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July 10, 2023

NASEM Report Recommends that EPA Develop Framework for Evaluating NAMs for Toxicity Testing

Lynn L. Bergeson

On June 16, 2023, the National Academies of Sciences, Engineering, and Medicine (NASEM) announced the release of a new report providing an overview of new approach methods (NAM) in human health risk assessment of chemicals and calling on the U.S. Environmental Protection Agency (EPA) to develop a framework for evaluating and building trust in NAMs. NASEM states that some pollutants, such as lead, benzene, and ozone, are well studied, enabling EPA to characterize their hazards and risks to human health. For many chemicals in commerce and in the environment, such as per- and polyfluoroalkyl substances (PFAS), there are little or no data on their potential health effects, however. As a result, only a small fraction of chemicals and other toxicants to which people are exposed have undergone formal assessment of hazards and risks by EPA.
NASEM notes that EPA uses various types of data to inform its human health risk assessments, but states that studies employing laboratory testing on mammals still serve as the foundation for most assessments. NAMs draw on a range of novel alternative tests, strategies, and models. According to NASEM, NAMs “have the potential to fill the gaps when traditional data are not available, and to improve traditional assessments by expanding the understanding of toxic response.”
According to NASEM, many barriers to the use of NAMs remain. The report calls on EPA to expand its definition of “new approach methods” to encompass the wide range of strategies and approaches available that could address critical human health risk assessments. NASEM states that the report “draws on lessons learned from laboratory mammalian toxicity tests to help inform approaches for building scientific confidence in new approach methods, and offers recommendations to move new approach methods from evaluation in the laboratory to their incorporation into modern, systematic-review-based risk assessments.”