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(g). 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 June 25, 2019)|
|Cases in which the specific chemical identity is subject to CBI review||2,177|
|Cases in which information other than the specific chemical identity is subject to CBI review||2,305|
|Cases in which both the specific chemical identity and information other than the specific chemical identity is subject to CBI review||587|
|Total cases subject to CBI review||5,069|
|Cases resulting in final CBI determinations|
|Cases with all CBI claims subject to review, approved||523|
|Cases with all CBI claims subject to review, denied||5|
|Cases with CBI claims subject to review, approved-in-part/denied-in-part||34|
|Cases with all CBI claims subject to review, denial - appeal period pending*||10|
|Total cases resulting in final CBI determinations||572|
* "Denial - appeal period pending" cases are those for which a CBI determination denying one or more CBI claims in a case has been issued to the submitter of the information, but for which the required 30-day notification period following receipt of the determination under TSCA section 14(g)(2)(B) has not yet passed.
|Cases reviewed with no final CBI determination necessary|
|Cases with all CBI claims screened and found to be exempt from review||1,068|
|Cases with all CBI claims withdrawn by submitter||415|
|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)||1,012|
|Total cases reviewed/screened with no final CBI determination necessary||2,495|
|Cases currently undergoing CBI review|
|Cases currently undergoing CBI review||2,002|
Later this year, EPA plans to publish a comprehensive list of cases subject to CBI review to be updated quarterly. The table will include information showing the results of individual cases with completed reviews.
For more information on CBI reviews and determinations, please contact:
- Scott Sherlock, 202-564-8257, firstname.lastname@example.org
- Jessica Barkas, 202-250-8880, email@example.com