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By Lisa M. Campbell and Lisa R. Burchi

On July 12, 2021, the U.S. Environmental Protection Agency (EPA) announced in the Federal Register a notice of availability of a petition filed on April 8, 2021, by the Center for Biological Diversity (CBD) requesting that EPA cancel Elanco US Inc.’s (formerly Bayer Healthcare LLC) Product, PNR1427, more commonly known as Seresto (Petition). 86 Fed. Reg. 36546. The Petition also requests that EPA suspend the registration pending the requested cancellation. Seresto has been registered under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) since 2012 for flea and tick treatment on adult dogs and puppies and on adult cats and kittens.

Comments on the Petition are due on or before September 10, 2021, in docket EPA-HQ-OPP-2021-0409.

Under FIFRA Section 6(b), EPA may cancel a pesticide product’s registration if it appears to EPA that the pesticide, “when used in accordance with widespread and commonly recognized practice, generally causes unreasonable adverse effects on the environment.” In its Petition, CBD states that, “according to a recent aggregate incident summary report, since this product was introduced in 2012, EPA has received over 75,000 adverse incident reports, including at least 1,698 reports linking the use of this product to pet deaths and at least 700 involving human harm.” CBD states this product “contains as active ingredients the neonicotinoid imidacloprid (10%) and the pyrethroid flumethrin (4.5%).” CBD states further, “Understanding each of these ingredients, alone and in combination, is important for understanding the toxicity and risks that their use in Seresto presents to dogs, cats, humans, and exposed threatened and endangered species.” With regard to imidacloprid, CBD states in its Petition, “Neonicotinoids like imidacloprid are most well-known for the harms they cause to pollinator species, including threatened and endangered pollinators like the Poweshiek skipperling (endangered), Dakota skipper (threatened), and rusty patched bumble bee (endangered).” The Petition discusses several studies and EPA risk assessments related to both ingredients, as well as what it describes as the “synergistic effects” of the combination of imidacloprid and flumethrin. CBD argues that Seresto poses an unreasonable risk to human health, pets, and the environment and that EPA should cancel the registration pursuant to FIFRA Section 6(b).

CBD additionally argues that EPA should suspend the registration, asserting that EPA can suspend a pesticide’s registration under FIFRA Section 6(c)(1) when such action is necessary to prevent an “imminent hazard” during the time required for cancellation. The standard to be met to be considered an imminent hazard is high, as “imminent hazard” is defined under FIFRA Section 2(l) as “a situation which exists when the continued use of a pesticide during the time required for [a] cancellation proceeding would be likely to result in unreasonable adverse effects on the environment or will involve unreasonable hazard to the survival of a species declared endangered or threatened.” CBD argues that suspension is warranted in this case because, CDC asserts, both criteria for an imminent hazard are satisfied -- CDC asserts that the products at issue pose both “ongoing and imminent unreasonable adverse effects on the environment and unreasonable hazard to the survival of the endangered rusty patched bumble bee, as well as other imperiled pollinators).”

Commentary

This Petition is one prong in a larger effort by certain groups to halt sales and use of Seresto. EPA’s press release statements indicate that EPA shares some concerns raised by the petitioners, at least with regard to incidents involving pets. EPA further stated in its press release that it is reviewing additional information requested by EPA from the current and former registrant regarding these incidents, and that it will use that information “along with any relevant information received during the public comment on this petition, to determine if any additional action is needed.” It will be important to monitor EPA’s review and response to this petition.