[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]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
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.
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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
methods:
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-
3688.
SUPPLEMENTARY INFORMATION:
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
classification.
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
``reasonable.''
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
care)?
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
trends?
(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,
2006.
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]
BILLING CODE 4160-01-S