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Emamectin Benzoate - Registration of Proclaim Insecticide 3/00



New York State Department of Environmental Conservation
Division of Solid & Hazardous Materials
50 Wolf Road, Albany, New York 12233-7254
Phone: (518) 457-6934 FAX: (518) 457-0629


March 23, 2000

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

Mr. Jerry Harrison

Manager, State Registration and Regulatory Support
Novartis Crop Protection, Inc.
PO Box 18300
Greensboro, NC 27419-8300

Dear Mr. Harrison:

Re: Application for Registration of One New Pesticide Product, Proclaim Insecticide (EPA Reg. No. 100-904), Which Contains the New Active Ingredient Emamectin Benzoate

    The New York State Department of Environmental Conservation (the Department) has completed the review of your application, received June 3, 1999, and additional information, received August 10, 1999, to register one new pesticide product, Proclaim Insecticide (EPA Reg. No. 100-904) in New York State. The product contains the new active ingredient emamectin benzoate. The application was deemed complete on September 21, 1999 and a registration decision is due by April 1, 2000.

    A registration decision would be due to Novartis Crop Protection, Inc. for Proclaim Insecticide by February 18, 2000 (150 days from the date of completeness). However, Novartis Crop Protection, Inc. had requested that the Department review the registration application for FLINT and Compass before two other pending non-routine Novartis registration applications, Proclaim Insecticide and Action Herbicide.

    Novartis Crop Protection, Inc. has agreed to the following revised registration decision schedule:

PRODUCT name REGISTRATION DECISION DATE
FLINT (EPA Reg. No. 100-919) and
Compass (EPA Reg. No. 100-920)
March 1, 2000
Proclaim Insecticide (EPA Reg. No. 100-904) April 1, 2000
Action Herbicide (EPA Reg. No. 100-806) July 1, 2000

    Proclaim is labeled for control of certain lepidopteran pests on head and stem Brassica vegetables, celery, and head lettuce.

    The maximum application rate is 4.8 ounces of product per acre per application and 28.8 ounces of product per acre per season or 0.015 pounds emamectin benzoate per acre per application and 0.09 pounds emamectin benzoate per acre per season.

    The Department has reviewed the information supplied to date in support of the application for registration of Proclaim Insecticide (EPA Reg. No. 100-904).

    Neither technical emamectin benzoate nor the formulated Proclaim Insecticide product was very toxic in acute dermal or inhalation exposure studies in laboratory animals, nor were they dermal sensitizers or very irritating to the skin (the formulated product used in the acute inhalation and dermal sensitization studies contained 2.1 percent active ingredient instead of the 5.0 percent contained in the Proclaim product). Technical emamectin benzoate demonstrated moderate acute oral toxicity and was a severe eye irritant to rabbit eyes, but the formulated product was a mild eye irritant and was not very toxic in acute oral exposure studies in laboratory animals.

    The United States Environmental Protection Agency (USEPA) calculated an oral reference dose (RfD) for emamectin benzoate of 0.00025 milligrams per kilogram per day (mg/kg/day) based on the no-observed-effect level (NOEL) from the subchronic neurotoxicity in mice (0.075 mg/kg/day) and an uncertainty factor of 300. This value has not yet been adopted by the USEPA's Integrated Risk Information System.

    Emamectin benzoate did not cause oncogenic effects in either the rat or mouse studies. It also was negative in a number of genotoxicity tests. The USEPA classified emamectin benzoate as "not likely" to be a human carcinogen.

    The registrant conducted an analysis of occupational exposures from the use of Proclaim on crops. The analysis considered both acute and chronic exposures of mixer/loader/applicators wearing long pants, long-sleeved shirt and gloves (gloves not worn during the application phase). The estimated absorbed (a dermal absorption value of two percent from a study in Rhesus monkeys was used) daily doses of emamectin benzoate were 1.1 x 10-5 mg/kg/day and 2.3 x 10-6 mg/kg/day for acute and chronic exposures respectively. Comparing the estimated acute exposure to the NOEL from the 15-day mouse neurotoxicity study (0.075 mg/kg/day) yields a margin-of-exposure (MOE) of about 6,800. Comparing the estimated chronic exposure to the NOEL from the chronic dog study (0.25 mg/kg/day) yields an MOE of about 110,000. Generally, the USEPA considers MOEs of 100-fold or greater to provide adequate protection.

    The USEPA established tolerances for emamectin benzoate residues in or on head and stem Brassica vegetables, celery and head lettuce each at 0.025 parts per million (ppm). The USEPA estimated that chronic dietary exposure to these residues would be no more than five percent of the population adjusted dose (PAD) for infants and children and no more than four percent of the RfD for adults. This chronic exposure analysis is based on the assumption that 25 percent of crops are treated and contain tolerance level residues. An acute dietary risk assessment estimated that exposures would occupy 8%, 65% and 27% of the PAD for infants, children and females 13 years and older, respectively.

    There are no chemical specific federal or State drinking water standards for emamectin benzoate. Based on its chemical structure, emamectin benzoate falls under the 50 microgram per liter (μg/L) general New York State drinking water standard for "unspecified organic contaminants" (10 NYCRR Part 5, Public Water Systems). Based on the USEPA Office of Pesticide Programs RfD of 0.00025 mg/kg/day and the Department of Environmental Conservation Water Quality Regulation procedures for deriving surface water and groundwater standards and guidance values from non-oncogenic effects (6 NYCRR - Part 702.5), an ambient water quality value for emamectin benzoate would be 1.8 μg/L.

    Emamectin benzoate demonstrated a moderate acute oral toxicity and also caused neurotoxic and developmental effects in laboratory animals at relatively low doses. This active ingredient, however, did not cause oncogenic effects in rat or mouse studies, and also was negative in a number of genotoxicity tests. Due to its low application rate and the limited crops to which it is applied, the labeled use of Proclaim Insecticide does not appear to pose significant risks to the general public from dietary exposure or to workers. In view of the above, the Department does not object to the registration of this product as a "restricted use pesticide" in New York State. However, if the registrant submits an application for significant additional crop use, acute dietary risks could be raised to unacceptable levels and may be a registration issue.

    Emamectin benzoate is highly toxic to marine/estuarine crustaceans. The leaching/adsorption/desorption studies show that depending upon the type of soil, 0.1 - 0.82% of the applied material can be desorbed. The modeling found marine/estuarine impacts even when as little as 0.25% of the applied active ingredient was allowed to be displaced by runoff.

    The label does require a 25 foot vegetated buffer strip, and also prohibits application of Proclaim within 25 feet of a water body. The Department recognizes that buffer strips serve to reduce the potential for pesticides to be displaced off a treated field. However, the efficacy of the buffer strip will depend on how well it is maintained. Because buffer strip maintenance is not an enforceable requirement for a pesticide label, the mitigative potential for buffer strips is limited.

    Modeling shows that problems with emamectin benzoate only occur after four to six multiple applications with only a seven-day interval between applications. However, the label also contains the requirement:
"Do not make more than two sequential applications for worm control without rotating to another worm control product with a different mode of action."
The purpose of this restriction is to limit the potential for resistance to emamectin benzoate building up in target worm population. However, assuming that an alternate worm control treatment would take at least two to three weeks, it can be anticipated that two sequential Proclaim applications would be separated by at least a two-week interval before an additional series of Proclaim applications. A two-week interval between two-application Proclaim treatments would allow the emamectin benzoate sufficient time to degrade before the next series of applications. Because Proclaim is a "restricted use pesticide," it can be expected that a certified applicator would read, understand, and observe the restriction regarding the limit of two sequential applications.

    The emamectin benzoate degradation that will occur during the time an alternative worm treatment product is used, coupled with the buffer strip requirement should adequately mitigate the potential risk to marine/estuarine invertebrates. Used as labeled, Proclaim should not present unacceptable risk to birds, mammals, fish, freshwater or marine/estuarine invertebrates.

    Emamectin benzoate is poorly soluble in water. The hydrolysis half-life of emamectin benzoate is 19.5 weeks at pH 9 and stable at pHs 5.2, 6.2, 7.2 and 8.2. Emamectin benzoate degraded on microbially active soil with a photolysis half-life of five days, degraded in natural water with an aqueous photolysis half-life of 3.6 days in summer sunlight, and 6.9 days in fall sunlight.

    Emamectin benzoate degrades in a kinetic phase with a half-life, which includes aerobic and anaerobic metabolism, of 174.2 days. The anaerobic half-life is 427.4 days. Emamectin benzoate exhibits no mobility. The kocs range from 25,000 to 728,000. Terrestrial field dissipation studies indicate a maximum half-life of 15-17 days. No quantifiable residues were found at 6-12 inches, and no detectable residues were found below 12 inches.

    Given the very low application rate, the short half-life for photolysis, the very high kocs and the results of the terrestrial field dissipation studies, it appears that this product will not impact groundwater in New York State when used according to label directions.

    The labeled uses of Proclaim Insecticide do not appear to pose a significant risk to workers or the general public. No adverse effects to groundwater/surface water, birds, mammals, fish, freshwater or marine/estuarine invertebrates are anticipated through normal use of Proclaim Insecticide.

    Therefore, the Department hereby accepts for registration Proclaim Insecticide (EPA Reg. No. 100-904). The product is classified as a "RESTRICTED USE PESTICIDE" by the USEPA and is, therefore, classified as restricted use in New York State in accordance with rules and regulations 6 NYCRR 326.2 (copy enclosed).

    As such the product is restricted in its purchase, distribution, sale, use, and possession in New York State. Furthermore, the product may only be purchased and used by a certified applicator 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 concerning commercial permits, please contact the Pesticide Certification Section, at (518) 457-7482.

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

    Please be aware that if New York State registration is requested for this or any other product which contains emamectin benzoate with expanded use sites and/or a higher application rate, 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 Maureen P. Serafini, Chief of our Pesticide Product Registration Section, at (518) 457-7446.

Sincerely,

Stephen Hammond, P.E.
Director
Division of Solid & Hazardous Materials

Enclosures

cc: w/enc. - N. Kim/D. Luttinger - NYS Dept. of Health
J. Leach/J. Kaplan - NYS Dept. of Health
R. Zimmerman/ R. Mungari - NYS Dept. of Ag. & Markets
G. Good/W. Smith - Cornell University, PMEP

JMB:scy
(jeanine\PROCLAIM.REG)

Mr. Jerry Harrison