CropLife Europe Crop Development Database: An open-source, pan-European, harmonized crop development database for use in regulatory pesticide exposure modeling and risk assessment.

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 2023;00:1-15. © 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).

Environmental exposure assessment of co-formulants in plant protection products under REACH.

It is a regulatory requirement to assess co-formulants in plant protection products (PPP) under the European Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) legislation. The standard environmental exposure assessment framework for chemicals under REACH is a multicompartmental mass-balanced model and, at the local scale, is designed for use with urban (wide dispersive) or industrial (point source) emissions. However, the environmental release of co-formulants used in PPP is to agricultural soil and indirectly to waterbodies adjacent to a field and, for sprayed products, to the air. The Local Environment Tool (LET) has been developed to assess these specific emission pathways for co-formulants in a local-scale REACH exposure assessment, based on standard approaches and models used for PPP. As such, it closes a gap between the standard REACH exposure model's scope and REACH requirements to assess co-formulants in PPP. When combined with the output of the standard REACH exposure model, the LET includes an estimate of the contribution from other nonagricultural background sources of the same substance. The LET is an improvement over the use of higher tier PPP models for screening purposes because it provides a simple standardized exposure scenario. A set of predefined and conservatively selected inputs allows a REACH registrant to conduct an assessment without requiring detailed knowledge of PPP risk assessment methods or typical conditions of use. The benefit to the co-formulant downstream user (formulators) is a standardized and consistent approach to co-formulant assessment, with meaningful and readily interpretable conditions of use. The LET can serve as an example to other sectors of how to address possible gaps in the environmental exposure assessment by combining a customized local-scale exposure model with the standard REACH models. A detailed conceptual explanation of the LET model is provided here together with a discussion on its use in a regulatory context. Integr Environ Assess Manag 2023;19:1544-1554. © 2023 BASF SE, Bayer AG et al. Integrated Environmental Assessment and Management published by Wiley Periodicals LLC on behalf of Society of Environmental Toxicology & Chemistry (SETAC).

REACH Specific Environmental Release Categories for Plant Protection Product Applications.

The European Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) regulation requires that quantitative environmental risk assessment is carried out for hazardous substances used as coformulants in plant protection products (PPPs), if registered above 10 t/y. The European Crop Protection Association (ECPA) has developed generic exposure scenarios and specific environmental release categories (SpERCs) to support these risk assessments. The SpERCs offer refinements to the default release factors defined in environmental release categories (ERCs) and are intended to be used with nested multimedia mass balance models as part of the assessment of regional predicted environmental concentrations. Based on the application method of PPPs, 2 scenarios were defined for which SpERCs were developed: 1) spraying of PPPs and 2) direct application of granular products or treated seeds to soil. The SpERC for spray applications includes release factors to air and soil that depend on the vapor pressure of the coformulant. Calculations are presented to support the subSpERCs describing the transition from nonvolatile to volatile behavior. The most recent version of the spray application SpERC defines a release factor for surface water and more conservative release factors to soil compared with previous versions. Use of the ECPA SpERCs allows the coformulant emissions from PPPs to be fully accounted for in the regional-scale environmental risk assessment for a given substance, along with all other sources of emissions. Qualitative and quantitative justification for the ECPA-derived SpERCs is presented and serves as the background documentation to the online European Chemicals Agency (ECHA) SpERC factsheets. The approach developed here whereby regional-scale SpERCs are used in combination with a customized local-scale exposure model is potentially applicable for other sectors that are required to conduct exposure assessments outside the scope of the standard environmental REACH models. Integr Environ Assess Manag 2020;16:472-480. © 2020 Syngenta Crop Protection AG. Integrated Environmental Assessment and Management published by Wiley Periodicals, Inc. on behalf of Society of Environmental Toxicology & Chemistry (SETAC).

Meeting report: risk assessment of tamiflu use under pandemic conditions.

On 3 October 2007, 40 participants with diverse expertise attended the workshop Tamiflu and the Environment: Implications of Use under Pandemic Conditions to assess the potential human health impact and environmental hazards associated with use of Tamiflu during an influenza pandemic. Based on the identification and risk-ranking of knowledge gaps, the consensus was that oseltamivir ethylester-phosphate (OE-P) and oseltamivir carboxylate (OC) were unlikely to pose an ecotoxicologic hazard to freshwater organisms. OC in river water might hasten the generation of OC-resistance in wildfowl, but this possibility seems less likely than the potential disruption that could be posed by OC and other pharmaceuticals to the operation of sewage treatment plants. The work-group members agreed on the following research priorities: a) available data on the ecotoxicology of OE-P and OC should be published; b) risk should be assessed for OC-contaminated river water generating OC-resistant viruses in wildfowl; c) sewage treatment plant functioning due to microbial inhibition by neuraminidase inhibitors and other antimicrobials used during a pandemic should be investigated; and d) realistic worst-case exposure scenarios should be developed. Additional modeling would be useful to identify localized areas within river catchments that might be prone to high pharmaceutical concentrations in sewage treatment plant effluent. Ongoing seasonal use of Tamiflu in Japan offers opportunities for researchers to assess how much OC enters and persists in the aquatic environment.

A monitoring programme for 1,3-dichloropropene and metabolites in groundwater in five EU countries.

BACKGROUND: 1,3 Dichloropropene (1,3-D) is a preplanting soil fumigant for the control of cyst and free-living nematodes and is currently undergoing a resubmission under Annex 1 listing of Directive 91/414/EEC. The characteristics of 1,3-D are such that the risk of it or its soil metabolites leaching through the soil profile cannot be excluded. As such, groundwater monitoring programmes were established in five EU countries representing a wide range of agricultural, climatic and hydrogeological situations, covering a range of groundwater vulnerability scenarios. All monitoring was conducted in areas where there has been historical use of 1,3-D. RESULTS: Over 5000 groundwater samples were analysed for the presence of 1,3-D and its metabolites over a 2 year period. Almost all analyses (for parent and metabolites) yielded concentrations of <0.1 microg L(-1). There were just two detections of >0.1 microg L(-1) (0.12 microg L(-1) and 0.4 microg L(-1)) for the 3-chloroacrylic acid metabolite in shallow groundwater samples of the alluvial gravels of the River Tiétar in the Caceres region of Spain. CONCLUSION: Groundwater monitoring programmes have been conducted in the EU in five countries. These have demonstrated that there is negligible contamination of groundwater with 1,3-D or its metabolites across a range of agroclimatic regions where 1,3-D is known to have been used for a number of years. Local scientific knowledge of geological features, hydrology, agricultural practice and specific local issues was essential to the conduct of the study.