The first section outlines the progress by USPHS in carrying out the interagency risk management plan presented in the 1993 report.

In fiscal year 1996, the NIH National Institute of Dental Research spent $33 million on research related to dental amalgam safety and non-amalgam alternatives. Seven ($7) million of this amount has been spent on alternative materials development and $2 million in support of three Specialized Centers for Research on Materials Science, one of which is making substantial headway toward the development of a non-mercury based material whose clinical and commercial viability as a substitute for dental amalgam is currently uncertain. To date, NIDR has expended $1.7 million in support of an intramural study of approximately 1200 Air Force veterans (Ranch Hand Study) for potential adverse effects from amalgam. The NIDR has also committed $1.4 million in FY97 for two prospective trials of amalgam effects in children.

The Centers for Disease Control and Prevention, through a contract, conducted focus group testing involving consumers, dental practitioners, and non-dental health professionals to ascertain the level of awareness of potential dental amalgam risks and need for a national educational campaign. Although overall awareness was found to be low, most consumers indicated little to no concern about possible dental amalgam hazards and said they rely on dental care providers for advice on restorative care. Health professionals did not support a national education program and urged deferral of any program until definitive research on dental amalgam risks is completed. Thus, CDC professionals are selectively using presentations and articles to keep the dental care community abreast of the latest information on the risks and benefits of dental amalgam and non-amalgam alternatives.

The Food and Drug Administration is promulgating regulatory guidance to induce manufacturers of dental amalgam and other dental restorative materials and products to disclose ingredients by descending order of content by weight percentage to facilitate the diagnosis of patient allergic reactions by dental professionals and avoid the use of known allergic-causing materials. In addition, FDA is proposing new rules for the uniform regulation of dental mercury, amalgam alloys, and pre-encapsulated dental amalgam. FDA is also promoting its MedWatch and Medical Device Reporting programs to increase the frequency of adverse incident reporting by consumers, health professionals and the industry.

The second section reports on the trends in dental restorative care and utilization of commonly available materials.

The 1993 USPHS report on dental amalgam stated that in 1990, over 200 million restorative procedures were provided in the U.S.; of these, dental amalgam accounted for roughly 96 million, a 38 percent reduction since 1979.

A quarterly survey of 1,250 dentists covering the period 1990-1995, performed by the American Dental Association, shows that the mean number of posterior restorations performed during a typical week (usually with dental amalgam) was 19.51 in the fourth quarter of 1990, compared to 17.08 in the fourth quarter of 1995 (all dentists). For general practitioners, the mean numbers were 23.11 and 19.76, respectively.

The results of a 15-year (1980-1995) study conducted by University of Michigan researchers, which traced changes in dental health and treatments among 750,000 Michigan residents with dental insurance, showed substantial improvements in oral health and a corresponding reduction in restorative care.

Anecdotal information from pediatric dentists indicates a move away from dental amalgam.

In the third section, the report summarizes the state of science with respect to dental amalgam and alternative materials, in addition to describing the efforts of the USPHS to stay up-to-date on relevant research developments.

In 1994 and 1996, USPHS agencies sponsored workshops featuring invited researchers from the national and international scientific communities. The 1994 workshop focused on methods for assessing mercury exposure; developmental effects of mercury exposure on the central nervous system and target organs; methods for evaluating health effects; modulating effects of mercury exposure; and need and directions for clinical research. In 1996, attention was paid to appropriate biomarkers of exposure to mercury vapor; development of physiologically-based pharmacokinetic models for mercury vapor exposure to predict tissue levels and resultant toxicity; and appropriate neurobehavioral endpoints to identify neurotoxic effects of mercury.

In 1997, with input from a broad cross-section of scientists and dental professionals within USPHS, the FDA completed a review of nearly 60 studies that were published in peer reviewed scientific literature and were cited by citizen groups that petitioned the agency for stringent regulatory actions against dental amalgam. The analysis of the cited studies indicated that the current body of data does not support claims that individuals with dental amalgam restorations will experience adverse effects, including neurologic, renal or developmental effects, except for rare allergic or hypersensitivity reactions.

The fourth section of the report represents a global view of the dental amalgam issue. It examines legal actions taken against dental amalgam in the U.S. and the outputs of several risk assessments performed by individual nations and international bodies. It also documents the considerable outreach in which USPHS officials have been engaged in order to complement and add credibility to the work of USPHS agencies.

In the State of California, an environmental advocacy group has taken legal action under the State's Proposition 65 (Safe Drinking Water and Toxic Enforcement Act) to require dental offices in which dental amalgam is used to post warnings on reproductive toxicity. Although one amalgam manufacturer settled with the plaintiff, other manufacturers formed a consortium to contest the suit. Following judicial appeals by both sides, the parties are negotiating a final settlement.

The Food and Drug Administration has responded to three separate citizen petitions that called for varying degrees of regulatory action relating to dental amalgam, including a product ban and restrictions on its use. The petitions followed an unsuccessful attempt by petitioners to sue the FDA and have a court direct the agency to impose regulatory sanctions. FDA has responded to these petitions stating that the agency does not believe there is scientific justification for discontinuing or curtailing amalgam use.

In 1994, the USPHS convened an international summit of government health officials in Berlin, Germany to share and elicit information on the state of science relating to amalgam safety. General consensus was reached that no current scientific evidence demonstrates a health hazard to the general population from dental amalgam use, although a small percentage of treated patients do experience mild, normally transient allergic reactions. A follow-up conference, planned by a USPHS-led steering committee, is tentatively scheduled for later in 1997 or early 1998.

The governments of Sweden and Denmark have recommended against the use of mercury-containing materials as part of national environmental protection initiatives provided that suitable non-amalgam materials are available. The German government has recommended against the placement of dental amalgam and dental restorative materials in general in patients with demonstrated allergy to such materials, as well as patients with severe renal dysfunction. Germany has also advised against the placement of dental amalgam and the removal of amalgam fillings in pregnant women as a precautionary measure while at the same time acknowledging the lack of evidence that exposure of the unborn to mercury released from the mother's amalgam fillings causes any health damage to the child.

The European Commission, the governments of Canada, Quebec and New Zealand, and the World Health Organization have independently evaluated the current body of science relating to dental amalgam safety and universally concluded that the vast majority of people treated with dental amalgam are not at risk. Notwithstanding this conclusion, Canada and its province of Quebec have recommended prudence in dental intervention therapies for certain patient sub-populations such as pregnant women.