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Measuring adverse effects on honey bees and their colonies requires a suitable methodology. For example, due to the large number of bees in a hive and the foraging activity, measuring the mortality of individuals is a difficult task that has not yet been adequately addressed. Knowing the natural daily mortality rate of a bee colony would be of great benefit in assessing whether and to what extent external influences and stress factors affect mortality. More precise mortality data could in turn help refining specific protection goals for regulatory purpose. The European Food Safety Authority recently published a document that estimated such mortality rates based on a systematic literature review, but none of these rates were assessed from continuous monitoring of colonies. Currently, bee mortality is routinely evaluated with various types of dead bee traps that prevent deceased bees from being removed from the colony. Both the literature review and the dead bee traps are relevant to regulatory risk assessment, but in our opinion are not describing the total mortality. Bee counters capable of precisely determining daily loss rates meet the above points and combine them with generating automated and continuous monitoring data. Lately, the field has gained a lot of importance in research and technological advances offer new possibilities in regulatory risk assessment. We will highlight these possibilities and discuss their future application in practice. [ABSTRACT FROM AUTHOR]

There is a regulatory need for crop development dates to assess current default values used within chemical exposure assessments as well as to justify refinements within risk assessments. However, a readily available pan‐European crop phenology database covering key FOrum for the Co‐ordination of pesticide fate models and their USe (FOCUS) crops and scenarios to meet this need is not currently available. Therefore, we describe the development of a harmonized, pan‐European, CropLife Europe Crop Development Database (C2D2), that is fully aligned with this regulatory requirement utilizing efficacy trials data generated for regulatory submissions when registering plant protection products under Regulation (EU)1107/2009. Evaluation of C2D2 against an independent data set showed good agreement for equivalent time periods, crop growth stages, and geographical regions. We illustrate how this database can be used to evaluate existing default crop development dates mandated by regulatory agencies for use within exposure assessments. Despite the large data set compiled and the geographical coverage of C2D2, not all FOCUSsw/gw scenarios have sufficient data to facilitate comparison, with less significant scenarios, like FOCUSgw Porto, being underrepresented. For those scenarios with sufficient data, clear differences between C2D2 and crop development dates assumed in the FOCUS modeling framework (using the AppDate tool) are often indicated over many growth stages, suggesting that amendment of the existing representation of crop development within the risk assessment process may be required. C2D2 is freely available under a Creative Commons license to facilitate innovation in exposure science to allow for more accurate and realistic risk assessment leading to enhanced crop and environmental protection. Integr Environ Assess Manag 2024;20:1060–1074. © 2023 CropLife Europe (Corteva Agriscience) and The Authors. Integrated Environmental Assessment and Management published by Wiley Periodicals LLC on behalf of Society of Environmental Toxicology & Chemistry (SETAC). Key Points: A freely available, harmonized, pan‐European crop development database (CropLife Europe Crop Development Database [C2D2]) has been developed by CropLife Europe for use in regulatory chemical exposure assessments by collating and harmonizing efficacy trials data generated for regulatory submissions when registering plant protection products.C2D2 comprises a wide range of crops (combinable, root, vegetable, top fruit, soft fruit), spans two decades (2000–2020), and covers 30 countries facilitating comparison with current regulatory scenarios, which suggests that amendment of the existing representation of crop development may be required.Evaluation of C2D2 against an independent data set from Germany for equivalent time periods and crop growth stages showed good agreement, promoting its use in exposure science innovation to allow for more accurate and realistic risk assessment leading to enhanced crop and environmental protection.C2D2 holds significant opportunities for future development of crop models to improve estimates and timing of chemical exposure, not only for use in chemical fate and transport models but also for nontarget organism, for example, pollinators, effect, and risk assessment. [ABSTRACT FROM AUTHOR]

Before plant protection product (PPP) marketing authorization, a risk assessment for nontarget soil organisms (e.g., earthworms) is required as part of Regulation (EC) No. 1107/2009. Following a stepwise approach, higher tier earthworm field studies are needed if they cannot demonstrate low long‐term risk based on laboratory studies. The European guidance for terrestrial ecotoxicology refers to ISO guideline 11268‐3 as a standard to conduct earthworm field studies. Assessment of such studies may be challenging, as no European harmonized guidance is available to properly analyze the accuracy, representativeness, and appropriateness of experimental designs, as well as the statistical analysis robustness of results and their scientific reliability. Following the ISO guideline 11268‐3, a field study was performed in 2016–2017 (Versailles, France). An assessment of the first year of this field study was performed in agreement with the quality criteria provided in 2006 in the guidance document published by de Jong and collaborators and recommendations by Kula and collaborators that allows describing the protocol and results of earthworm field studies. Not only did we underline the importance of a detailed analysis of raw data on the effects of pesticides on earthworms in field situations, but we also provided recommendations to harmonize protocols for assessing higher tier field studies devoted to earthworms to advance a better assessment of PPP fate and ecotoxicity. In particular, we provided practical field observations related to the study design, pesticide applications, and earthworm sampling. Concurrently, in addition to the conventional earthworm community study, we propose carrying out an assessment of soil function (i.e., organic matter decomposition, soil structuration, etc.) and calculating diversity indices to obtain information about earthworm community dynamics after the application of PPPs. Finally, through field observations, any relevant observation of external and/or internal recovery should be reported. Integr Environ Assess Manag 2023;19:254–271. © 2022 The Authors. Integrated Environmental Assessment and Management published by Wiley Periodicals LLC on behalf of Society of Environmental Toxicology & Chemistry (SETAC). KEY POINTS: The de Jong guidance and the recommendations provided by Kula and collaborators are used to assess an earthworm field study performed following the ISO 11268‐3 guideline of 2014.Recommendations are provided to harmonize protocol on assessing higher tier field studies devoted to earthworms for a better assessment of plant protection products fate and ecotoxicity. [ABSTRACT FROM AUTHOR]

Honeybees have world-wide importance as crop pollinators. To ensure their persistence in agricultural systems, statistically robust field trials of plant protection products are vital., We consider the implications of regulations from the European Food Safety Authority that require the detection of a 7% effect size change in bee colony sizes under field conditions., Based on a power analysis, we argue that the necessary levels of replication (68 replicates) may pose practical constraints to field testing., Policy implications. Regulatory studies benefit from data sources collated over a range of spatial scales, from laboratory to landscapes. Basing effect size thresholds solely on expert judgement, as has been done, may be inappropriate. Rather, definition through experimental or simulation studies that assess the biological consequences of changes in colony size for bee populations is required. This has implications for regulatory bodies outside the European Union. [ABSTRACT FROM AUTHOR]