The FDA announced in May 2024 that the agency will lead the charge on regulation of animals with intentional genomic alterations (IGAs). In its guidance, the FDA stated that the agency will consult with the USDA, but that the FDA will primarily be in charge of regulating these animals. Newly developed gene-edited animals will need to go through an oversight process, in which the agency will assess potential risks, before they can enter the market. Products that represent limited risk will receive proportionately less oversight.

For the past several years, it was unclear which agency, the FDA or the USDA, would regulate genetically engineered animals. [Center for Science in the Public Interest, or] CSPI argued in two op-eds, appearing in The Hill and STAT, that the FDA should be the agency to regulate these animals. For one, the FDA’s mandate includes public health and animal health, while the USDA’s mandate includes promoting the US agricultural industry and does not center human health. Additionally, while the USDA has oversight over some agricultural animals—poultry, cattle, horses, swine, and goats—the FDA has authority over all others, so a system not centered on the FDA would be inefficient. Finally, the FDA has pre-existing experience in regulating genetically engineered animals, as well as the scientific resources and regulatory framework needed to effectively tackle regulation of these animals.

As CSPI President Dr. Peter G. Lurie stated, “The FDA’s scientific expertise and human and animal health mandates make it the appropriate agency to maximize the benefits and minimize the risks of the next generation of genetically altered animals.”

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