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  2. Confidential Business Information under TSCA

Additional information for Substantiating CBI claims on Submissions filed between June 22, 2016 and March 21, 2017

TSCA submissions containing information claimed as CBI and filed between June 22, 2016 and March 21, 2017, must be supplemented to 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 September 19, 2017, to amend these submissions to provide substantiations to the Agency. If a complete substantiation has already been provided to EPA with the submission or in response to a substantiation request, no additional substantiations need be filed for the same information.

Once September 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will inform the affected business that any CBI claims not substantiated at the end of the 30 days will be considered withdrawn, and the information may be made public with no further notice to the affected business.

The links provided below provide further information and guidance on the requirement to provide substantiation, templates that may be used in providing a substantiation, instructions for submitting a substantiation, and other helpful information.

For information on substantiating CBI claims under TSCA at the time of initial submission, including the January 19, 2017 Federal Register notice.
 
For information on how to submit substantiations of CBI claims.
 
For a video detailing the changes made to CDX application to support TSCA requirements for substantiation of CBI.
 
To access substantiation templates (use of substantiation templates is voluntary). 
 
For information on what information might be exempt from substantiation. 
 
For guidance on completing Chemical Data Reporting Form U and Pre-manufacture Notices, including a list of fields used on the forms corresponding to these submission types that EPA believes are exempt from substantiation.
 
If you need to contact EPA or have a CDX related question.

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 About CBI under TSCA to ask a question, provide feedback, or report a problem.
Last updated on January 30, 2025
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