TY - JOUR
KW - chemical risk assessment
KW - new approach methodologies
KW - Next generation risk assessment
KW - Systems thinking
AU - Angela Bearth
AU - Birgit Kopainsky
AU - Lowenna B. Jones
AU - Gunn E. Vist
AU - Trine Husøy
AU - Camilla Svendsen
AU - Paul Whaley
AU - Sebastian Hoffmann
AU - Heather M. Ames
AU - Gisle Solstad
AU - Denise Bloch
AU - Aleksandra Čavoški
AU - Weihsueh A. Chiu
AU - Miles Davenport
AU - Holly G. Davies
AU - Arianna Giusti
AU - Thomas Hartung
AU - Seok Kwon
AU - Olivia J. Osborne
AU - Andrew A. Rooney
AU - Christophe Rousselle
AU - Jennifer B. Sass
AU - Fred A. Wright
AU - Gro H. Mathisen
AB - The transition from traditional animal-based approaches and assessments to New Approach Methodologies (NAMs) marks a scientific revolution in regulatory toxicology, with the potential of enhancing human and environmental protection. However, implementing the effective use of NAMs in regulatory toxicology has proven to be challenging, and so far, efforts to facilitate this change frequently focus on singular technical, psychological or economic inhibitors. This article takes a system-thinking approach to these challenges, a holistic framework for describing interactive relationships between the components of a system of interest. In this case, the regulatory toxicology system. We do so by analysing and interpreting a very large qualitative data set of experts’ observations, collected in a 3-day interactive workshop and three follow-up online workshops with a heterogeneous sample of experts representing major actors from the global regulatory toxicology system. We identified leverage points (where a small change within a system can have a disproportionately large effect) in the six core aspects—infrastructure, processes, culture, technology, goals, and actors—in the regulatory toxicology system to facilitate the effective use of NAMs. Identified systematic leverage points include the need for a functioning incentive structure for effectively discovering, developing, validating and using NAMs within academia, regulation, and industry; and measures that prevent or mitigate unwanted effects of using NAMs that acknowledge clashes between scientific, regulatory, political and social processes. The results serve as a basis for follow-up activities that reflect on the actual effectiveness of these levers and that develop measures for the regulatory toxicology system.
BT - Archives of Toxicology
DA - 2025-12-01
DO - 10.1007/s00204-025-04168-z
IS - 12
LA - en
N2 - The transition from traditional animal-based approaches and assessments to New Approach Methodologies (NAMs) marks a scientific revolution in regulatory toxicology, with the potential of enhancing human and environmental protection. However, implementing the effective use of NAMs in regulatory toxicology has proven to be challenging, and so far, efforts to facilitate this change frequently focus on singular technical, psychological or economic inhibitors. This article takes a system-thinking approach to these challenges, a holistic framework for describing interactive relationships between the components of a system of interest. In this case, the regulatory toxicology system. We do so by analysing and interpreting a very large qualitative data set of experts’ observations, collected in a 3-day interactive workshop and three follow-up online workshops with a heterogeneous sample of experts representing major actors from the global regulatory toxicology system. We identified leverage points (where a small change within a system can have a disproportionately large effect) in the six core aspects—infrastructure, processes, culture, technology, goals, and actors—in the regulatory toxicology system to facilitate the effective use of NAMs. Identified systematic leverage points include the need for a functioning incentive structure for effectively discovering, developing, validating and using NAMs within academia, regulation, and industry; and measures that prevent or mitigate unwanted effects of using NAMs that acknowledge clashes between scientific, regulatory, political and social processes. The results serve as a basis for follow-up activities that reflect on the actual effectiveness of these levers and that develop measures for the regulatory toxicology system.
PY - 2025
SP - 4909
EP - 4930
ST - Exploring experiences of the regulatory toxicology system
T2 - Archives of Toxicology
TI - Exploring experiences of the regulatory toxicology system: system-level promoters and inhibitors of new approach methodologies
UR - https://doi.org/10.1007/s00204-025-04168-z
VL - 99
Y2 - 2026-07-29
SN - 1432-0738
ER -