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?).