In a surprise to some industry observers, EPA appears to be downplaying prospects that it will appeal a recent precedential ruling that rejected its efforts to limit litigation over its denial of a citizen petition under the Toxic Substances Control Act (TSCA) to the administrative record, saying the agency will fight the litigation “on the merits.”

“While EPA disagrees with the [court’s] decision to deny the motion to limit the court’s review to the administrative record, the court’s decision simply means that EPA will continue to vigorously defend its decision to deny the petition on the merits as the litigation moves forward,” according to the agency.

At issue is a Feb. 7 ruling that opened the door to plaintiffs that challenge EPA petition denials, offering a broad range of evidence to bolster their case rather than relying on information in EPA’s record.

In this case, Judge Edward Chen of the U.S. District Court for the Northern District of California ruled in Food & Water Watch Inc., et al, v. EPA, that the citizen petition provisions of TSCA allow petitioners whose request for a section 6 rule is not addressed by EPA to seek wholesale de novo consideration of the facts of their case before a federal district court. The opinion overrules EPA’s arguments that such reviews are limited to the information contained in the administrative record.

“The EPA moves for a protective order limiting the scope of review in this litigation to the administrative record, a request that would effectively foreclose Plaintiffs from introducing any evidence in this litigation that was not attached to their administrative petition,” Chen writes.

“The text of the TSCA, its structure, its purpose, and the legislative history make clear that Congress did not intend to impose such a limitation in judicial review of Section 21 citizen petitions.”

Chen ordered the parties to “meet and confer and agree” on a discovery plan consistent with the order.

“I couldn’t ask for a better opinion. It’s a slam dunk,” Michael Connett, the plaintiffs’ pro bono attorney tells Inside EPA. He adds that the citizen petition provisions included in TSCA section 21 were part of the original 1976 statute, yet “this is the first court proceeding to address the de novo [judicial] proceeding.”

The question of whether petitioners who appeal EPA’s action on their section 21 petition seeking a TSCA section 6(a) rulemaking can seek a completely new “trial” of their case before a judge was “never raised in a published court document in 41 years. It’s striking,” Connett says. “If you look at the legislative history, Congress wanted a robust mechanism for citizen oversight over EPA. This court’s decision highlights for environmental groups that Congress created a powerful tool.”

The possibility of de novo review of fluoride risks appealed to petitioners in this case, who have long sought to end drinking water fluoridation but believe their case has received short shrift from EPA and other agencies. They argue the practice — recommended by the U.S. Public Health Service in the 1940s to improve dental health — can result in people ingesting too much fluoride. They point to recent studies showing neurotoxic health risks from fluoride exposure at lower levels than previously considered of concern.

“One of the reasons I was interested in the TSCA petition was to obtain a different forum” for consideration of fluoride and its risks, Connett told Inside EPA in 2016.

“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.”

Litigation ‘Risk’

But that is precisely what some don’t want to see. One industry attorney tells Inside EPA that “EPA has no choice but to appeal” Chen’s ruling on de novo review. “If the appeal is denied, I would think the best course of action is for EPA to settle the case by agreeing to issue a proposed rule,” the source adds.

“The alternative is taking the risk that Judge Chen in a trial de novo will make factual finding about the risk of water fluoridation that will tie EPA’s hands in a subsequent rulemaking.”

Chen’s decision is worrisome for industry officials given their expectation that environmentalists will increase the number of TSCA section 21 petitions they file after his December ruling rejected EPA efforts to dismiss the suit. They say they now expect petitions will become a new way to force EPA to address their concerns as they seek rules to ban or limit uses of chemical that pose unreasonable risk to human health or the environment.

“It’ll be interesting to see if there is an increase in TSCA section 21 petitions,” Connett says.

But he welcomes the court’s decision to allow de novo reviews. “Imagine, you can now get internal documents from EPA. It’s surprising it’s never been tried before.”

But Herb Estreicher, an attorney and chemist with the law firm Keller and Heckman, cautions that the ruling poses significant risks for EPA and industry groups when the agency seeks to reject petitions.

“Obviously the stakes for EPA are high. If the Court hears new evidence and concludes that it is more likely than not that water fluoridation presents an unreasonable risk, EPA will be hard pressed to avoid issuing a Section 6(a) rule to limit or ban the activity,” he says.

Like Connett, Estreicher also believes Chen’s ruling is precedential, and a first-time opinion on the specific issue of de novo review of appealed section 21 petitions.

Pointing to a 1990 U.S. Court of Appeals for the District of Columbia Circuit decision that Chen cites in his ruling, Environmental Defense Fund v. Reilly, Estreicher notes “that case contained language that seems to address this question indirectly [but] I believe Judge Chen’s ruling is the first time a court has squarely ruled on the matter.”

In his methodical ruling, Chen considers statutory language and structure, case law and legislative history. Of the Reilly case, he writes that the “D.C. Circuit reasoned in Reilly not only that the standard of review (i.e., the degree of deference owed to the agency’s position) differed under the TSCA and [the Administrative Procedures Act (APA)], but also that the scope of review was distinct, as the court reiterated several times the APA’s presumptive limitation to the administrative record as a factor distinguishing TSCA from APA review. The clear implication of Reilly is that Section 21 petitions are not limited to the administrative record.”

An environmental attorney close to the case calls Chen’s ruling “another big win for petitioners in section 21 cases. It allows them to introduce new evidence and present live testimony by experts and other witnesses, and also to conduct discovery against the agency, to support the case they present to the court that a chemical presents an unreasonable risk or otherwise merits action under section 21. This will make it easier to prevail than if the court were limited to reviewing the administrative record for the petition, as EPA argued.”

This source adds that Chen “wrote a thorough and careful opinion, amply supported by the case law and the wording of section 21, that will be hard to reverse on appeal. It’s possible that EPA could take an interlocutory appeal to the court of appeals but most likely Judge Chen’s decisions won’t be appealable until after the trial and a decision on the merits, which may be a long time in coming.

‘Persuasive Job’

Estreicher says he has yet to reach a conclusion on the ruling. “Although Judge Chen does a persuasive job parsing through the Statutory language, legislative history, and the use of the phrase ‘de novo proceeding’ in other statutory contexts without more study it is difficult to tell whether EPA has any basis or not for its position,” he says.

Estreicher also thinks EPA has an opportunity “to appeal this ruling to the Ninth Circuit in what is termed an interlocutory appeal or by seeking a writ of mandamus,” but he cautions that both means of appeal “are considered extraordinary forms of relief and the appellate courts are usually not inclined to jump in until the district court has issued a final decision on the merits.”

EPA’s statement, however, appears to indicate the agency doesn’t plan to appeal. “I guess they are basically saying they will defend on the merits their decision to deny the petition before the Court,” Estreicher says of EPA’s statement. “It also doesn’t look like EPA plans to file an interlocutory appeal.”

Connett, meanwhile, is focused on the next steps in the suit. He says that Chen’s ruling does not have any pre-set limits on discovery — the information that plaintiffs can try to seek from EPA.

“Now we have to work with EPA on discovery,” he says, before alluding to a recent epidemiology study of fluoride’s effects that was funded by the National Institutes of Health (NIH) and published last fall, long after his clients petitioned EPA to ban drinking water fluoridation.

“I told the judge about the NIH study from September,” Connett says of the last hearing in the case, held late last month. “He clearly thought it should be considered. If further studies [are published before trial] we’ll be introducing those. I clearly see this case being expert heavy.”

*Online at https://insideepa.com/share/209468