Proposed Amendments to FDA Sunlamp Product Performance Standard Presentation to TEPRSSC October 1, 2003.

Proposed Amendments to FDA Sunlamp Product Performance

Standard

Presentation to TEPRSSCPresentation to TEPRSSC

October 1, 2003October 1, 2003

Background

1998 – Advanced Notice of Proposed 1998 – Advanced Notice of Proposed RulemakingRulemaking

– Concerns about melanoma being related to Concerns about melanoma being related to sunlamp usesunlamp use

– Reports of melanoma ’epidemic’Reports of melanoma ’epidemic’– AMA petition to ban sunlampsAMA petition to ban sunlamps– Citizen’s petition to increase enforcementCitizen’s petition to increase enforcement– International Harmonization (IEC TC 61, 335-2-27)International Harmonization (IEC TC 61, 335-2-27)– Technology and our knowledge base has changed Technology and our knowledge base has changed

since 1985 (orig. std. published 1979)since 1985 (orig. std. published 1979)

ANPRM Proposals

1.1. Update recommended exposure Update recommended exposure scheduleschedule

(Current research @ FDA addressing this)(Current research @ FDA addressing this)

2.2. Make new recommended exposure Make new recommended exposure schedule part of the actual standardschedule part of the actual standard

3.3. Clarify the definition of “manufacturer” Clarify the definition of “manufacturer” i.e. that it includes “significant i.e. that it includes “significant modification” of a sunlamp productmodification” of a sunlamp product

ANPRM Proposals – ct’d

4.4. Update warning label Update warning label

5. Require warning label to be reproduced in 5. Require warning label to be reproduced in catalogs, advertising literature, etccatalogs, advertising literature, etc

6. Develop a uniform rating scale for replacement 6. Develop a uniform rating scale for replacement lamps to: lamps to: – simplify the tasks of salon owners and inspectors, andsimplify the tasks of salon owners and inspectors, and– increase safety increase safety

(FDA has sponsored 2 mtgs. re: this issue since 1998)(FDA has sponsored 2 mtgs. re: this issue since 1998)

Review of Recent HistoryReview of Recent History

May, 2002 TEPRRSCMay, 2002 TEPRRSC

1.1. Simplified Warning LabelSimplified Warning Label

2.2. Require Label be reproduced in advertising Require Label be reproduced in advertising literature, brochures, etcliterature, brochures, etc

3.3. Definition of ManufacturerDefinition of Manufacturer

4.4. Revised specifications for eyewearRevised specifications for eyewear

TEPRSSC gave tentative go-ahead on all TEPRSSC gave tentative go-ahead on all but 3but 3rdrd proposal proposal – – understanding there would be 90 to 120-day understanding there would be 90 to 120-day

comment period after the official proposed comment period after the official proposed rule published in Federal Register rule published in Federal Register

(Proposals 1, 3 and 4 have been ‘fine-tuned’ since 2002 (Proposals 1, 3 and 4 have been ‘fine-tuned’ since 2002 meeting in order to better harmonize with IEC)meeting in order to better harmonize with IEC)

Relevant Events since May 2002

October, 2002 – International committee for sunlamp standards (IEC TC 61, MT 16) met in London (Sharon Miller and Janusz Beer from FDA attended)

June, 2003 – IEC TC 61, MT 16 met in Helsinki, Finland(Sharon Miller and Janusz Beer from FDA attended)

June, 2003 – Joint meeting of the FDA, American Academy of Dermatology (AAD) and the American Society for Photobiology (ASP) on indoor tanning

(Organized by Howard Cyr; Sharon Miller, Janusz Beer, Marilyn Lightfoote and Jerry Dennis attended)

October, 2002 IEC Meeting

Items discussed:Items discussed:1.1. Incorporation of the new CIE action spectrum for Incorporation of the new CIE action spectrum for

Non-melanoma skin cancer (NMSC).Non-melanoma skin cancer (NMSC).2.2. Classification of sunlamp products according to Classification of sunlamp products according to

NMSC-effective output. Additional class (Type 5) NMSC-effective output. Additional class (Type 5) was added to include products that had been was added to include products that had been previously excluded.previously excluded.

3.3. Absolute cap on UV irradiance (1 W/cmAbsolute cap on UV irradiance (1 W/cm22 – NMSC- – NMSC-weighted) from sunlamp products accepted.weighted) from sunlamp products accepted.

4.4. Decision to liaise with IEC TC 34 (lamp Decision to liaise with IEC TC 34 (lamp measurement committee) to develop acceptable measurement committee) to develop acceptable replacement lamp coding scheme.replacement lamp coding scheme.

June, 2003 IEC Meeting

Items discussed:Items discussed:

1.1. Detailed evaluation and modification of the Detailed evaluation and modification of the Instructions for Use, including limiting the use Instructions for Use, including limiting the use of products by minors.of products by minors.

2.2. Replacement Lamps. Members of IEC TC 34A Replacement Lamps. Members of IEC TC 34A attended and a compromise was reached re: attended and a compromise was reached re: how to evaluate and designate low-pressure how to evaluate and designate low-pressure UV lamps according to their biologically-UV lamps according to their biologically-effective output. effective output.

June, 2003 Meeting with AAD and ASP

FDA presented information about regulations on FDA presented information about regulations on sunlamp products and current research in this sunlamp products and current research in this area.area.AAD concerned:AAD concerned:seeing increased use of sunlamp products over last seeing increased use of sunlamp products over last

few decades, especially among young women and few decades, especially among young women and even children. even children.

increased rates of skin cancer among Americans. increased rates of skin cancer among Americans.

AAD members asked FDA to make warnings AAD members asked FDA to make warnings against indoor tanning stronger and plan to send against indoor tanning stronger and plan to send petitions to the FDA Commissioner to this effect.petitions to the FDA Commissioner to this effect.

Proposed Amendment 1

Warning LabelWarning LabelExisting Label:Existing Label:DANGER-DANGER-Ultraviolet radiation. Follow instructions. Avoid Ultraviolet radiation. Follow instructions. Avoid

overexposure. As with natural sunlight, overexposure can cause overexposure. As with natural sunlight, overexposure can cause eye and skin injury and allergic reactions. Repeated exposure eye and skin injury and allergic reactions. Repeated exposure may cause premature aging of the skin and skin cancer. WEAR may cause premature aging of the skin and skin cancer. WEAR PROTECTIVE EYEWEAR; FAILURE TO MAY RESULT IN PROTECTIVE EYEWEAR; FAILURE TO MAY RESULT IN SEVERE BURNS OR LONG-TERM INJURY TO THE EYES. SEVERE BURNS OR LONG-TERM INJURY TO THE EYES. Medications or cosmetics may increase your sensitivity to the Medications or cosmetics may increase your sensitivity to the ultraviolet radiation. Consult physician before using sunlamp if ultraviolet radiation. Consult physician before using sunlamp if you have a history of skin problems or believe yourself you have a history of skin problems or believe yourself especially sensitive to sunlight. If you do not tan in the sun, you especially sensitive to sunlight. If you do not tan in the sun, you are unlikely to tan from use of this product.are unlikely to tan from use of this product.

Proposed Revised Label:

WARNING - Ultraviolet radiation may cause:injury to the eyes and skinskin agingskin cancer.

Read instructions carefully.Wear protective eyewear provided.Certain medicines and cosmetics may increase

sensitivity to ultraviolet radiation. Consult your physician.

* Lettering of at least ten (10) millimeters height for the word “Warning” and five * Lettering of at least ten (10) millimeters height for the word “Warning” and five (5) millimeters for the rest of the label information is recommended to meet (5) millimeters for the rest of the label information is recommended to meet the visibility requirements specified in 1010.3.the visibility requirements specified in 1010.3.

Proposed Amendment 2

Inclusion of warning label into catalogues, Inclusion of warning label into catalogues, specification sheets and descriptive specification sheets and descriptive brochuresbrochures

Consistent with req. in the laser stdConsistent with req. in the laser std

Proposed Amendment 3

Significant modification of a Significant modification of a sunlamp product means sunlamp product means recertification as a “manufacturer”recertification as a “manufacturer”

Consistent with req. in the laser std.Consistent with req. in the laser std.

The modification of a sunlamp product, previously The modification of a sunlamp product, previously certified under Sec. 1010.2, by any person certified under Sec. 1010.2, by any person engaged in the business of manufacturing, engaged in the business of manufacturing, assembling, or modifying sunlamp products shall assembling, or modifying sunlamp products shall be construed as manufacturing under the act if be construed as manufacturing under the act if the modification affects any aspect of the the modification affects any aspect of the product's performance or intended function(s) for product's performance or intended function(s) for which this section has an applicable which this section has an applicable requirement. The manufacturer who performs requirement. The manufacturer who performs such modification shall recertify and re-identify such modification shall recertify and re-identify the product in accordance with the provisions the product in accordance with the provisions

of Secs. 1010.2. and 1010.3.of Secs. 1010.2. and 1010.3.

Examples of “significant modification”

Replacing original lamps with lamps that Replacing original lamps with lamps that are “incompatible”are “incompatible”

Increasing the maximum timer settingIncreasing the maximum timer setting

Removing required labeling or replacing Removing required labeling or replacing original labeling with labeling that would original labeling with labeling that would render the product ‘noncompliant’render the product ‘noncompliant’

Proposed Amendment 4

Protective Eyewear Requirements:Protective Eyewear Requirements:

Current language in standard:Current language in standard: “ “the spectral transmittance shall not exceed a the spectral transmittance shall not exceed a

value of 0.001 over the wavelength region 200 to value of 0.001 over the wavelength region 200 to 320 nm, and a value of 0.01 for 320 to 400 nm, 320 nm, and a value of 0.01 for 320 to 400 nm, and shall be sufficient over the wavelength and shall be sufficient over the wavelength region > 400 nm to enable the user to see region > 400 nm to enable the user to see clearly enough to reset the timer”clearly enough to reset the timer”

Proposed Revised Requirements

Same UV limitsSame UV limits

For Visible region (> 400 nm), a more For Visible region (> 400 nm), a more quantitative definition:quantitative definition:

” ”the luminous transmittance shall not the luminous transmittance shall not be less than 1% over the 380 to 780 be less than 1% over the 380 to 780 nm wavelength region”nm wavelength region”

Luminous Transmittance

780

380

780

380

)()(

)()()(

dSy

dSyT

780

380

780

380

)()(

)()()(

dSy

dSyT

dSy

dSyT

)()(

)()()(

780

380

780

380

Where:

Y(Y() = Relative Luminous Efficiency ) = Relative Luminous Efficiency Function of the Human EyeFunction of the Human Eye

S(S() = Relative Spectral Emittance of ) = Relative Spectral Emittance of Standard Illuminant A as defined by CIEStandard Illuminant A as defined by CIE

Cap on Spectral Transmittance

““and the unweighted transmittance (and the unweighted transmittance (<< 5 5 nm intervals) over the 400 to 550 nm nm intervals) over the 400 to 550 nm region shall not exceed 5%”. region shall not exceed 5%”.

This second requirement is currently part of the This second requirement is currently part of the International Standard for sunlamp products International Standard for sunlamp products

(IEC 60335-2-27).(IEC 60335-2-27).

However, recent data obtained from our FDA laboratory However, recent data obtained from our FDA laboratory in Winchester, MA reveals that some eyewear currently in Winchester, MA reveals that some eyewear currently on the market cannot meet the 5% cap. on the market cannot meet the 5% cap.

So, we propose that these types of products be required So, we propose that these types of products be required to bear a tag reading:to bear a tag reading:

"Does not provide adequate eye protection in sunlamp products with high pressure lamps in the facial area" 

In addition, these types of eyewear could not be sold with a high pressure sunlamp product.

Rationale: high pressure lamps are more likely to pose a Rationale: high pressure lamps are more likely to pose a hazard to the retina from visible light than fluorescent hazard to the retina from visible light than fluorescent lamps because of their smaller image size.lamps because of their smaller image size.

Proposed Amendment 5 (a)

Replace the currently-used (by FDA) Replace the currently-used (by FDA) ‘CIELYTLE’ erythema action spectrum with the ‘CIELYTLE’ erythema action spectrum with the internationally-accepted CIE Reference action internationally-accepted CIE Reference action spectrum for erythema.spectrum for erythema. This action spectrum has been extensively studied This action spectrum has been extensively studied

and confirmed as accurate in several laboratories and confirmed as accurate in several laboratories worldwide.worldwide.

Used by FDA in Sunscreen MonographUsed by FDA in Sunscreen MonographUsed by meteorological groups and National Weather Used by meteorological groups and National Weather

Service who define UV Index for solar irradianceService who define UV Index for solar irradianceHarmonize with international standards for sunlampsHarmonize with international standards for sunlamps

FDA Erythema vs CIE Erythema

1.00E-04

1.00E-03

1.00E-02

1.00E-01

1.00E+00

250 270 290 310 330 350 370 390 410

Wavelength (nm)

Rel

ativ

e Eff

ecti

venes

s

FDACIE

Proposed Amendment 5 (b)

Adopt internationally-accepted definition of Adopt internationally-accepted definition of Minimal Erythemal Dose (MED) Minimal Erythemal Dose (MED)

MED = 200 J/mMED = 200 J/m22

(FDA currently uses 156 J/m(FDA currently uses 156 J/m22))

Maximum Timer Limit is currently Maximum Timer Limit is currently 4 MEDs4 MEDsIn order to maintain same biological dose, In order to maintain same biological dose, new timer limit = new timer limit = 3 MEDs3 MEDs using ‘new’ using ‘new’ action spectrum and ‘new’ definition of action spectrum and ‘new’ definition of MED ( MED ( 600 J/m^2-eff)600 J/m^2-eff)

Proposed Amendment 6

Replacement Lamps – Coding SchemeReplacement Lamps – Coding SchemeCurrent situation relies on relative Current situation relies on relative

comparison; i.e. two individual lamps must be comparison; i.e. two individual lamps must be within +/- 10% of erythemal and melanogenic within +/- 10% of erythemal and melanogenic effectiveness in order to be considered effectiveness in order to be considered ‘compatible’‘compatible’

Absolute system that involves lamp code is Absolute system that involves lamp code is needed to solve problems associated w/ needed to solve problems associated w/ current systemcurrent system

Current LabelingCurrent Labeling

SUNLAMP - DANGER-

ULTRAVIOLET RADIATION. FOLLOW INSTRUCTIONS.USE ONLY IN FIXTURE EQUIPPED WITH A TIMER.

Proposed Labeling Scheme

Wattage – Reflector code – UV codeWattage – Reflector code – UV code

– Wattage = nominal lamp wattage, marked Wattage = nominal lamp wattage, marked “watts” or “W”“watts” or “W”

Reflector code

OO for non-reflector lamps for non-reflector lamps

BB for lamps with a broad reflector angle for lamps with a broad reflector angle > 230° > 230°

N N for lamps with a narrow reflector anglefor lamps with a narrow reflector angle < < 200°200°

RR for lamps with a regular reflector for lamps with a regular reflector 200° 200° << << 230° 230°

UV CodeUV Code

UV Code = X/YUV Code = X/Y

X = total erythemal-effective irradiance X = total erythemal-effective irradiance

(250 to 400 nm)(250 to 400 nm)

Y = ratio of NMSC-effective irradianceY = ratio of NMSC-effective irradiance

(250 to 320 nm/320 to 400 nm)(250 to 320 nm/320 to 400 nm)

SOP for lamp measurementsSOP for lamp measurements

Irradiance shall be measured under Irradiance shall be measured under standardized conditions as specified in standardized conditions as specified in IEC 1228 – Method of Measuring and IEC 1228 – Method of Measuring and Specifying Fluorescent Ultraviolet Lamps Specifying Fluorescent Ultraviolet Lamps used for Tanningused for Tanning

Irradiance from a single lamp shall be Irradiance from a single lamp shall be either measured at a distance of 25 cm or either measured at a distance of 25 cm or corrected to irradiance at 25 cmcorrected to irradiance at 25 cm

Erythema vs. NMSC action spectra

1.00E-04

1.00E-03

1.00E-02

1.00E-01

1.00E+00

250 270 290 310 330 350 370 390 410

Wavelength (nm)

Rel

ativ

e E

ffect

iven

ess

CIE ErythemaCIE NMSC

Acceptable Ranges

Lamps will be considered to be acceptable Lamps will be considered to be acceptable replacements if ‘X’ and ‘Y’ components are replacements if ‘X’ and ‘Y’ components are within +/- 10% of those of the original lamps.within +/- 10% of those of the original lamps.

For example, in sunbed where original lamp For example, in sunbed where original lamp code = 100 W – R – 47/3.2code = 100 W – R – 47/3.2– Suitable replacements:Suitable replacements:

100 W – R – (42 to 52)/(2.3 to 3.8)100 W – R – (42 to 52)/(2.3 to 3.8)

e.g. 100 W – R – 42/2.3e.g. 100 W – R – 42/2.3

100 W– R – 52/3.8100 W– R – 52/3.8

Future Proposals?

Recommended Exposure Schedules Recommended Exposure Schedules (when FDA study complete)(when FDA study complete)

Additional changes instituted by Additional changes instituted by International Committee during our International Committee during our standards promulgation processstandards promulgation process

Request for vote on proposalsRequest for vote on proposals

1. Warning Label – revised

2. Require warning label be reproduced in catalogues, brochures, etc

3. Clarify definition of manufacturer

4. Revised protective eyewear specs

5. Adopt CIE erythema a.s. and new MED

6. Replacement Lamp coding scheme