1.21 Improving pesticide regulation by use of impact analyses: A case study for bees

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.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

4.11 Non-Apis (Bombus terrestris) versus honeybee (Apis mellifera) acute oral and contact sensitivity – Preliminary results of ECPA company data evaluation

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 LD 50 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.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 LD 50 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

Evaluation of honey bee larvae data: sensitivity to PPPs and impact analysis of EFSA Bee GD

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.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

1.16 Sensitivity of honey bee larvae to plant protection products and impact of EFSA bee guidance document

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 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

Examining the reproducibility of meta-analyses in psychology:A preliminary report

Meta-analyses are an important tool to evaluate the literature. It is essential that meta-analyses can easily be reproduced to allow researchers to evaluate the impact of subjective choices on meta-analytic effect sizes, but also to update meta-analyses as new data comes in, or as novel statistical techniques (for example to correct for publication bias) are developed. Research in medicine has revealed meta-analyses often cannot be reproduced. In this project, we examined the reproducibility of meta-analyses in psychology by reproducing twenty published meta-analyses. Reproducing published meta-analyses was surprisingly difficult. 96% of meta-analyses published in 2013-2014 did not adhere to reporting guidelines. A third of these meta-analyses did not contain a table specifying all individual effect sizes. Five of the 20 randomly selected meta-analyses we attempted to reproduce could not be reproduced at all due to lack of access to raw data, no details about the effect sizes extracted from each study, or a lack of information about how effect sizes were coded. In the remaining meta-analyses, differences between the reported and reproduced effect size or sample size were common. We discuss a range of possible improvements, such as more clearly indicating which data were used to calculate an effect size, specifying all individual effect sizes, adding detailed information about equations that are used, and how multiple effect size estimates from the same study are combined, but also sharing raw data retrieved from original authors, or unpublished research reports. This project clearly illustrates there is a lot of room for improvement when it comes to the transparency and reproducibility of published meta-analyses

Daily Experiences of Direct Contact and Media Contact

The present research examined how daily experiences of intergroup contact through social interaction (direct contact) and exposure to outgroups in media (media contact) facilitate improvements in intergroup attitudes. A longitudinal diary study was conducted whereby participants indicated the amount of direct contact and media contact they had each day, as well as their intergroup attitudes. Results indicated that direct contact and media contact both independently predicted improvements in intergroup attitudes. For direct contact, but not media contact, this relationship was moderated by the perceived negativity of the contact. Time-lagged analyses indicated that direct contact on a given day predicted improved intergroup attitudes on a subsequent day above and beyond direct contact on that day, but that media contact has little or no residual impact. This suggests that although media contact and direct contact may both be effective at promoting more positive intergroup attitudes, direct contact may have a more lasting impact.MAS