Robert Kase

The European technical report on aquatic effect-based monitoring tools under the water framework directive

The Water Framework Directive (WFD), 2000/60/EC, requires an integrated approach to the monitoring and assessment of the quality of surface water bodies. The chemical status assessment is based on compliance with legally binding Environmental Quality Standards (EQSs) for selected chemical pollutants (priority substances) of EU-wide concern. In the context of the mandate for the period 2010 to 2012 of the subgroup Chemical Monitoring and Emerging Pollutants (CMEP) under the Common Implementation Strategy (CIS) for the WFD, a specific task was established for the elaboration of a technical report on aquatic effect-based monitoring tools. The activity was chaired by Sweden and co-chaired by Italy and progressively involved several Member States and stakeholders in an EU-wide drafting group. The main aim of this technical report was to identify potential effect-based tools (e.g. biomarkers and bioassays) that could be used in the context of the different monitoring programmes (surveillance, operational and investigative) linking chemical and ecological status assessment. The present paper summarizes the major technical contents and findings of the report.

CRED: Criteria for reporting and evaluating ecotoxicity data.

Predicted-no-effect concentrations (PNECs) and environmental quality standards (EQSs) are derived in a large number of legal frameworks worldwide. When deriving these safe concentrations, it is necessary to evaluate the reliability and relevance of ecotoxicity studies. Such evaluation is often subject to expert judgment, which may introduce bias and decrease consistency when risk assessors evaluate the same study. The Criteria for Reporting and Evaluating Ecotoxicity Data (CRED) project attempts to address this problem. It aims to improve the reproducibility, transparency, and consistency of reliability and relevance evaluations of aquatic ecotoxicity studies among regulatory frameworks, countries, institutes, and individual assessors. In the present study, the CRED evaluation method is presented. It includes a set of 20 reliability and 13 relevance criteria, accompanied by extensive guidance. Risk assessors who participated in the CRED ring test evaluated the CRED evaluation method to be more accurate, applicable, consistent, and transparent than the often-used Klimisch method. The CRED evaluation method is accompanied by reporting recommendations for aquatic ecotoxicity studies, with 50 specific criteria divided into 6 categories: general information, test design, test substance, test organism, exposure conditions, and statistical design and biological response. An ecotoxicity study in which all important information is reported is more likely to be considered for regulatory use, and proper reporting may also help in the peer-review process.

Impact of environmental estrogens on Yfish considering the diversity of estrogen signaling.

Research on endocrine disruption in fish has been dominated by studies on estrogen-active compounds which act as mimics of the natural estrogen, 17β-estradiol (E2), and generally exert their biological actions by binding to and activation of estrogen receptors (ERs). Estrogens play central roles in reproductive physiology and regulate (female) sexual differentiation. In line with this, most adverse effects reported for fish exposed to environmental estrogens relate to sexual differentiation and reproduction. E2, however, utilizes a variety of signaling mechanisms, has multifaceted functions and targets, and therefore the toxicological and ecological effects of environmental estrogens in fish will extend beyond those associated with the reproduction. This review first describes the diversity of estrogen receptor signaling in fish, including both genomic and non-genomic mechanisms, and receptor crosstalk. It then considers the range of non-reproductive physiological processes in fish that are known to be responsive to estrogens, including sensory systems, the brain, the immune system, growth, specifically through the growth hormone/insulin-like growth factor system, and osmoregulation. The diversity in estrogen responses between fish species is then addressed, framed within evolutionary and ecological contexts, and we make assessments on their relevance for toxicological sensitivity as well as ecological vulnerability. The diversity of estrogen actions raises questions whether current risk assessment strategies, which focus on reproductive endpoints, and a few model fish species only, are protective of the wider potential health effects of estrogens. Available - although limited - evidence nevertheless suggests that quantitative environmental threshold concentrations for environmental protection derived from reproductive tests with model fish species are protective for non-reproductive effects as well. The diversity of actions of estrogens across divergent physiological systems, however, may lead to and underestimation of impacts on fish populations as their effects are generally considered on one functional process only and this may underrepresent the impact on the different physiological processes collectively.

In vitro bioassays to screen for endocrine active pharmaceuticals in surface and waste waters

In the context of the European Water Framework Directive (WFD) it is fully recognized that pharmaceuticals can represent a relevant issue for the achievement of the good chemical and ecological status of European surface water bodies. The recent European Directive on the review of priority substances in surface water bodies has included three pharmaceuticals of widespread use (diclofenac, 17α-ethinylestradiol (EE2), 17β-estradiol (E2)) in the European monitoring list, the so-called watch list. Endocrine active pharmaceuticals such as EE2 and E2 (also occurring as natural hormone) can cause adverse effects on aquatic ecosystems at very low levels. However, monitoring of these pharmaceuticals within the watch list mechanism of the WFD and national monitoring programs can be difficult because of detection problems of most routine analytical methods. With proposed annual average Environmental Quality Standards (AA-EQS) of 0.035 ng/L and 0.4 ng/L, respectively, the estrogenic pharmaceutical EE2 and the natural hormone E2 are among those substances. Sensitive in vitro bioassays could reduce the current detection problems by measuring the estrogenic activity of environmental samples. In a short review article the application of this approach to screen and assess the risks of endocrine active pharmaceuticals with a focus on estrogenic pharmaceuticals in environmental waters is discussed.

Assessment of micropollutants from municipal wastewater - Combination of exposure and ecotoxicological effect data for Switzerland

Micropollutants (MPs) from municipal wastewater are frequently detected in surface waters and occur in ecotoxicologically relevant concentrations. Therefore a broadly accepted method for the assessment of MPs is needed. Here we propose a procedure for the assessment of MPs from municipal wastewater. The method suggested comprises (1) an approach for the identification of potentially polluted sites, (2) a compilation of a substance list with relevant MPs, (3) (eco)toxicologically based quality criteria, (4) a sampling strategy that considers the input-dynamics of chemicals and (5) a scheme to rate water quality with respect to MP contamination. In the proposed concept the assessment focuses upon those substances found repeatedly in municipal wastewaters (continuous inputs). Additionally, we explain how the Environmental Quality Standard (EQS) proposals were derived in accordance with the Water Framework Directive (WFD), and the currently developed Technical Guidance Document for EQS (TGD for EQS). Based on the proposed EQS, we provide a Swiss-wide risk assessment for 6 selected MPs.

Criteria for Reporting and Evaluating ecotoxicity Data (CRED): comparison and perception of the Klimisch and CRED methods for evaluating reliability and relevance of ecotoxicity studies

BackgroundThe regulatory evaluation of ecotoxicity studies for environmental risk and/or hazard assessment of chemicals is often performed using the method established by Klimisch and colleagues in 1997. The method was, at that time, an important step toward improved evaluation of study reliability, but lately it has been criticized for lack of detail and guidance, and for not ensuring sufficient consistency among risk assessors.Results A new evaluation method was thus developed: Criteria for Reporting and Evaluating ecotoxicity Data (CRED). The CRED evaluation method aims at strengthening consistency and transparency of hazard and risk assessment of chemicals by providing criteria and guidance for reliability and relevance evaluation of aquatic ecotoxicity studies. A two-phased ring test was conducted to compare and characterize the differences between the CRED and Klimisch evaluation methods. A total of 75 risk assessors from 12 countries participated. Results show that the CRED evaluation method provides a more detailed and transparent evaluation of reliability and relevance than the Klimisch method. Ring test participants perceived it to be less dependent on expert judgement, more accurate and consistent, and practical regarding the use of criteria and time needed for performing an evaluation.ConclusionsWe conclude that the CRED evaluation method is a suitable replacement for the Klimisch method, and that its use may contribute to an improved harmonization of hazard and risk assessments of chemicals across different regulatory frameworks.

Effect-based trigger values for in vitro and in vivo bioassays performed on surface water extracts supporting the environmental quality standards (EQS) of the European Water Framework Directive

Effect-based methods including cell-based bioassays, reporter gene assays and whole-organism assays have been applied for decades in water quality monitoring and testing of enriched solid-phase extracts. There is no common EU-wide agreement on what level of bioassay response in water extracts is acceptable. At present, bioassay results are only benchmarked against each other but not against a consented measure of chemical water quality. The EU environmental quality standards (EQS) differentiate between acceptable and unacceptable surface water concentrations for individual chemicals but cannot capture the thousands of chemicals in water and their biological action as mixtures. We developed a method that reads across from existing EQS and includes additional mixture considerations with the goal that the derived effect-based trigger values (EBT) indicate acceptable risk for complex mixtures as they occur in surface water. Advantages and limitations of various approaches to read across from EQS are discussed and distilled to an algorithm that translates EQS into their corresponding bioanalytical equivalent concentrations (BEQ). The proposed EBT derivation method was applied to 48 in vitro bioassays with 32 of them having sufficient information to yield preliminary EBTs. To assess the practicability and robustness of the proposed approach, we compared the tentative EBTs with observed environmental effects. The proposed method only gives guidance on how to derive EBTs but does not propose final EBTs for implementation. The EBTs for some bioassays such as those for estrogenicity are already mature and could be implemented into regulation in the near future, while for others it will still take a few iterations until we can be confident of the power of the proposed EBTs to differentiate good from poor water quality with respect to chemical contamination.

The Emerging Contaminants in the Context of the EU Water Framework Directive

The WFD (Water Framework Directive) requires that good chemical status of surface waterbodies is achieved by all member states of the European Union by 2015. The assessment of the chemical status is based on monitoring of the list of priority substances included in the Annex X of the WFD. In August 2013, the Directive 2013/39/EU has been published and contains a revised list of priority substances for the European aquatic environments and the derivation of environmental quality standards in the water column and biota: 12 new substances were selected through a procedure of prioritisation based on a simplified risk assessment methodology with the use of monitoring and modelling data collected over a period of 4 years. In the list of the 12 new substances, also emerging contaminants and some biocides are included. The Commission is establishing a so-called watch list of substances for which Union-wide monitoring data are to be gathered for the purpose of supporting future prioritisation exercises. For the substances diclofenac, beta-estradiol (E2) and 17-alpha-ethinylestradiol (EE2), the Directive has foreseen a monitoring obligation in order to gather data to facilitate the determination of appropriate measures to address the risk to surface waters posed by those substances. Furthermore, on the basis of the outcome of a study on the risks posed by medicinal products in the environment and of other relevant studies and reports, the Commission shall develop a strategic approach to pollution of water by pharmaceutical substances.

Scientific Basis for Regulatory Decision-Making of Nanomaterials Report on the Workshop, 20-21 January 2014, Center of Applied Ecotoxicology, Dübendorf.

The key findings of a workshop jointly organized by the Swiss Centre of Applied Ecotoxicity, the Swiss Centre for Applied Human Toxicology (SCAHT), and the Federal Office of Public Health (FOPH) are summarized and provide a critical analysis of the current regulatory framework for nanomaterials and a snapshot of some hot topics in nanoscience.The key findings of a workshop jointly organized by the Swiss Centre of Applied Ecotoxicity, the Swiss Centre for Applied Human Toxicology (SCAHT), and the Federal Office of Public Health (FOPH) are summarized and provide a critical analysis of the current regulatory framework for nanomaterials and a snapshot of some hot topics in nanoscience.