What to Include in CBI Substantiations

In order for EPA to make a determination regarding the validity of a confidential business information (CBI) claim in a particular Toxic Substances Control Act (TSCA) submission, information regarding the basis for the CBI claim (i.e., substantiation) must be provided. Submitters may provide to EPA any information they believe supports the validity of their CBI claims but at a minimum must answer the substantiation questions required in 40 CFR 703.5(b) (except as modified in the individual reporting rules—e.g., the CDR rule in 40 CFR 711).

When reviewing and making a CBI determination, EPA considers each CBI claim and corresponding substantiation, the provisions of TSCA and applicable regulations, any previously-issued determinations which are pertinent, and other relevant materials as appropriate.  Learn more about EPA’s review and determination of CBI claims under TSCA, including prior confidentiality determinations. See also 40 CFR 703.7(f).

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Sample substantiation templates

In order to assist submitters in substantiating their CBI claims, EPA developed substantiation templates that could be used as a starting point in preparing their CBI substantiations for uploading into CDX electronic reporting applications or for inclusion with paper submissions. The templates have largely been superseded by the requirements of the CBI procedures rule and corresponding development or updates to most TSCA electronic reporting applications which now incorporate substantiation requirements.  However, TSCA submitters may find the templates useful as guidance when preparing a TSCA submission that includes CBI claims or when providing substantiation for an older TSCA submission that has become the subject of CBI review (e.g., as related to a FOIA request).

Information exempt from substantiation

TSCA section 14(c)(2) identifies certain information that is generally not subject to substantiation requirements. This information includes:

  1. Specific information describing the processes used in manufacture or processing of a chemical substance, mixture, or article;
  2. Marketing and sales information;
  3. Information identifying a supplier or customer;
  4. In the case of a mixture, details of the full composition of the mixture and the respective percentages of constituents;
  5. Specific information regarding the use, function, or application of a chemical substance or mixture in a process, mixture, or article;
  6. Specific production or import volumes of the manufacturer or processor; and
  7. Prior to the date on which a chemical substance is first offered for commercial distribution, the specific chemical identity of the chemical substance, including the chemical name, molecular formula, Chemical Abstracts Service number, and other information that would identify the specific chemical substance, if the specific chemical identity was claimed as confidential at the time it was submitted in a notice under TSCA  5.

In addition, individual TSCA reporting applications and specific reporting rules generally indicate which data elements are exempt or may be exempt from upfront substantiation requirements.

EPA Contact

For more information on what information to include in CBI substantiations, please contact:

Confidential Business Information under TSCA

Contact Us About CBI under TSCA
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Last updated on August 5, 2024