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Pyridaben - Major Label Change for Pyramite 8/01


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


August 10, 2001

CERTIFIED MAIL
RETURN RECEIPT REQUESTED



Ms. Laura L. Whatley, Ph.D.
State Registration Specialist
BASF Corporation
Agricultural Products
PO Box 13528
Research Triangle Park, NC 27709-3528


Dear Dr. Whatley:

Re: Registration of a Major Change in Labeling for the Active Ingredient Pyridaben, Contained in the Pesticide Product Pyramite Miticide/Insecticide (EPA Reg. No. 7969-125)

    The New York State Department of Environmental Conservation (the Department) has reviewed your application, received July 25, 2000, and additional information, received September 8, 2000, to register the above-mentioned product in New York State. Pyramite Miticide/Insecticide contains the active ingredient pyridaben which is currently registered in New York State for control of mites and whiteflies on ornamental plants, flowers and foliage (non-food) crops in greenhouses; and for use to control mites on apples, pears and almonds. The new Pyramite Miticide/Insecticide label adds the use of pyridaben on grapes, apricots, cherries, nectarines, peaches, pistachio, plums, prunes and the tree nut group.

    The application was deemed complete for purposes of review on September 13, 2000 and a registration decision date was set for February 20, 2001. However, during the review of the application, an error was discovered in the "Environmental Hazards" section of the Pyramite label. The bee precautionary statements were inadvertently deleted by the registrant from the Environmental Hazards section. The comment letter, which accompanied the United States Environmental Protection Agency (USEPA) stamped "ACCEPTED with COMMENTS" label dated June 28, 2000, listed eight revisions which were to be made to the label. During the revision of the label, the bee precautionary statements were inadvertently removed. BASF submitted the revised label to the USEPA. The USEPA stamped the label "ACCEPTED" on October 17, 2000 without noting the omission of the bee precautionary statements.

    BASF Corporation waived the February 20, 2001 registration decision date, on February 16, 2001, in order to allow time for the review and acceptance of the corrected label by the USEPA.

    The Department has reviewed the information supplied to date in support of registration of the major change in labeling application of Pyramite Miticide/Insecticide (EPA Reg. No. 7969-125).

    The New York State Department of Health (DOH) stated that according to the registrant, acute toxicity studies were not conducted with the Pyramite formulated product (60% pyridaben); acute toxicity studies conducted with SanMite (75% pyridaben) were cited. Neither pyridaben nor SanMite was highly toxic in acute exposure studies by the oral or dermal routes. These materials were not irritating to the skin and were not reported to be skin sensitizers. However, SanMite caused significant eye irritation and damage, and also was quite potent following acute inhalation exposures. Pyridaben was not oncogenic, or teratogenic nor did it cause reproductive effects and was negative in several genotoxicity studies. However, in a rabbit dermal and a rat oral development toxicity study, pyridaben caused some developmental effects (retarded fetal growth and incomplete skeletal ossification) at doses greater than those that caused maternal effects. The USEPA established a reference dose (RfD) of 0.005 milligrams per kilogram per day (mg/kg/day), based in a no-observed-effect level of 0.5 mg/kg/day in a one-year dog feeding study (decreased body weight gain) and an uncertainty factor of 100. A current search of the toxicological literature did not find any significant new information on the toxicity of pyridaben.

    The USEPA established tolerances for pyridaben residues in or on apples at 0.5 parts per million (ppm), wet pomace at 0.75 ppm, almond hulls at 4.0 ppm, apricots at 0.05 ppm, cherries at 0.05 ppm, grapes at 1.5 ppm, nectarines at 2.5 ppm, pears at 0.75 ppm, plums at 2.5 ppm, prunes at 2.5 ppm and the tree nut group at 0.05 ppm. The USEPA estimated that the chronic dietary exposure to these residues would be up to 64 percent of the chronic Population Adjusted Dose (equivalent to the RfD) for the most highly exposed subgroup, non-nursing infants less than one year old. This chronic exposure analysis is based on the assumption that 100 percent of crops are treated and contain anticipated tolerance residue levels.

    There are no chemical-specific federal or State drinking water/groundwater standards for pyridaben. Based on its chemical structure, pyridaben 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). Based on the RfD of 0.005 mg/kg/day and the DEC Water Quality Regulation procedures for deriving surface and groundwater standards and guidance values from non-oncogenic effects (6 NYCRR Part 702.5) an ambient water quality value for pyridaben of 35 micrograms per liter can be calculated.

    According to data from laboratory animals exposed to SanMite, Pyramite has the potential to cause significant eye irritation and damage and to be quite toxic following acute inhalation. However, Pyramite is contained in water-soluble packages and its label requires applicators and other handlers to wear personal protective equipment which includes waterproof gloves, protective eyewear and a dust/mist filtering respirator. These factors mitigate the exposure potential of Pyramite to workers. The registrant submitted a worker exposure assessment for application of pyridaben to apple trees. From this assessment, margins of exposure ranging from about 400 to 22,000 were calculated for workers wearing personal protective equipment. Generally, margins of exposure of 100-fold or greater are considered adequate by the USEPA.

    In a previous review of Pyramite and its active ingredient pyridaben, the DOH noted that if the registrant applied for registration of additional food crop uses in the future, exposure could increase and possibly become an issue of concern. However, as indicated as above, the estimated dietary exposure did not exceed the chronic Population Adjusted Dose for the most highly exposed subgroup, non-nursing infants. In fact, current estimates of exposure decreased from previous estimates for those crops for which tolerances have been established due to the generation of new data that indicate lower residue levels (some tolerances were lowered accordingly). Based on current evaluations, registration of Pyramite Miticide/Insecticide in New York State should not pose a significant risk to public health.

    The Department's Division of Fish, Wildlife & Marine Resources' Bureau of Habitat (BOH) completed a technical review of Pyramite for use on apples, pears, and almonds on March 3, 1998. The reviewer concluded that Pyramite, when used as labeled, should not adversely impact New York State fish or wildlife resources. The current submission adds use on apricot, cherry, nectarine, peach, plum, prune, grapes, pistachio, and the tree nut crop group. Inclusion of the stone fruits and grapes in the allowed uses will result in approximately forty thousand additional acres on which Pyramite may be applied. The application rates and intervals between applications for the new uses are identical to those for the previously registered use patterns. As such the previous BOH assessment is applicable to the new uses as well. Therefore, the use of Pyramite Miticide/Insecticide as labeled should not adversely impact the fish and wildlife resources of New York State.

    The Department's groundwater staff stated that pyridaben is stable under hydrolysis at pH's 5, 7 and 9. Aqueous photolysis is a major degradation route, with a calculated half-life of 5.3 minutes. Three major degradates were found; an unidentified degradate reached 16% of applied radioactivity after 30 minutes, then decreased to 2% after two hours. Another unidentified degradate reached 28% at 40 minutes, then decreased to <=10% after two hours. The degradate B-3 reached approximately 20% of the applied radioactivity at 30 minutes, and increased to 27% after six hours. Because this is a foliar application that works by contact, aqueous photolysis is not expected to be a major component of degradation. B-3 was not looked for in the field dissipation studies, probably because aqueous photolysis was not a major degradate mechanism in the field studies. Soil photolysis had a calculated half-life of 11 days with no major degradates.

    The aerobic metabolism half-life was 86 days in sandy loam, and the anaerobic metabolism was almost non-existent. The study started out under aerobic conditions, and gradually reached anaerobic conditions in a nitrogen atmosphere. There were many minor degradates as the study started, and degradation ceased as the study reached anaerobic conditions. The adsorption-desorption study indicated that the parent material has a Koc of 34,900 in sand, sandy loam, two silt loams and a clay loam soil. During the aged leaching study, the parent was found to be slightly mobile, but the degradate P-14 (found at 7%) was shown to leach (9-14 is a degradate of the degradate P-1). A separate adsorption-desorption study was made available for this degradate, indicating that the Koc for sand is 54.9 and for sandy loam is 14.8. The terrestrial field dissipation studies generally confirmed the laboratory data, with first-order half-lives ranging from eight to 14 days. Only trace levels of PB-14 were found in the 0-6" soil column (<=2, 85% of applied). Even though PB-14 was found to be very mobile, the concentrations found were low enough that the USEPA did not believe the degradate would have an impact on groundwater.

    Modeling was conducted using sandy Riverhead soil type and an 86-day half-life, and the Koc's listed above. The parent pyridaben was not projected to leach at all. For P-14 a value of 31.7 ppb was projected which approaches the drinking water standard set for pyridaben of 35 ppb. The model was run using two applications at the maximum application rate (0.05 lb. active ingredient/acre) 90 days apart, and assumes that the entire application is applied to bare ground. Given foliar interception, the impact to groundwater from the degradate P-14 would be negligible. However, grapes are considered a major crop in our State and are grown extensively on Long Island. The ground between grape arbors is usually bare and it is possible for product to reach the bare ground during application.

    Long Island has a vulnerable sole-source drinking-water aquifer and the Department has concerns regarding the potential for groundwater contamination as a result of the addition of grapes to the Pyramite Miticide/Insecticide label. The label contains the following statement: "Pyramite is not for sale, distribution, or use in Nassau and Suffolk counties in New York State. In the remainder of the state, read and follow all applicable directions, restrictions and precautions on this label."

    Since this product is not for use in Nassau and Suffolk Counties, this product when used as labeled, is not expected to impact the groundwater in New York State.

    Therefore, the Department hereby accepts for general use registration in New York State the major change in labeling for Pyramite Miticide/Insecticide (EPA Reg. No. 7969-125).

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

    If you have any questions, please contact Ms. Jeanine Broughel, of my staff, 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