Proposal 2-Concentration

WASHINGTON ACTION FOR SAFE WATER

August 16, 2010

Washington State Board of Health
Craig McLaughlin, Executive Director
Via e-mail:   McLaughlin, Craig D   (DOH) <Craig.McLaughlin@DOH.WA.GOV>

PETITION FOR RULE MAKING (#2): WATER FLUORIDATION
WAC 246-290-460

This petition relates to the concentration of fluoride, when fluoride is chosen to be added to drinking water.  In response to the question of the intent for fluoridation, the Board of Health responded, “This agency, therefore, is not in possession of any records related to the Board’s “purpose and intent for supporting the addition of fluoride to public drinking water.”[1] If the Board has no purpose or intent for supporting the addition of fluoride to public drinking water, then the Board should support a reduction of the recommended concentration of fluoride being added to drinking water.

The Board of Health also responded that target concentrations of fluoride in water were last revised in 1999.  The Board of Health also responded that “the Board complies with all state statutes” which should include statutes regarding the manufacturing of drugs added to public water.

Our June 9, 2010 petition requested the Board of Health to comply with state statues requiring manufacturers of drugs, in this case water suppliers, to be licensed and the drug approved by the Food and Drug Administration.  The Board of Health denied the petition, apparently because the Board believes it lacks authority to require fluoride drugs used in Washington State be FDA approved.  We disagree.  This new petition, however, provides discussion and evidence for the Board of Health to make an informed decision to lower the concentration of fluoride added to water.

Dental caries is a common disease and especially problematic for the young and poor.  Relying on a public health intervention which lacks efficacy, increases risks and wastes taxpayer dollars, is not good public policy.

I. PETITION TO IMPROVE AND PROTECT THE PUBLIC’S HEALTH WITH RULE MAKING ON FLUORIDATION (FLUORIDE ADDED TO PUBLIC DRINKING WATER)

 

This petition is made in the interest of a safer and healthier Washington.

The only intent of fluoridation is to prevent or mitigate dental caries, dental decay, and therefore fluoridation is defined as a drug by all drug regulatory agencies and laws.

In respect for the Board of Health’s time, this petition does not repeat many of the citations provided by the June 9, 2010 petition.   The supporting evidence for that petition which is in the Board’s possession should be reviewed for this petition.

The manufacturing of a substance with the intent to prevent disease, defined as a prescription drug by the Washington State Board of Pharmacy, unapproved by the FDA (Food and Drug Administration), defined as a drug by the FD&C Act and Washington Statutes, and dispensed to everyone without controlled dosage and without their consent must be closely and continuously reconsidered, controlled and monitored for safety, dosage, and efficacy.

This petition focuses on the concentration of fluoride added to public water and provides some of the evidence supporting the lowering of the current Board of Health recommended target concentrations.

II. WASHINGTON STATE BOARD OF HEALTH’S AUTHORITY TO REGULATE THE CONCENTRATION OF FLUORIDE ADDED TO PUBLIC WATER

The Washington State Board of Health should promulgate proper rules and regulations pertaining to fluoridation and should enforce such rules and regulations.  The Board “shall provide a forum for the development of public health policy in Washington state” and for over 10 years the Board does not appear to have provided a forum for the development of public health policy as it relates to fluoridation or the concentration of fluoridation.

Pursuant to RCW 43.20.50 (1) “The state board of health shall provide a forum for the development of public health policy in Washington state. . . .”  RCW 43.20.50 (2) “In order to protect public health, the state board of health shall: (a) Adopt rules for group A public water systems . . . necessary to assure safe and reliable public drinking water and to protect the public health.  Such rules shall establish requirements regarding : . . . (ii) Drinking water quality standards . . . (b) Adopt rules as necessary for group B public water systems . . .”  And further under RCW 70.142.010 to establish standards for chemical contaminants in public drinking water and “consider the best available scientific information establishing the standards.”

The Board of Health responded to the June 9 petition, without confidence or citation, “The Board does not appear to have authority to adopt rules related to a water district deciding whether to fluoridate.  The Board’s authority is to regulate allowable concentration levels and method of approval of water additives.”  (June 9, 2010 Board Meeting Handout, page 2).

The Board has the duty to protect the public health and assure safe public drinking water to both group A and B public water systems.  These petitioners disagree with the Board of Health’s initial opinion and for the health of the public and the cost to tax payers recommends the Board of Health more seriously consider this petition.   It is within the authority of the Board of Health to require water systems to obey drug laws when drugs are added to the water.   If a drug is not approved by the FDA, then it should be prohibited for use in water.   Certainly, a drug lacking FDA approval should not be forced on an entire public, entirely preventing a patient’s freedom of choice

This petition focuses on the undisputed jurisdiction of the Washington Board of Health to work for a safer and healthier Washington and regulate allowable concentration levels of the fluoridated water drug added to water.

This petition does not relate to naturally occurring fluoride, a contaminant, which is regulated by the EPA (Environmental Protection Administration).

The Board defers to the CDC (Centers for Disease Control) without citation for support of a safe range of fluoride concentration, 0.8 ppm to 1.3 ppm in WAC 246-290-460.[2]

The CDC clearly states:

“While it is not CDC’s responsibility to determine what levels of fluoride in water are safe, . . . .”[3]

The Board of Health errs when it relies on the CDC to determine what levels of fluoride in water are safe when the CDC clearly states that “it does not have responsibility to determine what levels of fluoride in water are safe.”  Congress has not given the CDC the authorization on which the Washington Board of Health depends.  Congress has given the Food and Drug Administration the responsibility to regulate the dosage of drugs.

The CDC suggests that:

“fluoridation remains the most equitable and cost-effective method of delivering fluoride to all members of most communities, regardless of age, educational attainment, or income level.”[4]

The CDC errs when suggesting fluoridation is equitable.  Fluoridation is not “equitable” for those choosing not to be fluoridated and is equitable only if freedom is discarded and ignored.  Equity is important for all patients, not a select subpopulation.  We do not give our consent to be fluoridated.

The CDC errs when suggesting fluoridation is the most cost effective method of delivering fluoride.  Delivering a pea size amount of toothpaste is more “cost-effective” than fluoridation and would provide freedom of choice for cohorts.

The CDC errs when it implies all members of a community should be targeted.  People without teeth in a fluoridated community do not benefit.  The potential target population for the ingestion of fluoride is ages 4 to 6.  Babies and toddlers do not benefit.  Older children and adults do not appear to benefit.

Forcing an unapproved drug on people does not educate them for good health habits of oral hygiene and nutrition which will mitigate dental decay and a host of other diseases.

Freedom for all should not be set aside in an attempt to treat a subpopulation with an unapproved drug, especially when it has little benefit.

III. INTENT OF USE

To determine the appropriate concentration of fluoride in water, the intent of use must be considered.  The intent of use determines the definition of a substance as it relates to regulatory agencies.  It appears the Board has not been provided a clear understanding of the difference between treating water and treating people.  If the intent of use is to treat water, the substance is regulated by the EPA.  If the intent of use is to treat people, the substance is regulated by the FDA.  The EPA also regulates contaminants added in excess of MCL.

If the substance is added with the intent to treat or prevent disease, the substance is defined as a drug and regulated by drug regulatory authorities for manufacturing, dispensing, administering and gaining individual consent. The evaluating of a contaminant in water is considerably different than evaluating a drug for the prevention of disease.

A. Assessment of Efficacy: Testing Water or Testing Patients

The assessment method for evaluating the success of an additive is to test or measure the water.

The assessment method for evaluating the success of a drug is to test or measure the disease in the patient.

In the case of an experimental unapproved drug such as fluoridation we must test the cohort for efficacy, reduction in dental caries, a reduction in dental treatment costs, and also test for safety with a lack of increase in adverse effects.    Fluoridation fails on all counts.  The current measured evidence for dental caries reduction is mixed and without confidence, measured dental treatment costs are not lower for all age groups in fluoridated communities, and measured adverse effects, such as dental fluorosis, are undisputed.

Adding a substance to water with the intent to kill pathogens in water and adding a substance to water with the intent to prevent disease in humans has different purposes, different regulatory agencies, different testing (assessment) practices, different levels of confidence for safety and efficacy, and different forms of consent.  There is little in common between an additive and a drug.

1.       TESTING WATER.  Substances mixed with water with the INTENT to disinfectant water, additives such as chlorine (bleach), are regulated by the EPA under the Safe Drinking Water Act.  A disinfectant is added to water at a recommended concentration and is tested by measuring the remaining pathogenic bacterial count in the water.  If there is a surge of contaminated water, additional chlorine maybe added to the system to ensure an adequate reduction in the bacteria and the water may be tested to ensure efficacy.   Knowing the substance can be toxic to both pathogens and humans, judgment is used to reduce the pathogens with the least harm to humans.

2.     TESTING PATIENTS. Manufacturing a substance with the INTENT to prevent disease, defined by the FD&C Act and RCW as a drug, is regulated by the FDA and Board of Pharmacy.  Before FDA approval of drugs, they are tested for efficacy and safety first in animals, then in small groups of humans and finally in larger groups of humans.   Randomized controlled trials to determine both efficacy and safety are required.  A good margin of safety is to be provided.  Pharmacokinetics is to be determined and documented.  A legend of warning and dosage is drafted and approved by the FDA.  Only after rigorous testing does the drug get approved by the FDA for use in humans.

Manufacturers are licensed and good manufacturing practices are required and monitored with oversight.  Until a drug has been approved, not only is the drug illegal, but dispensing the drug is considered experimental and must follow laws and ethics of human subject research.

When the Board of Health considers this petition, the Board of Health must look at the concentration of fluoride added to water through the eyes and judgment of the FDA and not the CDC or EPA.

B. Concentration versus Dosage

The concentration of a substance such as fluoride, arsenic or lead is usually measured in parts per million (ppm) or milligrams of the substance per liter (mg/L).

In contrast, the dosage of a drug is usually measured as milligrams of a drug per kilogram of body weight (mg/Kg bw) of the patient.  Putting a substance in public water and expecting a reasonably accurate dosage for the patient is problematic because at different ages the patient consumes different amounts of water based on their body size, such as infants on formula, and there is a significant variation in water consumption between patients of the same body weight.  Diabetics, laborers, and athletes often drink more water.  Concentration simply does not provide a reasonable dosage and can have a variation of more than ten fold.

C. Traditional Dosage of Fluoride (mg/Kg body weight).

To evaluate an appropriate concentration of fluoride in water, the Board of Health must first determine the desired dosage of fluoride for both efficacy and safety.  In this case, without a doctor’s supervision or the patient’s consent, the protective determination must include dosage of fluoride for subpopulations (each age group, gender, race, etc.) and include compromised medical conditions such as kidney dysfunction, intestinal disorders, iodine deficiencies etc.

The efficacy of fluoridation is disputed.  Perhaps due to the significant increases of fluoride from other sources, fluoridation no longer shows efficacy in decay reduction or reduction in dental expenses.  This is a good time for the Board to once again review the evidence on efficacy provided in the June 9 petition requesting fluoride drugs used be required to have FDA approval.

“Given the overlap among caries/fluorosis groups in mean fluoride intake and extreme variability in individual fluoride intakes, firmly recommending an “optimal” fluoride intake is problematic.”[5]

“The recommended optimal fluoride intake for children to maximize caries prevention and minimize the occurrence of dental fluorosis is often stated as being 0.05-0.07 mg/kg/day (Levy 1994; Heller et al. 1999, 2000).  Burt (1992) attempted to track down the origin of the estimate of 0.05-0.07 mg/kg/day as an optimum intake of fluoride but was unable to find it.” NRC 2006 p 68.

The so called “optimum” amount of fluoride is not based on scientific evidence or research but is simply a dental tradition, and ignorant of medical effects, an estimate which by default over time has been mistaken for fact.

The historically suggested optimal dosage of 0.05mg/Kg bw is excessive and without scientific support.   The FDA cautions not to swallow even a pea size amount of toothpaste, which contains 0.25 mg of fluoride.

As we progress in this petition, consider a 5 Kg child’s suggested “optimal” intake is 0.25 mg per day of fluoride, the same amount in a small pea size of toothpaste which the FDA warns not to swallow.  And 0.25 mg/L is more than 60 times the mean level of fluoride in mother’s milk.

The historical “optimal” amount is problematic.   None the less, the sea of numbers below will make more sense if the Board of Health remembers both 0.05 mg/Kg bw dosage as the suggested “optimal” amount of fluoride and 0.25 mg as the “do not swallow” total intake warning required by the FDA for toothpaste.

1. Fluoride is Not Essential for Health

Ingesting fluoride is not essential.  Fluoride has not been concluded essential for homeostasis or growth.[6] Many people, here and around the world, have excellent teeth without fluoride or fluoridated water.   Perhaps the optimal level should be 0.0 ppm.

“A re-examination of the pre-eruptive and post-eruptive mechanism of the anti-caries effects of fluoride: is there any anti-caries benefit from swallowing fluoride?”[7]

Freedom of choice must be given individuals to ingest or not ingest any substance which is not essential, not approved and highly toxic.

Careful brushing and flossing and a good diet can prevent dental caries and has the added benefit of reducing periodontal disease, heart disease, diabetes, obesity and more.

2. Fluoride Has Little Benefit, If Any.

Ingesting fluoride does not appear to reduce tooth decay.  Researchers are “puzzled”[8] at “The mystery of declining tooth decay”[9] in developed countries.  Comparing fluoridated with non-fluoridated countries, all developed countries have reduced tooth decay to similar levels.  Ranking states within the USA by the percent of whole population on fluoridated water finds no benefit from fluoridation.  Little or no cost savings in dental expenses have been achieved.

“An analysis of national survey data collected by the National Institute of Dental Research (NIDR) concludes that children who live in areas of the U.S. where the water supplies are fluoridated have tooth decay rates nearly identical with those who live in nonfluoridated areas”[10]

Some researchers suggest the “almost universal use of fluoridated toothpastes” has resulted in the decrease in tooth decay.[11]

Based on efficacy, the optimal concentration of fluoride in water is 0.0 ppm.

3.      Target Population

The target population for fluoridation, fluoride ingestion, is arguably ages 1 to 8, or ages 4 to 6, or about 3% to 10% of the population.    Remember, it is during growth spurts such as boys ages 4 to 6 on fluoridated water where we see an increase in osteosarcoma.

In brief, mother’s milk contains almost no fluoride, so unless a person is suggesting mother’s milk is “defective,” infants should not have fluoridated water to drink or contained in formulas.  Almost 40 years ago it was suggested fluoridated water provided 50 times more fluoride to infants.  20 years ago it was suggested fluoridated water gave 150 to 200 times more fluoride than mother’s milk.[12] Current studies find mother’s milk often has an undetected level of fluoride.

Toddlers should not drink more than one glass of fluoridated water (up to age 3).  After enamel has formed, age 6 to 8, fluoridated water has little or no theoretical or measured benefit.  Regardless of the disagreement of benefit for ages 1 to 8 or ages 4 to 6, only a small 3 to 10% of the population is targeted with potential benefit from fluoridated water.  Other methods of dispensing fluoride to this small segment of the population are available.  Protect the vulnerable and provide freedom of choice.

More details: Both the theoretical prevention of dental decay and the risk of dental fluorosis are during the development of tooth enamel. (See NRC Report 2006, p. 3, Chapter 3 and 4)  In other words, all the population, 100%, are being treated with fluoride in the community water but only a small fraction of the total might benefit.

1 ppm of fluoride when ingested in water is not considered high enough to have significant effect of fluoride incorporating into the enamel and the duration of contact time on the teeth during drinking is too short to have significant effect.

Saliva is very low in fluoride, similar to blood levels (0.019 mg/L see p 17 NRC report; and mother’s milk has been measured about 0.002-0.033 ppm[13]) and ingesting more fluoride does not appreciably alter the level of fluoride in the saliva.  Thus fluoridated water has perhaps a potential for benefit systemically during tooth enamel development, until about age 6-8.

The 1998 recommendation by the American Academy of Pediatrics suggested no prescription fluoride (supplements, additional fluoride) before age 6 months and one cup of water (0.25mg of F) 6 mo. to 3 years of age.[14]

The “typical child” up to 3 years of age drinks significantly more water than one glass a day (typical is 350 – 450 ml of water a day).   However, we should protect all children, not just the typical child and some children drink double the “typical child”.  In reality, the “typical child” should only consume about half the water they drink from fluoridated community water and the rest should be fluoride free (reverse osmosis, distilled or bottled water).  Can you imagine explaining that to busy moms, or try telling dads and care givers they need to keep track of total water intake and limit intake to one glass.  If Johnny is playing outside and thirsty, be sure to calculate how much water he has consumed and after about one glass of community water in soups, drinks, or foods, give him filtered water. Suppose Johnny has had his glass of water or mom runs out of bottled water and Johnny is still thirsty what should he drink, soda pop?  Of course not.

The City and Public Health Educators have failed to educate and warn parents and care givers of infants that the community water should be avoided for infants?  Parents have not been told that about half the water consumed by children up to the age of 3 should not be from community water.   These bottled water costs to families, plus the environmental impact of plastics and bottled water use, need to be factored in to the total expenses of fluoridation.

Only a small fraction of fluoridated water is used for drinking.  Of that, only a small fraction of people might benefit and measurements no longer detect significant measured benefit.  The concentration of fluoride in water should be protective of all, especially babies and those who are chemically sensitive or are unable to tolerate fluoride.

IV. CURRENT TOTAL EXPOSURE OF FLUORIDE

The World Health Organization advises communities to first determine the current exposure to fluoride before adding fluoride to water.  The Board of Health must determine individual current exposure and answer the question, “does the total fluoride exposure from all sources meet the desired dosage?”

“The major sources of internal exposure of individuals to fluorides are the diet (food, water, beverages) and fluoride-containing dental products (toothpaste, fluoride supplements). Internal exposure to fluorides also can occur from inhalation (cigarette smoke, industrial emissions), dermal absorption (from chemicals or pharmaceuticals), ingestion or parenteral administration of fluoride-containing drugs, and ingestion of fluoride-containing soil.” NRC 2006 p 19

A. For some, Fluoridated Water Alone Provides Excess Exposure

At 1 ppm fluoride, one liter of fluoridated water provides 1 mg of fluoride, four times the FDA warning and four times the suggested “optimal” amount for infants and 250 times the concentration of mother’s milk.

“Some subpopulations consume much greater quantities of water than the 2 L per day that EPA assumes for adults, including outdoor workers, athletes, and people with certain medical conditions, such as diabetes insipidus.” NRC 2006 P 23

And

“Average per capita ingestion of community or municipal water is estimated to be 927 mL/day (EPA 2000a; see Appendix B6). The estimated 90th percentile of the per capita ingestion of community water from that survey is 2.016 L/day. NRC 2006 P 23.

The Board of Health must be protective of everyone, 100%, not the 90th or 99th percentiles.  When the city uses police powers to medicate everyone, then the city is responsible for the dosage based on total exposure and concentration of fluoride in the water and risks from the fluoride for each individual.   If governments take someone’s property, the government pays for the property.  If governments take or damage an individual’s health, then governments should compensate those individuals.  At least fluoride free water should be provided those not wanting fluoridated water.

In Appendix B, Table B-4, page 376, the NRC 2006 lists water consumption at the 99th percentile with several groups close to 5 liters of water a day and one is 5.356 L/day.  At 1 ppm of fluoride, water alone for these people provides about 5 mg of fluoride per day, more than “optimal” from this source alone.

“The U.S. Army’s policy on fluid replacement for warm weather training calls for 0.5-1 quart/hour (0.47-0.95 L/hour), depending on the temperature, humidity, and type of work (Kolka et al. 2003; USASMA 2003). In addition, fluid intake is not to exceed 1.5 quarts/hour (1.4 liter/hour) or 12 quarts/day (11.4 L/day). The Army’s planning factor for individual tap water consumption ranges from 1.5 gallons/day (5.7 L/day) for temperate conditions to 3.0 gallons/day (11.4 L/day) for hot conditions (U.S. Army 1983).”[15]

11.4 L/day or 11.4 mg of fluoride a day which is about 3 times the “optimal” dosage and over 40 times above the FDA warning, “Do Not Swallow.”

“Someone initially presenting with central or vasopressin-sensitive diabetes insipidus might ingest “enormous” quantities of fluid and may produce 3-30 L of very dilute urine per day (Beers and Berkow 1999) or up to 400 mL/kg/day (Baylis and Cheetham 1998). Most patients with central diabetes insipidus have urine volumes of 6-12 L/day (Robinson and Verbalis 2002).”[16]

Diabetics may ingest 12 liters/day or 12 mg per day of fluoride from water alone.  When determining the concentration of fluoride added to water, the Board of Health has a duty to protect the health and safety of everyone, not just the mean.

“Moderate and severe dental fluorosis have been reported in diabetes insipidus patients in other countries with drinking water containing fluoride at 0.5 mg/L (Klein 1975) or 1 mg/L (Seow and Thomsett 1994), and severe dental fluorosis with skeletal fluorosis has been reported with fluoride at 3.4 mg/L (Mehta et al. 1998). Greenberg et al. (1974) recommended that children with any disorder that gives rise to polydipsia and polyuria9 be supplied a portion of their water from a nonfluoridated source.”[17]

Anyone suggesting the NRC report does not have critical information for those evaluating fluoridated water concentrations and safety has not read the report.  The report does not deal with efficacy, but it has valuable information on risk.   Since the mid 1970’s moderate and severe dental fluorosis, a sign of fluoride toxicity, has been reported at 0.5 mg/L and 1 mg/L fluoride in water.

It would be best for the Board of Health to lower the concentration of fluoride in water rather than have water districts supply a secondary source of fluoride-free water for babies, children, the military, prisoners, diabetics, those chemically sensitive and those refusing to give consent.

Many are ingesting too much fluoride from water alone.

B. Fluoride Exposure From Food

Many are ingesting too much fluoride from food alone.

The National Research Council report for the EPA on fluoride in drinking water provides a glimpse of fluoride in various foods.  Here are a few examples which become a concern when the total fluoride exposure is considered.  Remember 0.05 mg/Kg bw suggested “optimal” and 0.25 mg FDA warning.

The purpose of this section is for the Board of Health to understand some of the various sources of fluoride exposure and thus support for lowering the concentration of fluoride in water as requested in this petition.

“Measured fluoride in samples of human breast milk is very low. Dabeka et al. (1986) found detectable concentrations in only 92 of 210 samples (44%) obtained in Canada, with fluoride ranging from <0.004 to 0.097 mg/L.” NRC p 26

The purpose of that quotation is for the Board of Health to understand the fluoride concentration of mother’s milk was not detected in more than half of the cohorts.  If the Board of Health intends to protect the health of babies, based on mother’s milk, the low end of the concentration of fluoride added to water should be 0.00 ppm.

“Heilman et al. (1997) found 0.01 to 8.38 ?g of fluoride per g of prepared infant foods.  The highest concentrations were found in chicken (1.05-8.38 ?g/g); other meats varied from 0.01m?g/g (veal) to 0.66 ?g/g (turkey). Other foods—fruits, desserts, vegetables, mixed foods, and cereals—ranged from 0.01 to 0.63 ?g/g. The fluoride concentrations in most foods are attributable primarily to the water used in processing (Heilman et al. 1997); fluoride in chicken is due to processing methods (mechanical deboning) that leave skin and residual bone particles in the meat (Heilman et al. 1997; Fein and Cerklewski 2001). An infant consuming 2 oz (about 60 g) of chicken daily at 8 ?g of fluoride per g would have an intake of about 0.48 mg (Heilman et al. 1997).” NRC p 30

The one serving of chicken would be the entire daily dose of fluoride for a 22 pound child even without any other fluoride from water, toothpaste, or other foods.  And it would be double the FDA’s warning, not to swallow.

“ Fluoride concentrations in tea leaves range from 170 to 878 mg/kg in different types of tea, with brick tea generally having 2-4 times as much fluoride as leaf tea (Wong et al. 2003).” NRC 2006 p 31.

“Whyte et al. (2005) reported fluoride concentrations of 1.0-6.5 mg/L in commercial teas (caffeinated and decaffeinated) obtained in St. Louis (prepared with distilled water according to label directions).” NRC 2006 p 31.

“Kiritsy et al. (1996) reported fluoride concentrations in juices and juice-flavored drinks of 0.02-2.8 mg/L (mean, 0.56 mg/L) for 532 different drinks (including five teas) purchased in Iowa City (although many drinks represented national or international distribution); frozen-concentrated beverages were reconstituted with distilled water before analysis. White grape juices had the highest mean fluoride concentration (1.45 mg/L); upper limits on most kinds of juices exceeded 1.50 mg/L . . . . The high fluoride content of grape juices (and grapes, raisins, and wines), even when little or no manufacturing water is involved, is thought to be due to a pesticide (cryolite) used in grape growing (Stannard et al. 1991; Kiritsy et al. 1996; Burgstahler and Robinson 1997).” NRC 2006 p 31.

“R.D. Jackson et al. (2002) reported . . .  mean daily fluoride ingestion for children 3-5 years old from food and beverages (including those prepared with community water) was estimated to be 0.454 mg in the low-fluoride town and 0.536 mg in the fluoridated town.” NRC 2006 p 32.

C. SULFURYL FLUORIDE: POST-HARVEST FUMIGANT

After foods have been harvested, they must rapidly get to market and have a long shelf life.  In the past bromine gas was used as a post-harvest fumigant to preserve the foods, but bromine apparently has been discontinued due to environmental concerns.  Sulfuryl fluoride is replacing the bromine.

The advertisement for ProFume gas (DowAgro Science) with a good looking cookie below:

should be tempered with the warning label below:

The fluoride residue permitted on foods is significant and can increase the total fluoride exposure.  DowAgroSciences, LLC, is confident not all of the foods will have the maximum fluoride permitted residues.  Here are a few of the many foods which have permitted fluoride residue concentrations of fluoride:

Fig, plum, prune,  grape, raisin, fruit 5 ppm

Almond, barly grain, rice grain 10 ppm

Pecan 23 ppm

Walnut 30 ppm

Wheat grain 25 ppm

Wheat germ 98 ppm

Refined oil 3 ppm

Egg 850 ppm

Dried egg 900 ppm

D. Fluoride Exposure In Dental Products and Supplements

The FDA is concerned that 0.25 mg of fluoride is too much to swallow.  The FDA required toothpaste warning is not to swallow a pea size amount.  A pea size of toothpaste contains 0.25 mg of fluoride, the same amount as one glass of fluoridated water.  If the FDA warns not to swallow 0.25 mg of fluoride, the Board of Health should not force everyone to swallow that much in each glass of water.

“More than 90% of children ages 2-16 years surveyed in 1983 or 1986 used fluoride toothpaste (Wagener et al. 1992). Of these children, as many as 15% to 20% in some age groups also used fluoride supplements or mouth rinses (Wagener et al. 1992). Using the same 1986 survey data, Nourjah et al. (1994) reported that most children younger than 2 years of age used fluoride dentifrices.” NRC 2006 p 34.

“Ophaug et al. (1980, 1985) estimated the intake of fluoride by small children (2-4 years) to be 0.125-0.3 mg per brushing; a 2-year-old child brushing twice daily would ingest nearly as much fluoride from the toothpaste as from food and fluoridated drinking water combined (Ophaug et al. 1985).” NRC 2006 p 34.

The Board of Health should once again remember that when fluoridated water was initially recommended at 1 ppm, fluoridated dental products such as fluoridated toothpaste were not available and the concentration of fluoride in water was considered the only significant and common source of fluoride.

“Levy (1993, 1994) and Levy et al. (1995a) reviewed a number of studies of the amount of toothpaste people of various ages ingest. Amounts of toothpaste used per brushing range from 0.2 to 5 g, with means around 0.4-2 g, depending on the age of the person. The estimated mean percentage of toothpaste ingested ranges from 3% in adults to 65% in 2-year-olds. Children who did not rinse after toothbrushing ingested 75% more toothpaste than those who rinsed. Perhaps 20% of children have fluoride intakes from toothpaste several times greater than the mean values, and some children probably get more than the recommended amount of fluoride from toothpaste alone, apart from food and beverages (Levy 1993, 1994). Mean intakes of toothpaste by adults were measured at 0.04 g per brushing (0.04 mg of fluoride per brushing for toothpaste with 0.1% fluoride), with the 90th percentile at 0.12 g of toothpaste (0.12 mg of fluoride) per brushing (Barnhart et al. 1974).

Lewis and Limeback (1996) estimated the daily intake of fluoride from dentifrice (products for home use) to be 0.02-0.06, 0.008-0.02, 0.0025, and 0.001 mg/kg, for ages 7 months to 4 years, 5-11 years, 12-19 years, and 20+ years, respectively.” NRC 2006 p 34

“Topical applications of fluoride in a professional setting can lead to ingestion of 1.3-31.2 mg (Levy and Zarei-M 1991) . . . Eklund et al. (2000), in a survey of insurance claims for more than 15,000 Michigan children treated by 1,556 different dentists, found no association between the frequency of use of topical fluoride (professionally applied) and restorative care. Although these were largely low-risk children, for whom routine use of professionally applied fluoride is not recommended, two-thirds received topical fluoride at nearly every office visit. The authors recommended that the effectiveness of professionally applied topical fluoride products in modern clinical practice be evaluated.” NRC 2006 p 35.

The lack of a reduction in dental expenses with the topical application of fluoride, is an example of never letting good research stand in the way of a profitable practice.

“The dietary fluoride supplement schedule in the United States, as revised in 1994 by the American Dental Association, now calls for no supplements for children less than 6 months old and none for any child whose water contains at least 0.6 mg/L (Record et al. 2000; ADA 2005; Table 2-8). Further changes in recommendations for fluoride supplements have been suggested (Fomon and Ekstrand 1999; Newbrun 1999; Fomon et al. 2000), including dosages based on individual body weight rather than age (Adair 1999) and the use of lozenges to be sucked rather than tablets to be swallowed (Newbrun 1999), although others disagree (Moss 1999). The Canadian recommendations for fluoride supplementation include an algorithm for determining the appropriateness for a given child and then a schedule of doses; no supplementation is recommended for children whose water contains at least 0.3 mg/L or who are less than 6 months old (Limeback et al. 1998; Limeback 1999b).” NRC 2006 p 35

Reducing the concentration of fluoride to 0.6 ppm would be in keeping with 16 year old data from the American Dental Association.  A reduction to 0.3 ppm would be in keeping with Canadian recommendations.  However, most European Dental Associations no longer recommend fluoride supplements which would put the low level of a range of fluoridation at 0.00ppm.

E.        Fluoride From Air

“For most individuals in the United States, exposure to airborne fluoride is expected to be low compared with ingested fluoride (EPA 1988); exceptions include people in heavily industrialized areas or having occupational exposure.” NRC 2006 p 37

F.        Fluoride from Soil

“Erdal and Buchanan (2005) estimated intakes of 0.0025 and 0.01 mg/kg/day for children (3-5 years), for mean and reasonable maximum exposures, respectively, based on a fluoride concentration in soil of 430 ppm. . . .

For children with pica (a condition characterized by consumption of nonfood items such as dirt or clay), an estimated value for soil ingestion is 10 g/day (EPA 1997). For a 20-kg child with pica, the fluoride intake from soil containing fluoride at 400 ppm would be 4 mg/day or 0.2 mg/kg/day. Although pica in general is not uncommon among children, the prevalence is not known (EPA 1997).” NRC 2006 p 38

G.     Fluoride from Pesticides

“Cryolite and sulfuryl fluoride are the two pesticides that are regulated for their contribution to the residue of inorganic fluoride in foods. . . . Cryolite, sodium hexafluoroaluminate (Na3AlF6), is a broad spectrum insecticide that has been registered for use in the United States since 1957. Currently, it is used on many food (tree fruits, berries, and vegetables) and feed crops, and on nonfood ornamental plants (EPA 1996a).

The respective fluoride ion concentrations from a 200 ppm aqueous synthetic cryolite (97.3% pure) at pH 5, 7, and 9 are estimated at 16.8, 40.0, and 47.0 ppm (approximately 15.5%, 37%, and 43% of the total available fluorine) (EPA 1996a). . .

The dietary fluoride exposure thus estimated ranged from 0.0003 to 0.0031 mg/kg/day from cryolite, 0.0003 to 0.0013 mg/kg/day from sulfuryl fluoride, and 0.005 to 0.0175 mg/kg/day from background concentration in foods (EPA 2004).” NRC 2006 p 40.

H.        Fluoride From Fluorinated Organic Compounds.

“Many pharmaceuticals, consumer products, and pesticides contain organic fluorine (e.g., –CF3, –SCF3, –OCF3).  . . .

Pradhan et al. (1995) reported an increased serum fluoride concentration from 4 ?M (0.076 ppm) to 11 ?M (0.21 ppm) in 19 children from India (8 months to 13 years old) within 12 hours after the initial oral dose of ciprofloxacin at 15-25 mg/kg. . . .

Other fluoride-containing organic chemicals go through more extensive metabolism that results in greater increased bioavailability of fluoride ion. . . .

Levy et al. (2001a) reported less than 3% systemic fluorouracil absorption in patients treated with 0.5% or 5% cream for actinic keratosis.

A group of widely used consumer products is the fluorinated telomers and

polytetrafluoroethylene, or Teflon. EPA is in the process of evaluating the environmental exposure to low concentrations of perfluorooctanoic acid (PFOA) and its principal salts that are used in manufacturing fluoropolymers or as their breakdown products (EPA 2003b). PFOA is persistent in the environment.” NRC 2006 p. 41.

I. Fluoride From Aluminofluorides

“Human exposure to aluminofluorides can occur when a person ingests both a fluoride source (e.g., fluoride in drinking water) and an aluminum source; sources of human exposure to aluminum include drinking water, tea, food residues, infant formula, aluminum-containing antacids or medications, deodorants, cosmetics, and glassware (ATSDR 1999; Strunecka and Patocka 2002; Li 2003; Shu et al. 2003; Wong et al. 2003).  Aluminum in drinking water comes both from the alum used as a flocculant or coagulant in water treatment and from leaching of aluminum into natural water by acid rain (ATSDR 1999; Li 2003). Exposure specifically to aluminofluoride complexes is not the issue so much as the fact that humans are routinely exposed to both elements.” NRC 2006 p 42.

J.      Fluoride From Fluorosilicates

“Most fluoride in drinking water is added in the form of fluosilicic acid (fluorosilicic acid, H2SiF6) or the sodium salt (sodium fluosilicate, Na2SiF6), collectively referred to as fluorosilicates (CDC 1993). Of approximately 10,000 fluoridated water systems included in the CDC’s 1992 fluoridation census, 75% of them (accounting for 90% of the people served) used fluorosilicates. This widespread use of silicofluorides has raised concerns on at least two levels.

First, some authors have reported an association between the use of silicofluorides in community water and elevated blood concentrations of lead in children (Masters and Coplan 1999; Masters et al. 2000); this association is attributed to increased uptake of lead (from whatever source) due to incompletely dissociated silicofluorides remaining in the drinking water (Masters and Coplan 1999; Masters et al. 2000) or to increased leaching of lead into drinking water in systems that use chloramines (instead of chlorine as a disinfectant) and silicofluorides (Allegood 2005; Clabby 2005; Maas et al. 2005).” NRC 2006 p 43

V. DETERMINING FLUORIDE CONCENTRATION FOR WATER.

Although the precautionary principle may not be codified, certainly the Board of Health should be cautious.  The Board should follow the Safe Drinking Water Act and the Food, Drug and Cosmetic Act when considering the safety and risks of fluoridation.

“Due to misdirection by EPA management, who requested the report, the NRC committee identified only health effects known with total certainty. This is contrary to the intent of the Safe Drinking Water Act (SDWA), which requires the EPA to determine “whether any adverse effects can be reasonably anticipated, even though not proved to exist.” Further misdirection by EPA consisted of instructing the committee not to identify a new MCLG—in other words, not to determine a safe level of fluoride in drinking water, and not to discuss silicofluorides, phosphate fertilizer manufacturing by-products used in most cities to fluoridate their water. Despite these restrictions, the committee broke new ground . . . On the basis of this information and the proper interpretation of the SDWA, the following are all adverse health effects: moderate dental fluorosis, stage I skeletal fluorosis (arthritis with joint pain and stiffness), decreased thyroid function, and detrimental effects on the brain, especially in conjunction with aluminum. The amount of fluoride necessary to cause these effects to susceptible members of the population is at or below the dose received from current levels of fluoride recommended for water fluoridation. The recommended Maximum Contaminant Level Goal (MCLG) for fluoride in drinking water should be zero[18]

Different methods for determining the appropriate concentration of fluoride can be used.  When used with the intent to prevent tooth decay, fluoride is a drug and concentration should be evaluated with the same criteria used by the Food and Drug Administration. The FDA New Drug Application criteria, includes:

    1. Labeling
    2. Chemistry
    3. Nonclinical pharmacology and toxicology
    4. Human pharmacokinetics and bioavailability
    5. Clinical microbiology
    6. Clinical data
    7. Safety update
    8. Statistical section
    9. Case Report Tabulations
    10. Case Report Forms
    11. Establishment description
    12. Debarment certification
    13. Field copy certification

The expense and time to develop protocol and pay experts to evaluate all those aspects of the fluoride drug seems to be a misuse of tax payer money.  Certainly the Board should reconsider requiring water districts to use the services of the FDA (June 9, 2010 WASW Petition) rather than the Board taking on the responsibility of drug approval for one drug.

For example, the CDC and several state departments of health caution, “Recent studies have raised the possibility that mixing infant formula with fluoridated water, particularly for infants exclusively on a formula diet during the first year of life, may play a more important role in enamel fluorosis development than was previously understood.”

A. Mother’s Milk:

The simplest and most powerful evidence to consider for the concentration of fluoride in water for babies is mother’s milk.  We must protect babies, our most vulnerable. 

Mother’s milk has a range of between “not detected and 0.10 ppm (100ppb) and should be the concentration range approved by the Board of Health.    In non-fluoridated communities the mean level of fluoride in mother’s milk was found to be 0.004 ppm.   Based on mother’s milk, a range of fluoride selected by the Board should be of 0.004 ppm (4 ppb) to 0. 10ppm (100 ppb).

Historical estimates suggested 0.05 mg/Kg/day of fluoride was “optimal.”  Infants often exceed the “optimal” amount of fluoride.

“For water from all sources (direct, mixed with formula, etc.), the intake of fluoride by infants (Levy et al. 1995b) ranged from 0 (all ages examined) to as high as 1.73 mg/day (9 months old).  . . . For ages 1.5-9  months, approximately 40% of the infants exceeded a mass-normalized intake level for fluoride of 0.07 mg/kg/day; for ages 12-36 months, about 10-17% exceeded that level (Levy et al. 2001b).”  NRC 2006.

At least 40% of Infants to 9 months are ingesting too much fluoride and 10-17% up to age 36 months are ingesting too much fluoride.

B. Efficacy:

Calculating an effective dose is more controversial.  Without the FDA using their criteria for drug approval, some of the best evidence no longer shows efficacy from ingesting fluoride.

Measuring the costs to treat dental disease is a reasonable method for evaluating efficacy.  Dental treatment costs include the possibility of a reduction in dental decay and possible adverse events such as increased tooth fractures and what clinicians call “fluoride bombs” and treatments for dental fluorosis.   Only one published study uses measured data of dental treatment costs and it found almost no difference between the fluoridated and non-fluoridated communities with an increase in dental costs for children in the largest fluoridated community. Historical studies did not find a reduction in dental expense.  Only when authors make assumptions and estimates of those assumptions does fluoridation look good.

Dental decay rates are similar in communities with or without fluoridation.  Perhaps total exposure has risen to the point that additional fluoride from water is no longer beneficial or perhaps ingestion of fluoride does not reduce dental decay.  Because decay rates are similar regardless of fluoridated water, the Board should put most emphasis on safety and cost when determining fluoridation concentration.

C. Safety Concentration:

To determine the “safe” concentration of fluoride in water:

1) Identify the most sensitive end point (adverse health effect).

a.         0.5 ppm Fluoride in water for diabetics (Klein 1975)  and 1 ppm (Seow and Thomsett 1994),

b.         1.0 ppm Fluoride in water for Osteosarcoma (Bassin 2006[19], Sandhu 2009[20])

c.         0.7 ppm Fluoride in water for Hip Fractures (Diesendorf 1997)[21]

d.         0.0 ppm Even without the addition of fluoride in water, dental fluorosis, a biomarker of excess fluoride ingestion occurs in about 1 out of 5 children.   That means, one in five are ingesting too much fluoride even without fluoridation.  Fluoridation increases dental fluorosis risk to 1 in 3 children.

e.         0.8 ppm finds increased risk of neurotoxicity, severe dental fluorosis, stage II skeletal fluorosis, impaired glucose metabolism, impaired thyroid function and moderate dental fluorosis. (Thiessen)

The Board must not glide over the above concentration and disease.  Measured increases of disease indicate water has too much fluoride concentration and current levels are not protective for high risk individuals.

2) To protect high risk individuals, one must determine the lowest dose which causes that health effect in a human study, which is 0.5 ppm diabetes, 0.7 ppm hip fractures, 0.8 ppm neurotoxicity, severe dental fluorosis, stage II skeletal fluorosis, impaired glucose metabolism, impaired thyroid function and moderate dental fluorosis (LOAEL, lowest observed effect level often defined as an adverse alteration of morphology, function, capacity, growth, development).

3) Divide the known risk by a safety factor (usually 10) in order to cover the range of sensitivity expected in any human population.  The maximum concentration of fluoride added to water should not exceed 0.05 ppm.

0.0 ppm to 0.08 ppm of fluoride is also the concentration of fluoride found in most mothers’ milk.

In deference to the Board’s opinion that they cannot abide by the FD&C Act, the lowest level of 0.001 ppm or 1ppb is recommended in this petition.  And the upper level of 0.08 ppm or 80 ppb is recommended.  Fluoridation concentration target of 0.05 ppm, in keeping with scientific evidence on total dosage, efficacy and safety.

VI. PETITION FOR WAC CHANGES: SUGGESTED WORDING

The proposed WAC changes do not affect the roughly 40 chemicals which may be added to treat water contaminants, odors, turbidity, or pathogens, in other words to make water safe and potable.

The suggested WAC changes are as follows in red and italics:

“WAC 246-290-460

(2) Where fluoridation is practiced, purveyors shall maintain fluoride concentrations in the range 0.001 through 0.08 mg/L 0.8 through 1.3 mg/L throughout the distribution system.

(3) Where fluoridation is practiced, purveyors shall take the following actions to ensure that concentrations remain at optimal levels and that fluoridation facilities and monitoring equipment are operating properly: . . . “

(iv) If a split sample is found by the certified lab to be:

(A) Not within the range 0.001 through 0.08 mg/L of 0.8 to 1.3 mg/l, the purveyor’s fluoridation process shall be considered out of compliance.”

Should the Board want additional citations, we would be pleased to provide them.

Sincerely Yours,

Bill Osmunson DDS, MPH
Washington Action for Safe Water
1418 – 112th Ave NE 200
Bellevue, WA 98004
425.455.2424


[1] July 22, 2010 letter to Bill Osmunson regarding public information disclosure request.

[2] Washington State Board of Health meeting handout, June 9, 2010, page 2

[3] http://www.cdc.gov/fluoridation/safety.htm

[4] CDC, MMWR October 22, 1999 Vol. 48 No.41

[5] Warren J, Levy S, Froffitt B, Cavanaugh J, Kanellis M, Weber-Gasparoni K, Considerations on Optimal Fluoride Intake Using Dental Fluorosis and Dental Caries Outcomes- A Longitudinal Study, JPHD 2008

[6]Department of Health and Human Services, Review of Fluoride, Benefits and Risks, Report of the Ad Hoc Subcommittee on Fluoride of the Committee to Coordinate Environmental Health and Related Programs, Public Health Service. P 7.  “there is no conclusive evidence that fluorine or any of the fluoride compounds are essential for human homeostasis or growth (McIvor et al., 1985).”

[7] Limeback H, Community Dental Oral Epidemiology 1999 Feb;27(1):62-71

[8] Pizzo G, Piscopo MR, Pizzo I, Giuliana G, Community water fluoridation and caries prevention: a critical review, Clin Oral INvestig Sept 2007

[9] Mark Diesendorf, Nature 1986, page 125

[10] Chemical and Engineering News, May 8, 1989, Vol 57, Number 19.

[11] Featherstone John, Nutrition Today, 1987

[12] Ekstrand Jan, Fluoride Intake in Early Infancy, The Journal of Nutrition 119: 1856-1860, 1989.

[13] NRC p. 30.  “Hossny et al. (2003) reported fluoride concentrations in breast milk of 60 mothers in Cairo, Egypt, ranging from 0.002 to 0.01 mg/L [0.1-0.6 ?M/L; median, 0.0032 mg/L (0.17 ?M/L); mean, 0.0046 mg/L (0.24 ?M/L)]. Cairo is considered nonfluoridated, with a reported water fluoride concentration of 0.3 mg/L (Hossny et al. 2003). Opinya et al. (1991) found higher fluoride concentrations in mothers’ milk (mean, 0.033 mg/L; range, 0.011-0.073 mg/L), but her study population was made up of mothers in Kenya with an average daily fluoride intake of 22.1 mg. However, even at very high fluoride intakes by mothers, breast milk still contains very low concentrations of fluoride compared with other dietary fluoride sources. No significant correlation was established between the fluoride in milk and the intake of fluoride in the Kenyan study.” (Opinya et al. 1991).

[14] Pediatrics May 1998 Vol. 95, Number 5   RE9511

[15] NRC 2006 p 26.

[16] NRC 2006 p 26

[17] NRC 2006 p 27

[18] Carton, R Review of the 2006 United Stat4es National Research Council Report: Fluoride in Drinking Water, Fluoride 39(3)163-172 Jul-Sep 2006.  http://www.fluorideresearch.org/393/files/FJ2006_v39_n3_p163-172.pdf

[19] Bassin E, Wypij D, Davis R, Mittleman M, Age-specific fluoride exposure in drinking water and osteosarcoma (United States), Cancer Causes Control (2006) 17:421-428.

[20] Sandhu R, Lal H, Kundu Z, Karb S, Serum Fluoride and Sialic Acid Levels in Osteosarcoma, Bio Trace Elem Res, DOI 10.1007/s12011-009-8382-1

[21] Diesendorf M, Colquhoun J, Spittle B, New Evidence on Fluoridation, Australian and New Zealand Journal of Public Health, 1997, 21 (2): 187-190

  1. March 28th, 2012 at 23:21 | #1

    When calculating the fluoride to be added in the water. the mean weight of infants,and schildren up to age 5years should be considered as these are the most vulnerable to to growth and development. But the mean infant weight for age should be the most critical as chronic fluoride toxity is dependent on mg/Kg of fluoride on body weight. Also all the othe source of fluoride to the infant should be considered

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