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Slammed for lax oversight of flea collars blamed for pet deaths, EPA seeks to hand off regulation to FDA （March 10, 2023）
The U.S. Environmental Protection Agency wants to relinquish its oversight of pet pesticide products in the wake of criticism for its handling of a popular flea and tick collar linked to more than 100,000 reports of pet injuries and deaths.
Its bid to hand the job to the Food and Drug Administration caps a tumultuous period for the EPA triggered by a March 2021 Investigate Midwest/USA TODAY investigation that showed the collar has been the subject of more incident reports than any other product in EPA history.
For years, EPA scientists have questioned the agency’s ability to regulate pet products because of how it has handled complaints about Seresto since it came on the market in 2012, according to Investigate Midwest/USA TODAY reporting. The EPA said Seresto is a “key part” but not all of the reason for the proposal.
Transferring regulation to FDA is a “potential long-term solution,” said Jake Li, EPA’s deputy assistant administrator for pesticide programs, in an interview with Investigate Midwest.
“We can't play this whack-a-mole game where every time a Seresto-like incident comes up, we have to divert our staff to it,” Li said.
Investigation:Popular flea collar linked to almost 1,700 pet deaths. The EPA has issued no warning.
The EPA has been conducting a formal review of Seresto for nearly two years and expects to finalize the updated science assessment “in the next few months, Li said, adding that the FDA helped with the assessment, both by lending staff and a framework to evaluate post-market incident data.
The work on Seresto illustrated the flaws with EPA’s process, Li said.
“In our ongoing review of Seresto incidents what really became evident to us is that, compared to FDA, we at EPA have far fewer resources, which means staff, expertise, infrastructure and funding, to evaluate animal safety and carry out the ongoing monitoring of products in the marketplace,” Li said.
Li said the EPA’s pesticide office has only two veterinarians on staff, and both were pulled from their regular duties to work on a review of Seresto “almost full time,” which slowed down their other jobs.
The Seresto review “has poached so much time out of people who are not assigned to any of this work that we believe there needs to be a much better solution for the long term,” Li said.
The agencies said in a joint whitepaper that FDA would need “significant new resources” to take over the management of the 600 topical products currently regulated by the EPA; however, the agencies said building a comparable program at EPA also would require even more resources and would be redundant with the FDA’s system.
FDA spokeswoman Veronika Pfaeffle said in an emailed statement that the current set-up doesn’t accommodate scientific advancement.
“A modernized approach that better aligns with each agency’s expertise will better protect animal health and safety and improve clarity for pet owners,” Pfaeffle said in the email.
‘FDA should be the one-stop-shop’
Under the current setup, the EPA is responsible for regulating pet pesticide products that are “not systemic,” or aren’t supposed to enter the bloodstream, while the FDA regulates “systemic” pet pesticide products, which are generally consumed by pets.
However, the agencies said in the recent whitepaper that scientists now understand that many topical flea and tick treatments, including spot-on treatments and collars, actually do enter a pet’s bloodstream, raising questions about the EPA’s product approval process.
“Both agencies agree that FDA should be the one-stop-shop for animal drugs, for these external parasite treatments and so forth,” Li said.
The EPA and FDA are holding a joint virtual public meeting, titled “Modernizing the Approach to the EPA and FDA Oversight of Certain Products,” on March 22 at 1 p.m. EDT to discuss the changes. People can register for the meeting here. The proposal is also open for a 60-day public comment period until April 24.
“Moving this forward is a good thing, but it will take years to do. This is the beginning of a very, very long process,” said Nathan Donley, environmental health science director of the Center for Biological Diversity, which petitioned to ban Seresto.
Donley expressed concern the EPA is allowing harm to continue by failing to take action on products like Seresto.
“It doesn't let the EPA off the hook,” Donley said. “They’ve got to do things now that are in their authority.”
Seresto is just one product connected to major concerns about pet and human safety. In October 2022, the EPA announced it would ban flea and tick collars containing the chemical tetrachlorvinphos, which has been linked to neurological damage in children.
EPA staff have also raised concerns in internal documents about pet products that contain fipronil, a chemical used in popular spot-on treatment Frontline Plus, which has been the subject of more than 5,000 human health incident reports, according to an Investigate Midwest review of incident data.
Review in the works for ‘years’
EPA staff sounded alarms about the safety of Seresto as early as 2015. But the agency did not launch a formal review until after the nonprofit Center for Biological Diversity filed a petition asking the agency to cancel Seresto, following Investigate Midwest's and USA TODAY’s reporting.
Last summer, a congressional subcommittee called on the EPA to cancel Seresto’s registration, noting that Canada had rejected the collar based on the EPA’s own incident data – and the EPA found an even greater link between pet death and the collar than Canadian regulators did.
More:Congressional subcommittee seeks voluntarily recall of Seresto flea and tick collar
For years, EPA and officials from Bayer and Elanco, which purchased the animal health division of Bayer – including Seresto – in 2020, met to discuss the agency’s issues with the product. In those meetings, company officials blamed other factors, including the high number of Seresto collars sold.
Elanco maintains the collar is safe based on internal studies. A company-funded analysis found that the two chemicals in Seresto – imidacloprid and flumethrin – have not been responsible for any pet deaths.
EPA scientists did multiple comparisons over the years between Seresto and other products that indicated Seresto had a higher number of pet deaths than other products, documents show. Those scientists often emailed that information, until a superior told two scientists to keep their concerns off email.
Yet the EPA did not make the public aware of any risks. The EPA’s inspector general has launched a review into the agency’s handling of incident reports associated with the product.
Li said the proposal to transfer pet-pesticide product regulation to the FDA was in the works since before the public outcry over Seresto.
“Seresto is a key part of that, but it's not the only part,” Li said. “It predates Seresto by three to four years. It's really driven by the discussion between our career staff and the FDA’s career staff.”
In a March 2021 presentation made in response to the Investigate Midwest/USA TODAY story about Seresto, EPA staff pointed out that compared to the FDA, the agency’s process is lacking. The presentation noted the EPA’s process relies on company-funded studies that use less sensitive pet breeds and small sample sizes. By comparison, the FDA has a much more comprehensive pet product regulation process, which includes pre-market clinical trials and post-market surveillance.
The EPA also has no process for evaluating pet incident reports or any trigger for when incident numbers need further review.
Documents show that EPA officials briefed Ed Messina, director of the Office of Pesticide Programs, which oversees all pesticides, on the FDA/EPA issues in March 2021, shortly after the Investigate Midwest/USA TODAY story was published.
In response, Messina attempted to reach out to the FDA, but FDA staff members declined to give Messina the email for Dr. Steven Solomon, director of the FDA’s Center for Veterinary Medicine.
“FDA counterparts don’t seem to want to give us his contact information. We don’t know what to do, it’s a very odd situation,” wrote Meredith Laws, an EPA employee.
Congressional action necessary to move forward
The proposal is taking “two separate but parallel tracks” – one for public input and one briefing Congress, Li said.
“In the end, Congress is the one who will decide whether and how to move this forward,” Li said. “We can only describe the challenges and what we're seeking directionally in terms of solutions.”
Li said the agencies are still briefing congressional committees on the proposal and aren’t yet finished.
Pfaeffle, the FDA spokeswoman, said in her emailed statement that the agencies are working with Congress on potential solutions.
“We are asking for Congress’ help to work toward a modernized approach to product oversight that increases transparency and government efficiency, aligns with each agency’s expertise and provides regulatory certainty – to stakeholders, including animal owners, industry, veterinarians and others,” the statement said.
Li said the agencies have already met with industry and environmental groups to get feedback.
“We're in the very early stages of socializing this proposal,” Li said. “We decided, let’s get this out there early and start to get some high-level feedback from folks, then adjust it and see what people say.”
Investigate Midwest (previously The Midwest Center for Investigative Reporting) is an independent, nonprofit newsroom focused on exposing dangerous and costly practices of influential agricultural corporations and institutions.
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classaction.org
in NewswirePublished on October 13, 2022
Seresto Flea Collar Class Action Alleges Bayer, Elanco Misled Pet Owners About Deadly Product
by Corrado Rizzi
Bayer and Elanco Animal Health face a proposed class action that alleges the companies have misled consumers about the safety of Seresto tick and flea collars, which have reportedly been linked to more than 2,500 pet deaths and tens of thousands of injuries and adverse event reports.
The 88-page lawsuit alleges Bayer and Elanco, who purchased the product from Bayer in 2020, have “downplayed” reports of the serious side effects of the Seresto flea collar, even after such reports became public and the collars came under regulatory scrutiny, and have continued to falsely claim that the product is safe for pets.
“At no point have Defendants disclosed this information to United States consumers,” the filing says, noting that the product’s label includes no warning that the Seresto collar may harm or kill pets, or that the product could cause any adverse side effects at all.
The case states that the danger of the Seresto collar is so severe that it sparked a Congressional inquiry by the House Committee on Oversight and Reform’s Subcommittee on Economic and Consumer Policy, who after a 16-month investigation issued a June 2022 report recommending that the Seresto flea and tick collar be recalled due to the dangers it poses to pets and humans.
According to the suit, the problem with the collars stems from a combination of the pesticides imidacloprid and flumethrin, which, together, “magnify their harmful effects.” Per the case, one retired U.S. Environmental Protection Agency (EPA) employee said the Seresto flea and tick collars “have the most incidents of any pesticide pet product she’s ever seen,” and the Congressional Subcommittee found that the product had “nearly three times the rate of total incidents, and nearly five times the rate of ‘Death’ or ‘Major’ incidents, as the second most dangerous flea and tick product.”
The lawsuit says Canada, after reviewing incident and toxicology reports, banned the sale of the Seresto collars as they posed “too great a risk to animals and humans to be safe for use.” Other countries, similarly, have required “severe warnings” to be placed on the packaging of the collar, including the word “POISON” in large font on the front label, the suit adds.
Despite Bayer and Elanco’s safety claims, Seresto collars have caused millions in damages for pet owners, both in what they overpaid for the dangerous product and in veterinarian and other medical expenses, the complaint alleges.
According to the case, Seresto flea and tick collars accounted for over $300 million in revenue for Bayer in 2019 alone. Since 2012, Bayer and Elanco have sold more than 25 million Seresto collars in the United States, the suit reports.
“Seresto pet collars are an enormous business segment, and consequently, Defendants have refused to make the product safer or warn consumers about the potential risks,” the suit reads, calling the defendants’ description of the collars as “veterinary medicine” a “misnomer.”
The plaintiff, a Bedford, Indiana resident, says that after placing Seresto collars around the necks of his two dogs, they each developed rashes and experienced lethargy. One dog developed “a cough, a heart murmur, and congestive heart failure and needed to be euthanized,” while the other “developed multiple tumors,” the lawsuit states. The consumer claims that his surviving dog’s condition has improved somewhat since he stopped using the Seresto collar.
All told, the plaintiff incurred more than $4,000 in out-of-pocket medical expenses in treating his dogs, the filing says.
Per the suit, neither the plaintiff nor other pet owners would have bought the Seresto collar had Bayer and Elanco disclosed the serious safety risks of the product.
The case looks to cover all persons in the United States who, during the fullest period allowed by law, bought a Seresto flea and tick collar for use on a pet and not for resale.
Warning: The complaint below contains graphic images of pets’ injuries.
英文 文件檔。 有 受傷犬貓的圖片
Shannon v. Bayer Healthcare LLC et al. - 1:22-cv-02003
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TOP TAKEAWAYS: Here are 5 important things to know from the new congressional investigation into Seresto collars
by Investigate Midwest staff
June 16, 2022
After 16 months of investigating, 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 — unfurled Wednesday its finding into the popular Seresto flea and tick collars and the Environmental Protection Agency’s role in regulating the collars. The collars work by slowly releasing two pesticides into pets’ fur to ward off fleas and ticks.
Elanco, the collars’ manufacturer, has maintained over the course of Investigate Midwest and USA TODAY’s reporting that the collars are safe. During a hearing Wednesday, Elanco’s president and CEO reiterated that point. (Read Elanco’s full statement here.)
Here are five important takeaways from the subcommittee’s investigation.
Seresto collars have health warnings in other countries but not the U.S. Germany’s label notes the collar poses neurological risks, and Colombia’s label calls it highly toxic. Australia’s label contains the warning: “POISON.” Canada doesn’t even allow the collar to be sold.
Seresto’s first owner, Bayer, declined to update the U.S. label after updating Germany’s to note neurological risks to pets. Bayer owned Seresto’s production before Elanco purchased the company’s animal health division in 2020. The year before, the EPA asked Bayer to update the logo to reflect the one in Germany, which noted the collar’s neurological risks to pets. Bayer said the data didn’t support a label change.
Canada found incident rates involving the collars were high. In 2015, Canadian health officials examined the collars and found Seresto had an incident rate of 36 to 65 incidents per 10,000 collars sold, including three to five “death and major” incidents. The other collars in Canada at the time of the analysis had an incident rate of 0.07 per 10,000 collars sold.
The EPA confirmed Canada’s findings, and then some. After the EPA received Canada’s analysis, it performed its own. Canadian officials had studied 251 pet deaths linked to the collars and determined 84 of them, or 33%, were “probably or possibly” caused by the collar. The EPA found that 113, or 45%, were “probably or possibly” caused by the collar.
Elanco told the EPA its collar has only been linked to 12 probable or possible pet deaths. As of summer 2021, Elanco was aware of more than 2,300 pet deaths that were linked to the Seresto collars. Its own studies found that just 0.51% were “probably or possibly” caused by the collar.
Top image: Subcommittee Chairman Rep. Raja Krishnamoorthi (D – Illinois) speaks at the June 15, 2022, hearing. He led the subcommittee’s investigation into Seresto.
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Fox 8
Seresto flea collars linked to thousands of pet deaths: Congress
by: Matt Adams
Jun 17, 2022 / 01:57 PM EDT
(WXIN) – A congressional panel has recommended the recall of flea-and-tick collars linked to 2,500 pet deaths.
The Committee on Oversight and Reform’s Subcommittee on Economic and Consumer Policy released a 24-page report this week on Seresto Flea and Tick Collars.
The findings follow a 16-month investigation into issues with the $70 collar, which is designed to protect dogs and cats from fleas and ticks. Millions of the flea collars have been sold since 2013.
Convenience is the main selling point. While most flea-and-tick treatments need to be applied monthly, the collars claimed eight months of protection for dogs and cats. They were designed to release small amounts of pesticide over the course of several months.
The product, originally made by Bayer Animal Health, which is now owned by Elanco Animal Health headquartered in Greenfield, Indiana, has been linked to 98,000 incidents involving “unexpected effects” and 2,500 pet deaths, according to the subcommittee.
Approval process
The subcommittee found the EPA rushed the collar’s approval process and employed dodgy science in doing so. The EPA first became aware of possible problems with the collar in 2015, ranking the Seresto collars No. 1 “by a wide margin” when it came to incidents with flea-and-tick products.
Seresto collars had nearly three times the number total incidents and nearly five times the rate of “deaths” or “major” incidents when compared to the second-most problematic flea-and-tick product. Canadian regulators didn’t approve the collar, ruling it posed “too great a risk to pets and their owners.”
Despite these issues, the EPA allowed the product to remain on the market, even after determining Seresto collars “probably or possibly caused 45%” of 251 pet deaths reviewed by agency.
Within the EPA, some officials voiced frustration over the continued availability of the Seresto collars and expressed relief at a report published by Midwest Center for Investigative Reporting and USA Today in March 2021.
“I hope there is a FOIA [Freedom of Information Act request] for all communications on this so that our emails are made public,” one scientist wrote. “We have been screaming about this for many years.” Another EPA official wrote that they hoped “this time someone can blow the lid off this travesty.”
Symptoms among pets, humans
Problems from the collar included lethargy, abnormal behavior, excessive grooming and vocalization, vomiting and diarrhea among pets. Irritated skin and lesions were also common. Some pets suffered from convulsions, muscle tremors or lost control of bodily movements.
Some pet owners noticed the symptoms and removed the collars early, the report indicated, citing information from Canada’s Pest Management Regulatory Agency (PMRA).
But pets were not the only ones at risk, according to PMRA findings. From 2012 through 2015, 357 pet owners reported problems stemming from the collars. According to data obtained by the PMRA from Bayer, “major” and “moderate” incidents totaled about 106 instances.
People reported things like hives and dermatitis. Some individuals experienced respiratory and neurological effects as well as dizziness, nausea or throat irritation. The problems were “probably or possibly caused by exposure to the Seresto collar,” the PMRA found.
The Canadian agency decided the only way to stop the collars from causing problems was to prohibit them from being sold in Canada. The PMRA rejected Bayer’s application to sell the product within its borders.
The EPA compiled similar data, the subcommittee found, but despite “overwhelming evidence” of potential problems, the U.S. agency approved the product and allowed it to remain on the market for years.
Downplaying the issues
In 2017, according to a whistleblower, at least one senior official with the Trump Administration tried to “tamp down” concerns over problems with the Seresto collars.
“Acting on orders from a senior EPA official, an EPA scientist instructed two other EPA officials to stop expressing their concerns about Seresto over email,” according to the report.
From the report:
In September 2018, according to documents released via a FOIA request, an EPA scientist reported 125 pet deaths linked to the Seresto collar in the second quarter of that year—“the highest number we have seen.” The scientist added that there had been 361 deaths linked to Seresto from August 30, 2017, to April 1, 2018, reflecting a trend of increasing death incidents.
Things got even worse in November 2018, when another EPA scientist shared data for the third quarter and reported 148 pet deaths. The scientist observed that the Seresto collar was “the only product where we are seeing this trend.”
EPA inaction
The report maintained that Bayer was aware of issues with the collars. Even so, the EPA proposed only “limited actions” to address the problem. The agency met with Bayer in July 2019, although it appeared nothing came from the meeting and no regulatory action took place.
Bayer rejected suggestions such as updating warning labels on the products. The labels remained unchanged. Another suggestion involved separate registrations for cat and dog collars to allow the EPA to better track data. Bayer decided the measure was too burdensome; an EPA product manager was sympathetic and agreed.
After Elanco Animal Health’s acquisition of Bayer in 2020, the Seresto collars “immediately became Elanco’s ‘top product globally,’” the report said. Bayer said it had provided its new owner with all relevant data relating to the collars.
Elanco, like Bayer, didn’t make any changes to the label in the U.S., even after the March 2021 USA Today report came to light. Seresto labels in Colombia classified the product as “highly toxic” while Australia’s label said, “POISON.”
Panel’s recommendation
Elanco, the report said, remained in denial about problems with the collars and had “taken the position that the safety and toxicity studies of the collar’s active ingredients do not support the claim that the collar could cause serious harm to animals.”
The subcommittee launched its investigation on March 17, 2021—about nine years after the collar received regulatory approval.
After the 16-month investigation, the subcommittee made three main recommendations:
Recall Seresto collars and begin the process of canceling the collar’s registration
Strengthen the EPA’s scientific review process
Improve incident data collection
“For too long, the Seresto collar has harm to many pets, and their owners,” the report concluded.
Elanco, in a March 2021 statement, said it planned to take no market action and maintained adverse events in the U.S. were below 0.3%. It said it has sold more than 25 million Seresto collars since the EPA approved the product.
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beyondpesticides.org
Coverup of Dog Deaths at EPA, According to Internal Emails on Seresto Flea and Tick Collars
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Veterinarians puzzled by flea collar angst
As scrutiny of Seresto ramps up, EPA reexamines adverse-event reports
July 7, 2022 (published)
By Lisa Wogan
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