BiomoniToring - APHL · 2016-05-16 · and asbestos with cancer, many other chemical...
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The Association of Public Health Laboratories BIOMONITORING ANALYSIS OF HUMAN EXPOSURE TO CHEMICALS UNMET NEEDS • Provide $25 million in FY 2010 to fund CDC’s National Biomonitoring Program > $15M to fund states to build laboratory capacity and capability to monitor chemicals in people. > $10M to fund CDC to support state programs, develop methods, conduct studies and issue reports on monitoring disease and chemical exposures in people. BACKGROUND Every day we come in contact with thousands of chemicals. Though you would not knowingly breathe in air polluted with sulfur dioxide or drink water containing arsenic, chemicals in the environment often go unnoticed. While poor air quality has been linked with asthma, and asbestos with cancer, many other chemical exposure-health relationships are not known. Approximately 100,000 chemicals are currently registered for use in the US, yet we know very little about their effects on human health. As part of its National Biomonitoring Program, CDC’s Environmental Health Laboratory has measured levels of chemicals in people for the last 30 years. The data are used to assess exposure to environmental chemicals in the US population and provide valuable information when analyzed in conjunction with health outcome data. CDC currently has biomonitoring data available for hundreds of chemicals including perchlorate, bisphenol A (BPA) cotinine (a measure of secondhand tobacco smoke), flame retardants, certain pesticides and other complex chemicals. Biomonitoring data are critical in assessing people’s exposure to chemicals following both unintentional and intentional chemical events by identifying the chemical agent and determining which people were and were not exposed. Additionally, information from CDC about background levels of exposure can be used as a reference to determine when people have elevated levels of chemicals in their bodies. Ongoing monitoring of exposed populations by CDC ensures people receive proper care and treatment and helps decision makers determine which chemicals need regulation. PROGRAM APHL supports funding for the National Biomonitoring Program at CDC. Currently, the National Center for Environmental Health at CDC uses biomonitoring to measure specimens from participants in the National Health and Nutrition 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 20 09
Transcript of BiomoniToring - APHL · 2016-05-16 · and asbestos with cancer, many other chemical...
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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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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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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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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