Texas Administrative Code
Title 25 - HEALTH SERVICES
Part 1 - DEPARTMENT OF STATE HEALTH SERVICES
Chapter 229 - FOOD AND DRUG
Subchapter T - LICENSURE OF TANNING FACILITIES
Section 229.351 - Tanning Devices

(a) Only tanning devices manufactured and certified to comply with 21 Code of Federal Regulations (CFR), Part 1040, §1040.20, "Sunlamp products and Ultraviolet Lamps Intended for Use in Sunlamp Products", shall be used by or sold to tanning facilities. Tanning devices that have been reconditioned must comply with federal and state requirements. Tanning device reconditioners must be licensed under the Texas Food, Drug, Device, and Cosmetic Salvage Act, Health and Safety Code, Chapter 432. Compliance shall be based on the standard in effect at the time of manufacture as shown on the device identification label required by 21 CFR, Part 1010, §1010.3. Tanning devices must also comply with the medical device labeling requirements of 21 CFR, Part 801.

(b) All tanning devices shall have a timer which complies with the requirements of 21 CFR, Part 1040, §1040.20(c)(2). The maximum timer interval shall not exceed the manufacturer's maximum recommended exposure time for the device. No timer interval shall have an error greater than plus or minus 10% of the maximum timer interval for the product.

(c) The operator shall limit the exposure time of a customer on a tanning device to the maximum exposure time recommended by the manufacturer, taking the customer's skin type into consideration.

(d) Tanning device remote timers shall be installed and located so that the customer may not set or reset the customer's own exposure time. Remote timer systems must comply with the requirements for timers as provided in subsection (b) of this section.

(e) No operator shall sell, or otherwise make available to any user of a tanning device, tokens required to operate the tanning device in quantities greater than the tanning device manufacturer's maximum recommended exposure time for the user.

(f) The operator shall control the temperature of the customer contact surfaces of a tanning device and the surrounding area so that it will not exceed 100 degrees Fahrenheit.

(g) The tanning devices shall be maintained in good repair.

(h) Defective or burned-out lamps or filters shall be replaced with a type intended for use in that device as specified on the device label, or with lamps or filters that are "equivalent" under the United States Food and Drug Administration (FDA) regulations and policies applicable at the time of lamp manufacture. The facility operator shall maintain lamp manufacturer's user instruction labeling at the facility, demonstrating the equivalence of any replacement lamps, if applicable.

(i) A tanning device used by a tanning facility must comply with all applicable state and local electrical code requirements.

(j) When a tanning device is being used by an individual, no other person shall be allowed to remain in the tanning device area.