Time for CHANGE : System-level interventions for bringing forward the date of effective use of NAMs in regulatory toxicology

Mathisen, Gro H and Bearth, Angela and Jones, Lowenna B and Hoffmann, Sebastian and Vist, Gunn E and Ames, Heather M and Husøy, Trine and Svendsen, Camilla and Tsaioun, Katya and Ashikaga, Takao and Bloch, Denise and Cavoski, Aleksandra and Chiu, Weihsueh A and Davies, Holly G and Giusti, Arianna and Hartung, Thomas and Hirabayashi, Yoko and Hogberg, Helena T and Joglekar, Rashmi and Kojima, Hajime and Krishnan, Kannan and Kwon, Seok and Osborne, Olivia J and Roggen, Erwin and Rooney, Andrew A and Rousselle, Christophe and Sass, Jennifer B and Sepai, Ovnair and Simanainen, Ulla and Thayer, Kristina A and Tong, Weida and Wikoff, Daniele and Wright, Fred and Whaley, Paul (2024) Time for CHANGE : System-level interventions for bringing forward the date of effective use of NAMs in regulatory toxicology. Archives of Toxicology, 98 (8). pp. 2299-2308. ISSN 0340-5761

Abstract

There has been considerable work over the past 20 years designed to bring about a paradigm shift in regulatory toxicology from chemical risk management decisions based on data from animal studies to a “Next Generation Risk Assessments” (NGRAs) system founded on New Approach Methods (NAMs). The perceived potential benefits of NAMs that are driving the paradigm shift include better protection of humans and the environment, the reduction of animal testing, and ultimately, a faster and more cost-effective test systems for evaluating chemical safety. In this article, we introduce the “Collaboration to Harmonise the Assessment of Next Generation Evidence” (CHANGE) project, a new initiative that seeks to design system-level interventions for bringing forward the date of effective use of NAMs, explaining its goals, approach, project management, governance, and funding.