§174.91 Submitting a letter of self-determination.

To self-determine eligibility for the exemption of a plant-incorporated protectant listed under §174.90(a)(2), a developer must comply with all of the following requirements.

(a) When to submit a letter of self-determination. A letter of self-determination for an exemption must be submitted to EPA prior to engaging in any activity that would be subject to FIFRA absent an exemption.

(b) Contents of a letter of self-determination. The letter of self-determination must:

(1) Provide the name and contact information for the submitter (including telephone number and email address), company name, or other affiliation.

(2) Identify the plant-incorporated protectant by providing: the identity of the recipient plant (genus and species), a unique identifier for the native gene from the National Center for Biotechnology Information (NCBI) at the National Library of Medicine of the National Institutes of Health (NLM) at the National Institutes of Health (NIH) ( i.e., Entrez GeneID), the trait type ( e.g., insect resistance), and cite the paragraph under §174.90(a)(2) that indicates that the plant-incorporated protectant is eligible for self-determination.

(3) Complete and submit the certification statement provided in the electronic submission portal. The statement must be dated and signed by the certifying official identified in the certification statement.

(c) EPA response. EPA will provide electronic confirmation of receipt immediately. Electronic confirmation of receipt shall be equivalent to written confirmation of receipt.

(d) Effective date of exemption. The exemption does not apply until EPA confirms receipt of the letter of self-determination.

[88 FR 34777, May 31, 2023]