by Paul Connett
Testing by the National Sanitation Foundation (NSF) International suggests that the levels of arsenic in these chemicals, after dilution into public water, can be as high as 1. 66 ppb (parts per billion) and are of potential concern. 5, 6 The current safe drinking water standard (alias the maximum contaminant level, or MCL) for arsenic is 10 ppb, and the American Water Works Association (AWWA) does not permit chemicals in the water to reach one-tenth of that standard. Clearly, fluoride is an exception to the rule, since AWWA allows and supports the addition of fluoride at 1 ppm, even though the MCL for fluoride is 4 ppm.
Moreover, as far as regulatory standards are concerned, it should be remembered that a number of water standards for contaminants are set at compromise levels. To determine the federally enforceable standard (i. e. , the MCL), considerations of the cost of removal are set against an ideal safety goal (the MCLG, or maximum contaminant level goal). The MCLG for arsenic is set at zero, while the MCL is 10 ppb. Although it can be appreciated that a compromise has to be reached when considering how much money it costs to remove a naturally occurring contaminant like arsenic, it is more difficult to justify the deliberate addition of any level of arsenic to the drinking water, as occurs when industrial-grade fluoridating agents are used, thereby exceeding arsenic’s MCLG of zero.
The EPA sets the MCLG for arsenic at zero because arsenic is known to be a human carcinogen, and for the EPA there is no safe consumption level for a cancer-causing chemical. By allowing the use of arsenic-contaminated fluoridating chemicals, we are sanctioning an increased cancer risk for the whole population in an effort to reduce tooth decay by a small amount. Most people are unaware that that is the trade-off that has been made.
The lack of oversight of the fluoridation program by the FDA partially explains why the chemicals used have not been tested in their pure, let alone their contaminated, form. The chemical usually tested in animal studies is pharmaceutical-grade sodium fluoride, not industrial-grade hexafluorosilicic acid. When the switch was made from sodium fluoride to the silicon fluorides (either hexafluorosilicic acid or its sodium salt), the crude assumption was made that, once it was diluted and the solution brought to a neutral pH, a solution of hexafluorosilicic acid would be equivalent in all respects to a solution of sodium fluoride. This assumed two things: (1) that hexafluorosilicic acid completely dissociated to free fluoride ions, hydrogen ions, and hydrated silica; and (2) that the presence of hydrated silica would have negligible significance. The notion of complete dissociation was based on theoretical calculations, not on real-life testing. This reasoning also neglects the possibility that the hexafluorosilicate ion (or some other silicon-fluoride species) might be reformed in the acidic conditions of the stomach (see the next section).
The Chemistry and Toxicology of Artificially Fluoridated Water
Before we embark on this discussion, it is important to stress that there is plenty of evidence (particularly from India and China) that moderate to high levels of natural fluoride in water cause a litany of health problems (see chapters 14–19). Just because a substance appears naturally in water does not mean the water is safe to drink. Arsenic, for example, occurs naturally in water, but it is highly toxic, and some communities are spending a lot of money removing it to meet regulatory standards.
The possible difference between the biological effects of free fluoride ions and the biological effects of silicon fluorides has been the subject of a lively debate between Coplan and Masters on the one hand and Urbansky and Schock on the other. The recent debate was sparked when studies by Masters et al. reported an association between the use of fluorosilicic acid (or its sodium salt) to fluoridate water and an increased uptake of lead into children’s blood. 7, 8 They did not find the association when sodium fluoride was used, and they hypothesized that the silicon fluorides facilitated the uptake of lead present in the stomach (from any other environmental source) into the child’s bloodstream. Because of lead’s acknowledged ability to damage a child’s developing brain, this is a very serious finding, yet it is being largely ignored by fluoridating countries. See the next section, “Fluoridating Agents and Lead, ” for a discussion of corroborating findings in a 2010 animal study.
Urbansky and Schock have argued on theoretical grounds that with the dilutions used in fluoridation, the dissociation of the silicon fluorides would be complete. 9, 10 The EPA financed a research study at the University of Michigan to investigate the dissociation of hexafluorosilicic acid at high dilution. The authors reported that at pH 7 the dissociation was virtually complete, but that at pH 3 most of the fluoride appeared in a silicon-fluoride complex containing five bound fluoride ions. 11 This raises the question of whether, when the hydrated silicon and fluoride ions enter the stomach at pH 1–2, they recombine to form this complex, resulting in a species with different chemical and biological properties from those of a bare fluoride ion.
Fluoridating Agents and Lead
A recent study by Maas et al. indicates that fluoridating chemicals alone, and in conjunction with other chemicals added to water (such as chloramine), have the ability to increase the leaching of lead from brass fittings. 12 Also, Masters and Coplan’s suggestion that hexafluorosilicic acid increases uptake of lead into children’s blood received strong support from an important animal study performed by researchers from Brazil and published in the April 2010 edition of the journal Toxicology. 13
In that study the authors designed an animal experiment to see whether Masters and Coplan’s hypothesis was biologically feasible. They investigated whether fluoride (as hexafluorosilicic acid) co-administered with lead increased the uptake of lead into blood and calcified tissues in rats, over lead administered alone. Blood lead concentrations over three times higher were found in the rats exposed to fluoride plus lead compared with those exposed to lead only, and the difference was statistically significant (p<0. 001* ).
Lead concentrations were found to be 2. 5 times higher in the superficial enamel, 3 times higher in surface bone, 2 times higher in whole bone, and 1. 7 times higher in the dentine when the animals were co-exposed to fluoride.
The authors concluded, “These findings show that fluoride consistently increases blood lead and calcified tissues lead concentrations in animals exposed to low levels of lead and suggest that a biological effect not yet recognized may underlie the epidemiological association between increased blood lead levels in children living in water-fluoridated communities. ”14 In essence, these authors have provided a well-designed animal study that supports the epidemiological findings of Masters and Coplan15 and Masters et al. 16
It is well established that even very low levels of lead exposure can compromise the intellectual development and behavior of young children. If, as this experiment shows in animals and Masters and Coplan may have found in epidemiological studies, lead exposure is increased by the presence of hexafluorosilicic acid (or possibly even free fluoride ions) in drinking water, this should result in the end of fluoridation in any rational world.
Fluoridating Chemicals from China
As a result of the decreased availability of fluoridating chemicals in the United States, some communities have been using fluoridating agents imported from China: either sodium fluoride or sodium silicofluoride (i. e. , sodium hexafluorosilicate). Both of these can be shipped as solids, but, according to recent press reports, some water departments have been unable to completely dissolve the sodium fluoride received from China. They are left with an unidentified sludge. Even though the substance has not been identified, a CDC engineer has said that it is safe. 17 In one case this problem has forced a town to stop fluoridating. 18
Summary
Promoters of fluoridation claim that they are simply topping off the existing natural concentration of fluoride in the water supply to a supposed optimal level of around 1 ppm. However, it is not quite so simple as that. The chemicals used in most fluoridation programs—silicon fluorides obtained from the phosphate fertilizer industry—are not naturally occurring f
luoride compounds or the pharmaceutical-grade substances used in dental products. They are derived from wet-scrubbing systems, contain other contaminants, and are officially characterized as hazardous waste by the U. S. EPA. Over 90 percent of the chemicals used in the U. S. fluoridation programs are silicon fluorides. A bit less than 10 percent are industrial-grade sodium fluoride, the only fluoride compound that has received extensive toxicological testing. Several potential problems with the silicon fluorides exist, including (1) reassociation of silicon and fluoride in the acidic environment of the stomach to form silicofluorides with unknown biological properties; (2) leaching of lead from brass fittings; and (3) increased uptake of lead into children’s blood. Moreover, the addition of industrial-grade fluorides to the public water supply inevitably leads to exceeding the EPA’s MCLG for arsenic, a known human carcinogen, which is set at zero.
* p<0. 001 means less than one chance in a thousand that this finding is a random result.
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Who Is in Charge?
One of the most puzzling aspects of the American fluoridation program is just who is in charge of it. Neither the American Dental Association (ADA) nor any of the many endorsing agencies listed by the ADA accept any liability for the practice. Historically, the agency that preceded today’s Office of Public Health and Science (OPHS), the U. S. Public Health Service (PHS), endorsed fluoridation in 1950. Various other government agencies followed suit, but of today’s U. S. Department of Health and Human Services (DHHS) (the ultimate parent body for all the federal health agencies in the US), no agencies, divisions or institutes that help to promote or defend this practice appear to accept any legal liability should individuals be harmed.
The DHHS agency most identified with the program today is the Centers for Disease Control and Prevention (CDC). We will discuss its role as well as that of the Food and Drug Administration (FDA) and the Environmental Protection Agency (EPA). These are the three obvious candidates for ownership of this program at the US federal level.
The Centers for Disease Control and Prevention
We begin with the CDC because there is no question that this federal agency is an avid and aggressive promoter of fluoridation, although its involvement stops short of the following:
• Overseeing the safety of the program
• Vouching for the safety of the chemicals used
• Accepting any other liability in the matter
In fact, only one division at the CDC is involved with fluoridation, and that is the Oral Health Division (OHD). This division is largely staffed by personnel with dental rather than medical qualifications. In a 2008 listing of twenty-nine employees in that division, ten had an advanced dental degree, two had a PhD (one of those was in economics), eleven had an MPH (Masters of Public Health) or other master’s degree, one was a professional engineer, and five others were listed without academic or professional qualification. 1
While academic degrees may not tell the whole story about a person’s specialized knowledge, on the face of it there seems to be little evidence to suggest that the OHD personnel have the appropriate educational background to properly evaluate toxicological studies or conduct health-risk assessments.
Even though the CDC has experts in other divisions with the appropriate credentials to review health studies and conduct risk assessments, they have not been given any formal oversight or advisory role on the safety issues pertaining to fluoridation. It is true that a division of the CDC called the Agency for Toxic Substances and Disease Registry (ATSDR) updates toxicological profiles of substances found at hazardous waste sites, including fluoride; however, the profiles are prepared by outside contractors, and the 2003 update had little to say about the risks posed by fluoridation. 2
The only apparent role that the CDC is prepared to play in the matter of fluoridation is that of the OHD’s aggressive promotion of fluoridation throughout the United States. Its stated goal has been for fluoridation to reach 75 percent of the population by 2010. The OHD supports mandatory fluoridation on a statewide basis. With such a commitment to the promotion of fluoridation, it is difficult to see how the OHD could pass an objective judgment on health concerns, even if its personnel had the capacity to do so properly.
The result is that the OHD’s promotion of fluoridation is not tempered by any firsthand knowledge of the safety of the program. For example, neither OHD personnel nor anyone else at the CDC investigates reports that some people may be sensitive to fluoride, even though many people claim to be in this position (see chapter 13). Nor do CDC personnel ensure that fluoride levels in the urine, blood, or bones are monitored in fluoridating communities to gauge the effects of short- and long-term exposures. There is also no evidence that the CDC is involved in any research program to investigate the toxicology of the fluoridating chemicals used.
We cannot look to the CDC to take any responsibility for the safety of water fluoridation. We return to a discussion of the role of the CDC in promoting fluoridation in chapter 23.
The Environmental Protection Agency
The EPA in the United States has no direct role in the water fluoridation program per se, but it does have an indirect role that might ultimately prove decisive. This is because, while the EPA Office of Drinking Water (ODW) does not regulate “additives” to water, it does regulate “contaminants. ” The EPA is required by the Safe Drinking Water Act to determine safe standards for all the contaminants that might enter the water supply from either natural or industrial sources. Currently, the safe drinking water standard, otherwise known as the maximum contaminant level (MCL), for fluoride is 4 ppm. Above that level, water utilities are required by federal law to remove the excess fluoride.
In 2002, the ODW asked the National Research Council of the National Academies (NRC) to review that standard and the related goal (maximum contaminant level goal, or MCLG), which is also set at 4 ppm. In 2003, the NRC appointed a twelve-member panel to investigate the issue, and on March 22, 2006, the panel produced the 507-page report Fluoride in Drinking Water: A Scientific Review of EPA’s Standards 3 (see chapter 14).
The NRC panel concluded that the 4 ppm standard was not protective of health and recommended that the EPA perform a risk assessment to determine a new MCLG. After over four years (as of April 2010), the ODW has failed to produce a new risk assessment or a new MCLG or MCL. Were the agency to produce an MCLG of 0 ppm, as some experts recommend, 4 it would force an end to the fluoridation program. This is the EPA’s indirect involvement with the fluoridation program. It has the power to end fluoridation in the United States, but the issue is such a hot political potato that the agency seems unwilling to act.
The ODW takes no responsibility for the safety of the water fluoridation program itself and seems reluctant even to exercise the influence it could have on the practice by scientifically determining a protective MCLG. Thus, another federal agency is failing to protect the American people.
The Food and Drug Administration
Incredibly, even though fluoride is the most prescribed medicine in U. S. history—now given to over 180 million Americans in their drinking water every day—the FDA has never taken any responsibility for the safety of the water fluoridation program or for the safety of the chemicals used. It has not even tested or regulated the use of fluoride in prescriptions or over-the-counter supplements. As a result, fluoride has never been treated to the clinical trials required by the FDA for other drugs. There has never been a double-blind randomized clinical trial (RCT) for fluoridation’s effectiveness. Nor have there been any well-conducted large-cohort studies in which all the possible confounding variables are controlled.
The FDA does, however, recognize that fluoride is a drug; its official designation is “unapproved new drug” (see chapter 1).
The FDA also regulates fluoride’s use in toothpaste. If readers check the back of a tube of fluoridated toothpaste, they will find this FDA-required warning: “Keep out of the reach of children under 6 years of
age. If you swallow more than used for brushing, get medical help or contact a poison control center right away. ” The recommended quantity for brushing is a “pea-size” dab. Such a dab contains about one-quarter of a milligram of fluoride, about the same amount as in one glass of fluoridated water. The FDA puts warnings on the former but remains silent on the latter.
So if none among the FDA, EPA, and CDC accepts responsibility for regulating the practice or fluoridation, or the fluoridating chemicals used, who does? Here the story gets even more bizarre.
The National Sanitation Foundation International
As we have seen, no federal agency regulates either the practice of water fluoridation or the chemicals used. There is plenty of advice but no responsibility. By default, regulation has been left to a private entity in the United States called the National Sanitation Foundation (NSF) International. This self-regulating, private consortium certifies water-fluoridation chemicals.
NSF Standard 60 established a standard for pollutants that is 10 percent of the maximum contaminant level. Unfortunately, NSF ignores this requirement for the chemicals used in water fluoridation. The MCL for fluoride is 4 ppm, but the NSF allows additions of fluoride between 0. 7 and 1. 2 ppm. Moreover, it ignores the fact that fluoridating chemicals contain arsenic, for which the EPA has assigned an MCLG of zero (see chapter 3). Thus the use of industrial-grade fluoridating agents is increasing the cancer risk for those drinking fluoridated tap water. This is in addition to any cancer risks posed by fluoride itself (see chapter 18).
In an affidavit obtained during preparation for a court case in California, the following exchange took place between Kyle Nordrehaug, lawyer for the plaintiffs, and Stan Hazan, the general manager for the NSF’s Drinking Water Additives Certification Program:
