The company behind the popular Seresto flea-and-tick collar has filed a lengthy defense of the safety of its product amid calls for federal regulars to ban it over concerns of harm and death to the pets who wear it.
In a public comment to the Environment Protection Agency filed last month, Elanco said its collar is safe despite reports of more than 86,000 adverse incidents, including 2,340 pet deaths since it hit the market nine years ago.
Those incidents, Elanco said in its 41-page comment, are likely related to other factors and not the collar itself. Because the collar is worn for months at a time and always visible on the animal, it’s often cited in any health incident a pet has while wearing it, the Indiana-based company said.
Elanco cited its own extensive studies and investigations into those reports that they say show the collar is safe. It also noted the incident rate has declined as sales increased – from 60 reports per 10,000 collars in 2013 to 17 per 10,000 in 2020.
Elanco’s comment was one of more than 5,400 submitted in response to a petition by the Center for Biological Diversity to ban Seresto. The nonprofit filed the petition in April just weeks after a story by the Midwest Center for Investigative Reporting and USA TODAY shined a light on the high number of incident reports linked to the collar.
The EPA launched a formal review of the product in response to the petition and opened up a 60-day public comment period July 12. A Congressional subcommittee also asked Elanco to voluntarily withdraw the product. And several class-action lawsuits were filed against the company.
Read the investigation: Popular flea collar linked to almost 1,700 pet deaths. The EPA has issued no warning.
Now that the public comment period has closed, the EPA will review them as it decides whether to cancel the collar’s registration. A cancellation would mean the company can no longer use the pesticides in its collars.
The EPA has no official timetable for this process. A review by Investigate Midwest and USA Today earlier this year found that the agency often takes years to make such decisions.
Elanco, which acquired Seresto in 2020 as part of a $7.6 billion deal with Bayer, said it would not withdraw the collar from the market. Its public comment is its most extensive argument yet for why it believes its product is safe.
The company said in its filing that more than 28 million Seresto collars have been sold in the U.S. since 2012, and just a fraction of them have been the subject of incident reports. More than 93% of incidents have been classified by the EPA as “minor” or “moderate” and the pet did not suffer “any significant or permanent harm,” the company said.
Analyses by Elanco and its hired experts also found that the pesticidal action of the Seresto collar, which contains the chemicals imidacloprid and flumethrin, was not causing pets to be harmed, according to the company’s comment.
Nathan Donley, a scientist at the Center for Biological Diversity, which filed the petition that Elanco was responding to, said he was not surprised by Elanco’s comment.
“Of course Elanco’s analysis is going to show there are no problems, they would never conceivably come to any other conclusion. Companies are not capable of regulating themselves or providing any ‘evidence’ that their products are just fine and dandy. Theoretically, that’s why we have regulators. To do independent analyses without any meddling from the companies that want to keep profiting from their products,” Donley said.
Donley said the way Elanco is conducting its incident reporting rate is incorrect.
“Basically since most pets use multiple collars (at least the ones that don’t have an adverse reaction) you have to divide the number of incidents by the number of animals treated, not the number of collars sold,” Donley said.
Elanco spokeswoman Keri McGrath said that the company’s methodology “parallels EPA’s own guidance on reporting incidence rates, which ensures accurate and consistent evaluation.”
“Extensive research and nearly 33 million uses of Seresto – in the U.S. alone – have amply demonstrated Seresto’s safety profile,” McGrath said in an email.
In the public comment, Elanco also touted the benefits of Seresto, which include controlling parasites that can spread disease like Rocky Mountain Spotted Fever. The Centers for Disease Control encouraged the approval of the collar in 2012 to combat the disease.
The American Veterinary Medical Association also filed a comment, defending the continued use of the collar, saying the EPA should consider the benefits of controlling disease-causing pests.
The Veterinary Association said that the EPA, if it deems appropriate, could offer “mitigating label language” to warn about sleeping in a bed with a pet wearing the collar.
Many of the other comments were “sign-ons” to the Center for Biological Diversity’s original petition to ban the collar.
The Center also has filed Freedom of Information Act requests that have resulted in the release of thousands of internal EPA documents. Many of those documents reveal staff in the agency’s pesticide division raising concerns about the safety of the collar. Among the concerns was that Seresto was No. 1 in pet collar incident reports “by a wide margin” as far back as 2015.
The pesticide division issues approvals of the use of pesticides and monitors complaints about the pesticide.
Beyond its initial review of the product before approving its use in 2012, the EPA said it has not done a formal analysis of Seresto until now.
Elanco said that it has “been working for years with outside experts to continue to analyze and monitor incident reports for Seresto.” That analysis showed that just 12 incidents of pet death were either “probably” or “possibly” related to the collar, and those deaths were likely due to the physical nature of a collar, the company said.
“It bears repeating that the incident reports do not establish causation of an incident by a product, but only report a potential incident or health issue,” Elanco said in the comment letter.
For example, in 2020, the company sold more than 7 million Seresto collars, and during a typical year, it said, it would expect 365,000 pets to die for a variety of reasons, including old age, being hit by a car and other reasons. The company said it received 167 reports of pet deaths.
Elanco points out that the EPA has repeatedly approved the two active ingredients in Seresto, imidacloprid and flumethrin based on eight companion animal safety studies and more than 90 toxicity studies in lab animals.
Between 2012 and 2020, the EPA also received 1,153 reports of human harm, according to Elanco. Forty of those were classified as major, 400 as moderate and 713 as minor. There were no reported human deaths associated with the collar.
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.
Elanco said that the company’s analysis found that 153 of those reports were “probably” associated with the collar, and 239 were “possibly associated,” while there were 161 incidents that were “unclassifiable.”
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.