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

EPA's Review Process for New Chemicals

On this page:
  • New Chemicals Program meetings and review process
  • Chemical categories used to review new chemicals
  • Predictive models and tools for assessing chemicals under TSCA
  • New chemicals and pollution prevention efforts
  • Policies, frameworks, and guidance
On other pages:
  • Changes to EPA’s review of new chemicals due to 2016 TSCA amendments

New Chemicals Program meetings and review process

On June 22, 2016, the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Chemical Safety Act) was signed into law. The Lautenberg Chemical Safety Act amends the Toxic Substances Control Act (TSCA), the nation's primary chemicals management law. Under the new law, EPA is required to make an affirmative determination on whether each new chemical substance, for which it received a notice under Section 5(a)(1), presents an unreasonable risk to human health or the environment under known, intended or reasonably foreseen conditions of use. EPA uses a standardized 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.

Read what happens at each stage of the EPA review process.

Confirmation that PMN has been received by EPAIncomplete PMNInvalid PMNRegulatory DeterminationEPA Regulatory ActionsReview Process


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.


Predictive models and tools for assessing chemicals under 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.


New chemicals and pollution prevention efforts

The New Chemicals Program is actively carrying out EPA's strategy to prevent pollution before it can occur. The New Chemicals Program strongly encourages industry efforts to prevent pollution. 

Learn more about these pollution prevention efforts.


Policies, frameworks, and guidance

  • Chemistry assistance manual
  • Instruction manual for reporting under the New Chemicals Program
  • Questions and answers for the New Chemicals Program under TSCA
  • Consolidation of PMNs and exemption applications policy
  • Exclusions and exemptions from PMN requirements
  • Exposure-based policy
  • High molecular weight polymers policy
  • Incomplete PMNs
  • Control of nanoscale materials under TSCA
  • New Chemical Exposure Limits
  • Persistent Bioaccumulative Toxics policy
  • Sustainable Futures
  • TSCA Inventory policies
  • New Chemicals "Working Approach" Framework
  • Points to Consider When Preparing TSCA New Chemical Notifications
  • Framework for Addressing New PFAS and New Uses of PFAS
  • Decision Framework for Eye Irritation/Corrosion Hazard Identification

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 October 15, 2024
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