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Culleres, Damia Barcelo
Opinion of the PPR Panel related to the appropriate variability factor(s) to be used for acute dietary exposure assessment of pesticide residues in fruit and vegetables / Damia Barcelo Culleres on behalf of European Food Safety Authority, contr. G. Suszter
Acknowledgement: The Scientific Panel wishes to thank Á. Ambrus, P. Craig, G. Suszter and E. Walters for the contributions to this draft opinion.
In a batch of food items previously treated with a pesticide, the residue of the pesticideremaining on/in single food items at the time of consumption varies between items,due to a variety of factors. So there is a distribution of residues, with some itemscontaining more pesticide than others. It is important to take account of this variationwhen assessing the risk to consumers from acute dietary exposure to pesticides inmedium and large-sized food items (e.g. apples or melons). Therefore, internationalassessment procedures are based on the 97.5th percentile of the distribution ofresidues; i.e. the level that is exceeded by 2.5% of residues in food items (i.e. 1 in 40).This residue level is not measured directly, but estimated by measuring theconcentration in a small batch of items and multiplying it by a "variability factor" toestimate the 97.5th percentile residue.Recently, it has been proposed that a default value of 3 should generally be used forthe variability factor, replacing a range of default values for different commodities. TheCommission has asked the PPR Panel to advise on the scientific basis for choosing asingle default value for the variability factor.The PPR Panel examined the range of variability factors from existing studies whereresidues were measured separately in individual food items. The PPR Panel excludedfrom this analysis studies for which the variability factor could not be estimatedreliably, i.e. studies with less than 50 items, or where the result was strongly affectedby pesticide residues below the level that could be quantified.On average, variability factors estimated from samples collected in the marketplacewere higher than those from samples obtained in experimental studies (supervisedtrials). The PPR Panel therefore recommends that consideration be given to usingdifferent variability factors when doing exposure assessments with data from these twotypes of study.The average variability factor for supervised trials was 2.8. However, the variabilityfactor is itself variable, and the Commission may wish to consider this when choosingan appropriate default value for use in dietary exposure assessments. To assist in this,the PPR Panel provides tables presenting a range of statistics. For example, it isestimated that the variability factors for supervised trials will exceed the proposeddefault value of 3 in 34% of cases, whereas the previous default value of 7 for mediumsizedfood items will be exceeded in 0.2% of cases. Similarly, the variability factors formarket surveys averaged 3.6, and will exceed 3 in about 65% of cases and 7 in about1% of cases.The EFSA Journal (2005) 177, 1-612The data analysed by the PPR Panel related mostly to medium-sized commodities(between 25 and 250 g, e.g. apples). The PPR Panel concluded there was insufficientevidence to support a real difference between variability factors for medium and largesizedcommodities, and therefore considered its results applicable to both types.However, the PPR Panel recommends that this should be re-examined when furtherdata on large-sized commodities become available.The results are affected by a number of uncertainties. The PPR Panel calculatedconfidence intervals to indicate the degree of uncertainty due to limitations in theamounts of data available for the analysis. Other uncertainties, e.g. in extrapolatingvariability factors between pesticides and between crops, were considered qualitatively.Finally, the PPR Panel noted that the assessment of acute risks from dietary exposureuses conservative assumptions for portion size and the mean residue concentration aswell as the variability factor. The combined effect of these conservative assumptions onthe overall level of consumer protection may warrant further consideration.
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acute dietary exposure
EFSA Journal 177 : 3 (2005), p. 1-61. -
Kötelesné Suszter Gabriella (1976-) (műszeres analitikus szakvegyész)
European Food Safety Authority
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