An Evaluation Framework for NAMs for Human Health Safety Assessment
Increased interest in using NAMs for safety assessment has resulted in an explosion of initiatives by numerous organizations. For the most part, these have been carried out independently and are not coordinated in any meaningful way. To help remedy this situation, a multistakeholder group of industry, academic, and regulatory experts including FDA and NIEHS scientists developed a framework that presents a consistent set of criteria, universal across initiatives, to evaluate a NAM's fit-for-purpose (Parish et al. 2020). This framework will provide a structure to collect relevant, confidence-building information that will accelerate, facilitate, and encourage development of new NAMs for use within the appropriate regulatory contexts. In addition, this framework provides a systematic approach to evaluate currently available NAMs and determine their suitability for potential regulatory application. This three-step evaluation framework, along with the demonstrated application with case studies, will help build confidence in the scientific understanding of these methods and their value for chemical assessment and regulatory decision-making.