By Lynn L. Bergeson and Carla N. Hutton
On September 1, 2022, the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) announced the availability of two new resources to answer stakeholder questions regarding the revised biotechnology regulations under 7 C.F.R. Part 340:
- “Questions & Answers -- Working with Microorganisms Developed Using Genetic Engineering Under 7 CFR part 340”: The questions and answers (Q&A) cover topics such as what microorganisms are regulated, permit requirements, permit exemptions, and how to contact APHIS and what information to provide; and
- Updated Confirmation Request Guidance: The updated guidance provides clarification on preparing and submitting requests to APHIS to confirm a modified plant qualifies for an exemption and is not subject to the regulations in 7 C.F.R. Part 340, including information on how APHIS treats off-target modifications when considering confirmation requests.