[Federal Register Volume 80, Number 245 (Tuesday, December 22, 2015)]
[Proposed Rules]
[Pages 79505-79522]
[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
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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:<PHONE_NUMBER>, or email to
<EMAIL_ADDRESS>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,<PHONE_NUMBER>.

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

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

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

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:

    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

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

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,

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

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

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

                                                     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,

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<PHONE_NUMBER>,
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-

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

    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   ..............

    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

(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.

    (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

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<PHONE_NUMBER>, 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_ADDRESS>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