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Tebufenozide - New Active Ingredient Registration for Confirm 4/02

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
E-Mail: ppr@gw.dec.state.ny.us

April 16, 2002

CERTIFIED MAIL
RETURN RECEIPT REQUESTED


Raymond S. Brinkmeyer, Ph.D.
State Regulatory Leader
Regulatory Success - Americas
Dow AgroSciences LLC
9330 Zionsville Road
Indianapolis, Indiana 46268-1054

Dear Dr. Brinkmeyer:

Re: Registration of the New Active Ingredient Tebufenozide, Contained in the Pesticide Product Confirm 2F Agricultural Insecticide (EPA Reg. No. 62719-420)

    The New York State Department of Environmental Conservation (the Department) has reviewed your application, received March 21, 2002, to register Confirm 2F Agricultural Insecticide (EPA Reg. No. 62719-420) in New York State. The product contains the new active ingredient tebufenozide.

    The Department originally received an application for registration of Confirm 2F Agricultural Insecticide (EPA Reg. No. 707-238) from Rohm and Haas Company on July 23, 1999. Additional information was received September 28, 1999, November 5, 1999, November 16, 1999, February 23, 2000, May 18, 2000 and February 9, 2001 in support of the application to register the new active ingredient tebufenozide in New York State. The application was deemed complete on January 13, 2000 and the legislatively mandated registration decision date was June 9, 2000. Rohm and Haas Company waived the registration date in order to allow time for the Department to review additional information submitted in response to the Department's concerns regarding the registration of Confirm 2F Agricultural Insecticide in New York State.

    Due to the timing of applications on the Confirm 2F label and the unresolved registration issues involved with the application for registration of the federal label, a Special Local Need (SLN) registration was needed. Therefore, the Department issued an SLN registration, which allowed three applications of Confirm 2F Agricultural Insecticide on apples (pome fruits), and prohibited use in Nassau and Suffolk Counties.

    Confirm 2F Agricultural Insecticide mimics the action of the natural insect hormone 20-hydroxyecdysone, the physiological inducer of the molting and metamorphosis process in insects. Confirm 2F is highly active against most lepidopterous larvae while having practically no activity at typical use rates against other orders of insects. The selectivity of Confirm 2F allows for the maintenance of the populations of beneficial and predatory insects, which is a key element in integrated pest management programs. Confirm 2F controls lepidopterous larvae through a novel mode-of-action by the induction of a premature lethal molt which initiates within hours of ingestion of treated crop surfaces. Contact activity has also been observed in some insects. Actual death of the larvae will take several days to occur, although feeding by the insects generally ceases within 24 hours of ingestion.

    The Confirm 2F Agricultural Insecticide label submitted for registration by Dow AgroSciences LLC in New York State contains the following crops and use rates:

CROP SINGLE APPLICATION RATE SEASONAL APPLICATION RATE
bushberries 0.25 lb. Tebufenozide/acre 1.0 lb. Tebufenozide/acre
caneberries 0.25 lb. Tebufenozide/acre 1.0 lb. Tebufenozide/acre
Christmas trees 0.12 lb. Tebufenozide/acre 0.25 lb. Tebufenozide/acre
cole crops, leaf vegetables and turnips (tops and roots) 0.12 lb. Tebufenozide/acre 0.84 lb. Tebufenozide/acre
cotton 0.25 lb. Tebufenozide/acre 1.0 lb. Tebufenozide/acre
cranberries 0.25 lb. Tebufenozide/acre 1.0 lb. Tebufenozide/acre
fruiting vegetables 0.25 lb. Tebufenozide/acre 1.0 lb. Tebufenozide/acre
mint 0.25 lb. Tebufenozide/acre 1.0 lb. Tebufenozide/acre
pome fruits 0.31 lb. Tebufenozide/acre 1.9 lb. Tebufenozide/acre
sugarcane 0.25 lb. Tebufenozide/acre 1.0 lb. Tebufenozide/acre
pecans 0.25 lb. Tebufenozide/acre 1.9 lb. Tebufenozide/acre
walnuts and other tree nut crops 0.47 lb. Tebufenozide/acre 1.9 lb. Tebufenozide/acre


    The New York State Department of Health, the Department's Division of Fish, Wildlife & Marine Resources' Bureau of Habitat and the Department's groundwater staff have reviewed the information submitted to date in support of the application for registration of Confirm 2F Agricultural Insecticide.

    The New York State Department of Health (DOH) stated that neither the active ingredient nor the formulated product was very toxic in acute oral, dermal or inhalation exposure studies in laboratory animals, nor were they dermal sensitizers or very irritating to the eyes or skin. Tebufenozide did not cause oncogenic effects in either the rat or mouse feeding studies. It also was negative in a number of genotoxicity tests. The United States Environmental Protection Agency (USEPA) classified tebufenozide as a Group E (evidence of non-carcinogenicity for humans) carcinogen.

    There are no chemical specific federal or State drinking water/groundwater standards for tebufenozide or its degradates. Based on their chemical structures, these compounds fall under the 50 micrograms per liter (μg/L) New York State drinking water standard for "unspecified organic contaminants" (10 NYCRR Part 5, Public Water Systems). The New York State drinking water standard for the sum of "unspecified organic contaminants" and "principal organic contaminants" is 100 μg/L.

    The available information on tebufenozide and the formulated Confirm 2F Agricultural Insecticide product indicates that they were not very acutely toxic in laboratory animal studies. The data also indicate that tebufenozide did not cause oncogenic, genotoxic or teratogenic effects and dietary exposure was estimated to be fairly low from the labeled use of Confirm. However, tebufenozide did cause blood and spleen effects at relatively low doses and should be classified as "Restricted Use" in New York State in order to limit its use to trained applicators.

    The Department's groundwater staff stated that available environmental fate studies reported that tebufenozide and one of its degradates (RH-2651), have soil adsorption coefficients (Koc's) of 351-894 and 76-156, respectively. These Koc's indicate a moderate to high mobility and a capacity to leach through soil and contaminate groundwater. The USEPA has indicated concerns for ground and surface water based on the similarities to chemicals detected in the groundwater. The Confirm 2F Agricultural Insecticide label contains the following Environmental Hazards Statement: "This pesticide demonstrates the properties and characteristics associated with chemicals detected in groundwater. The use of this chemical in areas where the water table is shallow may result in groundwater contamination."

    Tebufenozide is persistent and modeling shows it accumulates. Modeling projects between 11 and 40 ppb during the 10 year simulation. The proposed groundwater standard for tebufenozide, as an unspecified organic contaminant, is 50 μg/L (ppb). Modeling projects that leachate would exceed the trigger value of 25 ppb at about 7 years for the labeled rate on pome fruits. All modeling was conducted using values representative of Long Island soil. Therefore, based on the Department's modeling results, the persistence of tebufenozide and the USEPA's concerns, this product should not be used in Nassau and Suffolk Counties unless groundwater monitoring is performed.

    The Department's Division of Fish, Wildlife & Marine Resources' Bureau of Habitat (BOH) has objections to the use of Confirm 2F Agricultural Insecticide according to the federally accepted label, due to concerns for chronic toxicity to non-target aquatic invertebrates resulting from anticipated runoff. In response to these concerns, Rohm and Haas Company submitted additional information, received February 9, 2001, which included PRZM3.12 Runoff Modeling of Confirm for apple orchard applications in New York State, an internal Rohm and Haas Company memo entitled "Aquatic Risk Assessment for Tebufenozide Based on 0.5% Runoff," and a literature summary which included 59 references, 34 of which had not been previously submitted to the Department.

    Rohm and Haas contended, based on their modeling, that 0.5% runoff represents a 90th percentile worst case rate and that when used in aquatic risk assessment it shows that tebufenozide use poses no risk to non-target organisms. The Department does not agree with this contention.

    The most recent USEPA Environmental Fate and Effects Division risk assessment for tebufenozide, dated March 1999, showed that USEPA reviewers (utilizing PRZM aquatic modeling) predicted the following water concentrations in a two meter deep pond;

        • Mean of annual values 5.4 ppb
        • Upper 90% confidence limit on mean 5.6 ppb
        • Water column 1 in 10 yr peak conc. 8.7 ppb
        • Water column 1 in 10 yr 21 day conc. 8.3 ppb
        • Water column 1 in 10 yr 60 day conc. 7.9 ppb

    The BOH's aquatic risk modeling for tebufenozide utilizes runoff rates of 0.5%, 1.5%, and 3.0%. The USEPA PRZM aquatic modeling values listed above are fairly consistent with BOH modeling results which predict water concentrations in a six foot deep pond of 3.83 ppb and 7.66 ppb at 1.5% and 3.0% runoff, respectively. Use of 0.5% as a worst case upper bound is likely to underestimate risk. In the September 6, 2000 BOH review of tebufenozide, which was in response to the Rohm and Haas Company contention that 0.5% runoff or less should be used to evaluate aquatic risk, BOH asked specifically for runoff data showing that the 0.5% runoff rate is valid. When runoff rate results from aquatic risk modeling are questioned, the Department requires the submission of data from an actual runoff study. Rohm and Haas Company maintained that tebufenozide use would pose no risk to non-target organisms and that runoff data was not needed.

    The Department reviewed all information submitted in support of registration of Confirm 2F Agricultural Insecticide label in New York State and still has concerns regarding the potential of tebufenozide to impact groundwater and the fish and wildlife resources in New York State when used according to the federally accepted label.

    Rohm and Haas Company and Dow AgroSciences LLC, on August 9, 2001, submitted a request to the USEPA for the transfer of pesticide registrations from Rohm and Haas Company to Dow AgroSciences LLC. The USEPA approved the transfer on September 21, 2001.

    The Department provided Dow AgroSciences LLC, the new owner of the Confirm 2F Agricultural Insecticide product, copies of reviews and information regarding the Department's concerns for the use of the federally accepted Confirm 2F label in New York State.

    Dow AgroSciences LLC, on March 5, 2002 and March 13, 2002, submitted paperwork to the USEPA for the addition of the following New York State specific label language to their federally accepted Confirm 2F Agricultural Insecticide product label:
    The addition of the above mentioned New York State specific label language should adequately protect sensitive non-target organisms from the potential effects of runoff and protect the groundwater resources of Nassau and Suffolk Counties.

    Therefore, the Department hereby accepts for restricted use registration in New York State the new active ingredient application of Confirm 2F Agricultural Insecticide (EPA Reg. No. 62719-420) with the final printed labeling containing the New York State specific language.

    Dow AgroSciences LLC is reminded that if New York State registration is requested for this product, or for any other product which contains tebufenozide, with expanded use sites and/or a different formulation, the product will be considered a Major Change in Labeling and the Department will require an extensive review.

    Confirm 2F Agricultural Insecticide is classified as "Restricted" use according to 6NYCRR 326.23 (e) and as such, the product is restricted in its purchase, distribution, sale, use, and possession in New York State. According to the New York State Department of Environmental Conservation Regulations 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."

    Furthermore, the product may only be purchased and used by certified applicators in New York State.

    Please contact the Pesticide Certification Section, at (518) 402-8748, if you require information concerning commercial permits or pesticide applicator certification.

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

    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