The Food and Drug Administration has paved the way for gene-edited beef to hit the US market. The agency declared March 7 that two gene-edited beef cattle produced by Acceligen do not raise any safety concerns.
The FDA determined that the two cows, which have a genetic trait that gives them a short, slick coat, are low-risk. That determination means the agency does not expect Acceligen to seek regulatory approval before marketing products, including food, made from the cattle. This is the first time the FDA has made a low-risk determination and used its discretion not to enforce premarket approval of a gene-edited animal for food use.
The decision shows the FDA’s “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,” Steven Solomon, director of the FDA’s Center for Veterinary Medicine, says in a statement. The agency expects the decision to encourage other developers to use the risk-determination pathway to bring animal biotechnology products to market more efficiently, Solomon says.
The slick-coat trait in the gene-edited cows is identical to naturally occurring genetic mutations found in some cattle raised for food in tropical or subtropical climates. The trait allows cattle to better tolerate hot weather.
Acceligen introduced the slick trait into the cows using the gene-editing technology CRISPR-Cas9. The company altered the prolactin receptor gene to shorten the prolactin receptor protein. The genomic alteration is heritable, so it can be passed down to offspring.
“The SLICK trait, which occurs naturally in certain cattle, will be used to transform beef production to be more sustainable and improve animal welfare in warmer climates,” the company says in an emailed statement.
Acceligen would not say when consumers might see beef from CRISPR cows in US grocery stores. It is also unclear whether meat from the gene-edited cows will be labeled any differently than conventional meat.