Relevance and Quality of Ecotoxicological Data: Why is this Important in Risk Assessment? Why Use a Consistent Evaluation Approach?

Posted: June 26, 2019 News

For a risk assessment to be credible and objective, scientifically defensible data must be used. This means that the studies used to generate the data must be evaluated using a standardized evaluation method, regardless of whether the studies were conducted in accordance with Good Laboratory Practice (GLP). It is, therefore, essential to apply transparent and consistent evaluation criteria to all ecotoxicity studies. This approach will assure that “best available data” are used in risk assessments. It will further ensure consistency and reproducibility of the evaluations, which are key factors in public acceptance (Bevan and Strother 2012; Ågerstrand et al. 2014; Moermond et al. 2016; Martin et al. 2019).

Study evaluation schemes are based on relevance and data quality. Because ecological risk assessment methods link exposure and effect estimates, exposure relevance and biological relevance need to be considered in the evaluation. Data quality relates to the experimental design, how well the experimental procedures were performed, and the reporting of the results. Ultimately, reproduction of results using the same procedures should be achievable. Study criteria are designed to characterize the relevance and quality of the studies.

Within a standard risk assessment framework, the purpose of the effects characterization is to identify, collate, and evaluate all available ecotoxicity studies. For existing pesticides and well studied industrial chemicals, this could add up to hundreds of studies to evaluate. There are different strategies that can be used to quickly set aside studies that should not be considered in the risk assessment. For example, toxicity studies with an unrealistic exposure pathway (e.g., injection into tissues, in vitro studies) or endpoints not directly related to survival, reproduction and growth do not need to be further evaluated. A tiered approach can be devised to triage the studies and identify those most useful for the risk assessment.

Evaluation schemes need to be flexible enough to handle different types of studies including GLP-compliant and peer-reviewed literature studies. Intrinsik helps companies set up data relevance and quality evaluation rubrics that are suited to the specific need and we have evaluated thousands of different types of studies. Come take advantage of our experience.

For more information, please contact Roger Breton at moc.k1563705983isnir1563705983tni@n1563705983oterb1563705983r1563705983.

Intrinsik Corp. Blogger: Roger Breton, Senior Scientist

References:

Ågerstrand, M., L. Edvardsson and C. Rudén. 2014. Bad reporting or bad science? Systematic data evaluation as a means to improve the use of peer reviewed studies in risk assessments of chemicals. Human Ecol. Risk Assess. 20:1427–1445.
Bevan, C. and D. Strother. 2012. Best practices for evaluating method validity, data quality and study reliability of toxicity studies for chemical hazard risk assessments. Washington (DC): American Chemical Council, Centre for Advancing Risk Assessment Science and Policy. 26 p.
Martin, O.V., J. Adams, A. Beasley, S. Belanger, R.L. Breton, T.C.M. Brock, V.A. Buonsante, M. Galay Burgos, J. Green, P.D. Guiney, T. Hall, M. Hanson, M.J. Harris, T.R. Henry, D. Huggett, M. Junghans, R. Laskowski, G. Maack, C.T.A. Moermond, G. Panter, A. Pease, V. Poulsen, M. Roberts, C. Rudén, C.E. Schlekat, I. Schoeters, K.R. Solomon, J. Staveley, B. Stubblefield, J.P. Sumpter, M. St J. Warne, R. Wentsel, J.R. Wheeler, B.A. Wolff, K. Yamazaki, H. Zahner and M. Ågerstrand. 2019. Improving environmental risk assessments of chemicals: Steps towards evidence-based ecotoxicology. Environ. Int. 128:210-217.
Moermond, C., A. Beasley, R. Breton, M. Junghans, R. Laskowski, K. Solomon and H. Zahner. 2016. Assessing the reliability of ecotoxicological studies: An overview of current needs and approaches. Integr. Environ. Assess. Manag. 13(4):640-651.