Congress called this week for a flea and tick collar linked to almost 100,000 pet injuries to be taken off the market — a month after doing so in a hearing.
On Monday, Rep. Raja Krishnamoorthi (D - Illinois) sent Michael Regan, the Environmental Protection Agency’s administrator, a letter summarizing the subcommittee’s 16-month investigation into the popular collars. In a hearing last month, the subcommittee unveiled its findings: The EPA knew for years the product was dangerous but hasn’t removed it from store shelves.
Krishnamoorthi asked the EPA and FDA to respond to the letter by Monday, July 25.
“We will review and respond through the appropriate channels,” an EPA spokesperson said in an email to Investigate Midwest.
Throughout the Congressional investigation and during last month’s hearing, Elanco Animal Health, Seresto’s manufacturer, has maintained the product is safe. A company-conducted study found less than 1% of 2,340 of pet deaths through mid-2021 were “probably or possibly” caused by the Seresto collars.
[Read all of our Seresto coverage here.]
That figure differs drastically from previous studies conducted by the EPA and the Canadian government. Examining 251 deaths, Canada found 45% of deaths were “probably or possibly” linked to the collars, while the EPA concluded the figure was 33%.
Elanco did not provide a comment before publication.
The EPA has said it’s conducting a review of Seresto, with assistance from the Food and Drug Administration, that it expects to wrap up in fall 2022. After the review, the agency is expected to respond to the numerous public comments — about 5,400 sources have submitted one — on the Center for Biological Diversity’s petition to take the collar off the market.
The EPA reviewed one of Seresto’s active ingredients, flumethrin, in March 2020. And, under normal circumstances, following the typical timeline for reviewing re-registration, the agency would not have reviewed flumethrin until 2035. The agency has also proposed to re-approve imidacloprid, the other active ingredient in Seresto.
The EPA currently has less than 600 full time employees working in the agency’s Office of Pesticide Programs, which oversees products that contain pesticides. That’s down from more than 800 in 2005.
Also, the office only has two veterinarians, and they have duties that extend beyond pet products.
In Monday’s letter, Krishnamoorthi reiterated the recommendations that were included in the subcommittee’s June report. Beyond calling for the collar’s cancellation, the report also recommended the agency should strengthen its scientific review process and bolster its data collection system.
The letter was also addressed to Robert Califf, the head of the Food and Drug Administration. Krishnamoori said he wants the EPA to ask for the FDA’s help.
“I am hopeful that EPA, consistent with its recognition that it lacks certain resources necessary to fully evaluate and monitor animal product safety, will engage the Food and Drug Administration—which has extensive expertise in post-market monitoring and adverse event reporting—to assist in implementing my recommendations,” he wrote in the letter.
The FDA told Investigate Midwest earlier this year that it was providing “advice and expertise” on the EPA’s review of safety data on Seresto collars. Internally, some EPA scientists expressed doubts the agency could effectively regulate the collars, leading some employees to endorse the idea of transferring regulation of the collar to the FDA.
Any transfer of regulatory authority would “likely involve stakeholder and Congressional input,” the FDA has said.
In a statement provided after publication, the FDA said it would respond directly to the subcommittee.
"The FDA and the Environmental Protection Agency share the regulatory responsibility for safe and effective flea and tick products and the FDA has an open dialogue with the EPA about how to best ensure the safety of products to control external parasites on animals," an FDA spokesperson said. "The FDA has been providing advice and expertise on EPA’s review of the post-market safety data associated with Seresto collars. Safe and effective products for controlling external parasites on animals are important for the protection of human and animal health."
UPDATED: This story was updated on Friday, July 22, to include a statement from the FDA.
Top image: Screenshot of June 15, 2022, hearing on Seresto collars. Rep. Raja Krishnamoorthi (D - Illinois) points to three different analyses of harmful incidents linked to Seresto collars: 1) Elanco's own research, 2) Canadian health authorities' and 3) the EPA's.