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

EPA's Review Process for New Chemicals


New Chemicals Program meetings and review process

The Premanufacture Notice (PMN) Program to review new chemicals under the Toxic Substances Control Act (TSCA) has evolved into an efficient mechanism for identifying those new chemicals which are of greatest concern early on in the 90-day review process. A detailed analysis is focused on these cases with the ultimate goal of identifying and controlling unreasonable risks. EPA uses an integrated approach that draws on knowledge and experience across disciplinary and organizational lines to identify and evaluate concerns regarding health and environmental effects, exposure and release and economic impacts.

Following receipt of a PMN or exemption notice, EPA scientists and program managers meet to evaluate the notice and the notice undergoes the following steps in the Agency's 90-day review process. View the graphic of the new chemicals review process below.

 Flowchart with PMN process steps

 Confirmation that PMN has been received by EPA Incomplete PMNInvalid PMNRegulatory Determination EPA Actions to Reduce RisksReview Process

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Chemical categories used to review new chemicals

EPA groups PMN chemicals with shared chemical and toxicological properties into categories in order to streamline the process for Agency review of new chemical substances.

Learn more about the New Chemicals chemical categories.

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Predictive Models and Tools for Assessing Chemicals under the Toxic Substances Control Act (TSCA)

EPA has developed assessment methods, databases, and predictive tools to help evaluate what happens to chemicals when they are used and released to the environment and how workers, citizens, and the environment might be exposed to and affected by them. These tools may be helpful when laboratory studies or monitoring data are not available or need to be supplemented.

Learn more about the predictive tools and models used in the New Chemicals Program.

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