2014 proved to be a very interesting year concerning regulatory updates governing the transport of infectious, biological, and related materials. In the U.S, two regulatory changes involving hazard labels took effect, but with distinctly different outcomes. This article focuses on the process for regulatory changes, and also reviews these recent changes and their effect on shipments of infectious substances, biological specimens, and related materials.
In the U.S., the Department of Transportation (DOT) regulates the transport of all hazardous materials. Since infectious substances can cause disease in humans and animals if an exposure were to occur during transportation, they are considered hazardous materials. The Pipeline and Hazardous Materials Safety Administration (PHMSA, a branch of the DOT) oversees the creation, updating and enforcement of the Hazardous Materials Regulations (HMR) found in Title 49 of the Code of Federal Regulations (49 CFR). The 49 CFR outlines the regulatory requirements for the classification, identification, packing, marking, labeling, and documentation of shipments of hazardous materials within the U.S. One of these requirements is that all packages containing hazardous materials must display a hazard label communicating the classification, as well as the risks, of the hazardous materials contained within the package.
According to the classification criteria in the regulations, any substance that can cause disease or death in humans or animals must be shipped as a Division 6.2 hazardous material. Additionally, any package containing a highly pathogenic infectious substance must be labeled with a Class 6 infectious substance hazard label. This label is shaped as a diamond-on-point (a square, set at a 45ϒ angle) with the biohazard symbol placed in the top half, while the bottom half contains the text, “INFECTIOUS SUBSTANCE In Case of Damage or Leakage, Immediately Notify Public Health Authority.” The number 6 is included in the bottom corner of the label to indicate it is a Class 6 hazardous material (Figure 1).
| Figure 1. Class 6 infectious substance hazard label. |
Prior to 2011, the Class 6 Infectious Substance hazard label in the U.S. also contained the text “In U.S.A. Notify Director – CDC Atlanta, GA 1-800-232-0124.” However, the Centers for Disease Control and Prevention (CDC) requested that its information be removed from the label. This doesn’t mean that CDC is no longer involved with hazardous materials leakage or spill incidents, as many highly contagious pathogens are also controlled by the Select Agent regulations, and CDC must still be notified of any accidental spills or leaks of Select Agents. Essentially, the removal of the agency’s contact information from the Class 6 hazard label means that CDC now responds only to those infectious substance incidents where the infectious substance is also a Select Agent.
PHMSA complied with CDC’s request, and its information was removed from the hazard label. As many manufacturers pre-print the labels on their packages and many facilities had large inventories of the old labels and older Class 6.2 packages, PHMSA allowed a three-year grace period for the transition, permitting both labels to be used, until September 30, 2014. As this transition period has now ended, any packages still exhibiting the old label must be covered with the new label to remain compliant with current regulations.
Another label that was affected by recent regulatory changes is the Class 9 Miscellaneous Hazard label. Many infectious and biological substances are shipped using dry ice as a refrigerant, which is categorized as a Class 9 Miscellaneous hazardous material when transported. Therefore, packages containing dry ice must be labeled with the Class 9 Miscellaneous Hazard label (there are exceptions, but they are beyond the scope of this article). The Class 9 Miscellaneous Hazard label is also shaped as a diamond-on-point. It is white, with the top half containing seven vertical black lines and the number 9 in the point of the bottom half. (Figure 2)
| Figure 2. Class 9 miscellaneous hazard label. |
Prior to 2011, the U.S. Class 9 label also contained a horizontal line on the bottom of the black vertical stripes, at the center of the diamond. This difference caused package rejection outside of the U.S. For this reason and to alleviate confusion, the label was changed by PHMSA to harmonize with the worldwide label. This change was made in 2011, but again, there was a three-year grace period given during which either label could be used.
Dry ice is not the only hazardous material that falls under Class 9, and a number of companies felt that the new regulations would cause them a hardship, as they would not be able to meet the change prior to the deadline. These organizations approached an industry-based organization, COSTHA (Council on Safe Transportation of Hazardous Articles), and COSTHA petitioned PHMSA to request an extension beyond the September 30, 2014 deadline. PHMSA did not grant the requested extension. Instead, PHMSA changed its interpretation of the Class 9 Miscellaneous Hazard label by stating that the horizontal line dividing the top and bottom halves of the label does not affect the obvious meaning of the label and, therefore, should have no effect on the safe transport of the package. Because the line was deemed “optional” effective September 30, 2014, both Class 9 Miscellaneous Hazard labels are acceptable on shipments in the U.S. Nonetheless, it is important to keep in mind that the old label still does not meet the international regulations, so labs could still encounter rejection of international shipments. When shipping internationally, it is highly recommended to use the international label (the one without the horizontal line).
These two label changes provide excellent examples of the processes involved in regulatory updates. Although new regulatory changes usually proceed as outlined, occasionally additional amendments can occur, based on the needs of the organizations that would be affected the most by the regulatory change. The change in the Class 9 label also clearly demonstrates that PHMSA is willing to recognize the needs of the industry by adapting the regulations, provided safety is not compromised
