A plant-incorporated protectant is exempt from the requirements of FIFRA, other than the requirements of § 174.71, if it meets the exemption criteria in paragraphs (a) through (d) of this section. Plant-incorporated protectants that are not exempt from the requirements of FIFRA under this subpart are subject to all the requirements of FIFRA.

(a) The active ingredient of the plant-incorporated protectant meets the exemption criteria listed in at least one of the sections in §§ 174.25 through 174.50.

(b) When the plant-incorporated protectant is intended to be produced and used in a crop used as food, the residues of the active ingredient of the plant-incorporated protectant are either exempted from the requirement of a tolerance under FFDCA (21 U.S.C. 321 et seq.) as listed in subpart W of this part, or no tolerance would otherwise be required.

(c) Any inert ingredient that is part of the plant-incorporated protectant is listed as an approved inert ingredient in subpart X of this part.

(d) For plant-incorporated protectants listed in the subparagraphs below, the exemption applies only if the developer is compliant with the general recordkeeping requirements specified in § 174.73 per sections 8 and 9 of FIFRA, 7 U.S.C. 136f and 136g, and only after compliance with the relevant eligibility determination procedures specified in § 174.90:

(1) Plant-incorporated protectant created through genetic engineering from a sexually compatible plant.

(2) Loss-of-function plant-incorporated protectant.

The active ingredient is exempt if all of the following conditions are met:

(a) The genetic material that encodes the pesticidal substance or leads to the production of the pesticidal substance is from a plant that is sexually compatible with the recipient plant.

(b) The genetic material has never been derived from a source that is not sexually compatible with the recipient plant.

(c) The genetic material is transferred from the source plant to the recipient plant only through conventional breeding.

The active ingredient is exempt if the conditions in paragraphs (a) and (b) of this section are met.

(a) The active ingredient is characteristic of the population of plants sexually compatible with the recipient plant and is created through genetic engineering from either an insertion of a native gene into the recipient plant as specified in paragraph (a)(1) of this section or a modification of an existing native gene in the recipient plant as specified in paragraph (a)(2) of this section.

(1) Insertion. A native gene is inserted into the genome of the recipient plant and produces a pesticidal substance identical in sequence to the pesticidal substance identified in the source plant. The regulatory regions inserted as part of the native gene must be identical in nucleic acid sequence to those regulatory regions of the native gene identified in the source plant.

(2) Modification. The existing native gene is modified to match corresponding polymorphic sequence(s) in a native allele of that gene using a single source plant as a template.

(b) This exemption does not apply until the requirements in § 174.21(d) have been met.

The active ingredient is exempt if the following conditions are met:

(a) The genetic material of a native gene is modified using genetic engineering to result in a pesticidal effect through the reduction or elimination of the activity of that gene; and

(b) This exemption does not apply until the requirements in § 174.21(d) have been met.