Amendments to the Sunlamp Perfomance Standard

1
Amendments to the Sunlamp Perfomance Standard

• CDRH Working Group on Sunlamps

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Review Why did we publish the ANPRM

• Reports of a melanoma epidemic and a
  melanoma-sunlamp link
• Report of UVA - melanoma association
• AAD and citizens 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)

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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

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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

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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

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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

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We will proceed ASAP with five amendments

• Amendment 4 Place warnings in catalogs, spec
  sheets, and brochures
• Amendment 5 Have a simpler warning label

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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

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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

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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

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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

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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

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Amendment 5 Simpler warning label

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

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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

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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

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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

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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

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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

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Conclusions

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