Gene drives developed through gene editing are not banned, but it is unclear how they will be regulated. Genetically modified organisms (GMOs) are governed by the National Technical Commission for Biosafety (CTNBio) through Law No. 11,105 of March 24, 2005 which sets safety standards for GMOs. Although most gene drives being developed are GMOs, it is possible that gene drives will be developed using new breeding techniques (NBTs) that do not retain foreign genes and therefore do not meet the definition of a GMO. In 2018, CTNBio released a resolution that included gene drives as possible products developed using NBTs. The resolution clarified that new breeding techniques that do not introduce foreign genes would not be considered GMOs and did not ban gene drives from being developed. The resolution did not specify how gene drives developed using NBTs would be regulated.
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.
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.
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 would be prohibited.
In 2018, millions of people representing rural movements such as the National Coalition of Farmworkers and Rural, Water and Forest Peoples and the National Coordination of the Movement of Landless Rural Workers (MST) came together to protest the 2018 resolution allowing the release of gene drives into the environment. Counter NGO groups, including Target Malaria, Island Conservation and Genetic Biocontrol of Invasive Rodents Program, have adopted the opposite position, stating that “gene drive is vital to the future of restoration and critical in preventing extinctions”.
- 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