Policy On Maximum Timer Interval and Exposure Schedule For Sunlamp Products
Published: 1985-08-21
Status: Final Type: Guidance Document Category: Radiation / Imaging Topics: Tanning Lamps, Booths & Beds Docket: FDA-2020-D-0957
Official Source
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/policy-maximum-timer-interval-and-exposure-schedule-sunlamp-products PDF: https://www.fda.gov/media/77779/download
Official Full Text
DEPARTMENT OF HEALTH & H U M A N SERVICES Public Health Service = . Food and Drug Adrnmistrat~on #16 2 1 (ge6 8757 Georgia Avenue Sdver Sprmg MD 209 10 TO: ALL MANUFACTURERS, IMPORTERS AND POTENTIAL MANUFACTURERS O F SUNLAMP PRODUCTS. SUBJECT: POLICY ON MAXIMUM TIMER INTERVAL AND EXPOSURE SCHEDULE FOR SUNLAMP PRODUCTS. BACKGROUND: The amended performance standard for sunlamp products (21 CFR 1040.29) was published i n the September 6, 1985 issue of the Federal Register and w i l l become effective September 8, 1986. Any sunlamp product manufactured on o r a f t e r t h a t date must comply with the amended standard. The ten (10) minute maximum timer interval requirement was removed from the o r i g i n a l performance standard since there are newer sunlamp products on the market f o r which ten (10) minutes is not appropriate. The maximum timer i n t e r v a l now depends on the i n t e n s i t y and s p e c t r a l d i s t r i b u t i o n of u l t r a v i o l e t (W) radiation emission of each individual model of sunlamp product and must not exceed the maximum recommended exposure time provided on the required product warning label. Therefore, sunlamp product manufacturers must develop an exposure schedule and e s t a b l i s h the maximum recommended exposure tlme (and therefore the maximum timer i n t e r v a l ) based on the characteristics of t h e i r particular products. The intended purposes of a sunlamp product timer are t o provide f o r r e l i a b l e control of exposures and t o l i m i t acute (and delayed) damage from unintentionally long exposures. However, the maximum timer setting; should a l s o allow f o r s e l e c t i o n of exposure times needed t o build up and maintain a tan. The maxlmurn timer i n t e r v a l is i n no way t o be considered a s a s a f e l i m i t ; a l l u l t r a v i o l e t radiation is potentially hazardous. The standard requires the manufacturer t o provide an exposure schedule i n t h e product warning label. The purpose of the exposure schedule is t o allow a person t o gradually build-up skin pigmentation and t o maintain a tan while controlling the r i s k of acute injury and delayed adverse effects. Since the W radiation dose that causes a barely discernible pink coloration (minimal erythema1 dose o r MED) is not the same f o r d i f f e r e n t skin types, t h e exposure schedule f o r f i r s t time users w i l l depend on t h e s k i n type of t h e user. Furthermore, suberythemogenic doses of W radiation received at 24 hours i n t e r v a l s i n i t i a l l y lead t o lowering; of t h e erythema and tanning thresholds. Therefore, the exposure schedule and maximum recommended exposure t i m e should be constrained by the p o t e n t i a l f o r erythema a s w e l l as the quantity of radiation necessary t o achieve and maintain a tan. POLICY : The Center f o r Devices and Radiological Health (CDRH) w i l l use the following c r i t e r i a t o evaluate the adequacy of the exposure schedule and t h e recommended maximum exposure t i m e (and therefore the maximum timer i n t e r v a l ) :
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- The maximum recommended exposure time (and maximum timer interval) must not exceed a value which will result in an exposure of four (4) times the minimal erythema dose (MED) for untanned Type I1 skin (always burns, then tans slightly). This is based on the CDRH Erythema Action Spectrum [proposed action spectrum of Commission Internationale de L'Eclairage (CIE) modified by CDRHI. See Appendix A for the action spectrum and weighting factors and equations needed to derive it. The formula for determining the recommended maximum exposure . time,"T " in seconds is : e Te = 6 2 4 5 1 ~ ~ where Standard MED = 1565lM at 296nm CViRi vi = weighting factor Ri = irradiance in W/M 2
- The recommended maximum exposure time must not exceed a value which will result in an exposure of four (4) times the minimal melanogenic dose (MMD) for untanned Type I1 skin. This is based on the melanogenic action spectrum developed by Parrish et a1 (1982). See Appendix B for this action spectrum. The formula for " T ~ " in seconds determining the recommended maximum exposure time, is : where standard MMD = 459J/M at 296nm J~ = weighting factor tRi = irradiance in W/M 2
- The recommended exposure schedule should provide for exposures of no more than 0.75 MED three times the first week, gradually increasing the exposure the following weeks until maximum tanning has occurred (approximate,ly four weeks total) and then provide for maintenance of a tan by biweekly or weekly exposures of up to four(4) MEDs or four(4) MMDs, whichever is less. CDRB believes that the above criteria balances the need to limit acute (and delayed) damages from unintentionally long exposure and the need to provide for single exposure durations adequate to achieve and maintain a tan. Walter E. Gundaker, Director Office of Compliance Center for De&es and Radiological Health Appendices
Appendix A (page 1) L n W E I G H T I N G F A C T O R S F O R E R Y T H E M A , V f W a v e l e n g t h (nm) t The equations . . . . describing the curve are:
Appendix A [DATA]GIELYTLE ERYTHEMA. Vi CIE ACTION SPECTRUM MODIFIED BY LYTLE (CDRH) NORMALIZED TO 1 AT READING 1 1 1 I 1 1 1 I 1 1 I I I 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 .7691 5916 .4U
- WAVELENGTH (nm) The MMD as function of wavelength has bean interpolated (using log MMD) fromrthe action spectrum tor melanogenesis of type 11 skin (~arrish et a1 1982)
Appendix B (page 2) TYPE I1 S K I N 1982