On April 25, 2025, the U.S. Environmental Protection Agency (EPA) released new resources to help companies comply with the requirements for review of new chemicals under the Toxic Substances Control Act (TSCA) Section 5, as described in the December 2024 final rule. The new resource provides clear instructions on how to include required data in the current system used for new chemical submissions, while the agency works to update that system. This addition is intended to enhance the quality of information in the new chemicals notice submission and to improve efficiency and timeliness of the EPA risk assessment and new chemicals review process.
The December 2024 final rule clarifies the level of detail for the data that must be submitted with new chemical notices whenever that information is known to or reasonably ascertainable by the submitter. In addition, the final rule states that enhancements to the Central Data Exchange (CDX) for data submission were not finalized concurrently with the amendments to the rule. Until that time, submitters can provide the information required by the rule using the existing CDX workflow. The new information on EPA’s website describes how submitters can satisfy the amended data requirements pending updates to CDX.
Once the CDX updates are complete, EPA intends to contact the stakeholders prior to rolling out the updates. That will inform users that the data elements are included in CDX as of that time and that the use of this supplemental information will no longer be required.
The new resource provides technical information for each data element category required for submission of new chemical notifications. These details are described in Tables 1-9 as shown below with the relevant links. The information below will be updated as changes to the PMN form in CDX are made.
- Table 1: Category of Use Reporting Requirements – 40 CFR 720.45(f)
- Table 2: Own Site Identity Reporting Requirements – 40 CFR 720.45(g)(1)-(2)
- Table 3: Own Site Worker Exposure Reporting Requirements – 40 CFR 720.45(g)(3)
- Table 4: Own Site Environmental Release Reporting Requirements – 40 CFR 720.45(g)(4)
- Table 5: Other Site Identity and Process Diagram Reporting Requirements – 40 CFR 720.45(h)(1)-(2)
- Table 6: Other Site Worker Exposure Reporting Requirements – 40 CFR 720.45(h)(3)
- Table 7: Other Site Environmental Release Reporting Requirements 40 CFR 720.45(h)(4)
- Table 8: Physical/Chemical Properties and Environmental Fate Characteristics Reporting Requirements – 40 CFR 720.45(j)
- Table 9: Updates to the CDX Workflow
The new resources can be found at: Updates to New Chemicals Regulations under the Toxic Substances Control Act | US EPA
The full docket for the final rule can be found at: Regulations.gov
Published May 20, 2025
This article was generated with the assistance of Artificial Intelligence.