FDA 'Approves' First Gene-Altered Animal for Food Use

March 7, 2022
Agency's first 'low-risk determination' paves way for Acceligen's slick-haired cattle for food use.

The FDA today (March 7) essentially approved the first gene-altered animal for food use. The animal group, called PRLR-SLICK cattle, will have an extremely short, slick-hair coat that should enable them to better withstand hot weather. Experiencing less temperature-related stress should result in improved food production.

Technically, the agency 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. The IGA results in the same short-hair coat trait seen in some conventionally bred cattle.

This is the FDA’s first low-risk determination for enforcement discretion for an IGA in an animal for food use, the agency wrote in a news release.

“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 Solomon, D.V.M., M.P.H., and 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.”

The FDA has made low-risk determinations for several other IGAs in animals for non-food uses and also has approved applications for five IGAs: in groups of goatExternal Link Disclaimer, chickenExternal Link Disclaimer, salmonExternal Link Disclaimer, rabbit and, most recently, in a line of pigs.

The IGA in these cattle was introduced using a genome-editing technique known as CRISPR. The IGA can be passed on to offspring, allowing the trait to be shared through conventional breeding.

Although it's a little vague in the FDA announcement, the applicant appears to be Acceligen, an animal "precision breeding" company. According to FDA, "The product developer plans to use the genetic products from these two animals with select customers in the global market soon and anticipates meat products will be available for purchase by general consumers as early as two years."

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