Hazmat in Healthcare: Division 6.2 and Medical Waste
Posted on 7/15/2014 by Ross Kellogg
Hazardous materials shippers have many responsibilities under US DOT regulations. The first and arguably most important step of the hazmat shipping process is classifying the material.
If this first step is done incorrectly, the packaging selected for the shipment may not be compatible or strong enough; the marks, labels, and shipping papers will be inaccurate; etc. In the event of an incident in transit, emergency responders will not have the information required to make the best judgment about how to react and respond. The classification requirement is found at 49 CFR 173.22.
With many materials, classification is a relatively simple process. Some hazmat, though, can be rather complicated to classify and may even require special expertise in a specific related field. One example of this is the classification of Division 6.2 infectious substances.
What Is a DOT “Infectious Substance”?
The US DOT defines an infectious substance as “a material known or reasonably expected to contain a pathogen.” [49 CFR 173.134] Pathogen is further defined as a microorganism (e.g., bacteria, viruses, parasites, fungi) or other agent, such as an infectious particle, that can cause disease in humans or animals. Examples are the Ebola virus and hoof-and-mouth disease and the cultures taken from them. Not all these pathogens are regulated the same way, if at all, and Division 6.2 is further divided into two categories:
Category A: An infectious substance in a form capable of causing permanent disability or life-threatening or fatal disease in otherwise healthy humans or animals when exposure to it occurs.
Category B: An infectious substance that is 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.
An exposure occurs when an infectious substance is released outside of its protective packaging, resulting in physical contact with humans or animals.
Exceptions to the Division 6.2 Shipping Rules
As with many hazmat shipping regulations, there are a number of exceptions that apply to specific materials. Here is a brief list:
A material that does not contain an infectious substance or that is unlikely to cause disease in humans or animals
A material containing micro-organisms that are non-pathogenic to humans or animals
Blood, blood plasma, and blood components for blood transfusion or of blood products and sent for testing, if believed not to contain a Category A or Category B infectious substance
Certain laundry and medical equipment and used healthcare products
Agricultural products and food as defined in the Federal Food, Drug, and Cosmetics Act
Having a medical background certainly could be helpful to make the distinction between a Category A and Category B substance. Following are some general guidelines and examples.
Category A vs. Category B Infectious Substances
A Category A infectious substance that is potentially fatal must be assigned to identification number UN 2814 or UN 2900, as appropriate. Assignment to UN 2814 or UN 2900 must be based on the known medical history, symptoms, or professional judgment concerning the source. UN 2814 is assigned to materials that can affect humans and UN 2900 to those that only affect animals. A blood sample from a patient know to have the Ebola virus, for example, would be assigned UN 2814, while one containing hoof-and-mouth disease would be UN 2900.
A Category B infectious substance must be described as “Biological substance, Category B” and assigned identification number UN 3373. This does not include regulated medical waste, which must be assigned identification number UN 3291. An example of a Category B substance is a tissue sample containing Hepatitis B.
Shipping Regulated Medical Waste
The rules for shipping regulated medical waste, UN 3291, differ from the infectious substance regulations. Sometimes known as clinical waste or (bio) medical waste, regulated medical waste is a waste or reusable material derived from the medical treatment of an animal or human or from biomedical research.
When packaged to the specific standards at 49 CFR 173.134(c)(2), some Category B infectious substances meet the definition of regulated medical waste. For example, Category B waste cultures transported as regulated medical waste conforming to certain packaging and transportation requirements can get relief from the majority of the regulations. Medical waste containing a Category A infectious substance, however, must be classed as an infectious substance and assigned to UN 2814 or UN 2900, as appropriate.
While medical-related hazmat makes up only a small portion of US hazmat shipments each year, the dangers posed by these materials are very real. By ensuring their materials are classified and named correctly, hazmat employees in the healthcare industry can be confident their shipments are safe in transit and that emergency response personnel have the best information possible to respond in the case of an emergency.
49 CFR Shipper Training for Medical Hazmat and Waste
For hazmat shippers in the medical industry, Lion offers online training for both Shipping Infectious Substances (and Dry Ice) and Shipping Regulated Medical Waste. Learn the US DOT regulations for classifying, naming, packaging, marking, labeling, loading, unloading, and documenting these hazmat shipments. The US DOT requires training for all hazmat employees once every three years, and fines for hazmat shipping mistakes are now as high as $75,000 per day, per violation.