Proposal Would Transfer Regulation of Genetically Engineered Food Animals from FDA to USDA

According to a December 21 announcement, USDA is proposing that it regulate genetically engineered food animals, a responsibility currently held by FDA.

This initiative follows President Trump’s executive order on agricultural biotechnology that called upon federal agencies to make regulatory improvements to rectify some of the long-standing barriers to innovation for U.S. agriculture.

“Our livestock producers need all the tools in the toolbox to help protect against animal diseases and continue to meet the challenge of feeding everyone now and into the future. If we do not put these safe biotechnology advances to work here at home, our competitors in other nations will,” said U.S. Secretary of Agriculture Sonny Perdue. “Science-based advances in biotechnology have great promise to continue to enhance rural prosperity and improve the quality of life across America’s heartland and around the globe. With this effort, we are outlining a pragmatic, science-based, and risk-based approach that focuses on potential risk to animal and livestock health, the environment, and food safety in order to provide our farmers and ranchers the tools they need to continue to feed, clothe, and fuel the world.”

Under regulatory framework being contemplated, USDA would provide regulatory oversight from pre-market reviews through post-market food safety monitoring for certain farm animals developed using genetic engineering. USDA would promulgate regulations using the authorities granted to the department through the Animal Health Protection Act (AHPA), the Federal Meat Inspection Act (FMIA), and the Poultry Products Inspection Act (PPIA).

Pursuant to these authorities, the Animal and Plant Health Inspection Service (APHIS) would conduct a safety assessment of organisms developed using genetic engineering that may increase an animal’s susceptibility to pests or diseases of livestock, including zoonotic diseases, or ability to transmit the same. The Food Safety and Inspection Service (FSIS) would conduct a pre-slaughter food safety assessment to ensure that the slaughter and processing of animals developed using genetic engineering would not result in a product that is unsound, unhealthful, unwholesome, or otherwise unfit for human food.