The proposal to move some regulatory authority for animal biotech to the U.S. Department of Agriculture (USDA) is receiving significant support. The Federal Drug Administration (FDA) has been the regulating body overseeing genetic engineering in animals, classifying them as animal drugs. FDA authority over the animal biotech industry has made research and development difficult due to regulatory constraints. Shifting regulatory oversight to USDA is being touted as a good start, however, there are still some concerns with the proposal.
“I think this is a step in the right direction, I don’t think that the approach of regulating them as animal drugs ever made a lot of scientific sense,” said Alison Van Eenennaam, Cooperative Extension Specialist in Animal Genomics and Biotechnology at UC Davis. “I’m supportive of USDA taking over the regulation of food animals that have been modified for agricultural purposes. What I don’t understand is why there’s a different approach for plants than for animals.”
USDA already regulates genetically engineered plants. Adding animal biotech to the department’s regulatory authority makes logical sense. However, Van Eenennaam questions some of the provisions within the proposal. There are certain regulatory exemptions for genetic changes in plants that could be achieved through conventional breeding. The same would not be true for animals under the proposed rulemaking. Genetic changes, no matter how small, or if they could be achieved through conventional breeding, will all fall under the same regulatory framework.
“If I do it using conventional breeding, I’m not covered [by regulation]. But if I do it using genome editing or one of these more molecular approaches then I have this really extensive regulatory pathway. That doesn’t make any sense to me why the difference between kingdoms,” said Van Eenennaam. “If you’re going to make it more difficult for animals to use this technology, there should be a scientific rationale for that.”
Overall, shifting oversight for animal biotech from FDA to USDA is a positive development according to many industry members. The process for making the change is still early on. The Advanced Notice of Proposed Rulemaking will allow for comments from stakeholders. Van Eenennaam encourages industry members to provide feedback to help guide the rulemaking process. The deadline to submit comments is Friday, February 26.
“This is our opportunity to comment, let’s not waste that opportunity,” Van Eenennaam noted. “I think science-based regulation is, to me, essential, and here’s our opportunity to ensure that these are based on science and that the regulations are proportional to product risk and not triggered by the use of a particular technology.”
Listen to the interview below.