A federal watchdog this month told the Environmental Protection Agency that its regulatory oversight of Seresto flea-and-tick collars, which have been linked to more than 2,000 pet deaths, was not “adequate.”
Federal scrutiny of the Seresto collars started in 2021, after Investigate Midwest and USA TODAY revealed the collar was linked to tens of thousands of incidents of harm, including rashes on humans. The EPA ultimately allowed Seresto to continue to be sold, but the agency ordered a warning label to be added to the product.
However, in February, the EPA’s Office of Inspector General told the EPA it needed to determine whether “Seresto pet collars pose an unreasonable risk to pet health.” Despite its review, the EPA has “not provided assurance” the collar is safe, the inspector general concluded.
To accomplish that goal, the inspector general recommended the agency re-open the review process for the two active ingredients in Seresto — essentially, this would determine whether the pesticides were safe enough to be sold in the U.S. This would also allow for public comment on the collars.
The EPA has declined to follow the watchdog’s recommendation. While the review process is the standard way a pesticide makes it to market, the EPA has other mechanisms to address concerns with products, the agency told the inspector general’s office in response to its February report.
For instance, in 2023, the agency released the results of an inquiry into the collar. The EPA ultimately decided the collar could stay on the market, with more reporting requirements for Seresto’s maker. The agency said this inquiry satisfied the recommendation’s intent.
On Aug. 7, the watchdog published its response.
“Overall, the agency’s response does not adequately address” how it will regulate the Seresto collars, according to the inspector general’s office. In particular, not opening Seresto up for public comment is a “deficiency” that is “inconsistent” with the 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 maker, Elanco Animal Health, were enough to keep pets safe.
“Based on this analysis and in order to continue the registration, Elanco implemented several new labeling and reporting requirements to improve the safety of this product,” the EPA said. “The goal of these mitigations is to continue to allow products on the market that can protect pets while minimizing risk associated with the use of Seresto collars.”
Elanco did not return a request for comment. The company has maintained the collar is safe, and it disputed that incidents of harm reported to the EPA equaled evidence of danger. Bayer, the German conglomerate, sold its entire animal health unit, which originally produced Seresto collars, to Elanco in 2020 for $7.6 billion.
“Elanco unequivocally continues to stand behind the safety profile of Seresto as a proven solution to help protect dogs and cats from fleas and ticks,” an Elanco spokesperson told Investigate Midwest in 2022. “We support all agency review processes.”
Internally, the EPA identified incidents related to Seresto collars as a cause for concern years ago. In 2015, agency officials said Seresto’s incident counts “ranked #1 by a wide margin” compared to other flea-and-tick collars, Investigate Midwest and USA TODAY reported.
Despite that, the agency did not review the collar until the number of incidents was reported widely in the press in 2021. Once the story was out, an EPA biologist emailed a colleague, “Looks like the sh** has hit the fan. … We have been screaming about (Seresto) for many years.”
Inspector general’s findings
The inspector general started its probe into the EPA’s handling of Seresto collars in May 2022. In February of this year, it released its findings.
These include:
When the EPA conducted its registration review of Seresto’s active ingredients, it did not assess whether the pesticides posed a risk to pets. The agency originally committed to do this, but it ultimately did not, according to the inspector general’s report. The active ingredients are flumethrin and imidacloprid.
The agency told the inspector general’s office it does not have the “expertise and resources” to assess the toxicity to animals. It also has no standards to assess the risk to pets, it said.
The EPA said its scientific review, released in 2023, was the “equivalent” of assessing the risks posed to pets.
The protocol the EPA relied on when it originally approved the ingredients in the Seresto collar is not “up to international standards.” The protocol the EPA follows is from 1998, despite other countries following more recent guidelines.
“Staff we interviewed indicated this was not a priority,” the inspector general’s office wrote. One longtime EPA scientist called using the 1998 protocol “a ‘glaring weakness’ that has become publicly obvious with the Seresto pet collar incidents.”
The data the EPA collects on incidents related to pesticide exposure is “inadequate to determine unreasonable adverse effects.” For instance, it does not capture any narrative information on incidents that would help the agency assess a pesticide’s toxicity.
EPA staff told the inspector general’s office the incident data is “unreliable … there is underreporting, and data quality is suspect.”
The EPA has already asked Elanco to provide more information than other companies related to incidents involving Seresto. This includes “critical details on death incidents, adequate case follow up on any reported deaths, and information on a pet’s health status” before it wore the collar, the EPA said.
The EPA lacks a standard operating procedure for reviewing the risks to pets, and it was unclear to the inspector general’s office where the responsibility for reviewing risks to pets resides. One agency official said a lack of veterinary expertise likely contributes to the issue.
Seresto timeline
In early 2021, Investigate Midwest and USA TODAY revealed that the Seresto flea-and-tick collars were linked to tens of thousands of incidents of harm, including almost 1,700 pet deaths over several years. But the product carried no warning.
A month later, the EPA announced it was reviewing the collar. As the review happened, 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 main investigative body of the U.S. House of Representatives, and was chaired by Rep. Raja Krishnamoorthi, D-Illinois. (The subcommittee no longer exists.)
In summer 2022, shortly after the EPA’s inspector general announced its probe, the House subcommittee released the findings of its investigation. It found other countries require Seresto to come with a warning label, and that Canada banned the collar after authorities there found a high rate of incidents of harm. The subcommittee called on the EPA to ban Seresto.
About a year later, in July 2023, the EPA announced it had completed its inquiry of the Seresto collar. It could still be sold, but the EPA placed mitigation measures in place. Elanco was required to add a warning label, and it was only granted a 5-year registration. Normally, pesticides are approved for 15 years before producers need to apply for their continued use.
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