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:
- 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.
The CBI review requirements of TSCA section 14 apply to submissions to EPA under TSCA, including sections 4, 5, 6, 8, and 12.
Since the enactment of the TSCA amendments in June 2016, EPA has established numerous new processes, systems and procedures to enable submitters to provide the information required when making confidentiality claims and to facilitate EPA's review, and where applicable, determinations on these claims. The statistics provided below show EPA's progress toward meeting the requirements of TSCA section 14.
Please note that EPA adjusted how it reports these case statistics starting with the August 2021 update. From that point forward, most submissions concerning multiple chemicals (e.g., consolidated PMNs or Notices of Activity), though considered one “submission,” are now counted as several individual cases to correspond with the fact that each substance in these submissions is given an individual case number and it is the case that undergoes CBI review. The CBI Review Statistics table now reflects individual cases rather than submissions and is consistent with the downloadable “data on completed TSCA CBI determinations,” also available on this page. This adjustment is intended to provide a more accurate report of the number of CBI case reviews EPA undertakes as well as provide consistency between the summary table and determination documents.
|CBI Review Statistics (cases received between June 22, 2016, and April 1, 2022)|
|Cases in which the specific chemical identity is subject to CBI review||4,294|
|Cases in which information other than the specific chemical identity is subject to CBI review||9,534|
|Cases in which both the specific chemical identity and information other than the specific chemical identity is subject to CBI review||4,365|
|Total cases subject to CBI review||18,193|
|Cases resulting in final CBI determinations|
|Cases with all CBI claims subject to review, approved||4,796|
|Cases with all CBI claims subject to review, denied||1,568|
|Cases with CBI claims subject to review, approved-in-part/denied-in-part||663|
|Total cases resulting in final CBI determinations||7,027|
|Cases reviewed with no final CBI determination necessary|
|Cases with all CBI claims screened and found to be exempt from review||2,450|
|Cases with all CBI claims withdrawn by submitter||517|
|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)||1,942|
|Total cases reviewed/screened with no final CBI determination necessary||4,909|
|Cases currently undergoing CBI review|
|Cases currently undergoing CBI review||6,257|
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.
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
- 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 February 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. The CBI reviews covered by this rule are currently scheduled to occur by February 19, 2024. 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 2022, EPA is prioritizing the review of approximately 1,700 chemical identity claims that have incomplete or missing substantiations in the Notice of Activity Form A (NAA) submissions under the TSCA Inventory Notification (Active-Inactive) Requirements Rule. While EPA did not issue any new final confidentiality determinations for chemical identity in NAA filings in 2021, significant progress was made towards analyzing and prioritizing submissions for efficient review and building review processes and infrastructure to support consistent and efficient review for the remaining review plan period ending on February 19, 2024.
One such process is the ongoing effort to identify and move substances from the confidential portion of the Inventory to the public portion of the Inventory, including substances that are part of the review plan and active Inventory substances for which no CBI claim was asserted in an NAA (see TSCA section 8(b)(4)(B)(iv)).
To this end, the identities of 377 chemicals that were reported as non-CBI in a past CDR submission were disclosed by EPA in 2021. Many of these substances were or are expected to be the subject of one or more confidentiality determinations as part of the review plan, which may be expedited by the fact the substance is on the public portion of the TSCA Inventory.
For more information on CBI reviews and determinations, please contact: