Perspectives on Relevancy Assessment for Non-Standard Ecotoxicity Data in Environment Quality Standard derivation: Examp

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PERSPECTIVE

Perspectives on Relevancy Assessment for Non‑Standard Ecotoxicity Data in Environment Quality Standard derivation: Examples for Diclofenac Graham Merrington1 · Dean Leverett1 · Adam Peters1 · Jim Ryan2 Received: 17 June 2020 / Accepted: 8 October 2020 © Springer Science+Business Media, LLC, part of Springer Nature 2020

Abstract A key step in deriving an Environmental Quality Standard (EQS) is assessing the reliability and relevance of the underpinning ecotoxicity data. While the assessment of data reliability is relatively well established, the detailed evaluation of data relevancy is a more recent development. We applied broadly accepted relevancy criteria to a series of non-standard ecotoxicity studies on diclofenac, focusing on some aspects that should be accounted for in studies used in EQS derivation. Specific relevancy issues include potential experimental bias, claimed ‘significant effects’ that are indistinguishable from controls, or within the range of normal, and lack of environmental applicability. We highlight that rigorous, comprehensive and, where necessary, specialist assessment of data relevancy for studies potentially applicable for EQS setting is critical if studies are to be appropriately used regulatory decision-making. We provide recommendations for researchers and environmental practitioners to ensure robust accounting of relevancy in non-standard studies is undertaken. Keywords  Diclofenac · Reliability · Relevance · Environmental quality standard · Water framework directive An aim of the European Water Framework Directive (WFD) (2000/60/EC) is to restore all waters to ‘good’ status. One of the tools used to meet this aim are Environmental Quality Standards (EQS) derived for chemicals that represent Europe-wide risks. These risks are assessed on the basis of a comparison of measured chemical exposures in surface waters against the EQS, which is derived from hazard data in order to be protective of aquatic ecosystems. Diclofenac, a nonsteroidal anti-inflammatory human medicine, has been widely detected in European surface waters, with the major source being wastewater treatment discharges (Carvalho et  al. 2016). Exposure of aquatic organisms to diclofenac in surface waters is likely, yet to quantify the form and magnitude of potential risk, hazard data need to be assessed and an environmentally relevant metric developed, such as an EQS. An EQS is derived using laboratory generated ecotoxicity data on aquatic organisms. * Graham Merrington graham.merrington@wca‑consulting.com 1



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In Europe, chronic ecotoxicity data are required for the derivation of an annual average EQS following the WFD EQS Technical Guidance (EC 2018). Draft EQS have been derived for diclofenac, but not yet been implemented on a Europe-wide basis (e.g. UBA 2018). Academic interest in pharmaceuticals in the aquatic environment over the last ten years has led to an incr