1 Amendments to the Sunlamp Perfomance Standard CDRH Working Group on Sunlamps

2 Review: Why did we publish the ANPRM Reports of a melanoma “epidemic” and a melanoma-sunlamp link Report of UVA - melanoma association AAD and citizen’s petitions Some salon owners - not attentive to regs. Specific amendment proposals from CDRH International harmonization, e.g., IEC

3 What revisions were we considering in the ANPRM? Make exposure schedule part of the standard Lower cumulative doses Use cancer action spectrum, plus erythemal action spectrum Extend exposure schedule to different skin types

4 What revisions were we considering in the ANPRM? Sunlamp product manufacturer = anyone who modifies the product Have a simpler warning label Include a melanoma warning Place warnings in catalogs, spec. sheets, and brochures Have a biological efficacy rating scale for replacement lamps

5 Response to the ANPRM 27 submissions –indoor tanning industry (4) –lamp and sunbed manufacturers (8) –dermatology organizations (2) –academia (3) –salon owners (4) –State and County regulatory agencies (5) –insurance company (1)

6 No plans to ban sunlamps Individual choice - sun and/or salon Risks are fairly well understood by public Informed consent statements are being used Emphasis will be on cooperation, not banning

7 Our approach to amendments Some issues are straightforward, easy to implement, and non-controversial Some issues will require more work, but are also non-controversial Some issues are complex and controversial

8 Our approach to amendments Therefore, we will approach amendments to the Sunlamps Performance Standard in at least two stages –the first stage will address easiest, non- controversial issues –the second stage will require more research and evaluation on complex and controversial issues

9 We will proceed ASAP with five amendments Amendment 1: Make exposure schedule a part of the standard Amendment 2: Use cancer action spectrum, plus erythemal action spectrum Amendment 3: Emphasize that a manufacturer = anyone who modifies product

10 We will proceed ASAP with five amendments Amendment 4: Place warnings in catalogs, spec sheets, and brochures Amendment 5: Have a simpler warning label

11 Amendment 1: Make exposure schedule a part of the standard Current recommended exposure schedule is is in a policy letter of August 21, 1986 We will update current recommended exposure schedule for skin type II and make it a requirement in the Performance Standard

12 Amendment 1: Make exposure schedule a part of the standard We will continue to evaluate other exposure schedules for other skin types for possible use at a later date Future exposure schedules should be –scientifically based, and –preferably part of a national/international consensus

13 Amendment 2: Use cancer and erythemal action spectrum IEC is adopting the action spectrum for squamous cell carcinoma to be used with the erythemal action spectrum New amendment - We propose to follow the lead of IEC and also use the SCC action spectrum

14 Amemendment 3: Manufacturer = anyone who modifies product Anyone who replaces a lamp with an incompatible bulb or changes an intented performance feature becomes a manufacturer - must re-certify and re- identify product Many comments that this requirement be strong. Concerns about insurance coverage

15 Amendment 4: Warnings in catal., spec. sheets and brochures We will proceed with an amendment to require warning labels in catalogs, specification sheets, and brochures

16 Amendment 5: Simpler warning label Proceed with a simpler warning label Label will be identical or equivalent to the warning label of IEC

17 Simpler warning label DANGER ULTRAVIOLET RADIATION Follow instructions -Use protective eyewear Over-exposure causes skin and eye burns Long term use contribute to - –Skin cancers (sometimes fatal) –Wrinkling and sagging of skin Drugs and cosmetics may increase above effects

18 Biological efficacy rating scale for UV lamps Future amendment - incorporate a new rating scale for replacement lamps More effort is needed to finalize such a rating scale Agreement that a rating system is needed Suggestion that the UV index be used as part of the rating system

19 Other possible amendments Possible melanoma warning Lower cumulative doses Exposure schedules for different skin types The suggested amendments will be delayed because there is: –insufficient data to make a decision at this time –more research and evaluation is needed

20 Work with Industry Discussion on industry proposals –consent forms – exposure. Schedules – skin types –UV index –“benefits” Workshop at Inter. Cong. of Photobiology FDA conferences (?) Ongoing discussions and evaluations

21 Ongoing work in IEC Timers Warning labels Protective eyewear “Panic” button MED J/m 2 Exposure schedules for different skin types Lamp classification - use UV index

22 Conclusions Proceed with a Proposed Rule with 5 amendments Continue to work on the other issues for possible future amendments