March 29, 2021

Comment period on animal biotechnology reopened

Comment period on animal biotechnology reopened

The United States Department of Agriculture (USDA) is reopening the public comment period for an Advance Notice of Proposed Rulemaking (ANPR) regarding whether to establish regulations for the movement of certain animals modified or developed using genetic engineering. Under the contemplated regulatory framework, USDA would use 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) to evaluate organisms developed using genetic engineering. 

On December 28, 2020, the Animal and Plant Health Inspection Service (APHIS) and the Food Safety and Inspection Service (FSIS) announced the availability of the ANPR for a 60-day public review and comment period, which closed on February 26, 2021. APHIS and FSIS are reopening the comment period for 60 days to allow interested persons more time to prepare and submit comments. Comments will now be accepted through May 7, 2021.

In the final days of the Trump administration, the USDA and Health and Human Services (HHS) announced a memorandum of understanding to allow for the USDA to have jurisdiction over the regulation of these animals. However, the FDA continued to oppose transferring oversight. The USDA is considering regulations that would establish a flexible, risk- and science-based regulatory framework for the regulation of certain animals modified or developed using genetic engineering that are intended for agricultural purposes.

The comment period is now open. To submit a comment for consideration, please go to this website.