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EPA NAM Work Plan to Reduce Use of Animals in Chemical Testing

On June 24, 2020, the U.S. Environmental Protection Agency (EPA) released a New Approach Methods (NAM) Work Plan that will “serve[] as a roadmap for meeting its animal testing reduction goals set forth in Administrator Andrew Wheeler’s 2019 Directive.”  According to EPA’s June 24, 2020, press release, the Work Plan describes how EPA plans to develop, test, and apply chemical safety testing approaches that reduce or replace the use of animals.  EPA states that compared to traditional animal testing, NAMs allow researchers better to predict potential hazards for risk assessment purposes without the use of traditional methods that rely on animal testing.  The objectives of the Work Plan include:

  • Evaluating regulatory flexibility for the use of NAMs;
     
  • Establishing baselines and metrics for assessing progress;
     
  • Developing NAMs that fill critical information gaps;
     
  • Establishing scientific confidence in NAMs;
     
  • Demonstrating NAMs application to regulatory decisions; and
     
  • Engaging with stakeholders to incorporates their knowledge and address their concerns regarding EPA’s phaseout of mammalian testing.

EPA states that the Work Plan will evolve as EPA’s knowledge and experience grow and as outside experts offer their perspectives and contributions.  EPA will regularly review the Work Plan to ensure that the efforts involved provide the best path to success.  More information on the 2019 directive to prioritize efforts to reduce animal testing is available in our September 11, 2019, blog item, “EPA Administrator Signs Directive Intended to Reduce Animal Testing, Awards $4.25 Million for Research on Alternative Methods to Animal Testing.”

©2020 Bergeson & Campbell, P.C.National Law Review, Volume X, Number 189

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About this Author

Lynn Bergeson, Campbell PC, Toxic Substances Control Act Attorney, federal insecticide lawyer, industrial biotechnology legal counsel, Food Drug Administration law
Managing Partner

Lynn L. Bergeson has earned an international reputation for her deep and expansive understanding of the Toxic Substances Control Act (TSCA), the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), European Union Registration, Evaluation, Authorization and Restriction of Chemicals (REACH), and especially how these regulatory programs pertain to nanotechnology, industrial biotechnology, synthetic biology, and other emerging transformative technologies. Her knowledge of and involvement in the policy process allows her to develop client-focused strategies whether...

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Carla Hutton, Bergeson Campbell PC, global regulatory attorney, public health activists lawyer, metals industry legal counsel, Toxic Substances Control Act law
Regulatory Analyst

Since 1996, Carla Hutton has monitored, researched, and written about regulatory and legislative issues that may potentially affect Bergeson & Campbell, P.C. (B&C®) clients. She is responsible for creating a number of monthly and quarterly regulatory updates for B&C's clients, as well as other documents, such as chemical-specific global assessments of regulatory developments and trends. She authors memoranda for B&C clients on regulatory and legislative developments, providing information that is focused, timely and applicable to client initiatives. These tasks have proven invaluable to many clients, keeping them aware and abreast of developing issues so that they can respond in kind and prepare for the future of their business.

Ms. Hutton brings a wealth of experience and judgment to her work in federal, state, and international chemical regulatory and legislative issues, including green chemistry, nanotechnology, the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), the Toxic Substances Control Act (TSCA), Proposition 65, and the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) program.

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