Supply List for Shipping Class 6.2 Biological Substances Type B Packaging (TC-123-1B marking and UN3373) Can only be used for Category B biological materials (see next page). Leakproof Bag Individually wrapped primary containers can be placed in this leak-proof bag with absorbent material. In sufficient quantity to absorb the entire contents. Pressure- (95 kPa) and Temperature- Tested (-40C to 55C) Bag This bag has been tested for air travel conditions. This should be the final container the supplies are placed in. An itemized list must be placed between this bag and the outer Type B Packaging. 1 General Guidelines for Classifying Class 6.2 Biological Substances Risk Group 1 Shipment of Risk Group 1 biological substances does not require special shipping packaging but it will require paperwork. Contact HSE and Science Stores immediately. If you are shipping specimens on dry ice, the dry ice within the package will be considered a Class 9 – Miscellaneous dangerous good regardless of what is being shipped with the ice. See below for more details. Risk Group 2 If you are shipping Risk Group 2 biological substances contact HSE immediately. Shipping dangerous and restricted goods can take time (approximately 1 week) as each sample must be classified and packaged individually. Are the appropriate packaging supplies even on campus? Have you purchased these? In December 2015, the University of Regina will not be able to send pathogens to an organization without formal confirmation from the organization’s BSO and demonstration of the recipient organization’s Public Health Agency of Canada License. Figure 1. Flowchart of Decision-Steps to Classify Biological Substances Packaging for Shipping Toxic Substance Class 6.1 Infectious Substance Category A (Infectious) Category B (Biological) Class 6.2 UN 2814 or UN 2900 Class 6.2 UN 3373 Type 1B Type 1A By ground By air + IATA Regs 2 Step 1 – Is the material a toxic or infectious substance? Definitions Toxic Substances are defined as substances that are liable to cause death or serious injury or harm human health if swallowed or inhaled or if they come into contact with human skin (LD50 and LC50). If you have a toxic substance (Class 6.1) this Guide does not apply, contact the BSO immediately. Infectious Substances are defined as a substance known or reasonably believed to contain viable micro-organisms such as bacteria, viruses, rickettsia, parasites, fungi, and other agents such as prions that are known or reasonably believed to cause disease in human or animals. Anything in Risk Group 2 qualifies as an ‘Infectious Substance’ (Class 6.2). Step 2 – Is the infectious substance, Category A, B, or Exempted? To determine whether an organism is Category A or B, we have to consult Part 2, Appendix 3 of the TDG Regulations: (http://www.tc.gc.ca/eng/tdg/clear-part2-339.htm#app3). Category A (Infectious) – An infectious substance in a form that, when exposure to it occurs, is capable of causing permanent disability, life-threatening, or fatal disease to humans or animals. If there is any doubt as to whether or not a pathogen falls within this category it must transported as Category A, Infectious Substance. Examples: Viruses o Human Immunodeficiency Virus o Rabies Virus o Hepatitis B o Hantaviruses Bacteria o E.coli ETEC o Mycobacterium tuberculosis Category B (Biological) – An infectious substance that does not meet the criteria for inclusion in Category A. Examples: Viruses o Hepatitis C and D Bacteria o Pseudomonas aeruginosa o Staphylococcus aureus o E.coli, E.coli EIEC, E.coli EPEC Fungi o Aspergillus nidulans Category B (Exempted) - Human Specimens Not Believed to Contain Infectious Substances. If you don’t know that is not reason enough. Examples: Blood, urine, tissue 3 Example of Shipping a TDG, Class 6.2 Substance This is an example to demonstrate how a microorganism is classified and the process to determine the packaging, labeling, and documentation requirements. In this example scenario, we have a culture of Escherichia coli which we wish to send to a colleague elsewhere in Canada. 1. Does it qualify as an ‘Infectious Substance’? Risk Group 1 materials and organisms are exempt from TDGR and can be shipped by road without training or special packaging. Anything in Risk Group 2 qualifies as an ‘Infectious Substance’. In the example of E. coli, it is an ‘infectious substance’ because E. coli is a Risk Group 2 organism. 2. Is it ‘Category A’ or ‘Category B’? To determine whether an organism is Category A or B, we have to consult Appendix 3 of the TDGR: (http://www.tc.gc.ca/eng/tdg/clear-part2-339.htm#app3). E. coli is listed under Category B. Category A materials are those that could cause permanent disability or life threatening disease in animals or humans. All infectious substances that don’t meet the Category A (high risk) criteria are captured under Category B. 3. What is the correct shipping name – UN3373, UN2814 or UN2900? Anything in Category B is shipped under the name UN3373, Biological Substance, Category B. This would be the correct shipping name for our example shipment of an E. coli culture. Category A materials are assigned to either UN2814 or UN2900, Infectious Substance, depending on the ability of the organisms to cause disease in humans or animals. You are not certified to classify, package, or ship dangerous or restricted goods. Please contact HSE and Science Stores immediately. It can take 1 -2 weeks to classify and acquire the proper shipping supplies, please start this process EARLY. 4