美国食品安全现代法 黄耀文Food-Safey-Modernizaion-Ac-How-Can

Yao-wenHuangProfessorUniversityofGeorgiaAthens,Georgia,USAShanghaiJiaoTongUniversityShanghai,PRC黄耀文教授美国佐治亚大学食品科学与技术系，食品安全中心与纳米科学工程中心教授。上海交通大学客座教授及陆伯勋食品安全研究中心顾问美国药品监督管理协会认定的HACCP和SSOP培训师美国国家餐饮协会认定的食品安全卫生培训检查员，美国药品监督管理局及佐治亚州农业厅认定的海产食品加工厂审核专员Food-borneIllnessinUS美国食源性疾病Food-borneillnessesconcernconsumers,government,andindustry食源性疾病关系到消费者，政府，企业CDCestimatesonfood-borneillnesses:

疾病预防控制中心关于食品导致的疾病的统计数据:3,000Americandeathsannually48million(or1in6)contractfood-borneillnessannuallyFDAinspectsonly1%ofimportedfood

Monetarycostsofillness经济损失:$35billionannually3TheU.S.foodsupplyisfacinganincreasingamountofthreatsfrombothinternalandexternalsources

食品供应面临

不断增长的威胁,包括内部的与外部的Developingcountriesareexportingmorefoodproductsandingredientsfromsourcesthatarelargelyunregulated

发展中国家出口更多的食品与原料，大量的是不规范的60%ofproduce&vegetablesareimported80%ofseafoodimportedEvolvingFoodSafetyFrameworks食品安全架构的革新Duringthepast15yearstherehasbeenaslowevolutiontoamorequantitative,systems-basedframeworkthatreliesmoreheavilyon过去15年的革新Riskanalysis风险分析Biologicalbasisforadverseeffects微生物的影响Diseaseattribution疾病归因Riskprioritization风险优先“Systemsthinking”系统分析EvolvingFoodSafetyFrameworksExpert-based基于专家→科学数据Science-basedHazard-based基于危害分析→基于风险分析Risk-basedQualitative定性→Quantitative定量CommandandControl指令与控制→HACCP-based危害分析与关键控制点Unstatedregulatorygoals法规规定→Quantitativeperformance-basedcriteria标准Reactive反应→Preventative预防ChangingFoodSafetyLandscapeFDAModernizationAct食品现代化法案FocusontheGlobalSupplyChain关注全球供应链“UniversalAdoption”ofHACCP全球接受”危害分析和关键控制点”WTOSPSAgreement关于实施动植物卫生检疫措施的协议EmergingRoleofInternationalStandardsCodexAlimentariusISO22000食品安全管理体系EmergenceofRiskAnalysisandRiskManagementMetricsConceptsChangingFoodSafetyLandscapeOneoftherecognizedchallengesfacingthefoodindustry,theirregulators,consumers,publichealthcommunity,andacademiciansworldwideis公认的变化：thetransitionfromahazard-basedfoodsafetysystemtoonethatisrisk-based风险评估代替危害分析为基础的食品安全DefinitionsHazards-based危害分析ThemerepresenceofahazardisgroundsforconsideringafoodunsafeRisk-based风险分析Considertheprobablyandlikelyconsequencesofanexposuretodetermineifafoodisunsafe10MainElementsoftheNewLaw新法律的关键要素 1.NewResponsibilitiesforFoodCompanies食品公司的新职责 2.NewControlsonImports进口上的新控制 3.NeworEnhancedFDAEnforcementPowers新的或加强的FDA权力 4.NewFeesonFoodCompaniesandImporters食品公司与进口商的新费用111.NewResponsibilitiesforFoodCompanies食品公司的的新职责Affectingdailyoperations日常操作FoodSafetyPlans/PreventiveControls食品安全计计划/预防防控制SupplyChainManagement供应链管理理RecordsMaintenanceandAccess记录的维护护与使用FoodDefensePlans食品安全防防护计划AppliestoallRegisteredFacilities适用于所有有登记注册册的工厂12HazardAnalysisandPreventiveControls(1)危害分析与与预防控制制Conductanalysisofhazardsreasonablylikelytooccur分析可能发发生的危害害Establishcontrolstosignificantlyreduceorpreventthosehazards建立怎样降降低，减少少危害的控控制方法Implementpreventivecontrolsthroughmonitoring,correctiveactions,andverificationactivities描述监控程程序、采取取纠偏行动动程序、验验证活动13HazardAnalysisandPreventiveControls(2)Verificationactivitiesincludeenvironmentalandfinishedproducttesting验证包括：：环境、最最终产品检检测Re-analysisrequiredevery3years至少3年进行行一次再评估估和复审FoodsafetyplanandrelatedrecordsavailabletoFDAduringinspection在FDA视察察时，能提供供安全计划、、相关记录14TypesofControlsDefined(1)控制类型的说说明Sanitationforfoodcontactsurfacesandutensils,includingfoodcontactsurfacesofequipment食品接触表面面、器具以及及设备的食品品接触面的消消毒程序Supervisor,manager,andemployeetraining管理者、经理理和员工的卫卫生培训Environmentalmonitoringprogram环境监控程序序15TypesofControlsDefined(2)Foodallergencontrolprogram过敏原控制Recallplan召回计划CurrentGoodManufacturingPractices良好的操作规规范Supplierverificationactivitiesthatrelatetothesafetyoffood供应商验证16Exemptions豁免DeemedcomplianceforseafoodHACCP,juiceHACCP,andLowAcidCannedFoodfacilities海产品、果汁汁、低酸性罐罐头食品Limitedexemptionforverysmallbusinesseswithsaleslessthan$500,000,wheremajorityoffoodisdistributeddirectlytoconsumersorrestaurants,anddistributionisintrastateorwithin275mileradius规模较小的农农场主和小型型食品供应商商17ExemptionsFDAhasauthoritytomodifyrulesorexempt–Warehousesforpackagedfood–Storagefacilitiesforrawagriculturalcommodities–Animalfoodorfeed对生产动物饲饲料、未加工工果蔬、储存存企业有变通通，在农场生生产包装储存存的企业酌情情处理18IntentionallyIntroducedHazards可能故意引入入的危害Hazardsthatmaybeintroducedbyactsofterrorismincludedinhazardsanalysis恐怖行为可能能引入的危害害分析Implementappropriatemitigationsteps采用适当的降降低发生恐怖怖活动的措施施192.NewControlsOverImportedFoodFDA对输美美食品开展检检查已知的进口食食品的安全风风险；已知的原产国国或地区、运运输国的安全全风险；进口商遵守法法规的历史，，包括食品召召回、食源性性疾病暴发、、违反食品安安全标准方面面的情况；进口商在满足足国外供应商商验证项目方方面行为的严严格程度和效效果；食品进口商是是否参加自愿愿性合格进口口商项目；食品是否符合合801（h）(1)规规定的优先标标准；食品或者生产产、加工、包包装、储存食食品的企业是是否获得相关关证明；FDA认为必必要且适宜的的其他标准203.NeworEnhancedEnforcementPowersforFDAIncreasedinspectionfrequency扩大监管责任任–HighRiskDomestic–every3years–LowRiskDomestic–every5years–RampupForeigninspections(600to9,600over5years)Suspensionofregistration（加强食品企企业注册要求求）Mandatoryrecall（强制召回））Expandedadministrativedetentionauthority扩大行政滞留留权力（a）总则——根据第201节的修订，对对第四章（21U.S.C.341etseq）进行修订，，在结尾处增增加：第422节食品实实验室认可（a）实验室认可可的承认——（1）总则——《FDA食品安全现代代化法》生效之日起2年内，部长应应-（A）为认可的实实验室食品检检测建立程序序；（B）创建公众可可查阅的部长长承认的认可可机构和认可可机构认可的的实验室登记记表，包括名名称、联系方方式及部长认认为有必要的的其它信息；；同时（C）作为承认或或认可条件之之一，要求承承认的认可机机构以及认可可实验室向部部长报告任何何可能影响该该认可机构或或认可实验室室获得承认的的改动。食品实验室认认可（第202章节）本节主要增加加了“第422节食品分析析实验室的认认可”的内容容。美国国内内外食品实验验室均应由获获得FDA承认的认可机机构认可，同同时FDA要推动食品应应急反应网络络的建设。食品分析实验验室检测主要要用于货主、、收货人对某某一特定检测测要求做出的的反应，或是是当为解决某某一已确定或或怀疑的食品品安全问题而而执行规定；；或支持某食食品的入境；；以及根据进进口警示，要要求连续检测测。《FDA食品安全现代代化法》生效之日起2年内，FDA应建立食品分分析实验室认认可程序和标标准。FDA承认的认可机机构可以对美美国之外的实实验室进行认认证，只要该该实验室能够够达到本节对对美国本土实实验室的认可可标准。FDA食品安全现代代化法颁布后后30个月内，食品品检测应由获获得认可的联联邦或非联邦邦实验室进行行，这些实验验室的抽样、、分析检测方方法经由FDA所确定的名录录中认可机构构认可。任何何这种检测结结果应直接送送至FDA。244.NewFeesonFoodCompaniesandImporters食品企业及进进口商新产生生的费用ReimbursementtoFDARe-inspections复验Recall(verylimited)需要召回的Exportcertificates出口证明（第第三方认证））Fastlaneforimports快速审批和进进口程序（参加自愿性合合格进口商项项目的进口商商收费）Notethatre-inspectionfeesandexportcertificatefeesmaystartin2011ImplementationTimeline执行行时时间间26ImplementationTimelinesVariouseffectivedatesfordifferentprovisionsBasictimeline–18months–foodsafetyplans–24months–foreignsupplierverification国外外供供应应商商的的验验证证–Longerfortraceability–Bi-annualregistrationbegins2012每两两年年一一次次的的注注册册27ImplementationTimetableProvisionsimmediatelyeffective立即即生生效效的的–MandatoryRecall强制制召召回回–RecordsAccessunderBioterrorismLawHowtoPreparefortheNewLaw如何何应应对对新新法法29HowtoPrepare?FoodSafetyPlans食品品安安全全计计划划(andFoodDefensePlans食品品防防护护计计划划)•Hazardanalysis危害害分分析析•Preventivecontrols预防防控控制制•Verification,includingtesting验证证，，测测试试Supplychainmanagement供应应链链管管理理•Domestic国内内•Foreign国外外–Recordsmaintenanceandaccess记录录的的维维护护•Routine日常常的的•UnderBioterrorismAct恐怖怖行行为为30FoodSafetyPlans–HazardAnalysis危害害分分析析Forhazardsthatmayoccurnaturallyormaybeunintentionallyintroduced,identifyandevaluate:Biological生物物的的Chemical化学学的的Physical物理理的的Radiological放射射性性Naturaltoxins天然然毒毒素素Pesticides杀虫虫剂剂Drugresidues药物残留留Decomposition腐败变质质Parasites寄生虫Allergens过敏原Unapprovedfoodandcoloradditives未必批准准的食品品及色素素添加剂剂31FoodSafetyPlans食品安全全计划Reviewyourcompany’splan回顾公司司的计划划:Whenwasthelasttimeweanalyzedpotentialhazards?上次分析析潜在危危害的时时间Hasyourfacilityundergoneanysignificantchangessincethen?从那时起起，设施施是否有有明显变变化Doyouanticipatemakingsignificantchangesinthenearfuture?近期有没没有打算算进行明明显的调调整Whatpreventivecontrolsareyouusing?你使用什什么预防防控制措措施Doyouhaveanycriticalcontrolpoints?有关键控控制点么么？32FoodSafetyPlansReviewyourcompany’splanHaveyouverifiedthesecontrolsareeffective?是否验证证这些控控制措施施的持续续有效Whatmonitoringactivitiesareyouperforming?如何监控控？Aretheseappropriatelydocumented?这些适当当的文件件化了么么？Doyouhaveproceduresinplacetodeterminewhencorrectiveactionsareneededandwhatkindtotake?有没有制制定什么么时候采采用纠偏偏措施，，采用什什么纠偏偏措施Isthisdocumented?文件规定定了么？？33FoodSafetyPlans–Verification验证Operatormustverifythat管理者必必须验证证Preventivecontrolsareadequatetoaddresstheidentifiedhazards预防控制制措施必必须足以以处理识识别的危危害Monitoringofthecontrolsisinplace控制措措施的的监控控必须须适当当Appropriatedecisionsarebeingmaderegardingcorrectiveactions针对纠纠正活活动采采取适适当的的措施施34FoodSafetyPlans–Verification验证Operatormustverifythat(1)Preventivecontrolsareeffectivelyandsignificantlyminimizingorpreventingtheoccurrenceofidentifiedhazards预防控控制是是有效效的，，能够够显著著减小小或阻阻止已已识别别的危危害的的发生生“includingthroughtheuseofenvironmentalandproducttestingprogramsandotherappropriatemeans”包括通通过利利用环环境监监控与与产品品检测测，及及其他他合适适的方方法35FoodSafetyPlans–VerificationOperatormustverifythat(2)Documented,periodicreanalysisofthehazardplantoensureitisstillrelevanttothefacilityandtonewandemergingthreats定期重重新评评估危危害分分析计计划，，确保保始终终适用用于设设备与与新的的危机机36SupplyChainManagementDomesticsuppliers国内供供应商商–Supplierverificationactivitiesareincludedasonetypeofpreventivecontrol供应商商验证证包含含在预预防控控制活活动中中Foreignsuppliers国外供供应商商–Subjecttotheforeignsupplierverificationprogram遵守国国外供供应商商计划划37SupplyChainManagement–ForeignSuppliersForeignSupplierVerificationProgram国外供供应商商审核核计划划Eachimportershallperformrisk-basedforeignsupplierverificationactivitiesforthepurposeofverifyingthatthefoodimportedbytheimporteris各进口商应应执行基于于风险的国国外供应商商审核活动动，从而证证明所进口口的食物：：ProducedincompliancewiththeFoodSafetyPlanrequirements生产符合食食品安全计计划要求ProducedincompliancewithproducesafetyregulationstobepromulgatedbyFDA生产符合FDA颁布布的产品安安全规章Notadulteratedormisbranded不是掺假食食品或者贴贴错标签的的食品38SupplyChainManagement–ForeignSuppliersVerificationactivitiesmayinclude国外供应商商的审核活活动可包括括:Monitoringrecordsforshipments监测出货记记录Lot-by-lotcertificationofcompliance逐批合格证证明Annualon-siteinspections年度实地检检验Checkingthehazardanalysisandrisk-basedpreventivecontrolplanoftheforeignsupplier检查危害分分析与基于于风险预防防控制计划划Periodicallytestingandsamplingshipments定期检测与与抽样出货货39SupplyChainManagement–ForeignSuppliersException–TheforeignsupplierverificationprogramdoesnotapplytoseafoodandjuicefacilitiesthatalreadymustcomplywithHACCPregulations,ormicrobiologicalelementsofLACFregulations豁免-已经经应用HACCP的的海产品，，果汁以及及低酸性罐罐头的微生生物元素Exception豁免–Programalsodoesnotapplytosmallquantitiesimportedforresearchandevaluationpurposes(i.e.,productsamples)orforpersonalconsumption豁免-用于于研究和评评估（产品品样品）的的小量进口口，个人消消费的40SupplyChainManagementReviewyourinventoryofdomesticandforeignsuppliers回顾国内与与国外供应应商的目录录Doyouknowwhoyoursuppliersare,evenifbrokersordistributorsareused?是否知道自自己的供应应商是谁，，以及使用用的经销商商或代理商商？41SupplyChainManagementReviewyourcompany’ssupplierverificationprocedures回顾公司的的供应商审审核程序Whatareyourprocedurestoqualifyingredientsuppliers?你评估原料料供应的程