Yves here. We are running this post as a two-fer: a public service announcement of sorts, as well as a vignette of regulatory corruption. The post below discusses Seresto tick collars, which have been the subject of not mere thousands but over 100,000 FDA incident reports, including over 3,000 pet deaths. Recall that the Chinese melamine pet food scandal started with reports from what Wikipedia calls veterinary organization of a mere 100 deaths, although admittedly Canadian importer Menu Foods confirmed the toxicity in test animals and issued a recall. Here, the FDA looks unwilling to take on Seresto, even with the Office of the Inspector General finding the FDA review to be deficient and directing the agency to perform a new, more rigorous examination.
This smells of the FDA trying to protect a producer rather than consumers and users. This sort of behavior is pervasive in bank regulation, where too often the authorities bend over backwards to protect banks rather than make them shape up. And too often that extends to coddling incompetent and/or corrupt bank executives.
But banks really are essential to the economy, like it or not. One bank failing or being put down by regulators, even if entirely warranted, can set off runs in similar-looking banks even if they are in better condition. And regulators want banks to be profitable so they can put enough aside for loss reserves and increases in capital.
So bank regulators have conflicting priorities and lack good theories and guidelines as to what “adequately profitable” might amount to, which also makes them easy marks for industry blather like, “If we aren’t making pretty good dough, we can’t pay enough to keep that oh so important ‘talent” paid well enough to stick around.”
In other words, bank regulators at least have a colorable excuse for their intellectual capture. The FDA has none. So what is going on here?
By Johnathan Hettinger. Originally published at The New Lede
The Environmental Protection Agency (EPA) has not properly reviewed the safety of a popular flea and tick collar that has been linked to more than 3,000 pet deaths, according to the agency’s top watchdog.
The EPA’s Office of Inspector General (OIG), an independent office in the agency tasked with holding the agency accountable, published a report on Thursday calling on the EPA to make a proper, science-based decision on the Seresto product and improve its processes for making safety determinations for pet products..
The report found that the agency has not conducted or published animal risk assessments as it promised to do, and continues to rely on an inadequate 1998 companion animal safety study.
Seresto pet collars work by releasing two active ingredients, the pesticides flumethrin and imidacloprid. The OIG found that the EPA has failed to properly review those active ingredients, including in a new analysis last year.
Pet Deaths
At a Congressional hearing in June 2022, pet owner Faye Hemsley, of Pennsylvania reported that her dog, Tigger, began to suffer from neurological issues, including his head drooping and a loss of energy, before dying five days after she first put the Seresto collar on him.
Thomas Maiorino, of New Jersey, also testified at the hearing that his family’s dog, Rooney, suffered neurological issues and eventually a seizure, after wearing Seresto. They eventually decided to put the dog down. Many other pet owners reported neurological issues in their animals, including seizures, as well as pet deaths.
The 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. From 2012 through 2022, the EPA received more than 100,000 incident reports related to the collars, including more than 2,500 pet death reports and nearly 900 reports of human pesticide incidents related to the Seresto pet collars.
“The EPA’s response to reported pesticide incidents involving Seresto pet collars has not provided assurance that the collars can still be used without posing unreasonable adverse effects to the environment, including to pets,” the OIG report states.
The collar has been under sharp scrutiny in recent years, after USA Today and Investigate Midwest published an investigation spotlighting the high number of incident reports about Seresto. The US 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 and subsequently determined that the EPA knew for years that Seresto was linked to a high number of pet deaths but took no action and recommending that the EPA take it off market.
The OIG report recommends that the EPA issue a new decision on the chemicals, but the agency disagrees. In a response to the OIG, Michal Freedhoff, the EPA’s assistant administrator for the Office of Chemical Safety and Pollution Prevention, wrote that its 2023 investigation satisfied requirements under the Federal Insecticide, Fungicide and Rodenticide Act, which is the law regulating pesticides.
Freedhoff said there was a lack of evidence to tie the pesticides in the collars to the pet deaths.
“In many of the death-related incidents, critical details of the incident were often missing, preventing the Agency from determining the cause of the death,” Freedhoff’s response states.
“The only reported deaths that were found to be ‘probably’ or ‘definitely’ related to Seresto product use were associated with mechanical strangulation or trauma caused by the collar, often associated with a failure of the release mechanism. In addition, the rate of deaths reported for Seresto was similar to that for other pet products reviewed.”
But the OIG found that the EPA’s July 2023 investigation was fundamentally flawed and said the agency needs to improve assessments of adverse effects to pet health and update inadequate animal safety guidelines to align with international standards.
Lacking Regulatory Rigor EPA proposed transferring all regulation of pet products to the Food and Drug Administration.
The OIG also recommended the EPA implement standard operating procedures for how to conduct domestic risk assessments, measurable standards to determine when a product poses unreasonable adverse effects. The OIG also recommended EPA implement better data requirements both pre-approval and for incident reporting.
“EPA product registration signals to the public that this product has undergone rigorous scrutiny and is deemed safe for public use,” EPA Inspector General Sean W. O’Donnell said in a press release. “Registration reviews must be conducted at the highest standard to safeguard public trust and protect human health, pet health, and the environment.”
