FDA风险分析指南-HACCP-Hazards-and-Controls-Guidance-Firs

15-9-17GuidanceDocuments&RegulatoryInformationbyTopicGuidanceforIndustry:JuiceHACCPHazardsandControlsGuidanceFirstEdition;FinalG…:JuiceHACCPHazardsandControlsGuidanceFirstEdition;FinalGuidanceContainsNonbindingRecommendationsMarch3,2004Commentsandsuggestionsregardingthisdocumentmaybesubmittedatanytime.SubmitcommentstoDocketsManagementBranch(HFA-305),FoodandDrugAdministration,5630FishersLane,rm.1061,Rockville,MD20852.AllcommentsshouldbeidentifiedwiththeDocketNumber02D-0333.Forquestionsregardingthisdocument,contactMichaelE.KashtockattheCenterforFoodSafetyandAppliedNutrition(CFSAN)at(Tel)301-436-2022(Updatedphone:240-402-2022),(Fax)301-436-2651,ore-mailmkashtoc@.fda.hhs.gov.Additionalcopiesareavailablefrom:OfficeofPlantandDairyFoodsCenterforFoodSafetyandAppliedNutritionFoodandDrugAdministration;5100PaintBranchParkwayCollegePark,MD20740(CFSAN)February2004ContainsNonbindingRecommendationsGuidanceforIndustryJuiceHACCPHazardsandControlsGuidanceFirstEditionThisguidancerepresentstheFoodandDrugAdministration's(FDA's)currentthinkingonthistopic.ItdoesnotcreateorconferanyrightsfororonanypersonanddoesnotoperatetobindFDAorthepublic.Youcanuseanalternativeapproachiftheapproachsatisfiestherequirementsoftheapplicablestatutesandregulations.Ifyouwanttodiscussanalternativeapproach,contacttheFDAstaffresponsibleforimplementingthisguidance.IfyoucannotidentifytheappropriateFDAstaff,calltheappropriatenumberlistedonthetitlepageofthisguidance.HighlightsoftheJuiceHACCPRegulationBothinterstateandintrastatejuiceprocessorsmustevaluatetheirprocessingoperationsusingHACCPprinciples.EffectivedatesfortheregulationareJanuary20,2002,January21,2003,orJanuary22,2004,dependinguponthesizeofyourbusiness.TheregulationdoesnotpreempttheexistingrequirementstofollowthecurrentGoodManufacturingPractice(CGMP)regulationsforyourjuiceprocessingoperations.TheHACCPplanandotherrecordsofyoursanitationstandardoperatingprocedures(SSOPs)andHACCPoperationsmustbeavailableforofficialinspectionandcopying.Employeesinvolvedindeveloping,orincertainaspectsofimplementing,aHACCPplan,mustbetrainedinHACCPprinciples.The5-logpathogenreductionmustbeaccomplishedforthemicrobeyouidentifyasthepertinentmicroorganism,whichisthemostresistantmicroorganismofpublichealthsignificancethatislikelytooccurinthejuice,e.g.,E.coliO157:H7,takeplaceinonefacilityjustpriortoorafterpackaging,andbeapplieddirectlytothejuice,exceptforcitrusjuices.Fruitsurfacetreatmentsmaybeusedtoaccomplishthe5-logreductionforcitrusfruits,butcleanedandundamagedtree-pickedfruitmustbeusedandtheeffectivenessofthetreatmentmustbeverifiedbyregularlytestingyourproductforgenericE.coli.ShelfstablejuicesmadeusingasinglethermalprocessingstepandjuiceconcentratesmadeusingathermalconcentrationprocessthatincludesalloftheingredientsareexemptfromtherequirementtoincludecontrolmeasuresinyourHACCPplantoachievethe5-logpathogen(1)(2)15-9-17GuidanceDocuments&RegulatoryInformationbyTopicGuidanceforIndustry:JuiceHACCPHazardsandControlsGuidanceFirstEdition;FinalG…(g)thatrequiresawarningstatementonpackagedfruitandvegetablejuiceproductsthathavenotbeenprocessedtoprevent,reduce,oreliminatepathogenicmicroorganismsthatmaybepresent,andwithanyapplicablestateregulations.TableofContentsI.IntroductionA.StatusB.PurposeC.ScopeandLimitationsII.TermsandDefinitionsIII.OverviewoftheJuiceHACCPRegulationA.ComplianceRequiredforAllJuiceProcessors1.0IntrastateandInterstateFirms2.0EffectiveDates-VerySmallBusinesses,SmallBusinesses,AllOthers3.0JuiceImporters4.0IfYouProcessaNon-JuiceBeverageswithaJuiceIngredientB.SomeKeyRequirementsoftheJuiceHACCPRegulation1.0WarningLabelStatementVersusHACCPSystem2.0SpecializedTraininginHACCPPrincipalsRequired3.0TrainedEmployeeorConsultantAcceptable4.0RecordKeepingandElectronicRecords4.1OfficialReviewofRecordsC.Part110(CGMPs)ApplicabletoFirmsSubjecttoJuiceHACCPRegulationD.ExemptionsandItemsNotSubjecttotheRegulation1.0RetailBusinesses2.0Non-BeverageFoodswithJuiceIngredient(afruit-flavoredcandy)3.0ProcessorsofIngredientsFromFruitOthe