Washington Update

National Academies Committee on New Approach Methods Holds Inaugural Meeting

By: Naomi Charalambakis
Thursday, September 30, 2021

On September 23, the National Academies of Sciences, Engineering, and Medicine (NASEM) Committee on New Approach Methods (NAMs) in Human Health Risk Assessment convened for the first time to review the committee charge and statement of task. Sponsored by the U.S. Environmental Protection Agency (EPA), the NASEM committee is tasked with providing the EPA a review of the variability and relevance of existing laboratory mammalian toxicity tests for human health risk assessment. Additionally, the committee will develop data-driven expectations for utilizing NAMs—nonanimal research methods such as in-vitro and in-silico models—in federally funded toxicity research.

The committee’s establishment reflects EPA’s recent efforts to develop and incorporate nonanimal techniques in toxicity research and testing. The majority of these efforts originate from the September 2019 agency-wide directive to prioritize the reduction of mammalian testing by 2035. While the EPA’s current chemical risk assessment paradigm requires mammalian in-vivo laboratory testing to ensure human safety and efficacy, the variability of these methods and their concordance with human biology remains uncharacterized. To address this gap, the committee is charged with performing a comprehensive literature review of existing mammalian testing strategies and determining how this information can inform the development of scientific quality benchmarks for NAMs.

During the Q&A portion of the meeting, EPA representatives emphasized that the committee’s consideration for NAMs should remain focused on toxicity testing contexts rather than basic science research. Additionally, EPA officials underscored the need to ensure NAM end-points are of equivalent or better scientific quality than traditional animal models.

Before deliberations begin, the committee plans to convene a public workshop to field input from public stakeholders in the coming months. Members of the public can submit feedback regarding the committee’s progress using the designated NASEM portal. To view the prerecorded video distributed to committee members for the inaugural meeting, visit the “Meeting 1” NASEM website.