For almost a decade, EPA staff warned supervisors about reports of thousands of pets sickened and injured by Seresto flea collars. But they did nothing. Then in 2021, media reports alerted the public to 100,000 consumer complaints. They also reported more than 2,500 pet deaths. Three class action lawsuits followed. And a Congressional hearing. And several requests for recalls … that went nowhere.
And this year, Elanco settled a $15M lawsuit. It’s the company that produces Seresto flea collars. A drop in the bucket for a company that makes almost $300M annually from the Seresto flea collars.
RELATED: Seresto flea collars still selling after $15M lawsuit …
Link to come …
All this put the EPA and its actions … or inactions … under the microscope. That’s when the EPA’s Office of Inspector General (OIG) stepped in. And now a report tells all about the EPA’s shoddy safety procedures. It details EPA failures regarding the safety of pesticide products. It specifically refers to Seresto flea collars. And how those actions put pets … and their owners … at risk.
And how the EPA disagrees with the report’s main recommendation. They want to bypass the required review process looking at the Seresto product registration … which they’ve been avoiding since 2012! More about this a bit later.
Let’s start by looking at the function of the EPA and the OIG.
What Is The EPA?
The EPA, the Environmental Protection Agency, is a US governmental organization. It’s responsible for safeguarding human health and the environment. Here are some functions of the EPA:
- Regulate air and water quality standards.
- Manage hazardous waste disposal.
- Conduct environmental research and monitoring.
- Promote energy efficiency and reduce greenhouse gas emissions.
- Regulate pesticide and chemical usage (including pet products).
- Approve registration of products using pesticides.
- Enforce environmental laws and regulations.
- Collaborate with other agencies and stakeholders.
- Provide grants and funding for environmental projects.
- Educate the public on environmental issues and sustainable practices.
What is the EPA Office of the Inspector General?
The EPA Office of the Inspector General (OIG) is an independent office within the EPA. It’s funded by Congress to ensure its independence. Here’s what it does:
- The EPA Office of the Inspector General (OIG) oversees the EPA.
- It monitors the EPA to ensure it works efficiently and follows rules.
- It conducts audits, evaluations, investigations, and other reviews.
- The OIG reports to Congress.
- It prevents wrongdoing and aims to make the EPA better.
With the OIG on the job, it found the unheeded consumer complaints the most troubling.
EPA Staff Concerns Ignored For Years
The OIG looked into how the EPA responded to incidents involving these collars. It became apparent that the EPA ignored incident reports on the collar for years.
The Center for Biological Diversity (CBD) knew about Seresto flea collar complaints. In 2021 they filed a petition to have the registration of the collars canceled. In a 2024 press release the Center reported that EPA managers tried to hush staffers. The Center obtained documents and EPA emails. And EPA scientists stated their frustration with the agency’s inaction.
During one 2021 email exchange, an EPA scientist said Seresto should be removed from sale. He added that they shouldn’t use it on endangered San Joaquin kit foxes. He also wrote that a manager had told him and a colleague, “not to express our concerns about Seresto in emails.”
The concerns about Seresto flea collars should come as no surprise to the EPA. They’ve been ongoing for about 10 years as outlined in this timeline.
Timeline Of Seresto Flea Collars
This timeline starts from the introduction of Seresto flea collars:
- 2012 – Seresto collars registered with the EPA
- 2016 – Health Canada stops sale of Seresto collars in Canada after a review of toxicology studies
- 2017 – EPA officials raise concerns in emails but supervisors rebuffed them.
- 2019 – March – EPA staff raise concern to management through prepared briefings. No action taken
- July – EPA asks Bayer to make changes to safety measures and they refuse
- 2021 – Class action lawsuit filed in California
- Class action lawsuit filed in Pennsylvannia
- March – House subcommittee launches an investigation
- House subcommittee requests a recall of Seresto flea collars
- Media details reports and pet deaths linked to Seresto flea collars
- April – Center for Biological Diversity petitions EPA to cancel registration of Seresto flea collars
- 2024 – June – House subcommittee holds a hearing
- 2024 – July – EPA addresses CBD petition and completes review of incidents; outlines measures for Elanco to follow; product registration remains active.
- Sept – EPA Officer of the Inspector General (OIG) issues draft report examining the actions of the EPA
- Nov – EPA Office of Chemical Safety and Pollution Prevention provides initial response to OIG report
- 2024 – March – Elanco agrees to $15M settlement in California class action lawsuit
- EPA Officer of the Inspector General issues recommendations based on its final report: The EPA Needs to Determine Whether Seresto Pet Collars Pose an Unreasonable Risk to Pet Health
OIG Report: EPA Response Raises Safety Concerns
Media spotlight on pet deaths, consumer complaints, and complaints to the OIG hotline prompted this review.
The OIG determined the EPA approved the Seresto flea and tick product in 2012. However, in the years that followed, the report states the EPA failed to protect pets and the environment.
The report notes that the EPA followed toxicological data requirements. This was done when they registered the Seresto pet collars. But it went downhill from there. The EPA committed to do animal risk assessments, but they didn’t. Clear findings and explanations weren’t provided. Reviews overlooked the need for animal risk assessments. And they overlooked the need for public comment.
The report included these findings:
- Between 2012 and 2024, the EPA got over 100,000 incident reports related to Seresto pet collars.
- The EPA didn’t do the required reviews for Seresto product registration.
- Without reviews, the EPA didn’t assure that Seresto collars were safe for the environment and pets.
- Environmental risks from pet products are not adequately assessed.
- The EPA’s reporting process didn’t collect enough data to assess harm from pesticides.
- The lack of EPA action undermines public confidence in safety.
Another glaring concern is the EPA’s failure to follow updated safety guidelines.
EPA Follows Outdated Guideline For Safety Studies
In 2008, the Veterinary International Conference on Harmonization introduced new safety guidelines. But the EPA follows outdated guidelines from 1998. This is what’s used for assessing pet product safety. EPA scientists point out these guidelines don’t accurately measure safety margins. This was evident in incidents involving Seresto pet collars.
Pet Safety Falls Through The Cracks At EPA
The EPA continues to fall short in addressing pet safety. Interviews with Agency scientists underscore significant gaps in oversight. The report also uncovered the following:
- No dedicated office for overseeing pet safety within the EPA.
- Lack of a specific division focused on pets.
- No guidance or standard procedures for using pet incident data in risk assessments.
- Notable shortage of veterinary expertise within the agency.
So the OIG came up with 8 recommendations. The EPA agrees with 7 of them. But they disagree with #1, the most critical of all.
OIG Recommendations To Improve Safety
The Inspector General issued 8 recommendations. They directed these to the EPA’s Office of Chemical Safety and Pollution Prevention (OCSPP). This is the EPA branch overseeing the use of chemicals in pet products.
OCSPP disagreed with the first recommendation. It requires a review of the registration and safety risks of the Seresto flea collars. It also requires a review of the 2 insecticides used. The OIG requested the following:
- Issue registration review decisions for flumethrin and imidacloprid.
- Conduct domestic animal risk assessments for the 2 pesticides.
- Determine if Seresto pet collars cause unreasonable adverse effects in pets.
- Explain the Office of Pesticide Programs’ decision-making process.
- Allow public comments.
EPA Wants To Bypass Safety Review Process
But the EPA wants to bypass the registration review process. It’s something they’ve been doing since Seresto’s approval in 2012. This is in spite of requirements to the contrary. They claim in 2024, Elanco agreed to measures that ensure the collars meet EPA standards. But they didn’t provide details. And they didn’t address whether Seresto collars pose a safety risk to pets. And they don’t want public comment.
And these appear to be the ongoing problems with the EPA and the way it’s addressed Seresto flea collars all along.
EPA Seresto Pet Collar Review
The 2024 Pet Collar Review is what the EPA is standing by. It was a 2-year review in response to the 2021 petition by the Center for Biological Diversity. As noted earlier, they applied to the EPA to cancel registration of Seresto pet collars. The EPA turned down that application.
This is the same 2024 review conducted by the EPA that includes 5 FAQs. Several read like a product information statement by Elanco.
The review found that Seresto pet flea collars continue to meet EPA standards. The EPA approved Seresto collar registrations for five years. It also set out “measures” for Elanco to follow.
So … still no recalls despite 100,000 reports. And the EPA’s failure to follow its own safety procedures. And several recall demands — these come from pet owners right through to a Congressional committee.
A few years ago, an Elanco spokesperson told CBS News that they would not be issuing a recall. “That would be up to regulators,” they said.
That’s the EPA.