On June 27, 2022, FDA’s Center for Veterinary Medicine (CVM) announced that it had published a pre-recorded animal biotechnology case study webinar. The webinar addresses the agency’s risk-based review process for intentional genomic alterations (IGAs) in animals that may pose a low risk.
As previously reported, on March 7, 2022, FDA announced its first low-risk determination for the marketing of products from genome-edited beef cattle and their offspring, following a safety review. CVM’s webinar uses this evaluation as a case study to provide insight into how the agency reached its determination that the IGA did not raise any safety concerns.
By way of background, IGAs in animals are changes to an animal’s genomic DNA that are produced using modern molecular technologies, such as random or targeted DNA sequence changes. The intended uses for IGAs in animals include applications in human health (e.g., reducing allergenicity), improved animal health (e.g., disease resistance), and enhanced production of food quality (e.g., feed efficiency). FDA’s draft guidance notes that FDA will exercise enforcement discretion where it determines that alterations present a low risk of harm.
© 2022 Keller and Heckman LLPNational Law Review, Volume XII, Number 182