Recertification Presentation for Packaging and Shipping of Infectious Substances May 17, 2011

1. Recertification Presentation for Packaging and Shipping of Infectious SubstancesMay 17, 2011 Alabama Department of Public Health Bureau of Clinical Laboratories Jeannine Parker, Trainer

2. Objectives • Review the regulators and their respective regulations, and their roles within their respective jurisdictions • Classify, mark, label, and document Division 6.2 Hazardous Materials (Infectious Substances tagged UN 3373 and UN 2814 • Review regulatory requirements for UN 2814 and UN 3373 hazardous materials packaging • Review Packing Instructions for UN 2814 and UN 3373 hazardous materials

3. General Philosophy • Before any package of dangerous goods is offered for air transport, the shipper must comply with certain requirements: • Information must be provided so you can carry out your responsibilities as a shipper • One must ensure that the article is not prohibited from air transport

4. General Philosophy • Before packaging and shipping, all relevant personnel must have received training in accordance with their responsibilities • All dangerous goods are packed in compliance with the regulations

5. Training • This recertification training meets the requirement for recurring training every two years (IATA) and every three years (DOT) • This training is for those people who have been previously certified • This training will have a general overview of the regulations and cover the changes that IATA has instituted as of January 1, 2011

6. Regulators/Regulations • United Nations • UN Committee of Experts (UNCOE) writes the UN Recommendations on the Transport of Dangerous Goods Model Regulations. • 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 the Safe Transport of Dangerous Goods by Air .

7. Regulators/Regulations • International Air Transport Association (IATA) • Promulgates the Dangerous Goods Regulation (DGR), based on the Technical Instructions from ICAO, and is printed every January. • 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)

8. Regulators/Regulations • 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

9. Shipper’s Responsibilities • You are ultimately responsible for the package from beginning to end

10. What are your Responsibilities? • Classify • Identify • Pack • Mark & Label • Document (if required)

11. Classification • So, just what are dangerous goods? • IATA says: • “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 these regulations or which are classified according to these regulations” IATA DGR 1.0

12. Classification • DOT says: • “a substance or material that the Secretary of Transportation has determined is capable of posing an unreasonable risk to health, safety, and property when transported in commerce, and has been designated as hazardous under section 5130 of Federal Hazardous Materials Transportation Law (49 U.S.C. 5130).” 49 CFR 105.5

13. How do you Classify your Substance? • Definition of an Infectious Substance • 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 3.6.2.1.1

14. 9 Hazard Classes 1 Explosives 2 Gasses 3 Flammable liquids 4 Flammable solids 5 Oxidizing substances 6 Toxic/Infectious 7 Radioactive 8 Corrosive 9 Miscellaneous

15. Class 6 Toxic and Infectious Substances • Class 6 is divided into two Divisions • 6.1- Toxins/Poisons • 6.2- Infectious Substances • Division 6.2 is divided into two categories • Category A Infectious Substances • Category B Biological Substances

16. Other Recognized Categories • Human Exempt • Specimens with minimal likelihood of a pathogen • Genetically modified organisms and micro-organisms (GMOs) • Pathogenic GMO must be designated Category A or B • Non-pathogenic GMO • Medical or clinical wastes

17. Definitions • 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 (Technical Name)

18. Definitions • Category B – assigned UN 3373 • 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. • Proper Shipping Name is Biological Substance, Category B

19. Some Other Definitions • Patient Specimen • are those collected directly from humans or animals, including, but not limited to, excreta, secreta, blood and its components, tissue and tissue swabs, body parts being transported for purposes such as research, diagnosis, investigational activities, disease treatment and prevention. IATA 3.6.2.1.4

20. Definitions • Cultures • Are the result of a process by which pathogens are intentionally propagated. This definition does not include patient specimens as defined in 3.6.2.1.4. IATA 3.6.2.1.3

21. Category A • 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 (Technical Name)

22. Table 3.6.D Table 3.6.D is not exhaustive. Infectious substances which do not appear in the Table but do meet the criteria for inclusion, must be assigned Category A.

23. Category B • UN 3373 • 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. • Proper Shipping Name is Biological Substance, Category B

24. Exempt Human Specimen Category • “Patient specimens for which there is minimal likelihood that pathogens are present are not subject to these regulations if the specimen is packed in a packaging which will prevent any leakage and which is marker with the words “Exempt Human Specimen” or “Exempt Animal Specimen”, as appropriate. The packaging must meet the following conditions:

25. Exempt Human Specimens • The packaging must consist of three components: • A leak-proof primary receptacle • A leak-proof secondary packaging • An outer packaging of adequate strength for its capacity, mass, and intended use, and with at least one surface having minimum dimensions of 100 mm X 100 mm

26. Exempt Human Specimens • For liquids, absorbent material in sufficient quantity to absorb the entire contents must be placed between the primary receptacles and the secondary packaging, so that, during transport, any release or leak of a liquid substance will not reach the outer packaging and will not compromise the integrity of the cushioning material • When multiple fragile primary receptacles are placed in a single secondary packaging, they must be either individually wrapped or separated to prevent contact between them.

27. Non-Regulated Material • Substances which do not contain infectious substances or substances which are unlikely to cause disease in humans or animals • Substances which contain micro-organisms which are non-pathogenic to humans or animals • Substances in a form that any present pathogens have been neutralized or inactivated such that they not longer pose a threat

28. Non-Regulated Material • Environmental samples (including food and water samples) which are not considered to pose a significant risk of infection • Dried blood spots collected by applying a drop of blood onto absorbent material, or fecal occult blood screening tests and blood or blood components which have been collected for the purpose of transfusion or for the preparation of blood products to be used for transfusion or transplantation and any tissues or organs intended for use in transplantation.

29. Dry Ice UN 1845 • Class 9 Miscellaneous • Packing Group III – low danger • Three packing groups, from high (PG I) to low danger • Packing Groups so not apply to Infectious Substances • Packing Instruction 954 • Package must allow for the release of gas (CO2) • Proper shipping name and weight in kilograms must appear on the package

30. Identification • Assigning a Proper Shipping Name to a Dangerous Good • Proper Shipping Name (PSN) for 6.2 Category A : • Infectious Substance, affecting humans • Assigning a four digit ID number by the UN • UN 2814 (Cat A) • UN 3373 (Cat B) • UN 2900 (animals) • UN 1845 (dry ice) • Some DGs require a Technical Name, listed in parentheses, after the PSN

31. List of Dangerous Goods

32. Proper Packaging • UN 2814 Packaging must • Be Tested • Meet regulatory specifications • Be certified • Used as a unit • Be marked with appropriate certification markings

33. Proper Packaging for UN 2814 • Triple packaging concept • Primary receptacles must be leak-proof • Secondary packaging must be leak-proof and meet the regulation for pressure differential • Outer packaging must meet the regulations for • Leakage • Sturdiness • Rigidness • markings

34. Proper Packaging for UN 2814 • Leak-proof Primary Receptacle • Blood tubes • Urine transport tubes • Media slants • Metal-crimped glass vials • Must be cushioned if more than one primary in a secondary package • Liquid contents primaries must have sufficient absorbent material to absorb the entire contents if the primary breaks during transport

35. Proper Packaging for UN 2814 • Secondary Packaging • Must be leak-proof • Must be able to contain the contents of the primaries • Either Primary or Secondary must be able to withstand an internal pressure differential of 95 kPa in a temperature range of -40°C to 55°C.

36. Proper Packaging for UN 2814 • Outer Package • Must meet the design type testing requirements • Drop test of 9 m • Puncture test of steel rod, weighing 7 kg, dropped from 1 m w/ intent to rupture primary • Water spray of 5 cm/hr for one hour before the drop test • Must be rigid and of adequate strength for its capacity, weight, and intended use • Must bear the UN Specification Mark 4G/Class 6.2/02 USA/+AX1852 • Must be labeled properly U N

37. Proper Packaging for UN 2814 • Entire UN certified 6.2 package must be used as an entire unit • No substitutions of secondary packaging • Should not add or cover up the 6.2 label • Name and telephone number of the Responsible Person must appear on the outer package • Smallest dimensions at least 100 mm X 100 mm (4 inches)

38. Proper Packaging • Category B • “packaging must be of good quality, strong enough to withstand the shocks and loadings normally encountered during transport…Packaging must be constructed and closed so as to prevent any loss of contents….”

39. Proper Packaging • Category B • Must use the triple packaging concept • Primaries must be leak-proof • cushioned such that breakage cannot occur • Primaries that contain liquid must have sufficient absorbent material to absorb the entire contents of the primaries • Secondary packaging must be leak-proof • Secondary must meet the pressure differential requirement • Unit must withstand a drop test of at least 1.2 m

40. Proper Packaging

41. Packing Instructions (PI) • Category A PI 620 (CHANGE) • Triple packaging concept • Primary receptacles must be leak-proof • Secondary packaging must be leak-proof and meet the regulation for pressure differential • Itemized List of Contents must be included between secondary and outer packaging • Proper Shipping Name • Number of vials/tubes/etc. included

42. Packing Instructions (PI) • Category A PI 620, cont’d • Outer packaging must meet the regulations • Unit packaging must be used as a unit Fragile primaries must have cushioning and/or absorbent material (or both if liquid) and the absorbent material must be sufficient to absorb all the contents of the primaries if they break • Must not pack other materials in with Category A

43. Category A, 6.2 Packaging

44. Packing Instructions (PI) • Category B PI 650 • Triple packaging required • Primary receptacles must be leak-proof • Primary receptacle must be packed in secondary packaging …so that they cannot break, be punctured, or leak • Secondary packaging must be leak-proof and meet the regulation for pressure differential • Itemized list on contents between primary & secondary • Proper Shipping Name • Number of vials/tubes/etc. included

45. Packing Instructions (PI) • Category B PI 650, cont’d • Leakage from a primary cannot compromise the integrity of the cushioning material or the outer package • Fragile primaries must have cushioning and/or absorbent material (or both if liquid) and the absorbent material must be sufficient to absorb all the contents of the primaries if they break

46. Category B Biological Substance

47. Dry Ice PI 954 • Dry ice must be placed outside the secondary but in the outer package • Support other than the dry ice must be provided for the secondary package • Packaging must be designed and constructed to permit the release of CO2 gas to prevent a build-up of pressure • Use a styrofoam-lined cardboard box for dry ice shipments

48. Quantity Limits • Category A • 50 ml/kg quantity limit on passenger airplanes • Category B • A single primary receptacle is limited to 1 L and the entire package must not exceed 4 L

49. Marking and Labeling • Packages are marked and labeled to give information about the contents, the hazard within, and any special handling requirements. • All markings and labels should be placed so they do not cover any other markings and labels. • Difference between a mark and a label

50. Marking and Labeling • Marking • Name and address of shipper (Phone # is recommended) • Name and address of the consignee (Phone # is recommended) • Name and telephone number of the Responsible Person (required for Cat A and recommended for Cat B) • Proper Shipping Name • UN ID number • Quantity of DG (required for Cat A and Dry Ice)