While 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). In contrast to the oversight of genetically engineered crops, GE animals, both transgenic and gene edited, are regulated based on the process of alterations rather than on the product. Animal biotechnology scientists and companies poised to develop new products claim the current regulatory structure is cumbersome and outdated, and that it effectively blocks most approvals.
Current regulations in the US are based on an unusual reading of the federal 1938 Food, Drug and Cosmetic Act, which has been extended to regulate animal gene editing as well as transgenics. Investigational research animals that have been genetically altered cannot enter the food supply in the US irrespective of the edits they carry unless the researcher that has produced that animal has submitted an FDA Investigational New Animal Drug (INAD), and additionally has obtained a food use authorization which is almost never issued.
Under the current regulatory approach globally to food animal breeding, if genomic selection is used to identify animals with genomes that promote heat tolerance or disease resistance, these animals face no additional regulatory burden. But in the US, and only in the US, if an alteration is intentionally and precisely introduced into the genome using modern biotechnologies to achieve these same traits, the alteration must be approved as a new animal drug for the animals before a product is legally allowed to enter commerce.
The FDA has consistently blocked entreaties to revise its regulatory structure for genetically engineered animals and/or pass oversight to the FDA. In 2017, FDA issued a Draft Guidance that reaffirmed that the presence of any “intentionally altered DNA” in an animal’s genome triggers the 1938 regulation.
In 2018, the FDA rebuffed recommendations by legislators and many animal agricultural biotechnologists to transfer oversight to the USDA.
In 2019, FDA proposed a risk-based regulatory structure to replace the current process-based system, but rebuffed recommendations to drop reliance on the 1938 regulation or to shift oversight to the USDA and specifically rejected transferring authority to the USDA.
In 2020, 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 under the 1938 statute. Many 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.
In an attempt to reform the current system, in January 2021, outgoing Secretary of Agriculture Sonny Perdue proposed a new regulatory framework in a Memorandum of Understanding issued jointly with the FDA that would have transitioned portions of FDA’s pre-existing animal biotechnology regulatory oversight to USDA. The incoming administration did not follow through with this recommendation.
To date, three genetically-engineered food animal products are commercially available in the United States. In 2015, The FDA granted its first approval for a genetically engineered (GMO) food animal, a line of Atlantic salmon modified by AquAdvantage to grow to market size in half the time of conventional salmon. In 2020, the agency approved a genetic alteration in pigs that eliminates a sugar molecule known to trigger a rare allergy in humans, and those GalSafe Pigs are sold for medical uses and as meat. In 2022, the FDA approved a gene-edited short-haired, heat-tolerant beef cattle for human consumption.
In response to the effective block on animal biotechnology in the US, some American scientists have relocated their gene editing research programs outside the country, particularly to Brazil and Argentina.
Products/Research (partial list as many products are in development)
- Approved Heat resistant beef cattle: Developed by Acceligen (a Recombinetics company) and approved in 2022, the cattle’s DNA has been altered to grow slicker and shorter coats allowing for improved heat regulation which in turn allows them to gain weight easily.
- Cows that deliver only 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), developed by Genus, a UK biotechnology company.
- Acceligen is working on PRRS-resistant pigs using CRISPR.
- Pigs that don’t need castration: Developed by Recombinetics using TALENs.
- Hornless dairy cows: Developed by Recombinetics in 2020 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
2021: Outgoing US Secretary of Agriculture issues a Memorandum of Understanding with the FDA recommending transitioning portions of FDA’s regulatory oversight to USDA, but the incoming administration does not follow through with this recommendation.
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 animal biotechnology.
2020: 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: More than 300 scientists petition the USDA, calling for the Harmonization of US gene-edited food regulations and challenging the regulation of animal biotechnology as drugs.
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
- FDA Regulation of Plant and Animal Biotechnology Products
- 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
- Q&A on FDA Regulation of Intentional Genomic Alterations in Animals
- GMO Crops and Food for Animals
- Food and Agriculture organization of the United Nations: Gene editing and food safety
