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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well as for approval of active substances in plant protection products (PPP) supporting a stepwise risk assessment. 34 unpublished exposure studies conducted between 1994 and 2009 were evaluated for the new model.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.

This guidance is designed to assist risk assessors and applicants when quantifying potential non‐dietary, systemic exposures as part of regulatory risk assessment for plant protection products (PPPs). It is based on the Scientific Opinion on ‘Preparation of a Guidance Document on Pesticide Exposure Assessment for Workers, Operators, Residents and Bystanders’ developed by the EFSA Panel on Plant Protection Products and their Residue (PPR) in 2010. Highlighting some inconsistencies between the approaches adopted by regulatory authorities, the PPR Panel proposed a number of changes to the practices in use (i.e. use of deterministic methods for individual PPPs; need to perform an acute risk assessment for PPPs that are acutely toxic; use of appropriate percentile for acute or longer term risk assessments). In the first version of the guidance, issued in 2014, several scenarios for outdoor uses were included, with an annexed calculator, as well as recommendations for further research. The guidance has been updated in 2021 with the inclusion of additional scenarios and revision of default values, on the basis of the evaluation of additional evidence. To support users in performing the assessment of exposure and risk, an online calculator, reflecting the guidance content, has been further developed.

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