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U.S. EPA Amends TSCA CBI Requirements

On June 7, 2023, U.S. EPA published a final rule to amend existing requirements and add new requirements related to confidential business information claims under the Toxic Substances Control Act.

person using a dropper in a laboratory

June 8, 2023

By John Kowalski, senior regulatory specialist, Supply Chain Team, UL Solutions

On June 7, 2023, the U.S. Environmental Protection Agency (EPA) published a final rule to amend existing requirements and add new requirements related to confidential business information (CBI) claims under the Toxic Substances Control Act (TSCA).  Previously, regulatory requirements regarding TSCA CBI claims were spread over multiple parts of the Code of Federal Regulations (CFR).  General provisions regarding CBI claims were codified at 40 CFR Part 2, Subpart B, while TSCA-specific provisions were codified at 40 CFR § 2.306.  In addition, many TSCA regulations contained their own provisions regarding CBI, such as the Chemical Data Reporting regulations at 40 CFR Part  711 and the Premanufacture Notification regulations at 40 CFR Part 720.  In this final rule, most procedural requirements for asserting and maintaining confidentiality claims are organized in a new Part 703 to 40 CFR.  The provisions in 40 CFR Part 703 will apply to any TSCA submission, except as modified by more specific provisions at 40 CFR Part 2 or other TSCA-specific regulations in Title 40 of the CFR.

The 2016 amendments to TSCA included many new provisions regarding the assertion, EPA review, and treatment of CBI claims.  This rule finalizes procedures for asserting CBI claims in TSCA submissions.  It also addresses substantiation requirements, exemptions, electronic reporting enhancements, maintenance or withdrawal of CBI claims, and provisions in current regulations that are inconsistent with amended TSCA.  Finally, the rule addresses EPA procedures for reviewing and communicating with TSCA submitters about CBI claims.

EPA plans to host a public webinar targeted to companies that may include CBI claims in their TSCA submissions.  But, as of this writing, it has not yet announced the date and time of that webinar.

Recommended action items

  • Review the final rule; and
  • Consider attending the webinar.


Confidential Business Information Claims Under the Toxic Substances Control Act (TSCA); Final Rule

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