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Confidential Business Information under TSCA

Substantiating CBI Claims under TSCA at the Time of Initial Submission

For submissions made 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).

The provisions of TSCA section 14 were effective June 22, 2016, when the Frank R. Lautenberg Chemical Safety for the 21st Century Act was passed. EPA announced its interpretation of section 14(c)(3) in a Federal Register Notice on January 19, 2017, which included 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.

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TSCA submissions filed on or after March 21, 2017

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.

TSCA submissions received by EPA prior to August 15, 2019, that lack complete substantiation or that fail to meet any other procedural requirement for asserting a CBI claim are considered deficient. EPA will send a notice of deficiency to the affected business in these cases. The notice informs 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not been received by EPA within 30 days of receipt of the letter, any CBI claims not substantiated will be considered withdrawn, and the information may be made public with no further notice to the affected business.

On August 15, 2019, EPA stopped sending out notices of deficiency to businesses who fail to substantiate non-exempt CBI claims or otherwise submit CBI claims without complying with TSCA statutory requirements at the time the information is submitted to EPA. Instead, the Agency will provide written notice to affected business submitters who submit procedurally flawed CBI claims, including unsubstantiated CBI claims, that those CBI claims are invalid and not entitled to protection under TSCA Section 14. Read the Federal Register notice announcing this change.

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How to submit substantiations of CBI claims

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.

Find more information on electronic reporting, including how to make amendments.

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

Courier Deliveries:
U.S. EPA
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
(202) 564-8930

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Webinar: changes to CDX application to support TSCA requirements for substantiation of CBI

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:

  1. 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.

  2. 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.

  3. 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.

EPA contacts

For more information regarding substantiation of CBI claims at the time of initial submission, please contact:

For help with issues relating to electronic reporting, please contact:

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