The federal judge overseeing the first-time trial next month on whether EPA must regulate water fluoridation under the Toxic Substances Control Act (TSCA) has codified his earlier verbal rulings barring the agency from presenting evidence on the practice’s benefits while leaving the door open for EPA to argue that it could defer any regulation.
In a recent order that fills in several key procedural details ahead of the trial that is slated to begin June 8, Judge Edward Chen of the U.S. District Court for the Northern District of California detailed in writing his recent verbal order barring EPA from presenting evidence at the trial on fluoride’s benefits.
Chen also detailed his decision allowing the agency to present evidence that any regulation could be delayed, but only if Chen were to rule for plaintiffs that drinking water fluoridation presents an unreasonable risk to health.
“Taking all of this together, the plain text of the statute, the structure of the statute, and its legislative history all indicate that consideration of benefits at the risk evaluation stage is inappropriate,” Chen concluded.
As a result, Chen granted plaintiffs’ motion to exclude testimony regarding the dental health benefits of fluoridating drinking water over EPA’s objections.
Chen added, however that he would “permit EPA to challenge Plaintiffs’ experts on the topic of benefits, to the extent those experts wrote extensively about benefits in their expert reports for the limited purpose of challenging the credibility of these expert reports,” during the trial.
The suit, Food & Water Watch, Inc. et al v. EPA., is a first-time challenge to EPA’s dismissal of a citizen’s petition under TSCA. It is slated to go to a virtual trial beginning June 8, where plaintiffs will seek to prove the practice of water fluoridation leads to neurological harms that pose an “unreasonable risk” and require regulation.
TSCA section 21, which defines the citizen’s petition process, allows petitioners to challenge an EPA dismissal of their petition in a federal district court and in some cases, like Food and Water Watch, receive a trial de novo, rather than judicial review limited to the existing administrative record.
The statute also requires the judge to determine whether a chemical’s condition of use presents an unreasonable risk of injury to health or the environment, the law’s regulatory threshold and one of the key reasons that plaintiffs filed suit.
For example, TSCA section 21(b)(4)(B)(ii) states that if the court concludes that the chemical “presents an unreasonable risk of injury to health or the environment, without consideration of costs or other nonrisk factors” then “the court shall order the [EPA] Administrator to initiate the action requested by the petitioner.”
Plaintiffs in the case have already won several important precedents, including overcoming an EPA motion to dismiss that argued TSCA bars regulation of a single use of a substance. They have also won the right to a de novo trial, allowing them to present evidence to the judge to determine whether the substance poses an “unreasonable risk,” the threshold for regulatory action.
Plaintiff’s attorney Michael Connett, with the firm Waters Kraus & Paul in Los Angeles, told Inside EPA in 2017 that plaintiffs saw benefit in bringing their case before a judge without a public health agency’s views on the controversial claims.
"It will be good to get the issue considered by people not entrenched in the issue," he said. "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."
As the case has moved closer to trial, the parties have filed a series of motions aimed at addressing key procedural questions, which nevertheless have policy significance.
For example, the plaintiffs sought to bar EPA, represented by the Justice Department (DOJ), from presenting evidence in the risk evaluation phase of the trial on fluoride’s benefits.
In his order, Chen agrees with plaintiffs’ argument that the statute’s text, structure and legislative history support their argument that benefits should only be considered when EPA seeks to manage the unreasonable risk a chemical’s use presents, not during risk evaluation.
“TSCA’s broad preclusion of ‘nonrisk factor’ literally encompasses benefits; benefit after all is a nonrisk factor,” Chen writes.
Chen notes that TSCA “does not define ‘costs’ or ‘nonrisk factors,’ and the parties disagree as to whether this applies to the health benefits of fluoridation."
He says the trouble with EPA’s argument that absence of a chemical that provides health benefit is also a health risk “is that in asserting the existence of the inverse risk, it presumes the absence of the fluoridation if an unreasonable risk is found. However, the rulemaking process does not require that a substance which poses an unreasonable risk be banned outright. It merely triggers a rulemaking process, in which the costs and benefits of the substance are considered in determining how to manage that risk.”
Chen concludes that “EPA may choose from a wide range of management tools other than an outright ban . . . That the inverse risk cannot be determined at the ‘unreasonable risk’ juncture (because the ultimate rule will not be determined until the subsequent rulemaking process is completed) undermines EPA’s inverse risk construct.”
Chen also agrees with plaintiffs’ argument that the structure of TSCA indicates benefits should not be considered in the risk evaluation phase, noting that benefits are only described in sections that discuss risk management, not in those that discuss evaluation, such as sections 6(b) or 21. Chen quotes the 1983 Supreme Court ruling in Russello v. U.S., where the justices found, “here Congress includes particular language in one section of a statute but omits it in another section of the same Act, it is generally presumed that Congress acts intentionally and purposely in the disparate inclusion or exclusion.”
And Chen described EPA’s arguments as unconvincing, noting that while EPA’s implementing rule for risk evaluation “included factors that EPA would consider in conducting risk evaluations, but it does not explicitly mention
benefits” and “[w]hile the Court acknowledges that the Rule does put a great deal of emphasis on flexibility . . . that general orientation toward customization does not overcome the fact that the rule enumerated certain factors obviously considered to be important in conducting risk evaluations and, in doing so, did not mention benefits.”
Chen also considered EPA’s argument that EPA’s Framework for Metals Risk Assessment, referenced in TSCA section 6(b)(2)(E), requires the consideration of benefits associated with fluoridation. Chen, however, notes that while “the Framework directs that the essentiality of a metal to health be considered . . . fluoride is neither a metal nor a metal compound. The Framework is therefore irrelevant unless reference to the Framework was intended to convey a broader mode of analysis applicable to non-metals. The Court concludes it does not.”
But Chen also concluded -- in agreement with EPA -- that witnesses at the trial cannot address factors that could allow EPA to defer taking risk management action on fluoridation before Chen rules on whether the practice presents unreasonable risk to human health.
At issue is TSCA section 21(b)(4)(B)(ii), which allows the court to permit EPA to defer acting on a judge’s unreasonable risk finding “[i]f the court finds that the extent of the risk to health or the environment alleged by the petitioner is less than the extent of risks to health or the environment with respect to which the Administrator is taking action under this chapter and there are insufficient resources available to the Administrator to take the action requested by the petitioner . . . until such time as the court prescribes."
As a result, Chen has adopted a bifurcated trial structure to consider separately questions on whether fluoridation poses an unreasonable risk that must be addressed and when the agency must regulate it.
“EPA’s proposal to postpone a determination about whether EPA will be permitted to defer rulemaking makes imminent sense. There is little reason to address this issue prior to a finding by the Court that an unreasonable risk exists. And the relevant inquiries (into the resources available at EPA and into the other substances the Administrator is currently acting upon) may very well continue to change during the time when this Court is adjudicating the issue of unreasonable risk,” Chen writes.
Chen adds that he “does not intend -- should this issue become relevant -- to preclude EPA from introducing evidence that the Agency should be permitted to defer rulemaking.” -- Maria Hegstad (firstname.lastname@example.org)