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. A “case” is a submission made under a specific section of TSCA and all subsequent submissions and amendments by the same submitter that relate back to the first submission.
|CBI Review Statistics (cases received between June 22, 2016 and December 28, 2020)|
|Cases in which the specific chemical identity is subject to CBI review||3,444|
|Cases in which information other than the specific chemical identity is subject to CBI review||2,926|
|Cases in which both the specific chemical identity and information other than the specific chemical identity is subject to CBI review||870|
|Total cases subject to CBI review||7,240|
|Cases resulting in final CBI determinations|
|Cases with all CBI claims subject to review, approved||1,283|
|Cases with all CBI claims subject to review, denied||731|
|Cases with CBI claims subject to review, approved-in-part/denied-in-part||221|
|Total cases resulting in final CBI determinations||2,235|
|Cases reviewed with no final CBI determination necessary|
|Cases with all CBI claims screened and found to be exempt from review||1,341|
|Cases with all CBI claims withdrawn by submitter||380|
|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)||1,707|
|Total cases reviewed/screened with no final CBI determination necessary||3,428|
|Cases currently undergoing CBI review|
|Cases currently undergoing CBI review||1,577|
In January 2021, EPA published 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.
Download data on completed TSCA CBI determinations (XLSX) (xlsx) . 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. 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.
After consideration of the number of claims needing review and EPA’s available resources, EPA has determined that its goal for calendar year 2021 is to prioritize the review of confidential chemical identities reported in the Active Inactive Rule that were also reported in the 2020 Chemical Data Reporting (CDR) rule reports. EPA will also prioritize refining document handling and review infrastructure to facilitate the efficient reviews of the remaining CBI claims for chemical identity which will be completed by February 19, 2024.
EPA publishes the results of TSCA CBI determinations for all TSCA submissions a few times each year. EPA issued 540 final confidentiality determinations for chemical identity in Notice of Activity Form A (NAA) filings concerning 383 active substances on the confidential portion of the TSCA Inventory in 2020.
For more information on CBI reviews and determinations, please contact: