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August 14, 2023

EPA Temporarily Waives Some Requirements under New CBI Procedures Rule

Lynn L. Bergeson Carla N. Hutton

As reported in our June 12, 2023, memorandum, the U.S. Environmental Protection Agency (EPA) published on June 7, 2023, a final rule with new and amended requirements concerning the assertion and treatment of confidential business information (CBI) claims for information reported to or otherwise obtained by EPA under the Toxic Substances Control Act (TSCA). EPA announced on August 10, 2023, that to ensure the “smoothest possible reporting experience” for TSCA submitters using the new tools, EPA is waiving some of the final rule’s requirements until October 16, 2023. The final rule includes a provision at 40 C.F.R. Section 703.5(f) requiring that all TSCA submissions bearing CBI claims (with limited exceptions) be submitted via EPA’s electronic submission portal, Central Data Exchange (CDX). EPA states that it has been developing additional tools necessary to enable the expanded electronic reporting that are required by Section 703.5(f) by the new rule, which took effect on August 7, 2023. EPA notes that development and testing of these tools will not be complete in time to enable the additional electronic reporting required by Section 703.5(f), however. EPA expects these tools to be available by October 16, 2023.
EPA states that Section 703.5(f)(1) allows it to waive these electronic reporting requirements, at its discretion, where compliance is infeasible. EPA has made use of this provision to waive the following selected electronic reporting requirements until the new electronic reporting tools are deployed:

  • Responses to new substantiation questions (40 C.F.R. Section 703.5(b)) embedded in the following Chemical Information Submission System (CISS) TSCA reporting tools/forms:
    • Enforcement Communication Form;
    • General Communication Form;
    • Mercury Electronic Reporting Form;
    • Risk Evaluation Submission Forms;
    • Section 12(b) Form;
    • Section 4 Forms;
    • Section 5 Notices and Supports Forms;
    • Section 8(d) — Health & Safety Data Report Form; and
    • Section 8(e) — Notice Form.
  • New electronic reporting requirements for the following submission types:
    • TSCA Section 12(b);
    • TSCA Section 8(c); and
    • TSCA Section 8(e) (if the submission includes CBI claims).

EPA states that in the period between August 7, 2023, and October 16, 2023, TSCA submitters should continue to use the existing reporting tools in CDX to provide any required CBI substantiations. According to EPA, when submitting CBI substantiations, submitters should continue to attach a separate substantiation document with those submissions made using reporting tools that do not incorporate substantiation questions embedded where the information is entered.
EPA notes that electronic reporting tools for TSCA Section 12(b) and TSCA Section 8(e) submissions have been available for use on a voluntary basis for some time. EPA “expects that submitters will comply with these requirements by using the existing electronic reporting tools.”
EPA states that the requirement to report health and safety studies using an appropriate Organization for Economic Cooperation and Development (OECD) harmonized template (OHT) is not impacted by this waiver. Because EPA has not yet developed detailed, TSCA-specific instructions for choosing, populating, and submitting OHTs, however, “EPA intends to be flexible in the initial implementation of this new requirement.”