Building Confidence in New Evidence Streams for Human Health Risk Assessment

As part of its core mission, the U.S. Environmental Protection Agency(EPA) is tasked with assessing the hazards and risks to human healthfrom exposure to pollutants. While some pollutants are well studied,there are little or no data on the potential health effects for manythousands of chemicals that can make their way into the environment,such as PFAS.EPA still relies on laboratory mammalian studies as thefoundation of most human health risk assessments, which are limited byhigh costs, long timelines, and other concerns. New approach methods(NAMs) in toxicology, for example new in vivo and in vitro strategiesand computational systems biology, offer opportunities to inform timelydecision-making when no data are available from laboratory mammaliantoxicity tests or epidemiological studies. NAMs may also help informefforts to protect susceptible and vulnerable populations bycharacterizing subtle health perturbations, better encompassing geneticdiversity, and accounting for nonchemical stressors. While the promise and need for NAMs is clear, many barriers to theiruse remain. This report aims to bridge the gap between the potential ofNAMs and their practical application in human health risk assessment.Building Confidence in New Evidence Streams for Human Health RiskAssessment draws lessons learned from laboratory mammalian toxicitytests to help inform approaches for building scientific confidence inNAMs and for incorporating such data into risk assessment anddecision-making. Overall, the report recommendations aim to ensure aseamless handoff from the evaluation of NAM-based testing strategies inthe laboratory to the incorporation of NAM data into modern,systematic-review-based risk assessments.