Quality Criteria for Microplastic Effect Studies in the Context of Risk Assessment: A Critical Review.

In the literature, there is widespread consensus that methods in plastic research need improvement. Current limitations in quality assurance and harmonization prevent progress in our understanding of the true effects of microplastic in the environment. Following the recent development of quality assessment methods for studies reporting concentrations in biota and water samples, we propose a method to assess the quality of microplastic effect studies. We reviewed 105 microplastic effect studies with aquatic biota, provided a systematic overview of their characteristics, developed 20 quality criteria in four main criteria categories (particle characterization, experimental design, applicability in risk assessment, and ecological relevance), propose a protocol for future effect studies with particles, and, finally, used all the information to define the weight of evidence with respect to demonstrated effect mechanisms. On average, studies scored 44.6% (range 20-77.5%) of the maximum score. No study scored positively on all criteria, reconfirming the urgent need for better quality assurance. Most urgent recommendations for improvement relate to avoiding and verifying background contamination, and to improving the environmental relevance of exposure conditions. The majority of the studies (86.7%) evaluated on particle characteristics properly, nonetheless it should be underlined that by failing to provide characteristics of the particles, an entire experiment can become irreproducible. Studies addressed environmentally realistic polymer types fairly well; however, there was a mismatch between sizes tested and those targeted when analyzing microplastic in environmental samples. In far too many instances, studies suggest and speculate mechanisms that are poorly supported by the design and reporting of data in the study. This represents a problem for decision-makers and needs to be minimized in future research. In their papers, authors frame 10 effects mechanisms as "suggested", whereas 7 of them are framed as "demonstrated". When accounting for the quality of the studies according to our assessment, three of these mechanisms remained. These are , , and . We recommend that risk assessment addresses these mechanisms with higher priority.