On June 7, 2023, EPA issued a final rule to update confidential business information (CBI) requirements under Toxic Substances Control Act (TSCA) that increases transparency, modernizes the reporting and review procedures for CBI, and aligns with the 2016 amendments to TSCA. The rule took effect August 7, 2023, and included the following:

• Clarifying changes to ensure the regulations specify precisely where EPA has a statutory obligation to require substantiation and deny claims, which will result in more information being made available.
• Changes to better assure that the scope of a CBI claim is clear and limited to information the submitter views as confidential.
• Amendments to narrow 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, that specifies a process for the submitter to promptly correct those issues early in the CBI review.
• 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.
• 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 ensures 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.
• Requirements for electronic reporting of nearly all CBI claims, with enhancements to reporting tools that will prevent or mitigate common procedural errors.
• A new section of the regulation to centralize and standardize how TSCA CBI claims must be asserted and substantiated.
• A requirement that submitters use an appropriate Organisation for Economic Co-operation and Development harmonized template, when available, when submitting health and safety information