FLUORIDE CLASS ACTION

JAMES ROBERT DEAL ATTORNEY PLLC
PO Box 2276, Lynnwood, Washington  98036-2276
Telephone 425-771-1110, Fax 425-776-8081
James@JamesRobertDeal.com

What or Who Is The National Sanitation Foundation?
by James Robert Deal, President, Fluoride Class Action
www.Fluoride-Class-Action.com/Sham
January 9, 2012

 

Summary: This is the story of how an obscure trade association, formed in 1944 to make standards for restaurant sanitation chemicals, grew to the point where today it has agency-like authority to approve fluoridation materials and other chemicals as safe to drink[1].

 

I refer to the National Sanitation Foundation, more commonly known as “NSF”. The EPA delegated authority to NSF[2] to approve fluoridation materials[3] and other additives to drinking water. NSF says on its website:

 

In 1988, the U.S. Environmental Protection Agency (EPA) replaced its own drinking water additives program with NSF/ANSI Standards 60 and 61, which set public health standards for all chemicals used to treat water and products coming into contact with drinking water[4] ….

 

Starting in 1985 the EPA sent its experts to NSF to help them get up and running as a fluoridation approving agency. From the beginning EPA gave NSF money. EPA still gives NSF money[5] to support NSF’s fluoride approval program.

 

The EPA had no authority in 1985 to approve fluoridation nor to assign authority to NSF to approve fluoridation. Today the EPA has no authority to fund or encourage NSF to approve adding a drug – in this case a toxic one – to drinking water, but it continues to do so. EPA still reviews and approves NSF standards regarding fluoridation materials[6].

 

Chemical companies have waste silicofluoride to sell, so they apply to NSF for NSF 60 certification of their product. The approval process[7] is easy. The product is tested only occasionally. Individual batches do not have to be tested. A company might go for years without having one of its batches tested, as discussed below.

 

Silicofluoride comes from the smokestacks of phosphate fertilizer companies. The raw phosphate rock is rich in heavy metals and around 4% fluoride. The heavy metals and the fluoride formerly went up the smokestacks, but thanks to clean air pollution laws it started coming out in the wet scrubbers installed in the smoke stacks. What was to be done with the scrubber liquor? The solution was dilution. Without any further filtration or processing, scrubber liquor is moved into truck or rail tankers and shipped to Everett and Seattle where it is piped into our drinking water. The air pollution problem was solved but a water pollution problem was created.

 

The best way to deal with the waste would be not to create it in the first place. Organic farmers do not use super-phosphate fertilizer on their fields. There are better ways to feed phosphorus to farmland[8].

 

It is illegal to pollute the air with fluoride and to dump the fluoride scrubber liquor into river, lake, or ocean, but it is dumped indirectly into rivers, lakes, and oceans via our drinking water. According to Dr. Richard Sauerheber[9], the least harmful way of disposing of raw scrubber liquor would be to dump it into the open ocean, where there is enough calcium, magnesium, and other positively charged ions to neutralize the acid. The best solution would be not to produce the scrubber liquor in the first place.

 

Some 47 states and nine Canadian provinces[10] by law recognize the NSF Standard 60 stamp of approval as authoritative. These states and provinces allow fluoridation only with fluoridation materials which meet NSF 60 standards, as does Washington[11].

 

The states and provinces may regard NSF 60 so highly because the EPA says it “approve[s the NSF 60 standard] for publication”, provides “partial funding … for the development and implementation of NSF Standard 60”, and because there was “participation of US EPA representatives in the standards development or implementation activities”. Read excerpts from NSF Standard 60 here[12].

 

NSF Standard 60 and the NSF web site state repeatedly that toxicological and health studies are required, as I will detail below. However, NSF representatives have admitted that NSF does not obtain toxicological studies on fluoridation materials from the fertilizer company suppliers nor does it do its own toxicological studies on fluoridation materials – despite the fact that NSF has its own toxicologists on staff[13] and runs its own toxicological department.[14]

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Some 200 million of us, some 70% of the residents of the United States, drink fluoridated water. When tap water is fluoridated, everything made with tap water is fluoridated. So we drink fluoridated beverages and eat fluoridated food. Our bread, our restaurant food, our beer, our deserts, and our reconstituted juices are fluoridated.

 

Commercial dried eggs are used to make hundreds of foods, and around a third of all eggs are turned into dried eggs. It is legal for dried eggs to contain up to 900 ppm fluoride. How does the fluoride get there? The grains which chickens eat are fumigated with sulfuryl fluoride to kill weevils. But the predominant factor is that it is still legal to apply sulfuryl fluoride to finished dried eggs – again to kill weevils – although this practice is being phased out.

 

There are other ways fluoride gets into chickens and their eggs. Chickens – and other meat animals – are fed phosphate fertilizer rich in fluoride. Bones are high in fluoride because fluoride seeks out calcium. Bones are mechanically cleaned, and the knives scrape off much of the bone and mix it into generic meat, some of which is fed back to chickens and other animals, or into your hamburger, hot dog, sausage, or chicken nugget, all of shich may contain bone fragments, and therefore will be high in fluoride.

 

We shower and bathe in fluoridated water. We wear clothes washed in fluoridated water, and this bathes our skin in fluoride as we perspire during the day. We water our gardens with fluoridated water.

 

We also ingest fluoride through toothpaste even if we spit most of it out. We only need to swallow a little toothpaste, at 1,500 to 2,400 ppm, to get a whopping dose of fluoride. As we brush we absorb fluoride through your tongue and gums and the soft tissues in our mouths.

 

Toothpaste tastes good, so many children lock themselves in the bathroom and eat it. Many have gorged on it and made themselves sick and become hypersensitive this way. If you have young children, it is dangerous to keep fluoridated toothpaste in the bathroom or any place where a child can get to it.

 

Despite our pervasive exposure to fluoride, there is no federal agency which has ever tested the fluoride which we add to our drinking water;  nor has any federal agency approved it to be safe. We continue to drink it because respected pro-fluoride dentists and doctors reassure us that it betters our teeth and does us no harm. The doctors and dentists reassure us because they are reassured by their medical and dental schools, which receive large donations from chemical and toothpaste companies. Our water district board members accept it because they are reassured by a sham-agency known as NSF. Most of us accept it because we are trusting of authority figures.

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For drinking water fluoridation we use two classes of fluoride, sodium fluoride (NaF) and silicofluoride (SiF). Sodium fluoride comes in dry form, in crystals like table salt.

 

Silicofluoride comes in dry and liquid forms. I use the term “silicofluoride” or “SiF” to refer to both, although some say “silicofluorides”. Sodium hexafluorosilicate is the dry form, and it looks like table salt. The more common form is the liquid fluorosilicic acid, aka fluosilicic acid or hydrofluorosilicic acid, and it comes to Everett and Seattle in 5,000 gallon truck tankers. Everett buys a tanker load every three weeks, around 18 tanker loads per year and spends around $290,000 per year[15] for silicofluoride, a complete waste of money. Everett’s 20 year old fluoridation equipment is worn out and will be replaced in February, another waste of money.

 

Fluoridation started in 1945 in Grand Rapids, Newburg, and Brantford. Sodium fluoride was used. Fluoridation became a big hit very quickly. There was not enough sodium fluoride to go around. So industry switched to the cheaper, toxic waste, industrial, fertilizer company waste product version of fluoride – silicofluoride.

 

The original supply of sodium fluoride came from aluminum companies, including ALCOA. It was industrial grade NaF and not pharmaceutical grade, but it was less contaminated with heavy metals than silicofluoride.

 

Today around 8% of fluoridation is still done with sodium fluoride and around 92% with silicofluoride. Some favor going back to using sodium fluoride because they have heard that it is less contaminated. It probably was less contaminated back in the 1950s when sodium fluoride came predominantly from ALCOA and the other aluminum companies, however, that has changed. Today some sodium fluoride is produced out of silicofluoride, meaning that it can contain the same lead, arsenic, and other contaminants as does silicofluoride.

 

Most naturally occurring fluoride is in the form of fluorite or calcium fluoride (CaF_2).  Calcium fluoride can be used for fluoridation, and it was used by some water districts when fluoridation first began. It is still used by some cities in Costa Rica. Calcium fluoride is not as immediately poisonous as silicofluoride or sodium fluoride because it comes with its own calcium. Calcium fluoride is not sold because it costs more, is in short supply, is more pure, and because it has other uses. It is not a product that the chemical companies need to unload. With silicofluoride on the other hand, there is a surplus.

 

There is a strong case that neither the teeth nor any other part of the body needs any fluoride of any kind or in any amount whatsoever. All forms of fluoride are eventually harmful to all of us. Some of us are more vulnerable and are harmed more quickly. And there are better ways of preventing tooth decay[16] than by applying or eating a rodenticide.

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This is not just an academic, theoretical, constitutional debate about who controls what goes into our bodies or whether a helpful medication should be delivered to all via public water systems. Fluoridation materials are harmful to health. There is a constitutional issue. But there is also a common law assault and battery going on, and it is the babies who are hit hardest.

 

Silicofluoride contains lead.[17] The EPA maximum contaminant level (MCL) for lead is 15 ppb, and the maximum contaminant level goal (MCLG) is zero. Lead permeates all cells in the body[18], reduces IQ, and causes kidney disease and high blood pressure. In 2004 Seattle papers reported lead at up to 1,600 ppb (1.6 ppm, an extremely high level) found in drinking water in old Seattle schools. Silicofluoride, more so than sodium fluoride, leaches lead[19] out of pipes and brass fittings. Seattle schools are busily replacing old pipes at great cost. If Seattle would end fluoridation, there would be less need to replace pipes.

 

Further, even if Seattle solves the lead problem in its old schools, it will not be solving the lead problem overall. There will still be lead bearing pipes in old homes, old apartment buildings, old commercial buildings, and so on. Any structure built before 1986 may contain pipes with 30% lead in them. Even in new homes the lead level in brass fittings on your sink are typically 8% lead, so the problem is pervasive.

Silicofluoride contains arsenic[20], a confirmed Type 1, Class A human carcinogen[21]. For arsenic the MCL is 10 ppb and the MCLG is zero. A zero MCLG for lead and arsenic means that there is no level of lead or arsenic which can safely be added to drinking water. Silicofluoride and sodium fluoride[22] are carcinogens[23], mutagens[24], and poisons[25]. They denature protein. They are enzyme interrupters. They are anticholinesterase inhibitors[26].

A “Review of the Toxicological Literature on Sodium Hexafluorosilicic Acid and Fluorosilicic Acid”[27] presented to the National Institute of Environmental Health Sciences in 2001 made it clear that the silicofluoride delivered to Everett and Seattle contains radionuclides:

Radium wastes come from the filtration systems. Uranium and its decay-rate products are found in the phosphate rock and fertilizer as well as the byproduct fluorosilicic acid. During the wet-process procedure, trace amounts of both radium and uranium are captured in the scrubbers and therefore are in the fluorosilicic acid. During the acidulation process yielding phosphoric acid, radon gas in the phosphate pebbles can be released and carried into the fluorosilicic acid, while polonium can be captured during the scrubbing process and then can combine with fluoride (Glasser, undated).

In the manufacture of phosphate fertilizer in Central Florida, fluorides and radionuclides (radium and uranium) are released as toxic pollutants. During the acidulation process, radon gas can be released and carried into the fluorosilicic acid, while polonium can be captured during the scrubbing process and combined with fluoride.

An x-ray in the dental office is brief; the radioactive mater stays outside the body and is a fair distance from the body. When one drinks uranium, radium, polonium, and thallium, some radioactive matter will lodge within the body where it will continuously emit rays at close proximity. Radioactive materials are carcinogenic.

Kidneys at best only excrete half the fluoride[28] we consume. The effect is cumulative. Babies are highly sensitive to lead, arsenic, and fluoride because their cells are still dividing and because they drink so much fluids relative to their body weight. Their kidneys are not mature[29] and excrete only around 20% of fluoride consumed, while a healthy adult can excrete around 50%. The rest is stored permanently in bones and other calcium rich tissues. CDC, ADA, AMA, the surgeon general, and others have advised that if formula is mixed using fluoridated water that it will cause dental fluorosis[30]. But the poor cannot afford to buy and haul fluoride-free water home or buy and maintain an expensive filter.

Fluoride is added allegedly to reduce caries, however, documents posted on the CDC website claim only an 18-25% reduction[31] in caries. Other credible studies show no reduction. Tooth decay has dropped just as much in non-fluoridated Europe[32] as in fluoridated United States, so fluoridation cannot be the causal factor.

Documents posted on the CDC website admit that the effect of fluoride on teeth is topical[33] and not systemic, but strangely, CDC still endorses drinking fluoride. Other documents on the CDC website admit that 41% of children 12 – 15 years old have fluorosis[34], while  8.6% suffer from moderate fluorosis (white spots and some brown spots with up to 50% of enamel impacted), and 3.6% suffer from moderate and severe fluorosis (white spots and brown spots and sometimes pitting and chalky teeth and 100% of enamel impacted). Fluorosis can be ugly[35]. Fluorosis should not be forced on people just so tooth decay can allegedly be reduced and then only slightly. The way to cut tooth decay is to quit eating and drinking sugary and fatty junk foods and instead to eat vegetables rich in minerals.

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If you have heard a tune sung a certain way all your life, there is dissonance when you hear it sung a different way. We tend to be creatures of habit and to distrust things that seem different. We have been propagandized heavily to believe that fluoridation is good for us and will do us no harm. So when critics of fluoridation come forward, it is to be expected that they will be viewed as heretics and conspiracy theorists. People wonder how fluoridation – if it is so harmful – could have arisen and why – if it is so harmful – it continues. So I will now tell the tale of how it came to be that we would add dilute poisons to our drinking water.

 

In 1901 Dr. Frederick Sumner McKay, dentist, wrote observations in his journal about the white and brown stains he saw on the teeth of his patients in Evergreen, Colorado, near Colorado Springs.

 

But it wasn’t until 1931, after McKay enlisted the help of chemists for the American Aluminum Company (ALCOA) at an Alum mine in Bauxite, Arkansas, that they found an interesting similarity shared by water samples from every region that had chronic tooth staining. They all had high levels of fluoride.

 

The discovery led McKay to rename the condition “fluorosis,” a condition that still affects many children growing up in Colorado Springs and many other cities around the world where children are exposed to high levels of naturally occurring fluoride.

 

McKay and others also made another important observation about the patients afflicted with Colorado Brown Stain: they had fewer cavities than most. Colorado Springs Independent, May 11, 2000[36].

 

Bear in mind that the fluoride in Colorado Springs was naturally occurring calcium fluoride. It is less harmful than the manmade fluorides because it comes with its own calcium, and it often occurs in water which is high in calcium, magnesium, and other minerals. According to Dr. Richard Sauerheber[37], it is not fluoride per se we should worry about so much as the ratio between fluoride and positively ionic minerals such as calcium and magnesium. Some hard water drinking wells can contain 200 ppm calcium. Dr. Sauerheber speculates that it was not the fluoride which prevented tooth decay in Colorado but the high mineral levels.

 

Maybe it was when ALCOA profiteers met Dr. McKay and heard that children with fluorosis allegedly had fewer caries that two malignant ideas came together: the idea that fluoride could help teeth and the idea that chemical companies could use their waste fluoride to fit that alleged need. Companies such as ALCOA had excess sodium fluoride to sell[38].

 

From the beginning ALCOA was at the center of efforts to get people to drink artificial fluoride added to drinking water. ALCOA turned toxic waste sodium fluoride into a profit center. As they say in the Bronx, they turned shit into shinola. Note that no effort was made to market naturally occurring calcium fluoride, which could have been mined. ALCOA wanted to sell the type of fluoride it had in excess, the cheaper sodium fluoride.

 

Quoting from Fluoride Alert on How Industry Influenced EPA’s Fluoride Safety Standards[39]:

 

Gerald Cox was an ALCOA-funded scientist at the Mellon Institute in Pittsburgh. In 1939, after scientists from the American Water Works Association had recommended a Maximum Contaminant Level for fluoride of 0.1 ppm (to prevent dental fluorosis), Cox argued that “The present trend towards complete removal of fluoride may need some reversal”.[40] Cox made the suggestion based on his own animal studies (funded by ALCOA) which suggested that rats given fluoride had stronger teeth.

 

This interwar period saw the birth of the military-industrial complex,[41] with its concomitant public disinformation campaigns. It also saw a federal blitz campaign to convince the public fluoride was safe and good for them. The kick-off was previously quoted  Cox declaration.

New evidence of fluoride’s safety began emerging from research centers plied with industry’s largess. Notable among these was the University of Cincinnati’s Kettering Laboratory,[42] whose specialty was investigating the hazards of industrial chemicals. Funded largely by top fluoride-emitters such as ALCOA, the Kettering Lab quickly dominated fluoride safety research. A book by Kettering scientist and Reynolds Metals consultant E.J. Largent, for example, written in part to “aid industry in lawsuits arising from fluoride damage,” became a basic international reference work.[43]

The big news in Cox’s announcement was that this “apparently worthless by-product” had not only been proved safe (in low doses), but actually beneficial: it might reduce cavities in children. A proposal was in the air to add fluoride to the entire nation’s drinking water. While the dose to each individual would be low, “fluoridation” on a national scale would require the annual addition of hundreds of thousands of tons of fluoride to the country’s drinking water.[44]

 

ALCOA hired Robert Kehoe, a rising star chemist with the Kettering Institute[45] to give fluoride a shiny new patina. ALCOA was the first company to sell fluoride as a water additive.[46]

 

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Before the Kettering Institute promoted fluoridation, it promoted tetraethyl lead.[47] I will now digress and give you an overview of the tetraethyl lead story. I do so because it is so similar to the fluoridation story and because the same people were involved at the inception of each. In both cases chemical companies lied and continue to lie to increase profits.

In the 1920s ethyl alcohol was being mixed with gasoline. Today we call it ethanol. Ethanol did a very good job of keeping gasoline engines from knocking or pinging.

Then chemists discovered tetraethyl lead. Ethanol had an enemy.

Tetraethyl lead did have some minor advantages. It works well in high compression piston engines. It is still used in some piston aircraft.

Unfortunately, tetraethyl lead was also very poisonous. On the other hand, there was more money to be made with tetraethyl lead than with ethanol. Ethanol could not be patented, but a blend of tetraethyl lead with gasoline could. So captains of industry manipulated government to allow its use.[48]

The same Robert Kehoe of the same Kettering Laboratories promoted both tetraethyl lead and fluoride.

Ethyl brand leaded gasoline — tetra-ethyl lead … [was] one of the world’s greatest environmental disasters. [W]hole nations were poisoned. General Motors, Standard Oil and the Ethyl Corp. claimed there were no alternatives …. But there were alternatives. … Three grams of tetra ethyl lead [or] 15 percent ethyl alcohol [CH₃–CH₂–OH] both improved a fuel’s power [equally well]. [Tetraethyl lead] was cheap, but it was a well known poison. … Just after World War I, American engineers made their choice [for tetraethyl lead]. Putting profit above public health was nothing new for American industry, but it had never been done on such a massive scale and with such deadly results…”[49]

Leaded gasoline created enormous profits … at the expense of the health of the many. The [story] shows what can happen when the precautionary principle is ignored. …”[50]

From around 1923 until tetraethyl lead was phased out starting in 1973, everyone in congested streets was poisoned[51] by tetraethyl lead.[52]  Leaded gasoline is the only gasoline sold in Burma and Afghanistan. It is also sold in Algeria, Iraq, North Korea, and Yemen.

The point of this diversion into the story of tetraethyl lead is to show that big chemical companies will lie to maximize profits, and thus to open your mind to the possibility that you are being lied to about fluoride the way your grandparents  were lied to about tetraethyl lead.

My point is that we should quit being naïve. Big companies will lie to us to maximize profits. They will poison their own children to maximize profits. Big companies will contribute heavily to medical and dental schools to get “their people” appointed to critical positions from which new doctors and new dentists will be graduated out who consider fluoridation a virtuous cause. They will contribute heavily to congressmen to get them to appoint “their people” to critical positions in agencies such as FDA, EPA, and CDC. Private employees get huge bonuses before moving to working for a government agency, and they get huge bonuses when they return to corporate employment[53]. Agencies end up being captured by the industries they regulate.

In this way state governments and local water districts across the country have been scammed and defrauded into buying and injecting fluoride into drinking water.[54]

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ALCOA had an ally, the Public Health Service,[55] at that time a branch of the military.[56] When drinking water fluoridation began in 1945, it was pushed by the Public Health Service.[57]

 

The Atomic Energy Commission and the Manhattan Project[58] were also strong promoters. They wanted to know more about fluoride and – perversely – favored testing it on people. Their cynical interest was twofold: First, they wanted to know how ingestion of fluoride would affect workers. Would it make them less efficient or impair their ability to concentrate? Second, they wanted data so they could defend against the rising flood of suits for fluoride poisoning. The contribution of the Manhattan Project was to recruit dentists to spread the fluoride gospel very early on. (Christopher Bryson, The Fluoride Deception, p. 78 ff.)

 

Uranium and aluminum companies especially were being sued. They used fluoride to produce their products, belched out fluoride fumes that formed a downwind toxic cloud, and had waste fluoride left over. Farmers sued for damage to everything from peaches to cattle. The Atomic Energy Commission wanted human experimentation done to determine just how harmful fluoride was. A 1948 report on the Newburg study showed fluoride was harmful, but those sections which indicated that fluoride was harmful were deleted from the published version by the Atomic Energy Commission allegedly for national security reasons.[59]

 

Fluoride dissolves uranium and forms uranium hexafluoride, so it was and remains crucial in separating the different uranium isotopes. Fluoride is also important in production of steel, aluminum, computer chips, and concrete. Fluoride causes metal to “flow”, hence the origin of its name. Mixed with metals it lowers melting point. Without fluoride it would be impossible to “crack” petroleum and produce gasoline.

 

The chemical companies organized the “Fluorine Lawyers”, a platoon of defense attorneys who were ready at a moment’s notice to pounce on all who dared file a claim against the government or private industry for harm caused by “fluorine”. The Fluorine Lawyers were highly experienced. They had their expert witnesses lined up. They had pocket briefs at the ready on every possible issue which might arise. They pounded local, inexperienced attorneys with motions and depositions. They ran up the costs and fees and overwhelmed plaintiffs and their attorneys, who were forced to settle for nominal amounts.

 

One would expect that before implementing fluoride testing on humans the Public Health Service would have gone to the FDA for approval, but no approval was obtained from the FDA or any other agency. The military backed fluoridation along with the Public Health Service, then a part of the military, and so fluoridation was pushed through without approval as to its safety or effectiveness.

 

Bear in mind that this was going on during and immediately after World War II, at a time when the military could do pretty much anything – in the name of defeating the Germans, Japanese, and then the USSR. The Manhattan Project also administered plutonium[60] to unknowing human subjects to see just how deadly it was.

 

The FDA, in existence under that name since 1938, would have been the logical agency for the Public Health Service to go to for approval of fluoride in public water for human consumption, given that fluoride met the definition of a drug,[61] that is:

 

articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and … articles (other than food) intended to affect the structure or any function of the body of man or other animals.

 

Roots of the FDA go back to the late 19^th Century, but it was the Pure Food and Drug Act passed in 1906 that is regarded as the true beginning of the FDA. Passage of the Food, Drug, and Cosmetic Act in 1938 broadened FDA powers[62].

 

By the early 1950s, fluoridation was declared a success, before comparative studies had been completed. Results which called fluoride safety into question were ignored[63] or suppressed.[64] Fluoridation expanded quickly, without any approval of the fluoridation materials by the FDA or any other agency. The best explanation for the reckless implementation of fluoridation is that the military was doing it, and so it was in a sense “bullied in” and over time “grandfathered in”.

 

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The FDA was a relatively new agency at that point. Perhaps it was intimidated by the military and the Public Health Service and for such reasons failed to ban fluoridation.

 

The Durham-Humphrey Amendment of 1951[65] (65 Stat. 648) for the first time explicitly defined two classes of medications (prescription and over-the-counter, OTC.[66] I speculate that this new law gave the FDA a backdoor way to approve fluoridation or at least avoid condemning it, that is by approving it not as a prescription drug but as an OTC drug. The FDA adopted the following regulation in 1952:[67]

 

(a)      The program for fluoridation of public water supplies recommended by the Federal Security Agency, through the Public Health Service, contemplates the controlled addition of fluorine at a level optimum for the prevention of dental caries.

(b)      Public water supplies do not ordinarily come under the provisions of the Federal Food, Drug, and Cosmetic Act. …

(c)      The Federal Security Agency will regard water supplies containing fluorine, within the limitations recommended by the Public Health Service, as not actionable under the Federal Food, Drug, and Cosmetic Act. Former 21 CFR 3.27 (1952); 17 FR 6732[68].

 

Note that this regulation strongly suggests that the FDA passed it due to pressure from the Public Health Service and the Federal Security Agency.

 

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The Food, Drug, and Cosmetics Act (FDCA) defines a drug as

 

articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and … articles (other than food) intended to affect the structure or any function of the body of man or other animals. 21 USC 321 (g)(1)(B).[69]

 

Note the emphasis on “intended use”. The issue is not whether the drug actually cures or prevents harm. The issue is whether the drug claims to do these things.

 

Because fluoridated water meets the definition of a drug, the US Food and Drug Administration (FDA) should have asserted its jurisdiction over fluoride added to drinking water. Dental caries is a disease, and fluoride is added to water to prevent caries.

 

However, the FDA chose to back down to the Public Health Service, to classify fluoridation as “not actionable[70]”, and not to assert jurisdiction over fluoride scrubber liquor in its raw state nor over the fluoride-tap water medication mixture called fluoridated water.

 

The FDA has asserted jurisdiction over toothpaste and mouthwash, which are not to be swallowed, and has asserted limited jurisdiction over fluoridated bottled water.[71] Fluoridated bottled water is a bad thing, but not nearly as bad as fluoridated tap water. One can avoid fluoridated bottled water by not buying it. One can avoid exposure to fluoride in tap water only by going to great exposure.

 

However, although the FDA by law has jurisdiction over the fluoride tap water drug, it has not exercised that jurisdiction, although it appears to be positioning itself to do so.

 

Congress amended the 1938 FFDCA in 1962 to change the standards for applying for and obtaining a NDA (New Drug Approval) or ANDA (Abbreviated New Drug Approval). The standard had been “safe” but was changed to “safe and effective” for intended use.[72] For drugs with approved NDAs under the 1938 Act to retain their NDAs, producers were required to demonstrate they were effective.[73]

 

In 1972 the FDA established a new approval process for nonprescription drugs. 21 CFR Part 330.[74] This process resulted in the establishment of over-the-counter (“OTC”) monographs for various drug classifications of drugs including a monograph for anticaries drug products that do not require a prescription. 21 CFR Part 355.[75] In 1995 the OTC rule was finalized and applied strictly to anticaries drugs, as discussed below.

 

The SDWA was passed in 1974 and amended in 1986. One of its provisions, 42 USC 300g-1(b)(11), apparently part of the original 1974 version of the law, specifically forbids the EPA from enacting any national primary drinking water regulation which would require

 

the addition to drinking water of any substance for preventive health care purposes unrelated to contamination of drinking water.

 

On its face it appears that the purpose of this section of the SDWA is to forbid adding medicines to drinking water. Unfortunately, this law is badly worded. It does not forbid adding drugs to drinking water. It only forbids enacting a national regulation which would require adding them. As long as EPA only recommends adding fluoride and leaves it up to the water districts to require it, the EPA has a wide latitude to implement fluoridation. I contend that EPA, CDC, NSF, and the fluoride producers and resellers, all acting together, have implemented a de facto national drinking water regulation which requires fluoridation now in 70% of the country and that they are jointly violating the Safe Drinking Water Act.

 

The Safe Drinking Water Act set up a federal system, where EPA delegated to the states the authority to enforce the Act. The state standards could be more but not less strict than EPA’s standards. The EPA set maximum contaminant levels (MCLs) for elements and compounds. The MCL for fluoride is 4 ppm. The MCL is the action level. When the level of a chemical is above the MCL, action must be taken to remove it. The MCLs were not authorizations to add elements or compounds up to the MCL limit but to remove contaminants if they were higher than the MCL level. I will discuss this in more in detail below.

 

An MCL should be set as closely as possible to the MCLG, taking technology and costs into account. 42 USC 300(g)[76] says:

 

[E]ach national primary drinking water regulation for a contaminant for which a maximum contaminant level goal is established under this subsection shall specify a maximum contaminant level for such contaminant which is as close to the maximum contaminant level goal as is feasible. … [T]he term “feasible” means feasible with the use of the best technology, treatment techniques and other means which the Administrator finds, after examination for efficacy under field conditions and not solely under laboratory conditions, are available (taking cost into consideration).

 

There is also a maximum contaminant level goal (MCLG) An MCLG is a non-enforceable goal derived solely from health effects data. The EPA says that the MCLG is “the level of a contaminant in drinking water below which there is no known or expected risk to health. MCLGs allow for a margin of safety and are non-enforceable public health goals”.[77] 42 USC 300(g)[78] says:

 

Each maximum contaminant level goal established under this subsection shall be set at the level at which no known or anticipated adverse effects on the health of persons occur and which allows an adequate margin of safety.

 

An MCL should be set as closely as possible to the MCLG, taking technology and costs into account. However, in the case of fluoride the MCLG is the same 4 ppm as the MCL, which is absurd because the EPA admits that 41% of children 12-15 are developing dental fluorosis at the 1.0 ppm level. The goal should be zero, just like for arsenic and lead.

 

The EPA has established a secondary MCL[79] for fluoride to protect against fluorosis:

 

EPA has also set a secondary standard (SMCL) for fluoride at 2.0 mg/L or 2.0 ppm. Secondary standards are non-enforceable guidelines regulating contaminants that may cause cosmetic effects (such as skin or tooth discoloration) or aesthetic effects (such as taste, odor, or color) in drinking water. EPA recommends secondary standards to water systems but does not require systems to comply.

 

This too makes no sense given the fact that the current 1.0 ppm level results in fluorosis.

 

The secondary MCL of 2 ppm or 2,000 ppb only requires that when natural fluoride levels are that high that notice be published warning users that fluorosis may result.

 

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In 1979 the FDA and the EPA entered into an inter-agency treaty, a Memorandum of Understanding, numbered MOU 225-79-2001,[80] This Memorandum included these provisions:

 

[There is] the possibility of overlapping jurisdiction between EPA and FDA with respect to control of drinking water additives has been the subject of Congressional as well as public concern. … [T]he authority to control the use and application of direct and indirect additives to and substances in drinking water should be vested in a single regulatory agency to avoid duplicative and inconsistent regulation. … [The] EPA has been mandated by Congress under the Safe Drinking Water Act (SDWA), as amended, to assure that the public is provided with safe drinking water. … [The] FDA has been mandated by Congress under the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended, to protect the public from, inter alia, the adulteration of food by food additives and poisonous and deleterious substances. … [The] EPA will have responsibility for direct and indirect additives to and other substances in drinking water under the SDWA … and [the] FDA will have responsibility for water, and substances in water, used in food and for food processing and responsibility for bottled drinking water under the FFDCA. … In the past, FDA has considered drinking water to be a food under Section 201(f). However, both parties have determined that the passage of the SDWA in 1974 implicitly repealed FDA’s authority under the FFDCA over water used for drinking water purposes. Under the express provisions of Section 410 of the FFDCA, FDA retains authority over bottled drinking water. Furthermore, all water used in food remains a food and subject to the provisions of the FFDCA. Water used for food processing is subject to applicable provisions of FFDCA. Moreover, all substances in water used in food are added substances subject to the provisions of the FFDCA, but no substances added to a public drinking water system before the water enters a food processing establishment will be considered a food additive. … The expressed intent of the [SWDA] was to give EPA exclusive control over the safety of public water supplies. … EPA’s responsibilities are … [t]o establish appropriate regulations, and to take appropriate measures, under the SDWA …, to control direct additives to drinking water (which encompass any substances purposely added to the water), and indirect additives (which encompass any substance which might leach …). FDA’s responsibilities are [t]o take appropriate regulatory action under the authority of the FFDCA to control bottled drinking water and water, and substances in water, used in food and for food processing; [t]o provide assistance to EPA to facilitate the transition of responsibilities, including: … [t]o review existing FDA approvals in order to identify their applicability to additives in drinking water…; [t]o provide a senior toxicologist to help EPA devise new procedures and protocols to be used in formulating advice on direct and indirect additives to drinking water. … EPA’s responsibilities are as follows: … [t]o establish appropriate regulations, and to take appropriate measures, under the SDWA … to control direct additives to drinking water (which encompass any substances purposely added to the water), and indirect additives (which encompass any substance which might leach …). [emphasis added]

 

Note that the agencies agreed that the FDA would

 

… control bottled drinking water[81]and water, and substances in water, used in food and for food processing….

 

Note that the EPA would

 

“… take appropriate measures, under the SDWA … to control direct additives to drinking water (which encompass any substances purposely added to the water).

 

This would include adding fluoride. Some argue that the FDA never relinquished authority over adding fluoride used for drug or medical purposes, however, the plain wording of the Memorandum says otherwise.

 

There were and are problems with this deal. First, only Congress can change a federal statute. Agencies cannot cede their authority to each other, which is clearly what the FDA and EPA were pretended they were doing.

 

If the FDA did have power to assign to the EPA a task Congress gave it, the EPA was barred from receiving that power or filling that role, because

the SDWA prohibited the EPA or any agency from creating any national primary drinking water regulation which would require adding any

 

substance for preventive health care purposes unrelated to contamination of drinking water.

 

The net result was that the FDA was unwilling to regulate water fluoridation, apparently because fluoride was a political hot potato, and the EPA was legally barred from regulating water fluoridation, although the 1979 Memorandum of Understanding[82] between FDA and EPA made it appear that the EPA could do so.

 

On paper the FDA was transferring authority to the EPA to regulate fluoridation. Perhaps FDA believed that the EPA would use its authority to ban and not authorize fluoridation. I will go into this issue in greater detail below.

 

It appears that EPA had other ideas. They wanted to use the new found EPA power to promote fluoridation. Nevertheless, in actually applying its purpose, the EPA apparently realized that it was limited by the SWDA provision of 1974, which said that EPA could not enact any “national primary drinking water regulation” which would require

 

the addition to drinking water of any substance for preventive health care purposes unrelated to contamination of drinking water.

 

There are two ways to interpret this law. The probable intent of the law was that adding fluoride or any other chemical to drinking water for medicinal purposes was to be forbidden. Unfortunately, Congress drafted the law poorly.

 

Others interpret the SDWA narrowly to mean that as long as the EPA does not actually require fluoridation, it can do anything short of requiring it, including approving, financing, and promoting fluoridation, provided that local water districts make the final chose to implement fluoridation. However, this interpretation would be contrary to the “restore and maintain the chemical, physical, and biological integrity of the Nation’s waters”[83] language of the SDWA prologue.

 

Bear in mind that the Memorandum was entered into in 1979 during the Carter administration. Once the Reagan administration took office in 1981, EPA administrators were appointed who were biased[84] in favor of the chemical industry. The new pro-business EPA administrators reversed decisions about setting a low MCL for fluoride. The goals of these new administrators were at odds with the good-science goals and attitudes of the EPA scientists. Privization was favored by the Reagan administration. There were internecine wars between administrators and scientists. The National Resources Defense Council sued EPA over its lax fluoride standard, and the EPA scientists union joined the suit.[85] Bill Hirzy spoke for the Union[86].

 

Presumably, because of the 1974 restriction, the EPA was wary of approving and certifying fluoridation materials. Apparently, it decided that the next best thing would be to appoint some other group to approve and certify.

 

Thus, in 1985 the EPA began funding and training NSF,[87] to certify fluoride as safe and effective, in effect to produce a certification of fluoridation materials that only the FDA could by law issue. The EPA did not own the powers it assigned, nor did it have power to assign such powers.

 

By 1988, the work was done. The EPA had turned over authority to NSF to approve fluoridation materials[88] and other additives to drinking water. Quoting from an NSF fact sheet:

 

In 1988, the U.S. Environmental Protection Agency (EPA) replaced its own drinking water additives program with NSF/ANSI Standards 60 and 61, which set public health standards for all chemicals used to treat water and products coming into contact with drinking water[89] ….

 

Tudor Davies, former director of the EPA Office of Science and Technology, in his April 2, 1998, letter[90] to George Glasser, adds this:

 

In the United States, there are no Federal safety standards which are applicable to drinking water additives, including those intended for use in fluoridating water. In the past the EPA assisted the States and public water systems through the issuance of advisory opinions on acceptability of many additive chemicals. However, the Federal advisory program was terminated on October 4, 1988, and EPA assisted in establishment of voluntary product standards at NSF International (NSF) …. NSF Standard 60 … was developed by … a consortium of representatives from utilities, government, manufacturers and the public health community. [emphasis added]

 

Tudor Davies is wrong on this point. There is no Federal safety standard regarding adding fluoride to drinking water because they are not safe and not effective. There are safety standards which would allow the FDA or the EPA to ban fluoridation, but neither agency acts.

In 1988 the EPA announced the “Termination of the Federal Drinking Water Additive Program”, the termination to go into full effect on April 7, 1990. 53 FR 25586-89.[91] The Termination mentioned the 1979 Memorandum of Understanding[92] between FDA and EPA. It quotes the line from the Memorandum that said that

 

… passage of the SDWA in 1974 repealed FDA’s authority under the FFDCA over water used for drinking water purposes.

 

The Termination did not elaborate on the 1979 FDA transfer of that authority to the EPA. Nevertheless, the Termination did discuss in detail EPA’s transfer of authority over drinking water additives to NSF.

 

The 1979 Memorandum had said “This [Memorandum] shall continue in effect unless … terminated by either party upon thirty (30) days advance written notice to the other.” The 1988 Termination announcement does not explicitly say that the 1979 Memorandum was terminated, however, because EPA was renouncing any authority to regulate additives to water and because the Memorandum was mentioned, the Termination had to mean that the EPA was giving notice to the FDA that the 1979 Memorandum itself was terminated.

 

Some FDA representatives do not seem to be aware that the EPA terminated the 1979 Memorandum in 1988.  FDA continues to point to the 1979 Memorandum as a reason why it does not ban fluoridation or demand a New Drug Application for fluoridation materials.

 

In 1994 Congress adopted[93] the Dietary Supplement Health and Education Act (DSHEA),[94] which amended the FDCA Act of 1938. The DSHEA contained explicit statutory language that classified minerals as dietary supplements. Fluoride of course is a mineral and therefore is a dietary supplement under DSHEA. 21 USC 321(f)(1)(B).[95] Minerals are normally regulated as foods except when they are drugs.

 

Fluoride is a mineral. The DSHEA made it clear that minerals including fluoride are drugs if their intended use is to prevent disease.

 

A dietary supplement is deemed to be” food,” [21 USC] 321(ff), which is defined in part as “articles used for food or drink for man or other animals,” [21 USC] 321(f)(1), except when it meets the definition of a “drug,” which is defined in part as “articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals.” Alliance for Natural Health, US v, Sebelius, 714 F’supp,2d 48,50 (DDC 2010).

 

Under the DSHEA dietary supplements include minerals. 21 USC 321 (ff)(l)(D). In adopting the DSHEA, Congress clarified its intent that fluoride minerals when used to prevent disease are drugs under federal law. 21 USC 321(ff)(postscript).

 

Note that 21 USC 321[96], which defines the term “drug”, states: “except for purposes of [21 USC 321(g) defining drugs] a dietary supplement shall be deemed to be a food”. Whether food or drug, fluoride should fall under FDA jurisdiction.

 

Perhaps Congress added these provisions to the DSHEA to counter the FDA’s 1952 declaration made to please the Public Health Service that fluoridation would not be actionable[97]. Fluoride got a pass from the FDA under some theory that fluoride was an OTC drug or a supplement or a mineral. I presume this to be so because the 1952 declaration was passed immediately after the Durham-Humphrey Amendment of 1951 (65 Stat. 648) was passed, which created the OTC drug category.

 

Recall that in 1972, the FDA established a new approval process for nonprescription drugs. 21 CFR 330.[98] This process resulted in the establishment of over-the-counter (“OTC”) monographs for various drug classifications of drugs including a monograph for anticaries drug products that do not require a prescription. (21 CFR 355.)[99] FDA maintains a list of OTC active ingredients[100] and related monographs. The anticaries monograph, found at 21 CFR 355[101], relates only to anticaries remedies such as toothpaste, which are not to be swallowed. There is no monograph for fluoride drugs to be ingested except for a fluoride rinse, but this drug is distributed only to health care providers.

 

Fluoride added to drinking water clearly meets the definition of a drug. All drugs are either prescription drugs or OTC drugs. No prescriptions were being handed out, so fluoride vendors could not claim fluoride was a prescription drug. That left the OTC option. Could fluoride added to drinking water classify for the OTC designation? Hardly. A cursory reading of 21 CFR 330, which applies to all OTC drugs and 21 CFR 355, which applies to anti-caries OTC drugs shows the answer to be a definite No, simply because fluoride is sold in bulk and is not pharmaceutical grade.

 

The final OTC rule in 1995 provided that all OTC anticaries drug products introduced to the market after April 7, 1997, would have to comply with general conditions in 21 CFR 330.1[102] and with anticaries monograph conditions in 21 CFR 355[103]. Otherwise a NDA or AND is required.

 

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In 1996, the FDA determined that its 1952 regulation[104], reworded and found at 21 CFR 250.203[105] was obsolete or no longer necessary and that it was revoked. 61 FR 29476.[106] FDA was announcing that it was revoking its old commitment to the Public Health Service and *the that adding fluoride to drinking water was not actionable[107].

 

The revocation of the 1952 regulation occurred after the EPA announced its  “Termination of the Federal Drinking Water Additive Program”, which became effective April 7, 1990. 53 FR 25586-89.[108]

 

The purpose of The 1979 Memorandum of Understanding between FDA and EPA was to have the EPA operate the federal drinking water additive program. 44 FR 42775-78. EPA’s announcement of its termination of its additive program was effective notice to FDA that the 1979 MOU was terminated. 53 FR 42776. The Memorandum had said: “This [Memorandum] shall continue in effect unless … terminated by either party upon thirty (30) days advance written notice to the other”. EPA could unilaterally terminate the Memorandum, and apparently EPA did, although apparently without giving formal notice to the FDA.

 

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In 1996 the FDA stated: “…based on evidence currently available, there are inadequate data to establish general recognition of the safety and effectiveness of these ingredients for the specified uses”, and then it listed hydrogen fluoride used as an anti-caries agent. Thus any anticaries drug that includes hydrogen fluoride requires an NDA. See 21 CFR 310.545.[109] This regulation is an unenforced, overlooked, or ignored. If it were enforced it would result in a ban of water fluoridation with silicofluoride because silicofluoride breaks down into and is composed of around 1% hydrogen fluoride and 25% silicon tetrafluoride. The same could be said of sodium fluoride. Although it contains no HF, in acid conditions, such as in the stomach, it readily forms HF.

 

Based on this law it is illegal to fluoridate either with silicofluoride or sodium fluoride. An activist or perhaps the state attorney general or county or city attorneys could sue for a restraining order against fluoridation using either chemical.

 

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In 1997 FDA proposed 21 CFR 356[110] as a new regulation, which was later approved.[111] It stated:

 

On or after [April 7, 1997] no OTC drug product that is subject to the monograph and that contains a nonmonograph condition . . . may be initially introduced . . . into interstate commerce unless it is the subject of an approved application or abbreviated application.

 

Fluoridation materials are subject to the monograph but are characterized by nonmonograph conditions, which are for example their sale in bulk and their not being pharmaceutical grade. There is an OTC monograph  for anticaries drugs but there is no monograph for anticaries drugs which are to be swallowed except by prescription. Fluoridation materials meet the definition of drugs and therefore must be either prescription drugs or OTC drugs. Either way they should have FDA approval.

 

Luride is a fluoride tablet[112] which is not approved by the FDA but which is grandfathered in and which the FDA allows to be sold although only by prescription. Fluoride rinses[113] may be swallowed but they are distributed only through health professionals.

 

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In 2000 Congress held hearings on drinking water fluoridation[114], chaired by Representative Ken Calvert. The fluoride opponents made a convincing case. Many of them thought they had done so well that Congress would immediately end fluoridation. Congress did no such thing. Such was the power of the fluoride vendors that they had power even over plain science.

 

During the 2000 hearings Congress wrote to the FDA and asked questions about fluoridation. Questions and answers follow[115]:

 

Calvert:

 

If health claims are made for fluoride-containing products (e.g. that they reduce dental caries incidence or reduce pathology from osteoporosis), do such claims mandate that the fluoride-containing product be considered a drug, and thus subject the product to applicable regulatory controls?

 

FDA Answer:

 

Fluoride, when used in the diagnosis, cure, mitigation, treatment, or prevention of diseases in man or animal, is a drug that is subject to Food and Drug Administration (FDA) regulation. …

 

In the letter FDA says “The EPA regulates fluoride in the water supply”, which indicates that the FDA writer was unaware that EPA had terminated the 1979 Memorandum by withdrawing from the additives program. The letter further implies that the FDA was declaring its right to cancel the Memorandum and retake control of fluoride regulation.

 

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The 2006 NRC Report, Fluoride in Drinking Water[116] was the beginning of the end of drinking water fluoridation. The NRC is considered authoritative. It is an arm of the National Academy of Sciences. The 2006 NRC Report on Fluoride revealed so much about the “flat earthiness” of water fluoridation that it was only a matter of time before policy makers would come to their senses and stop the practice.

 

EPA is required to commission the NRC to review its work periodically, and so the EPA commissioned the 1993 and 2006 NRC reports on Fluoride. This is what NSF said:

Addressing questions of artificial fluoridation, economics, risk-benefit assessment, and water-treatment technology was not part of the committee’s charge. 2006 NRC 1-2[117].

On the one hand, EPA and CDC were endorsing continued water fluoridation, the EPA was promoting fluoridation through NSF and financing NSF, and the CDC was guiding states and cities in building fluoridation facilities through its fluoridation engineering department.

On the other hand, EPA was telling NRC not to research the subject of fluoridation[118]. On the other hand, the EPA was using NRC’s reduced coverage of water fluoridation to imply that the NRC was not critical of water fluoridation.

In the 2006 NRC Report the NRC told the EPA that the 4 ppm MCL action level for naturally occurring fluoride should be lowered. The NRC did not say what the new lower level should be. The NRC said that the EPA should commission studies to determine what the new level should be. The NRC impliedly criticized the EPA for not having done more research on the safety of fluoride. The NRC then gave the EPA a long list of scientific issues that it should research:

fertility, thyroid function, increased calcitonin activity, increased parathyroid hormone activity, secondary hyperparathyroidism, impaired glucose tolerance, and possible effects on timing of sexual maturity, endocrine effects and brain function, osteosarcoma. 2006 NRC Report[119], pages 6-9.

However, the EPA and HHS failed to do their homework. They ignored most of the questions NRC posed and wrote almost exclusively about fluorosis and caries reduction. Their posted poorly designed studies on their web sites which showed fluoride results typically in a 17% to 25% reduction in caries, along with the Beltrane study showing 41% of children age 12-15 getting fluorosis[120] and the CDC study finding that the effect of fluoride is topical only[121]. The EPA and HHS were admitting that their position was wrong but they were still supporting only a reduction in fluoridation level to .7 ppm and not a complete termination of fluoridation.

 

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In early 2011 HHS and EPA issued their proposed regulation regarding reducing recommended fluoridation levels from the current range of .7 ppm to 1.2 ppm to a flat .7 ppm. There was no logic offered as to why the fluoride concentration should be lowered only 30% instead of eliminated entirely. Many of the case studies cited by HHS and EPA describe serious dental fluorosis and do the opposite of supporting evidence for fluoridation.

 

In my Fluoride Report Card for HHS and EPA[122] I made a long list of the illogical and inconsistent nature of the joint proposals coming from HHS and EPA. In my Comments To HHS and EPA Regarding Lead, Arsenic, And Water Fluoridation[123], I discussed another EPA and HHS blindspot: Their fluoridation materials are poisoning the nation’s children with lead.

 

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As late as 2010 when I talked with chief fluoridation engineer Kip Dujon, the CDC still had fluoridation engineers on staff. Kip’s phone number is 770-488-6054.

 

The EPA said in 1988 that it was getting out of the water additives business, but it didn’t. It is still promoting fluoridation – in partnership with NSF. As late as March of 2010, the EPA had an “Environmental Technology Versification Program (ETV) for drinking water systems, a program administered by NSF”.[124]

 

To this day, the CDC and the EPA continue with their behind-the-scenes, indirect, and unauthorized promotion, authorization, facilitation, financing, and regulation of drinking water fluoridation. Their behavior analogous to Oliver North running the Contra War out of the Whitehouse basement.

 

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Should fluoridation materials—to be put in our drinking water—be tested and approved by some federal or state agency? Who should do the testing and approval? CDC? EPA? FDC? State boards of health? State boards of pharmacy? Should fluoridation materials be pharmaceutical grade or industrial toxic waste grade?

 

Is it acceptable to privatize the regulation of such chemicals and turn it over to a trade association which is subject to undue influence by the chemical industry? Is it acceptable that that federal agencies such as CDC and EPA finance and direct the implementation of and use use of fluoridation materials which they have never tested or certified to be safe?

 

The Centers for Disease Control (CDC) is the biggest cheer leader for drinking water fluoridation.[125] The CDC is a department of HHS, as also is the FDA. The CDC began as a department under the Public Health Service, which was once a branch of the military. Later CDC came under the jurisdiction of HHS. The CDC has no jurisdiction over water fluoridation, however, it leads financially in efforts to spread the implementation of fluoridation. As mentioned previously, it has its own fluoride engineering department which assists states and water districts in getting the laws passed to establish fluoridation anywhere possible. However, the CDC has no legal jurisdiction over any aspect of water fluoridation and no authority whatsoever to hire fluoridation engineers who counsel water districts in how to fluoridate and politicians in how to pass mandatory fluoridation laws. Such behavior on the part of the CDC makes it a party to a multi-party effort to establish a de facto national primary drinking water regulation which would require “the addition to drinking water of any substance for preventive health care purposes unrelated to contamination of drinking water.”

 

I know of no surgeon general who has not been a proponent of fluoridation. It would seem to be a prerequisite for getting the job. The current Surgeon General, David Satcher[126], is a true believer when it comes to fluoridation. I know of not one single surgeon general who was opposed to water fluoridation. However, the Surgeon General also has no jurisdiction over water fluoridation.

 

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The EPA – on the administrative level – is also a big promoter of water fluoridation, although EPA scientists are dead set against it. The EPA administrators were so eager about fluoridation that they trained and financed the NSF in how to regulate water fluoridation and then transferred the authority which EPA had apparently received from FDA under the 1979 Memorandum to the NSF. But the EPA as well has no legal authority to authorize, regulate, or require water fluoridation. Yet it still funds and inspects and even certifies in a convoluted way the work of the NSF, including the NSF Standard 60 monograph on drinking water fluoridation.

 

The EPA cannot legally authorize fluoridation, but it could ban it, as could the FDA. The EPA bans many chemicals. See, for example its banned pesticides list.[127] Under the Toxic Substances Control Act the EPA has powers to ban chemicals[128]:

 

Under TSCA Section 6, EPA can ban manufacture or distribution in commerce, limit use, require labeling, or place other restrictions on chemicals that pose unreasonable risks. Among the chemicals EPA regulates under Section 6 authority are asbestos, chlorofluorocarbons (CFCs), lead, and polychlorinated biphenyls (PCBs).

 

Likewise, the EPA has banned ozone depleting chemicals.[129]

 

EPA scientists have long opposed fluoridation,[130] but EPA administrators, who are often not scientists, have support it. Like a small nation, the EPA has its own political parties, the pro-industry party and the pro-science party. Agency heads often have worked for and taken money from the big chemical corporations which the EPA regulates. The system has been corrupted by money. The same can be said of the CDC.

 

The Safe Water Drinking Act (SDWA) is administered by and regulates the actions of the the EPA in connection with drinking water. Note that the SDWA specifically states at 42 USC 300g-1(b)(11)[131]:

 

No national primary drinking water regulation may require the addition of any substance for preventive health care purposes unrelated to contamination of drinking water.

 

The EPA may require that naturally occurring or manmade contaminants be removed if they exceed MCL maximum contaminant levels. For fluoride it is 4 ppm. The reference to 4 ppm is primarily a reference to calcium fluoride, because calcium fluoride is the most commonly occurring natural form of fluoride. The 4 ppm rule on fluoride is a requirement to remove fluoride from drinking water if there is too much of it, not to add any amount of it. The EPA may require or authorize the addition of substances to water, but only those which remove or neutralize contaminants.

 

Many think that because the SDWA has a 4 ppm maximum contaminant level (MCL) for fluoride, that the SDWA authorizes the insertion of fluoride up to a 4 ppm maximum. This is not so. The SDWA only requires removal of fluoride if it exceeds 4 ppm. The 2006 NRC Report at page 13,[132] clarifies this:

 

In 1986, EPA established an MCLG [maximum contaminant level goal] and MCL [maximum contaminant level] for fluoride at a concentration of 4 milligrams per liter (mg/L) and an SMCL [special contaminant level] of 2 mg/L. These guidelines are restrictions on the total amount of fluoride allowed in drinking water. … EPA’s drinking-water guidelines are not recommendations about adding fluoride to drinking water to protect the public from dental caries. …  Instead, EPA’s guidelines are maximum allowable concentrations in drinking water intended to prevent toxic or other adverse effects that could result from exposure to fluoride.

 

Substances “for preventive health care purposes unrelated to contamination of drinking water” should not be added, and that would include drugs. Fluoride mixed with water at 1 ppm meets federal definitions of “drug” and “medication.”[133] It would also meet state definitions. This is because fluoride is added to prevent or treat disease. I will say more about this later.

 

So it comes as a big surprise to those who delve into this highly convoluted area of law and history to learn that the EPA as administrator of the SDWA regulates only the removal of contaminants which naturally appear in water or which have been added through pollution. The SDWA does not authorize adding chemicals except for chemicals which remove or neutralize contaminants. Thus, authorizing the addition of fluoride to drinking water does not fit within the EPA’s purview.

 

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The NRC analysis at 2006 NRC Report, page 13,[134] referred to in the previous section, would also apply to lead and arsenic. The MCL for lead is 15 ppb; for arsenic 10 ppb. However, the MCLG for each is zero.[135] The 15 ppb and 10 ppb MCLs are not authorization to add lead and arsenic up to 15 ppb or 10 ppb but a mandate to take action and remove them if they exceed that level. The zero MCLG is a statement that none should be added; if the goal is zero, one does not get closer to that goal by adding any lead or arsenic. The EPA may not authorize the addition of lead or arsenic to drinking water, however, the NSF does, claiming to have received authority to do so from the EPA and claiming that the EPA is in continual approval of its work[136].

 

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The February 2008 NSF Fact Sheet on Fluoridation Chemicals[137], admits that fluosilicic acid contains lead and arsenic:

 

[F]luosilicic acid is produced by adding sulfuric acid to phosphate ore. This is typically done during the production of phosphate additives for agricultural fertilizers. … The most common contaminant detected in these products is arsenic …. The current MCL for arsenic is 10 ppb, the highest detection of arsenic from a fluoridation chemical was 0.6 ppb …. The third most common contaminant found is lead … with 0.6 ppb being the highest concentration detected [emphasis added].

 

Seattle adds silicofluoride to its water, which contains lead and arsenic[138] to its water. Everett does the same.[139] Don’t forget that silicofluoride not only contains lead but also leaches lead from pipes and fittings.

 

There has been no updated NSF Fact sheet on fluoridation since the 2008 NSF Fluoride Fact Sheet. Before that you have to go back eight more years to read the equivalent of a fact sheet, as found in a letter dated April 24, 2000, in which NSF official Stan Hazan[140], admitted to maximum lead levels of 1.1 ppb, and maximum arsenic levels of 1.66 ppb. Compare the July 7, 2000, letter Hazan wrote to Representative Calvert, in which lead and arsenic levels were similar[141].

 

The MCLG, the maximum contaminant level goal, for arsenic and lead are both zero. See 40 CFR 141.51[142]. An MCLG of zero means none should be added. As discussed above, one does not get closer to a zero goal by adding any of these toxins. These chemicals are so nasty that there is no justification for adding any of them to drinking water.

 

Fluoride is a little more toxic than lead, a little less toxic than arsenic. The MCL for lead is 15 ppb; the MCL for arsenic is 10 ppb; but the MCL for fluoride is 4.0 ppm[143], that is 4,000 ppm. Clinical Toxicology of Consumer Products, LD 50[144].

 

The EPA and CDC cannot authorize adding lead and arsenic to drinking water any more than they can authorize adding fluoride. Nor can the NSF sham-agency.

 

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Given that no federal agency is empowered to write regulations which require that fluoride be added to drinking water, the next question is whether states can require fluoridation by statute or whether state agencies can do so by regulatory action.

 

Because the SDWA prohibits enacting a national primary drinking water regulation requiring “the addition of any substance for preventive health care purposes“ and because the SDWA requires that state “… drinking water regulations” be “no less stringent than the national primary drinking water regulations,”[145] it can be argued therefore that state regulations likewise must be so limited, and therefore that state regulatory agencies may not enact regulations which require municipalities to add fluoride or any other medication intended for “preventive health care purposes.” State mandatory fluoridation laws violate the Safe Drinking Water Act.

 

In Washington the Department of Health is the lead agency for enforcement of the SDWA in Washington, but, like the EPA, it too is bound by the limitations of the SDWA and is forbidden by the SDWA from writing a regulation requiring the addition to water of “any substance for preventive health care purposes unrelated to contamination of drinking water.”[146] Technically the Department of Health does not require the addition of fluoride to water, it merely says that if a municipality fluoridates, it must follow certain fluoridation practices including WAC 246-290-460.[147] It also says that any fluoridation materials used must conform to NSF Standard 60.[148]

 

In each state there is a lead agency which is empowered to administer the SDWA, and in Washington, for example, that agency is the Department of Health. RCW 70.119A.080,[149] RCW 43.21A.445.[150] The EPA has granted primacy to the states to implement the SDWA on the state level. It is a federal, not a national arrangement. 40 CFR 42.10. In RCW 43.21A.445[151] several Washington agencies led by the Department of Health are “… authorized to participate fully in and are empowered to administer …” the SDWA.

 

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This prohibition against enacting any national primary drinking water regulation requiring “the addition of any substance for preventive health care purposes” arguably flows down to the states, but does it flow down further to municipalities? The answer is arguably Yes. 40 CFR 142.3[152] provides:

 

… [T]his part [40 CFR Part 142—National Primary Drinking Water Regulations Implementation] applies to each public water system in each State.

 

40 CFR 142.2[153] defines a “public water system” thus:

 

Public water system or PWS means a system for the provision to the public of water for human consumption through pipes or, after August 5, 1998, other constructed conveyances, if such system has at least fifteen service connections or regularly serves an average of at least twenty-five individuals daily at least 60 days out of the year.

 

Using the wording of this federal regulation, it would appear that a city council or water district which votes to fluoridate has enacted a “drinking water regulation” which requires “the addition of” a “substance for preventive health care purposes unrelated to contamination of drinking water,” namely fluoride. If the limitations imposed by the SDWA do flow down to municipalities, then a decision by a city or water district to fluoridate is contrary to federal law.

 

The conclusion then is that “the buck stops” at the water district office. It is the municipalities which assume the liability of requiring fluoridation. The water district makes its decision based on the false assurances of a sham regulatory agency that fluoridation materials are safe. Washington law requires that they rely on this sham regulatory agency; it does not require that the water district make any further inquiry.

 

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So we return to our original question: Who or what is NSF? The July 7, 2000, letter from Stan Hazan, then NSF general manager, to Rep. Ken Calvert helps answer this question:[154]

 

NSF involvement in the evaluation of drinking water chemicals, including fluoride-based chemicals, began in 1985, when the U.S. EPA granted an NSF-led consortium of stakeholders the responsibility to develop consensus, health-based, quality specifications for drinking water treatment chemicals and drinking water system components. [emphasis added]

 

A “specification” is the equivalent of a regulation. The NSF 60 standard is recognized by law as authorizing the use of fluoridation materials which meet the NSF 60 standard. It is therefore a ““national primary drinking water regulation”.

 

NSF proceeded to construct the NSF Standard 60 rule. The “NSF 60” logo is stamped on every fluoride shipment bill of lading. The Hazen letter[155] continues:

 

NSF 60 Drinking Water Treatment Chemicals – Health Effects” was initially adopted in December 1987, and was last revised in May 2000. The standard was developed using a consensus standards development process with representation of the major stakeholder interests, including product manufacturers [emphasis added]….

 

The industries which produce fluosilicic acid are on the board which develops the standards that regulate fluoridation materials.

 

The NSF 60 document says without equivocation that toxicological studies will be done[156], as does the February 2008 NSF Fact Sheet on Fluoridation Chemicals[157]:

 

The NSF Joint Committee … consists of … product manufacturing representatives. … Standard 60 … requires a toxicology review to determine that the product is safe at its maximum use level and to evaluate potential contaminations in the product. … A toxicology evaluation of test results is required to determine if any contaminant concentrations have the potential to cause adverse human health effects. … NSF also requires annual testing and toxicological evaluation …. The NSF standard requires … toxicological evaluation.

 

Thus, NSF repeatedly refers to “health” above and insists that there are “toxicological evaluation[s]” to avoid “adverse human health effects”. NSF repeatedly refers to having toxicologists on staff.[158] and having its own toxicological[159] department.[160] [161]

 

NSF has this to say about the “NSF Mark”[162] on its web site:

 

The next time you are shopping for a food or water-related product that may potentially affect the health of you or your family, look to see if the NSF Mark is on the product. This Mark is your assurance that the product has been tested by one of the most respected independent certification companies in existence today, NSF International.

 

However, NSF official Stan Hazan in his letter to Representative Ken Calvert[163] introduced some doubt as to whether there are toxicological studies:

 

The standard requires that the manufacturer of a product submitted for certification provide toxicological information, if available. NSF requires that manufacturers seeking certification to the standard submit this information as part of their formulation or ingredient supplier submission. … [emphasis added]

 

Even if such studies are provided, the public is not allowed to read them.

 

Individual test reports, as well as formulation information are protected by nondisclosure agreements with certification clients.

 

It is hard to prove something does not exist, but there is substantial evidence that NSF has no toxicological studies on fluoridation materials or that if they do exist that the results are too embarrassing to fluoride suppliers and NSF for them to be revealed.

 

The evidence, first, is that there are no toxicological studies of fluoridation materials on the extensive NSF web site at www.NSF.org. Blake Stark is the person at NSF International now in charge of fielding questions regarding Standard 60. Call Blake at 734-769-5480 or email him at Stark@NSF.org and ask him if there are any toxicological studies. He is an honest guy. He will tell you there are none as he told me. See an example of a Blake Stark response to my request to him for toxicological studies.[164] See also a transcript of a California deposition (pages 22, 67) [165] in which NSF official, Stan Hazen, has admitted under oath that toxicological studies were not done or available:

 

NSF failed to follow its own Standard 60 procedures, and because we had no tox data on the HFS, then that was — we discussed again how the tox — toxicology department fulfills the Standard 60 requirements by relying on the individual MCLs for the — for the different elements within HFSA.

 

Note that Hazan says that NSF improvised toxicological data by simply looking at the maximum contaminant levels for the components of hydrofluorosilicic acid, hydrogen fluoride and silicon tetrafluoride, which which hydrofluorosilicic acid breaks down into depending on the pH level.

 

∞∞∞

 

NSF apparently does non-toxicological tests on fluoridation materials, apparently analyses of the contents of fluoridation materials. NSF does such tests only rarely. On April 24, 2000, NSF responded to the State of Florida Department of Public Health[166] stating:

 

There are 77 facilities that either produce or repackage fluoride containing treatment chemicals. . . These products (Hydrofluosilicic and Fluosilicic acid, Sodium Fluoride, and Sodium Silicofluoride) have been tested more than 100 times [since 1992] in our laboratories.

 

Let’s do a little math[167], as Dr. Bill Osmunson suggests in his article on batch testing[168]. Assuming generously that the “more than 100 times” referred to was 200 tests done over the eight year period in question, there would be an average of only 25 tests per year done nationwide. Given that there are 77 facilities, there would be an average of .32 tests per year or around one test every three years done at each facility. Assuming that each of the 77 facilities was shipping 200 batch tanker loads per year, the likelihood of any one batch being tested was .32/200 = .00162 = .162%. Thus the likelihood that any tanker load arriving at Seattle or Everett is tested is the inverse of .162%, meaning that only around one in every 617 tanker loads is batch tested.

 

Further, there is nothing to stop the chemical companies from selecting which batch is to be tested and to clean it up or not to stir it, so that the heavy metals which sink to the bottom are not sampled.

 

George Glasser, environmental journalist, says that silicofluoride is radioactive[169], containing uranium[170], radium, polonium, and other hazardous elements and chemicals.

 

Infrequent batch testing is the equivalent of no testing. The NSF 60 mark is a certification that fluoridation materials are not harmful to health, which is required by law in 47 states and 9 provinces based on batch testing which is almost never done and based on toxicological testing which is never done or if done is embarrassing to reveal, and in any case, even if done, are not available for review.

 

∞∞∞

 

NSF took over fluoride regulation from the EPA but NSF Standard 60 is a private document. To read it you must pay $325 for it[171]. The Everett water department does not even posses a copy of the Standard 60 book. Nevertheless, WAC 246-290-220(3) requires Washington water districts to use only NSF 60 approved treatment chemicals. Hazen brags[172] that some 47 states and nine provinces[173] have similar laws. NSF is a private trade group that has apparent governmental authority and carries out functions normally conducted only by government agencies.

 

The EPA lacked authority to regulate the addition of fluoride to drinking water, but the EPA set up the NSF, and NSF right away wrote Standard 60 under the guidance of the EPA and started approving fluoridation materials as safe and not harmful to health and authorizing their addition to drinking water. NSF became a privatized sham-FDA.

 

Note that, according to Hazen,[174] NSF claims to follow the EPA 4 ppm Maximum Contaminant Level for fluoride:

 

NSF has based its certification on the product use not exceeding the EPA’s MCL [maximum contaminant level] for fluoride. [emphasis added] …

 

Hazan’s letter refers to “product use not exceeding the EPA’s MCL”, a clear indiciation that he is talking about adding fluoride and doing so based on a maximum amount added of 4 ppm, which is the EPA MCL. Thus, NSF uses the EPA 4 ppm MCL in a way which the EPA could not use it, that is to authorize the addition of fluoride to drinking water. Maybe this shows that the people running NSF do not understand or do not care what the SDWA does not allow. [emphasis added]

 

Hazen continues:[175]

 

Contaminants in the finished drinking water are not permitted to exceed one-tenth of the EPA’s regulated MCL (Maximum Contaminant Level) when the product is added to drinking water at its Maximum Use Level, unless it can be documented that a limited number of sources of the contaminant occur in drinking water.

 

This shows that NSF does not even follow its own rules. Instead of setting a .4 ppm MAL, maximum allowable level, which would be one-tenth of the EPA 4.0 ppm MCL, NSF sets a 1.2 ppm MAL and justifies it in this way:

 

An MAL of greater than 10% of the MCL can be established by the certification body in limited cases if it can be reasonably documented that there are no other significant sources of the same contaminant, that together, would result in the finished drinking water contaminant concentration exceeding the MCL. Fluoride has an MAL of 1.2 mg / liter, which is 30% of the MCL. This is justified on the basis of the limited number of other potential sources of fluoride ion to drinking water. For example, water that naturally contains sufficient fluoride is not additionally fluoridated, and fluoride is seldom present in other additives.

 

The justification given is that there are no other sources of fluoride that add to the 30 percent load. However, there are many other sources of fluoride besides the fluoride added to drinking water, the greatest being the beverages and foods made with tap water, common fruits and grains sprayed with sulphryl fluoride, and toothpaste accidentally swallowed by children and absorbed through mouth tissues by all. The Environmental Working Group notes, for example, that the EPA allows up to 900 ppm fluoride[176] in dried eggs. One-third of all eggs are dried and then added to a wide range of food products.[177]

 

How does so much fluoride get into dried eggs? Non-organic chickens are fed phosphate fertilizer, which contains fluoride. Non-organic grains can be fumigated with sulfuryl fluoride[178] to kill weevils, and the fluoridated grain is fed to the chickens. Another factor is that the dried eggs themselves are fumigated with sulfuryl fluoride after drying, for long term storage. The maximum fluoride allowed in wheat flour is 125 ppm. Similar levels are allowed in other grains, beans, corn, and other dry products typically stored for long periods of time. Sulfuryl fluoride gradually breaks down, and one of the end products is the fluoride ion.

 

The 2006 NRC study goes into some detail about sulfuryl fluoride[179]. Fortunately, the EPA is requiring that sulfuryl fluoride be phased out. Unfortunately, it may take a while. A substitute needs to be found that will kill the weevils which might infest grains, dried eggs, and other mass produced products which can be saved for long periods of time. My own flippant response to this weevil business is that we should be less concerned about a few weevils in our bread or cakes. I would rather eat organic weevils than sulfuryl fluoride. Weevils are a good source of protein and omega-3 fatty acids. Even under current standards, wheat flour, for example, is allowed to contain up to 150 insect fragments per 100 grams.[180] If that allowable levels of insect parts were raised, we could quit using fumigants. Sulfuryl fluoride is convenient, but there are other ways to control insects, such as cleaning and sealing storage facilities better. Complete control is impossible and unnecessary.

 

∞∞∞

 

Washington law, WAC 246-290-220(3), requires that

 

any treatment chemicals with the exception of commercially retailed hypochlorite compounds such as Clorox, Purex, etc., added to water intended for potable use must comply with ANSI/NSF Standard 60.

 

Some 47 states and nine provinces[181] have similar laws. The states write their laws assuming that the NSF 60 stamp of approval means that the procedures outlined in NSF 60 have been followed. But they have not. Likewise, municipalities pass their fluoridation ordinances assuming that the procedures outlined in NSF 60 have been followed. But NSF 60 is a sham law. According to state law, municipalities must conform to a sham law.

 

Fluoridation can only proceed with materials which meet NSF 60 standards. Current fluoridation materials do not meet NSF 60 standards. Therefore, it is illegal to use current fluoridation materials for drinking water fluoridation.

 

Everett, Seattle, Tacoma, and Port Angeles all use fluorosilicic acid as their fluoridation material. The February 2008 NSF Fact Sheet on Fluoridation Chemicals discusses “fluorosilicic acid”, which is the same thing as “fluosilicic acid or “hexafluorosilicic acid”.[182]

 

Port Angeles is typical. It is “fluorosilicic acid” which Port Angeles is adding to city water. See the October 28, 2008, letter from Gregg Grunenfelder[183] of the Department of health to Eloise Kailin. Mr. Grunenfelder says what pretty much all water districts say:

 

[W]e rely on national certification protocols to ensure the safety of water additives. Specifically, Washington Administrative Code 246-290-220(3), requires that: “Any treatment chemicals … must comply with ANSI/NSF Standard 60…. Since the fluoridation product being used by the city of Port Angeles is certified under NSF Standard 60, the city’s use of this product is in compliance with state law.

 

But the NSF certification which water districts and states rely on and which 47 states and 9 provinces have recognized in statute law as authoritative is bogus, even if it is endorsed and underwritten financially by EPA.

 

If there is any doubt regarding the bogus nature of NSF Standard 60 certification, read through the 2008 NSF Fluoridation Fact Sheet[184] again looking for any reference to the 2006 NRC Report. There is none. NSF standards are outdated. There has not been an updated Fact Sheet since 2008. Water districts are relying on a sham regulation that is also outdated.

 

Tudor Davies, former director of the Office of Science and Technology for the EPA stated the following in his April 2, 1998, letter[185] to George Glasser:

 

In the United States, there are no Federal safety standards which are applicable to drinking water additives, including those intended for use in fluoridating water. In the past the EPA assisted the States and public water systems through the issuance of advisory opinions on acceptability of many additive chemicals. However, the Federal advisory program was terminated on October 4, 1988, and EPA assisted in establishment of voluntary product standards at NSF International (NSF) …. NSF Standard 60 … was developed by NSF by a consortium of representatives from utilities, government, manufacturers and the public health community.

 

When Tudor Davies says there are “no Federal safety standards which are applicable to drinking water additives, including those intended for use in fluoridating water”, he is only half right. There are no standards for authorizing adding fluoridation materials, however, there are standards which would allow the FDA or the EPA to stop fluoridation, namely the Safe Drinking Water Act.

∞∞∞

Most people naively assume that the EPA has jurisdiction over drinking water fluoridation through the SDWA. The EPA helped start NSF and gave it legitimacy. The NSF still brags that it was set up by the EPA. On its history page NSF leads with: “1985 – Drinking Water Additives Program starts with a cooperative agreement from the US EPA.”[186]

 

The NSF pretends to be authoritative, and pretends to have inherited its authority over fluoride from the EPA, and so people trust it when its fact sheet mentions health, safety, inspections, and toxicology. What is going on is that the NSF is pretending to do what the EPA by law is barred from doing, that is to authorize and approve and be part of a de facto national program to require fluoridation everywhere. As part of that authorization and approval program, the official ANSI/NSF 60 mark is stamped on every tanker truckload of silicofluorides.

 

So this is how the shell game works. The FDA had jurisdiction to put a stop to drinking water fluoridation. The FDA bowed to pressure from the Public Health Service and the Federal Security Agency[187] from 1952 until 1996 and waived its jurisdiction, giving fluoridation a “pass”, apparently as an OTC over the counter drug. The FDA entered into the 1979 Memorandum of Understanding with the new EPA. Perhaps the FDA was assuming that EPA, as an independent agency, would ban fluoridation. Or maybe the FDA was just getting rid of a “hot potato”.

 

The EPA received from the FDA authorization to regulate all water additives, apparently including fluoride. However, the EPA only had authority under the 1974 SDWA to ban fluoridation, not to authorize fluoridation. The EPA had an alleged authorization that it could not exercise. So during the Reagan administration pro-industry directors of EPA assigned power it did not have to NSF[188] beginning in 1985. By 1988 the job was done and EPA had delegated authority to NSF[189] to approve fluoridation materials[190] and build up a de facto national regulation approving and currently requiring fluoridation for 70% of water drinkers in the United States.

 

As a final step, the EPA claimed in 1988 that it was washing its hands of the business of authorizing additives to drinking water in its “Termination of the Federal Drinking Water Additive Program”, with the termination to go into full effect on April 7, 1990. (53 FR 25586-89.)[191] The Termination mentioned the 1979 Memorandum of Understanding[192] between FDA and EPA and by implication terminated that Memorandum.

 

The “hot potato” was thus transferred by FDA to EPA, which transferred it to NSF. NSF now functions as a sham FDA, approving fluoride as safe and authorizing its dumping into drinking water. NSF advertises that it does or obtains toxicological studies, but in reality it does not. State laws require that fluoridation can take place only using fluoridation materials which are stamped with the NSF 60 certification. By law water districts are required to conform to a sham regulation issued by a sham agency, NSF.

 

My message for NSF and other certifying bodies such as ANSI, AWWA, and UL is that they should immediately remove their certification of fluoridation materials under NSF 60. NSF is not following the procedures of NSF 60 itself by not requiring toxicological and health studies from the suppliers, nor is it performing those tests itself. On the other hand states are relying on the veracity of the NSF 60 standard in enacting laws requiring that only NSF 60 approved fluoridation materials be utilized for fluoridation. Water districts likewise rely on the veracity of the NSF 60 standard in enacting laws requiring fluoridation.

 

There is considerable evidence that fluoridation is harmful to the health[193] of all over the long term and especially harmful over the short term to certain susceptible populations such as fetuses, infants, diabetics, and those with kidney disease. NSF and other certifying bodies should be concerned about liability for these harms.

 

∞∞∞

 

We have looked at the city councils and water districts, the states, the EPA, the CDC, and the NSF. It is also appropriate to look at the chemical, smelting, and fertilizer companies which produce and sell fluoridation materials.

 

Chemical, smelting, and fertilizer companies which produce sodium fluoride and silicofluoride worked side by side with the EPA to develop the NSF 60 Standard. Stan Hazen, who works for NSF[194] acknowledges that the NSF 60 drinking water standard

 

was developed … with representation of the major stakeholder interests, including product manufacturers ….

 

Chemical, smelting, and fertilizer companies have waste sodium fluoride and silicofluoride to sell. Other chemical companies act as resellers or importers, buying from the fluoride producers and passing along the product. How much revenue and profit is in this business for the actual producers? How much is in it for the resellers and importers? If fluoridation ended tomorrow, what would be the financial impact to the fluoride producers and resellers? Could the silicofluoride and sodium fluoride be sold for other uses? What do sodium fluoride and silicofluoride currently sell for per ton as fluoridation materials? What do they sell for when they are put to other uses? If fluoridation stopped tomorrow, to what level would the price of fluoridation materials drop? Would producers be able to offload the fluoride for a profit? Or would some of the fluoridation materials be unsalable? What would be done to dispose of the fluoride as toxic waste? What would be the cost of doing that? To understand the forces that drive the illicit trade in fluoridation materials and to put an end to it, we should inquire into the economics of the trade.

 

I do not have the final information on the economic impact of terminating fluoridation. This section will continue to be revised as new information is obtained.

 

Vast amounts of silicofluoride waste remains disposed of onsite in Central Florida[195] in football field size lagoons which are surrounded by ten story high gypsum piles. Hurricanes destroyed many of the gypsum piles, resulting in the release of silicofluoride waste into rivers and the Gulf of Mexico. It is my understanding that following the hurricanes, some of the Florida phosphate mines did not restart production and that most silicofluoride is now being imported from China and Mexico where production costs are lower. Some of the storage ponds formed sink holes and broke through the limestone into the Florida aquifer, creating a tragic and permanent pollution of the subterranean river that flows south under Florida to the Everglades.

 

∞∞∞

 

If an aluminum or steel mill has sodium fluoride to sell or if a phosphate fertilizer plant has silicofluoride to sell, how does the company market the product as fluoridation materials? The company applies to one of certifying agencies. NSF is the largest. NSF heads up the consortium which establishes methods and requirements for producing various chemicals, including fluoridation materials.

 

The application process is easy.[196] Around 49 producers or resellers[197] currently qualify for NSF 60 certification for the sale of their fluoride.

 

When producers or resellers sell their chemicals to industry, they make it part of the contract that the buyer accepts all risk in relation to what the buyer intends to do with the product. It has always been part of warranty law that disclaimers of this sort are valid when one is selling a product to a commercial buyer.

 

However, when fluoride producers or resellers include such a disclaimer in their sales to water districts, knowing what the water districts are going to give it to people to drink, a different warranty analysis has to be done: Can an industry disclaim all liability when selling the product to end users who are human beings who have been deceived about the effect of the product on them, and with the producer or reseller having participated in the deception?

 

This is the disclaimer in the MSDS which Mosaic[198] sends to water districts:

 

The information in this document is believed to be correct as of the date issued. HOWEVER, NO WARRANTY OF MERCHANTABILITY, FITNESS FOR ANY PARTICULAR PURPOSE, OR ANY OTHER WARRANTY IS EXPRESSED OR IS TO BE IMPLIED REGARDING THE ACCURACY OR COMPLETENESS OF THIS INFORMATION, THE RESULTS TO BE OBTAINED FROM THE USE OF THIS INFORMATION OR THE PRODUCT, THE SAFETY OF THIS PRODUCT, OR THE HAZARDS RELATED TO ITS USE. This information and product are furnished on the condition that the person receiving them shall make their own determination as to suitability of the product for their particular purpose and on the condition that they assume the risk of their use thereof. The conditions and use of this product are beyond the control of Mosaic, and Mosaic disclaims any liability for loss or damage incurred in connection with the use or misuse of this substance.

 

This is the disclaimer which appears in Univar’s MSDS[199]:

 

Univar USA expressly disclaims all express or implied warranties of merchantibility and fitness for a particular purpose with respect to the product or information provided herein, and shall under no circumstances be liable for incidental or consequential damages.

 

All information appearing herein is based upon data obtained from the manufacturer and/or recognized technical sources. While the information is believed to be accurate, Univar USA makes no representations as to its accuracy or sufficiency. Conditions of use are beyond Univar USA’s control. Therefore, users are responsible to verify this data under their own operating conditions to determine whether the product is suitable for their particular purposes, and they assume all risks of their use, handling, and disposal of the product or from the publication or use of, or reliance upon, information contained herein. This information relates only to the product designated herein and does not relate to its use in combination with any other material or in any other process.

 

This is the disclaimer which appears on the LCI MSDS[200]:

 

The information presented herein is based on data considered to be accurate and that reflects the requirements of the OSHA Hazard Communication Standards in effect as of the date of preparation of this Material Safety Data Sheet. However, no warranty or representation, express or implied, is made as to the accuracy or completeness of the foregoing data and safety information. In addition, no responsibility can be assumed by vendor for any damage or injury resulting from abnormal use, from any failure to adhere to recommended practices, or from any hazards inherent in the nature of the product.

 

Such disclaimers are probably effective when a chemical is being sold to a sophisticated commercial buyer. However, the calculation is different when it is being sold to a water district and its human customers who are uninformed about the potential harm.

 

All 49 of these fluoride producers or resellers have applied for and obtained NSF 60 certification of their fluoridation materials. The 2008 NSF Fact Sheet on Fluoridation Chemicals[201] makes the following representations:

 

The NSF Joint Committee … consists of … product manufacturing representatives. … Standard 60 … requires a toxicology review to determine that the product is safe at its maximum use level and to evaluate potential contaminations in the product. … A toxicology evaluation of test results is required to determine if any contaminant concentrations have the potential to cause adverse human health effects. … NSF also requires annual testing and toxicological evaluation …. The NSF standard requires … toxicological evaluation.

 

NSF also makes these representations in connection with its “NSF Mark”[202]:

 

The next time you are shopping for a food or water-related product that may potentially affect the health of you or your family, look to see if the NSF Mark is on the product. This Mark is your assurance that the product has been tested by one of the most respected independent certification companies in existence today, NSF International.

 

Regarding standards, the NSF web site says:

 

NSF/ANSI Standard 60, first adopted by the NSF Board of Trustees on October 7, 1988, covers … specialty chemicals for treatment of drinking water. The standard addresses the health effects implications of treatment chemicals and related impurities. Both the treatment chemical and the related impurities are considered contaminants for evaluation purposes. The two principal questions addressed are:

1.       Is the chemical safe at the maximum dose, and

2.       Are impurities below the maximum acceptable levels?

NSF/ANSI 60 – 2009 Drinking Water Treatment Chemicals – Health Effects[203], the book which costs $325,  makes the following representations:

 

This Standard establishes minimum health effects requirements for the chemicals, the chemical contaminants, and the impurities that are directly added to drinking water from drinking water treatment chemicals. …

 

This Standard contains health effects requirements for drinking water treatment chemicals that are directly added to water and are intended to be present in the finished water. …

 

NSF/ANSI 60 has been developed to establish minimum requirements for the control of potential adverse human health effects from products added to water for Its treatment. …

 

The Standard and the accompanying text are intended for voluntary use by certifying organizations, utilities, regulatory agencies, and/or manufacturers as a basis of providing assurances that adequate health protection exists for covered products. …

 

NSF was the lead organization in the Consortium responsible for developing this Standard. NSF conducts research; tests and evaluates equipment, products, and services for compliance with standards and criteria; and grants and controls the use of NSF registered Marks. …

 

The NSF Listing Mark is widely recognized as a sign that the product or service to which it relates complies with the applicable NSF Standard(s). …

 

The scope of the research program embraces all aspects of water supply operation, from … water quality issues … to health effects ….

 

This annex defines the toxicological review and evaluation procedures for the evaluation of substances imparted to drinking water through contact with drinking water system components. It is intended to establish the human health risk, if any, of the substances imparted to drinking water under the anticipated use conditions of the product. …

 

If a published and peer reviewed quantitative risk assessment is not currently available for the substance, the Total Allowable Concentration (TAC) and SPAC shall be derived after review of the available toxicology data for the substance. …

 

When the data requirements for quantitative risk assessment are satisfied …, a quantitative risk assessment shall be performed. …

 

For each substance requiring a new or updated risk assessment, toxicity data to be considered shall include but not be limited to, assays of genetic toxicity, acute toxicity …, short term toxicity …,

subchronic toxicity …, reproductive toxicity, developmental toxicity, immunotoxicity, neurotoxicity, chronic toxicity (including carcinogenicity), and human data (clinical, epidemiological, or occupational) when available. To more fully understand the toxic potential of the substance, supplemental studies shall be reviewed, including, but not limited to, mode or mechanism of action, pharmacokinetics, pharmacodynamics, sensitization, endocrine disruption, and other endpoints, as well as studies using routes of exposure other than ingestion. Structure activity relationships, physical and chemical properties, and any other chemical specific information relevant to the risk assessment shall also be reviewed. …

 

A weight-of-evidence approach shall be employed in evaluating the results of the available toxicity data. This approach shall include considering the likelihood of hazard to human health and the conditions under which such hazard may be expressed. …

 

Toxicity testing requirements for the quantitative risk assessment procedure are defined in annex A, table A2. A minimum data set consisting of gene mutation assay, a chromosomal aberration assay, and a subchronic toxicity study shall be required for the performance of a quantitative risk assessment. …

 

[T]he SPAC shall be calculated as 10% of the promulgated regulatory value. …

 

The producers and resellers apply for NSF 60 certification. They know that NSF 60 contains extensive representations regarding the safety and efficacy of fluoridation materials. By applying for and receiving NSF 60 certification, producers and resellers of fluoridation materials are 1) making all the same health and safety representations as NSF makes and 2) negating all the waivers of liability in the producers’ or resellers’ MSDSs and other documents.

 

The involvement of NSF and the producers and resellers of fluoridation in the sham certification of fluoridation materials bears all the marks of a RICO type fraud.

 

My advice to producers and suppliers of fluoridation materials is that they get out of the fluoridation business as quickly as possible. The only defense producers and suppliers can possibly have when the flood of Fluoride-Gate lawsuits come is to argue they ended the sale of fluoridation materials as soon as the wrongfulness of it was pointed out to them.

 

The sooner that the producers and resellers completely renounce this sham certification of fluoridation materials, the more likely is the possibility that its officers, board members, and participating entities will avoid possible liability.

 

∞∞∞

 

The NSF only certifies that fluoridation materials are safe. If the FDA were to authorize fluoridation it would certify them to be not only safe but also effective at reducing tooth decay.

 

The producers and resellers attempt to disclaim all liability, yet they apply for and receive NSF 60 certification, which makes extensive representations about the safety of fluoridation products. These representations benefit the producers and resellers and deceive the water districts and consumers.

 

The shell game is complete. The producers and resellers of fluoridation materials disclaim all liability in the fine print. However, the producers and resellers obtain NSF 60 certification for their toxic product. The states and water districts rely on the NSF 60 certification although the certification is false – because NSF is not enforcing the requirements of NSF 60. Water commissioners are almost always deceived by the shell game.

 

Authority over fluoridation was wrested away from the FDA by a clever EPA but then passed off to NSF.

 

This is a different kind of shell game. In the old days there was a pea under one of the walnut shells. In this case, there is no pea under any of the shells.

On one level there is a certain futility to fluoridation. More and more people refuse to drink tap water and insist on drinking bottled water. We asked the seven members of the Everett City Council if they drank tap water. Only two raised their hands. Two others raised their plastic water bottles, and one said he drank only bottled water. What is the point in putting fluoride in the water if everyone who can avoid drinking it buys bottled water?

∞∞∞

And what about the FDA? To its credit, the FDA withdrew its 1952 “not actionable”[204] classification of fluoridation in 1996 and has never approved fluoridation since. To its fault, the FDA has failed to ban water fluoridation. It has the power to do so. Fluoridation is the mass drugging of 70% of the population with a harmful and unapproved drug. The FDA has also erred in approving Gerber Baby Water and other fluoridated bottled waters. It has allowed bottled water, juices, and other foods to be sold without disclosure as to their fluoride content.

 

On the other hand, it may be that the FDA is making up its group mind and building up its group courage to take action. Recent comments by the FDA hint that it is growing impatient with the situation.

 

It would seem that the FDA would be infuriated at NSF for usurping its role. It should also be infuriated at EPA for helping NSF supplant FDA as the proper regulator of drugs. The FDA entered into a Memorandum with EPA that would have allowed EPA to ban water fluoridation. What did EPA do with that apparent authority but to twist it into authorization of fluoridation and assign it to NSF. EPA passed the job off to a private trade association which goes against science and the law and encourages people to drink toxic substances. EPA administrators helped NSF do it. I predict we will see action soon on the part of FDA against this sham certification. FDA could and should order NSF to cease and desist with its NSF 60 certification program for fluoridation materials.

∞∞∞

 

What should states do to lessen liability? States should immediately repeal mandatory fluoridation laws. They are a blatant violation of the Safe Drinking Water Act. States should repeal laws authorizing the use of fluoridation materials which bear the NSF 60 mark of approval because the mark does not mean what it purports to mean. States should immediately pass a law prohibiting any water district from adding substance to water intended to cure or prevent disease. State attorneys general should go to work on behalf of people harmed by fluoridation by bringing class action or mass toxic tort actions against wrong doers. The cause of action would be for violation of state and federal consumer protection laws, for common law assault and misrepresentation.

 

What should water districts do to lessen liability? They should immediately make fluoridation illegal. They should pass ordinances prohibiting the adding of any substance intended to cure or prevent disease to public drinking water, other than chemicals such as chlorine which are intended to kill bacteria. Water districts should join with states in suits against wrongdoers.

∞∞∞

The intent of the Safe Water Act and the Safe Drinking Water Act are that pollution and contamination of all forms be eliminated in so far as possible[205].

 

The Safe Water Act states:

 

It is the policy of the Congress to … prevent, reduce, and eliminate pollution, to plan the development and use (including restoration, preservation, and enhancement) of land and water resources.

 

The Safe Drinking Water Act also stresses protection of the most vulnerable:

 

The Administrator … shall take into consideration … the effect of … contaminants upon subgroups … such as infants, children, pregnant women, the elderly, individuals with a history of serious illness, or other subpopulations … that are identifiable as being at greater risk of adverse health effects due to exposure to contaminants in drinking water than the general population. …

In carrying out [the requirements of the Safe Drinking Water Act] the Administrator shall use … the best available, peer-reviewed science and supporting studies conducted in accordance with sound and objective scientific practices.[206] [emphasis added]

 

These guidelines are being generally ignored.

 

These laws do not mention the word “organic”, however, only doing things organically would “… prevent, reduce, and eliminate pollution…” and take into consideration

 

“… the effect of … contaminants upon subgroups … such as infants, children, pregnant women, the elderly, individuals with a history of serious illness, or other subpopulations … that are identifiable as being at greater risk of adverse health effects.

 

The best way to protect those at greatest risk would be to do organically everything that can be done organically. We should strive to be an organic nation.

 

Unfortunately our agencies cater to industry first, allowing the production, sale, or dumping of any chemical which makes a profit for chemical companies[207], meanwhile forcing polluted consumers to endure the pollution while the burden falls on consumers to prove the chemicals to be harmful. Unfortunately, chemists crank out new chemicals faster than consumers can convince EPA to ban them. The problem is harder to solve because our regulatory agencies have become captive to the industries they regulate.

My friend and science advisor Dr. Richard Sauerheber has a PhD in chemistry but says he is ashamed of his profession. He says that chemists are consumed with inventing new chemicals or discover new uses for chemicals, usually without asking whether the world would be better off without said chemical. He says most chemists feel obligated to develop uses for their discoveries even if they are toxic to humans, animals and the physical environment.

For example, oysters and clams have prospered nicely for millions of years living organically and providing humans with a potentially endless source of animal protein. But nature is not good enough. Monsanto has convinced oyster and clam farmers that they need to dump Roundup into Olympia’s formerly pristine Willapa Bay, allegedly to kill some eel grass that in some way makes oyster and clam farming less convenient. Any form of agriculture which can be done organically should be done organically.

∞∞∞

 

Fluoride lives in a universe of its own, disconnected from the rest of the scientific and legal world. It is a drug which is treated differently than all other drugs – because there is a myth that it protects teeth. It is a drug which is distributed contrary to a dozen laws. Fluoride was a drug which military and industry wanted to have tested and sold. They donated heavily to universities, which indoctrinated doctors and dentists to spread the fluoridation word. Industry developed a profitable cash flow from the sale of fluoridation materials, which primes the pump that keeps this triangular relationship going. Thus far no agency has had the courage to put a stop to it.

 

End

 

Note: This document is updated as new information is obtained. Look for the date at the top. Go to www.Fluoride-Class-Action.com/sham to read the latest version of this document and to follow internet links.

 

Note: A special thanks goes to Gerald Steel and Eloise Kailin for digging into the legislative history of fluoridation[208] and to Dr. Richard Sauerheber[209] for feedback. I have borrowed quite a few paragraphs from them.

 

See my speech to the Everett City Council on this topic: http://vimeo.com/29647460

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NOTHING BUT A SHAM

Whether the sham artist is a banker or a fluoride producer or reseller,
the problem is a corporate structure ungoverned by a worthy code of ethics
and fixated on unlimited greed