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Policy Forum
Chemical Regulation

Policy reforms to update chemical safety testing

Science10 Mar 2017Vol 355, Issue 6329pp. 1016-1018DOI: 10.1126/science.aak9919

Abstract

Toxicological evaluation of chemicals and newly emerging substances, such as engineered nanomaterials, is essential to protect human health and the environment (1). Traditional approaches for chemical safety assessment often use high-dose animal studies, human exposure estimates, linear dose extrapolations, and uncertainty factors to determine the circumstances under which human exposure is safe. But in 2016, major bipartisan reform of the antiquated Toxic Substances Control Act (TSCA) in the United States embraced a new paradigm emerging across the globe (2). This paradigm, relying largely on nonanimal, alternative testing strategies (ATS), uses mechanism-based in vitro assays and in silico predictive tools for testing chemicals at considerably less cost (3). We provide a cautious but hopeful assessment of this intersection of law and science. Although the law generally takes a sensible approach to using ATS for regulatory purposes, commitment by the U.S. Environmental Protection Agency (EPA) and its partner agencies remains the key to successful integration of ATS in TSCA.
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References

1
A. E. Nel, et al., Science 311, 622 (2006).
2
Frank R. Lautenberg Chemical Safety for the 21st Century Act, H.R. 2576, 114th Cong., 2nd Sess. 2016,
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A. E. Nel, et al., ACS Nano 7, 6422 (2013).
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NRC, Toxicity Testing in the 21st Century: A Vision and a Strategy (National Academies Press, Washington, DC, 2007).
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Science
Volume 355 | Issue 6329
10 March 2017

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Published in print: 10 March 2017

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Andre E. Nel
Division of NanoMedicine, Department of Medicine, David Geffen School of Medicine, University of California, Los Angeles, CA 90095, USA.
California NanoSystems Institute, University of California, Los Angeles, CA 90095, USA.
Timothy F. Malloy
California NanoSystems Institute, University of California, Los Angeles, CA 90095, USA.
UCLA School of Law, University of California, Los Angeles, CA 90095, USA.
UCLA Center on Environmental and Occupational Health, University of California, Los Angeles, CA 90095, USA.

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  3. Prediction of Chronic Inflammation for Inhaled Particles: the Impact of Material Cycling and Quarantining in the Lung Epithelium, Advanced Materials, 32, 47, (2003913), (2020).https://doi.org/10.1002/adma.202003913
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  4. Toward Rigorous Materials Production: New Approach Methodologies Have Extensive Potential to Improve Current Safety Assessment Practices, Small, 16, 6, (1904749), (2020).https://doi.org/10.1002/smll.201904749
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  5. For (nano) rules and regulations: the learning curve, Nanomedicine, 15, 23, (2225-2228), (2020).https://doi.org/10.2217/nnm-2020-0219
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  8. The Right Stuff: On the Future of Nanotoxicology, Frontiers in Toxicology, 1, (2019).https://doi.org/10.3389/ftox.2019.00001
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  9. Advanced tools for the safety assessment of nanomaterials, Nature Nanotechnology, 13, 7, (537-543), (2018).https://doi.org/10.1038/s41565-018-0185-0
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  10. The NSF-EPA Centers for the Environmental Implications of Nanotechnology, Nanotechnology Environmental Health and Safety, (151-168), (2018).https://doi.org/10.1016/B978-0-12-813588-4.00007-5
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