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Confidential Business Information under TSCA

EPA Review and Determination of CBI Claims under TSCA

Toxic Substances Control Act (TSCA) section 14(g)(1) requires that EPA:

  • review and make determinations on most confidential business information (CBI) claims for chemical identity within 90 days of receipt of the claim; 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 within 90 days of the receipt of the claim.

EPA evaluates all submissions with CBI claims to ensure that all 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.

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.

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.

In satisfying the obligation to review a representative subset of 25% of non-chemical identity CBI claims, EPA reviews every fourth submission received that contains non-chemical identity CBI claims.  Submissions in which the only CBI claim is for chemical identity will not be reviewed as part of the 25% requirement because 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 only CBI claims for the data elements identified in section 14(c)(2). EPA may modify its selection and review procedures in the future, as it gains experience with the new law.

EPA’s review and determination of a CBI claim result in the claim being approved, approved in part and denied in part, or denied. If a claim is denied or approved in part and denied in part, 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 denied or approved in part and denied in part can appeal the denial in a United States District Court according to the requirements of TSCA section 14(g)(2)(D).

When EPA approves a confidential business information (CBI) claim for chemical identity, the Agency is required to:

  • assign a unique identifier to that chemical identity;
  • apply this unique identifier to other information or submissions concerning the same substance; and
  • ensure that any non-confidential information received by the Agency identifies the chemical substance using the unique identifier while the specific chemical identity of the chemical substance is protected from disclosure.

Read the May 2017 Federal Register notice explaining this requirement and requesting comment on three potential approaches for assigning and applying unique identifiers.

Read the February 2018 Federal Register notice requesting comment on an additional potential approach to assigning and applying unique identifiers.

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