January 28, 2021

USDA Announces Oversight of GE Livestock

USDA Announces Oversight of GE Livestock 

The United States Department of Agriculture (USDA) has announced it will move forward with an Advance Notice of Proposed Rulemaking (ANPR) to seek public input and feedback on an anticipated regulatory framework that would update the nation’s system into a scientifically sound, risk-based, and predictable process that facilitates the development and use of these technologies for US farmers and ranchers under the USDA’s authorities. This announcement follows an executive order by President Donald Trump on agricultural biotechnology that called upon federal agencies to make regulatory improvements to rectify some of the long-standing barriers to innovation for US 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 USDA Secretary Perdue, in a press release. “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 the 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 the ANPR, 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). Following 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 as well.

This announcement means that portions of the Food and Drug Administration’s (FDA) pre-existing animal biotechnology regulatory oversight will be given to the USDA. USDA will consult with FDA to ensure its reviews benefit from FDA’s expertise while providing developers with a one-stop-shop for their products at USDA. USDA looks forward to FDA experts participating in the development of its review process. Through the ANPR, the USDA is proposing to establish a flexible, forward-looking, risk-proportionate and science-based regulatory framework that provides a predictable pathway to commercialization and keeps pace with advances in science and technology for certain farm animals developed using genetic engineering intended for agricultural purposes.

The announcement has generated praise among the livestock community. The National Pork Producers Council President Howard “AV” Roth, stated in a press release, “Today’s announcement is a big step forward for America’s farmers, who have weathered significant challenges over the past few years. FDA regulation of gene editing will result in an impractical, lengthy, and expensive approval process. Thankfully, that is not the administration’s intended plan. This announcement represents a critical milestone to ensuring American agriculture maintains its global competitive edge.”