# Presentation: 400528

## TEPRSSC Meeting PresentationOctober 1, 2003

- _D. L. Smith_
_*U*__*V*__*I*__*R*_* Research Institute*
- [Ultraviolet, Visible and Infrared Radiation]
- Tucson, AZ

## 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.

## A Paradoxical Role Reversal Situation

- FDA recommended adopting the same _less protective_
- 	CIE Erythemal Action Spectrum that was rejected by
- 	Dr. 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 and
- 	his associates that has served us so well since 1985
- 	because doing so _decreases_ the _erythemal risk_ of
- 	the _American public_ who _choose to tan_.

## A Paradoxical Role Reversal Situation

- 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.

## A Paradoxical Role Reversal Situation

- 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.

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

- Companies under the jurisdiction of FDA must provide
- 	_proof 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_.

## 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 adopting
- 	the _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_.

## 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

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

_**FDA EAS is weighted more stongly than the CIE EAS**_

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

_**FDA EAS is weighted more stongly than the CIE EAS**_

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

- _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

## 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
- 	T**e** (time to 4.0 MED) time when you consider
- 	the difference in the 1.0 weighting factor range
- 	and the different J/m^2 threshold levels is:
- 	-	_1.0 __(FDA EAS)__ to 1.5 __(CIE EAS)_

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

-    **We found that the **_**ratio between them changes as the UVB/UVA2 percentage increases**_

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

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

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

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

## 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_.

## 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
- 	T**e** (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.

## 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_

## 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!

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

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

## 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_ _irradiance_
- 	to:
- 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_ T**e** (time to 4.0 MED) time (_17 – 30 minute T__**e**__ time range_)
- 	absolute erythemal weighted irradiance.

##  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.**** **

##  The Y Axis Recommendation Is A Political Recommendation

_**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.**

## The Y Axis Recommendation Is A Political Recommendation

## The Y Axis Recommendation Is A Political Recommendation

## The Y Axis Recommendation Is A Political Recommendation

## The Y Axis Recommendation Is A Political Recommendation

## The Y Axis Recommendation Is A Political Recommendation

## The Y Axis Recommendation Is A Political Recommendation

## The Y Axis Recommendation Is A Political Recommendation

- 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.”**_

## The Y Axis Recommendation Is A Political Recommendation

_**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 owners**
**	****to **_**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**_**.**

## 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.**

## 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.**

## 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 a
- 		fair and equitable regulation that _depends_
- 		upon the _measurement of performance_.
- Thus, _we need__ __a standard protocol_ for testing an
- 	array of sunlamps, i.e., a sunbed, _before_ adopting
- 	the “_Definition of a Manufacturer_” Amendment.

## 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.

## Eyewear Tests – 10 Leading Products

## Eyewear Tests – 10 Leading Products

## 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:**** **
**	**-**	****D**_**o 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**_**. ****	**

## Closing Request Of TEPRSSC

_**Reject**_** FDA’s Request To:**
- 	-	_**Change**_** from **_**more protective**_** FDA EAS**
**	****	****to 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.**
- 	-	M**ake **_**protecting**_** the **_**American public**_**, ****not**** **
**	****	**_**global harmonization**_**, ****their**** **_**first priority**_**!**

## AMERICA FIRST!

## TEPRSSC Presentation

_**Irradiance Caps**_
_**IEC APPLIANCE TYPES**_
_**Type**_**	**_**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

## TEPRSSC Presentation

_**Irradiance Caps**_
_**Type 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****	**

##     The Y Axis Recommendation Is A Political Recommendation

_**Non-Melanoma Skin Cancer Action Spectrum**_ **Is An Attempt To:**
-  		**1.   **_**M**__**ake**_** a **_**political statement**_** that ignores the scientific facts.**
**	****	****2.   **_**A**__**dopt**_** **_**unwarranted and unnecessary**_** annual UVR dose limits.**
**	****	****3.   **_**D**__**amage**_** the USA indoor tanning industry **_**financially**_**.**
**	****	****4.   **_**E**_**nact a “de facto” **_**ban**_** of the indoor tanning industry.**
**	****That will:**
**	****	****5.  **_**U**__**nintentionally**_** **_**damage the American public**_**. **
**	****	****6.  **_**P**__**ut**_** other ****“**_**sunshine dependant**_**”**** industries in **_**jeopardy**_**.**

## 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_

## 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		180
- mJ/cm^2		21.0		15.6		20.0		18.0
- J/cm^2		0.021		0.0156		0.02		0.018
- microwatts/m^2	58,300		43,300		55,600		50,000
_**mW/m^2**__**	**__**	**__**58.3**__**	**__**	**__**43.3**__**	**__**	**__**55.6**__**	**__**	**__**50.0**__	_
- microwatts/cm^2	5.83		4.33		5.56		5.00
- W/m^2		0.0583		0.0433		0.0556		0.05
- mW/cm^2		0.00583		0.0043		0.00556		0.005
- W/cm^2		0.00000583	0.00000433	0.00000556	0.000005