Shipping Biological Substances at the University of Regina – Class 6.2 Health, Safety & Environment Human Resources 1 Introduction This document has been created as a quick reference document to inform you on how to ship biological substances (non-dangerous goods & dangerous goods) at the University of Regina (U of R). If any of your questions are not answered in this guide or you would like further information, please do not hesitate to contact: Have questions? Phone, email, or text message! Biological Safety Officer Tianna Gross Tianna.Gross@uregina.ca Lab Safety Coordinator Sarah Posehn Sarah.Posehn@uregina.ca 306-585-5198/ 306-527-4320 (c) 306-337-3184/ 306-550-8358 (c) health.safety@uregina.ca Health, Safety & Environment The role of the Biosafety Officer (BSO), a member of the Health, Safety & Environment (HSE) Unit, is to provide professional advice and assistance in all matters related to biological substance safety and to coordinate administration of the Biosafety Program. HSE welcomes the opportunity to assist and support your exciting biologically hazardous research activities at the U of R. Resources U of R Biosafety Program The Biosafety Program provides a comprehensive guide for all activities on and off campus involving the use of biological materials or organisms (including animals). Access online: http://bit.ly/biosafety Dangerous Goods – Class 6 – Toxic Substances and Infectious Substances The transportation of human pathogens and toxins within Canada fall under the Transportation of Dangerous Goods (TDG) Regulations, Class 6. TDG covers dangerous goods during transport and WHMIS covers hazardous materials in the workplace. Each biological substance to be shipped needs to be individually risk-assessed and classified prior to shipping. The below information is to be used as a guide. 2 You may not physically offer/ ship dangerous goods, this must be done by Science Stores personnel or Health, Safety, & Environment. You may complete the courier documents and package the supplies using the below Guide, but the physical package must be packaged offered to the courier by personnel trained in TDG. Reviewing this Guide does not constitute training; you must successfully complete an approved course and obtain a certification card from Health, Safety & Environment. Risk Group 1 Shipment of Risk Group 1 biological substances does not require additional paperwork, approval, or special shipping packaging. However, 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 the Biosafety Officer (BSO) immediately (contact information is listed above). Shipping dangerous goods can take time (approximately 1 week) as each sample must be classified and packaged individually. Are the appropriate packaging supplies on campus? 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 3 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 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 (cultures) o Influenzavirus A, B, and C, Avian o Human Immodeficienty Virus o Rabies Vrius o West Nile Fever Virus o Hepatitie B o Hantaviruses Bacteria (cultures) o Mycobacterium tuberculosis Category B (Biological) – An infectious substance that does not meet the criteria for inclusion in Category A. Specimen is a part of a thing intended to show kind and quality of the whole. A Culture is when a specimen is placed upon a suitable culture to promote growth. (Definitions from Regina Qu’Appelle Health Region) Examples: Viruses (specimens) o Influenzavirus A, B, and C, H1N1 o Human Immodeficienty Virus o Rabies Vrius o Hepatitis A, B, C and D Bacteria (cultures) o Mycobacterium tuberculosis o Staphylococcus Aureus (MRSA) 4 Category B (Exempted) - Human Specimens Not Believed to Contain Infectious Substances. Examples: Blood, urine, tissue Step 3 – What size package will be shipped? Small means of containment (SMoC): capacity < 450L and requires labels (see below) Large means of containment (LMoC): capacity > 450L and requires placards Step 4 – What type of package will be shipped? The packaging must protect the material from damage during shipping. You will need to consider how the dangerous good is couriered - by ground, air, rail, or ship? Majority of the U of R packages will be shipped by air or ground, but the package requirements do differ. For ground shipping, the packaging must conform to UN requirements. For air transport, the packaging must meet the criteria of the International Civil Aviation Organization (ICAO). Figure 2. Schedule 1 of the TDG Act; providing detail on handling Class 6.2 substances No amount of UN2814 can be shipped as a limited quantity (Column 6) Maximum amount of Class 6.2 Category A that can be shipped in one consignment on a passenger carrying rod vehicle is 50 mL. Maximum amount of Class 6.2 Category B that can be shipped in one consignment on a passenger carrying road vehicle is 4 L. 5 Figure 3. Section 5 of the TDG Act; indicating the requirements for packaging/ means of containment for Class 6.2. (1) A person must handle, offer for transport or transport dangerous goods included in Category A or Category B of Class 6.2, Infectious Substances, in a means of containment listed for them in column 2, 3 or 4 of the table (shown below) to this section (2) Despite subsection (1), a Type 1A means of containment may be used in all cases. Col. 1 Category Category A Col. 2 Means of containment for cultures 1A Col. 3 Means of containment for diagnostic specimens or clinical specimens 1B except for the following substances which must be contained in a 1A means of containment: (a) Crimean-Congo Hemorrhagic fever virus; (b) Ebola virus; (c) Flexal virus; (d) Guanarito virus; (e) Hantaan virus – Hantaviruses causing hemorrhagic fever with renal syndrome; (f) Hantaviruses causing pulmonary syndrome; (g) Hendra virus; (h) Herpes B virus (i) Junin virus; (j) Kyasanur Forest disease virus; (k) Lassa virus; (l) Machupo virus; (m) Marburg virus; (n) Monkeypox virus; (o) Nipah virus; (q) Omsk hemorrhagic fever virus; (p) Russian Spring-summer enephalitis virus (r) Sabia virus; and (s) Variola virus. Col. 4 Means of containment for infectious substances intended for disposal 1C except for the following substances which must be contained in a 1A means of containment: (a) Crimean-Congo Hemorrhagic fever virus; (b) Ebola virus; (c) Flexal virus; (d) Guanarito virus; (e) Hantaan virus – Hantaviruses causing hemorrhagic fever with renal syndrome; (f) Hantaviruses causing pulmonary syndrome; (g) Hendra virus; (h) Herpes B virus (i) Junin virus; (j) Kyasanur Forest disease virus; (k) Lassa virus; (l) Machupo virus; (m) Marburg virus; (n) Monkeypox virus; (o) Nipah virus; (p) Omsk hemorrhagic fever virus; (q) Russian Spring-summer enephalitis virus (r) Sabia virus; and (s) Variola virus; Category B 1B 1B 1C 6 Type 1A The highest level packaging you can buy commercially that has undergone various tests to verify it is durable. It can be used to ship via air or ground. Watertight primary and secondary containers Adequate quantity of absorbent material to absorb the entire contents of the inner packaging Wrapping to prevent primaries from coming in contact with each other Strong outer packaging suitable for its intended use Meets specific testing requirement Safety Marks/ Labels o Diamond-shaped Class 6.2 o UN 2814: Used for infectious substances that are considered human pathogens only or pathogens that infect humans and animals. Proper shipping name: INFECTIOUS SUBSTANCES, AFFECTING HUMANS (name of pathogen). o Or UN 2900: Used for infectious substances that are considered pathogens for animals only. Proper shipping name: INFECTIOUS SUBSTANCES, AFFECTING ANIMALS (name of pathogen). o Orientation label (if liquid) o Certification Safety Mark “TC-125-1A” o Manufacturer’s address o Shipper’s address o 24-hour CANUTEC# or 24/7 Emergency Number 7 Shipping Documents: Needed Figure 4. Example of Shipping Document needed for Category A, Type 1A Packaging Type 1B For the majority of biological shipments at the University of Regina, Type 1B packaging is adequate. The marking ‘TC125-1B’ indicates a packaging system meets the requirements for Type 1B (minimum size and withstanding a 1.2 meter drop test). In order to ship materials by air, a leak-proof pressure- and temperature-tested container must be used as a secondary container. You can purchase these supplies from a commercial supplier or contact the BSO for access to ambient temperature supplies rated for air transport. Leak proof primary and secondary containers Adequate quantity of absorbent material to absorb the entire contents of the inner packaging Wrapping to prevent primaries from coming in contact with each other Itemized list of contents - Shipping Documents: Not Needed Safety Marks/ Labels o Diamond-shaped UN3373 8 o o o o Biological Substance, Category B Certification Safety Mark “TC-125-1B” Shipper’s name and address 24-hour CANUTEC# or 24/7 Emergency Number Exemptions: Specimens Believed Not to Contain Infectious Substances The means of containment must be marked with the words “Exempt Human Specimen” that is Type 1B or Type 1C – so that under normal conditions of transport, including handling, there will be no release of the specimen. Step 5 – Do the samples need to be on dry ice or over-packed? Dry Ice Regulations do not apply to UN1845, CARBON DIOXIDE, SOLID or DRY ICE transported by road vehicle and used as a refrigerant in a small means of containment if: The shipper includes on an accompanying document the words “dry ice as a refrigerant;” and The SmoC in which the dry ice is used as a refrigerant permits the release of carbon dioxide to prevent the build-up of pressure that could rupture the SMoC If transported by air, regulations apply. Over-Packing 9 If several triple-packed 1A or 1B packages are combined into one large package, each package inside the over-pack must be properly marked and labeled. Maximum quantity of DGs allowed in each 1A package is 50 mL. Only one 1A package is allowed in the over-pack. The outside of the over-pack must: o Bear the same markings and labels as the inside packages Addresses – Shipper and receiver Class 6.2 hazard label Proper shipping name, UN number label Directional arrows o Be marked with the word “over-pack” If the DGs are being shipped on dry ice, place 1A or 1B packages into a Styrofoam icebox and place the dry ice around the packages. o Proper shipping name for dry ice, if being used. Step 6 – What Additional Markings and Labels are required? ERAP must be place for any amount of Category A that falls under the ERAP restricted organisms. To determine whether an organism is restricted, we have to consult Appendix 3 of the TDG Regulations: (http://www.tc.gc.ca/eng/tdg/clear-part2-339.htm#app3). It is the responsibility of the shipper to ensure that all packages containing dangerous goods are properly labeled and marked. If any of these safety marks are lost or damaged during transport, the carrier must replace them. Once the shipper determines which labels are required, it is important that they be visible during shipping. The label must never be placed on the bottom of the package. For a small package, only one label or sets of labels is required as long as it is visible. The shipper must provide some basic information about the DGs. The hazard label (both primary and subsidiary classes), shipping name, and UN number must appear of the outside of the package. Containers of liquid dangerous goods should be transported in an upright position. In the case of Infectious Substance, Category B, the means of containment must be at least 100x100 mm and the shipping name must be 6mm high or more. Requisitions or paperwork should be put into a plastic bag and stored between the secondary and outer container during shipment. TDG Example of Shipping an Infectious Substance 10 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 documentation or training. 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. 4. What type of packaging is needed? There are two types of packaging: the highest level, Type 1A, is packaging you can buy commercially that has undergone various tests to verify it is durable - it is only required for Category A infectious substances (although it can be used for lower risk, Category B shipments). In our example, E. coli is Category B, so Type 1B packaging is required. 5. What labels are required? The labeling requirements are dictated by the classification of the contents. Shipments of Category B Infectious Substances must have diamond hazard label shown below on the outer container. UN3373 They must also have the shipping name written at least 6 mm high: Biological Substance, Category B. In the case of Category B materials, a 24-hour emergency response number must also be written. For example: ‘24 Hr Number: CANUTEC 613-996-6666’ or the BSO Number. 6. What documentation is needed by the carrier? Shipments of Biological Substance, Category B are exempt from documentation requirements, providing the outer package is at least 10 cm x 10 cm and meets the packaging certification and labeling requirements described above. 7. Are placards required on the outside of the vehicle? Placards would not typically be required for a shipment of a culture of E. coli. In fact, in general, for the size of shipments the University of Regina would send out, placards are not necessary. 11 Step-by-Step Instructions on How to Prepare a UN3373 Biological Substance, Category B Package (Triple Packing) 1) Individual sample containers (primary receptacles) may be glass, metal, or plastic. Positive means of ensuring a leak-proof seal, skirted stopper, or metal crimped seal must be provided. Reinforce screw caps with adhesive tape. Liquids: Individual primary receptacles must be leak-proof and must not contain more than 1L. Solids: Individual primary receptacles must be sift proof and not exceed outer packaging weight limit. 2) To prevent contact between multiple primary receptacles, individually wrap or separate each receptacle. 3) Place secure, separated primary receptacles into the leak-proof secondary container (pictured below). Biohazard sticker must be on bag. 4) Place enough absorbent materials (strips, paper towels, etc.) in bag to absorb the entire contents of all primary receptacles. (1 absorbent strip will absorb 11 mL blood and 30 mL urine). 5) Place this packed secondary container into the 95 kPa tested (meets IATA and ICAO air transport requirements) plastic secondary container (pictured below). Sticker label must be on bag. 6) Enclose an itemized list of contents – either, in the pouch on the outside of the pressure-tested bag or between the secondary packaging and the outer box. 7) Place double-bagged receptacle inside sturdy outer packaging marked TC-125-1B (pictured below). Outer packaging must be larger than 18cm x 10 cm x 5 cm. Liquids: The outer packaging must not contain more than 4 L. Solids: The outer packaging must not contain more than 4 kg. 12 8) Safety Marks/ Labels that must be placed on box in visible locations (not bottom, or covered by Courier Address). Diamond-shaped UN3373 Biological Substance, Category B (at least 6mm high) Certification Safety Mark “TC-125-1B” Shipper’s name and address 24-hour CANUTEC# or 24/7 Emergency Number (306.527.4320) 13 Example of Shipping Documentation CLASS 6.2 GROUND SHIPPING DOCUMENT DATE SHIPPING NO. FROM TO Contact person: ___________________________ Contact person: _______________________________ Phone number: ___________________________ Phone number: ________________________________ UN or ID No. UN 2814 UN 1845 PROPER SHIPPIING NAME INFECTOUS SUBSTANCES AFFECTING HUMANS Specimen Culture DRY ICE as refrigerant Non-regulated CLASS Division CATEGORY/PACKING GROUP MASS OR VOLUME PACKING INST. 6.2 Category A ____ mls 602 9 III 20 kg Overpack used 904 # of PKGS 1 This is to certify that the above named articles are properly classified, described, packaged, marked, labeled and are in proper condition for transportation according to the Transportation of Dangerous Goods Regulations. IF PACKAGE IS DAMAGED, IMMEDIATELY TELEPHONE CANUTEC (613) 996-6666 24 HOUR CONTACT NUMBER: 1-123-456-7890 ERAP #ERP2-0746 Phone 1-800-545-7661 Received in apparent good order: ____________________________________________ (Consignee’s Signature) Received in apparent good order: ____________________________________________ (Carrier’s Signature) 14 Shipping Document Legend Date Date the shipping document was prepared or given to a carrier Shipping number This is for tracking purposes. Any numbering system will do, but it MUST be on the shipping document. Consignor Consignor’s name, address, and phone number Consignee consignee’s name, address, and phone number. NOTE: When shipping Category A and Category B, the document must have a contact person identified for both the consignee and consignor. UN number Infectious Substance is UN2814 Proper Shipping Name INFECTIOUS SUBSTANCE, AFFECTING HUMANS is the shipping name Dry Ice - when Dry Ice is used along with the infectious substance, the ground document must state “Dry Ice as Refrigerant”. Class/Division Infectious Substances is Class 6.2 Category/ Packing Group Category A or B must be documented, based on severity of disease, route of infection, virulence, infectivity. The packing group for a substance may be preceded by ‘PG’ Mass or Volume Total mass or volume of package( i.e. 50 mL or 50 g). ‘OVERPACK used’ must be inserted after all relevant entries relating to the packages within each overpack. Packing Instruction Number of packing instruction Number of Packages Number of packages being sent with the same document Contact Canutec In the event of an accidental release, the person in possession of Class 6.2 Infectious Substances, must make an immediate report to CANUTEC (613) 9966666. 24-hour contact number This number must be a contact from whom technical information can be obtained about the dangerous goods in transport, without breaking the telephone connection. It must be a number that can be reached 24 hours each day. You may use CANUTEC’s number after you have contacted them and received written permission. This can be done at no cost to the consignor. Additional Handling Information Emergency Response Assistance Plan – issued by Transport Canada. When shipping Category A (*) infectious substances, the ERAP reference number, # ERP2-0746 and phone number 1-800-545-7661, must be provided on the documentation. 15