#3 ~ FDA: Dental Devices: Classification of Encapsulated Amalgam Alloy and Dental Mercury and Reclassification of Dental Mercury; Issuance of Special Controls for Amalgam Alloy 
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 #3 ~ FDA: Dental Devices: Classification of Encapsulated Amalgam Alloy and Dental Mercury and Reclassification of Dental Mercury; Issuance of Special Controls for Amalgam Alloy

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 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availability of this draft guidance document for comment in accordance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.***.com/ .

[[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.***.com/ .

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 {*filter*}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 {*filter*}
Health, {*filter*}Care and Environment Using Dental Amalgam and its
Replacement, March 7, 1997, draft.
    12. Transcript from 1993 meeting of the cooking.net">food and Drug
Administration Dental Products (Advisory) Panel, December 1 to 3,
1993, and transcript from 1994 meeting of the cooking.net">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-{*filter*}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 cooking.net">food and {*filter*}, 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



Wed, 11 Aug 2004 03:25:57 GMT
 
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