Packaging and Shipping Laboratory Specimens

1. Packaging and Shipping Laboratory Specimens Training and Update Information on the IATA Regulation Changes 2010

2. Objectives • Understand the training requirements of DOT and IATA and how those requirements relate to anyone who packages and ships certain laboratory specimens. • Identify the regulators and their respective regulations, and their roles within their respective jurisdictions.

3. Objectives, cont’d • Classify, mark, label, and document Division 6.2 Hazardous Materials (Infectious Substances tagged UN 3373 and UN 2814). • Have a working knowledge of the exceptions to the regulations and list when they can be used.

4. Who are the Regulators and What are their Regulations? • United Nations • UN Committee of Experts (UNCOE) • International Civil Aviation Organization (ICAO) • the specialized agency of the United Nations whose mandate is to ensure the safe, efficient and orderly evolution of international civil aviation. They are responsible for the Technical Instructions for aviation.

5. Who are the Regulators and What are their Regulations? • International Air Transport Association (IATA) • Promulgates the Dangerous Goods Regulation (DGR), based on the Technical Instructions from ICAO • IATA is organized in a two-tier format • Trade Association (technical, legal, financial, traffic services and most agency matters) • Tariff Coordination (passenger fares, cargo rates, and related conditions and charges)

6. Regulators, cont’d • US Department of Transportation (DOT) • Regulates any hazardous material traveling on the roadways, waterways, and railways of the US • Promulgates regulations to the Code of Federal Regulations (CFR) CFR Title 49 (specific for DOT) • US Postal Service (USPS) • Regulates all mail • Promulgates US Postal Regulations • New interim rule issued Nov 6, 2006 • Centers for Disease Control and Prevention (CDC) • Regulates any other area not covered by DOT or USPS • Promulgates regulations to the Code of Federal Regulations (CFR) CFR Title 42

7. Class 6, Division 6.2Definitions - IATA • Infectious Substances • Substances which are known or are reasonably expected to contain pathogens. Pathogens are micro-organisms (including bacteria, viruses, rickettsiae, parasites, fungi) and other agents such as prions, which can cause disease in humans or animals. IATA DGR 3.6.2.1.1 • If it meets the definition, it’s an A or B

8. Class 6, Division 6.2Definitions • Patient Specimen • Human or animal materials collected directly from humans or animals and transported for research, diagnosis, investigational activities, or disease treatment or prevention. Patient specimen includes excreta, secreta, blood and its components, tissue and tissue swabs, body parts, and specimens in transport media (e.g., transwabs, culture media, and blood culture bottles).

9. Class 6, Division 6.2Definitions • Culture • An infectious substance containing a pathogen that is intentionally propagated. Culture does not include a human or animal patient specimen.

10. Shippers’ Responsibilities • You are ultimately responsible for the package from beginning to end.

11. Shippers’ Responsibilities • Identify: is the material hazardous? • Classify: what kind of hazardous material is it? • Package: • Use certified packaging unit for 6.2 • Put the unit together using appropriate Packing Instructions (PI)

12. Shippers’ Responsibilities • Marking: Ensure all markings are proper • Labeling: Ensure all labels are correct • Document: • Complete the Shipper’s Declaration, if required

13. 1 Explosives 2 Gasses 3 Flammable liquids 4 Flammable solids 5 Oxidizing substances 6 Toxic/Infectious 7 Radioactive 8 Corrosive 9 Miscellaneous Nine Classifications of Hazardous Materials (all regs)

14. Class 6 • Class 6 is divided into two Divisions • 6.1- Toxins/Poisons • 6.2- Infectious Substances • Category A Infectious Substances • Category B Infectious Substances

15. Category A Infectious Substances • Category A – assigned UN 2814 • 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. • Proper Shipping Name • Infectious substance, affecting humans

16. Category B, Biological Substances • An infectious substance which does not meet the criteria for inclusion in Category A. Infectious substances in Category B must be assigned to UN 3373 except that cultures, as defined in 3.6.2.1.3, must be assigned to UN 2814 or UN 2900, as appropriate.

17. IATA and USPS Exemption • Exempt Human Specimens • A patient specimen unlikely to cause disease in humans or animals or for which there is only a minimal likelihood that pathogens are present • Subject to IATA and USPS packaging and marking requirements as • Exempt Human Specimen • DOT does not recognize this category

18. IATA Guidance Document • Pg 7

19. Category A Table • Table 3.6.D, IATA DGR • 49 listed organisms under UN 2814, Infectious Substances affecting humans • 14 listed organisms under UN 2900, Infectious Substances affecting animals The same list appears in the DOT and USPS regulations.

20. Class 6.2 Divisions • Classifying what you have: • This is a professional judgment call. Knowing the patient’s medical condition and status will determine how one decides to classify a substance.

21. Exempt Packaging Requirements • Three Components • A leak-proof primary receptacle • A leak-proof secondary packaging • An outer packaging of adequate strength… • For Liquids • Enough absorbent material around the primary receptacles to absorb the entire contents • For multiple primary receptacles, enough cushioning to prevent contact, rattling, and breakage

22. Packing • Triple Packaging Concept • Primary • Secondary • Outer packaging

23. Certified Packaging for Category A, Infectious Substances • UN 6.2 Packaging for Infectious Substances must meet certain requirements of the regulation • Test standards • Marking standards • Triple packaging system • Leak-proof primary • Leak-proof secondary • Certified outer packaging • Whole package must be used as a unit

24. Package Markings Category A • Manufacturers must mark their packages with • United Nations symbol • Packaging and construction code • “Class 6.2” • Last two digits of the year of manufacture • Country of manufacture • Certifying agency marks U N 4G/Class 6.2/02 USA/+AX1852

25. IATA Packing Instruction 602 Category A • Inner packaging • Watertight primary receptacle • Watertight secondary packaging • Must be able to withstand internal pressure producing a pressure differential of not less than 95 kPa (0.95 bar, 14 psi) • Must be capable of withstanding temperatures in the range of -40ºC to +55ºC

26. PI 602, cont’d • For liquid specimens, there must be sufficient absorbent material to absorb the entire contents of the primary receptacles should they break. For more than one primary, there must be cushioning between the receptacles. • List of contents of the secondary package must be included between the secondary package and the outer package and must include proper shipping name and technical name (eg.-Suspected Category A Infectious Substance).

27. PI 602, cont’d • Rigid outer packaging must meet requirements • All packages containing infectious substances must be marked with the NAME and TELEPHONE NUMBER of the Responsible Person.

28. Package Labels Category A • Infectious Substance Label • Class 9 label, if dry ice is used • Orientation arrows • Consignee name and address • Shipper name, address, phone number • Name and number of responsible person • Proper Shipping Name, UN number, quantity

32. A note about the 24-hr Emergency Response Number- • “This 24-hr number must monitored at all times the Hazardous Material is in transit. It must be monitored by a person who is knowledgeable of the hazards and characteristics of the Hazardous Material, have comprehensive emergency response and accident litigation information or immediate access to someone who possesses such knowledge and information.”

33. Documentation • http://www.fedex.com/us/services/pdf/ShippersDecColumnsColorPrinter.pdf?link=4

34. Packaging for Category BBiological Substances • Triple Packaging concept with some changes • Certified packaging is NOT required New marking, UN 3373 • No Declaration of Dangerous Goods required Biological Substance

35. IATA PI 650 • Good quality packaging, strong enough to withstand normal shocks and loadings… • Triple packaging concept • Water-proof primary and secondary receptacles • Rigid outer packaging, at least one surface must be 100 mm X100 mm (~4 in) • Primaries must be packed so that they should not touch, break, or leak, and if they do, the cushioning or outer package is not compromised

36. IATA PI 650, con’t • For liquid substances • Quantity limit of 1L / primary receptacle, 4 L / outer package • Primary and secondary must be able to withstand, without leaking, internal pressure of 95 kPa in the range of -40°C to +55°C. • Absorbent material between primary and secondary, sufficient to absorb entire contents of primary

37. IATA PI 650, con’t • For solid substances • Primary and secondary must be sift-proof • Quantity limit of 1 kg / primary receptacle, 4 kg / outer package • Cushioning between primaries if more than one

38. IATA PI 650, con’t • Itemized list of contents between secondary and outer packaging • Completed package must be able to withstand the drop test at 1.2 m. (3.9 ft.) • Markings • New diamond with UN number, UN 3373 • Proper shipping name must be adjacent to the diamond marking • Biological Substance

39. 2010 Changes to PI 650 • On the package: • Name & address of shipper • Name & address of consignee • Name & telephone number of responsible person (or on the airway bill) • UN 3373 Marking with Proper Shipping Name, Biological Substance, Category B • On the waybill • UN 3373 Biological Substance, Category B • Number of packages

40. IATA Packaging for Category B Infectious Substances

41. Quantity Limits for Infectious Substances • Category A, Infectious Substances • 50 ml or 50 g • Category B, Infectious Substances • 4 L or 4 kg

42. Shippers’ Responsibilities • You are ultimately responsible for the package from beginning to end.

43. Dry Ice on 6.2 Cat A • Use Class 9, Miscellaneous Hazard label • List Dry Ice on Declaration • In Proper Shipping Name column • Quantity in kilograms • Support inner packages • Allow for escape of CO2

44. Air Waybill

45. Air Waybill: Box 6 Special Handling

46. Training • …before a consignment of dangerous goods is offered for air transport, all relevant persons involved in its preparation, must have received training to enable them to carry out their responsibilities as detailed in Subsection 1.5 • IATA DGR 1.3.2.D

47. Training • Employer’s Responsibilities • Provide training or verify employee was trained • Test was given and passed • Document the training • Hazmat • Safety • Security • Certify employee trained

48. Training: Who Needs To Be Trained? • Any persons who: • Packages a hazardous material • 6.2 materials • Dry ice • Prepares materials or documentation • Classifies, documents a 6.2 material • Transports a hazardous material • Courier in a motor vehicle (exceptions) • Air plane • Vessel

49. Training • Training shall include the following: • General awareness/familiarization of the regulation • Function-specific training • Safety training • Emergency response • Protective measures • Proper procedures for handling hazardous material • Security Awareness

50. Training, cont’d • Initial and Recurrent • Trained within 90 days of employment • Retrained every two years for IATA, every three years for DOT • Training from a previous employer can be transferred to new job