FDA has given the O.K. for genome-edited cattle to be used as meat after making a “low-risk determination” that the offspring of two genome-edited beef cattle may be used for food.
The cattle were bioengineered to have short hair, known as a “slick coat,” which helps the animals endure hot weather, and FDA determined that this intentional genomic alteration (IGA) did not raise any food safety concerns. This is FDA’s first-ever low-risk determination for enforcement discretion for an IGA in an animal for food use, which means that the agency has deemed that the product does not raise any safety concerns.
Steven M. Solomon, DVM, MPH, director of the FDA’s Center for Veterinary Medicine, notes that the decision demonstrates FDA’s commitment to using a risk and science-based, data-driven process that focuses on safety to the animals containing IGAs, as well as the safety to the consumers who eat the food produced by these animals. “It also demonstrates our ability to identify low-risk IGAs that don’t raise concerns about safety, when used for food production,” he said in a prepared statement. “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 IGA in these cattle, known as PRLR-SLICK cattle, was introduced using the genome-editing technique known as CRISPR. This IGA can be passed on to offspring so that the altered traits can occur through conventional breeding in subsequent generations.
In making its determination, FDA reviewed genomic data and other information submitted by the product developer and confirmed that the IGA in the PRLR-SLICK cattle is comparable 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 [seem] in cattle found in conventional agriculture,” Dr. Solomon said. “Further, the food from the [PRLR-SLICK] cattle is the same as food from conventionally bred cattle that have the same slick-hair trait.”
To date, only two other genetically modified animals have been approved for food use: AquAdvantage salmon, which have been genetically engineered with DNA from an ocean poutfish to grow more rapidly, in 2015, and GalSafe pork, which was approved in 2020 for human food consumption and for potential therapeutic uses. The IGA in GalSafe pigs is intended to eliminate alpha-gal sugar on the surface of the pigs’ cells; people with alpha-gal syndrome may have mild-to-severe allergic reactions to alpha-gal sugar found in red meat.
FDA has made low-risk determinations for enforcement discretion for other IGAs in animals for non-food uses, but has more recently approved applications for five IGAs in groups of goat, chicken, salmon, rabbit, and a line of pigs.
The developer of the PRLR-SLICK cattle plans to use the genetic products from these two animals with select customers in the global market soon and anticipates that meat products will be available for sale within the next two years.
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