There is no clear gene drive regulation in the United States. A guidance issued by the Food and Drug Administration (FDA) in 2009 stated that genetically engineered DNA constructs intended to affect the structure and function of an animal, regardless of their use, meet the criteria for veterinary drugs and are regulated as such. Therefore, gene drives would presumably be regulated by this guidance. However, it is unclear exactly how this guidance would apply to gene drives meant to control invasive species and gene drives in insects.
A report completed by the National Academy of Sciences concluded that three agencies will most likely be involved in regulating gene drives: the FDA, the Department of Agriculture (USDA), and the Environmental Protection Agency EPA. However, there are many regulatory overlaps and gaps. For example, gene drives could be regulated by the Federal Insecticide, Fungicide, and Rodenticide Act (enforced by the EPA) because an insect gene drive could function as an insecticide, the Toxic Substances Control Act (enforced by the EPA), and the USDA Animal and Plant Health Inspection Service (APHIS) which protects US agriculture and natural resources. It is unclear which agency or act will take the lead in regulating gene drives. In response to these regulatory gaps, the FDA and USDA both announced plans to update their gene editing regulations.
There are many gene drive research programs underway in the US, but no gene drives have been tested or released outside the lab. Researchers are investigating ways to build-in controls and external overrides into gene drives, so that they can be extinguished if necessary after they have been released. The Defense Advanced Research Projects Agency (the research arm of the Department of Defense; DARPA) is funding most of the research on gene drive safety and control. DARPA published a Safe Genes contract that forbids field testing until more research is completed. A company called Oxitec, which has field tested genetically engineered mosquitoes in Brazil, Panama and the Cayman Islands, was approved by the Florida Keys Mosquito Control District to conduct a field test, but the proposal was rejected by voters. Oxitec is now trying to get approval for a different Florida test site.
- Mice with white coats: Developed by researchers at the University of California, San Diego (UCSD) using CRISPR. This was the first gene drive test in mammals and was for research purposes only.
- Sterile flies: Developed by researchers at UCSD and University of California, Berkeley using CRISPR as a possible way to control disease-carrying or crop-destroying insects.
- Dengue-resistant mosquitoes: Developed by researchers at UCSD using CRISPR.
- Mosquitoes die when infected by any virus: Developed by researchers at USCD using CRISPR.
- Malaria-resistant mosquitoes: Developed by researchers at UCSD using CRISPR.
- Flightless mosquitoes: Developed by researchers at the University of California, Irvine using CRISPR to help curb the spread of Dengue fever.
2019: The USDA-APHIS proposes a new biotechnology regulation, Movement of Certain Genetically Engineered Organisms (also called the SECURE Biotechnology Regulations), which reduces the regulatory requirements for organisms that are unlikely to pose risks to other plants.
2018: The FDA announces its Plant and Animal Biotechnology Innovation Action Plan, pledging to clarify policies on gene editing and ensure developers have a clear path to efficiently bring a product to market.
2017: FDA releases draft guidance suggesting it will regulate gene edited animals as drugs, which involves extensive safety assessments.
2017: OSTP issues an Update to the Coordinated Framework (CF) for the Regulation of Biotechnology, which clarifies the current roles and responsibilities of, and coordination among, FDA, EPA, and the USDA-APHIS.
2016: OSTP issues a National Strategy for Modernizing the Regulatory System for Biotechnology Products, which presents a vision for ensuring that the federal regulatory system is prepared to assess future products of biotechnology.
2015: The Executive Office of the President (EOP) issues a memorandum directing the EPA, FDA and USDA to update the Coordinated Framework for the Regulation of Biotechnology, develop a long-term strategy and commission an expert analysis of the future landscape of biotechnology.
2009: FDA’s Center for Veterinary Medicine (CVM) issues guidance document stating genetically engineered DNA constructs intended to affect the structure and function of an animal, regardless of their use, meet the criteria for veterinary drugs and are regulated as such.
1996: Federal Insecticide, Fungicide, and Rodenticide Act finalized, which is enforced by the EPA. This act would most likely apply to any gene drives that are meant to control insect or rodent populations.
1987: Coordinated Framework for the Regulation of Biotechnology established, outlining the basic federal policy of the agencies (USDA, FDA and EPA) involved with reviewing biotechnology research and products.
1976: Toxic Substances Control Act finalized, which is enforced by the EPA. This act may apply to gene drives that may pose a health risk to humans.
1938: Food, Drug, and Cosmetic Act finalized, which defines a drug as anything “intended to affect the structure [or] function” of an animal.
Gene drives face intense opposition because of their ability to spread across borders and the possibility of unforeseen consequences to the environment. During the 2016 World Conservation Congress, NGOs, government representatives and scientific and academic institutions voted to adopt a moratorium on supporting or endorsing research into gene drives. In addition, a group of conservationists, including Dr. Jane Goodall, signed an open letter calling for a halt to gene drive proposals. 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”.