21CFR117美国食品良好生产规范、危害分析和基于风险的

1、.：.；Vol. 80No. 180Part IIThursday,September 17, 2021Department of Health and Human ServicesFood and Drug Administration21 CFR Parts 1, 11, 16, 106, 110,et al.Current Good Manufacturing Practice, Hazard Analysis, and Risk-BasedPreventive Controls for Human Food; Final RuleVerDate Sep202117:48 Sep 16,

2、 2021Jkt 235001PO 00000Frm 00001Fmt 4717Sfmt 4717E:FRFM17SER2.SGM17SER2 tkelley on DSK3SPTVN1PROD with RULES255908Federal Register / Vol. 80, No. 180 / Thursday, September 17, 2021 / Rules and RegulationsDEPARTMENT OF HEALTH ANDHUMAN SERVICESFood and Drug Administration21 CFR Parts 1, 11, 16, 106, 1

3、10, 114,117, 120, 123, 129, 179, and 211Docket No. FDA2021N0920Current Good Manufacturing Practice,Hazard Analysis, and Risk-BasedPreventive Controls for Human FoodAGENCY: Food and Drug Administration,HHS.ACTION: Final rule.SUMMARY: The Food and DrugAdministration (FDA or we) isamending our regulati

4、on for CurrentGood Manufacturing Practice InManufacturing, Packing, or HoldingHuman Food in two fundamental ways.First, we are modernizing the long-standing current good manufacturingpractice requirements. Second, we areadding requirements for domestic andforeign facilities that are subject to ourre

5、gulation for Registration of FoodFacilities to establish and implementhazard analysis and risk-basedpreventive controls for human food. Wealso are revising certain definitions inour regulation for Registration of FoodFacilities to clarify the scope of theexemption from registrationrequirements provi

6、ded for farms and,in so doing, to clarify which domesticand foreign facilities are subject to therequirements for hazard analysis andrisk-based preventive controls forhuman food. We are taking this actionas part of our announced initiative torevisit the current good manufacturingpractice requirement

7、s since they werelast revised in 1986 and to implementnew statutory provisions in the FDAFood Safety Modernization Act. Therule is intended to build a food safetysystem for the future that makesmodern, science- and risk-basedpreventive controls the norm across allsectors of the food system.DATES: Th

8、is rule is effective November16, 2021, except for the amendment topart 110 in instruction 13, which iseffective September 17, 2021 andparagraph (2) of the definition ofqualified auditor 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

9、) and117.475(c)(13). FDA will publish adocument in the Federal Registerannouncing the effective dates ofparagraph (2) of the definition ofqualified auditor 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). See sect

10、ion LVI for thecompliance dates.FOR FURTHER INFORMATION CONTACT:Jenny Scott, Center for Food Safety andApplied Nutrition (HFS300), Food andDrug Administration, 5100 Paint BranchPkwy., College Park, MD 20740, 2404022166.SUPPLEMENTARY INFORMATION:Table of ContentsExecutive SummaryPurpose and Coverage

11、of the RuleSummary of the Major Provisions of theRuleCosts and BenefitsI. BackgroundA. FDA Food Safety Modernization ActB. Stages in the Rulemaking for the HumanPreventive Controls RuleC. Summary of the Major Provisions ofProposed Human Preventive ControlsRuleD. Draft Risk AssessmentE. Definition of

12、 Retail FoodEstablishmentF. Public CommentsII. Legal AuthorityA. Changes to Current 21 CFR Part 1,Subparts H, I, and JB. Changes to Current 21 CFR Part 110C. Hazard Analysis and Risk-BasedPreventive ControlsD. Comments on Legal AuthorityIII. General Comments on the Proposed RuleIV. Comments on Propo

13、sed Revisions to theDefinitions in the Section 415Registration Regulations (21 CFR Part 1,Subpart H) and the Section 414Recordkeeping Regulations (21 CFR Part1, Subpart J)A. Definitions That Impact a Determinationof Whether an Establishment Is a FarmB. Proposed Revisions to the Definition ofFarmC. P

14、roposed New Definition of HarvestingD. Proposed Revision to the Definition ofHoldingE. Proposed Revision to the Definition ofManufacturing/ProcessingF. Proposed New Definition of Mixed-TypeFacilityG. Proposed Revision to the Definition ofPackingV. Comments on the Organizing Principlesfor How the Sta

15、tus of a Food as a RawAgricultural Commodity or as aProcessed Food Affects the RequirementsApplicable to a Farm Under Sections 415and 418 of the FD&C ActVI. Rulemaking Required by Section 103(c) ofFSMA: On-Farm ActivitiesA. Section 103(c)(1)(C) of FSMAB. Comments on Qualitative RiskAssessment of On-

16、Farm ActivitiesOutside of the Farm DefinitionC. Comments Regarding an Exemption forSmall and Very Small Farm Mixed-TypeFacilities Under Section 421 of the FD&CActVII. Comments on Proposed GeneralRevisions to Current Part 110 (Final Part117)A. Title of Part 117B. Proposed Revisions for Consistency of

17、TermsC. Proposed Additions Regarding AllergenCross-ContactD. Proposed Revisions for ConsistencyWith the Definition of FoodE. Proposed Revisions To AddressGuidance in Current Part 110F. Proposed Editorial ChangesG. General Comments on Current Part 110(Final Part 117)VIII. Subpart A: Comments on Propo

18、sed 117.1Applicability and StatusA. Comments on Proposed 117.1(a)ApplicabilityB. Comments on Proposed 117.1(b)Prohibited ActC. Comments on Proposed 117.1(c)Specific CGMP RequirementsIX. Subpart A: Comments on Proposed 117.3DefinitionsA. RedesignationB. Definitions in Current Part 110 That WeProposed

19、 To DeleteC. Definitions That We Proposed ToEstablish in Part 117D. Comments Asking FDA To EstablishAdditional Definitions or OtherwiseClarify Terms Not Defined in the RuleE. Additional Definitions To Clarify TermsNot Defined in the Proposed RuleX. Subpart A: Comments on Qualifications ofIndividuals

20、 Who Manufacture, Process,Pack, or Hold FoodA. Applicability and Qualifications of AllIndividuals Engaged in Manufacturing,Processing, Packing, or Holding Food(Final 117.4(a), (b), and (d)B. Additional Requirements Applicable toSupervisory Personnel (Final 117.4(c)XI. Subpart A: Comments on Proposed

21、 117.5ExemptionsA. General Comments on the ProposedExemptionsB. Proposed 117.5(a)ExemptionApplicable to a Qualified FacilityC. Proposed 117.5(b) and (c)Exemptions Applicable to Food Subjectto HACCP Requirements for Fish andFishery Products (21 CFR Part 123) or forJuice (21 CFR Part 120)D. Proposed 1

22、17.5(d)ExemptionApplicable to Food Subject to Part 113Thermally Processed Low-Acid FoodsPackaged In Hermetically SealedContainersE. Proposed 117.5(e)ExemptionApplicable to a Facility ThatManufactures, Processes, Packages, orHolds a Dietary SupplementF. Proposed 117.5(f)ExemptionApplicable to Activit

23、ies Subject toStandards for Produce Safety in Section419 of the FD&C ActG. Proposed 117.5(g) and (h)Exemptions Applicable to On-Farm Low-Risk Activity/Food CombinationsConducted by a Small or Very SmallBusinessH. Proposed 117.5(i)Exemption Relatedto Alcoholic BeveragesI. Proposed 117.5(j)ExemptionAp

24、plicable to Facilities Solely Engagedin Storage of Raw AgriculturalCommodities Other Than Fruits andVerDate Sep202117:48 Sep 16, 2021Jkt 235001PO 00000Frm 00002Fmt 4701Sfmt 4700E:FRFM17SER2.SGM17SER2 tkelley on DSK3SPTVN1PROD with RULES2Federal Register / Vol. 80, No. 180 / Thursday, September 17, 2

25、021 / Rules and Regulations55909Vegetables Intended for FurtherDistribution or ProcessingJ. Proposed 117.5(k)ExemptionApplicable to Farms, Fishing Vessels,Activities of Farm Mixed-TypeFacilities Within the Definition ofFarm, the Holding or Transportation ofOne or More Raw AgriculturalCommodities, an

26、d Specified ActivitiesConducted on Specified RawAgricultural CommoditiesK. Comments Requesting AdditionalExemptionsXII. Subpart A: Comments on Proposed 117.7Applicability of Part 117 to aFacility Solely Engaged in the Storage ofUnexposed Packaged FoodXIII. Subpart B: Comments on Proposed 117.10Perso

27、nnelA. Management Responsibility forRequirements Applicable to PersonnelB. Proposed 117.10(a)Disease ControlC. Proposed 117.10(b)CleanlinessXIV. Subpart B: Comments on Proposed 117.20Plant and GroundsA. Proposed 117.20(a)GroundsB. Proposed 117.20(b)PlantConstruction and DesignXV. Subpart B: Comments

28、 on Proposed 117.35Sanitary OperationsA. Proposed 117.35(a)GeneralMaintenanceB. Proposed 117.35(b)Substances Usedin Cleaning and Sanitizing; Storage ofToxic MaterialsC. Proposed 117.35(c)Pest ControlD. Proposed 117.35(d)Sanitation ofFood-Contact SurfacesE. Proposed 117.35(d)(1)Food-ContactSurfaces U

29、sed for Manufacturing/Processing or HoldingF. Proposed 117.35(d)(2)Wet CleaningG. Proposed 117.35(d)(3)Single-ServiceArticlesH. Proposed 117.35(e)Sanitation ofNon-Food-Contact SurfacesI. Proposed 117.35(f)Storage andHandling of Cleaned Portable Equipmentand UtensilsXVI. Subpart B: Comments on Propos

30、ed 117.37Sanitary Facilities andControlsA. Proposed 117.37(a)Water SupplyB. Proposed 117.37(b)PlumbingC. Proposed 117.37(c)Sewage DisposalD. Proposed 117.37(d)Toilet FacilitiesE. Proposed 117.37(e)Hand-WashingFacilitiesXVII. Subpart B: Comments on Proposed 117.40Equipment and UtensilsA. Proposed 117

31、.40(a)Design,Construction, Use, Installation, andMaintenance of Equipment and UtensilsB. Proposed 117.40(b)Seams on Food-Contact SurfacesC. Proposed 117.40(c)Construction ofEquipmentD. Proposed 117.40(d)Holding,Conveying, and Manufacturing SystemsE. Proposed 117.40(e)Freezer and ColdStorage Compartm

32、entsF. Proposed 117.40(f)Accurate andPrecise Instruments and ControlsG. Proposed 117.40(g)Compressed Airor Other GasesXVIII. Subpart B: Comments on Proposed 117.80(a)General Processes andControlsA. Proposed 117.80(a)(1)AdequateSanitation PrinciplesB. Proposed 117.80(a)(2)QualityControl OperationsC.

33、Proposed 117.80(a)(3)Supervision ofOverall SanitationD. Proposed 117.80(a)(4)ProductionProceduresE. Proposed 117.80(a)(5)Chemical,Microbial, or Extraneous-MaterialTesting ProceduresF. Proposed 117.80(a)(6)ContaminatedFoodXIX. Subpart B: Comments on Proposed 117.80(b)Processes and Controls forRaw Mat

34、erials and Other IngredientsA. Proposed 117.80(b)(1)Inspection,Segregation and Handling of RawMaterials and Other IngredientsB. Proposed 117.80(b)(2)Levels ofMicroorganisms in Raw Materials andOther IngredientsC. Proposed 117.80(b)(3)Natural Toxinsin Raw Materials and Other IngredientsD. Proposed 11

35、7.80(b)(4)Pests,Undesirable Microorganisms andExtraneous Materials in Raw Materialsand Other IngredientsE. Proposed 117.80(b)(5)Holding RawMaterials, Other Ingredients, and Reworkin BulkF. Proposed 117.80(b)(7)Liquid or DryRaw Materials and Other IngredientsG. Proposed 117.80(b)(8)Raw Materialsand O

36、ther Ingredients That Are FoodAllergensXX. Subpart B: Comments on Proposed 117.80(c)Manufacturing OperationsA. Proposed 117.80(c)(1)Condition ofEquipment, Utensils, and Finished FoodContainersB. Proposed 117.80(c)(2)Conditions andControls for Food Manufacturing,Processing, Packing, and HoldingC. Pro

37、posed 117.80(c)(3)Food That CanSupport the Rapid Growth ofUndesirable MicroorganismsD. Proposed 117.80(c)(4)Measures ToDestroy or Prevent the Growth ofUndesirable MicroorganismsE. Proposed 117.80(c)(5)Work-in-Process and ReworkF. Proposed 117.80(c)(6)Finished FoodG. Proposed 117.80(c)(7)Equipment,Co

38、ntainers, and UtensilsH. Proposed 117.80(c)(8)Metal or OtherExtraneous MaterialI. Proposed 117.80(c)(9)Disposal ofAdulterated Food, Raw Materials, andOther IngredientsJ. Proposed 117.80(c)(10)PerformingManufacturing StepsK. Proposed 117.80(c)(11)HeatBlanching and Growth andContamination by Thermophi

39、licMicroorganisms During ManufacturingOperationsL. Proposed 117.80(c)(12)Batters,Breading, Sauces, Gravies, Dressings,and Other Similar PreparationsM. Proposed 117.80(c)(13)Filling,Assembling, Packaging and OtherOperationsN. Proposed 117.80(c)(14)Food ThatRelies on the Control of Water Activityfor P

40、reventing the Growth of UndesirableMicroorganismsO. Proposed 117.80(c)(15)Food ThatRelies on the Control of pH forPreventing the Growth of UndesirableMicroorganismsP. Proposed 117.80(c)(16)Requirementsfor Ice Used in Contact With FoodQ. Proposed Deletion of Current 110.80(b)(17)Food-ManufacturingAre

41、as and EquipmentXXI. Subpart B: Comments on Proposed 117.93Warehousing and DistributionXXII. Subpart B: Comments on Proposed 117.110Natural or UnavoidableDefects in Food for Human Use ThatPresent No Health HazardXXIII. Subpart C: Comments on OverallFramework for Hazard Analysis andRisk-Based Prevent

42、ive ControlsXXIV. Subpart C: Comments on Proposed 117.126Food Safety PlanA. Proposed 117.126(a)(1)Requirementfor a Food Safety PlanB. Proposed 117.126(a)(2)Preparation ofthe Food Safety Plan by a PreventiveControls Qualified IndividualC. Proposed 117.126(b)Contents of aFood Safety PlanD. Proposed 11

43、7.126(c)RecordsE. Comments on Potential Requirementsfor Submission of a Facility Profile toFDAXXV. Subpart C: Comments on Proposed 117.130Hazard AnalysisA. Proposed 117.130(a)Requirement fora Written Hazard AnalysisB. Proposed 117.130(b)HazardIdentificationC. Proposed 117.130(c)Evaluation ofWhether

44、a Hazard Requires a PreventiveControlXXVI. Subpart C: Comments on Proposed 117.Preventive ControlsA. Proposed 117.(a)Requirement ToIdentify and Implement PreventiveControlsB. Proposed 117.(b)Requirement forWritten Preventive ControlsC. Proposed 117.(c)(1)ProcessControlsD. Proposed 117.(c)(2)FoodAlle

45、rgen ControlsE. Proposed 117.(c)(3)SanitationControlsF. Proposed 117.(c)(4)Supply-ChainControlsG. Proposed 117.(c)(5)Recall PlanH. Proposed 117.(c)(6)OtherControlsXXVII. Subpart C: Circumstances in Whichthe Owner, Operator, or Agent in Chargeof a Manufacturing/Processing Facility IsNot Required To I

46、mplement a PreventiveControl (Final 117. and 117.)XXVIII. Subpart C: Comments on ProposedRequirements for a Recall Plan (Final 117.)A. Proposed 117.(a)Requirement fora Written Recall Plan (Final 117.(a)B. Proposed 117.(b)Procedures ThatDescribe the Steps To Be Taken, andAssign Responsibility for Tak

47、ing ThoseSteps (Final 117.(b)VerDate Sep202117:48 Sep 16, 2021Jkt 235001PO 00000Frm 00003Fmt 4701Sfmt 4700E:FRFM17SER2.SGM17SER2 tkelley on DSK3SPTVN1PROD with RULES255910Federal Register / Vol. 80, No. 180 / Thursday, September 17, 2021 / Rules and RegulationsXXIX. Comments on Proposed 117.140Preve

48、ntive Control ManagementComponentsA. Proposed 117.140(a)FlexibleRequirements for Monitoring, CorrectiveActions and Corrections, andVerificationB. Proposed 117.140(b)Applicability ofPreventive Control ManagementComponents to the Supply-ChainProgramC. Proposed 117.140(c)Recall Plan isNot Subject to Pr

49、eventive ControlManagement ComponentsXXX. Subpart C: Comments on Proposed 117.145MonitoringA. Our Tentative Conclusion To RequireMonitoring of the Performance ofPreventive ControlsB. Proposed 117.145(a)Flexibility inRequirements for MonitoringC. Proposed 117.145(b)RecordsXXXI. Subpart C: Comments on

50、 Proposed 117.150Corrective Actions andCorrectionsA. Proposed 117.150(a)(1)RequirementTo Establish and Implement CorrectiveAction ProceduresB. Proposed 117.150(a)(2)Content ofCorrective Action ProceduresC. Proposed 117.150(b)CorrectiveAction in the Event of an UnanticipatedProblemD. Proposed 117.150

51、(c)CorrectionsE. Proposed 117.150(d)RecordsXXXII. Subpart C: Comments on Proposed 117.155VerificationA. Flexibility in Requirements forVerificationB. Proposed 117.155(a)VerificationActivitiesC. Proposed 117.155(b)Documentationof Verification ActivitiesD. Comments on Potential RequirementsRegarding C

52、omplaintsXXXIII. Subpart C: Comments on Proposed 117.160ValidationA. Flexibility in the Requirements ToValidate Preventive ControlsB. Proposed 117.160(b)(1)WhenValidation Must Be Performed and Roleof the Preventive Controls QualifiedIndividual in ValidationC. Proposed 117.160(b)(2)WhatValidation Mus

53、t IncludeD. Proposed 117.160(b)(3)PreventiveControls for Which Validation Is NotRequiredXXXIV. Subpart C: Comments on Proposed 117.165Verification ofImplementation and EffectivenessA. Flexibility in the Requirements ToConduct Activities To VerifyImplementation and EffectivenessB. Proposed 117.165(a)

54、(1)CalibrationC. Comments Directed to ProposedRequirements for Both Product Testing(Proposed 117.165(a)(2) and (b)(2) andEnvironmental Monitoring (Proposed 117.165(a)(3) and (b)(3)D. Proposed 117.165(a)(2)ProductTestingE. Proposed 117.165(a)(3)Environmental MonitoringF. Proposed 117.165(a)(4)Review

55、ofRecordsG. Proposed 117.165(b)WrittenProceduresXXXV. Subpart C: Comments on Proposed 117.170ReanalysisA. Proposed 117.170(a)CircumstancesRequiring ReanalysisB. Proposed 117.170(b)Timeframe ToComplete ReanalysisC. Proposed 117.170(c)Requirement ToRevise the Written Food Safety Plan orDocument Why Re

56、visions Are NotNeededD. Proposed 117.170(d)Requirement forOversight of Reanalysis by a PreventiveControls Qualified IndividualE. Proposed 117.170(e)Reanalysis onthe Initiative of FDAXXXVI. Subpart C: Comments on Proposed 117.180Requirements Applicable to aPreventive Controls Qualified Individualand

57、a Qualified AuditorA. Proposed 117.180(a) and (b)What aPreventive Controls Qualified Individualor Qualified Auditor Must Do or OverseeB. Proposed 117.180(c)QualificationRequirementsC. Proposed 117.180(d)RecordsXXXVII. Subpart C: Comments on Proposed 117.190Implementation RecordsA. Proposed 117.190(a

58、)List of RequiredRecordsB. Proposed 117.190(b)Applicability ofSubpart FXXXVIII. Subpart D: Comments on Proposed 117.201Modified Requirements ThatApply to a Qualified FacilityA. Comments on Submission of aCertification StatementB. General Comments on ModifiedRequirements That Apply to a QualifiedFaci

59、lityC. Proposed 117.201(a)DocumentationTo Be SubmittedD. Proposed 117.201(b)Procedure forSubmissionE. Proposed 117.201(c)Frequency ofDetermination and SubmissionF. Proposed 117.201(d)Notification toConsumers (Final 117.201(e)G. Proposed 117.201(e)Records (Final 117.201(f)XXXIX. Subpart D: Comments o

60、n Proposed 117.206Modified Requirements ThatApply to a Facility Solely Engaged in theStorage of Unexposed Packaged FoodA. Proposed 117.206(a)ModifiedRequirements for UnexposedRefrigerated Packaged Food ThatRequires Time/Temperature ControlsB. Proposed 117.206(b)RecordsXL. Subpart E: Comments on Prop