PMEP Home Page --> Pesticide Active Ingredient Information --> Insecticides and Miticides --> mevinphos (Phosdrin) to propargite (Omite) --> nithiazine --> nithiazine NYS DEC Letter - Registration as New Active Ingredient 1/03

nithiazine NYS DEC Letter - Registration as New Active Ingredient 1/03

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

January 7, 2003

CERTIFIED MAIL
RETURN RECEIPT REQUESTED


Ms. Catherine Elmi
State Regulatory Manager
Wellmark International
1100 East Woodfield Road, Suite 500
Schaumburg, Illinois 60173

Dear Ms. Elmi:

Re: Registration of One New Pesticide Product, Starbar QuikStrike Fly Abatement Strip (EPA Reg. No. 2724-461), Which Contains the New Active Ingredient Nithiazine

    The New York State Department of Environmental Conservation (the Department) has reviewed your application, received March 5, 2002, and additional information, received July 31, 2002 and September 6, 2002, to register the above-mentioned product in New York State. The Starbar QuikStrike Fly Abatement Strip contains nithiazine which is considered a new active ingredient in New York State (chemical code 441300). The application was deemed complete for purposes of review on September 18, 2002 and a registration decision is due by February 14, 2003.

    The Starbar QuikStrike Fly Abatement Strip (EPA Reg. No. 2724-461) controls nuisance flies through ingestion. The fly bait station contains a triple action fly attractant that, when activated, will attract flies to the fly strip. The active ingredient, nithiazine, is contained in a sugar-based matrix which coats the outside of the strip. Flies begin to die shortly after feeding on the nithiazine containing sugar-based matrix.

    The Department has reviewed the information supplied to date in support of Starbar QuikStrike Fly Abatement Strip (EPA Reg. No. 2724-461) which contains the new active ingredient nithiazine.

    The New York State Department of Health (DOH) stated that the United States Environmental Protection Agency (USEPA) required only limited acute toxicity and mutagenicity studies for the federal registration of Starbar QuikStrike Fly Abatement Strip and the active ingredient nithiazine. All subchronic, chronic, reproductive and developmental toxicity studies were waived, as well as all environmental fate data.

    Nithiazine was not very acutely toxic by the dermal route of exposure in laboratory animal studies, but was moderately toxic by the oral exposure route. Inhalation toxicity studies were waived, as nithiazine is essentially non-volatile. Neither the active ingredient nor the end product (tested as a 5% solution of nithiazine; Starbar contains 1% nithiazine) caused significant dermal irritation in rabbits. Although nithiazine was a severe eye irritant, the end product (tested as a 5% solution) was mildly irritating to the eyes of rabbits. The end product did not show any skin sensitizing properties (tested on guinea pigs). The USEPA did not require skin sensitization testing on the active ingredient. In an acute neurotoxicity study in rats, nithiazine caused slight body weight loss in female rats and decreased motor activity and slightly decreased body temperatures in both sexes at the lowest dose tested (30 milligrams per kilogram body weight). Nithiazine also was negative in a number of genotoxicity studies. A search of the toxicological literature did not find any significant new information on the toxicity of nithiazine.

    The DOH examined a registrant-supplied sample of the Starbar QuikStrike Fly Abatement Strip to evaluate the tamper resistance of its packaging. The DOH's principal concern was whether children would likely gain access to the active ingredient in the QuikStrike Fly Abatement Strip. The DOH found that the active ingredient is contained within a coating on a plastic substrate card that is placed inside a welded plastic shell with small feeding holes. This construction reduces the potential for contact with the active ingredient. The Starbar product is also labeled for use in buildings where children are not likely to gain free access and contains statements indicating that the product should be placed in areas out of the reach of children and animals. Moreover, the product strip contains a fly attractant that has a strong objectionable odor that should serve to further reduce the likelihood that a child would have significant contact with the active ingredient.

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

    Nithiazine was found to be moderately toxic following acute oral exposure in laboratory animals. This chemical also was found to be a severe eye irritant and to cause some acute neurotoxicity in rats. However, the general public is expected to have minimal exposure to nithiazine based on the design of Starbar QuikStrike Fly Abatement Strip and its labeled use.

    The Department concludes that the Starbar QuikStrike Fly Abatement Strip should not have an adverse effect on the health of the general public when used as labeled.

    Therefore, the Department hereby accepts for general use registration in New York State Starbar QuikStrike Fly Abatement Strip (EPA Reg. No. 2724-461) which contains the new active ingredient nithiazine.

    Enclosed are your Certificate of Registration and New York State stamped "ACCEPTED" label.

    Wellmark International is reminded that if New York State registration is requested for this product or for any other product which contains nithiazine with an increased application rate and/or expanded use sites, the product will be considered a Major Change in Labeling and the Department will require an extensive review.

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

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