Dow AgroSciences is petitioning EPA to launch a formal registration cancellation hearing for a fluoride pesticide for which the agency is proposing to revoke food safety limits, an early indicator of industry efforts to force EPA to conduct cancellations which face a higher bar than other regulatory approaches since they require officials to justify their decisions with a cost-benefit analysis.

The company filed a Feb. 18 letter asking EPA to conduct a registration hearing and take other procedural steps required by the Federal Insecticide, Fungicide & Rodenticide Act (FIFRA) after the agency recently proposed to revoke tolerances under the Federal Food, Drug & Cosmetic Act (FFDCA) for the company’s fluoride-based pesticides, which goes by the trade name ProFume. The fumigant is used to control a wide range of post-harvest pests in grain mills and other food-handling facilities, according to the company.

“In the absence of approved tolerances, a food containing a sulfuryl fluoride residue would be adulterated under the . . . FFDCA Section 402 and could not be legally moved in interstate commerce,” Dow says in the letter. “Moreover, the termination of tolerances that support the food-related uses of ProFume for the reasons stated in the Proposed Order would require EPA to take action to cancel the underlying FIFRA registered uses and make it a violation of federal law to sell or distribute ProFume for any of those food related uses,” Dow says.

The company says in a footnote that because EPA is proposing to revoke the chemicals’ tolerances, “no hearing rights are currently available under FFDCA to a party adversely affected by [EPA’s] Proposed Order.

One industry source says EPA is likely to grant Dow’s request for a registration cancellation hearing because a recent court ruling ordering the agency to launch a registration cancellation process for a chemical EPA was threatening to ban by enforcement action — Reckitt Benckiser v. EPA — is likely to factor into the agency’s “mental calculus.”

But industry groups are also facing uncertainty as the Supreme Court is currently weighing their request aimed at overturning another court ruling — National Corn Growers Association v. EPA — that backed EPA’s discretion to avoid a hearing on EPA’s revocation of a tolerance for the widely used chemical carbofuran.

EPA has for years sought to ban or limit pesticides by canceling food tolerances under authority contained in the FFDCA or taking enforcement actions — both approaches that did not require the agency to cancel chemicals’ registrations under FIFRA, a process that imposes a higher bar on the agency than FFDCA tolerance revocations since the agency is required to first conduct a time-consuming cost-benefit analysis, among other steps.

EPA has rarely granted hearings on its decisions for registering pesticides and rodenticides, or for decisions setting food safety tolerances for residues of these chemicals on produce, sources say. This is in part because companies rarely challenge EPA’s efforts to limit or ban their products’ use. Instead, pesticide makers usually worked behind closed doors with the agency to resolve any issues and have no need or desire to file for hearings, sources add.

But when the industry resisted agency efforts to cancel the registration of carbofuran, the agency instead moved to revoke the chemical’s tolerances. But when industry challenged the revocation, in Corn Growers, a federal appellate court generally backed EPA’s actions. Industry groups recently petitioned the Supreme Court to review the case.

More recently, in Reckitt, a federal court in Washington, DC, ruled that EPA would have to go through the more-arduous cancellation process for a line of rodenticide products as required by FIFRA.

Dow Seeking Hearing

In the case of Dow’s ProFume, EPA agreed to a long-standing petition from environmentalists to revoke tolerances for ProFume under its FFDCA authority on the heels of releasing new, stricter risk estimates for fluoride and exposure information indicating aggregate exposures to the drinking water treatment mineral might be unsafe.

But Dow is charging that pulling the tolerances for all food uses would result in an effective ban of all of its registered uses and is seeking a registration cancellation hearing and other steps that industry favors. For example, the registration cancellation hearings are overseen by a neutral scientific panel that can assess EPA’s scientific decisions. And the agency is required to assess the benefits of pesticides under FIFRA.

Sources say that in Dow’s case, Reckitt could serve as a game-changer because the court decision means EPA will have to remove all food contact uses to complete its tolerance revocation decision, and the tolerances cannot legally remain on the label once the agency revokes its approval, one industry source says. “EPA very likely cannot make Dow remove these uses from the label without granting them a hearing. At least there is now legal precedent for this,” the industry source says.

An environmentalist source says because of the controversy surrounding the fluoride pesticide case and fluoride in general– a mineral that for decades has been added to drinking water systems for dental hygiene purposes — both EPA and Dow are likely better served to address the matter through an administrative hearing so evidence on both sides can be heard by an objective party.

But the hearing is also not a slam dunk, even factoring in the Reckitt decision, because Dow’s request also bears similar procedural structure to the high-profile carbofuran case, where EPA denied a cancellation hearing for registrant FMC Corporation on the grounds that the company did not meet evidence standards, both sources indicate.

“I would say that the odds for Dow are slightly better than for FMC,” in terms of meeting the evidence standard, the industry source says. But the environmentalist source calls the two cases “pretty procedurally comparable,” and adds that if Dow does get denied a hearing, they are likely to pursue a lawsuit, as industry is doing in the Corn Growers case. Dow laid out some of the points it intends to raise before a judge if granted the hearing, saying in the Feb. 18 letter that it is objecting to EPA setting a new reference dose for fluoride before making a determination on whether it will revise the maximum contaminant level for the mineral, which could change its estimations of aggregate exposure for the fluoride pesticide. Dow also says in the letter that EPA failed to “properly consider the benefits of continued ProFume use to health, safety and the environment,” an argument likely foreshadowing intentions to raise sulfuryl fluoride’s use as a substitute on certain foods, including cocoa, for the ozone depleting methyl bromide.

After EPA issued the proposed order to revoke the tolerances for sulfuryl fluoride, industry and GOP lawmakers raised concerns that the decision would set a dangerous precedent for using the safety provisions under FFDCA, because it stems from objections from a group of environmentalists that the tolerances should not have been established because aggregate exposure to the mineral is unsafe. EPA’s proposal to revoke the tolerances marks the first time the agency has proposed such an action on the grounds that people are already overexposed to the chemical under the FFDCA, and industry sources feared that it could set precedent for further efforts from environmentalists.

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