美国食品安全现代法 黄耀文Food-Safety-Modernization-Act-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食品公司的新职责Affectingdailyoperations日常操作FoodSafetyPlans/PreventiveControls食品安全计划/预防控制SupplyChainManagement供应链管理RecordsMaintenanceandAccess记录的维护与使用FoodDefensePlans食品安全防护计划AppliestoallRegisteredFacilities适用于所有登记注册的工厂12HazardAnalysisandPreventiveControls(1)危害分析与预防控制Conductanalysisofhazardsreasonablylikelytooccur分析可能发生的危害Establishcontrolstosignificantlyreduceorpreventthosehazards建立怎样降低，减少危害的控制方法Implementpreventivecontrolsthroughmonitoring,correctiveactions,andverificationactivities描述监控程序、采取纠偏行动程序、验证活动13HazardAnalysisandPreventiveControls(2)Verificationactivitiesincludeenvironmentalandfinishedproducttesting

验证包括：环境、最终产品检测Re-analysisrequiredevery3years

至少3年进行一次再评估和复审FoodsafetyplanandrelatedrecordsavailabletoFDAduringinspection

在FDA视察时，能提供安全计划、相关记录14TypesofControlsDefined(1)控制类型的说明Sanitationforfoodcontactsurfacesandutensils,includingfoodcontactsurfacesofequipment食品接触表面、器具以及设备的食品接触面的消毒程序Supervisor,manager,andemployeetraining

管理者、经理和员工的卫生培训Environmentalmonitoringprogram

环境监控程序15TypesofControlsDefined(2)Foodallergencontrolprogram过敏原控制Recallplan召回计划CurrentGoodManufacturingPractices良好的操作规范Supplierverificationactivitiesthatrelatetothesafetyoffood供应商验证16Exemptions豁免DeemedcomplianceforseafoodHACCP,juiceHACCP,andLowAcidCannedFoodfacilities海产品、果汁、低酸性罐头食品Limitedexemptionforverysmallbusinesseswithsaleslessthan$500,000,wheremajorityoffoodisdistributeddirectlytoconsumersorrestaurants,anddistributionisintrastateorwithin275mileradius规模较小的农场主和小型食品供应商17ExemptionsFDAhasauthoritytomodifyrulesorexempt

–Warehousesforpackagedfood

–Storagefacilitiesforrawagriculturalcommodities

–Animalfoodorfeed对生产动物饲料、未加工果蔬、储存企业有变通，在农场生产包装储存的企业酌情处理18IntentionallyIntroducedHazards可能故意引入的危害Hazardsthatmaybeintroducedbyactsofterrorismincludedinhazardsanalysis

恐怖行为可能引入的危害分析Implementappropriatemitigationsteps

采用适当的降低发生恐怖活动的措施192.NewControlsOverImportedFood

FDA对输美食品开展检查已知的进口食品的安全风险；已知的原产国或地区、运输国的安全风险；进口商遵守法规的历史，包括食品召回、食源性疾病暴发、违反食品安全标准方面的情况；进口商在满足国外供应商验证项目方面行为的严格程度和效果；食品进口商是否参加自愿性合格进口商项目；食品是否符合801（h）(1)规定的优先标准；食品或者生产、加工、包装、储存食品的企业是否获得相关证明；FDA认为必要且适宜的其他标准203.NeworEnhancedEnforcementPowersforFDAIncreasedinspectionfrequency扩大监管责任

–HighRiskDomestic–every3years

–LowRiskDomestic–every5years

–RampupForeigninspections (600to9,600over5years)Suspensionofregistration（加强食品企业注册要求）Mandatoryrecall（强制召回）Expandedadministrativedetention

authority扩大行政滞留权力（a）总则——根据第201节的修订，对第四章（21U.S.C.341etseq）进行修订，在结尾处增加：第422节食品实验室认可（a）实验室认可的承认——（1）总则——《FDA食品安全现代化法》生效之日起2年内，部长应-

（A）为认可的实验室食品检测建立程序；（B）创建公众可查阅的部长承认的认可机构和认可机构认可的实验室登记表，包括名称、联系方式及部长认为有必要的其它信息；同时（C）作为承认或认可条件之一，要求承认的认可机构以及认可实验室向部长报告任何可能影响该认可机构或认可实验室获得承认的改动。食品实验室认可（第202章节）本节主要增加了“第422节食品分析实验室的认可”的内容。美国国内外食品实验室均应由获得FDA承认的认可机构认可，同时FDA要推动食品应急反应网络的建设。食品分析实验室检测主要用于货主、收货人对某一特定检测要求做出的反应，或是当为解决某一已确定或怀疑的食品安全问题而执行规定；或支持某食品的入境；以及根据进口警示，要求连续检测。《FDA食品安全现代化法》生效之日起2年内，FDA应建立食品分析实验室认可程序和标准。FDA承认的认可机构可以对美国之外的实验室进行认证，只要该实验室能够达到本节对美国本土实验室的认可标准。FDA食品安全现代化法颁布后30个月内，食品检测应由获得认可的联邦或非联邦实验室进行，这些实验室的抽样、分析检测方法经由FDA所确定的名录中认可机构认可。任何这种检测结果应直接送至FDA。244.NewFeesonFoodCompaniesandImporters食品企业及进口商新产生的费用ReimbursementtoFDARe-inspections复验Recall(verylimited)需要召回的Exportcertificates出口证明（第三方认证）Fastlaneforimports快速审批和进口程序（参加自愿性合格进口商项目的进口商收费）Notethatre-inspectionfeesandexportcertificatefeesmaystartin2011ImplementationTimeline

执行时间26ImplementationTimelinesVariouseffectivedatesfordifferentprovisionsBasictimeline

–

18months–foodsafetyplans

–24months–foreignsupplier

verification国外供应商的验证

–Longerfortraceability

–Bi-annualregistrationbegins2012每两年一次的注册27ImplementationTimetableProvisionsimmediatelyeffective立即生效的

–

MandatoryRecall强制召回

– RecordsAccessunderBioterrorismLawHowtoPreparefortheNewLaw如何应对新法29HowtoPrepare?FoodSafetyPlans食品安全计划(andFoodDefensePlans食品防护计划)

• Hazardanalysis危害分析

• Preventivecontrols预防控制

• Verification,includingtesting验证，测试Supplychainmanagement供应链管理

• Domestic国内

• Foreign国外–

Recordsmaintenanceandaccess记录的维护

•

Routine日常的

• UnderBioterrorismAct恐怖行为

30FoodSafetyPlans–HazardAnalysis危害分析Forhazardsthatmayoccurnaturallyormaybeunintentionallyintroduced,identifyandevaluate:Biological生物的

Chemical化学的

Physical物理的

Radiological放射性

Naturaltoxins天然毒素

Pesticides杀虫剂Drugresidues药物残留

Decomposition腐败变质

Parasites寄生虫

Allergens过敏原

Unapprovedfoodand

coloradditives未必批准的食品及色素添加剂31FoodSafetyPlans食品安全计划Reviewyourcompany’splan回顾公司的计划:Whenwasthelasttimeweanalyzedpotentialhazards?

上次分析潜在危害的时间Hasyourfacilityundergoneanysignificantchangessincethen?从那时起，设施是否有明显变化Doyouanticipatemakingsignificantchangesinthenearfuture?近期有没有打算进行明显的调整Whatpreventivecontrolsareyouusing?你使用什么预防控制措施Doyouhaveanycriticalcontrolpoints?有关键控制点么？32FoodSafetyPlansReviewyourcompany’splanHaveyouverifiedthesecontrolsareeffective?是否验证这些控制措施的持续有效Whatmonitoringactivitiesareyouperforming?如何监控？Aretheseappropriatelydocumented?这些适当的文件化了么？Doyouhaveproceduresinplacetodeterminewhencorrectiveactionsareneededandwhatkindtotake?有没有制定什么时候采用纠偏措施，采用什么纠偏措施Isthisdocumented?文件规定了么？33FoodSafetyPlans–Verification验证Operatormustverifythat管理者必须验证Preventivecontrolsareadequatetoaddresstheidentifiedhazards预防控制措施必须足以处理识别的危害Monitoringofthecontrolsisinplace控制措施的监控必须适当Appropriatedecisionsarebeingmaderegardingcorrectiveactions针对纠正活动采取适当的措施34FoodSafetyPlans–Verification验证Operatormustverifythat(1)Preventivecontrolsareeffectivelyandsignificantlyminimizingorpreventingtheoccurrenceofidentifiedhazards

预防控制是有效的，能够显著减小或阻止已识别的危害的发生“includingthroughtheuseofenvironmentalandproducttestingprogramsandotherappropriatemeans”包括通过利用环境监控与产品检测，及其他合适的方法35FoodSafetyPlans–VerificationOperatormustverifythat(2)Documented,periodicreanalysisofthehazardplantoensureitisstillrelevanttothefacilityandtonewandemergingthreats

定期重新评估危害分析计划，确保始终适用于设备与新的危机36SupplyChainManagementDomesticsuppliers国内供应商

–Supplierverificationactivitiesareincludedasonetypeofpreventivecontrol供应商验证包含在预防控制活动中Foreignsuppliers国外供应商

–Subjecttotheforeignsupplierverificationprogram遵守国外供应商计划37SupplyChainManagement–ForeignSuppliersForeignSupplierVerificationProgram国外供应商审核计划Eachimportershallperformrisk-basedforeignsupplierverificationactivitiesforthepurposeofverifyingthatthefoodimportedbytheimporteris各进口商应执行基于风险的国外供应商审核活动，从而证明所进口的食物：ProducedincompliancewiththeFoodSafetyPlanrequirements生产符合食品安全计划要求ProducedincompliancewithproducesafetyregulationstobepromulgatedbyFDA生产符合FDA颁布的产品安全规章Notadulteratedormisbranded不是掺假食品或者贴错标签的食品38SupplyChainManagement–ForeignSuppliers

Verificationactivitiesmayinclude国外供应商的审核活动可包括:Monitoringrecordsforshipments监测出货记录Lot-by-lotcertificationofcompliance逐批合格证明Annualon-siteinspections年度实地检验Checkingthehazardanalysisandrisk-basedpreventivecontrolplanoftheforeignsupplier检查危害分析与基于风险预防控制计划Periodicallytestingandsamplingshipments定期检测与抽样出货39SupplyChainManagement–ForeignSuppliers

Exception–TheforeignsupplierverificationprogramdoesnotapplytoseafoodandjuicefacilitiesthatalreadymustcomplywithHACCPregulations,ormicrobiologicalelementsofLACFregulations豁免-已经应用HACCP的海产品，果汁以及低酸性罐头的微生物元素

Exception豁免–Programalsodoesnotapplytosmallquantitiesimportedforresearchandevaluationpurposes(i.e.,productsamples)orforpersonalconsumption豁免-用于研究和评估（产品样品）的小量进口，个人消费的40SupplyChainManagementReviewyourinventoryofdomesticandforeignsuppliers回顾国内与国外供应商的目录Doyouknowwhoyoursuppliersare,evenifbrokersordistributorsareused?是否知道自己的供应商是谁，以及使用的经销商或代理商？41SupplyChainManagementReviewyourcompany’ssupplierverificationprocedures回顾公司的供应商审核程序Whatareyourprocedurestoqualifyingredientsuppliers?你评估原料供应的程序是怎样的？Whatdoyoudotoaudityoursuppliers?如何审查你的供