No tanning equipment shall be installed in any tanning facility, unless the equipment and facilities have been found to be in compliance with the following standards:
(A) Each tanning bed shall be located in a separate room with a lockable door, and with non-transparent walls of a significant height to provide privacy;
(B) Each sunlamp product shall incorporate a timing device with multiple timer settings adequate for the manufacturer's recommended exposure intervals to produce the expected results;
(C) Each assembly of tanning equipment shall be equipped with a timer which complies with the requirements of 21 CFR part 1040, Section 1040.20(C)(2), revised as of April 1, 2012 and cited as 21 CFR 1040.20. The maximum timer interval shall not exceed the manufacturer's maximum recommended exposure time. No timer interval shall have an error exceeding plus or minus ten per cent of the maximum timer interval for the product. Each new tanning facility shall install remote timer controls such that clients who are tanning cannot reset the timer .
(D) Each sunlamp product shall incorporate within arm's reach of a user a control on the product to enable the user to manually terminate radiation without pulling the electrical plug or coming in contact with the ultraviolet lamp;
(E) The permit holder shall provide protective eyewear to each individual seeking to use the sunlamp product. This protective eyewear shall meet the requirements of Section 1040.20(C)(5), revised as of April 1, 2012 and cited as 21 CFR part 1040.20. The permit holder shall ensure that before each use, the protective eyewear required by this rule is properly disinfected as described in rule 4713-19-06 of the Administrative Code, is not altered in any way, and shall not rely upon the exposure of the protective eyewear to the ultraviolet radiation produced by the tanning equipment itself to provide such sanitizing and be adequate for the protection of the individual's eyes;
(F) Each ultraviolet lamp contained within the sunlamp product shall be shielded so as to prevent the lamp from having any contact with the individual using the sunlamp product. Transparent covers shall be used to shield each ultraviolet lamp contained within the sunlamp product. The covers shall not contain substantial cracks or breaks in or on any surface. Each shield must be similar in size and material to the original manufacturer's installed shield;
(G) Each booth-type sunlamp product shall provide a handrail for use during operation of the tanning facility.
(H) Each tanning facility shall provide clear instructions on the correct body position required to use the sunlamp product;
(I) Each sunlamp product shall be housed in a separate room, except when the sunlamp product also incorporates a dressing area in its design;
(J) A sunlamp product that is designed to automatically skin type each individual and its sensor shall not be altered . The operator shall insure that the sensor is used only by the individual who is tanning in order that the sunlamp product correctly skin types that specific individual;
(K) Each sunlamp product shall prominently display the following label: "Danger - ultraviolet radiation. Follow instructions carefully. Do not enter without protective eyewear." The label shall be colored or marked so that it stands out, but remains easy to read;
(L) Each tanning facility shall be so equipped to dissipate heat so that the interior temperature does not exceed one hundred degrees fahrenheit or thirty-four degrees centigrade. Every tanning room within the facility shall have a thermometer mounted at five feet above the floor. Adjacent to the thermometer shall be a sign that uses the following wording: " Individuals shall not tan if temperature is at one hundred degrees or higher! Please report excessive heat to the operator immediately!";
(M) The permit holder shall replace ultraviolet lamps, bulbs, and filters at such frequency or after such duration of use as may be recommended by the manufacturer of such lamps, or bulbs, or filters; and these items shall be replaced as soon as they become defective or damaged. Only those lamps, bulbs or filters, meeting the requirements of the United States food and drug administration for any particular sunlamp product, or a certified compatible lamp may be used in the operation of the particular sunlamp product. Lamps used in sunlamp products must either be the original manufacturer's lamp or must be compatible with the sunlamp product's original manufacturer label. The facility shall maintain the manufacturer's lamps, or must be compatible with the sunlamp product's original manufacturer label. The facility shall maintain the manufacturer's recommendations for lamps, bulbs or filters on file in the facility and shall produce copies of the lamp compatibility sheets when inspected or investigated. Electronic versions of lamp compatibility are acceptable;
(N) A tanning facility shall maintain a lamp compatibility sheet as required in paragraph (M) of this rule; Should the inspector or investigator not be able to easily read the labels on the lamps, the facility owner or certified operator shall remove the shielding in order to allow an inspector or investigator from the board to easily verify UV bulb compatibility or shall take out the lamp for inspection. Each sunlamp product shall have the UV bulbs installed so that the bulb information is readily available for the board inspector to verify that information on the bulb matches the manufacturer's recommended bulb list;
(O) Each sunlamp product and any replaceable bulb for that product shall not be altered or modified from the manufacturing specifications of the original product or used for purposes other than those permitted under the FDA regulations set forth in 21 CFR part 1040, Section 1040.20, revised as of April 1, 2012 and cited as 21 CFR 1040.20, and
(P) Each tanning facility shall comply with all other applicable statutes and rules governing tanning equipment.
Five Year Review (FYR) Dates: 11/01/2018
Promulgated Under: 119.03
Statutory Authority: 4713.08
Rule Amplifies: 4713.08, 4713.41
Prior Effective Dates: 12/17/89, 1/26/97, 1/17/02, 1/10/04, 5/1/04, 11/1/13