At a Gla 24-E-0023 February 29, 2024 The EPA Needs to Determine Whether Seresto Pet Collars Pose an Unreasonable Risk to Pet Health Why We Did This Evaluation To accomplish this objective: The U.S. Environmental Protection Agency Office of Inspector General conducted this evaluation to determine whether the (1) EPA's response to reported pesticide incidents involving Seresto pet collars provides assurance that the collars can still be used without posing unreasonable adverse effects to human health and the environment and (2) EPA adhered to pesticide registration requirements in its approval of Seresto pet collars, specifically toxicological data requirements in 40 C.F.R. part 158. This evaluation is the result of multiple OIG Hotline complaints. As of August 2023, the EPA was reviewing the active ingredients, flumethrin and imidacloprid, in Seresto pet collars, pursuant to Federal Insecticide, Fungicide, and Rodenticide Act requirements. The Act mandates that the EPA determine whether a pesticide "will not generally cause unreasonable adverse effects on the environment." To support this EPA mission-related effort: • Ensuring the safety of chemicals. To address this top EPA management challenge: • Safeguarding the use and disposal of chemicals. What We Found The EPA's response to reported pesticide incidents involving Seresto pet collars has not provided assurance that they can be used without posing unreasonable adverse effects to the environment, including pets. While the EPA's Office of Pesticide Programs adhered to the toxicological data requirements in 40 C.F.R. part 158 in its initial approval of Seresto pet collars, it has not adhered to the pesticide registration review process for the active ingredients flumethrin and imidacloprid in the Seresto pet collars. The Office of Pesticide Programs did not conduct or publish domestic animal risk assessments, which it had committed to doing in the work plans for these two pesticides; continues to use an inadequate 1998 companion animal safety study (Guideline 870.7200); and lacks standard operating procedures and a measurable standard to help determine when domestic animal pesticide products pose unreasonable adverse effects to the environment, as required by the Federal Insecticide, Fungicide, and Rodenticide Act. Additionally, the EPA's Pesticide Incident Reporting System and reporting process do not capture adequate data that the EPA needs to assess unreasonable adverse effects of pet products. The EPA requested that current and former Seresto pet collar registrants provide more than the required aggregate reporting of pet incident data because of the Agency's concerns about the numerous reports of adverse incidents it had received. In July 2023, the EPA reported that it completed a review of Seresto pet collar-related incident reports and said that, in many of the death-related incidents, critical details were missing, preventing the Agency from determining the cause of the deaths. The EPA worked with the current Seresto product registrant to take measures, and the EPA limited its approval of Seresto pet collar registrations to five years. While the EPA will continue to evaluate Seresto incidents over that period, the Office of Pesticide Programs needs to prioritize several areas for improvement to ensure that pesticide products do not pose unreasonable adverse effects to pets. Pet collars containing pesticides continue to be used without assurance that there are no unreasonable adverse effects on the environment, including pets. Recommendations and Planned Agency Corrective Actions We make eight recommendations to assist the EPA in determining whether Seresto pet collars can be used without posing unreasonable adverse effects in pets. The EPA generally agreed with Recommendations 2, 3, 5, 6, 7, and 8, which are resolved with corrective actions pending. Recommendation 4 is also resolved with corrective actions completed. The EPA did not agree with Recommendation 1, which remains unresolved. Address inquiries to our public affairs office at (202) 566-2391 or OIG.PublicAffairs@epa.gov. List of OIG reports. ------- |