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This section of the FEDERAL REGISTER
contains notices to the public of the proposed
issuance of rules and regulations. The
purpose of these notices is to give interested
persons an opportunity to participate in the
rule making prior to the adoption of the final
rules.

Proposed Rules Federal Register
7620
Vol. 67, No. 34
Wednesday, February 20, 2002

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
21 CFR Part 872
[Docket No. 01N–0067]
Dental Devices: Classification of
Encapsulated Amalgam Alloy and
Dental Mercury and Reclassification of
Dental Mercury; Issuance of Special
Controls for Amalgam Alloy
AGENCY: Food and Drug Administration,
HHS.

ACTION: Proposed rule.

SUMMARY: The Food and Drug Administration (FDA) is proposing three
actions that will provide consistent regulation of dental mercury and
dental amalgam products.

FDA is proposing to issue a separate classification regulation
for encapsulated amalgam alloy and
dental mercury, a preamendments
device, intended to be mixed in a singleuse
capsule to form filling material for
the treatment of dental caries as class II
(special controls); to amend the
classification for amalgam alloy, a class
II preamendments device, by adding
special controls; and to reclassify from
class I (general controls) to class II the
preamendments device dental mercury
intended for use as a component of
amalgam alloy in the restoration of a
dental cavity or broken tooth. These
actions are being taken because the
agency believes that there is sufficient
information to establish special controls
that will provide reasonable assurance
of the safety and effectiveness of these
devices. Elsewhere in this issue of the
Federal Register, FDA is announcing
the availability for comment of a draft
guidance document that is proposed as
a special control.
DATES: Submit written or electronic
comments by May 21, 2002. See section
XI of this document for the proposed
effective date of a final rule based on
this document.


ADDRESSES: Submit written comments
to the Dockets Management Branch
(HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20057. Submit

electronic comments to

http://www.fda.gov/dockets/ecomments .


FOR FURTHER INFORMATION CONTACT:

Susan Runner, Center for Devices and Radiological Health (HFZ–410),
Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850,
301–827–5283.

SUPPLEMENTARY INFORMATION:
I. Highlights of the Proposed Regulation

In light of the information described below, FDA has reconsidered its
regulatory approach to dental amalgam products. FDA is proposing to
regulate amalgam products in a uniform manner, and apply class II
special controls to these products to provide a reasonable
assurance of safety and effectiveness.

Specifically, FDA is proposing to:

1. Issue a separate classification regulation for encapsulated amalgam
alloy and dental mercury.
This product would be class II with special controls
consisting of conformance to voluntary
industry standard specifications in the
following:
(1) International Standards Organization ``(ISO) 1559:1995 Dental
Materials–Alloys for Dental Amalgam,''

and (2) American National Standards Institute/American Dental
Association (ANSI/ADA) ``Specification No. 6–1987
for Dental Mercury'' and FDA's
guidance document entitled ``Special
Control Guidance Document on
Encapsulated Amalgam, Amalgam
Alloy, and Dental Mercury Labeling.''
2. Reclassify dental mercury from
class I to class II with special controls
consisting of conformance to voluntary
industry standard specifications in
ANSI/ADA's ``Specification No. 6–1987
for Dental Mercury'' and FDA's
guidance document entitled ``Special
Control Guidance Document on
Encapsulated Amalgam, Amalgam
Alloy, and Dental Mercury Labeling.''
3. Amend the class II classification
regulation of amalgam alloy to provide
for special controls consisting of
conformance to voluntary industry
standard specifications in ``ISO
1559:1995 Dental Materials—Alloys for
Dental Amalgam'' and FDA's guidance
document entitled ``Special Control
Guidance Document on Encapsulated
Amalgam, Amalgam Alloy, and Dental
Mercury Labeling.''
II. Background (Regulatory Authorities)
The Federal Food, Drug, and Cosmetic
Act (the act) (21 U.S.C. 301 et seq.), as
amended by the Medical Device
Amendments of 1976 (the 1976
amendments) (Public Law 94–295), the
Safe Medical Devices Act of 1990 (the
SMDA) (Public Law 101–629), and the
Food and Drug Administration
Modernization Act of 1997 (Public Law
105–115) established a comprehensive
system for the regulation of medical
devices intended for human use.
Section 513 of the act (21 U.S.C. 360c)
established three categories (classes) of
devices, depending on the regulatory
controls needed to provide reasonable
assurance of their safety and
effectiveness. The three categories of
devices are class I (general controls),
class II (special controls), and class III
(premarket approval).
Under the 1976 amendments, class II
devices were defined as those devices
for which there is insufficient
information to show that general
controls themselves will assure safety
and effectiveness, but there is sufficient
information to establish performance
standards to provide such assurance.
The SMDA broadened the definition of
class II devices to mean those devices
for which there is insufficient
information to show that general
controls themselves will assure safety
and effectiveness, but there is sufficient
information to establish special controls
to provide such assurance. Special
controls may include performance
standards; postmarket surveillance;
patient registries; and the development,
and dissemination of guidelines,
recommendations, and any other
appropriate actions the agency deems
necessary (section 513(a)(1)(B) of the
act).
Under section 513 of the act, devices
that were in commercial distribution
before May 28, 1976 (the date of
enactment of the amendments),
generally referred to as preamendments
devices, are classified after FDA has: (1)
Received a recommendation from a
device classification panel (an FDA
advisory committee); (2) published the
panel's recommendation for comment,
along with a proposed regulation
classifying the device; and (3) published
a final regulation classifying the device.
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FDA has classified most
preamendments devices under these
procedures.
Devices that were not in commercial
distribution prior to May 28, 1976,
generally referred to as postamendments
devices, are classified automatically by
statute (section 513(f) of the act) into
class III without any FDA rulemaking
process. Those devices remain in class
III and require premarket approval,
unless and until FDA issues an order
finding the device to be substantially
equivalent, under section 513(i) of the
act, to a predicate device that does not
require premarket approval. The agency
determines whether new devices are
substantially equivalent to previously
marketed devices by means of
premarket notification procedures in
section 510(k) of the act (21 U.S.C.
360(k)) and part 807 of the regulations
(21 CFR part 807).
A preamendments device that has
been classified into class III may be
marketed, by means of premarket
notification procedures, without
submission of a premarket approval
application (PMA) until FDA issues a
final regulation under section 515(b) of
the act (21 U.S.C. 360e(b)) requiring
premarket approval.
Reclassification of classified
preamendments devices is governed by
section 513(e) of the act. This section
provides that FDA may, by rulemaking,
reclassify a device (in a proceeding that
parallels the initial classification
proceeding) based upon ``new
information.'' The reclassification can
be initiated by FDA or by the petition
of an interested person. The term ``new
information,'' as used in section 513(e)
of the act, includes information
developed as a result of a reevaluation
of the data before the agency when the
device was originally classified, as well
as information not presented, not
available, or not developed at that time.
(See, e.g., Holland Rantos v. United
States Department of Health, Education,
and Welfare, 587 F.2d 1173, 1174 n.1
(D.C. Cir. 1978); Upjohn v. Finch, 422
F.2d 944 (6th Cir. 1970); Bell v. Goddard
366 F.2d 177 (7th Cir. 1966).
Reevaluation of the data previously
before the agency is an appropriate basis
for subsequent regulatory action where
the reevaluation is made in light of
changes in ``medical science.'' (See
Upjohn v. Finch, supra, 422 F.2d at
951.) However, regardless of whether
data before the agency are past or new
data, the ``new information'' on which
any reclassification is based is required
to consist of ``valid scientific evidence,''
as defined in section 513(a)(3) of the act
and § 860.7(c)(2) (21 CFR 860.7(c)(2)).
FDA relies upon ``valid scientific
evidence'' in the classification process
to determine the level of regulation for
devices. For the purpose of
reclassification, the valid scientific
evidence upon which the agency relies
must be publicly available. Publicly
available information excludes trade
secret and/or confidential commercial
information, e.g., the contents of a
pending PMA. (See section 520(c) of the
act (21 U.S.C.360j(c)).
III. Regulatory History of the Devices
Dental amalgam is a dental restorative
material that is used as filling material
in the treatment of dental caries. Dental
amalgam is a mixture of approximately
equal parts of elemental mercury (43 to
54 percent) and an amalgam alloy
containing other metals, predominately
silver, but also tin and copper, with
smaller amounts of zinc, palladium, or
indium sometimes present. The mercury
and amalgam alloy components are
mixed in the dentist's office to form
dental amalgam. FDA has regulated
dental mercury and amalgam alloy
separately, with dental mercury
§ 872.3700 (21 CFR 872.3700) being
regulated as a class I device and
amalgam alloy § 872.3050 (21 CFR
872.3050) as a class II device.
In the Federal Register of December
30, 1980 (45 FR 85962), FDA published
a proposed rule to classify dental
mercury (§ 872.3700) into class II, based
on the recommendation of the panel.
Subsequently, in the Federal Register of
August 12, 1987 (52 FR 30082 at 30089),
FDA issued a final rule classifying
dental mercury into class I instead of
into class II, as proposed. FDA stated
that it believed that, at that time, there
was no valid scientific evidence of
systematic poisoning to patients from
amalgam containing mercury to justify
classifying the device into class II (see
52 FR 30082 at 30089).
Although the agency acknowledged
the risks presented by dental mercury
(i.e., mercury poisoning and adverse
tissue reaction), the agency believed that
general controls, including labeling for
the device bearing adequate directions
for use and warnings under section 502
of the act (21 U.S.C. 352), would warn
dentists about the rare risks of allergic
reactions among patients and the risk of
toxicity to dental health professionals.
The agency concluded that the
establishment of performance standards
for these devices would not reduce
these risks. Accordingly, FDA found
that general controls alone were
sufficient to provide reasonable
assurance of the safety and effectiveness
of the device. In the same issue of the
Federal Register, FDA classified
amalgam alloy into class II because of
the potential risks to safety and
effectiveness that could result from
variations in chemical formulation
related to percent composition and
types of materials.
In the Federal Register of August 12,
1987 (52 FR 30082) and November 20,
1990 (55 FR 48436), FDA classified a
total of 124 preamendments generic
types of dental devices, including dental
mercury (§ 872.3700) and amalgam alloy
(§ 872.3050). Due to an inadvertent
error, the preamendments device
encapsulated amalgam alloy and dental
mercury, was not separately classified.
Encapsulated amalgam alloy and dental
mercury is a device that consists of
measured proportions of amalgam alloy
and dental mercury, both separately
sealed, but within the same single-use
capsule, ready to be triturated to form
an amalgam alloy filling material for use
in the restoration of a dental cavity.
Encapsulated amalgam alloy and dental
mercury are now regulated as class II
devices under the amalgam alloy
classification (§ 872.3050).
IV. Scientific Review Related to Dental
Mercury and Amalgam
A. Comprehensive Assessment of Dental
Amalgam by the United States Public
Health Service
In 1991 to 1992, under the auspices of
the Committee to Coordinate
Environmental Health and Related
Programs (CCEHRP), the U.S. Public
Health Service (PHS), a component of
the Department of Health and Human
Services (HHS), performed a
comprehensive risk assessment of
dental amalgam.
The PHS performed this
comprehensive risk assessment because
of heightened public concern about the
safety of this product as a result of
anecdotal reports of mercury toxicity
from amalgam fillings and the
alleviation of chronic disease conditions
when the fillings were removed. These
reports and the public's reaction to them
prompted senior PHS officials to order
a fresh look at all relevant data to
determine if such safety concerns had
any basis in fact. In 1993, a CCEHRP
Subcommittee on Risk Management
issued a report on its findings (Ref. 1)
(hereinafter referred to as the PHS
report).
In preparing this assessment, the
CCEHRP relied upon a number of
scientific review groups that included
clinicians, scientists, and public health
experts from the PHS, the
Environmental Protection Agency, and
the health care and academic sectors
(Ref. 1). One group referred to as the Ad
Hoc Subcommittee on the Benefits of
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Dental Amalgam (hereinafter referred to
as the Benefits Assessment
Subcommittee), assessed the benefits of
dental amalgam. A separate group, the
Subcommittee on Risk Assessment
(hereinafter referred to as the Risk
Assessment Subcommittee), examined
the potential health risks associated
with dental amalgam restorations.
The Risk Assessment Subcommittee,
comprised of 34 senior level experts
from the fields of health promotion and
disease prevention, dentistry, dental
materials, toxicology, and biostatistics,
reviewed the existing body of scientific
literature (Ref. 1). It examined nearly
120 publications that reported the
results of studies on levels of exposure
to mercury and its salts. In conducting
its review, the Risk Assessment
Subcommittee paid close attention to
the amount of mercury absorbed by
study subjects and the consequences, if
any, of lifetime exposure among people
with dental amalgam restorations (Ref.
1).
The Risk Assessment Subcommittee
found that historic experience with
dental amalgams did not offer
persuasive evidence of adverse health
effects related to amalgam treatments
other than a few reported cases of
hypersensitivity (Ref. 1). In terms of
evidence concerning adverse effects of
low level, long-term mercury exposure,
the Risk Assessment Subcommittee
reviewed studies that reported
neurological and psychological changes
resulting from long-term, low-level
mercury exposure. The Risk Assessment
Subcommittee could not draw
unambiguous conclusions or develop a
risk assessment based on these
endpoints because these studies were
judged to have serious methodological
flaws (Ref. 1).
Given the shortcomings of the
occupational studies, the Risk
Assessment Subcommittee also decided
against using occupational exposure
data as the basis for establishing an
acceptable level of exposure to longterm,
low-level mercury vapor: in other
words, the Risk Assessment
Subcommittee recommended against a
``no observed adverse effect level'' (Ref.
1).
Based on its review, the Risk
Assessment Subcommittee arrived at
four general conclusions:
1. In low-level occupational exposure,
the subclinical effects detected have
occurred in groups with mean tissue
mercury levels that are only tenfold
higher than those of the general
population. However, the relationship
between the observed effects and the
tissue levels is unclear, as is the
relationship between subclinical effects
and a hazard to health.
2. Available data are not sufficient to
indicate that health hazards can be
identified in nonoccupationally exposed
persons. Because there are no
scientifically acceptable studies with
sensitive, standardized measurements
for physiological and behavioral
changes in nonoccupationally exposed
persons, it is not possible to determine
whether those changes observed in
persons with low-level occupational
exposure to mercury might also occur as
a result of exposure to mercury from
dental amalgams. Adverse health
consequences, however, cannot be
totally dismissed.
3. The margin of safety may be lower
in some individuals because of
previously developed sensitivity to
mercury or because body burdens of
mercury are already high as a result of
past exposure to other sources. It is
possible, therefore, that some persons
may respond adversely to the
incremental exposure derived from
dental amalgam restorations.
4. At the mercury doses produced by
amalgam fillings, the evidence is not
persuasive that the wide variety of
nonspecific symptoms attributable to
fillings and ``improvement'' after their
removal are ascribable to mercury from
the fillings. Conversely, the evidence is
not persuasive that the potential for
toxicity at the levels attributable to
dental amalgams should be totally
disregarded. The potential for effects at
levels of exposure produced by dental
amalgam restorations has not been fully
explored (Ref. 1).
In addition to examining the risks of
dental amalgam, a companion PHS
subcommittee reviewed the benefits of
this product (PHS report Ref. 1). It
concluded that dental amalgam, which
has been used successfully to treat
millions of individuals for over 100
years, is an effective restorative material
that offers many advantages over other
materials. These advantages include
wide potential applications, ease of
manipulation, reasonable clinical
serviceability, and relatively low cost.
These findings, which are discussed in
greater detail later in this document,
were subjected to external review and
found to be highly credible (Ref. 1).
On the basis of the assessment of
available science on the risks and
benefits of amalgam products, the PHS
report recommended that FDA, the
National Institute of Health, Centers for
Disease Control and Prevention, Office
of the Assistant Secretary for Health,
and the National Institute of Dental
Research implement a comprehensive
strategy to address concerns about
amalgam products. Specifically, the
PHS report recommended the
development of a research agenda, a
method to monitor research, and a
public and professional educational
campaign. The PHS report also
recommended that FDA carry out the
following regulatory initiatives: (1)
Combine elemental mercury and dental
alloy, which are presently regulated
separately, into a single product for
regulatory purposes; (2) require
manufacturers of all dental restorative
materials, including dental amalgam, to
label their products with the ingredients
to help dentists identify patients who
may exhibit allergic hypersensitivity to
these substances; and (3) encourage
dentists and patients to report to FDA
adverse effects from all restorative
materials. (Ref. 1).
The HHS Environmental Health
Policy Committee, the successor to the
CCEHRP, met in mid-1995 and
reaffirmed the findings and policy
approaches outlined in the 1993 PHS
report (Ref. 2).
B. Citizen Petitions
In 1993, several individuals filed
citizen petitions related to the
regulation of dental amalgam and dental
mercury (Ref. 3). These petitions
requested that FDA take numerous
actions with respect to dental amalgam
and mercury, including banning dental
mercury, reclassifying dental mercury
into class III, imposing restrictions on
amalgam, conducting environmental
assessments and issuing environmental
policy statements, issuing policy
statements addressing patients and
health care workers, and convening a
special panel to review the merits of
these requests.
The petitioners submitted numerous
scientific publications they believed
supported the conclusion that dental
mercury and amalgam were unsafe. FDA
convened a group of experts to assess
these additional studies. After reviewing
the additional studies cited in the
petitions, the group of experts did not
find that any of the studies supported
claims that individuals with dental
amalgam fillings will experience
adverse effects including neurologic,
renal, or developmental effects. Their
conclusions concerning the risks of
amalgam were consistent with the
conclusions in the 1993 and 1995 PHS
reports. (Ref. 4).
After review of the existing
information about the safety of dental
amalgam and mercury, including
additional information cited by
petitioners, FDA responded that it
intended to propose to place amalgam
products into class II, not class III. FDA
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further responded that it did not intend
to ban mercury or impose restrictions on
the use of amalgam products by certain
subpopulations (Ref. 5).
C. U.S. Government Research
The U.S. Government has funded
several studies related to dental
amalgam. Since 1982, a large-scale
epidemiological study, commonly
referred to as the ``Ranch Hand Study,''
has been continuing to assess the
possible links between exposure of the
U.S. military personnel to the herbicide
Agent Orange, used during the Vietnam
War, and reported health effects. The
extensive medical and oral health
database developed in support of this
study, drawn from approximately 1,200
study participants, made it possible for
persons with different research interests
to use selected data in the pursuit of
their own studies. Oral health
information, dental records from
military archives, and measures of
mercury levels in blood and urine
samples enabled the National Institute
of Dental and Craniofacial Research to
initiate a two-pronged study. One aspect
of the study entailed the establishment
of mercury levels from amalgam fillings
and the occurrence of various reported
health symptoms. The other aspect
involved a longitudinal cohort
assessment in which the number of
amalgam restorations were determined
retrospectively and comparisons made
of reported health effects between
groups with high and low exposure
levels and those with no exposure. To
date, no discernible causal or
correlational connection has been
observed between study subjects with
amalgam fillings and adverse health
effects. The period of observation is
continuing. The government has
sponsored several other continuing
studies that relate to amalgam fillings
with results anticipated in 2003.
D. International Reviews on Safety of
Amalgam Fillings
There have been a number of major
reviews by international authorities of
the nature and magnitude of health risks
associated with dental amalgam
restorations. The majority of these
assessments are based upon extensive
reviews of the available body of relevant
scientific literature and consensus
among leading researchers and
renowned experts from the fields of oral
health, toxicology, medicine, and other
related disciplines. The following
overview identifies these individual
reviews and provides the overall
conclusions of each.
In 1994, an expert group convened by
Sweden's National Board of Health and
Welfare took the position that:
``Scrutiny of the results of recent
research * * * has not shown that
mercury from amalgam has an adverse
effect on health, with the exception of
isolated cases of allergic reactions'' (Ref.
6).
At the request of senior U.S. health
officials, in 1994, a delegation of PHS
scientists and regulators organized a
nine-country information exchange
forum in Berlin, Germany for the
purpose of determining the scientific
bases for national policies governing the
use of dental amalgam. In 1998, a report
memorializing the conclusions of this
group was published. The report
concluded that: (1) No systemic dosedependent
toxic effects have been
shown to be related to amalgam; (2)
local reactions to dental amalgam
fillings do occur but are relatively rare;
(3) the benefits of restoring teeth with
dental amalgam outweigh significantly
the documented risks; and (4) there is
no indication that clinically satisfactory
dental amalgam fillings should be
removed (Ref. 7).
In 1995, Canadian health authorities
released a report on amalgam safety
(Ref. 8), which concluded:
Dental amalgam contributes detectable
amounts of mercury to the [human] body,
and is the largest source of mercury exposure
for average Canadians. However, this
exposure is not causing illness in the general
population. Current evidence does not
indicate that mercury contributes to
Alzheimer's disease, amyotrophic lateral
sclerosis, multiple sclerosis or Parkinson's
disease.
In 1996, the University of Otego's
Wellington School of Medicine in New
Zealand, which serves as the World
Health Organization (WHO)
Collaborating Centre in Oral Health,
enlisted four prominent researchers to
conduct a review of available scientific
reports on amalgam safety. In a draft
report, three of the researchers
concluded: ``* * * the assumption of a
cause-and-effect relationship between
amalgam and cases of ill health is
evidence of an overreaction and unwise,
considering the endemic prevalence of
amalgam in the population'' (Ref. 9).
In 1997, the Canadian province of
Quebec undertook its own evaluation of
the state of the science relating to
amalgam safety. Taking a somewhat
equivocal stance, Quebec authorities
stated:
The mainstream scientific view holds that
mercury exposure, even at very low levels
attributable to dental amalgam, might be
affecting people adversely, but the evidence
currently available is inadequate to
determine if this is the case. Existing
evidence is weak, but the information base is
inadequate to conclude that dental amalgam
has no effects that might be of concern (Ref.
10).
In early 1997, WHO convened a
``consultation meeting'' at its
headquarters in Geneva, Switzerland to
re-visit WHO's policy on dental
amalgam use with the current science.
In attendance were government officials,
scientists, and representatives from the
dental profession and dental trade
industry from 10 of the world's major
industrialized nations and 2 of WHO's
regional offices. At the end of this
meeting, the participants issued the
following consensus statement:
Dental amalgam restorations are
considered safe, but components of amalgam
and other dental restorative materials may, in
rare instances, cause local side effects or
allergic reactions. The small amount of
mercury released from amalgam restorations,
especially during placement and removal,
has not been shown to cause any other
adverse health effects. (Ref 11).
In 1997, the Oral Health section of
WHO's Division of Non-Communicable
Diseases issued a publication based
upon the working papers and
presentations by participants at the 1997
WHO conference noted above. The
publication included and gave WHO
sanction to the consensus statement
adopted by the participants at the 1997
WHO consultation meeting and
provided supporting technical and
scientific evidence on a wide range of
discrete issues relating to dental
amalgam (Ref. 11).
For example, in a section entitled
``Direct Restorative Dental Materials in
Oral Health Care Amalgam, Composites
and Glass Ionomers,'' the document
states:
Expert groups, convened by the Swedish
National Board of Health and Welfare and the
Swedish Medical Research Council (SOS,
1987) and the Department of Health and
Human Services, USA (1993), have studied
possible health effects of the use of mercurycontaining
amalgam. These study groups
concluded that while it is well documented
that individuals with amalgam fillings have
higher concentrations of mercury in all
tissues studied than those who have no
amalgam fillings, there is no direct evidence
of an adverse effect of mercury from amalgam
tooth fillings on general health (Ref. 11).
In the section titled ``Toxic and
Allergenic Risks Due to Dental
Biomaterials'', the document states:
Mercury from dental amalgam has been
accused of being a toxic agent causing serious
consequences to health, including various
sclerosis, Alzheimer's disease, myalgic
encephalitis, epilepsy, etc. without any proof
having ever been presented. On the other
hand, we know that certain allergies to
mercury are involved in the appearance of
lichenoid reactions, even if they are not the
only responsible cause. The very rare
epidemiological estimation of risk of allergy
gives us percentages that go from 0.04% to
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0.00001%. In this respect, the present data
concerning mercury are perfectly
characteristic of the risks of chronic
intoxication and of allergies caused by dental
therapies, i.e., extremely low (Ref. 11).
A third paper presented in the WHO
publication entitled ``Mercury Exposure
From Dental Amalgam Fillings:
Absorbed Dose and the Potential for
Adverse Health Effects'' stated: ``It is
concluded that no signs of renal toxicity
could be found in conjunction with
mercury released from amalgam
fillings.'' Additionally, the paper recited
the findings of a number of researchers
who conducted studies on human
subjects with symptoms allegedly
caused by amalgam fillings. One study
found that: ``No symptom group had a
higher estimated daily uptake of inhaled
mercury vapor, or any higher mercury
concentrations in blood and urine than
the control group.'' Another study
reported:
No significant differences regarding release
of mercury vapor [sic] from the amalgam
fillings before and after gum-chewing
between the test subjects and the matched
controls in a few spot measurements were
found. Furthermore, no significant
differences were found regarding urinary
mercury levels and total excretion of proteins
in urine. No damage in renal function was
noted.
Yet another study cited in the WHO
document found ``* * * no
correlation between the total number of
amalgam surfaces and fatigue, a
symptom described as a mercury
toxicity symptom'' (Ref. 11).
December 1998 marked the
culmination of a 2-year long study by an
ad hoc working group constituted by the
European Commission (the
Commission) on amalgam safety and
regulatory policies among the
Commission's 15 member states.
Comprised of leading dental
professionals, researchers, and
academics from western Europe, and
with oversight by the Commission's
medical devices expert group, the ad
hoc working group issued a
comprehensive assessment containing a
number of conclusions, as follows:
In recent years, toxicological and
biocompatibility aspects of dental amalgam
have been reviewed extensively, both
nationally and internationally, and risk
analyses carried out. Currently available data
indicate that mercury from dental amalgam
will not cause an unacceptable health risk to
the general population. * * * levels of
mercury found in tissues, blood and urine
and associated with dental amalgam fillings
are considerably below the levels at which
systemic dependent toxic effects have been
shown to occur * * *. The hypothesis that
there is a significant toxicological risk from
dental amalgam fillings cannot be
substantiated by the available evidence * * *.
Local reactions to dental amalgam fillings
and other dental restorative materials do
occur but are relatively rare * * *. There is
no scientific evidence that the use of dental
amalgam is related to adverse effects on preand
post-natal health or fertility.
Although there is not complete
unanimity within the world community
on either the potential health
consequences arising from the use of
dental amalgam or the appropriate
posture that national health authorities
should take with respect to regulating
its use, there is overwhelming
agreement among major health
authorities that have assessed these
risks that there is no evidence of a
serious threat to the general population
whose dental caries are treated with
amalgam (Ref. 11).
Notwithstanding general international
consensus about the level of risk, some
Nordic countries, such as Denmark,
Finland, Norway, and Sweden, have
placed legal restrictions on dental
amalgam for environmental concerns
(Refs. 7 and 11). In addition, several
European countries have taken very
conservative approaches.
V. 1993 and 1994 Panel Meeting
Concerning Encapsulated Amalgam
Alloy and Dental Mercury
The Dental Products Panel
(hereinafter referred to as the Panel) met
on December 1, 2, and 3, 1993, and June
29, 1994, to discuss amalgam products.
In addition to testimony from FDA staff,
the Panel heard testimony from
representatives of ADA, the American
Dental Trade Association, and PHS. The
Panel also reviewed the 1993 PHS
report and an updated literature review.
FDA requested that the Panel make a
classification recommendation only on
the encapsulated dental amalgam alloy
and mercury.
After considering this testimony and
information, the Panel unanimously
recommended to classify encapsulated
amalgam alloy and mercury for the
restoration of teeth into class II.
Specifically, the Panel recommended
voluntary performance standards that
could be issued by a group such as the
Association for the Advancement of
Medical Instrumentation (AAMI),
voluntary testing guidelines, education,
that the product be used only upon the
written or oral authorization of a
practitioner licensed by law to
administer or use the device, and that
the device be used only by persons with
training or expertise in its use (Ref. 12).
A. Identification
The Panel identified encapsulated
amalgam alloy and mercury as a device
composed of elemental mercury and
amalgam alloy separated by a septum,
which when placed in a dental
amalgamator produces dental amalgam
that is intended for the restoration of
teeth. This product is hereinafter
referred to in this document as
encapsulated alloy/mercury.
B. Classification Recommendation of
Encapsulated Alloy/Mercury
Class II (special controls): The Panel
recommended that the establishment of
special controls be a medium priority.
C. Summary of the Reasons for the
Panel's Recommendation for
Encapsulated Alloy/Mercury
The Panel, after considering the
persons for whom the generic device is
intended, and the proposed conditions
for use for the generic device, gave the
following reasons in support of its
recommendation to classify the
encapsulated alloy/mercury into class II.
1. General controls by themselves are
insufficient to provide a reasonable
assurance of the safety and effectiveness
of the device.
2. There is sufficient information to
establish special controls to provide
reasonable assurance of safety and
effectiveness.
3. Special controls will provide a
reasonable assurance of safety and
effectiveness.
D. Summary of Data on Which the
Panel's Recommendation Is Based
The Panel based its recommendation
on the review of the PHS report, other
published literature, on expert
testimony presented to the Panel, and
on the Panel member's personal
knowledge of, and experience with, the
devices. The PHS report has been
summarized under section IV.A of this
document.
The Panel also reviewed a wide range
of literature during its deliberation on
the classification of encapsulated alloy/
mercury in addition to the data
described in the PHS report. The
majority of the literature reviewed states
that there is no compelling reason to
change the current usage patterns of
dental amalgam. There is, however,
acknowledgement that continued
research in the area is prudent. The
following paragraphs describe specific
information detailing the literature.
One of the articles reviewed indicated
that mercury vapor is released from
amalgam restorations. This article stated
that there is release of mercury vapor
from restorations during chewing, tooth
brushing, and other oral activities. The
author, however, indicated that there is
insufficient knowledge about the
metabolism of mercury vapor in the
human to predict the health significance
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of chronic exposure to this source of
mercury (Ref. 13).
Another article reviewed by the panel
demonstrated that mercury vapor can be
analyzed in the oral cavity, especially
following removal of amalgams, and
during the setting and polishing of the
amalgam. This study also demonstrated
a significant direct correlation between
the size of the amalgam restoration and
the amount of vapor released. The
study, however, concludes that mercury
vapor exposure is of short duration and
infrequent and is well below the
exposure limits that are considered
harmful (Ref. 14).
Another article indicated that
although there is evidence of mercury
vapor released from amalgam
restorations there is no proof of a causal
link of this specific source of the heavy
metal to any major human health
problem (Ref. 15).
One article indicated that Dental
Amalgam remains one of the most
versatile restorative materials in use
(Ref. 16). The article further stated that
certain measures should be instituted to
assure patient and health care
professional safety. These include the
potential for chemical sensitivity to any
of the elements and compounds found
in dental amalgam. Similar concerns
were also raised in the PHS report. The
article reported that the chemical
sensitivity response to specific
compounds and elements in a dental
amalgam are no different than other
sensitivity reactions (Ref. 16). It further
stated that evidence suggests that
sensitivities to chemicals can occur
within a small portion of the
population.
Several articles addressed the benefits
versus the risks of dental amalgam, and
these articles agreed that, although
dental amalgam can release minute
amounts of elemental mercury,
occupational studies indicate that the
severity of response to this heavy metal
follows a dose response pattern (Refs. 16
and 17). A dose response effect has not
been demonstrated at a level of
exposure associated with dental
amalgams (Refs. 16 and 18). It also is
noted that mercury is absorbed from
many sources, including food and air,
and there has been no demonstration
that most people experience any clinical
effects from this small additional body
burden of mercury from amalgams (Ref.
16). The articles also stated that if there
are adverse health effects from mercury
in dental amalgam they may be so subtle
and nonspecific that they would be
difficult to detect, and noted that true
allergies to dental amalgam rarely have
been reported but do exist (Refs. 16 and
19).
One article directly examined the
claims of mercury poisoning from
dental amalgam (Ref. 19). This article
and others concluded that although it is
not possible to completely rule out
adverse effects in a minority of
susceptible patients, there is insufficient
evidence to justify claims that mercury
from dental amalgam restorations has an
adverse effect on health on the vast
majority of patients (Refs. 16 and 19).
Other articles indicated that, although
mercury vapor in high concentrations
can have deleterious effects on organ
systems, there is no evidence of risk at
the levels generated by chewing with
amalgam restorations (Refs. 13 and 15).
The regulatory issues related to
amalgam were addressed in one article.
This article emphasized the need for
continued surveillance and the need for
practitioner input to report problems in
performance with dental devices (Ref.
20).
E. Risks to Health
The Panel stated that there were no
major risks associated with
encapsulated amalgam alloy/mercury
when used as directed, but recognized
there was a small population of patients
that may demonstrate allergic reactions
to the materials in amalgam. The Panel
noted that improper usage of the
product also presented risks associated
with mercury toxicity. The Panel
specifically identified improper storage,
trituration, and handling as contributing
to this risk.
VI. The Proposed Rule
FDA is proposing classification
actions in this document for dental
mercury and dental amalgam products.
FDA believes that the uniform
regulation of all these products as class
II devices, and the application of certain
uniform special controls is appropriate,
given the same risks are presented by
the potential toxicity of mercury in each
of these devices. This approach is
consistent with the recommendation in
the PHS report to regulate these
products in a uniform manner. FDA
believes that sufficient information
exists to develop special controls, which
will provide reasonable assurance of the
safety and effectiveness of these devices.
With respect to encapsulated alloy/
mercury, FDA agrees with the Panel's
recommendation and is proposing that
this product be classified into class II
(special controls). Specifically, FDA is
following the Panel's recommendation
and proposing that labeling guidance
and relevant recognized voluntary
consensus standards be applied as
special controls to these products.
FDA is also proposing to reclassify
dental mercury as identified in
§ 872.3700 from class I to class II with
labeling guidance and a relevant
recognized voluntary consensus
standard as special controls.
Lastly, FDA is proposing to add
labeling guidance and a relevant
voluntary consensus standard as special
controls for the existing class II device,
amalgam alloy, as identified in §
872.3050. Currently, no performance
standard or other special controls are
designated for amalgam alloy.
A. Information FDA Reviewed Before
Issuing This Proposal
Before making this proposal, FDA
carefully examined extensive
information about the safety and
effectiveness of dental restorative
materials that contain mercury. As
stated previously, public concern about
the safety of dental amalgam
engendered several national and
international comprehensive reviews of
scientific information about the risks
and benefits of these products. FDA
examined the 1993 and 1995 PHS
reports, information presented to the
Panel and the Panel's recommendations,
information submitted in support of
citizen petition's requests, and
numerous reports of international health
organizations and foreign countries that
conducted comprehensive risk
assessments of dental products that
contain mercury.
In preparing the 1993 and 1995 PHS
reports described in section IV.A of this
document, the experts convened by the
PHS conducted a comprehensive review
of the scientific literature to assess the
benefits and risks posed by dental
restorative materials containing mercury
(Ref. 1). In assessing the benefits of
these products, the Benefits Assessment
Subcommittee performed a literature
search using the Medline system (Ref.1).
The scientific material reviewed for this
report included well-qualified,
prospective studies using objective
assessment methods; cross-sectional
studies reporting data for a given point
or points in time; retrospective studies
reporting the longevity of dental
restorations; and articles published in
peer-reviewed scientific journals (Ref.
1).
In assessing the risks associated with
dental restorative materials containing
mercury, the Risk Assessment
Subcommittee viewed the body of
significant literature that described the
evidence for possible health effects
produced from exposure to mercury
from dental amalgam (Ref. l). The Risk
Assesment Subcommittee reviewed an
extensive number of studies relating to
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possible risks presented by amalgam,
including studies relating to: Mercury
forms, intake, uptake, metabolism and
excretion; human exposure to mercury
from dental amalgam; factors affecting
estimates of daily intake of mercury
vapor from dental amalgam; intraoral
mercury vapor production and
estimation of daily intake; mercury
levels in body fluid; human and animal
uptake of mercury from dental amalgam;
hazard identification; human exposure
and response; occupational hazards
presented by dental amalgam exposure;
hypersensitivity; psychological
outcomes associated with mercury
levels in body fluids; and mercury
residues in neurological patients (Ref.
1). The PHS updated its review of
scientific literature on risks and benefits
and issued a new report in 1995 that
confirmed its initial findings (Ref. 2).
FDA also examined the information
reviewed by its expert Panel in 1994,
and the Panel's recommendation. In
making its recommendation, the Panel
reviewed the 1993 PHS report,
testimony from several professional and
health organizations, and additional
scientific literature as described in
section V.D of this document.
FDA also carefully examined
numerous studies, as described in
section IV.B of this document,
submitted by petitioners as evidence
that amalgam fillings cause detrimental
physiological and psychological effects.
Lastly, FDA reviewed the
comprehensive reports of several
international health organizations and
foreign countries on the risks associated
with these products, described in
section IV.D of this document. In
preparing these reports, these countries
and organizations conducted extensive
reviews and assessments of existing
literature and scientific information.
B. Weighing Benefits and Risks
For purposes of classification, FDA is
to determine the safety and effectiveness
of a device, in part, by weighing the
probable benefits to health from use of
the device against any probable risks of
injury or illness from such use (section
513(a)(2) of the act).
1. Benefits
Over the past 100 years, amalgam
fillings have provided great benefit by
restoring the structure of teeth of
millions of individuals. Products used
to make amalgam fillings are used today
in the following situations (Ref. 1):
• Individuals of all ages;
• Stress-bearing areas and in small to
moderate sized cavities in the posterior
teeth;
• Teeth with severe destruction of
structure;
• For cast-metal, metal-ceramic, and
ceramic restorations as a foundation;
• When a patient's commitment to
oral hygiene is poor; and
• When moisture control is
problematic with patients.
These products provide substantial
benefits over other dental restorative
materials because amalgam fillings offer
a broad range of applicability in clinical
situations, durability, ease of use and
relative insensitivity to variations in
handling technique and oral conditions
(Ref. 1).
2. Risks
Dental amalgam can release minute
amounts of elemental mercury, a metal
whose toxicity at high exposure levels is
well established. Estimates of human
uptake of mercury from amalgam
fillings have ranged between 1.24 and
27 micrograms (µg) per day, a factor of
more than twentyfold. However, the
widely varying experimental conditions
and assumptions in calculations
undoubtedly contribute to the wide
range of results. Non-physiologic-based
models resulted in estimates likely
being several times too high.
Recalculations correcting for these
factors produced estimates of less than
5 µg per day. Studies have demonstrated
higher blood and urine levels of
mercury in individuals with amalgam
fillings. However, estimates of mean
daily mercury exposure from all sources
vary (Ref. 1).
There is also evidence that mercury
levels in body fluids spike during
placement and removal of amalgam
fillings and then decline over time, but
no controlled clinical studies of health
consequences of this phenomenon have
been conducted. Occupational studies
indicate that subclinical effects may
occur at exposure levels tenfold higher
than those typically experienced by the
general population. Severity of response
generally follows a dose-response
pattern. There is no valid scientific
evidence demonstrating specific adverse
responses or a dose effect in humans at
levels of mercury exposure associated
with dental amalgam (Ref. 1).
Mercury is absorbed from many
sources, including food and air. Because
of the variability of exposures to
mercury from all sources in the
population, the margin of safety for
some persons may be lowered when
mercury from amalgam fillings is added.
There is no valid scientific evidence
that the general population treated with
dental amalgam experiences any
adverse clinical effects from this
additional body burden of mercury
arising from amalgam use (Ref. 1).
As stated previously, public concern
has been expressed over the toxic effects
of mercury from amalgam fillings and
certain persons have attributed a variety
of detrimental physiological and
psychological effects to mercury toxicity
from amalgam fillings. In response to
these concerns, numerous national and
international reviews have examined
reports of adverse effects from amalgam
fillings, and FDA has reviewed
substantial information about amalgam
risks, as described in sections IV and V
of this document.
After review of the scientific evidence
and review of numerous studies
submitted in support of banning or
upclassifying dental restorative
products containing mercury, FDA does
not find any persuasive evidence that
the physiological and psychological
symptoms attributed to amalgam fillings
are caused by amalgam fillings.
Furthermore, FDA does not find any
persuasive evidence that there is any
improvement of these symptoms after
removal of amalgam fillings. Although
there are studies purporting to support
the view that amalgam products pose
risks to persons beyond the small
subpopulation of hypersensitive
individuals, conclusions cannot be
drawn from these studies because they
are methodologically flawed.
This position concerning the evidence
of risks posed by amalgam fillings is
supported by the findings of the PHS
reports (Ref. l), international health
organizations, foreign governments, and
the recommendations of FDA's expert
advisory Panel as described in sections
IV and V of this document. FDA does
believe that there are some risks
associated with dental products used in
amalgam fillings from mercury toxicity
that are associated with improper
storage, trituration, and handling of the
product. However, FDA does not believe
that there are any major risks associated
with toxicity of mercury when these
products are used as directed. FDA
believes there are also risks of allergic
reaction to these products in a small
subpopulation of individuals.
3. Benefits Versus Risks
FDA believes that valid scientific
evidence, as defined in § 860.7(c)(2),
exists to determine the safety and
effectiveness of dental amalgam:
Namely, certain studies described in the
PHS report; the studies and reports
upon which the Panel based its
recommendation; studies and reports
reviewed by international health
organizations and foreign governments;
and most notably the significant human
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experience with amalgam for over 100
years.
Although the degree of risk is not
known to a certainty, FDA must make
an assessment to weigh the probable
benefits with the probable risks
associated with the use of the device, in
accordance with the criteria for a
reasonable assurance of safety under §
860.7(d)(1). The statute states that FDA's
classification decisions are to be
predicated on a ``reasonable assurance
of safety and effectiveness,'' not an
absolute assurance of safety and
effectiveness (section 513(a)(1) of the
act). Moreover, the statute directs FDA,
in determining what is a ``reasonable
assurance'' of safety and effectiveness,
to assess ``probable risk,'' not absolute
risk (section 513(a)(2) of the act). FDA
believes that the benefits and risks of
encapsulated alloy/mercury and
amalgam alloy are sufficiently
characterized to make a determination
that these products should be classified
into class II with special controls. FDA
notes that there is more significant
human experience with dental amalgam
than any other restorative material, and
that, accordingly, more is known about
the risks of dental amalgam than any
other restorative material (Ref. 1).
Given the known risks of untreated
caries, the longstanding history of
successful use of dental amalgam
restorations, the benefits of products
used in amalgam fillings over other
alternative materials, and the overall
lack of valid scientific evidence that
persons whose carious teeth are treated
with dental amalgam experience any
adverse health effects, other than a very
small number of people who are
hypersensitive to mercury, FDA believes
that the probable benefits of restorative
dental products containing mercury
outweigh the probable risks of using
these products.
The agency acknowledges that a small
subpopulation of persons that already
have high body burdens of mercury or
suffer from allergies may respond
adversely to the additional mercury
exposure from amalgam fillings. For
these subpopulations, the agency
believes the risks can be addressed by
labeling and by using alternative filling
materials.
FDA believes that special controls,
such as those described below by the
Panel, will address those risks presented
by dental amalgam products, both to
hypersensitive individuals and health
care workers, and that class II with
special controls will provide a
reasonable assurance of the safety and
effectiveness of dental amalgam
products.
4. Proposed Special Controls to Address
Risks Associated With the Use of Dental
Restorative Materials Containing
Mercury
FDA is proposing a labeling guidance
and relevant recognized voluntary
consensus standards as special controls
for dental mercury and dental amalgam
products. These special controls are
consistent with the Panel's
recommendations for special controls
for encapsulated amalgam alloy and
dental mercury, and FDA believes they
address the risks related to toxicity
associated with improper handling of
dental mercury and dental amalgam
products, and the risks for the small
subpopulation of individuals who are
allergic to ingredients in these products.
FDA's proposed guidance
recommends that dental amalgam and
dental mercury labeling lists all
ingredients. By doing so, the clinician
would be made aware of all materials
he/she is placing in a patient's mouth,
and would be able to avoid use of the
product if the patient had known
hypersensitivities to ingredients in
amalgam products. This guidance also
addresses risks to hypersensitive
patients by recommending labeling
instructing the practitioner not to use
these products in hypersensitive
persons, and of steps to take if allergic
reactions do occur. FDA believes the
guidance also controls the risks related
to toxicity from improper storage,
trituration, and handling by
recommending instructions for storage,
handling, and use. Finally, the guidance
describes the prescription labeling
requirements. FDA is including labeling
aspects of the current edition of ``ISO
1559:1995'' and ANSI/ADA's
``Specification No. 6–1987,'' described
below, into its labeling guidance.
The agency has adopted good
guidance practices (GGPs) regulation,
which set forth the agency's policies
and procedures for the development,
issuance, and use of guidance
documents (21 CFR 10.115). Elsewhere
in this issue of the Federal Register,
FDA is announcing the availability of
this draft guidance document for
comment in accordance with GGPs.
FDA is also proposing ``ISO
1559:1995 Dental Materials—Alloys for
Dental Amalgam'' as a special control
for both encapsulated alloy/mercury
and amalgam alloy. This standard was
developed by international
governmental and nongovernmental
committees in liaison with ISO, a
worldwide federation of national
standards bodies. The standard
describes appropriate specifications and
test methods for alloys composed
mainly of silver, tin, and copper used in
amalgam. The alloy may be in either
powder or tablet form, or in capsules
with portions of alloy and mercury. It
describes the minimum silver content
and the maximum content of tin,
copper, indium, palladium, platinum,
zinc, and mercury. It also describes the
recommended physical properties of the
alloy, specifically, maximum percent
creep, percent dimensional change, and
compressive strength after 1 hour and
after 24 hours. This standard also
describes the test methods for
determining physical properties. This
standard addresses consistency of
chemical composition and the
important physical properties of the
restorative material. This aspect of the
special control allows the practitioner to
know what substances are contained in
the product, which will allow the
practitioner to provide better counsel to
patients who are allergic.
The standard also addresses the risks
identified by the panel related to
improper storage, tituration, and
handling by providing
recommendations, specifications, and
instructions for proper handling,
storage, and tituration.
This standard also has packaging and
labeling instructions including a
recommendation to list elements
present in the alloy that are in
concentrations greater than 0.1 percent,
(see ISO 1559: 1995 section 7.2.1(f)).
These packaging and labeling
recommendations are consistent with
the FDA labeling guidance discussed
previously in all respects except one:
The recommendation concerning the
listing of ingredients. The specification
in ISO 1559:1995 section 7.2.1(f)
suggests listing only those elements
present in the alloy in concentrations
greater than 0.1 percent mass/mass (m/
m), whereas the FDA labeling guidance
recommends listing all ingredients in
the product labeling. FDA is not
incorporating this aspect of section 7.2.1
of ISO 1559:1995 as a special control
because it believes all ingredients, even
in concentrations smaller than 0.1
percent(m/m) could cause allergic
reactions in some subset of persons.
Therefore, FDA believes that
practitioners should be informed of all
ingredients. If practitioners are informed
of the ingredients they will be able to
counsel patients on appropriate
treatment options.
This standard may be obtained from
the International Organization for
Standardization, Case Postale, Geneva,
Switzerland, CH-1121. ISO also
maintains a site on the Internet at http:/
/www.iso.org.
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FDA is also proposing to adopt ANSI/
ADA's ``Specification No. 6–1987 for
Dental Mercury'' as a special control for
dental mercury (§ 872.3700) and
encapsulated alloy/mercury
(§ 872.3070). This standard specifies the
specifications and test methods for
mercury suitable for the preparation of
dental amalgam and provides
recommendations for packaging and
marketing. It recommends packaging in
air tight containers, and providing
hazard warnings regarding mercury
hygiene. This standard will allow the
dentist to be aware of the physical
properties of the mercury that will be
used for restorations that will enable the
dentist to better counsel allergic patients
and will alert the dentist to mercury
hygiene procedures. The risks identified
by the Panel, including toxicity
resulting from improper handling and
storage that may result in systemic
absorption of liquid mercury through
the skin, local chemical sensitivity
reaction, and inhalation of minute
amounts of mercury vapor, are
addressed in the standard by detailed
recommendations for mercury
manipulation and its packaging
information, transport and handling
procedures. This standard may be
obtained from ANSI/AAMI, 11 West 42d
St., New York, NY 10036. ANSI also
maintains a site on the Internet at http:/
/www.ansi.org.
VII. Environmental Impact
The agency has determined under 21
CFR 25.34(b) that this 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 environmental impact statement
is required.
VIII. Paperwork Reduction Act of 1995
FDA has tentatively determined that
this proposed rule does not contain any
new information collection
requirements and, therefore, clearance
by the Office of Management and
Budget under the Paperwork Reduction
Act of 1995 is not necessary.
IX. Analysis of Impacts
FDA has examined the impacts of the
proposed rule under Executive Order
12866 and the Regulatory Flexibility Act
(5 U.S.C. 601–612) (as amended by
subtitle D of the Small Business
Regulatory Fairness Act of 1996 (Public
Law 104–121)), and the Unfunded
Mandates Reform Act of 1995 (Public
Law 104–4). Executive Order 12366
directs 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). The agency
believes that this proposed rule is
consistent with the regulatory
philosophy and principles identified in
the Executive order. In addition, the
classification actions are not significant
regulatory actions as defined by the
Executive order. If a rule has a
significant economic impact on a
substantial number of small entities, the
Regulatory Flexibility Act requires
agencies to analyze regulatory options
that would minimize any significant
impact of a rule on small entities.
The agency certifies that these
proposed classification actions, if
finalized, will not have a significant
economic impact on a substantial
number of small entities. In addition,
this proposed rule will not impose costs
of $100 million or more on either the
private sector or State, local, and tribal
governments in the aggregate, and
therefore a summary statement of
analysis under section 202(a) of the
Unfunded Mandates Reform Act of 1995
is not required.
The proposed classification actions
will affect the three separate devices:
Dental mercury, amalgam alloy, and
encapsulated dental amalgam.
Professional dental groups have
recommended the use of encapsulated
dental amalgam over the other separate
products. According to FDA data,
encapsulated amalgam now accounts for
over 99 percent of the amalgam market.
Encapsulated dental amalgam is
typically purchased and stored in
packages of 80 capsules. These packages
are kept at hand in dental clinics until
needed. A typical restoration is
expected to require two capsules of
amalgam.
According to FDA records, there are
35 manufacturers of dental mercury,
amalgam alloy, and encapsulated dental
amalgam. In total, FDA expects that 40
distinct products will be affected by the
proposed classification actions. Over
200 million dental restorations were
performed during the last year for which
FDA has data (1999), of which 64
million utilized dental amalgam (ADA,
1999). There are currently
approximately 155,000 active dentists
operating in 145,000 separate clinics
(Bureau of Labor Statistics, 1998).
FDA is proposing to: (1) Issue a
separate classification regulation for
encapsulated amalgam alloy and dental
mercury; (2) amend the classification for
amalgam alloy by adding special
controls; and (3) reclassify dental
mercury from class I (general controls)
to class II. FDA is proposing that all
three products would have the same
labeling guidance as a special control. In
addition, FDA is proposing that dental
mercury would have a voluntary ANSI
standard as a special control,
encapsulated alloy and dental mercury
would have voluntary ANSI and ISO
standards as special controls, and the
amalgam alloy products would have a
voluntary ISO standard as a special
control.
FDA does not expect any change in
costs related to the voluntary standard
special controls. Manufacturers that
export encapsulated amalgam are
already responsible for meeting these
voluntary standards, and other
manufacturers currently follow
equivalent standardized methods. Any
change in performance test procedures
is likely to result in little, if any,
incremental change in production costs.
The special control labeling guidance,
however, would entail some minimal
costs to manufacturers. While some
manufacturer's products currently
include ingredient labeling, there is no
consistent industry format. FDA is
recommending a consistent label that
will allow interested consumers of
dental amalgam to easily obtain
necessary information that may result in
mercury exposure avoidance. Thus,
FDA believes that manufacturers of
these products will redesign their
labeling or develop for the first time
ingredient labeling as a result of these
proposed classification actions.
FDA has developed estimates of the
costs of enhanced labeling for dental
amalgam. This estimate is based on
costs developed by a consultant firm
(Eastern Research Group (ERG)) for
developing labeling for similar medical
devices, specifically medical gloves
(Ref. 21). These estimates include the
costs of artwork, design, regulatory
review, production, and application.
Overall, the cost of developing a new
label under these guidelines is
estimated to be $1,444 (or
approximately $1,500). FDA expects
that 40 labels will be developed, 1 label
for each product produced by the 35
manufacturers of the three devices.
Thus, the total cost of designing and
applying enhanced labels is expected to
equal $60,000 for 40 products. Over an
estimated 5-year useful life (based on
estimated cycle of labeling in the device
industry), the average annualized cost to
industry of this requirement (at 7
percent discount rate) is approximately
$15,000.
FDA does not expect the proposed
classification actions to affect dental
clinics.
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7629 Federal Register / Vol. 67, No. 34 / Wednesday, February 20,
2002 / Proposed Rules
FDA believes the costs of developing
new labeling (approximately $1,500) per
product are not significant for a
substantial number of small entities.
The dental instrument and supplies
industry, standard industrial code (SIC
3843) is typified by small
establishments. Only about 35 of the
approximately 650 establishments in the
industry have more than 100 employees.
(According to the Small Business
Administration, any entity with fewer
than 500 employees is considered small
for this industry). These establishments
are highly specialized (93 percent of
their shipments are in this industry
group) and concentrated (97 percent of
dental sales were from these
establishments). Total value of
shipments was estimated at $2.0 billion,
or about $125,000 per employee.
The Bureau of Census (Census) has
estimated that 12 percent of all industry
shipments come from dental
establishments with fewer than five
employees. Using the Census figures for
dental manufacturers that have fewer
than five employees, the average value
of their shipments would equal $1.25
million per year. The proposed
classification actions would result in the
design and application of enhanced
labeling, at a cost of $1,500 per product.
There are 35 manufacturers producing
40 products. Assuming one
manufacturer produces six products, the
costs for the manufacturer producing six
products would be $9,000 and the cost
for manufacturers producing one
product would be $1,500. The costs
would only be approximately 0.1
percent to 0.7 percent (less than 1.0
percent) of the expected revenues for an
extremely small entity. Thus, under to
the Regulatory Flexibility Act (5 U.S.C.
605(b)), FDA certifies that the proposed
regulations will not have a significant
economic impact on a substantial
number of small entities.
X. Request for Comments
Interested persons may submit to the
Dockets Management Branch (address
above) written or electronic comments
regarding this proposal by May 21,
2002. Two copies of any comments are
to be submitted, except that individuals
may submit one copy. Comments are to
be identified with the docket number
found in brackets in the heading of this
document. Received comments may be
seen in the office above between 9 a.m.
and 4 p.m. Monday through Friday.
XI. Effective Dates
FDA proposes that any final rule that
may issue based on this proposal
become effective 30 days after its date
of publication in the Federal Register.
XII. References
The following references have been
placed on display in the Dockets
Management Branch (address above)
and may be seen by interested persons
between 9 a.m. and 4 p.m., Monday
through Friday.
1. Dental Amalgam: A Scientific Review
and Recommended Public Health Service
Strategy for Research, Education and
Regulation; Public Health Service, U.S.
Department of Health and Human Services,
January 1993.
2. Update Statement by the U.S. Public
Health Service on the Safety of Dental
Amalgam, September 1, 1995.
3. Citizen petition Docket No. 93P–0424,
citizen petition Docket No. 94P-0354/CP1,
and citizen petition from Dr. Baylin et al.
4. Summary of the documented review of
scientific studies referenced in the dental
amalgam petitions, May 28, 1997.
5. Response to citizen petition Docket No.
93P-0424/CP1, letter to Robert E. Reeves,
Esq., dated October 31, 1997; response to
citizen petition Docket No. 94P–0354, letter
to Robert E. Reeves, Esq., dated November 10,
1997; and response to citizen petition
submitted to the National Institute for
Environmental Health Sciences referred to
FDA for reply, letter to Michael A. Baylin,
D.D.S. dated October 31, 1997.
6. Swedish National Board of Health and
Welfare, Possible Health Effects and Dental
Amalgam, 1994.
7. Dental Amalgam—A Report with
Reference to the Medical Devices Directive
93/42/EEC from an Ad Hoc Working Group
Mandated by the European Commission, June
1998.
8. The Safety of Dental Amalgam, Health
Canada, 1995.
9. Dental Amalgam and Human Health (A
Current Consensus); WHO Collaborating
Centre in Oral Health, Wellington School of
Medicine, University of Otego, Wellington,
New Zealand, June 1996.
10. The Safety of Dental Amalgam: A State
of the Art Review, Conseil d'Evaluation des
Technologies de la Sante' de Quebec, April
1997.
11. Consensus Statement on Dental
Amalgam, World Health Organization
Consultation on Assessing the Risks and
Benefit to Oral Health, Oral Care and
Environment Using Dental Amalgam and its
Replacement, March 7, 1997, draft.
12. Transcript from 1993 meeting of the
Food and Drug Administration Dental
Products (Advisory) Panel, December 1 to 3,
1993, and transcript from 1994 meeting of the
Food and Drug Administration's Dental
Products (Advisory) Panel, June 29, 1994.
13. Enwonwu, C. O., ``Potential Health
Hazard of Use of Mercury in Dentistry:
Critical Review of the Literature''
Environmental Research 42:257–274, 1987.
14. Haikel, Y. et al. ``Exposure to mercury
vapor during setting, removing, and
polishing amalgam restorations'' Journal of
Biomedical Materials Research 24:1551–
1558, 1990.
15. Mandel, Irwin D, ``Amalgam Hazards;
An Assessment of Research'' Journal of the
American Dental Association, 122:62–65
August 1991.
16. Corbin, Stephen B, ``The Benefits and
Risks of Dental Amalgam: Current Findings
Reviewed'' Journal of the American Dental
Association, 125:381–387, April 1994.
17. Mackert, J. R., ``Factors Affecting
Estimation of Dental Amalgam Mercury
Exposure from Measurements of Mercury
Vapor Levels in Intra-oral Expired Air''
Journal of Dental Research, 66 No. l2:1775–
1780, December 1987.
18. Mackert J. Rodway, ``Dental Amalgam
and Mercury'' Journal of the American
Dental Association, 122:61, August 1991.
19. Reinhardt, John W., ``Risk Assessment
of Mercury Exposure from Dental Amalgams''
Journal of Public Health, 48 No. 3, Summer
1988.
20. Jacobson, Elizabeth D., ``Regulatory
Issues in Dentistry: How Dentists Can
Participate'' Journal of American Dental
Associates, 4:444–50, April 12, 1994.
21. Eastern Research Group; ``Preliminary
Estimates: Labeling and Related Testing Costs
for Medical Glove Manufacturers,''
memorandum, January 18, 1999.
List of Subjects in 21 CFR Part 872
Medical devices.
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 part 872 be amended as follows:
PART 872—DENTAL DEVICES
1. The authority citation for 21 CFR
part 872 continues to read as follows:
Authority: 21 U.S.C. 351, 360, 360c, 360e,
360j, 371.
2. Section 872.3050 is amended by
revising paragraph (b) to read as follows:
§ 872.3050 Amalgam alloy.
* * * * *
(b) Classification. Class II (special
controls). The special controls for this
device are:
(1) International Standard ``ISO
1559:1995 Dental Materials—Alloys for
Dental Amalgam,'' and
(2) FDA's ``Special Control Guidance
for Industry on Encapsulated Amalgam,
Amalgam Alloy, and Dental Mercury
Labeling.''
3. Section 872.3070 is added to read
as follows:
§ 872.3070 Encapsulated amalgam alloy
and mercury.
(a) Identification. Encapsulated
amalgam alloy and mercury is a device
composed of elemental mercury and
amalgam alloy, separated by a septum,
which, when placed in a dental
amalgamator, produces dental amalgam
which is intended for the restoration of
teeth.
(b) Classification. Class II (special
controls). The special controls for this
device are:
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7630 Federal Register / Vol. 67, No. 34 / Wednesday, February 20,
2002 / Proposed Rules
(1) ``ISO 1559:1995 Dental Materials—
Alloys for Dental Amalgam,''
(2) ANSI/ADA's ``Specification No. 6–
1987 for Dental Mercury,'' and
(3) FDA's ``Special Control Guidance
for Industry on Encapsulated Amalgam,
Amalgam Alloy, and Dental Mercury
Labeling.''
4. Section 872.3700 is amended by
revising paragraph (b) to read as follows:
§ 872.3700 Dental mercury.
* * * * *
(b) Classification. Class II (Special
Controls). The special controls for this
device are:
(1) ANSI/ADA ``Specification No. 6–
1987 for Dental Mercury,'' and
(2) FDA's ``Special Control Guidance
Document on Encapsulated Amalgam,
Amalgam Alloy, and Dental Mercury
Labeling.''
Dated: February 7, 2002.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02–4028 Filed 2–19–02; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF THE TREASURY
Internal Revenue Service
26 CFR Part 1
[REG–209114–90]
RIN 1545–AH49
Golden Parachute Payments
AGENCY: Internal Revenue Service (IRS),
Treasury.
ACTION: Notice of proposed rulemaking
and notice of public hearing.
SUMMARY: This document contains
proposed regulations relating to golden
parachute payments to provide
guidance to taxpayers who must comply
with section 280G. Proposed regulations
under section 280G were previously
published in the Federal Register on
May 5, 1989 (the 1989 proposed
regulations). These proposed regulations
are proposed to apply to any payments
that are contingent on a change in
ownership or control occurring on or
after January 1, 2004. Taxpayers may
rely on these proposed regulations until
the effective date of the final
regulations. Alternatively, taxpayers
may rely on the 1989 regulations for any
payment contingent on a change in
ownership or control that occurs prior
to January 1, 2004.
DATES: Written or electronic comments
must be received by June 5, 2002.
Requests to speak and outlines of topics
to be discussed at the public hearing
scheduled for June 26, 2002, must be
received by June 5, 2002.
ADDRESSES: Send submissions to
CC:ITA:RU (REG–209114–90), room
5226, Internal Revenue Service, POB
7604, Ben Franklin Station, Washington,
DC 20044. Submissions may be hand
delivered Monday through Friday
between the hours of 8 a.m. and 5 p.m.
to: CC:ITA:RU (REG–209114–90),
Courier's Desk, Internal Revenue
Service, 1111 Constitution Avenue, NW,
Washington, DC or sent electronically,
via the IRS Internet site www.irs.gov/
regs. The public hearing will be held in
the IRS Auditorium, Internal Revenue
Building, 1111 Constitution Avenue,
NW, Washington, DC.
FOR FURTHER INFORMATION CONTACT:
Concerning the regulations, Erinn
Madden at (202) 622–6030 (not a tollfree
number). To be placed on the
attendance list for the hearing, please
contact LaNita M. Vandyke at (202)
622–7180.
SUPPLEMENTARY INFORMATION:
Background
This document contains proposed
amendments to 26 CFR part 1 under
section 280G of the Internal Revenue
Code (Code). Sections 280G and 4999 of
the Code were added to the Code by sec.
67 of the Deficit Reduction Act, Public
Law 98–369 (98 Stat. 585). Section 280G
was amended by sec. 1804(j) of the Tax
Reform Act of 1986, Public Law 99–514
(100 Stat. 2807), sec. 1018(d) of the
Technical and Miscellaneous Revenue
Act of 1988, Public Law 100–647 (102
Stat. 3581) and sec. 1421 of the Small
Business Job Protection Act of 1996,
Public Law 104–188 (110 Stat. 1755).
Section 280G denies a deduction to a
corporation for any excess parachute
payment. Section 4999 imposes a 20-
percent excise tax on the recipient of
any excess parachute payment. Related
provisions include section 275(a)(6),
which denies the recipient a deduction
for the section 4999 excise tax, and
section 3121(v)(2)(A), which relates to
Federal Insurance Contributions Act.
Proposed regulations (PS–217–84)
under section 280G were previously
published in the Federal Register at 54
FR 19390 on May 5, 1989 (the 1989
proposed regulations).
Explanation of Provisions
Overview
Section 280G denies a deduction to a
corporation for any excess parachute
payment. Section 4999 imposes a 20-
percent excise tax on the recipient of
any excess parachute payment. The
disallowance of the deduction under
section 280G is not contingent on the
imposition of the excise tax under
section 4999, and the imposition of the
excise tax under section 4999 is not
contingent on the disallowance of the
deduction under section 280G. For
example, an individual may be subject
to the 20-percent excise tax under
section 4999 even though the payor is
a foreign corporation not subject to
United States income tax.
Section 280G(b)(2)(A) defines a
parachute payment as any payment that
meets all of the following four
conditions: (a) The payment is in the
nature of compensation; (b) the payment
is to, or for the benefit of, a disqualified
individual; (c) the payment is
contingent on a change in the
ownership of a corporation, the effective
control of a corporation, or the
ownership of a substantial portion of the
assets of a corporation (a change in
ownership or control); and (d) the
payment has (together with other
payments described in (a), (b), and (c) of
this paragraph with respect to the same
individual) an aggregate present value of
at least 3 times the individual's base
amount. Section 280G(b)(2)(B) provides
that the term parachute payment also
includes any payment in the nature of
compensation to, or for the benefit of, a
disqualified individual if the payment is
pursuant to an agreement that violates
any generally enforced securities laws
or regulations (securities violation
parachute payment).
Section 280G(b)(1) defines the term
excess parachute payment as an amount
equal to the excess of any parachute
payment over the portion of the
disqualified individual's base amount
that is allocated to such payment. For
this purpose, the portion of the base
amount allocated to a parachute
payment is the amount that bears the
same ratio to the base amount as the
present value of the parachute payment
bears to the aggregate present value of
all such payments to the same
disqualified individual.

Generally, excess parachute payments
may be reduced by certain amounts of
reasonable compensation. Section
280G(b)(4)(B) provides that, except in
the case of securities violation
parachute payments, the amount of an
excess parachute payment is reduced by
any portion of the payment that the
taxpayer establishes by clear and
convincing evidence is reasonable
compensation for personal services
actually rendered by the disqualified
individual before the date of change in
ownership or control. Such reasonable
compensation is first offset against the
portion of the base amount allocated to
the payment.

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Brenda MINNER, Hillard Muttart, Linda Brennan and
James Brennan, Plaintiffs,<br><br>v.<br><br>AMERICAN
MORTGAGE & GUARANTY COMPANY, a Delaware Corporation, and
Emory Hill<br><br>Management Company, a Delaware
Corporation, Defendants.<br><br>No. C.A.
96C-09-263-WTQ.<br><br>Superior Court of Delaware.<br><br>April 17,
2000.<br><br><br><a
href=http://www.milesstockbridge.com/recent_developments/daubert5.htm
target=new>http://www.milesstockbridge.com/recent_developments/daubert5.htm</a>

You may have read many opinions including court
decisions.<br><br>Suggestion listen to real experts not some
speculations.<br><br><br>It is Mercury poisoning, but it is denied because of
liability.<br>Amalgam Illness: Diagnosis and Treatment <br> <br>A book
on how to cure mercury poisoning<br> What you can do
to get better <br> How your doctor can help <br> by
Andrew Hall Cutler, PhD, PE <br> ISBN 0-9676168-0-8
<br>Mercury poisoning fibromyalgia <br>chronic fatigue
chemical sensitivity <br>autism <br>hyperactivity
<br><br><a href=http://hometown.aol.com/noamalgam/
target=new>http://hometown.aol.com/noamalgam/</a><br><br>Amalgam Illness
<br>Diagnosis and Treatment <br> by
Andrew Hall Cutler, PhD, PE<br>ISBN 0-9676168-0-8

Please
check:<br><br><a href=http://www.melisa.org
target=new>http://www.melisa.org</a><br><br><a
href=http://www.melisa.org/articles/index.html
target=new>http://www.melisa.org/articles/index.html</a><br><br><a
href=http://www.melisa.org/articles/neuroen.pdf
target=new>http://www.melisa.org/articles/neuroen.pdf</a><br><br><a
href=http://www.melisa.org/articles/biomark.pdf
target=new>http://www.melisa.org/articles/biomark.pdf</a><br><br><a
href=http://www.melisa.org/articles/nialler.pdf
target=new>http://www.melisa.org/articles/nialler.pdf</a>

From what i have read, fibro has been linked
almost a hundred percent with sleeping disorders. You
wake up feeling tired and sore, hardly able to feel
good the whole day. And the test for fibro includes
checking the joint locations where the tendons of large
muscles connect to the bone in the arms, back, neck and
legs. Oddly these locations are also the joints that
lock up at night to protect us from harming ourselves
in our sleep.<br>So i wondered, why would that be?
<br>Well, i have low blood sugar, a condition that doctors
no longer believe in. They are taught now that
hypoglycemia just does not exist as its own diesease and if it
does its extremely rare.<br>Ha! double HA!<br>As soon
as i started taking natural herbs for my low blood
sugar, my sleep became wonderful. And I stopped feeling
sore in my joints where they lock up at night. My body
feels thicker, more muscled as though they finally have
food to heal themselves.<br>Then it occured to me,
what if my fibro was caused because my low blood sugar
made my muscles burn the secondary sugars, and created
lactic acid like as though i was a runner who gets his
second wind, but has painful muscles the following
day.<br>Anyway, before you should look into herbs that raise
blood sugar, make sure you are low. Get a doctor to
check it, mine hangs aroung the 65 mark, and can get
lower. It is said that this is in a normal range. That
may be true for some, but it was not for me. My body
needs more fuel.<br>The only herbs i am trusting at the
moment are ginger root, a tiny piece, chewed, and
dandelion root, no leaves or stalk, which are not safe for
everyone. The root is taken in small amounts too, a tiny
piece, and red pepper on my food, and chromium
picholate, a suppliment that so far, i have not felt a
difference with. But the roots and pepper above, sure made a
difference. I take them twice a day, at lunch time and at bed
time.<br>Please, if you have fibro, please make sure you check
your blood sugars before doing this. If your blood
sugars are always over a hundred, dont even try
this.-love, allen roberts. 1-870-886-2963.

Kath, I am enclosing a link that may help answer
your questions regarding the mercury
fillings.<br><br><br><a href=http://www.ic-hope.com/
target=new>http://www.ic-hope.com/</a><br><br>This site belongs to
Cath767@.... She has written
2 books so far about her battles with IC. She is in
remission now and has been for quite a few years. I'm sure
you could email her with any questions. I read her
first book and found it very informative. She believes
in a more natural approach to IC. I hope this helps
you a little bit.<br>Healing hugs,<br>Lorraine

I'm 43 years old. I started having anxiety and
depression when I was 7. I had lots of cavities and I know I
had fillings at that age. Our dentist got rich off
all the fillings he put in my mouth and frankly I've
always wondered if I needed so many, but what is a
little kid to do? Question the dentist?<br><br>For the
last 10 years I've had fibromyalgia, chronic fatigue
syndrome, neck and shoulder pain & muscle knots, TMJ
syndrome, and still suffering with anxiety, phobias and
depression.<br><br>I ran across some liturature on the mercury in our
mouths and how it goes to our brains, etc. This makes
perfect sense to me, but my family thinks I'm wacko.
After all, why would they keep giving people mercury
amalgam fillings if they were so dangerous?<br><br>Has
anybody had their fillings removed? Did you feel better?
Did you detox your body?<br><br>Just wondering. I
know I'm not crazy.<br><br>Kath

Additional Symptoms: <br><br>Has developed cold
intolerance and has cold hands and feet most of the time. She
is clumsy at times. At times has confusion,
decreased concentration and decreased memory. Her moods can
change quickly and often bursts into tears. Her heart
will beat rapidly at times for no apparent reason.
Since the hepatitis shot develops shortness of breath
at rest and sometimes with exertion. No urinary
symptoms.<br><br>Investigations: <br><br>Has seen her family doctor many times
with numerous investigations done including blood
work, chest x-ray, E.C.G. etc. all being normal. Her
family doctor suggested that she was depressed and
required antidepressant medication. Saw a naturopath who
apparently told her that she had inflammation in her heart,
pancreas, and kidneys. She was taking a multitude of
supplements including vitamins, minerals, and herbal
products. <br><br>Physical Exam: <br><br>Appears generally
well <br>BP 100/70, Pulse 80 and regular. <br>Head and
Neck, Chest, and Cardiovascular exams normal, <br>No
dental amalgams visible <br>Abdominal exam reveals
tenderness over colon region. <br>Musculoskeletal exam
reveals 13 out of 18 tender points positive. <br>Hands
and feet are cold to touch. <br>Nervous System exam
reveals brisk reflexes and abnormal balance while
standing with eyes closed. <br> <br><br>DMPS Challenge
Test: (This test involves injecting DMPS intravenously
over 20 minutes. Urine is then collected over 1 1/2
hours and then sent to toxicology lab in Chicago.)
<br><br>The following results were obtained: <br><br>Cadmium
and Lead slightly elevated with small amounts of
Arsenic and Nickel present. <br>Mercury is approximately
20 times higher than the normal reference range.
<br>VIEW TABLE SHOWING URINE TEST RESULTS<br><br>
<br><br>Treatment: <br><br>She agreed to go through the Mercury
Detoxification Program and took a series of DMPS injections
followed by intravenous vitamin/trace mineral infusions
within 48 hours. <br>A second DMPS challenge test
revealed urinary mercury excretion down by 50 percent with
evidence of Arsenic, Cadmium, Lead, and Nickel still being
excreted in high quantities. <br>After her fourth
treatment: <br>she noticed that her headaches had
disappeared. <br>her energy was improving substantially
<br>and the pain in her bones and muscles was decreasing
significantly. <br>she still had shortness of with climbing
stairs, but was able to exercise 20 to 30 minutes on a
glider machine. <br>By her sixth treatment: <br>her
energy was much better <br>the pain in her joints and
muscles had disappeared. <br>as well, she had no more
shortness of breath with exerting herself. <br>By her
seventh treatment: <br>she told me that her dizziness had
resolved. <br>By her eighth treatment: <br>she said that
she was back to her normal self. <br>she had noticed
she was able to sleep all night without waking up
frequently. <br>By her ninth treatment: <br>she told me that
she felt "great" and that she was working-out five
days per week at the gym. <br>post-exercise muscle
pain and fatigue had disappeared. <br>By her tenth
treatment: <br>she told me that she felt completely well,
<br>all of her symptoms had disappeared, <br>she was
sleeping better than she had in 20 years. <br>as well, she
was able to tolerate many more foods without
reactions. <br>Case Summary<br><br>This is an excellent case
that demonstrates many of the symptoms which we have
observed to be commonly associated with mercury toxicity.
Once evidence was available through definitive testing
to verify that the patient was contaminated with a
significant body burden of mercury and other toxic metals,
the basic treatment was relatively straightforward.
Most patients we see with fibromyalgia respond
significantly to heavy metal detoxification. This is in keeping
with the experience of scientists in this field in the
U.S. as well as in Germany.

Fibromyalgia and Myofascial Pain
Syndromes<br><br>CASE HISTORY NO. 1: Fibromyalgia <br><br>A 49 year old
Caucasian woman presented with: <br><br>blood sugar level
problem (frequent episodes of reactive hypoglycemia)
<br>underactive thyroid <br>shortness of breath <br>frequent
episodes of dizziness <br>long standing debilitating
insomnia <br>extreme fatigue and exercise intolerance
<br>extensive and migratory pain throughout her body <br>could
not lose weight even on very low calorie diets
<br>various digestive problems and symptoms suggestive of
irritable bowel syndrome <br>On reviewing her
questionnaires and taking a detailed medical history the
following pertinent points were ascertained: <br><br>Muscle
Pain: <br>migrating pains in various muscles over the
years. She would wake-up with stiff, sore muscles in the
mornings. The pain was often worse following exercise.
<br>Joint pain: <br>this would occur mostly in finger
joints. No swelling noted. Would awaken with joint
stiffness in the morning. <br>Fatigue: <br>would wake-up
unrefreshed in the morning. Profound fatigue present all day.
Present for several years, much worse after hepatitis
shot one month before presenting to me. Exertion would
make this worse for days. Used to work out at the gym
several days per week now walking up one flight of stairs
is taxing. <br>Insomnia: <br>for greater than 20
years she awakened frequently during the night. Over
the past few months poor sleep initiation as well.
<br>Disordered Bowel Function: <br>trouble with chronic
constipation despite adequate thyroid replacement. Exercise,
herbal products, and increased fluid intake help
somewhat. Often has lots of mucus in the stools.
<br>Headaches: <br>has the occasional migraine headache. Tension
headaches for many years being more frequent since the
hepatitis shot. Usually resolves by taking aspirin.
<br>Sensitivity To Light: <br>eyes very sensitive to bright light
and must wear sunglasses most of the time.
<br>Numbness: <br>for a long time has had intermittent
numbness/tingling of the left forearm and hand. Chiropractic
treatments of some benefit. <br>Food Sensitivities: <br>for
many years has experienced various reactions to
certain foods. Over the previous six months this has
become much worse and the number of foods that she can
tolerate is very few. She reacts to numerous foods by
developing abdominal bloating, diarrhea, and increased mucus
in stools. Often will get headaches and changes in
cognition. As well, she craves sweets, has frequent
hypoglycemic episodes, and is distressed about weight gain.
She has a low tolerance to alcohol ingestion.
<br>Mercury Exposure: <br>she recalled that all of her teeth
were filled with "silver" (mercury) fillings since
childhood. Over the years has had the fillings changed to
composites. The last dental work done one year ago and she
had five amalgams changed over a six-week period
without cautionary protocols being followed. <br>Past
Medical History: <br><br>Surgery: <br>Tonsillectomy,
hysterectomy, a few D&Cs. <br><br>Medical: <br>Hypothyroid,
post menopausal, hypoglycemia, peptic ulcer disease
(in past), right kidney stone, depression in her 20s
treated with medication.<br><br>Family History:
<br><br>Father-has insulin dependent diabetes mellitus, previous
myocardial Infarction, and insomnia. Mother- died at 62
years old of a myocardial infarction. Had previous
myocardial infarction. Brother- unknown health history
Sister-insulin dependent diabetes mellitus-leg amputation at 52
years old. Previous myocardial infarction. Sister-died
at 37 years old during heart surgery.
<br><br><a href=http://www.oceansidemedicine.com/clinical_cases/fibromyalgia.htm
target=new>http://www.oceansidemedicine.com/clinical_cases/fibromyalgia.htm</a>

<a href=http://www.vaccineinfo.net/autismHg.htm
target=new>http://www.vaccineinfo.net/autismHg.htm</a>

See: <a href=http://www.toxicteeth.net target=new>http://www.toxicteeth.net</a>
read it
all!<br><br>It is already
comming!<br><br>Also:<br><br><a
href=http://clubs.yahoo.com/clubs/adentalmercuryamalgam
target=new>http://clubs.yahoo.com/clubs/adentalmercuryamalgam</a><br><br><a
href=http://clubs.yahoo.com/clubs/amalgamclassaction
target=new>http://clubs.yahoo.com/clubs/amalgamclassaction</a><br><br>WE ARE
GOING TO WIN soon or later (not to much $$$$
considering QUACKERY in US!)

nothing will ever come of this case don't hold your breath no one will gain!

"I'm sorry what am I missing and what does this
<br>mercury in the teeth have to with fibro or
myofacial?"<br><br><br>As simple as it is:<br><br>Simply you are missing a
working BRAIN!<br><br>Next time try to use it as per
instructions from above !

ROOT CANALS !<br>FLUORIDATED WATER & TOOTHPASTE!<br><br><a
href=http://hometown.aol.com/Rjj5019/index.html
target=new>http://hometown.aol.com/Rjj5019/index.html</a>

Legal brief filed in 1995 by attorneys for the
ADA in W.H. Tolhurst vs. Johnson and Johnson Consumer
Products, Inc.; Engelhard Corporation; ABE Dental, Inc.;
the American Dental Association, et al., in the
Superior Court of the State of California, in and for the
County of Santa Clara, CA, Case No.
718228.<br><br><br><a href=http://www.davidmillerdds.com/holistic.htm
target=new>http://www.davidmillerdds.com/holistic.htm</a><br><br><br>"The ADA
owes no legal duty of care to protect the
public from allegedly dangerous products used by
dentists. The ADA did not manufacture, design, supply or
install the mercury-containing amalgams. The ADA does not
control those who do. The ADA's only alleged involvement
in the product was to provide information regarding
its use. Dissemination of information relating to the
practice of dentistry does not create a duty of care to
protect the public from potential injury".

I suggest that you ask any killer if he is guilty
of killing, all will tell tou that are
innocent.<br><br>If rheumathologist tells you that mercury is the
cause he will be unemployed and could loose his
licence.<br><br>You can not be allergic to metal!<br>The alleged
allergic mecanism is based on IgE and production of
histamine. Metals DO NOT produce reactions related to
histamine, it however has severe autoimmune activities. Even
research are being poliicized.<br>Metal pathology is due
to neurotoxic not allergic mechanism as frequently
deceiving in literature. One can develop sensitivity not
allergy to metals. <br>Mercury poisoning from dental
fillings is responsible for such chronic diseases which
include, multiple chemical sensitivity (MCS), chronic
fatigue syndrome (CFS), Fibromyalgia syndrome (FMS),
Carpal Tunel, Erectile Dysfunction disorder, Gulf War
Illness, alleged menopause, and the vast group of
autoimmune disorders. <br><br>Finally what the
rheumathologist know about medicine? How to push drugs for
pharmaceutical company? We have to many uneducated quacks
practicing medicine!<br><br><br>Allergy is misinterpreted as
ANY ADVERSE
reaction.<br><br><a href=http://www.melisa.org/nl2099.html
target=new>http://www.melisa.org/nl2099.html</a><br><br>DOH State site:
<br><a href=http://www.state.hi.us/health/eh/heer/poison.html
target=new>http://www.state.hi.us/health/eh/heer/poison.html</a><br><br>The
allergies by the latest study are caused
by:<br><br><a href=http://www.newswise.com/articles/2000/5/ALLERGY5.JHM.html
target=new>http://www.newswise.com/articles/2000/5/ALLERGY5.JHM.html</a><br><br>\
AMA:
<br><br><a href=http://jama.ama-assn.org/issues/v283n24/ffull/jqu00004-4.html
target=new>http://jama.ama-assn.org/issues/v283n24/ffull/jqu00004-4.html</a><br>\
<br>Finally you have here plenty to read and think
about:<br><br><a href=http://www.cfspages.com/
target=new>http://www.cfspages.com/</a> <br><br>Integrated Defense System
Overlaps as a
Disease Model: With Examples for Multiple Chemical
Sensitivity<br><a href=http://www.herc.org/news/mcsarticles/rowat.htm
target=new>http://www.herc.org/news/mcsarticles/rowat.htm</a><br><br><br><a
href=http://www.vimy-dentistry.com/
target=new>http://www.vimy-dentistry.com/</a><br><br>"he also told me chellation
or? is a
mith"<br><br>Have heard plenty of BS from QUACKS teaching and
Quacks graduating from medical schools in US
!<br><br>You may argue ... but at the end you are the one who
suffers.... because you are trusting those who deliberatelly
deceive you with big money behind ....SPECIAL INTERESTS!

I guess you must be right i asked my
rheumatologist about the murcury and he said there is no medical
proof. I have been told to have white fillings by my
dentist because Im allegic to metal. he also told me
chellation or? is a mith .

I'm not sure what you mean. I have stayed on
vioxx and also I take tyonal with codeine I get from
canada it has been helping especially at work. My doctor
said its fine and my pharmacist said there is no
problem taking with vioxx.

<a href=http://www.sover.net/~devstar/
target=new>http://www.sover.net/~devstar/</a><br><br>Myofascial
trigger points can be identified and documented
electrophysiologically by characteristic spontaneous electrical activity
(SEA). They may also be identified histologically (which
means that the structure of the cells have changed) by
contraction knots-- the lumps and bumps we know only too
well. Both of these phenomenon seem to result from
excessive release of the neurotransmitter acetylcholine
(ACh) from the nerve terminal of the motor endplate
(the complex end formation of the nerve).<br><br>Even
experts have problem with causation.<br><br>Fibromyalgia
&<br>Chronic Myofascial Pain Syndrome<br>(FMS & CMPS)<br>We
have many requests for the physician's side symptoms
list, known as "Devin's Diagnostic"<br> <br><br>This
site describes two medical conditions which often
occur together: Fibromyalgia and Chronic Myofascial
Pain . Chronic Myofascial Pain was previously called
Myofascial Pain Syndrome. See the handout "Myofascial
Pain--A Neuromuscular Disease".

Amalgam Illness: Diagnosis and Treatment <br>
What you can do to get better <br> How your doctor can
help <br> by Andrew Hall Cutler, PhD, PE <br> ISBN
0-9676168-0-8 <br><br>And Andy is damn
right!<br><br><br>Amalgam Illness: Diagnosis and Treatment starts with a
detailed explanation of why to consider amalgam illness to
be something that some people must have by comparing
the well known statistics for how much mercury people
absorb from their fillings to the well known statistics
of how sensitive different members of a population
are to a given toxin. This is for people who really
don't know if they believe in amalgam illness or not
(the other material available is rather sensational
and I can't blame anyone reading it for having
questions) before going any further. <br><br> Amalgam
Illness: Diagnosis and Treatment discusses how to deal
with physicians if you think you have a controversial
disease - especially if you have the great "luck" to be
covered by a managed care plan. <br><br>This book
explains how the modern epidemic of disabling, incurable
chronic diseases is due to unrecognized mercury
poisoning. Many conditions, from Parkinson's disease and
autism - widely recognized as terrible afflictions - to
those like chronic fatigue and fibromyalgia which,
though equally serious, are disparaged as "Yuppie flu"
can be undiagnosed mercury poisoning. The book
explains WHY mercury poisoning is so widespread, yet
seldom diagnosed. Proper diagnostic procedures are given
so that sick people can decide what is wrong rather
than trying random treatments. This book explains how
to cure chronic mercury poisoning, what to do to
control the problems it causes, and provides the real
technical information needed for diagnosis and treatment in
a straightforward manner. This down to earth book
lets patients take care of themselves. It also lets
doctors who are not familiar with chronic mercury
intoxication treat it. The book is a practical guide to
getting well. <br><br>Mercury can cause a bewildering
variety of problems. In fact, one of the major criticisms
of amalgam illness is that it is cited as the cause
of so many things. But, like the parable of the
blind men and the elephant, mercury can indeed cause
many diseases. Modern physicians are not trained to
find the root cause of a sick person's problems. They
are trained to translate what they see into latin,
look it up in their textbook, and apply a cookbook
treatment. With a toxin that poisons fundamental metabolic
processes different people will experience different
symptoms to start off, depending on their own individual
biochemistry. As the poisoning becomes more and more serious,
further symptoms surface and the modern doctor adds more
diagnoses - a patient who starts with depression might
later be considered to have hypothyroidism, allergies
and asthma in addition. But no thought is given to
why one person should develop more and more
"diseases," when a single diagnosis - chronic mercury
poisoning - could account for them all. <br><br> This is
not the first time in the history of modern medicine
that a very obvious disease was belittled and ignored.
Until recently it was believed that ulcers were
entirely psychosomatic. Ulcer sufferers underwent
prolonged treatment, were seldom cured, and often ended up
under the surgeon's knife. After years of intense
criticism and ridicule - about 20 years after the research
was published - it has finally been accepted that
most ulcers are due to helicobacter pylorii infection
which can be easily cured with appropriate antibiotic
therapy. At least by the medical schools and licensing
boards. Yet it is still common to find physicians who
still treat ulcers by prescribing acid suppressors - as
if they resulted from too much stomach acid.
<br><br>Mercury in the brain doesn't only cause neurological
symptoms - but since the brain controls hormones and the
immune system, everything in the body can be effected
from having mercury in the brain.

<a href=http://hometown.aol.com/noamalgam/
target=new>http://hometown.aol.com/noamalgam/</a>

"Hello,I just found out last month that I now
have this myofacial in my jaw and it is prue hell with
the pain.Nights staying up because of the pain and
the oral denist said I need to have all my teeth
pulled to releave the pain and get false teeth because
were I was in a car wreak both sides of my jaw was
broken so now I have this in my mouth and it's not any
fun at all."<br><br><br>Your "dentist" is a typical
scam artist and a con if not an idiot!<br><br>Get a
real one, who is a little more intelligent, or you
will suffer more for ever.<br><br>Crap
flies!<br><br>You may have nerve damage as result of injury and
butchered surgery.<br><br>It is not likely fibromyalgia or
myofacial syndrome!<br><br>You have what is undisputed
neural pain!<br><br>Try to get injection of anestethic
and you will relize that it is caused by a damage to
nerve.<br><br>"myofacial" does not mean it is ... face related!

It is a classic question of people whoi do not
understand neurotoxicity and poisoning of neural systems
(the fascia (the sheath around a
muscle)).<br><br>Mercury is the most potent neurotoxin attacking your
nervous system, and neurotransmission.<br><br>myofacial
has nothing to do with face!<br>Myofacial is
hardening (lubricating) of gell surrounding the nerve and
muscle tissue .<br><br>Unfortunatelly many cons in
medical profession are selling snake oil!<br><br>Same
applies to Carpal Tunel - poisoning by mercury - not
repetitive stress as fraudulaently claiming!<br><br>Keep in
mind that medical reatments scams by American Medical
association ans American Dental Association is a billion
dollars industry and have nothing to do with
science.<br><br>You were lied and misinformed by those who either do
not know either do it for profit.<br><br>Fibromyalgia
/ myofacial syndrome is poisoning by mercury
neurotoxicity, and altered neurotransmission.<br><br>The pain is
neural due to mercury neurotoxicity - it is as simple.

The diference is that I am an expert on
fibromyalgia and the quacks are not.<br><br>Don't argue listen
and if you want to be helped follow,
.....<br><br>Listening to quacks in business youi are playing russian
roulette.

I'm sorry what am I missing and what does this
<br>mercury in the teeth have to with fibro or myofacial?It
comes from trma and abuse etc.Now the myofacial comes
from myself having my jaw broke on both sides and that
made the fibro go into my face witch they call
myofacial?

I'm so very sorry to hear about your pain and all
my prayers are with you and your family.<br>It's
very hard to loose a loved one but just be strong and
God will Do Whats Best.<br> seaside24184

I'm unsure were you got all your information
about the fibromyalgia but I feel that you are way off
tack and for some people the medicine helps out a
great deal.I have done alot of rescreach on this
disorder and yes the medicine also does make peole
worse.Stay away from stress and take care of yourself,eat
the right food and stay in shape don't let life bring
you down and the fibro frog want be as bad.<br>Just
the way that I feel and has helped me out.

Hello,I just found out last month that I now have
this myofacial in my jaw and it is prue hell with the
pain.Nights staying up because of the pain and the oral
denist said I need to have all my teeth pulled to
releave the pain and get false teeth because were I was
in a car wreak both sides of my jaw was broken so
now I have this in my mouth and it's not any fun at
all.So I wonder if this will really help I know that it
want go away only help the pain ease off a
little.<br>Does anyone have any thoughts of my problem or know
how to ease the pain?Does anyone else have the same
problem?<br> seaside

I have just learned of the amalgam filling which i have many some replaced not
all. lucy dasans

I'm having my amalgam fillings replaced this August.  I've been symptom-free
since October 2000.  Please read my story at <a href=http://turn.to/truehealth
target=new>http://turn.to/truehealth</a>