This guideline has been prepared as an additional resource to assist in the classification of biological material for shipment. This guideline does not replace the requirement to complete the online training course,Shipping Infectious Substances with or without Dry Ice and is meant as a supplement to the course. The Biosafety Office at EHS has received several questions regarding how to classify commonly used research material and we have included these biologicals in the list below.
Category A Infectious Substances
Category A substances are infectious substances which are transported in a form that, when exposure to them occurs, is capable of causing permanent disability, life-threatening or fatal disease in otherwise healthy humans or animals. These shipments must follow Packing Instructions 620.
Infectious substances that would be shipped in this category include*:
- Bacillus anthracis (cultures only)
- Infectious substance 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 haemorrhagic 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
- Mpox virus (cultures only)
- Mycobacterium tuberculosis (cultures only)
- Nipah virus
- Omsk haemorrhagic 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
- SARS-Coronavirus (cultures only)
- SARS-Coronavirus 2 (cultures only)
- 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)
- 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)
Human blood may also fall into Category A; this classification requires professional judgment and is based on a patient’s known medical history, symptoms, individual circumstances of the source and endemic local conditions. For example, blood that has been drawn from a severely ill patient whose travel history and/or potential exposures place him/her at risk of infection with viruses such as Ebola, Lassa, Rift Valley Fever, etc., would need to be shipped as a Category A substance.
*This list is not all inclusive and is subject to change.
Biological Substances Category B
Category B substances are infectious substances which do not meet the criteria for inclusion in Category A. These shipments must follow Packing Instructions 650.
Examples of biological material that would be shipped in this category include:
- Adenovirus (replication competent).
- E. coli: Non K-12 derivatives that require biosafety level 2 containment.
- Recombinant viral vectors (replication defective); including AAV, Adenovirus, FIV, HIV.
- Human blood may also fall into Category B; again, this classification requires professional judgment and is based on a patient’s known medical history, symptoms, individual circumstances of the source and endemic local conditions. For example, if the blood has been drawn from a HepB/HIV-positive patient this blood would be classified as Category B (only CULTURES of HepB/HIV are Category A).
Exempt Shipments
Exempt human/animal specimens are specimens in which it is NOT LIKELY that a pathogen is present. Professional judgment must be used; if you suspect the specimen may contain an infectious substance, it must be shipped accordingly. These shipments should be packaged using a triple packaging system and marked as “exempt human specimen” or “exempt animal specimen.”
Exempt patient specimens include:
- Biopsies.
- Dried blood spots.
- Fecal occult blood screening test.
- Specimens (blood, urine, tissue) being sent for antibody detection, organ function or therapeutic drug monitoring, pregnancy, drug, insurance, or employment test purposes, etc.
- Tissues for transplant.
- Human blood may be exempt from shipping regulations. For example, blood taken from healthy patients that is not suspected to contain an infectious pathogen can be shipped as an exempt human specimen. Blood being shipped for tissue typing or transfusion, glucose, cholesterol, and hormone level testing, etc., would fall into this category.
Biological material that is not considered infectious can also be shipped as exempt.
This material includes:
- K-12 derived E. coli.
- Mammalian cell lines which have not been infected/transduced by a viral vector.
- Neutralized or inactivated pathogenic organism (formaldehyde/glutaraldehyde fixation or treatment with a disinfectant such as bleach).
- Non-infectious and non-toxic, pure DNA, RNA, or proteins (e.g., plasmids, primers, antibodies).