A new National Academies of Sciences, Engineering, and Medicine report provides an overview of new approach methods in human health risk assessment of chemicals, and calls on the U.S. Environmental Protection Agency to develop a framework for evaluating and building trust in new approach methods.  

Some pollutants such as lead, benzene, and ozone are well studied, enabling the EPA to characterize their hazards and risks to human health. However, for many chemicals in commerce and in the environment, such as PFAS, there is little or no data on their potential health effects. 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 the EPA.  

The EPA uses various types of data to inform its human health risk assessments, but studies that employ laboratory testing on mammals still serve as the foundation for most assessments. “New approach methods” draw on a range of novel alternative tests, strategies, and models. These methods 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.  

Although the promise of and need for new approach methods is clear, many barriers to their use remain. The new National Academies report calls on the 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. 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. 

Building Confidence in New Evidence Streams for Human Health Risk Assessment: Lessons Learned from Traditional Toxicity Tests is now available for immediate release. For inquiries, reporters can contact the Office of News and Public Information at tel. 202-334-2138 or email news@nas.edu