CHAPT ER 64E-17 TAN NING F ACI LITIES
64E-17.001 Definitions.
64E-17.002 Design
and
Safety Requ irements.
64E-17.003 Requiremen ts for Stand-up
Booths.
64E-17.004 Operation and Training.
64E-17.005 Sanitary Faciliti es.
64E-17.006 Licenses an d
Fees.
64E-17.007 Inspection, Enforcement
and Penalties.
64E-17.001 Definitions.
(1) “Customer” –
Means any
person who is provided access to
a tanning facility
in exchange for a fee or
ot her
compensation, or an y person who, in
exchange for a fee or other compensation,
i s a fforded use of
a tanning facility
as a condition
or benefit of
membership or access.
(2)
“Employee”– Means someone who is
workin g
in or
for a tanning
esta blishment
whether fixed or mobile,
who is
in dir ect with the
customer for the purposes of
cle aning,
saniti zing,
mainte nance
of tanning devices, determining human skin
types a nd maxi mu m allowable
time of
exposure; and assisting
the customer in the prop er use of tan ning
devices.
(3) “Formal training”
– Means
a cour se of instru ction approved by the
department conducted o r presented under
formal classroom conditions b y a person possessing
adequate kn owledge and experience to
offer a
curriculum, associate d tr aining,
and certificat ion testing
perta ining
to and associat ed with the corr ect use of ta nning equipment. Training sha ll
cover ultrav iolet radiation and effects on
the skin,
skin typin g , exposure time, photosensitivity, FDA and State regulations, eye
protection, and equipment and maintenance.
(4)
“Operator” – A tanning facility owner or
a person
who operates
a tan ning facil i ty.
(5) “Overrid e
timer control”
– Means
a separate
e lectrica l timer,
switch, or similar device
which may b e used by the
operator to start, stop, or reset
the
timer system for a tanning
machine. The term does
not include electric service
panels w hich
contro l the
entire electrica l system for
a building
or a portion
of a building.
(6)
“Person” – Means any individual,
corporation, partnership, associat ion, politica l subdivision of this
stat e, any
other state
or political
subdivisio n or
department thereof, and any legal succe ssor ,
representa tive, agent,
or department
of the
for egoing.
(7)
“Phototherapy device” – A piece of
equipment that emits ultraviolet
radiation and that used by
a licensed he alth
care pro fessional
in t he treatment
of disease.
(8)
“Reconditioning” – Means
a process
or proce dure by which distresse d
tanning can be
brought into complia nce with fed eral
and stat e standards for use
by the
public.
(9)
“Safe level”
– Means
not more
than 50
colony -forming
un its
per four
( 4) square
inches of eq uipment
surface.
(10) “Sanitize”
– Means
the effective
bactericida l treatment
of surfaces
of equipment and which
provides a sufficient conc entration of chemicals and
enoug h
time to
reduce the b acterial cou n t, includ ing pathogens, to
a safe
level.
(11)
“Stop-use order” – Means
a notice
written t o a tanning
f acility
by the
department to remove a ta nning
device from servi c e because the device
does not
meet the of this ru le ,
or the
device is not be ing
operated in accordan ce with the requirements of this ru le . This is a pr oposed age ncy action issued
pursua n t
to Section F.S. The notice shall
in clude a
statement of an individual’s right t o request
a hearing on t he proposed action.
Specific Auth ority 38 1.011 (13), 381.8 9(1 3) FS . Law I m plem ented
381.89 (10 ), (12) FS. Hi sto ry– Ne w
1-1 2-93 ,
Am ended 8-7-96 , Fo rm erl y
10 D-1 12.00 3, Am ended 5-10 -0 5 .
64E-17.002 Design and Safety Requirements.
Each
tannin g
facility sha ll be design ed, operated, and maintained to
meet the
followi ng
minimu m requirements:
(1) Prior to
the use
of a structure
as a tanning
fa cility,
plans
of the facil ity and its proposed op eration shall be
submitted to and app roved
by the local
co unty
health department. All plans sh all be legib le , drawn to
scale and
sh all
comply
with
the requirements
of this
chapter .
Plans shall
show the
lo cation
of all tanning
devices and sanitary facilit ies. A pplicant shal l
also su bmit the manufacturer, model number and serial number
for all
tan ning
devices and lamps being used within
the
facility, as w ell as the ta nning equipm ent suppli er. All plans shall be pro c essed i n accordance with
the requirements
of Section
120 .60,
F.S.
(2)
Physical facilit ies.
(a) The warning
sign re quired by Section 381.8 9(4)(b),
F.S., shall be re adily legible, clearly
visible, and not o bstructed by
any ba rrier, equipment, or other ite m present so that the user can
easily view the warning sign
be fore
energizing the ultraviolet light generating e quipment.
(b)
Only tan ning equipment manufactured, certified and
legib ly
labeled to comply with 21 of
Federal Regulations (C.F.R.), Part 1040,
Section 104 0.20, “Sunlamp Products
and Ultraviolet Lamps Intended
For Use
In Sunlam p Products”, April 1,
1 999 , herein by reference, sha ll be us ed in tanning facilities.
Tan ning
devices t hat have been reconditione d must comply with federal
and state
requirements. Compliance shall be ba sed
on the
fe deral
standa rd
in effect
a t the time
of manufacture
as shown
o n device
identificat ion label.
Each
tan ning
device
shall have a timer,
which complies with
the requirements
of 21 Part 1040,
Sectio n
1040.20(c)(2)(3). The maxi mum ti mer interval shall not
exceed the manufacturer’s maximu m recomme nded
exposure time. No timer interval have
a n error
greater than plus or
minus 10%
of the
maximu m
timer interval
for the
product. Th e tanning de vice
timer shall
be set
b y a trained operator
or other
trained employee. All tanning
equipment shall be provided
with an
override timer control installed o u t s ide of the r oom in which
a tanning device
is located
and op erated only by tanning facility personnel. tannin g device must be equipp ed with an emergency s hut-off mechanism on
the device allowing manual termination
of th e
UV expos ure by the consumer, as
required by 21 C.F.R.
1040.
(d) There
sh all
be physical
barriers to protect cust omers from i njury through
contact wit h hot or broke n
lamps.
(e)
There sh all be physical barriers a round each t anning device
which is in
use, such as
permanent or portable partitions, to protect
peo ple
who are
not using
th e
device from accidental ultraviolet radiation exposures.
(f)
A trained
operator or other traine d
facility employee shall clean
and pr operly saniti ze any reusable protective
eyewear an d body contact
surface s
of tanning
d evices after use.
(g) When sa nitizing t anning equipment and
prote c tive eyewe ar, the facilit y shall use a sanitizer
ca pable
of prov iding a saf e level of microorganisms,
as require d by this rule. A clean
paper
or cloth tow el shall be u s ed each time
the bed
or other
equipment is Th e
sanitizer, as describe d
in this cha pter, is one specifically manufactured
for sanitizing ult raviolet light emitting equipment, protective
eyewear, is regist ered with the U.S. Enviro nmental Protection Agency (EPA), a nd does not damage
the acrylic
plasti c
surface of th e
unit.
(h)
A test
kit
or other device that accurately
meas ures
the co ncentration of the sanitizing
solution in p arts per
milli on
shall be used
to measure
the stre ngth of the sanitizing at least twice p er day of
tanning facility operation to ensure sufficient
strengt h
of the sanitizin g solution.
(i)
Each cust omer shall be provided with
protective eye wear that meets
the requirement 21 C.F.R. Part
1040, subsection 1040.20(c)( 4), April 1, 1 999 and inst ructions
for t heir use. The
op erator
or employee
shall
not allow an y person to use
a tannin g
device if t hat
person refuses to use
pr otective
eyewear.
(j) There sh all
be suff ici ent
protective eyewear o n the
premises of a tanni ng
facility to equal the maximu m
nu mber
of persons
that ar e able to use the
tannin g
devices at the same time.
(k) Exposure
to the
ultrav iolet
radiation produced by the
tanning equipment itself is
no t
considered a sanitizing
agent for protective eyewear or
tanning devices.
In
additio n
to the
req uirements
in subsect ion 381.89(6)(c), F.S., each person usin g a device
shall
be instructed by the operato r or a traine d
employee on the maxi mum
e x posure time,
as recommended
by t he manufacturer
of device.
The operator
or a
traine d
employee shall in struct the
customer as to the location and proper operation of
the t anning device’s
emergency shut-off mechanism.
(m)
The operator
must ensure
that n o individual is
allowed to use a
tannin g
device more than once ev ery 24
hours.
Specific
Auth ority 38 1.89 (1 3) FS. Law I m pl em ented
381.89 (4 )(a ) FS. History– Ne w 1-1 2-93 , Am ended
8-7 -96 , Fo rm erly 10D-112.0 04 , Am ended
5-10-0 5 .
64E-17.003 Requireme nts for Stand-up Booths.
(1)
There sh all be floor markings
or other
means to
indicate t he proper exposure
distance bet ween ultraviolet
lamps a nd the user’s
skin.
(2) The upright booth
sh all
be of
rigi d
constructi on
and so
d esigned as
t o
withstand the stress of us e and the
impact of a falling person. The
doors shall
open ou twardly and be designed for rapid exit
from the
booth in
emergencies.
(3) Non-slip floors shall be
provided to reduce th e
potential f or injuries fr om falls. Flo ors shall be con s tructed
of e asily cleana ble
surface s
and of
such
material, fin ish
and so
fabricated th at residue may be
effectively re move d by normal cleaning methods.
The temperature in enclo sed booths shall
be maintained
below 100ºF
(38ºC).
Specific Auth ority 38 1.89 (1 3)
FS. Law I m pl em ented 381.89 (6 )(c) FS. History– Ne w 1-1 2 93, Am ended
8-7 -96 , Fo rm erly 10D-112.0 05 , Am ended
5-10-0 5 .
64E-17.004 Operation a nd Training.
(1) Each tanning facility
shall have
a n operator
who possesses
a certif icate of formal training, as defined in
R ule 64E-17.001,
F.A.C. Formal training courses f or operators
must meet t he
requirements of subsection 64E- 17.001(3),
F.A.C. When formal training courses are not availabl e within a si xty-mile
radius of a tanni ng
facility in the time
frame specified in subsecti on 64E-17.004(4), F.A.C., then the
ope rator
of that facility
may substitute th e succe ssful
completion of a corresp ondence training course. Correspondence course s must meet the subject matter
requirements of subsection 6 4E- F.A.C., and be approved
by the
department in order to qualify
as training
f or
operators.
(2)
In additio n to the req uirements
of subsect ion 64E-17.001(3), F.A.C., each formal
training cour se shall me et
the following
requirements.
(a) Each co urse shall b e at least
4 hours in
len gth
and con c lude
with a n exam o v er the information presented in the course. These
4 hou rs shall no t include item s
such a s registration, breaks,
lunc h,
marketing, profit-making strategie s ,
advertisin g
and accounting, taking a test , or similar f unctions.
(b) Training shall
in clude the
followin g
study topics
for the
minimum hours indicat ed:
1. Ultraviolet radiation
an d
effects on the skin,
2. Skin
typing,
3. Exposure time,
4. Photosen sitivity,
5. Statute 381.89,
FDA-Title 21 C.F. R. Part 1040 ( April 1, 1 999 ) and
Chapter 64E 17, F.A.C.,
6. Eye protec tion,
7. Equipment
and maintenance.
(c)
Each co urse shall cover the
required subjects and inclu de
written material, su ch as a core
training manual; audio-visual pr esentations; slides
or vid eos; copie s of the
department’s statute, rules and
copies of Title 2 1 , Code
of Federal
Regulations, Part Sectio n 1040.20; a nd a questio n
and answer
period for trainees.
(3)
Each employee
who assist s the custom er or operates tan ning devices must be trained on th e proper operation and maintenance of
tanning devices. Th e
operator of the tanning facility is
respon sible
for training
those em ployees and ensuring that
those employees take an appr oved
training course. Pr oof of trainin g
must be
maintained wit hin the facility and
be available
for inspe c tion. When the
operator provides employee training, that training sha ll
include:
(a)
Review
of the requir ements of these rules;
(b)
Procedures for correct cleaning,
sanitizing an d operation of
the device;
(c) Recognit ion of overexposure or similar injury;
(d) Review of manufacturer’s proce dures for op eration and maintenance of
tanning devices;
(e)
Medical aspects of u ltraviolet radiation,
photo s ensitivity, maxi mum al lowable time of exposure, and determination
of human
skin type s as it re late s to complia nce use of t he FDA
exposu re
schedule; and
(f) Emergen cy procedures in ca se
o f overexpos ure
or injury.
(4)
Operators and other f acility
perso nnel,
who must
comply with the trai ning
requirements of this cha pter,
must complete
the required
training according to the following:
(a)
Operators hired on or after the
eff ective
date of
this chapt er must complete the required training prior to taking charg e of a facility. Other facility
personnel hired on or after the
eff ective
date of
this chapt er shall hav e a period of 30
days after
the effective
date of employment to s uccessf ully comple te
the required
tr aining;
how ever,
such persons sha ll work unde r the direct supervision of
a trained
o perator, until
they have
successfully completed the
required training;
(b)
All perso nnel hired b efore the
eff ective
date of
this chapt er shall hav e a period of 30 days
after the
effective date of this chapter to
su ccessfu lly complete the required training.
(5) Any
individual or orga nization req uesting the department to
review their training for compliance with
the requirements
of this
rule,
sh all
submit co pies of their
training materials to the department
prior to
providing that training in the
state. The materials su bmitted should include credentials
of trainers and persons
co mpiling
the training materials, a cop y
of the
classroom, Internet or corre spondence course
curriculum, copies of
written materials to be received
by train ees, a copy of the
test to given and
answers t o the test
qu estions,
and
a statement indicating t he
length of time a classroom
course will be conducte d. The depa rtment shall review
the materials
and inform the applicant of it s
finding s
within 30 days from receipt
of all
train in g materials. When chan ges are made to a trainin g
course tha t has been
r eviewed and
accepted by the
department, those changes shall also
be su bmitted
to the
department for review prior making the
changes p ermanent
in the
training literature.
(6)
In order
to inform
and assist the
customer in the proper use
of tannin g devices a nd suitable phy sical a ids,
such as
hand rails
and flo or
markings, an operator or facility
employee who has been trained
in a ccordance with
the requirements
of this
rule mu st be present when tanning eq uipment is u s ed. Prior to initial
exposure, each cu stomer must given
a copy
of a
written warning and shall be
provided the opportunit y to read the copy of
the warning
specified in par agraph
64E-17.002(2)(a), F.A.C. The
operator or shall then req uest that the customer sign
a statement
that the
information has been read and understo od and agrees to use
pr otective
eyewear. For illi terate or visually handicappe d
persons, t he warning statement
shall be
read
by the operator or employee the
prese nce
of a
wit ness.
Both t he witness
a nd the
operator or employee shall sign statement.
The cust omer must b e informed
whether the facility has li ability insura nce
and the amount of such l iability insur ance
shall b e stated when
requeste d.
(7)
A written
and/or elect ronic record shall be kep t for a perio d
of four
years by
the facility oper ator
of each customer’s signature,
a ge, date
of t anning visits,
total number
of tanning visit s , tanning time exposures,
and the name
of the
operator or employee who assisted
the custom er.
(8)
A written
report of any alleged tanning
injury shall be for warded
to the
local coun ty health depar tment which issued
the
license within five working
days of
its
occurrence or
knowledge t hereof. The
report shall include:
(a) The
date of
alleged injury and name and
contact information of the aff ected individual;
(b) The
name, location
a nd license n umber of
the tanning
fa cility
involved and the na me the opera tor
or employee
who assisted
the cu stomer;
(c)
The natu re of the alle ged
injury and duration of
the tannin g exposure;
(d)
Name an d address
of the health
care provider,
and treatment,
if any; and
(e)
Information on the de vice
involve d ,
such as t he
manufacturer, model number, lamp used, and
a ny other
information considered rele vant to the situation by
the local cou nty health depar tment.
(9) Burned-out
or defect ive lamps or defective filt ers shall b e replaced
wit h
a type intended for use in
that d evice as spe c ified
on the product
lab el
on the
tan ning
equipment or with lamps
or filters
tha t
are equivalent
under 21
C.F.R. 1040.20. When substitute la mps are being used, a
statement from the manuf acturer
stating the replacement lamps are FDA equivale nt
must be
kept within
th e
facility and be availabl e for review. If a tanning d evice has b een recondit ioned,
a stat ement from the
manufacturer or FDA stating
the replacement
lamps are
equivalent must be kept wit hin the facility and be available
for review.
(10)
The owner’s
manual for each ta nning
device shall be o n file
at the
t anning
facilit y.
Specific Auth ority 38 1.89 (6 ),
(13 ) FS. Law Im plem ented 381.8 9(13 ) FS. History– Ne w
1-1 2-93 , Am ended
8-7 -96 , Fo rm erly 10D-112.0 06 , Am ended
5-10-0 5 .
64E-17.005 Sanitary Fa cilities.
(1)
The water
supply for the tanning facility shal l
comply with the provisio ns of Chapter
or 62-550,
F.A.C.
(2)
Sewage disposal sha ll
comply with the provisions of
Chapter 64E-6 or 62-600, F.A.C.
(3)
The sani tary facilities shall be ke pt
clean, maintained and in
complian c e with
Chapter F.A.C., and local building a nd plumbing
codes.
Specific
Auth ority 38 1.89 (1 3) FS. Law I m pl em ented
381.89 (13 ) F S. History– New 1-12 -93 , Am ended
8-7 -96 , Fo rm erly 10D-112.0 07 .
64E-17.006 Licenses and Fees.
(1)
License r equired.
(a) Each
tanning facility shall obtain a license fro m the department annually.
(b)
Licenses for tanning f acilit ies shal l not be
tran sferable
fro m
one locati on or perso n to another.
(c)
All tannin g facility li ce nses sha ll
ex pire on
September 30 of each year.
(d) Licenses shall be
po sted
in a
co nspicuous
lo cation
on th e premises.
(2) License application .
(a) Each person who
pla ns
to constr uct, purchase, reopen, o r operate
a tanning
facilit y
shall apply f or
and receive
a license from
the department
prior to
the co mmence m e n t
of operation.
(b) Applications for init ia l licen ses sh all be acco mpanied
by the annual
o r prorated
fee required in subsection (5 )
and shall contain
at lea s t
the following
information:
1. Name, ad dress and te lephone nu mber of the tanning facility
and the
owners and manager of the tanning
f acility.
2. The number
and type
of tanning
d evices locat ed within th e facility.
3. The geog raphic areas within the st ate to be co vered,
if the facility is mo bile.
4. A
statement that the applicant
ha s
read and
u nderstands t he requirements
of these
rules.
5. A
copy of
the facility’s operating
an d
safety procedures.
6. A certifica te
of insuran c e
or the
na me
and policy
number o f the
insuran c e company
that provides liabi lity
insurance must be provided by
facilities that have liability
insurance, i ncluding the limits of
liab ility.
(c)
Persons with license s for
tanning facilit ies tha t have changed ownership, or
that h ave license s
rein stated
after
revocation, or that
have facility
inform ation
changes, excludi ng name changes, compared
to the
original applica tion, must
comply with pa ragraph (b).
(3)
License, Renewal, and Transfer.
(a)
Before a license is
is sued to
a ne wly constructed or remodeled tannin g facility, an inspection shall be
made by
a representative
of the
department for the d etermination of compliance with the
requirements of this rule.
(b)
An application
for re newal of an existing ta n ning
facility license is not required except as provided in
paragrap h
(2)(c) above.
(4) Reporting Changes.
(a)
The licen see shall re port change s to the dep artment
in writing
before
making any change which would render
the inform ation reported pursua n t to subsection (2) above
and contain ed in the ap plication for license
no lo nger
accurat e .
(b)
This req uirement shall not apply to changes involving
the replacement
of lamps
with designated original equipment replacements
or lamps
which have
been certified
for u s e those
de vices
as equ ivalent lamps as spe c ifie d
by the
product warnin g label and FDA e s applicable
at the time
of replacement
of the
lamps for
tanning devices.
(c)
The facility
owner or manager
shall maintain a
copy on
file of
any ma nufacturer’s literature de monstrating
the equivalency
of any
replacement lamps for tanning devices.
(5)
Fees.
(a) A person
applying for an annual license
sha ll pay
the full
fee. All
other
applicant s, such as for a change
of ownership, reinstatement
after revocation
of lice nse or a ne w
license a fter the first
qua rter
shall pa y a prorated fee on
a qu arterly basis. Annual fee s must
be received
by the department
within 30 d ays of
written notificat io n or a late renewal fee will be asse ssed.
All tan ning facil itie s shall p ay an annual
or prorated fee
to the county health departm ent
according to the following:
1. Annual License
Fee ( one device) $150.00
Each
additional device $55.00
Total fee not
to exceed $315.00
2. Late rene wal
of license $25.00
(b)
All fees
collected pur suant to this
rule shall b e placed
in t he county
health department trust fund
to be used
to meet the
cost of
carryin g
out the
pr ovisions
of t his rule. All
fees submitted
to the
departm ent
are nonrefundable, once
action
has been taken on the applicatio n.
Specific
Auth ority 38 1.89 (1 3) FS. Law I m plem ent ed
381.89 (3 )(a ), (b), (c), (13) FS. History– Ne w 1-12 -9 3 , Am e nded 8 -7 -96 ,
Form erl y 10 D-112.0 08, Amende d 5-1 0-0 5 .
64E-17.007 Inspection, Enforceme nt
and Penalties.
(1) The resu lt of each de partment
inspection sha ll be recorde d on DOH F orm 4097, incorporated herein
by reference,
and
a legible co py
shall be provided
to the
operator. A copy of the latest
inspec tion
report shall remain on the
premises and be available
to any consum er who asks to
s ee it.
(2)
For violations
of this chapter,
the
department shall issue
a stop-use or der to any tanning facility or
pursue other enforcement action authorized by
law.
(3)
A facility’ s licen se sh all
not be
su spended
un der
this se ct ion
for a
peri od
of more
than months. At the
end of
such perio d of suspen sion, the tan ning
facility may appl y for reinstatement
or reissua nce of the license. A
tan ning
facility which has h ad its revo ked
must reapply
to the
department for a new license
for that location.
(4)
Whenever a license is
denied, suspended, o r revoked,
or the
department takes similar actio n that affect s the substa ntial
intere st s of a tannin g
facility, the department
notify applicants of their
right to request
a he aring on the matter.
Notification shall be in writing and
it shall indicate that a
hearing must be reque sted
within 3 0 days of
the applicant’s r eceipt
of the notice.
The
department shall grant
o r deny
the hearing
requ est
within 10 da ys
of receipt of
said requ est. All hearings shall be conducted
in accordance
with the provisions of Chapter 120, F.S.
Specific
Auth ority 38 1.011 (13), 381.8 9(1 3)
FS . Law I m plem ented 381.89 (3 ), (1 0), (12 )
FS. Histo ry–New 1-12 -9 3 , Am e nded 8 -7 -96 ,
Form erl y 10 D-112.0 09