USDA’s APHIS Announces New Microbes Q&A and Updated Confirmation Request Guidance

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.

These resources, along with other information on the revised biotechnology regulations, are available on the APHIS website. For additional questions regarding the regulation of modified microorganisms, contact APHIS at biotechquery@usda.gov. For questions regarding confirmation requests, contact APHIS at BRS.ConfirmationRequest@usda.gov.