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  2. Reviewing New Chemicals under the Toxic Substances Control Act (TSCA)

Integrated Approach for Mixed Metal Oxides New Chemicals Review

Under the Toxic Substances Control Act (TSCA), EPA is implementing a more efficient process to assess risk and apply mitigation measures, as appropriate, for mixed metal oxides (MMOs) used in new and modified cathode active materials (CAMs). 

MMOs have many electrical applications in batteries and uses as catalysts, adsorbents, and in ceramics. Notably, MMOs, including CAMs, are a key component in lithium-ion batteries used in electric vehicles, which are a growing and important industry.  

Like all chemical substances not listed on the TSCA Inventory, MMOs, including new and modified CAMs, are subject to section 5 of TSCA, which requires manufacturers (including importers) of new chemical substances to provide EPA with notice before initiating the activity by submitting a Premanufacture Notice (PMN). When EPA receives a PMN, TSCA requires the agency to fully assess all the potential hazards and exposures of the new chemical substance, make a determination as to whether it presents an unreasonable risk to human health or the environment, and take steps to address that risk before it can enter commerce. 

In addition to launching this integrated approach, EPA is also releasing a Compliance Advisory (pdf) that reaffirms that new MMOs used as CAMs and modified CAMs are new chemical substances subject to TSCA. Anyone who plans to manufacture (including import) a CAM or modified CAM that is not on the TSCA Inventory must comply with the TSCA section 5 new chemical requirements and implementing regulations.

On this page:

  • Outreach and Training
  • Additional Information

Outreach and Training

EPA is conducting outreach and training for interested stakeholders to describe the new standardized approach to reviewing MMOs, basics of TSCA statutory and regulatory requirements, and steps for navigating the new chemicals submission process.  

EPA hosted a webinar on November 17, 2022, to provide an overview of the new approach and answer questions from stakeholders. View the meeting materials (pdf) (629.28 KB) . 

EPA hosted a second and final webinar on March 30, 2023, which went into greater detail on the standardized risk assessment approach and included various case scenarios and a decision tree for identifying potential hazards and risks.  View the meeting materials. (pdf) (713.25 KB)

For information on future outreach efforts, including webinars, subscribe to OCSPP’s news releases. Additionally, this webpage will be updated with more details about upcoming outreach and training sessions.

Additional Information

Read about EPA’s Tools, Models, and Databases.

Read EPA’s October 2021 Climate Adaption Action Plan.

Read Compliance Advisory: Applicability of the Toxic Substances Control Act to Mixed Metal Oxides, which Include Cathode Active Materials (CAMs) and Modified CAMs (pdf) (180.23 KB, 10/5/2022)

Read the press release.

Reviewing New Chemicals under the Toxic Substances Control Act (TSCA)

  • Basic Information
  • EPA's Review Process
  • Filing a Premanufacture Notice with EPA
  • Regulatory Actions Under TSCA section 5
  • Premanufacture Notice Status
Reviewing New Chemicals under TSCA Contact Us
Reviewing New Chemicals under TSCA Contact Us to ask a question, provide feedback, or report a problem.
Last updated on March 11, 2024
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