This story is co-published with USA TODAY and is embargoed for republication until Oct. 4, 2021.
For nearly a year during the pandemic - as people were acquiring more pets and spending more time with them - the Environmental Protection Agency did not know that pet owners had filed about 11,000 complaints about the safety of the Seresto flea and tick collar
When the EPA did notice in March of this year that it had not received any complaint reports from Elanco - the maker of the product - it reached out to Elanco, which quickly submitted the reports. Elanco said it had been submitting hard copy reports through UPS last year, but the reports were returned by the carrier because the EPA offices were closed.
In addition, an EPA employee had told Elanco last year to hold the reports, according to agency emails.
The delay in submission reports, which the EPA said was caused by a misunderstanding on when and how the reports should be submitted during the pandemic, meant that the EPA was unaware of the continuing stream of complaints that have now totaled more than 86,000 since the product was introduced into the market in 2012. Incidents include seizures, skin irritations and even deaths among cats and dogs that were wearing the collar.
EPA emails obtained through a public records request show the agency’s pesticide incident coordinator noting the lack of reports.
“It's strange," Robert Miller wrote on March 10 to a colleague. "Elanco sent us incident reports for other products but not for Seresto."
The agency reached out to Elanco on March 10, and the company promptly submitted the incidents electronically.
EPA spokesman Ken Labbe told the Midwest Center and USA TODAY last week that Elanco had misunderstood the agency’s directive and should have been delivering those reports all along.
“In mid-March (2020), EPA informed registrants of pet spot-on products to hold their submissions for sales and incident data because EPA did not have mail service due to the pandemic,” Labbe said in an email. “Elanco, interpreted this to mean all 6(a)(2) data should be temporarily held for all products, including for collars. This misunderstanding was quickly resolved, and the data were submitted by Elanco for Seresto upon request.”
But Elanco, which purchased Seresto from Bayer in August last year, said it was the agency itself which directed the company to suspend filing the reports due to the pandemic.
Elanco spokeswoman Keri McGrath said Bayer had been sending hard copy reports to the EPA, but when the pandemic started, the agency’s offices closed and the reports were returned by the mail carrier. She said the company continued to send them anyway as a precaution, even though they were returned.
“The reports you referenced, which cover March 2020 through present, were submitted via an electronic method following communications from the EPA,” said spokeswoman Keri McGrath in an email.
A June 22, 2020, email shows Bayer telling EPA employee Elizabeth Fertich about the returned reports and asked for further instructions. Fertich responded that everyone was “teleworking due to Covid 19, therefore, no one is in the building to accept packages.”
Fertich told the company to hold the reports and check back in a month.
Another email among EPA employees on March 10 confirmed the company was told to hold the reports until the office reopened.
“Not sure who gave that directive, but most people thought COVID would be over in a few months from when it started,” wrote Kimberly Smith, a branch chief in the registration division. "No one knew it would still be here a year later and counting."
The emails were part of numerous public records provided by the EPA in response to a lawsuit filed by the nonprofit Center for Biological Diversity for the release of the records. The organization also petitioned the EPA to ban Seresto this spring.
More incidents than any other product
Like other flea and tick collars, the Seresto collar works by releasing small amounts of pesticide onto the animal for months at a time. The pesticide is supposed to kill fleas, ticks and other pests but be safe for cats and dogs.
But Seresto, which uses the pesticides imidacloprid and flumethrin, has been the subject of more incidents of harm than any other product in EPA history, according to internal agency emails.
In the years since Seresto was brought to market, EPA staff members repeatedly raised concerns about the reports and called representatives of Bayer in for meetings on multiple occasions to discuss what could be done to mitigate the harm. But the public was never warned about any dangers the collar may pose.
The investigation by USA TODAY and the Midwest Center for Investigative Reporting prompted inquiries to the EPA by a congressional oversight committee and the office of Sen. Bernie Sanders, I-Vt. It also triggered a series of class action lawsuits.
“The EPA appears to be turning a blind eye to this problem," said Karen McCormack, a retired EPA employee who worked as both a scientist and communications officer, in an interview with a reporter earlier this year. “But I think this is a significant problem that needs to be addressed sooner rather than later.”
Elanco has vigorously defended the safety of its pet collar.
McGrath said that global data shows that 1 in 568 users of Seresto have an incident and “the majority of these incident reports relate to non-serious effects such as application site disorders, e.g. a reddening of the skin or hair loss below the collar.”
“Keep in mind that the existence of an adverse event report does not necessarily mean the product caused the problem,” she said. “Causality between the observed signs and the use of the product is evaluated on a case-by-case basis. That said, every adverse event collected, regardless of causality, is reported to the authorities.”
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It’s not just pets, though, EPA documents show.
Between 2013 and 2018, 907 incidents were reported with humans, according to a September 2019 EPA assessment of human health risk.
The assessment determined that there were 19 severe incidents. Of those, eight people had dermal symptoms, such as a rash or hives, and seven had neurological symptoms, which included numbness and headaches.
Incidents listed by the EPA included:
- A 12-year-old boy who slept in a bed with a dog wearing a collar started having seizures and vomiting. He had to be hospitalized.
- A 67-year-old woman who slept in a bed with a dog wearing a collar reported having heart arrhythmia and fatigue.
- A 43-year-old man put collars on eight dogs and slept in the same bed as four of the dogs. A week later, he developed ear drainage and nasal and throat irritation and was told by a doctor that he had a hole in his ear drum. He removed the dog collars and the symptoms went away. He later reapplied the collars and the symptoms returned.
In a September response to the attempted ban of Seresto, Elanco told the EPA that reporting rates for humans were extremely low – less than one incident per 50,000 – and that few of these incidents were likely connected to the collar.
“[T] he data make clear that there is no reason to revisit EPA’s prior determination that Seresto is safe for its intended use, benefits millions of animals (and their families), and that those benefits outweigh any possible risks.”
The EPA has also noted “that large numbers of incident reports may simply reflect a large product sales volume or the existence of toll-free 800 numbers on product labels, making incident reporting easier.”
And an October 2016 EPA bulletin responded to citizen concerns about children being exposed to Seresto, saying it had found exposure to the collars to be negligible.
Nevertheless, the bulletin stated: “As stated in the precautions on the label, do not allow children to play with the collars. In addition, try to keep the pet away from young children for a day after putting on the collar to minimize exposure.”
Editor's note: This story has been updated with new information that shows Elanco was instructed by an employee at the Environmental Protection Agency to hold its incident reports until the EPA offices, which were closed during the pandemic, reopened. (The company continued to submit the reports by mail, but they were returned by mail carrier.) The updated story also now includes a statement from an EPA spokesman that says Elanco misunderstood the agency's directive.
This story is a collaboration between USA TODAY and the Midwest Center for Investigative Reporting. The Center is an independent, nonprofit newsroom covering agribusiness, Big Ag and related issues. USA TODAY is funding a fellowship at the center for expanded coverage of agribusiness and its impact on communities.