On April 23, the National Solid Wastes Management Association's Medical Waste Institute (MWI), Washington, D.C., filed comments on a proposed federal rule for the transport of infectious substances.
At initial glance, the proposal is a mere update of existing infectious substances rules. However, proposed changes by the U.S. Department of Transportation (DOT), Washington, D.C., could be significant for waste disposal facilities and the healthcare industry. Most notable was the change on how to characterize medical waste to determine proper handling and packaging procedures. Characterization is a means of defining types of waste.
In the proposal, the DOT plans to use the World Health Organization's (WHO), Geneva, risk groups instead of the existing U.S. Center for Disease Control's (CDC), Atlanta, biosafety levels. The intent is to update U.S. regulations to match the standards used internationally, i.e., to ensure that U.S. companies can compete in the global market by using the same definitions.
However, the changes are not necessarily practical. The definitions may be the same, but the handling and packaging requirements are not. Additionally, most regulated medical waste generated in the United States is not exported.
The problem is that the rules on infectious substances do not distinguish between materials and waste. While the WHO risk groups do not make sense for the transport of regulated medical waste, they do for the import and export of infectious substances related to medicine and medical research where waste is not involved.
To comply with the change, every employee at all healthcare facilities and medical waste collection and disposal companies will need to be retrained, as will spotters and infection control managers at landfills. These facilities will need time to conduct training to ensure that compliance is not jeopardized.
Because the WHO risk groups are generally unknown to the waste business, MWI asked the DOT to increase compliance assistance. This includes developing and disseminating guidance documents and working with trade associations and trade press to alert the regulated community about the changes.
What are the proposed changes? The WHO risk groups are divided into four categories based on the potential for harm to individuals and communities:
Group 4 is for pathogens of diseases where there is no cure and preventive measures are not effective (high risk to individuals and the community);
Group 3 is for serious pathogens of diseases that are not ordinarily spread from one human to another (high risk to individuals, but low community risk);
Group 2 is for pathogens capable of causing serious disease where there is a cure and preventive measures, and the spread of the disease is unlikely (moderate risk to individuals, low risk to the community); and
Group 1 is for materials containing microorganisms that are unlikely to cause human or animal disease (low risk for individuals and the community).
Because risk group 1 rarely causes disease in humans, substances that fit into this category do not require packaging as regulated medical waste in the DOT's proposal. The majority of regulated medical waste will fall into risk groups 2 and 3. Because of the high risk, risk group 4 materials are treated at the point of generation and are unlikely to enter the waste stream.
These terms, however, are very general. In practice, a generator, the facility responsible for ensuring proper transport, must know what to do with wastes. A transporter and waste disposal facility must be able to know that the generator is in compliance to accept or reject a load. Therefore, bacteria, fungi, viruses, etc., are specifically listed under each risk group. The trick is getting a good list and knowing enough Latin to understand the lists.
The DOT references several websites in the proposed rule to obtain lists. All of them, either in comments to the agency or on the website, include disclaimers that the lists are not comprehensive or were developed for a limited purpose. The DOT also states in the proposed rule that it plans to work with the CDC and WHO to ensure that the regulated community has the necessary information to comply.
If the DOT cannot produce a comprehensive and understandable list, adopting the WHO risk groups will continue to be controversial. Regardless of training, generators and waste companies will continue to feel uncertain about compliance.
Alice P. Jacobsohn is the manager of NSWMA's Medical Waste Institute, and acting director of Industry Research and Public Affairs. Contact the author at (202) 244-4700 or at [email protected].