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Local 2050 of the National Federation
of Federal Employees (hereinafter referred to as "NFFE" or
"the Union") is a Union of dedicated professionals at the
Environmental Protection Agency (hereinafter referred to as "EPA"
or "the Agency") headquarters, including toxicologists, chemists,
physical scientists, statisticians, biologists, engineers and attorneys.
NFFE is the exclusive representative of scientific and technical employees
at EPA in accordance with the Labor-Management Relations Act, 5 U.S.C.
§7101 et seq (1978). The Union is committed to "the highest
standards of professional conduct in the efficient and truthful pursuit of
the mission of the EPA."1 At the
foundation of the Union lies the recognition that
- the mission of EPA as mandated by
Congress through law is to protect public health and the environment,
- professionals hired by EPA form a
professional community with the legal, seientific, and technical
expertise to recognize and help solve environmental problems, and
- sound professional decision making
requires the open interchange of ideas and proposals by all parties
concerned: EPA management, its professional staff, Congress and the
public.2
NFFE members are charged with
reviewing, evaluating and assessing technical and scientific knowledge in
areas relevant to Agency decision making. They are also responsible for
producing final Agency science and technical findings which comply with
legal requirements, and for presenting such findings to the Agency
Administrator, or his or her representative, charged with achieving
national objectives. Thus, the reputations of professionals represented by
NFFE are dependent upon EPA producing scientifically and technically sound
support documents which are consistent with the mission of the Agency.
NFFE is of the opinion that the
Recommended Maximum Contaminant Level (hereinafter referred to as "RMCL")
for fluoride set by EPA is based on scientific support documents whose
purpose, content and interpretation are open to question. NFFE has
repeatedly attempted to have the Agency reconsider the scientific
assessments and the science based decisions involved in promulgating this
fluoride regulation.3 For example, on October 31, 1985 NFFE
wrote to the Administrator and proposed a seminar devoted to the scientific
support work for the RMCL. In this letter NFFE informed the Administrator
that National Federation of Federal Employees Local 2050 is concerned about
the scientific basis for the newly authorized Recommended Maximum
Contaminant Level (RMCL) for fluoride in drinking water. Our concern is
based on the possible impact of the RMCL on our professional reputations.4
On November 15, 1985, NFFE wrote again
to the Administrator, this time setting forth illustrations of major points
of concern:
First, the literature review missed
significant reports in the published literature. ***
Second, references were used that did not address the subject as claimed.
***
Third, scientific conclusions were made without appropriate documentation
and which contradict the available evidence. ***
Fourth, EPA documents on fluoride appear designed to "support"
the Agency position rather than assess the risks from a scientific data
base.5
On August 26, 1986, NFFE once again
informed the Agency of its concern about the scientific basis of the
fluoride RMCL. The Union requested that EPA agree with NRDC to postpone the
court case pending a review by the EPA Science Advisory Board of the
scientific basis of the regulation. In this letter NFFE stated: The Agency
is presently in court and has responded to the NRDC Brief by asserting that
the court should defer to the Agency position because of the "Agency
expertise." This presents a conflict for NFFE which represents EPA
professionals who are the Agency experts and who the public associates with
any scientific or technical publication by the Agency. NFFE has to choose
between ignoring what it knows full well to be an unsupportable decision
and one which injures the reputation of EPA professionals, or take further
action.6
This letter was the union's "last
attempt at finding a way for EPA to honestly reevaluate the decision on
fluoride in-house."7
Despite numerous attempts by the Union
to open the Agency's channels of communication on the fluoride RMCL issue,
EPA has never been receptive to NFFE's concerns.
The Union has concluded that the Brief
for Respondents (hereinafter referred to as "Respondents' Brief")
does not address serious questions raised by NRDC, but instead advocates a
deferential standard of review. NFFE believes that serious errors were made
by the Agency in setting the fluoride RMCL and that this case should not be
dismissed by the invocation of a doctrine of deference to Agency expertise
inasmuch as the Agency deliberately chose not to base its decision
on relevant expertise.
Thus, the Union is filing a brief as
Amicus Curiae to assist this Court in making an informed determination, to
further NFFE's goal of professional excellence in conformance with its
Statement of Purpose8 and the Code of Ethics for Government
Employees,9 and to safeguard the professional
reputations of Union members.
II . SUMMARY OF ARGUMENT
The deferential standard of review
urged by EPA is inappropriate in this case since EPA failed to base its
decision on its technical expertise, which it was required by law to rely
upon and since its decision changed an interim standard in effect for over
ten years. For these reasons also, the burden of justifying its decision
must fall on EPA. The process by which EPA arrived at the RMCL for fluoride
is scientifically irrational and displays an unprofessional review of
relevant scientific data. The Safe Drinking Water Act requires that an RMCL
must be a reflection of the opinion of health professionals as to the level
of a contaminant at which no known or anticipated adverse effect on the
health of persons will occur, and which allows an adequate margin of safety.
However, the final RMCL for fluoride does not represent a determination
made on the basis of scientific and technical expertise.
EPA's deliberate Choice not to
base its decision on expertise is evident by its failure to follow the
proper process in order to determine an RMCL, and by its disregard of the
opinion of health professionals. First, EPA failed to properly ascertain
the Acceptable Daily Dose (ADD) of fluoride. A proper determination of an
ADD is an essential step in the process of ascertaining the appropriate
level in drinking water. It represents the theoretical highest allowable
intake level of the substance per person per day from any and all sources,
at which no adverse health effects in the population will or may result,
allowing for an adequate margin of safety. EPA did not properly ascertain
this level because it a) did not adequately consider all the known or
anticipated adverse effects of fluoride, including dental and nondental
effects, b) did not conduct a professional review of the available
literature on crippling skeletal fluorosis, c) did not consider the most
susceptible individuals when calculating the level at which no adverse
health effect will occur, and d) did not determine an ADD for susceptible
individuals with an adequate margin of safety.
Second, EPA did not properly calculate
the RMCL to ensure that no one in the population would ingest more than the
ADD from a combination of drinking water and all other sources. This figure
was not correctly ascertained because EPA a) did not incorporate any
figures to reflect exposure to fluoride from sources other than drinking
water, and b) failed to take into account all members of the population
when calculating drinking water intake figures.
Third, EPA impermissibly applied
feasibility and political considerations when calculating the RMCL for
fluoride.
A. The Deferential Standard of Review
Urged by EPA is Inappropriate in this Case
EPA urges the Court to treat this case
by the deferential standard of review ordinarily accorded to decisions
based solely on the technical expertise of an administrative agency. The
EPA is absolutely correct in asserting this to be the usual -- and proper
-- standard. The EPA is wholly incorrect, however, in suggesting that this
standard of judicial humility should apply here, where the EPA, in
accordance with a contradictory interpretation of the statutory
requirements for the determination of an RCML, ignored its expertise and
radically changed an interim standard for fluoride previously in effect for
over ten years.
While according deference to
administrative decision-making, this Court has recognized that it should
not apply unless it is clear that "the agency has exercised a reasoned
discretion, with reasons that do not deviate from or ignore the
ascertainable legislative intent." Lead Industries Assoc. v. EPA,
647 F.2d 1130 (D.C. Cir. 1980), quoting Greater Boston Television Corp.
v. F.C.C., 444 F.2d 841, 850 (D.C. Cir. 1970), cert. denied 403
U.S. 923 (1971).
The Supreme Court recently declared:
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. . . the "deference owed to an
expert tribunal cannot be allowed to slip into a judicial inertia which
results in the unauthorized assumption by an agency of major policy
decisions properly made by Congress." American Ship Building Co.
v. NLRB, 380 U.S. 300, 318, 85 S.Ct. 955, 967, 13 L.Ed.2d 85 (1965).
Accordingly, while reviewing courts should uphold reasonable and
defensible construction of an agency's enabling Act, NLRB v. Iron
Workers, supra, 434 U.S., at 350, 98 S.Ct., at 660, they must not
"rubber-stamp . . . administrative decisions that they deem
inconsistent with a statutory mandate or that frustrate the congressional
policy underlying a statute." NLRB v. Brown, 380 U.S. 278,
291-292, 85 S.Ct. 980, 988-989, 13 L.Ed.2d 839 (1965).
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Here even EPA admits that "an RMCL
is, by law to be based only on health and safety consideration . . ."
(emphasis added).10 Nevertheless, as the analysis of the
EPA decision-making which follows clearly demonstrates, EPA disregarded
that mandate. In so doing, it necessarily opened its decision to judicial
scrutiny.
The Supreme Court has also wisely
cautioned that:
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Expert
discretion is the lifeblood of the administrative process, but unless we
make the requirements for administrative action strict and demanding, expertise,
the strength of modern government, can become a monster which rules with
no practical limits on its discretion.
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Motor Vehicle Mfns. Ass'n, Inc. v.
State Farm Mut. Ins. Co., 463 U.S. 29, 48 (1983), quoting Burlington Truck Lines,
Inc. v. United States, 371 U.S. 156, 167 (1962) (emphasis in original).
EPA cites Environmental Defense
Fund. Inc. v Costle, 578 F.2d 337 (D.C. Cir. 1978) to support its
assertion that the new RMCL for fluoride is subject to great judicial
deference.11 The deference standard employed in Costle
has no place in this case. Unlike the Agency determinations passed upon by
this Court in Costle, the Agency action challenged in this case was
not intended to involve any cost, feasibility or policy determinations.
Costle involved a challenge to interim
regulations under the Safe Drinking Water Act. As this Court correctly
noted in Costle the interim regulations "set maximum contaminant
levels (MCL) . . . 'intended to protect health to the extent feasible,
using technology, treatment techniques, and other means, which the
Administrator determines are generally available (taking costs into
consideration) on the date of enactment of this title.'"12 Thus, the Agency determinations at
issue in Costle necessarily involved considerations of cost, policy
and feasibility.
The words omitted from Respondents'
quote from Costle on pages 26-27 of their brief make this clear. In
its entirety this quote should read:
Agency
expertise and judgment must be applied in determining the optimal balance
between promotion of the public welfare and avoidance of unnecessary
expense.
When reprinted in Respondents' brief
the underlined portion of the latter quote was omitted.
Here, as the Agency recognized, it was
charged with determining a level of fluoride which will "result in no
known or anticipated adverse health effects and which allow an adequate
margin of safety."13 In other words, its conclusions were
to be based solely on scientific and technical considerations. NFFE
contends that its conclusions were not founded upon Agency expertise and this
standard of deference to expertise must not apply.
B. The Burden of Demonstrating that the
RMCL was Derived Solely from Scientific Assessments of Health and Safety
Should be Shifted to EPA
Because the "RMCL is by law based
only on health and safety considerations while an MCL takes feasibility and
cost into consideration,"14 EPA was able to escape an economic
impact analysis and regulatory impact analysis in connection with the RMCL
and was able to considerably narrow scrutiny of its determination. Yet the
enforceable MCL standard, which takes into account feasibility and cost,
and as to which considerably greater scrutiny exists, cannot be any higher
than the RMCL since the RMCL is considered to be a non-controversial
technical assessment made prior to any public (or judicial) intervention.
This entire process, however, is based on the supposition that the Agency
professionally ascertained the RMCL by objective scientific standards. NFFE
asserts that no such professional assessment occurred here. The EPA,
without scientific basis, reversed its ten-year standing maximum
contaminant level for fluoride in the face of overwhelming scientific
evidence to the contrary only a short period after the OMB and South
Carolina requested that the previous lower standard be entirely eliminated.
NFFE submits that EPA's decision is flawed on its face and that the burden
of justification should therefore fall on the Agency.
C. The Process by Which EPA Arrived at
the RMCL for Fluoride Is Irrational
This case involves a challenge to the
Recommended Maximum Contaminant Level (RMCL) for fluoride promulgated by
the EPA as part of the "Revised National Drinking Water
Regulations" under SDWA. The promulgation of RMCLs for contaminants of
drinking water is an "initial step" in the rulemaking process.
RMCLs are to represent non-enforceable health goals which are to be set at
a level which assures "that the health of persons will be protected
against known or anticipated adverse effects [of the substance], allowing
an adequate margin of safety." 15
For those contaminants which "may
have any adverse effect on the health of persons," RMCLs are to be set
at a level at which no known or anticipated adverse effects on the health
of persons occur and which allows an adequate margin of safety.16
By requiring the Agency to arrive at
two figures for each contaminant -- an RMCL as a health goal and an MCL as
an enforceable standard -- Congress intended to ensure that each RMCL be
"based solely on considerations of public health and . . . not
influenced by political, budgetary or other considerations."17
The language of the Act and its
legislative history make clear that an RMCL must be a reflection of the
opinion of health professionals as to the level of a contaminant at
which "no known or anticipated adverse effects on the health of persons
occur and which allows an adequate margin of safety."18 Therefore, the Court need not give any
deference in this case to the Agency's "line-drawing" between
"promotion of the public welfare and avoidance of unnecessary
expense."19 Instead, the only question to be asked
is whether the RMCL for fluoride is based on a proper exercise by the
Agency of its scientific and technical expertise.
The scientific and technical employees
at the EPA submit that the Agency abused its discretion in the process of
setting the new fluoride RMCL. The final RMCL does not represent a
determination made on the basis of scientific and technical expertise.
Instead, it represents an administrative process replete with inaccurate
interpretations of the requirements of the Act, inappropriate applications
of political and budgetary considerations, and unprofessional scientific
support documentation.
In simplest terms, the process by which
an RMCL is determined for a given substance should consist of two parts.
First, one must come up with a figure which represents the Acceptable Daily
Dose (hereinafter referred to as "ADD") for the substance.
Second, one must determine the concentration of the substance in drinking
water which will ensure no one ingests more than the ADD from all sources
of the substance combined. The entire process should be conducted through
professional assessment of the relevant scientific and technical literature
and should not involve feasibility or political considerations.
1. EPA failed to properly ascertain the
Acceptable Daily Dose of Fluoride
The first step to arriving at an
appropriate RMCL for a substance is to derive a figure which represents the
theoretical highest allowable intake level of the substance per person per
day from any and all sources. This figure should be set at a level at which
no adverse health effects in the population will or may result, allowing
for an adequate margin of safety. This figure is referred to as the
Acceptable Daily Dose (ADD).20
Several determinations must be made in
order to come up with an appropriate ADD. These include the following:
What are the known and/or reasonably
anticipated adverse health effects of the substance?
At what daily intake level do such
effects occur on the most sensitive individuals in the population? (ie.
What is the No Observed Effect Level (NOEL)?)
At what daily intake level will all
people be protected by an adequate margin of safety? (ie. What is an
Acceptable Daily Dose (ADD)?)
a. The EPA did not adequately consider
all the known or anticipated adverse health effects of fluoride.
The RMCL for fluoride set by EPA on
November 14, 1985 is designed to protect people in this country only from
crippling skeletal fluorosis.21 The Agency declined, however, to
calculate an RMCL intended to prevent the occurrence of other effects,
including dental fluorosis (mottling, discoloration or pitting of teeth),
mutagenic effects, or carcinogenic effects. The procedure by which these
effects were dismissed by EPA was unprofessional and was not in compliance
with the SDWA.
1) Dental Fluorosis
The Director of the Office of Drinking
Water at EPA conveyed information to the Administrator by memo showing that
the effects of dental fiuorosis are "potential causes of adverse
psychological and behavioral problems."22 The memo also disclosed that there is
anecdotal evidence of loss of tooth function and tooth mortality in adults.23
The evidence presented to EPA on dental
fluorosis leads the health professionals of the Union to the conclusion
that dental fluorosis can reasonably be anticipated to result in
adverse health effects.
At EPA's request an independent panel
of behavioral scientists convened to study the psychological and behavioral
effects of dental fluorosis. This ad-hoc panel concluded that people who
have suffered impaired dental appearance as the result of moderate to
severe fluorosis are at increased risk for psychological and behavioral
problems and difficulties.24
EPA also had evidence that a panel of
experts in endocrinology, toxicology, pediatrics, bone metabolism and
fluoride metabolism, convened by the Surgeon General at EPA's request,
concluded that "mottling or pitting of teeth could represent as yet
unknown skeletal effects in children and that severe dental fluorosis per
se constitutes an adverse health effect that should be prevented."25
Such evidence shows that dental
fluorosis should, at least, "reasonably be anticipated" to be an
adverse health effect of fluoride. In his memo to Ruckelshaus, Kimm
acknowledged that a protective approach would lead to considering at least
severe dental mottling as an "adverse effect."26
Yet EPA did not adopt a protective
approach. Instead, the Agency declined to set an RMCL for fluoride which is
designed to protect children from the effects of mottling, discoloration or
pitting of teeth. In so doing the Administrator disregarded the unambiguous
opinion of health experts and stated: "the evidence is inadequate to
conclude that dental fluorosis is an adverse health effect."27 With reference to the effects on
mental health, EPA arbitrarily dismissed the advice of the panel convened
at its own request and decided that "[t]here is inadequate evidence to
conclude that dental fluorosis leads to psychological and behavioral
effects."28
EPA impermissibly applied a conclusive
proof standard when confronted with the scientists' opinion on the
psychological and behavioral effects of dental fluorosis. The Adminstrator
concluded "there is not sufficient evidence that dental fluorosis does
lead to any psychological or behavioral effects."29 Thus EPA articulated its position that
proof must be shown that fluorosis does lead to adverse health
effects rather than may lead to adverse health effects before the
Agency will consider such effect when calculating an RMCL. To require
conclusive proof in setting an RMCL is to disregard the Agency's obligation
under the Safe Drinking Water Act. The Act provides that the RMCL should be
set to protect against "known and anticipated" adverse health
effects.30 Moreover the legislative history makes
clear that "the Administrator must decide whether any adverse effects can
be reasonably anticipated, even though not proved to exist."31
2) Non-Dental Effects
EPA was aware, as Kimm's memo to
Ruckelshaus makes evident, that "many questions . . . surround the
non-dental effects of fluoride."32 As was pointed out to the
Administrator:
Other health effects have been
identified as being potentially associated with fluoride. These effects
include cardiotoxicity effects, thyroid damage, growth retardation, kidney
disease and others.***
There are a series of potential health
issues that presently are not quantifiable, but which may be fundamentally
important. These include the increased susceptability (to fluoride
toxicity) of persons with renal impairment, accelerated transplacental
transfer of fluoride in pregnant women, and fluoride induced effects on
skeletal maturation and growth in children due to amplification of
osteosclerotic effects during periods of high bone remodeling, i.e., ages
0-9.33
Nonetheless, EPA denied that these
effects are associated with fluoride exposure. The following discussion
provides illustration of EPA's unprofessional review with respect to two important
potential adverse effects of fluoride.
a) Mutagenicity
EPA inappropriately omitted
mutagenicity as a possible adverse health effect of fluoride when
calculating the fluoride RMCL. The Agency declined to consider possible
mutagenetic effects of fluoride because it concluded that an unequivocal
determination of the mutagenicity of fluoride cannot be made.34
However, as discussed above, the Safe
Drinking Water Act does not permit the Agency to apply a conclusive proof
standard when determining possible adverse health effects of contaminants.
This standard of proof is also inconsistent with the Agency's own
interpretation of the Safe Drinking Water Act. Respondents state in their
brief that the Act requires EPA to regulate for effects which, although not
proved, are likely to occur in humans and 2) for which there is equivocal
evidence as to whether the effect will occur in humans.35
The process by which EPA arrived at the
conclusion that fluoride is not a mutagen is suffused with errors which
demonstrate a lack of professional review on the part of the Agency. Among
these errors are the following:
First, EPA used abstracts of studies in
lieu of actual reports. Three out of the 18 documents36 on mutagenicity which were cited by
the Agency in the Final RMCL37 for fluoride are abstracts.38 As EPA has acknowledged in the
Response to Comments on its proposed RMCL for fluoride,39 an abstract "precludes a critical
evaluation of these findings due to the lack of details of the experimental
methodology utilized."
Second, EPA used studies that were
never peer reviewed. An additional three out of the remaining 15 articles
used by EPA for its mutagenicity assessment in the final RMCL were
unpublished studies.40
Third, EPA used studies that were
clearly deficient. Three and one half41 of the remaining twelve studies used
by EPA in reviewing mutagenicity of fluoride were clearly deficient. One
aspect of a report relied on by EPA written by G.R. Martin et al.42 utilized the results of the "Ames
test" in arriving at its findings. The originator of the test (Bruce
Ames) has stated that the Ames test is not appropriate for fluoride.43 Moreover, EPA cited a study written by
Kanematsu et al.44 which it criticized in the Response to
Comments document, stating "No dose-response information is provided
by the authors which would allow independent evaluation and their [sic]
results."45 In addition, the Slacik-Erben and Obe46 study should not have been used by EPA
because the Agency had previously stated that the study "has several
serious deficiencies which make the results questionable."47 With respect to the study by Vogel48 EPA acknowledged that "the
observations in the [Vogel 1973] study have recently been shown to be
artifactual."49 Thus, none of these studies should
have been relied on by EPA.
Out of the remaining 8-1/2 studies
used, the Agency has acknowledged that six reports showed fluoride to be a
mutagen and 2-1/2 showed fluoride not to have mutagenic effects.50 Certainly the evidence actually used
by EPA in the Final RMCL added up to the conclusion that mutagenicity is an
adverse health effect that is, at a minimum, likely to occur from fluoride
consumption. To make matters worse, EPA left many important studies out of
its analysis.51 These studies were never appropriately
reviewed by the Agency prior to their rejection. EPA only reviewed
abstracts of the articles and went no further. As conceded by the Agency,
reliance on an abstract "precludes a critical evaluation" of the
study involved.52 EPA stated that the actual studies
were never reviewed because they were not available to the Agency.53 However, these studies are in fact
easily available through the EPA library or the Agency's literature search
capability.
When the studies never properly
reviewed by the Agency are added to those actually usable, 18 out of the
21-1/2 studies show that fluoride is a possible mutagen. Thus EPA was not
justified in declining to include mutagenicity among the adverse health
effects associated with fluoride exposure.
An examination of the studies cited in
EPA's Response to Comments also reveals a striking lack of professional
review by the Agency. Out of the 47 laboratory studies listed, 20 are shown
to be either abstracts, not available to the Agency, or unpublished.54 Moreover, several important studies
appear to have never been looked at by the Agency. For example, an article
referred to by EPA by Kanematsu, supra, was superseded by a later
article showing positive mutagenicity in a more specific study.55 In addition, EPA failed to acknowledge
that a study relied on by it to show negative effects of fluoride on sister
chromatid exchange, also concluded that fluoride caused isochromatid gaps
and chromosome breaks.56.
b) Carcinogenicity
The Agency's decision not to consider
carcinogenic effects of fluoride when calculating the fluoride RMCL was
inappropriate. As EPA acknowledged in issuing its final RMCL57, eleven out of thirteen papers it
considered when assessing the cancer risk of fluoride concluded that
fluoride is oncogenic. The Agency relied solely on one report, however, in
concluding that there is not adequate information to conclude that fluoride
presents a cancer risk to humans.58
EPA never adequately dealt with the
eleven studies showing that fluoride is oncogenic. Among the studies which
were ignored is a paper showing that fruit flies treated with fluoride had
an increased occurrence of cancer.59 This study was funded by the National
Cancer Institute and was conducted by a leading geneticist in the United
States who is also an author of several textbooks on genetics. EPA
dismissed the findings of this report by concluding that the relevance of
data showing incidence of melanotic tumors in fruit flies as a result of
sodium fluoride "has not been scientifically determined."60 This blanket dismissal of the findings of Herskowitz and
Norton is inconsistent with the protective nature of an RMCL and displays a
lack of professional review. Certainly the fact that sodium fluoride
produced melanotic tumors in fruit flies is not insignificant. A
professional charged with assessing human cancer risk of a substance should
deem such data relevant enough to produce concern.
Another paper demonstrated an increase
in tumor growth in mice who received 1/2 to 1 ppm of fluoride in their
drinking water.61 EPA summarily dismissed these findings
and stated that since independent statistical analysis of this data
demonstrated that the effects were not dose-related, it was suggested that
the effects of this study were not related to the administration of sodium
fluoride after all.62 As a scientific or purely logical
matter, however, the fact that the test data do not show a dose-response
relationship, does not preclude the possibility that the effect stemmed
from the substance administered. Thus EPA's objection to such study does
not suffice to dismiss its implications in light of the protective purpose
of an RMCL.
Still another study suggested that
fluoridation of drinking water supplies is responsible for 10,000 to 20,000
excess cancer deaths per year in the United States.63 EPA inaccurately rebutted the findings of this study by
citing Oldham and Newell64 as a
valid criticism of the report.65 As NFFE has pointed out to the Agency,
"The Oldham and Newell study was, however, published one month before
the Yiamouyiannis and Burk study and referred to their previous work
published in 1975."66 A
report by Strassburg and Greenland67 is also cited as a criticism. As the
Union has previously informed the Agency, the latter article
"contained no reference to the Yiamouyiannis and Burk study of
1977."68
Finally, one study not used by EPA, by
Duffey et al., which appeared in a well respected medical journal, reported
that a human patient on sodium fluoride therapy for osteoporosis was found
to have giant cells in her bone marrow "suggestive of a
reticuloendothelial malignancy . . ."69 By way of response to NFFE's objection
to the omission of the latter report, the Director of the Office of
Drinking Water stated by letter that the Duffey report "is not
concerned with cancer or tumor growth."70 The first page of the article
(attached) contains the following sentence: A few giant monocytoid cells,
suggestive of a reticuloendothelial malignancy were discovered.
Once again the lack of professional
review is evident.
b. EPA did not conduct a professional
review of the available literature on crippling skeletal fluorosis.
EPA's brief contends that in
establishing the RMCL, the Agency "carefully evaluated all the
available health evidence relating to skeletal fluorosis."71 Among the evidence which was not
included in this review was a large body of epidemiological research on the
skeletal effects of fluoride in India.72 As an indication of what EPA had
access to but ignored in the rulemaking, a small sample of the extensive
Indian epidemiological literature on skeletal fluorosis, which the Agency
never cited, is listed at Attachment M. Although EPA asserts that there are
only "four studies associating fluoride in drinking water with
crippling skeletal fluorosis in India."73, nine of the Indian studies listed in
Attachment M document severe and crippling skeletal fluorosis, with
symptoms including rigidity of the spine and joints, inability to close
cysts, and crippling deformities. Two of the studies that show severe and
crippling skeletal fluorosis are appended to this brief as Attachment N.
c. EPA did not consider the most
susceptible individuals when calculating the No Observed Effect Level of
crippling skeletal fluorosis.
The Safe Drinking Water Act requires
that in setting an RMCL the Administrator must consider "the existence
of groups or individuals in the population which are more susceptible to
adverse effects than the normal healthy adult."74 The legislative history of the Act
states that in calculating the RMCL for a substance even the most sensitive
individuals in the population are to receive the protection of an adequate
margin of safety. "The incorporation of an adequate margin of safety
is not to be confused with the anticipation of adverse health effects."75 Thus, Congress contemplated a "three-step
process".
First, the known adverse health effects
of contaminants are to be compiled.
Second, the Administrator must decide
whether any adverse effects can be reasonably anticipated, even though not
proved to exist. It is at this point that the Administrator must consider
the possible impact of . . . the existence of more susceptible groups in
the population.
Finally, the recommended maximum level
must be set to prevent the occurrence of any known or anticipated adverse
effect. It must include an adequate margin of safety, unless there is no
safe threshold for a contaminant. In such a case, the recommended maximum
contaminant level should be set at the zero level.76
In order to ensure that all members of
the population are protected by a margin of safety it is necessary to
determine first the figure at which even the most sensitive persons will
not suffer any adverse effects (the No Observed Effect Level - or NOEL)
before determining what margin of safety should apply to that figure.77 EPA did not do this calculation in
order to arrive at the Acceptable Daily Dose for fluoride. In fact, the
Agency never considered sensitive individuals in calculating the fluoride
RMCL.
EPA set the NOEL at 20 mg/day and
stated: "Crippling skeletal fluorosis is an adverse health effect
which results from intakes of fluoride at 20 mg/day over periods of 20
years or more."78 By the Agency's own admission, this
figure is too high. EPA acknowledged that crippling skeletal fluorosis has
been observed in the United States where daily consumption of fluoride was
somewhere between 14.4 and 21 mg.79 EPA also boldly stated:
The Agency agrees that certain segments
of the general population may be at increased risk from waterborne
fluoride.80
Thus EPA set the Acceptable Daily Dose
at a level at which it knew adverse effects would occur.
d. EPA did not determine an ADD for
susceptible individuals with an adequate margin of safety.
The Administrator belied the mandate of
the SDWA when it stated: The Agency feels that this RMCL provides an
adequate margin of safety except in those very extreme cases involving
severely renally impaired individuals . . . 81
The Agency repeatedly cites the fact
that "only two" cases of crippling skeletal flourosis have been
observed in this country to support its conclusion that "the
population at risk at 4 mg/L is negligible."82 However, the statute requires that the
RMCL be set at a level where no adverse effects occur, allowing for
an adequate margin of safety.
EPA stated in the Response to Comments
that "a safety factor of 2.5 will provide protection against crippling
skeletal fluorosis with 'an adequate margin of safety.'"83 The Agency does not show how this
factor was used in any calculation. The reason for this failure is obvious
if the arithmetic is done. A safety factor of 2.5 applied to the 20 mg
figure (after which adverse health affects are said to occur) results in an
Acceptable Daily Dose of 8 mg/day.84 This means that at the RMCL of 4
mg/liter, the ADD (which incorporates the safety factory) will be exceeded
by anyone drinking over 2 liters per day at the RMCL, without even
considering the concentration of fluoride from other sources.
2. EPA did not properly calculate the
RMCL
Once the ADD is ascertained it then
becomes necessary to determine the RMCL - namely: What is the maximum
amount of the substance that should be allowed in drinking water to ensure
that no one will ingest more than the ADD from a combination of drinking
water and all other sources?
Several important questions must be
answered before this assessment can be made. Among these are the following:
What is the maximum amount of the
substance a person might be expected to ingest from sources other than
drinking water?
What is the maximum amount of drinking
water a person might be expected to consume per day?
a. The Administrator did not
incorporate any figures to reflect exposure to fluoride from sources other
than drinking water.
As the Administrator acknowledged,85 fluoride is found in virtually all foods.
It is also contained in many toothpastes and occurs in unusually high
concentrations in tea and fish.
One of the reports considered by the
EPA in calculating the fluoride RMCL concludes: Certain foodstuffs and
beverages are rich in fluoride; e.g. sardines, tea. A 50 gram portion of
canned sardines could contribute 0.8 mg fluoride; in Britain particularly,
many people receive more than 1 mg fluoride daily from drinking tea.86
Moreover, the National Research Council
of Canada reported that British teenagers have an estimated mean daily
intake of fluoride from toothpaste of .32 mg with "an extreme high of
5.0 mg."87 The Council recommended that estimates
of fluoride intakes by adults in North America from foods should
approximate 1.5 to 2.75 mg/day. "Such estimates should include the
caution that these intakes may be exceeded by . . . copious tea drinkers
. . ."88
In order to properly decide on a figure
which represents the contribution of fluoride from nondrinking water
sources, it is necessary to (a) determine the maximum amount of
fluoride found in each source, (b) determine the maximum amounts of each
source that are being ingested by people in the United States and (c)
calculate the total contribution from these sources. However, the EPA did not
include these determinations in its calculation of the fluoride RMCL.
Notwithstanding the existence of
outside sources of fluoride, as well as wide variations of intake from such
sources in the population (due to variations in diet, income and personal
habits), the EPA failed to incorporate such data into its calculation of
the fluoride RMCL. The Administrator simply concluded while food can be a
significant source of fluoride in unusual cases, the Agency believes that
it is unnecessary to adjust the RMCL because of dietary exposure.89
At the same time, the EPA acknowledged
"it is estimated that the development of crippling skeletal fluorosis
requires the daily consumption of 20 mg or more of fluoride from all
sources for 20 or more years."90
The Agency's failure to adjust for
non-drinking water sources is improper and is not in conformance with the
mandate of the Act. The statute makes clear that EPA must include an
evaluation of exposure to a contaminant in media other than drinking water
in calculating an appropriate RMCL.91 "[T]he Administrator must
consider the possible impact of . . . multi-media exposures."92 The failure to incorporate data for
contribution from other sources also runs afoul of the Agency's own
statement of appropriate procedure. EPA has stated: To determine the RMCL,
the contribution from other sources of exposure, including air and food,
should be taken into account.
When sufficient data are available on
the relative contribution of other sources, the RMCL is determined as
follows: RMCL = (ADD) - (contribution from food) - (contribution from air).93
Even assuming that the Agency is
correct in using 20 mg/day as the figure below which no adverse health
effects will result94, and in using a safety factor of 2.5,95 the RMCL has been set too high. Using
EPA's own equation, and assuming a fluoride contribution from other sources
at 2.4, anyone drinking over 1.4 liters/day at the RMCL will be consuming
more than the Acceptable Daily Dose of Fluoride.
b. EPA failed to take into account all
members of the population when calculating drinking water intake figures.
In order to satisfy its obligation to
come up with an RMCL which ensures "no known or anticipated
adverse effects on the health of persons occur and which allows an adequate
margin of safety" the RMCL must be designed to protect all members of
the population. Thus it is necessary to calculate drinking water intake
figures on the basis of the maximum amount of water an individual could be
expected to consume.
As EPA acknowledges, the drinking water
intake figure of 2 liters per day, on which the fluoride RMCL is based,
does not represent the maximum intake level in the population, but what EPA
believes to be the "average" amount of water consumption.96 EPA also states that: over 95% of the
population are believed to consume 4 liters per day or less, over 99% of
the population are believed to consume 5.5 liters or less.97
These figures are based on an internal
memo from Paul S. Price, to Arthur B. Perler, dated March 4, 1985. The
Price memo gives the results of a Tolerance Assessment System (TAS) survey
of water consumption patterns in the population. The tables from this
survey, reprinted in the Price memo, show that approximately 50% of adult
males in the population drink more than two liters a day. In fact, one out
of every one hundred males consumes over 5.52 liters per day.98 Nonetheless, EPA concluded that it
need not consider individuals who consumed more than the
"average" amount of water when calculating the RMCL.99
In utilizing a figure which it believes
represents the average drinking water intake of the population to compute
the RMCL for fluoride, the EPA has failed to follow the requirements of the
statute. The statute provides that the RMCL will be set at a level at which
no adverse health effects occur. This scheme requires that all people in
the population be protected with an adequate margin of safety. However, EPA
calculated the RMCL for fluoride on the basis of a water consumption figure
which it acknowledges is inaccurate for half of the adult males in the
population.
It is inappropriate to dismiss this
error, as EPA tries to do, by claiming that persons drinking more than two
liters per day are protected by the margin of safety.100 To do so is to commit just the type of error which Congress
warned against: The incorporation of an adequate margin of safety is not
to be confused with the anticipation of adverse health effects.101
Once again, by plugging appropriate
figures into EPA's own equation, the inadequacy of the RMCL becomes
obvious. One out of every one hundred males in the population who drink
water at the RMCL of 4 mg/liter will be ingesting over 22 mg of fluoride
from drinking water alone, not even including the estimated 2.4 mg per day
they will consume from outside sources. Thus the total daily consumption of
fluoride from all sources for these men will be over 24.4 mg, a level at
which adverse health effects are said to occur, and an amount which is more
than three times the level EPA has determined to be an Acceptable
Daily Dose.102
3. EPA impermissibly applied
feasibility and political considerations when calculating the RMCL for
fluoride.
The SDWA requires that RMCLs be based
purely on considerations of health. However, a memo from the Director of
the Office of Drinking Water to the Administrator of EPA shows that the
determination of the fluoride RMCL by the Agency was imbued with political
and feasibility concerns.103
The memo requests guidance on whether
dental fluorosis is to be considered an adverse health effect of fluoride
in light of the determination of an ad-hoc panel of behavioral scientists
that mental health problems could be expected due to dental fluorosis.
The memo presents three options to the
Administrator:
1. Conclude that no adverse health
effects occur from fluoride exposure and drop the MCL; list as a secondary
standard and perhaps require monitoring and public notification.
2. Conclude that crippling skeletal
flourosis is the adverse health effect and set the RMCL.
3. Conclude that moderate and severe
dental fluorosis is an adverse health effect and set the RMCL.
Significantly, the memo also includes a
breakdown of the "Impacts" of these alternatives. One table
attached discusses the cost implications at various configurations of the
RMCL and MCL. Another attached table discusses the "Legal Challenge
Potential" at several different levels of RMCL and MCL.
What this memo shows is that in setting
the RMCL for fluoride, EPA did precisely that which Congress had directed
it should not do -- it applied considerations other than those required for
the protection of public health. The legislature did not mean for the RMCL
and MCL to be considered together. Its mandate was that the process by
which each standard was set should be distinct.
In the Committee's view, the question
of what is necessary for adequate protection of the public health is and
ought to be considered separately from the question of what degree
of contaminant control is technologically or economically feasible.104
As is evident by the above-mentioned
memo, the Administrator's decision to set the flouride RMCL at 4.0 mg/liter
was made for reasons expressly prohibited by the statute.
IV. CONCLUSION
For the reasons stated above, the
Agency's decision to establish the RMCL for fluoride at 4mg/L should be
reversed and the matter remanded with a directive to the Agency to set a
new RMCL in a manner consistent with its statutory duties.
Footnotes
- Statement
of Purpose, National Federation of Federal Employees, EPA
Professionals, Local 2050 (hereinafter referred to as "Statement of Purpose.")
- Statement of Purpose.
- See Attachments B through G.
- Letter from Robert J. Carton to Lee M.
Thomas (Oct. 31, 1985).
- Letter from Robert J. Carton to Lee M.
Thomas (Nov. 15, 1985).
- Letter from Robert J. Carton to Lee M.
Thomas (Aug. 26, 1986).
- Letter from Robert J. Carton to Lee M.
Thomas (Aug. 26, 1986).
- Through its Statement of Purpose NEFE is dedicated
"to the highest standards of professional conduct in the
efficient and truthful pursuit of the mission of EPA." This
document also provides:
In
order to achieve [its] goals, this organization recognizes that all
professional employees have . . . the responsibility to participate in
building and improving [the EPA work] environment, making it more efficient
and effective for the benefit of the entire EPA community and the public
they serve.
Statement
of Purpose, supra.
- The first rule set forth by the Code
of Ethics for Government Service is that Government employees should
I. Put loyalty to the highest moral
principles and to country above loyalty to persons, party, or Government
department.
Pub. L. 96-303, §§ 1-4, July 3, 1980, 94
Stat. 855, 856.
- Final RMCL at 47155.
- Respondents' Brief at 26-27.
- Costle, supra, 578 F.2d at 339-340.
- Final RMCL at 47142.
- Final RMCL at 47155.
- H.R. Rep. No. 93-1185, 93d Cong., 2d
Sess. 18 (1974) (hereinafter referred to as "House Report").
- § 1412(b)(1)(B), 42 U.S.C.
§300g-l(b)(1)(B). 1
- House Report at 19.
- § 1412(b)(1)(B), 42 U.S.C.
§300g-l(b)(1)(B).
- Environmental
Defense Fund. Inc. v. Costle, 188 U.S. App. D.C. 95, 578 F.2d 337 (1978).
- See National Primary Drinking Water
Regulations; Synthetic Organic Chemicals, Inorganic Chemicals and
Microorganisms; Proposed Rule, 50 Fed. Reg. 219, 46944 (1985) (to be
codified at 40 C.F.R. Part 141) (proposed Nov. 13, 1985). Here EPA
provides that "[f]or toxic agents not considered to have
carcinogenic potential, "no effect" levels for
chronic/lifetime periods of exposure including a margin of safety are
referred to commonly as ADIs or Acceptable Daily Intakes." EPA
calculates ADIs in terms of mg/kg/day. In the discussion above, we are
simplifying this method by assuming the weight of a 70 kg adult. EPA's
ADI, for an assumed 70 kg adult results in what we refer to above as
the Acceptable Daily Dose (ADD).
- The EPA admits crippling skeletal
fluorosis occurs in the population when daily consumption of fluoride
exceeds 20 mg/day. See National Primary Drinking Water
Regulations; Fluoride, 50 Fed. Reg. 220, 47144 (1985) (to be codified
at 40 C.F.R. Part 141) (hereinafter referred to as "Final
RMCL").
- Memorandum from Victor J. Kimm to
William D. Ruckelshaus (undated) (hereinafter referred to as
"Kimm Memo") (See Attachment H).
- Kimm Memo. Another illustration of
concern by Agency experts over the dental effects of fluoride is the
fact that a reference dose (RfDs) for oral exposure was, in fact,
calculated at a level which would protect children from dental
fluorosis. See Verified Reference Doses (RfDs) of the U.S. EPA,
May 13, 1986 (attached) (hereinafter referred to as "Verified
Reference Doses") (See Attachment O).
- Final RMCL at 47144.
- Draft Report to the Surgeon General of
the Ad Hoc Panel of the Non-Dental Health Effects of Fluoride in
Drinking Water, May 26, 1983 (See Attachment I).
- Kimm Memo.
- Final RMCL at 47143.
- Final RMCL at 47144.
- Final RMCL at 47144 (emphasis added).
- § 1412(b)(1)(B), 42 U.S.C. §
30Og-l(b)(1)(B).
- House Report at 20 (emphasis added).
- Kimm Memo.
- Kimm Memo.
- Final RMCL at 47150.
- Respondents' Brief at 59.
- EPA mentioned 21 studies in its
mutagenicity discussion. However, the following three were mentioned
twice: 1) Martin, G.R., Brown, K.S., Matheson, D.W., Lebowitz, H.,
Singer, L., Ophaug, R., "Lack of Cytogenetic Effects in Mice or
Mutations in Salmonella Receiving Sodium Fluoride," Mut. Res.,
66:159-157, 1979. 2) Skare, J./A., Wong, T.K., Schrotel, K.R.,
"Lack or Genotoxic Activity of Sodium Fluoride in an In Vitro DNA
Repair Assay and an In Vivo DNA Damage Assay," Environ. Mut. 7:72
(Abstract), 1985. 3) Tsutsui, T., Suzuki, N., Ohmori, M., "Sodium
Fluoride-Induced Morphological and Neoplastic Transformation,
Chromosome Aberrations, Sister Chromatid Exchanges and Unscheduled DNA
Synthesis in Cultured Syrian Hamster Embryo Cells," Cancer Res.,
44:938-941, 1984.
- Final RMCL at 47150-47151.
- 1) Alieve, A.A., Babaev, D.A.,
"Cytogenetic Activity of Vitamins in Bone Marrow Cells of Rat
Femurs in Sodium Fluoride-Induced Mutation Conditions." Chem.
Abs. 98:29471p, 1983. 2) Aliev, A.A., Kuligavin, A.E., Sarina, T.N.,
"Effect of Alpha-Tocopherol on the Level of Chromosomal
Abberations Induced by Sodium Fluoride in Rat Femur Bone Marrow
Cells," Chem. Abs. 96:5274j, 1982. 3) Skare, J.A., Wong, T.K.,
Schrotel, K.R., "Lack of Genotoxic Activity of Sodium Fluoride in
an In Vitro DNA Repair Assay and an In Vivo DNA Damage Assay."
Environ. Mut. 7:72 (Abstract), 1985.
- Summary of Comments and Responses from
the May 14, 1985 RMCL Proposal 101 (hereinafter referred to as
"Response to Comments").
- 1) Ved Brat, S., The Chinese Hamster
Ovary Cell Sister Chromatid Exchange Assay on Sodium Fluoride,"
Unpublished, 1984a. 2) Tong, C., "The Human Skin Fibroblast/DNA
Repair Assay on Compound Sodium Fluoride Using Human Skin Fibroblast
in Culture." Unpublished, 1984. 3) Williams, G.M., "Density
Gradient Centrifugation to Detect DNA Repair in D550 Cells Exposed to
Sodium Fluoride," Unpublished, 1984.
- One of these studies involved two
endpoints, one of which was not deficient.
- Martin, G.R., Brown, K.S., Matheson,
D.W., Lebowitz, H., Singer, L., Ophaug, R., "Lack of Cytogenetie
Effects in Mice or Mutations in Salmonella Receiving Sodium
Fluoride," Mut. Res., 66:159-157, 1979.
- See Letter to Arthur Upton from Bruce
Ames (Oct. 19, 1977), reprinted In The National Cancer Program
(Part 2 - Fluoridation of Public Drinking Water: Hearings Before a
Subcomm. of the Comm. on Government Operations, 95th Cong., 1st
Sess. 243 (1977) (See Attachment J). Note that the Martin report was
not deficient with respect to other tests not related to the Ames
test.
- Kanematsu, B., Hara, M., Kada, T.,
"Rec Assay and Mutagenicity Studies on Metal Compounds,"
Mut. Res., 77:109-116, 1980.
- Response to Comments at 98.
- Slacik-Erbin, R., Obe, G., The Effect
of Sodium Fluoride on DNA Synthesis, Mitotic Indicies and Chromosomal
Aberrations in Human Leukocytes Treated With Trenimon in Vitro,"
Mut. Res., (Complete citation not given), 1976.
- Response to Comments at 99.
- Vogel, E., "Strong Antimutagenic
Effects of Fluoride on Mutation Induction By Trenimon and
1-Phenyl-3.3- Dimethyltriazene in Drosophila Melanogaster," Mut.
Res., 20:39-352, 1973.
- Response to Comments at 99.
- Final RMCL at 47150.
- See Response to Comments at 102-105,
which cites articles as follows: Akundov VY, et al. 1981, Izv. Akad.
Nauk Az. SSR. Ser. Biol. Nuak (4):3-5 (Full citation not available.)
(not available to the Agency.); Aliev AA, Babaev DA. 1981. Tsitol
Genet. 15(6):19-23 (Full citation not available.) (Not available to
the Agency.); Bale SS, Hart GE. 1973. Can. J. Genetics Cytol.
15:695-702 (Full citation not available.) (Not available to the
Agency.); He W. et al. 1983. Huanjing Kexue Xuebao 3(2):94-100. (Full
citation not available.) (Not available to the Agency.); Jagiello G.
Lin J. 1974. Archives of Environmental Health. 29:230-235. (Full
citation not available.) (Not available to the Agency.); Mitchell B.
Gerdes RA. 1973. Fluoride 6:113-117. (Full citation not available.)
(Not available to the Agency.); Mohamad AH. 1966. Genetics Cytol.
8:575-583 (Full citation not available.) (Not available to the
Agency.); Mohamad AH. 1970. Can. J. Genetics Cytol. 12:614-620 (Full
citation not available.) (not available to the Agency.); Mohamad AH.
1970. Proc. 2nd Int. Clean Air Congr. (IUAPPA), Dec 1970, p. 26 (Full
citation not available.) (Not available to the Agency.); Mohamed AH,
et al. 1966. Can. J. Genet. Cytol. 8:241-244 (Full citation not
available.) (Not available to the Agency.); Ragamova GK, et al. 1973.
Izv. Akad. Nauk Az. SSR. Ser. Biol. Nauk (4):21-24 (Full citation not
available.) (Not available to the Agency.).
- Response to Comments at 101.
- See note ____, supra.
- Response to Comments at 102-105.
- Kanematsu, B., Japanese Journal of
Oral Biology, 27:372-374, 1985. "Genetic Toxicity of
Bio-Materials 2. DNA Damage Effects of Sodium Fluoride and Other
Fluoride Compounds."
- Kishi, K., Tonomura, A.,
"Mutagenicity of Sodium Fluoride (NaF) - Review and Human
Lymphocyte Assay." Husso Kenkyu 5:35-41, 1984.
- Final RMCL at 47150.
- Final RMCL at 47150.
- Herkowitz, I.H., Norton, I.L.,
"Increased Incidence of Melanotic Tumors in Two Strains of
Drosophila Melanogaster Following Treatment with Sodium
Fluoride," Genetics, 48:307-310, 1963.
- Response to Comments at 62.
- Taylor, A., Taylor, N.C., "Effect
of Sodium Fluoride on Tumor Growth," Proc. Soc. Exp. Biol. Med.,
119:252-255. 1965.
- Response to Comments at 62.
- Yiamouyiannis, J., Burke, D.,
Fluoridation and Cancer: Age-Dependency of Cancer Mortality Related to
Artificial Fluoridation," Fluoride, 10:102-125, 1977.
- Oldham, P.D., Newell, D.J.,
Fluoridation of Water Supplies and Cancer - A Possible
Association?" Appl. Stat. 26:125-135, 1977.
- Response to Comments at 59.
- Letter from Robert J. Carton to
Michael R. Cook (undated).
- Strassburg, M.A., Greenland, S.,
"Methodological Problems In Evaluating the Carcinogenic Risk of
Environmental Agents." J. Environ. Bealth 41:214-217, 1979.
- Letter from Robert J. Carton to
Michael R. Cook (undated).
- Duffey, P.H., Tretbar, H.C.,
Jarkowski, T.L., "Giant Cells in Bone Marrows of Patients on
High-Dose Fluoride Treatments," Annals of Internal Medicine,
75:745-747, 1971 (See Attachment K).
- Letter from Michael B. Cook to Robert
J. Carton (Feb. 6, 1986) (See Attachment L).
- Respondents' Brief at 32. )
- More than one million people in India
are afflicted with various stages of skeletal fluorosis. The maximum
permissible level for fluoride in drinking water in India is 1.0 ppm:
at least one team of Indian experts on skeletal fluorosis has called
for lowering the limit to 0.5 ppm, because, in its view, 1.0 ppm poses
an unreasonable risk of skeletal fluorosis. See Teotia, S.P.S.
and Teotia, M., "Endemic Fluorosis in India: A Challenging
National Health Problem," Fluoride 18-2:125-127, at 125, 1985
(Abstracted from J. Assoc. of Physicians of India, 32:347-52, 1984).
- Respondents' Brief at 38.
- § 1412(e)(3), 42 U.S.C. 30Og-1(e)(3).
- House Report at 20 (emphasis added).
- House Report at 20.
- This margin of safety is applied in
order to compensate for uncertainty in the data.
- Final RMCL at 47144.
- "[C]rippling skeletal fluorosis
was noted in both a 55 year old male and a 64 year old male. . . . The
amount of water consumed is estimated by the EPA to be 6 L per day
containing . . . somewhere between 2.4 and 3.5 mg flouride/L in one
case . . . ." Final RMCL at 47147.
- Final RMCL at 47151.
- Fina1 RMCL at 47152.
- Final RMCL at 47144 and 47151.
- Response to Comments at 11.
- Moreover, EPA scientists have
concluded that "0.12 mg fluoride/kg/day is a safe exposure level
for [crippling skeletal fluorosis]." For a 70 kg adult, this
level amounts to 8.4 mg/day. See Verified Reference Doses at 2.
- Final RMCL at 47145.
- Smith, G.E., "A Surfeit of
Fluoride," Sci. Prog. Oxf. 69:429, 432 (1985).
- National Research Council of Canada,
NRC Associate Committee on Scientific Criteria for Environmental
Quality, "Environmental Fluoride, 1977," page 79
(hereinafter referred to as "Canadian Report").
- Canadian Report at 83.
- Final RMCL at 47145.
- National Primary Drinking Water
Regulations: Fluoride, 50 Fed. Reg. 93, 20170 (1985) (to be codified
at 40 C.F.R. Part 141) (proposed May 14, 1985).
- Section 1412(e)(3), § 30Og-l(e)(3).
- House Report at 20.
- National Primary Drinking Water
Regulations; Synthetic Organic Chemicals, Inorganic Chemicals and
Microorganisms; Proposed Rule, 50 Fed. Reg. 219, 46946 (1985) (to be
codified at 40 C.F.R. Part 141) (proposed Nov. 13, 1985).
- This assumption has been criticized at
pg. 31-34.
- This margin of safety has been
criticized at pg. 34- 35.
- Final RMCL at 47147.
- Final RMCL at 47147.
- Memorandum from Paul S. Price to
Arthur H. Perler (Nov. 12, 1985). EPA acknowledged elsewhere that
there had been at least two cases reported in the United States of
daily water intake of 6 liters/day. See Final RMCL at 47147.
- "EPA does not believe that the
SDWA requires protection by national regulation of persons who,
through unusual practices, may put themselves at risk." Final
RMCL 47178.
- EPA justifies its RMCL by stating
"The Agency believes that the margin of safety in adequate for
these persons based on lack of detection of crippling skeletal
flourosis in any significant portion of the population." Final
RMCL at 47148.
- House Report at 20.
- See pg. 34-35, supra.
- Kimm Memo.
- House Report at 18-19.=
Respectfully submitted,John J. Loflin,
Nora J. Chorover, John Grimmer, LORD, DAY & LORD,
25 Broadway, New York, New York 10004, (212) 344-8480
Dated: New York, New York
Dated: September 3, 1986
STATEMENT OF PURPOSE, NATIONAL
FEDERATION OF FEDERAL EMPLOYEES, EPA PROFESSIONALS, LOCAL 2050
This organization of dedicated
professionals, recognizing that:
- The
mission of EPA as mandated by Congress through law is to protect
public health and the environment,
- Professionals
hired by EPA form a professional community with the legal,
scientific, and technical expertise to recognize and help solve
environmental problems, and
- Sound
professional decision making requires the open interchange of ideas
and proposals by all parties concerned: EPA management, its
professional staff, Congress and the public, hereby dedicates itself
to the highest standards of professional conduct in the efficient and
truthful pursuit of the mission of EPA.
In order to achieve these goals, this
organization recognizes that all professional employees have
- the
right to a work environment that fosters their job performance and
professional growth, and
- the
responsibility to participate in building and improving that
environment, making it more efficient and effective for the benefit
of the entire EPA community and the public they serve.
NATIONAL FEDERATION OF FEDERAL
EMPLOYEES, Local 2050, August 26, 1986
Honorable Lee M. Thomas
Administrator
U.S. Environmental Protection Agency
Washington, D.C. 20460
Dear Mr. Thomas,
As we have already noted in previous
letters, NFFE Local 2050 is concerned about the promulgated Recommended
Contaminant Level (RMCL) for fluoride in drinking water. It is highly
questionable whether this regulation should have been promulgated
considering the inadequate and highly flawed scientific and technical
support documents (and EPA's response to the public comments) upon which
the regulation is based.
The Agency is presently in court and
has responded to the NRDC brief by aserting that the court should defer to
the Agency position because of the "Agency expertise." This
presents a conflict for NFFE which represents EPA professionals who are the
Agency experts and who the public associates with any scientific or
technical publication by the Agency. NFFE has to choose between ignoring
what it knows full well to be an unsupportable decision and one which
injures the reputation of EPA professionals, or take further action.
As noted In the attached resolutlon
passed by the union, NFFE has decided to approach the Science Advisory
Board, who has only recently acquired responsibility for overseeing the
publications of the Office of Drinking Water, to request a review of the
scientific basis for this regulation. If a timely review is not forthcoming
(in time for a 9/3/86 court deadline), then we have been directed to file
an amicus brief with the court citing our opinion on the scientific
inadequacy of this action. A meeting has already been held with Dr. Yosie,
Director of the SAB. who has only agreed to consider our request. He
pointed out that the time constraints would probably prohibit a timely
review.
There does, however, need to be an
alternative, albeit a long shot. The review may be possible if the court
case could be postponed. This of course would require the agreement of the
NRDC who may not want a postponement. One of the questions they might ask
is: are there sufficient experts on this committee who do not have a vested
interest in a fluoride position to carry out an objective review?
We are asking that you seriously
consider this alternative which would allow the review which we feel is so
necesssary. This is our last attempt at finding a way for EPA to honestly
reevaluate the decision on fluoride in-house. We do not believe that it is
in the interest of the Agency or its professionals to wash dirty laundry in
public.
Sincerely,
Robert J. Carton, Ph.D.
President
NFFE Local 2050
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