Definition of Biomedical Waste
Managing Biomedical Waste
Statutes, Regulations and
Definition of Biomedical
is any solid or liquid waste which may present a threat of infection
to humans, including nonliquid tissue, body parts, blood, blood products,
and body fluids from humans and other primates; laboratory and veterinary
wastes which contain human disease-causing agents; and discarded sharps.
The following are also included:
- Used, absorbent materials saturated with blood,
blood products, body fluids, or excretions or secretions contaminated
with visible blood; and absorbent materials saturated with blood
or blood products that have dried; and
- Non-absorbent, disposable devices that have
been contaminated with blood, body fluids or, secretions or excretions
visibly contaminated with blood, but have not been treated by an
The Florida Department of Health (the Department)
has primary authority and responsibility for facilities that generate,
transport, store, or treat biomedical waste through processes other
than incineration. The Florida Department of Environmental Protection
(DEP) has primary responsibility for biomedical waste incineration
and final disposal.
All biomedical waste
facilities shall comply with the following:
- Biomedical waste mixed with hazardous waste
shall be managed as hazardous waste.
- Biomedical waste mixed with radioactive waste
shall be managed in a manner that does not violate the provisions
of and in accordance with radiation control regulations and packaging
- Any other solid waste or liquid, which is
neither hazardous nor radioactive in character, combined with untreated
biomedical waste, shall be managed as untreated biomedical waste.
- All surfaces contaminated with spilled or
leaked biomedical waste shall be decontaminated as part of the cleaning
Each biomedical waste
facility shall implement a written operating plan to manage biomedical
waste, and contain specific components as required by the regulations.
The plan shall be available for review by the department and facility
generators shall not negotiate for the transport of biomedical waste
with a person who is not registered with the department as a biomedical
of biomedical waste within the generating facility, except recognizable
human tissue, bulk liquids, or sharps, is acceptable provided the following
conditions are met::
- Packages of biomedical waste shall not be
compacted to a density greater than 22 pounds per cubic foot;
- Compacted packages of biomedical waste shall
not be subjected to further compacting;
- Any residual or incidental liquid shall be
contained within the inner bag or outer container. Should the inner
bag or outer container rupture during compaction, residual or incidental
liquids shall be disposed of directly into the sanitary sewer, an
on-site sewage treatment and disposal system, or other system approved
to receive such wastes by the DEP or the department;
- Discharge of noxious air shall be kept to
a minimum through use of HEPA filters having a pore size of 2 microns
or less, negative pressure rooms, or other safety methods; and
- Compacted packages of biomedical waste shall
be treated by incineration or other approved treatment process.
All biomedical waste facilities, except those
facilities operating under a DEP permit, shall obtain an annual permit
(there is a permit fee) from the department. This includes biomedical
waste generators, storage facilities, treatment facilities, and waste
sharps collection programs.
- Storage of biomedical waste at the generating
facility shall not exceed 30 days. The 30-day period shall commence
when the first non-sharps item of biomedical waste is placed into
a red bag or sharps container, or when a sharps container containing
only sharps is sealed.
- Storage of biomedical waste in a place other
than at the generating facility shall not exceed 30 days. The 30-day
storage period shall begin on the day the waste is collected from
- Indoor storage areas shall have restricted
access and be designated in the written operating plan. They shall
be located away from pedestrian traffic, be vermin and insect free,
and shall be maintained in a sanitary condition. They shall be constructed
of smooth, easily cleanable materials that are impervious to liquids.
- Outdoor storage areas, including containers
and trailers, shall, in addition to the above criteria, be conspicuously
marked with the international biological hazard symbol and be secured
against vandalism and unauthorized entry. The international biological
hazard symbol on an outdoor storage area shall be a minimum of six
inches in diameter.
Packages of biomedical
waste shall remain sealed until treatment, except when compacted in
accordance with biomedical regulations. Ruptured or leaking packages
of biomedical waste shall be placed into larger packaging without disturbing
the original seal.
All packages containing
biomedical waste shall be visibly identifiable with the international
biological hazard symbol and one of the following phrases: “BIOMEDICAL
WASTE”, “BIOHAZARDOUS WASTE”, “BIOHAZARD”, “INFECTIOUS WASTE”, or “INFECTIOUS
SUBSTANCE”. The symbol shall be red, orange, or black and the background
color shall contrast with that of the symbol or comply with the federal
except sharps, shall be packaged and sealed at the point of origin
in impermeable, red plastic bags or, at the discretion of the generator,
into sharps containers. The international biological hazard symbol
shall be at least six inches in diameter on bags 19´´ × 14´´ or larger,
and at least one inch in diameter on bags smaller than 19´´ × 14´´.
Each plastic bag shall meet the following physical properties:
- Impact resistance of 165 grams and tearing
resistance of 480 grams in both the parallel and perpendicular planes
with respect to the length of the bag. Impact resistance shall be
determined using ASTM D-1709-91, and tearing resistance shall be
determined using ASTM D-1922-89.
- Incidental sum concentrations of lead, mercury,
hexavalent chromium and cadmium shall be no greater than 100 ppm
for dyes used in the coloration of bags.
Sharps shall be discarded at the point of origin
into single use or reusable sharps containers. Needles and scalpel
blades shall not be placed directly into double-walled corrugated containers.
Sharps containers must be sealed when full. A sharps container is considered
full when materials placed into it reach the designated fill line,
or, if a fill line is not indicated, when additional materials
cannot be placed
into the container without cramming or when no additional materials
are to be placed in the container. Other requirements for sharps include:
- Permanently mounted sharps container holders
shall bear the phrase and the international biological hazard symbol
if this information on the sharps container is concealed by the sharps
- Reusable sharps containers shall only be emptied
into a treatment cart or directly into a treatment unit. They shall
be constructed of smooth, easily cleanable materials, and shall be
decontaminated after each use;
- The international biological hazard symbol
shall be at least one inch in diameter on sharps containers;
- All outer containers shall be rigid, leak-resistant
and puncture-resistant. Reusable outer containers shall be constructed
of smooth, easily cleanable materials and shall be decontaminated
after each use; and
- The international biological hazard symbol
shall be at least six inches in diameter on outer containers 19´´ x
14´´ or larger, and at least one inch in diameter on outer containers
less than 19´´ x 14´´.
Labeling and Marking Requirements
Generator Labeling Requirements.
Biomedical waste bags and sharps containers shall be labeled with the
generator's name and address unless treatment occurs at the generating
facility. If a bag or sharps container is placed into a larger bag
prior to transport, the label for the exterior bag shall comply with
biomedical labeling regulations. Inner bags and inner sharps containers
are exempt from the labeling requirements
Requirements. Outer containers shall be labeled with the transporter's
name, address, registration number, and 24-hour telephone number prior
to transport. The transporter may provide labels for bags or sharps
containers that are generator-specific, such as bar codes or specific
Treatment and/or Destruction of Biomedical Waste
- Biomedical waste shall be treated by steam,
incineration, or an alternative process approved by the department,
prior to disposal. Treatment shall occur within 30 days of collection
from the generator.
- Steam treatment units shall subject loads
of biomedical waste to sufficient temperature, pressure, and time
to demonstrate a minimum Log 4 kill of Bacillus stearothermophilus spores
placed at the center of the waste load. Additional operating requirements
- Incineration of biomedical waste shall be
achieved in a biological waste incinerator permitted by the DEP.
- An alternative treatment process, such as
chemical, gas, dry heat, or microwave shredding, shall be considered
by the department upon receipt of a written request.
- Biomedical waste may be disposed into a sanitary
sewer system, an onsite sewage treatment and disposal system, or
other system approved to receive such waste by the DEP or the department,
if it is in a liquid or semi-solid form and aerosol formation is
- Body tissues that have been histologically
fixed are considered treated biomedical waste. Tissues prepared by
frozen sectioning only are not considered treated.
- Acute care hospitals, which utilize a certified
onsite treatment process involving grinding and treatment, may dispose
of such treated biomedical waste in the normal municipal solid waste
stream upon notifying the local government responsible for solid
waste collection, under certain conditions.
No registered transporter may knowingly accept
biomedical waste for transport unless it has been properly segregated,
packaged, and labeled.
Each registered transporter shall provide the
generator with a receipt of pick-up
During transport, no registered transporter shall
compact biomedical waste
Transfer of biomedical waste from one transport
vehicle to another is not allowed unless the transfer occurs at a permitted
storage or treatment facility, except as provided in the regulations.
Intermodal transfers of biomedical waste are allowed provided transport
shipping seals remain intact.
Any registered transporter who unknowingly fails
to comply with this section because such biomedical waste has not been
properly segregated or separated from other solid wastes by the generating
facility is not guilty of a violation under this rule.
No registered transporter shall knowingly deliver
biomedical waste for storage or treatment to a facility that does not
have a valid permit issued by the department.
All transport vehicles containing biomedical
waste shall be visibly identified with the business name, registration
number, a 24-hour telephone number, and placards showing the phrase
and the international biological hazard symbol. The symbol shall be
at least six inches in diameter.
All transport vehicles containing biomedical
waste shall be fully enclosed and secured when unattended.
Registered transporters shall notify the department
within one working day by telephone and shall submit a follow-up report
to the department within 10 days, in writing, if there is an accident
that results in a spill of biomedical waste.
In case of an emergency situation, including
mechanical failure, the following is allowed:
- If the emergency occurs during transport,
biomedical waste may be transferred to another transport vehicle,
including a rental vehicle, without being at a storage or treatment
- If a rental vehicle is used, the department
shall be notified of its use on the first working day after the emergency.
A copy of the written authorization from the rental agency stating
awareness of the intended use of the vehicle shall be submitted to
the department within seven days.
- Biomedical waste shall be removed and transported
to a permitted storage or treatment facility within 24 hours of the
- Before return to the rental agency, the vehicle
shall be decontaminated.
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. Florida
is one of 26 states covered entirely by the federal OSHA 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.
Regulations and Guidelines
Biomedical Waste Regulations (Chapter 64E-16, Florida Administrative
Department of Health - Biomedical Waste Website
Florida Department of Environmental
Biomedical Waste Coordinators
For general questions concerning biomedical waste,
contact Edith Coulter or Ed
Golding, of the Florida Bureau of Community Environmental Health,
or by telephone at 850-245-4277.
Biomedical Waste Transporters
Biomedical Waste Treatment Facilities
Biomedical Waste Operating Plan
Application for Biomedical Waste Generator Permit/Exemption
Application for Biomedical Waste Transporter Registration
Application for Biomedical Waste Storage Permit
Application for Biomedical Waste Sharps Collection Program Permit
Biomedical Waste Transporter Annual Report
Biomedical Waste Treatment Facility Annual Report
Application for Biomedical Waste Treatment Permit
Biomedical Waste Training Video
Medical Waste Information at WasteMed.com