Part 4
Biosafety regulations in the Mercosur countries

Chapter 1
Biosafety regulations in Argentina

Regulation of production areas related to biotechnology

In the agricultural sector, overall responsibility for the regulatory framework lies with the Secretariat of Agriculture, Livestock, Fisheries and Food (SAGPyA) [Secretaría de Agricultura, Ganadería, Pesca y Alimentos], which develops this activity through the National Seeds Institute (INASE) [Instituto Nacional de Semillas] and the National Service for Agrifood Health and Quality (SENASA) [Servicio Nacional de Sanidad y Calidad Agroalimentaria].

The National Seeds Institute is responsible for ensuring the availability, identity and quality of seeds which farmers acquire, and ensuring agricultural and market transparency, for seeds from both national and imported sources, combating unfair competition. It is intended to encourage the development of plant breeding activity, to defend the rights granted to breeders of new varieties and to promote efficient production and marketing, while stimulating exports.

SENASA is a decentralized agency, with the mandate to protect public health, monitoring and overseeing the procedures applied in the chain of animal and vegetable agrifood products. The agency enforces Law No. 18,284, the Argentine Food Codex, Decree No. 12,585/96 on the Establishment and Jurisdiction of SENASA, Decree No. 4,238 on the Inspection of Meat, and Decree 811/99 on Control of Food Systems. The agency has the authority to propose regulations and to organize its own regulatory system. SENASA can also formulate regulations applicable to other entities.

SENASA ensures that certification systems and sanitary inspection are directly proportional to risk assessment of disease transmission. It is responsible for developing and organizing a registry of certification bodies for entities involved in production and preparation of organically or ecologically obtained food of animal origin. It also is responsible for certifying grants to export agricultural animal and plant food products by assessing sanitary and/or quality actions required by international markets.

Regulations in the field of human health are the responsibility of the National Administration of Drugs, Foods and Medical Devices (ANMAT) [Administración Nacional de Medicamentos, Alimentos y Tecnología Médica], a decentralized agency which reports to the Department of Sanitary Policy and Inspection (SPyRS) [Secretaría de Política y Regulación Sanitaria] of the Ministry of Health (MS) [Ministerio de Salud]. ANMAT operates through two main arms: the National Institute of Medicine (INAME) [Instituto Nacional de Medicamentos] and the National Food Institute (INAL) [Instituto Nacional de Alimentos].

INAME has the authority to control and monitor the health and quality of products that can affect human health. These products include: drugs, chemicals, reagents, pharmaceutical forms, medicines, diagnostic elements, and packaged foods, including specific inputs, additives, dyes, sweeteners, colorings and ingredients used in food. The agency addresses the problem of control from three angles: computerized records based on data from companies and products; inspections to ensure good manufacturing practices; and monitoring of approved products to control their quality.

To meet its responsibility for food control, INAL has its own laboratories, recently recycled and ready to be refitted. It maintains communication with a network of subsidiaries within the country and with state and local agencies responsible for food control. It promotes, supervises and evaluates the development of the National Food Control Program, in its different stages, in coordination with state and municipal agencies. The regulations on foods include state and local provisions.

In the environmental area, regulations are the responsibility of the Department of Environment, at Argentina’s Ministry of Social Development and Environment (MDSyMA) [Ministerio de Desarrollo Social y Medio Ambiente]. There is a growing tendency in this area to establish standards of environmental preservation in provincial and municipal jurisdictions, including for example pioneering initiatives taken by the Province of Buenos Aires.

Companies interested in certifying ISO 9000 compliance must comply with the National Standards, Quality and Certification System, established in 1994. The System “offers reliable instruments at the local and international levels, for companies that wish to voluntarily certify their quality systems, products, services and processes through a mechanism that relies on standardization and certification bodies, in accordance with integrated current international standards.” In the environmental field, the ISO 14000 series of standards has started being applied in the country, also voluntary and still under development. The adoption of total quality standards and environmental quality does not exempt companies from the obligation to comply with technical and marketing regulations, which are binding throughout the territory.

Regulating the introduction of genetically modified organisms (GMOs) in the agricultural sector is integrated into the overall regulatory system for the agricultural sector, composed of Decree-Law No. 6,704/66 for the Sanitary Protection of Agricultural Production, and its modifying laws; Law No. 20,247/73 for Seeds and Plant Genetic Creations and its regulatory decree; and Law No. 13,636/49 for Veterinary Products, Supervision of their Preparation and Marketing.

Regulation of activities in the biotechnology field

The increasing application of biotechnology to areas of great economic and social value, such as human and animal health, animal and plant production, mining, oil or sewage treatment, has prompted concern from various public and private organizations in Argentina, which are interested in making sure that research, production and release of GMOs be performed in conditions ensuring the preservation of safety for people and the environment.

The Argentine regulatory framework applicable to GMOs has three components: assessment of environmental risk, handled by the National Advisory Commission on Agricultural Biotechnology (CONABIA) [Comisión Nacional Asesora de Biotecnología Agropecuaria], assessment of food safety, which is under the jurisdiction of SENASA, and assessment of the impact of trade liberalization of GMOs on the international markets of the country, which is the responsibility of the National Directorate of Agrifood Markets (DNMA) [Dirección Nacional de Mercados Agroalimentarios].

The first assessment of a GMO focuses on its impact on the environment, and takes place from the beginning of its development, i.e., from small-scale trials in greenhouses or in the field. The regulatory framework examines each case, following the development of the GMO and may stop it and prevent its release if there are doubts about its risks to the environment and/or about its use as a raw material for food. If the risks are not acceptable, the development of the GMO will be stopped during confined trials. This ensures that no product reaches the market without having satisfactorily complied with safety requirements.

The Argentine regulatory system reviews each case and is based on the characteristics and risks identified for the biotechnology product, not the process by which the product originated. It is applied to transgenic products based on their proposed use, considering only those aspects of the procedures used to obtain it which may imply risk to the environment, to agricultural production and to public health.

Responsibility for the various activities related to environmental release of GMOs lies with SAGPyA. In the case of plant varieties, evaluation is the responsibility of CONABIA, and monitoring is the responsibility of INASE and SENASA. In matters involving experimentation, production and release of products involving animal, plant or agrifood health, the assessment is the responsibility of SENASA, which has organized a Technical Advisory Committee on the Use of GMOs [Comité Técnico Asesor para el Uso de OGM] (CTAUOGM) for this purpose. In the case of genetically modified animals, the responsibility lies with CONABIA. The area of human health and processed foods is the responsibility of ANMAT, through the National Commission on Biotechnology and Health (CONBYSA) [Comisión Nacional de Biotecnología y Salud].

The biosafety of food derived from GMOs is regulated by two resolutions from SAGPyA: Resolution No. 289/97, which establishes the jurisdiction of SENASA in the surveillance of foods derived from GMOs, and Resolution No. 511/98 and attachments (SAGPYA, 1998), which establish the criteria to apply in food safety matters. Resolution No. 511/98 is based on the FAO and the relevant regulations of Australia, Canada, EU, Japan and the United States, regarding the requirements and criteria for the biosafety and characterization of foods derived from GMOs, in relation to their capacity for human and animal consumption. The criterion of substantial equivalence is applied.

“Equivalence” consists of characteristics of composition, nutritional value and uses. The term “substantial equivalence,” in turn, implies risk assessment and compositional analysis, which in the Argentine system is handled by SENASA, regarding all aspects by which the new food can be differentiated from the traditional. These include, for example, changes in the content of toxins and allergens (from the traditional), toxicity and allergenicity (of the new protein structure), macromolecular components (compared with the traditional), digestion and metabolism (of the new, but not only), bioavailability of nutrients and micronutrients, acute toxicity (of the food or new proteins), chronic toxicity (when necessary), formulation and testing of animal feed (subproducts), need for consumer information, changes in functional groups, and others.

The involvement of DNMA was established by Resolution No. 289/97, from SAGPyA, and it undertook the task of evaluating the impact on Argentina’s international trade of possible marketing of GMOs under consideration. DNMA prepares a technical report which establishes which GMO seed varieties may be sold by companies to Argentine farmers. CONABIA, SENASA and DNMA develop the basis of a “draft resolution,” prepared by CONABIA. This resolution, signed by SAGPyA, grants authorization for commercial use of GMOs. Before being able enter the market with the product, the interested party must apply for registration of the new variety with INASE, as a condition of controlling ownership and business practices in the seed industry. When the GMO has insecticidal properties, such as plants which express Bt or which have been modified to be herbicide tolerant, marketing requires specific prior authorization from SENASA.

In terms of genetically modified animals, a draft of guidelines for their management and control is being prepared. According to this initial draft, the import of genetically modified animals, gametes or embryos requires authorization granted on the basis of conditions controlled by SENASA, which shall serve as a receiving office for processing of applications for animals, similar to what INASE does for applications for plants. SENASA shall hand off the processing to CONABIA, whose approval is prior to SAGPyA’s decision to approve or deny. The Committee will examine food safety data submitted by applicants, which are in many cases contained in envelopes prepared for approval in the United States and the European Union. The Committee may request additional data if it deems necessary.

National Advisory Commission on Agricultural Biotechnology (CONABIA)

CONABIA was created by Resolution No. 124/91 dated October 24, 1991, by the Secretariat of Agriculture, Livestock and Fisheries (SAGyP) [Secretaría de Agricultura, Ganadería y Pesca]. That resolution considers that the development of agricultural biotechnology produces a considerable impact on the activity of the sector and the environment, due to the incorporation of new genetic material that helps to improve quality and increase the amount of food available. For this process to be developed within the framework of a biosafety system that guarantees agro-ecological balance, it is essential to have a proper integration between scientific knowledge, the productive apparatus and the current regulatory framework, linking the state’s efforts to the private sector.

The functions of CONABIA are to advise the Secretariat beforehand regarding the technical and biosafety requirements which should be satisfied by genetic material obtained through biotechnological procedures, so that they can be incorporated into the biosystem by any procedure or method and in any capacity (testing, dissemination, etc.), by proposing standards and issuing findings on matters within its field of competence.

In Resolution No. 669/93 dated August 23, 1993, SAGyP established that CONABIA shall consist of representatives from institutions involved in agricultural biotechnology in the public and private sectors. Currently, within the public sector, the following are represented: the National Service for Agrifood Health and Quality (SENASA), the National Seeds Institute (INASE), the National Institute of Agricultural Technology (INTA), the National Council for Scientific and Technical Research (CONICET) [Consejo Nacional de Investigaciones Científicas y Técnicas], the University of Buenos Aires (UBA), and the Department of Sustainable Development and Environmental Policy (SEDSyPA) [Secretaria de Desarrollo Sustentable y Política Ambiental]. The private sector participates through the Biotechnology Committee of the Argentine Seed Growers Association (ASA), the Argentine Forum on Biotechnology (FAB), Argentina’s Chamber of Agricultural Health and Fertilizers (CASAFE) [Cámara de Sanidad Agropecuaria y Fertilizantes], the Argentine Chamber of the Veterinary Products Industry (CAPROVE) [Cámara Argentina de la Industria de Productos Veterinarios] and the Argentine Ecological Society (AsAE) [Asociación Argentina de Ecología].

Based on the experience of countries with the a longer tradition in this area, the Commission has developed specific regulations concerning the technical and biosafety requirements to be met in experimentation and/or environmental release of genetically modified plant organisms and genetically modified microorganisms and/or their products for applications on animals. These standards have been adopted by SAGyP, in Resolution No. 656/92 dated 30 July 1992.

The decisions of CONABIA are based on scientific criteria, together with specific regulations (SAGYP, 1992), which have been prepared by the Commission on the basis of the directives of the ministerial authority’s policies and existing laws. These regulations have been based on those used by the United States Department of Agriculture and Animal Plant Health Inspection Service (USDA-APHIS). The Commission studies requests and recommends whether or not they should be authorized. Once the technical findings have been issued, the administrative decisions fall within the scope of ministerial authority.

The principle which guides the implementation of standards for particular cases is that the measures taken to reduce the risk should be related to the level of potential risk. For this purpose, the three factors that determine the safety of an environmental release are:

By Resolution No. 289/97, the Secretary of Agriculture, Livestock, Fisheries and Food is the competent authority to authorize trials and/or environmental release of genetically modified plant organisms, requiring prior finding by CONABIA. Authorizations will be granted in the following cases:

Once the application has been evaluated, CONABIA will pronounce its findings in relation to the desirability or not of releasing GMOs and will submit it to receive authorization from the Secretary of Agriculture, Livestock, Fisheries and Food. Upon expiry of the authorized period, the applicant must submit a final report to CONABIA. The experiment will be completed when the following conditions have been met:

By monitoring the trials, it is intended to evaluate, on-site, actual compliance with what was presented in the applications, and prepare to implement measures to prevent adverse effects on the environment outside the trial (such as the spread of invasive plants). Control of lots will also be done, after the time of harvest, to limit the possible transfer of the genetic information contained in the GMO to other organisms.

Applicants that have obtained authorizations for trial and/or environmental release of the GMO may request relaxation of conditions on authorizations from CONABIA. Once authorization is granted by the resolution from SAGPyA, in future environmental releases, information should be presented regarding: area planted, planting date, release location and date of harvest. CONABIA will only recommend conducting inspections of harvest and disposal of material. Relaxation of conditions does not imply authorization for commercial sale of seed.

If it is desired to sell the seed, the following requirements must be met:

The application must be filed with the Technical Coordination of CONABIA by initiating, with SENASA, the procedures necessary to comply with the requirements that fall within its jurisdiction in relation to human, animal and food uses of the transgenic material and its derived products. SENASA will request the information needed from the applicant in order to supplement its various assessments.

CONABIA establishes, for each proposed release (event), the safety conditions to ensure minimal potential risks. Each case is handled by the Commission as a whole, and all decisions are taken unanimously. The procedure includes inspections during cultivation, harvest and post-harvest monitoring. Confidentiality of commercial data is ensured through a centralized procedure at INASE or SENASA.

Up to the time of this writing, the activities of CONABIA have been concentrated in evaluating applications for authorization of field trials of transgenic plants, including a proof of storage and shelf life of transgenic tomatoes. Since its inception, CONABIA has evaluated and authorized 433 events, of which six have received marketing authorization, and five coincide with similar decisions of the European Union. During 2000, the dynamics for authorizing events underwent a consolidation.

Corn, sunflower, soybean and cotton are the crops that had the greatest number of trials authorized, followed by wheat, potato, rapeseed (canola), sugar beet and others. The main traits introduced were herbicide tolerance and insect resistance.

The Commission recommended approval of relaxation of conditions of experimentation and/or environmental release of genetically modified plant materials, finding no anticipated biosafety problems for the agroecosystem due to large-scale cultivation of GMOs: A2704-12 and A5547-127 soybean tolerant to the herbicide ammonium glyphosate from the company AgrEvo S.A. Requests for relaxation of the trial conditions of the following transformation events are under evaluation by CONABIA: CBH 351 corn resistant to insects and tolerant to the herbicide glyphosate ammonium (applicant: AgrEvo S.A.) and cotton tolerant to the herbicide bromoxynil (applicant: Aventis CropScience Argentina S.A.).

During 2000, the Commission granted approval for 65 trials (field and greenhouse) with genetically modified plants and one trial with genetically modified material for veterinary use, and denied approval for four trials (field and greenhouse) with genetically modified plants. More recently, the new authorities of SAGPyA approved the release of a variety of herbicide-tolerant cotton.

Most applications come from transnational corporations, which have taken advantage of having off-season field trials to accelerate the development of transgenic plants performed in their central laboratories. Most applications analyzed have prior approval from USDA-APHIS, or similar approval from European countries. These prior approvals are carefully analyzed, regarding risks specific to local ecosystems. When necessary, additional information is requested from applicants, or limitations or precautions are recommended specifically for performing trials in the country

Applications for events by multinational companies have been mainly for corn, soybeans and cotton. Applications for events by Argentine seed companies focus on potatoes, wheat, corn and cotton, with the participation of research institutions in the public sector, such as INTA, CONICET and national universities. It should be noted that within these institutions there are several research projects related to cereal seeds, oilseeds, vegetables and industrial crops.

SENASA’s Technical Advisory Committee on the Use of GMOs (CTAUOGM)

SENASA created, via Resolution No. 1,265/99, a Technical Advisory Committee on the Use of GMOs [Comité Técnico Asesor para el Uso de OGM] (CTAUOGM), comprising representatives from the following institutions: CONABIA, the Agronomy, Veterinary, Pharmacy and Biochemistry Schools of the University of Buenos Aires, the National Food Institute (INAL), the National Council for Scientific and Technical Research (CONICET), the National Institute of Medicine (INAME), the Argentine Seed Growers Association (ASA), the Argentine Agrarian Federation (FAA) [Federación Agraria Argentina], the Coordinator for Food and Beverage Industries (COPAL) [Coordinadora de las Industrias de Productos Alimenticios], the Argentine Rural Confederation (CRA) [Confederaciones Rurales Argentinas], the Agricultural Intercooperative Confederation or CONINAGRO [Confederación Intercooperativa Agropecuaria], the Argentine Rural Society [Sociedad Rural Argentina], the Argentine League of Consumers [Liga Argentina de Consumidores] and organizations of industrial producers engaged in this area.

The main purpose of the Committee is to provide an external and multidisciplinary advisory body to SENASA, offering a broader base for regulatory decisions. The Committee’s activities began with a thorough review of Resolution No. 511/98 to improve the evaluation of food safety. The main topics under review include a narrower and more complete definition of conditions and a review of the concept of substantial equivalence, an issue currently under discussion in many forums. It is being considered whether to incorporate the International Standards currently being studied by the Committee on Biosafety of the Codex Alimentarius.

SENASA also manages regulatory processes and quarantine of plants and animals and compliance with phytosanitary requirements. In recently adopted procedures for the import of plants, plant parts and animals, a form was incorporated where the importer must state whether it is introducing genetically modified material into the country. If the answer is affirmative, the import will be sent to CONABIA and the applicant must submit to the Commission a detailed description of the GMO, the nature of work and the resources available to perform the research. The technical staff of CONABIA evaluates safety conditions and formalizes its approval as a prerequisite for authorizing importation. Until authorization is granted, SENASA temporarily stores the GMOs in a safe location.

National Seeds Institute (INASE)

INASE is the agency of SAGPyA in charge of registering and controlling seeds that will be commercialized in the country. Depending on the species, the registration of a new variety requires 2 or 3 years of comparative field trials, to be held in different situations. Transgenic crops are treated similarly to new hybrids, in comparing for essentially derived varieties.

The registration of the variety may be done immediately after marketing authorization has been obtained. Field trials of GMOs, conducted under conditions recommended by CONABIA, can be used as valid trials for registration purposes. An Advisory Committee of the National Seeds Commission (CONASE) [Comisión Nacional de Semillas] confirms the results and decides whether the material qualifies as a new variety.

At the end of 2000, changes were introduced in the structure of INASE, taking away its status of “National Institute,” although it retained its mandate and functions, and the same staff.

National Directorate of Agrifood Markets (DNMA)

The Argentine regulatory framework applicable to GMOs has three components: risk assessment for the environment, which is the responsibility of the National Advisory Commission on Agricultural Biotechnology (CONABIA), assessment of food safety, which is under SENASA, and assessment of the impact of the commercial release of GMOs on international markets in the country, which is under the jurisdiction of the National Directorate of Agrifood Markets (DNMA) [Dirección Nacional de Mercados Agroalimentarios]. The intervention of DNMA was established by Resolution No. 289/97, from SAGPyA.

National Commission on Biotechnology and Health (CONBYSA)

Within the institutional scope of the National Administration of Drugs, Foods and Medical Devices (ANMAT), which is the national regulator in these areas, the National Commission on Biotechnology and Health (CONBYSA) [Comisión Nacional de Biotecnología y Salud] was created, with the mission to “assist in the development and application of biotechnology in the field of human health.” CONBYSA was created by Resolution No. 413/93 from ANMAT, in December 1993, at the initiative of the Commission and the Argentine Forum on Biotechnology (FAB).

CONBYSA is composed of three representatives from ANMAT and three from the Argentine Forum on Biotechnology (FAB), and is coordinated by the Director of ANMAT. It is involved in controlling biological products obtained by biotechnology techniques, i.e., rDNA or monoclonal antibodies. For the implementation of its work, advisory subcommittees were created, made up of professionals from the public and private sectors from industry associations, universities and scientific and technical institutions.

The purpose of the Commission is to analyze and study existing regulatory standards governing the development, preparation and approval of biotechnology products for use in healthcare and human consumption.

The Commission has established four working subcommittees, which include participation of various industry associations, universities and institutions. The subcommittees are: 1) In vitro Diagnostic Reagents, 2) In vivo Biopharmaceuticals and Diagnostic Products, 3) Industrial Plants, 4) Food.

The subjects of study are the following:

Cartagena Protocol on Biosafety at the Convention on Biological Diversity (CARULLO, 2002)

The Convention on Biological Diversity is the national law in Argentina, but has not been regulated to date. For this reason, there are no current regulations regarding access. Research institutes are governed by international agreements such as the Code of Conduct for Plant Germplasm Collecting and Transfer of the United Nations Food and Agriculture Organization (FAO).

Argentina has acceded to the Cartagena Protocol on Biosafety, which regulates the exchange of genetically modified organisms. The agreement imposes responsibilities on countries in order to ensure that the movement of GMOs between the borders of each country is adjusted so as to control risks and avoid negative impacts on biodiversity or human health. The application of procedures based on the “precautionary principle” provides that a country can refuse to import a particular GMO, in the absence of scientific evidence about its potentially harmful action. Considering its status as a leading exporter of articles derived from GMOs, Argentina is likely to face a significant challenge to balance the adoption of GMO varieties in the face of a growing demand for non-GMOs.

Argentina is preparing to develop regulatory frameworks and capacity to provide risk evaluations for these countries. Argentina has not publicly taken an official position on its interest in modifying its existing regulatory system to incorporate the problems generated by the adoption of the precautionary principle. As background, it should be noted that the Second National Report of the Parties58, prepared in May 2001 by the Department of Sustainable Development and Environmental Policy (SEDSyPA) of the then Ministry of Social Development and Environment (MDSyMA), refers to the advances that have been produced in Argentina in relation to Articles 19 and 20 of the Convention, concerning the management of biotechnology and distribution of its benefits and, in particular, Decision IV/3: Issues Related to Biotechnology Safety, and Decision V/1: Work Plan of the Intergovernmental Committee for the Cartagena Protocol on Biosafety.

The Argentine government has declared that it is granting a medium priority to the enforcement of Article 19 and its decisions, noting it has are limited resources to make the needed investments. With regard to Decision IV/3, the report notes that the country has signed the Protocol and its ratification is in process. Regarding the question of whether the country had assessed the need at the national level to implement effective regulation of genetic use restriction technology (GURT) in order to ensure safety of human health and the environment, food safety and conservation and sustainable use of agricultural biological diversity, the answer was that such legislation was unnecessary, because it is included in current legislation.

As part of its strategy to adapt to the Protocol, Argentina’s government is proposing that institutional areas linked to the regulation of biotechnology be made hierarchical, with the backing of a law from the National Congress. The intent of the draft Biosafety Law on the Application of Biotechnology in Agriculture 59 was to give legal character to the current regulatory framework for approval of GMOs, regarding their biosafety, and their safety as agrifoods and for the healthy functioning of markets. The discussion on the impact of transgenic food biotechnology should be imposed on all the legislative bodies of the country at the regional level, taking the discussion to the Mercosur Parliament, to build regional biotechnology regulations.

Draft Law on Biosafety in Agricultural Biotechnology

Special Commission of Biotechnology of the Chamber of Deputies

Considering the strategic importance that the development of biotechnology has for Argentina, the country’s Chamber of Deputies created, in May 2001, the Special Committee on Biotechnology. Its purpose was to pass the appropriate legislation needed to facilitate biotechnology development and to address issues related to biosafety. Its main objectives were to: review and issue findings on the regulations necessary to organize and promote the development of biotechnology, coordinating national legislation with international commitments of the country; make an evaluation of international, national, state and municipal regulations on the matter; and hold a convocation of stakeholders from all levels to develop a proposal for legislation on the matter.

As the initial result of its activity, the Commission has prepared a Draft Law on Biosafety in the Application of Agricultural Biotechnology, which is in an advanced stage of parliamentary proceedings and which is, simultaneously, under discussion by organizations in society involved in biotechnology.

Draft Law on Biosafety in Agricultural Biotechnology60

The Draft Law aims to: establish the regulatory framework to update and provide hierarchy and legally binding nature to the process of incorporation of GMOs into agricultural and agribusiness production systems, ensuring biosafety conditions and promoting the development of modern biotechnology in agricultural production, considering it as a key strategic factor to increase agricultural productivity and competitiveness, as well as raising levels of quality, differentiation and value added for food and other products.

The process of incorporation of GMOs into the market will be performed via the fulfillment of the three stages of preliminary assessment:

The draft law expressly prohibits, and considers as a crime, the introduction, experimentation, production, use, release, marketing and any other possible use of GMOs without authorization granted by the enforcement authority. The Executive branch shall establish responsibilities and procedures, and regulate the scope of the instances of the evaluations provided, satisfying strictly scientifically based principles regarding the nature of the products.

All information linked to the regulatory process and the commercial approval of a transformation event is public and the enforcement authority shall ensure that it is available to all interested parties, on an ongoing and continuous basis, except aspects which are subject to confidentiality.

The enforcement authority provided by law is the Secretary of Agriculture, Livestock, Fisheries and Food of the Nation (SAGPyA), with the power to: (a) grant or deny authorizations to experiment, environmentally release and market GMOs, with prior technical findings from the advisory bodies created and validated by the law; (b) establish the biosafety conditions required to regulate the incorporation of GMOs into agricultural and agribusiness production systems and; (c) exercise the corresponding enforcement powers.

The project validates the creation of the National Advisory Commission on Agricultural Biotechnology (CONABIA), pursuant to SAGyP Resolution No. 124/91, which shall be interdisciplinary and interinstitutional, and whose members shall serve on an honorary basis. It shall consist of members from organizations operating in this area, on the initiative of the SAGPyA, which shall designate their authorities. Members shall also include the Secretariat of Technology, Science and Productive Innovation (SeTCIP) [Secretaría de Tecnología, Ciencia, e Innovación Productiva] and representatives from organizations designated by the Department of Sustainable Development and Environmental Policy (SEDSyPA). CONABIA has the following functions: (a) advising the enforcement authority on the present law regarding the technical requirements of biosafety that GMOs must meet, prior to being incorporated into any procedure or method and in any capacity – trials, distribution, etc. – into agriculture and agribusiness production systems; (b) proposing regulations and issuing findings on matters within its jurisdiction; (c) enabling and coordinating subcommittees for the treatment of specific topics, and; (c) formulating their rules.

The law creates a Technical Advisory Committee on the Use of GMOs61 (CTAUOGM) which shall be interdisciplinary and interinstitutional. It shall consist of representatives from the organizations operating in the area, as well as a president and a coordinator who shall hold office on an honorary basis. The functions of the Technical Advisory Committee include: (a) proposing requirements and evaluating their compliance for authorization, by the enforcement authority, of the use of GMOs; (b) proposing standards and issuing findings on the safety aspects of GMOs; (c) collaborating upon request with official bodies within the framework of existing legal regulations; and (d) enabling and coordinating subcommittees for the treatment of specific topics, which may be permanent, and which will be staffed in accordance with internal regulations.

The law creates, within the enforcement authority, the Technical Advisory Committee for Agrifood Markets [Comité Técnico Asesor de Mercados Agroalimentarios de Organismos Genéticamente Modificados], which shall examine the impact on the conditions of access to international markets. It shall be interdisciplinary and interinstitutional. It shall consist of representatives of public and private organizations operating in this area. The overall coordination is the responsibility of the National Directorate of Agrifood Markets (DNMA) [Dirección Nacional de Mercados Agroalimentarios]. The members of the Technical Advisory Committee shall hold office on an honorary basis. Its functions shall be: (a) analyzing trade policies developed by the major GMO producing, consuming and exporting countries; (b) assessing the impact of commercial authorization of a transformation event on accessing foreign markets; and (c) formulating its internal rules.

Finally, the law creates an Agricultural Biosafety Fund [Fondo de Bioseguridad Agropecuaria], which shall be funded with taxes collected by customs, and whose resources shall be used exclusively to cover the costs resulting from compliance with the objectives of the law. Tariffs shall be established by SAGPyA. The project includes a glossary of technical terms used in the document on Conclusions and Recommendations of the Joint FAO/WHO Expert Consultation on Biotechnology and Food Safety (Rome, September 30 - October 4, 1996).

Chapter 2
Biosafety regulations in Brazil

Genetically modified organisms (GMOs)

As of this writing, Brazil has approximately 130 accredited institutions for research on GMOs. The majority (80%) are public institutions that develop projects aimed at obtaining drugs and vaccines in plants. However, these studies will only available in the market over the long term.

In 2004, the total area planted with transgenic crops continued to grow for the ninth consecutive year, at a double-digit rate (20%), compared with 15% in 2003 (Fig. 1). In 2004, the estimated global area of approved biotech crops was 81.0 million hectares, (200 million acres), up from 67.7 million hectares (167 million acres) in 2003. Biotech crops were grown by approximately 8.25 million farmers in 17 countries, up from 7 million farmers in 18 countries in 2003 (JAMES, 2004).

Figure 1. Global area of transgenic crops.

Figure 1. Global area of transgenic crops.

Source: James, C. Preview: global status of commercialized biotech/genetically modified crops. Ithaca, NY: ISAAA, 2004. 12p. (ISAAA briefs, 32).

GMOs are living organisms capable of biological reproduction, dispersal and evolution in the environment, creating safety issues different from those generated by products arising from chemical and physical technologies.

The possibility of gene flow from the GMO (the same way as occurs with varieties grown on a large scale) to sexually compatible species is a key issue in environmental risk assessment, particularly near the centers of origin and diversity of cultivated species, to avoid so-called “genetic contamination” (MENDONÇA-HAGLER, 2001). It should be taken into account that gene flow also occurs with plants from conventional breeding and will therefore represent a factor for the environment only if it adds traits that alter the natural survival of the recipient plant in its environment; however, gene flow should not be considered as an environmental impact factor.

The probability of gene flow depends on many factors, including: the plant’s reproduction processes, the mechanisms of pollen and seed dispersal and the environment where it is released.

The recommended procedures for risk management in order to minimize gene flow relate to spatial or temporal isolation in relation to sexually compatible species, removal of flowering plants, use of male sterile plants, use of bordering plants incompatible with the transgenic plant, appropriate procedures for disposal of transgenic material, and post-harvest monitoring.

Horizontal transfer of genes in the environment may occur in prokaryotic organisms, through processes of conjugation, transduction and transformation. The frequency of recombination is higher when the genes are found in plasmids. Therefore, in constructing genetically modified organisms, the new genes should be inserted into the chromosome, in order to hinder gene transfer to the environment (ARAÚJO et al., 1993).

The management challenge is to identify changes in the genotype which confer competitive traits under natural conditions, which can be experimentally tested by observing the survival of the GMO, or hybrids thereof, outside the conditions of cultivation, compared to the isogenic parental organism.

Increasing the area planted with tolerant plants favors the appearance of weeds having tolerance to broad spectrum herbicide resulting from gene transfer events and selective pressure, which give these plants a competitive advantage in agroecosystems when subjected to that herbicide. This risk can be reduced by modifying the construction of the GMO to hinder the introgression of genes in sexually compatible species (GRESSEL, 2000).

Biosafety of GMOs

Biosafety procedures are intended to prevent or minimize adverse effects of GMOs and their derived products on humans and the environment.

Possible deleterious effects resulting from the release of GMOs during experimentation or commercialization are evaluated at the same time that monitoring measures are established to detect adverse conditions as well as to mitigate undesirable impacts.

There are several steps to be accomplished before the product can be legally commercialized. The first requires that the institution or company have a Biosafety Quality Certificate (CQB) [Certificado de Qualidade em Biossegurança], which attests to its competence, responsibility and fitness. Later, the National Technical Commission on Biosafety (CTNBio) [Comissão Técnica Nacional de Biossegurança] must review and approve research projects in confinement planned environmental releases in Brazil, in a controlled manner, to measure possible risks.

Information on each trait specific to the GMO – such as the inserted gene, the reproductive traits of the species, the soil and climatic conditions where the GMO will be released, the possibility of gene transfer, and the stability of the construct, among others – is required from the interested party, so that CTNBio can deliver a conclusive finding on the safety of the GMO.

Biosafety is the state, quality or condition of biological safety of life and health of humans, animals and plants, as well as the environment, without ranking the protection from risks associated with genetically modified organisms.

The balance between occupational, educational, social, informational, regulatory, organizational and technological components generates the “biosafety status,” which is simply the harmony between man, work processes, the institution and society (COSTA, 1998).

Technological developments, scientific progress and legal rigor have been contributing to the reduction of systematic laboratory accidents. Thus, it is responsibility of CTNBio “to issue, at the request of the applicant, the Biosafety Quality Certificate (CQB) related to facilities used for any activity or project involving GMOs or their derived products” (COSTA, 1998).

The Biosafety Act and Regulatory Ruling (IN) [Instrução Normativa] No. 8 expressly forbid, in activities involving humans, genetic manipulation of germ cells or totipotent cells, as well as radical cloning experiments. Only proposals involving somatic cells without germinative power will be considered for intervention or genetic manipulation in humans (VARGAS, 1997).

Meanwhile, according to the law, food products whose ingredients are derived from GMOs are the responsibility of the Ministry of Health, because they involve issues of human health and food safety.

Brazilian legislation on GMOs: Law No. 11,105

In March 2005 the President of the Republic signed Law No. 11,105 establishing safety standards and supervisory mechanisms for activities involving GMOs and their derived products, and other measures. This new legislation, whose discussion began in October 2003, replaces Law No. 8,974/1995 and other laws that currently regulate activities involving genetically modified organisms and their products in Brazil.

Law No. 11,105, dated March 24, 2005, known as the Biosafety Law, establishes a set of rules and procedures that must be adhered to for the development, importation, use and marketing of GMOs, as well as the issuing of authorization for entry into the country of these products and their derived products, within the competence of the Ministry.

For purposes of the new Biosafety Law, “research activity” is that which is performed in the laboratory, containment system, or field, as part of the process of obtaining GMOs and their derived products or for biosafety assessment of GMOs and their derived products, which includes, at the experimental level, the construction, cultivation, handling, transportation, transfer, import, export, storage, environmental release and disposal of GMOs and their derived products (§ 1 of Article 1).

The rule that only entities of public or private law may develop activities involving GMOs and their derived products still applies, forbidding autonomous individuals from independently performing such activities.

To carry out any research on GMOs and their derived products, authorization from CTNBio is required, which currently provides this through the issuance of the Biosafety Quality Certificate (CQB) (Regulatory Ruling (IN) [Instrução Normativa] No. 1, CTNBio).

This law also requires the creation of an Internal Biosafety Commission (CIBio) for all institutions wishing to develop activities involving GMOs or their derived products, similar to the current legislation, as already mentioned.

According to the text adopted by the National Congress, all members of CTNBio now must have a doctoral degree and professional activity in the areas of biosafety, biotechnology, biology, human and animal health or the environment. These requirements, established by Law No. 8,974/95, were previously restricted to members of CTNBio who were scientists.

Each member of CTNBio has an alternate, who shall work in the absence of the member, and, as such, shall be entitled to vote. The meetings of the Committee shall be convened with fourteen members, and decisions are taken by a majority of members present at the meeting.

So, if fourteen members are present, a project can be approved with eight votes, even though CTNBio is effectively composed of 27 members. It is hoped that this situation will never occur, considering the importance of the issues at hand. CTNBio members should therefore make every effort to attend all meetings and, if prevented, should be represented by their alternates.

A novelty of the new legislation is that CTNBio provides for charging a fee to pay the costs of assessing applications for authorization of research or commercial release of GMOs, to be defined in the Regulation of Law (§ 2 of Article 12).

The responsibilities of CTNBio include establishing regulations for research involving GMOs and their products in Brazil, and authorizing, registering and monitoring these activities.

The crucial point is in paragraph XX of Article 14, which states that CTNBio is responsible for identifying activities and products resulting from the use of GMOs and their derived products which could potentially cause degradation of the environment or cause risks to human health.

This analysis will continue to be made on a case-by-case basis, and only if CTNBio decides that a GMO or its derived product is a potential polluter shall environmental agencies be responsible for performing environmental licensing. In other words, Resolution No. 305/2002 shall be applied only to those GMOs or derived products which CTNBio decides are potentially polluting; in the case of research, it shall be required to obtain a Research Area Operating License (LOAP) [Licença de Operação para Área de Pesquisa] prior to release in the field.

The provisions of item XX of Article 14 are reinforced by § 2 of Article 16 of the new law, which instructs that environmental legislation shall apply only where CTNBio decides that the GMO is a potential cause of significant environmental degradation. Article 37 of Law No. 11,105 amends the description of Annex VIII of Law No. 6,938/1981, added by Law No. 10,165/2000, considering potentially polluting activities only to be the introduction of genetically modified species and the use of biological diversity by biotechnology in actions previously identified by CTNBio as potentially causing significant environmental degradation.

It also confirms § 3 of article 16: “CTNBio deliberates, in the last and final instance, on cases in which the activity is potentially or actually causing environmental degradation, as well as on the need for environmental licensing.”

The finding of CTNBio is binding on the other bodies of the Administration and § 3 of Article 14 provides that in case of a favorable technical decision on biosafety within the research activity, CTNBio shall refer the case to the supervisory bodies and entities of the Ministry of Environment, Health and Agriculture and the Special Ministry of Aquaculture and Fisheries, for them to exercise their duties. This means that the case should be directed to these bodies only in order for them to perform their inspection functions (Item I of Article 16).

Another great victory for research is the end of the requirement for Special Temporary Registration (RET) [Registro Especial Temporário] for genetically modified organisms considered related to pesticides. In fact, Article 39 ends the application of Law No. 7,802/1989 (Pesticides Act) to GMOs and their derived products, except when they are developed to serve as a raw material in the production of pesticides. In such cases, the requirements remain in place for obtaining RET.

Law No. 11,105 establishes the Biosafety Information System (SIB) [Sistema de Informações em Biossegurança] for the management of information arising from the activities of analysis, authorization, registration, monitoring and tracking of activities involving GMOs and their derived products, in order to provide greater transparency and openness in the activities performed by agencies involved in the matter. The data input into the SIB shall be obtained from registration and supervision agencies and entities.

Fines ranging from R$ 2,000 to R$ 1,500,000 are provided for institutions that do not comply with the provisions contained in the new legislation, to be enforced by the supervisory bodies.

Law No. 11,105 also makes it a crime to release or dispose of GMOs in the environment, as well as producing, storing, transporting, commercializing, importing or exporting GMOs or their derived products in non-compliance with the regulations established by CTNBio and by supervisory and registration agencies.

With the publication of the new law it will also become a crime to use, sell, register, patent and license Genetic Use Restriction Technologies (GURTs), which are technologies that induce sterility of seeds. The law, by not clarifying whether it is not considered a crime to do research on those technologies, creates a conflict for researchers, because it makes no sense to research a product whose use, marketing or patenting constitutes a crime.

Law No. 11,105 establishes the National Biosafety Council (CNBS) [Conselho Nacional de Biossegurança], made up of 11 state ministers and reporting to the office of the President of Brazil. The CNBS is responsible for formulating and implementing the National Biosafety Policy, limiting itself, however, to deciding issues regarding the commercial sale of GMOs and their derived products. In the case of research, decisions of CTNBio are final.

With regard to Roundup Ready soybeans, Article 30 of the Interim Provisions of that law states that soybean can be registered and commercialized from the date when the law comes into effect, considering that it has already been approved by CTNBio. However, the CNBS may decide against marketing within 60 days after publication of the law. Article 34 also validates the temporary registration of transgenic soybean plant varieties made with the National Plant Varieties Protection Service (SNPC). Embrapa has 11 plant varieties in this situation.

All Biosafety Quality Certificates, communications and technical decisions of CTNBio remain in force.

Finally, Article 38 of Law No. 11,105 establishes the obligation of the Executive branch to adopt administrative measures in order to expand the operational capacity of CTNBio and the agencies and entities for registering, authorizing, licensing and monitoring GMOs and derived products, as well training human resources in the area of biosafety.

National Technical Commission on Biosafety (CTNBio)

The National Technical Commission on Biosafety (CTNBio) is an agency within the Ministry of Science and Technology, responsible for regulation and release of GMOs in Brazil. Its mission is to authorize the development of research and of genetically modified organisms (GMOs).

The Biosafety Law establishes that research, production, import, traffic and marketing of GMOs depend on authorization by government authority. It is the responsibility of the Ministry of Agriculture, Livestock and Supply (MAPA), through its Plant Traffic and Quarantine Control Division [Divisão de Controle do Trânsito e Quarentena Vegetal], to supervise and monitor all activities and projects related to GMOs and their derived products.

Under Law No. 11,105, CTNBio remains under the Ministry of Science and Technology, but its composition will change from the current 18 members to 27. Of these, 12 are scientists, nine are representatives of ministries involved with the issue, one is a consumer protection specialist, one is a healthcare specialist, one is an environmental specialist, one is a biotechnology specialist, one is a family farming specialist, and one is an occupational health specialist.

Law No. 11,105 dated March 24, 2005 (published in Brazil’s Federal Official Gazette [Diário Oficial da União (D.O.U.)] dated March 28, 2005), regulates items II and V of paragraph 1 of Article 225 of the Federal Constitution, establishing standards for the use of genetic engineering techniques and environmental release of genetically modified organisms, and authorizing the Executive branch to create, under the office of Brazil’s President, the National Technical Commission on Biosafety (CNTBio) [Comissão Técnica Nacional de Biossegurança] (Biosafety Notebooks 1). Provisional Measure No. 2,137, published in Brazil’s Federal Official Gazette dated December 29, 2000, and later, Provisional Measure No. 2,191-8 dated August 23, 2001, make clear the responsibilities of the agency and the ministries involved in overseeing GMOs. Before the Provisional Measure, there were doubts as to the legal existence of CTNBio, whose activities were challenged in court. The claim was that the Commission had been created by decree and was not present in the Biosafety Law (source: MCT, Biotechnology Science and Development site, January 2002).

Internal Biosafety Commissions (CIBio)

Every institution that uses genetic engineering techniques or manipulates, transports, produces or plans to release GMOs into the environment must have an Internal Biosafety Commission (CIBio).

The CIBio must be appointed by the legal guardian of the entity. The entity must recognize the legal authority of the CIBio and provide support for the fulfillment of its duties.

Its responsibilities include monitoring and supervision of work with GMOs and ensuring compliance with biosafety regulations.

The composition of the CIBio should include people with experience to advise on, evaluate and supervise work with GMOs. It should be composed of at least three experts in areas compatible with the organization’s activities. The President of the CIBio shall be appointed by the legal guardian of the entity.

The responsibilities of the CIBio include (Article 10):

The institution’s main researcher is responsible for guaranteeing good biosafety practices, including the following:

Biosafety Quality Certificate (CQB)

CTNBio is the agency which issues the Biosafety Quality Certificate (Regulatory Ruling (IN) [Instrução Normativa] No. 1). The application is made by the interested CIBio, which forwards the application to the Commission and sends the required documents to the legal entity, i.e., name and address of the entity legally responsible for the operating unit, person responsible for the entity, person legally responsible for the operating unit, organizational chart of the operating unit, financial capacity (certificate of absence of unpaid obligations, issued by a notary). In 30 days, CTNBio issues its decision.

In the country, the following must apply for a CQB: national or international organizations developing projects related to GMOs and/or derived products; organizations engaged in technology research and development, and in production or provision of services involving GMOs and/or derived products.

The CIBio must notify CTNBio of any kind of change from what was approved. The CQB may or may not be maintained, depending on the changes. CTNBio, together with the supervisory bodies of the ministries, shall perform annual inspections, maintaining or revoking the CQB (Regulatory Ruling (IN) No. 1).

After applying for the CQB, if it is necessary to submit new documents, the applicant has 90 days to provide them, under penalty of termination of proceedings (Regulatory Ruling (IN) No. 14).

Financial organizations, public and private, national or international, which are interested in funding work with GMOs, by contract or agreement, must require the entity receiving the funding to show the CQB. Failure to comply with this requirement makes them co-responsible for any possible problems.

Biosafety legislation

Brazil has chosen a regulatory model for recombinant DNA technology which provides analysis on a case-by-case basis of individual GMOs before research or environmental releases are performed, to prevent possible risks.

The procedures adopted by CTNBio are internationally recommended and followed by countries that already have been using this technology for over 5 years. The CTNBio has produced twenty Regulatory Rulings (IN) [Instruções Normativas], in order to regulate the procedures to be followed in Brazil so that activities with GMOs can be performed safely (ODA, 2001).

Article 1 establishes safety standards and inspection mechanisms for the use of genetic engineering techniques in construction, cultivation, handling, circulation, marketing, consumption, release, and disposal of GMOs, to protect the life and health of people, animals and plants, as well as the environment.

In order to facilitate understanding and analysis of the material under study, Article 3 (IV) defines a Genetically Modified Organism (GMO) as an organism whose genetic material (DNA/RNA) has been modified by any genetic engineering technique. This law does not apply when the genetic modification is obtained through the following techniques: mutagenesis, formation and use of somatic animal hybridoma, cell fusion, including that of protoplasm, of plant cells, which can be produced by traditional breeding methods; and naturally processed self-cloning of non-pathogenic organisms (Article 4).

Classification of GMOs by risk

Regarding risk, GMOs are classified according to their pathogenicity, since biosafety levels are defined on this basis, i.e. the conditions under which the material can be worked with in order to ensure the state of safety, for either the researcher or the environment.

GMOs which are non-pathogenic are considered to be in Group I, risk class 1. GMOs resulting from a recipient or parental classified as pathogenic, from risk classes 2, 3 and 4, are considered to be in Group II (Annex II – Regulatory Ruling (IN) [Instrução Normativa] No. 1) .

The following GMOs are classified as being in Group I:

  1. Non-pathogenic recipient or parental organism, free of adventitious agents, with a history of safe use or with biological barriers, which, without interfering with optimal growth in the reactor or fermentor, has limited growth, without negative effects on the environment.
  2. Vectors or inserts: they must be well characterized, especially regarding risks to humans and the environment; their size should be limited to sequences of interest; they should not increase the stability of GMOs in the environment; they should not be mobilizable; they should not transmit resistance.
  3. Microorganisms: non-pathogenic, which offer the same safety as the recipient or parental organism in the reactor or fermentor, but with limited survival and/or multiplication, without negative effects on the environment.
  4. Other organisms that: have the conditions in paragraph c, based on a single prokaryotic donor (including plasmids and endogenous viruses) or from a single eukaryotic donor (including chloroplasts, mitochondria, plasmids); organisms composed entirely of gene sequences from different species, but which alter them by known physiological processes.

GMOs from Group II are all those which are not included in Group I.

Risk class is understood as the degree of risk associated with the recipient or parental (host) organism. It depends on the risk class of the vector, of the insert, of the receiver and of the resulting GMO. The categories are classified into four levels:

Based on the risk classes, the Biosafety Level (NB) [Nível de Biossegurança] is defined, i.e., the level of containment necessary to ensure safe work with GMOs.

For laboratories with Biosafety Level 1 (NB 1), the required practices are as follows:

For laboratories with Biosafety Level 2 (NB 2), the following practices are required:

For laboratories with Biosafety Level 3 (NB 3), the following practices are required:

Manipulation of human cells

The manipulation of human germ cells, as well as intervention in human genetic material in vivo, except for the treatment of genetic defects, are prohibited in Article 8. This article also prohibits the production, storage or handling of human embryos to be used as available biological material.

Thus, according to Article 13, it is a crime to do genetic manipulation of human cells and to manipulate human genetic material in vivo.

Commercialization and industrialization of GMOs

Products containing GMOs intended for commercialization or industrialization, from other countries, may only be released in Brazil subsequent to a conclusive finding by CTNBio and authorization from the Council of Ministers (National Biosafety Council (CNBS) [Conselho Nacional de Biossegurança] – under Draft Law (PL) [Projeto de Lei] 2,401-3).

Biosafety legislation, CTNBio and the environment

Constitutional aspects and legislative power regarding environmental issues and genetically modified organisms are under the jurisdiction of Brazil’s federal government.

Article 24, sections VI and XII of the Federal Constitution established the concurrent legislative power of federal and state governments in relation to the environment and public health.

The Specific Sectoral Committee on Environment, which comprises CTNBio, has jurisdiction in relation to environmental protection regarding the issue of genetically modified organisms.

The requirement for an Environmental Impact Study / Environmental Impact Report (EIA/RIMA) [Estudo de Impacto Ambiental / Relatório de Impacto Ambiental] for activities with significant potential for environmental degradation is presented in Article 225, paragraph 1, item IV of the Federal Constitution and Article 1 of Resolution No. 01/86, from the National Environmental Council (CONAMA) [Conselho Nacional do Meio Ambiente]. Considering activities with GMOs, Regulatory Ruling (IN) [Instrução Normativa] No. 3 from CTNBio and Provisional Measure No. 2,191-9 (Article 1 d) state that this Commission is responsible for identifying activities with significant polluting potential, which must be followed by inspection by the Brazilian Institute of Environment and Renewable Natural Resources (IBAMA) [Instituto Brasileiro do Meio Ambiente e dos Recursos Naturais Renováveis] to continue the process.

Law on access to genetic resources

From the United Nations Conference on Environment and Development (UNCED), held in June 1992 in Rio de Janeiro, a consensus has been emerging among governments around the world regarding the need to combine the conservation of biological diversity with need of States to implement mechanisms to ensure their sovereignty over genetic resources within their territory.

In this context, Brazil, along with 170 other countries, signed the Convention on Biological Diversity (CBD), whose fundamental principles are: promoting conservation of biodiversity, sustainable use of its components and equitable sharing of benefits arising from the use of genetic resources.

After signing the CBD in 1992, Brazil began a far-reaching debate, initiated by then Senator Marina Silva (current Minister of Environment), from the Labor Party (PT) [Partido do Trabalhador] of Acre State (AC), in order for Congress, in addition to ratifying the CBD, to transform it into a federal law, so as to establish mechanisms to protect and regulate forms of access to genetic resources and the knowledge associated with them, taking into account national peculiarities (LIMA, 1998).

On January 3, 1994, the CBD was ratified by Congress through Legislative Decree No. 02, and in 1995 Draft Law No. 306 was introduced by then Senator Marina Silva. This draft law was approved by the Senate in October 1998.

In 1996, the federal government established the Interministerial Group on Access to Genetic Resources [Grupo Interministerial de Acesso aos Recursos Genéticos]. This group aimed to discuss and present a national strategy for the use of genetic resources and present a new Draft Law (PL) to regulate the issue. The Draft Law was brought to Brazil’s House of Representatives in August 1998, as No. 4,751/98.

In 1998, Representative Jaques Wagner, Labor Party (PT) representative from Bahia State, introduced Draft Law No. 4,579/98, based on the Draft Law of Senator Marina Silva, incorporating some innovations and suggestions submitted by NGOs and social movements regarding the issue of sustainable agriculture and the rights of indigenous and traditional peoples (LIMA, 1998).

Law on access to genetic heritage – Provisional Measure No. 2,186-16

Provisional Measure No. 2,186-16 dated August 23, 2001 (re-issue of Provisional Measure No. 2,052-2 dated July 26, 2001), regulates the Convention on Biological Diversity, providing for access to genetic resources, protection and access to associated traditional knowledge, sharing of benefits, access to technology and technology transfer for its conservation.

Decree No. 3,945 dated September 28, 2001, and Decree No. 4,946 dated December 31, 2003, repealing and amending some articles of the first decree (Articles 8, 9 and 12), define the composition of the Genetic Heritage Management Council [Conselho de Gestão do Patrimônio Genético] and establish rules for its operation.

Provisional Measure No. 2,186-16 provides owners and holders of property and rights fair and equitable sharing of benefits arising from access to genetic resources and traditional knowledge (Article 1, § 2).

According to Article 2 (single paragraph), the genetic heritage and natural resources found on the continental shelf and in the exclusive economic zone are the property of the federal government of Brazil and thus only it may authorize their exploitation.

In Article 7, certain concepts are defined for better understanding of that Provisional Measure:

have the source of access to the traditional knowledge indicated in all publications, uses, exploitation and disclosures;

prevent unauthorized third parties from using, testing, researching or exploiting anything relating to the associated traditional knowledge;

prevent unauthorized third parties from disclosing, transmitting or retransmitting data or information comprising or constituting the associated traditional knowledge;

receive benefits, compensation or royalties for economic exploitation by third parties, directly or indirectly, of associated traditional knowledge to which the local or indigenous community owns the rights.

A major opportunity for national research is presented in Article 22 (“From access to technology transfer”), which requires local partnership between companies and foreign institutions wishing to exploit Brazil’s biodiversity.

Article 30 of this Provisional Measure provides certain sanctions for an administrative violation against genetic heritage or the associated traditional knowledge, which range from warnings to fines of up to BRL 50,000,000 (fifty million reais), as determined by the competent authority according to the infraction.

Article 31 provides that all funds obtained from the exploitation of processes and products developed from samples of genetic heritage components (profits, royalties, fines) will be for the National Environmental Fund [Fundo Nacional do Meio Ambiente] (created by Law No. 7,797 dated July 10, 1989), the Naval Fund [Fundo Naval] (created by Decree No. 20,923 dated January 8, 1932) and the National Fund for Scientific and Technological Development [Fundo Nacional de Desenvolvimento Científico e Tecnológico] (established by Decree-Law No. 719 dated 31 July 1969, and restored by Law No. 8,172 dated January 18, 1991).

Article 10 provides for the creation of a Genetic Heritage Management Council [Conselho de Gestão do Patrimônio Genético], composed of representatives from agencies having legal jurisdiction over several issues dealt with by the Provisional Measure. Its powers include: granting authorization for access to associated traditional knowledge, upon prior consent of its owners; and supervising the activities of access to samples and shipment of samples of genetic heritage components to an applicant institution. To enable access to the sample, Article 13 provides for the signing of a Contract for Use of Genetic Heritage and Benefit-Sharing [Contrato de Utilização do Patrimônio Genético e de Repartição de Benefícios]. Decree No. 3,945 dated September 28, 2001 defines the composition and duties of the Genetic Heritage Management Council.

Decree No. 4,946 dated December 31, 2003, amends, repeals and adds provisions to Decree No. 3,945, which regulates Provisional Measure No. 2,186-16. This decree establishes certain duties of the Genetic Heritage Management Council regarding the requirement of documents from applicant institutions for access to genetic resources, traditional knowledge and associated technology transfer.

Genetically modified products (GMPs)

Among important issues pertaining to human health, CTNBio evaluates potential problems related to traits of allergenic proteins expressed by the transgene. It is essential to ensure that no product containing allergenic proteins not found in the conventional product be released for human consumption (ODA, 2001). Another important aspect is the absence of substances which are toxic or which might cause damage to the body or have undesirable interactions with other elements.

It is also important to maintain the nutritional characteristics of food. The use of a genetically modified food should not introduce any variables that might adversely affect human health; on the contrary, in modern times, the development of foods that have improved nutritional characteristics is being encouraged, in order to reduce heart disease, or to provide greater vitamin content.

Safety of genetically modified foods

The use of certain biotechnology allows the food industry to increase productivity and reduce costs, especially by improving the quality of certain products. Thus, thorough assessment of the safety of these products is already clearly established throughout the world. Products approved for commercial sale are those considered safe for consumption.

Procedures for assessing the food safety have been discussed in a consistent and consensual manner among world experts, in the Codex Alimentarius (FAO / WHO).

Food safety is the assurance that food will not cause any damage to the health of the consumer when prepared and/or eaten according to its intended use (WORLD HEALTH ORGANIZATION, 1996, cited by YOKOYAMA, 2001).

Food safety is based on the principle of risk assessment. This procedure consists of four phases:

Thus, risk is a direct function of hazard and probability (risk = hazard x probability). The risk depends on the level of exposure to the hazard; the existence of the hazard does not, in itself, entail appreciable risk (YOKOYAMA, 2001).

Hazard is understood as a biological, chemical or physical agent present in food, or a condition of the food with the potential to cause adverse health effects.

Risk, in turn, is assessed in accordance with the probability of causing an adverse health effect, and the severity of that effect occurring as a consequence of the hazard (WORLD HEALTH ORGANIZATION, 1996, cited by YOKOYAMA, 2001).

Food safety assessment is required whenever changes are made in the process by which food is obtained, or a new process is introduced. The scope of the assessment will depend on the nature of the observed or perceived hazards (WORLD HEALTH ORGANIZATION, 1991, cited by YOKOYAMA, 2001).

Some elements are common to the assessment of safety of foods and GMOs. They are:

The safety assessment of genetically modified products occurs in three phases (YOKOYAMA, 2001):

Phase 1 – Safety of the gene, protein or plant:

Phase 2 – Biological/agronomical equivalence:

Phase 3 – Detailed product safety:

The scheme to be followed in order to assess food safety has two different focuses. First, clarification of issues relating to the gene and the protein, and then questions intended to check whether the product meets the requirements for substantial equivalence.

Regarding the genetic nature of the insertion, the following should be clarified: the sources, the molecular characterization of the insertion, the number of copies and the integrity of the gene.

Regarding the protein, the following are researched: history of safe use, function, specificity and the mode of action, expression levels, and special attention is given to issues relating to toxicology and allergenicity. In this case, attempts are made identify the sequence of amino acids, digestibility, acute oral toxicity, among other studies.

To clarify issues of substantial equivalence, attempts are made to identify the characteristics (morphological and agronomical) and composition of the food or animal feed (analysis of its composition, nutrients, antinutrients, specific animal development trials).

The methodology for the safety assessment of foods derived from genetically modified plants has been adopted consistently throughout the world. Among the world’s scientific and technical organizations cited by Yokoyama (2001) are:

Authorities and international regulatory agencies include:

Regulatory Ruling No. 20 – Safety assessment of genetically modified foods

Regulatory Ruling (IN) [Instrução Normativa] 20 dated December 11, 2001, approved by CTNBio (COMISSÃO TÉCNICA NACIONAL DE BIOSSEGURANÇA, 2002), establishes standards for food safety assessment of genetically modified plants or their parts.

According to information from members of CTNBio, the document was drafted to address the court ruling, in the Public Civil Action filed by Brazil’s Institute for Consumer Defense (IDEC) [Instituto de Defesa do Consumidor] and Greenpeace, which states that no genetically modified organism may be released or commercialized in Brazil until CTNBio publishes regulations regarding food safety and labelling of GMOs for human and animal consumption (BOLETIM AS-PTA, 2002 cited by COMISSÃO TÉCNICA NACIONAL DE BIOSSEGURANÇA, 2002).

The Regulatory Ruling was formulated as a questionnaire that aims to answer questions pertaining to the donor organism, the recipient plant, the protein expressed, nutritional quality, allergenicity, among other adverse effects.

The main concerns within each of the topics are as follows:

  1. Donor: traits of allergenicity and/or toxicity.
  2. Recipient: whether the plant is already used as food and traits of allergenicity and/or toxicity.
  3. Protein expressed: whether the level of protein expressed by the transgene is comparable to its content in the donor organism or other food, and whether its biological function presents a risk factor for human or animal health.
  4. Nutritional quality: whether the chemical composition and nutritional value of the food derived from the genetically modified plant, in natura or after processing, is different from the conventional (plant without modification).
  5. Allergenicity: whether there is similarity between the primary structure of the components of the genetically modified plant and known allergens, and immunochemical affinity of the protein specified by the transgene for IgE antibodies in the serum of allergic individuals.
  6. Adverse effects: whether the genetically modified plant produces metabolites that may cause adverse effects to human and animal health, and whether there is evidence of horizontal transfer of the transgene into the genome of humans or animals.

In summary, according to Regulatory Ruling 3, if CTNBio considers that release will cause negative effects on the environment, the application is sent to the Ministry of the Environment, which may require the preparation of an Environmental Impact Study / Environmental Impact Report (EIA/RIMA) [Estudo de Impacto Ambiental / Relatório de Impacto Ambiental] for release of GMOs. Some weak points of Regulatory Ruling (IN) No. 20 have been raised by environmentalists, such as the fact that it only refers to modified plants, disregarding genetically modified animals and, therefore, mixed foods, such as those containing plant and animal ingredients (BOLETIM AS-PTA, 2002, cited by COMISSÃO TÉCNICA NACIONAL DE BIOSSEGURANÇA, 2002).

Labelling of genetically modified foods

Labelling is beyond the powers of CTNBio, being within the scope of the Consumer Protection Code [Código de Defesa do Consumidor]. The labelling of a product is the main channel of communication with the consumer, so it should convey correct information about the nutritional characteristics and composition of the product, allowing a free choice by the consumer. In order for the food to be offered for consumption, it must first of all be safe and provide the required quality. Therefore, the role of CTNBio precedes labelling, because if a GMO is not considered safe, it can never be used for consumption.

Labelling around the world

United States

The FDA’s Statement of Policy on Foods Derived from New Plant Varieties (FDA 1992/96) provides for:

After approval for human consumption:

Europe

Regulation No. 258/97 of the Parliament/Council of the European Community, which deals with “regulation of novel foods and food ingredients,” provides:

Regulation No. 1,139/98 of the Council of the European Community, which deals with “regulation on the labelling of certain foods derived from GMOs,” applies only to products based on or derived from corn and soybean.

It describes:

European Community Regulation No. 49/2000 amends Regulation No. 1,139/98, which:

Regulation No. 50/2000, which deals with “labelling of foods containing additives and flavorings genetically modified or produced from GMOs,” provides:

Switzerland

The local regulation established in 1999 provides:

Australia and New Zealand

ANZFSC – Standard A18 (1998) provides a “standard for foods produced using gene technology,” which:

Some expressions have been proposed in public consultation:

Japan

In Japan, food is evaluated by a committee of 18 experts and approved by the Ministry of Health.

The rule for labelling was discussed between May 1997 and April 2000, by an Advisory Committee for Food Labelling, which:

Three categories for labelling have been defined:

Russia

In Russia, the labelling rule, dated July 2000, establishes:

Labelling of genetically modified foods in Brazil

Environmental release of any GMO for cultivation or for human or animal consumption depends on receiving a technical opinion from CTNBio (Law No. 8,974/95 and Decree No. 1,752/95 – still in force until the date of approval of Draft Law (PL) No. 2,401-03, of February 2004, passed the House of Representatives and now before the Senate).

Decree No. 4,680 dated April 24, 2003 regulates the right to information, provided by Law No. 8,078 dated September 11, 1990, concerning food and food ingredients intended for human consumption or animal feed, containing or produced from genetically modified organisms. This Decree repeals Decree No. 3,871 dated July 18, 2001.

According to Article 2 of this decree, the consumer must be informed, as part of the commercialization of foods and food ingredients intended for human or animal consumption, that they contain or are produced from genetically modified organisms, which are present above the 1% limit. Paragraph 1 subsequently states: “both on packaged goods sold in bulk to or in natura, the label of the container or package (...) must clearly display one of the following expressions, depending on the case: genetically modified (product name); contains genetically modified (name of the ingredient or ingredients); or product produced from genetically modified (product name).” In addition to this information, consumers must also be provided data on the gene donor species, in the place reserved for the identification of ingredients (§ 2). This information must be included in the tax document, i.e., it must accompany the product or ingredient in all stages of production (§ 3).

Foods and food ingredients produced from animals fed with feed containing genetically modified ingredients are also subject to labelling. They must clearly show, “(name of the animal) fed diets containing genetically modified ingredients,” or “(name of ingredient) produced from animals fed diets containing genetically modified ingredients” (Article 3). Foods and food ingredients not containing or produced from genetically modified organisms may optionally use the labelling “(product name or ingredient) free of genetically modified products” provided that there are similar, genetically modified products on the Brazilian market, according to Article 4.

Ordinance No. 2,658 dated December 22, 2003 defines the symbol designating the labelling mentioned in Decree No. 4,680. It was to have entered into force after 60 days, but Ordinance No. 786 dated February 26, 2004, extended its implementation for another 30 days. This will be enforced in a manner complementary to the provisions of the Technical Regulation for Labelling of Packaged Foods, approved by Resolution No. 259 dated September 20, 2002 from Brazil’s National Health Surveillance Agency (ANVISA) [Agência Nacional de Vigilância Sanitária], which is intended to define the shape and minimum dimensions of the symbol which will be included on packaging of foods containing or produced from genetically modified organisms.

According to this ordinance, the symbol must appear on the main panel, clearly displayed and using contrasting colors in order to ensure proper visibility, consisting of a triangle, which shall contain the capital letter T, as follows:

Biodiversity

Concept

Biological diversity and biodiversity include expressions that refer to the variety of life on the planet, or the property of living systems being distinct.

Biodiversity is one of the fundamental properties of nature and the basis for agricultural, livestock, fisheries and forestry activities and also the basis for the biotechnology industry.

According to Edward Wilson, cited by Dias (1998), the number of species of organisms used to be more than 5 million, while recent studies acknowledge a range of 10 to 100 million species. The number of known species is 1.7 million.

Brazil contains 15% to 20% of the total species on the planet (DIAS, 1998). It has the most diverse flora in the world (55,000 described species, or 22% of world total). It has the largest richness of palm species (390 species) and orchids (2,300 species).

Brazil also still presents a high rate of endemism:

Sectors involved in the use of biodiversity and environmental biotechnology are emerging on the biotechnology scene in Brazil: in the first case, due to the need for screening of native plants, microorganisms and animals hoping to discover genomes, genes and molecules of economic value; and in the second case, due to the demand for bio-processing and utilization of industrial effluents and bioremediation. The two sectors are strategic for the country to establish sustainable development policies. These policies will determine competitiveness in the coming decades (EDGINGTON, 1995; MOREIRA FILHO, 1996).

The more immediate interest in the case of biodiversity comes from pharmaceuticals and agribusiness. One need only recall that the success rate in the discovery of pharmacologically active principles in plants is 1:125, versus 1:10,000 when screening compounds produced from chemical synthesis. Just as it was possible to discover genes that confer disease resistance in commercial varieties of plants, wild plants and microorganisms, it is also possible to “tame” plants for commercial applications (JESUS, 1999).

According to Abreu et al. (1998), agrobiodiversity is a critical component of global biodiversity, and since more than 75% of the world’s food is produced by just over 25 domestic plants and animals, handling and management of these genetic resources is essential for world food security. This fact encounters another great need: increasing productivity and sustainability of production systems. Thus, the identification of plant and animal germplasm, which are highly productive and adapted to ecological conditions, is a global priority, recognized by the United Nations Food and Agriculture Organization (FAO).

Environmental biotechnology involves not only methods of wastewater treatment and bioremediation (with great potential demand in Brazil), but also development of systems for industrial parks, where one industry can use waste from another, or remobilize related residues (MAY; MOTTA, 1994; EDGINGTON, 1995).

The major concern with environmental issues tends to make biological degradation of wastewater a more attractive alternative than natural and chemical methods, due to the fact that it accelerates the degradation process, and is cheaper and more acceptable than chemical methods.

In the case of cyanides, which are potentially toxic compounds to any kind of life – heavily used in the leaching of ores, chemical intermediates, pharmaceuticals (around 3 million tons per year) – biological degradation already uses living organisms such as bacteria, fungi and algae, which possess enzyme systems and specific metabolic pathways capable of metabolizing or transforming these toxic ions into products less harmful to the environment (LINARDI, 1998).

Biodiversity and trends

The increase of animal germplasm banks (AGB) is one of the major possibilities for exploitation of biodiversity. Besides being important to secure supplies of doses of semen and embryos of different races and/or domesticated animal species threatened with extinction (as Cenargen does), many possibilities arise from the freezing of oocytes for two reasons:

In this context, it is worth emphasizing the importance of genetic combinations capable of being produced from naturalized breeds, and a greater effort is imperative to mitigate the damage imposed by the rate of loss of animal genetic resources, in view of (ABREU et al. 1998):

Biodiversity products account for 31% of Brazilian exports (especially coffee, soy and orange). The agricultural industry accounts for about 40% of Brazilian GDP, the forestry sector, about 4%, and fishing, about 1% (PROBIO/SP..., 1999).

Through the Convention on Biological Diversity, after the Conference of Parties (COP – four held already), four work programs were created for: Maintenance of Marine and Coastal Biodiversity, Agrobiodiversity, Forest Biodiversity, and Biodiversity of Continental Waters. The Conference also created the Subsidiary Body on Scientific, Technical and Technological Advice (SBSTTA, the Clearing-House Mechanism) and the Financial Mechanism (Global Environment Facility).

National Environmental Policy

Law No. 6,938 dated August 31, 1981, known as the National Environmental Policy, introduced a conceptual difference that served as a watershed. No environmental damage is exempt from repair; strictly speaking, there is no tolerated emission of pollutant. The new legislation is based on the idea that polluting waste tolerated even by established standards can cause environmental damage and therefore subject the party causing the damage to payment of compensation. It is the concept of strict liability, or risk associated with the activity, according to which damage cannot be shared with the community.

The subtle difference lies in the situation where a company is meeting maximum legal pollution standards, and yet may still be held liable for residual damages caused. Thus, it is sufficient to prove a cause and effect link between the activity of a specific company and environmental damage. This is the essence of what is known as strict liability: in order for there to be an obligation to repair environmental damage, it is not necessary for it to have been produced as a result of an illegal act (not meeting the regulatory limits of tolerance, concentration or intensity of pollutants) because strict liability does not require proof of guilt. In short, it is sufficient that the production source has caused the damage, regardless of whether it met the standards prescribed for polluting emissions (MONTEIRO, 1999).

Federal Constitution

The Federal Constitution promulgated in October 1988 devoted an entire chapter to the environment (Chapter VI – The Environment; Title VIII – The Social Order) and, as a whole, contains 37 articles related to environmental law and five others related to urban law.

The Constitution established a number of obligations on public authorities, among which are: (i) the preservation and recovery of species and ecosystems; (ii) the preservation of the variety and integrity of genetic heritage, and supervision of entities engaged in genetic research and manipulation; (iii) environmental education at all school levels and public guidance on the need to preserve the environment; (iv) definition of territorial areas for special protection; and (v) requirement of environmental impact studies for the installation of any activity that may cause significant degradation of the ecological balance.

Criminal sanctions

Law No. 9,605 dated February 12, 1998, establishes criminal penalties applicable to activities harmful to the environment. The purpose of this law is to determine the criminal responsibility of the polluter or party degrading the environment, without any claim to waive Law No. 6,938/81, which regulates civil reparation arising from acts harmful to the environment. Article 2 of that law includes, among the parties subject to criminal prosecution, not those only directly responsible for the damage, but also other agents who were aware of the criminal conduct, and who failed to prevent it.

That law provides custodial sentences for individuals – arrest or imprisonment – as well as penalties restricting rights, established by Article 7, while Article 21 provides the application of fines – restriction of rights and provision of community services.

Provisional Measure No. 1,710-1

On September 8, 1998, Provisional Measure No. 1,710-1 was published, authorizing regional environmental enforcement agencies to enter into terms of engagement with individuals or business entities responsible for the construction, installation, and operation and expansion of activities considered to be actually or potentially polluting. These terms of engagement are designed to bring the activities of individuals and business entities into conformance with the environmental regulations in force, without the risk of imposition of administrative penalties provided for in Law No. 9,605 dated February 12, 1998, during this adjustment period.

National Environmental System

Several federal agencies for the effectiveness of environmental legislation have been instituted: the National Environmental System (SISNAMA) [Sistema Nacional do Meio Ambiente], a regulatory, advisory and deliberative body; the National Environmental Council (CONAMA) [Conselho Nacional do Meio Ambiente]; the Ministry of the Environment, Water Resources and the Legal Amazon (MMA) [Ministério do Meio Ambiente, dos Recursos Hídricos e da Amazônia Legal], the agency charged with coordinating, monitoring and control of the national environmental policy; and the Brazilian Institute of Environment and Renewable Natural Resources (IBAMA) [Instituto Brasileiro do Meio Ambiente e dos Recursos Naturais Renováveis], the executive body.

SISNAMA also includes other agencies of the federal administration, public foundations aimed at protecting the environment, entities of the Executive branch, and at the state and municipal levels (State and Municipal Departments of Environment; Environmental Agencies – CETESB / FEEMA / COPAM / IAP / CRA and others) in their respective jurisdictions.

São Paulo State Program for the Conservation of Biodiversity (Probio/SP)

The State of São Paulo has a specific program for biodiversity within the State Secretariat for the Environment.

The State Program for the Conservation of Biodiversity (Probio/SP) [Programa Estadual para Conservação da Biodiversidade] (PROBIO/SP..., 1999) aims to deploy, in São Paulo State, the Convention on Biological Diversity (CBD), the official international steering document that addresses this issue.

The main objectives of the CBD are: conservation of biodiversity, sustainable use of its components and fair and equitable distribution of the resources arising from such use. These are also the goals of Probio/SP, in addition to the goal of appreciating social diversity.

Genetically modified plants

Regulations for the import of genetically modified plants (GM plants)

These regulations are referred to in Regulatory Ruling No. 2 from CTNBio.

The authorization for introducing GM plants and their parts into the country, represented by small amounts or samples of seeds, live plants, fruits, cuttings, buds, bulbs, tubers, rhizomes, in vitro plants, requires an import permit.

This request must be made to the Department of Plant Protection and Inspection (DDIV) [Departamento de Defesa e Inspeção Vegetal], of the Ministry of Agriculture, Livestock and Food Supply (MAPA) [Ministério da Agricultura, Pecuária e Abastecimento] after the technical finding by CTNBio. It is thus the responsibility of the DDIV to submit the application to the requirements contained in Decree No. 24,114 dated April 12, 1934, and Ordinance No. 148 dated 15 June 1992, from the Ministry of Agriculture, Livestock and Food Supply.

In any case, the material introduced can only be used under containment. The authorization does not allow the conduct of research in the field, which can only be authorized by a conclusive finding from CTNBio, under separate application, after examination of specific documents, in accordance with CTNBio regulations.

Planned environmental release of GMOs

According to Regulatory Ruling (IN) [Instrução Normativa] No. 3, each application filed by the proposing institution to the CIBio shall be reviewed by a Sector Specific Committee [Comissão Setorial Específica] of CTNBio, which may consult the advice of ad hoc consultants when deemed necessary. Generally, eight weeks are required between the receipt of an application and the initial considerations of the Commission. If CTNBio considers that the release will cause negative effects on the environment, it shall be submitted to the Ministry of the Environment, Water Resources and the Legal Amazon (MMA) [Ministério do Meio Ambiente, dos Recursos Hídricos e da Amazônia Legal], which may call for an Environmental Impact Study / Environmental Impact Report (EIA/RIMA) [Estudo de Impacto Ambiental / Relatório de Impacto Ambiental], in accordance with guidelines established in CONAMA Resolution No. 001/86, which could result in recommendations on conditions to be added to the response.

After CTNBio recognizes that a given planned release may proceed, the document of public information (submitted by the applicant) shall be published in Brazil’s Federal Official Gazette [Diário Oficial da União (D.O.U.)].

Progress of the release shall be monitored by the CIBio, following the protocol and objectives presented by the institution and approved by CTNBio.

During analysis, the impacts to be considered include effects on: health, public safety, agricultural production, other organizations, and environmental quality.

Analyses are performed on the basis of questionnaires submitted to the applicant. In addition to a core questionnaire, common to all types of GMOs, specific questionnaires are used.

The core questionnaire refers to the habitat and genetics of the GMO, data on work under containment and other studies on stability, survival, dissemination, as well as experimental procedures, monitoring and planning for biosafety.

The specific questionnaires have certain common concerns, such as:

Genetically modified plants

In the case of plants; the questionnaires reflect the main concerns regarding the following procedures: the ability of the GMO to be more competitive in comparison with conventional varieties (B9 and 10); the possibility of cross-pollination (B5); the ease of dispersion of seeds (B6); the possibility of introgression of the inserted gene (B8); the possibility of the modification involving increased toxicity of the plant (B10); and the possibility of risks to the environment (B10 and 11).

Genetically modified microorganisms living in association with animals

The focus of this study is the organisms that make up the intestinal flora of large hosts, or microorganisms externally applied on the skin of animals.

The main concerns that guide the analysis of genetically modified microorganisms (GMMs) living in association with animals are the following: competitive advantage conferred to the host (C4 and 5); interaction with other plants or animals (C6); introgression of the inserted gene into host cells or into other cells in the host (C7); dispersion into the environment (C8 and 9); and their control (C10) or resistance.

Genetically modified microorganisms as vaccines for veterinary use

The analysis to be done in the case of genetically modified organisms as live vaccines for veterinary use is directed towards: (a) durability of the vaccine organism in the recipients (D2); (b) dissemination of the vaccine organism to other, unvaccinated organisms (D3); (c) introgression of the vaccine material into host cells (D5); (d) fate of the vaccinated animals at the end of the trials (D7); and (e) effects of the vaccine in pregnant animals (D9). In addition, safety trials should be analyzed (D9) and the appropriate measures taken, especially in relation to the control, stability and disposal of the material (D11).

Genetically modified microorganisms applied to modify the physical or chemical environment

These microorganisms are those used for the correction of certain environmental factors adverse to the needs of farming, for example, microorganisms that modify the properties of the soil.

The analysis of these microorganisms covers assessing the effects of interaction of the GMO with the local biota (E3 and 7), as well as with associated plants or the environment (E8). It deals primarily with checking: (a) whether the GMO can affect the suitability of plants for human or animal consumption (E4); (b) its effects on soil chemistry (E5) and water quality (E6); (c) as a means of survival and dispersal of the GMO in water and soil (E6); (d) whether the GMO exchanges material with pathogens (E10); and (e) its control (E11).

Genetically modified vertebrate animals (excluding fish)

The main concern that guides the analysis of vertebrate animals refers to the effect that the expression of modified traits may have on behavior, physiology and reproduction of the animal (F2). The analysis also includes: measures for the management and containment of the progeny of experimental animals (F3); processes to be used to minimize the risks of releasing transgenic sequences potentially adverse to human and animal health (F3); possible expression of genetic material in feral animals (domesticated species to be reintegrated into nature – F4); and whether the GMO is able to cross with any native species (F6).

Genetically modified fish and aquatic organisms

For modified aquatic organisms, the analysis focuses mainly on: the question of the possibility of the organism spreading to another habitat (G5 and 9); the influences on regional farming and the environment (G8); and the integration of genetic material into other populations (G7).

Also of concern is the production of new toxins or metabolites that have an effect on parasites or predators (G1).

Invertebrates

The analysis for genetically modified invertebrates is mainly directed to the possibility of the modification affecting their distribution and natural abundance (H6) and the dispersal of the GMO to other environments (H7).

Organisms for biological control

In the analysis of organisms for biological control, the most obvious concern lies in: the direct effects of the GMO on the target species (J1); the spectrum of organisms susceptible (J2); the consequences of the reduction of the target species on the handling of plants and animals of interest to agriculture (J5); and the consequent change in the environment due to this reduction.

It is also important to evaluate the possibility of new genetic traits affecting non-target species (J7).

Organisms for bioremediation

The focus of the analysis of organisms for bioremediation is concentrated mainly on: substances that can be metabolized by the GMO and not by the parental (K2); whether the GMO produces metabolites that may have deleterious effects on other organisms (K4) and whether GMO can disperse from the application site (K7).

Organisms consumed as food

In the case of modified organisms intended for human consumption, the analysis focuses on testing the ability of the GMO to produce metabolites which may cause adverse effects to the consumer. For this purpose, it provides information regarding toxicology, allergic reactions and other adverse effects (L2); it indicates whether the nutritional quality of food could be altered by the introduced genetic modification (L3); and also whether the GMO is able to transfer transgenic sequences to the consumer (L5).

Chapter 3
Biosafety regulations in Paraguay (ALVAREZ, 2000)

Institutional responsibilities

The areas linked to the development of biotechnology are regulated by the following organizations:

Legal framework of regulation of GMOs

Paraguay does not have a specific law to regulate transgenic plants. The implications of the use of genetically modified materials are analyzed within the framework of the general laws of the country by applying the following laws: Law No. 253/93, which approves the Convention on Biological Diversity; Law No. 294/93 on Environmental Impact Assessment; Law No. 385/94 on Seeds and Plant Variety Protection; Law No. 123/91 on Plant Protection; Law No. 96/92 on Wildlife; Law No. 352/94 on Protected Wildlife Areas; Law No. 836/80 on the Sanitary Code, and Law No. 1,334/98 on Consumer and User Protection.

The Seeds Law62 regulates the introduction of exotic varieties. The National Seeds Council [Consejo Nacional de Semillas] is an important institution for understanding and addressing issues related to propagating material. This entity is comprised of representatives from the National Directorate of Plant Protection (DPV), the Directorate of Seeds (DISE), and the Directorate of Agricultural Research (DIA) [Dirección de Investigación Agrícola].

The Law on Plant Protection63 (Law No. 123 of 1991) provides for the Directorate of Plant Protection (DPV) to inspect, take samples, and carry out analyses of evidence of primary products of plant origin, of materials intended for propagation, transported, sold or offered for sale at any time and place, as well as to inspect shops, markets, fruit, ornamental and forest nurseries, and deposits of plant materials.

Process of supervision of release of GMOs

The Agriculture Biosafety Commission (CBA), which reports to the Ministry of Agriculture and Livestock (MAG) and the Ministry of Public Health and Welfare (MSPBS)64, is the body responsible for authorizing the introduction of GMOs into the country for agricultural use. The Commission aims to “... handle, consider and recommend all matters concerning introduction, field trials, research and environmental release of transgenic plants into the country,” and the ministries make decisions based on its findings.

Commission members are employees drawn from various dependencies of MAG involved in this issue, the Ministry of Public Health and Welfare, the Faculty of Agricultural Sciences at the University of Asunción, and members of Paraguay’s Rural Network of Private Organizations for Development [Red Rural de Organizaciones Privadas de Desarrollo] and Network of Environmental Organizations [Red de Organizaciones Ambientalistas].

Agents interested in producing this type of material in the country should fill out a form created for this purpose and submit it to the Technical Secretariat of the Commission, which works in the Directorate of Seeds (DISE) of MAG.

Experience in regulating GMOs

The regulatory framework for biosafety in Paraguay is based on the following laws: the Law on Seeds and Plant Variety Protection, the “Environmental Impact Assessment” Law65, the Law on “New Regulations for Plant Protection,” the “Ratification of the International Covenant Biological Diversity” Act66, the Decree on the “Creation of the Biosafety Commission”, and other regulations concerning the matter. Based on this legislation, Paraguay temporarily banned use for commercial purposes of any genetically modified material or organism.

From the beginning, the Commission considered the application for the introduction of Roundup Ready (RR) soybeans by Monsanto (LOVERA, 2000). While trials were being performed, MAG did not allow field trials of RR soybeans in the 1997-98 crop. In 1999, the Commission was against the introduction of RR soybeans, and MAG decided not to allow the planting of genetically modified material in Paraguayan territory. In the 1999-2000 season, the Biosafety Commission recommended and the Ministry of Agriculture and Livestock authorized experimentation with RR soybean seeds, in order to generate results that make it possible to know the agronomical traits of the new material in the agro-ecological conditions of the country.

The decree of the Commission found that there were numerous issues about environmental risks and human health, since the material had not been experimented with in the local environment, because the country lacks adequate resources and scientific personnel for such a task. MAG’s argument was based on rejection of transgenic products from Paraguay by major overseas markets. The environmental and commercial reasons reinforce the country’s application of the precautionary principle, adopted at Earth Summit 1992.

Some companies had also tried to get approval to introduce Argentinian Bt corn into the country, but the Commission has positioned itself against this. One of the arguments used was the frequent use of up to 3% of corn grain for reproductive purposes, putting the nation’s 14 most important domestic varieties at risk of contamination. This resolution was reconsidered and finally the entry of Bt corn was approved for the sole purpose of industrial processing.

In 1999, MAG Resolutions No. 554/99 and No. 82/99 established a temporary ban on commercial use of any genetically modified material or organism during the 1999-2000 season, a decision that was renewed in 2000-2001 season67. Under this regulation, the seeds/grains of transgenic soybeans harvested in the 1999-2000 season cannot be used as seeding material.

The resolutions call attention to the importance of the issue for the export of grain and industrial derivatives, which represent a high percentage of currency inflow into the country. It is also argued that Paraguay is a signatory to the precautionary principle, Principle 15 of Agenda 21, approved at the Earth Summit held in 1992 (ECO 92), and ratified by Law No. 253/93, which states: “In order to protect the environment, States should apply the precautionary approach widely, within their capabilities. Where there are threats of serious or irreversible damage, lack of full scientific certainty should not be used as a reason for postponing cost-effective measures to prevent environmental degradation” and “a regulatory framework is needed to ensure and guarantee the biosafety measures necessary to protect the potential of agro-ecosystems.”

National perspectives on the introduction of other mechanisms

Under the institutional aspect, a technical cooperation agreement was signed between MAG and the FAO. One of the outcomes was the development of a draft Law on Biosafety, which would have a more solid basis.

Chapter 4
Biosafety regulations in Uruguay

General features of the regulatory system

The regulatory system of Uruguay, in the main areas of biotechnology development, is composed of various governmental institutions. The Ministry of Livestock, Agriculture and Fisheries (MGAP) [Ministerio de Ganadería, Agricultura y Pesca] has jurisdiction over the agricultural sector, agrochemicals, seeds and in the veterinary field. Environmental issues are the responsibility of the Ministry of Housing, Environment and Land Use Planning (MVMAOT) [Ministerio de Vivienda, Medio Ambiente y Ordenamiento Territorial], and human health is the responsibility of the Ministry of Public Health (MSP) [Ministerio de Salud Pública].

In the veterinary field the regulatory framework established by Mercosur applies68, which was drawn up with participation by government officials and private entrepreneurs in the sector. The regulation was approved by Decree No. 160/97, with more requirements than those agreed upon in the Mercosur bloc. The authorizations of recombinant vaccines are considered on a case-by-case basis. To date, only one imported recombinant vaccine has been approved, for use in small animals.

The Ministry of Public Health (MSP) has the responsibility to formulate regulations regarding control of drugs, food and environmental health. The Department of Drug Control [Departamento de Registro, Uso y Control de Medicamentos], which belongs to the Quality Control Division [Division Control de Calidad] of the General Health Directorate [Dirección General de la Salud] of the Ministry of Public Health, authorizes and registers the drugs to be commercialized in the country. The Ministry is in the initial regulatory organization phase.

The National Directorate of Environment (DINAMA) [Dirección Nacional de Medio Ambiente] is responsible for formulating, executing, overseeing and assessing the National Environmental Protection Plans and as well as for proposing and implementing national policy on the matter. It is the enforcement authority of Law No. 16,466 which states that it is in the national public interest to protect the environment against any degradation, destruction or contamination, and to prevent any negative or harmful environmental impacts. The law considers harmful or negative environmental impacts to be any change to physical, chemical or biological properties which is caused by any form of matter or energy resulting from human activities which directly or indirectly affects the health, safety or quality of life, and the configuration, quality and diversity of natural resources. There are general regulations that do not specifically address the field of biotechnology.

Uruguay does not have a National System for Total Quality. This activity is performed by a National Quality Committee, which is a project of the Presidency of the Republic, whose purpose is to organize, direct and coordinate a National Quality Program. It was established by Decree No. 177 dated April 1, 1991. Its mission is to stimulate awareness of the transcendent importance of the quality level of the population’s well-being and to facilitate the implementation of modern quality management technologies in order to increase customer and user satisfaction and the survival, efficiency, growth and competitiveness of both public and private organizations.

The Technology Laboratory of Uruguay (LATU) [Laboratorio Tecnológico del Uruguay] provides a wide range of services to industry. Its main areas are: technology, analysis and testing, foreign trade and export promotion, and regulation and supervision of weights and measures. Its foreign trade area regulates the temporary admission system, which benefits industry in the development of production destined for export, exempting inputs from taxes or duties. This is a stimulus designed to increase local production, enabling it to compete with international markets on quality and price. LATU is considered key to the strategy for the development of the country in the field of biotechnology.

Biosafety and risk assessment of genetically modified plants

The assessment of genetically modified plants began in 1993 when experts from the Ministry of Livestock, Agriculture and Fisheries (MGAP) [Ministerio de Ganadería, Agricultura y Pesca] argued that the development of some technologies for transgenic plants would represent a reduction of deadlines for applications for introduction of such varieties in the country (PERALTA, 2000). From that time, when the first applications for the introduction of transgenic corn resistant to Lepidoptera appeared, until the present, cases were handled pertaining to various kinds of transformations including herbicide tolerance in crops of corn, soybeans, rice and eucalyptus, as well as low lignin content in the same genus.

As a result of those requirements, the Commission on Risk Analysis for the Introduction of Transgenic Plant Materials (CAAR) [Comisión Asesora de Análisis de Riesgo para la Introducción de Vegetales Genéticamente Modificados] was created, within the framework of the General Directorate of Agricultural Services (DGSA) [Dirección General de Servicios Agrícolas] of the Ministry of Livestock, Agriculture and Fisheries (MGAP) (PERALTA, 2000). DGSA is the area responsible for organizing and developing the protection of plant health and quality, and quality of plant foods and agricultural inputs, through the generation of regulatory and operational tools that allow economic agents to develop their activities in a transparent and equitable manner, improving productivity, quality and competitiveness of agricultural production and agribusiness. It also contributes to protect public health, the environment, the agro-system and consumer rights.

The Commission was composed of representatives of the National Institute of Agricultural Research (INIA) [Instituto Nacional de Investigación Agropecuaria], the National Seeds Institute (INASE) [Instituto Nacional de Semillas], the National Directorate of the Environment (DINAMA) [Dirección Nacional de Medio Ambiente] and the General Directorate of Agricultural Services (DGSA), from a wide variety of backgrounds, involving agronomists, experts in environmental assessment, chemists and molecular biologists, as well as lawyers. In 1998, the Commission requested the inclusion of a representative from the Ministry of Housing, Environment and Land Use Planning (MVMAOT), a request that was fulfilled in 1999.

The conceptual approach introduced by the Commission, in force to date, covers the study of the organism’s traits, its potential to induce genetic changes in populations, and monitoring and control of the accessible environment. To determine the level of environmental safety, risks to human health and natural ecosystems are considered, and the ability to manage its introduction and monitoring in a planned manner in order to ensure the trial’s safety. Predictions are also made regarding adverse environmental effects, potential for transformation of the organism and its environmental impacts and evaluation of the chances of its survival after the trial69.

The risk analysis considers each of the operations or applications performed with transgenic plants. It examines the organism and the molecular biology of the donor-recipient-vector system used for the production of the genetically modified plant, the location where they were all produced, the objectives of the introduction and, especially, a detailed description is made of the proposed biosafety methods and procedures. Where relevant, the following information is also required: the fate of harvested products, the parcels of land managed, its future uses and subsequent controls, as well as contingency plans if there is possibility of escape.

The stages of assessment and risk management have their own requirements. The information must be scientific, well-founded, published, and refereed. Experience or familiarity with the organism is important because it is quite likely that many organisms which are currently considered very hazardous, after some years will no longer pose the same hazard as they currently do, once a routine process of evaluating their use has been generated. Consideration should be given to the intended application for this particular organism, since different applications have varying levels of risk. Finally, there must be an effective surveillance program, monitoring process and adequate control of the location proposed for release.

Commission on Risk Assessment of Genetically Modified Plants (CERVGM)70

Introduction into the territory and use and handling of genetically modified plants and their parts should be implemented as soon as a risk assessment on scientific grounds has been performed, to consider their impact on the environment and biological diversity, taking into account the possible effects on human and animal health and plant safety. DGSA of MGAP, and INASE, have received advice from the Commission on Risk Analysis for the Introduction of Transgenic Plant Materials (CAAR) and processed applications for the introduction of genetically modified plant materials. The accumulated experience and nature of the risks involved have established the advisability of conducting risk assessments using a multi-disciplinary technical scope, with the participation of MSP and MVMAOT, for which for a national coordination body has been organized to advise the Executive branch on biosafety of genetically modified plant materials and parts.

As a result of the foregoing, the Commission on Risk Assessment of Genetically Modified Plants (CERVGM) [Comisión de Evaluación de Riesgo de Vegetales Genéticamente Modificados] has been established. The introduction, use and manipulation of genetically modified plant and their parts, in whatever the form or regime they are performed, can only be done with prior approval of the competent authorities. Authorizations will be considered for the following applications:

  1. Establishment of safe conditions for use under confinement.
  2. Conducting tests and trials in the field or under confinement within the specific biosafety conditions.
  3. National assessment of plant varieties.
  4. Seed multiplication.
  5. Production or import for the first time intended for direct consumption or for processing.

The competent authorities are: the Ministry of Livestock, Agriculture and Fisheries (MGAP) and the Ministry of Economy and Finance [Ministerio de Economía y Finanzas] for the approval of the application set forth in item (e) above and other applications not specifically provided for. These provisions shall not affect the powers of the Ministry of Public Health, as sanitary inspector for foods and medicines, nor those of the Ministry of Housing, Environment and Land Use Planning (MVMAOT)71.

The Commission on Risk Assessment of Genetically Modified Plants (CERVGM) is composed of one representative from each of the following entities:

  1. Ministry of Livestock, Agriculture and Fisheries (MGAP), who chairs the Commission.
  2. Ministry of Housing, Environment and Land Use Planning (MVMAOT), who serves as vice-chair.
  3. Ministry of Public Health (MSP).
  4. National Seeds Institute (INASE).
  5. National Institute of Agricultural Research (INIA) [Instituto Nacional de Investigación Agropecuaria].

The representatives and their subordinates, who should be technicians in risk analysis and biosafety, are designated by the above-mentioned entities. The Commission works under the General Directorate of Agricultural Services (DGSA) [Dirección General de Servicios Agrícolas] of the Ministry of Livestock, Agriculture and Fisheries (MGAP), which provides administrative support and the technical secretariat.

The Commission on Risk Assessment of Genetically Modified Plants (CERVGM) has the following duties:

  1. Developing guidelines for the implementation of risk assessments.
  2. Performing scientifically objective analysis on a case-by-case basis.
  3. Advising the competent authorities on the authorizations established.
  4. Advising the competent authorities on the handling, risk management and risk communication measures which should be taken in each case.
  5. Advising the Executive branch on biosafety of genetically modified plants and parts.

The Commission has the power to: (a) approve procedures for processing applications; (b) form working groups as it deems necessary; and (c) request advice of experts from universities and research centers, public or private, and independent experts recognized for their technical competence, acting in a personal capacity.

Before adopting a resolution, the corresponding competent authority makes available in its offices the authorization application, the results of risk assessment and other relevant documentation, so that anyone interested can access them and provide input in writing. In such a situation, it issues a notice to be published in the Official Gazette [Diario Oficial y del Registro Nacional de Leyes y Decretos] by the applicant and in two national newspapers, within a period of 20 days. In regards to authorization applications as set forth in item (e) or for applications not specifically provided for, the competent authority shall convene a public hearing for information and consultation, at a date later than the expiration of the period indicated on the manifest in the previous item (d).

In Uruguay, only transgenic soybean resistant to glyphosate is authorized for commercial production. Uruguay is cultivating 800 ha of transgenic soybean and unknown quantities of Bt corn. Being a relatively small country, Uruguay is influenced in contradictory ways by its two large neighbors, Argentina and Brazil, which are developing two distinct official strategies. Argentina is the second largest producer of genetically modified soybeans in the world, while in Brazil, only recently (since 2003) was commercial planting approved (Provisional Measure No. 113. of 2003).

Cartagena Protocol on Biosafety

In the process of negotiation of the Protocol on Biosafety, within the framework of the Convention on Biological Diversity, Uruguay is a member of the so-called Miami Group, composed by the United States, Canada, Argentina, Australia and Chile. Chile, which traditionally supports the importance of respecting the biosafety of the environment, opposes its use as a disguised barrier to international trade. Thus, these countries reject labelling and argue that the Protocol should not affect, in any case, the rights and obligations of the agreements of the World Trade Organization.

During discussions, the group rejected the introduction of the Protocol of processed food products, as well as products derived from genetically modified organisms, restricting the application of the treaty only to those GMOs exclusively meant for intentional release in the importing country. Uruguay signed the Cartagena Protocol on Biosafety on June 1, 2001, but has not ratified it.

Legislation promoting biotechnology development

Uruguay is a pioneer in establishing regulations promoting biotechnology development in the country. For this purpose, the National Committee for Biotechnology [Comité Nacional de Biotecnología] was created, under the Ministry of Education and Culture (MEC) [Ministerio de Educación y Cultura]72. The measure was a result of consideration of the importance and development of biotechnology and its processes in the following sectors: human health, pharmaceuticals, energy, and food, and in important aspects of animal health and cutting-edge technology in agriculture. In Uruguay, research is being developed on these technologies, in various public and private agencies, which requires coordination of development and better communication between institutes and companies performing biotechnology research and/or development work.

The National Biotechnology Committee is comprised of two delegates from Uruguay’s University of the Republic (UR), a delegate from the Clemente Estable Institute of Biological Research (IIBCE) [Instituto de Investigaciónes Biológicas Clemente Estable], two delegates from the Chamber of Industry and one delegate from each of the following agencies: the National Scientific and Technical Research Council (CONICYT) [Consejo Nacional de Investigaciones Científicas y Técnicas], the Ministry of Agriculture and Fisheries (MGAP), the Ministry of Industry and Energy (MIE) [Ministerio de Industria, Energía y Minería], the Ministry of Public Health (MSP), and the Ministry of Education and Culture (MEC). In 1987, the government issued Decree No. 626, on Biotechnology Research and Development, which promotes the tasks of research and development in companies, with emphasis on biotechnology.

These initiatives have expired and have not been replaced by new policies. In March 2001, significant steps were taken to develop a new policy phase for science, technology and innovation in biotechnology, through the Center for Prospective Technological Studies [Observatorio de Prospectiva Tecnológica], supported by the United Nations Industrial Development Organization (UNIDO), and reporting to the Presidency of the Republic, on the personal initiative of President of Uruguay, Jorge Batlle.