21CFR117美国食品良好生产规范、危害分析和基于风险的

Vol.80No.180PartIIThursday,September17,2015DepartmentofHealthandHumanServicesFoodandDrugAdministration21CFRParts1,11,16,106,110,etal.CurrentGoodManufacturingPractice,HazardAnalysis,andRisk-BasedPreventiveControlsforHumanFood;FinalRuleVerDateSep11201417:48Sep16,2015Jkt235001PO00000Frm00001Fmt4717Sfmt4717E:\FR\FM\17SER2.SGM17SER2tkelleyonDSK3SPTVN1PRODwithRULES255908FederalRegister/Vol.80,No.180/Thursday,September17,2015/RulesandRegulationsDEPARTMENTOFHEALTHANDHUMANSERVICESFoodandDrugAdministration21CFRParts1,11,16,106,110,114,117,120,123,129,179,and211[DocketNo.FDA–2011–N–0920]CurrentGoodManufacturingPractice,HazardAnalysis,andRisk-BasedPreventiveControlsforHumanFoodAGENCY:FoodandDrugAdministration,HHS.ACTION:Finalrule.SUMMARY:TheFoodandDrugAdministration(FDAorwe)isamendingourregulationforCurrentGoodManufacturingPracticeInManufacturing,Packing,orHoldingHumanFoodintwofundamentalways.First,wearemodernizingthelong-standingcurrentgoodmanufacturingpracticerequirements.Second,weareaddingrequirementsfordomesticandforeignfacilitiesthataresubjecttoourregulationforRegistrationofFoodFacilitiestoestablishandimplementhazardanalysisandrisk-basedpreventivecontrolsforhumanfood.WealsoarerevisingcertaindefinitionsinourregulationforRegistrationofFoodFacilitiestoclarifythescopeoftheexemptionfromregistrationrequirementsprovidedfor‘‘farms’’and,insodoing,toclarifywhichdomesticandforeignfacilitiesaresubjecttotherequirementsforhazardanalysisandrisk-basedpreventivecontrolsforhumanfood.Wearetakingthisactionaspartofourannouncedinitiativetorevisitthecurrentgoodmanufacturingpracticerequirementssincetheywerelastrevisedin1986andtoimplementnewstatutoryprovisionsintheFDAFoodSafetyModernizationAct.Theruleisintendedtobuildafoodsafetysystemforthefuturethatmakesmodern,science-andrisk-basedpreventivecontrolsthenormacrossallsectorsofthefoodsystem.DATES:ThisruleiseffectiveNovember16,2015,exceptfortheamendmenttopart110ininstruction13,whichiseffectiveSeptember17,2018andparagraph(2)ofthedefinitionof‘‘qualifiedauditor’’in§117.3,and§§117.5(k)(2),117.8,117.405(a)(2),117.405(c),117.410(d)(2)(ii),117.430(d),117.435(d),117.475(c)(2)and117.475(c)(13).FDAwillpublishadocumentintheFederalRegisterannouncingtheeffectivedatesofparagraph(2)ofthedefinitionof‘‘qualifiedauditor’’in§117.3,and§§117.5(k)(2),117.8,117.405(a)(2),117.405(c),117.410(d)(2)(ii),117.430(d),117.435(d),117.475(c)(2),and117.475(c)(13).SeesectionLVIforthecompliancedates.FORFURTHERINFORMATIONCONTACT:JennyScott,CenterforFoodSafetyandAppliedNutrition(HFS–300),FoodandDrugAdministration,5100PaintBranchPkwy.,CollegePark,MD20740,240–402–2166.SUPPLEMENTARYINFORMATION:TableofContentsExecutiveSummaryPurposeandCoverageoftheRuleSummaryoftheMajorProvisionsoftheRuleCostsandBenefitsI.BackgroundA.FDAFoodSafetyModernizationActB.StagesintheRulemakingfortheHumanPreventiveControlsRuleC.SummaryoftheMajorProvisionsofProposedHumanPreventiveControlsRuleD.DraftRiskAssessmentE.Definitionof‘‘RetailFoodEstablishment’’F.PublicCommentsII.LegalAuthorityA.ChangestoCurrent21CFRPart1,SubpartsH,I,andJB.ChangestoCurrent21CFRPart110C.HazardAnalysisandRisk-BasedPreventiveControlsD.CommentsonLegalAuthorityIII.GeneralCommentsontheProposedRuleIV.CommentsonProposedRevisionstotheDefinitionsintheSection415RegistrationRegulations(21CFRPart1,SubpartH)andtheSection414RecordkeepingRegulations(21CFRPart1,SubpartJ)A.DefinitionsThatImpactaDeterminationofWhetheranEstablishmentIsa‘‘Farm’’B.ProposedRevisionstotheDefinitionofFarmC.ProposedNewDefinitionofHarvestingD.ProposedRevisiontotheDefinitionofHoldingE.ProposedRevisiontotheDefinitionofManufacturing/ProcessingF.ProposedNewDefinitionofMixed-TypeFacilityG.ProposedRevisiontotheDefinitionofPackingV.CommentsontheOrganizingPrinciplesforHowtheStatusofaFoodasaRawAgriculturalCommodityorasaProcessedFoodAffectstheRequirementsApplicabletoaFarmUnderSections415and418oftheFD&CActVI.RulemakingRequiredbySection103(c)ofFSMA:On-FarmActivitiesA.Section103(c)(1)(C)ofFSMAB.CommentsonQualitativeRiskAssessmentofOn-FarmActivitiesOutsideoftheFarmDefinitionC.CommentsRegardinganExemptionforSmallandVerySmallFarmMixed-TypeFacilitiesUnderSection421oftheFD&CActVII.CommentsonProposedGeneralRevisionstoCurrentPart110(FinalPart117)A.TitleofPart117B.ProposedRevisionsforConsistencyofTermsC.ProposedAdditionsRegardingAllergenCross-ContactD.ProposedRevisionsforConsistencyWiththeDefinitionof‘‘Food’’E.ProposedRevisionsToAddressGuidanceinCurrentPart110F.ProposedEditorialChangesG.GeneralCommentsonCurrentPart110(FinalPart117)VIII.SubpartA:CommentsonProposed§117.1—ApplicabilityandStatusA.CommentsonProposed§117.1(a)—ApplicabilityB.CommentsonProposed§117.1(b)—ProhibitedActC.CommentsonProposed§117.1(c)—SpecificCGMPRequirementsIX.SubpartA:CommentsonProposed§117.3—DefinitionsA.RedesignationB.DefinitionsinCurrentPart110ThatWeProposedToDeleteC.DefinitionsThatWeProposedToEstablishinPart117D.CommentsAskingFDAToEstablishAdditionalDefinitionsorOtherwiseClarifyTermsNotDefinedintheRuleE.AdditionalDefinitionsToClarifyTermsNotDefinedintheProposedRuleX.Subpa