美国HACCP要求英文.docx

美国HACCP要求英文.docx

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美国HACCP要求英文

Title21:

FoodandDrugs

PART120—HAZARDANALYSISANDCRITICALCONTROLPOINT（HACCP）SYSTEMS

SectionContents

SubpartA—GeneralProvisions

§ 120.1   Applicability.

§ 120.3   Definitions.

§ 120.5   Currentgoodmanufacturingpractice.

§ 120.6   Sanitationstandardoperatingprocedures.

§ 120.7   Hazardanalysis.

§ 120.8   HazardAnalysisandCriticalControlPoint（HACCP）plan.

§ 120.9   Legalbasis.

§ 120.10   Correctiveactions.§ 120.11   Verificationandvalidation.

§ 120.12   Records.

§ 120.13   Training.

§ 120.14   Applicationofrequirementstoimportedproducts.

SubpartB—PathogenReduction

§ 120.20   General.

§ 120.24   Processcontrols.

§ 120.25   Processverificationforcertainprocessors.

Authority:

  21U.S.C.321,342,343,346,348,371,374,379e,381,393;42U.S.C.241,242l,264.

Source:

  66FR6197,Jan.19,2001,unlessotherwisenoted.

SubpartA—GeneralProvisions

§ 120.1   Applicability.

（a）Anyjuicesoldassuchorusedasaningredientinbeveragesshallbeprocessedinaccordancewiththerequirementsofthispart.Juicemeanstheaqueousliquidexpressedorextractedfromoneormorefruitsorvegetables,pureesoftheedibleportionsofoneormorefruitsorvegetables,oranyconcentratesofsuchliquidorpuree.Therequirementsofthispartshallapplytoanyjuiceregardlessofwhetherthejuice,oranyofitsingredients,isorhasbeenshippedininterstatecommerce（asdefinedinsection201（b）oftheFederalFood,Drug,andCosmeticAct,21U.S.C.321（b））.Rawagriculturalingredientsofjuicearenotsubjecttotherequirementsofthispart.Processorsshouldapplyexistingagencyguidancetominimizemicrobialfoodsafetyhazardsforfreshfruitsandvegetablesinhandlingrawagriculturalproducts.

（b）TheregulationsinthispartshallbeeffectiveJanuary22,2002.However,byitsterms,thispartisnotbindingonsmallandverysmallbusinessesuntilthedateslistedinparagraphs（b）

（1）and（b）

（2）ofthissection.

（1）Forsmallbusinessesemployingfewerthan500personstheregulationsinthispartarebindingonJanuary21,2003.

（2）Forverysmallbusinessesthathaveeithertotalannualsalesoflessthan$500,000,oriftheirtotalannualsalesaregreaterthan$500,000buttheirtotalfoodsalesarelessthan$50,000;orthepersonclaimingthisexemptionemployedfewerthananaverageof100full-timeequivalentemployeesandfewerthan100,000unitsofjuiceweresoldintheUnitedStates,theregulationsarebindingonJanuary20,2004.

§ 120.3   Definitions.

Thedefinitionsoftermsinsection201oftheFederalFood,Drug,andCosmeticAct,§101.9（j）（18）（vi）,andpart110ofthischapterareapplicabletosuchtermswhenusedinthispart,exceptwhereredefinedinthispart.Thefollowingdefinitionsshallalsoapply:

（a）Cleanedmeanswashedwithwaterofadequatesanitaryquality.

（b）Controlmeanstoprevent,eliminate,orreduce.

（c）Controlmeasuremeansanyactionoractivitytoprevent,reducetoacceptablelevels,oreliminateahazard.

（d）Criticalcontrolpointmeansapoint,step,orprocedureinafoodprocessatwhichacontrolmeasurecanbeappliedandatwhichcontrolisessentialtoreduceanidentifiedfoodhazardtoanacceptablelevel.

（e）Criticallimitmeansthemaximumorminimumvaluetowhichaphysical,biological,orchemicalparametermustbecontrolledatacriticalcontrolpointtoprevent,eliminate,orreducetoanacceptableleveltheoccurrenceoftheidentifiedfoodhazard.

（f）Culledmeansseparationofdamagedfruitfromundamagedfruit.Forprocessorsofcitrusjuicesusingtreatmentstofruitsurfacestocomplywith§120.24,culledmeansundamaged,tree-pickedfruitthatisU.S.DepartmentofAgriculturechoiceorhigherquality.

（g）Foodhazardmeansanybiological,chemical,orphysicalagentthatisreasonablylikelytocauseillnessorinjuryintheabsenceofitscontrol.

（h）ImportermeanseithertheU.S.ownerorconsigneeatthetimeofentryofafoodproductintotheUnitedStates,ortheU.S.agentorrepresentativeoftheforeignownerorconsigneeatthetimeofentryintotheUnitedStates.TheimporterisresponsibleforensuringthatgoodsbeingofferedforentryintotheUnitedStatesareincompliancewithallapplicablelaws.Forthepurposesofthisdefinition,theimporterisordinarilynotthecustomhousebroker,thefreightforwarder,thecarrier,orthesteamshiprepresentative.

（i）Monitormeanstoconductaplannedsequenceofobservationsormeasurementstoassesswhetheraprocess,point,orprocedureisundercontrolandtoproduceanaccuraterecordforuseinverification.

（j）

（1）Processingmeansactivitiesthataredirectlyrelatedtotheproductionofjuiceproducts.

（2）Forpurposesofthispart,processingdoesnotinclude:

（i）Harvesting,picking,ortransportingrawagriculturalingredientsofjuiceproducts,withoutotherwiseengaginginprocessing;and

（ii）Theoperationofaretailestablishment.

（k）Processormeansanypersonengagedincommercial,custom,orinstitutionalprocessingofjuiceproducts,eitherintheUnitedStatesorinaforeigncountry,includinganypersonengagedintheprocessingofjuiceproductsthatareintendedforuseinmarketorconsumertests.

（l）Retailestablishmentisanoperationthatprovidesjuicedirectlytotheconsumersanddoesnotincludeanestablishmentthatsellsordistributesjuicetootherbusinessentitiesaswellasdirectlytoconsumers.“Provides”includesstoring,preparing,packaging,serving,andvending.

（m）Shallisusedtostatemandatoryrequirements.

（n）Shelf-stableproductmeansaproductthatishermeticallysealedand,whenstoredatroomtemperature,shouldnotdemonstrateanymicrobialgrowth.

（o）Shouldisusedtostaterecommendedoradvisoryproceduresortoidentifyrecommendedequipment.

（p）ValidationmeansthatelementofverificationfocusedoncollectingandevaluatingscientificandtechnicalinformationtodeterminewhethertheHACCPplan,whenproperlyimplemented,willeffectivelycontroltheidentifiedfoodhazards.

（q）Verificationmeansthoseactivities,otherthanmonitoring,thatestablishthevalidityoftheHACCPplanandthatthesystemisoperatingaccordingtotheplan.

§ 120.5   Currentgoodmanufacturingpractice.

Part110ofthischapterappliesindeterminingwhetherthefacilities,methods,practices,andcontrolsusedtoprocessjuicearesafe,andwhetherthefoodhasbeenprocessedundersanitaryconditions.

§ 120.6   Sanitationstandardoperatingprocedures.

（a）Sanitationcontrols.Eachprocessorshallhaveandimplementasanitationstandardoperatingprocedure（SSOP）thataddressessanitationconditionsandpracticesbefore,during,andafterprocessing.TheSSOPshalladdress:

（1）Safetyofthewaterthatcomesintocontactwithfoodorfoodcontactsurfacesorthatisusedinthemanufactureofice;

（2）Conditionandcleanlinessoffoodcontactsurfaces,includingutensils,gloves,andoutergarments;

（3）Preventionofcrosscontaminationfrominsanitaryobjectstofood,foodpackagingmaterial,andotherfoodcontactsurfaces,includingutensils,gloves,andoutergarments,andfromrawproducttoprocessedproduct;

（4）Maintenanceofhandwashing,handsanitizing,andtoiletfacilities;

（5）Protectionoffood,foodpackagingmaterial,andfoodcontactsurfacesfromadulterationwithlubricants,fuel,pesticides,cleaningcompounds,sanitizingagents,condensate,andotherchemical,physical,andbiologicalcontaminants;

（6）Properlabeling,storage,anduseoftoxiccompounds;

（7）Controlofemployeehealthconditionsthatcouldresultinthemicrobiologicalcontaminationoffood,foodpackagingmaterials,andfoodcontactsurfaces;and

（8）Exclusionofpestsfromthefoodplant.

（b）Monitoring.Theprocessorshallmonitortheconditionsandpracticesduringprocessingwithsufficientfrequencytoensure,ataminimum,conformancewiththoseconditionsandpracticesspecifiedinpart110ofthischapterthatareappropriatebothtotheplantandtothefoodbeingprocessed.Eachprocessorshallcorrect,inatimelymanner,thoseconditionsandpracticesthatarenotmet.

（c）Records.EachprocessorshallmaintainSSOPrecordsthat,ataminimum,documentthemonitoringandcorrectionsprescribedbyparagraph（b）ofthissection.Theserecordsaresubjecttotherecordkeepingrequirementsof§120.12.

（d）RelationshiptoHazardAnalysisandCriticalControlPoint（HACCP）plan.SanitationstandardoperatingprocedurecontrolsmaybeincludedintheHACCPplanrequiredunder§120.8（b）.However,totheextentthattheyareimplementedinaccordancewiththissection,theyneednotbeincludedintheHACCPplan.

§ 120.7   Hazardanalysis.

（a）Eachprocessorshalldevelop,orhavedevelopedforit,awrittenhazardanalysistodeterminewhethertherearefoodhazardsthatarereasonablylikelytooccurforeachtypeofjuiceprocessedbythatprocessorandtoidentifycontrolmeasuresthattheprocessorcanapplytocontrolthosehazards.Thewrittenhazardanalysisshallconsistofatleastthefollowing:

（1）Identificationoffoodhazards;

（2）Anevaluationofeachfoodhazardidentifiedtodetermineifthehazardisreasonablylikelytooccurandthus,constitutesafoodhazardthatmustbeaddressedintheHACCPplan.Afoodhazardthatisreasonablylikelytooccurisoneforwhichaprudentprocessorwouldestablishcontrolsbecauseexperience,illnessdata,scientificreports,orotherinformationprovideabasistoconcludethatthereisareasonablepossibilitythat,intheabsenceofthosecontrols,thefoodhazardwilloccurintheparticulartypeofproductbeingprocessed.Thisevaluationshallincludeanassessmentoftheseverityoftheillness