The Hazardous Material Regulations (HMR) of the PHMSA/USDOT regulate the transportation in commerce of an Infectious Substance (Hazard Class 6, Division 6.2). The description of Division 6.2 at 49 CFR 173.134 includes a definition of both Regulated Medical Waste and Sharps, and an exception from full regulation under the HMR for Regulated Medical Waste if shipped as required. The purpose of this article is to explain the requirements to comply with the exception for transportation of a Regulated Medical Waste.
Before I can explain the RMW exception I must describe an Infectious Substance. Its full definition, summarized below, is at 49 CFR 173.134(a)(1):
Division 6.2 (infectious substance) means a material 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.
A Division 6.2 Infectious Substance must be assigned to one of four HazMat Identification Numbers:
- UN 2814 Infectious substances, affecting humans
- UN 2900 Infectious substances, affecting animals only
- UN 3373 Biological substance, Category B
- UN 3291 Regulated medical waste, n.o.s. or Clinical waste, unspecified, n.o.s. or (BIO) Medical waste, n.o.s. or Biomedical waste, n.o.s., or Medical Waste n.o.s.
Interestingly, a search of the Hazardous Materials Table @ 49 CFR 172.101 reveals Hazard Division 6.2 is found only in association with the above four shipping descriptions.
In addition, a Division 6.2 Infectious Substance must be assigned to one of two categories defined @ 49 CFR 173.134(a)(1):
- 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. A Category A infectious substance must be assigned the identification number UN 2814 or UN 2900, as appropriate.
- 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. A Category B infectious substance must be described with the proper shipping name of “Biological substance, Category B” and assigned to identification number UN 3373. However, this does not include a Regulated Medical Waste or Clinical Waste or (Bio) Medical Waste, which must be assigned the HazMat Identification Number of UN 3291.
A Regulated Medical Waste or Clinical Waste or (Bio) Medical Waste is defined at §173.134(a)(5):
Regulated medical waste or clinical waste or (bio) medical waste means a waste or reusable material derived from the medical treatment of an animal or human, which includes diagnosis and immunization, or from biomedical research, which includes the production and testing of biological products. Regulated medical waste or clinical waste or (bio) medical waste containing a Category A infectious substance must be classed as an infectious substance, and assigned to UN 2814 or UN 2900, as appropriate.
So, a Regulated Medical Waste or Clinical Waste or (Bio) Medical Waste must be classified as follows:
- If a Category A: UN 2814 or UN 2900, as appropriate.
- If a Category B: UN 3291.
- It cannot be classified as a UN 3373.
§173.134(a) goes on to list and define the following additional Division 6.2 Infectious Substances:
- Biological product
- Patient specimen
- Sharps. Defined at §173.134(a)(6):
Sharps means any object contaminated with a pathogen or that may become contaminated with a pathogen through handling or during transportation and also capable of cutting or penetrating skin or a packaging material. Sharps includes needles, syringes, scalpels, broken glass, culture slides, culture dishes, broken capillary tubes, broken rigid plastic, and exposed ends of dental wire.
- Toxin, and
- Used health care product
§173.134(b) lists and explains materials specifically excluded from inclusion as a Division 6.2 Infectious Substance.
This means that Regulated Medical Waste or Clinical Waste or (Bio) Medical Waste and sharps are hazardous materials (HazMat) subject to the HMR when offered for transportation in commerce. However, §173.134(c) includes an exception for Regulated Medical Waste (RMW) if transported by a private or contract carrier.
First of all, note that while its definition at §173.134(a)(5) refers to it as Regulated Medical Waste or Clinical Waste or (Bio) Medical Waste, here it is referred to only as Regulated Medical Waste. Also, though defined separately at §173.134(a)(6), sharps are included in the language of this exception. The reason for these seeming inconsistencies is found in the intent of the exception which is to include any material that may meet the definition of a Category B Regulated Medical Waste (RMW) within this exception.
Per §173.134(c)(1), a RMW is excepted from both HazMat Labels and specification packaging.
- The INFECTIOUS SUBSTANCE HazMat label is not required if the outer packaging is marked with a BIOHAZARD label per OSHA regulations (29 CFR 1910.1030).
- Specification packaging per 49 CFR 173.197 is not required if:
- Packaged in a rigid non-bulk packaging, and
- Packaging conforms to the general packaging requirements of §173.24 & §173.24a, and OSHA regulations of 29 CFR 1910.1030, and
- The material does not include a waste concentrated stock culture of an infectious substance.
- In addition to the above, sharps containers must be securely closed to prevent leaks or punctures.
§173.134(c)(2) expands the definition of RMW to include materials that may not even be subject to the HMR (“documents” & “equipment”, see below) to be transported as RMW if the following is true:
- The packaging requirements of §173.134(c)(1)(ii) are met, and
- The vehicle is used exclusively to transport RMW. Though not defined, as used in the HMR, used exclusively means the vehicle is used for the transportation of a single commodity or class of commodities (PHMSA Interpretation 07-0057).
Those materials that may be shipped as a RMW under these conditions are:
- Waste stock or culture of a Category B infectious substance;
- Plant and animal waste regulated by the Animal and Plant Health Inspection Service (APHIS);
- Waste pharmaceutical materials;
- Laboratory and recyclable wastes;
- Infectious substances that have been treated to eliminate or neutralize pathogens;
- Forensic materials being transported for final destination;
- Rejected or recalled health care products;
- Documents intended for destruction in accordance with HIPAA requirements;
- Medical or clinical equipment and laboratory products provided they are properly packaged and secured against exposure or contamination; or
- Sharps if packaged as specified at §173.134(c)(2)(x)
The intent of §173.134(c)(2) is to prevent the inadvertent contamination of materials and products with RMW while allowing for their transportation within the same vehicle (PHMSA Interpretation 06-0277).
For more information, refer to the PHMSA guidance document: Transporting Infectious Substances Safely. It includes classification scenarios and lists of pathogens that may be Category A infectious substances.
A Division 6.2 Infectious Substance, including a Regulated Medical Waste, is a hazardous material (HazMat) subject to regulation under the HMR. This means that employees involved in its transportation (including loading, unloading, or handling and preparing or reviewing shipping papers) are HazMat Employees who require triennial training per 49 CFR 172, Subpart H. Please contact me with any questions you may have about Division 6.2, Regulated Medical Waste, or the transportation of hazardous materials.