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North Carolina

Regulated Medical Waste

 

Which waste stream?

In this section, you will find information that will help you determine how various types of healthcare facility waste are classified in North Carolina.

Waste Categories

North Carolina classifies wastes generated by health care facilities into four main categories:

  • Hazardous wastes. This refers to a class of wastes specifically defined in a federal law (the Resource Conservation and Recovery Act, or RCRA).   These wastes contain certain toxic chemicals or have certain characteristics that cause them to be a significant risk to the environment and/or human health. Certain some chemotherapy waste is hazardous waste. In North Carolina, hazardous waste regulations are enforced by the North Carolina Department of Environment and Natural Resources (NC DENR).
  • Medical waste. Medical waste means any solid waste which is generated in the diagnosis, treatment, or immunization of human beings or animals, in research, or in the production or testing of biologicals. It does not include any hazardous waste, radioactive waste, or household waste.
  • Regulated medical waste (RMW). These are a special subcategory of medical wastes that present significant health risks such as the potential for infectious disease transmission, and special rules apply to them. In North Carolina, RMW is defined in general as "blood and body fluids in individual containers in volumes greater than 20 ml, microbiological waste, and pathological waste that have not been treated pursuant to specific standards. However, if a waste has been designated as a "hazardous waste" by the NC DENR, the hazardous waste rules apply. (Refer to the regulation for details).
  • Municipal solid waste.  These wastes present fewer environmental or health risks than medical wastes. Municipal solid waste can be disposed of into dumpsters.

It is important that you categorize your facility's waste accurately.

  • Hazardous waste disposed of as regulated medical waste or municipal solid waste, or regulated medical waste disposed of as municipal solid waste are violations of the law and can result in substantial penalties.
  • Conversely, most medical waste may be handled as general solid waste and does not require special handling or treatment.
  • Correctly identifying and segregating your RMW can reduce the cost of disposal. Regulated medical waste makes up only a small portion of the total medical waste stream. In North Carolina, roughly 9 to 15 percent of the waste stream at hospitals is regulated medical waste. Some facilities, such as long-term care facilities, generate medical waste, but little or no regulated medical waste. Use the guidance and references below to accurately categorize your wastes. For additional help, see Contacts below.
  • Regulated medical waste that is treated to specific standards can be disposed of as municipal solid waste, provided that no local rules prohibit it.

Definition of Regulated Medical Waste

"Regulated Medical Waste" means blood and body fluids in individual containers in volumes greater than 20 ml, microbiological waste, and pathological waste that have not been treated pursuant to specific rules (treatment requirements are covered under 1207 of the medical waste management rules).

Managing Regulated Medical Wastes

Requirements, for healthcare facilities that generate regulated medical waste and send it off-site to a treatment/disposal facility

Registration, Permits

Generators of regulated medical waste are not required to register with the state of North Carolina and no RMW generator permits are required by the state of North Carolina.  Also, permits are not required for hospitals and similar facilities that treat only waste generated within the facility. Permits are required for facilities that treat medical waste from off-site.

Packaging and Storage

  • Packaging of Regulated Medical Waste for Off-Site Treatment. There are certain specific rules that healthcare facilities must follow for packaging regulated medical waste. These include:
    • Regulated Medical Waste must be packaged in a plastic bag in a rigid fiberboard box or drum in a manner that prevents leakage of the contents.
    • The outer surface of the box or drum must be labeled with a biohazard symbol; the words "INFECTIOUS WASTE" or "MEDICAL WASTE"; the date of shipment; and the name, address and phone number of the generator, transporter, storage facility and treatment facility.
    • The medical waste management rules do not require a biohazard label on the plastic bag or use of red bags. However, generators should be aware that OSHA rules may require labeling of bags containing some types of medical waste.
  • Storage of Regulated Medical Waste Prior to Shipment Off-Site for Treatment. There are certain specific rules that health care facilities must follow for packaging regulated medical waste. These include:
    • A plan must be maintained at the facility to ensure proper management of regulated medical waste.
    • Areas used to store regulated medical waste must be accessible only to authorized personnel.
    • All medical waste, including regulated medical waste, must be stored in a manner so as not to create a nuisance either by noxious odors or by encouraging the presence of insects or vermin.
    • RMW must not be compacted.
    • Regulated medical waste that will be shipped off-site for treatment must be stored in packaging suitable for transportation and in a manner that maintains the integrity of the packaging, including labels and markings.
    • All floor drains in the storage area must discharge directly to an approved sanitary sewer (sewer or septic system).
    • Ventilation must be provided.
    • There are no maximum time limits for storage of RMW destined for off-site treatment.
  • Packaging Requirements for Regulated Medical Waste Which Will Be Treated On-Site. The packaging requirements only apply to regulated medical waste that is being shipped off site for treatment. There is no packaging requirement for regulated medical waste treated on-site.
  • Storage Requirements for Medical Waste Which Is Not Classified as Regulated Medical Waste. If none of the medical waste being stored is regulated medical waste, the waste is subject to the storage requirements of general solid waste. As with regulated medical waste, non-regulated medical waste must be stored in a non-putrescent state, and vermin and insects must be controlled.

Training Requirements

  • All employees involved with the on-site management of RMW must be trained in accordance with the requirements of the OSHA Exposure to Bloodborne Pathogens regulations (29 CFR 1910.1030).

Plans, Recordkeeping and Reporting

These rules apply to facilities that generate 50 pounds or more regulated medical waste per month.

Generators must prepare a plan to ensure proper management of regulated medical waste. The plan must be maintained at the generating facility. Generators must maintain records for each shipment of RMW. The records must include:

  • Amount of waste by number of packages,
  • Date shipped off-site,
  • Name of transporter, and
  • Name of storage or treatment facility.

There are no reporting requirements. However, these records must be maintained at the generatorÕs facility for at least three years.

Treatment and Disposal of Regulated Medical Waste

In this section, you will find information on the proper final disposition of the Regulated Medical Waste (RMW) stream, including RMW sent off-site and RMW treated on-site.

Regulated medical waste may be treated on-site or at a facility that is an integrated part of the generating facility (e.g., one or more healthcare facilities located in a single county or two contiguous counties, facilities affiliated with a university, or facilities that serve a single service area).

On-site Treatment Requirements

The following are acceptable methods for treating regulated medical wastes:

    • Blood and body fluids in individual containers in volumes greater than 20 ml: Incineration or sanitary sewage systems provided the sewage treatment authority is notified.
    • Microbiological waste: Incineration, steam sterilization, microwave treatment, or chemical treatment.
    • Pathological wastes: Incineration.

Other methods of treatment shall require approval by the NC Division of Waste Management (see Alternative Medical Waste Treatment Technologies.)

The following general rules apply to healthcare facilities that treat regulated medical waste:

  • Regulated medical waste may be stored prior to treatment for no more than seven calendar days and may be stored no longer than seven calendar days after treatment.
  • Only authorized personnel may have access to areas used to store RMW.
  • All areas used to store RMW must be kept clean. Vermin and insects shall be controlled.
  • Neither carpets nor floor coverings with seams may be used in storage areas.
  • Prior to treatment, all RMW be confined to the storage area.
  • All floor drains must discharge directly to an approved sanitary sewage system.
  • Ventilation must be provided and must discharge so as not to create nuisance odors
  • A plan shall be prepared, maintained and updated as necessary to ensure continued proper management of Regulated medical waste at the facility.
  • Records or treatment must be maintained for at least three years, including: each shipment and shall include the following information: name and address of generator, date received; amount of waste received by number of packages (piece count), date treated, and name and address of ultimate disposal facility.
  • Facilities that treat waste generated off-site shall submit an annual report to the Division of Waste management, by August 1 of each year.
  • Specific operational requirements for steam sterilization, incineration, chemical and microwave treatment requirements can be found in the Medical Waste Management Rules.

OSHA Regulations

In addition to the state medical waste environmental regulations there are some Occupational Safety and Health Administration (OSHA) rules that apply to medical/infectious waste. North Carolina is one of 24 states operating an approved occupational safety and health program. This program is operated by the Occupational Safety and Health Administration. OSHA rules (Occupational Exposure to Bloodborne Pathogens Standards) impact various aspects of medical/infectious waste, including management of sharps, requirements for containers that hold or store medical/infectious waste, labeling of medical/infectious waste bags/containers, and employee training. These requirements can be found in the HERC section entitled OSHA Standards for Regulated Waste.

More Information

In this section, you will find links to points of contacts at the North Carolina agencies responsible for regulating healthcare facility waste, links to the text of the regulations, and additional resources that you might find of interest on this topic.

Contacts

North Carolina Department of Natural Resources, Division of Waste Management.

Statutes, Regulations and Guidelines

Medical Waste Management Rules: Section 1200 -

Medical waste is also subject to all general requirements for solid waste found in the solid waste management regulations.

N.C. Hazardous Waste Section - Administers the RCRA Subtitle C program which regulates some types of waste from medical facilities including some chemotherapy waste.

Additional Resources

Medical Waste Guidance and Interpretations