A new predictive model for the estimation of agricultural operator exposure has been developed on the basis of new exposure data to improve the current agricultural operator exposure and risk assessment in the EU. The new operator exposure model represents current application techniques and practices in EU Member States (MS) and is applicable for national or zonal authorisation of plant protection products as well as for approval of active substances in plant protection products (PPP) supporting a stepwise risk assessment. 34 unpublished exposure studies conducted between 1994 and 2009 were evaluated for the new model. To ensure a very high quality of data the studies had to meet a set of quality criteria, e.g. GLP conformity or compliance with OECD guidance. Exposure data and supplementary information on the trials were used for a statistical analysis of exposure factors. The statistical analyses resulted in six validated models for typical outdoor scenarios of pesticide mixing/loading and application. As a major factor contributing to the exposure of operators, the amount of active substance used per day was identified. Other parameters such as formulation type, droplet size, presence of a cabin or density of the canopy were selected as factors for sub-scenarios. For two scenarios the corresponding datasets were too small to identify reliable exposure factors; instead the relevant percentiles of the exposure distribution were used. The whole project report on the development of the new model (including the underlying study data) and the corresponding exposure calculators will be published at the BfR website (http://www.bfr.bund.de) after confirmation of the model by EU MS.

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