Building a European exposure science strategy.

Exposure information is a critical element in various regulatory and non-regulatory frameworks in Europe and elsewhere. Exposure science supports to ensure safe environments, reduce human health risks, and foster a sustainable future. However, increasing diversity in regulations and the lack of a professional identity as exposure scientists currently hamper developing the field and uptake into European policy. In response, we discuss trends, and identify three key needs for advancing and harmonizing exposure science and its application in Europe. We provide overarching building blocks and define six long-term activities to address the identified key needs, and to iteratively improve guidelines, tools, data, and education. More specifically, we propose creating European networks to maximize synergies with adjacent fields and identify funding opportunities, building common exposure assessment approaches across regulations, providing tiered education and training programmes, developing an aligned and integrated exposure assessment framework, offering best practices guidance, and launching an exposure information exchange platform. Dedicated working groups will further specify these activities in a consistent action plan. Together, these elements form the foundation for establishing goals and an action roadmap for successfully developing and implementing a 'European Exposure Science Strategy' 2020-2030, which is aligned with advances in science and technology.

Environmental risk assessment of pesticides: state of the art and prospective improvement from science.

Pesticide risk assessment in the European regulatory framework is mandatory performed for active substances (pesticides) and the plant protection products they are constituents of. The aim is to guarantee that safe use can be achieved for the intended use of the product. This paper provides a feedback on the regulatory environmental risk assessment performed for pesticide registration at the EU and member state levels. The different steps of pesticide registration are addressed considering both exposure and hazard. In this paper, we focus on the environmental fate and behaviour in surface water together with the aquatic ecotoxicity of the substances to illustrate pesticide regulatory risk assessment performed for aquatic organisms. Current methodologies are presented along with highlights on potential improvements. For instance, as regards exposure aspects, moving from field based to landscape risk assessments is promising. Regarding ecotoxicology, ecological models may be valuable tools when applied to chemical risk assessment. In addition, interest and further developments to better take into account mitigation measures in risk assessment and management are also presented.

Assessing the relevance of ecotoxicological studies for regulatory decision making.

Regulatory policies in many parts of the world recognize either the utility of or the mandate that all available studies be considered in environmental or ecological hazard and risk assessment (ERA) of chemicals, including studies from the peer-reviewed literature. Consequently, a vast array of different studies and data types need to be considered. The first steps in the evaluation process involve determining whether the study is relevant to the ERA and sufficiently reliable. Relevance evaluation is typically performed using existing guidance but involves application of "expert judgment" by risk assessors. In the present paper, we review published guidance for relevance evaluation and, on the basis of the practical experience within the group of authors, we identify additional aspects and further develop already proposed aspects that should be considered when conducting a relevance assessment for ecotoxicological studies. From a regulatory point of view, the overarching key aspect of relevance concerns the ability to directly or indirectly use the study in ERA with the purpose of addressing specific protection goals and ultimately regulatory decision making. Because ERA schemes are based on the appropriate linking of exposure and effect estimates, important features of ecotoxicological studies relate to exposure relevance and biological relevance. Exposure relevance addresses the representativeness of the test substance, environmental exposure media, and exposure regime. Biological relevance deals with the environmental significance of the test organism and the endpoints selected, the ecological realism of the test conditions simulated in the study, as well as a mechanistic link of treatment-related effects for endpoints to the protection goal identified in the ERA. In addition, uncertainties associated with relevance should be considered in the assessment. A systematic and transparent assessment of relevance is needed for regulatory decision making. The relevance aspects also need to be considered by scientists when designing, performing, and reporting ecotoxicological studies to facilitate their use in ERA. Integr Environ Assess Manag 2017;13:652-663. © 2016 The Authors. Integrated Environmental Assessment and Management published by Wiley Periodicals, Inc. on behalf of Society of Environmental Toxicology & Chemistry (SETAC).

Ecosystem services in risk assessment and management.

The ecosystem services (ES) concept holds much promise for environmental decision making. Even so, the concept has yet to gain full traction in the decisions and policies of environmental agencies in the United States, Europe, and elsewhere. In this paper we examine the opportunities for and implications of including ES in risk assessments and the risk management decisions that they inform. We assert that use of ES will: 1) lead to more comprehensive environmental protection; 2) help to articulate the benefits of environmental decisions, policies, and actions; 3) better inform the derivation of environmental quality standards; 4) enable integration of human health and ecological risk assessment; and 5) facilitate horizontal integration of policies, regulations, and programs. We provide the technical basis and supporting rationale for each assertion, relying on examples taken from experiences in the United States and European Union. Specific recommendations are offered for use of ES in risk assessment and risk management, and issues and challenges to advancing use of ES are described together with some of the science needed to improve the value of the ES concept to environmental protection. Integr Environ Assess Manag 2017;13:62-73. © 2016 SETAC.

Modelling survival: exposure pattern, species sensitivity and uncertainty.

The General Unified Threshold model for Survival (GUTS) integrates previously published toxicokinetic-toxicodynamic models and estimates survival with explicitly defined assumptions. Importantly, GUTS accounts for time-variable exposure to the stressor. We performed three studies to test the ability of GUTS to predict survival of aquatic organisms across different pesticide exposure patterns, time scales and species. Firstly, using synthetic data, we identified experimental data requirements which allow for the estimation of all parameters of the GUTS proper model. Secondly, we assessed how well GUTS, calibrated with short-term survival data of Gammarus pulex exposed to four pesticides, can forecast effects of longer-term pulsed exposures. Thirdly, we tested the ability of GUTS to estimate 14-day median effect concentrations of malathion for a range of species and use these estimates to build species sensitivity distributions for different exposure patterns. We find that GUTS adequately predicts survival across exposure patterns that vary over time. When toxicity is assessed for time-variable concentrations species may differ in their responses depending on the exposure profile. This can result in different species sensitivity rankings and safe levels. The interplay of exposure pattern and species sensitivity deserves systematic investigation in order to better understand how organisms respond to stress, including humans.

An ecosystem services approach to pesticide risk assessment and risk management of non-target terrestrial plants: recommendations from a SETAC Europe workshop.

The registration of plant protection products (PPPs) in the EU is under Regulation 1107/2009, which recommends a tiered approach to assessing the risk to non-target terrestrial plants (NTTPs). However, little information is provided on how to perform and implement higher tier studies or how to use them to refine the risk assessments. Therefore, a stakeholder workshop was organized to consolidate current knowledge and expertise to aid the further development of testing and assessment procedures for NTTPs. This brief communication highlights the agreed recommendations of the workshop, which relate to the three main themes, i.e. specific protection goals, risk assessment and mitigation. The participants of the workshop adopted the European Food Safety Authority (EFSA) approach of using an ecosystem services framework for identifying specific protection goals. First, delivery and protection of ecosystem services were discussed for in-crop, in-field and off-crop, and off-field areas. Second, lower and higher tier risk assessment methods, including modelling approaches, were evaluated. Third, options for risk mitigation of spray drift and run-off were discussed and evaluated. Several important knowledge gaps were identified, and specific data collation and literature-based tasks were actioned to begin to address them. A full workshop report is planned for the fall of 2014.

AMEG: the new SETAC advisory group on aquatic macrophyte ecotoxicology.

INTRODUCTION AND BACKGROUND: Primary producers play critical structural and functional roles in aquatic ecosystems; therefore, it is imperative that the potential risks of toxicants to aquatic plants are adequately assessed in the risk assessment of chemicals. The standard required macrophyte test species is the floating (non-sediment-rooted) duckweed Lemna spp. This macrophyte species might not be representative of all floating, rooted, emergent, and submerged macrophyte species because of differences in the duration and mode of exposure; sensitivity to the specific toxic mode of action of the chemical; and species-specific traits (e.g., duckweed's very short generation time). DISCUSSION AND PERSPECTIVES: These topics were addressed during the workshop entitled "Aquatic Macrophyte Risk Assessment for Pesticides" (AMRAP) where a risk assessment scheme for aquatic macrophytes was proposed. Four working groups evolved from this workshop and were charged with the task of developing Tier 1 and higher-tier aquatic macrophyte risk assessment procedures. Subsequently, a SETAC Advisory Group, the Macrophyte Ecotoxicology Group (AMEG) was formed as an umbrella organization for various macrophyte working groups. The purpose of AMEG is to provide scientifically based guidance in all aspects of aquatic macrophyte testing in the laboratory and field, including prospective as well as retrospective risk assessments for chemicals. As AMEG expands, it will begin to address new topics including bioremediation and sustainable management of aquatic macrophytes in the context of ecosystem services.

Selecting a battery of bioassays for ecotoxicological characterization of wastes.

This study was conducted in France within the context of waste classification (Hazardous Waste Council Directive 91/689/EEC), and focused on "ecotoxic" property (H14). In 1998, an experimental test strategy was developed to assess ecotoxicological properties of wastes using a battery of six standardized bioassays. This combined direct and indirect approaches integrating two solid-phase tests: emergence and growth inhibition of Lactuca sativa (14 days), mortality of Eisenia fetida (14 days) and four standardized tests performed on water extracts from wastes: growth inhibition of Pseudokirchneriella subcapitata (3 days), inhibition of mobility of Daphnia magna (48 h), inhibition of reproduction of Ceriodaphnia dubia (7 days), inhibition of light emission of Vibrio fischeri (30 min). This study aimed to set up preliminary conclusions on relevancy of this experimental test strategy, based on data obtained since 1998. Results were analyzed from the combined use of Hierarchical Cluster Analysis, Principal Component Analysis and Nonlinear Mapping. These multivariate analyses clearly showed that it was possible to reduce this number of tests without changing the typology of the wastes. A battery of bioassays including one solid phase test and two tests performed on water extracts (L. sativa, V. fischeri and C. dubia) was found as an optimal solution for characterizing the toxicity of the studied wastes. This optimal battery represents a good basis for determining the H14 property.

Ecotoxicity of ethylene glycol monomethyl ether and its acetate.

Ethylene glycol monomethyl ether (EGME) and ethylene glycol monomethyl ether acetate (EGMEA) have been tested for their acute and chronic toxicity to various organisms occupying different trophic levels in the aquatic ecosystems. The results obtained in this study and those collected from the literature clearly reveal that EGME does not present short- or long-term ecotoxic effects in the ranges of concentrations likely to be found in aquatic environments. Indeed, in general, concentrations of 1000 to 10,000 mg/L of EGME are necessary before significant adverse effects can be observed in aquatic species. Conversely, acute toxicity occurs in fish at about 50 mg/L of EGMEA, and reproduction of Ceriodaphnia dubia is affected by 0.06 mg/L of this chemical. A teratogenic effect-with a specific malformation of the eyes-occurs in Xenopus laevis in the presence of 75 mg/L of EGMEA. This study was partially supported by the French Ministry of the Environment as part of the PNETOX program (1998).

Ecotoxicity of ethylene glycol monobutyl ether and its acetate.

Ethylene glycol monobutyl ether (EGBE) and ethylene glycol monobutyl ether acetate (EGBEA) were tested for their acute and chronic toxicity to various organisms occupying different trophic levels in the aquatic ecosystems. The obtained results and those collected from the literature clearly show that EGBE affects the survival, growth, and reproduction of aquatic organisms only at concentrations of approximately 100 mg/L or more. EGBEA appears to be slightly more ecotoxic to aquatic species. At 1000 and 10,000 mg/L, both chemicals strongly affect the early stages of development of the Japanese oyster, but such concentrations are too high to be found in aquatic environments. Micronucleus tests on Xenopus laevis show that EGBE and EGBEA are not genotoxic in the range of concentrations tested. Consequently, neither chemical presents a risk to the aquatic environment. EGBE does affect the gonadosomatic index of adult male zebra fish (Danio rerio); however, these are preliminary results and must be confirmed by additional experiments. This study was partially supported by the French Ministry of the Environment as part of the PNETOX program (1998).