10A NCAC 15 .1415 EQUIPMENT AND CONSTRUCTION REQUIREMENTS
(a) The registrant shall use only tanning equipment manufactured in accordance with the specifications set forth in 21 Code of Federal Regulations (CFR) Part 1040, Section 1040.20, and with 21 CFR Part 878.4635, which is herein incorporated by reference, including subsequent amendments and editions and may be accessed at http://www.ecfr.gov/cgi-bin/ECFR?page=browse. The standard of compliance shall be the standards in effect at the time of manufacture as shown on the equipment identification label required by 21 CFR Part 1010, Section 1010.3. The registrant shall place an additional label on the bed that states "North Carolina state law prohibits the use of this device by persons under 18 years of age."
(b) Each assembly of tanning equipment shall be designed for use by only one consumer at a time.
(c) Each assembly of tanning equipment shall be equipped with a timer that complies with the requirements of 21 CFR Part 1040, Section 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 exceeding plus or minus 10 percent of the maximum timer interval for the product.
(d) Tanning equipment shall include physical barriers to protect consumers from injury induced by touching or breaking the lamps.
(e) All tanning equipment labeling required in Paragraph (a) of this Rule shall be easily read by the consumer while in the proximity of the tanning bed.
(f) The timer intervals shall be numerically indicated on the face of the timer.
(g) The timer shall not automatically reset and cause radiation emission to resume for a period greater than the unused portion of the timer cycle when emission from the tanning device has been interrupted.
(h) Each assembly of tanning equipment shall be provided with a control on the equipment to enable the consumer to manually terminate radiation emission from the equipment at any time without disconnecting the electrical plug or removing any ultraviolet lamp.
(i) The timer for the tanning devices shall be remotely located outside the room where the tanning equipment is located. The remote timer shall be set by a certified tanning operator.
(j) The registrant shall ensure that timer tests are performed annually on each assembly of tanning equipment and documented in writing for agency review during inspections to ensure the timer is accurate to within 10 percent as specified in Paragraph (c) of this Rule and the consumer is able to terminate the radiation manually in accordance with Paragraph (h) of this Rule.
(k) Medical lamps shall not be used for commercial cosmetic tanning purposes.
History Note: Authority G.S. 104E‑7(a)(7); 104E-9.1;
Eff. June 1, 1989;
Amended Eff. August 1, 2002; June 1, 1993;
Transferred and Recodified from 15A NCAC 11 .1415 Eff. February 1, 2015;
Amended Eff. May 1, 2016;
Pursuant to G.S. 150B-21.3A, rule is necessary without substantive public interest Eff. June 22, 2019.