Big Question to Developing Solutions: A Decade of Progress in the Development of Aquatic New Approach Methodologies from 2012 to 2022

TY - JOUR

T1 - Big Question to Developing Solutions: A Decade of Progress in the Development of Aquatic New Approach Methodologies from 2012 to 2022

AU - Langan, Laura

AU - Paparella, Martin

AU - Burden, Natalie

AU - Constantine, Lisa

AU - Margiotta-Casaluci, Luigi

AU - Miller , Thomas H.

AU - Moe, S. Jannicke

AU - Owen, Stewart

AU - Schaffert , Alexandra

AU - Sikanen, Tiina

N1 - Funding Information: Research reported in this publication was supported by the National Institute of Environmental Health Sciences of the National Institutes of Health (1P01ES028942, to Laura M. Langan). Additional support was provided by Baylor University for Laura M. Langan. The work of Martin Paparella at the Medical University of Innsbruck is funded by the Austrian Federal Ministry for Climate Action, Environment, Energy, Mobility, Innovation and Technology, Department V/5—Chemicals Policy and Biocides. S. Jannicke Moe was supported by the Norwegian Institute for Water Research's Computational Toxicology Program. The work of Tiina Sikanen at the University of Helsinki was supported by the Academy of Finland (309608). We thank the two reviewers of the manuscript for their valuable feedback. Publisher Copyright: © 2023 The Authors. Environmental Toxicology and Chemistry published by Wiley Periodicals LLC on behalf of SETAC.

PY - 2023/2/1

Y1 - 2023/2/1

N2 - In 2012, 20 key questions related to hazard and exposure assessment and environmental and health risks of pharmaceuticals and personal care products in the natural environment were identified. A decade later, this article examines the current level of knowledge around one of the lowest-ranking questions at that time, number 19: “Can nonanimal testing methods be developed that will provide equivalent or better hazard data compared with current in vivo methods?” The inclusion of alternative methods that replace, reduce, or refine animal testing within the regulatory context of risk and hazard assessment of chemicals generally faces many hurdles, although this varies both by organism (human-centric vs. other), sector, and geographical region or country. Focusing on the past 10 years, only works that might reasonably be considered to contribute to advancements in the field of aquatic environmental risk assessment are highlighted. Particular attention is paid to methods of contemporary interest and importance, representing progress in (1) the development of methods which provide equivalent or better data compared with current in vivo methods such as bioaccumulation, (2) weight of evidence, or (3) -omic-based applications. Evolution and convergence of these risk assessment areas offer the basis for fundamental frameshifts in how data are collated and used for the protection of taxa across the breadth of the aquatic environment. Looking to the future, we are at a tipping point, with a need for a global and inclusive approach to establish consensus. Bringing together these methods (both new and old) for regulatory assessment and decision-making will require a concerted effort and orchestration. Environ Toxicol Chem 2023;00:1–15.

AB - In 2012, 20 key questions related to hazard and exposure assessment and environmental and health risks of pharmaceuticals and personal care products in the natural environment were identified. A decade later, this article examines the current level of knowledge around one of the lowest-ranking questions at that time, number 19: “Can nonanimal testing methods be developed that will provide equivalent or better hazard data compared with current in vivo methods?” The inclusion of alternative methods that replace, reduce, or refine animal testing within the regulatory context of risk and hazard assessment of chemicals generally faces many hurdles, although this varies both by organism (human-centric vs. other), sector, and geographical region or country. Focusing on the past 10 years, only works that might reasonably be considered to contribute to advancements in the field of aquatic environmental risk assessment are highlighted. Particular attention is paid to methods of contemporary interest and importance, representing progress in (1) the development of methods which provide equivalent or better data compared with current in vivo methods such as bioaccumulation, (2) weight of evidence, or (3) -omic-based applications. Evolution and convergence of these risk assessment areas offer the basis for fundamental frameshifts in how data are collated and used for the protection of taxa across the breadth of the aquatic environment. Looking to the future, we are at a tipping point, with a need for a global and inclusive approach to establish consensus. Bringing together these methods (both new and old) for regulatory assessment and decision-making will require a concerted effort and orchestration. Environ Toxicol Chem 2023;00:1–15.

UR - http://www.scopus.com/inward/record.url?scp=85150806101&partnerID=8YFLogxK

U2 - 10.1002/etc.5578

DO - 10.1002/etc.5578

M3 - Article

SN - 0730-7268

JO - ENVIRONMENTAL TOXICOLOGY AND CHEMISTRY

JF - ENVIRONMENTAL TOXICOLOGY AND CHEMISTRY

ER -