ThisapplicationissubmittedonbehalfoftheOhioDepartmentofAgricultureConsumerProtection Laboratory(ODA?CPL)forthecontinuationoftheFDAChemistryandMicrobiologyCooperative AgreementsfortheenhancementofFoodEmergencyResponseNetwork(FERN)LaboratoryTesting CapabilityandCapacity.TheapplicationcoversFERNMicrobiological(Track1)andFERNChemical (Track2)Applications. TheFERNMicrobiologicalApplicationaddressesthefollowingthreeareas:1)theuseofvarious standardizedculturalandbiochemicalanalyticalmethodsforthedetectionandidentificationof pathogensinfood,2)theuseofvariousstandardizedserologicalanalyticalmethodsforthe detectionandidentificationofpathogensinfood,and3)theuseofvariousstandardizedmolecular analyticalmethodsforthedetectionandidentificationofpathogensinfood. TheFERNChemicalApplicationaddressesthefollowingfourareas:1)theuseofGas Chromatography?MassSpectrometry(GC?MS)analysisforthescreeningandidentificationof poisons,toxicsubstances,andunknowncompoundsinfoods,2)theuseofLiquidChromatography? MassSpectrometry(LC?MS)analysisforthescreeningandidentificationofpoisons,toxic substances,andunknowncompoundsinfood,3)theuseofInductivelyCoupledPlasma?Mass Spectrometry(ICP?MS)analysisforthescreeningandidentificationofheavymetalsandtoxic elementsinfoods,and4)theuseofEnzyme?LinkedImmunosorbentAssay(ELISA)andother antibody?basedanalysesforthescreeningandidentificationofunknowntoxinsinfoods. Mr.YamirRosaandMr.JasonKongwillserveastheprincipalinvestigatorsforMicrobiologicaland Chemicalapplications,respectively.Theywillhaveresponsibilityforprojectmanagementincluding organizingandassigningtheteamofanalyststoensurerapidsampleanalysis,reviewingsupply purchases,andpreparingprojectstatusreportsasrequiredbyFERNNPO.Theywillalsohavethe responsibilityofprovidingtechnicaloversightincludingmethodvalidation,reviewingstandard operatingprocedures,approvingprotocolormethodologychangesandprovidingproblem?solving expertise.Dr.MohammedAminwillapprovetheprotocolSOPsforcompliancewithQuality Managementpracticesandwillreviewdataasappropriate.Dr.Byrumprovidesbudgetaryand facilityoversightfortheworkperformedunderthisagreement.Mr.Tanprovidesadvisoryand administrativesupportfortheLC?MSactivitiesperformedunderthisagreement.Dr.Tanieka Motley,Mr.RandyWilson,andMs.ChristieLightnerwillbefunctioningastheprimarychemistsfor GC?MS,LC?MS,andICP?MS,respectivelywhileMr.DavidWilliams,Dr.SaberAhmed,andMs. DuanitaBookerwillfunctionasback?upsforGS?MS,LC?MS,andICP?MS,respectively.Anyofthese chemistscanbeassignedtoperformELISAtests.Ms.ChristinaReedandMs.AngelaBarlowewill serveastheprimaryandsecondarymicrobiologist,respectively. TheQualityManual(ISO17025accredited)andmanagementpracticesprovideahighlevelof confidenceinthereliabilityofresultsforallexistingprograms.Thelaboratoryhasaprovenability toperformlargenumbersofchemicalandmicrobiologicalanalyseswithexcellentturn?around?time forreportingresults. TheODA?CPLhasahistoryofactiveparticipationinnationalfoodsafetysurveillanceprogramsand intheinvestigationofsignificantchemicalandmicrobiologicalemergenciesintheUnitedStates. TheODA?CPLlaboratorieshaveanexcellentinventoryofrelevantinstrumentsandequipmentthat couldalsobeutilizedduringfoodemergencyconditionsorinthecaseoflargescaletestingneeds.
