216-RICR-40-10-24
216-RICR-40-10-24. Tanning Facilities (version Amendment, 08/27/2018 to 01/04/2022)
24.1 Authority
These regulations are
promulgated pursuant to the authority conferred by R.I. Gen. Laws §
23-68-8, and are established for the purpose of regulating tanning
facilities to minimize the risks associated with tanning by
artificial ultraviolet light.
24.2 Purpose
A. The purpose of this Part is
to regulate tanning facilities to minimize the risks associated with
tanning by artificial ultraviolet light. These risks include, but
may not be limited to:
1. Sunburn;
2. Premature aging of the
skin;
3. Skin cancer;
4. Retinal damage;
5. Formation of cataracts;
6. Suppression of the immune
system;
7. Damage to the vascular
system; and
8. Communication of disease
due to improper sanitation of tanning devices.
24.3 Incorporated Materials
A. These regulations hereby
adopt and incorporate 21
C.F.R. § 878.4635(b)(6)(i)(A) (2017) by reference, not including
any further editions or amendments thereof and only to the extent
that the provisions therein are not inconsistent with these
regulations.
B. These regulations hereby
adopt and incorporate 21
C.F.R. § 1010.3 (2017) by reference, not including any further
editions or amendments thereof and only to the extent that the
provisions therein are not inconsistent with these regulations.
C. Except as provided in this
Part, the requirements of
21 C.F.R. § 1040.20 (2017) are incorporated by reference, not
including any further editions or amendments thereof and only to the
extent that the provisions therein are not inconsistent with this
Part.
24.4 Definitions
A. Wherever used in this Part
the following terms shall be construed as follows:
1. "Act" means R.I.
Gen. Laws Chapter 23-68 entitled, "Tanning Facility Safety
Standard Act."
2. "Department"
means the Rhode Island Department of Health.
3. "Director" means
the Director of the Rhode Island Department of Health.
4. "EPA" means the
United States Environmental Protection Agency.
5. "FDA" means the
United States Food and Drug Administration.
6. "Minor" means any
individual under the age of eighteen.
7. "Other compensation"
means the payment or exchange of goods, services or anything of value
for use of the tanning device or devices.
8. "Patron" means
any member of the public who is provided access to a tanning device
in exchange for a fee or other compensation, or any individual who,
in exchange for a fee or other compensation, is afforded use of a
tanning device as a condition or benefit of membership or access.
9. "Person" means
any individual, corporation, partnership, firm, association, trust,
estate, public or private institution, group, agency, political
subdivision of this state, any other state or political subdivision
or agency thereof, and any legal successor, representative, agent or
agency of these entities.
10. "Protective eyewear"
means any device designed to be worn by users of a product to reduce
exposure of the eyes to radiation emitted by the product.
11. "Registrant"
means any person who is registered with the Department as required by
provisions of this Part.
12. "Registration"
means registration with the Department in accordance with provisions
of this Part.
13. "Safe level"
means not more than fifty (50) colonies of microorganisms per four
(4) square inches of equipment surface.
14. "Sanitization"
means the effective bactericidal treatment of surfaces of equipment
and devices by an EPA or FDA registered product which provides a
sufficient concentration of chemicals, allowing enough time to reduce
the bacterial count, including pathogens, to a safe level. Chemical
germicides that are registered with the EPA as hospital
disinfectants, when used at recommended dilutions and directions, may
be approved for sanitizing tanning devices.
15. "Sunlamp product"
means any electronic product designed to incorporate one (1) or more
ultraviolet lamps and intended for irradiation of any part of the
living human body, by ultraviolet radiation with wavelengths in air
between two hundred (200) nanometers and four hundred (400)
nanometers, to induce skin tanning.
16. "Tanning device"
means any equipment used during the process of skin tanning with a
sunlamp product, such as any sunlamp product and any accompanying
equipment, including, but not limited to, timers, ballasts, starters,
lamps, reflectors, cooling fans, acrylics, comfort pillows and
handrails.
17. "Tanning facility"
means any location, place, area, structure, or business that either
as a sole service or in conjunction with other services, provides
patrons with access to sunlamps, ultraviolet lamps or other equipment
intended to induce skin tanning through the irradiation of any part
of the human body for cosmetic or non-medical purposes.
18. "Timer" means a
device provided to terminate the exposure at a preset time interval.
19. "Ultraviolet lamp"
means any lamp that produces ultraviolet radiation in the wavelength
interval of two hundred (200) nanometers to four hundred (400)
nanometers in air and that is intended for use in any sunlamp
product.
24.5 Registration Requirements
24.5.1 Application and
Registration Fee
A. It shall be unlawful for
any person, corporation, or other entity to own, maintain, conduct,
or operate a tanning facility in Rhode Island without having been
registered with the Department pursuant to the provisions of R.I.
Gen. Laws § 23-68-6 and this Part.
B. Each tanning facility shall
be registered prior to operation. The registrant shall file an
application with the Department and pay applicable fee(s) specified
in the Fee Structure for Licensing, Laboratory and Administrative
Services Provided by the Department of Health (Part 10-05-2 of this
Title) to register each tanning facility.
1. If the registrant owns or
operates more than one (1) such tanning facility, the registrant
shall file a separate application for each tanning facility owned or
operated.
C. Registrations are issued to
one (1) person for one (1) tanning facility and are non-transferable.
D. As a requirement for
registration, each tanning facility shall maintain evidence of
holding liability insurance.
E. Registration application
shall be made on forms furnished by the Department and shall contain
all the information required by the form and accompanying
instructions.
F. A certificate of
registration will be issued by the Department upon a determination
that the applicant has provided all the information required by the
application meets the requirements of the Act and this Part, and has
paid the application fee as set forth in the Fee Structure for
Licensing, Laboratory and Administrative Services Provided by the
Department of Health (Part 10-05-2 of this Title).
1. The certificate of
registration expires annually on the 31st day of August.
2. No person shall operate or
maintain a tanning facility without a current and valid certificate
of registration.
3. The certificate shall be
displayed in a conspicuous place on the premises of the tanning
facility.
G. The registrant shall notify
the Department in writing before making any change which would render
the information contained in the application for registration or the
validation of registration no longer accurate. This requirement
shall not apply for changes involving replacement of designated
original equipment lamp types with lamps which have been certified
with the FDA as “equivalent” replacement of the lamps. The
registrant shall maintain manufacturer’s literature demonstrating
the equivalency of any replacement lamps.
24.5.2 Renewal of
Registration
A. A registration issued under
the provisions of this Part shall be for a period of no longer than
twelve (12) months and is required to be renewed annually by the
registrant.
1. A registration, unless
sooner suspended or revoked, shall expire by limitation on the 31st
day of August following its issuance. Said registration may be
renewed from year to year after approval by the Department, provided
the applicant meets the appropriate requirements of the Act and this
Part.
B. Registration renewal
application shall be made on forms furnished by the Department and
shall contain all the information required by the form and
accompanying instructions.
C. An annual tanning facility
registration renewal fee as set forth in the Fee Structure for
Licensing, Laboratory and Administrative Services Provided by the
Department of Health (Part 10-05-2 of this Title) shall accompany the
application renewal form provided by the Department.
D. The application for
registration renewals and renewal fees shall be received by the
Department on or before the expiration date of said registration.
24.5.3 Inspections
A. The Department shall make,
or cause to be made, such inspections and investigations as it deems
necessary in accordance with R.I. Gen. Laws § 23-68-5 and this Part.
B. The Department shall notify
the registrant of violations of individual standards through a
statement of deficiencies (SOD), which shall be forwarded to the
tanning facility within fifteen (15) days of the inspection team
formally exiting the tanning facility, unless the Director determines
that immediate action is necessary to protect the health, welfare, or
safety of the public or any member thereof through the issuance of an
immediate compliance order in accordance with R.I. Gen. Laws §
23-1-21.
1. A tanning facility which
received a statement of deficiencies (SOD) report must submit a plan
of corrections, signed by an authorized representative of the
registrant’s management, to the Department within fifteen (15) days
of the date of the notice of deficiencies.
C. All written reports,
statements of deficiencies and plans of correction shall be
maintained on file in each tanning facility for a period of no less
than five (5) years.
24.6 Protection of Patrons
24.6.1 Warning Statement
A. At each patron's initial
visit to a tanning facility, and at intervals not to exceed twelve
(12) months thereafter, the patron shall be provided a written
statement containing the following information to review and sign:
1. Not wearing protective
eyewear while tanning may cause injury to the eyes;
2. Overexposure to the tanning
process may cause burns;
3. Repeated exposure to the
tanning process may cause skin cancer or premature aging of the skin
or both;
4. Abnormal skin sensitivity
or burning may result from the tanning process if the patron is also
consuming or using certain:
a. Foods;
b. Cosmetics; or
c. Medications, such as
tranquilizers, antibiotics, diuretics, high blood pressure
medication, antineoplastic or birth control pills.
5. Any person taking a
prescription or over-the-counter drug should consult a physician or a
registered pharmacist before using a sunlamp product; and
6. During pregnancy, a woman
should consult with her health care provider before tanning.
B. A copy of this signed
statement shall be maintained in the patron's record, as described in
§ 24.8.3 of this Part.
C. The registrant shall be
responsible for complying with the requirements of § 24.6.1 of this
Part.
24.6.2 Warning Sign
A. Pursuant to R.I. Gen. Laws
§ 23-68-4(4), the registrant shall conspicuously post the warning
sign described in § 24.6.2(B) of this Part within one (1) meter
(39.37 inches) of each sunlamp product and in such a manner that the
sign is clearly visible, not obstructed by any barrier, equipment or
other object, and can be easily viewed by the patron before operating
the sunlamp product.
1. A similar sign containing
at least the information listed in § 24.6.2(B) of this Part that
complies with all other applicable state and federal laws, codes and
regulations may be used instead
DANGER - Ultraviolet
Radiation
Follow
instructions
Avoid
overexposure
As
with natural sunlight, overexposure may cause eye and skin injury
and allergic reactions.
Repeated
overexposure may cause premature aging of the skin and skin
cancer.
WEAR
FDA COMPLIANT PROTECTIVE EYEWEAR. FAILURE TO USE PROTECTIVE
EYEWEAR MAY RESULT IN SEVERE BURNS OR LONG-TERM INJURY TO THE
EYES.
Medications
or cosmetics may increase your sensitivity to the ultraviolet
radiation. Consult a physician before using sunlamp if you are
using medications or have a history of skin problems or believe
yourself especially sensitive to sunlight.
If
you do not tan in the sun, you are unlikely to tan from the use of
this product.
If
you believe that you have been injured by this tanning equipment,
you should contact RI Department of Health, Radiation Control
Program, 3 Capitol Hill, Room 305, Providence, RI 02908-5097
(401)
222-2566 or [email protected]
B. This warning sign shall use
upper and lower-case letters which are at least ten millimeters (0.39
inches) and five millimeters (0.20 inches) in height, as follows:
1. Pursuant to 21 C.F.R. §
878.4635(b)(6)(i)(A), the warning sign required by § 24.6.2(B) of
this Part shall also include the following statement: Attention: This
sunlamp product should not be used on persons under the age of 18
years.
24.6.3 Protective Eyewear
A. The registrant shall
require that each patron wear protective eyewear during the use of
sunlamp products.
1. The registrant shall
provide such protective eyewear, unless the patron furnishes his or
her own protective eyewear which meets the requirements of this Part.
2. Tanning facility operators
shall instruct the consumer in the proper utilization of the
protective eyewear required by § 24.6.3 of this Part.
B. The tanning facility
registrant shall ensure that patrons have the protective eyewear
required by § 24.6.3 of this Part before each tanning session and
shall make a reasonable effort to ensure that this eyewear is worn
during tanning.
C. The protective eyewear
required by § 24.6.3 of this Part shall meet the requirements of 21
C.F.R. § 1040.20(c)(4).
D. Any reusable protective
eyewear furnished by the registrant shall be sanitized in accordance
with § 24.7.1(B) of this Part.
24.6.4 Policy and
Procedural Requirements Related to Patron Safety
A. The registrant shall
maintain a list of the common photosensitizing agents as provided by
the FDA, or other appropriate authorities, available for review by
patrons.
B. At each tanning facility,
the registrant shall keep a list of emergency contact numbers
appropriate for the community in which the facility is located. This
list shall be easily accessible and shall include, but not be limited
to, contact numbers for:
1. The nearest hospital;
2. The nearest fire
department; and
3. Emergency 911 service.
C. At least one (1) trained
staff member is required on-site at all times when the tanning
facility is in operation.
D. Only one (1) patron may be
in a tanning room at one (1) time, with the following exceptions:
1. If two (2) or more sunlamp
products are used in the same room, in which case only those patrons
using sunlamp products may be present in the room; and
2. If a patron using a sunlamp
product needs aid or assistance from another person, in which case
that individual shall also be provided with and wear protective
eyewear.
E. Exposure of Minors
1. No patron under the age of
eighteen (18) shall be allowed to use a sunlamp product.
2. Infants and other minors
are not permitted to be in the sunlamp product room during exposure
of parents or guardians.
F. Exposure Limits and Other
Controls against Overexposure
1. The registrant shall ensure
that each patron using a sunlamp product shall be instructed on the
maximum exposure time and proper exposure distance, as recommended by
the manufacturer of the product.
2. The registrant shall ensure
that each patron does not exceed the maximum exposure time indicated
by the sunlamp product manufacturer.
a. The registrant shall limit
exposure time to the recommended maximum exposure time provided by
the product manufacturer on the sunlamp product or in the product
operating manual. The maximum exposure time recommended by the
manufacturer of the product shall not be exceeded in any twenty-four
(24)-hour period.
b. Initial tanning sessions
(three (3) to five (5)) are limited to one (1) tanning session per
forty-eight (48)-hour period or as recommended by the sunlamp product
manufacturer, whichever is less frequent, to allow adequate time for
melanin activation and transit to occur prior to subsequent
exposures. Patrons shall be advised of the manufacturer's recommended
exposure schedule as posted on the sunlamp product or listed in the
operating manual for the product prior to the initial tanning
sessions.
c. After the initial (three
(3) to five (5)) tanning exposures, tanning sessions are limited to
one (1) tanning session per twenty-four (24)-hour period or as
recommended by the sunlamp product manufacturer, whichever is less
frequent. Patrons shall be advised of the manufacturer's exposure
schedule as posted on the sunlamp product or listed in the operating
manual for the sunlamp product prior to tanning.
d. For patrons with annual
tanning packages, package maximums shall not exceed the maximum
amount of exposure recommended by the product manufacturer.
3. Tanning facilities are
prohibited from controlling the use of sunlamp products with token
timer control systems, in the absence of trained staff.
4. The registrant shall ensure
that the patron is instructed as to the location and proper operation
of the sunlamp product's emergency shut-off switch.
5. The registrant shall
establish and use a procedure manual that will aid in the protection
of the patron from excessive or unnecessary exposure to ultraviolet
light.
a. This manual shall be
specific to the facility and shall include at least documentation of
the requirements detailed in this Part.
b. A copy of this manual shall
be kept on-site and readily available at all times when the tanning
facility is in operation.
c. This procedure manual may
be developed as part of the training manual described in § 24.8.2 of
this Part, provided the above requirements are met.
24.7 PHYSICAL PLANT AND EQUIPMENT
24.7.1 CONSTRUCTION,
SANITATION AND MAINTENANCE OF TANNING FACILITIES
A. Each tanning facility shall
be constructed to meet the following minimum requirements:
1. All tanning facilities
shall be equipped with convenient toilet facilities and dressing
rooms. At a minimum, such toilet facilities shall include a water
closet, a hand-washing sink and a safe and sanitary supply of water.
Such toilet and dressing rooms shall be properly maintained, as well
as meet all federal, state and local laws, codes and regulations.
2. The sunlamp products shall
meet the requirements of § 24.7.2 of this Part and all other
applicable federal and state requirements.
3. The physical facility shall
be constructed such that:
a. All areas of the tanning
facility shall be ventilated with at least six (6) air changes per
hour or as otherwise required by local code; and
b. Tanning booth temperature
shall be maintained below one hundred (100) degrees Fahrenheit
(thirty- eight (38) degrees Centigrade) during sunlamp product
operation.
4. Except as otherwise
required by this Part, each tanning facility shall be constructed in
accordance with all applicable local and state codes.
B. Each tanning facility shall
be cleaned and maintained to meet the following minimum requirements:
1. All areas of the tanning
facility, including tanning devices, equipment and apparatus, shall
be maintained in a clean and sanitary manner and in accordance with
manufacturer's instructions.
2. The tanning device(s) and
protective eyewear shall be cleaned with an EPA-approved sanitizer
after each use, unless the facility provides sanitary disposable
clear plastic sheets for application before and disposal after each
patron use of a tanning device. Suitable written instructions shall
be posted to provide adequate guidance to patrons using sanitary
sheets.
a. Facilities using disposable
clear plastic sheets to cover the surface of a tanning device shall
be required to clean and sanitize those tanning devices periodically
throughout each day the tanning devices are being used by patrons.
b. Disposable eyewear designed
for one (1) use only are exempt from this requirement provided that
they are disposed of and not reused by any other patron.
c. Tanning devices shall be
cleaned and sanitized according to the following minimum provisions:
(1) A clean paper or cloth
towel shall be used each time the tanning device is cleaned and
sanitized;
(2) The sanitizer used shall
be one specifically manufactured for sanitizing ultraviolet
light-emitting equipment and protective eyewear and that does not
damage the acrylic lamp covers of the sunlamp product.
(3) The ultraviolet light
produced by a sunlamp product itself is not considered an adequate
sanitizing agent.
3. A test kit or other device
that accurately measures the concentration of the sanitizing solution
in parts per million (ppm) shall be used to measure the strength of
the sanitizing solution when the concentrate and water dilution is
initially prepared and at least weekly thereafter to ensure
sufficient strength of the sanitizing solution.
a. If a suitable test kit is
not available for an approved sanitizer, the laboratory analysis data
shall be provided by the product manufacturer, and a copy shall be on
file with the Department.
4. Written procedures
maintained at the facility shall include proper mixing and handling
instructions for each sanitizer used, so as to ensure proper
concentration of the sanitizer.
5. Except as otherwise
required by this Part, each tanning facility shall be cleaned and
maintained in accordance with all applicable local and state codes.
C. Clean sanitary towels shall
be available to all patrons using tanning facilities.
D. A hamper or other
receptacle shall be provided for all soiled towels and linen.
E. No pets or other animals
shall be permitted in tanning rooms at any time, other than seeing
eye dogs or hearing assistance dogs.
24.7.2 EQUIPMENT
A. The registrant shall use
only sunlamp products manufactured in accordance with the
specifications set forth in 21 C.F.R. §1040.20. Sunlamp products
which do not meet the provisions of 21 C.F.R. § 1040.20 shall not be
operated.
1. The sunlamp products shall
meet the National Fire Protection Association's National Electrical
Code, or be approved by the Underwriter Laboratories (UL) or
Electrical Testing Laboratories (ETL). Compliance shall be based on
the standard in effect at the time of manufacture as shown on the
device identification label required by 21 C.F.R. § 1010.3.
B. Each sunlamp product or
ultraviolet lamp used in tanning facilities shall not emit measurable
ultraviolet C radiation.
C. Each ultraviolet lamp
contained within the sunlamp product shall be shielded so as to not
come into contact with the patron.
D. The construction of the
sunlamp product shall be such that it will have the strength to
withstand the stress of use and the impact of a falling person.
1. Entry to stand-up sunlamp
products shall be of rigid construction with doors which are
non-locking and open outwardly.
E. The appropriate position
the patron is to assume prior to operation shall be clearly marked on
each sunlamp product.
F. Each sunlamp product shall
prominently display a label which contains the information required
by § 24.6.2(B) of this Part or an equivalent warning/information
label.
G. Reasonable means shall be
provided to enable a patron to summon assistance from the exposure
position.
H. Original Equipment
Manufacturer (OEM) replacement parts (or their equivalent) shall be
used, if available, to prevent UL/ETL de-listing of sunlamp products.
All local, state and national electrical codes shall be observed
during installation.
I. Defective or non-lighting
filters or lamps at the end of their useful UV-emitting life shall be
replaced with a type intended for use in the sunlamp product, shall
be of the same ultraviolet range (A or B) as specified by the
manufacturer, and shall be the original lamp type as specified by the
manufacturer, or shall be certified as an equivalent lamp per 21
C.F.R. § 1040.20(c)(5).
1. If equivalent lamps are
used instead of the required OEM lamps, a copy of the equivalency
certification provided by the lamp supplier shall be maintained on
file for review by the Department.
J. Defective or burned out
tanning lamps and tanning lamps which have been operated in a sunlamp
product for the manufacturer's maximum rated lamp hour life shall be
disposed of in a safe and proper manner to prevent unauthorized and
unsafe use as lighting devices. Used tanning lamps are prohibited
from being resold for any purpose.
K. Each sunlamp product shall
have a timer which complies with the requirements of 21 C.F.R. §
1040.20(c)(2).
1. The maximum timer interval
shall not exceed the manufacturer's maximum recommended exposure
time.
2. Each timer shall be
functional and accurate to within ±10% of the maximum timer interval
of the product as required by 21 C.F.R. § 1040.20(c)(2)(iii).
3. The registrant shall ensure
that the timer is tested for accuracy at intervals not to exceed
twelve (12) calendar months.
4. Sunlamp product timers
shall be controlled by properly trained staff.
5. Tanning facilities shall
install remote timer controls prior to the operation of sunlamp
products.
6. The time shall not
automatically reset and cause radiation emission to resume for a
period greater than the unused portion of the timer cycle when
emission from the tanning device has been interrupted.
L. In addition to a timer,
each sunlamp product shall be equipped with a control on the product
to enable the person being exposed to terminate manually radiation
emission from the product at any time without disconnecting the
electrical plug or removing the ultraviolet lamp, as required by 21
C.F.R. § 1040.20(c)(3).
M. The minimum requirements of
the manufacturer shall be maintained for all sunlamp products.
N. Each sunlamp product shall
be equipped with an hour meter to accurately determine lamp hour use.
1. Lamp hour use as indicated
by the hour meter shall be recorded at each episode of maintenance
service for each product, as specified in § 24.8.3(H)(3) of this
Part.
24.8 ADMINISTRATIVE REQUIREMENTS
24.8.1 GENERAL
ADMINISTRATIVE REQUIREMENTS
A. The registrant shall be
responsible for directing the operation of the tanning facility which
has been registered with the Department. That registrant shall
assure that the provisions of this Part are met in the operation of a
tanning facility.
B. The registrant shall ensure
that the tanning facility complies with all applicable federal, state
and local codes, laws and regulations.
C. Each registrant shall
establish and maintain a tanning facility specific electronic mail
address (i.e., e-mail address) to be provided to the Department for
the purposes of contacting the registrant with both routine
communications and emergency notices. The registrant shall be
responsible for providing notice to the Department at any time that
the tanning facility’s specific electronic mail address is changed
or updated.
24.8.2 TRAINING OF
PERSONNEL
A. The registrant shall
certify that all tanning facility staff are adequately trained and
have been issued a training manual established for that facility.
This training and manual shall include, but not be limited to,
coverage of the following provisions:
1. The requirements of this
Part;
2. Procedures for correct
operation of the tanning facility and sunlamp products;
3. Guidelines for the
recognition of injury or overexposure to ultraviolet radiation;
4. The sunlamp product
manufacturer's procedures for operation and maintenance of the
sunlamp products;
5. Guidelines for the
determination of skin type of customers and appropriate determination
of duration of exposure to sunlamp products;
6. Procedures for the use of
patron consent forms;
7. Emergency procedures to be
followed in case of injury;
8. Potential photosensitizing
foods, cosmetics, and medications;
9. Requirements for the proper
use of protective eyewear;
10. Proper sanitizing
procedures for eyewear, facility, and devices; and
11. Instructions for use of
sunlamp product to avoid or to minimize potential injury to the
patron, as required by 21 C.F.R. § 1040.20(e).
B. The registrant may use
vendor-provided information in establishing the facility's training
manual, provided that this material contains all of the above
information.
C. Staff training shall be
documented by the registrant. Such documentation shall include the
dates and times of the training, as well as the subjects covered in
each training session
D. Tanning equipment shall
only be operated when a trained tanning operator is present at the
tanning facility.
24.8.3 RECORDS AND REPORTS
A. The registrant shall be
responsible for maintaining all records as described in this Part.
B. All required records shall
be maintained at the tanning facility for a minimum of three (3)
years and shall be available for review by the Department.
C. All required records may
also be completed, transmitted, and stored in electronic media with
the capability for producing legible, accurate, and complete copies
of the records. If records are stored electronically, they shall be
maintained in a manner that will allow retrieval of records for any
specified time period.
D. Patron Records
1. The registrant shall
maintain a record of each patron's total number of tanning visits,
dates and durations of tanning exposures.
2. The registrant shall
maintain a record of each patron's signature and acknowledgment that
he/she understands the potential risks involved with exposure and
overexposure to ultraviolet radiation and he/she has reviewed a
photosensitizing drug list.
E. Within five (5) working
days after occurrence or knowledge thereof, the registrant shall
submit to the Department a written or electronic report of each
actual or alleged accident or injury that results from the use of
registered sunlamp products for which medical attention was sought or
obtained. The report shall include:
1. The name of the affected
individual(s);
2. The name, location and
phone number of the tanning facility involved;
3. The nature of the actual or
alleged injury(ies); and
4. Any other information
relevant to the actual or alleged injury(ies) to include the date and
duration of exposure and any documentation of medical attention
sought or obtained.
F. The registrant shall
maintain a record of staff training as required in § 24.8.1 of this
Part.
G. The registrant shall
maintain records showing the results of timer tests required by §
24.7.2(K)(3) of this Part.
H. The registrant shall
maintain the following information for each sunlamp product:
1. Manufacturer's equipment
manual and any other service-related material or instruction;
2. The exposure schedule
provided by the manufacturer; and
3. Records of surveys,
inspections, maintenance and modifications performed on the sunlamp
product, including the names of persons performing such services, the
date of service and the hour meter reading of the product serviced.
I. The registrant shall
maintain records showing the receipt, transfer, repair and disposal
of all sunlamp products and lamps.
24.8.4 ADVERTISING AND
PROMOTION
A. No person or establishment
registered under the Act and this Part shall use or cause or promote
the use of any advertising, promotional literature, testimonial,
guarantee, warranty, label, brand, insignia or any other
representation, however disseminated or published, which is
misleading, deceptive or untruthful.
B. No person or facility shall
advertise or promote tanning packages labeled as "unlimited"
unless information regarding maximum exposure schedules is included
in such advertisements.
1. Promotion of annual tanning
packages shall include a written statement listing the total number
of sessions allowed per person per year, as listed in § 24.6.4(F)(2)
of this Part.
24.9 PENALTIES, PRACTICES AND
PROCEDURES
24.9.1 DENIAL, REVOCATION
OR SUSPENSION OF REGISTRATION
A. The Department is
authorized to deny an application for the issuance of a registration
or to revoke or suspend any registration issued if the provisions of
the Act and this Part are not met.
B. Whenever an action shall be
proposed to deny, revoke or suspend a registration, the Department
shall notify the applicant by certified mail, setting forth reasons
for the proposed action. The applicant shall be given an opportunity
for a prompt and fair hearing, in accordance with Practices and
Procedures before the Rhode Island Department of Health (Part 10-05-4
of this Title).
C. If the Department finds
that the public health, safety or welfare of the public requires
emergency action and incorporates a finding to that effect in its
order, the Department may order summary suspension of a registration
pending proceedings for revocation or other action in accordance with
RI Gen. Laws §§ 42-35-14(c) and 23-1-21.
24.9.2 VIOLATIONS AND
PENALTIES
Penalties for violations are
in accordance with R.I. Gen. Laws § 23-68-7.