Biological Substance, Category B, Specimens: Brief overview of Packaging and shipment requirements

Packing and Transport of
BIOLOGICAL SUBSTANCE, CATEGORY B, SPECIMENS

Biological Substances, Category B, are defined as human or animal material, including excreta, secreta, blood and its components, tissue and tissue fluids, being transported for diagnostic or investigational purposes, but excluding live infected humans or animals.

A specimen which meets the definition of Biological Substance, Category B, (being transported for diagnostic or investigational purposes), but is known to originate from a human or animal patient with an infectious disease should still be transported as a Biological Substance, Category B, specimen.

USDOT and IATA Requirements for Shipping Specimens

When shipping specimens, it is essential that each specimen be packaged and shipped properly. Complying with the regulations set forth by the DOT and the International Air Transport Association (IATA) will control or eliminate many health and financial liabilities, both criminal and civil. Other shipping regulations (IATA, CFR 29, 42 and 49, ICAO, and USPS) may also apply, depending on the transport service used. It is the responsibility of the shipper to ensure that any changes and/or modifications of these rules and regulations are reviewed and implemented in a timely manner.

The following rules apply for all specimens:

• The primary receptacle must be leak-proof and not contain more than 500 mL or grams.
• There must be absorbent material placed between the primary receptacle and the secondary packaging sufficient to absorb the entire contents of all primary containers within the secondary package.
• The primary receptacle or the secondary packaging must be capable of withstanding, without leakage, an internal pressure differential of not less than 95 kPa.

Instructions for preparing Biological Substances, Category B specimens:

Instructions for shipping Biological Substance, Category B specimens:

• Clients who ship their own specimens must make sure the shipping container has the words “Biological Substances, Category B” and “UN3373” on both the box and the Air Waybill under “description.”
• Submission form(s) should be filled out completely, placed in a protective plastic bag or sleeve and enclosed between the secondary packaging and the outer packaging.
• To keep the samples close to refrigerated temperature, pack a generous amount of frozen gel packs around the specimens within shipping container.

All specimens must be bagged separately with the appropriate paperwork. The source (i.e., animal species) of the specimen is required.

References:
IATA Dangerous Goods Regulations 50th Edition, Effective 1 January - 31 December, 2009
Code of Federal Regulations, 49CFR Parts 100 to 185, revised as of October 1, 2007.

• Submission form
• Specimen Collection Guide for large animals
• K-State Rabies Laboratory address labels for diagnostic samples
• UN3373 labels for labeling of packages to be sent by overnight shippers