EPA Proposes Rule to Update Confidential Business Information Requirements under TSCA
Released on May 12, 2022
Today, the U.S. Environmental Protection Agency (EPA) issued a proposed rule relating to the assertion and maintenance of confidential business information (CBI) claims under the Toxic Substances Control Act (TSCA). The proposed rule includes new and amended requirements that, if finalized, would increase transparency, modernize reporting and review procedures, and ensure consistency with the 2016 amendments to TSCA. In addition to providing increased clarity for TSCA submitters, the changes in this proposed rule are expected to allow EPA to review and make determinations on CBI claims more efficiently, meeting the statutory review deadline in TSCA and more promptly making required notifications to submitters of claims. The proposed rule includes:
Provisions 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.
- 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.
- 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required notices to submitters of CBI claims, thereby permitting EPA to make information for which CBI claims have been withdrawn, denied, or expired available to the public more quickly.
Provisions to Modernize CBI Procedures and Ensure Consistency with Amended 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 consolidate and standardize how TSCA CBI claims must be asserted and substantiated.
- Requirements that health and safety information be submitted using an appropriate Organisation for Economic Co-operation and Development (OECD) 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.
EPA will accept public comments on the proposed rule for 60 days in docket HQ-OPPT-2021-0419 at www.regulations.gov.