Changes in US Department of Transportation (DOT) Shipping Regulations for clinical specimens effective Oct.1, 2006* *Previous labeling allowed until January 1, 2007. Images from: http://hazmat.dot.gov/training/Transporting_Infectious_Substances_Safely.pdf Background
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*Previous labeling allowed until January 1, 2007.
An infectious substance is regulated as a hazardous material under the U.S. Department of Transportation (DOT)’s Hazardous Materials Regulations (HMR; 49CFR Parts 1717-180). The HMR apply to any material DOT determines is capable of posing an unreasonable risk to health, safety, and property when transported in commerce. An infectious substance must conform to all applicable HMR requirements when offered for transportation by air, highway, rail, or water.
The HMR classifies hazardous materials. Division 6.2 (infectious substance) is for materials known or reasonably 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.
Now --DOT requirements are harmonized with the United Nations Recommendations.
A two-tiered classification
system has been
set up for infectious
A and B.
Infectious substances, affecting humans UN2814
Infectious substances, affecting animals UN2900
Biological Substances, Category B UN23373
An infectious substance containing a pathogen that is
Intentionally propagated. Culture does not include a
Human or animal patient specimen as defined below:
Human or animal materials collected directly from humans or animals and transported for research, diagnosis, investigational activities, or disease treatment or prevention. Patient specimen includes excreta, secreta, blood and its components, tissue and tissue swabs, body parts, and specimens in Transport Media (e.g. transwabs, culture media, and blood culture bottles.)
Definitions from § 171.134
Bacillus anthracis (cultures only)
Crimean-congo hemorrhagic fever
Highly pathogenic avian influenza virus (cultures only)
An infectious substance not in a form generally capable
of causing permanent disability or life-threatening or fatal disease in otherwise healthy humans or animals when exposure to it occurs.
This includes Category B infectious substances transported for diagnostic or investigational purposes.
Proper shipping name and identification number:
Biological substance, Category B UN3373
Classification Scenarios- Category A List?
Example 1: Blood sample taken from a patient known or suspected to have Hepatitis C and HIV.
Proper shipping classification:
Biological Substance, Category B, UN3373
Example 2: Blood sample from a patient known or suspected to have Ebola.
Proper shipping classification:
Infectious substance, Affecting Humans. UN2814
The regulation still states:
§173.199For liquid shipments by aircraft, the primary receptacle or the secondary packaging must be capable of withstanding without leakage an internal pressure producing a pressure differential of not less than 95 kPa
1) Use packaging certified for air transport.
2) If you prepare shipments using recycled materials, the primary containers must meet this requirement. [Vacutainers and Corning cryovials do; obtain documentation on other containers shipped].
*For category B, this does not have to be a 24-hour number. However, it should be a phone which is answered during normal business hours.
Biological substances, Category B
Example below from www.casingcorp.com/un3373_labels.htm.
Example:catalog number 22-130-067, from www.fishersci.com
Then “diagnostic specimen’ or “clinical specimen” must be replaced with
“Biological Substance, Category B”
You may start using the new label now.