2018 Forecast on U.S. and International Chemical Regulatory Policy

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2018 Forecast on U.S. and International Chemical Regulatory Policy

Bergeson & Campbell, P.C. and its consulting affiliate The Acta Group have published their expert-based forecast of US and international regulatory policy for 2018. “The document distills key trends in U.S. and global chemical law and regulation, and provides a sneak preview of what our legal, scientific, and regulatory professionals believe we are likely to see in the New Year.”

The report includes the following section on EPA’s implementation of animal alternative test methods:

Strategic Plan to Promote and Implement Alternative Testing Methods

TSCA Section 4(h) requires that EPA take several steps that can contribute to reducing and replacing the use of vertebrate animals in testing “to the extent practicable, scientifically justified, and consistent with the policies” of TSCA. Among others, the provision requires EPA within two years of enactment to develop a strategic plan to promote the development and implementation of alternative test methods and strategies. EPA, in a November 2017 public meeting, proposed to group the array of computational, Structure Activity Relationships (SAR), in silico, in vitro, and other alternative methods under the term New Approach Methodologies (NAM). We were pleased to see the results from EPA’s early thinking on this issue and look forward to seeing more development of the approaches and concepts. Challenges remain for EPA to sort out issues regarding its scientific acceptance of NAM results for screening versus assessment purposes, and its willingness to accept such test methods to meet legal testing requirements under Sections 4 and 5 of TSCA.