Biotechnology Law at Argentina
Argentina has a comprehensive and scientifically rigorous legal and regulatory framework for biotechnology, particularly concerning genetically modified organisms (GMOs). The country is a global leader in the cultivation of biotech crops, ranking third after the United States and Brazil. Argentina's approach to biotechnology regulation is characterized by a science-based, case-by-case assessment model, with a strong emphasis on environmental and food safety.
🇦🇷 Legal and Regulatory Framework
1. Key Legislation
Law on Seeds and Phytogenetic Creations (Ley de Semillas y Creaciones Fitogenéticas): This law provides a general legal framework for the commercialization of crops, including GMOs. It includes provisions for seed classification, registration requirements, and procedures for import and export.
Law on the Promotion of the Development and Production of Modern Biotechnology (Ley de Promoción del Desarrollo y Producción de la Biotecnología Moderna): This law aims to promote the development and production of modern biotechnology by granting tax incentives to qualifying research and production projects that meet safety and health standards.
2. Regulatory Authorities
National Advisory Commission on Agricultural Biotechnology (CONABIA): Established in 1991, CONABIA is the primary body responsible for assessing the environmental and food safety of GMOs. It operates under the Ministry of Agriculture, Livestock, Fisheries, and Food.
National Service for Agrifood Health and Quality (SENASA): SENASA evaluates the risks to human and animal health of food derived from GMOs.
Biotechnology Directorate: Part of the Ministry of Agriculture, this directorate coordinates seed registration and control and participates in international negotiations on biotechnology matters.
🧬 Regulatory Processes for GMOs
1. Prior Consultation Procedure
Argentina employs a "prior consultation procedure" for crops derived from new breeding techniques, such as genome editing. This process determines whether a product is considered a GMO under Argentine law. If the product contains a novel combination of genetic material, it is subject to regulation. The applicant must submit detailed information about the intended modifications, and CONABIA reviews the submission to decide on the regulatory status.
2. Environmental Risk Assessment (ERA)
The ERA process in Argentina has been updated to incorporate global scientific advances and the country's experience over the past 30 years. Key modifications include:
Assessing the interaction between traits in stacked GM crops
Strengthening the ERA by considering data transportability from confined field trials.
Adopting concepts like Familiarity and History of Safe Use (HOSU) in risk assessment.
Special considerations for unintended effects of insertional sites.
Reformulating the Insect Resistance Management Plan (IRMP) for post-commercial release.
3. Approval for Commercial Release
Before granting approval for the commercial release of a GMO, Argentina requires:
Environmental Risk Assessment: Conducted by CONABIA to evaluate potential impacts on the agricultural ecosystem.
Food and Feed Safety Assessment: Performed by SENASA to ensure the safety of GMOs for human and animal consumption.
Market Impact Assessment: Evaluated by the Directorate of Agricultural Markets to assess potential effects on international trade.
These assessments are based on scientific data and are conducted by expert commissions composed of representatives from both the public and private sectors.
🧪 Regulation of New Breeding Techniques (NBTs)
Argentina has established specific regulations for New Breeding Techniques (NBTs), such as genome editing. Resolution No. 173/2015 from the Ministry of Agriculture introduced a prior consultation procedure to determine whether products derived from NBTs are considered GMOs. If the product contains a novel combination of genetic material, it is subject to regulation. This approach has been adopted by several other South American countries.
⚠️ Biosafety and International Considerations
Argentina signed the Cartagena Protocol on Biosafety in 2000 but has not ratified it. The protocol regulates the transboundary movement of GMOs and adopts the "precautionary principle," allowing member parties to restrict or prohibit the import of GMOs if there is insufficient information about their safety. Argentina's decision not to ratify the protocol is primarily due to concerns that the restrictions it would impose on the free trade of GMOs could negatively impact the country's agricultural exports.
✅ Summary
Argentina's biotechnology regulatory framework is robust, science-based, and internationally recognized. The country has established clear procedures for the assessment and approval of GMOs and NBTs, with a strong emphasis on environmental and food safety. While Argentina has not ratified the Cartagena Protocol on Biosafety, it continues to play a significant role in global agricultural biotechnology.
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