PMEP Home Page --> Pesticide Active Ingredient Information --> Insecticides and Miticides --> fenitrothion (Sumithion) to methyl parathion --> fipronil --> fipronil NYS DEC Letter - Registration of Major Change in Label 7/99

fipronil
NYS DEC Letter - Registration of Major Change in Label 7/99


New York State Department of Environmental Conservation
Division of Solid and Hazardous Materials, Room 488
50 Wolf Road, Albany, New York 12233-7250
Phone: (518) 457-6934 FAX: (518) 457-0629

July 19, 1999

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

Ms. Linda Byers
State Registration Specialist
Maxforce Insect Control System
c/o The Clorox Company
P.O. Box 493
Pleasanton, CA 94566-0803

Dear Ms. Byers:

Re: Registration of One New Pesticide Product, Maxforce FC Professional Insect Control
    Roach Killer Bait Gel (EPA Reg. No. 64248-14), Which Represents a Major Change in Labeling
    for the Active Ingredient Fipronil

The Department has completed the review of your application, received October 21, 1998, and
additional information, received December 29, 1998, March 2, 1999 and March 23, 1999, to
register the above-mentioned product in New York State. The application was deemed complete
on April 5, 1999 and a registration decision is due by September 2, 1999.

Fipronil is currently registered in New York State for use in products labeled for flea and
tick control on dogs, puppies, cats and kittens and as an indoor/outdoor bait station for
insect control. The proposed use of Maxforce FC Professional Insect Control Roach Killer
Bait Gel as a spot or crack and crevice treatment in and around structures represents a
major new use pattern for the active ingredient fipronil in New York State.

The Department has reviewed the information supplied to date in support of the major change
in labeling application for Maxforce FC Professional Insect Control Roach Killer Bait Gel
(EPA Reg. No. 64248-14).

The acute toxicity data used to support the registration of Maxforce FC Professional Insect
Control Roach Killer Bait Gel indicate that it is not very toxic to laboratory animals on an
acute basis by the oral or dermal routes of exposure. The acute inhalation study was not
required for federal registration due to the low potential for inhalation exposure. The data
also indicates that the product was not very irritating to skin or eyes and was not a
sensitizer.

The Maxforce label directs the applicator to place up to four spots of gel, each weighing
0.25 to 0.5 grams, for every square yard of treatment area. The product is labeled for
crack and crevice use and it is unlikely that children would access the bait gel once it
is applied. However, the registrant conducted a study to ev	ate the potential ingestion of
the Maxforce product if a child were to have free access to the syringe used to apply the
gel bait. For the tests, the syringes were filled with cheese (not the Maxforce gel) and
contained the same concentration of a bittering agent that Maxforce contains. The 68
children in the study ranged in age from 42 to 51 months. In this study, the average amount
of cheese eaten by the children was 0.376 grams (the range of ingestion was not mentioned).
Based on this exposure estimate, the United States Environmental Protection Agency (USEPA)
calculated a 150-fold margin-of-exposure (MOE) when compared to a no-observed-effect level
(NOEL) for clinical effects from an acute neurotoxicity study in rats (0.5 milligrams per
kilogram body weight per day (mg/kg/day)). Because this product is labeled for professional
use, it is unlikely that children will have access to the syringes used to apply the gel.

The USEPA also estimated risks for Maxforce applicators based on information from the
registrant and the Pesticide Handlers Exposure Database. It was assumed that applicators
handle 1,000 grams of the product over the course of a year and that they have skin contact
with one percent of this material. The exposure estimates were compared to a NOEL of 5
mg/kg/day for decreased body weights and food consumption from a repeat dose dermal study
in rats. The long-term MOE for dermal exposure of applicators is estimated to be 880. The
short-term and intermediate-term MOE for dermal exposure of applicators is estimated to be
5,000.

The acute toxicity data used to support the registration of the Maxforce product indicate
that it would not be very toxic. While fipronil caused a number of toxicological effects
in studies on laboratory animals, exposure estimates for children with accidental ingestion
of the gel and workers with incidental contact with the product during application, indicate
that adequate margins of exposure exist. Furthermore, fipronil has a low volatility
(2.8 x 10-9 mm Hg at 20 degrees Celsius) and is used in small quantities and, therefore,
should not impact indoor air.

Therefore, the Department hereby accepts for registration Maxforce FC Professional Insect
Control Roach Killer Bait Gel (EPA Reg. No. 64248-14).

Enclosed are your New York State Certificate of Pesticide Registration and your New York
State stamped "ACCEPTED" label.

If you have any questions, please contact Maureen P. Serafini, Chief of our Pesticide
Product Registration Section, at (518) 457-7446.

Sincerely,

Stephen Hammond, P.E.
Director
Division of Solid & Hazardous Materials
Enclosures

cc: w/enc. - N. Kim/D. Luttinger - NYS Dept. of Health
             E. Biel/ R. Mungari - NYS Dept. of Ag. & Markets
             G. Good/W. Smith - Cornell University, PMEP