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Denial of Registration of a Major Change in Label for Fipronil

New York State Department of Environmental Conservation
Division of Solid & Hazardous Materials
50 Wolf Road, Albany, New York 12233-7257
Phone 518-57-6934     FAX 518-485-0629

Kandy Walker Duke, Ph.D.
Director, Regulatory Affairs
Rhone Merieux, Incorporated
115 Transtech Drive
Athens, GA 30601

Dear Dr. Duke:

Re:  Denial of Registration of a Major Change in Labeling for Frontline Spray  Treatment (EPA Reg. No. 65331-1)

We have reviewed the application and supporting data submitted by Rhone Merieux to register the referenced pesticide product in New York State. We have concluded, based on the information provided, that use of the product as proposed would likely pose unreasonable risks to human health.

Frontline Spray Treatment contains fipronil as the active ingredient and is labeled to control fleas and ticks on dogs, puppies, cats and kittens.

We previously reviewed this product for registration in New York State, along with the related fipronil-containing products Frontline Top Spot for Cats (EPA Reg. No. 65331-2) and Frontline Top Spot for Dogs (EPA Reg. No. 65331-3). Based on our assessment, the two Top Spot products were determined not to pose significant exposure risks to workers; both were registered on November 6, 1996 for use in New York State.

The Spray Treatment product, however, was determined to pose a greater exposure potential to workers. Registration for the Spray Treatment product was denied due exposure concerns (see correspondence from N. Nosenchuck to K. Walker Duke, dated November 6, 1996).

The November 6, 1996 letter conveyed to Rhone Merieux our concerns about chronic risks to commercial pet groomers who are exposed to the Spray Treatment product. According to our estimate, if a groomer routinely inhales or dermally absorbs even less that one percent of the fipronil estimated to be applied each day, exposures would exceed that which caused neurological effects in a chronic rat study. The United States Environmental Protection Agency (USEPA) indicated concern about chronic risks to commercial pet groomers and conditionally registered the Frontline products for a period of  two years (due to expire on June 1, 1998). Rhone Merieux is required to submit to the USEPA information on inhalation and dermal exposure of workers as well as information on product use.

The decision to deny the registration of Frontline Spray Treatment in New York State was based on the significant exposure potential of fipronil to commercial pet groomers and the toxicological properties of fipronil.

The November 6, 1996 letter also stated the terms under which we would consider another application to register Frontline Spray Treatment in New York State. Rhone Merieux was required to submit a new application and application fee, and either the information on product use and worker exposure required by the United States Environmental Protection Agency to complete the conditions under federal registration or any other additional information which would lessen our concerns for chronic risks to commercial pet groomers.

We received a new application and supporting data from Rhone Merieux on December 10, 1996. The application and supporting data have been reviewed by the New York State Department of Health.

The submitted data consisted of two USEPA exposure assessments for the Spray Treatment product - one for a single application and one for multiple applications in a single day. These assessments were not included in prior application packages. In the latter review, the USEPA states "...the estimates in this review, while based on 20 treatments, represents only one day's exposure. Veterinarians and pet groomers may apply these products for multiple days per week over periods of months. A groomer may treat 20 large dogs per day, 260 days per year." These exposure assessments predate the federal conditional registration of the Frontline products. The fact that the USEPA required additional data on exposure and use suggests that the USEPA did not feel that the data were adequate to evaluate fully the exposure and risks posed by these products.

It is our conclusion that the submitted exposure assessments have not alleviated our concerns for chronic exposure and risks to commercial pet groomers. Therefore, the registration of Frontline Spray Treatment in New York State is denied.

If you reapply for registration of this product in New York State, additional information is required. In the absence of data which specifically addresses chronic risks, the exposure and use study data required as a condition of federal registration, and the USEPA reviews of these studies, would be most relevant for supporting registration of the referenced product in New York State. It is in your interest to make sure that the data submitted to support future applications address the concerns raised in this and previous correspondences regarding this product.

If you have any questions or comments regarding the above, please contact Frank Hegener of our Pesticide Product Registration Section at (518) 457-7446.

Norman H. Nosenchuck, P.E.
Director
Division of Solid & Hazardous Materials

cc:  W. Smith, Cornell University; N. Kim/T. Grey, NYS Dept. of Health; J. Huntley, NYS Dept. of Agriculture & Mkts.

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