• Biotechnology (BRS)
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• "Am I Regulated?" Process

Am I Regulated Under 7 CFR part 340?

Submission Process for Am I Regulated Letters of Inquiry

USDA provides oversight of certain genetically engineered (GE) organisms to protect plant health, by regulating the introduction—meaning the importation, interstate movement, and environmental release—of those GE organisms that may pose a pest risk to plants. The definition of a regulated article is found at 7 CFR § 340.1.

If your GE organism meets the definition of a regulated article and you plan to import it, move it interstate or release it into the environment, you will need to apply for a permit or notification.

If you are unsure whether your GE organism meets the definition of a regulated article as described in 7 CFR part 340, prior to proceeding with an application for a permit or notification, you may seek a confirmation of regulatory status of the GE organism from USDA.  Please follow the instructions in our Guidance for Submission of Am I Regulated Inquiries.

View BRS Guidance for Submission of Am I Regulated Inquiries

View AIR Letters of Inquiry and APHIS Responses

For Additional Information

If you require further assistance, please contact BRS by sending your questions to: AIRinquiries@usda.gov.