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methoxyfenozide Pesticide Tolerances 10/01

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

						May 10, 2004


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 One New Pesticide Product, Intrepid 2F (EPA Reg. 
		No. 62719-442), Which Contains the New Active Ingredient 

	The New York State Department of Environmental Conservation (Department) has reviewed 
your application, received October 29, 2002, and additional information, received March 13, 
2003, August 6, 2003, September 25, 2003, April 20, 2004 and May 7, 2004, to register one new 
pesticide product, Intrepid 2F (EPA Reg. No. 62719-442), in New York State.  The product 
contains the new active ingredient methoxyfenozide (chemical code 121027).

	The application was deemed complete for purposes of review on April 22, 2003 and the 
legislatively mandated registration decision date was September 19, 2003.  Dow AgroSciences 
LLC 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 Intrepid 2F in New York State.

	Intrepid 2F Agricultural Insecticide (EPA Reg. No. 62719-442) belongs to the 
diacylhydrazine class of insecticides and has a novel mode of action that mimics the 
action of the molting hormone of Lepidopterous (moths, butterflies) larvae.

	Intrepid 2F has virtually no effect on any order of insects or Arthropods except the 
Lepidoptera, making it an ideal tool for Integrated Pest Management.  However, the label 
contains the following statements in the "Environmental Hazards" section:

"Drift and runoff from applications of this product may be hazardous to sensitive aquatic 
invertebrates in water bodies adjacent to the treatment area."

"This chemical has properties and characteristics associated with chemicals detected in 
groundwater.  The use of this chemical in areas where soils are permeable, particularly 
where the water table is shallow, may result in groundwater contamination."

 "Methoxyfenozide can contaminate surface water through spray drift.  Under some conditions, 
methoxyfenozide may also have a high potential for runoff into surface water (primarily via 
dissolution in runoff water), for several months post-application.  These include poorly 
draining or wet soils with readily visible slopes toward adjacent surface waters, frequently 
flooded areas, areas over-laying extremely shallow groundwater, areas with in-field canals 
or ditches that drain to overlaying tile drainage systems that drain to surface water.

Do not cultivate within 10 feet of aquatic areas to allow growth of a vegetative filter 

Do not apply by ground within 25 feet, or by air within 150 feet of lakes, reservoirs, 
rivers, permanent streams, marshes, or natural ponds; estuaries and commercial fish farm 

	The list of crops covered by EPA labeling for Intrepid 2F is cotton, pome fruit, globe 
artichoke, lychee, cole crops and leafy vegetables, okra, sweet and field corn, fruiting 
vegetables, stone fruit, cranberry, grapes, and tree nuts and pistachios.  The EPA granted 
Reduced Risk status for methoxyfenozide for the following crops:  pome fruit, cotton, 
grapes and fruiting vegetables, leafy and cole crop vegetables, sweet and field corn, and 
stone fruit.

	The following is the list of crops and application rates taken from the base label 
(cotton and pome fruit) and eleven supplemental labels submitted with this application:

Pome Fruit
0.09 to 0.25 lb. AI /acre
1.0 lb. Methoxyfenozide/acre
0.06 to 0.38 lb. AI/acre
1.0 lb. Methoxyfenozide/acre
Corn (field, sweet, seed)
0.06 to 0.25 lb. AI/acre
1.0 lb. Methoxyfenozide/acre
Cole Crops and Leafy Vegetables
0.06 to 0.25 lb. AI/acre
1.0 lb. Methoxyfenozide/acre
Fruiting Vegetables
0.06 to 0.25 lb. AI/acre
1.0 lb. Methoxyfenozide/acre
Tree Nuts and Pistachios:
0.06 to 0.38 lb. AI/acre
1.0 lb. Methoxyfenozide/acre
0.06 to 0.25 lb. AI/acre
0.75 lb. Methoxyfenozide/acre
Globe Artichoke:
0.06 to 0.25 lb. AI/acre
1.0 lb. Methoxyfenozide/acre
Stone Fruit
0.16 to 0.25 lb. AI/acre
1.0 lb. Methoxyfenozide/acre
Lychee, Longan, Spanish Lime, Rambutan, and Pulasan:
0.19 to 0.25 lb. AI/acre
1.0 lb. Methoxyfenozide/acre
0.16 to 0.25 lb. AI/acre
1.0 lb. Methoxyfenozide/acre
0.06 to 0.25 lb. AI/acre
1.0 lb. Methoxyfenozide/acre
The Department has reviewed the information supplied to date in support of registration of the new product Intrepid 2F (EPA Reg. No. 62719-442). HEALTH EFFECTS: The New York State Department of Health (DOH) stated that neither methoxyfenozide nor Intrepid 2F was very toxic in acute oral, dermal or inhalation exposure studies in laboratory animals, nor were they very irritating to the eyes or skin (tested on rabbits). Neither the active ingredient nor the formulated product was a dermal sensitizer (tested on guinea pigs). Methoxyfenozide caused some toxicity in chronic animal feeding studies. In a chronic feeding/oncogenicity study in rats, methoxyfenozide caused hematological effects (decrease in red blood cell counts and hemoglobin concentrations) in males and females, liver toxicity (increase in liver weights in males and periportal hepatocellular hypertrophy in males and females), histopathological changes in the thyroid of males and increased adrenal gland weights in males and females. These toxicity effects occurred at dose levels of 411 and 491 milligrams per kilogram body weight per day (mg/kg/day) for males and females, respectively; the respective no-observed-effect levels (NOELs) were 10.2 and 11.9 mg/kg/day. In dogs, decreased hematocrit, hemoglobin and red blood cells, methemoglobinemia and bilirubinuria were reported at 106 and 111 mg/kg/day in males and females, respectively; the respective NOELs were 9.8 and 12.6 mg/kg/day. The United States Environmental Protection Agency (USEPA), Office of Pesticide Programs established a reference dose (RfD) of 0.10 mg/kg/day based on a NOEL of 10.2 mg/kg/day in the chronic feeding/oncogenicity study in rats and an uncertainty factor of 100. This same value was used as a Chronic Population Adjusted Dose (cPAD) for evaluating dietary risks. The RfD has not yet been adopted by the USEPA's Integrated Risk Information System (IRIS). Methoxyfenozide did not cause effects in developmental toxicity studies conducted on both pregnant rats and rabbits at the highest dose tested (1,000 mg/kg/day). In addition, no maternal toxicity was demonstrated at this dose. In a two-generation reproduction study in rats, no reproductive effects were observed at the highest doses tested, which were 1,552 and 1,821 mg/kg/day for males and females, respectively. However, parental toxicity characterized by increased liver weights and periportal hepatocellular hypertrophy occurred at these highest doses; the respective NOELs were 153 and 181 mg/kg/day. Methoxyfenozide did not cause oncogenic effects in either rat or mouse chronic feeding studies. This active ingredient was negative in a number of genotoxicity studies. The USEPA classified methoxyfenozide as "not likely" to be carcinogenic to humans. The USEPA established tolerances for methoxyfenozide residues in or on pome fruit at 1.5 parts per million (ppm); stone fruit (3.0 ppm); field corn and sweet corn grain, each at (0.05 ppm); fruiting vegetables (2.0 ppm); leafy vegetables (25 ppm); grapes (1.0 ppm); pistachio (0.1 ppm); lychee (2.0 ppm); tree nuts (0.1 ppm) and cotton (2.0 ppm). The USEPA estimated that chronic dietary exposure to methoxyfenozide residues would be less than 18.7 percent of the cPAD of 0.1 mg/kg/day for the general U.S. population, less than 20.3 percent for infants less than one-year old and less than 34.3 percent for children one to six years old. This chronic exposure analysis is based on the conservative assumptions that 100 percent of crops are treated and contain tolerance level residues. The USEPA did not conduct an occupational risk assessment for exposure to methoxyfenozide since no dermal or systemic toxicity was observed at the highest dose tested (1,000 mg/kg/day) in a 28-day dermal toxicity study in rats. Furthermore, based on the labeled uses of methoxyfenozide, no chronic dermal or inhalation exposure to this active ingredient is expected. In addition, methoxyfenozide was not very acutely toxic by the dermal or inhalation routes of exposure and did not cause developmental effects in rats or rabbits. There are no chemical-specific federal or State drinking water/groundwater standards for methoxyfenozide. Based on its chemical structure, this compound falls under the 50 microgram per liter New York State drinking water standard for an "unspecified organic contaminant" (10 NYCRR Part 5, Public Water Systems). The available information on methoxyfenozide and Intrepid 2F indicates that they were not very acutely toxic, irritating or sensitizing in laboratory animal studies. Methoxyfenozide also did not cause reproductive/developmental effects, nor was it oncogenic or genotoxic. Although data from chronic studies on methoxyfenozide indicated that this chemical has the potential to cause certain hematological and other effects, the expected exposure from the labeled use of Intrepid 2F should not pose a significant risk to the general public or to workers. ECOLOGICAL EFFECTS: The Department's Division of Fish, Wildlife & Marine Resources' Bureau of Habitat (BOH) reviewed the information submitted in support of registration of Intrepid 2F and objects to its registration as Federally labeled. The BOH stated that methoxyfenozide is a new diacylhydrazine insect growth regulator (IGR) that interferes with binding of the molting hormone 20-hydroxyecdysone to its receptor. After ingesting methoxyfenozide larvae stop feeding and undergo a premature lethal molt. Technical methoxyfenozide has a water solubility of 3.3 mg/L. It has low vapor pressure, 2 x10-7 mm Hg, volatilization will not contribute measurably to dissipation. With the relatively low octanol/water partition coefficient, KOW, of 5248 it should not bioaccumulate to a great extent. A bluegill sunfish accumulation study yielded bioconcentration factors of 1.1-1.3 X, 1.6-22.1 X, and 9.9-10.5 X, for fillet, viscera, and whole fish respectively. Depuration was relatively rapid reaching 82-93% by 14 days after exposure cessation. Methoxyfenozide soil organic carbon/water soil partition coefficients, KOC, for 5 soils ranged from 219 to 922 L/Kg with a mean of 422, indicating the potential for moderate post-application mobility. Methoxyfenozide is practically non-toxic to birds and mammals on an acute basis and also has low toxicity with chronic exposures. Chronic high-dose exposure in mammals produces hematological, liver, and thyroid effects. Similar avian exposures resulted in increased food consumption and hatchling weight in Mallard ducks, and decreased eggshell thickness in Bobwhite quail. It is moderately toxic to all aquatic organisms for which acute toxicity study results were submitted and can be highly toxic to aquatic invertebrates with chronic exposure. Methoxyfenozide is a highly persistent chemical. It is stable to hydrolysis and both soil surface and aqueous photolysis. It degrades very slowly via microbial metabolism. Laboratory aerobic soil metabolism half-lives, T1/2, ranged from 573 to 1100 days with a mean of 625 days. Aerobic aquatic T1/2s conducted with soil/water systems from California and Texas were 86 and 963 days respectively. The reported anaerobic aquatic metabolism T1/2 is 654 days. Terrestrial field dissipation studies conducted in Texas, California, Georgia, and Washington yielded registrant calculated T1/2s of 92, 139, 151, and 327 days respectively. All of the laboratory metabolism and field dissipation studies were classified supplemental by USEPA reviewers and all likely underestimate the actual respective T1/2s. The most common flaw in the studies was insufficient soil extraction of methoxyfenozide which would leave undegraded parent compound unaccounted for. Additionally, in the field dissipation studies no analysis of metabolites was performed. In aerobic soil metabolism studies the predominant metabolite detected was RH131154 which was present at a maximum of 1-3% of applied parent. In aerobic aquatic studies the predominant metabolite was RH117236 which reached a maximum of 6.7% of applied in one study and 15.8% in another. Both of these metabolites retain the core structure of the parent molecule. The metabolites differ from the parent by the alteration of one peripheral functional group in each case. It is unknown if the toxicity or fate of the metabolites has been investigated, no data was submitted, but being as structurally similar to the parent molecule as they are, suggests they may have similar biological activity. Screening modeling was conducted to estimate terrestrial and aquatic non-target organism exposures. Terrestrial vegetation residue estimates were calculated for six food categories following application of the seasonal maximum rate. Aquatic methoxyfenozide concentrations resulting from transport in runoff to surface waters was estimated for a series of application and runoff rates. Results were generated assuming a 50% target plant interception rate, 1.5% of applied material being transported in solution (the middle rate for a chemical with this KOW) and 100% of the runoff water reaching the model pond. No avian or mammalian toxicity thresholds were exceeded by vegetation residues. An aquatic non-target toxicity threshold, midge NOEC, is exceeded with the first application of the first year of use in the 1-foot pond depth. Additional applications result in increasing water concentrations and more exceeded thresholds. Methoxyfenozide is a very persistent compound that is likely to be transported in solution to surface waters and leach to groundwater. Despite the registrant's description of this active ingredient as being lepidopteran specific, the mysid shrimp, Daphnia, and fathead minnow life-cycle studies with LOECs ranging from 0.051 to 1.0 mg/L, and the results of the 6(a)(2) mosquito, midge, and microcosm studies suggest otherwise. Acute adverse effects to terrestrial vertebrates are not anticipated. However, in the most recent USEPA evaluation submitted to BOH, an April 2001 assessment of Intrepid 2F use on corn, the EPA EFED required an additional Avian Reproduction study to re-examine the egg shell effect noted in the original Bobwhite quail study. Because of methoxyfenozide's ability to bind to a hormone receptor and affect the development of insects it can be classified as an endocrine disruptor. Whether the effects noted in non-target organisms is a result of the endocrine disrupting mode of action is unknown. Given the persistence and mobility of methoxyfenozide, a broad range of organisms could be affected by its proposed use patterns, any adverse impacts would be very slow to reverse. Given the above, the BOH objects to the registration of Intrepid 2F in New York State as Federally labeled. ENVIRONMENTAL FATE AND GROUNDWATER IMPACTS: The Department's groundwater staff stated that Intrepid is a liquid that is mixed with water and foliarly applied using various types of sprayers. Intrepid contains 22.6% by weight active ingredient, or 2 lb/gal ai. The maximum application rate is 64 fluid ounces of product per acre per year or 1 lb ai/a/yr, depending on crop type, applied at a maximum of 0.06 to 0.38 lb ai/a per application. None of the inerts appear to be solvent carriers. Hydrolysis: Methoxyfenozide is stable to hydrolysis, according to the June 9, 2000 USEPA Decision Memorandum. Solubility: Methoxyfenozide has a solubility of 3.3 mg/L according to the April 2, 2001 USEPA memorandum. Aqueous Photolysis: Methoxyfenozide is stable to aqueous photolysis, according to the June 9, 2000 EPA Decision Memorandum. Soil Photolysis: Methoxyfenozide is stable to soil photolysis, according to the June 9, 2000 EPA Decision Memorandum. Aerobic Soil Metabolism: Three aerobic metabolism studies were reported. In two studies, one in a loam soil (from Visalia, CA) and one in a loamy sand (from Ohio), the half-life was of questionable validity because it was determined beyond the scope of the observed data. In a third study, USEPA found it scientifically valid, but only supplemental because it did not fulfill Subdivision N Guidelines. In a loamy sand (from Georgia) and a sandy clay loam (from Texas), the registrant-calculated half-lives of 336 and 722 days respectively. However, USEPA had many concerns about the way the study was conducted, and felt that the half-life from Georgia may have been underestimated. The USEPA reported half-life ranged from 336 to 1100 days. Aerobic Aquatic Metabolism: USEPA found this study scientific valid and providing useful information on the aerobic aquatic metabolism of methoxyfenozide in sandy loam and clay soil/water systems. However, the half-life was beyond the scope of the data for the sandy loam soil/water systems, and the parent was observed to be stable in the sandy loam soil/water system from 60 to 365 days post treatment and in the clay soil/water system from 120 to 365 days. The USEPA reported half-life ranged from 387-962 days. Anaerobic Aquatic Metabolism: USEPA found this study scientifically valid, but it did not meet Subdivision N guidelines. The parent is essentially stable with a registrant-calculated half-life of 654 days. The majority of the "degradation" was due to parent compound leaving the aqueous phase and associating with the soil. The USEPA reported half-life was 654 days. Adsorption/Desorption: USEPA found this study scientifically valid, but it did not meet Subdivision N guidelines because the five soils were too finely sieved, so that a significant portion of the sand fraction may have been removed. However, USEPA did not require the study to be repeated, because the addition of more sand would only make the materials' Kocs lower, or more mobile. Kocs were 267 in a sandy loam, 922 in a loam, 678 in a silt loam, 219 in a loamy sand, and 365 in a second loamy sand. Desorption Kocs were 680 in a sandy loam, 1598 in a loam, 1390 in a silt loam, 288 in a loamy sand, and 433 in a second loamy sand. Field Dissipation: USEPA found this study to be supplemental and upgradable. Methoxyfenozide was broadcast five times at 12-16 day intervals at a nominal rate of 0.5 lb ai/a/application to bare ground plots of loamy sand soil, sand soil and sandy clay loam soil. The registrant calculated half-lives were 139, 151 and 92 days, respectively. Parent was present in 0-6, 6-12 and 12-18 inch depths, at up to 0.029 ppm at 543 days. Parent was present at LOD and LOQ at 18-24 inches at times as early as 126 days post treatment. USEPA found a second study to be supplemental. Methoxyfenozide was broadcast five times at a nominal rate of 0.5 lb ai/a/application to bare ground plots of a sand soil. The registrant calculated half-life was 327 days. Dissipation was found to be biphasic with slower dissipation occurring from 90 to 309 days post treatment. Parent was present down to 36 inches, at up to 0.16 ppm at 309 days. Samples were not collected below 36 inches. USEPA Comments: Methoxyfenozide is very persistent and moderately mobile and has the potential to accumulate in the environment following repeated applications. However, methoxyfenozide does not bioaccumulate. The compound is stable to hydrolysis and photolysis. It degrades very slowly under both aerobic and anaerobic conditions. Aerobic soil metabolism data demonstrate half lives ranging from 336 to 1100 days. Aerobic aquatic metabolism data shows half lives of 387 and 962 days. Under anaerobic aquatic conditions methoxyfenozide has a half-life of 654 days. These half-lives reflect not only metabolic processes, but likely include losses due to unextracted methoxyfenozide. The actual metabolic half-life may be higher. Terrestrial field dissipation data show that methoxyfenozide leaches when applied to fields with half-lives ranging from 92 to 327 days. Terrestrial field dissipation half-lives are considerably shorter than the laboratory-derived aerobic soil half-lives. Possible reasons for the differences include loss of methoxyfenozide due to runoff and leaching below the deepest detection point, apparent loss of methoxyfenozide due to incomplete extraction from field cores, as well as the possibility that more viable microbial populations exist in field soils such that degradation in the field could be greater than degradation in the lab. Given the compound's mobility, methoxyfenozide may have the potential to move offsite by runoff and leaching, as well as by spray drift. It may contaminate both surface and ground water at or near sites of application and, due to its persistence, could accumulate to significant levels in water and benthic sediments. Computer Modeling: Modeling by the Department on Riverhead sand, using 1.0 lb ai/a/yr, a Koc of 680, and an aerobic half-life of 336 days projected breakthrough in the second year, accumulating to 1.5 ppb at the end of ten years. Changing to the worst case parameters of a Koc of 267, and an aerobic half-life of 1100 days the model projected breakthrough for the parent in the second year, accumulating to about 85 ppb at the end of ten years. Summary: This active ingredient has a range of Kocs and aerobic metabolism half-lives, and modeling the best case scenario indicates the accumulation of leachate, reaching about 1.5 ppb in the ten year model projection. Modeling the worst case scenario predicts leachate accumulating to about 85 ppb. The USEPA conditionally registered this product, with no end date. The USEPA memorandum dated January 4, 2000 indicates that a Prospective Groundwater Monitoring Study should be performed, but this was not mentioned in the Notice of Registration. USEPA has also indicated that this active ingredient is moderately persistent and mobile. While this is a reduced-risk active ingredient that replaces some OP products, staff are hesitant to recommend use on Long Island. Therefore, staff have no objections to the registration of this product, provided a Long Island prohibition is placed on the label. The Department reviewed all information submitted in support of registration of Intrepid 2F in New York State and still has unresolved concerns regarding the potential of methoxyfenozide to impact groundwater and the fish and wildlife resources in New York State when used according to the Federally accepted label. The Department has received numerous letters which expressed support of the product and the need for the immediate use of Intrepid 2F on apples, particularly for the control of Codling Moth and Oriental Fruit Moth. Growers in western New York have experienced a severe and growing problem with internal worms in apples from primarily Codling Moth and Oriental Fruit Moth. Previously, these worms were controlled by the large amounts of chlorpyrifos used to try to control Obliquebanded Leafroller. Currently, tebufenozide and spinosad are controlling the obliques and these formerly secondary pests are becoming serious primary pests. In the 2001 crop year, Motts rejected 17 loads of apples from 8 growers. In the 2002 season, they rejected 133 loads from 28 growers. In addition to protecting the processing market, growers are very concerned about the fresh export market, particularly to the United Kingdom (UK). If worms are found in New York State apples, the entire fresh export market would be closed down immediately. The loss of the UK market would be a huge loss to the New York apple industry and would result in a big reduction in domestic Empire apple prices. The Department is aware of the importance of the apple industry in New York State and the need for adequate control of various lepidopteran larvae, including Codling Moth and Oriental Fruit Moth larvae. Apples are grown on approximately 55,000 acres and are a major crop in New York State. New York is ranked second, behind Washington State, in the production of apples. Dow AgroSciences LLC, on April 9, 2004, submitted paperwork to the USEPA for the addition of the following New York State specific label language to their federally accepted Intrepid 2F product label: Not for Sale, Use, or Distribution in Nassau County and Suffolk County in New York State. The addition of the phrase "Not registered in New York" to all uses except pome fruit. The Department concludes that Intrepid 2F should not have an adverse effect on the health of workers or the general public, the fish and wildlife resources, or the ground and surface water of New York State when used as a foliar spray, on apples and other pome fruit only, in accordance with New York State specific label language. Therefore, the Department hereby accepts for restricted use registration in New York State the new active ingredient application of Intrepid 2F (EPA Reg. No. 62719-442) with the final printed labeling containing the New York State specific language. Intrepid 2F 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. 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 or contact the Pesticide Reporting Section at (518) 402-8765. Enclosed are your New York State stamped "ACCEPTED" label and a copy of the Certificate of Registration. Dow AgroSciences LLC is reminded that if New York State registration is requested for this product or for any other product which contains methoxyfenozide 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. If you have any questions, please contact Mr. Samuel Jackling, Chief of our Pesticide Product Registration Section, at (518) 402-8768. Sincerely, MPS 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