Gene-edited crops and food are regulated as conventional plants unless they contain foreign DNA, after a dossier is submitted to determine if they are exempt. Changes introduced in January 2018 determined that NBTs should not be regulated as transgenic GMOs when no genes are retained from other (e.g. foreign) species. Each product is evaluated on a case-by-case-basis. Regulations focus on the characteristics of the final product, as does the US, rather than the process used to create the product, as is the case in the EU. The government assesses the risk level of each newly developed plant or food, whether new genetic material was introduced and whether the product has already been approved for commercialization in other countries, and responds to the applicant within 20-90 business days.
Genetically modified organisms (GMOs) are governed by the National Technical Commission for Biosafety (CTNBio), which sets safety standards for GMOs. In 2018, CTNBio declared that new breeding techniques that do not possess foreign genes would not be considered GMOs. The resolution establishes the requirements for whether a product can be exempt from the GMO regulatory framework.
Products/Research
- Spicy tomato: The Federal University of Viçosa developed a tomato with capsaicinoids, the compounds that give spicy peppers their heat.
- Nematode-resistant soybean: The Brazilian company Tropical Melhoramento & Genética and the Israeli company Evogene collaborated to develop a soybean resistant to a plant parasite that destroys crops and decreases crop yields.
- Yeast for biofuel production: An application was submitted to CTNBio for gene-edited yeast that can be used for ethanol and bioethanol production.
- “Waxy” maize: An application was submitted to CTNBio for gene-edited corn with extra starch.
- Antioxidant-rich tomato: The University of Viçosa, University of São Paulo and the University of Minnesota developed a tomato with high levels of lycopene, an important antioxidant. For research purposes only.
- Yeast for bioethanol: Four gene-edited varieties of yeast for production of bioethanol and other purposes were approved by CTNBio in 2018.
Regulatory Timeline
2018: Brazil and 12 other nations, including Argentina, Australia, Canada and the US, issue a joint statement supporting agricultural applications of precision biotechnology, stating that governments should “avoid arbitrary and unjustifiable distinctions between end products (crop traits) derived from precision biotechnology and similar end products, obtained through other production methods.”
2018: National Technical Biosafety Commission (CTNBio) releases Normative Resolution No. 16, focusing on NBTs. It clarifies that many products derived from genetic engineering do not meet the definition of a GMO as defined by the 2005 regulation and determines that NBTs should be regulated on a case-by-case basis.
2018: Ministries of Agriculture of the South Agricultural Council (Argentina, Brazil, Chile, Paraguay and Uruguay) publish declaration stating they would avoid arbitrary and unjustifiable distinctions between agricultural products obtained by gene editing and those obtained through other methods, share information about the development of products and regulatory frameworks, explore opportunities for regional and international harmonization, and work together including with other countries to avoid obstacles.
2005: Brazil establishes CTNBio under Law No. 11.105 to set rules for laboratories and establish authorization procedures for GMO research, the production and marketing of GMOs, restrictions on their release into the environment, regimes for their cultivation, requirements for reporting their release, inspections and monitoring of GMO research activities and their commercial release, implementing authorities and authorizing procedures for their release and restrictions on GMOs in foods. It provides for the punishment of administrative violations and criminal offenses. CTNBio has approved the commercial use of approximately fifty GMOs.
2003: Decree is issued to regulate the labelling of food and food ingredients intended for human consumption and animal feed when they contain or are produced from GMOs.
1995: Brazil passes Law No. 8.974, which establishes safety and inspection requirements for genetic engineering in agriculture and humans. The aim is to protect human, animal and plant health as well as the environment. It establishes which manipulation methods are prohibited.
NGO Reaction
Farmers and anti-biotechnology advocacy organizations protested the 2018 CTNBio resolution that determined that NBTs would not be regulated as GMOs. They published an open letter claiming that the resolution would only benefit large agricultural businesses and that it could lead to new transgenic organisms being released, even though it does not include transgenic organisms in the changes.
Additional Resources
- Genes and Science’s FAQ on gene editing
- Library of Congress summary of Brazilian gene regulations includes detailed analysis of the country’s evolving biosafety laws and liabilities
- USDA Biotechnology Annual 2019: Brazil
- The regulatory current status of plant breeding technologies in some Latin American and the Caribbean countries
