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

On September 1, USDA Animal and Plant Health Inspection Service (APHIS) released two resources to answer stakeholder questions regarding its revised biotechnology regulations under 7 CFR part 340.

The first resource is a new Q&A document, Questions & Answers – Working with Microorganisms Developed Using Genetic Engineering Under 7 CFR part 340, which covers topics including what microorganisms are regulated, permit requirements, permit exemptions, how to contact APHIS and what information to provide if you are uncertain if a microorganism is regulated. The second is the updated Confirmation Request Guidance which 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 APHIS treats off-target modifications when considering confirmation requests.

For additional questions regarding the regulation of modified microorganisms, email biotechquery@usda.gov. For questions regarding Confirmation Requests, email BRS.ConfirmationRequest@usda.gov.