EPA moves forward with transfer of pet product regulation to FDA


JOHNATHAN HETTINGER, Missouri Independent

This story was originally published by Investigate Midwest.

The US Environmental Protection Agency wants to drop its oversight of pesticide products for pets following criticism for its manipulation of a popular flea and tick collar linked to more than 100,000 reports of animal injuries and deaths.

Its offer to hand over the job to the Food and Drug Administration ends a tumultuous period for the EPA sparked by a March 2021 Investigate Midwest/USA TODAY investigation that showed the collar was the subject of more reports of incidents than any other product in EPA history.

For years, EPA scientists have questioned the agency’s ability to regulate pet products because of the way it has handled complaints about Seresto since it first came on the market in 2012. according to Investigate Midwest/USA Today reports. The EPA said Seresto is a “key component,” but not the sole reason for the proposal.

Moving the regulations to the FDA is a “potential long-term solution,” Jake Li, EPA’s deputy assistant administrator for pesticide programs, said in an interview with Investigate Midwest.

“We can’t play this mole game where every time a Seresto-like incident happens we have to divert our staff to it,” Li said.

The EPA has been conducting a formal review of Seresto for nearly two years and expects to finalize the updated science assessment in the coming months, Li said, adding that the FDA assisted with the assessment, both by lending staff and a cadre to assess the position. – market incident data.

The work on Seresto illustrated the flaws in the EPA process, Li said.

“In our ongoing review of the Seresto incidents, what has really become clear to us is that, compared to the FDA, we at the EPA have far fewer resources, which means personnel, expertise, infrastructure and funding, to assess animal safety and conduct ongoing monitoring of products in the market,” Li said.

Li said the EPA’s pesticide office only had two veterinarians on staff, and both had been taken off their regular duties to work on a review of Seresto “almost full-time,” which slowed down their other jobs.

Seresto’s review “has wasted so much time on people who aren’t assigned to any of this work that we think there must be a much better long-term solution,” Li said.

The agencies said in a joint white paper that the FDA would need “significant new resources” to support management of the 600 topical products currently regulated by the EPA; however, the agencies said that building a program comparable to the EPA would also require even more resources and be redundant with the FDA system.

FDA spokeswoman Veronika Pfaeffle said in an emailed statement that the current setup does not allow for scientific progress.

“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.

“The FDA should be the one stop shop”

In the current setup, the EPA is responsible for regulating pet pesticide products that are “non-systemic” or not intended to enter the bloodstream, while the FDA regulates “systemic” pesticide products. for pets, which are generally consumed by pets.

However, the agencies said in the recent white paper that scientists now understand that many topical flea and tick treatments, including spot treatments and collars, actually enter a pet’s bloodstream, which raises questions about the EPA’s product approval process.

“Both agencies agree that the FDA should be the one-stop shop for veterinary drugs, for these external parasite treatments, etc.,” Li said.

The EPA and FDA are hosting a joint virtual public meeting, titled “Modernizing the EPA and FDA’s Approach to Oversight of Certain Products,” on March 22 at noon Central Time 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.

“Getting things done is a good thing, but it will take years. This is the start of a very, very long process,” said Nathan Donley, director of environmental health sciences at the Center for Biological Diversity, which called for Seresto to be banned.

Donley expressed concern that the EPA is allowing the damage to continue by not taking action on products like Seresto.

“He’s not letting the EPA off the hook,” Donley said. “They have to do things now that are under their authority.”

Seresto is just one product related to major concerns about animal 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 also raised concerns in internal documents about pet products containing fipronil, a chemical used in the popular Frontline Plus spot treatment, which has been the subject of more than 5 000 human health incident reports, according to a review of the incident by Investigate Midwest. data.


Exam in preparation for “years”

EPA staff sounded the alarm about Seresto’s safety as early as 2015. But the agency didn’t launch a formal review until after the nonprofit Center for Biological Diversity filed a petition asking the agency to cancel Seresto, following reports from Investigate Midwest and USA TODAY.

Last summer, a congressional subcommittee asked the EPA to revoke Seresto’s registration, noting that Canada had rejected the collar based on the EPA’s own incident data – and the The EPA has found an even stronger link between a pet’s death and the collar than Canadian regulators.

For years, the EPA and officials from Bayer and Elanco, which bought Bayer’s animal health division — including Seresto — in 2020, met to discuss the agency’s issues with the product. In these 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 – were not responsible for any pet deaths.

EPA scientists have made 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. These scientists often emailed this information, until a superior told two scientists not to email their concerns, according to documents.

Yet the EPA has failed to make the public aware of the risks. The EPA inspector general has launched a review of the agency’s handling of incident reports associated with the product.

Li said the proposal to transfer the regulation of pesticide products for pets to the FDA had been in the works since before the public outcry over Seresto.

“Seresto is a key part of that, but it’s not the only one,” Li said. “It predates Seresto by three to four years. It’s really driven by the discussion between our career staff and the FDA career staff.

In a March 2021 presentation made in response to the Investigate Midwest/USA TODAY story on Seresto, EPA staff pointed out that compared to the FDA, the agency’s process is lacking. The presentation noted that the EPA process relies on company-funded studies that use less susceptible pet breeds and small sample sizes. In comparison, the FDA has a much more comprehensive pet product regulatory process, which includes premarket clinical trials and postmarket surveillance.

The EPA also has no process for evaluating pet incident reports or triggering when the number of incidents requires further review.

Documents show that EPA officials informed Ed Messina, director of the Office of Pesticide Programs, which oversees all pesticides, of the FDA/EPA issues in March 2021, shortly after the article was published. Investigate Midwest/USA TODAY.

In response, Messina attempted to contact the FDA, but FDA staff members refused to give Messina the email of Dr. Steven Solomon, director of the FDA’s Center for Veterinary Medicine.

“The FDA counterparts don’t seem to want to give us his contact information. We don’t know what to do, it’s a very strange situation,” wrote EPA employee Meredith Laws.

Congressional action needed to move forward

The proposal takes “two separate but parallel tracks” — one for public input and one for Congressional information, Li said.

“Ultimately Congress is the one who will decide if and how to move things forward,” Li said. “We can only describe the challenges and what we are looking for in terms of solutions.”

Li said the agencies were still briefing congressional committees on the proposal and had not yet finished.

Pfaeffle, the FDA spokeswoman, said in her emailed statement that the agencies were working with Congress on potential solutions.

“We are asking for Congress’ help in working toward a modernized approach to product oversight that increases government transparency and efficiency, aligns with each agency’s expertise, and provides regulatory certainty – to stakeholders, including pet owners, industry, veterinarians and others,” the statement said.

Li said the agencies have already met with industry and environmental groups for comment.

“We’re in the very early stages of socializing this proposal,” Li said. to see what people say.”

Investigate Midwest is an independent, not-for-profit newsroom. Its mission is to serve the public interest by exposing the dangerous and costly practices of influential agricultural corporations and institutions through in-depth, data-driven investigative journalism. Visit online at

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