The [FDA in 2019] will roll out several guidance documents meant to provide “intensive assistance” for navigating its guidelines for biotech, including gene-editing in animals…. The plan is to create “an efficient, science-based pathway to market for safe animal biotechnology-derived products.”
Industry insiders on both sides of the issue question whether FDA has the authority to regulate gene-edited animals. Jaydee Hanson, senior policy analyst for the Center for Food Safety, has been pushing FDA to develop regulations for decades. He said the agency is in a unique position to institute these regulations, given its previous experience overseeing genetically modified animals used in drug testing.
Alison Van Eenennaam, an animal biotechnology expert at the University of California, Davis, has been working to remove the part of DNA responsible for giving cows horns. Dairy producers typically prefer hornless animals as a matter of animal safety.
Under FDA’s approach, Eenennaam said, her hornless cows are considered “drugs” that need to undergo regulatory review. While she agrees that some genetically modified animals should be regulated, she argues the agency shouldn’t regulate changes to an animal’s DNA that already occur in nature ….
The agency “makes an arbitrary distinction between an intentional edit [by humans] and an unintentional edit by nature …. My cows are not drugs,” she added. “They’re cows.”
Read full, original article: FDA FORGING AHEAD ON ANIMAL BIOTECH