Source: POLITICO'S MORNING AGRICULTURE, 10/31/18

The agency next year will roll out several guidance documents meant to provide "intensive assistance" for navigating its guidelines for biotech, including gene-editing in animals, as Helena Bottemiller Evich reported Tuesday. 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.

Even if just one small section of an animal's DNA is altered, Hanson said, scientists should be required to give the entire DNA sequence to regulators to ensure no mistakes were made that could pose a food-safety risk.

Too far? Some scientists say FDA's previously released guidelines go too far, and that the agency is attempting to regulate changes in animal genomes that could occur naturally.

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 — which is already FDA's approach to regulating GE plants.

The agency "makes an arbitrary distinction between an intentional edit [by humans] and an unintentional edit by nature," she told MA. "For some reason, human intention is considered a food risk, and I fundamentally reject that."

"My cows are not drugs," she added. "They're cows."