1 teprssc meeting presentation october 1, 2003 d. l. smith uvir research institute [ultraviolet,...

1

TEPRSSC Meeting PresentationOctober 1, 2003

D. L. SmithUVIR Research Institute

[Ultraviolet, Visible and Infrared Radiation]

Tucson, AZ

2

The Indoor Tanning Industry….

Has An Enviable FDA Complaint History

My Freedom Of Information Act request showed:

1. 84 valid complaints over a 15 year (1985-2000) period.2. Which means approximately 1 complaint to FDA for

every 100 million tanning sessions during this period.

An enviable FDA complaint history by any standard!

Much of the credit for this enviable complaint history must be given FDA’s Dr. David Lytle and his colleagues for having the courage and the foresight to develop a more protective erythemal action spectrum, the FDA EAS, rather than adopt the less protective CIE EAS in 1985.

3

A Paradoxical Role Reversal Situation

FDA recommended adopting the same less protective CIE Erythemal Action Spectrum that was rejected byDr. Lytle and his associates in 1985, a recommendation that will increase the erythemal risk of the American public who, of their own free will, choose to tan.

I recommend staying with the more protective FDA Erythemal Action Spectrum developed by Dr. Lytle andhis associates that has served us so well since 1985because doing so decreases the erythemal risk of the American public who choose to tan.

4


In addition, FDA wants to adopt the totally unproven and VERY difficult (if not impossible!) to understand “X/Y Ratio” system for labeling sunlamps.

I recommend improving the most protective system in the world – the FDA EAS system - by adding the easy to understand “Bin” system for labeling sunlamps.

5


Paradoxically and counter intuitively, FDA has recommended changing to the less protective CIE erythemal action spectrum while I am recommending staying with the most protective erythemal action spectrum in the world – FDA’s own!

Paradoxically and counter intuitively, FDA has recommended the adoption of an unproven and difficult to understand X/Y Ratio sunlamp labeling scheme while I recommend that we adopt the intuitive and easy to understand and implement “Bin” system.

At stake in this dispute between politics and science is the safety of the American public who choose, of their own free will, to tan at a professional indoor tanning salon.

6

What’s Sauce For The Goose Is Sauce For The Gander

Companies under the jurisdiction of FDA must provideproof of efficacy before they are allowed to proceed.

Therefore, FDA must be held to the same, or higher, standards of proof before being allowed to make changes to the standards governing the indoor tanning industry.

TEPRSSC has the responsibility of making sure that FDA provides adequate proof to support proposed changes that may adversely affect the health and well-being of the American public much like the NASA Safety Committee has the responsibility of making sure that NASA protects the safety of our Astronauts.

7

What’s Sauce For The Goose Is Sauce For The Gander

FDA provided inadequate proof to support changing from the more protective FDA EAS to the less protective CIE EAS.

FDA has not conducted adequate studies to support adopting the Non-Melanoma Skin Cancer Action Spectrum.

FDA has not considered the needless confusion that adoptingthe X/Y coding scheme for labeling sunlamps will cause.

FDA ignored the negative response that the X/Y system received when it was discussed in February, 2001.

Instead, FDA requests that these draconian changes be adopted in order to achieve the political goal of Global Harmonization.

8

Why Is The FDA EAS More Protective Than The CIE EAS?

Broader 1.0 Weighting Factor Used By FDA EAS

- 280 – 298 nm (CIE) vs 280 – 302 nm (FDA)

- CIE EAS is 28% less protective than FDA EAS

9


FDA EAS is weighted more stongly than the CIE EAS

Erythemal Action Spectrum Comparison

[FDA EAS vs CIE EAS]

0.00

0.10

0.20

0.30

0.40

0.50

0.60

0.70

0.80

0.90

1.00

250 260 270 280 290 300 310 320 330 340 350 360 370 380 390 400

We

igh

tin

g F

ac

tor

Wavelength (nm)

FDA CIE

10


FDA EAS is weighted more stongly than the CIE EAS

Erythemal Action Spectrum Comparison

[FDA EAS vs CIE EAS]

0.00

0.10

0.20

0.30

0.40

0.50

0.60

0.70

0.80

0.90

1.00

280 281 282 283 284 285 286 287 288 289 290 291 292 293 294 295 296 297 298 299 300 301 302 303 304 305 306 307 308 309 310 311 312 313 314 315 316 317 318 319 320

We

igh

tin

g F

ac

tor

Wavelength (nm)

FDA CIE

11


More Conservative J/m^2 Threshold Per MED

- 200 J/m^2/MED (CIE) vs 156 J/m^2/MED (FDA)

- CIE EAS is 22% less protective than FDA EAS

12

Why The FDA EAS Is More Protective Than The CIE EAS

Thus, the theoretical difference between the FDA EAS and the CIE EAS with regards to the Te (time to 4.0 MED) time when you considerthe difference in the 1.0 weighting factor rangeand the different J/m^2 threshold levels is:

- 1.0 (FDA EAS) to 1.5 (CIE EAS)

13


• We found that the ratio between them changes as the UVB/UVA2 percentage increases

Ratio - Te (FDA) vs Te (CIE)

[Time To 4.0 MED][MAD=800 J/m^2]

0.0

0.5

1.0

1.5

2.0

1.5 1.51

1.66

1.86

2.0

1.5 1.51

1.66

1.86

2.0

Theoretical 0.15% UVB - LP 1.0% UVB HID/hp 3.5% UVB - LP 8.7% UVB - LP

Ra

tio

: 1

= F

DA

/ V

alu

e S

ho

wn

=C

IE

Solar Simulator Type

Ratio-FDA:CIE Ratio-FDA:CIE

14


And changing the MAD from 800 to 600 J/m^2 doesn’t solve the problem

Ratio - Te (FDA) vs Te (CIE)

[Time to 3.0 MED][MAD=600 J/m^2]

0.0

0.2

0.4

0.6

0.8

1.0

1.2

1.4

1.6

1.8

1.18 1.19

1.34

1.54

1.7

1.18 1.19

1.34

1.54

1.7


Ra

tio

: 1

=F

DA

/ V

alu

e S

ho

wn

=C

IE


Ratio-FDA:CIE Ratio-FDA:CIE

15


Adopting CIE AS Increases The Risk To American Public Who Choose To Tan

Comparison - FDA AS vs CIE AS

[FDA=4.0; CIE=600; CIE vs 800]

0

10

20

30

40

20 20 20 20

10

23.6 23.8

26.8

30.8

17.0

30 30.2

33.2

37.2

20


Min

ute

s


FDA-624 CIE-600 CIE-800

16

Why FDA’s Proposed X/Y Labeling System Is A Step Backward

X Axis Label = Weighted total irradiance value using CIE EAS - In mW/cm^2 ???? = 100.0 mW/cm^2 ????

Y Axis Label = Ratio of 250-320 nm to 320-400 nm using the Non-Melanoma Skin Cancer Action Spectrum- 0.3 W/m^2 : 0.3 W/m^2 = 1.0 Ratio ????

X/Y Ratio = 100.0 mW/cm^2 : 1.0 Ratio = 1% Skin Cancer Power ????

XY Values derived from testing a single lamp in a test stand

- No provision for measuring an array of sunlamps.

17

Why FDA’s Proposed X/Y Labeling System Is A Step Backward

Weighted total irradiance value (X axis) is not as useful as the current Te (time to 4.0 MED) time calculation because relying on total irradiance “masks” the differences caused by the UVB/UVA2 lack of linearity problem.

Using the weighted NMSC AS ratio (Y axis) is totally unproven!

Values obtained by testing a single lamp in a test stand, under controlled conditions, are useful for determining sunlamp compatibility but they are not adequate for calculating exposure schedules. For that, the complete array of sunlamps, i.e., the sunbed must be tested under standard conditions. Thus, the proposed FDA X/Y sunlamp labeling system only addresses the easy half of the problem.

FDA’s labeling scheme will result in a massive amount of confusion which will adversely affect the indoor tanning industry, the regulatory community and the American public who chooses to tan.

18

The Ideal Sunlamp Labeling System

Must Be Easy To Understand By All Segments Of Industry.- Tanning salon owners- Vendors- Regulators- Clients

Must Be Logical And Intuitive.

Must Be Easy And Inexpensive To Implement.

Must Be Able To Resolve Two “Festering” Problems.- Determining sunlamp compatibility- Determining exposure schedules

19

Easy To Understand and Logical And Intuitive

The indoor tanning industry classifies, and talks about, their sunbeds according to their MTI (Maximum Timer Interval). Thus, we have:

- 30 minute (MTI) sunbeds

- 20 minute (MTI) sunbeds- 15 minute (MTI) sunbeds- 12 minute (MTI) sunbeds- 10 minute (MTI) sunbeds- 8 minute (MTI) sunbeds- 6 minute (MTI) sunbeds

The “ideal system for labeling sunlamps” must, therefore, recognize and accept this important “real world” fact of life!

20

Only The Bin System Meets ALL OF The “Ideal Sunlamp Labeling System” Requirements

UVIR Sunlamp Labeling Concept

[Low = 85% of Te / High = 150% of Te]

0

10

20

30

40

50

45

30

22

18

15

12

9

30

20

15

1210

86

25.5

17

12.8

10.28.5

6.85.1

Bin 30 Bin 20 Bin 15 Bin 12 Bin 10 Bin 8 Bin 6

Te

(T

ime

-4.0

ME

D)

Tim

e (

Min

ute

s)

Bin Classification

High Bin 20 Low

21

Only The Bin System Meets ALL OF The “Ideal Sunlamp Labeling System” Requirements

20 Minute Sunbed (Bin 20) Range

[Low = 85% / High = 150%]

0

5

10

15

20

25

3030

20

17

High Bin 20 Low

Te

(T

ime

To

4.0

ME

D)

Tim

e (

Min

ute

s)

Bin 20 Range

Te Time

22

Compare The Simplicity Of The Bin System To The Complexity of X/Y System

Proposed X/Y Ratio System:

X = 100.0 mW/cm^2 of absolute erythemal weighted irradianceto:

Y = 1.0 ratio (250-320 vs 320-400) of skin cancer power ?????

X/Y Ratio = 100.0:1.0 ratio = 1% skin cancer power ?????

Proposed Bin System:

20 minute Te (time to 4.0 MED) time (17 – 30 minute Te time range)absolute erythemal weighted irradiance.

23

The Y Axis Recommendation Is A Political Recommendation

Non-Melanoma Skin Cancer Action Spectrum

Is An Action Spectrum For:

1. Squamous Cell Carcinoma.

2. In albino mice.

3. That were irradiated with sunlamps containing

UVC and abnormally high levels of UVB.

24


Non-Melanoma Skin Cancer Action Spectrum

Is Not An Action Spectrum For:

1. Evaluating the spectral characteristics of the sunlamps

used by the USA indoor tanning industry.

2. Estimating the “dose response” human risk of developing squamous cell carcinoma.

3. Labeling sunlamps for commercial purposes.

25


NMSC AS vs FDA Erythemal AS

[250 nm - 400 nm]

0.0

0.1

0.2

0.3

0.4

0.5

0.6

0.7

0.8

0.9

1.0

250 260 270 280 290 300 310 320 330 340 350 360 370 380 390 400

We

igh

tin

g F

ac

tor

Wavelength (nm)

NMSC-AS FDA-EAS

26


NMSC AS vs FDA Erythemal AS

[250 nm - 400 nm]

0.000000

0.100000

0.200000

0.300000

0.400000

0.500000

0.600000

0.700000

0.800000

0.900000

1.000000

280 290 300 310 320

We

igh

tin

g F

ac

tor

Wavelength (nm)

NMSC-AS FDA-EAS

27


NMSC vs FDA vs CIE vs MMD AS

[280 nm - 320 nm]

0.000000

0.100000

0.200000

0.300000

0.400000

0.500000

0.600000

0.700000

0.800000

0.900000

1.000000

280 290 300 310 320

We

igh

tin

g F

ac

tor

Wavelength (nm)

NMSC AS FDA EASCIE EAS FDA MAS

28


Spectral Comparison - 4 Research Lamps[Spectroradiometer @ 13 cm / 1m]

0.000000

0.000002

0.000004

0.000006

0.000008

0.000010

0.000012

0.000014

0.000016

0.000018

250 255 260 265 270 275 280 285 290 295 300 305 310 315 320 325 330 335 340 345 350 355 360 365 370 375 380 385 390 395 400 405 410

W/c

m^

2

Wavelength (nm)

FS 40-13 cm Q-Sun-13 cm FS 340-13 cm

Xenon-Fil-1 meter Xenon-UnF-1 meter

29


Research Solar Simulators vs Sunlight

0

10

20

30

40

50

60

70

80

90

100

0.42 0 0 0 0

61.03

1.39

7.243.9 3.6

38.54

98.61

92.7696.1 96.4

FS 40 Q-Sun FS 340 Sun Xenon-F

Pe

rce

nt

Irradiance Source

UVC UVB UVA

30


Sun-XenonF-FS40-FS40F vs Tanning Lamps

0

10

20

30

40

50

60

70

80

90

100

03.9

96.1

0 1.7

98.3

03.7

96.3

03.6

96.4

0

46

54

0.42

61.03

38.55

UVC% UVB% UVA%

Pe

rce

nt

UVR Segment

Sunlight (Peak) HID/hp sunlamp LP sunlampXenon/F FS 40 (Kodacel) FS 40

31


What respected photobiologists say about the FS 40 sunlamp:

1. “Fluorescent sunlamps are commonly employed as convenient sources

in photobiology experiments. The ability of Kodacel to filter photobiologically

irrelevant UVC wavelengths has been described. Yet there still remains a major unaddressed issue—the over representation of UVB in the output. The shortest terrestrial solar wavelengths the surface are >295 nm with the 295-320 nm range comprising 4% of the solar UV irradiance. In Kodacel-filtered sunlamps, 47% of

the UV output falls in this range. Consequently, in studies designed to understand

skin photobiology after solar exposure, the use of these sunlamps may result in misleading, or even incorrect, conclusions.”

Brown, et al, Photochemistry and Photobiology, 2000, 72(3): 340-344

“Common Fluorescent Sunlamps are an Inappropriate Substitute for Sunlight.”

32


Summary – Non-Melanoma Skin Cancer Action Spectrum

NMSC-AS is an inappropriate action spectrum- It “devalues” the wavelengths associated with causing NMSC.- Mouse to human skin conversion factor not scientifically valid.- Irradiance source used does not “mimic” sunlight or sunlamps.

NMSC-AS is a political proposal, not a scientific proposal- To get the word “cancer” incorporated into Sunlamp Standards!

- To ultimately adopt unrealistic annual UVR dose limits.

NMSC-AS will financially damage the indoor tanning industry.

NMSC-AS will make it difficult for vendors and salon ownersto find liability insurance coverage at a price they can afford.

NMSC-AS will encourage the American public to avoid needed sensible, moderate and responsible UVR exposure.

NMSC-AS adoption will inevitably cause unintended consequences.

33

Warning Label Comments – FDA Version

WARNING - Ultraviolet radiation may cause:

- injury to the eyes and skin

- skin aging - skin cancer

Read instructions carefully.

Wear protective eyewear provided.

Certain medicines and cosmetics may increase sensitivity to ultraviolet radiation.

34

Warning Label Comments – DLS Version

WARNING - Overexposure to ultraviolet radiation may cause:- injury to the eyes and skin - skin aging - skin cancer

Read instructions carefully.

Wear protective eyewear provided.

Individuals taking a medication or using a cosmetic product that may increase their sensitivity to ultraviolet radiation should check with their physician or pharmacist before tanning.

Individuals with systemic lupus erythematosus, rosacea or who have received medical treatment for a diagnosis of skin cancer should check with their physician before tanning.

35

Definition of a Manufacturer – DLS Response

My response is exactly the same as it was last year.

- If you do not have a “standard protocol” for

measuring performance, you can’t have afair and equitable regulation that depends upon the measurement of performance.

Thus, we need a standard protocol for testing anarray of sunlamps, i.e., a sunbed, before adoptingthe “Definition of a Manufacturer” Amendment.

36

Eyewear Tests – 10 Leading Products

10,000 LUX Lamp = 0.150 MED/hour = 400 minutes to 1.0 MED Weakest Eyewear = 0.013 MED/hour = 4500 minutes to 1.0 MED

All eyewear tested meet or exceeded UVR requirements.

- 0.001% - 200 nm – 320 nm- 0.01% - 320 nm – 400 nm

The problem is in the 400 nm – 550 nm range (5 nm increments).

- 436 – 440 = 26.1%- 541 – 545 = 7.4%- 546 – 550 = 15.7%- All other 5 nm ranges are below 0.8%- Average = 2.27%

Thus, the “mercury peaks” found at 436-440 nm and 540-550 nm in the lamps are the cause of the problem.

37


Sunlamp vs Sunlamp + Eyewear[250 nm - 800 nm] [OLI 754 @25 cm]

0.000000

0.000005

0.000010

0.000015

0.000020

0.000025

0.000030

0.000035

250 260 270 280 290 300 310 320 330 340 350 360 370 380 390 400 410 420 430 440 450 460 470 480 490 500 510 520 530 540 550 560 570 580 590 600 610 620 630 640 650 660 670 680 690 700 710 720 730 740 750 760 770 780 790 800

W/c

m^

2

Wavelength (nm)Lamp Eyewear

38


400 nm - 550 nm - Percent Irradiance[5 nm Increments]

0

5

10

15

20

25

30

0.4 0.35 0.3 0.38 0.46 0.49 0.48

26.1

0.58 0.6 0.61 0.64 0.66 0.7 0.68 0.7 0.71 0.73 0.76 0.7 0.68 0.72 0.7 0.7 0.75 0.75 0.71 0.71

7.35

15.7

0.73

2.27

400-40 406-41 411-41 416-42 421-42 426-43 431-43 436-44 441-44 446-45 451-45 456-46 461-46 466-47 471-47 476-48 481-48 486-49 491-49 496-50 501-50 506-51 511-51 516-52 521-52 526-53 531-53 536-54 541-54 546-55 551-55 Average

Wa

ve

len

gth

Ra

ng

e (

nm

)

Percent

Per Cent

39

Closing Request Of TEPRSSC

Approve FDA’s Request To:

- Adopt the “revised” warning label language.

- Include revised warning label language on sunbeds, sunlamps and in catalogs, brochures, etc.

Instruct FDA to:

- Do more testing of available eyewear products before finalizing protective eyewear requirements.

- Instruct FDA to develop standard protocols for testing

sunlamps and sunbeds before moving forward with Definition of a Manufacturer Amendment because if you can’t measure performance, it can’t be enforced.

40

Closing Request Of TEPRSSC

Reject FDA’s Request To:

- Change from more protective FDA EASto the less protective CIE EAS.

- Adopt the totally unproven and politically motivated X/Y Ratio system.

Instruct FDA To:

- Work with industry to improve the more protective FDA EAS.

- Make protecting the American public, not global harmonization, their first priority!

41

AMERICA FIRST!

42

TEPRSSC Presentation

Irradiance Caps

IEC APPLIANCE TYPESType Effective Irradiance Effective Irradiance Total Irradiance

250 nm – 320 nm 320 nm – 400 nm 250 nm – 400 nm

(W/m^2) (W/m^2) (W/m^2)

1 < 0.0005 > 0.15 < 0.1505

2 0.0005 to 0.15 > 0.15 < 0.1505 – 0.3

3 < 0.15 > 0.15 < 0.3

4 > 0.15 > 0.15 > 0.3

43

TEPRSSC Presentation

Irradiance CapsType 3 Appliance

Effective Irradiance Effective Irradiance Total Irradiance Te Time Te Time 250 nm – 320 nm 320 nm – 400 nm 250 nm – 400 nm FDA CIE (W/m^2) (W/m^2) (W/m^2) (Minutes)

(Minutes)

< 0.15 < 0.15 < 0.3 34 44

< 0.3 < 0.3 < 0.6 17 22

< 0.6 < 0.6 < 1.2 9 11

< 0.75 < 0.75 < 1.5 7 9

< 0.9 < 0.9 < 1.8 6 7

44


Non-Melanoma Skin Cancer Action Spectrum Is An Attempt To:

1. Make a political statement that ignores the scientific facts.

2. Adopt unwarranted and unnecessary annual UVR dose limits.

3. Damage the USA indoor tanning industry financially.

4. Enact a “de facto” ban of the indoor tanning industry.

That will:

5. Unintentionally damage the American public.

6. Put other “sunshine dependant” industries in jeopardy.

45

Calculation Denominator Analysis - MED

A B C D

WMO FORMULA FDA – EXISTING CIE & FDA – PROPOSED UViR-RI PROPOSAL

1. 1 MED = 210 J/m^2 156 J/m^2 200 J/m^2 180 J/m^2

2. And 1 MED = 21 mJ/cm^2 15.6 mJ/cm^2 20 mJ/cm^2 18 mJ/cm^2

3. And 1 MED = (1 Joule = 1 watt/second) 210,000 mJ/m^2 156,000 mJ/m^2 200,000 mJ/m^2 180,000 mJ/m^2

4. Thus, 1 MED = 210,000 mW/sec/m^2 156,000 mW/sec/m^2 200,000 mW/sec/m^2 180,000 mW/sec/m^2

5. Therefore, 1 MED = (3600 seconds/hour) 58.33 mW/hour 43.33 mW/hour 55.56 mW/hour 50.00 mW/hour

6. And 1 MED/hour = 58.33 mW/m^2 43.33 mW/m^2 55.56 mW/m^2 50.00 mW/m^2

46

Conversion Factors

Action Spectra EPA/NWS FDA CIE UVIR-RI

Reference Value 1 MED 1 MED 1 MED 1 MED

J/m^2 210 156 200 180mJ/cm^2 21.0 15.6 20.0 18.0J/cm^2 0.021 0.0156 0.02 0.018

microwatts/m^2 58,300 43,300 55,600 50,000mW/m^2 58.3 43.3 55.6 50.0microwatts/cm^2 5.83 4.33 5.56 5.00W/m^2 0.0583 0.0433 0.0556 0.05mW/cm^2 0.00583 0.0043 0.00556 0.005

W/cm^2 0.00000583 0.00000433 0.00000556 0.000005

1 teprssc meeting presentation october 1, 2003 d. l. smith uvir research institute [ultraviolet,...

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