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

Gro H Mathisen¹, Angela Bearth^{2

3}, Lowenna B Jones^{2

4}, Sebastian Hoffmann^{5

6}, Gunn E Vist^{2

7}, Heather M Ames^{2

7}, Trine Husøy^{2

8}, Camilla Svendsen^{2

9}, Katya Tsaioun⁵, Takao Ashikaga¹⁰, Denise Bloch¹¹, Aleksandra Cavoski¹², Weihsueh A Chiu¹³, Holly G Davies¹⁴, Arianna Giusti¹⁵, Thomas Hartung^{16

17}, Yoko Hirabayashi¹⁸, Helena T Hogberg¹⁹, Rashmi Joglekar²⁰, Hajime Kojima^{21

22}, Kannan Krishnan²³, Seok Kwon²⁴, Olivia J Osborne²⁵, Erwin Roggen²⁶, Andrew A Rooney²⁷, Christophe Rousselle²⁸, Jennifer B Sass^{29

30}, Ovnair Sepai³¹, Ulla Simanainen³², Kristina A Thayer³³, Weida Tong³⁴, Daniele Wikoff³⁵, Fred Wright³⁶, Paul Whaley^{37

38}

Affiliations

¹ Norwegian Scientific Committee for Food and Environment, Norwegian Institute of Public Health, Oslo, Norway. gro.haarklou.mathisen@vkm.no.
² Norwegian Scientific Committee for Food and Environment, Norwegian Institute of Public Health, Oslo, Norway.
³ HF Partners, Tièchestrasse 63, 8037, Zurich, Switzerland.
⁴ Department of Politics and International Relations, University of Sheffield, Sheffield, UK.
⁵ Evidence-Based Toxicology Collaboration (EBTC), Johns Hopkins University, Bloomberg School of Public Health, Baltimore, MD, USA.
⁶ Seh Consulting + Services, Paderborn, Germany.
⁷ Division for Health Services, Norwegian Institute of Public Health, Oslo, Norway.
⁸ Department of Food Safety, Norwegian Institute of Public Health, Oslo, Norway.
⁹ Department of Chemical Toxicology, Norwegian Institute of Public Health, Oslo, Norway.
¹⁰ Division of Genome Safety Science/JaCVAM, Center for Biological Safety Research (CBSR), National Institute of Health Sciences (NIHS), Kawasaki, Japan.
¹¹ Department of Pesticides Safety, German Federal Institute for Risk Assessment (BfR), Berlin, Germany.
¹² Birmingham Law School, University of Birmingham, Birmingham, UK.
¹³ Department of Veterinary Physiology and Pharmacology, College of Veterinary Medicine and Biomedical Sciences, Texas A&M University, College Station, TX, USA.
¹⁴ Department of Health, Washington State, Tumwater, WA, USA.
¹⁵ Cosmetics Europe, Avenue Herrmann-Debroux 40, 1160, Auderghem, Belgium.
¹⁶ Center for Alternatives to Animal Testing (CAAT), Johns Hopkins University, Bloomberg School of Public Health, Baltimore, MD, USA.
¹⁷ CAAT Europe, University of Konstanz, Konstanz, Germany.
¹⁸ Center for Biological Safety Research (CBSR), National Institute of Health Sciences (NIHS), Kawasaki, Japan.
¹⁹ National Toxicology Program Interagency Center for the Evaluation of Alternative Toxicological Methods, Division of Translational Toxicology, National Institute of Environmental Health Sciences, Research Triangle Park, NC, USA.
²⁰ Department of Obstetrics, Gynecology and Reproductive Sciences, Program On Reproductive Health and the Environment, University of California, San Francisco, USA.
²¹ Division of Food Additives, National Institute of Health Sciences (NIHS), Kawasaki, Japan.
²² Faculty of Engineering, Sanyo-Onoda City University, Yamaguchi, Japan.
²³ Air and Site Assessment and Climate Indicators Branch, Division of Scientific Programs, Office of Environmental Health Hazard Assessment, 1001 I Street, Sacramento, CA, USA.
²⁴ Department of Pharmacology, Yong Loo Lin School of Medicine, National University of Singapore, Singapore, 119077, Singapore.
²⁵ Chemical Risk Assessment Team, Science, Evidence and Research Division, Food Standards Agency, Petty France, Westminster, London, SW1H 9EX, UK.
²⁶ 3Rs Management and Consulting ApS, Lyngby, Denmark.
²⁷ Division of Translational Toxicology, National Institute of Environmental Health Sciences, Research Triangle Park, NC, USA.
²⁸ French Agency for Food, Environmental and Occupational Health and Safety (ANSES), 94701, Maisons-Alfort, France.
²⁹ Natural Resources Defense Council, Washington, DC, USA.
³⁰ George Washington University, Washington, DC, USA.
³¹ UK Health Security Agency, London, SE1 8UG, UK.
³² European Chemicals Agency, Helsinki, Finland.
³³ Center for Public Health and Environmental Assessment, Chemical and Pollutant Assessment Division (CPAD), U.S. EPA, Durham, NC, USA.
³⁴ National Center for Toxicological Research of US Food and Drug Administration, Jefferson, AR, USA.
³⁵ ToxStrategies, Asheville, NC, USA.
³⁶ Departments of Statistics and Biological Sciences and Bioinformatics Research Center, North Carolina State University, Raleigh, NC, USA.
³⁷ Norwegian Scientific Committee for Food and Environment, Norwegian Institute of Public Health, Oslo, Norway. paul@whaleyresearch.uk.
³⁸ Lancaster Environment Centre, Lancaster University, Lancaster, UK. paul@whaleyresearch.uk.

PMID: 38877155
PMCID: PMC11784933
DOI: 10.1007/s00204-024-03802-6

Editorial

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

Gro H Mathisen et al. Arch Toxicol. 2024 Aug.

. 2024 Aug;98(8):2299-2308.

doi: 10.1007/s00204-024-03802-6. Epub 2024 Jun 14.

Authors

Affiliations

¹ Norwegian Scientific Committee for Food and Environment, Norwegian Institute of Public Health, Oslo, Norway. gro.haarklou.mathisen@vkm.no.
² Norwegian Scientific Committee for Food and Environment, Norwegian Institute of Public Health, Oslo, Norway.
³ HF Partners, Tièchestrasse 63, 8037, Zurich, Switzerland.
⁴ Department of Politics and International Relations, University of Sheffield, Sheffield, UK.
⁵ Evidence-Based Toxicology Collaboration (EBTC), Johns Hopkins University, Bloomberg School of Public Health, Baltimore, MD, USA.
⁶ Seh Consulting + Services, Paderborn, Germany.
⁷ Division for Health Services, Norwegian Institute of Public Health, Oslo, Norway.
⁸ Department of Food Safety, Norwegian Institute of Public Health, Oslo, Norway.
⁹ Department of Chemical Toxicology, Norwegian Institute of Public Health, Oslo, Norway.
¹⁰ Division of Genome Safety Science/JaCVAM, Center for Biological Safety Research (CBSR), National Institute of Health Sciences (NIHS), Kawasaki, Japan.
¹¹ Department of Pesticides Safety, German Federal Institute for Risk Assessment (BfR), Berlin, Germany.
¹² Birmingham Law School, University of Birmingham, Birmingham, UK.
¹³ Department of Veterinary Physiology and Pharmacology, College of Veterinary Medicine and Biomedical Sciences, Texas A&M University, College Station, TX, USA.
¹⁴ Department of Health, Washington State, Tumwater, WA, USA.
¹⁵ Cosmetics Europe, Avenue Herrmann-Debroux 40, 1160, Auderghem, Belgium.
¹⁶ Center for Alternatives to Animal Testing (CAAT), Johns Hopkins University, Bloomberg School of Public Health, Baltimore, MD, USA.
¹⁷ CAAT Europe, University of Konstanz, Konstanz, Germany.
¹⁸ Center for Biological Safety Research (CBSR), National Institute of Health Sciences (NIHS), Kawasaki, Japan.
¹⁹ National Toxicology Program Interagency Center for the Evaluation of Alternative Toxicological Methods, Division of Translational Toxicology, National Institute of Environmental Health Sciences, Research Triangle Park, NC, USA.
²⁰ Department of Obstetrics, Gynecology and Reproductive Sciences, Program On Reproductive Health and the Environment, University of California, San Francisco, USA.
²¹ Division of Food Additives, National Institute of Health Sciences (NIHS), Kawasaki, Japan.
²² Faculty of Engineering, Sanyo-Onoda City University, Yamaguchi, Japan.
²³ Air and Site Assessment and Climate Indicators Branch, Division of Scientific Programs, Office of Environmental Health Hazard Assessment, 1001 I Street, Sacramento, CA, USA.
²⁴ Department of Pharmacology, Yong Loo Lin School of Medicine, National University of Singapore, Singapore, 119077, Singapore.
²⁵ Chemical Risk Assessment Team, Science, Evidence and Research Division, Food Standards Agency, Petty France, Westminster, London, SW1H 9EX, UK.
²⁶ 3Rs Management and Consulting ApS, Lyngby, Denmark.
²⁷ Division of Translational Toxicology, National Institute of Environmental Health Sciences, Research Triangle Park, NC, USA.
²⁸ French Agency for Food, Environmental and Occupational Health and Safety (ANSES), 94701, Maisons-Alfort, France.
²⁹ Natural Resources Defense Council, Washington, DC, USA.
³⁰ George Washington University, Washington, DC, USA.
³¹ UK Health Security Agency, London, SE1 8UG, UK.
³² European Chemicals Agency, Helsinki, Finland.
³³ Center for Public Health and Environmental Assessment, Chemical and Pollutant Assessment Division (CPAD), U.S. EPA, Durham, NC, USA.
³⁴ National Center for Toxicological Research of US Food and Drug Administration, Jefferson, AR, USA.
³⁵ ToxStrategies, Asheville, NC, USA.
³⁶ Departments of Statistics and Biological Sciences and Bioinformatics Research Center, North Carolina State University, Raleigh, NC, USA.
³⁷ Norwegian Scientific Committee for Food and Environment, Norwegian Institute of Public Health, Oslo, Norway. paul@whaleyresearch.uk.
³⁸ Lancaster Environment Centre, Lancaster University, Lancaster, UK. paul@whaleyresearch.uk.

PMID: 38877155
PMCID: PMC11784933
DOI: 10.1007/s00204-024-03802-6

No abstract available

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Conflict of interest statement

Conflict of interest The authors declare that they have no conflict of interest. Jennifer B. Sass is on faculty at George Washington University and works for the Natural Resources Defense Council (NRDC), a public interest non-profit group. As a part of her work, she makes public statements on the science, policy, and regulatory actions, including litigation to enforce environmental laws, relevant to the subject matter of this manuscript. Several of the co-authors are currently working on one or more of the EU funded projects PrecisionTox, ONTOX, and PARC (Gro H. Mathisen, Angela Bearth, Gunn E. Vist, Heather M. Ames, Trine Husøy, Camilla Svendsen, Denise Bloch, Aleksandra Čavoški, Thomas Hartung, Erwin Roggen, Christophe Rousselle, Ovnair Sepai, and Paul Whaley).

Figures

**Fig. 1**
Illustration of the “iceberg” (Vecteezy.com) of the events and patterns that system participants can observe, from which they develop mental models of the underlying structures of the system [adapted from Kim (1999), Monat and Gannon (2023) and Mosaffa (2023)]. The models can be interrogated by investigators as part of a method for developing theories about how the system works and can be influenced

**Fig. 2**
The three phases of the CHANGE project

See this image and copyright information in PMC

References

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

Affiliations

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

Authors

Affiliations

Conflict of interest statement

Figures

References

Publication types

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Grants and funding

LinkOut - more resources

Full Text Sources