food safety by design focus on fsma prevenve controls · food safety by design focus on fsma...
TRANSCRIPT
Presentedby:Dr.DavidAcheson
FoodSafetyByDesignFocusonFSMAPreven<veControls
Overview
• WhydidFSMApassCongress• WhatisthegoalofthePreven9veControlRule• Approachtobuildingafoodsafetyplan• Environmentalmonitoringprogram• SupplychaincontrolPCruleandFSVP• RoleofGFSI
WhywasFSMAPassedbyCongress?
• Seriesofmajoroutbreaks– Spinach-E.coliO1572006– PeanutbuNer–Salmonella2007– Petfood–melamine2007– PeanutbuNer–Salmonella2009
• Desireonmul9plefrontstochangerequirements– Consumerorganiza9ons– Privatesector– FDA– Congress
FDAExpecta<ons
• Iden9fyalltheriskspertainingtothefoodyoumanufacture,processpackorhold
• Determinewhichrisksneedtobecontrolledtopreventfoodborneillness
• Understandhowtocontroltherisks(inplantandsupplychain)
• Makesurethatthoserisksarebeingcontrolled• Trackthatthesystemsareworkingeveryday
IsFSMAaBunchof“BusyWork”
• Whatkeepsafoodcompanyexecu9veawakeatnight• Regulatorycompliance• Economicpressuresonthecompany• Innova9on• Recalls
• Protec9ngthebrand• Riskbasedpreven9vecontrolswillprotectabrand
FinalPreven<veControlsRuleKeyPrinciples
• Riskbased• Focusedonpreven9on• EachfacilitywouldberequiredtoimplementawriNenfoodsafetyplanthatfocusesonpreven9ng“hazardsrequiringpreven9vecontrols”
• Iden9fy“HazardsRequiringPreventa9veControl”• Implementpreven9vecontrols• Monitor,verify,validate,correc9veac9ons• Keeprecords
• FDAcaninspectyourfoodsafetyplan• FoodSafetyPlanConsidereda“TradeSecret”–NoFOIA
FacilityRegistra<on
• Doesyourfacilitymanufacture,process,pack,orholdfood?
• Thenneedtoregisterunlessexempt• Nextfacilityregistra9onisdueNovember,2018
Exemp<ons
• Alcoholicbeveragesandfoodproducedatsamesolongasitisinprepackagedformandcons9tuteslessthan5%overallsales
• PasteurizedMilkOrdinanceRegulatedFacili9es-extended• Retail• Restaurants• USDA• SeafoodHACCP• JuiceHACCP• LACFforMicrorisks• Farms(primaryandsecondary)
Exemp<ons-Warehouses
– Solelyengagedinthestorageofunexposedpackagedfoods–don’tneedtocomplywithCandGunlessmodifiedrequirements(refrigera9on)
– SolelyengagedinthestorageofRAC’s(otherthanproduce)intendedforfurtherprocessing
– Solelyengagedintheholdingand/ortransporta9onofRAC’s(otherthanproduce)
TheFoodSafetyPlan
• Youmustprepare,orhaveprepared,andimplementawriNenfoodsafetyplan.
• Thefoodsafetyplanmustbeprepared,oritsprepara9onoverseen,byoneormorepreven<vecontrolsqualifiedindividuals.
• REMINDER!Preven&vecontrolsqualifiedindividualmeansaqualifiedindividualwhohassuccessfullycompletedtraininginthedevelopmentandapplica9onofrisk-basedpreven9vecontrolsatleastequivalenttothatreceivedunderastandardizedcurriculumrecognizedasadequatebyFDAorisotherwisequalifiedthroughjobexperiencetodevelopandapplyafoodsafetysystem.
TheFoodSafetyPlan
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HazardAnalysis
Preven9veControls
Monitoring
Correc9veAc9ons
Verifica9on
Reanalysis
Documenta<on
MorethanHACCP
• Thinkofallthefoodsafetyrisksinthefacility• Whichonesrisetothelevelofa“riskthatrequiresa
preven9vecontrol”• Howdoyoucontrolthoserisks
– WithaCCPe.g.cooking– Withaprerequisiteprograme.g.environmentalcontrol
– Withhandwashing– Otherways–supplychaincontrol
• Doalltheseiden9fiedrisksrequireaCCP
HACCPvs.HARPCvs.PRPs
Preven9veControls
Risksthatrequirepreven9vecontrol
PRPsHACCPCCPs
RemainingPRPs
• Example: • Environmental contamination • Allergen control
HazardAnalysis
• Conductahazardanalysistoiden9fyandevaluateknownorreasonablyforeseeablehazardsforeachtypeoffoodmanufactured,processed,packedorheld
• Whichhazardsrequireapreventa9vecontrol– Mustconsiderbiological,chemical(radiological),andphysical– Considerhazardsthat:
• Occurnaturally• Uninten9onallyintroduced• Inten9onallyintroducedforeconomicgain
• Consider– Severityoftheillness– Probabilityofillnessorinjuryifthehazardisnotcontrolled– Mustincludeanevalua9onofenvironmentalpathogens
HazardAnalysis
• Mustconsider– Formula9onofthefood– Condi9on,func9onanddesignofthefacility– Transporta9onprac9ces– Manufacturing/processingprocedures– Packagingandlabelingac9vi9es– Storageanddistribu9on– Intendedorreasonablyforeseeableuse– Sanita9onincludingemployeehygiene– Anyotherrelevantfactors(e.g.weatherrelated)
HazardAnalysis
• Whatare“Hazardsrequiringapreven9vecontrol”– Aknownorreasonablyforeseeablehazardforwhichapersonknowledgeableaboutthesafemanufacturing,processing,packing,orholdingoffoodwould…….
• basedontheoutcomeofahazardanalysis(whichincludesanassessmentoftheseverityoftheillnessorinjuryifthehazardweretooccurandtheprobabilitythatthehazardwilloccurintheabsenceofpreven9vecontrols),
– establishoneormorepreven9vecontrolstosignificantlyminimizeorpreventthehazard
Preven<veControls
• Iden9fyandimplementpreven9vecontrolstoprovideassurancethatthehazardissignificantlyminimizedorpreventedtoavoidadultera9on– MaybeCCPs– MaybecontrolsotherthanCCPs
• MustbewriNen• Maybeprocesscontrols
– Includethenatureoftheprocesscontrol– Iden9fythemaximumorminimumvaluetowhichtheparameter
shouldbecontrolled• Allergencontrols
– Protec9onagainstcrosscontactcontamina9on– Labeling/labelverifica9on
Preven<veControls
• Sanita9onControlsformicrobialandallergenrisks– Cleanlinessoffoodcontactsurfaces– Preven9onofallergencrosscontactandcross-contamina9on
• Supplychaincontrols(detailsinSubpartG)• Recallplan• Othercontrolsasneeded(hygienetrainingandcGMPs)
Monitoring(§117.145)
• Asappropriateforthenatureofthepreven9vecontrol– WriNenproceduresincludingfrequency– Adequatefrequencytoprovideassurancethattheyareconsistentlyperformed
– Recordkeeping• Mustdocumentinaccordancewithverifica9onandrecordsreview
– Excep9onrecords• E.g.9me/temperaturecontrolwhenrecordsshowlossoftemperaturecontrol
• Maybeadequateinothercircumstancestoo• Versesaffirma9onrecords
Correc<veAc<ons(§117.150)
• Asappropriatetothenatureofthehazardandthenatureofthepreven9vecontrol– MustbewriNenandtobetakenifpreven9vecontrolsarenot
properlyimplementedincludingprocedurestoaddressasappropriate
• PresenceofapathogenorappropriateindicatorinRTEproduct
• Presenceofenvironmentalpathogenorindicator– Proceduresmustdescribethesteps
• Iden9fyandcorrecttheproblem• Reducethelikelihoodthattheproblemwillrecur• Allaffectedfoodisevaluatedforsafety• Allaffectedfoodispreventedfromenteringcommerce
Correc<veAc<ons(§117.150)
• Correc9ons(avoidstheneedforacorrec9veac9on)– Youtakeac9onina9melymannertoiden9fyandcorrectcondi9onsandprac9cesthatarenotconsistentwithallergencontrolsornotconsistentwithsanita9oncontrols
– Aminorproblemthatdoesnotdirectlyimpactproductsafety
• Records– Allcorrec9veac9ons(andwhereappropriatecorrec9ons)mustbedocumented.
– Subjecttoverifica9onandrecordsreview
Verifica<on(§117.155)
• Mustinclude– Valida9oninaccordancewith§117.160– Thatmonitoringisbeingconductedappropriately
– Thatappropriatedecisionsaremadeaboutcorrec9veac9ons
– Verifica9onofimplementa9onandeffec9venessofthepreven9vecontrols
– Reanalysisisdoneappropriately– Fullydocumented
Valida<on(§117.160)
• Mustvalidatethepreven9vecontrols• Valida9onmust:
– BeperformedoroverseenbyaPCQI– Bedonepriortotheimplementa9onofthefoodsafetyplan– Beperformedasnecessarytodemonstratecontrolmeasurescan
beimplementedasdesigned:• Within90daysaperproduc9onoftheapplicablefoodbeginsOR
• Withinareasonable9meframewithjus9fica9on– Mustbepreformediftherearechangesthatmayimpactcontrol
ofthehazard– Mustbeperformedifareanalysisindicatestheneedforit
FinishedProductTes<ng
• Producttes9ngwhichmustbe– Bescien9ficallyvalid– Iden9fythetestmicroorganism(s)orotheranalyte(s)– Specifytheproceduresforiden9fyingsamples,including
theirrela9onshiptospecificlotsofproduct;– Includetheproceduresforsampling,includingthe
numberofsamplesandthesamplingfrequency– Iden9fythetest(s)conducted,includingtheanaly9cal
method(s)used;– Iden9fythelaboratoryconduc9ngthetes9ng– Includecorrec9veac9onprocedures
EnvironmentalMonitoring
• Environmentalmonitoringwouldberequired– WhereRTEproductisexposedtotheenvironmentpriortopackagingandthepackagedfooddoesnotreceiveatreatmentthatwouldsignificantlyminimizeanenvironmentalpathogenthatcouldcontaminatethefoodwhenitisexposed.
• Rou9netes9ngdoesnothavetobeconductedbyanaccreditedlab,thetestmethodmustbescien9ficallyvalid,andresultsdonotneedtobesenttotheFDA
Verifica<on(§117.165)
• Environmentalmonitoringmust– Bescien9ficallyvalid;– Iden9fythetestmicroorganism(s);– Iden9fytheloca9onsfromwhichsampleswillbecollectedandthenumber
ofsitestobetestedduringrou9neenvironmentalmonitoring.• Thenumberandloca9onofsamplingsitesmustbeadequatetodeterminewhetherpreven9vecontrolsareeffec9ve
– Iden9fythe9mingandfrequencyforcollec9ngandtes9ngsamples.• Mustbeadequatetodeterminewhetherpreven9vecontrolsareeffec9ve;
– Iden9fythetest(s)conducted,includingtheanaly9calmethod(s)used– Iden9fythelaboratoryconduc9ngthetes9ng– Includethecorrec9veac9onprocedures
Reanalysis(§117.170)
• Onceevery3years• Asneeded
– Whenasignificantcreatesareasonablepoten9alforanewhazardorcreatesasignificantincreaseinapreviouslyiden9fiedhazard;
– Whenyoubecomeawareofnewinforma9onaboutpoten9alhazardsassociatedwiththefood
– Unan9cipatedfoodsafetyproblem– Wheneveryoufindthatapreven9vecontrolisineffec9ve
• WhenFDAtellsyouneedto
FSMAApproachtoSupplyChainControl
• Preven9veControlsRule(HumanandAnimalFood)– Registeredfirmsmustassesssupplychainrisk– Ifsuppliersareresponsibleforcontrollingrisk,thecustomermustverifythattheriskisbeingcontrolled
• ForeignSupplierVerifica9onProgram– Shiptheburdenofensuringsafefoodtoimporters– Importersrequiredtoperformrisk-basedac9vi9estoverifythatfoodimportedintotheU.S.istothesamefoodsafetystandardsasthoserequiredofU.S.producers.
FSMAApproachtoSupplyChainControl
• DoyouneedtocomplywiththePCrule?– NeedsupplychaincontrolaspartofPCrequirement
• AreyouanimporteroffoodthatdoesnotneedtobecompliantwiththePCrule– NeedtobecompliantwithFSVP
FSMAApproachtoSupplyChainControl
• Hazardanalysis• Evaluatetherisks–whoiscontrollingtherisk• Supplierverifica9onthatriskarebeingcontrolled• Useonlyapprovedsuppliers• Documentcorrec9veac9ons• Buildaprogramandkeeprecords
FSMAPreven<veControlRules–SupplyChainProgram
• Thereceivingfacilitymustestablishandimplementarisk-basedsupply-chainprogramforthoserawmaterialsandotheringredientsforwhichthereceivingfacilityhasiden9fiedahazardrequiringasupply-chain-appliedcontrol
• ProgrammustbewriNen• Whenappliedbyanen9tyotherthanthereceivingfacility’ssupplier
facilitymust– Verifythesupply-chain-appliedcontrol;or– Labelfoodasnothavingtheriskcontrolled;and,– Obtaindocumenta9onofanappropriateverifica9onac9vityfromanother
en9ty,reviewandassesstheen9ty’sapplicabledocumenta9on,anddocumentthatreviewandassessment
ImportersResponsibili<es
• Determiningthehazardsreasonablylikelytocauseillnessorinjurywitheachfood
• Evalua9ngtheriskposedbyafood,usingtheresultsofthehazardanalysis,andevalua9ngtheforeignsupplier’sperformance
• Conduc9ngsupplierverifica9onac9vi9es.Ingeneral,importersmustestablishandfollowwriNenprocedurestoensuretheyonlyimportfoodsfromforeignsupplierstheyhaveapproved
Exemp<ons
• Certainjuice,fish,andfisheryproductsunderthecurrentHACCPrules
• Foodforresearchorevalua9on• Foodforpersonalconsump9on• Alcoholicbeverages• Foodthatistransshipped• Foodimportedforprocessingandfutureexport• FoodexportedfromandreturnedtotheUnitedStates
withoutmanufacturing/processinginaforeigncountry• Certainmeat,poultry,andeggproductsregulatedbytheU.S.
DepartmentofAgriculture(USDA)
SupplyChainProgram-Verifica<on
• Ifthehazardisbeingcontrolledbythesupplierandisoneforwhichthereisareasonableprobabilitythatexposuretothehazardwillresultinseriousadversehealthconsequencesordeathtohumans:– Theappropriatesupplierverifica9onac9vityisanonsiteauditofthesupplier;and
– Theauditmustbeconductedbeforeusingtherawmaterialorotheringredientfromthesupplierandatleastannuallythereaper
SupplyChainProgram-Verifica<on
• Onsiteauditmustbeperformedbyaqualifiedauditor• Iftherawmaterialorotheringredientatthesupplierissubjectto
oneormoreFDAfoodsafetyregula9ons,anonsiteauditmustconsidersuchregula9onsandincludeareviewofthesupplier’swriNenplan(e.g.,HazardAnalysisandCri9calControlPoint(HACCP)planorotherfoodsafetyplan)
• Varioussubs9tu9onsforonsiteaudit– WriNenresultsofanappropriateinspec9onbyFDA,byotherFederalAgenciesorbyState,local,tribalorterritorialagencies
– IfforeignmaybeFDAorcountryrecognizedbyFDA
FSMAandGFSI(§117.330)
• Totheextentthatanexis9ngHACCPplanorGFSI-compliantfoodsafetyplanincludesallrequiredinforma9on,afacilitycanusesuchplanstomeettherequirementsofthisrule.
• Relyingonexis9ngrecords,withsupplementa9onasnecessarytodemonstratecompliancewiththerequirementsofthehumanpreven9vecontrolsrule,isacceptable.
• Couldbeasetofdocumentskeptindifferentloca9onswithinthefacility,withalistoftherelevantdocuments(e.g.TableofContents).– LeveragePRPsasneeded
AreasofDifference
• GFSIisHACCPfocused– CCPsandprerequisiteprograms
• FSMAisHARPCfocused– Risksthatrequireapreven9vecontrol– Avoidscrea9ngCCPsforallrisks
• Whenimplementedproperlybothwillprotectthefoodsupply
GFSISchemes
• TheAchesonGrouphascomparedseveralGFSIschemeswithFSMAPreven9veControlRules– SQF– BRC– FSSC
• Allmatchupwellandareessen9allyeithercomparableorexceedingFSMA.
FFutureFSMAChallenges
Build
Maintain
Maintain
Build
FutureNow
Summary
• CompliancewithFSMAPreven9vecontrolruleswillreducebrandrisk– Supplychainriskcontrol– Environmentalcontrolprograms
• Recordkeepingiscri9cal• Maintaintheprogramdon’tjustbuilditandwalkaway
• BeingGFSIcompliantisagoodstarttoFSMAcompliance
ThankYouQues<ons?