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November/December 2024 Issue

Also in this issue: EEOC Files its First Pregnant Workers Fairness Act Lawsuit     |     Wait and See After Dane County Judge Issues Decision on Act 10     |     Federal Court Strikes Down 2024 Salary Level Rules

Fluoridation of Public Drinking Water in Question

For decades many public water utilities throughout the world have added fluoride to their drinking water supplies as a public health matter to help prevent tooth decay. Many public health agencies, including the Wisconsin Department of Health and Human Services,1 continue to advocate for the fluoridation of drinking water.2

However, fluoridation has not been without controversy with vocal advocates, including some prominent ones,3 opposed to adding fluoride to water and various commercial products like toothpaste. Opponents of fluoridation recently notched a victory in a case before the United States District Court for the Northern District of California (District Court): Food & Water Watch, Inc. et al. v. United States Environmental Protection Agency, et al, case no. 17-cv-02162-EMC. 

On September 24, 2024, the District Court issued its findings of fact and conclusions of law stemming from its judicial review of the EPA’s denial of a citizen’s petition under the Toxic Substances Control Act (TSCA) related to the fluoridation of drinking water. The District Court found that, under the strictures of TSCA, fluoridation of water at the optimal level of 0.7 milligrams per liter poses an unreasonable risk of reduced IQ in children. While the court could not order the EPA to take any specific regulatory action under TSCA — including, for example, restricting or limiting the fluoridation of drinking water — the court did order the EPA to take some form of TSCA authorized action.

In Wisconsin, whether or not to fluoridate a community’s drinking water is a local — and a political — decision. Understanding the ruling, the TSCA, public health agency responses, and potential future public health agency responses may be key to charting your community’s future with water fluoridation. This article provides some background to help understand the ruling and current public health agency responses.4

Toxic Substances Control Act

The TSCA provides the EPA with the authority to regulate certain chemical substances. Once the EPA determines that a chemical poses an unreasonable risk to health or the environment, the EPA can promulgate a rule to impose a variety of requirements, including but not limited to labeling and the prohibition, restriction, or limitation of the general use, specific use, and/​or manufacturing of the chemical. 15 U.S.C. § 2605(a). The TSCA prescribes the process that EPA must follow to evaluate risk. The evaluation process involves a risk assessment and a risk determination. The risk assessment includes (1) a hazard assessment which determines at what point of departure” the chemical becomes hazardous; (2) an exposure assessment, which determines the level at which populations are exposed to the chemical; and (3) a risk characterization, which compares the point of departure and the exposure level and includes a margin of safety due to uncertainty in data. The risk characterization involves a summary of findings from the assessment and a determination of whether the chemical presents an unreasonable risk to health or the environment, taking into account the type of harm and number of people exposed.

Congress amended the TSCA in 2016 to allow a citizen to petition the EPA to evaluate and initiate rulemaking related to a specific chemical substance. A petitioner may seek judicial review if the EPA denies such a citizen petition. The court then considers the petition without granting deference to the EPA’s denial. To succeed at judicial review, a petitioner need only prove to the judge that it is more likely than not that a chemical presents a risk of injury to human health and that such a risk is unreasonable.

Citizen Petition and Subsequent Action Related to Fluoride in Drinking Water

In 2016, a group of organizations, which included Food & Water Watch, Inc., petitioned the EPA to regulate the fluoridation of drinking water, asserting that the ingestion of fluoride poses an unreasonable risk of neurotoxic harm to humans including IQ loss.

In 2017, the EPA denied the citizen petition primarily because EPA concluded that the petition has not set forth a scientifically defensible basis to conclude that any persons have suffered neurotoxic harm as a result of exposure to fluoride in the U.S. through the purposeful addition of fluoridation chemicals to drinking water or otherwise from fluoride exposure in the U.S.”

The petitioners then sought judicial review. Beginning in June 2020, the parties built the court record, resulting in an initial bench trial. The court stayed the case, in part to consider the imminent publication of the National Toxicology Program’s Monograph on the Systematic Review of Fluoride Exposure and Neurodevelopmental and Cognitive Health Effects” (NTP Monograph). The court lifted the stay in 2022 and held a second bench trial in January of 2024. On September 24, 2024, the court issued its findings of fact and conclusions of law.

District Court Decision

The District Court’s decision is lengthy and involves an analysis of the record built by the petitioners and the EPA as applied to the TSCA risk evaluation. The court put substantial weight on the NTP Monograph. In reviewing 72 epidemiological studies on fluoride exposure, the NTP Monograph concluded, with moderate confidence, that there is an association between lower IQ scores and populations whose total fluoride exposure approximates or exceeds the WHO Guidelines for Drinking-water Quality of 1.5 mg/​L of fluoride. The NTP Monograph did not conclude cause and effect — only that an association exists. The court also considered additional studies that found an association at lower levels, while rejecting some studies that found no association or the opposite result.

After using the established record to conduct the TSCA risk evaluation process, the District Court found that fluoridation of water at the optimal fluoridated level of 0.7 milligrams per liter poses an unreasonable risk of reduced IQ in children.” The court stated that this finding does not conclude with certainty that fluoridated water is injurious to public health … just that there is an unreasonable risk of such injury,” requiring EPA action under the TSCA (emphasis in original). The District Court directed the EPA to take regulatory action but did not and could not mandate what that action must entail. That decision is left to the discretion of the EPA.

Governmental and National Association Responses

As of now, there have not been any official statements by the EPA or Wisconsin agencies in response to the ruling. The EPA may appeal the decision, but so far has not made any public statements on its intent. The EPA has previously described the NTP Monograph as inadequate to support revision of the current fluoride standard5 but the new Trump administration could take a different stance.6 If the District Court’s decision is not appealed, what action the EPA may take under the TSCA is likely to be made by the new administration.

The American Dental Association and American Academy of Pediatrics continue to recommend fluoridation of drinking water and toothpaste and have questioned the NTP Monograph.7 However, some communities have used the ruling as support for local efforts to stop fluoridation of their drinking water.8

Conclusion

The decision on whether to fluoridate your community’s drinking water currently remains a local one in Wisconsin. For better or worse, that means it is up to each Wisconsin municipality with a public water utility to do its own research and decide on whether to continue, end, or start the practice of water fluoridation.

[1] Oral Health Program: Fluoride and Community Water Fluoridation, https://www.dhs.wisconsin.gov/... (last accessed December 6, 2024)[2] Fluoride is a naturally occurring anion of the element fluorine and is naturally present in groundwater at low levels. In rare cases, high natural occurring levels of fluoride may be removed from water sources. More commonly, fluoride is added to drinking water to increase the natural level to recommended levels of 0.7 milligrams per liter. [3] Included in the opposition is former presidential candidate and current nominee to lead the federal Health and Human Services Department Robert F. Kenney Jr., who has made recent headlines related to his opposition to fluoride.[4] This article is based on a memo provided to the Municipal Environmental Group-Water Division (?MEG-Water?) shortly after the ruling came out. MEG-Water is a coalition of municipal water systems formed in 1991 to help shape the laws and regulations that affect municipal water utilities in Wisconsin. MEG-Water also provides updates and education to its members related to important laws, rules, and issues affecting municipal water utilities. Membership is available to any Wisconsin municipality which owns and operates a water utility. See https://megwater.org/about-meg... for more information. [5] Available at https://www.federalregister.go... [6] In addition, the Center for Disease Control?s and U.S. Public Health Service community water fluoridation recommendations currently remain unchanged, but could also be subject to revision based on the priorities of the new administration. See https://www.cdc.gov/fluoridati... and https://www.ncbi.nlm.nih.gov/p...[7] See https://www.ada.org/about/pres... and https://publications.aap.org/a....[8] See e.g., https://www.naplesnews.com/sto....

This newsletter is published and distributed for informational pur- poses only. It does not offer legal advice with respect to particular situations, and does not purport to be a complete treatment of the legal issues surrounding any topic. Because your situation may differ from those described in this Newsletter, you should not rely solely on this information in making legal decisions.

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