The Association of Public Health Laboratories

BiomoniToring AnAlysis of HumAn ExposurE to CHEmiCAls

UnmeT needs• Provide$25millioninFY2010tofundCDC’s

NationalBiomonitoringProgram> $15Mtofundstatestobuildlaboratory

capacityandcapabilitytomonitorchemicalsinpeople.

> $10MtofundCDCtosupportstateprograms,developmethods,conductstudiesandissuereportsonmonitoringdiseaseandchemicalexposuresinpeople.

BAckgroUndEverydaywecomeincontactwiththousandsofchemicals.Thoughyouwouldnotknowinglybreatheinairpollutedwithsulfurdioxideordrinkwatercontainingarsenic,chemicalsintheenvironmentoftengounnoticed.Whilepoorairqualityhasbeenlinkedwithasthma,andasbestoswithcancer,manyotherchemicalexposure-healthrelationshipsarenotknown.Approximately100,000chemicalsarecurrentlyregisteredforuseintheUS,yetweknowverylittleabouttheireffectsonhumanhealth.

AspartofitsNationalBiomonitoringProgram,CDC’sEnvironmentalHealthLaboratoryhasmeasuredlevelsofchemicalsinpeopleforthelast30years.ThedataareusedtoassessexposuretoenvironmentalchemicalsintheUSpopulationandprovidevaluableinformationwhenanalyzedinconjunctionwithhealthoutcomedata.

CDCcurrentlyhasbiomonitoringdataavailableforhundredsofchemicalsincludingperchlorate,bisphenolA(BPA)cotinine(ameasureof

secondhandtobaccosmoke),flameretardants,certainpesticidesandothercomplexchemicals.

Biomonitoringdataarecriticalinassessingpeople’sexposuretochemicalsfollowingbothunintentionalandintentionalchemicaleventsbyidentifyingthechemicalagentanddeterminingwhichpeoplewereandwerenotexposed.Additionally,informationfromCDCaboutbackgroundlevelsofexposurecanbeusedasareferencetodeterminewhenpeoplehaveelevatedlevelsofchemicalsintheirbodies.OngoingmonitoringofexposedpopulationsbyCDCensurespeoplereceivepropercareandtreatmentandhelpsdecisionmakersdeterminewhichchemicalsneedregulation.

ProgrAmAPHLsupportsfundingfortheNationalBiomonitoringProgramatCDC.Currently,theNationalCenterforEnvironmentalHealthatCDCusesbiomonitoringtomeasurespecimensfromparticipantsintheNationalHealthandNutrition

CDC FUNDING Environmental Health Laboratory (Dollars in millions)

FY 2009 $7.5 (Enacted)

FY 2010 $25 (APHL Required Amount)

8515 Georgia Avenue suite 700 silver spring, mD 20910 | phone: 240.485.2745 | fax: 240.485.2700 | Web: www.aphl.org

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ExaminationSurvey.Newfundingwouldbeusedtoprovideadequatetechnicalassistanceandtrainingtostates,supportstudiestoinvestigatethehealthimpactsofchemicalexposuresanddeveloplaboratorymethodsthatarereadilytransferrabletostates.

Atthestatelevel,thisfundingwouldexpandstatelaboratories’abilitiestoconducttargetedpopulation-basedbiomonitoringstudies,upgradefacilitiesandequipmentandbolstertheirworkforcetoensureproficiencyinlaboratorytechniques.

BiomoniToring And environmen-TAL PUBLic HeALTH TrAckingRatesofchronicdiseasessuchasallergies,asthma,obesity,diabetes,heartdiseaseandmetabolicsyndromeareallontheriseintheUS.Althoughtherearemanytheorieswithregardtocause,therearenodefinitiveanswersexplainingthesealarmingrates.Pastresearchhaslinkedsomeenvironmentalexposureswithspecificdiseases,suchasbenzeneexposuretoleukemia.However,muchworkremainstodeterminewhetherornotexposuretocertainchemicals,suchasflameretardants,causesillnessordisease.

TheEnvironmentalPublicHealthTracking

(EPHT)Networkwillallowexistingenvironmentalhazard,exposureanddiseasetrackingsystemstobelinkedtogether.Biomonitoringisessentialtosuchlinkagessinceitisthemostaccuratemethodofdetermininghumanexposuretoenvironmentalhazardsandisabetterwaytoassesstheimpactofanenvironmentalhazardonhumanhealth.

StatelaboratoriesshouldplayanimportantroleintheEPHTNetwork.TheConnecticutEPHTProgram,forexample,isworkingcloselywiththestate’spublichealthlaboratory,theMaineHealthandEnvironmentalTestingLaboratoryandtheVermontDepartmentofHealthLaboratorytoexamineumbilicalcordbloodfromnewbornsformercury,lead,cadmiumandrelatedbiomarkers.

Althoughsomestateshavemadetremendousstridesinbiomonitoring,currentlytherearenosystemsthatexistatthestateornationalleveltotrackmanyoftheexposuresandhealtheffectsthatmayberelatedtoenvironmentalhazards.

APHLsupportstheexpansionoftheEnvironmentalPublicHealthTrackingprogramtolinkenvironmentaldatawithbiomonitoringandhealthdatainallstates.Fundingshouldincreasethenumberofstatelaboratoriesdoingbiomonitoringanddeveloptheirabilitytosharedataelectronicallywithotheragencies.

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The Association of Public Health Laboratories

newBorn screening promotinG tHE HEAltH of AmEriCA’s futurE

UnmeT needs• FundtheprogramsauthorizedintheNewborn

ScreeningSavesLivesActof2007(S.1858/H.R.3825)tobuildthenecessaryinfrastructureandworkforceneededforeducation,outreach,follow-upcare,laboratoryqualityassuranceandcontingencyplanning.

• Provide$10milliontotheCDCEnvironmentalHealthLaboratory’sNewbornScreeningQualityAssuranceProgramtoensurethatlaboratorytestsusedtoscreennewbornsarehighqualityandthatnewonesaredevelopedconstantly.

BAckgroUndNewbornscreeningisavitalresponsibilitywithprofoundandlifelongconsequencesforthethousandsofinfantsdiagnosedeachyearwithheritableandgeneticconditions,suchassicklecellanemiaandcysticfibrosis.Inmanycases,earlyinterventioncanmeanthedifferencebetweenrelativehealthandsevereimpairment…orevenbetweenlifeanddeath.

APHLanditsmembersareacutelyawareoftheimportanceofnewbornscreening(NBS)andtheelementsofahigh-qualityscreeningprogram.StatepublichealthlaboratoriesareaccountablefortheNBStestresultsof97%ofallbabiesbornintheUnitedStates—morethan4millionbabieseachyear.

Inthepastdecade,theenvironmentfornewbornscreeningunderwentdrasticchange.Ontheonehand,newtechnologiesandgeneticdiscoveriesledtoamajorexpansionoftheNBStestingpanel,creatinggreateropportunityfor

interventionandalsoapressingneedfortechnicaltraining.

Ontheotherhand,unforeseencatastrophes—includinghurricaneKatrina—demonstratedthevulnerabilityofstatenewbornscreeningprograms,whicharealmostalwayssingle-siteoperations.

Oneofthemajormilestoneinnewbornscreeninglastyearwasthepassingofthe“NewbornScreeningSavesLivesActof2007,”whichwassignedintopubliclawbyPresidentBushonApril24,2008,withoutanyappropriatedfunds.

Newbornscreeningisanessential,life-savingandeffectivepreventivepublichealthprogramforearlyidentificationofmedicalconditionsthatcanleadtocatastrophichealthproblems.ItidentifiesthousandsofbabiesbornintheUSeachyearwithageneticormetabolicdisorder.Thecostoftheseconditionsifleftuntreatedisenormous,bothintermsofhumansufferingandineconomicterms.

Worldwide,CDC’sNewbornScreeningQualityAssuranceProgramLaboratoryistheonly

CDC FUNDING Environmental Health Laboratory (Dollars in millions)

FY 2009 $8 (Enacted)

FY 2010 $10 (APHL Required Amount)

8515 Georgia Avenue suite 700 silver spring, mD 20910 | phone: 240.485.2745 | fax: 240.485.2700 | www.aphl.org

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newBorn screening promotinG tHE HEAltH of AmEriCA’s futurE

comprehensivesourceforensuringtheaccuracyofnewbornscreeningtests.FundingtheNewbornScreeningQualityAssuranceProgramat$8millionwillallowfor:1)Theresearchanddevelopmentofnew

laboratoryscreeningmethodsthatexpandthenumberofdisordersbabiescanbescreenedfor.

2)Population-basedpilottestingforconditions(e.g.,SevereCombinedImmuneDeficiency,PompeDisease,MetachromaticLeukodystrophy,etc.)notpresentlyincludedintestpanels.

3)Theprovisionoftechnicalassistanceandtechnologytransfertostatenewbornscreeninglaboratories,particularlywithregardtopromisingandsophisticatedtechniquescapableofidentifyingahostofdisorderscurrentlynotdiagnosableinnewborns.

4)Thetestingofnewscreeningtoolstoensurethehighestpossibleanalyticvalidityandutility.

coLLABorATion wiTH sTATe And LocAL HeALTH dePArTmenTs Duringthepastseveralyears,stateshave

experiencednewbornscreeningserviceinterruptionsduetobothnaturaldisastersandmanufacturerinabilitytoprovidetestingmaterials.Contingencyplanningisneededtolessentheeffectofdisastersthatinvolvenewbornscreeningprogramoperations.APHLcontinuestosupportthefundingfornewbornscreeningcontingencyplanningactivitiesthatwereoutlinedintheNewbornScreeningSavesLivesActtoensuretheavailabilityofnewbornscreeningduringanemergency.

oTHer criTicAL FUncTionsTheNewbornScreeningQualityAssuranceProgramLaboratoryatCDC:• Trainsstatelaboratoriansonthelatest

technologiesandprovidesproficiencystandardsfornewmaterials.

• Supportsstatelaboratoriesduringnewbornscreeningemergencysituations,suchastheaftermathofhurricanesKatrinaandRita.

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The Association of Public Health Laboratories

LABorATories mUsT Be ABLe To TrAnsmiTtEst AnD rEsult DAtA ElECtroniCAlly

UnmeT needs• Provide$112millioninannualCDCfundingfor

publichealthinformaticsinitiatives.• Provide$200millionannuallytodirectly

impactthestateandlocallaboratories’abilitytodevelopanddeployElectronicLaboratoryMessagingcapability.

• Increaselong-termfundingtostateandlocalpublichealthlaboratoriestoensurepurchaseandmaintenanceofastandards-compliant,interoperablelaboratoryinformationsystem.

• IncreasefundingfortheCDC’sNationalCenterforPublicHealthInformaticstosupportstateandfederaleffortsforelectronicdataexchange.

• Providefundingtosupportcommunity-buildingandcollaborationinitiativesamongallnationally-organizedpublichealthlaboratorynetworks.

BAckgroUndPublichealthlaboratoriesarekeyprovidersofpopulation-baseddiseasedatathatcanbeusedtoprotectthehealthofallAmericans.Theyprovidethemeanstorecognizeandalertofficialstooutbreaksofnewly-emergentandrecurrentdiseasebyservingastestingsitesforprivatephysicians,hospitalsandclinics,aswellasservingasadirectinterfacebetweenstateandfederalepidemiologists.Publichealthlaboratoriessafeguardentirecommunities.

Withouttheabilitytomanagelaboratorydatathemselves,labscannotdisseminateinformationtimelyandaccuratelytothoseresponsibleformanaging,controllingand

respondingtoanevent.Weneedsustainedfundingtoensureournation’slaboratorieshaveaccesstotechnologically-advancedinformationsystemsintimesofcrisis.

ALaboratoryInformationManagementSystem(LIMS)isavitalcomponentofthelaboratoryandsupportsallofitsfunctions—fromspecimenprocessingthroughsubsequenttestingandtestresultreporting.However,aLIMSisonlyonecomponentofthedailyworkandfunctionsofthelaboratorytoproducediseasedata.Theothercomponentistheelectronicexchangeofthepatient’stestordersandtestresultsamongthelaboratoryanditsprivate,local,stateandfederalpartners,whichisknownasElectronicLaboratoryMessaging(ELM).Toimplementonewithouttheotherwouldbetoimplementamarginallyusefulsystem.

ELMwouldpromoterapidinformationdisseminationandmitigationofexposure.Testordersandresultscannolongerbeinefficientlyreportedbytelephone,faxand

CDC FUNDING (Dollars in millions)

Public Health Informatics

FY 2009 $70 (Enacted)

FY 2010 $112 (APHL Required Amount) (with $32 million for public health laboratory data handling)

8515 Georgia Avenue suite 700 silver spring, mD 20910 | phone: 240.485.2745 | fax: 240.485.2700 | www.aphl.org

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email.Improvementsinhealthinformationtechnologymustincludethelaboratoriesthatperformtestingofpublichealthsignificance.

Virtuallyeverygovernmentagencyhascreatedaninformationnetworkwithinthepastfiveyearstotryandsupportweb-basedexchangeoflaboratorydata.Theproblemisthattheseeffortshavenotbeencoordinated,noradequatelyfunded,resultinginthemultitudeofsiloed,inefficient,oftenhomegrownsystemswehavetoday.

ModernizingthesesystemsandenablinginteroperabilityisahugechallengethatAPHLisstrivingtomeet.ThePublicHealthLaboratoryInteroperabilityProject(PHLIP)isacollaborationamongpublichealthlaboratory

scientistsandITexpertsfromAPHLmemberlaboratoriesandtheCentersforDiseaseControlandPrevention.ThePHLIPteamisdefiningthenecessaryinfrastructureandexpertisethatapublichealthlaboratorymusthavetoenabletwo-wayelectronicdatatransmissionwithpublichealthandclinicalpartnersinarecognizedstandardformat.

AsdocumentedinarecentreportfromAnalyticServices,Inc.,apanelofsubjectmatterexpertsidentifiedafundinglevelof$200millionannuallyasessentialtomovingforwardinasignificantway.“Withoutthisfunding,thefullbreadthofpublichealthlaboratoryresponsibilitiescannotbemet.”1

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1ElectronicLaboratoryReportingConsensus-BuildingMeeting.“FrameworkforElectronicLaboratoryReporting:

RecommendationstoPolicymakers.AReportoftheElectronicLaboratoryReportingConsensus-BuildingMeeting,”(Arlington,

VA:AnalyticServices,November2007)8.

The Association of Public Health Laboratories

ensUring THe eArLy deTecTion of fooDbornE DisEAsEs

BAckgroUndWhilesignificant,therecentnationaloutbreaksofgastrointestinaldiseaseassociatedwithfreshpeppersandpeanutbutterthatcapturednationalattentionaremerelythebest-knownexamplesofafarmoreextensiveburden.Foodiscapableoftransmittingmorethan200knowndiseases,andin1999,theCentersforDiseaseControlandPrevention(CDC)estimatedthatfoodbornediseasecausedapproximately76millionillnessesannually,including5,000deathsintheUS.Inthemajorityofoutbreaks,thecausesoftheillnessesremainunidentified.Theimprovedpublichealthlaboratory(PHL)capabilitythatwouldresultfromenactmentofCongresswomanRosaDeLauro’sbill,H.R.875,wouldallowfoodsafetyexpertstolinkcasesofillnessesmorerapidly,identifyingcommoncausesearlierinanoutbreakandpotentiallylimitingexposures.Frenzen,etal.estimatedin2005thatthepreventionofasinglefatalcaseofhemolyticuremicsyndromeinapatientinfectedwithShigatoxin-producingE. colimaysave$6.2milliondollars.

PHLsformthebackboneoftheresponsebyprovidinginformationthatcanassistepidemiologistsandotherfoodsafetyofficialsintheirinvestigation.LaboratoriesrespondtofoodborneemergenciesbydetectingandidentifyingoutbreaksthroughnetworkssuchasPulseNet,thenationalmolecularsubtypingnetworkformedbyPHLsandCDC.Withoutthesenetworks,largenationaloutbreaks,includingthe2008pepperoutbreakandthe2008-09peanutbutteroutbreak,mightneverbedetected.As

anexample,duringthenationalE. coliO157:H7outbreakin1993thatwastheimpetusforthedevelopmentofPulseNet,ittook39daystodeterminegroundbeefpattiesservedatanationalrestaurantchainwerethesourceoftheillness.In2006,duringthenationaloutbreakofE. coliO157:H7linkedtofreshspinach,ittookonly14daysfromthefirstcaseonsetofillnessuntiltheproductwasrecallednationally,preventinganuntoldnumberofcasesofillnesses.

PHLsserveanumberoffoodsafetyfunctions:• Disease Surveillance and PulseNet.Through

PulseNet,PHLsroutinelyperformDNAfingerprintingoncommonfoodbornebacteriaandtransmitthosedataelectronicallytoanationaldatabase,allowingmemberlaboratoriestoidentifyrelatedbacterialstrainsacrossstatebordersinatimelymanner.PulseNetcontinuestoexpandinscopeandutilitybyengagingnewfederalpartnersandtargetingemergingfoodpathogens.

• Outbreak Testing.Whenanoutbreakrelatedtofoodconsumptionoccurs,PHLsreceive

CDC FUNDING Food Safety (Dollars in millions)

FY 2009 $28 (Enacted)

FY 2010 $37* (APHL Required Amount) (*additional $9 million necessary to improve

food safety measures at the state level)

)

8515 Georgia Avenue suite 700 silver spring, mD 20910 | phone: 240.485.2745 | fax: 240.485.2700 | www.aphl.org

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ensUring THe eArLy deTecTion of fooDbornE DisEAsEs

bothhumanandfoodsamplesfrompublichealthnursesorhealthinspectorsandanalyzethemtodeterminethechemicalorbiologicalcontaminant.PHLs’contributionsallowforhumanillnesstobelinkedtoafoodsourcebyinvestigators.Foodsafetyinitiativesmaythenbepromotedtohelppreventfutureillness.

• Confirmatory Testing.PHLsalsotestsamplestoconfirmtheresultsofclinicalandhospitallaboratories.Thisroutinetestingisimportanttomonitoringtheincidenceandtypeoffoodbornediseaseinthepopulation.

PHL UnmeT needsOvertheyears,PHLshavebroughttheirfoodsafetylaboratorycapacitytoahigherlevelbasedonAPHLrecommendations.Theseeffortshaveyieldedtangibleresults:thenationallaboratorycapacityforfoodtestinghasgrownstronger.However,notablegapsremain:• Personnel.Withoutsteadyfundingforqualified

personnel,statesmaylacktheabilitytousetheirresourcesfully.AccordingtoarecentAPHLsurvey,64%ofstateswouldliketohiremorestaffbutdonothavesufficientfunding.

• Training.PHLpersonneltrainedforavarietyoftestmethodologiesarethelynchpinforsurgecapacity.Theknowledgegapinconventionallaboratorymethodsisincreasing,andstatesneedsufficientresourcestoadequatelytrainstafftoperformclassicalmicrobiologicalandchemicaltestingonbothfoodandhumansamples.However,81%ofstatelaboratorieshavecitedinadequatefundingastheprimarybarrierthatrestrictsthemfromprovidingfoodsafetytrainingtostaff.

• Reagents/Equipment.Whilemostlaboratoriesuseorhaveaccesstohighlytechnicalequipmentandsoftwarecapableofrapidly

detectinganddifferentiatingstrainsoffoodbornepathogens,maintenanceoflaboratoryequipmentisverycostly.Inaddition,reagentcostsareplacingasignificantfinancialburdenonmanyoftheselaboratories.

• Food Chemistry.EveryPHLshouldhavethecapabilitytoperformfoodchemistrytestingtodetectthepresenceofenvironmentalcontaminants,naturaltoxinsandotherchemicalagentsinfood.However,theaveragePHLhasonly1.6FTEsthatroutinelyperformfoodchemistrytesting.

cdc Food sAFeTy UnmeT needs• PulseNet—toallowimmediatetestingof

samples,expandPulseNettobeabletodetectadditionalpathogens,toevaluateandimplementnext-generationlaboratorytestingmethods,toimprovediagnosticmethodsandtrainingandtosupportnationalfoodbornediseasesurveillanceefforts.

• Improvements in sample shipping—toprovidestatesfundingtocombatrisingcostsofshippingclinicalisolatesand/orspecimenstoPHLsandassuretimelysubmissionofsamplesfromhealthcareprovidersandclinicallaboratoriestoPHLsperformingsurveilllance.

• Calicivirus/Norovirus—toexpandthenumberofstatesthathavecapacityformolecularNorovirusdetectionandsequencing,trainlaboratoriansinNorovirussequencingmethodsandsequenceanalysis,improveNorovirustypingmethodsandsupportnationalCalicivirus/Norovirussurveillance.

• Parasitic activities—todevelopnewtechnologies todetectthepresenceoffoodborneparasites

suchasCyclospora cayetanensisandtoprovidemolecular,conventionalandtele-diagnostictoolstoPHLs.

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The Association of Public Health Laboratories

environmenTAL LABorATories protECtinG our WAtEr from ContAminAtion

UnmeT needs• Support$20millioninFY2010forEPA’s

HomelandSecurityLaboratoryProgramto:> Buildcapacityandworkforceinthestatesto

analyzeenvironmentalsamplesforchemical,biologicalandradiologicalthreats.

> Expandthenumberofstatelaboratoriesparticipatingintheenvironmentalresponselaboratorynetwork(ERLN).

> Developandvalidatemethodsfortransfertostates.

> Expandthestateradiologicalgrantprogram.• ProvideEPAwith$10milliontobuilda

nationwidelaboratorynetworktoprotectourdrinkingwater(WaterLaboratoryAlliance).

BAckgroUndEverydayourair,waterandsoilareunderattackfromthetensofthousandsofchemicalspouringintothem.Mostpeopledon’tthinktwiceabouttheairtheybreatheorthewatertheydrink;theydependonourgovernmenttokeepthemcleanandsafe.Toensurethatthisimportantinfrastructureisindeedsafe,wemustensurethatlaboratoriesconductingregulartestingmaintaincertainqualityrequirements.Unfortunately,asdocumentedinarecentGAOreport,thisisnotthecase.EPAmustaddresslaboratoryqualityissuesthroughanationalstateenvironmentallaboratoryaccreditationprogram.

Terroristattacksendangernotonlyhumanlifeandhealth,butalsothenationaleconomyduetotheneedforevacuationandlaterremediation

oftheaffectedenvironment.EPAisresponsibleforconductingtheenvironmentalsamplingthatfeedsintothedecision-makingprocessfollowinganincidentofnationalsignificanceinvolvingtheenvironment,aswellastheremediationofaffectedareas.Stateandlocallaboratories,however,aretypicallythefirstreceiversduringanincident;thereforeEPAmustcoordinatewithenvironmentallaboratoriesaroundthecountry.

HomeLAnd secUriTy LABorATory ProgrAmGovernmentallaboratoriesreceivewhitepowdersorothersamplesthatmaycontainradiological,biologicalorchemicalwarfareagentseveryday.Theselaboratoriestestunknownsamplestoidentifycontaminantsandassessdangers.

Themajorityofstateandlocalenvironmentallaboratories,however,lacktheproperresourcestoadequatelyrespondsuchevents.Theyneedfederalguidancesuchasvalidatedmethods,standardsandproficiencytestingprograms.

EPA LAboRAtoRY FUNDING (Dollars in millions)

FY 2009 $6.1 (Enacted)

FY 2010 $39.6 (APHL Required Amount) (additional $20 million for the ERLN and $10

million for Water Laboratory Alliance)

8515 Georgia Avenue suite 700 silver spring, mD 20910 | phone: 240.485.2745 | fax: 240.485.2700 | www.aphl.org

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Withoutthissupport,stateswillbedelayedintheirresponseorunabletorespondatall,puttingthelivesofmillionsindanger.

Tomeetthisneed,APHLrequestsfundingforEPAtoadvancethedevelopingEnvironmentalResponseLaboratoryNetwork.Thisnetworkshouldprovideamechanismforstateandfederalenvironmentallaboratoriestocollaborateandleveragecapabilities.TheERLNwillalsoprovideamechanismtofundstateenvironmentallaboratoriestoincreasecapacitytorespondtoemergenciesandensurehigh-qualityresultstosupportdecisionmaking.

rAdioLogicAL PrePAredness gAPsIfaterroristweretoattacktheUSwitharadiologicalagent,federalandstatelaboratorieswouldbeverylimitedintheirabilitytorespond.DuringanOctober2007CongressionalhearingonUSlaboratorycapacitytoeffectivelyrespondtoaradiologicalattack,experttestimoniesrevealedthatvalidatedmethodstotestclinicalspecimensinaradiologicalemergencyexistforonly6ofthe13highestpriorityradioisotopesmostlikelytobeusedinaterroristevent.Thescreeningof100,000clinicalsamplesforisotopes(forwhichvalidatedmethodsdoexist)wouldtakemorethanfouryears,whileanalysisofenvironmentalsamplescouldtakeaslongassixyearstocomplete.

Accordingtoa2007APHLsurvey,55%ofrespondingstateenvironmentallaboratories

havetheabilitytotestdrinkingwaterforthepresenceofradiation.Inalarge-scaleevent,theselaboratorieswouldbequicklyoverwhelmedduetothehighsamplecount.Thesameisprobablytrueforothersampletypes.

Fundingisneededtoenhancethecapabilityandcapacityofstateandlocalenvironmentalandradiochemistrylaboratoriesbyupgradingequipment,providingtrainingandbolsteringtheworkforce.

wATer LABorATory PrePArednessTwohundredandfiftymillionAmericansgettheirdrinkingwaterfrompublicwatersystems.AterroristattackonalargemunicipalwatersupplycouldendangerthelivesofmillionsofAmericans.

Duringaterroristincident,stateandlocallaboratorieswouldbehardpressedtoanalyzethethousandsofwatersamplesforcontaminants.Laboratoriesneedanetworkofotherlaboratoriestocallonforhelp;otherwise,decisionsaffectinglifeanddeathmaybedisastrouslydelayed.

EPAhasmanagedtopartiallymeetthisneedthroughtheWaterLaboratoryAlliance(WLA).DedicatedfundingshouldbedirectedtowardtheWLA’sDrinkingWaterLaboratoryResponsePreparednessProjectforcoordinationofstateenvironmentallaboratories’planningandforbuildingcapacityinthestatestoanalyzethreats(forexampleasdirectedbyHSPD-9).

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The Association of Public Health Laboratories

LAck oF FUnds JeoPArdizes DisEAsE DEtECtion

UnmeT needs• Enhancethenation’sabilitytorespondto

emergingdiseaseoutbreaksby:> IncreasingCDC’scapacitytotestsamples.> Developinganddeployingdiagnostictests

tostateandlocalpublichealthlaboratories(PHLs).

> ProvidingtechnicalassistanceandtrainingtostateandlocalPHLprofessionals.

• IncreasesupportfortheEpidemiologyand LaboratoryCapacityProgram,acriticalsourceof fundingandtechnicalassistanceforinfectious diseasedetectioninstatelaboratories,

providing:> Capacitytorespondtoemergingdiseases.> Geneticfingerprintingforfoodbornediseases

throughPulseNet,whichmakesrapiddetectionofoutbreaksoffoodborneillnesses(forexample,Salmonellacontaminationinpeanutbutter)possibletoexpeditepublichealthinterventions.

> Detectionofvirusesthatcauseseriousintestinaldistressinhumans.

> Laboratorydetectionofdrugresistantbacteria(suchasMRSA),virusesandparasites.

• Enhanceinfluenzapandemicpreparednessandexpandearlywarninglaboratorysurveillancewithyear-roundtestingtorapidlydetectvariationsofinfluenzaviruses,especiallythedeadlyavianinfluenzaviruses,inaccordancewiththeDepartmentofHealthandHumanServices’“FederalGuidancetoAssistStatesInImprovingState-LevelInfluenzaOperatingPlans.”Continuedadditionalfundswillenhance

moleculardetectioncapacityusingCDC’snewprotocolthatreceivedFDA510(k)clearance,provideneededreagents,allowforstaffrecruitmentandprovidetraining.

• Developandimplementelectroniclaboratorymessagingsystemsthatcantransferappropriatedataforbetterdiseasecontrol.

• Preparethenextgenerationoflaboratoryleadersthrougheducationandmanagementtrainingprograms.

• EnhancenationalcapacitytodetectandpreventoutbreaksofnewinfectiousdiseasesthroughtheEmergingInfectionsProgram.

CDC FUNDING (Dollars in millions)

Preparedness, Detection and Control of Infectious DiseasesFY 2009 $157 (Enacted)FY 2010 $167 (APHL Required Amount) (additional $10 million for responding to emerging infectious diseases)

Pandemic InfluenzaFY 2009 $156 (Enacted)FY 2010 $166 (APHL Required Amount) (additional $10 million for state and local surveillance capacity)

Vector-borne Diseases, including West Nile VirusFY 2009 $26 (Enacted)FY 2010 $46 (APHL Required Amount) (additional $20 million for surveillance and detection of vector-borne diseases, including West Nile Virus)

8515 Georgia Avenue suite 700 silver spring, mD 20910 | phone: 240.485.2745 | fax: 240.485.2700 | www.aphl.org

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LAck oF FUnds JeoPArdizes DisEAsE DEtECtion

PrePAredness, deTecTion And conTroL oF inFecTioUs diseAsesTheCDCInfectiousDiseasesControlProgramfundscriticallaboratoryimprovementsthatallowfederalandstateprogramstomaintainearlywarningdetectioncapabilitiesforknowndiseasesandprovidequickidentificationofunknowndiseases.Increasedfundingisessentialtopreserveexistingcapacity,enhancesurveillancefornewstrainsofinfluenzaandprovideimprovedresponsivenesstothegrowingproblemofemergingdiseases.ArecentoutbreakofchikungunyavirusinItalydemonstrateshowonepersoncanacquirethediseasewhiletravelingabroadandtransmitthevirustomosquitovectorsintheirhomecountry.Theinitialintroductionintothemosquitopopulationresultedin334suspectedcasesinageographicalregionthathadnotpreviouslybeenexposedtothedisease.LaboratorycapacityinItalywascriticaltoconfirminfectioninmorethan200people.

RecentdomesticinfectiousdiseasethreatsincludeCA-MRSAandotherantibiotic-resistantbacteria,Tamiflu-resistantandavianinfluenza,SARS,monkeypox,HepatitisA,bacterialmeningitis,WestNileVirus,malariaanddenguefever.Thethreatforpandemicinfluenzaisatanunprecedentedlevelduetohighlypathogenicavian(H5N1)influenzaco-circulatingwithhumaninfluenzainsettingswithhighriskofexposure(birdmarkets),resultingingreaterpotentialforadaptationtohumanhostsorre-assortmentwithcirculatinghumanviruses.Therehavebeenatleast360confirmedcasesofavianinfluenzaresultingin226deathsworldwide.Wemustalsobepreparedforanunexpectedstrainofinfluenzatoemergeasapandemicstrain.Arecommendationfromthe“FederalGuidancetoAssistStatesinImprovingState-LevelInfluenza

OperatingPlans”(http://www.pandemicflu.gov/news/guidance031108.pdf)hasidentified“PandemicIntervals,Triggers,andActions”toassiststatesandlocalsinupdatingtheirpandemicplans.Laboratorytestingtoconfirmintroductionandspreadofanovelstrainisacrucialcomponenttotriggerappropriatemitigationandcontrolstrategiesforeachinterval.

Overthepastfewyears,therehavebeenseverallarge,multi-stateoutbreaksofpertussis(whoopingcough),mumpsandmeasles,diseasesnowre-emerginginchildrenandadults.Inadditiontothehumanimpactofthesediseases,thereisatremendouseconomicimpact.EstimatesindicatethatinfectiousdiseaseshaveaneconomiccostintheUSofmorethan$120billioneachyear.Aninfluenzaoutbreakonthescaleof1918wouldcauseanestimatedonemilliondeathsintheUS.

vecTor-Borne diseAses, incLUding wesT niLe virUsFederalWestNileVirusfundingsupportssurveillancethatdeterminesthelevelofdiseaserisktopeopleandgetsthismessageouttoproviders,respondersandthepublictoallowforimplementationofappropriateinterventions.

Withthisfunding,manystatesarealsoabletoperformthesameactivitiesforothervirusesthatcauseencephalitis,whichisimportanttomonitorforoutbreaksofSt.LouisencephalitisorevendengueifitemergesintheUS.Proposedfundingreductionswillforcesomestatestochoosebetweenkeepinglaboratorystafftoperformtestsandthematerialsneededtoconductthosetests.Otherstatesmayberequiredtofundamentallychangethescopeoftheirtestingprogramsandreducetheinformationthatisnecessaryforsuccessfulinterventionstrategies—whichwillleadtoincreasedillnessinhumansandanimals.

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The Association of Public Health Laboratories

rEvitAlizinG DomEstiC Hiv/Aids eFForTs

UnmeT needs• ProvideHIV/AIDSfundingconsistentwiththe

CentersforDiseaseControlandPrevention(CDC)ProfessionalJudgmentBudget.

• SupportHIVsurveillancesothatfundscanbeallocatedwheretheyareneededmost.

• ProvideresourcessothatnewHIVdiagnosticandscreeningtechnologiescanbevalidatedandimplementedinpublichealthlaboratories.

• EnablelaboratoriestodetectHIVinfectionsintheirearliest(andmostinfectious)stagesbysupportingthenewestandmostadvancedtestingtechnologies,includingnucleicacidamplificationtestingandfourth-generationimmunoassays.

• ImprovelaboratorycapacitytomonitorandconfirmHIV-2infections.

• EvaluatethenewlyproposedalternativeHIVtestingalgorithmstoimprovethespeed,accuracyandefficiencyofHIVdiagnosisandsurveillance.

• FacilitateHIVdiseasemanagementbyenablinglaboratoriestoconductviralloadtesting,genotypingandantiretroviralresistancemonitoring.

BAckgroUndMorethan25yearsafterthefirstdocumentedcases,HIV/AIDScontinuestobeamajorpublichealthburdenintheUnitedStates.TherearemorethanonemillionpeoplelivingwithHIVin

theUStoday,andthisnumberisgrowing.WhileHIVaffectsallracial,socio-economic,regionalandagegroups,African-Americans,Latinosandmenwhohavesexwithmenhavebeendisproportionatelyaffectedbytheepidemic.

RecentadvancesinsurveillancetechnologyhaveallowedCDCtomoreaccuratelyestimatetheincidence(ornumberofannualnewinfections)ofHIV.Therewere56,300newHIVinfectionsin2006,40%greaterthanthe40,000thatwaspreviouslyestimated.CDCestimatesthatforevery100peoplelivingwithHIV,fivenewinfectionswilloccurperyear.EarlydiagnosisofHIViscrucialtolimitingthenumberofnewinfections.

CDChasdevelopedanambitiousplantocombatHIV/AIDSintheUS.By2020,theyhopetoreducetheHIVtransmissionratefrom5%to2.5%andtoreducetheproportionofinfectedindividualswhoareunawareoftheirstatus.Currentdatashowthatin2006,21%ofHIV-infectedindividuals(more

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CDC FUNDING Preparedness (Dollars in millions)

FY 2009 $691 (Enacted)

FY 2010 $1,578 (APHL Required Amount)

rEvitAlizinG DomEstiC Hiv/Aids eFForTs

than200,000people)don’tknowtheyareHIVpositive,andCDCwantsthisnumbercutinhalf.

Toachievethesegoals,CDCdevelopedaprofessionaljudgmentbudgetthatoutlinedtheidealapproachtofightingHIV/AIDSintheUS.AvitalpartofthisplanincludesscalingupHIVtestinginitiatives,improvingHIVmonitoringsystemsanddevelopingnewtoolstoaggressivelyfightHIV/AIDS.Stateandlocalpublichealthlaboratorieswouldplayakeyroleinthisinitiative,andanincreaseinlaboratoryresourceswouldbenecessaryinorderforittosucceed.

Currently,publichealthlaboratoriesprovideservicescrucialtothediagnosisofHIVinfections.PublichealthlaboratoriesserveasreferralandreferencelaboratoriesforHIVtestingandsupporttheworkofotherpublicandprivatesectorlaboratories.TheselaboratoriesareinstrumentalinconductingdiseasesurveillanceandprovidethedatanecessarytomonitortrendsinHIVinfection.WiththeincreasingnumberofpeoplelivingwithHIV/AIDSinthepublichealthcaresystem,publichealthlaboratorieswillhaveanincreasingroleindiseasemanagementaswell.Developingthiscapacitybyprovidingviralloadtesting,antiretroviralresistancemonitoringandCD4/CD8cellcounts,willimprovebothpatientcareandpublichealthsurveillance.HIV-2,alesscommon

butcloselyrelatedstrainofHIV,posesanotherchallengetopublichealthlaboratories.Atpresent,thereislimitedcapacityfortheconfirmationandmanagementofHIV-2infections.InfectionsbythisstrainaremostlylimitedtoWestAfrica,butthisgapmustbeaddressedtoimprovepublichealthlaboratorypreparedness.

Inrecentyears,newtechnologieshavearisenthathavegreatlyimprovedthespeedandaccuracyofHIVscreeninganddiagnosis.MostHIVtestsrelyonthedetectionofantibodiesagainstHIV,whichcansometimestakemonthstodevelop.Unfortunately,itisduringthissameperiodthatHIV-infectedindividualsaremostinfectious.Newtechnology,suchasnucleicacidamplificationtestsandfourth-generationimmunoassaysarecapableofdetectinginfectionmuchearlierthanwaspreviouslypossibleandcouldbecrucialinbreakingthetransmissioncycle.WhilethesetestsaremoreexpensivethantraditionalHIVtests,theirabilitytodetectinfectionatthemosttransmissiblestagecouldsignificantlyimproveourabilitytopreventnewinfections.

APHLhasbeenworkingwithCDCandstateandlocalpublichealthlaboratoriestodevelopnewtestingalgorithmsthatincorporatethemostadvancedHIVdiagnostictools.

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The Association of Public Health Laboratories

TUBercULosis A sErious rE-EmErGinG tHrEAt

UnmeT needs• Providefederalfundingof$210million

asauthorizedinPublicLaw110-392.HHSSecretary’sAdvisoryCouncilfortheEliminationofTuberculosishasrecommended$252.4milliontomeettheCDCgoaloftuberculosis(TB)eliminationintheUS.> Developgovernment/privatepartnerships

designedtoencouragethedevelopmentofnewtuberculosisassays.

• Increasefundingforlaboratoriestoimplementnewandexistingdiagnosticteststhatcanidentifytuberculosisandscreenfordrugresistance.

• StandardizedrugsusceptibilitytestingmethodsintheUSforfirst-andsecond-linedrugsusedtotreatTBpatientstoimproveclinicaloutcome.

• ProvidefundingforCDCtoconductan assessmentoflaboratorytuberculosistesting capacity.• Developaplanofactionthatwilladdress

extensivelydrugresistanttuberculosis(XDR-TB)topreventitfrominvadingtheUS.

• DirectCDCtodevelopastrategicplanforimplementingandmaintainingasystemsapproachtoTBcontrolthatincludeslaboratorysystems.

• AssessthetruecostsofprovidingTBlaboratoryservicesbecausethecosttoidentifyindividualcasesrisesasthenumberofcasesdeclinesandthecostofserviceswillvaryfromonejurisdictiontoanother.

• Developrecommendedtestingmethodsfordifferentpatientpopulations,aswellas

guidelinestohelpjurisdictionsselecttheappropriatelevelofservice.

• Improvelaboratorystaffproficiencyincomplextuberculosistestingproceduresinlightoffewerspecimensbeingtestedinrelationtothedeclineintuberculosis.

• Trainnewlaboratorystaffintuberculosistestingproceduresinlightofarapidlyagingworkforce.

BAckgroUndTuberculosisisaseriousre-emerginginfectiousdiseasethataffectsthelungsandrespiratorysystemaswellasotherorgansandcanleadtodeathifleftuntreated.Thisillnessistransmittedperson-to-personviatheairbycoughing,sneezingandeventalking.Tuberculosishasre-emergedasaco-infectionwithHumanImmunodeficiencyVirus(HIV)becauseHIVweakenstheimmunesystemandmakesthepatientmoresusceptibletoinfectionandsevereTBdisease.

Today,despiteanoveralldeclineincases,tuberculosiscontinuestoincursignificantsocial,publichealthandeconomiccostsintheUS.

CDC FUNDED (Dollars in millions)

FY 2009 $143 (Enacted)

FY 2010 $210 (APHL Required Amount)

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TUBercULosis A sErious rE-EmErGinG tHrEAt

Approximatelyone-thirdoftheworld’spopulationislatentlyinfectedwiththebacteriumthatcausestuberculosis.Anestimated10millionto15millionUScitizenshavelatenttuberculosisinfection,andabout10%oftheseindividualswilldeveloptuberculosisatsomepointintheirlives.Approximately13,500newcasesoftuberculosisdiseasewerediagnosedin2007intheUS.Costlytuberculosisoutbreaksstilloccur,andmulti-drugresistanttuberculosiscontinuestospread.Nowthenationisfacinganewtuberculosisthreat,extensivelydrugresistanttuberculosis(XDR-TB),aformoftuberculosisthatisresistanttothetwomostimportantfirst-linedrugsandatleasttwoofthemostimportantsecond-linedrugsavailablefortreatment.XDR-TBisadeadlyformoftuberculosisthatcanbeincurable,especiallytopeoplewithHIV/AIDS,andisswellingtoepidemicproportionsinsouthernAfrica.AnumberoflaboratorieshavealreadyreportedthisdeadlynewformoftuberculosisintheUS.TheCDCprovisionallyestimatesthatthedirectmedicaltreatmentcostsofanXDR-TBpatient($132,000)areonaverage2.5timeshigherthanthoseofamulti-drugresistanttuberculosis(MDR-TB)patient($53,000)andmaybemuchhigherdependingonhospitalizationlengthandlocationoftreatment.Altogether,tuberculosis-relatedcostsapproach$1billioneachyearintheUS.

ToreachthegoaloftheeliminationoftuberculosisintheUS,improvementsinlaboratorytestingmustbemaintainedandtranslatedintoimprovementsinthetreatment,preventionandcontroloftuberculosis.Despiteadvancesinlaboratorymethods,lackofcoordinationfor

referralofspecimensandculturescontinuestoleadtounnecessarydelaysinlaboratorytesting,reportingandinitiationoftreatment.

Currentlyall50statepublichealthlaboratoriesperformsomeleveloftuberculosistestingandserveasreferralandreferencelaboratoriesforcultureidentificationandtuberculosisdrugsusceptibilitytestinginsupportofotherpublicandprivatesectorlaboratories.StatepublichealthlaboratorieshaveusedCDCfundingoveraperiodofmanyyearstocreatemodernlaboratorieswiththelatestdiagnosticequipmentapprovedfortuberculosisisolationandidentification,biosafetyequipmenttoprotectlaboratorystaffandpremises,personnelsufficienttomeettheneedforrapidlaboratoryconfirmationoftuberculosisandongoingstafftrainingintheuseofstate-of-the-artdiagnosticequipmentandrapidtestingprocedures.Aslaboratorieshavebecomebetterequippedandpersonnelbettertrained,federalfundshavebeenusedlesstoupgradetuberculosislaboratoriesandmoretomaintaincoretuberculosiscapabilitiesandinfrastructure.

Ofthe$140millionallocatedfortuberculosiscontrol,only$8milliongoestosupportingpublichealthlaboratorytesting.Thisnumberhasbeenstagnantat$8millionannuallysince1995.Withinflationfactoredin,thefundinghasexperienceda25%decreaseinrealdollars.Althoughitistemptingtothinkthatfundingcandecreaseinproportiontothedecreaseinthenumberoftuberculosiscases,belowacertainpointthisreasoningfallsapart,sinceabaseleveloffunding(inrealdollars)isnecessarytomaintainthetuberculosiscontrolinfrastructure.

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The Association of Public Health Laboratories

BioLogicAL PrePAredness must bE mAintAinED

UnmeT needs• EnsureCDCreceivesfundingcomparableto

theFY2005levelstoexpandprograms,developmethods,providetrainingandensureadequatestaffinglevelsatstateandlocalpublichealthlaboratoriesthataremembersoftheLaboratoryResponseNetwork(LRN)forbiological,chemicalandradiologicalterrorismpreparedness.

• IncreasedirectfundingforCDCtosupportarapidlydeployablereagentstockpilefortheLRNlaboratoriestoassurethatrapidandaccuratelaboratorytestingcanoccur.

• Buildsafeandsecurefacilitiesforintaketriageandtestingofunknownsamplesandprovidenationalguidelinesonthetriagingofunknownsamples.

• Developandimprovemethodsforrapidconfirmationofbioterrorism,chemicalandradiologicalthreatagentsinhuman,food,animalandenvironmentalsamples.

• Expandpublichealthlaboratoryoutreach,trainingandcoordinationwithhospital,veterinary,foodandenvironmentallaboratorieswhereterrorismagentsmayfirstbedetected.

• Provideaminimumof$10millionfundingtotheDHSOfficeofHealthAffairstocoordinatewithotherfederalagenciesandpartnerstodeveloparobustvalidationprocessforhand-heldassaysandotherfieldassays.

Continuedfederalfundingatappropriatelevelswillpreservethestateandlocalcapacitythathas

beenbuilt,whichallowslaboratoriesto:• Respondrapidlyandeffectivelytoaterrorist

eventorpublichealthemergency.• Purchasenewinstrumentation,adoptnew

technologiesanddevelopelectronicdatamessaging.

• Recruitandretainhighlyskilledlaboratorypersonnel.

• Maintainoutreachprogramstohospitalandclinicallaboratoriesandfirstresponders.

• Assureacoordinatedresponseeffortwithfederalpartners.

BAckgroUndFormedin1999bytheCentersforDiseaseControlandPrevention(CDC),theFederalBureauofInvestigation(FBI)andAPHL,theLRNisthenation’spremiersystemforidentifying,testingandcharacterizingpotentialagentsofbiologicalandchemicalterrorism.Stateandlocalpublichealthlaboratoriescompriseapproximately70%of

CDC FUNDING (Dollars in millions)

FY 2009 $700 (Enacted)

FY 2010 $919 (APHL Required Amount) (plus $20 million for EPA’s ERLN)

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BioLogicAL PrePAredness must bE mAintAinED

the165LRNBiologicalReferenceLaboratoriesandalmost100%oftheLRNChemicalLaboratories.Theselaboratoriesproducehigh-confidencetestresultsthatarethebasisforthreatanalysisandinterventionbybothpublichealthandlawenforcementauthorities.

TheLRNforBiologicalTerrorismpreparednessisorganizedasathree-tieredpyramid.Atthefoundationarethousandsofsentinelclinicallaboratories,whichperforminitialscreeningforpotentialpathogens.Whensentinelclinicallaboratoriescannotruleoutthepresenceofabiologicalterrorismagent,theyreferspecimensandisolatestoanLRNreferencelaboratory.Morethan160stateandlocalpublichealth,military,international,veterinary,agriculture,foodandwatertestinglaboratoriesserveasreferencelaboratories,performingcomplexanalysesandprovidingsupporttolawenforcementforthreatinvestigations.InadditiontolaboratorieslocatedintheUS,facilitieslocatedinAustralia,CanadaandtheUnitedKingdomserveasreferencelaboratories.Attheapexofthepyramidarenationallaboratories,suchasthoseattheCDCandtheDepartmentofDefense(DoD).Theselaboratoriestestandcharacterizesamplesthatposechallengesbeyondthecapabilitiesofreferencelaboratories,andprovidesupportforotherLRNmembersduringaseriousoutbreakorterroristevent.

In2001,theLRNperformedmorethan1millionanthraxtests.Sincethen,publichealthlaboratorieshavebeenregularlytestingsamplestoruleoutbioterrorisminsupportoflawenforcementandpublichealthagencies.Ina12-monthperiod(CDCPublicHealthEmergencyPreparednessCooperativeAgreementFY07),statepublichealthlaboratoriesreceivedmorethan

5,000unknownsamplesandperformedmorethan9,000testslookingforsuspectedterrorismagents.

BioLogicAL TerrorismThepublichealthlaboratoriesof50statesandtheDistrictofColumbia(DC)receivedabout$49millionforbioterrorismpreparednessinFY2007,whichisapproximately$24millionlessthanFY05fundingand$56millionlessthanFY02funding.

Duetothesefundingissues,severalproblemsplaguepublichealthlaboratories,includingseverestaffingshortages,lackofintegratedlaboratoryinformationmanagementsystemsforelectronicdatamessagingandaging,non-securefacilities.Despitetheseconstraints,expectationsofLRNpublichealthlaboratoriescontinuetoexpandduetotheimplementationofnewtechnologies;additionofnewtestsforadditionalagentsofbioterrorismandotherinfectiousdiseasethreats;increasedcoordinationwithfood,veterinaryandenvironmentallaboratories;andanamplifieddemandoftrainingforsentinelclinicalandhospitallaboratorypartners.

LRNpublichealthlaboratoriescontinuetoreachouttosentinellaboratoriesandhavetrainedthousandsoflaboratorians.FromAugust2007toAugust2008,statepublichealthlaboratoriessponsoredsentinel(clinical)laboratorytrainingandoffered233rule-outtestingclassestomorethan2,100laboratorians;about250packagingandshippingclassestomorethan3,500laboratorians;about530biosafetyguidelinesclassestoapproximately2,300laboratories;andmorethan250classesonbroadlaboratorypracticestomorethan2,700laboratorians.Increasedfundingforstaffatthestatepublichealthlaboratoriesisneededtoensurecontinuationofthesecriticaltrainingclasses.

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The Association of Public Health Laboratories

cHemicAL PrePAredness WE’rE STILL not rEADy

UnmeT needs• DirectCDCtodedicatefundingforallLaboratory

ResponseNetworklaboratoriesintheirPublicHealthEmergencyPreparednesscooperativeagreement.

• RestorefundingtoCDC’schemicalterrorismlaboratorytoFY2007levelstosupportmethodtransfertostatesfordrugsofabuse,incapacitatingagentsandothertoxicants.

• Provide$10milliontofullyfundall10Level1chemicalterrorismlaboratoriestoensureournation’sabilitytorespondtolarge-scalechemicalevents.

BAckgroUndWhenmostpeoplethinkofterrorismevents,theythinkaboutbioterrorism,suchastheanthraxattacksof2001.However,chemicalterrorismposesanequallysignificantthreat,andtherearetensofthousandsoftoxicchemicalsthatcouldfallintothewronghands.AlthoughthecreationofthechemicalsideoftheLaboratoryResponseNetwork(with46publichealthlaboratoriesandCDC)in2003dramaticallyincreasedcapabilityandcapacitytorespondtochemicalterrorismincidents,manygapsandchallengesremaintoday.Akeybarrierhasbeenthesteadydownwardspiraloffunding.Ofthe$746millionenactedforpreparednessactivitiesin2008,onlyabout$24millionofthiswasdirectedtopublichealthlaboratoriesforchemicalterrorismpreparednessactivities.Ifthiscontinues,millions

ofdollarsoftheinvestmentsmadeintheseuniquelaboratorieswillbewastedastheinstrumentssitidlebecausethereisnotrainedstafftooperatethem.Inaddition,wewillfallshortinmeetingcriticalchemicalpreparednessneeds.

Throughdeterminationanddedication,oftendespitethelackofdedicatedfunding,chemicallaboratorieshavemadeprogress:• In2003,onlyeightstatelaboratoriesreported

havingachemicalterrorismresponseplaninplace.By2006,35reportedhavingawrittenplanforachemicalincident.

• Publichealthlaboratoriesnotonlydraftedplansforachemicalincident,buttheyalsopracticedforone.In2007,statepublichealthlaboratoriesconductedonaverage3.5drillsorexercisesforchemicalterrorismpreparedness.In2008,CDCandthe10Level1surgecapacitylaboratoriesconductedanexerciseinvolvingtherapidanalysisof5,000samples,thesamenumberastherewerepatientsintheMarch10,1995,Tokyo

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PREPAREDNESS (Dollars in millions)

FY 2009 $700 (Enacted)

FY 2010 $919 (APHL Required Amount)

subwaySarinattack.Morethanhalf(56%)oflaboratorieswithacontinuityofoperationsplanincludedchemicalthreatpreparednessactivitiesinthisplan.

• Moststates(31)reportedhavingafull-timestaffpersontocoordinatethechemicalterrorismlaboratoryin2007,althoughthisisarequirementofthePublicHealthEmergencyPreparednesscooperativeagreement.

• In2007,92%ofstatepublichealthlaboratorieswerecapableofconductingsomechemicalthreatagentanalysesonclinicalsamplesusingstandardizedmethodsandtrained,dedicatedstaff,anincreasefrom10%in2003.

However,majorgapsstillexist:• Workforceshortagespersist.In2003,fivestates

hadchemistsdedicatedtochemicalemergencyresponseonstaff.In2007,46laboratorieshaddedicatedanalystsbutonlyhadanaverageof2.8full-timechemistsonstaff.Laboratorieswithoneortwochemistswouldnotbeabletomaintain24/7response,whichisoftenneededduringalargeevent.

• Although36SPHLsreportedthattheyprovidedtrainingtofirstrespondersin2007,laboratoriesreportalackofstaffandinstrumentationtoprovidesufficienttrainingandoutreach.Furthermore,thereisstillalackofnationalguidanceforthesetrainings.

• Laboratoriesreceivedmorethan5,200threatsamplesin2007andtestedmorethan1,800forachemicalthreat.Ofthe5,200,morethan1,200wereenvironmentalsamplesthatcouldhavecontainedachemicalorradiologicalthreat.

cHemicAL LABorATory resPonse neTworkTheChemicalLaboratoryResponseNetwork(LRN-C)isanationwidenetworkoffederal,stateandlocallaboratoriescapableofconfirmingthepresenceofchemicalterrorismagentsandothertoxicsubstancesinclinicalsamples(bloodandurine).Theselaboratorieshavedesignated“levels”thatcorrelatewiththeircapacitytoperformcertaintasksduringemergencyevents.

Chemicallaboratoriesinthisnetworkhavemadegreatstridesinpreparednesssincetheyfirstreceivedfundingin2003.However,bothCDCandthestatesarenolongerreceivingthenecessaryfundingtosustainthelevelofpreparednesstheyhaveworkedsohardtobuild.CDChasandiscurrentlydevelopingmethodsthatwillenablelaboratoriestotestmoresamplesinashortertime.However,thesemethodsrequireexpertise,trainingcoursesandlaboratorians’time,allofwhichrequireadequatefunding.

In2006,fivenewlaboratoriesweredesignatedasLevel1,whichisthelevelcapableofprovidingsurgecapacitytoCDCformorerapiddetectionofthemostdangerouschemicalagents.StudiesbytheIntegratedConsortiumofLaboratoryNetworkshaveshownthatournationneedsatleast10Level1laboratoriesinordertohandlethenumberofsamplesanticipatedduringachemicaleventofnationalsignificance.Yet,thefundingforthesenationalassetshasnotincreasedtoreflecttheincreasednumberoflaboratoriesandtheincreasednumberofsamplesthatareprojectedtobeneededtorespondtoamajorincident.

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The Association of Public Health Laboratories

rAdioLogicAL PrePAredness

UnmeT needs• Provide$10milliontoCDC,asrequestedby

theFY09proposedPresidentialbudget,tobuildaradiologicalcomponentoftheLaboratoryResponseNetwork.

• DirectCDCtoincludefundinginthePublicHealthEmergencyPreparednessgrantforradiochemistryactivities.

• ProvideadditionalfundingtoCDCtodevelopmethodsandtoprovidetechnologytransfertostateandlocallaboratorians.

Sincethe1950s,thethreatofaradiologicaleventevokesfearinheartsaroundtheworld.However,radiologicalpreparednessinlaboratorieshaslongbeenignored.ItwasnotuntilarecenthearingintheHouseCommitteeonScienceandTechnologythatmostpeopleunderstoodthereisacompletelackofcapacitytoscreenandtestforradionuclides.Duringthishearing,membersofCongressexpressedconcernaboutthelackofreadinessforaradiologicalevent.However,theyhaveyettoappropriatefundingtoimprovethis.

CDCisdevelopinguniquelaboratorymeasurementsinurinetodeterminewhetherpeoplehaveradionuclidesintheirbodiesand,ifso,howmuch.Thisinformationwillidentifyexposedindividuals,assesstheirhealthriskanddetermineeffectivetreatment.Withtheexceptionofafewradionuclides,itisnotpossibletodeterminethisexposurewithoutthesenewtechniquesbeingdevelopedatCDC.

CDC’sdevelopmentoftheUrineRadionuclideScreen(URS)willneedthisforidentifyingwhichradionuclideapersonisexposedtoandthe

levelofexposureorcontamination.TheURSistargetingmorethan20high-priorityradionuclidesonthebasisoflikelyradiologicterrorismscenarios.Currently,CDCisworkingtocompletetheURS,whichwouldprovideresultswithin24hoursofreceivingasample.

Almostallstatepublichealthlaboratorieslackthecapabilitytotesthumansamplesforthepresenceofradionuclides.Thisisduetoalackoffundingandtheworkforceshortageaffectingtheradiochemistryfield.Fewnewscientistsarebeingtrainedonradiologicalanalyticalmethods.Mostlaboratoriesdonothavesupportforaradiologicalprogramand,therefore,therearefewjobsforfutureradio-analyticalscientists.• Onaverage,statepublichealthlaboratories

havefewerthantwotrainedstaffforradiologicalactivities.

• Nostatepublichealthlaboratoryhadhigh-resolutionequipmentforradiologicalanalysesandonlyfivelaboratorieshaveonethatcouldbeusedformeasuringradionuclidesinFiscalYear2007.

CDC FUNDING Preparedness (Dollars in millions)

FY 2009 $0 (Enacted)

FY 2010 $10 (APHL Required Amount)

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rAdioLogicAL PrePAredness

• Only15statepublichealthlaboratoriescanmeasurehumanspecimensforradionuclides.Seventy-fivepercentofthoselaboratoriescanonlymeasureforoneradionuclide(Uranium).

TherecentassassinationofAlexanderLitvinenkoillustratesjusthowquicklyaradiationeventcanescalate.Onlyoneperson,Litvinenko,wastargeted,buttensofthousandsofpeoplewerepotentiallyexposed.Morethan1,000peopleneededtobetested,andseveralbuildingsintheUKwillbesealedforthenextfiveyears,duetocontamination.

rAdioLogicAL LABorATory resPonse neTworkAfteraradiologicalevent,therewillbeamyriadofquestions:whowasexposed,towhatsubstanceandtowhatextent.Experts’opinionsvaryastomedicaltreatmentbut,ingeneral,thetreatmentwindowvariesbetweenonedaytotwoweeks.Thecurrentlaboratorymethodscanreturnresultswithin3–21days,assumingamethodevenexists.Inanefforttoimprovestatepublichealthlaboratorycapacity,CDChasproposedaddingaradiologicalcomponenttotheLaboratoryResponseNetwork(LRN-R.)Inthisnetwork,fivestatepublichealthlaboratorieswouldprovidesurgecapacitytoCDCtoanalyzesamplesforpriorityradionuclidesusingtheURS.Havingthiscapabilitywilldrasticallyreduceresponsetimeforprovidinglocal,stateandfederaldecisionmakerswithhigh-quality,interpretableanalyticalresultsintheimmediateresponsephaseofaradiologicornuclearattack.Thisessentialnationalradioanalyticallaboratorycapacityshouldmarkedlyreducemorbidityandmortalityresulting

fromaradiologicalornuclearevent.Tohelpaddressgapsinthenation’sability

torespondtoradiologicterrorism,APHLisrequesting:• $6.3 millionfordevelopingandexpanding

CDC’sURStomeasure22high-priorityradionuclides.Thisextensiveresearcheffortincludes:• Researchonthebestmeasurement

approachesforapproximately11ofthe22targetedradionuclidesinhumanurine.

• SupportingessentialextramuralresearchwithDepartmentofEnergynationallaboratories.

• Purchasingspecializedequipmentandsupplies,includinginstrumentscapableofmeasuringalpha,betaandgammaradiation,inadditiontotwohigh-resolutionmassspectrometers.

• Developingradiologicreferencematerialsformethodvalidationandproficiencytesting.

• Developingandmaintainingbothaclinicalradiologicalproficiencytestingprogramandatrainingandtechnology-transferprogram.

• $4 millionforestablishingandmaintainingfiveLRNlaboratoriestocreateandmaintainregionalradiologicalLRNcapability.Fundingwouldbeusedto:• Purchasespecializedinstruments,including

thosethatcanmeasurealpha,betaandgammaradiation,andhigh-resolutionmassspectrometers.

• Hireradiologiclaboratorystaffinstates.• Supporttrainingfortheradiologiclabstaff.• SupportparticipationinCDC’sproficiency

testingprogram.

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