DENTAL AMALGAM AND ALTERNATE RESTORATIVE MATERIAL

Appendices

Policy Statement by the U.S. Public Health Service
On the Safety of Dental Amalgam
The U.S. Public Health Service believes it is inappropriate at this time to recommend any restrictions of the use of dental amalgam, for several reasons. First, current scientific evidence does not show that exposure to mercury from amalgam restorations poses a serious health risk in humans, except for an exceedingly small number of allergic reactions. Second, there is insufficient evidence to assure the public that components of alternative restorative materials have fewer potential health effects than dental amalgam, including allergic-type reactions. Third, there are significant efforts underway in the U.S. to reduce the amount of mercury in the environment. And finally, as stated previously, amalgam use is declining due to a lessening of the incidence of dental caries and the increasing use of alternative materials.
From the January 1993 USPHS Report on Dental Amalgam.

Update Statement By the U.S. Public Health Service
On the Safety of Dental Amalgam
The U.S. Public Health Service (USPHS) continues to maintain a strong interest in the promotion of effective health strategies to foster the oral health of Americans and to ensure high quality dental care services. The USPHS continues to believe that the primary oral health goal is to preserve healthy, functional, and natural tooth structure for as long as possible. Every effort should be made to prevent initial carious lesions through personal, professional, and community-based hygiene measures.

In January 1993, the USPHS released a comprehensive report on the risks and benefits of dental amalgam, which recommended that the use of amalgam in dental practice should continue given the absence of scientific proof of a human health hazard for patients with amalgam restorations. In addition, the report outlined a risk management program designed to enhance risk quantification, risk communication, and regulatory oversight of amalgam. The multi-agency program is being coordinated by an interagency sub-committee on Dental Amalgam,* formed in 1994 by the Assistant Secretary for Health under the aegis of a PHS Environmental Health Policy Committee (EHPC).

This ongoing program consists of a broad range of basic and applied research studies directed at amalgam safety, development of alternative restorative materials, and improved dental practices relating to caries treatment and amalgam use. A risk-benefit educational program for dental professionals and patients and ingredient labeling requirements for various dental products—including amalgam—are now under development. An international scientific exchange forum on amalgam safety is also under consideration.

To ensure that the USPHS remains broadly versed on the dental amalgam issue, members of the Subcommittee met in Berlin, Germany on December 15, 1994, with senior government health officials from nine European nations and Canada. The meeting focused on the policies of individual countries regarding amalgam use, as well their scientific basis and legal standing.

Participants at the meeting generally agreed that the scientific literature has not revealed evidence of adverse health effects from exposure to dental amalgam for the vast majority of people. Nevertheless, policy differences do exist.

Countries implementing or contemplating restrictions on amalgam use are doing so based on environmental concerns or as a preventive action against theoretically possible adverse health effects. Efforts are underway to continue the dialogue begun in Berlin.

Based upon information obtained from international policy-makers and scientists, in addition to the continued absence of evidence of a human health hazard for patients associated with dental amalgam, the EHPC on January 30, 1995, unanimously agreed to reaffirm the January 1993 PHS policy regarding amalgam restorations.

The USPHS recognizes that the use of dental filling materials will remain an integral part of dental treatment for the foreseeable future. Therefore, the USPHS reiterates its earlier conclusion that there exist no scientifically compelling reasons either to discontinue or to curtail the clinical use of dental amalgam or to recommend removal of existing amalgam fillings absent clear evidence of allergy or intolerance in individual patients.

Through the Subcommittee on Dental Amalgam, (the Subcommittee on Dental Amalgam was renamed in 1996 as the Working Group on Dental Amalgam.) the Public Health Service will continue to monitor closely all relevant research and amalgam policy activities to ensure the currency and appropriateness of its policy on this issue. In addition, the USPHS will continue to encourage the development and expanded use of effective caries preventive agents and techniques as well as the development of non-mercury containing dental filling materials as alternatives to amalgam.

*The Subcommittee on Dental Amalgam was renamed in 1996 as the Working Group on Dental Amalgam.

Approved: September 1, 1995

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