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EPA trying to streamline toxic risk assessment for new mixed metal oxides with applications in batteries, EVs

The US Environmental Protection Agency (EPA) announced a new effort under the Toxic Substances Control Act (TSCA) to implement a streamlined and efficient process under the New Chemicals Program to assess risk and apply mitigation measures, as appropriate, for new chemicals with applications in batteries, electric vehicles, semiconductors and renewable energy generation.

The Toxic Substances Control Act of 1976—the primary chemicals management law in the US—provides EPA with authority to require reporting, record-keeping and testing requirements, and restrictions relating to chemical substances and/or mixtures. In 2016, TCSA was amended by the Lautenberg Chemical Safety Act (signed into law by President Obama).

The amended law includes improvements to TCSA such as:

  • Mandatory requirement for EPA to evaluate existing chemicals with clear and enforceable deadlines;

  • Risk-based chemical assessments;

  • Increased public transparency for chemical information; and

  • Consistent source of funding for EPA to carry out the responsibilities under the new law.

In February 2022, EPA launched a new effort—the New Chemicals Program—under TSCA to modernize the process further and to bring innovative science to the review of new chemicals before they can enter the marketplace.

The new process is for mixed metal oxides (MMOs), including new and modified cathode active materials (CAMs). MMOs typically consist of lithium, nickel, cobalt and other metals, and they are the key material used in the production of the cathode in battery cells. New MMOs can also be used for semiconductors, and renewable energy generation and storage, such as solar cells and wind power turbines.

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 assess all the potential hazards and exposures of the new chemical substance fully, 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.

EPA has reviewed hundreds of TSCA section 5 submissions for MMOs, including CAMs and modified CAMs, since the 1980s. To describe this new effort further, EPA will launch outreach and training for interested stakeholders to outline the new streamlined approach to reviewing MMOs, basics of TSCA statutory and regulatory requirements, and steps for navigating the new chemicals submission process.

EPA also released a Compliance Advisory reaffirming that new MMOs, which includes 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.

The TSCA Inventory is a list of chemical substances manufactured (including imported) or processed in the United States that do not qualify for an exemption or exclusion under TSCA. The Inventory now has more than 86,000 chemicals.

In January 2022, EPA launched a similar effort to streamline the review of dozens of PMNs for biofuels that could be used to displace current, higher greenhouse gas emitting transportation fuels. Under this effort, EPA has completed about 95% of all biofuel PMNs submitted since the initiative was announced.

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