美国食品安全现代法黄耀文Food-Safety-Modernization-Act-How-Can

Yao-wenHuangProfessorUniversityofGeorgiaAthens,Georgia,USAShanghaiJiaoTongUniversityShanghai,PRC第1页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HACCP和SSOP培训师美国国家餐饮协会认定食品安全卫生培训检验员，美国药品监督管理局及佐治亚州农业厅认定海产食品加工厂审核专员第2页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造成疾病统计数据:3,000Americandeathsannually48million(or1in6)contractfood-borneillnessannuallyFDAinspectsonly1%ofimportedfood

Monetarycostsofillness经济损失:$35billionannually3第3页TheU.S.foodsupplyisfacinganincreasingamountofthreatsfrombothinternalandexternalsources

食品供给面临

不停增加威胁,包含内部与外部Developingcountriesareexportingmorefoodproductsandingredientsfromsourcesthatarelargelyunregulated

发展中国家出口更多食品与原料，大量是不规范60%ofproduce&vegetablesareimported80%ofseafoodimported第4页EvolvingFoodSafetyFrameworks食品安全架构革新Duringthepast15yearstherehasbeenaslowevolutiontoamorequantitative,systems-basedframeworkthatreliesmoreheavilyon过去革新Riskanalysis风险分析Biologicalbasisforadverseeffects微生物影响Diseaseattribution疾病归因Riskprioritization风险优先“Systemsthinking”系统分析第5页EvolvingFoodSafetyFrameworksExpert-based基于教授→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法规要求→Quantitativeperformance-basedcriteria标准Reactive反应→Preventative预防第6页ChangingFoodSafetyLandscapeFDAModernizationAct食品当代化法案FocusontheGlobalSupplyChain关注全球供给链“UniversalAdoption”ofHACCP全球接收”危害分析和关键控制点”WTOSPSAgreement关于实施动植物卫生检疫办法协议EmergingRoleofInternationalStandardsCodexAlimentariusISO2食品安全管理体系EmergenceofRiskAnalysisandRiskManagementMetricsConcepts第7页ChangingFoodSafetyLandscapeOneoftherecognizedchallengesfacingthefoodindustry,theirregulators,consumers,publichealthcommunity,andacademiciansworldwideis公认改变：thetransitionfromahazard-basedfoodsafetysystemtoonethatisrisk-based风险评定代替危害分析为基础食品安全第8页DefinitionsHazards-based危害分析ThemerepresenceofahazardisgroundsforconsideringafoodunsafeRisk-based风险分析Considertheprobablyandlikelyconsequencesofanexposuretodetermineifafoodisunsafe第9页10MainElementsoftheNewLaw新法律关键要素 1.NewResponsibilitiesforFoodCompanies食品企业新职责 2.NewControlsonImports进口上新控制 3.NeworEnhancedFDAEnforcementPowers新或加强FDA权力 4.NewFeesonFoodCompaniesandImporters食品企业与进口商新费用第10页111.NewResponsibilitiesforFoodCompanies食品企业新职责Affectingdailyoperations日常操作FoodSafetyPlans/PreventiveControls食品安全计划/预防控制SupplyChainManagement供给链管理RecordsMaintenanceandAccess统计维护与使用FoodDefensePlans食品安全防护计划AppliestoallRegisteredFacilities适合用于全部登记注册工厂第11页12HazardAnalysisandPreventiveControls(1)危害分析与预防控制Conductanalysisofhazardsreasonablylikelytooccur分析可能发生危害Establishcontrolstosignificantlyreduceorpreventthosehazards建立怎样降低，降低危害控制方法Implementpreventivecontrolsthroughmonitoring,correctiveactions,andverificationactivities描述监控程序、采取纠偏行动程序、验证活动第12页13HazardAnalysisandPreventiveControls(2)Verificationactivitiesincludeenvironmentalandfinishedproducttesting

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

最少3年进行一次再评定和复审FoodsafetyplanandrelatedrecordsavailabletoFDAduringinspection

在FDA视察时，能提供安全计划、相关统计第13页14TypesofControlsDefined(1)控制类型说明Sanitationforfoodcontactsurfacesandutensils,includingfoodcontactsurfacesofequipment食品接触表面、器具以及设备食品接触面消毒程序Supervisor,manager,andemployeetraining

管理者、经理和员工卫生培训Environmentalmonitoringprogram

环境监控程序第14页15TypesofControlsDefined(2)Foodallergencontrolprogram过敏原控制Recallplan召回计划CurrentGoodManufacturingPractices良好操作规范Supplierverificationactivitiesthatrelatetothesafetyoffood供给商验证第15页16Exemptions豁免DeemedcomplianceforseafoodHACCP,juiceHACCP,andLowAcidCannedFoodfacilities海产品、果汁、低酸性罐头食品Limitedexemptionforverysmallbusinesseswithsaleslessthan$500,000,wheremajorityoffoodisdistributeddirectlytoconsumersorrestaurants,anddistributionisintrastateorwithin275mileradius规模较小农场主和小型食品供给商第16页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企业酌情处理第17页18IntentionallyIntroducedHazards可能有意引入危害Hazardsthatmaybeintroducedbyactsofterrorismincludedinhazardsanalysis

恐怖行为可能引入危害分析Implementappropriatemitigationsteps

采取适当降低发生恐怖活动办法第18页192.NewControlsOverImportedFood

FDA对输美食品开展检验已知进口食品安全风险；已知原产国或地域、运输国安全风险；进口商恪遵法规历史，包含食品召回、食源性疾病暴发、违反食品安全标准方面情况；进口商在满足国外供给商验证项目方面行为严格程度和效果；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)要求优先标准；食品或者生产、加工、包装、储存食品企业是否取得相关证实；FDA认为必要且适宜其它标准第19页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扩大行政滞留权力第20页（a）总则——依据第201节修订，对第四章（21U.S.C.341etseq）进行修订，在结尾处增加：第422节食品试验室认可（a）试验室认可认可——（1）总则——《FDA食品安全当代化法》生效之日起2年内，部长应-

（A）为认可试验室食品检测建立程序；（B）创建公众可查阅部长认可认可机构和认可机构认可试验室记录表，包含名称、联络方式及部长认为有必要其它信息；同时（C）作为认可或认可条件之一，要求认可认可机构以及认可试验室向部长汇报任何可能影响该认可机构或认可试验室取得认可改动。食品试验室认可（第202章节）第21页本节主要增加了“第422节食品分析试验室认可”内容。美国国内外食品试验室均应由取得FDA认可认可机构认可，同时FDA要推进食品应急反应网络建设。食品分析试验室检测主要用于货主、收货人对某一特定检测要求做出反应，或是当为处理某一已确定或怀疑食品安全问题而执行要求；或支持某食品入境；以及依据进口警示，要求连续检测。第22页《FDA食品安全当代化法》生效之日起2年内，FDA应建立食品分析试验室认可程序和标准。FDA认可认可机构能够对美国之外试验室进行认证，只要该试验室能够到达本节对美国本土试验室认可标准。FDA食品安全当代化法颁布后30个月内，食品检测应由取得认可联邦或非联邦试验室进行，这些试验室抽样、分析检测方法经由FDA所确定名目中认可机构认可。任何这种检测结果应直接送至FDA。第23页244.NewFeesonFoodCompaniesandImporters食品企业及进口商新产生费用ReimbursementtoFDARe-inspections复验Recall(verylimited)需要召回Exportcertificates出口证实（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标进口商收费）Notethatre-inspectionfeesandexportcertificatefeesmaystartin第24页ImplementationTimeline

执行时间第25页26ImplementationTimelinesVariouseffectivedatesfordifferentprovisionsBasictimeline

–

18months–foodsafetyplans

–24months–foreignsupplier

verification国外供给商验证

–Longerfortraceability

–Bi-annualregistrationbegins每两年一次注册第26页27ImplementationTimetableProvisionsimmediatelyeffective马上生效

–

MandatoryRecall强制召回

– RecordsAccessunderBioterrorismLaw第27页HowtoPreparefortheNewLaw怎样应对新法第28页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供给链管理

• Domestic国内

• Foreign国外–

Recordsmaintenanceandaccess统计维护

•

Routine日常

• UnderBioterrorismAct恐怖行为

第29页30FoodSafetyPlans–HazardAnalysis危害分析Forhazardsthatmayoccurnaturallyormaybeunintentionallyintroduced,identifyandevaluate:Biological生物

Chemical化学

Physical物理

Radiological放射性

Naturaltoxins天然毒素

Pesticides杀虫剂Drugresidues药品残留

Decomposition腐败变质

Parasites寄生虫

Allergens过敏原

Unapprovedfoodand

coloradditives未必同意食品及色素添加剂第30页31FoodSafetyPlans食品安全计划Reviewyourcompany’splan回顾企业计划:Whenwasthelasttimeweanalyzedpotentialhazards?

上次分析潜在危害时间Hasyourfacilityundergoneanysignificantchangessincethen?从那时起，设施是否有显著改变Doyouanticipatemakingsignificantchangesinthenearfuture?近期有没有打算进行显著调整Whatpreventivecontrolsareyouusing?你使用什么预防控制办法Doyouhaveanycriticalcontrolpoints?相关键控制点么？第31页32FoodSafetyPlansReviewyourcompany’splanHaveyouverifiedthesecontrolsareeffective?是否验证这些控制办法连续有效Whatmonitoringactivitiesareyouperforming?怎样监控？Aretheseappropriatelydocumented?这些适当文件化了么？Doyouhaveproceduresinplacetodeterminewhencorrectiveactionsareneededandwhatkindtotake?有没有制订什么时候采取纠偏办法，采取什么纠偏办法Isthisdocumented?文件要求了么？第32页33FoodSafetyPlans–Verification验证Operatormustverifythat管理者必须验证Preventivecontrolsareadequatetoaddresstheidentifiedhazards预防控制办法必须足以处理识别危害Monitoringofthecontrolsisinplace控制办法监控必须适当Appropriatedecisionsarebeingmaderegardingcorrectiveactions针对纠正活动采取适当办法第33页34FoodSafetyPlans–Verification验证Operatormustverifythat(1)Preventivecontrolsareeffectivelyandsignificantlyminimizingorpreventingtheoccurrenceofidentifiedhazards

预防控制是有效，能够显著减小或阻止已识别危害发生“includingthroughtheuseofenvironmentalandproducttestingprogramsandotherappropriatemeans”包含经过利用环境监控与产品检测，及其它适当方法第34页35FoodSafetyPlans–VerificationOperatormustverifythat(2)Documented,periodicreanalysisofthehazardplantoensureitisstillrelevanttothefacilityandtonewandemergingthreats

定时重新评定危害分析计划，确保一直适合用于设备与新危机第35页36SupplyChainManagementDomesticsuppliers国内供给商

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

–Subjecttotheforeignsupplierverificationprogram恪守国外供给商计划第36页37SupplyChainManagement–ForeignSuppliersForeignSupplierVerificationProgram国外供给商审核计划Eachimportershallperformrisk-basedforeignsupplierverificationactivitiesforthepurposeofverifyingthatthefoodimportedbytheimporteris各进口商应执行基于风险国外供给商审核活动，从而证实所进口食物：ProducedincompliancewiththeFoodSafetyPlanrequirements生产符合食品安全计划要求ProducedincompliancewithproducesafetyregulationstobepromulgatedbyFDA生产符合FDA颁布产品安全规章Notadulteratedormisbranded不是掺假食品或者贴错标签食品第37页38SupplyChainManagement–ForeignSuppliers

Verificationactivitiesmayinclude国外供给商审核活动可包含:Monitoringrecordsforshipments监测出货统计Lot-by-lotcertificationofcompliance逐批合格证实Annualon-siteinspections年度实地检验Checkingthehazardanalysisandrisk-basedpreventivecontrolplanoftheforeignsupplier检验危害分析与基于风险预防控制计划Periodicallytestingandsamplingshipments定时检测与抽样出货第38页39SupplyChainManagement–ForeignSuppliers

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

Exception豁免–Programalsodoesnotapplytosmallquantitiesimportedforresearchandevaluationpurposes(i.e.,productsamples)orforpersonalconsumption豁免-用于研究和评定（产品样品）小量进口，个人消费第39页40SupplyChainManagementReviewyourinventoryofdomesticandforeignsuppliers回顾国内与国外供给商目录Doyouknowwhoyoursuppliersare,evenifbrokersordistributorsareused?是否知道自己供给商是谁，以及使用经销商或代理商？第40页41SupplyChainManagementReviewyourcompany’ssupplierverificationprocedures回顾企业供给商审核程序Whatareyourprocedurestoqualifyingredientsuppliers?你评定原料供给程序是怎样？Whatdoyoudotoaudityoursuppliers?怎样审查你供给商Whata