A federal judge is grappling with tough questions on standing and review standards as he weighs whether to dismiss on both procedural and substantive grounds a potentially precedent-setting suit challenging EPA’s denial of a Toxic Substances Control Act’s (TSCA) citizen petition which asked the agency to ban drinking water fluoridation.
During a Nov. 15 hearing, video of which posted online last week, Judge Edward Chen of the U.S. District Court for the Northern District of California raised tough questions for opposing attorneys about standing and merits issues raised in EPA’s summary judgment motion which had posed a series of new challenges to the landmark suit, though he did not raise questions about the plaintiffs’ competing summary judgment motion.
Chen’s review of EPA’s motion raises questions on whether the landmark case, Food and Water Watch et al v. EPA, will proceed to trial as scheduled in February 2020.
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 TSCA usually reserves for EPA -- and potentially order EPA to write a rule.
The case is slated to go to trial after Chen rejected a series of motions EPA filed seeking to dismiss, limit and delay the suit. For example, he ruled that TSCA allows citizens to petition EPA to regulate single uses of substances, a stance at odds with the agency's position in this case.
And he also ruled against the agency's arguments 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.
But EPA in October filed a summary judgment motion that argues 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 it also questioned whether the plaintiffs have standing to pursue their claims.
In response, the plaintiffs’ attorney argued EPA is claiming that plaintiffs must provide “factual certainty” that fluoridation at the HHS standard causes neurotoxicity to Americans -- which he argued is a level of proof beyond TSCA’s risk-based standard.
Standing To Sue
During the recent oral argument, Chen questioned the plaintiffs’ lawyer, Michael Connett, on whether his clients have standing to sue.
“So when I looked at the description of the various plaintiffs, it’s not obvious, its seems to me, [that they] have standing in the case, given the scope of the case. Plaintiff must have at least a plausible cause of suffering some kind of injury or future injury of neurotoxicity and not some other aspect of fluoridation,” Chen said.
Connett responded that plaintiffs need not meet such a high injury bar to demonstrate standing, citing court precedent. He urged Chen to consider a 2000 decision from the 4th Circuit, Friends of the Earth, Inc. v. Gaston Copper Recycling Corp., which he said the 9th Circuit has relied on considerably.
In that case, the 4th Circuit held that under the Clean Water Act, Congress allows any person who has an interest which may be adversely affected by a violation of the law to bring a citizen suit.
But under TSCA, Connett said Congress “did not limit which persons could bring a claim. It just says any person may petition the administration.”
Connett argued that “As long as plaintiffs have an injury within Article 3, the plaintiffs have standing. Even if the court was to hold that they have some injury, plaintiffs have that.”
Chen questioned Connett over which of the plaintiffs shows injury from drinking water fluoridation.
Connett pointed to some of the individual plaintiffs, one of whom suffered daily headaches for years before finding them resolved weeks after she stopped drinking her fluoridated tap water. Connett noted that headaches are a “classic form of neurological symptom.”
But Chen said there are “millions of causes of headaches,” before questioning Connett further about the plaintiff’s situation, and other individual plaintiffs with “some kind of medical link.”
Justice Department attorney Brandon Adkins argued for EPA that plaintiffs’ interpretation of standing is “not correct.” He argued that because plaintiffs haven’t originally alleged that EPA ought to regulate fluoride to prevent headaches and dementia, those claims “fall outside of the zone of interest here.”
But Chen noted that some of the plaintiffs described headaches and other symptoms they link to fluoride exposure. “You may question the factual nexus, but that seems to be within zone of interest, the ballpark of what they are challenging in the petition,” he said.
Adkins argued that plaintiffs’ original 2016 petition to EPA, asking the agency to ban drinking water fluoridation with a TSCA rule, did not contain allegations that fluoridation caused headaches but instead IQ loss and neurodevelopmental effects. “There is no evidence supporting that exposure to fluoride at the levels that are relevant here” caused harm, Adkins argued. He said plaintiffs have “no standing but for their self-serving declarations. None is a prospective parent.”
“How deeply do you have to get into the merits just to prove standing?” Chen asked. He turned next to some “substantive questions,” asking the arguing attorneys what the “proper mode of analysis under section 21” is and about the implications of finding for plaintiffs on their challenge.
Mode Of Analysis
Chen also asked the attorneys for their views on whether he should conduct a de novo analysis as allowed under section 21 using the criteria in TSCA section 6(b), which sets standards EPA must meet when conducting risk evaluations of existing chemicals that form the basis for risk management rules.
He acknowledged that in one of his earlier rulings in the case, he “disconnected section 6(b) from section 21,” allowing the petition to go forward though the plaintiffs have not addressed any use of fluoride beyond drinking water fluoridation.
Connett replied that Chen could consider section 6(b) criteria but they are not required. Section 6(b) “can be a source of information for the court on what to look for when it considers evidence. But EPA’s position is that it’s required and a prerequisite for plaintiffs’ experts to follow all of the rules set forth for section 6(b) risk evaluations. The court’s analysis in the decision on [EPA’s 2017] motion to dismiss applies equally here. There is nothing in section 21 that incorporates the requirements of section 6(b) here,” he said.
Connett also pointed to legislative history Chen cited in his December 2017 ruling, where “Congress specifically stated the 2016 amendments [to TSCA] were not intended to bring about any substantive change in section 21. But EPA’s position here would bring about a profound change to section 21, because it would ultimately require petitioners to EPA to do systematic review and require courts to require systematic review to review a challenge.”
The problem, Connett argued, is that requiring citizens’ groups to perform or pay for systematic reviews is cost prohibitive. If systematic reviews are required, section 21 petitions will “likely become too onerous for citizen’s groups to pursue,” Connett argued, adding that Congress’ intent was for a “robust mechanism for citizens to ensure that EPA is not letting bureaucratic lethargy get in the way of actively enforcing the laws.”
But Adkins told Chen that “science-based decisions under TSCA must be based on the weight of the scientific evidence. That is a term of art under the statute that Congress defined to mean systematic review. … Plaintiffs would have us make a determination completely divorced from TSCA’s requirements.”
Chen suggested that the court’s de novo review is “kind of a gateway. To say that you have to undertake your own [systematic review], hire scientists, a research team … [isn’t that] a super barrier to any kind of relief?”
Adkins agreed. “But we’re talking about nation-wide policy,” he said, arguing that rules of such breadth and import required the rigor of systematic review. “Because they haven’t done the work, they have not met their burden,” he argued. TSCA requires “consideration of a chemical’s risk under the conditions of use, a very important term of art used in the statute. It’s the reason why all the examples that counsel points to, where EPA has extrapolated hazards from very high exposures, don’t work under the amended TSCA.”
Adkins and Connett explained to Chen the court’s role in conducting a de novo review of a section 21 challenge. Adkins said TSCA section 6(a) would require EPA to “regulate the risk the court determined” in any section 21 challenge. “The court in a sense steps into the shoes of EPA in section 6b when it’s acting under section 21. EPA will have to consider the risks that [are] identified.”
Chen asked Adkins what would be left for EPA to do after such a ruling, and whether, in managing the risk the court determined, “could the administrator reach a different conclusion, that there’s not unreasonable risk or that’s a given at that point?”
Adkins replied that the unreasonable risk determination would “be a given” but EPA would have “discretion in how to manage it.” -- Maria Hegstad (email@example.com)