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15 U.S.C. 2607(a) and (b).
85 FR 13068, Mar. 6, 2020, unless otherwise noted.
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(a) Who must substantiate. Any person who filed a Notice of Activity Form A requesting to maintain an existing confidentiality claim for a specific chemical identity must substantiate that confidentiality claim as specified in §§ 710.45 and 710.47 unless eligible for an exemption in paragraph (b) of this section.
(b) Exemptions.
(1) Any person who completed the voluntary substantiation process set forth in § 710.37(a)(1) is exempt from the substantiation requirement of this subpart pertaining to the submission of answers to the questions in § 710.45(b)(1) through (6). All remaining requirements of § 710.45 must be met in accordance with the deadline specified in § 710.47(a), including the requirement to submit answers to the questions in § 710.45(b)(7) and (8), signed and dated by an authorized official, and to complete the certification statement in § 710.37(e).
(2) A person who has previously substantiated the confidentiality claim for a specific chemical identity that the person requested to maintain in a Notice of Activity Form A, by submitting information that is responsive to all questions in § 710.45, is exempt from the substantiation requirement of this subpart if both of the following conditions are met:
(i) The previous substantiation was submitted to EPA on or after November 1, 2015; and
(ii) The person reports to EPA the submission date, submission type, and case number, transaction ID, or equivalent identifier for the previous submission that contained the substantiation, not later than the deadline specified in § 710.47.