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

Abstract

USA. The main workshop objectives were to improve the reliability and reproducibility of ecotoxicity studies, improve the use of peer-reviewed studies in regulatory risk assessment of chemicals, and improve the methods used in risk assessments when evaluating single or multiple lines of evidence. ABSTRACTIn general, reliable studies are well designed and well performed, and enough details on study design and performance are reported to assess the study. For hazard and risk assessment in various legal frameworks, many different types of ecotoxicity studies need to be evaluated for reliability. These studies vary in study design, methodology, quality, and level of detail reported (e.g., reviews, peer-reviewed research papers, or industry-sponsored studies documented under Good Laboratory Practice [GLP] guidelines). Regulators have the responsibility to make sound and verifiable decisions and should evaluate each study for reliability in accordance with scientific principles regardless of whether they were conducted in accordance with GLP and/or standardized methods. Thus, a systematic and transparent approach is needed to evaluate studies for reliability. In this paper, 8 different methods for reliability assessment were compared using a number of attributes: categorical versus numerical scoring methods, use of exclusion and critical criteria, weighting of criteria, whether methods are tested with case studies, domain of applicability, bias toward GLP studies, incorporation of standard guidelines in the evaluation method, number of criteria used, type of criteria considered, and availability of guidance material. Finally, some considerations are given on how to choose a suitable method for assessing reliability of ecotoxicity studies. Integr Environ Assess Manag 2017;13:640-651. C

Towards Sustainable Environmental Quality: Priority Research Questions for the Australasian Region of Oceania

“…However, it remains important to ensure the quality of data produced from standardized model systems, while advancing innovative and exploratory ecotoxicological research that may not be intended or amenable to directly be integrated within environmental assessments (Moermond et al 2017). However, it remains important to ensure the quality of data produced from standardized model systems, while advancing innovative and exploratory ecotoxicological research that may not be intended or amenable to directly be integrated within environmental assessments (Moermond et al 2017).…”

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

“…For the purposes of this explanatory note, the fact that a study reported in a study may not be conducted in accordance with Good Laboratory Practice (GLP) does not imply that the study is irrelevant (Moermond et al, 2016). For the purposes of this explanatory note, the fact that a study reported in a study may not be conducted in accordance with Good Laboratory Practice (GLP) does not imply that the study is irrelevant (Moermond et al, 2016).…”

“…Relevant studies should be appraised in terms of their reliability (EFSA, 2015a; Moermond et al, 2016). Reliability refers to the extent to which a study is free from bias and its findings reflect true facts.…”

What training and skills will the ecotoxicologists of the future require?

“…However, if every academic researcher had a fundamental knowledge of the regulatory context of their research, there is much that could be done to increase the regulatory relevance of their data, often in small but significant ways. Considerations such as choice of test organism, organism life stage, exposure concentration and duration, and other test conditions can dramatically alter the usability of these studies for regulatory review (Ågerstrand et al ; Moermond et al this issue; Rudén et al this issue). For example, data generated with a tropical species may not be suitable for a risk assessment for a temperate region.…”