence and omission of the private individual then obligate the Administration to deploy its police power (poder de policía) in order to protect the public social interest. When we speak of 'police power' in a broad sense, we refer to that set of measures aimed at protecting public safety, morality, and health (salubridad pública), as well as the defense and promotion of the economic interests of the community and its general well-being. It manifests, in principle, as a power attributed to the legislative power and is therefore non-delegable. However, the legislator can create in ordinary law an imputation of functions, assigning to the executive power, for example, the authority to regulate certain matters, within the limits pre-established by law; this is what occurs in the present case. The</span><span style="font-family:'Times New Roman'; font-style:italic; color:#010101"> </span><span style="font-family:'Times New Roman'; font-style:italic; color:#010101">Phytosanitary Protection Law (Ley de Protección Fitosanitaria) grants the Executive Power, through the Ministry of Agriculture and Livestock, the necessary powers to control possible foci of infection and/or pests." </span><span style="font-family:'Times New Roman'; color:#010101">(The emphasis does not belong to the original). </span></p><p style="margin-top:0pt; margin-bottom:0pt; text-align:justify; line-height:150%; font-size:14pt"><span style="font-family:'Times New Roman'; -aw-import:ignore"> </span></p><p style="margin-top:0pt; margin-bottom:0pt; text-align:justify; line-height:150%; font-size:14pt"><span style="font-family:'Times New Roman'">Along the same lines, this Court has been aware that the chemical components for containing pests in agricultural products have a clear and notable impact on the environment (the saturation and fertilization of soils), but also on food security (access to food) and, therefore, it is necessary for the State to assume a proactive and vigilant conduct in the matter. Indeed, the State has the obligation to </span><span style="font-family:'Times New Roman'">regulate the use of chemical or related substances for agricultural use, so that they are</span><span style="font-family:'Times New Roman'"> </span><span style="font-family:'Times New Roman'">managed correctly, reasonably, and do not generate risks to human health and the environment. Furthermore, it has the responsibility to guarantee the well-being of the inhabitants and an ecologically balanced environment. In judgment </span><span style="font-family:'Times New Roman'; font-weight:bold">No. 2021-019096</span><span style="font-family:'Times New Roman'"> the following was decided:</span></p><p style="margin-top:0pt; margin-left:28.35pt; margin-bottom:0pt; text-align:justify"><span style="font-family:'Times New Roman'; font-style:italic">"</span><span style="font-family:'Times New Roman'; font-weight:bold; font-style:italic">VI.- ON THE REGULATION OF PESTICIDE USE</span><span style="font-family:'Times New Roman'; font-weight:bold; font-style:italic"> </span><span style="font-family:'Times New Roman'; font-style:italic">As indicated</span><span style="font-family:'Times New Roman'; font-style:italic"> </span><span style="font-family:'Times New Roman'; font-style:italic">above, the right to life, health, and a healthy environment are fundamental rights regulated in articles 21 and 50 of the Political Constitution, and their protection is of public interest. Precisely, it is for this reason that the State has the obligation, in order to protect the health of the population and the environmental precautionary principle, to regulate the use of chemical or related substances for agricultural use, so that they are</span><span style="font-family:'Times New Roman'; font-style:italic"> </span><span style="font-family:'Times New Roman'; font-style:italic">managed correctly, reasonably, and do not generate risks to human health and the environment. Furthermore, it also has the responsibility to guarantee the well-being of citizens and an ecologically balanced environment. Regarding this, the Chamber has established that the State must play the role of guarantor with respect to the proper use of pesticides and the avoidance of their harmful effects on health and the environment. In this regard, in Judgment No.</span><span style="font-family:'Times New Roman'; font-style:italic"> </span><span style="font-family:'Times New Roman'; font-style:italic">2004-13968 of 11:35 a.m. on December 3, 2014, it stated:</span></p><p style="margin-top:0pt; margin-left:28.35pt; margin-bottom:0pt; text-align:justify"><span style="font-family:'Times New Roman'; font-style:italic">"III.- That report [FOE-AM-19/2004 of October 20, 2004, prepared by the</span><span style="font-family:'Times New Roman'; font-style:italic"> </span><span style="font-family:'Times New Roman'; font-style:italic">Area of agricultural services and environment of the Division of operational and evaluative oversight of the Office of the Comptroller General of the Republic, on the evaluation of the State's management regarding the control of agricultural pesticides] originated</span><span style="font-family:'Times New Roman'; font-style:italic"> </span><span style="font-family:'Times New Roman'; font-style:italic">from the need to oversee the administrative process related to one of the most pressing environmental problems the country must resolve, which is the use of chemical, biological, or related substances in agricultural activities, and given the need for the State to intervene by exercising a regulatory function over the use of agricultural chemicals (agroquímicos), which guarantees farmers the availability on the market of effective products for combating pests and, at the same time, the protection of the health of citizens in general and their right to a healthy and ecologically balanced environment. It was indicated</span><span style="font-family:'Times New Roman'; font-style:italic"> </span><span style="font-family:'Times New Roman'; font-style:italic">in the report that this control is exercised mainly by the Ministry of Agriculture and Livestock, through the State Phytosanitary Service (Servicio Fitosanitario del Estado), which must work in coordination with the Ministry of Health and the Ministry of Environment and Energy, regarding the control of impacts on health and the environment, as well</span><span style="font-family:'Times New Roman'; font-style:italic"> </span><span style="font-family:'Times New Roman'; font-style:italic">as with the Ministry of Finance regarding the importation and exoneration of such products. Its general objective was to evaluate the State's management regarding the control of pesticides used in agricultural activities and their effect on the environment and human health, mainly the actions of the State Phytosanitary Service (Servicio Fitosanitario del Estado) of the Ministry of Agriculture and Livestock (MAG); and the specific objectives of the study were: a) to evaluate national policies and stewardship in the field of pesticide use control, identifying the participating institutions and their competencies, b) to evaluate the process of pesticide registration in the country and the associated regulations, c) to evaluate the process of exoneration and importation of pesticides in the country, and d) to evaluate the oversight and monitoring of pesticide use.</span></p><p style="margin-top:0pt; margin-left:28.35pt; margin-bottom:0pt; text-align:justify"><span style="font-family:'Times New Roman'; font-style:italic">IV.- In that report, the Office of the Comptroller General concluded</span><span style="font-family:'Times New Roman'; font-style:italic"> </span><span style="font-family:'Times New Roman'; font-style:italic">that the State Phytosanitary Service (SFE) does not fulfill its creation objectives efficiently and with adherence to the principle of legality, which call upon it to regulate, execute, and oversee the registration and use of agricultural chemicals, within the framework of agricultural activity in harmony with nature and with faithful compliance with the constitutional principles of the right to life, health, and a healthy environment. It determined</span><span style="font-family:'Times New Roman'; font-style:italic"> </span><span style="font-family:'Times New Roman'; font-style:italic">that, on the contrary, the actions of said</span><span style="font-family:'Times New Roman'; font-style:italic"> </span><span style="font-family:'Times New Roman'; font-style:italic">body are oriented towards facilitating the registration and commercialization of such substances, justified by a supposed interest in improving the competitiveness of agricultural producers, but rather, those objectives seem to be directed at fostering competition in the pesticide market, above the constitutional rights of the same farmers and the environmental and health principles of the people. It concluded</span><span style="font-family:'Times New Roman'; font-style:italic"> </span><span style="font-family:'Times New Roman'; font-style:italic">that the companies most benefited by the facilitating function of the SFE have been the companies dedicated to the sale of agricultural chemicals, especially those denominated generics, to the detriment of producers and consumers of agricultural goods. It clarified</span><span style="font-family:'Times New Roman'; font-style:italic"> </span><span style="font-family:'Times New Roman'; font-style:italic">that this does not mean that pesticides of this type cannot be registered in the country, but rather that their registration must be done respecting the regulations and ensuring the Costa Rican population the protection of their health and the fundamental right they have to a healthy and ecologically balanced environment, and protecting for the national farmer their right to have good quality inputs; without prejudice to the necessary actions that the State must execute to seek the gradual reduction of pesticide use and the promotion of alternative mechanisms. These considerations motivated the Office of the Comptroller General of the Republic to issue a series of final dispositions addressed to the President of the Republic and the Ministers of National Planning and Economic Policy, Agriculture and Livestock, Health, Environment and Energy, and Economy, Industry and Commerce, as well</span><span style="font-family:'Times New Roman'; font-style:italic"> </span><span style="font-family:'Times New Roman'; font-style:italic">as to the Internal Auditor of the Ministry of Agriculture and Livestock."</span></p><p style="margin-top:0pt; margin-left:28.35pt; margin-bottom:0pt; text-align:justify"><span style="font-family:'Times New Roman'; font-style:italic">Similarly, in Judgment No.</span><span style="font-family:'Times New Roman'; font-style:italic"> </span><span style="font-family:'Times New Roman'; font-style:italic">2006-09565, of 4:08 p.m. on July 5, 2006, this Court considered:</span></p><p style="margin-top:0pt; margin-left:28.35pt; margin-bottom:0pt; text-align:justify"><span style="font-family:'Times New Roman'; font-style:italic">"</span><span style="font-family:'Times New Roman'; font-style:italic"> </span><span style="font-family:'Times New Roman'; font-style:italic">(…</span><span style="font-family:'Times New Roman'; font-style:italic"> </span><span style="font-family:'Times New Roman'; font-style:italic">)</span><span style="font-family:'Times New Roman'; font-style:italic"> </span><span style="font-family:'Times New Roman'; font-style:italic">it is evident that the Costa Rican State is</span><span style="font-family:'Times New Roman'; font-style:italic"> </span><span style="font-family:'Times New Roman'; font-style:italic">under the duty to act effectively and in advance to prevent the occurrence of events that degrade the environment and compromise its sustainability."</span></p><p style="margin-top:0pt; margin-left:28.35pt; margin-bottom:0pt; text-align:justify"><span style="font-family:'Times New Roman'; font-style:italic">And, in No.</span><span style="font-family:'Times New Roman'; font-style:italic"> </span><span style="font-family:'Times New Roman'; font-style:italic">2011-016937 of 2:36 p.m. on December 7, 2011, it ordered:</span></p><p style="margin-top:0pt; margin-left:28.35pt; margin-bottom:0pt; text-align:justify"><span style="font-family:'Times New Roman'; font-style:italic">"</span><span style="font-family:'Times New Roman'; font-style:italic"> </span><span style="font-family:'Times New Roman'; font-style:italic">(…) VIII.- ON THE REGULATION REGARDING PESTICIDE REGISTRATION. The proper use of pesticides can be</span><span style="font-family:'Times New Roman'; font-style:italic"> </span><span style="font-family:'Times New Roman'; font-style:italic">useful for the control and elimination of pests, for the benefit of the food security of the population</span><span style="font-family:'Times New Roman'; font-style:italic"> </span><span style="font-family:'Times New Roman'; font-style:italic">and of the economic activity based on agricultural production. However, the potential risk that the use of such substances may entail for human health and the environment must be recognized. This has even motivated the adoption of international instruments with the express objective of protecting human health —including the health of consumers and workers— and the environment against the possible harmful effects of pesticides, as is the case of the Rotterdam Convention on the Prior Informed Consent Procedure for Certain Hazardous Chemicals and Pesticides in International Trade, which was approved by Costa Rica, through Law No. 8705 of February 13, 2009.</span></p><p style="margin-top:0pt; margin-left:28.35pt; margin-bottom:0pt; text-align:justify"><span style="font-family:'Times New Roman'; font-style:italic">(…</span><span style="font-family:'Times New Roman'; font-style:italic"> </span><span style="font-family:'Times New Roman'; font-style:italic">) this Court has recognized the risk that the use of pesticides may entail and the importance of adopting suitable measures to regulate their use. In the Costa Rican legal system, there is diverse legal and regulatory normativity from which it derives that the activity of importing, manufacturing, commercializing, and using pesticides is</span><span style="font-family:'Times New Roman'; font-style:italic"> </span><span style="font-family:'Times New Roman'; font-style:italic">strongly subject to the State's police power (potestad de policía), in order to guarantee the right to health and to a healthy and ecologically balanced environment."</span><span style="font-family:'Times New Roman'"> (Considerations that were reiterated in judgment </span><span style="font-family:'Times New Roman'; font-weight:bold">No. 2021-024807</span><span style="font-family:'Times New Roman'">). </span></p><p style="margin-top:0pt; margin-bottom:0pt; text-align:justify; line-height:150%; font-size:14pt"><span style="font-family:'Times New Roman'; -aw-import:ignore"> </span></p><p style="margin-top:0pt; margin-bottom:0pt; text-align:justify; line-height:150%; font-size:14pt"><span style="font-family:'Times New Roman'">Echoing these constitutional principles, legal regulations declared to be of public interest by the legislator have been issued to address this important matter. For example, the aforementioned </span><span style="font-family:'Times New Roman'; background-color:#ffffff">Phytosanitary Protection Law (Ley de Protección Fitosanitaria) in art. 1 provides that it is declared "of public interest and mandatory application, the phytosanitary protection measures established in this law and its regulations"; the General Health Law (declared of public interest in art. 7) also contains general provisions regarding the management of these substances; and the Law on the Use, Management, and Conservation of Soils (also of public interest by virtue of the provisions expressly set forth in arts. 3 and 61 of the law) includes provisions and competencies in favor of MINAE regarding activities that may cause soil contamination (see art. 28 et seq.). </span></p><p style="margin-top:0pt; margin-bottom:0pt; text-align:justify; line-height:150%; font-size:14pt"><span style="font-family:'Times New Roman'; background-color:#ffffff">In this way, a very broad scope of action for the Costa Rican State is observed regarding the use of agricultural chemicals, which includes regulating both the use and management of chemical, biological, or related substances and equipment for applying them in agriculture, as well as their registration, importation, quality, and residues, while simultaneously seeking to protect human health and the environment. </span></p><p style="margin-top:0pt; margin-bottom:0pt; text-align:justify; line-height:150%; font-size:14pt"><span style="font-family:'Times New Roman'; background-color:#ffffff">Regarding the object of this unconstitutionality action, the topic of the "registration (inscripción)" of products is of particular interest, which is regulated in more detail in arts. 23, 24, and 25 of the Phytosanitary Protection Law (Ley de Protección Fitosanitaria). These establish registration and inscription (registro e inscripción) as one of the control mechanisms for establishments and inputs for agricultural use. Specifically, and of particular relevance to this unconstitutionality action, art. 23 of the law states the following:</span></p><p style="margin-top:0pt; margin-left:28.35pt; margin-bottom:0pt; text-align:justify"><span style="font-family:'Times New Roman'; font-style:italic; background-color:#ffffff">"Art. 23 - Registration (Inscripción) of substances and equipment</span></p><p style="margin-top:0pt; margin-left:28.35pt; margin-bottom:0pt; text-align:justify"><span style="font-family:'Times New Roman'; font-style:italic; background-color:#ffffff">According to the requirements to be specified in the regulation of this law, all chemical, biological, or related substances and application equipment for agricultural use must be registered (inscribirse) in the registry that the State Phytosanitary Service (Servicio Fitosanitario del Estado) will create to have information on the characteristics of these and to ensure their correct use in the country."</span></p><p style="margin-top:0pt; margin-left:28.35pt; margin-bottom:0pt; text-align:justify"><span style="font-family:'Times New Roman'; font-style:italic; -aw-import:ignore"> </span></p><p style="margin-top:0pt; margin-bottom:0pt; text-align:justify; line-height:150%; font-size:14pt"><span style="font-family:'Times New Roman'; background-color:#ffffff">As will be examined below, the regulations subject to action respond precisely to this obligation of the State, entrusted to the SFE, to keep the registry of substances used for agricultural use up to date. </span></p><p style="margin-top:0pt; margin-bottom:0pt; text-align:justify; line-height:150%; font-size:14pt"><span style="font-family:'Times New Roman'; font-weight:bold">V.- BACKGROUND IN THE CONSTITUTIONAL JURISDICTION </span></p><p style="margin-top:0pt; margin-bottom:0pt; text-align:justify; line-height:150%; font-size:14pt"><span style="font-family:'Times New Roman'">The matter under analysis has been examined from different angles by this Court. </span></p><p style="margin-top:0pt; margin-bottom:0pt; text-align:justify; line-height:150%; font-size:14pt"><span style="font-family:'Times New Roman'">In judgment </span><span style="font-family:'Times New Roman'; font-weight:bold">No. 2017-06668</span><span style="font-family:'Times New Roman'">, regarding the constitutionality of Executive Decree No. 39995-MAG (which was later reformed by the decree subject to this action), the following was decided:</span></p><p style="margin-top:0pt; margin-left:28.35pt; margin-bottom:0pt; text-align:justify"><span style="font-family:'Times New Roman'; font-style:italic">"</span><span style="font-family:'Times New Roman'; font-weight:bold; font-style:italic">ON THE MERITS. ABOUT THE ALLEGED VIOLATION OF THE RIGHT PROTECTED IN ARTICLE 50 OF THE POLITICAL CONSTITUTION, RELATING TO A HEALTHY AND ECOLOGICALLY BALANCED ENVIRONMENT. </span><span style="font-family:'Times New Roman'; font-style:italic">The plaintiff accuses the violation of the right protected in article 50 of the Political Constitution, specifically, of the precautionary principle and the reversal of the burden of proof in environmental matters, given that, on the one hand, the discussed regulations require the Administration to </span><span style="font-family:'Times New Roman'; font-style:italic">demonstrate the existence of an unacceptable risk </span><span style="font-family:'Times New Roman'; font-style:italic">to human health, the environment, or agriculture, in order for the registration of an active ingredient and formulated pesticides to be restricted or prohibited, despite the scope of the aforementioned principle and, on the other hand, the fact that, according to the challenged regulations, it is incumbent upon the Administration, and not upon the holder of the activity, to prove the existence of a risk to the aforementioned legal interests, when the principle in question demands the opposite. In this regard, article 7 of Executive Decree No. 39995-MAG, Regulation for updating the information of the registration dossiers of technical grade active ingredient and formulated pesticides (which is, in essence, what the plaintiff challenges), stipulates the following: </span></p><p style="margin-top:0pt; margin-left:28.35pt; margin-bottom:0pt; text-align:justify"><span style="font-family:'Times New Roman'; font-style:italic">"</span><span style="font-family:'Times New Roman'; font-weight:bold; font-style:italic">ARTICLE </span><span style="font-family:'Times New Roman'; font-style:italic">7. During the period of validity of a registration, when the competent Ministries demonstrate an unacceptable risk to human health, the environment, or agriculture, the State Phytosanitary Service (Servicio Fitosanitario del Estado) will restrict or prohibit its use."</span> The regulation, per se, is intended to protect the environment and human health, specifically because it seeks to restrict or prohibit the use of a current registration when an unacceptable risk exists; consequently, far from harming these constitutional assets, it safeguards them. When proceeding with the registration of an active ingredient or pesticide is the appropriate time to apply the precautionary principle. It is presumed that during this registration procedure for a registration, the circumstance may arise where there is some technical or scientific doubt about the impact of the product on human health, the environment, or agriculture. It is at that moment of processing that the precautionary principle may be applied, meaning that, in the face of doubt, the administration must decide not to register a registration. **The challenged regulatory provision, that is, Article 7, refers to a stage subsequent to this, because it assumes that the registration procedure has already been substantiated, concluded, and the registration already exists. Consequently, to invalidate a previously processed registration, the demonstration of an unacceptable risk is required. On the other hand, as already indicated, the regulation is protective of human health and the environment, for which it contemplates a power of authority of the public administration, such as the restriction or prohibition of the use of a registration, even if a prior substantial legal situation exists in favor of the administered party, such as the registration.** **IV.- REGARDING THE VIOLATION OF THE PROVISIONS OF ARTICLE 146 OF THE POLITICAL CONSTITUTION. The Constitutional Chamber also does not consider that the omission of the Minister of Health and the Minister of the Environment to sign the Decree constitutes a defect of unconstitutionality of the questioned regulation, given that, as the plaintiff acknowledges, the challenged Decree has been issued jointly by the President of the Republic and the Minister of Agriculture, with which no affectation of the provisions of Article 146 of the Political Constitution is observed**, despite what the plaintiff claims on this matter. By virtue of the foregoing, the action must also be dismissed on its merits, as it pertains to this point." (The highlighting does not correspond to the original).

These considerations are especially significant for the specific case, as they make it clear that to invalidate an already authorized registration, it must be justified that there is a demonstration of an unacceptable risk to human health and the environment. Likewise, it was emphasized that the omission of the Minister of Health and the Minister of the Environment to sign the decree does not constitute a defect of unconstitutionality of the questioned regulation.

Subsequently, in judgment **no. 2017-007766,** the following was resolved:

**III.- SPECIFIC CASE.** Prior to the resolution of this amparo appeal, it must be indicated that the purpose of the amparo appeal is to provide timely protection against infringements or threats to fundamental rights and freedoms, not to serve as a generic instrument to guarantee the principle of constitutional supremacy or the principle of legality. For this reason, the Chamber cannot, through this means, establish itself as an abstract controller of the constitutionality of infra-constitutional norms. Hence, in accordance with subsection a) of numeral 30 of the Law governing this jurisdiction, amparo does not proceed in this case against laws or other normative provisions, except when they are challenged jointly with the acts of individual application of those, or when it involves norms of automatic action, in which case the procedure regulated in numerals 73 and following of the Law of Constitutional Jurisdiction must be followed. According to the cases just mentioned, amparo does not proceed in this case.

**IV.- NOTE BY MAGISTRATES CRUZ CASTRO AND RUEDA LEAL.** By resolution No. 2017006668 of 10:50 a.m. on May 10, 2017, an action of unconstitutionality against Executive Decree No. 39995-MAG, Regulation for the updating of information in the registration files of technical-grade active ingredient and formulated pesticides, was dismissed on its merits. In said judgment, Magistrates Cruz Castro and Rueda Leal dissented and ordered the action to proceed, because we considered that the matter warranted elucidation through the procedure of an action of unconstitutionality.

**V.- SEPARATE NOTE BY MAGISTRATE HERNÁNDEZ LÓPEZ.** I concur with the majority vote in this amparo appeal; however, I must expressly state that my position was to proceed with the action filed at the time by the interested parties regarding this matter. My reasons were the following:

"From my perspective, the decree establishes procedures to bring a group of pesticide registrations up to date with current technical requirements and assures those who manage to meet such conditions not only a new authorization period (Article 6), but also the guarantee (Article 7) that state authorities will not hinder their business except when they can demonstrate “an unacceptable risk to human health, the environment, or agriculture.” Read in this way (the one proposed by the plaintiff), the norm aims to provide the owners of the registrations with a guarantee against actions by the State regarding their products, but at the cost—according to the plaintiff—of sacrificing the precautionary principle, which holds constitutional rank.— I believe that the Costa Rican legal system obligates the State, constitutionally and conventionally, to protect public health, in such a way that if a person reasonably accredits a certain, real, and imminent risk to public health from the effects of a registered pesticide, the state authorities have the duty to act, regardless of whether that product is registered or not, because that registration could not be placed above a legal asset such as public health. History has documented major examples of pesticides such as Nemagon or DDT, which, despite having passed the tests and filters that existed at the time to guarantee their viability, turned out not to be innocuous for human health.

The challenged norm is inserted within a normative framework of protection at the constitutional and conventional level that obligates the authorities—even ex officio—to dictate the precautionary measures they deem necessary when a certain, real, and imminent injury to the health of the inhabitants is reasonably established, in such a way that the phrase “unacceptable risk” is not one that the administration must conclusively prove, or that imposes the burden of proof on the administered party, but rather one that—as indicated supra—is reasonably accredited from the concrete facts, protection for which the legal system provides, among other legal instruments, protection through the amparo appeal.

Similarly, with regard to the precautionary principle in environmental matters, this Constitutional Court has taken important steps, as seen, for example, in the doctrine that can be extracted from judgment No. 2004-1923 of 2:55 p.m. on February 25, 2004, where the postulate that absolute scientific certainty should not be used as a reason to postpone the adoption of cost-effective measures to prevent the degradation of the environment (...) is broadly developed.

The transcribed judgment is binding on state authorities in such a way that both the right to health and the precautionary principle in environmental matters obligate the State to act even in the face of mere risk, provided it is always clear that it is certain, real, and imminent, with which the discussed norm could not—and from my perspective does not—nullify the State's obligation to act to protect these legal assets, an action that is supported by constitutional and conventional norms. In that sense, I do not believe the norm has, in itself, a wording that clashes with the indicated values, but if its application were to occur within a framework that threatens the mentioned assets, the legal system has—above said norm of mere regulatory value—the immediate precautionary remedies that the administered party can request to protect them, among them, the amparo appeal.

Consequently, for the reasons stated, I believe that the norm, in its content, can never per se nullify the constitutional and conventional obligation that the State has in the protection of health and the environment.” I hereby clarify my position in that case and the reasons why I now agree with the majority." Likewise, the Chamber referred to the constitutionality of decree no. 40059-MAG-MINAE-S, “RTCR 484:2016. Agricultural Inputs, Synthetic Formulated Pesticides, Technical Grade Active Ingredient, Adjuvants, and Related Substances for Agricultural Use. Registration, Use and Control,” whose purpose was to regulate the registration process for synthetic formulated pesticides, technical-grade active ingredient, adjuvants, and related substances for agricultural use of the SFE. Its scope of application is constituted by the natural or legal persons that register, market, import, formulate, manufacture, repackage, re-containerize, store, distribute, and handle formulated chemical pesticides, technical-grade active ingredient, adjuvants, related substances, as well as those of mineral origin and inorganic salts. By vote **no. 2022-023238**, the majority dismissed the action of unconstitutionality. From what has been said, it is seen that said regulation was applicable for new registration processes.

On the other hand, in vote no. **2022-026651,** this court referred to the constitutionality of decree no. 39995-MAG, denominated “Regulation for the Updating of Information in the Registration Files of Technical-Grade Active Ingredient and Formulated Pesticides” and, by majority, the action of unconstitutionality was declared without merit. Said decree and the one being examined in the case file do not specifically refer to a process of registration or registry of new pesticides, but rather their regulation is applicable to products that are already on the market, but whose registration was carried out under other parameters that did not require the prior registration of the IAGT; therefore, the Executive Power deemed it essential to update the information of these registrations and also to establish a validity period equal to that of the registrations granted under the current regulation. Precisely in that constitutionality process, it was explained that decree no. 39995-MAG of December 15, 2016, is a regulation designed for updating the information in the registration files of technical-grade active ingredient (IAGT) and formulated pesticides. The regulation seeks to achieve the registration of all chemical, biological, or related substances for agricultural use, of old use in the SFE registry. This includes all those chemical entities not registered because the legislation did not establish it as a mandatory requirement. In this way, based on this Regulation, no IAGT and/or formulated product marketed in Costa Rica should be unknown to the State, and, even better, said regulation seeks to have the updated information that allows for better control. With it, it brings the technical and scientific information of old registrations up to date by associating the IAGTs with those registered under the rules under which they were registered. In this way, it opens the possibility for the State to have confidential chemical information, which is lacking in the files of the old registrations. Based on such premises, the constitutionality grievances formulated in the specific case will be examined below.

**VI.- ON LEGAL COMPETENCIES** In the first place, **the plaintiff** affirms that the Ministry of Health and MINAE must actively participate in this registration, post-registration, and revalidation or updating of pesticide information process, since the substances have a direct or indirect impact on the environment in general and consequently on people's health. He questions, therefore, that the decree grants SFE the power to grant registration unilaterally, without the participation of the other ministries, which in his view implies a setback in the level of protection and a violation of the principle of objectification of environmental protection.

The **Minister of Agriculture and Livestock** explained, in this regard, that the legal and technical norms relating to phytosanitary protection must be interpreted in accordance with the constitutional duty of the State and society in general to act in prevention of environmental risk and of both human and animal health, as is in fact done when issuing both executive decree no. 39995-MAG and no. 41481-MAG. He indicated that the legislator conferred on the SFE the competence to achieve the purposes contained in the Law on Phytosanitary Protection and that said competence assignment is exclusive to said entity, within which the carrying out and custody of the respective registrations falls. To this effect, the provisions of the Plant Health Law and the Law on Phytosanitary Protection are cited. In the latter, it expressly establishes the competence in matters of registration and oversight of pesticides for agricultural use in the SFE.

On this matter, the **PGR** stated that the challenged decree does not include the participation of the Ministry of Health and MINAE, and, therefore, carries the same defect as decree 39995, unless the Chamber considers that the competencies attributed to other entities in their respective founding laws are not repealed or modified by the challenged norm, and that the SFE – within the exercise of its legal competencies – can and must request the participation of any specialized technical entity to verify that a pesticide does not threaten health and the environment.

In this regard, **the Chamber** does not observe that it specifically constitutes an injury to the Law of the Constitution. The fact that the ordinary legislator has decided to concentrate phytosanitary protection competencies in a specific, legally created authority such as the SFE, attached to the MAG, does not in any way imply an injury to any provision of our Political Constitution. It corresponds to a specific organic and competence design decision that is freely configurable by the legislator and that, moreover, does not render ineffective the stewardship that the Ministry of Health or MINAE may have in matters within their competence. In this regard, the legislator provided broad competencies in favor of the SFE regarding precisely phytosanitary protection. To this effect, Art. 5 of the Law on Phytosanitary Protection, no. 7664, establishes the following:

"ARTICLE 5.- Functions and obligations The State Phytosanitary Service will have the following functions:

• a)Ensure the sanitary protection of plants.
• b)Advise on phytosanitary protection matters and recommend the issuance of the necessary legal norms in this field.
• c)**Coordinate with other ministries and their dependencies, the pertinent actions for the compliance with this Law and its Regulations.** It will be a coadjuvant and auxiliary entity of the General Directorate of Customs of the Ministry of Finance, in the oversight and control of the entry and values of merchandise or products of an agricultural nature.

(Thus amended by Article 3 of Law No. 8373 of August 18, 2004).

</span></p><p style="margin-top:0pt; margin-left:28.35pt; margin-bottom:0pt; text-align:justify"><span style="font-family:'Times New Roman'; font-style:italic">d) Develop, recommend, coordinate, execute, and disseminate the regulations and provisions that guarantee the application of this law.</span></p><p style="margin-top:0pt; margin-left:28.35pt; margin-bottom:0pt; text-align:justify"><span style="font-family:'Times New Roman'; font-style:italic">e) Order and execute the technical, legal, and administrative measures to avoid, prevent, and delay the introduction or establishment of new pests in plants.</span></p><p style="margin-top:0pt; margin-left:28.35pt; margin-bottom:0pt; text-align:justify"><span style="font-family:'Times New Roman'; font-style:italic">f) Eradicate, control, or retard the spread of pests already introduced.</span></p><p style="margin-top:0pt; margin-left:28.35pt; margin-bottom:0pt; text-align:justify"><span style="font-family:'Times New Roman'; font-style:italic">g) Carry out phytosanitary control of the national and international exchange of plants, biological control agents and other types of organisms used in agriculture, packaging and conditioning materials, and means of transport capable of spreading or introducing pests that threaten food security and the economic activity on which agricultural production is based.</span></p><p style="margin-top:0pt; margin-left:28.35pt; margin-bottom:0pt; text-align:justify"><span style="font-family:'Times New Roman'; font-style:italic">h) Formulate, execute, and supervise pest survey and detection programs, as well as emergency plans.</span></p><p style="margin-top:0pt; margin-left:28.35pt; margin-bottom:0pt; text-align:justify"><span style="font-family:'Times New Roman'; font-style:italic">i) Study and diagnose the phytosanitary status of the country.</span></p><p style="margin-top:0pt; margin-left:28.35pt; margin-bottom:0pt; text-align:justify"><span style="font-family:'Times New Roman'; font-style:italic">j) Establish and keep updated a national information system regarding the phytosanitary status.</span></p><p style="margin-top:0pt; margin-left:28.35pt; margin-bottom:0pt; text-align:justify"><span style="font-family:'Times New Roman'; font-style:italic">k) Officially declare the presence of pests and their quarantine importance.</span></p><p style="margin-top:0pt; margin-left:28.35pt; margin-bottom:0pt; text-align:justify"><span style="font-family:'Times New Roman'; font-style:italic">l) Evaluate and regulate, in the area of plant protection, any production method.</span></p><p style="margin-top:0pt; margin-left:28.35pt; margin-bottom:0pt; text-align:justify"><span style="font-family:'Times New Roman'; font-style:italic">m) Organize, endorse or not endorse, and support the development, dissemination, and application of programs for the prevention and combat of existing pests.</span></p><p style="margin-top:0pt; margin-left:28.35pt; margin-bottom:0pt; text-align:justify"><span style="font-family:'Times New Roman'; font-style:italic">n) Promote and control integrated pest management and the appropriate methodologies used.</span></p><p style="margin-top:0pt; margin-left:28.35pt; margin-bottom:0pt; text-align:justify"><span style="font-family:'Times New Roman'; font-style:italic">ñ) Control the phytosanitary quality of propagation material.</span></p><p style="margin-top:0pt; margin-left:28.35pt; margin-bottom:0pt; text-align:justify"><span style="font-family:'Times New Roman'; font-style:italic">o) </span><span style="font-family:'Times New Roman'; font-weight:bold; font-style:italic; text-decoration:underline">Control chemical, biological, or related substances for agricultural use, regarding their registration, import, export, quality, tolerance, residues, dosages, effectiveness, toxicity, presentation to the public, conservation, handling, trade, general conditions of use, safety and precautions in transport, storage, disposal of containers and residues of such substances; likewise, control the equipment necessary to apply them and any other activity inherent to this matter</span><span style="font-family:'Times New Roman'; font-style:italic">.</span></p><p style="margin-top:0pt; margin-left:28.35pt; margin-bottom:0pt; text-align:justify"><span style="font-family:'Times New Roman'; font-style:italic">p) Control the phytosanitary quality of plants for export to issue phytosanitary certificates, in accordance with the international treaties in force on the matter, this law, and its regulations.</span></p><p style="margin-top:0pt; margin-left:28.35pt; margin-bottom:0pt; text-align:justify"><span style="font-family:'Times New Roman'; font-style:italic">q) Regulate, in the area of plant protection, the import, export, research, experimentation, movement, multiplication, industrial production, commercialization, and use of transgenic materials and other genetically modified organisms for agricultural use or their products.</span></p><p style="margin-top:0pt; margin-left:28.35pt; margin-bottom:0pt; text-align:justify"><span style="font-family:'Times New Roman'; font-style:italic">r) Promote, support, and endorse the required phytosanitary scientific research.</span></p><p style="margin-top:0pt; margin-left:28.35pt; margin-bottom:0pt; text-align:justify"><span style="font-family:'Times New Roman'; font-style:italic">s) Manage technical and financial support from national and international organizations to strengthen the State Phytosanitary Service (Servicio Fitosanitario del Estado).</span></p><p style="margin-top:0pt; margin-left:28.35pt; margin-bottom:0pt; text-align:justify"><span style="font-family:'Times New Roman'; font-style:italic">t) Recommend to the Executive Branch the ad honorem appointment of phytosanitary authorities.</span></p><p style="margin-top:0pt; margin-left:28.35pt; margin-bottom:0pt; text-align:justify"><span style="font-family:'Times New Roman'; font-style:italic">u) Ensure the administration, control, and use of the resources obtained by applying this law.</span></p><p style="margin-top:0pt; margin-left:28.35pt; margin-bottom:0pt; text-align:justify"><span style="font-family:'Times New Roman'; font-style:italic">v) Provide, by prior agreement, training, advice, and consulting on phytosanitary protection matters.</span></p><p style="margin-top:0pt; margin-left:28.35pt; margin-bottom:0pt; text-align:justify"><span style="font-family:'Times New Roman'; font-style:italic">x) Promote the international harmonization of phytosanitary measures.</span></p><p style="margin-top:0pt; margin-left:28.35pt; margin-bottom:0pt; text-align:justify"><span style="font-family:'Times New Roman'; font-style:italic">The controls mentioned in this article may be carried out fully or randomly, as established through technical criteria."</span><span style="font-family:'Times New Roman'"> (The highlighted text does not correspond to the original).</span></p><p style="margin-top:0pt; margin-bottom:0pt"><span style="font-family:'Times New Roman'; -aw-import:ignore">&nbsp;</span></p><p style="margin-top:0pt; margin-bottom:0pt; text-align:justify; line-height:150%; font-size:14pt"><span style="font-family:'Times New Roman'">From the foregoing, it follows that the authority to "control chemical, biological, or related substances for agricultural use, regarding their registration" was expressly assigned by the legislator to the SFE, without prejudice—as provided in the same article—to coordinating, with other ministries and their dependencies, the pertinent actions for the fulfillment of this law and its regulations. </span></p><p style="margin-top:0pt; margin-bottom:0pt; text-align:justify; line-height:150%; font-size:14pt"><span style="font-family:'Times New Roman'">Furthermore, the law expressly establishes that the substances must be registered in the registry that the SFE is precisely responsible for creating and maintaining, and it also sets forth the consequences for not following the procedure: </span></p><p style="margin-top:0pt; margin-left:28.35pt; margin-bottom:0pt; text-align:justify"><span style="font-family:'Times New Roman'; font-weight:bold; font-style:italic">"Art. 23. Registration of substances and equipment.</span></p><p style="margin-top:0pt; margin-left:28.35pt; margin-bottom:0pt; text-align:justify"><span style="font-family:'Times New Roman'; font-style:italic">According to the requirements to be specified in the regulation of this law, all chemical, biological, or related substances and application equipment for agricultural use must be registered in the registry that the State Phytosanitary Service will create to have information on their characteristics and ensure their correct use in the country.</span></p><p style="margin-top:0pt; margin-left:28.35pt; margin-bottom:0pt; text-align:justify"><br><span style="font-family:'Times New Roman'; font-weight:bold; font-style:italic">Art. 24.- Registry of substances</span></p><p style="margin-top:0pt; margin-left:28.35pt; margin-bottom:0pt; text-align:justify"><span style="font-family:'Times New Roman'; font-style:italic">No natural or legal person may import, export, manufacture, formulate, store, distribute, transport, repack, refill, advertise, handle, mix, sell, or use chemical, biological, or related substances for agricultural use that are not registered in accordance with this law. (…)"</span></p><p style="margin-top:0pt; margin-bottom:0pt"><span style="font-family:'Times New Roman'; -aw-import:ignore">&nbsp;</span></p><p style="margin-top:0pt; margin-bottom:0pt; text-align:justify; line-height:150%; font-size:14pt"><span style="font-family:'Times New Roman'">It is required, of course, that these powers must be exercised within the framework of the constitutional rights to health and a healthy environment, and that the SFE authorities must in all cases safeguard such rights. </span></p><p style="margin-top:0pt; margin-bottom:0pt; text-align:justify; line-height:150%; font-size:14pt"><span style="font-family:'Times New Roman'">In this regard, it is necessary to emphasize that this Court, in judgment </span><span style="font-family:'Times New Roman'; font-weight:bold">No. 2022-023238</span><span style="font-family:'Times New Roman'">, already established that, although the registries are under the authority of the SFE, the other indicated ministries have the possibility of warning, within their area of competence, of the existence of prohibited materials or those subject to new restrictions in accordance with international regulations falling under such competencies. It was noted that this type of regulation does not imply that the other functions of the two ministries are diminished and that they cannot exercise active participation and collaboration, prior to the granting of registration or in the oversight function, when a registration fails to comply with international obligations due to the use of internationally prohibited products; for example, international standards of unacceptable risks to health and the environment (see judgment </span><span style="font-family:'Times New Roman'; font-weight:bold">No. 2022-023238</span><span style="font-family:'Times New Roman'">). Indeed, in the report rendered in case file No. 18-009107-0007-CO, the PGR stated the following:</span></p><p style="margin-top:0pt; margin-left:28.35pt; margin-bottom:0pt; text-align:justify"><span style="font-family:'Times New Roman'; font-style:italic">"[T]he possible flexibilization of the pesticide registration procedure made by decree No. 40059-MAG-MINAE-S in an effort to provide the agricultural sector with greater access to lower-cost products or inputs, </span><span style="font-family:'Times New Roman'; font-weight:bold; font-style:italic; text-decoration:underline">cannot be to the detriment of the legal authority of the technical bodies of MAG, MINAE, and MINSA to require the information they deem pertinent and determine, through rigorous evaluations and data analysis, that the requested agrochemicals are harmless to people's health and the environment</span><span style="font-family:'Times New Roman'; font-style:italic">".</span><span style="font-family:'Times New Roman'"> (The highlighted text does not correspond to the original). </span></p><p style="margin-top:0pt; margin-bottom:0pt; text-align:justify; line-height:150%"><span style="font-family:'Times New Roman'; -aw-import:ignore">&nbsp;</span></p><p style="margin-top:0pt; margin-bottom:0pt; text-align:justify; line-height:150%; font-size:14pt"><span style="font-family:'Times New Roman'">Moreover, it should be noted that the criticisms made by the claimant—in light of the CGR's considerations—had a different regulatory context, because precisely in response to such recommendations and omissions, a transitional measure was expressly adopted in Executive Decree No. 40059 "Technical Regulation: 'RTCR 484:2016. Agricultural Inputs. Formulated Synthetic Pesticides, Technical Grade Active Ingredient, Adjuvants, and Related Substances for Agricultural Use. Registration, Use, and Control'", effective as of July 13, 2017, which precisely aims to provide the MAG and the SFE with suitable technical bodies to resolve everything related to the registrations of agrochemicals and expressly establishes that said body must operate "without prejudice to the constitutional or legal powers corresponding to the Ministries of Health or Environment": </span></p><p style="margin-top:0pt; margin-left:28.35pt; margin-bottom:0pt; text-align:justify"><span style="font-family:'Times New Roman'; font-style:italic">"</span><span style="font-family:'Times New Roman'; font-weight:bold; font-style:italic">FIFTH TRANSITORY PROVISION:</span><span style="font-family:'Times New Roman'; font-weight:bold; font-style:italic">&nbsp;</span><span style="font-family:'Times New Roman'; font-style:italic">The Ministry of Agriculture and Livestock shall establish within its structure, within a period of twelve months from the effective date of this decree,</span><span style="font-family:'Times New Roman'; font-style:italic">&nbsp;</span><span style="font-family:'Times New Roman'; font-style:italic">the </span><span style="font-family:'Times New Roman'; font-weight:bold; font-style:italic; text-decoration:underline">Evaluation Areas: chemical, agronomic, toxicological, and the</span><span style="font-family:'Times New Roman'; font-weight:bold; font-style:italic; text-decoration:underline">&nbsp;</span><span style="font-family:'Times New Roman'; font-weight:bold; font-style:italic; text-decoration:underline">ecotoxicological</span><span style="font-family:'Times New Roman'; font-weight:bold; font-style:italic; text-decoration:underline">, as</span><span style="font-family:'Times New Roman'; font-weight:bold; font-style:italic; text-decoration:underline">&nbsp;</span><span style="font-family:'Times New Roman'; font-weight:bold; font-style:italic; text-decoration:underline">part of</span><span style="font-family:'Times New Roman'; font-weight:bold; font-style:italic; text-decoration:underline">&nbsp;</span><span style="font-family:'Times New Roman'; font-weight:bold; font-style:italic; text-decoration:underline">the Agrochemical and Application Equipment Registration Unit, and which shall be in</span><span style="font-family:'Times New Roman'; font-weight:bold; font-style:italic; text-decoration:underline">&nbsp;</span><span style="font-family:'Times New Roman'; font-weight:bold; font-style:italic; text-decoration:underline">charge of the</span><span style="font-family:'Times New Roman'; font-weight:bold; font-style:italic; text-decoration:underline">&nbsp;</span><span style="font-family:'Times New Roman'; font-weight:bold; font-style:italic; text-decoration:underline">review, verification of compliance with requirements, evaluation, and qualification of</span><span style="font-family:'Times New Roman'; font-weight:bold; font-style:italic; text-decoration:underline">&nbsp;</span><span style="font-family:'Times New Roman'; font-weight:bold; font-style:italic; text-decoration:underline">the documents</span><span style="font-family:'Times New Roman'; font-weight:bold; font-style:italic; text-decoration:underline">&nbsp;</span><span style="font-family:'Times New Roman'; font-weight:bold; font-style:italic; text-decoration:underline">and toxicological and</span><span style="font-family:'Times New Roman'; font-weight:bold; font-style:italic; text-decoration:underline">&nbsp;</span><span style="font-family:'Times New Roman'; font-weight:bold; font-style:italic; text-decoration:underline">ecotoxicological</span><span style="font-family:'Times New Roman'; font-weight:bold; font-style:italic; text-decoration:underline">&nbsp;</span><span style="font-family:'Times New Roman'; font-weight:bold; font-style:italic; text-decoration:underline">and environmental fate studies established by this regulation in the different registration modalities, without prejudice to the constitutional or legal powers corresponding to the Ministries of Health or Environment</span><span style="font-family:'Times New Roman'; font-style:italic">".</span><span style="font-family:'Times New Roman'"> (The highlighted text does not correspond to the original). </span></p><p style="margin-top:0pt; margin-bottom:0pt; text-align:justify; line-height:150%"><span style="font-family:'Times New Roman'; -aw-import:ignore">&nbsp;</span></p><p style="margin-top:0pt; margin-bottom:0pt; text-align:justify; line-height:150%; font-size:14pt"><span style="font-family:'Times New Roman'">Consequently, it is the responsibility of the national technical authorities, in accordance with the broad powers granted by the legal system, to carry out the procedure for updating the information in the registration dossiers for technical grade active ingredient and formulated pesticides with utmost rigor and care in order to safeguard the fundamental rights to health and a healthy environment of all inhabitants. Thus, the ultimate responsibility for the decision on whether or not to authorize the request to update the products lies with the national authorities. In this sense, judgment No. 2022-023238 concluded that in each specific petition—in this specific case, it refers to the updating of information in the registration dossiers for technical grade active ingredient and formulated pesticides—, it is the responsibility of our national authorities to be vigilant regarding the studies submitted to them for assessment, and this does not imply, in any way, an authorization for them to relax in the processing and oversight that must be carried out. </span></p><p style="margin-top:0pt; margin-bottom:0pt; text-align:justify; line-height:150%; font-size:14pt"><span style="font-family:'Times New Roman'">On this point, it should be added that, even if we had the highest normative standards, this alone would not be sufficient if the national authorities do not responsibly exercise the powers that concern them. In this sense, a dismissal of the grievance does not mean that it is being endorsed that the authorities are not vigilant </span><span style="font-family:'Times New Roman'; font-style:italic">a priori</span><span style="font-family:'Times New Roman'"> and </span><span style="font-family:'Times New Roman'; font-style:italic">a posteriori</span><span style="font-family:'Times New Roman'">. On the contrary, this Chamber understands that, even at the slightest hint of doubt, they must proceed to require all relevant documentation or studies, with the purpose of verifying that the product for which the registration is to be updated meets the parameters and conditions necessary to protect human health. Likewise, it is their responsibility to ensure that its use is appropriate and has the desired effects. Rigor in the selection of studies is as important as the subsequent controls that can be carried out in the application and use of the products. </span></p><p style="margin-top:0pt; margin-bottom:0pt; text-align:justify; line-height:150%; font-size:14pt"><span style="font-family:'Times New Roman'">It is appropriate to cite the reflections made by this Chamber in judgment </span><span style="font-family:'Times New Roman'; font-weight:bold">No. 2011-016937</span><span style="font-family:'Times New Roman'">, regarding its knowledge of other regulations aimed at the registration of pesticides:</span></p><p style="margin-top:0pt; margin-left:28.35pt; margin-bottom:0pt; text-align:justify"><span style="font-family:'Times New Roman'; font-style:italic">"</span><span style="font-family:'Times New Roman'; font-weight:bold; font-style:italic">VII.- ON THE REDUCTION OF RISKS TO HEALTH AND THE ENVIRONMENT, PURSUANT TO THE PROVISIONS OF ARTICLE 5 OF THE INTERNATIONAL CODE OF CONDUCT ON THE DISTRIBUTION AND USE OF PESTICIDES.</span><span style="font-family:'Times New Roman'; font-style:italic"> It is of interest to refer to the provisions of the cited International Code of Conduct on the Distribution and Use of Pesticides, which was adopted for the first time in 1985 by the Twenty-fifth Session of the Conference of the Food and Agriculture Organization of the United Nations (FAO). As explained in the preface of the revised version (adopted by the 123rd Session of the FAO Council, November 2002), this code of conduct was adopted and has been revised with the purpose of achieving greater food security and, at the same time, protecting human health and the environment. For these purposes, standards of conduct are established that are to serve as a framework and point of reference for the proper and rational use of pesticides, focusing on risk reduction, the protection of human and environmental health, and support for the development of sustainable agriculture through the effective use of pesticides [source: (Source: http://www.fao.org/agriculture/crops/core-themes/theme/pests/pm/code/en/(05/08/11)] (…)</span></p><p style="margin-top:0pt; margin-left:28.35pt; margin-bottom:0pt; text-align:justify"><span style="font-family:'Times New Roman'; font-weight:bold; font-style:italic; -aw-import:ignore">&nbsp;</span></p><p style="margin-top:0pt; margin-left:28.35pt; margin-bottom:0pt; text-align:justify"><span style="font-family:'Times New Roman'; font-weight:bold; font-style:italic">VIII.- ON THE REGULATION OF PESTICIDE REGISTRATION.</span><span style="font-family:'Times New Roman'; font-style:italic"> The proper use of pesticides can be useful for the control and elimination of pests, to the benefit of the food security of the population and the economic activity based on agricultural production. However, the potential risk that the use of such substances may pose to human health and the environment must be recognized. This has even led to the adoption of international instruments with the express objective of protecting human health—including the health of consumers and workers—and the environment from the possible harmful effects of pesticides, as is the case of the Rotterdam Convention on the Prior Informed Consent Procedure for Certain Hazardous Chemicals and Pesticides in International Trade, which was approved by Costa Rica through Law No. 8705 of February 13, 2009. In that case, given the mandatory legislative consultation on constitutionality raised before this Tribunal (case file number 08-015252-0007-CO), prior to the approval of said international instrument, this Tribunal indicated—in what is relevant—that:</span></p><p style="margin-top:0pt; margin-left:28.35pt; margin-bottom:0pt; text-align:justify"><span style="font-family:'Times New Roman'; font-style:italic; -aw-import:ignore">&nbsp;</span></p><p style="margin-top:0pt; margin-left:56.7pt; margin-bottom:0pt; text-align:justify"><span style="font-family:'Times New Roman'; font-style:italic">"(…) </span><span style="font-family:'Times New Roman'; font-weight:bold; font-style:italic; text-decoration:underline">the Costa Rican State has the duty to act effectively and proactively to prevent the occurrence of events that degrade the environment and compromise its sustainability</span><span style="font-family:'Times New Roman'; font-style:italic">. From that perspective, its commitment, through an international treaty such as the one consulted, or through an internal act, to facilitate the rational use of chemically hazardous products subject to international trade is not only possible, but entirely consistent with its constitutional duties. Pesticides and industrial chemical products are substances that can cause harm to human health and the environment. Faced with such a threat, the Rotterdam Convention provides the Parties with the possibility of knowing in advance the composition and effects of certain chemical products, which are expressly indicated in its Annex III. The suitable measures that the State takes to regulate the commercialization and use of said products in industrial, agricultural, etc. activities are consistent with its duty to preserve the aforementioned values of constitutional rank. Hence, the duties that the State would assume if it definitively approved this Convention are legitimate, in accordance with Constitutional Law. This would be a sovereign decision by the State to submit to the obligations contained in the Convention, to contribute to the protection of people's health and the integrity of the environment, from which it can be concluded that, in general terms, no defects of unconstitutionality are observed in the clauses of the Rotterdam Convention, the approval of which is submitted for consultation." (resolution number 2008-018207 of 6:15 p.m. on December 10, 2008)</span></p><p style="margin-top:0pt; margin-left:28.35pt; margin-bottom:0pt; text-align:justify"><span style="font-family:'Times New Roman'; font-style:italic; -aw-import:ignore">&nbsp;</span></p><p style="margin-top:0pt; margin-left:28.35pt; margin-bottom:0pt; text-align:justify"><span style="font-family:'Times New Roman'; font-style:italic">Thus, it is verified that this Tribunal has recognized the risk that the use of pesticides may entail and the importance of adopting suitable measures to regulate their use. </span><span style="font-family:'Times New Roman'; font-weight:bold; font-style:italic; text-decoration:underline">In the Costa Rican legal system, there is diverse legal and regulatory legislation from which it follows that the activity of import, manufacture, commercialization, and use of pesticides is strongly subject to the police power of the State, in order to guarantee the right to health and a healthy and ecologically balanced environment</span><span style="font-family:'Times New Roman'; font-style:italic">. </span></p> We may cite, in the first place, the General Health Law (Ley General de Salud), which in its Article 213 provides:

“ARTICLE 213.- Every person, natural or juridical, who engages in producing food, must do so under sanitary environmental conditions and employing defense or conservation techniques approved by the health authority, in order to avoid, principally, the contamination of such products and their dangerousness due to the presence of toxic residues coming from their treatment with pesticides (plaguicidas) or other defense or conservation systems.” Meanwhile, Article 244 of that same normative body establishes:

“ARTICLE 244.- Natural and juridical persons who import, manufacture, handle, store, transport, trade, supply, or apply substances, mixtures of substances, or products denominated pesticides (plaguicidas) by the plant health law, shall be subject to the regulatory provisions that the Ministry dictates in common agreement with the Ministry of Agriculture for the safeguarding of the health of persons in conformity with that law; interested parties must register every pesticide or product destined for the control or extermination of infestations and request prior permission to operate when such substances, mixtures of substances, or products that, by their nature or use, are not included in the mentioned law, are capable in any way of producing poisonings or serious harm to the health of persons or of animals that are useful or harmless to man.” For its part, through the Plant Protection Law (Ley de Protección Fitosanitaria) (Law No. 7664 of April 8, 1997), the plant protection measures established in that law and its regulations were declared of public interest and mandatory application (art. 1). Furthermore, within the objectives of said law is included: “To regulate the use and handling of chemical, biological, or related substances (sustancias químicas, biológicas o afines) and equipment for applying them in agriculture; likewise, their registration, importation, quality, and residues, while seeking to protect human health and the environment” (article 2, subsection e). The competent authority in the matter is the State Phytosanitary Service (Servicio Fitosanitario del Estado), to which it corresponds—among other functions—to: “Control chemical, biological, or related substances for agricultural use, regarding their registration, importation, exportation, quality, tolerance, residues, dosages, effectiveness, toxicity, presentation to the public, conservation, handling, trade, general conditions of use, safety, and precautions in transport, storage, elimination of containers, and residues of such substances; likewise, control the equipment necessary to apply them and any other activity inherent to this matter” (article 5, subsection o).

(…)

It follows from the previously cited regulations that, as a manifestation of the referred police power, the necessary registration of pesticides (plaguicidas) is included prior to authorizing their importation, manufacture, commercialization, or use, in order to exercise prior control regarding the due compliance with the corresponding technical requirements of quality and safety, in protection of public health and the environment.

Said considerations are applicable in the sub lite, that is, that the domestic legal system contemplates varied regulations and competencies in favor of the national technical authorities so that, in use of that police power, they remain vigilant and guarantee the quality and benefit of the pesticide (plaguicidas) products whose registrations are intended to be updated and, ultimately, that the rights of all persons are thus safeguarded.

In this regard, as will be seen infra in detail, the challenged regulations are not designed for the registration of new pesticide (plaguicidas) products, but to update the registrations of products that are already registered and are freely commercialized in the national market. At the slightest doubt that the duly registered pesticide (plaguicida) (whether as technical grade active ingredient (ingrediente activo grado técnico, IAGT) or formulated pesticide (plaguicida formulado)) causes harm or a threat to health or the environment, all national authorities, including the Ministry of Health or MINAE, have their own attributions and competencies to institute the corresponding procedures to prevent the importation, manufacture, handling, commercialization, or use of the product. Moreover, if necessary, they can dictate the precautionary measures needed to safeguard the legal interests mentioned. Precisely, the precautionary principle (principio precautorio) —which is invoked by the claimant— must inspire all the a priori and a posteriori control conduct of all the public authorities in question, and if in any specific case there is suspicion or evidence of harm or threats to public health or the environment, they are under the constitutional obligation to adopt the corresponding preventive measures.

We must echo what was already indicated in judgment No. 2017-06668, regarding the constitutionality of executive decree (decreto ejecutivo) No. 39995-MAG, and which is also applicable to this decree, since the fact that the Ministers of Health and Environment and Energy did not sign the decree does not constitute a defect of unconstitutionality of the questioned regulations because it was issued, jointly, by the President of the Republic and the Minister of Agriculture, whereby, no affectation of the provisions of art. 146 of the Political Constitution is appreciated.

Finally, it is reiterated that, in light of the provisions of art. 10 of the General Law of Public Administration (Ley General de la Administración Pública, LGAP) —the administrative rule must be interpreted in the manner that best guarantees the realization of the public purpose to which it is directed—, this special regulation must be applied and interpreted integrally with the provisions of the legal system on the matter (public interest laws mentioned supra). That is, it can in no way be understood that the challenged provisions constitute a normative body isolated from the rest of the block of legality and constitutionality, and that the specific task of updating the information of the registrations implies annulling the rest of the legal competencies entrusted to other ministerial portfolios.

By virtue of the foregoing, based on the considerations made, this Chamber cannot accredit the supposed injuries to the precautionary principle (principio precautorio) attributed to the decree, solely by the fact that it is signed by the MAG and because the competencies for updating the registration are concentrated in the SFE. As examined, such competencies are powers of authority (potestades de imperio) granted by the legislator itself (art. 59 LGAP) which does not render without effect the other legal provisions of public interest in the matter.

**VII.- ON THE PROCEDURE GOVERNED BY THE CHALLENGED REGULATIONS** The **claimant** insists that the Ministry of Health and MINAE must intervene in these processes even more so in this case, which is not a simple update, but rather a scientific analysis of the information presented by the registrant to carry out the respective risk evaluation.

On this point, the **Minister of Agriculture and Livestock** explains that the decree for updating dossiers (expedientes) and its reform applies exclusively to all registrations of “technical grade active ingredient (ingrediente activo grado técnico, IAGT)” (IAGT) and formulated products that were registered under a different regulation (legal or regulatory) than executive decree (decreto ejecutivo) No. 33495-MAG-S-MEIC-MINAET, “Regulation on Registration, Use and Control of Synthetic Formulated Pesticides (Plaguicidas Sintéticos Formulados), Technical Grade Active Ingredient (Ingrediente Activo Grado Técnico), Adjuvants (Coadyuvantes) and Related Substances (Sustancias Afines) of Agricultural Use”. That is, he emphasizes that it only applies to those product registration dossiers (expedientes) for products already on the market that were registered in accordance with the regulations applicable at the time of their approval and were evaluated comprehensively (health, environment, and biological efficacy) in accordance with those regulations. He argues that the claimant confuses and intends to confuse regarding agrochemicals registered and currently marketed in the country, which are those to which executive decree (decreto ejecutivo) No. 39995-MAG and No. 41481-MAG apply, attempting to make it seem that they must be evaluated again, which is neither appropriate nor necessary, since all products registered in Costa Rica complied with the requirements and regulations established in the positive law in force at the time those registrations were granted. Consequently, he vehemently clarifies that for none of the pesticide (plaguicidas) products, whether raw materials or formulated products with a current registration, is there scientific technical evidence or presumption, or at least indications, that presume an additional or resulting danger from its application, regarding human health, the environment, or the biological efficacy of the pesticide (plaguicida). Both the Constitutional Chamber and the PGR have been clear in the sense that the Ministry of Health, the Ministry of Environment, the Ministry of Agriculture, or even private individuals may appeal to the ordinary jurisdictional venue to request the annulment of the administrative acts through which those registrations were granted, and may even request that their commercialization be precautionarily suspended. However, neither the Ministry of Health, nor the Ministry of Environment, nor the claimant do so because they lack proof, scientific and technical support to do so, and, therefore, he understands that the claimant recklessly comes to the Constitutional Chamber to raise legality issues through unconstitutionality actions, whose sole purpose and objective is to hinder the process of organizing the agrochemical registration system undertaken by the Administration.

He insists that with the mentioned decrees —No. 39995-MAG and No. 41481-MAG— registrations of IAGT or new formulated pesticides (plaguicidas formulados) are not being granted, but rather they only apply to old IAGT (raw materials) and formulated products. In this regard, he explains that it was as of 2007 that a registration system was established that requires prior registration of the raw material —IAGT—. Before that date, it was not necessary to register the IAGT, and that is why the Executive Branch issued the decrees under challenge. He contends that it is not as the claimant indicates, that through the challenged rules the registration of new products is being facilitated, since the truth is that nothing is being facilitated; rather, a space is opened for the registration holders to submit the confidential chemical information, which is fundamental to guarantee that there are no relevant impurities from a toxicological and ecotoxicological point of view in any of the products currently marketed by virtue of a current registration, granted for an indefinite term. Therefore, he maintains that it is not correct to state that with the application of these rules, the registrations whose dossiers (expedientes) are updated pose an additional risk to health, the environment, or agriculture, since all IAGT registrations granted must necessarily and unavoidably correspond to one of the formulations already sold on the market, and over these formulations the Ministries of Health or Environment have ample and indisputable competencies and powers to adopt the pertinent measures in order to prevent harm to health or the environment.

He points out that executive decree (decreto ejecutivo) No. 39995-MAG and its reform No. 41481-MAG allow resolving the problems of disorder, uncertainty, and lack of information in the registration dossiers (expedientes) that support the registrations of IAGTs and formulated pesticides (plaguicidas formulados) with a current registration, but that were granted under a regulation different from executive decree (decreto ejecutivo) No. 33495-MAG-S-MINAE-MEIC. He considers that the questioned regulations are a great advance and solve a problem that began in 2004 and had not yet been resolved by previous administrations, as it provides for alternatives and pathways to resolve the two most serious problems afflicting our country's registration system: on the one hand, the paralysis in registering new and generic products, and on the other, the impossibility of renewing registrations for formulations currently on the market.

In that sense, he details that the challenged regulations allow: a) the updating of manufacturers, their origin, production sites of the IAGTs associated with formulations already marketed in Costa Rica and that were registered under different legislation; b) the same in relation to formulated pesticides (plaguicidas formulados); c) ending the legal uncertainty regarding the validity of IAGT registrations and formulated pesticides (plaguicidas formulados) that were registered under previous legislation and regulations, standardizing the term of validity to ten years for all registrations and thus eliminating indefinite validity. He explains, consequently, that all the chemical information required to be able to make decisions regarding the product in terms of its safety and efficacy is added to the registration dossier (expediente) required in art. 23 of the Plant Protection Law (Ley de Protección Fitosanitaria), and putting a stop to indefinite-term registrations.

In processing the amparo appeal **No. 17-002503-0007-CO**, the then Minister of MAG informed under the gravity of oath before this Chamber the following:

“regarding the foundation giving rise to the promulgation of Executive Decree (Decreto Ejecutivo), No. 39995-MAG, we find it in the 7 considering clauses (considerandos), of which the first 6 provide the legal foundation, in this case the Plant Protection Law (Ley de Protección Fitosanitaría) No. 7664 whose object is to regulate the use and handling of chemical, biological, or related substances (sustancias químicas, biológicas o afines) and equipment to apply them in agriculture; likewise, their registration, importation, quality, and residues, while seeking at the same time to protect human health and the environment, all of which must be inscribed in the registry that the State Phytosanitary Service (Servicio Fitosanitario del Estado) will create to have information on the characteristics of these and ensure their correct use in the country. Pesticides (Plaguicidas) for agricultural use are fundamental for combating pests that affect agricultural production and for the competitiveness of agricultural producers; therefore, it is essential to guarantee the supply and continuity in the commercialization of products that currently have a current registration, making it necessary to update the information in their dossiers (expedientes) on the characteristics of these and ensure their correct use in the country. It is precisely this considering clause (considerando) that summarizes the object of the decree under analysis. The decree indicates in its considering clause 4 that regulations prior to the effectiveness of executive decree (decreto ejecutivo) No. 33495 MAG-S-MENAE-ME1C of October 31, 2006, and its reforms, allowed the Ministry of Agriculture and Livestock to grant indefinite-term registrations as well as the registration of formulated pesticides (plaguicidas formulados) without it being a requirement to have prior registration of the technical grade active ingredient (ingrediente activo grado técnico, IAGT) (IAGT), which obliges, within the constitutional and legal powers of the Executive Branch, to organize its registry, ordering the updating of the information of registrations inscribed without a term, having been granted under a regulation prior to the one governing the current registration. The challenged decree seeks to update the dossiers (expedientes) with the information that was not requested at the time of their registration and to have updated information, through a re-registration process in accordance with Constitutional Article 50, such that the State shall seek the greatest well-being for all the inhabitants of the country, organizing and stimulating production and the most adequate distribution of wealth, guaranteeing a healthy and ecologically balanced environment. The State shall guarantee, defend, and preserve that right, which is guaranteed by the decree since, although production is stimulated, that does not prevent protecting the environment and health and life, none of which can be put at risk, which is why the Ministry of Agriculture and Livestock has the legal power to administer the registry assigned to it by law and for which, at a minimum, it must update the dossiers (expedientes) as part of its internal organization. Registrations granted prior to Executive Decree (Decreto Ejecutivo) No. 33495-MAGS- MINAE-MEIC of October 31, 2006, and its reforms, were granted without a term, which obliges the Executive to an analysis of those registrations, requesting from each registrant the information established in the Decree at hand to update the registration and therefore the information, in such a way that registrants can register in accordance with the requirements of current regulations, guaranteeing at the same time the continuity of their commercialization, given their importance as a tool for combating agricultural pests and also stimulating the production entrusted by law to the Ministry of Agriculture and Livestock, without detriment to other constitutional guarantees such as life and a healthy environment, this provided that production is not harmed, so long as life is not affected. Due to the nature of the regulation issued, this is not a technical regulation (Reglamento técnico) but rather an update of current registrations, so the technical regulation procedure is not required; however, the regulation was posted on the MEIC website, as evidenced in the attached administrative dossier (expediente administrativo), completing the Cost-Benefit Evaluation Form in Section 1, denominated Prior Control of Regulatory Improvement, which yielded a negative result and was available to citizens as it is a freely accessible website. The decree, in summary, provides that holders of registrations of Technical Grade Active Ingredients (Ingredientes Activos Grado Técnico, IAGT) (IAGT) and of formulated products that do not have an IAGT registration, and that were not inscribed in accordance with Executive Decree (Decreto Ejecutivo) No. 33495-MAG-S- MINAE-MEIC of October 31, 2006, and its reforms, must update the manufacturer(s) of their IAGTs, within a period of twenty-four months from the entry into force of this decree; providing to the State Phytosanitary Service (Servicio Fitosanitario del Estado) the information indicated therein for manufacturer updating, also referring to the provisions of the Central American Technical Regulation (Reglamento Técnico Centroamericano) No. RTCA 65.05.67.13: Agricultural Inputs. Technical Grade Active Ingredient (Ingrediente Activo Grado Técnico), Chemical Formulated Pesticides (Plaguicidas Químicos Formulados), Related Substances, Adjuvants (Coadyuvantes) and Physical Carriers of Agricultural Use. Requirements for the Preparation of Labels and Leaflets. Resolution No. 365-2015 (COMIECO LXXII). In the case of formulated pesticides (plaguicidas formulados) whose IAGT is not registered, and whose dossier (expediente) has been updated, the State Phytosanitary Service (Servicio Fitosanitario del Estado) shall grant, within a period of no more than three months, counted from the date on which the update was approved, the corresponding IAGT registration. The decree expressly establishes that the IAGT registrations granted, in accordance with the decree, may not be used as a reference profile under the registration by equivalence modality, unless the complete data package has been provided. Article 7 refers to the legal powers that different laws grant to the Ministry of Health and the Ministry of Environment, but not to the administration of the registry, which is what the regulation intends, since the power of the Ministries of Health, Environment, and Agriculture to restrict or prohibit a use of a pesticide (plaguicida) is independent of the reference decree. Based on the report rendered and the administrative dossier (expediente administrativo), as well as the text of the challenged decree, it appears that the Decree pursues the internal organization of the SFE Registry Office, as an organ of minimal deconcentration (desconcentración mínima) of the Ministry of Agriculture and Livestock. I request that this amparo appeal be declared without merit in all its aspects.” In this regard, **the Chamber** considers it necessary to clarify the scope of the regulations challenged in action No. 18-019039-0007-CO (relating to executive decree (decreto ejecutivo) No. 39995-MAG) and those known in this action (relating to executive decree (decreto ejecutivo) No. 41481-MAG).

For the above, it is appropriate to cite the recital part or preamble of both decrees, as they offer important light on the objectives of the rules in question.

The "Regulation for updating the information in the registration dossiers of technical-grade active ingredient and formulated pesticides, No. 39995-MAG," is based on the following premises:

"1°-That one of the objectives of the Phytosanitary Protection Law (Ley de Protección Fitosanitaria) is to regulate the use and management of chemical, biological, or related substances and equipment for applying them in agriculture; likewise, their registration, importation, quality, and residues, while seeking to protect human health and the environment.

2°-That the Phytosanitary Protection Law (Ley de Protección Fitosanitaria) expressly establishes that all chemical, biological, or related substances and application equipment for agricultural use must be inscribed in the registry that the State Phytosanitary Service (Servicio Fitosanitario del Estado) will create to have information available on their characteristics and to ensure their correct use in the country.

3°-That agricultural pesticides are fundamental for combating pests that affect agricultural production and for the competitiveness of agricultural producers; therefore, it is essential to guarantee the supply and continuity of commercialization of products that currently have a valid registration, making it necessary to update the information in their dossiers on their characteristics and to ensure their correct use in the country.

4°-That regulations prior to the entry into force of Executive Decree No. 33495 MAG-S-MINAE-MEIC of October 31, 2006 and its amendments, allowed the Ministry of Agriculture and Livestock (Ministerio de Agricultura y Ganadería) to grant indefinite-term registrations as well as the inscription of formulated pesticides without it being a requirement to have prior registration of the technical-grade active ingredient (IAGT), so it is necessary to update the information of these registrations and also establish a validity period equal to that of the registrations granted under current regulations.

5°-That international regulations establish toxicological, ecotoxicological, and environmental fate information requirements indicated in Executive Decree No. 33495-MAGS- MINAE-MEIC of October 31, 2006 and its amendments, which were not requested in previous regulations, making it necessary to extend the registrations granted before said executive decree so they can enter a registration process in accordance with the requirements of current regulations, while guaranteeing the continuity of their commercialization, given their importance as a tool for combating agricultural pests.

6°-That both the Food and Agriculture Organization of the United Nations (FAO) and the World Health Organization (WHO) recognize that the repetitive generation of studies and information regarding all potential/actual risks for each manufacturer of a pesticide can be unnecessary and ethically undesirable.

7°-That the Cost-Benefit Evaluation Form was completed in Section 1, called Prior Control of Regulatory Improvement, and it resulted negative and that the proposal has no procedures nor requirements." Meanwhile, the premises of the "Reform Regulation for updating the information in the registration dossiers of technical-grade active ingredient and formulated pesticides," No. 41481 – MAG, are as follows:

"CONSIDERING 1.- That through Executive Decree No. N° 39995-MAG of December 15, 2016, published in Gazette No. 11, Supplement No. of January 16, 2017, the Regulation for updating the information in the registration dossiers of technical-grade active ingredient and formulated pesticides is decreed.

2.- That the State Phytosanitary Service, hereinafter (SFE), following a consultation from its Internal Audit with the Attorney General's Office of the Republic (Procuraduría General de la República), suspended the application of Decree 39995-MAG and currently, due to lack of procedure, it has not been possible to update the information of any of the registrations of Technical-Grade Active Ingredients, hereinafter (IAGT), and of formulated products that do not have IAGT registration and that were not inscribed in accordance with Executive Decree N° 33495-MAG-SMINAE- MEIC of October 31, 2006 and its amendments.

3.- That the Attorney General's Office of the Republic, in response to the SFE Internal Audit consultation, issued opinion No. C-199-2017 of September 8, 2017, concluding regarding Executive Decree 39995-MAG that: "it is a revalidation of previous registrations, inscribed under other regulations and does not refer to an inscription procedure per se. Furthermore, as established in paragraph 6°, it seeks to set a validity period for these registrations that were previously indefinite." "Therefore, it does not follow from said Decree that it is a technical regulation, requiring a consultation procedure with the Technical Regulation Body. On the contrary, it is the development of the provisions in Article 23 of the Phytosanitary Protection Law (Ley de Protección Fitosanitaria).

4.- That both national legislation and international regulations establish that the confidential information provided by registrants in the processes of registration and updating of dossiers, due to its protection regime and commercial sensitivity, must be guarded by the authorities diligently and appropriately, to guarantee its inviolability and protection against misuse.

5.- That the international specifications and standards of first-world countries and regions, as well as internationally recognized and prestigious organizations, are a technical and scientific reference for determining that the technical-grade active ingredients synthesized by the manufacturers proposed in the dossier update processes do not contain relevant impurities at levels higher than international standards or specifications, and that relevant impurities are those with toxicological or ecotoxicological relevance, which can cause harm to health or the environment.

6.- That technical-grade active ingredients are used solely for the formulation of formulated synthetic chemical pesticides and that only by exception are they used directly in the field, and these exceptional situations are already regulated in the current technical regulations; therefore, the registration certificates of technical-grade active ingredients are only useful to authorize, by the State Phytosanitary Service, the importation of these as raw material for pesticide formulations in processing plants and not for direct field use.

7.- That Executive Decree 39995-MAG, repeatedly cited, established a twenty-four-month period for updating the Registration, which expires on January 16, 2019, and that currently a procedure that allows its application is not in place, so it is timely and convenient to establish a new reasonable period for the application of the decree in question and the procedures.

8- That the approval of the Directorate of Regulatory Improvement of the Ministry of Economy, Industry and Commerce (Ministerio de Economía, Industria y Comercio) has been obtained, according to Report DMR-DAR-INF-149-18, of December 6, two thousand eighteen." (The highlighting is not from the original).

In this way, it is reiterated that the regulation under examination applies only to old products, that is, products for which registrations of IAGT or formulated product have already been granted, and many of those registrations were granted for an indefinite period. This means that they do not require the update decree to continue commercializing. Because of this, rather than facilitating, the matter concerns imposing an obligation on them to update their information and provide data and studies that demonstrate not only the provenance and origin of the technical materials and associated formulations, but also to provide the confidential chemical information that allows the registration authority, namely the SFE, to have the confidential chemical information on purity, impurities, synthesis method, etc., of its technical materials available, regarding both manufacturers and formulators. It is precisely from the detail of the information provided that the registration authority can make regulatory decisions regarding the continuity or not of a registration or of a manufacturer of a technical material of a formulation marketed in Costa Rica. As emphasized supra, failure to undergo this registration update procedure may lead to action under Article 24 of the Phytosanitary Protection Law (Ley de Protección Fitosanitaria). Similarly, with the complete registration information, decisions can be made in light of what is expressly regulated in Article 30 of the same law:

"Art. 30.- Prohibitions and restrictions for technical reasons The Ministry of Agriculture and Livestock may restrict or prohibit the importation, transit, redestination, manufacturing, formulation, repackaging, re-wrapping, storage, sale, mixing, and use of chemical, biological, or related substances and application equipment for agricultural use, when justified for technical reasons and it is considered that using them is harmful to agriculture, health, or the environment".

It is observed that this police power empowers the State to evaluate products in light of updated information and adopt corresponding decisions in order to safeguard agriculture, health, or the environment.

Now, the complainant's grievance, beyond specifying aspects of the procedure in particular, focuses on questioning that, in his opinion, the Ministry of Health (Ministerio de Salud) and MINAE should intervene. However, as already examined supra, the fact that they did not participate in the adoption of the regulation, or in the procedure for updating the registration information, does not in any way per se imply a violation of the Constitution.

Now, although it was not detailed by the complainant in this section, it should be noted that the submission of information from other registration dossiers was endorsed by the majority of this Court in judgment No. 2022-26651, in light of the international technical legislation that allows it, for which reason, regarding these aspects, it is necessary to abide by what was said in the referenced vote.

VIII.- ON ARTICLE 1° OF THE DECREE The complainant claims that the partial reform and addition to Executive Decree No. 39995 is a benefit to pesticide marketers, as it extends the time from the publication of the challenged decree, granting the benefit of five more years to those products without them having undergone a risk assessment and granting that additional time for the registration holders to submit the information. Even though a taxative list of requirements is defined in this same paragraph, he considers them limited for conducting a risk assessment. He assumes that what the ministerial office pursues with the promulgation of this type of document is to demand, order, or intimidate the registration evaluators to limit themselves solely to requesting limited information, which lacks technical and scientific basis to conduct a risk assessment according to national and international standards with decimated requirements. He questions that in the article in question, the MAG again insists on the process of referenced information, without proprietary or referenced information, as proposed by this regulation. Thus, the Executive Branch and the pesticide industry seek to facilitate the trade of pesticides to the detriment of human and animal health and the environment.

Regarding this, the Minister of MAG explains that the challenged paragraph maintains its scope of application in the sense that it cannot be used to register new pesticides and the only thing that changes is related to the deadlines and one of the administrative requirements. Regarding the issue of deadlines, he considers it a matter of legality, as it is the responsibility of the competent authority to define the deadlines within which certain acts must be performed and the deadlines that the administered party must meet for their actions under the rule. On the other hand, it is insisted that the competences were delegated by the will of the legislator to the MAG through the SFE. From a technical and scientific point of view, the regulation allows the State to have all the information on purity, relevant impurities (name, content, and detection levels), total impurities, synthesis method, analytical methodologies to determine the IAGT and its relevant impurities, of all IAGTs registered as such or as components of a formulation, which were registered in Costa Rica under legislation and regulations different from Executive Decree No. 33495-MAG-S-MEIC-MINAET. The confidential chemical information required by this decree is key and essential, from an agronomic, toxicological, and ecotoxicological point of view, and unfortunately it is not incorporated into the dossiers of these registrations. Much of the chemical information requested in the decree, especially that described in Articles 1 and 5, although it was presented during the revalidation process, is completely outdated, as five to ten years have passed since the information was provided and the authorities have not yet reviewed it, much less approved it. Furthermore, it allows the Costa Rican State to have updated information on the formulation sites and origins, name and physical location of the formulators, as well as the components of the product and the detailed description of the formulation processes of all formulated products currently marketed in Costa Rica.

From a chemical and scientific point of view, it is guaranteed that no formulated pesticide marketed in Costa Rica can be registered, and therefore marketed, if it does not have an associated IAGT whose levels of relevant impurities (which are those with toxicological and ecotoxicological importance) exceed the levels specified in the international reference standards (FAO, EPSA, IUPAC).

The PGR considers that it lacks the competence to address the technical aspects and suitability of the requirements demanded to carry out the update of the registrations. However, it does point out that the Chamber must technically assess whether the requirements set forth by the challenged norm for the revalidation process allow for an adequate assessment of the environmental or health risk of the products, since, from a mere comparison of the texts of Decree No. 39995 and Decree No. 41841, it is verified that the technical requirements that Decree No. 33495 did contemplate were not added, but rather, some points were eliminated and modified. Furthermore, it points out that the challenged decree modifies Articles 1.2.b and 6 of Decree No. 39995, which allow the registration of products through referenced information, but maintains that possibility in several provisions and does not establish how the information will be verifiable, how to determine which international specification can be used, the way to determine product equivalence, or whether the reference profile to be used must be a registration that has complete information. By not precisely establishing the rules to which the competent authority must adhere to verify the information, it is possible to allow the update of registrations with referenced information that does not meet the indicated requirements and, therefore, subject to what is provided in the technical criteria issued, this would imply the update of product registrations without a prior assessment of the environmental and health risks of their application and the unconstitutionality of the articles that allow the use of referenced information without an adequate determination of equivalence.

In this regard, the Chamber considers that concerning what was reported by the PGR, it is appropriate to clarify the argument offered based on the explanations made by the Minister of MAG. The PGR stated that from a mere comparison of the texts of Decree No. 39995 and Decree No. 41841, it is verified that the technical requirements that Decree No. 33495 did contemplate were not added. However, as has been explained, said regulatory instruments regulate different situations, which would justify the demand for different requirements. Decree No. 33495 regulated all the inscription procedures for new products, while Decrees No. 39995 and No. 41841 regulate another, different factual situation, because they apply to products that are already registered and in use in the national territory, but for which an update of their registrations must be carried out. This would justify the differentiated treatment questioned by the PGR.

Now, in addressing the complainant's grievances, it must be indicated that the extension of the deadline is due to a practical situation that was justified in the considerations of the decree. That is, the application of the previous decree was suspended by virtue of an administrative decision that paralyzed the procedure that was underway:

"The State Phytosanitary Service, hereinafter (SFE), following a consultation from its Internal Audit with the Attorney General's Office of the Republic, suspended the application of Decree 39995-MAG and currently, due to lack of procedure, it has not been possible to update the information of any of the registrations of Technical-Grade Active Ingredients, hereinafter (IAGT), and of formulated products that do not have IAGT registration and that were not inscribed in accordance with Executive Decree N° 33495-MAG-SMINAE- MEIC of October 31, 2006 and its amendments." (The highlighting is not from the original).

The foregoing justifies the claimed extension of the deadline.

Subsequently, the complainant's allegation reduces to stating that the requirements are limited and that they involve a way of intimidating the registrar so that they do not request more information from the petitioners. Said argument lacks adequate and reasonable substantiation, as it does not detail which requirements he considers insufficient. Moreover, regarding the application, it is merely a subjective appreciation of an eventual consequence of the rule, which has no basis in an objective element derived from the clause under analysis. Nor does the complainant's presumption that these norms seek to facilitate the work of traders have such a basis, all of which was rejected and justified in the MAG report. Therefore, this Chamber considers that these grievances must be dismissed.

Regarding the referenced information, this Court in judgment **n.°2022-26651,** as has been stated, conducted an analysis of the international technical legislation that allows for the submission of information from other registration files and concluded that the possibility of using referenced information from non-national authority registries, for processing registration procedures, is not unconstitutional, because it is justified by the international technical and scientific instruments that this judgment points out. For this reason, regarding these aspects, it is necessary to abide by what was stated in the aforementioned decision and dismiss the grievances.

**IX.- REGARDING ART. 2** **The petitioner** claims that the proposed reform reduces the time for evaluators to make a decision, changing from three months defined in executive decree n.°39995 to one month in the modification set forth in decree n.°41481-MAG. They argue that this demonstrates that this type of regulation seeks to benefit agrochemical selling companies, so that registration analysts perform the analysis pressed for time, without having a workload study to determine the proposed timeframe. They add that what is most serious is that the analysis proposed in this decree is defined as a simple verification of chemical documents, that is, whether the registrants submitted the information or not, but the degree of lack of coordination is such that this verification of documents, which are chemical in nature, is assigned to agronomy professionals, who do not have the competencies or training to perform this task. This proposed plan is a new registration modality carried out only with a simple "check list" or verification list.

The **Minister of MAG** maintains that on this point, the petitioner merely objects to matters of mere legality and fails to address the alleged unconstitutionalities of the rule they challenge. They point out that, even by a pure and simple reading of the text, it is evident that the petitioner's assertion that registrations are being granted to new products through this regulatory provision is fallacious. They add that it is also not true, as the petitioner asserts, that agronomists are in charge of reviewing the chemical information; but beyond the inaccuracies and fallacies the petitioner incurs in, it is clear that their arguments are about administrative aspects and matters of mere legality that are not for the Constitutional Chamber to resolve but for the ordinary jurisdiction.

The **PGR** considers that the unconstitutionality of art. 2 should be declared if, based on the technical criteria submitted to the file, it is determined that reducing the deadline from three months to one month, for the SFE to verify and analyze the submitted information and resolve the product update application and grant the registration certificate, prevents an adequate assessment of the product's environmental and health risk. They add that, without prejudice to what is resolved regarding that article, it is advisable for the Constitutional Chamber to clarify whether the rule applies that the figure of positive silence (silencio positivo) does not operate in the case of environmental approvals or authorizations and that, therefore, the Administration's failure to comply with the established deadline would not imply the automatic approval of the product's renewal.

The **current rule** compared to the original decree establishes the following:

For the **Chamber**, the arguments of unconstitutionality lack adequate grounding. The mere fact that resolution deadlines are reduced does not mean that this procedure itself is less protective of rights or harmful to constitutional provisions. It must be understood that, by virtue of the constitutional principles that must govern the functioning of the entire Public Administration, the SFE authorities—as legally designated for the resolution of this type of procedure—must resolve the registration update application efficiently and promptly; but, in the same way, they have the paramount obligation to ensure phytosanitary protection as a matter of public interest.

It is also worth highlighting that many of the grievances raised by the petitioner stem from a generic premise that the requirements are not sufficient and that the means are being facilitated so that, in their application (reduction of deadlines and competent authority), the merchants of these products are favored. In this regard, this court observes that there is no appropriate grounding on the issue of requirements (which ones yes and which ones no) and the petitioner does not refer to the eventual way in which the Administration (SFE) will exercise its powers. This, moreover, would not be the subject of an unconstitutionality action, but of a control that must be carried out by the entire Public Administration and the ordinary jurisdiction, so that legally assigned powers are exercised with rigor and efficiency.

There is also no evidence in the challenged rule that this evaluation is carried out by agronomy professionals and that they lack the competencies or the necessary expertise to make an appropriate assessment of the documentation submitted, always safeguarding the environment and people's health.

Regarding what is stated by the PGR, this Chamber considers that their presumptions also stem from a mistaken premise, because they refer to "granting the registration certificate"; however, as has been explained, the regulation in question does not properly regulate the registration of products, since they are already on the market, but rather what is required is the updating of all the information in their registrations. Now, concerning the request for clarification made by the PGR, this Court considers it clear that for everything related to registration—which is not the case for the regulation under analysis—or to the updating of information in registries, the institute of positive silence (silencio positivo) is not applicable. In our legislation, the application of positive silence has been permitted—from the moment the application has been submitted with its formal requirements, before the competent body and in the manner required by law—only for those procedures of the administered party that are related to licenses, permits, authorizations, or when a specific rule explicitly authorizes it. The purpose of this legal figure is to provide the administered party with a regulated and swift way to resolve their requests when, for one reason or another, the Administration has delayed in providing legal certainty on what was required. However, for a long time, this Court has been emphatic in pointing out that in environmental matters—not only for the protection of the environment itself, but also for the impact it has on people's health—positive silence does not operate. For example, since judgment **n.°1994-6332**, the following has been considered:

*"The point under discussion in this amparo appeal (recurso de amparo) is the applicability or not of the legal figure of positive silence with respect to the license or authorization requested—by the appellant—for the scientific collection of scarlet macaws. In this regard, this constitutional body has maintained that, in general terms, positive silence operates in the face of the Administration's inertia and in those cases where the petitioner has met all the requirements for its granting, **the truth is that the protection and preservation of the integrity of the natural environment is a fundamental right, so it cannot be understood that positive silence proceeds simply because the deadline within which the Administration should have ruled** on the permit for obtaining wild individuals of 'Ara Macao' for scientific conservation purposes in the Central Pacific region has elapsed. Hence, the Pro Iguana Verde Foundation cannot derive subjective rights through the application of the aforementioned legal institute, since the public interest represented by the State in its obligation to ensure the right of every person to enjoy a healthy and ecologically balanced environment predominates over the private interest of wildlife exploitation."* (Criterion reiterated in judgments numbers 1999-01149, 2000-01375 and 2006-14479).

Such considerations were replicated by this Chamber in judgment **n.°2016-017375** which concluded the following: "it has also been clearly asserted that in this environmental matter, the figure of positive silence does not operate either." In matters of medication registration—which clearly has an impact on people's health—the Chamber has also warned of the inapplicability of positive silence. In judgment **n.°2006-000688**, the following reflections were expressed:

*"The importance enshrined in this precious right, as well as the duty of the Administration granted at the constitutional level to ensure its protection, allows us to conclude that it would be contrary to the Social State of Law (Estado Social de Derecho) advocated by our Magna Carta to allow the application of the concept of positive silence in matters of medication registration. This Constitutional Court considers that the aforementioned medication registration procedure carried out by the Ministry of Health requires meticulous technical analysis that allows for a certain conclusion as to whether the product in question does not represent a danger to the health of the country's inhabitants; for this reason, it is essential that this process is carried out efficiently. Faced with the above arguments, this Chamber considers it necessary to clarify that the figure of positive silence, especially in cases like the present one, could in no way be conceived as the simple lapse of the deadline within which the Administration should have ruled on a matter; this is because the protection of the right to health is at stake (in this sense, see resolution No. 1999-1149 of 7:33 p.m. on February 17, 1999)."* The jurisprudential guidelines of this Chamber in environmental matters were collected in the Forestry Law (Ley Forestal) n.°7575 of April 16, 1996, which indicates the following:

*"Art. 4.- Positive silence* ***In matters of natural resources, positive silence shall not operate**, as contemplated in articles 330 and 331 of the General Law of Public Administration (Ley General de la Administración Pública).* *When the State Forestry Administration does not resolve matters submitted to its knowledge within the deadlines stipulated in the General Law of Public Administration, the responsible official shall be subject to the sanctions provided in the laws."* (Thus amended by article 1° of law n.°10072 of November 18, 2021. The highlighting does not correspond to the original).

Likewise, they were collected in the recent reform made to the Law for the Protection of Citizens from the Excess of Administrative Requirements and Procedures (Ley de Protección al ciudadano del exceso de requisitos y trámites administrativos) n.°8220, which where applicable warns the following:

*"**Excepted from the application of positive silence are licenses, permits, and authorizations in matters of public health and the environment** and those matters in which, by constitutional, legal provision, or judicial jurisprudence, it is expressly indicated. Each institution must expressly indicate, in the National Catalog of Procedures (Catálogo Nacional de Trámites), for which specific cases this figure is not applicable, under penalty of incurring an administrative fault on the part of the Procedure Simplification officer."* (The highlighting does not correspond to the original).

Therefore, in accordance with the reiterated jurisprudence of this Chamber and the current legal regulations, it is understood that regarding procedures related to the registration or updating of pesticides, due to their clear impact on the environment and people's health, the administrative figure of positive silence does not apply.

Finally, it is worth emphasizing that if the trading parties do not comply with this procedure for updating requirements within the established deadlines, the Administration is authorized to apply the pertinent legal provisions and the registration can be canceled (art. 24), and the person is exposed to the corresponding fines (art. 76, both of the Phytosanitary Protection Law).

**X.-** **REGARDING ART. 3** The **petitioner** states that, again, the ministerial office shortens the time established in executive decree n.°39995 for the benefit of users, without knowing if there is a technical workload study to support such a decision to go from three months to ten days for the technical evaluation to be carried out by SFE officials, as this decree unilaterally excludes the participation of the corresponding ministries in health and environmental matters.

They specifically question the paragraph that states that "for formulated pesticides that do not have a registration of a technical grade active ingredient associated with that formulation and whose formulator has been updated in accordance with this regulation, the SFE will grant the registration certificate for the technical grade active ingredient." They consider that this decree opposes any active technical-scientific principle governing registration matters, as it is granting a registration without even mediating the basic process governing registration regulations, which is chemical evidence.

Regarding this article, the **Minister of MAG** reiterates their technical explanation of the purpose of this regulation:

*"As we had already pointed out, in Costa Rica, before January 10, 2007, the registration system established that a formulation could be registered without needing to have a registration of the raw material, that is, its technical grade active ingredient (TGAI). After that date, it was established that every formulation, prior to being registered, required the registration of its TGAI. This means that currently, an enormous number—around fifteen hundred formulated products—are not associated with a manufacturer. That is why Executive Decree N° 39995-MAG of December 15, 2016, and its reform (Executive Decree N° 41481-MAG of December 10, 2018, published January 11, 2019, supplement number 8 of the Official Gazette La Gaceta), establishes an update process that will allow the registration system to guarantee that every formulation marketed in the country will be associated with a TGAI manufacturer, so that this update of the manufacturer does not imply that registration is being granted to a new product, but rather that through this update process, the authority will have the necessary information to determine if the technical material with which that formulated product is made does not contain relevant impurities and that it also meets the international specification that every TGAI must meet for the formulation of pesticides. Thus, what the petitioner indicates regarding the lack of technical or scientific basis and the confusion they make with registration under the equivalence modality is incorrect, because the process does not propose an equivalence but an update of the information of a current registration of a formulated product that does not have a TGAI manufacturer associated with its registration, recalling that by virtue of article 3, it is not that a new product is being authorized but rather associating a manufacturer to that formulation that already has registration and is marketed in the country."* Furthermore, they state that the questions regarding aspects of deadlines and workloads are discussions of mere legality and not of constitutionality.

The **rule** in question, comparatively with the previous one, provides as follows:

Regarding the grievances raised, the **Chamber** observes that the arguments about the definition of time limits and the SFE's workloads and the exception to the participation of the Ministries of Health and Environment and Energy have already been addressed in the previous sections. The mere circumstance that resolution time limits are reduced does not in itself imply an injury to the Law of the Constitution, and the fact that the competencies for updating registrations are concentrated in the SFE is a consequence of a legal provision (art. 23 of the Ley del Servicio Fitosanitario del Estado), which does not in itself appear unconstitutional nor has it been challenged.

With respect to the registration, the explanations of the minister must be revisited, in the sense that this procedure does not imply, as such, granting a new registration, but rather updating all the missing information on the product and that this allows the authorities to determine whether it contains relevant impurities that merit some kind of reassessment of the registration. As has been repeatedly emphasized, the procedure regulated by the regulations under review is for products that are already registered and on the market (an administrative authorization already exists), so that information is requested for the purpose of its re-evaluation. Furthermore, as seen in the reports transcribed in this judgment, previously the validity of registrations was provided for indefinitely, whereas under the regulations under analysis, caps and limits on that registration are introduced.

**XI.- ON ART. 4** (which amends art. 5 of decree No. 39995) The **claimant** insists that the registration facilitation process established by executive decree No. 41481 goes against the State's duty to protect all of Costa Rican society. He considers that only requirements to get by are listed, and that they will not support any information to conduct a technical-scientific risk analysis evaluation.

The **Minister of MAG** explains that in analyzing art. 5, the claimant confuses the concept of manufacturer with that of formulator, such that the entire hypothesis, objections, and analyses he makes of said rule are not applicable to the legal situation regulated by the updating of formulators under executive decree No. 39995-MAG of December 15, 2016 and its amendment No. 41481-MAG.

The rule in question, comparatively with the previous one, provides as follows:

In the opinion of the **Chamber**, the claimant does not properly substantiate the reasons why he considers that the requirements demanded therein "will not support any information to conduct a technical-scientific risk analysis evaluation." This is a generic argument, so this Court cannot conduct a rigorous constitutional examination in this regard.

Furthermore, it is necessary to reiterate this Chamber's criterion in judgment No. 2009-008917, which established the following:

"Firstly, the claimants request that the unconstitutionality of articles 1, 7 and 8 of Law No. 8702, called Procedure for Agrochemical Registration Applications, be declared, arguing that the law does not require a series of essential technical requirements that, in their judgment, must be required in order to register an agrochemical, and that these omissions contravene the fundamental rights to health and a healthy and ecologically balanced environment. In this regard, it is worth mentioning that although this Constitutional Court is empowered to act as a negative legislator, with the power to annul from the legal system all those norms it considers unconstitutional, the truth is that it is prevented from acting as a positive legislator creating norms. On the other hand, even though this Chamber is competent to hear legislative omissions as established in article 73 of the Ley de la Jurisdicción Constitucional, it is important to clarify that not every normative omission can be challenged through this procedure. In that sense, only those omissions that occur as a consequence of an express and direct mandate contained in the Law of the Constitution can be subject to constitutional control by way of action. Now, in the specific case, the omissions challenged by the claimants do not come from an express mandate of the constituent; rather, they are omissions that they claim to find in the text of the law, without the duty to legislate in the sense explained by the actors coming from the Political Constitution. Likewise, as this is a Court that acts as a negative legislator, it is clear that a possible sustaining ruling, with the consequent elimination of the norm, would not repair the omissions indicated by the claimants, so the action filed in those terms lacks utility and is therefore manifestly improper. On the other hand, it is observed that, **in essence, what the claimants seek is for this Chamber to determine whether the requirements that the norms demand for the registration of an agrochemical are technically and scientifically appropriate or not, and, in the event they are not, to rule on the list of requirements that, in their judgment, the regulations should contain. However, it is necessary to indicate that this Court is not the competent body to exercise that function, as this is a competence assigned to the legislator, who, in use of their discretionary powers, is responsible for designing the legal procedures and requirements that must be met for the registration of agrochemicals in the country.** Only in those cases where the legislator exceeds that discretionary power to the direct detriment of the fundamental rights of individuals can this Chamber validly hear and rule on the matter. However, as what is challenged in this case is not the text of the norms themselves or the legislator's discretion, but rather what the actors consider the law omits, this Court cannot rule in order to supplant competencies and establish those requirements. Under such circumstances, the action is inadmissible." (The highlighting does not correspond to the original).

It is appropriate to replicate this *ratio* in the specific case insofar as, as noted, there is no precision in the claimant's reasoning and the Chamber cannot attribute to itself the power to make technical and scientific determinations on whether the requirements demanded in the numeral in question are or are not sufficient to fulfill the legislator's mandate and the constitutional mandates derived from art. 21, 46 and 50 of the Constitution.

**XII.- On art. 5** (which amends art. 6 of decree No. 39995) The **claimant** affirms that the chemical equivalence process proposed in this article contravenes international standards, Constitutional Chamber judgment No. 2011-016937 and the reports of the CGR. He argues that a procedure for evaluating equivalence in formulated products has not been proposed by these institutions. Furthermore, he questions that the database does not constitute any solution.

The **Minister of MAG** responded to these grievances explaining that art. 6 of the challenged decree guarantees, in its current wording, first, that Costa Rica will no longer have registrations for an indefinite period, because as of the update, all registrations of technical grade active ingredient (IAGT) and formulated products will have a validity of ten years, imposing the obligation to renew them, unlike now where, being for an indefinite period, they do not have to be renewed because they lack an expiration date; second, that all the formulations currently sold on the market will have an associated manufacturer, unlike now where the manufacturing sites and origins of the raw materials are unknown; third, that every IAGT used in Costa Rica for the formulation of products authorized for commercialization in Costa Rica has proven its purity and has no relevant impurities exceeding the international specification; fourth, that all IAGTs used in Costa Rica comply with the international conventions signed by Costa Rica (Annex III of the Rotterdam Convention, the Stockholm Convention, or the Montreal Protocol); and fifth, that the SFE will create a database of toxicological, ecotoxicological and environmental fate information for the technical grade active ingredients that are registered and do not have current periods of protection for test data. He affirms that it is very important for the SFE to have an information bank for molecules that are not new and whose test data are free for use, not having current periods of protection.

Furthermore, it is necessary that companies holding toxicological, ecotoxicological, and environmental fate information on technical-grade active ingredients that are not new provide information they have managed to compile, which may serve so that in the future the SFE can gradually build a complete toxicological, ecotoxicological, and environmental fate and behavior profile, allowing for a reference profile for registrations by equivalence.</span></p><p style="margin-top:0pt; margin-bottom:0pt; text-align:justify; line-height:150%; font-size:14pt"><span style="font-family:'Times New Roman'">In this regard, the PGR maintained that by not precisely establishing the rules to which the competent authority must adhere to verify the information, it is possible that the updating of registrations may be permitted with referenced information that does not meet the indicated requirements, and therefore, this would imply the updating of product registrations without a prior assessment of the environmental and health risks of their application. Should the foregoing be confirmed, according to the technical criteria issued to that effect, it would imply the unconstitutionality of the articles that allow the use of referenced information without an adequate determination of equivalence.</span></p><p style="margin-top:0pt; margin-bottom:0pt; text-align:justify; line-height:150%; font-size:14pt"><span style="font-family:'Times New Roman'">The rule in question, compared with the previous one, provides the following:</span></p><table cellspacing="0" cellpadding="0" style="width:440.2pt; border:0.75pt solid #000000; -aw-border:0.5pt single; border-collapse:collapse" class="mce-item-table"><tbody><tr><td style="width:194.7pt; border-right-style:solid; border-right-width:0.75pt; border-bottom-style:solid; border-bottom-width:0.75pt; padding-right:5.03pt; padding-left:5.03pt; vertical-align:top; -aw-border-bottom:0.5pt single; -aw-border-right:0.5pt single"><p style="margin-top:0pt; margin-bottom:0pt; text-align:justify; font-size:11pt"><span style="font-family:'Times New Roman'; font-weight:bold">Regulation for Updating Information in the Registration Dossiers of Technical-Grade Active Ingredient and Formulated Pesticides, No. 39995-MAG</span></p><p style="margin-top:0pt; margin-bottom:0pt; text-indent:35.4pt; text-align:justify; font-size:11pt"><span style="font-family:'Times New Roman'; font-weight:bold; -aw-import:ignore">&nbsp;</span></p></td><td style="width:223.1pt; border-left-style:solid; border-left-width:0.75pt; border-bottom-style:solid; border-bottom-width:0.75pt; padding-right:5.03pt; padding-left:5.03pt; vertical-align:top; -aw-border-bottom:0.5pt single; -aw-border-left:0.5pt single"><p style="margin-top:0pt; margin-bottom:0pt; text-align:justify; font-size:11pt"><span style="font-family:'Times New Roman'; font-weight:bold">Reform of the Regulation for Updating Information in the Registration Dossiers of Technical-Grade Active Ingredient and Formulated Pesticides, No. 41481 – MAG</span></p></td></tr><tr><td style="width:194.7pt; border-top-style:solid; border-top-width:0.75pt; border-right-style:solid; border-right-width:0.75pt; padding-right:5.03pt; padding-left:5.03pt; vertical-align:top; -aw-border-right:0.5pt single; -aw-border-top:0.5pt single"><p style="margin-top:0pt; margin-bottom:0pt; text-align:justify; font-size:11pt"><span style="font-family:'Times New Roman'; font-weight:bold">ART. 6</span></p><p style="margin-top:0pt; margin-bottom:0pt; text-align:justify; font-size:11pt"><span style="font-family:'Times New Roman'">Registrations that have not been granted in accordance with Executive Decree 33495-MAG-S-MINAE-MEIC of October 31, 2006, and its reforms, and that have complied with the provisions of this Decree, shall have a validity of ten years from the moment the Competent Authority approves the update. During this period, they must enter a registration process in accordance with what the current regulations indicate.</span></p><p style="margin-top:0pt; margin-bottom:0pt; text-indent:35.4pt; text-align:justify; font-size:11pt"><span style="font-family:'Times New Roman'">In the event that there is no reference profile for its registration by equivalence, the registration holder may provide referenced information from scientific literature or databases approved by the CA, in order to complete the chemical, toxicological, ecotoxicological (ecotoxicológica), and environmental fate information, as a basis for registration.</span></p><p style="margin-top:0pt; margin-bottom:0pt; text-align:justify; font-size:11pt"><span style="font-family:'Times New Roman'; -aw-import:ignore">&nbsp;</span></p></td><td style="width:223.1pt; border-top-style:solid; border-top-width:0.75pt; border-left-style:solid; border-left-width:0.75pt; padding-right:5.03pt; padding-left:5.03pt; vertical-align:top; -aw-border-left:0.5pt single; -aw-border-top:0.5pt single"><p style="margin-top:0pt; margin-bottom:0pt; text-align:justify; font-size:11pt"><span style="font-family:'Times New Roman'; font-weight:bold">ART. 6</span><span style="font-family:'Times New Roman'; font-weight:bold">&nbsp;</span></p><p style="margin-top:0pt; margin-bottom:0pt; text-align:justify; font-size:11pt"><span style="font-family:'Times New Roman'">The registrations of technical-grade active ingredient or formulated product that have been updated in accordance with the provisions of this regulation shall have a validity of ten years, starting from when the Competent Authority issues the new registration certificate. During this period, the SFE will verify that the updated registrations of technical-grade active ingredient have chemical equivalence with the reference profile of that technical-grade active ingredient, and in the absence thereof, will verify that they do not contain relevant impurities at levels higher than international standards or specifications, as well as that the technical-grade active ingredient is not included in Annex III of the Rotterdam Convention, in the Stockholm Convention, or in the Montreal Protocol.</span></p><p style="margin-top:0pt; margin-bottom:0pt; text-indent:35.4pt; text-align:justify; font-size:11pt"><span style="font-family:'Times New Roman'">The SFE shall create a database of toxicological, ecotoxicological (ecotoxicológica), and environmental fate information for the technical-grade active ingredients that are registered and that do not have current periods of protection for test data.</span></p><p style="margin-top:0pt; margin-bottom:0pt; text-align:justify; font-size:11pt"><span style="font-family:'Times New Roman'; font-style:italic">(As reformed by Article 5 of Executive Decree No. 41481 of December 10, 2018)</span></p><p style="margin-top:0pt; margin-bottom:0pt; text-align:justify; font-size:11pt"><span style="font-family:'Times New Roman'; -aw-import:ignore">&nbsp;</span></p></td></tr></tbody></table><p style="margin-top:0pt; margin-bottom:0pt; text-align:justify; line-height:150%"><span style="font-family:'Times New Roman'; -aw-import:ignore">&nbsp;</span></p><p style="margin-top:0pt; margin-bottom:0pt; text-align:justify; line-height:150%; font-size:14pt"><span style="font-family:'Times New Roman'">In relation to the plaintiff's arguments, this Chamber considers them to be neglectful and confusing and that it is not appropriate to supply the argumentation that the plaintiff would be responsible for making. This Court has already warned as follows:</span></p><p style="margin-top:0pt; margin-left:28.35pt; margin-bottom:0pt; text-align:justify"><span style="font-family:'Times New Roman'; font-style:italic">“The Chamber could not, for example, engage in judicial activism or replace the plaintiff in their duty to argue. For this reason, also, the judgment must be ‘… congruent with what was sought …’ in the filing brief.”</span><span style="font-family:'Times New Roman'"> (Judgment No. 2022-026592). </span></p><p style="margin-top:0pt; margin-bottom:0pt; text-align:justify; line-height:150%"><span style="font-family:'Times New Roman'; -aw-import:ignore">&nbsp;</span></p><p style="margin-top:0pt; margin-bottom:0pt; text-align:justify; line-height:150%; font-size:14pt"><span style="font-family:'Times New Roman'">In the sub lite, the plaintiff indicates that there is no procedure for the evaluation of equivalence; however, they fail to specify in which instruments it is required that, additionally, the authorities must detail a procedure for the evaluation of equivalence, which prevents this Chamber from conducting a rigorous analysis of the matter. In any case, this mechanism, that of using reference profiles, was examined in another action that was dismissed in judgment No. 2022-26651. It was also extensively assessed in judgment No. 2022-023238, in which it was explained that this is not an automatic procedure, but rather requires adequate analysis and justification, which must be controlled in each specific case. Consequently, this Chamber refers to the considerations made in those resolutions. </span></p><p style="margin-top:0pt; margin-bottom:0pt; text-align:justify; line-height:150%; font-size:14pt"><span style="font-family:'Times New Roman'">Additionally, it is noted that the regulation under analysis also requires that, in the absence of the equivalence report, it be verified that the IAGT does not contain relevant impurities at levels higher than international standards or specifications, as well as that the technical-grade active ingredient is not included in Annex III of the Rotterdam Convention, in the Stockholm Convention, or in the Montreal Protocol. Thus, standards for carrying out the analysis in question are expressly established. The authorities of the SFE, as has been warned, must be diligent and demanding in this matter given that people's health and a healthy and ecologically balanced environment are at stake. Therefore, in the registration and information update process, said authorities are obligated to apply the highest standards of protection to these fundamental rights and to be respectful of the precautionary principle. Likewise, they are obligated to keep updated and to adjust to technical developments or international standards in phytosanitary protection. Indeed, as already noted supra and it bears insisting, this Chamber draws attention to warn that—at the slightest trace of doubt—they must require all pertinent documentation or studies, with the purpose of verifying that the product for which the registration is to be updated complies with the parameters and conditions necessary to safeguard human health and food safety. Likewise, they are required to ensure that its use is appropriate and has the desired effects. Rigor in the selection of studies is as important as the subsequent controls that can be carried out in the application and use of the products.</span></p><p style="margin-top:0pt; margin-bottom:0pt; text-align:justify; line-height:150%; font-size:14pt"><span style="font-family:'Times New Roman'">Consequently, from what was pointed out by the plaintiff, no injury to the Law of the Constitution is proven. </span></p><p style="margin-top:0pt; margin-bottom:0pt; text-align:justify; line-height:150%; font-size:14pt"><span style="font-family:'Times New Roman'; font-weight:bold; text-transform:uppercase">Xiii.- Regarding art. 6 (</span><span style="font-family:'Times New Roman'; font-weight:bold">which reforms art. 7 of decree no. 39995</span><span style="font-family:'Times New Roman'; font-weight:bold; text-transform:uppercase">)</span></p><p style="margin-top:0pt; margin-bottom:0pt; text-align:justify; line-height:150%; font-size:14pt"><span style="font-family:'Times New Roman'">The plaintiff accuses this article of containing an unscientific registration proposal, which departs from national and international standards, and could be unconstitutional for violating the precautionary principle. They argue that the Executive Branch promulgated this decree which, in line with its objective, should have been titled “regulations for registration facilitation,” where the priority is the updating or renewal of registration with referenced information, pressuring registration analysts by shortening response times, proposing the registration process with only a simple verification of information, and separating the Ministries of Health and Environment in their registration analysis. </span></p><p style="margin-top:0pt; margin-bottom:0pt; text-align:justify; line-height:150%; font-size:14pt"><span style="font-family:'Times New Roman'">The Minister of MAG states that the current text bears no relation or congruence with the reckless comments and assertions made by the plaintiff about this specific article. Regarding the assertion that this rule reverses the principle of the burden of proof or the precautionary principle, they reject it “absolutely and categorically,” not only because it is a matter of legality to be discussed in ordinary jurisdiction, but also because the current text of Art. 7 is supported by repeated opinions of the PGR and by judgments of the Constitutional Chamber. They reiterate that it is incorrect and reckless to indicate, as the plaintiff does, that the questioned decree transgresses the precautionary principle in environmental matters, just as it is also incorrect to assert, as the plaintiff does in this fact and in their pleadings, that the burden of proof is reversed. </span></p><p style="margin-top:0pt; margin-bottom:0pt; text-align:justify; line-height:150%; font-size:14pt"><span style="font-family:'Times New Roman'">They note that the regulation under action does not allow or make it possible to grant registrations for new products to those already marketed, because its scope of application is very clear and is only feasible to apply it to current registrations that were granted under regulations (legal or regulatory) different from Executive Decree No. 3495-MAG-SMINAE-MEIC and its reforms. They add that with this regulation, registrations for IAGT and much less for formulations not already on the market will not be granted. Regarding the registered agrochemicals that are currently marketed in the country, there is no additional or resulting danger from its application, regarding human health, the environment, or the biological efficacy of the pesticide. Therefore, it is not correct to maintain that, with the application of the decree, the registrations updated in their dossiers pose an additional risk to health, the environment, or agriculture, since all, absolutely all the IAGT registrations granted, must necessarily and inevitably correspond to one of the formulations already sold on the market, and over these formulations, the Ministries of Health or Environment have broad and indisputable competences and powers to adopt pertinent measures to prevent damage to health or the environment.</span></p><p style="margin-top:0pt; margin-bottom:0pt; text-align:justify; line-height:150%; font-size:14pt"><span style="font-family:'Times New Roman'">The PGR reiterates that this does not undermine the constitutional duty that, by virtue of the precautionary principle, the competent authorities have to apply the powers set forth in Arts. 25 and 30 of the Ley de Protección Fitosanitaria and Art. 5 of the Ley para la Importación y Control de la Calidad de Agroquímicos, to “deny, suspend, or cancel the registration of chemical, biological, or related substances,” “restrict or prohibit the importation, transit, redestination, manufacturing, formulation, repackaging, storage, sale, mixing, and use of chemical, biological, or related substances and application equipment for agricultural use, when justified for technical reasons,” and “prohibit the circulation or order the destruction of products that do not comply with quality standards, as well as take other measures aimed at improving the quality of agrochemicals.</span></p><p style="margin-top:0pt; margin-bottom:0pt; text-align:justify; line-height:150%; font-size:14pt"><span style="font-family:'Times New Roman'">The rule in question, compared with the previous one, provides the following:</span></p><table cellspacing="0" cellpadding="0" style="width:440.2pt; border:0.75pt solid #000000; -aw-border:0.5pt single; border-collapse:collapse" class="mce-item-table"><tbody><tr><td style="width:194.7pt; border-right-style:solid; border-right-width:0.75pt; border-bottom-style:solid; border-bottom-width:0.75pt; padding-right:5.03pt; padding-left:5.03pt; vertical-align:top; -aw-border-bottom:0.5pt single; -aw-border-right:0.5pt single"><p style="margin-top:0pt; margin-bottom:0pt; text-align:justify; font-size:11pt"><span style="font-family:'Times New Roman'; font-weight:bold">Regulation for Updating Information in the Registration Dossiers of Technical-Grade Active Ingredient and Formulated Pesticides, No. 39995-MAG</span></p><p style="margin-top:0pt; margin-bottom:0pt; text-indent:35.4pt; text-align:justify; font-size:11pt"><span style="font-family:'Times New Roman'; font-weight:bold; -aw-import:ignore">&nbsp;</span></p></td><td style="width:223.1pt; border-left-style:solid; border-left-width:0.75pt; border-bottom-style:solid; border-bottom-width:0.75pt; padding-right:5.03pt; padding-left:5.03pt; vertical-align:top; -aw-border-bottom:0.5pt single; -aw-border-left:0.5pt single"><p style="margin-top:0pt; margin-bottom:0pt; text-align:justify; font-size:11pt"><span style="font-family:'Times New Roman'; font-weight:bold">Reform of the Regulation for Updating Information in the Registration Dossiers of Technical-Grade Active Ingredient and Formulated Pesticides, No. 41481 – MAG</span></p></td></tr><tr><td style="width:194.7pt; border-top-style:solid; border-top-width:0.75pt; border-right-style:solid; border-right-width:0.75pt; padding-right:5.03pt; padding-left:5.03pt; vertical-align:top; -aw-border-right:0.5pt single; -aw-border-top:0.5pt single"><p style="margin-top:0pt; margin-bottom:0pt; text-align:justify; font-size:11pt"><span style="font-family:'Times New Roman'; font-weight:bold; background-color:#ffffff">ART.</span><span style="font-family:'Times New Roman'; font-weight:bold; background-color:#ffffff">&nbsp;</span><span style="font-family:'Times New Roman'; background-color:#ffffff">7</span></p><p style="margin-top:0pt; margin-bottom:0pt; text-align:justify; font-size:11pt"><span style="font-family:'Times New Roman'; background-color:#ffffff">During the validity period of a registration, when the competent Ministries demonstrate an unacceptable risk to human health, the environment, or agriculture, the Servicio Fitosanitario del Estado shall restrict or prohibit its use.</span></p></td><td style="width:223.1pt; border-top-style:solid; border-top-width:0.75pt; border-left-style:solid; border-left-width:0.75pt; padding-right:5.03pt; padding-left:5.03pt; vertical-align:top; -aw-border-left:0.5pt single; -aw-border-top:0.5pt single"><p style="margin-top:0pt; margin-bottom:0pt; text-align:justify; font-size:11pt"><span style="font-family:'Times New Roman'; font-weight:bold">ART. 7</span></p><p style="margin-top:0pt; margin-bottom:0pt; text-align:justify; font-size:11pt"><span style="font-family:'Times New Roman'">During the validity period of a registration, when the SFE verifies that any of the active ingredients technical grade or formulations with a current registration pose an unacceptable risk to human health, the environment, or agriculture, it shall initiate ex officio the corresponding procedure for the annulment of the registration in accordance with the provisions of the current legal system, as well as the actions that seek the protection of health and the environment in accordance with the provisions of Articles 2 subsection e, 5 subsection o, 30, subsequent and concordant articles of the Ley de Protección Fitosanitaria.</span></p><p style="margin-top:0pt; margin-bottom:0pt; text-align:justify; font-size:11pt"><span style="font-family:'Times New Roman'; font-style:italic">(As reformed by Article 6 of Executive Decree No. 41481 of December 10, 2018)</span></p><p style="margin-top:0pt; margin-bottom:0pt; text-indent:35.4pt; text-align:justify; font-size:11pt"><span style="font-family:'Times New Roman'; font-weight:bold; -aw-import:ignore">&nbsp;</span></p></td></tr></tbody></table><p style="margin-top:0pt; margin-bottom:0pt; text-align:justify; line-height:150%"><span style="font-family:'Times New Roman'; -aw-import:ignore">&nbsp;</span></p><p style="margin-top:0pt; margin-bottom:0pt; text-align:justify; line-height:150%; font-size:14pt"><span style="font-family:'Times New Roman'">In the opinion of the Chamber, contrary to what was stated by the plaintiff, which in reality is a reiteration of the previous defects already examined, the rule in question authorizes the SFE to initiate the corresponding administrative procedures for the annulment of the registration—it should be remembered that this regulation applies to products that are already in use on the market—and, furthermore, reiterates the possibility of exercising the competences legally granted in the matter. The fact that the reform of the decree in question does not expressly cite the “competent ministries,” but rather centralizes the oversight competence, as provided in the law, does not in any way mean that other competences legally granted to other ministries, which would authorize them to adopt administrative measures in order to safeguard human health or the environment, are ignored. </span></p><p style="margin-top:0pt; margin-bottom:0pt; text-align:justify; line-height:150%; font-size:14pt"><span style="font-family:'Times New Roman'">It should be remembered that the management of the registration is the competence of the SFE, so it is logical that this authority is in charge of initiating the corresponding procedure for the annulment of the registration. In this regard, the legal authority provided for in Art. 30 of the Ley de Protección Fitosanitaria must be emphasized, which precisely entrusts the MAG with the decision to restrict or prohibit the importation, transit, redestination, manufacturing, formulation, repackaging, storage, sale, mixing, and use of chemical, biological, or related substances and application equipment for agricultural use, when justified for technical reasons and its use is considered harmful to agriculture, health, or the environment. Thus, the impugned regulatory rule is a reflection of that police power provided for the MAG. </span></p><p style="margin-top:0pt; margin-bottom:0pt; text-align:justify; line-height:150%; font-size:14pt"><span style="font-family:'Times New Roman'">However, nothing stated in the impugned article renders other legal competences ineffective, which, as was warned supra, are of public order and could, for example, urge the MAG or present the corresponding evidence so that the SFE initiates the procedure that concerns it. It should be remembered, as already warned supra, that phytosanitary protection measures have roots in our Social Rule of Law State, as they seek to protect health (Art. 21), the protection of consumer rights specifically to health and the environment (Art. 46), as well as the stimulation of agricultural production, so important for our country, in parallel with environmental protection (Art. 50). Thus, the authorities must carry out oversight jointly. </span></p><p style="margin-top:0pt; margin-bottom:0pt; text-align:justify; line-height:150%; font-size:14pt"><span style="font-family:'Times New Roman'">For example, the General Health Law contains the following competences in favor of the Ministry of Health:</span></p><p style="margin-top:0pt; margin-left:28.35pt; margin-bottom:0pt; text-align:justify"><span style="font-family:'Times New Roman'; font-style:italic">“</span><span style="font-family:'Times New Roman'; font-weight:bold; font-style:italic">Art.- 213.-</span><span style="font-family:'Times New Roman'; font-style:italic"> Any natural or legal person engaged in producing food must do so under sanitary environmental conditions and using defense or conservation techniques approved by the health authority, in order to mainly avoid the contamination of such products and their dangerousness due to the presence of toxic residues from their treatment with pesticides or other defense or conservation systems”.</span></p><p style="margin-top:0pt; margin-left:28.35pt; margin-bottom:0pt; text-align:justify"><span style="font-family:'Times New Roman'; font-weight:bold; font-style:italic; -aw-import:ignore">&nbsp;</span></p><p style="margin-top:0pt; margin-left:28.35pt; margin-bottom:0pt; text-align:justify"><span style="font-family:'Times New Roman'; font-weight:bold; font-style:italic">Art.- 244.-</span><span style="font-family:'Times New Roman'; font-style:italic"> Natural and legal persons that import, manufacture, handle, store, transport, trade, supply, or apply substances, mixtures of substances, or products called pesticides by the plant health law, shall be subject to the regulatory provisions that the Ministry dictates in common agreement with the Ministry of Agriculture for the protection of people's health in accordance with that law</span><span style="font-family:'Times New Roman'; font-style:italic">, the interested parties must register any pesticide or product intended for the control or extermination of infestations and request prior permission to operate when such substances, mixtures of substances, or products that by their nature or use</span></p><p style="margin-top:0pt; margin-left:28.35pt; margin-bottom:0pt; text-align:justify"><span style="font-family:'Times New Roman'; font-style:italic">are not included in the aforementioned law are capable of somehow producing poisonings or serious damage to the health of people or useful or harmless animals to man.</span></p><p style="margin-top:0pt; margin-left:28.35pt; margin-bottom:0pt; text-align:justify"><span style="font-family:'Times New Roman'; font-weight:bold; font-style:italic; -aw-import:ignore">&nbsp;</span></p><p style="margin-top:0pt; margin-left:28.35pt; margin-bottom:0pt; text-align:justify"><span style="font-family:'Times New Roman'; font-weight:bold; font-style:italic">Art.

245.- Natural or juridical persons engaged in pest control may operate only with a permit from the Ministry, using the substances, mixtures of substances, products, and mixtures of products authorized by the Ministry and in compliance with the applicable technical standards, in order to avoid accidents or harm to the health of the persons performing such tasks or to third parties.” (The highlighted text does not correspond to the original).

Likewise, the Organic Environmental Law provides the following:

“Article 59.- Environmental contamination. Contamination is understood as any alteration or modification of the environment that may harm human health, threaten natural resources, or affect the Nation's environment in general. The discharge and emission of contaminants shall be obligatorily subject to the technical regulations issued. The State shall adopt the measures necessary to prevent or correct environmental contamination.

Article 60.- Prevention and control of contamination. To prevent and control environmental contamination, the State, the municipalities, and other public institutions shall give priority, among others, to the establishment and operation of adequate services in fundamental areas for environmental health, such as:

• a)The supply of water for human consumption.
• b)The sanitary disposal of excreta, wastewater, and stormwater.
• c)The collection and management of waste.
• d)The control of atmospheric contamination.
• e)The control of noise contamination.
• f)The control of chemical and radioactive substances.

These services shall be provided in the manner determined by the specific laws and regulations, seeking the participation of the population and its organizations.

Article 61.- Environmental contingencies. The competent authority shall issue the preventive and corrective measures necessary when environmental contamination contingencies and others not contemplated in this law occur.” (The highlighted text does not correspond to the law).

Thus, it should be noted that the fact that the challenged decree concentrates certain registry functions in the MAG and specifically in the SFE does not disregard or nullify other types of competencies and legal authorizations provided for in favor of the Ministry of Health and MINAE regarding the safeguarding of public health and the environment. It was previously noted that the decree under examination cannot be understood as a normative body isolated from the rest of the legality and constitutionality framework, and that the specific task of updating registry information and its review does not entail nullifying the rest of the legal competencies entrusted to other ministries.

In the same vein, it is worth reiterating what was stated in the precedent transcribed supra no. 2017-06668, to the effect that to overturn a previously processed registration, the demonstration of an unacceptable risk to human health, the environment, or agriculture is indeed required, and it contemplates a power of imperium of the public administration, such as the restriction or prohibition of the use of a registration, even if a prior substantial legal situation exists in favor of the administered party, such as the registration. To that extent, a granted registration may be modified if there is evidence of an unacceptable risk, in which case the Administration – understood in a broad sense – would be enabled to exercise its powers of imperium and impose precautionary measures.

Therefore, a violation of the invoked precautionary principle is ruled out, and the grievance in question is rejected.

XIV.- Regarding Article 9 (which reforms and adds a new Article 11 to Decree No. 39995).

The claimant alleges that, continuing with the registration facilitation process and without any analysis responding to a technical and scientific basis in accordance with national and international standards, the Executive Branch intends to homologate the uses of one product with another that has similarity in the active ingredient, concentration, and formulation, when in this particular case the least that can be done is the chemical equivalence of the active ingredient, but since it refers to a formulation, the co-formulants must be analyzed, which must be declared, and the risk analysis can be performed by the ministries of health and environment, and a biological efficacy study must be presented, respecting the univocal rules of science and technique.

The Minister of MAG states that the claimant association provides nothing more than a transcription of parts of a CGR report that is absolutely decontextualized and not applicable to the specific situation. He indicates that the homologation of formulations proposed in Article 11 of the challenged decree is based on the manual of specifications of the FAO and the WHO for the development of pesticide specifications.

The challenged regulation establishes the following:

Article 9.- Article 11 is reformed and added, and the numbering of subsequent articles is corrected:

‘ARTICLE 11. Within a period of thirty-six months, counted from the entry into force of this reform, the holders of registrations of formulations with a valid registration may request from the State Phytosanitary Service the homologation of the label and pamphlet, with respect to other already registered formulations of the same type, with the same IAGT and equal concentration, in aspects related to authorized uses, pests, approved crops, doses, modes of application, application ranges, and application intervals.

The State Phytosanitary Service, through the agronomic evaluation area of the Registry Unit, shall, within a period of thirty days, carry out an assessment of each specific case and verify that the value of the physicochemical properties of the formulated product complies with the parameters established in the technical regulation in force in the country or with that of the FAO or other international reference bodies to which the already registered material complies. The resolution approving or denying the request shall be issued within a period of thirty days counted from the submission of the agronomic evaluation report. Together with the homologation request, the physical and chemical properties of the formulation, the pamphlet, and the label incorporating the requested changes must be provided.’” In the opinion of the Chamber, the deficiency in the argument is that the claimant again intends for this Court to technically dictate how to carry out the procedure for evaluating products with respect to other already registered formulations of the same type with the same IAGT and equal concentration. This responds to an entirely technical decision regarding which we lack the competence to make a determination. It appears, without a doubt, to be a discussion of legality and not of constitutionality. Note that it refers to the homologation of labels and pamphlets for products with notable similarities, so it does not seem reasonable to request, as the claimant intends without greater foundation, a chemical equivalence study. Consequently, the grievance must be dismissed, without prejudice to this being discussed more broadly in the ordinary legality channels.

XV.- CONCLUSION As a corollary of the considerations made, it is necessary to declare the filed action of unconstitutionality without merit.

Magistrates Cruz Castro and Rueda Leal issue a dissenting vote and declare the action with merit for violation of the right to a healthy and ecologically balanced environment. Magistrates Cruz Castro and Rueda Leal record separate notes.

XVI.- DOCUMENTATION PROVIDED TO THE CASE FILE. The parties are warned that if they have provided any paper document, as well as objects or evidence contained in any additional electronic, computer, magnetic, optical, telematic device or one produced by new technologies, these must be withdrawn from the office within a maximum period of thirty business days counted from the notification of this judgment. Otherwise, all material not withdrawn within this period will be destroyed, as provided in the “Regulation on Electronic Case Files before the Judicial Branch,” approved by the Full Court in Session No. 27-11 of August 22, 2011, Article XXVI and published in Judicial Bulletin No. 19 of January 26, 2012, as well as in the agreement approved by the Superior Council of the Judicial Branch, in Session No. 43-12 held on May 3, 2012, Article LXXXI.

THEREFORE:

By majority, the action of unconstitutionality is declared without merit.

Magistrates Cruz Castro and Rueda Leal issue a dissenting vote and declare the action with merit for violation of the right to a healthy and ecologically balanced environment. Magistrates Cruz Castro and Rueda Leal record separate notes.

Fernando Castillo V.

Fernando Cruz C. Paul Rueda L.

Luis Fdo. Salazar A Jorge Araya G.

Anamari Garro V. Aracelly Pacheco S.

Res. No. 2023002389 Dissenting vote of Magistrates Cruz Castro and Rueda Leal, drafted by the latter. With the customary respect, we issue a dissenting vote and declare the action with merit, for the following reasons.

As a starting point, we reiterate the criterion we expressed in judgment No. 2022-026651 at 4:30 p.m. on November 9, 2022, whose considerations are, to a large extent, applicable to the sub lite:

“1.- Regarding the referenced use of data for registration. The majority resorts to the ‘International Code of Conduct on the Distribution and Use of Pesticides. Guidelines for the Registration of Pesticides’ (April 2010) to establish the ‘acceptability of harmonized and clear registrations, the use of available information and mutual acceptance of data, the existence of information exchange mechanisms between competent authorities’ as a ‘core’ element in that technical regulation and to allege the existence of the ‘principle of non-repetition of studies.’ In that sense, it transcribes point 3 of the said code:

‘3. The principles of pesticide registration The responsible authorities, when managing their national or regional registration programs, should follow a series of important principles that are practiced internationally. The acceptance and use of these principles will ensure greater efficiency, transparency, and optimal use of resources during the registration process.

These principles include the following:

- *Complete, harmonized, and clear registration criteria and requirements;* - *Use of all available information and mutual acceptance of data;* - *Transparency and exchanges of information;* - *Evaluation made on scientific bases to determine whether precautionary measures are required;* - *Consideration of hazards;* - *Risk assessment and mitigation based on the local situation;* - *Risk/benefit analysis, taking into account the available alternatives;* - *Post-registration monitoring and evaluation;* - *Mechanisms for periodic and unscheduled reviews in order to respond to new information that may have an impact on the regulatory status;* - *Protection of the intellectual property rights of the application.* *The evaluation of the data preserved in the registration file should respect accepted and internationally agreed standards and procedures, to the extent they are available. These standards should be regularly updated to ensure their conformity with current scientific advancements.* *It is essential that all steps of the registration process be transparent, based on well-reasoned and published criteria and guidance documents, with complete information shared with the applicant on the outcome of the different steps of the registration process. The responsible authorities should ensure that the registration criteria and requirements are complete and clearly defined. The same applies to the standards for data acceptance, for data quality, for the acceptability of formulated pest control products for specific users and uses, or for degradability or accumulation criteria.* *Governments should facilitate the exchange of information between responsible authorities through national institutions, international, regional, and sub-regional organizations, as well as public sector groups. They should develop legislation and regulations to allow the exchange of information with the public on the risks and benefits of pest control products and also to facilitate public participation in the nation's pest control product management.* *The responsible authorities should, whenever possible, use data that have been placed in the public domain, and preferably those that have been previously reviewed, when considering a registration application. In this way, duplicated work and inefficient use can be minimized. The mutual acceptance of data is recommended by various regulatory authorities on topics such as efficacy and residues, among others, provided that a solid basis can be established to ensure that the data are relevant to the situation being considered.”* Thus far came the majority's citation. We consider that an adequate assessment of the case requires, at a minimum, the transcription of the two following paragraphs of that same section:

*“Furthermore, hazard assessments are generally globally applicable and are available from published sources, including the peer evaluations of the Joint FAO/WHO Meeting on Pesticide Residues (JMPR). These can be used in the evaluation of a dossier, provided that data ownership is adequately taken into account.* *Countries should fully assess the efficacy of pest control products, their behavior, final fate, hazards, and risk in relation to the various anticipated conditions of use in their country. Any registration procedure should include an assessment of the potential risks related to the pest control product use for which the product has been requested. The instructions for use, as indicated on the label, should cover these risks and prescribe measures for their proper application, storage, handling, and disposal to mitigate such risks. In doing so, the responsible authorities should also ensure that these measures can be realistically adopted by the user for whom the product has been intended. The specific requirements under national policies for Integrated Pest Management (IPM) [5] and Integrated Vector Management (IVM) [6] should also be considered.”* (The underlining is added).

Based on the foregoing, contrary to what the majority ruling concludes, we consider that the full assessment of the pest control product must be the rule. Our reading of that section is that the mutual acceptance of data is a recommendation (the standard textually states “The mutual acceptance of data is recommended…”) for the purpose of avoiding excessive procedures, such as duplicated work. However, the recognition of referenced information can never substitute for the full assessment of the pesticide.

The optional nature of the mutual acceptance of data is also derived from section 12 of the cited code, which makes such acceptance subject to the relevance and quality of the data:

*“Mutual acceptance of data. If relevant data of good quality have been generated in other countries, the responsible authority could waive the requirement for the generation of local data. This is especially important for efficacy tests, residue data, and environmental field studies, all of which are likely to require the involvement of national (public) research institutions;”* Such relevance and quality, or equivalence conditions, are conspicuously absent in the challenged decree.

The opposition of the undersigned to the use of referenced information, under the terms of the challenged rule, was shared by the then Minister of Environment and Energy, who expressed himself in this process in the following terms:

*“This section intends that those IAGTs that do not have their own information (the generics) be updated, and subsequently registered, with the submission of referenced information. This procedure is contradictory to the definition of referenced information established in Executive Decree No. 40059-MAG-MINAE-S, which indicates \"4.32. referenced information: For the application and interpretation of this regulation, it is the technical information of the reference profile, which can be used by the AC to evaluate the application for an IAGT registration by equivalence and which does not have a valid protection period\".* *In turn, the definition of reference profile indicates: \"4.49. Reference profile or source: It is the information on which the risk analysis was based and for which a regulatory decision was made and the corresponding registration was granted, and which will be used as a basis for the equivalence registration, in accordance with what is established in this regulation\". The comprehensive reading of these two definitions demonstrates that equivalence cannot be determined without having the duly evaluated and registered reference profile, upon which the referenced information is based. This procedure does not apply, according to what the cited DE 39995 contemplates, which contradicts the provisions of the CGR. The Comptroller General of the Republic (CGR), in its report FOE-AM-19/2004, pointed out the non-compliance with national and international regulations by the SFE by tolerating that registrants present information from other products (referenced information), without performing an equivalence analysis to verify whether such information is applicable to the new substance to be registered. Based on its analysis, the CGR ordered: \"Immediately suspend the practice of registering agricultural pesticides using information corresponding to another previously registered product, without having performed an equivalence analysis in accordance with the provisions of the FAO and WHO ...\". Likewise, the Constitutional Chamber in its Resolution No. 201101 6937 ordered the annulment of subparagraph b, and the reference in the penultimate paragraph to said subparagraph \"b)\" of section 7.3.2, of Article 2, of DE 33495-MAG-S-MINAE-MEIC, since said provision allowed equivalence to be based on a reference profile with incomplete data. It would be even worse to allow the updating of a registration with referenced data that have no direct relationship with the product to be updated, which would be being permitted by this regulation.”* Finally, concerning the use of existing evaluations of the same active ingredient and/or product, note that the mentioned code limits the possibilities of such practice to specific cases:

*“6.3 Use of existing evaluations of the same active ingredient and/or product* *In the event that the applicant owns the data or can fully justify the right to use the data for their registration application, there are elements of existing registrations that can be used for new applications based on the same active ingredients. However, if the data were the property of another owner and the applicant candidate cannot justify their right to use them, the responsible authority should not use the data and the evaluation of the first registrant to approve the second applicant's product.”* (The underlining is added).

In that regard, we consider that the challenged regulation undermines the protection of the environment and public health by enabling the use of referenced information, to the detriment of a full assessment of the pesticide or product.

**2.- Regarding the reduction of requirements.** Regarding this issue, the majority of the Chamber chose to consider that the action lacks adequate substantiation. In this respect, we indicate, on the one hand, that the lack of substantiation should be noticed and prevented by the Chamber in a timely manner, under the terms of Article 80 of the Constitutional Jurisdiction Law. We recognize that the lack of substantiation can lead to the action being declared without merit at the time it is reviewed on its merits. However, such a course of action should occur only when it is not clearly evident from the proceedings that the claim is appropriate, as occurs in the sub lite case.

Thus, regarding this issue, the Office of the Attorney General of the Republic stated:

*“…from the reading of Article 1 of the questioned Decree, it is possible to determine that fewer requirements are demanded for the revalidation process established therein than those required in the revalidation process established by Decree 33495, since in the latter, the confidential information dossier, the administrative dossier, as well as the acute toxicity studies defined in subparagraphs d.1.1, d.1.2, d.1.3, d.1.4, d.1.5, d.1.6, and the ecotoxicity studies defined in subparagraphs d.5.1.1, d.5.3.1, d.5.4.1, of section 7.2, were required in all cases.* *Note that for cases in which the product manufacturer has not changed, the challenged Decree only requires the application for the manufacturer update, the registration certificate issued by the authority of the country of origin, the certificate of qualitative-quantitative composition, and proof of payment of the current fee.* *For cases in which the product manufacturer has changed, although other requirements are demanded, these continue to be fewer than those required by Decree 33495. Furthermore, it is permitted that the information in the technical dossier be submitted via referenced information and it requires acute toxicity studies only when the technical grade active ingredient contains relevant impurities at levels higher than recognized international standards, or that they are in Annex III of the Rotterdam Convention, or in the Stockholm Convention, or the Montreal Protocol.* *That is to say, in the revalidation process of Decree 33495, certain technical requirements were demanded that have not been contemplated by Decree 39995, despite the fact that the recitals of the latter acknowledge that it deals with the updating of products that have not met the toxicological, ecotoxicological, and environmental fate information requirements established in international regulations and required as of the entry into force of Decree 33495.”* For her part, the Director of the Directorate of Environmental Quality Management of the Ministry of Environment and Energy stated the following:

*“DE No. 39995-MAG was issued arbitrarily and unilaterally by the MAG for the purpose of completing the dossiers of old products, including the registration of the technical grade active ingredients (IAGT) that support said formulated products (which under previous regulations did not have to be registered), as well as defining new validity periods for these old products. However, in evident non-compliance with the provisions of the CGR in report FOE-AM-19/2004, the participation of MINAE and the Ministry of Health was NOT contemplated, nor were the regulated parties requested to submit all of the studies required to carry out the environmental and health assessment, established in DE No. 33495-MAG-S-MINAE-MEIC and DE No. -40059-MAG-S-MINAE. Just as was established in DE No. 24997 and Law No. 8702, it was also not considered that the insufficient studies required in DE 39995 be analyzed by the competent authority in environmental or health matters, which results in these products continuing to be marketed without a finding that guarantees the protection of the environment and human health.”* (The underlining is added. Official Communication DIGECA-516-2018 of December 19, 2018).

**3.- Concerning the precautionary principle and the reversal of the burden of proof.** This issue was covered in our dissenting vote to judgment no. 2017-06668 of 10:50 a.m. on May 10, 2017, in the following terms:

*“Dissenting vote of Magistrates Cruz Castro and Rueda Leal, drafted by the latter. With the customary respect, we separate ourselves from the majority opinion for the following reasons.* *In their filing brief, the plaintiff explains that Article 7 of the challenged Regulation contravenes the precautionary principle and reverses the burden of proof in environmental matters. They reach this conclusion because the provision in question obligates the competent ministries to “…demonstrate an unacceptable risk to human health, the environment, or agriculture…” so that the Phytosanitary Service may restrict or prohibit the use of a registration.* *In the judgment, the majority of this Court considered that the claim was not appropriate because the questioned rule actually protected the environment. In that sense, the resolution argues that the moment for application of the precautionary principle is during the processing of a registration application. Once the registration is granted, it will be necessary to demonstrate the unacceptable risk indicated by the rule.* *As a starting point, it is necessary to recall what this Chamber has stipulated regarding the precautionary principle in environmental matters:* *“III.- The prevention of environmental risk. Establishing this obligation of the State at the constitutional level, it is important to appreciate how, at the level of international human rights protection instruments, specific obligations that must be respected are also established. In environmental matters, the duty of prevention that must exist in this area has been defined; the Rio Declaration, adopted at the United Nations Conference on Environment and Development, stipulates that:* *\"Principle 15.- In order to protect the environment, the precautionary approach shall be widely applied by States according to their capabilities. Where there are threats of serious or irreversible damage, lack of full scientific certainty shall not be used as a reason for postponing cost-effective measures to prevent environmental degradation\".* *Prevention seeks to anticipate negative effects and ensure the protection, conservation, and adequate management of resources. Consequently, the guiding principle of prevention is based on the need to take and assume all precautionary measures to avoid or contain the possible impact on the environment or people's health. In this way, in the event that there is a risk of serious or irreversible damage—or doubt in this regard—a precautionary measure must be adopted and even the activity in question postponed. The foregoing is due to the fact that in environmental matters, a posteriori coercion is ineffective, as once the damage has occurred, the biological and socially harmful consequences may be irreparable; repression may have moral significance but will hardly compensate for the damages caused to the environment.* *As the cited international instrument, as well as Article fifty of the Constitution, points out, it is the State that is called upon to carry out this prevention work, and this Chamber has so recognized by stating, through judgment number 2001-6503, of July six, two thousand one, that:* *“The third paragraph of Constitutional provision 50 clearly states that the State must guarantee, defend, and preserve the right of every person to a healthy and ecologically balanced environment; which implies affirming that public entities are not only obligated to enforce—to individuals and other public entities—environmental legislation, but also, above all, that they must adjust their actions to the dictates of those protective regulatory bodies.* State institutions are the first ones called upon to comply with environmental protection legislation, with no justification whatsoever existing to exempt them from fulfilling environmental requirements such as, by way of example, the environmental impact assessment (estudio de impacto ambiental) required by the Ley Orgánica del Ambiente for activities undertaken by public entities that, by their nature, may alter or destroy the environment." (Sentencia 2010-11941 of 11:21 a.m. on July 9, 2010) As can be seen from the transcription, the prevalence of the precautionary principle lies in the need to avoid serious and irreparable damage to the environment, requiring that measures be adopted to anticipate such damage. That is, given the possibility that an irreversible or serious danger may materialize, the State’s duty to act arises, requiring for this only the existence of a reasonable doubt of risk to the environment.

Now then, contrary to what the majority defends, the precautionary principle is not limited to one stage of the administrative proceeding, but rather constitutes one of the principles that must guide administrative action at all times.

We consider that the interpretation made by the Chamber could mean the creation of a presumption in favor of registration and against the environment and human health. In this way, the State would be burdened with proving the existence of the aforementioned risk in order to overcome such a presumption. But even more, it is not enough to merely demonstrate the risk; the State must also prove, according to the majority, that said risk is unacceptable, which makes the possibility of acting in favor of the environment and human health even more difficult.

These requirements could be unreasonable and disproportionate, since months or years may elapse between the moment when the reasonable doubt arises and the moment when the existence of a risk of an unacceptable degree can be demonstrated. This period of time would allow the risk to materialize and cause irreversible or serious injury to the environment and human health. Thus, there could be a contradiction between the de lege lata situation and the aims of the precautionary principle, which clearly justifies that the action be processed.

The claimant may also be right in criticizing the reversal of the burden of proof. In this case, the registration holder has all the technical information related to the product and, moreover, is the interested party in maintaining its legal use in the country, which makes it reasonable to impose on it the burden of proving its harmlessness to the environment and human health.

We consider that all these issues must be analyzed in greater detail by the full Chamber, granting an audience to the Procuraduría General de la República and the competent bodies.

Furthermore, in view of the current environmental problems and the international consensus regarding the imminence of environmental problems that threaten the entire human race (such as climate change, recognized in the Paris Agreement by 193 States), the undersigned are surprised that the majority of this Chamber advocates the non-application of the precautionary principle and, rather, defends the imposition of qualified requirements on the Administration when it seeks to safeguard the environment and human health.

By virtue of the arguments set forth, we dissent from the opinion and order that the action be processed." **4.- Regarding citizen participation (participación ciudadana).** In judgment no. 2021-25386 of 1:10 p.m. on November 10, 2021, we referred to citizen participation in the following terms:

"As recorded in the dissenting vote to judgment no. 2017-1163 of 9:40 a.m. on January 27, 2017, we consider that from Article 9 of the Political Constitution it is extracted that citizen participation, beyond a general principle, has been instituted as a true fundamental right in light of the conventional framework that accompanies and integrates our regime of fundamental rights.

Precisely, in judgment no. 2013-017305 of 11:32 a.m. on December 20, 2013, the Constitutional Chamber considers that the right to citizen participation in decision-making has become one of the fundamental pillars upon which the democratic system rests. In our country, the constitutional legislator enshrined this right in Article 9 of the Political Constitution by providing that the Government of the Republic be popular, representative, participatory, alternative, and responsible (emphasis not in the original), according to the reform fostered by Law no. 8364 of July 1, 2003, published in La Gaceta no. 146 of July 31, 2003. This mandate of the Fundamental Law, particularly the quality of “participatory,” has guided subsequent constitutional and infra-constitutional normative development. Thus, a series of mechanisms has been established that seek to ensure that the right to participatory government can be applied efficiently and effectively, so that it does not remain merely a paper right; examples of the foregoing are the referendum for the approval or repeal of laws and partial reforms to the Constitution, or the popular initiative in the formation of laws (see, among others, judgment number 2005-05649 of 2:39 p.m. on May 11, 2005).

The right to participatory government not only embodies recognition at the highest legal-positive level for the function of political control by the inhabitants of the Republic, but also signifies a revaluation of their role in the processes of formulation, application, and control of public policy. By the will of the constituent legislator, which this Chamber should not and cannot disregard, the right to participatory government stands as a fundamental pillar of our democratic regime (a matter erroneously disregarded by the minority vote, which lowers citizen participation from the category of a right to a general principle in clear contradiction to the jurisprudential line of this Chamber, as demonstrated below), which is consistent with a political system based on tolerance, pluralism, and respect for freedom.

As indicated supra, this categorization of participatory government or citizen participation as a right is explained through the conventional backing contained in various international human rights instruments.

For example, Article 21 of the 1948 Universal Declaration of Human Rights provides that “everyone has the right to take part in the government of his country, directly or through freely chosen representatives” (emphasis not in the original).

Consistent with the foregoing, Article 25 of the International Covenant on Civil and Political Rights expressly recognizes the right of citizens: “(…) to take part in the conduct of public affairs, directly or through freely chosen representatives.” In the same vein, the Inter-American Democratic Charter indicates in its Article 5 that: “Representative democracy is strengthened and deepened by the permanent, ethical, and responsible participation of citizens within a legal framework consistent with the respective constitutional order.” More forcefully, Article 6 of this Charter establishes that: “The participation of citizens in decisions relating to their own development is a right and a responsibility. It is also a necessary condition for the full and effective exercise of democracy. Promoting and fostering diverse forms of participation strengthens democracy.” (Emphasis not in the original).

The United Nations Human Rights Council also recognized citizen participation as fundamental for environmental protection:

“Recognizing also that the exercise of human rights, including the freedom to seek, receive and impart information and to participate effectively in the conduct of government and public affairs and the right to an effective remedy, is fundamental for the protection of a clean, healthy, risk-free, and sustainable environment,” (Human Rights Council, 46th session, A/HRC/RES/46/7 of March 23, 2021).

It is also important to highlight that, recently, the United Nations Human Rights Council, in resolution A/HRC/RES/48/13 of October 8, 2021, has come to grant the status of a human right to effective participation in environmental matters. In this regard, it stated:

“Recognizing that the exercise of human rights, including the rights to seek, receive and impart information and to participate effectively in the conduct of government and public affairs and in the adoption of decisions relating to the environment, as well as the right to an effective remedy, is fundamental for the protection of a clean, healthy and sustainable environment.” (Emphasis not in the original).

For its part, in Advisory Opinion OC-23/17 of November 15, 2017, the Inter-American Court of Human Rights highlighted that:

“226. Public participation represents one of the fundamental pillars of instrumental or procedural rights, since it is through participation that individuals exercise democratic control over State management and can thus question, investigate, and consider the fulfillment of public functions. In that sense, participation allows individuals to be part of the decision-making process and to have their opinions heard. In particular, public participation facilitates that communities demand accountability from public authorities for decision-making and, at the same time, improves the efficiency and credibility of government processes. As has been mentioned on previous occasions, public participation requires the application of the principles of publicity and transparency and, above all, must be supported by access to information that allows social control through effective and responsible participation” (emphasis added).

A view that had also been adopted in the judgment of September 19, 2006, concerning the case “Claude Reyes et al. vs. Chile,” which provided:

“86. In this sense, the State’s actions must be governed by the principles of publicity and transparency in public management, which makes it possible for the persons under its jurisdiction to exercise democratic control over State management, so that they can question, investigate, and consider whether public functions are being adequately fulfilled. Access to information under the control of the State, which is of public interest, can permit participation in public management, through the social control that can be exercised with such access. 87. Democratic control, by society through public opinion, fosters the transparency of State activities and promotes the responsibility of officials regarding their public management. Therefore, for individuals to exercise democratic control, it is essential that the State guarantee access to information of public interest under its control. By allowing the exercise of that democratic control, greater participation of individuals in the interests of society is fostered.” (Emphasis added).

Thus, this conventional recognition of citizen participation hermeneutically affects its legal nature, since from a constitutional principle it transforms it into a true collective fundamental right.

In this way, citizen participation represents an essential aspect of the democratic and republican model of this century, in which citizen control, transparency, and accountability stand out as expressive elements of this type of political regime, which in turn confers much greater legitimacy on political decision-making, a key issue when it comes to governability. Thus, within the framework of this type of regime —that is, with active and full citizen participation—, participatory government impacts with greater intensity, favoring decision-making through more open and transparent means.

Precisely, one of the mechanisms designed to comply with the provisions of Article 9 of the Constitution is the public hearing (audiencia pública), through which interested persons can assert their rights or express their opinion, actively participating in matters of national or local relevance, and bringing to the Administration's attention all those anomalies or disagreements regarding a project to be developed.

Thus, the public hearing is a typical instrument of a republican democracy, through which citizen participation in the process of public decision-making is fostered. Due to its significance, the hearing must be conducted in such a way as to guarantee the greatest possible participation of the persons who may be affected; hence, any action or omission that hinders the foregoing constitutes an open violation of the constitutional right to citizen participation (see, among others, judgment number 2009-018223 of 12:34 p.m. on November 27, 2009).

Regarding the participatory nature of the public hearing, as indicated, Article 9 of the Political Constitution itself requires it, since the classification “participatory” provided therein implies, among other aspects, that the Government must be an articulator of what is defined by popular deliberation, when this is obligatory, while at the same time, in the formulation of public policy, within the possibilities that the current positive legal framework raises, it is obligated to hear the opinion of affected individuals or groups, whether this is binding or not.

In other words, in the current republican democracy, citizens enjoy, by constitutional mandate, no longer only the right to vote to exercise their right to participatory government, but also a number of instruments of a diverse nature to contribute to governmental decision-making and political control, which fosters their ability to exert direct influence on major public decisions.

Within this context, it is of interest to highlight that this Court, in judgment no. 2018004117 of 9:15 a.m. on March 13, 2018, elaborated on public consultation (consulta pública) in environmental matters, emphasizing that this mechanism is a pillar in decision-making related to the environment. Likewise, as a form of soft law, it resorted to a particularly relevant instrument concerning access to environmental information and citizen participation: the “Convention on Access to Information, Public Participation in Decision-making and Access to Justice in Environmental Matters,” better known as the “Aarhus Convention.” In this regard, the aforementioned ruling stated:

“The Aarhus Convention, for its part, in Article 6.2.3.4 provides:

“2. When a decision-making process regarding the environment is initiated, the public concerned shall be informed, as appropriate, effectively and in a timely manner, by means of public communication or individually, as the case may be, at the beginning of the process. The information shall refer in particular to:

• a)The proposed activity, including the corresponding application on which a decision will be made; b) The nature of the possible decisions or the draft decision; c) The public authority responsible for making the decision; d) The procedure foreseen, in particular, the cases in which this information may be provided:
• i)The date on which the procedure will begin; ii) The opportunities offered to the public to participate therein; iii) The date and place of any foreseen public hearing; iv) The public authority to which inquiries can be made to obtain relevant information and where such information has been deposited for the public to examine; v) The public authority or any other competent public body to which comments or questions may be addressed and the timeframe foreseen for communicating comments or questions; vi) The indication of the environmental information relating to the proposed activity that is available; and e) The fact that the activity is subject to a national or transboundary environmental impact assessment procedure.

3. For the different phases of the public participation procedure, reasonable timeframes shall be provided that allow sufficient time to inform the public in accordance with paragraph 2 above and for the public to prepare and participate effectively in the work throughout the entire environmental decision-making process.

4. Each Party shall take measures so that public participation begins at the start of the procedure, that is, when all options and solutions are still possible and when the public can exert real influence.” In accordance with the foregoing, consultation must be fostered transparently and with the greatest possible information. This generates better management of natural resources, contributes to transparency, and to the adequate handling of public funds. Let us remember that the environmental issue is a matter for all members of society, not just the government, and therefore it is also the responsibility of each citizen to ensure environmental conservation and strive for sustainable development. This is why it must comprehensively encompass the different sectors of the population (…)”. (Emphasis added).

In addition, in the aforementioned ruling, the Chamber stressed that the citizen hearing (audiencia ciudadana), as a manifestation of the democratic principle, must not become a simple formality that simply has to be scheduled, though neither should it be instrumentalized as a mere obstacle to the issuance of an administrative decision.

Related to the foregoing, this Chamber has repeatedly indicated that the Constitution is characterized by its supremacy and its direct and immediate efficacy, by virtue of which the rights and guarantees it confers are directly enforceable and binding on all Public Powers.

Thus, in Judgment No. 1992-3194 of 4:00 p.m. on October 27, 1992, it was specified:

"(...) The Political Constitution, in its unanimous contemporary conception, is not only 'supreme' as a criterion of validity for itself and for the rest of the legal system, but also a set of legally binding fundamental norms and principles, therefore, enforceable by themselves, against all public authorities, and against private individuals themselves, without the need for other norms or acts to develop them or make them applicable, except in qualified cases of exception, where without them its application is impossible—with the consequence that both administrative and jurisdictional authorities have the attribution-duty to directly apply the Law of the Constitution in its full sense, even in the absence of a lower-ranking norm or by disapplying those that oppose it."

For its part, in Judgment No. 1995-1185 of 2:33 p.m. on March 2, 1995, this Court confirmed:

"If the Political Constitution has a supreme normative character, it must effectively shape and condition the validity and effectiveness of every inferior or subordinate norm, and serves as a parameter to legitimize or not the actions of any public authority and even of private subjects... The principle of supremacy of the Constitution, in the Costa Rican case, is not only expressly enshrined in Article 10, but is also very clearly complemented with respect to the body responsible for maintaining or preserving it, according to what we will analyze below. What we have expressed so far revolves around the fact that the Constitution has direct efficacy and binds without the need for intermediation by any other norm. And, it is for this reason, that every authority, in general, has the capacity and power to apply, develop, and expand the fundamental rights contained in the Political Constitution. If this were not so, all the argumentation about the hierarchy of constitutional norms, principles, and values would collapse, converted into an unsustainable fantasy. It would be mere science fiction, a non-existent entity, in which two legal worlds simultaneously exist, located on different planes and without communication between them." In conclusion, citizen participation constitutes a constitutional and conventional right, which stands as a quality of the republican democratic system. In this regard, the rights enshrined in the Fundamental Law, to varying degrees depending on whether their content is more or less programmatic, have direct efficacy and bind without the need for any other norm. Even their effectiveness through infra-constitutional normative development and its application is not exempt from jurisdictional constitutional control, when regulations, actions, or omissions are noted that represent an injury to the hard core (Kernbereich) of that constitutional good." In the sub lite, we consider that the challenged decree injures the right to citizen participation in matters of utmost importance for the population, such as the environment and public health. The relevance of citizen participation in this matter is recognized in the aforementioned "International Code of Conduct on the Distribution and Use of Pesticides. Guidelines for the Registration of Pesticides," whose point 3 (The principles of pesticide registration) states:

"Governments should facilitate the exchange of information between responsible authorities through national institutions, international, regional, and sub-regional organizations, as well as public sector groups. They should develop legislation and regulations to allow the exchange of information with the public on the risks and benefits of pesticides and also to facilitate public participation in the management of the country's pesticides." (Emphasis added).

Citizen participation is also included in its point 10 (Coordination and collaboration):

"10.1.3 Regulated community There should be periodic dialogues between the responsible authority and the regulated community, including the pesticide industry, pesticide vendors, professional pest control operators, pesticide advertising agencies, and the general public, so that they receive feedback and suggestions on the implementation and application of pesticide registration in the country. The responsible authority should encourage the pesticide industry to develop low-risk pesticide products as well as product stewardship activities.

10.1.4 Civil society The responsible authority may have a frequent dialogue with representatives of civil society to address issues related to pesticide registration in the country. Civil society groups can in particular be important for providing feedback on the use of pesticides, and on the real and potential problems that may arise." (Emphasis added)." Additionally, with respect to the specific case, we establish the following defects that warrant declaring the decree unconstitutional.

Regarding the reduction of requirements for the approval of the validation (valida), we determine that Article 1 does not require acute toxicity and ecotoxicity studies, as Decree 33495 did. Furthermore, Article 1.1 eliminated the request for the manufacturer's update, the registration certificate issued by the authority of the country of origin, and the endorsement of a chemist for the qualitative-quantitative composition certificate. Article 1.2 eliminated the registration certificate issued by the authority of the country of origin.

Likewise, regarding the use of referenced information, we adopt the observations of the Office of the Attorney General (Procuraduría General de la República):

"…although the Office of the Attorney General is not a technical body in this matter, it can be indicated that even though the challenged Decree modifies Articles 1.2.b and 6 of Decree 39995 that allowed registering products using referenced information, it maintains that possibility, since Article 1.2.c allows the use of international specifications to certify that the technical material intended to be updated does not have relevant impurities, indicating in the fifth whereas clause (considerando quinto) that international specifications and standards are a technical and scientific reference for determining that technical grade active ingredients do not contain relevant impurities at levels higher than international standards or specifications, and that only those relevant impurities are those that have toxicological or ecotoxicological relevance that can cause an impact on health or the environment.

In that same sense, Article 3° provides that formulated pesticides that do not have an associated technical grade active ingredient registration will be granted that registration directly when the manufacturer of that active ingredient has been updated; Article 6° provides that upon meeting the requirements, the registration will be granted for ten years and that, during that period, the SFE will verify that the already approved registrations of technical grade active ingredients have chemical equivalence with the reference profile of that active ingredient and that, in the absence of that profile, it must be verified that they do not contain relevant impurities; and Article 11 endorses the homologation of labels and leaflets with those of other already registered products that have the same active ingredient and equal concentration, without contemplating the effects that the other components of the product or the form or method of manufacture could have.

The challenged norm does not establish how the information will be verifiable, how to determine which international specification may be used, how to determine the equivalence of products, nor whether the reference profile to be used must be a registration that has complete information, and therefore, that covers studies of acute toxicity, ecotoxicity, chronic toxicology, ecotoxicological studies, and other studies on the abiotic environment as required by Article 5° of the Law for the Import and Quality Control of Agrochemicals and the Manual on the Development and Use of FAO and WHO Specifications for Pesticides.

Hence, as indicated in the prior report, by not precisely establishing the rules to which the competent authority must adhere to verify the information, it is possible that the updating of registrations with referenced information that does not meet the indicated requirements may be permitted, and, therefore, this would imply the updating of product registrations without a prior evaluation regarding the environmental and health risks of their application." By virtue of the foregoing, we determine that the challenged decree contravenes the constitutionality block (bloque de constitucionalidad) and injures the right to a healthy and ecologically balanced environment. Therefore, we dissent (salvamos el voto) and declare the action granted.

**Fernando Cruz C.** **Paul Rueda L.** **Exp. 19-005920-0007-CO** **Res. No. 2023002389** **Note of Magistrate Rueda Leal.** As I have expressed in other cases, I consider that a quality of diffuse interest (interés difuso) consists precisely in that its impact is general—that is, it affects an entire population or broad sectors thereof—within a context where it is not necessary that the injured subjects know each other (they could even lack any nexus or legal relationships among them), but the presence of the same situation of damage or danger to a constitutional good is required, which, equally and without any need for individualization, encompasses and gathers together an entire society in the abstract. Its defense aims to satisfy a need of society as such, thus, it transcends that of a human being considered individually or collectively. In Judgment No. 2019-17397 of 12:54 p.m. on September 11, 2019, this Court reiterated the following:

"(...) Secondly, the possibility of appearing in defense of 'diffuse interests' is foreseen; this concept, whose content has been gradually outlined by this Chamber, could be summarized in the terms used in this court's judgment number 3750-93, of three o'clock in the afternoon on July thirtieth, nineteen ninety-three) '... Diffuse interests, although difficult to define and more difficult to identify, cannot be in our law—as this Chamber has already said—merely collective interests; nor so diffuse that their ownership is confused with that of the national community as a whole, nor so concrete that against them, determined persons, or personalized groups, are identified or easily identifiable, whose standing would derive, not from diffuse interests, but from corporate interests that concern a community as a whole. It is then a matter of individual interests, but at the same time, diluted in more or less extensive and amorphous groups of people who share an interest and, therefore, receive a current or potential harm, more or less equal for all, which is why it is rightly said that they are equal interests of the groups that find themselves in certain circumstances and, at the same time, of each one of them. That is, diffuse interests partake of a dual nature, since they are at once collective—for being common to a generality—and individual, so they can be claimed in that capacity'."

"In summary, diffuse interests are those whose ownership belongs to groups of people not formally organized, but united based on a certain social need, a physical characteristic, their ethnic origin, a certain personal or ideological orientation, the consumption of a certain product, etc. The interest, in these cases, is blurred, diluted (diffuse) among an unidentified plurality of subjects. In these cases, of course, the challenge that a member of one of these sectors could make, protected by paragraph 2 of Article 75, must necessarily refer to provisions that affect them as such. This Chamber has listed various rights that it has qualified as 'diffuse,' such as the environment, cultural heritage, the defense of the country's territorial integrity and the good management of public spending, among others. In this regard, two clarifications must be made: on the one hand, the referred goods transcend the sphere traditionally recognized for diffuse interests, since they refer in principle to aspects that affect the national community and not particular groups thereof; environmental damage does not affect only the residents of a region or the consumers of a product, but injures or puts at grave risk the natural heritage of the entire country and even of Humanity; likewise, the defense of the good management made of the public funds authorized in the Republic's Budget is an interest of all the inhabitants of Costa Rica, not just of any group of them. On the other hand, the enumeration made by the Constitutional Chamber is no more than a simple description inherent in its obligation—as a jurisdictional body—to limit itself to hearing the cases submitted to it, without it being possible in any way to come to understand that only those that the Chamber has expressly recognized as such can be considered diffuse rights; the foregoing would imply an undesirable shift in the scope of the Rule of Law, and of its correlative 'State of rights,' which—as in the case of the Costa Rican model—starts from the premise that what must be express are the limits to freedoms, since these underlie the human condition itself and do not therefore require official recognition. Finally, when paragraph 2 of Article 75 of the Law of Constitutional Jurisdiction speaks of interests 'that concern the community as a whole,' it refers to the legal goods explained in the preceding lines, that is, those whose ownership rests in the very holders of sovereignty, in each of the inhabitants of the Republic." "It is therefore not a matter of any person being able to appear before the Constitutional Chamber in protection of any interests whatsoever (actio popularis), but rather that any individual can act in defense of those goods that affect the entire national community, without any attempt at an exhaustive enumeration being valid in this field either" (see Judgment No. 2007- 01145)." In accordance with what has been stated and sustained by this Court in its jurisprudence, it is therefore a matter of individual interests, but at the same time, diluted in more or less extensive and amorphous groups of people who share an interest and, therefore, receive a harm, current or potential, more or less equal for all, which is why it is rightly said that they are equal interests of the groups that find themselves in certain circumstances and, at the same time, of each one of them. It is precisely for this reason that, from Judgment No. 2021-2185 of 12:51 p.m. on February 3, 2021, I consider, unlike the Majority of this Court, that some of these interests may be embodied in a specific particular case, without thereby losing their condition as a diffuse interest, as occurs with the protection of the environment, whose impact affects one person and everyone in general; and such impact can be individualized in a particular situation, such as, for example, the construction of a factory in a specific neighboring sector, without the respective environmental studies, whose negative effects impact the planet's ozone layer. Undoubtedly, the result of a claim or process that a neighbor may bring against that factory will not only affect their own interests but also the rest of the community. For this reason, it constitutes a diffuse interest; and, nevertheless, it is also the object of a specific, individualized situation. Now, this does not mean, by any means, that in every situation invoked the existence of a diffuse interest can be alleged, even if this can be the object of a particular situation. Let us remember that for an interest to be considered 'diffuse,' it must not only affect a community, but must also be blurred, spread out in that community. If it does not produce such effect, it cannot be considered a diffuse interest. In this case, the diffuse interest alleged by the claimants is the protection of the environment. For this reason and based on the clarifications just made, I hear the case on the merits.

**Paul Rueda L.** **Exp: 19-005920-0007-CO** **Res. N° 2023-002389** **NOTE OF MAGISTRATE CRUZ CASTRO.-** The importance of protecting the right to the environment, health, and food safety, and in application of the constitutional environmental principles of progressivity and non-regression, the precautionary principle, the preventive principle, the principle of in dubio pro natura, and the principle of objectivization in the matter of pesticide regulation.

As I have considered in other cases where the issue of pesticides has come for discussion before this Chamber, it is relevant to start from the jurisprudential antecedent, Judgment No. 2011-016937 of 2:36 p.m. on December 7, 2011: (https://nexuspj.poder-judicial.go.cr/document/sen-1-0007-532977). Here the Chamber outlined the constitutional framework under which a regulation for the registration, use, and control of pesticides must be analyzed, when in the action of unconstitutionality filed against Executive Decree No. 33495-MAG-S-MINAE-MEIC of October 31, 2006, the following was indicated:

**VI.- FOOD SAFETY, TRACEABILITY OR TRACKING, AND THE APPLICATION OF THE PRECAUTIONARY PRINCIPLE.** This Chamber, in Resolution 13924-2011 of 5:59 p.m. on May 10, referred to the issue of agri-food safety: "*The right to food has been incorporated in most legal systems as a human right, now recognized in International Treaties and even elevated in many countries to constitutional status. Agri-food law must be understood as the set of special norms, systematically ordered, that regulate the agri-food product and its productive chain in all its phases, from production to consumption, controlling the stages of the agri-food enterprise and its productive activity for the purpose of guaranteeing the dietary consumption of healthy and safe products, in order to protect the health of persons, animals, and plants, or else, seek the food supply for the population. From the foregoing definition derives the interpreter's need to contribute to the formulation and systematization of these special norms, in order to establish, within the framework of a general theory of agri-food law, what is the object, the subjects, the possible normative sources, the activities, and general principles that should guide the discipline.*" The quality and health requirements in turn impose requirements of <span style="font-style:italic">traceability (trazabilidad o rastreabilidad)</span><span style="font-style:italic"> </span><span style="font-style:italic">of the product throughout the entire agri-food chain. In the various spheres of activity, the global "farm to table" approach is embraced, which characterizes this policy and consolidates the indivisible character of the food chain, and focuses on the decisive role played by the National Animal Health Service (Servicio Nacional de Salud Animal). The conditions of any traceability system are: 1. At all stages of the chain, food safety must be ensured; 2. Agri-food businesses must be able to identify any subject in the chain; 3. Businesses must establish the necessary procedures and methods for this; 4. Systems and procedures must be implemented to be able to identify the products delivered; 5. Marketed foods must be identified for the purpose of determining their origin. The need to find a balance between protective mechanisms for food safety for preventive purposes—the precautionary principle—and the guarantee of the free movement of agri-food products that comply with international scientific standards is evident. The foregoing produces as a requirement the "monitoring" of agricultural and food products, that is, traceability throughout the entire chain, in order to determine the potential liability that may correspond to the agricultural producer or the company that transforms the products into food, even at each phase of the chain</span><span>." Furthermore, the Phytosanitary Protection Law (Ley de Protección Fitosanitaria), No. 7664 of April 8, 1997, also incorporates standards to avoid and prevent the introduction and spread of pests that threaten food security and the economic activity sustained by agricultural production, preventing such measures from unnecessarily constituting an obstacle to free trade (Article 2). For that reason, control mechanisms are established for the establishment, registration, and inscription of inputs for agricultural use, even establishing standards of agro-environmental liability (responsabilidad agroambiental) when damages and losses are caused to agriculture, the environment, and human and animal health (Chapter IV). Within this context, the use of agrochemicals (agroquímicos) acquires particular relevance for the exercise of agricultural productive activity, a subject on which there are multiple regulations at the national, regional, and international normative level (Article 47). Because precisely its regulation is fundamental, within the framework of the agricultural competitiveness of producers on a global scale. In this context, national laws are enacted that introduce, or at least attempt to do so, integrated agri-food and agro-environmental control systems, to guarantee the safety of people, the environment, and plants and animals, and even to prevent excessive contamination of water resources. Without a doubt, the rational use of synthetic pesticides (plaguicidas sintéticos) for agricultural use promotes the competitiveness of the agricultural sector, and that is why the regulation is inspired by the creation of a balanced and modern registration system. It is a clear example of the effort to give completeness and organicity to a large number of scattered norms in the legal system, to respond to the demands of specialized international regulations, emanating both from the World Trade Organization and from the Specialized Agencies, the FAO, and the WHO, closely linked with the Codex Alimentarius, and with the International Environmental Conventions. That is why the Decree is issued jointly by the Presidency, and the Ministers of Agriculture, Health, Environment and Energy, and that of Economy, Industry and Commerce. It is evident that the phenomenon links the entire agricultural and livestock production process, and even the entire previous facet of production, registration, control, and oversight of pesticides used in the agro-productive chain.</span></p><p style="margin-top:0pt; margin-left:64.35pt; margin-bottom:0pt; text-indent:28.35pt; text-align:justify; background-color:#ffffff"><span style="font-weight:bold">VII.- ON THE REDUCTION OF RISKS TO HEALTH AND THE ENVIRONMENT, PURSUANT TO THE PROVISIONS OF ARTICLE 5 OF THE INTERNATIONAL CODE OF CONDUCT ON THE DISTRIBUTION AND USE OF PESTICIDES.</span><span> </span><span>It is of interest to refer to the provisions of the cited International Code of Conduct on the Distribution and Use of Pesticides, which was adopted for the first time in 1985, by the Twenty-fifth Session of the Conference of the Food and Agriculture Organization of the United Nations (FAO). As explained in the preface to the revised version (adopted by the 123rd Session of the FAO Council, November 2002), said code of conduct was adopted and has been revised with the purpose of achieving greater food security and, at the same time, protecting human health and the environment. For such purposes, standards of conduct are established that are to serve as a framework and point of reference for the adequate and rational use of pesticides, which focus on risk reduction, the protection of human and environmental health, and the support for the development of sustainable agriculture through the effective use of pesticides [source: (Source:</span><span> </span><a href="http://www.fao.org/agriculture/crops/core-themes/theme/pests/pm/code/en/" style="text-decoration:none"><span style="text-decoration:underline; color:#0000ff">http://www.fao.org/agriculture/crops/core-themes/theme/pests/pm/code/en/</span></a><span>(05/08/11)] In this context, said code of conduct establishes, in its Article 5, the following obligations for governments and the pesticide industry:</span></p><p style="margin-top:0pt; margin-left:64.35pt; margin-bottom:0pt; text-indent:28.35pt; text-align:justify; background-color:#ffffff"><span style="font-weight:bold; font-style:italic">“Article 5. Reduction of risks to health and the environment</span></p><p style="margin-top:0pt; margin-left:64.35pt; margin-bottom:0pt; text-indent:28.35pt; text-align:justify; background-color:#ffffff"><span style="font-weight:bold; font-style:italic">5.1</span><span style="font-style:italic"> </span><span style="font-style:italic">Governments should:</span></p><p style="margin-top:0pt; margin-left:64.35pt; margin-bottom:0pt; text-align:justify; background-color:#ffffff"><span style="font-weight:bold; font-style:italic">5.1.1</span><span style="font-weight:bold; font-style:italic"> </span><span style="font-style:italic">implement a pesticide registration and control system as indicated in Article 6;</span></p><p style="margin-top:0pt; margin-left:64.35pt; margin-bottom:0pt; text-align:justify; background-color:#ffffff"><span style="font-weight:bold; font-style:italic">5.1.2</span><span style="font-style:italic"> </span><span style="font-style:italic">periodically review pesticides marketed in their own country, their acceptable uses and their availability to each sector of the public, and carry out special reviews when scientific evidence so advises;</span></p><p style="margin-top:0pt; margin-left:64.35pt; margin-bottom:0pt; text-align:justify; background-color:#ffffff"><span style="font-weight:bold; font-style:italic">5.1.3</span><span style="font-style:italic"> </span><span style="font-style:italic">carry out a health surveillance program for persons occupationally exposed to pesticides, and investigate and document poisoning cases;</span></p><p style="margin-top:0pt; margin-left:64.35pt; margin-bottom:0pt; text-align:justify; background-color:#ffffff"><span style="font-weight:bold; font-style:italic">5.1.4</span><span style="font-style:italic"> </span><span style="font-style:italic">provide guidance and instructions to health personnel, physicians and hospital staff for the treatment of suspected cases of pesticide poisoning (25);</span></p><p style="margin-top:0pt; margin-left:64.35pt; margin-bottom:0pt; text-align:justify; background-color:#ffffff"><span style="font-weight:bold; font-style:italic">5.1.5</span><span style="font-style:italic"> </span><span style="font-style:italic">establish national or regional information and control centers for poisoning cases at strategic locations, so that they can provide immediate guidance on first aid and medical treatment, and be accessible at all times (25);</span></p><p style="margin-top:0pt; margin-left:64.35pt; margin-bottom:0pt; text-align:justify; background-color:#ffffff"><span style="font-weight:bold; font-style:italic">5.1.6</span><span style="font-style:italic"> </span><span style="font-style:italic">utilize all possible means to collect reliable data and maintain statistics on the health aspects of pesticides and pesticide poisoning incidents, in order to establish the harmonized WHO system for the identification and registration of such data (25). They should have properly trained personnel and sufficient resources to ensure that accurate information is collected;</span></p><p style="margin-top:0pt; margin-left:64.35pt; margin-bottom:0pt; text-align:justify; background-color:#ffffff"><span style="font-weight:bold; font-style:italic">5.1.7</span><span style="font-style:italic"> </span><span style="font-style:italic">provide extension and advisory services, as well as farmers' organizations, with adequate information on practical IPM strategies and methods and on the range of pesticide products available for use;</span></p><p style="margin-top:0pt; margin-left:64.35pt; margin-bottom:0pt; text-align:justify; background-color:#ffffff"><span style="font-weight:bold; font-style:italic">5.1.8</span><span style="font-style:italic"> </span><span style="font-style:italic">ensure, with the cooperation of the pesticide industry, that, in cases where pesticides are distributed through the same channels as food, clothing, medicines and other products for consumption or topical application, such pesticides are physically separated from other goods to prevent contamination and/or mistaken identity. In addition, where appropriate, they should be clearly marked as hazardous materials. Every effort should be made to disseminate information on the dangers of storing food and pesticides together (26);</span></p><p style="margin-top:0pt; margin-left:64.35pt; margin-bottom:0pt; text-align:justify; background-color:#ffffff"><span style="font-weight:bold; font-style:italic">5.1.9</span><span style="font-style:italic"> </span><span style="font-style:italic">utilize all possible means to collect reliable data, maintain statistics on environmental contamination and report specific incidents related to pesticides;</span></p><p style="margin-top:0pt; margin-left:64.35pt; margin-bottom:0pt; text-align:justify; background-color:#ffffff"><span style="font-weight:bold; font-style:italic">5.1.10</span><span style="font-weight:bold; font-style:italic"> </span><span style="font-style:italic">implement a program to monitor pesticide residues in food and the environment.</span></p><p style="margin-top:0pt; margin-left:64.35pt; margin-bottom:0pt; text-align:justify; background-color:#ffffff"><span style="font-weight:bold; font-style:italic">5.2</span><span style="font-style:italic"> </span><span style="font-style:italic">Even in cases where a control program is in operation, the pesticide industry should:</span></p><p style="margin-top:0pt; margin-left:64.35pt; margin-bottom:0pt; text-align:justify; background-color:#ffffff"><span style="font-weight:bold; font-style:italic">5.2.1</span><span style="font-style:italic"> </span><span style="font-style:italic">cooperate in the periodic re-evaluation of pesticides marketed;</span></p><div style="margin-right:28pt; margin-left:132.35pt; background-color:#ffffff"><p style="margin-top:0pt; margin-left:18pt; margin-bottom:0pt; text-indent:-18pt; text-align:justify"><span><![if ¡supportLists]></span><span style="font-weight:bold">2.</span><span style="font-weight:bold"> </span><span><![endif]></span><span style="font-style:italic"> </span><span style="font-style:italic">provide centers dealing with pesticide poisoning treatment, and their medical staff, with information on hazards related to pesticides and on appropriate treatment;</span></p></div><p style="margin-top:0pt; margin-left:64.35pt; margin-bottom:0pt; text-align:justify; background-color:#ffffff"><span style="font-weight:bold; font-style:italic">5.2.3</span><span style="font-style:italic"> </span><span style="font-style:italic">make every reasonable effort to reduce the risks posed by pesticides:</span></p><p style="margin-top:0pt; margin-left:64.35pt; margin-bottom:0pt; text-align:justify; background-color:#ffffff"><span style="font-weight:bold; font-style:italic">5.2.3.1</span><span style="font-style:italic"> </span><span style="font-style:italic">making available less toxic formulations;</span></p><p style="margin-top:0pt; margin-left:64.35pt; margin-bottom:0pt; text-align:justify; background-color:#ffffff"><span style="font-weight:bold; font-style:italic">5.2.3.2</span><span style="font-style:italic"> </span><span style="font-style:italic">presenting products in ready-to-use containers;</span></p><p style="margin-top:0pt; margin-left:64.35pt; margin-bottom:0pt; text-align:justify; background-color:#ffffff"><span style="font-weight:bold; font-style:italic">5.2.3.3</span><span style="font-weight:bold; font-style:italic"> </span><span style="font-style:italic">developing application methods and equipment that minimize exposure to pesticides;</span></p><p style="margin-top:0pt; margin-left:64.35pt; margin-bottom:0pt; text-align:justify; background-color:#ffffff"><span style="font-weight:bold; font-style:italic">5.2.3.4</span><span style="font-weight:bold; font-style:italic"> </span><span style="font-style:italic">using returnable and refillable containers where effective container collection systems exist;</span></p><p style="margin-top:0pt; margin-left:64.35pt; margin-bottom:0pt; text-align:justify; background-color:#ffffff"><span style="font-weight:bold; font-style:italic">5.2.3.5</span><span style="font-weight:bold; font-style:italic"> </span><span style="font-style:italic">using containers that are not attractive or easy to reuse and promoting programs that discourage their reuse, where effective collection systems do not exist;</span></p><p style="margin-top:0pt; margin-left:64.35pt; margin-bottom:0pt; text-align:justify; background-color:#ffffff"><span style="font-weight:bold; font-style:italic">5.2.3.6</span><span style="font-weight:bold; font-style:italic"> </span><span style="font-style:italic">using containers that are not attractive to or easily opened by children, particularly for domestic use products;</span></p><p style="margin-top:0pt; margin-left:64.35pt; margin-bottom:0pt; text-align:justify; background-color:#ffffff"><span style="font-weight:bold; font-style:italic">5.2.3.7</span><span style="font-weight:bold; font-style:italic"> </span><span style="font-style:italic">using clear and concise labeling;</span></p><div style="margin-right:28pt; margin-left:124.35pt; background-color:#ffffff"><p style="margin-top:0pt; margin-left:18pt; margin-bottom:0pt; text-indent:-18pt; text-align:justify"><span><![if ¡supportLists]></span><span style="font-weight:bold">4.</span><span style="font-weight:bold"> </span><span><![endif]></span><span style="font-style:italic">halt sale and recall products when their handling or use entails an unacceptable risk under any of their use indications or restrictions.</span></p></div><p style="margin-top:0pt; margin-left:64.35pt; margin-bottom:0pt; text-align:justify; background-color:#ffffff"><span style="font-weight:bold; font-style:italic">5.3</span><span style="font-weight:bold; font-style:italic"> </span><span style="font-style:italic">Governments and industry should further cooperate in reducing risks by:</span></p><p style="margin-top:0pt; margin-left:64.35pt; margin-bottom:0pt; text-align:justify; background-color:#ffffff"><span style="font-weight:bold; font-style:italic">5.3.1</span><span style="font-weight:bold; font-style:italic"> </span><span style="font-style:italic">promoting the use of appropriate and affordable personal protective equipment (5);</span></p><p style="margin-top:0pt; margin-left:64.35pt; margin-bottom:0pt; text-align:justify; background-color:#ffffff"><span style="font-weight:bold; font-style:italic">5.3.2</span><span style="font-style:italic"> </span><span style="font-style:italic">establishing provisions for storing pesticides safely both in warehouses and on farms (26, 27);</span></p><p style="margin-top:0pt; margin-left:64.35pt; margin-bottom:0pt; text-align:justify; background-color:#ffffff"><span style="font-weight:bold; font-style:italic">5.3.3</span><span style="font-style:italic"> </span><span style="font-style:italic">establishing services for the collection and safe disposal of used containers and small quantities of unused pesticides (28);</span></p><p style="margin-top:0pt; margin-left:64.35pt; margin-bottom:0pt; text-align:justify; background-color:#ffffff"><span style="font-weight:bold; font-style:italic">5.3.4</span><span style="font-weight:bold; font-style:italic"> </span><span style="font-style:italic">protecting biodiversity and minimizing the adverse effects of pesticides on the environment (water, soil and air) and on non-target organisms.</span></p><p style="margin-top:0pt; margin-left:64.35pt; margin-bottom:0pt; text-align:justify; background-color:#ffffff"><span style="font-weight:bold; font-style:italic">5.4</span><span style="font-style:italic"> </span><span style="font-style:italic">To avoid cases of confusion and unjustified alarm among the public, interested parties should consider all available data and promote responsible dissemination of information about pesticides and their uses.</span></p><p style="margin-top:0pt; margin-left:64.35pt; margin-bottom:0pt; text-align:justify; background-color:#ffffff"><span style="font-weight:bold; font-style:italic">5.5</span><span style="font-style:italic"> </span><span style="font-style:italic">When establishing production facilities in developing countries, manufacturers and governments should cooperate to:</span></p><p style="margin-top:0pt; margin-left:64.35pt; margin-bottom:0pt; text-align:justify; background-color:#ffffff"><span style="font-weight:bold; font-style:italic">5.5.1</span><span style="font-style:italic"> </span><span style="font-style:italic">adopt technical standards and follow practices appropriate to the nature of the manufacturing operations and the consequent hazards, and ensure the availability of appropriate protective equipment;</span></p><p style="margin-top:0pt; margin-left:64.35pt; margin-bottom:0pt; text-align:justify; background-color:#ffffff"><span style="font-weight:bold; font-style:italic">5.5.2</span><span style="font-style:italic"> </span><span style="font-style:italic">take all necessary precautions to protect workers, other persons present, surrounding communities, and the environment;</span></p><p style="margin-top:0pt; margin-left:64.35pt; margin-bottom:0pt; text-align:justify; background-color:#ffffff"><span style="font-weight:bold; font-style:italic">5.5.3</span><span style="font-style:italic"> </span><span style="font-style:italic">ensure the appropriate location of manufacturing and formulation plants and adequate control of their wastes and effluents;</span></p><p style="margin-top:0pt; margin-left:64.35pt; margin-bottom:0pt; text-align:justify; background-color:#ffffff"><span style="font-weight:bold; font-style:italic">5.5.4</span><span style="font-style:italic"> </span><span style="font-style:italic">maintain quality assurance procedures, in order to ensure compliance with the relevant standards of purity, performance, stability and safety.</span><span>”</span></p><p style="margin-top:0pt; margin-left:64.35pt; margin-bottom:0pt; text-indent:28.35pt; text-align:justify; background-color:#ffffff"><span style="font-weight:bold">VIII.- ON THE REGULATION OF PESTICIDE REGISTRATION.</span><span> </span><span>The proper use of pesticides can be useful for the control and elimination of pests, for the benefit of the population's food security and the economic activity sustained by agricultural production. However, the potential risk that the use of such substances may imply for human health and the environment must be recognized. This has even motivated the adoption of international instruments with the express objective of protecting human health—including the health of consumers and workers—and the environment against the possible harmful effects of pesticides, as is the case of the Rotterdam Convention on the Prior Informed Consent Procedure for Certain Hazardous Chemicals and Pesticides in International Trade (Convenio de Rotterdam para la Aplicación del Procedimiento de Consentimiento Fundamentado Previo a Ciertos Plaguicidas y Productos Químicos Peligrosos Objeto del Comercio Internacional), which was approved by Costa Rica, through Law No. 8705 of February 13, 2009. In which case, before the mandatory legislative consultation on constitutionality brought before this Court (case file number 08-015252-0007-CO), prior to the approval of said international instrument, this Court indicated—in what is relevant—that:</span></p><p style="margin-top:0pt; margin-left:64.35pt; margin-bottom:0pt; text-align:justify; background-color:#ffffff"><span>“(…)</span><span> </span><span style="font-style:italic">the Costa Rican State has the duty to act effectively and proactively, to prevent the occurrence of events that degrade the environment and compromise its sustainability. From that perspective, undertaking, through an international treaty such as the one consulted, or through an internal act, to facilitate the rational use of chemically hazardous products subject to international trade, is not only possible, but entirely consistent with its constitutional duties. Pesticides and industrial chemical products are substances that can cause damage to human health and the environment. Faced with such a threat, the Rotterdam Convention provides the Parties with the possibility of knowing in advance the composition and effects of certain chemical products, which are expressly indicated in its Annex III. The suitable measures that the State takes to regulate the commercialization and use of said products in industrial, agricultural, etc. activities are in accordance with its duty to preserve the aforementioned values of constitutional rank. Hence, the duties that the State would assume if it definitively approves this Convention are legitimate, in accordance with the Law of the Constitution. It would be a sovereign decision of the State to submit to the obligations contained in the Convention, to contribute to the protection of people's health and the integrity of the environment, therefore it can be concluded that, in general terms, no defects of unconstitutionality are observed in the clauses of the Rotterdam Convention, the approval of which is submitted for consultation.</span><span>” (resolution number 2008-018207 at 18:15 hours on December 10, 2008)</span></p><p style="margin-top:0pt; margin-left:64.35pt; margin-bottom:0pt; text-indent:28.35pt; text-align:justify; background-color:#ffffff"><span>With this, it is verified that this Court has recognized the risk that the use of pesticides may entail and the importance of adopting suitable measures to regulate their use. In the Costa Rican legal system, there is diverse legal and regulatory normativity from which it follows that the activity of importing, manufacturing, commercializing, and using pesticides is heavily subject to the police power (potestad de policía) of the State, for the sake of guaranteeing the right to health and a healthy and ecologically balanced environment. One can cite, in the first place, the General Health Law (Ley General de Salud), which in its Article 213 provides:</span></p><p style="margin-top:0pt; margin-left:64.35pt; margin-bottom:0pt; text-align:justify; background-color:#ffffff"><span>“</span><span style="font-style:italic">ARTICLE 213.- Every natural or legal person engaged in producing food shall do so under sanitary environmental conditions and using defense or conservation techniques approved by the health authority, in order to mainly avoid the contamination of such products and their hazardousness due to the presence of toxic residues from their treatment with pesticides or other defense or conservation systems.</span><span>”</span></p><p style="margin-top:0pt; margin-left:64.35pt; margin-bottom:0pt; text-indent:28.35pt; text-align:justify; background-color:#ffffff"><span>Meanwhile, Article 244 of that same regulatory body establishes:</span></p><p style="margin-top:0pt; margin-left:64.35pt; margin-bottom:0pt; text-align:justify; background-color:#ffffff"><span>“</span><span style="font-style:italic">ARTICLE 244.- Natural and legal persons that import, manufacture, handle, store, transport, trade, supply or apply substances, mixtures of substances or products called pesticides by the plant health law, shall be subject to the regulatory provisions that the Ministry dictates jointly with the Ministry of Agriculture for the safeguarding of people's health. In accordance with that law, interested parties must register every pesticide or product intended for the control or extermination of infestations and request prior permission to operate when such substances, mixtures of substances or products that due to their nature or use are not included in the mentioned law are capable in any way of producing poisoning or serious damage to the health of people or animals that are useful or harmless to man.</span><span>”</span></p><p style="margin-top:0pt; margin-left:64.35pt; margin-bottom:0pt; text-indent:28.35pt; text-align:justify; background-color:#ffffff"><span>For its part, through the Phytosanitary Protection Law (Law No. 7664 of April 8, 1997), the phytosanitary protection measures established in that law and its regulations were declared of public interest and mandatory application (Art. 1). In addition, among the objectives of said law is included: “</span><span style="font-style:italic">Regulate the use and management of chemical, biological or related substances and equipment to apply them in agriculture; likewise, their registration, import, quality and residues, while at the same time seeking to protect human health and the environment</span><span>” (Article 2, subsection E). The competent authority in the matter is the State Phytosanitary Service (Servicio Fitosanitario del Estado), which is responsible—among other functions—for: “</span><span style="font-style:italic">Controlling chemical, biological or related substances for agricultural use, with regard to their inscription, import, export, quality, tolerance, residues, dosages, effectiveness, toxicity, presentation to the public, conservation, management, trade, general conditions of use, safety and precautions in transport, storage, disposal of containers and residues of such substances; likewise, controlling the equipment necessary to apply them and any other activity inherent to this matter</span><span>” (Article 5, subsection O).</span></p> In accordance with the foregoing, Articles 23, 24, 25, and 30 of said regulatory body provide:

"*ARTICLE 23.- Registration of substances and equipment.* *According to the requirements to be specified in the regulation of this law, all chemical, biological, or related substances and application equipment for agricultural use must be registered in the registry that the State Plant Health Service (Servicio Fitosanitario del Estado) shall create in order to have information on their characteristics and to ensure their correct use in the country.*" "*ARTICLE 24.- Registry of substances.* *No natural or legal person may import, export, manufacture, formulate, store, distribute, transport, repackage, rebottle, advertise, handle, mix, sell, or use chemical, biological, or related substances for agricultural use that are not registered in accordance with this law.* *Exempted from the indicated registry are chemical, biological, or related substances for agricultural use that enter in transit, for research, or to combat specific phytosanitary problems. In these cases, the permit shall only be granted temporarily for reasons of urgency, technically justified before the State Plant Health Service (Servicio Fitosanitario del Estado).* *The Service shall deny authorization when it is technically inappropriate and shall notify the interested party.*" "*ARTICLE 25.- Registration of persons.* *Any natural or legal person that registers, imports, exports, repackages, and rebottles chemical, biological, or related substances and application equipment for agricultural use must register in the registry kept by the State Plant Health Service (Servicio Fitosanitario del Estado), after fulfilling the requirements specified in the respective regulation.* *The Service may deny, suspend, or cancel the registration of chemical, biological, or related substances and of application equipment for agricultural use, by means of a substantiated technical resolution that conforms to due process, according to the respective regulation.*" "*ARTICLE 30.- Prohibitions and restrictions for technical reasons.* *The Ministry of Agriculture and Livestock (Ministerio de Agricultura y Ganadería) may restrict or prohibit the importation, transit, redestino, manufacture, formulation, rebottling, repackaging, storage, sale, mixing, and use of chemical, biological, or related substances and application equipment for agricultural use, when justified for technical reasons and their use is considered harmful to agriculture, health, or the environment*".

Finally, the Law for the Importation and Quality Control of Agrochemicals (Ley para la Importación y Control de la Calidad de Agroquímicos) (Law No. 7017 of December 17, 1985) states, in its Article 5, that:

"*ARTICLE 5.- For the purpose of ensuring the quality and use of agrochemicals, the Ministry of Agriculture and Livestock (Ministerio de Agricultura y Ganadería) is obligated to carry out periodic controls on the quality of these products in factories and distribution houses, where it shall take the necessary samples to send them to the quality control laboratory. This Ministry shall also be in charge of controlling chronic toxicity and its effect on the health of people and the environment. No product may be registered without these analyses having been performed. The Ministry of Agriculture and Livestock (Ministerio de Agricultura y Ganadería) may prohibit the circulation or order the destruction of products that do not comply with quality standards, as well as take other measures aimed at improving the quality of agrochemicals. Regarding the development and control of quality standards, the aforementioned Ministry shall act in coordination with the National Office of Standards and Units of Measurement (Oficina Nacional de Normas y Unidades de Medidas) of the Ministry of Economy and Commerce (Ministerio de Economía y Comercio)*." It follows from the previously cited regulations that, as a manifestation of the referred police power, the necessary registration of pesticides is included prior to authorizing their importation, manufacture, commercialization, or use, in order to exercise prior control regarding the due fulfillment of the corresponding technical quality and safety requirements, in protection of public health and the environment." From all of which, the following main ideas are extracted that serve as the basis for this note:

*The **right to food** as a human right imposes food safety and thereby requires the traceability of the product throughout the entire food chain ("from farm to table"). For this reason, control mechanisms are established for establishments, registries, and enrollment of inputs for agricultural use, even establishing agro-environmental liability standards when damages and losses are caused to agriculture, the environment, and human and animal health.

***Integrated food safety and agro-environmental control systems** are thus established to guarantee the safety of people, the environment, and plants and animals, and even to avoid excessive contamination of water resources.

*According to the **International Code** of Conduct on the Distribution and Use of Pesticides, which was first adopted in 1985 by the twenty-fifth session of the conference of the United Nations Food and Agriculture Organization (FAO), standards of conduct are established to serve as a framework and point of reference for the proper and rational use of pesticides, focusing on risk reduction, the protection of human and environmental health, and support for the development of sustainable agriculture through the effective use of pesticides. Moreover, see the **Rotterdam Convention** on the Prior Informed Consent Procedure for Certain Hazardous Chemicals and Pesticides in International Trade, which was approved by Costa Rica, through Law No. 8705 of February 13, 2009.

*The use of pesticides, while it may be **useful** for the control and elimination of pests, benefiting the food security of the population and the economic activity based on agricultural production, the **potential risk** that the use of such substances may imply for human health and the environment must also be recognized. Therefore, as a manifestation of the State's police power, the **necessary prior registration of pesticides** is included before authorizing their importation, manufacture, commercialization, or use, in order to exercise prior control regarding the due fulfillment of the corresponding technical quality and safety requirements, in protection of public health and the environment.

Furthermore, one must recall the constitutional jurisprudence on the principle of progressivity and the principle of non-regression in environmental matters.- The **principle of progressivity** imposes on the State the obligation to progressively increase, to the extent of its possibilities and development, the level of protection of the right to the environment. It is the obligation to develop and execute policies and standards aimed at progressively achieving the full effectiveness of the right to the environment. The **principle of non-regression** stands as a substantive guarantee of the right to a healthy and ecologically balanced environment, by virtue of which the State is obliged not to adopt measures, policies, or approve legal norms that worsen the situation of the rights achieved up to that point (see decision 2016-00415). In this case, it is noted that the decree repealed by the decree in question was much more adequate, complete, and rigorous for the entry and control of pesticides. This confirms the regressivity in this matter. Comparing the regulation made by the challenged decree with the previous regulation, the regressivity is evident, and with it, the non-progressivity in the protection of health and the environment in matters of regulation regarding the registration and use of pesticides in our country.

Grave danger to the environment and public health: The great concern expressed about the quality of pesticides that could be released into agricultural fields and the environment is alarming, since, first, the IAGT are registered by equivalence or revalidated, without the necessary technical information for a risk assessment to health and the environment, which contravenes the OECD recommendations (which establishes the need to carry out a risk assessment prior to the registration of chemical substances, as with pesticides); and second, by not requiring the submission of biological tests for the registration of formulated products containing unevaluated IAGT, a lack of knowledge of the effects on human beings and the environment is inferred, as well as an uncertainty as to whether the product fulfills its pest control function.

Transcendence of the topic in question for human health: The importance of the topic discussed must be remembered, as pesticides have a direct interference in human health. The agrochemical and biological substances used in agriculture can represent damage –or a risk of violation-. These agrochemicals reach directly the cultivated foods, and later, the tables of all consumers. In such a way that, agricultural inputs, particularly pesticides, are susceptible to causing irreparable damage to the environment and health, especially if used incorrectly, so the State must issue the standards and adopt the necessary measures so that all activity related to agrochemical products, particularly pesticides, is in accordance with the duty to preserve health and the environment. As mentioned by the plaintiff, the Human Rights Council of the United Nations General Assembly, through resolution 34/12 (A/HRC/RES/34/12), indicated regarding the right to food, approved on March 23, 2017, in its point 41, "*Invites States to promote practices that minimize the potential risks to health and the environment related to pesticides, while ensuring their effective use*". Additionally, Article 5 "Reduction of risks to health and the environment" of the International Code of Conduct on Pesticide Management, by FAO and WHO, establishes that governments should implement a pesticide registration and control policy and system in accordance with Article 6, which they transcribe, indicating policies and legislation, establishing systems and infrastructures so that each pesticide product is registered before it is available, risk assessments and adopting risk management decisions, and applying the principles described in the Manual on the development and use of FAO and WHO specifications for plant protection products, for the purpose of determining equivalence between pesticides.

Violation of the preventive principle, precautionary principle, pro natura principle, and principle of objectification of environmental protection: The challenged regulation is contrary to what the constitutional principles in environmental matters mandate: **preventive** principle (when there is certainty of possible damage to the environment, the affecting activity must be prohibited, limited, or conditioned upon the fulfillment of certain requirements. In general, this principle applies when there are clearly defined and identified risks at least as probable; likewise, this principle is useful when there are no technical reports or administrative permits that guarantee the sustainability of an activity, but there are sufficient elements to foresee eventual negative impacts), **precautionary** principle (when there is danger of serious and irreversible damage, the lack of absolute scientific certainty shall not be used as a reason to postpone the adoption of cost-effective measures to prevent environmental degradation. The principle starts from reasonable scientific uncertainty together with the threat of serious and irreversible environmental damage), **pro natura** principle (in case of doubt or uncertainty, controversies must be resolved and norms must be interpreted in favor of the protection and conservation of the environment) and the principle of **objectification of environmental protection** (or principle of linkage to science and technology, according to which it is required to accredit with technical studies the decision-making in this matter, both in relation to acts and provisions of a general nature -both legal and regulatory-, from which the requirement of "linkage to science and technology" is derived, with which, the discretion of the Administration in this matter is conditioned. It has been defined as principle number 17 of the Rio Declaration on the Environment). When faced with a situation that requires the application of the precautionary principle, public entities and bodies must refrain from authorizing, approving, or permitting any new or modification request that reasonably implies a serious risk; they are even obligated to suspend activities that are underway, and likewise must simultaneously adopt efficiently all measures required for the preservation of a healthy and ecologically balanced environment. Therefore, the application of the precautionary principle implies that when there are indicators that a certain activity could plausibly cause serious and irreversible damage to the environment, the lack of absolute certainty or scientific evidence in this regard does not exempt from the obligation to adopt all those efficient and effective measures to prevent a violation of the environment. Furthermore, in consideration of the theory of *Drittwirkung der Grundrechte*, this principle extends its guiding function to the conduct of subjects of both public and private law.

The foregoing is violated by the decree in question. Thus, to further highlight the importance of protecting the right to the environment, health, and food safety, and in application of the constitutional environmental principles of progressivity and non-regression, precautionary principle, preventive principle, in dubio pro natura principle, and the principle of objectification, I have considered recording this note in the terms expressed.

**Fernando Cruz Castro** 1 Likewise, Article 46 in fine enshrines the right of all consumers and users to the protection of their health, environment, safety, and economic interests. These were the constitutional principles that the legislator took into consideration when enacting the Ley de Protección Fitosanitaria, No. 7664 of April 8, 1997. Among its main objectives are to avoid and prevent the introduction and spread of pests, to protect plants from the damage caused by them, to regulate their combat, to promote integrated pest management (manejo integrado de plagas) within sustainable development programs, to regulate the use and management of chemical, biological, or related substances and the equipment for applying them in agriculture, as well as to prevent phytosanitary measures from constituting an unnecessary obstacle to international trade (Article 2).

The Law provides a special procedure for addressing phytosanitary emergencies that could compromise food security and the country's economy, and grants the Administration certain powers to adopt all measures necessary to control a situation of that nature. If it is the constitutional duty of the State to organize national production, it is consequently also its duty to design mechanisms for controlling pests that may negatively affect it, for which purpose various techniques are employed, such as the declaration of quarantines, the destruction of plants, the control of entry and country of origin of plants or biological control agents, integrated pest management, among others. In this sense, combating pests must be a shared effort between the State and the private individuals involved in a situation of this nature. However, if in a specific situation a private individual does not comply with the guidelines issued by the State Phytosanitary Service (Servicio Fitosanitario del Estado) for combating a pest, the Administration not only may but is obligated to substitute for them and execute the necessary control work to allow for the timely containment of existing sources of infection. Now then, such conduct by the Administration should not generate any patrimonial liability for it, because it is motivated precisely by the omission of the private individual, who is the first called upon to combat the infectious situation in accordance with the instructions given to that effect by the Phytosanitary Service. This is the reason that justifies the exemption from liability established in the challenged Article 15. The protection of public order is above individual interest, but it is the negligence of the private individual that justifies that, notwithstanding the fact that the Administration's actions cause them damage of exceptional intensity, there is no legal basis to claim any indemnity from the State, especially considering that such negligence can not only affect the individual, but can also compromise the well-being and general interest of society.

The negligence and omission of the private individual thus oblige the Administration to deploy its police power (poder de policía) in order to protect the social public interest. When we speak of "police power" in a broad sense, we refer to that set of measures aimed at protecting public safety, morality, and health, as well as the defense and promotion of the economic interests of the community and its general well-being. It manifests, in principle, as a power attributed to the legislative power and is therefore non-delegable. However, the legislator may create in ordinary law an imputation of functions, assigning to the executive power, for example, the authority to regulate on certain matters, within the limits pre-established in the law; such is what occurs in the present case. The Ley de Protección Fitosanitaria grants the Executive Power, through the Ministry of Agriculture and Livestock (Ministerio de Agricultura y Ganadería), the necessary powers to control possible sources of infection and/or pests." (The highlighting does not correspond to the original).

Along these same lines, this Tribunal has been aware that the chemical components used to contain pests in agricultural products have a clear and notable impact on the environment (soil saturation and fertilization), but also on food security (access to food), and, therefore, it is necessary for the State to assume a proactive and vigilant conduct in the matter. Indeed, the State has the obligation to regulate the use of chemical or related substances for agricultural use, so that they are handled correctly, reasonably, and do not generate risks to human health and the environment. Furthermore, it has the responsibility to guarantee the well-being of the inhabitants and an ecologically balanced environment. In judgment No. 2021-019096, the following was resolved:

"VI.- ON THE REGULATION OF THE USE OF PESTICIDES As indicated above, the right to life, to health, and to a healthy environment are fundamental rights regulated in Articles 21 and 50 of the Political Constitution and their protection is of public interest. Precisely, it is for this reason that the State has the obligation, in order to protect the health of the population, and the precautionary principle in environmental matters to regulate the use of chemical or related substances for agricultural use, so that they are handled correctly, reasonably, and do not generate risks to human health and the environment. Furthermore, it also has the responsibility to guarantee the well-being of citizens and an ecologically balanced environment. In this regard, the Chamber has established that the State must have a guarantor role regarding the proper use of pesticides and the avoidance of their harmful effects on health and the environment. In this sense, in Judgment No. 2004-13968 of 11:35 a.m. on December 3, 2014, it indicated:

"III.- That report [FOE-AM-19/2004 of October 20, 2004, carried out by the Agricultural Services and Environment Area of the Operative and Evaluative Oversight Division of the Contraloría General de la República, on the evaluation of the State's management concerning the control of agricultural pesticides] originated from the need to supervise the administrative process related to one of the most pressing environmental problems that the country must solve, which is the use of chemical, biological, or related substances in agricultural activities, and from the need for the State to intervene by exercising a regulatory function over the use of agrochemicals, which guarantees farmers the availability in the market of effective products for combating pests and, at the same time, the protection of the health of the general citizenry and their right to a healthy and ecologically balanced environment. It was indicated in the report that this control is exercised mainly by the Ministry of Agriculture and Livestock, through the State Phytosanitary Service (Servicio Fitosanitario del Estado), which must work in coordination with the Ministry of Health and the Ministry of Environment and Energy, regarding control over impacts on health and the environment, as well as with the Ministry of Finance regarding the import and exoneration of such products. Its general objective was to evaluate the State's management in relation to the control of pesticides used in agricultural activities and their effect on the environment and human health, mainly the actions of the State Phytosanitary Service of the Ministry of Agriculture and Livestock (MAG); and the specific objectives of the study were: a) to evaluate national policies and leadership in the field of control over pesticide use, identifying the participating institutions and their competencies, b) to evaluate the pesticide registration process in the country and the associated regulations, c) to evaluate the exoneration and import process of pesticides in the country, and d) to evaluate the oversight and monitoring of pesticide use.

IV.- In that report, the Contraloría concluded that the State Phytosanitary Service (SFE) does not fulfill its creation objectives with efficiency and adherence to the principle of legality, which call upon it to regulate, execute, and supervise the registration and use of agrochemicals, within the framework of an agricultural activity in harmony with nature and with faithful compliance with the constitutional principles of the right to life, to health, and to a healthy environment. It determined that, on the contrary, the actions of said body are oriented towards facilitating the registration and commercialization of such substances, justified by a supposed interest in improving the competitiveness of agricultural producers, but rather, those objectives seem aimed at promoting competition in the pesticide market, above the constitutional rights of the farmers themselves and the environmental and human health principles. It concluded that the companies most benefited by the facilitating function of the SFE have been the companies dedicated to the sale of agrochemicals, especially those referred to as generics, to the detriment of producers and consumers of agricultural goods. It clarified that this does not mean that pesticides of this type cannot be registered in the country, but rather that their registration must be done respecting the regulations and ensuring the Costa Rican population the protection of their health and the fundamental right they have to a healthy and ecologically balanced environment, and protecting the national farmer's right to have good quality inputs; without prejudice to the necessary actions that the State must execute to seek the gradual reduction of pesticide use and the promotion of alternative mechanisms. These considerations motivated the Contraloría General de la República to issue a series of final provisions directed to the President of the Republic and the Ministers of National Planning and Economic Policy, Agriculture and Livestock, Health, Environment and Energy, and Economy, Industry and Commerce, as well as to the Internal Auditor of the Ministry of Agriculture and Livestock." Similarly, in Judgment No. 2006-09565, of 4:08 p.m. on July 5, 2006, this Tribunal considered:

"( ... ) it is evident that the Costa Rican State has the duty to act effectively and in advance, to avoid the occurrence of events that degrade the environment and compromise its sustainability." And, in No. 2011-016937 of 2:36 p.m. on December 7, 2011, it ruled:

"( ... ) VIII.- ON REGULATION IN THE MATTER OF PESTICIDE REGISTRATION. The proper use of pesticides can be useful for the control and elimination of pests, benefiting the population's food security and the economic activity based on agricultural production. However, the potential risk that the use of such substances can entail for human health and the environment must be recognized. This has even motivated the adoption of international instruments with the express purpose of protecting human health - including the health of consumers and workers - and the environment against the possible harmful effects of pesticides, as is the case of the Rotterdam Convention on the Prior Informed Consent Procedure for Certain Hazardous Chemicals and Pesticides in International Trade, which was approved by Costa Rica, through Law No. 8705 of February 13, 2009.

( ... ) this Tribunal has recognized the risk that the use of pesticides can entail and the importance of adopting suitable measures to regulate their use. In the Costa Rican legal system, there is diverse legal and regulatory legislation from which it is derived that the activity of importation, manufacturing, commercialization, and use of pesticides is strongly subject to the police power of the State, in order to guarantee the right to health and to a healthy and ecologically balanced environment." (Considerations that were reiterated in judgment No. 2021-024807).

Echoing these constitutional principles, legal regulations declared of public interest have been issued by the legislator to address this important matter. For example, the aforementioned Ley de Protección Fitosanitaria in Article 1 states that "the phytosanitary protection measures established in this law and its regulations" are declared "of public interest and mandatory application"; the Ley General de Salud (declared of public interest in Article 7) also contains general provisions regarding the management of these substances; and the Ley de Uso, Manejo y Conservación de Suelos (also of public interest by virtue of the express provisions in Articles 3 and 61 of the law) includes provisions and competencies in favor of MINAE regarding activities that may cause soil contamination (see Article 28 et seq.).

In this way, a very broad scope of action of the Costa Rican State concerning the use of agrochemicals is observed, which includes regulating both the use and management of chemical, biological, or related substances and equipment for applying them in agriculture as well as their registration, importation, quality, and residues, while simultaneously seeking to protect human health and the environment.

Concerning the object of this unconstitutionality action, the topic of the "registration" (inscripción) of products is of particular interest, which is regulated in a more detailed manner in Articles 23, 24, and 25 of the Ley de Protección Fitosanitaria. These establish registration and enrollment, as one of the control mechanisms for establishments and inputs for agricultural use. Specifically, and of particular relevance to this unconstitutionality action, Article 23 of the law states the following:

"Art. 23 - Registration of substances and equipment According to the requirements to be specified in the regulation of this law, all chemical, biological, or related substances and application equipment for agricultural use must be registered (inscribirse) in the registry that the State Phytosanitary Service will create to have information on the characteristics of these and to ensure their correct use in the country." As will be examined below, the regulations subject to this action respond precisely to this obligation of the State, entrusted to the SFE, to maintain the updated registry of substances used for agricultural purposes.

V.- BACKGROUND IN THE CONSTITUTIONAL JURISDICTION The matter under analysis has been examined from different perspectives by this Tribunal.

In judgment No. 2017-06668, on the constitutionality of Decreto Ejecutivo No. 39995-MAG (which was later amended by the decree subject to this action), the following was resolved:

"ON THE MERITS. ABOUT THE ALLEGED VIOLATION OF THE RIGHT PROTECTED IN ARTICLE 50 OF THE POLITICAL CONSTITUTION, RELATING TO A HEALTHY AND ECOLOGICALLY BALANCED ENVIRONMENT. The plaintiff accuses a violation of the right protected in Article 50 of the Political Constitution, specifically, of the precautionary principle and the principle of reversal of the burden of proof in environmental matters, given that, on the one hand, the normative provisions under discussion require the Administration to prove the existence of an unacceptable risk to human health, the environment, or agriculture, in order to restrict or prohibit the registration of an active ingredient and formulated pesticide, despite the scope of the aforementioned principle and, on the other hand, the fact that, according to the impugned regulations, it falls upon the Administration, not the holder of the activity, to demonstrate the existence of a risk to the mentioned legal interests, when the principle in question demands the opposite. In this regard, Article 7 of Decreto Ejecutivo No. 39995-MAG, Reglamento para la actualización de la información de los expedientes de registro de ingrediente activo grado técnico y plaguicidas formulados (which is, in essence, what the plaintiff challenges), stipulates the following:

"ARTICLE 7. During the validity period of a registration, when the competent Ministries demonstrate an unacceptable risk to human health, the environment, or agriculture, the State Phytosanitary Service will restrict or prohibit its use." The norm, per se, aims to protect the environment and human health, since it precisely seeks to restrict or prohibit the use of a valid registration when an unacceptable risk exists; consequently, far from harming those constitutional interests, it safeguards them. When proceeding to register an active ingredient or pesticide is the appropriate time to apply the precautionary principle. It is to be assumed that during this procedure for enrolling a registration, the circumstance may arise that there is some technical or scientific doubt about the product's impact on human health, the environment, or agriculture. It is at that moment of processing that the precautionary principle can be applied, that is, in the face of doubt, the administration must decide not to enroll a registration. The impugned regulatory norm, that is, Article 7, refers to a stage subsequent to this, as it assumes that the enrollment procedure has already been conducted, concluded, and the registration already exists. Consequently, to annul a previously processed registration, the demonstration of an unacceptable risk is indeed required. On the other hand, as already indicated, the norm is protective of human health and the environment, for which it contemplates an authority of the public administration such as the restriction or prohibition of the use of a registration, even though there is a prior substantial legal situation in favor of the administered party, such as the registration.

IV.- ON THE VIOLATION OF THE PROVISIONS OF ARTICLE 146 OF THE POLITICAL CONSTITUTION. Nor does the Constitutional Chamber consider that the omission of the Minister of Health and the Minister of Environment to sign the Decree constitutes a defect of unconstitutionality in the challenged regulations, given that, as the plaintiff acknowledges, the impugned Decree was issued jointly by the President of the Republic and the Minister of Agriculture, meaning no impact on the provisions of Article 146 of the Political Constitution is observed, despite what the plaintiff claims in this regard. By virtue of the foregoing, the action must also be rejected on the merits, regarding this point." (The highlighting does not correspond to the original).

These considerations are especially significant for the specific case, insofar as they make it clear that in order to revoke an already authorized registration, it must be justified that there is a demonstration of an unacceptable risk to human health and the environment. Likewise, it was emphasized that the omission of the Minister of Health and the Minister of Environment to sign the decree does not constitute a defect of unconstitutionality in the challenged regulations.

Subsequently, in judgment No. 2017-007766, the following was resolved:

III.- SPECIFIC CASE. Prior to the resolution of this amparo appeal (recurso de amparo), it must be noted that the purpose of the amparo appeal is to provide timely protection against violations or threats to fundamental rights and freedoms, not to serve as a generic instrument to guarantee the principle of constitutional supremacy or the principle of legality. For that reason, the Chamber cannot establish itself, through this means, as an abstract comptroller of the constitutionality of infra-constitutional norms. Hence, pursuant to Article 30 paragraph a) of the Law governing this jurisdiction, amparo is not appropriate in this case against laws or other normative provisions, except when they are challenged jointly with acts of individual application thereof, or when dealing with norms of automatic action, in which case the procedure regulated in Articles 73 et seq. of the Ley de la Jurisdicción Constitucional must be used. According to the assumptions just mentioned, amparo is not appropriate in this case.

IV.- NOTE FROM JUDGES CRUZ CASTRO AND RUEDA LEAL. By resolution No. 2017006668 of 10:50 a.m. on May 10, 2017, an unconstitutionality action against Decreto Ejecutivo No. 39995-MAG, Reglamento para la actualización de la información de los expedientes de registro de ingrediente activo grado técnico y plaguicidas formulados was rejected on the merits. In said judgment, Judges Cruz Castro and Rueda Leal dissented and ordered that the action proceed, because we considered that the issue merited elucidation through the unconstitutionality action procedure.

V.- SEPARATE NOTE FROM JUDGE HERNÁNDEZ LÓPEZ.

I concur with the majority vote in this amparo action, however I must expressly state that my position was to proceed with the action filed at the time by the interested parties in relation to this matter.— My reasons were as follows:

"From my perspective, the decree establishes procedures to bring a group of pesticide registrations up to date with current technical requirements and assures those who manage to meet such conditions not only a new authorization period (Article 6), but also the guarantee (Article 7) that state authorities will not hinder their business except when they can demonstrate 'an unacceptable risk to human health, the environment, or agriculture.' Read in this way (as proposed by the plaintiff), the norm seeks to provide the owners of the registrations with a guarantee against State actions regarding their products, but at the cost—according to the appellant—of sacrificing the precautionary principle (principio precautorio) which holds constitutional rank.— I consider that the Costa Rican legal system constitutionally and conventionally obligates the State to protect public health, such that if a person reasonably demonstrates a certain, real, and imminent risk to public health from the effects of a registered pesticide, the state authorities have the duty to act, regardless of whether that product is registered or not, because such registration could not be placed above a legal interest such as public health. History documents numerous examples of pesticides such as Nemagon or DDT which, despite having passed the tests and filters that existed at the time to guarantee their viability, turned out not to be harmless to human health.

The contested norm is embedded within a normative framework of protection at the constitutional and conventional level that obligates the authorities—even ex officio—to issue the precautionary measures (medidas cautelares) they deem necessary when a harm (certain, real, and imminent harm to the health of the inhabitants) is reasonably established, in such a way that the phrase 'unacceptable risk' is not one that must be conclusively proven by the administration, or that imposes the burden of proof on the administered party, but rather one that—as indicated supra—is reasonably demonstrated from concrete facts, a protection for which the legal system provides, among other legal instruments, protection through the amparo action (recurso de amparo).

Similarly, regarding the precautionary principle in environmental matters, this Constitutional Court has taken important steps, as seen for example in the doctrine that can be extracted from judgment No. 2004-1923 of 2:55 p.m. on February 25, 2004, where the postulate that absolute scientific certainty should not be used as a reason to postpone the adoption of cost-effective measures to prevent environmental degradation is extensively developed (…)

The transcribed judgment is binding for state authorities in such a way that both the right to health and the precautionary principle in environmental matters obligate the State to act even in the face of mere risk, provided of course that it is certain, real, and imminent, whereby the discussed norm could not negate—and from my perspective it does not—the State's obligation to act in protection of these legal interests, an action that is supported by constitutional and conventional norms. In that sense, I do not believe the norm has, in itself, a wording that clashes with the indicated values, but if its application were to occur in a framework that threatens the stated interests, the legal system has—above said norm of mere regulatory value—the immediate precautionary remedies (remedios cautelares) that the administered party can request in protection of the same, among them, that of the amparo action.

Consequently, for the reasons stated, I consider that the norm, in its content, can never per se negate the constitutional and conventional obligation that the State has in protecting health and the environment." I hereby clarify my position in that case and the reasons why I now concur with the majority.

Likewise, the Chamber referred to the constitutionality of decree n.°40059-MAG-MINAE-S, “RTCR 484:2016. Agricultural Inputs, Formulated Synthetic Pesticides, Technical Grade Active Ingredient, Adjuvants and Related Substances for Agricultural Use. Registration, Use and Control,” whose purpose was to regulate the registration process for formulated synthetic pesticides, technical grade active ingredient, adjuvants, and related substances for agricultural use from the SFE. Its scope of application consists of natural or legal persons who register, commercialize, import, formulate, manufacture, repackage, refill, store, distribute, and handle formulated chemical pesticides, technical grade active ingredient, adjuvants, related substances, as well as those of mineral origin and inorganic salts. Through vote n.°2022-023238, the majority dismissed the unconstitutionality action. From the foregoing, it is observed that said regulation was applicable to new registration processes.

On the other hand, in vote n.°2022-026651, this court referred to the constitutionality of decree n.°39995-MAG, called “Regulation for the Updating of Information of the Registration Files for Technical Grade Active Ingredient and Formulated Pesticides” and, by majority, the unconstitutionality action was dismissed. Said decree and the one being examined in this case do not specifically refer to a process of registration or inscription of new pesticides, but rather their regulation is applicable to products that are already on the market, but whose registration was carried out under different parameters that did not require the prior registration of the IAGT, for which reason the Executive Branch deemed it essential to update the information of these registrations and also to establish a validity period equal to that of the registrations granted under current regulations. Precisely in said constitutionality process, it was explained that decree n.°39995-MAG of December 15, 2016, is a regulation designed for the updating of information of the registration files for technical grade active ingredient (IAGT) and formulated pesticides. The regulation seeks to achieve the registration of all chemical, biological, or related substances for agricultural use, of long-standing use in the SFE registry. This includes all those chemical entities not registered because the legislation did not establish it as a mandatory requirement. In this way, from this Regulation onwards, no IAGT and/or formulated product marketed in Costa Rica should be unknown to the State, and, better yet, said regulation seeks to have updated information that allows for better control. Thereby it brings the technical and scientific information of old registrations up to date by associating the IAGTs with those registered under the regulations by which they were originally inscribed. In this manner, it opens the possibility for the State to have the confidential chemical information that is lacking in the files of old registrations. Based on these premises, the constitutional grievances formulated in the specific case will be examined next.

VI.— ON LEGAL COMPETENCIES In the first place, the plaintiff asserts that the Ministry of Health and MINAE must actively participate in this process of registration, post-registration, and revalidation or updating of pesticide information, since the substances have a direct or indirect impact on the environment in general and consequently on people's health. He questions, therefore, that the decree grants the authority to only the SFE to grant registration unilaterally, without the participation of the other ministries, which in his opinion implies a regression in the level of protection and a violation of the principle of objectification of environmental protection (principio de objetivación de la tutela ambiental).

The Minister of Agriculture and Livestock explained, in this regard, that the legal and technical norms relating to phytosanitary protection must be interpreted in accordance with the constitutional duty of the State and of society in general to act in prevention of environmental risk and of both human and animal health, as is indeed done when issuing both executive decree n.°39995-MAG and n.°41481-MAG. He indicated that the legislator conferred upon the SFE the competence for achieving the purposes contained in the Phytosanitary Protection Law and that said assignment of competences is exclusive to said body, within which falls the carrying out and custody of the respective registrations. To this effect, the provisions of the Plant Health Law (Ley de Sanidad Vegetal) and the Phytosanitary Protection Law (Ley de Protección Fitosanitaria) are cited. The latter expressly establishes the competence regarding the registration and control of pesticides for agricultural use in the SFE.

On this point, the PGR noted that the contested decree does not include the participation of the Ministry of Health and MINAE, and, therefore, carries the same defect as decree 39995, unless the Chamber considers that the competences attributed to other bodies in their respective enabling laws are not repealed or modified by the contested norm, and that the SFE—within the exercise of its legal competences—can and must require the participation of any specialized technical body to verify that a pesticide does not pose a threat to health and the environment.

In this regard, the Chamber does not find that it specifically constitutes an injury to the Law of the Constitution. The fact that the ordinary legislator decided to concentrate the competences of phytosanitary protection in a specific authority of legal creation such as the SFE, attached to the MAG, does not in any way imply an injury to any provision of our Political Constitution. It corresponds to a specific organic and competence-design decision that is of free configuration for the legislator and that, moreover, does not nullify the governing authority that the Ministry of Health or MINAE may have in matters within their own jurisdiction. To this effect, the legislator provided broad competences in favor of the SFE precisely regarding phytosanitary protection. To this effect, Art. 5 of the Phytosanitary Protection Law, n°7664, establishes the following:

“ARTICLE 5.- Functions and obligations The State Phytosanitary Service shall have the following functions:

• a)Ensure the sanitary protection of plants.
• b)Advise on phytosanitary protection matters and recommend the issuance of the necessary legal norms in this field.
• c)Coordinate with other ministries and their dependencies, the pertinent actions for compliance with this Law and its Regulations. It shall be an auxiliary and assistant body to the General Directorate of Customs of the Ministry of Finance, in the control and oversight of the entry and values of merchandise or agricultural products.

(As amended by Article 3 of Law No. 8373 of August 18, 2004).

• d)Prepare, recommend, coordinate, execute, and disseminate the regulations and provisions that guarantee the application of this law.
• e)Order and execute the technical, legal, and administrative measures to avoid, prevent, and delay the introduction or establishment of new pests in plants.
• f)Eradicate, control, or slow the spread of already-introduced pests.
• g)Carry out phytosanitary control of the national and international exchange of plants, biological control agents and other types of organisms used in agriculture, packaging and conditioning materials, and means of transport capable of spreading or introducing pests that threaten food security and the economic activity on which agricultural production is based.
• h)Formulate, execute, and supervise programs for the detection and survey of pests, as well as emergency plans.
• i)Study and diagnose the phytosanitary status of the country.
• j)Establish and keep updated a national information system regarding the phytosanitary status.
• k)Officially declare the presence of pests and their quarantine importance.
• l)Evaluate and regulate, in the area of phytoprotection, any production method.
• m)Organize, endorse or not endorse, and support the preparation, dissemination, and application of programs for the prevention and combat of existing pests.
• n)Promote and control the integrated management of pests and the appropriate methodologies used.
• ñ)Control the phytosanitary quality of propagation material.
• o)Control chemical, biological, or related substances for agricultural use, regarding their registration, import, export, quality, tolerance, residues, dosages, effectiveness, toxicity, public presentation, conservation, handling, commerce, general conditions of use, safety, and precautions in transport, storage, disposal of containers and residues of such substances; likewise, control the equipment necessary to apply them and any other activity inherent to this matter.
• p)Control the phytosanitary quality of export plants to issue phytosanitary certificates, in accordance with the international treaties in force on the matter, this law, and its regulations.
• q)Regulate, in the area of phytoprotection, the import, export, research, experimentation, movement, multiplication, industrial production, commercialization, and use of transgenic materials and other genetically modified organisms for agricultural use or their products.
• r)Promote, support, and endorse the phytosanitary scientific research that is required.
• s)Manage the technical and financial support of national and international bodies to strengthen the State Phytosanitary Service.
• t)Recommend to the Executive Branch the ad honorem appointment of phytosanitary authorities.
• u)Ensure the administration, control, and use of the resources obtained by applying this law.
• v)Provide, by prior agreement, training, advice, and consulting in matters of phytosanitary protection.
• x)Promote the international harmonization of phytosanitary measures.

The controls mentioned in this article may be carried out in full or randomly, as established through technical criteria.” (The highlighting does not correspond to the original).

From the foregoing, it is clear that the competence to “control chemical, biological, or related substances for agricultural use, regarding their registration” was expressly assigned by the legislator to the SFE, without prejudice—as provided in the same article—to coordinating with other ministries and their dependencies the pertinent actions for compliance with this law and its regulations.

Furthermore, the law expressly establishes that substances must be registered in the registry that the SFE is precisely tasked with creating and maintaining, and it also provides the consequences for not conforming to the procedure:

“Art. 23. Registration of substances and equipment.

According to the requirements to be specified in the regulation of this law, all chemical, biological, or related substances and application equipment for agricultural use must be registered in the registry that the State Phytosanitary Service shall create to have information available on their characteristics and to ensure their correct use in the country.

Art. 24.- Registry of substances No natural or legal person may import, export, manufacture, formulate, store, distribute, transport, repackage, refill, advertise, handle, mix, sell, or use chemical, biological, or related substances for agricultural use that are not registered in accordance with this law. (…)” It is required, of course, that these competences must be exercised within the framework of the constitutional rights to health and to a healthy environment, and that the SFE authorities must in all cases safeguard such rights.

In this regard, it is necessary to emphasize that this Court, in judgment n.°2022-023238, already established that, although the registrations are under the competence of the SFE, the other aforementioned ministries have the possibility of warning, within their area of competence, of the existence of prohibited materials or materials subject to new restrictions in accordance with the international regulations that fall under such competences. It was warned that this type of regulation does not imply that the other functions of the two ministries are diminished or that they cannot play an active role of participation and collaboration, prior to granting registration or in the oversight function, when a registration fails to comply with international obligations due to the use of internationally prohibited products; for example, the international standards of unacceptable risks to health and the environment (see judgment n.°2022-023238).

Indeed, in the report rendered in case file no. 18-009107-0007-CO, the PGR stated the following:

“[T]he possible flexibility in the pesticide registration procedure introduced by decree no. 40059-MAG-MINAE-S in pursuit of providing the agricultural sector greater access to lower-cost products or inputs cannot undermine the legal competence of the technical bodies of MAG, MINAE, and MINSA to require whatever information they deem pertinent and to determine, through rigorous evaluations and data analyses, that the requested agrochemicals are harmless to human health and the environment.” (The highlighting does not correspond to the original).

Furthermore, it must be observed that the criticisms made by the claimant —in light of the CGR’s considerations— had a different normative context, precisely because in response to those recommendations and omissions, a transitory measure was expressly adopted in executive decree no. 40059 “Technical Regulation: ‘RTCR 484:2016. Agricultural Inputs. Formulated Synthetic Pesticides, Technical Grade Active Ingredient, Adjuvants, and Related Substances for Agricultural Use. Registration, Use and Control,’” effective as of July 13, 2017, which is precisely aimed at providing MAG and SFE with suitable technical instances to resolve all matters relating to agrochemical registrations and expressly establishes that such instance must operate “without prejudice to the constitutional or legal competences corresponding to the Ministries of Health or Environment”:

“TRANSITORY FIVE: The Ministry of Agriculture and Livestock shall establish within its structure, within a period of twelve months from the effective date of this decree, the Evaluation Areas: chemical, agronomic, toxicological, and ecotoxicological, as part of the Agrochemical and Application Equipment Registration Unit, and which shall be in charge of the review, verification of compliance with requirements, evaluation, and qualification of the documents and toxicological, ecotoxicological, and environmental fate studies established by this regulation in the different registration modalities, without prejudice to the constitutional or legal competences corresponding to the Ministries of Health or Environment.” (The highlighting does not correspond to the original).

Consequently, it is the responsibility of the national technical authorities, in accordance with the broad powers granted by the legal system, to carry out the procedure for updating the information in the registration files of technical grade active ingredient and formulated pesticides with the utmost rigor and care, in order to safeguard the fundamental rights to health and a healthy environment of all inhabitants. Thus, the ultimate responsibility for deciding whether or not to authorize the request for updating the products lies with the national authorities. In this regard, in judgment no. 2022-023238, it was concluded that in each specific petition —in the specific case, it refers to the updating of information in the registration files of technical grade active ingredient and formulated pesticides—, it is incumbent upon our national authorities to be vigilant regarding the studies submitted to them for assessment, and it does not imply, in any way, an authorization for them to relax the process and vigilance that must be carried out.

On this point, it should be added that, even if we had the highest regulatory standards, that alone would not be sufficient if the national authorities do not responsibly exercise the competences that concern them. In that sense, a dismissal of the grievance does not imply endorsing that the authorities are not vigilant a priori and a posteriori. On the contrary, this Chamber understands that, even at the slightest trace of doubt, they must proceed to require all pertinent documentation or studies, with the purpose of verifying that the product whose registration is to be updated meets the parameters and conditions necessary to safeguard human health. Likewise, it is their responsibility to ensure that its use is appropriate and has the desired effects. The rigor in the selection of studies is as important as the subsequent controls that may be carried out in the application and use of the products.

It is opportune to cite the reflections made by this Chamber in judgment no. 2011-016937, regarding knowledge of other regulations pertaining to the registration of pesticides:

“VII.- ON THE REDUCTION OF RISKS TO HEALTH AND THE ENVIRONMENT, PURSUANT TO ARTICLE 5 OF THE INTERNATIONAL CODE OF CONDUCT ON THE DISTRIBUTION AND USE OF PESTICIDES. It is of interest to refer to the provisions of the cited International Code of Conduct on the Distribution and Use of Pesticides, which was adopted, for the first time in 1985, by the Twenty-fifth Session of the Conference of the Food and Agriculture Organization of the United Nations (FAO). As explained in the preface to the revised version (adopted by the 123rd Session of the FAO Council, November 2002), this code of conduct was adopted and has been revised for the purpose of achieving greater food security while, at the same time, protecting human health and the environment. To that end, standards of conduct are established that are to serve as a framework and reference point for the proper and rational use of pesticides, focusing on risk reduction, the protection of human and environmental health, and support for the development of sustainable agriculture through the effective use of pesticides [source: (Source: http://www.fao.org/agriculture/crops/core-themes/theme/pests/pm/code/en/(05/08/11))] (…)

VIII.- ON THE REGULATION OF PESTICIDE REGISTRATION. The proper use of pesticides can be useful for the control and elimination of pests, benefiting the food security of the population and the economic activity based on agricultural production. However, the potential risk that the use of such substances may pose to human health and the environment must be recognized. This has even motivated the adoption of international instruments with the express objective of protecting human health —including the health of consumers and workers— and the environment from the possible harmful effects of pesticides, as is the case of the Rotterdam Convention on the Prior Informed Consent Procedure for Certain Hazardous Chemicals and Pesticides in International Trade, which was approved by Costa Rica through Law No. 8705 of February 13, 2009. In which case, regarding the mandatory legislative consultation of constitutionality raised before this Tribunal (case file number 08-015252-0007-CO), prior to the approval of said international instrument, this Tribunal stated —in what is relevant— that:

“(…) the Costa Rican State has the duty to act effectively and in advance to prevent the occurrence of events that degrade the environment and compromise its sustainability. From that perspective, committing itself, through an international treaty such as the one consulted, or through an internal act, to facilitate the rational use of chemically hazardous products subject to international trade is not only possible but entirely in accordance with its constitutional duties. Pesticides and industrial chemical products are substances that can cause damage to human health and the environment. In the face of such a threat, the Rotterdam Convention provides the Parties with the possibility of knowing in advance the composition and effects of certain chemical products, which are expressly indicated in its Annex III. The appropriate measures the State takes to regulate the marketing and use of such products in industrial, agricultural activities, etc., are consistent with its duty to preserve the aforementioned values of constitutional rank. Hence, the duties the State would assume if it definitively approves this Convention are legitimate, in accordance with Constitutional Law. This would be a sovereign decision by the State to submit to the obligations contained in the Convention, in order to contribute to the protection of the health of persons and the integrity of the environment, so it can be concluded that, in general terms, no defects of unconstitutionality are observed in the clauses of the Rotterdam Convention, the approval of which is submitted for consultation.” (resolution number 2008-018207 of 6:15 p.m. on December 10, 2008) Thereby verifying that this Tribunal has recognized the risk that the use of pesticides may entail and the importance of adopting suitable measures to regulate their use. In the Costa Rican legal system, there are diverse legal and regulatory provisions from which it follows that the activity of importing, manufacturing, marketing, and using pesticides is strongly subject to the police power of the State, in order to guarantee the right to health and a healthy and ecologically balanced environment. One may cite, first, the General Health Law, which in its Article 213 provides:

"ARTICLE 213.- Every natural or juridical person engaged in producing food must do so under sanitary environmental conditions and using defense or conservation techniques approved by the health authority, in order to chiefly avoid the contamination of such products and their dangerousness due to the presence of toxic residues from their treatment with pesticides or other defense or conservation systems." Meanwhile, Article 244 of that same normative body establishes:

"ARTICLE 244.- Natural and juridical persons that import, manufacture, handle, store, transport, trade, supply, or apply substances, mixtures of substances, or products denominated pesticides by the plant health law, shall be subject to the regulatory provisions that the Ministry dictates in agreement with the Ministry of Agriculture for the safeguarding of people's health in accordance with that law; those concerned must register any pesticide or product destined for the control or extermination of infestations and request prior permit to operate when such substances, mixtures of substances, or products that by their nature or use are not included in the mentioned law are capable in any way of producing intoxications or serious damage to the health of people or of animals that are useful or harmless to man." For its part, through the Plant Health Protection Law (Law No. 7664 of April 8, 1997), the plant health protection measures established in that law and its regulations were declared of public interest and mandatory application (art. 1). Moreover, among the objectives of said law is included: “To regulate the use and handling of chemical, biological, or related substances and equipment for applying them in agriculture; likewise, their registration, importation, quality, and residues, while at the same time seeking to protect human health and the environment” (Article 2, inc. e). The competent authority on the matter is the State Plant Health Service, which is responsible —among other functions— for: “Controlling the chemical, biological, or related substances for agricultural use, in what pertains to their registration, import, export, quality, tolerance, residues, dosages, effectiveness, toxicity, presentation to the public, conservation, handling, trade, general conditions of use, safety and precautions in transport, storage, disposal of containers and residues of such substances; likewise, controlling the equipment necessary to apply them and any other activity inherent to this matter” (Article 5, inc. o).

(…)

It follows from the previously cited regulations that, as a manifestation of the referred police power, the necessary registration of pesticides is included prior to authorizing their import, manufacture, marketing, or use, in order to be able to exercise prior control regarding the due compliance with the corresponding technical requirements of quality and safety, in protection of public health and the environment." These considerations are applicable in the sub lite, that is, the internal legal system contemplates various regulations and competences in favor of the national technical authorities so that, in use of that police power, they remain vigilant and guarantee the quality and benefit of the pesticide products whose registrations are intended to be updated, and, definitively, that the rights of all persons are thereby safeguarded.

In this respect, as will be seen in detail below, the challenged regulations are not designed for the registration of new pesticide products, but rather to update the registrations of products that are already registered and freely marketed in the domestic market. In the event of the slightest doubt that the duly registered pesticide (whether as IAGT or formulated pesticide) causes harm or a threat to health or the environment, all national authorities, including the Ministry of Health or MINAE, have their own powers and competences to institute the appropriate procedures in order to prevent the import, manufacture, handling, marketing, or use of the product. Furthermore, if necessary, they can issue the precautionary measures that are needed to safeguard the mentioned legal interests. Precisely, the precautionary principle —invoked by the claimant— must inspire all a priori and a posteriori control conduct of all the public authorities mentioned, and, if in any specific case harm or threats to public health or the environment are suspected or evidenced, they are under the constitutional obligation to adopt the corresponding preventive measures.

Echo must be made of what was already indicated in judgment no. 2017-06668, regarding the constitutionality of executive decree no. 39995-MAG, which is also applicable to this decree, since the fact that the Ministers of Health and Environment and Energy did not sign the decree does not imply a defect of unconstitutionality in the questioned regulations because it has been issued jointly by the President of the Republic and the Minister of Agriculture, whereby no affectation of the provisions of art. 146 of the Political Constitution is perceived.

Finally, it is reiterated that, in light of the provisions of art. 10 of the General Law of Public Administration (LGAP) —the administrative norm must be interpreted in the manner that best guarantees the fulfillment of the public purpose to which it is directed—, this special regulation must be applied and interpreted integrally with what is provided in the legal system on the matter (public interest laws mentioned supra). That is, it can in no way be understood that the challenged provisions constitute a normative body isolated from the rest of the block of legality and constitutionality, and that the specific task of updating the information in the registrations implies nullifying the remaining legal competences entrusted to other ministerial portfolios.

By virtue of the foregoing, based on the considerations made, this Chamber fails to prove the alleged injuries to the precautionary principle attributed to the decree, solely because it is signed by MAG and because the registration update competences are concentrated in SFE. As examined, such competences are sovereign powers granted by the legislator itself (art. 59 LGAP), which do not nullify the other legal provisions of public interest on the matter.

VII.- ON THE PROCEDURE REGULATED BY THE CHALLENGED REGULATIONS The claimant insists that the Ministry of Health and MINAE must intervene in these processes, even more so in this case, which is not a simple update, but a scientific analysis of the information presented by the registrant to carry out the respective risk assessment.

On this point, the Minister of Agriculture and Livestock explains that the decree on file updating and its amendment applies exclusively to all registrations of “technical grade active ingredient” (IAGT) and formulated products that were registered under regulations (legal or reglementary) other than executive decree no. 33495-MAG-S-MEIC-MINAET, “Regulations on the Registration, Use and Control of Formulated Synthetic Pesticides, Technical Grade Active Ingredient, Adjuvants and Related Substances for Agricultural Use.” That is, he emphasizes that it only applies to those registration files for products that are already on the market and that were registered in accordance with the regulations applicable at the time of their approval, and which were integrally evaluated (health, environment, and biological efficacy) in accordance with those regulations. He adduces that the plaintiff confuses and intends to confuse regarding the agrochemicals registered and currently marketed in the country, which are those to which executive decree no. 39995-MAG and no. 41481-MAG apply, trying to make it seem that they must be evaluated anew, which is neither appropriate nor necessary, since all products registered in Costa Rica complied with the requirements and regulations established in the positive law in force at the time those registrations were granted. Consequently, he vehemently clarifies that in none of the pesticide products, whether raw materials or formulated products that hold a valid registration, is there evidence or technical scientific presumption, or at least indications, that presume an additional or resulting danger from their application, regarding human health, the environment, or the biological efficacy of the pesticide. Both the Constitutional Chamber and the PGR have been clear in that the Ministry of Health, the Ministry of Environment, the Ministry of Agriculture, and even private individuals, can resort to the ordinary jurisdictional venue to request the annulment of the administrative acts through which those registrations were granted, and they can even request as a precautionary measure that their marketing be suspended. However, neither the Ministry of Health, nor the Ministry of Environment, nor the plaintiff do so because they lack evidence, and scientific and technical support to do so, and, therefore, he understands that the plaintiff recklessly comes before the Constitutional Chamber to raise issues of legality through unconstitutionality actions, the sole aim and objective of which is to hinder the process of organizing the agrochemical registration system undertaken by the Administration.

He insists that with the aforementioned decrees -no. 39995-MAG and no. 41481-MAG- registrations are not being granted for new IAGT or formulated pesticides, but rather they apply only to old IAGT (raw materials) and formulated products. In this regard, he explains that it was starting in 2007 that a registration system was established that requires the prior registration of the raw material —IAGT—. Before that date, it was not necessary to register the IAGT, and it is for this reason that the Executive Branch issued the decrees under challenge. He alleges that it is not as the plaintiff indicates, that through the challenged regulations the registration of new products is being facilitated, for the truth is that nothing is facilitated; rather, a space is opened for registration holders to submit confidential chemical information, which is fundamental to guarantee that there are no significant impurities from a toxicological and ecotoxicological perspective in any of the products currently marketed by virtue of a valid registration, granted for an indefinite period. Therefore, he maintains that it is not correct to affirm that, with the application of these regulations, the registrations updated in their files entail an additional risk to health, the environment, or agriculture, since all IAGT registrations granted must necessarily and inevitably correspond to one of the formulations already sold on the market, and over these formulations the Ministries of Health or Environment have broad and indisputable competences and powers to adopt the pertinent measures in order to prevent harm to health or the environment.

He points out that executive decree no. 39995-MAG and its amendment no. 41481-MAG allow for the resolution of the problems of disorder, uncertainty, and lack of information in the registration files that support the registrations of IAGT and formulated pesticides with valid registration, but which were granted under regulations other than executive decree no. 33495-MAG-S-MINAE-MEIC.

[The appellant] considers that the challenged regulation is a major step forward and resolves a problem that began in 2004 and had not yet been resolved by previous administrations, since it provides for alternatives and ways to resolve the two most serious problems afflicting the registration system of our country: on the one hand, the paralysis in the registration of new and generic products and, on the other, the impossibility of renewing the registrations of formulations currently on the market.

In that sense, he details that the contested regulation allows: a) the updating of manufacturers, their origin, production sites of the Technical Grade Active Ingredients (Ingredientes Activos Grado Técnico, IAGT) associated with formulations already marketed in Costa Rica and that were registered under different legislation; b) the same in relation to formulated pesticides (plaguicidas formulados); c) ending the legal uncertainty regarding the validity of IAGT and formulated pesticide registrations that were registered under previous legislation and regulations, standardizing the validity period to ten years for all registrations and thus eliminating indefinite validity. He explains, consequently, that all the chemical information required to make decisions regarding the product in terms of its safety and efficacy is added to the registration dossier (expediente de registro) required in Article 23 of the Phytosanitary Protection Law (Ley de Protección Fitosanitaria), putting an end to indefinite-term registrations.

When the amparo action (recurso de amparo) No. 17-002503-0007-CO was processed, the then Minister of MAG reported under oath before this Chamber the following:

"regarding the basis that gives rise to the promulgation of Executive Decree (Decreto Ejecutivo) No. 39995-MAG, we find it in the 7 recitals (considerandos), of which the first 6 provide the legal basis, in this case the Phytosanitary Protection Law No. 7664, whose purpose is to regulate the use and handling of chemical, biological, or related substances and equipment for applying them in agriculture; likewise, their registration, importation, quality, and residues, while seeking to protect human health and the environment. All of these must be entered in the registry that the State Phytosanitary Service (Servicio Fitosanitario del Estado) will create to have information on their characteristics and ensure their proper use in the country. Agricultural-use pesticides are fundamental for combating pests that affect agricultural production and for the competitiveness of agricultural producers; therefore, it is essential to guarantee the supply and continuity of marketing of products that currently have a valid registration, making it necessary to update the information in their dossiers on their characteristics and ensure their proper use in the country. It is precisely this recital that summarizes the purpose of the decree under analysis. The decree indicates in its recital 4 that regulations prior to the entry into force of Executive Decree No. 33495 MAG-S-MENAE-ME1C of October 31, 2006, and its amendments, allowed the Ministry of Agriculture and Livestock to grant indefinite-term registrations as well as the registration of formulated pesticides without the requirement of having a prior registration for the technical grade active ingredient (IAGT), which obliges, within the constitutional and legal powers of the Executive Branch, to organize its registry, ordering the updating of information for registrations entered without a term, having been granted under a regulation prior to the one governing the current registration. The appealed decree aims to update the dossiers with information that was not requested at the time of their registration and to have updated information, through a re-registration process in accordance with Constitutional Article 50, such that the State will seek the greatest well-being for all inhabitants of the country, organizing and stimulating production and the most adequate distribution of wealth, guaranteeing a healthy and ecologically balanced environment. The State will guarantee, defend, and preserve that right, which is guaranteed by the decree since, although production is stimulated, that does not preclude protecting the environment and health and life, none of which can be put at risk, which is why the Ministry of Agriculture and Livestock has the legal authority to administer the registry assigned to it by law and for which, at a minimum, it must update the dossiers as part of its internal organization. Registrations granted prior to Executive Decree No. 33495-MAGS- MINAE-MEIC of October 31, 2006, and its amendments, were granted without a term, which obliges the Executive Branch to conduct an analysis of those registrations, requesting from each registrant the information established in the Decree at hand to update the registration and therefore the information, so that registrants can register in accordance with the requirements of current regulations, while guaranteeing the continuity of their marketing, given their importance as a tool for combating agricultural pests and also stimulating the production entrusted by law to the Ministry of Agriculture and Livestock, without detriment to other constitutional guarantees such as life and a healthy environment, provided that production is not harmed as long as it does not affect life. Due to the nature of the issued regulation, this is not a Technical Regulation (Reglamento técnico) but rather an updating of valid registrations, so the technical regulation procedure is not required; however, the regulation was uploaded to the MEIC page, as evidenced in the attached administrative file, filling out the Cost-Benefit Evaluation Form in Section 1, called Prior Control of Regulatory Improvement, which yielded a negative result and was available to the public as it is a freely accessible page. The decree, in summary, provides that holders of registrations of Technical Grade Active Ingredients (IAGT) and formulated products that do not have an IAGT registration, and that were not registered in accordance with Executive Decree No. 33495-MAG-S- MINAE-MEIC of October 31, 2006, and its amendments, must update the manufacturer(s) of their IAGTs, within a period of twenty-four months from the entry into force of this decree; providing the State Phytosanitary Service with the information indicated therein for updating the manufacturer, also referring to the provisions of the Central American Technical Regulation (Reglamento Técnico Centroamericano) No. RTCA 65.05.67.13: Agricultural Inputs. Technical Grade Active Ingredient, Formulated Chemical Pesticides, Mine Substances, Adjuvants, and Physical Vehicles for Agricultural Use. Requirements for the Preparation of Labels and Leaflets. Resolution No. 365-2015 (COMIECO LXXII). In the case of formulated pesticides whose IAGT is not registered, and whose dossier has been updated, the State Phytosanitary Service will grant, within a period not exceeding three months from the date on which the update was approved, the corresponding IAGT registration. The decree expressly establishes that the IAGT registrations granted under the decree may not be used as a reference profile under the equivalence registration modality, unless the complete data package has been provided. Article 7 refers to the legal powers that different laws grant to the Ministry of Health and the Environment, but not to the administration of the registry, which is what the regulation intends, since the power of the Ministries of Health, Environment, and Agriculture to restrict or prohibit a use of a pesticide is independent of the reference decree. Based on the rendered report and the administrative file, as well as the letter of the contested decree, it is understood that the Decree pursues the internal organization of the SFE Registration Office, as a body of minimal deconcentration (órgano de desconcentración mínima) of the Ministry of Agriculture and Livestock. He requests that this amparo action be declared without merit in all its aspects." In this regard, the Chamber considers it necessary to clarify the scope of the regulation contested in action No. 18-019039-0007-CO (regarding Executive Decree No. 39995-MAG) and the one under consideration in this action (regarding Executive Decree No. 41481-MAG).

For the above, it is appropriate to cite the recitals or preamble of both decrees, as they shed important light on the objectives of the rules in question. The "Regulation for the Updating of Information in Registration Dossiers for Technical Grade Active Ingredient and Formulated Pesticides, No. 39995-MAG" starts from the following premises:

"1°-That one of the objectives of the Phytosanitary Protection Law is to regulate the use and handling of chemical, biological, or related substances and equipment for applying them in agriculture; likewise, their registration, importation, quality, and residues, while seeking to protect human health and the environment.

2°-That the Phytosanitary Protection Law expressly establishes that all chemical, biological, or related substances and application equipment for agricultural use must be entered in the registry that the State Phytosanitary Service will create to have information on their characteristics and ensure their proper use in the country.

3°-That agricultural-use pesticides are fundamental for combating pests that affect agricultural production and for the competitiveness of agricultural producers; therefore, it is essential to guarantee the supply and continuity of marketing of products that currently have a valid registration, making it necessary to update the information in their dossiers on their characteristics and ensure their proper use in the country.

4°-That regulations prior to the entry into force of Executive Decree No. 33495 MAG-S-MINAE-MEIC of October 31, 2006, and its amendments, allowed the Ministry of Agriculture and Livestock to grant indefinite-term registrations as well as the registration of formulated pesticides without the requirement of having a prior registration for the technical grade active ingredient (IAGT), so it is necessary to update the information of these registrations and also to establish a validity period equal to that of registrations granted under current regulations.

5°-That international regulations establish toxicological, ecotoxicological, and environmental fate information requirements indicated in Executive Decree No. 33495-MAGS- MINAE-MEIC of October 31, 2006, and its amendments, which were not requested in previous regulations, making it necessary to extend the registrations granted before said executive decree so that they can enter a registration process in accordance with the requirements of current regulations, while guaranteeing the continuity of their marketing, given their importance as a tool for combating agricultural pests.

6°-That both the Food and Agriculture Organization of the United Nations (FAO) and the World Health Organization (WHO) recognize that the repetitive generation of studies and information regarding all potential/actual risks for each manufacturer of a pesticide may be unnecessary and ethically undesirable.

7°-That the Cost-Benefit Evaluation Form was filled out in Section 1, called Prior Control of Regulatory Improvement, yielding a negative result and indicating that the proposal has no procedures or requirements." While the premises of the "Amendment to the Regulation for the Updating of Information in Registration Dossiers for Technical Grade Active Ingredient and Formulated Pesticides", No. 41481 – MAG, are the following:

"CONSIDERING 1.- That by Executive Decree No. 39995-MAG of December 15, 2016, published in Gazette No. 11, Alcance No. of January 16, 2017, the Regulation for the Updating of Information in Registration Dossiers for Technical Grade Active Ingredient and Formulated Pesticides is decreed.

2.- That the State Phytosanitary Service, hereinafter (SFE), upon a consultation from its Internal Audit to the Office of the Attorney General of the Republic (Procuraduría General de la República), suspended the application of Decree 39995-MAG, and currently, due to a lack of procedure, it has not been possible to update the information for any of the registrations of Technical Grade Active Ingredients, hereinafter (IAGT), and formulated products that do not have an IAGT registration and that were not registered in accordance with Executive Decree No. 33495-MAG-SMINAE- MEIC of October 31, 2006, and its amendments.

3.- That the Office of the Attorney General of the Republic, upon the consultation from the SFE Internal Audit, issued opinion No. C-199-2017 of September 8, 2017, concluding regarding Executive Decree 39995-MAG that: 'it concerns a revalidation (reválida) of previous registrations, entered under other regulations, and does not refer to a registration procedure per se. Furthermore, according to the provisions of numeral 6°, it is intended to impose a validity period on these registrations that were previously indefinite.' 'Therefore, it is not apparent from said Decree that it is a technical regulation requiring the consultation procedure before the Technical Regulation Body. On the contrary, it concerns the development of the provisions of Article 23 of the Phytosanitary Protection Law.' 4.- That both national legislation and international regulations establish that confidential information provided by registrants in registration processes and dossier updates, due to its protection regime and commercial sensitivity, must be diligently and appropriately safeguarded by the authorities to guarantee its inviolability and prevent misuse.

5.- That specifications and international standards from first-world countries and regions as well as from internationally renowned organizations are a technical and scientific reference to determine that the technical grade active ingredients synthesized by the manufacturers proposed in the dossier update processes do not contain relevant impurities at levels above international standards or specifications, and relevant impurities are those having toxicological or ecotoxicological relevance, which may cause an impact on health or the environment.

6.- That technical grade active ingredients are used solely for the formulation of synthetic chemical formulated pesticides, and only by exception are they used directly in the field, and these exceptional situations are already regulated in the current technical regulations; therefore, registration certificates for technical grade active ingredients are only useful to authorize, by the State Phytosanitary Service, the importation of these as raw material for pesticide formulations in processing plants and not for their direct use in the field.

7.- That the repeatedly cited Executive Decree 39995-MAG established a period of twenty-four months for updating the Registration, which expires on January 16, 2019, and that currently there is no procedure allowing its application, so it is timely and convenient to establish a new reasonable period for the application of the aforementioned decree and the procedures.

8- That the approval of the Regulatory Improvement Directorate of the Ministry of Economy, Industry, and Commerce is on record, according to Report DMR-DAR-INF-149-18, of December six, two thousand eighteen." (The highlighting does not correspond to the original).

Thus, it is reiterated that the regulation under review applies only to old products, that is, products for which IAGT or formulated registrations have already been granted, and many of those registrations were granted for an indefinite term. This means they do not require the updating decree to continue marketing. Therefore, rather than facilitating matters, it is about imposing an obligation on them to update their information and provide data and studies that certify not only the provenance and origin of the technical materials and associated formulations but also provide confidential chemical information that allows the registration authority, i.e., the SFE, to have available confidential chemical information on the purity, impurities, synthesis method, etc., of their technical materials, regarding both manufacturers and formulators. It is precisely from the detail of the information provided that the registration authority may make regulatory decisions regarding the continuation or not of a registration or of a manufacturer of a technical material for a formulation marketed in Costa Rica. As emphasized supra, failure to undergo this registration update procedure may lead to proceedings in accordance with Article 24 of the Phytosanitary Protection Law. Likewise, with complete registration information, decisions can be made in light of what is expressly regulated by Article 30 of the same law:

"Art. 30.- Prohibitions and restrictions for technical reasons The Ministry of Agriculture and Livestock may restrict or prohibit the importation, transit, redirection, manufacturing, formulation, repackaging, re-wrapping, storage, sale, mixing, and use of chemical, biological, or related substances and application equipment for agricultural use, when justified for technical reasons and it is considered that using them is harmful to agriculture, health, or the environment." It is observed that this police power (poder de policía) empowers the State to evaluate products in light of the updated information and adopt the corresponding decisions in the interest of safeguarding agriculture, health, or the environment.

Now, the grievance of the plaintiff, beyond specifying aspects of the specific procedure, centers on questioning that, in his opinion, the Ministry of Health and MINAE should intervene.

However, as was examined above, the fact that they did not participate in the adoption of the regulation, or in the process of updating the registry information, does not in any way per se imply an injury to the Right of the Constitution.

Now, although it was not detailed by the petitioner in this section, it should be noted that the submission of information from other registration case files (expedientes de registro) was endorsed by the majority of this Court in judgment No. 2022-26651, in light of the international technical legislation that permits it, and for this reason, regarding these aspects, it is necessary to abide by what was stated in the aforementioned decision.

VIII.- CONCERNING ART. 1 OF THE DECREE The petitioner states that the partial reform and addition to the executive decree No. 39995 is a benefit to pesticide marketers, since they extend the time following the publication of the challenged decree, granting a benefit of five more years to those products without them having undergone a risk assessment and granting that additional time so that the registry owners (dueños registrales) can submit the information. Even though a exhaustive list of requirements is defined in this same article, he considers them to be limited for conducting a risk assessment. He assumes that what the ministerial office pursues with the promulgation of this type of document is to demand, order, or intimidate the registry evaluators to limit themselves solely to requesting limited information, which lacks technical and scientific support to carry out a risk assessment according to national and international standards with decimated requirements. He questions whether in the article in question, the MAG again insists on the referenced information process, without proprietary or referenced information, as this regulation proposes. Thus, the Executive Branch and the pesticide industry seek to facilitate the trade of pesticides against human health, animal health, and the environment.

In this regard, the Minister of MAG explains that the challenged article maintains its scope of application in the sense that it cannot be used to register new pesticides and the only thing that changes is related to the deadlines and one of the administrative requirements. Regarding the issue of deadlines, he considers it a matter of legality, since it is up to the competent authority to define what the deadlines are within which certain acts must be performed and the deadlines that the administered party must meet for their procedures under the norm. Furthermore, it is insisted that the powers were delegated by the will of the legislator to the MAG through the SFE. From a technical and scientific point of view, the regulation allows the State to have all the information on purity, relevant impurities (name, content, and detection levels), total impurities, synthesis method, analytical methodologies to determine the IAGT and its relevant impurities, of all the IAGTs registered as such or as components of a formulation, which were registered in Costa Rica with legislation and regulations different from executive decree No. 33495-MAG-S-MEIC-MINAET. The confidential chemical information required by this decree is key and essential, from an agronomic, toxicological, and ecotoxicological point of view, and unfortunately is not incorporated into the case files of these registrations. Much of the chemical information requested in the decree, especially that described in Articles 1 and 5, although it was indeed submitted during the revalidation process, is completely outdated, since between five and ten years have elapsed since the information was provided and the authorities have not yet reviewed, much less approved it. Furthermore, the Costa Rican State is allowed to have updated information on the formulation sites and origins, name and physical location of the formulators, as well as the components of the product and the detailed description of the formulation processes of all formulated products currently marketed in Costa Rica.

From a chemical and scientific point of view, it is guaranteed that no formulated pesticide marketed in Costa Rica can be registered, and therefore marketed, if it does not have an associated IAGT with levels of relevant impurities (which are those of toxicological and ecotoxicological importance) exceeding the levels specified in international reference standards (FAO, EPSA, IUPAC).

The PGR considers that it lacks the competence to rule on the technical aspects and suitability of the requirements demanded to carry out the updating of registrations. However, it does point out that the Chamber must technically assess whether the requirements established by the challenged norm for the revalidation process allow for an adequate assessment of the environmental or health risk of the products, since, from the mere comparison of the texts of decree No. 39995 and decree No. 41841, it is verified that the technical requirements that were contemplated in decree No. 33495 were not added but rather, some points were eliminated and modified. Additionally, it points out that the challenged decree modifies Articles 1.2.b and 6 of decree No. 39995, which allow registering products using referenced information, but maintains that possibility in several provisions and does not establish how the information will be verifiable, how to determine which international specification can be used, the method of determining the equivalence of products, nor whether the reference profile to be used must be a registration that has complete information. By not precisely establishing the rules to which the competent authority must adhere to verify the information, it is possible that the updating of registrations with referenced information that does not comply with the indicated requirements may be permitted, and therefore, subject to what is established in the technical criteria issued, this would imply the updating of product registrations without a prior assessment of the environmental and health risks of their application and the unconstitutionality of the articles that allow the use of referenced information without an adequate determination of equivalence.

In this regard, the Chamber considers that regarding what was reported by the PGR, it is convenient to clarify the argument provided in light of the explanations given by the Minister of MAG. The PGR stated that from the mere comparison of the texts of decree No. 39995 and decree No. 41841, it is verified that the technical requirements contemplated in decree No. 33495 were not added. However, as has been explained, these regulatory instruments regulate different situations, which would justify the requirement of different requirements. Decree No. 33495 regulated all procedures for the registration of new products, while decrees No. 39995 and No. 41841 regulate another different factual situation, because they apply to products that are already registered and in use in the national territory, but for which an update of their registrations must be carried out. This would justify the differential treatment questioned by the PGR.

Now, attending to the petitioner's grievances, it must be indicated that the extension of the deadline is due to a practical situation that was justified in the decree's recitals. This is that the application of the previous decree was suspended by virtue of an administrative decision that paralyzed the procedure that was being carried out:

"That the State Phytosanitary Service (Servicio Fitosanitario del Estado, SFE), following a consultation from its Internal Audit to the Attorney General's Office (Procuraduría General de la República), suspended the application of Decree 39995-MAG and currently, due to lack of procedure, it has not been possible to update the information for any of the registrations of the Technical Grade Active Ingredients (Ingredientes Activos Grado Técnico, IAGT) and formulated products that do not have an IAGT registration and that were not registered in accordance with Executive Decree No. 33495-MAG-SMINAE-MEIC of October 31, 2006, and its amendments." (Emphasis is not from the original.)

The foregoing justifies the claimed extension of the deadline.

Then, the petitioner's argument is reduced to stating that the requirements are limited and that they imply a way of intimidating the registrar so that they do not request more information from the applicants. This argument lacks adequate and reasonable grounding, as it does not detail which requirements are considered insufficient. Moreover, regarding the application, it is nothing more than a mere subjective assessment of a potential consequence of the norm, which has no basis in an objective element inferred from the clause under analysis. Neither does the petitioner's presumption that these norms seek to facilitate the work of traders have such basis, all of which was rejected and justified in the MAG's report. Therefore, this Chamber estimates that these grievances must be dismissed.

Regarding referenced information, this Court, in judgment No. 2022-26651, as has been stated, conducted an analysis of the international technical legislation that allows submitting information from other registration case files (expedientes de registro) and concluded that the possibility of using referenced information from registries of non-national authorities to process registration procedures is not unconstitutional, because it is justified by the international technical and scientific instruments that this judgment takes care to indicate. For which reason, regarding these aspects, it is necessary to abide by what was stated in the aforementioned decision and dismiss the grievances.

IX.- CONCERNING ART. 2 The petitioner accuses that the proposed reform reduces the time for evaluators to make a decision, going from three months defined in executive decree No. 39995 to one month in the modification proposed in decree No. 41481-MAG. He argues that this shows that what is sought in this type of regulation is the benefit of agrochemical selling companies, so that registry analysts carry out the analysis under time pressure, without a workload study having been done to determine the proposed time. He adds that what is most serious is that the analysis proposed in this decree is defined as a simple verification of chemical documents, that is, whether the registrants submitted the information or not, but the degree of lack of coordination is such that this verification of documents of a chemical nature is assigned to agronomy professionals, who do not have the competencies or the training to perform this task. This proposed approach is a new registration method that is only carried out with a simple "check list" or verification list.

The Minister of MAG maintains that in this aspect the petitioner limits himself to objecting to matters of mere legality and is silent regarding the alleged unconstitutionalities of the norm he objects to. He points out that, even from a plain and simple reading of the text, it is manifestly false that the petitioner's statement that registrations are being granted to new products through this regulatory norm is false. He adds that it is also not true, as the petitioner states, that agronomists are in charge of reviewing chemical information; but beyond the inaccuracies and fallacies incurred by the petitioner, it is clear that his arguments are about administrative aspects and matters of mere legality that it is not for the Constitutional Chamber (Sala Constitucional) to resolve, but rather for the ordinary jurisdiction.

The PGR considers that the unconstitutionality of Art. 2 must be declared if, based on the technical criteria that are submitted to the case file, it is determined that the reduction of the deadline from three months to one month, for the SFE to verify and analyze the submitted information and resolve the product update request and grant the registration certificate, prevents an adequate assessment of the environmental and health risk of the product from being carried out. It adds that, without prejudice to what is resolved on that article, it is advisable for the Constitutional Chamber (Sala Constitucional) to clarify whether the rule that the figure of positive silence does not operate in the case of environmental approvals or authorizations is applicable, and that, therefore, the Administration's failure to comply with the established deadline would not imply the automatic approval of the product's revalidation.

The current norm, in comparison with the original decree, establishes the following:

For the Chamber, the arguments of unconstitutionality lack adequate grounding. The mere fact that the resolution deadlines are reduced does not mean that this procedure in itself is less protective or injurious to constitutional provisions. It must be implicitly understood that by virtue of the constitutional principles that must govern the functioning of the entire Public Administration, the authorities of the SFE —as legally designated for the resolution of this type of procedures— must resolve the registration update request efficiently and promptly; but, in the same way, they have the utmost obligation to ensure phytosanitary protection as a matter of public interest.

It is also worth highlighting that many of the grievances raised by the petitioner are based on a generic premise that the requirements are not sufficient and that the means are being facilitated so that, in their application (reduction of deadlines and competent authority), the traders of these products are favored. In this regard, this court observes that there is no appropriate grounding on the issue of requirements (which ones are enough and which ones are not) and the petitioner does not refer to the potential way in which the Administration (SFE) will exercise its powers. This, moreover, would not be the object of an unconstitutionality action, but rather of a control that must be carried out by the entire Public Administration and the ordinary jurisdiction, so that the legally assigned powers are exercised rigorously and efficiently.

There is also no evidence in the questioned norm that this evaluation is carried out by agronomy professionals and that they lack the competencies or necessary expertise to make an appropriate assessment of the submitted documentation, always safeguarding the environment and people's health.

Regarding what was stated by the PGR, this Chamber considers that its presumptions also start from a mistaken premise, because it refers to "granting the registration certificate"; however, as has been explained, the norm in question does not properly regulate the registration of products, since they are already on the market, but rather what is required is the updating of all the information in their registrations. Now, concerning the request for clarification made by the PGR, this Court estimates that it is clear that for everything related to registration —which is not the case of the norm under analysis— or to the updating of information in the registries, the institution of positive silence is not applicable. In our legislation, the application of positive silence has been permitted —from the moment the application with its formal requirements has been submitted, before the competent body and in the manner required by law— only for those procedures of the administered party that are related to licenses, permits, authorizations, or when a specific norm explicitly authorizes it. The purpose of this legal figure is to provide the administered party with a regulated and expeditious way to resolve their requests when, for one reason or another, the Administration has delayed in providing legal certainty on what was requested. However, for a long time, this Court has been emphatic in pointing out that in environmental matters —not only for the protection of the environment itself, but also for the impact it has on people's health— positive silence does not operate. For example, since judgment No. 1994-6332, the following has been considered:

"The point under discussion in this amparo appeal is the applicability or not of the legal figure of positive silence with respect to the license or authorization requested —by the appellant— for the scientific collection of scarlet macaws (lapas rojas). In this regard, this constitutional body has maintained that in general terms, positive silence operates in the face of the Administration's inertia and in those cases where the petitioner has complied with all the requirements for its granting; the truth is that the protection and preservation of the integrity of the natural environment is a fundamental right, so it cannot be understood that positive silence proceeds simply due to the passage of the deadline within which the Administration should have ruled on the permit for obtaining wild individuals of 'Ara Macao' for scientific conservation purposes in the Central Pacific region. Hence, the Pro Iguana Verde Foundation cannot derive subjective rights in application of the aforementioned legal institution, since the public interest represented by the State regarding its obligation to guarantee the right that assists every person to enjoy a healthy and ecologically balanced environment prevails over the private interest of wildlife exploitation." (Criterion reiterated in judgments numbers 1999-01149, 2000-01375, and 2006-14479).

Such considerations were replicated by this Chamber in judgment No. 2016-017375, which concluded the following: "it has also been clearly stated that in this environmental matter, the figure of positive silence does not operate." In the matter of drug registration —which clearly has an impact on people's health—, the Chamber has also warned of the inapplicability of positive silence. The following reflections were expressed in judgment No. 2006-000688:

"The importance that this precious right holds, as well as the Administration's duty granted at the constitutional level to ensure its protection, allows concluding that it would be contrary to the Social State of Law advocated by our Magna Carta to allow the application of the concept of positive silence in the matter of drug registration. This Constitutional Court (Tribunal Constitucional) considers that the aforementioned drug registration procedure carried out by the Ministry of Health requires meticulous technical analysis that allows concluding with certainty whether the product in question does not represent a danger to the health of the country's inhabitants; for which reason, it is indispensable that said process be carried out efficiently." In response to the foregoing, this Chamber considers it necessary to clarify that the concept of administrative approval by silence (silencio positivo), especially in cases such as this one, can in no way be conceived as the mere passage of the deadline within which the Administration should have issued a ruling on a matter; this is because the protection of the right to health is at stake (in this regard, see resolution No. 1999-1149 of 7:33 p.m. on February 17, 1999).” The jurisprudential guidelines of this Chamber in environmental matters were incorporated into the Forestry Law (Ley Forestal) No. 7575 of April 16, 1996, which states the following:

“Art. 4.- Administrative approval by silence (Silencio positivo) In matters of natural resources, administrative approval by silence (silencio positivo), as contemplated in articles 330 and 331 of the General Law of Public Administration, shall not operate.

When the State Forestry Administration does not resolve matters submitted for its consideration within the timeframes stipulated in the General Law of Public Administration, the responsible official shall be subject to the sanctions set forth in the laws.” (Thus amended by Article 1 of Law No. 10072 of November 18, 2021. The highlighting does not correspond to the original).

Likewise, they were incorporated into the recent reform made to the Law for the Protection of Citizens from Excessive Requirements and Administrative Procedures No. 8220, which, in the relevant part, warns the following:

“Excepted from the application of administrative approval by silence (silencio positivo) are licenses, permits, and authorizations in matters of public health and the environment, and those matters in which, by constitutional provision, law, or judicial jurisprudence, it is expressly so indicated. Each institution must expressly indicate, in the National Catalog of Procedures, for which specific cases this figure is not applicable, under penalty of incurring an administrative fault by the Procedure Simplification officer.” (The highlighting does not correspond to the original).

Therefore, in light of the reiterated jurisprudence of this Chamber and the current legal provisions, it is understood that with regard to procedures related to the registration or updating of pesticides, due to their clear impact on the environment and people's health, the administrative concept of approval by silence (silencio positivo) does not apply.

Finally, it should be emphasized that if the trading parties do not comply with this requirement update procedure within the established timeframes, the Administration is authorized to apply the legal provisions on the matter and may cancel the registration (art. 24), and the person is subject to the corresponding fines (art. 76, both of the Phytosanitary Protection Law).

Appeal8345.- REGARDING ART. 3 The plaintiff states that, once again, the ministerial office shortens the time established in executive decree No. 39995 for the benefit of users, without it being known whether there is a technical workload study supporting the decision to change from three months to ten days for the technical evaluation by SFE officials, since this decree unilaterally exempts the corresponding ministries from participation in health and environmental matters.

It specifically questions the paragraph stating that “for formulated pesticides that do not have a registration of a technical grade active ingredient associated with that formulation, and whose manufacturer of that formulated product has been updated in accordance with this regulation, the SFE will grant the certificate of registration of the technical grade active ingredient.” It considers that this decree opposes any active scientific technical principle governing registration matters, as it is granting a registration without even mediating a basic process that governs registration regulations, which is chemical evidence.

Regarding this article, the Minister of MAG reiterates his technical explanation about the purpose of this regulation:

“As we had already pointed out, in Costa Rica before January 10, 2007, the registration system established that a formulation could be registered without needing to have a registration of the raw material, that is, of its technical grade active ingredient (IAGT). After that date, it was established that every formulation, prior to being registered, required the registration of its IAGT. This means that currently, an enormous number—around fifteen hundred—of formulated products are not associated with a manufacturer. That is why Executive Decree No. 39995-MAG of December 15, 2016, and its amendment (Executive Decree No. 41481-MAG of December 10, 2018, published on January 11, 2019, scope number 8 of the Official Gazette La Gaceta), establish an update process that will allow the registration system to guarantee that every formulation marketed in the country will be associated with an IAGT manufacturer. In this way, this update of the manufacturer does not imply that a registration is being granted to a new product. Rather, through this update process, the authority will have the necessary information to determine whether the technical material with which that formulated product is made does not contain relevant impurities and also complies with the international specification that every IAGT must meet for the formulation of pesticides. Therefore, what the plaintiff indicates regarding the lack of technical or scientific basis and the confusion with registration under the equivalence modality is incorrect, because the process proposes not an equivalence but an update of the information of a current registration of a formulated product that does not have an IAGT manufacturer associated with its registration. Let it be remembered that, by virtue of Article 3, it is not that a new product is being authorized, but rather a manufacturer is being associated with that formulation that already has a registration and is marketed in the country.” Furthermore, it refers to the fact that the questions regarding aspects of timeframes and workloads are discussions of mere legality and not of constitutionality.

The provision in question, comparatively with the previous one, stipulates the following:

In relation to the grievances raised, the Chamber observes that the arguments regarding the definition of timeframes and the workloads of the SFE, and the exception of the participation of the Ministries of Health and Environment and Energy, have already been addressed in the preceding sections. The mere circumstance that resolution timeframes are reduced does not in itself imply a violation of Constitutional Law, and the fact that the competencies for updating registrations are concentrated in the SFE is a consequence of a legal provision (art. 23 of the Law of the State Phytosanitary Service), which does not in itself show signs of unconstitutionality, nor has it been challenged.

Regarding the registration, the minister's explanations must be revisited, in the sense that this procedure does not strictly imply granting a new registration, but rather updating all the missing information of the product, and that this allows the authorities to determine whether it contains relevant impurities that warrant some kind of reconsideration of the registration. As has been insisted upon, the procedure regulated by the provision under examination is for products that are already registered and on the market (an administrative authorization already exists), such that information is requested for the purpose of its re-evaluation. Furthermore, as seen in the reports transcribed in this judgment, previously, the validity of registrations was provided for indefinitely, whereas with the provision under analysis, limits and bounds are introduced to that registration.

XI.- REGARDING ART. 4 (which amends art. 5 of decree No. 39995) The plaintiff insists that the registration facilitation process established by executive decree No. 414131 goes against the State's duty to protect all of Costa Rican society. He believes that requirements are merely listed to get by, and that they will not support any information for conducting a technical-scientific risk analysis evaluation.

The Minister of MAG explains that when analyzing art. 5, the plaintiff confuses the concept of manufacturer with that of formulator, such that all the hypotheses, objections, and analyses made of said provision are not applicable to the legal situation governing the update of formulators under executive decree No. 39995-MAG of December 15, 2016, and its amendment No. 41481-MAG.

The provision in question, comparatively with the previous one, stipulates the following:

In the judgment of the Chamber, the plaintiff does not adequately substantiate the reasons why he considers that the requirements demanded therein "will not support any information for conducting a technical-scientific risk analysis evaluation." This is a generic argument, and therefore, this Court cannot conduct a rigorous constitutional review in this regard.

Furthermore, it is necessary to reiterate the criterion of this Chamber in judgment No. 2009-008917, which established the following:

“First, the plaintiffs request that the unconstitutionality of Articles 1, 7, and 8 of Law Number 8702, called Processing of Agrochemical Registration Applications, be declared, arguing that the law does not require a series of essential technical requirements that, in their judgment, must be required in order to register an agrochemical, and that these omissions violate the fundamental rights to health and to a healthy and ecologically balanced environment. In this regard, it should be mentioned that although this Constitutional Court is empowered to act as a negative legislator, with the power to annul from the legal system all those provisions it deems unconstitutional, the truth is that it is prevented from acting as a positive legislator that creates norms. On the other hand, even though this Chamber is competent to hear legislative omissions as established in Article 73 of the Law of Constitutional Jurisdiction, it is important to clarify that not every normative omission can be challenged through this route. In that sense, only those omissions that occur as a consequence of an express and direct mandate contained in constitutional law can be subject to constitutional review through this action.” Now, in the specific case, the omissions challenged by the claimants do not stem from an express mandate of the constituent power; rather, they are omissions that the claimants say they find in the text of the law, without the duty to legislate in the sense explained by the plaintiffs arising from the Political Constitution. Likewise, as this is a Court that acts as a negative legislator, it is clear that a potential upholding judgment, with the consequent elimination of the provision, would not remedy the omissions indicated by the claimants, meaning the action filed in those terms lacks utility and is therefore manifestly inadmissible. Furthermore, it is observed that, at heart, what the claimants are seeking is for this Chamber to determine whether the requirements that the regulations demand for the registration of an agrochemical are technically and scientifically appropriate or not and, should they not be, to rule on the list of requirements that, in their judgment, the regulations should contain. However, it is necessary to indicate that this Court is not the competent body to exercise that function, as that is a competence assigned to the legislator, who, in the exercise of their discretionary powers, is responsible for designing the legal procedures and requirements that must be met for the registration of agrochemicals in the country. Only in those cases where the legislator exceeds that discretionary power to the direct detriment of people's fundamental rights can this Chamber validly hear and rule on the matter. However, since in this case what is challenged is not the text of the regulations themselves or the legislator's discretion, but rather what, in the opinion of the plaintiffs, the law omits, this Court cannot rule with the aim of supplanting competencies and establishing those requirements. Under such circumstances, the action is inadmissible." (The highlighting does not correspond to the original).

This ratio must be replicated in the specific case insofar as, as noted, there is no precision in the claimant's grounds, and the Chamber cannot arrogate to itself the power to make technical and scientific determinations regarding whether or not the requirements demanded in the numeral in question are sufficient to fulfill the legislator's mandate and the constitutional mandates derived from Articles 21, 46, and 50 of the Constitution.

XII.- REGARDING ART. 5 (which reforms art. 6 of Decree No. 39995) The claimant asserts that the chemical equivalence process proposed in this article contravenes international standards, Constitutional Chamber ruling No. 2011-016937, and the reports of the CGR. They argue that no procedure for the evaluation of equivalence in formulated products has been proposed by these institutions. Furthermore, they question that the database does not constitute a solution.

The Minister of MAG responded to these grievances by explaining that art. 6 of the challenged decree guarantees, in its current wording, first, that Costa Rica will cease to have indefinite-term registrations, because following the update, all TGAIs and formulated product registrations will have a validity of ten years, imposing the obligation to renew them, unlike now where, being indefinite-term, they need not be renewed because they have no expiration date; second, that all formulations sold on the market today will have an associated manufacturer, unlike now where the sites and origins of manufacture of the raw materials are unknown; third, that every TGAI used in Costa Rica for the formulation of products authorized for marketing in Costa Rica has its purity accredited and does not have relevant impurities above the international specification; fourth, that all TGAIs used in Costa Rica comply with the international conventions signed by Costa Rica (Annex III of the Rotterdam Convention, the Stockholm Convention, or the Montreal Protocol); and fifth, that the SFE will create a database of toxicological, ecotoxicological, and environmental fate information for the registered technical grade active ingredients that do not have current data protection periods. They state that it is very important for the SFE to have an information bank for molecules that are not new and whose test data are free for use because they lack current protection periods. Furthermore, it is necessary for companies that have toxicological, ecotoxicological, and environmental fate information for technical grade active ingredients that are not new to provide information they have managed to compile, which will serve so that in the future the SFE can gradually build a complete toxicological, ecotoxicological, and environmental fate and behavior profile, which will allow for a reference profile for registrations by equivalence.

In this regard, the PGR held that by not precisely establishing the rules to which the competent authority must adhere to verify the information, it is possible that the updating of registrations with referenced information that does not meet the indicated requirements will be permitted, and, therefore, this would entail the updating of product registrations without a prior evaluation of the environmental and health risks of their application. If the foregoing is verified, according to the technical criteria issued to that effect, this would imply the unconstitutionality of the articles that permit the use of referenced information without an adequate determination of equivalence.

The provision in question, comparatively with the previous one, provides as follows:

In relation to the claimant's arguments, this Chamber considers them to be omitted and confusing and that it is not proper to supplement the argumentation that it would be incumbent upon the claimant to make. This Court has already noted the following:

"The Chamber could not, for example, engage in judicial activism or substitute the claimant in their duty to argue. For this reason, also, the judgment must be '… consistent with what is sought …' in the filing brief." (Ruling No. 2022-026592).

In the case at bar, the claimant indicates that there is no procedure for the evaluation of equivalence; however, they omit to specify which instruments require that, additionally, the authorities must detail a procedure for the evaluation of equivalence, thus preventing this Chamber from conducting a rigorous analysis of the matter. In any case, this mechanism of using reference profiles was examined in another action that was dismissed in ruling No. 2022-26651. It was also extensively assessed in ruling No. 2022-023238, in which it was explained that it is not an automatic procedure, but rather requires adequate analysis and substantiation, which must be controlled in each specific case. Consequently, this Chamber refers to the considerations made in those resolutions.

Moreover, it is noted that the provision under analysis also requires that, in the absence of the equivalence report, it be verified that the TGAI does not contain relevant impurities at levels higher than international standards or specifications, as well as that the technical grade active ingredient is not included in Annex III of the Rotterdam Convention, the Stockholm Convention, or the Montreal Protocol. Therefore, standards for carrying out the analysis in question are expressly established. The authorities of the SFE, as has been noted, must be diligent and demanding in the matter, given that people's health and a healthy and ecologically balanced environment are at stake. For this reason, in the registration and information update process, said authorities are obliged to apply the highest standards of protection to these fundamental rights and to be respectful of the precautionary principle. Likewise, they are under the obligation to update themselves and to progressively adjust to technical developments or international standards in phytosanitary protection. Indeed, as was already noted supra and it is appropriate to insist, this Chamber draws attention to note that – at the slightest trace of doubt – they must require all pertinent documentation or studies, with the purpose of verifying that the product for which the registration is to be updated meets the parameters and conditions necessary to safeguard human health and food safety. Likewise, it is required of them to ensure that its use is appropriate and has the desired effects. Rigor in the selection of studies is as important as the subsequent controls that can be carried out in the application and use of the products.

Consequently, from what the claimant has pointed out, no injury to the Constitution is demonstrated.

XIII.- REGARDING ART. 6 (which reforms art. 7 of Decree No. 39995) The claimant accuses that this article contains an unscientific registration proposal, which departs from national and international standards, and could be unconstitutional as it violates the precautionary principle. They argue that the Executive Branch promulgated this decree which, in congruence with its objective, should have been titled "regulations for registration facilitation," where the priority is the updating or renewal of registration with referenced information, pressuring registration analysts by shortening response times, proposing the registration process with only a simple verification of information, and separating the Ministries of Health and Environment in their registration analysis.

The Minister of MAG states that the current text bears no relation or congruence with the reckless comments and assertions the claimant makes about this specific article. Regarding the assertion that this provision inverts the principle of the burden of proof or the precautionary principle, they reject it "absolutely and categorically," not only because it is a matter of legality to be discussed in ordinary jurisdiction, but because the current text of art. 7 is supported by reiterated opinions of the PGR and rulings of the Constitutional Chamber. They reiterate that it is incorrect and reckless to indicate, as the claimant does, that the questioned decree transgresses the precautionary principle in environmental matters, just as it is also incorrect to state, as the claimant does in this fact and in their arguments, that the burden of proof is inverted.

They point out that the provision subject to action does not permit or make it possible to grant registrations for new products to those already marketed, because its scope of application is very clear and it is only feasible to apply it to current registrations that were granted under regulations (legal or regulatory) different from Executive Decree No. 3495-MAG-SMINAE-MEIC and its reforms. They add that with these regulations, registrations will not be granted for TGAIs, and much less for formulations that are not already on the market. Regarding the agrochemicals registered and currently marketed in the country, there is no additional danger resulting from their application with respect to human health, the environment, or the biological efficacy of the pesticide. Therefore, it is not correct to maintain that, with the application of the decree, the registrations updated in their dossiers pose an additional risk to health, the environment, or agriculture, for all, absolutely all TGAI registrations granted must necessarily and inevitably correspond to one of the formulations already sold on the market, and regarding these formulations, the Ministries of Health or Environment have broad and indisputable competencies and powers to adopt the pertinent measures to prevent harm to health or the environment.

The PGR reiterates that this does not nullify the constitutional duty that, by virtue of the precautionary principle, the competent authorities have to apply the powers provided in Arts. 25 and 30 of the Phytosanitary Protection Law and Art. 5 of the Law for the Import and Quality Control of Agrochemicals, to "deny, suspend or cancel the registration of chemical, biological or related substances," "restrict or prohibit the import, transit, redestination, manufacture, formulation, refilling, repackaging, storage, sale, mixing, and use of chemical, biological or related substances and application equipment for agricultural use, when justified for technical reasons" and "prohibit the circulation or order the destruction of products that do not comply with quality standards, as well as take other measures aimed at improving the quality of agrochemicals." The provision in question, comparatively with the previous one, provides as follows:

In the opinion of the Chamber, contrary to what is stated by the claimant — which is in reality a reiteration of the previous defects already examined — the provision in question authorizes the SFE to initiate the corresponding administrative procedures for the cancellation of the registration — it should be remembered that these regulations apply to products already in use on the market — and, furthermore, reiterates the possibility of exercising the competencies legally granted in the matter. The fact that the reform of the decree in question does not expressly cite the "competent ministries," but rather centralizes the oversight competence, as established in the law, in no way means that other competencies legally granted to other ministries, which would authorize them to adopt administrative measures in order to safeguard human health or the environment, are being disregarded.

It should be remembered that the management of registration is the competence of the SFE, so it is logical that this authority is the one in charge of initiating the corresponding procedure for the cancellation of the registration. In this regard, it is necessary to insist upon the legal power provided for in Art. 30 of the Phytosanitary Protection Law, which precisely entrusts the MAG with the decision to restrict or prohibit the import, transit, redestination, manufacture, formulation, refilling, repackaging, storage, sale, mixing, and use of chemical, biological or related substances and application equipment for agricultural use, when justified for technical reasons and it is considered that their use is harmful to agriculture, health, or the environment. Thus, the challenged regulatory provision reflects that police power provided for the MAG.

However, nothing stated in the challenged numeral renders ineffective other legal competencies that, as noted supra, are of public order and could, for example, urge the MAG or present the corresponding evidence so that the SFE initiates the procedure that concerns it. It should be remembered, as already noted supra, that phytosanitary protection measures are rooted in our Social State of Law, as they seek to protect health (Art. 21), the protection of consumer rights, specifically to health and the environment (Art. 46), as well as the stimulation of agricultural production, so important for our country, in parallel with the protection of the environment (Art. 50).

Therefore, the authorities must carry out oversight jointly.

For example, the General Health Law contains the following powers in favor of the Ministry of Health:

“Art.- 213.- Every person, natural or juridical, engaged in producing food, must do so under sanitary environmental conditions and using defense or preservation techniques approved by the health authority, in order to principally avoid the contamination of such products and their dangerousness due to the presence of toxic residues from their treatment with pesticides or other defense or preservation systems.” Art.- 244.- Natural and juridical persons who import, manufacture, handle, store, transport, trade, supply, or apply substances, mixtures of substances, or products denominated pesticides by the plant health law, shall be subject to the regulatory provisions that the Ministry dictates in common agreement with the Ministry of Agriculture for the safeguarding of people's health in accordance with that law; the interested parties must register every pesticide or product destined for the control or extermination of infestations and request prior permission to operate when such substances, mixtures of substances, or products that by their nature or use are not included in the aforementioned law are capable in some way of producing poisonings or serious damage to the health of people or of animals useful or harmless to man.

Art. 245.- Natural or juridical persons engaged in pest control may operate only with permission from the Ministry using the substances, mixtures of substances, products, and mixtures of products authorized by the Ministry and subject to the originating technical standards, in order to avoid accidents or damage to the health of the persons performing such tasks or to third parties.” (The highlighting does not correspond to the original).

Likewise, the Organic Law of the Environment provides the following:

“Article 59.- Environmental pollution. Pollution is understood as any alteration or modification of the environment that may harm human health, threaten natural resources, or affect the general environment of the Nation. The discharge and emission of pollutants shall be mandatorily adjusted to the technical regulations that are issued. The State shall adopt the measures that are necessary to prevent or correct environmental pollution.

Article 60.- Prevention and control of pollution. To prevent and control environmental pollution, the State, the municipalities, and the other public institutions shall give priority, among others, to the establishment and operation of adequate services in fundamental areas for environmental health, such as:

• a)The supply of water for human consumption.
• b)The sanitary disposal of excreta, wastewater, and stormwater.
• c)The collection and management of waste.
• d)The control of atmospheric pollution.
• e)The control of noise pollution.
• f)The control of chemical and radioactive substances.

These services shall be provided in the manner that the specific laws and regulations determine, seeking the participation of the population and its organizations.

Article 61.- Environmental contingencies. The competent authority shall dictate the necessary preventive and corrective measures when contingencies occur due to environmental pollution and others that are not contemplated in this law.” (The highlighting does not correspond to the law).

In this way, it is appropriate to note that the fact that the challenged decree concentrates certain registration functions in the MAG and specifically in the SFE, does not ignore or render without effect other types of powers and legal authorizations provided in favor of the Ministry of Health and the MINAE regarding the safeguarding of public health and the environment. It was previously noted that the decree under examination cannot be understood as a normative body isolated from the rest of the block of legality and constitutionality, and that the specific task of updating registration information and its review does not entail rendering without effect the other legal powers entrusted to other ministerial portfolios.

Likewise, it is not superfluous to reiterate what was indicated in the precedent transcribed supra No. 2017-06668 in the sense that to nullify a previously processed registration, the demonstration of an unacceptable risk to human health, the environment, or agriculture is indeed required, and it contemplates a power of imperium of the public administration, such as the restriction or prohibition of the use of a registration, even if a prior substantial legal situation exists in favor of the administered party, such as the registration. To that extent, the granted registration can be modified if there is evidence of an unacceptable risk, in which case, the Administration—understood in a broad sense—would be enabled to exercise its powers of imperium and impose precautionary measures.

Therefore, an injury to the invoked precautionary principle is dismissed, and the grievance in question is rejected.

XIV.- REGARDING ART. 9 (which reforms and adds a new art. 11 to decree No. 39995).

The plaintiff accuses that, continuing with the registration facilitation process and without any analysis responding to a technical and scientific basis in accordance with national and international standards, the Executive Branch intends to homologate the uses of one product with another that has similarity in the active ingredient, concentration, and formulation, when in this particular case the minimum that can be done is the chemical equivalence of the active ingredient, but since it refers to a formulation, the co-formulants must be analyzed, which must be declared and a risk analysis must be carried out by the ministries of health and environment, and a biological efficacy study must be presented, respecting the univocal rules of science and technique.

The Minister of MAG states that the plaintiff association contributes nothing more than a transcription of parts of a CGR report that is absolutely decontextualized and not applicable to the specific situation. He indicates that the homologation of formulations proposed in art. 11 of the challenged decree is based on the FAO and WHO specification manual for the preparation of pesticide specifications.

The challenged rule establishes the following:

Article 9.- A new article 11 is reformed and added, and the numbering of subsequent articles is run:

‘ARTICLE 11. Within a period of thirty-six months, counted from the effective date of this reform, the holders of registrations of formulations with a valid registration may request from the State Phytosanitary Service the homologation of the label and pamphlet, with respect to other already registered formulations of the same type, with the same IAGT and equal concentration, in aspects related to authorized uses, pests, approved crops, doses, modes of application, application ranges, and application intervals.

The State Phytosanitary Service, through the agronomic evaluation area of the Registration Unit, within a period of thirty days shall make an assessment of each specific case and verify that the value of the physicochemical properties of the formulated product complies with the parameters established in the technical regulations in force in the country or with that of FAO or other international reference organizations to those presented by the already registered material. The resolution approving or denying the request shall be issued within a period of thirty days counted from the presentation of the agronomic evaluation report. Together with the homologation request, the chemical physical properties of the formulation, the pamphlet, and the label incorporating the requested changes must be provided.” In the Chamber's opinion, the deficiency in the argument is that the plaintiff again intends for this Court to technically determine how to carry out the procedure to evaluate the products with respect to other already registered formulations of the same type with the same IAGT and equal concentration. This corresponds to an entirely technical decision over which this Court lacks competence to make a determination. It appears, without a doubt, to be a discussion of legality and not of constitutionality. Note that it concerns the homologation of labels and pamphlets for products that have notable similarities, so it does not seem reasonable to request, as the plaintiff claims without greater substantiation, a chemical equivalence study. Consequently, the grievance must be dismissed, without prejudice that this can be discussed more fully in the ordinary channels of legality.

XV.- CONCLUSION As a corollary of the considerations made, it is imperative to declare the presented unconstitutionality action without merit.

Magistrates Cruz Castro and Rueda Leal dissent and declare the action with merit for violation of the right to a healthy and ecologically balanced environment. Magistrates Cruz Castro and Rueda Leal will file separate notes. (...)” Res. No. Telf5455 Dissenting vote of Magistrates Cruz Castro and Rueda Leal, with the latter writing. With the customary respect, we dissent and declare the action with merit, for the following reasons.

As a starting point, we reiterate the criterion we expressed in judgment No. 2022-026651 of 4:30 p.m. on November 9, 2022, whose considerations are, to a large extent, applicable to the sub lite:

“1.- Regarding the referenced use of data for registration. The majority turns to the ‘International Code of Conduct on the Distribution and Use of Pesticides. Guidelines for the Registration of Pesticides’ (April 2010) to establish the ‘acceptability of registrations, harmonized and clear, the use of available information and mutual acceptance of data, the existence of mechanisms for the exchange of information between competent authorities’ as a ‘core’ element in that technical regulation and to allege the existence of the ‘principle of non-repetition of studies’. In that sense, it transcribes point 3 of the cited code:

‘3. The principles of pesticide registration The responsible authorities, when managing their national or regional registration programs, should follow a series of important principles that are practiced internationally. The acceptance and use of these principles will ensure greater efficiency, transparency, and optimal use of resources during the registration process. These principles include the following:

Complete criteria and requirements for registration, harmonized and clear; Use of all available information and mutual acceptance of data; Transparency and exchanges of information; Evaluation made on scientific bases to determine if precautionary measures are required; Consideration of hazards; Risk assessment and mitigation based on the local situation; Risk/benefit analysis, taking into account available alternatives; Post-registration monitoring and evaluation; Mechanisms for periodic and unscheduled reviews in order to respond to new information that may have an impact on the regulatory status; Protection of the intellectual property rights of the application.

The evaluation of data retained in the registration dossier should respect internationally accepted and agreed standards and procedures, to the extent they are available. These standards should be updated regularly to ensure their conformity with current scientific advances.

It is essential that all steps of the registration process are transparent, based on well-reasoned and published criteria and guidance documents, with complete information shared with the applicant on the outcome of the different steps of the registration process. The responsible authorities should ensure that the criteria and requirements for registration are complete and clearly defined. The same applies to data acceptance standards, for data quality, for the acceptability of formulated pesticide products for specific users and uses, or for degradability or accumulation criteria.

Governments should facilitate the exchange of information between responsible authorities through national institutions, international, regional, and sub-regional organizations, as well as public sector groups. They should develop legislation and regulations to allow the exchange of information with the public about the risks and benefits of pesticides and also to facilitate public participation in the management of pesticides in the country.

The responsible authorities should, whenever possible, use data that has been placed in the public domain, and preferably those that have been previously reviewed, when considering a registration application. In this way, duplicate work and inefficient use can be minimized. The mutual acceptance of data by various regulatory authorities on topics such as efficacy and residues, among others, is recommended, provided that a solid basis can be established to ensure that the data are relevant in relation to the situation being considered.’ The majority’s citation stopped there. We consider that an adequate assessment of the case requires, at least, the transcription of the two following paragraphs of that same numeral:

‘Furthermore, hazard assessments are generally applicable globally and are available from published sources, including the peer assessments of the Joint FAO/WHO Meeting on Pesticide Residues (JMPR). These can be used in the evaluation of a dossier, provided that data ownership is taken into account appropriately.

Countries should fully evaluate the efficacy, behavior, final fate, hazard, and risk of pesticides in relation to the various anticipated conditions of use in their country. Any registration procedure should include an assessment of the potential risks related to the pesticide use for which the pesticide has been requested. The use instructions, as indicated on the label, should cover these risks and prescribe the measures for their proper application, storage, handling, and disposal to mitigate said risks. In doing so, the responsible authorities should also ensure that these measures can be realistically adopted by the user for whom the product has been intended. The specific requirements under national policies for Integrated Pest Management (IPM) [5] and Integrated Vector Management (IVM) [6] should also be considered.’ (The underlining is added).

Based on the foregoing, contrary to what the majority judgment concludes, we estimate that the full evaluation of the pesticide must be the rule. Our reading of that ordinal is that the mutual acceptance of data is a recommendation (the regulation textually states ‘The mutual acceptance of data… is recommended’) with the purpose of avoiding excessive procedures, such as duplicated work. However, the recognition of referenced information can never substitute the full assessment of the pesticide.

The optional nature of the mutual acceptance of data is also derived from numeral 12 of the cited code, which subjects such acceptance to the pertinence and quality of the data:

‘Mutual acceptance of data. If pertinent data of good quality have been generated in other countries, the responsible authority could obviate the requirement for generating local data. This is especially important for efficacy tests, residue data, and environmental field studies, all of which probably require the involvement of national (public) research institutions;’ Such pertinence and quality, or equivalence conditions, are missing from the challenged decree.

The opposition of the undersigned to the use of referenced information, in the terms of the challenged regulation, was shared by the then Minister of Environment and Energy, who expressed himself in this process in the following terms:

‘This section intends that those IAGTs that do not have their own information (the generics) be updated, and subsequently registered, with the presentation of referenced information. This procedure contradicts the definition of referenced information established in Executive Decree No. 40059-MAG-MINAE-S, which indicates “4.32. referenced information: For the application and interpretation of this regulation, it is the technical information of the reference profile, which may be used by the AC to evaluate the request for a registration of IAGT by equivalence and that does not have a valid protection period.” In turn, the definition of reference profile indicates: “4.49. Reference profile or source: It is the information on which the risk analysis was based and for which a regulatory decision was made and the corresponding registration was granted, and which will be used as a basis for equivalence registration, in accordance with what this regulation establishes.” The comprehensive reading of these two definitions demonstrates that equivalence cannot be determined if one does not have the duly evaluated and registered reference profile, on which the referenced information is based. This procedure does not apply, according to what DE 39995 cited contemplates, which contradicts the CGR's provisions.’ The Comptroller General of the Republic (CGR), in its report FOE-AM-19/2004, pointed out the SFE's non-compliance with national and international regulations by tolerating that registrants submit information from other products (referenced information), without performing an equivalence analysis to verify whether such information is applicable to the new substance to be registered. Based on its analysis, the CGR ordered: "To immediately suspend the practice of registering agricultural pesticides using information corresponding to another previously registered product, without having performed an equivalence analysis in accordance with the provisions that the FAO and the WHO ...". Likewise, the Constitutional Chamber, in its Resolution No. 201101 6937, ordered the annulment of subsection b, and the reference in the penultimate paragraph to said subsection "b)" of section 7.3.2, of Article 2, of DE 33495-MAG-S-MINAE-MEIC, since said numeral allowed equivalence to be made from a reference profile with incomplete data. Even worse would be to allow the update of a registration with referenced data that have no direct relationship with the product to be updated, which would be being permitted by this regulation." Finally, concerning the use of existing evaluations of the same active ingredient and/or product, note that the aforementioned code reduces the possibilities of such practice to specific cases:

"6.3 Use of existing evaluations of the same active ingredient and/or product If the applicant owns the data or can fully justify the right to use the data for their registration application, there are elements of existing registrations that can be used for new applications based on the same active ingredients. However, if the data were owned by another proprietor and the candidate applicant could not justify their right to use them, the responsible authority should not use the data and the evaluation of the first registrant to approve the second applicant's product." (Emphasis added).

In that regard, we consider that the challenged regulation undermines environmental and public health protection by enabling the use of referenced information, to the detriment of a full assessment of the pesticide or product.

2.- Regarding the reduction of requirements. Regarding this topic, the majority of the Chamber chose to consider that the action lacks adequate substantiation. In this respect, we indicated, on the one hand, that the lack of substantiation should be warned and prevented by the Chamber in a timely manner, under the terms of Article 80 of the Constitutional Jurisdiction Law (Ley de la Jurisdicción Constitucional). We recognize that the lack of substantiation can lead to the action being dismissed when it is heard on the merits. However, such a course of action should only occur when it is not clearly apparent from the record that the claim is admissible, as occurs in the sub lite case.

Thus, regarding this topic, the Attorney General's Office (Procuraduría General de la República) stated:

"...from reading Article 1 of the challenged Decree, it is possible to determine that for the revalidation process provided therein, fewer requirements are demanded than those provided in the revalidation process established by Decree 33495, since the latter required, in all cases, the confidential information file, the administrative file, as well as the acute toxicity studies defined in subsections d.1.1, d.1.2, d.1.3, d.1.4, d.1.5, d.1.6, and the ecotoxicity studies defined in subsections d.5.1.1, d.5.3.1, d.5.4.1, of section 7.2.

Note that for cases in which the product manufacturer has not changed, the challenged Decree only requires the application for the manufacturer update, the registration certificate issued by the authority of the country of origin, the qualitative-quantitative composition certificate, and proof of payment of the current fee.

For cases in which the product manufacturer has changed, although other requirements are demanded, these are still fewer than those provided by Decree 33495. Furthermore, the information for the technical file is allowed to be submitted via referenced information, and acute toxicity studies are only required when the technical grade active ingredient contains relevant impurities at levels above recognized international standards, or which are in Annex III of the Rotterdam Convention, or in the Stockholm Convention, or in the Montreal Protocol.

That is, in the revalidation process of Decree 33495, certain technical requirements were demanded that have not been contemplated by Decree 39995, despite the fact that in the latter's recitals it is acknowledged that this concerns the updating of products that have not complied with the toxicological, ecotoxicological, and environmental fate information requirements provided in international regulations and demanded since the entry into force of Decree 33495." For its part, the director of the Directorate of Environmental Quality Management of the Ministry of Environment and Energy pronounced as follows:

"DE N° 39995-MAG was issued arbitrarily and unilaterally by the MAG in order to complete the files of old products, including the registration of the technical grade active ingredients (IAGT) that support said formulated products (which, under previous regulations, did not have to be registered), as well as to define new validity periods for these old products. However, in evident breach of the CGR's provisions in report FOE-AM-19/2004, the participation of MINAE or the Ministry of Health was NOT contemplated, nor were the regulated parties requested to submit all the studies required to perform the environmental and health assessment, established in DE N° 33495-MAG-S-MINAE-MEIC and DE N° 40059-MAG-S-MINAE. Just as was established in DE N° 24997 and Law N° 8702, it was also not considered that the insufficient studies required in DE 39995 should be analyzed by the competent authority in environmental or health matters, which leads to these products continuing to be marketed without a ruling that guarantees the protection of the environment and human health." (Emphasis added. Official communication DIGECA-516-2018 of December 19, 2018).

3.- Concerning the precautionary principle and the reversal of the burden of proof. This topic was covered in our dissenting vote to judgment No. 2017-06668 of 10:50 hours on May 10, 2017, in the following terms:

"Dissenting vote of Judges Cruz Castro and Rueda Leal, drafted by the latter. With the customary respect, we depart from the majority opinion for the following reasons.

In their filing brief, the plaintiff explains that Article 7 of the challenged Regulation contravenes the precautionary principle and reverses the burden of proof in environmental matters. They reach this conclusion because the numeral in question obliges the competent ministries to '...demonstrate an unacceptable risk to human health, the environment, or agriculture...' in order for the Sanitary Service to restrict or prohibit the use of a registration.

In the judgment, the majority of this Tribunal considered that the claim was not admissible because the challenged norm rather protected the environment. In that sense, the resolution argues that the moment of application of the precautionary principle is during the processing of the registration inscription. Once the registration is inscribed, it will be necessary to demonstrate the unacceptable risk indicated by the norm.

As a starting point, it is necessary to recall what this Chamber has provided with respect to the precautionary principle in environmental matters:

'III.- The prevention of environmental risk. This obligation of the State being established at a constitutional level, it is important to appreciate how, at the level of international instruments for the protection of human rights, concrete obligations are also established that must be respected. In environmental matters, the duty of prevention that must exist in this area has been defined; the Rio Declaration, adopted at the United Nations Conference on Environment and Development, provides that:

"Principle 15.- In order to protect the environment, the precautionary approach shall be widely applied by States according to their capabilities. Where there are threats of serious or irreversible damage, lack of full scientific certainty shall not be used as a reason for postponing cost-effective measures to prevent environmental degradation." Prevention seeks to anticipate negative effects and ensure the protection, conservation, and adequate management of resources. Consequently, the guiding principle of prevention is based on the need to take and assume all precautionary measures to avoid or contain the possible affectation of the environment or people's health. Thus, should a risk of serious or irreversible damage exist—or a doubt regarding it—a precautionary measure must be adopted and even the activity in question postponed. The foregoing because in environmental matters, a posteriori coercion proves ineffective, since if the damage has occurred, the biological and socially harmful consequences may be irreparable; repression may have moral transcendence, but will hardly compensate for the damages caused to the environment.

As the cited international instrument points out, as does Article fifty of the Constitution itself, it is the State that is called upon to carry out this prevention work, and this Chamber has recognized this by affirming, through judgment number 2001-6503, of July 6, two thousand one, that:

"The third paragraph of Constitutional numeral 50 clearly indicates that the State must guarantee, defend, and preserve the right of every person to a healthy and ecologically balanced environment; which implies affirming that public entities are not only obliged to enforce—upon individuals and other public entities—environmental legislation, but also, above all, that they must adjust their actions to the dictates of those protective normative bodies. State institutions are the first called upon to comply with protective environmental legislation, with no justification existing to exempt them from complying with environmental requirements such as, by way of example, the environmental impact assessment required by the Organic Environmental Law for activities undertaken by public entities that, by their nature, may alter or destroy the environment." (Judgment 2010-11941 of 11:21 hours on July 9, 2010) As can be deduced from the transcription, the prevalence of the precautionary principle lies in the need to avoid serious and irreparable damage to the environment, obliging the adoption of measures that anticipate said damage. That is, given the possibility of an irreversible or serious danger materializing, the duty of the State to act arises, requiring for this only the existence of a reasonable doubt of risk to the environment.

Now, contrary to what the majority defends, the precautionary principle is not limited to a stage of the administrative procedure, but rather constitutes one of the principles that must guide administrative action at all times.

We consider that the interpretation made by the Chamber could mean the creation of a presumption in favor of the registration and against the environment and human health. In this way, the burden would be imposed on the State to prove the existence of the aforementioned risk, in order to overturn such presumption. But furthermore, merely demonstrating the risk is not enough; the State must also prove, according to the majority, that said risk is unacceptable, which makes the possibility of acting in favor of the environment and human health even more difficult.

These requirements could be unreasonable and disproportionate, since months or years may elapse between the moment the reasonable doubt arises and the moment the existence of a risk of an unacceptable degree can be demonstrated. This time lapse would enable the risk to materialize and cause irreversible or serious harm to the environment and human health. Thus, there could be a contradiction between the de lege lata situation and the purposes of the precautionary principle, which clearly justifies the action being processed.

The plaintiff may also be correct in criticizing the reversal of the burden of proof. In this case, the registration holder has all the technical information related to the product and, furthermore, is the subject interested in maintaining its legal use in the country, which makes it reasonable to impose upon them the burden of proving its harmlessness to the environment and human health.

We consider that all these topics must be analyzed more thoroughly by the full Chamber, granting a hearing to the Attorney General's Office and the competent bodies.

Furthermore, given the current environmental problems and the international consensus regarding the imminence of environmental problems that threaten the entire human race (such as climate change, recognized in the Paris Agreement by 193 States), it surprises the undersigned that the majority of this Chamber advocates the non-application of the precautionary principle and, rather, defends the imposition of qualified requirements on the Administration when it seeks to ensure the environment and human health.

By virtue of the arguments presented, we dissent and order the action to proceed." 4.- Regarding citizen participation.

In judgment No. 2021-25386 of 13:10 hours on November 10, 2021, we referred to citizen participation in the following terms:

"As was recorded in the dissenting vote to judgment No. 2017-1163 of 9:40 hours on January 27, 2017, we consider that from Article 9 of the Political Constitution it is extracted that citizen participation, beyond a general principle, has been instituted as a true fundamental right in light of the conventional framework that accompanies and integrates our system of fundamental rights.

Precisely, in judgment No. 2013-017305 of 11:32 hours on December 20, 2013, the Constitutional Chamber considers that the right to citizen participation in decision-making has become one of the fundamental pillars on which the democratic system rests. In our country, the constitutional legislator enshrined this right in Article 9 of the Political Constitution by providing that the Government of the Republic is popular, representative, participatory, alternating, and responsible (emphasis not in the original), according to the reform brought about by Law No. 8364 of July 1, 2003, published in La Gaceta No. 146 of July 31, 2003. This mandate of the Fundamental Law, particularly the quality of "participatory", has guided subsequent constitutional and infra-constitutional normative development. Thus, a series of mechanisms have been established that seek to ensure that the right to participatory government can be applied efficiently and effectively, so that it does not remain merely a paper right; examples of this are the referendum for the approval or repeal of laws and partial reforms to the Constitution, or the popular initiative in the formation of laws (see, among others, judgment number 2005-05649 of 14:39 hours on May 11, 2005).

The right to participatory government not only embodies a recognition of the highest legal-positive rank to the function of political control by the inhabitants of the Republic, but also signifies a revaluation of their role in the processes of formulation, application, and control of public policy. By the will of the constituent legislator, which this Chamber should not and cannot ignore, the right to participatory government stands as a fundamental pillar of our democratic system (a matter erroneously ignored by the minority vote, which lowers citizen participation from the category of a right to a general principle, in clear opposition to the jurisprudential line of this Chamber, as demonstrated below), which is consistent with a political system based on tolerance, pluralism, and respect for freedom.

As we indicated supra, this categorization of participatory government or citizen participation as a right is explained through the conventional support contained in various international human rights instruments.

For example, Article 21 of the 1948 Universal Declaration of Human Rights provides that 'everyone has the right to take part in the government of his country, directly or through freely chosen representatives' (emphasis not in the original).

Consistent with the foregoing, Article 25 of the International Covenant on Civil and Political Rights expressly recognizes the right of citizens: '(...) to take part in the conduct of public affairs, directly or through freely chosen representatives'.

In the same sense, the Inter-American Democratic Charter states in Article 5 that: 'Representative democracy is strengthened and deepened by permanent, ethical, and responsible participation of the citizenry within a framework of legality conforming to the respective constitutional order.' More vehemently, Article 6 of this Charter establishes that: 'The participation of the citizenry in decisions relating to their own development is a right and a responsibility. It is also a necessary condition for the full and effective exercise of democracy. Promoting and fostering diverse forms of participation strengthens democracy.' (Emphasis not in the original).

The United Nations Human Rights Council also recognized citizen participation as fundamental for the protection of the environment:

'Recognizing also that the exercise of human rights, including the freedom to seek, receive and impart information and to participate effectively in the conduct of government and public affairs and the right to an effective remedy, is fundamental for the protection of a clean, healthy, safe and sustainable environment,' (Human Rights Council, 46th session, A/HRC/RES/46/7 of March 23, 2021).

It is also important to highlight that, recently, the United Nations Human Rights Council, in resolution A/HRC/RES/48/13 of October 8, 2021, has come to grant the status of a human right to effective participation in environmental matters. In this regard, it stated:

'Recognizing that the exercise of human rights, including the rights to seek, receive and impart information and to participate effectively in the conduct of government and public affairs and in decision-making relating to the environment, as well as the right to an effective remedy, is fundamental for the protection of a clean, healthy and sustainable environment.'" (The highlighting does not correspond to the original).</span></p><p style="margin-top:12pt; margin-bottom:12pt; text-align:justify"><span style="font-family:Arial">&#xa0;</span></p><p style="margin-top:12pt; margin-bottom:12pt; text-align:justify"><span style="font-family:Arial">For its part, in Advisory Opinion OC-23/17 of November 15, 2017, the Inter-American Court of Human Rights emphasized that:</span></p><p style="margin-top:12pt; margin-bottom:12pt; text-align:justify"><span style="font-family:Arial">&#xa0;</span></p><p style="margin-top:12pt; margin-bottom:12pt; text-align:justify"><span style="font-family:Arial">“226. Public participation represents one of the fundamental pillars of instrumental or procedural rights, given that it is through participation that persons exercise democratic control over State management and can thus question, inquire into, and consider the fulfillment of public functions. In that sense, participation allows persons to be part of the decision-making process and for their opinions to be heard. In particular, public participation facilitates communities demanding accountability from public authorities for decision-making and, at the same time, improves the efficiency and credibility of governmental processes. As has been mentioned on previous occasions, public participation requires the application of the principles of publicity and transparency and, above all, must be supported by access to information that enables social control through effective and responsible participation” (emphasis added).</span></p><p style="margin-top:12pt; margin-bottom:12pt; text-align:justify"><span style="font-family:Arial">&#xa0;</span></p><p style="margin-top:12pt; margin-bottom:12pt; text-align:justify"><span style="font-family:Arial">A position that had also been adopted in the judgment of September 19, 2006, concerning the case “Claude Reyes et al. vs. Nombre78715”, in which it was ordered:</span></p><p style="margin-top:12pt; margin-bottom:12pt; text-align:justify"><span style="font-family:Arial">&#xa0;</span></p><p style="margin-top:12pt; margin-bottom:12pt; text-align:justify"><span style="font-family:Arial">“86. In this regard, the State’s conduct must be governed by the principles of publicity and transparency in public management, which makes it possible for persons under its jurisdiction to exercise democratic control over State management, in such a way that they can question, inquire into, and consider whether public functions are being adequately fulfilled. Access to information under the State’s control that is of public interest can enable participation in public management, through the social control that can be exercised with such access. 87. Democratic control by society through public opinion fosters transparency in State activities and promotes the accountability of officials for their public management. Therefore, for persons to be able to exercise democratic control, it is essential that the State guarantee access to information of public interest under its control. By allowing the exercise of that democratic control, greater participation by persons in the interests of society is fostered.” (Emphasis added).</span></p><p style="margin-top:12pt; margin-bottom:12pt; text-align:justify"><span style="font-family:Arial">&#xa0;</span></p><p style="margin-top:12pt; margin-bottom:12pt; text-align:justify"><span style="font-family:Arial">Thus, this conventional recognition of citizen participation hermeneutically affects its legal nature, since it transforms it from a constitutional principle into a true collective fundamental right.</span></p><p style="margin-top:12pt; margin-bottom:12pt; text-align:justify"><span style="font-family:Arial">&#xa0;</span></p><p style="margin-top:12pt; margin-bottom:12pt; text-align:justify"><span style="font-family:Arial">In this way, citizen participation represents an essential aspect of the democratic and republican model of this century, in which citizen oversight (control ciudadano), transparency, and accountability (rendición de cuentas) stand out as expressive elements of this type of political regime, which in turn confers much greater legitimacy on political decision-making, a key issue when it comes to governance (gobernabilidad). Thus, within the framework of this type of regime—that is, with active and full citizen participation—participatory government has a greater impact, favoring decision-making through more open and transparent means.</span></p><p style="margin-top:12pt; margin-bottom:12pt; text-align:justify"><span style="font-family:Arial">&#xa0;</span></p><p style="margin-top:12pt; margin-bottom:12pt; text-align:justify"><span style="font-family:Arial">Precisely, one of the mechanisms devised to comply with the provisions of constitutional numeral 9 is the public hearing (audiencia pública), through which interested persons can assert their rights or express their views, actively participating in matters of national or local relevance, and bringing to the Administration’s attention all anomalies or disagreements regarding a project to be developed.</span></p><p style="margin-top:12pt; margin-bottom:12pt; text-align:justify"><span style="font-family:Arial">&#xa0;</span></p><p style="margin-top:12pt; margin-bottom:12pt; text-align:justify"><span style="font-family:Arial">Thus, the public hearing is a typical instrument of a republican democracy, through which citizen participation in the public decision-making process is fostered. Due to its significance, the hearing must be conducted in such a way as to guarantee the greatest possible participation of persons who may be affected; hence, any action or omission that hinders the foregoing constitutes an open violation of the constitutional right to citizen participation (see, among others, judgment number 2009-018223, 12:34 hours, November 27, 2009).</span></p><p style="margin-top:12pt; margin-bottom:12pt; text-align:justify"><span style="font-family:Arial">&#xa0;</span></p><p style="margin-top:12pt; margin-bottom:12pt; text-align:justify"><span style="font-family:Arial">Regarding the participatory nature of the public hearing, as indicated, article 9 of the Political Constitution itself compels it, since the description “participatory” provided therein implies, among other aspects, that the Government must be an articulator of what is defined by popular deliberation when this is mandatory, while in the formulation of public policy, within the possibilities posed by the current positive legal framework, it is obligated to listen to the views of affected individuals or groups, whether or not such views are binding.</span></p><p style="margin-top:12pt; margin-bottom:12pt; text-align:justify"><span style="font-family:Arial">&#xa0;</span></p><p style="margin-top:12pt; margin-bottom:12pt; text-align:justify"><span style="font-family:Arial">In other words, in the current republican democracy, citizens enjoy, by constitutional mandate, not only the right to vote to exercise their right to participatory government, but also a host of instruments of diverse nature to contribute to governmental decision-making and political oversight (control político), which allows them to exert direct influence on major public decisions.</span></p><p style="margin-top:12pt; margin-bottom:12pt; text-align:justify"><span style="font-family:Arial">&#xa0;</span></p><p style="margin-top:12pt; margin-bottom:12pt; text-align:justify"><span style="font-family:Arial">Within this context, it is worth highlighting that this Court, in judgment No. 2018004117, 9:15 hours, March 13, 2018, elaborated on public consultation in environmental matters, emphasizing that this mechanism is a pillar in decision-making related to the environment. Likewise, by way of soft law, it resorted to a particularly relevant instrument regarding access to environmental information and citizen participation: the “Convention on Access to Information, Public Participation in Decision-Making and Access to Justice in Environmental Matters”, better known as the “Aarhus Convention”. In this regard, the aforementioned ruling stated:</span></p><p style="margin-top:12pt; margin-bottom:12pt; text-align:justify"><span style="font-family:Arial">&#xa0;</span></p><p style="margin-top:12pt; margin-bottom:12pt; text-align:justify"><span style="font-family:Arial">“The Aarhus Convention, for its part, in article 6.2.3.4 provides:</span></p><p style="margin-top:12pt; margin-bottom:12pt; text-align:justify"><span style="font-family:Arial">&#xa0;</span></p><p style="margin-top:12pt; margin-bottom:12pt; text-align:justify"><span style="font-family:Arial">“2. When a decision-making process regarding the environment is initiated, the public concerned shall be informed, as appropriate, effectively and in a timely manner, by means of public notice or individually, as the case may be, at the beginning of the process. The information shall refer in particular to:</span></p><p style="margin-top:12pt; margin-bottom:12pt; text-align:justify"><span style="font-family:Arial">&#xa0;</span></p><p style="margin-top:12pt; margin-bottom:12pt; text-align:justify"><span style="font-family:Arial">a) The proposed activity, including the corresponding application on which a decision will be taken;</span></p><p style="margin-top:12pt; margin-bottom:12pt; text-align:justify"><span style="font-family:Arial">&#xa0;</span></p><p style="margin-top:12pt; margin-bottom:12pt; text-align:justify"><span style="font-family:Arial">b) The nature of the possible decisions or the draft decision;</span></p><p style="margin-top:12pt; margin-bottom:12pt; text-align:justify"><span style="font-family:Arial">&#xa0;</span></p><p style="margin-top:12pt; margin-bottom:12pt; text-align:justify"><span style="font-family:Arial">c) The public authority responsible for making the decision;</span></p><p style="margin-top:12pt; margin-bottom:12pt; text-align:justify"><span style="font-family:Arial">&#xa0;</span></p><p style="margin-top:12pt; margin-bottom:12pt; text-align:justify"><span style="font-family:Arial">d) The envisaged procedure, in particular, the cases in which this information may be provided:</span></p><p style="margin-top:12pt; margin-bottom:12pt; text-align:justify"><span style="font-family:Arial">&#xa0;</span></p><p style="margin-top:12pt; margin-bottom:12pt; text-align:justify"><span style="font-family:Arial">i) The date on which the procedure will begin;</span></p><p style="margin-top:12pt; margin-bottom:12pt; text-align:justify"><span style="font-family:Arial">&#xa0;</span></p><p style="margin-top:12pt; margin-bottom:12pt; text-align:justify"><span style="font-family:Arial">ii) The possibilities offered to the public to participate in it;</span></p><p style="margin-top:12pt; margin-bottom:12pt; text-align:justify"><span style="font-family:Arial">&#xa0;</span></p><p style="margin-top:12pt; margin-bottom:12pt; text-align:justify"><span style="font-family:Arial">iii) The date and place of any envisaged public hearing;</span></p><p style="margin-top:12pt; margin-bottom:12pt; text-align:justify"><span style="font-family:Arial">&#xa0;</span></p><p style="margin-top:12pt; margin-bottom:12pt; text-align:justify"><span style="font-family:Arial">iv) The public authority from which relevant information can be obtained and where the relevant information has been deposited for the public to examine it;</span></p><p style="margin-top:12pt; margin-bottom:12pt; text-align:justify"><span style="font-family:Arial">&#xa0;</span></p><p style="margin-top:12pt; margin-bottom:12pt; text-align:justify"><span style="font-family:Arial">v) The public authority or any other public body or competent body to which comments or questions may be submitted and the time frame foreseen for the communication of comments or questions;</span></p><p style="margin-top:12pt; margin-bottom:12pt; text-align:justify"><span style="font-family:Arial">&#xa0;</span></p><p style="margin-top:12pt; margin-bottom:12pt; text-align:justify"><span style="font-family:Arial">vi) An indication of the environmental information relating to the proposed activity that is available; and</span></p><p style="margin-top:12pt; margin-bottom:12pt; text-align:justify"><span style="font-family:Arial">&#xa0;</span></p><p style="margin-top:12pt; margin-bottom:12pt; text-align:justify"><span style="font-family:Arial">e) The fact that the activity is subject to a national or transboundary environmental impact assessment procedure.</span></p><p style="margin-top:12pt; margin-bottom:12pt; text-align:justify"><span style="font-family:Arial">&#xa0;</span></p><p style="margin-top:12pt; margin-bottom:12pt; text-align:justify"><span style="font-family:Arial">3. For the different phases of the public participation procedure, reasonable time frames shall be provided allowing sufficient time to inform the public in accordance with paragraph 2 above and for the public to prepare and participate effectively during the entire environmental decision-making process.</span></p><p style="margin-top:12pt; margin-bottom:12pt; text-align:justify"><span style="font-family:Arial">&#xa0;</span></p><p style="margin-top:12pt; margin-bottom:12pt; text-align:justify"><span style="font-family:Arial">4. Each Party shall adopt measures so that public participation begins at the start of the procedure, that is, when all options and solutions are still possible and when the public can exert real influence.”</span></p><p style="margin-top:12pt; margin-bottom:12pt; text-align:justify"><span style="font-family:Arial">&#xa0;</span></p><p style="margin-top:12pt; margin-bottom:12pt; text-align:justify"><span style="font-family:Arial">In accordance with the foregoing, consultation must be fostered transparently and with the greatest possible information. This generates better management of natural resources, contributes to transparency, and to the adequate handling of public funds. Let us remember that the environmental issue is a matter for all members of society, not just the government, and therefore it is also the responsibility of each citizen to ensure the conservation of the environment and to seek sustainable development. That is why it must integrally encompass the different sectors of the population (…)”. (Emphasis added).</span></p><p style="margin-top:12pt; margin-bottom:12pt; text-align:justify"><span style="font-family:Arial">&#xa0;</span></p><p style="margin-top:12pt; margin-bottom:12pt; text-align:justify"><span style="font-family:Arial">Additionally, in the aforementioned pronouncement, this Chamber underscored that the citizen hearing, as a manifestation of the democratic principle, must not become a simple formality that merely needs to be scheduled, although it must also not be instrumentalized as a mere obstacle to the issuance of an administrative decision.</span></p><p style="margin-top:12pt; margin-bottom:12pt; text-align:justify"><span style="font-family:Arial">&#xa0;</span></p><p style="margin-top:12pt; margin-bottom:12pt; text-align:justify"><span style="font-family:Arial">Related to the above, this Chamber has repeatedly indicated that the Constitution is characterized by its supremacy and its direct and immediate efficacy (eficacia directa e inmediata), by virtue of which the rights and guarantees it confers are directly enforceable and binding upon all Public Powers. Thus, in judgment No. 1992-3194, 16:00 hours, October 27, 1992, it specified:</span></p><p style="margin-top:12pt; margin-bottom:12pt; text-align:justify"><span style="font-family:Arial">&#xa0;</span></p><p style="margin-top:12pt; margin-bottom:12pt; text-align:justify"><span style="font-family:Arial">“(…) The Political Constitution, in its unanimous contemporary conception, is not only ‘supreme’ as a criterion of validity for itself and for the rest of the legal system, but also a set of legally binding fundamental norms and principles, therefore, enforceable by themselves, against all public authorities, and even private parties, without the need for other norms or acts to develop them or make them applicable—except in qualified cases of exception, in which without them its application is impossible—; with the consequence that both administrative and jurisdictional authorities have the power-duty to directly apply the Law of the Constitution in its full sense, even in the absence of a lower-ranking norm or disapplying those that oppose it.”</span></p><p style="margin-top:12pt; margin-bottom:12pt; text-align:justify"><span style="font-family:Arial">&#xa0;</span></p><p style="margin-top:12pt; margin-bottom:12pt; text-align:justify"><span style="font-family:Arial">For its part, in judgment No. 1995-1185, 14:33 hours, March 2, 1995, this Court confirmed:</span></p><p style="margin-top:12pt; margin-bottom:12pt; text-align:justify"><span style="font-family:Arial">&#xa0;</span></p><p style="margin-top:12pt; margin-bottom:12pt; text-align:justify"><span style="font-family:Arial">“If the Political Constitution has a supreme normative character, it must effectively shape and condition the validity and effectiveness of all inferior or subordinate norms, and serves as a parameter to legitimize or not the actions of any public authority and even of private subjects.... The principle of supremacy of the Constitution, in the Costa Rican case, is not only expressly enshrined in article 10, but is very clearly complemented with respect to the body responsible for maintaining or preserving it, as we will analyze below. What we have expressed so far revolves around the fact that the Constitution has direct efficacy and binds without the need for intermediation by any other norm. And, for this reason, all authorities, in general, have the capacity and power to apply, develop, and expand the fundamental rights contained in the Political Constitution. If this were not so, the entire argument about the hierarchy of constitutional norms, principles, and values would be reduced to an unsustainable fantasy. It would be mere science fiction, an entelechy, in which two legal worlds simultaneously exist located on different planes and without communication between them.”</span></p><p style="margin-top:12pt; margin-bottom:12pt; text-align:justify"><span style="font-family:Arial">&#xa0;</span></p><p style="margin-top:12pt; margin-bottom:12pt; text-align:justify"><span style="font-family:Arial">In conclusion, citizen participation constitutes a constitutional and conventional right that stands as a quality of the republican democratic system. In this regard, the rights enshrined in the Fundamental Law, to varying degrees depending on whether their content is more or less programmatic, have direct efficacy and bind without the need for any norm. Even their effectiveness through infra-constitutional normative development and its application is not exempt from jurisdictional constitutional control, when regulations, actions, or omissions are noticed that represent an injury to the hard core (Kernbereich) of that constitutional good.”</span></p><p style="margin-top:12pt; margin-bottom:12pt; text-align:justify"><span style="font-family:Arial">&#xa0;</span></p><p style="margin-top:12pt; margin-bottom:12pt; text-align:justify"><span style="font-family:Arial">In the case at bar (sub lite), we consider that the challenged decree violates the right to citizen participation in matters of utmost importance for the population, such as the environment and public health. The relevance of citizen participation in this matter is recognized in the aforementioned “International Code of Conduct on the Distribution and Use of Pesticides. Guidelines for the Registration of Pesticides”, whose point 3 (The principles of pesticide registration) states:</span></p><p style="margin-top:12pt; margin-bottom:12pt; text-align:justify"><span style="font-family:Arial">&#xa0;</span></p><p style="margin-top:12pt; margin-bottom:12pt; text-align:justify"><span style="font-family:Arial">“Governments should facilitate the exchange of information among responsible authorities through national institutions, international, regional, and sub-regional organizations, as well as public sector groups. They should develop legislation and regulations to allow the exchange of information with the public on the risks and benefits of pesticides and also to facilitate public participation in the management of the country’s pesticides.” (Underlining added).</span></p><p style="margin-top:12pt; margin-bottom:12pt; text-align:justify"><span style="font-family:Arial">Citizen participation is also included in its point 10 (Coordination and collaboration):</span></p><p style="margin-top:12pt; margin-bottom:12pt; text-align:justify"><span style="font-family:Arial">&#xa0;</span></p><p style="margin-top:12pt; margin-bottom:12pt; text-align:justify"><span style="font-family:Arial">“10.1.3 Regulated community</span></p><p style="margin-top:12pt; margin-bottom:12pt; text-align:justify"><span style="font-family:Arial">&#xa0;</span></p><p style="margin-top:12pt; margin-bottom:12pt; text-align:justify"><span style="font-family:Arial">There should be periodic dialogues between the responsible authority and the regulated community, including the pesticide industry, pesticide sellers, professional pest control operators, pesticide advertising agencies, and the general public, so that they receive feedback and suggestions on the implementation and application of pesticide registration in the country. The responsible authority should encourage the pesticide industry to develop low-risk pesticide products as well as product stewardship activities.</span></p><p style="margin-top:12pt; margin-bottom:12pt; text-align:justify"><span style="font-family:Arial">&#xa0;</span></p><p style="margin-top:12pt; margin-bottom:12pt; text-align:justify"><span style="font-family:Arial">10.1.4 Civil society</span></p><p style="margin-top:12pt; margin-bottom:12pt; text-align:justify"><span style="font-family:Arial">&#xa0;</span></p><p style="margin-top:12pt; margin-bottom:12pt; text-align:justify"><span style="font-family:Arial">The responsible authority may have frequent dialogue with civil society representatives to address issues related to pesticide registration in the country. Civil society groups can in particular be important for providing feedback on the use of pesticides, and on the real and potential problems that may arise.” (Underlining added).”</span></p><p style="margin-top:12pt; margin-bottom:12pt; text-align:justify"><span style="font-family:Arial">&#xa0;</span></p><p style="margin-top:12pt; margin-bottom:12pt; text-align:justify"><span style="font-family:Arial">&#xa0;</span><span style="font-family:Arial">Additionally, with respect to the specific case, we establish the following defects that warrant declaring the decree unconstitutional.</span></p><p style="margin-top:12pt; margin-bottom:12pt; text-align:justify"><span style="font-family:Arial">&#xa0;</span></p><p style="margin-top:12pt; margin-bottom:12pt; text-align:justify"><span style="font-family:Arial">&#xa0;</span><span style="font-family:Arial">Regarding the reduction of requirements for the approval of registration (valida), we determine that article 1 does not require acute toxicity and ecotoxicity studies, as Decree 33495 did. Furthermore, article 1.1 eliminated the requirement for the manufacturer’s update authorization, the certificate of registration issued by the authority of the country of origin, and the endorsement of a chemist for the qualitative-quantitative composition certificate. Article 1.2 eliminated the certificate of registration issued by the authority of the country of origin.</span></p><p style="margin-top:12pt; margin-bottom:12pt; text-align:justify"><span style="font-family:Arial">&#xa0;</span></p><p style="margin-top:12pt; margin-bottom:12pt; text-align:justify"><span style="font-family:Arial">&#xa0;</span><span style="font-family:Arial">Likewise, regarding the use of referenced information, we adopt the observations of the Office of the Attorney General (Procuraduría General de la República):</span></p><p style="margin-top:12pt; margin-bottom:12pt; text-align:justify"><span style="font-family:Arial">&#xa0;</span></p><p style="margin-top:12pt; margin-bottom:12pt; text-align:justify"><span style="font-family:Arial">“… although the Attorney General’s Office is not a technical body in the matter, it can be pointed out that even though the challenged Decree amends articles 1.2.b and 6 of Decree 39995 that allowed the registration of products through referenced information, it maintains that possibility, as article 1.2.c allows the use of international specifications to prove that the technical material to be updated does not have relevant impurities, indicating in the fifth recital (considerando) that international specifications and standards are a technical and scientific reference to determine that active ingredient grade technical grade materials do not contain relevant impurities at levels above the international standards or specifications, and that only those relevant impurities are the ones that have toxicological or ecotoxicological relevance that could cause harm to health or the environment.</span></p><p style="margin-top:12pt; margin-bottom:12pt; text-align:justify"><span style="font-family:Arial">&#xa0;</span></p><p style="margin-top:12pt; margin-bottom:12pt; text-align:justify"><span style="font-family:Arial">In the same vein, article 3 provides that formulated pesticides that do not have an associated technical grade active ingredient registration will be granted that registration directly when the manufacturer of that active ingredient has been updated; article 6 provides that, once the requirements are met, registration will be granted for ten years and that, during that period, the SFE will verify that already-approved registrations of technical grade active ingredient have chemical equivalence with the reference profile of that active ingredient and that, in the absence of such a profile, it must verify that they do not contain relevant impurities; and article 11 endorses the homologation of labels and leaflets with those of other already-registered products that have the same active ingredient and equal concentration, without considering the effects that the other product components or the method or form of manufacture could have.</span></p><p style="margin-top:12pt; margin-bottom:12pt; text-align:justify"><span style="font-family:Arial">&#xa0;</span></p><p style="margin-top:12pt; margin-bottom:12pt; text-align:justify"><span style="font-family:Arial">The challenged norm does not establish in what way the information will be verifiable, how to determine which international specification may be used, the way to determine the equivalence of products, or whether the reference profile to be used must be a registration that has complete information, and therefore, that covers acute toxicity, ecotoxicity, chronic toxicology, ecotoxicological studies, and other studies on the abiotic environment as required by article 5 of the Law for the Import and Quality Control of Agrochemicals (Ley para la Importación y Control de la Calidad de Agroquímicos) and the Manual on Development and Use of FAO and WHO Specifications for Pesticides.</span></p><p style="margin-top:12pt; margin-bottom:12pt; text-align:justify"><span style="font-family:Arial">&#xa0;</span></p><p style="margin-top:12pt; margin-bottom:12pt; text-align:justify"><span style="font-family:Arial">Hence, as indicated in the previous report, by not precisely establishing the rules to which the competent authority must adjust to verify the information, it is possible that the updating of registrations is allowed with referenced information that does not meet the indicated requirements, and, therefore, this would imply the updating of product registrations without a prior evaluation of the environmental and health risks of their application.”</span></p><p style="margin-top:12pt; margin-bottom:12pt; text-align:justify"><span style="font-family:Arial">By virtue of the foregoing, we determine that the challenged decree contravenes the constitutional block (bloque de constitucionalidad) and violates the right to a healthy and ecologically balanced environment.</span></p> For that reason, we dissent and declare the action admissible.

Fernando Cruz C. Paul Rueda L.

VCG12/2023 Res. no. Telf5455 Note by Magistrate Rueda Leal. As I have expressed in other cases, I believe that a quality of a diffuse interest (interés difuso) lies precisely in the fact that its impact is general—that is, it affects an entire population or broad sectors of it—within a context where it is not required that the affected parties know each other (they might even lack any legal nexus or relationship among them), but it does require the presence of a shared situation of harm or danger to a constitutional right that, equally and without any need for individualization, encompasses and aggregates an entire society in the abstract. Its defense has the purpose of satisfying a need of society as such; therefore, it transcends that of a human being considered individually or collectively. In ruling no. 2019-17397 of 12:54 p.m. on September 11, 2019, this Court reiterated the following:

"(...) Second, the possibility of appearing in defense of 'diffuse interests' is provided for; this concept, whose content has been gradually outlined by this Chamber, could be summarized in the terms used in the ruling of this court number 3750-93, of three o'clock in the afternoon on July 30, 1993) '... Diffuse interests, although difficult to define and even more difficult to identify, cannot be in our law—as this Chamber has already stated—merely collective interests; nor so diffuse that their ownership is confused with that of the national community as a whole, nor so concrete that determined or easily identifiable persons, or personalized groups, are identified or easily identifiable against them, whose standing would derive not from diffuse interests, but from corporate ones that concern a community as a whole. It involves, then, individual interests, but at the same time, diluted in more or less extensive and amorphous groups of people who share an interest and, therefore, suffer a harm, actual or potential, more or less equal for all, which is why it is rightly said that these are equal interests of the groups that find themselves in certain circumstances and, at the same time, of each one of them. That is, diffuse interests partake of a dual nature, since they are at once collective—for being common to a generality—and individual, for which reason they can be claimed in such character'."

In summary, diffuse interests are those whose ownership belongs to groups of people not formally organized, but united around a particular social need, a physical characteristic, their ethnic origin, a particular personal or ideological orientation, the consumption of a certain product, etc. The interest, in these cases, is blurred, diluted (diffuse) among an unidentified plurality of subjects. In these cases, of course, the challenge that a member of one of these sectors could bring, relying on paragraph 2 of Article 75, must necessarily refer to provisions that affect them as such. This Chamber has enumerated various rights to which it has given the qualification of "diffuse," such as the environment, cultural heritage, the defense of the country's territorial integrity, and the proper management of public spending, among others. In this regard, two clarifications must be made: on the one hand, the aforementioned assets transcend the sphere traditionally recognized for diffuse interests, since they refer in principle to aspects that affect the national community and not particular groups thereof; an environmental harm does not barely affect the residents of a region or the consumers of a product, but rather harms or seriously endangers the natural heritage of the entire country and even of Humanity; likewise, the defense of the proper management of public funds authorized in the Budget of the Republic is an interest of all inhabitants of Costa Rica, not just of any one group of them. On the other hand, the enumeration made by the Constitutional Chamber is no more than a simple description inherent to its obligation—as a jurisdictional body—to limit itself to hearing the cases submitted to it, without it being possible in any way to understand that only those rights expressly recognized as such by the Chamber can be considered diffuse rights; the foregoing would imply an undesirable reversal of the scope of the Rule of Law, and its correlative "State of rights," which—as in the case of the Costa Rican model—starts from the premise that what must be express are the limits on freedoms, since these underlie the human condition itself and therefore do not require official recognition. Finally, when paragraph 2 of Article 75 of the Ley de la Jurisdicción Constitucional speaks of interests "that concern the community as a whole," it refers to the legal rights explained in the preceding lines, that is, those whose ownership rests in the very holders of sovereignty, in each one of the inhabitants of the Republic.

It is not, therefore, a matter of any person being able to come to the Constitutional Chamber in protection of any interests (popular action), but rather that every individual can act in defense of those rights that affect the entire national community, without any attempt at an exhaustive enumeration being valid in this field either" (see ruling No. 2007-01145)." In accordance with what has been set forth and upheld by this Court in its jurisprudence, it involves, then, individual interests, but at the same time, diluted in more or less extensive and amorphous groups of people who share an interest and, therefore, suffer a harm, actual or potential, more or less equal for all, which is why it is rightly said that these are equal interests of the groups that find themselves in certain circumstances and, at the same time, of each one of them. It is for this reason, precisely, that, as of ruling no. 2021-2185 of 12:51 p.m. on February 3, 2021, I consider, unlike the Majority of this Court, that some of these interests can be embodied in a specific, concrete case, without thereby losing their condition as diffuse interests, as occurs with environmental protection, whose impact affects one person and everyone in general; and such impact can be individualized in a particular situation, such as, for example, the construction of a factory in a specific neighboring sector, without the respective environmental studies, whose negative effects affect the planet's ozone layer. Undoubtedly, the result of a claim or proceeding that a neighbor might bring against that factory will not only affect their own interests but also those of the rest of the community. Therefore, it constitutes a diffuse interest; and yet, it is also the object of a particular individualized situation. That being said, this does not mean, in any way, that in every situation invoked one can allege the existence of a diffuse interest, even if it can be the object of a particular situation. Let us remember that for an interest to be considered "diffuse," it must not only affect a community, but must also be blurred, diffused within that community. If it does not produce such an effect, it cannot be considered a diffuse interest. In this case, the diffuse interest alleged by the plaintiffs is environmental protection. For this reason and based on the clarifications just made, I consider the merits of the case.

Paul Rueda L.

VCG12/2023 Res. No. 2023-002389 NOTE BY MAGISTRATE CRUZ CASTRO.- The importance of protecting the right to the environment, to health, and to food security, and in application of the constitutional environmental principles of progressivity and non-regression, the precautionary principle (principio precautorio), the preventive principle (principio preventivo), the principle in dubio pro natura, and the principle of objectivization (principio de objetivación) regarding pesticide regulation.

As I have considered in other cases where the issue of pesticides has come for discussion before this Chamber, it is relevant to start from the jurisprudential precedent of ruling no. 2011-016937 of 2:36 p.m. on December 07, 2011: (https://nexuspj.poder-judicial.go.cr/document/sen-1-0007-532977). Here the Chamber outlined the constitutional framework under which a regulation for the registration, use, and control of pesticides must be analyzed, when in the unconstitutionality action filed against Decreto Ejecutivo number 33495-MAG-S-MINAE-MEIC of October 31, 2006, the following was stated:

VI.- FOOD SECURITY, TRACEABILITY (TRAZABILIDAD OR RASTREABILIDAD), AND THE APPLICATION OF THE PRECAUTIONARY PRINCIPLE. This Chamber, in resolution 13924-2011 of 5:59 p.m. on May 10, referred to the issue of agri-food security: "The right to food has been incorporated into most legal systems as a human right, today recognized in International Treaties and even elevated in many countries to constitutional rank. Agri-food law must be understood as the set of special, systematically ordered norms that regulate the agri-food product and its production chain in all its phases, from production to consumption, controlling the stages of the agri-food enterprise and its productive activity for the purpose of guaranteeing the consumption of healthy and safe food, in order to protect the health of people, animals, and plants, or to ensure the food supply of the population. From the above definition derives the need for the interpreter to contribute to the formulation and systematization of these special norms, in order to establish, within the framework of a general theory of agri-food law, what the object, subjects, possible normative sources, activities, and general principles that should guide the discipline are. Quality and health requirements in turn impose traceability requirements for the product throughout the entire agri-food chain. In the different areas of activity, the global approach 'from farm to fork' is adopted, which characterizes this policy and consolidates the indivisible character of the food chain, and focuses on the decisive role played by the National Animal Health Service. The conditions of any traceability system are: 1. At all stages of the chain, food health must be ensured; 2. Agri-food companies must be able to identify any subject in the chain; 3. Companies must establish the procedures and methods necessary for this; 4. Systems and procedures must be put into practice to be able to identify the delivered products; 5. Marketed foods must be identified for purposes of determining their origin. The need to find a balance between mechanisms for protecting food security for preventive purposes—the precautionary principle—and the guarantee of free movement of agri-food products that meet international scientific standards is evident. The foregoing produces as a requirement the 'monitoring' of agricultural and food products, that is, traceability throughout the chain, in order to determine the eventual liability that may correspond to the agricultural producer or the company that transforms the products into food, even at each phase of the chain." Furthermore, the Ley de Protección Fitosanitaria, No. 7664 of April 8, 1997, also incorporates rules to avoid and prevent the introduction and spread of pests that threaten food security and the economic activity based on agricultural production, preventing such measures from unnecessarily constituting an obstacle to free trade (Article 2). For this reason, control mechanisms are established for the establishment, registration, and listing of inputs for agricultural use, even establishing rules of agri-environmental liability when damage and harm are caused to agriculture, the environment, and human and animal health (Chapter IV). Within this context, the use of agrochemicals acquires particular relevance for the exercise of agricultural productive activity, a topic on which there are multiple regulations at the national, regional, and international regulatory level (Article 47). Precisely because its regulation is fundamental, within the framework of the agricultural competitiveness of producers on a global scale. In this context, national laws are enacted that introduce, or at least attempt to do so, integrated agri-food and agri-environmental control systems, to guarantee the safety of people, the environment, and plants and animals, and even to avoid excessive contamination of water resources. Without a doubt, the rational use of synthetic pesticides for agricultural purposes promotes the competitiveness of the agricultural sector, and that is why the regulation is inspired by the creation of a balanced and modern registration system. It is a clear example of the effort to give completeness and organization to a large number of scattered norms in the legal system, to respond to the demands of specialized international regulations, both emanating from the World Trade Organization and from Specialized Organizations, the FAO, and the WHO, closely linked with the Codex Alimentarius and with the International Environmental Conventions. That is why the Decree is issued jointly by the Presidency and the Ministers of Agriculture, Health, Environment and Energy, and Economy, Industry and Commerce. It is evident that the phenomenon links the entire agricultural production process, and even the entire prior facet of production, registration, control, and oversight of pesticides used in the agricultural production chain.

VII.- ON THE REDUCTION OF RISKS TO HEALTH AND THE ENVIRONMENT, PURSUANT TO ARTICLE 5 OF THE INTERNATIONAL CODE OF CONDUCT ON THE DISTRIBUTION AND USE OF PESTICIDES. It is of interest to refer to the provisions of the cited International Code of Conduct on the Distribution and Use of Pesticides, which was adopted, for the first time in 1985, by the twenty-fifth session of the conference of the Food and Agriculture Organization of the United Nations (FAO). As explained in the preface to the revised version (adopted by the 123rd session of the FAO Council, November 2002), said code of conduct was adopted and has been revised for the purpose of achieving greater food security while, at the same time, protecting human health and the environment. For such purposes, standards of conduct are established that are to serve as a framework and point of reference for the proper and rational use of pesticides, focusing on risk reduction, protection of human and environmental health, and support for the development of sustainable agriculture through the effective use of pesticides [source: (Source: http://www.fao.org/agriculture/crops/core-themes/theme/pests/pm/code/en/(05/08/11)] In such context, said code of conduct establishes, in its Article 5, the following obligations for governments and the pesticide industry:

"Article 5. Reducing health and environmental risks 5.1 Governments should:

5.1.1 implement a pesticide registration and control system as indicated in Article 6; 5.1.2 periodically review the pesticides marketed in their own country, their acceptable uses, and their availability to each sector of the public, and conduct special reviews when scientific evidence so advises; 5.1.3 carry out a health-monitoring program for people occupationally exposed to pesticides, and investigate and document cases of poisoning; 5.1.4 provide guidance and instructions to health personnel, physicians, and hospital staff for treating suspected cases of pesticide poisoning (25); 5.1.5 establish national or regional information and control centers for poisoning cases in strategic locations, so that they can provide immediate guidance on first aid and medical treatment, and are accessible at all times (25); 5.1.6 use all possible means to collect reliable data and maintain statistics on the health aspects of pesticides and pesticide poisoning incidents, in order to establish the harmonized WHO system for identifying and recording such data (25). They should have properly trained personnel and sufficient resources to ensure the collection of accurate information; 5.1.7 provide extension and advisory services, as well as farmers' organizations, with adequate information on practical IPM strategies and methods and on the variety of pesticide products available for use; 5.1.8 ensure, with the cooperation of the pesticide industry, that, in cases where pesticides are distributed through the same channels as food, clothing, medicines, and other products for consumption or topical application, such pesticides are physically separated from other goods to prevent contamination and/or mistaken identity. Where appropriate, they should be clearly marked as hazardous materials. Every effort should be made to disseminate information about the dangers of storing food and pesticides together (26); 5.1.9 use all possible means to collect reliable data, maintain statistics on environmental contamination, and report specific pesticide-related incidents; 5.1.10 implement a program to monitor pesticide residues in food and the environment.

5.2 Even where a control program is in operation, the pesticide industry should:

5.2.1 cooperate in the periodic re-evaluation of the pesticides marketed; 2.

provide centers that deal with the treatment of pesticide poisoning, and their medical personnel, with information on the hazards related to pesticides and on appropriate treatment; 5.2.3 make every reasonable effort to reduce the risks posed by pesticides:

5.2.3.1 by making less toxic formulations available; 5.2.3.2 by introducing products in ready-to-use packaging; 5.2.3.3 by developing application methods and equipment that minimize exposure to pesticides; 5.2.3.4 by using returnable and refillable containers where effective container collection systems exist; 5.2.3.5 by using containers that are not attractive or easy to reuse and promoting programs that discourage their reuse, where effective collection systems do not exist; 5.2.3.6 by using containers that are not attractive or easily opened by children, particularly for domestic use products; 5.2.3.7 by employing clear and concise labeling; 4. halt the sale and recall products when their handling or use entails an unacceptable risk under any of their use indications or restrictions.

5.3 Governments and industry should also cooperate in reducing risks:

5.3.1 by promoting the use of appropriate and affordable personal protective equipment (5); 5.3.2 by establishing provisions for storing pesticides safely both in warehouses and on farms (26, 27); 5.3.3 by establishing services for the collection and safe disposal of used containers and small quantities of unused pesticides (28); 5.3.4 by protecting biodiversity and minimizing the adverse effects of pesticides on the environment (water, soil, and air) and on non-target organisms.

5.4 To avoid cases of confusion and unjustified public alarm, stakeholders should consider all available data and promote responsible dissemination of information on pesticides and their uses.

5.5 When creating production facilities in developing countries, manufacturers and governments should cooperate to:

5.5.1 adopt technical standards and follow practices appropriate to the nature of the manufacturing operations and the consequent hazards, and ensure the availability of appropriate protective equipment; 5.5.2 take all necessary precautions to protect workers, other persons present, surrounding communities, and the environment; 5.5.3 ensure the appropriate siting of manufacturing and formulation plants and adequate control of their waste and effluents; 5.5.4 maintain quality assurance procedures to ensure compliance with relevant standards of purity, performance, stability, and safety.” VIII.- ON THE REGULATION REGARDING PESTICIDE REGISTRATION. The appropriate use of pesticides can be useful for the control and elimination of pests, for the benefit of the population's food security and economic activity based on agricultural production. However, the potential risk that the use of such substances may pose to human health and the environment must be recognized. This has even led to the adoption of international instruments with the express objective of protecting human health—including the health of consumers and workers—and the environment against the possible harmful effects of pesticides, as is the case of the Rotterdam Convention on the Prior Informed Consent Procedure for Certain Hazardous Chemicals and Pesticides in International Trade, which was approved by Costa Rica through Ley No. 8705 of February 13, 2009. In which case, in response to the mandatory legislative consultation on constitutionality raised before this Tribunal (file number 08-015252-0007-CO), prior to the approval of said international instrument, this Tribunal stated—in relevant part—that:

"(…) the Costa Rican State has the duty to act effectively and in advance to prevent the occurrence of events that degrade the environment and compromise its sustainability. From that perspective, committing, through an international treaty such as the one consulted, or through an internal act, to facilitate the rational use of chemically hazardous products subject to international trade, is not only possible but entirely consistent with its constitutional duties. Pesticides and industrial chemical products are substances that can cause damage to human health and the environment. Faced with such a threat, the Rotterdam Convention provides the Parties with the possibility of knowing in advance the composition and effects of certain chemical products, which are expressly indicated in its Annex III. The appropriate measures that the State takes to regulate the marketing and use of said products in industrial, agricultural, etc. activities are consistent with its duty to preserve the aforementioned values of constitutional rank. Hence, the duties that the State would assume if it were to definitively approve this Convention are legitimate under the Law of the Constitution. This would be a sovereign decision by the State to submit to the obligations contained in the Convention, to contribute to the protection of people's health and the integrity of the environment, so it can be concluded that, in general terms, no constitutional vices are observed in the clauses of the Rotterdam Convention, the approval of which is submitted for consultation." (resolution number 2008-018207 of 6:15 p.m. on December 10, 2008) This verifies that this Tribunal has recognized the risk that the use of pesticides may entail and the importance of adopting appropriate measures to regulate their use. In the Costa Rican legal system, there is diverse legal and regulatory legislation from which it follows that the activity of importing, manufacturing, marketing, and using pesticides is strongly subject to the State's police power, in order to guarantee the right to health and to a healthy and ecologically balanced environment. Firstly, the General Health Law (Ley General de Salud) can be cited, which in its Article 213 provides:

"ARTICLE 213.- Any natural or legal person engaged in producing food must do so under sanitary environmental conditions and using defense or conservation techniques approved by the health authority, in order to mainly avoid the contamination of such products and their hazardousness due to the presence of toxic residues from their treatment with pesticides or other defense or conservation systems." Meanwhile, Article 244 of that same regulatory body establishes:

"ARTICLE 244.- Natural and legal persons who import, manufacture, handle, store, transport, trade, supply, or apply substances, mixtures of substances, or products called pesticides by the plant health law, shall be subject to the regulatory provisions that the Ministry issues in common agreement with the Ministry of Agriculture for the safeguarding of people's health in accordance with that law; interested parties must register every pesticide or product intended for the control or extermination of infestations and request prior permission to operate when such substances, mixtures of substances, or products that, due to their nature or use, are not included in the aforementioned law, are capable in any way of producing poisonings or serious damage to the health of people or of useful or harmless animals to man." For its part, through the Phytosanitary Protection Law (Ley de Protección Fitosanitaria) (Ley No. 7664 of April 8, 1997), the phytosanitary protection measures established in that law and its regulations were declared of public interest and mandatory application (Art. 1). Furthermore, within the objectives of said law is included: "To regulate the use and management of chemical, biological, or related substances and equipment for applying them in agriculture; likewise, their registration, importation, quality, and residues, while seeking at the same time to protect human health and the environment" (Article 2, subsection E). The competent authority in this matter is the State Phytosanitary Service (Servicio Fitosanitario del Estado), which is responsible—among other functions—for: "Controlling chemical, biological, or related substances for agricultural use, regarding their registration, import, export, quality, tolerance, residues, dosages, effectiveness, toxicity, presentation to the public, conservation, handling, trade, general conditions of use, safety, and precautions in transport, storage, elimination of containers and residues of such substances; likewise, controlling the equipment necessary to apply them and any other activity inherent to this matter" (Article 5, subsection O). In accordance with the foregoing, Articles 23, 24, 25, and 30 of said regulatory body provide:

ARTICLE 23.- Registration of substances and equipment.

According to the requirements that will be specified in the regulation of this law, all chemical, biological, or related substances and application equipment for agricultural use must be registered in the registry that the State Phytosanitary Service will create to have information on their characteristics and to ensure their correct use in the country." "ARTICLE 24.- Registration of substances.

No natural or legal person may import, export, manufacture, formulate, store, distribute, transport, repackage, refill, advertise, handle, mix, sell, or use chemical, biological, or related substances for agricultural use, which are not registered in accordance with this law.

Excepted from the indicated registration are chemical, biological, or related substances for agricultural use, which enter in transit, for research, or to combat specific phytosanitary problems. In these cases, the permit will only be granted temporarily for reasons of urgency, technically justified before the State Phytosanitary Service.

The Service shall deny the authorization when it is not technically appropriate and shall notify the interested party." "ARTICLE 25.- Registration of persons.

Any natural or legal person that registers, imports, exports, repackages, and refills chemical, biological, or related substances and application equipment for agricultural use must register in the registry kept by the State Phytosanitary Service, upon prior fulfillment of the requirements set out in the respective regulation.

The Service may deny, suspend, or cancel the registration of chemical, biological, or related substances and of application equipment for agricultural use, by means of a reasoned technical resolution that conforms to due process, in accordance with the respective regulation." "ARTICLE 30.- Prohibitions and restrictions for technical reasons.

The Ministry of Agriculture and Livestock may restrict or prohibit the import, transit, re-routing, manufacture, formulation, refilling, repackaging, storage, sale, mixing, and use of chemical, biological, or related substances and application equipment for agricultural use, when justified for technical reasons and their use is considered harmful to agriculture, health, or the environment." Finally, the Law for the Import and Quality Control of Agrochemicals (Ley para la Importación y Control de la Calidad de Agroquímicos) (Ley No. 7017 of December 17, 1985) states, in its Article 5, that:

"ARTICLE 5.- For the purpose of ensuring the quality and use of agrochemicals, the Ministry of Agriculture and Livestock is obligated to carry out periodic controls on the quality of these products in factories and distribution houses, where it shall take the necessary samples to send them to the quality control laboratory. This Ministry shall also be responsible for the control of chronic toxicity and its effect on the health of people and the environment. No product may be registered without these analyses having been carried out. The Ministry of Agriculture and Livestock may prohibit the circulation or order the destruction of products that do not comply with quality standards, as well as take other measures aimed at improving the quality of agrochemicals. Regarding the elaboration and control of quality standards, the cited Ministry shall act in coordination with the National Office of Standards and Units of Measurement of the Ministry of Economy and Commerce." It follows from the previously cited regulations that, as a manifestation of the referred police power, the necessary registration of pesticides is included prior to authorizing their import, manufacture, marketing, or use, in order to be able to exercise prior control regarding due compliance with the corresponding technical requirements of quality and safety, in protection of public health and the environment." From all of which the following main ideas are extracted that serve as the basis for this note:

*The right to food as a human right imposes food safety and with it requires traceability (trazabilidad) or trackability of the product throughout the entire food chain ("from farm to table"). For this reason, control mechanisms are established for establishments, registration, and listing of agricultural inputs, even establishing agro-environmental liability rules when damages and losses occur to agriculture, the environment, and human and animal health.

*Integrated agri-food and agro-environmental control systems are therefore established to guarantee the safety of people, the environment, and plants and animals, and even to avoid excessive contamination of water resources (recursos hídricos).

*According to the International Code of Conduct on the Distribution and Use of Pesticides, which was first adopted in 1985 by the twenty-fifth session of the Conference of the Food and Agriculture Organization of the United Nations (FAO), standards of conduct are established that should serve as a framework and point of reference for the appropriate and rational use of pesticides, focusing on risk reduction, the protection of human and environmental health, and support for the development of sustainable agriculture through the effective use of pesticides. In addition, see the Rotterdam Convention on the Prior Informed Consent Procedure for Certain Hazardous Chemicals and Pesticides in International Trade, which was approved by Costa Rica through Ley No. 8705 of February 13, 2009.

*The use of pesticides, while it may be useful for the control and elimination of pests, for the benefit of the population's food security and economic activity based on agricultural production, the potential risk that the use of such substances may pose to human health and the environment must also be recognized. Therefore, as a manifestation of the State's police power, the necessary registration of pesticides is included prior to authorizing their import, manufacture, marketing, or use, in order to be able to exercise prior control regarding due compliance with the corresponding technical requirements of quality and safety, in protection of public health and the environment.

Furthermore, constitutional jurisprudence on the principle of progressivity and the principle of non-regression in environmental matters must be recalled.- The principle of progressivity imposes on the State the obligation to gradually increase, to the extent of its possibilities and development, the level of protection of the right to the environment. It is the obligation to continuously develop and execute policies and norms aimed at progressively achieving the full effectiveness of the right to the environment. The principle of non-regression stands as a substantive guarantee of the right to a healthy and ecologically balanced environment, by virtue of which the State is obligated not to adopt measures, policies, or approve legal norms that worsen the situation of rights achieved up to that point (see voto 2016-00415). In this case, it is confirmed that the decree repealed by the decree in question was much more adequate, complete, and rigorous for the entry and control of pesticides. This confirms the regressivity in this matter. Comparing the regulation made by the challenged decree with the previous regulation, the regressivity is evident, and with it, the non-progressivity in the protection of health and the environment regarding regulation on the registration and use of pesticides in our country.

Grave danger to the environment and public health: The great concern that has been expressed about the quality of pesticides that could be released into agricultural fields and the environment is alarming, since, first, IAGTs are registered by equivalence or are revalidated, without the technical information necessary for an assessment of health and environmental risks, which contravenes the recommendations of the OECD (which establishes the need to carry out risk assessment prior to the registration of chemical substances, such as pesticides); and second, by not requiring the submission of biological tests for the registration of formulated products containing unevaluated IAGTs, a lack of knowledge of the effects on humans and the environment is inferred, as well as uncertainty as to whether the product fulfills its pest control function.

Transcendence of the topic in question for human health: The transcendence of the topic at hand must be recalled, since pesticides have a direct impact on human health. Agrochemical and biological substances used in agriculture can represent damage—or risk of violation—. These agrochemicals reach cultivated foods directly, and then, the tables of all consumers. In such a way that agricultural inputs, particularly pesticides, are susceptible to causing irreparable damage to the environment and health, especially if used incorrectly, so the State must issue norms and adopt the necessary measures so that all activity related to agrochemical products, particularly pesticides, conforms to the duty to preserve health and the environment. As the plaintiff mentions, the Human Rights Council of the United Nations General Assembly, through resolution 34/12 (A/HRC/RES/34/12), indicated regarding the right to food, approved on March 23, 2017, in its point 41, "Invites States to promote practices that minimize the potential risks to health and the environment associated with pesticides, while ensuring their effective use." Furthermore, Article 5 "Reduction of risks to health and the environment" of the International Code of Conduct on Pesticide Management, of the FAO and WHO, establishes that governments should implement a pesticide registration and control policy and system in accordance with Article 6, which they transcribe, which indicates policies and legislation, establishing systems and infrastructures so that each pesticide product is registered before it is available, risk assessments and adopting risk management decisions, and applying the principles described in the Manual on the development and use of FAO and WHO specifications for plant protection products, for the purposes of determining equivalence between pesticides.

Violation of the preventive principle, precautionary principle, pro natura principle, and the principle of objectification of environmental protection: The challenged regulation is contrary to what constitutional environmental principles mandate: preventive principle (when there is certainty of possible damage to the environment, the affecting activity must be prohibited, limited, or conditioned upon compliance with certain requirements. In general, this principle applies when there are risks clearly defined and identified as at least probable; likewise, this principle is useful when there are no technical reports or administrative permits that guarantee the sustainability of an activity, but there are sufficient elements to foresee eventual negative impacts), precautionary principle (when there is danger of serious and irreversible damage, the lack of absolute scientific certainty shall not be used as a reason to postpone the adoption of cost-effective measures to prevent environmental degradation. The principle is based on reasonable scientific uncertainty together with the threat of serious and irreversible environmental damage), pro natura principle (in case of doubt or uncertainty, controversies must be resolved and norms must be interpreted in favor of the protection and conservation of the environment), and the principle of objectification of environmental protection (or principle of linkage to science and technique, according to which decisions in this matter must be supported by technical studies, both in relation to acts and provisions of a general nature—both legal and regulatory—from which derives the requirement of "linkage to science and technique," thereby conditioning the Administration's discretion in this matter. It has been defined as principle number 17 of the Rio Declaration on the Environment).

When faced with a situation that requires the application of the precautionary principle, public entities and bodies must refrain from authorizing, approving, or permitting any new or modification request that reasonably implies a serious risk; they are even obligated to suspend activities that are underway, and in parallel they must efficiently adopt all measures required for the preservation of a healthy and ecologically balanced environment. Therefore, the application of the precautionary principle implies that when there are indicators that a certain activity could plausibly cause serious and irreversible damage to the environment, the lack of absolute certainty or scientific evidence in this regard does not exempt from the obligation to adopt all those efficient and effective measures to prevent harm to the environment. Furthermore, in light of the theory of Drittwirkung der Grundrechte, this principle extends its guiding function to the conduct of subjects of both public and private law.

The foregoing is violated by the decree in question. Thus, to further highlight the importance of protecting the right to the environment, health, and food security, and in application of the constitutional environmental principles of progressivity and non-regression, the precautionary principle, the preventive principle, the in dubio pro natura principle, and the principle of objectivization, I have considered recording this note in the terms expressed.

Fernando Cruz Castro VCG12/2023 In support of its argument, it cites opinions numbers C-171-2000, C-255-2009, and C-215-2013 of the Office of the Attorney General of the Republic (Procuraduría General de la República, PGR).

It emphasizes that the decree for updating files and its amendment applies exclusively to all registrations of "technical grade active ingredient" (ingrediente activo grado técnico, IAGT) and formulated products that were registered under a regulation (legal or regulatory) different from Executive Decree No. 33495-MAG-S-MEIC-MINAET, "Regulation on the Registration, Use and Control of Formulated Synthetic Pesticides, Technical Grade Active Ingredient, Adjuvants, and Related Substances for Agricultural Use" (Reglamento sobre Registro, Uso y Control de Plaguicidas Sintéticos Formulados, Ingrediente Activo Grado Técnico, Coadyuvantes y Sustancias Afines de Uso Agrícola). That is, it stresses that it only applies to those product registration files already on the market that were registered according to the regulations applicable at the time of their approval and that were comprehensively evaluated (health, environment, and biological efficacy) under those regulations; therefore, if the petitioner considers that said regulation has legality defects, it must challenge them in the corresponding jurisdictional venue and not in the constitutional venue. It considers unacceptable and improper that the petitioner seeks to discuss legal aspects in the constitutional venue that are not the purview of the constitutional venue but of the ordinary courts.

It argues that the petitioner confuses and seeks to confuse regarding registered agrochemicals currently marketed in the country, which are those to which Executive Decrees No. 39995-MAG and No. 41481-MAG apply, seeking to make it seem that they must be newly evaluated, which is neither proper nor necessary, since all products registered in Costa Rica met the requirements and regulations established in the positive law in force at the time those registrations were granted. Consequently, it clarifies vehemently and repeatedly that for none of the pesticide products, whether raw materials or formulated products with a current registration, is there scientific technical evidence or presumption, or at least indications, that presume an additional hazard resulting from its application regarding human health, the environment, or the biological efficacy of the pesticide. Both the Constitutional Chamber and the PGR have been clear that both the Ministry of Health, the Ministry of the Environment, the Ministry of Agriculture, and even private parties may resort to the ordinary jurisdictional venue to request the annulment of the administrative acts through which those registrations were granted, and may even request that their commercialization be suspended as a precautionary measure. However, neither the Ministry of Health, nor the Ministry of the Environment, nor the petitioner do so because they lack evidence, scientific and technical support, and, for this reason, they recklessly resort to the Constitutional Chamber to raise legality issues through unconstitutionality actions, with the sole purpose and objective of hindering the process of organizing the agrochemical registration system undertaken by the Administration.

It insists that under the mentioned decrees—No. 39995-MAG and No. 41481-MAG—registrations for new IAGT or new formulated pesticides are not being granted, but rather they only apply to old IAGT (raw materials) and formulated products.

It explains that it was as of 2007 that a registration system was established requiring prior registration of the raw material—IAGT. Before that date, it was not necessary to register the IAGT, and that is why the Executive Branch issued the decrees under challenge. It adds that it is not as the petitioner claims, that the challenged rules are facilitating the registration of new products, for the truth is nothing is being facilitated; rather, a window is opened for registration holders to submit confidential chemical information fundamental to ensuring there are no toxicologically and ecotoxicologically relevant impurities in any of the products currently marketed under a current registration granted for an indefinite term. Therefore, it is not correct to assert that by applying these rules, the registrations whose files are updated pose an additional risk to health, the environment, or agriculture, because all the IAGT registrations granted must necessarily and unavoidably correspond to some of the formulations already sold on the market, and over these formulations, the Ministries of Health or Environment have broad and undisputed powers and faculties to adopt the pertinent measures to prevent damage to health or the environment, not only by resorting to the jurisdictional avenue to annul the administrative acts under which the registration was granted, but also by preventing, on a precautionary or interim basis, any act that implies or entails the importation, manufacture, handling, storage, transportation, commercialization, supply, and the use and application of the product considered to damage health or the environment, as the PGR and the Constitutional Chamber itself have repeatedly determined.

It echoes that any granted registration can be revoked or annulled, obviously through the lesivity process, if it is demonstrated that it poses an unacceptable risk to health or the environment, and within that process, precautionary measures can be requested involving the suspension of the importation, commercialization, and use of that pesticide until its registration is annulled; therefore, the radical environmentalists who unsuccessfully filed the amparo appeal and the unconstitutionality action against Executive Decree No. 39995-MAG of December 15, 2016, cannot expect the Chamber to annul the registrations without demonstrating and accrediting the scientific evidence proving the affectation or risk to health or the environment.

It reiterates that the decrees are only applicable to old IAGT and formulated products, that is, those for which registrations were already granted in the country and have been used for many years, use that has allowed certainly knowing their behavior, safety, and efficacy. All are products that already have a registration and therefore can be marketed because they have a current registration, pursuant to the regulations in force at the time of being granted. The registrations were recorded because they met the requirements, procedures, and evaluations established by that regulation in force, for which reason these products are protected by a registration, and that legal situation cannot be ignored by the active administration.

Regarding the application of the precautionary principle in pesticide matters, it invokes PGR Opinion No. C-255-2009 and establishes that the competence of the Ministry of Health and the Ministry of Environment and Energy is maintained, particularly regarding human life and health, and insists on the legality issues already explained. It reiterates that once a specific product is registered, the Public Administration creates a consolidated legal situation, and that in any case, precautionary or annulment measures can be ordered if any affectation to life or health is verified.

It points out that Executive Decree No. 39995-MAG and its amendment No. 41481-MAG allow resolving the problems of disorder, uncertainty, and lack of information in the files supporting the registrations of IAGT and formulated pesticides with current registration, but which were granted under a regulation different from Executive Decree No. 33495-MAG-S-MINAE-MEIC. It considers the questioned regulation to be a major advance and resolves a problem that began in 2004 and had not yet been resolved by previous administrations, as it foresees the alternatives and avenues to resolve the two most serious problems afflicting the registration system of our country: on one hand, the paralysis in the registration of new and generic products, and on the other, the impossibility of renewing the registrations of formulations currently on the market.

It establishes that one of the virtues of the executive decree in question is that it permits the application of the new sanitary products registration regulation, as it standardized the validity of registrations and associated formulations with manufacturers, in relation to previous executive decrees. In this sense, it details that the challenged regulation allows: a) the updating of manufacturers, their origin, production sites of the IAGT associated with formulations already marketed in Costa Rica and that were registered under different legislation; b) the same in relation to formulated pesticides; c) ending the legal uncertainty regarding the validity of IAGT registrations and formulated pesticides that were registered under previous legislation and regulations, standardizing the validity period of ten years for all registrations, thereby ending indefinite validity; equating the registrations of old formulations to the current registration system by granting them the IAGT registration, which eliminates formulations that do not have a properly updated associated one, and organizing and updating the labels and leaflets with which formulated pesticides are being marketed in Costa Rica, such that under the regulation, all label and leaflet changes or modifications are recorded in the physical file of the product.

It states that the regulation in question comes to fulfill some provisions adopted since 2004 that have not been complied with, specifically: 1) that all registrations must have a reasonable validity period and with the decree, all registrations that had been granted for an indefinite period now have a validity of ten years, that is, registrations with indefinite validity are ended; 2) that all chemical information on purity, total impurities, or relevant impurities as well as the synthesis pathway of the technical material used to formulate the pesticide must be contained in the registration file.

It reproaches the petitioner for seeking to hinder the file updating process and not providing documentary or scientific proof, and considers that an enumeration of the violated constitutional rights and guarantees is lacking. It insists that in files 17-005922-0007-CO and 17-002503-0007-CO, an unconstitutionality action and an amparo appeal were filed—respectively—against the executive decree object of this process, and both were rejected, and especially highlights the reasoning of the separate note of Magistrate Hernández López on this matter.

It questions the petitioner's argument regarding the updating process as a reevaluation process, as it indicates that any of the products currently having a current registration can be suspended or annulled if they represent a risk to health or the environment. Furthermore, it argues that the petitioner omits to say that these are products whose IAGT and the formulated product associated with it are already on the market and are not new products requiring evaluation prior to granting them a registration allowing commercialization, such that the petitioner is wrong in making such assertions, and it questions where the petitioner gets the idea that the updating process is a risk reevaluation process for a product already marketed and having a current registration.

It argues that the reports of the Office of the Comptroller General of the Republic (CGR) invoked by the petitioner have been taken out of context, and that they are sought to be applied to a different legal situation. It indicates that in the case of report DFOE-AM-19-2004, the previous decree regulating the matter was in force—namely, 24337-MAG-S of 1995—so the assessments made by the CGR at that time are not applicable:

“Finally, in the background, the petitioner cites a report from the Comptroller's Office, taking it out of context and attempting to apply it to an absolutely different legal situation, and it seems to us that, although it is true it is not a constitutionality issue, we are going to make some clarifications regarding said report and its contextualization. Report DFOE-AM-19-2004 of October 20, 2004, analyzes what was happening with the functioning of the registry and its different processes at that time, as well as the regulations in force at that moment, in this case the Regulation for the Registration, Use and Control of Agricultural Pesticides and Adjuvants (Reglamento para Registro, Uso y Control de Plaguicidas Agrícolas y Coadyuvantes), promulgated by Executive Decree number: 24337-MAG-S of 04/27/95, not in force since 2007, which remained in application for almost twelve years and even transcended the repeal of the Law that gave it origin, this because its legal basis was the Plant Health Law (Ley de Sanidad Vegetal) 6248 of 05/02/78 and not the Phytosanitary Protection Law (Ley de Protección Fitosanitaria). Precisely Executive Decree number: 24337-MAG-S of 04/27/95, which was the one in force at the time the Comptroller's Office audited the registration processes, did not establish a separation of the information files and did not even foresee within the list of requirements the presentation of confidential chemical information, nor did it incorporate equivalence determination of IAGT as a registration modality, hence during the validity of said registration regulation, there was no talk of equivalence, reference profile, confidential information, or test data protection. Regarding the prior evaluation of the impact of pesticides on health and the environment, report DFOE-AM-19-2004 of October 20, 2004, is clear in that it was not being done efficiently, which was logical since the SFE did not have within its structure the departments competent to evaluate the toxicological and ecotoxicological information provided by registrants, and therefore determined that said evaluation should be done by the Ministry of Health and the Ministry of Environment, respectively. The Comptroller's Office also recommended, in the report in question, that a new regulation had to be issued with the support of the Phytosanitary Protection Law, since the law supporting the regulation in force at that time had already been repealed.

One aspect to highlight is that when report DFOE-AM-19-2004 of October 20, 2004, was issued, FAO had not yet prepared (it did so in 2006) the document where IAGT registration was foreseen when no reference profile with referenced information existed. Indeed, the FAO document: AGENDA ITEM NUMBER 12.3A. INTERNATIONAL CODE OF ON THE DISTRIBUTION AND USE OF PESTICIDES: DRAFT GUIDELINES ON DATA REQUIREMENTS FOR THE REGISTRATION OF PESTICIDES, which is from October two thousand six, states the following: ‘In the absence of registered technical products in the country with complete data, the technical grade active ingredients intended to be registered cannot do so by means of equivalence, but rather through the normal procedure (…) For products for which a complete risk assessment has not been conducted in a given country, due to the lack of data and/or failures by the original registrant(s) to provide the complete data set required for a risk assessment, any active ingredient previously registered by the original registrant(s) or subsequent registrants, may be used by the registration authorities of a country as a reference source for equivalence assessment, provided that all chemical information required for registration is available, regardless of the risk assessment not being complete’.” (The underlining does not correspond to the original).

It mentions, furthermore, that said report was issued prior to the enactment of Law No. 8622, which incorporated the Dominican Republic-Central America-United States Free Trade Agreement (CAFTA) into the Costa Rican legal system. Along the same lines, it establishes that when said report was issued, the Food and Agriculture Organization of the United Nations (FAO) had not yet promulgated the Manual on the Development and Use of FAO and WHO Specifications for Pesticides, the principle of non-repetition of studies, a principle incorporated in Considerando XIII of Executive Decree No. 40059-MAG-MINAE-S:

“In said principle, the FAO and the WHO recognize that the repetitive generation of studies and information regarding all potential/real risks for each manufacturer of a pesticide can be unnecessary and ethically undesirable. Obviously, report number: DFOE-AM-19-2004 of October 20, 2004, from the Office of the Comptroller General of the Republic, was issued prior to the entry into force of international agreements on test data protection and before the incorporation of the principle of non-repetition of test data by the FAO and the WHO. (…)

This principle is a fundamental principle in the registration process, not only because it expresses at a regulatory level a thesis, based on science and chemistry, that the generic industry has historically sustained, in the sense that chemical equivalence between two IAGT makes it unnecessary to demand toxicological, ecotoxicological, or environmental fate and behavior studies. This general principle must be observed and complied with by the national authorities; therefore, registrants are empowered to invoke said principle when requesting the exemption of some of the assays or studies established in the Registration Regulation. In this regard, we must remember that unwritten rules (custom, jurisprudence, and the general principles of law) are useful for the interpretation, application, and integration of the written legal system, so that in cases of regulatory insufficiency or gaps, general principles constitute a source of law.” It refutes the aforementioned CGR Report No. DFOE-AM-19-2004, pointing out that in 2013, a reform operated in the FAO's International Code of Conduct on the Distribution and Use of Pesticides, for which reason it considers the report inapplicable. It affirms that said Code promotes that States establish a pesticide registration and control system, and mentions PGR Opinion C-215-2013, which refers to this international standard. It complements the above by indicating that a CGR report cannot grant governmental powers related to pesticide registration to other ministries, and insists that competence in pesticide matters corresponds to the SFE, according to the Phytosanitary Protection Law. It states that the reform operated by Executive Decree No. 41481-MAG on Executive Decree No. 39995-MAG does not allow registering new pesticides—new, according to Art. 15.10 of CAFTA—and that the reform that operates is linked to the modification of administrative deadlines and requirements.

It insists that the MAG, through the SFE, is the competent body for the reception, verification, and evaluation of registration certificates, as a governmental power originating from the Phytosanitary Protection Law, excluding the participation of other bodies such as the Ministry of Health and MINAE:

“As long as the SFE adjusts its structure and has within the Registration Unit the areas of Chemical Evaluation, Toxicological Evaluation, and Ecotoxicological Evaluation, it could not even be insinuated that there is a deterioration in environmental regulations, because, as we have already explained, it was the legislator who, in the Phytosanitary Protection Law, conferred competence on the MAG, through the SFE, to create and administer the registry of agricultural use pesticides, for which reason this deconcentrated body must have a technical, organizational, and administrative structure that ensures not only the quality and efficacy of pesticides but also their safety, so that both the environment and human health are protected, guaranteeing that the use of these substances does not represent unacceptable risks to health and the environment.” Regarding the petitioner's analysis of the articles of Executive Decree No. 41481-MAG of December 10, 2018, it states the following:

Regarding Art. 1 As observed, said text compared to the text without the amendment maintains its scope of application in the sense that this regulation cannot be used to register new pesticides (new according to the concept of Art. 15.10 of CAFTA and Art. 8 of the Law on Undisclosed Information), and the only thing that changes is related to deadlines and one of the administrative requirements. The petitioner objects to the issue of deadlines which, as we reiterate, is a legality matter that must be resolved in another venue and not in the constitutional venue. It is important to make clear that it is the competent authority that determines the deadlines within which certain acts must be performed and the deadlines the administered party must meet for its proceedings under the protection of the rule. It also proceeds to analyze the subject of requirements and even issues an opinion on what, according to the petitioner, the requirements should be, the procedure for evaluating them, and which authorities should intervene in them, which is not only procedurally unacceptable but legally there is a scheme of competences expressly conferred to the MAG and the SFE in Law No. 7664. From the relationship of Articles 23, 24, 25, following and concordant of the Phytosanitary Protection Law, with Art. 11 of the Constitution and numerals 11 and 59 of the LGAP, it can be affirmed that the procedures for reception, verification, evaluation, and issuance of registration certificates constitute a governmental power conferred by the legislator to the MAG through the SFE. Therefore, it considers that in this matter it would be forbidden to confer governmental powers by decree, just as it would be unacceptable from a strictly legal perspective to base, in general laws related to the environment or human health, an executive decree granting competences to the Ministry of Health and MINAE, when the legislator, in a specific law (Phytosanitary Protection Law), already provides not only the body that must exercise those competences, but also by express rule (Art. 23 of the Phytosanitary Protection Law) establishes that the requirements for the registration of chemical, biological, biochemical substances, adjuvants and related substances, and application equipment for agricultural use shall be established in the regulations of the Phytosanitary Protection Law, so it is clear that, in application of the principles of legal hermeneutics, all the rules, requirements, and procedures for registration are those contemplated in the regulation of that law.

Regarding Art. 2 The petitioner merely objects to matters of mere legality and is remiss regarding the alleged unconstitutionalities of the rule it objects to. Even from the pure and simple reading of the text, it is evidenced that the petitioner's affirmation, that registrations are being granted to new products through this regulatory normative, is fallacious. Nor is it true, as the petitioner states, that agronomists are in charge of reviewing chemical information; but beyond the inaccuracies and fallacies incurred by the petitioner, what is evidenced is that its arguments concern administrative aspects and mere legality, which are not for the Constitutional Chamber to resolve but for the ordinary jurisdiction.

Regarding Art.

Regarding the aspects related to timeframes, with an "unacceptable audacity," it refers to institutional workloads, forgetting that what it is raising and submitting to the knowledge of the Chamber is an action of unconstitutionality against a rule issued by executive decree. Thus, it confirms that we are facing a challenge of administrative and purely legality aspects by the claimant in a jurisdictional venue that is not responsible for hearing these matters. It draws attention to the mention made by the claimant about a technical aspect that reveals his profound lack of knowledge in the matter regulated by the challenged decree and, out of respect for science and the registration system, explains very succinctly:

> "As we had already pointed out, in Costa Rica before January 10, 2007, the registration system established that a formulation could be registered without needing a registration of the raw material, that is, of its technical grade active ingredient (IAGT). After that date, it was established that every formulation, prior to being registered, required the registration of its IAGT. This means that currently, an enormous number—around fifteen hundred formulated products—are not associated with a manufacturer. That is why Executive Decree No. 39995-MAG of December 15, 2016, and its reform (Executive Decree No. 41481-MAG of December 10, 2018, published on January 11, 2019, in issue number 8 of the Official Gazette La Gaceta), establish an updating process that will allow the registration system to guarantee that every formulation marketed in the country will be associated with a manufacturer of the IAGT. In such a way that this manufacturer update does not imply that registration is being granted to a new product; rather, through this updating process, the authority will have the necessary information to determine if the technical material with which that formulated product is formulated does not contain relevant impurities and also complies with the international specification that every IAGT must meet for the formulation of pesticides. Therefore, what the claimant indicates regarding the lack of technical or scientific basis and the confusion made with registration under the equivalence modality is incorrect, because what the process proposes is not an equivalence but an update of the information of a current registration of a formulated product that does not have an IAGT manufacturer associated with its registration, recalling that by virtue of Article 3, it is not that a new product is being authorized, but rather a manufacturer is being associated with that formulation that already has a registration and is marketed in the country." The claimant's technical and scientific lack of knowledge on the matter leads him to assimilate the updating process established by Executive Decree No. 39995 and its reform No. 41481-MAG with the registration by equivalence modality established in the Technical Registration Regulation (Decree No. 40059-MAG-MINAE-S). Furthermore, the claimant organization forgets that in Costa Rica, the registration by equivalence modality is based on chemical equivalence, so technical information is not required, as established by the registration by equivalence systems promoted by FAO.

**Regarding Art. 5** When analyzing Art. 5, the claimant confuses the concept of manufacturer with that of formulator, such that the entire hypothesis, objections, and analysis he makes of said norm are not applicable to the legal situation regulated by the formulator update of Executive Decree No. 39995-MAG of December 15, 2016, and its reform No. 41481-MAG.

**Regarding Art. 6** Art. 6 of the challenged decree guarantees, in its current wording, first, that Costa Rica will cease to have registrations with an indefinite term; rather, from the update onward, all registrations of IAGT and formulated products will have a validity of 10 years, imposing the obligation to renew them. It will not be like now, where, being for an indefinite term, they do not have to be renewed due to lacking an expiration date; second, that it will be guaranteed that all formulations currently sold on the market will have an associated manufacturer, unlike now, where the sites and origins of raw material manufacture are unknown; third, that every IAGT used in the country for the formulation of products authorized to be marketed here has accredited its purity and has no relevant impurities above the international specification; fourth, that all IAGTs used in Costa Rica comply with the international conventions signed by Costa Rica (Annex III of the Rotterdam Convention, the Stockholm Convention, or the Montreal Protocol); and fifth, that the SFE will create a database of toxicological, ecotoxicological, and environmental fate information for the technical grade active ingredients that are registered and do not have current periods of test data protection. It is very important for the SFE to have a data bank for molecules that are not new and whose test data are free to use because they have no current protection periods. It is necessary for companies holding toxicological, ecotoxicological, and environmental fate information for technical grade active ingredients that are not new, to provide information they have managed to compile. This will enable the SFE to gradually build a complete toxicological, ecotoxicological, and environmental fate and behavior profile for use as a reference profile for registrations by equivalence.

**Regarding Art. 7** The current text bears no relationship or congruence with the reckless comments and statements made by the claimant about this specific article. Regarding the assertion that this norm inverts the burden of proof principle or the precautionary principle, it is rejected "absolutely and categorically," not only because it is a matter of legality to be discussed in the ordinary jurisdiction, but also because the current text of Art. 7 is supported by reiterated opinions of the PGR and by rulings of the Constitutional Chamber. It considers that it is incorrect and reckless to maintain, as the claimant does, that the questioned decree violates the precautionary principle in environmental matters, just as it is incorrect to indicate that the burden of proof is inverted.

It points out that the norm under action does not allow or make possible the granting of registrations for new products to those already marketed. This is because its scope of application is very clear and is only feasible to apply to current registrations granted under regulations (legal or reglementary) different from Executive Decree No. 3495-MAG-SMINAE-MEIC and its reforms. That is, "it is not feasible to register new IAGTs or new formulations with new IAGTs." The IAGTs that are granted, necessarily and unfailingly, with this regulation will not grant registrations for IAGTs, much less for formulations that are not already on the market. Regarding the agrochemicals registered and currently marketed in the country, there is no additional danger resulting from their application concerning human health, the environment, or the biological efficacy of the pesticide. Therefore, it is not correct to state that with the application of the decree, the registrations whose files are updated pose an additional risk to health, the environment, or agriculture, since all—absolutely all—the IAGT registrations granted, necessarily and unfailingly, must correspond to some of the formulations already sold on the market. Regarding these formulations, the Ministries of Health or Environment have broad and indisputable powers and faculties to adopt the pertinent measures to prevent harm to health or the environment, not only by resorting to the jurisdictional route to annul the administrative acts under which the registration was granted, but also by even precautionarily or provisionally preventing any act that implies or entails the importation, manufacture, handling, storage, transport, commercialization, supply, and use and application of the product considered harmful to health or the environment. Certainly, the challenged regulation is only applicable to products that have already been granted a registration and can, therefore, be marketed. All those products to which the decree under analysis applies were registered because they met the requirements, procedures, and evaluations established by the regulations in force at the time their registration was granted. Thus, these products are protected by a registration, and this registral legal situation cannot be ignored by the active Administration. On this, the PGR was already clear and forceful in opinion number C-255-2009 by affirming that the pesticide registrations (IAGT or formulated) that currently have current registration are therefore authorized to be marketed in the country. The foregoing proves that there is no violation of the precautionary principle in environmental matters, nor is the burden of proof principle being inverted. This is because, being products that are marketed and protected by a registration, it means that the product already met the requirements and procedures established by the regulations in force and was also evaluated according to those regulations by the competent authorities. Therefore, it is clear and indisputable that the active Administration must respect this legal situation and the administered party's right. Thus, to annul the act that conferred it, it must follow the procedures set by the Contentious-Administrative Procedural Code, aimed at declaring the harmful nature and annulment of the registration act, being able, even as a precautionary measure, to prevent—while the harmful nature is declared—the importation, manufacture, handling, storage, transport, commercialization, supply, and use and application of the product considered harmful to health or the environment.

**Regarding Art. 11** The claimant provides nothing more than a transcription of parts of a report from the controlling entity, absolutely decontextualized and not applicable to the specific situation. The homologation of formulations proposed in Art. 11 of the challenged decree is based on the FAO and World Health Organization (WHO) Manual on the development and use of specifications for pesticides.

Subsequent to the preceding particular analysis of the challenged norms, it reiterates the attribution of competence in matters of registration of agrochemical substances that various legal and regulatory norms assign to the MAG through the SFE and, in this regard, provides transcriptions of opinions from the PGR and rulings from the First Chamber of the Supreme Court of Justice.

**Regarding the claimant's conclusions** The regulation under examination applies only to old products; that is, products for which registrations of IAGT or formulated product have already been granted, and many of these registrations were granted for an indefinite term. This means they do not require the updating decree to continue being marketed. Therefore, rather than facilitating, it concerns imposing an obligation on them to update their information and provide data and studies that certify not only the provenance and origin of the technical materials and associated formulations, but also to provide the confidential chemical information allowing the registration authority, the SFE, to have at its disposal the confidential chemical information on purity, impurities, synthesis method, etc., of their technical materials, concerning both manufacturers and formulators. This confidential chemical information demonstrates whether the IAGT has impurities of toxicological or ecotoxicological relevance that may affect health or the environment. This information is not currently held in the registrations that must be updated.

Depending on the relevant impurities and their concentration, the registration authority can make regulatory decisions regarding the continuation or not of a registration or a manufacturer of a technical material for a formulation marketed in Costa Rica.

The claimant maintains or implies, without supporting it, that every manufacturer of IAGT must provide their own test data; that is, that each manufacturer must conduct chronic, subchronic toxicological studies, ecotoxicological studies, and environmental fate and behavior studies. Thus, it seeks to obligate the manufacturers of IAGT used in the formulation of pesticides to carry out these studies (the claimant does not explain why the same is not required of manufacturers of active ingredients used in human medicines). This claim outlined by the claimant is absolutely censurable by FAO and the WHO, as both international organizations, in the Manual on the Development and Use of FAO and WHO Specifications for Pesticides, have incorporated the principle of non-repetition of studies, a principle incorporated in Recital XIII of Executive Decree No. 40059-MAG-MINAE-S.

Nor is it true that technical materials and registered formulated products have never been evaluated, as the claimant recklessly states in his conclusions; all registered products were registered after verifying that they met the requirements established by the regulations in force. The MAG and the SFE cannot, as the claimant intends, disregard this legal situation and the rights of the administered parties.

The technical, philosophical, and legal foundation of both Executive Decree No. 39995-MAG and its reform No. 41481-MAG of December 10, 2018, is found in the recital and legal part of both norms. In this case, the Phytosanitary Protection Law No. 7664, whose objective is to regulate the use and management of chemical, biological, or related substances and equipment to apply them in agriculture; likewise, their registration, importation, quality, and residues, simultaneously seeking to protect human health and the environment. All of these must be registered in the registry that the SFE will create to have information available on their characteristics and to ensure their correct use in the country.

It is essential to guarantee supply and continuity in the commercialization of products that currently have a current registration, making it necessary to update the information in their files on their characteristics and ensure their correct use in the country. The decree itself indicates in its recitals that the regulations prior to the entry into force of Executive Decree No. 33495 MAG-S-MINAE-MEIC of October 31, 2006, and its reforms allowed the MAG to grant registrations for an indefinite term as well as the registration of formulated pesticides without requiring prior registration of the IAGT, which obliges the Executive Branch, within its constitutional and legal powers, to organize its registry, ordering the update of information for registrations registered for an indefinite term, having been granted under prior regulations.

The questioned norms aim to update the files with information that was not requested at the time of their registration, through a re-registration process in accordance with Art. 50 of the Constitution.

**The importance of Executive Decree No. 39995-MAG and its reform, Executive Decree No. 41481-MAG** From the technical and scientific point of view: It allows the State to have all the information on purity, relevant impurities (name, content, and detection levels), total impurities, synthesis method, analytical methodologies to determine the IAGT and its relevant impurities, for all IAGTs registered as such or as components of a formulation, which were registered in Costa Rica under legislation and norms different from Executive Decree No. 33495-MAG-S-MEIC-MINAET. The confidential chemical information required by this decree is key and essential from the agronomic, toxicological, and ecotoxicological point of view, and unfortunately, it is not incorporated into the files of these registrations. Much of the chemical information requested in the decree, especially that described in Arts. 1 and 5, although presented during the revalidation process, is completely outdated, as between 5 and 10 years have passed since the information was provided, and the authorities have not yet reviewed, much less approved it. It allows the Costa Rican State to have updated information on formulation sites and origins, the name and physical location of formulators, as well as the components of the product and a detailed description of the formulation processes for all formulated products currently marketed in Costa Rica.

From the chemical and scientific point of view: It guarantees that no formulated pesticide marketed in Costa Rica can be registered and therefore marketed if it does not have an associated IAGT with levels of relevant impurities (those of toxicological and ecotoxicological importance) exceeding the levels specified in international reference standards (FAO, EPSA, IUPAC).

From the legal point of view: It manages to equate old registrations (those not registered under Executive Decree No. 33495-MAG-S-MEIC-MINAET) with registrations granted under the registration system (which establishes registration of the IAGT as a prerequisite for the registration of a formulation). Consequently, all currently registered formulations will have their corresponding associated IAGT (with its current manufacturer, its origin, and production or synthesis site), duly registered. The information in the technical dossier is absolutely congruent, not only with the principle of non-repetition of studies promoted by FAO and the WHO, but also with doctrine and comparative law. It grants legal certainty to registrants and agricultural producers regarding the supply of formulated products marketed today. It constitutes the legal instrument that allows the application of the new registration regulation, by standardizing the validity of registrations and by associating formulations with their IAGT's current manufacturer and the product's current formulator (national or foreign).

From the political point of view: Another novelty and benefit of the regulation for updating files is that it will solve a problem that past administrations have not managed to solve, despite attempts to do so through transitional decrees (change of manufacturer) and revalidation processes. In Costa Rica, a very high percentage (perhaps 80% or 85%) of the formulations marketed do not have the respective IAGT associated with their registration, which not only leaves the protection of health and the environment in a state of vulnerability but also does not allow registrants to improve their formulations or register new ones. This is overcome with the new regulation. Now, with this decree, the problem of formulations lacking an associated IAGT registration is solved, giving great merit to the current administration, as the regulation for updating registration files constitutes a legal instrument of high political value. It resolves the problem and uncertainty (technical and legal) facing registrations that had been granted under regulations of various ranks, different from that established by Executive Decree No. 33495-MAG-S-MEIC-MINAET. Through this new decree, the mechanisms are empowered and arranged for the authority to have technical and chemical information that guarantees that currently marketed pesticides do not pose an unacceptable risk to agriculture, health, or the environment.

From the agronomic point of view: It organizes and updates the labels and leaflets with which the formulations are marketed in Costa Rica, so that the factors involved in the use of a formulated pesticide—namely, the concentration of the technical grade active ingredient in the formulation, the application doses, the period and number of treatments, the use of adjuvants, and the application methods and places that determine the amount applied, the treatment frequency, and the pre-harvest interval—as well as all factors inherent to the mode of use of a formulated pesticide. All of this is a faithful reflection of the product's file.

It requests that the appeal be declared without merit.

**4.-** The edicts referred to in the second paragraph of Art. 81 of the Constitutional Jurisdiction Law (LJC) were published in numbers 84, 85, and 86 of the Judicial Bulletin, on May 08, 09, and 10, 2019.

**5.-** By a document received at 10:05 hrs. on May 10, 2019, **Julio Alberto Jurado Fernández** appeared to respond to the hearing granted to the **PGR**, and stated the following:

**Regarding standing** The party has standing to file the unconstitutionality action, as it appears in defense of diffuse interests, related to Arts. 21 and 50 of the Political Constitution.

**Regarding the merits** The object of this constitutional process is closely related to a similar one, processed under file 18-19039-0007-CO, so the accumulation of this process to the one previously indicated is suggested.

Before Executive Decree No. 33495 of 2006 was issued, registering a formulated pesticide did not require prior registration of the technical grade active ingredients required for that formulation, and registrations were granted without a defined term, nor were the same technical requirements demanded. As a result of the foregoing, Executive Decree No. 33495 established a revalidation process, so that holders of IAGT registrations, granted before the promulgation of said regulation, would provide the SFE with the necessary information to sustain the validity of their registrations. Subsequently, Law No. 8702 was enacted, establishing a revalidation process similar to the aforementioned decree. Executive Decree No. 33495 was repealed with the issuance of Executive Decree No. 40059—object of another unconstitutionality action, processed under file 18-009107-0007-CO.

Afterwards, Executive Decree No. 39995 was issued, which established another revalidation process for the registration of pesticides, subject to a deadline. Before this deadline elapsed, Executive Decree No. 41841 —the object of this unconstitutionality action— was issued, which extended the revalidation deadline to sixty months from its publication. The recitals of said decree explain that the SFE suspended the application of Executive Decree No. 39995 in response to a query from the SFE's internal audit to the PGR and that “due to a lack of procedure, it has not been possible to update the information for any of the registrations of technical grade active ingredients (ingredientes activos grado técnico, IAGT) and formulated products that do not have an IAGT registration and that were not registered in accordance with Executive Decree No. 33495”. In addition to modifying the deadline set forth in Article 1 of Executive Decree No. 39995, some requirements and procedural aspects of said decree are varied, apparently based on the sixth recital, which provided: </span></p><p style=\"margin-top:0pt; margin-left:28.35pt; margin-bottom:0pt; text-align:justify\"><span style=\"font-family:'Times New Roman'; font-style:italic\">“That technical grade active ingredients are used solely for the formulation of synthetic chemical formulated pesticides and only by exception are they used directly in the field, and these exceptional situations are already regulated in the current technical regulations; therefore, the registration certificates for technical grade active ingredients are only useful for authorizing, by the State Phytosanitary Service, the importation of these as raw materials for pesticide formulations in processing plants and not for their direct use in the field”.</span></p><p style=\"margin-top:0pt; margin-bottom:0pt; text-align:justify; line-height:150%; font-size:14pt\"><span style=\"font-family:'Times New Roman'; -aw-import:spaces\">&nbsp;</span></p><p style=\"margin-top:0pt; margin-bottom:0pt; text-align:justify; line-height:150%; font-size:14pt\"><span style=\"font-family:'Times New Roman'; font-weight:bold; text-decoration:underline\">Regarding the constitutionality analysis of the challenged norm</span></p><p style=\"margin-top:0pt; margin-bottom:0pt; text-align:justify; line-height:150%; font-size:14pt\"><span style=\"font-family:'Times New Roman'\">As stated in the report for action No. 18-19039-0007-CO, the Procuracy is not competent to assess strictly technical aspects and determine whether the requirements and information listed by the challenged norm are adequate or not for conducting a correct assessment of the environmental and health risk of pesticides; therefore, in that aspect, the constitutionality analysis must take into account the technical information submitted to the case file.</span></p><p style=\"margin-top:0pt; margin-bottom:0pt; text-align:justify; line-height:150%; font-size:14pt\"><span style=\"font-family:'Times New Roman'\">In the report for action No. 18-19039-0007-CO, the Procuracy noted that in the revalidation process of Decree No. 33495, certain technical requirements were demanded that were not contemplated by Decree No. 39995, even though the recitals of the latter acknowledge that it concerns the updating of products that have not met the toxicological, ecotoxicological, and environmental fate information requirements set forth in international regulations and required since the entry into force of Decree No. 33495. Therefore, based on the foregoing, it was indicated that, if the technical reports submitted to the case file confirm the above and show that there are no technical criteria justifying the content of the norm and determining that with the required requirements it is not possible to carry out an adequate assessment of the environmental and health risk, the principle of non-regression of environmental law (principio de no regresión ambiental) and the principle of objectification of environmental protection (principio de objetivación de la tutela ambiental) would be violated, because the levels of environmental and health protection provided by Decree No. 33495 would be diminished, without a study supporting the adoption of that measure. Furthermore, it was argued that the preventive principle (principio preventivo) would be infringed, since, by not requiring information that allows for an adequate assessment of the environmental and health risk of the products, it is not possible to adopt measures aimed at avoiding, mitigating, or correcting the adverse effects that pesticides generate on the environment. And that this would even imply a violation of the precautionary principle (principio precautorio), since, without an adequate review of the health and environmental risk of pesticides, there would be no scientific certainty that they do not cause harm to the environment.</span></p><p style=\"margin-top:0pt; margin-bottom:0pt; text-align:justify; line-height:150%; font-size:14pt\"><span style=\"font-family:'Times New Roman'\">In this case, it must first be assessed what the technical basis of Decree No. 41481 is that motivated the extension of the revalidation deadline for five more years and that justifies the possibility of continuing to market pesticides, even though they have not complied with the revalidation process and their effects on health and the environment have not been determined.</span></p><p style=\"margin-top:0pt; margin-bottom:0pt; text-align:justify; line-height:150%; font-size:14pt\"><span style=\"font-family:'Times New Roman'\">The formulation of a query to the Procuracy, contrary to what is indicated in the recitals of the decree, does not suspend the application of the norms that are the object of the query. And, therefore, the query raised by the internal auditor of the SFE regarding several questions related to Decrees Nos. 39461, 40059, and 39995-MAG, which gave rise to Opinion No. C-199-2017, did not imply the suspension of the revalidation process established by Decree No. 39995.</span></p><p style=\"margin-top:0pt; margin-bottom:0pt; text-align:justify; line-height:150%; font-size:14pt\"><span style=\"font-family:'Times New Roman'\">Likewise, it must be technically assessed whether the requirements set forth by the challenged norm for the revalidation process allow for an adequate assessment of the environmental or health risk of the products, since, from a mere comparison of the texts of Decree No. 39995 and Decree No. 41841, it is verified that the technical requirements that Decree No. 33495 did contemplate were not added, but rather, some points were eliminated and modified.</span></p><p style=\"margin-top:0pt; margin-bottom:0pt; text-align:justify; line-height:150%; font-size:14pt\"><span style=\"font-family:'Times New Roman'\">For example, in Article 1, acute toxicity studies and ecotoxicity studies that Decree No. 33495 contemplated are still not required, and these are required only for cases where the manufacturer has changed and the product presents relevant impurities, which is determined according to international reference specifications and standards. Moreover, in Article 1.1, the request for manufacturer update, the registration certificate issued by the authority of the country of origin, and the endorsement of a chemist for the qualitative-quantitative composition certificate were eliminated. In Article 1.2, the registration certificate issued by the authority of the country of origin was eliminated and the way of indicating the chemical name in the analytical certificate of active ingredient composition was varied; and in Article 5, the certificate of country of origin and the chemist's endorsement of the qualitative-quantitative composition certificate and the certificate of analysis of the formulated product were eliminated, while the possibility of accrediting, through an affidavit (declaración jurada) of the registration holder, that the formulation composition has not varied and that an authorized active ingredient is used, is maintained.</span></p><p style=\"margin-top:0pt; margin-bottom:0pt; text-align:justify; line-height:150%; font-size:14pt\"><span style=\"font-family:'Times New Roman'\">Subject to what is provided in the technical criteria that are submitted, if it is confirmed that the challenged norm lacks technical basis and that it relaxes requirements and extends the revalidation process deadline, preventing a correct evaluation of the effects of pesticides and allowing their commercialization under those terms, the Procuracy considers that the unconstitutionality action should be granted. Unless, as recommended in case file No. 18-19039-0007-CO, the Chamber considers that the challenged decree does not weaken the SFE's powers to require any other pertinent and necessary information to conduct an adequate evaluation that allows determining that the use of the product does not affect health or the environment, as has been indicated on other occasions. </span></p><p style=\"margin-top:0pt; margin-bottom:0pt; text-align:justify; line-height:150%; font-size:14pt\"><span style=\"font-family:'Times New Roman'\">In that same sense, the unconstitutionality of Article 2 must be declared if, based on the technical criteria submitted to the case file, it is determined that the reduction of the deadline from three months to one month, for the SFE to verify and analyze the submitted information and resolve the product update application and grant the registration certificate, prevents an adequate assessment of the environmental and health risk of the product from being carried out. Notwithstanding what is resolved regarding that article, it is advisable for the Constitutional Chamber to clarify whether the rule that the figure of positive silence (silencio positivo) does not apply in the case of environmental approvals or authorizations is applicable, and that, therefore, the Administration's failure to comply with the established deadline would not imply the automatic approval of the product's revalidation.</span></p><p style=\"margin-top:0pt; margin-bottom:0pt; text-align:justify; line-height:150%; font-size:14pt\"><span style=\"font-family:'Times New Roman'; font-weight:bold; text-decoration:underline\">Regarding the possibility of registering products using referenced information</span><span style=\"font-family:'Times New Roman'\">, the Procuracy, in the report rendered in case file No. 18-19039-0007-CO, considered that should it be confirmed that there is no technical support and that with the type of information required it is not possible to carry out an adequate assessment of the environmental and health risk, the articles that contemplate that possibility would be unconstitutional, for violating the principles of objectification of environmental protection, preventive principle, and precautionary principle. </span></p><p style=\"margin-top:0pt; margin-bottom:0pt; text-align:justify; line-height:150%; font-size:14pt\"><span style=\"font-family:'Times New Roman'\">Furthermore, it noted the ruling No. 16937-2011 that declared unconstitutional subsection b) and the reference in the penultimate paragraph to said subsection b) of section 7.3.2 of Article 2 of Executive Decree No. 33495, insofar as it allowed registration by equivalence of technical grade active ingredient products using other registrations that did not have complete information as a reference profile, since for the registration of the latter, in addition to acute toxicity and ecotoxicity studies, additional chronic toxicology studies, ecotoxicological studies, and other studies on the abiotic environment were not required, as demanded by Article 5 of the Law for the Import and Quality Control of Agrochemicals (Ley para la Importación y Control de la Calidad de Agroquímicos) and the FAO and WHO Manual on the Development and Use of Specifications for Pesticides (which is applicable according to the provisions of Article 44 of the Phytosanitary Protection Law and Article 6.1.7 of the International Code of Conduct on the Distribution and Use of Pesticides of the FAO).</span></p><p style=\"margin-top:0pt; margin-bottom:0pt; text-align:justify; line-height:150%; font-size:14pt\"><span style=\"font-family:'Times New Roman'\">Based on the foregoing, although the Procuracy is not a technical body in the matter, it can be indicated that even though the challenged decree modifies Articles 1.2.b and 6 of Decree No. 39995 that allowed registering products using referenced information, it maintains that possibility, since in Article 1.2.c it allows the use of international specifications to certify that the technical material intended to be updated does not contain relevant impurities, indicating in the fifth recital that international specifications and standards are a technical and scientific reference for determining that technical grade active ingredients do not contain relevant impurities at levels above international standards or specifications, and that only those relevant impurities are those that have toxicological or ecotoxicological relevance that could cause harm to health or the environment.</span></p><p style=\"margin-top:0pt; margin-bottom:0pt; text-align:justify; line-height:150%; font-size:14pt\"><span style=\"font-family:'Times New Roman'\">In that same sense, Article 3 provides that formulated pesticides that do not have an associated technical grade active ingredient registration will be granted that registration directly when the manufacturer of that active ingredient has been updated. </span></p><p style=\"margin-top:0pt; margin-bottom:0pt; text-align:justify; line-height:150%; font-size:14pt\"><span style=\"font-family:'Times New Roman'\">Article 6 provides that upon fulfilling the requirements, the registration will be granted for 10 years and that, during that period, the SFE will verify that already approved registrations of technical grade active ingredients have chemical equivalence with the reference profile of that active ingredient and that, in the absence of that profile, it must be verified that they do not contain relevant impurities. </span></p><p style=\"margin-top:0pt; margin-bottom:0pt; text-align:justify; line-height:150%; font-size:14pt\"><span style=\"font-family:'Times New Roman'\">Article 11 endorses the homologation of labels and pamphlets with those of other already registered products that have the same active ingredient and the same concentration, without contemplating the effects that the other components of the product or the form or method of preparation could have.</span></p><p style=\"margin-top:0pt; margin-bottom:0pt; text-align:justify; line-height:150%; font-size:14pt\"><span style=\"font-family:'Times New Roman'\">The challenged norm does not establish how the information will be verifiable, how to determine which international specification can be used, the way to determine the equivalence of products, nor whether the reference profile to be used must be a registration that has complete information, and therefore, that covers acute toxicity, ecotoxicity, chronic toxicology, ecotoxicological studies, and other studies on the abiotic environment as required by Article 5 of the Law for the Import and Quality Control of Agrochemicals and the FAO and WHO Manual on the Development and Use of Specifications for Pesticides.</span></p><p style=\"margin-top:0pt; margin-bottom:0pt; text-align:justify; line-height:150%; font-size:14pt\"><span style=\"font-family:'Times New Roman'\">By not precisely establishing the rules to which the competent authority must adhere to verify the information, it is possible to allow the updating of registrations with referenced information that does not meet the indicated requirements, and, therefore, this would imply the updating of product registrations without a prior assessment of the environmental and health risks of their application.</span></p><p style=\"margin-top:0pt; margin-bottom:0pt; text-align:justify; line-height:150%; font-size:14pt\"><a name=\"_Hlk124940539\" class=\"\"><span style=\"font-family:'Times New Roman'\">If the foregoing is verified, according to the technical criteria issued for that purpose, this would imply the unconstitutionality of the articles that allow the use of referenced information without an adequate determination of equivalence.</span></a></p><p style=\"margin-top:0pt; margin-bottom:0pt; text-align:justify; line-height:150%; font-size:14pt\"><span style=\"font-family:'Times New Roman'; font-weight:bold; text-decoration:underline\">Regarding the exclusion of MINAE and the Ministry of Health from the registration update process</span><span style=\"font-family:'Times New Roman'\">, the Procuracy indicated that the revalidation process regulated by Decree No. 33495 provided that the competent institutions could request additional information, and this suggests that the participation of those Ministries was included. Therefore, it was considered that the non-participation of the corresponding technical departments of those ministries in the process established by Decree No. 39995 implies a regression in the level of protection and a violation of the principle of objectification of environmental protection, as it would allow the updating of registrations without having the technical opinion of those dependencies within their field of competence.</span></p><p style=\"margin-top:0pt; margin-bottom:0pt; text-align:justify; line-height:150%; font-size:14pt\"><span style=\"font-family:'Times New Roman'\">The same must be said of the challenged decree, insofar as it carries that same defect by not including the participation of those Ministries, unless the Chamber considers that the powers attributed to other bodies in their respective creation laws are not repealed or modified by the challenged norm and that the SFE, within the exercise of its legal powers, can and must require the participation of any specialized technical body to verify that a pesticide does not threaten health and the environment.</span></p><p style=\"margin-top:0pt; margin-bottom:0pt; text-align:justify; line-height:150%; font-size:14pt\"><span style=\"font-family:'Times New Roman'; font-weight:bold; text-decoration:underline\">Regarding the improper reversal of the burden of proof (carga de la prueba) that, in the plaintiff's opinion, is contemplated by the reformed Article 7</span><span style=\"font-family:'Times New Roman'\">, the Procuracy reiterates that this does not weaken the constitutional duty that, by virtue of the precautionary principle, the competent authorities have to apply the powers set forth in Articles 25 and 30 of the Phytosanitary Protection Law and Article 5 of the Law for the Import and Quality Control of Agrochemicals, to “deny, suspend or cancel the registration of chemical, biological or related substances”, “restrict or prohibit the importation, transit, re-routing, manufacturing, formulation, repackaging, repacking, storage, sale, mixing and use of chemical, biological or related substances and application equipment for agricultural use, when justified for technical reasons” and to “prohibit the circulation or order the destruction of products that do not comply with quality standards, as well as take other measures aimed at improving the quality of agrochemicals”.</span></p><p style=\"margin-top:0pt; margin-bottom:0pt; text-align:justify; line-height:150%; font-size:14pt\"><span style=\"font-family:'Times New Roman'\">In conclusion: The analysis of this unconstitutionality action involves assessing whether the defects attributed to Decree No. 39995 in unconstitutionality action No. 18-19039-0007-CO have been remedied in the challenged decree, or if, on the contrary, they persist or are aggravated.</span></p><p style=\"margin-top:0pt; margin-bottom:0pt; text-align:justify; line-height:150%; font-size:14pt\"><span style=\"font-family:'Times New Roman'; font-weight:bold\">6.- </span><span style=\"font-family:'Times New Roman'\">By brief received at this Constitutional Chamber at 18:42 hrs. on May 20, 2019, Mr. </span><span style=\"font-family:'Times New Roman'; font-weight:bold\">Jaime Enrique García González</span><span style=\"font-family:'Times New Roman'\">, doctor in agricultural sciences and professor in the Agriculture and Environment Area of the Environmental Education Center of the Universidad Estatal a Distancia, specialist in pesticides, files a joinder (coadyuvancia) in this process. He proceeds to propose documentary evidence, consisting of resolution 153-2014-VI of the Contentious-Administrative Tribunal, as well as resolution 1030-2018 of the First Chamber of the Supreme Court of Justice. </span></p><p style=\"margin-top:0pt; margin-bottom:0pt; text-align:justify; line-height:150%; font-size:14pt\"><span style=\"font-family:'Times New Roman'; font-weight:bold\">7.- </span><span style=\"font-family:'Times New Roman'\">Through a brief received at 11:04 hrs. on May 29, 2019, Mr. Jorge </span><span style=\"font-family:'Times New Roman'; font-weight:bold\">Arturo Osborne Escalante</span><span style=\"font-family:'Times New Roman'\">, identity card no. 1-0417-1413, in his capacity as legal representative of the Association National Chamber of Banana Growers (“CANABA”, hereinafter), with legal entity identification number 3-002-056468, proceeds to appear in this process as a passive coadjuvant. Regarding his standing, he argues that it derives from CANABA's purpose, which is the defense of its associates' interests, linked to banana activity in the country. He considers that he has a legitimate interest, derived from the use of pesticides to control pests and diseases in the cultivation and commercialization of bananas. He claims that the associates of said association use registered pesticides as part of their commercial activity and that this allows them to maintain their productivity and exports, hence he believes he has sufficient legitimate interest to participate as a passive coadjuvant in this process. On the other hand, he believes the plaintiff lacks active standing, since he does not indicate how Executive Decree No. 41481-MAG affects him and indicates that the certification of legal representation provided does not verify the date of issuance, so he believes it should not have been admitted. Regarding what the plaintiff calls the objective of the action, CANABA's legal representative says the brief contains a series of allegations that lack foundation. He argues that now an obligation is imposed to update information and provide data and studies regarding technical materials and formulations made, as well as the delivery of confidential information to the SFE. In this, he partially coincides with the MAG report, in the sense that it is the law that mandates the issuance of the executive decree in question, for establishing requirements and procedures for the registration of chemical, biological, and biochemical substances. He mentions Opinion C-175-2005 of the PGR. Regarding the background, he refutes the plaintiff's assertions, since the executive decree subject to this action does not seek to grant more time to the business sector for the commercialization of agrochemicals. He considers that, rather, obligations to update information are imposed on these companies. He states that this is not a case of concurrent jurisdiction between the MAG, the Ministry of Health, and MINAE, since Law No. 7664 grants jurisdiction regarding pesticide registration to the SFE. He adds that report DFOE-AM-19-2004 is inapplicable, contrary to what the plaintiff asserted. He reiterates what was said by the MAG, regarding the so-called principle of non-repetition of studies and that the dispute should be resolved in the venue of legality and not of constitutionality. He reproduces the argument sustained by said ministerial body to the effect that the decree subject to this process does not allow granting registrations for new products, as well as the argument of the consolidation of the legal status derived from the registration. He rejects the assertions made by the plaintiff through the conclusions present in the filing brief. He requests that the unconstitutionality action be dismissed. He provides as documents the MAG report already indicated, as well as the legal status of the association in question. </span></p><p style=\"margin-top:0pt; margin-bottom:0pt; text-align:justify; line-height:150%; font-size:14pt\"><span style=\"font-family:'Times New Roman'; font-weight:bold\">8.- </span><span style=\"font-family:'Times New Roman'\">Through a brief received at 13:22 hrs. on May 29, 2019, Mr. </span><span style=\"font-family:'Times New Roman'; font-weight:bold\">Juan Rafael Lizano Sáenz</span><span style=\"font-family:'Times New Roman'\">, identity card no. 1-0379-0262, in his capacity as president of the Cámara Nacional de Agricultura y Agroindustria (CNAA), legal entity number 3-002-051316, presents a passive joinder in this process. After recounting the factual background, he indicates that his standing as a coadjuvant comes from the purpose of the CNNA, which groups producers, businessmen, and entities from the agricultural and agro-industrial sector. He states that the association includes different associates from various actors in the agricultural sector, and that precisely from there comes his standing, since his commercial activity involves the registration and application of pesticides. He indicates that the process affects the interests of the different groups that make up said association, which confirms the sufficient legitimate interest for purposes of admitting the passive joinder. After reiterating the plaintiff's arguments, he proceeds to begin his exposition regarding the inadmissibility of the unconstitutionality action. Firstly, he alludes to the fact that the reform carried out through Executive Decree No. 41481-MAG was conducted in compliance with what was stipulated in technical and scientific studies, according to international standards. Regarding the opinion of other bodies such as the PGR and MINAE, he indicates that this Constitutional Chamber cannot assess strictly technical matters and cites in his favor resolution No. 7009-2019. He insists that in the case of assessing the validity of technical and scientific studies in environmental matters, the proper course is to discuss it in a venue other than the constitutional one and invokes resolutions Nos. 6922-2008 and 7009-2019. He claims that such assessments are beyond the summary remedy of amparo. On the other hand, he alludes to the power granted by various legal, regulatory, and constitutional norms to the Executive Branch in the strict sense for the promulgation of executive decrees and, given that these norms grant authority to the MAG, they do so excluding other bodies, so he rejects the arguments of the plaintiff. He requests that the joinder be admitted and that the present unconstitutionality action be dismissed on the merits. He attaches the certification of his legal representation. </span></p><p style=\"margin-top:0pt; margin-bottom:0pt; text-align:justify; line-height:150%; font-size:14pt\"><span style=\"font-family:'Times New Roman'; font-weight:bold\">9.- </span><span style=\"font-family:'Times New Roman'\">By brief received at 14:50 hrs. on May 29, 2019, Mr. </span><span style=\"font-family:'Times New Roman'; font-weight:bold\">Federico Lizano González</span><span style=\"font-family:'Times New Roman'\">, identity card no. 1-0793-0229, in his capacity as legal representative of the Cámara de Insumos Agropecuarios de Costa Rica, legal entity number 3-002-045217, proceeds to file a passive joinder in this process. Regarding his standing as a coadjuvant, he argues that his represented party is an organization made up of companies from the sector supplying inputs and technology for the agricultural sector, hence the validity of Executive Decree No. 41481-MAG directly affects the interests of the Chamber and its affiliates. This is because its associates carry out registration procedures for agricultural inputs and indicate that what this Constitutional Chamber resolves directly affects the work of the Chamber and its associates. Regarding the merits of the case, he considers that the action should be dismissed. He mentions that the regulatory power held by the Executive Branch has constitutional status, and that it is not subject to any limits other than legal regularity and the reservation of law. On the other hand, he claims that registrations by incorporation and by equivalence are based on the rationalization of state intervention; resorting to this information obtained from high standards does not endanger the environment or health. He argues that the decree in question refers to products that are already on the market and that have already been duly evaluated. Regarding the reduction of deadlines, he considers that said norm is not contrary to constitutional Law, as it is framed within the context of regulatory improvement and better public service delivery. He requests that the joinder be admitted and that the present unconstitutionality action be dismissed in all its aspects. </span></p><p style=\"margin-top:0pt; margin-bottom:0pt; text-align:justify; line-height:150%; font-size:14pt\"><span style=\"font-family:'Times New Roman'; font-weight:bold\">10.- </span><span style=\"font-family:'Times New Roman'\">By brief received at 14:40 hrs. on May 29, 2019, Mr. </span><span style=\"font-family:'Times New Roman'; font-weight:bold\">Manrique Constela Umaña</span><span style=\"font-family:'Times New Roman'\">, in his capacity as unlimited general power of attorney for Polymer S.A., presents a passive joinder in this constitutionality process. To support his standing as a coadjuvant, he indicates that the company is dedicated to the production of plastic packaging for industry, agriculture, and personal consumption.

It states that the legitimate interest in relation to this action derives from the fact that they frequently must request the registration or revalidation of agrochemical or agrobiological products. As to the merits of the matter, they request that the unconstitutionality action must be summarily rejected, as they do not consider that it meets the admissibility requirements. They believe that the interest pursued by the complaining party is individual and direct and that they are not truly acting in defense of the environment or the right to health. They mention that the complainants are actually seeking to challenge rules they deem contrary to their economic interests and cite various resolutions of the Constitutional Chamber in defense of their arguments, including resolution No. 8470-2007. They consider that the plaintiff lacks active standing in this proceeding and that it must therefore be summarily rejected. On the other hand, they maintain that the brief lacks adequate substantiation because it proceeds to reiterate the arguments already made in the proceeding processed under case file 18-19039-0007-CO. In another line of reasoning, they suggest that this proceeding be consolidated with the one being processed in that case file and indicate that the challenged rules should not be suspended, as the complaining party requested. The brief then addresses the constitutionality of the rules in question. First, it reiterates what has already been said about the constitutional assignment of regulatory power to the Executive Branch, which it supports with doctrinal citations. It points out that in accordance with Law No. 7664, the MAG is responsible for regulating said law, due to the organizational and technical structure it must have. It explains the scope of the principle of legality and its relationship with jurisdiction, based on doctrine and opinions of the PGR, applying the foregoing to jurisdiction in phytosanitary matters and under the terms of the Phytosanitary Protection Law. It indicates that the SFE has the technical expertise to develop its powers related to the control of chemical, biological, or related substances for agricultural use. It notes that only the MAG has the authority to issue an adequate opinion on the registration or revalidation of products for agricultural use. It dismisses the complainant's reproaches that the decree under review benefits producers, as it rather considers that it conforms to the principles of public service, for which it brings up Art. 4 of the LGAP and resolution 5600-2005 of this Constitutional Court. It mentions that the reduction of timeframes in no way implies favoritism toward agrochemical sales companies; on the contrary, it is due to the technical criterion held by the SFE, in accordance with the principles of effectiveness, efficiency, and speed. It complements this argumentation by applying Law No. 8220. It believes that the reduction of timeframes is not contrary to the fundamental rights of health and environmental protection, which it supports with jurisprudence of this jurisdictional body. This brief indicates that the elimination of requirements is not unconstitutional, as it points out a lag in the technical regulations in question, stemming from what it considers a poor conception of environmental and health protection. It explains the difference between formulated pesticide and technical-grade active ingredient (ingrediente activo grado técnico), as well as the distinction between registration by incorporation (registro por incorporación) and registration by equivalence (registro por equivalencia) and alleges that the decree in question does not eliminate requirements necessary for the protection of health or the environment, but rather establishes rational regulations consistent with the significant public utility derived from the registration of agrochemical products. It requests that the action be summarily rejected and, should this request not be granted, that it be consolidated with case file No. 18-19039-0007-CO. It also requests that the unconstitutionality action be declared without merit in all its aspects, as well as an interpretation of the decree in question in conformity with the Political Constitution, should the Constitutional Chamber deem that the application of the decree in question violates constitutional rules and principles.

**11.-** The Presidency of the Constitutional Chamber, through the resolution issued at 3:48 p.m. on May 30, 2019, resolved the matters concerning the joinders:

*“In the specific case, the petitioner Enrique García González appeared on May twenty, two thousand nineteen, however, he failed to prove his interest in appearing as a coadjuvant in the present matter, hence his request cannot be accepted, in accordance with the provisions of Article 83 of the Law on Constitutional Jurisdiction.* *On the other hand, the coadjuvants Constenla Umaña, Osborne Escalante, Lizano González and Lizano Saénz, appeared on May twenty-nine, two thousand nineteen and requested to be considered as coadjuvants because they believe that the outcome of this unconstitutionality action could potentially affect their commercial activities. Consequently, and given that the first publication of the notice was on May eight, two thousand nineteen, the appropriate course is to accept them as coadjuvants in this matter.”* Likewise, the hearings granted to the PGR and the MAG were deemed answered.

**12.-** By brief signed on August 27, 2019, the Minister of Agriculture and Livestock, **Luis Renato Alvarado Rivera,** requested clarification of the order issued at 2:45 p.m. on April 8, 2019, concerning the effects on the administrative procedures for updating registration files. Likewise, he insists on the following:

*“We must not omit to inform the Honorable Chamber that the challenged rule does not refer to new registrations to be granted, but to an update of the information in current registrations, which were granted in the past, after having undergone evaluation by the ministries of Agriculture and Health. Furthermore, it does not refer to products that were first authorized in Costa Rica on a global scale, but rather those that had already been comprehensively evaluated (in agronomic, health, and environmental aspects) and approved by regulatory entities in their countries of origin, such as the United States of America, the European Union, Japan, among others.* *The update proposed in the challenged rule rather serves to organize the national regulatory system, as it mandates updating the origin information in the files of the current registrations.”* **13.-** By a brief filed on November 1, 2019 (without the corresponding signature), Mr. Henry José Picado Cerdas, identity card No. 3-0403-0272, in his capacity as an interested citizen, proceeds to request an appearance in the present proceeding.

**15.-** The procedural requirements of law have been fulfilled.

Drafted by Magistrate **Garro Vargas;** **WHEREAS** **I.- ON THE LAST JOINDER PETITION** A memorial received at the Secretariat of the Chamber on November 1, 2019, presented a document lacking a signature, supposedly subscribed by Mr. Henry José Picado Cerdas, identity card No. 3-0403-0272. He merely stated that, in his capacity as an interested citizen, he requested an appearance in the present proceeding. This petition is inadmissible for several reasons. As already noted, the document lacks a physical or digital signature to corroborate the validity of the petition in a proceeding that is formal in nature, such as an unconstitutionality action. Secondly, the party does not set forth the grounds motivating his desire to appear in the proceeding, and finally, should this be considered a joinder petition, it was filed untimely. Therefore, the petition is rejected.

**II.- ON THE ADMISSIBILITY OF THE UNCONSTITUTIONALITY ACTION. STANDING** On this point, it must be noted that Article 75, paragraph 2 of the Law on Constitutional Jurisdiction (LJC), establishes that a prior pending case is not necessary when, due to the nature of the matter, there is no individual and direct injury, or when it involves the defense of diffuse interests, or interests that concern the community as a whole. In this regard, the Constitutional Chamber, in its judgment No. **2001-8239**, referred to diffuse interests in the following terms:

*“According to the first of the cases provided for by the 2nd paragraph of Article 75 of the Law on Constitutional Jurisdiction, the questioned rule must not be susceptible to concrete application, which would later allow the challenge of the applicative act and its subsequent use as a base case. (...) Secondly, the possibility of acting in defense of diffuse interests is provided for (...) Diffuse interests, although difficult to define and even more difficult to identify, cannot be in our law – as this Chamber has already stated – purely collective interests; nor so diffuse that their ownership merges with that of the national community as a whole, nor so concrete that determined persons, or personalized groups, are identified or easily identifiable against them, whose standing would derive, not from diffuse interests, but from corporate ones that concern a community as a whole. They are, therefore, individual interests, but at the same time, diluted in more or less extensive and amorphous groups of people who share an interest and, therefore, suffer an actual or potential harm, more or less equal for all, so it is rightly said that they are equal interests of the groups that find themselves in certain circumstances and, at the same time, of each one of them. That is, diffuse interests partake of a dual nature, as they are simultaneously collective – for being common to a generality – and individual, and thus may be claimed in such capacity. (...) In summary, diffuse interests are those whose ownership belongs to groups of people not formally organized, but united by a certain social need, a physical characteristic, their ethnic origin, a certain personal or ideological orientation, the consumption of a certain product, etc.”* In the present matter, the complainant claims standing via abstract constitutional review and invokes the defense of diffuse interests, as they act to safeguard the right to a healthy and balanced environment and the right to health of the population, related to the registration of pesticides that have evident impact on these. Consequently, this circumstance grants the petitioner direct standing to file this proceeding, by invoking the defense of interests concerning the national community as a whole.

For the foregoing reason, the hearing and resolution of this unconstitutionality action via abstract review are admissible.

**III.- ON THE OBJECT OF THE ACTION** This action aims to resolve the claims of unconstitutionality raised against Executive Decree No. 41481-MAG, entitled “Reforma Reglamento para la actualización de la información de los expedientes de registro de ingrediente activo grado técnico y plaguicidas formulados” (Reform Regulation for updating information in registration files for technical-grade active ingredient and formulated pesticides). Due to the length of the rule, its full content is not cited here; rather, the provisions will be transcribed and the claims will be addressed specifically in the corresponding whereas clause.

In general terms, it is argued that the decree implies a benefit to pesticide marketers, as it extends the period to five years without said products needing to undergo a risk assessment. It is argued that this type of decree only seeks to give more time to agrochemical sales companies to continue with the process of marketing and using substances that are dangerous and that may cause serious harm to the health of the Costa Rican population, affect biodiversity, and damage the environment, because the registrations have not been comprehensively evaluated. In other words, that the products in question lack chronic toxicology studies, none of these registrations have had ecotoxicological assessment performed, and many might not be effective at the doses for which they were registered. Furthermore, that the decree lacks technical substantiation on pesticide matters and seeks to make requirements more flexible, to the detriment of the life and health of individuals. The issue of the timeframes established for the submission and resolution of petitions is questioned, as well as the exclusion of the authorities of the Ministry of Health and MINAE from the process.

Previously (see judgment **No. 2022-026651**), this Chamber took note that new executive decrees were issued during the pendency of this action that could have an impact on the validity of these regulations. Specifically, Executive Decree No. 43469 of April 6, 2022, “Reglamento técnico RTCR 504:2021. Reglamento para el Registro de Insumos Agrícolas. Plaguicidas Sintéticos Formulados, Ingrediente Activo Grado Técnico, Coadyuvantes, Sustancias afines y Vehículos Físicos de Uso Agrícola” (Technical Regulation RTCR 504:2021. Regulation for the Registration of Agricultural Inputs. Formulated Synthetic Pesticides, Technical-Grade Active Ingredient, Adjuvants, Related Substances, and Physical Vehicles for Agricultural Use) established two transitional provisions stating that the Executive Branch will enact a new specific technical regulation governing the updating of registrations:

*“**TRANSITORIO 5. ** The Executive Branch, within six months from the date this regulation enters into force, shall enact a specific technical regulation governing the updating of registrations of technical-grade active ingredient and formulated synthetic pesticides, granted based on a regulatory framework different from this regulation, Executive Decree No. 33495 MAG-S-MINAE-MEIC 'Reglamento sobre Registro, Uso y Control de Plaguicidas Sintéticos Formulados, Ingrediente Activo Grado Técnico, Coadyuvantes y Sustancias Afines de Uso Agrícola' or Executive Decree No. 42769-MAG-S-MINAE 'Reglamento para optar por el Registro de Ingrediente Activo Grado Técnico mediante el reconocimiento de la evaluación de los estudios técnicos aprobados por las Autoridades Reguladoras de los países miembros de la OCDE y los países adherentes de la OCDE'. This technical regulation must at least consider the requirements, procedures, prioritization of the updating, timeframes according to the capacities of the AC and the competent reviewing authorities, as well as the technical establishment of reference profiles for the evaluation of all products that were registered under regulations different from those cited.”* The registrant may make reference to information already submitted in prior processes of revalidation, update, or renewal when applicable.

**TRANSITORIO 6.** Registrations granted based on a regulatory body other than this regulation, Executive Decree No. 33495 MAG-SMINAE-MEIC "Reglamento sobre Registro, Uso y Control de Plaguicidas Sintéticos Formulados, Ingrediente Activo Grado Técnico, Coadyuvantes y Sustancias Afines de Uso Agrícola" or Executive Decree No. 42769-MAG-S-MINAE "Reglamento para optar por el Registro de Ingrediente Activo Grado Técnico mediante el reconocimiento de la evaluación de los estudios técnicos aprobados por las Autoridades Reguladoras de los países miembros de la OCDE y los países adherentes de la OCDE", must carry out the update in accordance with the regulation established for these purposes pursuant to transitorio 5. These registrations shall be considered effective for a period of five years from the entry into force of this regulation. Said period shall be understood as extended for an equal period for the procedures that have been submitted for the update in accordance with the regulation indicated in transitorio 5 if, at the expiration of this period, the competent reviewing authorities have not yet finalized the review of the update procedures.

Additionally, it is noted that by means of Executive Decree No. 43838-MAG-S-MINAE, a technical regulation was properly issued called “RTCR 509:2022. Insumos Agrícolas. Plaguicidas Sintéticos Formulados, Ingrediente Activo Grado Técnico, Coadyuvantes, Vehículos Físicos y Sustancias Afines de Uso Agrícola. Registro” published in the Official Gazette La Gaceta No. 253, Alcance No. 278 dated December 21, 2022 (https://www.imprentanacional.go.cr/pub/2022/12/21/ALCA278_21_12_2022.pdf), in which it was ordered to derogate Executive Decree No. 39995-MAG of December 15, 2016, “Reglamento para la actualización de la información de los expedientes de registro de ingrediente activo grado técnico y plaguicidas formulados" and its amendment, published in Alcance No. 10 of January 16, 2017” (amended by Decree No. 41481-MAG, the subject of this action). Said regulation will take effect as of March 21, 2023, so the derogation will become effective at that time. Consequently, the constitutionality challenges remain in force.

**IV.- ON PHYTOSANITARY PROTECTION, CONSTITUTIONAL ROOTS** First of all, it is worth emphasizing that phytosanitary protection measures have roots in our Social State of Law, as they seek to simultaneously safeguard values of great constitutional significance: health (Art. 21), the protection of consumer rights specifically to health and the environment (Art. 46), as well as the stimulation of agricultural production of such importance for our country in parallel with the protection of the environment (Art. 50), and such were the constitutional principles that the legislator took into consideration when enacting the Ley de Protección Fitosanitaria. This has been recognized by this Court in multiple rulings. For example, in judgment No. 2009-013606, the Chamber made the following considerations:

"Article 1 of the Ley de Protección Fitosanitaria clearly states: 'The phytosanitary protection measures established in this law and its regulations are declared to be of public interest and mandatory application.' Said law addresses principles and fundamental needs for the stability of the country, such as food security and economic activity based on agricultural production. This finds foundation in several articles of our Political Constitution. Thus, in accordance with Article 50, 'the State shall procure the greatest well-being for all inhabitants of the country, organizing and stimulating production and the most adequate distribution of wealth.' Furthermore, according to this norm, it must guarantee, defend, and preserve every person's right to a healthy and ecologically balanced environment, for which the law shall determine the corresponding responsibilities and sanctions. On the other hand, from Article 21 of the Political Constitution, which enshrines the inviolability of human life, the right to health, to the physical, mental, and social well-being of individuals, and the State's obligation to protect them emerges (Constitutional Chamber, Voto No. 3705-93 of 15 hours on July 30, 1993). Likewise, Article 46 in fine enshrines the right of all consumers and users to the protection of their health, environment, safety, and economic interests. Such were the constitutional principles that the legislator took into consideration when enacting the Ley de Protección Fitosanitaria, No. 7664 of April 8, 1997. Among its main objectives are to avoid and prevent the introduction and spread of pests, to protect plants from the damages caused by them, to regulate their combat, to promote integrated pest management within sustainable development programs, to regulate the use and handling of chemical, biological, or related substances and the equipment to apply them in agriculture, as well as to prevent phytosanitary measures from constituting an unnecessary obstacle to international trade (Article 2).

The Law provides a special procedure for addressing phytosanitary emergencies that may compromise the country's food security and economy, and grants the Administration certain powers to adopt all those measures that allow the control of a situation of that nature. If it is the constitutional duty of the State to organize national production, it is also, consequently, its duty to design mechanisms for the control of pests that may negatively affect it, for which various techniques are used such as the declaration of quarantines, the destruction of plants, the control of entry and in the country of origin of plants or biological control agents, integrated pest management, among others. In this sense, pest combat must be a shared effort between the State and the private parties involved in a situation of this nature. However, if in the face of a specific situation the private party does not comply with the guidelines issued by the State's Servicio Fitosanitario for the combat of a pest, the Administration not only may but is obliged to substitute for it and execute the control work that is necessary and that allows the timely containment of existing infection foci. Now, that conduct by the Administration should not generate any patrimonial liability for it, as it is motivated precisely by the omission of the private party, who is the first one called to combat the infectious situation in accordance with the instructions issued for that purpose by the Servicio Fitosanitario. This is the reason that justifies the exemption from liability established by the challenged Article 15. The protection of public order is above individual interest, but it is the negligence of the private party that justifies that, although the Administration's action causes it damage of exceptional intensity, there is no legal basis to claim any indemnification from the State, especially considering that this negligence may not only affect it but may also compromise the well-being and the general interest of society.

The negligence and omission of the private party therefore oblige the Administration to deploy its police power in order to protect the social public interest. When we speak of 'police power' in a broad sense, we refer to that set of measures aimed at protecting public safety, morality, and health, as well as the defense and promotion of the economic interests of the community and its general well-being. It manifests itself, in principle, as a power attributed to the legislative branch and is therefore non-delegable. However, the legislator may create in ordinary law an imputation of functions, assigning to the executive branch, for example, the power to enact regulations on certain matters, within the limits pre-established by law; such is what occurs in the present case. The Ley de Protección Fitosanitaria grants the Executive Branch, through the Ministry of Agriculture and Livestock, the necessary powers to control potential sources of infection and/or pests." (The highlighting does not correspond to the original).

Along the same lines, this Court has been aware that the chemical components for containing pests in agricultural products have a clear and notable impact on the environment (soil saturation and fertilization), but also on food security (access to food), and, therefore, it is necessary for the State to assume a proactive and vigilant conduct in the matter. Indeed, the State has the obligation to regulate the use of chemical or related substances for agricultural use, so that they are handled correctly, reasonably, and so that they do not generate risks to human health and the environment. Furthermore, it has the responsibility to guarantee the well-being of the inhabitants and an ecologically balanced environment.

In judgment no. 2021-019096, the following was resolved:

"VI.- ON THE REGULATION OF THE USE OF PESTICIDES. As indicated above, the right to life, to health, and to a healthy environment are fundamental rights regulated in Articles 21 and 50 of the Political Constitution, and their protection is in the public interest. Precisely, it is for this reason that the State has the obligation, in order to protect the health of the population, and the environmental precautionary principle, to regulate the use of chemical or related substances for agricultural use, so that they are managed correctly, reasonably, and do not generate risks to human health and the environment. Furthermore, it also has the responsibility to guarantee the well-being of citizens and an ecologically balanced environment. Regarding this, the Chamber has established that the State must have a guarantor role concerning the adequate use of pesticides (plaguicidas) and the avoidance of their harmful effects on health and the environment. In this sense, in Judgment No. 2004-13968 of 11:35 a.m. on December 3, 2014, it indicated:

'III.- That report [FOE-AM-19/2004 of October 20, 2004, prepared by the Agricultural Services and Environment Area of the Operational and Evaluative Oversight Division of the Comptroller General of the Republic, on the evaluation of the State's management regarding the control of agricultural pesticides (plaguicidas agrícolas)] originated from the need to oversee the administrative process related to one of the most pressing environmental problems that the country must resolve, which is the use of chemical, biological, or related substances in agricultural activities, and given the need for the State to intervene by exercising a regulatory function over the use of agrochemicals (agroquímicos), guaranteeing farmers the availability on the market of effective products for pest control and, at the same time, the protection of the health of the general citizenry and their right to a healthy and ecologically balanced environment. The report indicated that this control is exercised mainly by the Ministry of Agriculture and Livestock (Ministerio de Agricultura y Ganadería), through the State Phytosanitary Service (Servicio Fitosanitario del Estado), which must work in coordination with the Ministry of Health (Ministerio de Salud) and the Ministry of Environment and Energy (Ministerio del Ambiente y Energía), regarding the control of impacts on health and the environment, as well as with the Ministry of Finance (Ministerio de Hacienda) regarding the import and exoneration of such products. Its general objective was to evaluate the State's management regarding the control of pesticides (plaguicidas) used in agricultural activities and their effect on the environment and human health, mainly the actions of the State Phytosanitary Service (Servicio Fitosanitario del Estado) of the Ministry of Agriculture and Livestock (MAG); and the specific objectives of the study were: a) to evaluate national policies and stewardship in the field of control over the use of pesticides (plaguicidas), identifying the participating institutions and their competencies, b) to evaluate the process of registration of pesticides (plaguicidas) in the country and the associated regulations, c) to evaluate the exoneration and import process of pesticides (plaguicidas) in the country, and d) to evaluate the oversight and monitoring of the use of pesticides (plaguicidas).

IV.- In that report, the Comptroller General concluded that the State Phytosanitary Service (SFE) does not fulfill its creation objectives with efficiency and adherence to the principle of legality, which call upon it to regulate, execute, and oversee the registration and use of agrochemicals (agroquímicos), within the framework of agricultural activity in harmony with nature and with faithful compliance with the constitutional principles of the right to life, to health, and to a healthy environment. It determined that, to the contrary, the actions of said body are oriented towards facilitating the registration and commercialization of such substances, justified by a supposed interest in improving the competitiveness of agricultural producers, but rather, those objectives seem to be directed at promoting competition in the pesticide (plaguicidas) market, above the constitutional rights of the farmers themselves and the environmental and human health principles. It concluded that the companies most benefited by the facilitating function of the SFE have been the companies dedicated to the sale of agrochemicals (agroquímicos), especially so-called generics, to the detriment of producers and consumers of agricultural goods. It clarified that this does not mean that this type of pesticide (plaguicidas) cannot be registered in the country, but rather that their registration must be done respecting the regulations and ensuring the protection of the health of the Costa Rican population and their fundamental right to a healthy and ecologically balanced environment, and protecting the national farmer's right to have good quality inputs; without prejudice to the necessary actions that the State must execute to seek the gradual reduction of the use of pesticides (plaguicidas) and the promotion of alternative mechanisms. These considerations prompted the Comptroller General of the Republic to issue a series of final provisions directed to the President of the Republic and the Ministers of National Planning and Economic Policy, Agriculture and Livestock, Health, Environment and Energy, and Economy, Industry and Commerce, as well as to the Internal Auditor of the Ministry of Agriculture and Livestock.' " Likewise, in Judgment No. 2006-09565, of 4:08 p.m. on July 5, 2006, this Court considered:

"(…) it is evident that the Costa Rican State has the duty to act effectively and in advance, to avoid the occurrence of events that degrade the environment and compromise its sustainability." And, in No. 2011-016937 of 2:36 p.m. on December 7, 2011, it ordered:

"(…) VIII.- ON THE REGULATION REGARDING THE REGISTRATION OF PESTICIDES. The appropriate use of pesticides (plaguicidas) can be useful for the control and elimination of pests, benefiting the population's food security and the economic activity based on agricultural production. However, the potential risk that the use of such substances can imply for human health and the environment must be recognized. This has even motivated the adoption of international instruments with the express objective of protecting human health—including the health of consumers and workers—and the environment against the possible harmful effects of pesticides (plaguicidas), as is the case of the Rotterdam Convention on the Prior Informed Consent Procedure for Certain Hazardous Chemicals and Pesticides in International Trade, which was approved by Costa Rica, through Law No. 8705 of February 13, 2009.

(…) this Court has recognized the risk that the use of pesticides (plaguicidas) can entail and the importance of adopting suitable measures to regulate their use. In the Costa Rican legal system, there is diverse legal and regulatory framework from which it is derived that the activity of importation, manufacture, commercialization, and use of pesticides (plaguicidas) is heavily subjected to the police power of the State, in order to guarantee the right to health and to a healthy and ecologically balanced environment." (Considerations that were reiterated in judgment no. 2021-024807).

Echoing these constitutional principles, legal regulations declared of public interest by the legislator have been issued to address this important matter. For example, the aforementioned Phytosanitary Protection Law (Ley de Protección Fitosanitaria) in Art. 1 provides that "the phytosanitary protection measures established in this law and its regulations" are declared "of public interest and mandatory application"; the General Health Law (Ley General de Salud) (declared of public interest in Art. 7) also contains general provisions regarding the management of these substances; and the Law on the Use, Management and Conservation of Soils (also of public interest by virtue of the provisions expressly stated in Arts. 3 and 61 of the law) includes provisions and competencies in favor of MINAE regarding activities that may cause soil contamination (see Art. 28 et seq.).

In this way, a very broad sphere of action for the Costa Rican State is observed regarding the use of agrochemicals (agroquímicos), which includes regulating both the use and management of chemical, biological, or related substances and equipment to apply them in agriculture, as well as their registration, importation, quality, and waste, while at the same time seeking to protect human health and the environment.

Regarding the object of this unconstitutionality action, the issue of the "registration" of products is of particular interest, which is regulated in more detail in Arts. 23, 24, and 25 of the Phytosanitary Protection Law. These establish registration and listing, as one of the control mechanisms for establishments and inputs for agricultural use. Specifically, and of particular relevance to this unconstitutionality action, Art. 23 of the law states the following:

"Art. 23 - Registration of substances and equipment According to the requirements that will be set forth in the regulation of this law, all chemical, biological, or related substances and application equipment for agricultural use must be registered in the registry that the State Phytosanitary Service (Servicio Fitosanitario del Estado) will create to have information on the characteristics of these and to ensure their correct use in the country." As will be examined below, the regulations subject to this action respond precisely to this obligation of the State, entrusted to the SFE, to keep the registry of substances used for agricultural purposes updated.

V.- BACKGROUND IN THE CONSTITUTIONAL JURISDICTION The matter submitted for analysis has been examined from different angles by this Court.

In judgment no. 2017-06668, on the constitutionality of Executive Decree No. 39995-MAG (which was later reformed by the decree subject to this action), the following was resolved:

"ON THE MERITS. ABOUT THE ALLEGED VIOLATION OF THE RIGHT PROTECTED IN ARTICLE 50 OF THE POLITICAL CONSTITUTION, RELATING TO A HEALTHY AND ECOLOGICALLY BALANCED ENVIRONMENT. The plaintiff alleges the violation of the right protected in Article 50 of the Political Constitution, specifically, the precautionary and inversion of the burden of proof principles in environmental matters, given that, on one hand, the regulation discussed requires the Administration to demonstrate the existence of an unacceptable risk to human health, the environment, or agriculture, in order to restrict or prohibit the registration of an active ingredient (ingrediente activo) and formulated pesticides (plaguicidas formulados), despite the scope of the aforementioned principle and, on the other, the fact that, according to the contested regulation, it is the responsibility of the Administration, not the holder of the activity, to prove the existence of a risk to the mentioned legal interests, when the principle in question demands the opposite. In this regard, Article 7 of Executive Decree No. 39995-MAG, Regulation for Updating Information in Registration Files for Technical Grade Active Ingredient (ingrediente activo grado técnico) and Formulated Pesticides (plaguicidas formulados) (which is, fundamentally, what the plaintiff is challenging), stipulates the following:

"ARTICLE 7. During the validity period of a registration, when the competent Ministries demonstrate an unacceptable risk to human health, the environment, or agriculture, the State Phytosanitary Service (Servicio Fitosanitario del Estado) shall restrict or prohibit its use." The norm, per se, aims to protect the environment and human health, because it precisely seeks to restrict or prohibit the use of a valid registration when there is an unacceptable risk; consequently, far from harming these constitutional interests, it protects them. The appropriate time to apply the precautionary principle is when proceeding to the registration of an active ingredient (ingrediente activo) or pesticide (plaguicida). It can be assumed that during that registration procedure, a circumstance may arise where there is some technical or scientific doubt about the product's impact on human health, the environment, or agriculture. At that processing stage, the precautionary principle can be applied, that is, that in the face of doubt, the administration must decide not to register something. The contested regulatory norm, that is, Article 7, refers to a subsequent stage to this, since it assumes that the registration procedure has already been substantiated, concluded, and the registration already exists. Consequently, to annul a previously processed registration, the demonstration of an unacceptable risk is indeed required. On the other hand, as already indicated, the norm is protective of human health and the environment, for which it contemplates an imperium power of the public administration such as the restriction or prohibition of the use of a registration, even though a prior substantial legal situation exists in favor of the administered party, such as the registration.

IV.- ON THE VIOLATION OF THE PROVISIONS IN ARTICLE 146 OF THE POLITICAL CONSTITUTION. Nor does the Constitutional Chamber believe that the omission of the Minister of Health and the Minister of Environment to sign the Decree implies a vice of unconstitutionality of the questioned regulation, given that, as the plaintiff acknowledges, the contested Decree has been issued, jointly, by the President of the Republic and the Minister of Agriculture; with this, no affectation of the provisions of Article 146 of the Political Constitution is observed, despite what the plaintiff claims on this point. By virtue of the foregoing, the action must also be rejected on the merits, as far as this point is concerned." (The highlighting is not from the original).

These considerations are especially significant for the specific case, as they make it clear that to annul an already authorized registration, it must be justified that there is a demonstration of an unacceptable risk to human health and the environment. Likewise, it was emphasized that the omission of the Minister of Health and the Minister of Environment to sign the decree does not imply a vice of unconstitutionality of the questioned regulation.

Subsequently, in judgment no. 2017-007766, the following was resolved:

"III.- SPECIFIC CASE. Prior to the resolution of this amparo appeal, it must be stated that the purpose of the amparo appeal is to provide timely protection against infractions or threats to fundamental rights and freedoms, not to serve as a generic instrument to guarantee the principle of constitutional supremacy or the principle of legality. For this reason, the Chamber cannot, through this means, establish itself as an abstract controller of the constitutionality of infra-constitutional norms. Hence, according to numeral 30 paragraph a) of the Law governing this jurisdiction, amparo is not appropriate in this case against laws or other normative provisions, except when they are challenged jointly with the acts of individual application of those, or when dealing with norms of automatic application, in which case the procedure regulated in numerals 73 and following of the Law of the Constitutional Jurisdiction must be followed. According to the recently mentioned assumptions, amparo is not appropriate in this case.

IV.- NOTE FROM JUDGES CRUZ CASTRO AND RUEDA LEAL. By means of Resolution No. 2017006668 of 10:50 a.m. on May 10, 2017, an unconstitutionality action against Executive Decree No. 39995-MAG, Regulation for Updating Information in Registration Files for Technical Grade Active Ingredient (ingrediente activo grado técnico) and Formulated Pesticides (plaguicidas formulados), was rejected on the merits. In said judgment, Judges Cruz Castro and Rueda Leal saved the vote and ordered the action to proceed, because we believed the matter deserved to be elucidated through the unconstitutionality action procedure.

V.- SEPARATE NOTE FROM JUDGE HERNÁNDEZ LÓPEZ. I concur with the majority vote in this amparo appeal; however, I must expressly state that my position was to have the action filed at the time by the interested parties proceed regarding this matter.- My reasons were the following:

'From my perspective, the decree establishes procedures to bring a group of pesticide (plaguicidas) registrations up to date with current technical requirements and assures those who manage to meet such conditions not only a new authorization term (Article 6), but also the guarantee (Article 7) that state authorities will not hinder their business except when they can demonstrate "an unacceptable risk to human health, the environment, or agriculture." Read in this way (as proposed by the plaintiff), the norm seeks to provide the owners of the registrations with a guarantee against State actions regarding their products, but at the cost—according to the appellant—of sacrificing the precautionary principle that holds constitutional rank.- I believe that the Costa Rican legal system constitutionally and conventionally obligates the State to protect public health, in such a way that if a person reasonably proves a certain, real, and imminent risk to public health from the effects of a registered pesticide (plaguicida), the state authorities have the duty to act, regardless of whether that product is registered or not, because that registration could not be placed above a legal interest such as public health.' History has documented well-known examples of pesticides such as Nemagon or DDT which, despite having passed the tests and filters that existed at the time to guarantee their viability, turned out not to be innocuous for human health.

The challenged norm is inserted within a normative framework of protection at a constitutional and conventional level that obligates the authorities—even ex officio—to issue the precautionary measures they deem necessary when an injury (certain, real, and imminent to the health of the inhabitants) is reasonably established, in such a way that the phrase “unacceptable risk” is not one that the administration must conclusively prove, or that imposes the burden of proof on the administered party, but rather one that—as indicated supra—is reasonably accredited from the concrete facts, a protection for which the legal system provides, among other legal instruments, protection through the recurso de amparo.

Similarly, with regard to the precautionary principle (principio precautorio) in environmental matters, this Constitutional Court has taken important steps, as can be seen, for example, in the doctrine that can be extracted from judgment No. 2004-1923 of 2:55 p.m. on February 25, 2004, where the postulate that absolute scientific certainty should not be used as a reason to postpone the adoption of effective measures based on costs to prevent the degradation of the environment is extensively developed (…)

The transcribed judgment is binding for state authorities in such a way that both the right to health and the precautionary principle in environmental matters obligate the State to act even in the face of mere risk, provided, of course, that it is certain, real, and imminent, with which the norm under discussion could not undermine—and from my perspective it does not—the State's obligation to act to protect these legal interests, an action that is supported by constitutional and conventional norms. In that sense, I do not believe that the norm has, in itself, a wording that clashes with the indicated values, but if its application were to occur in a framework that threatens the indicated interests, the legal system has—over and above said norm of merely regulatory value—the immediate precautionary remedies that the administered party can request in protection of the same, among them, that of the recurso de amparo.

Consequently, for the reasons stated, I consider that the norm, in its content, can never per se undermine the constitutional and conventional obligation that the State has in the protection of health and the environment” I hereby clarify my position in that case and the reasons why I now concur with the majority.

Likewise, the Chamber referred to the constitutionality of decree No. 40059-MAG-MINAE-S, "RTCR 484:2016. Agricultural Inputs, Formulated Synthetic Pesticides, Technical Grade Active Ingredient, Adjuvants and Related Substances for Agricultural Use. Registration, Use and Control," whose purpose was to regulate the registration process for formulated synthetic pesticides, technical grade active ingredient, adjuvants, and related substances for agricultural use of the SFE. Its scope of application consists of natural or legal persons who register, market, import, formulate, manufacture, repackage, rewrap, store, distribute, and handle formulated chemical pesticides, technical grade active ingredient, adjuvants, related substances, as well as those of mineral origin and inorganic salts. Through vote No. 2022-023238, the majority dismissed the acción de inconstitucionalidad. From the foregoing, it can be seen that said regulation was the one applicable for novel registration processes.

On the other hand, in vote No. 2022-026651, this court referred to the constitutionality of decree No. 39995-MAG, called "Regulation for Updating the Information of the Registration Files for Technical Grade Active Ingredient and Formulated Pesticides" and, by majority, the acción de inconstitucionalidad was declared without merit. Said decree and the one being examined in the case file do not specifically refer to a registration or listing process for new pesticides, but rather their regulation is applicable for products already on the market, but whose registration was carried out under other parameters that did not require prior registration of the IAGT, for which reason the Executive Branch deemed it essential to update the information of these registrations and also establish a validity period equal to that of the registrations granted under the current regulations. Precisely in that constitutionality process, it was explained that decree No. 39995-MAG of December 15, 2016 is a regulation designed for updating the information of the registration files for technical grade active ingredient (IAGT) and formulated pesticides. The regulation seeks to comply with the registration of all chemical, biological, or related substances for agricultural use, of longstanding use in the SFE registry. This includes all those chemical entities not registered because the legislation did not establish it as a mandatory requirement. In this way, as of this Regulation, no IAGT and/or formulated product marketed in Costa Rica should be unknown to the State, and, even better, said regulation seeks to have the updated information that allows for better control. With this, it brings the technical and scientific information of old registrations up to date by associating the IAGTs with those registered under the regulations through which they were originally listed. In this way, it opens the possibility for the State to have the confidential chemical information that is lacking in the files of the old registrations. Based on such premises, the grievances of constitutionality formulated in the specific case will be examined next.

VI.- REGARDING LEGAL COMPETENCIES Firstly, the claimant affirms that the Ministry of Health and MINAE must actively participate in this process of registration, post-registration, and revalidation or updating of pesticide information, since the substances have a direct or indirect impact on the environment in general and consequently on people's health. He questions, therefore, that the decree grants the authority for only the SFE to grant registration unilaterally, without the participation of the other ministries, which in his judgment implies a regression in the level of protection and a violation of the principle of objectification of environmental protection (principio de objetivación de la tutela ambiental).

The Minister of Agriculture and Livestock explained, in this regard, that the legal and technical norms relating to phytosanitary protection (protección fitosanitaria) must be interpreted in accordance with the constitutional duty of the State and society in general to act in prevention of environmental risk and human and animal health, as is indeed done when issuing both executive decree No. 39995-MAG and No. 41481-MAG. He indicated that the legislator conferred on the SFE the competence to achieve the purposes contained in the Ley de Protección Fitosanitaria and that said assignment of competences is exclusive to said body, within which falls the creation and custody of the respective registries. To this effect, the provisions of the Ley de Sanidad Vegetal and the Ley de Protección Fitosanitaria are cited. The latter expressly establishes the competence in matters of registration and control of agricultural-use pesticides in the SFE.

On this matter, the PGR stated that the challenged decree does not include the participation of the Ministry of Health and MINAE, and, therefore, carries the same defect as decree 39995, unless the Chamber considers that the competences attributed to other bodies in their respective enabling laws are not repealed or modified by the challenged norm, and that the SFE – within the exercise of its legal competences – can and must require the participation of any specialized technical body to verify that a pesticide does not threaten health and the environment.

In this regard, the Chamber does not observe that it specifically constitutes an injury to the Right of the Constitution. The fact that the ordinary legislator has decided to concentrate the competences of phytosanitary protection in a specific legally-created authority such as the SFE, attached to the MAG, does not in any way imply an injury to any provision of our Political Constitution. It corresponds to a decision of specific organic and competence design that is of free configuration by the legislator and that, moreover, does not render null the stewardship (rectoría) that the Ministry of Health or MINAE may have in the matters proper to their competence. In this regard, the legislator provided broad competences in favor of the SFE precisely regarding phytosanitary protection. To this effect, Art. 5 of the Ley de Protección Fitosanitaria, No. 7664 establishes the following:

"ARTICLE 5.- Functions and obligations The Servicio Fitosanitario del Estado shall have the following functions: a) Ensure the sanitary protection (protección sanitaria) of plants. b) Advise on matters of phytosanitary protection and recommend the issuance of the necessary legal norms in this field. c) Coordinate with other ministries and their dependencies, the pertinent actions for compliance with this Law and its Regulations. It shall be a coadjuvant and auxiliary body of the Dirección General de Aduanas of the Ministry of Finance, in the control and oversight of the entry and values of agricultural merchandise or products. (Thus amended by Article 3 of Law No. 8373 of August 18, 2004). d) Prepare, recommend, coordinate, execute, and disseminate the regulations and provisions that guarantee the application of this law. e) Provide for and execute the technical, legal, and administrative measures to avoid, prevent, and delay the introduction or establishment of new pests in plants. f) Eradicate, control, or slow the spread of already-introduced pests. g) Carry out phytosanitary control of the national and international exchange of plants, biological control agents and other types of organisms used in agriculture, packaging and conditioning materials, and means of transport capable of spreading or introducing pests that threaten food security and the economic activity on which agricultural production is based. h) Formulate, execute, and supervise pest recognition and detection programs, as well as emergency plans. i) Study and diagnose the phytosanitary status of the country. j) Establish and keep updated a national information system regarding phytosanitary status. k) Officially declare the presence of pests and their quarantine importance. l) Evaluate and regulate, in the area of phytoprotection (fitoprotección), any production method. m) Organize, endorse or not endorse, and support the preparation, dissemination, and application of programs for the prevention and combat of existing pests. n) Promote and control integrated pest management and the appropriate methodologies used. ñ) Control the phytosanitary quality of propagation material. o) Control chemical, biological, or related substances for agricultural use, in terms of their registration, import, export, quality, tolerances, residues, dosages, effectiveness, toxicity, public presentation, conservation, handling, trade, general conditions of use, safety and precautions in transport, storage, elimination of containers and residues of such substances; likewise, control the equipment necessary to apply them and any other activity inherent to this matter. p) Control the phytosanitary quality of export plants to issue phytosanitary certificates, in accordance with current international treaties on the matter, this law and its regulations. q) Regulate, in the area of phytoprotection, the import, export, research, experimentation, movement, multiplication, industrial production, marketing, and use of transgenic materials and other genetically modified organisms for agricultural use or their products. r) Promote, support, and endorse the required phytosanitary scientific research. s) Manage technical and financial support from national and international organizations to strengthen the Servicio Fitosanitario del Estado. t) Recommend, to the Executive Branch, the ad honorem appointment of phytosanitary authorities. u) Ensure the administration, control, and use of the resources obtained by applying this law. v) Provide, by prior agreement, training, advice, and consultancies in matters of phytosanitary protection. x) Promote the international harmonization of phytosanitary measures. The controls mentioned in this article may be carried out in full or randomly, as established through technical criteria." (The highlighted text does not correspond to the original).

From the foregoing, it follows that the competence to "control chemical, biological, or related substances for agricultural use, in terms of their registration" was expressly assigned by the legislator to the SFE, without prejudice—as provided in the same article—to coordinating, with other ministries and their dependencies, the pertinent actions for compliance with this law and its regulations.

Furthermore, the law expressly establishes that the substances must be registered in the registry that the SFE is precisely responsible for creating and keeping, and also provides the consequences for not conforming to the procedure:

"Art. 23. Registration of substances and equipment. According to the requirements to be specified in the regulations of this law, all chemical, biological, or related substances and application equipment for agricultural use must be registered in the registry that the Servicio Fitosanitario del Estado shall create to have information on the characteristics of these and to ensure their correct use in the country.

Art. 24.- Registration of substances No natural or legal person may import, export, manufacture, formulate, store, distribute, transport, repack, rewrap, advertise, handle, mix, sell, or use chemical, biological, or related substances for agricultural use that are not registered in accordance with this law. (…)" It is required, of course, that these competences be fulfilled within the framework of the constitutional rights to health and a healthy environment, and that the SFE authorities must in all cases safeguard such rights.

In this regard, it is necessary to emphasize that this Court, in judgment No. 2022-023238, already established that, even though the registries are under the competence of the SFE, the other ministries mentioned have the possibility of warning, within the area of their competences, about the existence of prohibited materials or those subject to new restrictions in accordance with international regulations falling under such competences. It was warned that this type of regulation does not imply that the other functions of the two ministries are diminished and that they cannot exercise active participation and collaboration, prior to the granting of the registration or in the surveillance function, when a registration fails to comply with international obligations due to the use of internationally prohibited products; for example, international standards of unacceptable risks to health and the environment (see judgment No. 2022-023238). Indeed, in the report rendered in file No. 18-009107-0007-CO, the PGR stated the following:

"[T]he possible flexibilization of the pesticide registration procedure made by decree No. 40059-MAG-MINAE-S in pursuit of giving the agricultural sector greater access to lower-cost products or inputs, cannot be to the detriment of the legal competence of the technical bodies of the MAG, MINAE, and the MINSA to require the information they deem pertinent and determine, through rigorous evaluations and data analyses, that the requested agrochemicals are innocuous for the health of people and the environment." (The highlighted text does not correspond to the original).

Moreover, it must be observed that the criticisms made by the claimant—in light of the CGR's considerations—had a different normative context, for it was precisely in response to said recommendations and omissions that a transitional measure was expressly adopted in executive decree No. 40059 "Technical Regulation: 'RTCR 484:2016. Agricultural Inputs. Formulated Synthetic Pesticides, Technical Grade Active Ingredient Adjuvants and Related Substances for Agricultural Use.' Registration, Use and Control,” in force as of July 13, 2017, which precisely tends to provide the MAG and the SFE with suitable technical bodies to resolve everything related to agrochemical registrations and expressly establishes that said body must operate “without prejudice to the constitutional or legal powers corresponding to the Ministries of Health or Environment”:

“**FIFTH TRANSITIONAL PROVISION:** The Ministry of Agriculture and Livestock shall establish within its structure, within a period of twelve months from the entry into force of this decree, the Evaluation Areas: chemical, agronomic, toxicological, and ecotoxicological, as part of the Registration Unit for Agrochemicals and Application Equipment, and which shall be responsible for the review, verification of compliance with requirements, evaluation, and qualification of the toxicological and ecotoxicological documents and studies and environmental fate, established by this regulation in the different registration modalities, without prejudice to the constitutional or legal powers corresponding to the Ministries of Health or Environment.” (Emphasis not in the original).

Consequently, it is the responsibility of the national technical authorities, in accordance with the broad powers granted by the legal system, to carry out the procedure for updating the information in the registration dossiers for technical grade active ingredient and formulated pesticides with extreme rigor and care in order to protect the fundamental rights to health and a healthy environment of all inhabitants. Thus, the ultimate responsibility for the decision on whether or not to authorize the update request for the products lies with the national authorities. In this regard, in judgment No. 2022-023238, it was concluded that in each specific petition—in the specific case, it refers to updating the information in the registration dossiers for technical grade active ingredient and formulated pesticides—, it is the responsibility of our national authorities to be vigilant with respect to the studies submitted for assessment, and it does not imply, in any way, an authorization for them to relax in the process and vigilance that must be carried out.

On this point, it must be added that, even if we had the highest regulatory standards, that alone would not be sufficient if the national authorities do not responsibly exercise the powers that concern them. In this sense, a dismissal of the grievance does not mean that it is endorsing that the authorities not be vigilant a priori and a posteriori. On the contrary, this Chamber understands that, even at the slightest trace of doubt, they must proceed to request all pertinent documentation or studies, with the purpose of verifying that the product for which the registration is to be updated complies with the necessary parameters and conditions to safeguard human health. Likewise, it is their responsibility to ensure that its use is appropriate and has the desired effects. Rigor in the selection of studies is as important as the subsequent controls that can be carried out in the application and use of the products.

It is opportune to cite the reflections made by this Chamber in judgment No. 2011-016937, regarding its knowledge of other regulations aimed at the registration of pesticides:

“**VII.- ON THE REDUCTION OF RISKS TO HEALTH AND THE ENVIRONMENT, IN ACCORDANCE WITH THE PROVISIONS OF ARTICLE 5 OF THE INTERNATIONAL CODE OF CONDUCT ON THE DISTRIBUTION AND USE OF PESTICIDES.** It is of interest to refer to the provisions of the cited International Code of Conduct on the Distribution and Use of Pesticides, which was adopted, for the first time in 1985, by the twenty-fifth session of the conference of the Food and Agriculture Organization of the United Nations (FAO). As explained in the preface of the revised version (adopted by the 123rd session of the FAO Council, November 2002), said code of conduct was adopted and has been revised with the purpose of achieving greater food security and, at the same time, protecting human health and the environment. For these purposes, standards of conduct are established that must serve as a framework and point of reference for the adequate and rational use of pesticides, focusing on risk reduction, the protection of human and environmental health, and support for the development of sustainable agriculture through the effective use of pesticides [source: (Source: http://www.fao.org/agriculture/crops/core-themes/theme/pests/pm/code/en/(05/08/11)] (…)

**VIII.- ON THE REGULATION REGARDING THE REGISTRATION OF PESTICIDES.** The appropriate use of pesticides can be useful for the control and elimination of pests, in benefit of the food security of the population and the economic activity sustained by agricultural production. However, the potential risk that the use of such substances may imply for human health and the environment must be recognized. This has even motivated the adoption of international instruments with the express objective of protecting human health—including the health of consumers and workers—and the environment from the possible harmful effects of pesticides, as is the case of the Rotterdam Convention on the Prior Informed Consent Procedure for Certain Hazardous Chemicals and Pesticides in International Trade, which was approved by Costa Rica, through Law No. 8705 of February 13, 2009. In which case, before the mandatory legislative consultation of constitutionality filed before this Court (file number 08-015252-0007-CO), prior to the approval of said international instrument, this Court indicated—in what is relevant—that:

“(…) **the Costa Rican State has the duty to act effectively and proactively, to avoid the occurrence of events that degrade the environment and compromise its sustainability**. From that perspective, committing itself, through an international treaty such as the one consulted, or through an internal act, to facilitate the rational use of chemically dangerous products subject to international trade, is not only possible but totally in accordance with its constitutional duties. Pesticides and industrial chemical products are substances that can cause damage to human health and the environment. Faced with such a threat, the Rotterdam Convention provides the Parties with the possibility of knowing in advance the composition and effects of certain chemical products, which are expressly indicated in its Annex III. The suitable measures that the State takes to regulate the commercialization and use of said products in industrial, agricultural activities, etc., are in accordance with its duty to preserve the aforementioned values of constitutional rank. Hence, the duties that the State would assume in case of definitely approving this Convention are legitimate, in accordance with Constitutional Law. It would be a sovereign decision of the State to submit to the obligations contained in the Convention, to contribute to the protection of people's health and the integrity of the environment, for which it can be concluded that, in general terms, no defects of unconstitutionality are observed in the clauses of the Rotterdam Convention, the approval of which is submitted for consultation.” (resolution number 2008-018207 of 6:15 p.m. on December 10, 2008) With which it is verified that this Court has recognized the risk that the use of pesticides may entail and the importance of adopting suitable measures to regulate their use. **In the Costa Rican legal system, there is diverse legal and regulatory legislation from which it is derived that the activity of import, manufacture, commercialization, and use of pesticides is strongly subjected to the police power of the State, in order to guarantee the right to health and to a healthy and ecologically balanced environment**. One can cite, first, the General Health Law, which in its article 213 provides:

“ARTICLE 213.- Any person, natural or juridical, who engages in producing food, must do so under sanitary environmental conditions and using defense or conservation techniques approved by the health authority, in order to avoid, mainly, the contamination of such products and their dangerousness due to the presence of toxic residues from their treatment with pesticides or other defense or conservation systems.” While article 244 of that same normative body establishes:

“ARTICLE 244.- Natural and juridical persons who import, manufacture, handle, store, transport, trade, supply, or apply substances, mixtures of substances, or products called pesticides by the plant health law, shall be subject to the regulatory provisions that the Ministry dictates in common agreement with the Ministry of Agriculture for the safeguarding of people's health in accordance with that law, interested parties must register every pesticide or product destined for the control or extermination of infestations and request prior permission to operate when such substances, mixtures of substances, or products that by their nature or use are not included in the aforementioned law are capable in some way of producing intoxications or serious damage to the health of people or of useful or harmless animals to humans.” **In turn, through the Plant Protection Law (Law No. 7664 of April 8, 1997), the phytosanitary protection measures established in that law and its regulations were declared of public interest and mandatory application (art. 1). Furthermore, within the objectives of said law is included: "Regulate the use and management of chemical, biological, or related substances and equipment to apply them in agriculture; likewise, their registration, import, quality, and residues, while seeking at the same time to protect human health and the environment**" (article 2, subsection e). The competent authority in the matter is the State Phytosanitary Service, which is responsible—among other functions—for: "Controlling chemical, biological, or related substances for agricultural use, regarding their registration, import, export, quality, tolerance, residues, dosages, effectiveness, toxicity, presentation to the public, conservation, management, trade, general conditions of use, safety, and precautions in the transport, storage, elimination of containers and residues of such substances; likewise, controlling the equipment necessary to apply them and any other activity inherent to this matter" (article 5, subsection o). (…) It is deduced from the previously cited regulations that, as a manifestation of the referred police power, the necessary registration of pesticides is included prior to authorizing their import, manufacture, commercialization, or use, in order to be able to exercise prior control regarding the due compliance with the corresponding technical requirements of quality and safety, in protection of public health and the environment.” These considerations are applicable in the sub lite case, that is, that the domestic legal system contemplates various regulations and powers in favor of the national technical authorities so that, in use of that police power, they remain vigilant and guarantee the quality and benefit of the pesticide products whose registrations are intended to be updated and, ultimately, that the rights of all persons are thus safeguarded.

In this regard, as will be seen infra in detail, the challenged regulations are not designed for the registration of new pesticide products, but to update the registrations of products that are already registered and freely commercialized in the domestic market. In the event of the slightest doubt that the duly registered pesticide (whether as TGAI or formulated pesticide) causes harm or a threat to health or the environment, all national authorities, including the Ministry of Health or MINAE, have their own attributions and powers to institute the corresponding procedures to prevent the import, manufacture, handling, commercialization, or use of the product. Moreover, if necessary, they can dictate the precautionary measures that are needed to safeguard the legal interests mentioned. Precisely, the precautionary principle—which is invoked by the claimant—must inspire all a priori and a posteriori control conduct of all the public authorities mentioned, and if, in any specific case, there is suspicion or evidence of damage or threats to public health or the environment, they are under the constitutional obligation to adopt the corresponding preventive measures.

Echo must be made of what was already indicated in judgment No. 2017-06668, regarding the constitutionality of Executive Decree No. 39995-MAG, and which is also applicable to this decree, since the fact that the Ministers of Health and Environment and Energy have not signed the decree does not imply a defect of unconstitutionality of the questioned regulations because it has been issued, jointly, by the President of the Republic and the Minister of Agriculture, with which, no affectation of the provisions of art. 146 of the Political Constitution is observed.

Finally, it is reiterated that, in light of the provisions of art. 10 of the General Law of Public Administration (LGAP)—the administrative rule must be interpreted in the manner that best guarantees the realization of the public purpose to which it is directed—, this special regulation must be applied and interpreted integrally with the provisions of the legal system on the matter (public interest laws mentioned supra). That is to say, in no way can it be understood that the challenged provisions constitute an isolated normative body from the rest of the block of legality and constitutionality, and that the specific task of updating registration information implies annulling the rest of the legal powers entrusted to other ministerial portfolios.

By virtue of the foregoing, based on the considerations made, this Chamber cannot prove the alleged injuries to the precautionary principle attributed to the decree, solely because it is signed by the MAG and because the registration update powers are concentrated in the SFE. As examined, such powers are imperium powers granted by the legislator itself (art. 59 LGAP) which does not nullify the other legal provisions of public interest in the matter.

**VII.- ON THE PROCEDURE REGULATED BY THE CHALLENGED REGULATIONS** The claimant insists that the Ministry of Health and MINAE must intervene in these processes, even more so when in this case it is not a simple update, but a scientific analysis of the information presented by the registrant to carry out the respective risk assessment.

On this point, the Minister of Agriculture and Livestock explains that the decree for updating dossiers and its reform applies exclusively to all registrations of “technical grade active ingredient” (TGAI) and formulated products that were registered under a regulation (legal or regulatory) different from Executive Decree No. 33495-MAG-S-MEIC-MINAET, “Reglamento sobre Registro, Uso y Control de Plaguicidas Sintéticos Formulados, Ingrediente Activo Grado Técnico, Coadyuvantes y Sustancias Afines de Uso Agrícola”. That is, he emphasizes that it only applies to those registration dossiers for products that are already on the market and that were registered in accordance with the regulations applicable at the time of their approval and that were comprehensively evaluated (health, environment, and biological efficacy) in accordance with those regulations. He argues that the claimant confuses and intends to confuse regarding the registered agrochemicals that are currently commercialized in the country, which are the ones to which Executive Decrees No. 39995-MAG and No. 41481-MAG apply, attempting to make people believe that they must be re-evaluated, which is neither appropriate nor necessary, since all products registered in Costa Rica complied with the requirements and regulations established in the positive law in force at the time those registrations were granted. Consequently, he vehemently clarifies that for none of the pesticide products, whether raw materials or formulated products that have a current registration, is there evidence or scientific technical presumption, or at least indications, that presume an additional or resulting danger from its application, regarding human health, the environment, or the biological efficacy of the pesticide. Both this Constitutional Chamber and the PGR have been clear in the sense that both the Ministry of Health, the Ministry of Environment, the Ministry of Agriculture, or even private individuals, can go to the ordinary jurisdictional venue to request the annulment of the administrative acts through which those registrations were granted, and they can even request that their commercialization be suspended as a precautionary measure. However, neither the Ministry of Health, nor the Ministry of Environment, nor the claimant does so because they lack evidence, scientific and technical support to do so, and therefore, he understands that the claimant recklessly comes to this Constitutional Chamber to raise legality issues through actions of unconstitutionality, whose sole purpose and objective is to hinder the process of organizing the agrochemical registration system undertaken by the Administration.

He insists that with the mentioned decrees—No. 39995-MAG and No. 41481-MAG—registrations for new TGAI or new formulated pesticides are not being granted, but rather they only apply to old TGAI (raw materials) and formulated products. In this regard, he explains that it was from 2007 onwards that a registration system was established that requires the prior registration of the raw material—TGAI. Before that date, it was not necessary to register the TGAI, and that is why the Executive Branch issued the decrees under challenge. He alleges that it is not as the claimant indicates, that through the challenged regulations the registration of new products is being facilitated, since the truth is that nothing is facilitated, but rather a space is opened for the registration holders to submit confidential chemical information, which is fundamental to guarantee that there are no relevant impurities from a toxicological and ecotoxicological point of view in any of the products currently commercialized in the market by virtue of a current registration, granted for an indefinite period.

Therefore, it argues that it is not correct to assert that the application of these rules means that the records updated in their files pose an additional risk to health, the environment, or agriculture, since all IAGT registrations that are granted must, necessarily and inevitably, correspond to one of the formulations already sold on the market, and over these formulations the Ministries of Health or Environment have broad and indisputable powers and faculties to adopt the pertinent measures to prevent damage to health or the environment.

It points out that Executive Decree No. 39995-MAG and its amendment No. 41481-MAG allow for the resolution of problems of disorder, uncertainty, and lack of information in the registration files covering the inscriptions of IAGTs and formulated pesticides with valid registration, but which were granted under regulations different from Executive Decree No. 33495-MAG-S-MINAE-MEIC. It considers that the questioned regulations represent a great advance and resolve a problem that began in 2004 and had still not been resolved by previous administrations, as it provides for alternatives and pathways to resolve the two most serious problems afflicting our country's registration system: on the one hand, the paralysis in the registration of new and generic products, and, on the other, the impossibility of renewing the registrations of formulations currently on the market.

In that sense, it details that the challenged regulations allow: a) the updating of manufacturers, their origin, and production sites of the IAGTs associated with formulations already marketed in Costa Rica and that were registered under different legislation; b) the same in relation to formulated pesticides; c) an end to legal uncertainty regarding the validity of IAGT registrations and formulated pesticides that were registered under previous legislation and regulations, standardizing the validity period to ten years for all registrations and thus eliminating the indefinite validity period. It explains, consequently, that all the chemical information required to make decisions regarding the product concerning its safety and efficacy is gathered into the registration file required by Article 23 of the Phytosanitary Protection Law, and puts an end to indefinite-term registrations.

While the amparo action (recurso de amparo) **No. 17-002503-0007-CO** was being processed, the then Minister of MAG reported under oath to this Chamber as follows:

*"regarding the grounds giving rise to the promulgation of Executive Decree No. 39995-MAG, they are found in the 7 recitals (considerandos), of which the first 6 provide the legal basis, in this case the Phytosanitary Protection Law No. 7664, whose purpose is to regulate the use and handling of chemical, biological, or related substances and equipment for applying them in agriculture; likewise, their registration, importation, quality, and residues, while simultaneously seeking to protect human health and the environment, all of which must be registered in the registry that the State Phytosanitary Service will create to have information available on their characteristics and to ensure their correct use in the country. Pesticides for agricultural use are essential for combating pests that affect agricultural production and for the competitiveness of agricultural producers; therefore, it is essential to guarantee the supply and continuity of the marketing of products that currently hold valid registration, making it necessary to update the information in their files on their characteristics and ensure their correct use in the country. It is precisely this recital (considerando) that summarizes the purpose of the decree under analysis. **The decree indicates in its recital 4 that regulations prior to the entry into force of Executive Decree No. 33495 MAG-S-MENAE-ME1C of October 31, 2006, and its amendments, allowed the Ministry of Agriculture and Livestock to grant indefinite-term registrations, as well as the inscription of formulated pesticides without the requirement of prior registration of the technical grade active ingredient (IAGT), which obliges, within the constitutional and legal powers of the Executive Branch, the organization of its registry, ordering the updating of information of registrations inscribed without a term as they were granted under regulations prior to those governing the current registration. The appealed decree seeks to update the files with information that was not requested at the time of their registration and to have updated information, through a re-registration process in accordance with Article 50 of the Constitution, such that the State shall procure the greatest well-being for all the inhabitants of the country, organizing and stimulating production and the most adequate distribution of wealth, guaranteeing a healthy and ecologically balanced environment**. The State will guarantee, defend, and preserve that right, which is guaranteed by the decree since, although production is stimulated, this does not prevent the protection of the environment, health, and life, none of which can be put at risk, reason for which the Ministry of Agriculture and Livestock has the legal authority to administer the registry assigned to it by law and for which it must at a minimum update the files as part of its internal organization. The registrations granted prior to Executive Decree No. 33495-MAGS-MINAE-MEIC of October 31, 2006, and its amendments, were granted without a term, which obliges the Executive Branch to analyze those registrations, requesting from each registrant the information established in the Decree at hand to update the registration and, therefore, the information, so that registrants can register in accordance with the requirements of current regulations, while simultaneously guaranteeing the continuity of their marketing, given their importance as a tool for combating agricultural pests and also stimulating the production entrusted by law to the Ministry of Agriculture and Livestock, without detriment to other constitutional guarantees such as life and a healthy environment, so long as production is not harmed, insofar as it does not affect life. Due to the nature of the issued regulation, this is not a technical regulation (Reglamento técnico) but rather an update of valid registrations, so the technical regulation procedure is not required; nonetheless, the regulation was uploaded to the MEIC website, as evidenced in the attached administrative file, completing the Cost-Benefit Evaluation Form in Section 1, called Prior Control for Regulatory Improvement, which yielded a negative result and was available to citizens on a freely accessible website. The decree, in summary, orders that the holders of registrations of Technical Grade Active Ingredients (IAGT) and formulated products that do not have an IAGT registration, and which were not inscribed in accordance with Executive Decree No. 33495-MAG-S-MINAE-MEIC of October 31, 2006, and its amendments, must update the manufacturer(s) of their IAGTs, within a period of twenty-four months from the entry into force of this decree; providing the State Phytosanitary Service the information indicated therein for the manufacturer update, also referring to the provisions of the Central American Technical Regulation No. RTCA 65.05.67.13: Agricultural Inputs. Technical Grade Active Ingredient, Formulated Chemical Pesticides, Related Substances, Adjuvants, and Physical Vehicles for Agricultural Use. Requirements for the preparation of labels and leaflets. Resolution No. 365-2015 (COMIECO LXXII). In the case of formulated pesticides whose IAGT is not registered, and whose file has been updated, the State Phytosanitary Service will grant, within a period of no more than three months from the date on which the update was approved, the corresponding IAGT registration. The decree expressly establishes that the IAGT registrations granted in accordance with the decree may not be used as a reference profile under the equivalence registration modality, unless the complete data package has been provided. Article 7 refers to the legal powers that different laws grant to the Ministry of Health and the Ministry of Environment, but not to the administration of the registry, which is what the regulation aims at, since the power of the Ministries of Health, Environment, and Agriculture to restrict or prohibit a use of a pesticide is independent of the referenced decree. Based on the report provided, the administrative file, and the text of the challenged decree, it is understood that the Decree pursues the internal organization of the Registration Office of the SFE, as a minimum deconcentration body of the Ministry of Agriculture and Livestock. It requests that this amparo action (recurso de amparo) be declared without merit in all its aspects.".* In this regard, **the Chamber** considers it necessary to clarify the scope of the regulations challenged in action No. 18-019039-0007-CO (relating to Executive Decree No. 39995-MAG) and the one under review in this action (relating to Executive Decree No. 41481-MAG).

To this end, it is appropriate to cite the recitals or preamble of both decrees, as they offer significant insight into the objectives of the rules in question. The "Regulation for the updating of information in the registration files of technical grade active ingredient and formulated pesticides, No. 39995-MAG", starts from the following premises:

*"1°-That one of the objectives of the Phytosanitary Protection Law is to regulate the use and handling of chemical, biological, or related substances and equipment for applying them in agriculture; likewise, their registration, importation, quality, and residues, while simultaneously seeking to protect human health and the environment.* *2°-That the Phytosanitary Protection Law expressly establishes that all chemical, biological, or related substances and application equipment for agricultural use must be registered in the registry that the State Phytosanitary Service will create to have information available on their characteristics and to ensure their correct use in the country.* *3°-That pesticides for agricultural use are essential for combating pests that affect agricultural production and for the competitiveness of agricultural producers; therefore, it is essential to guarantee the supply and continuity of the marketing of products that currently hold valid registration, making it necessary to update the information in their files on their characteristics and ensure their correct use in the country.* *4°-That regulations prior to the entry into force of Executive Decree No. 33495 MAG-S-MINAE-MEIC of October 31, 2006, and its amendments, allowed the Ministry of Agriculture and Livestock to grant indefinite-term registrations, as well as the inscription of formulated pesticides without the requirement of prior registration of the technical grade active ingredient (IAGT), making it necessary to update the information of these registrations and also establish a validity period equal to that of registrations granted under current regulations.* *5°-That international regulations establish toxicological, ecotoxicological, and environmental fate information requirements indicated in Executive Decree No. 33495-MAGS-MINAE-MEIC of October 31, 2006, and its amendments, which were not requested under previous regulations; therefore, it is necessary to extend the registrations granted before said Executive Decree, so that they may enter a registration process in accordance with the requirements of current regulations, while simultaneously guaranteeing the continuity of their marketing, given their importance as a tool for combating agricultural pests.* *6°-That both the Food and Agriculture Organization of the United Nations (FAO) and the World Health Organization (WHO) recognize that the repetitive generation of studies and information regarding all potential/actual risks for each manufacturer of a pesticide can be unnecessary and ethically undesirable.* *7°-That the Cost-Benefit Evaluation Form was completed in Section 1, called Prior Control for Regulatory Improvement, which yielded a negative result, and that the proposal has no procedures or requirements."* While the premises of the "Amendment to the Regulation for the updating of information in the registration files of technical grade active ingredient and formulated pesticides", No. 41481 – MAG, are as follows:

*"WHEREAS (CONSIDERANDO)* *1.- That by Executive Decree No. 39995-MAG of December 15, 2016, published in Gazette No. 11, Supplement No. of January 16, 2017, the Regulation for the updating of information in the registration files of technical grade active ingredient and formulated pesticides was enacted.* *2.- **That the State Phytosanitary Service, hereinafter (SFE), upon an inquiry from its Internal Audit to the Office of the Attorney General of the Republic, suspended the application of Decree 39995-MAG, and currently, due to lack of procedure, it has not been possible to update the information for any of the registrations of Technical Grade Active Ingredients, hereinafter (IAGT), and formulated products that do not have an IAGT registration and which were not inscribed in accordance with Executive Decree No. 33495-MAG-SMINAE-MEIC of October 31, 2006, and its amendments**.* *3.- That the Office of the Attorney General of the Republic, upon the inquiry from the Internal Audit of the SFE, issued Opinion No. C-199-2017 of September 8, 2017, concluding regarding Executive Decree 39995-MAG that: "it is a revalidation of prior registrations, inscribed under other regulations and does not refer to an inscription procedure per se. Furthermore, as established in recital 6°, it aims to set a validity period for these registrations that were previously indefinite". "Therefore, it cannot be inferred from said Decree that it is a technical regulation (reglamento técnico) requiring a consultation procedure with the Technical Regulation Body. On the contrary, it is the development of what is set forth in Article 23 of the Phytosanitary Protection Law.* *4.- That both national legislation and international regulations establish that the confidential information provided by registrants in registration and file updating processes, due to its protection regime and commercial sensitivity, must be diligently and appropriately safeguarded by the authorities to guarantee its inviolability and prevent improper use.* *5.- That the specifications and international standards of first-world countries and regions, as well as international organizations of recognized international prestige, are a technical and scientific reference to determine that the technical grade active ingredients synthesized by the manufacturers proposed in the file updating processes do not contain relevant impurities at levels exceeding the international standards or specifications, and relevant impurities are those that have toxicological or ecotoxicological relevance, which could cause an impact on health or the environment.* *6.- That technical grade active ingredients are used solely for the formulation of formulated synthetic chemical pesticides and are only exceptionally used directly in the field, and these exceptional situations are already regulated in the current technical regulations; therefore, the registration certificates for technical grade active ingredients are only useful for authorizing, by the State Phytosanitary Service, the importation of these as raw material for pesticide formulations in processing plants and not for their direct use in the field.* *7.- That Executive Decree 39995-MAG, repeatedly cited, established a period of twenty-four months for the updating of the Registration, which expires on January 16, 2019, and that currently there is no procedure to allow its application, making it opportune and convenient to establish a new reasonable period for the application of the decree in question and the procedures.* *8- That approval has been obtained from the Directorate of Regulatory Improvement of the Ministry of Economy, Industry and Commerce, according to Report DMR-DAR-INF-149-18, of December sixth, two thousand eighteen".* (The highlight is not in the original).

Thus, it is reiterated that the regulations under review apply only to old products, that is, products for which an IAGT or formulated pesticide registration has already been granted, and many of these registrations were granted for an indefinite term. This means they do not require the updating decree to continue being marketed. Therefore, more than facilitating, it is about imposing an obligation on them to update their information and provide data and studies that certify not only the provenance and origin of the technical materials and associated formulations, but also provide the confidential chemical information that allows the registration authority, the SFE, to have at its disposal confidential chemical information on purity, impurities, synthesis method, etc., of their technical materials, both regarding manufacturers and formulators. It is precisely from the detail of the information provided that the registration authority can make regulatory decisions regarding the continuity or not of a registration or of a manufacturer of a technical material for a formulation marketed in Costa Rica. As emphasized *supra*, if they do not submit to this registration update procedure, action may be taken in accordance with the provisions of Art. 24 of the Phytosanitary Protection Law. Likewise, with the complete registration information, decisions can be made in light of what is expressly regulated by Art. 30 of the same law:

*"Art. 30.- Prohibitions and restrictions for technical reasons* *The Ministry of Agriculture and Livestock may restrict or prohibit the importation, transit, re-routing, manufacturing, formulation, repackaging, repacking, storage, sale, mixture, and use of chemical, biological, or related substances and application equipment for agricultural use, when justified for technical reasons and it is considered that their use is harmful to agriculture, health, or the environment".* It can be appreciated that this police power empowers the State to evaluate products in light of updated information and adopt the corresponding decisions to safeguard agriculture, health, or the environment.

Now, the grievance of the petitioner, beyond specifying aspects of the concrete procedure, focuses on questioning that, in their opinion, the Ministry of Health and MINAE should intervene. However, as already examined *supra*, the fact that they did not participate in the adoption of the regulations, or in the registration information update process, in no way implies *per se* an injury to the Right of the Constitution.

Now, although not detailed by the petitioner in this section, it should be noted that the presentation of information from other registration files was endorsed by the majority of this Court in judgment **No. 2022-26651,** in light of the international technical legislation that permits it, for which reason, regarding these aspects, it is necessary to abide by what was stated in the referenced decision.

**VIII.- REGARDING ART.** 1st OF THE DECREE The **claimant** asserts that the partial amendment and addition to Executive Decree No. 39995 is a benefit to pesticide marketers, because they extend the time starting from the publication of the challenged decree, granting the benefit of five more years to those products without them having undergone a risk assessment and granting that additional time for the registration holders to submit the information. Even though this same article defines an exhaustive list of requirements, he considers them limited for conducting a risk assessment. He assumes that what the ministerial office seeks with the enactment of this type of document is to demand, order, or intimidate the registration evaluators into limiting themselves solely to requesting limited information lacking the technical and scientific support to conduct a risk assessment according to national and international standards, with decimated requirements. He questions that in the article in question, the MAG again insists on the referenced information process, without own or referenced information as this regulation proposes. Thus, the Executive Branch and the pesticide industry are seeking to facilitate the trade of pesticides to the detriment of human health, animal health, and the environment.

In this regard, the **Minister of MAG** explains that the challenged article maintains its scope of application in the sense that it cannot be used to register new pesticides and the only thing that changes is related to the deadlines and one of the administrative requirements. Regarding the deadlines, he considers it a matter of legality, since it is the competent authority's responsibility to define the deadlines for performing certain acts and the deadlines the administered party must meet for its procedures under the rule. Furthermore, it is insisted that the powers were delegated by the will of the legislator to the MAG through the SFE. From a technical and scientific point of view, the regulation allows the State to have all the information on purity, relevant impurities (name, content and detection levels), total impurities, synthesis method, analytical methodologies to determine the TGAI and its relevant impurities, for all TGAIs registered as such or as components of a formulation, which were registered in Costa Rica under legislation and regulations different from Executive Decree No. 33495-MAG-S-MEIC-MINAET. The confidential chemical information required by this decree is key and essential, from the agronomic, toxicological, and ecotoxicological point of view, and unfortunately, it is not incorporated into the files of these registrations. Much of the chemical information requested in the decree, especially that described in Articles 1 and 5, although it was indeed submitted during the revalidation process (reválida), is completely outdated, since between five and ten years have passed since the information was provided and the authorities have not yet reviewed it, much less approved it. Furthermore, it allows the Costa Rican State to have updated information on the formulation sites and origins, the name and physical location of formulators, as well as the components of the product and the detailed description of the formulation processes for all formulated products currently marketed in Costa Rica.

From a chemical and scientific point of view, this guarantees that no formulated pesticide marketed in Costa Rica can be registered, and therefore marketed, if it does not have an associated TGAI with levels of relevant impurities (those having toxicological and ecotoxicological importance) exceeding the levels specified in international reference standards (FAO, EPSA, IUPAC).

The **PGR** considers that it lacks the competence to refer to the technical aspects and suitability of the requirements demanded for updating the registrations. However, it does note that the Chamber must technically assess whether the requirements established by the challenged rule for the revalidation process (reválida) allow an adequate assessment of the environmental or health risk of the products, since from a mere comparison of the texts of Decree No. 39995 and Decree No. 41841, it is verified that the technical requirements contained in Decree No. 33495 were not added, but rather, some points were eliminated and modified. Additionally, it points out that the challenged decree modifies Articles 1.2.b and 6 of Decree No. 39995 that allow registering products through referenced information, but maintains that possibility in several provisions and does not establish how the information will be verifiable, how to determine which international specification can be used, the method for determining product equivalence, nor whether the reference profile to be used must be a registration with complete information. By not precisely establishing the rules to which the competent authority must adhere to verify the information, it is possible that the updating of registrations with referenced information that does not meet the indicated requirements will be allowed, and therefore, subject to what is provided in the technical criteria issued, this would imply the updating of product registrations without a prior assessment of the environmental and health risks of their application, and the unconstitutionality of the articles that allow the use of referenced information without an adequate equivalence determination.

In this regard, the **Chamber** considers, regarding the information reported by the PGR, it is appropriate to clarify the argument provided in light of the explanations given by the Minister of MAG. The PGR affirmed that from a mere comparison of the texts of Decree No. 39995 and Decree No. 41841, it is verified that the technical requirements contained in Decree No. 33495 were not added. However, as has been explained, these regulatory instruments govern different situations, which would justify the requirement of different sets of requirements. Decree No. 33495 regulated all the procedures for registering new products, while Decrees No. 39995 and No. 41841 regulate another, different de facto situation, because they apply to products that are already registered and in use in the national territory, but for which it is necessary to perform an update of their registrations. This would justify the differentiated treatment that the PGR questions.

Now then, attending to the grievances of the claimant, it must be stated that the extension of the deadline obeys a practical situation justified in the decree’s considerations. That is, the application of the prior decree was suspended by virtue of an administrative decision that paralyzed the procedure that was being carried out:

“That the State Phytosanitary Service (Servicio Fitosanitario del Estado), hereinafter (SFE), following a query from its Internal Audit to the Attorney General's Office (Procuraduría General de la República), suspended the application of Decree 39995-MAG **and currently, due to lack of procedure, it has not been possible to update the information for any of the registrations of Technical Grade Active Ingredients, hereinafter (TGAI), and formulated products that do not have a TGAI registration and that were not registered pursuant to Executive Decree N° 33495**-MAG-SMINAE-MEIC of October 31, 2006, and its amendments”. (The highlighting does not correspond to the original).

The foregoing justifies the claimed extension of the deadline.

Subsequently, the claimant's argument is reduced to stating that the requirements are limited and imply a way of intimidating the registrar so as not to request more information from the applicants. Said argument lacks an adequate and reasonable foundation, as it does not detail which requirements are considered insufficient. Moreover, regarding the application, it is nothing more than a mere subjective appreciation of an eventual consequence of the rule, which has no support in an objective element arising from the clause under analysis. Nor does the claimant's presumption that these rules seek to facilitate the work of traders have any support, all of which was rejected and justified in the MAG's report. Therefore, this Chamber deems that these grievances must be dismissed.

Regarding the referenced information, this Court, in judgment **No. 2022-26651**, as has been stated, conducted an analysis of the international technical legislation that allows for the submission of information from other registration files and concluded that the possibility of using referenced information from non-national authority registrations to process registration procedures is not unconstitutional, because it is justified in the international technical and scientific instruments that this judgment addresses. For this reason, regarding these aspects, it is necessary to abide by what was stated in the aforementioned ruling and dismiss the grievances.

**IX.- REGARDING ART. 2** The **claimant** alleges that the proposed amendment reduces the time for evaluators to make a decision, changing from three months defined in Executive Decree No. 39995 to one month in the amendment proposed in Decree No. 41481-MAG. He argues that this demonstrates what is sought in this type of regulation is the benefit of the companies selling agrochemicals, so that registration analysts conduct the analysis pressured by time, without a workload study to determine the proposed time. He adds that what is most serious is that the analysis proposed in this decree is defined as a simple verification of chemical documents, that is, whether the registrants submitted the information or not, but the degree of lack of coordination is such that this verification of documents, which are chemical in nature, is assigned to professionals in agronomy, who neither have the competence nor the training to perform this task. This proposed approach is a new registration modality that is only carried out with a simple "check list" or verification list.

The **Minister of MAG** maintains that, on this point, the claimant party merely objects to matters of mere legality and is remiss regarding the alleged unconstitutionalities of the rule it challenges. He points out that, even from a plain and simple reading of the text, it is evident that the claimant's assertion that registrations are being granted for new products through this regulatory standard is fallacious. He adds that it is also not true, as the claimant asserts, that agronomists are in charge of reviewing the chemical information; but beyond the inaccuracies and fallacies incurred by the claimant, it is clear that his arguments concern administrative aspects and mere legality matters that are not for the Constitutional Chamber to resolve, but for the ordinary jurisdiction.

The **PGR** considers that the unconstitutionality of Article 2 must be declared if, based on the technical criteria submitted to the file, it is determined that the reduction of the deadline from three months to one month, for the SFE to verify and analyze the submitted information and resolve the product update request and grant the registration certificate, prevents an adequate assessment of the environmental and health risk of the product. It adds that, without prejudice to what is decided regarding that article, it is convenient for the Constitutional Chamber to clarify whether the rule applies that the concept of positive silence (silencio positivo) does not operate in the case of environmental approvals or authorizations, and that, therefore, the Administration's failure to meet the established deadline would not imply the automatic approval of the product revalidation.

The current **rule**, compared with the original decree, establishes the following:

For the **Chamber**, the arguments of unconstitutionality lack adequate foundation. The mere fact that resolution deadlines are reduced does not mean that this procedure itself is less protective or harmful to constitutional provisions. It must be understood that, by virtue of the constitutional principles that must govern the functioning of the entire Public Administration, the SFE authorities—as legally designated for the resolution of this type of procedures—must resolve the registration update request efficiently and promptly; but, in the same way, they have the supreme obligation to ensure phytosanitary protection as a matter of public interest.

It is also worth noting that many of the grievances raised by the claimant stem from a generic premise that the requirements are not sufficient and that the means are being facilitated so that, in their application (reduction of deadlines and competent authority), the traders of these products are favored. In this regard, this court observes that there is no appropriate foundation on the issue of requirements (which ones are sufficient and which are not) and the claimant does not refer to the eventual way in which the Administration (SFE) will exercise its powers. This, moreover, would not be the subject of an unconstitutionality action, but of a control that must be exercised by the entire Public Administration and the ordinary jurisdiction, so that the legally assigned powers are exercised with rigor and efficiency.

Nor is there any evidence in the questioned rule that this evaluation is performed by professionals in agronomy and that they lack the competence or the necessary expertise to make an appropriate assessment of the documentation submitted, always safeguarding the environment and people's health.

Regarding what the PGR stated, this Chamber considers that its presumptions equally stem from a mistaken premise, as it refers to "granting the registration certificate"; however, as has been explained, the regulation in question does not properly regulate the registration of products, since they are already on the market, but rather what is required is the updating of all the information in their registrations. Now, concerning the request for clarification made by the PGR, this Court deems it clear that, for everything concerning registration—which is not the case for the regulation under analysis—or the updating of information in the registrations, the legal institution of positive silence (silencio positivo) is not applicable. In our legislation, the application of positive silence has been allowed —from the moment the request has been submitted with its formal requirements, to the competent body, and in the manner required by law— only for those procedures of the administered party related to licenses, permits, authorizations, or when a specific standard explicitly authorizes it. The purpose of this legal concept is to provide the administered party with a regulated and expeditious way to resolve their requests when, for one reason or another, the Administration has delayed in providing legal certainty on what is required. However, for a long time this Court has been emphatic in pointing out that in environmental matters—not only for the protection of the environment itself, but also for the impact it has on people's health—positive silence does not operate. For example, since judgment **No. 1994-6332**, the following has been considered:

“The point under discussion in this amparo appeal is the applicability or not of the legal concept of positive silence regarding the license or authorization requested—by the appellant—for the scientific collection of red macaws. In this regard, this constitutional body has held that, in general terms, positive silence operates in the face of the Administration's inertia and in those cases where the requester has fulfilled all the requirements for its granting, **the truth is that the protection and preservation of the integrity of the natural environment is a fundamental right, so it cannot be understood that positive silence applies simply due to the passage of the deadline within which the Administration should have ruled** on the permit for obtaining wild specimens of 'Ara Macao' for scientific purposes for conservation in the Central Pacific region. Hence, the Fundación Pro Iguana Verde cannot derive subjective rights in application of the aforementioned legal institution, since the public interest represented by the State regarding its obligation to ensure the right of every person to enjoy a healthy and ecologically balanced environment prevails over the private interest in the exploitation of wildlife”. (Criterion reiterated in judgments numbers 1999-01149, 2000-01375 and 2006-14479).

Such considerations were replicated by this Chamber in judgment **No. 2016-017375** which concluded the following: “it has also been stated with clarity that, in this environmental matter, the concept of positive silence does not operate either”.

In matters of drug registration—which clearly has an impact on people's health—the Chamber has also warned of the inapplicability of positive silence.

In judgment <span style="font-family:'Times New Roman'; font-weight:bold">n.°2006-000688</span><span style="font-family:'Times New Roman'"> the following reflections were set forth:</span></p><p style="margin-top:0pt; margin-left:28.35pt; margin-bottom:0pt; text-align:justify"><span style="font-family:'Times New Roman'; font-style:italic">“The importance encompassed by this precious right, as well as the duty of the Administration granted at the constitutional level to ensure its protection, leads to the conclusion that it would be contrary to the Social State of Law advocated by our Magna Carta to permit the application of the concept of positive silence (silencio positivo) in the matter of drug registration. This Constitutional Chamber considers that the aforementioned drug registration procedure carried out by the Ministry of Health requires a meticulous technical analysis that allows for a certain conclusion as to whether the product in question does not represent a danger to the health of the country's inhabitants; for this reason, it is essential that this proceeding be carried out efficiently. In light of the foregoing, this Chamber deems it necessary to clarify that the figure of positive silence (silencio positivo), especially in cases such as the present one, can in no way be conceived as the simple passage of the deadline during which the Administration should have ruled on a matter; this is because the protection of the right to health is at stake (in this regard, see resolution No. 1999-1149 of 7:33 p.m. on February 17, 1999)”.</span></p><p style="margin-top:0pt; margin-bottom:0pt; text-align:justify; line-height:150%; font-size:14pt"><span style="font-family:'Times New Roman'; -aw-import:ignore"> </span></p><p style="margin-top:0pt; margin-bottom:0pt; text-align:justify; line-height:150%; font-size:14pt"><span style="font-family:'Times New Roman'">This Chamber's jurisprudential guidelines on environmental matters were codified in the Forestry Law (Ley Forestal) n.°7575 of April 16, 1996, which states the following: </span></p><p style="margin-top:0pt; margin-left:28.35pt; margin-bottom:0pt; text-align:justify"><span style="font-family:'Times New Roman'; font-style:italic">“Art. 4.- Positive silence (silencio positivo)</span></p><p style="margin-top:0pt; margin-left:28.35pt; margin-bottom:0pt; text-align:justify"><span style="font-family:'Times New Roman'; font-weight:bold; font-style:italic; text-decoration:underline">In matters of natural resources, positive silence (silencio positivo) shall not operate</span><span style="font-family:'Times New Roman'; font-style:italic">, as contemplated in articles 330 and 331 of the General Law of Public Administration.</span></p><p style="margin-top:0pt; margin-left:28.35pt; margin-bottom:0pt; text-align:justify"><span style="font-family:'Times New Roman'; font-style:italic">When the State Forest Administration does not resolve matters submitted to its knowledge within the deadlines stipulated in the General Law of Public Administration, the responsible official shall be subject to the sanctions provided by law”.</span><span style="font-family:'Times New Roman'"> (Thus amended by article 1 of law n.°10072 of November 18, 2021. The emphasis does not correspond to the original). </span></p><p style="margin-top:0pt; margin-bottom:0pt; text-align:justify; line-height:150%; font-size:14pt"><span style="font-family:'Times New Roman'; -aw-import:ignore"> </span></p><p style="margin-top:0pt; margin-bottom:0pt; text-align:justify; line-height:150%; font-size:14pt"><span style="font-family:'Times New Roman'">Likewise, they were collected in the recent reform made to the Law for the Protection of Citizens against Excessive Requirements and Administrative Procedures n.°8220, which, as relevant, warns the following: </span></p><p style="margin-top:0pt; margin-left:28.35pt; margin-bottom:0pt; text-align:justify"><span style="font-family:'Times New Roman'; font-style:italic">“</span><span style="font-family:'Times New Roman'; font-weight:bold; font-style:italic; text-decoration:underline">Excluded from the application of positive silence (silencio positivo) are licenses, permits, and authorizations in matters of public health and the environment</span><span style="font-family:'Times New Roman'; font-style:italic"> and those matters in which, by constitutional provision, law, or judicial jurisprudence, it is expressly so indicated. Each institution must expressly indicate, in the National Catalog of Procedures, for which specific cases this figure is not applicable, under penalty of incurring an administrative fault by the Procedure Simplification officer”.</span><span style="font-family:'Times New Roman'"> (The emphasis does not correspond to the original). </span></p><p style="margin-top:0pt; margin-bottom:0pt; text-align:justify; line-height:150%; font-size:14pt"><span style="font-family:'Times New Roman'; -aw-import:ignore"> </span></p><p style="margin-top:0pt; margin-bottom:0pt; text-align:justify; line-height:150%; font-size:14pt"><span style="font-family:'Times New Roman'">Therefore, in accordance with the reiterated jurisprudence of this Chamber and the current legal regulations, it is held that in the case of procedures related to the registration or updating of pesticides, due to their clear impact on the environment and people's health, the administrative figure of positive silence (silencio positivo) does not apply. </span></p><p style="margin-top:0pt; margin-bottom:0pt; text-align:justify; line-height:150%; font-size:14pt"><span style="font-family:'Times New Roman'">Finally, it should be emphasized that if the trading parties do not comply with this procedure for updating requirements within the established deadlines, the Administration is empowered to apply the legal provisions on the matter and may cancel the registration (art. 24) and the person is exposed to the corresponding fines (art. 76, both of the Law on Phytosanitary Protection). </span></p><p style="margin-top:0pt; margin-bottom:0pt; text-align:justify; line-height:150%; font-size:14pt"><span style="font-family:'Times New Roman'; font-weight:bold">X.- </span><span style="font-family:'Times New Roman'; font-weight:bold; text-decoration:underline">REGARDING ART. 3</span></p><p style="margin-top:0pt; margin-bottom:0pt; text-align:justify; line-height:150%; font-size:14pt"><span style="font-family:'Times New Roman'">The </span><span style="font-family:'Times New Roman'; font-weight:bold; text-decoration:underline">claimant</span><span style="font-family:'Times New Roman'"> asserts that, again, the ministerial office shortens the time established in Executive Decree n.°39995 for the benefit of users, without it being known whether there is a technical study of workloads that supports such a decision to go from three months to ten days for the technical evaluation to be carried out by SFE officials, since in this decree they unilaterally exclude the corresponding ministries from participation in health and environmental matters. </span></p><p style="margin-top:0pt; margin-bottom:0pt; text-align:justify; line-height:150%; font-size:14pt"><span style="font-family:'Times New Roman'">They specifically question the paragraph that states that “for formulated pesticides that do not have a technical grade active ingredient registration associated with that formulation and whose manufacturer of that formulated product has been updated in accordance with this regulation, the SFE will grant the technical grade active ingredient registration certificate”. They consider that this decree opposes any active scientific technical principle governing registration matters, as it is granting a registration without even the basic process that governs registration regulations, which is chemical evidence. </span></p><p style="margin-top:0pt; margin-bottom:0pt; text-align:justify; line-height:150%; font-size:14pt"><span style="font-family:'Times New Roman'">Regarding this article, the </span><span style="font-family:'Times New Roman'; font-weight:bold; text-decoration:underline">Minister of MAG</span><span style="font-family:'Times New Roman'"> reiterates their technical explanation regarding the purpose of this regulation:</span></p><p style="margin-top:0pt; margin-left:28.35pt; margin-bottom:0pt; text-align:justify"><span style="font-family:'Times New Roman'; font-style:italic">“As we had already indicated, in Costa Rica before January 10, 2007, the registration system established that a formulation could be registered without the need for a registration of the raw material, that is, of its technical grade active ingredient (IAGT). After that date, it was established that every formulation, prior to being registered, required the registration of its IAGT. This means that currently a huge number, around fifteen hundred formulated products, are not associated with a manufacturer. That is why Executive Decree N° 39995-MAG of December 15, 2016, and its reform (Executive Decree N° 41481-MAG of December 10, 2018, published on January 11, 2019, supplement number 8 of the Official Gazette La Gaceta), establishes an updating process that will allow the registration system to guarantee that every formulation marketed in the country will be associated with a manufacturer of the IAGT. In such a way that this update of the manufacturer does not imply that a registration is being granted to a new product, but rather that through this updating process the authority will have the necessary information to determine if the technical material with which that formulated product is made does not contain relevant impurities and that it also complies with the international specification that every IAGT must meet for the formulation of pesticides. Therefore, what the claimant indicates regarding the lack of technical or scientific basis and the confusion made with the registration under the equivalence modality is incorrect, since the process does not propose an equivalence but rather an update of the information of a current registration of a formulated product that does not have a manufacturer of the IAGT associated with its registration, remembering that by virtue of article 3, it is not that a new product is being authorized but rather that a manufacturer is being associated with that formulation that already has a registration and is marketed in the country”.</span></p><p style="margin-top:0pt; margin-bottom:0pt; text-align:justify; line-height:150%; font-size:14pt"><span style="font-family:'Times New Roman'; -aw-import:ignore"> </span></p><p style="margin-top:0pt; margin-bottom:0pt; text-align:justify; line-height:150%; font-size:14pt"><span style="font-family:'Times New Roman'">Furthermore, it refers to the fact that the questions about aspects of deadlines and workloads are discussions of mere legality and not of constitutionality. </span></p><p style="margin-top:0pt; margin-bottom:0pt; text-align:justify; line-height:150%; font-size:14pt"><span style="font-family:'Times New Roman'">The </span><span style="font-family:'Times New Roman'; font-weight:bold; text-decoration:underline">rule</span><span style="font-family:'Times New Roman'"> in question, comparatively with the previous one, provides the following:</span></p>

<p style="margin-top:0pt; margin-bottom:0pt; text-align:justify; line-height:150%; font-size:14pt"><span style="font-family:'Times New Roman'; -aw-import:ignore"> </span></p><p style="margin-top:0pt; margin-bottom:0pt; text-align:justify; line-height:150%; font-size:14pt"><span style="font-family:'Times New Roman'">In relation to the grievances raised, the </span><span style="font-family:'Times New Roman'; font-weight:bold; text-decoration:underline">Chamber</span><span style="font-family:'Times New Roman'"> observes that the arguments about the definition of deadlines and the workloads of the SFE and the exception to the participation of the Ministries of Health and Environment and Energy have already been addressed in the previous sections. The mere circumstance that the resolution deadlines are reduced does not in itself imply an injury to the Law of the Constitution, and the fact that the competencies for updating registrations are concentrated in the SFE is a consequence of a legal provision (art. 23 of the Law of the State Phytosanitary Service), which does not inherently show any indication of unconstitutionality nor has it been challenged.</span></p><p style="margin-top:0pt; margin-bottom:0pt; text-align:justify; line-height:150%; font-size:14pt"><span style="font-family:'Times New Roman'">Regarding the registration, the explanations of the minister must be recalled, in the sense that this procedure does not imply as such granting a new registration, but rather updating all the missing information of the product, which allows the authorities to determine if it contains relevant impurities that warrant some kind of reassessment of the registration. As has been repeatedly emphasized, the procedure regulated by the rules under examination is for products that are already registered and on the market (an administrative authorization already exists), so information is requested for the purpose of its re-evaluation. Furthermore, as seen in the reports transcribed in this judgment, previously the validity of registrations was provided for indefinitely, whereas the rules under analysis introduce caps and limits to that registration. </span></p><p style="margin-top:0pt; margin-bottom:0pt; text-align:justify; line-height:150%; font-size:14pt"><span style="font-family:'Times New Roman'; font-weight:bold">XI</span><span style="font-family:'Times New Roman'; font-weight:bold; text-transform:uppercase">.- REGARDING ART. 4 (</span><span style="font-family:'Times New Roman'; font-weight:bold">which reforms art. 5 of decree n.°39995</span><span style="font-family:'Times New Roman'; font-weight:bold; text-transform:uppercase">)</span></p><p style="margin-top:0pt; margin-bottom:0pt; text-align:justify; line-height:150%; font-size:14pt"><span style="font-family:'Times New Roman'; font-weight:bold; text-decoration:underline">The claimant</span><span style="font-family:'Times New Roman'; font-weight:bold"> </span><span style="font-family:'Times New Roman'">insists that the registration facilitation process established by Executive Decree n.°414131 goes against the State's duty to protect all of Costa Rican society. They estimate that requirements are merely listed to get by, and that they will not support any information to perform a technical-scientific risk analysis evaluation. </span></p><p style="margin-top:0pt; margin-bottom:0pt; text-align:justify; line-height:150%; font-size:14pt"><span style="font-family:'Times New Roman'">The </span><span style="font-family:'Times New Roman'; font-weight:bold; text-decoration:underline">Minister of MAG</span><span style="font-family:'Times New Roman'"> explains that in analyzing art. 5, the claimant confuses the concept of manufacturer with that of formulator, in such a way that the entire hypothesis, the objections, and the analyses made of said rule are not applicable to the legal situation regulated by the update of formulators in Executive Decree n.°39995-MAG of December 15, 2016, and its reform n.°41481-MAG.</span></p><p style="margin-top:0pt; margin-bottom:0pt; text-align:justify; line-height:150%; font-size:14pt"><span style="font-family:'Times New Roman'">The rule in question, comparatively with the previous one, provides the following:</span></p>

The qualitative-quantitative composition certificate for the formulated product must be issued by the new formulator, when the formulator has changed.

3-A sworn statement (declaración jurada) from the registration holder, attesting that the process and formulation composition are maintained and that a TGAI authorized by the CA is used, either because said TGAI is previously registered as such, or is subject to the provisions of this decree.

4-Within a period of 8 business days, counted from the notification of the resolution approving the requested update, the draft label and leaflet project for the formulated product must be submitted, containing the information indicated in the Central American Technical Regulation No. RTCA 65.05.67. 13: Agricultural Inputs. Technical Grade Active Ingredient, Formulated Chemical Pesticides, Related Substances, Adjuvants and Physical Vehicles for Agricultural Use. Requirements for the Preparation of Labels and Leaflets. Resolution No. 365-2015 (COMIECO LXXII). The State Phytosanitary Service (Servicio Fitosanitario del Estado, SFE), within a period of five business days, will review and notify the approval of the identification project.

5-Proof of payment of the current fee. Being an update of a current registration, update requests for formulators submitted under this article shall not pay the fee established for modifications to the registration.

(Thus amended by Art. 4 of Executive Decree No. 41481 of December 10, 2018) In the Chamber's (Sala) opinion, the plaintiff does not properly substantiate the reasons why they consider that the requirements demanded therein "will not support any information for conducting a technical-scientific risk analysis (análisis de riesgo)". It is a generic argument, so this Court cannot conduct a rigorous constitutional review on the matter.

Furthermore, it is necessary to reiterate this Chamber's criterion in judgment No. 2009-008917, which established the following:

"In the first place, the plaintiffs request that the unconstitutionality of articles 1, 7, and 8 of Law number 8702, called Processing of Agrochemical Registration Applications, be declared, arguing that the law does not require a series of essential technical requirements that, in their opinion, must be required in order to register an agrochemical, and therefore these omissions violate the fundamental rights to health and a healthy and ecologically balanced environment. In this regard, it is worth mentioning that although this Constitutional Court is empowered to act as a negative legislator, with the power to annul from the legal system all those norms it considers unconstitutional, the truth is that it is prevented from acting as a positive legislator creating norms. On the other hand, even though this Chamber is competent to hear legislative omissions as established in Article 73 of the Law of Constitutional Jurisdiction, it is important to clarify that not every normative omission can be challenged through this means. In that sense, only those omissions that occur as a consequence of an express and direct mandate contained in constitutional law can be subject to constitutional control by way of action. Now, in the specific case, the omissions challenged by the plaintiffs do not come from an express mandate of the constituent power; rather, they are omissions they say they find in the text of the law, without the duty to legislate in the sense explained by the actors coming from the Political Constitution. Likewise, as this is a Court that acts as a negative legislator, it is clear that an eventual favorable ruling, with the consequent elimination of the norm, would not remedy the omissions indicated by the plaintiffs, so the action filed in those terms lacks utility and is therefore manifestly inappropriate. On the other hand, it is observed that, in essence, what the plaintiffs intend is for this Chamber to determine whether the requirements that the norms demand for the registration of an agrochemical are technically and scientifically appropriate or not and, if not, to rule on the list of requirements that in their opinion the regulations should contain. However, it is necessary to indicate that this Court is not the competent body to exercise that function, as this is a competence assigned to the legislator, who, in use of their discretionary powers, is responsible for designing the legal procedures and requirements that must be met for the registration of agrochemicals in the country. Only in those cases where the legislator exceeds that discretionary power to the direct detriment of the fundamental rights of persons can this Chamber validly hear and rule on the matter. However, as in this case what is challenged is not the text of the norms themselves or the legislator's discretion, but what in the opinion of the actors the law omits, this Court cannot rule with the purpose of supplanting competences and establishing those requirements. Under such circumstances, the action is inadmissible." (The highlighting does not correspond to the original).

This ratio must be replicated in the specific case insofar as, as was noted, there is no precision in the plaintiff's substantiation, and the Chamber cannot arrogate the power to make technical and scientific determinations about whether the requirements demanded in the numeral in question are or are not sufficient to fulfill the legislator's mandate and the constitutional mandates derived from Articles 21, 46, and 50 of the Constitution.

XII.- Regarding Art. 5 (which amends Art. 6 of Decree No. 39995) The plaintiff affirms that the chemical equivalence (equivalencia química) process proposed in this article contradicts international standards, Constitutional Chamber judgment No. 2011-016937, and the CGR's reports. They argue that a procedure for evaluating the equivalence in formulated products has not been proposed by these institutions. Furthermore, they question that the database does not constitute any solution.

The Minister of MAG responded to these grievances by explaining that Art. 6 of the challenged decree guarantees, in its current wording, first that Costa Rica will cease to have registrations of indefinite duration, because from the update, all TGAI and formulated product registrations will have a validity of ten years, imposing the obligation to renew them and not as it is now where, being of indefinite duration, they do not have to be renewed for not having an expiration date; second, that all formulations sold on the market currently will have an associated manufacturer and not as it is now where the manufacturing sites and origins of raw materials are unknown; third, that every TGAI used in Costa Rica for the formulation of authorized products to be marketed in Costa Rica has its purity accredited and does not have relevant impurities above the international specification; fourth, that all TGAIs used in Costa Rica comply with the international conventions signed by Costa Rica (Annex III of the Rotterdam Convention, the Stockholm Convention, or the Montreal Protocol); and fifth, that the SFE will create a database of toxicological, ecotoxicological, and environmental fate information for the technical grade active ingredients that are registered and that do not have current test data protection periods. He affirms that it is very important for the SFE to have an information bank for molecules that are not new and whose test data are free to use because they do not have current protection periods. Furthermore, it is necessary for companies that have toxicological, ecotoxicological, and environmental fate information for technical grade active ingredients that are not new to contribute information they have managed to collect and that serves so that in the future the SFE can build a complete toxicological, ecotoxicological, and environmental fate and behavior profile, allowing for a reference profile for registrations by equivalence.

Regarding this, the PGR maintained that by not precisely establishing the rules to which the competent authority must adhere to verify the information, it is possible that the updating of registrations with referenced information that does not meet the indicated requirements may be permitted, and, therefore, this would imply the updating of product registrations without a prior evaluation of the environmental and health risks of their application. If this is confirmed, according to the technical criteria issued to that effect, this would imply the unconstitutionality of the articles that allow the use of referenced information without an adequate determination of equivalence.

The norm in question, comparatively with the previous one, provides the following:

In relation to the plaintiff's claims, this Chamber considers that they are omitted and confusing and that it is not appropriate to supply the argumentation that would correspond to the former to make. This Court has already noted the following:

"The Chamber could not, for example, incur in judicial activism or substitute the plaintiff in their duty to argue. For this reason, also, the judgment must be '… congruent with what is sought …' in the filing brief." (Judgment No. 2022-026592).

In the sub lite, the plaintiff indicates that there is no procedure for the evaluation of equivalence; however, they omit to point out which instruments require that, in addition, the authorities must detail a procedure for the evaluation of equivalence, thus preventing this Chamber from conducting a rigorous analysis of the issue. In any case, this mechanism, that of using reference profiles (perfiles de referencia), was examined in another action that was dismissed in judgment No. 2022-26651. It was also extensively assessed in judgment No. 2022-023238, in which it was explained that it is not an automatic procedure but requires an adequate analysis and substantiation, which must be controlled in each specific case. Consequently, this Chamber refers to the considerations made in those resolutions.

For the rest, it is appreciated that the norm under analysis also requires that, in the absence of the equivalence report, it be verified that the TGAI does not contain relevant impurities at levels higher than international standards or specifications, as well as that the technical grade active ingredient is not included in Annex III of the Rotterdam Convention, the Stockholm Convention, or the Montreal Protocol. Thus, standards for conducting the analysis in question are expressly established. The SFE authorities, as has been noted, must be diligent and demanding in the matter given that people's health and the healthy and ecologically balanced environment are at stake. Therefore, in the registration and information update procedure, said authorities are obliged to apply the highest standards of protection to those fundamental rights and to be respectful of the precautionary principle (principio precautorio). Likewise, they are obliged to update themselves and adjust to technical novelties or international standards in phytosanitary protection. Indeed, as already noted supra and it is appropriate to insist, this Chamber draws attention to warn that – given the slightest trace of doubt – they must require all documentation or studies that are pertinent, with the purpose of verifying that the product for which the registration is to be updated meets the parameters and conditions necessary to safeguard human health and food safety. Likewise, it is required of them to ensure that its use is appropriate and has the desired effects. The rigor in the selection of studies is just as important as the subsequent controls that can be carried out in the application and use of the products.

Consequently, from what the plaintiff pointed out, an injury to the Law of the Constitution is not proven.

XIII.- Regarding Art. 6 (which amends Art. 7 of Decree No. 39995) The plaintiff accuses that this article contains an unscientific registration proposal, which departs from national and international standards, and could be unconstitutional as it is harmful to the precautionary principle. They argue that the Executive Branch promulgated this decree which, in congruence with its objective, should have been titled "regulation for registration facilitation", where the priority is the update or renewal of registration with referenced information, pressuring registration analysts by shortening response times, proposing the registration process with just a simple verification of the information, and separating the Ministries of Health and Environment in their registration analysis.

The Minister of MAG states that the current text bears no relation or congruence with the comments and reckless affirmations made by the plaintiff about this specific article. Regarding the assertion that this norm inverts the principle of the burden of proof or the precautionary principle, he rejects it "in an absolute and categorical manner", not only because it is a matter of legality to be discussed in the ordinary jurisdiction, but because the current text of Art. 7 is supported by reiterated opinions of the PGR and by judgments of the Constitutional Chamber. He reiterates that it is incorrect and reckless to indicate, as the plaintiff does, that the questioned decree violates the precautionary principle in environmental matters, just as it is incorrect to affirm, as the plaintiff does in this fact and in their arguments, that the burden of proof is inverted.

He points out that the norm under action does not allow or make it possible to grant registrations for new products to those already marketed, as its scope of application is very clear and is only feasible to apply to current registrations that have been granted under regulations (legal or regulatory) different from Executive Decree No. 3495-MAG-SMINAE-MEIC and its amendments. He adds that with this regulation, TGAI registrations will not be granted, and much less registrations for formulations that are not already on the market. Regarding the agrochemicals registered and currently marketed in the country, there is no additional danger resulting from their application concerning human health, the environment, or the biological efficacy of the pesticide. Therefore, it is not correct to maintain that, with the application of the decree, the registrations updated in their dossiers imply an additional risk to health, the environment, or agriculture, since all, absolutely all, the TGAI registrations granted must, necessarily and inevitably, correspond to one of the formulations already sold on the market, and over these formulations, the Ministries of Health or Environment have broad and indisputable competences and powers to adopt the pertinent measures to prevent damage to health or the environment.

The PGR reiterates that this does not weaken the constitutional duty that, by virtue of the precautionary principle, the competent authorities have to apply the powers set forth in Arts. 25 and 30 of the Phytosanitary Protection Law and Art.

Article 5 of the Law on the Importation and Quality Control of Agrochemicals, to "deny, suspend, or cancel the registration of chemical, biological, or related substances," "restrict or prohibit the importation, transit, redestination, manufacturing, formulation, repackaging, rewrapping, storage, sale, mixing, and use of chemical, biological, or related substances and application equipment for agricultural use, when justified for technical reasons," and "prohibit the circulation or order the destruction of products that do not comply with quality standards, as well as take other measures aimed at improving the quality of agrochemicals." The regulation in question, comparatively with the previous one, provides the following:

In the opinion of the Chamber, contrary to what was stated by the petitioner, which is actually a reiteration of the previously examined defects, the provision in question authorizes the SFE to initiate the corresponding administrative procedures for the annulment of the registration—it should be remembered that this regulation applies to products already in use in the market—and, furthermore, reiterates the possibility of exercising the powers legally granted in this matter. The fact that the amendment to the decree in question does not expressly cite the "competent ministries," but instead centralizes the oversight authority, as established in the law, in no way means that other powers legally granted to other ministries, which would authorize them to adopt administrative measures to safeguard human health or the environment, are disregarded.

It should be remembered that the management of the registration is the competence of the SFE, so it is logical that this authority is the one tasked with initiating the corresponding procedure for the annulment of the registration. In this regard, emphasis must be placed on the legal authority established in Article 30 of the Phytosanitary Protection Law, which precisely charges the MAG with the decision to restrict or prohibit the importation, transit, redestination, manufacturing, formulation, repackaging, rewrapping, storage, sale, mixing, and use of chemical, biological, or related substances and application equipment for agricultural use, when justified for technical reasons and it is considered that using them is harmful to agriculture, health, or the environment. Thus, the challenged regulatory provision is a reflection of that police power provided for the MAG.

However, none of what is said in the challenged article nullifies other legal competences that, as noted *supra*, are matters of public order and could, for example, urge the MAG or present the corresponding evidence so that the SFE initiates the procedure that concerns it. It should be remembered, as already noted *supra*, that phytosanitary protection measures are rooted in our Social State of Law, as they seek to protect health (Article 21), the protection of consumer rights specifically regarding health and the environment (Article 46), as well as the stimulation of agricultural production, so important for our country, alongside the protection of the environment (Article 50). Thus, the authorities must carry out oversight jointly.

For example, the General Health Law contains the following powers in favor of the Ministry of Health:

*"Art.- 213.- Every person, natural or legal, engaged in the production of food must do so under sanitary environmental conditions and using defense or conservation techniques approved by the health authority, in order to avoid, principally, the contamination of such products and their hazardousness due to the presence of toxic residues from their treatment with pesticides or other defense or conservation systems."* *"Art.- 244.- Natural and legal persons who import, manufacture, handle, store, transport, trade, supply, or apply substances, mixtures of substances, or products called pesticides under the plant health law shall be subject to the regulatory provisions that the Ministry issues in common agreement with the Ministry of Agriculture for the protection of people's health in accordance with that law; interested parties must register every pesticide or product intended for the control or extermination of infestations and request prior permission to operate when such substances, mixtures of substances, or products, which by their nature or use are not included in the aforementioned law, are capable in any way of producing intoxications or serious damage to the health of people or animals useful or harmless to man."* *"Art. 245.- Natural or legal persons engaged in pest control may operate only with the permission of the Ministry, using the substances, mixtures of substances, products, and mixtures of products authorized by the Ministry and subject to the applicable technical standards, in order to avoid accidents or damage to the health of persons performing such tasks or third parties."* (The highlighting does not correspond to the original).

Likewise, the Organic Law of the Environment provides the following:

*"Article 59.- Environmental contamination. Contamination is understood as any alteration or modification of the environment that may harm human health, threaten natural resources, or affect the Nation's environment in general. The discharge and emission of pollutants shall be adjusted, obligatorily, to the technical regulations issued. The State shall adopt the measures that are necessary to prevent or correct environmental contamination."* *"Article 60.- Prevention and control of contamination. To prevent and control environmental contamination, the State, the municipalities, and other public institutions shall give priority, among others, to the establishment and operation of adequate services in fundamental areas for environmental health, such as:* *a) The supply of water for human consumption.* *b) The sanitary disposal of excreta, wastewater, and stormwater.* *c) The collection and management of waste.* *d) The control of atmospheric contamination.* *e) The control of noise pollution.* *f) The control of chemical and radioactive substances.* *These services shall be provided in the manner determined by specific laws and regulations, seeking the participation of the population and its organizations."* *"Article 61.- Environmental contingencies. The competent authority shall issue the necessary preventive and corrective measures when environmental contamination contingencies and others not contemplated in this law occur."* (The highlighting does not correspond to the law).

In this way, it is pertinent to note that the fact that the challenged decree concentrates certain registration functions in the MAG, and specifically in the SFE, does not disregard or nullify other types of legally established competencies and authorizations in favor of the Ministry of Health and MINAE regarding the safeguarding of public health and the environment. It was previously noted that the decree under review cannot be understood as a normative body isolated from the rest of the legality and constitutionality framework, and that the specific task of updating registration information and its review does not entail nullifying the other legal competences entrusted to other ministerial portfolios.

Similarly, it is worth reiterating what was stated in the precedent transcribed *supra* No. 2017-06668, to the effect that to invalidate a previously processed registration, the demonstration of an unacceptable risk to human health, the environment, or agriculture is required, and it contemplates an enforcement power of the public administration, such as the restriction or prohibition of a registration's use, even if a prior substantive legal situation exists in favor of the administered party, such as the registration. To this extent, the granted registration can be modified if there is evidence of an unacceptable risk, in which case the Administration—understood in a broad sense—would be enabled to exercise enforcement powers and impose precautionary measures.

Therefore, a violation of the invoked precautionary principle is ruled out, and the grievance in question is rejected.

**XIV.- Regarding Article 9 (which amends and adds a new Article 11 of Decree No. 39995).** The petitioner claims that, continuing with the registration facilitation process and without any analysis based on technical and scientific support in accordance with national and international standards, the Executive Branch proposes to homologate the uses of a product with another that has similarity in the active ingredient, concentration, and formulation, when in this particular case the minimum that can be done is the chemical equivalence of the active ingredient, but since it refers to a formulation, the co-formulants must be analyzed, which must be declared and allow for risk analysis by the ministries of health and environment and present a biological efficacy study respecting the univocal rules of science and technique.

The Minister of MAG states that the petitioner association provides nothing more than a transcription of parts of a CGR report that is absolutely decontextualized and not applicable to the specific situation. He indicates that the homologation of formulations proposed in Article 11 of the challenged decree is based on the FAO and WHO manual of specifications for the development of pesticide specifications.

The challenged provision establishes the following:

*"Article 9.- Article 11 is amended and a new one added, and the numbering of subsequent articles is adjusted:* *'ARTICLE 11. Within a period of thirty-six months, counted from the effective date of this amendment, the holders of registrations for formulations with a valid registration may request the State Phytosanitary Service to homologate the label and pamphlet, with respect to other already registered formulations of the same type, with the same IAGT and equal concentration, in aspects related to authorized uses, pests, approved crops, doses, modes of application, application ranges, and application intervals.* *The State Phytosanitary Service, through the agronomic evaluation area of the Registration Unit, shall, within a period of thirty days, make an assessment of each specific case and verify that the value of the physicochemical properties of the formulated product meets the parameters established in the technical regulations in force in the country or those of the FAO or other international reference organizations to which the already registered material is presented. The resolution approving or denying the request shall be issued within a period of thirty days counted from the presentation of the agronomic evaluation report. Together with the homologation request, the chemical physical properties of the formulation, the pamphlet, and the label incorporating the requested changes must be provided."* In the opinion of the Chamber, the deficiency in the argument is that the petitioner again intends for this Court to technically dictate how to perform the procedure to evaluate products with respect to other already registered formulations of the same type with the same IAGT and equal concentration. This corresponds to an entirely technical decision regarding which it lacks competence to make a determination. It appears, undoubtedly, like a discussion of legality and not of constitutionality. It should be noted that this is about the homologation of labels and pamphlets for products that have notable similarities, so requesting a chemical equivalence study, as the petitioner intends without greater justification, does not seem reasonable. Consequently, the grievance must be dismissed, without prejudice to this being discussable more broadly in the ordinary channels of legality.

**XV.- CONCLUSION** As a corollary of the considerations made, it is necessary to dismiss the unconstitutionality action filed.

Magistrates Cruz Castro and Rueda Leal issue a dissenting vote and declare the action granted for violation of the right to a healthy and ecologically balanced environment. Magistrates Cruz Castro and Rueda Leal attach separate notes.

**XVI.-** **DOCUMENTATION PROVIDED TO THE CASE FILE**. The parties are warned that if they have provided any paper document, as well as objects or evidence contained in any additional electronic, computer, magnetic, optical, telematic device or one produced by new technologies, these must be removed from the office within a maximum period of thirty business days counted from the notification of this judgment. Otherwise, all material that is not removed within this period will be destroyed, pursuant to the provisions of the "Reglamento sobre Expediente Electrónico ante el Poder Judicial", approved by the Corte Plena in Session No. 27-11 of August 22, 2011, article XXVI and published in Boletín Judicial No. 19 of January 26, 2012, as well as in the agreement approved by the Consejo Superior del Poder Judicial, in Session No. 43-12 held on May 3, 2012, article LXXXI.

POR TANTO:

By majority, the unconstitutionality action is dismissed.

Magistrates Cruz Castro and Rueda Leal issue a dissenting vote and declare the action granted for violation of the right to a healthy and ecologically balanced environment. Magistrates Cruz Castro and Rueda Leal attach separate notes.

Fernando Castillo V.

Fernando Cruz C. Paul Rueda L.

Luis Fdo. Salazar A Jorge Araya G.

Anamari Garro V. Aracelly Pacheco S.

Res. nro. 2023002389 Dissenting vote of Magistrates Cruz Castro and Rueda Leal, with drafting by the latter. With the usual respect, we dissent and declare the action granted, for the following reasons.

As a starting point, we reiterate the criterion we expressed in judgment no. 2022-026651 of 4:30 p.m. on November 9, 2022, whose considerations are, to a large extent, applicable to the *sub lite*:

“***1.- Regarding the referenced use of data for registration.** The majority resorts to the “International Code of Conduct on the Distribution and Use of Pesticides. Guidelines for the Registration of Pesticides” (April 2010) to establish the “acceptability of harmonized and clear registrations, the use of available information and mutual acceptance of data, the existence of information exchange mechanisms between competent authorities” as a “key” element in that technical regulation and to allege the existence of the “principle of non-repetition of studies”. In that sense, it transcribes point 3 of the cited code:* *“3. Principles of pesticide registration* *The responsible authorities, when managing their national or regional registration programs, should follow a series of important principles that are practiced internationally. The acceptance and use of these principles will ensure greater efficiency, transparency, and optimal use of resources during the registration process. These principles include the following:* * *Complete, harmonized, and clear criteria and requirements for registration;* * *Use of all available information and mutual acceptance of data;* * *Transparency and information exchange;* * *Evaluation made on scientific bases to determine if precautionary measures are required;* * *Consideration of hazards;* * *Risk evaluation and mitigation based on the local situation;* * *Risk/benefit analysis, taking into account available alternatives;* * *Post-registration monitoring and evaluation;* * *Mechanisms for periodic and unscheduled reviews in order to respond to new information that may have an impact on the regulatory status;* * *Protection of the intellectual property rights of the application.* *The evaluation of data retained in the registration file should respect internationally accepted and agreed standards and procedures, to the extent they are available. These standards should be regularly updated to ensure their conformity with current scientific advances.* *It is essential that all steps of the registration process are transparent, based on well-reasoned and published criteria and guidance documents, with complete information shared with the applicant about the outcome of the different steps of the registration process. Responsible authorities should ensure that the criteria and requirements for registration are complete and clearly defined. The same applies to data acceptance standards, data quality, the acceptability of formulated pesticide products for specific users and uses, or the criteria for degradability or accumulation.* *Governments should facilitate the exchange of information between responsible authorities through national institutions, international, regional, and sub-regional organizations, as well as public sector groups. They should develop legislation and regulations to allow the exchange of information with the public on the risks and benefits of pesticides and also to facilitate public participation in the country's pesticide management.* *Responsible authorities should, whenever possible, use data that has been placed in the public domain, and preferably those that have been previously reviewed, when considering a registration application. In this way, duplicated work and inefficient use can be minimized. Mutual acceptance of data by various regulatory authorities on topics such as efficacy and residues, among others, is recommended, provided that a solid basis can be established to ensure that the data are relevant to the situation under consideration”* *Up to there went the majority's citation. We consider that an adequate assessment of the case requires, at least, the transcription of the two following paragraphs of that same numeral:* *“In addition, hazard assessments are generally globally applicable and are available from published sources, including peer evaluations by the FAO/WHO Joint Meeting on Pesticide Residues (JMPR). These can be used in the evaluation of a dossier, provided that data ownership is adequately taken into account.* *Countries should fully evaluate the efficacy of pesticides, their behavior, their final destination, their hazard and risk in relation to the various anticipated conditions of use in their country. Any registration procedure should include an evaluation of the potential risks related to the pesticide use for which the pesticide has been requested. The instructions for use, as indicated on the label, should cover these risks and prescribe measures for their proper application, storage, handling, and disposal to mitigate said risks. In doing so, responsible authorities should also ensure that these measures can be realistically adopted by the user for whom the product has been intended. Specific requirements under national policies for Integrated Pest Management (IPM) [5] and Integrated Vector Management (IVM) [6] should also be considered.” (Underlining added).* *Based on the foregoing, contrary to what the majority judgment concludes, we estimate that the full evaluation of the pesticide must be the rule. Our reading of that ordinal is that mutual acceptance of data is a recommendation (the standard textually states “Mutual acceptance of data… is recommended”) with the purpose of avoiding excessive procedures, such as duplicated work. However, the recognition of referenced information can never substitute the full assessment of the pesticide.* *The optional nature of the mutual acceptance of data is also derived from numeral 12 of the cited code, which subjects such acceptance to the relevance and quality of the data:* *“Mutual acceptance of data. If relevant data of good quality have been generated in other countries, the responsible authority could waive the requirement for generating local data. This is especially important for efficacy tests, residue data, and environmental field studies, all of which likely require the involvement of national (public) research institutions;”* *Such relevance and quality, or equivalence conditions, are found lacking in the challenged decree.* *The opposition of the undersigned to the use of referenced information, under the terms of the challenged norm, was shared by the then Minister of Environment and Energy, who expressed himself in this process in the following terms:* *“This section intends that those IAGTs that do not have their own information (generics) be updated, and subsequently registered, with the presentation of referenced information. This procedure is contradictory to the definition of referenced information established in Decreto Ejecutivo No. 40059-MAG-MINAE-S, which indicates "4.32. referenced information: For the application and interpretation of this regulation, it is the technical information from the reference profile, which may be used by the AC to evaluate the application for a registration of IAGT by equivalence and which does not have a valid protection period."* *For its part, the definition of reference profile indicates: "4.49. Reference profile or source: It is the information on which the risk analysis was based and for which a regulatory decision was made and the corresponding registration was granted, and which will be used as the basis for the equivalence registration, in accordance with the provisions of this regulation." The comprehensive reading of these two definitions demonstrates that equivalence cannot be determined if a duly evaluated and registered reference profile is not available, from which the referenced information is taken. This procedure is not applied, according to what DE 39995 cited contemplates, which contradicts the provisions of the CGR. The Contraloría General de la República (CGR) in its report FOE-AM-19/2004 pointed out the non-compliance with national and international regulations by the SFE by tolerating that registrants present information from other products (referenced information), without performing an equivalence analysis to verify if said information is applicable to the new substance to be registered. Based on its analysis, the CGR ordered: "Immediately suspend the practice of registering agricultural pesticides using information corresponding to another previously registered product, without having performed an equivalence analysis in accordance with the provisions of FAO and WHO...". Likewise, the Sala Constitucional in its Resolution No. 201101 6937 ordered the annulment of subsection b, and the reference in the penultimate paragraph to said subsection "b)" of section 7.3.2, of article 2, of DE 33495-MAG-S-MINAE-MEIC, because said numeral allowed equivalence to be made from a reference profile with incomplete data. It would be even worse to allow the updating of a registration with referenced data that has no direct relationship with the product to be updated, which would be being permitted by this regulation.”* *Finally, concerning the use of existing evaluations of the same active ingredient and/or product, it should be noted that the aforementioned code reduces the possibilities of such practice to specific cases:* *“6.3 Use of existing evaluations of the same active ingredient and/or product* *In the event that the applicant owns the data or can fully justify the right to use the data for their registration application, there are elements of existing registrations that can be used for new applications based on the same active ingredients. However, if the data are owned by another proprietor and the applicant cannot justify their right to use them, the responsible authority should not use the data and the evaluation of the first registrant to approve the second applicant's product.” (Underlining added).* *In that regard, we consider that the challenged regulation undermined the protection of the environment and public health by enabling the use of referenced information, to the detriment of a full assessment of the pesticide or product.* ***2.- As to the reduction of requirements.** Regarding this topic, the majority of the Chamber chose to consider that the action lacks adequate grounding. In this respect, we indicate, on the one hand, that the lack of grounding should have been noticed and warned by the Chamber in a timely manner, under the terms of article 80 of the Ley de la Jurisdicción Constitucional. We recognize that the lack of grounding can lead to the action being dismissed when it is examined on its merits.* However, such a course of action should occur only when it is not clearly evident from the case record that the claim is procedurally proper, as occurs in the sub lite case.

*Thus, on this matter, the Office of the Attorney General of the Republic (Procuraduría General de la República) stated:* *“…from a reading of Article 1 of the questioned Decree, it is possible to determine that the revalidation process established therein requires fewer requirements than those set forth in the revalidation process established by Decree 33495, since the latter required, in all cases, the confidential information dossier, the administrative dossier, as well as the acute toxicity studies defined in subparagraphs d.1.1, d.1.2, d.1.3, d.1.4, d.1.5, d.1.6, and the ecotoxicity studies defined in subparagraphs d.5.1.1, d.5.3.1, d.5.4.1, of section 7.2.* *Note that for cases in which the product manufacturer has not changed, the challenged Decree only requires the application for updating the manufacturer, the registration certificate issued by the authority of the country of origin, the qualitative-quantitative composition certificate, and proof of payment of the current fee.* *For cases in which the product manufacturer has changed, although other requirements are demanded, these continue to be fewer than those established by Decree 33495. Furthermore, it is permitted that the technical dossier information be presented through referenced information and demands acute toxicity studies only when the technical grade active ingredient (IAGT) contains relevant impurities at levels higher than recognized international standards, or that are in Annex III of the Rotterdam Convention, or in the Stockholm Convention, or in the Montreal Protocol.* *That is, the revalidation process of Decree 33495 required certain technical requirements that have not been contemplated by Decree 39995, despite the fact that the recitals (considerandos) of the latter acknowledge that it concerns the updating of products that have not met the toxicological, ecotoxicological, and environmental fate information requirements established in international regulations and required since the entry into force of Decree 33495.”* *For its part, the director of the Directorate of Environmental Quality Management (Dirección de Gestión de Calidad Ambiental) of the Ministry of Environment and Energy (MINAE) pronounced as follows:* *“DE N° 39995-MAG was issued arbitrarily and unilaterally by MAG in order to complete the dossiers of old products, including the registration of the technical grade active ingredients (IAGT) that support said formulated products (which under previous regulations did not have to be registered), as well as to define new validity periods for these old products. However, in clear non-compliance with the provisions of the CGR in report FOE-AM-19/2004, the participation of MINAE or the Ministry of Health was NOT contemplated, nor were the regulated parties asked to submit all of the studies required to carry out the environmental and health evaluation, established in DE N° 33495-MAG-S-MINAE-MEIC and DE N° -40059-MAG-S-MINAE. Similarly to what was established in DE N° 24997 and Law N° 8702, it was also not considered that the insufficient studies required in DE 39995 be analyzed by the competent authority in environmental or health matters, which means that these products continue to be marketed without an opinion that guarantees the protection of the environment and human health.” (The underlining is added. Official note DIGECA-516-2018 of December 19, 2018). * ***3.- Regarding the precautionary principle and the reversal of the burden of proof.** This topic was covered in our dissenting opinion to judgment No. 2017-06668 of 10:50 a.m. on May 10, 2017, in the following terms: * *“Dissenting opinion of Magistrates Cruz Castro and Rueda Leal, drafted by the latter. With customary respect, we separate from the majority opinion for the following reasons.* *In its filing brief, the claimant explains that Article 7 of the challenged Regulation contradicts the precautionary principle and reverses the burden of proof in environmental matters. It reaches this conclusion because the numeral in question requires the competent ministries to “…demonstrate an unacceptable risk to human health, the environment, or agriculture…” so that the Sanitary Service can restrict or prohibit the use of a registration.* *In the judgment, the majority of this Court considered that the claim was not procedurally proper because the questioned rule rather protected the environment. In that sense, the resolution argues that the moment for applying the precautionary principle is during the processing of a registration’s inscription. Once the registration is inscribed, it will be necessary to demonstrate the unacceptable risk indicated by the rule.* *As a starting point, it is necessary to recall what this Chamber has established regarding the precautionary principle in environmental matters:* *“III.- The prevention of environmental risk. Establishing this obligation of the State at the constitutional level, it is important to appreciate how, at the level of international instruments for the protection of human rights, concrete obligations that must be respected are also established. In environmental matters, the duty of prevention that must exist in this area has been defined; the Rio Declaration, adopted at the United Nations Conference on Environment and Development, provides that:* *\"Principle 15.- In order to protect the environment, the precautionary approach shall be widely applied by States according to their capabilities. Where there are threats of serious or irreversible damage, lack of full scientific certainty shall not be used as a reason for postponing cost-effective measures to prevent environmental degradation.\"* *Prevention aims to anticipate negative effects and ensure the protection, conservation, and adequate management of resources. Consequently, the guiding principle of prevention is based on the need to take and assume all precautionary measures to avoid or contain the possible affectation of the environment or people's health. Thus, in the event that there is a risk of serious or irreversible damage—or a doubt in this regard—a precautionary measure must be adopted, and even the activity in question postponed. The foregoing is because, in environmental matters, a posteriori coercion is ineffective, since if the damage has occurred, the biologically and socially harmful consequences may be irreparable; repression may have moral significance, but it will hardly compensate for the damage caused to the environment.* *As the aforementioned international instrument indicates, as well as Article fifty of the Constitution, it is the State that is called upon to carry out this task of prevention, and this Chamber has recognized it by affirming, through judgment number 2001-6503, of July six, two thousand one, that:* *“The third paragraph of Constitutional numeral 50 clearly indicates that the State must guarantee, defend, and preserve the right of every person to a healthy and ecologically balanced environment; which implies affirming that public entities are not only obliged to enforce—on individuals and other public entities—environmental legislation, but also, first and foremost, that they must adjust their actions to the dictates of those protective normative bodies. State institutions are the first called to comply with protective environmental legislation, without there being any justification to exempt them from compliance with environmental requirements such as, for example, the environmental impact assessment (estudio de impacto ambiental) required by the Organic Law of the Environment for activities undertaken by public entities that, by their nature, may alter or destroy the environment.” (Judgment 2010-11941 of 11:21 a.m. on July 9, 2010)* *As can be inferred from the transcription, the prevalence of the precautionary principle lies in the need to avoid serious and irreparable damage to the environment, mandating the adoption of measures that anticipate such damage. That is, given the possibility that an irreversible or serious danger materializes, the State's duty to act arises, requiring for this only the existence of a reasonable doubt of risk to the environment.* *Now, contrary to what the majority defends, the precautionary principle is not limited to one stage of the administrative procedure, but rather constitutes one of the principles that must guide administrative action at all times.* *We consider that the interpretation made by the Chamber could mean the creation of a presumption in favor of the registration and against the environment and human health. In this way, the burden would be imposed on the State to prove the existence of the aforementioned risk, in order to overturn such a presumption. But even more, it is not enough to merely demonstrate the risk; the State must also prove, according to the majority, that said risk is unacceptable, which makes it even more difficult to act in favor of the environment and human health.* *These requirements could be unreasonable and disproportionate, since months or years may pass between the moment the reasonable doubt arises and the moment the existence of an unacceptable degree of risk can be demonstrated. This time lapse would enable the risk to materialize and the environment and human health to be harmed, irreversibly or seriously. Thus, there could be a contradiction between the situation of lege lata and the aims of the precautionary principle, which clearly justifies that the action be proceeded with.* *The claimant could also be correct in criticizing the reversal of the burden of proof. In this case, the registration holder possesses all the technical information related to the product and, moreover, is the subject interested in maintaining its legal use in the country, which makes it reasonable to impose on them the burden of proving its harmlessness to the environment and human health.* *We consider that all these issues must be analyzed more thoroughly by the full Chamber, granting a hearing to the Office of the Attorney General of the Republic (Procuraduría General de la República) and the competent bodies.* *Furthermore, in view of the current environmental problem and the international consensus regarding the imminence of environmental problems that threaten the entire human race (such as climate change, recognized in the Paris Agreement by 193 States), it surprises the undersigned that the majority of this Chamber advocates the non-application of the precautionary principle and, rather, defends imposing qualified requirements on the Administration when it seeks to safeguard the environment and human health.* *By virtue of the arguments presented, we dissent and order that the action proceed.”* ***4.- Regarding citizen participation.** * *In judgment No. 2021-25386 of 1:10 p.m. on November 10, 2021, we referred to citizen participation in the following terms:* *“As was recorded in the dissenting opinion to judgment No. 2017-1163 of 9:40 a.m. on January 27, 2017, we consider that from Article 9 of the Political Constitution, it is extracted that citizen participation, beyond a general principle, has been instituted as a true fundamental right in light of the conventional framework that accompanies and integrates our regime of fundamental rights.* *Precisely, in judgment No. 2013-017305 of 11:32 a.m. on December 20, 2013, the Constitutional Chamber considers that the right to citizen participation in decision-making has become one of the fundamental pillars upon which the democratic system rests. In our country, the constitutional legislator enshrined this right in Article 9 of the Political Constitution by providing that the Government of the Republic be popular, representative, participatory, alternating, and responsible (emphasis not in original), according to the reform promoted by Law No. 8364 of July 1, 2003, published in La Gaceta No. 146 of July 31, 2003. This mandate of the Fundamental Law, particularly the quality of “participatory,” has guided a subsequent normative constitutional and infra-constitutional development. Thus, a series of mechanisms have been established that seek to ensure the right to participatory government can be applied effectively and efficiently, so that it does not remain merely a right on paper; examples of the foregoing are the referendum for the approval or repeal of laws and partial reforms to the Constitution, or the popular initiative in the formation of laws (see, among others, judgment number 2005-05649 of 2:39 p.m. on May 11, 2005).* *The right to participatory government not only embodies a recognition of the highest positive-legal rank to the function of political control by the inhabitants of the Republic, but also signifies a revaluation of their role in the processes of formulation, application, and control of public policy. By the will of the constituent legislator, which this Chamber neither should nor can ignore, the right to participatory government stands as a fundamental pillar of our democratic regime (a matter erroneously ignored by the minority vote, which downgrades citizen participation from a right to a general principle, in clear opposition to the jurisprudential line of this Chamber, as demonstrated below), which is consistent with a political system based on tolerance, pluralism, and respect for freedom.* *As we indicated supra, this categorization of participatory government or citizen participation as a right is explained through the conventional support contained in various international human rights instruments.* *Verbigratia, Article 21 of the Universal Declaration of Human Rights of 1948 provides that “everyone has the right to take part in the government of his country, directly or through freely chosen representatives” (emphasis not in original).* *Consistent with the above, Article 25 of the International Covenant on Civil and Political Rights expressly recognizes the right of citizens: “(…) to take part in the conduct of public affairs, directly or through freely chosen representatives.”* *In the same vein, the Inter-American Democratic Charter states in its Article 5 that: “Representative democracy is strengthened and deepened by permanent, ethical, and responsible participation of the citizenry within a legal framework consistent with the respective constitutional order.”* *More vehemently, Article 6 of this Charter provides that: “The participation of the citizenry in decisions relating to their own development is a right and a responsibility. It is also a necessary condition for the full and effective exercise of democracy. Promoting and fostering various forms of participation strengthens democracy.” (Emphasis not in original).* *The United Nations Human Rights Council also recognized citizen participation as fundamental for the protection of the environment:* *“Recognizing also that the exercise of human rights, including the freedom to seek, receive and impart information and to participate effectively in the direction of government and public affairs and the right to an effective remedy, is fundamental for the protection of a clean, healthy, safe and sustainable environment,” (Human Rights Council, 46th session, A/HRC/RES/46/7 of March 23, 2021).* *It is also important to highlight that, recently, the United Nations Human Rights Council, in resolution A/HRC/RES/48/13 of October 8, 2021, has come to grant the status of a human right to effective participation in environmental matters. In this regard, it stated:* *“Recognizing that the exercise of human rights, including the rights to seek, receive and impart information and to participate effectively in the direction of government and public affairs and in decision-making relating to the environment, as well as the right to an effective remedy, is fundamental for the protection of a clean, healthy and sustainable environment.” (Emphasis not in original).* *For its part, in Advisory Opinion OC-23/17 of November 15, 2017, the Inter-American Court of Human Rights highlighted that:* *“226. Public participation represents one of the fundamental pillars of instrumental or procedural rights, given that it is through participation that individuals exercise democratic control over state management and can thus question, investigate, and consider the fulfillment of public functions. In that sense, participation allows individuals to be part of the decision-making process and for their opinions to be heard. In particular, public participation facilitates that communities demand accountability from public authorities for decision-making and, at the same time, improves the efficiency and credibility of governmental processes. As has been mentioned on previous occasions, public participation requires the application of the principles of publicity and transparency and, above all, must be supported by access to information that allows social control through effective and responsible participation” (the emphasis was added).* *A position that had also been adopted in the judgment of September 19, 2006, concerning the case “Claude Reyes et al. vs. Chile,” in which it was established:* *“86. In this regard, the State’s actions must be governed by the principles of publicity and transparency in public administration, which makes it possible for persons under its jurisdiction to exercise democratic control over state management, so that they can question, investigate, and consider whether there is adequate compliance with public functions. Access to information under the control of the State, which is of public interest, can permit participation in public management through the social control that can be exercised with such access. 87. Democratic control, on the part of society through public opinion, fosters the transparency of state activities and promotes the responsibility of officials for their public management. Therefore, for persons to be able to exercise democratic control, it is essential that the State guarantee access to information of public interest under its control. By allowing the exercise of that democratic control, greater participation of individuals in the interests of society is fostered.” (The emphasis was added).* *Thus, this conventional recognition of citizen participation hermeneutically affects its juridical nature, since it transforms it from a constitutional principle into a true collective fundamental right.* *In this way, citizen participation represents an essential aspect of the democratic and republican model of this century, in which citizen control, transparency, and accountability stand out as expressive elements of this type of political regime, which in turn confers much greater legitimacy to political decision-making, a key matter when it comes to governability.* Thus, within the framework of this type of regime </span><span style=\"font-family:'Times New Roman'; font-style:italic\">‑</span><span style=\"font-family:'Times New Roman'; font-style:italic\">that is, with active and full citizen participation</span><span style=\"font-family:'Times New Roman'; font-style:italic\">‑</span><span style=\"font-family:'Times New Roman'; font-style:italic\">, participatory government has a greater impact, favoring decision-making through more open and transparent means.</span></p><p style=\"margin-top:14pt; margin-left:35.4pt; margin-bottom:14pt; text-indent:35.4pt; text-align:justify; line-height:150%; font-size:14pt\"><span style=\"font-family:'Times New Roman'; font-style:italic\">Precisely, one of the mechanisms designed to comply with the provisions of constitutional article 9 is the public hearing, through which interested persons can assert their rights or express their opinion, actively participating in matters of national or local relevance, and bringing to the attention of the Administration all those anomalies or disagreements in relation to a project to be developed.</span></p><p style=\"margin-top:14pt; margin-left:35.4pt; margin-bottom:14pt; text-indent:35.4pt; text-align:justify; line-height:150%; font-size:14pt\"><span style=\"font-family:'Times New Roman'; font-style:italic\">Thus, the public hearing is a typical instrument of a republican democracy, through which citizen participation in the public decision-making process is fostered. By its very nature, the hearing must be conducted in such a way as to guarantee the greatest possible participation of persons who may be affected; hence, any action or omission that hinders the foregoing constitutes an open violation of the constitutional right to citizen participation (see, among others, judgment number 2009-018223 of 12:34 hours on November 27, 2009).</span></p><p style=\"margin-top:14pt; margin-left:35.4pt; margin-bottom:14pt; text-indent:35.4pt; text-align:justify; line-height:150%; font-size:14pt\"><span style=\"font-family:'Times New Roman'; font-style:italic\">Regarding the participatory nature of the public hearing, as indicated, article 9 of the Political Constitution itself requires it, because the qualification “participatory” established therein implies, among other aspects, that the Government must be an articulator of what is defined by popular deliberation, when this is mandatory, while in the formulation of public policy, within the possibilities that the current positive legal framework presents, it is obliged to listen to the opinion of affected individuals or groups, whether it is binding or not.</span></p><p style=\"margin-top:14pt; margin-left:35.4pt; margin-bottom:14pt; text-indent:35.4pt; text-align:justify; line-height:150%; font-size:14pt\"><span style=\"font-family:'Times New Roman'; font-style:italic\">In other words, in the current republican democracy, citizens enjoy, by constitutional mandate, no longer only the right to vote to exercise their right to participatory government, but a number of instruments of diverse nature to contribute to governmental decision-making and political control, which allows them to exert direct influence on major public decisions.</span></p><p style=\"margin-top:14pt; margin-left:35.4pt; margin-bottom:14pt; text-indent:35.4pt; text-align:justify; line-height:150%; font-size:14pt\"><span style=\"font-family:'Times New Roman'; font-style:italic\">Within this context, it is worth highlighting that this Court, in judgment No. 2018004117 of 9:15 hours on March 13, 2018, developed the concept of public consultation in environmental matters, emphasizing that this mechanism is a pillar in decision-making related to the environment. Likewise, as soft law, it invoked a particularly relevant instrument regarding access to environmental information and citizen participation: the “Convention on Access to Information, Public Participation in Decision-making and Access to Justice in Environmental Matters,” better known as the “Aarhus Convention.” In this regard, the aforementioned ruling stated:</span></p><p style=\"margin-top:14pt; margin-left:35.4pt; margin-bottom:14pt; text-indent:35.4pt; text-align:justify; line-height:150%; font-size:14pt\"><span style=\"font-family:'Times New Roman'; font-style:italic\">“The Aarhus Convention, for its part, in article 6.2.3.4 provides:</span></p><p style=\"margin-top:14pt; margin-left:35.4pt; margin-bottom:14pt; text-indent:35.4pt; text-align:justify; line-height:150%; font-size:14pt\"><span style=\"font-family:'Times New Roman'; font-style:italic\">“2. The public concerned shall be informed, whether by public notice or individually as appropriate, early in an environmental decision-making procedure, and in an adequate, timely and effective manner, inter alia, of:</span></p><p style=\"margin-top:14pt; margin-left:35.4pt; margin-bottom:14pt; text-indent:35.4pt; text-align:justify; line-height:150%; font-size:14pt\"><span style=\"font-family:'Times New Roman'; font-style:italic\">a) The proposed activity and the application on which a decision will be taken;</span></p><p style=\"margin-top:14pt; margin-left:35.4pt; margin-bottom:14pt; text-indent:35.4pt; text-align:justify; line-height:150%; font-size:14pt\"><span style=\"font-family:'Times New Roman'; font-style:italic\">b) The nature of possible decisions or the draft decision;</span></p><p style=\"margin-top:14pt; margin-left:35.4pt; margin-bottom:14pt; text-indent:35.4pt; text-align:justify; line-height:150%; font-size:14pt\"><span style=\"font-family:'Times New Roman'; font-style:italic\">c) The public authority responsible for making the decision;</span></p><p style=\"margin-top:14pt; margin-left:35.4pt; margin-bottom:14pt; text-indent:35.4pt; text-align:justify; line-height:150%; font-size:14pt\"><span style=\"font-family:'Times New Roman'; font-style:italic\">d) The envisaged procedure, including, as and when this information can be provided:</span></p><p style=\"margin-top:14pt; margin-left:35.4pt; margin-bottom:14pt; text-indent:35.4pt; text-align:justify; line-height:150%; font-size:14pt\"><span style=\"font-family:'Times New Roman'; font-style:italic\">i) The commencement of the procedure;</span></p><p style=\"margin-top:14pt; margin-left:35.4pt; margin-bottom:14pt; text-indent:35.4pt; text-align:justify; line-height:150%; font-size:14pt\"><span style=\"font-family:'Times New Roman'; font-style:italic\">ii) The opportunities for the public to participate;</span></p><p style=\"margin-top:14pt; margin-left:35.4pt; margin-bottom:14pt; text-indent:35.4pt; text-align:justify; line-height:150%; font-size:14pt\"><span style=\"font-family:'Times New Roman'; font-style:italic\">iii) The time and venue of any envisaged public hearing;</span></p><p style=\"margin-top:14pt; margin-left:35.4pt; margin-bottom:14pt; text-indent:35.4pt; text-align:justify; line-height:150%; font-size:14pt\"><span style=\"font-family:'Times New Roman'; font-style:italic\">iv) An indication of the public authority from which relevant information can be obtained and where the relevant information has been deposited for examination by the public;</span></p><p style=\"margin-top:14pt; margin-left:35.4pt; margin-bottom:14pt; text-indent:35.4pt; text-align:justify; line-height:150%; font-size:14pt\"><span style=\"font-family:'Times New Roman'; font-style:italic\">v) An indication of the relevant public authority or any other official body to which comments or questions can be submitted and of the time schedule for transmittal of comments or questions; and</span></p><p style=\"margin-top:14pt; margin-left:35.4pt; margin-bottom:14pt; text-indent:35.4pt; text-align:justify; line-height:150%; font-size:14pt\"><span style=\"font-family:'Times New Roman'; font-style:italic\">vi) An indication of what environmental information relevant to the proposed activity is available; and</span></p><p style=\"margin-top:14pt; margin-left:35.4pt; margin-bottom:14pt; text-indent:35.4pt; text-align:justify; line-height:150%; font-size:14pt\"><span style=\"font-family:'Times New Roman'; font-style:italic\">e) The fact that the activity is subject to a national or transboundary environmental impact assessment procedure.</span></p><p style=\"margin-top:14pt; margin-left:35.4pt; margin-bottom:14pt; text-indent:35.4pt; text-align:justify; line-height:150%; font-size:14pt\"><span style=\"font-family:'Times New Roman'; font-style:italic\">3. The public participation procedures shall include reasonable time-frames for the different phases, allowing sufficient time for informing the public in accordance with paragraph 2 above and for the public to prepare and participate effectively during the environmental decision-making.</span></p><p style=\"margin-top:14pt; margin-left:35.4pt; margin-bottom:14pt; text-indent:35.4pt; text-align:justify; line-height:150%; font-size:14pt\"><span style=\"font-family:'Times New Roman'; font-style:italic\">4. Each Party shall provide for early public participation, when all options are open and effective public participation can take place.”</span></p><p style=\"margin-top:14pt; margin-left:35.4pt; margin-bottom:14pt; text-indent:35.4pt; text-align:justify; line-height:150%; font-size:14pt\"><span style=\"font-family:'Times New Roman'; font-style:italic\">In accordance with the foregoing, consultation must be fostered transparently and with the greatest possible information. This generates better management of natural resources, contributes to transparency and the proper management of public funds. Let us remember that the environmental issue is a matter for all members of society, not just the government, so it is also the responsibility of every citizen to ensure the conservation of the environment and to strive for sustainable development. That is why it must comprehensively encompass the different sectors of the population (…)”. (The highlighting was added).</span></p><p style=\"margin-top:14pt; margin-left:35.4pt; margin-bottom:14pt; text-indent:35.4pt; text-align:justify; line-height:150%; font-size:14pt\"><span style=\"font-family:'Times New Roman'; font-style:italic\">In addition, in the aforementioned ruling, the Chamber stressed that the citizen hearing, being a manifestation of the democratic principle, should not become a simple formality that simply and plainly must be scheduled, although it should also not be instrumentalized as a mere obstacle to the issuance of an administrative decision.</span></p><p style=\"margin-top:14pt; margin-left:35.4pt; margin-bottom:14pt; text-indent:35.4pt; text-align:justify; line-height:150%; font-size:14pt\"><span style=\"font-family:'Times New Roman'; font-style:italic\">Related to the above, this Chamber has repeatedly pointed out that the Constitution is characterized by its supremacy and its direct and immediate effectiveness, by virtue of which the rights and guarantees it confers are directly enforceable and binding on all Public Powers. Thus, in judgment No. 1992-3194 of 16:00 hours on October 27, 1992, it was specified:</span></p><p style=\"margin-top:14pt; margin-left:35.4pt; margin-bottom:14pt; text-indent:35.4pt; text-align:justify; line-height:150%; font-size:14pt\"><span style=\"font-family:'Times New Roman'; font-style:italic\">“(…) The Political Constitution, in its unanimous contemporary conception, is not only ‘supreme’ as a criterion of validity of itself and of the rest of the legal system, but also a set of legally binding fundamental norms and principles, therefore, enforceable by themselves, against all public authorities, and against private individuals themselves, without the need for other norms or acts that develop them or make them applicable —except in qualified exceptional cases, in which without them its application is impossible—; with the consequence that the authorities, both administrative and jurisdictional, have the attribution-duty to directly apply the Law of the Constitution in its full sense, even in the absence of a lower-ranking norm or disapplying those that oppose it.”</span></p><p style=\"margin-top:14pt; margin-left:35.4pt; margin-bottom:14pt; text-indent:35.4pt; text-align:justify; line-height:150%; font-size:14pt\"><span style=\"font-family:'Times New Roman'; font-style:italic\">For its part, in judgment No. 1995-1185 of 14:33 hours on March 2, 1995, this Court confirmed:</span></p><p style=\"margin-top:14pt; margin-left:35.4pt; margin-bottom:14pt; text-indent:35.4pt; text-align:justify; line-height:150%; font-size:14pt\"><span style=\"font-family:'Times New Roman'; font-style:italic\">“If the Political Constitution has a supreme normative character, it must effectively conform and condition the validity and effectiveness of all inferior or subordinate norms, and serves as a parameter to legitimize or not the actions of any public authority and even of private subjects.... The principle of supremacy of the Constitution, in the Costa Rican case, is not only expressly enshrined in Article 10, but also very clearly complemented with respect to the body in charge of maintaining or preserving it, according to what we will analyze below. What we have expressed so far revolves around the fact that the Constitution has a direct effectiveness and binds without the need for intermediation by any other norm. And, it is for this reason that every authority, in general, has the capacity and power to apply, develop and expand the fundamental rights contained in the Political Constitution. If this were not the case, all the argumentation about the hierarchy of constitutional norms, principles and values, would fall converted into an unsustainable fantasy. It would be mere science fiction, an entelechy, in which two legal worlds simultaneously exist located on different planes and without communication between them.”</span></p><p style=\"margin-top:14pt; margin-left:35.4pt; margin-bottom:14pt; text-indent:35.4pt; text-align:justify; line-height:150%; font-size:14pt\"><span style=\"font-family:'Times New Roman'; font-style:italic\">In conclusion, citizen participation constitutes a constitutional and conventional right, which stands as a quality of the republican democratic system. In this regard, the rights enshrined in the Fundamental Law, to varying degrees depending on whether their content is more or less programmatic, have direct effectiveness and bind without the need for any norm. Even their effectiveness through infra-constitutional normative development and its application is not immune to jurisdictional control of constitutionality, when regulations, actions or omissions are noticed that represent an injury to the hard core (Kernbereich) of that constitutional good.”</span></p><p style=\"margin-top:14pt; margin-bottom:14pt; text-indent:35.4pt; text-align:justify; line-height:150%; font-size:14pt\"><span style=\"font-family:'Times New Roman'; font-style:italic\">In the sub lite case, we consider that the challenged decree injures the right to citizen participation in matters of utmost importance for the population, such as the environment and public health. The relevance of citizen participation in this matter is recognized in the already cited “International Code of Conduct on the Distribution and Use of Pesticides. Guidelines for the Registration of Pesticides,” whose point 3 (The principles of pesticide registration) states:</span></p><p style=\"margin-top:14pt; margin-left:35.4pt; margin-bottom:14pt; text-indent:35.4pt; text-align:justify; line-height:150%; font-size:14pt\"><span style=\"font-family:'Times New Roman'; font-style:italic\">“Governments should facilitate the exchange of information between responsible authorities through national institutions, international, regional and sub-regional organizations as well as public sector groups. They should develop legislation and regulations to permit the exchange of information with the public on the risks and benefits of pesticides and also to facilitate </span><span style=\"font-family:'Times New Roman'; font-style:italic; text-decoration:underline\">public participation</span><span style=\"font-family:'Times New Roman'; font-style:italic\"> in the management of the country’s pesticides.” (The underlining is added).</span><br><span style=\"font-family:'Times New Roman'; font-style:italic\">Citizen participation is also included in its point 10 (Coordination and collaboration):</span></p><p style=\"margin-top:14pt; margin-left:35.4pt; margin-bottom:14pt; text-indent:35.4pt; text-align:justify; line-height:150%; font-size:14pt\"><span style=\"font-family:'Times New Roman'; font-style:italic\">“10.1.3 Regulated community </span></p><p style=\"margin-top:14pt; margin-left:35.4pt; margin-bottom:14pt; text-indent:35.4pt; text-align:justify; line-height:150%; font-size:14pt\"><span style=\"font-family:'Times New Roman'; font-style:italic\">There should be regular dialogues between the responsible authority and the regulated community, including the pesticide industry, pesticide vendors, professional pest control operators, pesticide advertising agencies and </span><span style=\"font-family:'Times New Roman'; font-style:italic; text-decoration:underline\">the general public</span><span style=\"font-family:'Times New Roman'; font-style:italic\">, to receive feedback and suggestions on the implementation and enforcement of pesticide registration in the country. The responsible authority should encourage the pesticide industry to develop low-risk pesticide products as well as product stewardship activities. </span></p><p style=\"margin-top:14pt; margin-left:35.4pt; margin-bottom:14pt; text-indent:35.4pt; text-align:justify; line-height:150%; font-size:14pt\"><span style=\"font-family:'Times New Roman'; font-style:italic\">10.1.4 Civil society </span></p><p style=\"margin-top:14pt; margin-bottom:14pt; text-indent:35.4pt; text-align:justify; line-height:150%; font-size:14pt\"><span style=\"font-family:'Times New Roman'; font-style:italic\">The responsible authority may have a </span><span style=\"font-family:'Times New Roman'; font-style:italic; text-decoration:underline\">frequent dialogue with representatives of civil society</span><span style=\"font-family:'Times New Roman'; font-style:italic\"> to address issues related to pesticide registration in the country. Civil society groups can in particular be important in providing feedback on the use of pesticides, and on the actual and potential problems that may occur.” (The underlining is added).</span><span style=\"font-family:'Times New Roman'\">”</span></p><p style=\"margin-top:0pt; margin-bottom:0pt; text-align:justify; line-height:150%; font-size:14pt\"><span style=\"width:36pt; display:inline-block\">&nbsp;</span><span style=\"font-family:'Times New Roman'\">Additionally, regarding the specific case, we establish the following defects that merit declaring the unconstitutionality of the decree.</span></p><p style=\"margin-top:0pt; margin-bottom:0pt; text-align:justify; line-height:150%; font-size:14pt\"><span style=\"width:36pt; display:inline-block\">&nbsp;</span><span style=\"font-family:'Times New Roman'\">Regarding the reduction of requirements for the approval of the valida, we determine that Article 1 does not require acute toxicity and ecotoxicity studies, as Decree 33495 did. Furthermore, Article 1.1 eliminated the requirement for the manufacturer update, the registration certificate issued by the authority of the country of origin, and the endorsement of a chemist for the qualitative-quantitative composition certificate. Article 1.2 eliminated the registration certificate issued by the authority of the country of origin. </span></p><p style=\"margin-top:0pt; margin-bottom:0pt; text-align:justify; line-height:150%; font-size:14pt\"><span style=\"width:36pt; display:inline-block\">&nbsp;</span><span style=\"font-family:'Times New Roman'\">Likewise, regarding the use of referenced information, we adopt the clarifications of the Procuraduría General de la República: </span></p><p style=\"margin-top:0pt; margin-bottom:0pt; text-indent:35.4pt; text-align:justify; line-height:150%; font-size:14pt\"><span style=\"font-family:'Times New Roman'\">“…</span><span style=\"font-family:'Times New Roman'; font-style:italic\">although the Procuraduría is not a technical body in the matter, it can be indicated that even though the challenged Decree modifies articles 1.2.b and 6 of Decree 39995 that allowed registering products through referenced information, it maintains that possibility, because in article 1.2.c it allows the use of international specifications to prove that the technical material intended to be updated does not have relevant impurities, indicating in the fifth whereas clause that international specifications and standards are a technical and scientific reference to determine that technical grade active ingredients do not contain relevant impurities at levels higher than the international standards or specifications, and that only those relevant impurities have toxicological or ecotoxicological relevance that can cause an effect on health or the environment.</span></p><p style=\"margin-top:0pt; margin-bottom:0pt; text-indent:35.4pt; text-align:justify; line-height:150%; font-size:14pt\"><span style=\"font-family:'Times New Roman'; font-style:italic\">In that same sense,</span><span style=\"font-family:'Times New Roman'\"> </span><span style=\"font-family:'Times New Roman'; font-style:italic\">in Article 3° it provides that formulated pesticides that do not have an associated technical grade active ingredient registration will be granted that registration directly when the manufacturer of that active ingredient has been updated; Article 6° provides that once the requirements are met, the registration will be granted for ten years and that, during that period, the SFE will verify that the already approved registrations of technical grade active ingredients have chemical equivalence with the reference profile of that active ingredient and that, in the absence of that profile, it must be verified that they do not contain relevant impurities; and Article 11 endorses the homologation of labels and leaflets with those of other already registered products that have the same active ingredient and equal concentration, without contemplating the effects that the other components of the product or the form or method of preparation could have.</span></p><p style=\"margin-top:0pt; margin-bottom:0pt; text-indent:35.4pt; text-align:justify; line-height:150%; font-size:14pt\"><span style=\"font-family:'Times New Roman'; font-style:italic\">In the challenged norm, it is not established how the information will be verifiable, how to determine which international specification can be used, the way to determine the equivalence of products, nor whether the reference profile to be used must be a registration that has complete information, and therefore, that covers acute toxicity, ecotoxicity, chronic toxicology, ecotoxicological studies and other studies on the abiotic environment as required by Article 5° of the Law for the Import and Quality Control of Agrochemicals and the FAO and WHO Manual on Development and Use of FAO and WHO Specifications for Pesticides.</span></p><p style=\"margin-top:0pt; margin-bottom:0pt; text-indent:35.4pt; text-align:justify; line-height:150%; font-size:14pt\"><span style=\"font-family:'Times New Roman'; font-style:italic\">Hence, as indicated in the previous report, by not precisely establishing the rules to which the competent authority must adhere to verify the information, it is possible that the updating of registrations with referenced information that does not meet the indicated requirements is permitted, and, therefore, this would imply the updating of product registrations without a prior evaluation of the environmental and health risks of their application.</span><span style=\"font-family:'Times New Roman'\">”</span></p><p style=\"margin-top:0pt; margin-bottom:0pt; text-indent:35.4pt; text-align:justify; line-height:150%; font-size:14pt\"><span style=\"font-family:'Times New Roman'\">By virtue of the foregoing, we determine that the challenged decree contravenes the block of constitutionality and injures the right to a healthy and ecologically balanced environment. Therefore, we dissent and declare the action granted.</span></p><p style=\"margin-top:0pt; margin-bottom:0pt; text-align:center; line-height:150%; font-size:14pt\"><span style=\"font-family:'Times New Roman'; font-weight:bold; -aw-import:ignore\">&nbsp;</span></p><p style=\"margin-top:0pt; margin-bottom:0pt; text-align:center; line-height:150%; font-size:14pt\"><span style=\"font-family:'Times New Roman'; font-weight:bold; -aw-import:ignore\">&nbsp;</span></p><p style=\"margin-top:0pt; margin-bottom:0pt; text-align:center; line-height:150%; font-size:14pt\"><span style=\"font-family:'Times New Roman'; font-weight:bold\">Fernando Cruz C.</span><span style=\"width:34.73pt; display:inline-block\">&nbsp;</span><span style=\"width:36pt; display:inline-block\">&nbsp;</span><span style=\"width:36pt; display:inline-block\">&nbsp;</span><span style=\"width:36pt; display:inline-block\">&nbsp;</span><span style=\"font-family:'Times New Roman'; font-weight:bold\"> Paul Rueda L.</span></p><p style=\"margin-top:0pt; margin-bottom:0pt\"><span style=\"font-family:'Times New Roman'; -aw-import:ignore\">&nbsp;</span></p><p style=\"margin-top:0pt; margin-bottom:0pt\"><span style=\"font-family:'Times New Roman'; -aw-import:ignore\">&nbsp;</span></p><p style=\"margin-top:0pt; margin-bottom:0pt\"><span style=\"font-family:'Times New Roman'; -aw-import:ignore\">&nbsp;</span></p><p style=\"margin-top:0pt; margin-bottom:0pt; text-align:justify; line-height:150%; font-size:14pt\"><span style=\"font-family:'Times New Roman'; font-weight:bold\">Exp. 19-005920-0007-CO</span></p><p style=\"margin-top:0pt; margin-bottom:0pt; text-align:justify; line-height:150%; font-size:14pt\"><span style=\"font-family:'Times New Roman'; font-weight:bold\">Res. nro. 2023002389</span></p><p style=\"margin-top:0pt; margin-right:2.45pt; margin-bottom:0pt; text-indent:35.4pt; text-align:justify; line-height:150%; font-size:14pt\"><span style=\"font-family:'Times New Roman'; font-weight:bold\">Note from Magistrate Rueda Leal. </span><span style=\"font-family:'Times New Roman'\">As I have expressed in other cases, I consider that a quality of a diffuse interest consists precisely in that its affectation is general —that is, it affects an entire population or broad sectors of it— within a context where it is not necessary for the affected subjects to know each other (they could even lack any nexus or legal relationships among them), but the presence of the same situation of damage or danger to a constitutional good is required, which, equally and without any individualization, encompasses and agglomerates an entire society in the abstract. Its defense aims to satisfy a need of society as such, therefore, it transcends that of an individual human being considered individually or collectively. In judgment No. 2019-17397 of 12:54 hours on September 11, 2019, this Court reiterated the following: </span></p><p style=\"margin:14pt 2.45pt 14pt 42.55pt; text-align:justify; line-height:150%; font-size:14pt\"><span style=\"font-style:italic\">“(…) </span><span style=\"font-family:'Times New Roman'; font-style:italic\">Secondly, the possibility of acting in defense of ‘diffuse interests’ is foreseen; this concept, whose content has been gradually delineated by the Chamber, could be summarized in the terms used in judgment of this court number 3750-93, of fifteen hours on July thirty, nineteen ninety-three) ‘… Diffuse interests, although difficult to define and more difficult to identify, cannot be in our law —as this Chamber has already said— merely collective interests; nor so diffuse that their ownership is confused with that of the national community as a whole, nor so concrete that identified or easily identifiable determined persons, or personalized groups, are identified before them, whose legitimacy would derive, not from diffuse interests, but from corporate interests that concern a community as a whole. It is therefore a matter of individual interests, but at the same time, diluted in more or less extensive and amorphous sets of people who share an interest and, therefore, receive a harm, actual or potential, more or less the same for all, so it is rightly said that it is a matter of equal interests of the groups that are in certain circumstances and, at the same time, of each one of them.

That is, diffuse interests partake of a dual nature, since they are simultaneously collective—being common to a generality—and individual, and therefore can be claimed in that capacity.</span></p><p style="margin:14pt 2.45pt 14pt 42.55pt; text-align:justify; line-height:150%; font-size:14pt"><span style="font-family:'Times New Roman'; font-style:italic">In summary, diffuse interests are those whose ownership belongs to groups of persons not formally organized, but united around a particular social need, a physical characteristic, their ethnic origin, a particular personal or ideological orientation, the consumption of a certain product, etc. The interest, in these cases, is blurred, diluted (diffuse) among an unidentified plurality of subjects. In these cases, of course, the challenge that a member of one of these sectors could bring under paragraph 2 of Article 75 must necessarily refer to provisions that affect them as such. This Chamber has listed various rights to which it has given the label of "diffuse," such as the environment, cultural heritage, defense of the country's territorial integrity, and sound management of public spending, among others. In this regard, two clarifications must be made: on one hand, the aforementioned goods transcend the sphere traditionally recognized for diffuse interests, since they refer in principle to aspects that affect the national collectivity and not particular groups within it; environmental damage does not affect only the neighbors of a region or the consumers of a product, but rather injures or gravely endangers the natural heritage of the entire country and even of Humanity; likewise, the defense of the sound management of public funds authorized in the National Budget is an interest of all the inhabitants of Costa Rica, not just any one group of them. On the other hand, the enumeration made by the Constitutional Chamber is nothing more than a simple description inherent to its obligation </span><span style="font-style:italic">–</span><span style="font-family:'Times New Roman'; font-style:italic">as a jurisdictional body—to limit itself to hearing the cases brought before it, without it being understood in any way that only those rights that the Chamber has expressly recognized as such can be considered diffuse rights; the foregoing would imply an undesirable upheaval in the scope of the Rule of Law (Estado de Derecho), and of its correlative "State of Rights" (Estado de derechos), which </span><span style="font-style:italic">–</span><span style="font-family:'Times New Roman'; font-style:italic">as in the case of the Costa Rican model—starts from the premise that what must be express are the limits to freedoms, since these underlie the human condition itself and therefore do not require official recognition. Finally, when paragraph 2 of Article 75 of the Constitutional Jurisdiction Law (Ley de la Jurisdicción Constitucional) speaks of interests "that concern the collectivity as a whole," it refers to the legal goods explained in the preceding lines, that is, those whose ownership rests with the very holders of sovereignty, with each of the inhabitants of the Republic.</span></p><p style="margin:14pt 45pt 14pt 42.55pt; text-align:justify; line-height:150%; font-size:14pt"><span style="font-family:'Times New Roman'; font-style:italic">It is therefore not a matter of any person being able to appeal to the Constitutional Chamber in protection of any interests whatsoever (popular action (acción popular)), but rather that every individual may act in defense of those goods that affect the entire national collectivity, without any attempt at an exhaustive enumeration being valid in this field either” (see judgment No. 2007- 01145).</span><span style="font-style:italic">”</span></p><p style="margin-top:0pt; margin-bottom:0pt; text-indent:35.4pt; text-align:justify; line-height:150%; font-size:14pt"><span style="font-family:'Times New Roman'">In line with what has been stated and sustained by this Court in its jurisprudence, it thus concerns </span><span style="font-family:'Times New Roman'; font-weight:bold">individual interests</span><span style="font-family:'Times New Roman'">, but at the same time, </span><span style="font-family:'Times New Roman'; font-weight:bold">diluted in more or less extensive and amorphous groups of people who share an interest </span><span style="font-family:'Times New Roman'">and, therefore, suffer a harm, actual or potential, more or less equal for all, which is why it is rightly said that these are equal interests of the groups that find themselves in certain circumstances and, at the same time, of each one of them. It is precisely for this reason that, starting from judgment No. 2021-2185 of 12:51 hours on February 3, 2021, I consider, unlike the Majority of this Court, that some of these interests can be embodied in a specific particular case, without thereby losing their condition as a diffuse interest, as occurs with environmental protection, whose impact affects a single person and everyone in general; and such affectation can be individualized in a particular situation, such as, for example, the construction of a factory in a certain neighboring sector, without the respective environmental studies, whose negative effects impact the planet's ozone layer. Undoubtedly, the result of a claim or </span><span style="font-family:'Times New Roman'">proceeding that a neighbor might bring against that factory will not only affect their own interests, but also those of the rest of the collectivity. Therefore, it constitutes a diffuse interest; and yet, it is also the object of a particular, individualized situation</span><span style="font-family:'Times New Roman'">. That said, this does not mean, in any way, that in every situation invoked one can allege the existence of a diffuse interest, even if it can be the object of a particular situation. Let us remember that for an interest to be considered “diffuse,” it must not only affect a collectivity, but must also be blurred, spread throughout that collectivity. If it does not produce such an effect, it cannot be considered a diffuse interest. In this case, the diffuse interest alleged by the plaintiffs is environmental protection. For this reason and based on the clarifications just made, I hear the case on the merits.</span></p><p style="margin-top:0pt; margin-bottom:0pt; text-align:justify; line-height:150%; font-size:14pt"><span style="font-family:'Times New Roman'; -aw-import:ignore"> </span></p><p style="margin-top:0pt; margin-bottom:0pt; text-align:justify; line-height:150%; font-size:14pt"><span style="font-family:'Times New Roman'; -aw-import:ignore"> </span></p><p style="margin-top:0pt; margin-bottom:0pt; text-align:justify; line-height:150%; font-size:14pt"><span style="font-family:'Times New Roman'; -aw-import:ignore"> </span></p><p style="margin-top:0pt; margin-bottom:0pt; text-align:center; line-height:150%; font-size:14pt"><span style="font-family:'Times New Roman'; font-weight:bold">Paul Rueda L.</span></p><p style="margin-top:0pt; margin-bottom:0pt; font-size:14pt"><span style="font-family:'Times New Roman'; font-weight:bold; -aw-import:ignore"> </span></p><p style="margin-top:0pt; margin-bottom:0pt; font-size:14pt"><span style="font-family:'Times New Roman'; font-weight:bold; -aw-import:ignore"> </span></p><p style="margin-top:0pt; margin-bottom:0pt; font-size:14pt"><span style="font-family:'Times New Roman'; font-weight:bold; -aw-import:ignore"> </span></p><p style="margin-top:0pt; margin-bottom:0pt; text-align:justify; line-height:21pt"><span style="font-weight:bold">Exp: 19-005920-0007-CO</span></p><p style="margin-top:0pt; margin-bottom:0pt; text-align:justify; line-height:21pt"><span style="font-weight:bold">Res. N° 2023-002389</span></p><p style="margin-top:0pt; margin-bottom:0pt; text-align:justify; line-height:21pt"><span style="font-weight:bold; -aw-import:ignore"> </span></p><p style="margin-top:0pt; margin-bottom:0pt; text-align:justify; line-height:150%"><span style="font-weight:bold">NOTE BY MAGISTRATE CRUZ CASTRO.-</span><span> The importance of protecting the right to the environment, to health, and to food safety (seguridad alimentaria), and in application of the constitutional environmental principles of progressivity and non-regression, precautionary principle (principio precautorio), preventive principle (principio preventivo), in dubio pro natura principle, and principle of objectification in the regulation of pesticides (principio de objetivación en materia de regulación de plaguicidas)</span><span style="font-weight:bold; text-decoration:underline">.</span></p><p style="margin-top:0pt; margin-bottom:0pt; text-align:justify; line-height:150%"><span style="-aw-import:ignore"> </span></p><p style="margin-top:0pt; margin-bottom:0pt; text-align:justify; line-height:150%"><span>As I have considered in other cases where the issue of pesticides has come before this Chamber for discussion, it is relevant to start from the jurisprudential background of judgment No. 2011-016937 of 14:36 hours on December 07, 2011:</span><span> (</span><a href="https://nexuspj.poder-judicial.go.cr/document/sen-1-0007-532977" style="text-decoration:none"><span style="text-decoration:underline; color:#0000ff">https://nexuspj.poder-judicial.go.cr/document/sen-1-0007-532977</span></a><span>). Here the Chamber outlined the constitutional framework under which a regulation for the registration, use and control of pesticides must be analyzed, when in the unconstitutionality action (acción de inconstitucionalidad) filed against Executive Decree (Decreto Ejecutivo) number 33495-MAG-S-MINAE-MEIC of October 31, 2006, the following was indicated:</span></p><p style="margin-top:0pt; margin-bottom:0pt; text-align:justify; line-height:150%"><span style="-aw-import:ignore"> </span></p><p style="margin-top:0pt; margin-left:64.35pt; margin-bottom:0pt; text-indent:28.35pt; text-align:justify; background-color:#ffffff"><span style="font-weight:bold">VI.- FOOD SAFETY (SEGURIDAD ALIMENTARIA), TRACEABILITY (TRAZABILIDAD O RASTREABILIDAD), AND THE APPLICATION OF THE PRECAUTIONARY PRINCIPLE (PRINCIPIO PRECAUTORIO).</span><span style="font-weight:bold"> </span><span>This Chamber, in resolution 13924-2011 of 17:59 hours on May 10, referred to the topic of agri-food safety: “</span><span style="font-style:italic">The right to food has been incorporated into most legal systems as a human right, today recognized in International Treaties and even elevated in many countries to constitutional rank. Agri-food law must be understood as the set of special rules, systematically ordered, that regulate the agri-food product and its production chain in all its phases, from production to consumption, controlling the stages of the agri-food enterprise and its productive activity for the purpose of guaranteeing the dietary consumption of healthy and innocuous products, in order to protect the health of persons, animals, and plants, or to ensure the food supply of the population. From the foregoing definition derives the interpreter's need to contribute to the formulation and systematization of those special rules, in order to establish, within the framework of a general theory of agri-food law, what is the object, the subjects, the possible normative sources, the activities, and general principles that should guide the discipline. The demands of quality and healthiness in turn impose requirements for</span><span style="font-style:italic"> </span><span style="font-weight:bold; font-style:italic">traceability (trazabilidad o rastreabilidad)</span><span style="font-style:italic"> </span><span style="font-style:italic">of the product throughout the entire agri-food chain. In the different spheres of activity, the global approach ‘from farm to table’ is adopted, which characterizes this policy and consolidates the indivisible character of the food chain, and focuses on the decisive role played by the National Animal Health Service. The conditions of any traceability system are: 1. At all stages of the chain, food safety must be ensured; 2. Agri-food companies must be able to identify any subject in the chain; 3. Companies must establish the necessary procedures and methods for this purpose; 4. Systems and procedures must be implemented to be able to identify the products delivered; 5. Marketed foods must be identified for the purpose of determining their origin. The need to find a balance between food safety protection mechanisms for preventive purposes -precautionary principle-, and the guarantee of the free circulation of agri-food products that meet international scientific standards is evident. The foregoing produces, as a requirement, the ‘monitoring’ of agricultural and food products, that is, traceability throughout the entire chain, in order to determine the eventual liability that may correspond to the agricultural producer or the company processing products into food, even at each phase of the chain</span><span>.” On the other hand, the Phytosanitary Protection Law (Ley de Protección Fitosanitaria), No. 7664 of April 8, 1997, also incorporates norms to avoid and prevent the introduction and spread of pests that threaten food safety and the economic activity sustained in agricultural production, preventing such measures from unnecessarily constituting an obstacle to free trade (Article 2). For that reason, mechanisms are established for the control of establishment, registration, and inscription of inputs for agricultural use, even establishing norms of agro-environmental liability when damages and losses are caused to agriculture, the environment, and human and animal health (Chapter IV). Within this context, the use of agrochemicals acquires particular relevance for the exercise of agricultural productive activity, a topic on which multiple regulations exist at the national, regional, and international normative level (Article 47). Because, precisely, its regulation is fundamental, within the framework of the agricultural competitiveness of producers on a global scale. In that context, national laws are enacted that introduce, or at least attempt to do so, integrated systems of agri-food and agro-environmental control, to guarantee the safety of persons, the environment, and plants and animals, and even to avoid excessive contamination of water resources. Without a doubt, the rational use of synthetic pesticides for agricultural use promotes the competitiveness of the agricultural and livestock sector, and that is why the regulation is inspired by the creation of a balanced and modern registration system. It is a clear example of the effort to give completeness and organicity to a large quantity of norms scattered throughout the legal system, to respond to the demands of specialized international regulations, emanating both from the World Trade Organization, and from Specialized Agencies, the FAO, and the WHO, closely linked to the Codex Alimentarius, and to International Environmental Conventions. That is why the Decree is issued jointly by the Presidency, and the Ministers of Agriculture, Health, Environment and Energy, and Economy, Industry and Commerce. It is evident that the phenomenon links the entire agricultural and livestock production process, and even the entire prior phase of production, registration, control, and supervision of pesticides used in the agri-productive chain.</span></p><p style="margin-top:0pt; margin-left:64.35pt; margin-bottom:0pt; text-indent:28.35pt; text-align:justify; background-color:#ffffff"><span style="font-weight:bold">VII.- ON THE REDUCTION OF HEALTH AND ENVIRONMENTAL RISKS, IN ACCORDANCE WITH THE PROVISIONS OF ARTICLE 5 OF THE INTERNATIONAL CODE OF CONDUCT ON THE DISTRIBUTION AND USE OF PESTICIDES.</span><span> </span><span>It is of interest to refer to the provisions of the cited International Code of Conduct on the Distribution and Use of Pesticides, which was adopted for the first time in 1985 by the twenty-fifth session of the conference of the Food and Agriculture Organization of the United Nations (FAO). As explained in the preface of the revised version (adopted by the 123rd session of the FAO Council, November 2002), said code of conduct was adopted and has been revised with the purpose of achieving greater food security and, at the same time, protecting human health and the environment. For these purposes, standards of conduct are established to serve as a framework and point of reference for the adequate and rational use of pesticides, focusing on risk reduction, the protection of human and environmental health, and support for the development of sustainable agriculture through the effective use of pesticides [source: (Source:</span><span> </span><a href="http://www.fao.org/agriculture/crops/core-themes/theme/pests/pm/code/en/" style="text-decoration:none"><span style="text-decoration:underline; color:#0000ff">http://www.fao.org/agriculture/crops/core-themes/theme/pests/pm/code/en/</span></a><span>(05/08/11)] In this context, said code of conduct establishes, in its Article 5, the following obligations for governments and the pesticide industry:</span></p><p style="margin-top:0pt; margin-left:64.35pt; margin-bottom:0pt; text-indent:28.35pt; text-align:justify; background-color:#ffffff"><span style="font-weight:bold; font-style:italic">“Article 5. Reduction of health and environmental risks</span></p><p style="margin-top:0pt; margin-left:64.35pt; margin-bottom:0pt; text-indent:28.35pt; text-align:justify; background-color:#ffffff"><span style="font-weight:bold; font-style:italic">5.1</span><span style="font-style:italic"> </span><span style="font-style:italic">Governments should:</span></p><p style="margin-top:0pt; margin-left:64.35pt; margin-bottom:0pt; text-align:justify; background-color:#ffffff"><span style="font-weight:bold; font-style:italic">5.1.1</span><span style="font-weight:bold; font-style:italic"> </span><span style="font-style:italic">implement a system for the registration and control of pesticides as indicated in Article 6;</span></p><p style="margin-top:0pt; margin-left:64.35pt; margin-bottom:0pt; text-align:justify; background-color:#ffffff"><span style="font-weight:bold; font-style:italic">5.1.2</span><span style="font-style:italic"> </span><span style="font-style:italic">periodically review the pesticides marketed in their own country, their acceptable uses and their availability for each sector of the public, and conduct special reviews when scientific evidence so advises;</span></p><p style="margin-top:0pt; margin-left:64.35pt; margin-bottom:0pt; text-align:justify; background-color:#ffffff"><span style="font-weight:bold; font-style:italic">5.1.3</span><span style="font-style:italic"> </span><span style="font-style:italic">carry out a health monitoring program for persons exposed to pesticides in their work, and investigate and document cases of poisoning;</span></p><p style="margin-top:0pt; margin-left:64.35pt; margin-bottom:0pt; text-align:justify; background-color:#ffffff"><span style="font-weight:bold; font-style:italic">5.1.4</span><span style="font-style:italic"> </span><span style="font-style:italic">provide guidance and instructions to health personnel, physicians, and hospital staff for the treatment of suspected cases of pesticide poisoning (25);</span></p><p style="margin-top:0pt; margin-left:64.35pt; margin-bottom:0pt; text-align:justify; background-color:#ffffff"><span style="font-weight:bold; font-style:italic">5.1.5</span><span style="font-style:italic"> </span><span style="font-style:italic">establish national or regional information and control centers for poisoning cases at strategic locations, so that they can provide immediate guidance on first aid and medical treatment, and be accessible at all times (25);</span></p><p style="margin-top:0pt; margin-left:64.35pt; margin-bottom:0pt; text-align:justify; background-color:#ffffff"><span style="font-weight:bold; font-style:italic">5.1.6</span><span style="font-style:italic"> </span><span style="font-style:italic">use all possible means to collect reliable data and maintain statistics on the health aspects of pesticides and pesticide poisoning incidents, in order to establish the harmonized WHO system for the identification and recording of such data (25). They should have suitably trained personnel and sufficient resources to ensure that accurate information is collected;</span></p><p style="margin-top:0pt; margin-left:64.35pt; margin-bottom:0pt; text-align:justify; background-color:#ffffff"><span style="font-weight:bold; font-style:italic">5.1.7</span><span style="font-style:italic"> </span><span style="font-style:italic">provide extension and advisory services, as well as farmers' organizations, with adequate information on practical IPM strategies and methods and on the variety of pesticide products available for use;</span></p><p style="margin-top:0pt; margin-left:64.35pt; margin-bottom:0pt; text-align:justify; background-color:#ffffff"><span style="font-weight:bold; font-style:italic">5.1.8</span><span style="font-style:italic"> </span><span style="font-style:italic">ensure, with the cooperation of the pesticide industry, that in cases where pesticides are distributed through the same channels as food, clothing, medicines, and other products for consumption or topical application, such pesticides are physically separated from other goods to prevent contamination and/or mistaken identity. Furthermore, where appropriate, they should be clearly marked as hazardous materials.</span></p> Every effort should be made to disseminate information about the dangers of storing food and pesticides together (26); **5.1.9** use all possible means to collect reliable data, maintain statistics on environmental contamination, and report specific incidents related to pesticides; **5.1.10** implement a program for monitoring pesticide residues in food and in the environment.

**5.2** Even where a control program is in place, the pesticide industry should:

**5.2.1** cooperate in the periodic reassessment of the pesticides being marketed; **2.** provide information on the hazards related to pesticides and on appropriate treatment to centers dealing with pesticide poisoning and to their medical personnel; **5.2.3** make every reasonable effort to reduce the risks posed by pesticides:

**5.2.3.1** by making less toxic formulations available; **5.2.3.2** by presenting products in ready-to-use containers; **5.2.3.3** by developing application methods and equipment that minimize exposure to pesticides; **5.2.3.4** by using returnable and refillable containers where effective container collection systems exist; **5.2.3.5** by using containers that are not attractive or easy to reuse and promoting programs that discourage their reuse, where effective collection systems do not exist; **5.2.3.6** by using containers that are not attractive to children or easily opened by them, particularly for household products; **5.2.3.7** by employing clear and concise labeling; **4.** discontinuing the sale and withdrawing products when their handling or use involves an unacceptable risk under any of its use indications or restrictions.

**5.3** Governments and industry should also cooperate in reducing risks by:

**5.3.1** promoting the use of appropriate and affordable personal protective equipment (5); **5.3.2** establishing provisions for the safe storage of pesticides both in warehouses and on farms (26, 27); **5.3.3** establishing services for the collection and safe disposal of used containers and small quantities of unused pesticides (28); **5.3.4** protecting biodiversity and minimizing the adverse effects of pesticides on the environment (water, soil, and air) and on non-target organisms.

**5.4** To avoid cases of confusion and unjustified public alarm, stakeholders should consider all available data and promote the responsible dissemination of information on pesticides and their uses.

**5.5** When establishing production facilities in developing countries, manufacturers and governments should cooperate to:

**5.5.1** adopt technical standards and follow practices appropriate to the nature of the manufacturing operations and the resulting hazards, and ensure the availability of appropriate protective equipment; **5.5.2** take all necessary precautions to protect workers, other persons present, surrounding communities, and the environment; **5.5.3** ensure the appropriate siting of manufacturing and formulation plants and adequate control of their wastes and effluents; **5.5.4** maintain quality assurance procedures to ensure compliance with relevant standards of purity, performance, stability, and safety." **VIII.- ON THE REGULATION OF PESTICIDE REGISTRATION.** The proper use of pesticides can be useful for the control and elimination of pests, benefiting the food security of the population and the economic activity based on agricultural production. However, the potential risk that the use of such substances may pose to human health and the environment must be acknowledged. This has even motivated the adoption of international instruments with the express objective of protecting human health—including the health of consumers and workers—and the environment from the possible harmful effects of pesticides, as is the case with the Rotterdam Convention on the Prior Informed Consent Procedure for Certain Hazardous Chemicals and Pesticides in International Trade, which was approved by Costa Rica through Law No. 8705 of February 13, 2009. In that instance, before the mandatory legislative consultation on constitutionality brought before this Court (case file number 08-015252-0007-CO), prior to the approval of said international instrument, this Court stated—in what is relevant—that:

"(...) the Costa Rican State has the duty to act effectively and proactively to prevent the occurrence of events that degrade the environment and compromise its sustainability. From that perspective, committing, through an international treaty such as the one consulted, or through a domestic act, to facilitate the rational use of chemically hazardous products subject to international trade, is not only possible but entirely consistent with its constitutional duties. Pesticides and industrial chemical products are substances that can cause harm to human health and the environment. Faced with such a threat, the Rotterdam Convention provides the Parties with the possibility of knowing in advance the composition and effects of certain chemical products, which are expressly listed in its Anexo III. The suitable measures that the State takes to regulate the marketing and use of such products in industrial, agricultural activities, etc., are consistent with its duty to preserve the aforementioned values of constitutional rank. Hence, the duties that the State would assume if it definitively approves this Convention are legitimate, in accordance with the Law of the Constitution. It would be a sovereign decision of the State to submit to the obligations contained in the Convention, to contribute to the protection of people's health and the integrity of the environment, so it can be concluded that, in general terms, no unconstitutionality defects are observed in the clauses of the Rotterdam Convention, the approval of which is submitted for consultation." (resolution number 2008-018207 at 6:15 p.m. on December 10, 2008)

This verifies that this Court has recognized the risk that pesticide use can entail and the importance of adopting suitable measures to regulate their use. In the Costa Rican legal system, there is diverse legal and regulatory normativity from which it follows that the activity of importing, manufacturing, marketing, and using pesticides is strongly subject to the State's police power (potestad de policía), in order to guarantee the right to health and to a healthy and ecologically balanced environment. One can cite, first, the Ley General de Salud, which in its article 213 provides:

"ARTICLE 213.- Every person, natural or legal, engaged in producing food, must do so under sanitary environmental conditions and using defense or preservation techniques approved by the health authority, in order to avoid, mainly, the contamination of such products and their dangerousness due to the presence of toxic residues from their treatment with pesticides or other defense or preservation systems." Meanwhile, article 244 of that same regulatory body establishes:

"ARTICLE 244.- Natural and legal persons that import, manufacture, handle, store, transport, trade, supply, or apply substances, mixtures of substances, or products called pesticides under the plant health law, shall be subject to the regulatory provisions issued by the Ministry in mutual agreement with the Ministry of Agriculture to safeguard the health of people in accordance with that law; interested parties must register every pesticide or product intended for the control or extermination of infestations and request prior permission to operate when such substances, mixtures of substances, or products that, due to their nature or use, are not included in the aforementioned law, could somehow produce poisonings or serious damage to the health of people or animals that are useful or harmless to man." For its part, through the Ley de Protección Fitosanitaria (Law No. 7664 of April 8, 1997), the phytosanitary protection measures established in that law and its regulations were declared of public interest and mandatory application (Art. 1). Furthermore, among the objectives of that law is included: "Regulate the use and handling of chemical, biological, or related substances and equipment for applying them in agriculture; likewise, their registration, importation, quality, and residues, while simultaneously seeking to protect human health and the environment" (article 2, subsection E). The competent authority in the matter is the Servicio Fitosanitario del Estado, which is responsible—among other functions—for: "Controlling chemical, biological, or related substances for agricultural use, regarding their registration, importation, exportation, quality, tolerance, residues, dosages, effectiveness, toxicity, presentation to the public, conservation, handling, trade, general conditions of use, safety, and precautions in transport, storage, disposal of containers and residues of such substances; likewise, controlling the equipment necessary for their application and any other activity inherent to this matter" (article 5, subsection O). In accordance with the above, articles 23, 24, 25, and 30 of said regulatory body provide:

"ARTICLE 23.- Registration of substances and equipment.

According to the requirements to be specified in the regulation of this law, all chemical, biological, or related substances and application equipment for agricultural use must be registered in the registry that the Servicio Fitosanitario del Estado will create to have information on their characteristics and to ensure their correct use in the country." "ARTICLE 24.- Registry of substances.

No natural or legal person may import, export, manufacture, formulate, store, distribute, transport, repackage, refill, advertise, handle, mix, sell, or use chemical, biological, or related substances for agricultural use that are not registered in accordance with this law.

Excepted from the indicated registry are chemical, biological, or related substances for agricultural use that enter in transit, for research, or to combat specific phytosanitary problems. In these cases, the permit will only be granted temporarily for reasons of urgency, technically justified before the Servicio Fitosanitario del Estado.

The Service shall deny authorization when it is technically inapplicable and shall notify the interested party." "ARTICLE 25.- Registration of persons.

Every natural or legal person that registers, imports, exports, repackages, and refills chemical, biological, or related substances and application equipment for agricultural use must register in the registry kept by the Servicio Fitosanitario del Estado, upon prior fulfillment of the requirements set forth in the respective regulation.

The Service may deny, suspend, or cancel the registry of chemical, biological, or related substances and application equipment for agricultural use, by means of a substantiated technical resolution that shall adhere to due process, in accordance with the respective regulation." "ARTICLE 30.- Prohibitions and restrictions for technical reasons.

The Ministry of Agriculture and Livestock may restrict or prohibit the importation, transit, redestination, manufacture, formulation, refilling, repackaging, storage, sale, mixing, and use of chemical, biological, or related substances and application equipment for agricultural use, when justified for technical reasons and it is considered that their use is harmful to agriculture, health, or the environment." Finally, the Ley para la Importación y Control de la Calidad de Agroquímicos (Law No. 7017 of December 17, 1985) states, in its article 5, that:

"ARTICLE 5.- For the purpose of ensuring the quality and use of agrochemicals, the Ministry of Agriculture and Livestock is obligated to carry out periodic controls on the quality of these products in factories and distribution houses, where it shall take the necessary samples to send them to the quality control laboratory. This Ministry shall also be in charge of controlling chronic toxicity and its effect on people's health and the environment. No product may be registered without these analyses having been performed. The Ministry of Agriculture and Livestock may prohibit the circulation of or order the destruction of products that do not meet quality standards, as well as take other measures aimed at improving the quality of agrochemicals. Regarding the development and control of quality standards, the cited Ministry shall act in coordination with the Oficina Nacional de Normas y Unidades de Medidas of the Ministry of Economy and Commerce." It follows from the previously cited regulations that, as a manifestation of the referred police power, the necessary registration of pesticides is included prior to authorizing their importation, manufacture, marketing, or use, in order to exercise prior control over due compliance with the corresponding technical requirements of quality and safety, protecting public health and the environment." The following main ideas are drawn from all of the above, which serve as the basis for this note:

*The right to food (derecho a la alimentación)* as a human right imposes food security and thus requires traceability (trazabilidad) or trackability of the product throughout the entire food chain ("from farm to table"). For that reason, control mechanisms for the establishment, registration, and inscription of inputs for agricultural use are established, even establishing agro-environmental liability rules when damages and losses to agriculture, the environment, and human and animal health occur.

*Integrated agri-food and agro-environmental control systems (sistemas integrados de control)* are therefore established to guarantee the safety of people, the environment, and plants and animals, and even to avoid excessive contamination of water resources.

*According to the International Code of Conduct on the Distribution and Use of Pesticides (Código Internacional), which was first adopted in 1985 at the twenty-fifth session of the conference of the United Nations Food and Agriculture Organization (FAO), standards of conduct are established to serve as a framework and reference point for the proper and rational use of pesticides, focusing on risk reduction, protection of human and environmental health, and support for the development of sustainable agriculture through the effective use of pesticides. Also, see the Rotterdam Convention on the Prior Informed Consent Procedure for Certain Hazardous Chemicals and Pesticides in International Trade (Convenio de Rotterdam), which was approved by Costa Rica through Law No. 8705 of February 13, 2009.

*The use of pesticides, while potentially useful for the control and elimination of pests, benefiting the food security of the population and economic activity based on agricultural production, also requires acknowledging the potential risk that the use of such substances may pose to human health and the environment. Therefore, as a manifestation of the State's police power, the necessary prior registration of pesticides is required before authorizing their importation, manufacture, marketing, or use, in order to exercise prior control over due compliance with the corresponding technical requirements of quality and safety, protecting public health and the environment.

Furthermore, the constitutional jurisprudence on the principle of progressivity and the principle of non-regression in environmental matters must be remembered.- The principle of progressivity (principio de progresividad) imposes on the State the obligation to progressively increase, within its means and development, the level of protection of the right to the environment. It is the obligation to develop and implement policies and norms aimed at progressively achieving the full effectiveness of the right to the environment. The principle of non-regression (principio de no regresión) stands as a substantive guarantee of the right to a healthy and ecologically balanced environment, by virtue of which the State is obliged not to adopt measures, policies, or approve legal norms that worsen the status of rights achieved up to that point (see ruling 2016-00415). In this case, it is verified that the decree repealed by the decree in question was much more adequate, complete, and rigorous for the entry and control of pesticides. This confirms the regressivity in this matter.

Comparing the regulation imposed by the challenged decree with the prior regulation, the regressivity is evident and, along with it, the lack of progressivity in the protection of health and the environment regarding the regulation of pesticide registration and use in our country.

<span style="text-decoration:underline">Grave danger to the environment and public health: </span>The great concern expressed about the quality of pesticides that could be released into agricultural fields and the environment is alarming, given that, first, IAGTs are registered by equivalence or revalidated without the technical information necessary for an assessment of risks to health and the environment, which contravenes the recommendations of the OECD (which establishes the need to conduct a risk assessment prior to the registration of chemical substances, such as pesticides); and second, by not requiring the submission of biological tests for the registration of formulated products containing unevaluated IAGTs, a lack of knowledge of the effects on humans and the environment is inferred, as well as uncertainty as to whether the product fulfills its pest control function.

<span style="text-decoration:underline">Transcendence of the matter at hand for human health:</span> The transcendence of the matter dealt with here must be recalled, since pesticides have a direct impact on human health. The agrochemical and biological substances used in agriculture can represent harm—or a risk of violation. These agrochemicals reach the cultivated foods directly, and then, the tables of all consumers. Thus, agricultural inputs, particularly pesticides, are susceptible to causing irreparable damage to the environment and health, especially if used incorrectly; therefore, the State must issue rules and adopt the necessary measures so that all activity related to agrochemical products, particularly pesticides, conforms to the duty to preserve health and the environment. As mentioned by the petitioner, the Human Rights Council of the United Nations General Assembly, through resolution 34/12 (A/HRC/RES/34/12), stated regarding the right to food, approved on March 23, 2017, in its paragraph 41, “<span style="font-style:italic">Invites States to promote practices that minimize the potential health and environmental risks associated with pesticides, while ensuring their effective use</span>.” Furthermore, Article 5, “Reduction of health and environmental risks,” of the International Code of Conduct on Pesticide Management, of the FAO and WHO, establishes that governments should implement a pesticide registration and control policy and system in accordance with Article 6, which it transcribes, that sets out policies and legislation, establishes systems and infrastructures so that each pesticide product is registered before being made available, risk assessments and the adoption of risk management decisions, and the application of the principles described in the Manual on the development and use of FAO and WHO specifications for plant protection products, for the purpose of determining equivalence among pesticides.

<span style="text-decoration:underline">Violation of the preventive principle, precautionary principle, pro natura principle, and principle of objectification of environmental protection:</span> The challenged regulation is contrary to what the constitutional principles on environmental matters mandate: <span style="font-weight:bold; font-style:italic">preventive</span> principle (when there is certainty of possible damage to the environment, the affecting activity must be prohibited, limited, or conditioned upon the fulfillment of certain requirements. In general, this principle applies when there are risks that are clearly defined and identified as at least probable; likewise, this principle is useful when there are no technical reports or administrative permits that guarantee the sustainability of an activity, but there are sufficient elements to foresee eventual negative impacts), <span style="font-weight:bold; font-style:italic">precautionary</span> principle (when there is danger of serious and irreversible damage, the lack of absolute scientific certainty shall not be used as a reason to postpone the adoption of cost-effective measures to prevent environmental degradation. The principle departs from reasonable scientific uncertainty combined with the threat of serious and irreversible environmental damage), <span style="font-weight:bold; font-style:italic">pro natura</span> principle (in case of doubt or uncertainty, controversies must be resolved and rules must be interpreted in favor of the protection and conservation of the environment), and the principle of <span style="font-weight:bold; font-style:italic">objectification of environmental protection</span> (or principle of linkage to science and technology, according to which it is required to substantiate decision-making in this matter with technical studies, both in relation to acts and to provisions of a general nature—both legal and regulatory—from which the requirement of “linkage to science and technology” is derived, thereby conditioning the Administration's discretion in this matter. It has been defined as Principle 17 of the Rio Declaration on the Environment). When facing a situation that requires the application of the precautionary principle, public entities and bodies must refrain from authorizing, approving, or permitting any new or modification request that reasonably implies a serious risk; they are even obligated to suspend activities that are underway, and in parallel must efficiently adopt all measures required for the preservation of a healthy and ecologically balanced environment. Therefore, the application of the precautionary principle implies that when there are indicators that a certain activity could plausibly cause serious and irreversible damage to the environment, the lack of absolute certainty or scientific evidence in this regard does not exempt from the obligation to adopt all those efficient and effective measures to prevent a violation of the environment. Furthermore, in light of the theory of <span style="font-style:italic">Drittwirkung der Grundrechte</span>, this principle extends its guiding function to the conduct of both public and private legal subjects.

The foregoing is violated by the decree in question. Thus, to further highlight the importance of protecting the right to the environment, health, and food security, and in application of the constitutional environmental principles of progressivity and non-regression, the precautionary principle, the preventive principle, the in dubio pro natura principle, and the principle of objectification, I have considered it appropriate to record this note in the terms expressed.

Fernando Cruz Castro 1

Res. n.°2023-002389 SALA CONSTITUCIONAL DE LA CORTE SUPREMA DE JUSTICIA. San José, a las trece horas y cuarenta y cinco minutos del primero de febrero de dos mil veintitrés.

Acción de inconstitucionalidad interpuesta por [Nombre 001], portador de la cédula de identidad n.°[Valor 001], en su calidad de presidente de la junta directiva de la ASOCIACIÓN PARA EL MOVIMIENTO DE AGRICULTURA ORGÁNICA COSTARRICENSE, en contra del decreto ejecutivo n.°41481-MAG denominado “Reforma Reglamento para la actualización de la información de los expedientes de registro de ingrediente activo grado técnico y plaguicidas formulados”.

RESULTANDO:

1.- Por escrito recibido en la Sala Constitucional a las 16:14 hrs. del 04 de abril de 2019, el señor [Nombre 001], portador de la cédula de identidad n.°[Valor 001], en su calidad de presidente de la junta directiva de la “Asociación para el movimiento de agricultura orgánica costarricense” interpone acción de inconstitucionalidad en contra del decreto ejecutivo n.°41481-MAG, publicado el 11 de enero de 2019 mediante alcance n.°8 del diario oficial La Gaceta, por considerarlo contrario a los arts. 21 y 50 de la Constitución Política y al principio precautorio.

En cuanto a su legitimación, asevera el accionante que acude a esta Sala Constitucional con base en el derecho fundamental a un ambiente sano y ecológicamente equilibrado contenido en el art. 50 de la Constitución Política y en otras normas.

Como antecedente, indica que en noviembre de 2018 la Federación Costarricense para la Conservación de la Naturaleza presentó una acción de inconstitucionalidad en contra del decreto ejecutivo n.°39995-MAG, la cual se tramita en el expediente n.°18-019039-0007-CO. Alega que el día 11 de enero de 2019 se publicó el decreto impugnado, el cual, según el dicho del accionante, carece de criterio técnico y científico y ahonda aún más el riesgo químico, ambiental y a la salud humana y animal en contravención de lo indicado en los arts. 21 y 50 constitucionales. Se cuestiona que este decreto no es una reforma parcial sino que es una reforma total solapada al decreto supra citado n.°39995.

Sobre el fondo el accionante aduce lo siguiente: la Ley de Protección Fitosanitaria, ley n.°7664 declara de interés público y de aplicación obligatoria las medidas de protección fitosanitaria establecidas en dicha norma legal, cuyo objeto es la protección de los productos vegetales, a efectos de evitar las plagas y prevenir afectaciones a la seguridad alimentaria y a la actividad económica sustentada en la producción agrícola. Dicha ley asignó al Servicio Fitosanitario del Estado (SFE) el control y vigilancia de la salud alimentaria vegetal. Indica que tales labores se complementan con otras asignaciones competenciales relacionadas con el Ministerio de Ambiente y Energía (MINAE), derivadas de la Ley de Uso, Manejo y Conservación de los Suelos, ley n.°7779. El registro de plaguicidas, asignado al SFE, no se agota en un análisis de verificación de requisitos, sino que debe realizarse un análisis científico relacionado con la evaluación del riesgo. Así, es que de manera conjunta el Ministerio de Agricultura (MAG), el Ministerio de Salud y el MINAE deben intervenir en el proceso de registro, post registro y reválida o actualización de la información de los plaguicidas; considerándose que tales productos tienen incidencias directas y/o indirectas en el ambiente en general, en tanto puede tener afectaciones también en la biodiversidad (flora y fauna) y consecuentemente, en la salud de las personas. Aún más cuando en este caso del proceso de actualización o reválida estamos hablando que no es una simple actualización, sino es un análisis científico de la información presentada por el registrante para realizar la respectiva evaluación de riesgo, debido a que de estos productos, no se conoce sus externalidades en el ambiente ni en la salud. La función encomendada al SFE de “registrar” plaguicidas no debe ser entendida como una actuación meramente mecánica de la Administración, en la que se hace una simple constatación o verificación de un listado de requisitos, establecidos en la normativa aplicable, ya sea de orden legal o reglamentaria. Al contrario, y como lo señaló en su informe n.°FOE-AM-19/2004 la Contraloría General de la República (CGR): se trata de una función esencial en la tutela del ambiente y la salud, la cual debe de ser ejercida conforme a la normativa nacional e internacional.

Análisis pormenorizado de los agravios Sobre el art. 1 La reforma parcial y adición al decreto ejecutivo n.°39995 es un beneficio a los comercializadores de plaguicidas, pues amplían el tiempo a partir de la publicación del decreto impugnado otorgando el beneficio de cinco años más a esos productos sin que los mismos hayan pasado por una evaluación de riesgo y concediendo ese tiempo adicional para que los dueños registrales puedan presentar la información. Han transcurrido seis años, que fue el tiempo límite definido en la ley n.°8702 para presentar la información y que los ministerios involucrados en el proceso registral evaluaran dicha información. Ahora, con este decreto promulgado, la empresa privada en alianza con el despacho ministerial está ampliando el tiempo para que dichos productos se puedan comercializar en el país sin que se haya evaluado la información toxicológica crónica, ecotoxicológica y destino ambiental. Con este accionar pareciera que las empresas comercializadoras de plaguicidas no cuentan con la información propia de los estudios que se deben presentar, los cuales tienen que estar apegados a los principias de ciencia y técnica como lo establece la normativa nacional e internacional. Lo único que se busca es extender el tiempo para seguir vendiendo productos químicos sin una evaluación integral, lo que evidencia que el discurso del año 2011 solo fue una posición de meros trámites en tanto se les permita seguir contaminando al ambiente y jugando con la salud de los costarricenses con productos que carecen de información propia o equivalencia química para la realización de una evaluación química, toxicológica y ecotoxicológica para realizar la evaluación del riesgo y de esta manera se pueda tomar la decisión sobre si se permite o no que se siga comercializando el producto en Costa Rica, o, si es del caso, bajo qué circunstancias se puede seguir comercializando o vendiendo el producto sin ninguna restricción. Aun cuando en este mismo numeral se define una lista taxativa de requisitos, estos son limitados para realizar una evaluación de riesgo. Además, el decreto debe ser aplicado e interpretado por los analistas de registro de los distintos ministerios de manera integral con la dispuesto en el ordenamiento jurídico sobre la materia, es decir, en modo alguno puede entenderse que se constituye en un cuerpo normativo aislado del resto del bloque de legalidad. Lo que persigue el despacho ministerial con la promulgación de este tipo de documentos es exigir, ordenar o intimidar a los evaluadores de registro que se circunscriban únicamente a solicitar una limitada información, que carece de sustento técnico y científico para realizar una evaluación de riesgo de acuerdo a las normas nacionales e internacionales con requisitos diezmados que se apartan de lo ya indicado por la CGR en sus informes 19-2004 y 238-2006, entorpeciendo de esta manera realizar una evaluación científica concordante con la Ley General de la Administración Pública (LGAP) en cumplimiento de los arts. 21 y 50 constitucionales. Los funcionarios evaluadores de la información registral, en cumplimiento de esa responsabilidad constitucional, están obligados a solicitar mediante razonamiento técnico la información que necesiten para asegurar que el plaguicida no tenga externalidades negativas a la salud y ambiente. En el artículo de marras nuevamente el MAG insiste en el proceso de información referenciada como lo indicaba tácitamente en el decreto n.°39995-MAG, que prácticamente queda derogado con la publicación de este nuevo decreto, que indica lo siguiente:

“En caso que exista especificación internacional para el ingrediente activo grado técnico objeto de actualización, debe ser proveído por el solicitante a efecto de acreditar que el material técnico que se está sometiendo al proceso de actualización no contenga impurezas relevantes en niveles superiores de los estándares internacionales reconocidos, las únicas informaciones internacionales que puede aportar es información referenciada de otro producto”.

Sin información propia o referenciada como lo propone este reglamento, el Poder Ejecutivo y la industria de plaguicidas lo que buscan es facilitar el comercio de plaguicidas en contra de la salud humana, animal y el medio ambiente. Entonces, se propone evaluar un plaguicida cuya información y sus características químicas y físicas son de otro producto que está como información general en internet, que no tiene ninguna relación entre sí con el producto a revalidar o registrar. Si se refieren a un mismo ingrediente activo, lo mínimo que se puede realizar acorde con la norma nacional e internacional es el estudio de equivalencia química.

Sobre el art. 2 La reforma planteada disminuye el tiempo para que los evaluadores tomen una decisión y se pasa de tres meses definida en el decreto ejecutivo n.°39995 a un mes en la modificación planteada en el decreto n.°41481-MAG. Se evidencia en este tipo de normativa que lo que se busca es el beneficio a las empresas vendedoras de agroquímicos, para que los analistas de registro realicen el análisis presionados por el tiempo, sin que se evidencie de un estudio de cargas de trabajo para determinar el tiempo propuesto, pero lo más grave es que dicho análisis planteado en este decreto está definido como una simple constatación de documentos químicos, es decir, si los registrantes presentaron o no la información, pero es tal el grado de descoordinación que esta verificación de documentos que son de índole química se lo asignan a los profesionales en agronomía, quienes no tienen las competencias ni la formación para realizar esta tarea. Esta propuesta planteada es una nueva modalidad de registro que solo se realiza con un simple “check list” o lista de verificación.

Sobre el art. 3 Nuevamente el despacho ministerial acorta el tiempo establecido en el decreto ejecutivo n.°39995 en beneficio de los usuarios, sin que se conozca si se tiene un estudio técnico de cargas de trabajo que sustente tal decisión de pasar de tres meses a diez días para realizar la evaluación técnica por parte de funcionarios del SFE, pues en este decreto exceptúan en forma unilateral la participación en temas de salud y ambiente a los ministerios correspondientes. Queda de nuevo en evidencia la priorización del despacho ministerial, cual es el favorecimiento a la industria vendedora de agroquímicos de tener sus registros en el menor tiempo posible y sin la evaluación técnica del riesgo, que incumple los deberes del Estado en materia de registro de agroquímicos establecidos en consonancia con los arts. 21 y 50 constitucionales.

El párrafo cuestionado por el accionante señala que “a los plaguicidas formulados que no cuentan con un registro de ingrediente activo grado técnico asociado a esa formulación y que el fabricante de ese formulado haya sido actualizado conforme este reglamento, el SFE le otorgará, el certificado de registro de ingrediente activo grado técnico”. El decreto se opone a cualquier principio técnico científico activo que rige la materia de registro, pues es otorgar un registro sin mediar siquiera en proceso básico que rige la normativa de registro, que es la evidencia química.

Sobre el art. 4 (que reforma el art. 5 del decreto n.°39995) El proceso de facilitación registral que establece el decreto ejecutivo n.°414131 va en contra del deber ser del Estado de proteger a toda la sociedad costarricense. Solamente se enumeran requisitos para salir del paso, que no van a sustentar ninguna información para realizar una evaluación técnica científica de análisis de riesgo. Este tema en particular, debido a que toda esta propuesta normativa es un retroceso a la normativa establecida en el país, es volver al período anterior o igual al año 2004 en desconocimiento de los dictámenes de la CGR.

Sobre el art. 5 (que reforma el art. 6 del decreto n.°39995) El proceso de equivalencia química propuesto en este artículo se contrapone a las normas internacionales, sentencia de Sala Constitucional n.°2011-016937 y a los informes de la CGR. No se ha propuesto por parte de estas instituciones un procedimiento para la evaluación de la equivalencia en los productos formulados y alude al Manual sobre especificaciones de plaguicidas y equivalencia CropLife 2014.

La propuesta para que el SFE confeccione y publique una base de datos con información toxicológica, ecotoxicológica y destino ambiental se puede circunscribir a lo ya indicado por SANCO, pues la información sensible que se puede catalogar como derecho de autoría es confidencial y de ahí que no es una solución como se plasma en este decreto para tener toda la información de un producto.

Sobre el art. 6 (que reforma el art. 7 del decreto n.°39995) Con una propuesta de registro acientífica, que se aparta de normas nacionales e internacionales, la cual podría ser inconstitucional, el Poder Ejecutivo promulgó este decreto que, en congruencia con el objetivo del mismo, lo debió titular “normativa para la facilitación registral”, pues la prioridad es la actualización o reválida de registro con información referenciada, presionando a los analistas de registro al acortar los tiempos de respuesta, proponiendo el proceso de registro con solo una simple verificación de la información y separando a los ministerios de salud y ambiente en su análisis de registro.

Sobre el art. 9 (que reforma y adiciona un nuevo art. 11 del decreto n.°39995) Siguiendo con el proceso de facilitación de registro y sin mediar ningún análisis que responda a un sustento técnico y científico de acuerdo a normas nacionales e internacionales, el Poder Ejecutivo se propone homologar los usos de un producto con otro que tenga similitud con el ingrediente activo, concentración y formulación, cuando en este caso particular lo mínimo que se puede realizar es la equivalencia química del ingrediente activo, pero como se refiere a un formulario deben ser analizados los coformulantes, que se deben declarar y poder realizar el análisis de riesgo por parte de los ministerios de salud y ambiente y presentar un estudio de eficacia biológica respetando las reglas unívocas de la ciencia y la técnica. Hay que tomar en consideración que un producto formulado está compuesto por un porcentaje del ingrediente activo y el resto conocido como coformulantes, y mal llamados inertes. Muchas veces el secreto del producto formulado no está en la composición del ingrediente activo sino en los coformulantes, algunas de los cuales son mucho más tóxicos para la salud y el ambiente que el propio ingrediente activo. Este tipo de decreto lo único que busca es dar más tiempo a las empresas vendedoras de agroquímicos para que sigan con el proceso de la comercialización y el uso de sustancias que son peligrosas y que pueden ocasionar un grave daño a la salud de la población costarricense, afectar la biodiversidad y dañar el medio ambiente, pues los registros no han sido evaluados integralmente. En otras palabras, no tienen el estudio de toxicología crónica y a ninguno de estos registros se les ha realizado la valoración ecotoxicológica y muchos podrían no estar funcionando en las dosis que fueron registradas. Este tipo de decreto se podría considerar como una violación a los derechos humanos, porque las autoridades responsables no han actuado con la debida diligencia y siguen postergando con este tipo de decretos la evaluación de la información técnica propia de cada registro. Además, que el decreto carece de fundamentación técnica sobre la materia de plaguicidas y que busca flexibilizar los requisitos, en detrimento de la vida y la salud de las personas, sobre todo de los peones agrícolas y los agricultores.

Solicita que se declare con lugar la acción de inconstitucionalidad.

2.- A través de la resolución de las 15:40 hrs. del 08 de abril de 2019, la Presidencia de la Sala Constitucional dio curso a la presente acción de inconstitucionalidad. Además, se ordenó la publicación de los edictos correspondientes en el Boletín Judicial. Se le confirió audiencia al Procurador General de la República y al Ministro de Agricultura y Ganadería.

3.- Mediante escrito recibido en esta Sala Constitucional el día 9 de mayo de 2019, contestó la audiencia Luis Renato Alvarado Rivera, en su condición de Ministro de Agricultura y Ganadería. En primer lugar, indica que los alegatos esgrimidos por la parte accionante atañen a la sede contencioso administrativa y no a la constitucional por ser la disputa concerniente a cuestiones de legalidad. Para ello, procede a hacer un recuente histórico de varias normas legales relacionadas con la materia fitosanitaria. Dice que si el accionante estima que la norma debió haber sido promulgada junto con otros órganos, tal argumento debería ser discutido en dicha sede y no en la Sala Constitucional. Considera que el decreto ejecutivo en cuestión actúa en prevención del riesgo ambiental y de la salud humana como animal. Agrega que uno de los objetivos de la Ley de Protección Fitosanitaria es regular el uso y manejo de sustancias químicas, biológicas o afines y equipos, para aplicarlas en la agricultura; asimismo, su registro, importación, calidad y residuos, procurando al mismo tiempo proteger la salud humana y el ambiente, por ello las normas jurídicas y técnicas relativas a la protección fitosanitaria, deben ser interpretadas de conformidad con el deber constitucional del Estado y de la sociedad en general de actuar en prevención del riesgo ambiental y de la salud tanto humana como animal, como en efecto se hace al emitir el decreto ejecutivo n.°39995-MAG y el n.°41481-MAG.

Afirma que el legislador le confirió al SFE la competencia para la consecución de los fines contenidos en la Ley de Protección Fitosanitaria y que dicha asignación competencial es exclusiva a dicho órgano, dentro de lo cual cabe la realización y custodia de los registros respectivos. Cita, en complemento de su argumentación, los dictámenes números C-171-2000, C-255-2009 y C-215-2013 de la Procuraduría General de la República (PGR).

Enfatiza que el decreto de actualización de expedientes y su reforma se aplica exclusivamente a todos los registros de “ingrediente activo grado técnico” (IAGT) y productos formulados que fueron inscritos con una normativa (legal o reglamentaria) distinta al decreto ejecutivo n.°33495-MAG-S-MEIC-MINAET, “Reglamento sobre Registro, Uso y Control de Plaguicidas Sintéticos Formulados, Ingrediente Activo Grado Técnico, Coadyuvantes y Sustancias Afines de Uso Agrícola”. Es decir, subraya que solo aplica para aquellos expedientes de registro de productos que ya están en el mercado y que fueron registrados conforme a la normativa aplicable al momento de su aprobación y que eran evaluados integralmente (salud, ambiente y eficacia biológica) conforme a esa normativa; por ello, si el accionante estima que dicha normativa tiene vicios de legalidad debe discutirlos en la sede jurisdiccional correspondiente y no en la sede constitucional. Considera inaceptable e improcedente que el accionante pretenda en sede constitucional discutir aspectos legales que no son resorte de la sede constitucional sino de los tribunales comunes.

Aduce que la parte accionante confunde y pretende confundir respecto de los agroquímicos registrados y que se comercializan actualmente en el país, que es a los que se les aplica el decreto ejecutivo n°39995-MAG y n.°41481-MAG, pretendiendo hacer creer que deben ser nuevamente evaluados, lo que no resulta procedente ni necesario, pues todos los productos inscritos en Costa Rica cumplieron con los requisitos y normativa establecida en el derecho positivo vigente al momento de otorgarse dichos registros. En consecuencia aclara, de manera vehemente y reiterativa, que en ninguno de los productos plaguicidas, sean materias primas o productos formulados que cuentan con registro vigente, existe evidencia o presunción técnica científica o al menos indicios que presuman un peligro adicional o resultante de la aplicación del mismo, en cuanto a la salud humana, el ambiente o la eficacia biológica del plaguicida. Tanto la Sala Constitucional como la PGR han sido claras en el sentido de que tanto el Ministerio de Salud, el de Ambiente, el de Agricultura y hasta particulares pueden acudir a la sede jurisdiccional ordinaria a solicitar la anulación de los actos administrativos, mediante los cuales se otorgaron esos registros e incluso pueden solicitar que precautoriamente se suspenda su comercialización. Sin embargo, ni el Ministerio de Salud, ni el de Ambiente, ni el accionante lo hacen porque carecen de pruebas, sustento científico y técnico y, por eso, acuden temerariamente a la Sala Constitucional a plantear temas de legalidad mediante acciones de inconstitucionalidad, con el único fin y objetivo de entorpecer el proceso de ordenamiento del sistema de registros de agroquímicos que emprendió la Administración.

Insiste que con los decretos mencionados ‒n°39995-MAG y n.°41481-MAG‒ no se están otorgando registros de IAGT o para plaguicidas formulados nuevos, sino que solo aplica a IAGT (materias primas) y formulados viejos.

Hace eco de que todo registro otorgado puede ser revocado o anulado, obviamente mediante el proceso de lesividad, si se demuestra que tiene riesgo inaceptable para la salud o el ambiente, y dentro de ese proceso pueden pedirse medidas cautelares que impliquen la suspensión en la importación, comercialización y uso de ese plaguicida, hasta que se anule su registro; de tal manera que los ambientalistas radicales que interpusieron sin éxito el recurso de amparo y la acción de inconstitucionalidad contra el decreto ejecutivo n.°39995-MAG del 15 de diciembre 2016 no pueden pretender que la Sala anule los registros sin demostrar y acreditar las evidencias científicas que demuestren la afectación o riesgo para la salud o el ambiente.

Reitera que los decretos solo son aplicables a IAGT y productos formulados viejos, es decir, aquellos de los que ya se otorgaron registros en el país y que se han utilizado por muchos años, uso que ha permitido conocer con certeza su comportamiento, seguridad y eficacia, todos son productos que ya tienen un registro y por tanto que se pueden comercializar por contar con un registro vigente, conforme a la normativa que estaba vigente al momento de ser otorgados. Los registros fueron inscritos porque cumplieron con los requisitos, procedimientos y evaluaciones que establecía esa normativa vigente, por lo cual esos productos están amparados a un registro y esa situación jurídica no puede ser obviada por la administración activa.

En cuanto a la aplicación del principio precautorio en materia de plaguicidas, invoca el dictamen de la PGR n.°C-255-2009 y establece que la competencia del Ministerio de Salud y el de Ambiente y Energía se mantienen, en particular respecto de la vida y la salud de las personas, e insiste en los temas de legalidad ya explicados. Reitera en que una vez que se registra un determinado producto, la Administración Pública crea una situación jurídica consolidada y que en todo caso pueden dictarse medidas cautelares o anulatorias, si se verifica alguna afectación a la vida o a la salud.

Apunta que el decreto ejecutivo n.°39995-MAG y su reforma n.°41481-MAG permite resolver los problemas de desorden, incertidumbre y falta de información en los expedientes que amparan las inscripciones de los IAGT y plaguicidas formulados con registro vigente, pero que fueron otorgados con una normativa distinta al decreto ejecutivo n.°33495-MAG-S-MINAE-MEIC. Estima que la normativa cuestionada es un gran avance y resuelve un problema que inició en el año 2004 y que aún no había sido resuelto por las anteriores administraciones, pues tiene previstas las alternativas y vías para resolver los dos problemas más graves que aquejan al sistema de registros de nuestro país: por un lado, la parálisis en registro de productos nuevos y genéricos y, por otro, la imposibilidad de renovar los registros de formulaciones que actualmente están en el mercado.

Establece que una de las virtudes del decreto ejecutivo en cuestión es que permite la aplicación del nuevo reglamento de registro de productos sanitarios, pues uniformó la vigencia de los registros y asoció las formulaciones a los fabricantes, en relación con decretos ejecutivos anteriores. En ese sentido detalla que la normativa impugnada permite: a) la actualización de los fabricantes, su origen, sitios de producción de los IAGT asociados a las formulaciones que ya se comercializan en Costa Rica y que fueron registrados con legislación distinta; b) lo mismo en relación con los plaguicidas formulados; c) acabar con la incertidumbre jurídica respecto de la vigencia de los registros IAGT y plaguicidas formulados que fueron registrados con legislación y normativa previa, uniformando el plazo de vigencia de diez años para todos los registros y acabando de este modo con la vigencia indefinida; equiparar los registros de las formulaciones viejas al sistema de registro actual al otorgarles el registro de IAGT con lo cual se logra eliminar las formulaciones que no cuenta con uno asociado debidamente actualizado y ordenar y actualizar las etiquetas y panfletos con los que se están comercializando los plaguicidas formulados en Costa Rica, de tal manera que a partir del reglamento todo cambio o modificación de etiqueta y panfleto quede registrado en el expediente físico del producto.

Reprocha que el accionante pretende entorpecer el proceso de actualización de expedientes y no aporta prueba documental o científica y considera que se echa de menos una enumeración de los derechos y garantías constitucionales conculcados. Insiste en que en los expedientes 17-005922-0007-CO y 17-002503-0007-CO se interpuso una acción de inconstitucionalidad y un recurso de amparo ‒respectivamente‒ en contra del decreto ejecutivo objeto de este proceso y que ambos fueron rechazados y destaca especialmente el razonamiento de la nota separada de la magistrada Hernández López a este respecto.

Cuestiona el argumento de la parte accionante respecto del proceso de actualización como proceso de reevaluación, pues indica que cualquiera de los productos que hoy cuentan con registro vigente pueden ser suspendidos o anulados si representan algún riesgo para la salud o el ambiente. Además, alega que el accionante omite decir que son productos, cuyo IAGT y el producto formulado asociado a este ya están en el mercado y no se trata de productos nuevos que requieran de una evaluación de previo a otorgarles un registro que les permita la comercialización, de tal manera que no lleva razón el accionante al hacer tales afirmaciones, y se cuestiona de dónde saca el accionante que el proceso de actualización es un proceso de reevaluación de riesgo de un producto que ya se comercializa en el mercado y que tiene un registro vigente.

Argumenta que los informes de la CGR que ha invocado la parte accionante han sido descontextualizados, y que se pretenden aplicar a una situación jurídica distinta. Indica que en el caso del informe de DFOE-AM-19-2004, se encontraba vigente el anterior decreto que regulaba la materia ‒a saber, el 24337-MAG-S de 1995‒, por lo que no resultan de aplicación las valoraciones realizadas por la CGR en aquel momento:

“Finalmente en los antecedentes la accionante hace cita de un informe de la Contraloría, sacando de contexto el mismo y pretendiendo aplicarlo a una situación jurídica absolutamente distinta y nos parece, que si bien es cierto no es un tema de constitucionalidad, vamos a hacer algunas aclaraciones respecto de dicho informe y su contextualización, el informe DFOE-AM-19-2004 del 20 de octubre de 2004, analiza lo que sucedía con el funcionamiento del registro y sus diferentes procesos en esa época, así como la normativa vigente en ese momento, en este caso el Reglamento para Registro, Uso y Control de Plaguicidas Agrícolas y Coadyuvantes, promulgado mediante Decreto Ejecutivo número: 24337-MAG-S del 27/04/95, no vigente desde el año 2007, se mantuvo en aplicación por casi doce años y trascendió incluso la derogatoria de la Ley que le dio origen, esto por cuanto su fundamento legal era la Ley de Sanidad Vegetal 6248 del 02/05/78 y no la Ley de Protección Fitosanitaria. Precisamente el Decreto Ejecutivo número: 24337-MAG-S del 27/04/95, que es el que estaba vigente al momento de que la Contraloría realizara la auditoría a los procesos de registro, no establecía una separación de los legajos de información e incluso no tenía previsto dentro del elenco de requisitos la presentación de la información química confidencial como tampoco tenía incorporada como modalidad de registro la determinación de equivalencia de IAGT, de ahí que no se hablaba durante la vigencia de dicho reglamento de registro ni de equivalencia, ni de perfil de referencia ni de información confidencial ni de protección de datos de prueba. En cuanto a la evaluación previa del impacto de los plaguicidas en la salud y el ambiente, el informe DFOE-AM-19-2004 del 20 de octubre de 2004, es claro en el sentido de que no se estaba haciendo de manera eficiente, lo cual era lógico pues el SFE, no contaba dentro de su estructura con las dependencias competentes para evaluar la información toxicológica y ecotoxicológica, que aportaban los registrantes y por ello determinó que dicha evaluación debería hacer el Ministerio de Salud y el Ministerio de Ambiente, respectivamente. También recomendó la Contraloría, en el informe en cuestión, que había que emitir un nuevo reglamento con el sustento de la Ley de Protección Fitosanitaria, toda vez que la ley que sustentaba el reglamento vigente en ese momento ya había sido derogada.

Un aspecto a destacar es que cuando se emite el informe DFOE-AM-19-2004 del 20 de octubre de 2004, FAO no había elaborado (lo hizo en el año 2006) el documento donde se había previsto el registro de IAGT cuando no existía perfil de referencia con información referenciada, en efecto, el documento FAO: AGENDA ITEM NÚMERO 12.3A. INTERNACIONAL CODE OF ON THE DISTRIBUTION AND USE OF PESTICIDAS: DRAFT GUIDELINES ON DATA REQUIREMENTS FOR THE REGISTRATION OF PESTICIDAS, que es de octubre del dos mil seis, dice lo siguiente: ‘De no existir productos técnicos registrados en el país con data completa, los ingredientes activos grado técnico que se pretenden registrar no lo pueden hacer por medio de equivalencia, sino por el procedimiento normal (…) Para productos para los cuales no se ha realizado una evaluación de riesgo completa en un país dado, debido a la carencia de datos y /o fallos por el o los registrantes originales para proveer el juego de datos completo requeridos para una evaluación de riesgo, cualquier ingrediente activo previamente registrado por el o los registrantes originales o registrantes posteriores, puede ser usado por las autoridades de registro de un país como una fuente de referencia para la evaluación de equivalencia, previendo que toda la información química requerida para el registro esté disponible, sin considerar que la evaluación de riesgo no está completa”. (El subrayado no corresponde al original).

Menciona, además, que dicho informe se emitió de manera previa a la promulgación de la ley n.°8622, que incorporó el Tratado de libre comercio República Dominicana, Centroamérica- Estados Unidos (CAFTA, por sus siglas en inglés) al ordenamiento jurídico costarricense. En esta misma línea, establece que para cuando se emitió dicho informe, la Organización de las Naciones Unidas para la Alimentación y la Agricultura (FAO, por sus siglas en inglés) no había promulgado el Manual sobre la Elaboración y Empleo de las Especificaciones de la FAO y de la OMS para Plaguicidas, el principio de no repetición de estudios, principio que se incorpora en el considerando XIII del decreto ejecutivo n.°40059-MAG-MINAE-S:

“En dicho principio la FAO y la OMS reconocen que la generación repetitiva de los estudios e información respecto de todos los riesgos potenciales/reales para cada fabricante de un plaguicida, puede ser innecesaria y éticamente no deseable, obviamente el informe número: DFOE-AM-19-2004 del 20 de octubre de 2004 de la Contraloría General de la República, fue emitido con anterioridad a la entrada en vigencia de los acuerdos internacionales en materia de protección de datos de prueba y antes de la incorporación del principio de no repetición de datos de prueba por parte de la FAO y la OMS. (…)

Este principio, es un principio fundamental en el proceso de registro, no solo porque plasma a nivel normativo una tesis, basada en la ciencia y en la química, que hemos sostenido históricamente la industria genérica, en el sentido de que la equivalencia química, entre dos IAGT, torna innecesario exigir estudios toxicológicos, ecotoxicológicos o de destino y comportamiento ambiental. Este principio general debe ser observado y acatado, por las autoridades nacionales, por ello los registrantes están facultados para invocar dicho principio al solicitar la exención de alguno de los ensayos o estudios que se establecen en el Reglamento de Registro, al respecto debemos recordar que las normas no escritas (costumbre, jurisprudencia y los principios generales de derecho), son útiles para la interpretación, aplicación e integración del ordenamiento escrito, de tal modo que en casos de insuficiencia o vacío normativo los principios generales constituyen una fuente de derecho”.

Refuta el ya citado informe n.°DFOE-AM-19-2004 de la CGR, al señalar que en el 2013 operó una reforma en el Código Internacional de Conducta para la Distribución y Utilización de Plaguicidas de la FAO, por lo que considera el informe inaplicable. Afirma que dicho Código promueve que los Estados establezcan un sistema de registro y control de plaguicidas y menciona el dictamen C-215-2013 de la PGR, el cual se refiere a esta norma internacional. Complementa lo anterior al indicar que un informe de la CGR no puede otorgar potestades de imperio relacionadas con el registro de plaguicidas a otros ministerios e insiste en que la competencia en materia de plaguicidas le corresponde al SFE, según la Ley de Protección Fitosanitaria. Dice que la reforma que operó el decreto ejecutivo n.°41481-MAG sobre el decreto ejecutivo n.°39995-MAG no permite registrar nuevos plaguicidas ‒nuevos, según el art. 15.10 del CAFTA‒ y que la reforma que opera se vincula con modificación de plazos y requisitos administrativos.

Insiste en que es el MAG, a través del SFE, el órgano competente para la recepción, verificación y evaluación de certificados de registro, como potestad de imperio originada en la Ley de Protección Fitosanitaria, con exclusión de la participación de otros órganos como el Ministerio de Salud y el MINAE:

“En el tanto que el SFE, ajuste su estructura y tenga dentro de la Unidad de registro las áreas de Evaluación Química, la de Evaluación Toxicológica y la de Evaluación Ecotoxicológica, no podría siquiera insinuarse que exista un deterioro en la normativa ambiental, pues como ya hemos explicado, fue el legislador el que en la Ley de Protección Fitosanitaria le confirió al MAG, a través del SFE, la competencia para crear y administrar el registro de plaguicidas de uso agrícola, por lo que este órgano desconcentrado deberá contar con una estructura técnica, organizativa y administrativa, que procure, no solo la calidad y eficacia de los plaguicidas, sino su seguridad, a efecto de que tanto el ambiente como la salud humana sean protegidos, garantizando que el uso de estas sustancias no representan riesgos inaceptables a la salud y el ambiente”.

Respecto del análisis que hace el accionante al articulado del decreto ejecutivo n.°41481-MAG del 10 de diciembre 2018, manifiesta lo siguiente:

Sobre el art. 1 Tal y como se observa dicho texto comparado con el texto sin reforma, mantiene su ámbito de aplicación en el sentido de que por esta normativa no se puede registrar nuevos plaguicidas (nuevos conforme al concepto del art. 15.10 del CAFTA y del art. 8 de la ley de Información no divulgada) y lo único que cambia es lo relacionado con los plazos, y uno de los requisitos administrativos. El accionante objeta el tema de plazos que, como reiteramos, es un tema de legalidad que debe dirimirse en otra sede y no en sede constitucional. Es importante dejar claro que es la autoridad competente la que determina cuáles son los plazos en los que deben realizar determinados actos y los plazos que tiene que cumplir el administrado para sus gestiones al amparo de la norma. También entra analizar el tema de los requisitos e incluso emite criterio sobre lo que según el accionante deben ser los requisitos, el procedimiento para evaluación de estos y cuáles autoridades deben intervenir en esos, lo cual resulta no solo inaceptable procesalmente sino que legalmente hay un esquema de competencias y expresamente en la ley n.°7664 confiere al MAG y al SFE. De la relación de los ordinales 23, 24, 25, siguientes y concordantes de la Ley de Protección Fitosanitaria, con el art. 11 constitucional y los numerales 11 y 59 de la LGAP, puede afirmarse que los procedimientos de recepción, verificación, evaluación y emisión de los certificados de registro, constituyen una potestad de imperio conferida por el legislador al MAG por medio del SFE. Por lo tanto, considera que en esta materia estaría vedado conferir potestades de imperio, mediante decreto, como también resultaría inaceptable desde una óptica estrictamente jurídica fundamentar en leyes generales relacionadas con el ambiente o la salud humana, un decreto ejecutivo, competencias para el Ministerio de Salud y MINAE, cuando ya el legislador, en una ley específica (Ley de Protección Fitosanitaria) dispone, no solo el órgano al que corresponde ejercer esas competencias, sino que por norma expresa (art. 23 de la Ley de Protección Fitosanitaria) establece que los requisitos para la inscripción de sustancias químicas, biológicas, bioquímicas, coadyuvantes y sustancias afines y equipos de aplicación de uso agrícola serán establecidos en el reglamento a la Ley de Protección Fitosanitaria, por lo que es claro que en aplicación de los principios de la hermenéutica jurídica, todas las normas, requisitos y procedimientos para la inscripción son los que contemplen en la reglamentación a esa esa ley.

Sobre el art. 2 El accionante se limita a objetar temas de mera legalidad y es omiso en cuanto a las alegadas inconstitucionalidades de la norma que objeta. Incluso de la lectura pura y simple del texto queda evidenciado que es falaz la afirmación de el accionante, en el sentido de que se estén otorgando registros a nuevos productos mediante esta normativa reglamentaria. Tampoco es cierto como lo afirma lo accionante que son agrónomos los que están a cargo de la revisión de la información química; pero, más allá de las inexactitudes y falacias en las que incurre el accionante, lo que queda evidenciado es que sus alegatos son sobre aspectos administrativos y de mera legalidad, que no corresponde dirimir a la Sala Constitucional sino a la jurisdicción ordinaria.

Sobre el art. 3 En cuanto a los aspectos relacionados con los plazos, con un “atrevimiento inaceptable”, hace referencia a las cargas de trabajo institucionales, olvidando que lo que está planteando y sometiendo a conocimiento de la Sala es una acción de inconstitucionalidad de una norma emitida mediante decreto ejecutivo. Así, viene a confirmar que estamos ante un cuestionamiento de aspectos administrativos y de mera legalidad por parte del accionante en una sede jurisdiccional que no le corresponde conocer de estas materias. Llama la atención sobre la mención que hace el accionante sobre un aspecto técnico que deja evidenciado su profundo desconocimiento en la materia regulada por el decreto impugnado y, por respeto a la ciencia y al sistema de registros, explica muy sucintamente:

“Como ya habíamos señalado en Costa Rica antes del 10 de enero del 2007 el sistema de registro establecía que se podía registrar una formulación sin necesidad de contar con un registro de la materia prima, es decir de su ingrediente activo grado técnico (IAGT), luego de esa fecha, se estableció que toda formulación de previo a ser registrada requería del registro de su IAGT, esto hace que en la actualidad un número enorme de alrededor de mil quinientos productos formulados no estén asociados a un fabricante, por eso es que en el Decreto Ejecutivo N° 39995-MAG del 15 de diciembre 2016 y su reforma (Decreto Ejecutivo N° 41481-MAG del 10 de diciembre 2018, publicado el 11 de enero del 2019, alcance número 8 del Diario Oficial La Gaceta), se establece un proceso de actualización que permitirá al sistema de registros garantizar que toda formulación que se comercialice en el país, estará asociada a un fabricante del IAGT, de tal manera que esa actualización del fabricante no implica que se esté otorgando el registro a un producto nuevo sino que mediante este proceso de actualización la autoridad contará con la información necesaria para determinar si el material técnico con el que se formula ese producto formulado no contiene impurezas relevantes y que además cumple con la especificación internacional que debe cumplir todo IAGT para la formulación de plaguicidas, de modo que es incorrecto lo que indica la accionante en cuanto a la falta de fundamento técnico o científico y a la confusión que hace con el registro bajo la modalidad de equivalencia por cuanto el proceso lo que plantea no es una equivalencia sino una actualización de la información de un registro vigente de un producto formulado que no cuenta con un fabricante de IAGT asociado a su registro, recordando que en virtud del artículo 3 no es que se esté autorizando un producto nuevo sino que es asociando un fabricante a esa formulación que ya cuenta con registro y que se comercializa en el país”.

El desconocimiento técnico y científico del accionante en la materia lo lleva a asimilar el proceso de actualización que establece el decreto ejecutivo n.°39995- y su reforma n.°41481-MAG, con la modalidad de registro por equivalencia que se establece en el Reglamento Técnico de Registro (decreto n.°40059-MAG-MINAE-S). Además, la organización accionante olvida que en Costa Rica la modalidad de registro por equivalencia es sobre la base de equivalencia química, por lo que no se requiere de la información técnica, tal y como lo establecen los sistemas de registro por equivalencia promovido por FAO.

Sobre el art. 5 Al hacer el análisis del art. 5, el accionante confunde el concepto de fabricante con el de formulador, de tal manera que toda la hipótesis, objeciones y análisis que hace de dicha norma no es aplicable a la situación jurídica que regula la actualización de formuladores del decreto ejecutivo n.°39995-MAG del 15 de diciembre 2016 y su reforma n.°41481-MAG.

Sobre el art. 6 El art. 6 del decreto impugnado garantiza en su redacción actual, primero, que Costa Rica dejará de contar con registros a plazo indefinido, sino que a partir de la actualización, todos los registros de IAGT y producto formulados tendrán una vigencia de 10 años imponiendo la obligación de renovarlos. No será como ahora, que al ser a plazo indefinido no deben ser renovados por no contar con fecha de expiración; segundo, que se garantizará que todas las formulaciones que se venden en el mercado actualmente contarán con un fabricante asociado, y no como ahora, que no se tiene conocimiento de los sitios y orígenes de fabricación de las materias primas; tercero, que todo IAGT que se utilice en el país para la formulación de productos autorizados para comercializarse aquí tiene acreditado su pureza y que no tiene impurezas relevantes por encima de la especificación internacional; cuarto, que todos los IAGT que se utilizan en Costa Rica cumplen con los convenios internacionales suscritos por Costa Rica (Anexo III del Convenio de Rotterdam, en el Convenio de Estocolmo, o en el Protocolo de Montreal); y quinto, que el SFE creará una base de datos de información toxicológica, ecotoxicológica y de destino ambiental de los ingredientes activos grado técnico que se encuentran registrados y que no cuentan con plazos vigentes de protección de datos de prueba. Es muy importante que el SFE cuente con un banco de información para las moléculas que no son nuevas y cuyos datos de prueba están libres de uso por no contar con plazos vigentes de protección. Es necesario que las empresas que tengan información toxicológica, ecotoxicológica y de destino ambiental de los ingredientes activos grado técnico, que no son nuevos, aporten información que han logrado recopilar y que sirva para que en futuro el SFE pueda ir conformando un perfil completo toxicológico, ecotoxicológico y de destino y comportamiento ambiental, completo, que permita tener un perfil de referencia para los registros por equivalencia.

Sobre el art. 7 El texto actual no guarda ninguna relación ni congruencia con los comentarios y afirmaciones temerarias que hace el accionante sobre este artículo específico. Respecto de la afirmación de que esta norma invierte el principio de la carga de la prueba o el principio precautorio, se rechaza “de manera absoluta y categórica”, no solo porque se trata de un tema de legalidad a discutir en la jurisdicción ordinaria, sino que el texto actual del art. 7 tiene sustento en reiterados dictámenes de la PGR y en sentencias de la Sala Constitucional. Considera que es incorrecto y temerario sostener, como lo hace el accionante, que el decreto cuestionado transgreda el principio precautorio en materia ambiental, como también es incorrecto indicar que se invierte la carga de la prueba.

Señala que la norma objeto de acción no permite o posibilita otorgar registros para nuevos productos a los que ya se comercializan en el mercado, esto por cuanto su ámbito de aplicación es muy claro y solo es factible aplicarlo a registros vigentes que hayan sido otorgados al amparo de regulaciones (legales o reglamentarias) diferentes al decreto ejecutivo n.°3495-MAG-SMINAE-MEIC y sus reformas. Es decir, “no es factible registrar IAGT nuevos nuevas formulaciones con IAGT nuevos”, y los IAGT que se otorgan, necesaria e indefectiblemente. Con esta normativa no se otorgarán registros de IAGT y mucho menos de formulaciones que no se encuentren ya en el mercado. Respecto de los agroquímicos registrados y que se comercializan actualmente en el país, no existe ningún peligro adicional o resultante de la aplicación del mismo, en cuanto a la salud humana, el ambiente o la eficacia biológica del plaguicida. Por tanto, no es correcto afirmar que con la aplicación del decreto, los registros que se actualicen en sus expedientes, supongan un riesgo adicional para la salud, el ambiente o la agricultura, pues todos, absolutamente todos los registros de IAGT que se otorguen, necesaria e indefectiblemente, deben corresponder a alguna de las formulaciones que ya se venden en el mercado y sobre estas formulaciones, los Ministerios de Salud o Ambiente tienen amplias e indiscutibles competencias y facultades para adoptar las medidas pertinentes para evitar un daño a la salud o al ambiente, no solo acudiendo a la vía jurisdiccional a anular los actos administrativos bajo los cuales se les otorgó el registro, sino incluso impidiendo precautoria o cautelarmente todo acto que implique o conlleve la importación, fabricación, manipulación, almacenaje, transporte, comercialización, suministro y el uso y aplicación del producto que se considera que daña la salud o el ambiente. Con certeza, la normativa impugnada solo es aplicable a productos a los cuales ya se le otorgó un registro y por tanto que se pueden comercializar. Todos esos productos, a los que se les aplica el decreto en análisis, fueron inscritos porque cumplieron con los requisitos, procedimientos y evaluaciones que establecía la normativa vigente al momento de otorgarse su registro, por lo cual esos productos están amparados a un registro y esa situación jurídica registral no puede ser obviada por la Administración activa. Al respecto, ya la PGR fue clara y contundente en el dictamen número C-255-2009 al afirmar que los registros de plaguicidas (IAGT o formulados) que actualmente cuentan con registro vigente están habilitados, por tanto, para ser comercializados en el país. Lo expuesto deja acreditado que no existe la violación del principio precautorio en materia ambiental, ni tampoco se está invirtiendo el principio de la carga de la prueba, toda vez que por tratarse de productos que se comercializan, amparados a un registro, esto implica que ya ese producto cumplió con los requisitos y procedimientos que establecía la normativa vigente y además fue evaluado conforme a esa normativa por las autoridades competentes. Por tanto, es claro e indiscutible que la Administración activa debe respetar esa situación jurídica y derecho del administrado, por lo que, para anular el acto que confirió el mismo, debe seguir los procedimientos que fija el Código Procesal Contencioso-Administrativo, tendientes a declarar la lesividad y anulación del acto de registro, pudiendo, incluso, como medida precautoria impedirse, mientras se declara la lesividad, la importación, fabricación, manipulación, almacenaje, transporte, comercialización, suministro y el uso y aplicación del producto que se considera que daña la salud o el ambiente.

Sobre el art. 11 El accionante no aporta más que una transcripción de partes de un informe del ente contralor absolutamente descontextualizado y no aplicable a la situación concreta. La homologación de formulaciones planteada en el art. 11 del decreto impugnado está basado en el manual de especificaciones de la FAO y la Organización Mundial de la Salud (OMS), para la elaboración de especificaciones de plaguicidas.

Posterior al anterior análisis particular de las normas impugnadas, reitera la atribución competencial en materia de registro de sustancias agroquímicas que diversas normas legales y reglamentarias asignan al MAG a través del SFE y, en este sentido, aporta transcripciones de dictámenes de la PGR y sentencias de la Sala Primera de la Corte Suprema de Justicia.

Respecto de las conclusiones del accionante La normativa bajo examen aplica solo a productos viejos, es decir, productos de los cuales ya se ha otorgado registros de IAGT o de formulado, y muchos de esos registros se otorgaron a plazo indefinido. Esto quiere decir que no requieren del decreto de actualización para seguir comercializando, por ello más que facilitar, se trata de imponerles una obligación para que actualicen su información y aporten datos y estudios que acrediten no solo la procedencia y origen de los materiales técnicos y de las formulaciones asociadas, sino que aporten la información química confidencial que permita a la autoridad de registro, sea al SFE, tener a disposición la información química confidencial sobre pureza, impurezas, método de síntesis, etc. de sus materiales técnicos, tanto en cuanto a los fabricantes como a los formuladores. Esa información química confidencial demuestra si el IAGT tiene impurezas de relevancia toxicológica o ecotoxicológica que puedan tener efecto en la salud o el ambiente. Esa información hoy no se tiene en los registros que deben actualizarse.

Dependiendo de las impurezas relevantes y de su concentración, la autoridad de registro puede tomar decisiones regulatorias respecto de la continuidad o no de un registro o de un fabricante de un material técnico de una formulación que se comercialice en Costa Rica.

El accionante sostiene o deja entrever sin sustentarlo, que todo fabricante de IAGT debe aportar sus propios datos de prueba, es decir, que cada fabricante realice estudios de toxicológicos crónicos, subcrónicos, ecotoxicológicos y de destino y comportamiento ambiental. Así, pretende que a los fabricantes de IAGT utilizados en la formulación de plaguicidas se les obligue a realizar estos estudios (no explica el accionante porqué a los fabricantes de principios activos utilizados en medicamentos humanos no se les pide esto mismo). Esa pretensión esboza el accionante es absolutamente censurable por FAO y la OMS, pues ambos organismos internacionales en el Manual sobre la Elaboración y Empleo de las Especificaciones de la FAO y de la OMS para Plaguicidas, han incorporado el principio de no repetición de estudios, principio que se incorpora en el considerando XIII del decreto ejecutivo n.°40059-MAG-MINAE-S.

Tampoco es cierto que los materiales técnicos y los productos formulados registrados nunca hayan sido evaluados, como temerariamente afirma en sus conclusiones el accionante; todos los productos registrados fueron inscritos luego de verificar que cumplían con los requisitos que establecía la normativa vigente y no podría, como pretende el accionante, venir el MAG y el SFE a desconocer esta situación jurídica y los derechos de los administrados.

La fundamentación técnica, filosófica y jurídica tanto del decreto ejecutivo n.°39995-MAG como de su reforma n.°41481-MAG del 10 de diciembre 2018, se encuentra en la parte considerativa y legal de ambas normas. En este caso la Ley de Protección Fitosanitaria n.°7664 que tiene como objeto regular el uso y manejo de sustancias químicas, biológicas o afines y equipos para aplicarlas en la agricultura; asimismo, su registro, importación, calidad y residuos, procurando al mismo tiempo proteger la salud humana y el ambiente, todas las que deberán inscribirse en el registro que el SFE creará para disponer de información sobre las características de estos y velar por su correcta utilización en el país.

Resulta esencial garantizar el abastecimiento y la continuidad en la comercialización de los productos que actualmente cuentan con registro vigente, siendo necesario actualizar la información en sus expedientes sobre las características de estos y velar por su correcta utilización en el país. El mismo decreto indica en sus considerandos que las reglamentaciones anteriores a la vigencia del decreto ejecutivo n.°33495 MAG-S-MINAE-MEIC del 31 de octubre de 2006 y sus reformas permitían al MAG otorgar los registros a plazo indefinido así corno la inscripción de los plaguicidas formulados sin que fuese requisito contar con registro previo del IAGT, lo que obliga al Poder Ejecutivo, dentro de sus facultades constitucionales y legales, organizar su registro, ordenando la actualización de la información de los registros inscritos a plazo indefinido, al haber sido otorgados con una normativa anterior.

Las normas cuestionadas pretenden actualizar los expedientes con la información que al momento de su registro no se solicitó, mediante un proceso de re registro acorde al art. 50 Constitucional.

La importancia del decreto ejecutivo n.°39995-MAG como de su reforma, decreto ejecutivo n.° 41481-MAG Desde el punto de vista técnico y científico: Permite al Estado contar con toda la información sobre pureza, impurezas relevantes (nombre, contenido y niveles de detección), impurezas totales, método de síntesis, metodologías analíticas para determinar el IAGT y sus impurezas relevantes, de todos los IAGT registrados como tales o como componentes de una formulación, que fueron registrados en Costa Rica con legislación y normativa distinta al decreto ejecutivo n.°33495-MAG-S-MEIC-MINAET. La información química confidencial que requiere este decreto es clave y esencial desde el punto de vista agronómico, toxicológico y ecotoxicológico, y lamentablemente no está incorporada a los expedientes de estos registros. Mucha de la información química que se solicita en el decreto, en especial, la descrita en los arts. 1 y 5, si bien se presentó durante el proceso de reválida, se encuentra totalmente desactualizada, pues han transcurrido entre 5 y 10 años desde que se aportó la información y las autoridades aún no han revisado y mucho menos aprobado. Permite al Estado costarricense contar con la información actualizada sobre los sitios y orígenes de formulación, nombre y ubicación física de los formuladores, así como los componentes del producto y la descripción detallada de los procesos de formulación de todos los productos formulados que se comercializan actualmente en Costa Rica.

Desde el punto de vista químico y científico: Garantiza que ningún plaguicida formulado, que se comercialice en Costa Rica, pueda estar registrado y por ende comercializado si no cuenta con un IAGT asociado que tenga niveles de impurezas relevantes (que son las que tienen importancia toxicológica y ecotoxicológica) superiores a los niveles especificados en los estándares internacionales de referencia (FAO, EPSA, IUPAC).

Desde el punto de vista jurídico: Logra equiparar los registros viejos (los que no fueron registrados al amparo del decreto ejecutivo n.°33495-MAG-S-MEIC-MINAET) con los registros que se otorguen bajo el sistema de registro (que establece como requisito previo para el registro de una formulación el registro del IAGT), con lo cual todas las formulaciones registradas actualmente tendrán su correspondiente IAGT asociado (con su fabricante actual, su origen y sitio de producción o síntesis), debidamente registrado. La información del legajo técnico es absolutamente congruente, no solo con el principio de no repetición de estudios que promueve FAO y la OMS, sino con la doctrina y derecho comparado. Otorga seguridad jurídica a los registrantes y productores agrícolas en cuanto al abastecimiento de los formulados que hoy se comercializan. Constituye el instrumento jurídico que permite la aplicación del nuevo reglamento de registro, al uniformar la vigencia de los registros y al asociar las formulaciones al fabricante actual de su IAGT y al formulador actual (nacional o extranjero) del producto.

Desde el punto de vista político: Otra de las novedades y beneficios del reglamento para la actualización de expedientes es que permitirá resolver un problema que las pasadas administraciones no han logrado solucionar, pese a que se intentó hacerlo mediante transitorios decretos (cambio de fabricante) y procesos de reválida. En Costa Rica un altísimo porcentaje (quizás un 80% u 85%) de las formulaciones que se comercializan en el mercado, no tienen asociado a su registro el respectivo IAGT, lo cual no solo deja en un estado de vulnerabilidad la protección a la salud y al ambiente, sino que no permite a los registrantes mejorar sus formulaciones o registrar nuevas. Esto queda superado con el nuevo reglamento. Ahora, con este decreto, se soluciona el problema de las formulaciones que no cuentan con un registro de IAGT asociado, por lo que tiene gran mérito la actual administración, pues el reglamento de actualización de expedientes de registro constituye un instrumento jurídico de un alto valor político. Resuelve el problema y la incertidumbre (técnica y jurídica), en la que se encuentran los registros que habían sido otorgados con normativas de diverso rango, diferentes a la que establecía el decreto ejecutivo n.°33495-MAG-S-MEIC-MINAET. Mediante este nuevo decreto se faculta y dispone los mecanismos para que la autoridad cuente con información técnica y química, que garantice que los plaguicidas que se comercializan actualmente no representen riesgo inaceptable para la agricultura la salud o el ambiente.

Desde el punto de vista agronómico: Ordena y actualiza las etiquetas y panfletos con los que se comercializan las formulaciones en Costa Rica, de tal manera que los factores que intervienen en el uso de un plaguicida formulado, a saber, la concentración del ingrediente activo grado técnico en la formulación, las dosis de aplicación, el período y el número de tratamientos, el uso de coadyuvantes y los métodos y lugares de aplicación que determinan la cantidad aplicada, la periodicidad del tratamiento y el intervalo previo a la cosecha, así como todos los factores inherentes a la modalidad de uso de un plaguicida formulado. Todo esto es un fiel reflejo del expediente del producto.

Solicita que se declare sin lugar el recurso.

4.- Los edictos a que se refiere el párrafo segundo del art. 81 de la Ley de la Jurisdicción Constitucional (LJC) fueron publicados en los números 84, 85 y 86 del Boletín Judicial, de los días 08, 09 y 10 de mayo de 2019.

5.- Por escrito recibido a las 10:05 hrs. del día 10 de mayo de 2019, se apersonó Julio Alberto Jurado Fernández a contestar la audiencia conferida a la PGR, y manifestó lo siguiente:

Sobre la legitimación La parte se encuentra legitimada para la interposición de la acción de inconstitucionalidad, pues se apersona en la defensa de intereses difusos, relacionados con los arts. 21 y 50 de la Constitución Política.

Sobre el fondo El objeto de este proceso constitucional guarda una estrecha relación con otro similar, que se tramita bajo el expediente 18-19039-0007-CO, por lo que se sugiere la acumulación de este proceso al anteriormente indicado.

Antes de que se emitiera el decreto ejecutivo n.°33495 de 2006, para registrar un plaguicida formulado no era necesario registrar previamente los ingredientes activos grado técnico requeridos para esa formulación y los registros se otorgaban sin plazo definido, ni tampoco se exigían los mismos requisitos técnicos. A raíz de lo anterior, el decreto ejecutivo n.°33495 estableció un proceso de reválida, para que los titulares de los registros de IAGT, otorgados antes de la promulgación de dicho reglamento, aportaran al SFE información necesaria para efectos de sostener la vigencia de sus registros. Posteriormente, se promulgó la ley n.°8702, que estableció un proceso de reválida similar al decreto anteriormente mencionado y el decreto ejecutivo n.°33495 fue derogado con la emisión del decreto ejecutivo n.°40059 ‒objeto de otra acción de inconstitucionalidad, tramitada en el expediente 18-009107-0007-CO‒. De manera posterior, se emitió el decreto ejecutivo n.°39995, que estableció otro proceso de reválida para el registro de plaguicidas, sujeto a un plazo. Antes de que este plazo acaeciera, se emitió el decreto ejecutivo n.°41841 ‒objeto de la presente acción de inconstitucionalidad‒ que amplió el plazo de reválida a sesenta meses a partir de su publicación. En los considerandos de dicho decreto se explica que el SFE suspendió la aplicación del decreto ejecutivo n.°39995 ante una consulta de la auditoría del SFE a la PGR y que “por falta de procedimiento no se ha logrado actualizar la información de ninguno de los registros de los ingredientes activos grado técnico (IAGT) y de los productos formulados que no cuentan con registro de IAGT y que no fueron inscritos conforme al decreto ejecutivo n.°33495”. Además de modificar el plazo dispuesto en el art.1° del decreto ejecutivo No. 39995 se varían algunos requisitos y aspectos de procedimientos de dicho decreto, al parecer con fundamento en el considerando sexto en el que se dispuso:

“Que los ingredientes activos grado técnico son utilizados únicamente para la formulación de plaguicidas químicos sintéticos formulados y que solo por excepción son utilizados directamente en el campo y estas situaciones de excepción ya se encuentran reguladas en la normativa técnica vigente; por ello los certificados de registro de ingredientes activos grado técnico únicamente tiene utilidad para autorizar, por parte del Servicio Fitosanitario del Estado, a la importación de estos como materia prima de formulaciones de plaguicidas en plantas de proceso y no para su uso directo en campo”.

Sobre el análisis de constitucionalidad de la norma impugnada Tal y como se dijo en el informe a la acción n.°18-19039-0007-CO, la Procuraduría no es competente para valorar aspectos estrictamente técnicos y determinar si los requisitos e información que la norma impugnada enlista son adecuados o no para llevar una correcta valoración del riesgo ambiental y sanitario de los plaguicidas, por lo que, en ese aspecto, el análisis de constitucionalidad debe tomar en cuenta la información técnica que se haga llegar al expediente.

En el informe a la acción n.°18-19039-0007-CO, la Procuraduría señaló que en el proceso de reválida del decreto n.°33495 se exigían ciertos requisitos técnicos que no fueron contemplados por el decreto n.°39995, pese a que en los considerandos de este último se reconoce que se trata de la actualización de productos que no han cumplido con los requisitos de información toxicológica, ecotoxicológica y de destino ambiental dispuestos en normativa internacional y exigidos a partir de la entrada en vigencia del decreto n.°33495. Por tanto, con base en lo anterior, se indicó que, si los informes técnicos que se hicieren llegar al expediente confirman lo anterior y de ellos se desprende que no existen criterios técnicos que justifiquen el contenido de la norma y que determinen que con los requisitos exigidos no es posible llevar a cabo una adecuada valoración del riesgo ambiental y sanitario, se estaría violando el principio de no regresión ambiental y el principio de objetivación de la tutela ambiental, porque se estarían disminuyendo los niveles de protección ambiental y sanitarios que disponía el decreto n.°33495, sin un estudio que respalde la adopción de esa medida. Además, se sostuvo que se estaría infringiendo el principio preventivo, pues, al no exigirse información que permita realizar una adecuada valoración del riesgo ambiental y sanitario de los productos, no es posible adoptar medidas destinadas a evitar, mitigar o corregir los efectos adversos que los plaguicidas generan al ambiente. Y que, incluso, ello implicaría una violación al principio precautorio, puesto que, sin una adecuada revisión del riesgo sanitario y ambiental de los plaguicidas, no existiría certeza científica de que éstos no producen afectaciones al ambiente.

En este caso, en primer término debe valorarse cuál es el fundamento técnico del decreto n.°41481 que motivó la ampliación del plazo de reválida por cinco años más y que justifica la posibilidad de seguir comercializando plaguicidas, pese a que no se han ajustado al proceso de reválida y sus efectos sobre la salud y el ambiente no han sido determinados.

La formulación de una consulta a la Procuraduría, contrario a lo indicado en los considerandos del decreto, no suspende la aplicación de las normas que son objeto de la consulta. Y, por tanto, la consulta planteada por el auditor interno del SFE con respecto a varias interrogantes relacionadas con los decretos números 39461, 40059 y 39995-MAG y que dio origen al dictamen n.°C-199-2017, no implicaba la suspensión del proceso de reválida que establecía el decreto n.°39995.

Asimismo, debe valorarse técnicamente si los requisitos dispuestos por la norma impugnada para el proceso de reválida permiten realizar una adecuada valoración del riesgo ambiental o sanitario de los productos, pues, de la mera comparación de los textos del decreto n.°39995 y del decreto n.°41841 se constata que no se añadieron los requisitos técnicos que sí contemplaba el decreto n.°33495, sino que, más bien, se eliminaron y modificaron algunos puntos.

Por ejemplo, en el art. 1° se sigue sin exigir los estudios de toxicidad aguda y los estudios de ecotoxicidad que contemplaba el decreto n.°33495, y estos son requeridos únicamente para los casos en los que haya cambiado el fabricante y el producto presente impurezas relevantes, lo cual se determina según especificaciones y estándares internacionales de referencia. Además, en el art. 1.1 se eliminó la solicitud para actualización de fabricante, el certificado de registro expedido por la autoridad del país de origen y el refrendo de un químico para el certificado de composición cuali-cuantitativa. En el art. 1.2 se eliminó el certificado de registro expedido por la autoridad del país de origen y se varió la forma de indicar el nombre químico en el certificado analítico de composición de ingrediente activo; y en el art. 5° se eliminó el certificado de país de origen y el refrendo químico del certificado de composición cuali-cuantitativa y del certificado de análisis del producto formulado y se mantiene la posibilidad de acreditar mediante una declaración jurada del titular del registro, que no ha variado la composición de la formulación y que se utiliza un ingrediente activo autorizado.

Con sujeción a lo que se disponga en los criterios técnicos que se remitan, si se confirma que la norma impugnada carece de fundamento técnico y que flexibiliza los requisitos y amplía el plazo del proceso de reválida, impidiendo una correcta evaluación de los efectos de los plaguicidas y permitiendo su comercialización en esos términos, la Procuraduría estima que la acción de inconstitucionalidad debe ser declarada con lugar. Salvo que, como se recomendó en el expediente n.°18-19039-0007-CO, la Sala estime que el decreto impugnado no enerva las facultades del SFE para requerir cualquier otra información pertinente y necesaria para realizar una adecuada evaluación que permita determinar que el uso del producto no afecta la salud ni el ambiente, tal y como se ha indicado en otras ocasiones.

En ese mismo sentido, debe declararse la inconstitucionalidad del art. 2° si, con base en los criterios técnicos que se hagan llegar al expediente, se determina que la reducción del plazo de tres meses a un mes, para que el SFE verifique y analice la información presentada y resuelva la solicitud de actualización del producto y otorgue el certificado de registro, impide que se efectúe una adecuada valoración del riesgo ambiental y sanitario del producto. Sin perjuicio de lo que se resuelva sobre ese artículo, es conveniente que la Sala Constitucional aclare si resulta aplicable la regla de que la figura del silencio positivo no opera en el caso de las aprobaciones o autorizaciones ambientales y que, por tanto, el incumplimiento del plazo dispuesto por parte de la Administración no implicaría la aprobación automática de la reválida del producto.

Sobre la posibilidad de registrar productos utilizando información referenciada, la Procuraduría en el informe rendido en el expediente n.°18-19039-0007-CO estimó que en caso de confirmarse que no existe respaldo técnico y que con el tipo de información requerida no es posible llevar a cabo una adecuada valoración del riesgo ambiental y sanitario, los artículos que contemplan esa posibilidad, resultarían inconstitucionales, por violar los principios de objetivación de la tutela ambiental, preventivo y precautorio.

Además se señaló el voto n.°16937-2011 que declaró inconstitucional el inciso b) y la referencia en el párrafo penúltimo a dicho inciso b) del apartado 7.3.2 del art. 2 del decreto ejecutivo n.°33495, en cuanto permitía el registro por equivalencia de productos ingrediente activo grado técnico utilizando como perfil de referencia otros registros que no contaban con información completa, pues para la inscripción de estos últimos no se exigían, además de los estudios de toxicidad aguda y ecotoxicidad, estudios adicionales de toxicología crónica, estudios ecotoxicológicos y otros estudios sobre el medio abiótico como lo exige el art. 5° de la Ley para la Importación y Control de la Calidad de Agroquímicos y el Manual sobre Desarrollo y Empleo de las Especificaciones de la FAO y de la OMS para Plaguicidas (que resulta de aplicación según lo dispuesto por el art. 44 de la Ley de Protección Fitosanitaria y el art. 6.1.7 del Código Internacional de Conducta para la Distribución y Utilización de Plaguicidas de la FAO).

Con base en lo anterior, si bien la Procuraduría no es un órgano técnico en la materia, sí puede indicarse que aunque el decreto impugnado modifica los arts. 1.2.b y 6 del decreto n.°39995 que permitían registrar productos mediante información referenciada, mantiene esa posibilidad, pues en el art. 1.2.c permite el uso de especificaciones internacionales para acreditar que el material técnico que se pretende actualizar no cuenta con impurezas relevantes, indicando en el considerando quinto que las especificaciones y estándares internacionales son una referencia técnica y científica para determinar que los ingredientes activos grado técnico no contienen impurezas relevantes en niveles superiores a los estándares o especificaciones internacionales, y que solo esas impurezas relevantes son las que tienen relevancia toxicológica o ecotoxicológica que pueden causar una afectación a la salud o al ambiente.

En ese mismo sentido, en el art. 3° dispone que a los plaguicidas formulados que no cuenten con un registro de ingrediente activo grado técnico asociado, se le otorgará ese registro de manera directa cuando el fabricante de ese ingrediente activo haya sido actualizado.

El art. 6° dispone que cumplidos los requisitos se otorgará el registro por 10 años y que, durante ese plazo, el SFE verificará que los registros ya aprobados de ingrediente activo grado técnico tienen equivalencia química con el perfil de referencia de ese ingrediente activo y que, en ausencia de ese perfil, debe verificarse que no contienen impurezas relevantes.

El art. 11 avala la homologación de etiquetas y panfletos con los de otros productos ya registrados que tengan el mismo ingrediente activo e igual concentración, sin contemplarse los efectos que podrían tener los demás componentes del producto o la forma o método de elaboración.

En la norma impugnada no se establece de qué manera será verificable la información, cómo determinar cuál especificación internacional puede ser utilizada, la forma de determinar la equivalencia de productos, ni si el perfil de referencia a utilizar debe ser un registro que cuente con información completa y, por tanto, que abarque los estudios de toxicidad aguda, ecotoxicidad, toxicología crónica, ecotoxicológicos y otros estudios sobre el medio abiótico como lo exige el art. 5 de la Ley para la Importación y Control de la Calidad de Agroquímicos y el Manual sobre Desarrollo y Empleo de las Especificaciones de la FAO y de la OMS para Plaguicidas.

Al no establecerse con precisión las reglas a las que la autoridad competente debe ajustarse para verificar la información, es posible que se permita la actualización de registros con información referenciada que no cumple con los requisitos indicados, y, por tanto, ello implicaría la actualización de registros de productos sin una evaluación previa acerca de los riesgos ambientales y sanitarios de su aplicación.

De constatarse lo anterior, según los criterios técnicos que se emitan al efecto, ello implicaría la inconstitucionalidad de los artículos que permiten el uso de información referenciada sin una adecuada determinación de equivalencia.

Sobre la exclusión del MINAE y el Ministerio de Salud del proceso de actualización de los registros, la Procuraduría indicó que el proceso de reválida que regulaba el decreto n.°33495 disponía que las instituciones competentes podían requerir información adicional y que ello hace suponer que se incluía la participación de esos Ministerios. Por tanto, se consideró que la no participación de los departamentos técnicos correspondientes de esas carteras en el proceso que establece el decreto n.°39995 implica un retroceso en el nivel de protección y una violación al principio de objetivación de la tutela ambiental, pues se permitiría la actualización de registros sin contar con el criterio técnico de esas dependencias dentro del campo de su competencia.

Lo mismo debe decirse del decreto impugnado, en el tanto arrastra ese mismo vicio al no incluir la participación de esos Ministerios, salvo que la Sala estime que las competencias atribuidas a otros órganos en sus respectivas leyes de creación, no quedan derogadas ni modificadas por la norma impugnada y que el SFE, dentro del ejercicio de sus competencias legales, puede y debe requerir la participación de cualquier organismo técnico especializado para verificar que un plaguicida no atente contra la salud y el ambiente.

Sobre la indebida inversión de la carga de la prueba que a juicio del accionante contempla el art. 7 reformado, la Procuraduría reitera que ello no enerva el deber constitucional que, en virtud del principio precautorio, tienen las autoridades competentes de aplicar las potestades dispuestas en los arts. 25 y 30 de la Ley de Protección Fitosanitaria y el 5° de la Ley para la Importación y Control de la Calidad de Agroquímicos, de “denegar, suspender o cancelar el registro de sustancias químicas, biológicas o afines”, “restringir o prohibir la importación, el tránsito, el redestino, la fabricación, la formulación, el reenvase, el reempaque, el almacenamiento, la venta, la mezcla y la utilización de sustancias químicas, biológicas o afines y equipos de aplicación para uso agrícola, cuando se justifique por razones técnicas” y de “prohibir la circulación u ordenar la destrucción de los productos que no cumplan con las normas de calidad, así como tomar otras medidas tendentes a mejorar la calidad de los agroquímicos”.

En conclusión: El análisis de esta acción de inconstitucionalidad implica valorar si los vicios que se le achacaron al decreto n.°39995 en la acción de inconstitucionalidad n.°18-19039-0007-CO han sido subsanados en el decreto impugnado, o si, por el contrario, se mantienen o se agravan.

6.- Por escrito recibido en esta Sala Constitucional a las 18:42 hrs. del 20 de mayo de 2019, el señor Jaime Enrique García González, doctor en ciencias agrícolas y catedrático del Área de Agricultura y Ambiente del Centro de Educación Ambiental de la Universidad Estatal a Distancia, especialista en plaguicidas, interpone coadyuvancia en este proceso. Procede a proponer prueba documental, que consiste en la resolución 153-2014-VI del Tribunal Contencioso Administrativo, así como la resolución 1030-2018 de la Sala Primera de la Corte Suprema de Justicia.

7.- Mediante escrito recibido a las 11:04 hrs. del 29 de mayo de 2019, el señor Jorge Arturo Osborne Escalante, cédula de identidad no. 1-0417-1413, en su condición de representante legal de la Asociación Cámara Nacional de Bananeros (“CANABA”, en adelante), con cédula de persona jurídica n.°3-002-056468, procede a apersonarse a este proceso como coadyuvante pasivo. En cuanto a su legitimación, aduce que deriva del objeto de CANABA, que es la defensa de los intereses de los asociados, vinculada con la actividad bananera en el país. Considera que le asiste un interés legítimo, derivado de la utilización de plaguicidas para controlar plagas y enfermedades en el cultivo y comercialización del banano. Alega que los asociados dicha asociación utilizan plaguicidas registrados como parte de su actividad comercial y que ello les permite mantener su productividad y sus exportaciones, de allí que considera que le asiste interés legítimo suficiente para asistir en calidad de coadyuvante pasivo en este proceso. Por otro lado, estima que al accionante no le asiste legitimación activa, toda vez que no señala en qué le afecta el decreto ejecutivo n.°41481-MAG e indica que en la certificación de personería aportada no se verifica la fecha de emisión, por lo que considera no debió haberse admitido. Respecto de lo que el accionante denomina objetivo de la acción, dice el representante legal de CANABA que el escrito contiene una serie de alegatos que carecen de fundamento. Sostiene que ahora se impone una obligación de actualización de la información y de aportación de datos y estudios referentes a los materiales técnicos y las formulaciones realizadas, así como la entrega de información confidencial al SFE. Con ello, coincide parcialmente con el informe MAG, en el sentido de que es la ley la que impone la emisión del decreto ejecutivo en cuestión, para el establecimiento de requisitos y procedimientos para la inscripción de sustancias químicas, biológicas y bioquímicas. Menciona el dictamen C-175-2005 de la PGR. Respecto de los antecedentes, refuta las aseveraciones del accionante, pues el decreto ejecutivo objeto de la presente acción no busca otorgar más tiempo al sector empresarial para la comercialización de agroquímicos. Considera que, más bien, se imponen obligaciones de actualización de información a estas empresas. Dice que no se está frente a una competencia concurrente entre el MAG, el Ministerio de Salud y el MINAE, pues la ley n.°7664 otorga la competencia en materia de registro de plaguicidas al SFE. Agrega que el informe DFOE-AM-19-2004 resulta inaplicable, contrario a lo aseverado por el accionante. Reitera lo dicho por el MAG, en cuanto al denominado principio de no repetición de estudios y en cuanto a que la disputa debería dirimirse en la sede de legalidad y no de constitucionalidad. Reproduce el argumento sostenido por dicho órgano ministerial en el sentido de que el decreto objeto del presente proceso no permite otorgar registros para nuevos productos, así como el argumento de la consolidación de la situación jurídica derivada del registro. Rechaza las afirmaciones que hace el accionante a través de las conclusiones presentes en el escrito de interposición. Solicita que se declare sin lugar la acción de inconstitucionalidad. Aporta como documentos el informe del MAG ya indicado, así como la personería jurídica de la asociación en cuestión.

8.- Mediante escrito recibido a las 13:22 hrs. del 29 de mayo de 2019, el señor Juan Rafael Lizano Sáenz, cédula de identidad n.°1-0379-0262, en su calidad de presidente de la Cámara Nacional de Agricultura y Agroindustria (CNAA), cédula jurídica n.° 3-002-051316, presenta coadyuvancia pasiva en este proceso. Luego de realizar un recuento de antecedentes fácticos, indica que su legitimación como coadyuvante proviene del objeto de la CNNA, que agrupa a productores, empresarios y entes del sector agropecuario y agroindustrial. Refiere que la asociación integra a diferentes asociados de varios actores del sector agrícola, y que precisamente de allí proviene su legitimación, pues su actividad comercial implica el registro y aplicación de plaguicidas. Indica que el proceso afecta los intereses de los diferentes grupos que integran dicha asociación, lo que constata el interés legítimo suficiente para efectos de admitir la coadyuvancia pasiva. Luego de reiterar los argumentos del accionante, procede a iniciar su exposición a propósito de la improcedencia de la acción de la inconstitucionalidad. En primer término, alude a que la reforma operada a través del decreto ejecutivo n.°41481-MAG se realizó con apego a lo estipulado en estudios técnicos y científicos, según estándares internacionales. En cuanto al criterio de otros órganos como la PGR y el MINAE, indica que esta Sala Constitucional no puede entrar a valorar los temas estrictamente técnicos y cita a su favor la resolución n.°7009-2019. Insiste que en tratándose de la valoración sobre la validez de estudios técnicos y científicos en materia ambiental lo procedente es que se discuta en una vía distinta a la constitucional e invoca las resoluciones números 6922-2008 y 7009-2019. Alega que tales valoraciones escapan a la vía sumaria del amparo. Por otra parte, alude a la competencia que otorgan distintas normas legales y reglamentarias, así como constitucionales, al Poder Ejecutivo en sentido estricto para la promulgación de decretos ejecutivos y, siendo que dichas normas otorgan competencia al MAG, lo hacen con exclusión de otros órganos, por lo que rechaza los argumentos de quien acciona. Solicita se tenga por admitida la coadyuvancia y que se rechace por el fondo la presente acción de inconstitucionalidad. Adjunta la certificación de su personería jurídica.

9.- Por escrito recibido a las 14:50 hrs. del 29 de mayo de 2019, el señor Federico Lizano González, cédula de identidad n.°1-0793-0229, en su condición de representante legal de la Cámara de Insumos Agropecuarios de Costa Rica, cédula jurídica n.°3-002-045217, procede a interponer coadyuvancia pasiva en este proceso. En cuanto a su legitimación como coadyuvante, sostiene que su representada es una organización constituida por empresas del sector proveedor de insumos y tecnología para el sector agrícola, de allí que la validez del decreto ejecutivo n.°41481-MAG afecta directamente los intereses de la Cámara y de sus afiliados. Lo anterior en el tanto sus asociados realizan procedimientos de inscripción de insumos agrícolas e indican que lo que resuelva esta Sala Constitucional incide directamente en el quehacer de la Cámara y de sus asociados. En cuanto al fondo del asunto, estima que la acción debe declararse sin lugar. Menciona que la potestad reglamentaria que ostenta el Poder Ejecutivo tiene rango constitucional, y que no se encuentra sujeta a más límites que a la regularidad jurídica y la reserva de ley. Por otro lado, alega que los registros por incorporación y por equivalencia se basan en la racionalización de la intervención estatal; que se acuda a esta información obtenida de altos estándares no hace peligrar el ambiente ni la salud. Sostiene que el decreto en cuestión alude a los productos que ya se encuentran en el mercado y que ya fueron debidamente evaluados. En cuanto a la reducción de los plazos, considera que dicha norma no es contraria al Derecho constitucional, pues se inserta en el marco de la mejora regulatoria y de la mejor prestación del servicio público. Solicita que se admita la coadyuvancia y que se declare sin lugar en todos los extremos la presente acción de inconstitucionalidad.

10.- Por escrito recibido a las 14:40 hrs. del 29 de mayo de 2019, el señor Manrique Constela Umaña, en su condición de apoderado generalísimo sin límite de suma de Polymer S.A., presenta coadyuvancia pasiva en el presente proceso de constitucionalidad. Para sustentar su legitimación como coadyuvante, indica que la empresa se dedica a la producción de empaques plásticos para la industria, la agricultura y el consumo personal. Afirma que el interés legítimo en relación con esta acción deriva del hecho de que con frecuencia deben solicitar el registro o la reválida de productos agroquímicos o agrobiológicos. En cuanto al fondo del asunto, solicitan que la acción de inconstitucionalidad debe ser rechazada de plano, por cuanto no considera que cumple los requisitos de admisibilidad. Estima que el interés que persigue la parte accionante es individual y directo y que en verdad no acciona en defensa del medio ambiente o del derecho a la salud. Menciona que en verdad los accionantes pretenden atacar normas que estiman contrarios a sus intereses económicos y cita en defensa de sus argumentos distintas resoluciones de la Sala Constitucional, incluyendo la resolución n.°8470-2007. Considera que la parte actora carece de legitimación activa en este proceso y que por ende debe ser rechazado de plano. Por otro lado, sostiene que el escrito carece de una adecuada fundamentación por cuanto procede a reiterar los argumentos ya esgrimidos en el proceso tramitado bajo expediente 18-19039-0007-CO. En otro orden de ideas, sugiere que este proceso sea acumulado al que se tramita en dicho expediente e indica que las normas impugnadas no deben suspenderse, como lo solicitó la parte accionante. Después se refiere el escrito a la constitucionalidad de las normas en cuestión. En primer término, reitera lo ya dicho sobre la asignación constitucional de la potestad reglamentaria en manos del Poder Ejecutivo, lo cual respalda en citas doctrinarias. Hace ver que de conformidad con la ley n.°7664, le corresponde al MAG reglamentar dicha norma, por la estructura organizativa y técnica que ha de tener. Explicar los alcances del principio de legalidad y su relación con la competencia, con base en doctrina y en dictámenes de la PGR, que aplica lo anteriormente expuesto a la competencia en materia fitosanitaria y a tenor de la Ley de Protección Fitosanitaria. Indica que el SFE cuenta con la especialidad técnica para el desarrollo de sus competencias vinculadas al control de las sustancias químicas, biológicas o afines para uso agrícola. Señala que solo el MAG es quien tiene la competencia para emitir una opinión adecuada sobre el registro o reválida de productos de uso agrícola. Desestima los reproches del accionante en cuanto a que el decreto objeto de este proceso beneficie a los productores, pues más bien considera que se ajusta a los principios del servicio público, para lo cual trae a colación el art. 4 de LGAP y la resolución 5600-2005 de este Tribunal Constitucional. Menciona que de modo alguno la reducción de plazos implica un favorecimiento a las empresas vendedoras de agroquímicos; por el contrario, obedece al criterio técnico que tiene el SFE, con arreglo a los principios de eficacia, eficiencia y celeridad. Complementa a dicha argumentación la aplicación de la ley n.°8220. Estima que la reducción de plazos no es contraria a los derechos fundamentales de salud y protección del medio ambiente, lo cual respalda en jurisprudencia de este órgano jurisdiccional. Señala en este escrito que la eliminación de requisitos no es inconstitucional, pues acusa un rezago en la normativa técnica en cuestión, derivado de lo que considera una mala concepción de la protección ambiental y sanitaria. Expone la diferencia entre plaguicida formulado e ingrediente activo grado técnico, así como la distinción entre registro por incorporación y registro por equivalencia y alega que el decreto en cuestión no elimina requisitos necesarios para la protección de la salud o del medio ambiente, sino que establece regulaciones racionales y acordes con la gran utilidad pública derivada del registro de productos agroquímicos. Pide que se rechace de plano la acción y, en caso de no acogerse esta solicitud, se acumule al expediente n.°18-19039-0007-CO. También pide que la acción de inconstitucionalidad sea declarada sin lugar en todos sus extremos, así como una interpretación del decreto en cuestión conforme a la Constitución Política, en caso de que la Sala Constitucional estime que la aplicación del decreto en cuestión trasgreda normas y principios constitucionales.

11.- La Presidencia de la Sala Constitucional, a través de la resolución de las 15:48 hrs. del 30 de mayo de 2019, resolvió lo atinente a las coadyuvancias:

“En el caso concreto, el gestionante Enrique García González, se apersonó el veinte de mayo de dos mil diecinueve, sin embargo, no logró acreditar su interés para apersonarse como coadyuvante en el presente asunto, de ahí que no pueda tenerse por aceptada su solicitud, en atención a lo dispuesto por el artículo 83 de la Ley de la Jurisdicción Constitucional.

Por otra parte, los coadyuvantes Constenla Umaña, Osborne Escalante, Lizano González y Lizano Saénz, se apersonaron el veintinueve de mayo del dos mil diecinueve y solicitan ser tenidos como coadyuvantes por considerar que lo resuelto en la presente acción de inconstitucionalidad puede eventualmente tener incidencia en sus actividades comerciales. En consecuencia y siendo que la primera publicación del aviso se dio el ocho de mayo del dos mil diecinueve, lo procedente es tenerlos como coadyuvantes dentro de este asunto”.

Asimismo, se tuvieron por contestadas las audiencias conferidas a la PGR y al MAG.

12.- Por escrito suscrito el 27 de agosto de 2019, el señor Ministro de Agricultura y Ganadería, Luis Renato Alvarado Rivera, solicitó aclaración del auto de las 14:45 hrs. del 08 de abril de 2019, en lo atinente a los efectos sobre los procedimientos administrativos de actualización de los expedientes de registro. Asimismo, insiste en lo siguiente:

“No omitimos expresarle a la Honorable Sala, que la norma impugnada no se refiere a nuevos registros para ser concedidos, sino a una actualización de la información de registros actuales, que fueron concedidos en el pasado, después de haber pasado por la evaluación de los ministerios de Agricultura y de Salud. Además, no se refiere a productos que fueron autorizados por primera vez en Costa Rica a nivel mundial, sino que ya habían sido evaluados de manera integral (en los aspectos agronómicos, de salud y ambiente) y aprobados por entidades regulatorias de los países de origen de los mismos, como son Estados Unidos de Norte América, la Unión Europea, Japón entre otros.

La actualización que se propone en la norma impugnada viene más bien a ordenar el sistema regulatorio nacional, pues manda poner al día la información de origen en los expedientes de los registros actuales”.

13.- Por escrito presentado el 1° de noviembre de 2019 (sin la correspondiente firma) el señor Henry José Picado Cerdas, cédula de identidad n.°3-0403-0272, en su calidad de ciudadano interesado, procede a solicitar apersonamiento en el presente proceso.

15.- En los procedimientos se han cumplido las prescripciones de ley.

Redacta la Magistrada Garro Vargas;

CONSIDERANDO

I.- SOBRE LA ÚLTIMA GESTIÓN DE COADYUVANCIA En memorial recibido en la Secretaría de la Sala el 1° de noviembre de 2019 se presentó un documento que carece de firma, suscrito supuestamente por el señor Henry José Picado Cerdas, cédula de identidad n.°3-0403-0272. Únicamente manifestó que en su calidad de ciudadano interesado solicitaba el apersonamiento en el presente proceso. Dicha gestión es inadmisible por varios motivos. Como ya se apuntó, el documento carece de firma física o digital que permita corroborar la validez de la gestión en un proceso que es de índole formal como lo es la acción de inconstitucionalidad. En segundo lugar, la parte no fundamenta en qué motiva su deseo de apersonarse al proceso y, por último, de considerarse que se trata de una coadyuvancia, esta fue planteada de forma extemporánea. Por lo tanto, se rechaza la gestión.

II.- SOBRE LA ADMISIBILIDAD DE LA ACCIÓN DE INCONSTITUCIONALIDAD. LEGITIMACIÓN Sobre el particular, debe señalarse que el art. 75 párrafo 2 de la Ley de la Jurisdicción Constitucional (LJC), establece que no será necesario el caso previo pendiente de resolución cuando por la naturaleza del asunto no exista lesión individual y directa, o se trate de la defensa de intereses difusos, o que atañen a la colectividad en su conjunto. En este sentido la Sala Constitucional, en su sentencia n.º2001-8239, se refirió a los intereses difusos, en los siguientes términos:

“De acuerdo con el primero de los supuestos previstos por el párrafo 2° del artículo 75 de la Ley de la Jurisdicción Constitucional, la norma cuestionada no debe ser susceptible de aplicación concreta, que permita luego la impugnación del acto aplicativo y su consecuente empleo como asunto base. (...) En segundo lugar, se prevé la posibilidad de acudir en defensa de intereses difusos (...) Los intereses difusos, aunque de difícil definición y más difícil identificación, no pueden ser en nuestra ley -como ya lo ha dicho esta Sala- los intereses meramente colectivos; ni tan difusos que su titularidad se confunda con la de la comunidad nacional como un todo, ni tan concretos que frente a ellos resulten identificados o fácilmente identificables personas determinadas, o grupos personalizados, cuya legitimación derivaría, no de los intereses difusos, sino de los corporativos que atañen a una comunidad en su conjunto. Se trata entonces de intereses individuales, pero a la vez, diluidos en conjuntos más o menos extensos y amorfos de personas que comparten un interés y, por ende, reciben un perjuicio, actual o potencial, más o menos igual para todos, por lo que con acierto se dice que se trata de intereses iguales de los conjuntos que se encuentran en determinadas circunstancias y, a la vez, de cada una de ellas. Es decir, los intereses difusos participan de una doble naturaleza, ya que son a la vez colectivos -por ser comunes a una generalidad- e individuales, por lo que pueden ser reclamados en tal carácter. (...) En síntesis, los intereses difusos son aquellos cuya titularidad pertenece a grupos de personas no organizadas formalmente, pero unidas a partir de una determinada necesidad social, una característica física, su origen étnico, una determinada orientación personal o ideológica, el consumo de un cierto producto, etc.” En el presente asunto, el accionante aduce su legitimación por vía del control abstracto de constitucionalidad e invoca la defensa de intereses difusos, toda vez que acude en resguardo del derecho a un ambiente sano y equilibrado y del derecho a la salud de la población, relacionado con la inscripción de plaguicidas que tienen una evidencia incidencia sobre estos. Por consiguiente, tal circunstancia configura a favor del gestionante una legitimación directa para la interposición del presente proceso, por invocar la defensa de intereses que atañen a la colectividad nacional en su conjunto.

Por lo anterior, resulta admisible el conocimiento y resolución de la presente acción de inconstitucionalidad por vía del control abstracto.

III.- SOBRE EL OBJETO DE LA ACCIÓN Esta acción tiene por objeto resolver los agravios de inconstitucionalidad planteados contra el decreto ejecutivo n.°41481-MAG, denominado “Reforma Reglamento para la actualización de la información de los expedientes de registro de ingrediente activo grado técnico y plaguicidas formulados”. Por la extensión de la norma no se cita acá su contenido completo, sino que se transcribirán las disposiciones y se atenderán los agravios de forma particular en el respectivo considerando.

En términos generales, se acusa que el decreto implica un beneficio a los comercializadores de plaguicidas, pues amplía el tiempo a cinco años sin que dichos productos deban ser sometidos a una evaluación de riesgo. Se acusa que este tipo de decreto lo único que busca es dar más tiempo a las empresas vendedoras de agroquímicos para que sigan con el proceso de la comercialización y el uso de sustancias que son peligrosas y que pueden ocasionar un grave daño a la salud de la población costarricense, afectar la biodiversidad y dañar el medio ambiente, pues los registros no han sido evaluados integralmente. En otras palabras, que los productos en cuestión no tienen el estudio de toxicología crónica y a ninguno de estos registros se les ha realizado la valoración ecotoxicológica y muchos podrían no estar funcionando en las dosis que fueron registradas. Además, que el decreto carece de fundamentación técnica sobre la materia de plaguicidas y busca flexibilizar los requisitos, en detrimento de la vida y la salud de las personas. Se cuestiona el tema de los plazos previstos para la presentación y resolución de las gestiones y que se haya excluido del proceso a las autoridades del Ministerio de Salud y del MINAE.

Anteriormente (ver sentencia n.°2022-026651), esta Sala tomó nota de que en el ínterin de la tramitación de esta acción se dictaron nuevos decretos ejecutivos que podrían tener impacto en la vigencia de esta normativa. Concretamente en el decreto ejecutivo n.°43469 del 06 de abril de 2022, “Reglamento técnico RTCR 504:2021. Reglamento para el Registro de Insumos Agrícolas. Plaguicidas Sintéticos Formulados, Ingrediente Activo Grado Técnico, Coadyuvantes, Sustancias afines y Vehículos Físicos de Uso Agrícola” se establecieron dos normas transitorias que disponen que el Poder Ejecutivo promulgará un nuevo reglamento técnico específico que regule la actualización de los registros:

“TRANSITORIO 5. El Poder Ejecutivo en el plazo de seis meses contado a partir de la fecha de entrada en vigencia del presente reglamento promulgará un reglamento técnico específico que regule la actualización de registros de ingrediente activo grado técnico y plaguicidas sintéticos formulados, otorgados con fundamento en un cuerpo normativo distinto al presente reglamento, el Decreto Ejecutivo N° 33495 MAG-SMINAE- MEIC "Reglamento sobre Registro, Uso y Control de Plaguicidas Sintéticos Formulados, Ingrediente Activo Grado Técnico, Coadyuvantes y Sustancias Afines de Uso Agrícola" o en el Decreto Ejecutivo N° 42769-MAG-S-MINAE "Reglamento para optar por el Registro de Ingrediente Activo Grado Técnico mediante el reconocimiento de la evaluación de los estudios técnicos aprobados por las Autoridades Reguladoras de los países miembros de la OCDE y los países adherentes de la OCDE". Este reglamento técnico deberá al menos considerar los requisitos, procedimientos, la priorización de la actualización, los plazos conforme a las capacidades de la AC y las autoridades revisoras competentes, así como el establecimiento técnico de los perfiles de referencia para la evaluación de todos aquellos productos que se registraron con normativa diferente a la citada. El registrante podrá hacer referencia a información ya presentada en procesos anteriores de reválida, actualización o renovación cuando corresponda.

TRANSITORIO 6. Los registros otorgados con fundamento en un cuerpo normativo distinto al presente reglamento, el Decreto Ejecutivo N° 33495 MAG-SMINAE- MEIC "Reglamento sobre Registro, Uso y Control de Plaguicidas Sintéticos Formulados, Ingrediente Activo Grado Técnico, Coadyuvantes y Sustancias Afines de Uso Agrícola" o en el Decreto Ejecutivo N° 42769-MAG-S-MINAE "Reglamento para optar por el Registro de Ingrediente Activo Grado Técnico mediante el reconocimiento de la evaluación de los estudios técnicos aprobados por las Autoridades Reguladoras de los países miembros de la OCDE y los países adherentes de la OCDE'', deberán realizar la actualización conforme al reglamento establecido para estos efectos de conformidad con el transitorio 5. Estos registros se considerarán vigentes durante un plazo de cinco años a partir de la entrada en vigencia del presente reglamento. Dicho plazo se entenderá prorrogado por un plazo igual para los trámites que se hayan sometido a la actualización conforme al reglamento indicado en el transitorio 5 si al vencimiento de este las autoridades revisoras competentes aún no han finalizado la revisión de los trámites de actualización”.

Adicionalmente, se tiene que mediante el decreto ejecutivo n.º43838-MAG-S-MINAE se dictó propiamente un reglamento técnico denominado “RTCR 509:2022. Insumos Agrícolas. Plaguicidas Sintéticos Formulados, Ingrediente Activo Grado Técnico, Coadyuvantes, Vehículos Físicos y Sustancias Afines de Uso Agrícola. Registro” publicado en el Diario Oficial La Gaceta n.°253, Alcance n.°278 de fecha 21 de diciembre de 2022 (https://www.imprentanacional.go.cr/pub/2022/12/21/ALCA278_21_12_2022.pdf ), en el que se ordenó derogar el decreto ejecutivo n.°39995-MAG del 15 de diciembre del 2016, “Reglamento para la actualización de la información de los expedientes de registro de ingrediente activo grado técnico y plaguicidas formulados" y su reforma, publicado en Alcance No 10. del 16 de enero del 2017” (reformado por el decreto n.°41481-MAG objeto de esta acción). Dicha normativa empezará a regir a partir del 21de marzo de 2023, por lo que la derogatoria se hará efectiva hasta ese momento. En consecuencia, los cuestionamientos de constitucionalidad siguen vigentes.

IV.- SOBRE LA PROTECCIÓN FITOSANITARIA, RAIGAMBRE CONSTITUCIONAL En primer término, conviene enfatizar que las medidas de protección fitosanitaria tienen raigambre en nuestro Estado Social de Derecho, en el tanto procuran tutelar al mismo tiempo valores de gran trascendencia constitucional: la salud (art. 21), la protección de los derechos del consumidor concretamente a la salud y al ambiente (art. 46), así como la estimulación de la producción agrícola de tanta importancia para nuestro país paralelamente con la protección del medio ambiente (art. 50) y tales fueron los principios constitucionales que tuvo en consideración el legislador al promulgar la Ley de Protección Fitosanitaria. Así ha sido reconocido por este Tribunal en múltiples resoluciones. Por ejemplo, en la sentencia n.°2009-013606 la Sala realizó las siguientes consideraciones:

“El artículo 1° de la Ley de Protección Fitosanitaria indica claramente: “Decláranse de interés público y aplicación obligatoria, las medidas de protección fitosanitaria establecidas en esta ley y sus reglamentos.” Dicha ley atiende a principios y necesidades fundamentales para la estabilidad del país, como lo son la seguridad alimentaria y la actividad económica sustentada en la producción agrícola. Esto encuentra fundamento en varios artículos de nuestra Constitución Política. Así, de conformidad con el artículo 50 de "el Estado procurará el mayor bienestar a todos los habitantes del país, organizando y estimulando la producción y el más adecuado reparto de la riqueza". Además, según esta norma, debe garantizar, defender y preservar el derecho de toda persona a un ambiente sano y ecológicamente equilibrado, para lo cual la ley determinará las responsabilidades y las sanciones correspondientes. Por otra parte, del artículo 21 de la Constitución Política que consagra la inviolabilidad de la vida humana se desprende el derecho a la salud, al bienestar físico, mental y social de las personas y la obligación del Estado de protegerlos (Sala Constitucional, Voto No. 3705-93 de 15 horas del 30 de julio de 1993). Asimismo, el artículo 46 in fine consagra el derecho de todos los consumidores y usuarios a la protección de su salud, ambiente, seguridad e intereses económicos. Tales fueron los principios constitucionales que tuvo en consideración el legislador al promulgar la Ley de Protección Fitosanitaria, No. 7664 de 8 de abril de 1997. Entre sus objetivos principales están evitar y prevenir la introducción y difusión de plagas, proteger los vegetales de los perjuicios causados por éstas, regular su combate, fomentar el manejo integrado de plagas dentro de programas de desarrollo sostenible, regular el uso y manejo de sustancias químicas, biológicas o afines y de los equipos para aplicarlas en la agricultura, así como evitar que las medidas fitosanitarias constituyan un obstáculo innecesario para el comercio internacional (artículo 2).

La Ley dispone un procedimiento especial para la atención de emergencias fitosanitarias que puedan comprometer la seguridad alimentaria y la economía del país, y otorga a la Administración determinadas potestades para adoptar todas aquellas medidas que permitan el control de una situación de esa naturaleza. Si es deber constitucional del Estado la organización de la producción nacional, lo es también, por consecuencia, el diseño de mecanismos de control de las plagas que puedan afectarla negativamente, para lo cual se acude a diferentes técnicas como la declaratoria de cuarentenas, la destrucción de vegetales, el control de ingreso y en el país de origen de vegetales o agentes de control biológico, el manejo integrado de plagas, entre otros. En este sentido, el combate de las plagas debe ser un esfuerzo compartido entre el Estado y los particulares involucrados en una situación de esta naturaleza. Sin embargo, si frente a una situación concreta el particular no acata los lineamientos dispuestos por el Servicio Fitosanitario del Estado para el combate de una plaga, la Administración no solo puede, sino que está obligada a sustituirlo y ejecutar los trabajos de control que sean necesarios y que permitan la contención oportuna de los focos de infección que existan. Ahora bien, esa conducta de la Administración no debe generarle a ésta responsabilidad patrimonial alguna, pues se encuentra motivada precisamente en la omisión del particular, quien es el primer llamado a combatir la situación infecciosa de conformidad con las instrucciones giradas al efecto por el Servicio Fitosanitario. Esta es la razón que justifica la eximente de responsabilidad que establece el artículo 15 impugnado. La tutela del orden público está por encima del interés individual, pero es la negligencia del particular lo que justifica que no obstante que la actuación de la Administración le cause un daño de excepcional intensidad, no exista fundamento jurídico para reclamarle al Estado indemnización alguna, máxime si se considera que esa negligencia no solo lo puede afectar a él, sino que puede comprometer el bienestar y el interés general de la sociedad.

La negligencia y omisión del particular obligan entonces a la Administración a desplegar su poder de policía con el fin de proteger el interés público social. Cuando hablamos de “poder de policía” en un sentido amplio, nos referimos a aquel conjunto de medidas dirigidas a proteger la seguridad, la moralidad y la salubridad públicas, así como la defensa y promoción de los intereses económicos de la colectividad y al bienestar general de la misma. Se manifiesta, en principio, como una potestad atribuida al poder legislativo y por ello es indelegable. Sin embargo, el legislador puede crear en la ley ordinaria una imputación de funciones, asignándole al poder ejecutivo, por ejemplo, la atribución de estatuir sobre determinadas materias, dentro de los límites preestablecidos en la ley; tal es lo que ocurre en el presente caso. La Ley de Protección Fitosanitaria, otorga al Poder Ejecutivo, a través del Ministerio de Agricultura y Ganadería, las potestades necesarias para controlar los posibles focos de infección y/o plagas”. (Lo destacado no corresponde al original).

En esa misma línea, este Tribunal ha sido consciente de que los componentes químicos para contener las plagas en los productos agrícolas tienen un claro y notable impacto en el medio ambiente (la saturación y fertilización de los suelos), pero también en la seguridad alimentaria (el acceso a los alimentos) y, por ello, es necesario que el Estado asuma una conducta proactiva y vigilante en la materia. En efecto, el Estado tiene la obligación de regular el uso de las sustancias químicas o afines para uso agrícola, de forma que sean manejadas correcta, razonablemente y que no generen riesgos para la salud humana y el ambiente. Además, tiene la responsabilidad de garantizar el bienestar de los habitantes y un ambiente ecológicamente equilibrado. En la sentencia n.°2021-019096 se resolvió lo siguiente:

“VI.- SOBRE LA REGULACIÓN DEL USO DE LOS PESTICIDAS Como se indicó líneas atrás, el derecho a la vida, a la salud y a un ambiente sano, son derechos fundamentales regulados en los artículos 21 y 50, de la Constitución Política y su protección es de interés público. Precisamente, es por esa razón que el Estado tiene la obligación, en aras de proteger la salud de la población, y el principio precautorio ambiental de regular el uso de las sustancias químicas o afines para uso agrícola, de forma que sean manejadas correcta, razonablemente y que no generen riesgos para la salud humana y el ambiente. Además, que también tiene la responsabilidad de garantizar el bienestar de los ciudadanos y un ambiente ecológicamente equilibrado. En torno a esto, la Sala ha establecido que el Estado debe tener un papel de garante con respecto al uso adecuado de plaguicidas y la evitación de sus efectos nocivos sobre la salud y el ambiente. En este sentido, en Sentencia N° 2004-13968 de las 11:35 horas del 3 de diciembre de 2014, indicó:

“III.- Ese informe [FOE-AM-19/2004 del 20 de octubre del 2004, efectuado por el Área de servicios agropecuarios y de medio ambiente de la División de fiscalización operativa y evaluativa de la Contraloría General de la República, sobre la evaluación de la gestión del Estado en relación con el control de plaguicidas agrícolas] se originó por la necesidad de fiscalizar el proceso administrativo relacionado con uno de los problemas ambientales más apremiantes que debe resolver el país, que es el empleo de sustancias químicas, biológicas o afines en las actividades agrícolas, y ante la necesidad de que el Estado intervenga ejerciendo una función reguladora sobre el uso de agroquímicos, que garantice a los agricultores la disponibilidad en el mercado de productos eficaces para el combate de las plagas y, a la vez, la protección de la salud de la ciudadanía en general y el derecho de ésta a un ambiente sano y ecológicamente equilibrado. Se indicó en el informe que ese control lo ejerce principalmente el Ministerio de Agricultura y Ganadería, por medio del Servicio Fitosanitario del Estado, quien debe trabajar en coordinación con el Ministerio de Salud y el Ministerio del Ambiente y Energía, en cuanto al control sobre los impactos en la salud y el ambiente, así como con el Ministerio de Hacienda respecto a la importación y exoneración de tales productos. Su objetivo general fue evaluar la gestión del Estado en relación con el control de plaguicidas utilizados en actividades agrícolas y su efecto sobre el ambiente y la salud humana, principalmente el accionar del Servicio Fitosanitario del estado del Ministerio de Agricultura y Ganadería (MAG); y los objetivos específicos del estudio fueron: a) evaluar las políticas nacionales y la rectoría en el campo del control sobre el uso de plaguicidas, identificando las instituciones participantes y sus competencias, b) evaluar el proceso de registro de plaguicidas en el país y la normativa asociada, c) evaluar el proceso de exoneración e importación de plaguicidas en el país y, d) evaluar la fiscalización y monitoreo sobre el uso de plaguicidas.

IV.- En ese informe concluyó la Contraloría que el Servicio Fitosanitario del Estado (SFE) no cumple sus objetivos de creación con eficiencia y apego al principio de legalidad, que lo llaman a regular, ejecutar y fiscalizar el registro y uso de agroquímicos, en el marco de una actividad agrícola en armonía con la naturaleza y con fiel cumplimiento de los principios constitucionales de derecho a la vida, a la salud y a un ambiente sano. Determinó que, por el contrario, el accionar de dicho órgano se orienta a facilitar el registro y comercialización de tales sustancias, justificado en un supuesto interés de mejorar la competitividad de los productores agrícolas, pero más bien, esos objetivos parecen dirigirse a fomentar la competencia en el mercado de los plaguicidas, por encima de los derechos constitucionales de los mismos agricultores y de los principios ambientales y de salud de las personas. Concluyó que las empresas más beneficiadas con la función facilitadora del SFE, han sido las empresas que se dedican a la venta de agroquímicos, especialmente a los denominados genéricos, en detrimento de los productores y consumidores de bienes agrícolas. Aclaró que ello no significa que no puedan registrarse en el país, plaguicidas de este tipo, sino más bien que su registro se debe hacer respetando la normativa y asegurando a la población costarricense la protección de su salud y el derecho fundamental que tiene a un ambiente sano y ecológicamente equilibrado, y protegerle al agricultor nacional su derecho a contar con insumos de buena calidad; sin perjuicio de las necesarias acciones que el Estado debe ejecutar para buscar la paulatina reducción del uso de plaguicidas y el fomento de mecanismos alternativos. Estas consideraciones motivaron a la Contraloría General de la República a dictar una serie de disposiciones finales dirigidas al Presidente de la República y a los Ministros de Planificación Nacional y Política Económica, Agricultura y Ganadería, Salud, Ambiente y Energía, y Economía, Industria y Comercio, así como al Auditor Interno del Ministerio de Agricultura y Ganadería”.

De igual modo, en la Sentencia N° 2006-09565, de las 16:08 horas del 5 de julio de 2006, este Tribunal consideró:

“ (… ) es evidente que el Estado costarricense está en el deber de actuar en forma eficaz y anticipada, para evitar la ocurrencia de eventos que degraden el medio ambiente y comprometan su sostenibilidad".

Y, en la N° 2011-016937 de las 14:36 horas del 7 de diciembre de 2011, dispuso:

“ (…) VIII.- SOBRE LA REGULACIÓN EN MATERIA DE REGISTRO DE LOS PLAGUICIDAS. El uso adecuado de los plaguicidas puede resultar útil para el control y eliminación de las plagas, en beneficio de la seguridad alimentaria de la población y de la actividad económica sustentada en la producción agrícola. Sin embargo, debe reconocerse el riesgo potencial que puede implicar para la salud humana y el ambiente el uso de tales sustancias. Lo que incluso ha motivado la adopción de instrumentos internacionales con el objetivo expreso de proteger la salud humana -incluida la salud de los consumidores y de los trabajadores- y el medio ambiente frente a los posibles efectos perjudiciales de los plaguicidas, como es el caso del Convenio de Rotterdam para la Aplicación del Procedimiento de Consentimiento Fundamentado Previo a Ciertos Plaguicidas y Productos Químicos Peligrosos Objeto del Comercio Internacional, que fue aprobado por Costa Rica, por medio de Ley No. 8705 del 13 de febrero del 2009.

(… ) este Tribunal ha reconocido el riesgo que puede entrañar el uso de los plaguicidas y la trascendencia de adoptar medidas idóneas para regular su empleo. En el ordenamiento jurídico costarricense existe diversa normativa legal y reglamentaria de la que se deriva que la actividad de importación, fabricación, comercialización y empleo de los plaguicidas está fuertemente sometida a la potestad de policía del Estado, en aras de garantizar el derecho a la salud y al medio ambiente sano y ecológicamente equilibrado”. (Consideraciones que fueron reiteradas en la sentencia n.°2021-024807).

Haciendo eco de estos principios constitucionales se ha emitido normativa legal declarada de interés público por parte del legislador para atender esta importante materia. Por ejemplo, la mencionada Ley de Protección Fitosanitaria en el art. 1° dispone que se declara “de interés público y aplicación obligatoria, las medidas de protección fitosanitaria establecidas en esta ley y sus reglamentos”; la Ley General de Salud (declarada de interés público en el art. 7) también contiene disposiciones generales en lo relativo al manejo de estas sustancias; y la Ley de Uso, Manejo y Conservación de Suelos (también de interés público en virtud de lo dispuesto expresamente en los arts. 3 y 61 de la ley) incluye disposiciones y competencias a favor del MINAE en lo relativo a las actividades que puedan causar contaminación de los suelos (ver art. 28 y ss.).

De este modo, se aprecia un ámbito de acción del Estado costarricense muy amplio respecto del uso de los agroquímicos, que incluye regular tanto el uso y manejo de sustancias químicas, biológicas o afines y equipos para aplicarlas en la agricultura como su registro, importación, calidad y residuos, procurando al mismo tiempo proteger la salud humana y el ambiente.

En lo que atañe al objeto de esta acción de inconstitucionalidad interesa en particular el tema de la “inscripción” de los productos, que se encuentra regulado de forma más pormenorizada en los arts. 23, 24 y 25 de la Ley de Protección Fitosanitaria. Estos establecen el registro e inscripción, como uno de los mecanismos de control de establecimientos e insumos para uso agrícola. Específicamente, y de particular relevancia para esta acción de inconstitucionalidad, el art. 23 de la ley señala lo siguiente:

“Art. 23 - Inscripción de sustancias y equipos Según los requisitos que se señalarán en el reglamento de esta ley, todas las sustancias químicas, biológicas o afines y los equipos de aplicación para uso agrícola, deberán inscribirse en el registro que el Servicio Fitosanitario del Estado creará para disponer de información sobre las características de estos y velar por su correcta utilización en el país”.

Como se examinará en lo sucesivo, la normativa objeto de acción responde justamente a esta obligación del Estado, confiada en el SFE, de mantener actualizado el registro de las sustancias que son de utilización para uso agrícola.

V.- ANTECEDENTES EN LA JURISDICCIÓN CONSTITUCIONAL La materia que se somete a análisis ha sido examinada desde distintas aristas por parte de este Tribunal.

En la sentencia n.°2017-06668, sobre la constitucionalidad del decreto ejecutivo n.°39995-MAG (que luego fue reformado por el decreto objeto de esta acción) se resolvió lo siguiente:

“SOBRE EL FONDO. ACERCA DE LA ALEGADA VIOLACIÓN DEL DERECHO PROTEGIDO EN EL ARTÍCULO 50 DE LA CONSTITUCIÓN POLÍTICA, RELATIVO A UN MEDIO AMBIENTE SANO Y ECOLÓGICAMENTE EQUILIBRADO. Acusa el actor la violación del derecho protegido en el artículo 50 de la Constitución Política, en concreto, de los principios precautorio y de inversión de la carga de la prueba en materia ambiental, dado que, por un lado, la normativa discutida exige a la Administración demostrar la existencia de un riesgo inaceptable para la salud humana, el ambiente o la agricultura, para que se restringa o prohíba el registro de ingrediente activo y plaguicidas formulados, pese a los alcances del principio supra aludido y, por otro, el hecho que, según la normativa impugnada, le atañe a la Administración, no así al titular de la actividad, acreditar la existencia de un riesgo de los bienes jurídicos mencionados, cuando el principio en cuestión demanda lo contrario. Al respecto, el artículo 7° del Decreto Ejecutivo No. 39995-MAG, Reglamento para la actualización de la información de los expedientes de registro de ingrediente activo grado técnico y plaguicidas formulados (que es, en el fondo, el que impugna el actor), estipula lo siguiente:

“ARTICULO 7. Durante el plazo de vigencia de un registro, cuando los Ministerios competentes demuestren un riesgo inaceptable para la salud humana, el ambiente o la agricultura, el Servicio Fitosanitario del Estado restringirá o prohibirá su uso”.

La norma, per se, tiene como fin proteger el medio ambiente y la salud humana, por cuanto, precisamente busca restringir o prohibir el uso de un registro vigente cuando exista un riesgo inaceptable, consecuentemente, lejos de lesionar esos bienes constitucionales los tutela. Cuando se va a proceder al registro de un ingrediente activo o plaguicida es el momento propicio para aplicar el principio precautorio. Es de suponer que durante ese procedimiento de inscripción de un registro, puede surgir la circunstancia que existe alguna duda técnica o científica acerca del impacto del producto sobre la salud humana, el ambiente o la agricultura. En ese momento de tramitación es que puede aplicarse el principio precautorio, sea que ante la duda la administración debe decidir no inscribir un registro. La norma reglamentaria impugnada, esto es, el artículo 7° se refiere a una etapa ulterior a ésta, por cuanto, supone que el procedimiento de inscripción ya ha sido sustanciado, concluido y ya existe el registro. Consecuentemente, para enervar un registro previamente tramitado sí se requiere de la demostración de un riesgo inaceptable. De otra parte, como ya se indicó, la norma es tuitiva de la salud humana y del ambiente, para lo que contempla una potestad de imperio de la administración pública como lo es la restricción o prohibición de uso de un registro, aunque exista una situación jurídica sustancial previa en favor del administrado, como lo es el registro.

IV.-SOBRE LA VIOLACIÓN DE LO PREVISTO EN EL ARTÍCULO 146 DE LA CONSTITUCIÓN POLÍTICA. Tampoco estima la Sala Constitucional que la omisión del Ministro de Salud y, del Ministro del Ambiente, de suscribir el Decreto suponga un vicio de inconstitucionalidad de la normativa cuestionada, habida cuenta que, como lo reconoce la parte actora, el Decreto impugnado ha sido emitido, de manera conjunta, por el Presidente de la República y el Ministro de Agricultura, con lo cual, no se aprecia ninguna afectación de lo dispuesto en el artículo 146 de la Constitución Política, pese a lo que, sobre el particular, reclama el actor. En virtud de lo expuesto, también se debe rechazar, por el fondo, la acción, en lo que atañe a este punto”. (Lo destacado no corresponde al original).

Estas consideraciones son especialmente significativas para el caso concreto, por cuanto deja de manifiesto que para que se deje sin efecto un registro ya autorizado se debe justificar que existe la demostración de un riesgo inaceptable para la salud humana y el ambiente. Asimismo, se enfatizó que la omisión del Ministro de Salud y del Ministro de Ambiente de suscribir el decreto no supone un vicio de inconstitucionalidad de la normativa cuestionada.

Posteriormente, en la sentencia n.°2017-007766, se resolvió lo siguiente:

III.- CASO CONCRETO. Previo a la resolución del presente recurso de amparo, debe indicarse que, la finalidad del recurso de amparo es brindar tutela oportuna contra infracciones o amenazas a los derechos y libertades fundamentales, no la de servir como un instrumento genérico para garantizar el principio de supremacía constitucional o el principio de legalidad. Por esa razón, la Sala no puede erigirse, por su medio, en un contralor en abstracto de la constitucionalidad de las normas infraconstitucionales. De allí que, conforme al numeral 30 inciso a) de la Ley que rige esta jurisdicción, no proceda en este caso el amparo contra leyes u otras disposiciones normativas, salvo cuando se impugnen conjuntamente con los actos de aplicación individual de aquéllas, o cuando se trate de normas de acción automática, en cuyo caso debe acudirse al procedimiento regulado en los numerales 73 y siguientes de la Ley de la Jurisdicción Constitucional. Conforme a los supuestos recién mencionados, no procede en este caso el amparo.

IV.- NOTA DE LOS MAGISTRADOS CRUZ CASTRO Y RUEDA LEAL. Mediante resolución No. 2017006668 de las 10:50 horas del día 10 de mayo de 2017, se rechazó por el fondo una acción de inconstitucionalidad contra el Decreto Ejecutivo No. 39995-MAG, Reglamento para la actualización de la información de los expedientes de registro de ingrediente activo grado técnico y plaguicidas formulados. En dicha sentencia los magistrados Cruz Castro y Rueda Leal salvamos el voto y ordenamos darle curso a la acción, porque estimamos que el tema ameritaba dilucidarlo mediante el procedimiento de acción de inconstitucionalidad.

V.- NOTA SEPARADA DE LA MAGISTRADA HERNÁNDEZ LÓPEZ. Concurro con el voto de mayoría en este recurso de amparo, sin embargo debo dejar expresamente establecido que mi posición fue la de cursar la acción planteada en su momento por los interesados en relación con este tema.- Mis razones fueron las siguientes:

"Desde mi perspectiva el decreto instaura procedimientos para poner al día con las actuales exigencias técnicas, a un grupo de registros de plaguicidas y le asegura a quienes logren cumplir con tales condiciones, no solo un nuevo plazo de autorización (artículo 6), sino la garantía (artículo 7) de que las autoridades estatales no estorbarán su negocio sino cuando puedan demostrar “un riesgo inaceptable para la salud humana, el ambiente o la agricultura.” Leída de este modo, (el propuesto por el accionante) la norma quiere dotar a los dueños de los registros de una garantía frente a acciones del Estado en relación con sus productos, pero a costa –según el recurrente- de sacrificar el principio precautorio que ostenta un rango constitucional.- Estimo que el ordenamiento costarricense, obliga constitucional y convencionalmente al Estado a proteger la salud pública, de tal forma que si una persona acredita de manera razonable, un riesgo cierto, real e inminente a la salud pública en los efectos de un plaguicida registrado, las autoridades estatales tienen el deber de actuar, indistintamente de si ese producto está registrado o no, porque no podría ponerse ese registro por encima de un bien jurídico como la salud pública. La historia tiene documentados sendos ejemplos de palguicidas como el Nemagón o el DDT que no obstante haber pasado las pruebas y filtros que en su momento existían para garantizar su viabilidad, resultaron no ser inocuos para la salud humana.

La norma impugnada está inserta dentro de un marco normativo de protección a nivel constitucional y convencional que obliga a las autoridades- incluso de oficio-, a dictar las medidas cautelares que estimen necesarias cuando razonablemente se establezca una lesión (cierta real e inminente a la salud de los habitantes), de tal manera tal que, la frase “riesgo inaceptable” no es aquél que tenga que comprobar fehacientemente la administración, o que imponga la carga de la prueba al administrado, sino el que -como se indicó supra-, razonablemente se acredite de los hechos concretos, tutela para la cual el ordenamiento jurídico prevé entre otros instrumentos jurídicos, la protección a través del recurso de amparo.

Similarmente, en lo que se refiere al principio precautorio en materia ambiental, este Tribunal Constitucional ha dado importantes pasos, como se aprecia por ejemplo en la doctrina que cabe extraer de la sentencia No. 2004-1923 de las 14:55 horas del 25 de febrero de 2004, en donde se desarrolla con amplitud el postulado de que la certeza científica absoluta no deberá utilizarse como razón para postergar la adopción de medidas eficaces en función de los costos para impedir la degradación del medio ambiente (…)

La sentencia transcrita es vinculante para las autoridades estatales de modo tal, que tanto el derecho a la salud como el principio precautorio en materia ambiental, obligan al Estado a actuar aún ante el mero riesgo, siempre claro está que sea cierto, real e inminente, con lo cual, la norma discutida no podría enervar -y desde mi perspectiva no lo hace-, la obligación de acción del Estado frente a la protección de estos bienes jurídicos, acción que está sustentada en normas constitucionales y convencionales. En ese sentido no creo que la norma tenga, en sí misma, una redacción que choque con los valores indicados, pero si se diera su aplicación en un marco que atente contra los bienes señalados, el ordenamiento jurídico tiene -encima de dicha norma de mero valor reglamentario- los remedios cautelares inmediatos que puede solicitar el administrado en protección de los mismos, entre ellos, el del recurso de amparo.

En consecuencia, por las razones dichas, estimo que la norma, en su contenido, no puede nunca enervar per sé, la obligación constitucional y convencional que tiene el Estado en la protección de la salud y el ambiente” Dejo de esta manera aclarada mi posición en aquel caso y las razones por las que ahora coincido con la mayoría”.

Asimismo, la Sala se refirió a la constitucionalidad del decreto n.°40059-MAG-MINAE-S, “RTCR 484:2016. Insumos Agrícolas, Plaguicidas Sintéticos Formulados, Ingrediente Activo Grado Técnico, Coadyuvantes y Sustancias Afines de uso Agrícola. Registro, Uso y Control”, cuyo objeto era regular el proceso de registro de plaguicidas sintéticos formulados, ingrediente activo grado técnico, coadyuvantes y sustancias afines de uso agrícola del SFE. Su ámbito de aplicación está constituido por las personas físicas o jurídicas que registren, comercialicen, importen, formulen, fabriquen, reenvasen, reempaquen, almacenen, distribuyan y manipulen plaguicidas químicos formulados, ingrediente activo grado técnico, coadyuvantes, sustancias afines, así como los de origen mineral y las sales inorgánicas. Mediante el voto n.°2022-023238 la mayoría desestimó la acción de inconstitucionalidad. De lo dicho, se aprecia que dicha normativa era la aplicable para procesos de inscripción novedosos.

Por otra parte, en el voto n.°2022-026651, este tribunal se refirió a la constitucionalidad del decreto n.°39995-MAG, denominado “Reglamento para la Actualización de la Información de los Expedientes de Registro de Ingrediente Activo Grado Técnico y Plaguicidas Formulados” y, por mayoría, se declaró sin lugar la acción de inconstitucionalidad. Dicho decreto y el que se examina en autos no se refieren concretamente a un proceso de inscripción o registro de plaguicidas nuevos, sino que su regulación es aplicable para productos que ya se encuentran en el mercado, pero cuya inscripción se realizó bajo otros parámetros que no se les exigía el registro previo del IAGT, por lo que el Poder Ejecutivo estimó imprescindible actualizar la información de estos registros y además establecerles un plazo de vigencia igual al de los registros que se otorgan con la normativa actual. Justamente en dicho proceso de constitucionalidad, se explicó que el decreto n.°39995-MAG de 15 de diciembre de 2016 es una normativa diseñada para la actualización de la información de los expedientes de registro de ingrediente activo grado técnico (IAGT) y plaguicidas formulados. La reglamentación busca cumplir con la inscripción de todas las sustancias químicas, biológicas o afines para uso agrícola, de uso antiguo en el registro del SFE. Esto incluye todas aquellas entidades químicas no registradas porque la legislación no lo establecía como requisito obligatorio. De este modo, a partir de este Reglamento, ningún IAGT y/o producto formulado que se comercializa en Costa Rica debería ser desconocido para el Estado, y, mejor aún, dicha normativa busca tener la información actualizada que permite un mejor control. Con ello trae a tiempo presente la información técnica y científica de los registros viejos al asociar los IAGT’s con los registrados por la normativa bajo las cuales se inscribió. De esta manera, abre la posibilidad para que el Estado cuente con la información química confidencial, que se carece en los expedientes de los registros viejos. Partiendo de tales premisas, se van a examinar de seguido los agravios de constitucionalidad formulados en el caso concreto.

VI.- SOBRE COMPETENCIAS LEGALES En primer lugar, el accionante afirma que de este proceso de registro, post registro y reválida o actualización de la información de los plaguicidas deben participar activamente el Ministerio de Salud y el MINAE, pues las sustancias tienen incidencia directa o indirecta en el ambiente en general y consecuentemente en la salud de las personas. Cuestiona, por ello, que el decreto otorga la facultad de que solo el SFE otorgue el registro en forma unilateral, sin la participación de los otros ministerios, lo que a su juicio implica un retroceso en el nivel de protección y una violación al principio de objetivación de la tutela ambiental.

El Ministro de Agricultura y Ganadería explicó, al respecto, que las normas jurídicas y técnicas relativas a la protección fitosanitaria deben ser interpretadas de conformidad con el deber constitucional del Estado y de la sociedad en general de actuar en prevención del riesgo ambiental y de la salud tanto humana como animal, como en efecto se hace al emitir tanto el decreto ejecutivo n.°39995-MAG, como el n.°41481-MAG. Indicó que el legislador le confirió al SFE la competencia para la consecución de los fines contenidos en la Ley de Protección Fitosanitaria y que dicha asignación competencial es exclusiva a dicho órgano, dentro de lo cual cabe la realización y custodia de los registros respectivos. Al efecto, se citan las disposiciones de la Ley de Sanidad Vegetal y la Ley de Protección Fitosanitaria. En esta última expresamente deja establecida la competencia en materia de registro y fiscalización de los plaguicidas de uso agrícola en el SFE.

Sobre el particular, la PGR refirió que el decreto impugnado no incluye la participación del Ministerio de Salud y del MINAE, y, por tanto, arrastra el mismo vicio que el decreto 39995, salvo que la Sala estime que las competencias atribuidas a otros órganos en sus respectivas leyes de creación no quedan derogadas ni modificadas por la norma impugnada, y que el SFE – dentro del ejercicio de sus competencias legales – puede y debe requerir la participación de cualquier organismo técnico especializado para verificar que un plaguicida no atente contra la salud y el ambiente.

Al respecto, no observa la Sala que configure de forma específica una lesión al Derecho de la Constitución. El hecho de que el legislador ordinario haya decidido concentrar las competencias de la protección fitosanitaria en una autoridad específica de creación legal como lo es el SFE, adscrito al MAG, no implica de modo alguno una lesión a alguna disposición de nuestra Constitución Política. Corresponde a una decisión de diseño orgánico y competencial específico que es de libre configuración del legislador y que, por lo demás, no deja sin efecto la rectoría que pueda tener el Ministerio de Salud o el MINAE en las materias propias de su competencia. Al respecto, el legislador dispuso amplias competencias a favor del SFE en lo relativo justamente a la protección fitosanitaria. Al efecto, el art. 5 de la Ley de Protección Fitosanitaria, n°7664 establece lo siguiente:

“ARTICULO 5.- Funciones y obligaciones El Servicio Fitosanitario del Estado tendrá las siguientes funciones:

• a)Velar por la protección sanitaria de los vegetales.
• b)Asesorar en materia de protección fitosanitaria y recomendar la emisión de las normas jurídicas necesarias en este campo.
• c)Coordinar con otros ministerios y sus dependencias, las acciones pertinentes para el cumplimiento de esta Ley y sus Reglamentos. Será órgano coadyuvante y auxiliar de la Dirección General de Aduanas del Ministerio de Hacienda, en la fiscalización y el control de los internamientos y valores de las mercancías o de los productos de carácter agropecuario.

(Así reformado por artículo 3° de la Ley No. 8373 de 18 de agosto de 2004).

• d)Elaborar, recomendar, coordinar, ejecutar y difundir los reglamentos y las disposiciones que garanticen la aplicación de esta ley.
• e)Disponer y ejecutar las medidas técnicas, legales y administrativas para evitar, prevenir y retrasar la introducción o el establecimiento de nuevas plagas en los vegetales.
• f)Erradicar, controlar o retardar la propagación de plagas ya introducidas.
• g)Realizar el control fitosanitario del intercambio, nacional e internacional, de vegetales, de agentes de control biológico y otros tipos de organismos usados en la agricultura, materiales de empaque y acondicionamiento, y medios de transporte capaces de propagar o introducir plagas que amenacen la seguridad alimentaria y la actividad económica en que se basa la producción agrícola.
• h)Formular, ejecutar y supervisar los programas de reconocimiento y detección de plagas, así como los planes de emergencia.
• i)Estudiar y diagnosticar el estado fitosanitario del país.
• j)Establecer y mantener actualizado un sistema nacional de información respecto del estado fitosanitario.
• k)Declarar, oficialmente, la presencia de plagas y su importancia cuarentenal.
• l)Evaluar y regular, en el área de la fitoprotección, cualquier método de producción.
• m)Organizar, avalar o no avalar y apoyar la elaboración, difusión y aplicación de los programas para la prevención y el combate de plagas existentes.
• n)Promover y controlar el manejo integrado de plagas y las metodologías apropiadas que se utilicen.
• ñ)Controlar la calidad fitosanitaria del material de propagación.
• o)Controlar las sustancias químicas, biológicas o afines para uso agrícola, en lo que compete a su inscripción, importación, exportación, calidad, tolerancia, residuos, dosificaciones, efectividad, toxicidad, presentación al público, conservación, manejo, comercio, condiciones generales de uso, seguridad y precauciones en el transporte, almacenamiento, eliminación de envases y residuos de tales sustancias; asimismo, controlar los equipos necesarios para aplicarlas y cualquier otra actividad inherente a esta materia.
• p)Controlar la calidad fitosanitaria de los vegetales de exportación para expedir los certificados fitosanitarios, de conformidad con los tratados internacionales vigentes sobre la materia, esta ley y sus reglamentos.
• q)Regular, en el área de la fitoprotección, la importación, exportación, investigación, experimentación, movilización, multiplicación, producción industrial, comercialización y el uso de materiales transgénicos y otros organismos genéticamente modificados para uso agrícola o sus productos.
• r)Promover, apoyar y avalar la investigación científica fitosanitaria que se requiera.
• s)Gestionar el apoyo técnico y financiero de organismos nacionales e internacionales para fortalecer el Servicio Fitosanitario del Estado.
• t)Recomendar, al Poder Ejecutivo, el nombramiento ad honórem de autoridades fitosanitarias.
• u)Velar por la administración, el control y uso de los recursos obtenidos al aplicar esta ley.
• v)Brindar, previo convenio, capacitación, asesoramientos y consultorías en materia de protección fitosanitaria.
• x)Promover la armonización internacional de las medidas fitosanitarias.

Los controles que menciona este artículo podrán realizarse en forma total o aleatoria, según se establezca mediante criterios técnicos”. (Lo destacado no corresponde al original).

De lo anterior se desprende que la competencia de “controlar las sustancias químicas, biológicas o afines para uso agrícola, en lo que compete a su inscripción” le fue expresamente asignada por parte del legislador al SFE, sin perjuicio ‒como lo dispone el mismo artículo‒ de coordinar, con otros ministerios y sus dependencias, las acciones pertinentes para el cumplimiento de esta la ley y sus reglamentos.

Además, la ley expresamente establece que las sustancias deberán inscribirse en el registro que justamente corresponde crear y custodiar al SFE y también dispone las consecuencias por no ajustarse al procedimiento:

“Art. 23. Inscripción de sustancias y equipos.

Según los requisitos que se señalarán en el reglamento de esta ley, todas las sustancias químicas, biológicas o afines y los equipos de aplicación para uso agrícola, deberán inscribirse en el registro que el Servicio Fitosanitario del Estado creará para disponer de información sobre las características de estos y velar por su correcta utilización en el país.

Art. 24.- Registro de sustancias Ninguna persona física o jurídica podrá importar, exportar, fabricar, formular, almacenar, distribuir, transportar, reempacar, reenvasar, anunciar, manipular, mezclar, vender ni emplear sustancias químicas, biológicas o afines para uso agrícola, que no estén registradas conforme a la presente ley. (…)” Es exigido, claro está, que estas competencias deben cumplirse en el marco de los derechos constitucionales a la salud y a un medio ambiente sano, y que las autoridades del SFE en todos los casos deben velar por tales derechos.

Al respecto, es preciso enfatizar que este Tribunal en la sentencia n.°2022-023238 ya estableció que, pese a que los registros están bajo la competencia del SFE, los otros ministerios señalados tienen la posibilidad de advertir, dentro del área de sus competencias, de la existencia de materiales prohibidos o sujetos a nuevas restricciones de conformidad con las regulaciones internacionales que caen bajo tales competencias. Se advirtió que este tipo de normativa no implica que las demás funciones de los dos ministerios queden disminuidas y que estos no puedan ejercer una activa participación y colaboración, previa al otorgamiento del registro o en la función de vigilancia, cuando un registro incumple con las obligaciones internacionales por el uso de productos prohibidos internacionalmente; por ejemplo, los estándares internacionales de riesgos inaceptables para la salud y el medio ambiente (ver sentencia n.°2022-023238). Incluso, en el informe rendido en el expediente n.°18-009107-0007-CO, la PGR señaló lo siguiente:

“[L]a posible flexibilización del procedimiento de registro de plaguicidas que hizo el decreto n.°40059-MAG-MINAE-S en procura de dar mayor acceso al sector agrícola de productos o insumos de menor costo, no puede ir en detrimento de la competencia legal de los órganos técnicos del MAG, MINAE y el MINSA para requerir la información que estimen pertinente y determinar mediante evaluaciones y análisis rigurosos de datos que los agroquímicos solicitados resultan inocuos para la salud de las personas y el ambiente”. (Lo destacado no corresponde al original).

Por lo demás, debe observarse que las críticas realizadas por el accionante ‒a la luz de las consideraciones de la CGR‒ tenían un contexto normativo diferente, pues precisamente atendiendo a dichas recomendaciones y omisiones fue que expresamente se adoptó una medida transitoria en el decreto ejecutivo n.°40059 “Reglamento Técnico: “RTCR 484:2016. Insumos Agrícolas. Plaguicidas Sintéticos Formulados, Ingrediente Activo Grado Técnico Coadyuvantes y Sustancias Afines de Uso Agrícola. Registro, Uso y Control”, vigente a partir del 13 de julio de 2017, que tiende justamente a dotar al MAG y al SFE de instancias técnicas idóneas para resolver todo lo relativo a los registros de agroquímicos y establece expresamente que dicha instancia debe operar “sin perjuicio de las competencias constitucionales o legales que correspondan a los Ministerios de Salud o Ambiente”:

“TRANSITORIO QUINTO: El Ministerio de Agricultura y Ganadería establecerá dentro de su estructura , en un plazo de doce meses a partir de la vigencia del presente decreto, las Áreas de Evaluación: química, agronómica, toxicológica y la ecotoxicológica, como parte de la Unidad de Registro de Agroquímicos y Equipos de Aplicación, y que tendrán a su cargo la revisión, verificación de cumplimiento de requisitos, evaluación y calificación de los documentos y estudios toxicológicos y ecotoxicológicos y de destino ambiental, que establezca este reglamento en las diferentes modalidades de registro, sin perjuicio de las competencias constitucionales o legales que correspondan a los Ministerios de Salud o Ambiente”. (Lo destacado no corresponde al original).

En consecuencia, corresponde a las autoridades técnicas nacionales, de acuerdo con las amplias facultades otorgadas por el ordenamiento jurídico, realizar el procedimiento de actualización de la información de los expedientes de registro de ingrediente activo grado técnico y plaguicidas formulados con sumo rigor y cuidado en aras de velar por los derechos fundamentales a la salud y a un medio ambiente sano de todos los habitantes. De esta manera, la responsabilidad última en la decisión sobre si procede o no autorizar la solicitud de actualización de los productos compete a las autoridades nacionales. En tal sentido, en la sentencia n.°2022-023238 se concluyó que en cada petición específica ‒en el caso concreto se refiere a la actualización de la información de los expedientes de registro de ingrediente activo grado técnico y plaguicidas formulados‒, corresponde a nuestras autoridades nacionales estar vigilantes en relación con los estudios que se les someten a valoración, y no implica, de modo alguno, una autorización para que se relajen en el trámite y vigilancia que es preciso llevar a cabo.

Sobre este punto cabe añadir que, aunque tuviéramos los estándares normativos más altos, ello por sí mismo no sería suficiente si las autoridades nacionales no ejercen de forma responsable las competencias que les atañen. En ese sentido, una desestimatoria del agravio no supone que se esté avalando que las autoridades no estén vigilantes a priori y a posteriori. Por el contrario, esta Sala entiende que, incluso, ante el menor vestigio de duda, deben proceder a requerir toda la documentación o estudios que sean pertinentes, con el propósito de verificar que el producto sobre el que se va a actualizar el registro cumple con los parámetros y condiciones necesarias para resguardar la salud humana. Asimismo, les corresponde velar porque su uso sea el apropiado y tenga los efectos deseados. Tan importante es el rigor en la selección de los estudios, como los controles posteriores que puedan ser llevados a cabo en la aplicación y uso de los productos.

Es oportuno citar las reflexiones que realizó esta Sala en la sentencia n.°2011-016937, a propósito de conocer de otras regulaciones tendientes a la inscripción de plaguicidas:

“VII.- SOBRE LA REDUCCIÓN DE LOS RIESGOS PARA LA SALUD Y EL AMBIENTE, CONFORME A LO DISPUESTO EN EL ARTÍCULO 5 CÓDIGO INTERNACIONAL DE CONDUCTA PARA LA DISTRIBUCIÓN Y UTILIZACIÓN DE PLAGUICIDAS. Resulta de interés remitir a lo dispuesto en el citado Código Internacional de Conducta para la Distribución y Utilización de Plaguicidas, que fue adoptado, por primera vez en 1985, por la vigésima quinta sesión de la conferencia de la Organización de las Naciones Unidas para la Agricultura y la Alimentación (FAO). Según se explica en el prefacio de la versión revisada (adoptado por el 123º periodo de sesiones del Consejo de la FAO, noviembre 2002), dicho código de conducta fue adoptado y ha sido revisado con el propósito de conseguir una mayor seguridad alimentaria y, al mismo tiempo, proteger la salud humana y el medio ambiente. Para tales efectos se establecen estándares de conducta que han de servir como marco y punto de referencia para el uso adecuado y racional de los plaguicidas, que se centran en la reducción del riesgo, la protección de la salud humana y ambiental y el apoyo al desarrollo de la agricultura sostenible mediante el uso eficaz de los plaguicidas [fuente: (Fuente: http://www.fao.org/agriculture/crops/core-themes/theme/pests/pm/code/en/(05/08/11)] (…)

VIII.- SOBRE LA REGULACIÓN EN MATERIA DE REGISTRO DE LOS PLAGUICIDAS. El uso adecuado de los plaguicidas puede resultar útil para el control y eliminación de las plagas, en beneficio de la seguridad alimentaria de la población y de la actividad económica sustentada en la producción agrícola. Sin embargo, debe reconocerse el riesgo potencial que puede implicar para la salud humana y el ambiente el uso de tales sustancias. Lo que incluso ha motivado la adopción de instrumentos internacionales con el objetivo expreso de proteger la salud humana -incluida la salud de los consumidores y de los trabajadores- y el medio ambiente frente a los posibles efectos perjudiciales de los plaguicidas, como es el caso del Convenio de Rotterdam para la Aplicación del Procedimiento de Consentimiento Fundamentado Previo a Ciertos Plaguicidas y Productos Químicos Peligrosos Objeto del Comercio Internacional, que fue aprobado por Costa Rica, por medio de Ley No. 8705 del 13 de febrero del 2009. En cuyo caso, ante la consulta legislativa preceptiva de constitucionalidad planteada ante este Tribunal (expediente número 08-015252-0007-CO), de previo a la aprobación de dicho instrumento internacional, este Tribunal señaló- en lo que interesa- que:

“(…) el Estado costarricense está en el deber de actuar en forma eficaz y anticipada, para evitar la ocurrencia de eventos que degraden el medio ambiente y comprometan su sostenibilidad. Desde esa perspectiva, que se comprometa, a través de un tratado internacional como el consultado, o mediante un acto interno, a facilitar la utilización racional de los productos químicamente peligrosos objeto de comercio internacional, no solamente es posible, sino totalmente acorde con sus deberes constitucionales. Los plaguicidas y los productos químicos industriales son sustancias que pueden causar daños a la salud humana y en el ambiente. Ante tal amenaza, el Convenio de Rotterdam proporciona a las Partes la posibilidad de conocer de antemano la composición y los efectos de algunos productos químicos, los cuales son expresamente señalados en su Anexo III. Las medidas idóneas que el Estado tome para regular la comercialización y el empleo de dichos productos en actividades industriales, agrícolas, etc. resultan conformes con su deber de preservar los mencionados valores de rango constitucional. De ahí que los deberes que asumiría el Estado en caso de aprobar definitivamente este Convenio resultan legítimos, conforme al Derecho de la Constitución. Se estaría ante una decisión soberana del Estado de someterse a las obligaciones contenidas en el Convenio, para contribuir a la protección de la salud de las personas y la integridad del medio ambiente, por lo que se puede concluir que, en términos generales, de las cláusulas del Convenio de Rotterdam, cuya aprobación es sometido a consulta, no se observan vicios de inconstitucionalidad.” (resolución número 2008-018207 de las 18:15 horas del 10 de diciembre del 2008) Con lo que se verifica que este Tribunal ha reconocido el riesgo que puede entrañar el uso de los plaguicidas y la trascendencia de adoptar medidas idóneas para regular su empleo. En el ordenamiento jurídico costarricense existe diversa normativa legal y reglamentaria de la que se deriva que la actividad de importación, fabricación, comercialización y empleo de los plaguicidas está fuertemente sometida a la potestad de policía del Estado, en aras de garantizar el derecho a la salud y al medio ambiente sano y ecológicamente equilibrado. Se puede citar, en primer lugar, la Ley General de Salud, que en su artículo 213 dispone:

“ARTICULO 213.- Toda persona, natural o jurídica, que se ocupe en producir alimentos, deberá hacerlo en condiciones ambientales sanitarias y empleando técnicas de defensa o conservación aprobadas por la autoridad de salud, a fin de evitar, principalmente, la contaminación de tales productos y su peligrosidad debida a la presencia de residuos tóxicos proveniente de su tratamiento con plaguicidas u otros sistemas de defensa o conservación.” Mientras que en el artículo 244 de ese mismo cuerpo normativo se establece:

“ARTICULO 244.- Las personas naturales y jurídicas que importen, fabriquen, manipulen, almacenen, transporten, comercien, suministren o apliquen sustancias, mezclas de sustancias o productos denominados plaguicidas por la ley de sanidad vegetal, quedarán sujetas a las disposiciones reglamentarias que el Ministerio dicte de común acuerdo con el Ministerio de Agricultura para el resguardo de la salud de las personas de conformidad con esa ley, los interesados deberán registrar todo pesticida o producto destinado al control o exterminio de las infestaciones y solicitar permiso previo para operar cuando tales sustancias, mezclas de sustancias o productos que por su naturaleza o uso no queden incluidos en la ley mencionada fueren capaces de algún modo de producir intoxicaciones o daños serios a la salud de las personas o de los animales útiles o inofensivos al hombre.” Por su parte, mediante la Ley de Protección Fitosanitaria (Ley No. 7664 de 8 de abril de 1997) se declaró de interés público y aplicación obligatoria, las medidas de protección fitosanitaria establecidas en esa ley y sus reglamentos (art. 1). Además, dentro de los objetivos de dicha ley se incluye: “Regular el uso y manejo de sustancias químicas, biológicas o afines y equipos para aplicarlas en la agricultura; asimismo, su registro, importación, calidad y residuos, procurando al mismo tiempo proteger la salud humana y el ambiente” (artículo 2, inc. e). La autoridad competente en la materia es el Servicio Fitosanitario del Estado, al que le corresponde –entre otras funciones-: “Controlar las sustancias químicas, biológicas o afines para uso agrícola, en lo que compete a su inscripción, importación, exportación, calidad, tolerancia, residuos, dosificaciones, efectividad, toxicidad, presentación al público, conservación, manejo, comercio, condiciones generales de uso, seguridad y precauciones en el transporte, almacenamiento, eliminación de envases y residuos de tales sustancias; asimismo, controlar los equipos necesarios para aplicarlas y cualquier otra actividad inherente a esta materia” (artículo 5, inc. o).

(…)

Se desprende de la normativa previamente citada que, como manifestación del referido poder de policía, se incluye el necesario registro de plaguicidas de previo a autorizar su importación, fabricación, comercialización o empleo, a fin de poder ejercer un control previo en cuanto al debido cumplimiento de los correspondientes requerimientos técnicos de calidad y seguridad, en protección de la salud pública y el medio ambiente”.

Dichas consideraciones resultan de aplicación en el sub lite, esto es, que el ordenamiento jurídico interno contempla variadas normativas y competencias a favor de las autoridades técnicas nacionales a efecto de que, en uso de ese poder de policía, permanezcan vigilantes y garanticen la calidad y el beneficio de los productos de plaguicidas cuyos registros se pretenden actualizar y, en definitiva, que se resguarden así los derechos de todas las personas.

Al respecto, tal y como se verá infra en detalle, la normativa impugnada no está diseñada para la inscripción de productos plaguicidas nuevos, sino para actualizar los registros de productos que ya están inscritos y son de libre comercialización en el mercado nacional. Ante la menor duda de que el plaguicida debidamente registrado (ya sea como IAGT o plaguicida formulado) cause un daño o una amenaza a la salud o al medio ambiente, todas las autoridades nacionales, incluido el Ministerio de Salud o el MINAE, tienen sus propias atribuciones y competencias para instaurar los procedimientos que correspondan a efecto de impedir la importación, fabricación, manipulación, comercialización o uso del producto. Es más, de ser preciso, pueden dictar las medidas cautelares que sean necesarias para resguardar los bienes jurídicos en mención. Justamente, el principio precautorio ‒que es invocado por el accionante‒ debe inspirar todas las conductas de control a priori y posteriori de todas las autoridades públicas en mención y, si en algún caso en concreto se sospecha o se tiene evidencia de los daños o las amenazas a la salud pública o al medio ambiente, están en la obligación constitucional de adoptar las medidas preventivas que correspondan.

Se debe hacer eco de lo ya indicado en la sentencia n.°2017-06668, en lo relativo la constitucionalidad del decreto ejecutivo n.°39995-MAG, y que también resulta aplicable a este decreto, puesto que el hecho de que los Ministros de Salud y Ambiente y Energía no hayan suscrito el decreto no supone un vicio de inconstitucionalidad de la normativa cuestionada porque ha sido emitido, de manera conjunta, por el Presidente de la República y el Ministro de Agricultura, con lo cual, no se aprecia ninguna afectación de lo dispuesto en el art. 146 de la Constitución Política.

Finalmente se reitera que, a la luz de lo dispuesto en el art. 10 de la Ley General de la Administración Pública (LGAP) ‒la norma administrativa deberá ser interpretada en la forma que mejor garantice la realización del fin público a que se dirige‒, esta normativa especial debe ser aplicada e interpretada de manera integral con lo dispuesto en el ordenamiento jurídico sobre la materia (leyes de interés público mencionadas supra). Es decir, en modo alguno puede entenderse que lo impugnado constituye un cuerpo normativo aislado del resto del bloque de legalidad y de constitucionalidad, y que la labor específica de actualizar la información de los registros suponga anular el resto de competencias legales confiadas a otras carteras ministeriales.

En virtud de lo expuesto, a partir de las consideraciones realizadas, esta Sala no logra acreditar las supuestas lesiones al principio precautorio que le son atribuidas al decreto, solo por el hecho de que sea suscrito por el MAG y porque las competencias de actualización del registro estén concentradas en el SFE. Como se examinó, tales competencias son potestades de imperio otorgadas por el propio legislador (art. 59 LGAP) que no deja sin efecto las demás disposiciones legales de interés público en la materia.

VII.- SOBRE EL TRÁMITE QUE REGULA LA NORMATIVA IMPUGNADA El accionante insiste que en estos procesos deben intervenir el Ministerio de Salud y el MINAE aún más cuando en este caso que no es una simple actualización, sino que es un análisis científico de la información presentada por el registrante para realizar la respectiva evaluación de riesgo.

En este punto, el Ministro de Agricultura y Ganadería explica que el decreto de actualización de expedientes y su reforma se aplica exclusivamente a todos los registros de “ingrediente activo grado técnico” (IAGT) y productos formulados que fueron inscritos con una normativa (legal o reglamentaria) distinta al decreto ejecutivo n.°33495-MAG-S-MEIC-MINAET, “Reglamento sobre Registro, Uso y Control de Plaguicidas Sintéticos Formulados, Ingrediente Activo Grado Técnico, Coadyuvantes y Sustancias Afines de Uso Agrícola”. Es decir, enfatiza que solo aplica para aquellos expedientes de registro de productos que ya están en el mercado y que fueron registrados conforme a la normativa aplicable al momento de su aprobación y que eran evaluados integralmente (salud, ambiente y eficacia biológica) conforme a esa normativa. Aduce que la parte accionante confunde y pretende confundir respecto de los agroquímicos registrados y que se comercializan actualmente en el país, que es a los que se les aplica el decreto ejecutivo n°39995-MAG y n.°41481-MAG, pretendiendo hacer creer que deben ser nuevamente evaluados, lo que no resulta procedente ni necesario, pues todos los productos inscritos en Costa Rica cumplieron con los requisitos y normativa establecida en el derecho positivo vigente al momento de otorgarse dichos registros. En consecuencia, aclara vehemente que en ninguno de los productos plaguicidas, sean materias primas o productos formulados que cuentan con registro vigente, existe evidencia o presunción técnica científica, o al menos indicios, que presuman un peligro adicional o resultante de la aplicación del mismo, en cuanto a la salud humana, el ambiente o la eficacia biológica del plaguicida. Tanto la Sala Constitucional como la PGR han sido claros en el sentido de que tanto el Ministerio de Salud, el de Ambiente, el de Agricultura o hasta particulares, pueden acudir a la sede jurisdiccional ordinaria a solicitar la anulación de los actos administrativos mediante los cuales se otorgaron esos registros, e incluso, pueden solicitar que precautoriamente se suspenda su comercialización. Sin embargo, ni el Ministerio de Salud, ni el de Ambiente, ni el accionante lo hacen porque carecen de pruebas, sustento científico y técnico para hacerlo y, por eso, entiende que el accionante acude temerariamente a la Sala Constitucional a plantear temas de legalidad mediante acciones de inconstitucionalidad, que el único fin y objetivo que tienen es entorpecer el proceso de ordenamiento del sistema de registros de agroquímicos que emprendió la Administración.

Insiste que con los decretos mencionados ‒n°39995-MAG y n.°41481-MAG‒ no se están otorgando registros de IAGT o para plaguicidas formulados nuevos, sino que solo aplica a IAGT (materias primas) y formulados viejos. Al respecto, explica que fue a partir del 2007 que se estableció un sistema de registro que obliga a registrar previamente la materia prima ‒IAGT‒. Antes de esa fecha no era necesario registrar el IAGT y por ello es que el Poder Ejecutivo emitió los decretos bajo impugnación. Alega que no es como lo indica la parte accionante, que mediante las normas impugnadas se esté facilitando el registro de nuevos productos, pues lo cierto es que no se facilita nada, sino que se abre un espacio para que los titulares de los registros hagan llegar la información química confidencial, que es fundamental para garantizar que no hay impurezas relevantes desde el punto de vista toxicológico y ecotoxicológico en alguno de los productos que se comercializan actualmente en el mercado en virtud de un registro vigente, otorgado a plazo indefinido. Por tanto, sostiene que no es correcto afirmar que con la aplicación de estas normas los registros que se actualicen en sus expedientes suponen un riesgo adicional para la salud, el ambiente o la agricultura, pues todos los registros de IAGT que se otorguen, necesaria e indefectiblemente, deben corresponder a alguna de las formulaciones que ya se venden en el mercado, y sobre estas formulaciones los Ministerios de Salud o Ambiente tienen amplias e indiscutibles competencias y facultades para adoptar las medidas pertinentes con el fin de evitar un daño a la salud o al ambiente.

Apunta que el decreto ejecutivo n.°39995-MAG y su reforma n.°41481-MAG permite resolver los problemas de desorden, incertidumbre y falta de información en los expedientes de registro que amparan las inscripciones de los IAGT y plaguicidas formulados con registro vigente, pero que fueron otorgados con una normativa distinta al decreto ejecutivo n.°33495-MAG-S-MINAE-MEIC. Estima que la normativa cuestionada es un gran avance y resuelve un problema que inició en el año 2004 y que aún no había sido resuelto por las anteriores administraciones, pues tiene previstas las alternativas y vías para resolver los dos problemas más graves que aquejan al sistema de registros de nuestro país: por un lado, la parálisis en registro de productos nuevos y genéricos y, por otro, la imposibilidad de renovar los registros de formulaciones que actualmente están en el mercado.

En ese sentido detalla que la normativa impugnada permite: a) la actualización de los fabricantes, su origen, sitios de producción de los IAGT asociados a las formulaciones que ya se comercializan en Costa Rica y que fueron registrados con legislación distinta; b) lo mismo en relación con los plaguicidas formulados; c) acabar con la incertidumbre jurídica respecto de la vigencia de los registros IAGT y plaguicidas formulados que fueron registrados con legislación y normativa previa, uniformando el plazo de vigencia de diez años para todos los registros y eliminando de este modo con la vigencia indefinida. Explica, en consecuencia, que se allega al expediente de registro exigido en el art. 23 de la Ley de Protección Fitosanitaria toda la información química requerida para poder tomar decisiones respecto del producto en lo que atañe a su seguridad y eficacia y poniendo coto a los registros a plazo indefinido.

Al tramitarse el recurso de amparo n.°17-002503-0007-CO el entonces Ministro del MAG informó bajo la gravedad de juramento ante esta Sala lo siguiente:

“en cuanto a la fundamentación que da origen a la promulgación del Decreto Ejecutivo, No. 39995-MAG, la encontramos en los 7 considerandos, de los cuales los 6 primeros dan la fundamentación legal, en este caso la a Ley de Protección Fitosanitaría No. 7664 que tiene como objeto regular el uso y manejo de sustancias químicas, biológicas o afines y equipos para aplicarlas en la agricultura; asimismo, su registro, importación, calidad y residuos, procurando al mismo tiempo proteger la salud humana y el ambiente, todas las que deberán inscribirse en el registro que el Servicio Fitosanitario del Estado creará para disponer de información sobre las características de estos y velar por su correcta utilización en el país. Los plaguicidas de uso agrícola son fundamentales para el combate de plagas que afectan la Producción agropecuaria y para la competitividad de los productores agrícolas, por ello resulta esencial garantizar el abastecimiento y la continuidad en la comercialización de los productos que, actualmente, cuentan con registro vigente siendo necesario actualizar la información en sus expedientes sobre las características de estos y velar por su correcta utilización en el país. Es precisamente este considerando el que resume el objeto del decreto bajo análisis. El decreto indica en su considerando 4 que las reglamentaciones anteriores a la vigencia del decreto ejecutivo N° 33495 MAG-S-MENAE-ME1C del 31 de octubre de 2006 y sus reformas, permitían, al Ministerio de Agricultura y Ganadería, otorgar los registros a plazo indefinido así como la inscripción de los plaguicidas formulados sin que fuese requisito contar con registro previo del ingrediente activo grado técnico (IAGT), lo que obliga dentro de las facultades constitucionales y legales del Poder Ejecutivo organizar su registro, ordenando la actualización de la información de los registros inscritos sin plazo al haber sido otorgados con una normativa anterior a la que rige el registro actual. El decreto recurrido lo que pretende es actualizar los expedientes con la información que al momento de su registro no se solicitó y contar con información actualizada, mediante un proceso de re registro acorde al artículo 50 Constitucional de tal forma que el Estado procurará el mayor bienestar a todos los habitantes del país, organizando y estimulando la producción y el más adecuado reparto de la riqueza, garantizando un ambiente sano y ecológicamente equilibrado. El Estado garantizará, defenderá y preservará ese derecho lo cual se garantiza con el decreto ya que, si bien se estimula la producción, eso no obsta que se proteja el ambiente y la salud y la vida, ninguno de los cuales puede ponerse en riesgo, motivo por el cual el Ministerio de Agricultura y Ganadería tiene la potestad legal de administrar el registro que se le asignó por ley y para lo cual como mínimo debe actualizar los expedientes como parte de su organización interna. Los registros otorgados con anterioridad al Decreto Ejecutivo N° 33495-MAGS- MINAE-MEIC del 31 de octubre de 2006 y sus reformas, fueron otorgados sin plazo, lo que obliga al Ejecutivo a un análisis de esos registros solicitando a cada registrante la información que se establece en el Decreto que nos ocupa para actualizar el registro y por ende la información, de tal forma que los registrantes puedan registrar acorde con las exigencias de la normativa actual, garantizando al mismo tiempo la continuidad de su comercialización, dada su importancia como herramienta para el combate de las plagas agrícolas y estimulando asimismo la producción que le ha encomendado por ley al Ministerio de Agricultura y Ganadería, sin detrimento de las otras garantías constitucionales como son la vida y un ambiente sano, eso sí sin que se perjudique la producción, en el tanto no afecte la vida. Por la naturaleza de la normativa emitida no se está ante un Reglamento técnico sino ante una actualización de registros vigentes por lo que no se requiere del procedimiento de reglamentación técnica, no obstante la normativa se subió a la página del MEIC, según consta del expediente administrativo adjunto, llenando el Formulario de Evaluación Costo Beneficio en la Sección 1, denominada Control Previo de Mejora Regulatoria, siendo que el mismo dio resultado negativo y estuvo a disposición de la ciudadanía por ser una página de libre acceso. El decreto, en síntesis dispone que los titulares de los registros de los Ingredientes Activos Grado Técnico (IAGT) y de los productos formulados que no cuentan con registro de IAGT, y que no hayan sido inscritos conforme al Decreto Ejecutivo N° 33495-MAG-S- MINAE-MEIC del 31 de octubre de 2006 y sus reformas, deberán actualizar el o los fabricantes de sus IAGT's, en un plazo de veinticuatro meses contados a partir de la entrada en vigencia de este decreto; aportando al Servicio Fitosanitario del Estado la información que ahí se indica para actualización de fabricante, remitiendo además a lo dispuesto en el Reglamento Técnico Centroamericano No. RTCA 65.05.67.13: Insumos Agrícolas. Ingrediente Activo Grado Técnico, Plaguicidas Químicos Formulados, Sustancias Mines, Coadyuvantes y Vehículos Físicos de Uso Agrícola. Requisitos para la elaboración de etiquetas y panfletos. Resolución No. 365-2015 (COMIECO LXXII). Para el caso de los plaguicidas formulados cuyo IAGT no se encuentre registrado, y cuyo expediente ha sido actualizado el Servicio Fitosanitario del Estado le otorgará, en un plazo no mayor de tres meses, contados a partir de la fecha en que se le aprobó la actualización, el correspondiente registro de IAGT. El decreto establece expresamente que los registros de IAGT otorgados, conforme al decreto no podrán ser utilizados como perfil de referencia bajo la modalidad de registro por equivalencia, salvo que haya aportado la data completa. El artículo 7 hace referencia a las potestades legales que las diferentes leyes le otorgan al Ministerio de Salud y del Ambiente, no así a la administración del registro que es lo que pretende la regulación, ya que la potestad de los Ministerios de Salud, Ambiente y Agricultura para restringir o prohibir un uso de un plaguicida es independiente del decreto de referencia. Con fundamento en el informe rendido y el expediente administrativo, así como la letra del decreto impugnado se tiene que el Decreto persigue la organización interna de la Oficina de Registro del SFE, como órgano de desconcentración mínima del Ministerio de Agricultura y Ganadería. Solicita declarar sin lugar en todos sus extremos el presente recurso de amparo.”.

Al respecto, considera la Sala necesario aclarar los alcances de la normativa impugnada en la acción n.°18-019039-0007-CO (relativa al decreto ejecutivo n.°39995-MAG) y la que se conoce en esta acción (relativa al decreto ejecutivo n.°41481-MAG).

Para lo anterior, corresponde citar la parte considerativa o el preámbulo de ambos decretos, pues ofrecen una importante luz sobre los objetivos de las normas en cuestión. El “Reglamento para la actualización de la información de los expedientes de registro de ingrediente activo grado técnico y plaguicidas formulados, n.°39995-MAG”, parte de las siguientes premisas:

“1°-Que uno de los objetivos de la Ley de Protección Fitosanitaria es regular el uso y manejo de sustancias químicas, biológicas o afines y equipos para aplicarlas en la agricultura; asimismo, su registro, importación, calidad y residuos, procurando al mismo tiempo proteger la salud humana y el ambiente.

2°-Que la Ley de Protección Fitosanitaria establece expresamente que todas las sustancias químicas, biológicas o afines y los equipos de aplicación para uso agrícola, deberán inscribirse en el registro que el Servicio Fitosanitario del Estado creará para disponer de información sobre las características de estos y velar por su correcta utilización en el país.

3°-Que los plaguicidas de uso agrícola son fundamentales para el combate de plagas que afectan la Producción agropecuaria y para la competitividad de los productores agrícolas, por ello resulta esencial garantizar el abastecimiento y la continuidad en la comercialización de los productos que actualmente cuentan con registro vigente siendo necesario actualizar la información en sus expedientes sobre las características de estos y velar por su correcta utilización en el país.

4°-Que las reglamentaciones anteriores a la vigencia del decreto ejecutivo N° 33495 MAG-S-MINAE-MEIC del 31 de octubre de 2006 y sus reformas, permitían, al Ministerio de Agricultura y Ganadería, otorgar los registros a plazo indefinido así corno la inscripción de los plaguicidas formulados sin que fuese requisito contar con registro previo del ingrediente activo grado técnico (IAGT), por lo que resulta necesario actualizar la información de estos registros y además establecerles un plazo de vigencia igual al de los registros que se otorgan con la normativa actual.

5°-Que las normativas internacionales establecen requisitos de información toxicológica, ecotoxicológica y de destino ambiental indicados en el decreto ejecutivo N° 33495-MAGS- MINAE-MEIC del 31 de octubre de 2006 y sus reformas, los cuales no se solicitaban en normativas anteriores, por lo cual se hace necesario prorrogar los registros otorgados antes de dicho decreto ejecutivo, para que puedan entrar en un proceso de registro acorde con las exigencias de la normativa actual, garantizando al mismo tiempo la continuidad de su comercialización, dada su importancia como herramienta para el combate de las plagas agrícolas.

6°-Que tanto la Organización de Naciones Unidas para la Alimentación y la Agricultura (FAO) corno la Organización Mundial de la Salud (OMS) reconocen que la generación repetitiva de los estudios e información respecto de todos los riesgos potenciales/reales para cada fabricante de un plaguicida puede ser innecesaria y éticamente no deseable.

7°-Que se procedió a llenar el Formulario de Evaluación Costo Beneficio en la Sección 1, denominada Control Previo de Mejora Regulatoria, siendo que el mismo dio resultado negativo y que la propuesta no tiene tramites ni requisitos.” Mientras que las premisas de la “Reforma Reglamento para la actualización de la información de los expedientes de registro de ingrediente activo grado técnico y plaguicidas formulados”, n.°41481 – MAG, son las siguientes:

“CONSIDERANDO 1.- Que mediante Decreto Ejecutivo No. N° 39995-MAG de 15 de diciembre del 2016, publicado en la Gaceta No. 11, Alcance No. de 16 de enero del 2017 se decreta el Reglamento para la actualización de la información de los expedientes de registro de ingrediente activo grado técnico y plaguicidas formulados.

2.- Que el Servicio Fitosanitario del Estado en adelante ( SFE ) ante una consulta de su Auditoría Interna ante la Procuraduría General de la Republica, suspendió la aplicación del Decreto 39995-MAG y actualmente por falta de procedimiento no se ha logrado actualizar la información de ninguno de los registros de los Ingredientes Activos Grado Técnico, en adelante (IAGT) y de los productos formulados que no cuentan con registro de IAGT y que no fueron inscritos conforme al Decreto Ejecutivo N° 33495-MAG-SMINAE- MEIC del 31 de octubre de 2006 y sus reformas.

3.- Que la Procuraduría General de la República ante la consulta de la Auditoría Interna del SFE emitió el dictamen No. C-199-2017 del 8 de setiembre del 2017, concluyendo respecto al Decreto Ejecutivo 39995-MAG que: "se trata de una reválida de registros previos, inscritos bajo otra normativa y no se refiere a un procedimiento de inscripción propiamente dicho. Además, según lo establecido en el numeral 6°, se pretende poner plazo de vigencia a estos registros que anteriormente eran indefinidos". "Por tanto, no se desprende de dicho Decreto que se trate de un reglamento técnico, que requiera del procedimiento de consulta al Órgano de Reglamentación Técnica. Por el contrario, se trata del desarrollo de lo dispuesto en el artículo 23 de la Ley de Protección Fitosanitaria.

4.- Que tanto la legislación nacional como la normativa internacional establecen que la información confidencial que aportan los registrantes en los procesos de registro y actualización de los expedientes, por su régimen de protección y sensibilidad comercial, debe ser custodiada por las autoridades de manera diligente y apropiada, para garantizar su inviolabilidad y uso indebido.

5.- Que las especificaciones y estándares internacionales de países y regiones de primer mundo así como de organismos internacionales de reconocido prestigio internacional son una referencia técnica y científica para determinar que los ingredientes activos grado técnico sintetizados, por los fabricantes propuestos en los procesos de actualización de expedientes, no contienen impurezas relevantes en niveles superiores de los estándares o especificaciones internacionales y las impurezas relevantes son las que son las que tienen relevancia toxicológica o ecotoxicológica, que pueden causar una afectación a la salud o el ambiente.

6.- Que los ingredientes activos grado técnico son utilizados únicamente para la formulación de plaguicidas químicos sintéticos formulados y que solo por excepción son utilizados directamente en el campo y estas situaciones de excepción ya se encuentran reguladas en la normativa técnica vigente; por ello los certificados de registro de ingredientes activos grado técnico únicamente tiene utilidad para autorizar, por parte del Servicio Fitosanitario del Estado, a la importación de estos como materia prima de formulaciones de plaguicidas en plantas de proceso y no para su uso directo en campo.

7.- Que el Decreto Ejecutivo 39995-MAG, de repetida cita estableció un plazo de veinticuatro meses para la actualización del Registro, que vence el 16 de enero del 2019 y que actualmente no se cuenta con un procedimiento que permita su aplicación, por lo que resulta oportuno y conveniente establecer un nuevo plazo razonable para la aplicación del decreto en mención y los procedimientos.

8- Que se cuenta con el visto bueno de la Dirección de Mejora Regulatoria del Ministerio de Economía, Industria y Comercio, según Informe DMR-DAR-INF-149-18, del seis de diciembre del año dos mil dieciocho”. (Lo destacado no corresponde al original).

De este modo, se reitera que la normativa bajo examen aplica solo a productos viejos, es decir, productos de los cuales ya se ha otorgado registros de IAGT o de formulado y muchos de esos registros se otorgaron a plazo indefinido. Esto significa que no requieren del decreto de actualización para seguir comercializando. Por ello, más que facilitar de lo que se trata es de imponerles una obligación para que actualicen su información y aporten datos y estudios que acrediten no solo la procedencia y origen de los materiales técnicos y de las formulaciones asociadas, sino que aporten la información química confidencial que permita a la autoridad de registro, sea al SFE, tener a disposición la información química confidencial sobre pureza, impurezas, método de síntesis, etc., de sus materiales técnicos, tanto en cuanto a los fabricantes como a los formuladores. Es justamente a partir del detalle de la información aportada que la autoridad de registro podrá tomar decisiones regulatorias respecto de la continuidad o no de un registro o de un fabricante de un material técnico de una formulación que se comercialice en Costa Rica. Como se enfatizó supra, de no someterse a este procedimiento de actualización de los registros se puede proceder según lo dispone el art. 24 de la Ley de Protección Fitosanitaria. Asimismo, con la información completa del registro se pueden tomar decisiones a la luz de lo que expresamente regula el art. 30 de la misma ley:

“Art. 30.- Prohibiciones y restricciones por razones técnicas El Ministerio de Agricultura y Ganadería podrá restringir o prohibir la importación, el tránsito, el redestino, la fabricación, la formulación, el reenvase, el reempaque, el almacenamiento, la venta, la mezcla y la utilización de sustancias químicas, biológicas o afines y equipos de aplicación para uso agrícola, cuando se justifique por razones técnicas y se considere que emplearlas es perjudicial para la agricultura, la salud o el ambiente”.

Se aprecia que este poder de policía faculta al Estado a evaluar los productos a la luz de la información actualizada y adoptar las decisiones que correspondan en aras de resguardar la agricultura, la salud o el medio ambiente.

Ahora bien, el agravio del accionante, más allá de especificar aspectos del procedimiento en concreto, se centra en cuestionar que, según su criterio, deberían intervenir el Ministerio de Salud y el MINAE. Sin embargo, como ya se examinó supra, el hecho de que no hayan participado de la adopción de la normativa, o del trámite de actualización de la información del registro, no implica en modo alguno per se una lesión al Derecho de la Constitución.

Ahora bien, aunque no fue detallado por el accionante en este apartado, conviene señalar que la presentación de información de otros expedientes de registro fue avalada por la mayoría de este Tribunal en la sentencia n.°2022-26651, a la luz de la legislación técnica internacional que lo permite, razón por la cual, respecto a estos aspectos es menester estarse a lo dicho en el referido voto.

VIII.- SOBRE EL ART. 1° DEL DECRETO El accionante afirma que la reforma parcial y adición al decreto ejecutivo n.°39995 es un beneficio a los comercializadores de plaguicidas, pues amplían el tiempo a partir de la publicación del decreto impugnado, otorgando el beneficio de cinco años más a esos productos sin que los mismos hayan pasado por una evaluación de riesgo y concediendo ese tiempo adicional para que los dueños registrales puedan presentar la información. Aun cuando en este mismo numeral se define una lista taxativa de requisitos, considera que son limitados para realizar una evaluación de riesgo. Asume que lo que persigue el despacho ministerial con la promulgación de este tipo de documentos es exigir, ordenar o intimidar a los evaluadores de registro que se circunscriban únicamente a solicitar una limitada información, que carece de sustento técnico y científico para realizar una evaluación de riesgo de acuerdo a las normas nacionales e internacionales con requisitos diezmados. Cuestiona que en el artículo de marras nuevamente el MAG insiste en el proceso de información referenciada, sin información propia o referenciada, como lo propone este reglamento. Así, el Poder Ejecutivo y la industria de plaguicidas lo que buscan es facilitar el comercio de plaguicidas en contra de la salud humana, animal y el medio ambiente.

Al respecto, el Ministro del MAG explica que el numeral impugnado mantiene su ámbito de aplicación en el sentido de que no se puede utilizar para registrar nuevos plaguicidas y lo único que cambia es lo relacionado con los plazos y uno de los requisitos administrativos. En lo relativo al tema de los plazos considera que es un tema de legalidad, pues le corresponde a la autoridad competente definir cuáles son los plazos en los que se debe realizar determinados actos y los plazos que tiene que cumplir el administrado para sus gestiones al amparo de la norma. De otra parte, se insiste en que las competencias fueron delegadas por voluntad del legislador en el MAG a través del SFE. Desde el punto de vista técnico y científico la normativa permite al Estado contar con toda la información sobre pureza, impurezas relevantes (nombre, contenido y niveles de detección), impurezas totales, método de síntesis, metodologías analíticas para determinar el IAGT y sus impurezas relevantes, de todos los IAGT registrados como tales o como componentes de una formulación, que fueron registrados en Costa Rica con legislación y normativa distinta al decreto ejecutivo n.°33495-MAG-S-MEIC-MINAET. La información química confidencial que requiere este decreto es clave y esencial, desde el punto de vista agronómico, toxicológico y ecotoxicológico, y lamentablemente no está incorporada a los expedientes de estos registros. Mucha de la información química que se solicita en el decreto, en especial, la descrita en los arts. 1 y 5, si bien es cierto se presentó durante el proceso de reválida, se encuentra totalmente desactualizada, pues han transcurrido entre cinco y diez años desde que se aportó la información y las autoridades aún no han revisado y mucho menos aprobado. Además, se permite al Estado costarricense contar con la información actualizada sobre los sitios y orígenes de formulación, nombre y ubicación física de los formuladores, así como los componentes del producto y la descripción detallada de los procesos de formulación de todos los productos formulados que se comercializan actualmente en Costa Rica.

Desde el punto de vista químico y científico se garantiza que ningún plaguicida formulado, que se comercialice en Costa Rica, pueda estar registrado y, por ende comercializado, si no cuenta con un IAGT asociado que tenga niveles de impurezas relevantes (que son las que tienen importancia toxicológica y ecotoxicológica) superiores a los niveles especificados en los estándares internacionales de referencia (FAO, EPSA, IUPAC).

La PGR considera que carece de competencias para referirse a los aspectos técnicos y de idoneidad de los requisitos exigidos para realizar la actualización de los registros. Sin embargo, sí hace ver que la Sala debe valorar técnicamente si los requisitos dispuestos por la norma impugnada para el proceso de reválida permiten realizar una adecuada valoración del riesgo ambiental o sanitario de los productos, pues, de la mera comparación de los textos del decreto n.°39995 y del decreto n.°41841 se constata que no se añadieron los requisitos técnicos que sí contemplaba el decreto n.°33495, sino que, más bien, se eliminaron y modificaron algunos puntos. Además, señala que el decreto impugnado modifica los arts. 1.2.b y 6 del decreto n.°39995 que permiten registrar productos mediante información referenciada, pero mantiene esa posibilidad en varias disposiciones y no establece de qué manera será verificable la información, cómo determinar cuál especificación internacional puede ser utilizada, la forma de determinar la equivalencia de productos, ni si el perfil de referencia a utilizar debe ser un registro que cuente con información completa. Al no establecerse con precisión las reglas a las que la autoridad competente debe ajustarse para verificar la información, es posible que se permita la actualización de registros con información referenciada que no cumple con los requisitos indicados y, por tanto, con sujeción a lo que se disponga en los criterios técnicos que se emitan, ello implicaría la actualización de registros de productos sin una evaluación previa acerca de los riesgos ambientales y sanitarios de su aplicación y la inconstitucionalidad de los artículos que permiten el uso de información referenciada sin una adecuada determinación de equivalencia.

Al respecto, la Sala considera que respecto de lo informado por la PGR conviene aclarar el argumento brindado atendiendo a las explicaciones realizadas por el Ministro del MAG. La PGR afirmó que de la mera comparación de los textos del decreto n.°39995 y del decreto n.°41841 se constata que no se añadieron los requisitos técnicos que sí contemplaba el decreto n.°33495. Sin embargo, como se ha explicado, dichos instrumentos reglamentarios regulan supuestos diferentes, lo que justificaría la exigencia de diferentes requisitos. El decreto n.°33495 regulaba todos los procedimientos de inscripción de productos nuevos, mientras que los decretos n.°39995 y n.°41841 regulan otra situación de hecho distinto, porque aplica a productos que ya están registrados y en uso en el territorio nacional, pero respecto de los cuales corresponde realizar una actualización de sus registros. Eso justificaría el trato diferenciado que cuestiona la PGR.

Ahora bien, atendiendo los agravios del accionante se debe indicar que la ampliación del plazo obedece a una situación práctica que se justificó en las consideraciones del decreto. Esto es que la aplicación del decreto anterior fue suspendida en virtud de una decisión administrativa que paralizó el procedimiento que se estaba llevando a cabo:

“Que el Servicio Fitosanitario del Estado en adelante ( SFE ) ante una consulta de su Auditoría Interna ante la Procuraduría General de la República, suspendió la aplicación del Decreto 39995-MAG y actualmente por falta de procedimiento no se ha logrado actualizar la información de ninguno de los registros de los Ingredientes Activos Grado Técnico, en adelante (IAGT) y de los productos formulados que no cuentan con registro de IAGT y que no fueron inscritos conforme al Decreto Ejecutivo N° 33495-MAG-SMINAE- MEIC del 31 de octubre de 2006 y sus reformas”. (Lo destacado no corresponde al original).

Lo anterior justifica la ampliación del plazo reclamada.

Luego, el alegato del accionante se reduce a referir que los requisitos son limitados y que implican una forma de intimidar al registrador para que no solicite mayor información de parte de los peticionarios. Dicho argumento carece de una adecuada y razonable fundamentación, pues no detalla cuáles son los requisitos que considera insuficientes. Por lo demás, en lo relativo a la aplicación, no pasa de ser una mera apreciación subjetiva de una eventual consecuencia de la norma, que no tiene sustento en un elemento objetivo que se desprenda de la cláusula bajo análisis. Tampoco lo tiene la presunción del accionante de que estas normas procuran facilitar la labor de los comerciantes, todo lo cual fue rechazado y justificado en el informe del MAG. Por lo tanto, esta Sala estima que estos agravios deben ser desestimados.

En lo relativo a la información referenciada, este Tribunal en la sentencia n.°2022-26651, como se ha dicho, realizó un análisis de la legislación técnica internacional que permite presentar información de otros expedientes de registro y concluyó que la posibilidad de utilizar la información referenciada de registros de autoridades no nacionales, para tramitar los procedimientos de registro, no resulta inconstitucional, porque está justificado en los instrumentos técnicos y científicos internacionales que esta sentencia se ocupa de señalar. Razón por la cual, respecto a estos aspectos es menester estarse a lo dicho en el referido voto y desestimar los agravios.

IX.- SOBRE EL ART. 2 El accionante acusa que la reforma planteada disminuye el tiempo para que los evaluadores tomen una decisión y se pasa de tres meses definida en el decreto ejecutivo n.°39995 a un mes en la modificación planteada en el decreto n.°41481-MAG. Aduce que así evidencia en este tipo de normativa lo que se busca es el beneficio a las empresas vendedoras de agroquímicos, para que los analistas de registro realicen el análisis presionados por el tiempo, sin que se tenga un estudio de cargas de trabajo para determinar el tiempo propuesto. Añade que lo más grave es que el análisis planteado en este decreto está definido como una simple constatación de documentos químicos, es decir, si los registrantes presentaron o no la información, pero es tal el grado de descoordinación, que esta verificación de documentos que son de índole química, se la asignan a los profesionales en agronomía, que no tienen las competencias ni la formación para realizar esta tarea. Esta propuesta planteada es una nueva modalidad de registro que solo se realiza con un simple “check list” o lista de verificación.

El Ministro del MAG sostiene que en este extremo la parte accionante se limita a objetar temas de mera legalidad y es omiso en cuanto a las alegadas inconstitucionalidades de la norma que objeta. Señala que, incluso, de la lectura pura y simple del texto, queda de manifiesto que es falaz la afirmación del accionante en el sentido de que se estén otorgando registros a nuevos productos mediante esta normativa reglamentaria. Agrega que tampoco es cierto como lo afirma el accionante que son agrónomos los que están a cargo de la revisión de la información química; pero más allá de las inexactitudes y falacias en las que incurre el accionante, queda claro que sus alegatos son sobre aspectos administrativos y de mera legalidad que no corresponde dirimir a la Sala Constitucional sino a la jurisdicción ordinaria.

La PGR considera que debe declararse la inconstitucionalidad del art. 2° si, con base en los criterios técnicos que se hagan llegar al expediente, se determina que la reducción del plazo de tres meses a un mes, para que el SFE verifique y analice la información presentada y resuelva la solicitud de actualización del producto y otorgue el certificado de registro, impide que se efectúe una adecuada valoración del riesgo ambiental y sanitario del producto. Añade que, sin perjuicio de lo que se resuelva sobre ese artículo, es conveniente que la Sala Constitucional aclare si resulta aplicable la regla de que la figura del silencio positivo no opera en el caso de las aprobaciones o autorizaciones ambientales y que, por tanto, el incumplimiento del plazo dispuesto por parte de la Administración no implicaría la aprobación automática de la reválida del producto.

La norma actual en comparación con el decreto original establece lo siguiente:

Reglamento para la actualización de la información de los expedientes de registro de ingrediente activo grado técnico y plaguicidas formulados, n.°39995-MAG Reforma Reglamento para la actualización de la información de los expedientes de registro de ingrediente activo grado técnico y plaguicidas formulados, n.°41481 – MAG ART. 2 A los plaguicidas formulados cuyo IAGT no se encuentre registrado, y cuyo expediente ha sido actualizado conforme al artículo anterior, el Servicio Fitosanitario del Estado le otorgará, en un plazo no mayor de tres meses, contados a partir de la fecha en que se le aprobó la actualización, el correspondiente registro de IAGT.

ART. 2 Una vez recibida la solicitud de actualización del fabricante o cuando el solicitante haya aportado la información que se le previno, el SFE procederá en un plazo de treinta días a verificar que el ingrediente activo grado técnico sintetizado o fabricado por el fabricante propuesto en la solicitud de actualización no contiene impurezas relevantes en niveles superiores de los estándares o especificaciones internacionales, así como la verificación de que el ingrediente activo grado técnico no se encuentra incluido en el Anexo III del Convenio de Rotterdam, o en el Convenio de Estocolmo, o en el Protocolo de Montreal.

La evaluación de la información química por parte del SFE tendrá por objeto verificar que está completa la información química confidencial y no confidencial, que aquí se establece, que los ensayos y análisis fueron realizados con el material técnico sintetizado o fabricado por el fabricante o formulador, según sea el caso, propuesto en la solicitud de actualización y la información química confidencial corresponde al IAGT sintetizado por el fabricante propuesto; cumplida la verificación anterior el Servicio Fitosanitario del Estado, procederá a dictar en el plazo indicado en este artículo, la resolución aprobando la solicitud de actualización.

(Así reformado por el art. 2 del decreto ejecutivo N° 41481 del 10 de diciembre del 2018) Para la Sala los argumentos de inconstitucionalidad carecen de una adecuada fundamentación. El mero hecho de que se reduzcan los plazos de resolución no quiere decir que este procedimiento en sí mismo resulte menos garantista o lesivo de disposiciones constitucionales. Se ha de sobreentender que en virtud de los principios constitucionales que deben regir el funcionamiento de toda la Administración Pública, las autoridades del SFE ‒como legalmente designadas para la resolución de este tipo de gestiones‒ deben resolver con eficiencia y prontitud la solicitud de actualización del registro; pero, del mismo modo, tienen la obligación máxima de velar por la protección fitosanitaria como una materia de interés público.

También vale la pena destacar que muchos de los agravios planteados por el accionante parten de una premisa genérica de que los requisitos no son suficientes y que se están facilitando los medios para que, en su aplicación (reducción de plazos y autoridad competente) se vean favorecidos los comerciantes de estos productos. Al respecto, este tribunal observa que no hay una fundamentación apropiada en el tema de los requisitos (cuáles sí y cuáles no) y el accionante no se refiere a la eventual forma en que la Administración (SFE) va a ejercer sus competencias. Esto, por lo demás, no sería objeto de una acción de inconstitucionalidad, sino de un control que debe ser llevado por toda la Administración Pública y la jurisdicción ordinaria, a efecto de que las competencias legalmente asignadas sean ejercidas con rigor y eficiencia.

Tampoco hay ninguna evidencia en la norma cuestionada de que esta evaluación sea realizada por profesionales en agronomía y que estos carezcan de las competencias o la pericia necesaria para hacer una valoración apropiada de la documentación presentada, siempre en resguardo del medio ambiente y la salud de las personas.

En lo atinente a lo afirmado por la PGR, considera esta Sala que igualmente sus presunciones parten de una premisa equivocada, porque se refiere a “otorgar el certificado de registro”; sin embargo, como se ha explicado, la normativa de marras no regula propiamente el registro de los productos, pues los mismos ya están en el mercado, sino que lo que se exige es la actualización de toda la información de sus registros. Ahora bien, en lo concerniente a la solicitud de aclaración que realiza la PGR, estima este Tribunal que es claro que para todo lo concerniente a inscripción ‒que no es el caso de la normativa bajo análisis‒ o a la actualización de la información en los registros, no resulta de aplicación el instituto del silencio positivo. En nuestra legislación se ha permitido la aplicación del silencio positivo ‒ a partir del momento en que se haya presentado la solicitud con sus requisitos formales, ante el órgano competente y en la forma requerida por la ley‒ únicamente para aquellas gestiones del administrado que sean relacionadas a licencias, permisos, autorizaciones, o cuando una norma en específico así lo autorice explícitamente. El propósito de esta figura jurídica es brindarle al administrado una forma reglada y célere de resolver sus solicitudes cuando, por un motivo u otro, la Administración ha demorado en brindarle certeza jurídica sobre lo requerido. No obstante, desde larga data este Tribunal ha sido contundente en señalar que en temática ambiental –no sólo por la protección en sí del medio ambiente, sino también por la repercusión que tiene en la salud de las personas‒ no opera el silencio positivo. Por ejemplo, desde la sentencia n.°1994-6332 se ha estimado lo siguiente:

“El punto en discusión en este recurso de amparo es la aplicabilidad o no de la figura jurídica del silencio positivo con respecto a la licencia o autorización solicitada -por el recurrente- para la recolecta científica de lapas rojas. Al respecto, este órgano constitucional ha sostenido que en términos generales, el silencio positivo opera ante la inercia de la Administración y en aquéllos casos en que el petente ha cumplido con todos los requisitos para su otorgamiento, lo cierto es que la protección y preservación de la integridad del medio ambiente natural es un derecho fundamental, de modo que no puede entenderse que el silencio positivo procede simplemente por el transcurso del plazo dentro del cual la Administración debió pronunciarse sobre el permiso para la obtención de individuos silvestres de "Ara Macao" con fines científicos para la conservación en la región del Pacífico Central. De ahí que la Fundación Pro Iguana Verde no puede derivar derechos subjetivos en aplicación del mencionado instituto jurídico, pues el interés público representado por el Estado en cuanto a su obligación de velar por el derecho que le asiste a toda persona de gozar de un ambiente sano y ecológicamente equilibrado, predomina sobre el interés privado de la explotación de la vida silvestre”. (Criterio reiterado en sentencias números 1999-01149, 2000-01375 y 2006-14479).

Tales consideraciones fueron replicadas por esta Sala en la sentencia n.°2016-017375 que concluyó lo siguiente: “se ha afirmado además con claridad que en esta materia ambiental tampoco opera la figura del silencio positivo”.

En materia de inscripción de medicamentos ‒lo que claramente tiene una incidencia en la salud de las personas‒, la Sala también ha advertido la inaplicabilidad del silencio positivo. En la sentencia n.°2006-000688 se plasmaron las siguientes reflexiones:

“La importancia que encierra este preciado derecho, así como el deber de la Administración otorgado a nivel constitucional, de velar por su resguardo, permite concluir que sería contrario al Estado Social de Derecho propugnado por nuestra Carta Magna, el permitir la aplicación del concepto del silencio positivo en materia de inscripción de medicamentos. Considera este Tribunal Constitucional que el ya mencionado procedimiento de inscripción de medicamentos llevado a cabo por el Ministerio de Salud, requiere de un meticuloso análisis técnico que permita concluir certeramente si el producto en cuestión no representa un peligro para la salud de los habitantes del país; razón por la cual, es indispensable que dicho trámite sea realizado eficientemente. Frente a lo argumentado anteriormente, estima esta Sala que es necesario aclarar que la figura del silencio positivo, especialmente en casos como el presente, de ninguna manera podría concebirse como el simple transcurso del plazo durante el cual la Administración debió pronunciarse sobre un asunto; ello por encontrarse la protección del derecho a la salud de por medio (en este sentido ver la resolución No. 1999-1149 de las 19:33 horas del 17 de febrero de 1999)”.

Las pautas jurisprudenciales de esta Sala en materia ambiental fueron recogidas en la Ley Forestal n.°7575 de 16 de abril de 1996, que indica lo siguiente:

“Art. 4.- Silencio positivo En materia de recursos naturales no operará el silencio positivo, contemplado en los artículos 330 y 331 de la Ley General de la Administración Pública.

Cuando la Administración Forestal del Estado no resuelva los asuntos sometidos a su conocimiento, dentro de los plazos estipulados en la Ley General de la Administración Pública, el funcionario responsable se expondrá a las sanciones dispuestas en las leyes”. (Así reformado por el artículo 1° de la ley n.°10072 del 18 de noviembre de 2021. Lo destacado no corresponde al original).

Asimismo, se recogieron en la reciente reforma realizada a la Ley de Protección al ciudadano del exceso de requisitos y trámites administrativos n.°8220, que en lo conducente advierte lo siguiente:

“Quedan exceptuados de la aplicación del silencio positivo, las licencias, los permisos y las autorizaciones en materia de salud pública y ambiente y aquellas materias en las que por disposición constitucional, legal o jurisprudencia judicial, expresamente así lo indiquen. Cada institución debe señalar expresamente, en el Catálogo Nacional de Trámites, para qué casos específicos no resulta aplicable esta figura, so pena de incurrir en una falta administrativa por parte del oficial de Simplificación de Trámites”. (Lo destacado no corresponde al original).

Por lo tanto, atendiendo a la jurisprudencia reiterada de esta Sala y a la normativa legal vigente, se tiene que tratándose de trámites relacionados con la inscripción o actualización de plaguicidas, por su clara incidencia en el medio ambiente y la salud de las personas, no aplica la figura administrativa del silencio positivo.

Finalmente, cabe enfatizar que si las partes comerciantes no se ajustan a este procedimiento de actualización de requisitos en los plazos dispuestos, la Administración queda habilitada para aplicar las disposiciones legales en la materia y se puede cancelar el registro (art. 24) y la persona se expone a las multas correspondientes (art. 76, ambos de la Ley de Protección Fitosanitaria).

X.- SOBRE EL ART. 3 El accionante afirma que, nuevamente, el despacho ministerial acorta el tiempo establecido en el decreto ejecutivo n.°39995 en beneficio de los usuarios, sin que se conozca si se tiene un estudio técnico de cargas de trabajo que sustente tal decisión de pasar de tres meses a diez días para realizar la evaluación técnica por parte de funcionarios del SFE, pues en este decreto exceptúan en forma unilateral la participación en temas de salud y ambiente a los ministerios correspondientes.

Cuestiona concretamente el párrafo que señala que “a los plaguicidas formulados que no cuentan con un registro de ingrediente activo grado técnico asociado a esa formulación y que el fabricante de ese formulado haya sido actualizado conforme este reglamento, el SFE le otorgará, el certificado de registro de ingrediente activo grado técnico”. Considera que ese decreto se opone a cualquier principio técnico científico activo que rige la materia de registro, pues es otorgar un registro sin mediar siquiera en proceso básico que rige la normativa de registro cual es la evidencia química.

En cuanto a este numeral, el Ministro del MAG reitera su explicación técnica sobre el propósito de esta normativa:

“Como ya habíamos señalado en Costa Rica antes del 10 de enero del 2007 el sistema de registro establecía que se podía registrar una formulación sin necesidad de contar con un registro de la materia prima, es decir de su ingrediente activo grado técnico (IAGT), luego de esa fecha, se estableció que toda formulación de previo a ser registrada requería del registro de su IAGT, esto hace que en la actualidad un número enorme de alrededor de mil quinientos productos formulados no estén asociados a un fabricante, por eso es que en el Decreto Ejecutivo N° 39995-MAG del 15 de diciembre 2016 y su reforma (Decreto Ejecutivo N° 41481-MAG del 10 de diciembre 2018, publicado el 11 de enero del 2019, alcance número 8 del Diario Oficial La Gaceta), se establece un proceso de actualización que permitirá al sistema de registros garantizar que toda formulación que se comercialice en el país, estará asociada a un fabricante del IAGT, de tal manera que esa actualización del fabricante no implica que se esté otorgando el registro a un producto nuevo sino que mediante este proceso de actualización la autoridad contará con la información necesaria para determinar si el material técnico con el que se formula ese producto formulado no contiene impurezas relevantes y que además cumple con la especificación internacional que debe cumplir todo IAGT para la formulación de plaguicidas, de modo que es incorrecto lo que indica la accionante en cuanto a la falta de fundamento técnico o científico y a la confusión que hace con el registro bajo la modalidad de equivalencia por cuanto el proceso lo que plantea no es una equivalencia sino una actualización de la información de un registro vigente de un producto formulado que no cuenta con un fabricante de IAGT asociado a su registro, recordando que en virtud del artículo 3 no es que se esté autorizando un producto nuevo sino que es asociando un fabricante a esa formulación que ya cuenta con registro y que se comercializa en el país”.

Además, se refiere a que los cuestionamientos sobre aspectos de plazos y cargas de trabajo son discusiones de mera legalidad y no de constitucionalidad.

La norma en cuestión, comparativamente con la anterior, dispone lo siguiente:

Reglamento para la actualización de la información de los expedientes de registro de ingrediente activo grado técnico y plaguicidas formulados, n.°39995-MAG Reforma Reglamento para la actualización de la información de los expedientes de registro de ingrediente activo grado técnico y plaguicidas formulados, n.°41481 – MAG ART. 3 El Servicio Fitosanitario del Estado resolverá en un plazo de tres meses las solicitudes previstas en el artículo 1. 1 y un plazo de seis meses las solicitudes que se presenten para la situación jurídica establecida en el artículo 1.2.

ART. 3 Estando firme la resolución que aprueba la solicitud de actualización, en un plazo de diez días, contados a partir de la firmeza de la misma, el SFE otorgará el certificado de registro de ingrediente activo grado técnico por un plazo de diez años, contados a partir de su fecha de emisión. A los plaguicidas formulados que no cuentan con un registro de ingrediente activo grado técnico asociado a esa formulación y que el fabricante de ese formulado haya sido actualizado conforme este reglamento, el SFE le otorgará, el certificado de registro de ingrediente activo grado técnico por un plazo de diez años, contados a partir de su fecha de emisión. La emisión de estos certificados no tendrá costo alguno para el administrado por tratarse de ingredientes activo grado técnico o formulaciones con registro vigente que se están comercializando actualmente.

(Así reformado por el artículo 3° del decreto ejecutivo N° 41481 del 10 de diciembre del 2018) En relación con los agravios planteados, observa la Sala que los argumentos sobre la definición de plazos y las cargas de trabajo del SFE y la excepción de la participación de los ministerios de Salud y Ambiente y Energía ya han sido atendidos en los apartados anteriores. La mera circunstancia de que se reduzcan los plazos de resolución no implica por sí misma una lesión al Derecho de la Constitución y el hecho de que se concentren las competencias de actualización de los registros en el SFE es una consecuencia de una disposición legal (art. 23 de la Ley del Servicio Fitosanitario del Estado), que no tiene de suyo viso de inconstitucionalidad ni ha sido impugnado.

En lo relativo al registro, se deben retomar las explicaciones del ministro en el sentido de que este procedimiento no implica como tal otorgar un registro nuevo, sino actualizar toda la información faltante del producto y que esto permita a las autoridades determinar si contiene impurezas relevantes que ameriten algún tipo de replanteamiento del registro. Como se ha venido insistiendo, el procedimiento que regula la normativa bajo examen es para productos que ya están registrados y en el mercado (ya existe una habilitación administrativa), de manera que se solicita información a efecto de su revaloración. Además, como se ha visto en los informes transcritos en esta sentencia, anteriormente la vigencia de los registros estaba prevista de forma indefinida, mientras que con la normativa bajo análisis se introducen topes y límites a ese registro.

XI.- SOBRE EL ART. 4 (que reforma el art. 5 del decreto n.°39995) El accionante insiste que el proceso de facilitación registral que establece el decreto ejecutivo n.°414131 va en contra del deber ser del Estado de proteger a toda la sociedad costarricense. Estima que solamente se enumeran requisitos para salir del paso, y que no van a sustentar ninguna información para realizar una evaluación técnica científica de análisis de riesgo.

El Ministro del MAG explica que al hacer el análisis del art. 5 la parte accionante confunde el concepto de fabricante con el de formulador, de tal manera que toda la hipótesis, las objeciones y los análisis que hace de dicha norma, no son aplicables a la situación jurídica que regula la actualización de formuladores del decreto ejecutivo n.°39995-MAG del 15 de diciembre 2016 y su reforma n.°41481-MAG.

La norma en cuestión, comparativamente con la anterior, dispone lo siguiente:

Reglamento para la actualización de la información de los expedientes de registro de ingrediente activo grado técnico y plaguicidas formulados, n.°39995-MAG Reforma Reglamento para la actualización de la información de los expedientes de registro de ingrediente activo grado técnico y plaguicidas formulados, n.°41481 – MAG ART. 5 Los titulares de los registros vigentes de plaguicidas formulados, que no hayan sido inscritos conforme al Decreto Ejecutivo N° 33495-MAG-S-MINAE-MEIC del 31 de octubre de 2006 y sus reformas, deberán actualizar la información, pudiendo mantener el formulador registrado, cambiar o adicionar formuladores del producto, cambiar o ampliar el sitio y origen de formulación, en un plazo de veinticuatro meses a partir de la entrada en vigencia de este decreto, aportando al Servicio Fitosanitario del Estado la siguiente información:

1-Solicitud para mantener, cambiar o adicionar formuladores del producto, cambiar o ampliar el sitio y origen de formulación, donde se indique el número de registro y la fecha en que fue otorgado.

2-Certificado de registro expedido por la autoridad del país de origen, cuando este se encuentre registrado en ese país.

3-Certificado de Composición cuali-cuantitativa, así como el certificado de análisis del producto formulado, los cuales deberán contar con el refrendo químico, conforme a lo dispuesto en la Ley N° 8412 del 22 de abril de 2004 y sus reformas. El certificado de composición cuali-cuantitativo del producto formulado debe ser emitido por el nuevo formulador, cuando el mismo haya cambiado.

4-Declaración jurada del titular del registro, que haga constar que se mantiene el proceso, la composición de formulación y que se utiliza un IAGT autorizado por la AC, ya sea porque se encuentra dicho IAGT previamente registrado como tal, o es sujeto a lo dispuesto en el presente decreto.

5-En un plazo de 8 días hábiles, contados a partir de la notificación de la resolución que aprueba la actualización solicitada, se deberá presentar el proyecto de etiqueta y panfleto del producto formulado, conteniendo la información que se indica en el Reglamento Técnico Centroamericano No. RTCA 65.05.67. 13: Insumos Agrícolas. Ingrediente Activo Grado Técnico, Plaguicidas Químicos Formulados, Sustancias Afines, Coadyuvantes y Vehículos Físicos de Uso Agrícola. Requisitos para la elaboración de etiquetas y panfletos. Resolución No. 365-2015 (COMIECO LXXII). El Servicio Fitosanitario del Estado, en un plazo de cinco días hábiles, revisará y notificará, la aprobación del proyecto de identificación.

6-Comprobante de pago del arancel vigente. En caso que hubiese cancelado este arancel para el trámite de cambio de formulador, al amparo del decreto ejecutivo N° 35312-MAG-S-MINAETMEIC: RTCR 428: 2009 y la solicitud no hubiese sido resucita durante el período en que estuvo vigente dicho decreto, no deberá hacer dicho pago nuevamente.

ART. 5 Los titulares de los registros vigentes de plaguicidas formulados, que no hayan sido inscritos conforme al Decreto Ejecutivo N° 33495-MAG-S-MINAE-MEIC del 31 de octubre de 2006 y sus reformas, deberán actualizar la información, pudiendo mantener el formulador registrado, cambiar o adicionar formuladores del producto, cambiar o ampliar el sitio y origen de formulación, en un plazo de sesenta meses a partir de la entrada en vigencia de este decreto, aportando al Servicio Fitosanitario del Estado la siguiente información:

1-Solicitud para mantener, cambiar o adicionar formuladores del producto, cambiar o ampliar el sitio y origen de formulación, donde se indique el número de registro y la fecha en que fue otorgado.

2-Certificado de Composición cuali-cuantitativa, así como el certificado de análisis del producto formulado. El certificado de composición cuali-cuantitativo del producto formulado debe ser emitido por el nuevo formulador, cuando el mismo haya cambiado.

3-Declaración jurada del titular del registro, que haga constar que se mantiene el proceso, la composición de formulación y que se utiliza un IAGT autorizado por la AC, ya sea porque se encuentra dicho IAGT previamente registrado como tal, o es sujeto a lo dispuesto en el presente decreto.

4-En un plazo de 8 días hábiles, contados a partir de la notificación de la resolución que aprueba la actualización solicitada, se deberá presentar el proyecto de etiqueta y panfleto del producto formulado, conteniendo la información que se indica en el Reglamento Técnico Centroamericano No. RTCA 65.05.67. 13: Insumos Agrícolas. Ingrediente Activo Grado Técnico, Plaguicidas Químicos Formulados, Sustancias Afines, Coadyuvantes y Vehículos Físicos de Uso Agrícola. Requisitos para la elaboración de etiquetas y panfletos. Resolución No. 365-2015 (COMIECO LXXII). El Servicio Fitosanitario del Estado, en un plazo de cinco días hábiles, revisará y notificará, la aprobación del proyecto de identificación.

5-Comprobante de pago del arancel vigente. Por tratarse de una actualización de un registro vigente, las solicitudes de actualización de formuladores que se presenten al amparo de este artículo no deberán cancelar el arancel establecido para las modificaciones al registro.

(Así reformado por el art. 4 del decreto ejecutivo N° 41481 del 10 de diciembre del 2018) En criterio de la Sala, el accionante no fundamenta apropiadamente los motivos por los cuales considera que los requisitos ahí exigidos “no van a sustentar ninguna información para realizar una evaluación técnica científica de análisis de riesgo”. Se trata de un argumento genérico, por lo que este Tribunal no puede hacer un examen riguroso de constitucionalidad al respecto.

Además, se hace preciso reiterar el criterio de esta Sala en la sentencia n.°2009-008917, que estableció lo siguiente:

“En primer término, los accionantes solicitan que se declare la inconstitucionalidad de los artículos 1, 7 y 8 de la Ley número 8702, denominada Trámite de Solicitudes de Registro de Agroquímicos, aduciendo que la ley no exige una serie de requisitos técnicos esenciales que, a su juicio, deben ser requeridos a efecto de registrar un agroquímico, por lo que esas omisiones contravienen los derechos fundamentales a la salud y a un ambiente sano y ecológicamente equilibrado. Al respecto, cabe mencionar que si bien este Tribunal Constitucional se encuentra facultado para actuar como un legislador negativo, con la potestad de anular del ordenamiento jurídico todas aquellas normas que considere inconstitucionales, lo cierto es que se encuentra impedido para actuar como un legislador positivo creador de normas. Por otra parte, aún cuando esta Sala es competente para conocer de las omisiones legislativas conforme lo establece el artículo 73 de la Ley de la Jurisdicción Constitucional, es importante aclarar que no toda omisión normativa puede ser objeto de impugnación por esta vía. En ese sentido, solo aquellas omisiones que se producen como consecuencia de un mandato expreso y directo contenido en el derecho de la Constitución pueden ser objeto de control de constitucionalidad por la vía de la acción. Ahora bien, en el caso concreto, las omisiones impugnadas por los accionantes no provienen de un mandato expreso del constituyente, se trata más bien de omisiones que éstos dicen encontrar en el texto de la ley, sin que el deber de legislar en el sentido explicado por los actores provenga de la Constitución Política. Asimismo, al ser éste un Tribunal que actúa como legislador negativo, que queda claro que una eventual sentencia estimatoria, con la consecuente eliminación de la norma, no repararía las omisiones indicadas por los accionantes, por lo que la acción planteada en esos términos, carece de utilidad y por ende es manifiestamente improcedente. Por otro lado, se observa que, en el fondo, lo que los accionantes pretenden es que esta Sala determine si los requisitos que las normas exigen para el registro de un agroquímico son técnica y científicamente procedentes o no y, en caso de no serlo, pronunciarse sobre la lista de requisitos que a su juicio debería contener la normativa. Sin embargo, es preciso indicar que este Tribunal no es el órgano competente para ejercer esa función, pues ello es una competencia asignada al legislador, quien en uso de sus potestades discrecionales se encarga de diseñar los procedimientos y requisitos legales que deben cumplirse para el registro de agroquímicos en el país. Únicamente, en aquellos casos en los que el legislador excede esa potestad discrecional en perjuicio directo de los derechos fundamentales de las personas es que esta Sala puede válidamente conocer y pronunciarse al respecto. Sin embargo, como en este caso lo impugnado no es en sí el texto de las normas o la discrecionalidad del legislador, sino aquello que a criterio de los actores omite la ley, este Tribunal no puede pronunciarse con el fin suplantar competencias y establecer esos requisitos. Bajo tales circunstancias, la acción resulta inadmisible”. (Lo destacado no corresponde al original).

Corresponde replicar esta ratio en el caso concreto en el tanto, como se advirtió, no hay ninguna precisión en la fundamentación del accionante y la Sala no se puede atribuir la potestad de hacer determinaciones técnicas y científicas sobre si los requisitos exigidos en el numeral de marras son o no suficientes para cumplir el mandato del legislador y los mandatos constitucionales derivados de los arts. 21, 46 y 50 constitucionales.

XII.- Sobre el art. 5 (que reforma el art. 6 del decreto n.°39995) El accionante afirma que el proceso de equivalencia química propuesto en este artículo se contrapone a las normas internacionales, a la sentencia de Sala Constitucional n.°2011-016937 y a los informes de la CGR. Argumenta que no se ha propuesto por parte de estas instituciones un procedimiento para la evaluación de la equivalencia en los productos formulados. Además, cuestiona que la base de datos no constituye ninguna solución.

El Ministro del MAG respondió estos agravios explicando que el art. 6 del decreto impugnado garantiza, en su redacción actual, primero que Costa Rica dejará de contar con registros a plazo indefinido, porque a partir de la actualización, todos los registros de IAGT y producto formulados tendrán una vigencia de diez años imponiendo la obligación de renovarlos y no como ahora donde al ser a plazo indefinido no deben ser renovados por no contar con fecha de expiración; segundo, que todas las formulaciones que se venden en el mercado actualmente contarán con un fabricante asociado y no como ahora donde no se tiene conocimiento de los sitios y orígenes de fabricación de las materias primas; tercero, que todo IAGT que se utilice en Costa Rica para la formulación de productos autorizados para comercializarse en Costa Rica tiene acreditado su pureza y que no tiene impurezas relevantes por encima de la especificación internacional; cuarto, que todos los IAGT que se utilizan en Costa Rica cumplen con los convenios internacionales suscritos por Costa Rica (Anexo III del Convenio de Rotterdam, en el Convenio de Estocolmo, o en el Protocolo de Montreal); y quinto, que el SFE creará una base de datos de información toxicológica, ecotoxicológica y de destino ambiental de los ingredientes activos grado técnico que se encuentran registrados y que no cuentan con plazos vigentes de protección de datos de prueba. Afirma que es muy importante que el SFE cuente con un banco de información para las moléculas que no son nuevas y cuyos datos de prueba están libres de uso por no contar con plazos vigentes de protección. Además es necesario que las empresas que tengan información toxicológica, ecotoxicológica y de destino ambiental de los ingredientes activos grado técnico que no son nuevos aporten información que han logrado recopilar y que sirva para que en futuro el SFE pueda ir conformando un perfil toxicológico, ecotoxicológica y de destino y comportamiento ambiental, completo, que permita tener un perfil de referencia para los registros por equivalencia.

Al respecto, la PGR sostuvo que al no establecerse con precisión las reglas a las que la autoridad competente debe ajustarse para verificar la información, es posible que se permita la actualización de registros con información referenciada que no cumple con los requisitos indicados y, por tanto, ello implicaría la actualización de registros de productos sin una evaluación previa acerca de los riesgos ambientales y sanitarios de su aplicación. De constatarse lo anterior, según los criterios técnicos que se emitan al efecto, ello implicaría la inconstitucionalidad de los artículos que permiten el uso de información referenciada sin una adecuada determinación de equivalencia.

La norma en cuestión, comparativamente con la anterior dispone lo siguiente:

Reglamento para la actualización de la información de los expedientes de registro de ingrediente activo grado técnico y plaguicidas formulados, n.°39995-MAG Reforma Reglamento para la actualización de la información de los expedientes de registro de ingrediente activo grado técnico y plaguicidas formulados, n.°41481 – MAG ART. 6 Los registros que no hayan sido otorgados de conformidad con el Decreto Ejecutivo 33495-MAG-S-MINAE-MEIC del 31 de octubre de 2006 y sus reformas que hayan cumplido con lo dispuesto en este Decreto, tendrán una vigencia de diez años a partir de que la Autoridad Competente apruebe la actualización. Durante este plazo deberán entrar en un proceso de registro de conformidad con lo que indique la normativa vigente.

En caso (le que no se cuente con el perfil de referencia para su registro por equivalencia, el titular del registro podrá aportar información referenciada a partir de literatura científica o bases de datos aprobadas por la AC, a fin de completar la información química, toxicológica, ecotoxicológica y de destino ambiental, corno base para el registro.

ART. 6 Los registros de ingrediente activo grado técnico o de producto formulado que hayan sido actualizados conforme a lo dispuesto en este reglamento, tendrán una vigencia de diez años, a partir de que la Autoridad Competente emita el nuevo certificado de registro. Durante este plazo, el SFE verificará que los registros de ingrediente activo grado técnico actualizados tienen equivalencia química con el perfil de referencia de ese ingrediente activo grado técnico y en ausencia de este, verificarán que no contienen impurezas relevantes en niveles superiores de los estándares o especificaciones internacionales, así como que el ingrediente activo grado técnico no se encuentra incluido en el Anexo III del Convenio de Rotterdam, en el Convenio de Estocolmo, o en el Protocolo de Montreal.

El SFE creará una base de datos de información toxicológica, ecotoxicológica y de destino ambiental de los ingredientes activos grado técnico que se encuentran registrados y que no cuentan con plazos vigentes de protección de datos de prueba.

(Así reformado por el artículo 5° del decreto ejecutivo N° 41481 del 10 de diciembre del 2018) En relación con los planteamientos del accionante, considera esta Sala que son omisos y confusos y que no procede suplir la argumentación que le correspondería realizar a aquel. Este Tribunal ya ha advertido lo siguiente:

“No podría, por ejemplo, la Sala incurrir en activismo judicial o sustituir al accionante en su deber de argumentar. Por este motivo, también, la sentencia debe ser “… congruente con lo pretendido …” en el escrito de interposición”. (Sentencia n.°2022-026592).

En el sub lite el accionante indica que no hay un procedimiento para la evaluación de la equivalencia; sin embargo, omite señalar en cuáles instrumentos se exige que, además, las autoridades deban detallar un procedimiento para la evaluación de la equivalencia, por lo que le impide a esta Sala realizar un análisis riguroso de la cuestión. En todo caso, este mecanismo, el de utilizar perfiles de referencia, fue examinado en otra acción que fue desestimada en la sentencia n.°2022-26651. También fue ampliamente valorado en la sentencia n.°2022-023238, en la cual se explicó que no se trata de un procedimiento automático, sino que requiere de un adecuado análisis y fundamentación, que debe ser controlado en cada caso concreto. En consecuencia, esta Sala se remite a las consideraciones realizadas en aquellas resoluciones.

Por lo demás, se aprecia que en la norma bajo análisis se exige también que, en ausencia del informe de equivalencia, se verifique que el IAGT no contenga impurezas relevantes en niveles superiores a los estándares o especificaciones internacionales, así como que el ingrediente activo grado técnico no se encuentra incluido en el Anexo III del Convenio de Rotterdam, en el Convenio de Estocolmo, o en el Protocolo de Montreal. De manera que se establecen expresamente estándares para realizar el análisis en cuestión. Las autoridades del SFE, como se ha advertido, deben ser diligentes y exigentes en la materia dado que está de por medio la salud de las personas y el medio ambiente sano y ecológicamente equilibrado. Por eso, en el trámite de registro y actualización de la información, dichas autoridades están obligadas a aplicar los más altos estándares de protección a dichos derechos fundamentales y ser respetuosas del principio precautorio. Igualmente, están en la obligación de actualizarse e ir ajustándose a las novedades técnicas o los estándares internacionales en protección fitosanitaria. En efecto, como ya se advirtió supra y corresponde insistir, esta Sala llama la atención para advertir que –ante el menor vestigio de duda– deben requerir toda la documentación o estudios que sean pertinentes, con el propósito de verificar que el producto sobre el que se va a actualizar el registro cumple con los parámetros y condiciones necesarias para resguardar la salud humana y la seguridad alimentaria. Asimismo, les es exigible velar porque su uso sea el apropiado y tenga los efectos deseados. Tan importante es el rigor en la selección de los estudios, como los controles posteriores que puedan ser llevados a cabo en la aplicación y uso de los productos.

En consecuencia, de lo apuntado por el accionante, no se acredita una lesión al Derecho de la Constitución.

Xiii.- Sobre el art. 6 (que reforma el art. 7 del decreto n.°39995) El accionante acusa que este artículo contiene una propuesta de registro acientífica, que se aparta de normas nacionales e internacionales, y podría ser inconstitucional por lesiva del principio precautorio. Aduce que el Poder Ejecutivo promulgó este decreto que, en congruencia al objetivo del mismo, lo debió titular “normativa para la facilitación registral”, donde la prioridad es la actualización o reválida de registro con información referenciada, presionando a los analistas de registro al acortar los tiempos de respuesta, proponiendo el proceso de registro con solo una simple verificación de la información y separando a los Ministerios de Salud y Ambiente en su análisis de registro.

El Ministro del MAG refiere que el texto actual no guarda ninguna relación ni congruencia con los comentarios y afirmaciones temerarias que hace el accionante sobre este artículo específico. Respecto de la aseveración de que esta norma invierte el principio de la carga de la prueba o el principio precautorio, la rechaza “de manera absoluta y categórica”, no solo porque se trata de un tema de legalidad a discutir en la jurisdicción ordinaria, sino que el texto actual del art. 7 tiene sustento en reiterados dictámenes de la PGR y en sentencias de la Sala Constitucional. Reitera que es incorrecto y temerario indicar, como lo hace el accionante, que el decreto cuestionado transgreda el principio precautorio en materia ambiental, como también es incorrecto afirmar, como lo hace el accionante en este hecho y en sus alegatos, que se invierte la carga de la prueba.

Señala que la norma objeto de acción no permite o posibilita otorgar registros para nuevos productos a los que ya se comercializan en el mercado, esto por cuanto su ámbito de aplicación es muy claro y solo es factible aplicarlo a registros vigentes que hayan sido otorgados al amparo de regulaciones (legales o reglamentarias) diferentes al decreto ejecutivo n.°3495-MAG-SMINAE-MEIC y sus reformas. Agrega que con esta normativa no se otorgarán registros de IAGT y mucho menos de formulaciones que no se encuentren ya en el mercado. Respecto de los agroquímicos registrados y que se comercializan actualmente en el país, no existe ningún peligro adicional o resultante de la aplicación del mismo, en cuanto a la salud humana, el ambiente o la eficacia biológica del plaguicida. Por tanto, no es correcto sostener que, con la aplicación del decreto, los registros que se actualicen en sus expedientes supongan un riesgo adicional para la salud, el ambiente o la agricultura, pues todos, absolutamente todos los registros de IAGT que se otorguen, necesaria e indefectiblemente deben corresponder a alguna de las formulaciones que ya se venden en el mercado y sobre estas formulaciones, los Ministerios de Salud o Ambiente tiene amplias e indiscutibles competencias y facultades para adoptar las medidas pertinentes para evitar un daño a la salud o al ambiente.

La PGR reitera que ello no enerva el deber constitucional que, en virtud del principio precautorio, tienen las autoridades competentes de aplicar las potestades dispuestas en los arts. 25 y 30 de la Ley de Protección Fitosanitaria y el art. 5 de la Ley para la Importación y Control de la Calidad de Agroquímicos, de “denegar, suspender o cancelar el registro de sustancias químicas, biológicas o afines”, “restringir o prohibir la importación, el tránsito, el redestino, la fabricación, la formulación, el reenvase, el reempaque, el almacenamiento, la venta, la mezcla y la utilización de sustancias químicas, biológicas o afines y equipos de aplicación para uso agrícola, cuando se justifique por razones técnicas” y “prohibir la circulación u ordenar la destrucción de los productos que no cumplan con las normas de calidad, así como tomar otras medidas tendentes a mejorar la calidad de los agroquímicos.

La norma en cuestión, comparativamente con la anterior, dispone lo siguiente:

Reglamento para la actualización de la información de los expedientes de registro de ingrediente activo grado técnico y plaguicidas formulados, n.°39995-MAG Reforma Reglamento para la actualización de la información de los expedientes de registro de ingrediente activo grado técnico y plaguicidas formulados, n.°41481 – MAG ART. 7 Durante el plazo de vigencia de un registro, cuando los Ministerios competentes demuestren un riesgo inaceptable para la salud humana, el ambiente o la agricultura, el Servicio Fitosanitario del Estado restringirá o prohibirá su uso.

ART. 7 Durante el plazo de vigencia de un registro, cuando el SFE compruebe que alguno de los ingredientes activo grado técnico o formulaciones con registro vigente suponen un riesgo inaceptable para la salud humana, el ambiente o la agricultura, deberá iniciar de oficio el procedimiento correspondiente para la anulación del registro conforme a lo dispuesto en el ordenamiento jurídico vigente, así como las acciones que procuren la protección de la salud y el ambiente conforme a lo establecido en los artículos 2 inciso e, 5 inciso o, 30, siguientes y concordantes de la Ley de Protección Fitosanitaria.

(Así reformado por el artículo 6° del decreto ejecutivo N° 41481 del 10 de diciembre del 2018) En criterio de la Sala, contrario a lo manifestado por el accionante, que en realidad se trata de una reiteración de los anteriores vicios ya examinados, la norma en cuestión autoriza al SFE a iniciar los procedimientos administrativos correspondientes para la anulación del registro ‒recuérdese que esta normativa aplica a productos que ya están en uso en el mercado‒ y, más aún, reitera la posibilidad de ejercer las competencias legalmente otorgadas en la materia. El hecho de que en la reforma del decreto en cuestión no se cite expresamente a los “ministerios competentes”, sino que centralice la competencia fiscalizadora, tal y como está en la ley, no quiere decir de modo alguno que se desconozcan otras competencias legalmente otorgadas a otros ministerios y que les autorizarían a adoptar medidas administrativas en aras de salvaguardar la salud humana o el medio ambiente.

Recuérdese que el manejo del registro es competencia del SFE, por lo que resulta lógico que sea esta autoridad la encargada de iniciar el procedimiento correspondiente para la anulación del registro. Al respecto, se debe insistir en la facultad legal que está prevista en el art. 30 de la Ley de Protección Fitosanitaria que justamente le encarga al MAG la decisión de restringir o prohibir la importación, el tránsito, el redestino, la fabricación, la formulación, el reenvase, el reempaque, el almacenamiento, la venta, la mezcla y la utilización de sustancias químicas, biológicas o afines y equipos de aplicación para uso agrícola, cuando se justifique por razones técnicas y se considere que emplearlas es perjudicial para la agricultura, la salud o el ambiente. De modo que la norma reglamentaria impugnada es reflejo de esa potestad de policía que está prevista para el MAG.

Sin embargo, nada de lo dicho en el numeral impugnado hace que se dejen sin efecto otras competencias legales que, como se advirtió supra, son de orden público y podrían, por ejemplo, instar al MAG o presentar las pruebas correspondientes a efecto de que el SFE inicie el procedimiento que le atañe. Recuérdese, como ya se advirtió supra, que las medidas de protección fitosanitaria tienen raigambre en nuestro Estado Social de Derecho, pues procuran tutelar la salud (art. 21), la protección de los derechos del consumidor concretamente a la salud y al ambiente (art. 46), así como la estimulación de la producción agrícola de tanta importancia para nuestro país paralelamente con la protección del medio ambiente (art. 50). De manera que las autoridades deben llevar a cabo la fiscalización de modo conjunto.

Por ejemplo, la Ley General de Salud contiene las siguientes competencias a favor del Ministerio de Salud:

“Art.- 213.- Toda persona, natural o jurídica, que se ocupe en producir alimentos, deberá hacerlo en condiciones ambientales sanitarias y empleando técnicas de defensa o conservación aprobadas por la autoridad de salud, a fin de evitar, principalmente, la contaminación de tales productos y su peligrosidad debida a la presencia de residuos tóxicos proveniente de su tratamiento con plaguicidas u otros sistemas de defensa o conservación”.

Art.- 244.- Las personas naturales y jurídicas que importen, fabriquen, manipulen, almacenen, transporten, comercien, suministren o apliquen sustancias, mezclas de sustancias o productos denominados plaguicidas por la ley de sanidad vegetal, quedarán sujetas a las disposiciones reglamentarias que el Ministerio dicte de común acuerdo con el Ministerio de Agricultura para el resguardo de la salud de las personas de conformidad con esa ley, los interesados deberán registrar todo pesticida o producto destinado al control o exterminio de las infestaciones y solicitar permiso previo para operar cuando tales sustancias, mezclas de sustancias o productos que por su naturaleza o uso no queden incluidos en la ley mencionada fueren capaces de algún modo de producir intoxicaciones o daños serios a la salud de las personas o de los animales útiles o inofensivos al hombre.

Art. 245.- Las personas naturales o jurídicas que se dediquen al control de plagas, podrán operar sólo con permiso del Ministerio utilizando las sustancias, mezclas de sustancias, los productos y mezclas de productos autorizados por el Ministerio y con sujeción a las normas técnicas procedentes, a fin de evitar accidentes o daños a la salud de las personas que realicen tales tareas o de terceros”. (Lo destacado no corresponde al original).

Asimismo, la Ley Orgánica del Ambiente dispone lo siguiente:

“Artículo 59.- Contaminación del ambiente. Se entiende por contaminación toda alteración o modificación del ambiente que pueda perjudicar la salud humana, atentar contra los recursos naturales o afectar el ambiente en general de la Nación. La descarga y la emisión de contaminantes, se ajustará, obligatoriamente, a las regulaciones técnicas que se emitan. El Estado adoptará las medidas que sean necesarias para prevenir o corregir la contaminación ambiental.

Artículo 60.- Prevención y control de la contaminación. Para prevenir y controlar la contaminación del ambiente, el Estado, las municipalidades y las demás instituciones públicas, darán prioridad, entre otros, al establecimiento y operación de servicios adecuados en áreas fundamentales para la salud ambiental, tales como:

• a)El abastecimiento de agua para consumo humano.
• b)La disposición sanitaria de excretas, aguas servidas y aguas pluviales.
• c)La recolección y el manejo de desechos.
• d)El control de contaminación atmosférica.
• e)El control de la contaminación sónica.
• f)El control de sustancias químicas y radiactivas.

Estos servicios se prestarán en la forma que las leyes y los reglamentos específicos lo determinen, procurando la participación de la población y sus organizaciones.

Artículo 61.- Contingencias ambientales. La autoridad competente dictará las medidas preventivas y correctivas necesarias cuando sucedan contingencias por contaminación ambiental y otras que no estén contempladas en esta ley”. (Lo destacado no corresponde a la ley).

De este modo, corresponde advertir que el hecho de que el decreto impugnado concentre ciertas funciones de registro en el MAG y concretamente en el SFE, no desconoce o deja sin efecto otro tipo de competencias y habilitaciones legales previstas a favor del Ministerio de Salud y del MINAE en lo relativo al resguardo a la salud pública y el medio ambiente. Ya se advirtió anteriormente que el decreto bajo examen no puede entenderse como un cuerpo normativo aislado del resto del bloque de legalidad y de constitucionalidad y que la labor específica de actualizar la información de los registros y su revisión no supone dejar sin efecto el resto de competencias legales confiadas a otras carteras ministeriales.

Del mismo modo, no está de más reiterar lo señalado en el antecedente transcrito supra n.°2017-06668 en el sentido de que para enervar un registro previamente tramitado, sí se requiere de la demostración de un riesgo inaceptable para la salud humana, el ambiente o la agricultura y contempla una potestad de imperio de la administración pública como lo es la restricción o prohibición de uso de un registro, aunque exista una situación jurídica sustancial previa en favor del administrado, como lo es el registro. En esa medida, el registro otorgado puede modificarse si hay evidencia de un riesgo inaceptable, en cuyo caso, la Administración ‒entendida en sentido amplio‒ estaría posibilitada para ejercer las potestades de imperio e imponer medidas cautelares.

Por lo tanto, se descarta una lesión al principio precautorio invocado y se rechaza el agravio en cuestión.

XIV.- Sobre el art. 9 (que reforma y adiciona un nuevo art. 11 del decreto n.°39995).

El accionante acusa que siguiendo con el proceso de facilitación de registro y sin mediar ningún análisis que responda a un sustento técnico y científico de acuerdo a normas nacionales e internacionales, el Poder Ejecutivo se propone homologar los usos de un producto con otro que tenga similitud con el ingrediente activo, concentración y formulación, cuando en este caso particular lo mínimo que se puede realizar es la equivalencia química del ingrediente activo, pero como se refiere a un formulario deben ser analizados los coformulantes, mismos que se deben declarar y poder realizar el análisis de riesgo por parte de los ministerios de salud y ambiente y presentar un estudio de eficacia biológica respetando las reglas unívocas de la ciencia y la técnica.

El Ministro del MAG manifiesta que la asociación accionante no aporta más que una transcripción de partes de un informe de la CGR absolutamente descontextualizado y no aplicable a la situación concreta. Indica que la homologación de formulaciones planteada en el art. 11 del decreto impugnado está basado en el manual de especificaciones de la FAO y la OMS, para la elaboración de especificaciones de plaguicidas.

La norma impugnada establece lo siguiente:

Artículo 9.- Se reforma y adiciona un nuevo artículo 11 y se corre la numeración de los artículos posteriores:

‘ARTÍCULO 11. En un plazo de treinta y seis meses, contados a partir de la vigencia de esta reforma, los titulares de los registros de formulaciones con registro vigente, podrán solicitar al Servicio Fitosanitario del Estado, la homologación de la etiqueta y panfleto, respecto de otras formulaciones ya registradas del mismo tipo, con el mismo IAGT e igual concentración, en aspectos relacionadas con los usos autorizados, plagas, cultivos aprobados, dosis, modos de aplicación, rangos de aplicación e intervalos de aplicación.

El Servicio Fitosanitario del Estado, por medio del área de evaluación agronómica de la Unidad de Registros, en un plaza (sic) de treinta días hará una valoración de cada caso concreto y verificará, que el valor de las propiedades fisicoquímicas del producto formulado cumple con los parámetros establecidos en la reglamentación técnica vigente en el país o con la de FAO u otros organismos internacionales de referencia a las que presenta el material ya registrado. La resolución aprobando o denegando la solicitud, será dictada en un plazo de treinta días contados a partir de la presentación del informe de evaluación· agronómica. Junto con la solicitud de homologación, deberá aportarse las propiedades físicas químicas de la formulación, el panfleto y la etiqueta incorporando los cambios solicitados.” En criterio de la Sala la deficiencia en el argumento es que el accionante nuevamente pretende que sea este Tribunal el que disponga técnicamente cómo realizar el procedimiento para evaluar los productos respecto de otras formulaciones ya registradas del mismo tipo con el mismo IAGT e igual concentración. Esto responde a una decisión enteramente técnica respecto de la cual se carece de competencias para realizar una determinación. Luce, sin duda alguna, como una discusión de legalidad y no de constitucionalidad. Nótese que se está hablando de la homologación de etiquetas y panfletos en productos que tienen notables similitudes, por lo que no parece razonable solicitar, como lo pretende el accionante sin mayor fundamentación, un estudio de equivalencia química. En consecuencia, corresponde desestimar el agravio, sin perjuicio que esto se pueda discutir con mayor amplitud en las vías ordinarias de legalidad.

XV.- CONCLUSIÓN Corolario de las consideraciones realizadas, se impone declarar sin lugar la acción de inconstitucionalidad presentada.

Los magistrados Cruz Castro y Rueda Leal salvan el voto y declaran con lugar la acción por violación al derecho a un ambiente sano y ecológicamente equilibrado. Los magistrados Cruz Castro y Rueda Leal consigan notas por aparte.

XVI.- DOCUMENTACIÓN APORTADA AL EXPEDIENTE. Se previene a las partes que de haber aportado algún documento en papel, así como objetos o pruebas contenidas en algún dispositivo adicional de carácter electrónico, informático, magnético, óptico, telemático o producido por nuevas tecnologías, estos deberán ser retirados del despacho en un plazo máximo de treinta días hábiles contados a partir de la notificación de esta sentencia. De lo contrario, será destruido todo aquel material que no sea retirado dentro de este plazo, según lo dispuesto en el "Reglamento sobre Expediente Electrónico ante el Poder Judicial", aprobado por la Corte Plena en Sesión N° 27-11 del 22 de agosto del 2011, artículo XXVI y publicado en el Boletín Judicial N° 19 del 26 de enero del 2012, así como en el acuerdo aprobado por el Consejo Superior del Poder Judicial, en la Sesión N° 43-12 celebrada el 3 de mayo del 2012, artículo LXXXI.

POR TANTO:

Por mayoría, se declara sin lugar la acción de inconstitucionalidad.

Los magistrados Cruz Castro y Rueda Leal salvan el voto y declaran con lugar la acción por violación al derecho a un ambiente sano y ecológicamente equilibrado. Los magistrados Cruz Castro y Rueda Leal consigan notas por aparte.

Fernando Castillo V.

Fernando Cruz C. Paul Rueda L.

Luis Fdo. Salazar A Jorge Araya G.

Anamari Garro V. Aracelly Pacheco S.

Res. nro. 2023002389 Voto salvado de los magistrados Cruz Castro y Rueda Leal, con redacción del segundo. Con el respeto acostumbrado, salvamos el voto y declaramos con lugar la acción, por los siguientes motivos.

Como punto de partida, reiteramos el criterio que externamos en la sentencia nro. 2022-026651 de las 16:30 horas del 9 de noviembre de 2022, cuyas consideraciones son, en gran medida, aplicables al sub lite:

“1.- Atinente al uso referenciado de los datos para registro. La mayoría acude al “Código internacional de conducta sobre la distribución y utilización de plaguicidas. Directrices para el registro de plaguicidas” (abril 2010) para establecer la “aceptabilidad de registros, armonizados y claros, el uso de información disponible y aceptación mutua de datos, la existencia de mecanismos de intercambio de información entre las autoridades competentes” como elemento “toral” en esa normativa técnica y alegar la existencia del “principio de no repetición de estudios”. En ese sentido, transcribe el punto 3 del citado código:

“3. Los principios del registro de plaguicidas Las autoridades responsables, al manejar sus programas nacionales o regionales de registro, deberían seguir una serie de principios importantes que se practican a nivel internacional. La aceptación y el uso de estos principios asegurarán una mayor eficiencia, transparencia y un uso óptimo de los recursos durante el proceso de registro. Estos principios incluyen los siguiente:

Criterios y requisitos completos para registro, armonizados y claros; Uso de toda la información disponible y aceptación mutua de datos; Transparencia e intercambios de información; Evaluación hecha sobre bases científicas para determinar si se exigen medidas de precaución; Consideración de peligros; Evaluación y mitigación del riesgo basada en la situación local; Análisis de riesgo/beneficio, tomando en cuenta las alternativas disponibles; Monitoreo y evaluación post registro; Mecanismos para revisiones periódicas y no programadas de manera a dar respuesta a la nueva información que puede tener impacto en el estatus regulatorio; Protección de los derechos de propiedad intelectual de la solicitud.

La evaluación de los datos conservados en el archivo de registro debería respetar los estándares y procedimientos aceptados y acordados internacionalmente, en la medida que estén disponibles. Estos estándares deberían ser actualizados regularmente para asegurar su conformidad con los avances científicos actuales.

Es esencial que todos los pasos del proceso de registro sean transparentes, basados en documentos de criterios y orientación bien argumentados y publicados, con información completa compartida con el solicitante sobre el resultado de los diferentes pasos del proceso de registro. Las autoridades responsables deberían asegurar que los criterios y los requerimientos para registro están completos y claramente definidos. Lo mismo aplica para los estándares de aceptación de datos, para la calidad de datos, para la aceptabilidad de los productos plaguicidas formulados para usuarios y usos específicos, o para los criterios de degradabilidad o acumulación.

Los gobiernos deberían facilitar el intercambio de información entre autoridades responsables a través de las instituciones nacionales, de las organizaciones internacionales, regionales y sub-regionales así como los grupos del sector público. Deberían desarrollar la legislación y las regulaciones para permitir el intercambio de información con el público sobre los riesgos y los beneficios de los plaguicidas y también para facilitar la participación del público en el manejo de los plaguicidas del país.

Las autoridades responsables deberían, siempre que fuere posible, utilizar datos que han sido puestos bajo dominio público, y preferentemente aquellos que han sido revisados previamente, cuando se está considerando una solicitud de registro. De este modo, se puede minimizar el trabajo duplicado y uso ineficiente. Se recomienda la aceptación mutua de datos por diversas autoridades regulatorias sobre tópicos como la eficacia y los residuos, entre otros, siempre que se pueda establecer una sólida base para asegurar que los datos son importantes en relación con la situación que se está considerando” Hasta ahí llegó la cita de la mayoría. Consideramos que una valoración adecuada del caso requiere, por lo menos, la transcripción de los dos párrafos siguientes de ese mismo numeral:

“Además, las evaluaciones de peligrosidad generalmente son aplicables globalmente y están disponibles a partir de fuentes publicadas, incluyendo las evaluaciones por los pares de la Reunión Conjunta sobre Residuos de Plaguicidas FAO/OMS (JMPR). Éstas pueden ser utilizadas en la evaluación de un expediente, siempre que la propiedad de los datos sea tomada en cuenta adecuadamente.

Los países deberían evaluar plenamente la eficacia de los plaguicidas, su comportamiento, su destino final, su peligrosidad y riesgo en relación con las diversas condiciones anticipadas de uso en su país. Cualquier procedimiento de registro debería incluir una evaluación de los riesgos potenciales relacionados con el uso plaguicida para el que el plaguicida ha sido requerido. Las instrucciones de uso, como indicadas en la etiqueta, deberían cubrir estos riesgos y prescribir las medidas para su debida aplicación, almacenamiento, manejo y eliminación para mitigar dichos riesgos. Al hacerlo, las autoridades responsables deberían también garantizar que estas medidas puedan ser adoptadas realistamente por parte del usuario para el que el producto ha sido destinado. También se deberían considerar los requerimientos específicos bajo las políticas nacionales para el Manejo Integrado de Plaguicidas (MIP) [5] y el Manejo Integrado de los Vectores (MIV) [6].” (El subrayado es agregado).

A partir de lo anterior, contrario a lo que concluye la sentencia de mayoría, estimamos que la evaluación plena del plaguicida debe ser la regla. Nuestra lectura de ese ordinal es que la aceptación mutua de datos es una recomendación (la norma señala textualmente “Se recomienda la aceptación mutua de datos…”) con el propósito de evitar trámites excesivos, como sería el trabajo duplicado. Sin embargo, el reconocimiento de información referenciada no puede nunca sustituir la valoración plena del pesticida.

El carácter opcional de la aceptación mutua de datos se deriva también del numeral 12 del citado código, el cual supedita tal aceptación a la pertinencia y calidad de los datos:

“Aceptación mutua de datos. Si se han generado datos pertinentes de buena calidad en otros países, la autoridad responsable podría obviar el requerimiento de generación de datos locales. Esto es especialmente importante para las pruebas de eficacia, datos sobre residuos y estudios de campo medioambientales, todos los cuales probablemente requieren la implicación de instituciones de investigación nacionales (públicas);” Semejante pertinencia y calidad, o condiciones de equivalencia, se echan de menos en el decreto impugnado.

La oposición de los infrascritos al uso de información referenciada, en los términos de la norma impugnada, fue compartida por el entonces ministro de Ambiente y Energía, quien se expresó en este proceso en los siguientes términos:

“Este apartado pretende que aquellos IAGTs que no cuentan con información propia (los genéricos) se actualicen, y posteriormente se registren, con la presentación de información referenciada. Este procedimiento es contradictorio con la definición de información referenciada establecida en el Decreto Ejecutivo No. 40059-MAG-MINAE-S, la cual indica "4.32. información referenciada: Para la aplicación e interpretación de este reglamento es la información técnica del perfil de referencia, que puede ser utilizad a por la AC para evaluar la solicitud de un registro de IAGT por equivalencia y que no cuenta con plazo de protección vigente".

Por su parte, la definición de perfil de referencia indica:"4.49. Perfil o fuente de referencia: Es la información sobre la cual se basó el análisis de riesgo y para la cual se ha tomado una decisión regulatoria y otorgó el registro correspondiente, y que será utilizada como base para el registro de equivalencia, de conformidad con lo que establece este reglamento". La lectura integral de estas dos definiciones demuestra que no se puede determinar la equivalencia si no se cuenta con el perfil de referencia debidamente evaluado y registrado, sobre el cual se toma la información referenciada. Este procedimiento no se aplica, según lo que contempla el DE 39995 citado, lo cual contradice las disposiciones de la CGR. La Contraloría General de la República (CGR) en su informe FOE-AM-19/2004 señaló el incumplimiento de la normativa nacional e internacional por parte del SFE al tolerar que los registrantes presenten información de otros productos (información referenciada), sin realizar un análisis de equivalencia que compruebe si dicha información es aplicable a la nueva sustancia por registrar. Con base en su análisis, la CGR dispuso: "Su suspender de inmediato la práctica de registrar plaguicidas agrícolas utilizando para ello información correspondiente a otro producto previamente registrado, sin que se haya realizado un análisis de equivalencia de conformidad con las disposiciones que la FAO y la OMS ...". Así también, la Sala Constitucional en su Resolución N° 201101 6937 ordenó la anulación del inciso b, y la referencia en el párrafo penúltimo a dicho inciso "b)" del apartado 7.3.2, del artículo 2, del DE 33495-MAG-S-MINAE-MEIC, por cuanto en dicho numeral se permitía hacer la equivalencia a partir de un perfil de referencia con data incompleta. Peor aún sería permitir la actualización de un registro con datos referenciados que no tengan ninguna relación directa con el producto que se vaya a actualizar, lo cual estaría siendo permitido por este reglamento”.

Finalmente, concerniente al uso de evaluaciones existentes del mismo ingrediente activo y/o producto, nótese que el mencionado código reduce las posibilidades de tal práctica a casos concretos:

“6.3 Uso de evaluaciones existentes del mismo ingrediente activo y/o producto En caso que el solicitante tenga la propiedad de los datos o pueda justificar plenamente el derecho a usar los datos para su solicitud de registro, hay elementos de registros existentes que pueden ser utilizados para nuevas solicitudes basadas en los mismos ingredientes activos. Sin embargo, si los datos fueran propiedad de otro propietario y el candidato solicitante no pudiese justificar su derecho a utilizarlos, la autoridad responsable no debería utilizar los datos y la evaluación del primer registrante para aprobar el producto del segundo solicitante.” (El subrayado es agregado).

En ese tanto, consideramos que la regulación impugnada socaba la protección del ambiente y la salud pública al posibilitar el uso de información referenciada, en detrimento de una valoración plena del pesticida o producto.

2.- En cuanto a la disminución de requisitos. En cuanto a este tema, la mayoría de la Sala optó por estimar que la acción carece de adecuada fundamentación. Al respecto, indicamos, por un lado, que la falta de fundamentación debería ser advertida y prevenida por la Sala oportunamente, en los términos del artículo 80 de la Ley de la Jurisdicción Constitucional. Reconocemos que la falta de fundamentación puede lleva a que se declare sin lugar la acción al momento de ser conocida por el fondo. Sin embargo, tal proceder debería ocurrir únicamente cuando no se desprenda de los autos con claridad el reclamo es procedente, como ocurre en el sub lite.

Así, en torno a este tema, la Procuraduría General de la República manifestó:

“…de la lectura del artículo 1° del Decreto cuestionado es posible determinar que para el proceso de reválida allí dispuesto se exigen menos requisitos que los dispuestos en el proceso de reválida que establecía el Decreto 33495, pues en éste último se requería para todos los casos, el legajo de información confidencial, el legajo administrativo, así como los estudios de toxicidad aguda definidos en los incisos d.1.1, d.1.2, d.1.3, d.1.4, d.1.5, d.1.6, y los estudios de ecotoxicidad definidos en los incisos d.5.1.1, d.5.3.1, d.5.4.1, del apartado 7.2.

Nótese que para los casos en los que no haya cambiado el fabricante del producto, el Decreto impugnado solamente requiere la solicitud para la actualización del fabricante, el certificado de registro expedido por la autoridad del país de origen, el certificado de composición cuali-cuantitativa y comprobante de pago del arancel vigente.

Para los casos en los que el fabricante del producto haya cambiado, pese a que se exigen otros requisitos, éstos siguen siendo menos que los dispuestos por el Decreto 33495. Además, se permite que la información del legajo técnico sea presentada mediante información referenciada y exige estudios de toxicidad aguda únicamente cuando el ingrediente activo grado técnico contenga impurezas relevantes en niveles superiores de los estándares internacionales reconocidos, o que estén en el Anexo III del Convenio de Rotterdam, o en el Convenio de Estocolmo, o en el Protocolo de Montreal.

Es decir, en el proceso de reválida del Decreto 33495 se exigían ciertos requisitos técnicos que no han sido contemplados por el Decreto 39995, pese a que en los considerandos de éste último se reconoce que se trata de la actualización de productos que no han cumplido con los requisitos de información toxicológica, ecotoxicológica y de destino ambiental dispuestos en normativa internacional y exigidos a partir de la entrada en vigencia del Decreto 33495.” Por su parte, la directora de Dirección de Gestión de Calidad Ambiental del Ministerio de Ambiente y Energía se pronunció de la siguiente manera:

“El DE N° 39995-MAG fue emitido de manera arbitraria y unilateral por el MAG con el fin de completar los expedientes de los productos viejos, incluyendo el registro de los ingredientes activos grado técnico (IAGT) que respaldan a dichos formulados (que por normativa anterior no tenían que ser registrados), así como definir nuevos plazos de vigencia para estos productos viejos. Sin embargo, en un evidente incumplimiento de las disposiciones de la CGR en el informe FOE-AM-19/2004, NO se contempló la participación del MINAE ni del Ministerio de Salud, así como tampoco se solicitó a los administrados la presentación de la totalidad de los estudios requeridos para realizar la evaluación ambiental y de salud, establecidos en el DE N° 33495-MAG-S-MINAE-MEIC y el DE N° -40059-MAG-S-MINAE. De igual forma a como se establecía en el DE N° 24997 y la Ley N° 8702, tampoco se consideró que los insuficientes estudios requeridos en el DE 39995 fueran analizados por la autoridad competente en materia ambiental o de salud, lo que lleva a que estos productos se continúen comercializando sin un dictamen que garantice la protección del ambiente y de la salud humana.” (El subrayado es agregado. Oficio DIGECA-516-2018 del 19 de diciembre de 2018).

3.- Atinente al principio precautorio y la inversión de la carga de la prueba. Este tema fue abarcado en nuestro voto salvado a la sentencia nro. 2017-06668 de las 10:50 horas del 10 de mayo de 2017 en los siguientes términos:

“Voto salvado de los Magistrados Cruz Castro y Rueda Leal, con redacción del segundo. Con el respeto acostumbrado, nos separamos del criterio de mayoría por los siguientes motivos.

En su escrito de interposición, el accionante explica que el artículo 7 del Reglamento impugnado se contrapone al principio precautorio e invierte la carga de la prueba en materia ambiental. Llega a esta conclusión porque el numeral en cuestión obliga a que los ministerios competentes a que “…demuestren un riesgo inaceptable para la salud humana, el ambiente o la agricultura…” a fin de que el Servicio Sanitario pueda restringir o prohibir el uso de un registro.

En la sentencia, la mayoría de este Tribunal estimó que el reclamo no era procedente porque la norma cuestionada más bien tutelaba el ambiente. En ese sentido, la resolución arguye que el momento de aplicación del principio precautorio es durante la tramitación de la inscripción de un registro. Una vez inscrito el registro, será necesario demostrar el riesgo inaceptable señalado por la norma.

Como punto de partida, es menester recordar lo que esta Sala ha dispuesto con respecto al principio precautorio en materia ambiental:

“III.- La prevención del riesgo ambiental. Estableciéndose a nivel constitucional esta obligación del Estado, resulta importante apreciar cómo a nivel de los instrumentos internacionales de protección de los derechos humanos también se establecen obligaciones concretas que deben ser respetadas. En materia ambiental se ha definido el deber de prevención que debe existir en este ámbito; la Declaración de Río, adoptada en la Conferencia de las Naciones Unidas sobre el Medio Ambiente y el Desarrollo, dispone que:

"Principio 15.- Con el fin de proteger el medio ambiente, los Estados deberán aplicar ampliamente el criterio de precaución conforme a sus capacidades. Cuando haya peligro de daño grave e irreversible, la falta de certeza científica absoluta no deberá utilizarse como razón para postergar la adopción de medidas eficaces en función de los costos para impedir la degradación del medio ambiente".

La prevención pretende anticiparse a los efectos negativos, y asegurar la protección, conservación y adecuada gestión de los recursos. Consecuentemente, el principio rector de prevención se fundamenta en la necesidad de tomar y asumir todas las medidas precautorias para evitar o contener la posible afectación del ambiente o la salud de las personas. De esta forma, en caso de que exista un riesgo de daño grave o irreversible -o una duda al respecto-, se debe adoptar una medida de precaución e inclusive posponer la actividad de que se trate. Lo anterior debido a que en materia ambiental la coacción a posteriori resulta ineficaz, por cuanto de haberse producido el daño, las consecuencias biológicas y socialmente nocivas pueden ser irreparables, la represión podrá tener una trascendencia moral, pero difícilmente compensará los daños ocasionados al ambiente.

Tal como lo señala el instrumento internacional de cita como el mismo artículo cincuenta constitucional, es el Estado el llamado a efectuar esta labor de prevención, y así lo ha reconocido esta Sala al afirmar, mediante sentencia número 2001-6503, de seis de julio de dos mil uno, que:

“El párrafo tercero del numeral 50 Constitucional señala con toda claridad que el Estado debe garantizar, defender y preservar el derecho de todas persona a un ambiente sano y ecológicamente equilibrado; lo que implica afirmar que los entes públicos no sólo están en la obligación de hacer cumplir –a los particulares y otros entes públicos- la legislación ambiental, sino también, ante todo, que deben ajustar su accionar a los dictados de esos cuerpos normativos tutelares. Las instituciones del Estado son las primeras llamadas a cumplir con la legislación tutelar ambiental, sin que exista justificación alguna para eximirlas del cumplimiento de requisitos ambientales como, a manera de ejemplo, el estudio de impacto ambiental que exige la Ley Orgánica del Ambiente para las actividades que emprendan los entes públicos que, por su naturaleza, puedan alterar o destruir el ambiente.” (Sentencia 2010-11941 de 11:21 horas de 9 de julio de 2010) Según se desprende de la transcripción, la prevalencia del principio precautorio radica en la necesidad de evitar un daño grave e irreparable para el ambiente, obligando a que se adopten medidas que anticipen dicho daño. Es decir, ante la posibilidad de que se materialice un peligro irreversible o grave, surge el deber del Estado de actuar, requiriendo para ello tan solo la existencia de una duda razonable de riesgo para el ambiente.

Ahora bien, contrario a lo que defiende la mayoría, el principio precautorio no está limitado a una etapa del procedimiento administrativo, sino constituye uno de los principios que deben guiar el actuar administrativo en todo momento.

Consideramos que la interpretación realizada por la Sala podría significar la creación de una presunción a favor del registro y en contra del ambiente y la salud humana. De esta manera, se impondría al Estado la carga de probar la existencia del riesgo precitado, a fin de derribar tal presunción. Pero aun más, no basta con la sola demostración del riesgo, el Estado también debe probar, según la mayoría, que dicho riesgo es inaceptable, lo que dificulta todavía más la posibilidad de actuar a favor del ambiente y la salud humana.

Estas exigencias podrían ser irrazonables y desproporcionadas, toda vez que pueden transcurrir meses o años entre el momento en que surge la duda razonable y el momento en que se pueda demostrar la existencia de un riesgo de grado inaceptable. Este lapso de tiempo posibilitaría que se materializara el riesgo y se lesionara, de manera irreversible o grave, el ambiente y la salud humana. Así, podría haber una contradicción entre la situación de lege lata y los fines del principio precautorio, lo que justifica claramente que la acción sea cursada.

También podría llevar razón el accionante al criticar la inversión de la carga de la prueba. En este caso, el titular del registro tiene toda la información técnica relacionada con el producto y, además, es el sujeto interesado en mantener su uso legal en el país, lo que hace razonable imponerle la carga de probar su inocuidad para el ambiente y la salud humana.

Consideramos que todos estos temas deben ser analizados con mayor detenimiento por el pleno de esta Sala, otorgando audiencia a la Procuraduría General de la República y a las instancias competentes.

Además, vista la actual problemática ambiental y el consenso internacional en cuanto a la inminencia de problemas ambientales que amenazan a toda la raza humana (como el cambio climático, reconocido en el Acuerdo de París por 193 Estados), sorprende a los suscritos que la mayoría de esta Sala propugne la desaplicación del principio precautorio y, más bien, defienda que se impongan requisitos calificados a la Administración, cuando esta pretenda velar por el ambiente y la salud humana.

En virtud de los argumentos expuestos, salvamos el voto y ordenamos dar curso a la acción.” 4.- En cuanto a la participación ciudadana.

En la sentencia nro. 2021-25386 de las 13:10 horas del 10 de noviembre de 2021 nos referimos a la participación ciudadana en los siguientes términos:

“Como se consignó en el voto salvado a la sentencia n.º 2017-1163 de las 9:40 horas del 27 de enero de 2017, estimamos que del ordinal 9 de la Constitución Política se extrae que la participación ciudadana, allende de un principio general, se ha instituido como un verdadero derecho fundamental a la luz del marco convencional que acompaña e integra nuestro régimen de derechos fundamentales.

Justamente, en la sentencia n.º 2013-017305 de las 11:32 horas del 20 de diciembre de 2013, la Sala Constitucional considera que el derecho a la participación ciudadana en la toma de decisiones se ha convertido en uno de los pilares fundamentales sobre los que descansa el sistema democrático. En nuestro país, el legislador constitucional recogió este derecho en el artículo 9 de la Constitución Política al disponer que el Gobierno de la República sea popular, representativo, participativo, alternativo y responsable (destacado no corresponde al original), según la reforma propiciada por ley n.° 8364 de 1º de julio de 2003, publicada en La Gaceta n.º 146 de 31 de julio de 2003. Este mandato de la Ley Fundamental, en particular la cualidad de “participativo”, ha orientado un posterior desarrollo normativo constitucional e infra constitucional. Así, se ha establecido una serie de mecanismos que buscan que el derecho al gobierno participativo pueda ser aplicado en forma eficaz y efectiva, de manera que no quede únicamente como un derecho de papel; ejemplos de lo anterior son el referéndum para la aprobación o derogación de leyes y reformas parciales a la Constitución, o la iniciativa popular en la formación de leyes (véase, entre otras, la sentencia número 2005-05649 de las 14:39 horas del 11 de mayo del 2005).

El derecho al gobierno participativo no solo encarna un reconocimiento del más alto rango jurídico-positivo a la función del control político por parte de los habitantes de la República, sino que, además, significa una revalorización del papel de estos en los procesos de formulación, aplicación y control de la política pública. Por voluntad del legislador constituyente, que esta Sala no debe ni puede desconocer, el derecho al gobierno participativo se erige como pilar fundamental de nuestro régimen democrático (cuestión erróneamente desconocida por el voto de minoría, que a la participación ciudadana le baja la categoría de derecho a principio general en clara contraposición a la línea jurisprudencial de esta Sala, como más adelante se demuestra), lo que resulta conteste con un sistema político basado en la tolerancia, el pluralismo y el respeto a la libertad.

Como indicamos supra, esta categorización del gobierno participativo o de la participación ciudadana como derecho, se explica a través del respaldo convencional contenido en varios instrumentos internacionales de derechos humanos.

Verbigracia, el artículo 21 de la Declaración Universal de los Derechos Humanos de 1948 dispone que “toda persona tiene derecho a participar en el gobierno de su país, directamente o por medio de representantes libremente escogidos” (destacado no corresponde al original).

Concordante con lo anterior, el numeral 25 del Pacto Internacional de Derechos Civiles y Políticos reconoce de modo expreso el derecho de los ciudadanos: “(…) de participar en la dirección de los asuntos públicos, directamente o por medio de representantes libremente elegidos”.

En igual sentido, la Carta Democrática Interamericana señala en su ordinal 5 que: “La democracia representativa se refuerza y profundiza con la participación permanente, ética y responsable de la ciudadanía en un marco de legalidad conforme al respectivo orden constitucional”.

De manera más vehemente, el artículo 6 de esta Carta estatuye que: “La participación de la ciudadanía en las decisiones relativas a su propio desarrollo es un derecho y una responsabilidad. Es también una condición necesaria para el pleno y efectivo ejercicio de la democracia. Promover y fomentar diversas formas de participación fortalece la democracia”. (Destacado no corresponde al original).

El Consejo de Derechos Humanos de las Naciones Unidas también reconoció la participación ciudadana como fundamental para la protección del ambiente:

“Reconociendo también que el ejercicio de los derechos humanos, entre ellos la libertad de buscar, recibir y difundir información y de participar efectivamente en la dirección de los asuntos gubernamentales y públicos y el derecho a un recurso efectivo, es fundamental para la protección de un medio ambiente limpio, saludable, sin riesgos y sostenible,” (Consejo de Derechos Humanos, 46° periodo de sesiones, A/HRC/RES/46/7 de 23 de marzo de 2021).

También resulta importante resaltar que, recientemente, el Consejo de Derechos Humanos de las Naciones Unidades, en la resolución A/HRC/RES/48/13 de 8 de octubre de 2021, le ha venido a otorgar el estatus de derecho humano a la participación efectiva en materia ambiental. En tal sentido, señaló:

“Reconociendo que el ejercicio de los derechos humanos, entre ellos los derechos a buscar, recibir y difundir información y a participar efectivamente en la dirección de los asuntos gubernamentales y públicos y en la adopción de decisiones relativas al medio ambiente, así como el derecho a un recurso efectivo, es fundamental para la protección de un medio ambiente limpio, saludable y sostenible.”. (El resaltado no corresponde al original).

Por su parte, en la Opinión Consultiva OC-23/17 del 15 de noviembre de 2017, la Corte Interamericana de Derechos Humanos destacó que:

“226. La participación pública representa uno de los pilares fundamentales de los derechos instrumentales o de procedimiento, dado que es por medio de la participación que las personas ejercen el control democrático de las gestiones estatales y así pueden cuestionar, indagar y considerar el cumplimiento de las funciones públicas. En ese sentido, la participación permite a las personas formar parte del proceso de toma de decisiones y que sus opiniones sean escuchadas. En particular, la participación pública facilita que las comunidades exijan responsabilidades de las autoridades públicas para la adopción de decisiones y, a la vez, mejora la eficiencia y credibilidad de los procesos gubernamentales. Como ya se ha mencionado en ocasiones anteriores, la participación pública requiere la aplicación de los principios de publicidad y transparencia y, sobre todo, debe ser respaldado por el acceso a la información que permite el control social mediante una participación efectiva y responsable” (el destacado fue adicionado).

Tesitura que también había sido adoptada en la sentencia de 19 de septiembre de 2006, relativa al caso “Claude Reyes y otros vs. Chile”, en la que se dispuso:

“86. En este sentido, el actuar del Estado debe encontrarse regido por los principios de publicidad y transparencia en la gestión pública, lo que hace posible que las personas que se encuentran bajo su jurisdicción ejerzan el control democrático de las gestiones estatales, de forma tal que puedan cuestionar, indagar y considerar si se está dando un adecuado cumplimiento de las funciones públicas. El acceso a la información bajo el control del Estado, que sea de interés público, puede permitir la participación en la gestión pública, a través del control social que se puede ejercer con dicho acceso. 87. El control democrático, por parte de la sociedad a través de la opinión pública, fomenta la transparencia de las actividades estatales y promueve la responsabilidad de los funcionarios sobre su gestión pública. Por ello, para que las personas puedan ejercer el control democrático es esencial que el Estado garantice el acceso a la información de interés público bajo su control. Al permitir el ejercicio de ese control democrático se fomenta una mayor participación de las personas en los intereses de la sociedad.”. (El destacado fue adicional).

Así las cosas, este reconocimiento convencional a la participación ciudadana incide hermenéuticamente en su naturaleza jurídica, puesto que de principio constitucional lo transforma en verdadero derecho fundamental colectivo.

De este modo, la participación ciudadana representa un aspecto esencial del modelo democrático y republicano de este siglo, en el que el control ciudadano, la transparencia y la rendición de cuentas destacan como elementos expresivos de este tipo de régimen político, lo que a su vez confiere mucha mayor legitimidad a la toma de decisiones políticas, cuestión clave cuando de gobernabilidad se trata. Así, en el marco de este tipo de régimen ‑esto es, con activa y plena participación ciudadana‑, el gobierno participativo impacta con mayor intensidad, favoreciendo la toma de decisiones a través de medios más abiertos y transparentes.

Precisamente, uno de los mecanismos ideados para cumplir lo dispuesto en el numeral 9 constitucional es la audiencia pública, a través de la cual las personas interesadas pueden hacer valer sus derechos o manifestar su criterio, participando de manera activa en temas de relevancia nacional o local, y poniendo en conocimiento de la Administración todas aquellas anomalías o disconformidades en relación con algún proyecto por desarrollar.

Así las cosas, la audiencia pública es un instrumento típico de una democracia republicana, mediante la cual se fomenta la participación del ciudadano en el proceso de toma de decisiones públicas. Por su significado, la audiencia debe efectuarse de tal forma que garantice la mayor participación posible de las personas que puedan verse afectadas, de ahí que cualquier acción u omisión que obstaculice lo anterior configura una abierta vulneración al derecho constitucional a la participación ciudadana (véase, entre otras, la sentencia número 2009-018223 de las 12:34 horas del 27 de noviembre de 2009).

En cuanto al carácter participativo de la audiencia pública, como se indicó, el ordinal 9 de la propia Constitución Política obliga a ello, pues la calificación “participativo” ahí dispuesta implica, entre otros aspectos, que el Gobierno debe ser un articulador de lo definido por deliberación popular, cuando ello es obligatorio, al tiempo que en la formulación de la política pública, dentro de las posibilidades que el marco jurídico-positivo vigente plantee, está obligado a escuchar el criterio de individuos o grupos afectados, sea este vinculante o no.

En otras palabras, en la democracia republicana actual, los ciudadanos gozan, por mandato constitucional, ya no solo del derecho al voto para ejercer su derecho al gobierno participativo, sino de cantidad de instrumentos de diversa naturaleza para coadyuvar en la toma de decisiones gubernativas y el control político, lo que propicia que puedan ejercer influencia directa en las grandes decisiones públicas.

Dentro de este contexto, interesa resaltar que este Tribunal, en la sentencia n.° 2018004117 de las 9:15 horas del 13 de marzo de 2018, realizó un desarrollo respecto a la consulta pública en materia ambiental, destacando que este mecanismo es un pilar en la toma de decisiones relaciones con el medio ambiente. Asimismo, a manera de soft law, acudió a un instrumento particularmente relevante en materia de acceso a la información ambiental y participación ciudadana: el “Convenio sobre el acceso a la información, la participación ciudadana y el acceso a la justicia en la toma de decisiones en temas ambientales”, mejor conocido como “Convenio de Aarhus”. En tal sentido, en el referido pronunciamiento se indicó:

“La Convención de Aarhus, por su parte, en el artículo 6.2.3.4 dispone:

“2. Cuando se inicie un proceso de toma de decisiones respecto del medio ambiente, se informará al público interesado como convenga, de manera eficaz y en el momento oportuno, por medio de comunicación pública o individualmente, según los casos, al comienzo del proceso. Las informaciones se referirán en particular a:

• a)La actividad propuesta, incluida la solicitud correspondiente respecto de la que se adoptará una decisión; b) La naturaleza de las decisiones o del proyecto de decisión que podrían adoptarse; c) La autoridad pública encargada de tomar la decisión; d) El procedimiento previsto, en particular, los casos en que estas informaciones puedan facilitarse:
• i)La fecha en que comenzará el procedimiento; ii) Las posibilidades que se ofrecen al público de participar en el mismo; iii) La fecha y el lugar de toda audiencia pública prevista; iv) La autoridad pública a la que cabe dirigirse para obtener informaciones pertinentes ante la que se hayan depositado esas informaciones para que el público pueda examinarlas; v) La autoridad pública o cualquier otro organismo público o competente al que puedan dirigirse observaciones o preguntas y el plazo previsto para la comunicación de observaciones o preguntas; vi) La indicación de las informaciones sobre el medio ambiente relativas a la actividad propuesta que están disponibles; y e) El hecho de que la actividad sea objeto de un procedimiento de evaluación del impacto nacional o transfronterizo sobre el medio ambiente.

3. Para las diferentes fases del procedimiento de participación del público se preverán plazos razonables que dejen tiempo suficiente para informar al público de conformidad con el párrafo 2 supra y para que el público se prepare y participe efectivamente en los trabajos a lo largo de todo el proceso de toma de decisiones en materia ambiental.

4. Cada Parte adoptará medidas para que la participación del público comience al inicio del procedimiento, es decir, cuando todas las opciones y soluciones son aún posibles y cuando el público pueda ejercer una influencia real.” De conformidad con lo expuesto, debe propiciarse la consulta de manera transparente y con la mayor información posible. Esto genera una mejor administración de los recursos naturales, contribuye a la transparencia y al adecuado manejo de fondos públicos. Recordemos que el asunto ambiental es un tema de todos los miembros de la sociedad, no solamente del gobierno, por lo que también corresponde a cada ciudadano velar por la conservación del ambiente y procurar un desarrollo sostenible. Es por ello que debe abarcar en forma integral los diferentes sectores de la población (…)”. (El destacado fue adicional).

En adición, en el pronunciamiento aludido, la Sala subrayó que la audiencia ciudadana, por tratarse de una manifestación del principio democrático, no debe convertirse en una simple formalidad que simple y llanamente debe ser agendada, aunque tampoco debe instrumentalizarse como un mero obstáculo para el dictado de una decisión administrativa.

Relacionado con lo anterior, esta Sala ha señalado de modo reiterado, que la Constitución se caracteriza por su supremacía y su eficacia directa e inmediata, merced a las cuales los derechos y garantías que confiere resultan directamente exigibles y vinculantes para todos los Poderes Públicos. Así, en la sentencia n.° 1992-3194 de las 16:00 horas del 27 de octubre de 1992 se puntualizó:

“(…) La Constitución Política en su unánime concepción contemporánea, no sólo es “suprema” en cuanto criterio de validez de sí misma y del resto del ordenamiento jurídico, sino también conjunto de normas y principios fundamentales jurídicamente vinculantes, por ende, exigibles por sí mismos, frente a todas las autoridades públicas, y a los mismos particulares, sin necesidad de otras normas o actos que los desarrollen o hagan aplicables salvo casos calificados de excepción, en que sin ellos resulta imposible su aplicación-; con la consecuencia de que las autoridades tanto administrativas como jurisdiccionales- tienen la atribución-deber de aplicar directamente el Derecho de la Constitución en su pleno sentido, incluso en ausencia de norma de rango inferior o desaplicando las que se le opongan.” Por su parte, en la sentencia n.° 1995-1185 de las 14:33 horas del 2 de marzo de 1995, este Tribunal confirmó:

“Si la Constitución Política tiene un carácter normativo supremo, debe efectivamente conformar y condicionar la validez y eficacia de toda norma inferior o subordinada, y sirve de parámetro para legitimar o no la actuación de cualquier autoridad pública y hasta de los sujetos privados.... El principio de supremacía de la Constitución, en el caso costarricense, no solamente lo tenemos expresamente consagrado en el artículo 10, sino que de modo clarísimo, complementado respecto del órgano encargado de mantenerla o preservarla, según lo que adelante analizaremos. Esto que hemos expresado hasta ahora gira alrededor de que la Constitución tiene una eficacia directa y vincula sin necesidad de intermediación de ninguna otra norma. Y, es por ello, que toda autoridad, en general, tiene capacidad y poder para aplicar, desarrollar y expandir los derechos fundamentales contenidos en la Constitución Política. Si esto no fuera así, toda la argumentación acerca de la jerarquía de las normas, principios y valores constitucionales, caería convertida en una fantasía insubsistente. Sería mera ciencia ficción, una entelequia, en la que simultáneamente existen dos mundos jurídicos ubicados en planos diferentes y sin comunicación entre sí.” En conclusión, la participación ciudadana constituye un derecho constitucional y convencional, que se erige como una cualidad del sistema democrático republicano. Al respecto, los derechos consagrados en la Ley Fundamental, en diverso grado según su contenido sea más o menos programático, tienen una eficacia directa y vinculan sin necesidad de norma alguna. Incluso, su efectividad a través del desarrollo normativo infra constitucional y la aplicación de este no es ajena al control jurisdiccional de constitucionalidad, cuando se advierten regulaciones, actuaciones u omisiones que representan una lesión al núcleo duro (Kernbereich) de ese bien constitucional.” En el sub lite, estimamos que el decreto impugnado lesiona el derecho a la participación ciudadana en temas de máxima importancia para la población, como son el ambiente y la salud pública. La relevancia de la participación ciudadana en esta materia es reconocida en el ya citado “Código internacional de conducta sobre la distribución y utilización de plaguicidas. Directrices para el registro de plaguicidas”, cuyo punto 3 (Los principios del registro de plaguicidas) señala:

“Los gobiernos deberían facilitar el intercambio de información entre autoridades responsables a través de las instituciones nacionales, de las organizaciones internacionales, regionales y sub-regionales así como los grupos del sector público. Deberían desarrollar la legislación y las regulaciones para permitir el intercambio de información con el público sobre los riesgos y los beneficios de los plaguicidas y también para facilitar la participación del público en el manejo de los plaguicidas del país.” (El subrayado es agregado). La participación ciudadana también es incluida en su punto 10 (Coordinación y colaboración):

“10.1.3 Comunidad regulada Debería haber diálogos periódicos entre la autoridad responsable y la comunidad regulada, incluyendo la industria de plaguicidas, los vendedores de plaguicidas, operadores profesionales de control de plagas, agencias de publicidad de plaguicidas y el público en general, para que reciban retroalimentación y sugerencias sobre la implementación y la aplicación del registro de plaguicidas en el país. La autoridad responsable debería alentar la industria plaguicida para que desarrolle productos plaguicidas con riesgo bajo así como actividades de orientación sobre el producto.

10.1.4 Sociedad civil La autoridad responsable puede tener un diálogo frecuente con los representantes de la sociedad civil para abordar temas relacionados al registro de plaguicidas en el país. Los grupos de la sociedad civil pueden en particular ser importantes para suministrar retroalimentación sobre el uso de los plaguicidas, y sobre los problemas reales y potenciales que pueden producirse.” (El subrayado es agregado).” Adicionalmente, en lo que respecta al caso concreto, establecemos los siguientes vicios que ameritan declarar la inconstitucionalidad del decreto.

En cuanto a la disminución de requisitos para la aprobación de la valida, determinamos que el artículo 1 no exige estudios de toxicidad aguda y de ecotoxicidad, como lo hacía el decreto 33495. Además, el artículo 1.1 eliminó la solicitud para la actualización de fabricante, el certificado de registro expedido por la autoridad del país de origen y el refrendo de un químico para el certificado de composición cuali-cuantitativa. El artículo 1.2 eliminó el certificado de registro expedido por la autoridad del país de origen.

Asimismo, en cuanto al uso de información referenciada, hacemos nuestras las precisiones de la Procuraduría General de la República:

“…si bien la Procuraduría no es un órgano técnico en la materia, sí puede indicarse que aunque el Decreto impugnado modifica los artículos 1.2.b y 6 del Decreto 39995 que permitían registrar productos mediante información referenciada, mantiene esa posibilidad, pues en el artículo 1.2.c permite el uso de especificaciones internacionales para acreditar que el material técnico que se pretende actualizar no cuenta con impurezas relevantes, indicando en el considerando quinto que las especificaciones y estándares internacionales son una referencia técnica y científica para determinar que los ingredientes activos grado técnico no contienen impurezas relevantes en niveles superiores a los estándares o especificaciones internacionales, y que solo esas impurezas relevantes son las que tienen relevancia toxicológica o ecotoxicológica que pueden causar una afectación a la salud o al ambiente.

En ese mismo sentido, en el artículo 3° dispone que a los plaguicidas formulados que no cuenten con un registro de ingrediente activo grado técnico asociado, se le otorgará ese registro de manera directa cuando el fabricante de ese ingrediente activo haya sido actualizado; el artículo 6° dispone que cumplidos los requisitos se otorgará el registro por diez años y que, durante ese plazo, el SFE verificará que los registros ya aprobados de ingrediente activo grado técnico tienen equivalencia química con el perfil de referencia de ese ingrediente activo y que, en ausencia de ese perfil, debe verificarse que no contienen impurezas relevantes; y el artículo 11 avala la homologación de etiquetas y panfletos con los de otros productos ya registrados que tengan el mismo ingrediente activo e igual concentración, sin contemplarse los efectos que podrían tener los demás componentes del producto o la forma o método de elaboración.

En la norma impugnada no se establece de qué manera será verificable la información, cómo determinar cuál especificación internacional puede ser utilizada, la forma de determinar la equivalencia de productos, ni si el perfil de referencia a utilizar debe ser un registro que cuente con información completa, y por tanto, que abarque los estudios de toxicidad aguda, ecotoxicidad, toxicología crónica, ecotoxicológicos y otros estudios sobre el medio abiótico como lo exige el artículo 5° de la Ley para la Importación y Control de la Calidad de Agroquímicos y el Manual sobre Desarrollo y Empleo de las Especificaciones de la FAO y de la OMS para Plaguicidas.

De ahí que, tal y como se indicó en el informe anterior, al no establecerse con precisión las reglas a las que la autoridad competente debe ajustarse para verificar la información, es posible que se permita la actualización de registros con información referenciada que no cumple con los requisitos indicados, y, por tanto, ello implicaría la actualización de registros de productos sin una evaluación previa acerca de los riesgos ambientales y sanitarios de su aplicación.” En virtud de lo expuesto, determinamos que el decreto impugnado contraviene el bloque de constitucionalidad y lesiona el derecho a un ambiente sano y ecológicamente equilibrado. Por ello, salvamos el voto y declaramos con lugar la acción.

Fernando Cruz C. Paul Rueda L.

Res. nro. 2023002389 Nota del magistrado Rueda Leal. Tal como lo he expresado en otros casos, estimo que una cualidad del interés difuso consiste precisamente, en que su afectación es general -esto es, incide en toda una población o en amplios sectores de ella- dentro de un contexto, donde no se precisa que los sujetos perjudicados se conozcan entre sí (incluso podrían carecer de nexo o relaciones jurídicas entre ellos), pero sí se requiere de la presencia de una misma situación de daño o peligro a un bien constitucional que, por igual y sin necesidad de individualización alguna, comprende y aglomera a toda una sociedad en abstracto. Su defensa tiene como finalidad satisfacer una necesidad de la sociedad como tal, por ello, es trascendente a la de un ser humano individual o colectivamente considerado. En sentencia nro. 2019-17397 de las 12:54 horas del 11 de setiembre de 2019, este Tribunal reiteró lo siguiente:

“(…) En segundo lugar, se prevé la posibilidad de acudir en defensa de "intereses difusos"; este concepto, cuyo contenido ha ido siendo delineado paulatinamente por parte de la Sala, podría ser resumido en los términos empleados en la sentencia de este tribunal número 3750-93, de las quince horas del treinta de julio de mil novecientos noventa y tres) "… Los intereses difusos, aunque de difícil definición y más difícil identificación, no pueden ser en nuestra ley -como ya lo ha dicho esta Sala los intereses meramente colectivos; ni tan difusos que su titularidad se confunda con la de la comunidad nacional como un todo, ni tan concretos que frente a ellos resulten identificados o fácilmente identificables personas determinadas, o grupos personalizados, cuya legitimación derivaría, no de los intereses difusos, sino de los corporativos que atañen a una comunidad en su conjunto. Se trata entonces de intereses individuales, pero a la vez, diluidos en conjuntos más o menos extensos y amorfos de personas que comparten un interés y, por ende reciben un perjuicio, actual o potencial, más o menos igual para todos, por lo que con acierto se dice que se trata de intereses iguales de los conjuntos que se encuentran en determinadas circunstancias y, a la vez, de cada una de ellas. Es decir, los intereses difusos participan de una doble naturaleza, ya que son a la vez colectivos -por ser comunes a una generalidad- e individuales, por lo que pueden ser reclamados en tal carácter".

En síntesis, los intereses difusos son aquellos cuya titularidad pertenece a grupos de personas no organizadas formalmente, pero unidas a partir de una determinada necesidad social, una característica física, su origen étnico, una determinada orientación personal o ideológica, el consumo de un cierto producto, etc. El interés, en estos casos, se encuentra difuminado, diluido (difuso) entre una pluralidad no identificada de sujetos. En estos casos, claro, la impugnación que el miembro de uno de estos sectores podría efectuar amparado en el párrafo 2° del artículo 75, deberá estar referida necesariamente a disposiciones que lo afecten en cuanto tal. Esta Sala ha enumerado diversos derechos a los que les ha dado el calificativo de "difusos", tales como el medio ambiente, el patrimonio cultural, la defensa de la integridad territorial del país y del buen manejo del gasto público, entre otros. Al respecto deben ser efectuadas dos precisiones: por un lado, los referidos bienes trascienden la esfera tradicionalmente reconocida a los intereses difusos, ya que se refieren en principio a aspectos que afectan a la colectividad nacional y no a grupos particulares de ésta; un daño ambiental no afecta apenas a los vecinos de una región o a los consumidores de un producto, sino que lesiona o pone en grave riesgo el patrimonio natural de todo el país e incluso de la Humanidad; del mismo modo, la defensa del buen manejo que se haga de los fondos públicos autorizados en el Presupuesto de la República es un interés de todos los habitantes de Costa Rica, no tan solo de un grupo cualquiera de ellos. Por otra parte, la enumeración que ha hecho la Sala Constitucional no pasa de una simple descripción propia de su obligación –como órgano jurisdiccional- de limitarse a conocer de los casos que le son sometidos, sin que pueda de ninguna manera llegar a entenderse que solo pueden ser considerados derechos difusos aquellos que la Sala expresamente haya reconocido como tales; lo anterior implicaría dar un vuelco indeseable en los alcances del Estado de Derecho, y de su correlativo "Estado de derechos", que –como en el caso del modelo costarricense- parte de la premisa de que lo que debe ser expreso son los límites a las libertades, ya que éstas subyacen a la misma condición humana y no requieren por ende de reconocimiento oficial. Finalmente, cuando el párrafo 2° del artículo 75 de la Ley de la Jurisdicción Constitucional habla de intereses "que atañen a la colectividad en su conjunto", se refiere a los bienes jurídicos explicados en las líneas anteriores, es decir, aquellos cuya titularidad reposa en los mismos detentadores de la soberanía, en cada uno de los habitantes de la República.

No se trata por ende de que cualquier persona pueda acudir a la Sala Constitucional en tutela de cualesquiera intereses (acción popular), sino que todo individuo puede actuar en defensa de aquellos bienes que afectan a toda la colectividad nacional, sin que tampoco en este campo sea válido ensayar cualquier intento de enumeración taxativa” (véase la sentencia No. 2007- 01145).” En consonancia con lo expuesto y sostenido por este Tribunal en su jurisprudencia, se trata entonces de intereses individuales, pero a la vez, diluidos en conjuntos más o menos extensos y amorfos de personas que comparten un interés y, por ende, reciben un perjuicio, actual o potencial, más o menos igual para todos, por lo que con acierto se dice que se trata de intereses iguales de los conjuntos que se encuentran en determinadas circunstancias y, a la vez, de cada una de ellas. Es por ello, precisamente, que, a partir de la sentencia n.° 2021-2185 de las 12:51 horas del 3 de febrero de 2021, considero, a diferencia de la Mayoría de este Tribunal, que algunos de estos intereses pueden estar plasmados en un caso particular en concreto, sin perder por ello su condición de interés difuso, tal como ocurre con la protección al ambiente, cuyo impacto afecta a una persona y a todos en general; y puede ser individualizada tal afectación en una situación en particular, como por ejemplo, la construcción de una fábrica en un sector vecino determinado, sin los estudios ambientales respectivos, cuyos efectos negativos incidan en la capa de ozono del planeta. Indudablemente el resultado de un reclamo o proceso que pueda plantear un vecino contra esa fábrica, no solo incidirá en sus intereses propios, sino también en el resto de la colectividad. Por ello, constituye un interés difuso; y, sin embargo, también es objeto de una situación particular individualizada. Ahora bien, ello no quiere decir, en modo alguno, que en toda situación invocada se pueda alegar la existencia de un interés difuso, aunque este pueda ser objeto de una situación particular. Recordemos que para que un interés sea considerado “difuso”, no solo debe afectar una colectividad, sino también debe difuminarse, difundirse en esa colectividad. Si no produce tal efecto, no puede ser considerado un interés difuso. En este caso, el interés difuso alegado por los accionantes es la protección al ambiente. Por este motivo y con base en las precisiones recién efectuadas, conozco el caso por el fondo.

Paul Rueda L.

Res. N° 2023-002389 NOTA DEL MAGISTRADO CRUZ CASTRO.- La importancia de la protección del derecho al ambiente, a la salud y a la seguridad alimentaria, y en aplicación de los principios constitucionales ambientales de progresividad y no regresión, principio precautorio, principio preventivo, principio in dubio pro natura, y principio de objetivación en materia de regulación de plaguicidas.

Tal como lo he estimado en otros casos donde el tema de plaguicidas ha llegado a discusión de esta Sala, resulta relevante partir del antecedente jurisprudencial sentencia n°2011-016937 de las 14:36 horas del 07 de diciembre del 2011: (https://nexuspj.poder-judicial.go.cr/document/sen-1-0007-532977). Aquí la Sala delineó el marco constitucional bajo el cual se debe analizar un reglamento para el registro, uso y control de plaguicidas, cuando en la acción de inconstitucionalidad presentada en contra del Decreto Ejecutivo número 33495-MAG-S-MINAE-MEIC del 31 de octubre del 2006 se indicó lo siguiente:

VI.- LA SEGURIDAD ALIMENTARIA, LA TRAZABILIDAD O RASTREABILIDAD, Y LA APLICACIÓN DEL PRINCIPIO PRECAUTORIO. Esta Sala, en el resolución 13924-2011 de las 17:59 horas del 10 de mayo, se refirió al tema de la seguridad agroalimentaria: “El derecho a la alimentación ha sido incorporado en la mayor parte de los ordenamientos jurídicos como derecho humano, hoy reconocido en los Tratados Internacionales e incluso elevado en muchos países a rango constitucional. El derecho agroalimentario debe entenderse como el conjunto de normas especiales, ordenadas sistemáticamente, que regulan el producto agroalimentario y su cadena productiva en todas sus fases, desde la producción hasta el consumo, controlando las etapas de la empresa agroalimentaria y su actividad productiva con el propósito de garantizar el consumo alimenticio de productos sanos e inocuos, en aras de proteger la salud de las personas, de los animales y de las plantas, o bien, procurar el abastecimiento alimentario de la población. De la anterior definición se deriva la necesidad del intérprete de contribuir a la formulación y sistematización de esas normas especiales, a fin de establecer, dentro del marco de una teoría general del derecho agroalimentario, cuál es el objeto, los sujetos, las posibles fuentes normativas, las actividades y principios generales que deben orientar la disciplina. Las exigencias de calidad y sanidad imponen a su vez exigencias de trazabilidad o rastreabilidad del producto durante toda la cadena agroalimentaria. En los diferentes ámbitos de la actividad se recoge el enfoque global «de la granja a la mesa», que caracteriza a esta política y consolida el carácter indivisible de la cadena alimentaria, y se centra en el decisivo papel que desempeña el Servicio Nacional de Salud Animal. Las condiciones de todo sistema de trazabilidad son: 1. En todas las etapas de la cadena debe asegurarse la sanidad de los alimentos; 2. Las empresas agroalimentarias deben poder identificar a cualquier sujeto de la cadena; 3. Las empresas deben establecer procedimientos y métodos necesarios para ello; 4. Deben ponerse en práctica sistemas y procedimientos para poder identificar los productos entregados; 5. Los alimentos comercializados deben ser identificados para efectos de determinar su procedencia. Es evidente la necesidad de encontrar un equilibrio entre los mecanismos de protección de la seguridad alimentaria con fines preventivos -principio de precaución-, y la garantía de la libre circulación de productos agroalimentarios que cumplan con estándares científicos internacionales. Lo anterior produce como exigencia el “seguimiento” de los productos agrícolas y alimentarios, es decir la trazabilidad en toda la cadena, a fin de determinar la eventual responsabilidad que pueda corresponder al productor agrario o a la empresa transformadora de los productos en alimentos, incluso en cada fase de la cadena.” Por otra parte, la Ley de Protección Fitosanitaria, No. 7664 del 8 de abril de 1997, también incorpora normas para evitar y prevenir la introducción y difusión de plagas que amenacen la seguirdad alimentaria y la actividad económica sustentada en la producción agrícola, evitando que dichas medidas constituyan innecesariamente un obstáculo al libre comercio (artículo 2). Por esa razón se establecen mecanismos de control de establecimiento, registro, e inscripción de insumos para uso agrícola, estableciendo incluso normas de responsabilidad agroambietnal cuando se produzcan daños y perjuicios a la agricultura al ambiente y a la salud humana y animal (Capítulo IV). Dentro de este contexto, adquiere particular relevancia para el ejercicio de la actividad productiva agraria la utilización de agroquímicos, tema sobre el cual existen múltiples regulaciones a nivel normativo nacional, regional e internacional (artículo 47). Porque precisamente su regulación es fundamental, dentro del marco de la competitividad agraria de los productores a escala global. En ese contexto se promulgan leyes nacionales que introducen, o al menos procuran hacerlo, sistemas integrados de control agroalimentario y agroambiental, para garantizar la seguridad de las personas, del medio ambiente, y de las plantas y de los animales, e incluso evitar la contaminación excesiva de los recursos hídricos. Sin duda, el uso racional de plaguicidas sintéticos con fines de uso agrícola, promueven la competitividad del sector agropecuario, y por ello es que el reglamento se inspira en la creación de un sistema de registro equilibrado y moderno. Es un claro ejemplo del esfuerzo por darle completes y organicidad, a una gran cantidad de normas dispersas en el ordenamiento jurídico, para responder a las exigencias de la normativa internacional especializada, tanto emanada de la Organización Mundial del Comercio, como de Organismos Especializados, de la FAO, y de la OMS, estrechamente vinculados con el Codex Alimentarius, y con las Convenciones Internacionales de Medio Ambiente. Por eso el Decreto es dictado conjuntamente por la Presidencia, y los Ministros de Agricultura, Salud, Ambiente y Energía y el de Economía, Industria y Comercio. Es evidente que el fenómeno vincula a todos el proceso productivo agropecuario, he incluso toda la faceta previa de producción, registro, control y fiscalización de los plaguicidas de uso en la cadena agroproductiva.

VII.- SOBRE LA REDUCCIÓN DE LOS RIESGOS PARA LA SALUD Y EL AMBIENTE, CONFORME A LO DISPUESTO EN EL ARTÍCULO 5 CÓDIGO INTERNACIONAL DE CONDUCTA PARA LA DISTRIBUCIÓN Y UTILIZACIÓN DE PLAGUICIDAS. Resulta de interés remitir a lo dispuesto en el citado Código Internacional de Conducta para la Distribución y Utilización de Plaguicidas, que fue adoptado, por primera vez en 1985, por la vigésima quinta sesión de la conferencia de la Organización de las Naciones Unidas para la Agricultura y la Alimentación (FAO). Según se explica en el prefacio de la versión revisada (adoptado por el 123º periodo de sesiones del Consejo de la FAO, noviembre 2002), dicho código de conducta fue adoptado y ha sido revisado con el propósito de conseguir una mayor seguridad alimentaria y, al mismo tiempo, proteger la salud humana y el medio ambiente. Para tales efectos se establecen estándares de conducta que han de servir como marco y punto de referencia para el uso adecuado y racional de los plaguicidas, que se centran en la reducción del riesgo, la protección de la salud humana y ambiental y el apoyo al desarrollo de la agricultura sostenible mediante el uso eficaz de los plaguicidas [fuente: (Fuente: http://www.fao.org/agriculture/crops/core-themes/theme/pests/pm/code/en/(05/08/11)] En tal contexto, dicho código de conducta establece, en su artículo 5, las siguientes obligaciones para los gobiernos y la industria de plaguicidas:

“Artículo 5. Reducción de los riesgos para la salud y el ambiente 5.1 Los gobiernos deberían:

5.1.1 implementar un sistema de registro y control de plaguicidas según lo indicado en el Artículo 6; 5.1.2 revisar periódicamente los plaguicidas que se comercializan en el propio país, sus usos aceptables y su disponibilidad para cada sector del público, y llevar a cabo revisiones especiales cuando la evidencia científica lo aconsejen; 5.1.3 llevar a cabo un programa de vigilancia de la salud de las personas expuestas a plaguicidas en su trabajo, e investigar y documentar los casos de envenenamiento; 5.1.4 dar orientaciones e instrucciones al personal de salud, médicos y el personal de hospitales para el tratamiento de casos sospechosos de envenenamiento por plaguicidas (25); 5.1.5 establecer en lugares estratégicos centros nacionales o regionales de información y control para casos de envenenamiento, a fin de que puedan dar orientaciones inmediatas sobre primeros auxilios y tratamiento médico, y resulten accesibles en todo momento (25); 5.1.6 utilizar todos los medios posibles para recoger datos fiables y mantener estadísticas sobre los aspectos sanitarios de los plaguicidas y los incidentes de envenenamiento por plaguicidas, con objeto de establecer el sistema armonizado de la OMS para la identificación y el registro de esos datos (25). Deberían disponer de personal debidamente entrenado y de recursos suficientes para asegurar que se recoja una información exacta; 5.1.7 proporcionar a los servicios de extensión y asesoramiento, así como a las organizaciones de agricultores, información adecuada sobre estrategias y métodos prácticos de MIP y sobre la variedad de productos plaguicidas disponibles para su uso; 5.1.8 asegurar, con la cooperación de la industria de plaguicidas, que, en los casos en que los que se distribuyan plaguicidas por los mismos canales en los que se distribuyen alimentos, ropa, medicinas y otros productos para consumo o aplicación tópica, tales plaguicidas estén físicamente separados de otras mercancías para prevenir la contaminación y/o confusión de identidad. Además, cuando sea apropiado, deberán estar claramente señalados como materiales peligrosos. Hay que hacer todo lo posible por difundir información sobre los peligros que derivan de almacenar juntamente alimentos y plaguicidas (26); 5.1.9 utilizar todos los medios posibles para recoger datos fiables, mantener estadísticas sobre la contaminación ambiental y notificar los incidentes específicos relacionados con plaguicidas; 5.1.10 implementar un programa de vigilancia de los residuos de plaguicidas presentes en los alimentos y en el ambiente.

5.2 Aun en los casos en que funcione un programa de control, la industria de plaguicidas debería:

5.2.1 cooperar en la reevaluación periódica de los plaguicidas que se comercializan; <![if ¡supportLists]>2. <![endif]> proveer a los centros que se ocupan del tratamiento de envenenamiento por plaguicidas, y a su personal médico, de información sobre los peligros relacionados con los plaguicidas y sobre el tratamiento adecuado; 5.2.3 hacer todos los esfuerzos razonables para reducir los riesgos que entrañan los plaguicidas:

5.2.3.1 poniendo a disposición fórmulas menos tóxicas; 5.2.3.2 presentando los productos en envases listos para su uso; 5.2.3.3 desarrollando métodos y equipos de aplicación que reduzcan al mínimo la exposición a los plaguicidas; 5.2.3.4 utilizando envases retornables y rellenables cuando existan sistemas eficaces de recolección de envases; 5.2.3.5 utilizando envases que no sean atractivos o fáciles de reutilizar y promoviendo programas que desalienten su reutilización, cuando no existan sistemas eficaces para su recolección; 5.2.3.6 utilizando envases que no sean atractivos o fácilmente abiertos por los niños, particularmente cuando se trate de productos de uso doméstico; 5.2.3.7 empleando un etiquetado claro y conciso; <![if ¡supportLists]>4. <![endif]>interrumpir la venta y retirar los productos cuando su manipulación o utilización entrañe un riesgo inaceptable bajo cualquiera de sus indicaciones de uso o restricciones.

5.3 Los gobiernos y la industria deberían cooperar además en la reducción de los riesgos:

5.3.1 promoviendo el uso de equipo de protección personal apropiado y de costo accesible (5); 5.3.2 estableciendo disposiciones para almacenar los plaguicidas de forma segura tanto en los almacenes como en las explotaciones agrícolas (26, 27); 5.3.3 estableciendo servicios para la recolección y la disposición segura de los envases usados y las pequeñas cantidades de plaguicidas que no se han usado (28); 5.3.4 protegiendo la biodiversidad y reduciendo al mínimo los efectos adversos de los plaguicidas en el ambiente (agua, suelo y aire) y sobre organismos no objetivo.

5.4 Para evitar que se den casos de confusión y alarma injustificada entre el público, las partes interesadas deberían considerar todos los datos disponibles y promover una divulgación responsable de la información sobre los plaguicidas y sus usos.

5.5 Al crear instalaciones de producción en los países en desarrollo, los fabricantes y los gobiernos deberían cooperar para:

5.5.1 adoptar normas técnicas y seguir prácticas apropiadas a la naturaleza de las operaciones de fabricación y a los consiguientes peligros, y asegurar la disponibilidad de equipo de protección apropiado; 5.5.2 tomar todas las precauciones necesarias para proteger a los trabajadores, otras personas presentes, las comunidades circundantes y el ambiente; 5.5.3 asegurar la ubicación apropiada de las plantas de fabricación y formulación y un adecuado control de sus desechos y efluentes; 5.5.4 mantener procedimientos que garanticen la calidad, a fin de asegurar el cumplimiento de las normas pertinentes de pureza, rendimiento, estabilidad e inocuidad.” VIII.- SOBRE LA REGULACIÓN EN MATERIA DE REGISTRO DE LOS PLAGUICIDAS. El uso adecuado de los plaguicidas puede resultar útil para el control y eliminación de las plagas, en beneficio de la seguridad alimentaria de la población y de la actividad económica sustentada en la producción agrícola. Sin embargo, debe reconocerse el riesgo potencial que puede implicar para la salud humana y el ambiente el uso de tales sustancias. Lo que incluso ha motivado la adopción de instrumentos internacionales con el objetivo expreso de proteger la salud humana -incluida la salud de los consumidores y de los trabajadores- y el medio ambiente frente a los posibles efectos perjudiciales de los plaguicidas, como es el caso del Convenio de Rotterdam para la Aplicación del Procedimiento de Consentimiento Fundamentado Previo a Ciertos Plaguicidas y Productos Químicos Peligrosos Objeto del Comercio Internacional, que fue aprobado por Costa Rica, por medio de Ley No. 8705 del 13 de febrero del 2009. En cuyo caso, ante la consulta legislativa preceptiva de constitucionalidad planteada ante este Tribunal (expediente número 08-015252-0007-CO), de previo a la aprobación de dicho instrumento internacional, este Tribunal señaló- en lo que interesa- que:

“(…) el Estado costarricense está en el deber de actuar en forma eficaz y anticipada, para evitar la ocurrencia de eventos que degraden el medio ambiente y comprometan su sostenibilidad. Desde esa perspectiva, que se comprometa, a través de un tratado internacional como el consultado, o mediante un acto interno, a facilitar la utilización racional de los productos químicamente peligrosos objeto de comercio internacional, no solamente es posible, sino totalmente acorde con sus deberes constitucionales. Los plaguicidas y los productos químicos industriales son sustancias que pueden causar daños a la salud humana y en el ambiente. Ante tal amenaza, el Convenio de Rotterdam proporciona a las Partes la posibilidad de conocer de antemano la composición y los efectos de algunos productos químicos, los cuales son expresamente señalados en su Anexo III. Las medidas idóneas que el Estado tome para regular la comercialización y el empleo de dichos productos en actividades industriales, agrícolas, etc. Resultan conformes con su deber de preservar los mencionados valores de rango constitucional. De ahí que los deberes que asumiría el Estado en caso de aprobar definitivamente este Convenio resultan legítimos, conforme al Derecho de la Constitución. Se estaría ante una decisión soberana del Estado de someterse a las obligaciones contenidas en el Convenio, para contribuir a la protección de la salud de las personas y la integridad del medio ambiente, por lo que se puede concluir que, en términos generales, de las cláusulas del Convenio de Rotterdam, cuya aprobación es sometido a consulta, no se observan vicios de inconstitucionalidad.” (resolución número 2008-018207 de las 18:15 horas del 10 de diciembre del 2008) Con lo que se verifica que este Tribunal ha reconocido el riesgo que puede entrañar el uso de los plaguicidas y la trascendencia de adoptar medidas idóneas para regular su empleo. En el ordenamiento jurídico costarricense existe diversa normativa legal y reglamentaria de la que se deriva que la actividad de importación, fabricación, comercialización y empleo de los plaguicidas está fuertemente sometida a la potestad de policía del Estado, en aras de garantizar el derecho a la salud y al medio ambiente sano y ecológicamente equilibrado. Se puede citar, en primer lugar, la Ley General de Salud, que en su artículo 213 dispone:

“ARTICULO 213.- Toda persona, natural o jurídica, que se ocupe en producir alimentos, deberá hacerlo en condiciones ambientales sanitarias y empleando técnicas de defensa o conservación aprobadas por la autoridad de salud, a fin de evitar, principalmente, la contaminación de tales productos y su peligrosidad debida a la presencia de residuos tóxicos proveniente de su tratamiento con plaguicidas u otros sistemas de defensa o conservación.” Mientras que en el artículo 244 de ese mismo cuerpo normativo se establece:

“ARTICULO 244.- Las personas naturales y jurídicas que importen, fabriquen, manipulen, almacenen, transporten, comercien, suministren o apliquen sustancias, mezclas de sustancias o productos denominados plaguicidas por la ley de sanidad vegetal, quedarán sujetas a las disposiciones reglamentarias que el Ministerio dicte de común acuerdo con el Ministerio de Agricultura para el resguardo de la salud de las personas de conformidad con esa ley, los interesados deberán registrar todo pesticida o producto destinado al control o exterminio de las infestaciones y solicitar permiso previo para operar cuando tales sustancias, mezclas de sustancias o productos que por su naturaleza o uso no queden incluidos en la ley mencionada fueren capaces de algún modo de producir intoxicaciones o daños serios a la salud de las personas o de los animales útiles o inofensivos al hombre.” Por su parte, mediante la Ley de Protección Fitosanitaria (Ley No. 7664 de 8 de abril de 1997) se declaró de interés público y aplicación obligatoria, las medidas de protección fitosanitaria establecidas en esa ley y sus reglamentos (art. 1). Además, dentro de los objetivos de dicha ley se incluye: “Regular el uso y manejo de sustancias químicas, biológicas o afines y equipos para aplicarlas en la agricultura; asimismo, su registro, importación, calidad y residuos, procurando al mismo tiempo proteger la salud humana y el ambiente” (artículo 2, inc. E). La autoridad competente en la materia es el Servicio Fitosanitario del Estado, al que le corresponde –entre otras funciones-: “Controlar las sustancias químicas, biológicas o afines para uso agrícola, en lo que compete a su inscripción, importación, exportación, calidad, tolerancia, residuos, dosificaciones, efectividad, toxicidad, presentación al público, conservación, manejo, comercio, condiciones generales de uso, seguridad y precauciones en el transporte, almacenamiento, eliminación de envases y residuos de tales sustancias; asimismo, controlar los equipos necesarios para aplicarlas y cualquier otra actividad inherente a esta materia” (artículo 5, inc. O). En concordancia con lo anterior, los artículos 23, 24, 25 y 30 de dicho cuerpo normativo disponen:

“ARTICULO 23.- Inscripción de sustancias y equipos.

Según los requisitos que se señalarán en el reglamento de esta ley, todas las sustancias químicas, biológicas o afines y los equipos de aplicación para uso agrícola, deberán inscribirse en el registro que el Servicio Fitosanitario del Estado creará para disponer de información sobre las características de estos y velar por su correcta utilización en el país.” “ARTICULO 24.- Registro de sustancias.

Ninguna persona física o jurídica podrá importar, exportar, fabricar, formular, almacenar, distribuir, transportar, reempacar, reenvasar, anunciar, manipular, mezclar, vender ni emplear sustancias químicas, biológicas o afines para uso agrícola, que no estén registradas conforme a la presente ley.

Se exceptúan del registro indicado, las sustancias químicas, biológicas o afines para uso agrícola, que ingresen en tránsito, para la investigación o el combate de problemas fitosanitarios específicos. En estos casos, el permiso solo se otorgará en forma temporal por razones de urgencia, técnicamente justificadas ante el Servicio Fitosanitario del Estado.

El Servicio denegará la autorización cuando técnicamente no proceda y se lo notificará al interesado.” “ARTICULO 25.- Inscripción de personas.

Toda persona física o jurídica que registre, importe, exporte, reempaque y reenvase sustancias químicas, biológicas o afines y equipos de aplicación para uso agrícola deberá inscribirse en el registro que llevará el Servicio Fitosanitario del Estado, previo cumplimiento de los requisitos señalados en el respectivo reglamento.

El Servicio podrá denegar, suspender o cancelar el registro de sustancias químicas, biológicas o afines y de equipos de aplicación para uso agrícola, mediante resolución técnica fundada que se ajustará al debido proceso, conforme al reglamento respectivo.” “ARTICULO 30.- Prohibiciones y restricciones por razones técnicas.

El Ministerio de Agricultura y Ganadería podrá restringir o prohibir la importación, el tránsito, el redestino, la fabricación, la formulación, el reenvase, el reempaque, el almacenamiento, la venta, la mezcla y la utilización de sustancias químicas, biológicas o afines y equipos de aplicación para uso agrícola, cuando se justifique por razones técnicas y se considere que emplearlas es perjudicial para la agricultura, la salud o el ambiente”.

Finalmente, la Ley para la Importación y Control de la Calidad de Agroquímicos (Ley No. 7017 del 17 de diciembre de 1985) señala, en su artículo 5, que:

“ARTICULO 5.- Con el propósito de asegurar la calidad y el uso de los agroquímicos, el Ministerio de Agricultura y Ganadería está obligado a efectuar controles periódicos sobre la calidad de estos productos en las fábricas y casas distribuidoras, en las que tomar las muestras necesarias para remitirlas al laboratorio de control de calidad Este Ministerio también tendrá a su cargo el control de la toxicidad crónica y de su efecto en la salud de las personas y del ambiente. No se podrá registrar ningún producto sin que se hayan practicado estos análisis. El Ministerio de Agricultura y Ganadería podrá prohibir la Circulación u ordenar la destrucción de los productos que no cumplan con las normas de calidad, as¡ como tomar otras medidas tendentes a mejorar la calidad de los agroquímicos. En lo que se refiere a la elaboración y control de las normas de calidad, el citado Ministerio actuar en coordinación con la Oficina Nacional de Normas y Unidades de Medidas del Ministerio de Economía y Comercio.” Se desprende de la normativa previamente citada que, como manifestación del referido poder de policía, se incluye el necesario registro de plaguicidas de previo a autorizar su importación, fabricación, comercialización o empleo, a fin de poder ejercer un control previo en cuanto al debido cumplimiento de los correspondientes requerimientos técnicos de calidad y seguridad, en protección de la salud pública y el medio ambiente.” De todo lo cual se extraen las siguientes ideas principales que sirven de base para esta nota:

*El derecho a la alimentación como un derecho humano impone la seguridad alimentaria y con ello exige la trazabilidad o rastreabilidad del producto durante toda la cadena alimentaria («de la granja a la mesa»). Por esa razón se establecen mecanismos de control de establecimiento, registro, e inscripción de insumos para uso agrícola, estableciendo incluso normas de responsabilidad agroambiental cuando se produzcan daños y perjuicios a la agricultura al ambiente y a la salud humana y animal.

*Los sistemas integrados de control agroalimentario y agroambiental, se establecen entonces para garantizar la seguridad de las personas, del medio ambiente, y de las plantas y de los animales, e incluso evitar la contaminación excesiva de los recursos hídricos.

*Según el Código Internacional de Conducta para la Distribución y Utilización de Plaguicidas, que fue adoptado por primera vez en 1985, por la vigésima quinta sesión de la conferencia de la Organización de las Naciones Unidas para la Agricultura y la Alimentación (FAO), se establecen estándares de conducta que han de servir como marco y punto de referencia para el uso adecuado y racional de los plaguicidas, que se centran en la reducción del riesgo, la protección de la salud humana y ambiental y el apoyo al desarrollo de la agricultura sostenible mediante el uso eficaz de los plaguicidas. Además, véase el Convenio de Rotterdam para la Aplicación del Procedimiento de Consentimiento Fundamentado Previo a Ciertos Plaguicidas y Productos Químicos Peligrosos Objeto del Comercio Internacional, que fue aprobado por Costa Rica, por medio de Ley No. 8705 del 13 de febrero del 2009.

*El uso de los plaguicidas, si bien puede resultar útil para el control y eliminación de las plagas, en beneficio de la seguridad alimentaria de la población y de la actividad económica sustentada en la producción agrícola. También, debe reconocerse el riesgo potencial que puede implicar para la salud humana y el ambiente el uso de tales sustancias. Por ello, como manifestación del poder de policía del Estado, se incluye el necesario registro de plaguicidas de previo a autorizar su importación, fabricación, comercialización o empleo, a fin de poder ejercer un control previo en cuanto al debido cumplimiento de los correspondientes requerimientos técnicos de calidad y seguridad, en protección de la salud pública y el medio ambiente.

Además, se debe recordar la jurisprudencia constitucional sobre el principio de progresividad y el principio de no regresión en materia ambiental.- El principio de progresividad impone al Estado la obligación de ir aumentando, en la medida de sus posibilidades y desarrollo, el nivel de protección del derecho al ambiente. Es la obligación de ir elaborando y ejecutando políticas y normas tendientes a lograr progresivamente la plena efectividad del derecho al ambiente. El principio de no regresión se erige como una garantía sustantiva del derecho a un ambiente sano y ecológicamente equilibrado, en virtud del cual el Estado se ve obligado a no adoptar medidas, políticas, ni aprobar normas jurídicas que empeoren la situación de los derechos alcanzada hasta entonces (ver voto 2016-00415). En este caso, se constata que el decreto derogado por el decreto en cuestión era mucho más adecuado, completo y riguroso para el ingreso y control de plaguicidas. Lo cual constata la regresividad en esta materia. Comparando la regulación que hace el decreto impugnado con la regulación anterior, se evidencia la regresividad y con ello además, la no progresividad en la tutela de la salud y el ambiente en materia de regulación en el registro y uso de plaguicidas en nuestro país.

Grave peligro para el ambiente y la salud pública: Resulta alarmante la gran preocupación que se ha expresado por la calidad de plaguicidas que podrían llegar a liberarse en los campos agrícolas y el ambiente, puesto que, primero, los IAGT se registran por equivalencia o se revalidan, sin la información técnica necesaria para una evaluación de los riesgos a la salud y ambiente, lo cual contraviene las recomendaciones de la OCDE (que establece la necesidad de realizar evaluación de riesgo, previo al registro de sustancias químicas, como con los plaguicidas); y segundo, al no requerir la presentación de pruebas biológicas, para el registro de productos formulados que contienen los IAGT no evaluados, se colige un desconocimiento de los efectos en el ser humano y el ambiente, como también una incertidumbre de si el producto cumple su función de control de plagas.

Trascendencia del tema en cuestión para la salud humana: Debe recordarse la trascendencia del tema tratado en cuestión, pues los plaguicidas tienen una injerencia directa en la salud humana. Las sustancias agroquímicas y biológicas que se utilizan en la agricultura pueden representar un daño –o riesgo de vulneración-. Estos agroquímicos llegan directamente a los alimentos cultivados, y luego, a las mesas de todos los consumidores. De forma tal que, los insumos agrícolas, particularmente los plaguicidas, son susceptibles de provocar daños irreparables en el ambiente y la salud, sobre todo si se usan de manera incorrecta, por lo que el Estado debe dictar las normas y adoptar las medidas necesarias para que toda actividad relacionada con los productos agroquímicos, particularmente los plaguicidas, sea conforme con el deber de preservar la salud y el ambiente. Tal como lo menciona la accionante, el Consejo de Derechos Humanos de la Asamblea General de Naciones Unidas, mediante resolución 34/12 (A/HRC/RES/34/12), indicó sobre el derecho a la alimentación, aprobado el 23 de marzo de 2017, en su punto 41, “Invita a los Estados a promover prácticas que reduzcan al mínimo los posibles riesgos para la salud y el medio ambiente relacionados con los plaguicidas, garantizando al mismo tiempo su uso eficaz”. Además, el artículo 5 “Reducción de los riesgos para la salud y el medio ambiente” del Código Internacional de Conducta para la Gestión de Plaguicidas, de la FAO y la OMS, establece que los gobiernos deberían implementar una política y un sistema de registro y control de plaguicidas de conformidad con el artículo 6, que transcriben, que señala políticas y legislación, establecer sistemas e infraestructuras para que cada producto plaguicida sea registrado antes de estar disponible, evaluaciones de riesgos y adoptar decisiones de gestión de riesgos, y aplicar los principios descritos en el Manual sobre el desarrollo y empleo de las especificaciones de la FAO y de la OMS para productos fitosanitarios, a efectos de determinar la equivalencia entre plaguicidas.

Violación al principio preventivo, principio precautorio, principio pro natura y principio de objetivación de la tutela ambiental: La normativa impugnada es contraria a lo que mandan los principios constitucionales en materia ambiental: principio preventivo (cuando haya certeza de posibles daños al ambiente, la actividad afectante deba ser prohibida, limitada, o condicionada al cumplimiento de ciertos requerimientos. En general, este principio aplica cuando existen riesgos claramente definidos e identificados al menos como probables; asimismo, tal principio resulta útil cuando no existen informes técnicos o permisos administrativos que garanticen la sostenibilidad de una actividad, pero hay elementos suficientes para prever eventuales impactos negativos), principio precautorio (cuando haya peligro de daño grave e irreversible, la falta de certeza científica absoluta no deberá utilizarse como razón para postergar la adopción de medidas eficaces en función de los costos para impedir la degradación del medio ambiente. El principio parte de una incertidumbre científica razonable en conjunto con la amenaza de un daño ambiental grave e irreversible), principio pro natura (en caso de duda o incerteza las controversias deben resolverse y las normas deben interpretarse a favor de la protección y conservación del ambiente) y el principio de objetivación de la tutela ambiental (o principio de la vinculación a la ciencia y a la técnica, según el cual se impone acreditar con estudios técnicos la toma de decisiones en esta materia, tanto en relación con actos como de las disposiciones de carácter general -tanto legales como reglamentarias-, de donde se deriva la exigencia de la “vinculación a la ciencia y a la técnica”, con lo cual, se condiciona la discrecionalidad de la Administración en esta materia. Ha sido definido como principio número 17 de la Declaración de Río sobre el Medio Ambiente). Cuando se está ante una situación que exige la aplicación del principio precautorio, los entes y órganos públicos deben abstenerse de autorizar, aprobar o permitir toda solicitud nueva o de modificación que razonablemente implique un riesgo grave, incluso se encuentran obligados a suspender las actividades que se encontrasen en curso, asimismo en paralelo tienen que adoptar con eficiencia todas las medidas requeridas para la preservación de un ambiente sano y ecológicamente equilibrado. Por ende, la aplicación del principio precautorio implica que cuando existan indicadores de que cierta actividad plausiblemente podría ocasionar daños graves e irreversibles al ambiente, la falta de certeza o evidencia científica absoluta al respecto no exime de la obligación de adoptar todas aquellas medidas eficientes y eficaces para impedir una vulneración al ambiente. Además, en atención a la teoría de la Drittwirkung der Grundrechte, tal principio extiende su función orientadora a las conductas de sujetos de derecho tanto público como privado.

Lo anterior es violado por el decreto en cuestión. Así, para resaltar aún más la importancia de la protección del derecho al ambiente, a la salud y a la seguridad alimentaria, y en aplicación de los principios constitucionales ambientales de progresividad y no regresión, principio precautorio, principio preventivo, principio in dubio pro natura, y principio de objetivación, he considerado consignar esta nota en los términos expresados.

Fernando Cruz Castro 1