# Presentation: 430434

## Amendments to the Sunlamp Perfomance Standard

- CDRH Working Group on Sunlamps

## 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

## 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_

## 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

## 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)

## 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

## 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

## 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

## 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

## We will proceed ASAP with five amendments 

- Amendment 4:  Place warnings in _catalogs, spec sheets, and brochures_
- Amendment 5:  Have a _simpler warning label_

## 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

## 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

## 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

## 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

## 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

## Amendment 5: Simpler warning label

- Proceed with a simpler warning label
- Label will be identical or equivalent to the warning label of IEC

## 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

## 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

## 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

## 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

## Ongoing work in IEC

- Timers
- Warning labels
- Protective eyewear
- “Panic” button
- MED - 250 J/m2

- Exposure schedules for different skin types
- Lamp classification - use UV index

## Conclusions 

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