Exploring experiences of the regulatory toxicology system: system-level promoters and inhibitors of new approach methodologies

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.

Authors

Institutions

Publication Details

Journal
Archives of Toxicology
Published
2025-09-09
DOI
https://doi.org/10.1007/s00204-025-04168-z
Primary Topic
Animal testing and alternatives
Type
article
Field-Weighted Citation Impact
0.00

Funders

Controls
|||
ALL TIME
JAN
FEB
MAR
APR
MAY
JUN
JUL
AUG
SEP
OCT
article

Exploring experiences of the regulatory toxicology system: system-level promoters and inhibitors of new approach methodologies

Trine Husøy, Heather Ames, Miles P. Davenport, Arianna Giusti et al.
Archives of Toxicology
Animal testing and alternatives
article

Exploring experiences of the regulatory toxicology system: system-level promoters and inhibitors of new approach methodologies

Trine Husøy, Heather Ames, Miles P. Davenport, Arianna Giusti, Gunn Elisabeth Vist, Gro Haarklou Mathisen, Andrew A. Rooney, Fred A. Wright, Paul Whaley, Lowenna B Jones, Camilla Svendsen, Aleksandra Čavoški, Gisle Solstad, Seok Kwon, Denise Bloch, Sebastian Hoffmann, Jennifer Sass, Weihsueh A. Chiu, Angela Bearth, Birgit Kopainsky, Thomas Härtung, Holly Davies, Olivia J. Osborne, Christophe Rousselle
article en

Abstract

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.

Archives of ToxicologyVol. 99(12)
Washington State Department of Health (US), Natural Resources Defense Council (US), Norwegian Institute of Public Health (NO), North Carolina State University (US), Johns Hopkins University (US), National University of Singapore (SG), University of Konstanz (DE), Federal Institute for Risk Assessment (DE), UNSW Sydney (AU), Triangle (US), National Institute of Environmental Health Sciences (US), Cosmetics Europe (BE), Agence Nationale de Sécurité Sanitaire de l’Alimentation, de l’Environnement et du Travail (FR), University of Bergen (NO), HealthPartners (US), Lancaster University (GB), University of Birmingham (GB), Food Standards Agency (GB), Texas A&M University (US), University of Sheffield (GB)
U.S. Environmental Protection Agency, California Environmental Protection Agency, National Institute of Environmental Health Sciences
Openalex Percentile: Top 74%
Animal testing and alternatives
DOIOpen Access PDFOpenAlex
AI Navigator

Ask Laika to Summarize, Analyze, and Connect papers live on the map.

Summarize Papers & Methodologies

Extract key findings, datasets, and comparative methods across publications.

Benchmark Rankings & Visual Analytics

Rank top research institutions, authors, funders, topics, and journals by Field-Weighted Citation Impact (FWCI) and paper volume with instant charts.

Connect Distant Disciplines

Bridge topological clusters on the map to find hidden collaborative intersections.