EPA Releases Updated New Approach Methodologies (NAMs) Work Plan

Published January 19, 2022

For years, EPA scientists have been using cutting edge New Approach Methodologies (NAMs) to reduce the use of animals and revolutionize chemical testing. NAMs refer to any technologies, methodologies, approaches, or combinations thereof that can be used to provide information on chemical hazard and potential human exposure that can avoid or significantly reduce the use of testing on animals.

In 2016, the Toxic Substances Control Act was amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act, directing EPA to “reduce and replace... the use of vertebrate animals in the testing of chemical substances or mixtures; and promote the development and timely incorporation of alternative test methods or strategies that do not require new vertebrate animal testing.” 

EPA’s Office of Research and Development (ORD) and Office of Chemical Safety and Pollution Prevention (OCSPP) developed and released the EPA NAM Work Plan. The Work Plan outlined objectives, strategies, and deliverables for incorporating NAMs into our research and regulatory programs. The Work Plan was developed to evolve as EPA’s knowledge and experience grows, and as outside experts offer their perspectives and contributions to the work. 

On December 3, 2021, EPA released an updated NAMs Work Plan. The plan describes EPA’s near and long-term strategies it will deploy through 2024 for continuing to establish scientific confidence in NAMs and to show how NAMs can be applied to regulatory decisions. 

This new Work Plan includes five primary changes. 

• Expansion of the species covered in the work plan to include all vertebrate animals to be consistent with TSCA.
• Modified deliverables that provide revised timelines through 2024 that reflect the expansion of covered species and incorporation of feedback received over preceding years.
• Updated scope of the U.S. National Academies of Sciences, Engineering, and Medicine study to include a review of validation and scientific confidence frameworks for NAMs in addition to evaluating the variability and relevance of existing mammalian toxicity tests. This study will be evaluating the variability and relevance of existing mammalian toxicity tests and reviewing frameworks for validation and establishing scientific confidence in testing methods. The study is funded by the EPA, but the timing is determined by the National Academies and is currently scheduled for 2023.
• Two new case studies for building confidence and demonstrating application of NAMs.
  • Utilization of a NAM Battery for Evaluation of Developmental Neurotoxicity (DNT) Potential: Incorporation of a battery of in vitro assays that assess processes critical to the development of the nervous system into the weight of evidence evaluation of DNT potential for a chemical
  • Evaluating In Vitro and In Silico Toxicokinetic Approach: Evaluating the uncertainties and predictivity of in vitro and in silico toxicokinetic data and computational models
• A pilot study to develop NAMs training courses and materials for a broad range of stakeholders.

EPA is committed to the use of the best available science to protect public health and the environment, and in many situations NAMs furthers that commitment by providing more relevant science to inform EPA decisions. EPA will reduce animal testing as expeditiously as possible subject to establishing that the NAMs can feasibly and appropriately replace existing methods. 

Learn More

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

EPA New Approach Methods Work Plan: Reducing Use of Vertebrate Animals in Chemical Testing

Alternative Test Methods and Strategies to Reduce Vertebrate Animal Testing