Shipping Biological Materials



University of California

Shipment of Biological Materials Manual

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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

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 non-compliance 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.

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) 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.

2) 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 EH&S. Call EH&S at 459-5394 to schedule training or to ask questions regarding the shipment of biological materials and dry ice.

3) 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.

4) Classify and identify your materials for shipment. See Section IV.

5) Package, mark, and label your material(s) appropriately. See Section V.

6) Fill out the Shipper’s Declaration for Dangerous Goods form. See Section VI.

7) If you are shipping Select Agents, special regulations apply. Consult Section VII.

8) 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.

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.

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 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.

Figure 1 - Classification Guide for Diagnostic Specimens and Infectious Substances.

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1. 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.

2. 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 2 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.

3 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 2. [pic] |Figure 3. [pic] |Figure 4. [pic] |

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.

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. 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.

2. 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.

3. 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.

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.

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.

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.

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.

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. Shipper: Enter your full name, address and telephone number.

B. 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.

C. 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.

D. Shipment Type: Cross out “radioactive” to indicate you are shipping a non-radioactive substance.

E. Proper Shipping Name: Enter the proper shipping name exactly as it appears in Table 1.

F. Class or Division: Enter appropriate hazard class as found in Table 1.

G. UN or ID Number: Enter appropriate UN number as found in Table 1.

H. Packing Group: For dry ice, enter “III” in this column. Biological materials are not assigned packing groups.

I. Subsidiary Risk: Leave this column blank.

J. 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.”

K. Packing Instructions: Enter appropriate packing instruction number. Refer to Table 1.

L. Authorization: Leave this column blank.

M. 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.”

N. Signature and date.

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:



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.

Table 1. Summary of Shipping Information

|Shipment Type |Proper Shipping Name |UN Number |Hazard Class|Packing Group (PG) |Packing Instruction |Max. Net qty./pkg. for |Max. Net qty./pkg. for Cargo|

| | | | | |(PI) |Passenger Aircraft |Aircraft |

|Infectious substance, affecting only|Infectious substance, affecting animals |UN 2900 |6.2 |- |602 |50 ml or 50 g |4 L or 4 kg |

|animals (not humans) |(technical name) | | | | | | |

|Diagnostic or clinical specimen |Diagnostic specimens |UN 3373 |- |- |650 |4 L or 4 kg |4 L or 4 kg |

|Dry Ice |Dry Ice |UN 1845 |9 |III |904 |200 kg |200 kg |

| |or | | | | | | |

| |Carbon Dioxide, solid | | | | | | |

|Non-infectious, transducing |Genetically modified micro-organisms |UN 3245 |9 |- |913 |No limit |No limit |

|genetically modified micro-organisms| | | | | | | |

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.

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 |

|[] |

|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) |Livestock |

| |Arthropods inhabiting dung or of medical/veterinary significance |Moths |

| |Bees and bee related articles |Noxious weeds |

| |Biological materials containing animal material |Nursery stocks (including seeds) |

| |Butterflies |Parasitic plants |

| |Cell cultures of bovine or other livestock origins |Plant pathogens |

| |Cut flowers |Predators and parasitoids of arthropods |

| |Earthworms |Prohibited material for research purposes |

| |Endangered species |Rice and rice related articles |

| |Endangered species of wild fauna and flora |Seeds |

| |Entomopathogens |Snails and slugs |

| |Farm animals |Soil |

| |Foreign cotton and covers |Sugarcane products and by-products (including parts of the sugarcane |

| |Fruits and vegetables |plant) |

| |High consequence livestock pathogens and toxins |Tissue culture materials of bovine or other livestock origins |

| |Indian corn or maize, broomcorn and related plants |Weed biocontrol |

| |Infectious agents of livestock |Wildlife |

| |Khapra beetle products |Wood products |

| |Live arthropods for display or educational purpose | |

|CDC Etiologic Agent Import Permit Program |

|[] |

|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 |

|[] |

|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 |

|[] |

|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 |Ginseng |

| |Animals |Marine mammals |

| |Artificially propagated plants |Museum specimens |

| |Asian elephant ivory |Personal pet |

| |Biological samples |Plants |

| |Captive-born export |Raptors |

| |Circuses/traveling animal exhibitions |Trophies by taxidermist |

| |Goldenseal |Wildlife |

| |IMPORT |

| |African elephant |Marine mammals |

| |African elephant ivory |Museum specimens |

| |African leopard |Personal pet |

| |Argali |Plants |

| |Asian elephant ivory |Polar bears |

| |Biological samples |Scientific and zoological breeding or display |

| |Birds |Sport hunted trophy |

| |Bontebok |White rhinoceros |

| |Circuses/traveling animal exhibitions |Wildlife |

|U.S. Commerce Department – Bureau of Industry and Security (BIS) |

|[] |

|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 |Viruses |

| |Bartonella quintana (Rochalimea quintana, Rickettsia quintana) |Chikungunya virus |

| |Coxiella burnetii |Congo-Crimean haemorrhagic fever virus |

| |Rickettsia prowasecki |Dengue fever virus |

| |Rickettsia rickettsia |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 |

| |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) | |

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| |U.S. Commerce Department – Bureau of Industry and Security (BIS) |

| |[] |

|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 associated with the |Genetically modified organisms that contain nucleic acid sequences |

| |pathogenicity of controlled microorganisms. |associated with the pathogenicity of controlled microorganisms. |

| |Genetic elements that contain nucleic acid sequences coding for any |Genetically modified organisms that contain nucleic acid sequences coding|

| |controlled “toxins” or “sub-units of toxins.” |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 kahawae) |

| |Xanthomonas campestris pv. citri including strains referred to as |Cochliobolus miyabeanus (Helminthosporium oryzae) |

| |Xanthomonas campestris pv. citri types A,B,C,D,E or otherwise classified |Microcyclus ulei (Dothidella ulei) |

| |as Xanthomonas citri, Xanthomonas campestris pv. aurantifolia or |Puccinia graminis (Puccinia graminis f. sp. tritici) |

| |Xanthomonas campestris pv. Citrumelo. |Puccinia striiformis (Puccinia glumarum) |

| | |Magnaporthe grisea (pyricularia grisea/pyricularia oryzae) |

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.

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.

| |Appendix A – Microorganisms That Cannot Be Classified as Diagnostic Specimens* | |

|UN # and Proper Shipping Name |Microorganism |

|UN 2814 |Bacillus anthracis cultures |Highly pathogenic avian influenza virus cultures |

|Infectious substance affecting|Brucella abortus cultures |Japanese Encephalitis virus cultures |

|humans |Brucella melitensis cultures |Junin virus |

| |Brucella suis cultures |Kyasanur Forest disease virus |

| |Burkholderia mallei - Pseudomonas mallei - Glanders cultures |Lassa virus |

| |Burkholderia pseudomallei - Pseudomonas pseudomallei cultures |Machupo virus |

| |Chlamydia psittaci - avian strains cultures |Marburg virus |

| |Clostridium botulinum cultures |Monkeypox virus |

| |Coccidioides immitis cultures |Mycobacterium tuberculosis cultures |

| |Coxiella burnetii cultures |Nipah virus |

| |Crimean-Congo hemorrhagic fever virus |Omsk hemorrhagic fever virus |

| |Dengue virus cultures |Poliovirus cultures |

| |Eastern equine encephalitis virus cultures |Rabies virus |

| |Escherichia coli, verotoxigenic cultures |Rickettsia prowazekii cultures |

| |Ebola virus |Rickettsia rickettsia cultures |

| |Flexal virus |Rift Valley fever virus |

| |Francisella tularensis cultures |Russian spring-summer encephalitis virus cultures |

| |Guanarito virus |Sabia virus |

| |Hantaan virus |Shigella dysenteriae type 1 cultures |

| |Hantaviruses causing hantavirus pulmonary syndrome |Tick-borne encephalitis virus cultures |

| |Hendra virus |Variola virus |

| |Hepatitis B virus cultures |Venezuelan equine encephalitis virus |

| |Herpes B virus cultures |West Nile virus cultures |

| |Human immunodeficiency virus cultures |Yellow fever virus cultures |

| | |Yersinia pestis cultures |

|UN 2900 |African horse sickness virus |

|Infectious substance affecting|African swine fever virus |

|animals |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. |

Appendix B – Manufacturers of Certified Shipping Containers for Infectious Substances, Diagnostic Specimens & Dry Ice

|Air Sea Atlanta |All-Pak, Inc. |CARGOpak Corporation |

|1234 Logan Circle |Corporate One West |3215-A Wellington Court |

|Atlanta GA 30318 |1195 Washington Pike |Raleigh, NC 27615 |

|Phone: 404-351-8600 |Bridgeville, PA 15017 |Phone: 800-266-0652 |

| |Phone: 800-245-2283 | |

| | | |

|DG Supplies, Inc. |EXAKT Technologies, Inc. |HAZMATPAC, Inc |

|5 Boxal Drive |7416 N Broadway Ext., Suite E |5301 Polk St., Bldg 18 |

|Cranbury, NJ 08512 |Oklahoma City, OK 73116 |Houston, TX 77023 |

|Phone: 800-347-7879 |Phone: 800-923-9123 |Phone: 800-347-7879 |

| | | |

|Inmark, Inc. |JIT Certified, Inc. |Polyfoam Packers Corporation |

|220 Fisk Drive S.W. |1740 Fenpark Drive |2320 S. Foster Avenue |

|Atlanta, GA 30336-0309 |Fenton, MO 63026 |Wheeling, IL 60090 |

|Phone: 800-646-6275 |Phone: 800-962-8636 |Phone: 888-765-9362 |

| | | |

|SAF-T-PAK, Inc. |Source Packaging of New England, Inc. |Therapak Corporation |

|10807 - 182 Street Edmonton, Alberta, Canada, T5S|405 Kilvert St. |1440 Arrow Highway, Unit A |

|1J5 |Warwick, RI 02886 |Irwindale, California 91706 |

|Phone: 800-814-7484 |Phone: 800-200-0366 |Phone: 888-505-7377 |

| | | |

Appendix C – Shipper’s Declaration for Dangerous Goods Guide

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Appendix D – Example Shipper’s Declaration for Dangerous Goods [pic]

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 |

Appendix F – APHIS Plant Pathogens, HHS Select Infectious Agents & USDA High Consequence Livestock Pathogens/Toxins

|Viruses |Toxins |Exemptions |

|African horse sickness virus δ |Abrin β |The following agents or toxins are exempt if the aggregate amount under |

|African swine fever virus δ |Botulinum neurotoxins Υ |the control of a principal investigator does not, at any time, exceed: |

|Akabane virus δ |Clostridium perfringens epsilon toxin Υ |0.5 mg of botulinum neurotoxins |

|Avian influenza virus (highly pathogenic) δ |Conotoxins β |5 mg of Staphylococcal enterotoxins |

|Blue tongue virus (exotic) δ |Diacetoxyscirpenol β |100 mg of abrin, Clostridium perfringens epsilon toxin, conotoxin, ricin,|

|Camel pox virus δ |Ricin β |saxitoxin, shigatoxin, shiga-like ribosome inactivating protein, and |

|Cercopithecine herpesvirus 1 (Herpes B virus) β |Saxitoxin β |tetrodotoxin |

|Classical swine fever virus δ |Shigatoxin and Shiga-like ribosome inactivating proteins Υ |1,000 mg of diacetoxyscirpenol and T-2 toxin |

|Crimean-Congo haemorrhagic fever virus β |Staphylococcal enterotoxins Υ | |

|Eastern equine encephalitis virus Υ |Tetrodotoxin β |The following agents or toxins are also exempt: |

|Ebola viruses β |T– 2 toxin Υ |Any agent or toxin that is in its naturally occurring environment |

|Foot and mouth disease virus δ | |provided it has not been intentionally introduced, cultivated, collected,|

|Goat pox virus δ |Bacteria |or otherwise extracted from its natural source. |

|Japanese encephalitis virus δ |Bacillus anthracis Υ |Non-viable select agent organisms or nonfunctional toxins. |

|Lassa fever virus β |Botulinum neurotoxin producing species of Clostridium Υ |The vaccine strains of Junin virus (Candid #1), Rift Valley fever virus |

|Lumpy skin disease virus δ |Brucella abortus Υ |(MP-12), Venezuelan Equine encephalitis virus vaccine strain TC-83. |

|Malignant catarrhal fever virus δ |Brucella melitensis Υ | |

|Marburg virus β |Brucella suis Υ |The medical use of toxins for patient treatment is exempt. |

|Menangle virus δ |Burkholderia mallei Υ | |

|Monkeypox virus β |Burkholderia pseudomallei Υ |Genetic Elements, Recombinant Nucleic Acids, and Recombinant Organisms |

|Newcastle disease virus (VVND) δ |Coxiella burnetii Υ |Select agent viral nucleic acids (synthetic or naturally derived, |

|Nipah and Hendra complex viruses Υ |Cowdria ruminantium (Heartwater) δ |contiguous or fragmented, in host chromosomes or in expression vectors) |

|Peste des petits ruminants virus δ |Francisella tularensis Υ |that can encode infectious and/or replication competent forms of any of |

|Plum pox potyvirus α |Liberobacter africanus, Liberobacter asiaticus α |the select agent viruses. |

|Rift Valley fever virus Υ |Mycoplasma capricolu/M. F38/M. mycoides capri (contagious caprine |Nucleic acids (synthetic or naturally derived) that encode for the |

|Rinderpest virus δ |pleuropneumonia agent) δ |functional form(s) of any of the listed toxins if the nucleic acids: a) |

|Sheep pox virus δ |Mycoplasma mycoides mycoides (contagious bovine pleuropneumonia agent) δ|are in a vector or host chromosome; b) can be expressed in vivo or in |

|South American haemorrhagic fever viruses [(Junin, Machupo, Sabia, |Ralstonia solanacearum race 3 biovar 2 α |vitro; or c) are in a vector or host chromosome and can be expressed in |

|Flexal, Guanarito)] β |Rickettsia prowazekii β |vivo or in vitro. |

|Swine vesicular disease virus δ |Rickettsia rickettsii β |Listed viruses, bacteria, fungi, and toxins that have been genetically |

|Tick-borne encephalitis complex (flavi) viruses [Central European |Xanthomonas oryzae pv. oryzicola α |modified. |

|Tick-borne encephalitis, Far Eastern Tick-borne encephalitis (Russian |Xylella fastidiosa (citrus variegated chlorosis strain) α | |

|Spring and Summer encephalitis, Kyasanur Forest disease, Omsk Hemorrhagic|Yersinia pestis β |Other Restrictions |

|Fever)] β | |Experiments utilizing recombinant DNA that involve the deliberate |

|Variola major virus (Smallpox virus) and Variola minor (Alastrim) β |Fungi |transfer of a drug resistance trait to the listed agents that are not |

|Venezuelan equine encephalitis virus Υ |Coccidioides immitis Υ |known to acquire the trait naturally, if such acquisition could |

|Vesicular stomatitis virus (exotic) δ |Coccidioides posadasii β |compromise the use of the drug to control disease agents in humans, |

| |Peronosclerospora philippinensis α |veterinary medicine, or agriculture. |

|Prion |Phakopsora pachyrhizi α |Experiments involving the deliberate formation of recombinant DNA |

|Bovine spongiform encephalopathy agent δ |Sclerophthora rayssiae var zeae α |containing genes for the biosynthesis of listed toxins lethal for |

| |Synchytrium endobioticum α |vertebrates at an LD50 < 100 ng/kg body weight. |

| |

|α APHIS Plant Pathogen |β HHS Select Infectious Agent |δ USDA High Consequence Livestock Pathogen or Toxin |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.

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