Am I Regulated Under 7 CFR part 340?

Am I Regulated Under 7 CFR part 340?

Regulated Article Letter of Inquiry Submission Process

Biotechnology Regulatory Services 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, which can be read at /brs/pdf/7cfr340.pdf.

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, you may seek a determination from BRS by sending a signed letter with the information below to:

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

Your letter should include:

  • Transformation method (e.g. biolistic transformation or disarmed Agrobacterium)
  • Construct - For each element in a construct, in the order in which they occur in the construct, provide the following information:
    • element type (e.g., promoter, gene, terminator)
    • name of the element (e.g., 35S, extensin, catalase)
    • the organism from which the element is derived (species or virus strain)
    • a brief description of the element's function
  • Recipient organism - Genus, species, and subspecies designation if relevant of the organism that was transformed.
  • Donor organisms - Describe the donors for any and all DNA sequences in the construct that were actually inserted into the plant (includes promoters, genes of interest, terminators, introns, etc).
  • Trait - Describe the intended phenotype.
  • Your name and contact information, including email address.

Indicate in your letter whether it contains confidential business information (CBI). If it does, include a redacted version of your letter as well. You will receive verification that your letter has been received, and what the next steps will be.

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

Regulated Letters of Inquiry

For Additional Information
If you require further assistance, please contact a BRS biotechnologist by sending your questions to


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