641—46.5 (136D) Construction and operation of tanning facilities. Unless otherwise ordered or approved by the department, each tanning facility shall be constructed, operated, and maintained to meet the following minimum requirements:
	 46.5(1) A tanning facility shall provide and post the following warning signs and statements that describe the hazards associated with the use of tanning devices:
	  a.   	 A warning sign in a conspicuous location readily visible to persons entering the establishment. This warning sign shall use 0.5-inch (12.7-millimeter) letters for “DANGER, ULTRAVIOLET RADIATION” and 0.25-inch (6.4-millimeter) letters for all other lettering. The sign shall use red lettering against a white background, be at least 9.0 inches by 12.0 inches (22.9 centimeters × 30.5 centimeters) and have the following wording:
_______________________________________________________________________________
DANGER
ULTRAVIOLET RADIATION
— Overexposure can cause
	  ● 	 Eye and skin injury
	  ● 	 Allergic reaction
— Repeated exposure may cause
	  ● 	 Premature aging of the skin
	  ● 	 Skin cancer
— Failure to wear protective eyewear may result in
	  ● 	 Severe burns to eyes
	  ● 	 Long-term injury to eyes
— Medication or cosmetics may increase your sensitivity
_______________________________________________________________________________
	  b.   	 A warning sign with the identical wording set forth in 46.5(1)“a” posted within one meter of the tanning device in a conspicuous location readily visible to a person preparing to use the device. This warning sign shall use 0.5-inch (12.7-millimeter) letters for “DANGER, ULTRAVIOLET RADIATION” and 0.25-inch (6.4-millimeter) letters for all other lettering. The sign shall use red lettering against a white background and be at least 6 inches by 9 inches (15.2 centimeters × 22.9 centimeters) in size.
	  c.   	 A tanning facility shall require each consumer to read the information in Appendices 1, 2, and 3 prior to the consumer’s initial exposure and annually thereafter.
	 (1) 	 The operator shall then require the consumer to sign a statement that the information has been read and understood.
	 (2) 	 The information in Appendices 1, 2, and 3 shall be posted in each tanning room.
	 46.5(2) Federal certification.
	  a.   	 Only tanning devices manufactured and certified under the provisions of 21 CFR Part 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 Parts 1010.2 and 1010.3.
	  b.   	 Labeling shall meet the following requirements, be visible on each unit and be permanently affixed. Labeling shall include:
	 (1) 	 A warning statement with the words “DANGER-Ultraviolet radiation. Follow instructions. 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. WEAR PROTECTIVE EYEWEAR; FAILURE TO MAY RESULT IN SEVERE BURNS OR LONG-TERM INJURY TO THE EYES. Medications or cosmetics may increase your sensitivity to the ultraviolet radiation. Consult a physician before using a sunlamp if you are using medications or have a history of skin problems or believe yourself especially sensitive to sunlight. If you do not tan in the sun, you are unlikely to tan from the use of this product.”
	 (2) 	 Recommended exposure position(s). Any exposure position may be expressed either in terms of a distance specified both in meters and in feet (or in inches) or through the use of markings or other means to indicate clearly the recommended exposure position.
	 (3) 	 Directions for achieving the recommended exposure position(s) and a warning that the use of other positions may result in overexposure.
	 (4) 	 A recommended exposure schedule including duration and spacing of sequential exposures and maximum exposure time(s) in minutes.
	 (5) 	 A statement of the time it may take before the expected results appear.
	 (6) 	 Designation of the ultraviolet lamp type to be used in the product.
	 46.5(3) Tanning device timers.
	  a.   	 Each tanning device shall have a timer which complies with the requirements of 21 CFR Part 1040.20. The maximum timer interval shall not exceed the manufacturer’s maximum recommended exposure time by a factor greater than ± 10 percent of the indicated setting.
	  b.   	 Each tanning device must have a method of remote timing located so that consumers may not control their own exposure time.
	  c.   	 Tokens for token timers shall not be issued to any consumer in quantities greater than the device manufacturer’s maximum recommended exposure time for the consumer.
	 46.5(4) Each tanning device shall incorporate a control on the product to enable the consumer to manually terminate the radiation emission from the product at any time without disconnecting the electrical source or removing the ultraviolet lamp.
	 46.5(5) The operator shall ensure that the facility’s interior temperature does not exceed 100 degrees F or 38 degrees C.
	 46.5(6) Condition of tanning devices.
	  a.   	 There shall be physical barriers to protect consumers from injury induced by falling against or breaking the lamps.
	  b.   	 The tanning devices shall be maintained in good repair and comply with all state and local electrical code requirements.
	 46.5(7) Additional requirements for stand-up booths.
	  a.   	 There shall be physical barriers (e.g., handrails) or other means (floor markings) to indicate the proper exposure distance between ultraviolet lamps and the consumer’s skin.
	  b.   	 The construction of the booth shall be such that it will withstand the stress of use and the impact of a falling person.
	  c.   	 Access to the booth shall be of rigid construction; doors shall open outwardly. Handrails and nonslip floors shall be provided.
	 46.5(8) Protective eyewear.
	  a.   	 Eyewear shall not be reused by another consumer.
	  b.   	 Protective eyewear shall meet the requirements of 21 CFR Part 1040.20(c)(4).
	  c.   	 Protective eyewear shall not be altered in any manner that would change its use as intended by the manufacturer (e.g., removal of straps).
	  d.   	 A tanning facility operator shall not allow a consumer to use a tanning device if that consumer does not use the protective eyewear required by this subrule. To verify that a consumer has the proper eyewear, the operator must:
	 (1) 	 Ask to see the eyewear before the consumer enters the tanning room; or
	 (2) 	 Provide disposable eyewear in the tanning room at all times and post a sign stating that the disposable eyewear is available and that eyewear must be worn.
	  e.   	 A tanning facility operator shall instruct the consumer in the proper utilization of the protective eyewear required by this subrule.
	 46.5(9) Operation.
	  a.   	 A trained operator must be present when a tanning device is operated. The operator must be within hearing distance to allow the consumer to easily summon help if necessary. If the operator is not in the immediate vicinity during use, the following conditions must be met:
	 (1) 	 The consumer can summon help through use of an audible device such as an intercom or buzzer; and
	 (2) 	 The operator or emergency personnel can reach the consumer within a reasonable amount of time after being summoned.
	  b.   	 The facility permit to operate shall be displayed in an open public area of the tanning facility.
	  c.   	 A record shall be kept by the facility operator of each consumer’s total number of tanning visits and tanning times, exposure lengths in minutes, times and dates of the exposure, and any injuries or illness resulting from the use of a tanning device.
	  d.   	 Any tanning injury not requiring a physician’s care and any resulting changes in tanning sessions shall be noted in the consumer’s file. A written report of any tanning injury requiring a physician’s care shall be forwarded by the permit holder to the department within five working days of its occurrence or knowledge thereof. The report shall include:
	 (1) 	 The name of the affected individual;
	 (2) 	 The name and location of the tanning facility involved;
	 (3) 	 The nature of the injury;
	 (4) 	 The name and address of the health care provider treating the affected individual, if any; and
	 (5) 	 Any other information considered relevant to the situation.
	  e.   	 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 device or with lamps or filters that are “equivalent” under 21 CFR Part 1040, Section 1040.20, and policies applicable at the time of lamp manufacture.
	  f.   	 The permit holder shall replace ultraviolet lamps and bulbs, which are not otherwise defective or damaged, at such frequency or after such duration of use as may be recommended by the manufacturer of such lamps or bulbs.
	  g.   	 Contact surfaces of tanning devices shall be:
	 (1) 	 Cleansed by the operator with a cleansing agent between each use;
	 (2) 	 Covered by a nonreusable protective material during each use; or
	 (3) 	 Cleansed by the consumer provided the following conditions are met:
	  1. 	 The operator instructs the consumer annually on how to properly cleanse the unit;
	  2. 	 The consumer annually signs a statement stating that the consumer agrees to cleanse the unit after each use;
	  3. 	 Signs are posted in each tanning room reminding the consumer to cleanse the tanning unit after each use and stating the proper way to cleanse the unit; and
	  4. 	 The operator cleanses the tanning unit at least once a day.
	  h.   	 Any records or documentation required by this chapter must be maintained in the tanning facility for a minimum of two years. Records maintained on computer systems shall be regularly copied, at least monthly, and updated on storage media other than the hard drive of the computer. An electronic record must be retrievable as a printed copy.
	  i.   	 The operator shall limit the exposure of the consumer to the maximum exposure frequency and session duration recommended by the manufacturer.
	  j.   	 When a tanning device is being used, no other person shall be allowed to remain in the tanning device area.
	  k.   	 No person or facility shall advertise or promote tanning packages labeled as “unlimited” unless tanning frequency limits set by the manufacturer are included in advertisements.
	 46.5(10) Training of operators.
	  a.   	 No individual shall begin functioning as an operator unless the individual has satisfactorily completed a training program. Training shall include but not be limited to:
	 (1) 	 The requirements of this chapter;
	 (2) 	 Procedures for correct operation of the tanning facility and tanning devices;
	 (3) 	 The determination of skin type of consumers and appropriate determination of duration of exposure to tanning devices;
	 (4) 	 Recognition of reaction or overexposure;
	 (5) 	 Manufacturer’s procedures for operation and maintenance of tanning devices;
	  b.   	 Owners and managers must complete formal training approved by the department. All owners and managers trained after December 31, 1997, must satisfactorily pass a certification examination approved by the department before operating a tanning facility or training employees.
	  c.   	 For operators trained after December 31, 1997. Owners and managers are responsible to train operators in the above topics and to provide review as necessary. Training programs shall be approved by the department and include final testing. Operators shall be questioned during inspections as to the level of their understanding and competency in operating the tanning device.
	  d.   	 Proof of training for both owner/managers and employees must be maintained in the tanning facility and available for inspection. For operators trained after December 31, 1997, the employee record shall be the original test which bears the signature of the employee, the date, and a statement signifying that all answers have been completed by the employee and without prior knowledge of the scoring key.
	  e.   	 Operators shall be at least 16 years of age.
	  f.   	 Operators shall complete the required training and testing every five years.
	 46.5(11) Promotional materials. A tanning facility shall not claim, or distribute promotional materials that claim, that using a tanning device is safe or free from risk or that the use of the device will result in medical or health benefits. The only claim that may be made is that the device is for cosmetic use only.
	 46.5(12) Requirements for electronically controlled facilities. Electronically controlled facilities are those facilities that rely on electronic means to monitor consumers.
	  a.   	 Entry into the facility is allowed by card only. Two individuals may not enter under the same card. The card is specifically activated for tanning use if the facility offers other activities.
	  b.   	 Police and all emergency services will have access to the facility through a key box located outside the entrance of the facility.
	  c.   	 The tanning unit will not activate if the card is not programmed for tanning. The card will not activate if two individuals are in the tanning room.
	  d.   	 The consumer must sign a tanning agreement that states the number of minutes per session, that the consumer agrees to wear protective eyewear, that the consumer will cleanse the unit after tanning, and that the consumer is aware of the emergency access in each room.
	  e.   	 The card will be programmed for the number of minutes the consumer is allowed to tan. The card may be reprogrammed for an increase in minutes per session only after the consumer has reviewed and re-signed the Tanning Agreement. After 30 consecutive days without the consumer’s accessing the tanning facility, the card will be deactivated and the consumer must reapply to access the tanning unit.
	  f.   	 The operator will demonstrate to each consumer how to properly cleanse the unit after tanning, including the top, bottom, and handles. A sign will be placed in each room explaining the cleansing process. The operator will cleanse the units at least once a day when they are in use.
	  g.   	 Free disposable eyewear will be placed in each room along with a sign stating that the disposable eyewear is available and that eyewear must be worn.
	  h.   	 An emergency call button or device will be placed in each tanning room conveniently located within reach of the tanning bed. This device will call the operator or emergency personnel.
	  i.   	 During annual inspections, the inspector may ask any consumer about any of the above processes.