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1、WU028B-15WU0XX/RamaOctober24,200215:54LS0203BestpracticesinestablishingdetectionandquantificationlimitsforpesticideresiduesinfoodsJohannesCorleyRutgers,TheStateUniversityofNewJersey,NorthBrunswick,NJ,USA1IntroductionToday,increasedglobalizationhasresultedineasy
2、movementofagriculturalproductsfromonepartoftheworldtoanother.Thediversityinrulesandregulationsacrossthedifferentnationshaspromptedtheglobalharmonizationofdifferentregulatoryagenciestoestablishjointtolerancesormaximumallowableresiduelimits(MRLs),andestablishbes
3、t/uniformriskassessmentguidelines.Thishasledtothenecessitytoadoptuniformmethodstodefinethelimitationsofananalyticalmethod.Withoutanappropriatedefinition,analyteconcentrationsreportedbyamethodcanbemeaning-lessbecausecalculatedvaluesofdetectionlimitscanvaryoverano
4、rderofmagnitudedependingonthemethodusedtodeterminethesevalues.1,2Thedefinitionsofmethoddetectionandquantificationlimitsshouldbereliableandapplicabletoavarietyofextractionproceduresandanalyticalmethods.TheissueisofparticularimportancetotheUSEnvironmentalProtectio
5、nAgency(EPA)andalsopesticideregulatoryandhealthagenciesaroundtheworldinriskassessment.Thecriticalquestioncentraltoriskassessmentisassessingtheriskposedtoahumanbeingfromtheconsumptionoffoodstreatedwithpesticides,whentheamountoftheresiduepresentinthefoodproducti
6、sreported‘nondetect’(ND)or‘nodetectableresidues’.Iftheanalyteofinterestisnotdetectedbytheinstrument(oranalyticalprocedure),doesitmeanthatthereisnotasinglemoleculeofthatanalytepresentinthefoodproduct?Ordoesitmeanthattheanalyteispresentataconcentrationthatisjust
7、belowthecapabilityoftheinstrument?Orisitpresentataconcentrationsomewherebetweenthesetwoextremes?OnemajorproblemcausedbySection409(c)(3)oftheFederalFood,DrugandCosmeticAct,commonlyknownasthe‘DelaneyClause’,whichgovernedtheregis-trationofpesticideswasthestatemen
8、t,‘Noadditiveshallbedeemedsafeifitisfoundtoinducecancerwheningestedbymanoranimal,...’.3DrFredR.Shank,Director,CenterforFoodSafetyandAppliedNutrition,USFoodandDrugAdministration,inH
