Biological Materials Shipping

Shipping Regulated Biological Materials (DOT and IATA regulations)

1. Infectious substances

An infectious substance is defined as a substance which is known or reasonably expected to contain pathogens; pathogens are defined as microorganisms and other agents such as prions, which can cause disease in humans or animals.

Infectious substances are divided into two categories:

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 healthy humans or animals. Click for indicative examples of category A infectious substances.
  • 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 B infectious substances:

  • Category B infectious substances are those infectious substances which do not meet the criteria for inclusion in Category A
  • Patient specimens suspected of containing a Category B Infectious Substance.

2. Genetically Modified Organisms/ Microorganisms

Genetically modified organisms and micro-organisms (organisms and micro-organisms in which genetic material has been purposely altered through genetic engineering in a way that does not occur naturally) which are capable of altering animals, plants or microbiological substances in a way which is not normally the result of natural reproduction.

3. Dry Ice

The shipment of ANY biological materials on dry ice is regulated

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

Register for the Biological Substance Shipping learning track in Ability LMS and complete training every two years.

 

Before your biological materials can be packaged and shipped the following items must be completed:

  • A Material Transfer Agreement (MTA) must be filled out for materials that are being shipped off campus.
  • Ensure that any necessary permits have been obtained. The CDC, USDA and other regulatory agencies require permits for shipping certain etiological agents and other biological materials.

Please note that these paperwork requirements can take several weeks to complete, therefore you should prepare well in advance for them.

Non-regulated Biological Material Shipping

Non-regulated unless they are packaged with another material that is regulated (e.g., dry ice):

Note: You must still have a Material Transfer Agreement in place to send these materials off campus.

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

Patient specimen package must be labeled either: "Exempt human specimens" or "Exempt animal specimens."

2. Substances that do not contain infectious substances or substances which are unlikely to cause disease in humans 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 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 the purposes of transfusion

6. Tissues or organs intended for transplantation

7. Environmental samples (including food and water samples), which are not considered to pose a significant risk of infection

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