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Shipping Biological Materials

The U.S. Department of Transportation (US DOT) and the International Air Transport Association (IATA) requires you be trained and certified before shipping biological and bio-hazardous materials. Even if someone else handles your shipment for you, you are responsible for packaging and labeling biological materials correctly, and providing the required documentation. Fines for non-compliance and potential legal action can occur if you are found to have willfully ignored hazardous materials shipping regulations.

Materials Regulated by DOT/IATA

The following materials are regulated by DOT/IATA and require special packaging, labeling, and documentation.

In addition, you must complete a Material Transfer Agreement (MTA) to ship materials off campus, and ensure any required permits to import, export, or transfer materials have been obtained.

Category A Infectious Substances

  • An infectious substance which is transported in a form that, when exposure to the material occurs, is capable of causing permanent disability, life-threatening or fatal disease in otherwise health humans or animals. 
  • A diagnostic specimen that is suspected of containing a Category A Infectious Substance.
  • A patient specimen that is suspected of containing a Category A Infectious Substance. 

Category A Substances 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 pseudomalli -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
  • Hantaviruses causing hantavirus pulmonary 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
  • Rickettsia prowazekii (cultures only)
  • Rickettsia rickettsii (cultures only)
  • Rift Valley fever virus
  • Russian spring-summer encephalitis virus (cultures only)
  • Sabia virus
  • Shigella dyseteriae type 1 (cultures only)
  • Tick-borne encephalitis virus (cultures only)
  • Variola virus
  • Venezuelan equine encephalitis virus
  • West Nile virus (cultures only)
  • Yellow fever virus (cultures only)

Category A Substances Affecting Animals 

  • African swine fever virus cultures
  • Avian paramyxovirus type 1—Velogenic Newcastle disease virus cultures
  • Classical swine fever virus cultures
  • Foot and mouth disease virus cultures
  • Lumpy skin disease virus cultures
  • Mycoplasma mycoides—Contagious bovine pleuropneumonia cultures
  • Peste des petits ruminants virus cultures
  • Rinderpest virus cultures
  • Sheep-pox virus cultures
  • Goatpox virus cultures
  • Swine vesicular disease virus cultures

Category B Infectious Substances

  • Category B infectious substances are those infectious substances which do not meet the criteria for inclusion in Category A. 
  • A diagnostic specimen that is suspected of containing Category B Infectious substances. 
  • A patient specimen that is suspected of containing Category B Infectious substances. 

Genetically Modified Organisms

  • Organisms and micro-organisms in which genetic material has been purposefully altered through genetic engineering in a way that does not occur naturally and which are capable of altering animals, plants, or microbiological substances in such a way which is not normally the result of natural replication or reproduction. 

Dry Ice 

  • The shipment of ANY biological materials on dry ice is regulated
  • It is illegal to ship regulated biological material without proper training due to the ever-changing regulations and heavy documentation that must accompany each shipment.  Training is also required when dry ice is used as refrigerant. 

Materials Not Regulated by DOT/IATA

The following are not regulated for shipping by IATA/DOT unless they are packaged with another material that is regulated (e.g. dry ice); however, you must still complete a Material Transfer Agreement (MTA) to ship materials off campus.

Materials Exempt from IATA/DOT Regulations

  1. Patient specimens with minimal likelihood that pathogens are present.
    • Patient specimens are defined as 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.
    • In determining whether a patient specimen has a minimal likelihood that pathogens are present, an element of professional judgment is required to determine if a substance is exempt. That judgment should be based on the known medical history, symptoms and individual circumstances of the source, human or animal, and endemic local conditions.
    • Examples of specimens that can be transported as patient specimens:
      • Blood or urine tests to monitor cholesterol levels, blood glucose levels, hormone levels, or prostate specific antigens.
      • Tests required to monitor organ function such as heart, liver or kidney function for humans or animals with non-infectious diseases, or therapeutic drug monitoring.
      • Tests conducted for insurance or employment purposes and are intended to determine the presence of drugs or alcohol
      • Pregnancy tests
      • Biopsies to detect cancer
      • Antibody detection
    • NOTE- Patient specimen packaging must be labeled either; "Exempt human specimens" of "Exempt animal specimens".
  2. Substances that do not contain infectious substances or substances which are unlikely to cause disease in humans and/or animals. 
  3. Substances in a form that any present pathogens have been neutralized or inactivated such that they no longer pose a health risk.
  4. Substances containing microorganisms, which are non-pathogenic to humans and/or animals.
  5. Dried blood spots collected by applying a drop of blood onto absorbent material, or fecal occult blood screening tests and blood or blood components, which have been collected for transfusion.
  6. Tissue or organs intended for transplantation.
  7. Environmental samples (including food, water, and soil samples), which are not considered to pose a significant risk of infection. 

Additional information

For assistance in shipping biological materials, please contact Dr. Abigail Fish at [email protected].  Training may be required and can be found online in EHS-Assistant. 

 

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