Fluoride: A Toxic Tort Perspective – Panacea or Poison?

Fluoride: A Toxic Tort Perspective – Panacea or Poison?

(An Overview and Guide to Fluoride Toxic Tort Research)

By George Glasser ©Dec 1996 – Third Edition

Submitted to Leading Edge Research Web Site and Used By Permission Dec 23, 1996 of George GlasserGEORGE C. GLASSER …. 3016 23rd ST. N. …. ST. PETERSBURG, FL 33713  

INTRODUCTION

There are two sets of books on fluorides: One set says that fluoride is safe for everyone (with qualifications) while the other paints a more bleak portrait of a free radical that reacts with almost everything, an enzyme inhibitor and potent toxicant.

While almost everyone knows the term “fluoride,” virtually no one has any idea of what a fluoride is and that all fluorides are systemic, cumulative poisons. Unlike other substances found in common medicaments and food products which can cause adverse effects to subsets of the population or the general population, there are no adequate warnings on most products containing fluorides. If there is a warning, there is no mention that the fluoride is a causative.

Unfortunately, the public only sees selected bullets regarding fluoride’s questionable, beneficial effect as a cavity inhibitor and there is little or no mention of any adverse side effects. The inadequacy of warnings can especially impact subsets of the population who are most vulnerable to adverse effects from fluoride exposure.

As a matter of policy the US Public Health Service states: “There are health and economic benefits from water fluoridation for people of all ages and social and economic groups, especially for children who do not get adequate dental care.” However, fluorine compounds, fluorides, are listed by the US Agency for Toxic Substances and Disease Registry (ATSDR)/US Public Health Service (USPHS) as one of 275 substances that pose the most significant threat to human health. Consequently, under the provisions of the Superfund Act (CRECLA, 1986), a compilation of information about fluorides, hydrogen fluoride and fluorine and their effects on health were required to be published, Toxicological Profile for Fluorides, Hydrogen Fluoride and Fluorine (F), 1993.

Following the USPHS policy statement in the Toxicological Profile for Fluorides Hydrogen fluoride, and Fluorine (F), “Public Health Statement” are a series of comments contradicting the USPHS claims:

1. “However, exposure to certain levels of fluorides can harm your health. The effects depend on the type of fluoride you are exposed to, how long you are exposed, and how much gets into your body.”

2. “Fluoride in the drinking water may increase the risk of old men and women breaking a bone.”

3. “In general, the more soluble the fluoride containing substances is, the more toxic it is.”

4. “If you eat relatively large amounts of sodium fluoride, it can cause stomach aches, vomiting, and diarrhea.”

5. “It is not known if fluoride affects reproduction in people . . . Fluoride does cross the placenta from the mothers’ blood to the developing fetus. However, no birth defects related to fluoride were seen in one study.” (Human study)

6. “The bone cancer seen in the rat study is very rare in humans, although its frequency has recently increased in males in counties where the water is fluoridated. In spite of the geographical association, a careful analysis by the National Cancer Institute indicates that exposure to fluoride in the drinking water was not the cause of this increase.”

7. “Scientists within the PHS recently formed a committee to study the risks and benefits of exposure to fluoride. The committee prepared a report that states that fluoride in the drinking water helps prevent cavities. However, the scientists also said that there is a need to study fluoride further to find out more about other possible health effects in humans and animals exposed to fluoride in drinking water.”

While the USPHS says that fluorides have benefits for people of all ages, page 112 of the profile states: “POPULATIONS THAT ARE UNUSUALLY SUSCEPTIBLE. Existing data indicate that subsets of the population may be unusually susceptible to the effects of fluoride and its compounds. These populations include the elderly, people with deficiencies of calcium, magnesium and vitamin C, and people with cardiovascular and kidney problems . . . Poor nutrition increases the incidence and severity of dental fluorosis and skeletal fluorosis.”

In the United States, the population as a whole is kept ignorant of any adverse effect that might occur from exposure to fluorides. Even many attorneys specializing in toxic torts are unaware that fluorides are toxicants and have no idea that the Toxicological Profile for Fluorides, Hydrogen Fluoride, and Fluorine (F) exists while upwards to 80% of the people in the United States suffer with some form of fluoride intoxication, from hip fractures in the elderly to dental fluorosis.

Because of the prevailing ignorance, by both attorneys and the general public, regarding adverse health effects from exposure to fluorides, this guide was written to offer an overview and point of reference to initiate fluoride related toxic tort research.

 

1 –  FLUORIDE: PANACEA OR POISON?

“Fluoride has two faces, one apparently benevolent, the other unquestionably sinister.”1 (G.E. Smith, 1985)

It is said that fluorine is the 13th or 14th most abundant element on earth. In its elemental form, fluorine is a pale yellow, highly toxic and corrosive gas. In nature, fluorine is found combined with minerals as fluorides. Not accounting for industrial fluoride pollution, water fluoridation, ect., probably everyone is exposed to some form of fluorides. Most human exposure to fluorides prior to sixty years ago was primarily from natural sources such as naturally fluoridated drinking water, fluoride uptake in fruits and vegetables from the soil and seafood. However, over the past sixty years there has been a dramatic expansion of the industrial, domestic, agricultural and medical usages of fluorine-based products, thus the average person’s exposure has increased exponentially.

While fluorides are touted as beneficial, “a proven cavity fighter,” they are also on the Superfund Priorities List (CERCLA) of 275 toxic chemical substances which pose the most significant risk to human health. By Public Law 99-499, the USPHS/Agency for Toxic Substances and Disease Registry (ATSDR) was required to publish a toxicological profile for fluorides and update the document no less than every three years or when needed. The last revised document, Toxicological Profile for Fluorides, Hydrogen Fluoride and Fluorine (F), Department of Health and Human Services, USPHS/ATSDR was published in April 1993.2

In 1984, the Legal Research Journal, vol. 7. published an article, Toxic Research, Sources of Harmful Fluoride Intake, A List. It was stated: “Despite its salutory effect in teeth protection, it is increasingly suspected that a chronic fluoride intake, even at low levels, can cause health problems.”3

Law of Toxic Torts, Michael Dore, Minimizing Toxic Tort Liability Exposure for Product Sales, Chapter 3.03: “Once the causal connection between the product sold and the injury suffered by a claimant has been established there is precious little advice that can be given to manufacturers or sellers which will significantly improve their liability position. Prior to the establishment of such a connection, however, there are certain rules which, if followed, will dramatically reduce such toxic tort risks. 1. Consider the Issue at the Product Development State: Particularly if a product is likely to be used in a setting in which prolonged human exposure is anticipated, the risks of unexpected human health consequences should be considered to ensure that all necessary steps are taken to minimize these risks to the fullest extent scientifically possible . . . “4

The Toxicological Profile for Fluorides, Hydrogen Fluoride, and Fluorine (F) establishes that exposure to fluorides do, in fact, cause harm to the population in general and particularly to vulnerable subsets of the population.

 

2 –  WHAT IS A FLUORIDE?

By definition: Fluorides are the product of the element, fluorine, combined with another element or elements.

Fluorine (the parent of fluorides) is the most electronegative, oxidizing (corrosive) and reactive of all the known elements. When exposed to a stream of fluorine, water will burn. Fluorine, a member of the halogen family (pale yellow gas), cannot exist outside a controlled environment without combining with other substances to become fluorides (fluorine combines with all but a few elements to become fluorides).

There are ionizable and non-ionizable, organic and inorganic fluorides. The Chemical Rubber Company (CRC) Handbook of Chemistry and Physics lists more than 600 different fluorides. For the purpose of water fluoridation, highly ionizable salts (sodium fluorosilicate, potassium fluorosilicate and sodium fluoride) or fluorosilicic acid (solution) are used because they readily dissolve in water and release the fluoride ion (F-) which in turn seeks out hydrogen and other positive charged ions. The fluoride ion (F-) needs a companion and does not exist as a lone entity (you cannot purchase a pound of pure fluoride ions from a chemical supply company).5,6,7 On the other hand, non-ionizable fluorides such as some fluorocarbons do not readily dissolve in water and the molecule remains intact unless a chemical reaction takes place to release the F-.

Dr. Arthur Gregory, independent peer reviewer of the profile, chided the Public Health Service scientists for using the incomplete term “fluoride.” In his 1992 review of the second draft of the profile, Dr. Gregory stated: “The term “fluoride (F-)” is used throughout the profile as if it were a specific entity. It is not. The McGraw-Hill Dictionary of Science and Technology defines “Fluoride” as a compound derived from hydrofluoric acid. Fluoride does not exist by itself. Fluorine is the most chemically reactive of all the elements and is always associated with another entity. As a last resort F- (the fluoride ion) associates with itself to form Fluorine (F2). Fluorine, oxygen difluoride, chlorine trifluoride and related structures are strong oxidizers and can be highly destructive to living organisms both via chemical reaction with tissue and poisoning of the numerous body enzymes that require calcium and magnesium.”a

In the text of the Profile for Fluorides, Dr. Gregory’s stark and understandable definition of fluorides was not used. However, the authors did offer a more obscure definition: “In this profile, the term fluorides will be used to refer to common salts of the element fluorine.”

Because of fluorine’s corrosiveness and volatility when combined with other substances, for many years it was considered impractical to isolate large volumes of the element. Fluorine remained mainly a laboratory curiosity from the time it was first successfully isolated by Henri Moissan in the late 1800’s until the 1920’s. However, fluorine chemistry did not come of age until quantity production of the element (separation from fluorides) was required to refine uranium into uranium hexafluoride for production of the atomic bomb in the 1940’s.

Today, every facet of our lives is affected by fluorine chemistry: Computer chips, medicines, plastics, anesthetics, hypnotics, psychoactive stimulants, diet pills, analgesics, hormonal treatments, corticosteroids and numerous other medicaments, gasoline production, insecticides, pesticides, rodenticides, herbicides and fungicides, chemical warfare weapons, tobacco, aluminum, steel, Teflon, plastics, ceramics, bricks, industrial and domestic pollution, and the fluorides used for water fluoridation.8,9,10,11,12,13,

3 – FLUORIDE INTOXICATION HEALTH EFFECTS

Now, the primary concern of many researchers is that people are being exposed to inordinate levels of fluorides (ionizable and non-ionizable) and what the long term health effects could be. While there are literally thousands of studies addressing the health effects of fluorides, there are still more questions than answers. However, the preponderance of scientific evidence suggests that there is a narrow margin of safety between safe exposure levels and those of observed toxicity. Some scientists state that exposure to F- is akin to exposure to radioactive materials, suggesting there is no safe exposure level (paradoxical effect).14,15,16,17,18

The more soluble the fluoride, the more toxic it is; however, there are exceptions, often, fluorine in combination with another toxicant is synergistic (the interaction of two agents is greater than the sum of the components). Fluorine is listed as the most toxic member of the halogen family and second only to arsenic on the scale of toxicity (arsenic is considered the most toxic substance known). Calcium and magnesium fluorides found in naturally fluoridated water are less soluble and reactive than fluoride compounds used for artificial drinking water fluoridation.

Regarding fluoride toxicity, in general, not all fluorides are equal: Sodium fluoroacetate is about 200 times more toxic than calcium fluoride and 25 times that of sodium fluoride. And Sarin (nerve gas), the most potent fluorine-based compound, is so toxic that it requires less than a drop to kill a grown man, 0.01mg/kg. These estimates are based on acute dosage (exposure to a certainly lethal dose “CLD”).

Fluorine is also well known for its ability to potentiate (synergize) the toxicokinetics of poisons and pharmacokinetics of medicines and drugs.

In the 1979 American Dental Association’s White Paper on Fluoridation, toxic synergism was addressed, and in the document, it was stated: “Among specific subjects on which further research is needed are fluorides in skeletal biology, in heart disease, in utilization of minimal iron; the combined effects of two or more additives to the drinking water; and the long term effects of multiple sources of fluoride” (Page 16).

Again in the Journal of Dental Research, Vol. 69, pg. 584, Feb. 1990 there is a mention of toxic synergism in Recommendations from Session IV, Needed Research, # 7, “Consider variations in physiological, nonphysiological, and pathological changes __ for example, diet, ambient temperature, altitude, environmental pollution and disease states. Environmental pollutants __ heavy metals, for example __ should be monitored not just for their effects on F but for their other effects per se”.

There are three classes of poisoning: 1) Acute, which is short term, high dose intoxication (14 days or less; 2) intermediate (15-364 days); and 3) chronic which is long-term, low-level intoxication (365 or more).

Acute toxic reactions happen immediately; the effects are evident; they are generally treatable; and usually, there are no long-term side-effects. However, with prolonged low-level (chronic) exposure, the cause and effect relationship are not apparent and can be mistakenly attributed to other factors.

The average person is more likely to suffer from the effects of chronic, low-level fluoride intoxication. Consequently, the symptoms could be easily confused with common maladies for which the recommended medication could be a fluorine-based medicament such as Prozac or Fluacizine with manic depression thus exposing the person to even more fluorides.

Page 112, Toxicological Profile for Fluorides, “POPULATIONS THAT ARE UNUSUALLY SUSCEPTIBLE: Existing data indicate that subsets of the population may be unusually susceptible to the toxic effects of fluoride and its compounds. These populations include the elderly, people with deficiencies of calcium, magnesium and/or vitamin C, and people with cardiovascular and kidney problems . . . Poor nutrition increases the incidence and severity of dental fluorosis and skeletal fluorosis.”

On page 125 of the profile it is stated: “Neurotoxicity. Because fluoride interacts with calcium ions needed for effective neurotransmission, fluoride can affect the nervous system.” Although it was stated that fluorides interfere with the calcium flow essential for thought processes, the chronic neurotoxicokinetics of fluoride-metal complexes such as lead and mercury fluoride that occur in drinking water are not addressed in the profile. However, supporting the theory that the brain is a target organ for fluorides is the fact that many psychoactive drugs such as hypnotics, stimulants, antidepressants, anesthetics and sleeping aids are fluorine based.

Since 1992 there have been three studies confirming that fluorides affect brain functions. Dr. Robert Isaacson, Binghamton University, New York conducted two studies using low levels of aluminum and sodium fluoride. The levels were similar to the amounts people are exposed to on a daily basis from fluoridated toothpastes and drinking water. Results showed that both types of fluorides were neurotoxic. The most recent study published in Neurotoxicology and Teratology was done using large doses of sodium fluoride and corroborated the results of both Isaacson studies (1992 & 1994).19,20

All the studies demonstrated that the hippocampal region (learning center) of the brain was the most susceptible to the effects of fluorides.

It was also stated in the study published in Neurotoxicology and Teratology, 1995, Mullenix, et al, that: “Hyperactivity and cognitive deficits are generally linked with hippocampal damage, and in fact, the hippocampus is considered to be the central processor which integrates inputs from the environment, memory, and motivational stimuli to produce behavioral decisions and modify memory.” However, the researchers said that although the behavior of rats does not extrapolate to humans; the generic behavioral patterns created in rats from fluoride exposure can and probably do occur in humans. They also said the problems that might occur in humans from typical chronic fluoride exposure during pregnancy and early childhood are: “motor-sensory dysfunction, IQ deficits’ and/or learning disabilities” (environmentally induced retardation of brain development).

Dr. Stan Freni, scientist for the Division of Biometry and Risk Assessment, National Center for Toxicological Research, US Food and Drug Administration, said in a reproductive study of exposure to F- from water fluoridation, he felt that chemical interactions with fluorides in the water could play a role in reproduction and fertility problems. He also stated that total fluoride intake needed to be addressed. Intake of fluoride from naturally fluoridated drinking water was the only focus of his study.21

Literally hundreds of studies discuss the effect of fluoride on bones and teeth, which are the primary endpoints of fluoride intake. Many studies dating from the 1940’s suggest a strong association between fluoride exposure and bone strength. Recently, more studies suggest that fluoride exposure via drinking water is linked to hip fracture in the elderly population. On page 56-57 of the Toxicological Profile for Fluorides it states: “The weight of evidence from these experiments suggests that fluoride added to water can increase the risk of hip fracture in both elderly women and men . . . If this effect is confirmed, it would mean that hip fracture in the elderly would replace dental fluorosis as the most sensitive endpoint of fluoride exposure.”22,23,24,25,26

Dental fluorosis is the most visible effect induced by the ingestion of as little as 1.0mg of fluorides per day, causing a failure of the enamel to crystallize properly in the permanent teeth. Cases range from very mild (barely discernable opaque, chalky blotching of the teeth) to very severe (unsightly rust colored stains and surface pitting and brittleness of the teeth). 27 Dental fluorosis is a foreseeable condition that has been well known, and many studies have been published on dental fluorosis since the 1930’s.

In the Feb. 1990 Journal of Dental Research, Dr. Gary M. Whitford stated on page 546:

“Dental fluorosis. ___ There is a growing body of evidence which indicates that the prevalence of and in some cases the severity of dental fluorosis is increasing in both fluoridated and nonfluoridated areas . . . (1) It increases the risk of esthetically objectionable enamel defects; (2) it places dental professionals at an increased risk of litigation; and (3) it jeopardizes the perception of safety and, therefore, the public acceptance of the use of fluorides.” (Also see: ref. 26)

Many scientists and chemists state a concern about fluoride’s (F-) effect on the thyroid gland because of the law of halogen displacement. Any of the five halogens can displace an element with a higher atomic weight. The relative atomic weight of fluorine is 19 while iodine (essential for thyroid function) is 127. An impaired function of the thyroid gland will result in interruption of basal metabolic functions. Common problems associated with impaired thyroid function is chronic fatigue and/or hyperactivity. Little research has been done in this area.

Many animal studies offer insights into the mutagenic, teratogenic and genotoxic effects of fluorides; however, there is little data regarding humans. In Remington’s Pharmaceutical Sciences, 1980, pg. 983, it is stated that spontaneous abortion among female operating room personnel exposed to chronic low level, fluorinated (halogenated) anesthetics were 19.5-37.9% as compared with 8.8-11.4% in a similar number of unexposed personnel. “Other studies suggest that the live born offspring of both women and men chronically exposed to the operating room environment have increased incidence of congenital abnormalities.” The anesthetics include Enflurane, Fluoroexene, Halothane, and Methoxyflurane, all of which are fluorinated.

Ecological and clinical studies have suggested an “equivocal link” between fluorides and a rare and fatal form of bone cancer, osteosarcoma, which is peculiar to young males. Ecological studies have shown that U.S. osteosarcoma rates have increased by 53% in human males less than twenty years of age. The most significant increases have been in areas where the water is fluoridated. If nothing else, the weight of evidence would suggest that fluoride exposure is a cofactor in the dramatic increase of osteosarcoma.

Also, adding to the weight of evidence suggesting that fluorides could be a causative and/or co-causative for osteosarcoma is the marked increase in incidence of dental fluorosis in both fluoridated and nonfluoridated areas over the same period. (Osteosarcoma discussed further in segment 4)

 4 – THE PROBLEM WITH STUDIES

“Those who are for and against fluoridation have little common ground other than issues they disagree on. They cannot dialogue objectively because they have different realities. They see things differently, and have different criteria in determining validity. Our lives are enriched by artists for whom “beauty is in the eye of the beholder.” But our lives are often endangered when scientific truth is in the eye of the beholder.” (Dr. Schatz, discoverer of streptomycin)

A first criticism appearing in a legal journal regarding types of studies used to prove that fluorides are safe was by Michael Wollan in the 1968 George Washington Law Review. Mr. Wollan said, “The PHS was aware of and concerned about possible adverse medical consequences of the fluoridation, but its primary interest in confirming the benefits of fluoridation easily created a situation in which the issues brought out by the Select Committee in 1952 were not rigorously researched, particularly when the limited studies undertaken in naturally fluoridated areas had not yielded cases of serious physical harm.”b

Most clinical studies attempt to induce adverse health effects in laboratory animals by exposing them to high doses of chemicals for short periods. The method is similar to using hydroponics and artificial lighting to make a plant grow faster. The theory behind this approach is that in exposing animals to large doses over a short period, the result will be the same as a human exposed to small doses over a long period. From the information obtained by this method, scientists attempt to determine the safe exposure level, or the highest level of exposure that little or no adverse effect will occur, a linear dose-response.

All forms of fluorides are toxicants. However, most clinical studies are done with animals or humans using a pharmaceutical grade of sodium fluoride and are designed to determine a linear dose-response to F-. Animal studies generally use pedigreed, virus-free, disease resistant animals, fed special diets and distilled/deionized water, and administered high-grade sodium fluoride in controlled doses. Consequently, the results of such studies do not reflect the reality of everyday exposure to a variety of fluorides and the potential chemical interactions that are likely to occur.

The United States Public Health Service and Environmental Protection Agency base the safety and efficacy of municipal water fluoridation on the linear-dose response theory. The assumption is based on a scale of toxicity, the smaller the dose, the less toxic the effect (one dose fits all philosophy). Dr. Albert Schatz states in his paper, Low Level Fluoridation and Low Level Radiation – Two Case Histories of Misconduct in Science, that there is a fault with this assumption: “They assume that there is only one dose-response to fluoride and that dose-response is linear. They do not know that there are two distinctly different concentration ranges of fluoride. The dose-response they completely overlooked is the paradoxical, nonlinear dose-response. This occurs only with low-level fluoridation, just as it occurs only with low-level radiation, where it is described as supra-linear, quadratic and nonlinear.” Dr. Schatz goes on to describe how practices of adding iodine to water supplies and the therapeutic use of radium were abandoned. At one time it was said by the preponderance of scientists that radium was harmless and had therapeutic value, but the opposite has been proven true.

The present philosophy regarding clinical research is that of a linear dose-response to a particular specie of fluoride, and that is a pharmaceutical grade of sodium fluoride. Scientists are only concerned with how much F- a person can be exposed to before toxic effects will be observed (linear-dose response). All studies are based on the 1.0mg per day recommendation, and any dose below 1.0mg a day is ruled out as a causative factor for adverse toxic effects. A linear-dose response always appears at the maximum exposure range; however, the paradoxical effects surface where low-level, long-term (chronic) intoxication occurs and is affected by variables like environmental, economic, and physiological factors. These variables are not considered in conventional studies based on the linear-dose response theory.

Epidemiological, ecological and population studies are generally performed in areas where the water is naturally fluoridated. In naturally fluoridated areas, F- is generally bound with calcium and magnesium which are 20-25 times less toxic than sodium fluoride or the effluent fluorosilicates. These studies address only intake of fluoridated water and not total fluoride intake. Also, not addressed are the malnourished, susceptible ethnic subsets of the population, health status of subsets of the population such as people with cardiovascular, kidney, and thyroid problems or diabetes.

Most studies commissioned regarding fluoride intake are designed to investigate one aspect of exposure and that is ingestion of fluoridated water. The manufacturers of fluorine-based pharmaceuticals do a more thorough job of testing products. Monographs and research from fluorine-based pharmaceuticals in the Physician’s Desk Reference and other publications offer insights into the pharmacokinetics, toxicokinetics and toxic synergism of fluoride compounds and their effects on animals, insects and humans.

An example of the synergistic toxicokinetics of fluorides is when DuPont’s fungicide, Benlate DF, was contaminated with a fluorine-based fungicide, Flusilazole. Flusilazole is not registered for use in the United States.28 The combination of the two products created a super mutagen which was found toxic at parts per trillion. Wearing protective gear and properly decontaminated, Haz-Mat teams removing the contaminated dirt from farms became ill. It required the development of special equipment to determine the amount of chemicals in the body because toxic levels were so minute. It also only requires a thimble-full of Benlate to treat one acre of land. The contaminated Benlate caused the worst environmental catastrophe in Florida’s history, and no one knows what volatile concoctions are created when chemicals of this type mingle in nature. The outcome is beyond solid scientific speculation.29

Most of the people in the United States are exposed to fluorides from community water fluoridation. Most research is designed to determine the effects of exposure to F- from the average consumption of water per day by a person according to age, not total fluoride exposure from incidental environmental media. Other factors such as toxic synergism are not considered in current epidemiological, population and clinical studies.

The most commonly used agents for water fluoridation, fluorosilicic acid and sodium fluorosilicate, are derived from pollution scrubbing operations at phosphate fertilizer manufacturing facilities. Unlike the pharmaceutical grade of sodium fluoride used for clinical research or the almost benign magnesium and calcium fluorides found in naturally fluoridated water, the industrial waste fluorides are contaminated with mercury-fluoride, cadmium-fluoride, lead-fluoride, arsenic-fluoride, uranium-fluoride, and polonium fluoride ( 1.0mg of polonium fluoride gives off as much alpha radiation as 5.0 grams of radium), radium-fluoride, and radon fluoride among others. After 25 years of extensive use as water fluoridation agents, not one study can be obtained regarding the safety and effectiveness of using phosphate fertilizer production effluent fluorides.30,31

In Florida, which is a major source for fluorosilicates used for water fluoridation, the phosphate rock contains up to 3.5% total fluorine and up to 300 parts per million of uranium oxide. Residual scale scrubbed from filtration systems at superphosphate fertilizer production facilities contains up to 100,000 picocuries of radioactive wastes, referred to as NORM waste (naturally occurring radioactive materials). In fluorosilicates, these waste products would be radioactive fluorides. Neither the USEPA, the manufacturers, National Sanitation Foundation 32 nor the American Water Works Association offer any data regarding the levels of alpha and beta radiation in the fluorosilicates (alpha radiation is of most concern). However, the wash water from superphosphate fertilizer production can contain between 30-40 picocuries of radionuclides per liter. Fluorosilicic acid is a 23% solution of fluorosilicates derived from pollution scrubbing operations.33,34

Uranium and its daughters (radium, radon and polonium) are known carcinogens (produce osteosarcoma), and like fluorides, they are bone seekers. Although these substances are present as fluorides in fluorosilicates, there is no available data or research regarding health effects from chronic exposure to these fluorides. An August 12, 1986-letter from Dr. John Cotruvo, USEPA, Office of Drinking water to a G. England regarding radionuclides in fluorosilicic acid stated that the USEPA does not consider the amounts to pose a significant health risk. Consequently, manufacturers are not required to monitor radionuclide levels.

The most controversial aspect of fluoride research is a rare and fatal form of bone cancer generally occurring in young males, osteosarcoma. With the results of both the NTP and Proctor and Gamble studies, what constituted a cancer by one scientist was another’s benign tumor. The fact that osteosarcomas were found in male rats (as with human males) and not female rats were a deciding factor in designating the results of the NTP study, equivocal.36,37,38

The results of the NTP and Proctor and Gamble carcinogenicity studies reviewed in the Toxicological Profile for Fluorides are contradictory and qualified with introductory statements like: “The osteosarcoma rate has increased markedly in recent years, but thorough statistical analyses concluded the effect was not due to fluoride. None-the-less, analytical epidemiological studies to determine the risk factors for osteosarcoma may be useful”; and “The bone cancers seen in the rat study is rare in humans, although its frequency has recently increased among males in counties with fluoridated water. In spite of this geographical association, a careful analysis by the National Cancer Association indicates that exposure to fluoride in drinking water was not the cause of this increase.” The population and epidemiological studies (with a 10-20% margin of error) used to disprove that fluorides cause osteosarcoma were criticized by the independent panel for not being sensitive enough.

The results of the NTP study stated that there was an equivocal risk of developing cancer (osteosarcoma) from oral fluoride exposure. This was because some male rats in the study developed osteosarcomas which are also peculiar to young human males. While the evidence was stated as equivocal in the NTP study, the fact remained that no animals in the control group had developed osteosarcoma. Osteosarcoma is virtually unknown in animals, especially rats.

The results of both the human epidemiological study and the clinical rat study showed that the males of both species exposed to fluorides seemed to more readily develop osteosarcoma.

Regarding the NTP study, Dr. William Marcus, Senior Science Advisor/Toxicologist, USEPA, Office of Water, said in a 1995 radio interview (Gary Null, New York), “I have been trying to produce osteosarcoma in animals for almost twenty years; and the only luck I have ever had is with dogs and monkeys; and the osteosarcomas took nearly the lifetime of the animals; and we were using radium which specifically produces that in bones; and here we have a compound, commonly available, that did it in rats in two years or less.” He also addressed the fact that many cancerous and precancerous tumors were downgraded in the study including a “very rare liver cancer,” hepatocholangiocarcinoma.

Dr. Marcus also said that in the twenty-five years that he had been a toxicologist with the USEPA: “I have seen one or two endpoints argued over, usually on what is a cancer in that particular tissue, but I have never seen every single one of them downgraded.”.

From the critiques of numerous scientists and researchers of the NTP study, several indisputable facts surfaced: There were no osteosarcomas in the control groups. All the dissenting scientists felt that the results had been downgraded with regards to osteosarcomas and liver cancer.

The Proctor and Gamble study is considered the gold standard and often quoted by fluoridation proponents as the definitive study proving that fluorides do not cause cancer. However, a critique of the Proctor and Gamble study in the Profile for Fluorides which ended in early termination of the study because of unexplained high mortality rates in all treatment and control groups, cited the following flaws: (1) Bone tumors were missed by the contract laboratory; (2) only 50-80% of the bones of animals exposed to low and mid-range fluoride doses were examined; (3) ambient fluoride levels in the water and feed were not determined or reported; (4) neither the diet and/or water was maintained to standard, and the mineral, ion and vitamin levels were often above specifications; (5) the rats had a virus existing prior to and during the study that could have affected the outcome such as early mortality; and (6) the high mortality rate among the rats was not explained.

Despite the notable flaws in the Proctor and Gamble study, the Carcinogenicity Assessment Committee (CAC), Center for Drug Evaluation and Research, U.S. Food and Drug Administration concluded that fluorides posed no cancer risk and the Proctor and Gamble study was adequate. It is also interesting that both studies used a pharmaceutical grade of sodium fluoride while the most used water fluoridation agents, fluorosilicates, derived from superphosphate fertilizer manufacturing contain uranium and its daughters, which are the only known causatives of osteosarcoma.

Research and studies concentrating on the effects of F- are only addressing one aspect of a complex puzzle. Many pieces are missing and others are buried between the lines of monographs in medical, pharmaceutical, agricultural and chemistry reference books, eg. Physician’s Desk Reference and Farm Chemicals Handbook.

Also, all epidemiological studies which deal with fluoride exposure levels of more than

1.0 part per million in the drinking water use data obtained from areas where the water is naturally fluoridated. The fluoride ions found in naturally fluoridated water are generally bound with calcium and magnesium which are not as soluble or reactive as artificial fluoridation agents therefore less toxicokinetic. Research data obtained from naturally fluoridated areas do not offer a complete picture regarding health risks.

   5 – SOURCES OF FLUORIDE EXPOSURE

Most government and industry-sponsored studies only consider the average amount of F- ingested by a person from drinking water fluoridated at 1.0mg/L. However, most people are exposed to multiple sources and fluoride species via bioavailability from environmental media and bioaccumulation/biomagnification in the food chain,39 all of which the individual levels may be considered safe, but the total intake for the average person may exceed safe levels.

In the Toxicological Profile for Fluorides, it states that from dietary sources alone, the average person is exposed to 2.7mg per day of fluoride (F-). However, in almost every study regarding a total fluoride intake, the researchers state that there is no way of determining the actual intake of fluorides by the average person. Brushing one’s teeth with fluoridated toothpaste, twice a day, would expose a person to at least 2.0mg of the active fluoride ion (F-). Some fruit juices contain up to 6.7 mg/L of fluorides from residual fluorine-based pesticides, fungicides and herbicides. If a person is using a fluorine-based medicament, supplement or drug, he or she could be exposed to potentially toxic doses of fluorides per day.40,41,42

Not discussed to any extent in the profile was the metabolism of fluorides by plants, although several peer reviewers’ felt that plant uptake of fluorides was an important factor when considering the total intake and toxicokinetics of fluorides for humans. However, Dr. Thomas Hensely’s review of the 1990 draft of the profile included: “….But there is no mention of a need for further research to determine potential hazards associated with accumulations of fluorides in and the production of fluorocarbons by growing plants. Nevertheless, it appears that fluorocarbons produced by and contained in plants are several hundred times more toxic to animals than inorganic fluorides. Since food is the major route of human exposure to fluorides, further research is needed to determine plant uptake and accumulations of the nonessential element.”c

Cooking with fluoridated water poses another source of exposure to fluorides. Heating fluoridated water only concentrates the fluorides; consequently, cooked foods contain higher levels of fluorides per volume. Because fluoride (F-) is so reactive, heat also affects how F- reacts with other compounds such as food preservatives, agricultural residuals and chlorine. There has been no research noted in the profile or other references regarding interactions of this nature.

While the USPHS states that fluorides are beneficial for people of all ages,43 on the first page (Public Health Statement) of the Toxicological Profile for Fluorides, the context of the book is qualified with the statement: “If you are exposed to substances such as fluorine, hydrogen fluoride, or fluorides, several factors determine whether harmful effects will occur and what type and severity of those health effects will be. These factors include the dose (how much), the duration (how long), the route or pathway by which you are exposed (breathing, eating, drinking, or skin contact), the other chemicals to which you are exposed, and your individual characteristics such as age, sex, nutritional status, family traits, life style, and state of health.” On page 3, it states that fluoride exposure to the average person can occur from household products although primary exposure is from fluoridated drinking water, toothpastes, mouth rinses and fluoride gels (not mentioned in the Public Health Statement were, processed foods and beverages made with fluoridated water, residual and systemic fluorine-based pesticides, fungicides and herbicides on produce, fluoride uptake in fruits and vegetables from phosphate fertilizers, and fluorine-based medicaments and drugs): “If you swallow the treated water, or these products, you will be exposed to fluorides.”44

Most people who promote water fluoridation and the use of fluoride-laced supplements mistakenly say that fluoride (F-) is a nutrient or essential element; in 1989, the National Academy of Sciences determined that fluorides were not essential for human development.45

6 – DETERMINING FLUORIDE TOXICITY

There are several methods for determining fluoride toxicity: Serum, urine, tooth enamel, bone and hair analyses. However, analyses can be deceiving depending on whether the samples are analyzed for only F- or total fluorine (ionizable and non ionizable fluorides).

To determine recent, acute exposure, urine analysis preferred by researchers to serum analysis; to determine fluoride exposures for up to a year, hair analysis for total fluorine is the most accurate method; and bone analysis for total fluorine would indicate lifetime exposure.46

7 – FLUORIDE RELATED TOXIC TORTS

Fluoride (F-) is primarily a teeth and bone seeker. In children, up to 50% of the ingested fluoride is deposited in the teeth and bones, and with adults the deposited fluorides can be as high as 20%.

The use of fluorides as a cavity preventive is well known; however, its actual effectiveness is widely contested. The most obvious adverse side-effect is mottled teeth (dental fluorosis). On a smaller scale, combinations of sodium fluoride and calcium are used to treat osteoporosis; however, the preponderance of studies states that although sodium fluoride treatments do produce bone mass, but the generated bone is brittle and subject to fracture.

The most litigable aspect of fluoride intoxication is DENTAL FLUOROSIS. It is considered a cosmetic effect by the USPHS; however, in Taber’s Cylopedic Medical Dictionary, dental fluorosis is a condition resulting from chronic fluoride intoxication or a pathological effect.47,48

Sixty years ago, dental fluorosis was endemic to areas where the water was naturally fluoridated. Today, the condition is pandemic in the United States with estimates ranging from 20-40% in nonfluoridated areas and 40-84% in fluoridated areas. Dental fluorosis is classified according to Deans Index: 1) Mild: Barely discernable chalky blotching; 2) Moderate: Discernable chalking blotching to rust colored stains on teeth; and 3) Severe: Stained, pitted and friable teeth. Dental fluorosis is a permanent condition and there are only costly, temporary remedies such as bleaching, micro-abrasion, cosmetic bonding and capping. Most cases of severe dental fluorosis result in a loss of teeth, or the formation of cavities in fluorosed areas. In cases where the teeth have become friable, repairing cavities is difficult, if not possible.

It was established in 1916 that fluoride exposure caused dental fluorosis, then in 1942 it was estimated by Dean et al that 10% or more of the children ingesting water (alone) containing 1.0mg/L of fluorides would develop the condition. When these estimates were made, the only consideration was how much water was drank per day, fluoridated at 1.0mg/L. Since there were no fluoride treatments, supplements and other environmental sources of fluorides were minimal, the standard for fluoridating drinking water was established at 1.0mg/L, and that initial recommendation stands today despite the ubiquitousness of fluorides in the environment.49,50

Regarding dental fluorosis toxic tort litigation, several important precedents would apply:

1) Foreseeability 51,52

2) Duty to warn 53

3) Causation:54

a) ” The exposure to the chemical or chemicals did, in fact, occur;

b) The disease or injury complained of did, in fact, occur;

c) An appropriate period of time elapsed between the exposure and onset of disease;

d) Scientific recognition exists as to the relationship between the

chemical(s) and injury or disease;

e) Exposure to dose or amount of the chemical was sufficient to cause the injury did occur;

f) Exposure was of such a nature as to cause the injury; and

g) Recognized alternative causes of the injury or disease(s) complained of have been eliminated.”55

Feldman v. Lederle Laboratories, the plaintiff filed a suit claiming that the discoloration of her teeth was caused by medication prescribed during her infancy.56 The plaintiff’s claim was that the defendant was strictly liable for the discoloration of her teeth because the defendant did not warn her of the potential side effect of the drug. It was argued by the defendant that at the time Feldman was administered the drug, it was scientifically impossible to know the potential side effect and therefore to provide warnings of the dangerous side effect.

In Feldman v. Lederle Laboratories, the New Jersey Supreme Court stated that it was the defendant’s responsibility to prove that the information was not reasonably accessible at the time; and consequently, lacked actual or constructive knowledge. The Court held that if the risk was scientifically unknowable that no liability could be attached to the defendant’s failure to warn.

However, with dental fluorosis, the adverse side effect has been common scientific knowledge for more than ninety years. Communities fluoridating water, the promoters of water fluoridation, and the manufacturers of fluoride-laced dentifrices do not provide adequate warnings to the public regarding the scientifically knowable adverse effect, dental fluorosis. The argument is straightforward: The undeniable fact is that exposure to fluorides cause dental fluorosis, and the potential defendants are aware that ingestion of fluorides will cause discoloration of the teeth; and the potential defendants have failed to adequately warn the public of this adverse effect.57

Hip fracture is the second most litigable aspect of fluoride exposure. Studies have indicated a strong association between chronic fluoride exposure (drinking water fluoridated at 1mg/L) and hip fracture. Although fluoride related hip fracture would be more difficult to establish, pursuing such litigation is feasible if, in fact, the plaintiff has lived in a fluoridated area for a number of years. To prove lifelong fluoride intoxication of the nature to cause hip fracture, analysis of a bone biopsy for total fluorine would be essential.

Considering a toxic tort action, the sources of harmful fluoride intake would indicate that there would be more than one defendant. While the USPHS states that water fluoridated at 1.0mg/L is safe, it is still the primary, contributory factor exacerbating fluoride toxicity and the vehicle by which most people are exposed to fluorides.

Exposure occurs not only from drinking the water, but intake of beverages and foods prepared with the fluoridated water. Fluorinated dentifrices are second, residual fluorine-based agricultural products are third and fluorine-based medicaments would be fourth in the sequence of primary sources of exposure for the average person.

8

8 – TOXIC TORT RESEARCH: WHERE TO BEGIN

As with investigative writing, all research begins with opening the first book and pursuing the reference which, in turn, leads to more articles and publications with more references, and so on. The reference section in this guide is the compilation of two years of investigative writing about fluorides that affords the legal researcher an eclectic overview not found in most studies or articles on the subject.

The Toxicological profile for Fluorides is the most logical starting point for toxic tort research. However, the profile is only about 85% complete and somewhat contradictory in context. Upon obtaining the profile, it is also of value to request the peer reviewers comments, notes and suggestions not included in the document (as stated in Appendix C-1). The peer reviewers’ comments can be obtained from the US Centers for Disease Control Information Office with a Freedom of Information Request.

With regards to the legal aspects of toxic tort litigation, Law of Toxic Torts, Michael Dore is the most comprehensive publication on the subject.

From information reviewed, fluoride toxic tort cases (of which there are only a few) after the 1970’s have been settled out of court or dropped and none have reached class action status in the United States. There have been two attempts in the United Kingdom to sue for children suffering with dental fluorosis, but the government refused to fund the effort. Suits prior to 1970 dealt with environmental fluoride pollution damage to crops, livestock, nurseries (plants) and tropical fish farms.58

 

9 – CONCLUSION

[l] Difference Between Inadequate Warning and Other Product Defects

§508(1)

” Unlike most product defects whose consequences are relatively clear, products or materials which are defective because they do not contain adequate warnings as to their contents or use do not malfunction in any consistent and predictable way. The differing ways in which various parties interact with products with inadequate warnings make the consequences of these inadequate in that it did not adequately disclose the risks of using the product, but also that the inadequate warning was the cause of the plaintiff’s harm because an adequate warning would have disclosed those risks, and that disclosure would have been heeded by the claimant, The causation which the plaintiff must demonstrate “is not merely causation between the use of the product and the injury; plaintiff has the affirmative burden of establishing causation between the failure to warn and the injury. 72 (56 in references)”

(Law of Toxic Torts, Michael Dore)

Undoubtedly, fluorine chemistry has improved the quality of our lives, but the unrestricted use of fluorine-based products such as chlorofluorocarbons, ect. is simultaneously diminishing the quality of all life. With the use of fluorine-based products, especially where prolonged (chronic) exposure is involved, it is the obligation of manufacturers and municipalities fluoridating drinking water to inform the public of any health risks occurring from exposure to fluorides in those products such as dental fluorosis, the potential of hip fractures in later life, or people who might be at risk from ingesting those products.

The practice of community water fluoridation is dose-related to how much water an average individual drinks per day (about eight 8.0oz glasses of water fluoridated at one part per million = a dose of 2.0mg of F-, or twice the optimal recommended dose of F- for a person more than 12 years).59,60 However, not factored into the dosage schedule are foods prepared with fluoridated water, beverages made with fluoridated water, the use of fluoride-laced dentifrices and ubiquitous fluorides contained in food-stuffs and drugs. All these sources contribute to an average daily intake which can exceed what is considered safe levels.

It has also been established that there are subsets of the population who are particularly vulnerable to exposure to low levels of fluorides in the drinking water; consequently, local and state governments who mandate water fluoridation are doing so with the intent to cause harm to those vulnerable subsets of the population.

Although community drinking water fluoridation is considered a “public health measure,” and the US Supreme Court has determined that the practice does not violate constitutional law and falls under the Police Powers Act, the practice does conflict with provisions of the: Safe Drinking Water Act (SDWA), 42 U.S.C. § 300i, Tampering with public water systems (PHSA § 1432), Toxic Substances Control Act (TSCA § 15), 15 U.S.C. § 2614 (a) (2), Prohibited Acts, and Food Drug and Cosmetic Act (FFDCA), 21 U.S.C. § 331 (a)-(k), Prohibited acts.

These acts would apply because the term fluoride is used generically. According to the present generic definition, any specie of fluorides, no matter how toxic, carcinogenic or otherwise could be substituted as a water fluoridation agent for the more benign, surrogate fluorides used for research purposes. To date there has been no clinical research regarding safety and efficacy performed with the fluorides derived from pollution scrubbing operations which are used for the purpose community water fluoridation.61,62

Whether or not fluorides have a salutory effect on the teeth, or fluorides in a particular product pose a minimal health risk to any individual, it is the cumulative amounts of fluorides individuals are exposed that create health risks. Consequently, each source of fluorides is a contributory factor to any adverse health effect associated with fluorides added to the drinking water, products produced from fluoridated water or a product containing contaminant fluorides from other media. Therefore it is not only the legal responsibility, but also the moral obligation of the manufacturers of those products or communities artificially fluoridating drinking water to warn the general population of any health risk from ingesting fluorides and especially those subsets of the population who are particularly susceptible to adverse health effects from minimal exposure to fluorides.

Organizations and parties (such as newspaper ediorial endorsements) endorsing the practice of water fluoridation and/or the indiscriminate use of fluorides would also share limited liability for negligent misrepresentation [Yuhas v. Mudge, 129 N.J. Super. 207, 322 A. 2d 824 (1974); and Hanberry v. Hearst Corp., 276,Ca.App.2d 680, Cla.Rptr. 519 (1969)].

With regards to fluoride toxic torts, dental fluorosis could possibly be the most mammoth class action in history, dwarfing asbestos litigation. Recently, November 1996, United Kingdom, Colgate settled a dental Fluorosis case out of court wnich established liability for the condition. Up to 50% of the US population less than thirty years old has probably developed dental fluorosis. Once the door is opened to fluoride toxic torts with dental fluorosis, hip fracture will be the next logical point of toxic tort litigation, and from that point, possibly osteosarcoma along with numerous other adverse effects to which vulnerable subsets of the population are susceptible. Fluoride related toxic torts will not be a single point for litigation, but a specialized area of law encompassing many subtle aspects.

REFERENCES

1. Fluoride and Bone: an unusual hypothesis, G.E. Smith, Xenobiotica, 1985, vol. 15, no. 3, 177-186.

2. Toxicological Profile for Fluorides, Hydrogen Fluoride, and Fluorine (F), USDHHS, USPHS, ATSDR, April 1993.

3. Toxic Research, Sources of Harmful Fluoride Intake, A List, Research Tools Committee, Legal Research Journal, 1984, vol. 7, issue 5.

4. The Law of Toxic Torts, Michael Dore, 1994, Clark Boardman Callaghan Company, Ltd.

5. AWWA Standard For Fluorosilicic Acid, B70394, AWWA Standard for Sodium Fluoride, Sodium Fluorosilicate, and Potassium Fluorosilicate B703-94, American Water Works Association 1994.

6. Lucier Chemical Industries, Ltd. (LCI), Hydrofluosilicic Acid Specifications, H2SiF6, Commercial Grade, Oct., 1990. Used for water fluoridation, all fluoridation and water treatments agents are commercial grade.

7. Fluorine recovery in the fertilizer industry – a review, Denzinger, H.F., König, H.J., Krüger, G.E., Phosphorus & Potassium, no. 103, Sept/Oct. 1979.

8. CRC Handbook of Chemistry and Physics, #8, 1992-93, The Chemical Rubber Co.

9. Fluoridation: The Great Dilemma, 1978, George L. Waldbott, M.D., Burgstahler, A., McKinney, G, Coronado Press, Inc.

10. Occupational Diseases, A Guide to Their Recognition, 1977, U.S. Public Health Service (Has not been revised to date).

11. Remington’s Pharmaceutical Sciences, Mack Publishing Company.

12. The Merck Index, An Encyclopedia of Chemicals, Drugs, and Biologicals, Merck Research Laboratories, Merck & Co., Inc.

13. Physicians’ Desk Reference, Medical Economics Co., Ltd.

14. Commentary on the Recommendations for the proper uses of Fluoride, Horowitz, H.S., Jour. Of Public Health Dentistry, vol. 55, no. 1, Winter 1995.

15. Physiological and Toxicological Characteristics of Fluoride, Whitford, G.M., Journal of Dental Research, Vol 69, Feb. 1990.

16. The amounts of fluoride in current fluoride therapies: safety considerations for children, Heifetz, S.B., Horowitz, H.S., Journal of Dentistry for Children, July-August 1984.

17. Schatz, A., Schalscha, E.B., Zhang, D., Wu, X., Effect of Organic Matter as a Natural Chelating Material; Part Two, The Occurrence and Importance of Paradoxical Concentration Effects in Biological Systems, Compost Science, 5; 22-30; Spring 1964.

18. Our Stolen Future, Colborn, T., Dumanoski, D., Myers, J.P., Penguin Books U.S.A., 1996.

19. Air Pollutants Affecting the Performance of Domestic Animals, Agricultural Handbook No. 380, Robert J. Lillie, 1970, US Dept. of Health, Education and Welfare.

20. Neurotoxicity of Sodium Fluoride in Rats, Neurotoxicology and Teratology, 1995, Vol. 17, No. 2, pp. 169-177; Mullenix, P.J., Denbesten, P.K., Schunior, A., and Kernan, W.J.

21. Society for Neural Science, 1995. The Abstract from the Neurotoxicological Evaluation of the Chronic Administration of Aluminum Fluoride and Sodium Fluoride, Valmer, Jenson, Horvath & Isaacson. Also see: The Concept of Direct and Indirect Neurotoxicity and the Concept of Toxic Metal/Essential Element Interactions as a Common Biomechanism Underlying Metal Toxicity, Chapter 5, vol 1; Chapter 11; Silver Impregnation of Organophosphorus-Induced Delayed Neuropathy in the Central Nervous System, Chapter 12, The Vulnerable Brain and Environmental Risks, vol. 2, eds. Robert Isaacson & Karl F. Jenson. New York; Plenum Press, 1994.

22. EXPOSURE TO HIGH FLUORIDE CONCENTRATIONS IN DRINKING WATER IS ASSOCIATED WITH DECREASED BIRTH RATES, Freni, S.C., Jour. of Toxicology and Environmental Health, 42:109-121, 1994 U.S.; Food and Drug Admin. study.

23. Fluoride and Bone Health, Phipps, K., Jour. of Public Health Dentistry, Winter 1995, vol. 55, no.5.

24. Hip Fractures and Fluoridation in Utah’s Elderly Population, Danielson C, Lyon JL, Egger ME, Goodenough J, Journal of the American Medical Association 1995; 268: 773748.

25. Fluorine Concentrations in Drinking Water in the Elderly, Journal of the American Medical Association Jacqmin, D., Gedde H., Commenges D., Dartiques J.F., 1995; 273: 773-776.

26. Health Effects of Ingested Fluoride, 1993 NRC/NAS, EPA contracted.

27. Proceedings of Joint IADR/ORCA International Symposium on Fluorides: Mechanisms of Action and Recommendations for Use, March 21-24, 1989, Jour. Of Dent. Research, Feb., 1990, vol 69.

28. Farm Chemicals Handbook, 1995, Meister Publishing Company.

29. Tampa Tribune six part series, Pandora’s Box, appearing from 12/17-22/95. The Benlate series can be obtained from Tampa Bay Online or on TBO’s http://w.w.w.tampatrib.com. In articles dating back to the early nineties, the Tampa Tribune has also covered many aspects of the Benlate problem and environmental concerns about the phosphate fertilizer industry.

30. Correspondence from the USEPA, June 15, 1995 to George Glasser from Tudor Davies.

31. Analyses of Some Selected Phosphate Rocks, Florida Institute of Phosphate Research

32. The National Sanitation Foundation is contracted by the USEPA to establish quality standards for water treatment chemicals, including fluorides. The American Waterworks Association writes and publishes the standards for fluoridation agents, AWWA Standard For Fluorosilicic Acid, B70394, 1994.

33. Wastes bypass federal regulation despite radioactivity, Gunter, B., Kennedy, M., Tampa Tribune, 21 July 1991.

34. Estimate for picocuries in phosphate fertilizer waste water obtained from Florida Department of Environmental Regulation.

35. A picocurie is about a trillionth of a gram as dertimined by Radium 226, the maximum allowable contaminant level (MCL) allowed in drinking water by the USEPA is 5.0 picocuries/Liter.

36. Maurer, J.K., Chang, M.C., Boysen, B.G., et al. 1990, 2-year Carcinogenicity Study of Sodium Fluoride in Rats, Jour. National Cancer Institute, 82 (13): 118-1126.

37. International J. of Cancer, 1991, “Results and Conclusions of The National Toxicology Programs Rodent Study with Sodium Fluoride.

38. A Breif Report on the Association of Drinking Water Fluoridation and the Incidence of Osteosarcoma among Young Males, New Jersey Department of Health, Nov. 1992.

39. Gaseous Fluoride Emissions From Gypsum Settling and Cooling Ponds, Howard E. Moore, Florida Scientist, vol 50, Spring 1987, pages 65-78.

40. Relationship of Total Fluoride Intake to Beneficial Effects and Enamel Fluorosis, Pendrys, D.G., Stamm, Jour. of Dental Research, vol. 69, Feb. 1990.

41. The Physiological and Toxicological Characteristics of Fluoride, Whitford, G.M., Jour. of Dental Research, vo,. 69, Feb. 1990.

42. Pharmacokinetics of Fluoride in Man and its Clinical Relevance, Ekstrand, J., Spack, C.J., Vogel, G., Jour. of Dental Research, vol. 69, Feb. 1990.

43. Review of Fluoride: Benefits and Risks of Fluoride, USPHS, 1991.

44. Sources of Fluoride Intake in Children, Levey, S.M., Kristy, M.C., Warren, J.J., Jour. Of Public Heath Dentistry, vol. 55, no. 1, Winter 1995.

45. The non-essentiality of fluorine in nutrition, Maurer, R.L., Day, H.G., Jour. of Nature, 62:561-573, 1957.

46. Evaluation of Analytical Methods for Fluorine in Biological and Related Materials, P. Venkateswarlu, P., Jour. of Dental Research, Feb, 1990, Vol. 69.

47. Risk Factors of Dental Fluorosis in Pediatric Dental Patients, Journal of Public Health Dentistry, Vol. 36, No. 3, Summer 1995.

(28) Bawden J.W., ed., Changing Patterns of Fluoride intake. Proceedings of the

workshop, J. Dent. Research, 1992;71:1212-27.

(31) U.S. Public Health Service. Report of the ad hoc subcommittee to

coordinate environmental health and related programs. Review of fluoride

benefits and risks. Washington, DC: US Department of Health and Human

Services, 1991.

(32) Clark C., ed., Report of the Canadian Workshop on the evaluation of current recommendations concerning fluorides. Community Dent. Oral Epidemo. 1994; 22:139-86.

(33) Horowitz H.S., The need for toothpastes with lower concentrations for preschool-

aged children, Public Health Dent. 1992; 52:216-21.

(34) Whitford G.M., Acute and chronic fluoride toxicity, J. Dent. Research

1992;71:1249-54.

48. Health Effects of Ingested Fluoride, NRC/NAS 1993.

49. Domestic water and dental caries, Dean, H.D., Arnold, F.A. Jr., Elvove E.V., Additional studies of the relation of fluoride domestic waters to caries experience in 4,425 white children, aged 12-14 years, of 13 cities in 4 states. Public Health Rep. 1942;57:1155-79.

50. Black, G.V. Dent. Comos, 58:129, 1916.

51. Robbins v. Farmer’s Union Grain Terminal Ass’n. 552 F.2d 788,795 n. 15 (8th Cir. 1977) (“In a strict liability case we are talking about the condition (dangerousness) of an article sold without any warning, while in negligence we are talking about the reasonableness of the

manufacturer’s actions in selling the product without a warning. The article can have a degree of dangerousness because of a lack of warning which the law of strict liability will not tolerate even though the actions of the seller were entirely reasonable without a warning considering what he

knew or should have known at the time.”)

52. Restatement of Torts (Second), § 402A Special Liability of Seller of Product for Physical Harm to User or Consumer

53. See Law of Toxic Torts, §5 Duty to Warn, Michael Dore, 1994, Clark

54. Deluca v. Merrel-Dow Pharmaceuticals, Inc., 911 F.2d 941 (3rd Cir. 1990) defining relative risk in terms of exposed populations rather than exposed individuals. (“A relative risk of ‘two’ means that the disease occurs among the population subject to the event under investigation twice as frequently as the disease occurs among the population not subject to the event under investigation.”).

55. DRI Monograph, Defending Chemical Exposure Cases, 1,2, 1985.

56. Feldman v. Lederle Laboratories, 91 N.J. at 204, 447 A.2d at 546.

57. Manta, “Proximate Causation in Failure to Warn Cases: The plaintiff’s Achilles Heel,”26 For the Defense, lO, 11 (1984); Walker, “Proximate Cause in Failure to Warn Cases,” 31 For the Defense 23 (Oct. 1989): see, e.g., Cunningham v. Charles Pfizer & Co,, 532 P 2d 1377 (Okla. 1975) (We agree with defendant’s contention that as part of plaintiff’s cause of action plaintiff must establish that he would have refused to take the vaccine if adequate warning had been given”); see also Seley v. G.D. Searle & Co., 423 N.E.2d 831 (Ohio 1981); Gutwein v. Roche Laboratories, Prod. Liab. Rep. (CCH) ¶10, 429 (E.D.N.Y January 14, 1985) (under New York law in order to recover for an injurious side effect from a properly manufactured prescription drug plaintiffs must prove that the drug proximately caused the injury, that the manufacturer breached the duty to warn of the possibility of the injury, and that the breach proximately caused the injury”).

58. Modern Federal Practice Digest – Cumulative Supplement, 1972, A-I

59. National Interim Primary Drinking Water Regulations, EPA 570/9-76003.

60. Correspondence from Tudor Davies (Administrator, USEPA Office of Water) to George Glasser, June 1995.

61. Proceedings of a Joint IADR/ORCA International Symposium on Fluorides: Mechanisms of Action and Recommendations for Use, March 21-24, 1989, J. Dent. Research, Feb. 1990, vol. 69, Special Issue.

62. Proceedings Fourth Annual Conference of State Dental Directors with the Public Health Service and the Children’s Bureau, June68, 1951, Wash, DC.

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