Aquatic and sediment ecotoxicity data of difenoconazole and its potential environmental risks in ponds bordering rice paddies.

Difenoconazole has a widespread agricultural use to control fungal diseases in crops, including rice. In edge-of-field surface waters the residues of this lipophilic fungicide may be toxic to both pelagic and benthic organisms. To allow an effect assessment we mined the regulatory and open literature for aquatic toxicity data.

Species Sensitivity Distributions of Benthic Macroinvertebrates in Fludioxonil-Spiked Sediment Toxicity Tests.

The fungicide fludioxonil, given its physicochemical properties, potentially accumulates and persists in sediments. Fludioxonil has a widespread agricultural use to control various fungal diseases. Its residues may cause toxic effects to benthic aquatic fauna, thereby impacting ecosystem service functions of aquatic ecosystems.

Open Science in regulatory environmental risk assessment.

A possible way to alleviate the public skepticism toward regulatory science is to increase transparency by making all data and value judgments used in regulatory decision making accessible for public interpretation, ideally early on in the process, and following the concepts of Open Science. This paper discusses the opportunities and challenges in strengthening Open Science initiatives in regulatory environmental risk assessment (ERA). In this discussion paper, we argue that the benefits associated with Open Science in regulatory ERA far outweigh its perceived risks.

Application of General Unified Threshold Models of Survival Models for Regulatory Aquatic Pesticide Risk Assessment Illustrated with an Example for the Insecticide Chlorpyrifos.

Mathematical models within the General Unified Threshold models of Survival (GUTS) framework translate time-variable chemical exposure information into expected survival of animals. The GUTS models are species and compound specific and explicitly describe the internal exposure dynamics in an organism (toxicokinetics) and the related damage and effect dynamics (toxicodynamics), thereby connecting the external exposure concentration dynamics with the simulated mortality or immobility over time. In a recent scientific opinion on toxicokinetic-toxicodynamic (TKTD) models published by the European Food Safety Authority (EFSA), the GUTS modeling framework was considered ready for use in the aquatic risk assessment for pesticides and aquatic fauna.

Sediment toxicity of the fungicide fludioxonil to benthic macroinvertebrates -evaluation of the tiered effect assessment procedure.

28-Day sediment-spiked laboratory toxicity tests with eight benthic macroinvertebrates and the lipophilic fungicide fludioxonil were conducted to verify the proposed tiered sediment effect assessment procedure as recommended by the European Food Safety Authority (EFSA). The test species were the oligochaetes Lumbriculus variegatus and Tubifex tubifex, the insects Chironomus riparius and Caenis horaria, the crustaceans Hyalella azteca and Asellus aquaticus and the bivalves Corbicula fluminalis and Pisidium amnicum. Toxicity estimates were expressed in terms of total concentration of dry sediment as well as in pore water concentration.

Is the Effect Assessment Approach for Fungicides as Laid Down in the European Food Safety Authority Aquatic Guidance Document Sufficiently Protective for Freshwater Ecosystems?

In Europe, the European Food Safety Authority aquatic guidance document describes the procedures for the derivation of regulatory acceptable concentrations (RACs) for pesticides in edge-of-field surface waters on the basis of tier-1 (standard test species), tier-2 (geometric mean and species sensitivity distributions [SSDs]), and tier-3 (model ecosystem studies) approaches. In the present study, the protectiveness of such a tiered approach was evaluated for fungicides. Acute and chronic RACs for tier-1 and tier-2B (SSDs) were calculated using toxicity data for standard and additional test species, respectively.

Exposure pattern-specific species sensitivity distributions for the ecological risk assessments of insecticides.

In the higher tiers of pesticide risk assessment, the Species Sensitivity Distribution (SSD) concept is often used to establish the effect threshold defined as the concentration protecting 95% of the species (Hazardous Concentration 5%, HC5). The toxicity data included in SSDs are normally established using a constant exposure regime. However, the exposure of pesticides in the field is often characterised by a variable exposure regime.

Guidance on the assessment of the safety of feed additives for the environment.

This guidance document is intended to assist the applicant in the preparation and the presentation of an application, as foreseen in Article 7.6 of Regulation (EC) No 1831/2003, for the authorisation of additives used in animal nutrition. It specifically covers the assessment of the safety for the environment.

Ecological Recovery and Resilience in Environmental Risk Assessments at the European Food Safety Authority.

A conceptual framework was developed by a working group of the Scientific Committee of the European Food Safety Authority (EFSA) to guide risk assessors and risk managers on when and how to integrate ecological recovery and resilience assessments into environmental risk assessments (ERA). In this commentary we advocate that a systems approach is required to integrate the diversity of ecosystem services (ES) providing units, environmental factors, scales, and stressor-related responses necessary to address the context dependency of recovery and resilience in agricultural landscapes. A future challenge in the resilience assessment remains to identify the relevant bundles of ecosystem services provided by different types of agroecosystem that need to be assessed in concert.

Exposure and effects of sediment-spiked fludioxonil on macroinvertebrates and zooplankton in outdoor aquatic microcosms.

Information from effects of pesticides in sediments at an ecosystem level, to validate current and proposed risk assessment procedures, is scarce. A sediment-spiked outdoor freshwater microcosm experiment was conducted with fludioxonil (lipophilic, non-systemic fungicide) to study exposure dynamics and treatment-related responses of benthic and pelagic macroinvertebrates and zooplankton. Besides blank control and solvent control systems the experiment had six different treatment levels (1.

Scientific motivations and criteria to consider updating EFSA scientific assessments.

EFSA is committed to assess and communicate the risks occurring in the food and feed chain from farm to fork and to provide other forms of scientific advice. This work, carried out by EFSA since its inception, has resulted in the adoption of thousands of scientific assessments. EFSA is obliged to re-assess past assessments in specific regulatory contexts such as those on food and feed additives, active substances in plant protection products and genetically modified food and feed.

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.

Prospective Environmental Risk Assessment for Sediment-Bound Organic Chemicals: A Proposal for Tiered Effect Assessment.

A broadly accepted framework for prospective environmental risk assessment (ERA) of sediment-bound organic chemicals is currently lacking. Such a framework requires clear protection goals, evidence-based concepts that link exposure to effects and a transparent tiered-effect assessment. In this paper, we provide a tiered prospective sediment ERA procedure for organic chemicals in sediment, with a focus on the applicable European regulations and the underlying data requirements.

Is the chronic Tier-1 effect assessment approach for insecticides protective for aquatic ecosystems?

We investigated the appropriateness of several methods, including those recommended in the Aquatic Guidance Document of the European Food Safety Authority (EFSA), for the derivation of chronic Tier-1 regulatory acceptable concentrations (RACs) for insecticides and aquatic organisms. The insecticides represented different chemical classes (organophosphates, pyrethroids, benzoylureas, insect growth regulators, biopesticides, carbamates, neonicotinoids, and miscellaneous). Chronic Tier-1 RACs derived using toxicity data for the standard species Daphnia magna, Chironomus spp.

Developing ecological scenarios for the prospective aquatic risk assessment of pesticides.

The prospective aquatic environmental risk assessment (ERA) of pesticides is generally based on the comparison of predicted environmental concentrations in edge-of-field surface waters with regulatory acceptable concentrations derived from laboratory and/or model ecosystem experiments with aquatic organisms. New improvements in mechanistic effect modeling have allowed a better characterization of the ecological risks of pesticides through the incorporation of biological trait information and landscape parameters to assess individual, population and/or community-level effects and recovery. Similarly to exposure models, ecological models require scenarios that describe the environmental context in which they are applied.

Ecological Recovery Potential of Freshwater Organisms: Consequences for Environmental Risk Assessment of Chemicals.

Chemical contaminants released into the in the environment may have adverse effects on (non-target) species, populations and communities. The return of a stressed system to its pre-disturbance or other reference state, i.e.

How TK-TD and population models for aquatic macrophytes could support the risk assessment for plant protection products.

This case study of the Society of Environmental Toxicology and Chemistry (SETAC) workshop MODELINK demonstrates the potential use of mechanistic effects models for macrophytes to extrapolate from effects of a plant protection product observed in laboratory tests to effects resulting from dynamic exposure on macrophyte populations in edge-of-field water bodies. A standard European Union (EU) risk assessment for an example herbicide based on macrophyte laboratory tests indicated risks for several exposure scenarios. Three of these scenarios are further analyzed using effect models for 2 aquatic macrophytes, the free-floating standard test species Lemna sp.

Analysing chemical-induced changes in macroinvertebrate communities in aquatic mesocosm experiments: a comparison of methods.

Mesocosm experiments that study the ecological impact of chemicals are often analysed using the multivariate method 'Principal Response Curves' (PRCs). Recently, the extension of generalised linear models (GLMs) to multivariate data was introduced as a tool to analyse community data in ecology. Moreover, data aggregation techniques that can be analysed with univariate statistics have been proposed.

Acute tier-1 and tier-2 effect assessment approaches in the EFSA Aquatic Guidance Document: are they sufficiently protective for insecticides?

Background: The objective of this paper is to evaluate whether the acute tier-1 and tier-2 methods as proposed by the Aquatic Guidance Document recently published by the European Food Safety Authority (EFSA) are appropriate for deriving regulatory acceptable concentrations (RACs) for insecticides. The tier-1 and tier-2 RACs were compared with RACs based on threshold concentrations from micro/mesocosm studies (ETO-RAC). A lower-tier RAC was considered as sufficiently protective, if less than the corresponding ETO-RAC.

Impact of imidacloprid on life-cycle development of Coccinella septempunctata in laboratory microcosms.

Long-term effects of a single application of imidacloprid on ladybird beetle, Coccinella septempunctata L., were studied in indoor laboratory microcosms, starting with the 2nd instar larvae of C. septempunctata but covering the full life cycle.

Assessing effects of the fungicide tebuconazole to heterotrophic microbes in aquatic microcosms.

Aquatic ecological risk assessment of fungicides in Europe under Regulation 1107/2009/EC does not currently assess risk to non-target bacteria and fungi. Rather, regulatory acceptable concentrations based on ecotoxicological data obtained from studies with fish, invertebrates and primary producers (including algae) are assumed to be protective to all other aquatic organisms. Here we explore the validity of this assumption by investigating the effects of a fungicide (tebuconazole) applied at its "non-microbial" HC5 concentration (the concentration that is hazardous to 5% of the tested taxa) and derived from acute single species toxicity tests on fish, invertebrates and primary producers (including algae) on the community structure and functioning of heterotrophic microbes (bacteria and aquatic fungi) in a semi-field study, using novel molecular techniques.

A simulation study on effects of exposure to a combination of pesticides used in an orchard and tuber crop on the recovery time of a vulnerable aquatic invertebrate.

The aim of the present study was to assess whether population effects and recovery times increase when a population of a vulnerable aquatic invertebrate is exposed to concentrations of 1 or multiple pesticides. The 2 sets of pesticide combinations tested are typical for orchard and tuber crops in The Netherlands. Exposure concentrations were predicted using the FOCUS step 3 modeling framework and the Dutch drainage ditch scenario.

Toxic effects of hexaflumuron on the development of Coccinella septempunctata.

Studying the toxic risk of pesticide exposure to ladybird beetles is important from an agronomical and ecological perspective since larval and adult ladybirds are dominant predators of herbivorous pest insects (e.g., aphids) in various crops in China.