sentinel laboratory guidelines for suspected...
TRANSCRIPT
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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.
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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.
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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.
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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
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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.
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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
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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).
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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
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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
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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
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UN2900InfectiousSubstance,AffectingAnimals
Table4continued
classicalswinefevervirus(culturesonly)footandmouthdiseasevirus(culturesonly)goatpoxvirus(culturesonly)lumpy skindiseasevirus(culturesonly)Newcastlediseasevirus(culturesonly)sheeppoxvirus(culturesonly)swinevesiculardiseasevirus(culturesonly)vesicularstomatitisvirus(culturesonly)
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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
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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
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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.
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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
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FIGURE2 Labelswhichindicatean infectioussubstance(Class6),propershippingname,UNnumber,andquantityofsubstance.
FIGURE3 LabelswhichindicateaBiologicalSubstance,CategoryBandappropriateUNnumber.
InfectiousSubstance,AffectingHumansUN28144mL
BiologicalSubstance,CategoryB
UN3373
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FIGURE4 Labelswhichindicateamiscellaneous(Class9)dangerousgood(2kgofdryice).
FIGURE5 Labelwhichindicatescorrectorientationofpackageduringshipping.
FIGURE6 Labelwhichindicatessubstancemustbetransportedonlyincargo(notpassenger)aircraft.
DryIce
2kg
Danger!DONOTLoadinPassengerAircraft
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FIGURE7 Labelwhichindicatesan overpackisusedandinnerpackagescomplywithregulations.
FIGURE8 LabelwhichindicatesanExemptHumanSpecimen
FIGURE9 ExampleofalabelwhichindicatesoutercontainerhasmetUNspecifiedmanufacturingstandards
OVERPACK
ExemptHuman
Specimen
4G/CLAS6.2/2004
CAN/82AIRPACK
UN
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FIGURE10 Exampleofanappropriatelylabeledouterpackage.TheprimarycontainerinsidethepackagecontainsanExemptHuman SpecimenandispackedaccordingtoIATAinstructions.
Consignee
Shipper
ExemptHuman
Specimen
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FIGURE11 Acompletelylabeledouterpackage.TheprimarycontainerinsidethepackagecontainsaBiologicalSubstance,CategoryBsubstanceandispackedaccordingtoPI650.
Consignee
Shipper
UN3373
BiologicalSubstance,CategoryB
ResponsiblePersonandPhoneNumber
DryIce3kg
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FIGURE12Acompletelylabeledouterpackage.TheprimarycontainerinsidethepackagecontainsaCategoryAinfectioussubstanceandispackedaccordingtoPI602.
Consignee
Shipper
ResponsiblePerson&PhoneNumber
ProperShippingName,UNNumber,&Quantity
4G/CLASS6.2/2007
CAN/82AIRPACK
UN
DryIce3kg
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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
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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