Packaging and Shipping of Infectious Substances Recertification 2012

1. Packaging and Shipping of Infectious SubstancesRecertification 2012 Alabama Department of Public Health Bureau of Clinical Laboratories Jeannine Parker, Trainer

2. Objectives • Review additions and changes to the IATA and DOT regulations. • Review how to classify, mark, label, and document Division 6.2 Hazardous Materials (Infectious Substances tagged UN 3373 and UN 2814). • Review the training requirements of DOT and IATA and how those requirements relate to anyone who packages and ships certain laboratory specimens. • Review the exceptions to the regulations and list when they can be used.

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 • 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

4. Training Curricula • General Familiarization • Familiar with the general provisions of the regulations • Function Specific Training • Detailed training in the requirements applicable to the function for which that person is responsible • Safety Training • Hazards presented by dangerous goods, safe handling, and emergency response procedures • OSHA Training may substitute for this training

5. Function Specific Training • This training is for Packaging and Shipping of Infectious Substances • Not gasoline • Not oil • Not explosives • Not gases • Just Infectious Substances

6. Safety Training • Includes • Safe handling • Hazards • Emergency response in the event of an incident • Security Training • Awareness of security risks associated with dangerous goods transportation

7. Training • IATA 1.5 Training Requirements • 1.5.0.2 Personnel identified in the categories specified… must be trained or training must be verified prior to the person performing any duty specified… • 1.5.0.3 Recurrent training must be provided within 24 months of previous training to ensure knowledge is current. • 1.5.0.4 A test must be provided following dangerous goods training to verify understanding of the regulations.

8. Training, cont’d • 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

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

10. Training, cont’d • Recordkeeping • Record of Training • Employee name • Most recent date trained • Description of training • Description of training materials/where kept • Name and address of trainer • Record of training kept as long as employed

11. 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 .

12. 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)

13. 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

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

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

16. IATA Dangerous Goods Regulation • Applicability – applicable to any dangerous good that will travel by air • Limitations – Forbidden/Hidden Dangerous Goods as well as Exceptions for small quantities (none for Infectious Substances) and Limited Quantity Exceptions (no provisions for Infectious Substances), USG-01 Variation: comply with DOT regulations • Classification – Classifying the hazardous material • Identification – Identifying the material as per Proper Shipping Name and related Technical Name • Packing – selecting the proper packaging and using it according to manufacturer's instructions

17. DOT Regulations • CFR Title 49 Transportation • Parts 100-185 comprise the Hazardous Materials Regulations (HMR) • Governs the shipment of all dangerous goods that transit through the US by any mode (rail, air, road, sea, etc.) • HMR based on the UN Model Regulations

18. 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

19. 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

20. 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

21. 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

22. 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

23. 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

24. 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)

25. 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

26. 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

27. 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

28. 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)

29. 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.

30. 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

31. 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:

32. 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

33. 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.

34. 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

35. 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.

36. DOT Motor Vehicle Exception • “A Division 6.2 material, other than Category A Infectious Substance, contained in a patient sample being transported for research, diagnosis, investigational activities, or disease treatment or prevention, or a biological product, when such materials are transported by a private or contract carrier in a motor vehicle used exclusively to transport such materials. Medical or clinical equipment and laboratory products may be transported aboard the same vehicle provided they are properly packaged and secured against exposure or contamination.” 49 CFR 173.143(b)(10)

37. 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

38. 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 (Suspect Category A, Infectious Substance)

39. Proper Packaging • 6.2 Packaging must • Be Tested • Meet regulatory specifications • Be certified • Used as a unit • Be marked with appropriate certification markings

40. Proper Packaging • 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

41. Proper Packaging • 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 • Must have a positive means of securing the top, i.e., parafilm or tape

42. Proper Packaging • 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.

43. Proper Packaging • 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

44. Proper Packaging • 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)

45. 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….”

46. 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 • Positive means of securing the top, i.e., parafilm or tape • 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

47. Proper Packaging

48. Packing Instructions (PI) • Category A PI 620 • 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 or Suspect Category A Infectious Substance • Number of vials/tubes/etc. included

49. 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

50. Category A, 6.2 Packaging