Regulated on a case-by-case basis based on the product produced, not the process used.
Brazil has among the most flexible regulations on gene editing and other new breeding techniques (NBTs) of crops and animals. Sweeping changes introduced in January 2018 determined that 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 developed in cooperation with the US firm Recombinetics are conventional animals and allowed these cows and their products to enter the market.
- Heat tolerant cows: Using TALENS gene-editing tools, 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.
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.
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