Mercury in Dental Fillings Disclosure and Prohibition Act - Amends the Federal Food, Drug, and Cosmetic Act to deem adulterated (hence prohibited), effective January 1, 2009, any amalgam containing mercury intended for use in a dental filling.
Provides for a transition period, during which such a device may be manufactured and sold if it bears a specified warning label, until this Act becomes effective.
[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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Introduced in House
Introduced in House
Referred to the House Committee on Energy and Commerce.
Referred to the Subcommittee on Health.
Sponsor introductory remarks on measure. (CR H9282)
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