[Federal Register Volume 64, Number 26 (Tuesday, February 9, 1999)]
[Proposed Rules]
[Pages 6288-6290]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-3109]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 1020
[Docket No. 98N-1170]
Medical Devices; Sunlamp Products Performance Standard; Request
for Comments and Information
AGENCY: Food and Drug Administration, HHS.
ACTION: Advance notice of proposed rulemaking.
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SUMMARY: The Food and Drug Administration (FDA) is announcing its
intent to propose amendments to the performance standard for sunlamp
products. The agency is taking this action to address concerns about
the adequacy of the warnings on sunlamp products, current recommended
exposure schedule to minimize risk to customers who choose to produce
and maintain a tan, current labeling for replacement lamps, and current
health warnings which do not reflect recent advances in photobiological
research. FDA is soliciting comments and information from interested
persons concerning the subject matter of the proposed amendments.
DATES: Written comments by May 10, 1999.
ADDRESSES: Submit written comments to the Dockets Management Branch
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. Individuals or organizations wishing to receive
copies of draft amendments or related documents distributed for review
during the development of these amendments may have their names placed
on a mailing list by writing to Office of Science and Technology (HFZ-
114), Center for Devices and Radiological Health, Food and Drug
Administration, 5600 Fishers Lane, Rockville, MD 20857, FAX 301-594-
6775, e-mail address [email protected]
FOR FURTHER INFORMATION CONTACT: W. Howard Cyr, Center for Devices and
Radiological Health (HFZ-114), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-443-7179.
[[Page 6289]]
SUPPLEMENTARY INFORMATION:
I. Background
The Safe Medical Devices Act of 1990 (Pub. L. 101-629), enacted on
November 28, 1990, transferred the provisions of the Radiation Control
for Health and Safety Act of 1968 (Pub. L. 90-602) from Title III of
the Public Health Service Act to Chapter V, subchapter C of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 360hh et seq.). This authority
provides for developing, amending, and administering radiation safety
performance standards for electronic products.
Sunlamp products are class I medical devices exempt from premarket
notification requirements (21 CFR 878.4635). These products are
intended to provide ultraviolet (UV) radiation to tan the skin. As
class I devices, sunlamp products are subject to general controls such
as registration, listing, and current good manufacturing practices.
Sunlamp products are also subject to the regulations for electronic
product radiation control including parts 1000 through 1010 and
Sec. 1040.20 (21 CFR parts 1000 through 1010 and 21 CFR 1040.20).
The sunlamp performance standard in Sec. 1040.20 was originally
published in the Federal Register of November 9, 1979 (44 FR 65352). On
September 6, 1985 (50 FR 36548), FDA amended Sec. 1040.20 and made it
applicable to all sunlamp products manufactured on or after September
8, 1986. On August 21, 1986, FDA issued a guidance entitled ``Policy on
Maximum Timer Interval and Exposure Schedule for Sunlamp Products.''
The guidance explained the criteria FDA uses to evaluate the adequacy
of the exposure schedule and the recommended maximum exposure time for
sunlamp products. On September 2, 1986, FDA issued another guidance
entitled ``Policy on Lamp Compatibility.'' The guidance listed the
criteria FDA uses to evaluate lamp compatibility for sunlamp products.
Before proposing any electronic product performance standards, FDA
is required to consult a statutory advisory committee, the Technical
Electronic Product Radiation Safety Standards Committee (TEPRSSC) (21
U.S.C. 360kk(f)(1)(A)). At the September 23 and 24, 1998, meeting of
TEPRSSC, FDA presented general concepts for amendments to the
performance standard for sunlamp products. The committee recommended
that FDA pursue development of the amendments. FDA intends to present
more specific proposals to amend the performance standard to TEPRSSC
prior to the publication of a proposed rule in the Federal Register.
FDA is concerned that inadequate attention is being paid to the
recommended exposure schedule which should be designed to minimize
risks for those who choose to produce and maintain a tan. FDA is
further concerned that the warnings for sunlamp products are not
reaching many users of sunlamp products and that the existing exposure
schedule does not take into account the variations in individual human
UV sensitivity. In order to update the current sunlamp product
standards, FDA is considering revising Sec. 1040.20.
In addition, sunlamp technology continues to change. These changes
can affect both the intensity and the spectral characteristics of the
UV from sunlamps. Because there is no uniform grading/rating system,
choosing a replacement lamp can be confusing for tanning bed owners.
Owners choosing replacement lamps must consider lamp compatibility as
well as compliance with FDA's performance standard in order to protect
users from excessive exposure to UV.
In addition to concerns about the warnings, labeling, and exposure
schedule, FDA is aware of new research findings that suggest a stronger
association between exposures to ultraviolet radiation and the
increased incidence of skin cancer that has been observed in the U.S.
population. Some of this increase has been linked to intense,
intermittent exposures to solar radiation, but other research suggests
that chronic, less intense exposures to ultraviolet radiation also
contribute to skin cancer. Research has identified the fundamental
chemical damage that occurs in the genetic material of humans and has
linked some skin cancers to changes in specific genes. These scientific
findings have led many in the medical community to strongly suggest
that consumers avoid intense, intermittent exposures (the type that
could produce sunburns) to ultraviolet radiation, and also minimize
other UV exposures as well.
There are other deleterious effects from human exposure to UV
radiation. They include blistering burns, skin erythema, photoaging,
and photoallergic/photosensitive drug interactions. UV radiation may
induce damage in the cornea, lens, and retina of the eye, which in
extreme cases leads to permanent loss of vision. UV exposure is
immunosuppressive, and can have an impact on the development of many
diseases.
Some research has linked skin cancer to exposures to sunlamp
products, and some research has even suggested an association between
the use of sunlamps and malignant melanoma. This association is not
definitive. FDA solicits comments and information as to whether a
warning about possible melanoma induction should be part of sunlamp
labels. To provide users with sufficient information for the safe use
of these devices at tanning salons and for home sunlamp products, FDA
seeks comments and information on suggested changes to the current
sunlamp labels.
After considering the risks, some consumers may still choose to
tan, either by exposure to the sun or by use of sunlamp products. Those
consumers who use sunlamp products should obtain their tan with the
least amount of risk from sunburn and eye damage. Therefore, FDA seeks
advice on a recommended exposure schedule which would minimize the
risks of adverse effects while still producing and maintaining a tan.
II. Revisions Under Consideration
FDA believes that amendment of the current performance standard is
necessary to keep pace with changes in technology and advances in
research related to the use of sunlamp products. The following
discussion is intended to describe the need for the revision and FDA's
proposed approach. Comments received from this advance notice of
proposed rulemaking (ANPRM) will be used to develop any proposed
amendments. Any proposed regulatory changes or standards amendments
will be included in a future proposed rule. FDA is soliciting comments
on all aspects of this ANPRM, and specifically requests comments on the
following proposed amendments:
1. FDA is considering revising and updating the current sunlamp
product performance standard (Sec. 1040.20) and harmonizing it with the
International Electrotechnical Committee Standard 335-2-27 for UV and
infrared emitting appliances. After consulting with international
standards organizations and evaluation of the current scientific
knowledge, FDA intends to develop a recommended exposure schedule which
will become part of the directions for use of the sunlamp product. As
part of the development process, FDA intends to review the material on
effects of UVA and UVB on skin, the effects of UV exposure on melanoma
induction, and the use of photobiological action spectra as a basis for
risk assessment in health protection and product safety discussed at
the American Society for Photobiology and European Society for
Photobiology Joint Workshop on UV and Melanoma, Snowbird, Utah, July 11
[[Page 6290]]
through 15, 1998; the International Symposium and Workshop on
Measurements of Optical Radiation Hazards, at the National Institute
for Standards and Technology, Gaithersburg, MD, September 1 through 3,
1998; and (3) the Research Workshop on Risks and Benefits of Exposure
to Ultraviolet Radiation and Tanning, at the National Institutes of
Health, Bethesda, MD, September 16 through 18, 1998. The proceedings of
these meetings describe current research findings that show a stronger
correlation between UV exposure and skin cancer, photoaging, and
photoimmunological effects.
2. FDA is considering revising and updating its August 21, 1986,
guidance on the determination of the maximum timer interval and
recommended exposure schedule for sunlamp products entitled, ``Policy
on Maximum Timer Interval and Exposure Schedule for Sunlamp Products.''
FDA is concerned that inadequate attention is being paid to current
recommended exposure schedules and that current guidance may allow
higher exposures than are necessary to produce and maintain a tan, and
it does not incorporate the differences in individual human sensitivity
to UV exposure. FDA intends to update this guidance after reviewing and
evaluating material presented at the meetings listed previously and
other available information. FDA is further considering incorporating
the previous guidance into the sunlamp product performance standard
because it believes such incorporation would result in a more
comprehensive regulatory standard with all relevant information for
compliance in the standard.
3. FDA is considering adding a provision clarifying that
manufacturing includes the modification of a sunlamp product,
previously certified under Sec. 1010.2, by any person engaged in the
business of manufacturing, assembling or modifying sunlamp products if
the modification affects any aspect of the product's performance,
information or intended function for which Sec. 1040.20 has an
applicable requirement. This addition would clarify that sunlamp
products are being regulated like other products regulated under
Sec. 1010.2. FDA is also considering requiring the manufacturer who
performs such modification to recertify and re-identify the product in
accordance with the provisions of Secs. 1010.2 and 1010.3. This
potential amendment is intended to clarify the responsibilities of
firms and individuals who are in the business of installing ultraviolet
lamps and new timers with different performance characteristics than
the original lamps and timers in previously certified products.
4. FDA is concerned that the current warning label is not read by
many tanning salon patrons because it is too long and detailed.
Therefore, FDA is considering updating the warning statement required
by Sec. 1040.20(d)(1)(i) to simplify the wording and to highlight the
risk of skin cancers. In order to update the warning statements, FDA
intends to review and evaluate epidemiological and mechanistic
information on UV exposure-related skin cancers, including possibly
fatal cutaneous malignant melanoma. In developing its specific proposal
for this item, FDA will be reviewing the material presented at the
meetings cited previously and other available information.
5. FDA is considering requiring the reproduction of the text of the
warning statement specified in Sec. 1040.20(d)(1)(i) in catalogs,
specification sheets, and brochures pertaining to sunlamp products. FDA
is concerned that consumers who purchase sunlamp products through
catalog mail order or through catalogs on electronic media may not
receive information about the associated hazards and risks until the
products are delivered to their homes and unpacked.
6. To simplify appropriate lamp replacement, FDA is considering the
development of a biological efficacy rating scale for ultraviolet lamps
intended for use in sunlamp products. Lamp technology continues to
evolve, affecting the levels of UV exposure, the spectral
characteristics and, therefore, the biological efficacy of ultraviolet
lamp radiation. At present, a label that specifies the type of lamps
suitable for replacement in the product is required on sunlamp products
and in the user instructions. As new lamps and new lamp manufacturers
enter the marketplace, while other manufacturers abandon the
marketplace, it is increasingly cumbersome to keep track of individual
lamp designations which are compatible with the product and compliant
with the standard. In order to simplify the process, especially for
industry and State regulators, FDA is considering a uniform grading/
rating system.
III. Comments
Interested persons may, on or before May 10, 1999, submit to the
Dockets Management Branch (address above) written comments regarding
this ANPRM. Two copies of any comments are to be submitted, except that
individuals may submit one copy. Comments are to be identified with the
docket number found in brackets in the heading of this document.
Received comments may be seen in the office above between 9 a.m. and 4
p.m., Monday through Friday. This ANPRM is issued under section 531 et
seq. of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360hh et
seq.) and under authority of the Commissioner of Food and Drugs.
Dated: February 2, 1999.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 99-3109 Filed 2-8-99; 8:45 am]
BILLING CODE 4160-01-F
