Statistics for the TSCA CBI Review Program

Under the Toxic Substances Control Act (TSCA), EPA must review and make determinations for certain confidential business information (CBI) claims. Specifically, TSCA section 14(g)(1) requires that EPA, within 90 days of receipt of the claim:

• TSCA CBI Review Statistics
• CBI Review and Final Determinations
• Annual CBI Goal
• EPA Contacts

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TSCA CBI Review Statistics

As a result of the June 2016 amendments to TSCA, EPA established new procedures to enable submitters to provide information required to establish confidentiality claims and facilitate EPA's review and determinations on these claims as appropriate. The statistics provided below show EPA's progress toward meeting the requirements of TSCA section 14.

In August 2021, EPA adjusted how it reports case statistics. From that point forward, most submissions concerning multiple chemicals (e.g., consolidated premanufacture notices or notices of activity), though considered one submission, are now counted as several individual cases. EPA made this change because each substance in such submissions is assigned an individual case number, and each case undergoes CBI review.

As EPA strives to continually improve the TSCA CBI review program, including the IT systems that track and facilitate completion of TSCA CBI reviews, corrections to previously reported figures may be necessary.

CBI Review Statistics (cases received between June 22, 2016, and April 1, 2024)
Cases in which the specific chemical identity is subject to CBI review	9,105
Cases in which information other than the specific chemical identity is subject to CBI review	10,064
Cases in which both the specific chemical identity and information other than the specific chemical identity is subject to CBI review	2,375
Total cases subject to CBI review	21,544

Cases resulting in final CBI determinations
Cases with all CBI claims subject to review, approved	6,243
Cases with all CBI claims subject to review, denied	2,687
Cases with CBI claims subject to review, approved-in-part/denied-in-part	988
Total cases resulting in final CBI determinations	9,918

Cases reviewed with no final CBI determination necessary
Cases with all CBI claims screened and found to be exempt from review	2,973
Cases with all CBI claims withdrawn by submitter	568
Cases identified for CBI review, for which no determination required (e.g., in some instances, older EPA information systems do not specifically identify which information is claimed as CBI and upon review, it is determined that no claims require review)	2,148
Total cases reviewed/screened with no final CBI determination necessary	5,689

Cases currently undergoing CBI review
Cases currently undergoing CBI review	5,086

CBI Review and Final Determinations

EPA periodically publishes an updated list of cases with completed CBI reviews under TSCA section 14. This publication keeps the commitment made by EPA to periodically publish information on CBI determinations. These actions continue the agency’s commitment to transparency as we fulfill our responsibilities under the Lautenberg amendments to TSCA.

Downloaded data on completed TSCA CBI determinations   (xlsx) (449.57 KB)

This spreadsheet includes the results of completed CBI determinations and cases with approved claims for specific chemical identity for which unique identifiers have been assigned, including:

Final CBI Determinations:

• Case Number
• Submission Type
• Determination Type (specific chemical identity, other information, or both)
• Final Determination
• Summary Determination Rationale
• Non-Chemical Identity CBI Claim Expiration Date

Unique Identifiers by Case Number:

• Case Number
• EPA Unique Identifier (UID)
• Accession Number
• P-Number
• Generic Name
• Chemical Identity CBI Claim Expiration Date 

Annual CBI Goal

TSCA Section 8(b)(4)(C) required that EPA promulgate a rule establishing a review plan for all active substances whose specific chemical identities are protected from disclosure by inclusion on the confidential portion of the TSCA Inventory. 

On Feb. 19, 2020, EPA finalized a rule on the procedures for companies to substantiate their CBI claims for the specific chemical identities of substances on “active” portion of the TSCA inventory, as well as the review plan for how the Agency will review the claims, the timeframes for EPA to complete reviews, and the annual posting of results. As permitted by TSCA, EPA extended the deadline for CBI reviews covered by this rule from Feb. 19, 2024, to Feb. 19, 2025. TSCA section 8(b)(4)(E)(ii)(II) and 40 CFR 710.55(d) provide that EPA will publish an annual goal for reviews and the number of reviews completed in the prior year at the beginning of each calendar year. 

For calendar year 2023, EPA completed the review of confidentiality claims for specific chemical identity for 1,395 chemicals submitted in Notice of Activity Form A (NAA) submissions under the TSCA Inventory Notification (Active-Inactive) Requirements Rule. 

For calendar year 2024, EPA is continuing the review of chemical identity claims, evaluating provided substantiations and other criteria to determine whether claims meet the requirements to be treated as confidential under TSCA section 14 and the Active-Inactive Requirements Rule.  EPA continues to make progress to complete the review of remaining chemical identity claims consistent with the current February 2025 deadline and will evaluate whether further extension of the deadline is required under TSCA section 8(b)(4)(E)(ii).  

As receipt of CBI determinations is verified and the applicable period for appeal under TSCA Section 14(g)(2)(D) has passed, any specific chemical identities for which the confidentiality claim was denied will be moved to the public portion of the TSCA Inventory which is published approximately every six months. For chemicals for which the confidentiality claim for specific chemical identity are approved, unique identifiers will be assigned according to TSCA Section 14(g)(4).

EPA Contacts

For more information on CBI reviews and determinations, please contact:

• Jessica Barkas, 202-250-8880, [email protected]
• Nick Lillo, 202-564-4741, [email protected]