EPA Review and Determination of CBI Claims under TSCA
- TSCA CBI Review Requirements
- EPA Considerations for CBI Determinations
- EPA Requirement to Review a Representative Subset of at least 25% of Non-chemical Identity CBI Claims
- Notification Process for CBI Submissions Lacking Required Information
TSCA CBI Review Requirements
Toxic Substances Control Act (TSCA) section 14(g)(1) requires that EPA, within 90 days of receipt of the claim:
- review and make determinations on confidential business information (CBI) claims for chemical identity after the chemical substance has been offered for commercial distribution; and
- review and make determinations on a representative subset of at least 25% of other CBI claims that are not exempt from substantiation and review.
EPA evaluates submissions with CBI claims to ensure that the procedural requirements for making a claim are met. These requirements include:
- the required certification statements;
- information claimed as CBI is clearly identified;
- substantiation of CBI claims for information that is not exempt from substantiation under section 14(c)(2);
- sanitized copy provided where needed; and
- if a CBI claim is for specific chemical identity, a structurally descriptive generic name.
EPA Considerations for CBI Determinations
Once EPA verifies that all the procedural requirements for making a CBI claim have been satisfied, EPA considers each of the following in making a CBI determination:
- A business’s claim and substantiation;
- the provisions of TSCA and applicable regulations;
- any previously-issued determinations which are pertinent;
- and other materials as appropriate.
EPA's determinations identify the specific information in the case for which the CBI determination applies. In some instances, a determination only covers the specific chemical identity of the chemical substance. In other instances, a CBI determination covers all of the other non-exempt information in a case. Finally, in some instances, a CBI determination is made for both the specific chemical identity of the chemical substance and for all of the other non-exempt information in the case.
While EPA will consider prior confidentiality determinations as one factor in making a determination under TSCA, EPA makes a determination on the validity of each CBI claim in the context of the submission in which it is received. For example, if a CBI claim for a company’s name in a Notice of Substantial Risk under TSCA section 8(e) for a chemical not offered for commercial distribution is approved, that does not necessarily mean the same company’s name in a Chemical Data Reporting submission for a chemical that the company is widely known to manufacture would be approved. Similarly, a prior denial of a CBI claim for a company’s name in a submission would not necessarily mean that EPA would not approve a CBI claim for that company’s name in a later submission. A determination of the validity of a CBI claim is made using the information EPA has been provided regarding the claims in the submission under review. For this reason, EPA advises submitters to substantiate CBI claims by looking carefully at the contents of each submission and providing all the information the submitter feels EPA should consider when making a determination.
EPA Requirement to Review a Representative Subset of at least 25% of Non-chemical Identity CBI Claims
In satisfying the obligation to review a representative subset of 25% of non-specific chemical identity CBI claims, EPA reviews every fourth submission received that contains non-specific chemical identity CBI claims. Submissions in which the only CBI claim is for a specific chemical identity will not be reviewed as part of the 25% requirement because specific chemical identity CBI claims are already generally required to be reviewed under TSCA section14(g)(1)(C)(i). Similarly, also not included in the reviews will be submissions with CBI claims for information exempt from substantiation (TSCA section 14(c)(2)). EPA may modify its selection and review procedures in the future, as it gains experience with the new law.
CBI claims can be approved, approved in part and denied in part, or denied by EPA as a result of a review. If a claim is approved in part and denied in part or denied, EPA provides a written statement explaining the reasons for the denial or denial in part according to the provisions of TSCA section 14(g)(2). Submitters whose claims have been asserted according to the requirements in section 14(c) and which have been approved in part and denied in part or denied can appeal the denial in a United States District Court according to the requirements of TSCA section 14(g)(2)(D).
Notification Process for CBI Submissions Lacking Required Information
Beginning on August 15, 2019, EPA will no longer send notices of deficiency to businesses whose submissions do not meet all the statutory requirements. Instead, the Agency will provide written notice to affected business submitters that because they submitted procedurally flawed CBI claims, including unsubstantiated CBI claims, those CBI claims are invalid, and the underlying information is not protected from disclosure under TSCA Section 14. Read the Federal Register notice announcing this change.