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Transportation of Dangerous

Goods (TDG) Guide to

Shipping Biologicals

2018

Safety Resources

i

Contents

1 Overview ............................................................................................................................. 1

2 Definitions ........................................................................................................................... 1

3 Classification ....................................................................................................................... 2

4 Packaging Biological or Infectious Samples ........................................................................ 4

4.1 Packaging for Exempt Patient Specimens ................................................................... 5

4.2 Packaging Category B Infectious Substances .............................................................. 6

4.3 Packaging Category A Infectious Substances .............................................................10

4.4 Packaging of Class 6.2 with Dry Ice ............................................................................13

5 References ........................................................................................................................16

TDG Guide for Shipping Biologicals February 2018

Safety Resources Page 1 of 16

1 Overview

This guide is a support document to help individuals who hold a valid Transportation of Dangerous Goods

(TDG) certificate to ship biological and/or infectious substances in accordance to the TDG regulations. This

guide contains excerpts from the International Air Transport Association (IATA) 59th Edition 2018.

2 Definitions

a. Biological Substances: Products derived from living organisms which are manufactured and distributed in accordance with the requirements of appropriate national authorities, which may have special licensing requirements, and are used either for prevention, treatment, or diagnosis of disease in humans or animals, or for development, experimental or investigational purposes related thereto. They include, but are not limited to, finished or unfinished products such as vaccines.

b. Category A: 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. Infectious substances are listed on the Indicative List of Category A Infectious Substances (refer to Table 1).

c. Category B: Infectious substances which contain, or suspected to contain pathogens and are not found on the Indicative List of Category A Infectious Substances (refer to Table 1).

d. Class 6.2: A material known or reasonably expected to contain a pathogen, such as bacteria, viruses, parasites, fungi or prions that can cause disease in humans or animals.

e. Classification: The process of establishing whether a material is a dangerous good, and to which Class, or Division, of dangerous goods it should be assigned.

f. Infectious Substances: Substances which are known or are reasonably expected to contain pathogens.

g. Pathogens: Micro-organisms (including bacteria, viruses, rickettsiae, parasites, fungi) and other agents such as prions, which can cause disease in humans or animals. Toxins from plant, animal or bacterial sources which do not contain any infectious substances or toxins that are not contained in substances which are infectious substances should be considered for classification in Division 6.1 and assigned to UN3172.

h. Patient specimens: Human or animal materials collected directly from human or animals and transported for research, diagnosis, investigational activities, or disease treatment or prevention. Patient specimens include excreta, secreta, blood and its components, tissues and tissue swabs, body parts, and specimens in transport.

i. Shipper’s Declaration Form of Dangerous Goods: An IATA term used to describe the approved format for legal shipping or transport document. It conveys all necessary information pertaining to a dangerous goods shipment.



3 Classification

The classification of the biological substance will determine how the samples are packaged for transport. Infectious substances found in Class 6.2 and are divided into the following categories:

Patient specimens; Category B; or Category A.

Refer to the flowchart in Figure 1 below to which category the biological or infectious material fall under. Once the classification has been determined, follow the packing instructions for that specific description. Figure 1: Classification Flowchart for Class 6.2

To determine if an infectious substance is a Category A, refer to Table 1 for the Indicative List of Category A Infectious Substances to determine if the infectious substance is on the list.



Table 1: Indicative List of Category A Infectious Substances UN Number

and Proper

Shipping

Name

Microorganisms Classified as

CATEGORY A in ANY form

(ALWAYS classified as Category A)

Microorganisms Classified as

Category A only when CULTURED

UN 2814,

Infectious

substances,

affecting

humans

Crimean-Congo hemorrhagic fever virus

Ebola virus

Flexal virus

Guanarito virus

Hantaan virus

Hantavirus causing hemorrhagic fever with renal

syndrome

Hantavirus causing pulmonary syndrome

Hendra virus

Herpes B virus (Cercopithecine herpesvirus-1)

Junin virus

Kyasanur Forest disease virus

Lassa virus

Machupo virus

Marburg virus

Monkeypox virus

Nipah virus

Omsk hemorrhagic fever virus

Russian spring-summer encephalitis virus

Sabia virus

Variola virus

Bacillus anthracis

Brucella abortus

Brucella melitensis

Brucella suis

Burkholderia mallei (Pseudomonas mallei –

Glanders)

Burkholderia pseudomallei (Pseudomonas

pseudomallei)

Chlamydia psittaci – avian strains

Clostridium botulinum

Coccidoides immitis

Coxiella burnetii

Dengue virus

Eastern equine encephalitis virus

Escherichia coli, verotoxigenic

Francisella tularensis

Hepatitis B virus

Herpes B virus

Herpesvirus simlae

Human immunodeficiency virus

Human coronavirus – Severe acute respiratory

syndrome (SARS)

Highly pathogenic avian influenza virus

Japanese Encephalitis virus

Mycobacterium tuberculosis

Monkey B virus

Poliovirus

Rabies virus

Rikettsia prowazaekii

Rikettsiae rickettsia

Rift Valley fever virus

Russian spring summer encephalitits virus

Shigella dysenteriae type 1

Tick borne encephalitis virus

Venezuelan equine encephalitits virus

West Nile virus

Yellow Fever virus

Yersinia pestis

UN 2900,

Infectious

Substances,

affecting

animals

Note:

The list of indicative examples of Category A

Infectious Substances is not exhaustive as there may

be new or emerging pathogens.

If a pathogen has the ability to cause permanent

disability, or a life threatening or fatal disease in

otherwise healthy humans or animals, it must be

classified as a Category A Infectious substance.

African swine fever

Avian paramyxovirus Type 1-Velogenic

Newcastle disease virus

Classical swine fever virus

Foot and mouth disease virus

Goatpox virus

Hog Cholera virus – Classical swine fever

Lumpy skin disease virus

Mycoplasma mycoides (Contagious bovine

pleuropneumonia)

Peste de petits ruminants virus

Rinderpest virus

Sheep-pox virus

Swine vesicular disease virus

Vesicular stomatitis virus



Note: Infectious substances meeting Category A criteria which cause disease in humans or both in humans and animals must be assigned to UN 2814. Infectious substances which cause disease only in animals must be assigned to UN 2900.

Infectious substances not listed in Table 1 are categorized as Category B. Non-infectious biological substances are categorized as Exempt Patient Specimens (animal or

human), or the biological substances are not regulated. If the biological or infectious substance contains a dangerous goods, such as a preservative,

additional TDG requirements may be needed. Consult with Safety Resources for assistance. Refer to Table 2, for the classification summary of Class 6.2 Infectious Substances. Table 2: Classification Summary for Class 6.2 Infectious Agents

4 Packaging Biological or Infectious Samples

Biological or infectious substances must be packaged in accordance to TDG regulations, which minimizes

the risk of exposure to the shipper, carrier, receiver, public, and the environment. All biological or

infectious substances must be packaged using the “triple packaging process”. This process consists of

packaging the biological or infectious substance into three layers as follows:

Primary Receptacle: Biological or infectious substance placed into a primary receptacle

(appropriately labelled), which is watertight, leak-proof and Ensure its lid is secured.

Absorbent Material: The primary receptacle is packaged with enough absorbent material to

absorb all fluid in case of breakage.

Secondary Receptacle: The primary receptacle with absorbent material is then placed into a

secondary receptacle, which is durable, watertight, leak-proof to enclose and protect the primary



receptacle. 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.

Outer packaging: The secondary receptacle is then placed into a fibreboard box or Styrofoam

container inside a shipping box (adequate strength for its capacity, mass and intended use, and

with at least one surface having minimum dimensions of 100 mm × 100 mm).

Refer to Figure 2 for illustration of the “triple packaging process”

Figure 2: Triple Packaging Process

4.1 Packaging for Exempt Patient Specimens

Exempt patient specimens (human or animal) are not TDG regulated (not assigned proper shipping name or UN number, however, they must be packaged with the “triple packaging process” (refer to Figure 2). Other requirements includes:

The outer packaging must be marked "Exempt human specimen" or "Exempt animal specimen", as appropriate.

At least one surface of the outer packaging must have a minimum dimension of 100 mm x 100 mm.

For documentation, a waybill would be required for air transport. An import permit may be required from the country that the package is being shipped to. Consult with the Biosafety Group from Safety Resources.

Refer to Figure 3 for an example of the marking and labelling of exempt patients specimen (human or animal).

Primary Receptacle with

absorbent material

Secondary Receptacle

Outer Packaging



If other dangerous goods are present with patient specimens the relevant provisions of the Dangerous Goods Regulations (DGR) apply to those goods. Consult with the Biosafety group from Safety Resources. When dangerous goods intended for air transport are carried by surface transport to or from an airport, any other applicable national or modal transport requirements should be met in addition to those that are applicable for the goods when carried by air.

Figure 3: Example of Packing, Labelling, and Marking for Exempt Specimens

4.2 Packaging Category B Infectious Substances

Category B infectious substances are TDG regulated and are assigned the following UN number and proper shipping name: UN 3373, Infectious substance, Category B.

Category B infectious substances are packaged in accordance to Packing Instruction 650, which is based on the “triple packaging process”.

Shipper: Chemifax Ltd.

19 Roy Rd., Ottawa, ON

K1A 0A9

(613) 525-8888

Consignee: Dwayne Smith

UBC, 52 Campus Dr.

Vancouver, BC V6T 2A3

Shipper and Consignee

Contact information

Exempt Patient

Specimen label

(human or animal)

X

Orientation labels

http://images.google.ca/imgres?imgurl=http://www.casa.gov.au/dg/images/wayup.gif&imgrefurl=http://www.casa.gov.au/dg/freight/labels.htm&h=108&w=80&sz=2&hl=en&start=42&tbnid=2Ux75XDXcOWhmM:&tbnh=85&tbnw=63&prev=/images?q%3Dthis%2Bway%2Bup%2Btransportation%2Bof%2Bdangerous%2Bgoods%26start%3D40%26gbv%3D2%26ndsp%3D20%26svnum%3D10%26hl%3Den%26sa%3DN

http://images.google.ca/imgres?imgurl=http://www.casa.gov.au/dg/images/wayup.gif&imgrefurl=http://www.casa.gov.au/dg/freight/labels.htm&h=108&w=80&sz=2&hl=en&start=42&tbnid=2Ux75XDXcOWhmM:&tbnh=85&tbnw=63&prev=/images?q%3Dthis%2Bway%2Bup%2Btransportation%2Bof%2Bdangerous%2Bgoods%26start%3D40%26gbv%3D2%26ndsp%3D20%26svnum%3D10%26hl%3Den%26sa%3DN



Packing Instruction 650 requires the following:

Use “triple packaging process” (refer to Figure 2), with the following additional requirements:

For liquid samples, primary receptacle must be secured with positive means, such as parafilm wax or tape.

Primary or secondary receptacles must be able to withstand an internal pressure of 95 kPa and a temperature range of -40°C to +55°C without leakage.

The primary receptacle(s) must not contain more than 1 L and the package must not contain more than 4 L.

Packaging must be good quality, strong enough to withstand vibrations and loadings encountered during transport.

Outer packaging must be rigid and does not need to be UN rated,

For road transport, the outer package must be must be TC125-1B rated.

Packaging must be constructed and closed to prevent any loss of contents that might be caused under normal transport conditions.

At least one surface of the outer packaging must have a minimum dimension of 100 mm x 100 mm.

An itemized list of contents must be placed between the secondary and outer packaging.

The secondary packaging must be placed securely, with suitable cushioning, inside the outer packaging.

Requires the name and telephone number of who is responsible for the package and the 24 hour emergency response phone number, such as CANUTEC (1-613-996-6666) on the outer box.

Does not require a Shippers Declaration of Dangerous Goods forms for air transport, but it will require an air waybill.

Package requires a U of S Biological Declaration Form, and/or an import permit from the country that the package is being shipped to. Consult with the Biosafety group from Safety Resources.

If other dangerous goods are present with Category B infectious substance, the relevant provisions of the DGR apply to those goods. A quantity of 30 mL or less of dangerous goods included in Classes 3, 8 or 9 may be packed in each primary receptacle containing infectious substances. When these small quantities of dangerous goods are packed with infectious substances in accordance with this packing instruction, no other requirements in these regulations need be met.

Refer to Figure 4 for an example of the marking and labelling of Category B infectious substances.



Figure 4: Example of Packing, Labelling and Marking of Category B Infectious Substance

For Air Transport:



For Road Transport:

For Road

(TC-125-1B)



4.3 Packaging Category A Infectious Substances

Category A infectious substances are TDG regulated and are assigned the following UN numbers and proper shipping names:

UN 2814, Infectious substance, affecting humans; and

UN 2900, Infectious substance, affecting animals.

Category A infectious substances are packaged in accordance to the following instructions:

Packing Instruction 620, which is based on the “triple packaging process”; and

Special provisions A81 and A140.

Packing Instruction 620 requires the following:

Use “triple packaging process” as described for Packing Instructions 650 (used for Category B), with the following additional requirements:

The packaging material must be in good condition; and tested to meet UN specifications, which is tested by the manufacturer of the packaging materials. The outer packaging must have the following UN specification labeling:

Shippers Declaration of Dangerous Goods form is required for air transport, in addition to an air waybill.

Package requires a U of S Biological Declaration Form, and/or an import permit from the country that the package is being shipped to. Consult with the Biosafety group from Safety Resources.

In addition to Packing Instructions 620, the special provisions for Category A infectious substances must be followed, which include:

A81: Stipulates the maximum quantity limit of up to 50 ml or 50 g for passenger and cargo aircrafts, and 4L or 4 kg for cargo aircrafts only; and

A140: Requires the proper shipping name must be supplemented with the technical, or scientific name on the Shipper’s Declaration of Dangerous Goods form only.

If other dangerous goods are present with Category A infectious substance, the relevant provisions of the DGR apply to those goods. A quantity of 30 mL or less of dangerous goods included in Classes 3, 8 or 9 may be packed in each primary receptacle containing infectious substances. When these small quantities of dangerous goods are packed with infectious substances in accordance with this packing instruction, no other requirements in these regulations need be met.

4G/Class 6.2/13 CAN/SAF-T-PAK 8-39



Refer to Figure 5 for an example of the marking and labelling of Category A infectious substances.

Figure 5: Example of Packing, Labelling and Marking of Category A Infectious Substance

For a summary checklist of the packing requirements for Class 6.2, refer to Figure 6.



Figure 6: Summary Checklist for Class 6.2 Infectious Substances



4.4 Packaging of Class 6.2 with Dry Ice

Infectious substances can be shipped with dry ice, or solid carbon dioxide. Dry ice is TDG regulated and is assigned the following UN number and proper shipping name: UN 1845, Dry Ice.

When shipping with dry ice, the Class 6.2 infectious substances are packed in accordance to the specific packaging requirements as previously described. When packaging dry ice with the Class 6.2 infectious substance, Package Instructions 954 must be followed.

Packing Instruction 954 refers to the following:

Dry ice must never be placed in a sealed container, for example a Styrofoam container with a lid taped shut, as there is a risk of explosion.

Use packaging designed and constructed to ship dry ice, which allows carbon dioxide to escape.

Use packaging that is designed to secondary packaging in the original position to prevent the secondary container from shifting inside the outer packaging in absence of the dry ice.

The quantity limit for dry ice on a personal and cargo aircraft cannot exceed 200 kg.

If using a Styrofoam container, ensure that the outer packaging is a fibreboard box. Refer to Figure 7 below.

Figure 7: Example of Packaging Biological Substance on Dry

Refer to Figure 8 for an example of the marking and labelling of Category B Class 6.2 infectious substances with dry ice.

Insulated Cover

Dry Ice

Sample tubes packed in 2°

container with absorbent material

Dry Ice

Styrofoam Container

Heavy gauge fibreboard box

Proper labelling for shipments

containing Dry Ice



Figure 8: Example of Packing, Labelling and Marking of Class 6.2 Infectious Substance with Dry Ice

Exempt Patient Specimens

Category B, Infectious Substance



Category A, Infectious Substance

Shippers Declaration of Dangerous Goods form for dry ice is not required for air transport. It is only

required for Category A infectious agents, in addition to an air waybill.

The Package requires a U of S Biological Declaration Form, and/or an import permit from the package is being shipped to. Consult with the Biosafety group from Safety Resources.



5 References

IATA Dangerous Goods Regulations, 58th Ed., 2017

o Class 6.2 – Infectious Substances https://www.iata.org/whatwedo/cargo/dgr/Documents/infectious-substance-classification-DGR56-en.pdf

o Packing Instruction 650 https://www.iata.org/whatwedo/cargo/dgr/Documents/packing-instruction-650-DGR56-en.pdf

Transportation of Dangerous Goods, TDG Bulletin Shipping Infectious Substances, Transport Canada, September 2016.

https://www.tc.gc.ca/media/documents/tdg-eng/Shipping_Infectious_Substances_NEW.pdf World Health Organization, Guidance on regulations for the Transport of Infectious Substances

2017-2018, January 2017. http://www.who.int/ihr/publications/WHO-WHE-CPI-2017.8/en/ SafTPaK, Compliance Training Reference Manual for the Safe Transport of Division 6.2 Infectious

Substances, Biological Specimens, Dry Ice, and Related Materials, 2017.

https://www.iata.org/whatwedo/cargo/dgr/Documents/infectious-substance-classification-DGR56-en.pdf

https://www.iata.org/whatwedo/cargo/dgr/Documents/infectious-substance-classification-DGR56-en.pdf

https://www.iata.org/whatwedo/cargo/dgr/Documents/packing-instruction-650-DGR56-en.pdf

https://www.iata.org/whatwedo/cargo/dgr/Documents/packing-instruction-650-DGR56-en.pdf

https://www.tc.gc.ca/media/documents/tdg-eng/Shipping_Infectious_Substances_NEW.pdf

http://www.who.int/ihr/publications/WHO-WHE-CPI-2017.8/en/