Fluoride Action Network

EPA/Fluoride Files

FAN's extensive documentary history of EPA's decision in 1985 to increase the allowable levels of fluoride in drinking water. The documents show that EPA Management allowed political pressures to trump the clear consensus among its scientists that the altered standard was not safe.

NRDC Lawsuit

In 1985, the EPA increased the maximum level of fluoride allowed in drinking water to roughly twice the level previously deemed safe. Following EPA’s alteration to the standard, the Natural Resources Defense Council (NRDC) filed suit against the Agency. The NRDC argued that the new, weakened standard was unsafe and a violation of the Safe Drinking Water Act. As noted by NRDC’s attorney. Jacqueline Warren:

“I’ve never seen scientific evidence discounted and refused to be looked at the way they’re doing with fluoride. . . . They’re changing the standard for reasons that have nothing to do with science.”

A Union of EPA scientists and professionals agreed with the NRDC, and in what some considered an unprecedented move, the EPA scientists “filed on behalf of the environmentalists, and against the agency.” According to the President of EPA’s Headquarters Union, Dr. Robert Carton: “Our responsibility to defend EPA professionals’ reputations and to protect public health in this situation requires us to put loyalty to the public interest and to moral principle above loyalty to persons or to [a] government department.”

Although the NRDC did not prevail in this lawsuit, its criticism of the MCL has since been vindicated by the National Research Council (NRC) which, in 2006, concluded that the MCL is unsafe and needs to be lowered. EPA has yet to do so.

The Documents:


The following is a summary of NRDC’s critique – as stated in the introduction of their September 1986 legal brief:

“EPA admits that it has established an RMCL for fluoride at a level which will not protect sensitive subgroups against crippIing skeletal fluorosis and other health effects. This clear violation of the Safe Drinking Water Act (“SDWA” or “the Act”) should be remanded to the Agency for determination of an RMCL consistent with the Agency’s duty to protect susceptible sbbgroups of the population.

EPA claims that only a small number of persons are likely to be harmed by exposure to fluoride at the RMCL. The record shows, however, that fluoride concentrations at and below 4 mg/L could cause crippling skeletal fluorosis and other clinical skeletal effects in a substantial number of people. EPA made no effort to determine the number of people who will be harmed. Instead of evaluating all pertinent information (as it says it did), the Agency ignored documentation of severe skeletal effects in kidney patients, failed to address dangers to other groups such as diabetics, and entirely overlooked potential dangers to children.

The Agency’s own drinking water intake data show significant risk of crippling skeletal fluorosis in populations exposed to fluoride concentrations of 4 mg/l, even when the data are used cautiously. EPA did not mention or show any awareness of the implications of these data. EPA should have set an RMCL to provide a margin of safety for the highest consumers of water; instead, it provided a small margin of safety only for persons who drink 2 liters of water or less per day.

Finally, the two epidemiological studies of skeletal effects of fluoride heavily relied upon by EPA fall far short of demonstrating that fluoride concentrations up to 4 mg/L will not harm a substantial portion of the population. EPA made no effort to ascertain the reliability of the studies; and the Agency’s brief erroneously assumes that the studies “necessarily account for” sensitive subgroups.

EPA’s response to NRDC’s challenge is to ask this Court to defer to the Agency’s judgment and thereby create a judicial exception to the mandate of the SDWA that an RMCL must provide protection to all persons against known and anticipated health effects of drinking water contaminants. The RMCL should be set aside and remanded to EPA for failure to protect sensitive sub-groups, as Congress intended.

EPA’s determination that dental fluorosis is not an adverse health effect of fluoride in drinking water for purposes of the RMCL represents a reversal of Agency policy established in 1975 and reaffirmed in 1981 and 1983. Not only did EPA fail to provide a reasoned analysis of why its prior policy of considering dental fluorosis to be an adverse health effect was no longer well-founded, but the Agency also failed to address the single most important piece of evidence in the record indicating that dental fluorosis is an adverse health effect of fluoride. Ignoring the conclusions of an objective panel of medical experts convened to consider the medical effects of exposure to fluoride in drinking water, the Agency instead relied exclusively upon the advice and opinions of parties who have been major activists on the promotion side of the national controversy over fluoridation of water supplies, despite obvious evidence of bias in their judgments. This Court should not uphold the Agency’s unexplained and unjustifiable reversal of policy as a reasonable exercise of discretion consistent with the preventive intent of the SDWA.

Finally, EPA’s imposition of a functional impairment test to define an adverse health effect of fluoride is not within the range of reasonable interpretations of the SDWA. The Agency made no claim in the rulemaking that it was changing its interpretation of the SDWA so as to require functional impairment as the definition of an adverse health effect of a contaminant — with the exception of fluoride. This interpretation is not only contrary to the clear preventive intent of Congress, but it is also inconsistent with every other statement EPA has ever made of its duties under the Act. These include the particular duty to err on the side of safety when there are conflicting opinions about the medical significance of an effect. The creation of a special definition of an adverse health effect just for fluoride is not entitled to deference by this Court.

The Agency’s treatment of evidence of other possible adverse health effects of fluoride was also tainted by the application of an erroneous evidentiary standard. Applying the unduly stringent functional impairment test and requiring a higher degree of proof than Congress intended, EPA failed to provide protection in the RMCL against a number of potential adverse health effects. Claiming erroneously that the SDWA doesn’t protect against “possible” adverse health effects, EPA also pointed to an allegedly large negative human data base to rebut all evidence of other potential adverse health effects. The Agency’s response ignores other record evidence that the human data base is not extensive, and that critical information is lacking, especially with respect to adverse skeletal and cardiovascular effects in children.

The Agency’s creation of a stringent and unprotective definition of the adverse health effects of fluoride, and its failure to rebut or demonstrate the invalidity of studies indicative of other potential adverse health effects of fluoride, violated the SDWA. The RMCL should be vacated and remanded to EPA for re-evaluation of the evidence consistent with the preventive intent of the Act.”

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