On May 12, 2022, EPA proposed a rule (87 FR 29078) that would update requirements for making confidential business information (CBI) claims under TSCA. According to the proposal, the focus of the rule is to enhance transparency and modernize reporting and review procedures for CBI claims. In addition, the rule will impose some additional requirements for making CBI claims to better comport with the Lautenberg amendments. These new requirements include changes to the following areas detailed below.
Substantiation and Exemptions
Two changes are proposed for the substantiation requirements. First, proposed section 703.5 provides further clarification and reiterates that where a TSCA submission identifies a chemical substance listed on the confidential portion of the TSCA Inventory but does not assert a confidentiality claim, the specific chemical identity would no longer be eligible for confidential treatment on the TSCA Inventory. Second, proposed rule section 703.5(b)(1) would require claimants to assert their CBI claims at the time of submission. It would also require that such claims are accompanied by the requisite substantiation. Here-to-fore, substantiation at the time of submission has been required for some but not all TSCA submissions. The proposed rule, sections 703.5(b)(3) and (4), also specifies the standard set of substantiation questions that will apply to TSCA CBI claims. These questions include:
Proposed Section 703.5(b)(3) Substantiation Questions for all Claims:
- What harm to the competitive position of your business would be likely to result from the release of the information claimed as confidential? How would that harm be substantial? Why is the substantial harm to your competitive position likely (i.e., probable?
- Has your business taken precautions to protect the confidentiality of the disclosed information? If yes, please explain and identify the specific measures.
- Is any of the information claimed as confidential required to be publicly disclosed under any other Federal law? If yes, please explain.
- Does any of the information claimed as confidential otherwise appear in any public documents? If yes, please explain why the information should be treated as confidential.
- Does any of the information claimed as confidential appear in one or more patents or patent applications? If yes, please provide the associated patent number or patent application number (or numbers) and explain why the information should be treated as confidential.
Proposed Section 703.5(b)(4) – Additional Substantiation Questions for Chemical Identity-Related Claims
- Is this chemical substance publicly known to be in U.S. commerce? If yes, please explain why the specific chemical identity should still be afforded confidential status.
- Does this specific chemical substance leave the site of manufacture (including import) in any form, e.g., as a product, effluent, emission? If yes, please explain what measures have been taken to guard against the discovery of its identity.
- Would disclosure of the specific chemical identity release confidential process information? If yes, please explain.
The substantiation requirements will not apply to information exempt under TSCA section 14(c)(2)(G), including specific information describing the processes used to manufacture or process a chemical; and marketing and sales information.
Public Copies of Submissions
EPA proposes changes to section 703.5(c), requiring the submitter to prepare a separate public copy of a submission where the reporting form or application contains CBI. These changes explicitly state that a public copy of a submission that redacts all or substantially all content within the original submission would most likely not meet the requirements of the rule because it is unlikely that all the information in a form or attachment can appropriately claimed as CBI.
Pursuant to proposed section 703.5(f), nearly all TSCA confidentiality claims must be asserted electronically using the reporting tools within the Chemical Information Submission System (CISS).
Generic Name Criteria
The proposed rule addresses generic names for chemicals not on the TSCA inventory. It outlines the criteria for the masking of portions of the chemical name. In addition, the proposed rule would require an accompanying explanation request for extensive masking. The proposed changes would be included in sections 703.5(d)(2)-(4).
Reporting Health and Safety Data Using Harmonized Templates
The proposed rule also addresses confidentiality claims and health and safety studies. Under TSCA section 14(b)(2), confidentiality claims cannot be asserted in health and safety studies. However, TSCA section 14(b)(2) does permit withholding specified information contained in these studies that do not apply to human or environmental health. Previously, the treatment of this information lacked uniformity. Accordingly, proposed section 703.5(g) mandates that health and safety information be reported using harmonized templates. Additionally, under section 703.3 of the proposed rule, EPA has identified the types of information within health and safety studies for which confidentiality claims may be asserted.
Proposed section 703.5(e) addresses deficient claims (e.g., submissions that include a generic name that does not meet the requirements of proposed section 703.5(d) or rely on inappropriate substantiation exemption assertions). When EPA identifies a claim as deficient, the Agency will provide notice of the deficiency to the submitter. Confidentiality claims identified as deficient will be held for ten business days after the claimant has been notified. If the deficiency is not remedied during the suspension, EPA may proceed with reviewing the submission as is and may subsequently deny the claim. Proposed section 703.5(i) refers to the procedures for withdrawing confidentiality claims.
* * *
These proposed changes are intended to narrow the scope of CBI claims. EPA contends that these changes will provide the public with greater access to up-to-date information regarding the status of CBI claims and the data supporting said claims. EPA also anticipates the guidance provided by the new rule will enhance the clarity and uniformity of CBI claim submissions. This is expected to expedite the CBI claim review process and help EPA meet the statutory review deadlines.