1. 1 University of Colorado at Colorado Springs Shipping Biological Materials Certification Course Department of Environmental Health and Safety www.uccs.edu/~pusafety/environmental/index.shtml

2. 2 Introduction The purpose of this training module is to familiarize the Principal Investigator and lab personnel with the regulations, different shipping categories; and proper labeling and packaging of biological materials. The information in the slides will provide just an overview. The links in the slides and the support resources and packing instructions at The purpose of this training module is to familiarize the Principal Investigator and lab personnel with the regulations, different shipping categories; and proper labeling and packaging of biological materials. The information in the slides will provide just an overview. The links in the slides and the support resources and packing instructions at www.uccs.edu/~pusafety/environmental/index.shtml www.uccs.edu/~pusafety/environmental/index.shtml will provide the necessary shipping details.

3. 3 Introduction Packing & Shipping Infectious Substances ● Roles, Responsibilities, & Regulations ● Training Requirements ● Definitions ● Classifications & Identification of Infectious Substances ● Packing Instructions, Materials, & Labels ● Shipper’s Declaration for Dangerous Goods International Aspects Certification Quiz Outline of Course Please contact EH&S at 255-3201 if you have questions or need assistance in completing this course.

4. 4 Requirements and regulations change frequently and are subject to interpretation. Requirements and regulations change frequently and are subject to interpretation. This training is required every two years unless requirements or regulations significantly change within this time frame. This training is required every two years unless requirements or regulations significantly change within this time frame. EH&S will notify you when training is due. Please make sure to keep your training records available. EH&S will notify you when training is due. Please make sure to keep your training records available.

5. 5 safety reasons safety reasons legal reasons legal reasons financial reasons financial reasons Authorities may examine laboratories laboratories documentation documentation normal packages normal packages all “leakers” all “leakers” Why Should We Follow Regulations?

6. 6 Canada TDGR US C FR 49 Other Regs Other RegsCountries Sources of Regulations IATA DGR Intl Civil Av Org (ICAO) Technical Instructions United Nations (UN) COETDG (~30 countries) Model Regulations

7. 7 The US Department of Transportation’s (DOT) Hazardous Materials Regulations (HMR) govern the transport of hazardous materials in domestic shipments. The HMR are consistent with regulations for international shipment.Hazardous Materials Regulations The Federal Aviation Administration (FAA) Office of Hazardous MaterialsThe Federal Aviation Administration (FAA) Office of Hazardous Materials aims to prevent hazardous materials incidents aboard aircraft. The FAA may audit anyone who ships biological materials by air. The United States Postal Service (USPS)The United States Postal Service (USPS) regulates the shipment of hazardous materials by mail. Most hazardous materials are prohibited in USPS shipments. Use of USPS for HazMat shipments should be avoided. The US Department of Labor Occupational Safety and Health Administration (OSHA)The US Department of Labor Occupational Safety and Health Administration (OSHA) regulates safety for workers who handle, package and transport HazMat. The Department of Commerce (DOC)The Department of Commerce (DOC) maintains a list of controlled items that cannot be exported, or which require a permit for export, from the US. Additional information on Export Controls is available from the Office of Regulatory Compliance, Export Controls. The Centers for Disease Control and Prevention (CDC)The Centers for Disease Control and Prevention (CDC) provide requirements for shipments of infectious substances, as well as import permits for disease-causing materials. The US Department of Agriculture (USDA)The US Department of Agriculture (USDA) regulates the importation and interstate transport of animal and plant materials. Transportation Regulations

8. 8 Penalties for Violations HazMat regulations are not just guidelines; they are the law. Violations of HazMat laws may result in serious civil and criminal penalties, ranging from $250 to $55,000 per incident, per day. In some cases, a criminal penalty of up to $500,000 and/or imprisonment of up to 5 years will apply. Some (though far from all) of the fines you may incur for failure to abide by regulations: o o Undeclared Shipment… $15,000 minimum o o Failure to provide a shipping paper for a shipment of hazardous materials… $3,000 minimum o o Failure to include a proper shipping name in the shipping description or using an incorrect proper shipping name… $800 minimum o o Failure to include a hazard class or division number in the shipping description… $1,000 minimum o o Failure to include a required technical name in parenthesis for a listed generic or “n.o.s.” (“not otherwise specified”) material… $1,000minimum o o Offering a hazardous material for transport in an unauthorized, non-UN standard or nonspecification packaging… $5,000 minimum

9. 9 DOT An infectious substance is regulated as a hazardous material under the U.S. Department of Transportation’s (DOT’s) Hazardous Materials Regulations (HMR; 49 CFR Parts 171-180). The HMR apply to any material DOT determines is capable of posing an unreasonable risk to health, safety, and property when transported in commerce. An infectious substance must conform to all applicable HMR requirements when offered for transportation or transported by air, highway, rail, or water. Regulations are now consistent with international standards - IATA, UN, WHO

10. 10 IATA Dangerous Goods Regulations current edition (annual) an airline trade publication an airline trade publication developed directly from ICAO developed directly from ICAO a guide recognized by the world’s airlines a guide recognized by the world’s airlines govern shipping regulated materials by air, nationally and internationally govern shipping regulated materials by air, nationally and internationally no legal authority no legal authority Sources of Information

11. 11 Guidance on Regulations for the Transport of Infectious Substances (2009-2010) Applicable from 1 January 2009 WHO/HSE/EPR/2008.10 http://whqlibdoc.who.int/hq/2008/WHO_HSE_EPR_2008.10.pdf Sources of Information

12. 12 Federal Register Title 49 – transportation Title 49 – transportation Continually updated Continually updated legal authority legal authority available on-line available on-line Sources of Information

13. 13 These regulations work, and workers are protected ! WHO, 2005 In 2003, 4,920,000 packages of infect subs were shipped worldwide. Only 106 (0.002%) of the packages were reported damaged. All of the packages contained absorbent material which contained the leaking material. NONE of the secondary or outer containers was damaged WHO, 2007 to date, NO reported cases of illness due to the release of infectious substance during transport

14. 14 These regulations apply to anyone who… prepares paperwork for biological materials for shipment (Shipper’s Declaration) prepares paperwork for biological materials for shipment (Shipper’s Declaration) packs biological materials for shipment, packs biological materials for shipment, transports biological materials, transports biological materials, handles, loads or unloads shipments of biological materials handles, loads or unloads shipments of biological materials

15. 15 USA: Regulations DO NOT apply to Category B substances and patient specimens transported by private or contract carrier in motor vehicles used only for transporting same. Transport by Courier City Lab Service

16. 16 OSHA regulations apply OSHA regulations apply biohazard labels biohazard labels double containers double containers stabilized containers stabilized containers no passengers no passengers taxis OK taxis OK Transport by Courier

17. 17 More Stringent Regulations: Passengers and crew members are prohibited from transporting infectious substances as or in carry-on baggage, checked baggage or on their person. State Variations Each country or “state” may adopt more stringent regulations Operator Variations Every airline is allowed to adopt more rigid regulations in place Transport by Airlines

18. 18 Who Is a Shipper? A shipper can be anyone who offers dangerous goods for transport offers dangerous goods for transport to a commercial carrier (DHL, FedEX, to a commercial carrier (DHL, FedEX, Delta, British Air, etc.) or Delta, British Air, etc.) or signs a Shipper’s Declaration signs a Shipper’s Declaration for Dangerous Goods. for Dangerous Goods. could be you could be courier

19. 19 Shippers of Category A infectious substances must: be trained be trained - general: functions, regulations -function-specific: packing, handling - safety: hazards presented by infectious - safety: hazards presented by infectious substances, safe handling, and emergency substances, safe handling, and emergency response procedures response procedures - security: if shipping Category A, or select agents, - security: if shipping Category A, or select agents, or otherwise appropriate or otherwise appropriate be tested (documentation of passing) be tested (documentation of passing) receive a certificate with details of training receive a certificate with details of training be certified by the employer (EH&S) be certified by the employer (EH&S) Training Requirements

20. 20 Retraining is required. IATA DOT (USA) IATA DOT (USA) every 2* years every 3* years every 2* years every 3* years *Required sooner if requirements or regulations change within this time frame. Training Requirements

21. 21 When you pack and ship you must … DECIDE if Substance Is a DG and Subject to Regulations CLASSIFY the Substance IDENTIFY the Substance SELECT Packing Instructions and Packaging PACK the Substance Correctly MARK and LABEL the Package DOCUMENT the Shipment if Category A

22. 22 dangerous goods -- articles or substances which are capable of posing a risk to health, safety, property or the environment and which are shown in the list of dangerous goods in the IATA Dangerous Goods Regulations Definitions

23. 23 Hazardous materials-- a substance or material that the Secretary of Transportation has determined is capable of posing an unreasonable risk to heal, safety and property when transported in commerce, and has designated as hazardous under section 5103 of the Federal hazardous materials transportation law (49 U.S.C. 5103) Definitions

24. 24 infectious substance -- substances known or reasonably expected to contain pathogens pathogens -- microorganisms (including bacteria, viruses, fungi, parasites, rickettsiae, and prions) which can cause disease in humans or animals Definitions

25. 25 culture -- the result of a process by which pathogens are amplified or propagated patient specimen -- human or animal material for diagnosis, research, treatment, or prevention purposes (eg, serum, excreta, secreta, tissue, body fluids, organs, parts, and swabs of same). Definitions

26. 26 Toxic substance-- a substance that is liable to cause death or injury or to harm human health if swallowed, inhaled or contacted by the skin. Note: Toxins from plant, animal, or bacterioal sources which do not contain any infectious substances OR toxins that are contained in substances which are not infectious substances must be considered for classification in Division 6.1 and assignment to UN 3172. Contact EHS for assitance if shipping a toxic substance Definitions

27. 27 The First Question: Is the Substance a Hazardous Material/Dangerous Good? Classify the substance Regulations DO NOT apply NO YES Regulationsapply

28. 28 Explosives Class 1 Explosives Gasses Class 2 Gasses Flammable Liquids Class 3 Flammable Liquids Flammable Solids Class 4 Flammable Solids Oxidizing Substances Class 5 Oxidizing Substances Toxic / Infectious Substances Class 6 Toxic / Infectious Substances 6.1 Toxic Substances 6.2 Infectious substances Radioactive Substances Class 7 Radioactive Substances Corrosive Substances Class 8 Corrosive Substances Miscellaneous Class 9 Miscellaneous Our Topic DOT & IATA Classes of Dangerous Goods

29. 29 Classification of Infectious Substances Category A SubstancesCategory B Substances Exempt Human / Animal Specimens Exempt Substances Biological Products Patient Specimens Infectious Substances Genetically Modified Micro-Organisms and Organisms Medical or Clinical Wastes Infected Animals Patient Specimens

30. 30 an infectious substance in a form that, when exposure to it occurs, is capable of causing permanent disability, life-threatening or fatal disease in healthy humans/animals an infectious substance in a form that, when exposure to it occurs, is capable of causing permanent disability, life-threatening or fatal disease in healthy humans/animals assigned to UN 2814 (affecting humans)or UN 2900 (affecting animals only) assigned to UN 2814 (affecting humans)or UN 2900 (affecting animals only) follow Packing Instructions 620 follow Packing Instructions 620 DOT and IATA include list of Category A substances DOT and IATA include list of Category A substances Classification of Infectious Substances Category A Substances

31. 31 Examples of Category A Substances viruses -- ebola, junin, lassa, machupo, viruses -- ebola, junin, lassa, machupo, marburg, monkeypox,smallpox marburg, monkeypox,smallpox viruses -- West Nile, polio, avian viruses -- West Nile, polio, avian influenza, HIV, hepatitis B, rabies, influenza, HIV, hepatitis B, rabies, Rift Valley fever Rift Valley fever bacteria -- M. tuberculosis Rickettsia, bacteria -- M. tuberculosis Rickettsia, S dysenteriae 1, VT E. coli, B anthracis, S dysenteriae 1, VT E. coli, B anthracis, B abortus, B pseudomalei, F tularensis, B abortus, B pseudomalei, F tularensis, Y. pestis, Y. pestis, IN ANY FORM CULTURESONLY Classification of Infectious Substances

32. 32 an infectious substance which does not meet the criteria for inclusion in Category A an infectious substance which does not meet the criteria for inclusion in Category A assigned to UN 3373 assigned to UN 3373 follow Packing Instructions 650 follow Packing Instructions 650 Examples - most clinical microbiology specimens & organs most clinical microbiology specimens & organs usually pure cultures usually pure cultures specimens for HIV or HCV quantitation specimens for HIV or HCV quantitation specimen to be cultured for organisms specimen to be cultured for organisms could be expected to cause infection could be expected to cause infection serum tested for Antibodies to infectious agents serum tested for Antibodies to infectious agents Classification of Infectious Substances Category B Substances

33. 33 Classification of Infectious Substances Specimens for which there is minimal likelihood that pathogens are present… professional judgment is required. Examples – collected directly collected from humans or animals for purposes such as research, diagnosis, investigational activities, disease treatment and prevention: biopsies for cancer testing biopsies for cancer testing excreta, secreta, blood and its components, tissue and tissue fluid swabs, body parts excreta, secreta, blood and its components, tissue and tissue fluid swabs, body parts serum for non-ID Ab / serology tests serum for non-ID Ab / serology tests blood and urine for chem, glu, hor, PSA, preg, blood and urine for chem, glu, hor, PSA, preg, TDM, organ function tests, drugs, insurance purposes TDM, organ function tests, drugs, insurance purposes Exempt Human / Animal Specimens

34. 34 Classification of Infectious Substances likely to contain or being tested for pathogen(s) or has reasonable potential to cause disease in humans or animals likely to contain or being tested for pathogen(s) or has reasonable potential to cause disease in humans or animals assigned to UN 3373 assigned to UN 3373 Patient Specimens Category A Substances Category B Substances Exempt Human / Animal Specimens Must be classified as one of these: an infectious substance which is transported in a form that, when exposure to it occurs, is capable of causing permanent disability, life- threatening or fatal disease in otherwise healthy humans or animals an infectious substance which is transported in a form that, when exposure to it occurs, is capable of causing permanent disability, life- threatening or fatal disease in otherwise healthy humans or animals assigned to UN 2814 or UN 2900 assigned to UN 2814 or UN 2900 does not contain an infectious substance or that is likely to cause disease in humans or animals does not contain an infectious substance or that is likely to cause disease in humans or animals

35. 35 Because of the low hazard they present, the following substances of biological origin are exempted from hazardous materials regulations (DOT) and dangerous goods requirements (IATA). do not contain infectious substances do not contain infectious substances will not cause human / animal disease will not cause human / animal disease contain inactivated / neutralized pathogens, no longer pose a health risk contain inactivated / neutralized pathogens, no longer pose a health risk environmental samples (water, soil, food, etc.) environmental samples (water, soil, food, etc.) blood / components for transfusion or transplant blood / components for transfusion or transplant dried blood spots & fecal occult blood specimens dried blood spots & fecal occult blood specimens decontaminated medical waste decontaminated medical waste Classification of Infectious Substances Exempt Substances

36. 36 If known or reasonably expected to contain a pathogen that meets the definition of a Category A or B infectious substance must be assigned the identification number UN2814, UN2900 or UN3373, as appropriate derived from living organisms which are manufactured and distributed in accordance with the appropriate national authorities, which may have special licensing requirements derived from living organisms which are manufactured and distributed in accordance with the appropriate national authorities, which may have special licensing requirements used either for prevention, treatment, or diagnosis of disease in humans or animals used either for prevention, treatment, or diagnosis of disease in humans or animals for development, experimental or investigational purposes related thereto for development, experimental or investigational purposes related thereto include, but not limited to finished or unfinished products such as vaccines include, but not limited to finished or unfinished products such as vaccines Classification of Infectious Substances Biological Products

37. 37 genetic material has been purposely altered through genetic engineering in a way that does not occur naturally genetic material has been purposely altered through genetic engineering in a way that does not occur naturally do not meet the definition of an “infectious substance” but are capable of altering animals, plants or microbiological substances in a way not normally the result of natural reproduction do not meet the definition of an “infectious substance” but are capable of altering animals, plants or microbiological substances in a way not normally the result of natural reproduction assigned to UN 3245 assigned to UN 3245 follow Packing Instructions 959 follow Packing Instructions 959 Classification of Infectious Substances Genetically Modified Micro-Organisms and Organisms

38. 38 wastes derived from the medical treatment of animals or humans or from bio-research medical or clinical wastes containing Category A infectious substances - assigned to UN 2814 or UN 2900 as appropriate medical or clinical wastes containing Category B infectious substances, or which are reasonably believed to have a low probability of containing infectious substances – assigned to UN 3291 and follow Packing Instructions 622 Classification of Infectious Substances Medical or Clinical Wastes

39. 39 a live animal that has been intentionally infected and is known or suspected to contain an infectious substance transport by air is prohibited unless infectious substance contained can be consigned by any other means may only be transported under terms and conditions approved by the appropriate national authority animal carcasses affected by pathogens of Category A or which would be assigned to Category A in cultures only, must be assigned to UN 2814 or UN 2900 as appropriate other animal carcasses affected by pathogens included in Category B must be transported in accordance with provisions determined by the competent authority Classification of Infectious Substances Infected Animals

40. 40 Classification of Infectious Substances Miscellaneous Dangerous Goods DRY ICE

41. 41 known or suspected Cat B Category B Infectious Substance (UN3373) Classification of Infectious Substance Being Shipped Patient Specimen (professional judgement should be used; if unable to make professional judgement, consider Category B) l l for tests not related to an infectious disease l l or no reason to suspect the specimen is infectious l l or unlikely to cause disease in humans or animals l l or does not contain, has minimal liklihood of containing, or is not being tested for pathogens Exempt Substance Exempt Human or Animal Specimen Category A Infectious Substance ) (UN2814 or UN2900) Patient Specimen or Culture (professional judgement should be used) l l likely to contain or being tested for pathogen(s) l l or has reasonable potential to cause disease in humans or animals Biological Substances l l does not contain infectious substance l l contains inactivated or neutralized pathogens l l contains nonpathogenic organisms l l environmental samples l l dried blood spots l l fecal occult blood specimens l l decontaminated medical waste l l to be used for transplant or transfusion l l known or suspected Cat A l l or is being tested for Cat A l l or has characteristics of Cat A l l or cannot rule out Cat A l l or uncertain if Cat A or Cat B l l or is a serious health risk to carrier

42. 42 620 ---- Infectious Substance, Category A 650 ---- Biological Substance, Category B 954 ---- Dry Ice 959 ---- GMMOs and GMOs Other -- Exempt Human & Animal Specimens Only 4 Packing Instructions These Packing Instructions have been included as separate documents at These Packing Instructions have been included as separate documents at www.uccs.edu/~pusafety/environmental/index.shtml

43. 43 Packing Instruction 650 <30 mL of 10% formalin may be packed in each primary container containing infectious substances. 10% Formalin

44. 44 Comparison of Packing Instructions and Directions

45. 45 Appropriate Packaging Materials Examples of Commercial Sources For Packing Materials http://www.dgsupplies.com/ http://www.air-sea.co.uk/ http://www.airseaatl anta.com/ http://www.airseaatl anta.com/ http://www.thermosafe.com/ http://www.saftpak.com/ http://www.exaktpak.com/ http://www.fishersci.com/wps/portal/HOME

46. 46 Packaging Systems   Packaging systems for shipping are tested as a complete unit and no substitutions are allowed.   Packaging systems consist of:   Liquid-tight primary and secondary containers   Absorbent materials between primary and secondary containers   Cushioning and separating material   A list of contents and total weight of fluids between secondary and outer packagings   A UN certification marking on outer packaging   All required labels and markings   Shipper and recipient addresses

47. 47 Packaging Containers 1o1o 2o2o outer The smallest external dimension of the outer packaging must not be less than 100 mm x 100 mm (3.9 inches x 3.9 inches)

48. 48 Packaging Options 1o1o 2o2o OUTER

49. 49 1o1o 2o2o OUTER 1o1o 2o2o 1o1o 2o2o Packaging Options

50. 50 1o1o1o1o 2o2o2o2o OUTER INSULATION Packaging Options Shipping with Ice and Dry Ice Place ice and dry ice OUTSIDE the secondary container.

51. 51 Class 6 Infectious Substance Label USA: Must Be CDC 800 Number!

52. 52 Outer Container Labels UN 4G/CLASS 6.2/02 CAN/8-2 AIRCARGO Outer packaging used to ship a Cat A substance must have a UN label like this. The label must be printed by the manufacturer.

53. 53 UN 4G/CLASS 6.2/02 CAN/8-2 AIRCARGO UN Certification Type of Package PackagingMaterial Dangerous Goods Class Year of Manufacture Country Authorizing Use Manufacturer

54. 54 Labels and Markings on Outer Container Exempt Human Specimen or Exempt Animal Specimen name & number of responsible person Sender Receiver Exempt Human Specimen Follow Exempt Human Specimen Directions

55. 55 Labels and Markings on Outer Container DRY ICE, UN 1845 3 KG NET WT Biological Substance, Category B UN3373 name & number of person responsible for the 6.2 shipment Sender Receiver Follow Packing Instructions 650 Biological Specimen, Category B

56. 56 DRY ICE, UN 1845 3 KG NET WT name & number of person responsible for the 6.2 shipment Sender Receiver Labels and Markings on Outer Container 4G/CLASS 6.2/2004 CAN/8-2 AIRPACK UN Infectious Substance, Category A Infectious Substance, Affecting Humans or Infectious Substance Affecting Animals UN Number, & Quantity Follow Packing Instructions 620

57. 57 Shipping with Dry Ice NEVER TIGHTLY SEAL A CONTAINER WHICH CONTAINS DRY ICE! NEVER! Dry ice is a CLASS 9 dangerous good and must be listed on the Shipper’s Declaration Dry ice is a CLASS 9 dangerous good and must be listed on the Shipper’s Declaration ALWAYS vent outer package! ALWAYS vent outer package! Package must be marked and labeled. Package must be marked and labeled. DRY ICE UN 1845 3 KG NET WT and

58. 58 Liquids LiquidsSolids 1o1o1o1oOuter 1o1o1o1oOuter Cat A 50 mL 50 g Cat B 1 L 4 L n/s 4 kg n/s, not specified Maximum Quantity Limits for Either Passenger or Cargo Aircraft

59. 59 Special Provisions (“Exceptions”) A47 Genetically Modified Micro-organism GMMO) and Genetically Modified Organism (GMO) which are packed in accordance with Packing Instruction 959 are not subject to any other requirements. If GMMO or GMO meet the definition of toxic substance or infectious substance and the criteria for inclusion in Class 6.1 or 6.2 (Category A or B), then DOT and IATA Regulations apply.

60. 60 Special Provisions (“Exceptions”) A48 Dry Ice: Packaging tests are not necessary. A140 The technical name must follow in ( ) in association with the Proper Shipping Name on Shipper’s Declaration (NOT on outer package). If it is a suspected Category A substance and if technical name not known, use: “Suspected Category A Infectious Substance” in ( ). following the Proper Shipping Name on Shipper’s Declaration (NOT on outer package).

61. 61 DOT Exception Specimen packages marked as “Exempt human specimen” or “Exempt animal specimen” according to the ICAO Technical Instructions are not regulated under the HMR. In the United States, the mark “Exempt Human/Animal Specimen” is an indication that there is no infectious substance in the package. Packages bearing these marks may be accepted by an air carrier that has made a business decision not to accept hazardous materials.

62. 62 DOT Classification Example

63. 63 Shipping papers Shipping papers are the forms necessary for transport, billing and accountability for shipping HazMat. Shipping papers will vary depending on the carrier you use, and whether it is a domestic or international shipment. Contact Office of Sponsored Programs and Research Integrity if shipping internationally. You may be required to obtain export permits, import permits (for certain shipments between US states) and to prepare customs declarations or commercial invoices. Each of these documents must be prepared correctly, sometimes weeks in advance (for import permits) to get packages where they need to go.

64. 64 Shipping papers Shipping papers may include: Notification to EHS – Shipping Biological Materials Shipper’s Declaration of Dangerous Goods Air Waybills Shipping orders Bills of lading Manifests Security Plan

65. 65 ALL shipments of Category A substances MUST be documented on this form. Shipper’s Declaration for Dangerous Goods

66. 66 Shipper’s Declaration of Dangerous Goods The Shipper’s Declaration of Dangerous Goods must always be typed, not hand written. The form may be printed in black and red on white paper or it may be printed in red only on white paper. The diagonal hatch marks printed vertically on the left and right sides of the page must be printed in red. There must be enough copies of the form to maintain records and provide the carrier with the required number of copies for shipment. You must always provide a minimum of two signed copies to the carrier. Some carriers (e.g. FedEx) now allow or require forms to be filled online or with carrier-specific software. Check with your shipping vendor to see what HazMat shipping documents they require.

67. 67 Shipper’s Declaration of Dangerous Goods Click here to obtain a fillable Shipper's Declaration of Dangerous Goodsform.Shipper's Declaration of Dangerous Goods Click here to obtain a Guidance Document for Completing the Shipper's Declaration for Category A Materials.Guidance Document for Completing the Shipper's Declaration for Category A Materials Click here for Examples of Shipper's Declarations.Examples of Shipper's Declarations

68. 68 Shipper’s Declaration, continued Shipper: The person sending the materials. The shipper must enter his or her full name, shipping address and telephone number. Consignee: The recipient of the package. Enter the full name and address of the recipient. For infectious substances, the shipper must also enter the text “Person responsible for the Shipment” and enter the shipper’s name and telephone number again. Export controls may apply. If shipping overseas, consult with Office of Sponsored Programs and Research Integrity before shipping. If shipping plant or animal materials, or infectious agents which affect plants or animals interstate, you may need a USDA permit. Consult the USDA first.

69. 69 LiquidsSolids Primary Container Outer Container Primary Container Outer Container Division 6.2, Category A 50 mL 50g Division 6.2, Category B 1L4 LCannot exceed the outer container weight limit 4kg Transport Details An entry is required here if your shipment is limited to cargo aircraft. The table below gives the quantity and volume limits for infectious substances shipped by aircraft. Quantity and Volume Limits for Division 6.2 substances on cargo aircraft.

70. 70 Airport of Departure This information will be entered by the carrier. Leave it blank. Shipment Type Cross out “radioactive” to indicate that a non-radioactive material is being shipped.

71. 71 Proper Shipping Names For all materials, a generic proper shipping name (see chart below) must be assigned by the individual preparing the shipment. You must use Roman font (not italics). The scientific or technical name may be included, in parentheses and italicized. UN Codes (ID Numbers) UN Codes are identification numbers describing materials for domestic or international shipments.

72. 72 Identification of the Substance (Proper Shipping Name) 3,000 dangerous goods >3,000 dangerous goods and proper shipping names and proper shipping names nly 6 names apply to Only 6 names apply to Classified Substances. Classified Substances. each name… 14 items of info needed 14 items of info needed to identify, pack, ship, to identify, pack, ship, and document and document

73. 73 6 Proper Shipping Names For Infectious Substances and Dry Ice Category B Substances Dry Ice Category A Substances

74. 74 Dangerous Goods IdentificationQuanti ty and type of packin g Packi ng Inst. Authorization Proper Shipping Name Clas s or Divi sion UN or ID No. Pac king Gro up Subsid iary Risk Infectious substances, affecting humans (Example: Yer sinia pestis) 6.2UN2 814 1.0 ml in fiberb oard box 620 Packing Group Packing Group does not apply when shipping Division 6.2 biological materials, Class 9 Dry Ice, or Class 9 GMO. Subsidiary Risk Not applicable for Division 6.2 Quantity and Type of packing The shipper must list the number of packages of the same type and content, their type of packaging (e.g. “fiberboard box” or “box, fiberboard”, or “4G”) and the net weight or volume of each hazardous item per package associated with a Proper Shipping Name or UN Number.

75. 75 Packing Instructions Packing Instructions for each type of substance are numerically coded. The code represents detailed information for shipping each specific substance. IATA Guidance Document for infectious Substances Authorization For use with Limited Quantity (LQ) provisions.

76. 76 Additional Handling Information List any special handling procedures that must be followed to protect the integrity or safe handling of the substance. Include the UN code for that substance.

77. 77 Shipper Declaration Must Include: Name and telephone # of a person who can provide emergency response and accident mitigation information OR OR an immediately available person or company with such knowledge Emergency Contact: William Truitt (598) 346-1223 EMERGENCY RESPONSE NUMBER (USA) A USA Requirement

78. 78 Certification The last entry on the shipping papers is the shipper’s certification that the hazardous materials are prepared for shipment according to the HMR. Enter your name and title, place and date of signing, and provide a signature.

79. 79 The following substances do not require a Shipper’s Declaration:   Human Specimens-Exempt   Division 6.2, Biological Substance, Category B, UN 3373   Division 9, Genetically modified organisms, UN 3245   Division 9, Carbon dioxide, solid (Dry ice), UN 1845 when used as a refrigerant for UN 3373, Biological Substance, Category B or UN 3245, Genetically modified organisms

80. 80 Record Keeping When shipping hazardous materials, you are required to keep copies of documentation for a period of at least two years. These records may be inspected by several federal agencies, including the DOT and the FAA.

81. 81 Incident Reporting DOT requires that any release of an infectious substance (Category A or B) in any mode of transportation be reported. Contact EH&S at 255-3201 to notify immediately.

82. 82 International Shipping & Regulations…

83. 83 The transport of Infectious Substances on board an aircraft in checked or carry-on baggage or on a person is strictly prohibited and is enforced by international air carriers. International Travel

84. 84 International regulations are not meant to supersede any local or national laws Copies of these documents are available through the Environmental Health and Safety department.

85. 85 Consignee Responsibilities Obtain an import permit as necessary   you may still need to apply for the appropriate import, export, Material Transfer Agreement for the transport of these agents. Check with the Technology Transfer Office - https://www.cu.edu/techtransfer/, and   check with the Office of Research Integrity and Regulatory Compliance – Export Control Guidance Provide the shipper with a copy of the permit Ensure someone will be available to receive the package Let the sender know that the package arrived safely

86. 86 More Stringent Regulations Each country or “state” may adopt more stringent regulations Operator Variations - Every airline is allowed to adopt more rigid regulations in place Shipper’s Declaration - MUST be written in English (may also include the country of origin’s language as prescribed by national/local laws)

87. 87 Refrigeration When scheduling the shipment, keep in mind that over a long distance, replenishing of dry ice may be necessary is dry ice available enroute? can someone (typically a courier agent) replenish dry ice Use ice packs instead of wet ice PREVENT leaky packages freeze in -70 freezers to extend life

88. 88 A final reminder why these regulations exist….

89. 89 I think I’m done! Please Take Quiz