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EPA Fluoride
Standards Database:
Natural Resources Defense Council Lawsuit Against EPA (1986)
DIRECTORY: Health
> EPA
Fluoride Standards > NRDC Lawsuit (1986)
NOTABLE QUOTES:
"I've never seen scientific
evidence discounted and refused to be looked at the way they're
doing with fluoride."
- Jacqueline Warren, Natural
Resources Defense Council, November 25, 1985
"They're changing the standard
for reasons that have nothing to do with science."
- Jacqueline Warren, Natural
Resources Defense Council, November 25, 1985
BACKGROUND:
In 1985, the EPA -- under strong political
pressure from dental institutions and states with high fluoride
in their water -- increased the safe
drinking water standard for fluoride from 1.4-2.4 ppm to 4 ppm.
The EPA made the change
In response to EPA's alteration of the fluoride
standard, the Natural Resources Defense
Council (NRDC) filed suit against the Agency arguing that the
new, weakened standard was unprotective of public health and a violation
of the Safe Drinking Water Act.
As noted at the time by Jacqueline
Warren, a lawyer with NRDC: "They're changing the standard
for reasons that have nothing to do with science."
A Union
of EPA scientists and professionals agreed with NRDC's arguments,
and in what some considered an unprecedented
move, the EPA scientists
“filed on behalf of the environmentalists, and against the
agency.”
According to the then 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."
Ultimately, however, the Court barred
the EPA Union from joining the suit, and rejected NRDC's suit
on the basis of the deference afforded
to EPA Administration in rulemaking matters.
DOCUMENTS:
SUMMARY of NRDC's ARGUMENT
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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