EPA to Increase Restrictions on Spot-On Flea and Tick Products

Due to a significant increase in adverse incidents, the U.S. Environmental Protection Agency is taking a series of actions to increase the safety of spot-on pesticide products for flea and tick control for cats and dogs. Immediately, EPA will begin reviewing labels to determine which ones need stronger and clearer labeling statements. Next, EPA will develop more stringent testing and evaluation requirements for both existing and new products. EPA expects these steps will help prevent adverse reactions. In dogs and cats that can include skin effects, such as irritation, redness, or gastrointestinal problems that include vomiting or diarrhea, or effects to the nervous system, such as trembling, appearing depressed or seizures—from pet spot-on products.

“EPA is committed to better protecting the health and safety of pets and families in all communities across our nation,” said Steve Owens, assistant administrator of EPA’s Office of Prevention, Pesticides and Toxic Substances. “New restrictions will be placed on these products, and pet owners need to carefully read and follow all labeling before exposing your pet to a pesticide.”

Following the 2008 increase in incident reports, EPA received additional information from the pet spot-on pesticide registrants and others and began an intensive evaluation of these products. Today, EPA is reporting the results of this evaluation, and taking steps to address the spike in reported incidents.

Among immediate actions that EPA will pursue are:

  • Requiring manufacturers of spot-on pesticide products to improve labeling, making instructions clearer to prevent product misuse.
  • Requiring more precise label instructions to ensure proper dosage per pet weight.
  • Requiring clear markings to differentiate between dog and cat products, and disallowing similar brand names for dog and cat products. Similar names may have led to misuse.
  • Requiring additional changes for specific products, as needed, based on product-specific evaluations.
  • When new products are registered, granting only conditional, time-limited registrations to allow for post-marketing product surveillance. If there are incidents of concern associated with the product, EPA will take appropriate regulatory action.
  • Restricting the use of certain inert ingredients that EPA finds may contribute to the incidents.
  • Launching a consumer information campaign to explain new label directions and to help users avoid making medication errors.

In addition, to improve the regulatory oversight of pet products, EPA will require more standardized post-market surveillance reporting on adverse effects, require submission of more sales information so the agency can better evaluate incident rates, and bring up-to-date the scientific data requirements on pre- and post-market testing so they are more in line with the Food and Drug Administration’s requirements.

Flea and tick products can be appropriate treatments for protecting pets and public health because fleas and ticks can transmit disease to animals and humans. While most people use the products with no harm to their pets, the agency's analysis determined that smaller dogs tend to be disproportionately affected by some products and that the exposure of cats to some dog products is a concern.

People should carefully follow label directions and monitor their pets for any signs of an adverse reaction after application, particularly when using these products for the first time.

EPA recommends that owners consult a veterinarian about the best way to protect their pets from fleas and ticks or whether pesticides are needed, especially before using any product on weak, aged, medicated, sick, pregnant or nursing pets, or on pets that have previously shown signs of sensitivity to pesticide products.

EPA is coordinating these actions with Health Canada as Canada also identified similar concerns about the use of spot-on flea and tick products last year, and with the Food and Drug Administration’s Center for Veterinary Medicine.

The agency is inviting public comment on how best to implement these new measures. A Federal Register notice announcing the opening of a docket will be published on March 19, 2010. The docket number is EPA-HQ-OPP-2010-0229.

EPA’s report on the evaluation of products and incidents is available.

EPA recommends that veterinarians use the National Pesticide Information Center’s Veterinary Pesticide Adverse Effects Portal to report incidents.

Published: March 17, 2010;    Updated: June 24, 2010

Filed Under: Health Safety, Recalls Warnings

Source: EPA Press Release, March 17, 2010

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