Summary of Environmental Law in Mexico

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11 Chemical Substances and Products

 

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Summary

Chemical substances and products are governed by a number of overlapping laws and regulations and fall under the jurisdiction of six different regulatory agencies: (1) the Health Secretariat (Secretaría de Salud (SSA)); (2) the Secretariat of Agriculture, Livestock, Rural Development, Fisheries and Food (Secretaría de Agricultura, Ganadería, Desarrollo Rural, Pesca y Alimentación (SAGARPA)); (3) the Secretariat of the Environment and Natural Resources (Secretaría del Medio Ambiente y Recursos Naturales (SEMARNAT)); (4) the Secretariat of the Economy (Secretaría de Economía (SE)); and to a lesser extent (5) the Secretariat of Communications and Transport (Secretaría de Comunicaciones y Transportes (SCT)) and (6) the Secretariat of Labor and Social Welfare (Secretaría de Trabajo y Previsión Social (STPS)). As a consequence, the legal regime governing chemical substances remains one of the most complicated and often confusing subject matters of Mexican environmental law.

The two most important pieces of legislation governing chemical substances and products are the General Health Law (Ley General de Salud) and the Regulation under the General Health Law Regarding the Sanitary Control of Activities, Facilities, Products and Services (Reglamento de la Ley General de Salud en Materia de Control Sanitario de Actividades, Establecimientos, Productos y Servicios) (hereinafter Health Control Regulation). Together, the General Health Law and the Health Control Regulation spell out the definition of pesticides, fertilizers and toxic substances; establish a registration, licensing and permitting regime for pesticides, fertilizers and toxic substances; and provide for chemical substances labeling standards. SSA, in conjunction with other authorities, is charged under the General Health Law with establishing the Official Mexican Standards (Normas Oficiales Mexicanas (NOMs)) that apply to the use, application, development, labeling, storage, packaging, commercialization and distribution of all chemical substances. The General Health Law also provides that SSA shall oversee all permitting activities related to toxic substances and those pesticides and fertilizers that are not intended for commercial use in agricultural or forestry activities. In addition, other laws regulate chemical substances.

Ecology Law

The General Law of Ecological Balance and Environmental Protection (Ley General del Equilibrio Ecológico y la Protección al Ambiente) (hereinafter the Ecology Law) provides general standards pertaining to chemical substances, as part of its soil pollution prevention and control provisions. Generally speaking, the Ecology Law requires that the use of pesticides, fertilizers and toxic substances be compatible with the ecological balance of the soil ecosystem. On the other hand, the Ecology Law sets the bases for the cleaning and remediation of contaminated soils, so that they may be reused. Under the Ecology Law, SEMARNAT is granted authority, in conjunction with SE, SAGARPA and SSA, to develop environmental pollution prevention and control regulations and NOMs applying to chemical substances. In addition, Article 144 of the Ecology Law prohibits the import of pesticides, fertilizers and other hazardous substances whenever their use is banned in the country of origin.

Federal Animal Health Law

The Federal Animal Health Law (Ley Federal de Sanidad Animal) provides SAGARPA with the authority to issue NOMs relating to animal products and byproducts, including biological, chemical, pharmaceutical and feed products that are used or consumed by animals. The SAGARPA is also responsible for all registrations and authorizations of pesticides and fertilizers intended for agricultural and forestry use.

Federal Plant Health Law

The Federal Plant Health Law (Ley Federal de Sanidad Vegetal) grants SAGARPA authority to develop phytosanitary standards relating to the production, industrialization, movement or commercialization of vegetables, vegetable products or materials used in the production of vegetables, including fertilizers and pesticides.

Federal Consumer Protection Law

The Federal Consumer Protection Law (Ley Federal de Protección al Consumidor) provides general standards relating to the advertising, labeling, packaging, quality assurance, safety and warranty of chemical products and services intended for general consumption. These standards are administered and enforced by SE and the Federal Attorney General for Consumer Protection (Procuraduría Federal de Protección al Consumidor (PROFECO)).

Federal Labor Law and Work Safety Regulation

The Federal Labor Law (Ley Federal del Trabajo y Seguridad en el Trabajo) (hereinafter Labor Law) and the General Regulation Regarding Safety and Hygiene in the Workplace (Reglamento General de Seguridad e Higiene en el Trabajo) (hereinafter Work Safety Regulation) provide protection standards for individuals working in facilities where chemical substances are an integral part of the business operations or could pose occupational health risks. STPS, together with SSA, have jurisdiction over the enforcement of these worker protection standards.

Hazardous Waste Regulation Under Ecology Law

This Regulation was published in the Federal Official Gazette in 1988. It is administered by SEMARNAT and governs the generation, handling, importation and exportation of hazardous waste, as well as control and safety measures and sanctions.

Transportation of Chemical Substances

The Regulation for the Land Transport of Hazardous Materials and Wastes (Reglamento para el Transporte Terrestre de Materiales y Residuos Peligrosos) (hereinafter Waste Transportation Regulation) provides a separate legal regime governing the transport of hazardous materials and waste, including chemical substances. The administration and enforcement of the Waste Transportation Regulation falls under the jurisdiction of SCT. See Chapter 22, "Transportation", section 22.5.

Inter-Secretarial Coordinating Agency

Due to the number of laws and agencies that regulate chemical substances, an Inter-Secretarial Commission for the Control of the Processing and Use of Pesticides, Fertilizers and Toxic Substances (Comisión Intersecretarial para el Control del Proceso y Uso de Plaguicidas, Fertilizantes y Sustancias Tóxicas (CICLOPLAFEST)) was created in 1987. The agency's by-laws were published on 15 October 1988. CICOPLAFEST is presently composed of a Chairman and a Technical Committee with its respective Coordinator and five subcommittees. It is made up of representatives from SEMARNAT, SE, SAGARPA and SSA. In the period 1995-2000, it was deemed appropriate to invite participants from STPS and SCT.

CICOPLAFEST has the following responsibilities:

  1. administering a uniform procedure for all licensing, registration and permitting of any use, development, manufacture, distribution, storage, commercialization, export or import of chemical substances;
  2. establishing quantitative and qualitative integrated inventories of all chemical substances used in or imported into Mexico;
  3. participating in the development and issuance of NOMs for the regulation of chemical substances, which are consistent with public health and environmental protection standards;
  4. engaging in scientific and legal research on chemical substances in order to make scientific and legal recommendations related to the regulation, restriction or prohibition of such substances; and
  5. creating, through the regulatory powers of its four integrated Secretariats, Official Catalogs (Catálogos Oficiales) of those chemical substances that are registered and authorized in Mexico, including information pertaining to their main chemical characteristics, use and application procedures, associated risks, as well as any other safety data deemed necessary.

In addition, CICOPLAFEST is responsible for establishing an integrated system of official laboratories, training officials in the treatment of chemical wastes, revising tariff and duty codes for imported chemical substances and promoting administrative streamlining of procedures pertaining to chemical substances. The powers of CICOPLAFEST, however, are limited to submitting requests and recommending actions to the relevant Secretariats responsible for the regulation of a particular chemical substance.

CICOPLAFEST's actions are based on the provisions of the General Health Law, the Federal Plant Health Law and the Ecology Law.

State Committees on Pesticides, Fertilizers and Toxic Substances (Comités Estatales De Plaguicidas, Fertilizantes y Sustancias Tóxicas (COESPLAFEST)) have been created as CICOPLAFEST support agencies in the states. Their functions include: support in oversight activities; user orientation regarding import, export and registration procedures for pesticides, plant nutrients and toxic substances; creating state inventories of substances and establishments, as well as universities, institutes and public and private laboratories that support research; training; creation of a national registry of poisonings, by substances; and implementation of a state toxicology information system.

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11.1 New Substances: Pre-manufacture Stage

 

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Official Catalogs

Under Mexican regulations, chemical substances are grouped into three categories: (1) pesticides, (2) fertilizers and (3) toxic substances. In order for any chemical substance or product to be used, manufactured or distributed in Mexico, it must be first officially registered by CICOPLAFEST in the sanitary registry, an administrative action through which SSA authorizes the development, public sale, use and disposal of any product or equipment that contains toxic substances, pesticides or fertilizers. CICOPLAFEST is required to publish Official Catalogs of registered pesticides, fertilizers and toxic substances.

Between 1995 and 2000, five modifications were made to the Accord Establishing the Classification and Coding of Merchandise Subject to Regulation by CICOPLAFEST Agencies. These changes were intended to exclude substances the regulation of which was deemed unnecessary and to include new substances that met the applicable technical criteria. In the case of pesticides, the modifications also sought to include the common name to facilitate identification and to classify regulated products in generic and semigeneric classes. The current CICOPLAFEST accord was published on 26 August 1998, and was last amended on 13 June 2000.

As regards pesticides, there is an Official Pesticide Catalog containing the general product characteristics, the authorized plant use, and the pests to be controlled.

Pesticides

To register a pesticide, the requirements established by the SSA General Bureau of Environmental Health must be met. The main requirements to be filed are a CICOPLAFEST pesticide registration form; five copies of the health license or application; the quality control certificate from an authorized laboratory (for farm pesticides); and evidence of payment of the respective fee.

Fertilizers

To register fertilizers or plant nutrients, the following information must be submitted to CICOPLAFEST, as provided by the SSA General Bureau of Health: a duly filled out registration request; evidence of the payment of fees, as stipulated in the Federal Fees Law (Ley Federal de Derechos), on the form authorized by the Finance Secretariat (Secretaría de Hacienda y Crédito Público (SHCP); supplier letter issued within one year prior to beginning the procedure; fertilizer (or plant nutrient) safety data sheet in accordance with Official Mexican Standard NOM-114-STPS-1994, regarding risk identification and communication systems for chemical substances at the workplace, published in the Federal Official Gazette on 30 January 1996; in the case of imported fertilizers or plant nutrients, the original and four copies of the current certificate of registration and use in the country of origin, issued by the competent authority, as well as the original label from the country of origin; copies of the health license or application; and copies of the proposed labels in accordance with the applicable NOM.

Toxic Substances

Under the Chemical Substances Instruction (Instrucción de Substancias Químicas) published in the Federal Official Gazette on 12 December 1988, data on toxic substances, similar to that required for the registration of new pesticides, must be submitted to CICOPLAFEST. However, CICOPLAFEST has yet to create an Official Catalogue of registered toxic substances and there are currently no pre-manufacture review requirements for the use, manufacture or distribution of new toxic substances.

CICOPLAFEST does, nevertheless, engage in the limited checking of new toxic substances as part of the licensing requirements provided for under the Health Control Regulation and the Regulation Classifying Businesses and Risk Levels in Connection with Occupational Accidents and Health Insurance (Reglamento que Clasifica a las Empresas y los Niveles de Riesgo en Accidentes de Trabajo y Seguro por Enfermedad). Prior to the manufacturing a new chemical substance, a company must submit an application for risk classification to CICOPLAFEST, which will assign the company a "high," "medium" or "low" risk classification based on the assessment of the company's activities, including the use, manufacture or distribution of new toxic substances. If the activities of the company are categorized as "highly hazardous", a federal permit must be obtained from CICOPLAFEST for the use, manufacturing or distribution of the new substance. If the risk classification of the company is "medium" or "low", then the company must obtain the relevant permits from the state or local health agency. Under current policy, a new chemical will generally trigger a "high risk" classification until further information is available. However, no safety information is required for new chemical substances either at the state level or at the local level. A new environmental risk regulation is expected to be enacted soon.

Research and Development

All chemical substances used for research purposes are generally exempt from the permit and registration requirements. Pursuant to Article 7 of the Instruction Regarding Chemical Substances, this exemption applies to both new chemical substances and the ones already in existence.

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11.2 Manufacture, Import and Distribution

 

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Registration of Plant Nutrient Components

In order for any pesticide or fertilizer to be developed, produced, used or distributed, the product must first be registered in the Official Catalogs published by CICOPLAFEST in the Sanitary Registry. Chemicals remain registered until officially removed from the registry by CICOPLAFEST.

The following must be filed to register the above items:

  1. Fertilizer registration request.
  2. Proposed label with the following requirements: information on the hazards involved in handling the product; form of use; first aid; handling of full or empty containers; complete list of product ingredients in the order of quantity (i.e., listing ingredients from greatest to smallest quantities present); expression of quantities as a percentage, weight and using the International System of Measurements; not containing any confusing, exaggerated or deceptive information; not containing any such information as to the composition, origin and other product properties; and including the lot number and the dates of manufacture and expiration.
  3. In the case of imported products, the current certificate of registration and use or production authorization issued by the competent authority in the country of origin.
  4. Current supplier letter, in the case of importation.
  5. Evidence of the payment of fees.
  6. Technical information: product name and function (fertilizer, soil application or growth regulator).
  7. Guaranteed analysis in weight/weight.
  8. Indication of the types of salts used in the formulation.
  9. When the case warrants, the physical and chemical characteristics of the components and the analytical methodologies will be requested.
  10. Incompatibility with other agrochemicals.
  11. Corrosiveness, as applicable.
  12. Type and capacity of container.
  13. Toxicological information.
  14. Ecological information: persistence and alterations of the product in the soil, water and air; effects on land and aquatic flora and fauna; the product's natural degradation process; data on toxicity to beneficial insects; data of the mobility of the product and its empty containers; and an emergency plan and decontamination methods in the case of spillage, leakage, fire or explosion.

Licensing

Manufacturers and distributors of chemical substances are also required, under the Health Control Regulation (Articles 138-144) to obtain a sanitary license. The sanitary license, which is somewhat similar to an operating license, classifies the company according to the risks associated with the facility and its vehicles. Sanitary licenses are valid for the period established by CICOPLAFEST, at its discretion.

Permits

Upon registering the chemical substance and obtaining the corresponding sanitary license, the manufacturer or distributor must apply for a sanitary permit, in accordance with Articles 145 to 165 of the Health Control Regulation. Sanitary permits allow a business to manufacture or distribute products containing specific quantities of chemical substances for up to one year.

Import

Article 144 of the Ecology Law prohibits the import of pesticides, fertilizers and other hazardous substances whenever their use is banned in the country of origin.

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11.3 Storage, Transport and Use

 

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All storage, transportation and use activities related to chemical substances are regulated through the same four administrative instruments that govern manufacturing and distribution activities (discussed above in Part 11.2). In addition, a special authorization to transport chemical substances is required under the Waste Transportation Regulation and the Hazardous Waste Regulation under the Ecology Law. See Chapter 22, for further discussion on transportation requirements.

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11.4 Consumer Protection

 

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Chemical substance regulations related to consumer protection fall into two general categories: (1) standards establishing maximum allowable limits (límites máximos permisibles (LMPs)) of chemical substances in products; and (2) labeling requirements.

Toxic Substances

SSA is responsible for issuing all LMPs for toxic substances in prepared foods. In general, all prepared foods, defined as any "processed" foodstuffs, may not contain any pathogenic organisms, microbial toxins, microbial inhibitors or toxic substances. Mexico does not specifically regulate carcinogens in foodstuffs.

Standards for Pesticides and Fertilizers

The Federal Animal Health Law provides authority to the SAGARPA to issue standards for animal products and byproducts, which broadly include any biological, chemical, pharmaceutical and feed products that are used or consumed by animals. The Federal Health Plant Law also gives SAGARPA authority to develop standards for all phytosanitary activities. SAGARPA is further required to establish LMPs of pesticide residues in foodstuffs.

Labeling

The Consumer Protection Law establishes truthfulness standards in laws dealing with advertising and product liability standards. SE is in charge of creating specific technical standards in regard to advertising, labeling, packaging, warranties, safety and quality assurance of all products and services intended for general consumption. SE has published a substantial number of NOMs relating to the packaging and containers of products containing chemical substances. In addition, under Article 281 of the General Health Law and the Work Safety Regulation (Reglamento de Seguridad en el Trabajo), all containers used to hold toxic substances or products must be clearly marked "toxic" and provide detailed information about the risks associated with the product.

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11.5 Liability and Enforcement

 

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Liability and enforcement for violations under chemical substances regulations depend upon each specific violation. An offense related to an agricultural standard would trigger an administrative enforcement action from SAGARPA; a violation in regard to the transportation of a toxic substance could result in a sanction being imposed by the SCT; an infringement of the labeling standards could give rise to penalties assessed by the SE, and so on.

Violations under the General Health Law and Health Control Regulation are subject to warnings, fines or administrative arrest, all of which are imposed by the SSA. Although the amount of the fine assessed depends upon the specific provision of the law or regulation being violated, almost all permitting and chemical substance standards violations are subject to fines of up to five hundred times the minimum daily wage. Fines under the Animal Health Law range from one thousand to twenty thousand times the minimum daily wage, while those contemplated under the Plant Health Law range from fifty to thirty thousand times the minimum daily wage. Administrative arrest under the General Health Law and the Health Control Regulation may be ordered when a person interferes with the inspection or enforcement authority of the SSA or fails to comply with the Law or Regulation in such a way that the health of others is endangered.

Plant closures, whether partial or complete, temporary or permanent may also be imposed on facilities for failure to obtain a sanitary license; failure to implement the corrective actions imposed during an enforcement action; or when the violation has posed severe risks to the population. The Animal Health Law authorizes SAGARPA to order plant closures and suspend permit authorizations.

Other Liability

It is important to note that the application of the above sanctions does not preclude penalties or sanctions under the relevant provisions of the Ecology Law or the Hazardous Waste Regulation thereunder, the Consumer Protection Law, the Federal Labor Law or the Work Safety Regulation from being imposed, where warranted. Furthermore offenses may be sanctioned under civil and criminal law.

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2003