美国HACCP要求英文.docx
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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
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