Perspectives for integrating human and environmental risk assessment and synergies with socio-economic analysis

International audienceFor more than a decade, the integration of human and environmental risk assessment (RA) has become an attractive vision. At the same time, existing European regulations of chemical substances such as REACH (EC Regulation No. 1907/2006), the Plant Protection Products Regulation (EC regulation 1107/2009) and Biocide Regulation (EC Regulation 528/2012) continue to ask for sector-specific RAs, each of which have their individual information requirements regarding exposure and hazard data, and also use different methodologies for the ultimate risk quantification. In response to this difference between the vision for integration and the current scientific and regulatory practice, the present paper outlines five medium-term opportunities for integrating human and environmental RA, followed by detailed discussions of the associated major components and their state of the art. Current hazard assessment approaches are analyzed in terms of data availability and quality, and covering non-test tools, the integrated testing strategy (ITS) approach, the adverse outcome pathway (AOP) concept, methods for assessing uncertainty, and the issue of explicitly treating mixture toxicity. With respect to exposure, opportunities for integrating exposure assessment are discussed, taking into account the uncertainty, standardization and validation of exposure modeling as well as the availability of exposure data. A further focus is on ways to complement RA by a socio-economic assessment (SEA) in order to better inform about risk management options. In this way, the present analysis, developed as part of the EU FP7 project HEROIC, may contribute to paving the way for integrating, where useful and possible, human and environmental RA in a manner suitable for its coupling with SEA

A novel risk assessment approach for the prioritisation of emerging substances and its application to 500 organic microcontaminants

Given the huge number of chemicals in commerce, there is a need of prioritising chemicals for risk assessment and monitoring. This study is the first to assess the risk of 500 organic substances based on observations in the four European river basins of the Elbe, Scheldt, Danube and Llobregat. A decision tree is introduced that first classifies chemicals into six categories depending on the information available. The priority within each category is then evaluated based on two indicators, the Frequency of Exceedance and the Extent of Exceedance of Predicted No-Effect Concentrations (PNECs). These two indictors are based on maximum environmental concentrations (MEC), rather than commonly used statistically based averages (Predicted Effect Concentration, PEC), and compared to the lowest acute-based (PNEC acute) or chronic-based thresholds (PNEC chronic). For 56% of the compounds, PNECs were available from existing risk assessments, and the majority of these PNECs were derived from chronic toxicity data or simulated ecosystem studies (mesocosm) with rather low assessment factors. The limitations of this concept for risk assessment purposes are discussed. For the remainder, provisional PNECs (P-PNECs) were established from QSAR models for acute toxicity to the standard test organisms Daphnia magna, Pimephales promelas and Selenastrum capricornutum. The prioritisation revealed that about three-quarter of the 44 substances with MEC / PNEC ratios above ten were pesticides

The HEROIC project : coordinated efforts towards the harmonization and cross-fertilization of human and environmental risk assessment of chemical substances

Today, human risk assessment (HRA) and environmental risk assessment (ERA) are typically separated. There is a lack of mutual understanding between experts and data from toxicological and ecotoxicological studies are not readily accessible by risk assessors of the two disciplines. The need for RA will continue to increase (e.g. REACH or toxicity of mixtures) along with budget restrictions and political and public pressure to reduce the number of animal tests. Therefore more cost effective, predictive and rapid tests for high quality sustainable RA are needed, including a better exploitation of existing data. The HEROIC project - a coordination action of the 7th FP - will provide a platform for networking among all the relevant stakeholders in the RA value chain and will provide them with the most relevant background information to contribute to the development of harmonised approaches which meet the challenges of RA. The project will enable the improvement and harmonisation of tools and methods in RA, by exploring how data generated in ecotoxicology and human toxicology can be applied across disciplines for integrated RA, and develop a framework for integrated methodologies and approaches for RA. This will increase transparency in RA and allow better risk communication to maintain public trust and to give unambiguous guidance for improved risk management. HEROIC starts with a comprehensive landscaping exercise to identify common methodological and data needs in current human and environmental risk assessment practices. We will then evaluate existing in-vivo, in-vitro and in-silico methods for hazard and exposure assessment. The selection process ranks and weights data based on their reliability and relevance and uses a Weight-of-Evidence approach to integrate such information to develop an Integrated Testing Strategy (ITS) for decision making. A dedicated web portal called 'Tox-Hub' that presents information from diverse sources and that functions as a central point of access to the most relevant toxicological and ecotoxicological information will be created. A diverse range of dedicated activities is planned for information, dissemination, capacity building and communication. These coordinating activities will result in enhanced sharing of knowledge, building consensus and development of clear, easily understood, transparent and unambiguous integrated RA procedures

ERGO: Breaking Down the Wall between Human Health and Environmental Testing of Endocrine Disrupters

International audienc

Strengthen the European collaborative environmental research to meet European policy goals for achieving a sustainable, non-toxic environment

International audienceTo meet the United Nations (UN) sustainable development goals and the European Union (EU) strategy for a non-toxic environment, water resources and ecosystems management require cost-efficient solutions for prevailing complex contamination and multiple stressor exposures. For the protection of water resources under global change conditions, specific research needs for prediction, monitoring, assessment and abatement of multiple stressors emerge with respect to maintaining human needs, biodiversity, and ecosystem services. Collaborative European research seems an ideal instrument to mobilize the required transdisciplinary scientific support and tackle the large-scale dimension and develop options required for implementation of European policies. Calls for research on minimizing society’s chemical footprints in the water–food–energy–security nexus are required. European research should be complemented with targeted national scientific funding to address specific transformation pathways and support the evaluation, demonstration and implementation of novel approaches on regional scales. The foreseeable pressure developments due to demographic, economic and climate changes require solution-oriented thinking, focusing on the assessment of sustainable abatement options and transformation pathways rather than on status evaluation. Stakeholder involvement is a key success factor in collaborative projects as it allows capturing added value, to address other levels of complexity, and find smarter solutions by synthesizing scientific evidence, integrating governance issues, and addressing transition pathways. This increases the chances of closing the value chain by implementing novel solutions. For the water quality topic, the interacting European collaborative projects SOLUTIONS, MARS and GLOBAQUA and the NORMAN network provide best practice examples for successful applied collaborative research including multi-stakeholder involvement. They provided innovative conceptual, modelling and instrumental options for future monitoring and management of chemical mixtures and multiple stressors in European water resources. Advancement of EU water framework directive-related policies has therefore become an option