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EPA Increases Restrictions on Flea Products

March 18, 2010

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.

Some of the recommendations include:

  • Dosing. To address concerns about dosing, the Agency is pursuing requiring label and/or packaging changes that would result in more narrow pet weight ranges per vial size. This means there will be more categories for the weights of pets so that small, medium, and large dogs get the right amount of product. Pet owners should always be aware of the weight of their pet and purchase and use the correct product for their pet’s weight.

  • Improve labeling to avoid confusion between dog and cat products. Because there were problems reported with cats exposed to dog products, the Agency needs to address this problem and is pursuing the following actions:
    • Label changes that prohibit the use of the same brand names on cat and dog products; and
    • Requiring appropriate, clear label statements to address concerns with cat exposure to dog products as a result of direct application or interactions between cats and dogs in multi-pet households after the application of dog products.
  • Make labels more understandable. To improve label clarity, EPA will pursue changes such as larger fonts and pictograms.
  • Make other label changes as needed. EPA will meet with companies individually to review their products and discuss additional changes to labels or ingredients that the Agency feels are needed. These actions may include anything from adding a more complete list of potential side effects to product labels to canceling products.
  • Inert Ingredients. To address uncertainties about the “inert” (non-active) ingredients in these products and how they might contribute to toxicity, EPA will be pursuing the following actions:
    • No longer allow the interchangeable use of inert ingredients in these formulations;
    • Determine whether additional information is needed and, if so, require that information to evaluate certain inert ingredients; and
    • Disallow inerts that have suspected toxic effects when and if these are identified.

Tighter Regulation

  • Standardized reporting. To be able to monitor these products better, EPA is pursuing more standardized reporting on adverse effects and sales. This will allow the Agency to more effectively review incidents, and if concerns are raised, give EPA information to act.
  • Pre-market clinical trials and post-market surveillance. The Agency is taking steps to bring data requirements in line with FDA’s requirements for similar products. This will allow EPA to be more consistent with how FDA regulates similar animal drugs, which includes pre-market clinical trials and a formal post-market surveillance program, and will allow the Agency to more thoroughly assess the safety of the products.
  • Grant conditional registrations for new products. Future pet spot-on registrations and amendments to new registrations will be restricted by appropriate conditions and time-limitations to allow EPA to continue to ensure the safety of these products after they are available to the public.

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 at: http://www.epa.gov/pesticides/health/petproductseval.html

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

More information on pet products and safety tips: http://www.epa.gov/pesticides/health/pets.htm

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