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.
In a 2017 draft guidance, the FDA proposed that all intentional genome alterations in animals will be regulated as a veterinary drug.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 of genetically engineered animals, but rather the presence of any “intentionally altered DNA” in an animal’s genome that triggers 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. However, in 2020, the FDA released a statement using a new analysis of gene editing in cattle to defend its 2017 decision to require that every animal created by gene editing should be subject to mandatory premarket review and substantial safety testing. Scientists responded in an editorial, saying the agency’s position is at odds with the evidence, and that it appears designed to avoid legal battles with anti-GMO groups.
As a result of these uniquely strict regulations, no food from a genetically engineered animal has ever reached the US market. Some American scientists have relocated their gene editing research programs outside the country, particularly to Brazil, and others have formally written that the new animal drug regulatory approach is not “fit for purpose”. 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.
Products/Research
- Cows that only have male calves: Developed by University of California at Davis researchers using CRISPR.
- Disease-resistant pigs: Researchers at the University of Missouri used CRISPR to develop pigs to be resistant to Porcine Reproductive and Respiratory Syndrome Virus (PRRS). Genus, a UK biotechnology company is working with the FDA to gain approval. Acceligen, a Recombinetics company, working on PRRS-resistant pigs using CRISPR.
- Pigs that don’t need castration: Developed by Recombinetics using TALENs.
- Hornless dairy cows: Developed by Recombinetics using TALENs.
- Heat-tolerant cows: Developed by Acceligen to withstand hot, humid weather.
- Disease-resistant cows: Genus licensed a specific gene editing technology developed by researchers at Washington State University that could be used in the future to develop cows resistant to Bovine Respiratory Disease.
- Growth-enhanced catfish: Auburn University researchers used CRISPR to develop catfish with more muscle cells.
- Reptile research: University of Georgia researchers edited lizards using CRISPR, showing for the first time that the technique can be used on reptiles.
- Coral research: Stanford, the University of Texas, and the Australian Institute of Marine Science collaborated to study gene editing in coral with the goal of improving coral reef conservation efforts.
Regulatory Timeline
2020: FDA releases statement arguing that a new analysis indicates gene editing in cattle can have unintended consequences and supports the FDA decision to highly regulate to animal biotechnology. Scientists respond in an editorial claiming the agency’s position is at odds with the evidence, and that it appears designed to avoid legal battles with anti-GMO groups.
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.
2009: FDA’s Center for Veterinary Medicine (CVM) issues guidance document regulating DNA used to genetically engineer animals as a drug.
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.
NGO Reaction
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.
Additional Resources
- Genes and Science’s FAQ on gene editing
- US regulators grapple with oversight of New Breeding Techniques (NBTs) by Marc Brazeau
- What’s in the CRISPR drawer for farming and food? by Marc Brazeau
- Library of Congress summary of United States gene regulations includes detailed analysis of the country’s evolving biosafety laws and liabilities
