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Guidelines for Shipping/Receiving Biological Materials

Table of Contents

Appendices

Appendix 1 - Materials Exempt From USDA/APHIS Import/Transport Permits
Appendix 2 - Center For Veterinary Biologics Notice No. 02-15
Appendix 3 - Application For Permit To Import/Transport Controlled Material Or Organisms Or Vectors
Appendix 4 - Sample Importation Notification Letter
Appendix 5 - Sample Interstate Movement Letter
Appendix 6 - Application for Permit to Import of Transport Agents or Vectors of Human Disease
Appendix 7 - Examples of Infectious Substances Included in Category A
Appendix 8 - Record of Transfer or Destruction of Select Agent
Appendix 9 - Summary of IATA (International Air Transport Association) Shipping Information
Appendix 10 - USDA/APHIS Courtesy Form Letter
Appendix 11 - USDA/APHIS Application for Courtesy Permit
Appendix 12 - How to Recognize and Handle a Suspicious Package or Envelope
Appendix 13 - Infectious Substance Classification Flow Chart
Appendix 14 - Shipper's Declaration of Dangerous Goods (Note: Form may be filled out electronically
but in order to save you must use Adobe Acrobat Professional.)
Appendix 15 - Transporting Infectious Substances Safely
Appendix 16 - Sample of a Customs Courtesy Letter

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I. Introduction

The shipping and receiving of biological materials is regulated by several government agencies. According to federal regulations:

" It is the responsibility of the shipper to ensure correct identification, classification, packaging, labeling, marking, and documentation for all shipments of infectious substances. In addition, the shipper must make advance arrangements with the recipient (consignee) and operator (carrier), including acquisition of any permits for the importation of infectious substances from foreign countries. Failure to comply with federal and international regulations can result in refusal of the shipment by the airline, penalties of fines, jail, or both. Hand carriage of infectious substances by air is strictly prohibited by law."

Applicable Transportation Regulations

49 CFR Parts 172 and 173-Department of Transportation Regulations for Infectious Substances and Regulated Medical Waste - DOT, see Transporting Infectious Substances Safely training at http://hazmat.dot.gov/training/Transporting_Infectious_Substances_Safely.pdf or Appendix 15
42 CFR Part 72 - Interstate Shipment of Etiologic Agents - CDC
IATA - Dangerous Goods Regulations
WHO - Guidelines for the Safe Transport of Infectious Substances and Diagnostic Specimens, 1997
Postal Service Hazardous Materials Domestic Mail Regulation

Before requesting biological material to be shipped to you:

Obtain any required permits, see Sections III & VI, and send copies to the shipper.
If shipment is from a foreign country be sure they are aware of U.S. shipping regulations and that they have the correct labels, send labels to the foreign shipper if needed.
Be sure you have current Institutional Biosafety Committee (IBC at http://www.research.umn.edu/ibc/) approval to work with the material if it requires Biosafety Level 2 or higher precautions or is a biologically-derived toxin.
Arrange to have someone present to receive the material when it arrives.

After receiving biological material:

Notify the Biosafety unit in Environmental Health & Safety to have Biosafety Level 2 or higher organisms and biologically-derived toxins added to the university's biological material inventory.

Before shipping biological material:

Request a copy of either IBC or Biological Safety Officer approval for pathogen possession/use from the receiver's institution, send a copy of the approval to DEHS.
Determine the material's classification, see Section IV and the Classification Flow Chart.
If the material is classified as a Category A or B Infectious Substance, or shipped on dry ice, or toxin you must either attend training or contact the DEHS HazMat Shipping Program for assistance, see Section II or http://www.dehs.umn.edu/hazwaste_shiphazwaste.htm.
Obtain the correct type of packaging and labels for the material classification.
If the receiver needs a permit, request a copy from them before shipping.
If shipment is going to another country see Section VI and include a customs courtesy letter.
Make arrangements for the receiver to be available to take possession of the package when it arrives.

The information provided in these guidelines is an overview and not meant to be comprehensive. It may be necessary to contact applicable government agencies for clarification and updates regarding permit requirements.

II. Training Requirements

If you only occasionally ship Category A or B Infectious Substances, or on dry ice, or toxins you may use Environmental Health and Safety's HazMat Shipping Program.

If you regularly ship Category A or B Infectious Substances (see Appendix 13 Infectious Substance Classification Flow Chart) or on dry ice or toxins as described in Section IV, you must receive initial and update training to fulfill the requirements of the U.S. Department of Transportation and the shipping companies. Shipping training must be updated every two years or more frequently if regulations change. Environmental Health and Safety offers a quarterly hazardous material shipping class.

These guidelines are meant to supplement the above training and are not a substitute for the hazardous material shipping class.

Shipping biological materials listed as excluded from dangerous goods regulations in Section IV does not require training.

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III. Permits to Receive Biological Materials

Federal permits are required to import/export disease causing agents for humans and animals, vectors for those agents, animal products, plants, plant products, and plant pests. Permits may also be required for domestic transport of some agents. The recipient of the material must obtain any required permits. If you are the shipper, request a copy of any applicable permits from the recipient.

The U.S. receiver (importer) is responsible for the package being sent to them from a foreign country. The receiver must assure that the foreign shipper has packed and labeled the material according to U.S. Public Health Service and the International Air Transport Association (IATA) regulations. The importer must send the proper shipping labels and a copy of their import permit to the shipper. Complying with foreign import regulations should prevent packages from being held at customs or denied entry. See Section VI for additional information.

Inquire to the proper government agency listed below for permit requirements and applications well before the material is needed as it may take several weeks to process a permit application.

A. USDA/APHIS Transport Permits

The USDA/APHIS (Animal and Plant Health Inspection Service) regulates transport of materials that could potentially harm U.S. agricultural products including livestock, poultry and crops. APHIS permits may be required for import, export, and interstate transport of animal or plant pathogens, pathogen vectors, animals, animal products, plants, plant products, and the introduction of genetically modified organisms into the environment.

Appendix D of the BMBL (Biosafety in Microbiological and Biomedical Laboratories), http://www.cdc.gov/od/ohs/biosfty/bmbl4/b4ad.htm lists agents that are prohibited for import or restricted by law or by the U.S. Department of Agriculture.

See Appendix 1 for a list of materials exempt from USDA/APHIS Import and transport permits. CDC regulations may apply to human and non-human primate samples excepted in Appendix 1, see Section B below.

USDA Import Guidelines For Products That Do Not Require An Import Permit

1110 Microbially Produced Materials:http://www.aphis.usda.gov/vs/ncie/imicro.html
1114 Recombinant Microbes and Their Products: http://www.aphis.usda.gov/vs/ncie/irecom.html

Animal Related

USDA/ APHIS permits are required for imports/ exports and inter-state transport of:

animal or plant pathogens including challenge material from the USDA, see Appendix 2
specimens reasonably believed to contain animal or plant pathogens*
vectors of animal or plant disease*
potentially hazardous animal or plant products

*USDA/APHIS regulation 9 CFR Animals and Animal Products Parts 94, 95, and 122 covers transport of organisms or vectors that can cause infectious diseases of animals. The regulation defines material requiring a permit as, "(d) Organisms. All cultures or collections of organisms or their derivatives, which may introduce or disseminate any contagious or infectious disease of animals (including poultry). (e) Vectors. All animals (including poultry) such as mice, pigeons, guinea pigs, rats, ferrets, rabbits, chickens, dogs, and the like, which have been treated or inoculated with organisms, or which are diseased or infected with any contagious, infectious, or communicable disease of animals or poultry or which have been exposed to any such disease." http://www.access.gpo.gov/nara/cfr/waisidx_03/9cfrv1_03.html.

An Import/Transport permit:

must be obtained by the intended receiver of the material before shipment is made
is good for one year and is amendable/renewable
application (VS Form 16-3) can be downloaded at: http://www.aphis.usda.gov/vs/ncie/pdf/vs16-3.pdf or see Appendix 3
form is for either foreign import or interstate transfer
requires 6 to 8 weeks for processing

To determine if the material you wish to transport requires a permit, visit the APHIS: National Center for Import and Export (NCIE) Website at http://www.aphis.usda.gov/vs/ncie/contacts.html.

NOTE: According to the USDA, "Generally, a USDA veterinary permit (VS-16-6) is needed for materials derived from animals or exposed to animal-source materials. Materials which require a permit include, animal tissues, blood, cells or cell lines of livestock or poultry origin, RNA/DNA extracts, hormones, enzymes, monoclonal antibodies for IN VIVO use in non-human species, certain polyclonal antibodies, antisera, bulk shipments of test kit reagents, and microorganisms including bacteria, viruses, protozoa, and fungi. Exceptions to this requirement are human and non-human primate tissues, serum, and blood ."

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Plant Related

USDA/APHIS regulation 7 CFR Part 330 Federal Plant Pest Regulations covers the transport of plant pests (http://www.access.gpo.gov/nara/cfr/waisidx_03/7cfrv5 03.html). For information on plant pest transport permits see http://www.aphis.usda.gov/ppq/permits/plantpest/. For information on plant and plant product transport permits see http://www.aphis.usda.gov/ppq/permits/plantproducts/.

The intended receiver of plants and plant pests must obtain a permit for transport before shipment is made. Allow 6 to 8 weeks for processing.

Examples of some permit applications are:

PPQ 526 Application for Permit to Move Live Plant Pests or Noxious Weeds
PPQ 586 Application for Permit to Transit Plants and/or Plant Products Into or Through the United States
PPQ 587(MD) Application for Permit to Import Plants or Plant Products
PPQ 588 Application for Permit to Import Plants or Plant Products for Experimental Purposes
Phytosanitary certificate: document required by many states and foreign countries see http://www.state.sd.us/doa/das/phyto.html for description

Contact APHIS for clarification of which permit is required, instructions on how to obtain permit applications, and to determine if any changes have been made to the initial regulation. APHIS National Center for Import/Export Products (301 734-3277) http://www.aphis.usda.gov/lpa/about/welcome.html

Genetically Modified Organisms (GMOs)

To determine if a permit is needed to import or transport a GMO, contact the APHIS Biotechnology permit branch via a letter of notification. See Appendix 4 & Appendix 5 for examples of Interstate Movement and Importation notification letters for genetically engineered plants and microorganisms.

B. Centers for Disease Control (CDC)

The Department of Health and Human Services, through the CDC, regulates the transport of biological materials that could cause illness in humans, including pathogens and biological toxins.

Foreign imports of the following materials require a Permit to Import or Transport Agents or Vectors of Human Disease:

any etiologic agent
any arthropod or other animal host or vector of human disease
any exotic living arthropod or other animal capable of being a host or vector of human disease

Domestic transport may or may not require a permit.

To determine if your shipment requires a permit:

call 404-498-2260
visit the CDC Web site at http://www.cdc.gov/od/eaipp/
Go to the online form to submit a permit application http://www.cdc.gov/od/ohs/biosfty/0753.pdf or see Appendix 6

Some microorganisms and cell lines purchased from ATCC require permits to be shipped domestically. For ATCC permit info see http://www.atcc.org/Order/permits.cfm.

C. Phytosanitary Certificate

A phytosanitary certificate is a document often required by many states and foreign countries for the import of nonprocessed, plant products.

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IV. Classification of Hazardous Material

Biological materials that fall under the Dangerous Goods Regulations for shipping by air are classified in one of four different groups:

Category A Infectious substances: Hazard Class 6.2
Category B Infectious Substance (previously called Diagnostic/Clinical specimens): Hazard Class 6.2
Toxins: Hazard Class 6.1
Some genetically modified organisms (GMOs) including microorganisms: Hazard Class 9

These classifications are used to select the proper shipping procedures, see Section V. Shipping Category A & B Infectious Agents, Toxins, and some GMOs require attending a training session, see Section II.

See Appendix 13 Infectious Substance Classification Flow chart to help determine if a material falls under Category A or B Infectious Substances.

NOTE: If the material is also classified as a Select Agent, additional regulations apply, see Section E below.

The following materials are not classified as dangerous goods and are not subject to IATA regulations:

Biological products which are manufactured and packaged in accordance with the requirements of appropriate national authorities and transported for the purposes of final packaging or distribution, and use for personal health care by medical professionals or individuals.
Biological products which are certified by the USDA, FDA, or other national authority for use in the prevention, diagnosis, or treatment of disease in humans or animals, or for development, experimental or investigational purposes related thereto. NOTE: If the product contains an infectious substance it must be shipped as Category A or B Infectious Substance.
Substances which do not contain infectious substances or substances which are unlikely to cause disease in humans or animals.
Substances containing micro-organisms which are non-pathogenic to humans or animals.
Patient specimens for which there is minimal likelihood that pathogens are present.

Note: Patient specimens are material collected directly from humans or animals, including, but not limited to, excreta, secreta, blood and its components, tissue and tissue fluid swabs, and body parts being transported for purpose such as research, diagnosis, investigational activities, disease treatment and prevention.

Note: In determining whether a patient specimen has a minimal likelihood that pathogens are present, an element of professional judgement is required to determine if a substance is exempt. That judgement should be based on the known medical history, symptoms and individual circumstances of the source, human or animal, and endemic local conditions. If there is any reason to suspect that the specimen contains a pathogen, it can not be shipped as exempt from Class 6.2 Hazardous Material.
Substances in a form that any present pathogens have been neutralized or inactivated such that they no longer pose a health risk.
Environmental samples (including food and water samples) which are not considered to pose a significant risk of infection.
Dried blood spots, collected by applying a drop of blood onto absorbent material, or faecal occult blood screening tests.
Material collected for transfusion or transplantation.
All human blood, human blood products and human cells must have a biohazard label (OSHA) on the sample on the primary containment but not on the outside of an "exempt human specimen".

Exempt substances do not require a Declaration of Dangerous Goods or hazardous material training. However, if the substance is shipped on dry ice the dangerous goods regulation for dry ice must be followed and training is still required.

USDA/APHIS permits may still be required even if IATA transportation regulations do not apply.

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A. Category A Infectious Substances

Infectious substances are materials which are known or are reasonably expected to contain pathogens. Pathogens are defined as microorganisms (bacteria, viruses, rickettsiae, parasites, fungi) and other agents, such as prions, which can cause disease in humans or animals.

tegory A Infectious Substances are agents which are transported in a form that, when exposure to it occurs, is capable of causing permanent disability or life threatening or fatal disease in otherwise healthy humans or animals. All material meeting this criteria must be shipped as Category A. See Appendix 7 for examples of Category A agents.

Note: Some of the materials on this list only need to be shipped as Category A if it is cultured. Cultures do not include patient samples. Patient samples are collected directly from the patient and are not propagated for diagnosis. When in doubt, ship as Category A

B. Category B Infectious Sustances (Previously Called Diagnostic/Clinical Specimens):

Category B Infectious Substances are biological materials that:

do not meet criteria for inclusion in Category A
are not exempt patient samples and are not included in the exemptions listed above

Category B substances are shipped under the proper shipping name: Biological Substance, Category B.

Any material listed in Appendix 7 cannot be shipped as Category B. This is a list of examples only and is not meant to include all materials forbidden as Category B. When in doubt, ship as Category A.

C. Non-infectious Exempt Patient Specimens

IATA (air transport) regulations allow for some patient specimens to be shipped as exempt from Dangerous Goods requirements. These regulations are adhered to by FedEx and can also be used for DHL/Airborne shipments.

Exempt patient specimens are those for which there is minimal likelihood that pathogens are present.

Note: Patient specimens are material collected directly from humans or animals, including, but not limited to, excreta, secreta, blood and its components, tissue and tissue fluid swabs, and body parts being transported for purpose such as research, diagnosis, investigational activities, disease treatment and prevention.

Note: In determining whether a patient specimen has a minimal likelihood that pathogens are present, an element of professional judgement is required to determine if a substance is exempt. That judgement should be based on the known medical history, symptoms and individual circumstances of the source, human or animal, and endemic local conditions. If there is any reason to suspect that the specimen contains a pathogen, it can not be shipped as exempt from Class 6.2 Hazardous Material.

Exempt patient specimens must be properly packaged, see Section VI C.

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D. Toxins

Toxins are material obtained from a plant, animal, fungal, or bacterial source that are toxic to humans or animals. Shipping of toxins falls under Hazardous Material regulations. If the toxin is contained in an infectious substance or if the toxin contains an infectious substance, it must be classified as an Infectious Substance, not a toxin. Packing Group (PG I, II, or III) criteria for toxins is based on severity of risk according to its LD₅₀.

E. Genetically Modified Organisms (GMOs)

Genetically modified micro-organisms (GMMOs) and genetically modified organisms (GMOs) are micro-organisms and organisms in which genetic material has been purposely altered through genetic engineering in a way that does not occur naturally. This includes laboratory rDNA.

Classifying GMOs for shipping:

If a GMO meets the definition of a Category A or B Infectious Substance it must be classified as such.
GMO which do not meet the definition of infectious substances 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 assigned to class 9 UN3245 if shipped by air.
GMOs not coming under the above two categories are not considered dangerous goods and have no shipping requirements.

See the Shipping GMO Fact Sheet to help determine which classification a GMO falls under.

Individual countries have strict regulations regarding GMOs. Be sure to become informed of the receiving country's regulations.

F. Select Agents

The federal government regulates the use, handling, and transport of certain biological materials considered to be potential bioterrorism agents. See the select agents list to determine if a material is considered a Select Agent.

Select Agents are classified as either Infectious Substances or Toxins. Follow IATA packing and labeling instructions according to its classification. Transport of Select Agents is subject to the following additional regulations; The Department of Health and Human Services' Regulation 42 Part 73, Possession, Use, and Transfer of Select Agents and Toxins; Final Rule, http://www.cdc.gov/od/sap/pdfs/42_cfr_73_final_rule.pdf, the USDA's Agricultural Bioterrorism Protection Act, and university policy.

Notify the university's Biosafety Officer at 626-6002 if you wish to ship, receive, or transfer any quantity of Select Agents. This includes on campus transfers. All infectious Select Agents and Select Agent toxins, in quantities above CDC exemption quantities, require DEHS and CDC or USDA approval prior to shipping. DEHS is responsible for tracking all transfers of Select Agents both on and off campus, documenting and reporting transfers to CDC or the USDA, verifying that transfers are only made between registered facilities, maintaining an accurate Select Agent inventory, and notifying CDC or USDA of suspicious activity or requests regarding the transfer of Select Agents.

Federally Regulated Quantities of Select Agents

CDC or USDA must approve all shipments of Select Agents between entities. Both the receiving and the shipping entity must have a current Select Agent Certificate of Registration. The receiving entity is responsible for initiating the approval process.

Steps to ship a Select Agent:

Contact DEHS to coordinate shipment and CDC/USDA approval with the receiving entity.
ll personnel packaging Select Agents for shipment must first attend the hazardous material shipping class and submit training documentation to DEHS. If shipments will not be made on a regular basis, you may use Environmental Health and Safety's HazMat Shipping Program.
After CDC/USDA approval has been received to ship the material, make arrangements to have an authorized individual from DEHS present during packaging of the material and to transport the package to DEHS to await pick-up.
Immediately update your inventory including the date sent and signature of the authorized individual who removed the material from storage. Send a copy to DEHS.
Notify DEHS any time a request is received for a Select Agent even if you do not agree to ship the material.

Steps to receive a Select Agent:

Verify that you have current IBC approval for use.
Call the Biosafety Officer (626-6002) to verify that the university's Certificate of registration includes your lab and the desired Select Agent material. If it does not, your lab and the material will have to be added to the certificate of registration before a request for shipment can be processed. If/when the lab is authorized for the Select Agent, DEHS will initiate a Report of Transfer Form EA 101 to be sent to the shipping entity.
After the shipping entity receives CDC/USDA approval for the transfer, DEHS will arrange for shipment. An authorized individual from DEHS will deliver the shipment to your lab.
Open the package in a biological safety cabinet, while the DEHS authorized individual is present, to examine the contents for damage. DEHS will notify the shipper and CDC/USDA that the package has arrived.
Update your inventory immediately including the date received, source of material, and any identifying characteristics. Sign the amended inventory log and send a copy to DEHS.

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Federally Exempt Quantities of Select Agent Toxins

Contact DEHS prior to shipping or receiving any quantity of Select Agent Toxins. Exempt quantities of Select Agent toxins do not require submission of Report of Transfer Form EA101 to CDC/USDA but are still tracked by DEHS in order to keep the university's biological material inventory up-to-date. Report to DEHS how much toxin is shipped, when it was shipped, and to whom it was shipped. Also report the disposal of all Select Agent Toxin quantities.

On Campus Transfer of Select Agents

Follow all transfer of biological material guidelines in Section VIII. In addition:

transfers can only be made between laboratories that are registered for that particular Select Agent
only authorized individuals can make transfers between labs
the receiving lab must have an authorized individual present to accept the material
document the transfer by submitting a Record of Transfer or Destruction of Select Agent to DEHS, see Appendix 8
both transferring and receiving labs must immediately update their inventory including the date of transfer and a signature of the authorized individual making the transfer.

V. Packing Instructions

The material presented in this section is meant as a supplement to the Hazardous Material Shipping class. It is not a substitute for the class. The following information is an overview, not comprehensive instructions.

Hazard Class designations and packing groups are used to determine the packing instructions that must be followed for shipping. See Appendix 9 for a summary of shipment types, proper shipping names, UN numbers, hazard class, and packing instruction numbers. For complete details on acceptable packaging, required labels, maximum quantity per package, and filling out the Shipper's Declaration for Dangerous Goods, attend a Hazardous Material Shipping class.

FedEx's Web site gives instructions on filling out their U.S. Airbill required for all shipments.

Packages displaying UN markings referred to in the following packing instructions meet the United Nations (UN) packaging specifications and performance testing.

A. Category A Infectious Substances: Packing Instruction 602

To ship category A substances you MUST have attended a Category A training session within the last two years. Infectious substances require a Shipper's Declaration for Dangerous Goods. FedEx's Web site, provides helpful information on filling out the Shipper's Declaration for Dangerous Goods.
Note: In order to save your filled out Declaration of Dangerous Goods you need to use Adobe Acrobat Professional.

Packaging material required for Packing Instruction 602 can be purchased from several venders including Label Master.

General Requirements

Shipping Training within the last two years

The Consignee section of the Shipper's Declaration for Dangerous Goods must include a name and phone number for the person responsible for the shipment.
Proper shipping names must be indicated on the outside of the package; for UN 2814 - Infectious Substance Affecting Humans and for UN 2900 - Infectious Substance Affecting Animals.
Technical names may be omitted from the proper shipping name on the outside of the package.
If the technical name of the pathogen is not known, you may omit the technical name on the Shipper's Declaration for Dangerous Goods and place "Suspected Category A infectious Substance" in parenthesis following the proper shipping name.
The Additional Handling Information box on the Shipper's Declaration for Dangerous Goods must include "Emergency Telephone Number 1-800-424-9300". (ChemTrec)
A MSDS sheet must be on file with ChemTrec prior to shipping
Enclose an itemized list of contents between the secondary packaging and the outer packaging.
If an overpack is used for dry ice, infectious substance markings need to go on the outer box along with the statement "Inner packages comply with prescribed specifications".

Inner Packaging Requirements

Primary receptacles must be watertight.
Secondary packaging must be watertight.
An itemized list of the contents enclosed between the secondary packaging and the outer packaging
Absorbent material must be placed between the primary receptacle(s) and secondary packaging and be of sufficient quantity to absorb the entire contents of the primary receptacle(s).

Outer Packaging Requirements

Must be rigid
Package must be at least four inches in the smallest overall external dimension.
Package must be properly labeled.
Package must pass required testing and be marked with UN marking for CLASS 6.2

A shipping checklist for Category A Dangerous Goods (must be non-radioactive) is available.

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B. Category B Infectious Sustances (Previously Called Diagnostic/Clinical Specimens): Packing Instruction 650

Shipping Training within the last two years is required.

2007 Shipping checklist for preparing shipments.

Shipments of Category B Infectious Substances do not require a a Dangerous Goods Declaration.

Packaging material required for Packing Instruction 650 can be purchased from several venders including Label Master.

Packaging must be of good quality, strong enough to withstand normal transport conditions including manual or mechanical handling, vibration, changes in temperature, humidity, or pressure. Packaging must have a:

a leak-proof primary receptacle not containing more than 1 liter or 4 kg
a leak-proof secondary package
a rigid outer package not containing more than 4 liters or 4 kg

The completed package must be capable of passing a drop test of of at least 1.2 meters. An itemized list of contents must be enclosed between the secondary packaging and the outer packaging. For complete details on package requirements see Packing Instruction 650.

New for 2006:

Outer package must have a diamond-shaped label with UN3373 in letters at least 6mm high and the proper shipping name "BIOLOGICAL SUBSTANCE, CATEGORY B" adjacent to the diamond-shaped label.
Outer package must have one side with a minimum of 100mm X100mm.
Include name, address, and telephone number of responsible party on either the air waybill or on the package.
Package may include 30ml or less of substances in Classes 3, 8,or 9 if required to maintain the viability of the sample, preserve the sample, or reduce the hazard of the sample. Remember, these packing instructions are for air shipments only.

C. Non-infectious Exempt Patient Specimens

Use a leak-proof primary receptacle.
When multiple fragile primary receptacles are placed in a single secondary package they must be either individually wrapped or otherwise seperated to prevent contact between them.
For liquid specimens, place sufficient absorbent material between the primary and secondary package to be able to absorb the entire volume.
Use a leak-proof secondary receptacle.
Use an outer package of adequate strength for its capacity, mass and intended use.
The outer package must have at least one surface with minimum dimensions of 100mm x 100mm. If the outer package is smaller, place it in a shipping envelope.
Mark the outer package "Exempt Human Specimen" or "Exempt Animal Specimen".
For the FedEx Airbill question "Does shipment contain dangerous goods?" check no.

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D. Toxins: Packing Instructions Vary

Shipping Training within the last two years is required.

Biologically-derived toxins which contain infectious substances or toxins that are contained in an infectious substance must be shipped as a Risk Class 6.2 Infectious Substances. All other biologically-derived toxins fall under Risk Class 6.1. Risk Class designations and packing groups are used to determine the packing instructions that must be followed for shipping. Packing Group criteria for toxins is based on severity of risk according to LD₅₀.

Very small amounts of toxins in Risk Class 6.1 may be shipped as "Dangerous Goods in Excepted Quantities." "Excepted Quantities" are excepted from the marking, labeling, and documentation requirements for shipping Dangerous Goods. No toxic label or Shipper's Declaration for Dangerous Goods are needed. On the FedEx waybill, check the box marked "Yes, does not require declaration of dangerous goods." If shipped by ground, the outer packaging must have the marking: "This package conforms to 49 CFR 173.4." If shipped by air, package must have a special handling label for "Excepted Quantities" indicating the hazard class and UN number.

Any quantity of inhalation toxins in Packing Group I may not follow "Excepted Quantities" procedures.

All "Dangerous Goods in Excepted Quantities" must be considered material that is permitted for shipping on passenger aircraft. "Dangerous Goods in Excepted Quantities" can not be transported in either checked or carry-on baggage or shipped via mail.

If shipping a quantity above the dangerous goods "Excepted Quantities", a shipper's Declaration For Dangerous Goods is required, toxic labels need to be attached, and package must be marked as meeting with UN performance requirements.

E. Genetically Modified Organisms: Packing Instruction 913

IATA regulated GMOs fall under Hazard Class 9, UN3245 and must follow Packing Instruction 913.

Hazardous Material shipping training is required.
Pack same as infectious materials (Packing Instruction 602) but package does not require testing.
The maximum quantity in a primary receptacle must not exceed 100ml or 100g.
Small quantities of regulated GMOs can be shipped under less stringent requirements, see the Shipping GMO Fact Sheet for instructions. Training is still required.

F. Dry Ice: Packing Instruction 904

Shipping Training within the last two years is required.

box must be able to release gas build-up
indicate the dry ice weight in kg on both the waybill and on the box
include the marking "Dry Ice, UN1845" on the box
place a Class 9 label on the box
2007 acceptance checklist for Dry Ice (if no Declarations of Dangerous Goods is required)

G. Liquid Nitrogen

Properly handled liquid nitrogen "dry shippers" can be transported without any additional regulations. Be sure that all the liquid nitrogen has been removed from the shipper before transport. Failure to do so can result in substantial fines. Contact DEHS for additional training on shipping biological materials with a "dry shipper". For further information, see University of Washington EH&S "Tips for Dry Shipping".

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H. Transporting Infectious Substances Safely

See Department of Transportation Transporting Infectious Substances Safely guide at Appendix 15

VI. International Shipment Regulations and Permits

The following agencies may require a permit for international shipments. Expect to need more preparation time to send or receive foreign shipments in order to process the required paperwork.

Taking care to comply with foreign import regulations should prevent packages from being held at customs or denied entry. As an extra precaution, you may wish to find out what carrier the shipper will use and what day and at what port your package is expected to arrive. Contact the U.S. Customs Office at that port and inform them that a package will be arriving for you and what the contents will be. Ask them to contact you immediately if there are any questions

A. USDA/APHIS

Section III covered USDA and CDC permits required to ship/receive biological material both within the U.S. and from a foreign country.

Be aware that Genetically Modified (Engineered) Organisms that are not controlled, or subject to regulations, may be held by customs because of the similarity of the organism to other organisms that are regulated. To prevent an international shipment from being stopped at the port of entry:

include a courtesy form letter in the shipment, see Appendix 10
as another option, application may be made for a Courtesy Permit (APHIS Form 2000) http://www.aphis.usda.gov/brs/pdf/2000.pdf or see Appendix 11. Indicate on the form that the data is being submitted as a request for a courtesy permit. Include a statement explaining why you believe the organism or product does not come within the definition of a regulated article. The application must be submitted at least 60 days prior to the time the courtesy permit is sought.

B. Department of Commerce

Bureau of Industry and Security published the final rule to amend the Export Administration Regulations (EAR) to expand export and re-export controls on certain biological agents and toxins that have been determined by the CDC, U.S. Department of Health and Human Services, APHIS, USDA, to have the potential to pose a severe threat to human, animal and plant life, as well as certain sectors of the U.S. economy (e.g., agriculture). For details see http://a257.g.akamaitech.net/7/257/2422/01jan20061800/edocket.access.gpo.gov/2006/E6-8995.htm. For information of export license see below.

The Department of Commerce may require a validated license for the export of:

infectious agents of human, plant and animal diseases
genetic material, and products which might be used for culture of large amounts of agents

Canada requires the recipient to have an import permit, see E. below.

This may be a long process and it may be difficult to find the necessary information, allow extra time to initiate foreign shipments of the above material. To determine if a license if required:

visit the Department of Commerce: Bureau of Industry and Security (BIS) website at http://www.bis.doc.gov/index.htm
submit an electronic inquiry request at https://www.bis.doc.gov/Forms/AskaCounselor.html (if there is an urgency to your request for information call 202-482-4811 instead of using the form)
to request an export licensing form visit https://www.bis.doc.gov/Forms/OrderingFormsOnLine.html

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C. U.S. Fish and Wildlife

A permit may be required by the U.S. Fish and Wildlife to export/import non-agricultural biological samples, including artificially propagated plants and endangered species. Call 1-800-770-0150 or go to http://www.fws.gov/permits/ to determine if your shipment needs a permit.

D. Food and Drug Administration (FDA)

The FDA controls most food and other products that enter the U.S. Foods (except for certain meats and poultry products), drugs (human, animal and biological), cosmetics, medical devices and radiation emitting devices, etc., offered for entry into the United States require a permit or registration. Go to http://www.fda.gov/ora/import/ to determine if your request for shipment of one of these products from another country is regulated.

E. Canadian Import Regulations

Shipments of human, animal, or plant pathogens to Canada will require a Canadian import permit. You will need to allow sufficient lead-time for the Canadian recipient to obtain the proper permits.

Packaging of shipments will need to comply with the Canadian Transport of Dangerous Goods Regulations. See the Transport Canada Web site for details, http://www.tc.gc.ca/acts regulations/GENERAL/T/tdg/repealed/tdg001/ part-i.html#Next%20Section.

VII. Receipt of Leaking, Damaged, or Suspicious Packages

A. Leaking or Damaged Package

Departments/laboratories that regularly receive shipments of biological materials should have a written procedure for the receipt of leaking or damaged packages.

If you receive a biological material package that is leaking or has broken containers inside, call the university's Biosafey Officer at 626-6002 to:

consult on clean-up procedures
determine if any outside agencies need to be notified
advise on disposal of the box and its contents

If any material is spilled on a person, remove contaminated clothing and shoes, flush the skin for 15 minutes, and seek medical assistance immediately.

While waiting for help to arrive:

do not touch or walk through spill area
isolate the spill or leak area
keep unauthorized personnel away
obtain identity of the substance(s) involved

B. Suspicious Package

See Appendix 12 or CDC Web site http://www.bt.cdc.gov/DocumentsApp/HAN50.pdf for guidelines on handling suspicious packages or envelopes.

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VIII. Ground Transport

A. Campus Transport Between Buildings or Labs

The following precautions should be taken when transporting infectious material or biological toxins between buildings or in public areas of buildings including elevators:

Provide your contact information: name, address, and phone on the outside of the package
Always use a leak-proof sealed primary container within a leak-proof sealed secondary container.
If the primary container is glass, the secondary container must be a sealed, rigid, non-breakable container.
Place sufficient absorbent material between the primary and secondary containers to absorb all the volume being transported.
Place a biohazard sticker on the container with the agent name and the name and phone number of an emergency contact.
If transporting on dry ice label the package "Dry Ice"
Leave the material with a known responsible individual in the receiving lab. Do not leave the material unattended or with an unknown individual.
Infectious material or biological toxins should not be transported on buses.

B. Ground Transport

The Department of Transportation (DOT) hazradous material shipping regulation has a "Material of Trade Exception" for ground transportation of patient samples and some infectious material via a private or contract carrier in a motor vehicle used exclusively to transport such materials. Materials shipped under this exception do not fall under other shipping requirements. The transported materisl must be properly packaged and secured against exposure or contamination. See below.

Materials that can be shipped under this exception are Division 6.2 material, other than a Category A infectious substance, contained in human or animal samples (including, but not limited to, secreta, excreta, blood and its components, tissue and tissue fluids, and body parts) that are being transported for research, diagnosis, investigational activities, or disease treatment/prevention, or is a biological product.

The material must be contained in a combination packaging. For liqulds, the inner packaging must be leakproof, and the outer packaging must contain sufficient absorbent material to absorb the entire contents of the inner packaging. For sharps, the inner packaging (sharps container) must be constructed of a rigid material resistant to punctures and securely closed to prevent leaks or punctures, and the outer packaging must be securely closed to prevent leaks or punctures. For solids, liquids, and sharps, the outer packaging must be strong, tight packaging securely closed and secured against movement, including relative motion between packages, within the vehicle on which it is being transported.

If the material you are transporting is a culture of Category B material, it must be packaged the same as for other Category B shipping:

rigid outer package of good quality, strong enough to withstand normal transport conditions
a leak-proof primary receptacle
leak-proof secondary package
absorbent material between primary and secondary container

The amount of Division 6.2 material in a combination packaging must conform to the following limitations: (A) one or more inner packagings, each of which may not contain more than 0.5 kg (1.1 lbs) or 0.5 L (17 ounces), and an outer packaging containing not more than 4 kg (8.8 lbs) or 4 L (1 gallon); or (B) A single inner packaging containing not more than 16 kg (35.2 lbs) or 16 L (4.2 gallons) in a single outer packaging.

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