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May 1, 1999
Medical waste handlers may soon find the ground rules have changed as the United States considers adopting international standards for medwaste transportation.
The Department of Transportation (DOT) Research and Special Programs Administration (RSPA), Washington, D.C., has announced an advance notice of proposed rulemaking (ANPRM) called "Hazardous Materials: Revision to Standards for Infectious Substances and Genetically Modified Micro-organisms," which may result in stricter regulations on how medwaste is transported. Right now, U.S. medwaste handlers are governed by the Centers for Disease Control and Prevention (CDC), Atlanta, guidelines, but the proposed changes would "internationalize" U.S. regulations using World Health Organization (WHO), Geneva, Switzerland, standards, utilized by many other countries.
The proposed changes raise concerns for the industry, including a revised definition of infectious waste, new placard requirements and a "materials of trade exemption."
DOT would like to get the notice of proposed rulemaking (NPR) out before summer, but it may be delayed until later this year, says Eileen Edmonson Mack, RSPA regulations specialist.
"The nature of this work is that you could have a policy ready to go but the rule has to wait," she says. After the comment period for the ANPRM is over, DOT will prepare a NPR, which will be published in the "Federal Register" - where regulations established by the federal government's executive branch are recorded. After publishing the NPR, another period of public comment will follow before the proposed changes take effect.
DOT is evaluating approximately 75 responses on the ANPRM since the first public comment ended Dec. 1, 1998. The majority of the comments are from veterinarians, laboratories and university researchers, who are not in favor of the changes, Mack says.
Defining Infectious Part of the proposed rules involve DOT changing the definition of infectious waste to follow WHO risk groups, which define how to segregate, package and transport infectious substances and regulated medical waste (RMW). Right now, the U.S. uses CDC biohazard safety levels.
One of the arguments against the change is that access to the WHO manual that explains these risk groups is extremely limited, hindering the ability of rule makers to integrate these guidelines, according to the Medical Waste Institute (MWI) a component of Environmental Industry Associations (EIA), Washington, D.C.
"MWI was informed at its 1998 Compliance Conference that even the Hazardous Materials division of RSPA had difficulty obtaining a copy," says Alice Jacobsohn, MWI manager of waste programs. "Issuing the rule without a clear understanding of how it applies will lead to chaos in the management of infectious substances."
Another argument is that the CDC standards work well and there is no reason to change.
Ed Krisiunas, a Burlington, Conn.-based consultant, disagrees with both arguments, saying that access to the WHO manual is not the real problem, and that if WHO regulations provide a better way to manage and define RMW, why not use them?
One wrinkle, though, is that many states have their own medwaste definitions and regulations to suit their geographic and community needs, and these may conflict with federal regulations, he says. "Things will get really confusing on an international level."
Federal agencies will have preemptive authority, but it may take time for the communication to trickle down to the local level, Mack says.
Regardless, DOT is reviewing how to make WHO information more accessible, perhaps through a cooperative effort with CDC, Mack says. At this time, CDC has not commented on the ANPRM.
International Shipments? Mary Ellen Lynch, a Silver Spring, Md., consultant who submitted comments for Browning-Ferris Industries (BFI), Houston, questions the need for international WHO standards, asserting that the CDC standards are fine. BFI recently was purchased by Allied Waste Industries, Scottsdale, Ariz.
"You would be hard-pressed to find health care professionals who do not understand CDC standards," she says. "The No. 1 problem with [using the WHO standards] is that medwaste generally isn't transported internationally."
However, Mack points out that some air and vessel carriers adhere to the international regulations, even if they are shipping to Puerto Rico, Alaska and Hawaii.
"Even within the United States, [the regulations] may be necessary if handlers are sending material across Lake Erie by barge or on the Mississippi River," she says.
In addition, infectious substances such as AIDS viruses are shipped internationally for research.
Placard Problems Placarding also is an issue. Currently, vehicles transporting RMW are not required to carry placards, a form of hazard communication that must be visible from a distance. But, according to current DOT regulations, they must be marked with a biohazard symbol.
DOT proposes to change this, requiring that infectious substance placards be placed on transportation vehicles.
This presents a serious problem because of the associated routing restrictions and regulations for placarded vehicles, Lynch says.
States can restrict where and when such vehicles may travel, possibly preventing trucks from using bridges and tunnels, or traveling through "special population areas," Lynch says. This also may limit vehicles from entering neighborhoods where hospitals are located, she adds.
"It defeats DOT's own stated goal of getting RMW transported as quickly as possible to keep it from decomposing," she says.
"The real problem with RMW isn't that a truck will tip over and explode, or that materials will commingle - it's contact," she continues.
MWI agrees that the concern with medwaste is exposure to diseases, such as human immunodeficiency virus (HIV), or hepatitis B from direct contact, rather than ambient exposure.
A placard requirement also could lead to registrations, leading to additional burdens for an industry already hampered by high costs, Jacobsohn says.
Eventually these costs will be passed on to patients, further adding to health care costs.
It is difficult to say what restrictions might ensue, Mack says.
Currently, some states have placarding restrictions for vehicles that transport RMW or hazardous waste.
In Maryland, for example, if a vehicle requires placards, the driver must have a hazardous materials endorsement on the commercial driver's license. Also, Maryland and Virginia prohibit placarded vehicles from traveling through tunnels.
Conversely, Kansas has no such limits. "We do want it [RMW] marked in accordance with federal DOT requirements," says Ken Powell, environmental scientist with the Kansas Department of Health and Environment.
"But we look at medical waste as one thing that needs special handling - not handling as a hazardous waste," he says. "We try to avoid overregulating."
Materials of trade exemption DOT has planned a materials of trade exemption, which would regulate medical-related items carried in vehicles, but would exempt home health care entities.
"Even though hospital and health care facilities must handle and package waste properly, home health care workers would not have to meet those requirements," Lynch says.
The exemption, defined through standards for intrastate transportation of hazardous materials, actually took effect on Oct. 1, 1998.
However, some estimates indicate that up to 100 million pounds per year of medwaste is generated at home, and many in the industry are objecting to the exemption.
"With recent changes to health care, significant quantities of medical waste are being generated in the home and are being transported in the same vehicles that transport families and groceries," says Jacobsohn.
Eventually, home health care should be under the umbrella of DOT regulations, Krisiunas says. "If people are transporting medwaste, the bloodborne pathogens standard applies to them.
"We're seeing a shift to more home health care, and I don't think we have a good handle on the services being administered out there," he continues. "We may find there aren't any problems, but you can't say you don't have [problems] if you haven't studied it."
The exemption was written to bring lab couriers and other transporters under review. "The real issue here is that waste haulers or people who took blood samples for analysis previously were unregulated," Mack says.
Consequently, DOT wants to continue to put international transportation regulations into effect. And, Mack says, "We would like to reach out to states for comment."
Information on the proposed regulations is available on the DOT's Internet site: http://dot.dms.gov
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