Section R12-1-1413. Tanning Equipment Standards

A.      A registrant operating a tanning facility shall use sunlamp products that are certified by the manufacturer to comply with 21 CFR 1040.20, April 1, 2004, which is incorporated by ref- erence, published by the Office of Federal Register National Archives and Records Administration, Washington, D.C. 20408, and on file with the Agency. This incorporation by ref- erence contains no future editions or amendments. For sun- lamp products in use before the effective date of this Article, the Agency shall determine compliance based on the standard in effect at the time of manufacture, as shown on the equip- ment identification label.

B.       A registrant shall replace burned-out or defective lamps or fil- ters, before any use of a tanning device.

C.      A registrant shall replace a burned-out or defective lamp or fil- ter with a lamp or filter intended for use in that equipment, as specified on the sunlamp product label, or that is equivalent to a lamp or filter specified on the sunlamp product label under the FDA regulations and polices applicable to the sunlamp product at the time of manufacture. If an equivalent lamp or filter is used instead of the Original Equipment Manufacturer (OEM) lamp or filter specified on the product label, the regis-

trant shall maintain a copy of the equivalency certification, provided by the lamp supplier, on file for review by Agency inspectors.

D.      A registrant shall ensure that each sunlamp product has a timer and control system that complies with 21 CFR 1040.20(c), April 1, 2004, which is incorporated by reference, published by the Office of Federal Register National Archives and Records Administration, Washington, D.C. 20408, and on file with the Agency. This incorporation by reference contains no future editions or amendments. In addition the registrant shall ensure that:

1.        The timer interval does not exceed the manufacturer’s maximum, recommended exposure time;

2.        The timer is functional and accurate to within +/- 10% of the maximum timer interval of the product;

3.        The timer does not automatically reset and cause radia- tion emission to resume for a period greater than the unused portion of the timer cycle;

4.        The timer is tested annually for accuracy;

5.        For a new facility (including existing facilities with change of ownership) a remote timer control system is installed before operation of sunlamp products. For an existing facility that has sunlamp products not equipped with a remote timer control system, a remote timer con- trol system (outside of the sunlamp product room) is installed no later than 6 months after the effective date of this Section; and

6.        Each sunlamp product is equipped with an emergency shutoff mechanism that allows manual termination of the UV exposure by the user.

E.       A registrant shall provide physical barriers between each sun- lamp product to protect users from injury caused by touching or breaking a lamp.

F.       A registrant that employs a stand-up sunlamp product shall:

1.        Use physical barriers, handrails, floor markings, or other methods to indicate the proper exposure distance between the ultraviolet lamps and the user’s skin;

2.        Construct each tanning booth so that it can withstand the stress of use and the impact of a falling person;

3.        Provide access to a tanning booth with doors of rigid con- struction that open outward, handrails, and non-slip floors; and

4.        Control the interior temperature of a sunlamp product so that it never exceeds 100 degrees Fahrenheit (38 degrees Centigrade).

Historical Note

Adopted effective April 2, 1990 (Supp. 90-2). Amended

effective January 2, 1996 (Supp. 96-1). Amended by final

rulemaking at 11 A.A.R. 61, effective February 5, 2005

(Supp. 04-4).