On June 2, 2006, the U.S. Department of Transportation's (DOT) Pipeline and Hazardous Materials Safety Administration (PHMSA) published a final rule on infectious substances. (Labeled HM-226A, the final rule can be found in the Federal Register, volume 71, pages 32244 through 32263.) The new rule changes the classification system for infectious substances from the World Health Organization's (WHO) Risk Groups 1 through 4 to WHO Categories A and B.
The National Solid Wastes Management Association's Medical Waste Institute (MWI) commented on the proposed rule, which was published on May 19, 2005. The effective date stated in the rule is Oct. 1, 2006; however, compliance may begin as soon as July.
Prior to summer 2002, DOT used the U.S. Center for Disease Control's (CDC) Biohazard Safety Levels to determine how different infectious substances should be packaged and shipped on U.S. highways. The problem with the level system was that it was designed to help laboratories handle the materials and did not take into consideration transportation issues, such as highway conditions.
Additionally, the system was designed by a U.S. organization and was not internationally based. While medical waste in the United States generally does not cross international lines, other forms of infectious substances regulated under the same rules do.
In a final rule published in August 2002, DOT changed the classification system to one published by WHO that placed infectious substances into four risk groups based on their potential danger of spreading disease to individuals and communities. DOT thought that using an international standard would be better. However, once again, the risk groups were developed only for the purposes of laboratory management.
Once the final rule was published, the regulated community ran into some difficulty in understanding how to comply. WHO, not pleased that its laboratory risk groups would be used for transportation, began developing a new system specific to transportation. PHMSA has adopted this new system.
Generally, Category A is for higher risk materials than those in category B and requires packaging consistent with UN 2814 (the international number given to identify infectious substances affecting people) and UN 2900 (for substances affecting animals). Category B is for substances in the UN 3373 (diagnostic specimens) and UN 3291 (regulated medical waste) groups.
The packaging requirements within the new classification system do not change significantly. However, some substances that would otherwise be regulated as medical waste under Category B may now be in Category A if transported as a culture or stock. The definition for cultures now reads, “Cultures are the result of a process by which pathogens are intentionally propagated by use of ideal conditions, including temperature, environment and nutrient-based propagation media.”
Category A outer packaging must be rigid. In addition, Category A infectious substances may not be transported in a wheeled cart of bulk packaging. Substances that also are select agents (listed in Title 9, Part 121 Code of Federal Regulations, which was developed by CDC and the U.S. Department of Agriculture) have been added to the requirements on packaging and shipping.
Other changes to the rules include clarifying the requirements for sharps containers. PHMSA believes that many of the closures on existing sharps containers are not adequate to comply with the “leakproofness” requirements contained in DOT's or OSHA's rules.
In its comments on the proposed rule, MWI said that the language on the requirements was not sufficiently clear. PHMSA accepted MWI's point. In the final rule, sharps containers must be securely closed to prevent punctures or leakage during transportation in accordance with the instructions provided by the packaging manufacturer.
Alice Jacobsohn is director of the Medical Waste Institute for the Washington-based National Solid Wastes Management Association. Contact the author at [email protected].