Food & Water Watch, Inc. v. Environmental Protection Agency

Background

Section 6 of the Toxic Substances Control Act requires the Environmental Protection Agency (EPA) to evaluate and regulate chemical substances that pose an unreasonable risk to health or the environment. Section 21 allows a person to petition the EPA to begin that regulation process.

The plaintiffs petitioned the EPA to regulate the addition of fluoridation chemicals to drinking water, arguing that fluoride ingestion poses an unreasonable risk of neurotoxic harm. The EPA denied the original petition, and the plaintiffs filed this lawsuit. The parties later stipulated that the plaintiffs would rely exclusively on specified declarations to establish standing—the requirement that a plaintiff show a legally sufficient personal injury allowing the plaintiff to sue.

After a bench trial in June 2020, the court placed the case on hold and directed the plaintiffs to submit a new petition addressing later scientific developments. The court was concerned that the trial evidence focused on possible neurodevelopmental harm to fetuses and infants, while the named plaintiffs had not alleged that they were pregnant, planning to become pregnant, or caring for infants. The court stated that it would allow the plaintiffs to amend the complaint if the EPA denied the new petition.

The plaintiffs submitted a supplemental petition, including new scientific material and allegations that members lived in areas with fluoridated water and were pregnant or seeking to become pregnant. The EPA denied that petition, stating that the submitted evidence was insufficient for an informed risk determination and that it would not reopen the administrative record at that time. The EPA also said that new information was continuing to develop.

Motion to Supplement

The plaintiffs moved under Federal Rule of Civil Procedure 15(d), which permits a court to allow additional allegations based on events occurring after the original pleading. Their proposed supplemental complaint added standing allegations concerning Jessica Trader, a Food & Water Watch member who lived in a city that added fluoridation chemicals to its water. The allegations stated that she had suffered dental fluorosis, became pregnant, and incurred ongoing costs for bottled water and replacement water-filter cartridges to limit her unborn child’s exposure to fluoridated water.

The proposed complaint also added scientific allegations concerning studies of early-life fluoride exposure and neurodevelopment, including material related to the National Toxicology Program’s draft monograph and pooled analyses of two studies identified in the opinion as the ELEMENT and MIREC studies.

The EPA did not dispute, for purposes of its opposition, that the plaintiffs could cure the alleged standing problem through supplemental pleadings. It argued instead that supplementation would be futile because of the earlier standing stipulation and would prejudice the EPA by requiring additional discovery and evidence concerning evolving scientific research.

Court’s Analysis

The court held that the standing stipulation should be set aside. It found that preventing supplementation could result in dismissal of the case and therefore create a manifest injustice. Trader’s pregnancy occurred after the stipulation and was material to the standing issue. The court also found that setting aside the stipulation would not prejudice the EPA because the agency did not show that it would have presented different trial evidence had it known of the pregnancy. The stipulation remained in effect for the other eight witnesses.

The court separately considered the scientific allegations. It recognized that the National Academy of Sciences, Engineering, and Medicine had reviewed the draft National Toxicology Program monograph and that the scientific record continued to develop. The court concluded that the EPA should have an opportunity to address the final monograph and potentially additional cohort studies after peer review. The court stated that it intended to keep the case on hold at least until the final monograph was released and possibly until additional studies were peer-reviewed.

The court concluded that supplementation would promote judicial economy. Because the case had not reached final disposition, allowing the supplemental allegations would permit the dispute to continue in one action rather than requiring a new petition, a new lawsuit, and potentially duplicated discovery and trial proceedings.

Disposition

Judge Edward M. Chen granted the plaintiffs’ motion for leave to supplement the complaint. The court ordered that the case’s abeyance otherwise remain in place until further order. It stated that, if the EPA wished to challenge the plaintiffs’ standing, the EPA could file a motion to dismiss within 30 days of the order. The order disposed of Docket No. 279. It did not decide the ultimate scientific question whether fluoride poses an unreasonable risk or whether the EPA must regulate fluoridation.