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Brazilian biosafety law and the new breeding technologies |
Alexandre Lima NEPOMUCENO1,9(), Renata FUGANTI-PAGLIARINI1, Maria Sueli Soares FELIPE2,9, Hugo Bruno Correa MOLINARI3,9, Edivaldo Domingues VELINI4,9, Eduardo Romano de Campos PINTO5,9, Maria Lucia Zaidan DAGLI6,9, Galdino ANDRADE FILHO7,9, Patrícia Machado Bueno FERNANDES8,9 |
1. Embrapa Soybean, Londrina 86001970, Brazil 2. Catholic University of Brasilia, Brasília 70790160, Brazil 3. Embrapa Agroenergy, Biological Station Park, Brasília 70770901, Brazil 4. Paulista State University Julio de Mesquita Filho, Botucatu Faculty of Agronomic Sciences, Botucatu 18610307, Brazil 5. Embrapa Biotechnology and Genetic Resources—Biological Station Park, Brasília 70770900, Brazil 6. São Paulo University, Veterinary Faculty, São Paulo 05508900, Brazil 7. Londrina State University, Microbiology Department, University Campus, Londrina 86051990, Brazil 8. Espírito Santo Federal University, Biotechnology Post Graduation, Vitória 29040090, Brazil 9. CTNBio (National Biosafety Technical Commission), Brasília 70610200, Brazil |
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Abstract: Globally, the area of land cultivated with genetically modified (GM) crops has increased a thousand-fold over the last two decades. Although this technology has become important for food production, the regulatory frameworks that underpin these outcomes are based on a list of requirements for a risk assessment that differ from country to country. In recent years, policymakers have had the opportunity to learn from the controversies over transgenics to create effective regulatory milestones for emerging technologies, allowing them to reach their potential for a more sustainable agriculture, ensuring food security. In Brazil, Law No. 11.105 of 24 March 2005 established a framework with four main organizations responsible for risk assessment and management. However, most of new breeding technologies did not exist at that time and were not considered in this law. In 2016, Normative Resolution No. 16 of the National Biosafety Technical Commission (CTNBio) was established to address this gap based on the evaluation of the products obtained through these techniques (termed Innovative Precision Improvement Techniques in the resolution), in a case-by-case consultation system. Briefly, if the product is designated to be a GM, the developer will have to go through the biosafety requirements and will be approved only after CTNBio risk assessment. If the product is designated not to be GM (for the purposes of the legislation), then it can be registered using the existing procedures. Currently, 152 GM products are commercially approved in Brazil. In 2018, CTNBio assessed the first consultation on commercial release of plants generated using the new breeding technologies and has subsequently approved six products. It is expected that many institutions would be able to participate in Brazilian and world markets, developing and introducing new biotechnological solutions and products through a more sustainable approach and without facing public disapproval, a common issue for GM crops. |
Keywords
Brazilian legislation
CTNBio
genetically modified crops
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发布日期: 2020-04-28
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Biotechnology Information Board, 2019(in Portuguese). Available at CIB website on October 8, 2019
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