Use of new approach methodologies (NAMs) to meet regulatory requirements for the assessment of industrial chemicals and pesticides for effects on human health

Abstract

New approach methodologies (NAMs) are increasingly being used for regulatory decision making by agencies worldwide because of their potential to reliably and efficiently produce information that is fit for purpose while reducing animal use. This article summarizes the ability to use NAMs for the assessment of human health effects of industrial chemicals and pesticides within the United States, Canada, and European Union regulatory frameworks. While all regulations include some flexibility to allow for the use of NAMs, the implementation of this flexibility varies across product type and regulatory scheme. This article provides an overview of various agencies’ guidelines and strategic plans on the use of NAMs, and specific examples of the successful application of NAMs to meet regulatory requirements. It also summarizes intra- and inter-agency collaborations that strengthen scientific, regulatory, and public confidence in NAMs, thereby fostering their global use as reliable and relevant tools for toxicological evaluations. Ultimately, understanding the current regulatory landscape helps inform the scientific community on the steps needed to further advance timely uptake of approaches that best protect human health and the environment.

A Transformative Vision for an Omics-Based Regulatory Chemical Testing Paradigm

“…While dissimilar from the current toxicity testing practices of characterizing various apical outcomes, this paradigm is expected to be equivalent in the level of human health protection. This vision serves as a starting point which could be adapted and built upon to meet different regulatory and programmatic needs ( Stucki et al , 2022 ).…”

Chemical and in vitro toxicological comparison of emissions from a heated tobacco product and the 1R6F reference cigarette

“…In the present study, we performed several in vitro toxicological assays which includes not only traditional genotoxicity and cytotoxicity assays but also non-standardized but mechanistic assays. New approach methodologies (NAMs), which include in silico , in chemico , in vitro , and ex vivo approaches [47] , [48] , are being rapidly developed because of, while not yet fully validated their potential to reliably reflect human biology [49] . Recently, the 3D bronchial epithelial model has been applied as mechanistic follow-up in vitro toxicity comparison among CS and THS2.2 [50] , THP1.0 [51] , [52] , or the other type of HTP [31] , [53] , [54] .…”

A call for a Human Exposome Project

“…This dilemma is especially obvious in the regulatory arena, where we often could change but do not manage to replace) principles and shifts resources to focus on generating more scientific mechanism-based carcinogenicity assessments, while continuing to promote safe and ethical development of new pharmaceuticals." Even in the pesticide sector, which relies heavily on animal testing of its products, progress is being made internationally toward the 3Rs (Stucki et al, 2022).…”