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NRC Countdown Report #1

DIRECTORY: Health > EPA Fluoride Standards > NRC Review > NRC Countdown


Fluoride Action Network
March 13, 2006

NRC Countdown Report #1

by Paul Connett, PhD
Executive Director, FAN

Dear All,

It appears that the National Academies' report (the NRC review) on fluoride is "at the press." Here is a link to pre-order the report: http://fermat.nap.edu/catalog/11571.html

The report is approximately 500 pages and is entitled: Fluoride in Drinking Water: A Scientific Review of EPA's Standards. We anticipate that the report will be released within the next two or three weeks.

As a prelude to this release we will be distributing several bulletins to provide the background to this report - both political and scientific.

First, it is necessary for people who are new to this issue, to know that there are two agencies in the US dealing with fluoride in water: the CDC and the US EPA. Strangely, the FDA has managed to keep out of this issue.

The CDC, on behalf of the US Public Health Service, is a huge promoter of ADDING fluoride to the water at approximately 1 ppm, ostensibly to fight tooth decay. They are so zealous in the promotion of this policy that they even actively support mandatory fluoridation on a statewide basis. This campaign is directed by the Division of Oral Health at the CDC. As far as watch-dogging health effects are concerned, this agency has a huge conflict of interest. To find a health problem is to pass a judgment against their own long term commitment to promoting this practice.

The US EPA has the job of determining what level of fluoride in water is safe to drink. In other words they treat fluoride as a contaminant. Their mandate is to determine at what level natural fluoride has to be REMOVED. That level was raised from 2 ppm to 4 ppm in 1985. This was greeted with huge consternation by scientists at the US EPA, who believed - and documented - that political pressures had been brought to bear on administrators to do this. We will discuss this documentation in a future bulletin.

The NRC reviewed this 4 ppm standard in 1993 but the review panel was stacked in favor of those supporting fluoridation. The chairman was a consultant for the tobacco industry for over six years. The report contained several errors and the executive summary gives a far more sanguine view of the health issues than the detailed chapters. Huge areas like fluoride's impacts on the brain were not considered. The report recommended further research on bone fractures and cancer, but little of this research has been carried out or published.

Panel not to consider "benefits"

The current panel has been specifically told that they are not to get involved with considerations of the "benefits" of fluoridation. This is very important because it should remove any notion of tempering their recommendations in order to "protect the fluoridation program."

MCLG or MCL?

Although the water is somewhat muddied because the MCL and the MCLG are both set at 4 ppm, the panel should not be concerning themselves with the MCL (maximum contaminant level), but rather only the MCLG (maximum contaminant level goal).

This is important. The MCLG is the ideal goal one would want in order to protect everyone in society - including the most vulnerable (e.g. infants, the elderly, the sick, those with nutritional deficiencies - e.g. iodine - and those with impaired kidney function) from fluoride's toxic effects. This goal may be neither practical nor achievable, however it is still the task of the NRC panel to come up with their best recommendation for this.

A key step in determining this MCLG will be selecting an appropriate margin of safety, which will protect the most vulnerable members of society, as listed above.

The MCL - a legally enforceable standard - should be left to the US EPA. This standard is a compromise between the MCLG (determined with the best scientific judgment) and the economic costs of removing natural fluoride down to the chosen level. A good illustration of the difference between the MCLG and the MCL is provided by the case of arsenic. The MCLG for arsenic is set at zero, because arsenic is a known human carcinogen. However, the MCL for arsenic is 10 ppb, because of the costs of removing natural arsenic down to this level. Even setting the MCL at this level caused objections among certain western states - because of the costs incurred.

How was the MCLG of 4 ppm derived?

There are three steps in the EPA's 1985 determination.

1) They considered that it would take 20 milligrams of fluoride per day to increase someone's lifetime risk of contracting crippling skeletal fluorosis (the only end point the EPA considered).

2) They applied a safety margin to this of 2.5 ostensibly to protect all the members of the human population, including the subsets listed above. 20 milligrams per day divided by 2.5 gives a safe daily dose (for everyone) of 8 milligrams per day.

3) They then assumed that people drank a maximum of two liters of water per day, which means that it is safe for everyone to drink water at 4 milligrams per liter (i.e. 4 ppm). Two liters per day at 4 milligrams per liter would give one a dose of 8 milligrams per day.

Five questions

This derivation poses five questions. They are:

1) Is crippling skeletal fluorosis the most sensitive end point of fluoride's toxic effects on bone and is bone the most sensitive tissue to fluoride?

2) Will no damage occur to bone (or other tissues) at doses less than 20 milligrams per day?

3) Is a safety margin of 2.5 adequate to protect the whole range of sensitivity (again consider the subsets listed above) we can expect in a human population to any toxic substance?

4) Is water the only source of fluoride, and if it is not, should not an adjustment be made to the 8 milligrams per day figure before moving on to a safe level in water?

5) Is two liters of water the maximum amount of water drunk by any American?

FAN's answers to these five questions

We have no way of knowing what answers the panel will give to these five questions, however we have submitted our own critique of EPA's methodology both to the NRC and to the pesticide division of the EPA (the latter is using the 4 ppm MCLG in its health risk assessment of Dow Agrosciences' request to use sulfuryl fluoride as a fumigant on foods). Here then are FAN's answers:

1) Not only is bone not the most sensitive tissue to fluoride but crippling skeletal fluorosis is not the first toxic effect on bone.

2) Even if one accepts crippling skeletal fluorosis as the most sensitive end point, even the NRC 1993 review acknowledged that 10 milligrams per day (not 20 milligrams per day) could lead to this condition.

3) By no stretch of the imagination could any honest toxicologist sanction the use of a safety margin of 2.5 to protect all the subsets in a human population. A safety margin of at least 10 would be required, and even higher if we wanted to introduce an extra safety margin for infants and young children whose developing tissues are known to be more sensitive to toxic substances.

4) The EPA was wrong not to subtract from the 8 milligram per day figure, the daily fluoride intake from other sources such as dental products, pesticide residues, food and beverages made with fluoridated water, some foods naturally high in fluoride (e.g. sardines and tea) and certain types of fluorinated pharmaceuticals.

5) The EPA was clearly wrong - based even on their own publications - with the assumption that people only drink 2 liters of water per day. Some people drink as much as 5 liters a day or even higher. The Institute of Medicine even recommends that adults drink three liters of water per day.

If all the appropriate adjustments are made, the MCLG would have to be lowered to 0.4 ppm at most.

In addition to these very basic calculations, there is another route which could lead to the panel recommending a drastically lowered MCLG. This would be the panel's judgment on the new evidence pertaining to osteosarcoma and fluoride exposure. If the panel concludes that the weight of evidence of animal and human studies now points to a likely relationship between young boys drinking water at 1 ppm, or less, during their 6th, 7th and 8th years, and an increased risk of osteosarcoma, a rare and frequently fatal bone cancer, they would have to recommend an MCLG of zero.

Thus, we have to wait and see how they handle the Bassin thesis and, of course, the Douglass (Bassin's thesis adviser) cover-up. FAN provided the relevant chapter of Bassin's thesis to the panel, and one of the panel members went to Harvard University to read the whole thesis. Prior to this, Douglass had submitted to the panel the same report he had sent to his NIH funders, in which he claimed that he had found no relationship between fluoridated water and osteosarcoma, and even cited Bassin's thesis as a reference to support that conclusion - even though it totally contradicted his claims.

We now know that Bassin stands by her findings and that her work has been accepted for publication. Douglass has claimed that a future report that he would co-author with Hoover and Whitford would vindicate his "position" - however, this has yet to materialize. So what will the panel make of all this?

As the report is 500 pages long we can expect some very detailed analysis of the literature which has emerged since the 1993 NRC review. However, it would be tragic if a detailed analysis of the literature was used to duck a strong recommendation to the US EPA on the MCLG. Nor will it be helpful if the panel uses the inevitable uncertainties - which always exist in epidemiological studies - merely to recommend "further studies." The fact that those governments around the world who practice and promote water fluoridation have failed miserably to fund studies which seriously investigate the connection between fluoridation and many potential and serious end points, should not be used to shield this practice any longer. This is especially so since very few American studies have resulted from the recommendations from the 1993 NRC panel.

We strongly believe that the panel has been provided with enough scientific information to conclude that, while it might be difficult for the EPA to come up with an MCL, above which money should be spent to REMOVE natural fluoride, that they have seen enough to recommend an MCLG that would mean that this toxic substance not be deliberately ADDED to the drinking water.

Hopefully, the stage will be set for focusing our future attention with grappling with the problems of over-exposure to natural fluoride and not artificial fluoride.

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