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

Points to Consider When Preparing TSCA New Chemical Notifications

Below is EPA's "Points to Consider When Preparing a TSCA New Chemical Notification" guidance, which provides the general public, especially new chemical submitters, with important information on: 

  • general guidance relating to new chemical notices;
  • preparation of Pre-manufacture Notices, Significant New Use Notices, and Exemption notices;
  • EPA scientific approaches; and
  • best practices.

This document was updated in June 2018 to reflect comments received from the public and interested stakeholders. EPA’s response to these comments is below. To view the draft version of the "Points to Consider When Preparing TSCA New Chemical Notifications" guidance that was published for comment visit the webpage on EPA’s December 2017 public meeting on implementation of the new chemicals review program.

EPA issued a Federal Register notice describing EPA’s request for processing the information collection request amendment for TSCA section 5 information on an emergency basis.  This notice is necessary to make the "Points to Consider" guidance consistent with requirements of the Paperwork Reduction Act.

  • Updated June 2018: Points to Consider When Preparing TSCA New Chemical Notifications (pdf) (388 KB, June, 2018)
  • Response to Comments Received on Points to Consider (pdf) (248.62 KB, June, 2018)

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 March 10, 2025
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