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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
 

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