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Buprofezin - Registration for Major Change in Labeling in Several Products 8/04

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

August 13, 2004

CERTIFIED MAIL
RETURN RECEIPT REQUESTED


Ms. Marie A. Maks
Manager Regulatory Affairs
Nichino America, Incorporated
4550 New Linden Hill Road, Suite 501
Wilmington, Delaware 19808

Dear Ms. Maks:

Re: Registration for the Major Change in Labeling for Applaud 70 WP Insect Growth Regulator, Courier Insect Growth Regulator and Talus Insect Growth Regulator (EPA Reg. No. 71711-15) Containing the Active Ingredient Buprofezin

    The New York State Department of Environmental Conservation (Department) has reviewed the application and supporting data submitted by Nichino America, Inc., to register the pesticide products Applaud 70 WP Insect Growth Regulator (EPA Reg. No. 71711-15), Courier Insect Growth Regulator (EPA Reg. No. 71711-15) and Talus Insect Growth Regulator (EPA Reg. No. 71711-15) in New York State.

    The referenced application was received December 9, 2003, and additional information received January 12, 2004 and March 16, 2004. The application was deemed complete for purposes of review on February 2, 2004 and a registration decision is due by August 30, 2004 (Nichino requested a 60-day extension, which was granted, so that New York State specific language could be updated on the Talus label).

    The Applaud, Courier and Talus products have the same formulation and contain the active ingredient buprofezin (2-tert-butylimino-3-isopropyl-phenylperhydro-1,3,5-thiadiazin-4-one) (chemical code 275100). Applaud 70 WP Insect Growth Regulator is currently registered in New York State for control of insects on almonds, bananas, citrus, cotton, cucumbers, melons, pumpkins, squash, grapes, lettuce and tomatoes. The revised label would add use on longan, lychee, pulasan, rambutan and Spanish lime and transfers use on cucumbers, melons, pumpkins, squash, lettuce and tomatoes to the alternate brand name, Courier Insect Growth Regulator. Also, use on snap beans is added to the Courier product label. The Talus product is labeled for control of insect damage to outdoor and greenhouse ornamentals, and greenhouse tomatoes. The additional proposed uses of buprofezin in Applaud 70 WP Insect Growth Regulator and the alternate brand names Courier and Talus have been determined to represent a major change in labeled use pattern for this active ingredient in New York State.

    The Applaud 70 WP product and its active ingredient buprofezin were previously reviewed November 2002 and May 2003. Neither the Applaud 70 WP product nor buprofezin was very toxic, irritating or caused skin sensitization following acute exposures in laboratory animals. Also, buprofezin did not cause any significant developmental or reproductive effects. However, buprofezin caused liver and thyroid gland effects at relatively low doses as well as causing a limited increase in liver tumors in female mice. Buprofezin was negative for carcinogenicity in male mice and rats and was negative in numerous genotoxicity studies. Based on these data, the United States Environmental Protection Agency (USEPA) classified buprofezin as having "suggestive evidence of carcinogenicity, but not sufficient to assess human carcinogenic potential." A current search of the toxicological literature did not find any significant new information on the toxicity of buprofezin.

    The USEPA originally calculated an oral reference dose (RfD) for buprofezin of 0.01 milligrams per kilogram body weight per day (mg/kg/day) based on the no-observed-effect level (NOEL) from the rat chronic feeding/oncogenicity study (1 mg/kg/day) and an uncertainty factor of 100. For the purpose of evaluating dietary risks from exposure to this chemical through consumption of crops treated with the Applaud 70 WP product, a chronic population adjusted dose (cPAD) of 0.0033 mg/kg/day was used. This value was based on the RfD of 0.01 mg/kg/day and an additional uncertainty factor of three used to account for the lack of a developmental neurotoxicity study. In a more recent evaluation of the toxicology database for buprofezin, the USEPA concluded that this neurotoxicity study is not required. Consequently, the additional uncertainty factor of three was decreased to a value of one, which in turn increased the cPAD to 0.01 mg/kg/day.

    The USEPA established tolerances for buprofezin residues in or on snapbeans at 0.02 parts per million (ppm); and longan, lychee, pulasan, rambutan and Spanish lime each at 0.30 ppm. Tolerance levels for buprofezin residues were previously reported on the other crops treated with this active ingredient in the Applaud 70 WP and Courier (alternate brand name) products. Using the revised cPAD of 0.01 mg/kg/day, the USEPA estimated that chronic dietary exposure to buprofezin residues would be 32% of the cPAD for the general United States population, 18% for infants less than one year old and 63% for children one to two years old. This chronic exposure analysis is based on the conservative assumption that 100% of crops are treated and that with few exceptions, these crops contain tolerance level residues.

    In the previous review of the Applaud 70 WP product, the results of a risk assessment were summarized for dermal and inhalation exposure of workers (mixer/loader/handlers) to buprofezin, using lettuce as a representative crop, since according to the USEPA, it is the labeled crop with the greatest acreage per farm. This risk assessment showed that these workers as well as those involved in harvesting (i.e., post-application exposure) are exposed to levels of buprofezin from use of the Applaud 70 WP product that should not pose significant risks. A more recent occupational risk assessment conducted by the USEPA for workers using buprofezin in the form of Talus Insect Growth Regulator to treat ornamentals and greenhouse tomatoes showed that the margins of exposure (MOEs) for dermal and inhalation exposures combined ranged from 680 to 2,600 (for treatment of ornamentals) and 820 to 5,300 (for treatment of greenhouse tomatoes). It was assumed that workers wore long-sleeved shirts, long pants, shoes plus socks and gloves (all required by the label). For post-application exposures to ornamentals and greenhouse grown tomatoes, the estimated MOEs were 260 and 3,100, respectively. Generally, the USEPA considers MOEs of 100-fold or greater to provide adequate worker protection.

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

    Overall, the information in this registration package for the Applaud 70 WP, Courier and Talus pesticide products, along with the information previously reviewed for the Applaud 70 WP product, indicate that the labeled uses of buprofezin should not pose significant risks to workers or the general public. Nevertheless, buprofezin appears to have some weak carcinogenic potential and we generally have concerns for registering a pesticide product that has carcinogenic potential unless either the need for the product is significant or it replaces products that pose greater risk. In this regard, the registrant submitted data prior to the submission of the present registration package, which in conjunction with information we gathered, provides an adequate basis for evaluating the comparative risks of the Applaud/Courier/Talus products. As indicated in our earlier review of this information in May 2003, the alternative active ingredients, with the exception of the active ingredient pyriproxyfen, either have specific toxicity concerns (e.g., neurotoxicity, greater evidence of carcinogenicity, developmental/reproductive toxicity) or are overall no less toxic than buprofezin. In addition, the application rates for the alternative products often exceed those of the Applaud/Courier/Talus products. Consequently, the registration of these three products possibly could reduce the use of other products that pose greater risks to workers and the general public.

    A January 2003 review indicated there should be no impacts to fish or wildlife resources when the first buprofezin product, Applaud 70 WP, was applied at full labeled rates. The new Talus IGR and Courier IGR products include directions for use on new crops and new locations, snap beans and container and greenhouse grown ornamentals respectively. While the new uses significantly increase the New York acreage that buprofezin may be used on, they also should not adversely affect fish or wildlife resources.

    The Department previously reviewed this active ingredient for use on almonds, bananas, citrus, cotton (which are not grown in NY) and cucumbers, grapes, lettuce, melons, pumpkins, squash and tomatoes (at a maximum of 1.0 lb ai/a/season for grapes). Use is prohibited in Nassau and Suffolk Counties on the current Applaud label.

    All three products contain 70% by weight active ingredient in water soluble packages. Applaud and Talus contain three 0.36 pound packages within a 1.08 pound package and Courier contains five one-pound packages within a five-pound package. The mixed products may be applied aerially or by ground application; application through an irrigation system is not allowed. All of the Applaud products are to be applied in a minimum finished spray volume of five gallons per acre by air, or 20 gallons per acre by ground.

    Nichino America, Inc., is applying to add uses to the Applaud label for longan, lychee, pulasan, rambutan and Spanish lime. These crops are not grown in New York State (NYS). Applaud is already registered for use on grapes in NYS, but use is prohibited on Nassau and Suffolk Counties, New York, so this label does not require any additional review.

    Nichino America, Inc., is applying to register Courier for use on cotton, cucurbits (including cucumbers, melons, pumpkins, squash), lettuce, snap beans, and tomatoes. The new use on this label is snap beans, at 0.38 lb ai/app with two applications per crop cycle. In New York State, only one crop cycle of snap beans can be grown per year due to the climate. The maximum application of snap beans is the same as that for crops previously approved on the Applaud label.

    Nichino America, Inc., is applying to register Talus, which is labeled for use on outdoor and greenhouse ornamentals in containers, and greenhouse tomato use. The proposed ornamental use rate is 1.2 lb ai/a/season, which is higher than the previously reviewed rate of Applaud at 1.0 lb ai/a/season. The addition of New York State specific label language stating "Not for Sale, Sale into, Use, or Distribution in Nassau and Suffolk Counties, New York" needed to be added to this label to adequately protect the groundwater resources of Nassau and Suffolk Counties.

    The inerts do not appear to be solvent carriers.

Technical Review

Hydrolysis: This study was found to be acceptable. Buprofezin was stable in pH 7 and 9 aqueous buffer solutions. The half-life was estimated to be 51 days in a pH 5 buffer solution. In pH 5 solution, the major degradate BF-25 was found at 19% at 30 days. BF-12 reached 9.9% at day 30, and BF-11 was found at <0.8%.

Aqueous Photolysis: The USEPA indicated that these studies provided useful information, and can be used to fulfill the USEPA requirements. The phenyl ring-labeled buprofezin degraded with a registrant-calculated half-life of 33 days. BF-21 was found at a maximum of 9.7% at day 30, and BF-22 was found at 2.2% at day 30. USEPA indicated that photodegradation does not seem to be a rapid process for this chemical.

Soil Photolysis: This study was found to be acceptable. Buprofezin was photolytically stable in sandy clay loam soils up to 30 days.

Aerobic Soil Metabolism: This study was found to be acceptable. Phenyl ring-labeled buprofezin degraded with a registrant-calculated half-life of 24.4 days in a sandy loam soil incubated up to 181 days (calculated using a nonlinear regression model). Phenyl ring-labeled buprofezin degraded with a registrant-calculated half-life of 59.0 days in a sandy loam soil incubated up to 364 days (calculated using a nonlinear regression model). Based on reviewer-calculated first and second half-lives, the dissipation appeared to be biphasic. The June 23, 2001 EFED review indicated that the first order half-life ranged from 37 to 101 days. No major degradates were detected.

Anaerobic Aquatic Metabolism: This study was found to be acceptable. Phenyl ring-labeled buprofezin was stable in anaerobic flooded loam sediment up to 364 days. No major degradates were detected in either the soil or water phase.

Adsorption/Desorption: Buprofezin was shown to be immobile in batch equilibrium studies. Freundlich Kads values in (mL/g) were 85.3 for the clay loam soil, 276.8 for the silty clay loam soil, 68.8, 90.1 and 87.4 for the three sandy loam soils, 69.5 for the loamy sand soil, and 10.5 for the sand soil. Freundlich Kdes values in (mL/g) were 173.5 for the clay loam soil and 330.5 for the silty clay loam soil, 64.7, 85.0 and 118.1 for the three sandy loam soils, 70.7 for the loamy sand soil and 7.7 for sand soil.

Aged Leaching: This study was found to be supplemental. Buprofezin aged under aerobic conditions for 30 days was not mobile in columns of loamy sand soil, and was slightly mobile in columns of sandy loam soil leached with distilled water.

Field Dissipation: This study was found to be scientifically valid and upgradable. At an application rate of 1.5 lb ai/a (four applications of 0.38 lb ai), on bare ground loamy sand (NC) and sandy loam (CA), the parent had half-lives of 38.1 days and 37.5 days. However, the first California half-life was 28 days, and the replicates ranged from 61-184 days. In both studies, the parent was found in the 0-7.5 cm depth. BF-12 was also found in that depth range.

Computer Modeling: Modeling was done on Riverhead sand, using 1.0 ai/a/yr, a Freundlich Kdes of 89 (the average of the three sandy loam soils) and an aerobic half-life of 37 days (the lower aerobic metabolism half-life and the field dissipation half-life). The model projected peaks starting in the second year ranging between 0.1 and 1.6 ppb. Changing to the longer aerobic half-life of 101 days, the model projected peaks starting in the second year ranging from about three to 14 ppb.

Ground Water: According to the Department of Health (DOH), there are no chemical-specific federal or State drinking water/groundwater standards for buprofezin. Based on its chemical structure, this compound falls under the 50 microgram per liter New York State drinking water standard for "unspecified organic contaminants" (10 NYCRR Part 5, Public Water Systems).

    The Department's review of Applaud 70 WP Insect Growth Regulator, Courier Insect Growth Regulator and Talus Insect Growth Regulator (EPA Reg. No. 71711-15) expressed a concern for possible groundwater/drinking water contamination in sandy soil conditions such as exist on Long Island. To address this concern, the above products are registered with a Long Island prohibition statement.

    As such, Applaud 70 WP Insect Growth Regulator, Courier Insect Growth Regulator and Talus Insect Growth Regulator (EPA Reg. No. 71711-15) are prohibited in their sale, sale into, distribution and or use in Nassau and Suffolk Counties of New York State. Furthermore, these products may only be purchased and used by a certified applicator in New York State. In order to track and ensure the reporting of buprofezin sales and use under the Pesticide Reporting Law (PRL), Applaud 70 WP Insect Growth Regulator, Courier Insect Growth Regulator and Talus Insect Growth Regulator (EPA Reg. No. 71711-15) will be classified "Restricted Use" in New York State.

    Applaud 70 WP Insect Growth Regulator, Courier Insect Growth Regulator and Talus Insect Growth Regulator (EPA Reg. No. 71711-15) as noted in the "RESTRICTION" column on the Certificate, are classified as "Restricted Use" under rules and regulations 6 NYCRR Part 326.23(e). As such, these products are restricted in their purchase, sale, sale into, distribution, use and possession in New York State.

    According to 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."

    Should you require information to obtain a commercial permit, please contact the Pesticide Certification Section, at (518) 402-8748.

    The Pesticide Reporting Law (PRL) in the Environmental Conservation Law Article 33 Title 12 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 protection. If no sales are made within New York State, a report still must be filed with the Department indicating this is the case.

    If you need information relating to the Pesticide Reporting Law, or annual report forms, please visit the Department's website at http://www.dec.state.ny.us/website/dshm/pesticid/prl.htm or call 1-888-457-0110 (toll free within New York State). Out-of-State callers may contact the Pesticide Reporting Section, at (518) 402-8765.

    Given the above information, the Department hereby accepts Applaud 70 WP Insect Growth Regulator, Courier Insect Growth Regulator and Talus Insect Growth Regulator (EPA Reg. No. 71711-15) for registration as "Restricted Use" pesticide products in New York State provided the label states that the product is Not for Sale, Sale into, Distribution and or Use in Nassau and Suffolk Counties of New York.

    The addition of the above-mentioned New York State specific label language should adequately protect the groundwater resources of Nassau and Suffolk Counties.

    Enclosed are the Certificate of Pesticide Registration and New York State stamped "ACCEPTED" labels.

    If you have any questions, please contact 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
W. Smith - Cornell University, PMEP