[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]


=======================================================================
-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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