Hi, the dentist I use does not do mercury fillings...

I am glad I found him..

Hugs, Rita

--- In fibromyalgiaandmyofacial@y..., airc0mbat <no_reply@y...> wrote:
> We need your comments to FDA to BAN "silver" mercury
fillings!
>
> ACT NOW!
>
>
> Reference PDF file
>
> http://www.fda.gov/OHRMS/DOCKETS/98fr/022002a.pdf
>
>
>
>
> 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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> 2002 / Proposed Rules
> 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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> 2002 / Proposed Rules
> 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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> 2002 / Proposed Rules
> 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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> 7628 Federal Register / Vol. 67, No. 34 / Wednesday, February 20,
> 2002 / Proposed Rules
> 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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