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

Approach to Making Determinations on TSCA Section 5 New Chemical Notices

The document below explains EPA’s working approach to making determinations on new chemical notices received under section 5 of the Toxic Substances Control Act (TSCA).

As part of EPA’s evaluation of its policies, guidances, templates, and regulations in the TSCA New Chemicals program. EPA is seeking to better align the decision-making process for new chemicals with the requirements of TSCA.  As such, EPA has recently made some changes in implementation of the new chemicals programs and will continue to evolve its approach for making determinations and managing risks associated with new chemical notices under TSCA section 5.  As a result of these changes, portions of the 2019 “Working Approach” are no longer reflective of the Agency’s current process and approach.  While the Agency considers whether further program implementation changes may be appropriate, we will continue to be transparent about these changes.  Interested stakeholders can follow EPA announcements and/or subscribe to our email list by visiting our website. Further, companies are encouraged to work with EPA staff if they have any questions regarding these changes and any potential impacts to their TSCA section 5 notices and/or exemption submissions.

  • Approach to Making Determinations on TSCA Section 5 New Chemical Notices (pdf) (365.19 KB)

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
Contact Us to ask a question, provide feedback, or report a problem.
Last updated on June 3, 2024
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