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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

The Plant Protection Act (PPA) authorizes the Animal and Plant Health Inspection Service (APHIS) to protect plant health in the United States.  Under that authority, APHIS currently regulates certain genetically engineered organisms (GE) that may present a plant health risk.  Biotechnology Regulatory Services provides the regulatory oversight of certain 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 under the regulations at 7 CFR part 340. The definition of a regulated article is found at 7 CFR § 340.1.  In addition, BRS coordinates and works with other programs in APHIS, the Environmental Protection Agency and the Food and Drug Administration consistent with the principles of the Coordinated Framework for the Regulation of Biotechnology to ensure protection of plant health, the environment and food safety.

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 an authorization (permit or notification) before proceeding with the activity.

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 introduction, you may seek a confirmation of regulatory status of the GE organism from BRS by sending a signed letter containing the information described below to:

Address the letter of inquiry to:

Dr. Michael J. Firko
APHIS Deputy Administrator
Biotechnology Regulatory Services
4700 River Rd, Unit 98
Riverdale, MD 20737

Send the letter of inquiry to: 

Ms. Cynthia A. Eck
Document Control Officer
Biotechnology Regulatory Services
4700 River Rd, Unit 146
Riverdale, MD 20737 

OR

AIRinquiry@aphis.usda.gov

Your letter of inquiry should include:

• Developer name and contact information, including email address.
• • Foreign developers must submit the inquiry through a US entity.
• Taxonomic description of organism (genus, species, and subspecies, if relevant).
• Description of intended phenotype.
• Description of intended activity (movement or release).
• Description of intended genetic change in final product (e.g., insertion, deletion, substitution).
• Description of vector or vector agent used to induce genetic change in the organism (e.g., biolistic delivery, disarmed Agrobacterium, nuclease).
• Name of construct
• Description of construct, including the following information for all elements, in order in which they occur in construct:
• Element type (e.g., operators, promoters, origins of replication, terminators, ribosome binding regions);
• Element name (e.g., 35S, extensin, catalase);
• Organism from which element is derived (species or virus strain); and
• Brief description of genetic element’s function. 

If your letter of inquiry contains confidential business information (CBI), you must submit a CBI version, a CBI-deleted version and a CBI justification.  We will not initiate the review of your inquiry until we have received all of the required documents.  Please consult the two links below for instructions for preparing these required documents. You will receive verification that your letter of inquiry has been received.

BRS User’s Guide: General Document Preparation Guidelines for Submission to BRS

Instructions for Confidential Business Information (CBI) Justification

To view previous letters of inquiry and APHIS' response, click the link below:

Am I Regulated Letters of Inquiry

For Additional Information
If you require further assistance, please contact BRS by sending your questions to AIRinquiry@aphis.usda.gov.