§ 174.21 General qualifications for exemptions.

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.

[88 FR 34776, May 31, 2023]