‘Precedent setting’ case puts judge in role of making chemical risk determinations, attorneys say

A federal trial underway in California could set a new standard for how courts handle citizen petitions under TSCA and provide advocacy groups a judicial pathway to seek regulatory action on chemicals of concern.

This trial is the first time there is a de novo proceeding to review the evidence to determine whether the EPA must regulate a chemical substance under TSCA section 6(a), Herbert Estreicher, a partner with Keller and Heckman, told Chemical Watch.

The case puts the judge, rather than the EPA, in a position to weigh the evidence and decide whether a chemical presents an unreasonable risk. “That’s remarkable,” Dr Estreicher said.

At issue in the trial before the US District Court for the Northern District of California is the agency’s 2017 decision to deny a petition, filed by a group of medical academies and environmental organisations, to force the EPA to use section 6 of TSCA to prohibit the addition of fluoride to drinking water (see box).

TSCA citizen petitions in the past have had little success in effecting change. Since September 2007, there have only been eight petitions asking the agency to impose regulatory controls, according to the EPA’s public listing. None have been granted.

But if the plaintiffs win the case and the EPA ordered to issue a section 6 rule for fluoride, it could prompt more advocacy groups to take advantage of TSCA section 21, the citizen petition provision. It allows anyone to potentially bypass the TSCA prioritisation process by petitioning the agency to take action on a specific substance and, if the agency refuses, have that decision considered by a court.

More petitions for ‘celebrity chemicals’

If the group win, “you’ll see EPA granting a lot more petitions,” Dr Estreicher said. That could mean the petition process is really controlling the EPA’s agenda.

That does not mean the litigation floodgates will open, however, in cases where the agency denies a section 21 petition. Going through a trial like this “must be a hugely expensive exercise”, Dr Estreicher said.

Lynn Bergeson, managing partner at Bergson and Campbell, agreed that a victory would make citizen petitions a “more visible option” for advocacy groups.

It will be a potential pathway for litigants that have the means and the resources to prevail, said Ms Bergeson. That may be more likely for ‘celebrity chemicals’, like per- and polyfluoroalkyl substances (PFASs), where advocates are impassioned and motivated.

“Win, lose or draw,” section 21 petitions will be “on the checklist” of options for plaintiffs to pursue, she said.


In their opening argument on 8 June, attorneys for the EPA acknowledged the uniqueness of the legal proceedings, noting that the court is now “sitting in the place of the EPA administrator”.

A risk evaluation must be supported by a risk assessment conducted with a systematic review of the evidence, attorney John Do said. “It’s a science in and of itself.”

Before the court is the EPA’s predefined methodology versus the plaintiff’s preconceived notions, Mr Do said.

“If I were counsel for the government,” Ms Bergeson told Chemical Watch, “I would certainly be stressing to Judge Chen the precedent-setting nature” of his ruling in this case, which could upset the provisions of TSCA in a way Congress never intended.

A spokesperson for the EPA said it “is confident that there is still no scientifically defensible basis to justify the regulation of fluoridation chemicals added to drinking water”, as it spelled out when it originally denied the petition.

In his own opening statement, however, Michael Connett, the attorney representing the petitioners, said: “We can go above and beyond the evidential burden of proof” to show that fluoridation chemicals present an unreasonable risk of harm.

Dr Estreicher said it is now down to a “battle of the experts”. Judge Chen will be making a decision that traditionally belongs to the agency that has expertise in the area, he said. “But that’s the way Congress set it up,” when it amended TSCA section 21 as part of the law’s 2016 overhaul.

If the EPA loses the trial, Ms Bergeson said she expects the agency would either appeal the ruling or initiate an “appropriately targeted and calibrated section 6 rule to address the risk”.

The trial is scheduled to run until 19 June.

Road to Trial

In late 2016, Food & Water Watch, the Fluoride Action Network, the American Academy of Environmental Medicine and others petitioned the EPA to put in place a rule under section 6(a) of TSCA to prohibit the purposeful addition of fluoride chemicals to drinking water. The EPA has only finalised one such rule in the past 30 years.

There is no federal requirement to add fluoride to drinking water. But the EPA does set a maximum contaminant level for the substance.

The EPA denied the petition in 2017, and the groups filed suit. The agency sought to dismiss the case, arguing that the latter had failed to adequately address fluoride’s full set of conditions of use, as required under a TSCA risk evaluation.

Judge Edward M Chen disagreed, however, allowing the case to proceed. In a later ruling, Judge Chen again sided with the NGOs, granting their request to offer a broad range of evidence to bolster their case.

That set the stage for the current trial.

*Original article online for free membership at https://chemicalwatch.com/125182