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A. Stucki, Tara S. Barton‐Maclaren, Yadvinder Bhuller, Joseph E. Henriquez, Tala R. Henry, Carole Hirn, Jacqueline Miller‐Holt, Edith G. Nagy, Monique M. Perron, Deborah E. Ratzlaff, Todd J. Stedeford, Amy J. Clippinger
New approach methodologies (NAMs) are increasingly being used for regulatory decision making by agencies worldwide because of their potential to reliably and efficiently produce information that is fit for purpose while reducing animal use. This article summarizes the ability to use NAMs for the assessment of human health effects of industrial chemicals and pesticides within the United States, Canada, and European Union regulatory frameworks. While all regulations include some flexibility to allow for the use of NAMs, the implementation of this flexibility varies across product type and regulatory scheme. This article provides an overview of various agencies' guidelines and strategic plans on the use of NAMs, and specific examples of the successful application of NAMs to meet regulatory requirements. It also summarizes intra- and inter-agency collaborations that strengthen scientific, regulatory, and public confidence in NAMs, thereby fostering their global use as reliable and relevant tools for toxicological evaluations. Ultimately, understanding the current regulatory landscape helps inform the scientific community on the steps needed to further advance timely uptake of approaches that best protect human health and the environment.
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Stucki, A., Barton‐Maclaren, T. S., Bhuller, Y., Henriquez, J. E., Henry, T. R., Hirn, C., Miller‐Holt, J., Nagy, E. G., Perron, M. M., Ratzlaff, D. E., Stedeford, T. J., & Clippinger, A. J. (2022). Use of new approach methodologies (NAMs) to meet regulatory requirements for the assessment of industrial chemicals and pesticides for effects on human health. Frontiers in Toxicology, 4, 964553. https://doi.org/10.3389/ftox.2022.964553
Stucki, A., et al. "Use of new approach methodologies (NAMs) to meet regulatory requirements for the assessment of industrial chemicals and pesticides for effects on human health." Frontiers in Toxicology, vol. 4, 2022, pp. 964553, https://doi.org/10.3389/ftox.2022.964553.
Stucki, A., Tara S. Barton‐Maclaren, Yadvinder Bhuller, Joseph E. Henriquez, Tala R. Henry, Carole Hirn, Jacqueline Miller‐Holt, et al. "Use of new approach methodologies (NAMs) to meet regulatory requirements for the assessment of industrial chemicals and pesticides for effects on human health." Frontiers in Toxicology 4 (2022): 964553. https://doi.org/10.3389/ftox.2022.964553.
Stucki A., Barton‐Maclaren T. S., Bhuller Y. [и др.] Use of new approach methodologies (NAMs) to meet regulatory requirements for the assessment of industrial chemicals and pesticides for effects on human health // Frontiers in Toxicology. — 2022. — Vol. 4. — P. 964553. — URL: https://doi.org/10.3389/ftox.2022.964553
@article{stucki2022approach,
title = {{Use of new approach methodologies (NAMs) to meet regulatory requirements for the assessment of industrial chemicals and pesticides for effects on human health}},
author = {A. Stucki and Tara S. Barton‐Maclaren and Yadvinder Bhuller and Joseph E. Henriquez and Tala R. Henry and Carole Hirn and Jacqueline Miller‐Holt and Edith G. Nagy and Monique M. Perron and Deborah E. Ratzlaff and Todd J. Stedeford and Amy J. Clippinger},
journal = {Frontiers in Toxicology},
year = {2022},
volume = {4},
pages = {964553},
doi = {10.3389/ftox.2022.964553},
url = {https://doi.org/10.3389/ftox.2022.964553}
}TY - JOUR AU - Stucki, A. AU - Barton‐Maclaren, Tara S. AU - Bhuller, Yadvinder AU - Henriquez, Joseph E. AU - Henry, Tala R. AU - Hirn, Carole AU - Miller‐Holt, Jacqueline AU - Nagy, Edith G. AU - Perron, Monique M. AU - Ratzlaff, Deborah E. AU - Stedeford, Todd J. AU - Clippinger, Amy J. TI - Use of new approach methodologies (NAMs) to meet regulatory requirements for the assessment of industrial chemicals and pesticides for effects on human health JO - Frontiers in Toxicology VL - 4 SP - 964553 PY - 2022 DA - 2022/09/01 DO - 10.3389/ftox.2022.964553 UR - https://doi.org/10.3389/ftox.2022.964553 ER -
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