The path from the lab to the marketplace for genetically modified cows, pigs and chickens has been clearly spelled out for the first time.
On September 18, the U.S. Food and Drug Administration released a draft of regulations for approving engineered animals for commercial use. The draft is freely available and open for public comment until November 18.
The FDA’s announcement does not mark any major changes to its practices for approving genetically engineered animals for commercial use. But releasing the draft does signal that the FDA will continue to use the relatively stringent authority granted by the Federal Food, Drug, and Cosmetic Act instead of more lenient laws — a choice that some in the industry had begun to doubt.
“There’s nothing in this guidance that’s really new,” says FDA spokeswoman Siobhan DeLancey. “It’s how we’ve been regulating [genetically engineered] animals all along; we’re just making it official that this is how we intend to do it.”