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.

The concept of source‐sink dynamics as a potentially important component of metapopulation dynamics was introduced in the 1980s. The objective of the present review was to review the considerable body of work that has been developed, to consider its theoretical implications as well as to understand how source‐sink dynamics may manifest under field conditions in the specific case of nontarget arthropods in the agricultural environment. Our review concludes that metapopulation dynamics based on field observations are often far more complex than existing theoretical source‐sink models would indicate, because they are dependent on numerous population processes and influencing factors. The difficulty in identifying and measuring these factors likely explains why empirical studies assessing source‐sink dynamics are scarce. Furthermore, we highlight the importance of considering the spatial and temporal heterogeneity of agricultural landscapes when assessing the population dynamics of nontarget arthropods in the context of the risk from the use of plant protection products. A need is identified to further develop and thoroughly validate predictive population models, which can incorporate all factors relevant to a specific system. Once reliable predictive models for a number of representative nontarget arthropod species are available, they could provide a meaningful tool for refined risk evaluations (higher tier level risk assessment), addressing specific concerns identified at the initial evaluation stages (lower tier level risk assessment). Environ Toxicol Chem 2021;40:2667–2679. © 2021 ERM, FMC, Syngenta, Bayer AG, BASF SE, Corteva agriscience. Environmental Toxicology and Chemistry published by Wiley Periodicals LLC on behalf of SETAC.

The aim of the study was to investigate the potential impact of the insecticide chlorantraniliprole on queen-right bumblebee ( Bombus terrestris ) colonies under semi-field conditions in Phacelia tanacetifolia . The P. tanacetifolia crop was grown in soil treated with modelled worst-case 20-year plateau concentration of chlorantraniliprole in the top 20 cm of soil (equivalent to 0.088 mg a.s./kg). Additionally, two chlorantraniliprole spray applications at 60 g a.s./ha were made. In treatment T1 both spray applications took place before P. tanacetifolia flowering at growth stages BBCH 51–55 and BBCH 55–59. In T2 one spray application was conducted before P. tanacetifolia flowering at BBCH 55–59 and one application during P. tanacetifolia flowering and during daily bee flight at BBCH 61–62. The application in the control (C) and reference item treatment (R) (400 g dimethoate a.s./ha) was carried out during full P. tanacetifolia flowering and bumblebee flight. The bumblebee colonies were exposed to the treated flowering P. tanacetifolia crop for 20 days in the tunnels and afterwards the colonies were kept on a monitoring site. Results of this study indicate no significant differences between the chlorantraniliprole groups T1 and T2 and the control regarding all parameters assessed (i.e. adult and larval mortality, flight activity at the hive entrance, colony weight development, condition of the colonies and production of young queens and males). Overall, no effects of chlorantraniliprole on B. terrestris colonies including queen/male production, adult and larval survival, colony development and forager flight activity were found in this worst-case exposure set-up.

The ICPPR Semi-Field/Field Testing (SF/FT) workgroup consists of several ‘writing groups’ that are focused developing technical guidance that is focused on 4 separate but related topics: 1) designing and conducting pollen and nectar residue studies, 2) conducting large scale colony feeding studies, 3) updating guidance for conducting semi-field tunnel studies, and 4) design and interpretation of full field studies with bees. What follows is the current status of each of these activities.

In addition to other assessments, the EFSA bee guidance document (2013) requires the risk assessment of plant protection products on honey bee larvae. At the time the EFSA GD was finalized, no data on honey bee larvae were available due to absence of suitable methods. That is why in 2013 the European Crop Protection Association (ECPA) perfomed an impact analysis of the new EFSA risk assessment, using extrapolated endpoints derived from acute oral honey bee endpoints. Today, a number of honey bee larvae toxicity studies (138 active substances or formulated products) have been conducted according to the newly developed testing methods for single exposure (OECD TG 237) repeated exposure studies until the end of the larval development (D7/D8) and repeated exposure testing (OECD GD 239) until adult hatch (D22). These experimental data have been used to determine the ‘pass rates’ for 215 worst case uses (72 fungicide spray and solid uses, 91 herbicide spray uses, incl. 8 PGR uses and in total 52 insecticide spray and solid uses, incl. 2 nematicide and 3 IGR uses) according to the EFSA Bee GD and to compare with the original ECPA impact analysis. As standardized test methods for non- Apis bees larvae were not available, risk assessment according to EFSA for bumblebees and solitary bees based on the honey bee endpoint as surrogate corrected by a safety factor of 10. Morevoer, the sensitivity of the NOEDs at D8 and D22 in repeated exposure (D 22) studies were analysed. Overall, the toxicity of fungicides and herbicides to honey bee larvae (expressed as means and medians of NOED and LD50 values) was moderate to low, while insecticides as expected displayed stronger toxicity. Moreover, the endpoints for herbicides were on average a factor of 2 higher than fungicides which ranges within the normal biological variability (factor of 3). In addition, it is unclear, if the difference is related to a slightly higher toxicity or other factors like different physical chemical properties (e.g. lower solubility). For insecticides, toxicity was about 125 (based on medians) and 6 to 8 (based on means) times higher than herbicides. In the screening risk assessment according to EFSA Bee GD the majority of fungicide (83.3%) and herbicide (95.6%) uses passed the risk assessment for larvae; whereas, for all insecticide uses thr pass rate was about 29%. In the Tier 1 risk assessment, these pass rates slightly increased and were even higher in the ‘treated crop’ and ‘weed in the field’ scenarios for fungicide and herbicide uses, almost being 100%. Pass rates for insecticide uses did not improve very much and amounted to be about 42% for both scenarios. When basing the risk assessment of bumblebee and solitary bee larvae on 1/10th of the honey bee larval endpoint, the majority of active substances and their respective products will fail the screening (overall about 96%) and Tier 1 risk assessment (overall about 90%). Alternative risk assessment approaches proposed by ECPA (e.g. following the EPPO approach; ECPA Option 1 using refinement options and more representative assumptions) or comparing an assummed exposure concentration to the NOEC (ECPA Option 2) led to a slight increase (Option 1) or even no differences in the pass rates (Option 2a) compared to EFSA Tier 1 risk assessment. Thus both, the standard risk assessment according to the EFSA Bee GD as well as the alternative ECPA Option 1 and 2 result in a clear distinction between products with high toxicity (insecticides) vs. non-toxic products (herbicides and fungicides) for the honey bee risk assessment. The sensitivity analysis of repeated exposure studies according OECD GD 239 indicated that in most cases toxicity did not increase during the pupation period between D8 and D22. Thus, the larval growing period between D3 and D8 represents the most sensitive period of the pre-imaginal development.

The study investigated the potential impact of the insecticide chlorantraniliprole (Coragen® brand) on the bumble bee (Bombus terrestris L.) under semi-field conditions in Phacelia tanacetifolia in Germany based on ringtest protocols from the ICPPR Non-Apis workshops (2016 and 2017). The P. tanacetifolia crop was grown in soil treated with the predicted 20-year plateau concentration of chlorantraniliprole in the top 20 cm of soil (equivalent to a predicted 20-year plateau concentration of 0.088 mg a.s./kg). Additionally, two chlorantraniliprole applications at 60 g a.s./ha were made in the chlorantraniliprole treatments (T1 and T2). In T1 both applications took place before P. tanacetifolia flowering at BBCH 51-55 and BBCH 55-59. In T2 one application was conducted before P. tanacetifolia flowering at BBCH 55-59 and one application during P. tanacetifolia flowering and during daily bee flight at BBCH 61-62. The application in the control (C) and reference item treatment (R) (400 g dimethoate a.s./ha) was carried out during full P. tanacetifolia flowering and bumble bee flight. The bumble bee colonies were exposed to the treated flowering P. tanacetifolia crop for 20 days in the tunnels and afterwards the colonies were kept on a monitoring site. The results of this study indicate no significant differences between the chlorantraniliprole treatment groups T1 and T2 and the control regarding all parameters assessed (i.e. mortality in the colonies and in the tunnels, flight activity at the hive entrance, hive weight development, condition of the colonies and production of young queens and males). Overall, no effects of chlorantraniliprole on bumble bee B. terrestris colonies including queen/male production, adult and larval survival and forager flight activity were found.

When changes to regulatory guidance for risk assessment are proposed it is necessary to undertake an impact analysis to assess whether they bring the desired improvement to a risk assessment and reliability of the outcomes to inform decision making. In particular impact analyses should estimate the chances of getting both false negative (concluding low risk where more research is needed) and false positive outcomes (concluding high risks where the product is of low risk). Such analyses are also used to inform on future product development costs and workload for regulatory authorities. In this paper, we present the findings from an impact analysis conducted on the proposed EFSA bee guidance document (2013) and discuss whether the proposed guidance would provide for a cost effective and tiered approach toward the protection of bees due to the potential risks posed by the use of plant protection products. Following on from this a second impact assessment is presented based on new data generated by ECPA member companies regarding the assessment of chronic risk to bees. Critical areas are discussed and suggestions for the improvement of assess the risk assessment for plant protection products (PPP) to bees are presented.

A preliminary data evaluation was conducted by ECPA companies to compare the sensitivity of bumblebees (Bombus terrestris) with the sensitivity of honeybees (Apis mellifera). For the evaluation about 70 data sets were available for contact exposure and about 50 data sets for oral exposure. The data sets comprised insecticides, fungicides, herbicides in about equal numbers plus a few other substances. The preliminary ECPA company data evaluation of LD50 values indicates lower or similar contact sensitivity of bumblebees vs. honeybees. Similarly, lower or similar oral sensitivity of bumblebees vs. honeybees was determined with one exception for an insecticide that indicated higher acute oral bumblebee sensitivity compared to honeybees. For this insecticide, higher tier data indicates no negative impact on bumblebees at the maximum intended use rate. Overall, the ECPA company data evaluation indicates that bumblebees are not more sensitive than honeybees based on acute toxicity assessment.

In addition to other assessments, the 2013 EFSA bee guidance document requires the risk assessment of plant protection products on honey bee larvae. At the time the EFSA document was finalized, no data on honey bee larvae were available. In 2013 ECPA (the European Crop Protection Association) perfomed an impact analysis of the (then) new EFSA risk assessment and the reliability of the outcomes, using estimated endpoints derived from acute oral honey bee tests together with the usual extrapolation factors. Today, a number of honey bee larvae toxicity studies have been conducted according to the newly developed testing methods for single exposure (OECD TG 237) and repeated exposure testing (OECD GD 239). These experimental data have been used to update the ECPA impact analysis. Data on 114 active substances or formulated products were used, covering 166 worst case uses; (58 herbicides, 53 fungicides, 47 insecticides and 8 PGRs). The "pass" rates were determined according to the EFSA Bee guidance document and compared with the original outcome of the impact analysis from 2013 and with adult chronic toxicity data. When the findings of the impact analysis based on experimental data from 22 day larval tests was compared with the impact analysis from 2013 based on extrapolated data the two gave very similar results, thus indicating that the original assessment using acute data and extrapolation factors was suitably predictive.

In the first step of earthworm risk assessment for plant protection products (PPPs), the risk is assessed by comparing the no-observed effect levels (NOELs) from laboratory reproduction tests with the predicted exposure of the PPP in soil, while applying a trigger value (assessment factor [AF]) to cover uncertainties. If this step indicates a potential risk, field studies are conducted. However, the predicted environmental concentration in soil, which can be calculated, for example, for different soil layers (ranging from 0-1cmto 0-20 cm), and the AF determine the conservatism that is applied in this first step. In this review paper, the tier 1 earthworm risk assessment for PPPs is calibrated by comparing the NOEL in earthworm reproduction tests with effect levels on earthworm populations under realistic field conditions. A data set of 54 pairs of studies conducted in the laboratory and in the field with the same PPP was compiled, allowing a direct comparison of relevant endpoints. The results indicate that a tier 1 AF of 5 combined with a regulatory relevant soil layer of 0 to 5cm provides a conservative tier 1 risk assessment. A risk was identified by the tier 1 risk assessment in the majority of the cases at application rates that were of low risk for natural earthworm populations under field conditions. Increasing the conservatism in the tier 1 risk assessment by reducing the depth of the regulatory relevant soil layer or by increasing the tier 1 AF would increase the number of false positives and trigger a large number of additional field studies. This increased conservatism, however, would not increase the margin of safety for earthworm populations. The analysis revealed that the risk assessment is conservative if an AF of 5 and a regulatory relevant soil layer of 0 to 5cm is used. (C) 2015 SETAC

Cyantraniliprole is the second active ingredient in the anthranilic diamide insecticide class (IRAC Group 28; next to chlorantraniliprole) and the first to control a cross-spectrum of chewing and sucking pests. Cyantraniliprole is a systemic insecticide and mobile via xylem. Oilseed rape seed treatment with cyantraniliprole 625 g/L FS (Lumiposa) at 50 μg a.s./seed provides excellent control of against pests like flea beetles in young emerging rape. The Lumiposa seed treatment product is registered for use in rape in USA and Canada. Cyantraniliprole is characterized by low water solubility (about 0.01 g/L). No increased honeybee mortality was determined in the oral acute toxicity test at maximum water solubility level of cyantraniliprole indicating a low risk potential for bees via systemic plant exposure routes. Also, cyantraniliprole shows rapid decline in soil with DT50 soil values ranging between 13-87 days with no potential for accumulation in soil from repeated uses according to cyantraniliprole labels. Cyantraniliprole residue can be found in guttation droplets of young emerging rape plants, but the cyantraniliprole concentrations in guttation droplets show a rapid decline. No residues of cyantraniliprole metabolites were detected in any rape guttation liquid samples. Worst-case oral risk assessments indicate low risk for bees resulting from the potential cyantraniliprole uptake via guttation liquid. Cyantraniliprole residues or residues of plant metabolites were not detected in pollen or nectar of flowering summer or winter rape or in bee matrices like honey or wax. Honeybee colonies exposed next to flowering winter oilseed rape seed-treated with Lumiposa and honeybee colonies exposed to control field in Germany and France confirmed the safe use of Lumiposa and lack of any effects on honeybee colonies. Based on the available data for cyantraniliprole and its metabolites it is unlikely that the intended use of Lumiposa as oilseed rape seed treatment will have any unacceptable inand off-crop effects on bees resulting from systemic exposure (guttation droplets, nectar or pollen) or from dust drift during drilling.

Background: The pollinator profile of cyantraniliprole, a systemic anthranilic diamide insecticide, with foliar or soil applications between 12.5 to 150 g a.s./ha, was investigated. Results: Cyantraniliprole - tested up to maximum water solubility level caused no increased acute oral or contact honeybee mortality. The lowest LD50 values for formulated cyantraniliprole were 0.39 (oral) and 0.63 (contact) g cyantraniliprole/honeybee, respectively. The oral toxicity of 4 plant metabolites was maximally similar to cyantraniliprole or no oral toxicity was determined up to maximal water solubility level. Cyantraniliprole spray deposits at 150 g a.s./ha and aged for 3 hours pose low risk for honeybees. Cyantraniliprole use may results in residues in pollen and nectar, but oral honeybee risk assessments indicate low risk for honeybees via oral exposure. In semi-field and field honeybee tests low risk for honeybees was confirmed. Tomato greenhouse study results demonstrate that there is an excellent fit between the use of bumblebees (Bombus terrestris) for pollination and cyantraniliprole applied either via spray or drip irrigation. Conclusion: Based on a comprehensive data package it was found that the intended uses of DuPont cyantraniliprole formulations pose low risk for pollinators.