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 to November 30, 2020. 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)).
EPA has reviewed information on 2,814 chemicals on the TSCA Inventory and concluded that the specific chemical identity of these substances can no longer be claimed as CBI under TSCA. As a result, EPA plans to list the names and CAS Register Numbers (if available) of these 2,814 chemicals on the public TSCA Inventory later this year. This action will increase the amount of chemical information stakeholders and the public have access to, upholding our commitment to increasing transparency in the TSCA program while protecting valid CBI claims.
EPA is posting a preliminary list of these chemicals by accession number to assist companies submitting data during the 2020 CDR reporting period as they make decisions on CBI claims. CDR submitters can use this list to quickly identify chemicals that the agency anticipates will no longer be treated as confidential in future updates of the TSCA Inventory.
CDR submitters are encouraged to consult this list prior to filing 2020 CDR submissions and carefully consider confidentiality claims relating to these substances. The agency anticipates denying CBI claims for any chemical on this list made during the 2020 CDR reporting period.
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 2,814 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).
For more information on CBI issues relating to 2020 CDR submissions, please contact:
- Scott Sherlock, 202-564-8257, email@example.com
- Jessica Barkas, 202-250-8880, firstname.lastname@example.org