[Congressional Bills 111th Congress]
[From the U.S. Government Publishing 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.
            (8) 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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