A federal regulatory agency has asked the EPA to review whether Seresto collars are safe for pets, but so far the agency has not done so.
A federal regulator told the U.S. Environmental Protection Agency (EPA) this month that its regulatory oversight of Seresto’s flea and tick collars, blamed for the deaths of more than 2,000 pets, was not “adequate.”
The federal investigation into Seresto collars began in 2021 after Investigate Midwest and USA TODAY revealed that the collar was linked to tens of thousands of health conditions, including skin rashes in people. The EPA ultimately allowed Seresto to continue to be sold, but ordered that a warning label be added to the product.
In February, however, the Office of the Inspector General told the EPA that it needed to determine whether “Seresto pet collars pose a disproportionate risk to the health of companion animals.” Despite this review, the EPA “has not provided any assurance” that the collar is safe, the inspector general concluded.
To achieve that goal, the agency’s inspector general recommended reopening the review process for Seresto’s two active ingredients. This would essentially determine whether the pesticides are safe enough to be sold in the United States and would allow for public comment on the collars.
The EPA has refused to follow the regulator’s recommendation. While the review process is the standard way a pesticide gets to market, the EPA has other mechanisms in place to address concerns about products, the agency told the Office of the Inspector General in response to its February report.
In 2023, the agency published the results of an investigation into the collar. The EPA ultimately decided that the collar could remain on the market, with stricter reporting requirements for the manufacturer of Seresto. The agency said this investigation was consistent with the intent of the recommendation.
On August 7, the supervisory authority published its response.
“Overall, the agency’s response does not adequately address” how it will regulate the Seresto collars, the inspector general’s office said. In particular, the fact that Seresto is not being made available for public comment is a “deficiency” that is “inconsistent with EPA’s standard practices,” it added.
In a statement to Investigate Midwest on Friday, the EPA reiterated that the new requirements placed on Seresto’s manufacturer, Elanco Animal Health, would be sufficient to ensure the safety of pets.
“Based on this analysis and to continue registration, Elanco has implemented several new labeling and reporting requirements to improve the safety of this product,” the EPA said. “The goal of these actions is to continue to allow products on the market that protect pets while minimizing the risk associated with the use of Seresto collars.”
Elanco did not respond to a request for comment. The company has maintained that the collar is safe and denies that injury cases reported to the EPA are evidence of a hazard. German conglomerate Bayer sold its entire animal health unit, which originally produced Seresto collars, to Elanco for $7.6 billion in 2020.
“Elanco continues to fully support Seresto’s safety profile as a proven solution for protecting dogs and cats from fleas and ticks,” an Elanco spokesperson told Investigate Midwest in 2022. “We support all of the agency’s review processes.”
Internally, the EPA noted years ago that incidents involving Seresto collars were a concern. In 2015, agency officials said Seresto was “No. 1 by a wide margin” compared to other flea and tick collars, Investigate Midwest and USA TODAY reported.
Still, the agency did not review the collar until the number of incidents was widely reported in the press in 2021. When the story broke, an EPA biologist emailed a colleague, “Looks like the shit is hitting the fan. … We’ve been screaming about (Seresto) for many years.”
Findings of the Inspector General
The Inspector General began his investigation into the EPA’s handling of Seresto collars in May 2022 and released his findings in February of this year.
This includes:
When reviewing the registration of Seresto’s active ingredients, the EPA did not assess whether the pesticides posed a risk to pets. The agency had originally committed to doing so, but ultimately did not do so, according to the Inspector General’s report. The active ingredients are flumethrin and imidacloprid.
The agency told the Office of the Inspector General that it did not have the “expertise and resources” to assess toxicity to animals. It also did not have standards to assess the risk to pets, it said.
The EPA said its scientific review, published in 2023, was “the equivalent” of an assessment of the risks to pets.
The protocol on which the EPA relied when originally approving the ingredients in the Seresto collar does not meet “international standards.” The protocol followed by the EPA dates back to 1998, although other countries have more recent guidelines.
“The staff we interviewed indicated that this was not a priority,” the Office of the Inspector General wrote. A longtime EPA scientist called the use of the 1998 protocol “a ‘glaring weakness’ that was made publicly apparent with the Seresto pet collar incidents.”
The data collected by the EPA on incidents related to the use of pesticides are “insufficient to determine unreasonable adverse effects.” For example, no descriptive information about incidents is collected that would help the agency assess the toxicity of a pesticide.
EPA staff told the Office of the Inspector General that the data on the incidents was “unreliable… underestimated and the data quality questionable.”
The EPA has already asked Elanco to provide more information about Seresto incidents than other companies, including “critical details about deaths, adequate follow-up of all reported deaths, and information about a pet’s health status” before it wore the collar, the EPA said.
The EPA lacks a standard procedure for reviewing risks to pets, and the Office of the Inspector General was unclear about who is responsible for reviewing risks to pets. An agency official said a lack of veterinary expertise is likely contributing to the problem.
Seresto timeline
In early 2021, Investigate Midwest and USA TODAY revealed that Seresto’s flea and tick collars were linked to tens of thousands of claims, including nearly 1,700 pet deaths over several years. But there was no warning label on the product.
A month later, the EPA announced it was reviewing the collar. While the review was taking place, the House Subcommittee on Economic and Consumer Policy launched its own investigation. At the time, the subcommittee was part of the House Oversight Committee, the U.S. House’s main investigative body, and was led by Representative Raja Krishnamoorthi, Democrat of Illinois. (The subcommittee no longer exists.)
In the summer of 2022, shortly after the EPA’s inspector general announced its investigation, the House subcommittee released the results of its investigation, noting that other countries require a warning label for Seresto and that Canada had banned the collar after authorities there found a high number of harm cases. The subcommittee called on the EPA to ban Seresto.
About a year later, in July 2023, the EPA announced that it had completed its investigation into the Seresto collar. It could still be sold, but the EPA took corrective action. Elanco had to add a warning label and was only granted a 5-year approval. Normally, pesticides are approved for 15 years before manufacturers must apply for continued use.
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