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外文翻译之 implementationinfoodbusinesses:theneedforaflexibleapproach作者:1.JohnE 2.GeorgeP国籍:1. 2.出处: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在食品企业中的实施:需要一个灵活的方作者:1.JohnE 2.GeorgeP国籍:1.新西兰2.出处:1995年8月,英国学会健康杂志,第249至253同样在食物链阶段很多表明因为食品和做法或最小化对健康的风险但是食源性疾病仍然严重公众健康因为最终产理和有效的。其中之一的方法就是危害分析,关键控制点(HA)系统,这是目前国际在讨论的本文探讨了HA的流行病学基础在食品安全控制中的应用并介绍了它的优势结论为了实现HA的目标需要在整个食品企业的粮食系统,这种说法最终将降低其在食品安全控制的潜在用途。1.引不能完全理解,但是对(WHO微生物规范食品(ICMSF),1980/国际委食品安全的WHO/FAO专家,由于患病污染的食物可能是世界上食品污染也是婴儿腹泻及营养不良的主要据估计特别是发展中国家,70%婴儿腹泻的病例是由于污染的食品(Mortajemi,1993)。年;等人,1990年;威尔金森等人,1991;特里克特,1992),传统的检验程序都没有认识到这些变化。例如,在(国家研究,1985)类和家禽检验方案报告的科学基础上,认为,传统的检测方法近70年没安全范围。新西兰已经类似的经验(哈撒韦和McKenzie的,1991),而特ElAhraf(1979)认为,传统观念品安全的餐饮服务场所检查频率和食源性疾病暴发的发生场所的研究表明:每年六个检验标准,相比那些指定的两个或四个检查的方案,结果显示行为。另一方面,成品检验不仅费时费力,而且定性的结果只要求运营商或方法。预防食源性疾病的最可行的法是Hazardy.ri.r,关键控制。(HA)体系(Michanie和Bryan,1987)HA的概念有错误的理解并不新鲜。关键控制点的概念()即,一个的Natyck和Pillsbury公司倡导。到1974年,HA 头食品由食品和药物管理局(FDA)的制造。食品安全控制应用程序HA是基于潜在食物危害和不完善的实践可以在操作期间被识别从而经常防止或尽量减少腐坏或被给消费者,或者操作者的经济负担风险(布莱恩,1981a)基本任何HA系统的最重要的目标都是为了防止发生问(NACMCF,(例如,NACMCF,1992;布莱恩,1992;BERENDSSnijders,1994)HA在食品安全控制中的应用流行病学基中或以食物成长环境,收获,加工和(布莱恩,1981a)的。储层的病原体外,化学物质污染的食品,主要是那些用来作为,肥料或用于烹饪的目的。在,按重要性的顺序(在发生频率测量):食品的冷却不当,准备食物和服务之间的延误受的食物处理污染食品热加工过程中的温度时间不够,热和加热(布莱恩,1988)。在澳大利亚,一个最重要的因素是食品保存温性顺序准备食物和服务之间过度的延迟过食品温度不够散热不良,食品热加工过程中的温度,由和食品原料污染(罗伯茨,1982)。HA体系利用这些信息以及对食品微生物生态学数据,积极预防问题HA在食品安全保障的重要也许HA体系的最重要的优势是增加了安全意识它很可能通过将食品安一个(HILE,1974年)。世界卫生组织和ICMSF(1980)曾强烈在预防和控制食建议,积极在社区内的所有食品企业实施。在,1993年食品FDA要求现在人员根据HA 最重要的是,它提供了运作一年365天的操作方式,特别是不存在检查员时 根据1990年国防尽职的规定(食品安全法,1990)。有人认为,运行HA体系可以构成充分的论证,为防止危害发生已采取尽职(ehiri和Morris,1994)。HA是同样在发展中国家有效的,它可以用来减少健康和经济成本的食源性疾病和食品。它也可以帮助促进来自食品贸易的外汇收入,通过提高HA的实施:一个灵活的方法的需HA的概念于行业,遵循良好的,统一的模式常规操作。因此,任何试图把它应用于在其他行业的食品业务,如果要避免影响和不必要的,必须是采用灵活的方法。例如图1采取严格的措施,人们可能被说服认因,HA是不适合用于很少有人问津的食品服务行业统一标准程序。往往有而不是过程,这个过程通常依赖于员工自觉符合步骤制作。具有讽刺意味的是,从现有的证表明HA需要应用于更为迫切的食品服务企业,因为那里往往是食源性疾病的爆发的(布莱恩,1978;1979;1981a;1988)。虽然一些研究已经证实HA在食品服务业务的适用性(例如,博泵和戴维,1977;布莱个预防措施与(NACMCF,1992)。马塞洛(1994)认为,“HA是一个过食源性疾病的激励行为“这是将HA承包出去的计划,是一个不幸的倾向,HA系统,没有自己的理解的概念和缺乏程序便于HA的目标得以实现,必须警惕。幸运的是,每一个操作,无论它是在业还是食品服务场所,由一系故障或交叉污染被确定为重要的问题,这些因素在,准备或服务控制应成为建立HA计划的优先事项。结前面的讨论提供了HA应用于食品企业的概述以及一些在食品企业实施可能出现的意想不到的,特别是在食品服务业。此外,必须实施HA,食品安全问题不会。Easter等人(1994)认为,就其本身而言,该基于科学的HA自然不应被其简单实用的需求所掩盖该系统不应被视为统流程图和大量的文书工作不能应用HA原理将不可避免地对它的广泛接受和实施是一个重大的阻碍尤其是在这些部门最需要它的地方HA的实到影响。外文翻译之OneHA ,TwoApproaches:ExperiencesWithandPerceptionsoftheHazard ysisandCriticalControlPointFoodSafetyManagementSystemsintheUnitedStatesandtheEU作者:1.RichardHyde2.A.BryceHoflund3.Mice国籍:1.USA2.USA出处: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
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