State of Florida

STATE OF FLORIDA

DEPARTMENT OF HEALTH

Bureau of Community Environmental Health

Chapter 64E-16, Florida Administrative Code

Biomedical Waste

General. 64E-16.001

Definitions. 64E-16.002

Facility Policies and Procedures. 64E-16.003

Storage and Containment . 64E-16.004

Labeling. 64E-16.005

Generator Requirements. 64E-16.006

Treatment. 64E-16.007

Transport. 64E-16.008

Registration of Transporters. 64E-16.009

Inspections. 64E-16.010

Permits. 64E-16.011

Fees. 64E-16.012

Enforcement and Penalties. 64E-16.013

64E-16.001 General.

(1) This rule prescribes minimum

sanitary practices relating to the management of

biomedical waste, including segregation, handling,

labeling, storage, transport, and treatment. This rule

applies to all facilities that generate, transport, store,

or treat biomedical waste to ensure that the waste is

properly handled to protect public health. Further,

this rule prescribes minimum standards for permitting

biomedical waste generators, storage facilities and

treatment facilities, and for registering biomedical

waste transporters.

(2) This chapter does not apply to

biomedical waste incinerators. This chapter does not

apply to linen that is to be laundered and re-used.

Further, this chapter does not apply to dead bodies

that are disposed of by a person licensed under the

provisions of Chapter 470, F.S., or to the transport of

bodies, parts of bodies, or tissue specimens in

furtherance of lawful examination, investigation, or

autopsy conducted pursuant to Section 406.11, F.S.

Specimens or samples collected for laboratory

testing or use in medical research or teaching are not

considered biomedical waste until such time as the

material is discarded.

(3) The Department. of Health shall

regulate the packaging, transport, storage, and

treatment of biomedical waste. The Department of

Environmental Protection shall regulate biomedical

waste incineration and biomedical waste disposal.

(4) Health care providers shall inform

their home user clients verbally and in writing of the

recommended method for handling biomedical waste

generated in the home setting. Health care providers

who deliver in-home medical services shall remove

or have removed by a registered biomedical waste

transporter all biomedical waste generated during

the performance of these services.

(5) Home users should segregate and

package their biomedical waste in a manner that

reduces the chance of exposure to the public.

(6) Inspections, permitting and

enforcement of emergency medical services that

generate biomedical waste shall be performed by the

Bureau of Emergency Medical Services.

Specific Authority 381.006, 381.0098 FS. Law

Implemented 381.006, 381.0098, 395.002(13),

395.1011 FS. History-New 6-19-89, Amended 12-

14-92, 1-23-94, 6-3-97, Formerly 10D-104.001.

64E-16.002 Definitions.

For the purpose of this chapter, the following

words and phrases shall have the meanings

indicated:

(1) American Society for Testing

Materials, also referred to as ASTM - A technical

society with headquarters located at 100 Barr Harbor

Drive, West Conshohocken, Pennsylvania, 19428-

2959, which publishes national standards for the

testing and quality assurance of materials.

(2) Biomedical waste - 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:

(a) 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.

(b) 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 approved

method.

(3) Biomedical waste generator - A

facility or person that produces biomedical waste.

The term includes hospitals, skilled nursing or

convalescent hospitals, intermediate care facilities,

clinics, dialysis clinics, dental offices, health

maintenance organizations, surgical clinics, medical

buildings, physicians’ offices, laboratories, veterinary

clinics and funeral homes.

(a) Mobile health care units, such as

bloodmobiles, that are part of a stationary biomedical

waste generator, are not considered individual

biomedical waste generators.

(b) Funeral homes that do not practice

embalming are not considered biomedical waste

generators.

(4) Body fluids - Those fluids which have

the potential to harbor pathogens, such as human

immunodeficiency virus and hepatitis B virus and

include blood, blood products, lymph, semen, vaginal

secretions, cerebrospinal, synovial, pleural,

peritoneal, pericardial and amniotic fluids. In

instances where identification of the fluid cannot be

made, it shall be considered to be a regulated body

fluid. Body excretions such as feces and secretions

such as nasal discharges, saliva, sputum, sweat,

tears, urine, and vomitus shall not be considered

biomedical waste unless visibly contaminated with

blood.

(5) Contaminated - Soiled by any

biomedical waste.

(6) Decontamination - The process of

removing pathogenic microorganisms from objects or

surfaces, thereby rendering them safe for handling.

(7) Department - The Department of

Health or its representative county health

department.

(8) Disinfection - A process which

results in a minimum Log 6 kill against the vegetative

organisms listed in Table 1, and a minimum Log 4 kill

against Bacillus Stearothermophilus spores utilizing

steam or a minimum Log 4 kill against Bacillus

Subtilis spores utilizing dry heat, chemicals, or

microwave shredding.

(9) Facility - All contiguous land,

structures, and other appurtenances which are

owned, operated, and licensed as a single entity

which may consist of several generating, treatment,

or storage units.

(10) Hazardous waste - Those materials

defined in Chapter 62-730, F.A.C.

(11) Health Care Provider - Any person

who provides medical care or personal services,as

that term is defined in section 400.402, F.S., to

another individual.

(12) Home User - An individual who

generates biomedical waste as a result of self-care or

care by a family member or other non health care

provider.

(13) Leak resistant - Prevents liquid from

escaping to the environment in the upright position.

(14) Outer container - Any rigid type

container used to enclose packages of biomedical

waste.

(15) Packages - Any material that

completely envelops biomedical waste. This includes

red bags, sharps containers and outer containers.

(16) Person - Any individual, partnership,

corporation, association, or public body engaged in

the generation, storage, transport, or treatment of

biomedical waste.

(17) Point of origin - The room or area

where the biomedical waste is generated.

(18) Public sharps collection program - A

cooperative program designed as a non-profit

community service to assist the home user in the

safe disposal of discarded sharps.

(19) Puncture resistant - Able to

withstand punctures from contained sharps during

normal usage and handling.

(20) Restricted - The use of any measure,

such as a lock, sign, or location, to prevent

unauthorized entry.

(21) Saturated - Soaked to capacity.

(22) Sealed - Free from openings that

allow the passage of liquids.

(23) Sharps - Objects capable of

puncturing, lacerating, or otherwise penetrating the

skin.

(24) Sharps container - A rigid, leak and

puncture resistant container, designed primarily for

the containment of sharps, clearly labeled with the

phrase and international biological hazard symbol as

described in section 64E-16.004(2)(a), F.A.C., and

manufactured with dyes meeting the requirements for

incidental metals as described in section 64E-

16.004(2)(b)1.b.,F.A.C.

(25) Sterilization - A process which

results in a minimum Log 6 kill against Bacillus

Stearothermophilus spores utilizing steam or a

minimum Log 6 kill against Bacillus Subtilis spores

utilizing dry heat, chemicals, or microwave shredding.

(26) Storage -The holding of packaged

biomedical waste for a period longer than three days

at a facility or in a transport vehicle.

(27) Transfer - The movement of

biomedical waste within a facility.

(28) Transport - The movement of

biomedical waste away from a facility.

(29) Transport vehicle - A motor vehicle,

as defined in Section 320.01 F.S., a rail car,

watercraft or aircraft, used for the transportation of

biomedical waste.

(30) Treatment - Any process, including

steam, chemicals, microwave shredding, or

incineration, which changes the character or

composition of biomedical waste to render it

noninfectious by disinfection or sterilization.

Specific Authority 381.006, 381.0098 FS. Law

Implemented 381.006, 381.0098, 395.002(13),

395.1011 FS. History-New 6-19-89, Amended 4-2-

90, 12-14-92, 1-23-94, 8-20-95, 6-3-97, Formerly

10D-104.002.

64E-16.003 Facility Policies and Procedures.

(1) All biomedical waste facilities shall

comply with the following:

(a) Biomedical waste mixed with

hazardous waste, as defined in Chapter 62-730,

F.A.C., Hazardous Waste, shall be managed as

hazardous waste.

(b) Biomedical waste mixed with

radioactive waste shall be managed in a manner that

does not violate the provisions of Chapter 10D-91,

F.A.C. The biomedical waste shall be managed in

accordance with the provisions of Chapter 64E-16,

F.A.C., after the radioactive component has decayed

in storage as provided for in Chapter 10D-91, F.A.C.,

or is otherwise not regulated under Chapter 10D-91,

F.A.C. The packaging requirements of Chapter 10D-

91, F.A.C., shall be followed, unless the requirements

of Chapter 64E-16, F.A.C., are more restrictive.

is neither hazardous nor radioactive in character,

combined with untreated biomedical waste, shall be

managed as untreated biomedical waste.

(d) All surfaces contaminated with

spilled or leaked biomedical waste shall be

decontaminated as part of the cleaning process.

(2) Each biomedical waste facility shall

implement a written operating plan to manage

biomedical waste, in accordance with this chapter.

This plan shall be available for review by the

department and facility personnel. The plan shall

include the following: a description of training for

personnel; procedures for segregating, labeling,

packaging, transporting, storing, and treating,

biomedical waste; procedures for decontaminating

biomedical waste spills; and a contingency plan for

emergencies. Facilities which have multiple specialty

services shall include procedures specific to each

specialty if procedures vary. Plans shall be updated

when regulations, facility policies, or procedures

change.

(a) Each facility or their designee shall

train new personnel who handle biomedical waste as

part of their work responsibilities. This training shall

be provided prior to commencement of duties related

to biomedical waste handling. Refresher training

shall be completed annually by all personnel who

handle biomedical waste. Training shall detail

compliance with the facility’s operating plan and

Chapter 64E-16, F.A.C., and shall be maintained as

a part of the operating plan.

(b) All biomedical waste management

records shall be maintained for 3 years and shall be

available for review by the department.

Specific Authority 381.006, 381.0098 FS. Law

Implemented 381.006, 381.0098, 395.002(13),

395.1011 FS. History-New 6-19-89 Amended 4-2-90,

12-14-92, 1-23-94, 8-20-95, 6-3-97, Formerly 10D-

104.003.

64E-16.004 Storage and Containment.

(1) Storage.

(a) 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.

(b) 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 the

generator.

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.

(d) Outdoor storage areas, including

containers and trailers, shall, in addition to the above

criteria, be conspicuously marked with the

international biological hazard symbol as described in

paragraph 64E-16.004(2)(b), F.A.C., and shall 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.

(2) Containment.

(a) Packages of biomedical waste shall

remain sealed until treatment, except when

compacted in accordance with the requirements of

this chapter as stated in section 64E-16.006(2).

Ruptured or leaking packages of biomedical waste

shall be placed into larger packaging without

disturbing the original seal.

(b) 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 requirements

cited in subpart Z of 29 CFR subparagraph

1910.1030(g)(1)(C), Occupational Exposure to

Bloodborne Pathogen Standard.

1. Biomedical waste, 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” x 14” or

larger, and at least one inch in diameter on bags

smaller than 19” x 14”. Each plastic bag shall meet

the following physical properties:

a. 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.

b. 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.

(d) Sharps containers.

1. 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.

2. Permanently mounted sharps

container holders shall bear the phrase and the

international biological hazard symbol described in

paragraph 64E-16.004(2)(a), F.A.C., if this

information on the sharps container is concealed by

the sharps container holder.

3. 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.

4. The international biological hazard

symbol shall be at least one inch in diameter on

sharps containers.

(e) Outer 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.

(f) 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”.

Specific Authority 381.006, 381.0098 FS. Law

Implemented 381.006, 381.0098, 395.002(13),

395.1011, FS. History-New 6-19-89, Amended 4-2-

90, 12-14-92, 1-23-94, 8-20-95, 6-3-97, Formerly

10D-104.004.

64E-16.005 Labeling.

(1) Biomedical waste bags and sharps

containers shall be labeled with the generator’s name

and address unless treatment occurs at the

generating facility.

(a) If a bag or sharps container is placed

into a larger bag prior to transport, the label for the

exterior bag shall comply with paragraph 64E-

16.005(1), F.A.C. Inner bags and inner sharps

containers are exempt from the labeling requirements

of paragraph 64E-16.005(1), F.A.C.

(b) Outer containers shall be labeled

with the transporter’s name, address, registration

number, and 24-hour telephone number prior to

transport.

(2) The transporter may provide labels

for bags or sharps containers that are generator-

specific, such as bar codes or specific container

numbers. Use of these generator-specific labels

satisfies the requirements of paragraph 64E-

16.005(1)(a), F.A.C.

Specific Authority 381.006, 381.0098 FS. Law

Implemented 381.006, 381.0098, 395.002(13),

395.1011 FS. History-New 6-19-89, Amended 4-2-

90, 12-14-92, 1-23-94, 8-20-95, 6-3-97, Formerly

10D-104.005.

64E-16.006 Generator Requirements

(1) A biomedical waste generator shall

not negotiate for the transport of biomedical waste

with a person who is not registered with the

department as a biomedical waste transporter.

(2) Compacting packages of biomedical

waste within the generating facility, except

recognizable human tissue, bulk liquids, or sharps, is

acceptable provided the following conditions are met:

(a) Packages of biomedical waste shall

not be compacted to a density greater than 22

pounds per cubic foot.

(b) Compacted packages of biomedical

waste shall not be subjected to further compacting.

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

Department of Environmental Protection or the

department.

(d) 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;

(e) Compacted packages of biomedical

waste shall be treated by incineration or other

approved treatment process. Treatment processes,

such as steam, chemical, gas, dry heat, or

microwaving, shall be considered by the department

upon written request and microbiological evidence

that the proposed process provides the same degree

of treatment for compacted waste as for

uncompacted waste. Steam treatment systems shall

be tested against Bacillus stearothermophilus spores,

as described in paragraph 64E-16.007(2), F.A.C.

Other proposed treatment processes shall

demonstrate efficacy using section 64E-16.008 (4),

F.A.C.

Specific Authority 381.006, 381.0098 FS. Law

Implemented 381.006, 381.0098, 395.002(13),

395.1011 FS. History-New 6-19-89, Amended 4-2-

90, 12-14-92, 1-23-94, 8-20-95, 6-3-97, Formerly

10D-104.006.

64E-16.007 Treatment.

(1) Biomedical waste shall be treated by

steam, incineration, or an alternative process

approved by the department as described in section

64E-16.007(4), F.A.C., prior to disposal. Treatment

shall occur within 30 days of collection from the

generator.

(2) 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, and shall be operated in

accordance with the following:

(a) Before placing a steam treatment

unit into service, operating parameters such as

temperature, pressure, and treatment time shall be

determined according to the following:

1. Test loads of biomedical waste which

consist of the maximum weight and density of

biomedical waste to be treated shall be prepared.

Separate loads of red bags, sharps containers,

boxes, and compacted waste shall be prepared if

they are to be treated separately.

2. Prior to treatment, Bacilius

stearothermophilus spores shall be placed at the

bottom and top of each treatment container, at the

front of each treatment container at a depth of

approximately one-half of the distance between the

top and bottom of the load, in the approximate center

of each treatment container, and in the rear of each

treatment container at a depth of approximately one-

half of the distance between the top and bottom of

the load.

3. If the operating parameters used

during the treatment of the test loads demonstrate a

minimum Log 4 kill of Bacillus stearothermophilus

spores at all locations, the steam treatment unit shall

operate under those parameters when placed into

service. If the operating parameters fail to provide a

minimum Log 4 kill of Bacillus stearothermophilus

spores at all locations, treatment time, temperature,

or pressure shall be increased and the tests must be

repeated until a minimum Log 4 kill of Bacillus

stearothermophilus spores is demonstrated at all

locations. The steam treatment unit shall be

operated under those parameters when placed into

service. Tests shall be repeated and new

parameters established if the type of biomedical

waste to be treated is changed.

(b) When operating parameters have

been established and documented using the criteria

in paragraph 64E-16.007(2)(a), F.A.C., the steam

treatment unit may be placed into service.

serviced for preventive maintenance in accordance

with the manufacturer's specifications. Records of

maintenance shall be onsite and available for review.

(d) Unless a steam treatment unit is

equipped to continuously monitor and record

temperature and pressure during the entire length of

each treatment cycle, each package of biomedical

waste to be treated will have a temperature tape or

equivalent test material such as a chemical indicator

placed on a non-heat conducting probe at the center

of each treatment container in the load that will

indicate if the treatment temperature and pressure

have been reached. Waste shall not be considered

treated if the tape or equivalent indicator fails to show

that a temperature of at least 250 degrees F (121

degrees C) was reached during the process.

(e) Each steam treatment unit shall be

evaluated for effectiveness with spores of Bacillus

stearothermophilus at least once each 7 days for

permitted treatment facilities, or once each 40 hours

of operation for generators who treat their own

biomedical waste. The spores shall be placed at the

center of the waste load. Evaluation results shall be

maintained onsite and available for review.

(f) A written log shall be maintained for

each steam treatment unit. The following shall be

recorded for each usage:

1. The date, time, and operator name;

2. The type and approximate amount of

waste treated;

3. The post-treatment confirmation

results by either

a. recording the temperature, pressure,

and length of time the waste was treated, or

b. the temperature and pressure

monitoring indicator;

(g) A current written operating procedure

shall specify, at a minimum, the following:

1. Parameters, determined from testing,

that provide consistent treatment, such as exposure

time, temperature, and pressure.

2. Identification of standard treatment

containers and placement of the load in the steam

treatment unit.

(3) Incineration of biomedical waste

shall be achieved in a biological waste incinerator

permitted by the Department of Environmental

Protection.

(4) 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. The written request

shall be directed to the State Health Officer and shall

include:

(a) The specific treatment process and

type of facility for which acceptance is sought;

(b) The reason for the request;

organisms listed in Table 1, that the proposed

process provides sterilization or a satisfactory level of

disinfection. Using the protocol described in section

64E-16.007(4), F.A.C., alternative treatment systems

must show either:

1. For disinfection, a minimum Log 6 kill

for the vegetative organisms listed in Table 1 and a

minimum Log 4 kill against Bacillus

Stearothermophilus spores utilizing steam or a

minimum Log 4 kill against Bacillus Subtilis spores

utilizing dry heat, chemicals, or microwave shredding,

2. For sterilization, a minimum Log 6 kill

against Bacillus Stearothermophilus spores utilizing

steam or a minumum Log 6 kill against Bacillus

Subtilis spores utilizing dry heat, chemicals, or

microwave shredding.

Table 1

1. Bacteria

a. Bacillus spores -

mandatory, species

determined by treatment

process

Any two

b. Enterococcus faecalis

c. Pseudomonas aeruginosa

d. Staphylococcus aureus

e. Nocardia species

2. Mycobacteria species - any one

a. Mycobacterium bovis

b. Mycobacterium fortuitum

3. Fungus - any one

a. Candida albicans

b. Aspergillus fumigatus

4. Protozoa - Giardia intestinalis or

similar

5. Virus - Poliovirus or similar

(d) Each step of the efficacy testing

must be thoroughly described in the application for

approval. A detailed description of the treatment

process, preparation of organisms, preparation of

test loads, recovery of organisms, and raw data must

be provided.

(e) To begin the efficacy testing, two

challenge loads must be sterilized. These loads

must be composed of materials commonly found in

biomedical waste (tissues, sharps, plastics, glass,

woven materials, blood and blood products, etc.),

and must be of adequate quantity to equal the

maximum capacity of the treatment system. The test

load must be fully described (weight, moisture

content, composition, etc.).

(f) The purity of all organisms and

spores must be certified by a clinical or commercial

laboratory. Each organism must be processed

separately and placed in the test load in the most

difficult location to treat. Before each test run, the

total number of viable test organisms must be

determined and documented. Treatment of the test

load must take place within thirty minutes of

inoculating the load with the test organism.

(g) The test load containing the test

organism must be processed without the agent (e.g.

chemical, microwaves, etc.) used to kill the test

organisms. If this agent is a liquid, it must be

replaced with an equal amount of sterile saline

solution or tapwater. After the test load has

completed one cycle in the treatment device, a

minimum of three grab samples must be taken from

the test load and the number of test organisms

present determined. If the number of organisms

recovered after the test run is less than Log 6, the

number of organisms originally introduced into the

device must be increased, and the run must be

performed again, until at least Log 6 organisms are

recovered. If the number of organisms recovered

from the test run is Log 6 or greater, there is an

adequate number of organisms being introduced into

the device, and the inoculum size should be equal to

this number.

(h) Using the inoculum size determined

in the above procedure, the second sterilized test

load must be inoculated separately. During these

test runs, the chemical or physical agent used to treat

the waste must be used.

(i) After each test run is completed, the

log kill for that particular organism or spore must be

calculated. The number of organisms that were not

recovered from the initial (non-treating) test run must

be subtracted from the number of organisms that

were introduced into the second (treatment) run. The

number of organisms that survive the treatment

process must be subtracted from the first calculation.

The resulting figure is the log kill provided by the

treatment process.

(J) Approved alternative treatment

processes, except single-use, shall meet the

requirements of subsection 64E-16.007(2)(e).

(5) 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

s by the Department

of Environmental Protection or the department, if it is

in a liquid or semi-solid form and aerosol formation is

minimal.

(6) Body tissues that have been

histologically fixed are considered treated biomedical

waste. Tissues prepared by frozen sectioning only

are not considered treated.

(7) Acute care hospitals, licensed under

Chapter 395, F.S., 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 and disposal under the following

conditions:

(a) For the purposes of this chapter,

certified shall mean that the treatment process is a

steam treatment, or has been approved as an

alternative biomedical waste treatment process under

section 64E-16.007(4), F.A.C.

(b) For the purposes of this chapter,

grinding shall also mean shredding or hammermilling.

treatment, procedures that minimize the chance of

exposure to waste handlers must be developed and

implemented should the grinder fail or become

jammed.

(d) Individuals operating the treatment

unit must be trained in all aspects of its operation,

including contingency procedures.

(e) Acute care hospitals must inform the

department in writing of the installation of the unit at

least 30 days prior to placing the unit into service.

(f) Inspection of the unit, including

treatment and maintenance records, will occur during

the annual inspection for the hospital's biomedical

waste permit.

Specific Authority 381.006, 381.0098 FS. Law

Implemented 381.006, 381.0098, 395.002(13),

395.1011 FS. History-New 6-19-89, Amended 4-2-

90, 12-14-92, 1-23-94, 8-20-95, 6-3-97, Formerly

10D-104.007.

64E-16.008 Biomedical Waste Transport

(1) No registered transporter may

knowingly accept biomedical waste for transport

unless it has been properly segregated, packaged,

and labeled.

(2) Each registered transporter shall

provide the generator with a receipt of pick-up.

(3) During transport, no registered

transporter shall compact biomedical waste or allow it

to leak into the environment.

(4) 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 paragraph

64E-16.008(10)(a), F.A.C. Intermodal transfers of

biomedical waste are allowed provided transport

shipping seals remain intact.

(5) Any registered transporter who

unknowingly fails to comply with subsections (3) or

(4) of 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.

(6) No registered transporter shall

knowingly deliver biomedical waste for storage or

treatment to a facility which does not have a valid

permit issued by the department.

(7) 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 as

described in paragraph 64E-16.004(2)(a). The

symbol shall be at least six inches in diameter.

(8) All transport vehicles containing

biomedical waste shall be fully enclosed and secured

when unattended.

(9) 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.

(10) In case of an emergency situation,

including mechanical failure, the following is allowed:

(a) 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 facility.

(b) 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.

and transported to a permitted storage or treatment

facility within 24 hours of the emergency.

(d) Before return to the rental agency,

the vehicle shall be decontaminated.

Specific Authority: 381.0098 F.S. Law Implemented

381.0098 FS. History-New, 6-3-97, Formerly 10D-

104.0073.

64E-16.009 Registration of Biomedical Waste

Transporters.

(1) Biomedical waste transporters shall

be registered with the department. Biomedical waste

generators transporting less than 25 pounds of their

own biomedical waste, in their own transport vehicle,

on any single occasion, are exempt from transporter

registration, fee, and placarding requirements of this

chapter.

(2) Each owner or operator of a

transport vehicle shall submit to the department a

completed application for registration on form DH

4106, herein incorporated by reference.

(3) Biomedical waste transporter

registrations shall expire on September 30 each year.

Renewal applications will not be considered complete

without the submission of an annual report on form

DH 4109, herein incorporated by reference.

Biomedical waste transporters with valid

registrations, on the effective date of this chapter,

shall renew their registration by September 30

following the expiration date of their existing

registration.

(4) Registered transporters shall notify

the department in writing within 30 days of any

changes made to their registration form currently on

file with the department.

(5) Any registered biomedical waste

transporter is subject to having their biomedical

waste transporter registration denied, suspended, or

revoked, pursuant to Section 381.0098, F.S., and in

accordance with the procedural requirements of

Section 120.60, F.S., upon a finding by the

department that the transporter:

(a) Has submitted false or inaccurate

information in the application or annual report;

(b) Has violated the provisions of any

statute or rule which the department is authorized to

enforce;

records or equipment by department personnel.

Specific Authority 381.0098 FS. Law Implemented

381.0098 FS. History-New, 6-3-97, Formerly 10D-

104.013.

64E-16.010 Inspections.

(1) Department personnel shall inspect

registered transport vehicles, permitted generators,

storage, and treatment facilities at least once a year.

Those facilities exempted from the registration and

fee requirements under subsection 381.0098(4), shall

be inspected at least once every three years.

Reinspections may be conducted when a facility is

found to be in non-compliance with this chapter.

Results of each inspection shall be recorded on a

form provided by the department.

(2) To provide consistency of

inspections throughout the state, all department

personnel who inspect biomedical waste facilities

shall attend training annually, which shall be

approved by the Bureau of Environmental Health

Programs.

Specific Authority 381.006, 381.0098 FS. Law

Implemented 381.006, 381.0098 FS. History-New 12-

14-92, Amended 1-23-94, 8-20-95, 6-3-97, Formerly

10D-104.0075.

64E-16.011 Permits

(1) All biomedical waste facilities, except

those facilities operating under a Department of

Environmental Protection permit, shall obtain a

permit from the department annually. Application

forms and annual report forms used by the public

may be obtained from the environmental health

section of the county health department in the county

of their location or from the Department of Health,

Bureau of Facility Programs, 4052 Bald Cypress

Way, Bin A08, Tallahassee, Florida 32399-1710. All

forms listed in this section are incorporated by

reference.

(a) A biomedical waste generator, who

produces or treats less than 25 pounds of biomedical

waste in each 30 day period, shall be exempt from all

permit and fee requirements of this chapter.

(b) Application for an initial biomedical

waste generator permit or exemption from permitting

shall be submitted to the department on form DH

4089, Application for Biomedical Waste Generator

Permit/Exemption, 8/98. Biomedical waste treatment

facilities which were constructed prior to December

31, 1995, or for which an operation permit was

submitted to the Department of Environmental

Protection prior to December 31, 1995, shall meet

the requirements of this chapter at the time of

renewal of their existing permit.

waste storage facility permit shall be submitted to the

department on form DH 4107, Application for

Biomedical Waste Storage Permit, 8/98.

(d) Application for an initial biomedical

waste treatment facility permit shall be submitted to

the department on form DH 4111, Application for a

Biomedical Waste Treatment Permit, 8/01.

Renewals will not be considered complete without

the submission of an annual report submitted on form

DH 4110, Biomedical Waste Treatment Facility

Annual Report, 8/01.

(e) Application for an initial biomedical

waste sharps collection program permit shall be

submitted to the department on form DH 4108,

Application for Biomedical Waste Sharps Collection

Program Permit, 8/98.

(f) Permits shall not be transferable

from one person to another. In the event of an

address or name change, an amended application for

permit shall be submitted to the department. A

permitted generator may work at a branch office for

no more than six hours in any seven day period

without applying for an additional permit. These

generators must notify the local county health

department biomedical waste coordinator of the

existence and operating hours of the branch office.

1. In the event of a change of

ownership of the facility or a newly constructed

facility, an application for an initial permit shall be

submitted to the department within 30 days of the

commencement of business.

2. When a facility is leased by the

owner to a second party for operation, the second

party shall apply to the department for an initial

permit within 30 days of the commencement of

business. The second party shall be held

responsible for the operation and maintenance of the

facility.

(g) Permits shall expire on September

30 each year. The permit, or a copy thereof, shall be

maintained within the facility and shall be made

available for review by department personnel.

(2) Persons engaged in a sharps

collection program with single or multiple facility

locations may operate under a single permit

provided:

(a) The sharps collection program is

open to the general public;

(b) A list identifying the location of each

facility is attached to the application; and

permit requirements.

Specific Authority 381.006, 381.0098 FS. Law

Implemented 381.006, 381.0098, FS. History-New

12-14-92, Amended 1-23-94, 6-3-97, Formerly 10D-

104.0076, Amended 11-5-02.

64E-16.012 Fees

(1) State-owned and operated

biomedical waste facilities are exempt from the

permit fee.

(2) Fee schedule.

Generator Permit:

(application received

by October 1) $85.00

(application received

after October 1) $105.00

Treatment Permit:

(application received

by October 1) $85.00

(application received

after October 1) $105.00

Storage Permit:

(application received

by October 1) $85.00

(application received

after October 1) $105.00

Transporter Registration (one vehicle):

(application received

by October 1) $85.00

(application received

after October 1) $105.00

Additional Vehicle $10.00

No fee or combination of fees shall exceed the

maximum amount established by the statute.

(3) All fees collected pursuant to this

section shall be placed in a specially designated

account within the individual county health

department trust fund to be used to meet the cost of

administering the biomedical waste program

described in this chapter.

Specific Authority: 381.006, 381.0098(4) FS. Law

Implemented 381.006, 381.0098 FS. History-New 12-

14-92, Amended 1-23-94, 6-3-97, Formerly 10D-

104.0078, Amended 1-12-09.

64E-16.013 Enforcement and Penalties.

(1) According to section 381.0025, F.S.,

any person who generates, transfers, treats, stores,

transports or disposes of biomedical waste in

violation of this chapter; or who interferes with,

hinders, or opposes any employee of the department

in the discharge of his duties, or who impersonates

an employee of the department, is chargeable with a

misdemeanor of the second degree, punishable as

provided in sections 775.082 and 775.083, F.S.

(2) For violation of any provision of

Chapter 64E-16, F.A.C., the department shall deny,

suspend or revoke any biomedical waste permit or

impose an administrative fine of up to $2500 per day

for each violation of this chapter or pursue other

enforcement action authorized by law. In

determining the type and degree of enforcement

action necessary, the department shall take into

consideration the following:

(a) The gravity of the violation, including

the probability that death or serious physical harm to

any person may result or has resulted, the severity of

the actual or potential harm, and the extent to which

the provisions of the applicable statutes or rules were

violated.

(b) Actions taken by the owner or

operator to correct violations.

Specific Authority 381.0061, 381.0098(5) FS. Law

Implemented 381.0012, 381.0025, 381.006,

381.0061, 381.0098, 395.002(13), 395.1011,

775.082, 775.083 FS. History-New 6-19-89,

Amended 12-14-92, 1-23-94, 6-3-97, Formerly 10D-

104.008, Amended 11-5-02.