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FDA Updates on FSMA Implementation Dr. Marla Keller, Center for Veterinary Medicine Food and Drug Administration Distillers Grain Technology Conference Des Moines, Iowa - May 17, 2018 www.fda.gov

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Page 1: FDA Updates on FSMA Implementation · 2018-05-21 · CGMP Inspections (FY18): What to Expect • Only inspections in FY18 will be for compliance with CGMPs for “large” and “small”

FDAUpdatesonFSMAImplementation

Dr.MarlaKeller,CenterforVeterinaryMedicineFoodandDrugAdministration

DistillersGrainTechnologyConferenceDesMoines,Iowa-May17,2018

www.fda.gov

Page 2: FDA Updates on FSMA Implementation · 2018-05-21 · CGMP Inspections (FY18): What to Expect • Only inspections in FY18 will be for compliance with CGMPs for “large” and “small”

2

FSMABackground

•  AppliestoallfacilitiesthatarerequiredtoregisterwithFDAbecausetheymanufacture,process,pack,orholdfoodforconsumptionintheU.S.

•  “Food”and“Animalfood”includearticlesusedforcomponentsoffood,suchasrawmaterialsorotheringredients–  TheFD&CAct§201(f)–  21CFR507.3definitions

•  DraftGuidanceforIndustry:QuestionsandAnswersRegardingFoodFacilityRegistration(SeventhEdition)– www.fda.gov/fsma

Page 3: FDA Updates on FSMA Implementation · 2018-05-21 · CGMP Inspections (FY18): What to Expect • Only inspections in FY18 will be for compliance with CGMPs for “large” and “small”

3

PCAFRule•  CurrentGoodManufacturingPracticeandHazardAnalysisandRisk-BasedPreventiveControlsforFoodforAnimals– 21CFRpart507– FinalRule:September15,2015

Page 4: FDA Updates on FSMA Implementation · 2018-05-21 · CGMP Inspections (FY18): What to Expect • Only inspections in FY18 will be for compliance with CGMPs for “large” and “small”

4

AvailableGuidance StatusCurrentGoodManufacturingPractice(#235)

Final

HazardAnalysisandPreventiveControls(#245)(chapters1-5)

Draft

FutureGuidance StatusSupply-ChainProgram Not

Available

FSMAGuidanceDocumentsmostrelevanttoDistillersGrainsManufacturers

www.fda.gov/fsma

Page 5: FDA Updates on FSMA Implementation · 2018-05-21 · CGMP Inspections (FY18): What to Expect • Only inspections in FY18 will be for compliance with CGMPs for “large” and “small”

5

FSMARegulationGuidanceDocumentsrelatedtoImportingAnimalFood

Guidance StatusForeignSupplierVerificationProgramsforImportersofFoodforHumansandAnimals

Draft

ApplicationoftheForeignSupplierVerificationProgramRegulationtoImportersofGrainRawAgriculturalCommodities

Final

Third-PartyCertificationBodyAccreditationforFoodSafetyAudits:ModelAccreditationStandards

Final

FDA'sVoluntaryQualifiedImporterProgram Final

Page 6: FDA Updates on FSMA Implementation · 2018-05-21 · CGMP Inspections (FY18): What to Expect • Only inspections in FY18 will be for compliance with CGMPs for “large” and “small”

6

PCAFHAPCGuidance•  Tohelpfacilitiesdevelopafoodsafetyplan(FSP)inaccordancewiththerequirementsofthePCAFRuleofpart507.–  Awrittenfoodsafetyplan(FSP)–  Hazardanalysis–  Preventivecontrols– Monitoring–  Correctiveactions–  Verification(includingvalidation)–  Recallplan–  Associatedrecords

HAPCGuidance#245

Page 7: FDA Updates on FSMA Implementation · 2018-05-21 · CGMP Inspections (FY18): What to Expect • Only inspections in FY18 will be for compliance with CGMPs for “large” and “small”

7

GuidanceStructure

Section Subject

Chapter1 TheFoodSafetyPlan

Chapter2 ConductingAHazardAnalysis

Chapter3 HazardsAssociatedwiththeManufacturing,Processing,Packing,andHoldingofAnimalFood

Chapter4 PreventiveControls

Chapter5 OverviewofPreventiveControlManagementComponents

AppendixA GlossaryofTerms

AppendixB TableofAbbreviationsandAcronymsusedinthisGuidance

AppendixC Flowchart–HazardAnalysis

AppendixD ExampleHazardAnalysisWorksheet

AppendixE AidtoIdentifyingAnimalFoodHazards

HAPCGuidance#245

Page 8: FDA Updates on FSMA Implementation · 2018-05-21 · CGMP Inspections (FY18): What to Expect • Only inspections in FY18 will be for compliance with CGMPs for “large” and “small”

8

Chapter1:FoodSafetyPlan

•  OverviewoftheFSP•  KeyPersonnel•  FSPandHACCP•  Formatting•  Reanalysis

HAPCGuidance#245

Page 9: FDA Updates on FSMA Implementation · 2018-05-21 · CGMP Inspections (FY18): What to Expect • Only inspections in FY18 will be for compliance with CGMPs for “large” and “small”

9HAPCGuidance#245

Chapter2:HazardAnalysis

•  Keyrequirements– Written–  HazardIdentification–  HazardEvaluation

•  Adefinitionfor“HazardAnalysis”

Page 10: FDA Updates on FSMA Implementation · 2018-05-21 · CGMP Inspections (FY18): What to Expect • Only inspections in FY18 will be for compliance with CGMPs for “large” and “small”

10

Chapter2:HazardAnalysis

•  RecommendedActivities– Preliminarysteps

•  Selectyourpreventivecontrolsqualifiedindividual•  Describetheanimalfood,itsdistribution,intendeduse,andtheintendedanimalspecies,lifestage,orproductionclass•  Developaprocessflowdiagramandverifythisdiagramonsite•  Describetheprocess

HAPCGuidance#245

Page 11: FDA Updates on FSMA Implementation · 2018-05-21 · CGMP Inspections (FY18): What to Expect • Only inspections in FY18 will be for compliance with CGMPs for “large” and “small”

11

Chapter2:HazardAnalysis

•  UseofaHazardAnalysisWorksheet(optional)•  ConductingaHazardsAnalysis– Severity– Probability

•  IdentifyHazardsRequiringaPreventiveControl•  IdentifyingPreventiveControls

HAPCGuidance#245

Page 12: FDA Updates on FSMA Implementation · 2018-05-21 · CGMP Inspections (FY18): What to Expect • Only inspections in FY18 will be for compliance with CGMPs for “large” and “small”

12HAPCGuidance#245

AppendixC:Flowchart–HazardAnalysis

Page 13: FDA Updates on FSMA Implementation · 2018-05-21 · CGMP Inspections (FY18): What to Expect • Only inspections in FY18 will be for compliance with CGMPs for “large” and “small”

13

AppendixD

•  ExampleHazardAnalysisWorksheet

(Column1)

IngredientandProcessingStep

(Column2)

KnownorReasonablyForeseeable

Hazard

(Column3)

DoestheKnownorReasonably

ForeseeableHazardRequirea

PreventiveControl?

“Yes”or“No”

(Column4)

Explanation/Justification

(Column5)

PreventiveControl(s)Applied

(Column6)

IsthePreventiveControlAppliedat

thisStep?

“Yes”or“No”

Page 14: FDA Updates on FSMA Implementation · 2018-05-21 · CGMP Inspections (FY18): What to Expect • Only inspections in FY18 will be for compliance with CGMPs for “large” and “small”

14HAPCGuidance#245

Chapter3:AnimalFoodHazards

•  Knownorreasonablyforeseeablehazardsinanimalfoodfacilitiesandthatmaybeapplicabletothefacilityandanimalfood.

•  Ingredient-related•  Process-related•  Facility-related

Page 15: FDA Updates on FSMA Implementation · 2018-05-21 · CGMP Inspections (FY18): What to Expect • Only inspections in FY18 will be for compliance with CGMPs for “large” and “small”

15

Chapter3:AnimalFoodHazards

•  Itdoesnotprovideanexhaustivecompilationofhazardsorextensivedetailsabouteachhazard

•  Hazardsaregeneralizedtoanimalfoodandtheseverityofillnessforspeciesand/orlifestagearenotprovided

•  ReferencesAppendixE

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16

AppendixE–AidtoIdentifyingFoodHazards

Page 17: FDA Updates on FSMA Implementation · 2018-05-21 · CGMP Inspections (FY18): What to Expect • Only inspections in FY18 will be for compliance with CGMPs for “large” and “small”

17

Chapter4:PreventiveControls

Theguidanceinthischapterisintendedtohelpfacilitiesthatmanufacture,process,pack,orholdanimalfoodtoidentifyandimplementpreventivecontrols.

HAPCGuidance#245

Page 18: FDA Updates on FSMA Implementation · 2018-05-21 · CGMP Inspections (FY18): What to Expect • Only inspections in FY18 will be for compliance with CGMPs for “large” and “small”

18

Chapter4:PreventiveControls

•  Processcontrolsincludeprocedures,practices,andprocessestoensurethecontrolofparametersduringoperations

•  Include– Parametersassociatedwithcontrolofthehazard– Maximumorminimumvalue,orcombinationofvalues

•  ParameterValuesvs.OperatingLimits

HAPCGuidance#245

Page 19: FDA Updates on FSMA Implementation · 2018-05-21 · CGMP Inspections (FY18): What to Expect • Only inspections in FY18 will be for compliance with CGMPs for “large” and “small”

19

Chapter4:PreventiveControls

•  Sanitationcontrolsincludeprocedures,practices,andprocessestoensurethatthefacilityismaintainedinasanitaryconditionadequatetosignificantlyminimizeorpreventhazardssuchasenvironmentalpathogensandbiologicalhazardsduetoemployeehandling.

•  Supply-chaincontrols

HAPCGuidance#245

Page 20: FDA Updates on FSMA Implementation · 2018-05-21 · CGMP Inspections (FY18): What to Expect • Only inspections in FY18 will be for compliance with CGMPs for “large” and “small”

20

Chapter5:PreventiveControl(PC)Management

Components•  Theguidanceprovidedinthischapterisintendedtohelpfacilitiesimplementthepreventivecontrolmanagementcomponents(PCmanagementcomponents)thatarepartoftheirfoodsafetyplan.

HAPCGuidance#245

Page 21: FDA Updates on FSMA Implementation · 2018-05-21 · CGMP Inspections (FY18): What to Expect • Only inspections in FY18 will be for compliance with CGMPs for “large” and “small”

21

Chapter5:PCManagementComponents

•  WhoisResponsible•  Monitoring•  CorrectiveActionsandCorrections•  VerificationActivities•  Reanalysis

HAPCGuidance#245

Page 22: FDA Updates on FSMA Implementation · 2018-05-21 · CGMP Inspections (FY18): What to Expect • Only inspections in FY18 will be for compliance with CGMPs for “large” and “small”

22

GuidanceSummary•  Thefirstfivechaptersprovideguidanceon:

–  thecomponentsofafoodsafetyplanandtheimportanceofeachcomponent

–  howtoconductahazardanalysisanddevelopafoodsafetyplanfortheanimalfoodthatyouproduce

–  thebiological,chemical(includingradiological),andphysicalagentsthatareknownorreasonablyforeseeablehazardsinmanufacturing,processing,packing,andholdingofanimalfood

–  identifyingpreventivecontrolsforbiological,chemical,andphysicalhazardsassociatedwithanimalfood

–  preventivecontrolmanagementcomponents–  recordkeepingrequirementsassociatedwiththefoodsafetyplanandimplementationofthefoodsafetyplan

HAPCGuidance#245

Page 23: FDA Updates on FSMA Implementation · 2018-05-21 · CGMP Inspections (FY18): What to Expect • Only inspections in FY18 will be for compliance with CGMPs for “large” and “small”

23

ThingstoKeepinMind•  Thereisflexibilityinhowtoapplytheserequirements

•  Facilitiesshouldtakeascientific-based,yetpractical,approachtoimplementation

•  Notallhazardswillbeahazardforallfacilities•  Focusonthepartsthatarerelevanttoyou•  Wewantyourcommentsandfeedback

HAPCGuidance#245

Page 24: FDA Updates on FSMA Implementation · 2018-05-21 · CGMP Inspections (FY18): What to Expect • Only inspections in FY18 will be for compliance with CGMPs for “large” and “small”

24

Applicabilityof

PCAFRegulationtoBy-ProductsfromAlcoholic

BeverageProduction

Page 25: FDA Updates on FSMA Implementation · 2018-05-21 · CGMP Inspections (FY18): What to Expect • Only inspections in FY18 will be for compliance with CGMPs for “large” and “small”

25www.fda.gov

HumanFoodBy-Product(HFBP)ForUseasAnimalFoodPCAFRuleFramework

Page 26: FDA Updates on FSMA Implementation · 2018-05-21 · CGMP Inspections (FY18): What to Expect • Only inspections in FY18 will be for compliance with CGMPs for “large” and “small”

26HAPCGuidance#245

CurrentApproachtoHFBP

www.fda.gov

•  InterimenforcementdiscretionforcertainM/Pactivities– GuidanceforIndustry:PolicyRegardingCertainEntitiesSubjecttotheCGMPandPreventiveControls,ProduceSafety,and/orForeignSupplierVerificationPrograms

•  Considerlong-termapproaches– BalanceprotectingpublichealthandpracticalapproachtoimplementingFSMArequirements

•  Continueddiscussionsandengagement

Page 27: FDA Updates on FSMA Implementation · 2018-05-21 · CGMP Inspections (FY18): What to Expect • Only inspections in FY18 will be for compliance with CGMPs for “large” and “small”

27HAPCGuidance#245

EnforcementDiscretion–HazardAnalysisandPCRequirements•  Facilitiessubjecttoandincompliancewithpart117thatareperformingcertainmanufacturing/processingactivitiesontheirhumanfoodby-productsforuseasanimalfood:–  drying/dehydrating,evaporating,pressing,chopping,andsimilaractivitiestoreduceweight,bulk,orvolume,and/or

–  mixing,centrifuging,andsimilaractivitiestocombineingredientsorseparatecomponents(e.g.,waterandsolids)and

–  Activitiesarenotperformedtopreventorsignificantlyminimizeanimalfoodhazardsanddonotintroduceanimalfoodhazards.

www.fda.gov

Page 28: FDA Updates on FSMA Implementation · 2018-05-21 · CGMP Inspections (FY18): What to Expect • Only inspections in FY18 will be for compliance with CGMPs for “large” and “small”

28

ImplementationUpdate

Page 29: FDA Updates on FSMA Implementation · 2018-05-21 · CGMP Inspections (FY18): What to Expect • Only inspections in FY18 will be for compliance with CGMPs for “large” and “small”

29

CGMPInspections(FY18):WhattoExpect

•  OnlyinspectionsinFY18willbeforcompliancewithCGMPsfor“large”and“small”businesses

•  CGMPinspectionsstartedinOctober2017•  Increasednumberofinspections•  InspectionsbeingdonebyFDAandstateinspectors

Page 30: FDA Updates on FSMA Implementation · 2018-05-21 · CGMP Inspections (FY18): What to Expect • Only inspections in FY18 will be for compliance with CGMPs for “large” and “small”

30

•  WewillNOTinspectall“large”and“small”businesses

•  CGMPinspectionsmaybecombinedwithBSEinspections

•  Wewillcontinueto“EducateBeforeandDuring”Regulation

CGMPInspections(FY18):WhattoExpect

Page 31: FDA Updates on FSMA Implementation · 2018-05-21 · CGMP Inspections (FY18): What to Expect • Only inspections in FY18 will be for compliance with CGMPs for “large” and “small”

31

CGMPInspectionsatEthanolFacilities

•  7inspectionsconductedasofApril,2018•  Nomajorconcernswereobserved•  MinorFindings:thepotentialforcontaminationofanimalfoodduringstorage– pests–  foreignmaterials– mold

Page 32: FDA Updates on FSMA Implementation · 2018-05-21 · CGMP Inspections (FY18): What to Expect • Only inspections in FY18 will be for compliance with CGMPs for “large” and “small”

32

Inspections–LookingbeyondFY18•  PCInspectionsstarting:– Oct2018for“large”businesses–  Jan2019(atearliest)for“small”businesses

•  FDAworkingtoupdateinspectionprogram– Combiningdifferenttypesofinspections– WillimpactourworkplanningforbothFDAandstates

Page 33: FDA Updates on FSMA Implementation · 2018-05-21 · CGMP Inspections (FY18): What to Expect • Only inspections in FY18 will be for compliance with CGMPs for “large” and “small”

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