FDA Makes Low-Risk Determination for Marketing of Genome-Edited Beef Cattle Products
The U.S. Food and Drug Administration (FDA) has made a low-risk determination for the marketing of products, including food, from two genome-edited beef cattle and their offspring, after determining that the intentional genomic alteration (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. The decision is FDA’s first low-risk determination for enforcement discretion for an IGA in an animal for food use.
“Today’s decision underscores our commitment to using a risk and science-based, data-driven process that focuses on safety to the animals containing intentional genomic alterations and safety to the people who eat the food produced by these animals,” said Steven M. Solomon, D.V.M., M.P.H., Director of the FDA’s Center for Veterinary Medicine. “It also demonstrates our ability to identify low-risk IGAs that don’t raise concerns about safety, when used for food production. We expect that our decision will encourage other developers to bring animal biotechnology products forward for the FDA’s risk determination in this rapidly developing field, paving the way for animals containing low-risk IGAs to more efficiently reach the marketplace.”