The U.S. Food and Drug Administration has announced the low-risk determination for the marketing of products derived from genome-edited beef cattle. The decision is the first low risk determination for marketing of products from an intentional genomic alteration (IGA) in an animal for food use.
IGA refers to changes introduced into the DNA of animals using biotechnological techniques, including genome editing. The IGA in the beef cattle led to a short-hair coat trait present in some conventionally bred cattle, known as a “slick” coat. After the FDA’s review of scientific data, the product was determined as low-risk and does not raise any safety concerns. Thus, FDA does not expect the developer to submit an application for approval before marketing the product.
“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, Director of the FDA’s Center for Veterinary Medicine.
“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,” he added.