Construction and Operation of Tanning Facilities

Construction and Operation of Tanning Facilities. Unless otherwise ordered or approved by the Agency, each tanning facility shall be constructed, operated, and maintained to meet the following minimum requirements: 1. Physical facilities a. The following warning sign shall be posted in the immediate proximity (within 1 meter) of each piece of tanning equipment and it shall be readily legible, clearly visible, and not obstructed by any barrier, equipment, or other item present so that the user can easily view the warning sign before energizing the ultraviolet light generating equipment: DANGER - ULTRAVIOLET RADIATION b. Follow instructions. c. Avoid overexposure. As with natural sunlight, overexposure can cause eye and skin injury and allergic reactions. Repeated exposure may cause premature aging of the skin and skin cancer. d. Wear protective eyewear. e. FAILURE TO USE PROTECTIVE EYEWEAR MAY RESULT IN SEVERE BURNS OR LONG-TERM INJURY TO THE EYES. f. 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. g. If you do not tan in the sun, you are unlikely to tan from the use of this product. h. The lettering on each warning sign shall be at least ten (10) millimeters high for all words showing in capital letters and at least five (5) millimeters high for all lowercase letters. i. Only tanning equipment manufactured and certified to comply with 21 CFR Part 1040, Chapter j. 1040.20, "Sunlamp products and ultraviolet lamps intended for use in sunlamp products", shall be used in tanning facilities. 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, Chapter 1010.3. k. Each tanning equipment shall have a timer which complies with the requirements of 21 CFR Part 1040, Chapter 1040.20(c) (2). The maximum timer interval shall not exceed the manufacturer's maximum recommended exposure time. No timer interval shall have an error greater than ± 10% of the maximum timer interval for the product. l. Tanning equipment shall meet the National Fire Protection Association's National Electrical Code. m. There shall be physical barriers to protect consumers from injury induced by touching or breaking the lamps. n. Additional requirements for stand-up booths: i. there shall be physical barriers or other means such as handrails or floor markings to indicate the proper exposure distance between ultraviolet lamps and the consumer's skin. ii. the construction of the booth shall be such that it will withstand the stress of use and the impact of a falling person. iii. access to the booth shall be of rigid construction. Doors shall open outwardly. Handrails and nonslip floors shall be provided. o. Tanning equipment electrical circuit shall be approved by the Underwriter Laboratories (UL) or Electrical Testing Laboratories (ETL). 2. Protective goggles a. Each consumer shall be provided with protective goggles and instructions for the use. b. Protective goggles shall meet the requirements of 21 CFR Part 1040, Section 1040.20 (c) (5). c. Protective goggles shall be properly sanitized before each use. Exposure to the ultraviolet radiation produced by the tanning equipment itself is not considered a sanitizing agent. d. Each consumer shall wear the protective goggles as instructed. 3. Operation a. An operator must be present when tanning equipment is operated. b. Prior to initial exposure each consumer shall be provided the opportunity to read a copy of the warning specified in 2.1.12 (1) (a). The operator shall then request that the consumer sign a statement that the information has been read and understood. For illiterate or visually handicapped persons, the warning statement shall be read by the operator in the presence of a witness. Both the witness and the operator shall sign the statement. c. A record shall be kept by the facility operator of each consumer's total number of tanning visits and tanning times. d. A written report of any tanning injury shall be forwarded to the Agency within five [5] working days of the occurrence or knowledge thereof. The report shall include: i. the name of the affected individual; ii. the name and location of the tanning facility involved; iii. the nature of the injury; and iv. name and address of health care provider, if any; v. any other information considered relevant to the situation. e. No consumer under sixteen years of age shall be allowed to use the tanning facility unless he or she provides a consent form signed by the parent or legal guardian. The parent or guardian shall have been provided with the basic information required under 2.1.12. f. Defective or burned-out lamps or filters shall be replaced with a type intended for use in that device as specified on the product label on the tanning equipment, or, with lamps or filters that are "equivalent" under the FDA regulations and policies applicable at the time of lamp manufacture. g. Each operator must be adequately trained. Proof of training must be maintained in the facility and available for inspection. Training shall include: i. the requirements of these regulations; ii. procedures for correct operation of the facility; iii. recognition of injury or overexposure; iv. manufacturer's procedures for operation and maintenance of tanning equipment; v. emergency procedures in case of injury. vi. A list of operators trained in accordance with 2.1.12 (3) (g) shall be maintained and available at the facility.