(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]