By Lynn L. Bergeson and Carla N. Hutton
On May 12, 2022, the U.S. Environmental Protection Agency (EPA) published a proposed rule relating to the assertion and maintenance of confidential business information (CBI) claims under the Toxic Substances Control Act (TSCA). 87 Fed. Reg. 29078. EPA states in its May 12, 2022, press release that the proposed rule includes new and amended requirements that, if made final, 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, EPA expects the changes to allow it 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. Comments are due July 11, 2022.
The proposed rule includes:
Provisions Intended to Increase Transparency
- Changes intended to ensure 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 overly broad CBI claims in public copies of TSCA submissions, especially health and safety related information, that specifies a process for the submitter to correct promptly 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, such as 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 to ensure 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required notices to submitters of CBI claims, thereby permitting EPA to make information for which CBI claims have been withdrawn, denied, or expired available to the public more quickly.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 Intended 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:
- Ensure better procedural requirements for asserting a claim are met (with built-in certification and validation features for substantiation and generic names);
- Articulate better and more narrowly 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 Organization for Economic Cooperation and Development (OECD) Harmonized Template (when available), a format that will allow data to be more readily used and shared within EPA while allowing submitters to indicate CBI claims more clearly for EPA consideration.
EPA seeks public comment on all aspects of the proposed rule and the Economic Analysis prepared in support of it. In addition to specific requests for comment included throughout the proposed rule, EPA invites specific comment on:
- EPA’s interpretation of the coverage of TSCA Section 14(a) (proposed Section 703.1) and how this may impact submitters of information to EPA under other statutes, such as the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). EPA states that it is particularly interested in comments on the treatment of FIFRA studies on inert ingredients under TSCA Section 14(b)(2).
- The applicability of the proposed new or revised requirements to submissions received before the effective date of the subsequent final rule. Specifically, EPA requests comment on whether each proposed new or revised requirement should apply only to submissions received on or after the effective date of the final rule; to all submissions received on or after the effective date of the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Act) amendments; or to all submissions regardless of submission date.
- The proposed substantiation questions (proposed Section 703.5(b)), especially the proposal to omit a trade secrets-specific question; on how the patents question might be modified to elicit more pertinent information; and comment on the alternative substantial competitive harm question.
- The proposed list of information that might be included with health and safety information, but that might be permissible to withhold as confidential (proposed Section 703.5(b)(6)). EPA is also interested in comment on alternatives to the proposal that might better ensure that health and safety information is not inappropriately treated as confidential.
- The proposed approach to CBI claim deficiencies (proposed Section 703.5(e)) and on alternative approaches.
- Whether submitting templated data should be required (proposed Section 703.5(g)).
- The option of requiring TSCA submitters to update their original submission to reflect CBI claims that have been withdrawn or denied (proposed Section 703.5(j)).
- Selection of the representative subset, including possible alternative representative selection methods (proposed Section 703.7).
- Whether bona fide or pre-notice inquiries or correspondence should be considered part of a representative subset of TSCA submissions (proposed Section 703.7).
- On the proposed approach to determining when a TSCA Section 14(g) CBI review period begins and how amendments to the submission are included in the review (proposed Section 703.7).
- The proposed and alternative possible approaches to efficiently developing an acceptable generic name for purposes of listing on the TSCA Inventory, as described in proposed Sections 720.102 and 725.190.
- On how to incorporate whether a substance may be readily reverse engineered into EPA’s substantive review criteria in proposed Section 703.7(f).
Our forthcoming memoranda will include a detailed summary of the proposed rule and an insightful commentary.