食品安全目标的建立及应用.ppt

食品安全目标的建立及应用FoodSafetyObjective,杨明亮湖北省卫生厅卫生监督局,ManagingtheFoodSafetyCliff,HAZARD/RISK,FSO,CliffHAZARDPROCESSVARIABILITY,FOODBORNEILLNESS/DEATH,FromMartinCole,2002年,国际食品微生物标准委员会(TheInternationalCommissiononMicrobiologicalSpecificationsforFoods,ICMSF)在所出版的MicroorganismsinFood7volume中介绍了一个新的食品安全管理概念：食品安全目标（FoodsafetyObjective，FSO)。2004年,国际食品卫生法典委员会(CodexCommitteeonFoodHygiene,CCFH)第36次会议接受并建立了“食品安全目标”的定义。“食品安全目标”的概念提出后，得到国际社会的重视，正在被广泛地接受及推广应用。,FSO：AFOODSAFETYCONTROLCONCEPT,一、FSO的背景,随着全球食品贸易的发展，各国政府十分重视食品安全的管理与监督，一来加强进出口食品的管理，二来保护国民健康。根据WTO卫生和植物卫生措施协定（SPS）规定,允许WTO成员在可获得的科学依据的基础上,按有关情况对进口动植物风险进行评估,确定适当的保护水平（theAppropriateLevelofProtection(ALOP)，保护本国人民、动物或植物生命或健康。,一、FSO的背景,ALOP：WTO成员国通过保护本国人民、动物或植物生命或健康的卫生或植物措施以实现的被认为适当的保护水平。也就是可接受的风险水平(theacceptablelevelofrisk)。TheSPSAgreementdefinestheappropriatelevelofsanitaryorphytosanitaryprotectionasthelevelofprotectiondeemedappropriatebytheMemberestablishingasanitaryorphytosanitarymeasuretoprotecthuman,animalorplantlifeorhealthwithinitsterritory.Thisconceptisalsoreferredtoastheacceptablelevelofrisk.,一、FSO的背景,在食品安全方面，ALOP是通过食品安全体系拟实现的公共卫生保护程度。Inthecontextoffoodsafety,anALOPisastatementofthedegreeofpublichealthprotectionthatistobeachievedbythefoodsafetysystemsimplementedinacountry.,一、FSO的背景,具体讲，ALOP是一个国家有关一种特别危害与食品结合并消费时所造成的疾病负担。TypicallyanALOPwouldbearticulatedasastatementrelatedtothediseaseburdenassociatedwithaparticularhazard-foodcombinationanditsconsumptioninacountry.,一、FSO的背景,ALOP是一个公共卫生目标，通常表述为一个特定时间段人群中的病例数（每年1/100，000）。ALOPscanbeexpressedasapublichealthgoalintermsofnumbersofcasespergivennumberofpopulationoveraspecifictimeperiod,forexample,1in100,000perannum.,一、FSO的背景,例如美国HealthyPeople2010确定了ALOP：以2007年的数字为始点，到2010年Campylobacter,Listeriaonocytogenes,EscherichiacoliO157:H7的年发病率（每十万）减少50%。IntheUnitedStates,thedocumentHealthyPeople2010Usingthenumbersofillnessesin1997forinfectionsassociatedwithCampylobacter,Listeriamonocytogenes,EscherichiacoliO157:H7andSalmonellaspp.asastartingpoint,HealthyPeople2010seeksa50%reductioninthenumbersofcasesper100,000populationbytheyear2010。,ALOP,一、FSO的背景,基于上述的理解，ALOP是国家层面上的公共卫生目标，距离实际的食品安全管理甚远。ALOPisnotameasurethatismeaningfulforfoodsafetymanagementinpractice.为了解决这个问题，国际食品微生物标准委员会(ICMSF)提出了食品安全目标（FSO）的概念，作为ALOP与实际操作（performance）之间的桥梁（bridge)。(ICMSF)havebeenexploringtheconceptoffoodsafetyobjectivesasabridgebetweenanALOPandthevariousperformanceorprocesscriteriaroutinelyusedinproductionandmanufacture,一、FSO的背景,“桥”的意图是将ALOP转化成FSO，并具体到所关注的产品和危害上来。这样就能将公共卫生目标转化成对消费环节危害的数量描述（ICMSF）。TheintentionisthatanALOPwillbetranslatedintoanFSOthatspecifiestheproductandhazardcombinationconcerned.Inthisway,thepublichealthgoal(theALOP)canbetranslatedintoadescriptionoftheamountofhazardatthepointofconsumption。,二、FSO的概念,FSO：消费时/消费环节食品中微生物危害的最大频率和/或最高浓度，以提供适当健康保护水平（ICMSF）。Foodsafetyobjectivethemaximumfrequencyand/orconcentrationofamicrobiologicalhazardinafoodatthetimeofconsumptionthatprovidestheappropriatelevelofhealthprotection.（ICMSF，2002),二、FSO的概念,FSO：消费时/消费环节食品中所存在危害的最大频率和/或最高浓度，以提供适当健康保护水平（CAC）。Themaximumfrequencyand/orconcentrationofahazardinafoodatthetimeofconsumptionthatprovidesorcontributestotheappropriatelevelofprotection(CAC2004).最大频率:AfrequencyofSalmonellaenteritidisineggsnotexceeding1eggper100,000.最高浓度:Aconcentrationofsalmonellaeinpowderedmilkbelow1cfu/100g.,二、FSO的概念,便于理解和应用，ICMSF为FSO提出了一个概念性方程式（conceptualequation）：HoRIFSOHo：初始危害水平；R：总的危害下降值；I：总的危害上升值(growthorrecontamination)；FSO：食品安全目标。,二、FSO的概念,例如，当：（1）FSOforthepathogenproductcombinationis2（FSOlevel=100cfuL.monocytogenespergramLm/g）；(2）Ho0(level1cfu/g);(3)R=0;(4)I2，或I60022，或0062结论：符合FSO，或不符合FSO,三、FSO的工作原理,然而，FSO也只是在公共卫生目标（ALOP）与实际操作（performance)之间构造了一座“桥梁”，确定了“消费时食品中危害的最大频率和/或最高浓度”，它本身不能向食品生产经营者提供如何降低疾病水平的信息。FSOdoesnotprovidefoodprocessors,producers,handlers,retailersortradepartnerswithinformationaboutwhattheyneedtodotoreachthislowerlevelofillness.,三、FSO的工作原理,FSO必须结合食品安全管理的方法或措施的运用，才能实现公共卫生目标。,FromLeonGorris,三、FSO的工作原理,为此，还应了解新的概念：PerformanceObjectivePO)PerformanceCriterion(PC)ControlMeasures(CM)processcriterion,FromICMSF,三、FSO的工作原理,执行目标（PerformanceObjective):消费前食物链特定环节食品中所存在（微生物）危害的最大频率和/或最高浓度，以实现FSO或ALOP。例如SalmonellaeandpathogenicE.coli在包装果汁中不超过1cfu/10POsareequivalenttoFSO,specifyinghazardlevelsthataretolerable,butwhich1aresetatone2ormorespecificstepsearlierinthefoodchain(CAC,2004).PerformanceObjective(PO)：Themaximumfrequencyand/orconcentrationofa(microbial)hazardinafoodataspecifiedstepinthefoodchainbeforetimeofconsumptionthatstillprovidesorcontributestotheachievementofanFSOorALOP,asapplicable.ExamplePerformanceObjectivesSalmonellaeandpathogenicE.colishallnotexceed1cfu/10lwhenfruitjuiceispackagedfordistribution.,三、FSO的工作原理,执行标准（PerformanceCriterion）：一项或多项控制措施拟达到的效果，以满足执行目标和食品安全目标的要求。例如，确保低酸罐装食品中Clostridiumbotulinum减少12log;热加工汁液，使其中entericpathogens减少5log。PC=5DforE.coliO157:H7PerformanceCriterion(PC)：Theeffectofoneormorecontrolmeasure(s)neededtomeetorcontributetomeetingaPO/FSO或theoutcomeofaprocesssteporacombinationofsteps(changeinthelevelofamicroorganismormicrobialtoxin),三、FSO的工作原理,D，指D值，即在特定的温度下减少90%或1个对数值的微生物所需要的时间。TheD-valueisdefinedasthetimeataparticulartemperaturerequiredtoreduceaknownnumberofmicroorganismsby90%ortoresultina1-logreduction.,三、FSO的工作原理,MicrobialdeathisanexponentialprocessAgraphoflogNvs.timeisastraightlineThetimetakentoreducethenumberofviableorganismsbyonelogcycleiscalledtheDecimalreductiontime,DManyheattreatmentsachieveahazardlevelof1cfu/106g(6D).,ataparticulartemperature,？,Forexample,fromApp.A:(Beef)FTimeto6.5DTimeto7.0D13011212114012121506772,三、FSO的工作原理,三、FSO的工作原理,控制措施（ControlMeasures）：任何预防或消除食品安全危害或将食品安全危害降至可接受水平的行动或活动。例如，选择不含传染性致病菌的原料成分；产品的pH控制在4.6以下。thelevelofahazardinafinishedproductisnotonlydeterminedbythemagnitudeoftheeffectofacontrolmeasure,suchasaheattreatmentprovidingfora6Dor12Dreduction,butdependsalsoontheinitiallevelbeforethetreatment.,三、FSO的工作原理,加工标准（Processcriterion）：一个实现执行标准的控制参数。例如，蛋白水解肉毒(杆)菌的煮沸须121C20分钟；无蛋白水解肉毒(杆)菌的煮沸须121C10分钟；巴斯德杀菌应为70C2分钟。Processcriterionacontrolparameter(e.g.time,temperature,pH,awwateractivity)atastepthatcanbeappliedtoachieveaperformancecriterion.Exampleprocesscriteria20minutesat121CforproteolyticC.botulinumcook10minat90Cfornon-proteolyticC.botulinumcook2minutesat70Cforpasteurisation,三、FSO的工作原理,了解FSO、PO、CM、PC的概念后，就能理解FSO的工作原理。,三、FSO的工作原理,botulinum减少12log,pH控制在4.6以下,巴斯德杀菌70C度2分钟。,Aconcentrationofsalmonellaeinpowderedmilkbelow1cfu/100g.,pathogenicE.coli在包装果汁中不超过1cfu/10升,FromLeonGorris,FromMartinCole,三、FSO的建立,（一）建立与执行FSO的科学考ScientificconsiderationsforestablishingAndimplementingFSO；（二）利用FSO方法，建立降低食源性李氏特病的案例分析CaseStudy-useoffoodsafetyobjectivesasatoolforreducingfoodbornelisteriosis,ScientificconsiderationsforestablishingAndimplementingFSO,(1)所关注的公共卫生问题及对管理需求的鉴别。Identificationofapublichealthconcernandtheneedformanagementactions.(2)风险水平的评估Evaluationofthelevelofrisk(e.g.,byconductingariskassessment).(3)公共卫生目标的清晰度Articulationofthepublicheathgoal.,ScientificconsiderationsforestablishingAndimplementingFSO,(4)实现公共卫生目标的最大暴露水平的确定Determinationofthemaximumlevelofexposurethatwouldachievethepublichealthgoal-thisistheFSO.(5)执行或遵照FSO的可行性的评估EvaluationofthefeasibilityofcomplyingwiththeFSO.(6)FSO在食品企业的执行ImplementationoftheFSObytheindustry.,CaseStudy-useoffoodsafetyobjectivesasatoolforreducingfoodbornelisteriosis,1、关注的公共卫生问题publichealthconcernListeriamonocytogenesisafoodbornepathogenthatcancauselisteriosis.thereareanestimated2500casesoflisteriosisintheUSAperyear。Invasivelisteriosishasanestimatedfatalityrateof2030%ofthosewhobecomeill2、风险水平thelevelofriskManyfoodproductshavebeenlinkedtolisteriosis,includingcold-smokedfish.Dependingontheprocessingplant,between3%and100%ofcold-smokedsalmonsamplescanbepositiveforthepathogenin25gsamples.,CaseStudy-useoffoodsafetyobjectivesasatoolforreducingfoodbornelisteriosis,3、公共卫生目标thepublicheathgoalIntheUSA,apublichealthobjectiveof0.25casesoflisteriosisper100,000populationperyearhasbeenproposed（(HealthyPeople2010）AnALOPforaninfectiousagentshouldnotbeviewedasanabsoluteendpoint,i.e.,onceitisachieved,thereshouldbecontinuedeffortstoreducetheimpactofthediseaseonpublichealth,CaseStudy-useoffoodsafetyobjectivesasatoolforreducingfoodbornelisteriosis,4、确定实现公共卫生目标的最大暴露水平Determinationofthemaximumlevelofexposure(FSO)-Atotalof80,000tonsperyearofcold-smokedsalmonareconsumedbythenations-Thecombinedpopulationofthesecountriesissome880millionpeople.,CaseStudy-useoffoodsafetyobjectivesasatoolforreducingfoodbornelisteriosis,-Ifweassumethattheaverageservingsizeis60g,wecancalculatethatinoneyearthepopulationconsumesatotalof1330millionservings(80,000/60);about1.5servingsperpersonperyear(1330/880).-TheFAO/WHOriskassessmentonL.monocytogenesinRTEfoods(2004)estimatestheriskoflisteriosisperservingofsmokedfishtobehigh(2.110-8casesperserving).,CaseStudy-useoffoodsafetyobjectivesasatoolforreducingfoodbornelisteriosis,-118servingsperyear,fromwhichtheriskrangeisfrom2.110-8to37.810-8.1(2.110-8casesperserving)2.110-8;18(2.110-8)casesperserving)37.810-8or0.03710-5-WHO/FAOteamconcludedthat99%ofalllisteriosiscaseswouldbeeliminatediflevelsofL.monocytogenes(L.m.)werekeptbelow1000cfuL.m./gatpointofconsumption(RTE)assumingaconsumptionpatternequivalenttothatoftheUSA.,CaseStudy-useoffoodsafetyobjectivesasatoolforreducingfoodbornelisteriosis,-SettingafoodsafetyobjectiveforL.monoc