USDA Proposes to Oversee Regulatory Jurisdiction of Some Genetically Engineered Animals

A USDA advanced notice of proposed rulemaking (ANPRM) is seeking public comment on amending and clarifying regulatory jurisdiction over genetically engineered agricultural animals. The proposal would see regulation of agricultural animals developed using genetic engineering transition from the FDA to USDA. Currently, the Food and Drug Administration oversees regulation of intentional genomic alterations in animals as animal drugs under the Federal Food, Drug, and Cosmetic Act. Comments will be received until February 26, 2021.


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