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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1 Introduction
1 Introduction
Pages 14-20
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From page 14... ...
Accordingly, the EPA asked NASEM specifically to review the variability and relevance of existing laboratory mammalian toxicity tests for human health risk assessment to inform development of approaches for validation and establishing scientific confidence in NAMs. To that end, NASEM convened the Committee on Variability and Relevance of Current Laboratory Mammalian Toxicity Tests and Expectations for New Approach Methods for Use in Human Health Risk Assessment.
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with a review of the variability and relevance of existing laboratory mammalian toxicity tests for human health risk assessment to inform the de velopment of approaches for validation and establishing scientific confidence in using New Ap proach Methods (NAMs) , and recommendations on expectations associated with NAMs when they cannot be compared with human studies.
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From page 16... ...
In addition, various information gathering sessions were conducted to solicit input from sponsor representatives and members of the public, including during two virtual workshops involving experts from academia, industry, the government, and other organizations. The published reviews and analyses of data on variability and concordance of mammalian toxicity tests that were identified during the open sessions of the committee, including the two public workshops, were compiled and evaluated.
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. Thus, the committee conducted an overview review to identify and evaluate systematic reviews and authoritative reviews1 of the scientific evidence of the highest methodological quality relevant to the committee's 1 The committee defines authoritative reviews as reviews produced by governmental agencies and international agencies (i.e., EPA, National Toxicology Program, U.S.
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Systematic reviews and authoritative reviews of higher methodological quality formed the evidentiary basis analyzed by the committee in reaching findings and recommendations that addressed the charge questions. Overall, this approach is consistent with the goal specified in the committee's charge for a "comprehensive, workable, objective, and transparent process." In addition, the approach is consistent with guidance from NASEM, in multiple reports, to use systematic reviews as a transparent and robust methodology to evaluate the environmental health scientific literature in support of hazard and risk assessment conclusions (NASEM, 2019, 2022d)
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In addressing charge questions 4–5, the committee determined that a more overarching framework was needed involving structured, multifactor evaluations of scientific confidence, rather than considering individual factors in isolation. In addition, to ensure coherence and consistency with previous NASEM reports, the committee integrated previous findings and recommendations into its deliberations, such as those related to the role of systematic review and the risk assessment approaches needed to adequately protect public health.
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for Human Health Risk Assessment | Meeting 12." Washington, DC, July 28. https://www.nationalacademies.org/event/07-28-2022/new approach-methods-nams-for-human-health-risk-assessment-meeting-12.
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