(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).