[Federal Register Volume 67, Number 34 (Wednesday, February 20, 2002)]
[Proposed Rules]
[Pages 7620-7630]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-4028]


 ========================================================================
 Proposed Rules
                                                 Federal Register
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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.
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 

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

[[Page 7620]]



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.

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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 single-use 
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availability for comment of a draft guidance document that is proposed 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.

[[Page 7621]]

 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 Sec. 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 Sec. 872.3700 (21 CFR 872.3700) being regulated as a 
class I device and amalgam alloy Sec. 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 (Sec. 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 
(Sec. 872.3700) and amalgam alloy (Sec. 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 
(Sec. 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

[[Page 7622]]

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 long-term, 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

[[Page 7623]]

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 
dose-dependent 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 mercury-containing 
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

[[Page 7624]]

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 pre- and 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

[[Page 7625]]

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 
Sec. 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 Sec.  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

[[Page 7626]]

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 (g) 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 g 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 
Sec. 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

[[Page 7627]]

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 Sec.  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.

[[Page 7628]]

    FDA is also proposing to adopt ANSI/ADA's ``Specification No. 6-
1987 for Dental Mercury'' as a special control for dental mercury 
(Sec. 872.3700) and encapsulated alloy/mercury (Sec. 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.

[[Page 7629]]

    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:


Sec. 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:


Sec. 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:

[[Page 7630]]

    (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:


Sec.  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