The Pipeline and Hazardous Materials Safety Administration within the U.S. Department of Transportation (USDOT/PHMSA) creates and enforces the Hazardous Materials Regulations (HMR) for the transportation of hazardous materials (HazMat) within the U.S. One type of HazMat regulated by USDOT/PHMSA are substances that may cause sickness or death to humans or animals: Division 6.2 Infectious Substances.
The purpose of this article is to describe USDOT/PHMSA’s classification of a Division 6.2 Infectious Substance and the hazard communication: package labels, marks, and placards required for its transportation.
Classification:
At 49 CFR 173.134 the PHMSA/USDOT defines an Infectious Substances as a Hazard Division 6.2 hazardous material when offered for transportation. A succinct summation of §173.134 includes the following:
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.
So, an infectious substance is a material that can cause – or has a very real potential to cause – disease to humans or animals.
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An Infectious Substance must belong to either Category A or Category B.
And…
There are only four shipping names listed in the Hazardous Materials Table identified with Hazard Division 6.2, they are:
- UN2814 Infectious substances, affecting humans
- UN2900 Infectious substances, affecting animals only
- UN3373 Biological substance, Category B
- UN3291 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.
The Identification and Transportation of a Regulated Medical Waste
Packaging:
Since it is critical to complying with these regulations, we must first identify the type of packaging to be used; bulk or non-bulk. Here the HMR take some of the decision out of our hands; how? Column 8B & 8C of the Hazardous Material Table; whose function it is to indicate the authorized packaging for a hazardous material as described in §173. In the case of the following Infectious Substances, there is no option for a bulk packaging (i.e., “None” appears in column 8C, whereas a reference to a section of §173 appears in column 8B). In other words, the following hazardous materials may only be transported in a non-bulk packaging since it is the only option offered in column 8 of the Hazardous Materials Table:
- UN2814 Infectious substances, affecting humans
- UN2900 Infectious substances, affecting animals only
- UN3373 Biological substance, Category B
That leaves us with UN3291 as the only Division 6.2 Infectious Substance that has the option to be shipped in a bulk packaging or a non-bulk packaging. With these very important limitations in mind, let’s proceed to determine what – if any – hazard communication is required on the Division 6.2 Infectious Substance packaging.
HazMat Labels:
The identification of the applicable HazMat Label for a non-bulk packaging of a hazardous material is found in column 6 of the Hazardous Materials Table. There we find, no surprise, that non-bulk packagings of the following must display the Infectious Substance HazMat Label as identified in §172.432:
- UN2814 Infectious substances, affecting humans
- UN2900 Infectious substances, affecting animals only
- UN3291 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.
As there is no HazMat Label code identified in column 6 of the Hazardous Materials Table for its entry, a HazMat Label is not required for UN3373 Biological substance, Category B.
Regarding the HazMat Label for UN3291, an exception exists at §173.134(c)(1)(i) that provides an option to use the OSHA-compliant BioHazard Label pursuant to 29 CFR 1910.1030(g) instead of the Infectious Substance HazMat Label.
Q: Does the exception at §173.134(c)(1)(i) apply to a bulk packaging of a Regulated Medical Waste as well?
A: No it does not, for two reasons. First of all, a bulk packaging is not required to display HazMat Labels. And secondly, §172.323 indicates specific marking requirement for a bulk packaging of Regulated Medical Waste.
Note that the ETIOLOGIC AGENT label specified in regulations of the Department of Health and Human Services at 42 CFR 72.3 may also be required to be displayed on packages of infectious substances.
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Package Marks:
49 CFR 172.323: a bulk packaging of UN3291 – and UN3291 only – must be marked with a BIOHAZARD marking conforming to 29 CFR 1910.1030(g)(1)(i). The display of this marking depends upon the volume of the bulk packaging:
- If the bulk packaging has a capacity of less than 3,785 L (1,000 gallons), then the BIOHAZARD mark must be displayed on two opposing sides or two ends – not the bottom.
- If the bulk packaging has a capacity of 3,785 L (1,000 gallons) or more, then the BIOHAZARD mark must be displayed on each end and each side.
Specifications for the BIOHAZARD package mark on a bulk packaging of Regulated Medical Waste:
OSHA BioHazard Symbol
- It must measure at least 152.4 mm (6 inches) on each side.
- It must be visible from the direction it faces.
- The background color must be orange and the symbol and letters must be black.
- It must be displayed on a background of contrasting color.
- It may be displayed on a plain white square-on-point configuration having the same outside dimensions as a placard.
Note that the ETIOLOGIC AGENT label specified in regulations of the Department of Health and Human Services at 42 CFR 72.3 may also be required to be displayed on packages of infectious substances.
Q: Are placards required on a bulk packaging of an Infectious Substance?
A: No. Pursuant to 49 CFR 172.500(b)(1) there is no placard for a Division 6.2 Infectious Substance.
We’re not done with package marks or with §172.323. However, the remaining requirements will be dealt with in the section regarding placards.
Placards:
As indicated in the Q&A above, no placard exists for Division 6.2 Infectious Substances; so obviously no placards can be displayed on a motor vehicle or a bulk packaging no matter the amount of Division 6.2 Infectious Substance. In fact, if a motor vehicle contains only non-bulk packagings of Division 6.2 Infectious Substances – UN2814, UN2900, UN3373, or UN3291 – then neither placards nor package marks are required to be displayed on the outside of the motor vehicle.
If, however, a bulk packaging of UN3291 displaying the BIOHAZARD package mark is transported in or on a motor vehicle where the mark is not visible, then §172.323 requires the motor vehicle to display the BIOHAZARD package mark on each side and each end.
Specifications for the BIOHAZARD package mark on a motor vehicle containing a bulk packaging of Regulated Medical Waste from §172.323:
Does this appear to be compliant with 49 CFR 172.323?
- It must measure at least 152.4 mm (6 inches) on each side.
- It must be visible from the direction it faces.
- The background color must be orange and the symbol and letters must be black.
- It must be displayed on a background of contrasting color.
- It may be displayed on a plain white square-on-point configuration having the same outside dimensions as a placard.
Q: But wait! Is the use of the BIOHAZARD package mark – which may be confused with a hazardous material placard – allowed?
A: Yes. §172.502(b)(2) specifically allows for the display of the BIOHAZARD package mark on a motor vehicle.
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I hope this article aided in your understanding of these complex regulations. Please contact me with whatever questions you have that remain unanswered.