March 30, 2022

FDA clears genome-edited beef cattle trait

FDA clears genome-edited beef cattle trait 

By: Sydney Sheffield

The United States Food and Drug Administration (FDA) announced it has made a low-risk determination for the marketing of products, including food, from two genome-edited beef cattle and their offspring after determining the intentional genomic alteration (IGA) does not raise any safety concerns (low-risk determination). This is the FDA’s first low-risk determination for enforcement discretion for an IGA in an animal for food use.

“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 M. Solomon, D.V.M., M.P.H., director of the FDA’s Center for Veterinary Medicine. “It also demonstrates our ability to identify low-risk IGAs that don’t raise concerns about safety, when used for food production. 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.”

The PRLR-SLICK cattle reviewed by the FDA had genes altered using CRISPR technology to have short, slick coats that let them more easily withstand hot weather. Cattle that aren’t stressed by heat might pack on weight more easily, making for more efficient meat production. The FDA predicts the beef could reach the market in about two years. 

This timeline prediction is not good news to everyone. Alison Van Eenennaam, an animal geneticist at the University of California, Davis who received the ASAS Rockefeller Prentice Award in Animal Breeding and Genetics in 2019, said requiring all companies to go through the lengthy approval process could end the possibility of commercializing gene-edited animals in the United States. Once the semen is used to create embryos, she said gestation would take about nine months and the resulting calves might be slaughtered after about 10 months. She noted the market isn’t limited to the United States, given the way cattle are bred.

The FDA reviewed genomic data and other information submitted by the product developer confirming that the IGA in genome-edited PRLR-SLICK cattle is equivalent to naturally occurring mutations that have arisen in several breeds of cattle as an adaptation to being raised in tropical or subtropical environments. The data also confirmed that the IGA results in the same slick-hair trait as in cattle found in conventional agriculture. Further, the food from the cattle is the same as food from conventionally bred cattle that have the same slick-hair trait.