Mercury Policy Project recently wrote a letter supporting the U.S. Government (USG) leadership calling for mercury amalgam “…phase down, with the goal of eventual phase out” in its most recent submission to the UN Mercury International Negotiating Committee (INC). The letter also urges the USG to not succumb to the ADA’s recommendations to have FDA assume a leading role in the INC process, given that EPA, and not FDA has the expertise to address the global threat of mercury amalgam releases.
In its April 7 letter, the ADA requested that control over mercury amalgam policy for the treaty be shifted from EPA to FDA. Yet FDA is charged with regulatory measures related only to health; this treaty is more about mercury’s environmental impact and the resulting impacts on human health, primarily through fish consumption. FDA admits in its rulemaking that it lacks environmental expertise. The FDA does not appreciate, nor have the expertise, to address the global threat of mercury amalgam releases.
1. FDA has no jurisdiction over environmental matters: FDA states that environmental problems caused by amalgam are not within its jurisdiction; they are EPA’s jurisdiction: “FDA does not regulate the disposal of dental amalgam. The disposal of dental amalgam is regulated by the Environmental Protection Agencyand state and local authorities.” When the Joint Advisory Panel of 2006 asked FDA to evaluate the environmental impact of amalgam, FDA responded that the recommendation was beyond its scope.
2. FDA lacks environmental science expertise: FDA does not have a good understanding of the environmental health risks related to mercury amalgam releases, as demonstrated by its statement:
“Is the mercury in dental amalgam the same as the mercury in some types of fish? No… The form of mercury associated with dental amalgam is elemental mercury. The form of mercury found in fish is methylmercury, a type of organic mercury. Mercury vapor is mainly absorbed by the lungs. Methylmercury is mainly absorbed through the digestive tract. The body processes these forms of mercury differently and has different levels of tolerance for mercury vapor and methylmercury. Methylmercury is more toxic than mercury vapor.”
Yet this statement is inconsistent with EPA’s conclusion that once amalgam is in the environment, “certain microorganisms can change elemental mercury into methylmercury, a highly toxic form that builds up in fish, shellfish and animals that eat fish… Methylmercury can damage children’s developing brains and nervous systems even before they are born.”
3. FDA’s stance is inconsistent with the current U.S. position: Contrary to the most recent U.S. submission to the Mercury Intergovernmental Negotiating Committee, FDA openly advocated in its dental amalgam rule for an increase in the use of mercury without any consideration of the public health threat of dental mercury pollution: “any change toward use of dental amalgam is likely to result in positive public health outcomes.” Despite urging an increase in amalgam usage, FDA nonetheless refused to even prepare an environmental impact statement, demonstrating that the agency does not appreciate the environmental health impact of mercury products.
As you know, EPA has recently decided to regulate mercury amalgam releases into the environment through a proposed effluent guideline. It has the jurisdiction to regulate dental offices release of mercury amalgam in order to significantly reduce the largest source of mercury going into municipal waste water plants today. Clearly, EPA, not FDA, has the expertise to guide the USG on global mercury releases.