Understanding medical waste regulations

Medical waste can come with several regulation challenges when being transported or processed.

Most state laws require RMW to be rendered noninfectious before it can be disposed of as solid waste. RMW is unique to the health care sector and presents several compliance challenges. Unlike many regulations that apply to health care, most regulations governing medical waste are defined at the state rather than the federal level. Adding yet another layer of complexity, medical waste rules are often drafted from multiple agencies within a state.

Federal law does not provide an explicit definition of medical waste. Typically, state departments of health issue the regulations that determine which wastes are considered regulated or require special handling. Finding the definitions that apply in a company’s home state and the state they may be transporting waste to are critical in determining if this is a viable service line.

Beyond state regulations, the Health Insurance Portability and Accountability Act of 1996 (HIPAA) can also affect waste regulations if the patient’s name and one other piece of identifying information—such as a birth date, medical record number, patient number, etc.—are on a piece of waste.

Because of all the variables governing medical waste legislation, it is not always clear how regulations will apply to a specific situation. In the late 1980s, when the present system of medical waste regulation was being developed, the U.S. Environmental Protection Agency (EPA) played a major role. A generalized framework was developed on a federal level and was then adopted, with relatively minor changes, in each state. However, after that initial phase, the regulatory framework for medical waste developed, with considerably more discretion being left to individual states.

Providing a model

During the 1980s, there were several instances where used syringes and similar sources of medical waste washed up along beaches on the East Coast. In response to these events, Congress enacted the Medical Waste Tracking Act (MWTA), which required the EPA to create a two-year medical waste tracking program.


  • identified which wastes would be regulated;
  • established a cradle-to-grave tracking system based on a generator-initiated tracking form;
  • required management standards for segregation, packaging, labeling and storage of the waste;
  • established record-keeping requirements; and
  • defined penalties that could be imposed for mismanagement.

These standards for tracking and management of medical waste were in effect in four states (New York, New Jersey, Connecticut and Rhode Island) and Puerto Rico from June 1989 to June 1991. During this time, EPA also gathered information and performed several studies related to medical waste management. The regulations created under the MWTA expired on June 21, 1999.

From the information gathered during this period, EPA concluded that the disease-causing potential of medical waste is greatest at the point of generation and naturally tapers off after that point. Medical waste could, therefore, be considered more of an occupational concern than an environmental concern affecting the public.

The MWTA, along with EPA’s associated program, served to focus attention on the issue of medical waste. It also provided a model that was subsequently used by some states and by other federal agencies in developing their own medical waste programs. EPA no longer plays a central role in medical waste regulation; instead, the states and other federal agencies have taken on that responsibility. The following summarizes the current regulatory scheme for medical wastes.

State regulations

Nearly all 50 states have enacted medical waste regulations to some extent. However, unlike state hazardous waste regulations, which are all based on the federal Resource Conservation and Recovery Act (RCRA) standards, state medical waste standards vary significantly. Some state medical waste rules are fashioned after the MWTA, while others bear little to no resemblance to this historical law.

In most places, the state EPA is primarily responsible for developing and enforcing regulations for medical waste management and disposal. Although in some states, the department of health may play a leading role (e.g., Missouri and Oklahoma) or even serve as the primary regulatory agency, such is the case in Colorado. Where both agencies are involved, like in Louisiana and Missouri, typically the department of health is responsible for on-site management and the environmental agency is responsible for transportation and disposal.

Most states have regulations covering packaging, storage and transportation of medical waste. Some states require health care facilities to register and/or obtain a permit for their waste. State rules may also cover the development of contingency plans, on-site treatment, training, waste tracking, recordkeeping and reporting.

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OSHA regulations

The U.S. Department of Labor Occupational Safety and Health Administration (OSHA), and affiliate organizations in 24 states that operate their own program, regulate several aspects of medical waste. These areas include management of sharps, requirements for containers that hold or store medical waste, labeling of medical waste bags/containers, and employee training. These standards are designed to protect health care workers from the risk of exposure to bloodborne pathogens. However, they also help to systematically manage wastes, which benefits the public and environment.

In states with comprehensive medical waste regulations, there are often overlaps between state EPA/department of health rules and the OSHA bloodborne pathogens standard; however, there are few, if any, conflicts. Where one set of rules may be vague or general, the other may be highly specific. In such cases, health care facilities are advised to follow the more detailed or stringent regulations. In states where comprehensive medical waste regulations do not exist, the OSHA rules fill an important gap.

EPA, DOT and CDC regulations

Although EPA no longer plays a central role with medical waste management like it once did, the organization has active regulations governing emissions from hospital/medical/infectious waste incinerators. There are also specific requirements under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) for certain medical waste treatment technologies that use chemicals for treating the waste.

Regulated medical waste is defined by the Department of Transportation (DOT) as a hazardous material. The DOT rules mostly apply to transporters rather than health care facilities; although, knowledge of these rules is important because of the liability associated with shipping waste off-site. In addition, the Centers for Disease Control (CDC) issues guidelines for infection control.

Regardless of which state a medical facility may be located in, knowing and adhering to proper medical waste regulations and legislation protocols can help protect operators from illness, injury or enforcement.

Note: Some information for this article was obtained, with permission, from the Healthcare Environmental Resource Center at www.hercenter.org/rmw/rmwoverview.php.

Tom Dumez is the president of Prime Compliance based out of Grand Rapids, Michigan. He is a certified HIPAA professional and certified security compliance specialist. Tom can be contacted at tdumez@thehipaaman.com.

Regulated medical waste (RMW), also known as biohazardous waste or infectious medical waste, is the portion of the waste stream that may be contaminated by blood, body fluids or other potentially infectious materials, thus posing a significant risk of transmitting infection. There are several categories of waste that are typically classified as RMW, and each category has special handling requirements.

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