Shipping Biological Materials - Environmental Health & Safety

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Shipping Biological Materials - Environmental Health & Safety

UNIVERSITY OF OREGONEnvironmental Health and SafetyUO Shipment ofBiological Materials ManualRevised 01/2013


Table of ContentsI. Introduction 4II. Training Requirements 4III.Shipping Overview 5IV. Shipment Classification 6V. Packaging Requirements 8VI. Marking and Labeling Requirements 11VII. Shipping Documentation 15VIII. Select Agents 16IX. International Shipments 17Appendix A – Materials known to be Category A Infectious Substances 23Appendix B – Manufacturers of Certified Shipping Containers for InfectiousSubstances, Diagnostic Specimens & Dry Ice 24Appendix C – Example Shipper’s Declaration for Dangerous Goods 25Appendix D – Intent to Ship Hazardous Materials 26Appendix E – APHIS Plant Pathogens, HHS Select Infectious Agents & USDA HighConsequence Livestock Pathogens/Toxins 27Appendix F – Additional HHS and USDA Select Agent/High Consequence PathogenExemptions 293


I. IntroductionThe Office of Environmental Health and Safety (EHS) has provided this manual toassist in the shipment of biological materials. This document includes informationabout how to properly classify, package, mark and label your shipment. This manualalso describes the training requirements necessary to ship biological materials.In order to provide for safe carriage and protection of the general public, shippedbiological specimens, infectious agents and other biological materials are regulated bygovernmental and non-governmental consensus development organizations,including:• International Air Transport Association (IATA) – domestic & international.• US Department of Transportation (DOT) – US surface transport.• US Public Health Service (PHS).• Occupational Health and Safety Administration (OSHA).• United States Postal Service (USPS).Penalties for non-compliance with rules are significant, including:• Up to $250,000 and up to a year jail sentence for individuals.• Up to $500,000 per incident for organizations.Transportation of infectious substances and other dangerous goods by air also requiresstrict adherence to Transportation and Security Administration (TSA) regulations.Carrying dangerous goods by hand, for example in a vial in your pocket or in luggage,is strictly prohibited. TSA regulations cover your checked luggage, materials you carryon, or materials you carry in your pockets when you board an airplane. Persons whoviolate these regulations are subject to fines and criminal prosecution.IATA regulations are commonly encountered since they regulate materials transportedby air and are generally the most restrictive with respect to commercial shipping. Forthese reasons, this guide pays special attention to IATA protocols.II.Training RequirementsFederal rules require that anyone involved in the shipment of biological materialsmust first have hazardous materials transportation training. If you are going topackage biological materials for shipment, prepare shipping documentation, acceptpackages for shipment, or supervise these activities, then you must follow the trainingcertification requirements outlined below.1. Read this manual. This manual will provide familiarity with the generalprovisions relating to the regulations and detailed training in therequirements applicable to shipping biological materials.2. If shipping human source material, Bloodborne Pathogen training fromEHS must be current. This training ensures that you are familiar with:4


hazards presented by infectious materials; proper handling; andemergency response procedures.3. Submit to EHS: Intent to Ship Hazardous Materials form (Appendix D).EHS will review this form with you and, upon successful completion, willcertify you to ship only those materials that are listed on your Intent form.Shipping regulations change frequently so it is necessary to repeat trainingcertification every two years. Training sessions reviewing the material in this manualare available from EHS. Call EHS at 346-3192 to schedule training or to ask questionsregarding the shipment of biological materials.III. Shipping OverviewFollow these basic steps when shipping biological materials. See Figure 1 to quicklyvisualize steps 1 and 2.1. Classify your materials for shipment. See Section IV.2. Package, mark, and label your material(s) appropriately. See Section V &VI.3. Fill out shipping documentation. See Section VII.4. If you are shipping Select Agents, special regulations apply. ConsultSection VIII.5. If you plan on importing or exporting biological materials (internationalshipments), special regulations apply. Consult Section IX.Figure 1Pathogens neutralized/Inactivated? Known not to contain infectioussubstances? All microorganisms present non-pathogenic to humans/animals? Adried blood spot/faecal occult blood? Environmental samples (e.g. food/water)not considered to pose significant health risk? A sample for transplant/infusion?No to AllYES to AnyMeets definition of Category A substances?GeneticallyModifiedMaterial?YESYESNoNoPatient Specimen with minmal likelihood of pathogens being present?Class 6.2UN 2814. Infectious Substance,affecting humans. PI 620.UN 2900. Infectious Substances,affecting animals. PI 650.NoClass 6.2UN 3373. BiologicalSubstance, Category B.PI 650.YESExemptHuman orAnimalprovisions.Notsubject tobiologicalDGR.Triplepackagingapplies.Class 9UN 3245.GeneticallyModifiedOrganism(s).PI959.5


IV.Shipment ClassificationFor shipment purposes, biological materials are categorized into the following classes:• Infectious Substances, Category A.• Biological Substances, Category B.• Patient Specimens.• Genetically Modified Materials.• Biological products.• Exempted materials not subject to Dangerous Goods Regulations (DGR).Read each section carefully to determine which class your material falls into.Remember that the regulations allow a certain amount of professional judgment whenclassifying biological materials for shipment. Also remember that other hazardousmaterials present (e.g. dry ice, liquid nitrogen, flammable or toxic preservatives, etc.)will be regulated under dangerous goods provisions not fully explained in thismanual – refer to dry ice and hazardous materials shipment manuals as needed.Whenever you are not certain how to classify a material for shipment, contact EHS at541-346-3192.A. Infectious Substances, Category AInfectious substances are materials known to be, or are reasonably suspected tocontain, an animal or human pathogen. A pathogen is a virus, microorganism(including bacteria, plasmids, or other genetic elements), proteinaceousinfectious particle (prion) or recombinant microorganism (hybrid or mutant) thatis known or reasonably expected to cause infectious disease in humans oranimals.Infectious substances are divided into two categories, Category A and CategoryB. Either category may include:• Cultures.• Patient Specimens (human or animal).• Biological products.• Genetically modified organisms and microorganisms.Category designations are the result of evaluating scientific data on risks oftransmission and infection posed by each species of organism. Category Asubstances are capable of causing permanent disability, life-threatening or fataldisease in otherwise healthy humans or animals. Substances known to meetthese criteria are listed in Appendix A.B. Biological Substances, Category BInfectious substances that do not meet the criteria for inclusion in Category A arereferred to as Biological Substances.6


C. Patient SpecimensPatient specimens are materials, collected directly from humans or animals, forresearch, diagnosis, disease treatment and prevention, or investigationalpurposes that may contain, or be suspected of containing pathogens. Patientspecimens can include human or animal tissue samples, blood, excreta, secreta,tissue and tissue fluid swabs, etc.Patient specimens must be shipped as an Infectious Substance when “the sourcepatient or animal has or may have a serious human or animal disease which canbe readily transmitted from one individual to another, directly or indirectly, andfor which effective treatment and preventative measures are not usuallyavailable.” A list of microorganisms that may not be classified as patientspecimens is provided in Appendix A.D. Genetically Modified Organisms (GMO) and Microorganisms (GMMO)All genetically modified organisms or microorganisms are regulated fortransportation. A genetically modified organism or microorganism that meets thedefinition of an infectious substance must be classified as an infectioussubstance for transportation. For these materials, follow instructions for shippingan infectious substance.Live animals that are genetically modified, or contain or are contaminated withgenetically modified organisms or microorganisms that meet the definition of aninfectious substance can only be shipped under specific terms and conditions ofthe appropriate national authorities of the States of origin and destination.Genetically modified organisms and microorganisms which are not toxic orinfectious substances are assigned to the category of Genetically ModifiedOrganisms or Genetically Modified Microorganisms, UN 3245.E. Biological ProductsBiological products are biological materials used in the prevention, diagnosis,treatment or cure of diseases in humans or animals and are certified by theUSDA or FDA. Examples of biological products include certain viruses,therapeutic serums, toxins, antitoxins, vaccines, blood, and blood products.Biological products transported for final packaging, distribution, and use bymedical professionals are not subject to biological shipping regulations.F. Exempted Materials not subject to Dangerous Goods Regulations (DGR)Some biological materials are exempt from dangerous goods regulations,however even exempted materials MUST be packaged according to the triplepackaging concept and labeled “Exempt Specimen”. Exempted materialsinclude:• Non-infectious biological materials from humans, animals, or plants.o Non-infectious cells, cell lines, or cultures.7


performance standards. Containers purchased from commercial vendors aredesigned to meet the necessary standards. If you are shipping any liquid, theremust be enough absorbent material in the secondary container to absorb all ofthe liquid in the primary receptacle(s). If multiple primary containers are used,they must be wrapped to prevent contact between them so they do not breakduring transport.• The outer container must have one side that is at least 100 mm X 100 mm, inorder for required markings and labels to fit. The outer package must be ofadequate strength for its capacity, mass, and intended use. An itemized list ofpackage contents must be included between the outer and secondary container.The outer package should be marked to identify hazardous contents, includingthe proper shipping name, UN number and net quantity for each substance.Shipping vendors (see Appendix B) will assist you when purchasing packaging.When ordering specify the category of the material you will be shipping.A. Infectious Substances, Category AMaterials in this category must be packaged according to IATA PackingInstruction 620. Either primary or secondary container must be UNspecification, and both primary and secondary containers must be from the samemanufacturer• Primary container – water tight & labeled.• Secondary container – water tight, labeled, absorbent material sufficient toabsorb the entire contents of the secondary container, and if housingmultiple primary containers each must be sufficiently separated fromothers to prevent contact or breakage.• Rigid outer container – UN Specification, contains an itemized contentslist, and complies with maximum quantity limitations:o 4L or 4kg of material if shipped by cargo aircraft.o 50mL or 50g of material if shipped by passenger aircraft.B. Biological Substances, Category BMaterials in this category must be packaged according to IATA PackingInstruction 650. UN specification packaging is not required provided contentssurvive a 1.2 meter drop test fully intact.• Primary container – water tight & labeled.• Secondary container – water tight, labeled, absorbent material sufficient toabsorb the entire contents of the secondary container, and if housingmultiple primary containers each must be sufficiently separated fromothers to prevent contact or breakage.• Rigid outer container – contains an itemized contents list, and complieswith maximum quantity limitations:o 4L or 4kg of material (passenger, or cargo, aircraft).o 100mm x 100mm (4in x 4in) minimum dimensions.9


C. Patient SpecimensMaterials in this category require packaging that prevents any leakage ofcontents, and marking indicating “Exempt Human Specimen”, or “ExemptAnimal Specimen”, as appropriate.• Primary container – water-tight and labeled.• Secondary container – water tight, labeled, absorbent material sufficient toabsorb the entire contents of the secondary container, and if housingmultiple primary containers each must be sufficiently separated fromothers to prevent contact or breakage.• Rigid outer container – labeled as appropriate, primary containers notgreater than 500mL or 500g, package contents not greater than 4L or 4 kg,and 100mm x 100mm (4in x 4in) minimum dimensions.D. Genetically Modified Organisms and MicroorganismsMaterials meeting criteria for Infectious Substances category A, or BiologicalSubstances category B, must be packaged according to those requirements.Other genetically modified materials are packaged according to IATA PackingInstruction 959.• Primary container – water-tight and labeled.• Secondary container – water tight, labeled, absorbent material sufficient toabsorb the entire contents of the secondary container, and if housingmultiple primary containers each must be sufficiently separated fromothers to prevent contact or breakage.• Rigid outer container – labeled as appropriate, and 100mm x 100mm (4inx 4in) minimum dimensions.E. Biological ProductsThese materials are not regulated as dangerous goods, but triple packaging suchas indicated for GMO’s and GMMO’s should be used.F. Exempted Materials not subject to Dangerous Goods Regulations (DGR)Exempted materials are packaged in accordance with guidelines for PatientSpecimens.G. Packaging requirements for Dry Ice, Liquid Nitrogen, Liquid Nitrogen DryShippers, and Overpacks• Dry Ice – Packaging Instruction 954. Packaging must allow sublimingvapor to not build pressure. See UO guidance manual on shipping dryice, and labeling summary described within the section on Marking andLabeling Requirements.• Liquid Nitrogen (free liquid) – Packaging Instruction 202, UN1977“Nitrogen, refrigerated liquid”. See UO guidance manual on shippinghazardous materials.10


• Liquid Nitrogen in Dry Shipper – When fully absorbed within specificporous “dry shipper” packaging liquid nitrogen is not subject to DGRother than notification on airbills as described in the section on ShippingDocumentation.• Overpacks – Overpacks may be used to combine several individuallytriple-packed packages into one large package. The overpack must bearthe same markings and labelings as the individual packages within, andmust bear the word “Overpack”.VI.Marking and Labeling RequirementsA. Infectious Substances, Category ARequired Labels:• “This End Up” on two sides.• UN specification printed on box by packaging manufacturer.• Dry Ice, or Liquid Nitrogen, labeling – if present. See Figure 2.• Infectious Substance label. See Figure 3.• Cargo Only label when shipping > 50mL or 50g of material. See Figure 4.Required Markings:• Sender’s/Recipients full name, address, & telephone number.• Proper shipping name, UN number, and net quantity of infectioussubstance.• Name and telephone number of the person responsible for the shipment.Additional labels and markings needed if packaged with Dry Ice or LiquidNitrogen. See guidance on Dry Ice and Liquid Nitrogen.B. Biological Substances, Category BRequired Markings:• Sender’s/Recipients full name, address, & telephone number.• “Biological Substances, Category B” (letters must be >6mm tall) adjacentto UN label.• Name and telephone number of the person responsible for the shipment.Additional labels and markings needed if packaged with Dry Ice or LiquidNitrogen. See guidance on Dry Ice and Liquid Nitrogen.11


C. Patient SpecimensRequired Markings:• Sender’s/Recipients full name, address, & telephone number.• “Exempt human specimen”, or “Exempt animal specimen”.Additional labels and markings needed if packaged with Dry Ice or LiquidNitrogen. See guidance on Dry Ice and Liquid Nitrogen.D. Genetically Modified Organisms and MicroorganismsRequired Labels:• UN3245 label.Required Markings:• Sender’s/Recipients full name, address, & telephone number.Additional labels and markings needed if packaged with Dry Ice or LiquidNitrogen. See guidance on Dry Ice and Liquid Nitrogen.E. Biological Products and Exempted Materials not subject to DGRRequired Markings:• Sender’s/Recipients full name, address, & telephone number.Additional labels and markings needed if packaged with Dry Ice or LiquidNitrogen. See guidance on Dry Ice and Liquid Nitrogen.F. Dry IceRequired Labels:• Class 9 label (Figure 2).Required Markings:• UN number and amount of dry ice in kilograms.o “UN 1845 Dry Ice ___ kg”Triple Packaging Category A Infectious Substances12


Examples of Marking and Labeling follow (with and without Dry Ice):From: shipperTel. #TTo: consigneeInfectious SubstanceAffecting Humans(Hepatitis B virus)UN2814 Net Qty 30mlFrom: shipperTel. #To: consigneeInfectious SubstanceAffecting Humans(Hepatitis B virus)UN2814 Net Qty 30mlTel. #Dry Ice, UN1845Net Weight: 3kgTel. #Responsible PersonResponsible PersonName, Tel. #Name, Tel. #From: shipperTel. #Biological substance,category BFrom: shipperTel. #Biological substance,category BTo: consigneeDry Ice, UN1845Net Weight: 3kgTo: consigneeTel. #Tel. #Responsible PersonResponsible PersonName, Tel. #Name, Tel. #From: shipperTel. #“Exempt HumanSpecimen”, or “ExemptAnimal Specimen”From: shipperTel. #“Exempt HumanSpecimen”, or “ExemptAnimal Specimen”To: consigneeDry Ice, UN1845Net Weight: 3kgTo: consigneeTel. #Tel. #13


Biological Products:From: shipperTel. #From: shipperTel. #To: consigneeTel. #Dry Ice, UN1845Net Weight: 3kgTo: consigneeTel. #Genetically Modified Organisms or Microorganisms:From: shipperTel. #From: shipperTel. #To: consigneeTel. #Dry Ice, UN1845Net Weight: 3kgTo: consigneeTel. #14


VII. Shipment DocumentationShipping documentation is required so that transporters, and handlers, are aware ofthe nature of the goods they are transporting, how to load and handle, and necessaryactions if an accident were to result in the release of package contents. Requireddocumentation may include Bills of Lading, Air Waybills, and Declarations ofDangerous Goods. Improperly completed shipping documentation is the mostcommon cause of package refusal. Summaries of requirements of Air Waybills andDeclarations of Dangerous Goods follows:A. Air WaybillInfectious Substance, Category A• Handling Information must indicate “Dangerous Goods per attachedShipper’s Declaration for Dangerous Goods”, or “Dangerous Goods perattached Shipper’s Declaration for Dangerous Goods Cargo Aircraft Only”.Biological Substance, Category B• Name, address, and phone number of Responsible Person must be listed.• Dry Ice (if present) must be listed as “Dry Ice UN1845 __kg”• Goods must be described as “Biological Substance, Category B UN3373”.Patient Specimens• Goods must be described as either “Exempt human specimen” or “Exemptanimal specimen”.Dry Ice• Goods must be described as “Dry Ice UN1845 __kg”.Dry Shipper (containing liquid nitrogen)• Goods must be described as “not restricted, A152”.Liquid Nitrogen (not in dry shippers)• Goods must be described as “Nitrogen, refrigerated liquid UN1977”.B. Declaration of Dangerous GoodsAll persons completing declaration of dangerous goods must be trained on theapplicable regulation. Consult EHS for assistance.1. Shipper: Enter your full name, address and telephone number.2. Consignee: Enter full name and address of recipient. When shippinginfectious substances, include the text, “Person responsible for theshipment,” followed by your name and phone number.3. Transport Details: Indicate here if your shipment is restricted to cargoaircraft only (if it is more than 50 ml or 50 g of an infectioussubstance). Airport of departure and airport of destination will befilled out by the carrier, leave blank.15


4. Shipment Type: Cross out “radioactive” to indicate you are shippinga non-radioactive substance.5. Proper Shipping Name: Enter the proper shipping name exactly as itappears in Table 1.6. Class or Division: Enter appropriate hazard class as found in Table 1.7. UN or ID Number: Enter appropriate UN number as found in Table 1.8. Packing Group: For dry ice, enter “III” in this column. Biologicalmaterials are not assigned packing groups.9. Subsidiary Risk: Leave this column blank.10. Quantity and Type of Packaging: Enter the net quantity for eachmaterial here. Use only metric units. At the bottom of this column,indicate the number and type of packages used. If using an overpack,indicate here with “Overpack Used.”11. Packing Instructions: Enter appropriate packing instruction number.Refer to Table 1.12. Authorization: Leave this column blank.13. Additional Handling Instructions: Two statements are required inthis section:1) The statement “Emergency Contact: ChemTrec 1-800-424-9300.” UO has an annual contract with ChemTrec toprovide 24-hour emergency telephone response service.2) When shipping infectious substances, include thestatement “Prior arrangements as required by the IATADangerous Goods Regulations 1.3.3.1 have been made.”14. Signature and date.A filled example of a Shipper’s Declaration for Dangerous Goods is available inAppendix C. Please note the following:• Declarations must be typewritten or computer-generated; handwrittendeclarations will not be accepted.• Remember to sign each copy.• Always print at least four copies: provide three to the carrier and keep one foryour records.• Regulations require that you must retain your copy for two years.VIII. Select AgentsThe U.S. Department of Health and Human Services has developed a list of biologicalagents (see Appendix E and Appendix F) that have the potential to pose a severethreat to public health. Special regulations apply to the use and transfer of thesematerials, including registration with the UO Institutional Biosafety Committee andthe Centers for Disease Control and Prevention and/or the Department of Agriculture.If you are planning to, or currently work with, any of the select agents listed below16


and have not registered, contact Laboratory or Bio Safety Officer at 346-3192. Specificshipping restrictions apply to these agents which are not discussed in this document.IX.International ShipmentsShipping and receiving animals and animal-derived materials, infectious orbiohazardous agents, biological toxins, and genetically modified organisms mayrequire the approval of federal agencies, both domestic and foreign. Regulations thatgovern the transfer of biological materials help to minimize or eliminate the possiblethreats to public health and agriculture.Packages shipped internationally generally require increased preparation time due tothe additional paperwork required for such packages. An import/export permit maybe required when shipping biological materials internationally. Check the followingU.S. governmental agencies for permits and additional information:APHIS Agricultural Permits[ http://aphisweb.aphis.usda.gov/ppq/permits/ ]Telephone: 1-877-770-5990APHIS permits are required to import or domestically transfer a plant pest, plant biological agent, or other material listed below.EXPORT/IMPORT• Arthropods (insects and mites)• Arthropods inhabiting dung or of medical/veterinary significance• Bees and bee related articles• Biological materials containing animal material• Butterflies• Cell cultures of bovine or other livestock origins• Cut flowers• Earthworms• Endangered species• Endangered species of wild fauna and flora• Entomopathogens• Farm animals• Foreign cotton and covers• Fruits and vegetables• High consequence livestock pathogens and toxins• Indian corn or maize, broomcorn and related plants• Infectious agents of livestock• Khapra beetle products• Live arthropods for display or educational purpose• Livestock• Moths• Noxious weeds• Nursery stocks (including seeds)• Parasitic plants• Plant pathogens• Predators and parasitoids of arthropods• Prohibited material for research purposes• Rice and rice related articles• Seeds• Snails and slugs• Soil• Sugarcane products and by-products (including parts of thesugarcane plant)• Tissue culture materials of bovine or other livestock origins• Weed biocontrol• Wildlife• Wood products17


CDC Permit to Import or Transport Agents or Vectors of Human Disease[ http://www.cdc.gov/od/ohs/biosfty/imprtper.htm]Telephone: 1-404-498-2260CDC permits are required when shipping any infectious agent known or suspected to cause disease in humans, unsterilizedspecimens of human or animal tissues (including blood and other fluids), or biological vectors of infectious animals, bats, insects,arthropods and snails.INFECTIOUS SUBSTANCES• It is impractical to list all of the several hundred species of infectious substances. In general, an import permit is needed for anyinfectious substance known or suspected to cause disease in man.BIOLOGICAL MATERIALS• Unsterilized specimens of human and animal tissues (such as blood, body discharges, fluids, excretions or similar material) containing aninfectious agent requires a permit in order to be imported.VECTORS• Animals: Any animal known or suspected of being infected with an organism capable of causing disease transmissible to man mayrequire a CDC permit. Importation of live turtles of less than 4 inches in shell length and all nonhuman primates requires animportation permit issued by the Division of Quarantine.• Bats: All live bats require an import permit from the CDC and the U.S. Department of Interior, Fish and Wildlife Services.• Insects or Arthropods: All live fleas, flies, lice, mites, mosquitoes, or ticks require a CDC import permit, regardless of infection status.Permits are required for adult forms, as well as eggs, larvae, pupae, and nymph stages. Any other living insect or arthropod, known orsuspected of being infected with any disease transmissible to man requires a CDC import permit.• Snails: Any snail species capable of transmitting a human pathogen require a permit from the Centers for Disease Control.FDA Import Permits[ http://www.fda.gov/ora/import/ ]All food (except most meat and poultry), drugs, biologics, cosmetics, medical devices, and electronic products that emit radiationrequire a permit or registration before importation into the United States.Fish and Wildlife Service Permit Station[ http://international.fws.gov/permits/permits.html]Telephone: 1-800-770-0150A permit may be required for transporting fish, wildlife, endangered species, or materials found in the list below.EXPORT• African elephant ivory• Animals• Artificially propagated plants• Asian elephant ivory• Biological samples• Captive-born export• Circuses/traveling animal exhibitions• GoldensealIMPORT• African elephant• African elephant ivory• African leopard• Argali• Asian elephant ivory• Biological samples• Birds• Bontebok• Circuses/traveling animal exhibitions• Ginseng• Marine mammals• Museum specimens• Personal pet• Plants• Raptors• Trophies by taxidermist• Wildlife• Marine mammals• Museum specimens• Personal pet• Plants• Polar bears• Scientific and zoological breeding or display• Sport hunted trophy• White rhinoceros• Wildlife18


U.S. Commerce Department – Bureau of Industry and Security (BIS)[ http://www.bis.doc.gov/index.htm]A permit may be required from the Commerce Department, when exporting infectious agents of human, plant, and animaldiseases, including genetic material, and products which might be used for culture of large amounts of agents.HUMAN PATHOGENS and TOXINSRickettsiaeViruses• Bartonella quintana (Rochalimea quintana, Rickettsia quintana)• Coxiella burnetii• Rickettsia prowasecki• Rickettsia rickettsiaBacteria• Bacillus anthracis• Brucella abortus• Brucella melitensis• Brucella suis• Burkholderia mallei (Pseudomonas mallei)• Chikungunya virus• Congo-Crimean haemorrhagic fever virus• Dengue fever virus• Eastern equine encephalitis virus• Ebola virus• Hantaan virus• Japanese encephalitis virus• Junin virus• Lassa fever virus• Lymphocytic choriomeningitis virus• Burkholderia pseudomallei (Pseudomonas pseudomallei)• Machupo virus• Chlamydia psittaci• Marburg virus• Clostridium botulinum• Monkey pox virus• Francisella tularensis• Rift Valley fever virus• Salmonella typhi• Shigella dysenteriae• Tick-borne encephalitis virus (Russian Spring-Summerencephalitis virus)• Vibrio cholerae• Variola virus• Yersinia pestis• Venezuelan equine encephalitis virusToxins• Western equine encephalitis virus• Botulinum toxins• White pox• Clostridium perfringens toxins• Yellow fever virus• Conotoxin• Microcystin (Cyanginosin)• RicinANIMAL PATHOGENS and TOXINSVirusesBacteria• African swine fever virus• Mycoplasma mycoides• Avian influenza virus (some)• Bluetongue virus• Foot and mouth disease virus• Goat pox virus• Porcine herpes virus (Aujeszky’s disease)• Swine fever virus (Hog cholera virus)• Lyssa viruaGENETIC ELEMENTS/GENETICALLY MODIFIED ORGANISMS• Genetic elements that contain nucleic acid sequences associatedwith the pathogenicity of controlled microorganisms.• Genetic elements that contain nucleic acid sequences coding forany controlled “toxins” or “sub-units of toxins.”• Technical Note: Genetic elements include, inter alia,chromosomes, genomes, plasmids, transposons, and vectors,whether genetically modified or unmodified.• Genetically modified organisms that contain nucleic acidsequences associated with the pathogenicity of controlledmicroorganisms.• Genetically modified organisms that contain nucleic acidsequences coding for any controlled “toxins.”PLANT PATHOGENSBacteria• Xanthomonas albilineans• Xanthomonas campestris pv. citri including strains referred to asXanthomonas campestris pv. citri types A,B,C,D,E or otherwiseclassified as Xanthomonas citri, Xanthomonas campestris pv.aurantifolia or Xanthomonas campestris pv. Citrumelo.Fungi• Colletotrichum coffeanum var. virulans (Colletotrichum kahawae)• Cochliobolus miyabeanus (Helminthosporium oryzae)• Microcyclus ulei (Dothidella ulei)• Puccinia graminis (Puccinia graminis f. sp. tritici)• Puccinia striiformis (Puccinia glumarum)• Magnaporthe grisea (pyricularia grisea/pyricularia oryzae)19


A. Exporting from the United StatesDepending on the nature of the shipment, an U.S. export permit may be requiredwhen sending your package. Additionally, an import permit may be required inthe country where the package is being shipped. If your shipment requires anexport permit, it must be completed and approved by the appropriategovernment agency prior to shipment.Note: Packages may be opened and inspected when leaving the United States orat any time by any inspection service provided by other countries. In order toassure that your package is safely delivered to its intended destination, alwaysconsider the following:1. If necessary, obtain an export permit from the appropriate governmentalorganization prior to shipment.2. Package and label the material according to the guidelines listed in thismanual.3. Consider including a courtesy letter with the shipment.B. Importing into the United StatesAll shipments entering the United States are processed by the U.S. Bureau ofCustoms and Border Protection. An import permit may be required to deliver thepackage even if a permit is not required by the originating country. Check withthe appropriate governmental organization prior to shipment of the material.Note: Packages may be opened and inspected upon entry into the United States.In order to assure that your package is safely delivered to its intendeddestination, always consider the following:1. If necessary, obtain an import permit from the appropriate governmentalorganization prior to shipment.2. Package and label the material according to the guidelines listed in thismanual.3. Consider including a courtesy letter with the shipment.The importer is legally responsible for assuring that foreign personnel package,label, and ship the infectious materials according to USPHS and IATAregulations. Shipping labels containing the universal biohazard symbol, theaddress of the importer, the permit number, and the expiration date are alsoissued to the importer with the permit. The importer must send the labels andone or more copies of the permit to the shipper. The permit and labels inform theU.S. Customs and Border Protection and U.S. Division of Quarantine personnelof the package contents.X. Shipping Company RestrictionsShipping companies may have rules more restrictive than those described in thisguide. Examples include:20


• The United States Postal Service (USPS) allows very few hazardous materials tobe mailed, and should not be used as a preferred method of shipment.• United Parcel Service (UPS) will not ship Infectious Substances, Category A.• DHL will accept shipments that comply with IATA or DOT regulations.• Fed Ex Express and Fed Ex Ground will accept shipments that comply withIATA regulations as described in this guide.XI.Shipment SummaryRemember that shipping hazardous materials is a highly regulated industry.Attention to detail, and knowledge of those regulations, will enable your shipments tooccur smoothly, and safely. Use this guide, the summary provided in Table 1, and thefollowing reminders:1. Classify, Mark, and Label correctly.2. Obtain required training, and have a current certificate.3. Refresher training every 2 years.4. Consult with EHS.5. UO’s emergency number for shipping is Chemtrek (1-800-424-9300).6. Maintain shipping records for 2 years.7. Know the exemptions!21


Shipment TypeCategory AInfectiousSubstance(affectinghumans)Category AInfectiousSubstance(affectinganimals)Category BBiologicalSubstancesPatientSpecimensGeneticallyModifiedOrganisms &MicroorganismsBiologicalProductsDry IceLiquidNitrogen in DryShipperOtherHazardousMaterialsProperShippingNameInfectiousSubstance,affectinghumansInfectiousSubstance,affectinganimalsBiologicalSubstance,Category BTable 1: Summary of Shipping InformationAir WaybillDescriptionDangerousGoods perattachedShipper’sDeclarationDangerousGoods perattachedShipper’sDeclarationBiologicalSubstance,Category BExemptHumanSpecimen,or ExemptAnimalSpecimenDG? UN # HazardClassPackingGroup(PG)PackingInstruction(PI)Max. NetQty/PkgforPassengerAircraftYes UN2814 6.2 PI 620 50 mL50 gYes UN2900 6.2 PI 650 50 mL50 gNo UN3373 6.2 PI 650 4 L4 kgNoTriplePackagingUN3245 9 PI 959Max.NetQty/PkgforCargoAircraft4 L4 kgUse in Personal Health Care. Not subject to Dangerous GoodsRegulations.TriplePackagingDry Ice No UN1845 9 III PI 954 200 kg 200 kgUN1845__kg,__pkgsNot NoRestricted,A152See UO Guide to Shipment of Hazardous Materials, and obtain specific training and consultation through theOffice of Environmental Health and Safety.4 L4 kg4 L4 kg22


Appendix A – Category A Infectious Substances*UN # and ProperShipping NameMicroorganismUN 2814Infectious substance affectinghumans- Bacillus anthracis cultures- Brucella abortus cultures- Brucella melitensis cultures- Brucella suis cultures- Burkholderia mallei - Pseudomonas mallei -Glanders cultures- Burkholderia pseudomallei - Pseudomonaspseudomallei cultures- Chlamydia psittaci - avian strains cultures- Clostridium botulinum cultures- Coccidioides immitis cultures- Coxiella burnetii cultures- Crimean-Congo hemorrhagic fever virus- Dengue virus cultures- Eastern equine encephalitis virus cultures- Escherichia coli, verotoxigenic cultures- Ebola virus- Flexal virus- Francisella tularensis cultures- Guanarito virus- Hantaan virus- Hantaviruses causing hantavirus pulmonarysyndrome- Hendra virus- Hepatitis B virus cultures- Herpes B virus cultures- Human immunodeficiency virus cultures- Highly pathogenic avian influenza viruscultures- Japanese Encephalitis virus cultures- Junin virus- Kyasanur Forest disease virus- Lassa virus- Machupo virus- Marburg virus- Monkeypox virus- Mycobacterium tuberculosis cultures- Nipah virus- Omsk hemorrhagic fever virus- Poliovirus cultures- Rabies virus- Rickettsia prowazekii cultures- Rickettsia rickettsia cultures- Rift Valley fever virus- Russian spring-summer encephalitis viruscultures- Sabia virus- Shigella dysenteriae type 1 cultures- Tick-borne encephalitis virus cultures- Variola virus- Venezuelan equine encephalitis virus- West Nile virus cultures- Yellow fever virus cultures- Yersinia pestis culturesUN 2900Infectious substanceaffecting animals- African horse sickness virus- African swine fever virus- Avian paramyxovirus Type 1 - Newcastle disease virus- Bluetongue virus- Classical swine fever virus- Foot and mouth disease virus- Lumpy skin disease virus- Mycoplasma mycoides - Contagious bovine pleuropneumonia- Peste des petits ruminants virus- Rinderpest virus- Sheep pox virus- Goatpox virus- Swine vesicular disease virus- Vesicular stomatitis virus* This list is not exhaustive.23


Appendix B – Manufacturers of Certified Shipping Containers for Infectious Substances,Diagnostic Specimens & Dry IceAir Sea Atlanta1234 Logan CircleAtlanta GA 30318Phone: 404-351-8600http://www.airseaatlanta.comDG Supplies, Inc.5 Boxal DriveCranbury, NJ 08512Phone: 800-347-7879http://www.dgsupplies.comInmark, Inc.220 Fisk Drive S.W.Atlanta, GA 30336-0309Phone: 800-646-6275http://www.inmarkinc.comSAF-T-PAK, Inc.10807 - 182 StreetEdmonton, Alberta, Canada,T5S 1J5Phone: 800-814-7484http://www.saftpak.comAll-Pak, Inc.Corporate One West1195 Washington PikeBridgeville, PA 15017Phone: 800-245-2283http://www.all-pak.comEXAKT Technologies, Inc.7416 N Broadway Ext.,Suite EOklahoma City, OK 73116Phone: 800-923-9123http://www.exaktpak.comJIT Certified, Inc.1740 Fenpark DriveFenton, MO 63026Phone: 800-962-8636http://www.jitcertifed.comSource Packaging of NewEngland, Inc.405 Kilvert St.Warwick, RI 02886Phone: 800-200-0366http://www.sourcepak.comCARGOpak Corporation3215-A Wellington CourtRaleigh, NC 27615Phone: 800-266-0652http://www.cargopak.comHAZMATPAC, Inc5301 Polk St., Bldg 18Houston, TX 77023Phone: 800-347-7879http://www.hazmatpac.comPolyfoam PackersCorporation2320 S. Foster AvenueWheeling, IL 60090Phone: 888-765-9362http://www.polyfoam.comTherapak Corporation1440 Arrow Highway, UnitAIrwindale, California 91706Phone: 888-505-7377http://www.therapak.com24


Appendix C – Example Shipper’s Declaration for Dangerous Goods25


Appendix D – Intent to Ship Hazardous MaterialsAfter reading the UO Shipment of Biological Materials Manual, fill out this form and submit it to EHS in advance of ashipment. EHS will review this completed form and advise on necessary steps to successfully ship the package. It may benecessary for you to obtain certified training if shipping personnel within your department are not currently certified.1. What regulated material(s) might you ship via mail or courier service? List all hazardous materials that you intend toship. Also, list the mailing service you intend to use.2. What packaging will you use to ship your material(s)? Include company name and product number for chosenpackaging for each material you intend to ship.3. Check those that should appear on your package: Class 6.2 label Class 9 label Cargo Aircraft label Dry ice, UN 1845, net weight _____ kg Infectious substance, affecting humans (technical name), UN 2814, net quantity _____ Infectious substance, affecting animals (technical name), UN 2900, net quantity _____ Technical name of infectious substance _____ Biological Substance, Category B, UN 3373, net quantity ____ Name, Address and Phone Number of Shipper ____ Name and Address of Consignee ____ Name and Phone Number of Person Responsible for Shipment ____ Overpack label Genetically modified micro-organisms, UN 3245, net quantity _____ Exempt Human Specimen Exempt Animal Specimen Liquid Nitrogen in a Dry Shipper4. Fill out a Shipper’s Declaration for Dangerous Goods (if your shipments require one) and submit for review.I understand the hazards associated with the materials noted above. Also, I understand the shipping requirements forthose materials, as outlined in this manual.Print name:Signature:Date:Please return, in campus mail, to EHS –72 Onyx Bridge.26


Appendix E – APHIS Plant Pathogens, HHS Select Infectious Agents & USDA High Consequence Livestock Pathogens/ToxinsViruses1. African horse sickness virus 32. African swine fever virus 33. Akabane virus 34. Avian influenza virus (highly pathogenic) 35. Blue tongue virus (exotic) 36. Camel pox virus 37. Cercopithecine herpesvirus 1 (Herpes B virus) 28. Classical swine fever virus 39. Crimean-Congo haemorrhagic fever virus 210. Eastern equine encephalitis virus 411. Ebola viruses 212. Foot and mouth disease virus 313. Goat pox virus 314. Hendra virus 415. Japanese encephalitis virus 316. Lassa fever virus 217. Lumpy skin disease virus 318. Malignant catarrhal fever virus 319. Marburg virus 220. Menangle virus 321. Monkeypox virus 222. Newcastle disease virus (VVND) 323. Nipah virus 424. Peste des petits ruminants virus 325. Rift Valley fever virus 4 Υ26. Rinderpest virus 3 δ27. Sheep pox virus 328. South American haemorrhagic fever viruses [(Junin,Machupo, Sabia, Flexal, Guanarito)] 229. Swine vesicular disease virus 330. Tick-borne encephalitis complex (flavi) viruses [CentralEuropean Tick-borne encephalitis, Far Eastern Tickborneencephalitis (Russian Spring and Summerencephalitis, Kyasanur Forest disease, OmskHemorrhagic Fever)] 231. Variola major virus (Smallpox virus) and Variola minor(Alastrim) 232. Venezuelan equine encephalitis virus 433. Vesicular stomatitis virus (exotic) 3Prion1. Bovine spongiform encephalopathy agent 3Toxins1. Abrin 22. Botulinum neurotoxins 43. Clostridium perfringens epsilon toxin 44. Conotoxins 25. Diacetoxyscirpenol 26. Ricin 27. Saxitoxin 28. Shigatoxin and Shiga-like ribosome inactivating proteins 49. Staphylococcal enterotoxins 410. Tetrodotoxin 211. T– 2 toxin 4Bacteria1. Bacillus anthracis 42. Botulinum neurotoxin producing species of Clostridium 43. Brucella abortus 44. Brucella melitensis 45. Brucella suis 46. Burkholderia mallei7. Burkholderia pseudomallei 48. Candidatus Liberobacter africanus 19. Candidatus Liberobacter africanus 110. Coxiella burnetii 411. Cowdria ruminantium (Heartwater) 312. Francisella tularensis 413. Liberobacter africanus, Liberobacter asiaticus 114. Mycoplasma capricolu/M. F38/M. mycoides capri (contagiouscaprine pleuropneumonia agent) 315. Mycoplasma mycoides mycoides (contagious bovinepleuropneumonia agent) 316. Ralstonia solanacearum race 3 biovar 2 117. Rickettsia prowazekii 218. Rickettsia rickettsii 219. Xanthomonas oryzae pv. oryzicola 120. Xylella fastidiosa (citrus variegated chlorosis strain) 121. Yersinia pestis 2Fungi1. Coccidioides immitis 42. Coccidioides posadasii 23. Peronosclerospora philippinensis 14. Sclerophthora rayssiae var zeae 15. Synchytrium endobioticum 1ExemptionsThe following agents or toxins are exempt if the aggregate amountunder the control of a principal investigator does not, at any time,exceed:• 0.5 mg of botulinum neurotoxins• 5 mg of Staphylococcal enterotoxins• 100 mg of abrin, Clostridium perfringens epsilon toxin,conotoxin, ricin, saxitoxin, shigatoxin, shiga-like ribosomeinactivating protein, and tetrodotoxin• 1,000 mg of diacetoxyscirpenol and T-2 toxinThe following agents or toxins are also exempt:• Any agent or toxin that is in its naturally occurringenvironment provided it has not been intentionally introduced,cultivated, collected, or otherwise extracted from its naturalsource.• Non-viable select agent organisms or nonfunctional toxins.• The vaccine strains of Junin virus (Candid #1), Rift Valley fevervirus (MP-12), Venezuelan Equine encephalitis virus vaccinestrain TC-83.The medical use of toxins for patient treatment is exempt.Genetic Elements, Recombinant Nucleic Acids, and RecombinantOrganisms1. Select agent viral nucleic acids (synthetic or naturally derived,contiguous or fragmented, in host chromosomes or inexpression vectors) that can encode infectious and/orreplication competent forms of any of the select agent viruses.2. Nucleic acids (synthetic or naturally derived) that encode forthe functional form(s) of any of the listed toxins if the nucleicacids: a) are in a vector or host chromosome; b) can beexpressed in vivo or in vitro; or c) are in a vector or hostchromosome and can be expressed in vivo or in vitro.3. Listed viruses, bacteria, fungi, and toxins that have beengenetically modified.Other Restrictions1. Experiments utilizing recombinant DNA that involve thedeliberate transfer of a drug resistance trait to the listed agentsthat are not known to acquire the trait naturally, if suchacquisition could compromise the use of the drug to controldisease agents in humans, veterinary medicine, or agriculture.2. Experiments involving the deliberate formation of recombinantDNA containing genes for the biosynthesis of listed toxins lethalfor vertebrates at an LD50 < 100 ng/kg body weight.27


Appendix F – Additional HHS and USDA Select Agent/High Consequence PathogenExemptionsAttenuated strains of HHS select agents and toxins excluded:• Coccidioides posadasii ∆ch s5 strain .• Conotoxins specifically excluded are: the class of sodium channel antagonist μ-conotoxins,including GIIIA; the class of calcium channel antagonist ω-conotoxins, including GVIA,GVII, MVIIA, MVIIC, and their analogs or synthetic derivatives; the class of NMDAantagonistconantokins, including con-G, con-R, con-T and their analogs or syntheticderivatives; and the putative neurotensin agonist, contulakin-G and its syntheticderivatives.• Yersinia pestis strains which are Pgm - due to a deletion of a 102-kb region of thechromosome termed the pgm locus (i.e., ∆pgm). Examples are Y. pestis strain E.V. orvarious substrains such as EV 76.• Yersinia pestis strains (e.g., Tjiwidej S and CDC A1122) devoid of the 75 kb low-calciumresponse (Lcr) virulence plasmid.Attenuated strains of Overlap select agents and toxins excluded:• Bacillus anthracis strains devoid of both plasmids pX01 and pX02.• Bacillus anthracis strains devoid of the plasmid pX02 (e.g., Bacillus anthracis Sterne,pX01 + pX02 - ).• Brucella abortus Strain 19.• Brucella abortus strain RB51 (vaccine strain).• Coxiella burnetii Phase II, Nine Mile Strain, plaque purified clone 4.• Francisella tularensis subspecies novicida (also referred to as Francisella novicida) strain,Utah 112 (ATCC 15482).• Francisella tularensis subspecies holartica LVS (live vaccine strain; includes NDBR 101lots, TSI-GSD lots, and ATCC 29684).• Francisella tularensis ATCC 6223 (also known as strain B38).• Venezuelan Equine Encephalitis (VEE) virus vaccine candidate strain V3526.Attenuated strains of USDA select biological agents and toxins excluded:• Japanese encephalitis virus SA14-14-2 strain.29

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