[Congressional Bills 109th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4011 Introduced in House (IH)]







109th CONGRESS
  1st Session
                                H. R. 4011

  To prohibit after 2008 the introduction into interstate commerce of 
 mercury intended for use in a dental filling, and for other purposes.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                            October 6, 2005

   Ms. Watson (for herself, Mr. Michaud, and Mr. Burton of Indiana) 
 introduced the following bill; which was referred to the Committee on 
                          Energy and Commerce

_______________________________________________________________________

                                 A BILL


 
  To prohibit after 2008 the introduction into interstate commerce of 
 mercury intended for use in a dental filling, 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 ``Mercury in Dental Fillings 
Disclosure and Prohibition Act''.

SEC. 2. FINDINGS.

    (a) General Findings.--The Congress finds as follows:
            (1) Elemental mercury and mercury compounds are known to be 
        toxic and hazardous to human health and to the environment.
            (2) Mercury is number three on the 2003 CERCLA Priority 
        List of Hazardous Substances, behind arsenic and lead.
            (3) A dental amalgam, commonly referred to as a ``silver 
        filling'', consists of 42 to 58 percent mercury.
            (4) Consumers may be deceived by the use of the term 
        ``silver'' to describe a dental amalgam, which contains 
        substantially more mercury than silver.
            (5) The American Dental Association estimates that the 
        dental industry places approximately 70,000,000 dental amalgams 
        annually and each dental amalgam may contain \1/2\ to \3/4\ of 
        a gram of mercury, depending on the size of the filling.
            (6) The mercury contained in dental amalgam is continually 
        emitted in the form of mercury vapor, and the total amount of 
        mercury released depends upon the total number of fillings; 
        their age, composition, and surface area; the intraoral 
        presence of other metals; dietary and lifestyle habits; and 
        other chemical and metabolic conditions affecting the mouth.
            (7) When mercury vapors are inhaled, most of the mercury 
        (about 80 percent) enters the bloodstream directly through the 
        lungs and then rapidly deposits preferentially in the brain and 
        kidneys as well as other parts of the body.
            (8) Mercury toxicity is a retention toxicity (total body 
        burden) that builds up over years of exposure, and is therefore 
        dependent on all sources of mercury to which an individual may 
        be exposed.
            (9) Recently funded research by the National Institutes of 
        Health has concluded that when inorganic mercury is located in 
        brain tissue, researchers are unable to demonstrate an 
        appreciable half-life, or decrease, of mercury over time (more 
        than 120 days). The implications of this conclusion are that 
        dental amalgam exposure will permanently increase mercury body 
        burden.
            (10) According to the World Health Organization, the 
        estimated average daily intake and retention of mercury from 
        dental amalgam ranges from 3 to 27 micrograms per day, and is 
        greater than all other sources combined.
            (11) The California Dental Association, by court order, 
        requires postings of warnings about mercury fillings in 
        California Dental Offices as of March 9, 2003. The warnings 
        read ``NOTICE TO PATIENTS: PROPOSITION 65 WARNING: Dental 
        Amalgam, used in many dental fillings, causes exposure to 
        mercury, a chemical known to the state of California to cause 
        birth defects or other reproductive harm''.
            (12) United States consumers and parents have a right to 
        know, in advance, the risks of placing a product containing a 
        substantial amount of mercury in their mouths or the mouths of 
        their children.
            (13) The Food and Drug Administration added Health Canada 
        warnings regarding mercury in dental amalgam to a consumer 
        update issued on December 31, 2002.
            (14) According to certain scientific studies, Health 
        Canada, and the Agency for Toxic Substances and Disease 
        Registry, children and pregnant women are at particular risk 
        for exposure to mercury contained in dental amalgam.
            (15) According to the Agency for Toxic Substances and 
        Disease Registry, the mercury from amalgam passes through the 
        placenta of pregnant women and through the breast milk of 
        lactating women, increasing health risks to both unborn 
        children and newborn babies.
            (16) The National Academy of Sciences estimated that ``over 
        600,000 children are born each year at risk for adverse 
        neurodevelopmental effects due to in utero exposure to methyl 
        mercury''. This report urged the need to understand the 
        relative amount of mercury attributable to dental amalgam and 
        to thimerosal in vaccines.
            (17) Studies show that a variety of commonly found human 
        intestinal and oral bacteria can methylate mercury. In this 
        way, the mercury vapor from fillings biotransforms into the 
        highly neurotoxic and teratogenic methylmercury.
            (18) The use of mercury in any product being put into the 
        body is opposed by many health groups, such as the American 
        Public Health Association, the California Medical Association, 
        and Health Care Without Harm.
            (19) Highly effective and durable alternatives to mercury-
        based dental fillings exist, but many publicly and privately 
        financed health plans do not allow consumers to choose 
        alternatives to dental amalgam.
    (b) Environmental Findings.--In addition to the findings of 
subsection (a), the Congress finds as follows:
            (1) Mercury wastewater released from dental clinics has 
        been shown to fail the Environmental Protection Agency's 
        toxicity characteristic leaching procedure and, therefore, is 
        regulated as hazardous waste.
            (2) Research from the Naval Dental Research Institute 
        indicates that, when discharged to the environment, conditions 
        may be right for waste dental mercury to methylate, become 
        bioavailable, and subsequently biomagnify in fish as methyl 
        mercury, the most toxic form of mercury.
            (3) Forty-eight States, the District of Columbia, and the 
        United States Territory of American Samoa have issued 2,362 
        fish consumption advisories to their residents due to mercury 
        contamination as of 2003.
            (4) The Food and Drug Administration has issued fish 
        consumption advisories due to levels of mercury in 
        commercially-caught fish and, in January 2001, warned pregnant 
        woman and young children not to eat certain marine fish.
            (5) According to the Environmental Protection Agency, 
        United States dentists use approximately 34 tons of mercury per 
        year.
            (6) A report issued on June 5, 2002, by the Mercury Policy 
        Project, the Sierra Club, Health Care Without Harm, Clean Water 
        Action, and the Toxics Action Center stated that, because of 
        mercury fillings, dental offices are now the leading source of 
        mercury in the Nation's wastewater.
            (7) Mercury from dental amalgam can enter the environment 
        during any point of the product's life-cycle. This includes 
        placement or removal of fillings; through bodily excretions; 
        when sewage sludge is incinerated, spread on crops, or dumped 
        in land fills; when vapor is released or land filled; when 
        vapor is released directly from the filling (which increases 
        with brushing, chewing, and consuming hot foods or salt); and 
        during cremation. Currently there are no requirements for 
        mercury capture before or during cremation.
            (8) In 2000, the Association of Metropolitan Sewerage 
        Agencies reported human wastes from individuals with dental 
        amalgam fillings to be the most significant source of domestic 
        mercury entering publicly owned treatment works, greater than 
        80 percent of the total contributing factors.
            (9) According to the Association of Metropolitan Sewerage 
        Agencies, removal of mercury from publicly owned treatment 
        works has been shown to cost $10,000,000 to $100,000,000 for 
        every pound removed.
            (10) Mercury use by the dental industry increased from 2 
        percent in 1980 to 22 percent of the total use of mercury in 
        the United States in 2001, because of drastic declines in 
        mercury use by other industries over that period.
            (11) Amalgam restorations were estimated to be 55 percent 
        of the total mercury product reservoir in 2004 by the 
        Environmental Protection Agency, and will therefore be a source 
        of environmental contamination into the future.
            (12) According to a joint study by the Environmental 
        Protection Agency and the Cremation Association of North 
        America, approximately 238 pounds of mercury, mostly from 
        dental amalgam fillings, were released from crematoria 
        nationally in 1999.
            (13) Cremation is chosen in approximately 30 percent of all 
        deaths, and this percentage is expected to increase every year.
            (14) According to industrial hygiene surveys, 6 to 16 
        percent of dental offices exceed the exposure levels for air 
        mercury permitted by Occupational Safety and Health 
        Administration standards.

SEC. 3. PROHIBITION ON INTRODUCTION OF DENTAL AMALGAM INTO INTERSTATE 
              COMMERCE.

    (a) Prohibition.--Section 501 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 351) is amended by adding at the end the 
following:
    ``(j) Effective January 1, 2009, if it contains mercury intended 
for use in a dental filling.''.
    (b) Transitional Provision.--For purposes of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 301 et seq.), effective December 31, 
2006, and subject to the amendment made by subsection (a), a device 
that contains mercury intended for use in a dental filling shall be 
considered to be misbranded, unless it bears a label that provides as 
follows: ``Dental amalgam contains approximately 50 percent mercury, a 
highly toxic element. Such product should not be administered to 
children less than 18 years of age, pregnant women, or lactating women. 
Such product should not be administered to any consumer without a 
warning that the product contains mercury, which is a highly toxic 
element, and therefore poses health risks.''.
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