Final rule: Requirements for Confidential Business Information (CBI) claims under the Toxic Substances Control Act (TSCA)
The US Environmental Protection Agency (EPA) published a final rule on June 7, 2023, to update confidential business information (CBI) requirements under the Toxic Substances Control Act (TSCA) to increase transparency, modernize the reporting and review procedures for CBI, and align with the 2016 amendments to TSCA. The final rule became effective August 7, 2023.
The final rule clarifies changes to ensure the regulations specify precisely where EPA has a statutory obligation to require substantiation and deny claim and also includes the following:
- Changes to better assure that the scope of a CBI claim is clear and limited to information the submitter views as confidential. The final rule also narrows the types of information in health and safety studies that can be claimed as CBI
- A provision to address overly broad CBI claims in public copies of TSCA submissions, especially health and safety-related information, specifies a process for the submitter to promptly correct those issues early in the CBI review. These changes are expected to remove ambiguity about the scope or validity of the claims
- Expanded requirements for electronic reporting and uniform requirements to provide publicly releasable copies of certain documents like scientific studies, which would make more data available to the public more quickly
- Requirements for electronic communication and maintaining accurate contact information to ensure that required notices of CBI claims are delivered more quickly to the submitters
- Requirements for electronic reporting of nearly all CBI claims, with enhancements to reporting tools that will prevent or mitigate common procedural errors. EPA states that that this requirement most notably affects reporting under TSCA Section 8(e), export notifications under TSCA Section 12(b), and polymer exemption notices under TSCA Section 5, “for which electronic reporting is required for the first time in today’s final rule”
- Clarifying language on how EPA will handle information used in the TSCA program but obtained under other statutes that also have valid CBI claims under those statutes. This will ensure consistency with the Agency’s duty to make information publicly available when it’s legally able to do so
- Clear, uniform guidance on requirements for asserting and maintaining CBI claims, including a standard set of substantiation questions used to support a CBI claim
- A new section of the TSCA regulation to centralize and standardize how TSCA CBI claims must be asserted and substantiated
- A requirement that submitters use an appropriate Organization for Economic Co-operation and Development harmonized template (OHT) when available when submitting health and safety information. This requirement would be in addition to existing requirements to provide a full study report. EPA intends to elaborate on instructions for including OHT files (e.g., currently acceptable file types and IUCLID software versions) as appropriate in individual reporting rules or orders, and/or in the applicable reporting tool instruction documents
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.
Section 703.5(f)(1) provides that EPA reserves the ability 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 CFR 703.5(b)) embedded in the following 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
- Section 8(e) – Notice Form
- TSCA Section 12(b)
- TSCA Section 8(c)
- TSCA Section 8(e) (if the submission includes CBI claims)
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. 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.
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.
The requirement to report health and safety studies using an appropriate Organisation for Economic Co-operation and Development harmonized template (OHT) is not impacted by this waiver. However, because EPA has not yet developed detailed, TSCA-specific instructions for choosing, populating, and submitting OHTs, EPA intends to be flexible in the initial implementation of this new requirement.
How can TSG Consulting help?
TSG Consulting can help with all aspects of chemical compliance under TSCA including:
- Assisting with Confidential Business Information (CBI) substantiation
- Preparing Section 5 Pre-Manufacturing Notices (PMN, LVE, MCAN, TERA)
- Making polymer exemption determinations
- TSCA Section 8(e) reporting
- Chemical import/export matters
If you have any questions, please do not hesitate to reach out to TSG at [email protected].