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From Products Liability Law Daily, August 10, 2018

EPA order maintaining tolerance for particular pesticide vacated

By Rebecca Mayo, J.D.

The U.S. Court of Appeals for the Ninth Circuit vacated the Environmental Protection Agency’s (EPA) 2017 order maintaining a tolerance for the pesticide chlorpyrifos. The court held that there was no justification for the EPA’s decision to maintain a tolerance for chlorpyrifos in the face of scientific evidence that its residue on food causes neurodevelopmental damage to children. It further held that the EPA was in direct contravention of the federal Food, Drug, and Cosmetic Act (FDC Act) (21 U.S.C. §301 et seq.) and the Federal Insecticide, Fungicide, and Rodentcide Act (FIFRA) (7 U.S.C. §136 et seq.) (League of United Latin American Citizens v. Wheeler, August 9, 2018, Rakoff, J.).

Chlorpyrifos. Chlorpyrifos is a pesticide that kills insects by suppressing acetelycholinestrerase, an enzyme that acts as a neurotransmitter in various organisms, including humans. It was initially developed as a nerve gas during World War II, but in 1965 it was approved as a pesticide for agricultural, residential, and commercial purposes. In response to the FDC Act’s heightened safety standards, the EPA cancelled all residential uses of chlorpyrifos in 1998, while allowing residue tolerances for 80 food crops. A 2016 risk assessment by the EPA concluded that the risk from potential aggregate exposure to chlorpyrifos did not meet the FDC Act’s safety standard. It further concluded that expected residues of chlorpyrifos on most individual food crops exceeded the "reasonable certainty of no harm" safety standard.

Statute. The FDC Act prescribes that food with any pesticide chemical reside shall be deemed unsafe and barred from movement in interstate commerce. The EPA may establish tolerances for pesticides which would allow foods with residues of those pesticides to move in interstate commerce. However, a tolerance may only be established if it has been determined that there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue. Once a tolerance is established, the EPA bears continuous responsibility to ensure that the tolerance continues to satisfy the FDC Act’s safety standard. The EPA is subject to these same safety standards in exercising its authority to register pesticides under FIFRA.

Procedural background. In 2007 two organizations filed a petition proposing that the EPA revoke tolerances for the pesticide chlorpyrifos. The petition included studies showing that children and infants who had been exposed prenatally to low doses of chlorpyrifos suffered harms such as reduced IQ, attention deficit disorders, and delayed motor development, that lasted into adulthood. After years of inaction, the groups petitioned the court twice for a writ of mandamus to force the EPA to take action. After being ordered to issue a final response, the EPA issued a proposed rule in 2015 revoking all tolerances for chlorpyrifos, but it failed to move forward so the court again ordered the EPA to take final action.

In April 2017, the EPA denied the 2007 petition on the merits and left the chlorpyrifos tolerances in effect, stating that it would not revoke tolerances as the science addressing neurodevelopmental effects remained unsolved. After further motions for mandamus relief were denied, the groups petitioned the circuit court for review and filed objections to the EPA’s administrative review process.

Jurisdiction. The EPA argued that the FDC Act requires a party to file an objection to the order denying their petition and wait for a final order to be issued before obtaining judicial review. The court held that this is a claims-processing rule, not a jurisdictional limitation on the courts, and therefore the courts had the power to waive the requirement of exhaustion of administrative remedies. The EPA’s interpretation of the FDC Act’s administrative review provision as providing limitless time to response to objections would give the agency "virtually unlimited discretion to bury large claims like [this one] in the Administrative process, and to stay judicial proceedings for an unconscionably long period of time." The delay is particularly prejudicial here where the continued use of chlorpyrifos is associated with severe and irreversible health effects. The court concluded that the groups need not exhaust their administrative objections and are not precluded from raising the issues at hand on the merits.

Decision. The 2017 order declining to revoke chlorpyrifos tolerances found significant uncertainty as to the health effects of chlorpyrifos, which is at odds with a finding of "reasonable certainty" of safety under the FDC Act and therefore mandates revoking the tolerances. The EPA cannot refuse to act against its own scientific findings because of the possibility of contradiction in the future by evidence. Therefore, the court vacated the 2017 order maintaining chlorpyrifos and remanded the case to the EPA with directions to revoke all tolerances and cancel all registrations for chlorpyrifos within 60 days.

The case is No. 17-71636.

Attorneys: Kristen Lee Boyles (Earthjustice) for League of United Latin American Citizens, Pesticide Action Network North America., Natural Resources Defense Council and California Rural Legal Assistance Foundation. Brian Joseph Stretch, U.S. Department of Justice, for Andrew Wheeler.

Companies: League of United Latin American Citizens; Pesticide Action Network North America.; Natural Resources Defense Council; California Rural Legal Assistance Foundation

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