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WesternGrowersAssociation6
ServingtheCaliforniaandArizonaFreshProduceIndustry
June29,1998DocketsManagementBranchFoodandDrugAdministration12420ParklawnDriveRoom1-23Rockville,MD20857RE:DocketNo.97N-0451
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DearSirs:INTRODUCTIONThefollowingarethecommentsofWesternGrowersAssociation(WGA)onthedraftGuidanceforIndustry:GuidetoMinimizeMicrobialFoodSafetyHazardsforFreshFruitsandVegetables(Guide).WGAisanagriculturaltradeassociationwhichrepresentsthefreshfruit,vegetable,andnutindustryinCaliforniaandArizona.WGAS3400membersgrow,pack,shipandprocessover90%ofthefreshvegetablesandover60%ofthefreshfruitsandnutsgrown,packed,shipped,andprocessedinArizonaandCalifornia.Approximately54%ofthefreshfruits,vegetablesandnutsconsumedintheUnitedStatesareproducedbyWGAmembers.FoodsafetyisacriticallyimportantmatterforWGAanditsmembership,OurmemberspridethemselvesontheirabilitytoprovidetoUnitedStatesandinternationalconsumersthesafest,mostnutritiousandleastexpensivefreshfruits,vegetablesandnuts.WGAhasbeenontheleadingedgeoffoodsafetyactivities.WeareproudofthefactthatWGAdevelopedandpublished,inpartnershipwiththeInternationalFresh-cutProduceAssociation(IFPA),thewidelyacclaimed,disseminatedandusedVoluntaryFoodSafetyGuidelinesforFreshProduce.WGAhasbeenanactiveparticipantinallfederalandstatefoodsafetyissuesanddiscussions.
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Mailing
Address:P.O.Bo.Y2130,NewportBeach,CA92658
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StreetAddress:17620FitchSt.,Inine,CA92614(714)863-1000
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FAX:(714)863-9028
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InternetAddress:http:llw~w’.wga,com
 
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IMPORTANTCONSIDERATIONSPriortomakingspecificcommentsonthedraftGuide,wewouldliketonoteseveralveryimportantpointswhichweurgeFDAtokeepintheforefrontofitsconsiderationsastheagencyeffortsmoveforward:1.Productionagricultureisnotresponsibleforthebulkoffoodsafetyoutbreaks.AccordingtothemostrecentCenterforDiseaseControlstatistics,freshproducecontributeslessthan7?40oallfood-borneillnesses.Theoverwhelmingmajorityoffood-borneillnesses,over70°!4,arecausedbypost-harvest,post-purchasefoodhandlingpractices,mostcommonlybyuninformedconsumers.2.Virtuallyeveryhealthexpert,includingtheNationalCancerInstituteandfederalandstategovernmentexpertsandagencies,stronglyadvocatetheincreasedconsumptionoffreshfruitsandvegetablesasthesinglemostimportantstepAmericanconsumersshouldtaketopreventcanceraswellasweightproblemsandrelatedillnessessuchasdiabetes.Thebenefitsofeatingatleastfiveservingsadayoffreshfruitsandvegetablesfaroutweighanyrisksassociatedwithconsumingfoodthathasunfortunatelybecomeacarriertoamicrobialpathogen.TheextremelysignificantbenefitsofadietwhichcontainsahighpercentageoffreshfruitsandvegetablesonlybecomemoreimportantinlightoftherecentdecisionbyanotheragencywithintheDepartmentofHealthandHumanServices(HHS),theNationalInstitutesofHealth(NIH),torecommendwithinthelasttwoweeksalowerdesirableweightforAmericans(copyofNIHNewsRelease,Attachment1).IftheselowerbodyweightsaretobeachievedbylargenumbersofAmericans,itcanprobablyonlyhappenthroughgreatlyincreasedconsumptionoffreshfruitsandvegetables.Again,thepositivecontributionstooverallhealthgoalsofeatinglargeamountsoffreshfruitsandvegetablesarefarmoreimportantthantherelativelylowriskofconsumingararepieceofcontaminatedfood.ItisincumbentonFDA,asonearmofHHS,thefederalagencywithprimaryresponsibilityforthehealthoftheU.S.population,tonotsendanymessagesorgiveanynegativeindicationstotheAmericanpublicwhichcouldleadtodiminishedconsumptionoffruitsandvegetables.
WGAACTIVITIESOVERPASTYEAR
AlthoughthemembersofWGAnotewithstrongemphasisthatcontaminationoffreshproduceisonlyaveryminorcauseoffoodborneoutbreaks,WGAmembersdid,alongwithmembersofthefreshproduceindustryacrossthecountry,beginayearandahalf
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agotodevelopasetoffoodsafetyvoluntaryguidelinestofocusonfarm-levelpracticesthathavebeenconnectedtofood-borneillnesses.Thiseffortwasundertakenvoluntarilybecausetheindustrybelievesitowesittoitselfanditsconsumercustomerstodoeverythingpossibletominimizewhereverpossible,anypotentialformicrobialcontaminationoffreshproduce.Membersoftheindustryhavetakenthisstepagainstthebackdropofknowingthattheyalreadyproducethesafestfreshproduceanywhereintheworld.InadditiontoproductioninCaliforniaandArizona,WGAmembersproducealargepercentageofthefreshfruitsandvegetablesthataregrowninMexico-throughjointventuresorinpartnershipswithMexicangrowers.BecauseofthestronginterestofWGAmembersinMexico,WGAhadaSpanishversionoftheVoluntaryFoodSafetyGuidelinesprepared.ThishasbeendistributedtoMexicanstategovernmentofficialsandfreshproduceassociationsandgrowers.Further,WGAhasmetwithandwillcontinuetomeetwithproduceassociationexecutivesfromthemajorgrowingstatesinMexicotodiscuss,developandimplementcross-borderfoodsafetystrategies.
APPROACHTOINITIATIVESHOULDBERE-VAMPED,ASCURRENTAPPROACHUNLIKELYTOBESUCCESSFUL
OneofWGASstrongestcommentsregardingthedraftGuideisthatthetypeofprogramenvisionedintheGuidewillneverbesuccessfulifmandatedorstructuredasalopdownapproach-thatis,fromthefederalgovernmentdowntogrowers.Webelieveourviewonthistopicissupportedbyfindingsintherecentlyreleased(April1998)GovernmentAccountingOffice(GAO)reportentitledFoodSafety:FederalEffortstoEnsuretheSafetyofImportedFoodsareInconsistentandUnreliable.Althoughwedonotagreewithalloftheviewsorsuggestionsputforwardinthatreport,thereportdoesdoacrediblejobofillustratingtheimmensescopeofsomeoftheaspectsoftheproblemthatFDAisattemptingtoaddressintheGuide.TheGAOreport(althoughnotnecessarilyintendedtodoso)makesexceedinglyclearthatthetaskofensuringtheNationsfoodsupplyismulti-facetedandextremelycomplex.Forthisreason,itiscompletelyunreasonabletoanticipatethatafederalagency(oragencies)couldeverhaveenoughresourcestobetheprimarytooltocarryoutthetask.Instead,thereisatrulyenormousamountofeffortwhichmust,andinfactalreadyis,beacceptedbyeachandeveryprivatepartywhoisinthechainofmovingfoodfromthefieldtothetable.Thesemillionsofpersonscannotbeoverseenorcheckedastoeveryactiontheytake.-3-
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