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lambda-cyhalothrin NYS DEC Letter - Incomplete Application to Register 2/02


New York State Department of Environmental Conservation
Division of Solid & Hazardous Materials
Bureau of Pesticides Management
625 Broadway, Albany, New York  12233-7254
Phone 518-402-8788      FAX 518-402-9024
Website: http://www.dec.state.ny.us


February 24, 2003


CERTIFIED MAIL
RETURN RECEIPT REQUESTED


Ms. Kelly Loft
Spectrum Group, Div. of United Industries Corporation 
P.O. Box 142642
St. Louis, Missouri 63114-0642


Dear Ms. Loft:

Re: Registration of a Major Change in Labeled (MCL) Use Pattern for the Active 
       Ingredient Lambda-Cyhalothrin Contained in the Pesticide Product Spectracide 
       Bug Stop Home Insect Killer (EPA Reg. No. 9688-176-8845)


The New York State Department of Environmental Conservation (Department) has completed 
review of the application (received 10/03/02) regarding registration of Spectracide Bug 
Stop Home Insect Killer (EPA Reg. No. 9688-176-8845) in New York State. We have determined 
that use of this product, as labeled, will not pose unreasonable risks to humans or to the 
environmental resources of New York State. Therefore, the Department accepts Spectracide Bug 
Stop Home Insect Killer (EPA Reg. No. 9688-176-8845) for registration in New York State.  


BACKGROUND: Spectracide Bug Stop Home Insect Killer (0.03% lambda-cyhalothrin) is 
labeled as a crack/crevice and surface spray for indoor and outdoor use around homes and 
as a barrier treatment around building foundations and other areas. Product labeling bears 
the statement "For use around the home only." A maximum application rate or re-treatment 
interval is not specified for the crack/crevice  and surface spray use patterns. The barrier 
or perimeter treatment recommends one gallon per 800 sq. ft. which is equivalent to 0.136 
pound lambda-cyhalothrin/acre/application. No re-treatment interval or maximum number of 
annual applications is specified.


Lambda-cyhalothrin is a component of products previously registered in New York State for use 
as an insecticide in cattle ear tags, for residual pest control in and around buildings and 
structures, for control of insect pests on ornamentals and turf, for control of insect pests 
in the commercial greenhouse, shadehouse and nursery environment and as an insecticide on 
various crops. In addition, two products containing lambda-cyhalothrin are currently being 
reviewed as a major change in labeled (MCL) use pattern, i.e., for domestic outdoor use 
(application to lawns) by homeowners. The proposal to register a pesticide product labeled 
for domestic indoor use by homeowners represents a MCL for lambda-cyhalothrin.


The subject registration package was deemed complete for purposes of technical review on 
November 18, 2002. Pursuant to the review time frame specified in Environmental Conservation 
Law (ECL) 33-0704.2, a registration decision date of April 17, 2003 was established.
The Department conducted toxicological, ecological effects and environmental fate risk 
assessments for lambda-cyhalothrin and the Spectracide Bug Stop Home Insect Killer product.


TOXICOLOGICAL RISK ASSESSMENT: The formulated product, Spectracide Bug Stop
Home Insect Killer, was not very acutely toxic in laboratory animal studies by the oral, 
dermal, or inhalation routes of exposure. This pesticide product was not irritating to the 
eyes or skin (tested on rabbits) nor was it a dermal sensitizer (tested on guinea pigs).


The Department previously reviewed the toxicity of lambda-cyhalothrin for the pesticide 
products Commodore WP Insecticide and Warrior Insecticide and more recently, for the 
pesticide products Spectracide Triazicide Brand Soil & Turf Insect Killer Granules and 
Spectracide Triazicide Brand Soil & Turf Insect Killer Concentrate. Lambda-cyhalothrin 
was mildly to moderately toxic in acute laboratory animal studies and caused some toxic 
effects in chronic animal feeding studies, but did not cause reproductive or developmental 
effects. This chemical was not oncogenic in chronic rodent feeding studies and was negative 
in a number of genotoxicity studies. The United States Environmental Protection Agency 
(USEPA) classified lambda-cyhalothrin as a Group D carcinogen, not classifiable as to human 
carcinogenicity. The USEPA RfD Peer Review Committee derived an oral reference dose (RfD) 
of 0.001 milligrams per kilogram body weight per day (mg/kg/day) for lambda-cyhalothrin, 
based on a no-observed-effect-level (NOEL) of 0.1 mg/kg/day from a chronic dog feeding study 
(ataxia, muscle tremors and convulsions) and an uncertainty factor of 100.


The USEPA recently reported the results of an aggregate risk assessment for lambda-cyhalothrin 
from all residential, non-dietary uses (Federal Register: January 3, 2003, Volume 68, Number 
2, pages 283-291). For determining margins of exposure (MOEs), the USEPA compared estimated 
short-term and intermediate-term dermal, inhalation, and incidental oral exposures to NOELs 
of 10 mg/kg/day, 0.08 mg/kg/day, and 0.1 mg/kg/day from the 21-day rat dermal toxicity study, 
the 21-day inhalation toxicity study, and the chronic dog oral toxicity study, respectively. 
The USEPA used the dose levels for children playing on treated lawns to estimate risk for 
all residential scenarios. This estimate was considered by the USEPA to be protective for 
all residential exposures because it would exceed those for all other scenarios, including 
those for handlers of lambda-cyhalothrin. For post-application exposures, MOEs ranged from 
700 to 14,700. Generally, the USEPA considers MOEs of 100-fold or greater to provide 
adequate protection.


There are no chemical-specific federal or State drinking water/groundwater standards for 
lambda-cyhalothrin or its degradates. Based on its chemical structure, lambda-cyhalothrin 
falls under the 50 microgram per liter (ug/L) New York State drinking water standard for 
"unspecified organic contaminants" (10 NYCRR Part 5, Public Water Systems). Based on the 
USEPA's oral RfD of 0.001 mg/kg/day and the Department's Water Quality Regulation procedures 
for deriving surface water and groundwater standards and guidance values from non-oncogenic 
effects (6 NYCRR Part 702.5), an ambient water quality value of 7 pg/L can be calculated for 
lambda-cyhalothrin. This value should be used to derive a screening value for comparison to 
estimate impacts to groundwater and surface water.


Spectracide Bug Stop Home Insect Killer was not very acutely toxic. While toxicological 
studies on the active ingredient, lambda-cyhalothrin, indicate that it has some toxic 
properties, labeled use of this product should not pose significant risks to homeowner 
applicators or residents.


ECOLOGICAL EFFECTS and ENVIRONMENTAL FATE RISK ASSESSMENTS: The limited outdoor uses 
represented on the Spectracide Bug Stop Home Insect Killer label present little or no 
potential for impacts to nontarget organisms or groundwater/drinking water. 

CONCLUSION: When used as labeled, the subject product should not cause unreasonable 
adverse effects to humans or the environment. The Department hereby accepts Spectracide Bug 
Stop Home Insect Killer (EPA Reg. No. 9688-176-8845) for registration in New York State. 
Enclosed for your files are the Certificate of Pesticide Registration and New York State 
stamped "ACCEPTED" labeling.


Please note that a proposal by Spectrum Group, or any other registrant, to register a 
product containing lambda-cyhalothrin, whose labeled uses are likely to increase the 
potential for significant exposure to humans or impact to 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 specified in 6 NYCRR Part 326.17.


Please contact Samuel Jackling, Chief of our Pesticide Product Registration Section, at 
(518) 402-8768 if you have any questions.


Sincerely,

Maureen P. 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