['Toxic Substances Control Act - EPA']
['Toxic Subtances Control Act - EPA', 'Chemical Data Reporting']
08/29/2023
Copyright 2024 J. J. Keller & Associate, Inc. For re-use options please contact copyright@jjkeller.com or call 800-558-5011.
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(a) Representative subset and selection of submissions for review. (1) A representative subset consists of at least 25 percent of confidentiality claims asserted under TSCA, not including claims for specific chemical identity or for the categories of information listed in section 14(c)(2) of the Act. Excluded from the representative subset are:
(i) Inquiries with respect to potential submission to EPA of a notification under 40 CFR part 720, 721, 723, or 725 by a person who has not submitted the notification at the time of the inquiry, including inquiries under §720.25(b) or §721.11 of this subchapter;
(ii) Submissions or other communication not submitted to EPA via CDX; and
(iii) Amendments to previous TSCA submissions.
(2) To satisfy its confidentiality claim review obligations under section 14(g)(1)(C)(ii) of the Act, EPA will generally review all claims (except those exempt from substantiation under section 14(c)(2) of the Act) in every fourth TSCA submission submitted via CDX that is part of the representative subset, in chronological order of receipt by EPA. For each submission selected for review as part of the representative subset, EPA reviews and approves or denies every individual confidentiality claim in that submission (except claims that are exempt under sections 14(c)(2) and 14(g) of the Act), including claims made in attachments and amendments available to EPA at the time of the review.
(b) Review of new and expiring confidentiality claims under TSCA Section 14(g). (1)(i) Under section 14(g) of the Act, EPA will review:
(A) All chemical identity claims asserted in TSCA submissions except those that are exempt from substantiation according to section 14(c)(2)(G) of the Act; and
(B) a representative subset of other confidentiality claims as provided in paragraph (a) of this section.
(ii) Final determinations will be issued by the General Counsel or their designee, which may include personnel outside of the Office of General Counsel.
(2) EPA will review all timely requests for extension of claims under section 14(e) of the Act within 30 days of receipt.
(3) EPA will also review or re-review confidentiality claims under certain other circumstances, as set out in section 14(f) of the Act. Review under section 14(f) of the Act are conducted in accordance with procedures set out in §703.8.
(c) Commencement of the review period and effect of amendments. Subject to §703.5(e), the 90-day review period described in section 14(g) of the Act begins on the day that EPA accepts a new TSCA submission that includes confidentiality claims. For new information, other than specific chemical identity, added to a submission after EPA first accepts the submission, the review will take into account such amendments to that submission that are made either up to 60 days from the original submission date, or until the Agency issues a final confidentiality determination for the submission, whichever comes first. If a submission is amended to report an additional or different chemical substance that includes a new specific chemical identity claim, the TSCA section 14(g) review period for the added chemical identity begins on the day EPA accepts the amendment including the new claim.
(d) Publication of final determinations. Final confidentiality determinations will be published on EPA's website, or other platform, periodically, in accordance with the requirements of section 26(j) of the Act.
(e) Claim denials and notice period. In the case that EPA determines that a claim or part of a claim is not entitled to confidential treatment, EPA will provide notice of the denial to the person who made the claim and provide reasons for the denial or denial in part. The notice will be provided, as described in §703.5(h). The 30-day notice period described in section 14(g)(2)(B) of the Act begins on the next business day following the date the notice is made available to the submitter in their CDX account.
(f) Substantive criteria for use in confidentiality determinations. Information claimed as confidential under section 14 of the Act will be approved if all of the following apply:
(1) The business has asserted a business confidentiality claim which has not expired by its terms, nor been waived nor withdrawn;
(2) The business has satisfactorily shown that it has taken reasonable measures to protect the confidentiality of the information, and that it intends to continue to take such measures for as long as the claim is maintained;
(3) The information is not, and has not been, reasonably obtainable without the business's consent by other persons (other than governmental bodies) by use of legitimate means (other than discovery based on a showing of special need in a judicial or quasi-judicial proceeding; e.g., the business has demonstrated a reasonable basis to believe the information is not readily discoverable through reverse engineering);
(4) The business has demonstrated a reasonable basis to conclude that disclosure of the information is likely to cause substantial harm to the competitive position of the business; and
(5) No statute denies confidential protection to the information. Information from health and safety studies respecting any chemical that has been offered for commercial distribution or for which testing is required under section 4 of the Act or notice is required under section 5 of the Act is not entitled to confidential treatment, except that the following information may be entitled to confidential treatment if it otherwise meets the remainder of criteria in this paragraph (f):
(i) Any information, including formulas (including molecular structures) of a chemical substance or mixture, that discloses processes used in the manufacturing or processing of a chemical substance or mixture; or
(ii) In the case of a mixture, the portion of the mixture comprised by any of the chemical substances in the mixture.
(6) The business adequately demonstrates that the information is commercial or financial information obtained from a person and is confidential within the meaning of FOIA Exemption 4 (5 U.S.C. 552(b)(4)).
(g) Criteria to use in consideration of requests for extension under TSCA section 14(e). Requests to extend the period of confidentiality protection under TSCA section 14(e) will be evaluated using the same criteria as described in paragraph (f) of this section. Requests for extension may rely on a substantiation previously provided to EPA, but the submitter must recertify that the substantiation is still true and correct.
[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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Copyright 2024 J. J. Keller & Associate, Inc. For re-use options please contact copyright@jjkeller.com or call 800-558-5011.