Shipping Biological Materials
Introduction
Packaging and shipping biological materials involve certain risks with numerous potential liabilities. The International Air Transport Association (IATA), Dangerous Goods Regulations (DGR), latest edition, is the worldwide gold standard for shipping. The IATA regulations apply to all air transport, both domestic and international. By following the IATA DGR, you ensure that your package will also meet U.S Department of Transportation (DOT) requirements for ground transport. All responsibility for packaging and shipment of these agents have been assigned to the shipper. These include classification of shipment, proper packaging of shipment, proper marking and labeling of package, and proper documentation of shipment.
Transport of biohazardous goods requires training and certification prior to shipping. Training is mandatory for shippers (the person sending out the package or signing the air bill) and handlers (the people who transport the package) and is based on these regulations. Non-conformance of these regulations can result in a fine to the department found lacking. Training for Shipping and Transport of Regulated Biological Materials is available online through CITI and must be taken every two years.
Note: Dry Ice is considered a Dangerous Good. Training and certification are required, and the package must be labeled and shipped accordingly!
Services available
UI Biosafety provides the following services:
- Shipping consultation and assistance with packaging
- Biological materials classification, labels, assessment, and regulatory interpretations
- Contact Biosafety Officer at least week ahead of shipping date for assistance in shipping package.
Classification of Shipment Type
A shipment of biological material will fall into one of the five following categories:
Unregulated biological materials are not subject to IATA or DOT infectious substance shipping regulations; however, these materials may require a permit for shipment abroad. Please check with UI Biosafety if you have any question as to whether your shipment is unregulated. Some examples of unregulated biological materials include:
- Substances which do not contain infectious agents, and which should not cause disease in humans or animals. These include non-infectious cells or tissue cultures; blood, plasma, or sera from humans or animals not suspected of having an infectious disease; DNA, RNA, or any other genetic elements that are not themselves infectious.
- Microorganisms that are not pathogenic to humans, animals, or plants.
- Substances that have been neutralized or inactivated such that they are no longer infectious.
- Environmental samples that are not known, or thought to be, infectious.
- A biological product such as an antibody or drug.
Infectious substance: According to DOT and IATA, a material known of reasonable expected to contain a pathogen. A pathogen is a microorganism (including bacteria, viruses, rickettsiae, parasites, fungi) or other agent such as a proteinaceous infectious particle (prion) that can cause disease in humans or animals. Infectious substances are assigned to two categories.
Category A Infectious Substances: Category A infectious substances are capable of causing disease in humans or animals. The proper shipping name for Category A Infectious Substances is Infectious Substance Affecting Humans (UN2814), or Infectious Substance Affecting Animals (UN2900). These substances are classified as DOT hazard class 6.2 (infectious). Contact the Biosafety Officer at least 3 weeks in advance if you will be shipping Category A Infectious Substances.
Examples of Category A infectious substances are:
UN2814, Infectious Substance Affecting Humans
- Bacillus anthracis (cultures only)
- Brucella abortus (cultures only)
- Brucella melitensis (cultures only)
- Brucella suis (cultures only)
- Burkholderia mallei – Pseudomonas mallei – Glanders (cultures only)
- Burkholderia pseudomallei – Pseudomonas pseudomallei (cultures only)
- Chlamydia psittaci – avian strains (cultures only)
- Clostridium botulinum (cultures only)
- Coccidioides immitis (cultures only)
- Coxiella burnetii (cultures only)
- Crimean-Congo hemorrhagic fever virus
- Dengue virus (cultures only)
- Eastern equine encephalitis virus (cultures only)
- Escherichia coli, verotoxigenic (cultures only)
- Ebola virus
- Flexal virus
- Francisella tularensis (cultures only)
- Guanarito virus
- Hantaan virus
- Hantavirus causing hemorrhagic fever with renal syndrome
- Hendra virus
- Hepatitis B virus (cultures only)
- Herpes B virus (cultures only)
- Human immunodeficiency virus (cultures only)
- Highly pathogenic avian influenza virus (cultures only)
- Japanese Encephalitis virus (cultures only)
- Junin virus
- Kyasanur Forest disease virus
- Lassa virus
- Machupo virus
- Marburg virus
- Monkeypox virus
- Mycobacterium tuberculosis (cultures only)
- Nipah virus
- Omsk hemorrhagic fever virus
- Poliovirus (cultures only)
- Rabies virus (cultures only)
- Rickettsia prowazekii (cultures only)
- Rickettsia rickettsii (cultures only)
- Rift Valley fever virus (cultures only)
- Russian spring-summer encephalitis virus (cultures only)
- Sabia virus
- Shigella dysenteriae type 1 (cultures only)
- Tick-borne encephalitis virus (cultures only)
- Variola virus
- Venezuelan equine encephalitis virus (cultures only)
- West Nile virus (cultures only)
- Yellow fever virus (cultures only)
- Yersinia pestis (cultures only)
UN2900 Infectious Substances Affecting Animals:
- African swine fever virus (cultures only)
- Avian paramyxovirus Type 1 – Velogenic Newcastle disease virus (cultures only)
- Classical swine fever virus (cultures only)
- Foot and mouth disease virus (cultures only)
- Goatpox virus (cultures only)
- Lumpy skin disease virus (cultures only)
- Mycoplasma mycoides – Contagious bovine pleuropneumonia (cultures only)
- Peste des petits ruminants virus (cultures only)
- Rinderpest virus (cultures only)
- Sheep-pox virus (cultures only)
- Swine vesicular disease virus (cultures only)
- Vesicular stomatitis virus (cultures only)
Infectious substance: According to DOT and IATA, a material known of reasonable expected to contain a pathogen. A pathogen is a microorganism (including bacteria, viruses, rickettsiae, parasites, fungi) or other agent such as a proteinaceous infectious particle (prion) that can cause disease in humans or animals. Infectious substances are assigned to two categories.
Category B Infectious Substances (UN 3373): An infectious substance that is not generally capable of causing permanent disability or life-threatening or fatal disease in otherwise healthy humans of animals when exposure occurs. Category B infectious substances are materials that are infectious, but do not meet the definition of Category A infectious substances. These include patient samples, tissue cultures, and cells that are presumed to contain, or have a reasonable probability of containing, a pathogenic organism (e.g., blood known to contain HIV). The proper shipping name for these substances is "Biological Substance, Category B (UN3373)".
If a specimen taken directly from a patient has a minimal likelihood of containing pathogens and medical history indicates no pre-existing pathogens (e.g., HIV, HBV). This determination is based on the known medical history, symptoms, and the individual circumstance of the source animal or human.
GMOs and GMMOs are organisms in which their genetic material has been altered through recombinant DNA techniques. If a GMO is non-infectious it is classified as a DOT class 9 (miscellaneous) hazard and is assigned to UN3245. If a GMO is potentially infectious, it must be assigned as a Category A infectious agent (UN2814 or UN2900), or Category B infectious agent (UN3373). If shipping outside the United States, contact UI Office of Research Administration (ORA) Export Controls for assistance in determining any specific export licensing requirements before proceeding.