Jul 30, 2022
Seresto Flea and Tick Collars for dogs and cats have been sold to Americans since 2013. During that time, the EPA has received approximately 100,000 reports of illnesses and 2,500 reports of deaths of animals that wore a Seresto Flea and Tick collar, by far the most reports received about any flea and tick treatment on the market. In this episode, hear testimony from scientists about the Environmental Protection Agency’s disturbingly lax review processes for pesticides in pet products and learn why your vote in November is likely to determine if these popular but dangerous products will stay on American shelves.
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To report an incident directly to the EPA via email Report.Pesticide.Incident@epa.gov
Bruce Bueno de Mesquita and Alastair Smith. The Dictator's Handbook: Why Bad Behavior is Almost Always Good Politics. Public Affairs: 2011.
“Oversight Subcommittee Report Reveals EPA Failed to Protect Pets, Owners From Dangerous Flea and Tick Collar.” Jun 15, 2022. House Committee on Oversight and Reform.
House Committee on Oversight and Reform, Subcommittee on Economic and Consumer Policy. June 2022. “Staff Report: Seresto Flea and Tick Collars: Examining why a product linked to more than 2,500 pet deaths remains on the market.”
Johnathan Hettinger. Sept. 24, 2021. “Is your pet wearing a Seresto flea collar? Company reports thousands more adverse incidents.” USA Today.
Jordan Liles. Mar 8, 2021. “Did Seresto Flea Collars Cause 1,698 Dog and Cat Deaths?” Snopes.
Johnathan Hettinger. Mar 2, 2021. “Popular flea collar linked to almost 1,700 pet deaths. The EPA has issued no warning.” USA Today.
Lawrence J. Dyckman et al. July 1995. “Pesticides: EPA’s Efforts to Collect and Take Action on Exposure Incident Data, GAO/RCED-95-163.” U.S. Government Accountability Office.
“Lobbyist Profile: Ryan Canfield.” 2022. Open Secrets.
“Employment History: Ryan Canfield.” Open Secrets.
“Elanco Animal Health.” Open Secrets.
Faye Hemsley & Omarion Hemsley, Owners of
Thomas Maiorino, Owner of Deceased Pet
Jeffrey Simmons, President and Chief Executive Officer, Elanco Animal Health Incorporated
Nathan Donley, Ph.D, Environmental Health Science Director, Center for Biological Diversity
Karen McCormack, Former Scientist, Policy Analyst, and Communications Officer (ret.), Office of Pesticide Programs, Environmental Protection Agency
Carrie Sheffield (minority witness), Senior Policy Analyst, Independent Women’s Voice
1:20 Rep. Raja Krishnamoorthi (D-IL): As early as 2015, just a few years after the collar entered the US market, an EPA investigation found that among similar products, the Seresto collar “ranked number one” by a wide margin in terms of total incidents, major incidents and deaths, even after factoring in companies’ relative sales. Those findings weren't enough to drive the makers of Seresto collar or the EPA to act.
1:50 Rep. Raja Krishnamoorthi (D-IL): In 2016, Canada's equivalent of the EPA known as the PMRA, concluded based on a review of the same American data available to the EPA that the collar posed too great a risk to pets and their owners to be ever sold in Canada.
2:10 Rep. Raja Krishnamoorthi (D-IL): Even as the death count rose, the EPA allowed Seresto to remain on the market here without even so much as requiring additional warning labels that regulators mandated in places ranging from Australia to Colombia to the European Union.
2:30 Rep. Raja Krishnamoorthi (D-IL): The companies that manufactured the Seresto collar first Bayer animal health and then later Elanco were also aware of the risks, the incidents and the deaths, but they too failed to act. Instead, they hired third party industry insiders to conduct so-called independent reviews of the incident data, which ended up protecting their $300 million a year market but ended up endangering pets. So the Seresto collar stayed the same and so did the consequences.
4:15 Rep. Raja Krishnamoorthi (D-IL): This particular collar has caused 100,000 incidents reported to the EPA and over 2500 pet deaths reported to the EPA.
4:30 Rep. Raja Krishnamoorthi (D-IL): The steps that we are asking for today are crucial, because it's important to protect our pets and our families, too. I now call upon my distinguished colleague, Mr. Cloud for his opening statement. Rep. Michael Cloud (R-TX): Thank you, Chairman. This is the first hearing of the Economic and Consumer Policy Subcommittee this year, and we've been in session for 52 days this year. And our first hearing is on pet collars. And I do realize that our pets are a huge part of our lives, they enrich our families, they provide companionship for my kids, they've helped foster responsibility and compassion and care, important ethics we need in our society. Just recently, our family mourned the loss of our guinea pig, biscuit. And so pets are a huge part of our family lives. But I have to admit that when I saw that this was going to be on the agenda for this week, I cannot help but be concerned, especially coming from South Texas about the 1000s 10s of 1000s of human lives that have passed away due to fentanyl and due to an open border and due to the policies of this administration to continue to aid and abet cartels. And I realized that this is the economic and Consumer Policy Subcommittee. And so I think about economic policy happening right now and where the minds of the American people are. Gas is now averaging $5 A gallon nationwide. For the first time in history. We have not had a hearing. Inflation is at a 40 year high. We have not had a hearing, the American people cannot find baby formula. We still haven't had a hearing. I've mentioned fentanyl is killing Americans, especially our teens at unprecedented rates. We have not had a hearing. Biden's systemic elimination of the safe and secure border he inherited has led to the worst humanitarian and national security crisis in this country's history. We have not had a hearing this term, we could talk about how inflation is affecting the cost of owning a pet, including the increased cost of food, toys, accessories, but we're not talking about that either. Instead, we're holding a hearing on the pet collar, which fights fleas and ticks. And as any pet owner knows fleas and tick management is an essential part of pet care. But I'm not sure it's an essential part of congressional oversight, especially when we take in mind where the American people are at. And frankly, I've talked to a number of people in my district and others who live in other parts of the country and they are really surprised that this has risen to one of the top priorities of commerce at this time in juncture. The subcommittee Republicans would rather explore efforts to help American consumers during these trying times, we would gladly have joined the chairman in holding a hearing on the shortage of baby formula. Moreover, we have welcomed the chance to explore TikTok’s troubling practice of showing dangerous content to minors, an investigation you all started last year. In fact, it's now come to light that teenagers are using tick tock and other social media platforms to purchase illicit drugs including unknowingly in many cases, in most cases, fentanyl. Social media platforms are also using it to recruit young people into the gig economy of human trafficking. A hearing on that crisis could be incredibly important. And on the subject of our nation's youth, CDC bureaucrats have actively pursued an agenda to close schools during the pandemic instead of following the science damaging our children's financial, mental, physical, emotional, and also their learning for years to come. But we still have not had a hearing. Americans are facing incredible economic issues which require us as elected officials to listen and to respond. I do appreciate the fact that our pets play an important part of our lives. We should be kind to animals and we should teach our children to do the same. But I do care immensely more about the human lives that we were elected to serve.
10:20 Rep. Raja Krishnamoorthi (D-IL): A recorded vote has been requested — we will pause while the we will get the clerk out.
12:00 Rep. Byron Donalds (R-FL): Mr. Chairman, it's already been about what? A minute and a half. Where's the clerk? Is the clerk on lunch and not here today? Rep. Krishnamoorthi (D-IL): I think the clerk is on the way Mr. Donalds, thank you. Rep. Donalds: Is the clerk sitting in the side office just hanging out? I mean, come on, Mr. Chairman.
21:20 Clerk: Mr. Cloud? Rep. Michael Cloud (R-TX): Yes Clerk: Mr. Cloud votes yes. Mr. Keller? Rep. Fred Keller (R-PA): Yes Clerk: Mr. Keller votes yes. Mr. Franklin? Rep. C. Scott Franklin (R-FL): Yes Clerk: Mr. Franklin votes yes. Mr. Clyde? Rep. Andrew Clyde (R-GA): Yes. Clerk: Mr. Clyde votes yes. Mr. Donalds? Rep. Byron Donalds (R-FL): Yes Clerk: Mr. Donalds votes yes.
26:31 Thomas Maiorino: My name is Thomas Maiorina. I reside in Mount Laurel, New Jersey with my wife Monica. I am the father of three boys. My youngest son, Robert turned 12 in 2011. After years of asking for a dog, he wore us down and we decided to rescue a dog from a southern shelter for my son's birthday. After researching online, we adopted a mixed breed mutt that Robbie and his two other brothers named Rooney. Rooney swiftly became a loved member of our family. A bit rambunctious, she was just what a 12 year old boy needed. She loved the run and chase anything the move in the yard. By all measures, we took great care to ensure Rooney had a healthy and happy life. We took her on daily walks, sometimes three a day, hikes on park trails. We monitor her diet and made sure she was seen by the veterinarian as needed, and she received all of her shots. Because she was a bit rambunctious and we lived in a wooded area where there's a lot of wildlife, we were constantly concerned about the problems of fleas and ticks. We consulted with a veterinarian after getting Rooney to determine the best way to protect her against this. We use a variety of prevention methods for the first few years and when we changed veterinarians in approximately 2013 or 14, the new veterinarian strongly recommended that we use the Seresto flea and tick collar, based on all of our options. We heeded that advice and purchased Seresto collars from our local PetSmart. The collars were intended to provide protection for up to eight months. We noticed that after fixing a collar to Rooney’s neck, she began to itch and first had that treated and tested for allergies. We took her to the vet several times during 2018 seeking to find the cause for the ever increasing itching. After several visits and multielement medications, they were unable to determine the cause and we switched to a specialist in 2019 to seek further assistance, where they provided allergy shots and other medications to address the worsening itching and related symptoms. Rooney's behavior then became more erratic as the months wore on she began linking her paws so feverishly they would bleed. She also developed bleeding patches on her stomach. Ultimately, in October 2020, Rooney suffered horrendous grand mal seizure in the presence of myself and my wife. The damage done by the seizure was irreversible. She was a shell of her former self and ultimately, the family decided the most humane thing would be to put Rooney to sleep at the age of nine. In early March 2021, I read an article online about Seresto pet collars resulting in the deaths of 1700 Pets without any warnings from the EPA or the manufacturer. I sought out legal representation not because I wanted financial compensation, but because I took great pains to care for Rooney. The final 18 months of her life were agonizing to watch if I could help prevent another family from going through what my family went through. I wanted to act. I'm here today in furtherance of that effort. I appreciate the committee taking the time to investigate this matter. And thank you for your time.
33:30 Jeffrey Simmons: There are a few points I'd like to emphasize upfront. First, the EPA approved Seresto following more than 80 safety and toxicity studies, all of which show that Seresto and its ingredients have a strong safety profile. Second, more than 80 regulatory bodies around the world have approved Seresto. Seresto is widely used and more than 80 million collars worn over the past decade to protect dogs and cats from fleas and ticks around the world.
34:00 Jeffrey Simmons: Third, adverse event reports are not intended to be, and in fact are absolutely not, proof of causation. Reports require further investigation and analysis to determine cause. And after years of review, our pharmacovigilance team made up of veterinarians and other experts who study adverse event reports has not identified a single death caused by the active ingredients in the collar.
36:45 Jeffrey Simmons: No product is without risk. What matters is whether those risks are reasonable. And in light of the benefits and numerous studies and the incident report data for Seresto demonstrate the product does not pose an unreasonable risk and has a strong safety profile, which is why the American Veterinary Medical Association opposed canceling Seresto’s EPA registration.
38:05 Nathan Donley: My name is Dr. Nathan Donley. I'm the science director for the Environmental Health Program at the Center for Biological Diversity. I have a PhD in Cell and Developmental Biology from Oregon Health and Sciences University. The last seven years of my professional life have been spent researching how pesticides impact people and the environment and the regulatory failures that can actually facilitate harm rather than prevent it. I published three peer reviewed scientific articles and five technical reports on this subject. I've authored over 100 technical scientific comments to the EPA on pesticide documents, including flumethrin and imidacloprid, the two active ingredients in the Seresto collar. I've read through 1000s of pages of FOIA documents I requested on matters related to the approval and continued use of Seresto.
39:40 Nathan Donley: While other agencies like the FDA have robust systems in place to surveil harms from products under their purview, EPA only requires minimal information be submitted four times a year and they delegate this responsibility to the pesticide industry itself. The limited information that is collected includes only the pesticide product name, where the incident occurred, and the severity of the incident. That's it. Oftentimes, the agency doesn't even know if the incident involves a dog or a cat. Even though the EPA determines what incident information it collects, it then turns around and laments that the incident data are insufficient to take regulatory action to protect public health, the environment and our pets. It's a system designed to achieve nothing other than maintaining the status quo. Worse yet, reported incidents significantly underestimate the true scope of harm. The EPA recently estimated that only one in 25 pesticide incidents involving another pesticide called Kamba was actually reported to the authorities. That's only a 4% reporting rate. Given that 100,000 people have reported their concerns about Seresto, this is very alarming because the true number of harmful incidents to pets could be potentially far higher.
41:05 Nathan Donley: The EPA’s counterpart in Canada was so concerned about Seresto incidents and harms of pets and humans that it denied Seresto approval in 2016. Canada analyzed U incident data and determined that Seresto collars had an incident rate 50 times greater than the average flea collar and 36 times greater than Canada's trigger for review.
41:25 Nathan Donley: EPA has no trigger for review of any pesticide product, no matter how much harm is being reported. And because the agency has no mandated trigger for reviewing pesticides like Seresto, rather than choosing to use incident reporting data to inform a robust regulatory process and take dangerous products off the market, EPA routinely chooses to do nothing at all. And that's especially troubling when you consider that Seresto is just one of 18,000 pesticide products currently approved by the EPA.
42:40 Karen McCormack: My name is Karen McCormack. At the present time I am a retired government employee after working over 40 years at the Environmental Protection Agency. During my career at EPA, I first worked in an EPA laboratory as a research coordinator. And in that capacity, I conducted research on numerous pesticides. Later I transferred to EPA headquarters in Washington DC, and worked in various positions in the pesticide program as a scientist, policy analyst, and a communications officer. I also worked in a number of offices at EPA including the Office of the Assistant Administrator for Pesticides and Toxins. Although I'm retired from EPA, I'm still closely following a number of environmental topics and one of those topics of interest to me has been the impact of flea and tick pet products on cats and dogs.
43:30 Karen McCormack: The US Environmental Protection Agency is charged with regulating products that contain pesticides and in ensuring that all pesticide products are safe to use. Before 1996, EPA did not consistently require manufacturers to conduct animal safety studies for pet products containing pesticides. Because pet products with pesticides were available readily in commercial stores, consumers thought they must be safe. This is not necessarily the case. Flea and tick products are designed to kill insects, and they often contain poisonous chemicals. When combined with pesticides that are used outside the home and in the water and food that people drink and eat, the aggregate risks from all these sources of pesticides can be high, especially for children who are vulnerable to toxic chemicals -- much more vulnerable than adults. And it wasn't until the passage of the 1996 Food Quality Protection Act that EPA began to examine the risks from sources other than food, including risks from pet products containing pesticides. After the passage of FQPA, pesticide manufacturers were required to submit to EPA animal safety studies and incident reports showing harm to animals and humans exposed to pesticides and pet products. Between 2012 and the present time the EPA received an increasing number of incident reports related to the use of flea and tick pet collars for dogs and cats. The toxic effects that were described in these many incident reports from the use of certain pet collars ranged from mild effects, such as skin irritation to more severe effects such as intense tremors, seizures, paralysis, organ failure and death. The largest number of incident rate counts that EPA received during this period were from the use of pet collar called Seresto.
45:35 Karen McCormack: Between January 2012 and the present time, EPA has received over 100,000 incident reports, and these incident reports include human incidents as well as pet incidents. These reports also include at least 2300 reports of pet deaths. The number is most likely a very low estimate of the actual number of incidents that are occurring since many pet owners do not know that they can report incidents to EPA and they may not know how to correlate the adverse effects in their pets with a particular pet product.
46:30 Karen McCormack: There are no independent organizations that rank the safety of pet products. And the sales data which is needed to rank the safety of pet products is considered confidential business information by the manufacturers. EPA’s risk assessments also do not tell the full story of what pet products are safe, as they rely heavily on industry generated studies that were conducted on mice and rats rather than dogs and cats. And EPA’s risk assessments also are based mainly on studies that were conducted with only one pesticide in Seresto rather than the combined pesticides in this pet product.
47:10 Karen McCormack: Although the original manufacturers of Seresto, Bayer, did conduct a number of efficacy and safety studies in dogs and cats treated with Seresto, the company did not conduct two very critical studies that are important for determining the safety of a pet product. These tests include a pet transferable residue study, a petting study, to determine the exposure of humans to Seresto. And they did not conduct a study that measures the amount of pesticide that gets in the blood of treated dogs and cats.
48:45 Carrie Sheffield: My name is Carrie Sheffield and I'm a senior policy analyst at the Center for Economic Opportunity at Independent Women's Forum. We are a nonprofit organization committed to increasing the number of women who value free markets and personal liberty.
2:44:20 Rep. Raja Krishnamoorthi (D-IL): Let me just show you some analysis that was conducted by Elanco, which we would just refer to as well as the EPA, as well as the Canadian equivalent of the EPA, which is called the PMRA. Essentially, we look at this chart here, and we see that at the top Elanco computed that 0.51% of pet deaths were “possibly or probably” caused by the Seresto collar. The PMRA in Canada, looking at a sample of pet deaths concluded that 33% of those pet deaths were possibly or probably caused by Seresto collars. And the EPA here, concluded that 45% were possibly or probably caused by pet by the Seresto collar. Now, sir, I think originally, you said that there is no scientific evidence, no evidence of a causal link, this is clearly evidence, it was so compelling that the Canadian equivalent of the EPA never allowed for Seresto collars to be sold in Canada, correct? Jeffrey Simmons: Yes, I'm aware of that decision. I would also add that 80 other countries have approved this product, we've had over 80 million collars actually used. I'm not familiar with this data comparison, but what I can say is following the EPA regulatory process around the oversight, that we have pharmacovigilance, close to 200 veterinarians and staff on our team, looking at the data through the way the EPA wants us to we have not seen a linkage from the active ingredients. Rep. Krishnamoorthi: I understand that sir, I understand you haven't seen the linkage, although other authorities have and their scientists who are not paid by you have done so.
2:46:25 Nathan Donley: This is what we commonly see, quite frankly, when the regulated industry is doing their own research. It commonly finds that their products are safer than when government agencies or academic scientists take on a similar analysis.
2:46:55 Rep. Raja Krishnamoorthi (D-IL): We have FOIA documents from the EPA, and emails internal to the EPA talking about the Seresto collar. Here's just one of them. This is from an employee who basically voiced their opinion about recent coverage of the Seresto controversy, he said, “looks like the sh*t has hit the fan….will be interesting seeing where this goes. I hope there is a FOIA for all communications on this so that our emails are made public. We have been screaming about Seresto for many years.” I presume that you've heard some of these screams and concerns, correct, Ms. McCormack? Karen McCormack: That's correct. A number of EPA employees have contacted me and given me detailed descriptions about what's happening with Seresto and they were very upset that EPA refused to do anything about it.
2:48:25 Karen McCormack: A number of the scientists, and this is not unusual, feel that the decision makers are not considering the science and they're making decisions based on political reasons. I don't know if I have time to talk about this, but I did look at the science that the Canadian government did, the causality analysis. They looked at the consistency and toxicity of effects from exposure of pets to Seresto. And what they found was very disturbing. It was so disturbing that they decided the risks were too high to approve Seresto and they could not be mitigated by putting a label statement on the product or by issuing warning labels, so they refused to approve Seresto.
2:49:25 Rep. Michael Cloud (R-TX): Thank you, Ms. McCormack, for acknowledging that the EPA sometimes makes political decisions, so that's something we'll definitely be coming back to next term.
2:55:05 Rep. Katie Porter (D-CA): Are the active ingredients for Seresto in the United States different from the active ingredients for Seresto collars in other countries? Jeffrey Simmons: No, I do not believe they're any different than the other 80 countries. Rep. Porter: In other countries like in Colombia and Australia, the warning labels for Seresto collars classify the collar as highly toxic and as poison.
2:55:50 Rep. Katie Porter (D-CA): Does the label in the United States have language? Like highly toxic or poison? Yes or no? Jeffrey Simmons: It does not. Rep. Porter: Okay. So the warning label here in the United States, though does say that mild reactions may occur and mentions hair loss, scratching and redness. The most severe symptoms listed are eczema and lesions. This is the warning label: does it mention the potential for death? Jeffrey Simmons: It does not. Rep. Porter: So a pet owner looking at this label that we're looking at would have absolutely no reason, no way to know that Seresto may have caused roughly 100 pet deaths. That's what both the Canadian Pest Management Agency, the PMRA, and the EPA found. Will you change this label, so that it includes deaths as a possible side effect? Jeffrey Simmons: Congresswoman, we do not believe the scientific data warrants a label change. And again, that is not just the 80 studies were submitted. There's been 20 additional added studies since and all of the oversight data that's been done on the 33 million pets over the 10 years. So again, following an EPA regulated process, we're always open if a data warranted, some need for a change, we would do that.
2:57:30 Rep. Katie Porter (D-CA): The EPA encouraged both your predecessor, Bayer, and your company, Elanco, to update the warning label. Yet, you just said that you never have. So the federal government did in fact advise you to update the label and you failed to do so. Is that correct? Jeffrey Simmons: I do not believe that is correct. We are in regular engagement with EPA. We have not received any formal…there's no data that warrants that and there's been no formal engagement on that.
2:58:15 Rep. Katie Porter (D-CA): The EPA asked Bayer, the predecessor here, in 2019 to help the agency collect data on adverse incidents for cats and dogs using the Seresto collar. EPA asked Bayer to split the registration for cats and dogs, so the agency could better understand and evaluate the risks for each type of pet. They refused, saying that change might have, “an adverse impact on sales” and they also said, “it would be a substantial increase in work.” Mr. Simmons, are you willing to make that change and split the registration for cats and dogs as the EPA requested? Or do you believe it's too much work? Jeffrey Simmons: I am willing to engage with the EPA on anything that the scientific data and the engagement under the regulatory body of the EPA merits the right thing to do. We believe the 80 studies and all of the pharmacovigilance data that we've submitted to them stands that this is a safe product.
3:00:10 Rep. Andrew Clyde (R-GA): I feel obligated to begin by stating the obvious this afternoon. Today's hearing is a colossal waste of time and resources.
3:13:25 Rep. Henry Johnson (D-GA): And the only reason that the public knew about the harm caused by this pesticide is because the Center for Biological Diversity publicly petitioned the EPA to cancel registration for Seresto flea collars. If they had not bought this to light, do you think we would even know of the dangers presented by these collars? Nathan Donley: No, we wouldn't. You know, the investigation that came out in USA Today in 2021 really brought this to the public attention. And if there wasn't that amount of pressure from the public, this would just still be completely unknown. EPA, for the last 10 years, has not done anything to alert consumers to the harms associated with this product or any other pesticide products where there are a very high number of incidents.
3:15:10 Karen McCormack: I think some of the people at EPA are programmed to go along with whatever industry says. It makes life easier for you, you can go home earlier and you can also get promoted easier if you go along with what industry says. It's unfortunate a problem there. And I've seen it over the years and it's very hard to do something about it.
3:15:40 Karen McCormack: Canada's analysis was very scientific. It was not only based on incident data and sales data, it was based on the toxicity of the two pesticides in Seresto. And they looked at the consistency and what happened eventually with the pets that were exposed to Seresto.
3:19:20 Rep. Raja Krishnamoorthi (D-IL): And so because of the tremendous number of pet incidents, the tremendous number of deaths, even when factoring in sales, I sadly have no choice but to recommend that the EPA commence a notice of intent to cancel proceedings and to fully investigate what's going on with the Seresto collar, and I respectfully request Elanco to voluntarily recall these collars at this time, pending this further investigation.
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