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. Tier-3 RACs based on ecological thresholds (not considering recovery) could be derived for 18 fungicides. We show that tier-1 RACs, in the majority of cases, are more conservative than RACs calculated based on model ecosystem experiments. However, acute tier-2B RACs do not show a sufficient protection level compared with tier-3 RACs from cosm studies that tested a repeated pulsed exposure regime or when relatively persistent compounds were tested. Chronic tier-2B RACs showed a sufficient protection level, although they could only be evaluated for 6 compounds. Finally, we evaluated the suitability of the calculated RACs for 8 compounds with toxicity data for fungi. The comparison shows that the current RACs for individual fungicides, with a few exceptions (e.g., tebuconazole), show a sufficient protection level for structural and functional fungal endpoints. However, more data are needed to extend this comparison to other fungicides with different modes of action. Environ Toxicol Chem 2019:1–15.</p

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. Since published sediment toxicity data were scarce we conducted 28 d sediment-spiked toxicity test with 8 species of benthic macroinvertebrates. Ecotoxicological threshold levels for effects were assessed by applying the species sensitivity distribution approach. Based on short-term L(E)C50’s for aquatic organisms from water-only tests an acute Hazardous Concentration to 5% of the species (HC5) of 100 µg difenoconazole/L was obtained, while the HC5 based on chronic NOEC values was a factor of 104 lower (0.96 µg difenoconazole/L). For benthic macroinvertebrates the chronic HC5, based on 28d-L(E)C10 values, was 0.82 mg difenoconazole/kg dry weight sediment. To allow a risk assessment for water- and sediment-dwelling organisms, exposure concentrations were predicted for the water and sediment compartment of an edge-of-field pond bordering rice paddies treated with difenoconazole using the Chinese Top-Rice modelling approach, the Chinese Nanchang exposure scenario and the Equilibrium Partitioning theory. It appeared that in the vast majority of the 20 climate years simulated, potential risks to aquatic and sediment organisms cannot be excluded. Although the HC5 values based on laboratory toxicity data provide one line of evidence only, our evaluation suggests population- and community-level effects on these organisms due to chronic risks in particular

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. Field-collected sediment, also used in a previously performed sediment-spiked microcosm experiment, was used in tests with all species. L. variegatus and C. riparius had similar lowest 28d-L(E)C10 values when expressed in terms of total sediment concentration, but in terms of pore water concentration L. variegatus was more sensitive. Three of the six additional benthic test species (A. aquaticus, C. horaria, C. fluminalis) had 28d-EC10 values a factor of 2–6 lower than that of L. variegatus. Comparing different effect assessment tiers for sediment organisms, i.e. Tier-0 (Modified Equilibrium Partitioning approach), Tier-1 (Standard Test Species approach), Tier-2 (Species Sensitivity Distribution (SSD) approach) and Tier-3 (Model Ecosystem approach), it is concluded that the tiers based on sediment-spiked laboratory toxicity tests provide sufficient protection when compared with the Tier-3 Regulatory Acceptable Concentration (RAC). Differences between Tier-1 and Tier-2 RACs, however, appear to be relatively small and not always consistent, irrespective of expressing the RAC in terms of total sediment or pore water concentration. Derivation of RACs by means of the SSD approach may be a challenge, because it is difficult obtaining a sufficient number of valid chronic EC10 values with appropriate 95% confidence bands for sediment-dwelling macroinvertebrates. Therefore, this paper proposes a Tier-2 Weight-of-Evidence approach to be used in case an insufficient number of valid additional toxicity data is made available. Similar studies with pesticides that differ in fate properties and toxic mode-of-action are necessary for further validation of the tiered effect assessment approach for sediment organisms.</p

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. To assess the potential environmental effects of fludioxonil in the sediment compartment of edge-of-field surface waters, sediment-spiked single-species toxicity tests with benthic macroinvertebrates were performed. In all experiments artificial sediment was used with an organic carbon content of 2.43% on dry weight basis. The single-species tests were conducted with 8 benthic macroinvertebrates covering different taxonomic groups typical for the Yangtze River Delta, China. The 28d-EC10 and 28-LC10 values thus obtained were used to construct species sensitivity distributions (SSDs). In addition, our dataset was supplemented with 28d-EC10 and 28-LC10 values for 8 different benthic invertebrates from a study in the Netherlands that used field-collected sediment. Based on SSDs constructed with 28d-EC10 or 28d-LC10 values hazardous concentrations to 5% of the species tested (HC5’s) were obtained. The HC5 values based on the toxicity tests from China were lower than those from the Netherlands, although 95% confidence bands overlapped. The HC5 values derived from the separate datasets from China and the Netherlands, as well as from the combined dataset, were compared to the Tier-3 Regulatory Acceptable Concentrations (RAC) for fludioxonil and the benthic invertebrate community derived from a sediment-spiked outdoor microcosm experiment conducted in the Netherlands. The HC5 values obtained appeared to be lower than this Tier-3 RAC when expressed in terms of total sediment concentration, but not always when expressed in terms of pore water concentrations

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. Toxicokinetic-toxicodynamic (TKTD)models can be used to extrapolate the toxic effects of a chemical to a specific, time-variable exposure regime. The aim of this paper was to develop Exposure Pattern Specific SSDs (EPS-SSDs)for three insecticides using TKTD models and to compare the HC5 of different exposure patterns with the same time-weighted average concentration to evaluate whether the use of EPS-SSDs would change the outcome of the ecological risk assessment. The EPS-SSDs were developed by estimating TKTD parameters for the compounds chlorpyrifos, imidacloprid and lambda-cyhalothrin using results from standard, 96 h, single species tests. These parameter estimates were used for TKTD modelling to determine toxicity thresholds (e.g. LC10 and LC50)for contrasting exposure patterns after certain evaluation times (4, 10 or 100 days). HC5 values were constructed with TKTD-predicted LC10- and LC50- values for different exposure patterns characterised by similar time-weighted average concentrations. Differences between those HC5 values ranged from a factor 1 to a factor 2.3 for the short evaluation period (4 d). This difference was smaller when using an evaluation period of 10 days instead of 4 days and selecting the TKTD-predicted LC10 instead of TKTD-predicted LC50 based HC5s. For the long term evaluation period (100 d), a maximum difference of a factor of 30 was found.</p

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. the ecological recovery, may depend on various factors related to the affected taxon, the ecosystem of concern and the type of stressor with consequences for the assessment and management of risks associated with chemical contaminants. Whereas the effects caused by short-term exposure might be acceptable to some extent, the conditions under which ecological recovery can serve as a decision criterion in the environmental risk assessment of chemical stressors remains to be evaluated. For a generic consideration of recovery in the risk assessment of chemicals, we reviewed case studies of natural and artificial aquatic systems and evaluate five aspects that might cause variability in population recovery time: (1) taxonomic differences and life-history variability, (2) factors related to ecosystem type and community processes, (3) type of disturbance, (4) comparison of field and semi-field studies, and (5) effect magnitude, i.e., the decline in population size following disturbance. We discuss our findings with regard to both retrospective assessments and prospective risk assessment

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

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 (1.7–614 mg a.s./kg dry sediment) based around the reported 28-d No Observed Effect Concentration (NOEC) for Chironomus riparius (40 mg a.s./kg dry sediment). Twelve systems were available per treatment of which four were sacrificed on each of days 28, 56 and 84 after microcosm construction. Fludioxonil persisted in the sediment and mean measured concentrations were 53–82% of the initial concentration after 84 days. The dissipation rate increased with the treatment level. Also exposure concentrations in overlying water were long-term, with highest concentrations 28 days after initiation of the experiment. Sediment-dwelling Oligochaeta and pelagic Rotifera and Cladocera showed the most pronounced treatment-related declines. The most sensitive sediment-dwelling oligochaete was Dero digitata (population NOEC 14.2 mg a.s./kg dry sediment). The same NOEC was calculated for the sediment-dwelling macroinvertebrate community. The most sensitive zooplankton species was the cladoceran Diaphanosoma brachyurum (NOEC of 1.6 μg a.s./L in overlying water corresponding to 5.0 mg a.s./kg dry sediment). At the two highest treatments several rotifer taxa showed a pronounced decrease, while the zooplankton community-level NOEC was 5.6 μg a.s./L (corresponding to 14.2 mg a.s./kg dry sediment). Zooplankton taxa calanoid Copepoda and Daphnia gr. longispina showed a pronounced treatment-related increase (indirect effects). Consequently, an assessment factor of 10 to the chronic laboratory NOECs of Chironomus riparius (sediment) and Daphnia magna (water) results in a regulatory acceptable concentration that is sufficiently protective for both the sediment-dwelling and pelagic organisms in the microcosms.</p