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Shipping Infectious Substances by Air

The transportation of biological materials is highly regulated by the U.S. Public Health Service, the Department of Transportation (DOT) and the International Air Transport Association (IATA).

FedEx will not accept a Dangerous Goods Declaration created using this template (all other carriers will). You must use a Dangerous Goods Declaration created using specific FedEx software. Contact Ericka E. Pearce at eep3p@virginia.edu or 982-4911 for more information on completing Dangerous Goods Declarations for FedEx shipments.

  • If you are shipping Category A infectious substances, you may now list Chemtrec as an emergency contact on the Shippers Declaration (this is in addition to the name and telephone number of the Responsible Person).
  • An MSDS and a submission form (pdf or word) of the material MUST be submitted to Adam Peters at app5a@virginia.edu prior to shipping.
  • The name Chemtrec and number to be listed on the Shippers Declaration (under additional handling information) is 1-800-424-9300.

You will find the following on this page:

Training Requirements

University personnel who ship infectious substances including patient (clinical) specimens, human-derived research materials, infectious microorganisms, certain genetically-modified organisms, etc. must complete a training program prior to shipping Infectious or biological substances. To satisfy the training program requirement, EHS offers Shipping Infectious Substances Training (IATA/DOT) online. Those who complete training must retain a training certificate (provided by EHS) confirming that they passed the final exam. Shipping Infectious Substances Training (IATA/DOT) is valid for two years.

Shipping Infectious Substances Training (IATA/DOT), click here to start online module

In addition to the online Shipping Infectious Substances Training (IATA/DOT), EHS will provide in-person training for those groups (minimum of 10) who request it. Please contact Ericka E. Pearce at eep3p@virginia.edu for more information.

Contact EHS Biosafety

If you are shipping or exporting equipment, infectious substances, clinical specimens, or other hazardous materials we can provide guidance and assistance concerning the permitting, licensing, packaging and shipping of these materials. Researchers must be cognizant of relevant import, export, or transfer requirements (i.e. MTA) that involve their research materials.

For more information BEFORE you transport or ship research materials contact Ericka E. Pearce at eep3p@virginia.edu or 982-4911.

Frequently Asked Questions (FAQ)

What is Regulated?

  • In general, an infectious substance is any material known to contain or can reasonably expected to contain pathogens (e.g., bacteria, viruses, prions, parasites, fungi, etc). DOT Hazardous Material Regulations (HMR) found in 49 CFR Parts 171-180 define infectious substances as: Infectious substances known or are reasonably expected to contain pathogens (e.g., bacteria, viruses, rickettsiae, parasites, fungi, prions). 
  • Infectious Substance, Category A: A specimen that is transported in a form that is capable of causing permanent disability, life threatening condition or fatal disease to humans or animals when exposure to it occurs, is considered an Infectious Substance, Category A, specimen. For a complete list, refer to IATA Dangerous Goods Regulations, 49th Edition, 2008.
    • You may list Chemtrec as an emergency contact on the Shippers Declaration (this is in addition to the name and telephone number of the Responsible Person).
    • An MSDS and a submission form (pdf or word) of the material MUST be submitted to Adam Peters at app5a@virginia.edu prior to shipping.
    • The name Chemtrec and number to be listed on the Shippers Declaration (under additional handling information) is 1-800-424-9300.
  • Infectious Substance, Category B: An infectious Substance which does not meet the criteria for inclusion in Category A. This category also may include:
    • Human or Animal material collected directly from humans or animals and transported for research, diagnosis, investigational activities, or disease treatment or prevention. Patient specimens may include excreta, secreta, blood and its components, tissue and tissue swabs, body parts, and specimens in transport media (e.g. transwabs, culture media, and blood culture bottles). (Note: Cultures are not included in this definition, only inoculated media)
    • Biological Products (FDA regulated finished unfinished products, e.g., vaccines)
    • Genetically modified microorganisms and organisms
    • Infected animals
    • Exemptions: Exempt Patient Specimen and Exempt Animal Specimen are those clinical samples for which there is minimal likelihood that pathogens are present are not subject to the regulations. However, the shipments must be prepared using triple packaging. An Exempt Specimen Guide is provided here (pdf or word).

What is not Regulated?

  • Substances which do not contain infectious substances or unlikely to cause disease
  • Substances containing non-pathogenic microorganisms
  • Substances in which pathogens have been neutralized or inactivated and no longer pose a health risk
  • Environmental samples (e.g. food, water) which do not pose a significant risk of infection
  • Dried blood spots (faecal occult)
  • Blood products to be used for transfusion or tissues and organs for transplantation

Fines and Penalties

An individual (faculty members, staff and students) who violates the requirements for shipping or transporting hazardous materials is liable for up to $250,000 in fines and imprisonment for up to 5 years. It is therefore critical that you alert your faculty and everyone in your laboratories to (a) the need to follow hazmat shipping regulations and (b) to formally inform any contractors (e.g. movers or installers) entering a laboratory of the hazards in the lab.

Biohazardous waste that falls under the state regulatory authority is termed "Regulated Medical Waste" and encompasses all the wastes that are generated from work with infectious agents and human derived materials. Regulated Medical Waste (RMW) is regulated by the Virginia department of Environmental Quality (VDEQ).

 

Shipping Hazardous Materials

Contact List for Guidance on Shipping Hazardous Materials (Dangerous Goods)

Shipment of Hazardous Materials (Dangerous Goods) is highly regulated. Environmental Health & Safety (EHS) is available to assist faculty, staff, and students who make hazardous material shipments. EHS can provide training, guidance and support services that will help ensure hazardous material shipments arrive at their destination in the safest way possible.

Hazardous Materials (Dangerous Goods) EHS Contact Person Can be shipped by?
Hazardous Chemicals1 Adam Peters
email, 434-982-4911
EHS personnel only
Dry Ice only1
(shipping guide) (printable labels doc or pdf)4
Adam Peters
email, 434-982-4911
EHS personnel upon request
or
EHS trained shipper
Radiological materials1 Mike Cohen
email, 434-982-4911
or
Trevor Thomas
email, 434-982-4911
EHS personnel only

Infectious Substances or other biological materials2,3
(printable labels doc or pdf)4

For more information see:
Shipping Infectious Substances by Air
Transporting Infectious Substances by Ground

Ericka Pearce
email, 434-982-4911
Trained shipper in lab or department
Online training is available, here.

1All shipments of chemical or radiological materials MUST be shipped by EHS personnel. Additionally, unregulated materials on dry ice will also be shipped by EHS upon request. Materials will be picked up and taken back to the EHS office where they will be properly packaged, marked, labeled and documented for shipment. The lab will provide a PTAO to EHS to pay for shipping costs, which will be recovered from the lab of origin via cost transfer (a FedEx account number will be requested for radiological packages).

2Shipments of Infectious Substances (including those on dry ice) will continue to be the responsibility of the certified shipper and personnel must complete training every 2 years. Online training is available, here.

3Biologicals Checklists - FedEx Biologicals Worksheet (doc or pdf) and FedEx Pointers on Shipping Biologicals can provide assistance in determining how to prepare a shipment of biologicals. Note that you MUST still complete training and be certified by UVa before offering any Dangerous Good for Shipment.

4You may print and affix to your shipment using packing tape.

International Shipments

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.

  • An import/export permit may be required when shipping biological materials internationally.
  • Whether you are exporting or importing, every shipment needs an invoice so customs will be able to assess what you are shipping and the value.

Most International Shipping companies may assist with customs regulatory documents (Note: These are separate from IATA requirements and are the shippers responsibility to obtain). FedEx provides a template for a Commercial Invoice. You may also find useful information in the FedEx International Reference Guide.

Importing Research Materials

In addition to the IATA Dangerous Goods Regulations, many import and/or customs regulations may apply to materials your lab is importing. Principal Investigators are required to apply for and maintain valid permits when importing regulated materials. Contact EHS Biosafety for assistance in acquiring any necessary permits. It is advised to allow at least 4-6 weeks to obtain either a USDA or CDC permits before making arrangements to receive shipments.

Import Permits

CDC Permit to Import or Transport Agents or Vectors of Human Disease

CDC permits are required when shipping any infectious agent known or suspected to cause disease in humans, unsterilized specimens of human or animal tissues (including blood and other fluids, unfixed tissues), or biological vectors of infectious animals, bats, insects, arthropods and snails.

View the CDC's Etiologic Agent Import Permit Program here.

Contact information:
Centers for Disease Control and Prevention
Mailstop A-46
1600 Clifton Road,
Atlanta, GA 30333
PH: 404-718-2077
FAX: 404-718-2093
E-mail: importpermit@cdc.gov
URL: http://www.cdc.gov/od/eaipp/

USDA/APHIS Veterinary Permit (16-6)

May be needed for the importation of materials derived from animals or exposed to animal-source materials. APHIS permits are required to import or domestically transfer animal pathogens, a plant pest, plant biological agent, or other material listed below.

NOTE: an import permit may required for interstate transfer of a USDA regulated materials.

USDA/APHIS Guidelines on exempt materials are provided and may include materials such as proteins, enzymes, genetic materials can be found here.

Materials that do not require a USDA Import Permit

SPECIAL NOTE: However, to facilitate entry at the U.S. port, your exporter should provide a letter containing specific information (see Guidelines 1100-1122 below) about the material. This letter should be included with the shipping documents and be available for review by U.S, port officials at the port of arrival. (This means the document should NOT be placed inside the package--or port officials will not have access to it.)

1100 Human Pharmaceuticals and Human Vaccines Containing Animal Components

1101 Human and Non-Human Primate Material (excluding cell cultures)

1102 Feline and Canine Material

1103 Live Laboratory Mammals and Their Material (for research purposes)

1104 Amphibians, Fish, Reptiles, Shellfish and Aquatic Species(includes venom)

1105 Chemically Synthesized Materials

1110 Microbially Produced Materials

1114 Recombinant Microbes and Their Products

1116 Non-pathogenic Microorganisms

1120 Cell Cultures/Lines, Recombinant Cell Cultures/Lines, and Their Products (for in vitro use)

1121 Test Kits

1122 Animal Feeds, Feed Supplements, and Pre-Mixes

Contact Information:
USDA, APHIS, VS
National Center for Import and Export
4700 River Road, Unit 40
Riverdale, MD 20737
PH: (301) 734-3277
FAX: (301) 734-8226

FDA Import Permit

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.

View FDA Import Permit Program here.

U.S. Fish and Wildlife Permit

A permit may be required for transporting fish, wildlife, endangered species, or materials. http://international.fws.gov/permits/permits.html

View U.S. Fish and Wildlife Permit Program here.

Select Agents (Shipping/Transfer)

The transfer or shipment of Select Agents and Toxins is also regulated by the CDC and the USDA. Importation requires either a CDC/PHS Import Permit or an APHIS VS Permit, depending on the agent. Agents are categorized as either a CDC, USDA, or overlap (both agencies) agent and each agency’s rules apply. Intrastate transfer (e.g., VA to MD or any other state) requires a VA Permit for all USDA/APHIS regulated agents.

A list of agents and their respective agency can be found here.

Export License

Several Government Agencies restrict the export of certain research research activities involving technological, biological, chemical and military-related research (e.g., those with direct military applications or commercial or "dual use" application that may also have military application) when foreign nationals are involved in any segment of the research project. The regulations may require in such circumstances that the University apply for a license with the appropriate agency, or find and record an exception to the regulations. Licenses are not easily obtained and require careful preparation and an inordinate amount of lead-time. Penalties are severe for non-compliance, including monetary and criminal punishment.

The definition of an "export" is quite broad. In addition to the shipment or transmission of technology or software either out of the United States or to a foreign national within the United States, a "deemed export" is considered to be the verbal, written electronic, and/or visual disclosures of controlled scientific and/or technical information related to export controlled items to foreign nationals in the United States.

An Export License may be required from the Commerce Department’s Bureau of Industry and Security (BIS) Export Administration Regulations (EAR), the State Department’s International Traffic and Arms Regulations (ITAR) or the Treasury Department’s Office of Foreign Assets Control (OFAC) Regulations.

For more information on export of research materials, contact the Office of Sponsored Programs at email, website, or FAQ.

Export of Biological Materials

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, an EAR Export License may be required. Contact EHS Biosafety (982-4911) if you are planning on exporting infectious substances (Category A or B only). An EAR license may be required if:

  • An item on the EAR Commerce Control List (CCL), or information concerning a listed item, is to be exported; or
  • The information or equipment is subject to EAR but not on the CCL and:
    • the destination is a country with restricted entities on the EAR Entity List (currently, certain entities in China, India, Israel, Pakistan, or Russia);
    • the end user is on the Denied Persons or Specially Designated Nationals Lists;
    • the destination is an OFAC-embargoed country (currently Cuba, Iran, Liberia, Libya, North Korea, Burma (Myanmar), Sudan, Syria, or Zimbabwe, and under some circumstances, Iraq);5
    • the destination is another U.S.-embargoed country (i.e., Rwanda); or
    • the export will support a nuclear, missile, chemical or biological weapons program.

If the destination is an OFAC-embargoed country, an OFAC license also may be required.

Exemptions

Most research at the University of Virginia and other universities is exempt from EAR and ITAR under one of three key exclusions:

  1. the research involves "fundamental research" (so long as there are no restrictions on publication of the research or other restrictions on the dissemination of the information);
  2. the research involves information that is "publicly available" (EAR) or that is in the "public domain" (ITAR);4 or
  3. the research involves "educational information" (i.e., information released by instruction in catalog courses and associated teaching laboratories at academic institutions in the United States, other than for certain encrypted software).

More information on Export Controls can be found at:

Commerce Department – Bureau of Industry and Security (BIS EAR)

International Traffic and Arms Regulations (ITAR)

Office of Foreign Assests Control (OFAC)

Export FAQs

License requirements depend on:

  • What is being exported
  • Where the item is being exported to
  • Who the item is being exported to
  • How the item will be used
  • If an item is sent from the United States to a foreign destination or a foreign national (within the U.S. or any other location)

Examples:

  • Commodities - such as biological, chemical, and radioactive materials
  • Software and technology - such as blueprints
  • Electronic Components – such as circuit boards