The Basics of Medical Waste Regulation
November 19, 2019

RMW or regulated medical waste is an infectious medical waste or biohazardous waste and is the waste that is contaminated by body fluids, blood, or potentially infectious materials. These materials pose a significant risk of transmitting infections.

Definition of Medical Waste

There is not a universal definition of medical waste, what is out there is offered by regulatory agencies, and they are very similar. Federal and state agencies have different meanings for common medical waste and those that have the potential for causing infections and need special handling. Most medical waste is broken down into:

  • Biomedical wasteThis form of waste contains potentially infectious or infectious materials. This waste is generated by biological and medical activities and sources, such as the treatment of diseases, diagnosis, or prevention. Types of biomedical waste include human tissues, organs, or other body parts. It can also come from animal waste generated through research, microbiology wastes, hypodermic needles, syringes, scalpels, and broken glass. These wastes can also include discarded medicines and cytotoxic drugs. 
  • Regulated wasteThese wastes are the liquids or semi-liquids and other potentially contaminated items that would release contaminated materials or blood in a semi-liquid or liquid state. It can include items that are caked in dried blood or other infectious materials. 
  • Infectious wasteThis form of waste is a subcategory of the broader medical waste stream, and includes, but is not limited to stocks of infectious agents, cultures, pathological wastes, human blood and blood products. It can consist of sharps used in animal and human care, dialysis waste, and laboratory waste. 

These are the medical wastes that are commonly regulated by states:

  • Pathological waste which includes body fluids, body parts, organs, and tissues
  • Human blood and blood products include plasma, blood products, serum, and waste blood
  • Stocks of infectious agents and cultures which are the specimens from medical and pathology labs, including culture dishes, and the devices used to transfer, mix, and inoculate
  • Contaminated sharps which include scalpel blades, broken glass, Pasteur pipettes, syringes, and hypodermic needles
  • Isolation waste is generated by patients in a hospital that protects others from infectious diseases
  • Contaminated animal carcasses, bedding, body parts that have come from animals that have been exposed to pathogens in biologicals production, in vivo pharmaceutical testing, and research

A basic definition of medical waste can be generalized as waste, which is a result of patient diagnosis or treatment or the immunization of animals and humans. The descriptions were created by a consensus of regulatory agencies such as EPA (Environmental Protection Agency), DOT (Department of Transportation), OSHA (Occupational Safety and Health Administration), along with local and state agencies. Regulated Medical Waste is that which contains enough blood or infectious materials that could potentially spread bloodborne pathogens.

Medical waste is not just from hospitals or industrial facilities; it can also be generated in medium and even small size businesses. While a small business may be a low volume producer, you are still required to follow all state and federal laws regarding the disposal of regulated medical waste. Businesses or facilities included are:

  • Tattoo Parlors
  • Body Art Parlors
  • Doctor Clinics
  • Dental Clinics
  • Veterinary Clinics and Hospitals
  • Clinical Laboratories
  • Pharmaceutical Companies

Does Medical Waste Have to Be Handled as a Hazardous Waste?

The RCRA (Resource Conservation and Recovery Act) is a federal law that decides which categories of waste will be handled as hazardous waste. This act also created the standards for how these wastes will be managed by facilities. The RCRA determined that medical waste is a hazardous waste and is therefore regulated in how it is handled, stored, and treated.

If you have questions regarding how your medical waste should be handled, check with your local hazardous waste disposal service for your county and state requirements. This service will also be able to advise you on the requirements you need to comply with regarding DOT, EPA, and OSHA as well, so you avoid potentially heavy fines.

Disposal of Medical Wastes

Most states require that medical waste be rendered non-infectious before it can be disposed of as solid waste. Regulated medical waste presents several challenges when disposing of it and remaining in compliance with state and federal regulations.

Unlike other regulations that are imposed on healthcare, most of the rules governing medical wastes are defined by the different states instead of the federal government. This regulation adds a level of complexity for medical wastes as rules often come from multiple agencies when handled at the state level.

Federal law does not provide an exact definition of medical waste; however, state departments of health have regulations that determine which medical wastes are ‘regulated’ and which require special handling. It is not always clear which direction to go with your medical waste when disposal methods are considered. You should check with your local hazardous waste disposal service for the specific rules that apply to your wastes.

The Environmental Protection Agency (EPA) played a significant role in developing a system of medical waste disposal regulations in the 1980s. They created a pattern similar to other forms of environmental laws, such as solid waste and air emissions. This framework that was created was then used on the federal level. States applied relatively minor variations to these rules.

After the initial phase of this program, a regulatory framework was created for medical waste that was different from the typical pattern and left each state with more discretion on its own regulations. The public was becoming more aware that syringes and other wastes were being discovered as ‘wash-ups’ on several East Coast shores. This issue caused Congress to enact a Medical Tracking Act, which required the EPA to develop a two-year medical waste program.

The EPA no longer has a central role in medical waste regulation. States and federal agencies have taken over the role and responsibility.

Medical Waste Regulations by States

Almost every state has medical waste regulations. Medical wastes are different from state hazardous waste regulations. State hazardous waste regulations are based on RCRA standards, while state medical waste standards vary considerably. Some of the state medical waste rules follow the Medical Waste Tracking Act, and others have absolutely no resemblance to this law.

The EPA is primarily responsible for creating and enforcing regulations for medical waste disposal and management. Some states have the department of health play an important role or even perform as the primary regulatory agency. When both agencies get involved, the department of health is typically the one responsible for on-site management, and the EPA oversees the disposal and transportation regulations.

States have regulations in place that cover transporting, storing, and packaging of medical waste. Some states require health care facilities to obtain or register a permit for disposing of medical waste. Check with your local hazardous waste disposal service about securing a permit for your medical waste disposal.

Medical Waste and OSHA Regulations

OSHA (Occupational Safety and Health Administration) regulates several areas of medical waste. They also regulate the management of sharps, set forth the rules for sharps containers, stipulate how medical waste bags and containers are labeled, and how you train your employees on medical waste handling.

The standards set forth by OSHA were created to protect healthcare workers from the risks possible when exposed to bloodborne pathogens. Their regulations also help to manage wastes to benefit the environment and the public systematically.

Disease transmission from contaminated sharps poses a significant threat to those administering treatment inside the clinical environment. OSHA estimates more than five million workers in the healthcare industry and related occupations are at risk for exposure to bloodborne pathogens from sutures, hypodermic needles, scalpels, blood collection devices, sharp devices, or phlebotomy devices.

The public becomes at risk when medical waste is not adequately separated and disposed of according to state and federal laws. These infectious and toxic wastes can end up in landfills. Generators of medical waste must know and understand proper disposal regulations, or they face substantial financial consequences.

In some cases or states, there are often overlaps between the department of health rules and state environmental rules and also the OSHA bloodborne pathogens standards. These overlaps rarely cause any conflicts, though, instead, where one set of rules may be vague, the other is more specific. In situations such as this, healthcare facilities are advised to follow the more stringent or detailed rules. If a state should not have a comprehensive medical waste regulation, the OSHA rules fill in the gap.

Medical Waste and US EPA Regulations

The EPA does not play a significant role in medical waste management; it does have an active role in governing emissions from medical/hospital/infectious waste incinerators. It also plays a role in the requirements for certain medical wastes under FIFRA (Federal Insecticide, Fungicide, and Rodenticide Act) that uses chemicals for treating wastes.

Medical Waste and DOT Regulations

Regulated medical waste is considered hazardous material under the DOT (Department of Transportation) rules. Their rules apply to transporters of the material rather than the healthcare facilities. As a generator of medical waste material, it is important you understand their rules as there is liability associated with shipping waste off-site. Check with your hazardous waste disposal service to ensure they are complying with all regulations.

What is Not Regulated Medical Waste?

Healthcare facilities need to understand the key concepts of regulated medical waste to avoid improperly segregating their waste. A common misunderstanding of these materials is the use of ‘saturated’ when describing a medical waste material.

Saturated typically means it falls under OSHA bloodborne pathogen guidelines, meaning the material is contaminated and would release blood or other potentially infectious materials in a semi-liquid or liquid state if it should become compressed.

The misinterpretation occurs when it is assumed that any medical product that will come into contact with body fluids, blood, or other infectious material is an automatically regulated medical waste. OSHA’s definition of ‘saturation’ does not allow most items with only trace levels of contamination to be put into a solid waste stream.

Check with your local hazardous waste disposal service to see which of your medical waste would not be considered regulated.


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