§ 340.4 Regulatory status review. ( 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 *https://www.aphis.usda.gov/aphis/ourfocus/biotechnology .* If APHIS proposes revisions to the detailed information on the APHIS website, APHIS will make the proposed revisions available for notice and public comment prior to implementation.
( 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 plant, or any sexually compatible relatives that can acquire the engineered trait from the GE plant, would pose an increased plant pest risk relative to the plant pest risk posed by the respective non-GE or other appropriate comparator(s), based on the following factors: ( i ) The biology of the comparator plant(s) and its sexually compatible relatives;
( ii ) The trait and mechanism-of-action of the modification(s); and
( iii ) The effect of the trait and mechanism-of-action on: ( A ) The distribution, density, or development of the plant and its sexually compatible relatives;
( B ) The production, creation, or enhancement of a plant pest or a reservoir for a plant pest;
( C ) Harm to non-target organisms beneficial to agriculture; and
( D ) The weedy impacts of the plant and its sexually compatible relatives.
( 2 ) APHIS will complete the initial review within 180 days of receiving a request for a regulatory status review that meets the requirements specified in paragraph (a)(4) of this section, except in circumstances that could not reasonably have been anticipated. If APHIS does not identify a plausible pathway by which the GE plant or its sexually compatible relatives would pose an increased plant pest risk relative to the comparator(s) in the initial review, the GE plant is not subject to the regulations in this part. APHIS will post the plant, trait, and general description of the MOA on its website. (b)(3)(i) If APHIS does identify a plausible pathway by which the GE plant or its sexually compatible relatives would pose an increased plant pest risk relative to the comparator(s) in the initial review, the requestor may apply for a permit and/or request that APHIS conduct an evaluation of the factor(s) of concern identified in the initial review to determine the likelihood and consequence of the plausible increased plant pest risk. APHIS may request additional information as needed to evaluate the factor(s) of concern. ( ii ) For those GE plants for which such an evaluation is conducted, APHIS will publish the results of the evaluation in the Federal Register and will solicit and review comments from the public. Except in circumstances that could not reasonably have been anticipated, APHIS will complete these steps within 15 months of receiving a request for a regulatory status review that meets the requirements specified in paragraph (a)(4) of this section.
( iii ) If APHIS finds that the GE plant and its sexually compatible relatives are unlikely to pose an increased plant pest risk relative to their comparator(s), the GE plant is not subject to this part. APHIS will publish its evaluation of the plant-trait-MOA combination in a subsequent Federal Register document and will also post it on the APHIS website. If APHIS does not make such a finding, the GE plant will remain regulated under this part, and its movement will be allowed only under permit in accordance with § 340.5.
( c ) This section is applicable beginning April 5, 2021 for GE corn, soybean, cotton, potato, tomato, and alfalfa, and on October 1, 2021 for all GE plants.
(Approved by the Office of Management and Budget under control number 0579-0471)