The United States Environmental Protection Agency (US EPA) has recently proposed changes to strengthen the transparency of its pivotal regulatory science policy and procedures. In this context, the US EPA aims to enhance the transparency of dose-response data and models, proposing to consider for the first time non-linear biphasic dose-response models. While the proposed changes have the potential to lead to markedly improved ecological risk assessment compared to past and current approaches, we believe there remain open issues for improving the quality of ecological risk assessment, such as the consideration of adaptive, dynamic and interactive effects. Improved risk assessment including adaptive and dynamic non-linear models (beyond classic threshold models) can enhance the quality of regulatory decisions and the protection of ecological health. We suggest that other countries consider adopting a similar scientific-regulatory posture with respect to dose-response modeling via the inclusion of non-linear biphasic models, that incorporate the dynamic potential of biological systems to adapt (i.e., enhancing positive biological endpoints) or maladapt to low levels of stressor agents.

Commentary: EPA's proposed expansion of dose-response analysis is a positive step towards improving its ecological risk assessment / Agathokleous, Evgenios; Anav, Alessandro; Araminiene, Valda; De Marco, Alessandra; Domingos, Marisa; Kitao, Mitsutoshi; Koike, Takayoshi; Manning, William J.; Paoletti, Elena; Saitanis, Costas J.; Sicard, Pierre; Vitale, Marcello; Wang, Wenjie; Calabrese, Edward J.. - In: ENVIRONMENTAL POLLUTION. - ISSN 0269-7491. - 246:(2019), pp. 566-570. [10.1016/j.envpol.2018.12.046]

Commentary: EPA's proposed expansion of dose-response analysis is a positive step towards improving its ecological risk assessment

Vitale, Marcello
Writing – Review & Editing
;
2019

Abstract

The United States Environmental Protection Agency (US EPA) has recently proposed changes to strengthen the transparency of its pivotal regulatory science policy and procedures. In this context, the US EPA aims to enhance the transparency of dose-response data and models, proposing to consider for the first time non-linear biphasic dose-response models. While the proposed changes have the potential to lead to markedly improved ecological risk assessment compared to past and current approaches, we believe there remain open issues for improving the quality of ecological risk assessment, such as the consideration of adaptive, dynamic and interactive effects. Improved risk assessment including adaptive and dynamic non-linear models (beyond classic threshold models) can enhance the quality of regulatory decisions and the protection of ecological health. We suggest that other countries consider adopting a similar scientific-regulatory posture with respect to dose-response modeling via the inclusion of non-linear biphasic models, that incorporate the dynamic potential of biological systems to adapt (i.e., enhancing positive biological endpoints) or maladapt to low levels of stressor agents.
2019
dose-response; hormesis; non-linear response; regulation; risk assessment; dose-response relationship; drug; ecology; humans; nonlinear dynamics; risk assessment; United States; United States environmental protection agency; government regulation; toxicology; pollution; health; toxicology and mutagenesis
01 Pubblicazione su rivista::01a Articolo in rivista
Commentary: EPA's proposed expansion of dose-response analysis is a positive step towards improving its ecological risk assessment / Agathokleous, Evgenios; Anav, Alessandro; Araminiene, Valda; De Marco, Alessandra; Domingos, Marisa; Kitao, Mitsutoshi; Koike, Takayoshi; Manning, William J.; Paoletti, Elena; Saitanis, Costas J.; Sicard, Pierre; Vitale, Marcello; Wang, Wenjie; Calabrese, Edward J.. - In: ENVIRONMENTAL POLLUTION. - ISSN 0269-7491. - 246:(2019), pp. 566-570. [10.1016/j.envpol.2018.12.046]
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11573/1260311
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