cfr_sections
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5 rows where part_number = 703 and title_number = 40 sorted by section_id
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| section_id ▼ | title_number | title_name | chapter | subchapter | part_number | part_name | subpart | subpart_name | section_number | section_heading | agency | authority | source_citation | amendment_citations | full_text |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 40:40:33.0.1.1.3.0.1.1 | 40 | Protection of Environment | I | R | 703 | PART 703—CONFIDENTIALITY CLAIMS | § 703.1 Purpose and applicability. | EPA | (a) The purpose of this part is to describe procedures for asserting and maintaining confidentiality claims in accordance with TSCA section 14, and for EPA review of such claims. The procedures described in this part are generally applicable to the submission and EPA review of any TSCA submission, except to the extent that application of the requirements would be inconsistent with TSCA section 14(i). The procedures include requirements concerning the form and manner in which TSCA submissions must be made to meet requirements in TSCA sections 14(b) and (c), to facilitate EPA review of such claims in accordance with TSCA sections 14(f) and (g), and to facilitate disclosure of non-confidential information to the public in accordance with TSCA, FOIA, and their implementing regulations. (b) This part applies to all information that is reported to or otherwise obtained by EPA pursuant to TSCA or its implementing regulations. This includes information that was first obtained by EPA other than pursuant to the authority of TSCA or its implementing regulations, provided that the following two criteria have been met: (1) EPA has authority to collect the information under TSCA; and (2) Either: (i) Subsequent to its submission the information is being used to satisfy the obligation of a person under TSCA or its implementing regulations; or (ii) EPA makes use of the information in the course of carrying out its responsibilities under TSCA (e.g., EPA considered such information in its actions under TSCA sections 4, 5, or 6). (c)(1) This part applies regardless of the following: (i) Whether the information is intended by its submitter to be used by EPA in implementing TSCA; (ii) Whether TSCA or an implementing regulation was cited as authority for the request or submission of the information; or (iii) Whether the information was provided directly to EPA or through some third person. (2) However, where such information is not protected from disclosure under TSCA Section 14, but the statute under which the information wa… | ||||||
| 40:40:33.0.1.1.3.0.1.2 | 40 | Protection of Environment | I | R | 703 | PART 703—CONFIDENTIALITY CLAIMS | § 703.3 Definitions. | EPA | [88 FR 37166, June 7, 2023, as amended at 89 FR 102789, Dec. 18, 2024] | The definitions in this section and the definitions in TSCA section 3 apply to this part. In addition, the definition in § 720.3; of this subchapter for test data also applies in this part. Accept in the context of asserting a TSCA CBI claim means EPA's first approval of the submission containing the CBI claim in CISS, or its successor system. Act, or TSCA, means the Toxic Substances Control Act, 15 U.S.C. 2601 et seq. CDX or Central Data Exchange means EPA's centralized electronic document receiving system, or its successor system. CISS or Chemical Information Submission System means EPA's web-based reporting tool for preparing and submitting TSCA submissions, or its successor system. Confidentiality claim means a claim or allegation that business information is entitled to confidential treatment. FOIA means the Freedom of Information Act, 5 U.S.C. 552, et seq. Health and safety study has the same meaning as that provided in § 720.3 of this subchapter, except that for purposes of this part 703 the following information is not part of a health and safety study: (1) The name, address, or other identifying information for the submitting company, including identification of the laboratory that conducted the study in cases where the laboratory is part of or closely affiliated with the submitting company. (2) Internal product codes ( i.e., code names for the test substance used internally by the submitting company or to identify the test substance to the test laboratory). (3) Names and contact details for testing laboratory personnel and names and other private information for health and safety study participants or persons involved in chemical incidents such as would typically be withheld under 5 U.S.C. 552(b)(6) or under other privacy laws. (4) Information pertaining to test substance product development, advertising, or marketing plans, or to cost and other financial data. | |||||
| 40:40:33.0.1.1.3.0.1.3 | 40 | Protection of Environment | I | R | 703 | PART 703—CONFIDENTIALITY CLAIMS | § 703.5 Requirements for asserting and maintaining confidentiality claims. | EPA | Any person who submits information under TSCA or these implementing regulations may assert a business confidentiality claim to information included in such submission except where such a claim is disallowed by applicable regulation under this subchapter. Such claim must be made concurrent with submission of the information. If no such claim accompanies the submission, EPA will not recognize a confidentiality claim, and the information in or referred to in that submission may be made available to the public (e.g., by publication of specific chemical name and CASRN on the public portion of the TSCA Inventory) without further notice. (a) Supporting statement and certification. (1) A person asserting a confidentiality claim must submit a statement that the person has: (i) Taken reasonable measures to protect the confidentiality of the information; (ii) Determined that the information is not required to be disclosed or otherwise made available to the public under any other Federal law; (iii) A reasonable basis to conclude that disclosure of the information is likely to cause substantial harm to the competitive position of the person; and (iv) A reasonable basis to believe that the information is not readily discoverable through reverse engineering. (2) The person must also certify that these four statements and any information required to substantiate the confidentiality claim in accordance with paragraph (b) of this section are true and correct. (b) Substantiation. (1) Confidentiality claims must be substantiated at the time of submission to EPA, unless exempt under paragraph (b)(5) of this section. In the case of information collected by EPA or on behalf of EPA in person at the site of a TSCA inspection under section 11 of the Act, the affected company must assert its confidentiality claim(s) in writing at the time the information is collected, and then must provide substantiation of its confidentiality claims and the supporting statement and certification described in paragraph (a) of this section within… | ||||||
| 40:40:33.0.1.1.3.0.1.4 | 40 | Protection of Environment | I | R | 703 | PART 703—CONFIDENTIALITY CLAIMS | § 703.7 EPA review of confidentiality claims under TSCA section 14(g). | EPA | (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 extensio… | ||||||
| 40:40:33.0.1.1.3.0.1.5 | 40 | Protection of Environment | I | R | 703 | PART 703—CONFIDENTIALITY CLAIMS | § 703.8 EPA review of confidentiality claims under TSCA section 14(f). | EPA | (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) Substan… |
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CREATE TABLE cfr_sections (
section_id TEXT PRIMARY KEY,
title_number INTEGER,
title_name TEXT,
chapter TEXT,
subchapter TEXT,
part_number TEXT,
part_name TEXT,
subpart TEXT,
subpart_name TEXT,
section_number TEXT,
section_heading TEXT,
agency TEXT,
authority TEXT,
source_citation TEXT,
amendment_citations TEXT,
full_text TEXT
);
CREATE INDEX idx_cfr_title ON cfr_sections(title_number);
CREATE INDEX idx_cfr_part ON cfr_sections(part_number);
CREATE INDEX idx_cfr_agency ON cfr_sections(agency);