The EPA published a proposed rule on May 12, 2022, for new and amended requirements to tighten regulations regarding how confidential business information (CBI) claims are submitted, assessed, reviewed, and treated by the Agency 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,” states an EPA press release. “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.”
In the past, the Agency has received many CBI claims that were overly broad, which hampered its ability to properly evaluate potential hazards and risks associated with chemicals.
The proposed rule includes the following.
Provisions to increase transparency
- Changes to better ensure that the existence and scope of a CBI claim are 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 promptly correct those issues early in the CBI review and that the 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 ensure more prompt delivery of required notices to submitters of CBI claims, thereby permitting the EPA to make information for which CBI claims have been withdrawn, denied, or expired available to the public more quickly.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 the EPA has observed to:
- Better ensure 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.
- 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 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.
Public comments will be accepted on the proposed rule until July 11, 2022, under docket # EPA-HQ-OPPT-2021-0419.
The EPA is requesting comments on all aspects of the proposed rule and specific comments regarding:
- “Options for addressing, minimizing, or eliminating conflict between provisions under different statutes regarding confidentiality, disclosure, and treatment of information, including but not limited to alternative statutory interpretations, principles that should govern the resolution of conflicts, and options for resolving specific conflicts.
- Whether the proposed approach appropriately balances transparency under TSCA while also ensuring appropriate protections for information obtained initially under another statute consistent with the assurance of privacy implicitly or explicitly provided by the government when such information is obtained.
- The proposed scope of the rulemaking, particularly that information originally obtained without the use of a TSCA authority is nevertheless obtained under TSCA if the Agency has the authority to collect the information and it was used for a TSCA purpose.
- Whether EPA needs to exercise its TSCA authority or invoke its TSCA authority in the original information collection in order for information to be covered by TSCA section 14.
- The proposed treatment of information that was originally submitted under another statute, as well as the alternatives identified.
- Comments on how studies that were originally submitted under FIFRA should be treated under the TSCA regulations.
- Comments on whether and, if so, how the term ‘TSCA submission’ should be defined in proposed section 703.3.”