Transport of Biological Materials
Covering the classification,
packaging and labelling
of biological materials
for transport in the UK
and abroad
Dr Joanna Marshall
University Biological Safety Adviser
University of Edinburgh
Reference documents and
information source
Health and Safety Department website:
http://www.safety.ed.ac.uk/resources/Bio/
Guidance/Index.html
Various sections, Transport includes
- Detailed guidance on transport of biological
materials *essential reading*
- Specialist dangerous goods couriers
- Suppliers of specialist packaging
Individual workers responsibilities
That means YOU!
International agreements for
transport of dangerous goods
UN Recommendations/ Model
Regulations form basis for international,
national, regional and modal regulations
Road
Rail
Air
Sea
ADR
RID
ICAO (IATA)
IMDG
Road transport
• The Carriage of Dangerous Goods and
Use of Transportable Pressure Equipment
Regulations 2004
– cross references to ADR (& RID)
Depending on the material other
legislation may also apply, such as
• The Genetically Modified Organisms
(Contained Use) Regulations 2000
Air transport
• Technical Instructions for the Safe
Transport of Dangerous Goods by Air
– ICAO
• Dangerous Goods Regulations
– IATA
Applicability
• When transported by road by any means
– except carriage between one part of the
University and another part situated in the
immediate vicinity
– even if carry package yourself
• When transported by air
– no exceptions
– restrictions on how package carried
A key point on air transport
• Dangerous goods must not be carried by
passengers as/or in
– checked baggage
– carry-on baggage or
– on their person
Dangerous goods must always be
transported as separate packages in the
hold and must always be declared
"Dangerous Goods" for carriage
• Criteria defined under 9 UN hazard
classes
• Classify and assign UN number and
proper shipping name
• Each has entry in Dangerous Goods List
which indicates
–
–
–
–
limitations
packaging
labelling
special provisions
Class 6.2 - Infectious substances
• Substances known or reasonably expected
to contain pathogens
• Can cause disease in humans or animals
• Certain biological materials meet
definition
– stringent requirements for classification,
packaging and labelling
• Consider any other hazardous properties
• Other biological materials
– specific requirements to package safely
UN numbers and proper shipping
names
• UN 2814
INFECTIOUS
HUMANS
SUBSTANCE,
• UN 2900
INFECTIOUS SUBSTANCE,
ANIMALS ONLY
AFFECTING
AFFECTING
UN numbers and proper shipping
names
• UN 3373
DIAGNOSTIC SPECIMENS or CLINICAL
SPECIMENS
• UN 3291
CLINICAL WASTE, UNSPECIFIED, N.O.S.,
(BIO) MEDICAL WASTE, N.O.S. or
REGULATED MEDICAL WASTE
2005 - revised categorisation
scheme
• Based on risks during transport rather than
risks associated with lab work
• Assign UN number depending on whether
Category A or Category B
Category A
– an infectious substance which is carried
in a form that, when exposure to it occurs,
is capable of causing permanent disability,
life-threatening or fatal disease to humans
or animals
• Refer to indicative list (not exhaustive)
• Assign to
UN 2814 or UN 2900
Category B
– an infectious substance which does
not meet the criteria for inclusion in
Category A
Assign to
UN 3373
except cultures
Cultures, stocks, etc
• Items containing high concentration or
titre of micro-organisms
– cultured/propagated/amplified/manipulated
– either deliberately or unintentionally
• If infectious for humans or animals
always Category A irrespective of
whether micro-organism on indicative list
Assign to UN 2814 or UN 2900
• Others not controlled
Other materials that may contain
infectious substances
• Assign to either Category A or Category
B where appropriate
• Not controlled if
– material not derived from humans or animals
– possibility, but low probability, contain
pathogens, and
– concentration at natural levels
Examples include foodstuffs, water and
environmental samples
Samples from humans or animals
• Minimum Category B
Assign to UN 3373
• Specific samples Category A on basis of
–
–
–
–
medical history and symptoms
endemic local conditions
professional judgement on source material
individual circumstances
Assign to UN 2814 or UN 2900
Important note for air transport
• Some operators apply additional
restrictions
• See Operator Variations
– eg AF-04 and LH-12
Blood and tissues carried only as UN 2814 or
UN 2900
Genetically modified
micro-organisms (GMMs)
•
If harmful to humans or animals
(require CL2 or above for lab work)
Assign to UN 2814 or UN 2900
•
Others not controlled
except for certain vectors ….
Non-infectious GMMs
• If requires CL 1 for handling but is capable of
altering animals, plants or microbiological
substances (when in contact with them) in a way
not normally the result of natural reproduction
then classified in
Class 9 - Miscellaneous dangerous goods
Assign to UN 3245
with proper shipping name
GENETICALLY MODIFIED
MICRO-ORGANSIMS
Other materials subject to controls
•
•
•
•
Genetically modified organisms
Infected live animals
Biological products
Wastes from bio-research
Refrigerated/cooled materials
• Typically use either wet or dry ice
• Both may affect packaging
• Dry ice on Dangerous Goods List
UN 1845 CARBON DIOXIDE, SOLID
– Minimal requirements for road transport
– Various requirements for air transport
• Avoid using liquid nitrogen
– contact UBSA for advice
Biological materials NOT classified
as "Dangerous Goods" for transport
• Micro-organisms that are not human or animal
pathogens
• GMMs that can be handled at CL 1 and are not
vectors (and plasmids, naked DNA etc)
• Samples from non- human and non-animal
sources, that are either unlikely to contain
pathogens or may do so at natural level
• Blood, tissues or organs collected for blood
transfusion, preparation of blood products or for
transplant (all in humans)
Packaging
• All use triple layer system
• For some must use UN type-approved
packaging
• No limits on quantities per package for
road transport
• Quantity limits on packages (and some
primarys) for air transport
• Procedure and type specified in applicable
Packing Instruction
Triple layer system
• Leakproof primary receptacle
– wrapped in sufficient absorbent material to
absorb the entire contents
• Leakproof secondary receptacle
• Outer packaging (rigid)
Enclose paperwork between secondary and
outer
Either the primary or secondary must be able to
withstand 95kPa pressure differential
UN type-approved packaging
• Tested against specified criteria by an approved
testing laboratory
• Allocated a unique mark by competent
authority, this must be shown on package
• Mark includes code showing the type(s) of
dangerous goods the particular packaging
approved for
• For infectious substances includes code Class
6.2 in mark
• Valid only if use correctly and as tested
Quantity limits for air transport
• UN 2814 & UN 2900 (Category A)
– Passenger aircraft 50ml/50g
– Cargo aircraft 4L/4Kg
• UN 3373 (Category B)
– All aircraft 4L/4Kg (1L per primary)
Excluding body parts, organs or whole bodies
Quantity limits for air transport
• UN 3245 (non-infectious GMMs)
– All aircraft 100ml/100g per primary
• UN 1845 (Dry ice)
– 200Kg
– or 2Kg in baggage if with non-dangerous
goods
Packaging
(PI #s for road/air)
• UN 2814 or UN 2900 (Category A)
– Packing Instruction 620/602
UN type-approved
• UN 3373 (Category B)
– Packing Instruction 650/650
Packaging
(PI #s for road/air)
• UN 3245 (non-infectious GMMs)
– Packing Instruction 904/913
• UN 1845 (dry ice)
– Packing Instruction ---/904
• Non dangerous goods - package safely
Refrigerated/cooled
• Ensure packaging maintains integrity
when ice melts or dissipates
• Must permit release of gas - ALWAYS
place dry ice outside secondary
• Use cold packs or similar for wet ice
• If Category A must ensure use UN
type-approved packaging properly
• Various options
Eg combination packs, overpacks, thermal
control units etc
Labels
• Delivery address
• Senders details
• Emergency contact details
– name and telephone number
• And as appropriate
– UN number and proper shipping name
– Hazard warning label
Category A
• Mark with UN number and proper
shipping name
Either
UN 2814 INFECTIOUS SUBSTANCE, AFFECTING
HUMANS
Or
UN 2900 INFECTIOUS SUBSTANCE, AFFECTING
ANIMALS ONLY
Category A
• And following hazard warning label
Category B
• Mark with proper shipping name
Either
DIAGNOSTIC SPECIMENS
Or
CLINICAL SPECIMENS
Category B
• And following mark
Note no biohazard sign or Class number
Genetically modified
micro-organisms (non-infectious)
• Mark with UN number and proper
shipping name
UN 3245 GENETICALLY MODIFIED MICROORGANSIMS
Non-infectious GMMs
• And following hazard warning label
Dry ice – transport by road
• Mark with words
DRY ICE
UN number and hazard warning label is
not required
Dry ice – transport by air
• Mark with UN number, proper shipping
name and net weight (Kg) of dry ice
UN 1845 DRY ICE ##Kg
Dry ice – transport by air
• And following hazard warning label
Packages containing liquids
• Must display the following Package
Orientation label on two opposite sides
Packages for cargo aircraft only
• Must display the following Cargo Aircraft
Only label
For example if package over quantity limit for
passenger aircraft
Paperwork/documentation
- within package
• Between secondary and outer
• Must include
–
–
–
–
Senders details
Delivery details
Emergency contact details
Description of the goods
• UN number and proper shipping name
– And for UN 2814 or UN 2900
• add technical name after proper shipping name
• itemised list of contents
Paperwork/documentation
- accompanying package
• For road transport
– dangerous goods declaration form
(not required for UN 3373)
• For air transport
– Air Waybill
– Shipper’s Declaration for Dangerous Goods
(not required for UN 3373)
Paperwork/documentation
• Detailed instructions on how to complete
the Air Waybill and Shippers Declaration
forms are included in Appendix 5 of
guidance
Sending dangerous goods by
courier
• Must meet classification, packaging and
labelling requirements
• Give full description of goods to courier
in advance
• Some couriers will not carry dangerous
goods or impose additional requirements
• It is illegal to conceal dangerous goods in
any packaging not showing appropriate
labels
Sending dangerous goods by post
• Must meet both legislative and Post
Office requirements
• Various prohibitions and restrictions
– HG 4 and certain specified HG 3 pathogens
prohibited
– dry ice prohibited
– maximum amount of infectious substances
restricted to 50g or 50ml
– only certain persons can send by post
– cannot send dangerous goods in international
service
Safebox?
• Purpose designed packaging produced by
Royal Mail
– for sending Category B materials
not suitable for Category A
– can post in pillar box
– complete ready to use kit
– £2.20 each including pre-paid postage
• Further details on Royal Mail’s website
www.royalmail.com and search for Safebox
– see interactive demo