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Q  /x$XHXXXXHXXXH  iv    _zXXHThisisprovidedfordemonstrativepurposesonly.OPPGuidelinesactuallyrecommendeightcropfield  trialsforbellpeppersandaminimumof16samples;thereforeitisunlikelythat10compositebellpeppersamplesfromfivefieldtrialswouldbeadequateforuseinaprobabilisticriskassessment.Thefivefieldtrialscitedhereareforillustrativepurposesonly.#XHXz# d'"&% I&mage <=8C HKKKK(Z3]$ !XAXXXXAXXXA  $$$$'dxd d'dxd( $ Figure  1  Level 1Level 2Level 3Level 4Level 5)*"+,C<< CLevel 1Level 2Level 3Level 4Level 5(Z3]$ !XAXXXXAXXXA  ($$   1  --' dxdP Pd(;3$2#  0  .3  0  TABLE G>$"Small Circle"0  2 WPC  ! 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Std Error .-0Courier New- !0.035079  .-0Courier New- !0.007438 .-0Courier New- !0.032045( .-0Arial- !t Ratio .-0Courier New- ! 52.62  .-0Courier New- !-15.22 .-0Courier New- !-20.84( .-0Arial- !Prob>|t| .-0Courier New- !<.0001   .-0Courier New- !<.0001  .-0Courier New- !<.0001(   9>'(F$0  0` (#(#0 ` (#` (#0 (# (#0h(#(#2#(   )3  0h(#h(#e WPCWW!W2ƚ U[   e--^0---^0- s .-0Arial- !Summary of Fit----  $X .-0Courier New- !RSquare( .-0Courier New- ! RSquare Adj6 .-0Courier New-!Root Mean Square ErrorD .-0Courier New-!Mean of ResponseR .-0Courier New-!Observations (or Sum Wgts)` .-0Courier New- !0.961042( .-0Courier New- !0.9581566 .-0Courier New- ! 0.08776D .-0Courier New- ! 1.10422R .-0Courier New- ! 30`  q' XTABLE Cj WPCm m 11!1" ƚmH  <  I--^0---^0- <  .-0Arial-!Parameter EstimatesD----  Rz@  .-0Arial-!TermV .-0Courier New- ! Interceptd .-0Courier New-!phir .-0Arial- !EstimateVv .-0Courier New- ! 1.1634715d_ .-0Courier New- ! -0.109228r_ .-0Arial- ! 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RSquare Adj6 .-0Courier New-!Root Mean Square ErrorD .-0Courier New-!Mean of ResponseR .-0Courier New-!Observations (or Sum Wgts)` .-0Courier New- !0.961453( .-0Courier New- !0.9570066 .-0Courier New- !0.088958D .-0Courier New- ! 1.10422R .-0Courier New- ! 30`  q'(@$0  0` (#(#0 ` (#` (# ` X----'dxd'dxd d'dxdXXCCrelXX6.XXXXC0XXXXlC1XX XC1XX6XXvC2XXX4C2XXXX  C3XXT X C1XX X C2XX( XX F d'dxd *EGMSY_ekqAutoList44A.1.A.A.A.A.A.A.&0 d d'dxd&P d ddd(d2dt .-0Courier New- !C TotalLt .-0Arial-!DF" .-0Courier New- ! 20 .-0Courier New- ! 27> .-0Courier New- ! 29L .-0Arial- !Sum of Squares" .-0Courier New- ! 5.12980470 .-0Courier New- ! 0.2079496> .-0Courier New- ! 5.3377543L .-0Arial- ! Mean Square"4 .-0Courier New- ! 2.564900< .-0Courier New- ! 0.00770>< .-0Arial- !F Ratio" .-0Courier New- !333.02470{ .-0Arial- !Prob>F> .-0Courier New- ! <.0001L{  ] o'TABLE D aFSUP*~=~{0.0213~+~0.00301}OVER{2}~DIV~{0.2031}OVER{184}~=~0.838(EGMSY_ekqAutoList341.1.1.1.1.1.1.1. !XX%FCXXgM#XEXX\f0XXf.XXf0213XXfXXf0XX\f.XXf00301XXXO2XX3  X XX f0XX f.XX f2031XXn O18XXN OXX O4XX XX 0XX5.XXm838(UEGMSY_ekqAutoList241.1.1.1.1.1.1.1.(EGMSY_ekqAutoList35IIIIIIIIIIIIIIII EGMSY_ekqAutoList361.1.1.1.1.1.1.1.(ŤEGMSY_ekqAutoList371.1.1.1.1.1.1.1.TABLE C(jEGMSY_ekqAutoList20A.A.A.A.A.A.A.A.   /x$XHXXXXHXXXH  3    _zXXHԀAsadditionaldatafromthesebridging/residuedeclinetrialsareprovidedtoandanalyzedbyOPPand  OPPisabletofurtherinvestigatetheputativesimilaritiesanddifferencesthatexistamongandbetweencropgroups,moreguidanceonextrapolationtoadditionalcropgroupsorclassificationsmaybepossible.#XHXz#(O;$0  2#  a  .3  0` (#(#(eEGMSY_ekqAutoList191.1.1.1.1.1.1.1.(zEGMSY_ekqAutoList21A.A.A.A.A.A.A.A. E~CSUBrel~=~betaSUB0~+~betaSUB1XSUB1~+~varepsilon(EGMSY_ekqAutoList22A.A.A.A.A.A.A.A. EGMSY_ekqAutoList23A.1.A.A.A.A.A.A.(eEGMSY_ekqAutoList251.1.1.1.1.1.1.1.(uEGMSY_ekqAutoList261.1.1.1.1.1.1.1.(EGMSY_ekqAutoList17A.A.A.A.A.A.A.A. EGMSY_ekqAutoList18A.1.A.A.A.A.A.A. EGMSY_ekqAutoList271.1.1.1.1.1.1.1.(EGMSY_ekqAutoList291.1.1.1.1.1.1.1.(EGMSY_ekqAutoList30A.A.A.A.A.A.A.A. eEGMSY_ekqAutoList311.1.1.1.1.1.1.1. ʹEGMSY_ekqAutoList32A.1.A.A.A.A.A.A. ڹEGMSY_ekqAutoList33A.1.A.A.A.A.A.A.   /x$XHXXXXHXXXH  i    _ԀzXXHPriortoperforminganylinearregressiontodevelopaquantitativerelationshipbetweenrelativeresidue  andrelativeapplicationrate,itwouldbenecessarytoverifythatthevariancesdonotdiffersignificantlyamongtreatmentratesandtrials(i.e.,totestforhomogeneityofvariance).Althoughnotspecifically j illustratedhere,BartlettsandLevinestestfordetermininghomogeneityofvarianceareamongseveralteststhatcanbeperformed.ThesearemorefullydescribedinEPAspublication GuidanceforDataQualityAssessments:PracticalMethodsforDataAnalysis;(U.S.EPA1998).Thisdeterminationisaprerequisitetoperformingavalidlinearregression(i.e.,linearregressionassumesthatvariancesare   equal).#XHXz#XXmCCrelXXXX&C0XXXXC1XXFXC1XX\XX,F WPCWW!W2ƚ U[   e--^0---^0- s .-0Arial- !Summary of Fit----  $X .-0Courier New- !RSquare( .-0Courier New- ! RSquare Adj6 .-0Courier New-!Root Mean Square ErrorD .-0Courier New-!Mean of ResponseR .-0Courier New-!Observations (or Sum Wgts)` .-0Courier New- !0.753655( .-0Courier New- !0.7382586 .-0Courier New- !0.119243D .-0Courier New- !0.752222R .-0Courier New- ! 18`  q'TABLE E   /x$XHXXXXHXXXH  ii    _zXXHԀIftherateofresidueincreaseissignificantlyimpactedbylocation,thenalternativescouldincludeuse  ofthesmallerslopeforalllocationsoruseofeachregionalspecificrelationshipinaproportionappropriateforthepercentofthecropthatisproducedthere.#XHXz#Appendix 2-    /x$XHXXXXHXXXH  vi    _zXXHAlternatively(andequivalently),theseresiduevaluescouldbeinsertedintofourseparatefiles(one  eachrepresentingvaluesofzeroresidues(fornontreated),threedays,sixdays,and10dayswithassociatedprobabilitiesof75%,5%,7.5%,and12.5%,respectively).#XHXz#,  AZ Arial Italic   /x$XHXXXXHXXXH  iii    _zXXHAgain,iftherateofresidueincreaseissignificantlyimpactedbylocation,thenalternativescouldinclude  useofthesmallerslopeforalllocationsoruseofeachregionalspecificrelationshipinaproportionappropriateforthepercentofcropthatisproducedthere#XHXz#.    /x$XHXXXXHXXXH  iii    _zhXHԀNotethatthettestisappropriateinthisinstancebecausethereareonlytwotrials.Inthecaseofcrops  inwhichthreetrialsarerequired,itisappropriatetotestthatnoregressionslopesaredifferentandasecondinteractionterm(4)wouldbenecessarytoproperlycodethevariables.Inthiscase,themore D generalpartialFtest(andnotthettest)wouldbetheappropriatestatisticalproceduretoapply.#XHXz#WPC! ƚ?F  r sj--^0---^0- kr .-0Arial- ! Lack of Fitz----  Bv .-0Arial- !Source .-0Courier New- ! Lack of Fit .-0Courier New- ! Pure Error .-0Courier New- ! Total Error .-0Arial-!DFt .-0Courier New- ! 7^ .-0Courier New- ! 20^ .-0Courier New- ! 27^ .-0Arial- !Sum of Squares .-0Courier New- ! 0.01831394 .-0Courier New- ! 0.18963568 .-0Courier New- ! 0.20794963 .-0Arial- ! Mean Square .-0Courier New- !0.002616 .-0Courier New- !0.009482 .-0Arial- !F RatioA .-0Courier New- ! 0.2759* .-0Arial- !Prob>F@ .-0Courier New- ! 0.9562* .-0Arial- !Max RSq- .-0Courier New- !0.9645.  is'   /x$XHXXXXHXXXH  iv    _ԀzXXHAgain,iftherateofresiduedeclineissignificantlyimpactedbylocation,thenalternativescouldinclude  useoftheslowestdegradationrateforalllocationsoruseofeachregionspecificdegradationrateinaproportionappropriateforthepercentofcropthatisproducedthere.#XHXz# j http://www.ams.usda.gov/science/pdp/Labop03.pdf   /x$XHXXXXHXXXH  1    _ԀzXXHAlthoughtheguidanceandexamplesprovidedinthisdocumentarespecifictotherefinementsofacute  dietaryriskassessments,theprinciplesdiscussedcanbereadilyappliedtochronicassessmentsaswell.#XHXz#Ԁhttp://www.epa.gov/r10earth/offices/oea/epaqag9.pdf,  AZ"Arial Regular!z J  /x$XHXXXXHXXXH  ii    _XHXXXHzXXHԀIftherewasanyindicationofsignificantdifferencesinslopebetweenthefieldtrials,thenanalysis  wouldproceedonacasebycasebasis;thiscouldincludeuseoftheslowestdegradationrateforalllocationsoruseofeachregionalrateinproportiontopercentofcropgrowninthatregion.#zz##XHXz# q *]"XAXXXXAXXXA  _ ? XXA     @6  ?U.S.EnvironmentalProtectionAgency  OfficeofPesticideProgramsJune15,2000#?  @6# ,, 8L AArial Bold !XAXXXXAXXXA  _5458AXXdd8  & %XXAFaxonDemand  ЀTeleponehone:(202)4010527̀ItemNo.:6063#XAX %&# X  XXA   `     h   #XAXQ#   `     h     @@JXXAGuidanceforRefiningAnticipated j   ResidueEstimatesForUseinAcuteDietaryProbabilisticRiskAssessment#XAXJM#  f  , ` ` (#(#{(OC3/lz p pE` f&` f&{    #,d')` `  #_@0w@  DISCLAIMER     {  ThepolicydocumentdiscussedinthisnoticeisintendedtoprovideguidancetoEPApersonnelanddecision-makers,andtothepublic.Asaguidancedocumentandnotarule,thepolicyinthisguidanceisnotbindingoneitherEPAoranyoutsideparties.AlthoughthisguidanceprovidesastartingpointforEPAriskassessments,EPAwilldepartfromitspolicywherethefactsorcircumstanceswarrant.Insuchcases,EPAwillexplainwhyadifferentcoursewastaken.Similarly,outsidepartiesremainfreetoassertthatapolicyisnotappropriateforaspecificpesticideorthatthecircumstancessurroundingaspecificriskassessmentdemonstratethatapolicyshouldbeabandoned.  2   ? XXATableofContents#XAX ?#      zVm  zVm5 0     ListofAcronyms #""J(#.  (#(##1zVm5 Q ݌ 0 Ќ  zVm  zVm 0     ExecutiveSummary #""J(#.  (#(##2zVm  ݌   Ќ  zVm  zVm 0     I.0(#(#Introduction #""J(#. (#(##3zVm ݌   Ќ  !  ! 0  0` (#(#    A.0` ` (#` (#OPPsTieredApproachtoExposureEvaluation #""J(#.@` (#` (##6! ݌ p  Ќ     0  0` (#(#0 ` (#` (# `   1.0 (# (#Tier1andTier2Assessments#""J(#.^^6 (# (##6 ݌ \   Ќ     0  0` (#(#0 ` (#` (# `   2.0 (# (#Tier3andTier4Assessments#""J(#.^^6 (# (##7 ݌ B  Ќ  !  !0  0` (#(#    B.0` ` (#` (#PotentialAnticipatedResidueRefinements #""J(#.PP=` (#` (##8!݌ (x  Ќ    0  0` (#(#0 ` (#` (# `   1.0 (# (#Cooking/ProcessingStudies#""J(#.3 (# (##8݌ d  Ќ    0  0` (#(#0 ` (#` (# `   2.0 (# (#BridgingStudies#""J(#.jj) (# (##9݌ J  Ќ    0  0` (#(#0 ` (#` (# `   3.0 (# (#ResidueDeclineStudies#H"H"I(#.BB0 (# (##10݌ 0  Ќ    0  0` (#(#0 ` (#` (# `   4.0 (# (#ResidueDegradationStudies#H"H"I(#.4 (# (##10݌  Ќ  zVm  zVm0     III.0(#(#Cooking/ProcessingStudies #H"H"I(#.)(#(##11zVm݌  Ќ  zVm  zVm0     IV.0(#(#MarketBasketData #H"H"I(#.BB!(#(##12zVm݌ d Ќ  zVm  zVm0     V.0(#(#ResidueDegradationStudies #H"H"I(#.*(#(##12zVm݌ 6 Ќ  zVm  zVm0     VI.0(#(#BridgingandResidueDeclineStudies #H"H"I(#.,,3(#(##13zVm݌ X Ќ  !  !y0  0` (#(#    A.0` ` (#` (#Purpose,RecommendedLocation,andNumberofFieldTrials #H"H"I(#.X X M` (#` (##13!y݌ D Ќ  !  !0  0` (#(#    B.0` ` (#` (#NumberofApplicationRatesorPHIstobeTested #H"H"I(#.E` (#` (##15!݌ 0 Ќ    0  0` (#(#0 ` (#` (# `   1. BridgingStudies#H"H"I(#.jj) (# (##15݌  Ќ    0  0` (#(#0 ` (#` (# `   2.0 (# (#ResidueDeclineStudies#H"H"I(#.BB0 (# (##16݌  Ќ  !  !0  0` (#(#    C.0` ` (#` (#RecommendedSamplingProtocol #H"H"I(#.1` (#` (##16!݌  Ќ    0  0` (#(#0 ` (#` (# `   1.0 (# (#NumberofCompositeSamplestoCollectat݌ (# (# Ќ    0  0` (#(#0 ` (#` (# `   0 (# (#EachApplicationRateorPHI#H"H"I(#.5 (# (##16݌ j  Ќ    0  0` (#(#0 ` (#` (# `   2.0 (# (#Singleservingvs.CompositeSampling#H"H"I(#.TT> (# (##18݌ P! Ќ  !  !0  0` (#(#    D.0` ` (#` (#GenerationofAdjustedDataforIncorporation!݌8" ` (#` (# Ќ  !  ! 0  0` (#(#    0` ` (#` (#intotheProbabilisticAnalysis #H"H"I(#.3` (#` (##20! ݌ $#t! Ќ  !  !!0  0` (#(#    E.0` ` (#` (#IncorporationofAdjustedDataintoaProbabilisticAnalysis #H"H"I(#.ppP` (#` (##20!!!݌ $`" Ќ  !  !"0  0` (#(#    F.0` ` (#` (#AdditionalInformation #H"H"I(#.*` (#` (##21!""݌ $L # Ќ    #0  0` (#(#0 ` (#` (# `   1.0 (# (#Incorporationof LessthanLimitofQuantification##݌%8!$ (# (# Ќ    $0  0` (#(#0 ` (#` (# `   0 (# (#ValuesintoaRegressionRelationship#H"H"I(#.> (# (##21$$݌ &"% Ќ    %0  0` (#(#0 ` (#` (# `   2.0 (# (#ExtrapolationofResultsBetweenSimilarCrops#H"H"I(#...G (# (##23%%݌ '#& Ќ    &0  0` (#(#0 ` (#` (# `   & '݌ (#' (# (# Ќ    &0  0` (#(#0 ` (#` (# `   ?&0  0` (#(#0 ` (#` (# `   3.0 (# (#UseofMultipleLinearRegressionTechniquesinthe&'݌ (# (# Ќ    w(0  0` (#(#0 ` (#` (# `   0 (# (#SimultaneousAdjustmentofRateandResidueDeclineData#H"H"I(#. Q (# (##23w((݌  Ќ    )0  0` (#(#0 ` (#` (# `   4.0 (# (#FieldTrialRequirementsforPesticidesWithVariousChemical  and/orPhysicalForms#H"H"I(#.. (# (##24))݌  Ќ  zVm  zVm*0     VII.0(#(#References #H"H"I(#.B B (#(##25zVm*+݌ `  Ќ  zVm  zVm+0     Appendix10` (#(#ExampleAnalysisofBridgingDataandGenerationofzVmG,c,݌@ ` (#` (# Ќ  zVm  zVmK-0     zVmG,c,݌@ ` (#` (# Ќ  zVm  zVm_-0     Appropriately @  WeightedInputResidueFileforProbabilisticAnalysis #?(#.zzJ` (#` (##Appendix11zVm++݌ 0  Ќ  zVm  zVm.0     Appendix20` (#(#ExampleAnalysisofResidueDeclineDataandGenerationof `  AppropriatelyWeightedInputResidueFileforProbabilisticAnalysis  #?(#.` ` ` (#` (##Appendix21zVm..݌ @  Ќ  zVm__  zVmm00     4 O  5  60O0  7'1zVmm00݌ (#(# Ќ  XXH   ListofAcronyms 2#XHX1#   2  BDL0  0` (#(#BelowDetectionLimitH` (#` (# BQL0  0` (#(#XHXXXHBelowQuantification#XHXXXH3#XHXXXHԀLimit#XHXXXHs3#8` (#` (# CFR   ` CodeofFederalRegulations   p   ( CSFII   ` USDA'sContinuingSurveyofFoodIntakebyIndividuals   D0  0` (#(#Dusts ` (#` (# DEEM) ` DietaryExposureEvaluationModel   EC0  0` (#(#XHXXXHEmulsifiableconcentrates#XHXXXHW5#  ` (#` (# EPA   ` U.S.EnvironmentalProtectionAgency   FAO0  0` (#(#FoodandAgricultureOrganizationx ` (#` (# FIFRA ` TheFederalFungicide,Insecticide,andRodenticideAct h  FR0  0` (#(#FederalRegisterX ` (#` (# FQPA ` TheFoodQualityProtectionActof1996 H  G0  0` (#(#XHXXXHGranulars#XHXXXH7#8` (#` (# HAFT0  0` (#(#HighestAverageFieldTrial(x` (#` (# HED   ` TheHealthEffectsDivisionoftheOfficeofPesticidePrograms h LOD   ` LimitofDetection X LOQ   ` LimitofQuantification H MAFF0  0` (#(#UK'sMinistryofAgriculture,Fisheries,andFood8` (#` (# Mcap0  0` (#(#XHXXXHMicroencapsulated#XHXXXH:#(` (#` (# OPP   ` U.S.EPA'sOfficeofPesticidePrograms  OPPTS0 ` U.S.EPA'sOfficeofPrevention,Pesticides,andToxicSubstances` (#` (# PDP   ` U.S.DepartmentofAgriculture'sPesticideDataProgram  PHI   ` PreharvestInterval  SAP   ` TheFIFRAScientificAdvisoryPanel  SOP   ` StandardOperatingProcedure x UK0  0` (#(#TheUnitedKingdomh` (#` (# USDA ` U.S.DepartmentofAgriculture X  WHO0  0` (#(#WorldHealthOrganizationH!` (#` (# WP0  0` (#(#XHXXXHWettablepowders#XHXXXH=#8"` (#` (# %CT0  0` (#(#PercentofCropTreated (#x ` (#` (#   XXH    !XXHExecutiveSummary > @h #XHX ! ч># @  @  @p  @  @   @x  @ #XHX|>#  f>  Thisdocumentprovidesguidancetoregistrants,othertestsponsorsandinterestedparties,anddatareviewersontheextentandqualityofpesticideresidueandancillarydataneededtosupporttheuseofmorerefined anticipatedresiduesinacutedietaryprobabilisticexposureassessments  '  1      .Thepurposeofthisdocumentistooutline  ( thetypesofdatatheOfficeofPesticidePrograms(OPP)canusetorefineresidueestimatesforpesticidesandexplainwhenandhowtheU.S.EnvironmentalProtectionAgency(EPAortheAgency)mayusethesedata.Suchdatacaninclude(asisfurtherdiscussedinthedocument)informationfromcookingstudies,processingstudies,andmarketbasketsurveysconductedonindividualproduceitems.Inaddition,suchdatacanincludeinformationfrom bridgingstudiesusedtosupporttheuseoftypicalapplicationratesinprobabilisticriskassessmentsorresiduedeclinedatausedtosupporttheuseoftypicalpreharvestintervals(PHI)inprobabilisticriskassessments.Thisguidancealsoprovidesinformationonhowriskmitigationactivities(e.g., H  increasingPHIs,loweringmaximumlabelrates)canbeconsideredinOPPriskassessmentsandusedtoadjusttolerancelevels.  Itshouldbenotedthattheguidanceinthisdocumentisnotintendedtolimitorrestrictthetypeofdatathatmaybesubmittedinsupportofriskmitigationmeasures,andthatOPPwillconsiderotherdataorinformationaslongastheywouldprovideascientificallysoundbasisfordeterminingresiduesattypicalapplicationratesforriskmitigationpurposes.     I.0  Introduction F(#(#   InOctober1998,OPPmadeavailableforcommentits"GuidanceforSubmissionofProbabilisticHumanHealthExposureAssessmentstotheOfficeofPesticidePrograms;"(U.S.EPA1998a).Thestatedpurposeoftheguidancedocumentwastodescribeperformancestandardsforprobabilistichumanhealthexposureassessmentsdonefor,andby,OPP.Thedocumentwasnotintendedtoprovidestepbystepinstructionsonconductingprobabilisticassessments.Instead,theintentofthedocumentwastoprovideaconceptualframeworkthatwoulddescribewhichapproachesaremostappropriateforconsiderationinprobabilisticassessments.  ThedocumentstatedthatavarietyofinformationcouldbeusedtorefineOPPsestimatesofexposureandrisk,whichcouldincludeinformationanddataoncookingandprocessingstudies,singleservingmarketbasketsurveys,andresiduedeclinedata.ThedocumentnotedthatifprobabilisticexposureassessmentssubmittedtoOPPsHealthEffectsDivision(HED)incorporateddatabasedontherangeof typicalapplicationscenariosthatmaybemorerestrictive(lowerrates,fewerapplications,longerPHIs)thanthemaximumlabelconditions,thenthe_submitter_Ԁshouldpresentcertaininformationtoinsurethereliabilityofsuchdata.OPPstatedthatresiduedatashouldbeavailabletosupporttheinclusionoftypicalusepatterns,andthatassumptionsofrelationshipsbetweenapplicationratesandresultingresiduelevelsshouldbesupportedbydatacorrelatingmeasuredresiduevaluestoapplicationrates.  Additionaldetailsconcerningthisprobabilisticincorporationoftypicalapplicationscenarioswereprovidedinthefollowingpaper(whichwasmadeavailableforpubliccommentthroughtheFederalRegister):XHXXXH DataforRefiningAnticipatedResidue ` EstimatesusedinDietaryRiskAssessmentsforOrganophosphatePesticide;#XHXXXHzN#(U.S. P EPA1999a).Thisdocument,andtwosubsequentXHXXXHmoredetaileddocuments#XHXXXHO#Ԁentitled @  GuidancefortheConductofBridgingStudiesforUseinAcuteDietaryProbabilisticRiskAssessment;"(U.S.EPA1999b)and"GuidancefortheConductofResidueDeclineStudiesforUseinAcuteDietaryProbabilisticRiskAssessment;(U.S.EPA1999c)describedthetypesofdatathatcanbeusedtorefineresidueestimates,XHXXXH "  outlinedthebasiccharacteristicsofusefuldata,discussedhowresiduedataandusagedataarelinked,andexplainedhowOPPwouldusethesetypesofdatainitsdietaryexposureassessments#XHXXXHSQ#. % #   `'"%   TheAgencyreceivedcommentsonthethreeaforementioneddocumentsfromvariousorganizations.AllcommentswereextensivelyevaluatedandconsideredbytheAgency.Eachofthecommentersofferedrecommendationsforimprovingthesciencepolicy.Thisdocumentcombinesthethreepreviousdocumentssubmittedforpubliccommentintoonereviseddocumentthatembodiesmanyofthesentimentsandrecommendationsofthecommenters.Thepubliccomments,aswellasadetailedsummaryoftheAgencysresponsetothecommentsarebeingmadeavailableintheFederalRegister. @     `     h      p   Manycommentersincludingcommoditygroups,foodprocessors,andpesticideregistrants-indicatedintheircommentsthatinformationisavailableorcanbegeneratedthatcanmoreaccuratelycharacterizeactualpesticideusepracticesandactualresiduesthanthelabelinformationandanticipatedresiduefactorsthathavebeentraditionallyusedbyOPP.ThesegroupswouldliketheAgencytoconsiderandincorporatethesedatainitsdietaryriskassessmentsandinevaluatingpossibleriskmitigationforspecificpesticideuses.Thisinformationincludes,forexample,therangeofresiduesresultingfromvariousapplicationratesandvariousPHIs,thepercentageofpesticideusedatvariousapplicationrates,andthepercentageoftreatedcropsharvestedatvariousintervals.Suchdataareoftengeneratedroutinelyduringefficacyandresiduetestingprogramsassociatedwithproductdevelopment.Otherusefulinformationthatstakeholdersmaywishtoprovidewouldquantifythereductionsinresiduesfromstorage,cookingandprocessingpractices.  ThepurposeofthisdocumentistooutlinethetypesofdataOPPcanusetorefineresidueestimatesforpesticidesandexplainwhenandhowthesedatamaybeused.Specifically,thisdocumentisintendedtoprovideadditionalguidancetoregistrants,othertestsponsors,interestedparties,anddatareviewersontheextentandqualityofpesticideresidueandancillarydataneededtosupporttheuseofmorerefined anticipatedresiduesinacutedietaryprobabilisticexposureassessments(theprinciplesdiscussedinthecurrentdocument,however,canbereadilyappliedtochronicexposureassessmentsaswell).Suchdatacaninclude(asisfurtherdiscussedinthedocument)datafromcookingstudies,processingstudies,andmarketbasketsurveysconductedonindividualproduceitems.Inaddition,suchdatacanincludeinformationfrom bridgingstudiesusedtosupporttheuseoftypicalapplicationratesinprobabilisticriskassessmentsorresiduedeclinedatausedtosupporttheuseoftypicalPHIsinprobabilisticriskassessments.  p&!$   Thisguidancewillalsoservetoprovideinformationonhowriskmitigationactivities(e.g.,increasingPHIs,loweringmaximumlabelrates)canbeconsideredin  OPPriskassessmentsandusedtoadjusttolerancelevels.Itshouldbenotedthattheguidanceinthisdocumentisnotintendedtolimitorrestrictthetypeofdatathatmaybesubmittedinsupportofriskmitigationmeasures,andthatOPPwillconsiderotherdataorinformationaslongastheywouldprovideascientificallysoundbasisfordeterminingresiduesattypicalapplicationratesforriskmitigationpurposes.  XHXXXH  ThispolicydocumentisintendedtoprovideguidancetoEPApersonneland_decisionmakers_Ԁandtothepublic.Asaguidancedocumentandnotarule,thepolicyinthisguidanceisnotbindingoneitherEPAoroutsideparties.AlthoughthisguidanceprovidesastartingpointforEPAriskassessments,EPAwilldepartfromthispolicywherethefactsorcircumstanceswarrant.Insuchcases,EPAwillexplainwhyadifferentcoursewastaken.Similarly,outsidepartiesremainfreetoassertthatapolicyisnotappropriateforaspecificpesticideorthatthecircumstancessurroundingaspecificriskassessmentdemonstratethatapolicyshouldbeabandoned#XHXXXHn`#.      Thisdocumentisdividedintosevensections.Thefirstsectionisthisintroduction.SectionIIprovidesanoverviewofOPPstieredapproachtoriskassessmentandthevalueofrefinedanticipatedresiduedata.SectionsIII,IV,V,andVIprovidefurther,moredetailedinformationofcooking/processingstudies,marketbasketsurveys,residuedegradationstudies,andbridgingandresiduedeclinestudies,respectively.Thelastsection(SectionVII)providesalistofreferences.Finally,twoappendicesareincluded.Appendix1providesillustrativesamplestatisticalandothercalculationsforbridgingstudieswhileAppendix2providescomparableinformationforresiduedeclinestudies(whichwouldalsobeapplicableforresiduedegradationstudies).  @  II.0  OPPsTieredApproachandValueofRefinedAnticipatedResidueData (#(# 0   A.0` (#(#OPPsTieredApproachtoExposureEvaluation Ag` (#` (# 0   ` OPPtypicallyhasusedatieredapproachtoacutedietaryriskassessment.Generallyspeaking,thelevelofresourcesanddataneededtorefineexposureestimatesincreasewitheachtier.Lowertier(Tiers1and2)exposureassessmentsuseresiduelevelsderivedfromguidelinecropfieldtrialdata(tolerancelevels)andcan(forcertaincrops)usereadilyavailableusageinformationsuchasthepercentofthecropthathasbeentreated(%CT)withaparticularpesticide.Theseestimatestendtooverestimateactualpesticideresiduesinfoodatthepointofconsumption.Generally,ifdietaryrisksfrompesticideresiduesinfoodarenotofconcernusinglowertierexposureestimates,nofurtherrefinementsaremade.WithaggregateandcumulativeassessmentsnowrequiredbytheFoodQualityProtectionActof1996(FQPA),itislikelythathighertier(Tiers3and4)exposureestimateswillbeneeded.Thesehighertierassessmentsmayinvolveprobabilistictechniques(i.e.,MonteCarloanalysesfor  acuteassessment),oftenincorporatingprocessingfactors(e.g.,washing,  cookingdata),degradationdata(forstoredcommodities),marketbasketsurveyinformation,andotherinformationthatallowsOPPtomorefullyconsiderdistributionsofresiduevalues.Thesetieredapproachesaremorefullydescribedbelowandin"ClassificationofFoodFormsWithRespecttoLevelofBlending.HEDStandardOperatingProcedure99.6;"(U.S.EPA1999d). (#(# 0  0` (#(#  1.0 ` (#` (#Tier1andTier2Assessments n 0 (# (# 0  0` (#(# ResidueinformationsubmittedtotheAgencytosupportregistrationsanddeterminetolerancesrepresentsmaximumlabeledapplicationratesandminimumlabeledPHIs.These"worst-case"conditionsareusedtoensurethattolerancesaresetatlevelsthatencompassthehighestresiduesthatcouldbefound.Intheabsenceofreliablemonitoringdata,currentprocedurescallfortheuseofthesecontrolledfieldtrialresiduevalues(derivedfrommaximumapplicationratesandminimumPHIs)inexposureandriskassessments.Oftentimes,thisistheonlyinformationthatisavailabletotheAgencyforuseintheseassessments. ` (#` (#   p&!$ 0  0` (#(# OPPrecognizesthattheseresiduesdonotnecessarilyreflect(inthesetiers)realworldusepracticesnordeclinesinresidueduetotimebetweenharvestandconsumptionnortypicalcommercialandconsumerpracticessuchaswashing,peeling,cooking,etc.TheAgencyrecognizesthatusingresiduedatafromonlythemaximumapplicationrateandtheminimumPHIinriskassessmentsmayoverestimatetheactualresidueonfoodsforanumberofreasons.Chiefamongtheseare:notallapplicationsoccuratthemaximumlabelrate;andsomecropsaretreatedlongbeforeharvest-ineffectcreatingalongerPHI. ` (#` (# 0  0` (#(#  2.0 ` (#` (#Tier3andTier4Assessments t P  (# (# 0  0` (#(# Incaseswheretheregistrantbelievesthattherangeofreal-worlduseratesissignificantlylowerthanmaximumapplicationratesortherangeofreal-worldPHIsissignificantlygreaterthantheminimumlabelPHI,itmaybeadvantageoustoincorporatethisinformationintoprobabilistic(i.e.,Tier3andTier4)acuteexposureandriskassessments.  Thisinformationcanbeincorporated,however,onlyifreliableusagedataareavailablefordeterminingwhatpercentageofthecropistreatedatwhichrate(and/orwhatpercentageisharvestedatwhichPHIs).Together,residuedatacollectedfromaseriesofreduced-useormulti-PHIfieldtrialsandinformationonreal-worldapplicationratesorPHIswouldenableOPPtoincorporatetheresiduevaluesresultingfromtheentirerangeofapplicationratesand/orPHIsintheexposureassessment.OPPemphasizesthatbothmulti-rateand/ormulti-PHIresiduedataspecificallycollectedforthispurposeandappropriateuserelateddataarerecommendedtoimplementthisrefinement;neitherone,byitself,issufficient.Thereaderisreferredtoacompanionpaperentitled,"TheRoleofUse-RelatedInformationinPesticideRiskAssessmentandRiskManagement;"(U.S.EPA1999e)forfurtherdiscussionofthesourcesofusedataandhowEPAemploysthesedatainitsassessments. ` (#` (#   #! 0   B.0` (#(#PotentialAnticipatedResidueRefinements ]z` (#` (# 0   ` Thetieredapproachdescribedabovepermitsanumberofanticipatedresiduerefinementstobemadethatmayprovevaluablewhenusedtoobtainbetterestimatesofexposureforuseinriskassessment.Suchstudiescaninclude,forexample,cooking/processingstudies,bridging(orreduceduse)studies,residuedeclinestudies,andresiduedegradationstudies.Eachofthesestudiesisdescribedtoalimiteddegreebelow.Additional,detailedspecificsregardingthedesignandconductofthesestudiesareprovidedsubsequentlyinsectionsIII,IV,V,andVIofthisdocument. (#(# 0  0` (#(#  1.0 ` (#` (#Cooking/ProcessingStudies w} P  (# (# 0  0` (#(# CookingandotherhomeprocessinginformationiscurrentlyincorporatedintoOPPriskassessmentsonlytotheextentthatthisinformationismadeavailabletoOPP.IfanOPPriskassessmentusesresiduedatageneratedfromfieldtrialsasonecomponentoftheinputfile,thentheeffectsofcookingandhomepreparation/processingarenottypicallyfactoredintotheassessmentunlessadditionalstudiesorinformationthatquantifiesthedegreeofreductionareprovidedbythedatasubmitted. ` (#` (# 0  0` (#(# DatageneratedaspartoftheU.S.DepartmentofAgricultures(USDA)PesticideDataProgram(PDP),ontheotherhand,doesimplicitlyincorporatetheeffectsofhomepreparationinthattheproducesampledbyPDPispreparedinthelaboratoryasifforconsumption.Thisgenerallyincludes,forexamplewashingand,whenappropriate,peeling,trimming,coring,orpitting,dependinguponthecommoditysampled.Thus,theeffectsofnormalhomepreparation(exceptforcooking)isimplicitlyincorporatedintotheOPPriskassessmentwhenPDPdataareused. ` (#` (#     0  0` (#(# TheeffectsofcommercialprocessingareincludedintheriskassessmentbyuseofdefaultprocessingfactorsincludedintheDietaryExposureEvaluationModel(XHXXXHDEEM)#XHXXXHu#)exposureandriskassessment  softwareusedbyOPP.Ifinformationisavailablethatindicatesadifferentprocessingfactorismoreappropriate,thenthisrevisedprocessingfactorisincorporated.OPPGuidelinesspecificallyrecommendthatprocessingstudiesbeperformedoncertaincommodities(X.f XXXHe.g#XHX XX.f#,cornintocornoil, @  soybeanintosoybeanmeal,etc.)inwhichcasetheseexperimentallydeterminedfactorsareincorporatedintoOPPriskassessments.However,ifaregistrantorotherdatasubmittedchoosestoprovideadditionalstudiesforothercommoditiesforwhichOPPguidelinesdonotrecommendprocessingstudies,thisinformationwillbeusedaswellandwillberoutinelyincorporatedintotheassessment. ` (#` (# 0  0` (#(#  2.0 ` (#` (#BridgingStudies 7  (# (# 0  0` (#(# Datafrombridging(orreduceduse)studiescanbeusedtoestablisharelationshipamongresiduesfromfieldtrialsconductedatthemaximumapplicationscenario(X.f XXXHe.g#XHX XX.fn#,maximumapplicationrate,highest  applicationfrequency,andshortestPHI)andresiduesexpectedattherangeofmoretypicalrates.Thistypeofstudyisintendedto"bridge"pesticideresidueconcentrationsbetweenmaximumapplicationratesusedtodeterminetolerancesandtherangeofmoretypicalratesatwhichthepesticideisactuallyapplied.Generally,bridgingstudiesconsistofoneormorefieldtrialsusingseveraldifferentapplicationrates.Theapplicationsshouldoccuratthesamelocationandatthesametime.Theyareusedtoestablishtherelationshipbetweenapplicationrateandresultingresiduelevel.Thisinformation,togetherwithuse/usageinformationonwhatfractionofthecropistreatedateachrate,permitstheAgencytorefineitsestimatesofexposurebyincorporatingresiduesresultingfromthefullrangeofapplicationratesinitsprobabilisticassessments.Thisinformation,togetherwithinformationonwhatfractionofthecropistreatedatwhatrate,couldbeusedtoproduceadistributionofresiduevaluesforuseinaprobabilisticassessment.Bridgingstudiesandrelatedusageinformationwillinfluencethedietaryriskassessmentmostwhentherearelargedifferencesbetweenthemaximumandtypicalapplicationrates,andwhenalargepercentageoftheapplicationsoccursatlessthanthemaximumrate. ` (#` (#   0*%( 0  0` (#(#  3.0 ` (#` (#ResidueDeclineStudies s  (# (# 0  0` (#(# Similartodatafrom bridgingstudies,residuedeclinedatarefertodatathatcanbeusedtoestablisharelationshipbetweenresiduelevelsatthetimeofapplication(oratthelabelPHI)andresiduelevelsattherangeoftypicalharvesttimes.ThesestudiesrecognizethatnotallcropsareharvestedatthelabeledminimumPHIandareusedtoestablishtherelationshipbetweenthetimeofharvest(relativetothelastpesticideapplication)andtheleveloramountofresiduesfoundonthecommodity.Becausepesticidesdegradeanddissipateatdifferentratesovertime,itcannotbeassumedthatthisrelationshipislinear,e.g.,thatdoublingthe `  PHIwouldresultinhalftheresidue.Inaresiduedeclinestudy,samplesfromasinglefieldtrialarecollectedatmultiplePHIsandanalyzedtodetermineratesofresiduedisappearance/dissipation.Aminimumofthreeintervalsisrecommended,althoughatleastfivearepreferable.Thisinformation,togetherwithuserelatedinformationonwhatfractionofthecropisharvestedateachinterval,wouldpermittheAgencytorefineitsestimatesofexposurebyincorporatingthefullrangeofPHIs.ThiskindofinformationismostusefulwhentherearelargedifferencesbetweentheminimumlabeledandtypicalPHIsandwhenthesepesticidalcompoundsarerelativelyshortlived. ` (#` (# 0  0` (#(#  4.0 ` (#` (#ResidueDegradationStudies  P (# (# 0  0` (#(# Residuedegradationisaconceptthatissimilartoresiduedecline,exceptresiduedeclineisconsideredtooccurbetweenpesticide  p applicationandharvestwhileresiduedegradationisconsideredtobea ` postharvestprocess(i.e.,occurringbetweenharvestandconsumer P purchase).Thisinformationmaybeparticularlyusefulwhenasubstantialperiodoftimeelapsessubsequenttoharvestbutpriortoconsumptionif,forexample,extendedtransportationorstoragetimesareinvolved. ` (#` (#   "    III.0  Cooking/ProcessingStudies (#(#   Cookingandprocessingdatapermitbetterestimatesofpesticideexposurebyincorporatinginformationonactualconsumerandindustryfoodpreparationpractices,suchaswashing,peeling,andvariouscookingmethods.  TheAgencyrecognizesthathomeprocessing(includingwashing,peeling,cooking,etc.)cansignificantlyreduceexposuretopesticides.Forexample,potatoeswouldlikelybecookedpriortoconsumptionandorangesandbananaswouldbepeeled.Ifinformationisavailableonhowthesepracticesaffectresiduelevelsintheconsumeditem,theAgencyiswillingtoconsiderdatathatquantifythesereductions.Inahomeprocessing/cookingstudy,residuemeasurementsintherawagriculturalcommodityaremadepriortocooking/washing/peelingandagainaftercooking/washing/peeling.ThisreductionfactorcanthenbeincorporatedintotheriskassessmentifthereisadditionalinformationconcerningtheprevalenceofthesepracticesoriftherelevantfoodformisreportedinUSDAsContinuingSurveyofFoodIntakebyIndividuals(CSFII)(e.g.,XHXXXHpeeled#XHXXXHy#Ԁorange;XHXXXHraw#XHXXXHʜ#Ԁpotatovs.XHXXXHbaked#XHXXXH!#Ԁpotatovs.XHXXXHfried#XHXXXHz#  potato).  InformationontheeffectsofcommercialfoodprocessingonpesticideresiduescanalsobeconsideredbyOPPinitsriskassessmentprocess.Incommercialprocessingstudies,samplesarecollectedfromatleasttwopointsintheprocessingprocedures(e.g.,beforeprocessing/cooking,afterwashing,afterpeeling,attheendof @ processing,etc.)andaprocessingfactor(typicallyalargereduction)iscalculated.Theprocessingpracticesusedinthestudyshouldreflecttypicalcommercialpractices̀(_e,g_,istherawagriculturalcommoditytypicallywashed,peeled,cookedorotherwise ` treatedbeforecanning,freezing,dryingorothertypesofprocessing)andOPPsriskassessmentshouldreflecthowprevalentthesepracticesareandwhetherthesepracticesrepresenttheindustryasawholeortheirvariationbyregion.Ideally,forcomparisonpurposes,residuedatawouldbeavailabletocompareresiduesoncommoditiesatvariousstagesofprocessing--astheycomeintotheplant,afterwashing,andafterpeelingorcooking.  #!   IV.0  MarketBasketData k(#(#   Marketbasketdataareintendedtocharacterizethedifferencebetweenthelevelofresiduethatisfoundoncommoditiesinthefieldandtheresiduesthatremainatthetimeofpurchasebytheconsumer.Marketbasketsurveysusestatisticallydefinedsamplingproceduresdesignedtoproduceresiduedatathatcanbedirectlyusedinaprobabilisticassessment.Generally,samplesarecollectedatthepointofsaletotheconsumer(e.g.,supermarketsorconveniencestores).Samplesmaybepreparedfor  p  consumption(e.g.,peeledorwashed)andgenerallyfollowUSDAsPesticideData `  Program(PDP)samplepreparationprotocol(see4egO  5  http://www.ams.usda.gov/science/pdp/Labop03.pdf6OeAg  7srϥԀforthepreparationprotocolfora @  varietyoffruits,vegetables,andgrains).Thesetypesofdataareparticularlyusefulincharacterizingtheactualresiduesoncommoditiesthataretypicallyconsumedfreshasasingleserving,forexample,apples,orangesandtomatoes.  V.0  ResidueDegradationStudies (#(#   Similartoresiduedeclinestudies(seebelow),residuedegradationstudiesseektoimproveOPPsassessmentofexposures.OPPrecognizes,forexample,thatsomecropssuchasapplesandpotatoescanbetypicallystoredforrelativelylongperiodsoftimeafterharvestandbeforepurchasebytheconsumer.Otheritems(e.g.,tomatoes @ andbananas)maybetypicallypickedgreenforeaseoftransport;ofnecessity,manydayscan,therefore,passbetweenharvestandconsumption.Residuedegradationstudiesaredesignedtocharacterizethedecreasingamountsofpesticideresiduesovertimeoncommoditiesduringstorageortransportation(incontrasttoresiduedecline P studiesthatseektocharacterizethedecreasingconcentrationofresiduesbetweenpesticideapplicationandharvest);residuedegradationstudiesincorporateaspectsofbothresiduedeclineandprocessingstudies.Inaresiduedegradationstudy,samplesarecollectedbeforestorageortransportationbeginsandatdifferentpointsinthe"process"thatcorrespondtotimesthatconsumersmaypurchasethefood.  $"   VI.0  BridgingandResidueDeclineStudies (#(#   BridgingandresiduedeclinedatacanbeusefulinthattheypermitOPPtoincorporatearangeofresiduesresultingfromvariousapplicationratesorPHIsthatareusedinactualpractice.Thissectiondiscussessomeofthespecificissuesthatareassociatedwiththesestudies.OPPnotes,importantly,thatthisinformationisvaluableandcanbeusedonlywhenPDPorothermonitoringdataarenotavailable.IfPDPorothermonitoringdataareavailable,thismonitoringinformationwillgenerallysupercededataresultingfrombridgingorresiduedeclinestudies.0   A.0` (#(#Purpose,RecommendedLocation,andNumberofFieldTrials d@ ` (#` (# 0   ` Forbridging(orreduceduse)studies,sidebysidefieldtrialsshouldbe   designedtocompareresiduesresultingfrommaximumlabelconditions(i.e.,  thoseconditionsusedtoderiveatolerance)totherangeofmoretypicalapplicationrates.Similarly,residuedeclinestudiesshouldbedesignedto  compareresiduesresultingfromharvestattheminimumlabelPHI(i.e.,those  conditionsusedtoderiveatolerance)totherangeofmoretypicalPHI.Generally,suchcomparativedatashouldbeobtainedfrombetweenoneandthreefieldtrialsdependingonthenumberofrecommendedfieldtrialsestablishedintheResidueChemistryguidelines!XHXXXHԀseeTablesinOPPTSTest P Guidelines,ResidueChemistry,860.1500forthisandotherbasicinformationontheconductoffieldtrials(U.S.EPA1996).#XHXXXH#0(#(#   ` 0   ` Specifically,theminimumnumberoffieldtrialsrecommendedfortheresiduedeclinestudiesisasfollows: (#(# *?$@ddd Xdd Xdd X(#(#,( dd",@dd",dd"+  8#  d8zXXHNumberofResidueField 4 TrialsRecommendedbyOPPTSGuidelinesforTolerancesettingpurposes jU<B "d djRecommendedMinimumNumberandLocationofSitesforSidebySideFieldTrialstoEstablishBridgingorResidueDeclineData >4.x  "d > 6! r   d6RecommendedNumber U@+  "d dURecommendedRegion(s) @6+ & "d @morethan12trials ' N" '3sites ' N" '1inregionwithlargestproductionofthecommodity1inregionwithsecondlargestproduction1inregioninwhichlargestHAFTwasfound1 '\ " '6to12trials ' " '2sites ' " '1inregionwithlargestproductionofthecommodity1inregioninwhichlargestHAFTwasfound2#XHXz۵#zXXH 'N " '3to5trials '" '1site '" '#XHXz#zXXH1inregionwithlargestproductionofthe  commodity#XHXzY# +!v" +zhXH1The HAFTreferstotheHighestAverageFieldTrial.IfnoHAFThaspreviouslybeendetermined $ (as,forexample,withanewchemicalornewuseofanoldchemical),thistrialshouldinsteadbeperformedintheregionwiththelargestproduction. h 2IfthiscoincideswiththeregionwiththelargestproductionornoHAFThasbeendetermined(e.g.,for 2  anewchemicalornewuseofanoldchemical),thistrialshouldinsteadbeperformedintheregionwiththesecondlargestproduction.%""   %#XHXz#__0   ` DataestablishingrelationshipsbetweenresiduesandapplicationratesorPHIsshouldbederivedfromfieldtrialsconductedatthesamesiteandatthesametimebecauseofthepotentialimpactofenvironmentalconditionsandvariabilityinstudyconductonresults.Therefore,onlydatafromcontrolledfieldtrialsspecificallydesignedandcollectedtomonitortheeffectsofapplicationrateorPHIonresiduescangenerallybeused.Asanexample,itwouldgenerallyNOTbeappropriatetoattempttoderivearelationshipbetweenapplicationrateandresultingresiduesifdatafromoneapplicationratewereobtainedfromafieldtrialconductedinCaliforniain1992andresiduesatanotherapplicationratewereobtainedfromfieldtrialsconductedatthesamelocationorelsewherethreeyearslater.Similarly,itwouldgenerallyNOTbeappropriatetoattempttoderivearelationshipbetweenPHIandresultingresiduesifdatafromdifferentPHIswereobtainedfromfieldtrialconductedatdifferentlocationsoratdifferenttimes.Inallcases,dataprovidedshouldincludeweatherandprecipitationrecordstoenhancetheevaluationofastudyanditsresults. (#(#   )%2 0   B.0` (#(#NumberofApplicationRatesorPHIstobeTested ` (#` (# 0  0` (#(#  1. BridgingStudies  ` (#` (# 0  0` (#(# Sincethepurposeofthebridging(reduceduse)fieldtrialsistocompare(or bridge)theresiduesresultingfromthemaximumapplicationratetothoserepresentingtypicalrate(s),oneapplicationrateineachfieldtrialshouldbeatthemaximumlabelrate(i.e.,thatrateusedtoestablish 0  thetolerance);residuesatotherrateswillbecomparedtoresiduesatthismaximumratetoestablishtherelationshipbetweenapplicationrateandresultingexpectedresidueconcentrations.Atleasttwoother(preferablylower)applicationratesshouldbeselected(foratotalofatleastthreerates)sothatarelationshipbetweenapplicationrateandresiduelevelcanbecalculatedandused.Theregistrantorothersponsorshouldideallyincludeinitsfieldtrialsthemaximumlabelrate,theminimumlabelrate,andatleastoneadditionalintermediaterate(preferablya typicalrateoraratemidwaybetweenthemaximumandminimumrates). ` (#` (# 0  0` (#(# Insomecaseswhenstudiesaretobeconductedtodeterminetherelationshipbetweenapplicationrateandresiduelevel,itmaybepreferable(particularlyifLOQlevelsandcanbeusedintheregressionanalysis.Applicationrates,however,shouldnotbeexcessivelyexaggerated(e.g.,nomorethan5x)sincedoingsomay #! fundamentallyalterdecayparametersandprocessesandthisshouldnotbeusedtocompensateforagenerallyinadequateanalyticalmethod. ` (#` (#   p&!$ p+    0  0` (#(# Thislimitationisnotexpectedtopresentaseriousimpedimenttowidespreaduseofthemethod:ifnonquantitativeresiduesarefoundata5xexaggeratedratethentheriskassessmentwouldgenerallybeconductedbyassumingresiduesarepresentat1/10theLOQanditisunlikelythatthetestedcommoditieswouldbeasignificantriskdriverorthatadata_submitter_Ԁwouldhavefounditnecessarytoconductbridgingorresiduedeclinefieldtrialsinthefirstplace.Again,theresiduevaluesobtainedfromanyshorterthanlabelPHIorexaggeratedratelevelwillgenerallynotbeuseddirectlyintheriskassessment,butwillonlybeused  p  toestablishtheappropriatedecayparametersorproportionateapplicationratefactors. ` (#` (# 0  0` (#(# ThepurposeofthepolicyguidancedocumentrecommendationthatmeasurementsbelowtheLOQnotbeusedinquantitativeregressionanalysisindeterminingtheeffectapplicationrate(orPHI)hasonresiduelevelsistoencouragetheuseofexaggeratedratessuchthatresiduemeasurementscanbeadequatelyquantified.OPPneverthelesswillconsiderandevaluatethedatageneratedfromfieldtrialsinwhichBDL(BelowDetectionLimit)orBQL(BelowXHXXXHQuantification#XHXXXHh#ԀLimit)  measurementsareobtained.Asalways,theOPPreviewercanusehisorherjudgementandconcludethatincorporationofBQLorBDLmeasurementsintoquantitativeestimatesofthisrelationshipisappropriate,dependingonthespecificsofthecase.Inthesesituations,OPPwilllikelyinvestigatetherobustnessoftheregressionanalysisbyperformingasensitivityanalysisoftheregressionrelationship.Thatis,thesensitivityofthefinalestimatedrelationshiptoassumptionsregardingthevalueassociatedwiththeBQLorBDLcanbeassessedtodetermineifincorporationofBQLorBDLmeasurementmightsignificantlyaffecttheoutcomeofthestudyorassessment.  '  2      0` (#` (# 0  0` (#(# OPP,however,believesthattheconcernaboutapotentialpreponderanceofBQLorBDLvalueswhenfieldtrialsareconductedat1xandlowerratesismisplaced.BDLandBQLvaluesgenerallydonotsignificantlyaffectOPPdietaryriskestimatesanditisdoubtfulthatbridgingorresiduedeclinestudieswouldbeconductedoncropsforwhichBQLorBDLresiduesareexpected. ` (#` (#  `'"% 0  0` (#(#  2.0 ` (#` (#ExtrapolationofResultsBetweenSimilarCrops   (# (# 0  0` (#(# Extrapolationofdatabetweensimilarcropsmaybeallowedonacasebycasebasis,consideringsimilarculturalpracticesandapplicationpatterns.Ataminimum,OPPwouldexpectthatthecropgroupingsystemusedinestablishingtolerances(40CFR180.41)wouldbeextendedto `  bridging/residuedeclinestudies.Thatis,studiesconductedonthreerepresentativecrops(aslistedintheCodeofFederalRegulations)within @  acropgroupcouldbereadilyextendedtotheentirecropgroup.  '  3      0 ` (#` (# 0  0` (#(#  3.0 ` (#` (#UseofMultipleLinearRegressionTechniquesinthe `  SimultaneousAdjustmentofRateandResidueDeclineData D P  (# (# 0  0` (#(# OPPrecognizesthatinsomecasesitmaybeadvantageoustosimultaneouslyadjustmaximumrate/minimumPHIfieldtrialvaluesforbothtypicallowerthanlabelapplicationratesandtypicallongerthanlabelPHIs.Intheseinstances,thetestsponsorshouldconsiderperformingfieldtrialsinwhichbothapplicationrateandresiduedeclineinformationissimultaneouslycollected.Thisinformationonboththeeffectsof  applicationrateandresiduedeclinewithtimecanthenbecombinedandanalyzedusingmultiplelinearregressiontechniquesandcouldbeusedtoadjusttheoriginalfieldtrialdataforanycombinationofuserateandPHI. ` Infact,thisinformationcouldalsobeusedtomathematically testoutavarietyofratePHIcombinationstodeterminewhichcombinationsaremostadvantageousintermsofminimizingrisk(ormaximizingriskreduction)consistentwithprudentagriculturalpractices.Thus,fromaresourcestandpoint,sponsorsmaywanttoconsiderperformingfieldtrialsinwhichbothapplicationrateandPHIarevariedsimultaneouslyandusemultiplelinearregressiontodeterminebridgingfactors(forapplicationrate)andresiduedeclinefactors(forPHI). ` (#` (#     0  0` (#(#  4.0 ` (#` (#FieldTrialRequirementsforPesticidesWithVariousChemical  and/orPhysicalForms %  (# (# 0  0` (#(# Therelationshipbetweenresiduelevelandapplicationratemayvaryamongchemicalformsoftheactiveingredient(e.g.,theacid,salt, `  andesterchemicalformsofagivenpesticide);arepresentativeofeachmajorchemicalformoftheactiveingredientshouldbecomparedforseveralrepresentativecropstodetermineifthereisaneffectofchemicalformontherelationshipbetweenapplicationrateandresiduelevel.Therelationshipmayalsovaryamongformulationclasses(andotheraspectsoftheusepatternassociatedwiththeapplicationoftheseformulations),forexample,emulsifiableconcentrates(EC),wettablepowders(WP),granulars(G),dusts(D),ormicroencapsulated(Mcap)formulations.OPPhasdividedtheseintogroupsofformulationclassesbasedonpotentialdifferencesintheresidue/raterelationship: ` (#` (# L .7L_ckyy(L .3      ` .3/*23  0   Solidformulationsnotdiluted(e.g.,DorG);.3/*r*݌ (# (# Ќ   .3      ` .3/+23  0   XHXXXHFormulationsdilutedwithwater(e.g.,WPorEC);#XHXXXH+#.3/+r+݌ (# (# Ќ   .3      ` .3,23  0   XHXXXHFormulationsdilutedwithoil/organicsolvents(e.g.,ECorinvert  emulsions);#XHXXXH-#.3,,݌p (# (# Ќ   .3      ` .3 .23  0   XHXXXHMicroencapsulatesortimereleaseG#XHXXXH.#..3 .L.݌` (# (# Ќ  L .7L_ckyyy.7L_ckyL#+#P .7L_ckyxy.7L_cky;/P0  0` (#(# Theresiduedeclinetrialsshouldbeconductedinseparatelocations,asdescribedinthisdocument,foramajorchemicalorphysicalformineachformulationclassgrouplistedabove.TheAgencywillconsiderargumentsforlessernumbersoftrialsdependingonmarketshare.Ifanyregistrantorinterestedpartyisuncertainabouttranslatingresiduedatafromoneformulationtoanother,theseconcernsshouldberaisedwiththeAgencypriortoinitiationoffieldtrials. 0` (#` (# _  VII._0  References 32(#(# XHXXXHU.S.EPA.1996."ResidueChemistryTestGuidelinesOPPTS860;"August1996.http://www.epa.gov/docs/OPPTSHarmonized/860ResidueChemistry_ p Test_Guidelines/3#XHXXXH2#XHXXXHԀ(EPA712-C-96-169)#XHXXXH3# `  U.S.EPA1998a."GuidanceforSubmissionofProbabilisticHumanHealthExposureAssessmentstotheOfficeofPesticidePrograms;"draftdocument.November4,1998.&%XXH4O  5  http://www.epa.gov/fedrgstr/EPA-PEST/1998/November/&%%&Day-05/p29665.htm#XHX%&4##XHXXXHn5#64O5(#  715ԀXHXXXH(63FR59780)#XHXXXH>6#XHXXXH.#XHXXXH6#  p  U.S.EPA1999a. DataforRefiningAnticipatedResidueEstimatesusedinDietaryRiskAssessmentsforOrganophosphatePesticide;"draftdocument.March26,1999.XHXXXHԀ @  4|reO  5  http://www.epa.gov/fedrgstr/EPA-PEST/1999/April/Day-07/6033.pdf67O7due  7re 8Ԁ(#XHXXXH7#XHXXXH64FR16967).#XHXXXH8#XHXXXHԀ 0  #XHXXXH%9#U.S.EPA1999b.XHXXXH GuidancefortheConductofBridgingStudiesforUseinAcute  DietaryProbabilisticRiskAssessment;draftdocument.July29,1999.#XHXXXH9#XHXXXH  4OhoO  5  http://www.epa.gov/fedrgstr/EPA-PEST/1999/August/Day-04/p20042.htm6:O:(#   7(#:Ԁ(64FR  #XHXXXHr:#XHXXXH42372#XHXXXH;#XHXXXH).#XHXXXH<#XHXXXH  #XHXXXH]<#XHXXXHU.S.EPA1999c."GuidancefortheConductofResidueDeclineStudiesforUsein p AcuteDietaryProbabilisticRiskAssessment;"draftdocument.#XHXXXH<#XHXXXHJuly29,1999.#XHXXXH=#XHXXXHԀ ` 4HraO  5  &%XXHhttp://www.epa.gov/fedrgstr/EPA-PEST/1999/August/Day-04/p20042.htm6 >O4>or  7rab>Ԁ#XHX%&l>#(64FR#XHXXXH=#XHXXXH42372#XHXXXHz?#XHXXXH).&%XXH#&%%&?#&%%& P #&%%&$@##XHX%&?#U.S.EPA1999d."MemorandumfromMargaretStasikowski,DirectorHealthEffectsDivisiontoHealthEffectsDivisionStaff."ClassificationofFoodFormsWithRespecttoLevelofBlending.HEDStandardOperatingProcedure99.6(8/20/99);"August20,1999.U.S.EPA1999e."TheRoleoftheUse-RelatedInformationinPesticideRiskAssessmentandRiskManagement;"draftdocument.June29,1999.4reO  5  http://www.epa.gov/fedrgstr/EPA-PEST/1999/July/Day-14/p17318.htm62BOFBdue  7retBԀ(64FR37977). !    `     h      p    @)$'      `   /(XXHAppendices#XHX/( D#   D  XXHAppendix1:0 ExampleAnalysisofBridgingDataand @ GenerationofAppropriately-WeightedInputResidueFileforProbabilisticAnalysis  (# (# Appendix2:0 ExampleAnalysisofResidueDeclineData %H! andGenerationofAppropriately-WeightedInputResidueFileforProbabilisticAnalysis #($! (# (# #_XHXNXXH  _`  Appendix10 ExampleAnalysisofBridgingDataandGenerationof  AppropriatelyWeightedInputResidueFileforProbabilisticAnalysis ?#XHXN?#0 (# (#  Introduction  8 Inanattempttorefineresidueestimatesaspartofaprobabilisticassessment,aregistranthasconductedtworeducedusefieldtrialswithbellpeppers.OnesidebysidecroptrialwasconductedinWashington(WA)whiletheotherwasconductedinVirginia(VA).Thelabelpermitsapplicationratesoffrom1.0to2.0lbai/Aappliedthreedayspriortoharvest.Eachofthetworeducedusefieldtrialswereconductedat2.0lbai/a,1.5lbsai/A,and1.0lbsai/A(theserepresentrelativeapplicationratesof1.0x,0.75x,and0.5x,respectively)withthreecompositesamples(24individualitemspercomposite)collectedateachratefromeachtrial(withathreedaypreharvestintervalor PHI).Atotalof18compositesampleswereanalyzed.DataobtainedbyOPPindicatethat25%oftheU.S.bellpeppercropistreatedwiththepesticideofinterest.Ofthebellpeppercropthatistreated,20%istreatedatthe1.0lbai/Arate,50%istreatedatthe1.5lbai/Arate,and30%istreatedatthe2.0lbai/Arate.Theresultsfromtheregistrantstworeducedusefieldtrialsareasfollows:*g$hdd( dd"( @dd"@dd"?$@(#(#_,dd ,dd +  4  24zXXHRate l (lbai/A) U@+6"2 2UResidueLevel l (ppm) YD+6"2 Y Washington dZ.D" @2.0@dzz 2.0#zzAH# H>3" @2.0 @ Hzz0.2,1.4,1.3#zzH# H>" ?1.5?Hzz1.5#zzlI# H>3 P" ?1.5 ? Hzz0.9,1.0,0.7#zzI# H> P " ?1.0?Hzz1.0#zzJ# H>3^!!" ?1.0 ? Hzz0.6,0.7,0.6#zzK# @+^!"" @@& Virginia dZ." # @2.0@dzz 2.0#zz3L# H>3$j$" @2.0 @ Hzz1.1,1.3,1.6#zzL# H>$j%" ?1.5?Hzz1.5#zz]M# H>3x% &" ?1.5 ? Hzz0.9,1.0,1.3#zzM# H>x% '" ?1.0?Hzz1.0#zzN# H>3&&"(" ?1.0 ? Hzz0.6,0.7,0.9#zzO##XHXzF#"&&")"  " *** ($* ___________  *%,"  Step1   Giventheresultsofthefieldtrialspresentedinabove,OPPwouldconductexploratorydataanalysestoensurethattherearenotsystematicdifferencesbetweentheresidueresultsfromeachofthetwolocations.ThiswouldincludetestsforhomogeneityofvariancetoverifythattheassumptionsforlinearregressionaresatisfiedA:0 `   '  i      . P  m!89)%`|15B ` A Ee B B 0  m (#(#Aplotofrelativeapplicationratevs.relative 0    residuelevelisshowntotheright.  Specifically,therelativeresiduelevel(i.e., `    residueconcentrationatanygiven  applicationratedividedbytheaverage  residueatthattrials1xrate)isplotted  againstrelativeapplicationrate(i.e.,the     applicationratedividedbythemaximum  applicationrate).Wewouldnotethatthereis  noindicationofsystematicdifferences    betweenresiduesgeneratedintheWAtrials  andresiduesgeneratedintheVAtrials(as  indicatedbyXsandboxes,respectively)  '  ii      . p   Wenotethatthereappearstobeatrend(as  expected)towardincreasingresidueswith  (#(#increasingapplicationrate.***_______________  `  Step2   GiventheresultsofthefieldtrialspresentedintheintroductionandtheresultsofthepreliminaryanalysesinSTEPS1and2,_HED_Ԁwouldverifythatdatafromthereducedusefieldtrialstudiescanbelegitimatelycombined.Thiswouldbedonebyconductingalinearregressionandanalysisofvariance(ANOVA)withthefollowingequation:h:w2"`x < `E _ -dde > h   (#(#@___ (#(#  p!Y<,(`~0  ``E6lJMpp!}<,(`~1 X `EHTCpwhereCrelistherelativepesticideconcentration(comparedtothe1xrate)oisthey @  intercept,1istheslope(andrepresentstheincreaseintherelativeconcentrationgiven 0   TT(#(#anincreaseintherelative TUTUTT TTTUTUapplication),2isthecoefficientof   TUTUTT TTTUTUtheindicatorvariable STATE(a0 TUTUTT TTTUTU1variablesignifyinglocation TUTUTT TTTUTUeitherWA(0)orVA(1)),3isthe   TUTUTT 66TUTUcoefficientfortheinteraction 676766 666767term,and istheerrorterm.The 676766 666767linearregressionresultsforthe 676766 666767sampledataareshowninthe 676766 666767 AnalysisofVarianceand 676766 666767 ParameterEstimatesblocksto 676766 666767theright. 6666 (#(#66Todetermineifthetworegressionsdiffer,thenullhypothesisthat2=3=0istested P againstthealternativethat2and3arenotbothequalto0.Thisisappropriately @ performedbyusingthepartialFtest.Thecalculationisasfollows: 0 g:/` p  `Ek"xYd! Yg (#(#     (#(# ,`'* Їp!<,(`~1 `EV  z cpTocontrolalphaat0.05(forexample),werequireF(0.95,2,14)=3.7.SinceF=3.7>F*=0.838,thereisnoreasontoconcludethatthetworegressionfunctionsaredifferent(thiscanalsobedonewithaSequential(Type1)testshownintheboxlabeled Sequential(Type1)Testsbelow.Thisanalysisindicatesthatrelativeresidues do   increasewithincreasingapplicationrate,butthattherelativerateofresidueincreaseis not significantlyimpactedbythelocation.  '  iii     Thus,theregressionanalysiscanbe `     (#(#performedlegitimatelyafter              removingthelocation(2)and @                interaction(3)termsand,in 0                effect,adoptingasingle              (uniform)valueforthe              relativerateofincreasein              residueconcentration. (#(#  ***_____________ XHXXXHStep3   InSTEP2,itwasfoundthatthelocationandinteractionterms(2and3intheregression p equation)werenotsignificantandcouldbeeliminatedfromtheregressionequation.Giventhisresult,theregressionequationwouldberewrittenasfollows:h:2"`x* A< `E add> @ h (#(#(#(##XHXXXH]j# [      c  (#(#(#(#p!<,(`~1 1b ` \EbMp (#(#   0    `     h   p!< ,(`~1L `ECTLL { p (#(#p!R< ,(`~1r `?E3rrY  p Notefromthe ParameterEstimates  blockforthisnewregressionformula  thatthe tratioforRelRate(1)is    significant(p<0.0001)whichconfirms  thatresiduesdoincreasewith  increasingrelativeapplicationrate.  (#(#Importantly,theparameterestimateforRel.Rate(1)is0.9633.Thisistheestimatefor @  therelativeincreaseinresiduethatwilllaterbeusedtoadjusttheresiduesobtained YY(#(#fromthefieldtrialdata.From #(##(#YY YY#(##(#theFratioof0.1781inthe #(##(#YY YY#(##(# LackofFitblock(p=0.6790), #(##(#YY YY#(##(#thereisnoreasontoconclude #(##(#YY YY#(##(#thatthelinearmodeldoesnot #(##(#YY YY#(##(#adequatelydescribethedata. YYYY YYYYAtthispoint,OPPwould #(##(#YY YY#(##(#examinegraphicalplotsofthe #(##(#YY (#(##(##(#residualsagainsteitherthefittedvaluesortheapplicationratepredictorvariabletoconfirmthatnopatternswereevident.OPPwouldalsoproduceanormalplotandaboxplotoftheresidualstoverifythattheresidualshadanapproximatelynormaldistribution(seeFigureA.11).Alloftheseplotsshouldsupporttheappropriatenessoftheregressionmodelforthedata.p!< ,(`~17 `Ekg 0C} p   (#(#NotethatifthetratioforRel.Rate  ! !      ! !fromthe ParameterEstimates  ! !      ! !block(orinthiscasetheequivalent  ! !      ! !Fratiofromthe Analysisof  ! !      ! !VarianceBlock)werenot  ! !      ! !significant,OPPcouldconclude  ! !   (#(# ! !thatthereisnostatisticallysignificantrelationshipbetweenrelativeresiduelevelandapplicationrate.Inthissituation,theresiduedataprovidedbythisstudymightnotbe ! usedandtheprobabilisticanalysisconductedbyOPPcouldreverttousingtheresiduedataobtainedfromthemaximumrateandminimumPHIbellpepperfieldtrialsoriginallydevelopedtoestablishthetolerance.Informationon typicalapplicationratesmightnotbequantitativelyincorporated.AsimilarconclusioncouldbereachediftheFratiointhe LackofFitblockweresignificant:inthiscase,OPPcouldconcludefromthesedatathattherewassufficientevidenceagainstthehypothesisofalinearrelationshipbetweenapplicationrateandresiduelevelandthatitwouldbeinappropriatetoincorporatethisinformationintoaprobabilisticanalysisandalternativemeansofanalysisshouldbepursued.  0*%( _p!f< ,(`~0YB `"DE5 BB | p   (#(#                                                                                                    p!< ,(`~0e  ` E   U0 p        `   (#(#   0   "    (#(#                  `   (#(#   0     (#(#                                 p!< ,(`~0BAL `E"ALAL"p       (#(#@f f FigureA.11GraphicalPlotsofBridgingStudyData_Analysis  0*%(  Step4   Initially,atotaloffivemaximumrate/minimumPHIfieldtrialswasperformedtoestablishtolerances;duringthesetrials,atotalof10compositebellpeppersamples(i.e.,twoper  trial)wascollectedandanalyzed  '  iv     .AsperOPPguidelines,thetrialswereconductedin p theappropriategeographicregionsandintheappropriatenumberssuchthattheyareadequatelyrepresentativeofnationalproduction.Theresultswereasfollows:*x$d ddd dd g$h(#(#x,dd ,dd +  4 0  24zXXHTrial U@+  "2 2UResidueLevel    (ppm) _U+^  "2  ?1?__1_ F<1 "  ?1 ? Fzz1.8,1.4#zz# F< "  @2@F_2_ F<1j "  @2 @ Fzz0.8,1.2#zz# F<j "  @3@F_3_ F<1x "  @3 @ Fzz1.8,1.6#zz# F<x "  @4@F_4_ F<1&"  @4 @ Fzz1.4,1.5#zzw# F<&"  @5@F_5_ F<14"  @5 @ Fzz1.4,1.8#zzn##XHXz-#"4"  "  Asaresultofthenewlysubmittedreducedusefieldtrials,theAgencyhasdetermined(see ParameterEstimatesblockinSTEP3)thattheappropriaterelationshipbetweenrelativeresiduelevelsandrelativeapplicationrateisasfollows:h:2"`x B< `E dd> ;h   (#(# (#(#     Thisistherelationshipthatwouldbeusedtoadjusttheresultsfromthetencompositesamplesfromthefivemaximumrate/minimumPHIfieldtrialsconductedearliertoestablishtolerances(andlistedabove)totheresultsthatwouldbeexpectedtooccurattherangeofmoretypicalapplicationrates.Asanexample,ifoneofthemaximumrate/minimumPHIresiduevaluesfroma1xapplicationrateof2lbai/Awas1.8ppm(asinTrial1above),thisvaluewouldbeadjustedtoa1.5lbai/A(0.75x)ratebymultiplyingthe1.8ppmvalueby0.963x0.75andadding0.030.Thiswouldproduceanadjustedresiduevalueof1.33ppm.Eachofthetenmaximumrate/minimumPHI1xvalueswouldbeadjustedinthismannertoyieldacollectionoftenresiduevaluesappropriatefora0.75xrate.Asimilaroperationwouldbeusedtoadjustthesametenmaximumrateresiduevaluestoa0.5x(or1.0lbai/A)rate(whichinthecaseofthe1.8ppmvaluewouldproduceanadjustedresiduelevelof0.90ppm).Inthismanner,OPPwoulddevelopfromthe10compositesamplesoriginallycollectedfortolerancesettingpurposes,aseriesoftencomparableresiduevaluesthatwouldreflectexpectedresiduesata0.75xrateaswellasaseriesoftenresiduevaluesreflectiveofexpectedresiduesatthe0.5xrate.Theseareillustratedbelowforthesampledata:*x$ dddd dd $(#(#x, dd ,Ndd ,Ndd ,Ndd +  8#  28zXXHTrial fQ<T" 2 2fResidueLevels(ppm) YD+"2 2YAdjustedResidue T Levels(ppm) >4."2 > 6!  261x U@+F"2 2U0.75x U@+F"2 2U0.5X _U+F"2  ?1?_1 F<1T"  ?1 ? Fzz1.8,1.4#zz1# 'T" 'zz1.33,1.04#zz# 'T" 'zz0.90,0.70#zz# F<T"  @2@F_2_ F<1"  @2 @ Fzz0.8,1.2#zz# ' " 'zz0.60,0.89#zz# '!" 'zz0.41,0.60#zz# F<""  @3@F_3_ F<1`#"  @3 @ Fzz1.8,1.6#zz# '`$" 'zz1.33,1.18#zz]# '`%" 'zz0.89,0.80#zzМ# F<`&"  @4@F_4_ F<1n'"  @4 @ Fzz1.4,1.5#zzɝ# 'n(" 'zz1.04,1.11#zz:# 'n)" 'zz0.70,0.75#zz# F<n*"  @5@F_5_ F<1+"  @5 @ Fzz1.4,1.8#zz# '," 'zz1.04,1.33#zz# '-" 'zz0.70,0.89#zz##XHXz:#"."  "  Usingtheseriesofadjustedresiduevaluesthatcorrespondtothoseapplicationratesforwhichusedataexist,itnowbecomesnecessarytoinsertthesevalues(inthe !0 appropriateproportions)intoaprobabilisticassessment.Itiscritical,forexample,thatif "1 only6%ofthecropistreatedatthemaximumrate,thatthereonlybea6%probabilityofselectingaresiduevaluethatreflectsthisrate.  f% 4   TheAgencyhasdeterminedfromavailableusedatathatonly25%ofthebellpeppercropistreatedwiththepesticideofinterest(asoriginallystatedintheintroductorysectiontothisexample).Ofthosebellpeppersthataretreated,20%aretreatedatthe1.0lbai/Arate,50%aretreatedatthe1.5lbai/Arate,and30%aretreatedatthe2.0lbai/Arate(theserepresentthe0.5x,0.75x,and1xrates,respectively).Thus,themaximumrate/minimumPHIfieldtrialdataconductedearlierfortolerancesettingpurposeswillbeadjustedtoaccountforthelowerresiduelevels(asdeterminedinSTEP3andrepeatedinSTEP4)intheappropriateproportions(as 0  determinedbypercentcroptreatedandtreatmentratedatapresentedintheintroductorysectiontothisexample).Giventhisinformation,20%,50%,and30%of `  thetreatedcommodityinputfiletoanyMonteCarloanalysiswouldberequiredto P  containdatarepresentativeofthe1,1.5,and2lbai/Atreatmentrates,respectively.Inaddition,theMonteCarlofileshouldbeconstructedsuchthatthereisonlya25%probabilityofselectingatreatedcommodity(andthusa75%probabilityofselectinganuntreatedcommoditywithconsequentresiduelevelsofzero).  Todothis,thetenoriginalresiduevaluesrepresentingthe1xratefromthemaximumrate/minimumPHItolerancefieldtrialswouldeachbeenteredintotheMonteCarlofilethreetimes,thetenadjustedresiduevaluesrepresentingthe0.75xratewouldeachbeenteredfivetimes,andthetenadjustedresiduevaluesrepresentingthe0.5xratewouldeachbeenteredtwiceinordertoprovidetheappropriate3:5:2ratioforthe1x,0.75x,and0.5xapplicationrates6  '  v      .Thiswouldproduceafilewithatotalof100 P positiveresiduevaluesandwouldrepresentthenumberof nonzeroesinthefile.Toincorporatethenontreatedfractionofthecommodity(i.e.,thatportionwithresidue 0 valuesoftruezero),300 zerovalueswouldalsobeentered.Thus,therewouldbeatotalof400potentialzeroornonzeroresiduelevelsfromwhichtoselect,ofwhich300(or75%)representzeroforthenontreatedcommodities,and100(or25%)representtreatedcommoditiesinproportionsappropriatetoreflectthe3:5:2ratiosforthe2.0,1.5,and1.0lbai/Atreatmentrates,respectively.  Theresultsofthisanalysisareshowninthetableonthefollowingpagewithexposures(asestimatedbyDEEM)software)shownforthegeneralU.S.populationandchildrenonetosixatthe99.9th,99th,and95thpercentilesforconsumersonly. #!  `'"% Ї*$d d dd Ndd NNdd NNdd N$(#(#,'dd",dd",dd",dd",dd",dd",dd"+  8#  28zXXHMethod jU<4"uu+2 2jDEEMestimatedExposure(consumersonly)!mg/kg/day 4 (RelativeExposurea) >4."2 > :%   2:GeneralU.S.Population \G. \"2 2\ChildrenOnetoSix >4. \"2 > 6!  V 2699.9th U@+j  "2 2U99th U@+j  "2 2U95th U@+j  "2 2U99.9th U@+j  "2 2U99th U@+j  "2 2U95th @6+j "2 @AssumingTreatmentat1xrateofTreatedCrop '&v " '0.0229(1.00) ' " '0.00830(1.00) ' " '0.00089(1.00) ' " '0.02986(1.00) ' " '0.01437(1.00) ' " '0.00233(1.00) ' " 'ProbabilisticTreatmentofDistributionofTreatmentRates(1x,0.75x,and0.5x) 'v$" '0.01843(0.81) 'N &" '0.00638(0.77) 'N (" '0.00067(0.75) 'N *" '0.02484(0.83) 'N ," '0.01116(0.77) 'N ." '0.001807(0.77) +!N 0" +aExpressedrelativetoestimatedexposureassumingallapplicationsoccuratlabelmaximumrate.#XHXz#%$1   %  Ascanbeseenintheabovetable,theprobabilisticuseofafulldistributionoftreatmentrates(i.e.,1x,0.75x,and0.5x)resultsinlowerestimatedexposuresthan 3 wouldbecalculatedassumingthatallapplicationratesoccurexclusivelyatthelabelrate.Atthe99.9thpercentileforthegeneralU.S.population,forexample,the 5 probabilistictreatmentofapplicationrates,resultsinanestimatedexposureatthe99.9thpercentilethatisonly81%ofthatexposurethatwouldhavebeenestimated n7 withoutthisprobabilistictreatment.Forchildrenagedonetosix,thecorrespondingpercentageis83%.Thus,theincorporationofadistributionoftreatmentratesintotheexposureandriskassessmentcanresultinsignificantlyreducedexposureestimates. REFERENCE  "^= U.S.EPA1998. GuidanceforDataQualityAssessment:PracticalMethodsforDataAnalysis;EPAQA/G9QA97Version.OfficeofResearchandDevelopment.̀4omO  5  http://www.epa.gov/r10earth/offices/oea/epaqag9.pdf6Oexa  7sTԀ(EPA/600/R-96/084) %!A   (#D  ` r _NXXH  Appendix_Ԁ20 ExampleAnalysisofResidueDeclineDataand  GenerationofAppropriatelyWeightedInputResidueFileforProbabilisticAnalysis  (# (#  #XHXN# Introduction  8   Inanattempttorefineresidueestimatesaspartofaprobabilisticassessment,aregistranthasconductedtwofieldtrialssamplingbellpeppersatvarioustimesfollowingpesticideapplication.OnesidebysidecroptrialwasconductedinORwhiletheotherwasconductedinDE.Thelabelpermitsapreharvestinterval(PHI)ofthreedays.Sampleswerecollectedatone,two,three,five,andsevendaysfollowingapplication.Threecompositesamples(24individualitemspercomposite)werecollectedateachPHIfromeachtrial.Atotalof30compositesampleswasanalyzed.  OPPdataindicatethatofthebellpeppercropthatistreated,20%isharvestedthreedaysfollowingapplication(i.e.,atthelabelPHI),30%isharvestedfivedaysafter 8 application,andtheremaining50%isharvested10daysfollowingapplication.Theyhavefurtherestimatedthatonly25%ofthebellpeppercropistreated.  Theresultsfromtheregistrantstwofieldtrialsareasfollows:XHXXXH*$ dd'dd"'dd"dd"dd"dd"dd"dd"$(#(#, dd ,dd +  4 ( 24zXXHPHI(day) U@+<"2 2UResidueLevel(ppm) P;+<"2 P  Oregon g].  m ?1?g_#zz#zz  1_ F<1H"  ?1 ? F#zz#zz3.1,3.0,2.7#zz1#zz KAH" m  @2@K#zz#zz2 F<1e"  @2 @ F#zz#zz2.8,2.4,2.3#zz#zz F<e"  @3@F#zz#zz3 F<1"  @3 @ F#zzn#zz2.5,2.4,2.1#zz#zz F<"  @5@F5 F<1! q"  @5 @ F2.1,1.8,1.7#zzF#zz F<! q "  @7@F7 F<1!!"  @7 @ F#zz"#zz1.7,1.5,1.3#zz#zz @+!"" @@NN$ Delaware bX."-#  ?1?b#zz@#zz1 F<1;$$"  ?1 ? F#zzE#zz5.9,5.6,5.2#zz#zz F<;$%"  @2@F#zz#zz2 F<1% &"  @2 @ F#zz#zz5.5,5.3,4.8#zz/#zz F<% '"  @3@F#zz#zz3 F<1&G"("  @3 @ F#zz#zz4.7,4.7,4.1#zz#zz F<&G")"  @5@F5 F<1U(#*"  @5 @ F4.0,3.7,3.5#zz#zz F<U(#+"  @7@F_7_ F<1)%,"  @7 @ F3.2,2.4, 2.7#zz#zz")%-" "#zz#*** ___________ A,'/ XHXz $ ` p!I<,(`~1  ` Eu  *IZ p **(#(#Step1     **** ****  Giventheresultsofthefieldtrials *+*+** ***+*+presentedinabove,OPPwouldconduct *+*+** ***+*+exploratorydataanalysisandhypothesize *+*+** ***+*+asapreliminaryassumptionthatresidue *+*+** ***+*+declineisfirstorderwithrespectto *+*+** ***+*+concentration.Thisexploratorydata *+*+** ***+*+analysiswouldalsoincludetestsfor *+*+** ***+*+homogeneityofvariancetoverifythatthe *+*+** ***+*+assumptionsforlinearregressionare *+*+** ***+*+satisfied.Specifically,priortoperforming *+*+** ***+*+thelinearregressionanalysistoestimate *+*+** ***+*+theresiduedeclineratesinORandDE,it *+*+** ***+*+wouldbenecessarytoverifythatthe *+*+** (#(#*+*+variancesdonotdiffersignificantlyamongtheresiduevaluesacrossPHIsandtrials(i.e.,totesthomogeneityofvariance).K  '  i        Aplotofthenaturallogarithmofresidue(lnres)vs.PHIisshownabove.Thelower  curverepresentsresiduedeclineinORwhiletheuppercurverepresentsdeclineinDE.Theredoesnotappeartobeanyindicationofsystematicdifferencesbetweenresiduedeclineratesbetweenthesestates(i.e.,theslopes,representingthedecayrates, ` appeartobesimilar)-  '  ii      .Furthermore,thereisastatisticallysignificanttrend(as P expected)inbothtrialstowarddecreasingresidueswithincreasingPHIasevidencedbythePHIcoefficientsof0.1092day1and0.1171day1(pvalueof<0.001)fortheOR 0 andDEsites,respectively:   `     h      p      x     `   0 DESite:  p!A<,(`~1L `mEYLLep (#(#(#(# (#(#(#(#ORSite: 0  p!i<,(`~1L `mE LLe_ p (#(#(#(# (#(#(#(#***____________________ Step2   Giventheresultsofthefieldtrialsandtheresultsofthepreliminaryanalysispresentedabove,OPPwouldtypicallyverifyifdatafromtheresiduedeclinestudiescouldbelegitimatelycombined.ThiscouldbedonebyconductingalinearregressionandAnalysisofVariance(ANOVA)withthefollowingequation:h:S^2 "`x;< `E dd ># h 2(#2(#(#(# (#(#2(#2(#p!<,(`~1 ` \E$!7!Mpwhereoisthenaturallogarithmoftheyintercept(Co),1istheslope(andrepresentsthe 0  (#(#firstorderdecayrate),2isthecoefficientof     theindicatorvariable STATE(a01variable  signifyinglocationeitherDE(0)orOR(1)),  and3isthecoefficientfortheinteractionterm. #!   Thelinearregressionresultsforthesample  dataareshowntotherightandbelowinthe   SummaryofFitand ParameterEstimates  blocks. `'"% p!J<,(`~1 `_EC{p (#(#  Wenotefromthe Parameter  Estimatesblocktotherightthatthet  ratioforPHI(1)issignificant(t=    10.99;p<0.001)whilethetratiofor  the3interactionterm(t=0.53,p p   =0.6027)isnot  '  iii     .Thisindicatesthat `    residues do declinewithincreasing P    (#(#PHIbutthattherateofresiduedeclineis not significantlyimpactedbythelocation.  '  iv      @  Thus,theregressionanalysiscanbelegitimatelyperformedafterremovingthis 0  interactiontermand,ineffect,adoptingasingle(uniform)valuefortherateofresiduedecline.***_____________ Step3     Sinceweconcludedabovethattheinteractionterm(3intheaboveregression  equation)wasnotsignificantandcouldbeeliminatedfromtheregressionequation,theregressionequationwouldberewrittenasfollowstoexcludethenonsignificantinteractionterm:h:q{2"`xD< `E ' dd_ >, ` th (#(#(#(# `(#(# p!d<,(`~0 ` \E$eMp (#(#p!=<,(`~0P  `EC{p   Notefromthe SummaryofFitblock  and ParameterEstimatesblockforthisnew  regressionformulathatcorrelationcoefficient  of0.961demonstratesthatasubstantial  amountofthevariationinresiduesis  explainedbythePHI,andthetratioforPHI  (1)issignificant(p<0.001),whichconfirmsthat P    (#(#residuesdeclinewithincreasingPHI.Importantly,theparameterestimateforPHI(1)is @  Є0.1132.Thisistheestimateforthecommonfirstorderdecayconstantforthetwotrials(i.e.,thevaluefor1intheaboveequation)thatwilllaterbeusedtoadjustthe  p   (#(#residuesobtainedfromthefieldtrial  data.FromtheFratioof0.2759in  the LackofFitblock(p=0.9562),  thereisnoreasontoconcludethat  thefirstorderdecaymodeldoesnot  adequatelydescribethedata. h        `     (#(#p!<,(`~0r `?ErrQp  Atthispoint,itwouldbeappropriatetoexaminegraphicalplotsoftheresidualsagainsteitherthefittedvaluesorthePHIpredictorvariabletoconfirmthatnopatternswereevident.Anormalplotandaboxplotoftheresidualsmightalsobeproducedto (#(#verifythattheresidualshadan  approximatelynormal  distributionandaShapiroWilk  testfornormalitycouldbe  conductedforconfirmationof  residualnormality.Allofthese  plotsandstatisticsshould  supporttheappropriatenessof  theregressionmodelforthe  (#(#data.TheseplotsandstatisticsareillustratedinFigureA.22.p!<,(`~1Q `Ed!"!Cpp!<,(`~08" `E{8"0!Cp      IfthetratiosforPHIfromthe ParameterEstimatesblock(orinthiscasetheequivalentFratiofromthe AnalysisofVarianceBlock)werenotsignificant,therewouldbenostatisticallysignificantrelationshipbetweenresiduelevelandPHI.Inthiscase,theresiduedeclinedataprovidedbythisstudymightnotbeusedandthe p probabilisticanalysisconductedbyOPPcouldreverttousingtheresiduedataobtainedfromthemaximumrateandminimumPHIbellpepperfieldtrialsoriginallydevelopedtoestablishthetolerance.Informationon typicalPHIs,inthisinstance,mightnotbeincorporated,andanalternatemethodmightbesought.AsimilarconclusioncouldbereachediftheFratiointhe LackofFitblockweresignificant:inthiscase,OPPcouldconcludefromthesedatathattherewassufficientevidenceagainstthehypothesisoffirstorderdecayofresidueswithtimesuchthatitwouldbeinappropriatetoincorporatethisintoaprobabilisticanalysisandalternativemeansofanalysisshouldbepursued.   p!1<,(`~0 > `}EN >> ep   (#(#                                                                            (#(#     (#(#          p!3<,(`~0 Pb  `b E< b b  p                                                                         p!F<,(`~0 nAL `E#ALAL"p  (#(#  FigureA.21GraphicalPlotsofResidueDeclineStudyDataAnalysis  0*%( S Step4     Previously,atotaloffivemaximumrate/minimumPHIfieldtrialswasperformedtoestablishtolerances;duringthesetrials,atotalof10compositebellpeppersamples(i.e.,twopertrial)wascollectedandanalyzed_  '  v     _.Asper_HED_Ԁguidelines,thetrialswere `  conductedintheappropriategeographicregionsandintheappropriatenumberssuchthattheyareadequatelyrepresentativeofnationalproduction.Theresultswereasfollows:   `  *xM$Nhd  d dd dd $(#(#x,dd ,dd +  4 `  24zXXHTrial U@+t "2 2UResidueLevel(ppm) _U+t "2  ?1?__1_ F<1" "  ?1 ? Fzz#XHXzv #5.2,5.4#XHXXXH #zXXH F<" "  @2@F_2_ F<1V "  @2 @ Fzz#XHXz5 #2.8,3.2#XHXXXH #zXXH F<V "  @3@F_3_ F<1*"  @3 @ Fzz#XHXzn #1.8,1.6#XHXXXH:#zXXH F<*"  @4@F_4_ F<1^"  @4 @ Fzz#XHXz#1.4,1.5#XHXXXHs#zXXH F<^"  @5@F_5_ F<12"  @5 @ F#XHXz#XHXXXH1.4,1.8#XHXXXH#"2"  "   `    Asaresultoftheresiduedeclinefieldtrials,OPPhasdeterminedpreviously(inSTEP3)thattheappropriateestimateforresiduedecline(throughafirstorderdecayprocess)is0.1132day1.Thus,theappropriateequationtoadjusteach(original)maximum  rate/minimumPHIfieldtrialvalueisasfollows:j: 4$ `x c `E fdd4T  'j J(#J(#(#(# (#(#J(#J(#whereCt=_minPHI_istheresiduevaluetobeadjusted(i.e.,theresiduesampledatthe b   minimumlabelPHIintheoriginalfieldtrials),2istheresiduedeclineconstant R!! determinedpreviously,and nisthenumberofdaysfollowingapplicationatwhichactualharvestoccurs.ThisistherelationshipthatwouldbeusedtoadjusttheresultsfromthetencompositesamplesfromthefiveoriginalfieldtrialsconductedearliertoestablishtolerancestotheresultsthatwouldbeexpectedtooccurattherangeofmoretypicalapplicationPHIs.Asanexample,ifoneofthemaximumrate/minimumPHIresiduevaluesfroma1xapplicationrateatthelabelPHIofthreedayswas5.2ppm(asinTrial1above),thisvaluewouldbeadjustedasfollowsforgiveand10dayPHIs: '2#( Ї  6day:Ct=6days=5.2ppmxe(0.113)(63)=5.2ppmx0.7125=3.70ppm    10day:Ct=10days=5.2ppmxe(0.113)(103)=5.2ppmx0.4534=2.36ppm  Eachofthetenmaximumrate/minimumPHI1xvalueswouldbeadjustedinthismannertoyieldacollectionofresiduevaluesreflectinganydesiredPHI.Inthismanner,onewoulddevelopfromthe10compositesamplesoriginallycollectedfortolerancesettingpurposes,aseriesofcomparableresiduevaluesthatwouldreflectexpectedresiduesatvarioustimeintervalsfollowingresiduedecline.Theseareillustratedbelowforthesampledata:*x$/dhddd dd M$N(#(#x,dd ,dd ,dd ,dd +  8# P  28zXXHTrial fQ<d " F2 2fResidueLevel d  (ppm) YD+.~ "2 2YAdjustedResidueLevel d  (ppm) G=..~ "2 G 6! (x  263day U@+ "2 2U6days U@+ "2 2U10days _U+ "2  ?1?__1_ F<1:"  ?1 ? Fzz#XHXz#5.2,5.4#XHXXXH#zXXH ':" 'zz#XHXzo#3.7,3.9#XHXXXH#zXXH ':" 'zz#XHXz"#2.4,2.4#XHXXXHh#zXXH F<:"  @2@F_2_ F<1n"  @2 @ Fzz#XHXz#2.8,3.2#XHXXXH #zXXH 'n" 'zz#XHXz!#2.0,2.3#XHXXXHU!#zXXH 'n" 'zz#XHXz!#1.3,1.5#XHXXXH"#zXXH F<n"  @3@F_3_ F<1B"  @3 @ Fzz#XHXzu"#1.8,1.6#XHXXXHA##zXXH 'B" 'zz#XHXz##1.3,1.1#XHXXXH##zXXH 'B" 'zz#XHXzb$#0.82,0.73#XHXXXH$#zXXH F<B"  @4@F_4_ F<1v "  @4 @ Fzz#XHXz%#1.4,1.5#XHXXXH%#zXXH 'v!" 'zz#XHXzP&#1.0,1.1#XHXXXH&#zXXH 'v"" 'zz#XHXz'#0.63,0.68#XHXXXHI'#zXXH F<v#"  @5@F_5_ F<1J$"  @5 @ Fzz#XHXz'#1.4,1.8#XHXXXH(#zXXH 'J%" 'zz#XHXz(#1.0,1.3#XHXXXH7)#zXXH 'J&" '#XHXz)#XHXXXH0.63,0.82#XHXXXH *#"J'"  "***_____________ Step5  ,   Giventhattheseriesofadjustedresiduevalues(derivedabove)whichcorrespondtothosePHIsforwhichBEADuserelateddataareavailable,itnowbecomesnecessarytoinsertthesevalues(intheappropriateproportions)intoa "0 probabilisticassessment.Itiscritical,forexample,thatifonly5%ofthecropisharvestedfollowingtheminimum(label)PHI,thatthereonlybea5%probabilityofselectingaresiduevaluethatreflectsthisPHI.  :'"5   Inthisexample,OPPhasdeterminedthatonly20%ofthetreatedbellpeppercropisharvestedattheminimumlabelPHIofthreedays,that30%isharvestedfivedaysfollowingtreatment,andtheremaining50%isharvested10daysfollowingtreatment.Thus,themaximumrate/minimumPHIfieldtrialdataconductedearlierfortolerancesettingpurposescanbeadjustedtoaccountforthelowerresiduelevels(as p determinedbytheaboveequation)intheappropriateproportions(asdeterminedbythe `  BEADpercentcroptreatedandtreatmentratedata).Giventhisinformation,wenote P  that20%,30%,and50%ofthetreatedcommodityinputfiletoanyMonteCarloanalysiswouldberequiredtocontaindatarepresentativeofthethree,six,and10dayPHIs,respectively.Inaddition,theMonteCarlofileshouldbeconstructedsuchthatthereisonlya25%probabilityofselectingatreatedcommoditytocomplywiththeestimateof25%croptreated(andthusa75%probabilityofselectinganuntreatedcommoditywithconsequentresiduelevelsofzero).  Todothis,thetenoriginalresiduevaluesrepresentingthethreedayPHIfromthemaximumrate/minimumPHItolerancefieldtrialswouldeachbeenteredintotheMonteCarlofiletwotimes,thetenadjustedresiduevaluesrepresentingthefivedayPHIwouldeachbeenteredthreetimes,andthetenadjustedresiduevaluesrepresentingthe10dayPHIwouldeachbeenteredfivetimes  '  vi      .Thiswouldproducea  filewithatotalof100positiveresiduevaluesandwouldrepresentthenumberof nonzeroesinthefile.Toincorporatethenontreatedfractionofthecommodity(i.e., p thatportionwithresiduevaluesoftruezero),300 zerovalueswouldalsobeentered.Thus,therewouldbeatotalof400potentialzeroornonzeroresiduelevelsfromwhichtoselect,ofwhich300(or75%)representzeroforthenontreatedcommodities,and100(or25%)representtreatedcommoditiesinproportionsappropriatetoreflectthe2:3:5ratiosforthethree,six,and10dayPHIs,respectively.  `    `     h Theresultsofthisanalysisareshownbelowwithexposures(asestimatedbyDEEM)software)shownforthegeneralU.S.populationandchildrenonetosixatthe99.9th,  99th,and95thpercentiles:  *D$Wdddd dd dd dd $/(#(#,dd",dd",dd",dd",dd",dd",dd"+  8# `  d8zXXHMethod jU< "cuu7d djDEEMestimatedExposure(consumersonly)!mg/kg/day   (RelativeExposurea) >4. "d > :%   d:GeneralU.S.Population \G. < "d d\ChildrenOnetoSix >4. < "d > 6!  6  d699.9th U@+J  "d dU99th U@+J  "d dU95th U@+J  "d dU99.9th U@+J "d dU99th U@+J "d dU95th @6+J "d @AssumingHarvestofTreatedCommodityatlabelprescribedminimumPHIof3days 'V " '0.0089(1.00) 'r " '0.0024(1.00) 'r " '0.00057(1.00) 'r " '0.0138(1.00) 'r " '0.00509(1.00) 'r " '0.00116(1.00) 'r " 'ProbabilisticTreatmentofDistributionofPHIs(3,6,and10days) 'H#" '0.0054(0.61) '.~%" '0.0014(0.60) '.~'" '0.00027(0.47) '.~)" '0.00992(0.72) '.~+" '0.00325(0.64) '.~-" '0.00069(0.60) +!.~/" +aExpressedrelativetoestimatedexposureassumingharvestoccursatlabelminimumPHIof3days.#XHXz8#%V0"   %  Ascanbeseenintheabovetable,theprobabilisticuseofafulldistributionofPHIs(i.e.,three,six,and10days)resultsinlowerestimatedexposuresthanwould  p3 becalculatedassumingthatallharvestsoccurexclusivelyatthelabelPHIofthreedays.Atthe99.9thpercentileforthegeneralU.S.population,forexample,the P5 probabilistictreatmentofPHI,inthisexample,resultsinanestimatedexposureatthe99.9thpercentilethatisonly61%ofwhichitwouldhavebeenhaditbeenestimated 07 withoutthisprobabilistictreatment.Forchildrenonetosix,thecorrespondingpercentageis72%.Thus,theincorporationofadistributionofPHIsintotheexposureandriskassessmentcanresultinsignificantlyreducedexposureestimates. REFERENCE  "= XHXXXHU.S.EPA1998. GuidanceforDataQualityAssessment:PracticalMethodsforDataAnalysis;EPAQA/G9QA97Version.OfficeofResearchandDevelopment.̀4omO  5  http://www.epa.gov/r10earth/offices/oea/epaqag9.pdf6EOFexa  7sT0FԀ(EPA/600/R-96/084)#XHXXXHSO# @&!A  @&!A  @&!A  @&!A . @&!A _______  __  __  _   `     h