Biden Administration reviewing USDA proposal to take over animal gene-editing regulation from FDA

A Department of Agriculture spokesman said in February that [the decision to shift regulatory authority of genetically modified livestock] is among many under review by the Biden administration. In March, USDA officials also provided notice they were seeking comments on the potential changes.

On Jan. 19, leaders in the USDA and Department of Health and Human Services signed an agreement that the USDA would take over portions of the Food and Drug Administration’s oversight of genetic modifications in agricultural animals and biotechnology for agricultural animals.

“Under this framework, USDA would safeguard animal and human health by providing end-to-end oversight from pre-market reviews through post-market food safety monitoring for certain farm animals modified or developed using genetic engineering that are intended for human food,” a USDA announcement states.

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The FDA would retain authority over genomic alterations for nonagricultural purposes and over dairy products, eggs, some meat products, and animal feed derived from modified animals, the announcement states. The memorandum also states that the FDA would implement a streamlined risk-based approach to oversight of intentional genomic alterations in animals.

Previously, the USDA had authority over genetic engineering of plants, while the FDA regulated all genetic engineering of animal species.

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