Gene editing provides a tool for scientists and farmers to grow more adaptable, healthier animals for meat production. However, the technology remains mysterious to many consumers, so proper monitoring has been a major sticking point for widescale adoption of animals with gene-edited abilities like shorter hair coats or greater feed efficiency.
Now, after years of back-and-forth between the Food and Drug Administration (FDA) and USDA about which group should regulate these animals and how, the FDA announced guidance that it will lead the charge and consult with USDA where necessary.
That’s in contrast to what USDA tried to do in 2020, when then-Secretary of Agriculture Sonny Perdue announced an attempt to transition the FDA’s existing oversight of animal biotechnology to his department. This was in response to an executive order calling upon federal agencies to reduce regulatory barriers that inhibit innovation in American agriculture.
In a memorandum of understanding (MOU) between the two departments released in April, it was stated that, “FDA regulates [intentional genomic alterations] in animals to ensure they are safe to the animal, safe to anyone that eats food derived from the animal, and that they are effective.” It was also noted that USDA’s Food Safety and Inspection Service is responsible for enforcing the Federal Meat Inspection Act, Poultry Products Inspection Act, and Egg Products Inspection Act.
FDA has already allowed gene-edited meat products including more feed efficient salmon, beef cattle with a shorter hair coat, and pigs with gene-edited traits intended to improve welfare into the market. FDA has more of a public health role than USDA, so some believe this alignment of roles makes the most sense.
The MOU also explained that records related to pending submissions of gene-edited products will be shared with USDA so they can evaluate certain scenarios for risks to disease transmission or animal health.
The SLICK gene mutation that results in a shorter hair coat is one genetic technology that has benefitted cattle producers dealing with heat stress. Found naturally in some populations of dairy animals, it has also been successful in being gene-edited into beef cattle with clustered regularly interspaced short palindromic repeats (CRISPR) technology. In 2022, FDA reviewed data from a group intending to market meat from these animals and determined that they posed low risk to public safety. These animals had the same genome as animals that naturally develop the mutation and produced food that was the same as food from conventionally-bred cattle, they said in that release.
