USDA Announces Proposal to Regulate Agricultural Animal Biotechnology

On December 21, 2020, the United States Department of Agriculture (USDA) released an Advanced Notice of Proposed Rulemaking (ANPR) to seek comment on a contemplated regulatory framework that, if finalized, would transition to USDA portions of the Food and Drug Administration’s (FDA’s) pre-existing animal biotechnology regulatory oversight.

In particular, USDA proposes to use its existing authorities under the Animal Health Protection Act (AHPA), the Federal Meat Inspection Act (FMIA), and the Poultry Products Inspection Act (PPIA) to provide end-to-end regulatory oversight from pre-market reviews through post-market food safety monitoring for livestock, horses, Siluriformes (including catfish) and poultry that are intended for agricultural purposes and that are modified or developed using genetic engineering. Under this framework, USDA’s Animal and Plant Health Inspection Service (APHIS) would conduct a safety assessment to ensure that the covered animals are not more susceptible to or more likely to transmit pests or diseases. The USDA’s Food Safety and Inspection Service (FSIS) would conduct a pre-slaughter food safety assessment to ensure that the slaughter and processing of these animals would not result in adulterated products.

This ANPR was developed in response to a June 2019 Executive Order on agricultural biotechnology, which directed federal agencies to modernize the regulatory framework for agricultural biotechnology products.