Regulatory highlights from the final week of 2022

Chemicals | By WALKER LIVINGSTON, ESQ, PATRICIA ISCARO, ESQ.

Jan. 04, 2023

The following analyses highlight and summarize actions taken over the past week. Of particular interest is the release of the EPA’s definition of “waters of the United States” or WOTUS in concert with the Army Corps of Engineers. The two circuit court decisions and the EPA proposed interim decisions for pesticides all concern the required Endangered Species Act consultations for pesticide.

Waters of the United States

  • The EPA and Army Corps of Engineers have finally released the agencies’ revised definition of “waters of the United States,” the immensely important distinction over what waterways are federally regulated under the Clean Water Act. The appropriate definition of waters of the United States, or WOTUS, has been consistently litigated since the Clean Water Act was passed in 1972, more than 50 years ago. The EPA focused on a new “durable” definition of WOTUS, as it attempts to jump the Supreme Court’s expected June 2023 ruling on the definition of WOTUS in Sackett v. EPA.
  • The new rule, finalized on December 30, 2022 ( pre-publication version available here) provides the agencies jurisdiction over traditionally navigable waters, territorial seas, and interstate waters. In addition to these waters, tributaries and adjacent wetlands are covered via two standards, the “significant nexus” test and the “relatively permanent” test. The “significant nexus” flows from the Supreme Court’s decision in Rapanos v. United States, a 2006 case that applied a test to determine whether the potentially covered water body significantly affected the chemical, physical, or biological integrity of an already-covered body of water. If the potentially covered body did, it had a “significant nexus” to the already-covered body and would therefore be covered by the Clean Water Act. The “relatively permanent” test includes bodies of water that are relatively permanent, standing, or continuous with a connection to already-covered bodies of water.
  • The rule also includes several important exclusions, including wetland converted to cropland before 1985, artificially irrigated areas or lakes or ponds, ditches, and erosional features.
  • The rule represents a major policy point for the agencies and will likely continue to attract the same large degree of attention that the proposed rule did (see the agencies’ responses to comments on the proposed rule here). However, this will likely not be the end of litigation or regulation over the definition of WOTUS. The Supreme Court may determine that the agencies have overstepped their boundaries and rein in the definition in June.

Ninth Circuit Reprimands EPA for Failing to Meet Pesticide Law Requirements Again

  • The EPA has not fared well in recent trips to the Ninth Circuit. The Circuit recently scolded the Agency for failing to follow through with required Endangered Species Act (ESA) consultations for pesticide registration reviews, and the EPA was back at the Circuit for a similar reason in this case. The court confirmed its ire towards the Agency in the first two sentences of the opinion: “It’s déjà vu all over again. The U.S. Environmental Protection Agency (EPA) comes before this court once more because of its failure to abide by the law.”
  • The case concerns sulfoxaflor, an insecticide with a large number of uses in industrial and agricultural settings. Dow Agrosciences LLC requested to register sulfoxaflor in 2010, and the EPA requested public comment for a conditional registration of the insecticide in 2013. However, the EPA unconditionally registered sulfoxaflor several months later, leading to a lawsuit where the Ninth Circuit eventually vacated the sulfoxaflor registration in 2015 based on limited data around the insecticide’s effects on honeybees and ordered additional studies. In 2016, the EPA conditionally registered sulfoxaflor without conducting those studies, and unconditionally registered the insecticide in 2019.
  • The Circuit held that the Agency had violated the required ESA mandate when it unconditionally registered sulfoxaflor. The Circuit stated that even if the EPA was too understaffed to comply with the ESA (as it had argued), it could not “flout the will of Congress just because it contends it is too busy or understaffed.” Notably, the panel did not actually vacate the EPA’s decision on sulfoxaflor, surmising it could cause additional harm to the environment and disrupt the agricultural industry, and instead remanded the decision to the EPA to complete an ESA effects determination and notice and comment obligation within six months of the order.

D.C. Circuit Holds Cases on Fungicides After EPA Completes Earlier Settlement

  • In another ESA-related case, the D.C. Circuit decided to hold four pesticide registrations in limbo pending EPA biological investigations after the Agency successfully completed its ESA mandates for cuprous iodide. Decisions on the four remaining pesticides, halauxfen-methyl, benzovindiflupyr, flyupyradifurone, and bicyclopyrone will be held in abeyance pending the EPA’s successful completion of biological evaluations of the pesticides. The court granted the dismissal of the cuprous iodide case after the parties agreed that the EPA had successfully complied with its terms of the settlement agreement.

EPA proposes interim registration review decisions for several pesticides

  • The EPA announced nine proposed interim pesticide registration review decisions (PIDs) in keeping with requirements of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). The EPA must review registered pesticides every fifteen years to ensure they do not present unreasonable adverse effects on human health or the environment.
  • In December 2021, EPA announced an updated registration review schedule through fiscal year 2025 and has been updating the schedule quarterly. As part of its review, the EPA must complete an Endangered Species Act (ESA) listed-species assessment and any necessary ESA consultation with the U.S. Fish and Wildlife Service and the National Marine Fisheries Service (the Services). For each pesticide ingredient, the entire FIFRA and ESA process typically takes no less than four years, and sometimes over 12 years.
  • The PIDs for the four conventional pesticide cases include Interim Ecological Mitigation measures described in the EPA’s workplan update of November 2022. The workplan outlines efforts to reduce pesticide exposure to nontarget organisms, including listed species, during the FIFRA registration review process and through other FIFRA actions.
  • EPA is proposing to mitigate risks presented by the antimicrobial substance by cancelling higher risk uses. For instance, in the PID for 1,3-PAD, EPA is proposing to terminate uses in metalworking fluids and oil field flood water systems, which have the highest ecological risk.
  • For the four biopesticides, EPA did not propose specific Interim Ecological Mitigation measures because EPA determined that each of these chemicals will have no effect on listed species or their designated critical habitats and no additional mitigations were needed.
  • Comments will be accepted through March 8, 2023 with reference to each docket number listed below.
Registration review case name and No. Docket ID No.
1,3-Propanediamine, N-(3-aminopropyl)-N-dodecyl- (1,3-PAD), Case Number 5109 – used in poultry and animal housing facilities, restaurants, beverage and food processing plants, and schools, where it is used to sanitize non-food contact surfaces such as floors and walls and to control fruit flies in floor and sink drains. It is also registered for use in metalworking fluids and oil field flood water systems. EPA-HQ-OPP-2014-0406
DCNA, Case Number 0113 – fungicide registered for use on crops such as celery, fennel, endive, lettuce, onion, shallot, garlic, snap beans, and Christmas trees EPA-HQ-OPP-2016-0141
Etofenprox, Case Number 7407 – insecticide structurally similar to the pyrethroids, etofenprox is registered for use on rice, in indoor residential and commercial settings, on pets for flea and tick control, and for public health mosquito control. EPA-HQ-OPP-2007-0804
Lavandulyl Senecioate, Case Number 6307 – A synthetic pheromone to attract male vine mealybugs to disrupt their mating cycle and protect raisins, table grapes, and wine grapes. EPA-HQ-OPP-2022-0356
Norflurazon, Case Number 0229 – An herbicide used to suppress germinating grass and broadleaf weeds for agricultural crops such as alfalfa, almonds, apples, asparagus, citrus, grapes and caneberries. It is also used in non-crop areas on agricultural premises. EPA-HQ-OPP-2012-0565
Oregano Oil, Case Number 6342 – A contact herbicide used to control moss on a variety of outdoor structures and surfaces. EPA-HQ-OPP-2022-0641
Penta-termanone, Case Number 6313 – A blend of naturally occurring hydrocarbons found in the waxy outer layer of some termites that acts as a pheromone and is used for termite control. EPA-HQ-OPP-2022-0657
Plant Extract 620 * (* Derived from Quercus falcata, Opuntia lindheimeri, Rhus aromatica, and Rhizophoria mangle tissues), Case Number 6071 – A fungicide used to control parasitic nematodes and certain fungal infections. Also used as a plant growth regulator EPA-HQ-OPP-2013-0587
Thiophanate-methyl and Carbendazim, Case Number 2680 – Systemic fungicide registered for use on various fruits, nuts, and vegetable crops, and as seed treatment for beans, peanuts and potatoes. It is also used in non-agricultural settings such as golf courses, sod farms, greenhouses, and nurseries. Carbendazim is used in antimicrobial products as an industrial biocide for materials preservation and as a conventional tree injection. EPA-HQ-OPP-2014-0004

To contact the authors of this analysis, please email Walker Livingston ( [email protected]) or Patricia Iscaro ( [email protected])

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