Technical Regulation on Maximum Residue Limits of Pesticides in VegetablesReglamento Técnico de Límites Máximos de Residuos de Plaguicidas en Vegetales

throughout the entire text - Complete Text of Standard 35301 RTCR 424-2008. Technical Regulation on Maximum Residue Limits of Pesticides in Vegetables Complete Text of Act: C6F6A Nº 35301-MAG-MEIC-S Nº 35301-MAG-MEIC-S THE PRESIDENT OF THE REPUBLIC AND THE MINISTERS OF AGRICULTURE AND LIVESTOCK, OF ECONOMY, INDUSTRY AND COMMERCE AND THE MINISTER OF HEALTH In the use of the powers conferred upon them by Article 140, subsections 3) and 18) and Article 146 of the Political Constitution and in accordance with the provisions of Articles 28 and 29 of the General Law of Public Administration, Law Nº 6227 of May 2, 1978 and in conformity with Articles 1, 4, and 5 of the Phytosanitary Protection Law, Law Nº 7664 of April 8, 1997 and its regulation; the Law for the Promotion of Agricultural Production and its amendments, Law Nº 7064 of April 29, 1987; Articles 30, 32, 35 subsection d), 48 subsection ch), 51 subsections a) and d), following and concordant; the Organic Law of the Ministry of Economy, Industry and Commerce, Law Nº 6054 of June 14, 1977 in relation to the Law of the National System for Quality and its amendments, Law Nº 8279 of May 2, 2002, Articles 1, 2, 3, 8, 9, 19, 20, 21, 31, 32, 33, 34, 39, 40, 41, 42, 43, following and concordant; the General Health Law, Law Nº 5395 of October 30, 1973, and the Organic Law of the Ministry of Health, Law Nº 5412 of November 8, 1973.

1. 1That it is a fundamental right of the inhabitants to enjoy a healthy and ecologically balanced environment, as well as an unavoidable duty of the State to ensure it.
2. 2That it is the duty of the State to stimulate and improve agricultural production and its management processes, ensuring that pesticides for agricultural use are utilized in accordance with the manufacturer's or formulator's information and according to the registration approved by the State Phytosanitary Service (Servicio Fitosanitario del Estado), preventing harm to humans, animals, and the environment.
3. 3That it is a socioeconomic function of the State to protect the consumer regarding the health, safety, and quality of the food they acquire and consume (or ingest), as well as to ensure fair practices in the trade of food products.
4. 4That among the activities that the State must carry out is that of guaranteeing the population access to safe food (alimentos inocuos) that meets adequate sanitary conditions for human consumption.
5. 5That the country joined the Food and Agriculture Organization of the United Nations (FAO) on April 7, 1948, an organization that helps developing countries and countries in transition to modernize and improve their agricultural activities, in order to ensure good nutrition for all, to achieve food security for all, and to ensure that people have regular access to good quality food that allows them to lead an active and healthy life. This organization also represents a very important international source of knowledge and information.
6. 6That the Codex Alimentarius Commission was created in 1963 by the FAO and the WHO to develop food standards and other related texts such as codes of good practice under the Joint FAO/WHO Food Standards Programme. Its main subjects are the protection of consumer health, ensuring clear trade practices, and promoting the coordination of all food standards agreed upon by governmental and non-governmental organizations.
7. 7That the General Agreement on Tariffs and Trade (GATT) was the origin of the World Trade Organization (WTO), established in 1995 as a result of the Uruguay Round of Trade Negotiations. Where Costa Rica began the procedure for its accession in June 1987 and ratified it on October 25, 1990. And upon ratifying the Marrakesh Agreement on December 26, 1994, it became a founding Member of the WTO.
8. 8That the results of the Uruguay Round encompass a large number of agreements that widely surpassed the initial rules relating to trade in industrial products. In 1995, agricultural topics were included for the first time.
9. 9That the Agreement on the Application of Sanitary and Phytosanitary Measures ("SPS Agreement") of the WTO entered into force on January 1, 1995, and its fundamental objective is the application of regulations regarding health and safety to global trade. The Committee on Sanitary and Phytosanitary Measures of the WTO contemplates the participation of other International Organizations as consultants and reference guides, such as the IPPC, the OIE, and the CODEX ALIMENTARIUS.

10.-That as the United States of North America and the countries that make up the European Union are countries that are part of the FAO, the WTO, that participate in CODEX, that conduct technical studies in the field of pesticides, and being the main commercial partners of Costa Rica, the Maximum Residue Limits (MRLs) (Límites Máximos de Residuos, LMR) established by entities or bodies of those regions are adopted in the second instance.

11.-That at present there are a series of molecules that are already in disuse or prohibited, there are other new molecules and others that, although they have existed for a long time, have had the level of permitted tolerances increased or decreased in vegetables and food, because over time there has been a variation in the daily intake of said vegetables or food, for which reason it is necessary to update Decreto Ejecutivo Nº 27630-MAG-MEIC-S of May nineteen, nineteen ninety-eight, RTCR-229:1996. Límites Máximos de Residuos de Plaguicidas en Vegetales, to adjust it to the current intake conditions and the demands of international trade of products for human consumption. Por tanto,

**RTCR 424-2008. Technical Regulation on Maximum Residue Limits of Pesticides in Vegetables (Reglamento Técnico de Límites Máximos de Residuos de Plaguicidas en Vegetales)** **Article 1**—To approve the following technical regulation: RTCR 424-2008. Technical Regulation on Maximum Residue Limits of Pesticides in Vegetables (Reglamento Técnico de Límites Máximos de Residuos de Plaguicidas en Vegetales).

**1. Objective and scope of application.** This technical regulation regulates matters relating to the maximum residue limits (MRLs) of pesticides and their metabolites, which are permitted in different vegetable crops, for human and animal consumption, at the national level.

**2. References.** - CODEX ALIMENTARIUS Standard Residues of pesticides in food; http://www.codexalimentarius.net/mrls/pestdes/jsp/pest_q-s.jsp. of April 9, 2008. Consulted August 11, 2008.

- EPA MRL Standard; http://www.epa.gov/pesticides/food/viewtols.htm. 2005 CFR-Title 20 volume 23. Consulted August 11, 2008.

- Regulation of the European Parliament and of the Council, of February 23, 2005, relating to maximum residue limits of pesticides in food and feed of plant and animal origin of the EU, in force at the time of importation. http://europa.eu/scadplus/leg/es/lvb/l21289.htm. Consulted August 11, 2008.

**3. Definitions.** For the purposes of this technical regulation, the following shall be understood as:

3.1. **Codex Alimentarius:** The Codex Alimentarius is a collection of international food standards that have been adopted by the Codex Alimentarius Commission (CAC). Codex provisions refer to the hygiene and nutritional quality of food, including microbiological standards, food additives, pesticide and veterinary drug residues, contaminants, labeling and presentation, and methods of sampling and risk analysis.

3.2. **Active ingredient (Ingrediente activo):** The component of a formulation responsible for the direct or indirect biological activity against pests and diseases, or for regulating plant metabolism/growth. A single formulated synthetic pesticide may be composed of one or more chemical or biological entities that may differ in relative activity. A formulation may contain one or more active ingredients.

3.3 **Maximum residue limit (MRL) (Límite máximo para residuos, LMR):** It is the maximum concentration of a pesticide residue (expressed in mg/kg) legally permitted on the surface or internal part of food products for human consumption and feed.

3.4 **Pre-harvest interval (Período de Carencia):** The legally established time, usually expressed in number of days, that must elapse between the last application of a pesticide and the harvest or grazing of animals. In the case of post-harvest applications, it refers to the interval between the last application and the consumption of the vegetable product.

3.5 **Pesticide (Plaguicida):** Any substance or mixture of substances intended to prevent, destroy, or control any pest, including vectors of human or animal diseases, undesirable species of plants or animals that cause harm or otherwise interfere with the production, processing, storage, transport, or marketing of food, agricultural commodities, wood and wood products, or animal feed, or which may be administered to animals to combat insects, arachnids, or other pests on or in their bodies. The term includes substances intended for use as plant growth regulators, defoliants, desiccants, fruit thinning agents, or agents to prevent premature fruit drop, and substances applied to crops before or after harvest to protect the commodity against deterioration during storage and transport.

3.6 **Pesticide residue (Residuo de plaguicida):** Any specified substance present in food for human consumption, agricultural commodities, or animal feed as a consequence of the application of a pesticide. The term includes any derivative of a pesticide such as conversion products, metabolites, and reaction products, and impurities considered of toxicological importance.

**4. Abbreviations.** For the purposes of this Regulation, the following shall be understood as:

4.1 **EPA:** Environmental Protection Agency (for its acronym in English), the environmental protection agency of the United States of North America.

4.2 **EEUU:** United States of North America.

4.3 **FAO:** Food and Agriculture Organization of the United Nations (for its acronym in English).

4.4 **MRLs (LMR):** Maximum Residue Limits (Límites Máximos de Residuos).

4.5 **MAG:** Ministry of Agriculture and Livestock (Ministerio de Agricultura y Ganadería).

4.6 **MEIC:** Ministry of Economy, Industry and Commerce (Ministerio de Economía, Industria y Comercio).

4.7 **MS:** Ministry of Health (Ministerio de Salud).

4.8 **SFE:** State Phytosanitary Service (Servicio Fitosanitario del Estado).

4.9. **EU (UE):** European Union.

**5. Specifications.** 5.1. **Maximum Residue Limits to apply in the first instance.** The MRLs established by the Codex Alimentarius are hereby adopted as official, which shall be applied in the first instance.

5.2. **Maximum Residue Limits to apply in the second instance.** In cases where no MRLs established by the Codex Alimentarius exist, the MRLs established by the EPA and the EU shall apply. When the MRLs established by the EPA and the EU are different, the one with the highest nominal value shall be adopted, all in accordance with Article 5 subsections 1, 3, and 4 of the World Trade Organization Agreement on the Application of Sanitary and Phytosanitary Measures.

Notwithstanding the foregoing, the MRLs of other countries may be adopted as official once the SFE Registration Unit verifies that the procedure for establishing them is similar to those used by the Codex Alimentarius. These MRLs shall be defined by administrative resolution, issued by the Directorate of the SFE, which shall be published in the Official Gazette La Gaceta and placed on the SFE's Web page.

5.3 **Change of pre-harvest intervals (períodos de carencia):** If as a consequence of this decree, and each time modifications of such limits are presented by the reference entities, the MRLs change and this in turn modifies the pre-harvest interval (periodo de carencia) or some other agricultural practice, every registrant is obligated to declare said changes in the SFE Registry; these changes must be reflected in the pamphlet.

5.4 **Procedure and requirements for changing the pre-harvest intervals (períodos de carencia).** To change the pre-harvest intervals (períodos de carencia) of those registered products whose maximum residue limits (MRLs) have been modified within the scope of this Decree, the registrant must submit to the SFE the petition together with the technical information, resulting from field trial data that supports it and endorsed by a professional whose suitability is recognized and granted by the College of Agronomic Engineers (Colegio de Ingenieros Agrónomos), in addition to the label and pamphlet projects that support the change.

5.5 **Publication of the list of maximum residue limits (MRLs).** The MAG, through the State Phytosanitary Service (Servicio Fitosanitario del Estado), shall make available and known to the administered parties the list of permitted maximum residue limits (MRLs) via its Web page, which shall be updated annually, without prejudice that the SFE may make specific updates at any time, approved by the reference entities (CODEX, EPA, and EU) or that have been authorized by the SFE in accordance with the preceding subsections 5.1 and 5.2.

**6. Surveillance and verification.** This shall be carried out as established in the following decrees:

6.1. Decreto Ejecutivo Nº 27683 MAG-MEIC-S, called "Laboratorio para el análisis de residuos de sustancias químicas y biológicas de uso en la agricultura para consumo humano y animal", published on May 19, 1998.

6.2. Decreto Ejecutivo Nº 27056 MAG-MEIC, called "Toma de muestras para análisis de residuos de sustancias químicas y afines de uso agrícola en los cultivos de vegetales", published on January 5, 1998.

**7. Bibliography:** - Agreement on Sanitary and Phytosanitary Measures ("SPS Agreement") of the WTO, entered into force on January 1, 1995. General Phytosanitary Protection Law, N° 7674, published on April 8, 1997.

- Regulation Nº 33495-MAG-S-MINAE-MEIC, on Registration, Use, and Control of Formulated Synthetic Pesticides, Technical Grade Active Ingredient (Ingrediente Activo Grado Técnico), Adjuvants, and Related Substances for Agricultural Use, published January 10, 2007.

- CODEX ALIMENTARIUS Standard Residues of pesticides in food; http://www.codexalimentarius.net/mrls/pestdes/jsp/pest_q-s.jsp. of April 9, 2008. Consulted August 11, 2008.

- EPA MRL Standard; http://www.epa.gov/pesticides/food/viewtols.htm. 2005 CFR-Title 20 volume 23. Consulted August 11, 2008.

- Regulation of the European Parliament and of the Council, of February 23, 2005, relating to maximum residue limits of pesticides in food and feed of plant and animal origin of the EU, in force at the time of importation. http://europa.eu/scadplus/leg/es/lvb/l21289.htm. Consulted August 11, 2008.

- www.codexalimentarius.net/ Consulted August 11, 2008.

**Article 2**—Sanctions for noncompliance. Any registrant who fails to comply with the provisions of this executive decree shall be sanctioned in accordance with the provisions of the Phytosanitary Protection Law (Ley de Protección Fitosanitaria), as applicable. The foregoing is without prejudice to pertinent criminal or civil actions.

**Article 3**—Derogation. Decreto Ejecutivo 27630 MAG-MEIC-S of May nineteen, nineteen ninety-eight, RTCR-229:1996 "Límites Máximos de Residuos de Plaguicidas en Vegetales" is hereby repealed.

**First transitory provision.**—All holders of registrations for pesticides for agricultural use, whose MRLs vary due to the publication of this decree, and if the modification requires changes in the pre-harvest interval (periodo de carencia) or other agricultural practices, shall have a period of twelve months counted from the day following its publication, to declare the corresponding changes in the Registry and pamphlets, in accordance with what is indicated in sections 5.3 and 5.4 of subsection 5, of Article 1, of this decree. The foregoing period shall also govern for the replacement of pamphlets that do not contain said updated information.

**Second transitory provision.**—The SFE shall make available to the public through its Web page, within a period of six months from the publication of this regulation, the list of MRLs indicated in subsection 5, section 5.4, of Article 1.

**Article 4**—It shall enter into force upon its publication in the Official Gazette La Gaceta.

Given at the Presidency of the Republic.—San José, on the twenty-eighth day of the month of April of the year two thousand nine.

Considering:

Decretan:

en la totalidad del texto - Texto Completo Norma 35301 RTCR 424-2008. Reglamento Técnico de Límites Máximos de Residuos de Plaguicidas en Vegetales Texto Completo acta: C6F6A Nº 35301-MAG-MEIC-S Nº 35301-MAG-MEIC-S EL PRESIDENTE DE LA REPÚBLICA Y LOS MINISTROS DE AGRICULTURA Y GANADERÍA, DE ECONOMÍA, INDUSTRIA Y COMERCIO Y LA MINISTRA DE SALUD En el uso de las potestades que les confiere el artículo 140, inciso 3) y 18) y artículo 146 de la Constitución Política y de acuerdo con lo dispuesto en los artículos 28 y 29 de la Ley General de la Administración Pública, Ley Nº 6227 de 2 de mayo de 1978 y de conformidad con los artículos 1, 4, y 5 de la Ley de Protección Fitosanitaria, Ley Nº 7664 de 8 de abril de 1997 y su reglamento; Ley de Fomento a la Producción Agropecuaria y sus reformas, Ley Nº 7064 del 29 de abril de 1987; artículos 30, 32, 35 inciso d), 48 inciso ch), 51 incisos a) y d), siguientes y concordantes; la Ley Orgánica del Ministerio de Economía, Industria y Comercio, Ley Nº 6054 de 14 de junio de 1977 en relación con la Ley del Sistema Nacional para la Calidad y sus reformas, Ley Nº 8279 del 2 de mayo de 2002, artículos 1, 2, 3, 8, 9, 19, 20, 21, 31, 32, 33, 34, 39, 40, 41, 42, 43, siguientes y concordantes; la Ley General de Salud, Ley Nº 5395 de 30 de octubre de 1973, y la Ley Orgánica del Ministerio de Salud, Ley Nº 5412 de 8 noviembre de 1973.

1. 1Que es un derecho fundamental de los habitantes gozar de un ambiente sano y ecológicamente equilibrado, así como un deber ineludible del Estado procurarlo.
2. 2Que es deber del Estado estimular y mejorar la producción agropecuaria y sus procesos de manejo, velando porque los plaguicidas de uso agrícola sean utilizados, conforme a la información del fabricante o formulador y según el registro aprobado por el Servicio Fitosanitario del Estado, previniendo daños al ser humano, a los animales y al ambiente.
3. 3Que es función socioeconómica del Estado proteger al consumidor en cuanto a la salud, seguridad y calidad de los alimentos que adquiere y consume (o ingiere), así como asegurar prácticas equitativas en el comercio de productos alimenticios.
4. 4Que dentro de las actividades que el Estado debe realizar, está la de garantizar a la población el acceso a alimentos inocuos que reúnan condiciones sanitarias adecuadas para el consumo humano.
5. 5Que el país ingresó el 7 de abril de 1948 a la Organización de las Naciones Unidas para la Agricultura y la Alimentación-FAO, organización que ayuda a los países en desarrollo y a los países en transición a modernizar y mejorar sus actividades agrícolas, con el fin de asegurar una buena nutrición para todos, a fin de alcanzar la seguridad alimentaria para todos, y asegurar que las personas tengan acceso regular a alimentos de buena calidad que les permitan llevar una vida activa y saludable. Esta organización representa también, una fuente internacional muy importante de conocimientos y de información.
6. 6Que la Comisión del Codex Alimentarius fue creada en 1963 por la FAO y la OMS para desarrollar normas alimentarias y otros textos relacionados tales como códigos de buenas prácticas bajo el Programa Conjunto FAO/OMS de Normas Alimentarias. Sus materias principales son la protección de la salud de los consumidores, asegurar unas prácticas de comercio claras y promocionar la coordinación de todas las normas alimentarias acordadas por las organizaciones gubernamentales y no gubernamentales.
7. 7Que el Acuerdo General de Aranceles Aduaneros y Comercio (GATT), fue el origen de la Organización Mundial de Comercio (OMC), establecida en 1995 como resultado de la Ronda Uruguay de Negociaciones Comerciales. Donde Costa Rica inició el procedimiento para su adhesión en junio de 1987 y ratificado el 25 de octubre de 1990. Y al ratificar el 26 de diciembre de 1994 el Acuerdo de Marrakech, se convirtió en Miembro fundador de la OMC.
8. 8Que los resultados de la Ronda Uruguay abarcan un gran número de acuerdos que superaron ampliamente las reglas iniciales relativas al comercio de productos industriales. En 1995 se incluyeron, por primera vez, temas de la agricultura.
9. 9Que el Acuerdo sobre la aplicación de las Medidas Sanitarias y Fitosanitarias ("Acuerdo MSF") de la OMC, entró en vigor el 1° de enero de 1995 y su objetivo fundamental es la aplicación de reglamentaciones en materia de sanidad e inocuidad al comercio global. El Comité de Medidas Sanitarias y Fitosanitarias de la OMC contempla la participación de otros Organismos Internacionales como consultores y guía de referencia, tales como la IPPC, la OIE y el CODEX ALIMENTARIUS.

10.-Que al ser los Estados Unidos de Norteamérica y los países que conforman la Unión Europea, países que forman parte de la FAO, de la OMC, que participan en CODEX, que realizan estudios técnicos en el campo de los plaguicidas, y al ser los principales socios comerciales de Costa Rica, se adoptan en segunda instancia, los Límites Máximos de Residuos-LMR, establecidos por entidades u organismos de esas regiones.

11.-Que en la actualidad existen una serie de moléculas que ya están en desuso o prohibidas, existen otras moléculas nuevas y otras que aunque existen desde hace mucho tiempo, han aumentado o disminuido el nivel de tolerancias permitido en los vegetales y en los alimentos, en razón de que con el tiempo ha existido una variación en la ingesta diaria de dichos vegetales o alimentos, por lo que se hace necesario actualizar el Decreto Ejecutivo Nº 27630-MAG-MEIC-S de diecinueve de mayo de mil novecientos noventa y ocho, RTCR-229:1996. Límites Máximos de Residuos de Plaguicidas en Vegetales, para ajustarlo a las condiciones actuales de ingesta y a las exigencias del comercio internacional de productos de consumo humano. Por tanto,

RTCR 424-2008. Reglamento Técnico de Límites Máximos de Residuos de Plaguicidas en Vegetales

Considerando:

Decretan: