Loosest gene drive regulations in the world.
Brazil is the first country in the world to establish a regulatory path for gene drives to be released into the environment. 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. However, in 2018, CTNBio released a resolution that eased restrictions on gene drives by allowing them to skip many of the regulatory hurdles normal GMO products must pass through. The resolution also declared that new breeding techniques that do not introduce foreign genes would not be considered GMOs.
Scientists and farmers are worried that the loose gene drive regulations do not take into account the possible risks associated with gene drives. The resolution could potentially make it easier to release a gene drive than a GMO seed.
- Mosquito trials: The UK firm Oxitec has been conducting field trials by releasing their strain of mosquitoes into various Brazilian neighborhoods since 2011 to address the spread of diseases from mosquitoes. However, these have only been research tests, as the mosquitos have yet to be approved for commercial release.
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