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NATIONAL SANITATION FOUNDATION
SHAM FDA – FRAUDELENT CERTIFIER OF FLUORIDATION MATERIALS
by James Robert Deal, Attorney, President of Fluoride Class Action
www.Fluoride-Class-Action.com/Sham
Submitted August 27, 2015, Revised August 31, 2015
Go to www.Fluoride-Class-Action.com/Sham to follow links.
PURPOSE
This document has been presented and revised to serve four purposes:
This document is suited to offer supporting comment to petition number FDA-2015-P-1977-0001 submitted by Attorney Gerald Steel to the FDA, which proposes that the FDA declare that fluoridation materials (generally referred to inaccurately as “fluoride”) meet the definition of the legal term “drug”. Read Attorney Steel’s petition here. I support his petition and ask the FDA to go further.
The National Sanitation Foundation (NSF) certifies fluoridation materials to be safe. Based on this certification some states and some water districts require that fluoridation materials be added to drinking water. NSF Rule 60 states that some 20 toxicological tests of fluoridation materials must be done. NSF has admitted that the tests are not done. Because states and water districts make the decision to require fluoridation based on NSF’s certification, and because said certification is false and fraudulent, and because NSF is usurping the role of the FDA in certifying the fluoride drug to be safe, the FDA should to order NSF to cease in its certification of fluoridation materials to be safe.
Second, this document responds to a proposed rule made by the Washington Department of Health which would set a new “optimal fluoridation concentration level of 0.7 mg/L.”
My response: The proposed rule should state that the optimal fluoridation level should be zero and that no fluoridation materials should be added to drinking water at all. Washington law allows fluoridation only with materials which “comply with” NSF Rule 60. NSF Rule 60 states that some 20 toxicological tests of fluoridation materials must be done. NSF has admitted that the tests are not done. Therefore, NSF certification is false and fraudulent. The fluoridation materials currently used and available in Washington do not “comply with” NSF Rule 60 and therefore may not be added to drinking water. The Washington Department of Health should declare that fluoridation materials currently used and available do not “comply with” NSF Rule 60 and may not be used for fluoridation.
Third, this document is offered in support of the long pending petition of Dr. Richard Sauerheber to the FDA, numbered as FDA2007-P-0346, which asks that the FDA “ban the intentional infusion of fluorosilicic acid and sodium fluoride into public water supplies, which attempts to prevent dental caries in man but is ineffective and harmful.
Fourth, this document is offered in support of a new petition to the Washington Department of Health which propose that the Washington Department add a Section 6 to WAC 246-290-460, which shall provide that fluorosilicic acid, sodium silicofluoride, and sodium fluoride are no longer approved for use as fluoridation materials in the state of Washington and that approval may be restored and water districts may resume the use of fluorosilicic acid, sodium silicofluoride, and sodium fluoride when and only when AWWI or NSF performs or obtains the above mentioned approximately 20 toxicology tests required by ANSI/NSF Standard 60 and delivers those test results to the Department of Health, and the Washington Department of Health reasonably determines that said tests show that fluoridation materials comply with ANSI/NSF Standard 60 and “… promote public health, safety, and welfare [and provide] … a safe … water supply.
SUMMARY
Fluoridation materials are intended to strengthen teeth and prevent the disease of tooth decay. Therefore, fluoridation materials meet the federal and Washington definition of a drug. The FDA has jurisdiction to approve fluoridation if it were safe and effective or to ban it if it is not both safe and effective. Fluoridation materials and fluoridation are not safe and are minimally effective or completely ineffective in preventing caries.
The FDA has neither approved fluoridation nor banned it. In 1979 the FDA entered into a Memorandum with the EPA, which allegedly transferred authority over all additives to drinking water, apparently including fluoride, to the EPA. The EPA neither approved nor banned fluoridation but instead transferred authority over fluoridation to the National Sanitation Foundation. The EPA financed the initial fluoridation work of NSF and continues to do so. The EPA lent staff to NSF to assist with startup and helped NSF write its NSF Rule 60 Standard. NSF 60 states that some 20 toxicological studies must be done on fluoridation materials. NSF waves this requirement. None of the listed toxicological studies are done, neither by NSF nor by suppliers of fluoridation materials. Yet NSF allows vendors of fluoridation materials to use the NSF Mark, a symbol of compliance with the NSF Rule 60 Standard, and allows vendors to print the NSF Mark on advertising and bills of lading.
The laws of some 47 states and nine Canadian provinces, including Washington, allow fluoridation only with fluoridation materials which “comply with” the NSF Rule 60 Standard. Because the approximately 20 required toxicological studies are not being done, the fluoridation materials do not “comply with” NSF 60, and fluoridation with these fluoridation materials is illegal under state and provincial law.
In falsely approving fluoridation to be safe and authorizing the use of unsafe fluoridation materials, NSF has engaged in a consumer protection act and FTC Act fraud. Because even safe drugs can cause complications for some who take them, they must not only be safe but must also be effective. Fluoridation is either minimally effective in preventing caries (only 18-25% effective according to the CDC) or completely ineffective.
Moreover, NSF has taken actions which only the FDA may take. By certifying fluoridation materials to be safe, NSF has usurped the role of the FDA and is acting as a sham FDA. The FDA should require NSF to cease and desist its false and fraudulent certification of fluoridation materials to be safe and its false impersonation of the FDA.
The FDA should go further and ban fluoridation. The Washington Department of Health should do the same.
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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, usurping the role of the FDA. I refer to the National Sanitation Foundation, more commonly known as “NSF”.
Starting in 1985, the EPA delegated authority to NSF to approve fluoridation materials 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 ….”
Starting in 1985 the EPA sent its experts to NSF to help them get up and running as a fluoridation approving trade association. From the beginning EPA gave NSF money. EPA still gives NSF money 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.
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The 2008 NSF Fluoride Fact Sheet 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.
The 2012 NSF Fact Sheet and the 2013 NSF Fluoride Fact Sheet say essentially the same thing.
NSF also makes these representations in connection with its “NSF Mark”:
“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, a previous version of the NSF web site, quoted by numerous purchasers of NSF certified products, 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?
What I refer to as the NSF Rule 60 Standard book, which is correctly known as NSF/ANSI 60 – 2009 Drinking Water Treatment Chemicals – Health Effects, costs $325. It 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. …
Chemical companies have waste silicofluoride to sell, so they apply to NSF for NSF 60 certification of their product. The approval process 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 contains around 4% fluoride. The heavy metals and the fluoride formerly went up the smokestacks, but thanks to clean air pollution laws fluorosilicic acid and other contaminants 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 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.
EPA official Rebecca Hanmer bragged that fluoridation killed two birds with one stone:
In regard to the use of fluosilicic acid as a source of fluoride for fluoridation, this Agency regards such use as an ideal environmental solution to a long-standing problem. By recovering by-product fluosilicic acid from fertilizer manufacturing, water and air pollution are minimized, and water utilities have a low-cost source of fluoride available to them.
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. The entire super-phosphate fertilizer industry is completely unnecessary. Terminating its production would eliminate the fluorosilicic acid glut and much of the motivation behind fluoridation.
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, 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 by law recognize the NSF Rule 60 Standard stamp of approval as authoritative. These states and provinces allow fluoridation only with fluoridation materials comply with NSF Rule 60 standards, as does Washington.
The states and provinces may regard NSF 60 so highly because the EPA says it “approve[s the NSF Rule 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”.
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 and runs its own toxicological department.
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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 fed to you in your hamburger, hot dog, sausage, or chicken nugget, all of which 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 the tongue and gums and the soft tissues in the mouth.
Toothpaste tastes like candy, 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 fluoridation chemical additives to be safe or effective. We continue to fluoridate water and drink it because respected pro-fluoride dentists and doctors reassure us that it strengthens 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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Naturally occurring fluoride is mostly calcium fluoride, but it is not used for fluoridation. Instead non-naturally occurring fluoride forms – all free of calcium – are used, sodium fluoride (NaF) and two forms of silicofluoride (SiF), fluorosilicic acid and sodium silicofluoride. Sodium fluoride and sodium silicofluoride come in dry form, in crystals like table salt, and are delivered in bags.
Fluorosilicic acid and sodium silicofluoride are cheaper than sodium fluoride. Fluorosilicic acid is a liquid and is more convenient for large water districts to use than granular sodium silicofluoride and sodium fluoride. Granular fluorides are typically used by small water districts.
Fluorosilicic acid comes to Everett and Seattle in 5,000 gallon truck tanker trucks. Everett buys a tanker load every three weeks, around 18 tanker loads per year at around $16,000 per load and spends around $290,000 per year for silicofluoride, a complete waste of money. Everett’s 20 year old fluoridation equipment was worn out and was replaced in February of 2012, another waste of money.
Fluoridation started in 1945 in Grand Rapids, Michigan; Newburg, New York; and Brantford, Ontario. Sodium fluoride was used. 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.
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.
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 fluorosilicic acid, meaning that it can contain the same lead, arsenic, and other contaminants as does silicofluoride. The other small advantage of sodium fluoride is that it does not leach lead from pipes as readily as does fluorosilicic acid.
Most naturally occurring fluoride is in the form of calcium fluoride or fluorite (CaF2). 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 used to fluoridate because it is costs more, is in short supply, has other uses because it is more pure and is free of silicates, which are hard to remove, and because it is not a product that the chemical companies need to unload. With silicofluoride on the other hand, there is a surplus, and suppliers need to get rid of it.
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 than by applying or eating what was formerly used as 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. Fluoridation is a common law assault and battery, and it is fetuses and babies who are hit hardest.
There is considerable evidence that fluoridation is harmful to the health of all over the long term and especially harmful over the short term to certain susceptible populations such as fetuses, infants, diabetics (because they drink so much water), and those with kidney and thyroid diseases. It acts on fetuses and infants to lower IQ. It causes osteosarcoma. It weakens bones and causes fractures. It reduces male fertility.
Fluorosilicic acid contains lead and leaches lead from plumbing. Lead permeates all cells in the body, reduces IQ, and exacerbates kidney disease and high blood pressure.
Some 99% of fluoridated water goes right through treatment plants and back into rivers, where it kills salmon.
NSF and supplies should be concerned about liability for the harms their fraud is causing. If NSF is conspiring with suppliers to commit fraud, and if the fraud causes physical harm, an assault is being committed, and NSF and the suppliers are involved in a continuing criminal conspiracy.
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Silicofluoride contains lead. 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, 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 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 by replacing lead plumbing and lead bubblers, it will not be solving the lead problem overall. There will still be lead bearing pipes in old homes, old apartment buildings, and old commercial buildings. Any structure built before 1986 may contain plumbing made of up to 30% lead. Even in new homes the lead level in brass fittings on sinks are typically 8% lead, so the problem is pervasive.
Silicofluoride contains arsenic, a confirmed Type 1, Class A human carcinogen. It leaches arsenic as well. 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 are carcinogens, mutagens, and poisons. They denature proteins. They are enzyme interrupters. They are anticholinesterase inhibitors.
A “Review of the Toxicological Literature on Sodium Hexafluorosilicic Acid and Fluorosilicic Acid” 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; radioactive beams travel through the body, but no radioactive material is inserted into 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 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 four times as much fluids relative to their body weight as do adults. Their kidneys are not mature 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.
In 2006 the ADA issued an advisory that fluoridated water not be used to hydrate infant formula. However, the ADA weakened its advisory to one suggesting that notice should be given regarding the potential for dental fluorosis.
CDC, ADA, AMA, the surgeon general, and others have advised that if formula is mixed using fluoridated water that it will cause dental fluorosis. But the poor cannot afford to buy and haul fluoride-free water home or buy and maintain an expensive filtration system.
Fluoride is added allegedly to reduce caries, however, documents posted on the CDC website claim only an 18-25% reduction in caries. An 18-25% reduction means that fluoridation is 75 to 82% ineffective. Fluoridation involves a lot of risk for little positive return. And there are methods of reducing caries which are much more effective and involve no risk: Quit eating and drinking sugary junk foods. Eat vegetables rich in minerals instead. Floss, brush frequently, brush with toothpaste containing calcium and phosphorus, brush with baking soda, and brush occasionally with a drop of Lugol’s iodine – which kills streptococcus mutans very effectively.
Fluoridation is presented as the only way to reduce tooth decay, but instead it is a distraction from other and better ways to accomplish that.
Moreover, common comparison show no reduction. Tooth decay has dropped just as much in non-fluoridated Europe as in fluoridated United States, so fluoridation cannot be the causal factor. The only thorough studies of the effectiveness of fluoridation, including the Iowa study show no reduction in caries in fluoridated communities. The reputable Cochrane Collaboration has concluded that there are no well designed studies which show any caries diminution in carries in fluoridated over non-fluoridated communities.
Documents posted on the CDC website admit that the effect of fluoride on teeth is primarily topical 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, while 8.6% of these 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). Moderate and severe fluorosis can be ugly.
The basic math of fluoridation makes no sense: For an 18 to 25% alleged reduction in caries, we give 41% of teenagers some degree of dental fluorosis and give 3.6% of teenagers ugly and embarrassing moderate to severe fluorosis. Fluorosis should not be forced on people just so tooth decay can allegedly be reduced and at best reduced only slightly.
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Why do people believe so stubbornly in fluoridation? 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, they are lampooned as heretics and irrational conspiracy theorists. People wonder how fluoridation – if it is so harmful – could have arisen and why – if it is so harmful – how our regulatory agencies could allow it to continue. So I will now recount the amazing tale of how it came to be that we would add dilute poisons to our drinking water.
This is an important point to address because believing in fluoridation is being stuck in a thought maze and being unable to find the way out. It is like a cult religion in that regard. To escape a maze, it is helpful to know how the maze is constructed.
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, referred to as “Colorado brown stain”.
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.
The fluoride in Colorado Springs was naturally occurring calcium fluoride, which is less harmful and not even classed as an outright poison. Calcium fluoride comes with its own calcium and most well and spring water are rich in free calcium and magnesium, which keep the fluoride ions “occupied”, and so the fluoride is less likely to attach to the calcium and magnesium in our bones and other calcium rich organs. Naturally occurring fluoride is not harmless. Because it dissolves only up to around 8 ppm, it is not immediately poisonous as are man-made fluorides, which in the case of fluorosilicic acid will dissolve up to 26% or 260,000 ppm.
According to Dr. Richard Sauerheber, it is not fluoride per se we should worry about so much as the ratio between fluoride and positively charged minerals such as calcium and magnesium. Some hard water drinking wells can contain 300 ppm calcium and magnesium. Seattle and Everett water is primarily snowmelt water and is alkaline or “soft” and almost completely free of minerals. Dr. Sauerheber speculates that it was not the fluoride which prevented tooth decay in Colorado but the high mineral levels. Tooth decay was low in spite of fluoride, not because of fluoride.
Apparently it was when Dr. McKay met ALCOA profiteers in Arkansas, 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 fill that alleged need. Companies such as ALCOA had excess sodium fluoride to sell. Unfortunately, ideas get started, and if they are profitable, they develop a life of their own and persist even if they are completely unfounded, much like what happened with tetraethyl lead.
From the beginning ALCOA was at the center of efforts to add sodium fluoride 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 used to fluoridate. ALCOA wanted to sell the type of fluoride it had in excess, the cheaper and more toxic sodium fluoride.
Quoting from Fluoride Alert on How Industry Influenced EPA’s Fluoride Safety Standards:
“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”. 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, with its concomitant public disinformation campaigns. It also saw a federal blitz campaign to convince the public fluoride was safe and good for them. …
“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, 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. (See G.L. Waldbott, et al, Fluoridation: The Great Dilemma (Lawrence, Kans.: Coronado Press. 1978), pp. 304-05, and F.B. Exner, Economic Motives Behind Fluoridation (monograph) (Toronto: Westlake Press, 1966), pp. 1-2.)
“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.
ALCOA hired Robert Kehoe, a rising star chemist with the Kettering Institute to give fluoride a shiny new patina. ALCOA financed the Kettering Institute, and ALCOA people ran the Kettering Institute. Thus it was that ALCOA became the first company to sell fluoride as a water additive.
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Kehoe and Kettering should not have been trusted. Before the Kettering Institute promoted fluoridation, it promoted tetraethyl lead. 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. It is even more relevant because fluorosilicic acid contains lead and leaches lead from plumbing.
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. Lead lubricates and “heals” metals. It works well in high compression piston engines. It is still unfortunately used in the form of leaded Avgas in some piston aircraft and in a few backward countries in trucks and cars. Unfortunately, tetraethyl lead was also very poisonous, and several of its inventors and promoters died of lead poisoning. Nevertheless, 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.
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…
“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. …
“From around 1923 until tetraethyl lead was phased out starting in 1973, everyone in congested streets was poisoned by tetraethyl lead. 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 digression 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 now the way your grandparents were lied to about tetraethyl lead.
The point is that we should quit being naïve. What I refer to as “Matrix corporations” will poison their own children to maximize profits.
And what is a Matrix corporation? One which has no code of ethics other than profit maximization and which has manipulated its articles of incorporation and its bylaws to imbed profit maximization as a corporation’s primary and only value. One way to do this would be to imbed in corporate bylaws a policy that any executive who fails for any reason to maintain and increase profits will be fired. Dismissal would be automatic. This is how Matrix corporations come to be.
Matrix corporations 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 who will regard 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 leaving a Matrix corporation to working for a government agency, and they will get huge bonuses when they return to the Matrix corporation.. Colleges end up being captured by the industries which donate to them, and legislators and 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.
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ALCOA had an ally, the Public Health Service, at that time a branch of the military. When drinking water fluoridation began in 1945, it was pushed by the Public Health Service and later by state dental directors. Major ALCOA shareholder Andrew Mellon was head of the Public Health Service at that time.
The Atomic Energy Commission and the Manhattan Project 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 were being sued. They were using fluoride to dissolve metals. Their factories belched out fluoride fumes that formed a downwind toxic cloud, and they had waste fluoride left over. Farmers sued for damage to everything from peaches to cattle. 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.
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 their melting point. Without fluoride it would be impossible to “crack” petroleum and produce gasoline.
Chemical companies organized the “Fluorine Lawyers”, a platoon of defense attorneys who were ready at a moment’s notice to defend when anyone dared file a claim against the government or private industry for harm caused by “fluorine”. The Fluorine Lawyers had their expert witnesses lined up. They had pocket briefs at the ready covering every possible issue which might arise. They pounded inexperienced, local 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. Whether approval was sought is not known. 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 that would help defeat the Germans and Japanese and later to intimidate the USSR. The Manhattan Project also administered plutonium 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, 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 19th 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.
By the early 1950s, fluoridation was declared a success, before comparative studies at Grand Rapids, Newburg, and Brantford had been completed. Results which called fluoride safety into question were ignored or suppressed. 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 in 1945. 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 Stat. 648) for the first time explicitly defined two classes of medications (prescription and over-the-counter, OTC. (See Christopher v. SmithKline Beecham Corp., 635 F.3d 383, 385 (9th Cir. 2011). 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, although the OTC language was not used. The FDC ruled “fluorine” added to water or food as “not actionable”. The FDA adopted the following regulation in 1952:
[Title:] Status of fluoridated water and foods prepared with fluoridated water under the Federal Food, Drug, and Cosmetic Act:
“(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. Nevertheless, a substantial number of inquiries have been received concerning the status of such water under the provision of the act and the status in interstate commerce of commercially prepared foods in which fluoridated water has been used.
“(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. Similarly, commercially prepared foods within the jurisdiction of the act, in which a fluoridated water supply has been used in the processing operation, will not be regarded as actionable under Federal law because of the fluorine content of the water so used unless the process involves a significant concentration of fluorine from the water. … Former 21 CFR 3.27 (1952); 17 FR 6732.
Note that although the regulation is entitled “Status of fluoridated water and foods prepared with fluoridated water under the Federal Food, Drug, and Cosmetic Act”, this regulation reads as if it were proposed and enacted by the Federal Security Agency and the Public Health Service and not by the FDA.
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Note again that 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).
Note the emphasis on intended use. The issue is not whether the drug actually cures or prevents harm. The issue is whether vendors of the drug claim it will do these things. Dental caries is a disease, and fluoride is added to water to prevent caries. The vendors claim fluoride prevents tooth decay and strengthens teeth, and thus it is a drug. For example, the 2008 Fact Sheet on Fluoridation Chemicals says:
“Water fluoridation is the practice of adjusting the fluoride content of drinking water. Fluoride is added to water for the public health benefit of preventing and reducing tooth decay and improving the health of the community.
The American Dental Association says:
More than 70 years of scientific research has consistently shown that an optimal level of fluoride in community water is safe and effective in preventing tooth decay by at least 25% in both children and adults.
The Centers for Disease Control says:
Fluoride benefits children and adults throughout their lives. For children younger than age 8, fluoride helps strengthen the adult (permanent) teeth that are developing under the gums. For adults, drinking water with fluoride supports tooth enamel, keeping teeth strong and healthy.
Because fluoride and fluoridated water meet the definition of a drug and are sold as having the characteristics of a drug, the US Food and Drug Administration (FDA) should have retained and asserted its jurisdiction over fluoride added to drinking water and should assert its jurisdiction now.
However, the FDA chose to back down to the Public Health Service, to classify fluoridation in 1952 as “not actionable”, and not to assert jurisdiction over fluoridation, nor over fluoridation materials and 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. Fluoridated bottled water is a bad thing, but not nearly as bad as fluoridated tap water. One can avoid fluoridated bottled water to a limited extent by not buying it, although fluoride content is only noted on the bottle if fluoride is added, so if bottled water is made from fluoridated tap water, its fluoride content will not appear on the label. One can avoid exposure to fluoride in tap water only by removing it at great effort and expense.
Although the FDA has jurisdiction over the fluoride tap water drug, it has not exercised that jurisdiction. FDA has jurisdiction to disapprove fluoridation or to approve it – if it found fluoridation to be both safe and effective. The EPA has jurisdiction over fluoride to disapprove fluoridation but not to approve it. EPA did not approve or disapprove fluoridation but shuffled the issue off to NSF, which approved it as “safe”, although NSF says nothing about whether fluoridation is effective. The FDA would never approve a drug which is safe but not effective, because drugs always pose some risk of side effects for certain populations.
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. For drugs with approved NDAs under the 1938 Act to retain their NDAs, producers were required to demonstrate they were effective. (Weinberger v. Hynson, Wescott & Dunning, Inc., 412 U.S. 609, 612-615, (1973).
In 1972 the FDA established a new approval process for nonprescription drugs. 21 CFR Part 330. 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. In 1995 the OTC rule was finalized and applied strictly to anticaries drugs, as discussed below. *
The Safe Drinking Water Act (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 fluoridation:
“No national primary drinking water regulation may require the addition 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 was to forbid adding medicines to drinking water. Unfortunately, this law was badly worded. It only forbids enacting a national regulation which would require adding medicines. It does not forbid actually adding them. As long as CDC, EPA, or other agency merely recommends fluoridation and leaves it up to the water districts to require it, the EPA would appear to have wide latitude to promote fluoridation.
However, my opinion as a lawyer is that EPA, CDC, NSF, local water districts, and the fluoride producers and resellers, all acting together, have implemented a de facto national drinking water regulation which requires fluoridation for 70% of the residents of our 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 in drinking water, whether naturally occurring or from pollution, is above the MCL, action must be taken to remove it. As I will document below, the MCLs were not authorizations to add elements or compounds up to the MCL limit but to require removal of contaminants if they were higher than the MCL level.
An MCL should be set as closely as possible to the MCLG, taking technology and costs into account. 42 USC 300(g) 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) for fluoride. 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”. 42 USC 300(g) 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. [emphasis added]
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 CDC admits that 41% of children 12-15 are developing dental fluorosis at the 1.0 ppm level. The MCLG goal should be zero, as it is for arsenic and lead.
The EPA also established a secondary MCL 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.
However, like the primary MCL, the secondary MCL of 2 ppm does not authorize adding fluoride up to 2 ppm or the addition of any amount of fluoride to drinking water. It only requires that when natural fluoride levels are at 2 ppm or higher or when pollution raises fluoride levels that high that notice be published warning users that fluorosis may result. The very existence of a secondary MCL to prevent fluorosis is an admission that fluoride causes harm.
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The SDWA was enacted in 1974. In 1979 the FDA and the EPA entered into an inter-agency treaty, a Memorandum of Understanding, numbered MOU 225-79-2001, This Memorandum included these provisions:
“[T]he 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 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).
Although the Memorandum did not specifically mention fluoride, it did not mention other items added and would have covered fluoride. Attorney Gerald Steel argues that the FDA never intended to relinquish authority over adding fluoride used for drug or medical purposes, however, the plain wording of the Memorandum can be read to say and was probably interpreted by most to say otherwise. The deeper question is whether the FDA had the authority to relinquish authority over a drug regarding which the FDA Act makes the FDA responsible. In this case it is fluoride, which is a drug, and which therefore must remain under FDA jurisdiction, and for this reason Attorney Steel is probably correct. The FDA assignment under the MOU was therefore ineffective.
Only Congress can change a federal statute. Agencies cannot cede their authority to each other, which is clearly what the FDA and EPA were trying to do regarding fluoride.
Even if the FDA did have power to assign to the EPA the authority to approve and regulate fluoridation, a regulatory task which Congress gave to FDA, the EPA was barred from receiving that power or filling that role, because 42 USC 300g-1(b), apparently part of the original 1974 version of the SDWA, specifically forbids the EPA from enacting any national primary drinking water regulation which would require fluoridation:
“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 net result was that the FDA was unwilling either to authorize and regulate or ban water fluoridation, apparently because fluoride was a political hot potato, and the EPA was legally barred authorizing or regulating water fluoridation, although the 1979 Memorandum of Understanding 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. The EPA does have authority to ban drinking water fluoridation, and it should. However, the EPA has no authority to authorize fluoridation or pass regulations on how or at what level fluoridation should be done because such authorization or regulation invites states and local water districts to require fluoridation and thus can be part of a “national primary drinking water regulation”. Nor does the CDC. I will go into this issue in greater detail below.
There are two ways to interpret the SWDA provision at 42 USC 300g-1(b)(11). 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, and it did not say this.
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 it, provided that local water districts make the final choice to require and implement fluoridation. However, this interpretation would be contrary to the “restore and maintain the chemical, physical, and biological integrity of the Nation’s waters” language of the SDWA prologue:
“(3) it is the national policy that the discharge of toxic pollutants in toxic amounts be prohibited; …
(6) it is the national policy that a major research and demonstration effort be made to develop technology necessary to eliminate the discharge of pollutants into the navigable waters, waters of the contiguous zone, and the oceans.
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 in favor of the chemical industry. Ann Gorsuch and her 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. 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. Bill Hirzy spoke for the Union.
Presumably, because of the 1974 restriction, EPA administrators were wary of approving and certifying fluoridation materials. Presumably EPA scientists were unwilling to cooperate with such a scheme, and without the assistance of the scientists, EPA administrators could not proceed. Apparently, administrators decided that the next best thing would be to appoint some other group to approve and certify fluoridation materials for use.
Government was the problem according to Reagan, and privatization was the solution to almost everything. Thus, the EPA came up with the idea of privatization of the regulation of fluoridation. In 1985 the EPA began funding and training NSF to certify fluoride as safe (although NSF did not and does not certify it to be 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 to NSF, nor did it have power to assign such powers to NSF.
By 1988, the work was done. The EPA had turned over authority to NSF to approve fluoridation materials 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 ….
Tudor Davies, former director of the EPA Office of Science and Technology, in his April 2, 1998, letter 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 one point. There are no Federal safety which would empower the EPA to authorize or require the addition of fluoride to drinking. There are, however, safety standards which would allow and even require the EPA to ban fluoridation. So too could the FDA.
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. The Termination mentioned the 1979 Memorandum of Understanding 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 1988 Termination did not elaborate on the 1979 transfer of fluoridation authority from the FDA 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 (53 FR 42776). 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 the Dietary Supplement Health and Education Act (DSHEA), which amended the FDCA Act of 1938. The DSHEA contains explicit statutory language that classifies minerals as dietary supplements. Fluoride of course is a mineral and therefore is a dietary supplement under DSHEA. 21 USC 321(f)(1)(B). Minerals are normally regulated as foods except when they are drugs.
The DSHEA made it clear that minerals including fluoride are drugs if their intended use is to prevent disease. According to Alliance for Natural Health, US vs., Sibelius, 714 F.Supp. 2d, 48,50 (DDC 2010):
“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.”
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, 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 falls 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. Fluoridation got a pass from the FDA in 1952 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.
As mentioned above, in 1972, the FDA established a new approval process for nonprescription drugs. 21 CFR 330. 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.) FDA maintains a list of OTC active ingredients and related monographs. The anticaries monograph, found at 21 CFR 355, 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 medical doctors were handing out prescriptions to water districts for adding fluoride to tap water, 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? 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, and for two reasons. First, fluoridation materials are sold in bulk, and OTC drugs cannot be sold in bulk. Second, fluoridation materials are not pharmaceutical grade, which OTC drugs must be.
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 and with anticaries monograph conditions in 21 CFR 355. Otherwise a NDA or AND is required.
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In 1996, the FDA determined that its 1952 regulation, reworded and found at 21 CFR 250.203 was obsolete or no longer necessary, and the FDA revoked it. 61 FR 29476. FDA was announcing that it was revoking its old commitment to the Public Health Service and the that adding fluoride to drinking water was no longer not actionable.
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.
The purpose of the 1979 Memorandum of Understanding between FDA and EPA was to have the EPA operate is federal drinking water additives program. 44 FR 42775-78. EPA’s announcement in 1988 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 did, although apparently without giving formal notice to the FDA.
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In 1996 the FDA prepared a list of chemicals which included hydrogen fluoride used as an anti-caries agent. Regarding this list 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.
Thus any anticaries drug that includes hydrogen fluoride requires an NDA (New Drug Approval) before it can be sold. See 21 CFR 310.545. This regulation is unenforced, overlooked, or ignored, like so many laws which touch on fluoridation. If it were enforced it would result in a ban of water fluoridation with fluorosilicic acid or sodium silicofluoride because they contain around 1.5% hydrogen fluoride. The same could be said of sodium fluoride, which does not contains HF but which breaks down in acid conditions, such as in the stomach, where it readily forms HF. Regardless of whether fluoridation is done with fluorosilicic acid, sodium silicofluoride, or sodium fluoride, at 1-3 pH, which is the acidity in the stomach when a meal is eaten, half the fluoride ion present binds ionically with hydrogen, forming the penetrating and poisonous hydrogen fluoride.
Based on this law it is illegal to fluoridate. An activist or perhaps the state attorney general or county or city attorneys could sue for a restraining order against fluoridation using this regulation. Section 1449 of the SDWA authorizes a private citizen to enforce the terms of the SDWA.
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In 1997 FDA proposed 21 CFR 356 as a new regulation, which was later approved. (60 FR 52474; 61 FR 52285) 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. [NDA or ANDA]
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 for those dispensed by prescription, such as Luride. Fluoridation materials meet the definition of drugs and therefore must be either prescription drugs or OTC drugs. Either way they should have prior FDA approval.
Luride is a fluoride tablet 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 may be swallowed but they are distributed only through health professionals.
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In 2000 Congress held hearings on drinking water fluoridation, 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 ban fluoridation. Congress did no such thing. Such was the power of the Matrix fertilizer and chemical corporations 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:
“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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Likewise, fluoridation critics thought that the 2006 National Research Council Report, Fluoride in Drinking Water would be 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 fluoridation opponents thought policy makers would come to their senses and stop the practice. It has now been nine years since the 2006 NRC Report was released, and nothing has changed. Such is the power of the fluoride lobby.
The EPA is required by law to commission the NRC to review its work periodically, and so the EPA commissions reports on fluoride. Reports were released in 1993 and 2006. However, the EPA told the NRC to avoid the subject of drinking water fluoridation. This is what NRC said regarding the EPA’s limitations on the scope of its assignment:
“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.
EPA limited the scope of the 2006 Report at the same time as the EPA and the CDC were endorsing 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.
Why would the EPA tell the NRC to avoid the subject of artificial fluoridation? Probably because the EPA did not want the truth about fluoridation materials to be disclosed.
On the one hand, the EPA was telling the NRC not to research or report on drinking water fluoridation. On the other hand the CDC and EPA were promoting fluoridation. And worse, the CDC and EPA have made claims that the fact that the NRC did not directly address fluoridation in its 2006 Report serves as evidence that the NRC approved fluoridation.
In the 2006 NRC Report the NRC told the EPA that the 4 ppm MCL action level for fluoride should be lowered – and it was referring to naturally occurring fluoride. 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 lower 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 regarding fluoride, in part repeating issues mentioned in the 1993 report:
“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, pages 6-9.
However, the EPA and HHS have failed to do their homework, both following the 1993 and the 2006 Reports. They ignored all the questions NRC posed and wrote and research instead exclusively about fluorosis and caries reduction. They posted poorly designed studies on their web sites which showed that fluoride results typically in an 18% to 25% reduction in caries.
Has fluoridation reduced tooth decay? Tooth decay has dropped just as much in non-fluoridated continental Europe. The large and well-designed Iowa study showed no reduction in caries in fluoridated communities. The new Cochrane analysis of fluoridation studies says there are no well done studies which find that fluoridation reduces caries, but it found that fluoridation increases dental fluorosis of aesthetic concern by 12%.
EPA and HHS openly admit that fluoridation causes harm. They even pointed to the Beltrane study which shows that 41% of children age 12-15 are getting fluorosis. 8.6% of said 41% suffer from mild 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 up to 100% of enamel impacted). Mild and especially moderate and server fluorosis can be ugly and embarrassing. (8.6% + 3.6% = 12.2%, the figure referred to in the Cochrane analysis.)
Most of the fluoride we consume comes from drinking water. NRC 2006 Report, page 60 in the online Report.
Further EPA and HHS pointed to the CDC study which found that the effect of fluoride is primary topical and not systemic.
Relying only on sources and studies brought forth by CDC and EPA, and not even relying on studies done by others, fluoridation makes no sense. It offers only at most 25% reduction in carries – when in fact there is probably little or no reduction – but we must pay the price of having 41% of teens get some degree of fluorosis. Why should we knowingly cause any level of fluorosis? When there is dental fluorosis, there is fluorosis of every bone in the body and fluorosis of calcium rich organs such as the pineal, the master gland.
The EPA and HHS were in effect admitting that their position was wrong, that fluoridation reduced decay only 18 to 25%, was relatively ineffective and worked primarily topically and not systemically, and caused fluorosis. But they were still supporting only a reduction in fluoridation level to .7 ppm and not a complete termination of fluoridation. Even a lawyer can see that this makes no sense.
In 2006 the NRC said the 4 ppm MCL was too high and asked EPA to study the issue and recommend a lower MCL, which means the level above which naturally occurring fluoride or fluoride from pollution must be removed from drinking water. The EPA has not done this. Instead the EPA and CDC have only proposed a lower level at which artificial fluoride can be added to drinking water. Essentially, the EPA and CDC ignored the NRC.
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In 1988 the EPA said that it was getting out of the water additives business, but it didn’t. It is still promoting fluoridation – with NSF acting as its proxy. EPA continues to operate its Environmental Technology Versification Program (ETV) for drinking water systems, a program “managed” by NSF.
To this day, the CDC and the EPA continue with their behind-the-scenes, indirect, and unauthorized authorization, promotion, and financing of drinking water fluoridation. Their behavior is analogous to Oliver North running the Contra War out of the Whitehouse basement.
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In 2011 HHS and EPA jointly issued a 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 slightly instead of eliminated entirely. Many of the case studies cited by HHS and EPA describe serious dental fluorosis and do not support fluoridation.
In my Fluoride Report Card for HHS and EPA I made a long list of the illogical and inconsistent nature of the joint proposals coming from HHS and EPA. I sent a second letter at the same time regarding the lead in fluoridation materials and the leaching of lead from plumbing by fluoridation materials.
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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? NSF? 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 by turning over regulation to a trade association, one which is subject to undue influence by the chemical industry it regulates? Is it acceptable that federal agencies such as CDC maintain a fluoridation engineering department and that EPA finances and directs NSF to operate as a sham FDA?
The Centers for Disease Control (CDC) is the biggest cheer leader for drinking water fluoridation. The EPA is also a defender of fluoridation. 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 a branch of the military when World War II ended. In 19__ 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, including efforts to propagandize the benefits of fluoridation.
As mentioned previously, the CDC has its own fluoride engineering department which assists states and water districts in getting the laws passed to require fluoridation anywhere possible. As late as 2010 when I last talked with chief fluoridation engineer Kip Dujon, the CDC still had fluoridation engineers on staff. Kip’s phone number is 770-488-6054. Why does the CDC even have a “chief fluoridation engineer”?
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 who counsel politicians in how to pass mandatory fluoridation laws.
Such behavior on the part of the CDC makes it a member of a multi-party conspiracy 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.” 42 USC 300g-1(b)(11)
The current Surgeon General, David Satcher, is a true believer when it comes to fluoridation. Read his report on Oral Health, pages 158 – 169, and you will find a collection of nonsensical, outdated, incomplete, and incorrect babblings about fluoridation. I know of not one single surgeon general who opposed water fluoridation. It would seem to be a prerequisite for getting the job. 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 to NSF the authority which EPA had allegedly received from FDA under the 1979 Memorandum. But the EPA as well has no legal authority to authorize, regulate, or approve water fluoridation. Yet EPA still reviews, certifies, and finances the work of the NSF, including the NSF Rule 60 Standard book on drinking water fluoridation.
The EPA cannot legally authorize or require fluoridation, but it could ban it, as could the FDA. The EPA bans many chemicals. See, for example its banned pesticides list. Under the Toxic Substances Control Act the EPA has powers to ban chemicals:
“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.
EPA scientists have long opposed fluoridation, 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, starting with Ann Gorsuch under Ronald Reagan, and the pro-consumer party, which is made up of EPA scientists.
Agency heads often have worked for and taken money from the big chemical corporations which the EPA regulates. It is called the revolving door. Michael Taylor, former Monsanto man, is now FDA’s Deputy Commissioner for Foods, which approves GMO foods. The FDA, at least on the administrative level, has been taken over by the industries it regulates. The system has been corrupted by money. The same can be said of the EPA and CDC. If you are a Matrix corporation and you want to sell fluoride, the best way to do that is to control the agencies which promote it.
The Safe Drinking Water Act (SDWA) is administered by and regulates the actions of the EPA in connection with drinking water. Note again that the SDWA specifically states at 42 USC 300g-1(b)(11):
“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 an authorization to add fluoride up to the 4 ppm MCL. The EPA may require or authorize the addition of substances to water, but only those which remove or neutralize contaminants, such as chlorine used to kill bacteria or alum used as a flocculant to precipitate and remove dirt.
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, 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 .7 ppm meets federal definitions of “drug” and “medication.” It would also meet state definitions. See Washington WAC 246-290-220 and Oregon regulation OAR 333-061-0005. 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 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, 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. The 15 ppb and 10 ppb MCLs are not authorizations 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 goal is a statement that no lead or arsenic should be added; if the goal is zero, one does not get closer to that goal by adding any lead or arsenic. Fluoridation materials contain lead and arsenic. The EPA may not authorize the addition of lead or arsenic to drinking water, however, the NSF does just that, because fluoridation materials contain lead and arsenic. NSF claims to have received authority to do so from the EPA and claims that the EPA is in continual approval of its work. Thus, working indirectly through its proxy, the EPA authorizes adding lead and arsenic to our water.
The February 2008 NSF Fact Sheet on Fluoridation Chemicals, 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. Everett does the same. Don’t forget that silicofluoride not only contains lead but also leaches lead from pipes and fittings.
In 2012 and 2013 NSF issued its 2012 NSF Fact Sheet and 2013 NSF Fluoride Fact Sheet on fluoridation, updating its 2008 NSF Fact sheet on fluoridation. 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, 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.
The MCLG, the maximum contaminant level goal, for arsenic and lead are both zero. See 40 CFR 141.51. 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 whatsoever.
Fluoride is a little more toxic than lead, a little less toxic than arsenic. See Clinical Toxicology of Consumer Products, LD 50. The MCL for lead is 15 ppb; the MCL for arsenic is 10 ppb; but the MCL for fluoride is 4.0 ppm, that is 4,000 ppb. The reason why the body can cope with fluoride up to a certain point is that the body sequesters the fluoride in the bones and teeth and other calcium rich areas. But the bones can only hold so much, and then fluoride begins to impact other organs more heavily.
The EPA or FDA could not authorize or require the addition of lead or arsenic to drinking water in any amount, but the EPA does so through its proxy NSF. Obviously, this is a consumer protection scam. NSF and the suppliers scam the water districts and the water drinkers to by their toxic waste.
There are several really amazing things about the fluoridation story. It is amazing that it is so hard to convince those in power and the public in general that fluoridation is relatively or completely ineffective, harmful, and illegal. It is amazing how gullible and trusting people are of their agencies. Our agencies cannot be trusted. They are wholly owned subsidiaries of mega Matrix corporations.
I have proposed a solution to this problem: Enact state and federal laws which require corporations above a certain size to post their codes of ethics. Consumers and investors would then vote with their dollars, deciding whether to buy stock in a corporation and whether to buy its products.
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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 do so.
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,” state regulations likewise must be so limited. Therefore state regulatory agencies may not enact regulations which require municipalities add fluoride or any other medication intended for “preventive health care purposes.” State mandatory fluoridation laws violate the Safe Drinking Water Act.
In each state there is a lead agency which is empowered to administer the SDWA. 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 Washington, for example, the lead agency is the Department of Health. RCW 70.119A.080, RCW 43.21A.445. According to RCW 43.21A.445 several Washington agencies led by the Department of Health are “… authorized to participate fully in and are empowered to administer …” the SDWA.
Like the EPA, the Washington Department of Health 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.” Technically, the Washington 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. It also says that any fluoridation materials used must “comply with” NSF Rule 60 Standard.
However, California, Arkansas, and many other states have enacted mandatory fluoridation laws. This is clearly forbidden by the SDWA, and I am surprised that state mandatory fluoridation laws have not been challenged in court.
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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” flows down to the states. Does it flow down even further to water districts? The answer is yes. 40 CFR 142.3 and 142.30 provide:
“… [T]his part [40 CFR Part 142—National Primary Drinking Water Regulations Implementation] applies to each public water system in each State. … The Administrator shall notify a State and the appropriate supplier of water whenever he finds during a period in which the State has primary enforcement responsibility for public water systems that a public water system within such State is not in compliance with any primary drinking water regulation contained in part 141 of this chapter. …
40 CFR 142.2 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 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,” to drinking water, namely fluoride. Because the limitations imposed by the SDWA do flow down to municipalities, 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 individual municipality which assumes the liability of requiring fluoridation. The water district makes its decision based on the false assurances of the sham NSF regulatory agency that fluoridation materials are safe, backed up by coordinated propaganda from the CDC.
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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:
“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” arguably is the equivalent of a regulation. The NSF Rule 60 Standard is recognized by law as authorizing the use of fluoridation materials which meet its standard. It is therefore a “national primary drinking water regulation” under 42 USC 300g-1(b)(11).
The “NSF 60” logo is stamped on every fluoride shipment bill of lading. The Hazen letter 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]….
Another amazing thing about the fluoridation story: The industries which produce fluoridation materials acid are all explicitly allowed to sit on the board which develops the standards which in turn regulate fluoridation materials.
The NSF Rule 60 Standard says without equivocation that toxicological studies will be done, as do the 2013 NSF Fluoride Fact Sheet, the 2012 NSF Fluoride Fact Sheet, and the 2008 NSF Fact Sheet on Fluoridation Chemicals, the latter saying:
“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 providing toxicological services, having toxicologists on staff, and having an NSF International’s Toxicology and Risk Assessment department.
NSF has this to say about the “NSF Mark”, which appears on bills of lading:
“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 introduced some doubt as to whether toxicological studies have been done:
“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, 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.
Second, if you call NSF and ask if they have toxicological studies, they will tell you the truth and say no. You can call Blake Stark, NSF official in charge of fielding questions regarding NSF Rule 60. Call Blake at 734-769-5480 or email him at Stark@NSF.org and ask him if there are any toxicological studies. Blake will tell you what he told me, that there are no toxicological studies. See this response and this response from NSF’s NSF’s Blake Stark in response to my request to him for toxicological studies.
Third, NSF official, Stan Hazen, admitted under oath that toxicological studies were not done or available. See a transcript of a California deposition (page 67) in which Hazan said:
“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.
In plain words, Hazan was saying that NSF does not do toxicological studies or receive toxicological studies from the suppliers. Instead, it improvises toxicological data. It refers to the MCL for fluoride and for all the other contaminants it comes with, and as long as the concentration of the contaminants is below the MCL, the toxicological studies are waived and the NSF Rule 60 requirement is considered fulfilled.
Fourth, there are no universities known to be working for NSF or the chemical companies which sell fluorosilicic acid which have done toxicological studies. If there were, you would be reading about them in PubMed. If any toxicological studies have been done by private laboratories, it is a well kept secret.
Fifth, numerous water districts have written to suppliers of fluoridation materials asking them for their toxicological studies, and not one supplier has ever produced a single study. In some cases the suppliers stop selling fluoridation materials to those water districts which have requested studies.
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NSF does some testing, apparently analyses of samples of fluoridation materials shipped in from suppliers for tested. NSF does such random testing only rarely. On April 24, 2000, NSF responded to the State of Florida Department of Public Health 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, as Dr. Bill Osmunson suggests in his article on batch testing. 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 the contents of any tanker load arriving at Seattle or Everett has been tested is the inverse of .162%, meaning that only around one in every 617 tanker loads is batch tested. Everett receives 18 tanker loads per year, so the fluoridation materials delivered to Everett might be tested only once every 34 years.
Further, there is nothing to stop the chemical companies from selecting batches to be tested and nothing to stop them from not stirring the brew and taking samples off the top of the mixture, so that more of the heavy metals will have sunk to the bottom, thus showing a lower concentration of the worst contaminants.
George Glasser, environmental journalist, says that silicofluoride is radioactive, containing uranium, radium, and polonium, as well as other hazardous elements and chemicals.
Another amazing thing about the fluoridation story: 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 certification 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 too embarrassing to reveal, and in any case, even if done, is not available for review.
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NSF took over fluoride regulation from the EPA, but NSF Rule 60 Standard is a private document. To read it you must pay $325. Everett Utilities does not even posses a copy of the NSF Rule 60 Standard book. Nevertheless, WAC 246-290-220(3) requires Washington water districts to use only materials which “comply” with NSF Rule 60 Standards. Hazen brags that some 43 (later 47) states and nine provinces have similar laws.
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 the NSF 60 Rule Standard with 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.
Another *amazing thing about the fluoridation story is that the FDA has put up with NSF impersonating it for so many years.
Note that, according to Hazen, 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 indication that he is talking about adding fluoride and doing so based on a maximum amount added of 4 ppm, which is the EPA MCL. However, the MCL is the level above which removal is required, not the level up to which fluoride may be added. 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.
Another amazing thing about the fluoridation story: Apparently the people running NSF do not understand basic science and do not comprehend that they are engaged in a civil and probably also a criminal conspiracy.
I have written both to NSF and to Simplot, which supplies fluoridation materials to Seattle and Everett, putting them both on notice that they are violating the law and are liable. Neither has responded.
“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.
Given that the EPA MCL for fluoride is 4 ppm, NSF should have set a.4 ppm MAL, maximum allowable level (the equivalent of MCL or maximum contaminant level). NSF did that for all the contaminants except fluoride. The NSF Rule 60 Standard book says that the MAL will be set at one-tenth of the FDA MCL, but NSF instead set the MAL for fluoride at a maximum of 1.2 ppm, which is three-tenths of the MCL. Again, the NSF fails to “comply with” its own rules, another reason why drinking water fluoridation with such fluoridation materials is illegal under the law of most states and provinces. *
NSF justifies its action 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 new .7 ppm maximum for fluoride added to drinking water is around one-sixth of the MCL (.7/4.0), which still exceeds the one-tenth standard in the NSF Rule 60 Standard book.
The justification given for violating the one-tenth rule 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 sulfuryl fluoride, and toothpaste swallowed and absorbed through mouth tissues by all. The Environmental Working Group notes, for example, that the EPA allows up to 900 ppm fluoride in dried eggs. One-third of all eggs are dried and then added to a wide range of food products.
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 to kill weevils, and the fluoridated grain is fed to the chickens. Another factor is that the dried eggs themselves are fumigated for long term storage with sulfuryl fluoride. 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. Fortunately, the EPA may be 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 first response to this weevil business is that grain storage facilities should be upgraded and kept clean so that pests have a harder time infesting the grain. My second response is that we should be less concerned about eating a few weevils in our bread or cakes. Although I am a strict vegan, I would rather eat a little organic weevils than sulfuryl fluoride. Weevils are a good source of protein and omega-3 fatty acids. If weevils infest certified organic wheat, they can be sold as a certified organic mixture of wheat and meat. There might be a market for weevil infested organic wheat. Even under current standards, wheat flour, for example, is already allowed to contain up to 150 insect fragments per 100 grams. If that allowable levels of insect parts, including whole weevils, were raised, we could quit using fumigants. Sulfuryl fluoride is convenient for the middle-men who sell commodities, but there are other ways to control insects, such as doing a better job of cleaning and sealing storage facilities. Complete weevil control is impossible and unnecessary. The sure way to be rid of insects in grains and flour is to freeze it. Diatomaceous earth is also highly effective against insects, and it is harmless to humans and animals. The advantage of sulfuryl fluoride is that it also kills rodents (and humans if they are in the sealed building or silo when grain is fumigated.
Aside: Wheat, barley, and similar grains should be sprouted before they are eaten. Their tough shell contains anti-nutrients to server as a barrier to insects, and these anti-nutrients are not easy for all to digest. Flour should be made of sprouted wheat.
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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. (emphasis added)
By 2010, some 47 states and nine provinces had similar laws. The states write their laws assuming that the NSF Rule 60 stamp of approval means that the procedures outlined in NSF Rule 60 have been followed. They read the NSF Rule 60 Standard and the Fact Sheet on the NSF.org web site and rely on its assertions of testing and safety. Likewise, water districts pass their fluoridation ordinances making the same assumptions. But NSF 60 is a sham law. NSF does not do the testing nor require suppliers to do the testing, and so has no basis for claiming that fluoridation materials are safe.
Another amazing thing about the fluoridation story: State regulations require that municipalities conform to an NSF certification which is a complete fraud.
Fluoridation materials in Washington, according to WAC 246-290-220(3), must “comply with” NSF Rule 60 Standards. Current fluoridation materials do not “comply with” NSF Rule 60 Standards. Note that Washington law does not state that it is sufficient that the fluoride bill of lading display the NSF 60 mark. The fluoride itself must “comply with” NSF 60. Therefore, it is illegal to use current fluoridation materials for drinking water fluoridation in Washington.
Everett, Seattle, Tacoma, Port Angeles, and most other large water districts which fluoridate use fluorosilicic acid as their fluoridation material. The 2008 NSF Fluoridation Fact Sheet discusses “fluorosilicic acid”, which is the same thing as “fluosilicic acid or “hexafluorosilicic acid”.
Port Angeles is typical. See the October 28, 2008, letter from Gregg Grunenfelder 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 said certification 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, the 2012 NSF Fluoridation Fact Sheet, and the 2013 NSF Fluoride Fact Sheet for any reference to the 2006 NRC Report. There is none. NSF standards are outdated. Water districts are relying on a fluoridation regulation which not only is a sham but also which is also an outdated sham.
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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.”
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 Sheets 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.
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This is a shell game, and this is how it 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 from 1952 until 1996 and waived its jurisdiction, giving fluoridation a “pass”, categorizing its use as “non-actionable”. In 1979 when the FDA entered into its Memorandum of Understanding with the new EPA, perhaps the FDA was assuming that EPA, as an independent agency, would do what FDA had been unable to do and ban fluoridation. Or maybe the FDA was just getting rid of a “hot potato”.
The EPA received alleged authorization from the FDA 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 received an alleged authorization that it could only exercise in one way only – to ban fluoridation, not to authorize it or to participate in a scheme the effect of which is to require it on state and local levels.
So during the Reagan administration pro-industry directors of EPA assigned power it did not have to NSF beginning in 1985. By 1988 the job was done and EPA had delegated authority to NSF to approve fluoridation materials and build up a de facto national regulatory scheme to encourage and approve (but not require) fluoridation at the national level and to enable states and water districts to require fluoridation at the state and city levels 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.) The Termination mentioned the 1979 Memorandum of Understanding 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 “comply with” the NSF Rule 60 Standard. By law water districts are required to conform to a sham regulation issued by a sham agency, NSF.
In my letter to the NSF I demanded that NSF immediately remove its certification of fluoridation materials under the NSF Rule 60 Standard. 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 Rule 60 Standard to enact laws requiring that only fluoridation materials which “comply with” the NSF Rule 60 Standard be utilized for fluoridation. Water districts in turn rely on the veracity of the NSF Rule 60 Standard to enact laws requiring fluoridation.
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We have looked at the EPA, the CDC, the NSF, city councils and water districts, and the states. It is also appropriate to look at the chemical, smelting, and fertilizer companies which produce and sell fluoridation materials. These companies worked side by side with the EPA to develop the NSF Rule 60 Standard. Stan Hazen, authorized spokesman for NSF has acknowledged that the NSF 60 drinking water standard
“was developed … with representation of the major stakeholder interests, including product manufacturers ….
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. Chemical, smelting, and fertilizer companies have waste sodium fluoride, fluorosilicic acid, and sodium silicofluoride to sell. Other chemical companies act as resellers or importers, buying from 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 sodium fluoride, fluorosilicic acid, and sodium silicofluoride be sold for other uses? What is the price the suppliers get for fluorosilicic acid when they sell it as a fluoridation material? What price do they get for it when they sell it for other purposes? Can they sell all of it for other purposes? If fluoridation were to stop 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 if it is not sold as fluoridation materials? What would be the cost of disposal?
Vast amounts of silicofluoride waste remains were disposed of onsite in Central Florida 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. Following the hurricanes, some of the Florida phosphate mines did not restart production and much of the silicofluoride is now being imported from China and Mexico where production costs are lower. Some of the storage ponds were so heavy that they collapsed the land below them, forming enormous sink holes the size of football fields. The filthy contents drained down into the limestone caves and subterranean waterways which make up the Florida aquifer, creating a tragic and permanent pollution of the subterranean river that flows from northern Florida to the Everglades. For a satellite’s eye view of the wreckage go to https://maps.google.com and do a search for “Purvis Still White Springs Florida.” Click on “satellite view”.
Organic farmers do not use commercial phosphate fertilizer. Most soils contain phosphate, and changing soil pH will liberate it. When organic farmers need to add phosphate, they obtain rock phosphate and mix it with manure or compost and wait a few months for it to break down. Conventional farmers are in too much of a hurry. Also, it is easy to overload soil with too much phosphate. Too much phosphate kills bacteria, earthworks, and other animal life.
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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, while AWWA and UL are smaller. NSF heads up the consortium which establishes methods and requirements for producing various chemicals, including fluoridation materials.
The application process is easy. Around 49 producers or resellers 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 may be valid when one is selling a product to a commercial buyer. However, it is also part of settled law that a disclaimer does not negate a stated representation or warranty, in this case that fluoridation materials are “safe” according to NSF.
Further, 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, after representing that it is safe and that some twenty toxicological studies have been done, 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? The answer is no.
This is the disclaimer in the MSDS which Mosaic 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:
“Univar USA expressly disclaims all express or implied warranties of merchantability 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:
“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 completely ineffective when a chemical is being sold to a water district for delivery to its human customers who are uninformed about the potential harm, especially given that NSF has made warranties which contradict the disclaimer.
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All 49 of the fluoride producers or resellers (the numbers vary) have applied for and obtained NSF 60 certification of their fluoridation materials. They all post the NSF Mark on their web sites and bills of lading. They know or should know that NSF Rule 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’ bills of lading, MSDSs, and other documents.
The involvement of NSF and the producers and resellers of fluoridation in the false certification of fluoridation materials bears all the marks of a RICO type fraud.
I have written lengthy letters to NSF and Simplot, warning them of their potential for liability. Neither has responded.
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 which managers working for NSF and for fluoride producers and suppliers can possibly have when the flood of 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 those who work for NSF, the suppliers, and the 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 or limit their liability.
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The NSF Rule 60 Standard imposes stringent requirements on NSF, requiring that NSF or its product suppliers perform such studies as “… 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”. What is the origin of this detailed list of toxicological studies which NSF or its suppliers are required to perform? Almost certainly, NSF did not impose these requirements on itself because NSF fails to do these tests. EPA put NSF into the fluoridation approval business and imposed the NSF Rule Book on NSF. Why would EPA create such an onerous list knowing that it would make it difficult for its NSF proxy to approve fluoridation materials to be “safe”?
My theory is that FDA wrote the list of required toxicological studies at the time when FDA and EPA entered into their Memorandum of Understanding. The FDA was about to assign responsibility over fluoridation to EPA, and the FDA probably assumed that EPA was going to ban fluoridation. To do that EPA would need a method to ban fluoridation, and running toxicological tests would be the best way to do that. EPA received the list of toxicological studies to be done from the FDA and failed to delete them when it was creating the NSF 60 Rule.
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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 proceeds as follows: Authority over fluoridation was wrestled away from the FDA by a clever EPA and then passed off to NSF. The producers and resellers obtain NSF 60 certification for their toxic product. However, the producers and resellers of fluoridation materials disclaim all liability in the fine print. 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.
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.
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Last but not least, we should look at the FDA’s part in all this. To its credit, the FDA withdrew its 1952 “not actionable” classification of fluoridation in 1996 and has never approved drinking water fluoridation since.
To its fault, the FDA has power to ban fluoridation but has failed to do so. Fluoridation is the mass drugging of 70% of the population with a harmful, mostly or completely ineffectual, and unapproved drug.
To its fault the FDA has allowed bottled water, juices, and other foods to be sold which are made from fluoridated tap water and which contain around 1 ppm fluoride. The fluoride content is not required to be posted on the label unless the bottler adds the fluoride.
To its fault the FDA has allowed the sale of fluoridated Nursery Water containing fluoride, although vendors may not claim health benefits.
To its fault the FDA has also allowed the sale of bottled water labeled as “fluoride added”. When fluoride is added, it may be added only up to .7 ppm.
To its fault the FDA allows the sale by prescription of Luride, which contains one milligram of sodium fluoride. This drug serves no beneficial role in the human body and is neither safe nor effective and should be banned.
To its fault the FDA has allowed itself to be cuckolded by the NSF. It would seem that the FDA would be infuriated at NSF for certifying fluoridation materials as safe for use as drinking water fluoridation drugs and thus usurping the FDA’s role. Likewise, the FDA should also be infuriated at EPA for helping NSF supplant FDA as the proper regulator of drinking water fluoridation drugs.
Note that the NSF only certifies fluoridation materials to be safe. NSF does not certify them to be safe and effective, as would the FDA – if the FDA were to approve fluoridation materials. So the NSF not only usurps FDA’s role, it usurps it incorrectly.
The FDA entered into a Memorandum of Understanding, numbered MOU 225-79-2001 with EPA that would have allowed EPA to ban water drinking fluoridation. Perhaps the FDA expected the EPA to do so. What did EPA do with that apparent authority? EPA instead set up a proxy NSF to certify fluoridation materials to be safe. EPA passed the job off to a private trade association which goes against science and the law and encourages people to drink a toxic substance. EPA administrators helped NSF do all this. NSF participates in a fraudulent conspiracy with the suppliers of fluoridation materials – with the approval of EPA.
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States which have mandatory fluoridation laws should immediately repeal them. They constitute a blatant violation of the Safe Drinking Water Act. The 47 states and nine Canadian provinces which have regulations which allow fluoridation provided that fluoridation materials comply with NSF Rule 60 should repeal such regulations – because NSF 60 mark does not mean what it purports to mean. States should immediately pass laws prohibiting any water district from adding any 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 and mass toxic tort actions against NSF and the suppliers. The cause of action would be for violation of state and federal consumer protection laws, for the money paid for the fraudulent fluoridation materials, for common law assault, and for misrepresentation. Because people have been harmed physically and thus assaulted, NSF and the suppliers should be prosecuted for criminal fraud.
Water districts should immediately terminate fluoridation. 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 NSF and the suppliers of fluoridation materials.
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The intent of the Safe Drinking Water Act is that pollution and contamination of all forms be eliminated in so far as possible. The Safe Drinking 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. [emphasis added]
These guidelines are being generally ignored.
The Safe Drinking Water Act does 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 legislatures and agencies cater to industry first, allowing the sale of any chemical which makes a profit for chemical companies, meanwhile forcing polluted consumers to endure the pollution or avoid it as best they can. They have shifted the burden from the chemical companies which should prove chemicals safe to consumers who currently must prove chemicals to be harmful. Unfortunately, chemists crank out new chemicals faster than consumers can convince EPA to ban them. The problem is hard to correct because our regulatory agencies have become captive to the industries they regulate by means of the “revolving door”..
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 the use of such chemicals. He says that the best chemist is not one which finds ways to use not the most chemicals but the fewest, particularly the fewest hazardous chemicals.
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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 and is safe. It is a drug which is distributed contrary to numerous 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 religion. 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.
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In conclusion, the FDC should approve petition number FDA-2015-P-1977-0001 submitted by Attorney Gerald Steel to the FDA, which proposes that the FDA declare that fluoridation materials (generally referred to inaccurately as “fluoride”) meet the definition of the legal term “drug”.
The FCD should approve the petition of Dr. Richard Sauerheber, numbered as FDA2007-P-0346, and “ban the intentional infusion of fluoridation materials into public drinking water.
The FDC should order NSF to discontinue the certification of fluoridation materials as safe.
The Washington Department of Health proposed rule on fluoridation should declare that fluoridation materials do not “comply with” NSF Rule 60 and that there are no fluoridation materials which may be added to drinking water. It should declare that the NSF certification of fluoridation materials is fraudulent.
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Note: A special thanks goes to Gerald Steel and Eloise Kailin for digging into the legislative history of fluoridation and to Dr. Richard Sauerheber for feedback. I have borrowed quite a few paragraphs from them.
Note: This document is updated frequently as new information is obtained. Go to www.Fluoride-Class-Action.com/Sham to read the latest version and to be able to follow links.
JAMES ROBERT DEAL ATTORNEY PLLC
PO Box 2276, Lynnwood, Washington 98036-2276
Telephone 425-771-1110 , Fax 425-776-8081
James at James Deal dot com
FDA Tracking Number: 1jz-8ksr-kqhg
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