(a) Options for determining eligibility. As required in §§ 174.21(d) and 174.541(c), the developer must notify EPA to be eligible for exemption. Available notification options differ by plant-incorporated protectant. The developer must do at least one of the following:

(1) EPA confirmation. Unless permitted in paragraph (a)(2) of this section, a developer must submit a request for EPA confirmation of eligibility in accordance with § 174.93. Any developer may submit a request for EPA confirmation of eligibility in accordance with § 174.93.

(2) Self-determination. A developer may submit a letter of self-determination in accordance with § 174.91 if the plant-incorporated protectant qualifies for exemption as one of the following:

(i) A loss-of-function plant-incorporated protectant eligible for exemption under § 174.27.

(ii) [Reserved]

(b) Where to submit a request for EPA confirmation or letter of self-determination. A request for EPA confirmation of eligibility or a letter of self-determination must be submitted electronically.

(c) Claims of confidentiality. Any claims of confidentiality for information submitted in the request for EPA confirmation or a letter of self-determination must be made in accordance with the procedures outlined in § 174.9.

(d) Overlapping determinations of eligibility. If a plant-incorporated protectant is eligible for a self-determination option, a developer may elect to submit a letter of self-determination as well as a request for EPA confirmation of eligibility concurrently or at a later time. If the developer so elects, the letter of self-determination will remain in effect while EPA evaluates the request for confirmation of eligibility.

(e) Revisiting eligibility determination. If, at any time after EPA issues a confirmation of eligibility or the letter of self-determination is submitted, EPA becomes aware of information indicating that a plant-incorporated protectant no longer meets the criteria for exemption (e.g., adverse effects reports submitted under § 174.71) or that the self-determination was incorrect, EPA will generally notify the submitter in writing of EPA's intention to initiate a review of eligibility for exemption and may request additional information from the submitter in order to evaluate that eligibility for exemption. Upon conclusion of its review, EPA will notify the submitter in writing of its determination as to whether the plant-incorporated protectant meets the exemption criteria and any actions that will be required should the plant-incorporated protectant be found to not meet the exemption criteria. Under those circumstances, the plant-incorporated protectant may be considered to be noncompliant with FIFRA and subject to possible enforcement by EPA. At any time, if EPA finds or has reason to believe that a plant-incorporated protectant's non-compliance with FIFRA requires immediate action, EPA may take such action, including enforcement, without first informing the submitter of an eligibility review.

(f) Extension of exemption. An exemption can be extended in one of two ways. First, if the exempted plant-incorporated protectant is moved through conventional breeding to other plants, the exemption is extended to the subsequent plant-incorporated protectant. Second, to extend the exemption of the plant-incorporated protectant to subsequent genetic engineering events in other plants, the following exemption-specific criteria apply:

(1) Plant-incorporated protectant created through genetic engineering from a sexually compatible plant. An exemption extends to a plant-incorporated protectant when that plant-incorporated protectant is genetically engineered by the submitter into another variety of that same plant species, the substance produced is identical to the substance produced in the original recipient plant, and no new modifications were made to the regulatory regions.

(2) Loss of function plant-incorporated protectant. An exemption extends to a plant-incorporated protectant when that plant-incorporated protectant is genetically engineered by the submitter into another variety of that same plant species and the same native gene is targeted to create the loss-of-function PIP.

(g) No duplication necessary. A developer is not required to submit duplicative requests for eligibility determination or self-determination under both §§ 174.541(c) and 174.21(d), if it has already been submitted for purposes of determining eligibility under § 174.21(d).

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.

To request EPA confirmation of eligibility for exemption of a plant-incorporated protectant listed under § 174.21(d), a developer must comply with all of the following requirements.

(a) When to submit a request for EPA confirmation. Unless the developer has received confirmation of receipt of a letter of self-determination, the request for EPA confirmation must be submitted prior to engaging in any activity that would be subject to FIFRA absent an exemption.

(b) Contents of a request for EPA confirmation of exemption eligibility. The request must contain information as specified in § 174.91(b) and supporting documentation, as specified in exemption-specific sections of this subpart (e.g., § 174.95).

(c) EPA review and response. Upon receipt of a request, EPA will review and evaluate the information provided to determine whether the plant-incorporated protectant meets the exemption criteria in § 174.21. EPA may require additional information to assess whether a plant-incorporated protectant meets the criteria for exemption. EPA will notify the submitter in writing of its determination. If EPA determines that the plant-incorporated protectant does not meet the criteria for exemption, EPA will notify the submitter in writing of any actions that will be required.

(d) Effective date of exemption. If the plant-incorporated protectant is not already exempt pursuant to the self-determination process under § 174.91, this exemption applies once EPA notifies the submitter in writing, confirming that the plant-incorporated protectant meets the criteria for exemption.

A developer requesting EPA confirmation of exemption eligibility for a plant-incorporated protectant created through genetic engineering from a sexually compatible plant pursuant to § 174.93 must submit the information in the following paragraphs to EPA. The following documentation must be maintained by a developer of a plant-incorporated protectant created through genetic engineering from a sexually compatible plant per § 174.73:

(a) Biology of the plant. (1) The identity of the recipient plant, including genus and species.

(2) If the plant-incorporated protectant was derived from a plant species other than the recipient plant species, provide the identity of the source plant including genus and species and information to support the determination that the recipient plant and the source plant are sexually compatible (e.g., through peer-reviewed literature rationale).

(b) Description of the pesticidal trait and how the trait was engineered into the plant. Include a description of the measures that were taken to ensure that no engineering components (e.g., Cas proteins) are present in the final plant product and the measures taken to maximize the likelihood that the modification to the recipient plant is limited to the intended modification.

(c) Molecular characterization of the plant-incorporated protectant. A nucleic acid sequence comparison of the plant-incorporated protectant between the recipient plant and the comparator(s). A deduced amino acid sequence comparison is additionally required when the pesticidal substance is proteinaceous. The relevant comparator(s) for the sequence comparison(s) are determined by the type of modification:

(1) For § 174.26(a)(1), sequences in the source plant and in the recipient plant.

(2) For § 174.26(a)(2), sequences in the recipient plant before the modification, after the modification, and the sequence in the source plant. The polymorphic site(s) must be indicated.

(d) Information on the history of safe use of the plant-incorporated protectant. (1) If the pesticidal substance is a known allergen or mammalian toxin/toxicant (e.g., solanine), describe how conventional breeding practices are being used to ensure that it does not exceed human dietary safety levels in the recipient food plant (i.e., ensure residues of pesticidal substance are not present in food at levels that are injurious or deleterious and are within the ranges of levels generally seen in plant varieties currently on the market and/or known to produce food safe for consumption).

(2) If the source plant is a wild relative of the recipient plant, describe why the plant-incorporated protectant is not anticipated to pose a hazard to humans or the environment (e.g., Are levels of the pesticidal substance produced in the recipient plant within the ranges of levels generally seen in plant varieties currently on the market and/or known to produce food safe for consumption? Is the pesticidal mode of action non-toxic? Does the plant-incorporated protectant lack sequence similarity to known mammalian toxins, toxicants, or allergens? Is the plant-incorporated protectant a commonly screened substance and therefore familiar to plant breeders?).

A developer requesting EPA confirmation of exemption eligibility for a loss-of-function plant-incorporated protectant pursuant to § 174.93 must submit the information in the following paragraphs to EPA along with the developer's request for exemption confirmation. The following documentation must be maintained by a developer of a loss-of-function plant-incorporated protectant per § 174.73:

(a) Biology of the plant: The identity of the recipient plant, including genus and species.

(b) Description of the pesticidal trait that results from the loss-of-function and how the trait was engineered into the plant. Include a description of the steps that were taken to ensure that no engineering components (e.g., Cas proteins) remain in the plant and the measures taken to maximize the likelihood that the modification to the recipient plant is limited to the intended modification.