Substantiating CBI Claims under TSCA at the Time of Initial Submission
Beginning on or after March 21, 2017, all confidential business information (CBI) claims must be substantiated at the time the information claimed as CBI is submitted to EPA, except for those types of information exempt under Toxic Substances Control Act (TSCA) section 14(c)(2).
- Read the Federal Register Notice announcing EPA’s interpretation of revised TSCA requiring up front substantiation of CBI claims.
- Effective date for Federal Register Notice on substantiating TSCA CBI claims delayed to March 21, 2016.
The provisions of TSCA section 14 were effective as of the passing of the Frank R. Lautenberg Chemical Safety for the 21st Century Act on June 22, 2016. However, because EPA announced its interpretation of section 14(c)(3) in a Federal Register Notice on January 19, 2017, there are separate sets of procedures for substantiating claims for information submitted before the effective date of the Federal Register Notice, March 21, 2017, and claims for information submitted after the effective date.
On this page:
- TSCA submissions filed on or after March 21, 2017
- TSCA submissions filed between June 22, 2016 and March 21, 2017
- How to submit substantiations of CBI claims
- Webinar: Changes to CDX application to support TSCA requirements for substantiation of CBI
- EPA Contacts
Those submissions containing information claimed as CBI filed on or after March 21, 2017, must provide a substantiation for all information claimed as confidential, other than information exempt from substantiation pursuant to TSCA section 14 (c)(2), at the time of submission.
Any non-exempt CBI claim that is submitted without a substantiation will be considered deficient, and EPA will send a notice of deficiency to the affected business. The notice will inform the affected business that:
- it must submit its substantiation within 30 calendar days in order to remedy its deficient CBI claim; and
- if a timely substantiation has not been received by EPA within 30 days of receipt of the letter, any CBI claims not substantiated will be considered withdrawn, and the information may be made public with no further notice to the affected business.
Those submissions containing information claimed as CBI filed between June 22, 2016 and March 21, 2017, must provide a substantiation for all information claimed as confidential, other than information exempt from substantiation requirements pursuant to TSCA Section 14(c)(2). EPA is giving submitters until October 19, 2017, to provide substantiations to the Agency. If a substantiation has already been provided to EPA with the submission or in response to a substantiation request, no additional substantiation need be filed for the same information.
Be aware, however, that if some non-exempt information claimed as confidential in a particular submission has already been substantiated and some has not, the unsubstantiated information claimed as CBI in the submission must still be substantiated by October 19, 2017.
The CBI claims, and the substantiations, may then be reviewed consistent with the provisions of TSCA, its implementing regulations and in accordance with the Agency procedures set forth in 40 CFR part 2, subpart B. Once October 19, 2017, has passed, if no substantiation has been received for a claim, then EPA will provide the affected business 30 days’ notice and a final opportunity to substantiate. The notice will inform the affected business that any CBI claims not substantiated at the end of the 30 days will be considered withdrawn, and the information may be made public with no further notice to the affected business.
EPA’s electronic reporting systems for TSCA submissions have been modified to accept substantiations for CBI claims in submissions filed on or after March 21, 2017. In addition, any new paper TSCA submissions that are directed to the Agency after that date must include substantiations for all non-exempt CBI claims at the time of submission.
For information submitted using EPA’s Central Data Exchange (CDX) during the period from June 22, 2016, to March 21, 2017, that is not exempt from substantiation and was not substantiated, affected businesses must provide substantiation for CBI claims using the amendment processes for the particular submission type.
For any paper TSCA submissions that were submitted to the Agency during the period from June 22, 2016, to March 21, 2017, the affected business must submit substantiations for any non-exempt CBI claims that have not yet been substantiated. Submit these substantiations to:
TSCA Confidential Business Information Center (7407M)
WJC East; Room 6428; Attn: TSCA CBI Substantiations.
U.S. Environmental Protection Agency
1200 Pennsylvania Avenue, NW
Washington, DC 20460-0001
Office of Pollution Prevention and Toxics
Confidential Business Information Center (CBIC)
Attn: TSCA CBI Substantiations
1201 Constitution Avenue, NW
WJC East; Room 6428
Washington, DC 20004-3302
In March 2017, EPA conducted two webinars covering the use of CDX for upfront CBI substantiation. These webinars covered technical aspects of making substantiations within the CDX reporting applications at the time information is first claimed as CBI. View the webinar below, and the related substantiation templates discussed in the webinar. If you have trouble viewing the webinar below you can watch the webinar on YouTube.Exit
This webinar recording has three general sections:
An introduction explaining the new substantiation requirements and the effective dates for these requirements. This section can be found at the start of the recording through the 6 minute 50 second mark.
A demonstration of the TSCA CDX application changes and how to submit upfront substantiation using the optional substantiation templates. This section starts at the 6 minute 50 second mark and extends through the 21 minute 40 second mark.
A question and answer session, where technical questions related to the process of submitting upfront substantiation were addressed. This section starts at the 21 minute 40 second mark and extends through the end of the recording.
For more information regarding substantiation of CBI claims at the time of initial submission, please contact:
- Scott Sherlock, 202-564-8257, email@example.com
- Jessica Barkas, 202-250-8880, firstname.lastname@example.org
For help with issues relating to electronic reporting, please contact:
- CDX Help Desk at 1-888-890-1995
- Central Data Exchange (CDX) hotline