FDA Animal Biotechnology Webinar Case Study for a Low-Risk Intentional Genomic Alteration in Animals for Food Use

The U.S. Food and Drug Administration’s Center for Veterinary Medicine (CVM) is posting an informational, pre-recorded animal biotechnology case study webinar. This webinar is intended to provide an overview of FDA’s risk-based review process for intentional genomic alterations (IGAs) in animals that may pose low risk.

During this webinar, CVM will focus on 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.

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

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