Although genetically engineered crops are regulated by the USDA, which is liberalizing its oversight of gene editing, animal biotechnology is overseen by the Food and Drug Administration (FDA) based on an unusual reading of the federal 1938 Food, Drug and Cosmetic Act, and the FDA regulates gene editing very strictly. The FDA says that inserted DNA used to modify an animal is to be regulated as a “new animal drug” because the same gene inserted into two different animals of the same species creates two different entities to regulate, as DNA integrates itself into the genome at random.
Although the FDA has not officially announced how it will regulate gene edited animals, draft guidance from 2017 proposed gene editing in animals should also be regulated as a veterinary drug. This includes many of the same DNA insertions, substitutions, or deletions that could be obtained using conventional breeding. No longer is it the presence of a foreign gene that triggers mandatory premarket FDA regulatory oversight, but rather the presence of any “intentionally altered DNA” in an animal initiates regulation. No other country has taken this approach.
In 2018, the FDA announced a plan to clarify gene editing policies and create a clearer path to market for gene edited animals. The plan is expected to be risk-based, which means animals that are low risk would require minimal regulation. In 2019, the FDA started to identify animals with altered DNA that would be low-risk, and exempt from a safety review.
As a result of these uniquely strict regulations, no food from a genetically engineered animal has ever reached the US market. Many American scientists have relocated their gene editing research programs outside the country, particularly to Brazil. The National Pork Producers Council and other agricultural groups have petitioned the USDA to take over regulating gene edited animals because they regulate gene edited crops, but the FDA rejected this proposal.
- Cows that only have male calves: Developed by Recombinetics using CRISPR.
- Disease-resistant pigs: Genus, a UK biotechnology company, and researchers at the University of Missouri worked with the FDA to gain approval for pigs gene edited using CRISPR to be resistant to Porcine Reproductive and Respiratory Syndrome Virus (PRRS). Acceligen, a Recombinetics company, working on PRRS-resistant pigs using CRISPR.
- Disease-resistant cows: Researchers at Washington State University and Genus developed cows resistant to Bovine Respiratory Disease.
- Pigs resistant to the flu: Funded by the USDA, University of Maryland researchers developed pigs resistant to the flu virus using a gene editing technique called TALENs.
- Pigs that don’t need castration: Developed by the USDA’s Agricultural Research Service using TALENs.
- Hornless dairy cows: Developed by Recombinetics using TALENs.
- Heat-tolerant cows: Developed by researchers at the University of Florida to withstand hot, humid weather.
2019: Over 300 scientists sign a petition calling for the Harmonization of US gene-edited food regulations, asking that gene editing regulations for animals be the same as for crops and food.
2019: The National Pork Producers Council and other agricultural groups mount a campaign to transfer regulatory responsibilities to the USDA, which regulates gene edited crops, but the FDA rejected the proposal.
2019: An executive order is signed, known as Modernizing the Regulatory Framework for Agricultural Biotechnology Products, directing federal agencies (USDA, FDA and EPA) to exempt low-risk products from regulation and to create a unified platform that clearly outlines all regulatory requirements for approval of products developed with biotechnology.
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: GMO Labeling Act passed, which requires labeling of genetically engineered food products. It is not yet clear whether gene edited animals will require such a label.
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.
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.
1938: Food, Drug, and Cosmetic Act finalized, which defines a drug as anything “intended to affect the structure [or] function” of an animal.
The Center for Food Safety and other NGOs have said they will fight against weakening animal regulations if the FDA decides that any gene edited animals should not be strictly regulated as drugs.