Confidential Business Information Claims under the Toxic Substances Control Act (TSCA) (Non-Substantive Change)

EPA is finalizing new and amended requirements concerning the assertion and maintenance of claims of business confidentiality (also known as Confidential Business Information or CBI) under the Toxic Substances Control Act (TSCA), 15 U.S.C. 2601, et seq. The Frank R. Lautenberg Chemical Safety for the 21st Century Act, Pub. L. 114182 referred to in this Notice as Lautenberg), made significant amendments to TSCA including new provisions governing the assertion of CBI claims and requirements concerning Agency review and treatment of confidentiality claims. This final rule specifies procedures for submitting and supporting CBI claims in TSCA submissions, including substantiation requirements applicable at the time of submission, exemptions from the requirement to substantiate, electronic reporting enhancements (which include new electronic reporting requirements, as well as integration of TSCA requirements to provide certain certification statements, substantiation, and generic names when making confidentiality claims), and maintenance or withdrawal of confidentiality claims. The final rule also specifies Agency procedures for reviewing and communicating with TSCA submitters about confidentiality claims, including requirements for submitters to maintain contact information, procedures EPA will use to provide notices to submitters concerning their claims, and the manner in which EPA will notify submitters concerning the impending expiration of certain claims. The final rule includes new provisions, as well as amending and reorganizing existing provisions concerning assertion of confidentiality claims in order to conform to new requirements in Lautenberg. Most procedural requirements for asserting and maintaining a confidentiality claim are organized into a new part of the CFR, which would apply to any TSCA submission, except as modified by or elaborated on elsewhere in parts 704, 707, 716, 717, 720, 721, 723, 725, 770, or 790. The following submissions under TSCA will now have new or amended procedures for substantiated claims of confidentiality: TSCA Section 8(a); 40 CFR 704 TSCA Section 12(b) Notification of Export; 40 CFR 707.75(d) TSCA Section 8(d) Health and Safety Studies; 40 CFR 716.55(a) and (c) TSCA Section 8(c) Allegations of Adverse Effects; 40 CFR 717.19 TSCA Section 5 Premanufacture Notices (PMNs); 40 CFR 720.85 and 720.90 and 720 Subpart F TSCA Section 5 40 CFR 721 Significant New Use Rules (SNURs) TSCA Section 5 Polymer Exemption; 40 CFR 723.250(f); and Low Volume Exemptions 40 CFR 723.50 TSCA Section 5 microorganisms; 40 CFR 725 Subpart C TSCA Title VI Formaldehyde Emissions Standards for Composite Wood; 40 CFR 770 TSCA Section 4 Test Orders; 40 CFR 790

The latest form for Confidential Business Information Claims under the Toxic Substances Control Act (TSCA) (Non-Substantive Change) expires 2026-08-31 and can be found here.

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