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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 as Trichoderma reesei strain 3CH-3 (MCAN J-19-1) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.
(2)
(i) The significant new use is any manufacturing, processing, or use of 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 further fermentation, such as saccharification (i.e., addition of Trichoderma reesei fermentation broth to solid plant material or insoluble substrate 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 A of this part apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a) though (c) and (i) of this chapter, are applicable to manufacturers and processors of this substance.
(2) Limitations or revocation of certain notification requirements. The provisions of § 721.185 of this chapter apply to this section.
[86 FR 22875, Apr. 30, 2021]