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FoodEmergencyResponseNetwork

(FERN)

FDAScienceBoardAdvisoryCommitteeMeeting

November6,2003CarlJ.SciacchitanoOfficeofRegulatoryAffairs/DivisionofFieldScienceMissionofFERNIntegratethenation’sfood-testinglaboratoriesforthedetectionofthreatagentsinfoodatthelocal,state,andfederallevels.Detectionofbiological,chemicalandradiologicalagents.FERNObjectivesPrevention–federal/statesurveillancesamplingprogramsPreparedness–strengtheninglabcapabilities/capacitiesResponse–surgecapacityRecovery–provideassurancetotheconsumerDirectivefromtheInteragencyFoodWorkingGroup BuildanintegratednetworkoffoodtestinglaboratoriesCooperatewithfederalandstatepartnersDoitnow!FoodLaboratoriesareMission-CriticalResourcesOutbreakInvestigationRoutineSurveillanceRegulatoryComplianceMethodValidation

EmergencyResponseTrainingFoodLaboratories:EnvironmentalVeterinaryDiagnosticAgriculturalClinicalFederalConsumerComplaintsCTSurveillanceProficiencyTestingFERNStructureRegionalCoordinationCenters范文/

范文大全/

FERNSteeringCommitteeFERNNationalOperationsCenter(FERNSupportPrograms)SoutheastSouthwestNortheastNorthwestCentralFERNSteeringCommitteeMembersFederalHHS,FDA-ORA,FDA-CFSAN,CDCUSDA-FSIS,USDA-APHIS,USDA-AMS,USDA-GIPSA,USCustoms,DoD,FBI,EPAStateAgriculturePublicHealthVeterinaryDiagnosticFERNStructure:SteeringCommitteeFERNSteeringCommitteeResponsibilitiesDevelopFERNguidelines,policiesandproceduresCoordinate,integrateanddevelopnationalresourcestosupportFERNOverseeFERNNationalOperationsCenterProvideguidancetoFERNSupportProgramsFERNStructure:SteeringCommittee

FERNNationalOperationsCenter-ResponsibilitiesResponsiblefordaytodayoperationofFERNOperatedbyfulltimestaffReportstoFERNSteeringCommitteeOverseeimplementationofpolicies/proceduresCoordinateRegionalCoordinationCenter(RCC)activitiesManageandcoordinateFERNSupportProgramsCoordinatemeetingsofFERNcomponentsCoordinatecommunicationsEvaluateneeds/capabilitiesDevelop/proposebudgettoSteeringCommitteeConductexercisesCoordinateemergencyresponseFERNStructure:NationalOperationsCenterFERNSupportPrograms–Sub-committeesTrainingProficiencyTestingMethodDevelopment/ValidationSurveillanceElectroniccommunicationFERNStructure:SupportProgramsTrainingPerformedBSL-3RapidIDMethodsfortheDetectionofB.anthracis,October2002BSL-3FoodEnrichmentTechniquesfortheDetectionofB.anthracis,October2002FoodSamplePreparationandOrganismEnrichmentMethodsforBSL-3Labs,December2002-16stateparticipantsBSL-3RapidIDMethodsandFoodEnrichmentTechniquesfortheDetectionofB.anthracis,January2003-6stateparticipantsBSL-3Yersiniapestis,Francisellatularensis,andB.anthracistrainingcourse,February2003BSL-3RapidIDandfoodEnrichmentTechniquesfortheDetectionofB.anthracisTraintheTrainercourse,May2003ClostridiumbotulinumtoxintrainingcollaborationswiththeORAU,CFSANStaffCollege,andtheCDC-MayandJuly2003(32stateandfederalparticipants)

RegionalCoordinationCenters(RCCs)-Overview

ConsistsofrepresentativesfromlaboratorycommunitiesStaffedbyFDA,USDA,andothers?Possibilityof“virtualhubs”TwoRCCsinitially;fiveRCCstotalFERNStructure:RegionalCoordinationCenters(RCCs)

RCCs-Responsibilities

IdentifyvolunteerlaboratoriesDeterminecapabilitiesandneedsoflaboratoriesEnsureadequatescreening,confirmatoryandforensiccapacityCoordinateresponseoflaboratoriesduringanemergencyCoordinatesurveillancesamplingprogramsCommunicatewithOperationsCenterCoordinatewithFERNsupportprogramsProvidequalityassuranceoversightIdentifyneedsandconveytoOperationsCenterConductexercisesandcoordinatereportingofresultsCoordinatewithkeynon-laboratorystakeholdersFERNStructure:RCCsCollectionandStorageofFERNRelatedDataWemustfindawaytostoreandmaintaindatafromthisprojectincluding:SurveillancesampleanalysisresultsProficiencysampleanalysisresultsResultsfromanysamplescollectedduringanactualbioterrorismeventThedatacapturemechanismfortheFERNistheElectronicLaboratoryExchangeNetwork(eLEXNET)FoodLaboratoriesandtheNationalFoodSafetyandSecuritySystemAgriculturalproduction&processingStorage&transportofrawcommoditiesProcessing&manufacturingStorage&TransportofproductsConsumptionFoodservice&preparationWholesale&retaildistributionSupportingAgenciesandSystemsFoodTestingLaboratoriesFederalStateLocalEPAUSDACustomsCDCFDADoDPublicHealthAgricultureEnvironmentalLawEnforcementDOTVeterinaryDiagnosticInspectionImportsActivitiesResearchEducationAdverseEventsFirmandProductRegistrationQualityAssuranceClinicalConsumerProtectioneLEXNETOverviewWhatisit?Anintegrated,securesystemdesignedformultiplegovernmentagenciesinvolvedinfoodsafetyactivitiesThenecessaryinfrastructureforanearlywarningsystemthatidentifiespotentiallyhazardousfoodsandenableshealthofficialstoassessrisksandanalyzetrendsWhoisparticipating?Federallaboratories(USDA/FSIS,FDA,DepartmentofDefense-VETCOM)StatePublicHealth,AgricultureandVeterinaryDiagnosticLaboratoriesLocalLaboratories

eLEXNETDataAflatoxinB1,B2Listeriaspp. BacilluscereusSalmonellaspp.LasalocidVibriofluvialisCampylobacterspp.CampylobacterjejuniDecoquinateListeriamonocytogenesfromover55foodtestinglaboratories,includingFDA,USDA,DoDVETCOM,aswellasstateagriculture,environmental,andpublichealth…andmorethan40productindustrycategories:Cheese/cheeseproducts,Fishery/seafoodproducts,Fruit/fruitproducts…andover16,500importedproductstested.StaphylococcusaureusShigellaspp.SulfathiazoleVibrioparahaemolyticusEscherichiacoli(Typical)Escherichiacoli,Enterohemorrhagic(EHEC)PenicillinGProcainePenicillinGBenzathineChlortetracyclineeLEXNETprovidesstateswithunprecedented,freeaccesstofoodtestingdatafromUSDA,FDA,DoD,andstateandlocallaboratories.Over160,000sampletestrecordsareineLEXNET:eLEXNET’sGISReportingFunctionsReportParameters:SalmonellaCheese/CheeseProductsAllLaboratoriesAllStatesAugust2002topresentWhat’sHappeninginyourRegion?ListeriaintheCentralRegion(Illinois,Indiana,Michigan,Minnesota,Wisconsin)in2001NationalFoodLaboratoryDirectoryNationalFoodLaboratoryDirectory:MapviewresultsofState,LabFunctionsearch(drilldowntoFlorida)AnIntegratedNationalLaboratoryInfrastructureNAHLNITSystem:AnimalDiseaseTestResultseLEXNET:FoodPathogenTestResultsNationalAnimalHealthLaboratoryNetwork(NAHLN)FoodEmergencyResponseNetwork(FERN)LaboratoryCapabilityandCapacityProgramsSecureDataExchangeofLaboratoryTestResultsSharedSystemModulesMethodsRepositoryLaboratoryDirectoryHL7DataExchange

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