U.S. FDA Warns Women and Children about Mercury Dental Fillings, Settles Lawsuit

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After 32 years of delay, the Food and Drug Administration has finally agreed to comply with the law and set a date to classify mercury amalgam as a substance that poses a health risk to pregnant women and unborn babies, and children. This about-face resulted from settling, earlier this week, our lawsuit, Moms Against Mercury et al. v. Von Eschenbach, Commissioner, et al. (see Press Release) Stating it was an “unreasonable delay” and “an reasonable case of failure to act.” As reflected in the May 16, 2008 court transcripts, Judge Ellen Huvelle states that the “probability of harm is enormous,” and asked the FDA: “How could you drag your feet for 32 years? Do what you are supposed to do.” (see full transcript) Judge Huvelle also states that she couldn’t “order a ban, but can compel to act,” observing that this was “government at its worst” and that she wanted this “public safety issue to be resolved.” The FDA must now finish classification within one year of the close of the public comment period on its amalgam policy, that is, by July 28, 2009.

As part of the settlement, the FDA agreed to and, with uncharacteristic speed, has already changed its website— dramatically. The Updated June 3, 2008 FDA website now states, for example:
“Dental amalgams contain mercury, which may have neurotoxic effects on the nervous systems of developing children and fetus.” “Pregnant women and persons who may have a health condition that makes them more sensitive to mercury exposure, including individuals with existing high levels of mercury bioburden, should not avoid seeking dental care, but should discuss options with their health practitioner.”

The FDA website also now states that “Some other countries follow a “precautionary principle” and avoid the use of dental amalgam in pregnant women” and provides links to advice about amalgams from regulatory agencies in other countries, including Canada , France and Sweden. These warnings are similar to those sent from the manufacturers. Encapsulated dental amalgam arrives at a dentist’s office with skull and cross bones affixed next to the words “POISON, CONTAINS METALLIC MERCURY.” Amalgam manufacturers – Kerr, Vivadent and Dentsply – advise dentists against placing amalgam in pregnant women, nursing mothers, children under six, and anyone with kidney disease. Dentsply warns: “Contraindication (N.B.: “Contraindication” is a directive to forbid, not just a “warning.”) “In children 6 and under” and “In expectant mothers.” However, these warnings appear not to have been passed to the public, based on the results of a national poll conducted for MPP by Zogby International whereby most Americans (76 percent) don’t know mercury is the primary component of amalgam fillings; 92 percent of Americans overwhelmingly want to be informed of their options with respect to mercury and non-mercury dental filling materials prior to treatment; and 77 percent of Americans would choose higher cost fillings that do not contain mercury if given the choice.

Brown Researchers Create Mercury-Absorbent Container Linings for Broken CFLs

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Brown University researchers have discovered a nanomaterial that can absorb the mercury emitted from a broken compact fluorescent lamp (CFL). The researchers, led by Robert Hurt, professor of engineering, and engineering student Natalie Johnson, have created a mercury-absorbent container lining that can be used commercially. The packaging invention, for which Brown has applied for federal patents, would relieve a major concern with CFL use and comes as CFL sales are projected to skyrocket. For more information, see the link to the Brown University press release.

EU Adopts Mercury Export Ban

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The European Parliament recently adopted a ban on the export of mercury from the EU, one of the world’s biggest mercury exporters, and ensuring its safe storage, beginning in March 2011. In addition to metallic mercury, the ban covers other compounds such cinnabar ore, mercury chloride and oxide. The regulation requires the storage of mercury either in salt mines, in deep, underground, hard rock formations, or in above-ground facilities. “Although we would have liked to see a more robust regulation, this agreement between the two institutions is a very good step towards locking down mercury in the EU,” said Elena Lymberidi Settimo, EEB’s Project Coordinator of the Zero Mercury Campaign (see press release).

The EU Commission is required to submit by 2010 a report on any technological advances in the solidification of mercury and, if appropriate, a proposal for revision of the directive not later than 15. March 2013. In addition, the Commission must report by 2010 if there is a need for an import ban on mercury and if the export ban should be extended to other compounds, mixtures and products containing mercury, in particular thermometers, barometers and sphygmomanometers. More information on the EU mercury export ban.

Groups Launch Green Lighting Campaign

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Environmental groups from New York to California are taking a pledge to consider only the “greenest” CFLs when making purchases for office use and during compact fluorescent lamp giveaways. The new “Green Lighting Campaign” intends to promote more sustainable lighting practices such as recycling, rather than throwing lamps containing mercury in the trash. Toxic levels in lamps have created concerns when the lamps are produced, transported, installed, broken or disposed of, say advocates. Absent mercury content reductions and manufacturing dosing improvements, global mercury use will increase with expanding fluorescent lighting use, and negate dramatic mercury reductions anticipated in most other sectors. Offered by a coalition of groups (see press release), the guidance and pledge have other organizations considering steps to include more than energy efficiency when determining their lighting purchases.

Millions of lamps are purchased every year, a decision typically made by a handful of people. Many work with or in non-profit groups, who then distribute them to the public. Lamp giveaways are held to help educate and motivate the public around issues of energy efficiency and climate change. By making these purchases influence more than the climate change issue, the Green Lighting Campaign seeks to influence the overall market for lighting products. “As we choose compact fluorescent lamps to combat global warming, we can and should reduce toxic pollution at the same time,” said Bill Magavern, Director of Sierra Club California. “The Green Lighting Campaign seeks to protect households and workers from both mercury pollution and climate change.”

New CFL Breakage Clean-Up Guidance

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Tests conducted by the State of Maine (see FAQ and Clean-Up Instructions) confirm earlier states findings suggesting that under certain conditions mercury vapor released from a broken compact fluorescent lamp can pose a health risk. As a precaution, states like Vermont and Massachusetts are now suggesting removal of carpeting where breakage has occurred where there are infants and pregnant women present. A report MPP released today recommends that sensitive populations should take extra precautions to reduce risks associated with breakage, but says that CFLs generally can and should still be used in everyone’s homes until a nontoxic light bulb becomes available. The report also recommends the adoption of more comprehensive environmental and human health guidelines by decision makers that, in addition to energy-efficiency, address other concerns, including:

  • Reduced toxicity while maintaining performance;
  • Improved breakage resistance and longer lamp life (which can reduce manufacturing, transportation and disposal impacts);
  • Sustainable manufacturing processes (such as the use of encapsulated mercury-dosing technologies);
  • Responsible end-of-life management (particularly through producer responsibility in funding lamp collection and retailer collection programs)
  • Innovative technologies such as light-emitting diodes (LEDs) that use less- or non-toxic materials, that have significantly longer life, are much more efficient for certain applications, and/or that offer other measurable environmental benefits.

In response to the Maine CFL breakage study, the US EPA has made some changes to its CFL clean up guidance.

However, according to MPP Director Bender, the EPA advice could be readily improved through following new state guidance which 1) recommends against vacuuming and 2) instead favors cleaning up the debris with cardboard and sticky tape and quickly removing it from the home, so as to 3) minimize vaporization of mercury.

Investigation of EPA’s Dental Mercury Emissions Estimate

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As a result of its findings from a November 14, 2007 hearing at which MPP Director Bender testified, the US House Domestic Policy Subcommittee of the Committee on Oversight and Government Reform is conducting an investigation into the work of the Environmental Protection Agency (EPA) to determine if EPA has underestimated mercury emissions related to dental use of mercury. The Subcommittee’s hearing revealed significant disparities between the agency’s data for mercury emissions related to dental use of mercury and other estimates. EPA has even expressed a lack of confidence in some of its estimates. Furthermore, there are a number of other emissions pathways for which EPA has failed to develop any estimates, as the attached letter from the Subcommittee to EPA Administrator Steve Johnson outlines. It its letter, Chairman Dennis Kucinich requests that EPA provide specific information to the Committee no later than Feb.29, 2008.

Oceana/MPP Study Shows High Tuna Levels

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Mercury has again been in the news with the release of new data on mercury levels in tuna sushi by the New York Times and Oceana/Mercury Policy Project study. While the results were startling–around 1 of 3 pieces of tuna tested had levels above FDA’s action level of 1 PPM–the attack by special interests against those covering the news was swift and erroneous. Seemingly, according to these special interests, everyone including pregnant women and children could eat as much high mercury fish as they wanted, without any risk. In response, 29 mercury experts from 11 countries signed on to the following open letter to set the record straight.

US House Committee to Evaluate Dental Mercury

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The U.S. House Oversight and Government Reform Committee will hold a hearing on Wednesday, Nov. 14, to discuss FDA’s responsibility to evaluate the harmful environmental impacts of mercury dental fillings and to question why FDA has not finalized a rule proposed in 2002 to classify mercury tooth fillings under the Medical Device regulations. “The Hearing will show that dental uses contribute to high mercury levels in fish Americans consume,” said MPP Director Michael Bender. “Testimony will also show, for the first time, that dental mercury air emissions may be more than five times higher than recent EPA estimates.” Bender’s testimony comprehensively lays out the extent of the problem, and the need to reduce this pollution source.