EPA is poised to respond to environmentalists’ suit challenging the agency’s rejection of their petition seeking to ban the practice of fluoridating water under the Toxic Substances Control Act (TSCA), but the case could test EPA’s stance on which chemical uses it must consider in its risk analyses as it has taken a different position on the issue in recently issued TSCA rules.
The suit, Food & Water Watch Inc., et al, v. EPA filed in the U.S. District Court for the Northern District of California, challenges EPA’s decision last February to deny the group’s 2016 petition seeking a ban on fluoridation — a single use of a class of chemicals.
In its rejection notice, the agency said the petition – filed by Food and Water Watch (FWW), the Fluoride Action Network (FAN), and others – was at odds with TSCA’s mandate to review chemicals and address risks from all their uses.
The interpretation was consistent with the Obama EPA’s draft rules setting up the framework for how to regulate existing chemicals under the reformed TSCA. The groups argue in their suit that EPA’s denial is based on flawed scientific assessment of fluoride’s neurotoxic risks and an inaccurate reading of the chemical uses issue in the toxics law update enacted last June.
But the Trump EPA altered the agency’s interpretation of which uses to consider in TSCA analyses when it finalized the framework rules in June. The final rules – governing risk evaluation procedures and chemical prioritization practices – suggest instead that EPA has more discretion in the uses that it chooses to consider in prioritizing chemicals for assessment, evaluating their risks and, if necessary, regulating them.
For example, EPA’s decision to narrow the uses it considers in its evaluations means that the agency does not plan to address legacy uses of some substances, such as asbestos, in evaluations and any future regulatory requirements.
But the question of how much discretion EPA has to identify the uses it considers is likely to be one of the major issues in pending appellate litigation challenging the framework rules. Environmentalists and their supporters are already charging the agency took too narrow a view of what qualifies as a chemical use subject to review.
They say that EPA is required to follow the statutory language, which requires the agency to review “all reasonably foreseen uses” of a chemical.
Industry groups and their supporters say the agency has significant deference to determine what uses to consider.
But even before briefing begins in the two appellate cases – currently pending before the 4th and 9th Circuits – the issue is likely to get attention in the federal district court in San Francisco, where EPA is slated to respond to the groups complaint on Sept. 25.
Judge Edward Chen has ordered EPA to respond to the groups’ complaint by Sept. 25. The order, which Chen signed Sept. 5, suggests that EPA will move to dismiss the suit. It gives the plaintiffs a month to respond to a motion to dismiss.
The suit has spent months toiling through an alternate dispute resolution (ADR) process, but now appears poised to enter briefing for litigation.
“I think all sides agreed ADR won’t be fruitful,” says Michael Connett, an attorney representing the plaintiffs.
Connett says that if EPA bases its dismissal argument on the Obama administration’s argument that the agency is required to consider all uses, the subsequent change in position on uses could be raised at argument. “If EPA moves to dismiss on that ground, I’ll definitely pay attention to that,” Connett says.
Observers tracking EPA’s implementation of the new TSCA law said last spring shortly before the suit was filed that it would provide a test case for the agency’s interpretation that petitioners must provide a comprehensive analysis of all uses of a chemical in order to seek a restriction on a particular use.
“This asserted view, that only a comprehensive risk evaluation considering all conditions of use will suffice, presents a very high threshold for action — and seemingly an impossibly high threshold to move EPA to act,” stated a blog post from the law firm Bergeson & Campbell March 7.
The novel rationale for rejecting the request drew the attention of the firm, which suggested in the blog that the interpretation essentially obviates the purpose of section 21 petitions for agency action under section 6, which has traditionally been to draw the agency’s attention to a chemical hazard that had not previously been a focus.
EPA’s denial outlined general obligations petitioners should meet in seeking chemical restrictions under the updated version of the toxics law. “This requirement includes addressing the full set of conditions of use for a chemical substance and thereby describing an adequate rule under TSCA section 6(a) — one that would reduce the risks of the chemical substance ‘so that the chemical substance or mixture no longer presents’ unreasonable risks under all conditions of use,” the agency said.
“Rather than comprehensively addressing the conditions of use that apply to a particular chemical substance, the petition requests EPA to take action on a single condition of use (water fluoridation) that cuts across a category of chemical substances (fluoridation chemicals),” the agency added.
Bergeson and Campbell attorneys said that EPA’s denial is “essentially arguing that since EPA must assess ‘all conditions of use’ in any control rule they might promulgate, then any outside petition must include all of the same homework before it can be granted.”
Connett also says a recently released study showing IQ losses in children exposed to fluoride in utero could bolster the groups’ case because it could be used to challenge EPA science in court as TSCA section 21 allows federal judges to review agency decisions de novo.
The study, by Morteza Bashash of the University of Toronto’s public health school and colleagues, compared fluoride levels in more than 200 pregnant women with IQ scores in their children four or more years after birth. It found that “higher prenatal exposure to fluoride . . . was associated with lower [General Cognitive Index (GCI)] scores in children at approximately 4 years old, and with lower Full-Scale IQ scores at 6–12 years old.”
The study estimates that “GCI and IQ scores were about 3 and 2.5 points lower in association with a 0.5 [milligram per liter (mg/L)] increase in prenatal exposure, respectively.”
“The associations with GCI appeared to be linear across the range of prenatal exposures, but there was some evidence that associations with IQ may have been limited to exposures above 0.8 mg/L,” it adds.
Connett describes the study, published in the journal Environmental Health Perspectives earlier this month, as “a big boost to our case against EPA. It strengthens our case considerably, especially given the low doses [that pregnant women and children were exposed to] in the study. EPA has always criticized the human studies we rely on. I think this study addresses those concerns.”
Connett noted that the study was funded by a grant from the National Institute of Environmental Health Sciences, and conducted by a team with expertise in neurological effects, rather than expertise in fluoride toxicology.
Connett expects to be able to present this study and others, which he argues should lead to the end of fluoridation, a common practice by American water utilities and localities for some 40 years as a preventative for tooth cavities and decay.
TSCA section 21 is unusual in that it allows petitioners to challenge EPA’s response in federal district court de novo, meaning that the petitioners’ original case is presented before a judge, “who will independently review the evidence without deference to the agency,” he said last March.
“De novo review is very rare in administrative law,” Connett said in the interview last spring, adding that most legal challenges to final agency decisions are governed by the Administrative Procedure Act, where judges review agency responses using the standard of whether they are unlawfully arbitrary and capricious.
“One of the reasons I was interested in the TSCA petition was to obtain a different forum” for fluoride and its risks, Connett said. “It will be good to get the issue considered by people not entrenched in the issue,” he added. “EPA never really applied its own risk assessment procedures to fluoride. We believe if EPA does, then it will see . . . that fluoridation would be incompatible with the dose that would be appropriate.”
The section 21 petition allows Connett the opportunity to prove to a judge that “we’re right, not that EPA screwed up,” he says now.
The groups’ petition argues that fluoride in drinking water often exceeds doses linked to IQ loss and other neurotoxic effects, and that TSCA allows for a “more targeted” ban than under federal drinking water law. EPA, in its most recent six-year review of drinking water contaminants as required by the Safe Drinking Water Act, did not consider fluoride a candidate for review of its drinking water standard.