EPA imposes new regulations on spot-on flea and tick pesticides, calls for comments

The Environmental Protection Agency announced March 17 it is tightening regulations on dog and cat spot-on pesticides after an increase in adverse reaction reports in 2008 prompted a government investigation of the products' safety.

The government saw no cause to ban or recall any of the flea and tick control products marketed in the United States but did see an immediate need to determine which spot-on products require stronger labeling statements to prevent misuse. Specifically, the EPA wants manufacturers to list on the label and package more precise pet weight ranges for the various vial sizes and to be clearer about whether products are intended for use in cats or dogs.

The agency said it is also developing more stringent testing and evaluation requirements for both existing and new 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."

In 2009, the EPA and Health Canada Pest Management Regulatory Agency became increasingly concerned about the large number of incident reports involving spot-on flea and tick products. Incidents ranged from skin irritation to death, and several class-action lawsuits have been filed against the products makers.

The U.S. and Canadian agencies evaluated incident data from 2007 and 2008. It's that analysis on which the EPA is basing its conclusions. In its report, the EPA found most adverse incidents involving dogs occurred in animals less than 3 years old and weighing 10 to 20 pounds. Most incidents involving cats occurred in animals weighing 5 to 15 pounds. Notably, many cat incidents resulted from use of a spot-on product meant for heavier cats or for dogs.

The agency stated a comparison of the absolute numbers of incidents among the various spot-on products was not appropriate for a number of reasons, including the fact that some products may have had higher numbers of reported adverse incidents because more of the product was sold. In addition, pet owners voluntarily report incidents, which may have causes other than pesticide exposure.

Other immediate actions the EPA will pursue are requiring additional changes for specific products, as needed, based on product-specific evaluations; granting only conditional, time-limited registrations to allow for post-marketing product surveillance when new products are registered; restricting the use of certain inert ingredients the EPA finds may contribute to the adverse incidents; and launching a consumer information campaign to explain new label directions and to help users avoid making medication errors.

To improve the regulatory oversight of pet products, the 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 in line with the Food and Drug Administration's requirements.

The EPA is inviting public comment on how best to implement these new measures. A Federal Register notice announcement was published March 18, and comments will be accepted through May 17. The docket number is EPA-HQ-OPP-2010-0229; comments can be submitted at www.regulations.gov.

The agency is coordinating its actions with Health Canada, which identified similar concerns about the use of spot-on flea and tick products last year, and with the FDA's Center for Veterinary Medicine. The EPA's report on the evaluation of products and incidents is available at epa.gov/pesticides/health/petproductseval.html.

The EPA recommends veterinarians use the National Pesticide Information Center's Veterinary Pesticide Adverse Effects Portal at http://npic.orst.edu/vet to report incidents.