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www.theita.com[Congressional Bills 111th Congress]
[From the U.S. Government Printing Office]
[H.R. 4520 Introduced in House (IH)]
111th CONGRESS
2d Session
H. R. 4520
To help prevent the occurrence of cancer resulting from the use of
ultraviolet tanning lamps by imposing more stringent controls on the
use of such devices, and for other purposes.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
January 26, 2010
Mrs. Maloney (for herself, Mr. Dent, Mr. Grijalva, and Mr. Brady of
Pennsylvania) introduced the following bill; which was referred to the
Committee on Energy and Commerce
_______________________________________________________________________
A BILL
To help prevent the occurrence of cancer resulting from the use of
ultraviolet tanning lamps by imposing more stringent controls on the
use of such devices, and for other purposes.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Tanning Bed Cancer Control Act of
2010''.
SEC. 2. FINDINGS.
Congress finds as follows:
(1) One million Americans--70 percent of whom are girls and
women--visit a tanning salon each day.
(2) In July 2009, the World Health Organization
International Agency for Research on Cancer Monograph Working
Group raised the classification of the use of UV-emitting
tanning devices to Group 1, ``carcinogenic to humans.''
(3) The new carcinogen classification places tanning beds
alongside tobacco smoke, asbestos, and uranium as known cancer-
causing agents.
(4) The World Health Organization reports that the risk of
cutaneous melanoma is increased by 75 percent when use of
tanning devices starts before 30 years of age.
(5) According to the American Academy of Dermatology, there
were over 120,000 new melanomas diagnosed in the United States
during 2009 and approximately 8,650 people were estimated to
die from melanoma during 2009.
(6) In a December 2008 Report to Congress, FDA determined,
through its own analysis, that the current warning labels for
indoor tanning devices do not effectively communicate the risks
associated with indoor tanning and is therefore reviewing
modifications to the labeling requirements in an effort to
better inform consumers about the risks associated with sunlamp
products.
(7) According to section 514 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360d), the Secretary of Health and
Human Services determines performance standards are established
by providing that a drug or device allows for the reasonable
assurance of safe and effective performance.
(
If tanning devices do not provide reasonable assurances
of safe and effective performance, the Secretary shall seek to
reclassify these devices as is most appropriate based on the
scientific evidence and to put in place safeguards for consumer
access to these devices.
SEC. 3. RECLASSIFICATION.
(a) Study.--Not later than 1 year after the date of enactment of
this Act, the Commissioner of Food and Drugs (hereinafter in this Act
referred to as the ``Commissioner'') shall complete a study to examine
the classification of ultraviolet tanning lamps as class I devices.
(b) Reclassification.--Not later than 1 year after the completion
of the study under subsection (a), the Commissioner shall, based on the
results of such study--
(1) issue a rule providing for the reclassification under
section 513(e) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 260c(e)) of an ultraviolet tanning lamp as a class II or
class III device; or
(2) submit to the Congress a report that provides a
justification for not issuing such a rule.
SEC. 4. PERFORMANCE STANDARDS.
(a) Study.--Not later than 1 year after the date of enactment of
this Act, the Commissioner shall complete a study on performance
standards established under section 514 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360d) for ultraviolet tanning lamps to examine
the adequacy of such performance standards.
(b) Revision of Performance Standards.--Except as provided in
subsection (c), the Commissioner, based on the results of the study
under subsection (a), shall, not later than 1 year after the completion
of such study--
(1) issue a rule providing for more stringent performance
standards for ultraviolet tanning lamps, including with respect
to the strength of ultraviolet rays emitted by such devices and
the amount of time a user should remain exposed to such
devices; or
(2) submit to the Congress a report that provides a
justification for not issuing such a rule.
(c) Labeling Requirements.--The Commissioner shall carry out the
recommendations made in the report submitted under section 230 of the
Food and Drug Administration Amendments Act of 2007 (Public Law 110-85)
regarding the labeling of ultraviolet tanning lamps.
SEC. 5. NO LIMITATION ON RECALL AUTHORITY.
Nothing in this Act shall be construed to limit the authority of
the Commissioner under section 518(e) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360h(e)) with regard to an ultraviolet tanning
lamp.
SEC. 6. DEFINITIONS.
In this Act:
(1) The term ``ultraviolet tanning lamp''--
(A) refers to an ultraviolet ray-emitting device
for purposes of tanning, including indoor tanning
devices and sunlamps for tanning; and
(B) notwithstanding subparagraph (A), does not
include an ultraviolet ray-emitting device for purposes
of use as part of a treatment regimen prescribed by a
licensed health care professional.
(2) The terms ``class I'', ``class II'', and ``class III''
have the meanings given such terms in section 513(h) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360c(h)).
(3) The terms ``device'', ``interstate commerce'',
``label'', and ``labeling'' have the meanings given such terms
under section 201 of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 321).
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