Comment Period for Regulating Animal Biotech Reopened by USDA

The U.S. Department of Agriculture (USDA) has reopened the comment period for shifting regulatory authority pertaining to animal biotech. Initially, the comment period expired on February 26. USDA will now be accepting comments through the Federal Register until May 7. The proposal would put USDA in charge of regulating livestock and poultry created through genetic engineering. The U.S. Food and Drug Administration (FDA) has been the prevailing regulatory body for genetically altered animals.

“The FDA has been regulating this since 2009 and they regulate these as new animal drugs. That’s a very expensive and multigenerational process,” said Alison Van Eenennaam, Animal Genomics, and Biotechnology Specialist at UC Davis. “So, it’s definitely exciting that there’s a potential to have a more risk-proportionate and science-based regulatory approach for genetically engineered animals. I just hope that the community can get their voice heard.”

The Advanced Notice of Proposed Rulemaking to transition some regulatory oversight to USDA has received significant interest since it was published last December. The initial comment period garnered thousands of comments both for and against the proposal. There had also been disagreement on the proposal between previous Agriculture Sectary Sonny Perdue and then-FDA Commissioner Stephen Hahn.

The additional window for public comment will likely receive a similarly robust repose. FDA authority over genetic alternations in animals has long been scrutinized by the meat industry. New animal biotech innovations have been considered new animal drugs by FDA, triggering a rigorous regulatory process.

“It has been difficult for the animal biotech industry to get private funding and also even public funding to develop innovations because there has been no path to market,” Van Eenennaam explained. “If you have no path to market because the regulation is so expensive and unpredictable then you basically dry up investment in pursuing that approach to develop products.”