Applicability of this part.

CFR · 2024-01-01 · US · Title 7

(a) The regulations in this part apply to those organisms described in § 340.2, but not to any organism that is exempt from this part under paragraph (b), (c), or (d) of this section. (b) The regulations in this part do not apply to plants that have been modified such that they contain either a single modification of a type listed in paragraphs (b)(1) through (3) of this section, or additional modifications as determined by the Administrator, and described in paragraph (b)(4) of this section. (1) The genetic modification is a change resulting from cellular repair of a targeted DNA break in the absence of an externally provided repair template; or (2) The genetic modification is a targeted single base pair substitution; or (3) The genetic modification introduces a gene known to occur in the plant's gene pool, or makes changes in a targeted sequence to correspond to a known allele of such a gene or to a known structural variation present in the gene pool. (4) The Administrator may propose to exempt plants with additional modifications, based on what could be achieved through conventional breeding. Such proposals may be Agency-initiated, and follow the process in paragraph (b)(4)(i) of this section, or in response to a request made in accordance with paragraph (b)(4)(ii) of this section. (i) (ii) (A) A description of the modification(s); (B) The factual grounds demonstrating that the proposed modification(s) could be achieved through conventional plant breeding; (C) Copies of sc

official document · source cfr-2024 · id 7:§ 340.1