FDA Makes Breakthrough Decision on Genome Edited Livestock

The U.S. Food and Drug Administration (FDA) issued a landmark opinion on gene editing in livestock on March 7, 2022.

FDA officially issued a “low-risk determination” for the marketing of products, including food, from two genome-edited beef cattle and their offspring. The agency determined that the intentional genetic alteration (IGA) does not raise any safety concerns.

The animals under consideration have a short-haired or “slick” hair coat, a trait they received as the result of a genome-editing technique known as CRISPR. The slick hair coat is a relatively rare, but naturally occurring, trait that improves heat tolerance.

Unlike genetically modified organisms (GMOs), genome editing simply knocks out a genetic trait and replaces it with a more desirable one.  Once the intentional genome alteration (IGA) is in place, it is passed on naturally to offspring, allowing the trait to be shared through conventional breeding.

The result is accelerated transmission of a trait that already was occurring naturally, albeit at a slower rate.

This first-of-its-kind decision by FDA opens the door for progress on other genome editing efforts, including the swapping of the polled gene into conventionally horned cattle bloodlines.

“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,” said Steven Solomon, director of the FDA’s Center for Veterinary Medicine. He predicted the move would pave the way for animals containing low-risk IGAs to reach the marketplace more efficiently.

But University of California-Davis researcher Alison Van Eenennaam, who has pioneered research on genome editing with the polled trait, is not as optimistic. She said requiring research companies to go through the lengthy FDA approval process for each individual trait could end the possibility of commercializing gene-editing animals in the U.S.

Meanwhile, research on genome editing in animals is moving to markets outside the U.S. – including Brazil, China, Argentina, Australia, and Canada – where regulatory paths are not as confining.