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Imidacloprid - Registration of a Major Change in Labeled (MCL) Use Pattern Contained in the Pesticide Products Premise Gel Insecticide and Premise Foam 4/05

New York State Department of Environmental Conservation
Division of Solid & Hazardous Materials

Bureau of Pesticides Management
Pesticide Product Registration Section
625 Broadway, Albany, New York 12233-7257
Phone 518-402-8768     FAX 518-402-9024
Website: http://www.dec.state.ny.us/website/dshm/pesticid/pesticid.htm
E-Mail: ppr@gw.dec.state.ny.us

April 7, 2005

CERTIFIED MAIL
RETURN RECEIPT REQUESTED


Mr. Adrian Krygsman
Manager, Registration
Bayer Environmental Science
95 Chestnut Ridge Road
Montvale, New Jersey 07645

Dear Mr. Krygsman:

Re: Registration of a Major Change in Labeled (MCL) Use Pattern for Imidacloprid Contained in the Pesticide Products Premise Gel Insecticide (EPA Reg. No. 432-1368) and Premise Foam (EPA Reg. No. 432-1391)

The New York State Department of Environmental Conservation (Department) has completed a technical review of the data package and application (received August 2, 2004) submitted in support of registration of the referenced products. Premise® Gel Insecticide (EPA Reg. No. 432-1368) and Premise® Foam (EPA Reg. No. 432-1391) contain the active ingredient imidacloprid.

The Department hereby accepts Premise® Gel Insecticide (EPA Reg. No. 432-1368) and Premise® Foam (EPA Reg. No. 432-1391) for registration as "Restricted Use Pesticides" in New York State.

Premise® Gel Insecticide (0.001% imidacloprid) is a ready-to-use formulation of imidacloprid intended for use in spot treatments for the control of existing infestations of subterranean termite species of Coptotermes, Heterotermes, Reticulitermes, and Zootermopsis. Premise® Gel can also be used as a spot treatment to control existing infestations in trees, utility poles, fencing and decking materials, landscape timbers and similar nonstructural wood.

Premise® Foam (0.05% imidacloprid) is a ready-to-use formulation of imidacloprid intended for use as a spot treatment to kill existing infestations of subterranean termite species of Coptotermes, Heterotermes, Reticulitermes, and Zootermopsis and other wood-destroying insects. Premise® Foam can also be used as a spot treatment to control existing infestations in trees, utility poles, fencing and decking materials, landscape timbers and similar nonstructural wood.

Imidacloprid is an insecticidal component of products registered for a variety of uses including agricultural, commercial turf and ornamental and noncommercial (homeowner) lawn, garden and pet products. Due to the reevaluation of imidacloprid products labeled for outdoor use in New York State, the subject applications were classified as a major change in labeled (MCL) use pattern.

The application package was deemed complete for purposes of technical review on December 23, 2004 following two determinations of incompleteness (08/18/04 and 10/15/04). Pursuant to the review time frame specified in Environmental Conservation Law (ECL) §33-0704.2, a registration decision date of May 22, 2005 was established.

TOXICOLOGICAL RISK ASSESSMENT:
In order to satisfy the requirement for acute toxicity data on the Premise® Gel Insecticide product, the registrant submitted data on the product Imidacloprid Cockroach Gel. This latter product is an acceptable surrogate for Premise® Gel Insecticide since it contains a much higher percentage of the active ingredient imidacloprid (about 2,000-fold greater), but is otherwise very similar in composition. On an acute basis, Imidacloprid Cockroach Gel was not very toxic to laboratory animals by either the oral or dermal routes of exposure. This formulated product was not very irritating to rabbit skin or eyes and did not cause dermal sensitization (tested on guinea pigs). The United States Environmental Protection Agency (USEPA) waived the requirement for an acute inhalation toxicity study based on the product's formulation ("thick, syrup-based paste") and imidacloprid's low vapor pressure (1.5 x 10-9 millimeters mercury at 20 degrees Celsius).

The Premise® Foam product was not very toxic to laboratory animals orally or dermally exposed to this formulated product on an acute basis. The product was neither very irritating to the eyes or skin (tested on rabbits) nor was it a skin sensitizer (tested on guinea pigs). The USEPA waived the requirement for an acute inhalation toxicity study because the foaming nature of the product would limit the formation of respirable particles.

In the past, the New York State Department of Health reviewed imidacloprid in a number of pesticide products including Merit 75 WSP Insecticide (EPA Reg. No. 3125-439) and Merit 75 WP (EPA Reg. No. 3125-421). Imidacloprid was not very acutely toxic in laboratory animal studies, did not cause oncogenic effects and was generally negative in genotoxicity studies. Some developmental effects (at maternally toxic doses) were reported in rats and rabbits, but no effects on reproduction were reported in a rat multigeneration study. The USEPA Office of Pesticide Programs developed a reference dose of 0.057 milligrams per kilogram body weight per day (mg/kg/day) based on a no-observed-effect level (NOEL) of 5.7 mg/kg/day in a chronic rat feeding study (significantly increased incidence of mineralized particles in the thyroid colloid of male rats) and an uncertainty factor of 100. A current search of the toxicological literature did not find any significant new information on the toxicity of imidacloprid.

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

The available information on imidacloprid and the formulated products Premise® Gel Insecticide and Premise® Foam indicates that they were not very acutely toxic in laboratory animal studies. Although data from chronic and developmental/reproductive studies showed that imidacloprid has the potential to cause some toxicological effects, the expected exposure from using these two Premise® products should not pose a risk to the general public or to workers. To minimize exposure to the general public, the products are labeled "For use by individuals/firms licensed or registered by the State to apply termiticide products." Furthermore, the labels prohibit the use of these products in the open or on exposed surfaces, or areas accessible to children. The labels also instruct users to seal holes drilled in living areas following treatment. Worker exposure to the active ingredient and other components in these two Premise® products also should be quite low since the products are dispensed in low quantities as either a gel or a foam, and neither Premise® product contains volatile components (with the exception of a small amount of propellant in the foam product).

ENVIRONMENTAL FATE RISK ASSESSMENT:
Premise® Gel Insecticide (EPA Reg. No. 432-1368) is labeled for use as a ready-to-use spot treatment in termite galleries or voids in structures to control subterranean termite species of Coptotermes, Herterotermes, Reticulitermes and Zootermopsis. It may also be used in trees, utility poles, fencing and decking materials, landscape timbers and similar nonstructural wood. The product contains 0.001% active ingredient and is labeled for use by certified applicators only. It is packaged in four 20 grams tubes. Each tube contains 0.0002 grams of active ingredient for a total of 0.0008 grams or 1.76 x 10-6 pounds active ingredient.

Premise® Foam (EPA Reg. No. 432-1391) is labeled for use in feeding galleries, structural voids, nest sites in trees or nonstructural constructions (e.g., posts, fences, decks) to control subterranean termite species of Coptotermes, Herterotermes, Reticulitermes and Zootermopsis. The product contains 0.05% active ingredient and is labeled for use by certified applicators only as a temporary treatment until final treatment of the structure with soil and foundations treatments can be completed. It is packaged in an 18 ounce can which contains 0.255 grams of active ingredient or 5.62 x 10-4 pounds active ingredient.

Given the use pattern and that the application rate is so small compared to the agricultural and even the homeowner use rates, and the fact that these products will be classified "Restricted Use," no adverse impact to groundwater/drinking water is anticipated from use of these products as labeled.

REGISTRATION ACTION:
Both Premise® Gel Insecticide and Premise® Foam product labels bear the text: "For use by individuals/firms licensed or registered by the state to apply termiticide products. States may have more restrictive requirements regarding qualifications of persons using this product. Consult the structural pest control regulatory agency of your state prior to use of this product." Therefore, the Department accepts Premise® Gel Insecticide (EPA Reg. No. 432-1368) and Premise® Foam (EPA Reg. No. 432-1391) for registration as "Restricted Use Pesticides" in New York State. Enclosed for your files are the Certificate of Pesticide Registration and New York State stamped "ACCEPTED" labeling.

Premise® Gel Insecticide and Premise® Foam contain a "YES" in the RESTRICTION column on the Certificate and are classified as "Restricted Use Pesticides" under rules and regulations 6 NYCRR Part 326.2(g). As such, these products are restricted in their purchase, distribution, sale, use and possession in New York State.

According to Department regulations specified in 6 NYCRR 326.3(a): "It shall be unlawful for any person to distribute, sell, offer for sale, purchase for the purpose of resale, or possess for the purpose of resale, any restricted pesticide unless said person shall have applied for, and been issued a commercial permit." If you require information regarding a commercial permit, please contact Maggie O'Neil, Chief, Pesticide Reporting and Certification Section, at (518) 402-8748.

The Pesticide Reporting Law (PRL) requires all certified commercial pesticide applicators to report information annually to the Department regarding each pesticide application they make. Commercial pesticide retailers are required to report all sales of restricted pesticide products and sales of general use pesticide products to private applicators for use in agricultural crop production. If no sales are made within New York State, a report still must be filed with the Department indicating this is the case. Information relating to the PRL or annual report forms is available at the Department's website at http://www.dec.state.ny.us or from the Pesticide Reporting and Certification Section at (518) 402-8748.

Please note that a proposal by Bayer Environmental Science or any other registrant to register a product containing imidacloprid, 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
W. Smith, Cornell University, PSUR