food safety by design focus on fsma prevenve controls · food safety by design focus on fsma...

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

1111

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.


•  DoyouneedtocomplywiththePCrule?–  NeedsupplychaincontrolaspartofPCrequirement

•  AreyouanimporteroffoodthatdoesnotneedtobecompliantwiththePCrule–  NeedtobecompliantwithFSVP


•  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?

food safety by design focus on fsma prevenve controls · food safety by design focus on fsma...

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