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Daily News Blog

06
Mar

Inspector General Finds Widely Used Flea Collars Still Not Fully Evaluated by EPA 

dog and child sleeping together

(Beyond Pesticides, March 6, 2024) With over 2,500 pet deaths and 900 reports of adverse effects to people, an Office of Inspector General (OIG) report, published on February 29, 2024, reveals multiple systemic failures by the U.S. Environmental Protection Agency’s (EPA) Office of Pesticide Programs (OPP), citing inadequate safety reviews of Seresto pet collars. The report, The EPA Needs to Determine Whether Seresto Pet Collars Pose an Unreasonable Risk to Pet Health, concludes, “The EPA’s response to reported pesticide incidents involving Seresto pet collars has not provided assurance that they can be used without posing unreasonable adverse effects to the environment, including pets.” At the time the animal effects made headlines in 2021, the agency defended the product’s registration, telling the media that, despite these incidents, EPA deemed Seresto collars “‘eligible for continued registration’ based on best available science, including incident data… No pesticide is completely without harm, but EPA ensures that there are measures on the product label that reduce risk.” Despite the scathing criticism, EPA maintains the position that it conducted an adequate review of the two active insecticide ingredients in the pet collars—the neurotoxic insecticide flumethrin, and the notorious neonicotinoid imidacloprid—proven to have adverse effects on the endocrine system as environmental contaminants. 

In the report, the OIG states, “Specifically, the OPP [Office of Pesticide Programs] did not conduct domestic animal risk assessments for either flumethrin or imidacloprid as it had committed to do in initial and final work plans for both pesticides. Furthermore, according to a long-tenured EPA scientist we interviewed, the EPA’s 1998 Guideline 870.7200 for companion animal safety studies is inadequate, and the OPP lacks standard operating procedures and a methodology to help determine when pet products may pose unreasonable adverse effects to the environment.” With this statement, the report calls out EPA for its failure to adequately assess the safety of Seresto flea and tick collars, originally formulated by Bayer and now manufactured by Elanco. The OIG demands that EPA, “Issue amended proposed interim registration review decisions for both flumethrin and imidacloprid that include domestic animal risk assessments for flumethrin and imidacloprid; written determinations on whether the Seresto pet collar poses unreasonable adverse effects in pets; and an explanation of how the Office of Pesticide Programs came to its determinations. Allow for public comment by placing these documents in the applicable registration review dockets.” EPA defends its process and points to mitigation measures it adopted and announced in July 2023. The agency says that it was unable to determine the cause of the animal deaths, except for some possible mechanical strangulations that were associated with a failure of the collar’s release mechanism. However, the agency did find some neurological effects and struck an agreement with Elanco to issue label warnings and improve the quality of incident data collected by the manufacturer. 

The New Lede reported, “The (Seresto) collars have been the subject of more than 105,354 incident reports, including the 3,000 pet deaths, more than any other EPA regulated product in history, according to the EPA’s incident database.” The OIG investigation began in response to these and “nearly 900 reports of human pesticide incidents related to the Seresto pet collars” received from 2012 through 2022.  

Synergistic Effects of Flumethrin and Immidacloprid Not Evaluated 

As Beyond Pesticides previously reported, Seresto collars are plastic pet collars embedded with pesticides designed to kill fleas, ticks, and lice by emitting the poisons from the collar; they contain the active ingredients flumethrin and imidacloprid. Flumethrin, a chemical in the pyrethroid class of synthetic neurotoxic insecticides, has been linked repeatedly to neurological issues, such as seizures and learning disabilities in children, to gastrointestinal distress, and to damage to invertebrates, according to EPA’s own analysis  In a March 2021 call to action, Beyond Pesticides reported that a 2012 study found [flumethrin and imidacloprid] have a synergistic effect, meaning they are more toxic together on fleas. However, EPA consistently fails to evaluate synergistic effects of pesticides, a 2016 EPA bulletin concluded: “The risk of the combination of the two active ingredients, flumethrin and imidacloprid, was not assessed because the two chemicals act in completely different ways.” Similarly, as Beyond Pesticides has pointed out repeatedly, EPA does not do an adequate job of evaluating the risks and harms of exposures to multiple pesticide compounds, as well as those of so-called  “inert” or “other” pesticide ingredients that are not disclosed on the product label. 
 
As the OIG report discovered in its findings, EPA demonstrated:  

  • Lack of Adherence to Registration Process: The EPA’s Office of Pesticide Programs (OPP) has failed to adhere to certain aspects of the pesticide registration review process for the active ingredients, flumethrin and imidacloprid, in Seresto collars. Specifically, the OPP did not conduct domestic animal risk assessments as initially planned, as required by their work plans for both pesticides. This failure raises concerns about the agency’s commitment to ensuring the safety of pet products. 
     
  • Inadequate Guidelines and Procedures: The OPP lacks standard operating procedures and a methodology to determine when pet products may pose unreasonable adverse effects to the environment. According to a long-tenured EPA scientist, the agency’s 1998 Guideline 870.7200 for companion animal safety studies is inadequate and described “as a “glaring weakness” that has become publicly obvious with the Seresto pet collar incidents. More efficient, advanced, and accurate methods for ensuring a margin of safety have been developed.”    
     
  • Incomplete Incident Data Collection: The EPA has collected incident data related to Seresto pet collars through its Incident Data System (IDS). However, the IDS does not capture all the necessary data for the agency to assess the unreasonable adverse effects of pet products. This incomplete data collection hampers the EPA’s ability to fully understand the risks associated with Seresto collars and take appropriate action. 
     
  • Lack of Public Assurance: The EPA’s lack of action in response to reported incident data and its failure to capture comprehensive data through the IDS does not provide the public with sufficient assurance that Seresto pet collars are safe for use. The agency’s inaction raises concerns about its commitment to protecting the environment and the well-being of pets. 

The OIG report notes, “ [T}he U.S. House of Representatives Committee on Oversight and Government Reform, which is now the Committee on Oversight and Accountability, Subcommittee on Economic and Consumer Policy launched an investigation…in 2022, the subcommittee released a report of its investigation, which outlined the EPA’s awareness of these incidents and the potential harm caused by the collars and the EPA’s own conclusion after an independent review conducted in 2016 that the collars “probably or possibly” caused 45 percent of the reported pet deaths.” 

The measures EPA announced after its July 2023 review include the following: 

  • Adding label warnings on common adverse effects that have been reported, along with instructions to remove the collar if those effects occur and on how to report the incident.  
  • Requiring the registrant to report incident and sales data on an annual basis and provide additional information about incidents whenever possible.  
  • Improving the quality of data reported when receiving reported incidents from consumers. 

The committee’s report also highlighted that the Seresto collar was banned in Canada following an assessment by federal regulators. The assessment concluded that the collar “probably or possibly” caused 77% of reported incidents categorized as “death” or “major” when used on pets. 

OIG Report Recommendations 

The OIG report makes eight recommendations, which include directing the EPA to improve data gathering and update the EPA’s Incident Data System so that it can “adequately assess incident reports and make timely decisions,” implement procedures for how to conduct domestic animal risk assessments, a measurable standard to determine when a pet product poses unreasonable adverse effects, and update EPA’s 1998 Guideline for Companion Animal Safety to align with international standards.  The first OIG recommendation directs the EPA to revise and issue interim registration review decisions for flumethrin and imidacloprid, perform risk assessments for domestic animals and issue written determination of the Seresto pet collar’s safety. It also asks for an account of the decision-making process by the Office of Pesticide Programs and to enable public feedback by including these documents in the relevant review dockets.

Unsurprisingly, the EPA’s Office of Chemical Safety and Pollution Prevention (OCSPP) claimed they had satisfied this recommendation with actions taken on July 13, 2023, implying no further action was necessary. The OIG pointed out that the EPA’s response missed the recommendation intent. The OIG highlighted that the EPA did not use the formal process required for reviewing these products (interim pesticide registration and a domestic animal risk analysis), did not allow for public comments, and did not conclusively determine the safety of the Seresto collars as advised by issuing a determination on whether the Seresto pet collar poses unreasonable adverse effects in pets. This recommendation remains unresolved and the OIG directs EPA to submit “its responses concerning specific actions in process or alternative corrective actions proposed on the recommendation” within 60 days.

EPA’s other substantive response was to point to a February 2023 joint white paper by the EPA and Food and Drug Administration (FDA) titled “A Modern Approach to EPA and FDA Product Oversight,” which discusses moving regulatory jurisdiction over pet collars and roughly 600 other topical pet products from the EPA to the FDA.  

In the absence of real regulatory reform, readers may ask what they can do to keep their pets safe. 

How to Keep Pets Safe: Use Principles of Ecological Pest Management 

For your pet: While keeping your pets and home free of fleas and ticks is important, Beyond Pesticides recommends talking to your veterinarian about treatment options and asking questions about poisoning incidents associated with any product they recommend. Pet owners should vacuum daily during flea season with a strong vacuum cleaner, changing the bag often; groom pets with a flea comb daily, using soapy water to dunk and clean the comb between strokes; bathe pets frequently with soap and water; and restrict pets to a single bed and wash bedding frequently to kill larvae. If you choose to use a flea and tick product on your pet, have it applied by your veterinarian and monitor pets for any signs of an adverse reaction after application. 

At home: Ecological Pest Management emphasizes the broader ecology of pest management and avoiding toxic chemicals unless there are no alternatives. Use Beyond Pesticides’ ManageSafe page to find out how to take a least-toxic approach to issues in the home and garden! 

Grow Organic Lawns and Gardens!  

Create a pesticide-free space for your pet and encourage neighbors to do the same. There are plenty of resources to help! See Beyond Pesticides’ factsheets for information on how to manage a weed-free yard and lawn: Read Your “Weeds”: A Simple Guide to Creating a Healthy Lawn. Fall is the best time to intervene and make your yard free of toxic chemicals. Read our fall lawncare fact sheet, Organic Lawn Care 101, for specific information on how to prime your yard for next year! An organic lawn requires a holistic paradigm shift, not a product-for-product swap. However, if you’re looking for safe products, look at our Products Compatible with Organic Landscape Management, and our campaign, Parks for a Sustainable Future, for hands-on assistance to municipalities nationwide. 

Advocate for Policy Change 

Ultimately, the burden of keeping our pets safe from toxic chemicals should not fall on the public. Cities, counties, states, and the federal government should respond to the body of evidence showing that toxic pesticides are harmful through precautionary regulation and legislation. See our Tools for Change and contact us at [email protected] if you’re ready to join the movement to end the use of petrochemical pesticides and transition to organic! 
 
All unattributed positions and opinions in this piece are those of Beyond Pesticides. 
 
Sources:  

The EPA Needs to Determine Whether Seresto Pet Collars Pose an Unreasonable Risk to Pet Health, Office of Inspector General, U.S. Environmental Protection Agency, February 29, 2024. 

Report finds EPA failing to do its job amid thousands of Seresto flea and tick collar complaints, New Lede, February 29, 2024. 

To flea or not to flea: survey of UK companion animal ectoparasiticide usage and activities affecting pathways to the environment. PeerJ 11:e15561, Perkins R, Goulson D. 2023. 

Seresto Flea and Tick Collars: Examining Why A Product Linked to More Than 2,500 Pet Deaths Remains On The Market, U.S. House Committee on Oversight and Reform, Subcommittee Economic and Consumer Policy, June 2022.  

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2 Responses to “Inspector General Finds Widely Used Flea Collars Still Not Fully Evaluated by EPA ”

  1. 1
    Toni Noll Says:

    Inspect and fully evaluate flea collars!

  2. 2
    Paula Morgan Says:

    We must have all flea collars evaluated to be sure they are safe! Pets sleep with their daily members and the flea collar has been shown to do greave harm when that is done. Harm to humans and their companion animals. If any flea collar its dangerous we need to get our money back and return to flea collar.

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