Unit to unit variation of pesticide residues - options for acute dietary risk assessment

Within the context of the current UK policy for those commodities where the potential variability of residues in individual commodity units is taken into account, a variability factor nu, which reflects the ratio of a high level residue in the individual commodity unit to the corresponding composite residue level, is used. Data gathered from supervised industry trials in which individual items were analysed following treatment, although limited, show that variability is typically lower than that reflected by the default factors currently used and that the range of variability is reproducible over the limited range of different a.i./crop/method of application combinations investigated. In order to improve the accuracy of the acute dietary exposure estimate, the European Crop Protection Association (ECPA) proposes the following alternative to the current Tier I approach. The residue level input from a 'hot' unit within the dietary risk assessment should be determined using the highest composite sample residue from supervised field trials and a generic variability factor (nu) determined experimentally from supervised trials. The variability factor itself should be calculated as the 95th percentile level of the residue level found in an individual unit (or single serving portion for large crops) divided by sample mean for data produced from supervised trials. This would improve the accuracy of the Tier I approach and allow attention to be focused on particular a.i./crop/method of application combinations where the NESTI> acute RfD (based on a Tier I assessment) and generation of individual unit residue data for the particular outlet or other mitigation may be appropriate.