Guidance on the assessment of exposure of operators, workers, residents and bystanders in risk assessment for plant protection products

Regulation (EC) No 1107/2009 ensures that the residues of plant protection products (PPPs), consequent to application consistent with good plant protection practice and having regard to realistic conditions of use, shall not have any harmful effects on human health. In 2010, the EFSA Panel on Plant Protection Products and their Residues (PPR) prepared a Scientific Opinion on “Preparation of a Guidance Document on Pesticide Exposure Assessment for Workers, Operators, Residents and Bystanders”, which highlighted some inconsistencies between the approaches adopted by regulatory authorities. Therefore, the PPR Panel proposed a number of changes to those practices in use (e.g. routine risk assessment for individual PPPs should continue to use deterministic methods, and a tiered approach to exposure assessment remains appropriate; there is a need to introduce an acute risk assessment for operators, workers and bystanders where PPPs are acutely toxic; for acute risk assessments, exposure estimates should normally be based on 95^th percentiles of relevant datasets, whereas, for longer term risk assessments, the starting point should be a 75^th percentile). To prepare a Guidance Document, an ad hoc working group was established to revise all available data and procedures to perform the operator, worker, resident and bystander risk assessment. In addition to the data reported in the PPR opinion, further data were made available to the working group which were analysed and considered. The opinion also identifies those scenarios for which exposure estimates are least satisfactory, and makes recommendations for further research that would reduce current uncertainties. An exposure calculation spreadsheet, reflecting the Guidance content, is annexed to this Guidance Document, to support stakeholders in performing the assessment of exposure and risk.