第二稿-電子版保存外文翻譯

外文翻譯之 implementationinfoodbusinesses:theneedforaflexibleapproach作者：1.JohnE 2.GeorgeP國籍：1. 2.出處：August1995inJOURNALOFTHEROYALSOCIETYOFHEALTH,Page249—253:Thereisaconsiderableliteratureonmicrobiologicalhazardswhichcausefoodbornediseasesandillnesses,andfactorswhichinfluencetheiroccurrenceandgrowthinfoods.Similarly,stagesinthefoodchainwherefoodsmaybemishandled,andpracticeswhichoftenleadtooutbreaksoffood-bornediseasesarewelled.Althoughthesehazardsandpracticescanbecontrolledinordertopreventorminimiseriskstohealth,foodbornediseaseshavecontinuedtopresentaseriouschallengetopublichealth.Becausethetraditionalapproachesofinspectionandend-producttestinghaveprovedinadequateintacklingtheproblemoffood-bornediseases,thereisanurgentneedtoapplymorerationalandeffectivestrategies.OnesuchstrategyistheHazard ysis,CriticalControlPoints(HA )systemwhichiscurrentlyininternationaldiscussion.ThispaperexaminestheepidemiologicalbasisfortheapplicationofHAtofoodsafetycontrolanddescribesitsadvantages.ItisconcludedthattorealisetheobjectivesofHA,aflexibleandsimpleapproachisneededinitspracticalapplicationacrossfoodbusinesses.Anyargumentthatthesystemcannotbeappliedwithoutfullydevelopedandwellstructuredfoodsystemswillultimayreduceitspotentialusefulnessinfoodsafetycontrol. Food-bornediseasesareanimportantpublichealthprobleminbothdevelopedanddevelocountries(WorldHealthOrganization(WHO),1984).Althoughtheirhealthandeconomicimpactsareneverfullyappreciatedbecauseofinsufficiencyofdata,availableinformationonincidence(WHO/InternationalCommissionofMicrobiologicalSpecificationforFoods(ICMSF),1980;Todd,1978)andassociatedhealthandeconomiccosts(egRobertsetal,1989;Roberts,1988;Todd,1985)indicatesthattheyconstituteamajorcauseofmorbidityandadrainonhumanandmaterialresources.AjointWHO/FAOexpertcommitteeonfoodsafetyobservedthatillnessduetocontaminatedfoodisprobablythemostwidespreadhealthprobleminthecontemporaryworld,andanimportantcauseofreducedeconomicproductivity(WHO,1984).Foodcontaminationisalsoamajorriskfactorininfantdiarrhoeaandassociatedmalnutrition.Itisestimatedthatindevelocountriesinparticular,about70%ofallcasesofinfantdiarrhoeaiscausedbycontaminatedfood(Mortajemietal,1993).Thereiswideacceptancethattraditionalapproachesbasedmainlyoninspectionsandend-producttestinghavefailedtomeetthechallengesoffood-bornediseasesandillnesses.Theinadequaciesofinspectionforinstancehavebeenhighlightedinanumberofreports.First,theyrelyonquickobservationofproductsandpractices,andthisislikelytogivelittleinformationonthebasisofwhichmeaningfulconclusionscanbereached(EhiriandMorris,1994).Mostofthepoorpracticeswhichoftenleadtooutbreaksoffood-bornediseases,egimpropercoolingandunacceptabledelaybetweenfoodpreparationandserviceareusuallyinevidenceovernightandatothertimeswheninspectionmaybeimpracticable(Bryan,1988).Again,althoughthechangingepidemiologyoffood-bornediseaseshasbeenreportedinanumberofstudies(eg,ArcherandYoung,1988;Cox,1989;Critchleyetal,1989;Rodriguezetal,1990;Wilkinsonetal,1991;Trickett,1992),traditionalinspectionprocedureshavefailedtorecognizethesechanges.Forexample,areportbythecommitteeonthescientificbasisofthemeatandpoultryinspectionprogrammeintheUSA(NationalResearchCouncil,1985)suggeststhattraditionalinspectionprocedureshavenotchangedfornearly70years,andthatmeatinspectorsrelymostlyonsight,smellandtouchtoarriveatdecisionsonthesafetyofanimalsandcarcasses.SimilarexperiencehasbeenreportedinNewZealand(HathawayandMcKenzie,1991),whileTebbutt(1986)hasnotedthepoorcorrelationbetweenmicrobiologicalreportsandvisualinspection.Expressingtheirdoubtsabouttheeffectofinspectionsonfoodsafety,KaplanandElAhraf(1979)arguethatthereisnoscientificrationaleforthetraditionalbeliefthatfoodestablishmentsshouldundergoanarbitraryregimenofinspectionsannually.Forexample,astudy(Kirshner,1990)ontheeffectsofthefrequencyofinspectioninfoodserviceestablishmentsoncompliancewithfoodsafetyregulationsandtheoccurrenceoffoodbornediseaseoutbreaksinOntario,Canada,showedthattherewasnodifferenceininfractionscores,andtheoccurrenceoffood-bornediseaseoutbreaksinestablishmentsassignedastandardofsixinspectionsperyear,comparedtothoseassignedaregimenoftwoorfourinspections.End-producttestingontheotherhand,isnotonlytimeconsuming,alsoreactive.Anegativeresultonlycallsforremedialactionbyoperatorsorbylocalauthorities(usuallypunitive)butdoesnotpreventtheoccurrenceofthehazardinthefirstplace.Inmostcasesasamplingfrequencythatisadequateforreliabledetectionoflowlevelsofpathogensisseldompossiblebecauseofthelargernumberofsamplesneeded(NationalAdvisoryCommitteeonMicrobiologicalCriteriaforFoods(NACMCF)1992).Giventheever-increasingincidenceoffood-bornediseasesandthe ingsoftheseapproaches,thereisanurgentneedtoapplyalternativeapproachesofproveneffectiveness.OnesuchapproachistheHazardy.ri.r,CriticalControlPoints(HA)systemwhichhasbeendescribedasthemostviablemeanstothepreventionoffoodbornediseasesyetdevised(MichanieandBryan,TheHAconceptisnotnewasmanywronglyproject.Thenotionofcriticalcontrolpoint();ie,apoint,steporprocedureatwhichcontrolcanbeappliedandafoodhazardcanbeprevented,eliminated,orreducedtoacceptablelevels(NACMCF,1992),wasfirstpostulatedattheUSNationalConferenceonFoodProtection(1971),whereBauman(1971a,b)presentedproceduresfordefiningandidentifyingthem.DevelopmentandapplicationoftheseideaswerechampionedbytheNationalAeronauticandSpaceAdministration(NASA),theNatyckLaboratoriesandthePillsburyCompany.By1974,HA hadbeenappliedtothemanufactureoflowacidcannedfoodsbytheUSFoodandDrugAdministration(FDA).Theapplicationof tofoodsafetycontrolisbasedonthepremisethatpotentialfoodhazardsandfaultypracticescanbeidentifiedduringoperations,oftenintimetopreventorminimiseriskstotheconsumer,oreconomicburdenontheoperatorasaresultofspoilageorrecallofmarketeditems(Bryan,1981a).PreventingproblemsfromoccurringistheparamountgoalunderlyinganyHAsyste(NACMCF,1992).AschematicpresentationoftheactivitiesinvolvedintheestablishmentofaHAsystemispresentedonFigure1,whileFigure2givesdetailsofthestepsthatmaybefollowedinthedeterminationof s.Detailedexplanationofthesestepscanbefoundelsewhere(eg,NACMCF,1992;Bryan,1992;BerendsandSnijders,1994).EpidemiologicalbasisfortheapplicationofHAtofoodsafetyDatafromdiseasesurveillanceandresearchprovidecluestotheepidemiologicalcycleoffood-bornediseasesinindividuals.Forinstance,foranindividualtoacquireafood-bornedisease,thecausativeagentmustbepresentinindividualsinthecommunity,infoodanimalsorintheenvironmentinwhichfoodsaregrown,harvested,processedorstored(Bryan,1981a).Thereservoirsforthecausativeagentsusuallyincludepatients,healthyindividuals(egfoodhandlers),foodanimalsortheenvironment(egsoil).Inaddition,chemicalswhichcontaminatefoodsaremostlythoseusedeitheraspesticides,manureorforculinarypurposes.Anagentmaycontaminateafoodplantduringcultivation,harvestorduringprocessing,preparation,storageorservice.Fruitsandvegetablescanbecontaminatedfromsoilduringcultivationorharvesting;animalscanbeinfectedcongenitally,orduringrearing.Eggsforexample,canbecontaminatedduringformation,contactwithnestsorfromdrops(Bryan,1981a).Practicesandprocedureswhichoftenleadtotheoccurrenceofoutbreaksoffoodbornediseaseshavealsobeenstudiedacrossanumberofcountries.IntheUSAtheyinclude,inorderofimportance(measuredintermsoffrequencyofoccurrence):impropercoolingoffoods,unduedelaybetweenfoodpreparationandservice,contaminationbyinfectedfoodhandlers,inadequatetime-temperatureexposureduringheatprocessingoffoods,hotstorageandreheating(Bryan,1988).InAustralia,thesinglemostimportantfactorisinadequatetime-temperaturecontrolinthestorageoffoods(Davey,1985).InEnglandandWales,thecontributingfactorsinclude,inorderofimportance,unduedelaysbetweenfoodpreparationandservice,inadequatetemperatureexposureduringhotstorageoffoods,impropercooling,inadequatetimetemperatureexposureduringheatprocessingoffoods,contaminationbyfoodhandlersandingestionofrawfoods(Roberts,1982).TheHA systemisuniqueinitsapproachtofoodsafetycontrolinthesensethatitutilisesthisinformationaswellasdataonmicrobialecologyoffoods,inactivelypreventingproblemsfromoccurring.TheimportanceofHAinfoodsafetyPerhapsthemostimportantadvantageoftheHAsystemistheincreasedsafetyconsciousnessthatitislikelytopromoteamongfoodbusinessoperatorsbyincorporatingfoodsafetyintoeverystageoffoodoperation.Itachievesthisbyrequiringoperatorstoidentifyanystepintheiractivitieswhichiscriticaltoachievingfoodsafety,andtoensurethatadequateandeffectivesafetymeasuresareidentified,implemented,maintained,monitoredandevaluated.Itencouragesanoperatorto yseprocessesfromasystemsviewpoint,sothatstaffcanidentifyandcorrecttroublespots,andverifytheadequacyofinternalquality-controlsystems,ordeveloponeifnoneexists(Hile,1974).TheWHOandtheICMSF(1980)havestronglyadvocateditsapplicationthroughoutthefoodchainasthewayforwardinpreventingandcontrollingfood-bornediseases.TheECDirectiveonHygieneofFoodstuffs(EC,1993)also mendsitsactiveimplementationinallfoodbusinesseswithinthecommunity.IntheUSA,theFoodCodereleasedbytheFDAin1993nowrequiresregulatoryprofessionalstoimplementtheirfoodprogrammesbasedontheprinciplesofHA .TheHA systemisdesignedtoidentifypotentialproblemsassociatedwithaproductratherprecisely,anditprovidesacleardefinitionofwhatneedstobedonetocorrectobjectionableconditionsandprocedures.Mostimportantly,itprovidesaninsightintothewayinwhichanoperationisfunctioning365daysayear,especiallywhenaninspectorisnotthere(Hile,1974).TheideaofHAalsoseemstobeofimmensepracticalvalueundertheUKFoodSafetyAct,1990whichhasprovisionfordefenceofduediligence(FoodSafetyAct,1990).ItisarguedthatanoperationalHAsystemcanconstitutesufficientdemonstrationthatduediligencehasbeentakentopreventtheoccurrenceofparticularhazards(EhiriandMorris,1994).HA isequallyvalidindevelocountrieswhereitcanbeusedtominimisethehealthandeconomiccostsoffood-bornediseasesandfoodspoilage.Itcanalsohelptopromoteforeignearningsfromfoodtradebyenhancinginternationalacceptabilityofproducts.HAimplementation:TheneedforaflexibleTheHAconcepthasitsrootinthefoodprocessingindustrywhereroutineoperationsfollowwelldefined,uniformpatterns.Therefore,anyattempttoapplyitinothersectorsofthefoodbusinesswherethisrequirementislackingmustadoptaflexibleapproachifnegativeimpactsandunduedifficultiesaretobeavoided.TakenrigidlyaspresentedinFigure1forinstance,onemightbepersuadedtoarguethatthesystemcanbebestappliedtoestablishmentswiththetypeofcentralizedproductionthatpermitdefinedoperationalpatterns.Itmayalsobearguedthatthesystemwillworkbestinestablishmentswithwellstructuredorganisationalandmanagementcontrolsystems.Forthisreason,therehasbeenafeelingthatHAisnotwellsuitedforthefoodserviceindustrywhereuniformstandardproceduresareseldomfollowed.Thereisoftenawidescopeforvariationandimprovisationsinfoodserviceoperations,dependingonprevailingcircumstancesandtheskillsofemployeesondutyataparticulartime.AccordingtoSheared(1986)interestisusuallyfocusedonmeetingatalltimes,thedemandforfoodbycustomers,andnotonproceduresforpreparation,whichusuallyrestsonthediscretionofemployees.Ironically,theneedfortheapplicationofHA ismoreurgentinfoodservicebusinesseswhich,fromavailableevidenceareoftenresponsibleformostoutbreaksoffood-bornediseases(eg,Bryan,1978;1979;1981a;1988).AlthoughanumberofstudieshavedemonstratedtheapplicabilityofHAinfoodserviceoperations(eg,BobengandDavid,1977;Bryan,19816;1990),thereisagrowingconcernthatthesystemdoesnotreadilycommenditselftowiderapplicationinnormalcateringoperations.Thisunderscorestheneedforflexibilityinitsapplicationacrosstypesoffoodbusinesses,especiallyinthosesectorswhereitsneedismostapparent.ThemainobjectivesoftheHAsystemaretoidentifyhazardsinafoodoperation,todetermineprocedurescriticaltofoodsafety,andtodeviseandimplementeffectivepreventivemeasurestoensurecompliancewithapprovedcriticallimits,iecriteriawhichmustbemetforeachpreventivemeasureassociatedwitha (NACMCF,1992).AsMarcello(1994)argues,’HAisaprocesstobeinitiatedandnotaprogrammetobeimplemented,...itisasmuchathoughtprocessasitisafoodsafetymanagementsystem.Butattemptsto.standardizethesystemhasresultedindefiningitintermsofflowdiagramsandrecord-keeratherthanencouragingbehaviorsthatcontrolfactorswhichcontributetofood-bornediseases’.ThereisanunfortunatetendencytoregardHAasaprogrammetobecontractedout,orasaone-offpaperexercise;andtheremayevenbeatemptationforfoodoperatorstoengagetheservicesofoutside’consultants’todevelopforthem,’paper-basedHAsystems’,withoutthemselvesunderstandingtheconceptandlackingprocedurestofacilitateitspracticalapplication.Thisisadevelopmentthathastobeguardedagainst,iftheobjectivesofHA aretoberealized. y,everyoperation,beitinthefoodprocessingindustryorinfoodserviceestablishments,consistsofaseriesofclearlyidentifiabletasks.Aseachtaskis plished,itisincorporatedintotheoveralloperatingproceduresthatmakeupthebuildingblocksinthedevelopmentofamanagementsystem(Marcello,1994).Basedonourunderstandingofpracticesandproceduresthatoftenleadtooutbreaksoffood-bornediseases,wecanidentifyforeachoperation,thosetaskswhicharecriticaltofoodsafetycontrol.Ifforagivenoperation,poortime-temperaturecontrol,unacceptablehygienestandardsamongstaff,faultyequipmentorcrosscontaminationareidentifiedasthesignificantproblemareas,controlofthesefactorsintheprocessing,preparationorserviceoffoodsshouldformbasisfortheestablishmentofprioritiesforaHA schemeinthatestablishment.TheforegoingdiscussionhasprovidedanoverviewofthebasisfortheapplicationofHAinfoodbusinesses,aswellassomeoftheunanticipateddifficultiesthatmayariseinitsimplementationacrossfoodbusinesses,especiallyinthefoodservicesector.Inaddition,ithastoberealizedthatfoodsafetyproblemswillnotdisappearwiththeimplementationofHA.Easteretal(1994)havearguedthatonitsown,thesystemismainlyusefulasatechniqueforyzinghazardsandidentifyingthecriticalcontrolpointsinaprocess.Managingtheseonadailybasistheyargue,willrequiremanyothersupportingprocedures.Thescience-basednatureofHAshouldnotbeallowedtoovershadowtheneedtoemphasizeitssimplepracticalobjectives.Thesystemshouldnotbeseenasaprogrammetobeimplemented,butasaprocesstobefollowedonapracticalanddailybasis.Itshouldalsobeseenasabasisforestablishingprioritysafetyareas,andforimprovingalreadyexistingsafetymechanismsinfoodestablishments.Anyunderstandingthattheprinciplesof cannotbeappliedwithoutafullydevelopedsystem,flowcharts,andextensivepaperworkwillinevitablypresentamajorblocktoitswideracceptanceandimplementation,especiallyinthosesectorswhereitismostneeded.HAimplementationshouldbebasedonflexible,simple,practicalandcost-effectiveapproaches.In ngsohowever,theobjectivesofthesystemshouldneverbecompromised.HA在食品企業(yè)中的實施：需要一個靈活的方作者：1.JohnE 2.GeorgeP國籍：1.新西蘭2.出處：1995年8月，英國學會健康雜志，第249至253同樣在食物鏈階段很多表明因為食品和做法或最小化對健康的風險但是食源性疾病仍然嚴重公眾健康因為最終產(chǎn)理和有效的。其中之一的方法就是危害分析，關(guān)鍵控制點（HA）系統(tǒng)，這是目前國際在討論的本文探討了HA的流行病學基礎(chǔ)在食品安全控制中的應用并介紹了它的優(yōu)勢結(jié)論為了實現(xiàn)HA的目標需要在整個食品企業(yè)的糧食系統(tǒng)，這種說法最終將降低其在食品安全控制的潛在用途。1.引不能完全理解，但是對（WHO微生物規(guī)范食品（ICMSF），1980/國際委食品安全的WHO/FAO專家，由于患病污染的食物可能是世界上食品污染也是嬰兒腹瀉及營養(yǎng)不良的主要據(jù)估計特別是發(fā)展中國家，70％嬰兒腹瀉的病例是由于污染的食品（Mortajemi，1993）。年;等人，1990年;威爾金森等人，1991;特里克特，1992），傳統(tǒng)的檢驗程序都沒有認識到這些變化。例如，在（國家研究，1985）類和家禽檢驗方案報告的科學基礎(chǔ)上，認為，傳統(tǒng)的檢測方法近70年沒安全范圍。新西蘭已經(jīng)類似的經(jīng)驗（哈撒韋和McKenzie的，1991），而特ElAhraf（1979）認為，傳統(tǒng)觀念品安全的餐飲服務(wù)場所檢查頻率和食源性疾病暴發(fā)的發(fā)生場所的研究表明：每年六個檢驗標準，相比那些指定的兩個或四個檢查的方案，結(jié)果顯示行為。另一方面，成品檢驗不僅費時費力，而且定性的結(jié)果只要求運營商或方法。預防食源性疾病的最可行的法是Hazardy.ri.r，關(guān)鍵控制。（HA）體系（Michanie和Bryan，1987）HA的概念有錯誤的理解并不新鮮。關(guān)鍵控制點的概念（）即，一個的Natyck和Pillsbury公司倡導。到1974年，HA 頭食品由食品和藥物管理局（FDA）的制造。食品安全控制應用程序HA是基于潛在食物危害和不完善的實踐可以在操作期間被識別從而經(jīng)常防止或盡量減少腐壞或被給消費者，或者操作者的經(jīng)濟負擔風險（布萊恩，1981a）基本任何HA系統(tǒng)的最重要的目標都是為了防止發(fā)生問（NACMCF，（例如，NACMCF，1992;布萊恩，1992;BERENDSSnijders，1994）HA在食品安全控制中的應用流行病學基中或以食物成長環(huán)境，收獲，加工和（布萊恩，1981a）的。儲層的病原體外，化學物質(zhì)污染的食品，主要是那些用來作為，肥料或用于烹飪的目的。在，按重要性的順序（在發(fā)生頻率測量）：食品的冷卻不當，準備食物和服務(wù)之間的延誤受的食物處理污染食品熱加工過程中的溫度時間不夠，熱和加熱（布萊恩，1988）。在澳大利亞，一個最重要的因素是食品保存溫性順序準備食物和服務(wù)之間過度的延遲過食品溫度不夠散熱不良，食品熱加工過程中的溫度，由和食品原料污染（羅伯茨，1982）。HA體系利用這些信息以及對食品微生物生態(tài)學數(shù)據(jù)，積極預防問題HA在食品安全保障的重要也許HA體系的最重要的優(yōu)勢是增加了安全意識它很可能通過將食品安一個（HILE，1974年）。世界衛(wèi)生組織和ICMSF（1980）曾強烈在預防和控制食建議，積極在社區(qū)內(nèi)的所有食品企業(yè)實施。在，1993年食品FDA要求現(xiàn)在人員根據(jù)HA 最重要的是，它提供了運作一年365天的操作方式，特別是不存在檢查員時 根據(jù)1990年國防盡職的規(guī)定（食品安全法，1990）。有人認為，運行HA體系可以構(gòu)成充分的論證，為防止危害發(fā)生已采取盡職（ehiri和Morris，1994）。HA是同樣在發(fā)展中國家有效的，它可以用來減少健康和經(jīng)濟成本的食源性疾病和食品。它也可以幫助促進來自食品貿(mào)易的外匯收入，通過提高HA的實施：一個靈活的方法的需HA的概念于行業(yè)，遵循良好的，統(tǒng)一的模式常規(guī)操作。因此，任何試圖把它應用于在其他行業(yè)的食品業(yè)務(wù)，如果要避免影響和不必要的，必須是采用靈活的方法。例如圖1采取嚴格的措施，人們可能被說服認因，HA是不適合用于很少有人問津的食品服務(wù)行業(yè)統(tǒng)一標準程序。往往有而不是過程，這個過程通常依賴于員工自覺符合步驟制作。具有諷刺意味的是，從現(xiàn)有的證表明HA需要應用于更為迫切的食品服務(wù)企業(yè)，因為那里往往是食源性疾病的爆發(fā)的（布萊恩，1978；1979；1981a；1988）。雖然一些研究已經(jīng)證實HA在食品服務(wù)業(yè)務(wù)的適用性（例如，博泵和戴維，1977；布萊個預防措施與（NACMCF，1992）。馬塞洛（1994）認為，“HA是一個過食源性疾病的激勵行為“這是將HA承包出去的計劃，是一個不幸的傾向，HA系統(tǒng)，沒有自己的理解的概念和缺乏程序便于HA的目標得以實現(xiàn)，必須警惕。幸運的是，每一個操作，無論它是在業(yè)還是食品服務(wù)場所，由一系故障或交叉污染被確定為重要的問題，這些因素在，準備或服務(wù)控制應成為建立HA計劃的優(yōu)先事項。結(jié)前面的討論提供了HA應用于食品企業(yè)的概述以及一些在食品企業(yè)實施可能出現(xiàn)的意想不到的，特別是在食品服務(wù)業(yè)。此外，必須實施HA，食品安全問題不會。Easter等人（1994）認為，就其本身而言，該基于科學的HA自然不應被其簡單實用的需求所掩蓋該系統(tǒng)不應被視為統(tǒng)流程圖和大量的文書工作不能應用HA原理將不可避免地對它的廣泛接受和實施是一個重大的阻礙尤其是在這些部門最需要它的地方HA的實到影響。外文翻譯之OneHA ,TwoApproaches:ExperiencesWithandPerceptionsoftheHazard ysisandCriticalControlPointFoodSafetyManagementSystemsintheUnitedStatesandtheEU作者：1.RichardHyde2.A.BryceHoflund3.Mice國籍：1.USA2.USA出處：August2014,Administration&Society,SummaryThisarticleexploresthedifferencesintheuseoftheHazardysisandCriticalControlPoint(HA)systemtomanagefoodrisksinthefoodchainfromfarmtoforkintheEUandtheUnitedStates.Inparticular,thisarticleinvestigatesthecurrentusesandpotentialexpansionof asamechanismforthedeliveryofsafeagriculturalproducts,particularlysafeproduce.Usingdataderivedfromsemi-structuredinterviewswithregulatoryactorsintheEUandtheUnitedStates,thisarticlearguesthatthedifferentapproachtoHA isaresultofdifferingideasabouttherolethatitplaysintheernanceoffoodsafetyandthedifferentconceptsoftheroleofregulationinsecuringsafefood.Finally,thearticleexploresdifficultiesofutilizingHAtomanageproducesafetyrisksandraisesfurtherchallengesthatmustbemettoensurethatHAcansuccessfullyfulfillitspotentialasaernancemechanism：HazardysisandCriticalControlPointsystem,foodregulation,EuropeanUnion,UnitedStates,democraticexperimentalism,foodsafetymanagementsystemsInrecentyears,boththeEuropeanUnionandtheUnitedStateshaveexperiencedanumberofwell-publicizedfoodsafetyincidentsthathavecalledintoquestionthecapacityoftheexistingregulatoryapparatustoensuresafefoodforconsumers.IntheUnitedStates,therehavebeenrecallsofspinach,peanuts(andpeanutproducts),lettuce,groundbeef,andotherproducts.AndinthelastfewyearsintheEU,Spanisheggs,Italianclams,FrenchandIrishoysters,Polishsausages,andmincedbeeffromSwedenhaveallbeenrecalled,alongwithotherproducts.Overthelastdecade,intheaftermathofbovinespongiformencephalopathy(BSE)or“madcow”disease,theEUhascreatedanewintegratedregimeregulatingfoodsafety,buttheUnitedStatesisstillgrapplingwiththeseincidentsanddebatingwhichregulatoryroadtopursue(Haines,2009).CentraltotheEUregimeistherequirementthatafoodsafetymanagementsystembasedonHazard ysisandCriticalControlPoints(HA)beimplementedatmoststagesoffarm-to-forkfoodproduction,anditisstronglyencouragedinallotherareas,includingprimaryproduction.Todate,intheUnitedStates,therehasnotbeenaformalrequirementtoimplementafoodsafetymanagementsystemakintotheEUmandate,butsuchsystemsareencouraged,particularlybytradeassociations.Here,weareinterestedinthesimilaritiesanddifferencesinexperiencesofboththeEUandtheUnitedStatesintheirapproachestofoodsafetyand,inparticular,theirjourneyssurroundingfoodmanagementsystems.Eliteinterviewswithfoodsafetyprofessionalsin ernment,industry,andinterestgroupsinboththeUnitedStatesandtheEUdemonstratetwocurrentapproachestowardincreasedfoodsafetyanduseofHA.IntheUnitedStates,wehaveuncoveredagrowinginterestandmovementtowardtheadoptionofflexibleandcustomizablemechanisms,suchasHA,toensurefoodsafety.WherethesesystemshavebeenimplementedintheUnitedStates,thedrivershavegenerallybeenfromindustryitself.Thisbusiness-drivenuseofHAcontrastswiththecurrentpositionintheEU,whereapolicydecisionwasmadetocreateacentralizedregulatoryregimewithHAasoneofitscenterpieces.PriortotheformaladoptionofRegulation178/2002,whichrequiresHAwithintheEU,therewasmovementtoadoptHAinthefood-manufacturingsector,ledbythesupermarketsthroughragreements(Havinga,2006).ThismaysuggestthattheUnitedStatesisfollowingasimilarevolutionarypathtotheEU,movingfrombusiness-driventoregulator-drivenadoptionofHA.WearguethatthedifferentapproachestoHA arearesultofdifferingideasabouttherolethatHA playsintheernanceoffoodsafetyandthedifferentconceptsoftheroleofbusinessandofregulationinensuringsafefood.WeillustratethecontrastingpolicychoicesandattemptilluminatethedriversbehindthedifferentpolicydecisionsintheUnitedStatesandtheEU.Weconsiderhowthetwoapproachescreatelinkagesbetweenactorsinthefoodproductionsphere,howthedifferentapproachesinfluencetheactionsofdecisionmakers,andweilluminatethesimilaritiesanddifferencesofapproach.Finally,weexplorethestrengthsandweaknessesofthecontrastingapproachesandconsiderhowtheymaybeappliedtotheprimaryproductionofproduceintheUnitedStatesandtheEU.Thesection intheContextofSelf-RegulatoryApproaches”examinesHAanditsuseasaregulatorytechnologywithintheUnitedStatesandtheEU,beforeconsideringhowregulatorsareusingHA ,particularlyintheproducesafetycontext.ItalsoplacesHA withintheregulatoryliteratureandconsidersitsroleasaregulatoryintervention.“Method”sectionprovidesabriefoverviewofthemethodology.“Findings”sectionexaminesdatagatheredfrominterviewswithregulatoryactorsintheUnitedStatesandEUtoconsider,first,therolethatHAcanplayinensuringsafeproduceand,second,whatis,andcanbe,theroleplayedbyHAwithintheEUandtheUnitedInthissection,wediscussourinterviewfindingsandprovideanoverviewofHAatworkintheEUandtheUnitedStates.WediscussandcomparetheimplementationofHAintheEUandtheUnitedStatesbyfivekeythemesdrawnfromourempiricalwork:businesssize,businesstype,routinization,enforcements,andperceptionsofHA.Insomecases,similaritieswerediscerned,whereasinothersinterviewdataidentifiedComparingHA RegulationintheEUandtheUnitedStates:HAandBusinessSizeTheEUintervieweesexpressedtheviewthatHAworkedbetterforlargerbusinessesbecausesuchbusinesseshavegreaterresourcesandlargerprocesses,bothofwhichareconducivetothemoreefficientimplementationof edfoodsafetymanagementsystem.TheU.S.intervieweessupportedthisconclusion.However,themorelimitedrequirementstoimplementHAintheUnitedStatesmeantthatsmallerfoodbusinessescouldchoosetoproduceedproceduresmoretailoredtotheirneeds,whereasintervieweesdrawnfromEuropeanbusinesses,whichhavenochoiceoveradoptingHAasameansofmanagingfoodsafetyrisks,oftenfeltthattheyarebeingaskedtocompleteunnecessarypaperwork.ThesuggestionofGunningham(2002)thatsmall-andmedium-sizedenterprisesresponddifferentlytoprocess-basedregulationwhencomparedwithlargeenterprisesissupportedbythisresearch.Intervieweeshighlightthemorelimitedresources(oftime,money,and nel)andexpertiseofsmallfoodbusinessesasinhibitingthedesireandabilityoffoodbusinessestoimplementItseemsclearthatourintervieweesperceivelargebusinessesasbenefitingfromHAmorethansmallbusinesses.ThisisborneoutbytheU.S.experiencewherelargebusinesseshavechosentouseHA,andsmallbusinesseshave,byandlarge,chosennotto.ThebusinessbenefitsofHA,suchasgreaterbusinessesefficiency,aremoreimportanttolargebusiness,whichhavemorediverseoperations,thantosmallbusinesses, al,ratherthanprocessdriven,oversightismorelikelytobeComparingHA RegulationintheEUandtheUnitedStates:HAandBusinessTypeInadditiontoadividebetweenlargeandsmallbusiness,intheEU,HA perceiveddifferentlybyfoodprocessorsandmanufacturersandbyretailerswhosupplythefoodtothefinalconsumer.Whilethismaybepartiallyanartifactofsize,italsoreflectstheperceivedusefulnessofHA tothesedifferentsituations.HA ,initiallycreatedforlarge-scalefoodprocessingwherethemonitoringofcriticalcontrolpointscanbeintegratedintotheworkflowswithinthebusiness,isseenasbettersuitedtolarge-scaleprocessing.Withsmall-scalecatering,wherelargenumbersofdifferentdishesmaybecreatedasmallnumberoftimeseachday,integratingHAintothebusinessesisseenasmoredifficult.OneEUinterviewee,aconsultantfoodhygienist,wentsofarastosaythatitwasimpossibletoimplementHAproperlyinacateringbusiness.Althoughsomegeneralcontrolpointscanbeimplementedandmonitored(e.g.,temperaturefollowingcooking),businessesfeltthattheyarebeingaskedtotailorplanstoeachproduct,whichisnotne