On March 7, 2022, FDA announced that it had made a low-risk determination for two beef cattle (and their offspring) which contain an intentional genomic alteration (IGA) which results in short, slick-hair coating that is potentially able to withstand heat better. As a result, FDA will exercise it its enforcement discretion, and marketing of products from these cattle and their offspring, including for food uses, will not require pre-market approval.

Genetic alterations may be accomplished by incorporating spliced DNA sequences into animals through random integration events or, as is the case here, by using genome editing technologies (e.g., CRISPR) to introduce genetic alterations at specific sites. Both types of technologies result in IGAs which are regulated as animal drugs because the genomic alternation is intended to affect the structure and function of the body of the animal, and in some cases, is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in the animal. See 21 USC 321(g)(1) for the definition of “drug”. Thus, as a general matter, pre-market approval for each IGA is required.

However, as discussed in FDA’s Draft Guidance, FDA will exercise enforcement discretion where it determines such alterations present a low risk of harm. In this case, the IGA in the two beef cattle (called “PRLR-SLICK”) was found to be low risk because it is equivalent to naturally occurring mutations and results in the same short, slick hair trait found in conventionally raised cattle that have a history of safe use in agriculture and food production.

This is the first such determination that FDA has made for an animal intended for use in food. Thus, the FDA determination provides insight into how FDA determines that an IGA for animals for food use will be considered low-risk. A list of all IGA enforcement discretion determinations can be found here.