Regulated Medical Waste
Definition of Infectious
An infectious waste is
any used material which is: generated in the health care community
in the diagnosis, treatment, immunization, or care of human beings;
generated in autopsy or necropsy; generated in research pertaining
to the production of biologicals which have been exposed to human pathogens;
generated in research using human pathogens. Examples include: sharps;
specimens, cultures, and stocks of human pathogenic agents; blood and
blood products; pathological waste; contaminated animal waste; and
isolation waste. Also, any material designated by written generator
policy as infectious, or any other material designated by a generator
as infectious by placing the material into a container labeled infectious
is an infectious waste. In addition, any solid waste which is mixed
with infectious waste becomes designated as infectious and must be
managed unless expressly excluded.
Certain wastes are excluded
from the definition of infectious waste such as infectious waste residues
resulting from discharges, hazardous waste which is to be managed pursuant
to the hazardous waste management regulations, radioactive material
which is managed pursuant to the department regulation, infectious
wastes generated in a private residence except when determined by the
commissioner to be an imminent or substantial hazard to public health
or the environment.
The Department will determine how individual
waste fits into the definitions and/or categories.
All in-state generators of infectious waste
must register with the Department of Health and Environmental
Control. Information to be given should include the name of
the business, name of the owner and responsible party if different,
physical location of the site of waste generated, mailing address
of the site of generation, telephone number of the site, a contact
name of the infectious waste coordinator, and the categories
and amount of infectious waste generated annually (estimated
within + or -20%).
When any changes occur in the information
required the Department must be notified in writing of such changes
within thirty (30) days.
Renewal of registration will be every three
(3) years for all generators. Registered generators will be notified
of renewal requirements by the Department.
Fees for registration are due at the time
of registration and renewal.
Each generator must have a designated infection
control committee with the authority and responsibility for infectious
waste management. This committee must develop or adopt a written
protocol to manage the infectious waste stream from generation
to disposal. The written protocol must include contingency plans
and a Quality Assurance program to monitor their own onsite treatment
procedures. Small quantity generators are not required to have
an infection control committee or a written protocol.
All in-state generators that produce less
than fifty (50) pounds of infectious waste per calendar month
are small quantity generators and are exempt from some of
the provisions of this regulation. (see complete regulations
Generators who qualify as small quantity
generators, as defined above, may transport their own waste provided
they never transport more that fifty pounds at a time, the waste
is packaged and labeled as required and the waste is not transported
in the passenger compartment of the vehicle and is in an enclosed
compartment to protect the container from inclement weather.
If a small quantity generator offers infectious
waste for transport offsite for treatment at a destination facility,
the waste must be appropriately managed (e.g., segregated, packaged,
Generators must segregate infectious waste
from solid waste as close to the point of generation as practical
to avoid commingling of the waste. If infectious waste is put in
the same container as other waste, or if solid waste is put into
a container labeled as infectious waste, the entire contents of the
container must be managed as infectious waste unless hazardous and/or
radioactive material regulations apply, then the most stringent regulations
Generators must assure that infectious
waste is properly packaged before transporting or offering for
transport offsite; must place and maintain all sharps in rigid,
leak resistant, and puncture resistant containers which are secured
tightly to preclude loss of the contents and which are designed
for the safe containment of sharps; all other types of infectious
waste must be placed, stored, and maintained before and during
transport in a rigid or semi-rigid, leak proof container which
is impervious to moisture.
Containers must have sufficient strength
to prevent bursting and tearing during handling, storage, or
transportation. They must be sealed to prevent any discharge
of the contents at any time until the container enters the treatment
Plastic bags used inside of containers
must be a red or orange color and have sufficient strength to
Dumpsters, trailer bodies or other vehicle
containment areas do not constitute a rigid containment system
but are only a transport mechanism.
Infectious waste must be contained in disposable
or reusable containers that are appropriate for the type and
quantity of waste, must withstand handling, transfer, and transportation
without impairing the integrity of the container, must be closed
tightly and securely, and must be compatible with selected storage,
transportation, and treatment processes.
Reusable containers are acceptable. These
containers must be properly disinfected after each use.
Infectious waste must not be compacted
by any means prior to entering the containment of the treatment
Exempt or excluded waste must not be packaged
as infectious waste. Waste packaged as infectious waste must
be managed as infectious waste.
When infectious waste is treated by a technology
which does not change the appearance of the bag or outer container,
it must be clearly labeled with the word “Treated” and the date
of treatment on the outside of the container to indicate that
the waste was properly treated. This labeling method may be hand
written, an indicator tape or chemical reaction. The labeling
process must be water-resistant and indelible.
Labeling of Containers.
Generators and transporters must assure
that containers of infectious waste are properly labeled in English.
Containers of infectious waste offered
for transport offsite must be labeled on outside surfaces with
water-resistant and indelible ink so that it is readily visible
with the universal biohazard symbol, the name or Department issued
number of the in-state generator, and the name, address and phone
number of the in-state generator if the waste is generated outside
of this state. The date the container was placed in storage
or sent offsite and the words Infectious Waste, Biohazardous
Waste, or Medical Waste must be noted.
Each bag used to line the inside of an
outer container must be labeled with indelible ink or imprinted
Transporters must label each outer container
at the time it is accepted as specified and must affix required
labels so that no other required markings or labels are obscured.
Abbreviations may not be used in required
labeling except for the common dictionary standard abbreviations.
Storage of Infectious
Storage must be in a manner and location
which affords protection from animals, vectors, weather conditions,
theft, vandalism and which minimizes exposure to the public.
Outdoor storage areas must be locked (for
example: dumpsters, sheds, trailers, van bodies, or any other
Storage areas must be labeled with the
universal biohazard symbol sign and the words Infectious Waste,
Medical Waste, or Biohazardous Waste.
Infectious waste must be maintained in
a nonputrescent state using refrigeration when necessary.
All floor drains in storage areas must
discharge into a Department approved sanitary sewer system or
be transported to a Department approved sewerage treatment facility
or permitted infectious waste treatment facility.
All ventilation in storage areas must be
in compliance with applicable Department air quality requirements
and minimize human exposure.
Any material or surface which comes in
contact with infectious waste must be disinfected prior to reuse.
Disinfection can be accomplished by appropriate
use of an EPA registered disinfectant used according to the label
instructions at the tuberculocidal strength.
Drainage from decontamination processes
must discharge to a Department approved sanitary sewer system
or be transported to a Department approved sewerage treatment
facility or permitted infectious waste treatment facility.
Requirements for Generators
A generator who transports, or offers for
transport, infectious waste for offsite treatment, storage, or
disposal, must prepare a manifest on a form approved by the Department
and filled out in a legible manner according to the instructions
for that form. The manifest form must accompany the waste at
all times after leaving the generator's facility.
The generator who offers regulated infectious
waste for transport offsite must initiate the manifest required
and must also sign where required.
- The generator must retain one
copy of the manifest after the transporter has signed accepting
the shipment and must notify the Department in writing if he does
not receive a completed manifest appropriately signed from the
destination facility within fifty days after offering for transport.
Treatment of infectious waste must be by one of the
following treatment methods:
Approval for other forms of treatment must be obtained
from the Department and meet standards set at that time by the Department.
After approved and adequate treatment, the waste
residue may be disposed of in accordance with state and federal solid
The following infectious waste may be disposed of
An approved liquid or semi-liquid waste other than
microbiological cultures and stocks may be discharged directly into
a Department approved wastewater treatment disposal system; and
Recognizable human anatomical remains may be disposed of by interment
or donated for medical research.
Products of conception must be incinerated, cremated,
interred, or donated for medical research.
Storage of infectious waste prior to treatment must
be in accordance the regulations.
It is unlawful for any person to discharge infectious
waste or treated infectious waste into the environment of this State
except as permitted by the Department.
Small quantity generators may treat, by an approved
method onsite, infectious waste which they generate onsite without
being permitted as a treatment facility.
Treatment of infectious waste must be monitored by
use of biological indicators or laboratory culture of the treatment
residue to ensure that pathogens have been adequately treated. Frequency
of this testing shall be determined by the Department on a case by
case basis or as outlined in this regulation.
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. South 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
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