A federal judge has again denied EPA’s effort to end a potentially precedent-setting suit challenging the agency’s denial of a Toxic Substances Control Act (TSCA) citizen petition seeking to ban drinking water fluoridation, though the judge also rejected plaintiffs’ competing summary judgment motion that sought a quick ruling in their favor.

Judge Edward Chen’s Dec 30 order likely means the case, Food and Water Watch et al v. EPA, will proceed to a de novo bench trial slated to begin in April, the first such legal test under Congress’ 2016 revisions to the law.

In his ruling, Chen of the U.S. District Court for the Northern District of California, rejected EPA’s Oct. 9 summary judgment motion, concluding that the plaintiffs met the low legal bars on both standing and merits issues raised at the summary judgment stage to continue.

Citing case law, Chen explains that “at the summary judgment stage, ‘plaintiffs need not establish that they in fact have standing, but only that there is a genuine question of material fact as to the standing elements,’” before adding that purely speculative inferences about injury or causation cannot meet an Article III standing test.

He adds that individual plaintiffs in the suit have “perhaps barely” resulted in his finding of standing.

“[H]ere it cannot be said that there is ‘no plausible inference’ that fluoride caused Plaintiffs’ headaches; their allegations — supported by a doctor’s note, a related scientific study, and a temporal nexus — rise above the purely speculative, albeit perhaps barely, for standing purposes.”

Chen’s decision followed a Nov. 15 hearing where he posed tough questions for opposing attorneys on the standing and merits issues raised in EPA’s summary judgment motion, though he did not raise questions about the plaintiffs’ competing summary judgment motion.

The case is being closely watched, as it appears to be the first in which a federal court would hold a de novo trial over a petition filed under TSCA’s section 21 citizen’s petition provisions, where a judge could make a risk-based decision that TSCA usually reserves for EPA — and potentially order EPA to write a rule.

Chen’s decision marks the latest loss for EPA in the case, which was filed in 2017 after EPA denied the groups’ petition asking EPA to ban drinking water fluoridation with a TSCA rule.

The once-rarely used citizen’s petition process allows the possibility for a de novo trial before a federal judge, an option Chen allowed to move forward in late 2017 when he ruled that TSCA, as reformed by Congress in 2016, allows citizens to petition EPA to regulate single uses of substances, a stance at odds with the agency’s position in this case.

Chen also ruled against the agency’s arguments last year to restrict the suit to the evidence presented in the original petition and its denial, paving the way for the de novo hearing where plaintiffs are expected to offer a host of expert witnesses and scientific studies on the risks posed by the widely used substance.

He has also rejected EPA motions seeking to delay the trial, ordered the agency to provide internal documents and allowed plaintiffs to depose agency staff on the risks posed by fluoridation.

Summary Judgment Motions

In the latest phase of the case, EPA in October filed a summary judgment motion challenging the suit on standing and merits grounds.

EPA argued that plaintiffs have not provided “evidence demonstrating an unreasonable risk of injury from exposure to fluoridation chemicals used to increase water fluoride concentrations up to 0.7” milligrams per liter (mg/L) of water, the Health and Human Services Department’s existing standard for drinking water fluoridation.

And during the November hearing, EPA’s Justice Department attorney argued the plaintiffs failed to comply with reformed TSCA’s scientific requirements, specifically with regard to performing a systematic review and risk analysis.

But Chen said he “was unable to find, and the parties have not provided, any case law equating the phrase ‘weight of the scientific evidence’ with ‘systematic review,’ or otherwise addressing the regulation. Furthermore … the regulation[‘s] … definition is not so clear that the Court can readily discern that Plaintiffs’ expert did not, as a matter of law, conduct the functional equivalent of a systematic review. Accordingly, summary judgment cannot be granted to the EPA on this basis.”

As to the evidentiary arguments EPA made, Chen concludes that “it is impossible to say that no reasonable juror could find that Plaintiffs are entitled to a verdict in their favor. … [T]he Agency must point to Plaintiffs’ failure ‘to make a showing sufficient to establish the existence of an element essential to [the plaintiff’s] case.’”

Chen also suggests that some of the studies showing harm from fluoridation exposure are potentially compelling, writing that none of EPA’s objections to plaintiffs’ evidence “are sufficient to find for Defendant as a matter of law.” He points to a trio of birth cohort epidemiology studies — known as Bashash 2017, Bashash 2018, and Green 2019 — as well as a recent study of pregnant women in California, which Chen writes “raise genuine issues of material fact that make summary judgment for the EPA inappropriate even under the rigorous scientific modes embraced by [TSCA sections] 6(b) and 26.”

Chen also dismissed plaintiffs’ competing motion for summary judgement, explaining that because Federal Rule of Civil Procedure 56(a) provides that “summary judgment is only appropriate where ‘the movant shows that there is no genuine dispute as to any material fact and the movant is entitled to judgment as a matter of law,’ … Plaintiffs here are not entitled to summary judgment. Although factual certainty is not required, Plaintiffs have failed to demonstrate that no reasonable jury could find that EPA is entitled to a verdict in its favor, particularly where — at this stage — the evidence must be viewed in the light most favorable to the nonmoving party and all justifiable inferences are to be drawn in the nonmovant’s favor.”

*Original article online at https://insideepa.com/share/222564