WASHINGTON (June 1, 2023) — Today, the U.S. Environmental Protection Agency (EPA) issued a final rule to update confidential business information (CBI) requirements under the 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 final rule allows EPA to release non-confidential information more quickly, demonstrating EPA’s ongoing commitment to transparency and data integrity, and makes the process for submitting and substantiating CBI claims more efficient.

“Today’s rule is an important step forward as we work to improve transparency in our chemical safety program,” said Assistant Administrator for the Office of Chemical Safety and Pollution Prevention Michal Freedhoff. “Putting a process in place to make more health and safety data publicly available more quickly helps give communities have the information they need to make informed decisions about the chemicals they’re exposed to.”

The rule includes 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. The final rule also includes the following.

Measures to Increase Transparency

• Changes to better assure that the existence and 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. For example, the name of the laboratory conducting the study cannot be claimed as CBI unless the name of the laboratory would reveal an association with a company whose connection to a chemical is considered CBI.
• A provision to address inappropriate or over-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 and that EPA would promptly deny any remaining inappropriate claims. These changes are expected to remove ambiguity about the scope or validity of claims, permitting more rapid review of valid CBI claims and public access to non-CBI information. The final rule does not include EPA’s proposal to create a new “re-consideration process” in regulation for denied claims, which could have had the unintended result of more requests for reconsideration and associated delays in public access. Rather, EPA will rely on its existing process.
• Expanded requirements for electronic reporting and uniform requirements to provide publicly releasable copies of certain documents like scientific studies, both of which would make more data available to the public more quickly.
• Requirements for electronic communication and maintaining current and accurate contact information will assure more prompt delivery of required notices to submitters of CBI claims, thereby permitting EPA to make information for which CBI claims have been withdrawn, denied, or expired available to the public more quickly.
• The final rule also clarifies language included in the proposed rule on how EPA will handle information used in the TSCA program but obtained under other statutes that also has valid CBI claims under those other statutes, in order to ensure consistency with the agency’s duty to make information publicly available when it’s legally able to do so. For example, data used under TSCA might have originally been submitted under and protected from disclosure under another statute, such as the Federal Insecticide, Rodenticide and Fungicide Act (FIFRA), which prohibits disclosure of certain pesticide data to persons who are acting on behalf of a multinational competitor of the data submitter. The final rule would preserve the protections from disclosure that are required under FIFRA for international trade purposes, while maximizing the disclosure of information that cannot be claimed as confidential business information under TSCA. 

Measures to Modernize CBI Procedures and Ensure Consistency with Updated TSCA

• Clear and uniform guidance on requirements for assertion and maintenance of CBI claims, including a standard set of substantiation questions used to support a CBI claim.
• Requirements for electronic reporting of virtually all CBI claims, with enhancements to reporting tools that will prevent or mitigate common procedural errors EPA has observed to:
  • better assure procedural requirements for asserting a claim are met (with built-in certification and validation features for substantiation and generic names);
  • better and more narrowly articulate the confidential information that is being claimed; and
  • clarify CBI provisions that apply to individual data elements, such as where CBI claims are not permitted or where upfront CBI substantiation is not required to support a claim.
• Establishment of a new section of the TSCA regulations to centralize and standardize how TSCA CBI claims must be asserted and substantiated.
• Requirements that when health and safety information is submitted, submitters also use an appropriate Organisation for Economic Co-operation and Development harmonized template (when available), a format that will allow data to be more readily used and shared within the Agency while allowing submitters to indicate CBI claims more clearly for EPA consideration.

In the coming weeks, EPA will host a public webinar targeted to companies that may include CBI claims in their TSCA submissions, but useful for anyone looking for an overview of the final rule. The date, time and registration information will be announced soon.

The rule takes effect 60 days after publication in the Federal Register.

Learn more and read a prepublication version of the final rule. 

Contact: EPA Press Office (press@epa.gov)