Shipping and Transportation of Biologicals

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 HSC staff, faculty, and students, packing and shipping Class 6.1, 6.2 and 9 substances, are required to complete biannual training.
• 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
  • 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:
    1. The UN 3373 label with the Proper Shipping Name Biological Substances, Category B next to the diamond
    2. 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.
    3. Category B shipments DO NOT require an Infectious Substance label, Shipper’s Declaration for Dangerous Goods or emergency response information.
    4. For details on shipping Category B infectious substances, visit:  http://www.iata.org/NR/rdonlyres/9C7E382B-2536-47CE-84B4-9A883ECFA040/0/Guidance_Doc62DGR_50.pdf

References:

1. IATA Packing Instruction 650 – Biological Substances, Category B
2. DOT 49 CFR Parts 171-180
3. DOT Pipeline and Hazardous Materials Safety Administration: How to transport infectious substances
4. NIH: Biological Materials Shipping