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(a) Microorganism and significant new uses subject to reporting.(1) The genetically-modified microorganism identified generically as arsenic detecting strain of E. coli with extra-chromosomal elements, including an intergeneric screening marker (MCAN J-18-41) 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 (excluding import) the microorganism in the United States for any use.
(ii) It is a significant new use to use the microorganism other than to detect arsenic in small water samples.
(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.
[86 FR 24336, May 6, 2021]