1. Sunlamps: Scientific and Regulatory Issues W. Howard Cyr &Sunlamp Working Group. Center for Devices and Radiological Health Regulatory Meeting, Baltimore, August 16, 2001

2. Background TEPRSSC - Two years ago – presented 5 possible amendments –Our assessment in 2002 – these were “non-controversial” –Reality – “major concerns from affected industry

3. “ Controversial” proposals Place existing recommended exposure schedule into the regulations Use Non-melanoma action spectrum in addition to erythemal action spectrum Exposure schedules and action spectra are subjects of research and standards development

4. Interactions with stakeholders At the suggested of TEPRSSC –Meeting on September 13, 2000 to discuss “controversial issues” –Meeting on February 7 and 8, 2002 to discuss lamp compatibility

5. Exposure Schedules CDRH convinced that more research was necessary on recommended exposure schedules –Measurement techniques of skin sensitivity to UV - >100 human subjects –New project on doses for producing and maintaining tans

6. Action spectra Debate over the use of NMSC action spectrum Debate over annual limits Effect on industry because of “cancer” scares

7. Four Revised Proposals Revised warning label Inclusion of label into catalogues, specification sheets, and descriptive brochures Significant modification means re- certification as a “manufacturer” Revised specification for eyewear

8. Rationale for Revised Proposals Clearer, “user friendly” warning label Warnings in home-use products and in advertisements (new) Requirements of a “manufacturer” in Performance Standard, per se Eyewear requirement consistent with international consensus standards

9. Existing Warning Label 1 DANGER-Ultraviolet radiation. Follow instuctions. Avoid overexposure. As with natural sunlight, overexposure can cause eye and skin injury and allergic reactions. Repeated exposure may cause premature aging of the skin and skin cancer.

10. Existing Warning Label 2 WEAR PROTECTIVE EYEWEAR. FAILURE TO MAY RESULT IN SEVERE BURNS OR LONG-TERM INJURY TO THE EYES. Medications or cosmetics may increase your sensitivity to the ultraviolet radiation.

11. Existing Warning Label 3 Consult physician before using sunlamp is you have a history of skin problems or believe yourself especially sensitive to sunlight. If you do not tan in the sun, you are unlikely to tan from use of this product.

12. Revised Warning Label WARNING - Ultraviolet radiation may cause: –injury to the eyes and skin –skin aging –skin cancer. Read instructions carefully. Wear protective goggles provided. Certain medicines and cosmetics may increase sensitivity to ultraviolet radiation

13. Warning labels FDA proposes: …in all catalogs, specifications sheets, and descriptive brochures and any other purchasing information pertaining to each sunlamp product and ultraviolet lamp, a legible reproduction of the warning statement required by 21 CFR 1040.20(d)(1)(I) shall be affixed

14. Manufacturer “The modification of a sunlamp product, previously certified under 21 CFR 1010.2, by any person engaged in the business of manufacturing, assembling, or modifying sunlamp products shall be construed as manufacturing under the act if...

15. Manufacturer 2 “… the modification affects any aspect of the product’s performance or intended function(s) for which this section (21 CFR 1040.20) have an applicable requirement. The manufacturer who performs such modification shall recertify and re-identify the product in accordance with 21 CFR 1010.2 and 1010.3”

16. Eyewear Current FDA: “the spectral transmittance shall not exceed a value of 0.001 over the wavelength region 200 to 320 nm, and a value of 0.01 for 320 to 400 nm, and shall be sufficient over the wavelength region > 400 nm to enable user to see clearly enough to reset the timer”

17. Eyewear Proposed: –same UV limits –for visible region, a more quantitative definition: “the luminous transmittance shall not be less than 1% over the 400 to 550 nm wavelength region” –describe measurement techniques

18. Other Issues - Update Replacements Lamps - absolute method of determining ‘compatibility’ (should be ready for next TEPRSSC) Discussion issues –Revised Recommended Exposure Schedules –Revised definition of MED –CIE Action Spectra for Erythema and NMSC –Annual limits

19. Summary Present 4 proposed amendments at May 22, 2002 TEPRSSC meeting Add Lamp Compatibility amendment at Fall, 2002 TEPRSSC meeting Continue evaluations and laboratory studies on other issues Work on international harmonization