DIRECTORY: Health > EPA Fluoride Standards > Dental Fluorosis

Fluoride Action Network
March 15, 2006

FOCUS on FLUOROSIS
A Political History of EPA’s MCLG

by Michael Connett

On Wednesday, March 22, the US National Research Council (NRC) is expected to release its long awaited report on fluoride. In the report, the NRC will give its assessment of the adequacy of the Environmental Protection Agency’s (EPA) safe water standards for fluoride.

In light of NRC’s impending report, let us take a closer look at the history of the safe water standard -– the “Maximum Contaminant Level Goal” (MCLG) -- which the NRC has been asked to review.

The MCLG is “the level of a contaminant in drinking water below which there is no known or expected risk to health.” In 1985, the EPA set the current MCLG for fluoride at 4 parts per million (ppm), or 4 milligrams of fluoride per liter of water.

The MCLG for fluoride, however, hasn’t always been 4 ppm. In fact, when EPA first established the standard in 1975, it set the level at 1.4-2.4 ppm (a range dependent on the community’s average temperature) in order to protect against moderate/severe fluorosis, an effect which EPA considered adverse to a person’s health.

So why did EPA alter the standard in 1985? Was the alteration based on science, or on politics?

‘The EPA Files’

Answers to these questions are spelled out in a series of EPA documents which the Fluoride Action Network has recently obtained from Dr. Robert Carton, a retired risk assessment scientist at EPA. The documents reveal the following facts:

• The consensus among EPA’s scientists, prior to the setting of the standard, was that the MCLG should not be increased to 4 ppm. Instead of increasing the MCLG, most EPA staff scientists working on the standard wanted to keep it at 2 ppm, or lower it to 1 ppm.
• The State of South Carolina, and various dental groups, lobbied EPA for over 4 years to re-classify dental fluorosis as a “cosmetic” effect and not a “health” effect. Every non-dental group of experts consulted by EPA, however, disagreed with this assessment. The unanimous conclusion – which EPA’s own scientists shared - was that dental fluorosis, in its moderate and severe stages, is an adverse health effect that should not only be prevented by the MCLG, but also by the MCL (the federally enforceable standard). This conclusion was based on the likely psychological ramifications to the impacted child, and the probability that the teeth aren’t the only impacted tissue in the body.

Internal Conflict at EPA: Scientists vs Management

Perhaps nothing better highlights the discontent among EPA scientists and professionals about management’s alteration of the MCLG than the following quote from Paul Price. Price was the EPA analyst who managed the writing, and justification, of the standard. One might think Price supported the decision to increase the standard. After all, he was the one who wrote the standard. This, however, this was not the case.

As Price later told The Progressive Magazine, he and other EPA scientists were “devastated” by management’s decision to raise the standard. This feeling of devastation is readily apparent in the following mock press release that Price circulated among staff scientists on the very day (October 31, 1985) that EPA issued its official press release announcing its decision to raise the MCLG to 4 ppm.

"Up to now EPA, under the Safe Drinking Water Act, has regulated fluoride in order to prevent children from having teeth which looked like they had been chewing brown shoe polish and rocks. The old standard which was based upon the consumer's average shoe size and the phase of the moon, generally kept fluoride levels below 2.4 mg/L. EPA in response to new studies, which only confirmed the old studies, and some flat out political pressure, has decided to raise the standard to 4 mg/L. This increase will allow 40% of all children to have teeth gross enough to gag a maggot. EPA selected this level based upon a cost effectiveness study which showed that it is cheaper for people to keep their mouths shut then to remove the fluoride." See memo

Price’s view that EPA should not set the MCLG at a level (4 ppm) where 40% of children will get moderate to severe dental fluorosis (brown to black discoloration of teeth with pitting and erosion of enamel), was a view shared by virtually all non-dental scientists consulted by EPA, as well as EPA scientists themselves. Here, for instance, is a chronology of the recommendations on fluorosis given to EPA, both from within and without the agency.

Surgeon General’s Ad Hoc Committee on the “Non-Dental Health Effects of Fluoride” (April 1983)

In April of 1983, a Surgeon General committee met for two days (April 18-19) in Washington DC to examine – at the request of EPA – the “non-dental health effects of fluoride.” At the end of the two day hearing, the panel voted overwhelmingly to recommend a federally enforceable water standard (MCL) of 1.4 - 2.4 ppm for children up to the age of 9 – in order to protect children from developing moderate/severe fluorosis. Following the panel’s vote, Dr. Michael Kleerekoper, a bone researcher and panel member, stated:

"We regard dental fluorosis in the Stage III level as an adverse health effect and that is what the regulation has been aimed to prevent. That is really what we have done." (p. 472) See transcript

Another panel member, Dr. Robert Marcus, summarized the panel’s concerns that dental fluorosis could be accompanied by adverse effects on the bone:

"I think it is fairly close to unanimous that we all agreed that dental fluorosis ... has medical ramifications. Almost everybody agreed on that. Not knowing where bone disease begins at any age, what you are saying is that there is something going on in the teeth, then the likelihood is that there is something going on in the bone.” (p. 455-456) See transcript

One month later, in a draft report summarizing their recommendations, panel chairman Dr. Jay Shapiro, wrote:

"While not specifically addressing dental effects there was a consensus 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." See report

EPA’s Director of the Office of Drinking Water (July 1984)

On July 26, 1984, EPA’s Director of the Office of Drinking Water, Victor Kimm, expressed his own concerns about moderate/severe dental fluorosis. According to Kimm:

"It is difficult to conclude a priori that teeth which spontaneously pit are stronger teeth. Further, data suggest that the effects of fluorosis are not merely discoloration and pitting, but fracturing, caries and tooth loss as well... We have some color photos of fluorotic teeth which shows the kind of chipping, pitting and fracturing individuals exposed to high fluoride levels must endure. It is difficult to examine such photos and conclude that such effects are not adverse." See memo

Kimm’s letter was addressed to EPA’s Administrator, William Ruckelshaus, who also believed that moderate/severe fluorosis was an adverse health effect that should be protected against. Acccording to The Progressive:

“Ruckelshaus was shown a set of pictures of dental fluorosis at a high-level meeting in July 1984, recalls drinking water analyst [David] Schnare. Ruckelshaus's comment: "That's an adverse health effect." See article

EPA’s National Drinking Water Advisory Council (August 1984)

On August 2 and 3, 1984, EPA’s National Drinking Water Advisory Council (NDWAC) examined the evidence on fluorosis and “recommended that moderate and severe fluorosis be considered an adverse health effect.” The Council thereby recommended that EPA continue protecting against moderate/severe fluorosis with federally enforceable standards (MCL). See minutes of meeting

The NDWAC made these recommendations based on evidence that moderate/severe fluorosis is “associated with cosmetic deformity, dental dysfunction, and/or social/behavioral effects.”

National Institute of Mental Health committee (October 1984)

On October 31, 1984, a panel of scientists at the National Institute of Mental Health (NIMH) examined pictures of moderate/severe fluorosis to assess whether these conditions could be reasonably anticipated to cause adverse effects on a child’s psychological and emotional development (due to the embarrassment and stigma of having brown, black, and/or pitted teeth). After reviewing the pictures, the NIMH committee informed EPA that:

"It is concluded that individuals who have suffered impaired dental appearance as the result of moderate to severe fluorosis are probably at increased risk for psychological and behavioral problems or difficulties." See excerpt of NIMH report

When EPA received NIMH’s report, staff scientists thought it was the “silver bullet” for retaining the MCLG at 2 ppm, or lowering it to 1 ppm. According to The Progressive:

“EPA staff members were pleased with the results of [NIMH’s] study. "The staff response was: Here is our silver bullet," says Paul Price, then an analyst working on the standard. He recalls that the staff was vacillating between recommending a standard of one ppm or two ppm, to prevent the psychological effects of dental fluorosis.”

EPA’s National Drinking Water Advisory Council (December 1984)

In the wake of NIMH’s report, EPA’s National Drinking Water Advisory Council met again to vote on what the appropriate MCLG should be. The Council members were split on whether to vote for a 1 ppm or 2 ppm standard, with a majority voting for 2 ppm. As reported in the Federal Register (May 14, 1985; p. 20167):

“In its meeting of December 6 and 7, 1984, the NDWAC recommended that the [MCLG] for fluoride be set at 2 mg/L (a minority position – four members of the Council – recommended setting the [MCLG] at 1 mg/L.”

Of note about NDWAC’s recommendations is that, while four of the 11 members voted for a MCLG lower than 2 ppm, not one of the 11 members voted for an MCLG higher than 2 ppm.

The Alteration

Something rather curious happened at EPA between December 1984 and March 1985. Without any new evidence presented on dental fluorosis, EPA Management concluded – in direct contrast to the conclusions of EPA’s staff scientists and Drinking Water Advisory Council – that moderate/severe dental fluorosis is not an adverse health effect, just a “cosmetic effect.”

The significance of this change in definition was huge: By classifying dental fluorosis as a non-health effect, the EPA was no longer required under the Safe Drinking Water Act to issue an MCLG which would prevent it from occurring. Thus, on March 22, 1985, EPA submitted a proposal to the Office of Management and Budget to raise the MCLG to 4 ppm.

How could EPA’s view of dental fluorosis have changed so radically over the course of just 3 months without any new evidence submitted to the agency? The answer may lie in the fact that in January 1985, a new Administration took over at EPA. EPA’s outgoing Administrator, William Ruckelshaus, who believed that moderate/severe fluorosis is an adverse health effect, was replaced by Lee Thomas, a native of South Carolina -- the same state suing to get the teeth out of EPA’s fluoride standards.

Whether or not Thomas’ ties to South Carolina had anything to do with his decision in March 1985 to increase the fluoride MCLG, it seems clear, as reported by The Progressive, that he was “less sympathetic to staff concerns about dental fluorosis.”

As noted by The Progressive:

“Recent interviews confirm that the staff was preparing [in early 1985] to recommend that Thomas issue a one ppm standard. "It is legally and scientifically indefensible to set the [standard] at a level other than optimum (e.g., 1 ppm)," reads the draft of a memo prepared for Thomas's approval.

A handwritten note scribbled on this draft, however, says a higher-level office, controlled not by staff scientists but by political appointees, preferred a binding standard of four ppm, justified by the threat of skeletal fluorosis, another effect of fluoride, but a much less common one. The note added, "And they have the final say!"

The final draft, completed a few weeks later, concluded that dental fluorosis is merely a "cosmetic effect" and recommends a binding standard of four ppm.”

NRDC Takes EPA to Court

EPA’s decision to re-classify dental fluorosis as a non-health effect was met with sharp criticism from the Natural Resources Defense Council (NRDC), which in 1986 took the EPA to Court to challenge the new standard.

In its April 1986 legal brief, NRDC stated:

"To justify raising the permissible exposure to fluoride in drinking water to a level at which the teeth of four out of every ten children will be stained, pitted, and deformed, the Agency now simply states that it no longer regards dental fluorosis as an adverse health effect under the Safe Drinking Water Act. The arbitrary and capricious nature of this radical departure from the Agency's long-standing prior conclusion is underscored by the absence of any stated factual basis for its reversal of position. The Supreme Court has held that a regulatory agency changing its course is obligated to supply a reasoned analysis beyond that which may be required when an agency chooses not to act in the first instance. Here, the Agency examined no relevant data and provided no explanation for its sudden conclusion that this permanently disfiguring condition is no longer included within the SDWA's broad protection against any known or anticipated adverse health effects." See brief

In a later September 1986 brief, NRDC criticized EPA for ignoring the advice of “objective medical panels” and relying instead on “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.”

EPA Headquarters Union Joins NRDC’s Suit Against EPA

In September 1986, scientists at EPA Headquarters Union joined in on NRDC’s suit against the EPA. “What’s remarkable,” noted the Washington Post, “is that the union filed on behalf of the environmentalists, and against the agency.”

Dr. Robert Carton, President of the EPA Union at the time, described in a press release why the Union had sided with the NRDC in the suit. According to 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." See press release

In its legal brief against EPA, the Union detailed how EPA had violated its mandate under the Safe Drinking Water Act to consider health effects which could be “reasonably anticipated,” not just those for which there was absolute proof. The Union argued that ample evidence had been presented to EPA to “reasonably anticipate” that moderate/severe fluorosis would “result in adverse health effects.” However, according to the Union:

“EPA impermissibly applied a conclusive proof standard when confronted with [NIMH’s] 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." 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 [MCLG]. To require conclusive proof in setting an [MCLG] is to disregard the Agency's obligation under the Safe Drinking Water Act. The Act provides that the [MCLG] should be set to protect against "known and anticipated" adverse health effects. 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.” (emphasis in original; see brief)

20 Years Later

Twenty years have now passed since EPA Management reclassified moderate/severe dental fluorosis as a non-health effect. During this time, a number of new studies have been published which have investigated the impact of fluorosis on health. The studies have reinforced NRDC’s and EPA Union’s contention that moderate/severe fluorosis can “reasonably be anticipated to result in adverse health effects.”

The new studies can be divided into 3 categories:

• Fluorosis/Psychological Effects
• Fluorosis/Cavities
• Fluorosis/Bone Fracture

A) Fluorosis/Pyschological Effects

When the National Institute of Mental Health advised EPA in October of 1984 that moderate/severe fluorosis would likely cause adverse effects on a child’s psychological development (due to the chronic embarrassment that would result from having brown/black/pitted teeth), EPA dismissed the concern based on the absence of studies specifically addressing this effect.

EPA would be hard pressed, however, to make this same argument today, particularly in light of a study published in the April 2006 issue of the journal Community Dentistry and Oral Epidemiology.

The study, conducted by a research team at Cardiff University in Wales, investigated the social judgments people make about individuals with severe dental fluorosis. The team found that people with severe fluorosis were consistently judged to be less intelligent, less reliable, less hygienic, less social, and less attractive.

Assuming that any of these unfavorable judgments would impact the child's emotional/psychological development, then severe fluorosis (using EPA's own rationale) would need to be classified as an adverse health effect. As noted by EPA’s Office of General Counsel, dental fluorosis could not be considered as a non-health effect “if it is demonstrated that the ‘cosmetic’ effects lead to adverse psychological effects.” See memo

B) Fluorosis/Cavities

In defining what else, besides psychological effects, would make dental fluorosis a “health effect”, EPA’s Office of General Counsel stated: “if the evidence showing dental caries and cracking of teeth is persuasive.”

It is of note, therefore, that since 1985 at least 8 studies have found that severe fluorosis increases a tooth’s susceptibility to caries (Mann 1987; Chibole 1988; Mann 1990; Cortes 1996; Ibrahim 1997; Nanayakkara 1999; Ekanayake 2002; Wondwossen 2004). Excerpts of these studies can be found online at: http://www.fluoridealert.org/health/teeth/fluorosis/caries.html

The evidence on fluorosis and cavities is now sufficiently “persuasive” that 2 recent reviews, from generally pro-fluoride authors, have conceded that severe fluorosis increases the incidence of cavities, erosion, and tooth fracture (ATSDR 2003; Levy 2003). As noted by Stephen Levy, a prominent dental researcher from University of Iowa:

"With more severe forms of fluorosis, caries risk increases because of pitting and loss of the outer enamel" (Levy 2003).

According to the US Agency of Toxic Substances and Disease Registry (ATSDR):

“In more severely fluorosed teeth, the enamel is pitted and discolored and is prone to fracture and wear” (ATSDR 2003).

Had EPA reached this conclusion in 1985, then – using its own criteria about what constitutes an adverse health effect – it would have had to define severe fluorosis as an adverse health effect. This, in turn, would have necessitated an MCLG no greater than 2 ppm.

C) Fluorosis/Bone Fracture

It has long been suspected that damage to bone development may accompany the damage to tooth development among children with advanced forms of dental fluorosis (Black 1934; Dean 1936; Blue 1938). This suspicion was seconded by the Surgeon General’s Ad Hoc Committee on the “Non Dental Health Effects of Fluoride.” According to the Committee’s Chairman, Dr. Jay Shapiro:

“there was a consensus that mottling or pitting of teeth could represent as yet unknown skeletal effects in children.”

Unfortunately, while the Committee recommended to the EPA that research be done to assess the relationship between dental fluorosis and bone development, no such research in the US has yet to be published. As is often the case, however, research on this issue has been conducted outside the US.

In 2001, a research team from Mexico (Alarcon-Herrera 2001), reported the results of a survey assessing the incidence of bone fractures among children and adults living in a high-fluoride region of the country (1.5-5.5 ppm). The team reported that, among the population surveyed, the rate of bone fracture increased as the severity of dental fluorosis increased.

As noted above, the Safe Drinking Water Act requires EPA to protect against any effect that can be “reasonably anticipated” to occur from exposure to a certain chemical. While one study can not conclusively resolve the question of whether dental fluorosis increases the risk for bone fracture, the Mexican team’s findings – particularly when considering the cortical bone defects found in children drinking fluoridated water (Schlesinger 1956) and the concerns raised by the Surgeon General’s medical committee – raises the question of whether it can be “reasonably anticipated” that advanced dental fluorosis increases the risk for bone damage.

Will the Upcoming NRC Review Intervene?

So, will the NRC’s upcoming review of EPA standards bring the tools of science, and the mandates of the Safe Drinking Water Act, back to the issue of dental fluorosis? Let’s wait and see...