volV) (0123456789().,-volV) can move into the groundwater specified in the exposure assessment option as well as the magnitude of residues in groundwater. The objective may also include determining degradation rates in soil as a function of depth, persistence and movement of residues in groundwater, efficacy of mitigation measures, or confirmation of more detailed studies on a wider range of sites. Sampling schedules should consider the expected time required for an active substance to move through the soil into groundwater, as well as expected persistence in both soil and groundwater. Movement and persistence can be affected by both site characteristics and properties of the active substance and its metabolites. The need to tailor study designs to objectives, exposure assessment options, compound properties and site characteristics complicates the development of standardised study designs. Therefore, this report includes a number of example designs.Other key points that must be addressed by study designs are the vulnerability of the chosen sites compared to the vulnerability of all use areas supported by the study, the product use before and during the study, and the connectivity of the sampled groundwater to treated fields. Demonstrating connectivity (a quality criterion in the EU assessment of monitoring sites to exclude false negative measurements) is more challenging for catchment or aquifer monitoring compared to shallow wells installed as part of in-field or edge-of-field studies. This report includes an extensive discussion on assessing vulnerability of monitoring sites. This includes information on different approaches to vulnerability assessment and mapping as well as for setting monitoring sites into context. Lists of available methods and data sources available at the European level are also included. In addition to information on study design and estimating vulnerability, this report includes information on a number of other topics: avoiding contamination during sampling and/or analysis, avoiding influencing residue movement as a result of purging during sampling, and proper study documentation (Good Laboratory Practices and/or quality criteria). Procedures that are discussed include site selection (new or existing wells), installation of monitoring wells, sample collection, and analysis of samples. The report also provides information on causes of outliers (abnormally high concentrations not the result of normal leaching through soil), the use of public monitoring data, information on further hydrological characterisation (such as use of tracers, groundwater age dating, and geophysical methods), and information that should be included in reports providing results of groundwater studies. AbstractGroundwater monitoring is recommended as a higher-tier option in the regulatory groundwater assessment of crop protection products in the European Union. However, to date little guidance has been provided on the study designs. The SETAC EMAG-Pest GW group (a mixture of regulatory, academic, and industry scien...

A comprehensive multiyear monitoring program was conducted to assess the exposure, effects, and long-term risk of the fungicide bixafen to earthworms in cereal fields. The realistic exposure of bixafen in soil was assessed at 10 representative field sites in Germany after a period of up to 8 years of use with five different products containing bixafen, followed by annual measurements from 2017 to 2019. The measured exposure concentrations were compared with modeled predicted environmental concentrations in soil (PECsoil) that are derived in the context of the European risk assessment of plant protection products. It was shown that the model assumptions, in particular the kinetic parameters describing the background accumulation, provided a conservative description of the observed residue data. This demonstrates that the exposure modeling tools are adequate for use in soil risk assessment. Laboratory and field ecotoxicological studies were performed to provide a comprehensive risk assessment on the long-term use of bixafen-based fungicides in cereals. While a laboratory reproduction study with the earthworm Eisenia fetida indicated a potential risk at the Tier 1 risk assessment for the end-use product Skyway XPro ® , a 2.5-year field study showed no unacceptable long-term effects on natural earthworm populations. The exposure in this study exceeded the maximum recommended field rate of Skyway XPro ® by a factor of 3 and the maximum measured bixafen concentrations from exposure monitoring study by a factor of 5.2. Hence, an acceptable long-term risk of bixafen-based cereal fungicides is concluded for earthworms.