Consensus Report

Fluoride in Drinking Water: A Scientific Review of EPA's Standards (2006)


Each report is produced by a committee of experts selected by the Academy to address a particular statement of task and is subject to a rigorous, independent peer review; while the reports represent views of the committee, they also are endorsed by the Academy. Learn more on our expert consensus reports.

Most people associate fluoride with the practice of intentionally adding fluoride to public drinking-water supplies for the prevention of tooth decay. However, fluoride can also enter public water systems from natural sources, including runoff from weathering of fluoride-containing rocks and soils and leaching from soil into groundwater. Fluoride pollution from various industrial emissions can also contaminate water supplies. In a few areas of the United States, fluoride concentrations in water are much higher than normal, mostly from natural sources. Because it can occur at toxic levels, fluoride is one of the drinking water contaminants regulated by the U.S. Environmental Protection Agency (EPA). In 1986, EPA established a maximum allowable concentration for fluoride in drinking water of 4 milligrams per liter (mg/L), a guideline designed to prevent the public from being exposed to harmful levels of fluoride. After reviewing research on various health effects from exposure to fluoride, including studies conducted in the last 10 years, this report concludes that EPA\u0092s drinking water standard for fluoride does not protect against adverse health effects. Just over 200,000 Americans live in communities where fluoride levels in drinking water are 4 mg/L or higher. Children in those communities are at risk of developing severe tooth enamel fluorosis, a condition that can cause tooth enamel loss and pitting. A majority of the report\u0092s authoring committee also concluded that people who drink water containing 4 mg/L or more of fluoride over a lifetime are likely at increased risk for bone fractures.

Key Messages

  • A few studies of human populations have suggested that fluoride might be associated with alterations in reproductive hormones, fertility, and Down's syndrome, but their design limitations make them of little value for risk evaluation
  • Assessing whether fluoride constitutes a risk factor for osteosarcoma is complicated by the rarity of the disease and the difficulty of characterizing biologic dose because of the ubiquity of population exposure to fluoride and the difficulty of acquiring bone samples in nonaffected individuals.
  • Bone fluoride concentrations increase with both magnitude and length of exposure. Empirical data suggest substantial variations in bone fluoride concentrations at any given water concentration.
  • Case reports and in vitro and animal studies indicated that exposure to fluoride at concentrations greater than 4 mg/L can be irritating to the gastrointestinal system, affect renal tissues and function, and alter hepatic and immunologic parameters. Such effects are unlikely to be a risk for the average individual exposed to fluoride at 4 mg/L in drinking water. However, a potentially susceptible subpopulation comprises individuals with renal impairments who retain more fluoride than healthy people do.
  • Fluoride is an endocrine disruptor in the broad sense of altering normal endocrine function or response, although probably not in the sense of mimicking a normal hormone. The mechanisms of action remain to be worked out and appear to include both direct and indirect mechanisms.
  • Gaps in the information on fluoride prevented the committee from making some judgments about the safety or the risks of fluoride at concentrations of 2 to 4 mg/L.
  • Groups likely to have increased bone fluoride concentrations include the elderly and people with severe renal insufficiency.
  • In light of the collective evidence on various health end points and total exposure to fluoride, the committee concludes that EPA�s MCLG of 4 mg/L should be lowered.
  • Little data is available on immunologic parameters in human subjects exposed to fluoride from drinking water or osteoporosis therapy, but in vitro and animal data suggest the need for more research in this area.
  • On the basis of information largely derived from histological, chemical, and molecular studies, it is apparent that fluorides have the ability to interfere with the functions of the brain and the body by direct and indirect means.
  • On the basis of pharmacokinetic modeling, the current best estimate for bone fluoride concentrations after 70 years of exposure to fluoride at 4 mg/L in water is 10,000 to 12,000 mg/kg in bone ash. Higher values would be predicted for people consuming large amounts of water (>2 L/day) or for those with additional sources of exposure. Less information was available for estimating bone concentrations from lifetime exposure to fluoride in water at 2 mg/L. The committee estimates average bone concentrations of 4,000 to 5,000 mg/kg ash.
  • Pharmacokinetics should be taken into account when comparing effects of fluoride in different species. Limited evidence suggests that rats require higher chronic exposures than humans to achieve the same plasma and bone concentrations.
  • Studies of the effects of fluoride on the kidney, liver, and immune system indicate that exposure to concentrations much higher than 4 mg/L can affect renal tissues and function and cause hepatic and immunologic alterations in test animals and in vitro test systems.
  • The committee did not find any human studies on drinking water containing fluoride at 4 mg/L where GI, renal, hepatic, or immune effects were carefully documented.
  • The committee finds that the available epidemiologic data for assessing bone fracture risk in relation to fluoride exposure around 2 mg/L are inadequate for drawing firm conclusions about the risk or safety of exposures at that concentration.
  • The committee's conclusions regarding the potential for adverse effects from fluoride at 2 to 4 mg/L in drinking water do not address the lower exposures commonly experienced by most U.S. citizens. The charge to the committee did not include an examination of the benefits and risks that might occur at these lower concentrations of fluoride in drinking water.
  • The damage to teeth caused by severe enamel fluorosis is a toxic effect that the majority of the committee judged to be consistent with prevailing risk assessment definitions of adverse health effects.
  • The degree to which moderate enamel fluorosis might go beyond a cosmetic effect to create an adverse psychological effect or an adverse effect on social functioning is also not known.
  • The single most important contributor to fluoride exposures (approaching 50% or more) is fluoridated water and other beverages and foods prepared or manufactured with fluoridated water.