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.
On this page:
- General CBI Information for the 2020 CDR Submission Period
- Upcoming Updates to TSCA Inventory
- EPA Contacts
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)).
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.
The 2016 Frank R. Lautenberg Chemical Safety for the 21st Century Act amendments to TSCA required EPA to designate chemical substances on the TSCA Chemical Substance Inventory as either “active” or “inactive” in U.S. commerce. The amendments also required any manufacturer or processor to submit a notice to maintain an existing CBI claim for a specific chemical identity and substantiate that CBI claim. 15 U.S.C. § 2607(b)(4)(B). The original reporting period under the TSCA Inventory Notification Requirements Rule (Active-Inactive Rule) closed on February 7, 2018, for manufacturers and October 5, 2018, for processors. Entities were also permitted to withdraw notices until October 5, 2018.
In early January 2021, EPA announced that it was reopening the reporting period under the TSCA Active-Inactive Rule to permit companies to submit, amend, or withdraw Notice of Activity forms in order to make corrections on CBI claims and substantiations. This action was not published in the Federal Register and did not undergo a notice and public comment process. A subsequent announcement was made that this planned action was undergoing review in accordance with Biden-Harris Administration’s Executive Orders and other regulatory review directives. The regulatory review of this unpublished action is now complete, and EPA has determined not to proceed with the reopening of the Active-Inactive Rule.
EPA will continue to review confidentiality claims for chemical identities and take action to update confidential Inventory status in accordance with section 8(b) and 14 of TSCA, considering any substantiations and other information provided with TSCA submissions as appropriate.
For more information on CBI issues relating to 2020 CDR submissions, please contact:
- Jessica Barkas, 202-250-8880, email@example.com