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Review of Confidential Business Information Claims under TSCA

Progress Declassifying Information Classified as Confidential Business Information (CBI)

Periodically EPA reports progress in reviewing more than 24,000 submissions of health and safety studies that have been submitted to EPA that could include CBI claims for the chemical identity.

As part of the same activity, EPA also reports on its efforts to review chemicals designated as CBI in its comprehensive list of chemicals authorized to be in commerce, the TSCA Chemical Substances Inventory. 

Update as of December 2014:

  • EPA has declassified a total of 643 chemical identities. The Agency has moved these chemical identities from the confidential to the public portion of the TSCA Chemical Substances Inventory since 2009.

  • EPA has increased the number of publicly available health and safety studies. EPA is releasing health and safety submissions in which the chemical identity had been confidential but has recently been declassified. Find the declassified documents for these cases by searching the Chemical Data Access Tool (CDAT). Click the “declass” tab and then hit the search button.

  • EPA has completed reviews of just under 24,000 cases. These reviews include both existing and new/prospective cases. Completed reviews include cases in which the chemical identity has been declassified, cases in which the CBI claims were allowed, and cases where there was no CBI health and safety study. The most significant contributing factors to date for declassifications and reviews have been:
    • TSCA CBI Voluntary Declassification Challenge
    • Internal review of data generated from older IT systems and the release of CBI claims for chemical identity by submitters at time of a TSCA section 5 Notice of Commencement of Manufacture.
  • The universe of existing TSCA cases to be reviewed is now down to 565 from 22,483. To address the remaining cases, mostly TSCA section 5 submissions, EPA will be reviewing related filings, contacting the submitter, or their successors, and in other ways initiating reviews in accordance with 40 CFR part 2.