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lambda-cyhalothrin (Karate, Force) NYS DEC Letter - Pesticide Registration 2/01


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) 457-7446 FAX: (518) 485-8990
Website: www.dec.state.ny.us/website/dshm/pesticid/pesticid.htm
E-Mail:ppr@gw.dec.state.ny.us


February 14, 2001


CERTIFIED MAIL
RETURN RECEIPT REQUESTED

Thomas L. Woods, PhD.
Regulatory Project Manager
Syngenta Crop Protection, Inc.
1800 Concord Pike
P.O. Box 15458
Wilmington, DE 19850-5458

Dear Dr. Woods:

Re: Registration of Scimitar GC Insecticide (EPA Reg. No. 10182-400) containing the active ingredient lambda-cyhalothrin for additional labeled use on ornamentals in commercial greenhouses, shadehouses, and nurseries.

    The New York State Department of Environmental Conservation (the Department) has completed its review of your application received on February 17, 2000 to register Scimitar GC Insecticide (EPA Reg. No. 10182-400) for additional labeled use on ornamentals in commercial greenhouses, shadehouses, and nurseries. The listed additional uses constituted a major change in labeled use(MCL) pattern for the active ingredient lambda-cyhalothrin in New York State. The Department has conducted a technical review of potential risk to mixer/handler/applicators (worker exposure) applying Scimitar GC Insecticide in the commercial greenhouse, shadehouse, nursery environment.

    The Department has accepted for registration, the supplemental labeling "for use to control insect pests on ornamentals grown in commercial greenhouses, shadehouses and nurseries" based on the results of our human health assessment of worker exposure data and acute toxicity data provided by Zeneca Ag Products.

    Scimitar GC was initially registered in New York State on November 13, 1997 for use to control insect pests on golf courses, athletic field turf, sod farms, ornamentals and lawns in landscaped areas around residential, institutional, public, commercial and industrial buildings, parks and recreational areas. Scimitar GC contains 9.7% of the active ingredient lambda-cyhalothrin.

    The product is classified as a restricted use pesticide by the United States Environmental Protection Agency (USEPA) due to toxicity to fish and aquatic organisms. The federal label requires a 25 foot buffer to lakes, reservoirs, rivers, permanent streams, marshes or natural ponds, estuaries and commercial fish farm ponds. The product is also registered as a restricted use pesticide in New York State due to toxicity to fish and aquatic organisms. New York State requires an additional labeled restriction, "In the State of New York, do not apply within 100 feet of coastal marshes or streams that drain into marshes." which is protective of the State’s aquatic resources. The supplemental label for use on ornamentals in commercial greenhouses, shadehouses, and nurseries will also be stamped as a "restricted use" pesticide.

Summary of the Worker Exposure Assessment:

    The Department has previously reviewed the toxicological properties of cyhalothrin in the pesticide products Commodore WP Insecticide and Warrior Insecticide. The USEPA determined that cyhalothrin and lambda-cyhalothrin are sufficiently similar to allow use of the cyhalothrin database to fulfill many lambda-cyhalothrin registration requirements. Listed below are the results of the technical review for mixer/handler/applicator exposure to Scimitar GC Insecticide.

  • On an acute basis, cyhalothrin was moderately toxic by the oral route and mildly to moderately toxic via the dermal and inhalation routes of exposure. This chemical was not very irritating to eyes and skin, but was a mild dermal sensitizer.


  • The USEPA RfD Peer Review Committee derived a reference dose (RfD) of 0.001 mg/kg/day for cyhalothrin/lambda-cyhalothrin, based on a no-observed-effect level (NOEL) of 0.1 mg/kg/day from a one-year dog feeding study and an uncertainty factor of 100.


  • Based on the available carcinogenicity studies in rats and mice, the USEPA classified cyhalothrin as a Group D carcinogen - not classifiable as to human carcinogenicity.


  • For mixer/loader/spray operators, the Applicant estimated an average daily absorbed dose of 0.0011 mg/kg/day. Derived from a study of Pakistani workers applying lambda-cyhalothrin based insecticide over a fifteen-day period for mosquito control.


  • The Applicant stated that a typical daily greenhouse treatment would use about 100 gallons of diluted product which can contain up to about 15.6 grams lambda-cyhalothrin for labeled application of the Scimitar product to ornamental plants.


  • The daily absorbed dose estimate of 0.0011 mg/kg/day (Pakistani Worker Study) was modified for a difference in the daily lambda-cyhalothrin application rate (60 vs. 15.6 grams) and compared to a NOEL from a one-year dog feeding study (0.1 mg/kg/day). A margin of exposure (MOE) of about 350 for the Scimitar SC product was calculated. Generally, MOEs of 100-fold or greater are considered adequate by the USEPA.


  • Inhalation risks should be minimal for the use of the Scimitar GC product based on the vapor pressure of lambda-cyhalothrin (1.6 x 10-9 mm Hg at 20oC.) and overall low volatility of the formulation.


    The Department has determined that the exposure potential for mixers, handlers, and spray operators, using the Scimitar GC product in accordance with the product label should not pose any significant health risks to these applicators. Scimitar GC Insecticide (EPA Reg. No. 10182-400) is labeled as a "restricted use pesticide" for sale to and use only by certified applicators or persons under their direct supervision. In addition, the exposure potential to the general public of lambda-cyhalothrin from the additional labeled use of Scimitar GC Insecticide in commercial greenhouses, shadehouses and nurseries, is not significant.

    Enclosed for your records, is a copy of the stamped "accepted" supplemental label (code: ZPP-SCI-007; dated 2/4/2000) for use of Scimitar GC Insecticide to control insect pests in commercial greenhouses, shadehouses, and nurseries. This supplemental label along with the Scimitar GC Insecticide label accepted for registration on 07/16/99 by the Department are the approved labeling for sale and use of the product to control insect pests in commercial greenhouses, shadehouses, and nurseries in New York State.

    Please note that a proposal by Syngenta Crop Protection, Inc. (formerly Zeneca Ag Products), or any other registrant, to register a product that contains lambda-cyhalothrin and 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). Such information as well as forms can be accessed at our website as listed in our letterhead.

    Please contact Frank Hegener, 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
R. Zimmerman/ R. Mungari - NYS Dept. of Ag. & Markets
G. Good/W. Smith - Cornell University, PMEP