Gene-Edited Beef Cattle Receive Low-Risk Determination from FDA

Two gene-edited beef cattle and their offspring have received a low-risk determination from the U.S. Food and Drug Administration (FDA). It marks the first time that an intentional genomic alteration (IGA) in an animal intended for human consumption has received such a determination. However, Animal Genomics, and Biotechnology Specialist at UC Davis, Alison Van Eenennaam explains that the determination is not an outright approval of gene-edited cattle.

“This particular decision is what’s called an ‘enforcement discretion,’” said Van Eenennaam. “It wasn’t an approval, but it wasn’t a ‘no’ either. So, it’s kind of turning a blind eye to some extent because they know this is a really low risk product and they’ve got better things to do with their time than enforce it.”

The company Recombinetics developed the cattle using CRISPR technology to give the animals the slick-hair trait found in other cattle. The trait is naturally occurring in other cattle, allowing the animals to be more heat tolerant. FDA reviewed all the data submitted by the company and found there to be no novel food safety hazard. Because of the enforcement discretion determination, the cattle will be allowed to enter commerce without going through the animal drug approval process which is typically how FDA regulates IGA in animals.

“If, however, you’re going for an approval, that becomes a much bigger ask. Not only do you have to provide data showing that you knocked out the gene but there’s also an ask about sequencing off-target effects. And then looking at the meat and milk composition of some sample animals to show that that didn’t alter from conventionally bred animals,” Van Eenennaam explained. “[FDA] also likes to see multigenerational studies. So, the offspring of the founder animals. It can get quite expensive.”

The regulatory structure for gene-edited beef and other genetically altered animals can be difficult to navigate. The process can be exceptionally arduous. Van Eenennaam highlighted genetically engineered AquAdvantage Salmon as taking more than 30 years to be approved as a new animal drug by FDA. In her blog, Van Eenennaam details the approval process for genomic editing in animals.