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15 U.S.C. 2604, 2607, 2613, and 2625.
62 FR 17932, Apr. 11, 1997, unless otherwise noted.
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(a) Microorganism and significant new uses subject to reporting.
(1) The genetically-modified microorganism identified generically as microorganism expressing enzymes (MCAN J-23-3) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) It is a significant new use to manufacture, process, or use the microorganism other than in a fermentation system that meets all of the following conditions:
(A) Enzyme production occurs by submerged fermentation (i.e., for enzyme production, growth of the microorganism occurs beneath the surface of the liquid growth medium); and
(B) Any fermentation of solid plant material or insoluble substrate to which the microorganism fermentation broth is added after the standard industrial fermentation is completed is initiated only after the inactivation of the microorganism as delineated in § 725.422(d).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart L of this part apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in § 725.950(b)(2) through (4) are applicable to manufacturers and processors of this microorganism.
(2) Modification or revocation of certain notification requirements. The provisions of § 725.984 apply to this section.
[90 FR 35638, July 29, 2025]