[Federal Register Volume 73, Number 82 (Monday, April 28, 2008)]
[Proposed Rules]
[Pages 22877-22879]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 08-1187]



Food and Drug Administration

21 CFR Part 872

[Docket No. FDA-2008-N-0163] (formerly Docket No. 2001N-0067)

Dental Devices: Classification of Encapsulated Amalgam Alloy and 
Dental Mercury and Reclassification of Dental Mercury; Issuance of 
Special Controls for Amalgam Alloy; Reopening of Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule; reopening of comment period.


SUMMARY: The Food and Drug Administration (FDA) is reopening for 90 
days, the comment period for the proposed rule, published in the 
Federal Register of February 20, 2002 (67 FR 7620), on the 
classification of encapsulated amalgam alloy and dental mercury, the 
reclassification of dental mercury, and the issuance of special 
controls for amalgam alloy. In the Federal Register of July 17, 2002 
(67 FR 46941), the initial comment period was reopened for 60 days. The 
agency is taking this action to provide the public with an additional 
opportunity to comment and to request data and information that may 
have become available since publication of the proposed rule.

DATES:  Submit written or electronic comments by July 28, 2008.

ADDRESSES: You may submit comments, identified by Docket No. FDA-2008-
N-0163 (formerly Docket No. 2001N-0067), by any of the following 
Electronic Submissions
    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments.
Written Submissions
    Submit written submissions in the following ways:
     FAX: 301-827-6870.
     Mail/Hand delivery/Courier [For paper, disk, or CD-ROM 
submissions]: Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
    To ensure more timely processing of comments, FDA is no longer 
accepting comments submitted to the agency by e-mail. FDA encourages 
you to continue to submit electronic comments by using the Federal 
eRulemaking Portal, as described previously, in the ADDRESSES portion 
of this document under Electronic Submissions.
    Instructions: All submissions received must include the agency name 
and Docket No(s). and Regulatory Information Number (RIN) (if a RIN 
number has been assigned) for this rulemaking. All comments received 
may be posted without change to http://www.regulations.gov, including 
any personal information provided. For additional information on 
submitting comments, see the ``How to Submit Comments'' heading of the 
SUPPLEMENTARY INFORMATION section of this document.
    Docket: For access to the docket to read background documents or 
comments received, go to http://www.regulations.gov and insert the 
docket number, found in brackets in the heading of this document, into 
the ``Search'' box and follow the prompts

[[Page 22878]]

and/or go to the Division of Dockets Management, 5630 Fishers Lane, rm. 
1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:  Michael E. Adjodha, Center for 
Devices and Radiological Health (HFZ-480), Food and Drug 
Administration, 9200 Corporate Blvd., Rockville, MD 20850, 240-276-


I. Background

    In the Federal Register of February 20, 2002 (67 FR 7620), FDA 
published a proposed rule entitled ``Dental Devices: Classification of 
Encapsulated Amalgam Alloy and Dental Mercury and Reclassification of 
Dental Mercury; Issuance of Special Controls for Amalgam Alloy.'' In 
that document, FDA proposed the following actions: (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 proposed that all three products 
would have the same labeling guidance as a special control. In 
addition, FDA proposed that dental mercury would have a voluntary 
American National Standards Institute (ANSI) standard as a special 
control; encapsulated amalgam alloy and dental mercury would have 
voluntary ANSI and International Standards Organization (ISO) standards 
as special controls; and the amalgam alloy products would have a 
voluntary ISO standard as a special control. Since that time, a 2006 
joint meeting of the Dental Products Panel and the Peripheral and 
Central Nervous System Drugs Advisory Committee raised the need for FDA 
to further consider scientific issues that are potentially relevant to 
this classification and we seek additional comments on the proposed 
    In an effort to provide an update on the latest scientific 
information concerning dental amalgam, a working group of the U.S. 
Department of Health and Human Services, known as the Trans-agency 
Working Group on the Health Effects of Dental Amalgam, commissioned a 
new review of the scientific literature in 2004 (the 2004 review). The 
2004 review, funded by the National Institutes of Health in cooperation 
with FDA, the Centers for Disease Control and Prevention, and the 
Office of the Chief Dental Officer of the Public Health Service, was 
completed in 2004 by Life Sciences Research Office, Inc. (LSRO). LSRO 
engaged an independent panel of experts from academia with preeminent 
qualifications and experience in the appropriate scientific disciplines 
needed for the 2004 review. The 2004 review was a systematic and 
comprehensive evaluation of approximately 300 peer-reviewed studies of 
dental amalgam and mercury vapor published from 1996 through 2003, 
intended to determine whether these studies provided new evidence 
related to the health effects of dental amalgam in humans. The panel 
concluded that the studies contained insufficient evidence to support a 
correlation or causal relationship between exposure to dental amalgam 
and kidney or cognitive dysfunction; neurodegenerative disease 
(specifically Alzheimer's disease and Parkinson's disease); autoimmune 
disease (including multiple sclerosis); or adverse pregnancy outcomes 
(Refs. 1 and 2).
    Dental amalgam was the subject of an advisory committee meeting in 
2006. As announced in the Federal Register of April 3, 2006 (71 FR 
16582), on September 6 and 7, 2006, FDA held a joint meeting of the 
Dental Products Panel and the Peripheral and Central Nervous System 
Drugs Advisory Committee (the 2006 joint committee). The 2006 joint 
meeting was held to discuss and make recommendations to FDA on a draft 
FDA White Paper (2006 draft White Paper) (Ref. 3) regarding the 
potential adverse health risks associated with exposure to mercury in 
dental amalgam. The goal of the 2006 draft White Paper was to provide 
an assessment and conclusions regarding significant new information and 
health risks from mercury in dental amalgam and to build on previous 
Public Health Service literature reviews and risk assessments (1993 and 
1997) and reviews by other Federal agencies since 1997. The 2006 joint 
committee, comprised of 24 panelists, heard presentations from the 
following groups: (1) Scientists; (2) regulatory officials from Canada 
and Sweden, on the scientific basis for the regulation of dental 
amalgam in their respective countries; and (3) FDA, on how the United 
States has regulated and evaluated dental amalgam. Numerous public 
speakers also presented their views.
    The 2006 joint committee then deliberated on a series of questions 
FDA had posed on its draft review of the dental amalgam literature and 
provided recommendations to the agency related to those questions (Ref. 
4). By majority vote, the committee concluded that FDA's draft White 
Paper had significant limitations. Among its criticisms, the 2006 joint 
committee identified insufficient explanation about the following: (1) 
How the scientific references were chosen; (2) failure to identify the 
significant gaps in the scientific knowledge, particularly with respect 
to exposure limits; and (3) lack of attention to sensitive 
subpopulations. The majority of the 2006 joint committee voted that it 
could not find the conclusions of the draft White Paper to be 
    Despite the limitation on the draft White Paper, the 2006 joint 
committee generally agreed that there is no evidence that dental 
amalgams cause health problems. The 2006 joint committee also agreed 
that the most recent well-controlled clinical studies, including two 
prospective clinical studies in children (Refs. 5 and 6), showed no 
evidence of neurological harm from dental amalgams. In addition, a more 
recent article corroborated this evidence (Ref. 7). Panelists provided 
individual recommendations, including recommendations that FDA consider 
requirements related to the use of dental amalgam in pregnant women and 
small children, as well as patient information to ensure that consumers 
understand that these devices contain mercury.

II. Reopening of the Comment Period

    FDA believes it is important for members of the public to have the 
opportunity to further comment on FDA's proposal. Accordingly, FDA is 
asking for comments concerning whether these devices should be 
classified into class II (special controls). We specifically request 
comments supported by empirical data and scientific evidence concerning 
this classification and these special controls. In addition, if class 
II (special controls) is the appropriate classification for these 
devices, FDA requests comment on whether the two types of special 
controls proposed by FDA in 2002 (materials and labeling) provide 
reasonable assurance of the safety and effectiveness of these devices 
and on whether the proposed special control guidance document should be 
revised in light of the recommendations and with respect to the 
discussions by the 2006 joint committee.
     Controls on the Materials. For example, should the 
material controls proposed by FDA address conformance to recognized 
consensus standards that make recommendations for testing, compressive 
strength, and identifying the mercury vapor released by the device?
     Labeling Controls. For example, how should labeling 
controls, if any,

[[Page 22879]]

address the disclosure of composition, including mercury content, and 
precautions regarding use of the device in sensitive subpopulations 
composed of individuals who respond biologically at lower levels of 
exposure to mercury than the general population? If so, which 
subpopulations should be included (e.g., children under age 6, pregnant 
and lactating women, hypersensitive or immunocompromised individuals)? 
Should the labeling controls require more specific patient labeling 
(e.g., informing patients of identified sensitive subpopulations of the 
mercury content, the alternatives to the device and their relative 
costs, and health risks associated with the failure to obtain dental 
    For the agency's future analysis of benefits and costs of the 
regulatory options for dental amalgams, FDA also requests comments, 
including available data, on the following questions:
    (1) How many annual procedures use mercury amalgams? What are the 
    (2) What are the differences in cost between amalgams and 
alternative materials (e.g., composite, other metals, ceramics, etc.)? 
Are there differences in replacement lives?
    (3) What are reimbursement rates for dental amalgam and the 
alternative materials?
    (4) How would labeling describing the risks of amalgam for certain 
subpopulations (e.g., children under age 6, pregnant and lactating 
women, hypersensitive or immunocompromised individuals) affect the 
demand for, and use of, mercury amalgam? How would the risks included 
in the labeling be communicated to those subpopulations?
    (5) What is the current exposure to mercury for patients? For 
professionals? What would be the reduction in exposure associated with 
the alternatives described previously in this section of this document?

III. How to Submit Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments regarding this document. 
Submit a single copy of electronic comments to http://www.regulations.gov or two paper copies of any mailed comments, except 
that individuals may submit one paper 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 Division of Dockets 
Management between 9 a.m. and 4 p.m., Monday through Friday.
    Please note that on January 15, 2008, the FDA Division of Dockets 
Management Web site transitioned to the Federal Dockets Management 
System (FDMS). FDMS is a Governmental-wide, electronic docket 
management system. Electronic comments or submissions will be accepted 
by FDA only through FDMS at http://www.regulations.gov.

IV. References

    The following references have been placed on display in the 
Division of Dockets Management (see ADDRESSES) and may be seen by 
interested persons between 9 a.m. and 4 p.m., Monday through Friday.
    1. Review and Analysis of the Literature on the Potential 
Adverse Health Effects of Dental Amalgam, LSRO, July 2004.
    2. Brownawell, A.M., et al., ``The Potential Adverse Health 
Effects of Dental Amalgam,'' Toxicological Reviews, 24(1):1-10, 
    3. Draft FDA Update/Review of Potential Adverse Health Risks 
Associated With Exposure to Mercury in Dental Amalgam, National 
Center for Toxicological Research, FDA, August 2006.
    4. Transcripts from the Joint Meeting of Dental Products Panel 
and Central Nervous System Drugs Advisory Committee, September 6 and 
7, 2006.
    5. Bellinger, D.C., et al., ``Neuropsychological and Renal 
Effects of Dental Amalgam in Children: A Randomized Trial,'' Journal 
of the American Medical Association, 295:1775-1783, 2006.
    6. DeRouen, T.A., et al., ``Neurobehavioral Effects of Dental 
Amalgam in Children: A Randomized Clinical Trial,'' Journal of the 
American Medical Association, 295:1784-1792, 2006.
    7. Dunn, Julie E., ``Scalp hair and urine mercury content of 
children in the Northeast United States: The New England Children's 
Amalgam Trial,'' Environmental Research, Vol. 107, Issue 1, pages 79 
to 88, May 2008.

    Dated: April 22, 2008.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. 08-1187 Filed 4-23-08; 10:15 am]