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 tanning 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 FDA compliant 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 sunlamps, indoor tanning beds or booths 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. A consumer notification providing the consumer the name and address of the Agency so that in case of an injury the consumer can contact the Agency. i. Only tanning equipment manufactured and certified to comply with 21 CFR Part 1040, Chapter 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. Part 14: General Sanitation November 11, 2011 j. 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. k. The timer shall not automatically reset and cause radiation emission to resume for a period of greater than the unused portion of the timer cycle when emission from the tanning device has been interrupted. l. Each tanning device shall be equipped with a user or consumer accessible on/off switch and an emergency shut-off mechanism to allow manual termination of the UV exposure as required by 21 CFR 1040.20(c)(3). m. Each tanning device shall have labels as noted in 21 CFR 1040.20(d)(1)(i- vi). n. Tanning equipment shall meet the National Fire Protection Association's National Electrical Code. o. There shall be physical barriers to protect consumers from injury induced by touching or breaking the lamps. p. 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. q. Tanning equipment electrical circuitry shall be approved by the Underwriter Laboratories (UL) or Electrical Testing Laboratories (ETL). 2. Protective Eyewear a. Each consumer shall be provided with protective eyewear and instructions for their use. b. Protective eyewear shall meet the requirements of 21 CFR Part 1040, Section 1040.20 (c)(4). c. Protective eyewear shall be properly sanitized before each use with a sanitizing agent which is registered by the EPA and mixed to the appropriate Part 14: General Sanitation November 11, 2011 concentration. Exposure to the ultraviolet radiation produced by the tanning equipment itself is not considered a sanitizing agent. d. Tanning facility operators shall instruct the consumer in the proper utilization of the protective eyewear required by this section and each consumer shall wear the protective eyewear as instructed. 3. Operation a. A tanning registrant shall only allow operation of the tanning equipment by those who have successfully completed a formal operator training course that has been pre-approved by the Agency. b. Tanning equipment shall only be operated when a trained tanning operator is present at the tanning facility. c. Prior to initial exposure each consumer shall be provided the opportunity to read a copy of the warning specified in 6.1.12 (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. d. A record shall be kept by the facility operator of each consumer's total number of tanning visits and total accumulated exposure times. e. 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 and circumstance of the alleged injury; iv. The name and address of health care provider, if any; and v. Any other information considered relevant to the situation. f. No consumer under fourteen years of age shall be allowed to use a tanning device at a tanning facility unless the child’s parent or legal guardian has provided written consent to the tanning facility and the parent or guardian is physically present at the facility the entire time the child uses the tanning device. The parent or guardian shall sign the consent form in the presence of the operator of the tanning facility and that consent may be revoked at any time by the parent or guardian. The parent or guardian shall be provided with the basic information required under 6.1.12. Part 14: General Sanitation November 11, 2011 g. Consumers fourteen years of age or older but under eighteen years of age shall not be allowed to use a tanning device at a tanning facility unless the child’s parent or legal guardian has provided written consent to the tanning facility. The parent or guardian shall sign the consent form in the presence of the operator of the tanning facility and that consent may be revoked at any time by the parent or guardian. The parent or guardian shall be provided with the basic information required under 6.1.12. h. Defective or burned-out lamps or filters or lamps at the end of their useful UV emitting life 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. i. Each operator must be adequately trained by a pre-approved formal training course as required by the Agency. 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 overexposure or injury; vi. written material which covers the required subjects, such as a training manual; audio-visual presentations which cover the required subjects such as slides or videos; copies of the regulations and Title 21 CFR 1040.20; and a question and answer period for trainees; vii. procedures for correct cleaning, sanitizing and operation of the tanning device including proper care and use of protective eyewear; viii. biological effects of ultraviolet radiation, maximum allowable time of exposure, photosensitivity and determination of human skin types as it relates to compliant us of the FDA recommended exposure schedule; ix. review and explanation of the lamp compatibility for tanning equipment. j. A list of operators trained in accordance with 6.1.12(3)(i) shall be maintained and available at the facility. Part 14: General Sanitation November 11, 2011 k. A list of photosensitizing agents shall be posted in each area where tanning equipment is located and shall be explained to the consumer on their initial visit and periodically.