At some point, the Food and Drug Administration might exempt gene-edited food animals from regulatory review, said Laura Epstein, a senior policy analyst at FDA’s Center for Veterinary Medicine, on Tuesday. “We’re not there yet, but we are open to getting there in the future,” said Epstein during a Farm Foundation panel discussion on the evolution of federal regulation of agricultural biotechnology.
Epstein responded to a question from University of California-Davis researcher Alison Van Eenennaam, who has used gene editing to prevent dairy cattle from growing horns. Like other proponents of gene editing, Van Eenennaam says the technique achieves the same results as traditional breeding but does it more rapidly. In a questions submitted electronically, she asked if FDA would exempt from regulation a gene-edited animal that presented a low risk of food or public health safety.
“It may be going forward,” said Epstein, that as the field of gene-edited animals becomes larger and FDA develops confidence in its ability to identify gene alterations that need attention that it would decide that some animals do not need regulatory scrutiny. “It’s early days.”
President Trump signed an executive order in June for a streamlining by USDA, FDA and EPA of their agricultural biotech regulations. Referring to gene-edited crops and animals, the executive order calls on the agencies to use their existing powers “to exempt low-risk products of agriculture biotechnology from undue regulation.” Epstein and officials from EPA and USDA said at the Farm Foundation Forum that they were working diligently to adopt new rules that reflect the executive order.
To listen to an audio recording of the panel discussion, click here.