Assessing the relevance of ecotoxicological studies for regulatory decision making

Abstract

Regulatory policies in many parts of the world recognize either the utility of or the mandate that all available studies be considered in environmental or ecological hazard and risk assessment (ERA) of chemicals, including studies from the peer-reviewed literature. Consequently, a vast array of different studies and data types need to be considered. The first steps in the evaluation process involve determining whether the study is relevant to the ERA and sufficiently reliable. Relevance evaluation is typically performed using existing guidance but involves application of "expert judgment" by risk assessors. In the present paper, we review published guidance for relevance evaluation and, on the basis of the practical experience within the group of authors, we identify additional aspects and further develop already proposed aspects that should be considered when conducting a relevance assessment for ecotoxicological studies. From a regulatory point of view, the overarching key aspect of relevance concerns the ability to directly or indirectly use the study in ERA with the purpose of addressing specific protection goals and ultimately regulatory decision making. Because ERA schemes are based on the appropriate linking of exposure and effect estimates, important features of ecotoxicological studies relate to exposure relevance and biological relevance. Exposure relevance addresses the representativeness of the test substance, environmental exposure media, and exposure regime. Biological relevance deals with the environmental significance of the test organism and the endpoints selected, the ecological realism of the test conditions simulated in the study, as well as a mechanistic link of treatment-related effects for endpoints to the protection goal identified in the ERA. In addition, uncertainties associated with relevance should be considered in the assessment. A systematic and transparent assessment of relevance is needed for regulatory decision making. The relevance aspects also need to be considered by scientists when designing, performing, and reporting ecotoxicological studies to facilitate their use in ERA. Integr Environ Assess Manag 2017;13:652-663. © 2016 The Authors. Integrated Environmental Assessment and Management published by Wiley Periodicals, Inc. on behalf of Society of Environmental Toxicology & Chemistry (SETAC).

Revising Environmental Quality Standards: Lessons Learned

“…While the results of standardized tests generally meet the requirements for reliability and relevance, they can only provide data on a limited number of model species and endpoints (Rudén et al 2017). Unfortunately, the assessment of data for relevance and reliability that is required for data used for EQS derivation led to the exclusion of numerous studies.…”

Assessing the reliability of ecotoxicological studies: An overview of current needs and approaches

“…This requires consideration of how well a study was conducted (i.e., reliability) and how relevant the observations are to the question (i.e., relevance). The former is discussed in this study and the latter in a companion paper (Ruden et al this issue). When used in hazard and/or risk assessment, reliability and relevance are often assessed separately, but for the final assessment they must be considered together, because they are mutually inclusive (Figure ).…”

Explanatory note on literature searching conducted in the context of GMO applications for (renewed) market authorisation and annual post‐market environmental monitoring reports on GMOs authorised in the EU market

“…Relevance considers the extent to which the study is appropriate for a particular hazard identification or risk characterisation, and thus the risk hypotheses addressed in the context of the GMO application under consideration (Rudén et al, 2017). Relevance considers the extent to which the study is appropriate for a particular hazard identification or risk characterisation, and thus the risk hypotheses addressed in the context of the GMO application under consideration (Rudén et al, 2017).…”