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This bulletin explains the requirements related to the transportation of infectious substances. It does not change, create, amend or suggest deviations to the Transportation of Dangerous Goods (TDG) Regulations. For specific details, consult the TDG Regulations. An infectious substance, as defined under
Section 1.4 of the TDG Regulations, is a substance known or reasonably believed to contain viable micro-organisms, such as viruses, bacteria, parasites, fungi, and other agents, that are known or reasonably believed to cause disease in humans or animals. Substances classified as infectious substances may include blood, tissue, organs, body fluids, or cultures that contain pathogenic
microorganisms. A list of infectious substances, such as Ebola virus or Herpes B virus, can be found in Part 2 of the TDG Regulations under Appendix 3. Note: The table under Appendix 3 is not a complete list. If a substance is not listed
in the table, it is still considered an infectious substance when it meets the definition above and exhibits characteristics similar to an infectious substance on the list, such as: In addition to the TDG Regulations, other government departments regulate infectious substances. The
Public Health Agency of Canada (PHAC) administers regulations that apply to human pathogens in Canada, while the Canadian Food Inspection Agency (CFIA) regulates animal
pathogens. In addition, provincial governments may have additional regulations that pertain to infectious substances. As a consignor, you must comply with the requirements related to: Note 1: Placarding applies to the person transporting the infectious substance or to the person
loading the vehicle or large means of containment. Note 2: The primary class placard must be displayed when infectious substances are transported unless the placarding exemption is used and no ERAP is required (Section 4.16.1). Note 3: Placards and UN number are required when the shipment is transported in a large means of containment, and it
requires an ERAP in accordance with Part 7 of the TDG Regulations. Always assume training is required. The only time training is not required is when you are using an exemption (i.e., special case) which exempts you from Part 6 of the TDG
Regulations. You will find most exemptions in Part 1 of the TDG Regulations, from Sections 1.15 to 1.50. Employers are responsible for issuing a training certificate once their employee has received adequate training. The certificate must contain all of the information required
by Section 6.3 of the TDG Regulations. Even though there is no standard format, the TDG Directorate has a sample in the TDG Bulletin – TDG Training. Infectious substances are classified as Class 6.2, Infectious Substances, and are assigned to a category
(Category A or Category B) instead of a packing group. Infectious substances included in Category A are infectious substances that are transported in a form such that, when it is released outside of its means of containment and there is physical contact with humans or animals, it is capable of causing permanent disability or life-threatening or fatal disease to humans or animals. The proper shipping name of a Category A infectious substance is, as appropriate: Infectious substances included in Category B are infectious substances for which the likely consequences of an exposure during transport will not cause permanent disability and will not lead to fatality. The proper shipping name of a Category B infectious substance is:
Classification of patient specimensThe table below is a guide for classification of infectious substances contained in patient specimens. Table 1 - Classification of human or animal specimens
No reason to believeThe term “no reason to believe” means that sufficient information is available and none of it suggests that the specimens could contain infectious substances included in Category A or B. Professional judgment is required to determine whether there is no reason to believe a specimen contains an infectious substance. Factors such as the known medical history, symptoms and individual circumstances of the source, human or animal, and endemic local conditions should be considered. For more details regarding the classification of infectious substances contained in patient specimens, please consult the document on classification of patient specimens. Substances subject to the TDG RegulationsAny substance known or believed to contain infectious substances which meet the criteria of Category A or Category B is regulated under the TDG Regulations and must be assigned to UN2814, UN2900, UN3373, UN3291, or UN3549 as appropriate. A list of regulated infectious substances can be found in Appendix 3 of Part 2 of the TDG Regulations. Note that this list is not exhaustive, but it serves as guide to classify pathogens. Medical or Clinical WasteMedical or clinical wastes include sharps, soiled linen, etc. They are derived from the medical treatment of humans, the veterinary treatment of animals or from bio-research. They can be assigned to:
Note: UN3549 is a new classification. This classification is for solid medical waste containing Category A infectious substances generated from the medical treatment of humans or veterinary treatment of animals; it shall not be used for waste from bio-research or liquid waste. See Appendix for more information on transporting Ebola contaminated waste. Biological ProductsBiological products are derived from living organisms and are used to prevent, treat or diagnose disease in humans or animals. They are also used for development, experiment or investigation purposes and includes finished or unfinished products, live vaccines or attenuated live vaccines. A biological product known or reasonably believed to contain a pathogen that meets the definition of a Category A or B infectious substance must be assigned to UN2814, UN2900, or UN3373, as appropriate. Genetically Modified Microorganism and Organisms (GMMO and GMO)GMMOs and GMOs which do not meet the definition of infectious substances are not subject to the TDG Regulations, unless they meet the criteria for inclusion in another class. Patient SpecimensPatient specimens are those collected directly from humans or animals and include, for example, excreta, blood and its components, tissue and tissue fluids swabs, and body parts being transported for purposes such as research, diagnosis, investigational activities, disease treatment and prevention. Cultures versus patient specimensInfectious substances can be transported as cultures or contained in patient specimens. The risk of infection is higher in cultures, due to the high concentration of pathogens as opposed to patient specimens. Under certain conditions, infectious substances, classified as Category A, contained in patient specimens may be shipped as Category B. However, some infectious substances must always be shipped as Category A regardless of their form, due to their pathogenicity. Table 1 provides a list of 19 infectious substances that must always be shipped as Category A. See Subsection 2.36 (3). Table 2 - Infectious substances that are always shipped as Category A
Human or animal specimens are exempted from certain parts of the TDG Regulations if there is no reason to believe that the specimen contains an infectious substance. You can ship such specimens using the exemption under Section 1.42 of the TDG Regulations. If the specimens are part of routine screening tests, then they may be shipped as per Section 1.42 of the TDG Regulations if a professional judgment concludes there is no reason to believe the patient could be contaminated with an infectious substance. This is also true for samples collected for the purpose of testing for a known infectious substance. For example, an employer may wish to screen all new employees for infectious diseases. In this case, you may ship the sample as “Exempt Human Specimen” if the medical professional concludes there is no reason to believe that the person has been in contact with an infectious substance. Examples of specimens that may be transported under this section include:
Doctor-patient confidentialityThere are no exemptions that apply to shipping samples that are known or suspected to contain infectious substances. However, the TDG Regulations do not require you to include a patient’s name or any personal reference when shipping infectious substances. Shipping known or suspected infectious substances without complying with the TDG Regulations is an offence for which enforcement action is applicable. Assistance to classify infectious substancesTDG Directorate is the authority with regards to the classification of infectious substances for transportation. However, you could contact the Public Health Agency of Canada (PHAC) or the Canadian Food Inspection Agency of Canada for assistance in the classification of infectious substances. Public Health Agency of Canada Canadian Food Inspection Agency PackagingThe following types of packaging can be used to ship infectious substances:
A copy of the CAN/CGSB-43.125 Standard can be obtained from Public Service and Procurement Canada. Table 3 – Summary of the types of packaging
Type P620 packagingIt is defined as a packaging that is in compliance with the requirements of the CAN/CGSB-43.125 standard for Type P620 packaging or, if it is manufactured outside Canada, is in compliance with the requirements of Chapter 6.3 and Packing Instruction P620 of the UN Recommendations and the national regulations of the country of manufacture. This packaging is intended to transport an infectious substance of Category A in a form of culture or infectious substance of Category A meeting the requirements of Subsection 2.36 (3) of the TDG Regulations. However, as it is the highest integrity packaging, this packaging can also be used to transport Category B infectious substances and clinical, (bio) medical or regulated waste. You will find the requirements for the design, testing and marking of Type P620 packaging in Part I of the CAN/CGSB-43.125 standard. Facilities that manufacture type P620 packaging in Canada must be registered with Transport Canada and must have their packaging design registered with Transport Canada. The CAN/CGSB-43.125 standard now requires the periodic retest of a Type P620 packaging design every five years. Identify a Type P620 packagingA Type P620 packaging will have a UN marking on the outer packaging as set out in Section 5.1 of the CAN/CGSB-43.125 standard. For example: 4G/CLASS
6.2/21 Table 4 – Description of the UN packaging code and symbol
A Type P620 packaging shall consist of:
For liquid infectious substances, an absorbent material must be placed between the primary receptacle(s) and the secondary inner packaging and in sufficient quantity to absorb the entire content of the primary receptacle(s). The primary receptacle(s) of a type P620 packaging cannot be reused. The secondary inner packaging or outer packaging of a type P620 packaging may be reused if there is no visible contamination, damage or defects that may render the packaging unsafe for transport. Example of a Type P620 packagingFigure 1: Figure provided by IATA, Montreal, Canada (modified by the TDG Directorate) Figure 1 - Text versionType P620 packaging, which is a triple packaging system. The outer packaging is a UN specification box, with UN specification marking. The box is also marked with a Class 6.2 infectious substance label. Next to label is the shipping name "infectious substance affecting humans" and the UN number. There are also labels for the consignor (i.e. shipper) and consignee and a label for the responsible person that includes their telephone number. Finally, the outer packaging is labelled with an orientation label, which is two arrows pointing up. These arrows are only required for Air and Marine transport when the primary receptacle exceeds 50 ml or 50 g. Placed inside the outer package is a secondary packaging, which is leakproof. This secondary packaging is cylindrical in shape and has a screw-on cap. The secondary packaging is affixed with a label that includes an itemized list of its contents. Finally, inside the secondary packaging is the leakproof primary receptacle, which is a test tube. The test tube is surrounded by absorbent material. Type P650 packagingA Type P650 packaging is defined as a packaging that is in compliance with the requirements of the CAN/CGSB-43.125 standard for Type P650 packaging or, if it is manufactured outside Canada, is in compliance with the requirements of Packing Instruction P650 of the UN Recommendations and the national regulations of the country of manufacture. A Type P650 packaging is intended for the transport of UN3373 - Category B infectious substances. However, this packaging can also be used to transport clinical, (bio) medical or regulated waste UN3291. You will find the requirements for the design, testing and marking of Type P650 packaging in the CAN/CGSB-43.125 standard. Facilities that manufacture type P650 packaging in Canada are not required to be registered with Transport Canada, however, a Type P650 packaging design report must be prepared and retained by the manufacturer in accordance with Annex A of the Standard to demonstrate compliance with the Standard. Identify a Type P650 packagingThe marking required on the outer packaging of a Type P650 packaging is specified in Section 5.2 of the CAN/CGSB-43.125 standard. The Category B mark, as per Section 4.22.1, must be displayed on the outside of a Type P650 packaging to demonstrate compliance with the CAN/CGSB-43.125 Standard. The marking shall be in the form of a square on point with each side having a length of at least 50 mm. The width of the line shall be at least 2 mm and the letters and numbers shall be at least 6 mm high. The illustration below shows the marking for Type P650 packaging. Note: The marking required on a Type P650 packaging is a hybrid marking as it is used as the packaging compliance mark and the dangerous goods safety mark, (Category B Mark) found in the Appendix of Part 4 of the TDG Regulations. Therefore, having an empty packaging with this mark displayed on it could be considered misleading as it could indicate that a person is transporting UN3373, BIOLOGICAL SUBSTANCE, CATEGORY B. However, Special Provision 165 of the TDG Regulations allows the use of this mark even if the packaging is empty. A Type P650 packaging shall consist of:
Note: Either the secondary packaging(s) or the outer packaging shall be rigid. When transporting liquid infectious substances, absorbent material must be placed between the primary receptacle(s) and the secondary packaging in sufficient quantity to absorb the entire contents of the primary receptacle(s) so that any release of the liquid substance will not compromise the integrity of the cushioning material or of the outer packaging. When transporting solid infectious substances, if there is any doubt as to whether or not residual liquid may be present in the primary receptacle during transport then a packaging suitable for liquids, including absorbent materials, shall be used. The primary receptacle(s) of a type P650 packaging cannot be reused. The secondary inner packaging or outer packaging of a type P650 packaging may be reused if there is no visible contamination, damage or defects that may render the packaging unsafe for transport. Examples of a Type P650 packagingFigure 2: Figure provided by IATA, Montreal, Canada (modified by the TDG Directorate) Figure 2 - Text versionType P650 packaging. The outer packaging is a box that is labelled with the Category B mark, which is a square on point mark with "UN3373" written inside. Next to label is the shipping name "Biological Substances Category B". Also written on the box is the 24 hour telephone number. There are also labels for the consignor (i.e. shipper) and consignee. Placed inside the outer package is a secondary packaging, which is leakproof or siftproof. This secondary packaging is cylindrical in shape and has a screw-on cap. The secondary packaging is affixed with a label that includes an itemized list of its contents. Inside the secondary receptacle is a rack-type holder made from styrofoam or sponge. This rack is holding the primary receptacles, which are test tubes and surrounded by cushioning and absorbent material.
Types of standardized and non-standardized packagings to transport clinical, (bio) medical or regulated medical wasteThere are various options of standardized and non-standardized packagings permitted in Part III of the CAN/CGSB-43.125 standard for the transport of clinical, (bio) medical or regulated medical waste. The packaging options are dependent on the classification of the waste. The packaging options are summarized in the table below with a more comprehensive description following the summary table. Table 5 – Permitted packaging options for clinical, (bio) medical or regulated medical waste
Packagings permitted for clinical, (bio) medical or regulated medical waste assigned to UN2814 or UN2900A Type P620 packagingis permitted. Consult the Type P620 packaging section to learn more. Packagings permitted for clinical, (bio) medical or regulated medical waste assigned to UN32911. UN Standardized Small ContainerThe UN standardized small container must be a drum, jerrican, box, or composite packaging listed in Table 3 of the CAN/CGSB-43.125 standard and must meet a Packing Group I or II performance level. The packaging will bear a UN compliance marking. The packaging must be leakproof or be made leakproof by inserting a plastic bag in the packaging. The plastic bag must pass the Elmendorf tear strength and the Dart impact strength tests as specified in Table 6 of the CAN/CGSB-43.125 standard. 2. UN Standardized Intermediate Bulk Container (IBC)The UN standardized IBC must be listed in Table 4 of the CAN/CGSB-43.125 standard and must meet a Packing Group I or II performance level. The packaging will bear a UN compliance marking. 3. UN Standardized Large PackagingThe UN standardized large packaging must be listed in Table 5 of the CAN/CGSB-43.125 standard and must meet a Packing Group II performance level. The packaging will bear a UN compliance marking. 4. Non-Standardized Combination PackagingThis type of package consists of a securely closed plastic film bag placed inside either a:
There is no packaging compliance mark required on this packaging. Note: The plastic bag must pass the Elmendorf tear strength and the Dart impact strength tests as specified in Table 6 of the CAN/CGSB-43.125 standard. 5. A Type P620 PackagingConsult the Type P620 packaging section to learn more. 6. A Type P650 PackagingConsult the Type P650 packaging section to learn more 7. Packaging for Sharp Objects (i.e., sharps container)A packaging intended to contain sharp objects (for example, broken glass and needles) must meet the requirements of the CAN/CSA-Z316.6 standard or be rigid, leakproof, puncture resistant and designed for repeated use. Below is an image of a sharps container. Packagings permitted for solid medical waste assigned to UN3549The packaging is a triple layer packaging consisting of:
A fiberboard box meeting certain specifications may be used as an outer packaging in place of the UN packaging codes listed. The packaging requirements for transport of UN3549 were introduced into the 2021 edition of the CAN/CGSB-43.125 standard. A person transporting this waste must follow the packaging requirements prescribed within the Standard. To buy appropriate packagings for the transportation of infectious substances intended for disposal or wasteThe Transport Canada website has a list of vendors for Type P620 and P650 packaging. Transport Canada does not have a list of vendors for packagings permitted in Part III of the CAN/CGSB-43.125 standard because many different types of standardized and non-standardized packagings are permitted. You must ensure that your shipment meets the requirements listed in the standard for these types of packaging. To learn more about Type P620, Type P650 and packagings permitted for the transportation of clinical, (bio) medical or regulated waste, you can:
DocumentationShipping documentYou must prepare a shipping document if you are shipping a Category A infectious substance (UN2814 or UN2900). However, you will not need a shipping document if you are shipping a Category B infectious substance (UN3373) in accordance with the exemption set out in Section 1.39 of the TDG Regulations. Don’t forget that there are certain Category A infectious substances than can be shipped as a Category B. You need to refer to Subsections 2.36(2) and (3) of the TDG Regulations to verify which Category A infectious substances can be shipped as a Category B. To learn more, or to view a sample shipping document, consult the TDG Bulletin – Shipping Documents. Labels and placardsThe dangerous goods safety marks that must be displayed on a small means of containment depend on the type of infectious substance you are shipping.
Category AIf you are shipping a Category A, you must label the package with an infectious substance label. This label is illustrated in the Appendix to Part 4 of the TDG Regulations. Infectious substance label - Text versionClass 6.2, Infectious Substances label (square on point ). This label has the biohazard symbol at the top and the number 6 at the bottom. In the center of the label there is bilingual text that reads as follows: INFECTIOUS IN CASE OF DAMAGE OR LEAKAGE IMMEDIATELY NOTIFY LOCAL AUTHORITIES AND CANUTEC 613-996-6666 INFECTIEUX EN CAS DE DOMMAGE OU DE FUITE COMMUNIQUER IMMÉDIATEMENT AVEC LES AUTORITÉS LOCALES ET CANUTEC 613-996-6666 The text on the label is: INFECTIOUS INFECTIEUX CANUTEC Extra marking requirements: The shipping name and UN number:
(No technical name (SP16))
Category BWhen shipping a Category B infectious substance, Section 1.39 and Section 4.22.1 state that you must label the package with the "Category B mark" illustrated in the appendix to Part 4 of the TDG Regulations. Category B mark - Text versionCategory B Mark. Square on a point. White background with UN3373 in the centre. The text on the mark is: UN3373 Extra marking requirements: The shipping name:
Text on the package is:
Placards on the vehicleAs per Subsection 4.15(1) of the TDG Regulations, placards are required in the following instances: The infectious substances are transported in a large means of containment. By definition, a large means of containment is a means of containment with a capacity greater than 450 L (i.e., a delivery truck). However, Section 4.16.1 provides a placarding exemption for dangerous goods having a gross mass of 500 kg or less. Paragraph 7.2(1)(g) of the TDG Regulations refers to a list of 16 infectious substances that require an Emergency Response Assistance Plan (ERAP). For those situations, the placards and UN number must be displayed. The placarding exemption found in Section 4.16.1 cannot be used when an ERAP is required. The person who loads the vehicle or large means of containment is responsible for displaying the placards. This person could be either the consignor (i.e., shipper) or the carrier. Once the vehicle leaves the site, the carrier is responsible for placarding. Exemptions and special provisionsThere are two exemptions for shipping infectious substances or potential infectious substances. Like most exemptions, you can find them in Part 1 of the TDG Regulations.
In order to use an exemption, you must comply with all conditions listed in the exemption. If you can’t, then you need to ship your infectious substances fully regulated. Special provisions that only apply to infectious substancesSpecial Provision 84 states that infectious substances listed in Paragraph 7.2(1)(g) of the TDG Regulations require an emergency response assistance plan. Special Provision 128 exempts decontaminated medical or clinical waste that from all parts of the TDG Regulations (except Parts 1 and 2) under certain conditions. Special Provision 164 allows for the transport of other dangerous goods in the same small means of containment with UN2814, UN2900 or UN3373, if they are necessary for maintaining the viability or stability of the dangerous goods, for preventing their degradation or for neutralizing the hazards that they represent. Special Provision 165 of the TDG Regulations allows the use of the CATEGORY B mark even if the packaging is empty. Marine shipmentsWhen shipping by vessel, you must refer to Part 11 of the TDG Regulations. Air shipmentsWhen shipping by air, you must refer to Part 12 of the TDG Regulations. For liquid infectious substances transported by aircraft only, Type P650 packages must undergo the internal pressure test in accordance with Section 7.5 of the CAN/CGSB-43.125 standard. Domestic transportWhen transporting infectious substances domestically by air, Part 12 of the TDG Regulations requires you to comply with the ICAO Technical Instructions and Subsection 12.1(1) of the TDG Regulations. International transportWhen transporting infectious substances internationally by air (from or to Canada), Part 12 of the TDG Regulations requires you to comply with the ICAO Technical Instructions and Subsection 12.1(1) of the TDG Regulations. Quick reference guide – Road transport
Contact informationIf you have any questions about the TDG Regulations, contact a Transport Canada dangerous goods inspector in your region.
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Compliance with the Transportation of Dangerous Goods Act and RegulationsFailure to comply with the TDG Actand TDG Regulationsmay lead to fines and/or imprisonment. For more information, you can visit the TDG website. Appendix - Transporting Ebola contaminated wasteTransport Canada regulates the Ebola virus as an infectious substance under the TDG Regulations. Following the Ebola Outbreak of 2014-2016, a new UN number for solid infectious substance waste of Category A (UN 3549), as well as two associated packing instructions (P622 and LP622) were introduced into the 21st edition of the UN Model Regulations. Prior to this, there were no approved packagings suitable for transporting the large volumes of Category A waste that are generated from caring for a patient suspected or known to be contaminated with the Ebola virus. Transport Canada will be introducing the UN3549 classification into the TDG Regulations. The packaging requirements for UN3549 were introduced into the 2021 edition of the CAN/CGSB 43.125 standard. Anyone handling, offering for transport or transporting this infectious substance by road, rail, marine or air must comply with the TDG Regulations:
Note: The transport of deceased bodies contaminated with the Ebola virus is not regulated under the TDG Regulations. What label is used for infectious substance category A?Category A infectious substances have two shipping names: “Infectious substances, affecting humans” (UN 2814) or “Infectious substances, affecting animals” (UN 2900).
What is a Category A infectious agent?CATEGORY A: An infectious substance in a form capable of causing permanent disability or life- threatening or fatal disease in otherwise healthy humans or animals when exposure to it occurs.
Where should an itemized list of contents be placed in the packaging for a Category A substance?An itemized list of contents must be enclosed between the secondary packaging and the outer packaging, and the secondary package secured with cushioning material.
Does Category B requires a Class 6 infectious label on the box?If the culture being sent is not listed by IATA as a Category A infectious substance, then it can legally be sent as a “Biological Substance, Category B,” eliminating the need to prepare a Shipper's Declaration for Dangerous Goods or to use a UN-certified container with the Class 6 hazard label.
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