SENTINELLABORATORYGUIDELINESFOR

SUSPECTEDAGENTSOFBIOTERRORISMAND

EMERGINGINFECTIOUSDISEASES

PackingandShippingInfectiousSubstances

REVISEDJANUARY1,2008

AmericanSocietyforMicrobiology

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SubjectMatterExperts,ASM

LarryD.Gray,Ph.D.TriHealthLaboratories,UniversityofCincinnatiCollegeofMedicine,andClinicalMicrobiologyLaboratoryConsultants,LLCCincinnati,OH

JamesW.Snyder,Ph.D.DepartmentofPathologyandLaboratoryMedicineUniversityofLouisvilleLouisville,KY

ASMLaboratoryGuidelineWorkingGroup

VickieBaselski,Ph.D.UniversityofTennesseeatMemphisMemphis,TN

RobertaB.Carey,Ph.D.

PeterGilligan,Ph.D.UniversityofNorthCarolinaHospitals/ClinicalMicrobiologyandImmunologyLabsChapelHill,NC

KarenKrisher,Ph.D.ClinicalMicrobiologyInstituteWilsonville,OR

JudithLovchik,Ph.D.IndianaStateDepartmentofHealthIndianapolis,IN

RosemaryHumes,M.S.,M.T.(ASCP)S.M.AssociationofPublicHealthLaboratoriesSilverSpring,MD

ChrisMangal,M.P.H.AssociationofPublicHealthLaboratoriesSilverSpring,MD

DanielShapiro,M.D.LaheyClinicBurlington,MA

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SusanSharp,Ph.D.KaiserPermanentePortland,OR

AliceWeisfeld,Ph.D.MicrobiologySpecialists,Inc.Houston,TX

DavidWelch,Ph.D.MedicalMicrobiologyConsultingDallas,TX

MaryK.York,Ph.D.MKYMicrobiologyConsultantsWalnutCreek,CA

CoordinatingEditor:

JamesW.Snyder,Ph.D.UniversityofLouisvilleLouisville,KY

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TableofContents

I. GoverningAuthoritiesandRegulationsA. OriginofRegulationsB. ImportanceofRegulationsC. EffectivenessofRegulationsD. ExceptionsE. SpecificRegulationsF. UnitedStatesPostalService

II. ClassificationofSubstancesA. ClassificationB. StepsinClassificationC. CategoryAInfectiousSubstancesD. CategoryBInfectiousSubstancesE. ExemptHuman orAnimalSpecimensF. ExemptSubstancesG. PatientSpecimensH. GeneticallyModifiedOrganismsI. BiologicalProductsJ. MedicalWasteK. InfectedAnimals

III. NamingCategoryAandCategoryBSubstances

IV. PackingInstructionsandPackingSubstancesA. PackingInstructionsB. ComparisonofPackingInstructionsandDirectionsC. PackingDirectionsforExemptHumanorAnimalSpecimens

V. MarkingandLabelingPackagesOuterPackagesA. SpecificMarkingsandLabelsB. ExamplesofMarkedandLabeledOuterPackages

VI. DocumentationA. ImportanceofShippersDeclarationB. EmergencyResponseTelephoneNumber

VII. Refrigerants

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VIII. TrainingandCertificationA. ApplicabilityB. EssentialComponentsC. TrainingMaterialsD. DocumentationofTrainingE. EnforcementofCompliance

IX. References

X. AppendixA: Recent SignificantChangesinIATARequirementsandDOTRegulations

XI. AppendixB:DefinitionsofTermsRelatedtoPackingandShipping

XII. AppendixC:SelectAgents

XIII. Tables

XIV. Figures

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PackingandShippingInfectiousSubstances

REVISEDJANUARY1,2008

Theinformationpresentedinthisprocedureisessentiallythesameinformationpresentedin theASMpublication ClinicalMicrobiologyProceduresHandbook(2007Update,ASMPress,Washington,DC) andisusedwithpermissionfrom theASM.

Theinformationinthisprocedureisnotandisnotintendedtobeanallinclusiveguidetopackingandshippingregulations.Theinformationisasummaryoftheauthorsinterpretationsofthecurrentrequirementsandregulations(asofJanuary1,2008)issuedbythefollowing: InternationalCivilAviationOrganization(ICAOaspecializedUnitedNationsagencywhich

promotestheinternationalstandardizationofessentiallyalltechnicalaspectsofaviation,includingthetransportofdangerousgoods)

InternationalAirTransportAssociation(IATAacommercialairlinetradeassociation)and UnitedStatesDepartmentofTransportation(DOTanagencyofthefederalgovernment).

Therequirementsandregulationsgoverningthetransportofinfectioussubstanceschangefrequently.Shippersareresponsibleforbeingawareofthesechanges,adheringtocurrentregulations,andinterpretingapplicableregulationsforthemselvesandtheirfacilities.

Alistof recentsignificantchangesinIATArequirementsandDOTregulationscanbefoundinAppendixA(6,7,11).

SeeAppendixBfordefinitionsofIATAandDOTtermsusedinthisprocedure.

I.GOVERNINGAUTHORITIESANDREGULATIONSA.OriginofRegulations

Shippingrequirementsandregulationsaredevelopedandpublishedbymanyauthorities,themostnotableofwhichareshowninTable1.Mostregulationsfortheairtransportofdangerousgoodsthroughouttheworldoriginateasdecisions(calledModelRegulations)madebytheUnitedNationsCommitteeofExperts(15).ICAOusestheseregulationstodevelopformalandstandardizedTechnicalInstructionsfortheSafeTransportationofDangerousGoodsbyAirforuseininternationalaviation(8,15).TheseTechnicalInstructionsarethestandardsfortheinternationalshipmentofdangerousgoodsbyair.IATAusestheseIACOTechnicalInstructionstodevelopDangerousGoodRegulationswhich areusedbyessentiallyallcommercialairlinesinvolvedinthetransportofdangerousgoods(7).IATArequirementshavebecomethemostwidelyrecognized,copied,andusedpackingandshippingguidelinesintheworld.Mostnationalandinternationalregulationsarebasedonorareatleastinsubstantialagreement(harmonization)withIATArequirements(13).

IntheUnitedStates,theDOTregulatesthecommercialtransportationofdangerousgoodsbybothairandgroundcarriers.JustasIATAderivesitsrequirementsfromICAO,theDOTalsoderivesitsregulationsfromICAO(6,11).OnJune2,2006,theDOTreviseditsregulationsforthetransportationofinfectioussubstancestobein substantial

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agreement(harmonization)withICAOrequirements(11).Forpracticalpurposes,shippersofinfectioussubstancescanconsidercompliancewithIATArequirementstobecompliancewithDOTregulations(6,11).

B.ImportanceofRegulationsLaboratoryworkerswhoshiportransportdangerousgoods,ingeneral,andinfectioussubstances,inparticular,byacommerciallandoraircarrierarerequiredtofollowacomplexandoftenconfusingsetofnationalandinternationalrequirementsandregulations.Thepurposeoftheserequirementsandregulationsistoprotectthepublic,emergencyresponders,laboratoryworkers,andpersonnelinthetransportationindustryfromaccidentalexposuretothecontentsofthepackages(6,8).Animportantnonsafetyrelatedbenefitofadherencetotheseregulationsandrequirementsistominimizethepotentialfordamagetothecontentsofthepackageduringtransportandtoreducetheexposureoftheshippertotherisksofcriminalandcivilliabilityassociatedwiththeimpropershipmentofdangerousgoods(6,8).

C.EffectivenessofRegulationsStatisticaldatashowthattheseregulationsareextremelyeffectiveinprotectingboththecontentsofpackagesandthepersonswhohandlethepackages.Todate,therearenoreportedcasesofillnessduetothereleaseofaninfectioussubstanceduringtransport.Only106(0.002%)ofthe4,920,000primarycontainersshippedin2003toworldwidelaboratoriesandotherdestinationswerereportedbrokenduringtransit. Ineachofthe106reportedbreakages,absorbentinappropriatelypreparedpackagescontainedtheleakingmaterial,andnoneofthesecondaryoroutercontainerswerereporteddamaged(15).

D.ExceptionsThetransportationofsmallquantitiesofnonCategoryAsubstances(usuallyspecimensbeingtransportedforclinical,diagnostic,orotherpatientcarepurposes)isexemptfrommostDOTregulationsifthespecimensaretransportedbyprivateorcontractcarrierinamotorvehicleusedexclusivelytotransportsuchsubstances(6,11).DOTconsiderssmallquantitiesofsuchsubstancestobematerialsoftrade. SuchsubstancesmustbepackedandsecuredinsidethevehicleaccordingtoDOTregulationshowever,theseregulationsarerelativelylenientandstatethatthesubstancesneedonlybeinleakproofcontainers,sealedsecurely,andsecuredwithinthevehicleduringtransport.ReadersshouldbeawarethattheusualstrictOSHAregulationsstillapplyduringthistypeoftransportationofinfectioussubstances.

E.SpecificRegulationsIATArequirementsandDOTregulationsmandatetheminimumstandardsforpackinginfectioussubstancesthatcanposeathreattohumans,animals,ortheenvironment.Thesafeandlegaltransportofthesesubstancesisbasedonthefollowingmandatedactivities: trainingofindividualsontherequirementsforappropriatepackagingandshippingof

infectioussubstances,documentationofthetraining,andsubsequentcertification(bytheemployer)ofthetrainee

classificationandnamingofthematerialtobeshipped

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selectionofpackagingthatwillcontainthecontentsifthepackageisdamaged,and,thus,willprotectcarrierpersonnelifthepackageisdamaged

packingtheshipmentcorrectly placingappropriateinformation(markingsandlabels)ontotheouterpackagetoalert

carrierpersonneltothehazardouscontentsofthepackageandtoidentifycontactsifanaccidentoccursand

documentingrelevantaspectsofeachpackageanditscontents.Eachoftheaforementionedactivitiesispresentedindetailinthefollowingsectionsofthisprocedure.

F.UnitedStatesPostalServiceTheUnitedStatesPostalServicepublishesitsownregulationsintheUSPSDomesticMailManual(14).TheUSPSregulationsformailinghazardousmaterialsgenerallyadheretoDOTregulations.

II.CLASSIFICATIONOFSUBSTANCESA.Classification

Shippingofalldangerousgoodsbeginswithclassificationofthesubstances.Classificationisamandatorythreestepprocesstodefinedangerousgoodsthatareshippedbycommercialcarriers(4,6,7,9,11).Classificationservestwopurposes:(a)itallowstheshippertoselecttheproperIATApackinginstructions(PI)anddirectionstouse,and(b)ifthesubstanceisaCategoryAinfectioussubstance,itprovidesimportantinformationnecessarytocompletedocumentation(aShippersDeclaration)whichmustaccompanyshipmentsofCategoryAsubstances.

B.StepsofClassification1. FirstStep

ThematerialmustbeclassifiedintooneofthenineIATAspecifiedclasses(Class1throughClass9)ofdangerousgoods(Table2).InfectiousandtoxicsubstancesareClass6dangerousgoodsdryiceisaClass9dangerousgood.Class6andClass9substancesusuallyaretheonlydangerousgoodsshippedbyclinicalmicrobiologists.

2. SecondStepClass6substancesmustbedividedintoeitherDivision6.1(toxicsubstances)orDivision6.2(infectioussubstances).

3. ThirdStepDivision6.2infectioussubstancesmustbeclassifiedintooneofnineIATAspecifiedtypesofinfectioussubstances(Table3): CategoryAinfectioussubstances CategoryBinfectioussubstances PatientSpecimens ExemptHumanorAnimalSpecimens GeneticallyModifiedOrganisms ExemptSubstances BiologicalProducts InfectedAnimals

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MedicalWaste

IfthesubstanceisdeterminedtobeapatientspecimenorageneticallymodifiedmicroorganismandisnotobviouslyaCategoryAorCategoryBsubstancebutitmeetsthecriteriaoforhascharacteristicsofaCategoryAorCategoryBsubstance,theshippermustclassifyitasaCategoryAorCategoryBsubstance.Otherwise,thesubstancemustbeclassifiedasanexempthumanoranimalspecimenorageneticallymodifiedorganism,respectively (Table3)(6,7,11).Fortunately,mostclinicalmicrobiologistswillfindessentiallyalloftheirsubstancesareeitherCategoryA,CategoryB,orexempthumanoranimalsubstances.

Decisionsmadeinthethirdstepcanbesubjectiveandcanbedifficulthowever,thesedecisionswill determineexactlyhowasubstancemustbepackedandshipped.ShippersmustnotarbitrarilyclassifyallsubstancesasBiologicalSubstance,CategoryB,ExemptHumanorAnimalSpecimen,orevenExemptSubstancestoavoidhavingtomakeimportantdiscriminatoryshippingdecisionsortomakepackingeasierorlessexpensive.Suchcavalierclassificationisillegalandcanbeoverlyexpensive.

C.CategoryAInfectiousSubstancesACategoryAsubstance(pathogenoragent)isaninfectioussubstancewhichistransported inaform that,whenexposuretoitoccurs,iscapableofcausingpermanentdisability,orlifethreateningorfataldiseasetootherwisehealthyhumansoranimals(7).

1. ListofCategoryASubstancesDecidingifaninfectioussubstanceisaCategoryAsubstanceisrelativelyeasybecauseCategoryAsubstancesarespecificallydesignatedandlistedbyIATAandDOT(Table4).ThelistofCategoryAsubstancesisnotallinclusive,andathoroughriskassessmentmustbeperformedbeforeassigningasubstancetoCategoryA.CategoryApathogensareessentiallythesameasthosepreviouslyclassifiedasforbiddensubstancesandRiskGroup4substances.

2. DecisionstoClassifyaSubstancesasCategoryAIATArequirementsallowshipperstousetheirdiscretionandprofessionaljudgementwhendecidingifasubstancemeetsCategoryAcriteria.IATA DangerousGoodsRegulationsstatethefollowing: regardingjudgement: AssignmenttoUN2814orUN2900[i.e.,CategoryA]

mustbebasedontheknownmedicalhistoryandsymptomsofthesourcehumanoranimal,endemiclocalconditions,orprofessionaljudgementconcerningindividualcircumstancesofthesourcehumanoranimal.

regardingassigninginfectiousagentswhich,intheshippersopinion,meetCategoryAcriteria,butwhicharenotspecificallylistedasaCategoryAagent:...infectioussubstances...whichdonotappearinthetablebutwhichmeetthesamecriteriamustbeassignedtoCategoryA.

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regardinguncertaintyofCategoryAcriteria: ...ifthereisdoubtastowhetherornotasubstancemeetsthecriteria[ofCategoryA]itmustbeincludedinCategoryA.(7).

3. UNNumbersofCategoryAPathogensCategoryApathogensandsubstanceslikelytocontainCategoryApathogensmustbeassignedtheUNnumberUN2814(propershippingname:InfectiousSubstance,AffectingHumans)orUN2900(propershippingname:InfectiousSubstance,AffectingAnimals)(Fig1)(7).

4. AgentsofBioterrorismSomeCategoryApathogenshavebeendesignatedasagentsofbioterrorismandareknownasselectagents(AppendixC).UnitedStatesfederalregulationsrequireshipperstohavespecialpermitstopossess,use,transfer,andreceivetheseagents(1,2,3,5).

D.CategoryBInfectiousSubstancesACategoryBsubstanceisdefinedbyIATAasaninfectioussubstancewhichdoesnotmeetthecriteriaforinclusioninCategoryA(Fig.1)(Table3)(7).CategoryBsubstancesarenotinaformgenerallycapableofcausingdisability,lifethreateningillness,orfataldisease.Intheauthorsopinion,examplesof possibleCategoryBsubstancesarethefollowing: typicalclinical,diagnostic,orpatientspecimens,e.g.,blood,biopsies,swab

specimens,excreta,secreta,bodyfluids,tissues,etc.,(a)beingshippedforroutineculturingorothertestingfornonCategoryAinfectiousmicroorganism(s)or(b)suspectedofcontaininganonCategoryAmicroorganism(s),and

typicalclinicallaboratorycultures(usuallyonsolidorinliquidmedia)ofroutinelyencounterednonCategoryAmicroorganismsgrownandusedinclinicalmicrobiologylaboratories.CategoryBsubstancesmustbeassignedUNnumberUN3373(BiologicalSubstance,CategoryB)(7,11).

E.ExemptHuman(orAnimal)SpecimensExemptHumanorAnimalSpecimensarethoseforwhichthereisminimallikelihoodtherearepathogenspresent(Fig.1)(Table3)(7).Examplesofsuchspecimensincludeurineorserumtobetestedforglucose,cholesterol,hormonelevels,prostatespecificantigen,andanalytesusedtoevaluateheartandkidneyfunction.Professionaljudgementandknowledgeofpatientmedicalhistorymayusedtodetermineifthespecimenisaninfectiousriskorcontainspathogens.Historically,suchspecimenswerepackedandshippedasClinicalSpecimensorDiagnosticSpecimens.ExemptHumanorAnimalSpecimenshavelessstringentpackagingrequirementsthandoCategoryAandCategoryBsubstances.IATArequiresouterpackageswhichcontainExemptHumanorAnimalSpecimenstobeclearlylabeledasExemptHumanSpecimenorExemptAnimalSpecimen(7).DOTdoesnotrequirethislabelonouterpackages(11).

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F.ExemptSubstancesManysubstancescommonlyencounteredinclinicallaboratoriesareexemptfromthestrictdangerousgoodsshippingrequirementsandregulationswhichapplytoCategoryAandCategoryBsubstancesandtoExemptHumanorAnimalSpecimens(Fig.1)(Table3)(7,10).Thefollowingareexamplesofsuchexemptsubstances: substanceswhichdonotcontaininfectioussubstancesorareunlikelytocausedisease

inhumansandanimals substanceswhichcontainnonpathogenicmicroorganisms mostenvironmentalsamples(food,soil,etc.)whichdonotposeahealthriskto

humansoranimals substanceswhichcontainneutralizedorinactivatedmicroorganismsthatdonotpose

ahealthrisktohumansoranimals substancestobetestedfortherapeuticdrugmonitoring,insurancepurposes,alcohol

ordrugs,pregnancyindicators,cancer,andantibodies driedbloodspotsandfecaloccultbloodscreenspecimens bloodandbloodcomponentscollectedforthepurposeoftransfusionorforthe

preparationofbloodproductstobeusedfortransfusionortransplantationandanytissueororgansintendedforuseintransplantation

FDAapprovedandFDAlicensedbiologicalproductsand

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J.MedicalWasteMedicalwastewhichcontainsCategoryAorCategoryBinfectioussubstancesmustbepackedandshippedassuchandassignedUN2814,UN2900,orUN3373(Table3)(7).MedicalwastewhichisreasonablybelievedtohavealowprobabilityofcontaininginfectioussubstancesmustbepackedandshippedasMedicalWaste,n.o.s.(UN3291)(7).

K.InfectedAnimalsAliveintentionallyinfectedanimalthatisknowntocontainorreasonablyexpectedtocontainaninfectioussubstancecannotbetransportedbyairunlessthesubstancecannotbetransportedbyanyothermeans(7).Consultationwithindividualcommercialcarriersisadvisedifeitherliveordeadinfectedanimalsneedtobeshipped.

III.NAMINGCATEGORYAANDCATEGORYBSUBSTANCESAfterclassifyingthesubstance,theshippermustidentify(officiallyname)aCategoryAandCategoryBsubstancebyassigningthesubstanceoneoftheover3,000IATAspecifiedandinternationallyrecognizedUNnumbersandpropershippingnameslistedintheIATArequirements(7).PropershippingnamesandtheirassociatedUNnumbersarespecificallylistedandpublishedinternationallybyIATAsothatmostcarriersaroundtheworldwillrecognizethegeneralgrouporkindofinfectiousagentordangerousgoodtheyarehandling.Thislistprovides14informationalitems(AthroughN)foreachofthepropershippingnamesandUNnumbers(Table5).The14itemscorrespondconvenientlytotheinformationneededtocompletetheShippersDeclaration.Fortunately,onlysevenofthe3,000propershippingnamesareusedbymostclinicalmicrobiologylaboratories:twonamesforCategoryAinfectioussubstanceswhichaffecthumans(oneforliquidsandoneforsolids),twonamesforCategoryAinfectioussubstanceswhichaffectanimals(oneforliquidsandoneforsolids),onenameforCategoryBsubstances,onenameforgeneticallymodifiedorganisms,andonenamefordryice(Table6). Table6showsthesevenIATAandDOTdesignatedinfectioussubstancescommonlyshippedbyclinicalmicrobiologists.Thetableprovidespropershippingnames,UNnumbers,packinginstructions,quantitylimits,andotherinformationrelatedtopackingandshippingthesesubstances.Informationinthistablewastakendirectlyfrom2006IATA DangerousGoodsRegulations(7).

IV.PACKINGINSTRUCTIONSANDPACKINGSUBSTANCESA.PackingInstructions

DOTregulations,IATArequirements,andIATAPackingInstructions(PI)describetheminimumstandardsforthesafetransportofvariousbiologicalmaterials.Shippersarelegallyresponsibleforcomplyingwiththeseregulations,forfollowingprescribedPI,andforpackingsubstancescorrectlytoensurethesafetyofallpersonnelwhohandlethepackagebefore,during,andevenaftershipmenttothepointofacceptanceofthepackagebytheconsignee.Afterdeterminingtheexactnatureandcategoryofthesubstancetobeshipped,theshippermustselectthemostappropriatePIandpackingdirectionstouse(Fig.1)(Table6).Generally,thePIusedbyclinicallaboratoriesarethosethatrelatetoshippingCategoryAinfectioussubstances(PI602)CategoryBinfectioussubstances(PI650)anddryice(PI904).TherearenospecificallynumberedPIforspecimensclassifiedasExemptHumanorAnimalSpecimenshowever,IATAprovidesdirections

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whichmustbefollowed(7).SeeTable7foracomparisonofthedetailsofpackinginstructionsanddirections.

B.ComparisonofPackingInstructionsandDirectionsDetailsofthesimilaritiesofanddifferencesbetweenPI602,PI650,andthedirectionsforpackingExemptHumanorAnimalSubstancesareshowninTable7.Themajorsimilaritythesethreeinstructionshaveincommoniscommonlyknownastriplepackaging.Initssimplestform,triplepackagingconsistsofaprimarycontainer,asecondarycontainer,absorbentbetweenthecontainers,andanoutershippingcontainer.Themajordifferencesbetweentheseinstructionsarethoseassociatedwithdocumentationandwithmarkingandlabelingoutercontainers.ThefollowingarethemaincomponentsofPI602andPI650 aleakproofprimarycontainermadeofglass,metal,orplasticand,ifitcontainsa

CategoryAinfectioussubstance,sealedbyapositivemethod(e.g.,heatseal,metalcrimp,ortapedscrewcaplid).ForCategoryAandCategoryBsubstancestobeshippedineitherpassengerorcargoaircraft,themaximumallowablevolumeperprimarycontaineris50mL(50g)and1L(4kg)forCategoryAandCategoryBsubstances,respectively.

absorbentmaterialsufficienttoabsorballliquidcontainedwithintheprimarycontainer(s)incaseofbreakageplacedbetweentheprimaryandsecondarycontainers.Absorbentmaterialisnotrequiredifthematerialbeingshippedisasolid.Absorbentmaterialshouldbeusedwithliquidsshippedinafrozenstate.

aleakproofsecondarycontainerwhichcontainstheprimarycontainer(s). rithertheprimaryorsecondarycontainermustbeabletowithstandaninternal

pressureofatleast95pKa(13.8lbs/in2)becauseshipmentsarelikelytobeplacedintounpressurizedcargosectionsofaircraftwhichflyathighaltitudes.

alistofthecontentsandquantitiesoftheprimarycontainer(s)mustbeattachedtotheoutsideofthesecondarycontainer.

arigidanddurableouterpackageofadequatestrengthforitsintendeduseandconstructedofcardboard,wood,ormaterialofequivalentstrengthandwhichmeasuresatleast4x4onatleastonesurface.ForshippingCategoryAinfectioussubstances,theseoutercontainersmustmeetstrictUnitedNationsmanufacturingandtestingspecifications.

C.PackingDirectionsforExemptHumanorAnimalSpecimensPackagingusedwithExemptHumanorAnimalSpecimensislessstrictthantheaforementionedrequirementsinpackinginstructions650and602.However,suchpackagingmustbecomposedoffourimportantelements:(a)aleakproofprimarycontainer,(b)aleakproofsecondarycontainer,(c)forliquidsubstances,absorbentmaterialofsufficientquantitytoabsorbtheentireliquidmustbeplacedbetweentheprimaryandsecondarycontainers,and(d)outerpackagingofadequatestrengthforitsintendedcapacity,mass,andintendeduse(Table7)(7).

V.MARKINGANDLABELINGOUTERPACKAGESMarkingistheactofwritingortypinginformationontotheoutersurfaceofanouterpackage,andlabelingistheactofplacinginformationallabelsorstickersontothesurfaceof

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anouterpackage.Thetwotermsfrequentlyareusedinterchangeably.Theshipperisresponsibleforthepropermarkingandlabelingoftheoutershippingcontainer.Themarkingsandlabelsontheoutercontainercommunicateessentialinformationregardingtheshipperandconsigneeofthepackage,natureandweightofthecontentsofthepackage,thepotentialhazardofthesubstance,howthesubstanceispacked,andinformationtobeusedincaseofanemergency.SomeofthesemarkingsandlabelscanbeseenintheIATADangerousGoodsRegulationsandotherpublications(6,7,11).A.SpecificMarkingsandLabels

1. ShipperandConsignee theshippersandconsigneesnameandaddress2. ResponsiblePersonThenameandtelephonenumberofapersonresponsible

(IATA quote)forthecontentsoftheshipment(7).Theauthorsinterpretationofresponsiblepersonissomeonewhoisfamiliarwiththeshipmentandcananswergeneralquestionsabouttheshipment(notnecessarilyquestionsregardingemergencyoraccidentmitigationresponseinformation). IfthesubstancebeingshippedisaCategoryBsubstance,thisinformationmaybeprovidedeitherontheouterpackageorontheairwaybill(7).

3. CategoryASubstances (a)theClass6diamondshapedlabelInfectiousSubstance.InCaseofLeakage...label,and(b)alabelwhichshowsthepropershippingname,UNnumber,andquantityofthesubstance(Fig2).TheClass6infectioussubstancelabelisidenticalforallregulatingagenciesexcepttheDOTversionspecifiesnotificationoftheCDCbyuseofan800number.

4. CategoryBSubstances(a)thelabelBiologicalSubstance,CategoryBand(b)themarkingorlabelUN3373(Fig.3)

5. DryIceClass9MiscellaneousDangerousGoodslabelandtheweightofdryice(Fig.4)

6. PackageOrientation packageorientationlabel(Fig.5).Orientationlabels(arrows)mustbeplacedonoppositesidesofallpackageswhichcontain>50mLofaliquidorfrozenliquidinfectioussubstancetoindicatethecorrectorientationof thepackage.

7. CargoOnlyCargoAircraftOnlylabelifthesubstance(becauseofitsquantity)mustbetransportedonlybycargoaircraft(Fig.6).Thislabelisusedifinfectioussubstanceamountsover50mL(5g)butlessthan4L(4kg)perouterpackageareshipped.

8. Overpack Overpackmarkingsifoverpacksareused(Fig.7)9. ExemptPatientSpecimens PatientspecimensnotclassifiedasCategoryAor

CategoryBmustbelabeledclearlyasExemptHumanSpecimenorExemptAnimalSpecimen(Fig.8).ThisrequirementisspecifiedonlybyIATA,notbyDOT(7,11).

10. OuterPackageAllouterpackagingusedtoshipCategoryAinfectioussubstancesandsubstancesconsideredbytheshippertobeaninfectiousrisktothehealthofcarrierpersonnelmustmeetmanufacturingandperformancespecificationsestablishedbytheUnitedNationsandmustbemarkedassuchbythemanufacturer.PackagingthatmeetstheUNspecificationsaremarkedbyaUNinsideofacircle,andaseriesoflettersandnumberswhichindicatethetypeofpackage,classofgoodsthepackageisdesignedtocarry,manufacturingdate,authorizingagency,andthemanufacturer(Fig.9).ThedesignationClass6.2inthemarkedcodeindicatesthat

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thecontainerisapprovedforshippinginfectioussubstances.ThesecontainersarecommerciallyavailableandarepreprintedwiththeappropriateUNmarking.ThestrictUNspecificationsforouterpackagingdonotapplywhenshippingCategoryBsubstances.OuterboxesusedtoshipCategoryBsubstancesneedonlytoberigidandstrongenoughfortheirintendedpurposeandbeabletopassa3.9footdroptest(7).

B.ExamplesofLabeledandMarkedOuterPackagesFigures10,11,and12showsimplifedexamplesofcompletelylabeledandmarkedoutershippingcontainerswhichcontainanExemptHumanSpecimen,aCategoryBinfectioussubstance,andaCategoryAinfectioussubstance,respectively.PackagesinFigures11and12alsocontaindryice.Forconvenienceandlowercosts,oneormore triplepackagespackedinfullcompliancewithIATAregulationsmaybeshippedwithinasingleoverpackwhichdoesnothavetomeetUNspecifications.However,theoverpackmustbelabeledOverpack,andallinnerpackagesmustbecompletelylabeledaccordingtoapplicableIATAregulations(Fig.7).

VI.DOCUMENTATIONA.ImportanceofShippersDeclarations

AShippersDeclarationisalegalcontractbetweentheshipperandcarrier,isrequiredtodocumenttheshipmentofCategoryAinfectioussubstances,mustbeaccurate,andmustbelegibleorthecarriermayrejectthepackagefortransport.AShippersDeclarationisrequiredfordryice(adangerousgood)ifdryiceisusedasarefrigerantforaCategoryAsubstance,butnotforaCategoryBsubstance.SomecarriersrequiretheShippersDeclarationtobetypedsomerequiremultiplecopies.TheoriginalShippersDeclarationgiventothecarriermusthaveverticalredcandystripesalongtheleftandrightedgesofthedocument.ShippersmustretaincopiesofShippersDeclarationsfortwoyears(10).Allcorrectionsmustbeneatlylinedout andallchangemustbesigned(notinitialed)bythesamepersonwhosignedthedocument.AcarriermayrejectashipmentifeachfieldontheShippersDeclarationisnotcompletedexactlytothecarrierssatisfaction,andiftheinformationandphrasingontheShippersDecalarationdonotmatchexactlythecorrespondinginformationontheouterpackage.CommercialcarriersandtheFederalAviationAdministrationoftenexercisetheirauthorityatairportstoexamineShippersDeclarationsforcompliancewithapplicableregulationsandtoopenandinspectanypackage(whetherornotthepackageisleaking)whichcontainsorissuspectedofcontaininganinfectioussubstance.Inaddition,theseagenciescananddoexaminedocumentationofperfectlypackagedshipments,gotothefacilitiesfromwhichthepackagesoriginated,andrequestdocumentationofadequatetrainingofemployees.Figure13showsablankShippersDeclarationandthe13sectionswhichshippersmustcomplete.EssentiallyalloftheIATAspecifiedtechnicalinformationrequiredtocompletethesevensubsectionsofsectionnine(NatureandQuantityofDangerousGoods)ofthedocumentcanbefoundinTable6andreference7.Figure14showsacompletedandacceptableShippersDeclaration.

B.EmergencyResponseTelephoneNumberDOT,butnotIATA,regulationsstateanemergencyresponsetelephonenumbermustbeprovidedonShippersDeclarationswhichaccompanyshipmentsofCategoryA

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infectioussubstances(12).Thenumbermustbemonitoredatalltimesbyaperson(notanansweringmachine,messageservice,pager,etc.)whohasknowledgeofthefollowing:(a)thehazardsofthematerialbeingshippedand(b)emergencyresponseandaccidentmitigationinformationincaseahandlercontactsthereleasedcontentsofthepackage.Alternatively,thenumbercanbethatofapersonwhohasimmediateaccesstoapersonwhohassuchknowledgeandinformation.Thenumberofanagency,organization,orcommercialcompanymaybeusedinsteadoftheaforementionedpersonsiftheshippercanensuretheagency,organization,orcompanycansupplytherequiredaforementionedemergencyinformationinatimelymanner.

VII.REFRIGERANTSWetanddryicearetwocommonrefrigerantsusedtoshipdiagnosticspecimensandinfectioussubstances.Packagingmustbeleakproofwhenweticeisused.DryiceisaClass9dangerousgood,itmustbepackagedaccordingtoPI904,anditsuserequirescompletionofaShippersDeclarationifitisusedtoshipaCategoryAsubstance.Thesecondarycontainermustbesecuredsothatitdoesnotbecomelooseasthedryicesublimates.OuterpackagesmustbelabeledDryIce,andthenetweightofthedryicemustbeindicatedontheoutsideoftheouterpackageandberecordedontheShippersDeclaration(Figs.4,11,and12).Themaximumpermittednetweightofdryiceperouterpackageis200kg.NOTE: Dry iceisanexplosionhazardandmustneverbeplacedintoatightlysealedcontainer!Dryicemustbeplacedoutsidethesecondarycontainer,andtheouterpackagingmustpermitthereleaseofCO2!

VIII.TRAININGANDCERTIFICATIONDOTandIATAprovidesurprisinglittledirectionanddetailsfortrainingshippers.Neitherorganizationprovidesmuchhelpfulinformationregardingwhoshouldorcanbeatrainer,howtrainingshouldbeperformed,detailedcontentsoftraining,howtestingistobeperformed,thedefinitionofapassinggrade,andhowtodetermineifapersonisadequatelytrained.A.Applicability

Anyoneinvolvedintheshippingortransportationofdangerousgoods(includinginfectioussubstances)mustbetrainedandcertifiedintheshipmentofdangerousgoods(6,7,11).2005WHOguidelinesstatethatonlypersonswhopackandshipCategoryAinfectioussubstancesmustreceivetheaforementionedformaltrainingandcertification(15).PersonswhopackandshipCategoryBinfectioussubstancesandexempthumanandanimalspecimensneedtoreceiveonlygeneralandpracticaltrainingsuchasclearinstructionsontheuseofpackagingandtrainingandawarenessoftheimportanceofpackingsubstancesappropriatelycertification(15).Suchpersonsshouldandreceiveclearinstructions,guidance,andtrainingappropriateforpackingandshippingCategoryBinfectioussubstancesanddiagnosticspecimens,addressingspills,andprotectingthemselvescertification(15). NOTE: Asof October16,2007,IATAandDOThavenotadoptedtheserecentlyrelaxedandseparatetrainingrequirementsforshippersofCategoryBsubstances.UntilsuchrequirementsareadoptedbyDOT,shippersshouldbeformallytrainedandcertifiedasiftheywillpackandshipboth CategoryAandCategoryBsubstances.

17

B.EssentialComponentsTheessentialcomponentsofatrainingprogrammustincludethefollowing:1. generalawarenessandfamiliaritywiththemanyaspectsofshippingdangerousgoods2. importance,nature,andcontentsofIATAandDOTregulations3. functionspecifictraining(handsonand/ordemonstrationsofpackagingandpacking

techniques)4. markingandlabeling5. documentationofshipmentsofdangerousgoods6. safetytraining7. securitytraining(ifapplicabletoatraineesjobresponsibilities)8. testing9. issuanceofacertificateaftersuccessfulcompletionofthetraining(6,7).

C.TrainingMaterialsAcceptabletrainingmaterialsandmethodsincludemanuals,trainingcourses,andworkshops,allofwhicharecommerciallyavailablefromprofessionalorganizationsandcommercialsuppliersofpackagingmaterialsfordangerousgoods.Alternatively,atrainingprogramorworkshopwhichincludeshandsontraininganddemonstrationscanbedevelopedbyanyhospital,laboratory,school,institution,orotherfacilitythroughthedirectionofacertifiedtrainer.Alltrainingprogramsshouldbedesignedtoprovideinitialandregularfollowuptrainingtoeachemployeeresponsibleforshippingandpackinginfectioussubstances.Trainingandtrainingmaterialforthetransportationofdangerousgoodsandinfectioussubstancesisavailableatthefollowingsources:1. AmericanSocietyforMicrobiology(www.asm.org)2. InternationalAirTransportAssociation(trainingmanuals)(www.iata.com)3. regionalandnationalclinicalmicrobiologymeetings(workshopsandpresentations)4. manymajoruniversitiesandmedicalcenters5. manystatedepartmentsofhealthandpublichealth6. manyprofessionalscientificorganizations7. SafTPak(www.saftpak.com)8. CARGOpak(www.cargopak.com)9. DangerousGoodsInternational(www.dgitraining.com)10. ICCTheComplianceCenter(www.thecompliancecenter.com)11. WorldCourierTrainingCourse(www.worldcourier.com)12. CasingScientific(www.casingcorp.com)

D.DocumentationofTrainingIATAandDOTrequireall aspectsoftrainingtobedocumented.Themostimportantdocumentusedtoproveappropriateandtimelytrainingisacertificatewhichisissuedaftertrainingiscomplete.Employersshouldkeeparecordforeachemployeewhoistrained.Therecordshouldincludeemployeesname,locationanddateoftraining,nameofthetrainer,coursecontent,documentationoftesting,andacopyofthecertificateoftraining.IATAandDOTcertificationisvalidfor2and3years,respectively.

http://www.saftpak.com/http://www.cargopak.com/http://www.dgitraining.com/http://www.thecompliancecenter.com/http://www.worldcourier.com/

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E.Enforcementof ComplianceTheDOTandtheFederalAviationAdministrationhaveauthoritytoperformunannouncedinspectionsoffacilities(e.g.,clinicallaboratories)thatshipdangerousgoods,andtoinspectthethesefacilitiesforcompliancewiththetrainingregulationsandtoinspecttrainingrecordsatthesefacilities.Facilitieswhichdonotcomplywithprescribedregulationsaresubjecttosubstantialfines.

IX. REFERENCES1. AnimalandPlantInspectionService,UnitedStatesDepartmentofAgriculture.

2005.Agriculturalbioterrorismprotectionactof2002:Possession,use,andtransferofbiologicalagentsandtoxinsfinalrule(7CFRPart3319CFRPart121).Fed.Regist.70:1324213292.

2. CentersofDiseaseControlandPreventionandtheOfficeof theInspectorGeneral,UnitedStatesDepartmentofHealthandHumanServices.2005.Possession,use,andtransferofselectagentsandtoxinsfinalrule(42CFRParts72 etal.).Fed.Regist.70:1329413325.

3. CentersofDiseaseControlandPreventionandUnitedStatesDepartmentofHealthandHumanServices.2005.Possession,use,andtransferofselectagentsandtoxinsreconstructedreplicationcompetentformsofthe1918pandemicinfluenzaviruscontainingregionsofalleightgenesequencesinterimfinalrule(42CFRPart73). Fed.Regist.70:6104761049.

4. Denys,G.A.,L.D.Gray,andJ.W.Snyder.2004.Cumitech40,Packingandshippingdiagnosticspecimensandinfectioussubstances.Coordinatinged.,D.L.Sewell.AmericanSocietyforMicrobiology,Washington,DC.

5. Gilchrist,M.J.R.,W.P.McKinney,J.M.Miller,andA.S.Weissfeld.2000.Cumitech33,Laboratorysafety,management,anddiagnosisofbiologicalagentsassociatedwithbioterrorism.Coordinatinged.,J.W.Snyder.AmericanSocietyforMicrobiology,Washington,D.C.

6. Gray,L.D.andJ.W.Snyder. 2006.Chapter21.PackingandShippingBiologicalMaterials. InBiologicalSafety PrinciplesandPractices(4thedition).D.O.FlemingandD.L.Hunt,eds.ASMPress,Washington,DC.

7. InternationalAirTransportAssociation. 2008. DangerousGoodsRegulations, 49thedition.InternationalAirTransportAssociation,Montreal,Canada.

8. McKay,J.andD.O.Fleming. 2000. Chapter27. Packagingandshippingbiologicalmaterials,p.411 425. InBiologicalSafety PrinciplesandPractices(3rdedition).D.O.FlemingandD.L.Hunt,eds.ASMPress,Washington,DC.

9. Snyder,J.W. 2002.Packagingandshippingofinfectioussubstances. Clin.MicrobiolNewsletter.24:8993.

10.UnitedStatesDepartmentofTransportation,PipelineandHazardousMaterialsSafetyAdministration. 2005.Hazardousmaterials.Incorporationofstatutorymandatedrevisionstothehazardousmaterialsregulations(49CFRParts105etal.). Fed.Reg.70:7316473166.

11.UnitedStatesDepartmentofTransportation,PipelineandHazardousMaterialsSafetyAdministration.2006.Hazardousmaterials:infectioussubstancesharmonizationwiththeUnitedNationsrecommendationsfinalrule(49CFRParts171etal.). Fed.Regist.71:3224432263.

19

12. UnitedStatesDepartmentofTransportation,ResearchandSpecialProgramsAdministration. 2004.Hazardousmaterials.Miscellaneouschangestothehazardouscommunicationrequirementsfinalrule(49CFRParts171etal.). Fed.Reg.69:6446864473.

13. UnitedStatesDepartmentofTransportation,ResearchandSpecial ProgramsAdministration.2004.HarmonizationwiththeUnitedNationsRecommendations,InternatioanalMaritimeDangerousGoodsCode,andInternationalCivilAviationOrganizationsTechnicalInstructionsfinalrule(49CFRParts171etal.). Fed.Reg.69:7604476092.

14. UnitedStatesPostalService. 2006.Domesticmailmanual.(http://pe.usps.com/DMMdownload.asp).

15.WorldHealthOrganization. 2005.GuidanceonRegulationsfortheTransportofInfectiousSubstances.WorldHealthOrganization,Geneva(http://www.who.int/csr/resources/publications/biosafety/WHO_CDS_CSR_LYO_2005_22/en).

X.APPENDIXA RecentSignificantChangesinIATARequirementsandDOTRegulations1. Classificationofinfectioussubstancesaccordingtoriskgroupshasbeenreplacedby

classificationofsubstancesintoeitherCategoryAsubstance,CategoryBsubstance,ExemptHumanorAnimalSpecimen,ExemptSubstance,andPatientSpecimen.

2. Thetermscultureandpatientspecimenhavebeendefined,andthedefinitionsaremoreuserfriendly.Theterm laboratorycultureisnolongerused.

3. MinimalpackingdirectionsforExemptHumanorAnimalSpecimenhavebeenprovided.Therearenospecific,detailed,andnumberedpackinginstructionssuchasPI602andPI650.

4. ThetechnicalnameofaCategoryAsubstancepackedaccordingtoPI602isnolongerrequiredontheouterpackage.Forexample,apackageformerly labeledInfectiousSubstance,AffectingHumans(HepatitisCVirus)nowshouldbelabeledInfectiousSubstance,AffectingHumans.ThetechnicalnameisstillrequiredonShippersDeclarations.

5. PackingInstruction650 TheonlyacceptablepropershippingnameforaCategoryBsubstanceisBiological

Substance,CategoryB.ThetermsClinicalSpecimenandDiagnosticSpecimenarenolongerallowed.

Quantitylimitshavebeenrevisedtoallowupto1Lofliquid/primarycontainer. nowmandatesuseofrigidoutercontainers PackagesmustbemarkedwithadiamondsymbolwhichcontainsUN3373,anda

BiologicalSubstance,CategoryBmarkingadjacenttothediamond.6. Ifanairwaybillisused,theNatureandQuantityofGoodsbox(orequivalentarea on

theairwaybill)shouldindicatetheappropriatepropershippingname,e.g.,BiologicalSubstance,CategoryB(UN3373),CategoryASubstance(UN2814),andExemptHumanSpecimen.NOTE: AsofSeptember11,2007,IATAandDOTdonotrequiretheaforementionedinformationbeprovidedonanairwaybillhowever,sucharequirementisanticipatedinthenearfuture.

20

7. ThePriorarrangementsasrequiredstatementintheAdditionalHandlingInformationsectionoftheShippersDeclarationisnolongerrequired.

8. Therequirementforanaireligibilitylabelormarking(airplanesymbolinsideofacircle)hasbeenreplacedbythefollowingcertificationstatementontheShippersDeclaration:Ideclarethatalloftheapplicableairtransportrequirementshavebeenmet.

9. ThesequenceofinformationwithintheNatureandQuantityofDangerousGoodssectionoftheShippersDeclarationofDangerousGoods mustbeginwiththeUNnumberinthefirstcolumn.

10. OverpacksmustbelabeledOverpackinsteadof thepreviouslyrequiredInnerPackagesComply

11. Severalexemptionstoregulationshavebeendefined.12. Personswhopackandshipselectagentsandtoxins,andCategoryAagentsmustreceive

securitytrainingcommensuratewiththeirresponsibilities.13. Somehazardousmaterials,e.g.,10%formalin,usedasapreservativeareexemptfrom

requirementsandregulationsifthequantityis

21

CategoryBsubstance aninfectioussubstancewhichdoesnotmeetCategoryAcriteria.CategoryBsubstancesgenerallyareconsideredtobethefollowing:(a)patientorclinicalspecimensreasonablyexpectedtocontain,orbeingculturedorotherwisetestedforapathogen,and(b)microorganismsnotspecificallylistedinCategoryA. ThepropertermforaCategoryBsubstanceisBiologicalSubstance,CategoryB.

CodeofFederalRegulation(CFR) UnitedStateslawspublishedintheFederalRegisterandavailableonlineathttp://www.gpoaccess.gov/fr/index.html

consignee thereceiveroftheshipment(e.g.,areferencelaboratory).culture theresultofaprocessbywhichpathogensareintentionallypropagated.This

definitionreferstotypicalclinicallaboratorymicroorganismsgrowninbrothoronsolidmedia.TypicalclinicalculturesmaybeclassifiedaseitherCategoryAorCategoryB,dependingontheorganismconcernedandtheprofessionaljudgementoftheshipper.

dangerousgoodsmaterialwhich,whennotproperlyhandledandcontained,canposearisktothehealth,safety,property,orenvironmentandwhichandwhichareshownthelistofdangerousgoodsinIATA DangerousGoodsRegulations.

DangerousGoodsRegulations(DGR)acommerciallyavailablebookofIATArequirementspublishedbyIATAbasedonandincorporatesICAOregulationsprovidespackagingandshippingregulationsfordangerousgoodsgenerallyrecognizedandacceptedworldwide.

diagnostic(orclinical)specimen termnolongerusedorallowed replacedbyBiologicalSubstance,CategoryB.

geneticallymodifiedmicroorganism(GMO) microorganismsthathavehadtheirgeneticmaterialpurposelymodifiedoralteredthroughgeneticengineeringinamannerthatdoesnotoccurnaturallymustbeclassifiedinthesamemannerandtothesameextentasanyinfectioussubstance.

InternationalAirTransportAssociation(IATA)atradeorganizationofthecommercialairlineindustry governsinternationalaviationpublishesDangerousGoodsRegulationsforusebyanyonewhopacks,ships,transports,orhandlesdangerousgoods.

InternationalCivilAviationOrganization(ICAO)aspecializedagencyoftheUnitedNationsgovernsinternationalaviationregulatesthetransportationofdangerousgoodsforallinternationalcivilaircarriersthesourceofIATArequirementsandDOTregulations.

infectioussubstanceasubstancewhichisknowntocontainorreasonablyexpectedtocontainpathogens(microorganismswhichcancausediseaseinhumansandanimals)materialknowntocontainorreasonablysuspectedofcontainingaCategoryAorBpathogenorsubstancecanbeaclass(Class6),adivision(Division6.2),oracategory(CategoryAorB)ofdangerousgoodsasdefinedbyIATA.

overpack theoutmostpackagingusedtoenclosemorethanonecompletepackage,eachofwhichcontainsdangerousgoodsusuallyusedforconvenienceandtoreduceshippingcosts

packageendproductofthepackingprocess.packagingallofthenumerousmaterialsusedtocontainashippedsubstanceandto

preparethesubstanceforshippingthecontainer(receptacle)anditsassociatedcomponents(e.g.,tubes,containers,absorbentmaterial,boxes,andlabels)usedtocontainandpackasubstanceandtoensurecompliancewithpackingrequirements.

22

packing thephysicalactionandmethodbywhichpackagingisusedtosecurearticlesorsubstancesforshipment.

packinginstructionsIATAdefineddirectionsshippersmustfollowtoselect,assemble,mark,label,anddocumentthepackingprocessforshippingdangerousgoods,includinginfectioussubstancesincludesmanufacturingtestingandperformancespecificationsforpackagingmaterials.

pathogen amicroorganism(bacterium,mycobacterium,fungus,parasite,virus,plasmid,geneticelement,proteinaceousinfectiousparticle[prion],orgeneticallymodifiedorganism)thatisknowntocauseorisreasonablyexpectedtobeabletocausediseaseinhumansoranimals.

patientspecimenmaterialcollectedfromhumansoranimalsincludingbutnotlimitedtoexcreta,secreta,bloodanditscomponents,tissue,bodyfluids,bodyorgansandparts,andswabsofhumanmaterialbeingtransportedforpurposessuchasresearch,diagnosis,investigationalactivities,anddiseasetreatmentandprevention.

primaryspecimencontainer theinnermostpackagingcontainingadiagnosticspecimenorinfectioussubstancecomposedofglass,metal,orplasticmustbeleakproofmustbepositivelysealedifitcontainsaninfectioussubstance.

propershippingnameanyofover3,000internationallyrecognizednamesofdangerousgoodsspecificallylistedbyIATAsecondaryspecimencontainer thecontainerthatcontainstheprimaryspecimen

container.shipper anyonewhoshipsgoodsbyacommercialcarrier(usuallyanemployeeofa

companyorhealthcarefacility[e.g.,laboratorystaffmember,contractedcourier,andphysician]anyonewhooffersgoodsfortransporttoamemberofIATAanyonewhocompletesandsignstheShippersDeclaration.ThepersonwhosignstheShippersDeclarationisthepersonwhoacceptsresponsibilityfortheaccuracyoftheinformationonthedocument.

ShippersDeclarationforDangerousGoods(ShippersDeclaration) anIATAdefinedandIATAandDOTmandatedformwhichmustaccompanyeachshipmentofdangerousgoodscontainsinformationwhichdescribesthedangerousgoodsishelpfultopersonswhohandletheshipmentmustbecompletedbytheshipper.

UNcertifiedcontainer packagingmaterial(usuallyacardboardbox)thathaspassedUNmanufacturingstandardsandislabeledbythemanufacturerassuchforthetransportofcertaindangerousgoods.

UnitedStatesDepartmentofTransportation(DOT) thefederalagencywhichregulatesdomestictransportationofalldangerousgoodsintoandwithintheUnitedStatesthroughregulationspublishedintheFederalRegisterpublishesregulationswhicharebasedonandandinsubstantialagreementwithICAOregulations.

XII.APPENDIXCSelectAgentsSelectagentsaremicroorganisms,biologicalagents,orbiologicaltoxinsthathavebeendeemedbytheUnitedStatesGovernmenttobemajorthreatstopublichealthandsafetybecausetheycouldbeusedasagentsofbioterrorism.Examplesofselectagentsarethefollowing: Bacillusanthracis Yersiniapestis

23

Brucellaabortis Francisellatularensis smallpoxvirus Clostridiumbotulinumneurotoxin Coccidioidesimmitis hemorrhagicfeverviruses reconstructedreplicationcompetentformsofthe1918pandemicinfluenzaH1N1virus allagentsofbioterrorismincludingzoonoticagentsandagentsofsignificantanimaldiseases.

TheDepartmentofHealthandHumanServicesandtheDepartmentof Agriculturehavesimilarbutcertainlynotidenticallistsofselectagentsandrulesforthepossession,use,andtransferofsuchagents(1,2,3).Ifaselectagentoraspecimenoritemsuspectedofcontainingaselectagentmustbeshippedorotherwisetransportedfromonefacilitytoanother,boththeshipperandtheconsigneemustcontacttheappropriatestateandfederalauthoritiesforguidance,instructions,andpermissionbeforesuchtransferoccurs.Inaddition,theshippermustconfirmthattherecipientisapprovedforreceivingselectagents.Selectagentregulationsandalistofselectagentscanbefoundinthereferences(1,2,3,5).

24

TABLE1AgenciesGoverningTransportationofDangerousGoods

Governingauthority Agency Regulations(Reference)UnitedNations ICAOa TechnicalInstructionsfortheSafeTransport

ofDangerousGoodsbyAirCommercialairlineindustry IATAb DangerousGoodsRegulationsUnitedStates DOTc UnitedStatesHazardousMaterialsUniformSafetyActUnitedStates USPSd DomesticMailManual.CO23HazardousMaterials.Canada TransportCanada TransportationofDangerousGoodsRegulationsOthernations individualnationalregulationsaInternationalCivilAviationOrganizationb InternationalAirTransportAssociationcDepartmentofTransportationdUnitedStatesPostalService

TABLE2IATADefinedClassesofDangerousGoods

Class Substance

1 Explosives2 Gasses3 Flammableliquids4 Flammablesolids5 Oxidizingsubstancesandorganicperoxides6 Toxicandinfectioussubstances

Division6.1(toxicsubstances)Division6.2(infectioussubstancesa)

7 Radioactivematerials8 Corrosives9 Miscellaneousdangerousgoods(e.g.dryice)a

aaddressedindetailinthisprotocol

25

TABLE3

TypesandclassificationsofIATADivision6.2infectioussubstances

TypeofInfectiousSubstance IATAClassificationCategoryASubstance CategoryACategoryBSubstance CategoryBaPatientSpecimen

meetsCategoryAcriteria CategoryAmeetsCategoryBcriteria CategoryBdoesnotmeetCategoryAorBcriteria ExemptHumanorAnimalSpecimen

ExemptHumanorAnimalSpecimen ExemptHumanorAnimalSpecimenGeneticallyModifiedMicroorganism

meetsCategoryAcriteria CategoryAmeetsCategoryBcriteria CategoryBdoesnotmeetCategoryAorBcriteria GeneticallyModifiedOrganism

ExemptSubstance noneBiologicalProductbInfectedAnimalbMedicalWasteb

a TheonlyacceptablepropershippingnameforCategoryBsubstancesisBiologicalSubstance,CategoryB.ThepropershippingnamesDiagnosticSpecimenandClinicalSpecimen arenolongerallowed.

bsubstanceisnotaddressedindetailinthisprotocol

26

TABLE4ExamplesofinfectioussubstancesincludedinCategoryAinanyformunlessotherwise

indicated

UNNumberandProperShippingName Organism

UN2814InfectiousSubstance,AffectingHumans

Bacillusanthracis (culturesonly)Brucellaabortus (culturesonly)Brucellamelitensis (culturesonly)Brucellasuis (culturesonly)Burkholderiamallei (culturesonly)Burkholderiapseudomallei (culturesonly)Chalamydiapsittaci (avian)(culturesonly)Clostridiumbotulinum (culturesonly)Coccidioidesimmitis (culturesonly)Coxiellaburnetii (culturesonly)CrimeanCongohemorrhagicfevervirusdenguevirus(culturesonly)easternequineencephalitisvirus(cultureonly)Escherichiacoli,verotoxigenic(culturesonly)EbolavirusFrancisellatularensis (culturesonly)hantavirus(causinghemorrhagicfeverwithrenalsyndrome)hantaanvirushepatitisBvirus(culturesonly)herpesBvirus(culturesonly)humanimmunodeficiencyvirus(culturesonly)lassavirusmarburgvirusmonkeypoxvirusMycobacteriumtuberculosis(culturesonly)poliovirusvirus(culturesonly)rabiesvirus(culturesonly)Rickettsiarickettsii (culturesonly)RiftValleyfevervirus(culturesonly)Shigelladysenteriaetype1(culturesonly)variolavirusVenezuelanequineencephalitisvirus(culturesonly)WestNilevirus(culturesonly)yellowfevervirus(culturesonly)Yersiniapestis(culturesonly)

Tablecontinuesonnextpage

27

UN2900InfectiousSubstance,AffectingAnimals

Table4continued

classicalswinefevervirus(culturesonly)footandmouthdiseasevirus(culturesonly)goatpoxvirus(culturesonly)lumpy skindiseasevirus(culturesonly)Newcastlediseasevirus(culturesonly)sheeppoxvirus(culturesonly)swinevesiculardiseasevirus(culturesonly)vesicularstomatitisvirus(culturesonly)

28

TABLE5InformationprovidedforeachpropershippingnameintheIATAalphabeticalListofDangerousGoodsandapplicabletocompletingaShippersDeclaration

Columna InformationA UnitedNationsIDnumberofthepropershippingname/descriptionB propershippingname/descriptionC classordivisionofdangerousgoodD N/AbE thehazardouslabelrequiredontheouterpackageF N/AG N/AH N/AI packinginstructionstouseforpassengerandcargoaircraftJ maximumallowableamountstobeshippedin passengerandcargoaircraftK packinginstructionstouseforcargoaircraftonlyL maximumallowableamountstobeshippedin cargoaircraftonlyM applicablespecialprovisionsandexceptionsN emergencyresponsecode

a referstothe14columnsintheIATAalphabetical ListofDangerousGoodsbnotapplicabletoinfectioussubstances

29

TABLE6Theseven typesofinfectioussubstancesintheIATAalphabetical ListofDangerousGoods

PassengerorCargoAircraftCargoAircraft

LtdQuantity Only

UNIDNumber

ProperShippingName/Description Class

SubRisk

HazardLabel(s)

PkGp

PkInst

MaxNetQty/Pkg

PackInst

MaxNetQty/Pkg

PackInst

MaxNetQty/Pkg

SpecProv

ERGCode

A B C D E F G H I J K L M N2814 Infectioussubstance,

affectinghumansa(liquid)

6.2 infectioussubstance

602 50mL 602 4L A81A140

11Y

2814 Infectioussubstance,affectinghumansa(solid)

6.2 infectioussubstance

602 50g 602 4kg A81A140

11Y

2900 Infectioussubstance,affectinganimalsonlya(liquid)

6.2 infectioussubstance

602 50mL 602 4L A81A140

11Y

2900 Infectioussubstance,affectinganimalsonlya(solid)

6.2 infectioussubstance

602 50g 602 4kg A81A140

11Y

3373 Biologicalsubstance,categoryB

none 650 4L/4kg 650 4L/4kg 6L

3245 Geneticallymodifiedmicroorganisms

9 miscellaneous 913 nolimit 913 nolimit A47 9L

1845 Dryiceb 9 miscellaneous III 904 200kg 904 200kg A48 9LaOntheShippersDeclaration(butnotontheouterpackage),thepropershippingnameofthesubstancemustbefollowedbythetechnicalname(inparentheses)ofthesubstance,e.g.,InfectiousSubstance,AffectingHumans(Mycobacteriumtuberculosis).

b notaninfectioussubstancebutrelevanttothisprocedure

30TABLE7

Comparisonof IATAandDOTPackingRequirementsforInfectiousSubstances

Substance

PackingRequirement ExemptHumanSpecimensa

CategoryBb CategoryAc

InnerContainersleakproofprimary(1o)andsecondary(2o)containers yes yes yespressureresistant1oor2ocontainer d yes yesabsorbentbetween1oand2ocontainerse yes yes yeslistofcontentsbetween2oandouterpackage yes yespositivelysealed1ocontainer no yes

OuterContainerrigidouterpackaging yes yesstrictmanufacturingspecifications nonef few manynameandnumberofresponsibleperson yesg yesmarkingsandlabels yesh Less more

QuantityLimitsforEitherPassengerorCargoAircraftmaximumforeach1ocontainer 1L(1kg) 50mL(50g)totalmaximumforouterpackage 4L(4kg) 50mL(50g)

DocumentationShippersDeclarationforDangerousGoods no yesemergencyresponsetelephonenumber no yes

Costscostoflaborandmaterialstopacksubstance least more most

apackingdirections(IATA andDOTprovideonlyminimalstandards[i.e.,nodetailedandnumberedpackinginstructions]forpackingandshippingExemptHumanSpecimens.)

bpackinginstructions650cpackinginstructions602drequirementnotspecifiedbyIATAorDOTenotrequiredforsolidsubstancessuchastissueandsolidagarmediaculturesorslantf shouldbeofadequatestrengthforitsintendedcapacity,mass,andintendeduse(IATAquote)gmaybeplacedeitherontheouterpackageorontheairwaybillhOnlyExemptHumanSpecimenorExemptAnimalSpecimenisrequired.

31

FIGURE1 AlgorithmforClassifyingInfectiousStances

CategoryBInfectiousSubstance

(UN3373)

InfectiousSubstanceBeingShipped

ExemptSubstance

pathogenonCatA listandinappropriateform orsuspectedCatA pathogen orbeingtestedforCatA orhascharacteristicsofCatA orcannotruleoutCatA oruncertainifCatA orCatB orconsideredahealthrisktocarrierpersonnel

ExemptHumanorAnimalSpecimen

BiologicalSubstance doesnotcontaininfectioussubstance containsinactorneutpathogens containsnonpathogenicorganisms environmentalsample driedbloodspots fecaloccultbloodspecimen decontaminatedmedicalwaste tobeusedfortransplantortransfusion

CategoryAInfectiousSubstance(UN2814orUN2900)

PatientSpecimenorOtherSubstance(professionaljudgementrequired)

likelytocontainorbeingtestedforpathogen orhasreasonablepotentialtocausediseaseinhumansoranimals

PatientSpecimen(professionaljudgementrequiredifunabletomakeprofessionaljudgement,considerCatAorCatB)

fortestsnotrelatedtoaninfectiousdisease ornoreasontosuspectthespecimenisinfectious orunlikelytocausediseaseinhumansoranimals ordoesnotcontain,hasminimallikelihoodofcontaining,orisnotbeingtestedforpathogens

YES NO

32

FIGURE2 Labelswhichindicatean infectioussubstance(Class6),propershippingname,UNnumber,andquantityofsubstance.

FIGURE3 LabelswhichindicateaBiologicalSubstance,CategoryBandappropriateUNnumber.

InfectiousSubstance,AffectingHumansUN28144mL

BiologicalSubstance,CategoryB

UN3373

33

FIGURE4 Labelswhichindicateamiscellaneous(Class9)dangerousgood(2kgofdryice).

FIGURE5 Labelwhichindicatescorrectorientationofpackageduringshipping.

FIGURE6 Labelwhichindicatessubstancemustbetransportedonlyincargo(notpassenger)aircraft.

DryIce

2kg

Danger!DONOTLoadinPassengerAircraft

34

FIGURE7 Labelwhichindicatesan overpackisusedandinnerpackagescomplywithregulations.

FIGURE8 LabelwhichindicatesanExemptHumanSpecimen

FIGURE9 ExampleofalabelwhichindicatesoutercontainerhasmetUNspecifiedmanufacturingstandards

OVERPACK

ExemptHuman

Specimen

4G/CLAS6.2/2004

CAN/82AIRPACK

UN

35

FIGURE10 Exampleofanappropriatelylabeledouterpackage.TheprimarycontainerinsidethepackagecontainsanExemptHuman SpecimenandispackedaccordingtoIATAinstructions.

Consignee

Shipper

ExemptHuman

Specimen

36

FIGURE11 Acompletelylabeledouterpackage.TheprimarycontainerinsidethepackagecontainsaBiologicalSubstance,CategoryBsubstanceandispackedaccordingtoPI650.

Consignee

Shipper

UN3373

BiologicalSubstance,CategoryB

ResponsiblePersonandPhoneNumber

DryIce3kg

37

FIGURE12Acompletelylabeledouterpackage.TheprimarycontainerinsidethepackagecontainsaCategoryAinfectioussubstanceandispackedaccordingtoPI602.

Consignee

Shipper

ResponsiblePerson&PhoneNumber

ProperShippingName,UNNumber,&Quantity

4G/CLASS6.2/2007

CAN/82AIRPACK

UN

DryIce3kg

38

FIGURE13 ShippersDeclarationforDangerousGoodsand13sectionswhichmustbecompletedbytheshipper.

name,address,andlogoofcompany(optional)

1

5

6

2

43

9

8

7

a b c d e f g

11

10

13

12

39

FIGURE14 CompletedShippersDeclarationforDangerousGoods.

WilkinsLaboratoriesClinicalMicrobiologyServices

UNInfectioussubstance,6.22mL6022814affectinghumans

(Mycobacteriumtuberculosis)

JohnE.Wilkins,Director

Pacolet,SCOctober29,2005

John E. Wilkins

UNDryice9III4kg9041845

packedinasinglecardboardbox

WilkinsLaboratories1970TarheelAvenuePacolet,SC27105

Dr.WilliamTruitt7ElephantsFootTrailCharlotte,NC45227

ResponsiblePersonandNumber:JanetIrwin(919)2715432

EmergencyContact:(800)7451122

11