Ways to broaden the awareness, consideration and adoption of new approach methodologies (NAMs)
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Abstract
New approach methodologies (NAMs) refer to any technology, methodology, or combination thereof used to inform on chemical hazard and risk, and support replacement, reduction, or refinement of animal use. While the development and application of NAMs has recently increased, their adoption in regulatory decisions is slow and awareness outside the community is low. The Consideration of Alternative Methods Working Group (CAMWG) within the Interagency Coordinating Committee on the Validation of Alternative Methods focused on understanding how NAMs are considered by stakeholders and identifying ways to encourage adoption. A set of questions was developed to focus stakeholder discussions; CAMWG members met with stakeholder representatives to collect perspectives on how alternatives to traditional animal tests are considered when developing toxicology testing and research programs. Participants represented agrochemical, industrial chemical, consumer products, and pharmaceutical companies; academic researchers in toxicology; and Institutional Animal Care and Use Committees. All stakeholders currently use or consider NAMs—some more than others. Challenges to broader NAM adoption were identified and five common themes emerged as potential barriers: perception, regulatory acceptance, scientific and technical limitations, education, and financial considerations. Solutions to overcoming barriers were identified, such as tailored education, proactive collaboration and improved communication. Additional recommendations were ensuring fit-for-purpose use of NAMs, developing harmonized national and global acceptance criteria, identifying funding sources, increasing awareness about NAMs strengths and limitations, and a need for a more central repository for NAMs information. Here, we detail these discussions about NAMs use, barriers, and proposed solutions, to successfully expand awareness, consideration, and adoption.
Plain language summary
New approach methodologies (NAMs) are methods that can be used as alternatives to traditional animal testing. There’s been tremendous focus on development of NAMs, but adoption by regulatory bodies is often slow and awareness of NAMs by stakeholders outside of the community is low. The Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) promotes NAMs and replacement, reduction, or refinement of animal approaches. Within ICCVAM, the Consideration of Alternative Methods Working Group (CAMWG) aims to identify barriers and solutions for academic, government, and private industry scientists to increase NAMs awareness, consideration and adoption. CAMWG asked questions concerning organizational views on NAMs, their use or consideration, and why they aren’t used more often. Responses fit into five categories: perception, regulations, scientific/technical, education, and financial consideration. Participants suggested solutions, like customized training, cross-sector collaborations, funding, honest communications about NAMs, and a need for a single source providing trustworthy NAMs information.
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Brandauer, K., Schweinitzer, S., Lorenz, A. et al. (2025). Advances of dual-organ and multi-organ systems for gut, lung, skin and liver models in absorption and metabolism studies. Lab Chip 25, 1384-1403. doi:10.1039/d4lc01011f
Choudhuri, S., Patton, G. W., Chanderbhan, R. F. et al. (2018). From classical toxicology to Tox21: Some critical conceptual and technological advances in the molecular understanding of the toxic response beginning from the last quarter of the 20th century. Toxicol Sci 161, 5-22. doi:10.1093/toxsci/kfx186
Clippinger, A. J., Raabe, H. A., Allen, D. G. et al. (2021). Human-relevant approaches to assess eye corrosion/irritation potential of agrochemical formulations. Cutan Ocul Toxicol 40, 145-167. doi:10.1080/15569527.2021.1910291
Dobreniecki, S., Mendez, E., Lowit, A. et al. (2022). Integration of toxicodynamic and toxicokinetic new approach methods into a weight-of-evidence analysis for pesticide developmental neurotoxicity assessment: A case-study with dl- and l-glufosinate. Regul Toxicol Pharmacol 131, 105167. doi:10.1016/j.yrtph.2022.105167
EPA (2023). Availability of new approach methodologies (NAMs) in the endocrine disruptor screening program (EDSP). EPA’s Office of Chemical Safety and Pollution Prevention. U.S. Environmental Protection Agency. Washington, D.C., https://www.regulations.gov/document/EPA-HQ-OPP-2021-0756-0002
Fanizza, F., Perottoni, S., Boeri, L. et al. (2025). A gut-brain axis on-a-chip platform for drug testing challenged with donepezil. Lab Chip 25, 1854-1874. doi:10.1039/d4lc00273c
Husain, A., Meenakshi, D. U., Ahmad, A. et al. (2023). A review on alternative methods to experimental animals in biological testing: Recent advancement and current strategies. J Pharm Bioallied Sci 15, 165-171. doi:10.4103/jpbs.jpbs_380_23
ICCVAM (2024). Validation, qualification, and regulatory acceptance of new approach methodologies. National Toxicology Program Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM), Research Triangle Park, NC., doi:10.22427/NICEATM-2
Karmaus, A. L., Bialk, H., Fitzpatrick, S. et al. (2020). State of the science on alternatives to animal testing and integration of testing strategies for food safety assessments: Workshop proceedings. Regul Toxicol Pharmacol 110, 104515. doi:10.1016/j.yrtph.2019.104515
Kim, J. I., Imaizumi, K., Jurjut, O. et al. (2025). Human assembloid model of the ascending neural sensory pathway. Nature doi:10.1038/s41586-025-08808-3
Kleinstreuer, N. C., Hoffmann, S., Alepee, N. et al. (2018). Non-animal methods to predict skin sensitization (ii): An assessment of defined approaches (*). Crit Rev Toxicol 48, 359-374. doi:10.1080/10408444.2018.1429386
Ly Pham, L., Watford, S., Pradeep, P. et al. (2020). Variability in in vivo studies: Defining the upper limit of performance for predictions of systemic effect levels. Comput Toxicol 15, 1-100126. doi:10.1016/j.comtox.2020.100126
Magurany, K. A., Chang, X., Clewell, R. et al. (2023). A pragmatic framework for the application of new approach methodologies in one health toxicological risk assessment. Toxicol Sci 192, 155-177. doi:10.1093/toxsci/kfad012
Michielon, E., Boninsegna, M., Waaijman, T. et al. (2024). Environmentally controlled microfluidic system enabling immune cell flow and activation in an endothelialised skin-on-chip. Adv Healthc Mater 13, e2400750. doi:10.1002/adhm.202400750
OECD (2005). Guidance Document on the Validation and International Acceptance of New or Updated Test Methods for Hazard Assessment, OECD Series on Testing and Assessment, No. 34, OECD Publishing, Paris, doi:10.1787/e1f1244b-en.
OECD (2015). Test No. 430: In Vitro Skin Corrosion: Transcutaneous Electrical Resistance Test Method (TER), OECD Guidelines for the Testing of Chemicals, Section 4, OECD Publishing, Paris, doi:10.1787/9789264242739-en.
OECD (2019). Test No. 431: In vitro skin corrosion: reconstructed human epidermis (RHE) test method, OECD Guidelines for the Testing of Chemicals, Section 4, OECD Publishing, Paris, doi:10.1787/9789264264618-en.
OECD (2023a). Guideline No. 497: Defined Approaches on Skin Sensitisation, OECD Guidelines for the Testing of Chemicals, Section 4, OECD Publishing, Paris, doi:10.1787/b92879a4-en.
OECD (2023b). Test No. 437: Bovine Corneal Opacity and Permeability Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage, OECD Guidelines for the Testing of Chemicals, Section 4, OECD Publishing, Paris, doi:10.1787/9789264203846-en.
OECD (2023c). Initial Recommendations on Evaluation of Data from the Developmental Neurotoxicity (DNT) In-Vitro Testing Battery, OECD Series on Testing and Assessment, No. 377, OECD Publishing, Paris, doi:10.1787/91964ef3-en.
OECD (2023d). Test No. 438: Isolated Chicken Eye Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage, OECD Guidelines for the Testing of Chemicals, Section 4, OECD Publishing, Paris, doi:10.1787/9789264203860-en..
Pizzo, F., Gadaleta, D. and Benfenati, E. (2022). In silico models for repeated-dose toxicity (RDT): Prediction of the no observed adverse effect level (NOAEL) and lowest observed adverse effect level (LOAEL) for drugs. Methods Mol Biol 2425, 241-258. doi:10.1007/978-1-0716-1960-5_11
Rusyn, I., Sakolish, C., Kato, Y. et al. (2022). Microphysiological systems evaluation: Experience of Tex-Val tissue chip testing consortium. Toxicol Sci 188, 143-152. doi:10.1093/toxsci/kfac061
Schmeisser, S., Miccoli, A., von Bergen, M. et al. (2023). New approach methodologies in human regulatory toxicology - not if, but how and when! Environ Int 178, 108082. doi:10.1016/j.envint.2023.108082
Sewell, F., Alexander-White, C., Brescia, S. et al. (2024). New approach methodologies (NAMs): Identifying and overcoming hurdles to accelerated adoption. Toxicol Res 13, tfae044. doi:10.1093/toxres/tfae044
Singh, A. V., Romeo, A., Scott, K. et al. (2021). Emerging technologies for in vitro inhalation toxicology. Adv Healthc Mater 10, e2100633. doi:10.1002/adhm.202100633
Stucki, A. O., Barton-Maclaren, T. S., Bhuller, Y. et al. (2022). Use of new approach methodologies (NAMs) to meet regulatory requirements for the assessment of industrial chemicals and pesticides for effects on human health. Front Toxicol 4, 964553. doi:10.3389/ftox.2022.964553
van der Zalm, A. J., Barroso, J., Browne, P. et al. (2022). A framework for establishing scientific confidence in new approach methodologies. Arch Toxicol 96, 2865-2879. doi:10.1007/s00204-022-03365-4