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UPDATE: Congressional subcommittee: EPA should cancel widespread Seresto collar over hyperlink to pet deaths

This story is co-published with USA TODAY.

One of the vital widespread flea and tick collars in America poses “too nice a danger to animals and people” and ought to be faraway from the market, a congressional subcommittee beneficial in a report launched Wednesday forward of its listening to titled “Seresto Flea and Tick Collars: Inspecting Why a Product Linked to Greater than 2,500 Pet Deaths Stays on the Market.”

The Home Subcommittee on Financial and Shopper Coverage, which is part of the Home Oversight Committee, the primary investigative physique within the U.S. Home of Representatives, held the listening to Wednesday afternoon. The purpose was to probe the Environmental Safety Company’s “failure to control the Seresto collar in addition to Elanco’s refusal to take motion to guard pets and their house owners from the collar’s hurt.” 

House owners of two deceased pets testified, as did former EPA scientist and coverage analyst Karen McCormack and the environmental well being science director for the nonprofit Heart for Organic Range Nathan Donley. All spoke in opposition to the pet collar.

Jeffrey Simmons, the president and CEO of Elanco, which manufactures Seresto, additionally testified. He referred to as the product secure. 

“No product is with out danger,” Simmons advised the subcommittee. “What issues is whether or not these dangers are cheap, in mild of the advantages. Quite a few research and the incident report knowledge for Seresto display the product doesn’t pose an unreasonable danger.”

Subcommittee Chairman Rep. Raja Krishnamoorthi (D – Illinois) on the June 15, 2022, listening to.

Subcommittee Chairman Rep. Raja Krishnamoorthi (D – Illinois) launched an investigation into the collar in March 2021, after reporting by Examine Midwest and USA TODAY revealed the excessive variety of incidents associated to the collar, in addition to the EPA’s inaction regardless of understanding concerning the concern for almost a decade.

“It’s unacceptable that the EPA has been conscious of the Seresto collar’s security considerations for years and has continued to permit People to unknowingly put their pets at risk by utilizing a product they’ve been led to consider is secure,” Krishnamoorthi advised Examine Midwest and USA TODAY in an announcement. 

Because it entered the U.S. market in 2012, Seresto has been linked to at the very least 98,000 opposed incidents and a couple of,500 pet deaths – essentially the most of any such product regulated by the EPA and the supply of inner alarm amongst some company workers, data beforehand obtained by USA TODAY and Examine Midwest present.

Jeffrey Simmons, Elanco’s president and CEO, nearly testifying earlier than the subcommittee on June 15, 2022.

Elanco mentioned it “unequivocally” stood behind the security of the collar.

“Quite a few research and the incident report knowledge for Seresto display the product doesn’t pose an unreasonable danger and has a robust security profile, which is why the American Veterinary Medical Affiliation opposed canceling Seresto’s EPA registration,” mentioned firm spokeswoman Keri McGrath Happe in an announcement Wednesday. (Learn Elanco’s full assertion right here.)

In an emailed assertion, EPA spokeswoman Melissa Sullivan mentioned that the EPA is conducting a evaluate of the product, with help from the Meals and Drug Administration, which it expects to wrap up in fall 2022.

“Upon finishing its evaluation and evaluation, EPA will decide whether or not these pet collar registrations can nonetheless be used safely based on the directions on the label or if further security measures or cancellations are wanted for these merchandise,” she mentioned.

The EPA didn’t reply a query about why it doesn’t have anybody scheduled to talk at as we speak’s listening to. (Learn the EPA’s full assertion right here.)

[Read more: Popular flea collar linked to almost 1,700 pet deaths. The EPA has issued no warning.]

Elanco has repeatedly defended the collar, which is its prime product, accounting for 8% of income yearly. The corporate mentioned the speed of complaints is a fraction of the general gross sales — which have surpassed 34 million previously decade — and that the speed has declined through the years. It additionally mentioned that almost all incidents are categorised as “minor” or “reasonable” and that the pet didn’t undergo “any important or everlasting hurt.”

Elanco — which purchased the complete Bayer Animal Well being unit, together with Seresto, from the German pharmaceutical big in 2020 for $7.6 billion — has mentioned its personal in depth research into the product present that the incidents of hurt reported by pet house owners are doubtless associated to different elements and never the collar itself. 

However the subcommittee’s investigation casts doubts on these claims. In a 22-page report that closely cites reporting and paperwork printed by Examine Midwest and USA TODAY, in addition to never-before-released info, the subcommittee reveals new particulars about how  Seresto “would be the most harmful flea and tick product in the marketplace” and that the EPA knew it.

For instance, as early as 2015, EPA found that Seresto had the very best fee of whole incidents in addition to dying or main incidents of any such product the company regulates. “In comparison with the second most harmful product, Seresto had almost 3 times the speed of whole incidents, and almost 5 occasions the speed of ‘Dying’ or ‘Main’ incidents. In comparison with the third most harmful product, the Seresto collar had almost 21 occasions the speed of whole incidents, and over 35 occasions the speed of ‘Dying’ or ‘Main’ incidents,” the report mentioned. 

The report additionally particulars how, in figuring out whether or not to approve the sale of Seresto in its nation, Canada’s Pest Administration Regulatory Company (PMRA) reviewed knowledge on roughly 1,000 of essentially the most critical dying and main pet incidents linked to the collar and located that it “in all probability or presumably brought on 77% of those incidents.” This led the company in 2016 to deem the collar too harmful to promote, and PMRA rejected the product’s utility whilst gross sales of Seresto continued in america. 

Among the many instances that PMRA linked to Seresto, the congressional report famous, pets skilled signs together with pores and skin issues, “lethargy, irregular habits, extreme grooming and vocalization, vomiting, diarrhea, and anorexia.” Greater than a 3rd concerned issues in “a number of organ programs,” with some experiencing “convulsions, muscle tremors, and lack of management of bodily actions.” Ten % of these pets died or had been euthanized after sporting the collar.

Faye Hemsley fought off tears through the listening to whereas describing what occurred to her canine, Tigger. Hemsley, of Huntingdon, Pennsylvania, mentioned that shortly after placing a Seresto collar on Tigger’s neck, the canine turned torpid. Shortly later, he died in her son’s arms as he was making ready to take the canine on a stroll. She mentioned she hoped her testimony may result in different individuals avoiding issues with Seresto.

“We miss him daily and the cuddles he gave us,” Hemsley mentioned.

Pet house owners, too, skilled opposed results after coming into contact with the collar, based on the congressional report. Signs included hives and dermatitis, but additionally extra critical issues like “respiratory, neurological, and digestive results, with throat irritation, respiration issue, dizziness, and nausea.”

“Notably, these noticed results on people had been in keeping with scientific research into Imidacloprid –one of many collar’s major lively elements,” the congressional report famous.

[Read more: The EPA internally raised concerns about Seresto flea collar for years, new records reveal]

The Canadian company additionally factored in Seresto’s gross sales knowledge and located that its collars had an incident fee of 36 to 65 incidents per 10,000 collars bought. PMRA considers one incident per 10,000 collars bought as indicative of a possible downside, the report said. By comparability, 15 pet collars bought in Canada on the time averaged 0.07 incidents per 10,000 collars bought.

“Seresto’s incident numbers had been additionally trending within the flawed path: PMRA expressed ‘further concern’ over the truth that Seresto’s whole incident numbers had almost doubled yearly since 2013,” based on the congressional report.

The EPA’s personal peer evaluate of Canada’s evaluation “discovered a fair stronger connection between Seresto collar use and deaths,” the report mentioned. The Canadian company had examined 251 pet deaths linked to Seresto and decided that 33% of them had been “in all probability or presumably” brought on by the collar. When the EPA independently reviewed the identical 251 pet deaths, it “concluded that 45% – or 113 – of the deaths had been in all probability or presumably brought on by the collar.”

But the EPA did nothing to warn the general public and didn’t require Bayer — and later Elanco — to do something in a different way to make its product safer or place a warning label on the packaging as international locations like Colombia and Australia had required, the congressional report famous. 

For instance, the EPA proposed in 2019 that Bayer separate its registrations for the collar in order that there was one for cats and one for canines. The rationale being that the EPA may higher analyze incident knowledge for the completely different merchandise. Bayer rejected this proposal, citing the executive burden it could trigger. The EPA thanked the corporate for its consideration and backed down, based on the congressional report. 

The EPA additionally requested Bayer to replace Seresto’s warning label because it had carried out in different international locations. Germany’s label, for instance, notes the collar poses neurological dangers; Colombia’s label calls it extremely poisonous; Australia’s label merely says “POISON.” Bayer, and later Elanco, refused this proposal, and the label remained unchanged, the report mentioned.

At one level, Simmons mentioned Elanco can be prepared to work with the EPA on science-supported adjustments to its labeling, however its research into Seresto present the product shouldn’t be dangerous.

The product’s “worth is critical,” he mentioned. “The chance is affordable.”

“With all respect, Mr. Simmons, it is not your job to determine if the chance is affordable,” Rep. Katie Porter (D-California) replied. “That’s the job of the regulatory physique. 

“My concern is that (Elanco) is standing in the way in which of permitting the EPA to assemble these essential knowledge and make that essential resolution,” she continued. “I encourage Elanco to work with the EPA to get this knowledge, and in the event that they gained’t, then Seresto must come off the market. Too many households have suffered already.”

The congressional report additionally states that paperwork obtained by the subcommittee “present that Bayer and Elanco relied on doubtful justifications to clarify opposed incidents brought on by the Seresto collar” and referred to as into query its declare concerning the “Weber impact.”

The Weber Impact is a principle that “the variety of incidents linked to a product will peak on the finish of the second yr after regulatory approval, adopted by a gentle decline because the market turns into aware of the product,” the report states. However when Bayer continued to make use of this justification throughout a July 2019 assembly between the corporate and the EPA, reported animal deaths had continued to climb every of the seven years the collar had been in the marketplace.

However Elanco mentioned in an announcement to USA TODAY and Examine Midwest that the speed of incident reviews has been reducing. Based on the corporate’s personal numbers, McGrath Happe mentioned, the speed was 17.26 per 10,000 collars bought in 2021.

“That’s lower than a fifth of 1% reporting fee across-the-board,” she mentioned. “Greater than 93% of incident reviews acquired for Seresto pet collars within the U.S. from January 2013 to December 2021 are categorised after cautious evaluation as ‘minor’ (70.65%) or ‘reasonable’ (22.59%), with the overwhelming majority being redness or irritation on the website of the collar. In analyzing all reviews, the info present no established hyperlink between the lively elements in Seresto and pet dying.”

Krishnamoorthi mentioned that Elanco’s science didn’t move the scent check, when in comparison with EPA and PMRA findings. 

When requested about this discrepancy, Donley mentioned it’s frequent {that a} third-party guide would discover completely different outcomes.

“In the event you’re profiting off of one thing then you definitely’re more likely to discover it a lot safer than an unbiased scientist would,” he mentioned.

Along with its calls for that Elanco voluntarily recall its collar and the EPA cancel the product’s registration, the subcommittee additionally recommends that the EPA change the way in which it collects incident knowledge and allocates essential assets to research these incidents.

“Following the Subcommittee’s disturbing findings,” Krishnamoorthi mentioned, “I consider the EPA should develop its knowledge assortment requirements and extra strictly observe its scientific evaluate course of to make sure that harmful merchandise should not permitted to remain in the marketplace and threaten the welfare of pets that so many People view as household.”

Rep. Hank Johnson (D – Georgia) expressed disappointment that the EPA has did not take motion for years, and it was solely after the general public realized about Seresto’s harms by way of media reviews and a petition to cancel by the Heart for Organic Range that the EPA took any motion.

“When it got here to defending man’s finest good friend,” he mentioned, “we could not rely on the EPA.”

UPDATE: This story was up to date quickly after publication with remark from Elanco. This story was up to date twice within the afternoon following publication with info from the Congressional listening to.

Prime picture: Throughout a June 15, 2022, listening to on Seresto collars, Rep. Raja Krishnamoorthi (D – Illinois) factors to 3 completely different analyses of dangerous incidents linked to the collars: 1) Elanco’s personal analysis, 2) Canadian well being authorities’ analysis and three) the EPA’s.

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