FDA水產(chǎn)品HACCP法規(guī)培訓(xùn)中英文

1、FDA水產(chǎn)品HACCP 法規(guī)- 21 CFR 123, 1240FDA水產(chǎn)品HACCP法規(guī)Subpart ADefinitions定義Good ManufacturingPractices （GMP）HazardAnalysis&HazardAnalysisCriticalControlPointplan （HACCP計劃）Corrective Actions糾正措施施Verification驗證Records記錄Training培訓(xùn)Sanitation衛(wèi)生（SSOP）RequirementsofImportedProducts對進口產(chǎn)產(chǎn)品的要要求FDA水產(chǎn)品HACCP法規(guī)Subpart B-

2、SmokedFish煙熏魚FDA水產(chǎn)品HACCP法規(guī)Subpart C-RawMolluscanShellfish生的軟體體貝類FDA水產(chǎn)品HACCP法規(guī)HACCP只適用于于 :食品安全全的危害害FDA水產(chǎn)品HACCP法規(guī)Subpart A適用于所所有加工工者FDA水產(chǎn)品HACCP法規(guī)不受法規(guī)規(guī)制約的的設(shè)施:Fishing Vessels捕撈船TransportationVehicles運輸工具具RetailEstablishments, IncludingRestaurants包括餐館館在內(nèi)的的零售設(shè)設(shè)施FDA水產(chǎn)品HACCP法規(guī)Definitions:Processing加工-Handli

3、ng,storing,preparing,heading,eviscerating, shucking,freezing,changingform,manufacturing,preserving,packing,labeling, dockside unloading,orholding.FDA水產(chǎn)品HACCP法規(guī)Definitions:Fish水產(chǎn)-allformsofaquaticanimallifeintendedforhumanconsumption; includingamphibians,mollusks,and roe.FDA水產(chǎn)品HACCP法規(guī)Definitions:Fish

4、ery Products水產(chǎn)制品品-anyhumanfoodproduct in which fishisthe characterizing ingredient.FDA水產(chǎn)品HACCP法規(guī)Good ManufacturingPractices (GMPs)Ties GMPs HACCP regulationsFDA水產(chǎn)品HACCP法規(guī)IncludesallsevenprinciplesofHACCP七個原則則或原理理:Conducting aHazard Analysis危害分析析IdentifyingCriticalControl Points(CCP)確定關(guān)鍵鍵控制點點Establis

5、hingCriticalLimits建立關(guān)鍵鍵限值Monitoring EachCCP監(jiān)測每個個CCP點EstablishingCorrectiveActions to be Taken WhenaCriticalLimitDeviationOccurs糾正措施施EstablishingaRecord-KeepingSystem記錄保持持系統(tǒng)EstablishingVerification Procedures驗證程序序FDA水產(chǎn)品HACCP法規(guī)Conducting ahazard analysis:Aretherefood safetyhazardsassociated withmyprod

6、uctthat arereasonably likelytooccur?Aretherepreventative measures thatIcanapplytocontrolthesehazards?Hazards aredefined as physical,microbiologicaland/or chemical物理、化化學(xué)與生生物危害害FDA水產(chǎn)品HACCP法規(guī)Hazardmustbeonethatisreasonably likelytooccur極可能發(fā)發(fā)生的危危害FDA水產(chǎn)品HACCP法規(guī)Nooneway to do ahazard analysis進行危害害分析的的途徑很很

7、多Becertain to usetheGuide一定要使使用指指南Nohazards-NoHACCPplan is necessary沒有（顯顯著）危危害，就就不需要要HACCP計劃FDA水產(chǎn)品HACCP法規(guī)TheHACCPPlanEach LocationEach ProductHACCP計劃是針針對于每每一個加加工地點點、每一一種產(chǎn)品品FDA水產(chǎn)品HACCP法規(guī)HACCP計劃必須須包括:TheFoodSafetyHazard食品安全全危害TheCriticalControlPointsofEachHazard每一個危危害的關(guān)關(guān)鍵控制制點TheCriticalLimits關(guān)鍵限值值TheM

8、onitoringProcedures監(jiān)測程序序TheRequiredRecords要求的記記錄A CorrectiveAction糾正措施施TheVerification Procedures驗證程序序FDA水產(chǎn)品HACCP法規(guī)HACCPPlan-Hazards to be considered要考慮到到的危害害:Natural Toxins天然毒素素Microbiological微生物ChemicalPesticides化學(xué)殺蟲蟲劑（農(nóng)藥）Drug Residues藥物（獸獸藥）殘殘留Unapproved UsesofFoodandColorAdditives未經(jīng)批準準使用的的食品添添加劑

9、和和色素PhysicalHazards物理的危危害Decomposition RelatedtoSafety與安全有有關(guān)的腐腐敗FDA水產(chǎn)品HACCP法規(guī)HACCPPlan-CriticalControl PointsandCriticalLimits:CriticalControl Points關(guān)鍵控制制點-A point in processingwherecontrolsneedtobeinplaceCriticalLimits關(guān)鍵限值值-A limit expressedasa value (i.e. timeortemperature) listedata critical cont

10、rolpoint.FDA水產(chǎn)品HACCP法規(guī)Monitoring Procedures監(jiān)測程序序:What WillBeMonitored監(jiān)測什么么？HowWillMonitoring Be Done怎樣監(jiān)測測？FrequencyofMonitoring監(jiān)測頻率率、時間間？Who?誰負責(zé)監(jiān)監(jiān)測？Where?在哪監(jiān)測測？FDA水產(chǎn)品HACCP法規(guī)Corrective Action-Predetermined預(yù)先確定定好的糾糾正措施施:Corrective ActionPlans糾正措施施計劃FDA水產(chǎn)品HACCP法規(guī)Verification驗證-Reassessment重新評估估:VerifyP

11、lansNoLessThan OnceAYear驗證HACCP計劃每年年至少一一次FDA水產(chǎn)品HACCP法規(guī)Verification-ListChanges以下改變變必須驗驗證:RawMaterials or SourcesofRaw Materials原料或原原料來源源Product Formulation產(chǎn)品配方方Processing MethodsorSystems加工方法法或系統(tǒng)統(tǒng)FinishedProduct Distribution成品的配配發(fā)IntendedUseofthe Finished ProductbyConsumers消費者對對成品預(yù)預(yù)期用途途FDA水產(chǎn)品HACCP法規(guī)

12、Verification-VerifyingPerformance驗證的措措施:ConsumerComplaints消費者投投訴CalibratingInstruments(i.e.,thermometers)校準儀器器Testing檢測ReviewingRecords審核記錄錄FDA水產(chǎn)品HACCP法規(guī)Verification-Reassess HazardAnalysis重新評估估危害分分析:ReassessHazardAnalysis-WheneverThereIsa Change一旦有改改變，就就必須重重新進行行危害分分析。FDA水產(chǎn)品HACCP法規(guī)Records-Types文件記錄錄

13、的類型型:HACCPPlan HACCP計劃Monitoring Records監(jiān)測記錄錄Corrective ActionRecords糾偏記錄錄VerificationMeasures驗證記錄錄Sanitation Records衛(wèi)生方面面的記錄錄ImporterVerificationRecords進口商驗驗證記錄錄FDA水產(chǎn)品HACCP法規(guī)Records-RequiredInformation記錄的信信息:Name andLocationofProcessororImporter加工者或或進口商商的名稱稱和地點點Date andTime of Activity Being Record

14、ed被記錄活活動的日日期和時時間SignatureorInitialsofPerson MakingRecord記錄人員員的簽名名Product Identity andCode (when appropriate)產(chǎn)品名稱稱和代碼碼FDA水產(chǎn)品HACCP法規(guī)Records-Retention記錄保留留的時間間:RefrigeratedProducts-1Year冷藏產(chǎn)品品一一年年FrozenProducts-2Years冷凍產(chǎn)品品二二年年FDA水產(chǎn)品HACCP法規(guī)Records-Access:FDAHas AccesstoHACCPRecords andPlansandmay copythe

15、m(for domestic processors)FDAHas AccesstoImporterRecordsFDA有權(quán)檢查查有關(guān)記記錄，并并進行復(fù)復(fù)印。FDA水產(chǎn)品HACCP法規(guī)Plan Contents(復(fù)習(xí))HHACCP計劃的內(nèi)內(nèi)容包括括：Hazards危害CriticalControl Points關(guān)鍵控制制點CriticalLimits關(guān)鍵限值值Corrective Actions糾正措施施Records記錄Verification驗證FDA水產(chǎn)品HACCP法規(guī)Training-Options培訓(xùn)方面面的要求求:TraininginHACCP參加相當當?shù)呐嘤?xùn)訓(xùn)On-TheJob E

16、xperience有一定工工作經(jīng)驗驗“TheSeafoodHACCPAlliance”美國水產(chǎn)產(chǎn)品HACCP聯(lián)盟FDA水產(chǎn)品HACCP法規(guī)Training-Choices:OneTrainedEmployee工作人員員參加培培訓(xùn)Trained Consultant請培訓(xùn)過過的專家家顧問FDA水產(chǎn)品HACCP法規(guī)Training-IndividualShall下列工作作必須要要有一定定資格的的人員來來進行:Develop or Amend theHACCPPlan制訂或修修改HACCP計劃Reassessand/orModify theHACCPPlan重新評估估、修改改HACCP計劃Reass

17、essandModify theHazardAnalysis重新評估估和修改改危害分分析ReviewAllRecords審核所有有的記錄錄FDA水產(chǎn)品HACCP法規(guī)Sanitation-PrerequisitHACCP的前提條條件:PrerequisitetoHACCPMonitoring監(jiān)測Records記錄Corrections糾偏FDA水產(chǎn)品HACCP法規(guī)Sanitation-8 Areas :SSOP至少包括括8個方方面SafetyofWaterThatComesinContact WithFood,FoodContact Surfaces,orUsed to MakeIceCondi

18、tionofFoodContact SurfacesPrevention of Cross ContaminationExclusionofPestsMaintenanceofHand Washing, HandSanitizingandToilet FacilitiesProtection FromContaminantsProperLabeling, Storageand UseofToxicCompoundsControl of Employee HealthConditionsFDA水產(chǎn)品HACCP法規(guī)Sanitation-Monitoring Frequency:Monitoring

19、 Frequencies監(jiān)測頻率率Corrective Measures糾正措施施Records記錄Recordsarerequiredeven ifnoHACCPplan is required即使沒有有HACCP計劃，仍仍然要求求SSOP記錄FDA水產(chǎn)品HACCP法規(guī)Sanitation-Handled Separately: Sanitation controls canbeincludedintheHACCPplan.衛(wèi)生控制制可包含含再HACCP計劃中。Sanitation controls canbehandled outsideofthe HACCP plan.衛(wèi)生控制制可不包包

20、含在HACCP計劃里。IMPORTERREQUIREMENTS對進口商商的要求求CoverageGeneral Provisions一般條款款：AllProcessors對所有加加工者Special RequirementsforImporters對進口商商Special Provisions特殊條款款：SmokedFishRawMolluscanShellfishDefinitions定義Importer進口商-meanseitherthe U.S.ownerorconsignee atthetimeofentryinto theUnitedStates,ortheU.W.agentorre

21、presentativeoftheforeignownerorconsigneeatthe timeofentryinthe UnitedStates, whoisresponsibleforensuringthatgoodsbeingoffered forentryinto theUnitedStates areincompliance withall lawsaffecting theimportationImports 21 CFRPart 123.12ImporterVerification進口商驗驗證ImportFromCountriesWithAnMOU從與FDA簽署相應(yīng)應(yīng)MOU的

22、國家進進口Or或ImplementVerification Procedures實施進口口商驗證證程序-（可由由有資格格的第三三方實施施）Written VerificationProcedures書面的驗驗證程序序Product Specifications to ensurethat theproduct is notinjurioustohealth andnotprocessed underinsanitaryconditions產(chǎn)品說明明書AffirmativeStep確認步驟驟HACCPREGULATION OVERVIEWIMPORTERREQUIREMENTSAffirmati

23、veStep Requirement -Choose at least one:任選其一一On-site visitsbythe importer進口商現(xiàn)現(xiàn)場檢查查Obtainingthe processors HACCP andsanitation records得到加工工者的HACCP計劃和衛(wèi)衛(wèi)生方面面的記錄錄Obtainingthe processors HACCP planand guarantee得到加工工者的HACCP計劃和保保證書End-producttesting andguarantee最終產(chǎn)品品檢測和和保證書書Obtainingacontinuing or lot-by-l

24、otcertification得到連續(xù)續(xù)的或逐逐批的證證書（官方或或第三方方）Otherverificationmethods其他驗證證方法AquacultureProcessing養(yǎng)殖過程程中的藥藥物使用用Hazards associatedwithuseofmedicationsinfeedorbydirectadministrationOfficeofSeafoodAquacultureProcessingDrugsused for:藥物用于于Treatingandpreventingdisease治療和預(yù)預(yù)防疾病病Controllingparasites控制寄生生蟲Controllin

25、greproduction控制繁殖殖Controllinggrowth控制生長長Tranquilizing鎮(zhèn)靜OfficeofSeafoodAquacultureProcessingConditions fordrug approval:Species forwhichthedrugisapproved用藥品種種Approveddosage劑量Approvedrouteoftransmission用藥途徑徑Approvedfrequencyofuse用藥頻率率Approvedindicationsforuse癥狀OfficeofSeafoodAquacultureProcessingDrugs

26、approvedbyFDA:FDA批準的藥藥物ChorionicGonadotropinFormalinsolutionTricainemethanesulfonateOxytetracyclineSulfamerazineSulfadimethoxine/ormetoprimOfficeofSeafoodAquacultureProcessingLabelsofapproveddrugslistthemandatory withdrawaltimes, where applicable.停藥期OfficeofSeafoodAquacultureProcessingTissueresiduet

27、olerances havebeenestablishedforsomedrugs.組織殘留留限量OfficeofSeafoodMolluscanShellfishShellfishAuthorityGovernment authorityresponsibleforenforcementofall regulatoryrequirements associatedwithshellfishMolluscanShellfishShellfishdefinedas:OystersClamsMusselsScallopsMolluscanShellfishRegulatory requiremen

28、tsoftheShellfish Authorityinclude:Growing areaclassificationHarvesting controlProcessing plant andprocedurecontrolProduct labelingStorage,handlingandpackingShipmentcontrolMolluscanShellfishHazards AssociatedWithShellfish:PathogenmicroorganismsNatural Toxinsfrom theharvest waterChemicalcontaminantsfr

29、omtheharvestwaterMolluscanShellfishImportofRawMolluscanShellfishRawmolluscanshellfishcan onlybeimportedintotheUnited Statesfrom countriesthat haveacurrent MemorandumofUnderstanding(MOU)with theUnitedStates Foodand DrugAdministration.MolluscanShellfishImportofMolluscanShellfishCurrent MOUcountriesinc

30、lude:CanadaNewZealandChileSouthKoreaMolluscanShellfishControl of PathogenicMicroorganismsinShellfish fromMOU CountriesForcountries thatcurrently haveaMOUwithFDA, thecontrol strategy forpathogenic microorganisms is implementation of NSSPrequirements to controlthe growing, harvesting, processing, labe

31、ling,andshippingofmolluscanshellfish.MolluscanShellfishControl of PathogenicMicroorganismsinShellfish fromNon-MOUCountriesForcountries thatDONOT currentlyhave aMemorandumofUnderstanding withFDA forimportationofrawmolluscanshellfish, thecontrol strategy forpathogenic microorganisms willbeadequatecook

32、ing.MolluscanShellfishControl of PathogenicMicroorganismsinShellfish fromNon-MOUCountriesCooking or pasteurization processmust reducethetarget organism to anon-detectablelevel.MolluscanShellfishControl of PathogenicMicroorganismsCountriesthatdonotcurrently haveaMemorandum of UnderstandingwiththeUnit

33、ed StatesforrawmolluscanshellfishareNOTpermittedtoimport rawshellfishintotheUnited States.MolluscanShellfishControl of NaturalToxinsCookedmolluscanshellfishispermitted to be imported intothe UnitedStatesonlyiftheprocessor hascontrolled thehazards associatedwithnatural toxinsfrom theharvest water.Mol

34、luscanShellfishControl of NaturalToxinsCooking willnoteliminateorsignificantlyreducethe level of naturaltoxins in shellfishmeats.MolluscanShellfishControl of NaturalToxins2 methodsofControlMonitoring of shellfishmeatsfrom“key” locationsinthegrowingareasORMonitoring of shellfishmeatsonalot-by-lotbasi

35、satthe processingfacility.MolluscanShellfishControl of NaturalToxinsIfnatural toxinsarecontrolledbymonitoring shellfishatthegrowingarea,theControlAuthoritymusthave authoritytoclosetheareafrom harvestingwhenunsafelevels arepresent in shellfishmeats.MolluscanShellfishControl of NaturalToxinsTherearefo

36、urrecognized shellfishpoisoningsyndromes resultingfrom naturaltoxinsproducedbymarine algae. MolluscanShellfishControl of NaturalToxinsParalyticShellfish Poisoning(PSP)NeurotoxicShellfishPoisoning (NSP)DiarrheticShellfishPoisoning (DSP)Amnesic ShellfishPoisoning(ASP)MolluscanShellfishControl of Natur

37、alToxinsActionLevels in MeatsParalyticShellfish Poisoning- 0.8PPM(80ug/100g)saxitoxinequivalent.MolluscanShellfishControl of NaturalToxinsActionLevels in MeatsNeurotoxicShellfishPoisoning -0.8 PPM(20mouseunits/100g)brevetoxin-2equivalent.MolluscanShellfishControl of NaturalToxinsActionLevels in MeatsDiarrheticShellfishPoisoning -0.2