Shipping Infectious Substances
TABLE OF CONTENT
- Labels and Placards
- Marine Shipments
- Air Shipments
- Quick Reference Guide – Road Transport
- Contact Information
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.
What is an infectious substance?
An infectious substance is defined under Section 1.4 of the TDG Regulations. Basically, it’s a micro-organism that is known or reasonably believed to cause disease in humans or animals. The infectious substance might be contained in blood, tissue, organs, body fluids, vaccines or cultures.
As a consignor (i.e. shipper), what are my responsibilities?
As a consignor, you must comply with the requirements related to:
- Training (Part 6 – TDG Regulations);
- Classification (Part 2 – TDG Regulations);
- Emergency Response Assistance Plans (ERAP) (Part 7 – TDG Regulations);
- Packaging (Part 5 – TDG Regulations);
- Documentation (Part 3 – TDG Regulations);
- Labelling the package, and if applicable, placarding the vehicle (Part 4 – TDG Regulations);
- Reporting Requirements (Part 8 – TDG Regulations).
Do other government departments regulate infectious substances?
Yes. The Public Health Agency of Canada (PHAC) administers regulations that apply to laboratory safety and the importation of human pathogens in Canada. Provincial governments may have additional regulations that pertain to infectious substances, as well.
Learn more at: www.phac-aspc.gc.ca
Do I need TDG Training?
Always assume you need training. The only time training is NOT required is when you are using an exemption (i.e. special case) which exempts you from Part 6 or when the substance is believed not to be infectious. You will find most exemptions in Part 1 of the TDG Regulations from Sections 1.15 to 1.49.
Who issues the training certificate?
Employers are responsible for issuing a training certificate once their employee has received adequate training.
Is there a standard format for the training certificate?
No. However, the certificate must contain all of the information required by Section 6.3 of the TDG Regulations. Even though there is no standard format, we have a sample in our TDG Bulletin titled: “TDG Bulletin - TDG Training”.
How do I classify an infectious substance?
Infectious substances are classified as Class 6.2 (Infections Substances) dangerous goods. Class 6.2 has two categories: A or B. Category A is the most dangerous. You can only use four UN numbers for infectious substances.
- UN2814 – INFECTIOUS SUBSTANCE, AFFECTING HUMANS
- UN2900 – INFECTIOUS SUBSTANCE, AFFECTING ANIMALS only
- UN3373 – BIOLOGICAL SUBSTANCE, CATEGORY B
Medical or Clinical Waste
- UN2814 – INFECTIOUS SUBSTANCE, AFFECTING HUMANS, if they contain Category A infectious substances.
- UN2900 – INFECTIOUS SUBSTANCE, AFFECTING ANIMALS only, if they contain Category A infectious substances.
- UN3291– CLINICAL WASTE, UNSPECIFIED, N.O.S., (BIO) MEDICAL WASTE, N.O.S. or REGULATED MEDICAL WASTE, N.O.S., if the shipper has reasonable grounds to believe that they have a low probability of containing infectious substances.
Are all human or animal specimens regulated as infectious substances?
Human or animal specimens are exempted from certain parts of the TDG Regulations if you have 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.
Human or animal specimens are fully regulated if you have reason to believe that the specimen contains micro-organisms included in class 6.2. If this is the case, it should be classified as a Class 6.2 and assigned to Category A or B. Furthermore, even if a person has no previous history or symptoms of infection, a specimen should be classified as a Class 6.2 when you are shipping it for testing of a known and regulated infectious substance. This only applies when the medical professional has valid reasons for conducting the tests. For example, the patient may have been in contact with an infectious substance.
However, if the specimens are part of routine screening tests, then they may be shipped as per Section 1.42, even when testing for an infectious substance. For example, an employer may wish to screen all new employees for infectious substances. In this case, you may ship the sample as “Exempt Human Specimen” if the medical professional has no reason to believe that the person has been in contact with an infectious substance.
What is “reason to believe”?
The term “reason to believe” means that there is sufficient belief to suggest that the specimens contain infectious substances included in Category A or B.
Professional judgment is required to determine if a specimen is regulated. 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 example, organizations that transport blood bags and tubes from blood donor clinics to laboratories should not automatically have a “reason to believe” that the blood collected contains infectious substances.
I don’t want to violate doctor / patient confidentiality. Are there any exemptions that apply to shipping samples that I suspect or know contain infectious substances?
No. However, the TDG Regulations do not require you to include a patient’s name or any personal reference when shipping infectious substances.
If you ship a known or suspected infectious substance without the proper labelling or documentation, you could be fined up to $50,000 or sentenced to 2 years in prison.
Are sharps or infectious wastes regulated?
Yes. If the medical or clinical waste (sharps, soiled linen, etc.) contain Category A infectious substances, you must assign UN2814 or UN2900.
If the medical or clinical waste contain Category B infectious substances or if the shipper has reasonable grounds to believe that they have a low probability of containing infectious substances, you must assign UN3291.
Who can we contact if we need assistance for classifying infectious substances?
Contact the Public Health Agency of Canada – Office of Laboratory Security:
- Phone: 613-957-1779
- E-mail: PHAC.pathogens.pathogenes.ASPC@canada.ca
May I ever ship Category A infectious substances as Category B?
Subsection 2.36(2) of the TDG Regulations states that certain Category A infectious substances may be shipped as a Category B. This does NOT apply to Category A infectious substances that are in the form of a culture or any infectious substance listed under Subsection 2.36(3).
Below is a list of the 19 infectious substances that you MUST always ship as Category A.
|Name of Infectious Substance||UN Number|
What type of packaging may I use to ship infectious substances?
There are three types of packaging that you may use:
- Type 1A;
- Type 1B (must also comply with Section 5.16.1 of the TDG Regulations); or
- Type 1C.
Below is a table that summarizes when to use a given type of packaging.
Type of Packaging
||UN Number — Category|
What is a Type 1A packaging?
Type 1A packagings are required to be manufactured to the most stringent specifications and may be used for any infectious substances, even waste. You will find the requirements for the design, testing and marking of Type 1A containers in the CAN/CGSB-43.125 standard. Companies that manufacture type 1A packaging in Canada must have their design registered with Transport Canada.
Additional requirements are found in Section 18.104.22.168 of the standard when transporting infectious substances that are refrigerated, frozen, or in liquid nitrogen.
How do I identify a Type 1A packaging?
A Type 1A packaging will have UN marking on the outer packaging as set out in Section 4.9 of CAN/CGSB-43.125 standard. For example:
CAN / ABC 8-999
|Code or symbol||Description|
|United Nations packaging symbol.|
Packaging code (in this example, 4G represents a fiberboard box).
The “U” represents that the package was tested with fragile primary receptacles.
|CLASS 6.2||The text “CLASS 6.2” means that this type of container is suitable for Class 6.2 infectious substances.|
|11||The last two digits of the year of manufacture.|
|CAN||The country authorizing the allocation of the marking.|
|ABC 8-999||The name or symbol of the manufacturer and other identification of the container as specified by the country authorizing the allocation of the mark (e.g., design registration number).|
A Type 1A container is a triple packaging system consisting of:
- watertight primary receptacle(s);
- a watertight secondary packaging;
- absorbent material; and
- an outer packaging.
Type 1A packaging
Figure 1: Example of triple packaging system for the packaging and labelling of Category A infectious substances (Figure provided by IATA, Montreal, Canada)
What is a Type 1B packaging?
Type 1B packaging is typically used for UN3373 - Category B, but it can also be used for certain Category A infectious substances. However a Type 1B CANNOT be used for the infectious substances listed in "TABLE 1" of this document or in columns 3 or 4 of the table under Section 5.16. Category A infectious substances that are in the form of a culture cannot be transported in a Type 1B package. In these cases, a Type 1A must be used. You need to refer to Section 5.16 of the TDG Regulations for more details.
The performance requirements for Type 1B packaging are set out in Section 5.16.1 of the TDG Regulations. A Type 1B packaging must pass a 1.2 meter drop test. In addition, either the primary receptacle or secondary packaging must pass the 95 kPa pressure test.
There are construction requirements, but no performance requirements set out in CAN/CGSB-43.125 standard for Type 1B packaging.
How do I identify a Type 1B packaging?
The marking required on the outer packaging of a Type 1B container is specified in Section 5.3 of the CAN/CGSB-43.125 standard. The marking includes:
- the text “TC-125-1B”; and
- the name and address or symbol of the packaging manufacturer.
A Type 1B container is a triple packaging system consisting of:
- watertight primary receptacle(s);
- a watertight secondary packaging;
- absorbent material; and
- an outer packaging.
- Either the primary receptacle or secondary packaging must be capable of passing the 95 kPa pressure test when it contains a liquid.
- All components are tested together as a system.
Figure 2: Example of type 1B packaging (images provided by Saf-T-Pak)
Below is another example of a Type 1B packaging.
Figure 3: Example of type 1B packaging (Figure provided by IATA, Montreal, Canada)
Does a Type 1B packaging satisfy ICAO Packing Instruction 650 for air transport?
The International Civil Aviation Organization (ICAO) Technical Instructions refer to Packing Instruction (PI) 650 for transport of UN3373, BIOLOGICAL SUBSTANCE, CATEGORY B. A Type 1B packaging built to the CAN/CGSB-43.125 standard does not automatically satisfy all of the requirements specified in ICAO PI 650. If your shipment is subject to the requirements of PI 650 of the ICAO Technical Instructions, you must ensure that the additional requirements of PI 650 are complied with.
The following table outlines the significant differences between the requirements for a Type 1B packaging and a package prepared in accordance with ICAO PI 650. Please consult the ICAO Technical Instructions for details on PI 650.
CGSB-43.125 + 5.16.1
of the TDG Regulations
|Packing Instruction 650|
|Primary receptacle (inner) quantity limit||None||
1 L (liquid)
None for solids
|Outer package quantity limit||None||
4 L (liquid)
4 kg (solids)
|Outer packaging specifications||Must be resistant||
Must be rigid;
Must have minimum of size of 100 mm x 100 mm
|Safety marks||Diamond mark with UN3373 inside, Proper shipping name||Diamond mark with UN3373 inside, Proper shipping name|
|Design Tests||Drop test (1.2m), pressure capable receptacle to 95 kPa (for liquids only)||Drop test (1.2m), pressure capable receptacle to 95 kPa|
|Competent Authority Registration (i.e. TC Registration)||None||None|
|Refrigerated or Frozen Specimen||Must be in compliance with the requirements in Section 22.214.171.124 of CGSB-43.125||Specific requirements|
What is a Type 1C packaging?
Type 1C packaging is suitable for transporting most biomedical waste, that is, certain Category A and all Category B infectious substances intended for disposal.
What are the basic characteristics of a Type 1C packaging?
A Type 1C packaging may be either a single or a combination packaging. Below is a summary for clause 6 of the CAN/CGSB-43.125 standard. There are 3 options:
1. SINGLE PACKAGING (e.g., Intermediate Bulk Container (IBC) or Drum)
A single Type 1C package may consist of some type of UN standardized packaging tested to Packing Group I or II performance level. A UN standardized packaging could be either an intermediate bulk container (IBC) or a drum (plastic, steel and fibreboard).
2. COMBINATION PACKAGE (e.g., Bag placed inside a box, inside an IBC or inside a drum)
A combination Type 1C package may consist of a:
securely closed plastic film bag placed inside either a:
- Packaging that is rigid, leak-proof and designed for repeated use; or
- Inside a fibreboard box, drum or IBC manufactured according to the UN Recommendations. It could also be a non-standardized packaging that complies with the criteria listed in CAN/CGSB-43.125.
3. SHARPS CONTAINER
A sharps container must:
- meet the requirements of standard CAN/CSA-Z316.6-95; or
- be rigid, leak proof and designed for repeated use.
How do I identify a Type 1C container?
There is no certification markings required for a Type 1C container. A Type 1C container will not have a UN marking if it is a non-standardized means of containment. However, if a component of a Type 1C container is a UN standardized means of containment (for example, a UN Drum or UN intermediate Bulk Container) that component will have a UN marking.
CAN / ABC 2-001
What does a Type 1C packaging look like?
As mentioned above, a Type 1C package can be many different things, such as a box, drum, a bag placed inside a box or a sharps container. Below is an image of a sharps container.
Where can I buy Type 1A, 1B and 1C packaging?
The Transport Canada website has a list of vendors for Type 1A and 1B packaging.
Transport Canada does not have a list of vendors for Type 1C packaging since the CAN/CGSB-43.125 standard allows for many different types of non-specification packaging. You must ensure that your shipment meets the requirements listed in the standard for Type 1C packaging.
How do I learn more about infectious substance packaging?
To learn more about Type 1A, Type 1B and Type 1C packaging, you can:
- Read our FAQs on our website; or
- Email one of our engineers at: firstname.lastname@example.org.
Do I need a shipping document?
You 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 what Category A infectious substances can be shipped as a Category B
Do I need to list the biological/technical name of the infectious substance on the shipping document?
Where can we get more information on shipping documents?
To learn more, or to view a sample shipping document, consult our TDG Bulletin titled: “TDG Bulletin - Shipping Documents”.
Labels and Placards
Which dangerous goods safety marks must we display on a small means of containment?
That depends on the type of infectious substance you are shipping.
|CATEGORY A||CATEGORY B|
If 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.
The text on the label is:
INFECTIOUS IN CASE OF DAMAGE OR LEAKAGE IMMEDIATELY NOTIFY LOCAL AUTHORITIES AND
INFECTIOUS INFECTIEUX EN CAS DE DOMMAGE OU DE FUITE COMMUNIQUER IMMEDIATEMENT AVEC LES AUTORITÉS ET
Extra marking requirements:
The shipping name and UN number:
(No technical name (SP16))
The text on the mark is:
Text on the package is:
24-Hour Number: 999-999-9999
Extra marking requirements:
The shipping name
Does the vehicle need placards?
As per Subsection 4.15(1) of the TDG Regulations, placards are required when:
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 (for example, a delivery truck). However, Section 4.16.1 provides a placarding exemption for dangerous goods having a gross mass of 500 kg or less.
Subsection 7.1(7) of the TDG Regulations lists 16 infectious substances that require an 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.
Who is responsible for placarding the vehicle?
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.
Are there any exemptions?
There 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.
- Section 1.39 – Class 6.2, Infectious Substances, UN3373, BIOLOGICAL SUBSTANCE, CATEGORY B exemption.
- Section 1.42.3 – Medical or Clinical Waste.
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.
Is there anything I should know for marine shipments?
When shipping by vessel, you must refer to Part 11 of the TDG Regulations.
When transporting infectious substances domestically by vessel, Part 11 of the TDG Regulations requires you to comply with the TDG Regulations only. In this case, you are not required to use the International Maritime Dangerous Goods Code (IMDG Code).
When transporting infectious substances internationally by vessel or by vessel on a "home-trade voyage, class 1", Part 11 of the TDG Regulations requires you to comply with the IMDG Code and some additional requirements in the TDG Regulations.
Is there anything I should know for air shipments?
When shipping by air, you must refer to Part 12 of the TDG Regulations.
However, there is an exemption under Section 12.6 of the TDG Regulations that applies to air operators. It relates to the handling and transporting of toxic and infectious substances.
When transporting infectious substances internationally 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.
Quick Reference Guide – Road Transport
|Item||Category A||Category B||Waste|
Infectious Substance, Affecting Humans
Infectious Substance, Affecting Animals
Biological Substance, Category B
UN2814 or UN2900 if
waste contains Category A
UN3291 if waste contains Category B or if the shipper has reasonable grounds to believe that there is a low probability of containing infectious substances
Type 1B (Only in certain instances. Refer to Section 5.16 and Subsections 2.36(2) and (3) of the TDG Regulations for more details)
||No, if shipped in accordance with Section 1.39 of the TDG Regulations||No, if shipped in accordance with Section 1.39 or Section 1.42.3 of the TDG Regulations|
Yes, Class 6.2 label
Shipping name and UN number (no technical name)
Category B mark and 24-hour number
Not required if
shipped in accordance with Section 1.42.3 of the TDG Regulations
Yes, if ERAP is required; see Section 7.1(7)
No, if total gross mass of shipment is 500 kg or less and no ERAP is required
|No, if total gross mass of shipment is 500 kg or less||No, if total gross mass of shipment is 500 kg or less|
Not required if
shipped in accordance with Section 1.42.3 of the TDG Regulations
Compliance with the Transportation of Dangerous Goods Act and Regulations
Failure to comply with the TDG Act and TDG Regulations may lead to fines and/or imprisonment. For more information, you can visit the TDG website at: www.tc.gc.ca/tdg. If you have any questions about the TDG Regulations, contact a Transport Canada dangerous goods inspector in your region.
|Quebec Region||(514) 283-5722||TMD-TDG.Quebec@tc.gc.ca|
|Ontario Region||(416) 973-1868||TDG-TMDOntario@tc.gc.ca|
|Prairie & Northern Region||1-888-463-0521||TDG-TMDPNR@tc.gc.ca|
|Pacific Region||(604) 666-2955||TDGPacific-TMDPacifique@tc.gc.ca|
Purchase of Standards and Publications
- Canadian General Standards Board (CGSB) – Packaging standard
- International Civil Aviation Organization (ICAO) – Air
- International Maritime Dangerous Goods Code (IMDG Code) – Ship / Vessel
Transporting Ebola Contaminated Waste
Transport Canada regulates the Ebola virus as an infectious substance under the TDG Regulations. Anyone handling, offering for transport or transporting this infectious substance by road, rail, marine or air must comply with the TDG Regulations:
- Part 3 requires the consignment to be accompanied by a shipping document.
- Part 4 requires the means of containment to display the appropriate safety marks.
Section 5.16 requires the use of a Type 1A package. However, with the recent Ebola outbreak, we have realized that these packages are not large enough for items such as personal protective equipment, gowns, gloves, linen, waste, etc.
As such, a person may apply for an Equivalency Certificate in order to transport Ebola contaminated waste in a means of containment, other than a type 1A, that provides an equivalent level of safety. The person must provide the required information listed in Section 14.1 of the TDG Regulations and include a detailed description of the packaging he/she proposes to use.
Send your questions pertaining to an Equivalency Certificate to email@example.com or call 1-855-298-1520.
You may apply:
Chief, Permits and Approvals Division
Transportation of dangerous goods Directorate
330 Sparks Street, 9th Floor
Ottawa ON K1A 0N5
- Part 6 requires anyone who handles, offers for transport or transports the infectious substances to be properly trained and hold a training certificate.
Part 7 requires anyone who offers for transport or imports any quantity of the Class 6.2 infectious substances listed in Subsection 7.1(7) to have an approved Emergency Response Assistance Plan (ERAP). The Ebola virus is listed in Paragraph 7.1(7)(b).
- It is the person who offers for transport or imports Ebola contaminated waste who must apply for an ERAP.
- Transport Canada will issue a reference number in writing when it approves the ERAP.
- The ERAP reference number and activation telephone number must appear on the shipping document.
- A person may request written permission to use another person’s approved ERAP if it applies to the dangerous goods, the mode of transport, the means of containment and the geographical area. The person who holds the approved ERAP must also agree to respond to an emergency on behalf of the other person.
- To learn more about ERAPs, visit: Emergency Response Assistance Plans (ERAPs).
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