FDA Updates on FSMA Implementation · 2018-05-21 · CGMP Inspections (FY18): What to Expect •...
Transcript of FDA Updates on FSMA Implementation · 2018-05-21 · CGMP Inspections (FY18): What to Expect •...
FDAUpdatesonFSMAImplementation
Dr.MarlaKeller,CenterforVeterinaryMedicineFoodandDrugAdministration
DistillersGrainTechnologyConferenceDesMoines,Iowa-May17,2018
www.fda.gov
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FSMABackground
• AppliestoallfacilitiesthatarerequiredtoregisterwithFDAbecausetheymanufacture,process,pack,orholdfoodforconsumptionintheU.S.
• “Food”and“Animalfood”includearticlesusedforcomponentsoffood,suchasrawmaterialsorotheringredients– TheFD&CAct§201(f)– 21CFR507.3definitions
• DraftGuidanceforIndustry:QuestionsandAnswersRegardingFoodFacilityRegistration(SeventhEdition)– www.fda.gov/fsma
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PCAFRule• CurrentGoodManufacturingPracticeandHazardAnalysisandRisk-BasedPreventiveControlsforFoodforAnimals– 21CFRpart507– FinalRule:September15,2015
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AvailableGuidance StatusCurrentGoodManufacturingPractice(#235)
Final
HazardAnalysisandPreventiveControls(#245)(chapters1-5)
Draft
FutureGuidance StatusSupply-ChainProgram Not
Available
FSMAGuidanceDocumentsmostrelevanttoDistillersGrainsManufacturers
www.fda.gov/fsma
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FSMARegulationGuidanceDocumentsrelatedtoImportingAnimalFood
Guidance StatusForeignSupplierVerificationProgramsforImportersofFoodforHumansandAnimals
Draft
ApplicationoftheForeignSupplierVerificationProgramRegulationtoImportersofGrainRawAgriculturalCommodities
Final
Third-PartyCertificationBodyAccreditationforFoodSafetyAudits:ModelAccreditationStandards
Final
FDA'sVoluntaryQualifiedImporterProgram Final
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PCAFHAPCGuidance• Tohelpfacilitiesdevelopafoodsafetyplan(FSP)inaccordancewiththerequirementsofthePCAFRuleofpart507.– Awrittenfoodsafetyplan(FSP)– Hazardanalysis– Preventivecontrols– Monitoring– Correctiveactions– Verification(includingvalidation)– Recallplan– Associatedrecords
HAPCGuidance#245
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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
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Chapter1:FoodSafetyPlan
• OverviewoftheFSP• KeyPersonnel• FSPandHACCP• Formatting• Reanalysis
HAPCGuidance#245
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Chapter2:HazardAnalysis
• Keyrequirements– Written– HazardIdentification– HazardEvaluation
• Adefinitionfor“HazardAnalysis”
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Chapter2:HazardAnalysis
• RecommendedActivities– Preliminarysteps
• Selectyourpreventivecontrolsqualifiedindividual• Describetheanimalfood,itsdistribution,intendeduse,andtheintendedanimalspecies,lifestage,orproductionclass• Developaprocessflowdiagramandverifythisdiagramonsite• Describetheprocess
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Chapter2:HazardAnalysis
• UseofaHazardAnalysisWorksheet(optional)• ConductingaHazardsAnalysis– Severity– Probability
• IdentifyHazardsRequiringaPreventiveControl• IdentifyingPreventiveControls
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AppendixC:Flowchart–HazardAnalysis
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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”
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Chapter3:AnimalFoodHazards
• Knownorreasonablyforeseeablehazardsinanimalfoodfacilitiesandthatmaybeapplicabletothefacilityandanimalfood.
• Ingredient-related• Process-related• Facility-related
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Chapter3:AnimalFoodHazards
• Itdoesnotprovideanexhaustivecompilationofhazardsorextensivedetailsabouteachhazard
• Hazardsaregeneralizedtoanimalfoodandtheseverityofillnessforspeciesand/orlifestagearenotprovided
• ReferencesAppendixE
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AppendixE–AidtoIdentifyingFoodHazards
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Chapter4:PreventiveControls
Theguidanceinthischapterisintendedtohelpfacilitiesthatmanufacture,process,pack,orholdanimalfoodtoidentifyandimplementpreventivecontrols.
HAPCGuidance#245
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Chapter4:PreventiveControls
• Processcontrolsincludeprocedures,practices,andprocessestoensurethecontrolofparametersduringoperations
• Include– Parametersassociatedwithcontrolofthehazard– Maximumorminimumvalue,orcombinationofvalues
• ParameterValuesvs.OperatingLimits
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Chapter4:PreventiveControls
• Sanitationcontrolsincludeprocedures,practices,andprocessestoensurethatthefacilityismaintainedinasanitaryconditionadequatetosignificantlyminimizeorpreventhazardssuchasenvironmentalpathogensandbiologicalhazardsduetoemployeehandling.
• Supply-chaincontrols
HAPCGuidance#245
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Chapter5:PreventiveControl(PC)Management
Components• Theguidanceprovidedinthischapterisintendedtohelpfacilitiesimplementthepreventivecontrolmanagementcomponents(PCmanagementcomponents)thatarepartoftheirfoodsafetyplan.
HAPCGuidance#245
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Chapter5:PCManagementComponents
• WhoisResponsible• Monitoring• CorrectiveActionsandCorrections• VerificationActivities• Reanalysis
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GuidanceSummary• Thefirstfivechaptersprovideguidanceon:
– thecomponentsofafoodsafetyplanandtheimportanceofeachcomponent
– howtoconductahazardanalysisanddevelopafoodsafetyplanfortheanimalfoodthatyouproduce
– thebiological,chemical(includingradiological),andphysicalagentsthatareknownorreasonablyforeseeablehazardsinmanufacturing,processing,packing,andholdingofanimalfood
– identifyingpreventivecontrolsforbiological,chemical,andphysicalhazardsassociatedwithanimalfood
– preventivecontrolmanagementcomponents– recordkeepingrequirementsassociatedwiththefoodsafetyplanandimplementationofthefoodsafetyplan
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ThingstoKeepinMind• Thereisflexibilityinhowtoapplytheserequirements
• Facilitiesshouldtakeascientific-based,yetpractical,approachtoimplementation
• Notallhazardswillbeahazardforallfacilities• Focusonthepartsthatarerelevanttoyou• Wewantyourcommentsandfeedback
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Applicabilityof
PCAFRegulationtoBy-ProductsfromAlcoholic
BeverageProduction
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HumanFoodBy-Product(HFBP)ForUseasAnimalFoodPCAFRuleFramework
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CurrentApproachtoHFBP
www.fda.gov
• InterimenforcementdiscretionforcertainM/Pactivities– GuidanceforIndustry:PolicyRegardingCertainEntitiesSubjecttotheCGMPandPreventiveControls,ProduceSafety,and/orForeignSupplierVerificationPrograms
• Considerlong-termapproaches– BalanceprotectingpublichealthandpracticalapproachtoimplementingFSMArequirements
• Continueddiscussionsandengagement
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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
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ImplementationUpdate
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CGMPInspections(FY18):WhattoExpect
• OnlyinspectionsinFY18willbeforcompliancewithCGMPsfor“large”and“small”businesses
• CGMPinspectionsstartedinOctober2017• Increasednumberofinspections• InspectionsbeingdonebyFDAandstateinspectors
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• WewillNOTinspectall“large”and“small”businesses
• CGMPinspectionsmaybecombinedwithBSEinspections
• Wewillcontinueto“EducateBeforeandDuring”Regulation
CGMPInspections(FY18):WhattoExpect
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CGMPInspectionsatEthanolFacilities
• 7inspectionsconductedasofApril,2018• Nomajorconcernswereobserved• MinorFindings:thepotentialforcontaminationofanimalfoodduringstorage– pests– foreignmaterials– mold
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Inspections–LookingbeyondFY18• PCInspectionsstarting:– Oct2018for“large”businesses– Jan2019(atearliest)for“small”businesses
• FDAworkingtoupdateinspectionprogram– Combiningdifferenttypesofinspections– WillimpactourworkplanningforbothFDAandstates
Questions?