The FDA, ADA, and the federal government spiced things up on Capitol Hill this summer as they jousted over the safety, classification, and regulation of dental amalgam.
It has been a busy summer on the dental amalgam front. The Food and Drug Administration (FDA) issued a ruling in July categorizing encapsulated dental amalgam as a class II medical device, placing it in the same class as gold and tooth-colored composites. This decision not to place any restriction on the use of dental amalgam, a commonly used cavity-filling material met with approval from the American Dental Association (ADA), which has supported a class II designation for dental amalgam since 2002 when first proposed by the FDA.
“This decision underscores what the ADA has long supported—a discussion between dentists and patients about the full range of treatment options to help patients make educated decisions regarding their dental care,” ADA President Dr. John Findley stated in a release by the organization.
Scientific studies indicate dental amalgam is a safe, effective cavity-filling material for children and others. In its 2009 review of the scientific literature on amalgam safety, the ADA’s Council on Scientific Affairs reaffirmed that the scientific evidence continues to support amalgam as a valuable, viable, and safe choice for dental patients.
The issue of mercury—and by extension, dental amalgam, which contains mercury—is not without dispute on the federal level, however. Following President Obama’s lead, the United States joined more than 140 nations supporting an international treaty on the use and supply of mercury as part of a global initiative to regulate mercury by the United Nations Environmental Programme (UNEP), according to a UNEP release. While the regulations are mainly targeted at industrial applications, the dental industry has not escaped notice, with the issue of dental amalgam separators a key point of contention. A congressional hearing on environmental concerns related to mercury in wastewater brought the issue front-and-center on Capitol Hill.
Government officials and activist groups have been pushing for legislation requiring all US dental practitioners to have an amalgam separator installed in their offices; they are currently mandated by law in nine states. The ADA opposes this legislation on the grounds of “unnecessary financial burden” to the dentists (and subsequently, patients), according to a report by the Associated Press (AP). William J. Walsh, counsel for the ADA on amalgam wastewater issues, testified that the ADA has issued “best management practices” for handling waste amalgam, which include control methods, recycling, and amalgam separators. The ADA has also engaged in and supports “voluntary cooperative partnerships” to reduce the environmental impact of dental mercury emissions.
These efforts have been made despite the fact that ADA maintains that “less than 1% of the total mercury found in our lakes and streams” comes from dental offices, Walsh said. While statistically 40% to 50% of mercury in wastewater comes from dental offices, 99% of this is subsequently captured in wastewater treatment facilities before it can reach surface water. The impact on this number from amalgam separators is minimal, with the only significant difference being that the mercury is captured before entering the sewage system.
Walsh added that dentists have worked hard to keep filling pieces from getting into wastewater and today manage to keep about 80% from leaving their offices. “Dentists drink and fish and swim in the same waters as everyone else in their communities,” Walsh said. “They bring to these efforts the same commitment they bring to providing the best possible oral healthcare to the American people.”
According to the AP report, Rep. Dan Burton (R-IN) and Rep. Diane Watson (D-CA), who heard Walsh’s testimony, were skeptical and intimated that the ADA and state dental organizations were blocking attempts to regulate the use of amalgam separators, and Rep. Dennis Kucinich (D-OH) dressed down the FDA in a letter to Commissioner Andrew von Eschenbach, MD, the FDAnews Device Daily Bulletin reported in August. Kucinich wrote of the FDA’s “total disregard” for National Environmental Policy A (NEPA) requirements in its reclassification of dental mercury. According to the letter, NEPA requires “federal agencies to take a ‘hard look’ at the environmental consequences” of their decisions.
The Evolving Role of the Dental Hygienist
Minnesota legalizes a “midlevel dental provider” position, and a movement marches on.
After much debate, in May Minnesota became the first state to pass legislation creating a “midlevel dental provider” position in an effort to alleviate a serious problem in Minnesota of untreated dental disease among low-income, disabled, elderly, and rural populations caused by a shortage of dentists available to serve them. A large coalition of healthcare and consumer organizations supported the proposal, according to a news release by Sen. Ann Lynch (D-Rochester), who sponsored the legislation.
Under the Minnesota law, dental therapists will be required to graduate from a training program, pass a competency examination, and be licensed by the Board of Dentistry. Dental therapists will, for the most part, practice in a dental clinic under the overall supervision of a dentist and with a dentist on-site whenever fillings or extractions are performed. However, to improve availability of dental treatment where no dentists are available, the law also allows dental therapists who meet the aforementioned requirements to treat patients without a dentist on site. The advanced dental therapist would still work under the overall supervision of a dentist.
Minnesota’s dental therapists will be allowed to treat patients who have access-to-care issues, such as low-income people on Medicaid, the elderly in nursing homes, people with physical or developmental disabilities, children in Head Start programs, and rural communities with a dentist shortage.
Two Minnesota educational institutions are planning to establish training programs for dental therapists. The University of Minnesota will offer an undergraduate program for high school graduates to become a dental therapist. The Minnesota State Colleges and Universities system will offer a Master’s program for experienced dental hygienists who want to become advanced dental therapists. The first dental therapy students are expected to graduate in the spring of 2011.
In related stories, Massachusetts passed a bill in July to allow dental hygienists to work unsupervised in limited public settings. Similar to the legislation in Minnesota, the bill will enable hygienists to practice in community health centers, schools, nursing and other long-term care facilities, and in residences of homebound persons, according to a report in the Worchester Telegram & Gazette. The bill passed the Massachusetts Senate and as of this writing was before the House.
ADEA Charting Progress
Opportunities abound for new dental schools. How will we seize them?
Dr. Richard Valachovic, Executive Director of the American Dental Education Association, considers the role new dental schools can play in promoting best educational practices.
Since I wrote to you about this topic a little over a year ago, most of our institutions have experienced some significant belt tightening in response to the economic downturn. Yet despite the difficulties facing higher education for the foreseeable future, the desire to create new dental schools remains strong. Five are in the planning stage, and two are well under way. One of these, Western University of Health Sciences College of Dental Medicine in Pomona, California, welcomed its first class earlier this month, and the other, East Carolina University School of Dentistry, began recruiting faculty and staff this summer.
There is a trend here without question, but a trend will not put controversy to rest. Stakeholders within and outside our community fear new schools may become “factories” for producing clinicians ill-prepared to keep pace with developing science and the demands of evolving delivery systems. Skeptics even challenge the notion undergirding most new school initiatives: that producing more dental graduates is the key to solving the problem of access to care.
Are these worries legitimate? Are they overblown? Can we move beyond the controversies surrounding new schools and seize upon the opportunities they provide us?
To read Dr. Valachovic’s comments in their entirety, visit www.adea.org/about_adea/Documents/ADEAs_Charting_Progress_August_2009.htm.