FDA Makes Low-Risk Determination for Marketing of Products from Genome-Edited Beef Cattle After Safety Review

SILVER SPRING, Md., March 7, 2022 /PRNewswire/ -- Today, the U.S. Food and Drug Administration announced it 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. This is the 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."

Based on the agency's review of scientific data, the FDA has determined that the product is low-risk and does not raise any safety concerns, and the FDA does not expect the product developer of the IGA to pursue the FDA's approval prior to marketing (enforcement discretion). To date, the FDA has made low-risk determinations for enforcement discretion for many other IGAs in animals for non-food uses and also has approved applications for five IGAs: in groups of goat, chicken, salmon, rabbit and, most recently, in a line of pigs.

IGAs are alterations made using molecular technologies that introduce changes to the genome of an animal. The IGA in these cattle, known as PRLR-SLICK 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. There are conventionally bred cattle with naturally-occurring mutations that result in the same extremely short, slick-hair coat. Reports in scientific literature indicate that cattle with this extremely short, slick-hair coat are potentially able to better withstand hot weather. Cattle that are comfortable in their environment are less likely to experience temperature-related stress and may result in improved food production. Although PRLR-SLICK cattle have an equivalent trait to those cattle with a naturally-occurring short hair coat, they are not currently in commerce. 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.

The FDA reviewed genomic data and other information submitted by the product developer confirming that the IGA in genome-edited PRLR-SLICK cattle is equivalent to naturally occurring mutations that have arisen in several breeds of cattle as an adaptation to being raised in tropical or subtropical environments. The data also confirmed that the IGA results in the same slick-hair trait as in cattle found in conventional agriculture. Further, the food from the cattle is the same as food from conventionally bred cattle that have the same slick-hair trait.

The FDA does not expect farms or facilities not owned or operated by the developer that are producing and breeding these low-risk PRLR-SLICK cattle using conventional breeding techniques to register with the agency. The low-risk determination was provided to Acceligen.

Additional Resources:

• Animals with Intentional Genomic Alterations
• Intentional Genomic Alterations in Animals: Enforcement Discretion
• Draft Guidance for Industry: Regulation of Intentionally Altered Genomic DNA in Animals
• Risk Assessment Summary: PRLR-SLICK Cattle

Media Contact: Kim DiFonzo, 240-651-4191
Consumer Inquiries: 888-INFO-FDA

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

SOURCE U.S. Food and Drug Administration