○ Customs Officials require infectious shipments crossing international borders to have import and export permits
○ The sender must obtain export permits
○ The receiver (consignee) must obtain the required import permits
○ Export permits
■ The Department of Commerce requires that exporters of a wide variety of etiologic agents of human, plant, and animal diseases, including genetic material, and products
which might be used for culture of large amounts of agents, acquire an export license.
○ US permitting Agencies
■ Department of Health and Human Services (CDC)
● Etiologic Agent Import Permit Program
○ Importer is legally responsible for assuring that the foreign personnel package, label and ship the infectious materials according to Federal and international regulations.
○ The importer must send required labels and one or more copies of the permit to the shipper.
●
Select Agent Permit Program
○ Individuals wishing to import select agents must be registered with CDC's Select Agent Program
○ Permission must be granted by the program prior to the shipment.
■ US Department of Agriculture
● Genetically engineered organism, plants, pests, organisms, vectors, cell cultures and products, live animals
● Will issue importation permit via APHIS
● May require USDA inspection
● FDA Import Permits
○ All food (except most meat and poultry),
drugs, biologics, cosmetics, and medical devices require a permit or registration before importation into the U.S.
■ US Department of Commerce
● Bureau of Industry and Security
○ Regulates the exportation of etiologic agents and technology
○ Export license for shipping certain technologies to restricted countries
○ Commerce Control List
■ US Department of the Interior
● Fish and Wildlife Service and National Marine Fisheries Service
○ Fish and Wildlife Service permits
are required for marine mammals, certain fish, and certain live animals, including bats.
○ Importation of certain plants, birds, and animals for scientific and other purposes
● CITES: Convention on INternational Trade in Endangered Species of Wild Fauna and FLora
○ Most countries have import regulations requiring import permits for
■ most non-domesticated animals (usually not including rodents)
■ Animal parts
■ Animal products
○ Each country administers CITES agreement
differently
■ USE→ DOI
Home ▸ Laboratory Safety ▸ Biological Safety ▸ IATA/DOT: Requirements For Shipping Biological Materials
International Air Transport Association/ US Department of Transportation
IATA Packing and Shipping Requirements of Class 6.1 Toxins, 6.2 Biological Substances and Class 9 Miscellaneous (Dry Ice Shipments)
Biological specimen shipments and shipments over dry ice are regulated and as such have specific packaging requirements that meet the requirements of the Department of Transportation (DOT) (domestic shipments in the United States), Transportation of Hazardous Materials Regulations (HMR), and International Air Transport Association (IATA) (international air shipments worldwide) and Dangerous Goods Regulations (DGR).
General Requirements
- All GU staff, faculty, and students, packing and shipping Class 6.1, 6.2 and 9 substances, are required to complete biannual training. Training is offered as a courtesy by EH&S and conducted as necessary. Visit the training page to request access to the IATA/DOT training via Canvas.
- The International Air Transport Association (IATA) Dangerous Goods Regulations (DGR) classifies Class 6.2 infectious substances into two categories, Biological substance, Category A and Biological substances, Category B:
- Biological Substance, Category A: an infectious substance which in a form that, when exposure to it occurs, is capable of causing permanent disability, life-threatening or fatal disease in otherwise healthy humans or animals. The proper shipping names for these substances are: UN2814 (infectious substances, affecting humans) and UN2900 (infectious substances, affecting animals)
- Biological Substance, Category B: An infectious substance which does not meet the criteria for inclusion in Category A. Infectious substances in category B must be assigned to UN 3373.
- DOT Hazardous Materials Division 6.2 materials can include:
- Biological products
- Cultures and stocks
- Diagnostic specimens
- Regulated medical waste
- Sharps
- Toxin
- Used health care product
- DOT Hazardous Materials Division 6.2 materials can include:
- Note: Environmental samples (including food and water samples) which are not considered to pose a significant risk of infection are generally not subject to the IATA or USDOT shipping requirements and are considered “EXEMPT”.
- Packing materials must be of good quality and strong enough to withstand leakage, shocks, pressure changes, humidity, vibration, and manual or mechanical handling. More specifically, the contents should not leak to the outside of the shipping container even if there should be leakage of the primary receptacle during transit. The packaging should be resilient enough to withstand rough handling, passage through sorters, conveyors and other similar equipment.
- All Category B infectious substances require three components
(“triple packaging”) for shipment:
- Leak-proof Primary Receptacles
- Leak-proof Secondary Packaging
- Outer Packaging
- The minimum required outer container markings and labels include:
- The UN 3373 label with the Proper Shipping Name Biological Substances, Category B next to the diamond
- The outer container must also have the name, address and telephone number of the shipper, as well as the name, address and telephone number of the receiver/consignee.
- Category B shipments DO NOT require an Infectious Substance label, Shipper’s Declaration for Dangerous Goods or emergency response information.
- For details on shipping Category B infectious substances, visit: //www.iata.org/NR/rdonlyres/9C7E382B-2536-47CE-84B4-9A883ECFA040/0/Guidance_Doc62DGR_50.pdf
References:
- IATA Packing Instruction 650 – Biological Substances, Category B
- DOT 49 CFR Parts 171-180
- DOT Pipeline and Hazardous Materials Safety Administration: How to transport infectious substances