FDA Outlines Review Process for Genomic Alterations in Food Animals

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The U.S. Food and Drug Administration’s Center for Veterinary Medicine on Monday announced new resources for people interested in the development of intentional genomic alterations (IGAs) in animals.

These include a pre-recorded, on-demand webinar about the agency’s risk-based review process for IGAs in animals that may pose low risk, as well as revamped web resources for biotechnology products at CVM.

During the webinar, FDA presenters will provide an overview of the agency’s recent determination of low risk for the marketing of products, including food, from two genome-edited beef cattle and their offspring after determining that the IGA does not raise any safety concerns (low-risk determination). The IGA results in the equivalent genotype (genetic make-up) and short-hair coat trait seen in some conventionally bred cattle, known as a “slick” coat. During the webinar, the FDA will discuss risk questions the agency posed during its recent review of genome-edited beef cattle and will focus on its low-risk determination as a case study.

The FDA’s decision regarding the genome-edited cattle was the agency’s first low-risk determination and decision to exercise enforcement discretion for an IGA in an animal for food use. The FDA has previously made low-risk determinations and decisions to exercise enforcement discretion for many other IGAs in animals for non-food uses and also has approved applications for five IGAs: in groups of goatExternal Link DisclaimerchickenExternal Link DisclaimersalmonExternal Link Disclaimerrabbit and, most recently, in a line of pigs.

After viewing the webinar, stakeholders can provide feedback and any outstanding questions to FDA-CVM-Animal-Biotechnology-Feedback@fda.hhs.gov.

In addition to the webinar, you can find additional resources on the FDA’s recently updated website, “Biotechnology Products at CVM: Animals and Animal Food.” The website has been updated with new web resources, including additional sections and information on IGAs in animals, cell and tissue therapies for animals, the agency’s Veterinary Innovation Program, and a new section dedicated to CVM’s Animal Biotechnology Products Resource Center, which is designed to make it easier for stakeholders to find relevant information about these products and to answer questions about the FDA’s animal biotechnology review process.

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