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

Current through Reg. 49, No. 28; July 12, 2024
(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.