FDAnews Device Daily Bulletin

Lawmakers Crack Down on FDA’s Environmental Policy

Aug. 5, 2008
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A House subcommittee is accusing the FDA of not following National Environmental Policy Act (NEPA) requirements and calls on the agency to reform its rulemaking concerning dental mercury.

In a July 28 letter to FDA Commissioner Andrew von Eschenbach, the Domestic Policy Subcommittee addresses the agency’s “total disregard” of NEPA requirements to prepare an environmental impact statement (EIS) or environmental assessment (EA) when creating new federal rules, specifically those regulating dental devices containing mercury.

The letter, signed by Rep. Dennis Kucinich (D-Ohio) as committee chairman, reminds the FDA of its duty under NEPA to prepare an EIS or an EA as part of the rulemaking process in reclassifying dental mercury, classifying encapsulated amalgam alloy and dental mercury or issuing special controls for amalgam alloy.

According to the letter, NEPA’s purpose is “to require federal agencies to take a ‘hard look’ at the environmental consequences of their actions” when making decisions.

The FDA said it inadvertently erred in the 1980s when it did not separately classify encapsulated amalgam alloy and dental mercury as Class II devices. When it reopened the case in 2002, the agency maintained that its proposed regulation of mercury-related dental devices was excluded from NEPA and did not require an EA because the devices were “of a type that does not individually or cumulatively have a significant impact on the human environment,” according to the letter.

As part of a recent settlement in a lawsuit filed by Moms Against Mercury, the FDA agreed to classify dental amalgam by July 28, 2009. After reviewing any comments submitted during the required comment period, the FDA will issue a final rule classifying the product and possibly requiring revised labeling.

The FDA did not return calls for comment. The letter is available at www.fdanews.com/ext/files/NEPA.pdf.