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  2. Confidential Business Information under TSCA

Substantiating CBI Claims under TSCA at the Time of Initial Submission

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).

These provisions of TSCA section 14 were effective June 22, 2016, when the Frank R. Lautenberg Chemical Safety for the 21st Century Act was passed and were elaborated in the final CBI procedures rule (40 CFR 703 et seq.). 

On this page:

  • How to submit substantiations of CBI claims
  • (Archive)Webinar: Changes to CDX application to support TSCA requirements for  substantiation of CBI
  • EPA Contacts

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. EPA's electronic tools were further updated to incorporate substantiation and other TSCA CBI procedural requirements to coincide with the final CBI procedures rule (40 CFR 703).

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

View the final CBI rule.

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

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.

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 contact

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

  • Jessica Barkas, (202) 250-8880, barkas.jessica@epa.gov
  • Nick Lillo, 202-564-4741, lillo.nicholas@epa.gov

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

  • CDX Help Desk at 1-888-890-1995
  • Central Data Exchange (CDX) hotline

Confidential Business Information under TSCA

  • Overview
  • Health and Safety Information
  • Frequent Questions
  • Making CBI Claims in TSCA Submissions
  • Substantiating CBI Claims under TSCA at the Time of Initial Submission
  • What to Include in CBI Substantiations
  • EPA Review and Determination of CBI Claims under TSCA
  • Policies for Deficient TSCA CBI Submissions
  • Statistics for the TSCA CBI Review Program
Contact Us About CBI under TSCA
Contact Us to ask a question, provide feedback, or report a problem.
Last updated on August 5, 2024
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