Worldwide, gene drive regulations are in flux. Gene drives are being developed using transgenic technology (GMOs) that contain foreign genes, as well as gene editing, including CRISPR (synthetic gene drives), which do not, complicating regulatory oversight as gene editing and GMOs are often regulated differently.
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. In 2018, CTNBio released a resolution that included gene drives as possible products developed using new breeding techniques (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.
Products/Research
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Regulatory Timeline
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.
2015: The British biotechnology firm Oxitec releases genetically modified mosquitoes that contain a gene that causes them to have nonviable offspring, to help reduce the spread of the Zika virus.
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.
NGO Reaction
Gene drives face fierce opposition from certain environmental advocacy groups, which claim that modified creatures might spread across borders and adversely impact the environment in unseen ways—claims most scientists say are overblown. The Canadian-based, international organization ETC Group and more than 200 global anti-GMO activists and NGOs published an open letter in 2016 opposing gene drives and called for a global moratorium. During the 2016 World Conservation Congress, a select group of NGOs, environmental activists and some scientists voted to adopt a moratorium on supporting research into gene drives. The moratorium call was rejected at the 2016 United Nations Convention on Biodiversity (CBD). In 2018, groups 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) protested 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”.
Additional Resources
- Genes and Science’s FAQ on gene editing
- Outreach Network for Gene Drive Research
- Gene drive research: Why it matters
