[Federal Register Volume 80, Number 245 (Tuesday, December 22, 2015)]
[Proposed Rules]
[Pages 79505-79522]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-32023]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 1002 and 1040

[Docket No. FDA-1998-N-0880 (Formerly 1998N-1170)]
RIN 0910-AG30


Sunlamp Products; Proposed Amendment to Performance Standard

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is proposing 
to amend the performance standard for sunlamp products and ultraviolet 
(UV) lamps intended for use in these products. This standard was last 
amended in 1985. The current amendments seek to improve consumer safety 
by requiring more effective communication regarding the risks posed by 
these products. They also would reduce risks to consumers by updating 
technical requirements to reflect current science, and by adopting and 
incorporating by reference certain elements from the International 
Electrotechnical Commission (IEC) International Standard 60335-2-27, 
Ed. 5.0: 2009-12.

DATES: Submit either electronic or written comments on the proposed 
rule by March 21, 2016. Submit comments on information collection 
issues under the Paperwork Reduction Act of 1995 by January 21, 2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on http://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-1998-N-0880 for ``Sunlamp Products; Proposed Amendment to 
Performance Standard.'' Received comments will be placed in the docket 
and, except for those submitted as ``Confidential Submissions,'' 
publicly viewable at http://www.regulations.gov or at the Division of 
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on http://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. If you do not 
wish your name and contact information to be made publicly available, 
you can provide this information on the cover sheet and not in the body 
of your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.
    Submit comments on information collection issues to the Office of 
Management and Budget (OMB) in the following ways:
     Fax to the Office of Information and Regulatory Affairs, 
OMB, Attn: FDA Desk Officer, FAX: 202-395-7285, or email to 
[email protected]. All comments should be identified with the 
title, ``Sunlamp Products; Proposed Amendment to Performance 
Standard.''

FOR FURTHER INFORMATION CONTACT: Sharon Miller, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 4234, Silver Spring, MD 20993-0002, 301-796-2471.

SUPPLEMENTARY INFORMATION:

Executive Summary

Purpose of the Regulatory Action

    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 (the FD&C Act) (21 U.S.C. 360hh et seq.). 
Under these provisions, FDA administers an electronic product

[[Page 79506]]

radiation control program to protect the public health and safety. This 
authority provides for developing, amending, and administering 
radiation safety performance standards for electronic products, 
including sunlamp products.
    A sunlamp product is a device that emits UV radiation to induce 
tanning. The device incorporates one or more UV lamps as a radiation 
source. Examples of sunlamp products are tanning beds, which are used 
while lying down, and tanning booths, which are used while standing. UV 
radiation-emitting products not used for tanning would not be affected 
by this proposed rule. Devices emitting UV radiation to treat 
dermatological disorders are regulated separately and are not part of 
this proposed rule. As electronic products, sunlamp products are 
subject to the regulations for electronic product radiation control, 
including parts 1000 to 1010 (21 CFR parts 1000 through 1010) and Sec.  
1040.20 (21 CFR 1040.20).
    Sunlamp products emit UV radiation to induce tanning. The adverse 
effects of UV radiation are well known. UV radiation can cause acute 
injuries such as sunburns and eye irritations (e.g., photokeratitis). 
Long-term UV exposure has been associated with skin cancer (including 
squamous cell carcinoma, basal cell carcinoma, and melanoma), skin 
aging, and cataracts. Epidemiological studies of the effects of UV 
radiation on incidence of cancer and other health problems are 
complicated by latency between exposure and disease, difficulty 
controlling for environmental exposure to UV radiation, and other 
factors. Nevertheless, a recent meta-analysis found an increase in the 
risk of melanoma for each additional session of sunlamp product use per 
year (Ref. 1).
    FDA is concerned about the safety risks from UV radiation. 
Therefore, FDA is updating our requirements for sunlamp products which 
allow for indoor exposure to UV radiation. There have been many changes 
in our understanding of how UV radiation interacts with human skin 
since FDA published the document entitled ``Sunlamp Products; 
Performance Standard'' in the Federal Register of September 6, 1985 (50 
FR 36548). There have also been many changes in the indoor tanning 
industry which affect the type of equipment on the market and the 
measurement techniques used by manufacturers. FDA is updating 
requirements for sunlamp products to bring our regulations up to date 
with current science. FDA also wants to improve consumers' 
understanding of the risks related to UV radiation exposure.

Summary of the Major Provisions of the Regulatory Action in Question

    The objective of this proposed rule is to align the performance 
standards for sunlamp products with current scientific knowledge and 
our understanding of how these products are used. This proposed rule 
seeks to facilitate compliance, improve awareness among operators and 
consumers about risks of use, and ultimately improve public health.
    FDA proposes to incorporate certain elements of the International 
Electrotechnical Commission (IEC) International Standard 60335-2-27, 
Ed. 5.0: 2009-12, ``Household and Similar Electrical Appliances--
Safety--Part 2-27: Particular Requirements for Appliances for Skin 
Exposure to Ultraviolet and Infrared Radiation,'' by reference. 
Harmonizing the FDA standard with the current IEC standard would bring 
it up to date with current science and better protect consumers from 
the risks posed by these devices. Harmonization would have benefits for 
sunlamp product manufacturers as well. Currently, many firms producing 
sunlamp products for sale within the United States and abroad have to 
follow both IEC and FDA standards. Aligning these standards would mean 
that such firms would need to comply with a single set of rules instead 
of two different ones, at least for the particular clauses which are 
being adopted and incorporated by reference.
    FDA proposes to amend the requirements of part 1002 as specified in 
table 1 to require that manufacturers of UV lamps intended to be used 
in sunlamp products are subject to the same record and reporting 
requirements as manufacturers of sunlamp products. FDA wants to ensure 
that all test data necessary to ensure compliance with Sec.  1040.20 
are collected and maintained. Currently, manufacturers of UV lamps are 
required to submit only product reports. Under proposed Sec.  1002.1, 
manufacturers of UV lamps would also be required to submit supplemental 
reports and annual reports and to maintain test records and 
distribution records. Moreover, proposed Sec.  1002.1 would also 
require that manufacturers of protective eyewear maintain test records 
demonstrating that the eyewear complies with applicable UV and visible 
transmittance requirements as well as distribution records. In 
addition, proposed Sec.  1002.1 would also require that manufacturers 
of protective eyewear submit annual reports, supplemental reports, and 
product reports to FDA.
    Proposed Sec.  1040.20(c)(1) would set an absolute limit for UVC 
radiation. An absolute limit on UVC (200-290 nanometer (nm)) irradiance 
would provide greater assurance of user safety because a ratio permits 
higher doses of UVC (as long as they correspond to higher doses in the 
260 to 320 nm range). UVC, which is not present in sunlight that 
reaches the Earth's surface, is potentially harmful to users while less 
effective for tanning than UVA or UVB. FDA has chosen not to adopt the 
limit for UVC radiation in Ed. 5.0 of IEC 60335-2-27 because this limit 
is 10 times lower than the limit in Ed. 4.2 and FDA believes that it 
would be difficult for some manufacturers to measure irradiance at this 
level.
    Proposed Sec.  1040.20(c)(2)(ii) would limit the maximum timer 
interval to one that would result in a biologically effective (also 
referred to as erythemal-effective) dose that would not exceed 500 
joules/meter\2\ (J/m\2\) which is approximately equivalent to the 624 
J/m\2\ value (weighted with the CIE LYTLE action spectrum) that was 
specified in the 1986 FDA Policy Letter on Maximum Timer Interval and 
Exposure Schedule. FDA has determined that a dose of 500 J/m\2\ 
(weighted with the CIE erythemal action spectrum) provides a 
biologically equivalent dose that is more closely matched to the 
current 624 J/m\2\ value than does the IEC dose limit of 600 J/m\2\.
    Proposed Sec.  1040.20(c)(3) would add a requirement that the 
control enabling manual termination of radiation emission (sometimes 
referred to as the ``panic button'' or ``emergency stop'') be easily 
accessible and readily identifiable to the user. This would ensure that 
users could easily turn the sunlamp product off for any reason.
    Proposed Sec.  1040.20(c)(4)(ii) would expand application of the 
performance requirements to all protective eyewear intended to be used 
with sunlamp products, whether sold together with a sunlamp product or 
sold separately. UV wavelengths can cause serious eye damage, and 
exposure to the shorter wavelength region of the UV spectrum is 
especially dangerous. The spectral transmittance requirements for 
protective eyewear are necessary to protect users of sunlamp products 
from these risks, which directly result from the UV radiation emitted 
by the sunlamp product.
    Proposed Sec.  1040.20(d)(1)(i) would modify the warning statement 
required to appear on the label of all sunlamp products. FDA believes 
that the current warning statement is too long, not user-friendly, and 
that its content and format could be improved to more effectively

[[Page 79507]]

communicate the risks of indoor tanning to users. Based on its analysis 
of the consumer testing, FDA concluded that the current warning 
statement could be made more effective by changing its required 
language, formatting, and location. FDA believes that the proposed 
warning statement would most effectively convey the risks of indoor 
tanning to users.
    The proposed rule would also improve user safety by adopting the 
IEC's ``equivalency code'' system for ensuring compatibility between 
sunlamp products (e.g., tanning beds and booths) and the UV lamps that 
are used in them. Proposed Sec.  1040.20(d)(1)(vi) would require the 
label of all sunlamp products to indicate the equivalency code range of 
the UV lamp to be used in the sunlamp product. Proposed Sec.  
1040.20(d)(2)(ii) would require the label of each UV lamp to indicate 
its UV lamp equivalency code. FDA believes the adoption of the IEC's 
absolute rating system for replacement UV lamps would eliminate 
confusion regarding proper lamp replacement, facilitate the enforcement 
of lamp compatibility requirements, and improve the safety of sunlamp 
products.
    Proposed Sec.  1040.20(d)(3) would retain the requirement of the 
current FDA standard that the required label information must be 
legible and readily accessible to view by a sunlamp product user 
immediately prior to use. Proposed Sec.  1040.20(d)(3)(i) would 
incorporate specifications into the rule regarding the location, 
spacing, and font of the required warning statement. FDA believes that 
these label specifications would ensure that users see the required 
warning prior to use, and would result in a more comprehensive and 
effective standard.
    Proposed Sec.  1040.20(e)(3) would add a requirement for the 
provision of the required warning statement in all catalogs, 
specification sheets, and descriptive brochures intended for consumers 
in which sunlamp products are offered for sale, and on all consumer-
directed Web pages on which sunlamp products are offered for sale. This 
requirement would ensure that consumers are fully informed of the risks 
presented by sunlamp products at the time they consider purchasing it.
    Proposed Sec.  1040.20(g) is also modeled after the proposed FDA 
Performance Standard for Laser Products (78 FR 37723, June 24, 2013). 
FDA believes the addition of these requirements, which have been used 
successfully over the past two decades for laser products, would 
improve safety by ensuring that modifications that affect performance 
would be held to the same standards as original manufacturing.

Costs and Benefits

    Estimated one-time costs are $20,917 to $113,240 and annual costs 
are $4,686 to $7,230. The present discounted costs are $57,181 to 
$151,390 at 7 percent and $61,498 to $165,883 at 3 percent. Annualized 
at 7 percent over 10 years, total costs are $8,141 to $21,498. At 3 
percent, annualized total costs are $7,867 to $19,447.
    The primary benefit of the proposed rule would be from reduced 
injuries, including sunburn, photokeratitis, skin cancer, cataracts and 
ocular melanoma, and from reduced exposure to UV radiation. We are 
unable to quantify the benefits, but where possible, demonstrate that 
they satisfy breakeven tests using very conservative assumptions. The 
benefits of this proposed rule would justify the costs.

Table of Contents

I. Background
II. Contents of the Proposed Regulation
    A. Overview
    B. Changes to Sec.  1002.1
    C. Changes to Sec.  1040.20
III. Legal Authority
IV. Proposed Effective Date
V. Environmental Impact
VI. Analysis of Impacts
VII. Federalism
VIII. Paperwork Reduction Act of 1995
    A. Reporting Burden
    B. Recordkeeping Burden
    C. Third Party Disclosure Burden
IX. Incorporation by Reference
X. Comments
XI. References

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 FD&C 
Act (21 U.S.C. 360hh et seq.). Under these provisions, FDA administers 
an electronic product radiation control program to protect the public 
health and safety. This authority provides for developing, amending, 
and administering radiation safety performance standards for electronic 
products, including sunlamp products.
    Until recently, sunlamp products intended for tanning were class I 
medical devices and exempt from premarket notification requirements, 
subject to the limitation in 21 CFR 878.9 (see 53 FR 23856, June 24, 
1988; 59 FR 63005, December 7, 1994). On March 25, 2010, FDA held a 
meeting of the General and Plastic Surgery Devices Panel of the FDA/
Center for Devices and Radiological Health (CDRH) Medical Devices 
Advisory committee to seek input on whether the classification or 
regulatory controls needed to be changed. For a summary of this 
meeting, see http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/GeneralandPlasticSurgeryDevicesPanel/UCM206522.pdf. On June 2, 2014, based on the panel's recommendations, 
among other things, FDA reclassified UV lamps intended to tan the skin 
from class I and exempt from premarket notification to class II and 
subject to premarket notification, and renamed them sunlamp products 
and UV lamps intended for use in sunlamp products (see 21 CFR 878.4635; 
79 FR 31205, June 2, 2014).
    As electronic products, sunlamp products are subject to the 
regulations for electronic product radiation control, including parts 
1000 through 1010 and Sec.  1040.20. The sunlamp products performance 
standard in Sec.  1040.20 was originally published in the Federal 
Register on November 9, 1979 (44 FR 65352). In the Federal Register of 
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.
    FDA also issued several policy letters pertaining to specific 
aspects of its regulation of sunlamp products. On June 25, 1985, FDA 
issued a policy letter entitled ``Policy on Warning Label Required on 
Sunlamp Products'' (available at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM095333.pdf) (Ref. 2). This document pertained to the location, 
spacing, and legibility of the required warning label. On August 21, 
1986, FDA issued a policy letter entitled ``Policy on Maximum Timer 
Interval and Exposure Schedule for Sunlamp Products'' (available at 
http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM095333.pdf) (Ref. 3). 
This document 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 policy 
letter entitled ``Policy on Lamp Compatibility,'' (available at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM095325.pdf) (Ref. 4). This document listed the 
criteria FDA uses to

[[Page 79508]]

evaluate appropriate replacement lamps for sunlamp products.
    Before prescribing any electronic product performance standards, 
FDA is required to consult a statutory advisory committee, the 
Technical Electronic Product Radiation Safety Standards Committee 
(TEPRSSC). See section 534(f)(1)(A) of the FD&C Act (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, which are embodied in this proposed 
rule. The committee recommended that FDA pursue development of the 
amendments.
    On February 9, 1999, CDRH published an Advance Notice of Proposed 
Rulemaking (ANPRM) (Docket No. 98N-1170), 64 FR 6288 (February 9, 
1999), for the following reasons:
    1. FDA was concerned that inadequate attention was being given to 
recommended exposure schedules, which are designed to minimize consumer 
risk.
    2. FDA was concerned that the warnings for sunlamp products were 
not reaching many users of sunlamp products prior to their purchase and 
use, and that purchasers may not be aware of the risks associated with 
UV exposure from sunlamp products.
    3. Sunlamp products technology has changed since the FDA 
Performance Standard was amended in 1985. These changes can affect both 
the intensity and spectral characteristics of the UV emission from 
sunlamps.
    4. Because there is no uniform grading/rating system, choosing a 
replacement lamp can be confusing for sunlamp product owners and 
tanning facilities. It also makes the job of tanning facility 
inspectors more difficult because they cannot easily verify whether the 
correct lamps are installed in the sunlamp products. The use of 
incorrect replacement lamps can lead to sunburns.
    The specific amendments under consideration were as follows:
    1. Harmonizing the sunlamp product performance standard with IEC 
Standard 60335-2-27;
    2. Revising and updating the August 21, 1986, guidance entitled 
``Policy on Maximum Timer Interval and Exposure Schedule for Sunlamp 
Products,'' and incorporating the updated guidance into the sunlamp 
product performance standard;
    3. Adding a provision clarifying that ``manufacturing'' under the 
FD&C Act includes a modification of a sunlamp product that affects any 
aspect of its performance or intended function for which Sec.  1040.20 
has an applicable requirement;
    4. Updating the warning statement required by Sec.  
1040.20(d)(1)(i) to simplify the wording and to highlight the risk of 
developing skin cancers;
    5. Requiring reproduction of the text of the warning statement 
specified in Sec.  1040.20(d)(1)(i) in catalogs, specification sheets, 
and brochures; and
    6. Developing a biological efficacy rating scale for UV lamps 
intended for use in sunlamp products to simplify appropriate lamp 
replacement.
    In response to this ANPRM, FDA received 26 comments from State and 
local radiation control agencies, manufacturers, the American Academy 
of Dermatology, the Skin Cancer Foundation, an industry educational 
association, a tanning facility owner, and a trade organization. FDA 
considered these comments in developing this proposal.
    FDA presented recommendations for amendments to the sunlamp 
performance standard to TEPRSSC on June 21, 2000. FDA explained to 
TEPRSSC that it was prepared to move forward with some of the 
amendments at that time, but did not have sufficient scientific data to 
move forward with the lamp classification or the exposure schedule 
amendment. TEPRSSC advised FDA to develop scientifically-based exposure 
schedule guidelines before incorporating these requirements into the 
Performance Standard itself. FDA scientists obtained special funding 
from FDA's Office of Women's Health to conduct this research. Upon 
completion, FDA presented guidelines for exposure schedules to the IEC 
TC (Technical Committee) 61, MT (Maintenance Team) 16 that is 
responsible for developing standards for these products. The IEC 
accepted these guidelines and incorporated them into IEC 60335-2-27 
standard (Ed. 5.0), which published on December 14, 2009.
    In February 2002, FDA held a 2-day meeting with the indoor tanning 
industry and representatives from the U.S. Army Environmental Hygiene 
Agency, Health Canada, the Swedish Radiation Protection Institute, and 
the North Carolina Department of Radiation Protection. The purpose of 
this meeting was to solicit input from the affected parties on the lamp 
equivalence issue and other possible amendments to the FDA Performance 
Standard for Sunlamp Products, which we considered in the development 
of this proposed rule.
    The IEC TC 61, MT 16 committee met in October 2002, and decided to 
work with IEC SC (subcommittee) 34A to develop practical standardized 
test methods and a classification scheme for low-pressure, fluorescent 
tanning lamps to facilitate replacement of these lamps when they wear 
out. IEC SC 34A has responsibility for the IEC 61228 standard entitled 
``Fluorescent Ultraviolet Lamps Used for Tanning--Measurement and 
Specification Method'' (Ref. 5). At their meeting in 2003, IEC TC 61, 
MT 16 and IEC SC 34A reached a consensus position on lamp testing and 
classification. This position has now been incorporated into the IEC 
60335-2-27, Ed. 5.0 standard (Ref. 6) and the IEC 61228, Ed. 2.0 
standard (Ref. 5).
    In October 2003, FDA presented six amendments to TEPRSSC and all 
were approved with modifications to two of the proposals. These six 
amendments, along with others, are being presented in this proposed 
rule and are outlined in section II.
    In addition, FDA has informed radiological health representatives 
from the states of our intentions to amend the Sunlamp Products 
Performance Standard through semi-annual meetings with the state 
Conference of Radiation Control Program Directors. See Web site at 
http://www.crcpd.org/.
    FDA is concerned about the safety risks from UV radiation. 
Therefore, FDA is updating our requirements for sunlamp products--which 
allow for indoor exposure to UV radiation.
    FDA is undertaking three initiatives to address the risks 
associated with sunlamp products. First, in a final reclassification 
order that issued June 2, 2014 (79 FR 31205 at 31213), FDA reclassified 
sunlamp products and UV lamps intended for use in sunlamp products from 
class I to class II, and established special controls and premarket 
notification (510(k)) requirements under the medical device authorities 
of the FD&C Act. The special controls include performance testing and 
labeling requirements, including a warning that sunlamp products are 
not to be used on persons under the age of 18 years.
    Second, and simultaneously with this proposed rule, FDA is 
proposing device restrictions under section 520(e) of the FD&C Act (21 
U.S.C. 360j(e)), which authorizes FDA to issue regulations imposing 
restrictions on the sale, distribution or use of a device, if, because 
of its potentiality for harmful effects or the collateral measures 
necessary to its use, FDA determines that absent such restrictions, 
there cannot be a reasonable assurance of its safety and effectiveness. 
As explained elsewhere in this issue of the Federal Register, the 
proposed device restrictions would require that:

[[Page 79509]]

    1. Tanning facility operators permit use of sunlamp products only 
if the prospective user is age 18 or older;
    2. Tanning facility operators, upon request by the user or 
prospective user, provide a copy of the sunlamp product user manual or 
name and address of the manufacturer or distributor from who a user 
manual may be obtained;
    3. 510(k) holders assure that a user manual accompanies each 
sunlamp product and, upon request, provide a copy of the user manual to 
any tanning facility operator, user or prospective user; and
    4. Tanning facility operators obtain each prospective user's 
signature on a risk acknowledgement certification before use that 
states that they have been informed of the risks to health that may 
result from use of these devices.
    These device restrictions would primarily apply to tanning facility 
operators, and to a lesser extent, device manufacturers and 
distributors. FDA would not consider people who use their own tanning 
beds (home users) to be tanning facility operators.
    Finally, in this action, FDA is proposing amendments to the sunlamp 
products and UV lamps performance standard at Sec.  1040.20 (21 CFR 
1040.20) (last updated in 1985), which includes technical and labeling 
requirements issued under the radiological health provisions of the 
FD&C Act. FDA is taking this action to reflect current scientific 
knowledge related to sunlamp product use, harmonize it more closely 
with IEC International Standard 60335-2-27, Ed. 5.0: 2009-12, and 
strengthen the warning statement required by Sec.  1040.20(d)(1)(i) in 
accordance with the results of the study FDA conducted under section 
230 of the Food and Drug Administration Amendments Act of 2007 (Pub. L. 
110-85).

II. Contents of the Proposed Regulation

A. Overview

    This preamble will focus on the proposed changes to Sec.  1002.1 
and Sec.  1040.20, which include:
     Requiring that UV lamp manufacturers follow the same 
reporting requirements as sunlamp product manufacturers,
     Requiring that protective eyewear manufacturers maintain 
distribution records and test records relating to the UV and visible 
transmittance of the eyewear as well as requiring the submission of 
annual reports, supplemental reports, and product reports to FDA,
     Changing the content, format, and location of the required 
warning statement to make it more effective at communicating the risks 
of indoor tanning to consumers,
     Replacing the current limit on the ratio of UVC to UVB 
irradiance with an absolute limit on UVC irradiance,
     Limiting the maximum timer interval to one that would not 
exceed a maximum dose of 500 J/m\2\, weighted with the CIE Reference 
Action Spectrum for Erythema (1999),
     Adopting the IEC ``equivalency code'' system for labeling 
and measuring the strength of replacement lamps to prevent original 
lamps being replaced with more powerful lamps, which can lead to 
sunburn,
     Changing the current subjective requirement regarding the 
visible transmittance of protective eyewear to an objective, 
quantitative requirement, adopted from the IEC standard,
     Adding a cap on the amount of visible transmittance 
allowed through the protective eyewear, to protect the users' retina 
from intense visible light,
     Updating the guidelines for the required manufacturer-
recommended exposure schedule, by requiring conformity to the IEC 
standard, which is based on current science,
     Requiring that a reproduction of the warning label be 
provided in all catalogs, specification sheets, brochures, and 
consumer-directed Web pages on which sunlamp products are offered for 
sale, and
     Requiring that persons involved in significant 
modification of sunlamp products re-certify the product just as the 
manufacturer of a new product would. This requirement currently exists 
in the FDA Laser Standard (21 CFR 1040.10(i)).

B. Changes to Sec.  1002.1

    FDA proposes to amend the requirements of part 1002 as specified in 
table 1 to require that manufacturers of UV lamps intended to be used 
in sunlamp products are subject to the same record and reporting 
requirements as manufacturers of sunlamp products. When table 1 was 
first codified, it was common for the manufacturers of UV lamps to be 
the same entity that manufactured the sunlamp product. Today, the 
market has changed and there are some manufacturers that manufacture 
only UV lamps. FDA wants to ensure that all test data necessary to 
ensure compliance with Sec.  1040.20 are collected and maintained. 
Currently, manufacturers of UV lamps are required to submit only 
product reports. Under proposed Sec.  1002.1, manufacturers of UV lamps 
would also be required to submit supplemental reports and annual 
reports and to maintain test records and distribution records. In 
addition, manufacturers of protective eyewear would also need to 
maintain distribution records as well as test records demonstrating 
that the eyewear complies with applicable UV and visible transmittance 
requirements. Proposed Sec.  1002.1 would also require that 
manufacturers of protective eyewear submit annual reports, supplemental 
reports, and product reports to FDA.

C. Changes to Sec.  1040.20

1. Incorporation by Reference
    FDA proposes to incorporate certain elements of the IEC 
International Standard 60335-2-27, Ed. 5.0: 2009-12 entitled 
``Household and Similar Electrical Appliances--Safety--Part 2-27: 
Particular Requirements for Appliances for Skin Exposure to Ultraviolet 
and Infrared Radiation,'' by reference (Ref. 6). See proposed Sec.  
1040.20(a)(2). A similar approach has been used successfully with the 
FDA standard for laser products, Sec.  1040.10, see FDA Guidance, 
``Laser Products--Conformance With IEC 60825-1 and IEC 60601-2-22'' 
(Ref. 7), and FDA has proposed to incorporate by reference several 
provisions of IEC 60825-1, Ed. 2, into the laser products performance 
standard (78 FR 37723). Harmonizing the FDA standard with the current 
IEC standard would bring it up to date with current science and better 
protect consumers from the risks posed by these devices. FDA has 
representation on the IEC committee and has had significant influence 
on changes made to the IEC standard over the past decade. Working with 
this committee, which includes representatives from industry, 
government, and the medical community, has provided FDA with useful 
expertise and perspectives to which it may not otherwise have access.
    Harmonization would have benefits for sunlamp product manufacturers 
as well. Currently, many firms producing sunlamp products for sale 
within the United States and abroad have to follow both IEC and FDA 
standards. Aligning these standards would mean that such firms would 
need to comply with a single set of rules instead of two different 
ones, at least for the particular clauses which are being adopted and 
incorporated by reference.
2. Definitions
    ``Protective goggles'' would be added to the definition of 
``protective eyewear'' in proposed Sec.  1040.20(b) since this is the 
synonymous term used in the IEC standard.
    The definition of ``sunlamp product'' would be amended to make 
clear that

[[Page 79510]]

tanning beds and tanning booths are included within this term.
    We propose adding a definition for ``tanning course.'' This term is 
used in Annex DD of IEC 60335-2-27, Ed. 5.0, to aid the manufacturer in 
the development of its exposure schedule. In the context of exposure 
schedules, ``tanning course'' means the period of time over which a tan 
is developed, starting with the first short exposure and building up to 
longer exposures over time, usually requiring a period of 3 to 4 weeks. 
In an effort to ensure that a useful recommendation is provided to the 
user about maximum annual exposure, this concept is utilized in the 
exposure schedule requirements at proposed Sec.  1040.20(d)(1)(iv) and 
the example exposure schedule provided therein. FDA is uncertain how 
users might best keep track of their exposure over many weeks and 
months, and is particularly interested in comments on the best approach 
for informing users about limiting their annual exposure.
3. Performance Requirements
    Proposed Sec.  1040.20(c)(1) would set the irradiance limit for UVC 
radiation (200-290 nm) at 0.03 Watts/meter\2\ (W/m\2\) at the shortest 
recommended exposure distance from the sunlamp product. This limit is 
the same as the one in the previous version of IEC 60335-2-27 (Ed. 4.2: 
2007-04). This requirement would replace the current limit on the ratio 
of irradiance in the 200 to 260 nm wavelength range to the irradiance 
in the 260 to 320 nm wavelength range (see Sec.  1040.20(c)(1)). One of 
the comments received in response to the 1999 ANPRM recommended that 
the current ratio limit in Sec.  1040.20(c)(1) be dropped since it is 
no longer necessary, considering current low-pressure lamp technology, 
and because a limit on the UVC/UVB ratio provides less safety than an 
absolute limit on the UVC emissions from a sunlamp product. FDA agrees 
with this comment. An absolute limit on UVC (200-290 nm) irradiance 
would provide greater assurance of user safety because a ratio permits 
higher doses of UVC (as long as they correspond to higher doses in the 
260 to 320 nm range). UVC, which is not present in sunlight that 
reaches the Earth's surface, is potentially harmful to users while less 
effective for tanning than UVA or UVB. FDA has chosen not to adopt the 
limit for UVC radiation in Ed. 5.0 of IEC 60335-2-27 because this limit 
is 10 times lower than the limit in Ed. 4.2 and FDA believes that it 
would be difficult for some manufacturers to measure irradiance at this 
level. FDA is particularly interested in comments on this proposal.
    FDA proposes to change Sec.  1040.20(c)(2) by adding a dose-based 
limit similar to the one in FDA's 1986 FDA Policy Letter on Maximum 
Timer Interval and Exposure Schedule (Ref. 3) to the maximum timer 
interval requirement in paragraph (c)(2)(ii). FDA also proposes to 
remove paragraph (v) from Sec.  1040.20(c)(2).
    Proposed Sec.  1040.20(c)(2)(ii) would incorporate by reference the 
action spectrum used in figure 103 of IEC 60335-2-27, Ed. 5.0 for 
calculating the effective dose that defines the maximum timer interval. 
This method uses the internationally-accepted CIE Reference Action 
Spectrum for Erythema (Ref. 8) instead of the CIE LYTLE action spectrum 
that was defined in the 1986 FDA Policy Letter on Maximum Timer 
Interval and Exposure Schedule (Ref. 3). Since 1986, the CIE Action 
Spectrum for Erythema has been verified and accepted by research 
laboratories across the globe. As a result, it is used worldwide in the 
calculation of the UV Index.
    The 1986 FDA Policy Letter on Maximum Timer Interval and Exposure 
Schedule also recommends the use of the Parrish 1982 melanogenesis 
action spectrum, in addition to the CIE LYTLE erythema action spectrum, 
as a secondary means of calculating the maximum timer interval. As it 
has been found that the two action spectra are highly correlated, this 
calculation does not provide independent characterization data and the 
requirement is redundant. Therefore, proposed Sec.  1040.20(c)(2)(ii) 
would not require a second calculation of the maximum timer interval.
    Proposed Sec.  1040.20(c)(2)(ii) would limit the maximum timer 
interval to one that would result in a biologically-effective (also 
referred to as erythemal-effective) dose that would not exceed 500 J/
m\2\, which is approximately equivalent to the 624 J/m\2\ value 
(weighted with the CIE LYTLE action spectrum) that was specified in the 
1986 FDA Policy Letter on Maximum Timer Interval and Exposure Schedule 
(Ref. 3). Although the FDA would like to harmonize its standard as much 
as possible with the IEC standard, consumer safety is our main concern. 
Based on spectral irradiance data submitted to the Agency and on data 
presented at the 2004 Commission Internationale de l'Eclairage (CIE) 
Symposium on ``Light and Health: Non-visual effects'' (Ref. 10), FDA 
has determined that a dose of 500 J/m\2\ (weighted with the CIE 
erythemal action spectrum) provides a biologically-equivalent dose that 
is more closely matched to the current 624 J/m\2\ value than does the 
IEC dose limit of 600 J/m\2\. FDA invites comment on this proposal.
    Proposed Sec.  1040.20(c)(3) would add a requirement that the 
control enabling manual termination of radiation emission (sometimes 
referred to as the ``panic button'' or ``emergency stop'') be easily 
accessible and readily identifiable to the user. This would ensure that 
users can easily turn the sunlamp product off for any reason.
    Proposed Sec.  1040.20(c)(4)(ii) would expand application of the 
performance requirements to all protective eyewear intended to be used 
with sunlamp products, whether sold together with a sunlamp product or 
sold separately. As we have previously explained, UV wavelengths can 
cause serious eye damage, and exposure to the shorter wavelength region 
of the UV spectrum is especially dangerous. (See 42 FR 65189 at 65191, 
December 30, 1977.) Short-term risks include photokeratitis, which is 
very painful and causes temporary loss of vision, and there is also a 
risk of retinal damage from short-term or long-term exposure, which 
could cause blind spots to form in the retina. Repeated, long-term UV 
exposure increases the risk of cataracts, and there is evidence of an 
association between UV exposure and ocular melanoma (Ref. 11).
    The spectral transmittance requirements for protective eyewear are 
necessary to protect users of sunlamp products from these risks, which 
directly result from the UV radiation emitted by the sunlamp product. 
Users of sunlamp products, especially those who tan in tanning 
facilities, often use protective eyewear manufactured by an entity 
other than the manufacturer of the sunlamp product. Use of sunlamp 
products with eyewear that does not meet these requirements would 
increase the risk posed by the radiation emitted by the sunlamp product 
and undermine the protection provided by the performance standard. 
Therefore it is necessary to apply the standard to all protective 
eyewear intended to be used with sunlamp products.
    The proposal would also modify the protective eyewear transmittance 
requirements of Sec.  1040.20(c)(4)(ii) to better ensure user safety 
and achieve harmony with the IEC standard. (See clause 32.102 of IEC 
60335-2-27, Ed. 5.0.) The requirements for spectral transmittance in 
the UV range of 200-400 nm would remain the same as in the current FDA 
standard. The proposed rule would adopt the limit of 5 percent on the 
visible transmittance in the range

[[Page 79511]]

of 400-550 nm from clause 32.102 of the IEC standard. This requirement 
would provide additional safety to protect the retina from intense 
visible light. Currently, there is no such requirement included in the 
FDA standard. The proposed rule would abandon the current requirement 
that spectral transmittance shall be sufficient over the wavelength 
range greater than 400 nm to provide visibility to the user, and 
instead adopt the lower limit of 1 percent on luminous transmission 
from clause 32.102 of the IEC standard. Replacing the subjective 
standard with an objective one would make compliance easier to verify 
and improve uniformity and consistency.
4. Label Requirements
    Proposed Sec.  1040.20(d)(1)(i) would modify the warning statement 
required to appear on the label of all sunlamp products. FDA believes 
that the current warning statement is too long, not user-friendly, and 
that its content and format could be improved to more effectively 
communicate the risks of indoor tanning to users. As discussed in 
section I, FDA has been considering updating the required warning since 
1999. In 2007, Congress required FDA to conduct consumer focus group 
testing to evaluate the adequacy of sunlamp product warning labels in 
conveying certain risk information to consumers, including the risk of 
skin cancer. (See section 230 of the Food and Drug Administration 
Amendments Act of 2007, Pub. L. 110-85.) Based on its analysis of the 
consumer testing, FDA concluded that the current warning statement 
could be made more effective by changing its required language, 
formatting, and location. See the FDA Report to Congress entitled 
``Labeling Information on the Relationship Between the Use of Indoor 
Tanning Devices and Development of Skin Cancer or Other Skin Damage'' 
(Ref. 12).
    FDA would like to harmonize its standard as much as possible with 
the IEC 60335-2-27 Ed. 5.0 standard. However, based on the results of 
the focus group testing, we believe it is appropriate for some 
differences to remain between the FDA warning statement and the IEC 
warning statement, especially since the IEC warning statement provides 
only the general substance to be conveyed (since it is intended for use 
in multiple languages) and does not provide formatting specifications. 
FDA believes that the proposed warning statement would most effectively 
convey the risks of indoor tanning to users. Specifically, the label of 
each sunlamp product would have to contain a warning statement with the 
following language and format:

``DANGER--Ultraviolet Radiation (UV)

    UV can cause:

 Skin Cancer
 Skin Burns
 Premature Skin Aging such as wrinkles and age spots
 Eye Damage (both short- and long-term)

    Wear FDA-compliant protective eyewear to prevent eye damage, such 
as burns or cataracts.
    Follow the recommended exposure schedule to avoid severe skin 
burns.
    Talk to your doctor or pharmacist before tanning if you use 
medicines and/or cosmetics. Some of these products can make you more 
sensitive to skin and eye damage from UV.''
    Currently, Sec.  1040.20(d)(1)(iv) requires sunlamp product labels 
to include a recommended exposure schedule containing certain 
information. FDA proposes to add a requirement that the exposure 
schedule be developed in accordance with the specific parameters in IEC 
60335-2-27, Ed. 5.0, Annex DD, which would be incorporated by 
reference. The proposed rule provides an example of a recommended 
exposure schedule that would meet the guidelines/parameters in IEC 
60335-2-27, Ed. 5.0, Annex DD. See proposed Sec.  1040.20(d)(1)(iv). 
These parameters are different from those provided in the 1986 FDA 
Policy Letter on Maximum Timer Interval and Exposure Schedule (Ref. 3), 
and are based on current science, including recent human research 
conducted at FDA. This requirement is aimed at reducing the cumulative 
UV dose to sunlamp product users and attaining closer harmonization of 
FDA and the IEC standard.
    Proposed Sec.  1040.20(d)(1)(iv) would also require a warning to 
appear either directly above or below the exposure schedule stating 
``Skin Type I individuals (always burns, never tans) should never use 
sunlamp products.'' This warning is based on years of published 
research showing that Skin Type I individuals sunburn easily and cannot 
tan and are therefore at the greatest risk for skin cancer. By ``Skin 
Type'' we are referring to the historical Fitzpatrick skin typing 
system (Ref. 13) developed in 1975 by dermatologist Thomas Fitzpatrick 
to predict skin reactivity in phototherapy. Under this categorization 
scheme, Skin Type I is the fairest and most sensitive while Skin Type 
VI is the darkest and least sensitive to UV radiation. The Skin Types 
that are most likely to tan through the use of sunlamp products are 
Skin Types II through IV. It has been shown (Ref. 14) that Skin Types 
III and IV can attain a tan with UV doses that are similar to what is 
needed for Skin Type II. Thus, the same dose can be used to develop and 
maintain a tan for all three Skin Types. This was confirmed in clinical 
studies performed at FDA (Ref. 15). This is a change from the approach 
of the 1986 Policy Letter, which called for exposure schedules to be 
differentiated by Skin Type.
    The proposed rule would also improve user safety by adopting the 
IEC's ``equivalency code'' system for ensuring compatibility between 
sunlamp products (e.g., tanning beds and booths) and the UV lamps 
(sometimes referred to as light bulbs) that are used in them. Proposed 
Sec.  1040.20(d)(1)(vi) would require the label of all sunlamp products 
to indicate the equivalency code range of the UV lamp to be used in the 
sunlamp product. The equivalency code range would have to be determined 
in accordance with clause 22.111 and Annex CC of IEC 60335-2-27, Ed. 
5.0, which would be incorporated by reference. Proposed Sec.  
1040.20(d)(2)(ii) would require the label of each UV lamp to indicate 
its UV lamp equivalency code, as defined in Annex CC of IEC 60335-2-27, 
Ed. 5.0. In determining the ``UV code'' component of the UV lamp 
equivalency code, output would have to be measured in accordance with 
IEC 61228, Ed. 2.0, ``Fluorescent Ultraviolet Lamps used for Tanning--
Measurement and Specification Method,'' (Ref. 5) which would be 
incorporated by reference.
    FDA believes the adoption of the IEC's absolute rating system for 
replacement lamps would eliminate confusion regarding proper lamp 
replacement, facilitate the enforcement of lamp compatibility 
requirements, and improve the safety of sunlamp products. Currently, 
FDA relies on a relative system in which the lamp manufacturer has to 
provide to FDA and to users a list of lamps with which the 
manufacturer's lamp is compatible. (See Sec. Sec.  1002.10 and 
1040.20(e)(2)(iii).) As new lamp manufacturers and new lamp models 
enter the marketplace, while other manufacturers abandon old models of 
lamps or leave the marketplace, it is increasingly cumbersome to keep 
track of which lamps are compatible with the lamps originally provided 
with the sunlamp product. This can cause confusion for tanning facility 
owners, FDA, and State or local inspectors. When incorrect lamps are 
used as replacements, the erythema-effective intensity may be greater, 
resulting in burns. Therefore, FDA has decided that an absolute rating 
system is needed,

[[Page 79512]]

which would require that a code be printed on the lamp to indicate its 
erythema-effective output, and a code range be printed on the sunlamp 
product, to indicate which lamps to use with it. Another advantage of 
adopting the provisions in both of these IEC standards is that they 
provide detailed measurement specifications, which would ensure 
consistency among manufacturers.
    Proposed Sec.  1040.20(d)(3) would retain the requirement of the 
current FDA standard that the required label information must be 
legible and readily accessible to view by a sunlamp product user 
immediately prior to use. FDA provided details regarding compliance 
with this requirement in its June 25, 1985, policy letter entitled 
``Policy on Warning Label Required on Sunlamp Products'' (Ref. 2). 
Proposed Sec.  1040.20(d)(3)(i) would incorporate similar 
specifications into the rule regarding the location, spacing, and font 
of the required warning statement. The proposal specifies that the 
warning statement would have to be readily accessible to view whether 
the tanning bed canopy or tanning booth door is open or closed when the 
user approaches, which may necessitate that it appear in more than one 
location on the sunlamp product. FDA believes that these label 
specifications would ensure that users see the required warning prior 
to use, and would result in a more comprehensive and effective 
standard.
    Proposed Sec.  1040.20(d)(3)(ii) specifies that required UV lamp 
information would have to appear on the packaging of the lamp in 
addition to being permanently affixed or inscribed on the lamp itself. 
This would ensure that anyone replacing a UV lamp would be aware of the 
lamp equivalency code and required warnings before and after purchase.
    We propose revising Sec.  1040.20(d)(3)(iv) to achieve consistency 
with the requirement in the device labeling regulations at 21 CFR 
801.15(c)(1) that all words, statements, and other information required 
by or under authority of the FD&C Act to appear on the label or 
labeling of a device must appear in the English language (or a foreign 
language for articles distributed solely in Puerto Rico or in a 
Territory where the predominant language is not English). Since the 
labeling of UV lamps must comply with the labeling requirements of part 
801 and Sec.  1040.20, we propose to remove the language in Sec.  
1040.20(d)(3)(iv) that permits the manufacturer to express the 
manufacturer's name and month and year of manufacture as code or 
symbols. FDA is not aware of any request to use symbols or codes for 
this purpose in the past.
5. User Information
    The proposal would remove Sec.  1040.20(e)(1)(iv) since the 
recommended exposure schedule no longer needs to be differentiated by 
skin type and would be required to be prominently displayed at the 
beginning of the users' instructions under proposed Sec.  
1040.20(e)(1)(i).
    Proposed Sec.  1040.20(e)(1)(v) would add a requirement for the 
provision of instructions and warnings regarding assembly, operation, 
and maintenance, which is modeled on the proposed FDA Performance 
Standard for Laser Products (78 FR 37723). This would better protect 
individuals who assemble, test, and maintain sunlamp products.
    Proposed Sec.  1040.20(e)(3) would add a requirement for the 
provision of the required warning statement in all catalogs, 
specification sheets, and descriptive brochures intended for consumers 
in which sunlamp products are offered for sale, and on all consumer-
directed Web pages on which sunlamp products are offered for sale. This 
requirement would ensure that consumers are fully informed of the risks 
presented by sunlamp products at the time they consider purchasing it.
6. Test for Determination of Compliance
    Proposed Sec.  1040.20(f) would add a requirement that the 
performance requirements for the measuring instrument in clause 32.101 
of IEC 60335-2-27 Ed. 5.0 would apply.
7. Modification of Certified Sunlamp Products
    Proposed Sec.  1040.20(g) is also modeled after the proposed FDA 
Performance Standard for Laser Products (78 FR 37723). FDA believes the 
addition of these requirements, which have been used successfully over 
the past 2 decades for laser products, would improve safety by ensuring 
that modifications that affect performance would be held to the same 
standards as original manufacturing.

III. Legal Authority

    Section 532 of the FD&C Act (21 U.S.C. 360ii) authorizes FDA to 
establish and administer an electronic product radiation control 
program to protect the public health and safety. Section 534 of the 
FD&C Act gives FDA authority to issue regulations establishing 
performance standards for electronic products to control their emission 
of radiation. These standards may include requirements for product 
testing and radiation measurement, the attachment of warning signs and 
labels, and the provision of instructions for product installation, 
operation, and use. Section 1003(b)(2)(E) of the FD&C Act (21 U.S.C. 
393(b)(2)(E)) requires FDA to ensure that public health and safety are 
protected from electronic product radiation. In addition, section 
701(a) of the FD&C Act (21 U.S.C. 371(a)) authorizes the Agency to 
issue regulations for the efficient enforcement of the FD&C Act.
    Section 230 of the Food and Drug Administration Amendments Act of 
2007 (Pub. L. 110-85) directed FDA to determine whether changes to the 
warning statement would more effectively communicate the risks of 
indoor tanning, such as skin cancer, and to submit a report that 
includes an explanation of the measures being implemented to 
significantly reduce the risks associated with indoor tanning devices. 
As explained in section II, based on consumer testing, FDA determined 
that the proposed warning statement would better communicate the risks 
of indoor tanning to consumers, and is proposing these amendments to 
the sunlamp products performance standard to significantly reduce the 
risks associated with these products.

IV. Proposed Effective Date

    FDA proposes that any final rule issued based on this proposal 
become effective 1 year after the date of publication of the final rule 
in the Federal Register.

V. Environmental Impact, No Significant Impact

    The Agency has determined under 21 CFR 25.34(c) that this proposed 
action is of a type that does not individually or cumulatively have a 
significant effect on the human environment. Therefore, neither an 
environmental assessment nor an environment impact statement is 
required.

VI. Economic Analysis of Impacts

    FDA has examined the impacts of the proposed rule under Executive 
Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5 
U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 
104-4). Executive Orders 12866 and 13563 direct Agencies to assess all 
costs and benefits of available regulatory alternatives and, when 
regulation is necessary, to select regulatory approaches that maximize 
net benefits (including potential economic, environmental, public 
health and safety, and other advantages; distributive impacts; and 
equity). We have

[[Page 79513]]

developed a comprehensive Economic Analysis of Impacts that assesses 
the impacts of the proposed rule. The Agency believes that this 
proposed rule is not a significant regulatory action as defined by 
Executive Order 12866.
    The Regulatory Flexibility Act requires Agencies to analyze 
regulatory options that would minimize any significant impact of a rule 
on small entities. We do not believe this proposed rule would result in 
a significant impact on a substantial number of small entities, but the 
impacts are uncertain so we are explicitly seeking comment on the 
impacts.
    Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires 
that Agencies prepare a written statement, which includes an assessment 
of anticipated costs and benefits, before proposing ``any rule that 
includes any Federal mandate that may result in the expenditure by 
State, local, and tribal governments, in the aggregate, or by the 
private sector, of $100,000,000 or more (adjusted annually for 
inflation) in any one year.'' The current threshold after adjustment 
for inflation is $144 million, using the most current (2014) Implicit 
Price Deflator for the Gross Domestic Product. FDA does not expect this 
proposed rule to result in any 1-year expenditure that would meet or 
exceed this amount.
    The proposed rule would affect several aspects of the performance 
standards to reduce risks associated with use. The costs are summarized 
in table 1. Estimated one-time costs are $20,917 to $113,240 and annual 
costs are $4,686 to $7,230. The present discounted costs are $57,181 to 
$151,390 at 7 percent and $61,498 to $165,883 at 3 percent. Annualized 
at 7 percent over 10 years, total costs are $8,141 to $21,498. At 3 
percent, annualized total costs are $7,867 to $19,447.
    The primary benefit of the proposed rule would be from reduced 
injuries, including sunburn, photokeratitis, skin cancer, cataracts and 
ocular melanoma and from reduced exposure to UV radiation. We are 
unable to quantify the benefits, but demonstrate that they satisfy 
breakeven tests using very conservative assumptions. The benefits of 
this proposed rule would justify the costs.

         Table 1--Present Discounted Costs of the Proposed Rule
------------------------------------------------------------------------
              Year                 Low cost scenario  High cost scenario
------------------------------------------------------------------------
Discounted @7 percent...........             $57,181            $151,390
Discounted @3 percent...........              61,498             165,883
10-Year Annualized @7 percent...               8,141              21,498
10-Year Annualized @3 percent...               7,867              19,447
------------------------------------------------------------------------

    The full assessment of the economic analysis is available in Docket 
FDA-1998-N-0880 and at http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm (Ref. 16).

VII. Federalism

    FDA has analyzed this proposed rule in accordance with the 
principles set forth in Executive Order 13132. Section 4(a) of the 
Executive Order requires Agencies to ``construe * * * a Federal statute 
to preempt State law only where the statute contains an express 
preemption provision or there is some other clear evidence that the 
Congress intended preemption of State law, or where the exercise of 
State authority conflicts with the exercise of Federal authority under 
the Federal statute.'' Federal law includes an express preemption 
provision at section 542 of the FD&C Act (21 U.S.C. 360ss) that 
preempts the States from establishing, or continuing in effect, any 
standard with respect to an electronic product which is applicable to 
the same aspect of product performance as a Federal standard prescribed 
under section 534 of the FD&C Act and which is not identical to the 
Federal standard. If this proposed rule is made final, the final rule 
would prescribe a Federal standard under section 534 of the FD&C Act. 
However, section 542 of the FD&C Act does not ``prevent the Federal 
Government or the government of any State or political subdivision 
thereof from establishing a requirement with respect to emission of 
radiation from electronic products procured for its own use if such 
requirement imposes a more restrictive standard than that required to 
comply with the otherwise applicable Federal standard.'' (Section 542 
of the FD&C Act.)

VIII. Paperwork Reduction Act of 1995

    This proposed rule contains information collection provisions that 
are subject to review by OMB under the Paperwork Reduction Act of 1995 
(44 U.S.C. 3501-3520). A description of these provisions is given in 
the paragraphs that follow with an estimate of the annual reporting, 
recordkeeping, and third-party disclosure burden. Included in the 
estimate is the time for reviewing instructions, searching existing 
data sources, gathering and maintaining the data needed, and completing 
and reviewing each collection of information.
    FDA invites comments on these topics: (1) Whether the proposed 
collection of information is necessary for the proper performance of 
FDA's functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.
    Title: Sunlamp Products; Proposed Amendment to Sec.  1002.1 (Record 
and Reporting Requirements) and Sec.  1040.20 (Performance Standard).
    Description: The Safe Medical Devices Act of 1990 (Pub. L. 101-629) 
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 (42 U.S.C. 201 et seq.) to Chapter V, subchapter C of the 
FD&C Act (21 U.S.C. 301 et seq.). Under the FD&C Act, FDA administers 
an electronic product radiation control program to protect the public 
health and safety. FDA also develops and administers radiation safety 
performance standards for electronic products, including sunlamp 
products.
    Current Sec.  1002.1 requires that sunlamp product manufacturers 
submit product reports, supplemental reports, and annual reports and 
requires that test records and distribution records are maintained, 
used for summary data submitted in the annual report, and made 
available upon request. In addition, current Sec.  1002.1 requires UV

[[Page 79514]]

lamp manufacturers to submit product reports. Proposed Sec.  1002.1 
would require that manufacturers of UV lamps also submit supplemental 
reports and annual reports and maintain test records and distribution 
records.
    Proposed Sec.  1002.1 would also require that manufacturers of 
protective eyewear maintain test records and distribution records as 
well as submit annual reports, supplemental reports, and product 
reports. The eyewear must meet certain transmittance limits in the UV 
and visible wavelength range. Both manufacturers of sunlamp products 
that include eyewear with their products and manufacturers of 
protective eyewear that is sold separately would be responsible for 
maintaining records of the results yielded by the testing and reporting 
these results to FDA. (See Sec.  1002.1.) There are no operating and 
maintenance costs associated with testing the eyewear because this 
requirement reflects current market practices.
    Proposed Sec.  1040.20(d)(2)(ii) would require that the UV lamp 
labeling include a replacement lamp code instead of a list of 
compatible replacement lamps. Although the single UV lamp manufacturer 
in the United States is already required to conduct spectral irradiance 
testing of lamps in order to demonstrate compatibility with other model 
lamps (whether made by that company or other manufacturers), proposed 
Sec.  1040.20(d)(2)(ii) would require testing in accordance with test 
methods as specified in IEC 61228, Ed. 2.0, ``Fluorescent Ultraviolet 
Lamps Used for Tanning--Measurement and Specification Method.'' The 
spectral irradiance data obtained is used to calculate the UV code that 
would be required to be printed on the lamp by proposed Sec.  
1040.20(d)(2)(ii). Manufacturers would be responsible for maintaining 
and reporting records of the results yielded by the testing as well as 
imprinting the lamp with the replacement lamp code.
    Proposed Sec.  1040.20(d)(2)(iii) would require that each UV lamp 
have a label containing the model identification of the lamp, if 
applicable. Manufacturers would be responsible for printing the model 
number on the lamp itself.
    Proposed Sec.  1040.20(d)(3)(iii) would permit the manufacturer of 
the sunlamp product or UV lamp to submit a request to the Director, 
Office of In Vitro Diagnostics and Radiological Health, Center for 
Devices and Radiological Health for an approval of alternate labeling 
if the size, configuration, design, or function of the sunlamp product 
or UV lamp would preclude compliance with the requirements for any 
required label or would render the required wording of such label 
inappropriate or ineffective. In these circumstances, manufacturers 
would be responsible for reporting the request to FDA. The operating 
and maintenance costs associated with this provision are based on 
correspondence costs (postage) for non-email communications.
    Proposed Sec.  1040.20(d)(3)(iv) would permit manufacturers of UV 
lamps to permanently affix or inscribe the tags or labels required by 
Sec. Sec.  1010.2(b) and 1010.3(a) on the lamp packaging associated 
with the UV lamps, rather than the UV lamps themselves. The third party 
disclosure burden of this provision would be the time it takes to 
inscribe the label or tag on the UV lamp packaging.
    Proposed Sec.  1040.20(e)(1)(v) would require instructions for 
sunlamp ``assembly, operation, and maintenance,'' and would include a 
schedule of maintenance. This information would also protect those 
maintaining and assembling sunlamp products from inadvertent exposure 
to UV radiation by providing adequate instructions to avoid UV exposure 
during assembly or maintenance. We presume that the maintenance 
schedules would be developed from known information about how to 
properly maintain these devices. The third party disclosure burden of 
this provision would be the time spent bringing this known information 
into a user-friendly format and disclosing it to users. We also assume 
that this information would be identical for all units of a given model 
of sunlamp products.
    Proposed Sec.  1040.20(g) would require that those who change the 
function or performance characteristics of a sunlamp are manufacturers 
and would need to recertify and re-identify the device. This 
requirement applies only if the modification affects any aspect of the 
product's performance or intended function(s) for which Sec.  1040.20 
has an applicable requirement. We believe some sunlamp owners (e.g., 
tanning facility owners) view such modifications as a less expensive 
alternative to purchasing a new sunlamp product. We believe some 
owners, otherwise inclined to alter their sunlamp's performance 
characteristics, would be deterred from doing so by our proposal 
because recertification would cost a tanning facility owner more than 
$30,000 in operating and maintenance costs since tanning facility 
owners do not typically have the equipment necessary to recertify 
sunlamp products. However, if a tanning facility owner chooses to 
recertify the sunlamp product, documentation must be submitted to FDA.
    Description of Respondents: Respondents for these information 
collections are manufacturers of sunlamp products and UV lamps intended 
for use in sunlamp products, and manufacturers of protective eyewear 
that is intended to be used with sunlamp products.
    FDA estimates the burden of this collection of information as 
follows:

                                                       Table 2--Estimated Annual Reporting Burden
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                            Capital and
                                            Number of       Number of     Total annual   Average burden                                    operating and
             21 CFR section                respondents    responses per     responses     per response             Total hours              maintenance
                                                           respondent                                                                          costs
--------------------------------------------------------------------------------------------------------------------------------------------------------
1002.1(b)--Lamp only...................               1               9               9               2  18.............................  ..............
1002.1(b)--Protective eyewear..........               5               4              20             0.5  10.............................  ..............
1040.20(d)(2)(ii)......................               1               1               1               1  1..............................  ..............
1040.20(d)(3)(iii).....................               1               1               1             .17  .17 (10 minutes)...............  ..............
1040.20(g).............................               1               1               1               8  8..............................         $43,000
                                        ----------------------------------------------------------------------------------------------------------------
    Total..............................  ..............  ..............  ..............  ..............  37.............................         $43,000
--------------------------------------------------------------------------------------------------------------------------------------------------------


[[Page 79515]]


                                                     Table 3--Estimated Annual Recordkeeping Burden
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                            Capital and
                                            Number of       Number of     Total annual   Average burden                                    operating and
             21 CFR section               recordkeepers    records per       records           per                 Total hours              maintenance
                                                          recordkeeper                    recordkeeping                                        costs
--------------------------------------------------------------------------------------------------------------------------------------------------------
1002.1(b)--Lamp only...................               1               2               2             2.5  5..............................
1002.1(b)--Protective eyewear..........               5               3              15               7  105............................
1040.20(d)(2)(ii)......................               1              75              75             0.8  60.............................         $30,000
                                        ----------------------------------------------------------------------------------------------------------------
    Total..............................  ..............  ..............  ..............  ..............  170............................         $30,000
--------------------------------------------------------------------------------------------------------------------------------------------------------


                           Table 4--Estimated Annual Third Party Disclosure Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of
         21 CFR section              Number of      disclosures    Total annual   Average burden    Total hours
                                    respondents   per respondent    disclosures   per disclosure
----------------------------------------------------------------------------------------------------------------
1040.20(d)(1)(vi)...............               5           5,200          26,000           .0034              88
1040.20(d)(2)(ii)...............               1         286,000         286,000           .0017             486
1040.20(d)(2)(iii)..............               1         286,000         286,000           .0017             486
1040.20(d)(3)(ii)...............               1         286,000         286,000           .0017             486
1040.20(d)(3)(iv)...............               1          23,833          23,833           .0017              41
1040.20(e)(1)(v)................               5              10              50              12             600
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............           2,187
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

A. Reporting Burden

    For Sec.  1002.1(b)--Lamp only, we estimate the single U.S.-based 
manufacturer of UV lamps would need to submit 2 new types of reports 
(supplemental reports and an annual report) for the 75 models. Based on 
previous submissions, we estimate that nine supplemental reports would 
be submitted per year. Annual reports are submitted once per year. We 
estimate that it takes approximately 2 hours to complete each report 
for a total of 18 burden hours.
    For Sec.  1002.1(b)--Protective eyewear, we estimate that the five 
respondents would need to report the information annually and that each 
of the manufacturers produces two models of protective eyewear. 
Manufacturers are not required to produce two types of eyewear; 
however, FDA estimates that each of the five respondents produces two 
types of eyewear that could be made available with sunlamp products. 
Manufacturers would fill out and submit the annual, supplemental, and 
product reports demonstrating conformance to the performance standard, 
and this process is estimated to take 30 minutes per report for a total 
of 10 hours.
    For Sec.  1040.20(d)(2)(ii), we estimate that the single U.S.-based 
manufacturer of UV lamps would test 75 UV lamps and that the time 
needed to incorporate the data into the product report is 1 hour.
    For Sec.  1040.20(d)(3)(iii), we estimate that one sunlamp product 
and UV lamp manufacturer would submit a request for alternate labeling 
approval to FDA. This task is expected to be performed by clerical 
staff that prepare the request and submit it to FDA. This process is 
expected to take 10 minutes (.17 hours) to type the request and email 
it. The request is expected to be submitted electronically and does not 
involve any operating and maintenance cost.
    For Sec.  1040.20(g), we estimate that, at most, one respondent per 
year would decide to re-certify a sunlamp product with the Agency, 
instead of the less expensive alternative of purchasing a new sunlamp 
product. The $43,000 capital costs for recertifying the sunlamp product 
includes the required instrumentation and calibration light sources 
such as a double-grating spectroradiometer with integrating sphere and 
software. We estimate the time needed to make the necessary spectral 
measurements and compile them into a report that would be sent to FDA 
to take 8 hours.

B. Recordkeeping Burden

    For Sec.  1002.1(b)--Lamp only, we estimate the single U.S.-based 
manufacturer of UV lamps would need to maintain 2 types of records 
(test records and distribution records) for each of the 75 models and 
that it takes approximately 2 minutes per model per record for a total 
of 300 minutes, or 5 burden hours.
    For Sec.  1002.1(b)--Protective eyewear, we estimate that there are 
five U.S. manufacturers of protective eyewear that would be affected by 
this amendment. However, this number is uncertain and we welcome 
comment on this issue. We estimate that each of the manufacturers 
produces 2 models of protective eyewear and the manufacturer would 
sample approximately 10 units per model. The time required to perform 
the necessary testing, including time to verify the instrument, set up 
the test and prepare and file a report takes approximately 7 hours per 
model. Protective eyewear manufacturers would also be required to 
maintain distribution records for their products. We estimate that 7 
hours per year would be necessary for the manufacturer to log and file 
the distribution data. We estimate a total of 105 hours for each 
manufacturer to maintain the single distribution record for both models 
of protective eyewear as well as perform the testing for the individual 
test records that are to be maintained for each model of protective 
eyewear.
    For Sec.  1040.20(d)(2)(ii), we expect that the single U.S.-based 
lamp manufacturer does not use IEC UV codes and would have to test and 
label its models under the proposed rule. The manufacturer has an 
estimated 30 to 120 models and we chose the mean number of models (75) 
for our calculations. The mean cost of testing each model is $350 and 
the cost for an ink stamp is $50 per model,

[[Page 79516]]

yielding an approximate $30,000 in operating and maintenance cost for 
Sec.  1040.20(d)(2)(ii). Manufacturers are already performing similar 
spectral irradiance testing to determine lamp compatibility. We 
estimate that it would take 0.8 hours per model to modify the test 
setup to measure spectral irradiance in order to determine the UV code 
as well as file the results, for a total of 60 hours. We estimate that 
the single U.S.-based lamp manufacturer is already maintaining records 
of these tests, so there should be no additional cost associated with 
proposed Sec.  1002.1 that requires lamp manufacturers now also to 
maintain test records, although FDA is seeking comment on this 
understanding.

C. Third Party Disclosure Burden

    For Sec.  1040.20(d)(1)(vi), we estimate that the five respondents 
would need to list the code range that can be used in each of the 5,200 
sunlamp products produced annually. We estimate 2 minutes to print and 
affix this label on each the 26,000 sunlamp products, for a total of 88 
hours.
    For Sec.  1040.20(d)(2)(ii), the single U.S.-based lamp 
manufacturer would need to inscribe the UV lamp equivalency code onto 
each lamp. We estimate it would take 1 minute to ink stamp 10 lamps 
with the new UV lamp equivalency code. The operating and maintenance 
costs for this information collection are subsumed in the recordkeeping 
burden estimate for Sec.  1040.20(d)(2)(ii). The lamp manufacturer 
produces 286,000 new lamps per year so this process is expected to take 
approximately 28,600 minutes per year, or about 486 hours.
    For Sec.  1040.20(d)(2)(iii), the single U.S.-based lamp 
manufacturer would need to inscribe the model identification onto each 
lamp. We estimate it would take 1 minute to ink stamp ten lamps with 
the model identifier. The operating and maintenance costs for this 
information collection are subsumed in the recordkeeping burden 
estimate for Sec.  1040.20(d)(2)(ii). The lamp manufacturer produces 
286,000 new lamps per year so this process is expected to take 
approximately 28,600 minutes per year, or about 486 hours.
    For Sec.  1040.20(d)(3)(iv), we estimate that the single U.S.-based 
lamp manufacturer would permanently affix or inscribe the tags or 
labels required by Sec. Sec.  1010.2(b) and 1010.3(a) on the packaging 
of all the UV lamps rather than the lamps themselves. Since lamps are 
typically packaged and sold in cases of 12, this yields 23,833 packages 
that must bear the third party disclosure required by Sec.  
1040.20(d)(3)(iv). We estimate it would take 1 minute to ink stamp 10 
lamp packages with the tags or labels required by Sec. Sec.  1010.2(b) 
and 1010.3(a) for a total of 41 hours.
    For Sec.  1040.20(d)(3)(ii), the single U.S.-based lamp 
manufacturer would need to inscribe or affix the UV lamp equivalency 
code on the packaging of each lamp. We estimate it would take 1 minute 
to ink stamp 10 lamp packages with the new UV lamp equivalency code. 
The lamp manufacturer produces 286,000 new lamps per year so this 
process is expected to take 28,600 minutes per year, or about 486 
hours.
    For Sec.  1040.20(e)(1)(v), we estimate the 5 respondents would 
need to go through this reporting exercise once for each of their 10 
models of sunlamp products. We estimate that 10 hours of a technician's 
time would be required to collect all the necessary information 
regarding maintenance and assembly and 2 hours of a manager's time to 
review this information once it is re-formatted into the user 
instructions. Thus, we estimate a total of 12 hours per model of 
sunlamp product would be required for a total of 600 hours. This would 
be a one-time cost.
    This proposed rule also refers to previously approved collections 
of information found in FDA regulations. These collections of 
information are subject to review by OMB under the PRA. The collections 
of information found in proposed Sec.  1040.20(d)(1)(ii); (d)(1)(iii); 
(d)(1)(iv), 1st sentence; (d)(1)(v); (e)(1)(i) to (e)(1)(iv); 
(e)(2)(i), and (e)(2)(ii) have been approved under OMB control number 
0910-0025 (expires January 1, 2017); the collections of information 
found in Sec.  1040.20(d)(3)(v) have been approved under OMB control 
number 0910-0485 (expires February 28, 2015).
    In addition, FDA concludes that proposed Sec.  1040.20(d)(1)(i); 
(d)(1)(iv), 2nd and 3rd sentences; (d)(2)(i); (d)(2)(iv); (d)(3)(i); 
and (e)(3) do not constitute ``collection[s] of information'' under the 
PRA. Rather, the labeling statements are ``public disclosure[s] of 
information originally supplied by the Federal government to the 
recipient for the purpose of disclosure to the public.'' (5 CFR 
1320.3(c)(2).)
    To ensure that comments on information collection are received, OMB 
recommends that written comments be faxed to the Office of Information 
and Regulatory Affairs, OMB (see ADDRESSES). All comments should be 
identified with the title ``Sunlamp Products; Proposed Amendment to 
Sec.  1002.1 (Record and Reporting Requirements) and Sec.  1040.20 
(Performance Standard).''
    In compliance with the PRA (44 U.S.C. 3407(d)), the Agency has 
submitted the information collection provisions of this proposed rule 
to OMB for review. These requirements will not be effective until FDA 
obtains OMB approval. FDA will publish a notice concerning OMB approval 
of these requirements in the Federal Register.

IX. Incorporation by Reference

    FDA is proposing to incorporate by reference certain portions of 
the IEC International Standards 60335-2-27, Ed. 5.0: 2009-12 entitled 
``Household and Similar Electrical Appliances--Safety--Part 2-27: 
Particular Requirements for Appliances for Skin Exposure to Ultraviolet 
and Infrared Radiation''; and 61228, Ed. 2.0, ``Fluorescent Ultraviolet 
Lamps Used for Tanning--Measurement and Specification Method.'' You may 
purchase a copy of these materials from the International 
Electrotechnical Commission (EC Central Office), 3 rue de Varembe, CH-
1211 Geneva 20, Switzerland, call +41 22-919-02-11, https://webstore.iec.ch/. FDA is also proposing to incorporate by reference the 
American National Standard C81.10-1976, entitled ``Specifications for 
Electric Lamp Bases and Holders--Screw-Shell Types.'' You may purchase 
a copy of the material from the American National Standards Institute, 
1889 L St. NW., 11th Floor, Washington, DC 20036, call 202-293-8020, 
www.ansi.org.
    The IEC 60335 standard describes technical specifications that 
address the safety of electrical appliances that incorporate emitters 
for exposing the skin to UV and infrared radiation, including those 
found in tanning salons or other facilities. The IEC 61228 standard 
describes the method to measure, evaluate, and specify the 
characteristics of fluorescent UV lamps that are used in appliances for 
tanning purposes. The ANSI standard describes technical specifications 
that will help ensure only appropriate bulbs can be fitted to the 
appliance.

X. Comments

    Interested persons may submit either electronic comments regarding 
this document to http://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). FDA is explicitly 
seeking comment on how the proposed requirements would impact small 
entities.
    Comments on the following two proposals listed are of special 
interest to FDA:
    1. The Use of the Limit on UVC Irradiance of 0.03 W/cm\2\ in IEC 
60335-

[[Page 79517]]

2-27, Ed. 4.2: 2007-4 Instead of the Limit of 0.003 W/cm\2\ in IEC 
60335-2-27, Ed. 5.0: 2009-12.
    2. The Use of a Limit of 500 J/m\2\ on the Maximum Dose Used to 
Calculate the Maximum Timer Limit, Instead of the 600 J/m\2\ Limit in 
IEC 60335-2-27, Ed. 5.0: 2009-12.

XI. References

    The following references are on display in the Division of Dockets 
Management (see ADDRESSES) and are available for viewing by interested 
persons between 9 a.m. and 4 p.m., Monday through Friday; they are also 
available electronically at http://www.regulations.gov. FDA has 
verified the Web site addresses, as of the date this document publishes 
in the Federal Register, but Web sites are subject to change over time.

1. Boniol, M., P. Autier, P. Boyle, and S. Gandini, ``Cutaneous 
Melanoma Attributable to Sunbed Use: Systematic Review and Meta-
analysis,'' British Medical Journal, 345:e8503, December 2012.
2. FDA, Policy on Warning Label Required on Sunlamp Products, 
Department of Health and Human Services, Center for Devices and 
Radiological Health, Rockville, MD, June 25, 1985, http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM095333.pdf.
3. FDA, Policy on Maximum Timer Intervals and Exposure Schedule for 
Sunlamps, Department of Health and Human Services, Center for 
Devices and Radiological Health, Rockville, MD, August 21, 1986, 
http://www.fda.gov/downloads/Radiation-EmittingProducts/RadiationEmittingProductsandProcedures/HomeBusinessandEntertainment/UCM192707.pdf.
4. FDA, Policy on Lamp Compatibility, Department of Health and Human 
Services, Center for Devices and Radiological Health, Rockville, MD, 
September 2, 1986, http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM095325.pdf.
5. IEC 61228, Ed. 2.0, ``Fluorescent Ultraviolet Lamps Used for 
Tanning--Measurement and Specification Method,'' IEC, Geneva, 
Switzerland.
6. IEC 60335-2-27, Ed. 5.0, ``Household and Similar Electrical 
Appliances--Safety--Part 2-27: Particular Requirements for 
Appliances for Skin Exposure to Ultraviolet and Infrared 
Radiation,'' IEC, Geneva, Switzerland, 2009.
7. FDA Guidance for Industry and FDA Staff, ``Laser Products--
Conformance With IEC 60825-1 and IEC 60601-2-22 (Laser Notice No. 
50),'' June 24, 2007, available at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm094366.pdf.
8. CIE S 007/E-1998/ISO 17166: 1999(E) Erythemal Reference Action 
Spectrum and Standard Erythema Dose, CIE Vienna, Austria.
9. ``Sunscreen Drug Products for Over-the-Counter Human Use; Final 
Monograph,'' FDA, Department of Health and Human Services, 64 FR 
27666, May 21, 1999.
10. Dowdy, J.C. and R.M. Sayre, ``Comparison of IEC and U.S. FDA 
Sunlamp Standards: Critical Discrepancies in Exposure Timers and 
Annual Exposure Limits,'' Proceedings of the CIE Symposium 2004 on 
Light and Health: Non-Visual Effects, Vienna, Austria, pp. 183-188.
11. Vajdic, C.M., A. Kricker, M. Giblin, et al, ``Sun Exposure 
Predicts Risk of Ocular Melanoma in Australia,'' International 
Journal of Cancer, 101(2): 175-182, September 2002.
12. FDA, ``Report to Congress: Labeling Information on the 
Relationship Between the Use of Indoor Tanning Devices and 
Development of Skin Cancer or Other Skin Damage,'' submitted 
December 2008, available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/MedicalDeviceUserFeeandModernizationActMDUFMA/ucm109288.htm.
13. Fitzpatrick, T.B., ``The Validity and Practicality of Sun-
Reactive Skin Type I Through VI,'' Archives of Dermatology, 124: 
869-871, 1988.
14. Pathak, M.A. and D.L. Fanselow, ``Photobiology of Melanin 
Pigmentation: Dose/Response of Skin to Sunlight and its Contents,'' 
Journal of the American Academy of Dermatology, 9: 724-733, 1983.
15. Miller, S.A., S.G. Coelho, S.W. Miller, et al., ``Evidence for a 
New Paradigm for UV Exposure: A Universal Schedule That is Skin 
Phototype-Independent,'' Photoderm Photoimm Photomed, 28: 187-195, 
2012.
16. http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm.

List of Subjects

21 CFR Part 1002

    Electronic products, Radiation protection, Reporting and 
recordkeeping requirements.

21 CFR Part 1040

    Electronic products, Incorporation by reference, Labeling, Lasers, 
Medical devices, Radiation protection, Reporting and recordkeeping 
requirements.
    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, it is 
proposed that 21 CFR parts 1002 and 1040 be amended as follows:

PART 1002--RECORDS AND REPORTS

0
1. The authority citation for part 1002 is revised to read as follows:

    Authority: 21 U.S.C. 352, 360, 360i, 360j, 360hh-360ss, 371, 
374, 393.

0
2. Section 1002.1 is amended by revising Table 1 to read as follows:


Sec.  1002.1  Applicability.

* * * * *

                                                  Table 1--Record and Reporting Requirements by Product
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                              Manufacturer                                                                  Dealer and
-----------------------------------------------------------------------------------------------------------------------------------------   distributor
                                                                                                                                         ---------------
                                               Product                                                                                     Distribution
                                            reports Sec.   Supplemental     Abbreviated       Annual       Test records    Distribution    records Sec.
                 Products                       1002.10    reports Sec.    reports Sec.    reports Sec.        Sec.        records Sec.   Sec.   1002.40
                                                              1002.11         1002.12         1002.13     1002.30(a) \1\  1002.30(b) \2\    and 1002.41
 
--------------------------------------------------------------------------------------------------------------------------------------------------------
DIAGNOSTIC X-RAY \3\ (Sec.  Sec.
 1020.30, 1020.31, 1020.32, and 1020.33):
    Computed tomography...................            X               X   ..............              X               X               X               X
    X-ray system \4\......................            X               X   ..............              X               X               X               X
    Tube housing assembly.................            X               X   ..............              X               X               X
    X-ray control.........................            X               X   ..............              X               X               X               X
    X-ray high voltage generator..........            X               X   ..............              X               X               X               X
    X-ray table or cradle.................  ............  ..............              X   ..............              X               X               X
    X-ray film changer....................  ............  ..............              X   ..............              X               X

[[Page 79518]]

 
    Vertical cassette holders mounted in a  ............  ..............              X   ..............              X               X               X
     fixed location and cassette holders
     with front panels....................
    Beam-limiting devices.................            X               X   ..............              X               X               X               X
    Spot-film devices and image                       X               X   ..............              X               X               X               X
     intensifiers manufactured after April
     26, 1977.............................
    Cephalometric devices manufactured      ............  ..............              X   ..............              X               X   ..............
     after February 25, 1978..............
    Image receptor support devices for      ............  ..............              X   ..............              X               X               X
     mammographic X-ray systems
     manufactured after September 5, 1978.
CABINET X RAY (Sec.   1020.40):
    Baggage inspection....................            X               X   ..............              X               X               X               X
    Other.................................            X               X   ..............              X               X               X   ..............
PRODUCTS INTENDED TO PRODUCE PARTICULATE
 RADIATION OR X-RAYS OTHER THAN DIAGNOSTIC
 OR CABINET DIAGNOSTIC X-RAY:
    Medical...............................  ............  ..............              X               X               X               X   ..............
    Analytical............................  ............  ..............              X               X               X               X   ..............
    Industrial............................  ............  ..............              X               X               X               X   ..............
TELEVISION PRODUCTS (Sec.   1020.10):
    <25 kilovolt (kV) and <0.1              ............  ..............              X           X \6\   ..............  ..............  ..............
     milliroentgen per hour (mR/hr IRLC 5
     6....................................
    >=25kV and <0.1mR/hr IRLC \5\.........            X               X   ..............              X   ..............  ..............  ..............
    >=0.1mR/hr IRLC \5\...................            X               X   ..............              X               X               X   ..............
MICROWAVE/RF:
    MW ovens (Sec.   1030.10).............            X               X   ..............              X               X               X   ..............
    MW diathermy..........................  ............  ..............              X   ..............  ..............  ..............  ..............
    MW heating, drying, security systems..  ............  ..............              X   ..............  ..............  ..............  ..............
    RF sealers, electromagnetic induction   ............  ..............              X   ..............  ..............  ..............  ..............
     and heating equipment, dielectric
     heaters (2-500 megahertz)............
OPTICAL:
    Phototherapy products.................            X               X   ..............  ..............  ..............  ..............  ..............
    Laser products (Sec.  Sec.   1040.10    ............  ..............  ..............  ..............  ..............  ..............  ..............
     and 1040.11).........................
    Class I lasers and products containing            X   ..............  ..............              X               X   ..............  ..............
     such lasers \7\......................
    Class I laser products containing                 X   ..............  ..............              X               X               X   ..............
     class IIa, II, IIIa, lasers \7\......
    Class IIa, II, IIIa lasers and                    X               X   ..............              X               X               X               X
     products other than class I products
     containing such lasers \7\...........
    Class IIIb and IV lasers and products             X               X   ..............              X               X               X               X
     containing such lasers \7\...........
    Sunlamp products (Sec.   1040.20).....
    Lamps only............................            X               X   ..............              X               X               X   ..............
    Sunlamp products......................            X               X   ..............              X               X               X               X
    Protective eyewear....................            X               X   ..............              X               X               X   ..............

[[Page 79519]]

 
    Mercury vapor lamps (Sec.   1040.30)..  ............  ..............  ..............  ..............  ..............  ..............  ..............
    T lamps...............................            X               X   ..............              X   ..............  ..............  ..............
    R lamps...............................  ............  ..............              X   ..............  ..............  ..............  ..............
ACOUSTIC:
    Ultrasonic therapy (Sec.   1050.10)...            X               X   ..............              X               X               X               X
    Diagnostic ultrasound.................  ............  ..............              X   ..............  ..............  ..............  ..............
    Medical ultrasound other than therapy             X               X   ..............  ..............  ..............  ..............  ..............
     or diagnostic........................
    Nonmedical ultrasound.................  ............  ..............              X   ..............  ..............  ..............  ..............
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ However, authority to inspect all appropriate documents supporting the adequacy of a manufacturer's compliance testing program is retained.
\2\ The requirement includes Sec.  Sec.   1002.31 and 1002.42, if applicable.
\3\ Report of Assembly (Form FDA 2579) is required for diagnostic x-ray components; see Sec.   1020.30(d)(1) through (d)(3).
\4\ Systems records and reports are required if a manufacturer exercises the option and certifies the system as permitted in Sec.   1020.30(c).
\5\ Determined using the isoexposure rate limit curve (IRLC) under phase III test conditions (Sec.   1020.10(c)(3)(iii)).
\6\ Annual report is for production status information only.
\7\ Determination of the applicable reporting category for a laser product hall be based on the worst-case hazard present within the laser product.

PART 1040--PERFORMANCE STANDARDS FOR LIGHT-EMITTING PRODUCTS

0
1. The authority citation for 21 CFR part 1040 is revised to read as 
follows:

    Authority: 21 U.S.C. 351, 352, 360, 360e-360j, 360hh-360ss, 371, 
381, 393.

0
2. Section 1040.20 is revised to read as follows:


Sec.  1040.20  Sunlamp products and ultraviolet lamps intended for use 
in sunlamp products.

    (a) Applicability. The provisions of this section, as amended, are 
applicable as specified to all sunlamp products and ultraviolet lamps 
intended for use in sunlamp products not later than [A DATE WILL BE 
ADDED 1 YEAR AFTER DATE OF PUBLICATION OF A FUTURE FINAL RULE IN THE 
Federal Register].
    (b) Definitions. As used in this section, the following definitions 
apply:
    Exposure position means any position, distance, orientation, or 
location relative to the radiating surfaces of the sunlamp product at 
which the user is intended to be exposed to ultraviolet radiation from 
the sunlamp product, as recommended by the manufacturer.
    Irradiance means the radiant power incident on a surface at a 
specified location and orientation relative to the radiating surface 
divided by the area of the surface, as the area becomes vanishingly 
small, expressed in units of watts per square centimeter (W/cm\2\).
    Maximum exposure time (Te) means the greatest continuous exposure 
time interval recommended by the manufacturer of the sunlamp product.
    Maximum timer interval means the greatest time interval setting on 
the timer of a sunlamp product.
    Protective eyewear or protective goggles means any device designed 
to be worn by users of a sunlamp product to reduce exposure of the eyes 
to radiation emitted by the product.
    Spectral irradiance (E[lambda]) means the irradiance 
resulting from radiation within a wavelength range divided by the 
wavelength range as the range becomes vanishingly small, expressed in 
units of watts per square centimeter per nanometer (W/(cm\2\/nm)).
    Spectral transmittance (T[lambda]) means the spectral 
irradiance transmitted through protective eyewear divided by the 
spectral irradiance incident on the protective eyewear.
    Sunlamp product means any device designed to incorporate one or 
more ultraviolet lamps intended for irradiation of any part of the 
living human body, by ultraviolet radiation with wavelengths in air 
between 200 and 400 nanometers, to induce skin tanning. This definition 
includes tanning beds and tanning booths.
    Tanning course means a consecutive series of tanning exposures 
until a tan is developed, usually spanning a period of 3 to 4 weeks.
    Timer means any device incorporated into a sunlamp product that 
terminates radiation emission after a preset time interval.
    Ultraviolet lamp means any lamp that produces ultraviolet radiation 
in the wavelength interval of 200 to 400 nanometers in air and that is 
intended for use in any sunlamp product.
    (c) Performance requirements--(1) UVC (200-290 nm) irradiance. The 
total irradiance emitted by a sunlamp product in the wavelength range 
between 200 and 290 nm (UVC) shall not exceed 0.03 W/m\2\. UVC 
irradiance shall be measured at the shortest exposure distance 
recommended by the manufacturer, as required to be provided on the 
label of the sunlamp product by paragraph (d)(1)(ii) of this section. 
UVC irradiance shall be calculated using the following formula:
[GRAPHIC] [TIFF OMITTED] TP22DE15.001

Where:

E is the total irradiance over the wavelength range of interest
E[lambda] is the spectral irradiance in W/(m\2\-nm)
[Delta][lambda] is the wavelength interval (nm).
The wavelength interval shall be 1 nm or less.

    (2) Timer system. (i) Each sunlamp product shall incorporate a 
timer system with multiple timer settings adequate for the recommended 
exposure time intervals for different exposure positions and expected 
results of the products as specified in the label information required 
by paragraph (e) of this section.
    (ii) The maximum timer interval may not exceed the manufacturer's 
recommended maximum exposure time

[[Page 79520]]

(Te) that is indicated on the label, as required by paragraph 
(d)(1)(iv) of this section. In addition, the maximum timer interval 
shall not result in a biologically-effective dose that exceeds 500 J/
m\2\, weighted with the erythema action spectrum provided in figure 103 
of IEC 60335-2-27, Ed. 5.0, which is incorporated by reference. The 
manufacturer's recommended maximum exposure time (Te) shall be 
determined using the following formula:
[GRAPHIC] [TIFF OMITTED] TP22DE15.002

Where:

S[lambda] is the erythema action spectrum in figure 103 
of IEC 60335-2-27, Ed. 5.0
E[lambda] is the spectral irradiance in W/(m\2\-nm)
[Delta][lambda] is the wavelength interval (nm).
The wavelength interval shall be 1 nm or less.

    (iii) No timer interval may have an error greater than 10 percent 
of the maximum timer interval of the sunlamp product.
    (iv) The timer may not automatically reset and cause radiation 
emission to resume for a period greater than the unused portion of the 
timer cycle, when emission from the sunlamp product has been 
prematurely terminated.
    (3) Control for termination of radiation emission. Each sunlamp 
product shall incorporate a control on the product to enable the person 
being exposed to manually terminate radiation emission from the product 
at any time without disconnecting the electrical plug or removing the 
ultraviolet lamp. This control shall be easily accessible to the user 
and be readily identified by touch and sight.
    (4) Protective eyewear. (i) Each sunlamp product shall be 
accompanied by the number of sets of protective eyewear that is equal 
to the maximum number of persons that the instructions provided under 
paragraph (e)(1)(ii) of this section recommend to be exposed 
simultaneously to radiation from such product.
    (ii) The spectral transmittance to the eye of all protective 
eyewear intended to be used with the sunlamp product shall not exceed a 
value of 0.001 over the wavelength range of greater than 200 nm through 
320 nm, shall not exceed a value of 0.01 over the wavelength range of 
greater than 320 nm through 400 nm, and shall not exceed a value of 
0.05 over the wavelength range of greater than 400 nm through 550 nm. 
In order to ensure adequate visibility through the protective eyewear, 
the luminous transmittance shall not be less than 1.0 percent. Spectral 
transmittance and luminous transmittance must be measured in accordance 
with clause 32.102 of IEC 60335-2-27, Ed. 5.0, which is incorporated by 
reference.
    (5) Compatibility of lamps. An ultraviolet lamp shall not be 
capable of insertion and operation in either the ``single-contact 
medium screw'' or the ``double-contact medium screw'' lampholders 
described in C81.10-1976, which is incorporated by reference.
    (d) Label requirements. In addition to the labeling requirements in 
part 801 of this chapter and the certification and identification 
requirements of Sec. Sec.  1010.2 and 1010.3 of this chapter, each 
sunlamp product and ultraviolet lamp is subject to the labeling 
requirements prescribed in this paragraph and paragraph (e) of this 
section.
    (1) Labels for sunlamp products. Each sunlamp product shall have 
labels which contain:
    (i) A warning statement with the following language and format:
    [GRAPHIC] [TIFF OMITTED] TP22DE15.003
    
    (ii) Exposure position(s) that may be expressed either in terms of 
a distance specified both in meters and in feet (or in inches) or 
through the use of markings or other means to indicate clearly the 
recommended exposure position.
    (iii) Directions for achieving the recommended exposure position(s) 
and a warning that the use of other positions may result in 
overexposure.
    (iv) The manufacturer's recommended exposure schedule, including 
maximum exposure times per session, and overall maximum exposure time, 
in minutes, and spacing of sequential exposures. This schedule, with 
the following exceptions, must be developed in accordance with Annex DD 
of IEC 60335-2-27, Ed. 5.0, which is incorporated by reference.:
    (A) The maximum single dose (which corresponds to the maximum timer 
interval at 1040.20(c)(2)(ii)) is 500 J/m\2\ (not 600 J/m\2\ as stated 
in Annex DD).
    (B) Information regarding the maximum number of exposures per year 
must be based on a maximum yearly dose of 15 kJ/m\2\, weighted 
according to the erythema action spectrum shown in figure 103 of IEC 
60335-2-27, Ed. 5.0.

[[Page 79521]]

    (C) The exposure schedule must also include the following warning: 
``Skin Type I individuals (always burns, never tans) should never use 
sunlamp products.'' The exposure schedule must also include the 
statement: ``Maximum sessions per week = 2.''
    (D) Example schedule. For a sunlamp product whose maximum exposure 
time (Te) = 20 minutes, the following table provides an example of what 
the exposure schedule might look like where a single tanning course 
covers a 4-week period:

------------------------------------------------------------------------
 
------------------------------------------------------------------------
               Manufacturer-Recommended Exposure Schedule
------------------------------------------------------------------------
            Maximum exposure time must not exceed 20 minutes
------------------------------------------------------------------------
                                Session #
------------------------------------------------------------------------
1                2        3        4        5        6        7        8
------------------------------------------------------------------------
                      Minutes (maximum) per session
------------------------------------------------------------------------
4                6        8       10       13       16       20       20
------------------------------------------------------------------------
                Minimum time between exposures = 48 hours
   Maximum sessions per week = 2 Maximum tanning courses per year = 6
------------------------------------------------------------------------
   Skin Type I individuals (always burns, never tans) should never use
                            sunlamp products
------------------------------------------------------------------------

    (v) A statement indicating the time it may take before the expected 
results appear.
    (vi) The designation of the ultraviolet lamp equivalency code range 
to be used in the sunlamp product as defined in Clause 22.111 and Annex 
CC of IEC 60335-2-27, Ed. 5.0, which is incorporated by reference.
    (2) Labels for ultraviolet lamps. Each ultraviolet lamp shall have 
a label which contains:
    (i) The warning: ``Sunlamp--DANGER--Ultraviolet radiation. Follow 
instructions.''
    (ii) The UV lamp equivalency code as defined in Annex CC of IEC 
60335-2-27, Ed. 5.0, which is incorporated by reference. The 
availability of this incorporation by reference is given in paragraph 
(i) of this section. In determining the ``UV code'' component of the UV 
lamp equivalency code, output must be measured in accordance with IEC 
61228, Ed. 2.0 (iii) The model identification, if applicable.
    (iv) The words ``Use ONLY in fixture equipped with a timer.''
    (3) Label specifications. (i) The labels prescribed in paragraph 
(d)(1) of this section for sunlamp products shall be permanently 
affixed or inscribed on the product when fully assembled for use so as 
to be legible and readily accessible to view by the person who will be 
exposed immediately before the use of the product. The labels shall be 
of sufficient durability to remain legible throughout the expected 
lifetime of the product. To be legible and readily accessible to view, 
the sunlamp product warning statement required by paragraph (d)(1)(i) 
of this section shall comply with the following:
    (A) It shall appear on a prominent part or panel displayed under 
normal conditions of use so that it is readily accessible to view 
whether the tanning bed canopy (or tanning booth door) is open or 
closed when the person who will be exposed approaches the equipment;
    (B) It shall be physically separate and visually distinct from the 
other required label information;
    (C) It shall meet the following font size and font color 
requirements: The lettering in the word ``DANGER'' shall be at least 10 
millimeters (height), at least double the height of the other words in 
the warning statement, in all capital letters, and in red or another 
font color that is legible and distinct from the other words in the 
warning statement. The lettering in the other words in the warning 
statement shall be at least 5 millimeters (height) and in lower case or 
title case.
    (ii) The information prescribed in paragraph (d)(2) of this section 
for ultraviolet lamps shall be permanently affixed or inscribed on the 
lamp itself so as to be legible and readily accessible to view, as well 
as on the packaging of the lamp.
    (iii) If the size, configuration, design, or function of the 
sunlamp product or ultraviolet lamp would preclude compliance with the 
requirements for any required label or would render the required 
wording of such label inappropriate or ineffective, the Director, 
Office of In Vitro Diagnostics and Radiological Health, Center for 
Devices and Radiological Health, on the Director's own initiative or 
upon written application by the manufacturer, may approve alternate 
means of providing such information or alternate wording for such 
label, as appropriate.
    (iv) In lieu of permanently affixing or inscribing tags or labels 
on the ultraviolet lamp as required by Sec. Sec.  1010.2(b) and 
1010.3(a) of this chapter, the manufacturer of the ultraviolet lamp may 
permanently affix or inscribe such required tags or labels on the lamp 
packaging uniquely associated with the lamp, if the name of the 
manufacturer and month and year of manufacture are permanently affixed 
or inscribed on the exterior surface of the ultraviolet lamp so as to 
be legible and readily accessible to view.
    (v) A label may contain statements or illustrations in addition to 
those required by this paragraph if the additional statements are not 
false or misleading in any particular, e.g., if they do not diminish 
the impact of the required statements, and are not prohibited by this 
chapter.
    (e) Informational requirements--User information. Each manufacturer 
of a sunlamp product or ultraviolet lamp shall provide or cause to be 
provided to purchasers and, upon request, to others at a cost not to 
exceed the cost of publication and distribution, adequate instructions 
for use to minimize the potential for injury to the user, including the 
following information:
    (1) Sunlamp Products. The users' instructions for a sunlamp product 
shall contain:
    (i) A reproduction of all the label information required by 
paragraph (d)(1) of this section prominently displayed at the beginning 
of the instructions.
    (ii) A statement of the maximum number of people who may be exposed 
to the sunlamp product at the same time and a warning that only that 
number of protective eyewear has been provided.
    (iii) Instructions for the proper operation of the sunlamp product 
including the function, use, and setting

[[Page 79522]]

of the timer and other controls, and the use of protective eyewear.
    (iv) Instructions for obtaining repairs and recommended replacement 
components and accessories which are compatible with the sunlamp 
product, including compatible protective eyewear, ultraviolet lamps, 
timers, reflectors, and filters, which will, when installed and used as 
instructed, result in continued compliance with the standard.
    (v) Manufacturers of sunlamp products shall provide as an integral 
part of any user instruction or operation manual that is regularly 
supplied with the product, or, if not so supplied, shall cause to be 
provided with each sunlamp product: Adequate instructions for assembly, 
operation, and maintenance, including clear warnings concerning 
precautions to avoid possible exposure to ultraviolet radiation during 
assembly, testing, and maintenance, and a schedule of maintenance 
necessary to keep the sunlamp product in compliance with this section.
    (2) Ultraviolet lamps. The users' instructions for an ultraviolet 
lamp not accompanying a sunlamp product shall contain:
    (i) A reproduction of the label information required in paragraph 
(d)(2) of this section, prominently displayed at the beginning of the 
instructions.
    (ii) A warning that the instructions accompanying the sunlamp 
product must always be followed to avoid or to minimize potential 
injury.
    (3) Promotional materials. Manufacturers of sunlamp products shall 
provide or cause to be provided in all catalogs, specification sheets, 
and descriptive brochures intended for consumers in which sunlamp 
products are offered for sale, and on all consumer-directed Web pages 
on which sunlamp products are offered for sale, a legible reproduction 
(color optional) of the warning statement required by paragraph 
(d)(1)(i) of this section.
    (f) Test for determination of compliance. Tests on which 
certification under Sec.  1010.2 of this chapter is based shall account 
for all errors and statistical uncertainties in the process and, 
wherever applicable, for changes in radiation emission or degradation 
in radiation safety with age of the sunlamp product. Measurements for 
certification purposes shall be made under those operational 
conditions, lamp voltage, current, and position as recommended by the 
manufacturer. For these measurements, the measuring instrument shall be 
positioned at the recommended exposure position and so oriented as to 
result in the maximum detection of the radiation by the instrument. The 
performance requirements for the measuring instrument specified in IEC 
60335-2-27, Ed. 5.0 Clause 32.101, which is incorporated by reference, 
shall apply.
    (g) Modification of certified sunlamp products. The modification of 
a sunlamp product, previously certified under Sec.  1010.2 of this 
chapter, constitutes manufacturing under the Federal Food, Drug, and 
Cosmetic Act if the modification affects any aspect of the product's 
performance or intended function(s) for which this section has an 
applicable requirement. The person who performs such modification shall 
recertify and re-identify the sunlamp product in accordance with the 
provisions of Sec. Sec.  1010.2 and 1010.3 of this chapter.
    (h) Medical device classification regulation. Sunlamp products and 
ultraviolet lamps intended for use in sunlamp products are subject to 
special controls and restrictions on sale, distribution, and use as set 
forth in Sec.  878.4635 of this chapter.
    (i) Incorporation by reference. The standards required in this 
section are incorporated by reference into this section with the 
approval of the Director of the Federal Register under 5 U.S.C. 552(a) 
and 1 CFR part 51. All approved material is available for inspection at 
the Food and Drug Administration, Division of Dockets Management, 5630 
Fishers Lane, Rm. 1061, Rockville, MD 20852, and is available from the 
following sources. It is also available for inspection at the National 
Archives and Records Administration (NARA). For information on the 
availability of this material at NARA, call 202-741-6030, or go to 
http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.
    (1) American National Standards Institute (ANSI), 1889 L St. NW., 
11th Floor, Washington, DC 20036, [email protected], www.ansi.org, 
202-293-8020.
    (i) ANSI C81.10-1976, ``Specifications for Electric Lamp Bases and 
Holders--Screw-Shell Types,'' dated September 1976.
    (ii) [Reserved]
    (2) International Electrotechnical Commission (IEC), EC Central 
Office, 3 rue de Varembe, CH-1211 Geneva 20, Switzerland, www.iec.ch, 
call 41-22-919-02-11.
    (i) IEC 60335-2-27, Ed. 5.0: 2009-12, ``Household and Similar 
Electrical Appliances--Safety--Part 2-27: Particular Requirements for 
Appliances for Skin Exposure to Ultraviolet and Infrared Radiation,'' 
dated December 2009.
    (ii) IEC 61228, Ed. 2.0, ``Fluorescent Ultraviolet Lamps Used for 
Tanning--Measurement and Specification Method,'' dated January 2008.

    Dated: December 16, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-32023 Filed 12-18-15; 8:45 am]
 BILLING CODE 4164-01-P