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This case study explores the use of low-risk intentional genomic alteration in animals for food use. It describes the benefits and risks of this technology, as well as the potential for its use in the future.

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

The U.S. Food and Drug Administration (FDA) is responsible for protecting the public health by ensuring the safety of our Nation’s food supply, including animal-derived food products. FDA also promotes the development and application of new technologies that can improve the safety and availability of our food supply, including animal-derived food products. One such technology is animal biotechnology, which can be used to intentionally alter an animal’s genome to improve its food-producing characteristics.

The FDA has prepared this case study to provide the public with information about the Agency’s regulatory oversight of low-risk, intentional genomic alterations in animals for food use. This case study describes the FDA’s approach to the regulation of such animals and discusses the Agency’s evaluation of a particular low-risk, intentional genomic alteration in Atlantic salmon.

The FDA is committed to ensuring that all animal-derived food products are safe and wholesome. The Agency will continue to evaluate new technologies, like animal biotechnology, that have the potential to improve the safety and availability of our food supply.

An informational, pre-recorded animal biotechnology case study webinar from the U.S. Food and Drug Administration’s Center for Veterinary Medicine (CVM). 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. The risk assessment summary described in the webinar is found here: fda.gov/media/155706/down…