RESUMO
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).
RESUMO
REACh introduces environmental release categories (ERCs) used to describe chemical emissions to the environment. These ERCs contain a number of default values that are combined with product usage data to estimate environmental exposure concentrations for use in risk assessment. The methodology presented in the present work constitutes a novel approach that allows for the coupling of population density and country-specific usage statistics for a range of home and personal care products. Spatially explicit usage estimates are presented for European Union (EU) hypothetical regions (200 × 200-km grid), as described in EU risk assessment frameworks. Recent sales and population density data are combined to assess the relevance of current default assumptions; that 10% of a product will be used in an EU hypothetical region that is inhabited by 20 million people. It is demonstrated that these assumptions are conservative and their relevance geographically limited. The highest usage estimates for hypothetical regions are located in southern England and a transboundary area in Europe consisting of Belgium, the Netherlands, and Germany. The maximum identified usage of 9 home and personal care product types, in an EU hypothetical region, ranges from 4.3% to 11.4%. The 99.5th percentile values, representative of an EU hypothetical region with a population of 20 million, range from 3.6% to 9.0%, which suggests that the current default parameterization of the ERCs may be overly protective for ingredients used in a number of home and personal care product types. Accordingly, it may be justified to use such an analysis to refine the default values in order to provide more realistic exposure estimates for use in REACh assessments.
