Seresto Could Get FDA Oversight, But Some Say That Won't Make It Safer

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Amid rising concerns over potentially deadly flea-and-tick collars, the Environmental Protection Agency’s plan to transfer regulation of such products to another agency drew skepticism from animal and environmental advocates at a virtual public meeting on Wednesday.

The proposal and meeting came two years after a USA TODAY/Investigate Midwest story revealed the EPA sat on tens of thousands of adverse incident reports linked to the best-selling flea-and-tick collar: Seresto.

The media organizations’ reporting sparked congressional action and public outcry over the agency’s regulation of the collars, which have since racked up more than 100,000 reports of harm to pets and people, including 2,698 pet deaths.

The EPA, whose officials said they lack the staffing and resources to adequately assess and monitor the products’ safety, wants to relinquish oversight of all such pet pesticides to the Food and Drug Administration. The FDA is a co-sponsor of the plan.

“Our agencies understand and share the concerns that many of you have around these products because pets hold a really special place in our hearts,” said Jake Li, EPA’s deputy assistant administrator for pesticide programs.

Advocates said they worry the EPA is trying to shirk its duty to protect people and fear the FDA lacks the ability to assess the products’ environmental hazards.

The proposed transfer in regulation can’t be a substitute for taking action on harmful products, said Lori Ann Burd, environmental health program director for the Center for Biological Diversity, one of dozens of people who spoke at the two-hour hearing.

Burd said she regularly hears from pet owners whose pets have been harmed or died after wearing Seresto collars. Many have attempted to contact EPA and not heard back, she said, adding that the EPA has an obligation to do something to limit Seresto’s harm, not just transfer authority to FDA.

“What’s the point of collecting incident reports if you do nothing with them? How many incidents would warrant action if not 100,000?” Burd said. “You still have a duty to act now, EPA, and I hope you will before many more dogs, cats and people suffer from the consequences of your inaction.”

Eleni Healey, staff veterinarian at the Philadelphia Animal Welfare Society, said she has seen problems with flea and tick treatments firsthand, and the federal government needs to improve safety evaluations – whether that’s the FDA or EPA.

Healey said if regulation of flea and tick products is transferred to FDA, the agency needs to make sure safe products are still available over-the-counter because many pet owners can’t afford to go to veterinarians.

Bill Jordan, a representative of the Environmental Protection Network, which is made up of former EPA staff, expressed concerns that the FDA might not have the regulatory authority to properly assess risks to the environment from pet products.

Chemicals used in topical flea and tick treatments, such as imidacloprid and fipronil, can cause problems for wastewater facilities because the pesticides poison the water, leading to Clean Water Act violations and causing problems with reusing the water, said Cynthia Finley, director of regulatory affairs for the National Association of Clean Water Agencies.

Stephanie Hughes, a chemical engineer and representative of the Bay Area Clean Water Agencies, also noted pesticide pollution can affect compliance with water safety standards.

Hughes added that wastewater agencies have no authority to control indoor or upstream pesticide uses, and so far, the EPA has failed to consider the Clean Water Act and Endangered Species Act when it comes to these pet products.

“You’re legally obligated to protect our waterways,” Hughes said.

Plan would bring regulation ‘into the 21st century’

Top officials from both agencies were present at the meeting but did not specifically address remarks by the speakers. Instead, they gave a short presentation about the proposal that emphasized the need to overhaul the current regulatory system.

Tracey Forfa, who was appointed director for FDA’s Center for Veterinary Medicine last month and has worked for the agency for more than 30 years, said the two agencies split duties using an “outdated 50-year-old approach” laid out in a 1971 Memorandum of Understanding between the two agencies.

Ellen Hart, veterinary medical officer at the FDA, said the government’s understanding of science has evolved and the proposal is designed to bring regulation of pet pesticide products “out of the 1970s and into the 21st century.”

Li said the proposal predates public concerns about Seresto. Last summer, a congressional subcommittee called on the EPA to cancel Seresto, after finding that EPA failed to take action for years despite concerns from its own scientists.

The Center for Biological Diversity also filed a petition asking EPA to cancel Seresto in April 2021. EPA has been working on its response to the petition, including soliciting help from FDA staff, and expects to release a scientific analysis and response in the coming months, Li said earlier this month.

Michael Goodis, deputy director for programs for EPA’s Office of Pesticide Programs, outlined in the meeting how the Seresto review revealed the flaws in the EPA system for regulating pet products.

“In doing this work, one thing has become really clear, and that’s that EPA lacks staff with the dedicated expertise to adequately regulate these types of products including pet collars and spot-on treatments, which currently fall under EPA’s oversight,” he said.

Goodis said FDA has more veterinarians on staff, a post-market surveillance system and strategies for evaluating incident reports, and thus, is better at evaluating and monitoring the safety of pet products. Agency officials believe it makes more sense for FDA to take over regulation of these products, he said, rather than for EPA to build up its staff.

“We are striving for good government that is efficient and transparent, and it really doesn’t make sense for EPA to build our own CVM or Center for Veterinary Medicine,” Goodis said.

Whatever happens, the two agencies need to “move cautiously” and provide more information about how the shift would occur to help inform public comments, said Mary Jane McNamee, director of scientific and regulatory affairs at the Animal Health Institute, a national trade organization for animal medicine companies.

“Many questions exist that should be considered prior to such a major change to U.S. regulatory policy,” McNamee said, such as how labeling could change and how currently approved products would be reevaluated.

There also were numerous comments from honey bee producers and researchers about how the current regulation of materials to help protect honey bees from pests aren’t working, resulting in honey bee producers using products that aren’t regulated by the federal government.

Nathan Donley, environmental health science director at the Center for Biological Diversity, said government documents show that EPA has consistently given deference to company officials and representatives over its own scientists. Investigate Midwest and USA TODAY reported on those documents last year, revealing EPA scientists were told to keep their concerns about Seresto off of email.