North
Carolina
Regulated Medical Waste
Background Information
- Which waste stream should this waste material
go into?
- How do I manage Regulated Medical Waste?
- What will happen with the Regulated Medical Waste
stream?
- Where can I get more information?
Background Information
Medical waste differs from hazardous waste. Hazardous waste is regulated by the US EPA (and related state rules) under the Resource Conservation and Recovery Act. Medical waste is not covered federal environmental laws or US EPA regulations (with the exception of a medical waste that also meets the definition of hazardous waste). Rather, medical waste is mostly controlled by state law and associated regulations. In addition to state environmental agency laws/rules, aspects of medical waste management are also controlled by the Occupational Safety & Health Administration (federal and/or state) and Department of Transportation (federal and state).
Each of our 50 states have developed rules and implemented regulations for medical waste. The state rules vary to some extent, including terminology. Depending on which state you live in, you may hear the terms regulated medical waste, biohazardous waste or infectious medical waste. In most cases, these terms all refer to the same thing: that portion of the medical waste stream that may be contaminated by blood, body fluids or other potentially infectious materials, thus posing a significant risk of transmitting infection.
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.
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 or even serve as the primary regulatory agency. 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.
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.
Regulated medical waste is defined by the US Department of Transportation as a hazardous material. 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.
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:
