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Building Confidence in New Evidence Streams for Human Health Risk Assessment Lessons Learned from Laboratory Mammalian Toxicity Tests (2023) / Chapter Skim
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Appendix D: Selected Examples of Scientific Confidence Frameworks for NAMs
Pages 152-158

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From page 152...
... NRC, 2007 The report aimed to "review the state of the science and create a The report includes a framework that includes key questions to address in far-reaching vision for the future of toxicity testing," with the aim implementation. The areas and concerns covered include the following: to create more "informed environmental regulations and • Identify key pathways, including multiple pathways, leading to toxicity.
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From page 153...
... frameworks are essential for the successful • Address data quality and coverage. use of NAMs and integration of the information they provide." OECD, 2017 In 2017, the OECD published guidance for describing "non- This guidance includes a framework for describing a test method that outlines guideline in vitro test methods" whose purpose was to "harmonise the type and level of information that would ideally be reported, and includes the way non-guideline in vitro methods are described." the following sections: • General information • Test method definition • Data interpretation and prediction model • Test method performance • Potential regulatory applications.
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From page 154...
... Consumer Product Safety Commission published 1. Independent scientific peer review Product Safety guidance on the regulatory evaluation of NAMs and associated 2.
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From page 155...
... NAMs that can reduce or eliminate reliance on direct comparison 2. Human biological relevance with respect to human biological to currently used animal test methods, and thereby enable better information (physiology, mechanisms of toxicity)
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From page 156...
... van der Zalm et 3. Technical characterization, including accuracy, al., 2022 reproducibility/transferability, applicability domain, reference chemicals and controls, and limits of detection/quantification 4.
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From page 157...
... 2022. "Final Guidance for Industry and Test Method Developers: CPSC Staff Evaluation of Alternative Test Methods and Integrated Testing Ap proaches and Data Generated from Such Methods to Support FHSA Labeling Require ments." CPSC 87 FR 18772: 2022–06825.
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Key Terms

  • scientific confidence
  • test method
  • der zalm
  • approach methodologies
  • alternative test

  • animal test
  • product safety
  • applicability domain
  • strategic roadmap
  • defined approaches

  • joint research
  • vitro test
  • european chemicals
  • transparently described
  • independent scientific

  • toxicity pathways
  • human biological
  • coordinating committee
  • design tests
  • animal testing

  • chemicals agency
  • eight criteria
  • defined criteria
  • biological relevance
  • vivo data

  • consumer product
  • safety commission
  • method evaluation
  • tive test
  • affects biologic


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