Congressman Diane E. Watson - Representing California's 33rd Congressional District
For Immediate Release
September 6, 2006
Contact: Bert Hammond
(202) 225-7084

Lois Hill Hale
(323) 965-1422
 
 

Testimony: Joint Meeting of the Dental Products Panel & the Central Nervous System Drugs Advisory Committee – Food and Drug Administration

 
 

Washington, DC—  On September 6, 2006, Congresswoman Watson presented testimony to a joint panel of Food and Drug Administration (FDA) advisers assembled to review the safety of amalgam dental fillings. The FDA panel subsequently rejected a FDA staff white paper concluding that dental amalgams are safe (see September 7, 2006 press release). Her complete testimony follows:

I want to thank the chairmen and members of the two panels assembled today, as well as Associate Commissioner Lutter and the FDA staff, for allowing me to present testimony to the Food and Drug Administration (FDA) on the issue of dental amalgam.

My name is Congresswoman Diane E. Watson.  I represent the 33rd Congressional District of Los Angeles and Culver City, California.  Prior to my current tenure in the House of Representatives, I served for 20 years in the California State Senate.  From 1981 to 1998, I chaired the California Senate Health and Human Services Committee.

I have for many decades been an advocate for banning the use of dental amalgam in the field of dentistry. In my capacity as Chairwoman of the California State Senate’s Health and Human Services Committee, I wrote into law legislation that requires dentists in the state of California to provide their patients with a fact sheet listing the risks of mercury amalgam fillings.  The legislation, called the Watson law, passed the state legislature in 1992.  However, it took another 12 years for the Dental Board of California to finally be convinced of the wisdom of complying with the law.

I am also the author of H.R. 4011, The Mercury in Dental Fillings Disclosure and Prevention Act, which prohibits, after 2008, the introduction into interstate commerce of mercury intended for use in a dental filling.

In October 2003, Washington, D.C.’s Fire Department and Hazmat Unit responded to a mercury spill at Ballou High School.  A student had obtained 250 milliliters–approximately 8 ounces–of liquid elemental mercury from the high school’s science laboratory and sold some of it to students.  The Hazmat team did not respond in time to contain the spill.  Ballou High School closed its doors for 35 days and EPA and Hazmat teams eventually tested over 200 homes for mercury contamination.  Total cleanup costs are estimated to have been in the range of $1.5 million.

Last year, a student at Cardozo High School, also located in the District of Columbia, removed a vial of mercury from the chemistry lab and disposed of it improperly.  Subsequently, school officials closed the school for over a month in order to contain and clean up the contamination.  The clean-up costs ran into multiples of tens of thousands of dollars, which did not include the sizeable additional cost of relocating a whole student body to another site.

The two mercury contaminations of D.C. public schools dramatically illustrate that mercury is one of the most toxic substances known to man.  Even a small amount of mercury exposure and contamination can have catastrophic consequences and require massive and expensive clean-up efforts.

To date, the FDA has banned mercury in disinfectants and thermometers, warned against mercury in certain foods, and prohibited the use of mercury in all veterinary products.  The UK prohibits the use of mercury silver fillings for pregnant women, and Scandinavian countries are phasing out its use.  Canada is also limiting the use of mercury fillings.

Despite growing awareness among school administrators, medical experts, scientists, government officials around the world, and the general public of the dangers of human exposure to very small amounts of mercury, the U.S. federal government continues to allow the unregulated use of mercury silver fillings in dentistry.

The FDA, the agency in charge of regulating mercury fillings, is permitting the sale of a product that has not been proven safe and has not been classified as the law requires.  It continues to allow the sale and use of mercury fillings without disclosing to the American people that mercury vapor is released during the entire life of the dental filling and that amalgam fillings contain 50% mercury, one of the most dangerous neuro-toxins known to man.

Concerns about the FDA’s failure to address properly a mercury-based product implanted just inches from a person’s–and in many cases a child’s brain–have been raised by Senator Enzi and Senator Kennedy in letters to Acting Commissioner Von Eschenbach; by Senator Hatch in a letter to former Commissioner Crawford; and by Senator Lautenberg in a letter to NIH Director Zerhouni.  Congressman Burton, the former Chairman of the Government Reform Committee, and I teamed up to hold three hearings addressing mercury amalgam. Congressional concern clearly reaches across party lines.

But congressional legislation is not the only action that needs to be taken.  It’s time for the FDA to do its job – to treat mercury amalgam as it has treated many other mercury-containing products.  It has already banned the use of mercury in disinfectants, veterinary medicines, and warns pregnant women and parents of young children to stay away from fish with mercury.  It’s now time for the FDA to take the next logical step with respect to mercury amalgams.

The FDA’s silence on mercury amalgam stands in contrast to other federal agencies.  The Centers for Disease Control, in 2005, called amalgam a source of "major exposure" to mercury, and the U.S. Public Health Service warned, in 1999, that mercury amalgam is one of the two largest sources of mercury exposure.

It should therefore come as no surprise that dental offices are one of the prime sources of mercury pollution in our environment.  In my discussions with doctors of dentistry, it is estimated that roughly 5 dental offices in higher traffic urban areas use the equivalent of 250 milliliters of mercury each year–the same amount illicitly taken from Ballou High School-- in the processing of dental amalgam material.  In each urban community there are hundreds of dentists who use mercury fillings.

It is also my understanding that, due to the toxicity of mercury, dentists are instructed not to touch the amalgam before putting it into the patient’s mouth, to change their clothes before leaving the office, and not to place carpet on their office floors.  Clearly, the amount of mercury used in dental offices around the nation dwarfs the mercury spill at Ballou High School.  The potential for accidental spills and contamination in dental offices is immense.

The term "silver filling" used by the dental profession is misleading and inaccurate since dental amalgam contains 50% mercury.  A 2006 Zogby poll found that only 24% of Americans could identify the major component of amalgam.  When informed that mercury is used in dental amalgam, over 90% of the respondents said that consumers should be entitled to know that non-toxic alternatives are available.  A subgroup of those polled were asked if they believe amalgam should be legal or illegal, and by a ratio of 7 to 1 they said it should be banned.

With fewer than one in four Americans knowing that amalgam contains significant amounts of mercury, and with over three in four Americans seeing a dentist, it’s clear that the dental profession is failing to disclose a fact that would be of extreme importance to most consumers if they were only made aware of it. When the private sector fails to disclose a salient fact, then it is the duty of the FDA to act, to inform the American public.

Two ironic tragedies exist with the ongoing use of mercury fillings.  First, mercury amalgams are completely unnecessary.  Most dentists will tell you that any cavity in a child or adult can be filled with non-mercury alternatives.  Second, the demographics of those who receive mercury fillings are changing. Today, a growing number of middle class adults do not receive mercury fillings.  Increasingly, mercury fillings are used on children (because it is easier and quicker to use than non-mercury alternatives) and lower income groups.  That children and low-income pregnant women are more often exposed to mercury amalgams than other groups should be a cause for alarm at the FDA.

I must also note that the issue of dental amalgam is of growing importance to African-American health consumers.  Both the NAACP and the National Black Caucus of State Legislators have endorsed legislation to protect children and pregnant women from mercury fillings.

The privileged sanctuary for mercury amalgam must end.  The fact of the matter is that it is dying of natural causes–if I can use an imperfect metaphor–because many dentists are beginning to use alternatives to amalgam.  But we cannot afford the luxury of allowing dental amalgam to succumb to a slow death; its toxicity to humans and the environment requires us to act immediately.  The FDA must therefore move ahead in the five following areas:

1. Public Awareness: The FDA must immediately take the simple step of insisting that the public be told, in advance of placement, that amalgam is 50% mercury, that it constitutes an exposure to a neuro-toxin, and that alternative fillings are available.

I have always believed that the most important factor in improved public health is greater public awareness and education.  That is the simple but I believe very important message of California’s Watson law.

2. Environmental Impact: The FDA has a legal duty to conduct an environmental impact study of dental amalgam, which it has not yet done, before classifying the material.

3. Proof of Safety: Makers of amalgam, like any device containing a dangerous substance, should have the burden of proving its safety.  In the case of encapsulated dental amalgam, however, amalgam manufacturers have neither sought nor been provided pre-market approval for their product.  There is no excuse for a product that contains one of the most potent neuro-toxins known to man to be distributed to the public without prior approval from the FDA.

4. Children and Pregnant Women: Ten years ago, Canada directed its dentists to cease placing mercury fillings in the teeth of children, pregnant women, and persons with kidney disease, mercury hypersensitivity, or braces.  It is well past the time for the FDA to take this sensible and important step to ensure the health and welfare of our nation.

In closing, I commend the FDA for holding this important hearing. But hearings alone are not the answer. It is now time for the FDA to address thoroughly and completely the environmental impact of mercury fillings, require proof of safety, and level with the American people about the fact that silver fillings contain a significant amount of mercury.

Thank you.

 

 

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