U.S.: EPA Strengthens Oversight of New Chemicals Under TSCA

TSCA as the Foundation of U.S. Chemical Regulation

The Toxic Substances Control Act (TSCA) is the primary U.S. legislation governing industrial chemicals. It regulates the entire lifecycle of chemical substances, from manufacturing and import to processing, use, and disposal. In addition, the law grants the U.S. Environmental Protection Agency (EPA) broad authority to require information on substances, evaluate potential risks, and impose additional requirements or use restrictions where necessary. 

A key component of TSCA is the TSCA Inventory, which lists existing chemical substances permitted for commerce in the United States. Chemicals not listed on the Inventory are generally considered new substances, unless they are specifically exempt from TSCA, such as medicines. Before such substances may be manufactured or imported, companies must submit information on their intended commercialization and use to the EPA through a Premanufacture Notice (PMN). Based on its review, the EPA may impose conditions through Consent Orders or establish Significant New Use Rules (SNURs) requiring certain new uses of a substance to be reported and reviewed prior to commencement. Companies intending to engage in an activity designated as a „significant new use“ must submit a Significant New Use Notification (SNUN) to the EPA at least 90 days before beginning the activity.

New SNURs Expand Existing Protective Measures

The SNURs adopted by the EPA apply to 35 substances that were previously evaluated under the Agency’s New Chemicals Program through the PMN process. For all affected substances, TSCA Section 5(e) Consent Orders are already in place, imposing specific protective measures and use restrictions on the original submitters. 

With the finalization of these SNURs, the existing requirements are now extended to additional companies seeking to manufacture or process the substances in question. Such companies must submit a SNUN to the EPA before commencing any activity classified as a significant new use. This provides the Agency with an opportunity to reassess potential risks and, where appropriate, require additional risk management measures.

Implications for the Chemical Industry

Companies should therefore review their TSCA compliance procedures on a regular basis and pay particular attention to requirements associated with PMNs, SNUNs, and existing Consent Orders. This is especially important when new uses are planned or when manufacturing and processing conditions are modified.

By introducing these new SNURs, existing protective measures are being extended to a broader range of market participants, while the EPA gains additional opportunities to evaluate potential risks associated with new uses before they occur. 

For companies, this means that maintaining regulatory compliance remains a key challenge when placing new substances on the market and throughout their subsequent use.

We support companies in assessing their regulatory obligations in the United States, navigating PMN, SNUN, and other TSCA procedures, and developing effective compliance strategies for the U.S. market. With our regulatory expertise , we help businesses efficiently implement new requirements and minimize compliance risks throughout the supply chain. 

For more information, please contact us at  sales@kft.de or use our contact form.

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