Jim ShepherdJim Shepherd President/co-owner KBD,INC. President/co-owner KBD,INC.

manufacturer of Sperti ultraviolet manufacturer of Sperti ultraviolet products.products.

One of two U.S. representatives to IEC One of two U.S. representatives to IEC Technical Committee 61, Maintenance Technical Committee 61, Maintenance Team 16, for IEC 60335-2-27 “IEC UV-Team 16, for IEC 60335-2-27 “IEC UV-tanning standard”tanning standard”

Indoor Tanning Association, Board Indoor Tanning Association, Board Member, Scientific Committee Chair.Member, Scientific Committee Chair.

President, UV Foundation, a non profit President, UV Foundation, a non profit organization.organization.

The UV FoundationThe UV FoundationThe UV Foundation funds research projects that will The UV Foundation funds research projects that will

lead to a better understanding of the full scope of the lead to a better understanding of the full scope of the

biologic effects of ultraviolet light. Research into biologic effects of ultraviolet light. Research into

areas such as vitamin D production and areas such as vitamin D production and positive positive

effects of ultraviolet lighteffects of ultraviolet light exposure are vastly under- exposure are vastly under-

funded and little understood. The UV Foundation also funded and little understood. The UV Foundation also

engages in efforts to increase public awareness about engages in efforts to increase public awareness about

the affects of UV light. We hope that these efforts the affects of UV light. We hope that these efforts

will lead to better public understanding of the will lead to better public understanding of the

calculus between benefits and risks of UV lightcalculus between benefits and risks of UV light and and

will create a synergistic effect in the research will create a synergistic effect in the research

community, fostering the impetus to conduct more community, fostering the impetus to conduct more

research. research.

MALIGNANT MELANOMA: Scatter Diagram--After Urbach

YEAR

1930 1940 1950 1960 1970 1980 1990 2000

AN

NU

AL

INC

IDE

NC

E(A

ge

Ad

just

ed P

er 1

00,0

00)

1

10

100

USA Ontario Rochester Denmark Norway Finland r2 = 0.91 Australia

r2 = 0.999

Sunlamp Timer Dose Sunlamp Timer Dose EquivalenceEquivalence

FDA Te (min)10 20 30 40 50 60

Eq

uiv

alen

t E

xpo

sure

(C

IE S

ED

per

FD

A T

e)

4.0

4.5

5.0

5.5

6.0

6.5

7.0

7.5

8.02004 IEC Timer Max (8 SED)

Current US Timer Max (Te) From 1986 CDRH Guidancemean (4.54) ±2 SD (0.17), n=76

2009 IEC Timer Max (6 SED)2003 CDRH Proposed

FDA -vs- IEC FDA -vs- IEC Sunlamp Regulatory TimelineSunlamp Regulatory Timeline

This begs the question: Who should “Harmonize” with whom?

1985 & 1986Performance Std& Guidance forTimer as Erythemal Dose& Exposure schedule

1999 ANPRUpdate Std

CDRH ProposedRevised Timer

600 J / m²

2004 IEC Defines Timer In terms of Erythemal Dose

for the FIRST TIMEas 800 J / m²

2009 IEC Reduces Timerto 600 J / m²

and FIRST Describes Exposure Schedule

1985 & 1986Performance Std& Guidance forTimer as Erythemal Dose& Exposure schedule

1999 ANPRUpdate Std

CDRH ProposedRevised Timer

600 J / m²

2004 IEC Defines Timer In terms of Erythemal Dose

for the FIRST TIMEas 800 J / m²

2009 IEC Reduces Timerto 600 J / m²

and FIRST Describes Exposure Schedule