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INSIGHT: Fluoridation Case Challenges EPA Chemical Evaluation

Aug. 7, 2020, 8:01 AM

A trial in federal court breaks new ground by challenging fluoridation, a 70-year-old public health measure affecting more than 200 million Americans served by public water systems. Further, the case is a unique one as it is the first-ever legal challenge to the EPA’s dismissal of a citizen’s petition under Section 21 of the Toxic Substances Control Act.

In June, a federal judge in the U.S. District Court for the Northern District of California asked the Environmental Protection Agency and environmental advocates to try to reach an agreement before he makes a ruling in the potentially far-reaching case involving the EPA’s denial of a TSCA citizens’ petition asking the EPA to limit the addition of fluoride to drinking water.

Judge Edward M. Chen, the trial judge, asked the parties to return to the negotiating table to discuss a path forward, but suggested he would issue a decision if the parties fail to reach an agreement. He also intimated that it would be prudent for the EPA to find a way to reduce the risk of adding fluoride to drinking water—without being compelled to do so by the court.

Notably, the case puts Chen in the unique position of weighing evidence to decide whether fluoride poses an unreasonable risk to human health such that it must be regulated under the TSCA, a role generally reserved for the EPA. Moreover, the decision is being closely watched, as a plaintiff victory could spur more advocacy groups to take advantage of Section 21.

In fact, the plaintiffs in the case have already won a series of legal victories that could set precedent for similar suits in the future. This includes the court’s denial of the EPA’s motion to dismiss and its restriction on EPA evidence regarding the purported oral health benefits of fluoridation.

Genesis of Case

The case’s genesis traces back to November 22, 2016, when Food & Water Watch, the Fluoride Action Network, and other non-governmental organizations petitioned the EPA to fulfill its responsibilities under Section 6 of the TSCA by banning the addition of fluoridating chemicals to drinking water. The EPA denied the petition, disagreeing with the alleged risks of fluoridated water.

The EPA also stated that a petition under Section 21 of the TSCA must include a complete risk evaluation, including an analysis of all conditions of use—showing how the TSCA risk standard is exceeded—before the EPA would grant the petition.

The organizations filed suit shortly after the EPA’s denial of the petition in 2017.

Passed in 1976, the TSCA endowed the EPA with the authority to regulate chemical substances and mixtures that “may present an unreasonable risk of injury to health or the environment.” TSCA was later amended in June 2016 by the Frank R. Lautenberg Chemical Safety for the 21st Century Act. Among other changes, the act added mandates for the EPA to: (1) evaluate existing chemicals, with clear and enforceable deadlines; (2) assess chemicals against a risk-based safety standard; and (3) eliminate unreasonable risks identified in the risk evaluation.

Importantly, Section 21 of the revamped TSCA provides that any person may petition the EPA to initiate a proceeding for the issuance, amendment, or repeal of a rule under either:

  • Section 4—rules requiring chemical testing;
  • Section 6—rules imposing regulatory controls on chemicals;
  • Section 8—rules requiring information;
  • Section 5(e)—orders affecting new chemical substances; and/or
  • Section 6(b)(2)—orders affecting quality control procedures.

In addition, the TSCA also gives the EPA the authority to prohibit drinking water additives, such as fluoride.

Scientific Testimony

Testifying for the plaintiffs were scientists who had published a series of long-term studies of human exposure to fluoride in well-regarded, peer-reviewed journals. The studies cross-referenced maternal urinary testing to subsequent IQ tests, and connected even the low levels found in fluoridated water to health effects that included attention-deficit hyperactivity disorder, as well as an average loss of several points of IQ in children—roughly equivalent to the impact of low levels of lead.

In court, EPA witnesses conceded that fluoride at high enough levels can harm developing brains, before children develop a protective “blood-brain barrier” at about the age of six months.

Following expert testimony and closing arguments, Chen suggested that he would refrain from making a ruling to allow the EPA time to reevaluate fluoride’s risks (or allow plaintiffs to file a new petition) based on additional information raised at trial, implying that the EPA had used the wrong standard in its evaluation. Chen then set a further status hearing for Aug. 6, 2020, at which time the parties can report any progress toward an out-of-court resolution.

Importantly, this is one of the first cases under the TSCA’s citizen-suit provision to reach trial, and may embolden similar groups’ efforts to compel the EPA to reevaluate chemicals it has long-determined safe—all based on how a federal judge weighs the expert testimony and scientific studies offered at trial.

This column does not necessarily reflect the opinion of The Bureau of National Affairs, Inc. or its owners.

Author Information

Davina Pujari is a partner at Hanson Bridgett LLP and co-chair of the firm’s Environment and Natural Resources Group.

Cole Benbow is an associate at Hanson Bridgett LLP and a member of the firm’s Environment and Natural Resources Group.

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