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fipronil
NYS DEC Letter - Denial of Major Change in Label Registration 2/97


New York State Department of Environmental Conservation
Division of Solid & Hazardous Materials
50 Wolf Road, Albany, New York 12233-7250
Phone 518-457-6934 FAX 518-457-0629

February 7, 1997

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

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 of 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.

Sincerely,

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.