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 most NBTs should not be regulated as transgenic GMOs because no genes are inserted 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 food or animal, whether new genetic material was introduced and whether the product has already been approved for commercialization in other countries.
- Hornless cows: In October 2018, the National Technical Biosafety Commission (CTNBio) determined that gene-edited hornless cows (edited using TALENS gene-editing tools) developed in cooperation with the US firm Recombinetics are conventional animals. As of 2019, this project is on hold as researchers develop a new line of hornless cows using CRISPR.
- Heat tolerant cows: Using TALENS, Minnesota Red Angus cows, whose meat is sold at a premium in Brazil, are being modified to handle the Brazilian heat more easily. Known as Genzel, the cloned cow awaits approval.
- Tender, marbled cow: Gene sequencing is being used to improve the tenderness and marbling in local Nelore cattle.
- High-yield tilapia: An application has been submitted to CTNBio for tilapia with higher fillet yield.
2018: The National Technical Biosafety Commission (CTNBio) released Normative Resolution No. 16, focusing on NBTs. It clarified that many products derived from genetic engineering do not meet the definition of a GMO as defined by the 2005 regulation and determined that NBTs should be regulated on a case-by-case basis.
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 derived from precision biotechnology and similar end products, obtained through other production methods.”
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 established the 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 foodstuffs. It provided for the punishment of administrative violations and criminal offenses. CTNBio has approved the commercial use of about fifty GMOs, 15 of which are animals.
2003: A decree was 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 passed Law No. 8.974, which established safety and inspection requirements for genetic engineering in agriculture and humans. The aim of the Act was to protect human, animal and plant health as well as the environment. It established which manipulation methods would be prohibited, including human genetic manipulation.
Local farmers and organizations have protested the 2018 CTNBio resolution deciding 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.
- Genetic Literacy Project’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