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

U.S. Department of Agriculture, Animal and Plant Health Inspection Service
WASHINGTON, September 01, 2022 – The U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) is making available two resources to answer stakeholder questions regarding the revised biotechnology regulations under 7 CFR part 340. The first new resource is Questions & Answers − Working with Microorganisms Developed Using Genetic Engineering Under 7 CFR part 340. This Q&A covers topics such as, what microorganisms are regulated, permit requirements, permit exemptions, and how to contact us and what information to provide if you are uncertain whether your microorganism is regulated.

The second resource is 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 CFR part 340, including information on how we treat off-target modifications when considering confirmation requests.

These resources, along with other information on the revised biotechnology regulations, can be found on the biotechquery. For questions regarding Confirmation Requests, contact us at BRS.ConfirmationRequest.