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

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What makes CHANGE a unique contribution to the challenge of NAM uptake are the following four key approaches being taken to the project, that we expand upon throughout this manuscript: 1/An emphasis on effective use of NAMs, whereby we do not view the use of NAMs as a goal in itself, rather that there should be an effective regulatory infrastructure enabling effective use of actionable evidence created by NAMs, reflecting the goals and values of the stakeholders that the infrastructure is intended to serve. 2/A longitudinal, iterated, and interdisciplinary methodology, whereby we seek to explore participants’ experience of the use of NAM data in relation to their goals and use this as data to identify and prioritise areas for possible intervention to promote effective use of NAMs. 3/A focus on “system factors”, i.e. modifiable elements of the supra-, inter- and intra-organisational structures within which NAM-based research is conducted, interpreted, and acted on, which we believe are under-researched and may provide new opportunities for interventions to bring forward the date of effective use of NAMs in regulatory toxicology. 4/An ambition of inclusivity and a global outlook, in which we are taking a purposefully cross-sector and international approach to project participation, aiming to cover not only those who create, analyse, and use NAM data (researchers, risk assessors, and risk managers respectively), but also those who are impacted by the decisions taken supported by NAM data (e.g. civil society, workers, communities and others that are impacted by regulatory decisions).

Impact/Purpose

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). Whilst all NAM definitions include in silico, in vitro, ex vivo and in chemico approaches (Schmeisser et al. 2023), some also cover in vivo reduction and refinement approaches (ICCVAM 2018; USEPA 2018). 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 (Dent et al. 2021; USEPA 2014). In this article, we introduce the “Collaboration to Harmonise the Assessment of Next Generation Evidence (https://vkm.no/english/change/collaborationtoharmonisetheassessmentofnextgenerationevidence.4.46e970eb18cbde223fe711f2.html)” (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. CHANGE is far from the first effort to shape the use of NAMs in regulatory toxicology, and we seek to build on or complement efforts by ECHA, EFSA, ICCVAM, NTP, PARC, US EPA, and many others (ECHA 2016, 2023; EFSA et al. 2022; ICCVAM 2018; NTP 2024; PARC 2023; PrecisionTox 2024; USEPA 2018), all of which seek to inform, progress, and advance use and adoption of NAMs.

Citation

Chialton, Kristina, G. Mathisen, V. Didier, A. Rooney, T. Hartung, D. Bloch, W. Chiu, U. SIMANAINEN, A. Cavoski, O. Sepai, E. Roggen, M. Davenport, C. Rousselle, F. Wright, A. Giusti, J. Sass, S. Fitzpatrick, H. Davies, W. Tong, O. Osborn, D. Wikoff, H. Hogberg, K. Krishnan, R. Joglekar, H. Kojima, T. Ashikaga, Y. Hirabayashi, S. Hoffmann, P. Whaley, G. Vist, H. Ames, T. Hus�y, A. Bearth, L. Jones, K. Tsaloun, G. Solstad, AND C. Svendsen. Time for CHANGE: system-level interventions for bringing forward the date of effective use of NAMs in regulatory toxicology. Springer, New York, NY, 98:2299-2308, (2024). [DOI: 10.1007/s00204-024-03802-6]

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  • https://link.springer.com/article/10.1007/s00204-024-03802-6
DOI: Time for CHANGE: system-level interventions for bringing forward the date of effective use of NAMs in regulatory toxicology
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Last updated on February 03, 2025
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