USA, Silver Spring. The FDA announced its first low-risk determination for an intentional genomic alteration in an animal for food use.
On Monday, the US Food and Drug Administration (FDA) announced its low-risk assessment for the marketing of products, including food, from two genome-edited beef cattle and their offspring. According to the FDA, the intentional genomic alteration (IGA) does not raise any safety concerns.
The IGA results in the equivalent genotype and short-hair coat trait seen in some conventionally bred cattle, known as a "slick" coat (SLICK). Several studies have linked the SLICK locus to improved thermo-tolerance with tropically adapted cattle. Cattle with an increased heat tolerance while maintaining standards of milk yield, reproduction and disease resistance gain further importance due to the effects of climate change.
"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, DVM, 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. It has also approved applications for five IGAs in goat, chicken, salmon, rabbit and a line of pigs.
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.