Policy On Maximum Timer Interval and Exposure Schedule For Sunlamp Products

Administrative guidance, not enacted legislation. This captured publisher edition preserves the listed document and attachments; later developments are not independently consolidated.

DEPARTMENT OF HEALTH & H U M A N SERVICES 	Public Health Service
= .
Food and Drug Adrnmistrat~on
#16 	2 1 (ge6 	8 7 5 7 Georgia Avenue
Sdver Sprmg MD 209 10
TO: 	A L L MANUFACTURERS, 	I M P O R T E R S AND P O T E N T I A L MANUFACTURERS O F
SUNLAMP PRODUCTS.
S U B J E C T : 	P O L I C Y ON MAXIMUM T I M E R I N T E R V A L AND EXPOSURE SCHEDULE F O R
SUNLAMP PRODUCTS.
BACKGROUND:
The amended performance s t a n d a r d f o r sunlamp products ( 2 1 CFR 1040.29) 	was
published i n t h e September 6, 	1985 i s s u e of 	t h e Federal R e g i s t e r and w i l l
become e f f e c t i v e September 8 , 	1986. 	Any sunlamp product manufactured on o r
a f t e r t h a t d a t e must comply with t h e amended standard.
The t e n (10) minute maximum timer 	i n t e r v a l requirement was removed
from t h e o r i g i n a l performance s t a n d a r d s i n c e t h e r e a r e newer sunlamp
products 	on t h e market 	f o r which t e n (10) minutes is not a p p r o p r i a t e .
The maximum timer i n t e r v a l now depends on t h e 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)r a d i a t i o n emission of each i n d i v i d u a l
model of 	sunlamp product and must not exceed t h e maximum recommended
exposure time provided on t h e r e q u i r e d product warning l a b e l . 	T h e r e f o r e ,
sunlamp product manufacturers must develop a n exposure schedule and
e s t a b l i s h t h e maximum recommended exposure tlme (and 	t h e r e f o r e t h e
maximum t i m e r i n t e r v a l ) 	based on t h e c h a r a c t e r i s t i c s o f t h e i r p a r t i c u l a r
products.
The intended purposes of 	a sunlamp product 	t i m e r a r e t o provide
f o r r e l i a b l e c o n t r o l of exposures and t o l i m i t a c u t e (and delayed) damage
from u n i n t e n t i o n a l l y long exposures. 	However, 	t h e maximum timer s e t t i n g ;
should a l s o a l l o w f o r s e l e c t i o n o f exposure times needed t o b u i l d up and
maintain a tan. 	The maxlmurn t i m e r i n t e r v a l i s 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 r a d i a t i o n is p o t e n t i a l l y hazardous.
The s t a n d a r d r e q u i r e s t h e manufacturer t o provide a n exposure schedule
i n t h e product warning l a b e l . 	The purpose o f 	t h e 	exposure schedule
is t o a l l o w a person t o g r a d u a l l y build-up 	s k i n pigmentation and t o
m a i n t a i n a t a n while c o n t r o l l i n g t h e r i s k of a c u t e i n j u r y and delayed
a d v e r s e e f f e c t s . 	Since t h e W 	r a d i a t i o n dose t h a t causes a b a r e l y
d i s c e r n i b l e pink c o l o r a t i o n (minimal erythema1 dose o r MED) 	is not 	t h e same
f o r d i f f e r e n t s k i n t y p e s , 	t h e exposure schedule f o r f i r s t time u s e r s w i l l
depend on t h e s k i n t y p e of 	t h e user. 	Furthermore, 	suberythemogenic doses
of W 	r a d i a t i o n received 	at 24 hours i n t e r v a l s i n i t i a l l y l e a d t o lowering;
of 	t h e erythema and t a n n i n g t h r e s h o l d s . 	Therefore, 	t h e exposure schedule
and maximum recommended exposure t i m e should be c o n s t r a i n e d by t h e
p o t e n t i a l f o r erythema a s w e l l as t h e q u a n t i t y of 	r a d i a t i o n necessary t o
a c h i e v e and maintain a tan.
POLICY :
The Center f o r Devices and R a d i o l o g i c a l Health (CDRH) w i l l u s e t h e
f o l l o w i n g c r i t e r i a t o e v a l u a t e t h e adequacy of 	t h e exposure schedule and
t h e recommended maximum exposure t i m e (and t h e r e f o r e t h e maximum timer
i n t e r v a l ) :

Page 2
1) 	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
2Te = 6 2 4 5 1 ~ ~ where Standard MED = 1565lM 	at 296nm
CViRi vi = weighting factor
Ri = irradiance in W/M2
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 :
2
where standard MMD = 4 5 9 J / M 	at 296nm
J~ = weighting factor
tRi = irradiance in W/M2
3) 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,lyfour 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 	( n m )
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
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.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 	(~arrishet 	a1 	1982)

Appendix B
(page 2)
TYPE I1 	S K I N 	1982