SHIPMENT OF BIOLOGICAL MATERIALS

  1. Table 1: Category A Infectious Substances
  2. Table 2: Shipping Summary Table
  3. Packing Instruction 602
  4. Packing Instruction 650
  5. Packing Instruction 904
  6. Packing Instruction 913
  7. Exempt Packing Instructions

The Department of Transportation (DOT), the United States Postal Service (USPS), the Centers for Disease Control (CDC), and the International Air Transport Association (IATA) all have requirements for shipping hazardous materials (Dangerous Goods). Biological materials and infectious substances are one of several types of dangerous goods that may be offered for shipment. All hazardous materials are required to be classified, packaged, labeled and documented properly prior to shipment.

Therefore, all USciences personnel who need to ship biological materials, hazardous materials, or materials on dry ice must contact the Department of Environmental Health and Radiation Safety (EHRS) to help package and prepare the paperwork. Anyone wishing to ship materials on their own or who is shipping frequently (i.e., once a month or more) must first receive the required training and certification.

DEFINITIONS

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

Infectious substances are assigned to UN classes based on the following definitions:

Biological Products including an experimental or investigational product are those products derived from living organisms and manufactured for use in the prevention, diagnosis, treatment or cure of diseases in humans or animals and are certified by the USDA, FDA, or other national authority. They include, but are not limited to, finished or unfinished products such as vaccines, diagnostic products, therapeutic serums, toxins and antitoxins.

Biological products that 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, are not subject to shipping regulations. [Follow the Exempt Packing Instructions]

Genetically Modified Microorganisms and Organisms are organisms or microorganisms which have been purposely altered through genetic engineering in a way that does not occur naturally. Pathogenic GMOs must be classified as either Category A (Packing Instruction 602) or Category B (Packing Instruction 650) infectious substances and shipped accordingly.

Non-pathogenic GMOs that are capable of altering animals, plants, or microbiological substances in a way which is not normally the result of natural reproduction are considered Class 9 Miscellaneous Dangerous Goods and assigned to UN3245. They have the proper shipping names, "genetically modified organisms" or "genetically modified microorganisms". [Follow Packing Instruction 913]

Patient Specimens are those 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 purposes such as research, diagnosis, investigational activities, disease treatment and prevention.

If there is more than a "minimal likelihood" that a patient specimen contains pathogens, it must be shipped as a Category A infectious substance (UN2814 or UN2900), or a Category B infectious substance (UN3373).

Patient specimens unlikely to contain pathogens must be prepared for shipment by following the exempt packing instructions. [Follow the Exempt Packing Instructions]

Cultures are the result of a process by which pathogens are intentionally propagated. This definition does not include patient specimens as defined above. Cultures of infectious substances will either be Category A or Category B.

Dry Ice is a Class 9 Dangerous Good. Packages containing dry ice must be labeled with the proper shipping name, "Dry Ice" or "Carbon dioxide, solid" and is assigned UN1845. A Shipper's Declaration Form is only required when the dry ice is used as a refrigerant for dangerous goods that require a Shippers Declaration. [Follow Packing Instruction 904] Special packaging and arrangements must be made with the carrier for packages containing liquid nitrogen.

Dry Ice must be packaged to permit the release of carbon dioxide gas and to prevent a build-up of pressure that could rupture the packaging.

Information on shipping radioactive materials.


University of the Sciences in Philadelphia • 600 South Forty-third Street • Philadelphia, PA 19104-4495 • phone: 215-596-8800 • email: safety@usp.edu