A first-of-its-kind ruling on the health risks of the tooth-strengthening chemical fluoride could open the floodgates to an influx of other efforts to compel EPA action, creating uncertainty for the agency, experts say.
The decision — precedent-setting for Toxic Substances Control Act citizen petitions — represents a rare occasion in which a judge disagreed with federal officials on the science, forcing EPA to regulate against its wishes.
“We’ve certainly shown that this is a powerful law for citizen groups, so we might see an uptick from here,” said Michael Connett, the attorney representing the petitioniers and a partner at Siri & Glimstad, about the TSCA petition process.
Fluoride in drinking water — at levels public health officials consider “optimal” for preventing tooth decay — “poses an unreasonable risk of reduced IQ in children,” Senior Judge Edward Chen wrote in his Sept. 24 decision out of the U.S. District Court for the Northern District of California.
“It should be noted that this finding does not conclude with certainty that fluoridated water is injurious to public health,” but that a risk sufficient to trigger rulemaking under TSCA exists, Chen continued.
That conclusion grants many of the requests a coalition of anti-fluoride groups asked of the agency in a 2016 petition, which EPA denied on both scientific and procedural grounds.
EPA’s rejection, followed by a court dismissal, is where all TSCA petitions lawsuits ended up until this case. Chen in 2017 was the first judge to agree to hear a case alleging EPA wrongfully dismissed a petition, and he was the first to rule in the petitioner’s favor.
Legal experts, including Connett, project a possible rise in the number of TSCA petitions filed each year.
EPA on average receives about two TSCA petitions each year, based on a fairly consistent 17-year average. An overwhelming majority of those petitions are filed by environmental health advocacy groups.
Lynn Bergeson, managing partner at Bergeson & Campbell specializing in chemical regulations, said she believes more manufacturers and industry groups may start viewing petitions “as an equal opportunity tool.”
“I think the value of the petition process is increasingly going to be optimized by all kinds of entities to reprioritize issues for EPA,” Bergeson continued. “It’s an option that even if it’s unsuccessful, you’ve achieved goals by just filing the petition, getting the headlines, getting EPA to think about it as a priority, and highlighting an action that without the petition process would be infinitely more difficult to cast some light on.”
EPA’s Office of Pollution Prevention and Toxics has struggled to carry out its responsibilities, citing resource gaps, since Congress passed major TSCA amendments in 2016.
“The agency has too much to do, too few people and too few resources to do what it must do,” Bergeson said. “If you have a 100 percent increase in petitions, then EPA has to put resources on this unscheduled event and the aftermath of a decision, whether it’s a yes or a no.
“That element of uncertainty and structural disarray … could be disastrous for the agency over the long run,” she continued.
An influx in TSCA petitions isn’t the only way this ruling could inject chaos.
EPA has determined only a handful of chemicals pose an “unreasonable risk” under TSCA, a designation that follows years of evaluating the risks. Chen’s ruling is the first to bypass EPA’s risk evaluation process under TSCA.
“The judge took the issue away from EPA and decided it himself,” said Bob Sussman, an attorney with Sussman & Associates and former deputy administrator at EPA. “This is very, very unusual. Unknown under TSCA.”
The Biden administration’s approach considers all the ways a chemical is used before determining if an unreasonable risk exists. Chen’s order deviates from that process, because he only considered fluoride in drinking water.
“So how do you harmonize the judge’s order with the reality of the way TSCA is being implemented? I have no good answers for that,” Bergeson said. “I don’t think the court’s elaborate, very thoughtful review of the data is a proxy for an EPA risk evaluation.”
No ‘clear path’ for EPA
Just how far EPA will take the mandatory rulemaking process is the big question.
TSCA gives EPA a menu of “methods to neutralize the risk, ranging from” a public notice to a full-on ban on adding fluoride to tap water, Chen wrote in his decision.
“One thing the EPA cannot do, however, in the face of this Court’s finding, is to ignore that risk,” the decision continues.
“I don’t see a clear path that EPA will want to follow,” said Sussman, who acted as a consultant for the anti-fluoride groups. “It puts EPA and other federal agencies in a really tough spot.”
Connett, who also serves as a consultant for the Fluoride Action Network, one of the plaintiffs in the lawsuit, is still pushing for a ban.
“EPA’s obligation is to eliminate the risk,” Connett said. “So whatever approach they take here, that’s what they need to achieve … and the only effective way that you can eliminate the risk posed by adding fluoride chemicals to drinking water is to stop adding it.”
Sussman said a full ban on fluoride is “a very, very big ask” that is “much bigger than EPA.”
“I don’t see EPA rushing into this with a warm embrace,” he continued. “I think it’s going to take a lot of effort to get EPA to do something really powerful here.”
The fluoride ruling does not set a deadline for when the agency must initiate rulemaking.
And EPA could appeal the decision to the 9th U.S. Circuit Court of Appeals; the government usually has 60 days to file an appeal.
“The government is reviewing the record of these proceedings and determining whether to seek appellate review,” Brandon Adkins, a Justice Department attorney representing EPA, said in a letter filed Tuesday asking the court to defer scheduling a briefing on costs and fees until after the government’s deadline.
“These efforts require an extensive commitment of resources,” Adkins continued, “especially considering that this litigation has now spanned over seven years.”
“EPA has to manage the optics of challenging this decision in the court of the public opinion,” Bergeson said. “So for those reasons alone, I think there might be a reason for EPA and DOJ to go back and find a more politically … and legally palatable pathway forward.”
‘More questions than answers’
Meanwhile, a few communities — including Yorktown, New York; and Abilene, Texas — have stopped fluoridation since the ruling.
“We’re already seeing an uptick, and I expect there’s going to be a lot more communities doing the same thing as people hear that this federal court has found that fluoridation poses an unreasonable risk of injury to the brain,” Connett said.
Some, however, are waiting for EPA’s response to the ruling before making a decision, according to those who work with utilities.
So far, the ruling has not spurred more interest among the public at large about the use of fluoride, said Dan Hartnett, chief advocacy officer at the Association of Metropolitan Water Agencies. The trade association believes the use of fluoride should be decided “at the state or local level,” Harnett said.
“I think there’s probably more questions than answers at this point among our members,” Harnett said.
But Mike McGill, a communications liaison for the water sector and president of WaterPIO, said some utilities are making their stance clear, at least privately.
“Some of my clients are dead firm and saying, ‘We’re going to do it until EPA says we can’t do it anymore,'” McGill said. “Others are waiting to see what EPA does, because if EPA doesn’t appeal and gives credence to the judge’s decision, even with the convoluted way he arrived at it, then it’s harder for a utility to stand firm.”
A long history
Water utilities, at the advice of public health officials, have been adding man-made fluoride chemicals to drinking water supplies since the 1940s to help fight cavities and tooth decay. Approximately 75 percent of the population gets their drinking water from a fluoridated source, according to the Centers for Disease Control and Prevention.
Scientists, however, have for decades known too much fluoride can lead to bone disease and other serious illnesses.
Experts generally agree, and EPA officials testified, that fluoride is neurotoxic, meaning it can cause damage to the brain and nervous system. The question the judge ruled on was whether concentrations currently considered safe for public health pose health threats.
EPA in 1986 under the Safe Drinking Water Act capped fluoride concentrations in drinking water at 4 milligrams per liter, and the agency says levels above 2 milligrams per liter should come with a warning. Meanwhile, the U.S. Public Health Service “recommends an optimal fluoride concentration of 0.7 milligrams/liter,” according to a 2015 rule.
That “optimal” level “poses an unreasonable risk of reduced IQ in children,” Chen wrote.
Linda Birnbaum, the former director of the National Institute of Environmental Health Sciences and National Toxicology program and a federal scientist for over 40 years, called Chen’s decision “excellent.”
“There are growing concerns with fluoridation of drinking water, because, like many things, inorganic fluoride has the potential to affect brain development in children, and there’s something we should be able to do about it,” Birnbaum said.
But Justice Department attorneys representing EPA argued the evidence on neurotoxic effects at lower concentrations was insufficient.
EPA did not immediately align its approach with the judge’s scientific conclusions.
“While the decision finds a risk sufficient to trigger regulation under the Toxic Substances Control Act, it is important to note that the court does not ‘conclude with certainty that fluoridated water is injurious to public health,’ and defers to EPA’s expertise as to how to evaluate and regulate fluoride appropriately moving forward,” EPA spokesperson Jeff Landis said in a statement following the ruling.
A spokesperson for the Office of the Assistant Secretary for Health, which oversees the Public Health Service, declined to comment on how the ruling might impact its current fluoride recommendation.
