New Approach Methods (NAMs) for Human Health Risk Assessment Proceedings of a Workshop–in Brief (2022) / Chapter Skim
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New Approach Methods (NAMs) for Human Health Risk Assessment: Proceedings of a Workshop - in Brief
New Approach Methods (NAMs) for Human Health Risk Assessment: Proceedings of a Workshop - in Brief
Pages 1-11
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• What do we know about the variability and concordance of traditional mammalian toxicity studies? • What are the needs and expectations of different stakeholders?
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There are multiple types of risk assessment, ranging from screening assessments to comprehensive high-level assessments that present a synthesis of the evidence including human, animal, and other toxicity testing, including NAMs. Laboratory mammalian toxicity testing has been the cornerstone of risk science, providing a strong correlation with human disease, including cancer.
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The framework recommended in the 2015 report proposes a variety of data and models as tools to support a prioritization strategy to address the acute toxicity of chemicals, noting that traditional mammalian toxicity studies would be preferred when other approaches were deemed inadequate. Dorman discussed the inherent policy decisions embedded in the conceptual frameworks offered in both reports, for example, assigning chemicals to categories, the level of evidence required to make reliable decisions, and a reliance on surrogate outcomes.13 Panel Discussion Several panelists noted that animal studies are the cornerstone of the current practice of risk assessment.
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Burke added that regarding NAMs, "once we get to that actionable evidence, we have to be prepared to defend it. And to be very transparent about the inherent limitations of all types of data." UNDERSTANDING THE VARIABILITY OF TRADITIONAL MAMMALIAN TOXICITY STUDIES WITH DIFFERENT LEVELS OF COMPLEXITY Nicole Kleinstreuer, NTP Interagency Center for the Evaluation of Alternative Toxicological Methods, and Holly Davies, Washington State Department of Health, moderated a panel on the variability of traditional mammalian toxicity studies.
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Panel Discussion Kleinstreuer and Davies led a discussion around the variability of traditional mammalian toxicity studies. Allen observed that regulators have indicated that they have strong confidence in in vivo studies to inform specific hazard identification or comprehensive risk assessments.
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EXAMINING THE CONCORDANCE OF TRADITIONAL MAMMALIAN TOXICITY STUDIES WITH HUMANS Patience Browne, Organisation for Economic Co-operation and Development, and Nancy Lane, University of California, Davis, moderated a session on understanding the concordance of traditional mammalian toxicity studies with humans. Thomas Hartung, Johns Hopkins University, discussed the concordance of traditional mammalian toxicity studies with clinical human outcomes.
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Dorman presented the findings from the 2017 National Academies report Application of Systematic Review Methods in an Overall Strategy for Evaluating Low-Dose Toxicity from Endocrine Active Chemicals.24 The committee responsible for the report was tasked with developing a strategy to evaluate the evidence of adverse human health effects from low doses of exposure to chemicals that can disrupt the endocrine system. It was also tasked with conducting systematic reviews of animal and human toxicology data for phthalates and polybrominated diphenyl ethers (PBDEs)
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For the other outcomes, incidence of hypospadias, and lower fetal testosterone, the human data were found to be inadequate to draw conclusions. Regarding concordance between phthalates and AGD, Dorman noted that current testing methods can identify a hazard that is presumed to be of concern to humans but might not be able to accurately predict exposures at which humans are affected.
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Joglekar noted that animal studies play a critical role in examining complex health outcomes and it will be difficult to replace this with NAMs. The current NAMs tests in the neurotoxicity space can be used to complement current animal tests, but not replace gold standard testing protocols or to establish the safety of chemicals.
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One opportunity noted by the panelists is to shift risk assessment to probabilistic methods to quantify risk. Following the final panel discussion, the public offered its comments to the committee and workshop panelists.
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