美国HACCP要求英文Word文件下载.docx
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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.
(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.
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.
Part110ofthischapterappliesindeterminingwhetherthefacilities,methods,practices,andcontrolsusedtoprocessjuicearesafe,andwhetherthefoodhasbeenprocessedundersanitaryconditions.
(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;
(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.
(a)Eachprocessorshalldevelop,orhavedevelopedforit,awrittenhazardanalysistodeterminewhethertherearefoodhazardsthatarereasonablylikelytooccurforeachtypeofjuiceprocessedbythatprocessorandtoidentifycontrolmeasuresthattheprocessorcanapplytocontrolthosehazards.Thewrittenhazardanalysisshallconsistofatleastthefollowing:
(1)Identificationoffoodhazards;
(2)Anevaluationofeachfoodhazardidentifiedtodetermineifthehazardisreasonablylikelytooccurandthus,constitutesafoodhazardthatmustbeaddressedintheHACCPplan.Afoodhazardthatisreasonablylikelytooccurisoneforwhichaprudentprocessorwouldestablishcontrolsbecauseexperience,illnessdata,scientificreports,orotherinformationprovideabasistoconcludethatthereisareasonablepossibilitythat,intheabsenceofthosecontrols,thefoodhazardwilloccurintheparticulartypeofproductbeingprocessed.Thisevaluationshallincludeanassessmentoftheseverityoftheillness