On February 1, 2020, a multistakeholder group of civil society, academic, regulatory, and industry scientists published an article in the peer-reviewed journal Regulatory Toxicology and Pharmacology that presents a framework to evaluate new approach methodologies (NAMs) for the safety assessment of chemicals. Following earlier reports from the US National Research Council advocating “science-informed decision-making” for human health risk assessment, the authors note that there has since been “an explosion of initiatives by numerous organizations” in response, but that “these have been carried out independently and are not coordinated in any meaningful way.” To help address this, the study presents a set of criteria developed by the authors to evaluate if a NAM is “fit-for-purpose” within three steps. The framework aims “to support greater consistency across existing and future initiatives by providing a structure to collect relevant information to build confidence that will accelerate, facilitate and encourage development of new NAMs that can ultimately be used within the appropriate regulatory contexts.”
The framework involves first identifying the context of use for the NAM, which can be either prioritization of chemicals, hazard screening, or risk assessment. It then addresses a set of core principles including accuracy, transparency, understanding limitations, and the domain of applicability. A third step reviews a set of 12 criteria to evaluate whether a method is fit-for-purpose, including the quality of verification data sets, independent peer review, and explanation of the mechanistic basis for endpoints or pathways. The study concludes by illustrating the application of the framework to four different case studies.
Chemical Watch (February 27, 2020). “Academic and industry experts build evaluation framework for NAMs.”
Parish T. et al. (April 2020). “An evaluation framework for new approach methodologies (NAMs) for human health safety assessment.” Regulatory Toxicology and Pharmacology 112(104592)