EPA Evaluation of Pet Spot-on Products: Analysis and Plans for Reducing Harmful Effects

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EPA formed an expert veterinarian team to thoroughly analyze the data. In addition, the Agency partnered with the Food and Drug Administration's (FDA) Center for Veterinary Medicine and Health Canada's Pest Management Regulatory Agency, our counterpart agency in Canada, on the review of this analysis. The team

  • studied incidents involving cats and dogs,
  • looked at both active and inert ingredients,
  • studied product labeling, and
  • discussed data needs for the future to improve analyses and regulation.

EPA’s 2010 Data Evaluation Records (DERs) covered products that represented the largest market share of the pet spot-on products at that time. The DERs better characterized incidents received in aggregate incident summaries submitted by the manufacturers to the Agency under FIFRA Section 6(a)(2). The DERs are available online.Search EPA Archive

The results of the analysis are available in the New Restrictions on Flea and Tick Products; Use Products with Extra Care. The Review of Enhanced Reporting of 2008 Pet Spot-on Incidents (EPA-HQ-OPP-2010-0229-0023) has the findings by the agency’s expert team of veterinarians that studied incidents involving cats and dogs, looked at both active and inert ingredients, studied product labeling, and discussed data needs for the future to improve analyses and regulation.

Summary of findings

  • EPA found that the products could be used safely but that some additional restrictions are needed. EPA's team of veterinarians learned that most incidents were minor, but unfortunately some pet deaths and "major incidents" have occurred. The Agency learned that the most commonly affected organ systems were skin, gastrointestinal (digestive), and nervous.

    For more information, refer to Review of Enhanced Reporting of 2008 Pet Spot-on Incidents (EPA-HQ-OPP-2010-0229-0023)

    • Dog Findings: EPA's expert veterinarian team found that
      • small breed dogs were affected more than larger breeds for some products
      • the amount of product in a single dose needed to vary more for small to large dogs; that is, how much the dog weighs matters a lot in deciding how much of a product should be used.
    • Cat Findings: EPA's expert veterinarian team discovered that
      • misuse or accidental exposure of cats to dog products was an important problem; cats can be harmed by dog products because they are more sensitive to certain pesticides; and
      • label warnings against use of dog products on other animals, especially cats, are not working well enough, which appears to be a global concern.
    • Safety Testing: The team also found that the data we now require to determine the safety of these products for pets do not accurately predict the toxicity seen in the incidents that took place.

Changes Based on Evaluation of Pet Incidents

Based on the analysis, we determined that some changes need to be made in how

  • EPA regulates the spot-on products,
  • Companies report data on pet incidents, and
  • Packages are labeled for cats, dogs, and size of animals to prevent unreasonable adverse effects and ensure the safety of these products.

The reported incidents demonstrated that most but not all pet incidents took place because the products were misused, identifying the need for clearer labeling.

Recommendations to reduce harmful effects included:

Further Restrictions on Products

  • Dosing. To address concerns about dosing, EPA requires label and/or packaging changes that would result in more narrow pet weight ranges per vial size. This means 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.
  • Clear labeling to avoid confusion between dog and cat products. To avoid cats being exposed to dog products, EPA is pursuing the following action:
    • 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 understandable. For label clarity, products should have large fonts and pictograms.
  • Make other label changes as needed. EPA meets 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 is pursuing the following actions:
    • No longer allows the interchangeable use of inert ingredients in these formulations;
    • Determines 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.
  • Conditions of Registration As with any registration action, EPA reviews each application on a case-by-case basis to determine whether these conditions are appropriate and applicable to the product in question. The Agency is imposing expects conditions of registration when granting amendments to existing products or granting new registrations. The expected conditions are as follows: o Only one, basic confidential statement of formula :
    • Only one, basic confidential statement of formula
    • The submission of quarterly incident reports and an analysis of these report
    • The submission of quarterly sales information by doses sold

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 us information to act.
  • Grant conditional registrations for new products.
  • Future pet spot-on registrations and amendments to new registrations will be restricted by appropriate conditions to allow us to continue to ensure the safety of these products after they are available to the public.

For more information, see mitigation plan and slides (EPA-HQ-OPP-2010-0229-0024).

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Last updated on June 11, 2024