ONLINE SELF-STUDY
Shipping of Infectious Substances and Other
Biomedical Materials Annual Update
Regulatory Updates

June 2014 Changes:
•
•
New small quantities exception-De Minimis Quantities
Changes to Dry Ice label
Course Objectives
The purpose of this program is to:

ensure the safe handling of hazardous materials using good sensible practices.

recognize hazardous materials and realize there are special requirements

comply with Federal and International regulations
The basic goal for this training is to provide a framework for decisions

Is material to be shipped a dangerous good, genetically modified, biological
substance category B, or an exempt human specimen?
Upon completion you will receive certification to ship hazardous materials
Course Objectives
This training will increase your awareness of safety and compliance issues. If you need more information or help
with shipping your package you can e-mail the EHS Shipping Specialist. The training will cover the topics
listed below. Classification, identification, and packaging are three of the most important topics covered.

Regulatory Oversight

Dangerous Goods/Hazardous Materials

Training Requirements

Shipper’s & Operators’ Responsibilities

Classification, Identification

Packaging

Shipping with dry ice and Overpacks

Marking & labeling packages

Shipping documentation

Emergency Response

Laboratory Security

Accept or reject shipments by use of checklist
Regulatory Oversight
Federal Regulations:
U.S. Dept. of Transportation (DOT) – 49 CFR
Other federal requirements: CDC, OSHA, USDA, Department of Commerce, International Traffic and Arms
(ITAR) and Toxic Substance Control Act (TSCA)
DOT regulations primarily cover ground transportation. DOT is the organization that has the authority to fine you
for violations. Their authority extends well beyond US boundaries. Import permits from the CDC or USDA
may be needed if you are importing human etiological organisms or plant or animal pathogens.
Department of Commerce licenses may be needed to export organisms, genetic elements, chemicals,
technology or other commodities. TSCA Certification may be needed to import or export certain chemicals.
International Regulations (Air shipments)
International Civil Aviation Organization (ICAO)
International Air Transport Association (IATA)
Dangerous Goods Regulations (DGR)
Internationally, the UN Committee of Experts (CoE) develops recommended procedures for the transport of all
types of dangerous good except Radioactive material. The International Civil Aviation Organization (ICAO)
uses the UN recommendations as the basis for developing the regulations for the safe transport of
dangerous goods by air. IATA is the international trade organization that interprets ICAO regulations and
provides the Dangerous Goods Regulations (DGR). The IATA regulations are more stringent than DOT. This
training program follows the IATA regulations. IATA regulations are minimal requirements - your carrier can
be more stringent.
Regulatory Oversight
Fines and Penalties
"Violations contrary to the U.S. Code of Federal Regulations
(CFR) 49, if substantiated, may result in the assessment of a
civil penalty of up to $37,500 per violation, and deliberate
violations may result in criminal prosecution of up to
$500,000 and 5 years in prison."

There has been an increase in the number of Federal
Aviation Inspections (FAA) in response to the 1996 ValuJet
crash, the September 11, 2001 attacks, and the UPS
package bomb scare in November 2010.

If you are receiving a HazMat package it is your
responsibility to ensure the sender packages it correctly.
Oxygen-generating canister like the ones on board the
ValuJet flight 592
Definitions
Infectious Substance - Class 6.2 Definition:
Infectious substances are substances known to contain, or reasonably expected to
contain, pathogens.
Pathogens are defined as micro-organisms (including bacteria, viruses, rickettsia,
parasites, fungi) and other agents such as prions which can cause disease in humans
or animals.
Critical to the infectious substance definition is the ability to cause disease.
Note the reliance on your professional judgment when the words “reasonably
expected” are used.
Definitions
The IATA definition for infectious substances leaves out toxins. Toxins are placed in a
separate category. They are treated like chemicals.
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 assignment to
UN 3172 (for liquids) or UN 3462 (for solids).
Contact EHS if you are shipping toxins as instructions for shipping toxins is not covered
in this training module. Please be aware that many toxins (if shipped out of the US)
are regulated by the Department of Commerce. There are significant fines
associated with exporting toxins without a license
Definitions
Biological products
Those 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.
Patient Specimens
Patient Specimens are human or animal materials, collected directly from humans or animals,
including, but not limited to, excreta, secreta, blood and its components, tissue and tissue fluid
swabs, and body parts being transported for purposes such as research, diagnosis,
investigational activities, disease treatment and prevention.
Cultures
Laboratory stocks are the result of a process by which pathogens are intentionally propagated in
order to generate high concentrations. This increases the risk of infection when exposure to
them occurs. An example of this would be a patient sample of TB that has been cultured.
Training Requirements
You must be currently certified to legally ship dangerous
goods.
Who needs to be certified?
 Anyone who
–
–
–
–
–

prepares,
classifies,
packs,
labels,
or offers a dangerous good for transport.
Certification is valid for 2 years. Completing this training
one time is not enough. It must be renewed every 2 years to
maintain shipping certification.
Classification and Identification of
Dangerous Goods
What is a dangerous good?



Any material that the Secretary of Transportation
determines poses a risk to health, safety, property,
or the environment.
A dangerous good is any article or substance
capable of posing a risk to health, safety, property,
or the environment (IATA).
A material or substance posing an unreasonable risk
to health, safety, and property when transported
(DOT).
Classification of Infectious
Substances
Infectious substances are divided into the following categories,
Category A and Category B. The following are the proper
shipping names for each category:
Category A
 Infectious substances, affecting humans, UN 2814
 Infectious substances affecting animals, UN 2900
Category B
 Biological Substances Category B, UN 3373
Classification
Category A Infectious Substances - an infectious substance which is transported in a
form that when exposure occurs, is capable of causing permanent disability, life
threatening or fatal disease in otherwise healthy humans or animals. Examples of
substances that meet this criteria are located in this table: Table 3.6.D.
NOTE: An exposure occurs when an infectious substance is released outside of the
protective packaging, resulting in physical contact with humans or animals.
Infectious substances meeting the Category A criteria which cause disease in humans or
both in humans and animals must be assigned to UN 2814 (Infectious substance,
affecting humans).
Infectious substances which cause disease only in animals must be assigned to UN 2900
(Infectious substance, affecting animals).
Classification
Assignment to UN 2814 or UN 2900 must be based on the known medical history and
symptoms of the source human or animal, endemic local conditions, or professional
judgment concerning individual circumstances of the source human or animal.
Example: A patient from a foreign country is admitted to the hospital. You think
they may have Ebola. You will ship all body fluids as infectious substances
(Category A) using all the applicable packaging and paperwork.
Classification
Category B, Biological substance is an infectious substance which does no meet the
criteria for inclusion in Category A.
Example: A patient's body fluid infected with mycobacterium tuberculosis. A culture of
this same organism would be a Category A infectious substance.
You must use your professional judgment in deciding if an infectious substance is a
Category A or Category B infectious substance. Contact EHS if you need assistance
determining your classification.
Classification
Infectious substances in category B must be assigned to UN 3373 except those
organisms on table 3.6.D - which must be assigned to UN 2814 or UN 2900.
The proper shipping name of UN 3373 is Biological Substance Category B.
Classification
Exemptions
Substances in this group are not subject to these Regulations
unless they meet the criteria for inclusion in another class
(Example: Ethanol or another hazards to the sample.)


Unregulated ‘Biological Specimens’
Patient Specimens
Classification-Exemptions
Unregulated ‘Biological Specimens’





Substances which do not contain infectious substances or substances which are
unlikely to cause disease in humans or animals are not subject to these regulations
unless they meet the criteria for inclusion in another class i.e. you add ethanol to the
sample.
Substances containing micro-organisms, which are non-pathogenic to humans or
animals.
Substances in a form that any present pathogens have been neutralized or
inactivated such that they no longer pose a health risk.
Environmental samples (including food and water samples), which are not
considered to pose a significant risk of infection.
Dried blood spots, collected by applying a drop of blood onto absorbent material,
or fecal occult blood screening tests and blood or blood components which have
been collected for the purposes of transfusion or for the preparation of blood
products to be used for transfusion or transplantation and any tissues or organs
intended for use in transplantation .
Classification of Infectious
Substances
Patient Specimens
Patient specimens for which there is minimal likelihood that pathogens are present

are not subject to these Regulations if the specimen is packed to prevent any leakage and is
marked with the words "Exempt human specimen" or "Exempt animal specimen”. The
package must meet certain packing requirements.
Examples:


Excreta (urine, feces)

Secreta (saliva, sweat)

Blood or its components

Tissues and Fluids


Urine test to monitor cholesterol levels, blood glucose levels,
hormone levels


Test required to monitor organ function such as heart, liver or
kidney function for humans or animals with non-infectious disease,
or therapeutic drug monitoring
Tests conducted for insurance or employment purposed and are
intended to determine the presence of drugs or alcohol

Pregnancy tests

Biopsies to detect cancer

Antibody detection in the absence of any concern for infection
The determination of whether a specimen is consider ‘exempt human/animal specimens’ is
based on professional judgment. The judgment should be based on the know medical history,
symptoms and individual circumstances of the source, and local endemic conditions.

Specimens suspected of being infectious should be shipped as infectious agents.

Live animals or infected animal specimens are not considered exempt.
Other Classifications
Biological Products
For the purposes of these Regulations, biological products are divided into the following groups:
Those which are manufactured and packaged in accordance with the requirements of appropriate
national authorities and transported for the purposes of final packaging or distribution, and
use for personal health care by medical professionals or individuals. These include but are not
limited to finished and unfinished products such as vaccines.
Substances in this group are not subject to these Regulations.
Those which do not fall under paragraph (a) and are known or reasonably believed to contain
infectious substances and which meet the criteria for inclusion in Category A or Category B.
Substances in this group must be assigned to UN 2814, UN 2900 or UN 3373, as
appropriate.
Note: Some licensed biological products may present a biohazard only in certain parts of the
world. In that case, competent authorities may require these biological products to be in
compliance with local requirements for infectious substances or may impose other restrictions
Other Classifications
Genetically modified microorganisms are:
Organisms that do not meet the definition of infectious substances but posses
genetic material that has been purposely altered through genetic engineering in a
way that does not occur naturally.
Assigned UN 3245
UN 3245 label:
UN3245
These items must be triple packaged (leak proof primary container, leak proof
secondary container, strong outer container). Liquids must have sufficient absorbent
material to absorb all contents outside of the primary container. Outer containers
must have sender and receiver names, addresses, and phone number marked on the
box.
Other Classifications
Infected Animals
A live animal which has been intentionally infected and is known or suspected to
contain an infectious substance cannot be transported by air unless the infectious
substance contained cannot be consigned by any other means. Infected animals can
only be transported by certain carriers. With the shipment there must be a DOT
letter of authorization.
In order to receive infected animals you must obtain an import permit from the USDA.
Both a DOT letter of authorization and USDA Permit take weeks to obtain.
Identification


This process begins with a correct assessment of the
dangerous good and proper classification of it.
Classify this danger against the List of Dangerous
Goods in the Dangerous Goods Regulations.
 Biological
Hazards
 Chemical Hazards

Use the table to identify the proper shipping name,
hazard class, labels needed, packing instructions to
follow, and quantity limitations.
Identification
Category A Infectious Substance
UN/ ID
no.
A
2814
2814
2900
2900
Proper shipping
Name/Description
Class or
Div.
(Sub Risk)
B
C
Hazard
Label(s)
PG
Passenger and
Cargo Aircraft
EQ
S.P.
See 4.4
Ltd Qty
Pkg Inst
D
Cargo
Aircraft Only
E
F
Infectious substance, 6.2
affecting humans *
(solid)
Infectious
subst.
E0
Infectious substance, 6.2
affecting humans *
(liquid)
Infectious
subst.
E0
Infectious substance, 6.2
affecting animals *
only (solid)
Infectious
subst.
E0
Infectious substance, 6.2
affecting animals *
only (liquid)
Infectious
subst.
E0
G
Max Net
Qty/Pkg
H
--
--
--
--
--
--
--
--
Pkg Inst
Max Net
Qty/Pkg
Pkg Inst
ERG Code
Max Net
Qty/Pkg
I
J
K
L
M
N
620
50 g
620
4 kg
A81
A140
11Y
620
50 mL
620
4L
A81
A140
11Y
620
50 g
620
4 kg
A81
A140
11Y
620
50 mL
620
4L
A81
A140
11Y
The table from the Dangerous Goods Regulations provides a lot of critical information. The entries for infectious substances are shown here.
You will not find a microorganism listed by its scientific/technical name. There are two UN numbers: UN 2814 and UN 2900 for Category A
Infectious Substances (Column A). The asterisk beside infectious substances means you must put the technical name (specific name of the
organism) on any paperwork. You do not put the technical name on the outside of the package. Column C gives the class or division and
Column D gives the hazard label that will be affixed to the package. Columns J and L give the quantity limits per package type.
Identification
Category A Infectious Substance
Passenger and
Cargo Aircraft
Ltd Qty
Pkg Inst
Max Net
G
Qty/Pkg
H
---
Cargo
Aircraft Only
Pkg
Inst
I
Max
Pkg
Net
Inst
Qty/Pkg
K
J
Max Net
Qty/Pkg
L
620
50 g
620
4 kg
620
50 mg
620
4L
620
50 g
620
4 kg
620
50 mL
620
4L
---
--
--
--
--
This slide shows the packing instruction and maximum quantity per package. The limits are different for
passenger and cargo aircraft.
You are only allowed to ship 50mg/g per package on a passenger and cargo aircraft. You are only allowed to
ship 50mL (liquid) or 50g (solid) per package on a passenger and cargo aircraft. With the "cargo aircraft
only" label you can ship up to 4L (liquid) or 4 kg (solid) on a cargo aircraft only.
Cargo Aircraft Only Label
Identification
Biological Substance, Category B
UN/ ID
no.
A
3373
Proper shipping
Name/Description
B
Biological substance,
Category B
Class or
Div.
(Sub
Risk)
Hazard
Label(s)
C
D
PG
Passenger and
Cargo Aircraft
EQ
Ltd Qty
Pkg Inst
Max Net
Qty/Pkg
E
6.2
F
G
H
E0
--
--
Cargo
Aircraft Only
Pkg Inst
Max Net
Qty/Pkg
Pkg
Inst
Max Net
Qty/Pkg
I
J
K
L
--See 650--
S.P.
See
4.4
ERG
Code
M
N
--See 650--
The UN number 3373 is in Column A.
When shipping biological substances you have to use packing instruction 650 and you can ship up
to 4 L per outer package (primary containers cannot exceed 1 L.)
The 4L quantity excludes ice, dry ice or liquid Nitrogen when keeping specimens cold.
6L
Identification
Dry Ice
UN/
Proper shipping
Class Hazard Label(s) PG
ID no. Name/Description or Div.
(Sub
Risk)
A
B
C
D
1845
Carbon dioxide,
solid
9
Miscellaneous
E
Passenger and
Cargo Aircraft
EQ
Ltd Qty
F
E0
Pkg Inst
Max Net
Qty/Pkg
G
--
H
--
Cargo
Aircraft Only
Pkg Inst
Max Net
Qty/Pkg
Pkg Inst
Max Net
Qty/Pkg
I
J
K
L
954
200 kg
954
200 kg
S.P.
See 4.4
ERG
Code
M
N
A48
A151
9L
Several of these entries for dry ice look alike. The one you want is UN 1845, Class 9.
The Packing Instruction when filling out the Dangerous Goods Declaration is 954.
Identification
Biological Products
UN/ ID
no.
Proper shipping Name/Description
Class or Div.
(Sub Risk)
Hazard
Label(s)
PG
Passenger and
Cargo Aircraft
EQ
Ltd Qty
Pkg Inst
Max Net
Qty/Pkg
A
B
Biological products +
Manufactured and packaged in accordance
with
the
requirements
of
national
governmental
health
authorities
and
transported for the purposes of final
packaging or distribution, and use for
personal health care by medical professionals
or individuals
C
D
E
F
G
Cargo
Aircraft Only
Pkg Inst
Max Net
Qty/Pkg
Pkg Inst
Max Net
Qty/Pkg
I
J
K
L
H
----NOT RESTRICTED----
There is no UN number in the left hand column for biologicals. It states they are not restricted. You
do not need diamond shaped labels and you can ship as much as you want as long as no
chemicals or infectious agents are present.
Chemical Preservatives
Solutions used to preserve biological samples may be regulated as dangerous
goods.




Ethanol, greater than 24% is assigned to UN1170, Class 3,
Ethanol, PGII
10% to <25% Formaldehyde is assigned to UN3334, Class 9,
Aviation regulated liquid, n.o.s.
Formaldehyde, not less than 25% assigned to UN2209, Class 8,
Formaldehyde solution PGIII
Formaldehyde combined with a flammable substance may
qualify as UN1198, Class 3 (Sub risk 8), Formaldehyde solution,
flammable.
Call EHS for specific packaging and training before shipping chemicals
Packing Groups
Packing groups apply to toxic substances and chemicals but not infectious substances, biological products or
Category B biological substances. The packing groups pertain to performance test requirements. They are
assigned with regard to the relative degree of danger of the article or substance.
Packing Group
Hazard Level
I
High Hazard
II
Moderate Hazard
III
Low Hazard
Here is an example of the packing group criteria for class 3 materials (flammable liquids)
Packing Group
Flash Point (closed cup)
I
Initial Boiling Point
Less than or equal to 35° C
II
Less than 23° C
III
Equal to or greater than 23° C
but less than or equal to 60.5° C
Greater than 35° C
The IATA DGR establishes packing group assignments for all applicable classes based on the type of hazard.
For example Class 8 materials are assigned packing groups based on corrosivity and Class 6.1 materials
are assigned based on toxicity.
Packing Groups
The packing group for a material is indicated on the table in the Dangerous Goods Regulations.
Here is an example using the listing for Ethanol.
Ethanol has two packing groups listed (column E). The flashpoint of your ethanol solution will
determine which packing group and packing instructions to use. Check the SDS for flashpoint
information.
UN/ ID
no.
Proper shipping
Name/Description
A
1170
Class or
Div.
Hazard Label(s)
(Sub
Risk)
B
Ethanol
C
3
D
Flamm. liquid
PG
Passenger and
Cargo Aircraft
EQ
Ltd Qty
E
F
II
III
E2
E1
Pkg Inst
Max Net
Qty/Pkg
G
H
Y341
Y344
1L
10 L
Cargo
Aircraft Only
S.P.
See
4.4
ERG
Code
Pkg Inst
Max Net
Qty/Pkg
Pkg Inst
Max Net
Qty/Pkg
I
J
K
L
M
N
353
355
5L
60 L
364
366
60 L
220 L
A3
A58
A180
3L
3L
Dangerous Goods in Excepted
Quantities



There are 2 provisions in the Dangerous goods regulations that allows small quantities of some dangerous
goods to be shipped as "dangerous goods in excepted quantities” or “dangerous goods in deminis
quantities”
This is very useful for small amounts of hazardous chemicals.
Check the EQ column (column F) on the Dangerous Goods Table for the material to find the Excepted
Quantity code.

Reference table 2.7 to determine the quantity allowed under your item's code.

Some materials are not allowed to ship as Excepted Quantities. These will have an E0 in column F
UN/
Proper shipping Class
ID no. Name/Description
or
Div.
(Sub
Risk)
A
B
Hazard
Label(s)
PG
Passenger and
Cargo Aircraft
EQ
Ltd Qty
Pkg Inst Max Net
Qty/Pkg
Cargo
Aircraft Only
Pkg Inst
Max Net
Qty/Pkg
Pkg Inst
D
E
F
G
H
I
J
K
Toxic
III
E1
Y645
10 kg
670
100 kg
677
C
2516

Carbon
tetrabromide
6.1
For the EQ table, click here: table 2.7
Max
Net
Qty/Pkg
L
200 kg
S.P.
See
4.4
ERG
Code
M
N
6L
Dangerous Goods in Excepted
Quantities
This form can be downloaded at
http://ehs.unc.edu/ih/lab/docs/excepted.pdf.
It needs to be printed on a color printer.
In the upper box you will type the Class number(s), with
sub risks in parenthesis. This is found in column C of
the Dangerous Goods table.
In the lower box you will type either your name and
address or the recipient's name and address IF it is
not already marked ON the package.
This label along with an address label placed on a strong
outer box is what is needed for shipping excepted
quantities of chemicals not forbidden for transport.
The material must be in a leak proof primary container. The primary container needs to be taped closed.
This primary container must be securely packed in a secondary container with absorbent/cushioning material in such a
way that the primary container will not break, puncture, or otherwise release its contents.
The secondary container must be securely packed in a strong rigid outer packaging (wood, cardboard, or other equally
strong material).
Each outer package must be large enough to apply all necessary markings.
Dangerous Goods in Excepted
Quantities
Excepted Quantity Package Test
The complete package must be capable of withstanding the following drop and load
tests. This must be demonstrated by testing and appropriately documented using this
form.
Excepted Quantity Package Test Verification Form
(http://ehs.unc.edu/ih/lab/docs/eq_test_form.pdf)
For the purposes of testing you will use a substance with similar physical characteristics
(mass, grain size, density, etc.) to the item you intend to ship. Fill the primary
container to 98% capacity.
Triple package this substance in identical primary, secondary (including
absorbent/cushioning), and outer containers to what you intend to use for shipping
and perform the following tests:
Dangerous Goods in Excepted
Quantities
Drop Test:
From a height of 1.8 m (5.9 feet), perform each of the following drops onto a rigid,
non-resilient flat and horizontal surface:
Flat on the base
Flat on the top
Flat on the longest side
Flat on the shortest side
On a corner
Load Test:
Calculate the mass of identical size and weight packages as your test sample if stacked
to a height of 3 m (10 feet). Apply this amount of force to the top surface of your
package for 24 hours.
Dangerous Goods in Excepted
Quantities
A successful package test results in no leakage or breakage of the inner containers and
no significant reduction in effectiveness of any of the 3 layers of packaging.
Remember to document this package test using this form
(http://ehs.unc.edu/ih/lab/docs/eq_test_form.pdf)
If you are using packing materials and specimens that you have previously tested and
documented you do not need to re-test the package. You may use a copy of the
package test verification form from a previous test of the same materials. Make
sure you keep a copy of the package test verification form in your shipping records.
Dangerous Goods in Excepted
Quantities
Here is an example of the label for a package containing an excepted
quantity of a Class 3 flammable liquid.
Dangerous Goods in Excepted
Quantities
Many people ship their biological samples in formalin or ethanol to preserve them.
Packing instructions 620 (UN2814 and 2900 Category A infectious substances) and
650 (UN3373 Biological Substances, Category B) allow for a quantity of 30mL or
less of dangerous goods in classes 3, 8, or 9 to be packed in each primary
receptacle containing infectious substances. This includes commonly used
preservatives such as formalin, ethanol, or formaldehyde.
When these small quantities are packed with infectious substances using the packing
method for that infectious substance, the excepted quantity label is not required.
The infectious substance packaging will be sufficient.
This does not include phenol, which is a class 6 chemical.
Dangerous Goods in Excepted
Quantities
EQ Values for Chemicals Commonly Shipped in Small Quantities
Common Name (Proper
Shipping Name)
Class or Division Packing Group
(Sub. Risk)
Ethanol
3
EQ
II
E2
III
E1
Formaldehyde 10% to <25% 9
(Aviation regulated liquid,
n.o.s.)
III
E1
Formaldehyde solution
(Formaldehyde, not less than
25% )
8
III
E1
Formaldehyde solution,
flammable
3(8)
III
E1
Phenol solution
6.1
II
E4
III
E1
Dangerous Goods in De Minimis
Quantities

Dangerous Goods assigned codes E1, E2, E4 or E5
do not required Excepted Quantity or any hazard
labeling provided:
 The
maximum quantity of material per inner container
is 1 ml/1 g or less.
 The maximum net quantity per packaging does not
exceed 100ml/100g.

Excepted Quantity package test must still be
preformed.
Shipping With Formalin
Shipper's Declaration for Dangerous Goods
Many people ship large amounts of formalin to preserve their specimens. Here is an
example of the Shippers Declaration for Dangerous Goods when shipping formalin.
If you are shipping formalin or any other chemical, you need to call EHS at 919 962 - 5507 for more in-depth training.
Packaging and Documentation
Packaging
Selecting Proper Packaging
Selecting the proper packaging is one of the most important functions of the
shipper. With proper packaging you ensure the safety of those who may
handle or unpack the contents of the package. Proper packaging ensures
that the material is not released during transportation.
The shipper is responsible for all aspects of the packing of dangerous goods.
The carrier (FedEx, DHL, UPS, etc.) will not help you package your material.
Packaging
Selecting Proper Packaging
The shipper must comply with the following packing instructions:

UN2814 or UN2900 Category A infectious substances use Packing Instruction 620
pdf

UN3373 Category B infectious substances use Packing Instruction 650 pdf

UN1845 Dry Ice use Packing Instruction 954 pdf
Biological Substances Category B
Packaging
Category B Specifications
These are the minimum packaging requirements for Packing Instruction 650:


The packagings must be of good quality, strong enough to withstand the shocks and
loadings normally encountered during transport, including trans shipments.
"Packagings must be constructed and closed so as to prevent any loss of contents
that might be caused under normal conditions of transport, by vibration or by
changes in temperature, humidity or pressure."
The packaging must consist of three components:

Primary receptacle(s)

Secondary packaging(s)

Rigid Outer Packaging
Biological Substance Category B
Packaging
Biological Substance, Category B Packaging Requirements

Primary receptacle(s) must be leakproof and contain
no more than 1L

Secondary packaging must be leakproof

If multiple fragile receptacles are in a single secondary
package they must be individually wrapped or separated
to prevent contact

Sufficient absorbent material must be placed between
the primary and secondary receptacles.
Primary receptacle
Biological Substance Category B
Packaging
Packaging Materials for Category B Substances
Notes: You do not need special absorbent. Cotton balls or paper towels may be used.
Biological Substance Category B
Packaging
Biological Substance, Category B Packaging Requirements


Place Primary Packaging in Secondary Packaging
The primary receptacle or the secondary packaging must
be able to withstand, without leakage, an internal
pressure test of 95 kPA in the range of -40° C to 55° C.


When you are ordering shipping materials make sure you
order primary or secondary containers that meet the 95
kPA.
Examples: Secondary packaging that meets the 95 kPA
requirement.

Top: tyvek pouches, Bottom: plastic canisters

Notice the biohazard symbol on the packaging. It is an
OSHA (not an IATA) requirement when shipping blood or
other potentially infectious material.
Biological Substance Category B
Packaging
Biological Substance, Category B Packaging Requirement



An Itemized list of contents is required. It is place between the
secondary packaging and outer packaging.
Outer packaging must be marked with the following:

The name, address and telephone number of a responsible person.

UN 3373 must be marked on the outside of the box adjacent to the
words Biological Substance Category B.

Biological Substance Category B hazard label
The completed package must be able to pass a drop test of 1.2
M on all sides.

The biohazard symbol is not required on the outer box.

Make sure your specimens do not move about loosely in the box.

It is useful many times when shipping out of the country to put
"For Research Purposes Only" on the outside of the box.
Biological Substance Category B
Packaging
Biological Substance Category B
Packaging
US Postal Service Label Requirement for Specimens OSHA "Biohazard
Label"
The U.S. Postal Service accepts Biological Substance Category B. You no longer
display the Biohazard symbol on the outside. If you are shipping chemicals
or blood or other potentially infectious materials using the U.S. postal
service please call EHS at 919 - 962 - 5507.
Exempt Human Specimens
Packaging
Patient Specimens, Packaging Requirements




The marked with the words "Exempt human specimen" or "Exempt animal specimen",
as appropriate
The packaging must consist of three components:

a leak-proof primary receptacle(s);

a leak-proof secondary packaging; and

an outer packaging of adequate strength for its capacity, mass and intended
use, and with at least one surface having minimum dimensions of 100 mm x 100
mm;
For liquids, absorbent material in sufficient quantity to absorb the entire contents
must be placed between the primary receptacle(s) and the secondary packaging so
that, during transport, any release or leak of a liquid substance will not reach the
outer packaging and will not compromise the integrity of the cushioning material;
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
Shipping With Dry Ice




Dry ice is always considered a

Dangerous good

It must always be declared by marking, labeling, (Class 9) and documentation.
If there are no other dangerous goods in a shipment, a Shipper’s Declaration is not
required (red hatch-mark form).
Outer packaging must be marked with the following:

UN 1845 must be marked on the outside of the box adjacent to the words Dry Ice

Class 9 misc. hazard label

Weight of dry ice in kgs
Dry ice is never placed in a sealed container. The package must be able to
release vapor at all times. The lid of a Styrofoam cooler should not be taped in
place. Tape the outer cardboard box. Even when transporting dry ice by ground,
basic safety precautions should be followed. Allow ventilation of the cooler and the
vehicle. CO2 can build up in a car with the windows rolled up.
Shipping With Dry Ice
Here is an example of the "Special Handling" box of the Air Waybill (FedEx):

The proper Shipping Name box should be checked

The Class Number 9 (misc) is printed on the form-fill in the amount of dry ice

The UN Number UN1845 should be on the form

One of the following boxes must be checked

Does this shipment contain dangerous goods?
Wet ice or blue ice packs are not considered dangerous goods. Pack both so the package does
not leak.
If you are shipping Biological Substances Category B with wet ice, blue ice, dry ice, or at ambient
temperatures you need to check the box. "Yes" (Shippers declaration not required). If you are
shipping Infectious Substance Category A on dry ice you will check 'yes' (as per attached
shipper's Declaration).
Shipping With Dry Ice

Every package containing dry ice must have a Class
9 Miscellaneous hazard label (minimum size 4 in x 4
in):
For a .pdf version of this label go here:
http://ehs.unc.edu/ih/lab/docs/dry_ice.pdf
Note: Labels must be weather resistant. If
you use the paper label in the link above be
sure to completely cover it with clear packing
tape when you attach it to the box.
Shipping With Dry Ice
Effective October 1, 2014
Per DOT regulations, Class 9 hazard labels with the horizontal line
will no longer be accepted.
Infectious Substances Category A
Packaging
Packing Specifications Infectious Substances (Category A)
Here are the most important requirements for Packing
Instruction 620:

watertight primary receptacle

watertight secondary packaging



Either the primary or secondary container must be
capable of withstanding without leakage an internal
pressure producing a pressure differential of not less
than 95 kPa and temperatures in the range of -40°
C to 55° C.
absorbent material, if liquid
itemized list of contents between the secondary and
outer container

UN certified outer packaging

at least 100mm x 100 mm (4 in x 4 in.)
Infectious Substances Category A
Packaging
UN Certified Packaging



There are several requirements for certified packaging. One requirement for
certified packaging is a drop test.
A prototype of the package, properly packed with its filled primary and secondary
containers, is dropped from a height of 30 feet on all sides and a corner. It is then
subjected to an hour of rainfall and dropped on all sides again. Following the drop
test there must be no leakage from the primary receptacles which must remain
protected by absorbent in the secondary packaging. Another test to meet UN
certified packaging is the puncture test.
The UN certification stamp on the box certifies that the package has been subjected
to and passed all required tests. The UN certification stamp looks like this:
U
N

4G/CLASS 6.2/07 DK/
SP-9989-ERIKSSON
The UN Certification Symbol is pre-printed on the tested boxes. Under no
circumstances must you write the UN certification mark on the box.
Infectious Substances Category A
Packaging
UN Certified Packaging


A UN Certified box is tested with a
primary and secondary container. Do not
change out the components of the box.
Ship the box the way it was originally
tested to ensure its integrity.
Packages are expensive but reusable.
When shipping a box back to a
collaborator, deface labels (do not tear
them off) and mark it as empty.
In order to reuse an infectious shipper cut
the tape to open - do not tear the tape
off the box.
Infectious Substances Category A
Packaging
Fisherbrand Biohazard Mailers
Take care when selecting your packaging. You cannot ship infectious material from
Category A in these cardboard tubes. You will notice there are no UN markings.
These should only be used when shipping exempt specimens or Category B
materials. When shipping Category B materials make sure the mailer you buy
meets the 95kPa pressure test.
Infectious Substances Category A
Packaging
Infectious Substance, Category A Packaging
Requirements

Primary containers must be glass, metal or plastic
(leave room for expansion)


Maximum net quantity per package-50ml
Secondary packaging must be leakproof

If multiple fragile receptacles are in a single secondary
package they must be individually wrapped or
separated to prevent contact


Sufficient absorbent material must be placed between
the primary and secondary receptacles.
Plastic Primary receptacles capable of withstanding
very low temperatures should be used when shipping
with liquid nitrogen.
Primary receptacle
Infectious Substances Category A
Packaging
Infectious Substance, Category A Packaging Requirements

The primary receptacle or the secondary packaging must
be able to withstand, without leakage, an internal
pressure test of 95 kPA in the range of -40° C to 55° C.


When you are ordering shipping materials make sure you
order primary or secondary containers that meet the 95
kPA.
Examples: Secondary packaging that meets the 95 kPA
requirement.

Top: tyvek pouches, Bottom: plastic canisters

Notice the biohazard symbol on the packaging. It is an
OSHA (not an IATA) requirement when shipping blood or
other potentially infectious material.
Infectious Substances Category A
Packaging
Requirements





Place primary packaging in secondary packaging
Put the secondary packaging along with the
itemized list of contents in the support package.
The interior support packaging secures the
secondary package as the dry ice
dissipates. Contents of your package should not
move around inside the package unsecured.
Place insulated container inside UN certified outer
packaging with UN Specification marks.
Remember do not tape the lid of the insulated
cooler. Tape only the outer box.
Infectious Substances Category A
Packaging
Requirements
Marking and Labeling of Outer Packaging for Infectious Substances Shipped with Dry
Ice
1.
Class 6.2, infectious label
2.
Dry Ice name and quantity label
3.
Class 9, dry ice label
4.
UN packaging certification
5.
Orientation marks, 2 sides
6.
Consignee address and phone number
7.
Shipper with phone # of person responsible
8.
Proper shipping name, technical name, UN
number and net quantity of infectious substance
Effective October 1, 2014
Per the DOT regulations, the Class 6 Infectious Substance label with the text ‘In U.S.A. Notify Director-CDC,
Atlanta, GA 1-800-232-0124’ will no longer be allowed.
Do not use this version of the Class 9 label,
effective Oct. 1, 2014.
Use the new version, which has the “In U.S.A.
Notify Director-CDC, Atlanta, GA 1-800-2320124” removed.
Shipping With Overpacks
Overpacks are large packages capable of containing one or more smaller packages.
Many people use the MediPak diagnostic shipper with an inner UN 6.2 infectious
shipper box.
Dangerous goods packages within the overpack must be correctly packed, marked,
labeled and in proper condition.
Shipping With Overpacks
The overpack must have on the outside of the box:

All necessary marks and labels.

If the UN package specification marks are not
visible, a statement that says "Overpack" must
appear on the outside package.
UN Package Specification Marks
Required on inner package of overpack containing infectious substances.
Shipping With Overpacks
Labeling the Overpacks for Infectious Substances
The overpack must be labeled in the following way:





A Division 6.2 Infectious Substance Hazard Label next to the proper shipping name and UN
number (UN 2814)
Net quantity of infectious substance adjacent to proper shipping name
Package Orientation labels (up arrows) on opposite sides of the overpack if not pre-printed
on the box.
A Class 9 label (if Dry Ice is used).

Other dangerous goods must not be packed in the same package as infectious substances
unless they are needed for maintaining viability, stabilizing or preventing degradation or
neutralizing the hazards of infectious substances. A quantity of 30 mL or less of dangerous
goods included in classes 3 (ethanol), 8 (formaldehyde), 9 (formalin) may be packed in
each primary receptacle containing infectious substances NO excepted quantity label is
needed.

An overpack does not need to be a UN certified package. It can be a strong, recycled
box.
An example of a much used overpack is the UN Certified smaller box inside the outer
Medifreeze box.
Infectious Substance Documentation

Shipper’s Declaration of Dangerous Goods
 The
document is a sworn statement to the carrier that
the shipment has been prepared in accordance with the
regulations
 As a legal document, the Declaration binds the shipper
to its terms and conditions
 It is not required for Category B and Exempt shipments
(patient specimens, biological products, excepted
quantities, de minimus quantities)
Infectious Substance Documentation






The Shippers Declaration is required to be kept for 2 years (domestic) / 5
years (international).
All Shippers Declarations must be typed.
A typed signature is unacceptable
 A signature can be handwritten, stamped or a facsimile
A physical address is needed on the paperwork and box - no P.O. Boxes
Only the shipper is authorized to complete and sign the Shipper’s
Declaration for Dangerous Goods
The person who signs the DG Declaration must be trained and certified.
Infectious Substance Documentation
3
4
1
2
5
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6
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7
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7b
7c 7d
7e
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Infectious Substance Documentation
3
4
1
2
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6
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7
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7b
7c 7d
7e
7f 7g
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Infectious Substance Documentation


The shippers declaration will differ based on how
the shipment is packaged, i.e. if shipping with dry
ice or using an overpack.
Contact EHS for assistance with completing the
shippers declaration of dangerous goods.
Infectious Substance Documentation
Reminders
□
Listing all classes of Dangerous Goods, remember that dry ice is a Class 9
Dangerous Good
□
Include emergency response information.
□
When shipping out of the U.S. a commercial invoice is also required for customs.
□
□
An import permit from the country you are shipping to may also be needed when
shipping.
A letter of explanation on UNC letterhead will aid your shipment through customs.
Infectious Substance Documentation
Reminders
A fillable template with instructions for completing it can be found here:
http://ehs.unc.edu/ih/lab/generic.shtml
As of January 10, 2011 FedEx will not accept a Dangerous Goods
Declaration created using this template (other carriers will). You must use a
Dangerous Goods Declaration created using specific FedEx software.
Contact EHS for more information on completing Dangerous Goods
Declarations for FedEx shipments.
Infectious Substance Documentation
24-Hour Emergency Number

Chemtrec is UNC-CH’s 24 hour contact number in the event of an emergency

1-800-424-9300 within the U.S. – when out of the country (703-527-3887)



You must also put your non-emergency number on the shipping papers (in the
to/from section).
Not acceptable on shipping papers:

Pager number

CDC reporting number
Before shipping you must fax Chemtrec a Safety Data Sheet on your material (Fax
number: 1-703-741-6037) or email it to shipping@ehs.unc.edu. You only fax it
once. It is put into their database. Make sure you write UNC-Chapel Hill on the
cover page of your fax. If you ship hazardous materials and you do not have an
emergency number listed on the paperwork you can be subject to significant fines.
Infectious Substance Documentation
SDS for Emergency Response
Health Canada has a web site that provides safety data sheets on infectious
agents. You can find them at the following web site: http://www.phacaspc.gc.ca/msds-ftss/#p
If you cannot find what you need you can write your own.
Emergency Response and Security
Plans
Emergency Response
Damaged Shipment
How do you know that a package contains dangerous goods? Look for the red
hatch marks on paperwork, UN # and diamond shaped labels on box.

A damaged package may be crushed or leaking.

Do not sign for packages without seeing them

Inspect package before signing

Do not accept a package that is damaged

Packages are the responsibility of the Shipper until accepted by recipient

If the package is damaged or leaking offer assistance in cleaning up the
spill (call EHS). The carrier should be prepared to deal with the spill.
Emergency Response
Emergency Response for Damaged Package or Spill on Campus


In a laboratory setting it is expected that staff are prepared to cope with a spill.
All labs should have an emergency spill kit on hand and train all personnel in
appropriate emergency response.

Isolate spill or leak area immediately in all directions.

Keep unauthorized personnel away.



Obtain identity of substance involved if possible and report spill to appropriate
authorities.
Do not touch or walk through spilled material.
Do not touch damaged containers or spilled material unless wearing appropriate
protective clothing.
If you need to, call EHS (919 - 962 - 5507) to help with spill clean up.
Emergency Response
Emergency Response for Damaged Package or Spill on Campus


Be very careful to avoid contact with broken glass or sharp objects that
may cause cuts or abrasions that could significantly increase the risk of
exposure.
Damaged packages containing solid CO2 as a refrigerant may produce
water or frost from condensation of air. Do not touch this liquid as it could
be contaminated by the contents of the package.
Emergency Response
Emergency Response for Damaged Package or Spill on Campus





Liquid nitrogen may be present and can cause severe burns.
Absorb spilled materials with earth, sand or other non-combustible material
while avoiding direct contact.
Cover damaged package or spilled material with damp towel and keep
wet with liquid bleach of other disinfectant
Evaluate potential personal exposure
Contact UNC Employee Occupational Health Clinic (919-966-9119) for
post exposure follow-up
Security Plan


If you ship High Consequence dangerous goods you should adopt,
implement and comply with a security plan that addresses the elements
specified in section 1.6.3.2 of the IATA Dangerous Goods Regulations
High consequence Dangerous Goods are those that have the potential for
misuse in a terrorist incident and which may as a result produce serious
consequences. They include 1.1, 1.2, 1.3 explosives; 2.3, toxic gases; 6.1
toxins; 6.2 infectious substances; 7 radioactive materials.
Security Plan


Labs need to take specific action in order to provide security against theft
of highly hazardous materials, and to ensure compliance with new
regulations.
EHS urges each lab/clinic to review and develop procedures to ensure the
security of hazardous materials in your area.
Security Plan





Many of you already implement security measures
 Locking up controlled substances, syringes, and needles
 Securing radioactive material
An easy way to increase laboratory security is to lock the lab
whenever it is left unattended
Keep records of dangerous good or types of dangerous goods
transported
Review how you store your dangerous goods
Put in place procedures for reporting and dealing with security
threats, breaches of security, or security incidents
Security Plan




You should control access to areas where hazardous chemicals are used and
stored
Lock freezers, refrigerators where biological agents, hazardous chemicals
or radioactive materials are stored
Approach anyone you don't recognize who appear to be wandering in lab
areas
Assign security responsibility to one employee in your lab. Give them
appropriate authority to carry out their responsibilities.
Security Plan





Use a log book to sign highly hazardous materials in and out of secure
storage
Take a periodic inventory of highly hazardous chemicals, biological
agents/toxins, radioactive material and controlled substances
 This could be as simple as frequently looking at your chemical containers
to make sure none are missing
Track the use and disposal of hazardous materials. Report any missing
inventory to Public Safety or EHS.
Know what materials are being ordered and being brought into the
laboratory
Consider having all lab staff wear identification badges
Other Regulatory Requirements and
Examples
Contact for Packaging Materials





inmark, inc.
Atlanta, GA
800-646-6275
www.inmarkinc.com
SAF-T-PAK
Edmonton, Alberto, Canada
800-814-7480
www.saftpak.com
CARGOpak, Corp.
Raleigh, NC
800-266-0652
www.cargopak.com
Fisher Scientific
800-766-7000
www.fishersci.com
Contact your carrier for specific information regarding the shipment of Category B and
Category A infectious substances.
Other Regulatory Requirements




When importing pathogens that affect poultry or livestock a USDA permit is needed from the Animal and Plant Health
Inspection Service (APHIS)
When importing plants, animals, insects, earthworms, soil, etc., you also need an import permit.
For items not needing an APHIS import permit (human cell, culture, serum, blood) a guideline letter is required. The letter will
aid your shipment through customs.
Centers for Disease Control & Prevention



A permit is required for the importation of certain etiological agents
Select agent transfers require a Form 2 permit.

Facilities transferring or receiving select agents must be registered with CDC

Each transfer of a select agent must be documented

Contact EHS for more information
Department of Commerce licenses are required when exporting specific biological agents, genetic elements of these agents,
toxins, certain chemicals and equipment. Contact EHS prior to exporting materials from your lab for an Export Control
evaluation.
OSHA – Blood & Bloodborne pathogens training is required if you work with blood, other potentially infectious substances, or
human cell culture. (if you have complied with OSHA's BBP you have not complied with shipping regulations)

Shipping overseas can be quite complicated because you need to consider the requirements of the receiving country.

These additional requirements can take up to a month to accomplish - plan your shipment!

Call the EHS Shipping Specialist for help.
Vapor Shipper
Liquid Nitrogen





Liquid Nitrogen is a dangerous good that has specific package
requirements:
It is a class 2.2 Non-flammable, non-toxic gas assigned to UN 1977
Nitrogen, refrigerated liquid (If packaged with the vapor shipper it is
exempt. You do not need a non flammable 2.2 label. Nor do you declare
the liquid nitrogen on the shipping papers)
Insulated packagings (vapor shipper) containing refrigerated liquid
nitrogen fully absorbed in a porous material and intended for transport, at
low temperature are not regulated.
When using a vapor shipper the words "Not Restricted" and the special
provision number "A152" must be included in the description of the
substance on the airway bill.
A152 must also be typed in the "authorization" column of the Dangerous
Goods Declaration.
Vapor Shipper
Follow manufacturers directions to properly
prepare vapor shipper. The blue layer is
porous. After charging the shipper, pour
off the excess liquid nitrogen. They cost
from $600 - $5000. Vapor shippers can
maintain freezing temperatures for up to
three weeks.
If you are shipping infectious substances in a
vapor shipper make sure the shipper is
IATA/ICAO certified to ship infectious
substances.
The 6.2 label and proper shipping name are
required on the outside of the shipper
when transporting infectious substance.
Examples
Decide whether sample should be shipped as
infectious substance or exempt specimen.
Examples
Example #1
A patient (from South Africa) is ill with symptoms
of hemorrhagic fever. You are given the task of
sending blood samples for confirmation of
Ebola to the Centers for Disease Control and
Prevention in Atlanta, GA.
 Category A Infectious Substance
 Category B Biological Substance
 Exempt Human Specimen
Examples
Example #2
In a clinical lab you are given a pleural sample
to be tested for M. tuberculosis. You culture it
then send it off for confirmation. When sending
it off are you going to classify as infectious or
diagnostic?
 Category A Infectious Substance
 Category B Biological Substance
 Exempt Human Specimen
Examples
Example #3
Your collaborator sent you the laboratory strain
of Francisella tularensis you wanted the live
vaccine strain: you need to send it back to
them.
 Category A Infectious Substance
 Category B Biological Substance
 Exempt Human Specimen
Examples
Example #4
Your lab has been told to send off for
investigational purposes spinal fluid taken from
a hospital patient. You are asked to send it off
to test for several diseases including meningitis.
 Category A Infectious Substance
 Category B Biological Substance
 Exempt Human Specimen
Examples
Example #5
Your lab is conducting a study on the effect of
folic acid and early pregnancy in 120 healthy
women. You are required to send off blood,
saliva, and fecal material for folic acid level
analysis.
 Category A Infectious Substance
 Category B Biological Substance
 Exempt Human Specimen
Examples
Example #6
You are involved in a drug study on campus that
involves 50 research subjects. Seven of those
patients are positive for having syphilis. The
other 43 people are healthy adults. How will
you send this shipment?
 Category A Infectious Substance
 Category B Biological Substance
 Exempt Human Specimen
Summary
Compliance with the hazardous materials shipping regulation is not easy.


Work out the details
Don't hesitate to ask for assistance-call FedEx, Airborne, UPS, etc. Call EHS
(919 - 962 - 5507)

Protect yourself, your coworkers, the public

Hazard communication is fundamental (labeling, labeling, labeling)
In order to receive credit for this training, you must complete the post-test