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Pyriproxyfen - Registration of a Major Change of Label for Distance® 6/00

New York State Department of Environmental Conservation
Division of Solid & Hazardous Materials
Bureau of Pesticides Management, Room 498
Pesticide Product Registration Section

50 Wolf Road, Albany, New York 12233-7254
Phone: (518) 457-0300FAX: (518) 485-8836
Website: www.dec.state.ny.us/website/dshm/pesticid/pesticid.htm


June 29, 2000

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

Mr. Harry Radke
State Registration Project Manager
Valent U.S.A. Corporation
1333 North California Blvd., Suite 600
P.O. Box 8025
Walnut Creek, CA 94596-8025

Dear Mr. Radke:

Re: Registration of a Major Change in Labeled Use Pattern for the Active Ingredient Pyriproxyfen Contained in the Pesticide Product Distance® Insect Growth Regulator (EPA Reg. No. 59639-96)

    The New York State Department of Environmental Conservation ("The Department") has completed review of your application and supplemental information supplied to date regarding registration of an outdoor ornamental use pattern for the referenced pesticide product in New York State. The subject application and data package were deemed complete for purposes of technical review on February 2, 2000. Pursuant to the review timeframe specified in Environmental Conservation Law (ECL) §33-0704.2, a registration decision date of July 1, 2000 was established.

    Distance® Insect Growth Regulator (EPA Reg. No. 59639-96) contains 11.23% pyriproxyfen (2-[1-methyl-2-(4-phenoxyphenoxy)ethoxy]pyridine) and is labeled for control of insects including whiteflies, scales, shore flies, and fungus gnats in indoor (greenhouse, lath and shadehouse, and interiorscapes) and outdoor ornamentals, including flowering and foliage crops, ground covers, shrubs and ornamental trees, and in non-bearing fruit and nut trees. The maximum application rate for Distance® (four applications per year @ 12 fluid ounces per 20,000 square feet) is equivalent to 0.70 pounds pyriproxyfen/acre/year.

    Previously registered use patterns for the active ingredient pyriproxyfen include products for indoor non-food/feed, indoor residential, domestic animal, indoor (greenhouse, lath and shadehouse) ornamental and outdoor perimeter area applications. The outdoor ornamental use pattern represents a major change in labeled (MCL) use pattern for pyriproxyfen in New York State.

    The Department conducted toxicological and environmental fate risk assessments for pyriproxyfen and the Distance® formulation. An ecological effects risk assessment was not available at this time.

TOXICOLOGICAL RISK ASSESSMENT:

    Neither the formulated product nor the active ingredient was very toxic on an acute basis to laboratory animals by the oral, dermal or inhalation routes of exposure. Whereas, the formulated product was moderately irritating to rabbit skin and mildly to moderately irritating to their eyes, the active ingredient was not very irritating to animal eyes or skin. Neither the formulated product nor the active ingredient caused dermal sensitization (tested in guinea pigs). In addition, the active ingredient pyriproxyfen did not cause oncogenic or reproductive effects and was negative in several genotoxicity studies. Some developmental effects (at maternally toxic doses) were reported in rats, but not in rabbits. The United States Environmental Protection Agency's (USEPA) Office of Pesticide Programs developed a reference dose of 0.35 milligrams per kilogram body weight per day (mg/kg/day) based on a no-observed-effect level (NOEL) of 35 mg/kg/day in a two-year rat feeding study (decreased body weight of female rats at 183 mg/kg/day) and an uncertainty factor of 100.

    No worker risk data are available on the use of the Distance® product. However, neither the product nor pyriproxyfen were very toxic in laboratory studies and the application rates for Distance® are relatively low (39.9 - 79.7 grams pyriproxyfen per acre). In addition, the label requires that applicators wear a considerable amount of personal protective equipment including coveralls over short-sleeved shirt and short pants or long-sleeved shirt and long pants, chemical-resistant gloves, chemical-resistant footwear and socks, and chemical-resistant headgear for overhead spraying. In addition, a chemical-resistant apron is required for those involved in cleaning equipment, mixing or loading the pesticide.

    There are no chemical-specific federal or State drinking water/groundwater standards for pyriproxyfen. Based on its chemical structure, pyriproxyfen falls under the 50 microgram per liter (mg/L) general New York State drinking water standard for an 'unspecified organic contaminant' (10 NYCRR Part 5, Public Water Systems).

ENVIRONMENTAL FATE RISK ASSESSMENT:

    The latest USEPA Environmental Fate and Effects Division review (07/13/99) indicates deficiencies remain in the environmental fate data (aerobic soil metabolism, adsorption/desorption, terrestrial field dissipation studies). Data from these studies are essential for the assessment of the impact of a pesticide product to groundwater/drinking water.

    The Department's groundwater model (LEACHM) was run on Riverhead soil using a Koc of 14,000, an aerobic half-life of nine days and the maximum application rate of 11 ounces pyriproxyfen/acre/year. Degradates were not modeled because there was no information for them presented in the Data Evaluation Records (DERs). The model projected no pyriproxyfen in the leachate using the questionable input parameters.

    Although certain studies were found to be unacceptable to the USEPA, pyriproxyfen's half-life was very short. Even if this half-life is found to be longer, it will not make a significant difference in the overall leachability of the product. Based on this assumption, together with the low application rate and the high Koc values, Distance®, when used as labeled, should not have an impact on ground or surface water in New York State.

CONCLUSION:

    When used as labeled, the outdoor ornamental use pattern for Distance® should not cause unreasonable adverse effects to humans or the environment.

    The Department hereby accepts the outdoor ornamental use pattern for Distance® Insect Growth Regulator (EPA Reg. No. 59639-96). Enclosed for your files is the New York State stamped-'ACCEPTED' labeling (Supplemental label Form SU18000A0.099204 and integrated labels Form 1330-B and Form 1330-C.

    Please note that a proposal by Valent U.S.A. Corporation or any other registrant to register a product containing pyriproxyfen, whose labeled uses are likely to increase the potential for significant impact to humans, property or the environment, would constitute a major change in labeled (MCL) use pattern. Such an application must be accompanied by a new application fee and meet the requirements listed in Appendix 1.B. of "New York State Pesticide Product Registration Procedures" (August 1996).

    Please contact Frank Hegener, Acting Chief of our Pesticide Product Registration Section, at (518) 457-7446, if you have any questions.

Sincerely,

Maureen Serafini
Director
Bureau of Pesticides Management

Enclosures

cc: w/enc. - N. Kim/D. Luttinger, NYS Dept. of Health
J. Leach/J. Kaplan, NYS Dept. of Health
R. Zimmerman/R. Mungari, NYS Dept. of Ag. & Markets
G. Good/W. Smith, Cornell PMEP

bcc: w/enc. - T. Martin, DFW&MR
SPCS I, Reg. 1
PCS II's, Regions 2-7 &9
D. Rollins, Region 8
M. Radzevich (2)
Valent U.S.A. Corporation File
Chemical File
Active File

bcc: w/o enc. - M. Serafini
T. Lynch
L. Whitbeck
F. Hegener
B. Seeley
PPRS Daybook

MJR:scy
(mike\dista1sh.val)