• EPA evaluates submissions with CBI claims to ensure that the procedural requirements for making a claim are met.
• EPA makes a determination on the validity of each CBI claim in the context of the submission in which it is received.

Toxic Substances Control Act (TSCA) section 14(g)(1) requires that the Environmental Protection Agency (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 percent 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 as required; and
• A structurally descriptive generic name, if a CBI claim is for specific chemical identity.

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’ claim and substantiation;
• The provisions of TSCA and applicable regulations;
• Any previously issued determinations which are pertinent; and
• Other materials as appropriate.

See also 40 CFR 703.7(f), the substantive criteria for use in confidentiality determinations.

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 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.

CBI claims can be approved, approved in part, denied in part, or denied by EPA as a result of a review. If a claim is 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 U.S. District Court according to the requirements of TSCA section 14(g)(2)(D).