/>iIn a groundbreaking decision, a federal district court has ordered the U.S. Environmental Protection Agency (EPA) to regulate the “unreasonable risk” it found to be posed by the fluoridation of drinking water. The order came in the long-running case Food & Water Watch, Inc. v. EPA, No. 17-cv-02162-EMC, 2024 WL 4291497 (N.D. Cal. Sept. 24, 2024).
While the court did not specify what EPA must now do, its decision could significantly impact municipal drinking water systems and public health. Supported by the Centers for Disease Control and Prevention, EPA has permitted public water systems to fluoridate their drinking water as a critical measure to control tooth decay for decades. More than three-quarters of the U.S. population today gets their drinking water from fluoridated public sources.
The court order also has substantial implications for the regulated chemical industry and EPA’s regulatory processes under the Toxic Substances Control Act (TSCA). This is the first instance of a court ordering EPA to “initiate a proceeding” under TSCA Section 6(a) in response to a citizen petition denied by EPA and subsequently appealed under Section 21 to a federal court. Both industry and the federal government have previously argued that Section 21 does not authorize a court to order rulemaking but rather a fact-gathering risk evaluation process akin to that normally required under TSCA for chemicals that EPA itself has identified as potentially presenting unreasonable risks under their conditions of use, in part because Section 21 requires a lower standard of evidence than is required of the usual risk evaluation process. A federal court has now implicitly disagreed with that argument, ordering that EPA “initiate rulemaking” to manage the risks it found to be posed by water fluoridation.
Background
EPA permits public drinking water systems to fluoridate drinking water up to certain levels under the Safe Drinking Water Act. EPA has established an enforceable maximum contaminant level (MCL) for fluoride in drinking water at 4.0 milligrams per liter (mg/L), effectively ensuring that community water systems limit fluoridation to levels that EPA has determined present no known or anticipated adverse effects on human health.
EPA has also set a “secondary” standard for fluoride at 2.0 mg/L or 2.0 ppm. Secondary standards are non-enforceable federal guidelines that address potential cosmetic effects (such as skin or tooth discoloration) or aesthetic effects (such as taste, odor, or color) in drinking water, which state or local governments may implement.
The U.S. Department of Health and Human Services (HHS) recommends the fluoridation of drinking water at 0.7 mg/L to achieve the benefits of preventing tooth decay.
Nevertheless, in 2016, a group of NGOs petitioned EPA under TSCA Section 21 to ban the fluoridation of drinking water entirely, arguing that fluoride has neurotoxic effects when ingested even at the “optimal” concentration identified by HHS and so presents an “unreasonable risk to human health.” EPA denied that petition in 2017, and, pursuant to Section 21, the NGOs appealed that denial to the federal district court for the Northern District of California. The district court judge in the case is Edward Chen, who previously had directed EPA to adopt a TSCA Section 8(a) reporting rule for asbestos in another case that contested EPA’s denial of a Section 21 petition. Asbestos Disease Awareness Org. v. EPA, 508 F. Supp. 3d 707 (N.D. Cal. 2020).
In 2019, Judge Chen denied EPA’s motion for summary judgment that had argued that the NGOs were required to comply with all requirements of both Section 6(b) (e.g., provide information equivalent to a risk evaluation) and Section 26 (e.g., provide information reflecting the weight of the scientific evidence). The court did so in part by citing that Sections 6(b) and 26 are not directly incorporated into Section 21, although their provisions may be looked to for guidance. Food & Water Watch, Inc. v. EPA, No. 17-cv-02162-EMC, 2019 WL 8261655 (N.D. Cal. Dec. 30, 2019). Extensive discovery and a trial followed.
TSCA Proceedings
Under TSCA Section 21, any person may petition EPA to “initiate a proceeding” for the issuance, amendment, or repeal of a rule under Section 6(a). 15 U.S.C. § 2620(a). If EPA grants the petition, EPA must start an appropriate rulemaking process to consider the petitioner’s requests. However, if EPA denies the petition—as it did here—it must publish a notice detailing the reasons for the denial. If EPA denies or does not respond to a petition within 90 days, then the petitioner may initiate a civil action in federal district court to compel EPA to “initiate a proceeding” for the requested rulemaking, if the court determines, without consideration of costs, that the subject chemical presents an unreasonable risk to human health or the environment under the conditions of use. The resulting rule under Section 6(a) could impose a variety of controls—ranging from a label warning to an outright ban—to manage the chemical’s identified risks.
Since Congress substantially overhauled TSCA in 2016, it has not been clear what it would mean to “initiate a proceeding” for a Section 6(a) rule. The statute now generally requires prioritization and risk evaluation as critical predicates to rulemaking, and EPA’s risk evaluations must be made according to the “weight of the scientific evidence” and “consistent with the best available science.” 15 U.S.C. § 2625(h)-(i). However, under Section 21, a court only needs to decide whether the chemical substance presents an unreasonable risk “by a preponderance of the evidence,” arguably a lesser scientific standard. 15 U.S.C. § 2620(b)(4)(B). Section 21 also only enables EPA and a specific petitioner or petitioners to present evidence, whereas the full risk evaluation process that would usually inform Section 6 rulemaking involves more than three years’ worth of public participation and comment. Until now, no court had addressed whether a court ordering EPA to “initiate a proceeding” under Section 21 would require EPA to begin the full risk evaluation process or jump directly to rulemaking to manage those risks.
Without substantial analysis, Judge Edward Chen has now provided an answer. He found that the evidence suggests that HHS’s “optimal” level of drinking water fluoridation—0.7 milligrams per liter, well below EPA’s maximum and target concentrations—“poses an unreasonable risk of reduced IQ in children.” The Court then ordered EPA to “initiate rulemaking pursuant to Subsection 6(a) of TSCA.” Order at 2, 79 (emphasis added). Nevertheless, in a footnote, the Court left the door open for EPA to conduct additional analysis or seek additional information to “put a finer point on [the] risk posed by the condition of use before taking regulatory action.” Id. at 67 n.33. Thus, it remains unclear to what extent EPA must now begin to draft regulations on the addition of fluoride to drinking water or may instead engage in the deliberative risk evaluation process.
Impacts and Next Steps
This order could significantly impact the chemical industry and municipal drinking water systems. If courts uphold that a TSCA Section 21 citizen’s petition can be leveraged to force EPA to skip the statutory chemical prioritization and risk evaluation processes and jump directly to rulemaking, then EPA’s chemical regulatory program could foreseeably be overwhelmed by competing priorities. Chemical manufacturers, processors, and users could also potentially face overbroad restrictions due to EPA’s having to regulate certain chemicals on the basis of less (and potentially less comprehensive) information.
Drinking water utilities may also want to closely track this issue, which could significantly impact their operations.
Although the district court ordered EPA to initiate rulemaking to address the level of fluoride in drinking water, it remains to be seen what steps EPA will take next. The possibilities include, among others, that EPA will request more information from the public as part of the initiation of rulemaking; that it will appeal the case to the Ninth Circuit (including the district court’s earlier ruling about the scope of Section 21); and that it will attempt to move the entire matter to the Office of Water under TSCA Section 9(b) on the basis that the risk identified by the court “could be eliminated or reduced to a sufficient extent by actions taken under the authorities” of the Office of Water. Stay tuned.
