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A framework for establishing scientific confidence in new approach methodologies.

Anna J van der Zalm1, João Barroso2, Patience Browne3

  • 1PETA Science Consortium International e.V., Stuttgart, Germany. AnnaZ@thepsci.eu.

Archives of Toxicology
|August 20, 2022
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Summary

Establishing scientific confidence in new approach methodologies (NAMs) requires a framework focusing on fitness for purpose, human biological relevance, and transparency for regulatory acceptance. This ensures NAMs provide reliable, human-relevant data for health protective decisions.

Keywords:
FrameworkHuman healthNAMsNew approach methodologiesRegulatoryValidation

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Area of Science:

  • Toxicology
  • Regulatory Science
  • Biotechnology

Background:

  • New Approach Methodologies (NAMs) are increasingly important for assessing chemical safety.
  • Regulatory acceptance of NAMs requires robust processes to establish scientific confidence.
  • Current challenges include ensuring NAMs are fit for purpose and relevant to human biology.

Purpose of the Study:

  • To propose a comprehensive framework for establishing scientific confidence in NAMs for regulatory applications.
  • To outline essential elements for developing and implementing NAMs for human health risk assessment.
  • To facilitate the international adoption and use of NAMs in regulatory decision-making.

Main Methods:

  • Development of a five-element framework: fitness for purpose, human biological relevance, technical characterization, data integrity and transparency, and independent review.
  • Emphasis on stakeholder communication (regulators, industry) to define NAM purpose and context.
  • Focus on biological relevance through alignment with human biology and mechanistic understanding.

Main Results:

  • The proposed framework provides a structured approach to build scientific confidence in NAMs.
  • The framework emphasizes human biological relevance over direct comparison with animal test results.
  • Consideration of variability in historical animal test data is recommended for performance benchmarks.

Conclusions:

  • Adoption of this framework will accelerate the development and regulatory use of NAMs globally.
  • The framework is applicable to assessing human health effects of pesticides and industrial chemicals.
  • Key elements are adaptable for other chemical assessments and ecotoxicological evaluations.