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The Hazard Quotient (HQ) compares field application rate to intrinsic toxicity assessed with sensitive indicator species. As a hazard indicator for risk assessment, the HQ must be calibrated against measured effects under field conditions. Because protection goals may be context specific, we analyse how choice of acceptance criteria affects setting of the HQ and calibrate HQ for various scenarios under the strict condition that no false negative conclusions may be reached. We use Non-Target Arthropod toxicity data from laboratory studies on inert (Tier 1) and on natural substrates (Tier 2) and calibrate the HQ using application rates and arthropod abundance counts from field studies in orchards, arable fields, and hay meadows in 34 locations in Western Europe. With 21 formulations (17 active substances) tested in mostly multi-rate field studies, our reference data base has 120/121 values at Tier 1/Tier 2, respectively. We use the Proportion of Affected Taxa and Duration of Effect to jointly define acceptance criteria, starting with No Observed Effects. Absence of field effects is correctly predicted with HQ

This paper complements recent considerations of specific protection goals (SPG) to inform risk assessments for non‐target terrestrial plants (NTTP) in the European Union. The SPG options in‐field appear to be of the most disruptive potential from agronomic perspective and are therefore investigated in more detail. Overarching prerequisites have been identified that need to be accounted for to ensure that any of the potential SPG options remain operational in a sustainable agricultural context. As soon as crop production is considered a desired ecosystem service for the in‐field, its specific requirements in the context of sustainable agriculture have to be factored in. Good agricultural practices (GAPs), potential ecosystem disservices (e.g. weeds, pests and diseases) and supporting and regulating services need to be considered to ensure a successful and sustainable delivery of the ecosystem service crop production. Concerning in‐field SPG options for NTTP specifically GAPs related to integrated weed management (IWM) require detailed assessment, as they individually and in combination have the purpose of weed control. Therefore, they result in specific implications to the environment, ecosystem services and biodiversity within the context of sustainable agricultural production. When diverging in‐field ecosystem services are considered for the same context, the protection goals options require an additional assessment of synergies and trade‐offs between the relevant ecosystem services (e.g. crop production, climate regulation and aesthetic values), a corresponding weighing and prioritization. Similarly, for biodiversity conservation, the trade‐offs and synergies between sustainable crop production and specific habitat requirements need to be accounted for. Consequently, an interdisciplinary approach can ensure that SPG are operational by integrating a broad understanding of cropping systems, the environmental impact of the tools a farmer uses and the link between habitat availability, the impact of any of the applied tools on habitat quality and the broader landscape context. Integr Environ Assess Manag 2021;17:905–910. © 2021 Bayer AG, BASF SE and Syngenta. Integrated Environmental Assessment and Management published by Wiley Periodicals LLC on behalf of Society of Environmental Toxicology & Chemistry (SETAC). KEY POINTS: An interdisciplinary approach can ensure that specific protection goals for environmental risk assessments for crop protection products are operational and realistic in a sustainable agricultural context.Tools and management strategies used within sustainable agriculture and the natural environment interact with each other and can exert both positive and negative effects, respectively, thus requiring a holistic approach for setting specific protection goals.In particular, the sustainable delivery of the ecosystem service "crop production" comes with agronomical and environmental constraints that both need to be accounted for when defining in‐field specific protection goals for crop protection.Ecosystem services delivery and biodiversity conservation also have inherent trade‐offs and synergies that need to be considered and prioritized within the derivation of specific protection goals. [ABSTRACT FROM AUTHOR]

Protecting the structure and functioning of soil ecosystems is one of the central aims of current regulations of chemicals. This is, for instance, shown by the emphasis on the protection of key drivers and ecosystem services as proposed in the protection goal options for soil organisms by the European Food Safety Authority (EFSA). Such targets require insight into soil biodiversity, its role in the functioning of ecosystems, and the way it responds to stress. Also required are tools and methodologies for properly assessing biodiversity. To address these issues, the Society of Environmental Toxicology and Chemistry (SETAC) Europe 14th Special Science Symposium (SESSS14) was held 19 to 20 November 2019 in Brussels, Belgium. The central aim of the SESSS14 was to provide information on how to include soil biodiversity and soil functions as protection goal options in the risk assessment and quantification of the effects of chemicals and other stressors (including their respective regulations). This paper is based on the presentations and discussions at the SESSS14 and will give a brief update on the scientific state-of-the art on soil biodiversity, novel scientific developments, experimental and modeling approaches, as well as case studies. It will also discuss how these approaches could inform future risk assessment of chemicals and other stressors in the regulatory context of protecting soil ecosystems. [ABSTRACT FROM AUTHOR]

In the EFSA guidance document for the assessment of risk of plant protection products for bees the screening and tier I trigger for chronic risk to bees is linked to a trigger value which is intended to meet a certain level of protection. However, the methods used to derive the trigger of 0.03 do not take into account several factors including the shape and nature of the dose-repose used to generate the endpoint. This means that the resultant proposed trigger leads to a large over estimation of risk with a large number of compounds failing the risk assessment and being incorrectly identified as a higher chronic risk to honey bees. We analyzed the methods used in the selection of the trigger of 0.03 and propose simple adaptations to evaluate all active substances to the same level of protection by taking into account the type of endpoint and the dose response relationship. We found that by using the correct dose-response relationships we could accurately ensure that the desired level of protection was met. We checked our proposal using real-life examples of seven substances registered for use within the European Union and discuss how these proposals could be used to inform risk assessors and risk managers as well as potentially reducing the number of false positive and negatives in a risk assessment.

• The application of gene drives is a powerful new tool to control insect populations. • Concerns exists regarding the environmental consequences of gene drive applications. • Experience in assessing risks of control methods using living organisms exists. • We do not envisage any unforeseen novel risks with the use of gene drive organisms. • Existing frameworks can assist the risk assessment of insects carrying gene drives. The application of (synthetic) gene drives is a powerful tool to control populations of insects that are agricultural pests, vectors of diseases, or a threat to biodiversity potentially leading to the local or global eradication of a species. The potential use of gene drive organisms has triggered a heated discussion regarding their environmental impacts and regulatory oversight. However, experience exists in assessing the environmental impacts of a number of established agricultural pest control methods that require the release of living organisms, that provide high levels of area-wide control and that might be irreversible. This includes classical biological control, the sterile insect technique, the incompatible insect technique that is based on the cytoplasmic incompatibility caused by Wolbachia endosymbionts, and genetically modified insects containing self-limiting traits. The different technologies are described, the regulatory practice and experience is summarized and pathways through which these control technologies could harm valued ecosystem services are presented. With a focus on the application of gene drives in agriculture, using the invasive Drosophila suzukii (Diptera: Drosophilidae) as a case study we then discuss to what extent the existing frameworks could assist the risk assessment of insects carrying gene drives. We suggest that drawing on existing practices, experiences and legislative frameworks will provide a pragmatic and proportionate approach to evaluate the environmental risks of novel solutions based on gene drive technologies. [ABSTRACT FROM AUTHOR]

The Genetically Modified Organisms Biosafety Law in Mexico indicates the requirement of an Environmental Risk Evaluation (ERE) as part of the requisites that should be in an application for the environmental release of Genetically Modified Organisms (GMOs) in Experimental Stage. The biotechnology model of genetically modified common bean with the defensin gene (pdf1.2) of Arabidopsis thaliana has wide-spectrum tolerance against phytopathogenic fungi, therefore the ERE focused on the possible risks this characteristic could pose to their environmental release. The ERE was carried out in two parts, and this first document focused on the definition of the problem or identifying the hazard based on the characteristics of the common bean-pdf1.2, as well as its receiving environment. The identification of the hazards was framed in the political protection goals for Mexico, established as protection of the environment, of the biological diversity, and plant, animal and aquaculture health; and from these, the operative protection goals derived, related to protecting the non-target organisms, avoiding competitive capacity or as weed-behaviors of the common bean-pdf1.2 plant, limiting the development of the resistance of pathogenic microorganisms and avoiding the gene flow to wild relatives and conventional crops in the experimental agroecosystem. The final evaluation points, defined as the quantitative variables susceptible to some adverse effect were identified as the effect on the diversity of non-target microorganisms, the competitive capacity of the crop, and the development of resistance of target organisms. Finally, risk hypotheses were set forth to identify the risks that the release of the common bean-pdf1.2 could cause in the final evaluation points. These risk hypotheses will be analyzed in terms of characterization and its estimation, as well as ERE biosecurity measures in a second document. [ABSTRACT FROM AUTHOR]

In recent years there has been growing concern regarding the sudden and unexplained failure of honeybee (Apis mellifera) colonies. Several factors have been suggested, including pesticides. In an effort to regulate their impact, guidance published by the European Food Safety Authority (EFSA) has recommended that the magnitude of effects on exposed colonies should not exceed 7% reduction in colony size after 2 brood cycles. However, fears have been raised regarding the practicality of measuring such a loss in the field. It is also unclear how this protection goal relates to maintaining the ecosystem services provided by bees, which we argue should be a primary objective for regulators. Here, we evaluate what these protection goals mean in relation to ecosystems performance using a computational colony model that incorporates mechanisms to simulate both lethal and sublethal pesticide effects. To these simulations, we apply a testing regime similar to that commonly used in field trials to produce standard assessment metrics. By relating these measures to losses in forager activity, we aim to identify which could be used as effective indicators of reduced ecoservice and to quantify acceptable limits below which performance can be maintained. Our findings show that loss of colony size is the best indicator of reduced ecoservice. Metrics that focus on specific colony functions such as increased brood or forager mortality are ineffective indicators for all types of simulated pesticide effects. At the levels of colony loss recommended by EFSA, using our default parameterization, we predict a loss of ecosystems performance of 3% to 4%. However, based on an extensive sensitivity analysis, it is clear that this estimate is subject to substantial uncertainty with losses under alternative parameterizations of up to 14%. Nevertheless, our model provides a valuable framework for assessing protection goals, allowing regulators to test relevant impacts and quantify their magnitude. Integr Environ Assess Manag 2018;14:750–758. © 2018 Crown Copyright and SETAC Key Points: A colony model was developed for simulating regulatory field trials of pesticide exposure on honeybees.The model was used to evaluate EFSA protection goals in terms of impact on ecosystem service.Of standard field metrics, colony loss is the only indicator of impaired ecosystem service.For a 7% colony loss, the model predicts maximum foraging losses of between 0% and 14%. [ABSTRACT FROM AUTHOR]

Abstract Following a request from EFSA, the Panel on Plant Protection Products and their Residues developed an opinion on the science to support the potential development of a risk assessment scheme of plant protection products for amphibians and reptiles. The coverage of the risk to amphibians and reptiles by current risk assessments for other vertebrate groups was investigated. Available test methods and exposure models were reviewed with regard to their applicability to amphibians and reptiles. Proposals were made for specific protection goals aiming to protect important ecosystem services and taking into consideration the regulatory framework and existing protection goals for other vertebrates. Uncertainties, knowledge gaps and research needs were highlighted.

The reporting of teosinte and maize × teosinte hybrid plants in maize fields in Spain and France has fuelled the continuing debate on the environmental risks and benefits of genetically modified (GM) crops in Europe. Concern has been expressed that GM maize may hybridise with teosinte or maize × teosinte hybrids, leading to the development of invasive weeds that pose unconsidered risks to the environment. In order to assess these risks, we hypothesised plausible pathways to harm from the cultivation and import of GM maize events MON810, Bt11, 1507 and GA21 for situations where GM maize plants and teosinte/maize × teosinte hybrids are sympatric. This enabled identification of events that must occur for harm to occur, and derivation of risk hypotheses about the likelihood and severity of these events. We tested these risk hypotheses using relevant available information. Overall, we conclude that the envisaged harmful effects to the environment arising from gene flow from GM maize to teosinte/maize × teosinte hybrids when cultivating or importing current commercial varieties of GM insect-resistant and herbicide-tolerant maize would be no greater than those from conventional maize: neither trait is likely to increase the abundance of teosinte or maize × teosinte progeny. Regardless of the likelihood of gene flow to teosinte or maize × teosinte hybrids, continuous cultivation of herbicide-tolerant maize, along with the repeated and exclusive application of the relevant herbicide, should be avoided in order to maintain the effectiveness of weed management. While scientific uncertainties about certain steps in the pathways remain, the risk assessment can be completed, using worst-case assumptions to handle these uncertainties. [ABSTRACT FROM AUTHOR]

Following a request from EFSA, the Panel on Plant Protection Products and their Residues developed an opinion on the science to support the potential development of a risk assessment scheme of plant protection products for amphibians and reptiles. The coverage of the risk to amphibians and reptiles by current risk assessments for other vertebrate groups was investigated. Available test methods and exposure models were reviewed with regard to their applicability to amphibians and reptiles. Proposals were made for specific protection goals aiming to protect important ecosystem services and taking into consideration the regulatory framework and existing protection goals for other vertebrates. Uncertainties, knowledge gaps and research needs were highlighted.This publication is linked to the following EFSA Supporting Publications article: http://onlinelibrary.wiley.com/doi/10.2903/sp.efsa.2018.EN-1357/full [ABSTRACT FROM AUTHOR]

Assessment of the risk to aquatic organisms is an important aspect of pesticide registration. This assessment must be based on well-defined exposure assessment goals (EAGs). However, these goals have not yet been defined for the EU authorization procedure. The definition of an aquatic EAG has seven elements, including: type of water body, spatial dimension of this body, spatial population of water bodies, multi-year temporal population of concentrations for a single water body, and the space-time percentile combination to be selected from the spatio-temporal population of concentrations. The seven elements are split into 16 items, three which are within the risk-management domain. The remaining 13 scientific items should preferably be based on consistency with landscape-level approaches. Subdivision of the spatial population of water bodies on the occurrence of exposure routes should be avoided (although this is current practice). The multi-year temporal population of concentrations should be based on all years in rotational crops (including years without applications). Risk managers should be offered a suite of coherent packages of EAGs and effect assessment goals from which they can select the package corresponding to the desired overall level of protection. © 2017 Society of Chemical Industry [ABSTRACT FROM AUTHOR]

In the environmental risk assessment (ERA) of genetically modified plants (GMP), the consideration of the different environments where genetically modified plants (GMP) will be commercially grown (the receiving environments) plays a crucial role. In addition, relevant protection goals which may be adversely affected by the GMP have to be considered during the ERA. Using a literature- and GIS-based approach, distribution data of protected lepidopteran species listed in Council Directive 92/43/EEC and of maize cultivation was used in order to evaluate potential spatial overlaps between GM maize and protected nontarget Lepidoptera in different biogeographical regions (BGR) of the EU. Each BGR has its peculiarity regarding maize cultivation and the distribution of protected butterflies. The lepidopteran fauna of the Pannonian BGR is particularly sensitive due to large maize cultivation shares and wide distribution of protected butterflies within this BGR. For the BGRs evaluated potential, spatial exposures of protected butterflies to GM maize cannot be excluded. This study shows that the suggested approach is a useful tool for the consideration of EU-wide protected species in different receiving environments during the problem formulation of the ERA of GMPs. [ABSTRACT FROM AUTHOR]

Abstract Following a request from EFSA, the Panel on Plant Protection Products and their Residues developed an opinion on the science behind the risk assessment of plant protection products for in‐soil organisms. The current risk assessment scheme is reviewed, taking into account new regulatory frameworks and scientific developments. Proposals are made for specific protection goals for in‐soil organisms being key drivers for relevant ecosystem services in agricultural landscapes such as nutrient cycling, soil structure, pest control and biodiversity. Considering the time‐scales and biological processes related to the dispersal of the majority of in‐soil organisms compared to terrestrial non‐target arthropods living above soil, the Panel proposes that in‐soil environmental risk assessments are made at in‐ and off‐field scale considering field boundary levels. A new testing strategy which takes into account the relevant exposure routes for in‐soil organisms and the potential direct and indirect effects is proposed. In order to address species recovery and long‐term impacts of PPPs, the use of population models is also proposed.

Following a request from EFSA, the Panel on Plant Protection Products and their Residues developed an opinion on the science behind the risk assessment of plant protection products for in-soil organisms. The current risk assessment scheme is reviewed, taking into account new regulatory frameworks and scientific developments. Proposals are made for specific protection goals for in-soil organisms being key drivers for relevant ecosystem services in agricultural landscapes such as nutrient cycling, soil structure, pest control and biodiversity. Considering the time-scales and biological processes related to the dispersal of the majority of in-soil organisms compared to terrestrial non-target arthropods living above soil, the Panel proposes that in-soil environmental risk assessments are made at in- and off-field scale considering field boundary levels. A new testing strategy which takes into account the relevant exposure routes for in-soil organisms and the potential direct and indirect effects is proposed. In order to address species recovery and long-term impacts of PPPs, the use of population models is also proposed. [ABSTRACT FROM AUTHOR]

Abstract Maintaining a healthy environment and conserving biodiversity are major goals of environmental protection. A challenge is that protection goals outlined in legislation are often too general and broad to be directly applicable for environmental risk assessment (ERA) performed by EFSA. Therefore, they need to be translated into specific protection goals (SPGs). This Guidance presents a framework, which accounts for biodiversity and ecosystem services, to make general protection goals operational for use in all areas of EFSA's ERAs. The approach to follow has three sequential steps: (1) the identification of relevant ecosystem services; (2) the identification of service providing units (SPUs) for these ecosystem services; and (3) the specification of options for the level/parameters of protection of the SPUs using five interrelated dimensions. This last step involves the specification of options for the ecological entity and attribute to protect and the magnitude, temporal scale and spatial scale of the biologically relevant and, in the case of regulated products, tolerable effects, the latter defined in dialogue with risk managers. In order to promote transparency and consistency when developing options for the level/parameters of protection, this guidance provides considerations to justify the selected options.

The pre-market environmental risk assessment ( ERA) of regulated products such as genetically modified organisms, plant protection products and feed additives is an important process to safeguard the desired level of protection of the environment and biodiversity. ERA evaluates the potential adverse effects on the environment of certain actions, and is an important analytical scientific tool to support regulatory decision-making. Significant advances have been made in the field in recent years. Potential avenues to the further advancement of ERA of regulated products under EFSA's remit were discussed during the breakout session 'Advancing environmental risk assessment' held at the EFSA 2nd Scientific Conference 'Shaping the Future of Food Safety, Together' (Milan, Italy, 14-16 October 2015). The value of ERA and its relevance to decision-making can be increased by: (1) using the ecosystem services approach to make protection goals operational; (2) relying on problem formulation to enhance the relevance of ERA studies; (3) complying with quality standards to warrant the reliability of ERA studies; (4) making ERA more contextual by accounting for multiple stressors and environmental benefits; and (5) acknowledging the strengths and limitations of post-market environmental monitoring as a tool to resolve scientific uncertainties. [ABSTRACT FROM AUTHOR]

Maintaining a healthy environment and conserving biodiversity are major goals of environmental protection. A challenge is that protection goals outlined in legislation are often too general and broad to be directly applicable for environmental risk assessment ( ERA) performed by EFSA. Therefore, they need to be translated into specific protection goals (SPGs). This Guidance presents a framework, which accounts for biodiversity and ecosystem services, to make general protection goals operational for use in all areas of EFSA's ERAs. The approach to follow has three sequential steps: (1) the identification of relevant ecosystem services; (2) the identification of service providing units (SPUs) for these ecosystem services; and (3) the specification of options for the level/parameters of protection of the SPUs using five interrelated dimensions. This last step involves the specification of options for the ecological entity and attribute to protect and the magnitude, temporal scale and spatial scale of the biologically relevant and, in the case of regulated products, tolerable effects, the latter defined in dialogue with risk managers. In order to promote transparency and consistency when developing options for the level/parameters of protection, this guidance provides considerations to justify the selected options. [ABSTRACT FROM AUTHOR]

Abstract Following a request from the European Commission, a set of assessment criteria was developed to support the selection of existing environmental surveillance networks for post‐market environmental monitoring (PMEM) of genetically modified plants (GMPs). In compliance with these criteria, some networks and associated programmes were identified as being of potential use subject to further case‐by‐case analysis. When considering PMEM of GMPs, the approach would also require comparing sites monitored by the networks and the locations where GMPs are cultivated. The reporting of the sites surveyed by networks and locations of cultivated GMPs should thus follow the same standards in order to ensure interoperability and to potentially establish a causal link between a change observed and the GMPs. In this respect, technical support might be required by networks to transform their data records into workable standards. Moreover, the EFSA GMO Panel was asked by the European Commission to examine the sensitivity of statistical analyses used by the networks to detect change. A decision tree is provided for selecting the optimal method for statistical analysis based on the study design and the datasets from networks. Sufficient statistical power needs to be ensured to detect an effect for a particular indicator. Sample size is one of the main contributing factors in determining the power of any network to detect an effect of a product release into the environment. Increasing the sample size implies variable extra‐costs depending on whether data are collected by volunteers or professionals. A more powerful statistical analysis can also be achieved by pooling datasets collected by different networks; this needs further investigation because of important covariates leading to differentiated responses. In general, PMEM would benefit from a move towards ‘open data’ policies for re‐analysis or pooling data collected by different networks.

Following a request from the European Food Safety Authority, the Panel on Plant Protection Products and their Residues developed an opinion on the science to support the development of a risk assessment scheme of plant protection products for non-target arthropods. The current risk assessment scheme is reviewed, taking into consideration recent workshops and progress in science. Proposals are made for specific protection goals which aim to protect important ecosystem services such as food web support, pest control and biodiversity. In order to address recovery and source-sink population dynamics, conducting a landscape-level risk assessment is suggested. A new risk assessment scheme is suggested which integrates modelling approaches. The main exposure routes for non-target arthropods are identified and proposals are made on how to integrate them in the risk assessment. The appropriateness of the currently used vegetation distribution factor was investigated. It is proposed that new tests be included in order to address exposure via oral uptake of residues and uncertainties related to differences in species sensitivity. [ABSTRACT FROM AUTHOR]

Policy protection goals are set up in most countries to minimise harm to the environment, humans and animals caused by human activities. Decisions on whether to approve new agricultural products, like pesticides or genetically modified (GM) crops, take into account these policy protection goals. To support decision-making, applications for approval of commercial uses of GM crops usually comprise an environmental risk assessment (ERA). These risk assessments are analytical tools, based on science, that follow a conceptual model that includes a problem formulation step where policy protection goals are considered. However, in most countries, risk assessors face major problems in that policy protection goals set in the legislation are stated in very broad terms and are too ambiguous to be directly applicable in ERAs. This means that risk assessors often have to interpret policy protection goals without clear guidance on what effects would be considered harmful. In this paper we propose a practical approach that may help risk assessors to translate policy protection goals into unambiguous (i.e., operational) protection goals and to establish relevant assessment endpoints and risk hypotheses that can be used in ERAs. Examples are provided to show how this approach can be applied to two areas of environmental concern relevant to the ERAs of GM crops. [ABSTRACT FROM AUTHOR]

Following a request from the European Commission, a set of assessment criteria was developed to support the selection of existing environmental surveillance networks for post-market environmental monitoring (PMEM) of genetically modified plants (GMPs). In compliance with these criteria, some networks and associated programmes were identified as being of potential use subject to further case-by-case analysis. When considering PMEM of GMPs, the approach would also require comparing sites monitored by the networks and the locations where GMPs are cultivated. The reporting of the sites surveyed by networks and locations of cultivated GMPs should thus follow the same standards in order to ensure interoperability and to potentially establish a causal link between a change observed and the GMPs. In this respect, technical support might be required by networks to transform their data records into workable standards. Moreover, the EFSA GMO Panel was asked by the European Commission to examine the sensitivity of statistical analyses used by the networks to detect change. A decision tree is provided for selecting the optimal method for statistical analysis based on the study design and the datasets from networks. Sufficient statistical power needs to be ensured to detect an effect for a particular indicator. Sample size is one of the main contributing factors in determining the power of any network to detect an effect of a product release into the environment. Increasing the sample size implies variable extra-costs depending on whether data are collected by volunteers or professionals. A more powerful statistical analysis can also be achieved by pooling datasets collected by different networks; this needs further investigation because of important covariates leading to differentiated responses. In general, PMEM would benefit from a move towards 'open data' policies for re-analysis or pooling data collected by different networks. [ABSTRACT FROM AUTHOR]

ABSTRACT Latin America is anticipated to be a major growth market for agriculture and production is increasing with use of technologies such as pesticides. Reports of contamination of aquatic ecosystems by pesticides in Latin America have raised concerns about potential for adverse ecological effects. In the registration process of pesticides, all countries require significant data packages on aquatic toxicology and environmental fate. However, there are usually no specific requirements to conduct an aquatic risk assessment. To address this issue, the Society of Environmental Toxicology and Chemistry organized a workshop that brought together scientists from academia, government, and industry to review and elaborate on aquatic risk assessment frameworks that can be implemented into regulation of pesticides in Latin America. The workshop concluded that the international framework for risk assessments (protection goals, effects, and exposure assessments, risk characterization, and risk mitigation) is broadly applicable in Latin America but needs further refinement for the use in the region. Some of the challenges associated with these refinements are discussed in the article. It was recognized that there is potential for data sharing both within and outside of the region where conditions are similar. However, there is a need for research to compare local species and environmental conditions to those in other jurisdictions to be able to evaluate the applicability of data used in other countries. Development should also focus on human resources as there is a need to build local capacity and capability, and scientific collaboration and exchange between stakeholders in industry, government, and academia is also important. The meeting also emphasized that, although establishing a regionally relevant risk assessment framework is important, this also needs to be accompanied by enforcement of developed regulations and good management practices to help protect aquatic habitats. Education, training, and communication efforts are needed to achieve this. Integr Environ Assess Manag 2014;10:539-542. © 2014 SETAC [ABSTRACT FROM AUTHOR]

The Hazard Quotient (HQ) compares field application rate to intrinsic toxicity assessed with sensitive indicator species. As a hazard indicator for risk assessment, the HQ must be calibrated against measured effects under field conditions. Because protection goals may be context specific, we analyse how choice of acceptance criteria affects setting of the HQ and calibrate HQ for various scenarios under the strict condition that no false negative conclusions may be reached. We use Non-Target Arthropod toxicity data from laboratory studies on inert (Tier 1) and on natural substrates (Tier 2) and calibrate the HQ using application rates and arthropod abundance counts from field studies in orchards, arable fields, and hay meadows in 34 locations in Western Europe. With 21 formulations (17 active substances) tested in mostly multi-rate field studies, our reference data base has 120/121 values at Tier 1/Tier 2, respectively. We use the Proportion of Affected Taxa and Duration of Effect to jointly define acceptance criteria, starting with No Observed Effects. Absence of field effects is correctly predicted with HQ < 1.3 at Tier 1 and HQ < 0.48 at Tier 2, but these settings result in a high proportion of false positive outcomes. Increasing accepted duration of effect from 0 to 4 to 8 weeks results in HQ-threshold changes from 1.3 to 6.4 to 250 for Tier 1 studies and from 0.48 to 1.1 to 5.7 for Tier 2 studies. This coincides with a clear decrease in false positive outcomes. Recovery within a year is correctly concluded for 73% of the products passing the corresponding Tier 1 HQ < 2600 and for 92% of products at Tier 2 (HQ <230). Our analysis shows that the calibration is appropriate for a broad geographical range, for in-field and off-field situations and for phytophagous and non-phytophagous species alike. [Display omitted] • Hazard Quotient (field rate/LR50) calibrated against arthropod field studies. • Hazard Quotient tuned to different protection scenarios avoiding false negatives. • Hazard Quotient robust in different locations, ecological groups and habitats. • Confirmation suitability / safety for non-target arthropod sequential test schemes. [ABSTRACT FROM AUTHOR]

Genetically modified organisms (GMOs) and derived food and feed products are subject to a risk analysis and regulatory approval before they can enter the market in the European Union (EU). In this risk analysis process, the role of the European Food Safety Authority (EFSA), which was created in 2002 in response to multiple food crises, is to independently assess and provide scientific advice to risk managers on any possible risks that the use of GMOs may pose to human and animal health and the environment. EFSA's scientific advice is elaborated by its GMO Panel with the scientific support of several working groups and EFSA's GMO Unit. This review presents EFSA's scientific activities and highlights its achievements on the risk assessment of GMOs for the first 10 years of its existence. Since 2002, EFSA has issued 69 scientific opinions on genetically modified (GM) plant market registration applications, of which 62 for import and processing for food and feed uses, six for cultivation and one for the use of pollen (as or in food), and 19 scientific opinions on applications for marketing products made with GM microorganisms. Several guidelines for the risk assessment of GM plants, GM microorganisms and GM animals, as well as on specific issues such as post-market environmental monitoring (PMEM) were elaborated. EFSA also provided scientific advice upon request of the European Commission on safeguard clause and emergency measures invoked by EU Member States, annual PMEM reports, the potential risks of new biotechnology-based plant breeding techniques, evaluations of previously assessed GMOs in the light of new scientific publications, and the use of antibiotic resistance marker genes in GM plants. Future challenges relevant to the risk assessment of GMOs are discussed. EFSA's risk assessments of GMO applications ensure that data are analysed and presented in a way that facilitates scientifically sound decisions that protect human and animal health and the environment. [ABSTRACT FROM AUTHOR]

In recent years, location-based services have become very popular, mainly driven by the availability of modern mobile devices with integrated position sensors. Prominent examples are points of interest finders or geo-social networks such as Facebook Places, Qype, and Loopt. However, providing such services with private user positions may raise serious privacy concerns if these positions are not protected adequately. Therefore, location privacy concepts become mandatory to ensure the user's acceptance of location-based services. Many different concepts and approaches for the protection of location privacy have been described in the literature. These approaches differ with respect to the protected information and their effectiveness against different attacks. The goal of this paper is to assess the applicability and effectiveness of location privacy approaches systematically. We first identify different protection goals, namely personal information (user identity), spatial information (user position), and temporal information (identity/position + time). Secondly, we give an overview of basic principles and existing approaches to protect these privacy goals. In a third step, we classify possible attacks. Finally, we analyze existing approaches with respect to their protection goals and their ability to resist the introduced attacks. [ABSTRACT FROM AUTHOR]

Abstract: General protection goals for the environmental risk assessment (ERA) of plant protection products are stated in European legislation but specific protection goals (SPGs) are often not precisely defined. These are however crucial for designing appropriate risk assessment schemes. The process followed by the Panel on Plant Protection Products and their Residues (PPR) of the European Food Safety Authority (EFSA) as well as examples of resulting SPGs obtained so far for environmental risk assessment (ERA) of pesticides is presented. The ecosystem services approach was used as an overarching concept for the development of SPGs, which will likely facilitate communication with stakeholders in general and risk managers in particular. It is proposed to develop SPG options for 7 key drivers for ecosystem services (microbes, algae, non target plants (aquatic and terrestrial), aquatic invertebrates, terrestrial non target arthropods including honeybees, terrestrial non-arthropod invertebrates, and vertebrates), covering the ecosystem services that could potentially be affected by the use of pesticides. These SPGs need to be defined in 6 dimensions: biological entity, attribute, magnitude, temporal and geographical scale of the effect, and the degree of certainty that the specified level of effect will not be exceeded. In general, to ensure ecosystem services, taxa representative for the key drivers identified need to be protected at the population level. However, for some vertebrates and species that have a protection status in legislation, protection may be at the individual level. To protect the provisioning and supporting services provided by microbes it may be sufficient to protect them at the functional group level. To protect biodiversity impacts need to be assessed at least at the scale of the watershed/landscape. [Copyright &y& Elsevier]

Abstract: Agricultural practices are essential for sustaining the human population, but at the same time they can directly disrupt ecosystem functioning. Ecological risk assessment (ERA) aims to estimate possible adverse effects of human activities on ecosystems and their parts. Current ERA practices, however, incorporate very little ecology and base the risk estimates on the results of standard tests with several standard species. The main obstacles for a more ecologically relevant ERA are the lack of clear protection goals and the inherent complexity of ecosystems that is hard to approach empirically. In this paper, we argue that the ecosystem services framework offers an opportunity to define clear and ecologically relevant protection goals. At the same time, ecological models provide the tools to address ecological complexity to the degree needed to link measurement endpoints and ecosystem services, and to quantify service provision and possible adverse effects from human activities. We focus on the ecosystem services relevant for agroecosystem functioning, including pollination, biocontrol and eutrophication effects and present modeling studies relevant for quantification of each of the services. The challenges of the ecosystem services approach are discussed as well as the limitations of ecological models in the context of ERA. A broad, multi-stakeholder dialog is necessary to aid the definition of protection goals in terms of services delivered by ecosystems and their parts. The need to capture spatio-temporal dynamics and possible interactions among service providers pose challenges for ecological models as a basis for decision making. However, we argue that both fields are advancing quickly and can prove very valuable in achieving more ecologically relevant ERA. [Copyright &y& Elsevier]

Abstract: European risk managers currently face substantial difficulty in evaluating the risks of genetically modified (GM) crops for biodiversity. This difficulty is not primarily due to a lack of scientific data (the data are abundant) but rather to a lack of clear criteria for determining what represents environmental harm. Establishing criteria that define harm is not a scientific process but a process of analysing and implementing policy requirements, and policy-makers and regulatory authorities need to define what is to be regarded harmful based on existing legislation. This process is a necessary pre-condition for the environmental risk assessment of GM crops. The present paper proposes a systematic approach on how harm can be explicitly and operationally defined for decision-making. Most legal frameworks require the protection of the environment or more specifically of biodiversity from harm. It follows that the first step in defining harm should be the characterisation of protection goals; protection goals are those valued environmental resources that should not be harmed by GM crop cultivation or by any other agricultural practice. In a second step, one must derive scientifically measurable entities (so-called assessment endpoints) on the basis of the protection goals. Such endpoints are required for regulatory decision-making because they specify what deserves protection. They furthermore allow quantifiable predictions of adverse changes during environmental risk assessment. Definitions of harm also require decisions on which environmental changes should be regarded as relevant and thus represent unacceptable harm. Using a case study comparing different effects of various pest management practices, the current paper proposes an approach that differentiates between intended effects that are acceptable and harmful unintended effects. By making explicit the assumptions underlying policy choices, the ecological criteria proposed here may result in a better and more transparent evaluation of the probability of harm to biodiversity due to the cultivation of GM crops. The paper can help risk managers improve decision-making by providing methods for deriving operational decision-making criteria from policy objectives. [Copyright &y& Elsevier]

Several European directives and regulations address the environmental risk assessment of chemicals. We used the protection of freshwater ecosystems against plant protection products, biocidal products, human and veterinary pharmaceuticals, and other chemicals and priority substances under the Water Framework Directive as examples to explore the potential of ecological effect models for a refined risk assessment. Our analysis of the directives, regulations, and related guidance documents lead us to distinguish the following 5 areas for the application of ecological models in chemical risk assessment: 1) Extrapolation of organism-level effects to the population level: The protection goals are formulated in general terms, e.g., avoiding “unacceptable effects” or “adverse impact” on the environment or the “viability of exposed species.” In contrast, most of the standard ecotoxicological tests provide data only on organism-level endpoints and are thus not directly linked to the protection goals which focus on populations and communities. 2) Extrapolation of effects between different exposure profiles: Especially for plant protection products, exposure profiles can be very variable and impossible to cover in toxicological tests. 3) Extrapolation of recovery processes: As a consequence of the often short-term exposures to plant protection products, the risk assessment is based on the community recovery principle. On the other hand, assessments under the other directives assume a more or less constant exposure and are based on the ecosystem threshold principle. 4) Analysis and prediction of indirect effects: Because effects on 1 or a few taxa might have consequences on other taxa that are not directly affected by the chemical, such indirect effects on communities have to be considered. 5) Prediction of bioaccumulation within food chains: All directives take the possibility of bioaccumulation, and thus secondary poisoning within the food chain, into account. Integr Environ Assess Manag 2010;6:325–337. © 2010 SETAC [ABSTRACT FROM AUTHOR]

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Pre‐market/prospective environmental risk assessments (ERAs) contribute to risk analyses performed to facilitate decisions about the market introduction of regulated stressors. Robust ERAs begin with an explicit problem formulation, which involves among other steps: (1) formally devising plausible pathways to harm that describe how the deployment of a regulated stressor could be harmful; (2) formulating risk hypotheses about the likelihood and severity of such events; (3) identifying the information that will be useful to test the risk hypotheses; and (4) developing a plan to acquire new data for hypothesis testing should tests with existing information be insufficient for decision‐making. Here, we apply problem formulation to the assessment of possible adverse effects of RNA interference‐based insecticidal genetically modified (GM) plants, GM growth hormone coho salmon, gene drive‐modified mosquitoes and classical biological weed control agents on non‐target organisms in a prospective manner, and of neonicotinoid insecticides on bees in a retrospective manner. In addition, specific considerations for the problem formulation for the ERA of nanomaterials and for landscape‐scale population‐level ERAs are given. We argue that applying problem formulation to ERA maximises the usefulness of ERA studies for decision‐making, through an iterative process, because: (1) harm is defined explicitly from the start; (2) the construction of risk hypotheses is guided by policy rather than an exhaustive attempt to address any possible differences; (3) existing information is used effectively; (4) new data are collected with a clear purpose; (5) risk is characterised against well‐defined criteria of hypothesis corroboration or falsification; and (6) risk assessment conclusions can be communicated clearly. However, problem formulation is still often hindered by the absence of clear policy goals and decision‐making criteria (e.g. definition of protection goals and what constitutes harm) that are needed to guide the interpretation of scientific information. We therefore advocate further dialogue between risk assessors and risk managers to clarify how ERAs can address policy goals and decision‐making criteria. Ideally, this dialogue should take place for all classes of regulated stressors, as this can promote alignment and consistency on the desired level of protection and maximum tolerable impacts across regulated stressors. [ABSTRACT FROM AUTHOR]