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Overview. There are no environmental laws in Mexico that specifically regulate the development or use of biotechnology. However, different aspects of biotechnological and bio-genetically engineered products could potentially fall under the jurisdiction of the Health Secretariat (Secretaría de Salud (SSA )); the Secretariat of Agriculture, Livestock, Rural Development, Fisheries and Food (Secretaría de Agricultura, Ganadería, Desarrollo Rural, Pesca y Alimentación (SAGARPA )); the Secretariat of the Environment and Natural Resources (Secretaría del Medio Ambiente y Recursos Naturales (SEMARNAT )); or the Secretariat of the Economy (Secretaría de Economía (SE)).
However, the use of genetic material is considered to be in the public interest under Article 2(II) of the General Law of Ecological Balance and Environmental Protection (Ley General del Equilibrio Ecológico y la Protección al Ambiente) (hereinafter Ecology Law). Moreover, Article 3(V) of the Ecology Law defines biotechnology as the ensemble of technical applications that make use of biological resources for the purpose of creating different products or applications.
Secretariat of the Environment and Natural Resources (SEMARNAT ). Pursuant to Article 28 of the Ecology Law, any use of biotechnology that " may cause" an ecological imbalance must first be evaluated through an environmental impact assessment (EIA). In addition, the use of biotechnology may require a permit or license under one of the media-specific environmental laws. For example, a microbe used for hazardous waste clean-up might also require a hazardous waste permit, a wastewater discharge permit, a toxic substances permit, etc.
Additionally, an authorization by SE MARNAT is required to collect, sample and use flora and fauna species for biotechnological research and use, in accordance with Article 87 Bis of the Ecology Law. That same provision establishes that no authorization for use or collection may be granted without prior knowledge and consent by the owners of the lands containing such flora and fauna. As well, the owners of such lands have a right to collect a share of the benefits obtained by the use of such species.
Intersecretarial Commission on Biosafety and Genetically Modified Organisms (Comisión Intersecretarial de Bioseguridad y Organismos Genéticamente Modificados (CIBIOGEM)). CIBIOGEM is an executive agency responsible for establishing the policies and making the decisions required for the management of biotechnologically modified living organisms, in order that they be harmless to human health and do not threaten the basic crops of the countryside economy or the country's biodiversity.
The central focus of biosafety is the adoption of measures to protect health and the environment with respect to genetically modified organisms. The provisions apply principally to health-human, animal and plant-and to the environment.
CIBIOGEM, through its member agencies (principally SAGARPA , SE MARNAT, SSA and the National Science and Technology Council (Consejo Nacional de Ciencia y Tecnología (CONACYT )), applies certain biosafety rules. The rules relating to health are found mostly in the General Health Law (Ley General de Salud) and four regulations (health research, health products, health control of products and services, and advertising), as well as in the Federal Plant Health Law (Ley Federal de Sanidad Vegetal), the Law on Seed Production, Certification and Trade (Ley sobre Producción, Certificación y Comercio de Semillas), and in Official Mexican Standard (Norma Oficial Mexicana (NOM)) NOM-FITO-056. As regards environmental protection, the legal provisions are found in the Ecology Law and its Environmental Impact Regulation.
Other agencies forming part of CIBIOGEM include the Finance Secretariat (Secretaría de Hacienda y Crédito Público (SHCP )), SE , and the Secretariat of Public Education (Secretaría de Educación Pública (SEP )). These secretariats do not apply any specific biosafety rules, but do have jurisdiction over provisions directly and indirectly governing aspects of biosafety.
SHCP applies rules relating to the transboundary movement of goods, customs, taxation and financial assistance, among other areas. SE deals with the legal standards involving foreign trade, national and international trade policy, the market placement of goods and international trade treaties, while its sector-oriented agencies, the Mexican Industrial Property Institute (Instituto Mexicano de la Propiedad Industrial (IMPI)) and the Federal Attorney General for Consumer Protection (Procuraduría Federal de Protección al Consumidor (PROFECO)), respectively oversee industrial property and the protection of consumer rights.
SEP is involved in biosafety through its application of the provisions of law relating to the development of national educational policies practically at all levels, as well as research and educational and scientific publication through CONACYT , among other areas.
Health Secretariat (SSA ). Although there is currently no comprehensive list of chemical substances triggering the pre-manufacture review of new substances, SSA , through the Intersecretarial Commission for the Control of the Development and Use of Pesticides, Fertilizers and Toxic Substances (Comisión Intersecretarial para el Control del Proceso y Uso de Plaguicidas, Fertilizantes y Sustancias Tóxicas (CICOPLAFEST)), is expected to issue such a list shortly. All new biotechnological substances may need to be registered in this new list. At present, all biotechnology to be used specifically in connection with fertilizers and pesticides must be registered with CICOPLAFEST. SE , SAGARPA , SE MARNAT and SSA must comply with such rules when authorizing applications and granting licenses, permits and registration of pesticides, fertilizers and toxic substances.
Secretariat of Agriculture, Livestock, Rural Development, Fisheries and Food (SAGARPA ). Pursuant to Article 2 of the Federal Animal Health Law (Ley Federal de Sanidad Animal) (hereinafter Animal Health Law), SAGARPA has authority over all biological products which, generally speaking, include all biological reactants, serums, vaccines used in the diagnosis, treatment or prevention of animal diseases, as well as all hormones and biogenetic materials used for reproductive purposes. Therefore, it would appear as though SAGARPA has comprehensive permitting and regulatory control over biotechnology used in the production of livestock. In addition, the Federal Plant Health Law (Ley Federal de Sanidad Vegetal) (hereinafter Plant Health Law) grants SAGARPA authority over all phytosanitary activities, which include all activities related to the production, industrialization, movement or commercialization of vegetables, vegetable products or materials used for vegetable production.
Secretariat of the Economy (SE). Under the Federal Consumer Protection Law (Ley Federal de Protección al Consumidor), SE would be in charge of any labeling requirements regarding the products resulting from biotechnology or biogenetic engineering. Such requirements would include standards regarding advertising, packaging, warranties, safety and quality assurance of any biotechnology intended for consumer use.
SSA may also establish noise restriction zones, on its own initiative or at the request of a third party. These restriction zones may be temporary or permanent, and are intended to provide for more stricter noise standards in areas near hospitals or residential areas.
Sanctions for violation to the Noise Regulation depend upon the provision being violated. Sanctions may range from one to nine years of prison and a fine from 300 to 3,000 days' minimum salary, depending upon the seriousness of the offense and the number of recurrences.
Indoor air pollution issues are regulated primarily as occupational health and safety issues under the Federal Labor Law (Ley Federal del Trabajo) (hereinafter Labor Law) and the Federal Regulation of Safety and Hygiene in the Workplace (Reglamento Federal de Seguridad e Higiene en el Trabajo) (hereinafter Workplace Safety Regulation). In addition, the Regulation of Sanitary Engineering Relating to Buildings (Reglamento de Ingeniería Sanitaria Relativa a Edificios) (hereinafter Building Sanitation Regulation) establishes standards regarding indoor air circulation in buildings. The management and enforcement of workplace indoor ventilation regulations falls under the jurisdiction of the Labor Secretariat (Secretaría del Trabajo y Previsión Social (STPS)), while building regulation provisions are enforced by SSA.
The Labor Law does not contemplate per se any provisions governing indoor air pollution. Rather, the Law establishes general policies pertaining to occupational hazards. The Work Safety Regulation, which implements the Labor Law, regulates work environment pollutants, including air contaminants. Under the Work Safety Regulation employers are required to reduce air contamination in the workplace and provide personal protective equipment to workers. In addition, building ventilation requirements are established under Articles 35 through 50 of the Workplace Sanitation Regulation. Sanctions for indoor air pollution violations are the same as those described in Section 24.4, Occupational Health and Safety, below.
Overview. Article 123 of the Political Constitution of the United States of Mexico (hereinafter Mexican Constitution) states that all citizens have a right to work in a manner that is dignified and socially useful and requires all employers to implement those measures which are necessary in order to ensure workplace safety and hygiene and prevent employee accidents and illnesses. The occupational health and safety provisions of Article 123 are implemented under the General Health Law, the Labor Law and, more specifically, the Workplace Safety Regulation.
General Health and Labor Laws. These Laws establish general provisions that serve as a basis for the regulation of occupational health and safety matters. All activities undertaken in the workplace, whether commercial, industrial, professional or otherwise, must comply with the general health standards issued by SSA . Article 129 of the General Health Law charges the Health Secretariat with:
SSA shares its jurisdiction over the workplace with STPS . Like the General Health Law, the Labor Law also establishes general provisions governing workplace conditions and expands the responsibilities of employers in order to ensure workplace health and safety. The Labor Law provides for compensation to both temporary and permanent workers for any disability arising from occupational hazards.
Workplace Safety Regulation. The Workplace Safety Regulation, which is enforced by STPS in conjunction with SSA , provides detailed information on the general occupational health and safety provisions set forth in the Health and Labor Laws. The Workplace Safety Regulation establishes general provisions regulating work environment contaminants, which are defined as "physical, biological or chemical agents, elements or compounds capable of altering workplace environmental conditions and that, due to their properties, concentration, and action or exposure time and level, may harm workers' health."
Under the Workplace Safety Regulation workers are not to be exposed to noise, ionizing radiation, non-ionizing electromagnetic radiation, solid, liquid, and gaseous pollutants, abnormal air pressure, extreme hyper or hypo-thermal working conditions and lighting levels that exceed the maximum allowable levels (LMPs). The Workplace Safety Regulation also provides general standards to prevent and control worker exposure to contamination during the handling, transportation and storage of flammable, combustible, explosive, corrosive, irritant and toxic substances in the workplace.
When pollutants exceed the LMPs established in the NOMs, employers are required to implement a series of corrective measures which include: (1) substituting pollution generating chemicals with other less contaminating substances; (2) reducing pollutant generation to a minimum; and (3) introducing changes in working processes or control technologies. If, because of the nature of the industry it is not possible to reduce pollution levels or prevent them from exceeding the LMPs, employers must undertake any or all of the following measures: (1) isolating pollution generating sources, processes, equipment or areas; (2) isolating workers; (3) limiting the duration and frequency of workers' exposure to pollutants; and (4) supplying workers with adequate protective equipment. Employers must also inform workers of the hazards involved and the safety measures to be taken. Most of the occupational health and safety standards are set out under NOM-001-STPS through NOM-082-STPS issued by STPS in 1993 and 1994.
Employers who exceed the air contamination LMPs or fail to implement any of the required preventive or corrective measures to protect workers' health and safety are subject to fines ranging from fifteen to three hundred times the local minimum daily wage. Penalties are based on the following factors: (1) the seriousness of the violation; (2) previous violations; and (3) the financial condition of the violator. Procedures for administrative hearings and appeals are also contemplated.
Environmental economic instruments currently used in Mexico include permits and user fees; tax incentives and direct government subsidies.
Federal Fiscal Code. Article 39 of the Federal Fiscal Code (Código Fiscal de la Federación) contains general provisions allowing the federal executive to direct national policy through fiscal incentives. The Executive may establish indirect tax exemptions and reductions for specific industry sectors or regions in order to encourage the investment in and the production, development and undertaking of certain activities.
Ecology Law. Article 22 Bis of the Ecology Law provides that environmental technology research, the proper use and preservation of water, the relocation of industrial activities, the management of natural resources and other undertakings aimed at preserving and protecting the environment "shall be considered priorities for the purpose of establishing tax incentives." SEMARNAT, together with SHCP, have been specifically charged with developing the necessary economic instruments and fiscal incentives to promote sustainable development and environmental protection. In some instances, these fiscal incentives are contemplated in the implementing regulations under the Ecology Law, such as Articles 7 and 12 of the Regulation under the Ecology Law Regarding the Prevention and Control of Air Pollution (Reglamento de la Ley General del Equilibro Ecológico y la Protección al Ambiente en Materia de Prevención y Control de la Contaminación de la Atmósfera).
Permitting and Licensing Fees. User fees and administrative costs are attached to all federal environmental concessions, permits, operating licenses and other administrative authorizations. Fees are set forth in the Federal Fees Law (Ley Federal de Derechos). As a means to promote environmental compliance, Mexico is currently engaged in a pilot study in accordance to which water use and discharge fees are waived when the permit holder installs certain clean technologies. Should the project prove successful, it is possible that such fee waiving programs will be also implemented in other areas of environmental protection legislation.
Tax Deductions. The Federal Income Tax Law (Ley del Impuesto sobre la Renta) imposes a general flat tax of 34% on the adjusted gross income of all individuals and corporations that are permanently established in Mexico or reside there. The adjusted gross income includes the sum of all gross income less allowable deductions. In 1995, the Federal Income Tax Law was amended in order to introduce a specific tax deduction allowance pertaining to clean technology tangible assets such as: (1) installed equipment for the prevention and control of environmental pollution and (2) natural gas conversion equipment. Clean technologies are allowed a 95% immediate depreciation allowance in the year of purchase, or the following year, or a 100% depreciation allowance over the life span of the equipment.
Direct Subsidies. In addition to the granting of tax deductions in connection with the implementation of clean technologies, environmental protection is promoted through direct government subsidies. Subsidies are granted for specific programs coordinated under the six year National Development Plan (Plan Nacional de Desarrollo) which is introduced at the beginning of each new Presidency. In some instances, direct government investment is provided for under media-specific laws.
Government procurement contracts are granted in accordance with the terms and conditions set forth under the Procurement and Public Works Law (Ley de Adquisiciones y Obras Públicas) (hereinafter Public Works Law). Article 20 of the Public Works Law requires that all agencies and entities that grant public works contracts ensure that the underlying projects will not harm the environment. All contractors must comply with the environmental impact assessment (EIA) requirements contemplated under the Public Works Law and the Ecology Law. In addition, all public works projects must use the technologies, equipment and facilities which are necessary to preserve or restore the environment. The Public Works Law, however, does not spell out more specific government procurement policies, nor does it require that the government give preference to environmentally sensitive companies during contract bidding.
Mexico has yet to adopt specific legislation or technical standards regulating underground storage tanks. It would appear as though the regulation of underground storage tanks falls under the general environmental provisions of the Ecology Law, the Regulation under the Ecology Law Regarding Hazardous Waste (Reglamento de la Ley General del Equilibro Ecológico y la Protección al Ambiente in Materia de Residuos Peligrosos) and the Regulation Regarding Environmental Impact (Reglamento de la Ley General del Equilibro Ecológico y la Protección al Ambiente en Materia de Impacto Ambiental). Theoretically, the owner of a leaking underground storage tank that harms the environment or disturbs the ecological balance is liable under the Ecology Law for any damages caused. Nevertheless, there is no law requiring owners to monitor their underground storage tanks. PEMEX voluntarily launched a program to upgrade its service stations and replace old underground storage tanks with new ones. There was, nevertheless, no decree or agreement that required PEMEX to replace its old tanks.