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FocusonPrevention
FDAFoodSafety
ModernizationAct
AgendaThepublichealthimperativeWhyisthelawneeded?Provisionsofthelaw,focusonpreventionImplementationtimelineandplansWhyisthelawneeded?FoodborneillnessisasignificantburdenAbout48million(1in6Americans)getsickeachyear128,000arehospitalized3,000dieFoodsupplymorehigh-techandcomplex15percentofU.S.foodsupplyisimportedMorefoodsinthemarketplaceNewhazardsinfoodsnotpreviouslyseenMainThemesoftheLegislationPreventionInspections,Compliance,andResponseImportSafetyEnhancedPartnershipsPrevention:TheCornerstoneComprehensivepreventivecontrolsforhumanandanimalfoodfacilitiesPreventionisnotnew,butCongresshasgivenFDAexplicitauthoritytousethetoolmorebroadlyStrengthensforpreventionProducesafetystandardsIntentionaladulterationstandardsTransportationGeneralApproachtoPreventiveControls5.Review&Adjust1.IdentifyHazard2.UnderstandCause3.ImplementPreventiveControls4.MonitorEffectivenessPreventionStandardsMandates
Sec.103.Hazardanalysisandrisk-basedpreventivecontrolsRequireshumanandanimalfoodfacilitiesto:Evaluatehazardsthatcouldaffectfoodsafety;Identifyandimplementpreventivecontrolstopreventhazards;Monitorcontrolsandmaintainmonitoringrecords;andConductverificationactivities.ModifiedRequirementsforQualifiedFacilities(Section103)Facilityisexemptif:Definedasverysmallbusiness;
ORThefacilityhasalimitedannualmonetaryvalueofsalesModifiedRequirementsforQualifiedFacilities(Section103)Limitedannualmonetaryvalueofsalesisdefinedas:Duringthelast3years,saleswerelessthan$500,000;
ANDSalesto"QualifiedEndUsers"exceedsalestoothersExamplesofCompliancewith
PreventionStandardsSanitationTrainingforsupervisorsandemployeesEnvironmentalcontrolsandmonitoringFoodallergencontrolsRecallcontingencyplanGoodManufacturingPractices(GMPs)SupplierverificationactivitiesPreventionStandardsMandates
Sec.105.StandardsforProduceSafetyEstablishscience-based,minimumstandardsforthesafeproductionandharvestingoffruitsandvegetablesAppliestorawagriculturalcommoditiesforwhichFDAdeterminesthatsuchstandardsminimizetheriskofseriousadversehealthconsequencesordeath.
ExemptionforDirectFarmMarketing(Sec.105)Farmsexemptif:Duringthelast3years,saleswerelessthan$500,000andMajorityofproductisdistributeddirectlytoconsumersorfarmers’marketsandrestaurantseitherintrastateorwithina275-mileradiusIntentionalContaminationSec.106.ProtectionagainstIntentionalAdulterationIssuefinalruleandguidancetoprotectagainsttheintentionaladulterationoffoodConductvulnerabilityassessmentsofthefoodsupplyanddeterminemitigationstrategiesSec.108PrepareaNationalAgricultureandFoodDefenseStrategywithUSDA,andDHSPreventionStandardsMandatesSec.111.SanitaryTransportationofFoodAddressesimplementationoftheSanitaryFoodTransportationActof2005,whichrequirespersonsengagedinfoodtransportationtousesanitarytransportationpracticestoensurethatfoodisnottransportedunderconditionsthatmayrenderitadulterated.
PreventioninImportsSec.301ForeignSupplierVerificationProgram(FSVP)Requiresimporterstoconductrisk-basedforeignsupplierverificationactivitiestoverifythatfoodimportedintotheUnitedStatesisnotadulteratedandthatitwasproducedincompliancewithFDA’spreventivecontrolsrequirementsandproducesafetystandardsSec.307.ThirdPartyAuditorAccreditationCanbeusedbyimportersforsupplierverificationunderFSVPImplementationApproachItemsareprioritizedbasedonpublichealthprotectionEngagewithstakeholderstohelpdeterminereasonableandpracticalwaystoimplementpreventivecontrolprovisionsImplementationprogressatStrategicCommunications&OutreachTeam–SharonNatanblutPreventionStandardsDonKraemerInspection&ComplianceBarbaraCassensImportsRobertaWagnerImporterVerification&VQIPAccreditedThird-PartyCertificationLabAccreditation&IntegratedConsortium/FERNFeesRoxanneSchweitzerFederal/StateIntegrationJoeReardonReports&StudiesDavidDorsey
OperationalPartnershipCapacityBuildingProduceSafetyRegulationProduceSafetyGuidancePreventiveControlsRegulationPreventiveControlsGuidanceMandatoryRecall/RecallCommunicationsTracing
Inspection&AuditorFeesReportstoCongress/StudiesComparabilityTaskA:PriorNoticeTrainingFrequencyofInspectionAdministrativeEnforcementToolsSafeFoodTransportFoodDefense
ContaminantsImportCertificationRegistrationRFRImprovementsMannerofInspection/FoodSafetyPlanReviewInternationalCapacityBuildingImplementationExecutiveCommitteePreventionProjectsCompleted
(asofOctober2021)PublicMeetingonPreventiveControlsforFacilities(4/20/11)PreventiveControlsforRegisteredHumanFoodandAnimalFood/FeedFacilitiesDocketFDA-2021-N-0238(5/23/11)Toursoffarmsandfood/facilitiesOutreachRecentFarmtouratMilkPailFarmOutreachUpcomingpublicmeetingsonpreventivecontrolsandproducesafetywhenproposalsareissuedNumerouslisteningsessions,meetings,pre
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