EPA Temporarily Waives Some Requirements under New Confidential Business Information Procedures Rule
Waiver will ensure that new electronic reporting tools are ready for TSCA submitters
Released August 10, 2023
On June 7, the U.S. Environmental Protection Agency (EPA) published the final Confidential Business Information Claims Under the Toxic Substances Control Act (TSCA) rule, which makes a variety of changes to existing EPA regulations regarding assertion and treatment of confidential business information (CBI) under TSCA. Some of the changes require new electronic reporting tools, which are under development. To ensure the smoothest possible reporting experience for TSCA submitters using the new tools, EPA is waiving some of the final rule’s requirements until October 16, 2023 (see 2023 Waiver of CBI Electronic Reporting Requirements (pdf) ).
Specifically, the final rule includes a provision at 40 CFR 703.5(f), requiring that all TSCA submissions bearing CBI claims (with limited exceptions) be submitted via EPA’s electronic submission portal, CDX. Many TSCA submissions are already filed using previously developed CDX submission tools, including some tools required under existing TSCA regulations.
EPA has been developing additional tools necessary to enable the expanded electronic reporting that are required by section 703.5(f) by the new rule, which took effect on August 7, 2023. However, development and testing of these tools will not be complete in time to enable the additional electronic reporting required by section 703.5(f). EPA expects these tools to be available by October 16, 2023.
Section 703.5(f)(1) provides that EPA reserves the ability to waive these electronic reporting requirements, at its discretion, where compliance is infeasible. EPA has made use of this provision to waive the following selected electronic reporting requirements until the new electronic reporting tools are deployed:
- Responses to new substantiation questions (40 CFR 703.5(b)) embedded in the following CISS TSCA reporting tools/forms:
- Enforcement Communication Form
- General Communication Form
- Mercury Electronic Reporting Form
- Risk Evaluation Submission Forms
- Section 12(b) Form
- Section 4 Forms
- Section 5 Notices and Supports Forms
- Section 8(d) – Health & Safety Data Report Form
- Section 8(e) – Notice Form
- New electronic reporting requirements for the following submission types:
- TSCA Section 12(b)
- TSCA Section 8(c)
- TSCA Section 8(e) (if the submission includes CBI claims)
The waiver is effective until October 16, 2023.
In the period between August 7, 2023, and October 16, 2023, TSCA submitters should continue to use the existing reporting tools in CDX to provide any required CBI substantiations. When submitting CBI substantiations, submitters should continue to attach a separate substantiation document with those submissions made using reporting tools that do not incorporate substantiation questions embedded where the information is entered. The substantiation attachment should provide responses to the new substantiation questions (40 CFR 703.5(b)). Substantiation attachment template documents with the updated questions are available on EPA’s website for those who voluntarily choose to use them. (Note that EPA's CBI webpages have also been updated to reflect the requirements of the new rule.) For those opting not to use the EPA provided substantiation attachment templates, responses to the new substantiation questions should be provided in the substantiation attachment included with these submissions.
Electronic reporting tools for TSCA Section 12(b) and TSCA Section 8(e) submissions have been available for use on a voluntary basis for some time. EPA expects that submitters will comply with these requirements by using the existing electronic reporting tools.
The requirement to report health and safety studies using an appropriate Organisation for Economic Co-operation and Development harmonized template (OHT) is not impacted by this waiver. However, because EPA has not yet developed detailed, TSCA-specific instructions for choosing, populating, and submitting OHTs, EPA intends to be flexible in the initial implementation of this new requirement.
Read the waiver: 2023 Waiver of CBI Electronic Reporting Requirements (pdf)