Intermediate-tier options in the environmental risk assessment of plant protection products for soil invertebrates-Synthesis of a workshop.

The European environmental risk assessment (ERA) of plant protection products follows a tiered approach. The approach for soil invertebrates currently consists of two steps, starting with a Tier 1 assessment based on reproduction toxicity tests with earthworms, springtails, and predatory mites. In case an unacceptable risk is identified at Tier 1, field studies can be conducted as a higher-tier option. For soil invertebrates, intermediate tiers are not implemented. Hence, there is limited possibility to include additional information for the ERA to address specific concerns when the Tier 1 fails, as an alternative to, for example, a field study. Calibrated intermediate-tier approaches could help to address risks for soil invertebrates with less time and resources but also with sufficient certainty. A multistakeholder workshop was held on 2-4 March 2022 to discuss potential intermediate-tier options, focusing on four possible areas: (1) natural soil testing, (2) single-species tests (other than standard species), (3) assessing recovery in laboratory tests, and (4) the use of assembled soil multispecies test systems. The participants acknowledged a large potential in the intermediate-tier options but concluded that some issues need to be clarified before routine application of these approaches in the ERA is possible, that is, sensitivity, reproducibility, reliability, and standardization of potential new test systems. The definition of suitable assessment factors needed to calibrate the approaches to the protection goals was acknowledged. The aims of the workshop were to foster scientific exchange and a data-driven dialog, to discuss how the different approaches could be used in the risk assessment, and to identify research priorities for future work to address uncertainties and strengthen the tiered approach in the ERA for soil invertebrates. This article outlines the background, proposed methods, technical challenges, difficulties and opportunities in the ERA, and conclusions of the workshop. Integr Environ Assess Manag 2024;20:780-793. © 2023 The Authors. Integrated Environmental Assessment and Management published by Wiley Periodicals LLC on behalf of Society of Environmental Toxicology & Chemistry (SETAC).

Establishing realistic exposure estimates of solitary bee larvae via pollen for use in risk assessment.

Bees foraging in agricultural habitats can be exposed to plant protection products. To limit the risk of adverse events, a robust risk assessment is needed, which requires reliable estimates for the expected exposure. The exposure pathways to developing solitary bees in particular are not well described and, in the currently proposed form, rely on limited information. To build a scaling model predicting the amount of protein developing solitary bees need based on adult body weight, we used published data on the volume of pollen solitary bees provide for their offspring. This model was tested against and ultimately updated with additional literature data on bee weight and protein content of emerged bees. We rescaled this model, based on the known pollen protein content of bee-visited flowers, to predict the expected amount of pollen a generalist solitary bee would likely provide based on its adult body weight, and tested these predictions in the field. We found overall agreement between the models' predictions and the measured values in the field, but additional data are needed to confirm these initial results. Our study suggests that scaling models in the bee risk assessment could complement existing risk assessment approaches and facilitate the further development of accurate risk characterization for solitary bees; ultimately the models will help to protect them during their foraging activity in agricultural settings. Integr Environ Assess Manag 2022;18:308-313. © 2021 The Authors. Integrated Environmental Assessment and Management published by Wiley Periodicals LLC on behalf of Society of Environmental Toxicology & Chemistry (SETAC).

Recalibration of the earthworm tier 1 risk assessment of plant protection products.

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 0-1 cm to 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 5 cm 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 5 cm is used. Integr Environ Assess Manag 2016;12:643-650. © 2015 SETAC.

Biomass or growth rate endpoint for algae and aquatic plants: relevance for the aquatic risk assessment of herbicides.

Ecotoxicological studies with algae and aquatic plants are essential parts of the aquatic risk assessment for crop protection products (CPP). Growth rate is used as a response variable and in addition the effects on biomass and/or yield (in the following biomass) can be measured. The parameter biomass generally provides a lower numerical value compared with the growth rate for systematic and mathematical reasons. Therefore, some regulators prefer to use the EbC50 value (i.e., the concentration at which 50% reduction of biomass is observed) rather than ErC50 (the concentration at which a 50% inhibition of growth rate is observed) as the endpoint for ecotoxicological risk assessment. However, the parameter growth rate is scientifically more appropriate and robust against deviations in test conditions, permitting better interpretation of, and comparison between, studies. The aim of the present work is to evaluate the growth rate and biomass parameters with regard to their protectiveness and suitability for environmental risk assessment of CPP. It has been shown for a number of herbicides that the use of the EC50 value (without distinction between growth rate and biomass endpoints) from laboratory studies in combination with an assessment factor of 10 is sufficiently protective for aquatic plants (except for the herbicide 2,4-D). In this paper we evaluated EbC50 and ErC50 values separately. Data on 19 different herbicides were compiled from the literature or GLP reports. The EbC50 and ErC50 values obtained in laboratory studies were compared with effect concentrations in ecosystem studies (mainly mesocosm). This comparison of laboratory and field data shows that the overall aquatic risk assessment using ErC50 values in combination with the currently applied assessment factor of 10 is sufficient to exclude significant risk to aquatic plants in the environment.