Fluoride Action Network

The Safe Drinking Water Act, EPA and Integrity

Fluoride Action Network | December 2, 2015

Welcome to day 2 of FAN’s annual fundraiser. Yesterday we received 18 donations for a total of $1,226 (including two recurring donations for which I computed the total annual donation). This is doubled by our generous matching pledger to yield a grand total of $2,452 from 19 people. This matching pledge will continue up to $5,000.

To make a tax-deductible donation you can either:

  • Or by check – please make checks payable to Fluoride Action Network and send to: FAN, c/o Connett, 104 Walnut Street, Binghamton NY 13905

We try to make these fundraising bulletins either fun or informative or both.  Today it is informative and the information therein should be powerful ammunition in the hands of those who believe that honest science should determine public health policy.

We asked William Hirzy, PhD, formerly a senior scientist at the EPA who specialized in risk assessment, and now FAN’s representative in Washington, DC, to tell us what he knows about the Safe Drinking Water Act (SDWA) and what that Act would require the EPA Office of Water to do if they were genuinely interested in determining a safe drinking water standard for fluoride.

Paul Connett, PhD
Senior Adviser to FAN, and
Director of the 2015 Fundraising campaign

The Safe Drinking Water Act, EPA and Integrity

By J.William Hirzy, PhD

SDWA: Congressional Intent

In our Constitutional form of government laws are made by the Legislative Branch, implemented and enforced by the Executive Branch, with disputes adjudicated by the Judicial Branch. The legislative history of the Safe Drinking Water Act (SDWA, the Act) provides an explanation of just what the Congress intends for the SDWA to do for public health. That history provides guidance for the Executive and Judicial Branches in implementation of and making judgments about the Act.

Theoretically, the Executive Branch, in the person of the Environmental Protection Agency (EPA), and the courts are bound to follow the guidance given by Congress via the legislative history of the Act. To the extent that these Branches follow that guidance, they are acting with integrity and in conformance with our Constitution; to the extent that they do not, they violate both the Constitution and the concept of integrity.

As far back as the initial development of the SDWA, Congress mandated that drinking water standards aimed at protecting public health were to be set in a two-step process. First, a health based goal now known as the Maximum Contaminant Level Goal (MCLG) was to be set, “…solely on considerations of public health and not influenced by political, budgetary or other considerations.” (1). The MCLG is a non-enforceable goal, “…sufficient to prevent the occurrence of any known or anticipated adverse health effect with an adequate margin of safety.” (2)

A key consideration, especially given EPA’s pending revision of SDWA standards, is how Congress intended “anticipated effect” and “adequate margin of safety” to be interpreted. The following paragraph is clear guidance for that interpretation.

 “The incorporation of an adequate margin of safety is not to be confused with the anticipation of adverse health effects. Recommended maximum contaminant levels (now, MCLGs) are to be established by a three-step process. First, the known adverse health effects of contaminants are to be compiled. Second, the Administrator must decide whether any adverse effects can be reasonably anticipated, even though not proved to exist. It is at this point that the Administrator must consider the possible impact of synergistic effects, long-term and multi-media exposures, and the existence of more susceptible groups in the population. Finally, the recommended maximum contaminant level must be set to prevent the occurrence of any known or anticipated adverse effect. It must include an adequate margin of safety, unless there is no safe threshold for a contaminant. In such a case, the recommended maximum contaminant level should be set at the zero level.” (3) (Emphasis Added)

Adverse Health Effect: Developmental Neurotoxicity

There are a growing number of peer-reviewed primary studies on the effect of fluoride exposures on children’s intellectual capabilities, with new research findings being published every few months. These human studies are consistent with other human, animal, fetal and cellular studies indicating fluoride’s neurotoxicity. FAN has compiled a list of some 314 such peer-reviewed studies (4).

Until recently the vast majority of these studies were not available to mainstream Western researchers who have relied on the PubMed search engine. Many of the articles either appeared in Chinese or in the specialist journal Fluoride (which has been excluded from Pub Med, probably for political reasons).  However, after FAN had many of the human studies translated into English they became more accessible. A major breakthrough for Western scientists came in 2012 when Choi et al (2012) published a meta-analysis of 27 studies (including those translated by FAN) that investigated a possible association between fluoride exposure and lowered IQ in children. (5) The results were remarkably consistent with 26 out of 27 showing an IQ lowering of approximately 7 IQ points. The mean concentration of the fluoride concentration in the 20 studies where the source of the fluoride was water (not coal) was 3.52 ppm, which is lower than the current federally enforceable standard of 4 ppm (the MCL).

Based on the Choi et al. (2012) findings the noted public health scientists, Drs. Phillippe Grandjean and Philip Landrigan, have added fluoride to the existing list of substances that cause developmental neurotoxicity. (6)

There can be no question that developmental neurotoxicity meets Congressional criteria for consideration as a “…known or anticipated adverse effect on health…” of fluoride.

Members of FAN have used data from a number of the studies on fluoride’s effect on children’s IQ in a risk analysis using standard EPA methods to estimate a possible “safe” level of exposure. Our work indicates that there may be no “safe” level of exposure to fluoride regarding developmental neurotoxicity, similar to the case of lead. Such a finding if made by the EPA would force an end to water fluoridation.

Studies from areas of China endemic for fluorosis indicate that fluoride can damage the fetal brain (7). Thus it is not clear whether the critical period of exposure as far as fluoride’s impacting human brain development is concerned occurs in the womb or after birth or both.

If EPA is to perform its duty to set fluoride drinking water levels in conformance with Congressional intent and its own Principles of Scientific Integrity (8), it must do so to protect against causing damage to children’s brains, before and after they are born.

To date despite FAN’s extensive communications with the Office of Water on this subject over several years (both in person and in writing) the personnel there have shown no evidence that they are willing to consider fluoride’s impact on the brain in their determination of a new MCLG for fluoride.

After the National Research Council reviewed fluoride’s toxicology in 2006, the panel concluded that the current MCLG and MCL (both set at 4 ppm) were not protective of health and recommended that the EPA Office of Water determine a new MCLG. Nine years later the Office of Water has still not completed this risk analysis but ominously in 2011 appeared at press conference with the Department of Health and Human Services in Jan 2011 “hinting” that they would produce an MCLG which would not threaten the fluoridation program. Their “draft” analysis indicated that they were using severe dental fluorosis as the most sensitive harmful health effect of fluoride, avoiding all mention of fluoride’s neurotoxicity.

Meanwhile, for the ordinary citizen it is bizarre that while U.S. regulatory agencies have take extensive and expensive measures to limit exposure of children to lead because it is neurotoxic, that they should standby in silence while the U.S. Department of Health and Human Services (in the form of the Oral Health Division of the CDC) aggressively promote the deliberate and reckless addition of fluoride – a known neurotoxic substance – to the public drinking water.


1. Leg. Hist. of the Safe Water Drinking Act, 1982 p. 552

2. ibid p. 551

3. ibid p 552

4. Fluoride Action Network. http://fluoridealert.org/studytracker/?effect=brain-2, accessed Dec 1, 2015.

5. Choi et al. 2012. Developmental fluoride neurotoxicity: a systematic review and meta-analysis. Environmental Health Perspectives, 120(10):1362-8.

6.  Grandjean and Landrigan. 2014. Neurobehavioural effects of developmental toxicity. The Lancet Neurology, 13:330–38.

7-10.  See pre-natal studies, http://fluoridealert.org/studies/brain05/

11. Principles of Scientific Integrity, online at http://www2.epa.gov/sites/production/files/2014-11/documents/epa-principles-of-scientific-integrity.pdf.

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