Regulatory status review.

CFR · 2024-01-01 · US · Title 7

(a)(1) Any person may submit a request to APHIS for a regulatory status review, pursuant to paragraph (b)(3) of this section. (2) Any person may request re-review of a GE plant previously found to be subject to this part after an initial review was conducted, provided that the request is supported by new, scientifically valid evidence bearing on the plant pest risk associated with movement of the plant. (3) APHIS may also initiate a regulatory status review or re-review of a GE plant to identify whether it is subject to regulation under this part. (4) Information submitted in support of a request for a regulatory status review or re-review must meet the requirements listed in paragraphs (a)(4)(i) through (iii) of this section. (i) A description of the comparator plant(s), to include genus, species, and any relevant subspecies information; (ii) The genotype of the modified plant, including a detailed description of the differences in genotype between the modified and unmodified plant; and (iii) A detailed description of the new trait(s) of the modified plant. (iv) Detailed information on how to meet the above-listed requirements can be found on the APHIS website at (b)(1) When APHIS receives a request for a regulatory status review of a GE plant, APHIS will conduct an initial review to determine whether there is a plausible pathway by which the GE (i) The biology of the comparator plant(s) and its sexually compatible relatives; (ii) The trait and mechanism-of-action of the mod

official document · source cfr-2024 · id 7:§ 340.4