333-119-0100 Specific Requirements: Equipment (1) The registrant shall use only tanning devices manufactured in accordance with the specifications set forth in 21 CFR Part 1040, Section 1040.20, "Sunlamp Products and Ultraviolet Lamps Intended for Use in Sunlamp Products." (2) Each tanning device shall be labeled in accordance with 21 CFR Part 1040. (3) Adequate means shall be provided to enable a customer to summon assistance from the exposure position. (4) All persons hired for servicing and repair of tanning devices shall be State of Oregon licensed electricians. (5) State of Oregon electrical codes must be observed during service and repair actions. (6) Replacement lamps shall be certified by the manufacturer as equivalent to the original lamp type as specified by the manufacturer, or certified as an equivalent lamp per 21 CFR 1040.20. (7) If equivalent lamps are used instead of the Original Equipment Manufacturer (OEM) required lamps, a copy of the equivalency certification, provided by the lamp supplier, shall be maintained for review by the Authority during inspections. (8) Lamps removed from a tanning device shall be disposed of in a safe and proper manner to prevent unauthorized and unsafe use as lighting devices. Used tanning lamps are prohibited from being resold for any purpose. (9) If the ultraviolet tanning device is not in an individual cubicle, then a suitable screen, curtain, or other shield shall be provided, maintained, and used to prevent unnecessary exposure to ultraviolet radiation of persons not using the device. (10) Each tanning device shall have a timer that complies with the requirements of 21 CFR Part 1040, Section 1040.20 (c)(2). (11) The maximum timer interval shall not exceed the manufacturer's maximum recommended exposure time, or 20 minutes, whichever is less. (12) A tanning facility shall use the following exposure schedule for tanning devices originally designed with a 30 minute maximum exposure time that have been reduced to a 20 minute maximum exposure time. A copy of this exposure schedule must be affixed to the tanning device, and a copy maintained at the timer controls. (a) Skin type 1: (A) Week 1: 1–3 minutes; (B) Week 2: 4–6 minutes; (C) Week 3: 7–10 minutes; (D) Week 4: 11–15 minutes. (b) Skin type 2 and 3: (A) Week 1: 4 minutes; (B) Week 2: 8 minutes; (C) Week 3: 12 minutes; (D) Week 4: 16 minutes; (E) Weekly maintenance: 20 minutes. (c) Skin Type 4 and 5: (A) Week 1: 4 minutes; (B) Week 2: 12 minutes; (C) Week 3: 16 minutes; (D) Week 4: 20 minutes; (E) Weekly maintenance: 20 minutes. (13) Tanning device timers shall be controlled by a trained operator. A remote timer control system shall be used for this purpose. (14) Each tanning device shall be equipped with a functional emergency shut-off mechanism to allow manual termination of the UV exposure by the customer, as required by 21 CFR 1040.20(c)(3). (15) Each timer must be functional and accurate to within ± 10 percent. (16) The registrant shall ensure that the timer is checked annually for accuracy and the results recorded. (17) The registrant shall ensure that the emergency shut-off is tested annually for proper function and results recorded. (18) All tanning devices shall be maintained to the minimum requirements of the manufacturer. Statutory/Other Authority: ORS 431.925 - 431.955 Statutes/Other Implemented: ORS 431.655, 431.930 & 431.945 History: PH 32-2014, f. 12-22-14, cert. ef. 1-1-15 PH 10-2011, f. 9-30-11, cert. ef. 10-1-11 PH 4-2010, f. & cert. ef. 2-16-10 PH 14-2008, f. & cert. ef. 9-15-08 PH 36-2004, f. & cert. ef. 12-1-04 PH 31-2004(Temp), f. & cert. ef. 10-8-04 thru 4-5-05 PH 3-2003, f. & cert. ef. 3-27-03 HD 15-1994, f. & cert. ef. 5-6-94 HD 15-1991, f. & cert. ef. 10-1-91