['Toxic Substances Control Act - EPA']
['Toxic Subtances Control Act - EPA', 'Chemical Data Reporting']
08/29/2023
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(a) Review of confidentiality claims initiated under TSCA Section 14(f). In accordance with the procedures described in this section, EPA may review confidentiality claims where authorized by TSCA section 14(f)(1), and will review confidentiality claims subject to TSCA section 14(f)(2) in the following situations:
(1) In response to a request under the Freedom of Information Act (5 U.S.C. 552) for TSCA information claimed confidential;
(2) If EPA has reason to believe that information claimed confidential does not qualify for protection from disclosure; or
(3) For any chemical substance which EPA determines under TSCA section 6(b)(4)(A) presents an unreasonable risk of injury to health or the environment.
(b) Substantiation exemptions not applicable. The exemptions from substantiation requirements contained in section 14(c)(2) of TSCA do not apply to confidentiality claims reviewed under this section 703.8, even if such exemptions applied when the information was originally submitted to EPA.
(c) Additional substantiation. If necessary, such as where substantiation has not previously been provided for confidentiality claims under review, or where EPA has reason to believe the substantiation is incomplete or out of date, EPA will request additional substantiation from the person(s) that claimed the information as confidential.
(d) Additional substantiation notice. If additional substantiation is necessary, EPA will provide notice to the person that claimed the information as confidential in the manner specified in §703.5(h)(4). The notice will provide the time allowed for additional substantiation from the business and the method for requesting a time extension if necessary. If the person does not make a timely response or extension request, EPA will consider any existing substantiations in its review of the claims or, in the case of any unsubstantiated claim, EPA will construe this as a waiver of the claim and may make the information public without any further notice to the submitter.
(e) Substantive criteria for use in confidentiality determinations. The criteria in §703.7(f) apply to confidentiality determinations initiated under TSCA section 14(f).
(f) Adverse determinations and notice period. Final determinations will be issued by the General Counsel or their designee, including personnel outside of the Office of General Counsel. Except for instances where claims were waived, if EPA determines that information claimed confidential does not qualify for protection from disclosure, EPA will provide written notice to the person who asserted the claim. The notice will be provided electronically, as described in §703.5(h)(2). The 30-day notice period described in TSCA section 14(g)(2)(B) begins on the next business day following the date the notice is made available to the submitter in their CDX account.
(g) Disclosure of Information. After a final determination has been made by EPA to release some or all of the information claimed as confidential, the Agency shall make the information available to the public (in the absence of a court order prohibiting disclosure) whenever:
(1) The period provided for commencement by a business of an action to obtain judicial review of the determination has expired without notice to EPA of commencement of such an action; or
(2) The court, in a timely-commenced action, has denied the person's motion for a preliminary injunction, or has otherwise upheld the EPA determination.
(h) Notice relating to public requests for records. Any person whose request for release of the information under 5 U.S.C. 552 is pending at the time notice is given under paragraph (f) of this section shall be furnished notice under 5 U.S.C. 552 either stating the circumstances under which the some or all of the information will be released or denying the request if all requested information was found to be entitled to confidential treatment.
[88 FR 37166, June 7, 2023]
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['Toxic Substances Control Act - EPA']
['Toxic Subtances Control Act - EPA', 'Chemical Data Reporting']
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