U.S. Supreme Court Reiterates Deference Given EPA Pesticide Decisions
The U.S. Supreme Court has closed the door on a challenge to EPA’s decision to ban residues of carbofuran, a once commonly used pesticide, in domestically produced food. Declining to review the D.C. Circuit’s decision in National Corn Growers Association v. EPA, the Court let stand regulatory interpretations that make it difficult, if not impossible, to challenge EPA’s pesticide decisions. For now, process, not substance, continues to be the major impediment to such challenges.
Background: Pesticide Regulation Under FIFRA and the FFDCA
Pesticides are principally regulated under two federal laws. The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) regulates the distribution, sale, and use of all pesticides in the United States. Prior to any use, a pesticide must be “registered” by EPA for that use. In addition, the Federal Food, Drug and Cosmetic Act (FFDCA) requires EPA to set limits (called “tolerances”) on the amount of pesticide residue that may remain in or on agricultural food products marketed in the United States.
EPA’s decisions regarding pesticide registration and tolerances are currently governed by standards that incorporate environmental and human health assessments. EPA will register a pesticide only if it determines that the pesticide’s proposed use will “not generally cause unreasonable adverse effects on the environment” – defined as “any unreasonable risk to man or the environment, taking into account the economic, social, and environmental costs and benefits of the use of [the] pesticide.” For pesticides used on food crops, EPA must determine that the tolerance will be “safe,” meaning “that there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue” from dietary and other sources.
Although pesticides have been registered with the federal government since 1947, the registration standard just described – incorporating environmental and human health elements – was not in force until the early 1970s, and has been strengthened since then. Consequently, since 1972 EPA has been required to review all previously-registered pesticides to ensure conformance to current standards. This process (“reregistration” in FIFRA parlance) proceeded at a glacial pace until 1988, when Congress set out a five-stage, ten-year plan for the approximately 1,000 active chemicals yet to be reviewed. Similarly, although tolerances have been set since 1954, the process was significantly revised in 1996, and Congress consequently required EPA to incorporate a reassessment of all existing food tolerances into its reregistration decisions. In 2008, 36 years after its first instruction to do so and ten years after its original ten-year deadline, EPA completed its reregistration decisions for all pesticides. EPA’s efforts are now focused on implementing its decisions.
Background to National Corn Growers: EPA Actions Against Carbofuran
Cases like National Corn Growers arise from one possible outcome to the reregistration process: where EPA determines that a previously-registered pesticide does not meet current standards, either because its use will cause “unreasonable adverse effects to the environment” or the established tolerances are not “safe” as defined by the FFDCA. In that event, EPA takes action to remove the pesticide from the market, using somewhat arcane procedures set out in FIFRA and the FFDCA.
The National Corn Growers case involved the pesticide carbofuran. Marketed as Furadan and first registered in 1969, carbofuran is a cholinesterase inhibitor – a neurotoxin – that can be fatal to humans and wildlife after acute exposure, and has harmful effects even at lower doses, although its chronic low-level exposure effects are disputed. Opponents of its use focus on impacts to wildlife and farm workers during crop application, and to sensitive populations of the general public through ingestion, both in food and drinking water. However, the chemical is also a highly effective and low-cost broad-spectrum crop pesticide that, until EPA’s actions described below, was widely used on many common crops, including corn and potatoes, and for which, in many applications, few equally effective alternatives exist.
In 2006, after completing an acute dietary risk assessment and concluding (over objections) that dietary exposure to carbofuran posed health risks, EPA moved to eliminate carbofuran as a pesticide. Its first action towards this end was under FIFRA’s reregistration process. Despite receiving many comments from growers supporting continued availability, EPA determined that, even for major crops, adequate alternatives existed such that “minimal impacts would … be expected if carbofuran were no longer available for use on those crops.” Consequently, given its conclusion on dietary risk, EPA determined that registrations for most uses were not eligible for reregistration, and that all other uses would be phased out after four years. However – given the intricacies of FIFRA’s cancellation procedures (see below) – this did not result in the immediate cancellation of registrations. Two years later, EPA moved under its FFDCA authority to set all tolerances to “zero,” i.e., to ban carbofuran residue in food, effectively eliminating its use on food crops. This triggered a process that lead, ultimately, to the D.C. Circuit’s decision in National Corn Growers.
National Corn Growers: Request for Hearing Denied
The National Corn Growers decision involved the procedural intricacies attendant to revoking a pesticide tolerance. In brief, the FFDCA requires that this be done in a specialized rulemaking process that includes an opportunity to request a hearing on disputed factual issues. In the first stage, EPA publishes a proposed rule revoking the tolerance and explaining its reasons for doing so, and affected parties submit comments on the proposed revocation rule. After considering the public comments, EPA then publishes a final regulation. Once the final regulation is published, however, affected parties are allowed to file objections on the final rule and request a public evidentiary hearing on any disputed factual issues, and EPA must issue an order ruling on the hearing request. EPA is instructed to conduct a hearing in “summary judgment-like” situations where material facts are in dispute.
In the case of carbofuran, EPA determined that the carbofuran tolerances were “not safe” under the applicable standards, issued a proposed rule revoking all tolerances for food produced in the U.S., considered comments, and issued a final regulation to the same effect. Industry associations representing corn, sunflower, and potato growers, as well as the sole manufacturer of carbofuran, requested a hearing on the scientific underpinnings of EPA’s conclusion, and EPA denied the request.
Although the petitioners were seeking to engage in the merits of EPA’s decision – to argue that EPA’s science was wrong, challenging EPA’s conclusions regarding current concentrations of carbofuran in surface and ground water, and carbofuran toxicity – the hearing request was denied on process grounds. EPA denied the request because (1) the petitioners had not raised certain arguments in their comments on the proposed rule, and (2) the petitioners had already raised their remaining arguments in their comments on the proposed rule, and EPA had rejected those arguments in its final rule. EPA’s hearing denial was appealed to the courts, where the petitioners argued that EPA had created a “Catch 22” situation, where EPA would never have to hold a hearing, even though the rules specifically contemplate one.
On July 23, 2010, the D.C. Circuit in National Corn Growers affirmed EPA’s decision not to hold a hearing. While the decision briefly discussed the merits of the challengers’ scientific arguments, importantly, the Court’s decision was based largely on its determination that the agency’s disagreements with the petitioners’ comments and hearing request objections were due substantial deference. The decision left challengers in a difficult position. Parties must present their entire case in their comments to a proposed rule, but – although the statute allows for a hearing whenever a “summary-judgment-like” dispute of material fact is before the agency – the D.C. Circuit had ruled that EPA is not required to hold a hearing over a “mere” dispute between experts whenever the agency’s conclusions are due deference, which, given EPA’s unique regulatory expertise in regulating pesticides, is almost always the case.
The petitioners presented the case to the Supreme Court largely on the grounds that it was contrary to the Supreme Court’s decision in Weinberger v. Hynson, Wescott & Dunning, Inc., where the Court had affirmed the role of “summary judgment-type” proceedings under the FFDCA, and made much of the fact that EPA has never once held a hearing in response to objections to tolerance decisions. EPA responded that it had only ever ruled on such requests a few times, and in any event that the case was too factually dependent to serve as a vehicle for the issues raised. Ultimately, the Supreme Court declined to hear the case.
Process, Not Substance, Impedes Challenges to EPA Pesticide Decisions
National Corn Growers is one of several recent decisions by federal courts that have highlighted the procedural difficulties confronting those – whether industry, labor, or environmental groups – who would challenge EPA’s pesticide decisions. In United Farm Workers of America, AFL-CIO v. EPA, labor groups hoped to challenge EPA’s decision to allow azinphos-methyl (AZM) to remain in limited use. While seeking review of the merits of EPA’s decision, the groups ran afoul of FIFRA’s bifurcated judicial review provision, which grants different courts jurisdiction depending on whether there has been a public hearing on the challenged issue. A split Ninth Circuit panel ruled that the opportunity to submit comments was a hearing, and dismissed a challenge brought before the district court. Since FIFRA requires suits brought directly in the circuit courts to be filed within 60 days, the petitioners had missed their opportunity and, like in National Corn Growers, the case was lost without a serious examination of the merits.
Things worked out differently in Reckitt Benckiser Inc. v. EPA, although not at first. There, EPA had circumvented FIFRA’s pesticide registration cancellation proceedings by threatening to bring an enforcement action for misbranding against products that it had determined would not be reregistered, without first moving to cancel the registrations. While the district court dismissed the challenge on jurisdictional grounds (similar to United Farm Workers), the D.C. Circuit reversed. On remand, the district court finally reached the merits and held that EPA had violated FIFRA, which “entitles the registrant to notice, a hearing and other procedural protections before EPA can make a final decision on cancellation,” and enjoined enforcement action until those procedures were followed.
The common thread in these decisions is that EPA has taken every opportunity to avoid conducting hearings on its technical conclusions, even though FIFRA and the FFDCA contemplate that this be done. In two (and almost three) of the three most recent cases, the challenges to these actions have been lost not on the merits, but in EPA’s procedural thicket. As the Supreme Court has declined to review National Corn Growers, the situation is unlikely to change.
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