Oversight Subcommittee Report Reveals EPA Failed to Protect Pets, Owners From Dangerous Flea and Tick Collar
Washington, D.C. (June 15, 2022)—Today, Rep. Raja Krishnamoorthi, Chairman of the Subcommittee on Economic and Consumer Policy, released a staff report entitled “Seresto Flea and Tick Collars: Examining Why a Product Linked to More than 2,500 Pet Deaths Remains on the Market,” which details the findings of the Subcommittee’s 16-month investigation into the safety of the Seresto flea and tick collar. The report reveals that the Environmental Protection Agency (EPA) under previous administrations was aware of the dangers of the Seresto collar as early as 2015 and failed to take action to protect pets and their owners. Scientific experts, a former EPA official, and pet owners will testify about the dangers of the Seresto collar and the findings of the Subcommittee’s report at a hearing this afternoon.
“It is unacceptable that the EPA has been aware of the Seresto collar’s safety concerns for years and has continued to allow Americans to unknowingly put their pets in danger by using a product they have been led to believe is safe,” said Chairman Krishnamoorthi. “While I am pleased by the EPA’s new commitment to revisit the incident data, I urge the agency to initiate formal Notice of Intent to Cancel proceedings to determine whether the Seresto collar should be removed from the market, including a comprehensive cost-benefit review of its serious risks. Following the Subcommittee’s disturbing findings, I believe the EPA must expand its data collection standards and more strictly follow its scientific review process to ensure that dangerous products are not permitted to stay on the market and threaten the welfare of pets that so many Americans view as family.”
The Seresto flea and tick collar received EPA approval in 2012 and was introduced to the market in 2013. Since then, Bayer—the original brand owner of the collar—and Elanco—which purchased the product in 2020, have sold more than 30 million collars. Pet owners embraced the convenience of the product, which provides 8 months of flea and tick protection for dogs and cats for under $70, and which is widely sold by pet specialty stores, online pet pharmacies, and large online retailers.
The Subcommittee launched its investigation into the collars in March 2021, following the publication of an investigative report which revealed that, as of June 2020, there had been more than 75,000 incidents and approximately 1,700 pet deaths linked to the Seresto collar. Since then, the reported numbers have increased to more than 98,000 incidents and 2,500 pet deaths.
The Subcommittee reviewed emails from the EPA, as well as documents from Bayer and Elanco, that showed the EPA was aware of these incident numbers and the dangers caused by the collar yet failed to act. Documents and communications obtained by the Subcommittee reveal:
- EPA Rushed Seresto’s Approval Through a Flawed Scientific Review Process: An EPA Risk Manager wrote in 2016 that the agency “rushed” the Seresto collar’s registration so that the CDC could use the collars in a study. The California Department of Pesticide Regulation found that key studies that tested the Seresto collar on adult dogs and cats were not acceptable because the studies “greatly under-estimated the exposures” to one of the collar’s active ingredients. EPA’s product manager for Seresto also observed that other required studies for pesticide products had small sample sizes and tested the pesticides on “hardy breeds,” limiting the studies’ usefulness.
- EPA First Discovered Serious Issues with the Collar’s Safety in 2015: A 2015 EPA investigation found that “Seresto ranked #1 by a wide margin” in terms of total incidents and “Death” or “Major” incidents among flea and tick products. EPA found that, adjusted for sales figures, the Seresto collar had nearly three times the rate of total incidents, and nearly five times the rate of “Death” or “Major” incidents, as the second most dangerous flea and tick product. The collar had nearly 21 times the rate of total incidents, and over 35 times the rate of “Death” or “Major” incidents, as the third most dangerous product.
- Canada Refused to Allow the Collar to be Sold Due to Safety Concerns: According to information obtained by the Subcommittee, in 2016, Canada’s Pest Management Regulatory Agency (PMRA) concluded—based on a review of U.S. incidents and toxicology studies—that the collar posed too great a risk to pets and their owners to be sold in Canada. PMRA expressed great concern over the “number and severity” of U.S. animal incidents linked to the Seresto collar. The Canadian agency reviewed enhanced data on roughly 1,000 of the most serious “Death and Major” pet incidents linked to Seresto, and found that the collar probably or possibly caused 77% of these incidents.
- EPA Allowed the Collar to Stay on the Market: EPA’s independent review of the complete incident data for Seresto “had largely the same overall impressions as PMRA’s” analysis. Canada’s PMRA reviewed 251 pet deaths linked to the Seresto collar and found that the collar probably or possibly caused 33% of those deaths. EPA independently reviewed the same 251 pet deaths and concluded that the collar probably or possibly caused 45% of those deaths. Yet EPA let the Seresto collar remain on the market—even after high incident numbers continued in recent years.
- EPA Officials Voiced Frustrations over the Seresto Collar Remaining on the Market: Previously released documents show that, during internal deliberations over how to respond to an inquiry about the collar following the March 2021 USA Today investigative report, an EPA scientist stated that the substance of the agency’s reply would “depend if you want the real answer or some talking points to cover our ass for doing nothing.” The same scientist separately observed to other colleagues, “Looks like the sh** has hit the fan. There are lots of news and public advocate sites that have picked up on the Seresto story in USA Today. Will be interesting seeing where this goes. I hope there is a FOIA for all communications on this so that our emails are made public. We have been screaming about this for many years.” Another EPA official wrote that they hoped “this time someone can blow the lid off this travesty.”
- Reported Incident Figures May Understate the Harm Caused By the Seresto Collar: By EPA’s own admission, there “is undoubtedly some degree of underreporting in every incident database regularly used by” the agency’s pesticide office. Many incidents go undetected or unreported because, as EPA has explained, the “[s]ymptoms associated with pesticide poisonings are often vague or mimic other causes leading to incorrect diagnoses.” Further, EPA generally only requires companies to provide minimal pet incident data—total incident numbers, and whether the incidents were deaths, major, moderate, or minor incidents—with no information on pets’ symptoms, age or health status, or length of exposure to the pesticide. EPA received only this minimal, aggregate data for Seresto from 2016 until 2020. From April 2020 until the USA Today report was published in March 2021—a period that included the closing of Elanco’s August 2020 purchase of Bayer Animal Health (and, in turn, the Seresto collar)—EPA did not receive a single Seresto incident report from either company.
Despite the unprecedented number of incidents related to the Seresto collar, its manufacturer, Elanco, has refused to voluntarily recall the product. EPA’s Office of Inspector General (OIG), meanwhile, has recently announced plans to evaluate the agency’s response to reported Seresto incidents. In light of the information obtained in this investigation and in order to protect pets and their owners from this dangerous product, the Subcommittee’s staff report makes the following recommendations:
- Begin Proceedings to Cancel the Seresto Collar’s Registration: Canada’s PMRA concluded in 2016—based on U.S. incident data—that the Seresto collar posed too great a risk to animals and humans to be safe for use. EPA agreed with PMRA’s underlying findings and analysis, and EPA officials have expressed concerns about the collar’s safety for years. Accordingly, EPA should initiate a Notice of Intent to Cancel proceedings, which will ensure that a comprehensive review of Seresto and its risks is undertaken. In the meantime, to protect pets from further harm, Elanco should institute a voluntary recall of the Seresto collar until comprehensive safety testing can be completed.
- Strengthen the Scientific Review Process: EPA should revamp and strictly follow its Registration Review process for pesticide products. The Agency should update its guidelines for companion animal safety studies so that they are better able to detect adverse effects. Likewise, EPA should require that scientific studies have adequate sample sizes and use animals that are as similar as possible to the animals that will ultimately be exposed to the pesticide product.
- Improve Incident Data Collection: EPA must improve its data collection to better understand the risks posed by the pet products it regulates. This should include information on the symptoms that animals experience, the circumstances in which the pesticide exposures occurred, and the species, sex, age, and health status of the affected animals. EPA should consider placing its contact information on all pet products under the Agency’s jurisdiction, so that consumers can directly make detailed reports to EPA when an incident occurs. In turn, EPA should ensure that the relevant offices in the Agency have the resources necessary to collect, document, and analyze these reports.
Click here to read the staff report.