Skip to main content
U.S. flag

An official website of the United States government

Here’s how you know

Dot gov

Official websites use .gov
A .gov website belongs to an official government organization in the United States.

HTTPS

Secure .gov websites use HTTPS
A lock (LockA locked padlock) or https:// means you’ve safely connected to the .gov website. Share sensitive information only on official, secure websites.

    • Environmental Topics
    • Air
    • Bed Bugs
    • Cancer
    • Chemicals, Toxics, and Pesticide
    • Emergency Response
    • Environmental Information by Location
    • Health
    • Land, Waste, and Cleanup
    • Lead
    • Mold
    • Radon
    • Research
    • Science Topics
    • Water Topics
    • A-Z Topic Index
    • Laws & Regulations
    • By Business Sector
    • By Topic
    • Compliance
    • Enforcement
    • Laws and Executive Orders
    • Regulations
    • Report a Violation
    • Environmental Violations
    • Fraud, Waste or Abuse
    • About EPA
    • Our Mission and What We Do
    • Headquarters Offices
    • Regional Offices
    • Labs and Research Centers
    • Planning, Budget, and Results
    • Organization Chart
    • EPA History

Breadcrumb

  1. Home
  2. Safer Chemicals Research

EPA New Approach Methods: Efforts to Reduce Use of Vertebrate Animals in Chemical Testing

News & Updates

  • Join EPA NAMs email list for updates

The Environmental Protection Agency is prioritizing ongoing efforts to develop and use New Approach Methods (NAMs) to test chemicals for health effects. Using NAMs will help reduce the use of vertebrate animals in chemical testing while ensuring protection of human health and the environment.

The definition of NAMs has evolved over time. Currently, it is broadly descriptive reference to any non-vertebrate animals technology, methodology, approach, or combination thereof that can be used to provide information on chemical hazard and risk assessment. These include in vitro tests, in chemico assays, and in silico models. NAMs are functionally equivalent to “alternatives" to mammal testing.

On this page:
  • Why Develop New Approach Methods?
  • NAMs Research Approaches
  • Additional Resources

Why Develop New Approaches?

EPA uses many types of information to evaluate the potential risks of chemicals to human and ecological health. Due to the large number of chemicals regulated by EPA, better, faster, and more cost effective methods are needed for chemical evaluation. Associated with this need, is the goal of reducing, refining, and replacing the use of animals in testing. The increased application of NAMs holds the potential of meeting both the need and the goal.

NAMs Research Approaches

EPA’s Office of Research and Development (ORD) is actively developing, testing and applying NAMs to improve Agency approaches to evaluate the potential impacts of chemicals on human and ecological health. Working collaboratively with federal partners and other stakeholders, EPA is developing NAMS that will provide data to fill critical information gaps and build confidence for the use of these new approaches in regulatory decisions. EPA has developed a three-part strategy that: 1) characterizes the scientific quality and relevance of existing animal tests, 2) develops recommended reporting requirements, and 3) demonstrates application of the NAMs to regulatory decisions through case studies. These efforts are focused on developing information of “equivalent or better” scientific quality and relevance to animal test-based results.

researcher working on New Approach Methods

High-Throughput Toxicology

ORD has developed a computational NAM model to evaluate potential estrogenic activity for the Agency’s Endocrine Disruptor Screening Program (EDSP). The model is being used to evaluate the potential estrogenic activity of over 1800 environmental chemicals and will reduce the use of low-throughput in vitro and in vivo assays. Looking forward, EPA will continue to modernize the EDSP by developing: computational models for estrogen receptor activity, androgen receptor activity, and steroidogenesis; high-throughput thyroid assays and associated models; species extrapolation approaches; and interactive dashboard tools, such as the CompTox Chemicals Dashboard, for data interpretation, translation, and chemical prioritization. Learn more about High-Throughput Toxicology research.

Virtual Tissue Models

Chemical assessments include consideration of risks to vulnerable subpopulations and life stages. NAMs help to address potential adverse developmental outcomes that reflect the best available knowledge of human developmental biology and do so with less reliance on traditional animal testing. EPA is exploring evaluating the effects of chemical exposure during human development on phenotypic responses in human-based in vitro and virtual tissue model systems to predict chemical hazard. In addition, EPA is developing and applying in silico virtual tissue models, agent-based models, and organotypic cell culture models to evaluate and model the effects of chemicals on reproductive and developmental endpoints. Learn more about Virtual Tissue Model research.

Adverse Outcome Pathways

Successful adoption and use of NAMs in risk assessments and regulatory decision making depends upon developing confidence that new methods and approaches provide equivalent or better scientific quality and relevance compared to existing approaches. To achieve this confidence, an understanding of both chemistry and biology is needed to establish the scientific rationale that support the use of NAMs in evaluating potential chemical impacts. EPA is actively developing Adverse Outcome Pathways (AOPs) for high-priority pathways and chemicals, designing relevant case studies, and disseminating the results through an AOP knowledgebase. Additionally, EPA is conducting in vitro and in vivo studies for high-priority AOPs to support predictive model development. EPA’s work on AOP will help to understand and define biological points of departure, actionable effect levels, and susceptibility factors for important chemicals of interest. Learn more about Adverse Outcome Pathways research.

Additional Resources

  • List of NAMs per Section 4(h)(2)(C) of TSCA
  • Alternative Toxicity Testing Report to Congress
  • TSCA Alternative to Mammal Testing
  • Pesticides
  • Work Plan

    Prioritizing agency efforts to reduce vertebrate animal testing.

    EPA New Approach Methods Work Plan
  • Conferences

    EPA will be hosting the 4th NAMs Conference November 5-6, 2024.

    EPA NAMs Conferences
  • Training

    Access resources like recordings, worksheets, and user guides for EPA NAMs tools.

    Catalog of Training Materials

Safer Chemicals Research

  • Chemical Evaluation & Characterization
    • High-Throughput Toxicology
    • Rapid Exposure & Dosimetry
    • Emerging Materials and Technology
    • Chemical Characterization and Informatics
  • Complex Systems Science
    • Adverse Outcome Pathways
    • Virtual and Complex Tissue Models
    • Ecotoxicological Assessment and Modeling
  • Translation, Training, & Tools
  • New Approach Methodologies Research
    • NAMs Research
    • NAMs Work Plan
    • NAMs Training
      • Getting Started
      • Tool Tips
      • NAMs Training Contact
    • NAMs Conferences
  • Chemical Research to Inform Decision Making
  • Collaborations & Funding
    • Collaborative Agreements
Contact Us About Chemical Safety Research
Contact Us to ask a question, provide feedback, or report a problem.
Last updated on June 25, 2024
  • Assistance
  • Spanish
  • Arabic
  • Chinese (simplified)
  • Chinese (traditional)
  • French
  • Haitian Creole
  • Korean
  • Portuguese
  • Russian
  • Tagalog
  • Vietnamese
United States Environmental Protection Agency

Discover.

  • Accessibility Statement
  • Budget & Performance
  • Contracting
  • EPA www Web Snapshot
  • Grants
  • No FEAR Act Data
  • Plain Writing
  • Privacy
  • Privacy and Security Notice

Connect.

  • Data
  • Inspector General
  • Jobs
  • Newsroom
  • Regulations.gov
  • Subscribe
  • USA.gov
  • White House

Ask.

  • Contact EPA
  • EPA Disclaimers
  • Hotlines
  • FOIA Requests
  • Frequent Questions
  • Site Feedback

Follow.