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Confidential Business Information under TSCA

CBI Information for the 2020 Chemical Data Reporting Submission Period

This page contains information on making confidential business information (CBI) claims during the 2020 Chemical Data Reporting (CDR) rule submission period.

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General CBI Information for 2020 CDR Submission Period

The 2020 CDR submission period is from June 1, 2020 to January 29, 2021. Amendments to the CDR rule, which became effective on May 11, 2020, included a number of changes to requirements related to claiming CDR data as confidential. These changes were made to align CDR reporting with the Lautenberg Act amendments to TSCA regarding the submission and agency management of CBI claims, including new substantiation requirements, a certification requirement, and a requirement for EPA review of specified CBI claims within 90 days after receipt of the claim. Read more about regulatory changes for the 2020 CDR submission period.

EPA interprets TSCA section 14(c)(3) as requiring substantiation of any non-exempt CBI claim at the time the information claimed as CBI is submitted to EPA. The 2020 CDR rule amendments require substantiation for all confidentiality claims except for those types of information exempt from substantiation under TSCA section 14(c)(2).  A set of standard questions, set forth in 40 CFR 711.30(b), applies to all non-exempt CBI claims. Requirements to substantiate confidentiality claims for certain processing and use information are set forth in 40 CFR 711.30(a)(7).

The 2020 CDR rule amendments also describe the data elements that are exempt from the requirement to provide substantiations at the time the data are submitted. Under the rule, the only data elements collected under CDR that may qualify for the TSCA section 14(c)(2) exemption from upfront substantiation requirements are:

  • production volume (711.30(a)(3)(i)); and
  • supplier information associated with joint submissions, such as supplier identity and details of the full composition of a mixture (711.30(a)(3)(ii) and (iii)).

Learn more about how to report under CDR.

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Upcoming Updates to TSCA Inventory

In May 2020, EPA posted the following preliminary list of 2,812 chemicals by accession number that are expected to lose their CBI status and move to the public portion of the TSCA Inventory.

View the list of chemicals by accession number that EPA expects to disclose on the public TSCA Inventory (xlsx)(50 K)

Since then, EPA has become aware of submitter confusion and issues regarding CBI claims during the initial reporting period of the TSCA Active-Inactive Rule. In January 2021, EPA announced that it was reopening the reporting period under the TSCA Active-Inactive Rule where companies identified chemicals that were manufactured, imported, or processed in the United States during the 10-year time period ending on June 21, 2016. This action enables companies to submit, amend, or withdraw filings under the Active-Inactive Rule in order to maintain existing CBI claims for specific chemical identity.

The Lautenberg Act amendments to TSCA changed CBI reporting requirements and requires EPA to move from the confidential to the public portion of the Inventory any active chemical substance for which no request is received to maintain an existing CBI claim for chemical identity. The change in confidential status for the 2,812 chemicals on the above list is due either to the fact that the claim was not reasserted as required in a Notice of Activity under TSCA section 8(b) or because the claim has been denied (because, for example, the substance was reported as non-confidential in a prior CDR submission or in a Notice of Activity). 

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EPA Contacts

For more information on CBI issues relating to 2020 CDR submissions, please contact:

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