Congress To Hear FDA's Failure To Classify Amalgam

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Congress To Hear FDA's Failure To Classify Amalgam
11/08/2007
IAOMT News

Congressional hearing notice published:

Environmental Risks Of And Regulatory Response To Mercury Dental Fillings
Wednesday, November 14, 2007
2 p.m.
2154 Rayburn
Washington, D.C. 20515
This hearing will examine the environmental risks of mercury in dental fillings (known as dental mercury amalgam) and the governmentÌs regulatory response to it.

Dental offices are the third-largest user of mercury in the United States. Mercury contained in the existing dental fillings of Americans comprises over half of all mercury in use today, amounting to more than 1,000 tons. According to the U.S. Environmental Protection Agency (EPA), ÏMercury discharges (in wastewater) from dental offices far exceeded all other commercial and residential sources.Ó These discharges may have a significant negative effect on the environment. Sludge, the mercury-contaminated byproduct of municipal sewage treatment plants, is often incinerated, causing the formation of Ïmethylmercury,Ó the most toxic and dangerous form of mercury.

EPAÌs only dental mercury-specific program is an educational program to encourage new dentists to use equipment to prevent mercury from entering the wastewater.

Mercury dental devices are regulated by the Food and Drug Administration (FDA), but FDA has never conducted an environmental assessment of the use of dental mercury amalgam as prescribed by law.

Witnesses for the November 14 hearing include:
Panel I
Ô TBD, Environmental Protection Agency
Ô Dr. Norris Alderson, Director, Office of Science and Health Coordination, Food and Drug Administration
Panel II
Ô Mr. Ray Clark, Senior Partner, The Clark Group, LLC
Ô Mr. Bruce Terris, Partner, Terris, Pravlik & Millian, LLP
Ô Mr. C. Mark Smith, Co-Chair, Mercury Task Force, New England GovernorÌs Conference
Ô Mr. Michael Bender, Executive Director, Mercury Policy Project
Ô Mr. Rod Mackert, Dentist and Faculty Member, Medical College of Georgia
Congress Demands Account from FDA for Refusing

To Classify Mercury Fillings & Refusing To Do E.I.S.

Members of Congress increasingly disgusted with FDAÌs refusal to classify mercury fillings and refusing to do an Environmental Impact Statement about this issue are calling the agency to task. At the request of Congresswoman Diane Watson and Congressman Dan Burton, the Subcommittee on Domestic Policy of the House Committee on Government Reform will have a hearing in the Rayburn Bldg. on Wed., Nov. 14, 2007, at 2:00 pm. The Chairman of the Subcommittee is maverick Congressman Dennis Kucinich of Ohio, a friend of alternative medicine. We express our deep appreciation to Congressman Kucinich for calling FDA to account.

--Charlie Brown, National Counsel, Consumers for Dental Choice

Background: Since 1976, the FDA has placed all medical devices into three classifications based on the relative risk each poses to human safety, but they have always managed to avoid classifying pre-capsulated and mixed dental amalgam. Class I devices pose the least risk, and require the least oversight. Examples are band-aids, exam gloves, and dental mercury! Class II devices present moderate risk and get more regulatory oversight. Examples are powered wheelchairs, infusion pumps, and dental alloy. Class III devices pose serious risks, and require proof of safety and efficacy. Examples of these include breast implants and replacement heart valves.

The fact that there is no classification for pre-capsulated and mixed dental amalgam means that the amalgam-using dentist is the manufacturer of record of an unregulated product. The liability issues have never been tested. In recent years, the pro-amalgam FDA staff has made some moves to quietly place all amalgam in Class II, which would remove it from serious examination of safety issues, but they have been opposed by IAOMT and Consumers for Dental Choice. Our respective lobbying efforts have led to the hearing scheduled for November 14, to once again bring the FDA's failure to deal honestly with amalgam into the light.