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indoxacarb NYS DEC Letter - Registration of a Major Change in Labeled Use Pattern (MCL) 5/04

New York State Department of Environmental Conservation
Division of Solid and Hazardous Materials
Bureau of Pesticides Management, 9th Floor
625 Broadway, Albany, New York  12233-7254
Phone: (518) 402-8788    FAX: (518) 402-9024
Website: www.dec.state.ny.us

						May 18, 2004

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

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

Dear Ms. Loft:

Re:	Registration of a Major Change in Labeled Use Pattern (MCL) for the Active Ingredient
Indoxacarb Contained in the Pesticide Product Hot Shot MaxAttrax Ultra Brand Nest Destroyer
Roach Bait (EPA Reg. No. 9688-193-8845)

	The New York State Department of Environmental Conservation (Department) has completed
review of the application, received November 4, 2003, and supplemental data package, received
December 22, 2003, submitted in support of registration of the referenced product in New York
State.  Hot Shot MaxAttrax Ultra Brand Nest Destroyer Roach Bait (EPA Reg. No. 9688-193-8845)
contains the active ingredient indoxacarb.

	Hot Shot MaxAttrax Ultra Brand Nest Destroyer Roach Bait (0.10% indoxacarb) is packaged
in child-resistant bait stations and the product label bears the statement "For indoor
household use only."

	 The Department previously reviewed indoxacarb in conjunction with the application to
register Avaunt® Insecticide (EPA Reg. No. 352-597).  Avaunt® Insecticide was registered on
March 21, 2002 for control of certain labeled insects on a variety of terrestrial food
crops.  The subject application to register a product labeled for domestic indoor use
represents a major change in labeled use pattern (MCL) for indoxacarb.

	The registration package was deemed complete for purposes of technical review on
February 9, 2004.  Pursuant to the review time frame specified in Environmental Conservation
Law (ECL) §33-0704.2, a registration decision date of July 8, 2004 was established.

	The Department conducted a toxicological risk assessment for indoxacarb and the
formulated roach bait product.

TOXICOLOGICAL RISK ASSESSMENT:

	On an acute basis, the formulated roach bait product was not very toxic to laboratory
animals by either the oral or dermal routes of exposure.  It also was not very irritating
to rabbit skin or eyes.  Although the product was shown to be a skin sensitizer (tested on
guinea pigs), this was not considered by the United States Environmental Protection Agency
(USEPA) to be a critical issue since the product is housed in a bait station and repeated
contact should not occur.  The acute inhalation study of the formulated roach bait product
was waived by the USEPA "because the product form is a thick paste which is not inhalable."

	According to the previous review of this active ingredient (Avaunt® Insecticide),
indoxacarb overall was not very acutely toxic in laboratory animals.  It also did not cause
teratogenic, reproductive or carcinogenic effects and was negative in a number of genotoxicity
studies.  In chronic animal feeding studies, indoxacarb caused some toxicity, including
decreased body weight, body weight gain and food consumption in male and female rats as
well as decreased hematocrit, hemoglobin and red blood cells in females.  Using data from
the chronic rat study, the USEPA Office of Pesticide Programs established a reference dose
for indoxacarb of 0.02 milligrams per kilogram body weight per day (mg/kg/day) based on a
no-observed-effect level of 2.1 mg/kg/day and an uncertainty factor of 100.  A current search
of the scientific literature did not find any significant new information on the toxicity of
indoxacarb.

	The Hot Shot Max Attrax Ultra Brand Nest Destroyer Roach Bait product label indicates
that the bait stations which contain the formulated product are child-resistant.  To support

this claim of child-resistance, the registrant submitted a child-resistant packaging test
report on the Griffin Insect Bait Station.  The registrant verified that the structural design
of the Griffin station is identical to that of the Hot Shot product and, therefore, the data
contained in the report is relevant to the Hot Shot roach bait stations.  These data indicate
that the bait stations meet the criteria for child-resistant effectiveness according to
current testing procedures (16 CFR 1700.20).  Under the conditions of the study, no child
out of 50 children tested was successful in gaining access to the bait within the stations.

	Based on the available information, Hot Shot Max Attrax Ultra Brand Nest Destroyer Roach
Bait should not pose a significant health risk to those individuals who handle this product.
As with most pesticide bait products, the New York State Department of Health had potential
concerns that the Hot Shot product could present a poisoning hazard to children.  However,
the bait station has been proven to be child-resistant which should greatly reduce this
potential poisoning hazard.

REGISTRATION ACTION:

	The Department hereby accepts Hot Shot MaxAttrax Ultra Brand Nest Destroyer Roach Bait
(EPA Reg. No. 9688-193-8845) for registration in New York State.  Enclosed for your files are
the Certificate of Pesticide Registration and New York State stamped "ACCEPTED" label.

	Please note that a proposal by Spectrum Group, or any other registrant, to register a
product containing indoxacarb, whose labeled uses are likely to increase the potential for
significant exposure to humans or impact to the environment, would constitute a MCL.  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, PSUR