Shipping Infectious Substances
Infectious Substances are those substances containing viable microorganisms or their toxins, which are known or suspected to cause disease in humans (see 42 CFR 72 for definition). These are also known as etiologic agents.
Packaging and transport of clinical samples, biological substances and infectious specimens must comply with applicable Department of Transportation Code of Federal Regulations (CFR) 49, Department of Labor CFR 29, Postal Services CFR 39, Department of Health and Human Services CFR 42 and the International Air Transport Association (IATA).
Note this important rule from the U.S. Department of Transportation: No person may knowingly transport or cause to be transported in interstate traffic, directly or indirectly any material, including but not limited to, diagnostic specimens and biological products which such person reasonably believes may contain any etiologic agent unless such material is packaged to withstand leakage of contents, shocks, pressure changes, and other conditions incident to ordinary handling in transportation.
Universal Precautions are to be applied to all specimens in accordance with Oregon Occupational Safety & Health Codes Subdivision I and Z: Personal Protective Equipment (29 CFR 1910.132 – 1910.140), Bloodborne Pathogens (29 CFR 1910.1030).
Category A Description
Category A substances are infectious substances in a form capable of causing permanent disability or life-threatening or fatal disease in otherwise healthy humans or animals when exposure to them occurs. Classification must be based on the known medical history or symptoms of the source patient or animal, endemic local conditions, or professional judgment concerning the individual circumstances
of the source human or animal.
Examples of Category A
Cultures only, suspected or known to contain:
- Escherichia coli, vertoxigenic (an E. coli 0157:H7 isolate on an agar slant)
- Coccidioides immitis (an isolate on an agar slant)
- Mycobacterium tuberculosis (an isolate on an agar slant); Rabies virus (cultures only)
For a more complete description, read the Office of Materials Safety’s online brochure Transporting Infectious Substances Safely at www.phmsa.dot.gov
Examples of Category B
- Blood or plasma for Hepatitis C Virus RNA Qualitative testing
- Salmonella species. (could be an isolate on an agar slant or a patient sample from a known outbreak)
- Sputum specimens (to “rule out tuberculosis”)
Specimens that do not contain an infectious substance or that are unlikely to cause disease in humans or animals are not subject to the DOT rules for infectious materials. Examples include non-infectious blood or plasma from individuals not suspected of having an infectious disease or other infectious genetic elements.
Sections of U.S. Department of Transportation
49 CFR Parts 171 through 179 govern the transport of these materials on the ground, and other routes along with IATA regulations for air transportation.
Additional rules apply to Select Agents. Select Agents are microorganisms (virus, bacterium, fungus or rickettsia) or toxins listed in Appendix A to CFR 72 that may cause, among other issues, serious harm to the public.
For more information see Center for Disease Rules for select agents
- 42 CFR 71.54, Etiologic Agents, Hosts and Vectors
- 42 CFR 72.6, Interstate Shipment of Select Agents with additional requirements facilities
Shipping Infectious Substances/Etiologic Agents Via a Commercial Carrier
Clients who ship directly to PeaceHealth Laboratories via commercial carrier must make an assessment of the materials being offered and fill out required documentation. A freight forwarder may assist with document preparation. Note that containers must be labeled properly or the carrier may refuse to pick up the package. The primary specimen container and all shipping material must be appropriate for the conditions of transportation, including temperature and air pressure changes.
Follow U.S. Department of Transportation 49 CFR Parts 171 through 179. If specimens are mailed, follow U.S. Postal Service: 39 CFR Part 111 and Domestic Mail Manual (DMM) CO23 Hazardous Materials. IATA packing instruction #602 applies to infectious substances/etiological substances being transported by air. Carriers will not accept or ship improperly packaged or labeled materials.