FDA is Required by NEPA to Prepare an Environmental Impact Statement

The National Environmental Policy Act of 1969 contains a declaration policy whichrequires the federal government to use all practicable means to create and maintain conditionsunder which man and nature can exist in productive harmony. Section 102 requires federalagencies to incorporate environmental considerations in their planning and decision-makingthrough a systematic interdisciplinary approach.

The FDA received a letter dated July 28, 2008, from Dennis J. Kucinich, ChairmanDomestic Policy Subcommittee of the Oversight and Government Reform Committee, regardingthe requirements imposed by the National Environmental Policy Act of 1969 (NEPA) (42 U.S.C.4371 et seq.) requiring FDA to prepare an Environmental Impact Statement (EIS), or, at aminimum, an Environmental Assessment (EA), before the FDA promulgated any final actionrelating to the reclassification of mercury/silver fillings. This letter stated in part:

In the face of these clear legal requirements of NEPA-and the emerging consensusof the harms to the environment from dental mercury-the FDA has maintained in conversation with Majority Staff that the FDA is not required to undertake an EIS or EA because its specific regulatory action here-reclassification and classifìcationof dental mercury devices-merely perpetuates the status quo amount of use of these devices and therefore does not in itself have significant effects. The FDA’s position, however, undermines NEPA’s purposes and has been expressly rejectedby the courts. In Louisiana v. Lee, the Court considered the Army Corps of Engineers’ argument that its renewal of permits allowing dredging in Louisiana’s Lake Pontchartrain would not trigger an environmental review under NEPAbecause it would merely preserve the status of quo of dredging of the Lake.39 In rejecting this argument, the Court held that “[t]he renewal of these permits will not maintain a status quo, but rather will continue a course of environmental disruption begun years ago.” The Court ruled that the damage from dredging was continuingand cumulative and thus the regulatory action of renewing permits, even if it did not lead to more dredging than before, would significantly affect the environment.

Here, the FDA attempts to rely on the same argument discredited in Lee. While theproposed classification and reclassification of mercury-related dental devicesmay arguably maintain some sort of regulatory status quo, it would certainly not maintain an environmental status quo. The continued introduction ofmercury into the environment attributable to dental devices would, by dint ofits highly toxic, persistent, and bioaccumulating nature, “continue a course ofenvironmental disruption begun years ago.” The load of mercury from dentaldevices in the air, water, and in the food chain can be expected to increase.

Recent case law has reaffirmed that before an agency eschews an EA or EISrequired by NEPA, it must take a “hard look” at the environmental consequencesof a proposed action, including a consideration of all foreseeable direct and indirectaction. After undertaking such a “hard look,” an agency must put forth a”convincing statement” of reasons that explain why the agency action will impactthe environment no more than insignifrcantly. Without such an analysis, courtshave reversed agency determination as “arbitrary and capricious” pursuant tothe Administrative Procedure Act. Here, the FDA’s position seems to have been manufactured primarily for the purpose of stymieing this Subcommittee’s inquiry.In response to the Subcommittee document request, it was notable how littleconsideration the FDA has ever given NEPA requirements when classifyingmercury-related dental mercury. The documents produced to the Subcommitteeadded little to the FDA’s cursory unexamined invocations of its own categorical exclusions found in its rulemaking. The FDA certainly provided no contemporaneous documentation demonstrating its consideration of theenvironmental consequences of its rulemaking in 1980, 1987, or 2002; no analysiswhether its proposed action met the specific criteria of this categorical exclusionin 1987; no evidence that it was relying on the “status quo” legal theory at anytime from 1980 onward; and no acknowledgement more recently that the EPA,states, and localities were scrambling to implement controls on dental mercuryin response to the growing body of scientific knowledge that demonstrated the scope and scale of specific harms caused by the introduction of dental mercury into the environment. Instead, it appears that the FDA’s position is a post hocrationalizafion of the FDA’s decision to ignore NEPA’s mandates. [Emphasisadded.]

The FDA claims that NEPA does not apply because FDA is entitled to a categorical exclusion.As Congressman Kucinich says, “FDA’s cursory unexamined invocations of its own categoricalexclusions found in its rulemaking. In reality the CFR places a different requirement on the FDA:

40 C.F.R. § 1508.4 Categorical Exclusion.

Categorical Exclusion means a category of actions which do not individually orcumulatively have a significant effect on the human environment and whichhave been found to have no such effect in procedures adopted by a Federal agencyin implementation of these regulations (§ 1507.3) and for which, therefore, neitheran environmental assessment nor an environmental impact statement is required.An agency may decide in its procedures or otherwise, to prepare environmentalassessments for the reasons stated in § 1508.9 even though it is not requiredto do so. Any procedures under this section shall provide for extraordinarycircumstances in which a normally excluded action may have a significantenvironmental effect. (Emphasis added)

A “Categorical Exclusion” does not apply to the classification of dental amalgam. In reality theFDA should have done an EIS soon after the act was passed in 1976 and certainly by the timemercury was put in Class I in 1987. The FDA’s failure to do an EIS in 2009 is indefensible.

In its Final Rule, FDA refers to comments stating that an Environmental ImpactStatement (“EIS”) was required and ignored by FDA replied: “These comments reflect amisunderstanding of the action FDA is taking in this final rule and it obligations under NEPAfor such action. The comments presume that FDA has a general obligation under NEPA, in thecontext of promulgating this final rule, to assess the impacts of mercury on the environment andthe effects of any continued introduction of mercury attributable to dental devices. FDA disagreeswith such a presumption, particularly where there is ‘no reasonably close causal relationship’between the actions in the final rule and such general impacts.” (Citing, Department of Transp.v. Public Citizen, 541 U.S. 752, 767, (2004).) However, the cited case does not support FDA’sposition. Unlike the FDA, the agency in the DOT case had no control over the allegedenvironmental contamination at issue. The Court held that because FMCSA lacked discretion toprevent cross-border operations of Mexican motor carriers, neither NEPA nor the Clean Air Actrequired FMCSA to evaluate environmental effects of such operations. FMCSA had no statutoryauthority to impose or enforce emissions controls or to establish environmental requirementsunrelated to motor carrier safety. Motor Carriers Safety Improvement Act of 1999, § 101(a), 113Stat. 1750; 49 U.S.C.A. § 13902(a)(1).

In the case of dental amalgam, FDA may ban the product, require that separators be usedin dental offices, warn about improper discharge of the product, or limit the use of mercury fillingsthus alleviating the environmental impact. FDA’s reliance on the DOT case is misplaced.

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