University of California
Shipment of Biological Materials Manual
Edited and used with permission from
Andy Glode & David R. Gillum of
University of New Hampshire
Office of Environmental Health and Safety
Updated on
June 10, 2004
TABLE OF CONTENTS
I.
Introduction ................................................................................................................................................................... 3
II.
Training Requirements .................................................................................................................................................. 3
III.
Shipping Overview........................................................................................................................................................ 4
IV.
Shipment Types ............................................................................................................................................................. 4
A. Diagnostic Specimens ....................................................................................................................................................... 5
1. Packaging ..................................................................................................................................................................... 5
2. Labeling ....................................................................................................................................................................... 5
B. Infectious Substances ........................................................................................................................................................ 5
1. Packaging ..................................................................................................................................................................... 8
2. Labeling ....................................................................................................................................................................... 8
C. Biological Products ........................................................................................................................................................... 9
D. Genetically Modified Organisms and Microorganisms .................................................................................................... 9
V.
Packaging Biological Materials................................................................................................................................... 10
A. Triple Packaging ............................................................................................................................................................. 10
B. Other Packaging Requirements....................................................................................................................................... 11
VI.
Shipper’s Declaration for Dangerous Goods ............................................................................................................... 12
VII.
CDC Select Agents ..................................................................................................................................................... 15
VIII.
International Shipments .............................................................................................................................................. 15
A. Exporting from the United States ................................................................................................................................... 19
B. Importing into the United States ..................................................................................................................................... 19
Appendix A – Microorganisms That Cannot Be Classified as Diagnostic Specimens* ................................................................... 20
Appendix B – Manufacturers of Certified Shipping Containers for Infectious Substances, Diagnostic Specimens & Dry Ice ....... 21
Appendix C – Shipper’s Declaration for Dangerous Goods Guide .................................................................................................. 22
Appendix D – Example Shipper’s Declaration for Dangerous Goods ............................................................................................. 23
Appendix E – Intent to Ship Hazardous Materials ........................................................................................................................... 24
Appendix F – APHIS Plant Pathogens, HHS Select Infectious Agents
& USDA High Consequence Livestock Pathogens/Toxins ....................................................................................... 25
Appendix G – Additional HHS and USDA Select Agent/High Consequence Pathogen Exemptions .............................................. 26
--2--
I.
Introduction
The Environmental Health and Safety (EH&S) office has developed this manual to assist in the
shipment of biological materials and dry ice. This document includes information about how to
properly identify, classify, pack, mark, label and document your shipment. This manual also
describes the training requirements necessary to ship biological materials and dry ice.
Shipped biological specimens, infectious agents and other biological materials are regulated by
governmental and non-governmental, consensus development organizations. Penalties for noncompliance with the rules are significant and could result in the following fines:


Up to $250,000 and up to a year jail sentence for individuals.
Up to $500,000 per incident for organizations.
Several agencies regulate the shipment of biological materials including:





International Air Transport Association (IATA).
US Department of Transportation (DOT).
US Public Health Service (PHS).
Occupational Health and Safety Administration (OSHA).
Bureau of Industry and Security, U. S. Department of Commerce (BIS).
Infectious substances and other dangerous goods must always be transported according to the
appropriate regulations. Carrying dangerous goods by hand, for example in a vial in your pocket or
in luggage, is strictly prohibited. IATA/DOT regulations cover your checked luggage, materials
you carry on, or materials you carry in your pockets when you board an airplane. Persons who
violate IATA regulations are subject to fines and criminal prosecution.
IATA regulations are commonly encountered since they regulate materials transported by air and
are generally the most restrictive. For these reasons, this guide pays special attention to IATA
protocols.
II.
Training Requirements
Federal rules require that anyone wishing to ship biological materials or dry ice must first have
shipping training. If you are going to package biological materials or dry ice for shipment or fill
out a Shipper’s Declaration for Dangerous Goods you must follow the training certification
requirements outlined below.
1)
2)
Read this manual. This manual will provide familiarity with the general provisions
related to the regulations and detailed training in the requirements applicable to
shipping biological materials and dry ice.
Provide certification of EH&S Shipping Biological Materials course. Shipping
regulations change frequently so it is necessary to repeat training certification every
two years. Training sessions reviewing the material in this manual are available from
3)
III.
EH&S. Call EH&S at 459-5394 to schedule training or to ask questions regarding the
shipment of biological materials and dry ice.
Submit to the Export Shipping Manager an Intent to Ship Hazardous Materials form
(Appendix E). The Shipping Manager will review this form with you and, upon
successful completion, will certify you to ship only those materials that are listed on
your Intent form.
Shipping Overview
Follow these steps when shipping biological materials and dry ice.
1)
2)
3)
4)
5)
IV.
Classify and identify your materials for shipment. See Section IV.
Package, mark, and label your material(s) appropriately. See Section V.
Fill out the Shipper’s Declaration for Dangerous Goods form. See Section VI.
If you are shipping Select Agents, special regulations apply. Consult Section VII.
If you plan on importing or exporting biological materials, special regulations apply.
Consult Section VIII.
Shipment Types
For shipment purposes, biological materials are categorized into four classes:




Diagnostic specimens.
Infectious substances.
Biological products.
Genetically modified organisms and micro-organisms.
Read each material section carefully to determine how to classify a material. If you are shipping a
biological material that cannot cause disease, infectious substance regulations do not apply. Also,
Risk Group 1 microorganisms are not subject to biological shipping regulations. Note: All
specimens or packaging containing dry ice or liquid nitrogen must be shipped properly (see Other
Packaging Requirements). All samples preserved with flammable or toxic materials, such as
ethanol or formalin, must be shipped appropriately.
The regulations allow for a certain amount of professional judgment when classifying biological
materials for shipment. IATA does not apply the “Universal Precautions” definition in regard to
infectious materials (where all human blood, tissue, etc., is treated as potentially infectious). For
example, blood collected for routine screening is normally classified for shipment as a diagnostic
specimen. Also, specimens shipped to confirm a diagnosis of HIV (or any other RG-2 or RG-3)
may be classified as a diagnostic specimen. In many cases, the purpose of the shipment will
determine how the material will be classified, not the presence of pathogens. If you are still not
sure how to classify a material for shipment after reviewing the following sections, contact EH&S
at 459-5394.
-4-
A.
Diagnostic Specimens
Diagnostic specimens are any human or animal material including, but not limited to,
excreta, secreta, blood and its components, tissue and tissue fluids being transported for
diagnostic or investigational purposes, but excluding live infected animals. Diagnostic
specimens, including those taken from apparently healthy individuals may contain pathogens.
Diagnostic specimens must be assigned to UN 3373 unless the source patient or animal has
or may have a serious human or animal disease which can be readily transmitted from one
individual to another, directly or indirectly, and for which effective treatment and
preventative measures are not usually available, in which case they must be shipped as an
Infectious Substance and assigned to UN 2814 (Infectious substance, affecting humans) or
UN 2900 (Infectious substance, affecting animals).
Note: Assignments to UN 2814 or UN 2900 must be based on known medical history of
the patient or animal, endemic local conditions, symptoms of the patient or animal,
or professional judgment concerning individual circumstances of the patient or
animal.
A list of microorganisms that may not be classified as diagnostic specimens is provided in
Appendix A. For additional clarification on classification of diagnostic specimens, see Figure
1.
1. Packaging
The basic triple packaging concept applies to diagnostic specimens. Purchase packaging
for use with diagnostic specimens. Such packaging must comply with IATA Packing
Instruction 650. See Appendix B for a list of some packaging suppliers. Be sure to
specify if the shipment is a refrigerated sample (ice packs or dry ice).
For diagnostic specimens, the maximum quantity for primary receptacles is 500 mL or
500 g and outer packaging must not contain more than 4 L or 4 kg.
2. Labeling
The sender and recipient’s addresses must be printed and clearly displayed. If packed
with dry ice, a Class 9 label (Figure 2) must be placed on one side of the outer package. If
the package is shipped by air, the words “DIAGNOSTIC SPECIMENS” must appear on
the outer container.
B.
Infectious Substances
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, prions) or recombinant micro-organisms (hybrid or mutant) that are known
or reasonably expected to cause infectious disease in humans or animals. Substances or
-5-
microorganisms that are unlikely to cause human or animal disease are not included in
Division 6.2 and are not classified as Infectious Substances.
Note: Toxins from plant, animal or bacterial sources which do not contain any infectious
substances or toxins that are contained in substances which are not infectious
substances should be considered for classification in Division 6.1 and assignment to
UN 3172.
For additional clarification on classification of infectious substances, see Figure 1.
-6-
Figure 1 - Classification Guide for Diagnostic Specimens and Infectious Substances.
Material contains
pathogens?
NO
Material is unrestricted;
biological material shipping
regulations do not apply.
YES
Material contains
microoganisms likely to cause
human or animal disease 1 ?
NO
YES
Material contains or may contain
pathogens that cause highly
contagious, serious desease that
is difficult to treat 2 ?
YES
Classify as
Infectious Substance
NO
Shipping for diagnostic or
investigational purposes?
NO
YES
Classify as
Diagnostic Specimen
1.
2.
Risk Group 1 pathogens are unregulated; these are pathogens unlikely to cause human or animal disease with no or
very low individual or community risk.
These are pathogens that usually cause serious human or animal disease and that can be readily transmitted from
one individual to another, directly or indirectly, and for which effective treatment and preventative measure are not
usually available. Includes organisms listed in Appendix A.
1. Packaging
The triple packaging concept (explained in Section V) applies to infectious substances.
Purchase packaging approved for use with infectious substances. These packages must
comply with IATA Packing Instruction 602. See Appendix B for a list of packaging
suppliers. Make sure to specify if you are shipping a refrigerated sample (ice packs or dry
ice). The maximum quantity of infectious substance that can be shipped by air in one
package is 4 L or 4 kg. The maximum quantity that may be shipped via passenger aircraft is
50 mL or 50 g.
2. Labeling
The sender and recipient’s addresses must be printed and clearly displayed. The container
must be labeled with the name and telephone number of a person responsible for the
shipment. If packaged with dry ice, a Class 9 label (Figure 2) must be placed on one side of
the outer package. The container must be labeled with an infectious substance label (Figure
3). When shipping over 50 mL or 50 g of an infectious substance, you must also put a Cargo
Aircraft Label on the outer container (Figure 4).
When shipping infectious substances by air, you must make advanced arrangements with the
consignee (i.e., recipient) and the operator to ensure that the shipment can be transported and
delivered without delay. In the “Additional Handling Information” section of the Shipper’s
Declaration for Dangerous Goods, include the following statement:
“Prior arrangements as required by the IATA Dangerous
Goods Regulations 1.3.3.1 have been made.”
There are two proper shipping names for infectious substances:


Infectious substance, affecting humans (UN 2814); and
Infectious substance, affecting animals (UN 2900).
If you have any reason to believe the infectious material could affect humans you must ship
your material as UN 2814. Infectious materials that can affect humans and animals must be
shipped as UN 2814. Infectious materials that affect only animals must be shipped as UN
2900.
Figure 4.
Figure 2.
Figure 3.
C.
Biological Products
Biological products are derived from living organisms. These are manufactured and distributed
in accordance with the requirements of national governmental 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.
They include, but are not limited to, finished or unfinished products such as vaccines and
diagnostic products. Examples of biological products include certain viruses, therapeutic
serums, antitoxins, vaccines, blood, and blood products.
Biological products that have no or very low probability to produce disease are not subject to
biological shipping regulations. Biological products that meet the definition of an infectious
substance must be shipped as an infectious substance.
D.
Genetically Modified Organisms and Microorganisms
Genetically modified organisms (live animals, plants, etc) or microorganisms (bacteria, viruses,
etc) (both referred to as GMO’s) are characterized by the fact that genetic material has been
purposely altered through genetic engineering in a way that does not occur naturally. For
transport and shipment, they are divided into the following categories:
1.
2.
3.
GMO’s which meet the definition of infectious substance must be classified as
Division 6.2, packaged according to packing instruction 602 and shipped as
infectious substances, UN 2814 or UN 2900.
GMO’s which do not meet the definition of infectious substance but which are
capable of altering animals, plants or microbiological substances in a way which
is not normally the result of natural reproduction must be classified in Class 9,
packed according to packing instruction 913, and assigned to UN 3245.
GMO’s which do not meet the definition of infectious substance, are not capable
of altering the natural environment, and are not known or suspected to be
dangerous to humans or animals are not restricted for transportation.
Genetically modified organisms that are known or suspected to be dangerous to humans,
animals or the environment cannot be transported by air. Animals that contain, or are
contaminated with, genetically modified microorganisms or organisms that meet the definition
of an infectious substance cannot be shipped by air.
-9-
V.
Packaging Biological Materials
Potentially hazardous biological materials must be packaged to withstand leakage of contents, shocks,
temperature, pressure changes and other conditions that can occur during ordinary handling in
transportation. Packaging your material(s) appropriately is accomplished by purchasing certified
packaging. Refer to Appendix B for vendors that can supply certified packaging for biological
materials. When ordering, specify what category of material(s) you will be shipping: infectious
substances, diagnostic specimens, dry ice, ice packs, etc. Different categories have slightly different
packaging needs, but all follow the basic triple packaging requirements described below.
A.
Triple Packaging
Biological materials must be packaged according to the triple packaging principle depicted in
Figure 5. The three elements of triple packaging include: primary receptacle, leak-proof
secondary container, and durable outer container. Infectious substances, diagnostic specimens
and genetically modified micro-organisms must be packaged in this way, with slight variations.
Figure 5 - Packaging and labeling of biological materials.
- 10 -
The primary container holds the biological material; it must be leak-proof. It must be labeled
with the name of the contents. A leak-proof seal, such as a heat seal, skirted stopper or metal
crimp, is required. If the container has a threaded lid, it must be secured with waterproof tape.
Petri plates cannot be used as primary receptacles. Lyophilized substances can only be shipped
in flame sealed glass ampoules or rubber stopped glass vials with metal seals. Packaging
purchased for shipping infectious substances or diagnostic specimens usually does not include
the primary container.
The secondary container holds one or more primary containers, and must also be leak-proof.
This container must meet specific United Nations (UN) performance standards. Containers
purchased from commercial vendors are designed to meet the necessary standards. If you are
shipping any liquid, there must be enough absorbent material in the secondary container to
absorb all of the liquid in the primary receptacle(s). If multiple primary containers are used, they
must be wrapped to prevent contact between them so they do not break during transport.
The outer container must have one side that is at least 100 mm X 100 mm, in order for required
markings and labels to fit. The outer package must be of adequate strength for its capacity,
mass, and intended use. It must also be certified with a UN specification mark, when required.
An itemized list of package contents must be included between the outer and secondary
container. The outer package should be marked to identify hazardous contents, including the
proper shipping name, UN number and net quantity for each substance.
B.
Other Packaging Requirements
Overpacks. An overpack can be used to combine several triple packages into one large
package. This may be done to save freight charges when shipping multiple samples. Each triple
package inside the overpack must be properly marked and labeled. The outside of the overpack
must bear the same markings and labels as the triple packages within. If packed with dry ice, the
total net quantity of dry ice must be listed on the outer container. The overpack must also be
marked with the statement:
“Inner Packages Comply with Prescribed Specifications.”
Dry Ice. If a shipment includes dry ice, special packaging must be purchased. The outer
packaging must allow for the release of carbon dioxide gas when the solid sublimates. Dry ice
must be placed outside the secondary packaging. Interior supports must be provided to secure
the secondary container as the refrigerant sublimates. Dry ice is considered a miscellaneous
hazard (Class 9) by IATA. Packages containing dry ice must bear a Class 9 label and be marked
with the proper shipping name, UN number, and net quantity, (e.g., Dry Ice, UN1845, 3 kg).
Certified packages for dry ice most likely will be pre-labeled and marked. A Shipper’s
Declaration for Dangerous Goods is not required for shipments in which dry ice is the only
hazardous material. Dry ice is included on declarations for shipments that include other
hazardous materials such as infectious substances.
Liquid Nitrogen. Biological materials can be shipped refrigerated with liquid nitrogen in dry
shippers, which are insulated packages containing refrigerated liquid nitrogen fully absorbed in
a porous material. Special packing regulations apply to shipments containing nitrogen. Contact
EH&S if you need to ship materials with liquid nitrogen.
- 11 -
VI.
Shipper’s Declaration for Dangerous Goods
A Shipper’s Declaration for Dangerous Goods must be completed when shipping infectious
substances or genetically modified micro-organisms. A declaration is not required for shipments in
which dry ice is the only hazardous material. Dry ice should be listed on declarations for shipments
containing infectious substances or genetically modified microorganisms. A declaration is not
required if you are only shipping diagnostic specimens. Improperly completed declarations are the
most common cause of package refusal.
Refer to the Shipper’s Declaration for Dangerous Goods in Appendix C for an explanation of each
section:
A.
B.
C.
D.
E.
F.
G.
H.
I.
J.
K.
L.
M.
N.
Shipper: Enter your full name, address and telephone number.
Consignee: Enter full name and address of recipient. When shipping infectious substances,
include the text, “Person responsible for the shipment,” followed by the name and phone
number of the emergency contact.
Transport Details: Indicate here if your shipment is restricted to cargo aircraft only (if it is
more than 50 ml or 50 g of an infectious substance). Airport of departure and airport of
destination will be filled out by the carrier, leave blank.
Shipment Type: Cross out “radioactive” to indicate you are shipping a non-radioactive
substance.
Proper Shipping Name: Enter the proper shipping name exactly as it appears in Table 1.
Class or Division: Enter appropriate hazard class as found in Table 1.
UN or ID Number: Enter appropriate UN number as found in Table 1.
Packing Group: For dry ice, enter “III” in this column. Biological materials are not assigned
packing groups.
Subsidiary Risk: Leave this column blank.
Quantity and Type of Packaging: Enter the net quantity for each material here. Use only
metric units. At the bottom of this column, indicate the number and type of packages used
(usually, “All packed in one fibreboard box.”). Do not spell like “fiberboard.” If using an
overpack, indicate here with “Overpack Used.”
Packing Instructions: Enter appropriate packing instruction number. Refer to Table 1.
Authorization: Leave this column blank.
Additional Handling Instructions: Two statements are required in this section:
1. The statement “Emergency Contact: SHIPPERS NAME AND 24 HOUR PHONE
NUMBER. The individual listed in this space must be able to be reached 24 hours a day for
the entire time period the package is in transit. Once the package reaches its final
destination, the recipient should notify the shipper the package has arrived.
2. When shipping infectious substances, include the statement “Prior arrangements as required
by the IATA Dangerous Goods Regulations 1.3.3.1 have been made.”
Signature and date.
- 12 -
A blank Shipper’s Declaration for Dangerous Goods is available on-line in several formats from
most shipping providers. To view and download this form from the FedEx web site go to:
http://www.fedex.com/us/services/express/addservopt/dangerousgoods/declarationforms.html
Please note the following:




Declarations must be typewritten or computer-generated; handwritten declarations will not
be accepted.
Remember to sign each copy.
Always print at least four copies: provide three to the carrier and keep one for your records.
Regulations require that you must retain your copy for 375 days.
A sample declaration can be found in Appendix D. Contact the Export Shipping Manager with any
questions regarding the Shipper’s Declaration.
- 13 -
Table 1. Summary of Shipping Information
Proper Shipping Name
UN
Number
Hazard
Class
Packing
Group (PG)
Packing
Instruction (PI)
Max. Net qty./pkg. for
Passenger Aircraft
Max. Net qty./pkg.
for Cargo Aircraft
Infectious substance,
affecting humans and
possibly animals
Infectious substance, affecting
humans (technical name)
UN 2814
6.2
-
602
50 ml or 50 g
4 L or 4 kg
Infectious substance,
affecting only animals (not
humans)
Infectious substance, affecting
animals (technical name)
UN 2900
6.2
-
602
50 ml or 50 g
4 L or 4 kg
Diagnostic or clinical
specimen
Diagnostic specimens
UN 3373
-
-
650
4 L or 4 kg
4 L or 4 kg
Dry Ice
Dry Ice
or
Carbon Dioxide, solid
UN 1845
9
III
904
200 kg
200 kg
Non-infectious, transducing
genetically modified microorganisms
Genetically modified microorganisms
UN 3245
9
-
913
No limit
No limit
Shipment Type
VII. CDC Select Agents
The U.S. Department of Health and Human Services has developed a list of biological agents (see
Appendix F and Appendix G) that have the potential to pose a severe threat to public health. Special
regulations apply to the use and transfer of these materials, including registration with the
Institutional Biosafety Committee and the Centers for Disease Control and Prevention. If you are
planning to, or currently work with, any of the select agents listed below and have not registered,
contact the campus Biosafety Officer. Specific shipping restrictions apply to these agents which are
not discussed in this document.
VIII. International Shipments
ALL BIOLOGICAL MATERIALS BEING EXPORTED FROM THE COUNTRY NEED REVIEW AND
AUTHORIZATION BY THE EXPORT SHIPPING MANAGER.
Shipping and receiving animals and animal-derived materials, infectious or biohazardous agents,
biological toxins, and genetically modified organisms may require the approval of federal agencies,
both domestic and foreign. Regulations that govern the transfer of biological materials help to
minimize or eliminate the possible threats to public health and agriculture.
Packages shipped internationally generally require increased preparation time due to the additional
paperwork required for such packages. An import/export permit may be required when shipping
biological materials internationally. Check the following U.S. governmental agencies for permits and
additional information:
APHIS Agricultural Permits
[http://aphisweb.aphis.usda.gov/ppq/permits/]]
Telephone: 1-877-770-5990
APHIS permits are required to import or domestically transfer a plant pest, plant biological agent, or other material listed
below.
EXPORT/IMPORT
 Arthropods (insects and mites)
 Arthropods inhabiting dung or of medical/veterinary
significance
 Bees and bee related articles
 Biological materials containing animal material
 Butterflies
 Cell cultures of bovine or other livestock origins
 Cut flowers
 Earthworms
 Endangered species
 Endangered species of wild fauna and flora
 Entomopathogens
 Farm animals
 Foreign cotton and covers
 Fruits and vegetables
 High consequence livestock pathogens and toxins
 Indian corn or maize, broomcorn and related plants
 Infectious agents of livestock
 Khapra beetle products
 Live arthropods for display or educational purpose
- 15 -

















Livestock
Moths
Noxious weeds
Nursery stocks (including seeds)
Parasitic plants
Plant pathogens
Predators and parasitoids of arthropods
Prohibited material for research purposes
Rice and rice related articles
Seeds
Snails and slugs
Soil
Sugarcane products and by-products (including parts of the
sugarcane plant)
Tissue culture materials of bovine or other livestock origins
Weed biocontrol
Wildlife
Wood products
CDC Etiologic Agent Import Permit Program
[http://www.cdc.gov/od/ohs/biosfty/imprtper.htm]]
Telephone: 1-404-498-2260
CDC permits are required when shipping any etiologic agent known or suspected to cause disease in humans, unsterilized
specimens of human or animal tissues (including blood and other fluids), or biological vectors of infectious animals, bats,
insects, arthropods and snails.
ETIOLOGICAL AGENTS
 It is impractical to list all of the several hundred species of etiologic agents . In general, an import permit is needed for any
infectious substance known or suspected to cause disease in man.
BIOLOGICAL MATERIALS
 Unsterilized specimens of human and animal tissues (such as blood, body discharges, fluids, excretions or similar material)
containing an infectious agent requires a permit in order to be imported.
VECTORS
 Animals: Any animal known or suspected of being infected with an organism capable of causing disease transmissible to man may
require a CDC permit. Importation of live turtles of less than 4 inches in shell length and all nonhuman primates requires an
importation permit issued by the Division of Quarantine.
 Bats: All live bats require an import permit from the CDC and the U.S. Department of Interior, Fish and Wildlife Services.
 Insects or Arthropods: All live fleas, flies, lice, mites, mosquitoes, or ticks require a CDC import permit, regardless of infection
status. Permits are required for adult forms, as well as eggs, larvae, pupae, and nymph stages. Any other living insect or arthropod,
known or suspected of being infected with any disease transmissible to man requires a CDC import permit.
 Snails: Any snail species capable of transmitting a human pathogen require a permit from the Centers for Disease Control.
FDA Import Permits
[http://www.fda.gov/ora/import/]]
All food (except most meat and poultry), drugs, biologics, cosmetics, medical devices, and electronic products that emit
radiation require a permit or registration before importation into the United States.
Fish and Wildlife Service Permit Station
[http://international.fws.gov/permits/permits.html]]
Telephone: 1-800-770-0150
A permit may be required for transporting fish, wildlife, endangered species, or materials found in the list below.
EXPORT
 African elephant ivory
 Animals
 Artificially propagated plants
 Asian elephant ivory
 Biological samples
 Captive-born export
 Circuses/traveling animal exhibitions
 Goldenseal
IMPORT
 African elephant
 African elephant ivory
 African leopard
 Argali
 Asian elephant ivory
 Biological samples
 Birds
 Bontebok
 Circuses/traveling animal exhibitions
- 16 -








Ginseng
Marine mammals
Museum specimens
Personal pet
Plants
Raptors
Trophies by taxidermist
Wildlife









Marine mammals
Museum specimens
Personal pet
Plants
Polar bears
Scientific and zoological breeding or display
Sport hunted trophy
White rhinoceros
Wildlife
U.S. Commerce Department – Bureau of Industry and Security (BIS)
[http://www.bis.doc.gov/index.htm]]
A permit may be required from the Commerce Department, when exporting infectious agents of human, plant, and animal
diseases, including genetic material, and products which might be used for culture of large amounts of agents.
HUMAN PATHOGENS and TOXINS
Rickettsiae
 Bartonella quintana (Rochalimea quintana, Rickettsia
quintana)
 Coxiella burnetii
 Rickettsia prowasecki
 Rickettsia rickettsia
Bacteria
 Bacillus anthracis
 Brucella abortus
 Brucella melitensis
 Brucella suis
 Burkholderia mallei (Pseudomonas mallei)
 Burkholderia pseudomallei (Pseudomonas pseudomallei)
 Chlamydia psittaci
 Clostridium botulinum
 Francisella tularensis
 Salmonella typhi
 Shigella dysenteriae
 Vibrio cholerae
 Yersinia pestis
 Clostridium perfringens, epsilon toxin producing types
 Enterohaemorrhagic Excherichia coli, serotype O157 and
other verotoxin producing serotypes
Toxins
 Botulinum toxins
 Clostridium perfringens toxins
 Conotoxin
 Microcystin (Cyanginosin)
 Ricin
 Saxitoxin
 Shiga toxin
 Staphylococcus aureus toxins
 Tetrodotoxin
 Verotoxin
 Aflatoxins
 Abrin
 Cholera toxin
 Diacetoxyscirpenol toxin
 T-2 toxin
 HT-2 toxin
 Modeccin toxin
 Volkensin toxin
 Viscum Album Lectin 1 (Viscumin)
- 17 -
Viruses
 Chikungunya virus
 Congo-Crimean haemorrhagic fever virus
 Dengue fever virus
 Eastern equine encephalitis virus
 Ebola virus
 Hantaan virus
 Japanese encephalitis virus
 Junin virus
 Lassa fever virus
 Lymphocytic choriomeningitis virus
 Machupo virus
 Marburg virus
 Monkey pox virus
 Rift Valley fever virus
 Tick-borne encephalitis virus (Russian Spring-Summer
encephalitis virus)
 Variola virus
 Venezuelan equine encephalitis virus
 Western equine encephalitis virus
 White pox
 Yellow fever virus
 Kyasanur Forest virus
 Louping ill virus
 Murray Valley encephalitis virus
 Omsk haemorrhagic fever virus
 Oropouche virus
 Powassan virus
 Rocio virus
 St. Louis encephalitis virus
 Hendra virus (Equine morbillivirus)
 South American haemorrhagic fever (Savia, Flexal,
Guanarito)
 Pulmonary and renal syndrome haemorrhagic fever viruses
(Seoul, Dobrava, Puumala, Sin Nombre)
 Nipah virus
U.S. Commerce Department – Bureau of Industry and Security (BIS)
[http://www.bis.doc.gov/index.htm]]
A permit may be required from the Commerce Department, when exporting infectious agents of human, plant, and animal
diseases, including genetic material, and products which might be used for culture of large amounts of agents.
ANIMAL PATHOGENS and TOXINS
Viruses
Bacteria
 African swine fever virus
 Mycoplasma mycoides
 Avian influenza virus (some)
 Bluetongue virus
 Foot and mouth disease virus
 Goat pox virus
 Porcine herpes virus (Aujeszky’s disease)
 Swine fever virus (Hog cholera virus)
 Lyssa virua
 Newcastle disease virus
 Peste des petits ruminants virus
 Porcine enterovirus type 9 (swine vesicular disease virus)
 Rinderpest virus
 Sheep pox virus
 Teschen disease virus
 Vesicular stomatitis virus
 Lumpy skin disease virus
 African horse sickness virus
GENETIC ELEMENTS/GENETICALLY MODIFIED ORGANISMS
 Genetic elements that contain nucleic acid sequences
 Genetically modified organisms that contain nucleic acid
associated with the pathogenicity of controlled
sequences associated with the pathogenicity of controlled
microorganisms.
microorganisms.
 Genetic elements that contain nucleic acid sequences coding
 Genetically modified organisms that contain nucleic acid
for any controlled “toxins” or “sub-units of toxins.”
sequences coding for any controlled “toxins.”
 Technical Note: Genetic elements include, inter alia,
chromosomes, genomes, plasmids, transposons, and vectors,
whether genetically modified or unmodified.
PLANT PATHOGENS
Bacteria
Fungi
 Xanthomonas albilineans
 Colletotrichum coffeanum var. virulans (Colletotrichum
 Xanthomonas campestris pv. citri including strains referred to
kahawae)
as Xanthomonas campestris pv. citri types A,B,C,D,E or
 Cochliobolus miyabeanus (Helminthosporium oryzae)
otherwise classified as Xanthomonas citri, Xanthomonas
 Microcyclus ulei (Dothidella ulei)
campestris pv. aurantifolia or Xanthomonas campestris pv.
 Puccinia graminis (Puccinia graminis f. sp. tritici)
Citrumelo.
 Puccinia striiformis (Puccinia glumarum)
 Magnaporthe grisea (pyricularia grisea/pyricularia oryzae)
- 18 -
A. Exporting from the United States
Depending on the nature of the shipment, a U.S. export permit may be required when
sending your package. Additionally, an import permit may be required in the country where
the package is being shipped. If your shipment requires an export permit, it must be
completed and approved by the appropriate government agency prior to shipment.
Note: Packages may be opened and inspected when leaving the United States or at any time
by any inspection service provided by other countries. In order to assure that your package is
safely delivered to its intended destination, always consider the following:
1. If necessary, obtain an export permit from the appropriate governmental organization
prior to shipment.
2. Package and label the material according to the guidelines listed in this manual.
3. Consider including a courtesy letter with the shipment.
B. Importing into the United States
All shipments entering the United States are processed by the U.S. Bureau of Customs and
Border Protection. An import permit may be required to deliver the package even if a permit
is not required by the originating country. Check with the appropriate governmental
organization prior to shipment of the material.
Note: Packages may be opened and inspected upon entry into the United States. In order to
assure that your package is safely delivered to its intended destination, always consider the
following:
1. If necessary, obtain an import permit from the appropriate governmental organization
prior to shipment.
2. Package and label the material according to the guidelines listed in this manual.
3. Consider including a courtesy letter with the shipment.
The importer is legally responsible for assuring that foreign personnel package, label, and
ship the infectious materials according to USPHS and IATA regulations. Shipping labels
containing the universal biohazard symbol, the address of the importer, the permit number,
and the expiration date are also issued to the importer with the permit. The importer must
send the labels and one or more copies of the permit to the shipper. The permit and labels
inform the U.S. Customs and Border Protection and U.S. Division of Quarantine personnel
of the package contents.
- 19 -
Appendix A – Microorganisms That Cannot Be Classified as Diagnostic Specimens*
UN 2900
Infectious substance
affecting animals
UN 2814
Infectious substance affecting
humans
UN # and Proper
Shipping Name
Microorganism
-
-
-
Bacillus anthracis cultures
Brucella abortus cultures
Brucella melitensis cultures
Brucella suis cultures
Burkholderia mallei - Pseudomonas mallei Glanders cultures
Burkholderia pseudomallei - Pseudomonas
pseudomallei cultures
Chlamydia psittaci - avian strains cultures
Clostridium botulinum cultures
Coccidioides immitis cultures
Coxiella burnetii cultures
Crimean-Congo hemorrhagic fever virus
Dengue virus cultures
Eastern equine encephalitis virus cultures
Escherichia coli, verotoxigenic cultures
Ebola virus
Flexal virus
Francisella tularensis cultures
Guanarito virus
Hantaan virus
Hantaviruses causing hantavirus pulmonary
syndrome
Hendra virus
Hepatitis B virus cultures
Herpes B virus cultures
Human immunodeficiency virus cultures
-
African horse sickness virus
African swine fever virus
Avian paramyxovirus Type 1 - Newcastle disease virus
Bluetongue virus
Classical swine fever virus
Foot and mouth disease virus
Lumpy skin disease virus
Mycoplasma mycoides - Contagious bovine pleuropneumonia
Peste des petits ruminants virus
Rinderpest virus
Sheep pox virus
Goatpox virus
Swine vesicular disease virus
Vesicular stomatitis virus
-
* This list is not exhaustive.
- 20 -
-
Highly pathogenic avian influenza virus
cultures
Japanese Encephalitis virus cultures
Junin virus
Kyasanur Forest disease virus
Lassa virus
Machupo virus
Marburg virus
Monkeypox virus
Mycobacterium tuberculosis cultures
Nipah virus
Omsk hemorrhagic fever virus
Poliovirus cultures
Rabies virus
Rickettsia prowazekii cultures
Rickettsia rickettsia cultures
Rift Valley fever virus
Russian spring-summer encephalitis virus
cultures
Sabia virus
Shigella dysenteriae type 1 cultures
Tick-borne encephalitis virus cultures
Variola virus
Venezuelan equine encephalitis virus
West Nile virus cultures
Yellow fever virus cultures
Yersinia pestis cultures
Appendix B – Manufacturers of Certified Shipping Containers for Infectious Substances, Diagnostic
Specimens & Dry Ice
Air Sea Atlanta
1234 Logan Circle
Atlanta GA 30318
Phone: 404-351-8600
http://www.airseaatlanta.com
All-Pak, Inc.
Corporate One West
1195 Washington Pike
Bridgeville, PA 15017
Phone: 800-245-2283
http://www.all-pak.com
CARGOpak Corporation
3215-A Wellington Court
Raleigh, NC 27615
Phone: 800-266-0652
http://www.cargopak.com
DG Supplies, Inc.
5 Boxal Drive
Cranbury, NJ 08512
Phone: 800-347-7879
http://www.dgsupplies.com
EXAKT Technologies, Inc.
7416 N Broadway Ext., Suite
E
Oklahoma City, OK 73116
Phone: 800-923-9123
http://www.exaktpak.com
JIT Certified, Inc.
1740 Fenpark Drive
Fenton, MO 63026
Phone: 800-962-8636
http://www.jitcertifed.com
HAZMATPAC, Inc
5301 Polk St., Bldg 18
Houston, TX 77023
Phone: 800-347-7879
http://www.hazmatpac.com
Source Packaging of New
England, Inc.
405 Kilvert St.
Warwick, RI 02886
Phone: 800-200-0366
http://www.sourcepak.com
Therapak Corporation
1440 Arrow Highway, Unit A
Irwindale, California 91706
Phone: 888-505-7377
http://www.therapak.com
Inmark, Inc.
220 Fisk Drive S.W.
Atlanta, GA 30336-0309
Phone: 800-646-6275
http://www.inmarkinc.com
SAF-T-PAK, Inc.
10807 - 182 Street Edmonton,
Alberta, Canada, T5S 1J5
Phone: 800-814-7484
http://www.saftpak.com
- 21 -
Polyfoam Packers Corporation
2320 S. Foster Avenue
Wheeling, IL 60090
Phone: 888-765-9362
http://www.polyfoam.com
Appendix C
– Shipper’s Declaration for Dangerous Goods Guide
A
B
C
D
E
F
G
H
I
J
K
M
N
- 22 -
L
Appendix D – Example Shipper’s Declaration for Dangerous Goods
- 23 -
Appendix E – Intent to Ship Hazardous Materials
After reading the UC Shipment of Biological Materials and Dry Ice Manual, fill out this form to qualify to
ship biological materials. The Export Shipping Manager will review this completed form and upon
successful completion and demonstration of knowledge of applicable regulations you will be certified to
ship those materials designated on this form.
1.
What is the form and nature of the biological material?
2.
What is the quantity of material to be shipped?
3.
What was the source agent or organism the product was isolated from?
4.
Was the source organism genetically modified or altered?
5.
Is the organism a known human, animal, or plant pathogen or did it include any target genes for
pathogenesis?
6.
Could it be considered a toxin?
7.
Do we have any reason to suspect that exposure (inhalation, skin exposure, ingestion, etc.) to any of
the material being shipped could be harmful to an individual or the environment (other animals, etc.)?
8.
Are there any other hazardous materials (ethanol, formaldehyde, etc) included with this shipment
besides the biological material?
9.
Who exactly are you shipping the material to and where are they located?
10.
Are they affiliated with a University or research center?
11.
Do they plan to only use the material at their institution for research purposes or will the material be
distributed to any other location beyond its destination?
12.
Were you planning on shipping the material from the stock room, campus mail room or a couriers
(Fed Ex, UPS) drop off station?
13.
Will this shipment include dry ice?
14.
Have you purchased or ordered proper packaging material?
a. primary container
b. secondary container
c. labeling
15.
Is this a process that is likely to be repeated, with the same (or basically the same) materials,
packaging, recipient, etc.?
I understand the hazards associated with the materials noted above. Also, I understand the shipping
requirements for those materials, as outlined in this manual.
Print name:
Signature:
Date:
Please return, in campus mail, to Export Shipping Manager
- 24 -
Appendix F – APHIS Plant Pathogens, HHS Select Infectious Agents & USDA High Consequence Livestock Pathogens/Toxins
Viruses
Toxins
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
14.
15.
16.
17.
18.
19.
20.
21.
22.
23.
24.
25.
26.
27.
28.
1)
2)
3)
4)
5)
6)
7)
8)
African horse sickness virus δ
African swine fever virus δ
Akabane virus δ
Avian influenza virus (highly pathogenic) δ
Blue tongue virus (exotic) δ
Camel pox virus δ
Cercopithecine herpesvirus 1 (Herpes B virus) β
Classical swine fever virus δ
Crimean-Congo haemorrhagic fever virus β
Eastern equine encephalitis virus Υ
Ebola viruses β
Foot and mouth disease virus δ
Goat pox virus δ
Japanese encephalitis virus δ
Lassa fever virus β
Lumpy skin disease virus δ
Malignant catarrhal fever virus δ
Marburg virus β
Menangle virus δ
Monkeypox virus β
Newcastle disease virus (VVND) δ
Nipah and Hendra complex viruses Υ
Peste des petits ruminants virus δ
Plum pox potyvirus α
Rift Valley fever virus Υ
Rinderpest virus δ
Sheep pox virus δ
South American haemorrhagic fever viruses [(Junin,
Machupo, Sabia, Flexal, Guanarito)] β
29. Swine vesicular disease virus δ
30. Tick-borne encephalitis complex (flavi) viruses [Central
European Tick-borne encephalitis, Far Eastern Tick-borne
encephalitis (Russian Spring and Summer encephalitis,
Kyasanur Forest disease, Omsk Hemorrhagic Fever)] β
31. Variola major virus (Smallpox virus) and Variola minor
(Alastrim) β
32. Venezuelan equine encephalitis virus Υ
33. Vesicular stomatitis virus (exotic) δ
Prion
1. Bovine spongiform encephalopathy agent δ
α
APHIS Plant Pathogen
β
HHS Select Infectious Agent
δ
9)
10)
11)
Exemptions
Abrin β
Botulinum neurotoxins Υ
Clostridium perfringens epsilon toxin Υ
Conotoxins β
Diacetoxyscirpenol β
Ricin β
Saxitoxin β
Shigatoxin and Shiga-like ribosome inactivating proteins
Staphylococcal enterotoxins Υ
Tetrodotoxin β
T– 2 toxin Υ
Bacteria
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
14.
15.
16.
17.
18.
19.
Υ
Bacillus anthracis Υ
Botulinum neurotoxin producing species of Clostridium Υ
Brucella abortus Υ
Brucella melitensis Υ
Brucella suis Υ
Burkholderia mallei Υ
Burkholderia pseudomallei Υ
Coxiella burnetii Υ
Cowdria ruminantium (Heartwater) δ
Francisella tularensis Υ
Liberobacter africanus, Liberobacter asiaticus α
Mycoplasma capricolu/M. F38/M. mycoides capri
(contagious caprine pleuropneumonia agent) δ
Mycoplasma mycoides mycoides (contagious bovine
pleuropneumonia agent) δ
Ralstonia solanacearum race 3 biovar 2 α
Rickettsia prowazekii β
Rickettsia rickettsii β
Xanthomonas oryzae pv. oryzicola α
Xylella fastidiosa (citrus variegated chlorosis strain) α
Yersinia pestis β
The following agents or toxins are exempt if the aggregate
amount under the control of a principal investigator does not, at
any time, exceed:
 0.5 mg of botulinum neurotoxins
 5 mg of Staphylococcal enterotoxins
 100 mg of abrin, Clostridium perfringens epsilon toxin,
conotoxin, ricin, saxitoxin, shigatoxin, shiga-like ribosome
inactivating protein, and tetrodotoxin
 1,000 mg of diacetoxyscirpenol and T-2 toxin
The following agents or toxins are also exempt:
 Any agent or toxin that is in its naturally occurring
environment provided it has not been intentionally
introduced, cultivated, collected, or otherwise extracted from
its natural source.
 Non-viable select agent organisms or nonfunctional toxins.
 The vaccine strains of Junin virus (Candid #1), Rift Valley
fever virus (MP-12), Venezuelan Equine encephalitis virus
vaccine strain TC-83.
The medical use of toxins for patient treatment is exempt.
Genetic Elements, Recombinant Nucleic Acids, and
Recombinant Organisms
1.
2.
3.
Select agent viral nucleic acids (synthetic or naturally
derived, contiguous or fragmented, in host chromosomes or
in expression vectors) that can encode infectious and/or
replication competent forms of any of the select agent
viruses.
Nucleic acids (synthetic or naturally derived) that encode
for the functional form(s) of any of the listed toxins if the
nucleic acids: a) are in a vector or host chromosome; b) can
be expressed in vivo or in vitro; or c) are in a vector or host
chromosome and can be expressed in vivo or in vitro.
Listed viruses, bacteria, fungi, and toxins that have been
genetically modified.
Other Restrictions
Fungi
1.
2.
3.
4.
5.
6.
1. Experiments utilizing recombinant DNA that involve the
deliberate transfer of a drug resistance trait to the listed agents
that are not known to acquire the trait naturally, if such
acquisition could compromise the use of the drug to control
disease agents in humans, veterinary medicine, or agriculture.
2. Experiments involving the deliberate formation of
recombinant DNA containing genes for the biosynthesis of
listed toxins lethal for vertebrates at an LD50 < 100 ng/kg
body weight.
Υ
Coccidioides immitis
Coccidioides posadasii β
Peronosclerospora philippinensis
Phakopsora pachyrhizi α
Sclerophthora rayssiae var zeae α
Synchytrium endobioticum α
α
USDA High Consequence Livestock Pathogen or Toxin
- 25 -
Υ
USDA-HHS Overlap Agent
Appendix G – Additional HHS and USDA Select Agent/High Consequence Pathogen Exemptions
Attenuated strains of HHS select agents and toxins excluded:




Coccidioides posadasii ∆chs5 strain.
Conotoxins specifically excluded are: the class of sodium channel antagonist μ-conotoxins, including GIIIA;
the class of calcium channel antagonist ω-conotoxins, including GVIA, GVII, MVIIA, MVIIC, and their
analogs or synthetic derivatives; the class of NMDA-antagonist conantokins, including con-G, con-R, con-T
and their analogs or synthetic derivatives; and the putative neurotensin agonist, contulakin-G and its
synthetic derivatives.
Yersinia pestis strains which are Pgm- due to a deletion of a 102-kb region of the chromosome termed the
pgm locus (i.e., ∆pgm). Examples are Y. pestis strain E.V. or various substrains such as EV 76.
Yersinia pestis strains (e.g., Tjiwidej S and CDC A1122) devoid of the 75 kb low-calcium response (Lcr)
virulence plasmid.
Attenuated strains of Overlap select agents and toxins excluded:









Bacillus anthracis strains devoid of both plasmids pX01 and pX02.
Bacillus anthracis strains devoid of the plasmid pX02 (e.g., Bacillus anthracis Sterne, pX01+pX02-).
Brucella abortus Strain 19.
Brucella abortus strain RB51 (vaccine strain).
Coxiella burnetii Phase II, Nine Mile Strain, plaque purified clone 4.
Francisella tularensis subspecies novicida (also referred to as Francisella novicida) strain, Utah 112 (ATCC
15482).
Francisella tularensis subspecies holartica LVS (live vaccine strain; includes NDBR 101 lots, TSI-GSD
lots, and ATCC 29684).
Francisella tularensis ATCC 6223 (also known as strain B38).
Venezuelan Equine Encephalitis (VEE) virus vaccine candidate strain V3526.
Attenuated strains of USDA select biological agents and toxins excluded:

Japanese encephalitis virus SA14-14-2 strain.
- 26 -