House panel: EPA should cancel Seresto pet collars
One of the most popular flea and tick collars in America poses “too great a risk to animals and humans” and should be removed from the market, a congressional subcommittee recommended in a report released Wednesday before its hearing.
The House Subcommittee on Economic and Consumer Policy, part of the House Oversight Committee, the main investigative body in the U.S. House of Representatives, held the hearing Wednesday afternoon to probe the Environmental Protection Agency’s “failure to regulate the Seresto collar as well as Elanco’s refusal to take action to protect pets and their owners from the collar’s harm.”
Six witnesses testified, including the owners of two deceased pets, former EPA scientist and policy analyst Karen McCormack and the environmental health science director for the nonprofit Center for Biological Diversity, Nathan Donley. All spoke against the pet collar.
Jeffrey Simmons, president and CEO of Elanco, the company that manufactures Seresto, called the product safe in his testimony.
“No product is without risk,” Simmons told the subcommittee. “What matters is whether those risks are reasonable, in light of the benefits. Numerous studies and the incident report data for Seresto demonstrate the product does not pose an unreasonable risk.”
Rep. Raja Krishnamoorthi, D-Ill., who chairs the panel, launched an investigation into the collar in March 2021 after Investigate Midwest and USA TODAY revealed the high number of incidents related to the collar, as well as the EPA’s inaction despite knowing about the issue for nearly a decade.
“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,” Krishnamoorthi told Investigate Midwest and USA TODAY before the hearing.
Since it entered the U.S. market in 2012, Seresto has been linked to at least 98,000 adverse incidents and 2,500 pet deaths – the most of any such product regulated by the EPA and the source of internal alarm among some agency employees, records obtained by USA TODAY and Investigate Midwest show.
In an email, EPA spokeswoman Melissa Sullivan said the agency is conducting a review of the product, assisted by the Food and Drug Administration, which it expects to wrap up in fall 2022.
“Upon completing its analysis and assessment, EPA will determine whether these pet collar registrations can still be used safely according to the instructions on the label or if additional safety measures or cancellations are needed for these products,” she said.
Elanco – which bought the Bayer Animal Health unit, including Seresto, from the German pharmaceutical giant in 2020 for $7.6 billion – said its own extensive studies into the product show that the incidents of harm reported by pet owners are probably related to other factors and not the collar itself.
The subcommittee’s investigation casts doubts on those claims. In a 22-page report, the subcommittee said Seresto “may be the most dangerous flea and tick product on the market” and the EPA has known it for years.
In 2015, the EPA discovered that Seresto had the highest rate of total incidents, as well as death or major incidents, of any such product the agency regulates. “Compared to the second most dangerous product, Seresto had nearly three times the rate of total incidents, and nearly five times the rate of ‘Death’ or ‘Major’ incidents,” the report said.
The report detailed how, in determining whether to approve the sale of Seresto, Canada’s Pest Management Regulatory Agency (PMRA) reviewed data on roughly 1,000 of the most serious death and major pet incidents linked to the collar and found that it “probably or possibly caused 77% of these incidents.” This led the agency in 2016 to deem the collar too dangerous to sell.
Among the cases that PMRA linked to Seresto, the congressional report noted, pets experienced skin problems, “lethargy, abnormal behavior, excessive grooming and vocalization, vomiting, diarrhea, and anorexia.” More than a third of cases involved problems in “multiple organ systems,” and some animals experienced “convulsions, muscle tremors, and loss of control of bodily movements.”
Pet owners, too, experienced adverse effects after coming into contact with the collar, according to the congressional report.
“Notably, these observed effects on humans were consistent with clinical studies into Imidacloprid – one of the collar’s main active ingredients,” the congressional report said.
The Canadian agency factored in Seresto’s sales data and found that its collars had an incident rate of 36 to 65 incidents per 10,000 collars sold. PMRA considers one incident per 10,000 collars sold as indicative of a potential problem, the report stated. By comparison, 15 pet collars sold in Canada at the time averaged 0.07 incidents per 10,000 collars sold.
The EPA’s peer review of Canada’s analysis “found an even stronger connection between Seresto collar use and deaths,” the report said. The Canadian agency examined 251 pet deaths linked to Seresto and determined that 33% were “probably or possibly” caused by the collar. When the EPA independently reviewed the same deaths, it “concluded that 45% – or 113 – of the deaths were probably or possibly caused by the collar.”
The EPA did nothing to warn the public and did not require Bayer – or Elanco – to do anything differently to make its product safer or place a warning label on the packaging, the report noted.
The EPA proposed in 2019 that Bayer separate its registrations for the collar, so there was one for cats and one for dogs, the rationale being that the EPA could better analyze incident data for the different products. Bayer rejected the proposal.
The EPA asked Bayer to update Seresto’s warning label as it had done in other countries. Germany’s label notes the collar poses neurological risks; Colombia’s label calls it highly toxic; Australia’s label simply says “POISON.” Bayer and Elanco refused the proposal.
In addition to its demands that Elanco voluntarily recall its collar and the EPA cancel the product’s registration, the subcommittee recommended that the EPA change how it collects incident data and allocates resources to investigate incidents.
“Following the subcommittee’s disturbing findings,” Krishnamoorthi said, “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.”