Regulated Medical Waste — Overview
What is RMW?
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 key categories of waste that are typically classified as ‘regulated’. Each category typically has special handling requirements that may be state-specific. See the Types of Regulated Medical Waste page for more information on the classification of RMW
Most state laws require RMW to be rendered non-infectious before it can be disposed of as solid waste. (See the RMW Treatment and Disposal page for more information.)
RMW is unique to the healthcare sector and presents a number of compliance challenges. Unlike many regulations that apply to healthcare, most regulations governing medical waste are defined at a state, rather than a federal level. Adding yet a further level of complexity, authority for medical waste rules often comes from multiple agencies at the state level. (See below.)
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. Use the RMW State Locator to find the definitions that apply in your state.
Of course, it is not always clear how overall rules will apply to a specific situation. The RMW State Locator provides contact information for individuals in state agencies who may help resolve questions of interpretation.
Regulatory Overview—Past
In the late 1980s, when the present system of medical waste regulation was being developed, EPA played a central role. The pattern was similar to other forms of environmental regulation, such as air emissions and solid waste. A general framework was developed on a federal level, and was then adopted, with relatively minor variations, in each state. However, after that initial phase, the regulatory framework for medical waste developed differently from the more typical pattern, with considerably more discretion being left to individual states.
During the 1980’s, the public became aware that used syringes and similar wastes had been found washing up on several East Coast beaches. In response, Congress enacted the Medical Waste Tracking Act (MWTA), which required EPA to create a two-year medical waste demonstration program. The MWTA:
-
identified which wastes would be regulated
-
established a cradle-to-grave tracking system based on a generator-initiated tracking form (similar to RCRA manifests for hazardous waste)
-
required management standards for segregation, packaging, labeling, and storage of the waste
-
established record-keeping requirements
-
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, Rhode Island), and in Puerto Rico, from June 1989 to June 1991. During this time, EPA also gathered information and performed several studies related to medical waste management.
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 general public: the risk to the general public of disease caused by exposure to medical waste is likely to be much lower than the risk for the occupationally exposed individual.
The MWTA, along with EPA’s associated program, served to focus attention on the medical waste issue. It also provided a model that was subsequently used by some states and by other federal agencies in developing their own medical waste programs.
Regulatory Overview—Present
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 Medical Waste 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 RCRA standards, state medical waste standards vary diversely. Some state medical waste rules are fashioned after the Medical Waste Tracking Act, while others have little or no resemblance to this historical law.
In most states, the environmental protection agency is primarily responsible for developing and enforcing regulations for medical waste management and disposal. Although in some states, the department of health may play an important role (e.g., MO, OK) or even serve as the primary regulatory agency (e.g., CO). Where both agencies are involved, typically the department of health is responsible for on-site management and the environmental agency is responsible for transportation and disposal (e.g., LA, MO).
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. State rules may also cover the development of contingency plans, on-site treatment, training, waste tracking, recordkeeping, and reporting.
OSHA Regulations. OSHA, whether it is the U.S. Department of Labor Occupational Safety & Health Administration or an OSHA state program (24 states operate their own program), regulates several aspects of medical waste, including 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 healthcare workers from the risk of exposure to bloodborne pathogens. However, they also help to systematically manage wastes, which benefit the public and environment.
In states with comprehensive medical waste regulations, there are often overlaps between state environmental/department of health rules and the OSHA bloodborne pathogens standard; however, there are few, if any conflicts. Instead, one set of rules may be vague or general, where the other is highly specific. In such cases, healthcare 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.
US EPA Regulations. Although EPA no longer plays a central role with medical waste management, EPA has active regulations governing emissions from Hospital/Medical/Infectious Waste Incinerators as well as requirements under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) for certain medical waste treatment technologies which use chemicals for treating the waste.
DOT Regulations. Regulated medical waste is defined by the Department of Transportation as a hazardous material. The DOT rules mostly apply to transporters rather than healthcare 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.
What is not RMW?
While states do outline specific categories of regulated medical waste, it is important that healthcare facilities understand certain key concepts to avoid improper segregation of wastes.
One common misunderstanding, for example, is the use of the word ‘saturated’ to define what material can be considered solid waste versus RMW. In some states, ‘saturated’ typically refers back to the OSHA blood borne pathogen standard, which qualifies the meaning of 'saturated' as referring to “contaminated items that would release blood or other potentially infectious materials in a liquid or semi-liquid state if compressed”.
In those cases, it would be a misinterpretation is to assume that any medical product that comes into contact with blood, body fluids or other potentially infectious materials, no matter how minor the contact, automatically becomes RMW. The OSHA ‘saturation’ definition would allow most items with trace levels of contamination to be placed in the solid waste stream.
Your state's rules may allow you to handle certain wastes that you currently handle as medical wastes as part of the general solid waste stream. Check the RMW State Locator for details on your state's definitions.
