Shipping Biological Substances at the U of R

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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.
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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
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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)
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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.
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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
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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
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
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
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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
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



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.
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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.
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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)
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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)
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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.
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