United States Office of Prevention, Pesticides and Toxic Environmental Protection Agency Substances (7505P) e CDA Pesticide Fact Sheet Name of Chemical: Flubendiamide Reason for Issuance: Conditional Registration Date Issued: August 1, 2008 DESCRIPTION OF CHEMICAL Generic Name: N2-[ 1,1 -Dimethyl^-CmethylsulfonyOethylJ-B-iodo-N1 -[2-methyl- 4-[l ,2,2,2-tetrafluoro-l -(trifluoromethyl)ethyl]phenyl]-l ,2- benzenedicarboxamide Common Name: Flubendiamide EPA Chemical Code: 027602 Chemical Abstracts Service (CAS) Number: 272451 -65-7 Pesticide Type: Insecticide Chemical Type: Phthalic Acid Diamide U.S. Producer: Bayer CropScience LP 2 T.W. Alexander Drive Research Triangle Park, NC 27709-2014 ------- USE PATTERNS AND FORMULATIONS Application Sites: Flubendiamide is registered for use on corn, cotton, tobacco, pome and stone fruit, tree nut crops, grapes and vegetable crops (including cucurbit vegetables, fruiting vegetables and okra, leafy vegetables [except Brassica] and Brassica [cole] leafy vegetables). Types of Formulations: NNI-0001 Technical (manufacturing concentrate) NNI-0001 24 WG Insecticide (water dispersible granule) NNI-0001 480 SC Insecticide (soluble concentrate) Application Methods and Rates: Flubendiamide acts against various lepidopterous insect pests such as armyworms, bollworms, corn borers, cutworms, diamondback moths, fruitworms and loopers. Foliar spray applications can be made by aerial, ground or chemigation application on all crops as needed for insect control. Single application rates range from 0.03 to 0.16 Ib. a.i./A and can be applied 3-5 times per season. Seasonal application rates range from 0.09 to 0.47 Ib. a.i./A. Pre-harvest intervals (PHIs) range from 1 to 28 days. The proposed reentry interval (REI) is 12 hours on both labels. NNI-0001 24 WG Insecticide is a 24% a.i. water dispersible granule. NNI-0001 480 SC Insecticide is a 39% a.i. soluble concentrate. HUMAN HEALTH RISK ASSESSMENT Hazard and risk assessments were conducted in relation to this registration application and tolerance petition for the use of flubendiamide on corn, cotton, tobacco, tree fruit, free nuts, vine crops and vegetable crops and suggest that its use, consistent with the proposed labeling measures, will be protective of the public health and the environment. Acute Toxicity: Flubendiamide has a low order of acute toxicity via the oral, dermal and inhalation routes (Category III). Though it is a slight irritant to the eye, flubendiamide is not a skin irritant and it is not a skin sensitizer. The acute toxicity findings for flubendiamide are summarized below: Acute Oral Toxicity: III Acute Dermal Toxicity: III Acute Inhalation: III Primary Eye Irritation: IV Primary Dermal Irritation: IV Dermal Sensitization: Negative Other Toxicity: In the longer-term studies in the flubendianiide mammalian toxicology database, the primary target organs identified were the liver, thyroid, kidney and eyes. Liver effects reported in rats, mice and/or dogs include organ ------- weight increase, periportal fatty change, hypertrophy, and minimal foci of cellular alteration. Thyroid effects include organ weight increase, follicular cell hypertrophy and slight perturbations of triiodothyronine (T3) and thyroid stimulating hormone (TSH) in the rat and mouse. Kidney effects include increases in absolute and/or relative to body kidney weights and chronic nephropathy in the rat. Eye effects include eye enlargement, opacity, and exophthalmus with hemorrhage and appear only in rat pups. Other changes include mild microcytic anemia, decreased serum triglycerides and cholesterol in female rat, increased gamma glutamyl peptidase, alkaline phosphatase and shortened activated prothrombin time in dogs and adrenal weight increase and increase in adrenal cortical cell hypertrophy in dogs. The hazard assessment indicated potential toxicity resulting from exposure to flubendiamide via different routes over different durations. The observed eye effects were selected as a critical effect for the acute dietary exposure scenario; whereas liver and thyroid effects were determined critical for the chronic dietary exposure scenario. Short- and intermediate-term dermal risks were also based on liver and thyroid effects, as well as blood effects. Short- and intermediate-term inhalation risks are based on liver toxicity, as well as adrenal weight increase and an increase in adrenal cortical cell hypertrophy. Metabolism: Rat metabolism studies at low and high doses report fairly rapid absorption, with peak blood and plasma levels reached at approximately 6 to 12 hours post-dosing followed by a continuous decline. The NNI-0001 was fairly well distributed among blood and most of the organs and tissues, with some preference to the liver, adrenal glands, and fat. Generally, the liver and kidneys contained the greatest percentage of the administered dose. Excretion of NNI-0001 residues was rapid (majority of radioactivity recovered at the first 24-hour collection point), with feces being the predominant route of excretion. Renal excretion accounted for only 2% and <1% of the dose in male and female rats, respectively. Parent NNI-0001, NNI-0001 -benzylalcohol (A-16) and NNI-0001-benzoic acid (A-18) were the major residues identified in the feces. Additionally, metabolite A-14 was identified in the fat of female rats at 1% of the administered dose. In vitro metabolism and toxicokinetic studies in multiple mammalian species appear to confirm the findings reported in the in vivo rat metabolism study, that female rats appear to metabolize the parent compound differently from male rats and other species. Female rats do not show an ability to convert the parent compound to the metabolite A-16 due to the lack of P-NADPH that is required for metabolism, indicating there was no abiotic degradation of the test compound in the test systems. The lack of abiotic degradation and the longer terminal elimination half-life of the parent compound in the female rats, differentiate them from other test animals. Endpoints Acute: The 2-generation reproduction, 1-generation reproduction and DNT studies, as 3 co-critical studies, were selected for the acute reference dose (aRfD) of 0.995 ------- mg/kg/day using 99.5 mg/kg/day from the DNT study (the highest NOAEL) and a LOAEL from the 1-generation reproduction study of 127 mg/kg/day (the lowest LOAEL) based on buphthalmia (enlargement of eyes), ocular opacity, retinal degeneration, hemorrhage, cataract and atrophy of the optic nerve. The NOAEL/LOAEL chosen result in a more refined yet health protective acute dietary risk assessment. The weight of evidence from various studies suggest that the finding of enlarged eyeballs in rat offspring is a rat-specific phenomenon, resulting from exposure to higher steady-state concentrations of flubendiamide which may be due to the uniquely diminished capacity of the female rat to oxidize the parent compound. While human microsomes have been shown to be capable of approximately 4 times higher hydroxylation rates than female mouse microsomes and may be able to efficiently metabolize/excrete flubendiamide, preventing accumulation of the parent compound, it remains unclear whether this ability is the only requirement to avoid ocular toxicity. Due to the potential concern for increased susceptibility of human neonates vs. adults, this perinatal ocular effect is considered in the HED risk assessment. Chronic: The 1-year chronic rat study, 1-year chronic dog study and the 24-month rat carcinogenicity study were selected as 3 co-critical studies for the chronic reference dose (cRfD) of 0.024 mg/kg/day with a NOAEL/LOAEL of 2.4/33.9 mg/kg/day (highest NOAEL of 2.4 mg/kg/day from 1-year chronic rat study and lowest LOAEL of 33.9 mg/kg/day from 24-month rat study. Although the 1-year dog study had NOAELs of 2.21/2.51 mg/kg/day, the lowest NOAELs from each study were considered when comparing NOAELs among the 3 studies, respectively, based on the consistent liver toxicity reported across multiple studies, different durations and multiple species. The NOAEL/LOAEL chosen are protective of effects seen in other long-term studies. Carcinogenicity: Flubendiamide is considered to be "Not Likely to be Carcinogenic to Humans." There was no evidence of carcinogenicity in rats and mice up to the limit dose at 24- and 18-months, respectively. Flubendiamide was determined to be non-mutagenic in bacteria, negative in an in vivo mammalian cytogenetics assay and did not cause unscheduled DNA synthesis (repair of DNA damage) in mammalian cells in vitro. Overall, there was no clear evidence that flubendiamide was either mutagenic or clastogenic in either in vivo or in vitro assays. Quantification of cancer risk is; therefore, not needed for flubendiamide. FQPA Safety Factor: EPA evaluated the quality of the toxicity/exposure data and has determined that the safety of infants and children would be adequately protected if the FQPA safety factor (SF) were reduced to Ix based on the following findings: (1) The toxicology database for flubendiamide is complete for purposes of risk assessment and the characterization of potential pre- and/or post-natal risks to infants and children. Although susceptibility was identified in the toxicological database (eye effects), the selected regulatory PODs (which are based on clear NOAELs) are protective of these effects; therefore, the human health risk assessment is protective; ------- (2) There are no treatment-related neurotoxic findings in the acute neurotoxicity and DNT studies in rats. Although eye effects were observed in the DNT study, the PODs employed in the HED risk assessment are protective of this effect; and (3) There are no residual uncertainties identified in the exposure databases and the exposure assessment is protective. Dietary Exposure Acute Risk: The acute dietary analysis assumed that 100% of crops with requested uses of flubendiamide are treated and that all treated crops contain residues at tolerance-level. In addition, tolerance-level residues for livestock commodities were included in these analyses to account for the potential transfer of plant residues to livestock tissues. Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. For acute dietary risk assessment, the water concentration value of 12.93 ppb was used to assess the contribution to drinking water. These assumptions result in conservative, health-protective estimates of exposure which are well below the Agency's LOG (100% of the aPAD). The maximum exposure estimate is less than 8% of the aPAD for the most highly exposed population subgroup, children 1-2 years old. These analyses indicate that there are no acute dietary exposure considerations that would preclude registration of flubendiamide for the requested uses. Chronic Risk: The chronic dietary analysis assumed that 100% of requested crops are treated and that all treated crops contain residues at the average residue levels found in the crop field trials and experimentally-determined processing factors where available. In addition, average-level residues for livestock commodities were also included in these analyses to account for the potential transfer of plant residues to livestock tissues. Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. For chronic dietary risk assessment, the water concentration value of 11.95 ppb was used to assess the contribution to drinking water. These assumptions result in conservative, health-protective estimates of exposure which are well below the Agency's LOG (100% of the cPAD). The maximum exposure estimate is less than 15% of the cPAD the most highly exposed population subgroup, children 1-2 years old. These analyses indicate that there are no chronic dietary exposure considerations that would preclude registration of flubendiamide for the requested uses. Aggregate Risk: The aggregate risk assessment considers dietary exposures from food and drinking water to flubendiamide consumed over the acute and chronic durations. Acute and chronic dietary exposure is well below the Agency's LOG and there are no acute or chronic dietary exposure considerations that would preclude registration of flubendiamide for the requested uses. Residue Chemistry: The nature of the residue in plants, rotational crops and ruminants is adequately understood. For the purposes of tolerance establishment and ------- dietary/drinking water risk assessment, the residue of concern in plants, animals and rotational crops is the parent flubendiamide/?er se. Tolerances have been established in 40 CFR §180.639 in or on the following food commodities: almond, hulls (9.0 ppm); apple, wet pomace (2.0 ppm); brassica, head and stem, subgroup 5A (0.60 ppm); brassica, leafy greens, subgroup 5B (5.0 ppm); cattle, fat (0.30 ppm); cattle, kidney (0.30 ppm); cattle, liver (0.30 ppm); cattle, muscle (0.05 ppm); corn, field, forage (8.0 ppm); corn, field, grain (0.02 ppm); corn, field, stover (15 ppm); corn, pop, grain (0.02 ppm); corn, pop, stover (15 ppm); corn, sweet, forage (9.0 ppm); corn, sweet, kernel plus cob with husks removed (0.01 ppm); corn, sweet, stover (25 ppm); cotton gin byproducts (60 ppm); cotton, undelinted seed (0.90 ppm); egg (0.01 ppm); fruit, pome, group 11 (0.70 ppm); fruit, stone, group 12 (1.6 ppm); goat, fat (0.30 ppm); goat, kidney (0.30 ppm); goat, liver (0.30 ppm); goat, muscle (0.05 ppm); grain, aspirated fractions (5.0 ppm); grape (1.4 ppm); horse, fat (0.30 ppm); horse, kidney (0.30 ppm); horse, liver (0.30 ppm); horse, muscle (0.05 ppm); milk (0.04 ppm); milk, fat (0.30 ppm); nut, tree, group 14 (0.06 ppm); okra (0.30 ppm); poultry, fat (0.02 ppm); poultry, liver (0.01 ppm); poultry, muscle (0.01 ppm); sheep, fat (0.30 ppm); sheep, kidney (0.30 ppm); sheep, liver (0.30 ppm); sheep, muscle (0.05 ppm); vegetable, cucurbit, group 9 (0.20 ppm); vegetable, fruiting, group 8 (0.60 ppm) and vegetable, leafy, except brassica, group 4(11 ppm); and in or on the following raw agricultural commodities: alfalfa, forage (0.15 ppm); alfalfa, hay (0.04 ppm); barley, hay (0.04 ppm); barley, straw (0.07 ppm); buckwheat (0.07 ppm); clover, forage (0.15 ppm); clover, hay (0.04 ppm); grass, forage (0.15 ppm); grass, hay (0.04 ppm); millet, pearl, forage (0.15 ppm); millet, pearl, hay (0.04 ppm); millet, proso, forage (0.15 ppm); millet, proso, hay (0.04 ppm); millet, proso, straw (0.07 ppm); oats, forage (0.15 ppm); oats, hay (0.04 ppm); oats, straw (0.07 ppm); rye, forage (0.15 ppm); rye, straw (0.07 ppm); sorghum, grain, forage (0.03 ppm); sorghum, grain, stover (0.06 ppm); soybean, forage (0.02 ppm); soybean, hay (0.04 ppm); teosinte, forage (0.15 ppm); teosinte, hay (0.04 ppm); teosinte, straw (0.07 ppm); triticale, forage (0.15 ppm); triticale, hay (0.04 ppm); triticale, straw (0.07 ppm); wheat, forage (0.15 ppm); wheat, hay (0.03 ppm) and wheat, straw (0.03 ppm). At this time, there are currently no established CODEX, Canadian or Mexican MRLs established for residues of flubendiamide/?er se in crop or livestock commodities. Occupational: No chemical-specific data for assessing human exposures during pesticide handling activities were submitted in support of the registration of flubendiamide. EPA used surrogate data from the PHED Version 1.1 (PHED Surrogate Exposure Guide, August 1998) to assess exposures. The level of concern is a Margin of Exposure (MOE) of less than 100. All occupational handler MOEs for flubendiamide are estimated to be greater than 100 at some level of risk mitigation for the proposed uses. Combined dermal plus inhalation risks are not a concern, provided that: (1) Baseline attire (long-sleeved shirt and long pants and shoes plus socks) is worn by all occupational handlers; (2) Handlers mixing and loading liquid concentrates to support aerial and chemigation applications wear ------- chemical-resistant gloves such as barrier laminate, butyl rubber, nitrile rubber or viton; and (3) Pilots use enclosed cockpits. There is the possibility for agricultural workers to have post-application exposure to flubendiamide following its proposed agricultural crop uses. Therefore, occupational post-application exposures and risks were assessed using data from flubendiamide- specific DFR studies and using EPA's default assumptions that 20% of the initial application is available for transfer on day 0 (i.e., 12 hours after application) and that the residue dissipates at a rate of 10% per day following treatment. For flubendiamide, the exposure durations for non-cancer post-application risk assessment were short- (1 to. 30 days) and intermediate-term (>30 days and up to several months). However, since the dermal toxicological endpoint of concern is the same for short- and intermediate-term exposures, the short- and intermediate-term post-application risks are numerically identical. Inhalation exposures are thought to be negligible hi outdoor post-application scenarios, since flubendiamide has a relatively low vapor pressure (7.5 x 107 mm Hg). It should be noted that the grape and corn flubendiamide-specific DFR data indicate that flubendiamide does not dissipate characteristically in a steady state. Rather, there is evident fluctuation up and then down, though the ultimate trend is downwards. In fact, the highest residue value detected in the entire study was detected on corn on the 2nd day after the last treatment. That observation (0.390 ug/cm2) is higher than the residue value calculated for corn using EPA default assumptions (0.21 ug/cm2) by a factor of 1.86 (0.390/0.21 = 1.86). To ensure that the post-application assessments, using default DFRs are protective, EPA conducted a highly conservative assessment assuming that all the default DFRs would be 1.86x higher if flubendiamide-specific data were generated on each of those crops (an assumption that is not likely, since in the case of grapes, the DFR residues were less than the default assumptions). Therefore, even when assuming an extraordinarily worse-case scenario, post- application exposure to flubendiamide does not pose a risk to occupational workers. Flubendiamide is classified in acute toxicity category III for acute dermal toxicity and category IV for primary eye irritation and primary skin irritation. It is not a dermal sensitizer. A restricted entry interval (REI) of 12 hours is appropriate and meets the requirements of the Worker Protection Standard for Agricultural Pesticides (WPS). ENVIRONMENTAL RISK ASSESSMENT Ecological Effects The Agency has determined, based on the proposed uses, that there is no potential risk to freshwater and marine fish, marine crustaceans, marine mollusks and aquatic plants at the limit of solubility for parent flubendiamide. In addition, there is no ------- potential acute risk or reproductive effects to birds and mammals, earthworms, beneficial insects including honey bees and natural Lepidoptera predators, and terrestrial plants for all of the proposed uses. There is a potential risk to freshwater benthic invertebrates exposed to flubendiamide and its degradate des-iodo. EPA has compared the body of toxicological data for the parent compound and des-iodo. With the possible exception of chronic testing with chironomid midges, there is no apparent difference in toxicity evident from the available data. In the case of the chironomid data, conversion of effect endpoints to pore water units results in an estimated NOAEC for the parent compound of approximately 1 ug/L. The corresponding NOAEC for des-iodo is 0.28 ug/L. Because of the estimated nature of the parent compound NOAEC (the value is estimated from the relationship between nominal and pore water measurements at other dose levels because actual measurements of pore water concentrations were not made at the NOAEC level) and because NOAEC comparisons are usually confounded by the dose selections at study design onset, EPA concluded that there was insufficient data to demonstrate a significant difference in toxicity between the parent and degradate. However, for the purposes of risk assessment and in consideration of the use of data as prescribed in the Agency's Risk Assessment Overview Document, risk calculations are based on the chronic endpoints established for each chemical, specifically. Using these NOAEC values, RQs for parent flubendiamide would range from 0.94 to 21.3. Considering only the accumulation within the first 30 years of use for all of the crop scenarios, RQs for the des-iodo degradate would range from 0.03 to 6.9 in the 1st year, 2.9 to 64 in the 10th year, 4.9 to 127 in the 20th year and 12 to 190 in the 30th year. Uncertainties in the model results make longer term estimates of accumulation and risk unreliable. However, due to the persistence of both the parent and degradate, there is a concern for potential accumulation in aquatic sediments over time. Testing of the formulated products 480 SC and 24 WG resulted in RQs ranging up to 0.1 for freshwater invertebrates. Results of a mesocosm study conducted with the formulated products also did not identify any serious risk concerns for water column invertebrates. Adult ladybird beetles are potentially at risk due to ingestion of food items (aphids and pollen) containing flubendiamide residues. In addition, there is a potential direct risk to non-target lepidopterous species, including endangered species. Lepidoptera may occur in areas adjacent to treated fields, where they may be exposed to spray drift, and will likely move through treated fields. Further, the larvae of some lepidopterous species are aquatic and; therefore, may be exposed to both the parent formulation and the des-iodo degradate. The Agency is concerned about the possible accumulation of flubendiamide and des- iodo in aquatic sediments and the effects that this would have on freshwater benthic organisms. However, given the benefits described below, the Agency is granting ------- registration for this chemical at this time. The risk mitigation required and conditions of registration for this chemical, as described below, are designed to address these concerns and to provide adequate information that will allow the Agency to determine: (1) if the required risk mitigation is adequate or, if this is still uncertain; and (2) through a monitoring program, determine the rate and extent of accumulation of the parent and degradate in the most vulnerable areas of use during the time period of the 5-year conditional registration. Environmental Fate and Transport Hydrolysis/Photolysis: Flubendiamide is stable to hydrolysis under laboratory conditions, but direct aqueous photolysis appears to be a main route of degradation. Flubendiamide degrades to NNI-OOOl-des-iodo (des-iodo), with a half-life estimated as 11.56 days. Flubendiamide degrades to des-iodo under laboratory soil photolysis with a half-life estimated as 35.3 days. Volatilization from soil and water surfaces is not expected to be an important dissipation route since flubendiamide has a relatively low vapor pressure (7.5 x 10"7mm Hg) and Henry's Law constant (8.9 x 10"11 atm-m /mol). Mobility/Transport: Flubendiamide is expected to be slightly to hardly mobile (KFoc = 1,076 to 3,318 L/Kg). Des-iodo is expected to be moderately mobile (KFoc = 234 to 581 L/kg). The main transformation product, des-iodo, is more mobile than the parent; however, des-iodo was only detected in a small quantity (<3.4% of the applied) at the 0 to 15 cm soil depth at 3 sites in the terrestrial field studies. Flubendiamide and des-iodo have the potential to contaminate surface water through run-off due to their persistence in soil and also have the potential for groundwater contamination in vulnerable soils with low organic carbon content, after heavy rainfall and/or in areas with high water tables (because there is less depth to travel before reaching groundwater). Soil/Water Degradation: Flubendiamide is stable under aerobic and anaerobic soil metabolism and aerobic aquatic metabolism laboratory conditions. In aerobic and anaerobic aqueous environments, flubendiamide is expected to dissipate somewhat faster than in aerobic soil, likely as a result of metabolism. Laboratory experiments using anaerobic and aerobic aquatic systems resulted in flubendiamide half-lives (water plus soil/sediment) of 127 to 364 days and 32.8 to 533.2 days, respectively. Anaerobic aquatic metabolism is another main route of degradation for flubendiamide. Flubendiamide degrades to des-iodo under anaerobic aquatic conditions with a half-life estimated as 365 days. Flubendiamide and des-iodo's overall stability/persistence suggests that they will accumulate in soils, water column and sediments with each successive application. Terrestrial Field Dissipation: Flubendiamide also degrades in the field condition very slowly. In terrestrial field experiments, flubendiamide half-lives in 3 soils ranging from loamy sand to silt loam were 210 to 770.2 days (leaching to a depth of 30 to 60 cm) and in a sandy loam soil under outdoor conditions, the half-life was 322 days. In an aerobic soil environment, flubendiamide is expected to dissipate slowly, hi the ------- laboratory using 4 soils ranging from loamy sand to silt, flubendiamide was stable with <5% of the applied chemical dissipating at 371 days post-treatment. REGULATORY DECISION Conditional Registration: A 5-year conditional registration has been granted for flubendiamide use as an insecticidal control of various lepidopterous insect pests on corn, cotton, tobacco, tree fruit, tree nuts, vine crops and vegetable crops. Flubendiamide may be a viable alternative to comparably registered and existing pesticides that tend to pose greater risk concerns and may also be an important tool as a rotational insecticide to limit or prevent the development of resistance to other insecticide chemistries. Flubendiamide has also been identified as an OP alternative for the control for the control of leafroller and fruitworm pests in tree fruit production, where the dominant pesticides used have been azinphos-methyl, chlorpyrifos and phosmet. The EFED risk assessment; however, suggests that both flubendiamide and des-iodo will accumulate to concentrations in aquatic environments that will pose risk to freshwater benthic invertebrates. As a result, EPA is requiring certain measures which the Agency believes may be effective in mitigating the apparent risk, including the requirement 15-foot vegetative buffer zones which are expected to reduce run-off of both parent and degradate to the aquatic environment, reduced application rates and other labeling statements which reduce the allowable total loading in one year and environmental hazards, ground water and surface water advisories. To confirm the utility of the 15-foot vegetative buffers, the Agency is requiring a small-scale run-off/vegetative buffer strip study. If the utility of the 15-foot buffers cannot be demonstrated to achieve reductions in off-site transport and aquatic organism risk that would alleviate the risk concern, the Agency is requiring a monitoring program, the results of which allow the Agency to determine, at the end of the 5-year conditional registration, the rate and extent of accumulation in the most vulnerable use areas. If there are risk concerns at that time that result in the Agency being unable to determine that there are no reasonable adverse effects to the environment, the registrants have agreed that the pesticide will be voluntarily cancelled. Conditional Data: The registrant has committed to submit the following data: 1. Flubendiamide • (Non-guideline) Small-Scale Runoff/Vegetative Buffer Strip Study - The quantitative efficacy of vegetative buffers for flubendiamide use is uncertain. To determine the magnitude of the parent, flubendiamide, retained in buffer strips, the small-scale run-off/vegetative buffer strip study and monitoring program will allow the Agency to quantitatively consider the impact of such buffers on the risk picture. The protocols for the studies will be mindful of the ------- need to both consider the variety of proposed use sites as well as a variety of buffer conditions. If the employment of label enforceable buffers is empirically demonstrated to alleviate the risk concern, then no further work need be conducted. However, if buffers cannot be demonstrated to achieve these meaningful risk reductions, the other areas of critical uncertainty in the modeling assumptions must be considered. In this case, there is considerable uncertainty in the application of the EXAMS pond scenario for chemicals with suspected aquatic system accumulation. Additional information on the actual potential for the pesticide to build up in receiving waters would address the uncertainty associated with current model limitations. Therefore, a monitoring study of receiving waters within watersheds where flubendiamide will be used will be required. 2. Des-iodo Degradate • (161-1) Hydrolysis - A hydrolysis study to establish the significance of chemical hydrolysis as a route of degradation for des-iodo and to identify, if possible, the hydrolytic products formed to provide initial information on whether they may exhibit structures that may potentially adversely affect non- target organisms. • (162-4) Aerobic Aquatic Metabolism - An aerobic aquatic metabolism study to determine the effects of des-iodo on aerobic conditions in water and sediments during the period of dispersal of des-iodo throughout the aquatic environment and to compare rates and formation of metabolites. The data from this study would provide the aerobic aquatic input parameter for PRZM/EXAMS; therefore, potentially reducing modeling uncertainty. 3. For the submitted GLN 860.1850 Confined Rotational Crop studies (MRIDs 46817133 and 46817134), the registrant will submit extraction and analysis dates of samples in order to confirm that samples were extracted and analyzed within the stated intervals (or within 6 months of harvest). Otherwise, additional storage stability data may be required by EPA. BENEFIT DETERMINATIONS: Since flubendiamide is a novel chemistry, the Agency believes that it may be a viable alternative to comparably registered and existing pesticides that tend to pose greater risk concerns. Also, it may be an important tool as a rotational insecticide to limit or prevent the development of resistance to other insecticide chemistries. BEAD'S preliminary analysis of the material submitted by the registrant concludes that flubendiamide provides Lepidoptera control equivalent or superior to the insecticides currently being used for pest control in the evaluated crops. Materials submitted also suggest low toxicity to terrestrial insect predators and honey bees which should make flubendiamide an important component in IPM programs. When assessing recent pesticide usage data for currently registered insecticide products aimed at controlling lepidopterous pests in corn, several market leaders are of concern to ------- the Agency. Flubendiamide's toxicity to terrestrial organisms is low, especially in comparison to the current active ingredients most commonly used against the labeled target pests. For pesticides used to control cotton pests such as the beet armyworm and bollworm, the usage information for products used in 2007 was more broadly distributed among chemical pesticides than that indicated for corn usage, with a number of synthetic pyrethroids, namely lambda cyhalothrin, and other chemistries such as acephate and chlorpyrifos leading the usage profile. In addition, flubendiamide has been identified as an organophosphorus pesticide alternative for the control of leafroller and fruitworm pests in tree fruit production, where the dominant pesticides used have been azinphos-methyl, chlorpyrifos and phosmet. Therefore, flubendiamide is a chemical that broadens the diversity of pest control measures available to growers for the reasons stated above. REQUIRED LABEL STATEMENTS The end-use product labels containing flubendiamide as an active ingredient will be amended as follows: 1. Requirement of 15-foot vegetative buffer zones and the addition updated spray drift language for aerial/ground applications for similar products with similar use patterns on both end-use labels. 2. On the proposed label for 24 WG, the registrant will reduce application rates, revise the maximum amount of product applied per acre "per year" to a "per crop season" basis and remove the number of applications per crop season for the Brassica, Cucurbits, Leafy Vegetables and Fruiting Vegetables crop groupings in order to reduce the per year loading allowed. 3. Addition of revised environmental hazards, ground water and surface water advisories to both end-use labels. 4. On the proposed label for 480 SC, the registrant will be required to clearly articulate what application method(s) are proposed for each listed crop. 5. The proposed rotational crop restriction for root crops (root, tuber and bulb vegetables), which specifies that "treated areas may be replanted immediately following harvest, or as soon as practical following the last application" will be revised to a 30-day plant-back interval on both end-use labels. GOVERNMENT PERFORMANCE AND RESULTS ACT (GPRA) Registering flubendiamide will meet the objectives of GPRA title 3.1.1 by assuring new pesticides that enter the market are safe for humans and the environment. ------- CONTACT PERSON AT EPA Mailing Address: Mr. Richard J. Gebken, Product Manager (10) Environmental Protection Agency Office of Pesticide Programs Registration Division (7505P) Insecticide Branch 1200 Pennsylvania Avenue, NW. Washington, D.C. 20460-0001 Office Location and Telephone Number: Room S-7319, One Potomac Yard 2777 S. Crystal Drive Arlington, VA 22202-4501 703-308-9354 DISCLAIMER: The information presented in this Pesticide Fact Sheet is for informational purposes only and may not be used to fill data requirements for pesticide registration. The information is believed to be accurate as of the date on the document. ------- Appendix 1 — Structure and Nomenclature Flubendiamide Nomenclature Chemical structure Empirical Formula Common name Company experimental name IUPAC name CAS name CAS registry number End-use products (EPs) Chemical Class Known Impurities of Concern [ O HjC CHj ^^,A^N^X^/S02CH3 TJ \^Y>° IW\vxx^>N ! /^\-t?^^ ^-CF, IT *~- \X^ \.-^ 3 ^ P\ CF3 C23H22F7IN204S Flubendiamide (proposed ISO name) NNI-0001 N2-[ 1 , 1 -Dimethyl-2-(methylsulfonyl)ethyl-3-iodo-V - {2-methyl-4-[ 1 ,2,2,2- tetrafluoro-l-(trifluoromethyl)ethyl]phenyl}phthalamide A^2-[l,l-Dimethyl-2-(methylsulfonyl)ethyl-3-iodo-V-[2-methyl-4-[l,2,2,2- tetrafluoro- 1 -(trifluoromethyl)ethyl]phenyl] - 1 ,2-benzenedicarboxamide 272451-65-7 NNI-0001 480 SC (EPA File Symbol 264-XXX) NNI-0001 24 WG (EPA File Symbol 264-XXX) Phthalic acid diamide insecticide None ------- Appendix 2 -- Physical and Chemical Properties Physicochemical Properties of Flubendiamide. Parameter Molecular weight Melting point/range PH Density Water solubility Solvent solubility Vapor pressure Dissociation constant, pKa Octanol/water partition coefficient, Log(Kow) UV/visible absorption spectrum Value 682.39 g/mol 217.5-220.7 °C 6.05 (20 °C) 1.659g/mL(20°C) 29.90 ug/mL (20 °C) Solvent /7-xylene n-heptane methanol 1 ,2-dichloroethane acetone ethyl acetate 1Q-4 Pa (25°C) Solubility (g/L) 0.488 0.000835 26.0 8.12 102 29.4 Does not dissociate 4.2 (pH 5.9, 25°C) 204.4 nm (neutral methanol) Reference Product Chemistry Review of Flubendiamide Technical. ------- Appendix 3 - Toxicity Profiles Acute Toxicity Profile - Flubendiamide Guideline No. 870.1100 870.1200 870.1300 870.2400 870.2500 870.2600 Study Type Acute oral - rat Acute dermal- rat Acute inhalation - rat Acute eye irritation -rabbit Acute dermal irritation - rabbit Skin sensitization - guinea Pig MRID(s) 46817144 46817147 46817150 46817203 46817206 46817209 Results LD50 = >2000 mg/kg LD50 = >2000 mg/kg LC50 = >0.0685 mg/L Irritating (slight) Non-irritating Negative Toxicity Category III III III IV IV N/A Subchronic, Chronic and Other Toxicity Profile Guideline No. 870.3050 870.3050 870.3050 870.3100 Study Type 28-Day Oral (rat) Not Submitted* 28-Day Oral (mice) Not Submitted* 28-Day oral toxicity (dog) Not Submitted* 90-Day oral toxicity (rat) MRID No. (year)/ Classification /Doses ppm: 0 - 20 - 50 - 200 - 2000 - 20000 mg/kg/day: M: 0-1.53 -3.88 -15.1 -52-1575 F:0-1.63-4.17-16.1- 156-1605 ppm: 0 - 20 - 200 - 2000 - 20000 mg/kg/day: M: 0-2.73 -26.9 -265- 2678 F: 0-2.88 -30.0 -299- 3024 ppm: 0-40-400-4,000- 40,000 mg/kg/day: M:0-l. 12-10.7-101- 1111 F: 0-1. 10 -12.0 -120- 1180 46817210(2003)/ Acceptable/guideline ppm: 0 - 20 - 50 - 200 - 2000 - 20000 mg/kg/day: M:0-l. 15-2.85-11.4 -116-1192 F: 0-1.30 -3.29 -13.1 - 128-1320 Results NOAEL (M/F) =15.1/4.17 mg/kg/day LOAEL (M/F) =152/16.1 mg/kg/day based on: liver: t(m/f>- periportal fatty change, fwt [abs/rel (m/f)] i(f)-ALP t(f>- GPT NOAEL (M/F) = 26.9 / 30.0 mg/kg/day LOAEL (M/F) = 265 / 299 mg/kg/day based on: liver: ^(m/f)- hypertrophy (centrilobular hepatocytes);t(m)-[dark-colored + fatty change (centrilobular hepatocytes)] NOAEL (M/F) =10.7/1.10 mg/kg/day LOAEL (M/F) = 101 / 12.0 mg/kg/day based on: t(m/f)- ALP NOAEL (F) = 13.1 mg/kg/day LOAEL (F) = 128 mg/kg/day based on: slight hepatotoxicity (f(f) - periportal fatty change, hepatocellular hypertrophy, twt [abs/rel(f)], TGGT ------- Subchronic, Chronic and Other Toxicity Profile Guideline No. 870.3150 870.3150 870.3200 870.3700a 870.3700b Study Type 90-Day oral toxicity (mouse) 90-Day oral toxicity (dog) 28/29-Day dermal toxicity (rat) Prenatal developmental in (rat) Prenatal developmental in (rabbit) MRID No. (year)/ Classification /Doses 46817211(2002)7 Acceptable/guideline ppm: 0-50-100-1000- 10000 mg/kg/day: M: 0-6.01 -11.9 -123- 1214 F: 0-7.13 -14.7 -145- 1424 46817212 and 46817242 (2003)/ Acceptable/guideline ppm: 0-100-2000-40000 mg/kg/day: M: 0-2.58 -52.7 -1076 F: 0-2.82 -59.7 -1135 46817213(2004)/ Acceptable/guideline mg/kg/day: 0-10-100-1000 468 172 15 and 468 17241 (2003)/ Acceptable/guideline mg/kg/day: 0-10-100-1000 468 172 14 and 468 17240 (2002)/ Acceptable/guideline mg/kg/day: 0-10-100-1000 Results NOAEL (M/F) = 1 1.9 / 14.7 mg/kg/day LOAEL (M/F) =123/145 mg/kg/day based on slight hepatotoxicity: (ffatty change, hepatocellular hypertrophy, | abs/rel wt [f]) NOAEL (M/F) = 2.58 / 2.82 mg/kg/day LOAEL (M/F) = 52.7 / 59.7 mg/kg/day based on clinical signs of toxicity (loose stool), shortened APTT, increased ALP and triglycerides, increased adrenal weights, and microscopic effects on the adrenal glands in females: adrenal: |(f) - cortical hypertrophy; f(f) - wt i(m/f) - APTT t - [ALP(m/f), Triglycerides(f)] NOAEL = 100 mg/kg/day (systemic); 1000 mg/kg/day (local skin) LOAEL = 1000 mg/kg/day based on: liver: f(m/f)-periportal fatty change + fwt [abs/rel]; thyroid: f(f)-follicular cell hypertrophy i(f) -[Hct + MCV + MCH] 4(f) - AST Maternal: NOAEL = 10 mg/kg/day; LOAEL = lOOmg/kg/day based on: liver: twt[abs/rel]. Developmental: NOAEL >1000 mg/kg/day; LOAEL was not observed (>1000 mg/kg/day). Maternal: NOAEL= 100 mg/kg/day; LOAEL = 1000 mg/kg/day based on: food consumption decreaseon last day of treatment (GD27-28) and loose stool Developmental: NOAEL >1000 mg/kg/day; LOAEL not observed (>1000 mg/kg/day) ------- Subchronic, Chronic and Other Toxicity Profile Guideline No. Study Type MRTO No. (year)/ Classification /Doses Results 870.3800 Two-generation Reproduction and fertility effects (rat) 46817216(2004)7 Acceptable/guideline ppm: 0 - 20 - 50 - 2000 - 20000 mg/kg/day (premating doses): Pm: 0-1.30-3.30-131 -1307 Pf: 0-1.59 -3.95 -159- 1577 Flm: 0-1.64-4.05- 162-1636 Flf: 0-1.84-4.59-176 -1808 Parental/Systemic: NOAEL (M/F) = 3.30 / 3.95 mg/kg/day; LOAEL (M/F) = 131/159 mg/kg bw/day based on: liver: tP/Flm- [brown pigment deposition + wt (rel)]; fPf /Flf-[enlarged/dark-colored livers + hepatocyte hypertrophy + periportal fatty change + brown pigment deposition + wt]; thyroid: |P/F1 -[follicular cell hypertrophy]; twt (abs Pm); kidney: tPf-[tubular basophilic change + urinary casts]; tPf /Flf— wt; ovary: fPf -interstitial cell vacuolation; uterus: |wt (Pf); pituitary: |.wt (Fl); spleen: |wt(Pf/Flf) Reproductive: No effect of treatment on: precoital interval; mating, fertility, or gestation indices; or gestation duration in either generation. Furthermore, the numbers of primordial ovarian follicles in the 20,000 ppm Fl dams were comparable to controls. No effects were noted on estrous cycle duration or sperm parameters. The NOAEL is 20,000 ppm (1307/1577 mg/kg/day males/females, respectively). The LOAEL for reproductive toxicity was not observed. Offspring: NOAEL = 3.30 mg/kg/day; LOAEL =131 mg/kg/day based on: liver: f- [hepatocyte hypertrophy, diffuse fatty change, brown pigment deposition, proliferation bile ducts; wt]; thyroid: f follicular cell hypertrophy; spleen + thymus: |wt; feyeball enlargement One-generation reproduction study in rat 46817239 (2004)/Acceptable/nongui deline ppm: 0-50-200-2000-20,000 mg/kg/day: Pm: 0-3.25-12.91-127.2- 1287 Pf: 0-3.84-14.97-148.9- 1490 Parental: LOAEL is 2000 ppm (127.2/148.9 mg/kg/day in amles/females, respectively) bsed on effects on the liver, thyroid, and kidneys. The NOAEL is 200 ppm (12.91/14.97 mg/kg/day in males/females, respectively). Reproductive: The LOAEL was not observed and the NOAEL is 20,000 ppm (1287/1490 mg/kg/day in males/females, respectively). Offspring: The LOAEL is 2000 ppm (127.2/148.9 mg/kg/day in males/females, respectively) based on effects on the eyes and liver; and on increased anogenital distance and delayed sexual maturation in the males. The NOAEL is 200 ppm (12.91/14.97 mg/kg/day in males/females, respectively). ------- Subchronic, Chronic and Other Toxicity Profile Guideline No. 870.4100a 870.4 lOOb 870.4200a 870.4200b Study Type Histopathology of the Eyes of Weanlings in a One-generation Reproduction Study in Rats Perinatal Ocular Toxicity Study in CD-I Mice following exposure via diet Chronic toxicity (rat) Chronic toxicity (dog) Carcinogenicity (rat) Carcinogenicity (mouse) MRTO No. (year)/ Classification /Doses 468 1 7238/Acceptable/non -guideline ppm: 0-50-200-2000-20,000 mg/kg/day: Pm: 0-3.25-12.91-127.2- 1287 Pf: 0-3.84-14.97-148.9- 1490 46817236/ non-guideline approx. 1000 mg/kg/day from day 6 post conception until lactation day 21 46817217(2004)/ Acceptable/guideline ppm: 0 - 20 - 50 - 2000 - 20000 mg/kg/day: M: 0-0.8 -2.0 -79.3- 822 F: 0-1.0 -2.4 -97.5- 998 46817218 Acceptable/guideline ppm: 0-100-1500-20000 mg/kg/day: M: 0-2.21 -35.2 -484 F: 0-2.51 -37.9 -533 46817219(2004)/ Acceptable/guideline ppm: 0-50-1000-20000 mg/kg/day: M: 0-1.70 -33.9 -705 F: 0-2.15 -43.7 -912 4681 7220 (2004)/ Acceptable/guideline ppm: 0-50-1000-10000 mg/kg/day: M: 0-4.85 -94 -988 F: 0 - 4.44 - 93 - 937 Results Offspring: The LOAEL for offspring toxicity is 2000 ppm (127.2/148.9 mg/kg/day in males/females, respectively) bsed on confirmed microscopic effects on the eyes in both sexes. The NOAEL is 200 ppm (12.91/14.97 mg/kg/day in males/females, respectively). Eye lesions of viable pups were noted neither during the lactation period nor during the follow-up period lasting from PND 22-42. Offspring: The LOAEL for offspring toxicity is 4500/2000 ppm (equivalent to 1052.3 mg/kg/day) based on decreased pup body weights and body weight gains. The NOAEL was not established. NOAEL (F) = 2.4 mg/kg/day. LOAEL (F) = 97.5 mg/kg/day based on: hepatotoxicity (periportal fatty change, hepatocyte hypertrophy, twt [abs/rel] and tGGT NOAEL (M/F) = 2.21 / 2.51 mg/kg/day. LOAEL (M/F) = 35.2 / 37.9 mg/kg/day based on: liver: twt [abs m+f, rel(m)] |(m) - BWG and BW i -[APTT(m/f), t(m/f) - ALP NOAEL (M/F) =1.70/2.15 mg/kg/day. LOAEL (M/F) = 33.9 / 43.7 mg/kg/day based on: liver: t(m/f)- [periportal fatty change, hypertophy] ;f wt [abs/rel(m/f)]; kidney: !(m/f)- chronic nephropathy; jwt [rel(f)] No evidence of Carcinogenicity NOAEL (M/F) = 4.85 / 4.44 mg/kg/day. LOAEL (M/F) = 94/93 mg/kg/day based on: hepatotoxicity (periportal fatty changes, hypertophy); thyroid changes (ffollicular cell hypertrophy with hydropic change, f large sized follicles) No evidence of Carcinogenicity ------- Subchronic, Chronic and Other Toxiciry Profile Guideline No. 870.5100 870.5100 870.5300 870.5375 870.5395 870.5395 870.6200a 870.6300 Study Type Gene mutation (in vitro bacteria) Gene mutation (in vitro bacteria) Gene Mutation (in vitro mammalian V79) Mammalian Cytogenetics (in vitro CHL) Mammalian Cytogenetics (micronucleus mouse) Mammalian Cytogenetics (micronucleus mouse) Acute neurotoxicity screening battery Developmental neurotoxicity MRTO No. (year)/ Classification /Doses 46817221 Acceptable/guideline 0-3.86-11.6-34.7- 104-313 ug/plate (w/o activation) 0-61.7-185-556- 1,670-5,000 ug/plate (+ activation) 46817222 Unacceptable/guideline 0-16-50-158-500- 158 1-5000 ug/plate (+/- S9 activation) (conducted w/ NNI-0001 SC) 46817224 Acceptable/guideline 0-7.5-15-30-60- 120-240 ug/ml (+/ - activation) Acceptable/guideline 0-550-1100-2200 ug/ml (+ activation) 0 -(125-550) - (250- 11 00) -(500-2200) ug/ml; 6, 20, or 40 hrs exp. (w/o activation) 46817226 Acceptable/guideline 0 - 1000 - 2000 - 4000 mg/kg 46817225 Acceptable/guideline 0-500-1000-2000 mg/kg 46817227 Acceptable/guideline mg/kg/day: 0-209-731-2213 (analytically determined) 46817228 Acceptable/non-guideline ppm: 0-120-1200-12000 ppm mg/kg/day (based on last 2 wks of gestation and 3 wks of lactation): 0 - 9.9 - 99.5 - 979.6 Results Negative Negative Negative Negative Negative Negative NOAEL = 2213 mg/kg/day LOAEL = Not observed (>2213 mg/kg/day) Maternal: NOAEL = 9.9 mg/kg/day LOAEL = 99.5 mg/kg/day based on: liver: |wt[abs/rel]. Offspring: NOAEL = 9.9 mg/kg/day LOAEL = 99.5 mg/kg/day based on tbalanopreputial separation time: this LOAEL is also protective of adverse eye effects reported at 979.6 mg/kg/day (eye - [enlarged eyeball + exophthalamus + general ocular opacity(m)]) ------- Subchronic, Chronic and Other Toxicity Profile Guideline No. 870.7485 870.7600 870.7800 Study Type Metabolism and pharmacokinetic s -rat Dermal penetration (monkey) 4-week Immunotoxicity (plaque-forming assay in rat) Effects on Thyroid Hormones and Liver Enzymes in Female Rats In vitro Metabolism in rat, mouse, dog and human microsomes Toxicokinetic study in rats and mouse MRTO No. (year)/ Classification /Doses 468 17229, 468 17230 and 46817231 Acceptable/guideline 46817234 Acceptable/non-guideline 46817243 Acceptable/guideline ppm: 0-40-400-4000 mg/kg/day: M: 0-3.34 -33.6 -336.3 F: 0-4.0 -38.4 -358.8 46817235 Acceptable/non-guideline ppm: 0-1000-10,000 mg/kg/day: 0-83-812 46817232 Acceptable/Non-guideline 46817233 Acceptable/Non-guideline Results Oral absorption = 23.5/34.1% in m/f, respectively (average = 29%); see Section 3.2 Appendix A. 3 for more information Intravenous injection of [14CJNNI- 0001 resulted in excretion of a large fraction of the dosed radioactivity in feces. Total recoveries through 360 hours post-dose were 80.91% in feces, 7.78% in urine, and 4.1 1% in cage debris/rinse samples. Dermal application of [14C]NNI-0001 resulted in a negligible absorption of 0.02% at 8 hrs post-dose. The overall mean total recovery of radioactivity from excreta and from the application site was 105.15%, the majority of which was associated with the radioactivity recovered from the application site. NOAEL (M/F) = 336/358.8 mg/kg/day. No evidence of primary immunotoxicity Study generally support this indirect effect on the thyroid via induction of enzymes in the liver. Direct effects on the liver included increases in organ weights, cytochrome P450, UDP-GT and EROD activities, and incidences of hepatocyte hypertrophy and vacuolation. see Appendix A. 3 for more information see Appendix A.3 for more information The studies designated as "Not Submitted" were included in the registrant's toxicity profile table, which in turn was in the registrant's human health risk assessment (MRID 46817252, p. 42); there are reported here in order to be as thorough, complete and inclusive as possible. ------- Appendix 4 - Ecological Effects Data Ecological Effects Data Requirements for Flubendiamide Guideline # 71-1 71-2 71-4 72-1 72-2 72-3(a) 72- 3(b) 72-3(c) 72-4(a) 72- 4(b) 72-5 122- l(a) 122- l(b) 122-2 122-2 850.2100 850.2200 850.2300 850.1075 850.1010 850.1075 850.1025 850.1035 850.1045 850.1400 850.1300 850.1350 850.1300 850.1790 850.1500 850.4100 850.4150 850.4400 850.4400 Data Requirement Avian Oral LD50 Avian Dietary LCso Avian Reproduction Freshwater Fish LC50 Freshwater Invertebrate LC50 Estuarine/Marine Fish LC50 Estuarine/Marine Mollusk EC50 Estuarine/Marine Shrimp LC50 Freshwater Fish Early Life Stage Aquatic Invertebrate Life-cycle Benthic Organisms Mesocosm Study Freshwater Fish Life-Cycle Seed Germination/ Seedling Emergence Tierl Herbicidal Toxicity Terrestrial plants Tier 2 Vegetative Vigor Tierl Aquatic Plant (Non- Vascular) Tier l&II Aquatic Plant (Vascular) Tier 2 Formulation Technical 480 SC Technical Technical Technical Technical Technical Technical Technical Technical 480 SC 480 SC Technical 24 WG 480 SC 480 SC Des-iodo Technical Technical Technical Technical Technical Technical 480 SC Technical 24 WG 480 SC Des-iodo 480 SC Technical 24 WG 480 SC 480 SC Technical 24 WG Technical 480 SC Technical MRID (Accession #) 46817003 46817004 46817005 46817006 46817007 46817008 46816937 46816939 46816940 46816941 46816942 46816943 46816930 46816932 46816931 46816934 46816933 46816938 46816935 46816936 46816947 46816944 46816946 46816945 46817022 46817014 46817013 46817023 46817002 46816948 46817034 46817036(a) 46817035 46817036(b) 46817037 46817041 46817040 46817039 Study Classification Acceptable Acceptable Acceptable Acceptable Supplemental Acceptable Acceptable Acceptable Acceptable Acceptable Acceptable Acceptable Acceptable Acceptable Acceptable Supplemental Acceptable Acceptable Acceptable Acceptable Acceptable Supplemental Acceptable Acceptable Supplemental Acceptable Acceptable Supplemental Supplemental Unacceptable Acceptable Acceptable Supplemental, Non- guideline Acceptable Supplemental Acceptable Acceptable Acceptable ------- Ecological Effects Data Requirements for Flubendiamide Guideline # 123- l(a) 141-1 141-2 850.4225 850.3020 850.6200 850.6200 850.3030 Data Requirement Seed Germination/ Seedling Emergence Tier 2 Honey Bee Acute Contact LD50 Acute Toxicity to Earthworms Chronic Toxicity to Earthworms Honey Bee Residue on Foliage Parasitoid Wasp Predatory Mite Ladybird Beetle (45 day study) Ladybird Beetle (Extended Study) Ladybird Beetle (Life Cycle Test) Parasitic Wasp (Side Effects Tests) White springtail (Reproduction Test) Green lacewing (Extended Study) Formulation 24 WG Technical 480 SC 480 SC WG40 Technical 480 SC Des-iodo 480 SC 24 WG NA WG40 WG40 480 SC 480 SC 480 SC 480 SC 480 SC 480 SC MRID (Accession #) 46817038 46817009 46817010 46817011 46817012 46817028 46817029 46817030 46817031 46817032 NA 46817020 46817019 46817015 46817016 46817017 46817021 46817027 46817018 Study Classification Acceptable Acceptable Acceptable Acceptable Supplemental, Non- guideline Supplemental Supplemental Supplemental Supplemental Supplemental NA Supplemental, Non- guideline Supplemental, Non- guideline Supplemental, Non- guideline Supplemental, Non- guideline Supplemental, Non- guideline Supplemental, Non- guideline Supplemental Supplemental ------- Appendix 5 - Environmental Fate Data Environmental Fate Data Requirements for Flubendiamide Guideline # 161-1 161-2 161-3 161-4 162-1 162-2 162-3 162-4 163-1 163-2 163-3 164-1 165-4 835.212 835.224 835.241 835.237 835.41 835.42 835.44 835.43 835.1240 835.1230 835.141 835.81 835.61 850.173 Data Requirement Hydrolysis Photodegradation in Water Photodegradation on Soil Photodegradation in Air Aerobic Soil Metabolism Anaerobic Soil Metabolism Anaerobic Aquatic Metabolism Aerobic Aquatic Metabolism Leaching- Adsorption/Desorption Laboratory Volatility Field Volatility Terrestrial Field Dissipation Accumulation in Fish Quantum Yield in Water MRID#s 46816907 46816908 46816909 NA' Parent: 46816910 Degradate:46816911 46816912 46816914 46816913 Parent: 468 16905 Degradate: 468 16906 NA NA 46816915 46816916 46816917 46816949 46817001 46816919 Study Classification Acceptable Acceptable Acceptable NA Acceptable Acceptable Supplemental Acceptable Acceptable Supplemental Supplemental NA NA Acceptable Acceptable Acceptable Acceptable Acceptable Supplemental 1 Not Available. ------- Appendix 6 - Bibliography 71-2 Avian Dietary Toxicity MRID Citation Reference 46817005 Bowers, L. (2005) Technical NNI 0001: A Subacute Dietary LC50 with Mallards. Project Number: AS720801, 201263. Unpublished study prepared by Bayer Corp. 41 p. 71-4 Avian Reproduction MRID Citation Reference 46817007 46817008 Sabbert, T. (2004) Effect of Technical NNI 0001 on Mallard Reproduction. Project Number: EBAM0221. Unpublished study prepared by Bayer Corp. 114 p. Bowers, L. (2005) Effect of Technical NNI 0001 on Northern Bobwhite Reproduction. Project Number: AS741701, 201138. Unpublished study prepared by Bayer Corp. 143 p. 72-1 Acute Toxicity to Freshwater Fish MRID Citation Reference 46816937 Kern, M; DeHann, R. (2004) Acute Toxicity of NNI 0001 Technical to the Fathead Minnow (Pimephales promelas) Under Static Conditions. Project Number: EBAM0390/AS811201, 200713. Unpublished study prepared by Bayer Corp. 42 p. 46816939 Dorgerloh, M. (2003) Acute Toxicity of NNI-0001 (Tech.) to Fish (Lepomis macrochirus). Project Number: E/280/2291/4, DOM/22043. Unpublished study prepared by Bayer Ag, Institute of Product Info. & Residue Anal. 49 p. 46816940 Dorgerloh, M. (2003) Acute Toxicity of NNI-0001 (Tech.) to Fish (Oncorhynchus mykiss). Project Number: DOM/22044, E/280/2292/5. Unpublished study prepared by Bayer Ag, Institute of Product Info. & Residue Anal. 75 p. 46816942 Dorgerloh, M. (2003) Acute Toxicity of NNI-0001 480 SC to Fish (Lepomis macrochirus). Project Number: E/280/2352/2, DOM/22081, 00789. Unpublished study prepared by Bayer Ag, Institute of Product Info. & Residue Anal. 42 p. 46816943 Dorgerloh, M. (2003) Acute Toxicity of NNI-0001 480 SC to Fish (Oncorhynchus mykiss). Project Number: E/280/2354/4, DOM/22082, 00789. Unpublished study prepared by Bayer Ag, Institute of Product ------- Info. & Residue Anal. 42 p. 72-2 Acute Toxicity to Freshwater Invertebrates MRID Citation Reference 46816930 46816931 46816932 46816933 46816934 Dorgerloh, M. (2006) Acute Toxicity of NNI-0001 (tech.) in Water Fleas (Daphnia magna). Project Number: DOM/22041, E/320/2283/0, MR/391/02. Unpublished study prepared by Bayer Ag, Institute of Product Info. & Residue Anal. 39 p. Dorgerloh, M. (2003) Acute Toxicity of NNI-0001 SC 480 to Water Fleas (Daphnia magna). Project Number: E/320/2284/1, DOM/22042. Unpublished study prepared by Bayer Ag, Institute of Product Info. & Residue Anal. 43 p. Dorgerloh, M. (2005) Acute Toxicity of NNI-0001 WG 24 to the Waterflea Daphnia magna in a Static Laboratory Test System. Project Number: P/684/027017, MR/188/02, EBAMX018. Unpublished study prepared by Bayer Ag, Institute of Product Info. & Residue Anal. 58 p. Dorgerloh, M. (2004) Acute Toxicity of NNI-0001-des-iodo to the Waterflea Daphnia magna. Project Number: DOM/23055, MR/029/04, E/320/2503/5. Unpublished study prepared by Bayer Ag, Institute of Product Info. & Residue Anal. 43 p. Dorgerloh, M. (2005) Acute Toxicity of NNI-0001 SC 480 in the Waterflea Dahnia magna Under Different Feeding Conditions in a Static Laboratory Test System. Project Number: E/320/2849/8, EBAMX028, MR/188/02. Unpublished study prepared by Bayer Ag, Institute of Product Info. & Residue Anal. 59 p. 72-3 Acute Toxicity to Estuarine/Marine Organisms MRID Citation Reference 4681693 5 Dionne, E. (2004) NNI-0001 -Acute Toxicity to Eastern Oysters (Crassostrea Virginia) Under Flow-Through Conditions. Project Number: AS881501, 13798/613, EBAM0380. Unpublished study prepared by Springborn Smithers Laboratories. 53 p. 46816936 Dionne, E. (2004) NNI-0001 - Acute Toxicity to Mysids (Americamysis bahia) Under Static Conditions. Project Number: 13798/6131, AS883101, EBAMO376. Unpublished study prepared by Springborn Smithers Laboratories. 49 p. 46816938 Banman, C.; Kern, M.; Lam, C. (2004) Acute Toxicity of NNI 0001 Technical to the Sheepshead Minnow (Cyprinodon variegatus) Under Static Conditions. Project Number: 200992, EBAM0370. Unpublished ------- study prepared by Bayer Corp. 31 p. 72-4 Fish Early Life Stage/Aquatic Invertebrate Life Cycle Study MRID Citation Reference 46816944 Dorgerloh, M. (2003) Influence of NNI-0001 (Tech.) on Development and Reproductive Output of the Waterflea Daphnia magna in a Static Renewal Laboratory Test System. Project Number: E/321/2267/3, DOM/22035, 00760. Unpublished study prepared by Bayer Ag, Institute of Product Info. & Residue Anal. 88 p. 46816945 Dorgerloh, M. (2003) Influence of NNI-0001 SC 480 on Development and Reproductive Output of the Waterflea Daphnia magna in a Static Renewal Laboratory Test System. Project Number: E/321/2372/0, DOM/23001, 00760. Unpublished study prepared by Bayer Ag, Institute of Product Info. & Residue Anal. 81 p. 46816946 Putt, A. (2005) NNI-0001 - Life-Cycle Toxicity Test with Mysids (Americamysis bahia). Project Number: 13798/6156, EBAMO377. Unpublished study prepared by Springborn Smithers Laboratories. 89 p. 46816947 Kern, M; Lam, C. (2004) Early Life Stage Toxicity of NNI 0001 Technical to the Fathead Minnow (Pimephales promelas) Under Flow- Through Conditions. Project Number: EBAMX005, 200995, AS841201. Unpublished study prepared by Bayer Corp. 86 p. 72-5 Life cycle fish MRID Citation Reference 46816948 Cafarella, M. (2005) NNI-0001 - The Full Life-Cycle Toxicity Test with Fathead Minnow (Pimphales promelas). Project Number: 13798/6155, EBAM0393. Unpublished study prepared by Springborn Smithers Laboratories. 141 p. 72-6 Aquatic org. accumulation MRID Citation Reference 46816949 Dorgerloh, M.; Weber, E. (2005) (Carbon 14)-NNI-0001- Bioconcentration and Biotransformation in Fish (Lepomis macrochirus). Project Number: DOM/23026, E/244/2330/8. Unpublished study prepared by Bayer Ag, Institute of Product Info. & Residue Anal. 156 p. 122-1 Seed Germination/Seedline Emergence and Vegetable Vigor MRID Citation Reference ------- 46817036 Christ, M.; Lam, C. (2005) Tier I Seedling Emergence and Vegetative Vigor: Nontarget Phytotoxicity Study Using NNI-0001 480SC. Project Number: 201376, EBAMX007, EBAM0367. Unpublished study prepared by Bayer Corp. 62 p. 123-1 Seed germination/seedling emergence and vegitative vigor M RID Citation Reference 46817038 Christ, M.; Lam, C. (2006) Tier II Seedling Emergence: Nontarget Phytotoxicity Study using NNI-0001 WG24. Project Number: EBAMX049. Unpublished study prepared by Bayer Corp. 32 p. 123-2 Aquatic plant growth MRID Citation Reference 46817039 Kern, M.; Banman, C.; Lam, C. (2004) Toxicity of NNI 0001 Techncial to Duckweed (Lemna gibba G3) Under Static-Renewal Conditions. Project Number: EBAMX010, AS883701, 200604. Unpublished study prepared by Bayer Corp. 41 p. 132-1 Dissipation of Dislodgeable Foliar & Soil Residues MRID Citation Reference 46817245 Fischer, D. (2006) NNI-0001 480 SC - Dislodgeable Foliar Residue on Sweet Corn and Grape Plant Foliage: Final Report. Project Number: RAAMY004, AM001/05DA, AM002/05D. Unpublished study prepared by Bayer Corp. 494 p. 161-1 Hydrolysis MRID Citation Reference 46816907 Yamashita, A. (2001) Hydrolysis Study of NNI-0001: Final Report. Project Number: LSRC/A01/078A, GC/03, 01/0034. Unpublished study prepared by Nihon Nohyaku Co., Ltd. 56 p. 161-2 Photodegradation-water MRID Citation Reference 46816908 Motoba, K. (2005) Study on Aqueous Photolysis of NNI-0001: Final Report (Amended II). Project Number: GC/03, LSRC/A01/128A, 01/0036. Unpublished study prepared by Nihon Nohyaku Co., Ltd. 88 p. ------- 161-3 Photodegradation-soil MRID Citation Reference 46816909 Shepler, K. (2004) Photodegradation of [(Carbon 14)]NNI-0001 in/on Soil by Artificial Light. Project Number: 1050W/1, 1050W. Unpublished study prepared by PTRL West, Inc. 141 p. 162-1 Aerobic soil metabolism MRID Citation Reference 46816910 Babczinski, P.; Eberhardt, R. (2004) NNI-0001: Aerobic Soil Degradation/Metabolism in Four Different Soils. Project Number: MEF/04/280, M1251206/7, M/125/1206/7. Unpublished study prepared by Bayer Ag, Institute of Product Info. & Residue Anal. 123 p. 46816911 Fliege, R. (2004) [Phthalic Acid Ring-UL-(Carbon 14)]-and [Aniline Ring-UL-(Carbon 14)]-NNI-0001-des-iodo: Aerobic Soil Metabolism in Four Soils. Project Number: M1251289/8, MEF/04/388, M/125/1289/5. Unpublished study prepared by Bayer Ag, Institute of Product Info. & Residue Anal. 114 p. 162-2 Anaerobic soil metabolism MRID Citation Reference 46816912 Hellpointner, E. (2004) Anaerobic Degradation/Metabolism of NNI- 0001 in Soil. Project Number: M1261225/9, MEF/04/067, M/l 26/1225/9. Unpublished study prepared by Bayer Ag, Institute of Product Info. & Residue Anal. 56 p. 162-3 Anaerobic aquatic metab. MRID Citation Reference 46816914 Mathew, A. (2005) [Phthalic Acid Ring-UL-(Carbon 14)]NNI-0001: Anaerobic Aquatic Metabolism. Project Number: AS042401, MEAM6026. Unpublished study prepared by Bayer Corp. 72 p. 163-1 Leach/adsorp/desorption MRID Citation Reference 46816905 Babczinski, P.; Heinemann, O. (2004) Adsorption/Desorption of NNI- 0001 on Soils. Project Number: M1311243/5, MR/201/03, M/l31/1243/5. Unpublished study prepared by Bayer Ag, Institute of Product Info. & Residue Anal. 75 p. ------- 46816906 Volkel, W. (2005) Adsoprtion/Desorption of [(Carbon 14)]-NNI-001- DES-IODO on Soils. Project Number: 855843. Unpublished study prepared by RCC Umweltchemie Ag. 108 p. 164-1 Terrestrial field dissipation MRID Citation Reference 46816916 Lee, R. (2006) Terrestrial Field Dissipation of NNI-0001 in Mississippi Soil, 2003. Project Number: 03EFAMY002, AS022102, AM/001/S04/01. Unpublished study prepared by Bayer Corp., A & L Great Lakes Laboratories and Bayer CropScience Mississippi Field Station. 186 p. 46816917 Lee, R. (2006) Terrestrial Field Dissipation of NNI-0001 in Washington Soil, 2003. Project Number: 03EFAMY003, AS022103, AM/001/S04/01. Unpublished study prepared by Bayer Corp., A & L Great Lakes Laboratories and Agvise Inc. 192 p. 165-4 Bioaccumulation in fish MRID Citation Reference 46816949 Dorgerloh, M; Weber, E. (2005) (Carbon 14)-NNI-0001- Bioconcentration and Biotransformation in Fish (Lepomis macrochirus). Project Number: DOM/23026, E/244/2330/8. Unpublished study prepared by Bayer Ag, Institute of Product Info. & Residue Anal. 156 p. 171-11 Tobacco Uses: Total Residues and Pyrolysis Products MRID Citation Reference 46817244 Ponte, M.; Schick, M. (2006) Tobacco Pyrolysis of [14-Carbon]NNI- 0001. Project Number: 1426W/1, 1426W, RAAMX049. Unpublished study prepared by PTRL West, Inc. 94 p. 830.1550 Product Identity and composition MRID Citation Reference 46816901 Fontaine, L. (2006) Product Chemistry of NNI-0001 Technical. Project Number: BR/2485, VB1/2005/0013501, ANR/07406. Unpublished study prepared by Bayer Corp and Bayer Ag, Institute of Product Info. & Residue Anal. 474 p. 46816903 Frank, J. (2006) Product Chemistry of NNI-001 480 SC. Project Number: ANR/05806, 14/1050/5280, 2001/0054102/02E. Unpublished study prepared by Bayer Corp, Bayer Ag, Institute of Product Info. & ------- Residue Anal, and Bayer Ag Institut fuer Ruckstands-Analytik. 93 p. 46816904 Frank, J. (2006) Product Chemistry of NNI-0001 24 WG. Project Number: ANR/06406, ANR/06606, ANR/06706. Unpublished study prepared by Bayer Corp and Bayer Ag, Institute of Product Info. & Residue Anal, and Bayer Ag Institut fuer Ruckstands-Analytik. 155 p. 830.1600 Description of materials used to produce the product MRID Citation Reference 46816901 Fontaine, L. (2006) Product Chemistry of NNI-0001 Technical. Project Number: BR/2485, VB1/2005/0013501, ANR/07406. Unpublished study prepared by Bayer Corp and Bayer Ag, Institute of Product Info. & Residue Anal. 474 p. 46816903 Frank, J. (2006) Product Chemistry of NNI-001 480 SC. Project Number: ANR/05806, 14/1050/5280, 2001/0054102/02E. Unpublished study prepared by Bayer Corp, Bayer Ag, Institute of Product Info. & Residue Anal, and Bayer Ag Institut fuer Ruckstands-Analytik. 93 p. 46816904 Frank, J. (2006) Product Chemistry of NNI-0001 24 WG. Project Number: ANR/06406, ANR/06606, ANR/06706. Unpublished study prepared by Bayer Corp and Bayer Ag, Institute of Product Info. & Residue Anal, and Bayer Ag Institut fuer Ruckstands-Analytik. 155 p. 830.1620 Description of production process MRID Citation Reference 46816901 Fontaine, L. (2006) Product Chemistry of NNI-0001 Technical. Project Number: BR/2485, VB 1/2005/0013501, ANR/07406. Unpublished study prepared by Bayer Corp and Bayer Ag, Institute of Product Info. & Residue Anal. 474 p. 46816903 Frank, J. (2006) Product Chemistry of NNI-001 480 SC. Project Number: ANR/05806, 14/1050/5280, 2001/0054102/02E. Unpublished study prepared by Bayer Corp, Bayer Ag, Institute of Product Info. & Residue Anal, and Bayer Ag Institut fuer Ruckstands-Analytik. 93 p. 830.1650 Description of formulation process MRID Citation Reference 46816903 Frank, J. (2006) Product Chemistry of NNI-001 480 SC. Project Number: ANR/05806, 14/1050/5280, 2001/0054102/02E. Unpublished study prepared by Bayer Corp, Bayer Ag, Institute of Product Info. & Residue Anal, and Bayer Ag Institut fuer Ruckstands-Analytik. 93 p. ------- 46816904 Frank, J. (2006) Product Chemistry of NNI-0001 24 WG. Project Number: ANR/06406, ANR/06606, ANR/06706. Unpublished study prepared by Bayer Corp and Bayer Ag, Institute of Product Info. & Residue Anal, and Bayer Ag Institut fuer Ruckstands-Analytik. 155 p. 830.1670 Discussion of formation of impurities MRID Citation Reference 46816901 Fontaine, L. (2006) Product Chemistry of NNI-0001 Technical. Proj ect Number: BR/2485, VB1/2005/0013501, ANR/07406. Unpublished study prepared by Bayer Corp and Bayer Ag, Institute of Product Info. & Residue Anal. 474 p. 46816903 Frank, J. (2006) Product Chemistry of NNI-001 480 SC. Project Number: ANR/05806, 14/1050/5280, 2001/0054102/02E. Unpublished study prepared by Bayer Corp, Bayer Ag, Institute of Product Info. & Residue Anal, and Bayer Ag Institut fuer Ruckstands-Analytik. 93 p. 46816904 Frank, J. (2006) Product Chemistry of NNI-0001 24 WG. Project Number: ANR/06406, ANR/06606, ANR/06706. Unpublished study prepared by Bayer Corp and Bayer Ag, Institute of Product Info. & Residue Anal, and Bayer Ag Institut fuer Ruckstands-Analytik. 155 p. 830.1700 Preliminary analysis MRID Citation Reference 46816901 Fontaine, L. (2006) Product Chemistry of NNI-0001 Technical. Project Number: BR/2485, VB 1/2005/0013501, ANR/07406. Unpublished study prepared by Bayer Corp and Bayer Ag, Institute of Product Info. & Residue Anal. 474 p. 830.1750 Certified limits MRID Citation Reference 46816901 Fontaine, L. (2006) Product Chemistry of NNI-0001 Technical. Project Number: BR/2485, VB 1/2005/0013501, ANR/07406. Unpublished study prepared by Bayer Corp and Bayer Ag, Institute of Product Info. & Residue Anal. 474 p. 46816903 Frank, J. (2006) Product Chemistry of NNI-001 480 SC. Project Number: ANR/05806,14/1050/5280, 2001/0054102/02E. Unpublished study prepared by Bayer Corp, Bayer Ag, Institute of Product Info. & Residue Anal, and Bayer Ag Institut fuer Ruckstands-Analytik. 93 p. 46816904 Frank, J. (2006) Product Chemistry of NNI-0001 24 WG. Project Number: ANR/06406, ANR/06606, ANR/06706. Unpublished study ------- prepared by Bayer Corp and Bayer Ag, Institute of Product Info. & Residue Anal, and Bayer Ag Institut fuer Ruckstands-Analytik. 155 p. 830.1800 Enforcement analytical method MRID Citation Reference 46816901 Fontaine, L. (2006) Product Chemistry of NNI-0001 Technical. Project Number: BR/2485, VB1/2005/0013501, ANR/07406. Unpublished study prepared by Bayer Corp and Bayer Ag, Institute of Product Info. & Residue Anal. 474 p. 46816903 Frank, J. (2006) Product Chemistry of NNI-001 480 SC. Project Number: ANR/05806, 14/1050/5280, 2001/0054102/02E. Unpublished study prepared by Bayer Corp, Bayer Ag, Institute of Product Info. & Residue Anal, and Bayer Ag Institut fuer Ruckstands-Analytik. 93 p. 46816904 Frank, J. (2006) Product Chemistry of NNI-0001 24 WG. Project Number: ANR/06406, ANR/06606, ANR/06706. Unpublished study prepared by Bayer Corp and Bayer Ag, Institute of Product Info. & Residue Anal, and Bayer Ag Institut fuer Ruckstands-Analytik. 155 p. 830.6302 Color M RID Citation Reference 46816902 Folsom, B. (2005) Product Chemistry of NNI-0001 Technical: (Final Report). Project Number: 608/58, GE/03/01/0008, LSRC/A01/012A. Unpublished study prepared by Bayer Corp, Bayer Ag, Institute of Product Info. & Residue Anal, and Covance Laboratories, Ltd. 287 p. 46816903 Frank, J. (2006) Product Chemistry of NNI-001 480 SC. Project Number: ANR/05806, 14/1050/5280, 2001/0054102/02E. Unpublished study prepared by Bayer Corp, Bayer Ag, Institute of Product Info. & Residue Anal, and Bayer Ag Institut fuer Ruckstands-Analytik. 93 p. 830.6303 Physical state MRID Citation Reference 46816902 Folsom, B. (2005) Product Chemistry of NNI-0001 Technical: (Final Report). Project Number: 608/58, GE/03/01/0008, LSRC/A01/012A. Unpublished study prepared by Bayer Corp, Bayer Ag, Institute of Product Info. & Residue Anal, and Covance Laboratories, Ltd. 287 p. 46816903 Frank, J. (2006) Product Chemistry of NNI-001 480 SC. Project Number: ANR/05806, 14/1050/5280, 2001/0054102/02E. Unpublished study prepared by Bayer Corp, Bayer Ag, Institute of Product Info. & Residue Anal, and Bayer Ag Institut fuer Ruckstands-Analytik. 93 p. ------- 830.6304 MRID Odor Citation Reference 46816902 46816903 830.6313 metal ions MRID Folsom, B. (2005) Product Chemistry of NNI-0001 Technical: (Final Report). Project Number: 608/58, GE/03/01/0008, LSRC/A01/012A. Unpublished study prepared by Bayer Corp, Bayer Ag, Institute of Product Info. & Residue Anal, and Covance Laboratories, Ltd. 287 p. Frank, J. (2006) Product Chemistry of NNI-001 480 SC. Project Number: ANR/05806, 14/1050/5280, 2001/0054102/02E. Unpublished study prepared by Bayer Corp, Bayer Ag, Institute of Product Info. & Residue Anal, and Bayer Ag Institut fuer Ruckstands-Analytik. 93 p. Stability to sunlight, normal and elevated temperatures, metals, and Citation Reference 46816902 Folsom, B. (2005) Product Chemistry of NNI-0001 Technical: (Final Report). Project Number: 608/58, GE/03/01/0008, LSRC/A01/012A. Unpublished study prepared by Bayer Corp, Bayer Ag, Institute of Product Info. & Residue Anal, and Covance Laboratories, Ltd. 287 p. 830.6314 Oxidizing or reducing action MRID Citation Reference 46816903 Frank, J. (2006) Product Chemistry of NNI-001 480 SC. Project Number: ANR/05806, 14/1050/5280, 2001/0054102/02E. Unpublished study prepared by Bayer Corp, Bayer Ag, Institute of Product Info. & Residue Anal, and Bayer Ag Institut fuer Ruckstands-Analytik. 93 p. 830.6315 Flammability MRID Citation Reference 46816903 Frank, J. (2006) Product Chemistry of NNI-001 480 SC. Project Number: ANR/05806, 14/1050/5280, 2001/0054102/02E. Unpublished study prepared by Bayer Corp, Bayer Ag, Institute of Product Info. & Residue Anal, and Bayer Ag Institut fuer Ruckstands-Analytik. 93 p. 830.6316 Explodability MRID Citation Reference 46816902 Folsom, B. (2005) Product Chemistry of NNI-0001 Technical: (Final Report). Project Number: 608/58, GE/03/01/0008, LSRC/A01/012A. ------- Unpublished study prepared by Bayer Corp, Bayer Ag, Institute of Product Info. & Residue Anal, and Covance Laboratories, Ltd. 287 p. 830.6317 Storage stability of product MRID Citation Reference 46816903 Frank, J. (2006) Product Chemistry of NNI-001 480 SC. Project Number: ANR/05806, 14/1050/5280, 2001/0054102/02E. Unpublished study prepared by Bayer Corp, Bayer Ag, Institute of Product Info. & Residue Anal, and Bayer Ag Institut fuer Ruckstands-Analytik. 93 p. 830.6320 Corrosion characteristics MRID Citation Reference 46816903 Frank, J. (2006) Product Chemistry of NNI-001 480 SC. Project Number: ANR/05806, 14/1050/5280, 2001/0054102/02E. Unpublished study prepared by Bayer Corp, Bayer Ag, Institute of Product Info. & Residue Anal, and Bayer Ag Institut fuer Ruckstands-Analytik. 93 p. 830.7000 pH of water solutions or suspensions MRID Citation Reference 46816902 Folsom, B. (2005) Product Chemistry of NNI-0001 Technical: (Final Report). Project Number: 608/58, GE/03/01/0008, LSRC/A01/012A. Unpublished study prepared by Bayer Corp, Bayer Ag, Institute of Product Info. & Residue Anal, and Covance Laboratories, Ltd. 287 p. 46816903 Frank, J. (2006) Product Chemistry of NNI-001 480 SC. Project Number: ANR/05806, 14/1050/5280, 2001/0054102/02E. Unpublished study prepared by Bayer Corp, Bayer Ag, Institute of Product Info. & Residue Anal, and Bayer Ag Institut fuer Ruckstands-Analytik. 93 p. 830.7050 UV/Visible absorption MRID Citation Reference 46816902 Folsom, B. (2005) Product Chemistry of NNI-0001 Technical: (Final Report). Project Number: 608/58, GE/03/01/0008, LSRC/A01/012A. Unpublished study prepared by Bayer Corp, Bayer Ag, Institute of Product Info. & Residue Anal, and Covance Laboratories, Ltd. 287 p. 830.7100 Viscosity MRID Citation Reference ------- 46816903 Frank, J. (2006) Product Chemistry of NNI-001 480 SC. Project Number: ANR/05806, 14/1050/5280, 2001/0054102/02E. Unpublished study prepared by Bayer Corp, Bayer Ag, Institute of Product Info. & Residue Anal, and Bayer Ag Institut fuer Ruckstands-Analytik. 93 p. 830.7200 Melting point/melting range MRID Citation Reference 46816902 Folsom, B. (2005) Product Chemistry of NNI-0001 Technical: (Final Report). Project Number: 608/58, GE/03/01/0008, LSRC/A01/012A. Unpublished study prepared by Bayer Corp, Bayer Ag, Institute of Product Info. & Residue Anal, and Covance Laboratories, Ltd. 287 p. 830.7300 Density/relative density MRID Citation Reference 46816902 Folsom, B. (2005) Product Chemistry of NNI-0001 Technical: (Final Report). Project Number: 608/58, GE/03/01/0008, LSRC/A01/012A. Unpublished study prepared by Bayer Corp, Bayer Ag, Institute of Product Info. & Residue Anal, and Covance Laboratories, Ltd. 287 p. 46816903 Frank, J. (2006) Product Chemistry of NNI-001 480 SC. Project Number: ANR/05806, 14/1050/5280, 2001/0054102/02E. Unpublished study prepared by Bayer Corp, Bayer Ag, Institute of Product Info. & Residue Anal, and Bayer Ag Institut fuer Ruckstands-Analytik. 93 p. 830.7370 Dissociation constant in water MRID Citation Reference 46816902 Folsom, B. (2005) Product Chemistry of NNI-0001 Technical: (Final Report). Project Number: 608/58, GE/03/01/0008, LSRC/A01/012A. Unpublished study prepared by Bayer Corp, Bayer Ag, Institute of Product Info. & Residue Anal, and Covance Laboratories, Ltd. 287 p. 830.7560 Partition coefficient (n-octanol/water), generator column method MRID Citation Reference 46816902 Folsom, B. (2005) Product Chemistry of NNI-0001 Technical: (Final Report). Project Number: 608/58, GE/03/01/0008, LSRC/A01/012A. Unpublished study prepared by Bayer Corp, Bayer Ag, Institute of Product Info. & Residue Anal, and Covance Laboratories, Ltd. 287 p. 830.7840 Water solubility: Column elution method, shake flask method MRID Citation Reference ------- 46816902 Folsom, B. (2005) Product Chemistry of NNI-0001 Technical: (Final Report). Project Number: 608/58, GE/03/01/0008, LSRC/A01/012A. Unpublished study prepared by Bayer Corp, Bayer Ag, Institute of Product Info. & Residue Anal, and Covance Laboratories, Ltd. 287 p. 830.7950 Vapor pressure MRID Citation Reference 46816902 Folsom, B. (2005) Product Chemistry of NNI-0001 Technical: (Final Report). Project Number: 608/58, GE/03/01/0008, LSRC/A01/012A. Unpublished study prepared by Bayer Corp, Bayer Ag, Institute of Product Info. & Residue Anal, and Covance Laboratories, Ltd. 287 p. 835.1240 Soil column leaching MRID Citation Reference 46816906 Volkel, W. (2005) Adsoprtion/Desorption of [(Carbon 14)]-NNI-001 - DES-IODO on Soils. Project Number: 855843. Unpublished study prepared by RCC Umweltchemie Ag. 108 p. 835.2120 Hydrolysis of parent and degradates as a function of pH at 25 C MRID Citation Reference 46816907 Yamashita, A. (2001) Hydrolysis Study of NNI-0001: Final Report. Project Number: LSRC/A01/078A, GC/03, 01/0034. Unpublished study prepared by Nihon Nohyaku Co., Ltd. 56 p. 835.2240 Direct photolysis rate of parent and degradates in water MRID Citation Reference 46816908 Motoba, K. (2005) Study on Aqueous Photolysis of NNI-0001: Final Report (Amended II). Project Number: GC/03, LSRC/A01/128A, 01/0036. Unpublished study prepared by Nihon Nohyaku Co., Ltd. 88 p. 835.2410 Photodegradation of parent and degradates in soil MRID Citation Reference 46816909 Shepler, K. (2004) Photodegradation of [(Carbon 14)]NNI-0001 in/on Soil by Artificial Light. Project Number: 1050W/1, 1050W. Unpublished study prepared by PTRL West, Inc. 141 p. ------- 835.4100 MRID Aerobic soil metabolism Citation Reference 46816910 Babczinski, P.; Eberhardt, R. (2004) NNI-0001: Aerobic Soil Degradation/Metabolism in Four Different Soils. Project Number: MEF/04/280, Ml251206/7, M/l25/1206/7. Unpublished study prepared by Bayer Ag, Institute of Product Info. & Residue Anal. 123 p. 46816911 Fliege, R. (2004) [Phthalic Acid Ring-UL-(Carbon 14)]-and [Aniline Ring-UL-(Carbon 14)]-NNI-0001-des-iodo: Aerobic Soil Metabolism in Four Soils. Project Number: M1251289/8, MEF/04/388, M/125/1289/5. Unpublished study prepared by Bayer Ag, Institute of Product Info. & Residue Anal. 114 p. 835.4200 Anaerobic soil metabolism MRID Citation Reference 46816912 Hellpointner, E. (2004) Anaerobic Degradation/Metabolism of NNI- 0001 in Soil. Project Number: M1261225/9, MEF/04/067, M/126/1225/9. Unpublished study prepared by Bayer Ag, Institute of Product Info. & Residue Anal. 56 p. 835.4300 Aerobic aquatic metabolism MRID Citation Reference 46816913 Sneikus, J. (2004) Aerobic Degradation and Metabolism of NNI-0001 in the Water/Sediment System. Project Number: Ml511248/2, MEF/414/03, M/151/1248/2. Unpublished study prepared by Bayer Ag, Institute of Product Info. & Residue Anal. 91 p. 835.4400 Anaerobic aquatic metabolism MRID Citation Reference 46816914 Mathew, A. (2005) [Phthalic Acid Ring-UL-(Carbon 14)]NNI-0001: Anaerobic Aquatic Metabolism. Project Number: AS042401, MEAM6026. Unpublished study prepared by Bayer Corp. 72 p. 835.6100 Terrestrial field dissipation MRID Citation Reference 46816915 Lee, R. (2006) Terrestrial Field Dissipation of NNI-0001 in California Soil, 2003. Project Number: 03EFAMY001, AS022101. Unpublished study prepared by Bayer Corp., A & L Great Lakes Laboratories and ------- Bayer CropScience. 187 p. 46816916 Lee, R. (2006) Terrestrial Field Dissipation of NNI-0001 in Mississippi Soil, 2003. Project Number: 03EFAMY002, AS022102, AM/001/S04/01. Unpublished study prepared by Bayer Corp., A & L Great Lakes Laboratories and Bayer CropScience Mississippi Field Station. 186 p. 46816917 Lee, R. (2006) Terrestrial Field Dissipation of NNI-0001 in Washington Soil, 2003. Project Number: 03EFAMY003, AS022103, AM/001/S04/01. Unpublished study prepared by Bayer Corp., A & L Great Lakes Laboratories and Agvise Inc. 192 p. 835.6200 Aquatic field dissipation MRID Citation Reference 46817033 Sommer, H. (2002) Method for the Determination of NNI-0001 in Test Water from Aquatic Toxicity Test by HPLC-UV. Project Number: MR/391/02, 00789. Unpublished study prepared by Bayer Ag, Institute of Product Info. & Residue Anal. 12 p. 850.1010 Aquatic invertebrate acute toxicity, test, freshwater daphnids MRID Citation Reference 46816930 Dorgerloh, M. (2006) Acute Toxicity of NNI-0001 (tech.) in Water Fleas (Daphnia magna). Project Number: DOM/22041, E/320/2283/0, MR/391/02. Unpublished study prepared by Bayer Ag, Institute of Product Info. & Residue Anal. 39 p. 46816931 Dorgerloh, M. (2003) Acute Toxicity of NNI-0001 SC 480 to Water Fleas (Daphnia magna). Project Number: E/320/2284/1, DOM/22042. Unpublished study prepared by Bayer Ag, Institute of Product Info. & Residue Anal. 43 p. 46816932 Dorgerloh, M. (2005) Acute Toxicity of NNI-0001 WG 24 to the Waterflea Daphnia magna in a Static Laboratory Test System. Project Number: P/684/027017, MR/188/02, EBAMX018. Unpublished study prepared by Bayer Ag, Institute of Product Info. & Residue Anal. 58 p. 46816933 Dorgerloh, M. (2004) Acute Toxicity of NNI-0001-des-iodo to the Waterflea Daphnia magna. Project Number: DOM/23055, MR/029/04, E/3 20/2503/5. Unpublished study prepared by Bayer Ag, Institute of Product Info. & Residue Anal. 43 p. 46816934 Dorgerloh, M. (2005) Acute Toxicity of NNI-0001 SC 480 in the Waterflea Dahnia magna Under Different Feeding Conditions in a Static Laboratory Test System. Project Number: E/320/2849/8, EBAMX028, ------- MR/188/02. Unpublished study prepared by Bayer Ag, Institute of Product Info. & Residue Anal. 59 p. 850.1025 Oyster acute toxicity test (shell deposition) MRID Citation Reference 4681693 5 Dionne, E. (2004) NNI-0001 -Acute Toxicity to Eastern Oysters (Crassostrea Virginia) Under Flow-Through Conditions. Project Number: AS881501, 13798/613, EBAM0380. Unpublished study prepared by Springborn Smithers Laboratories. 53 p. 850.1035 Mysid acute toxicity test MRID Citation Reference 46816936 Dionne, E. (2004) NNI-0001 - Acute Toxicity to Mysids (Americamysis bahia) Under Static Conditions. Project Number: 13798/6131, AS883101, EBAMO376. Unpublished study prepared by Springborn Smithers Laboratories. 49 p. 850.1075 Fish acute toxicity test, freshwater and marine MRID Citation Reference 46816937 Kern, M; DeHann, R. (2004) Acute Toxicity of NNI 0001 Technical to the Fathead Minnow (Pimephales promelas) Under Static Conditions. Project Number: EBAM0390/AS811201, 200713. Unpublished study prepared by Bayer Corp. 42 p. 46816938 Banman, C.; Kern, M.; Lam, C. (2004) Acute Toxicity of NNI 0001 Technical to the Sheepshead Minnow (Cyprinodon variegatus) Under Static Conditions. Project Number: 200992, EBAM0370. Unpublished study prepared by Bayer Corp. 31 p. 46816939 Dorgerloh, M. (2003) Acute Toxicity of NNI-0001 (Tech.) to Fish (Lepomis macrochirus). Project Number: E/280/2291/4, DOM/22043. Unpublished study prepared by Bayer Ag, Institute of Product Info. & Residue Anal. 49 p. 46816940 Dorgerloh, M. (2003) Acute Toxicity of NNI-0001 (Tech.) to Fish (Oncorhynchus mykiss). Project Number: DOM/22044, E/280/2292/5. Unpublished study prepared by Bayer Ag, Institute of Product Info. & Residue Anal. 75 p. 46816941 Yamazaki, I. (2003) Acute Toxicity Test of NNI-0001 to Carp. Project Number: GC/01, LSRC/T02/126A, 02/0145. Unpublished study prepared by Nihon Nohyaku Co., Ltd. 30 p. ------- 46816942 Dorgerloh, M. (2003) Acute Toxicity of NNI-0001 480 SC to Fish (Lepomis macrochirus). Project Number: E/280/2352/2, DOM/22081, 00789. Unpublished study prepared by Bayer Ag, Institute of Product Info. & Residue Anal. 42 p. 46816943 Dorgerloh, M. (2003) Acute Toxicity of NNI-0001 480 SC to Fish (Oncorhynchus mykiss). Project Number: E/280/2354/4, DOM/22082, 00789. Unpublished study prepared by Bayer Ag, Institute of Product Info. & Residue Anal. 42 p. 850.1300 Daphnid chronic toxicity test MRID Citation Reference 46816944 Dorgerloh, M. (2003) Influence of NNI-0001 (Tech.) on Development and Reproductive Output of the Waterflea Daphnia magna in a Static Renewal Laboratory Test System. Project Number: E/321/2267/3, DOM/22035, 00760. Unpublished study prepared by Bayer Ag, Institute of Product Info. & Residue Anal. 88 p. 46816945 Dorgerloh, M. (2003) Influence of NNI-0001 SC 480 on Development and Reproductive Output of the Waterflea Daphnia magna in a Static Renewal Laboratory Test System. Project Number: E/321/2372/0, DOM/23001, 00760. Unpublished study prepared by Bayer Ag, Institute of Product Info. & Residue Anal. 81 p. 850.1400 Fish early-life stage toxicity test MRID Citation Reference 46816946 Putt, A. (2005) NNI-0001 - Life-Cycle Toxicity Test with Mysids (Americamysis bahia). Project Number: 13798/6156, EBAMO377. Unpublished study prepared by Springborn Smithers Laboratories. 89 p. 46816947 Kern, M; Lam, C. (2004) Early Life Stage Toxicity of NNI 0001 Technical to the Fathead Minnow (Pimephales promelas) Under Flow- Through Conditions. Project Number: EBAMX005, 200995, AS841201. Unpublished study prepared by Bayer Corp. 86 p. 850.1500 Fish life cycle toxicity MRID Citation Reference 46816948 Cafarella, M. (2005) NNI-0001 - The Full Life-Cycle Toxicity Test with Fathead Minnow (Pimphales promelas). Project Number: 13798/6155, EBAM0393. Unpublished study prepared by Springborn Smithers Laboratories. 141 p. ------- 850.1730 MRID Fish BCF Citation Reference 46816949 Dorgerloh, M; Weber, E. (2005) (Carbon 14)-NNI-0001- Bioconcentration and Biotransformation in Fish (Lepomis macrochirus). Project Number: DOM/23026, E/244/2330/8. Unpublished study prepared by Bayer Ag, Institute of Product Info. & Residue Anal. 156 p. 850.1850 Aquatic food chain transfer MRID Citation Reference 46817001 Weber, E.; Dorgerloh, M. (2005) [Aniline-UL-(Carbon 14)]-NNL-0001- desidio: Bioconcentration, Depuration and Determination of Residues in Fish (Lepomis macrochirus). Project Number: DOM/24023, E/244/2683/9. Unpublished study prepared by Bayer Ag, Institute of Product Info. & Residue Anal. 111 p. 850.1950 Field testing for aquatic organisms MRID Citation Reference 46817002 Heimbach, F.; Arnold, M.; Brumhard, B. (2005) Biological Effects and Fate of NNI-0001 SC 480 in Outdoor Mesocosm Ponds. Project Number: HBF/BT/06, E/413/2434/1. Unpublished study prepared by Bayer Ag, Institute of Product Info. & Residue Anal, and Fraunhofer Institute for Molecular. 349 p. 850.2100 Avian acute oral toxicity test MRID Citation Reference 46817003 Barfknecht, R. (2003) Acute Oral Toxicity for Northern Bobwhite Quail (Colinus virginianus): NNI-0001. Project Number: E/204/2295/4, BAR/LD/044. Unpublished study prepared by Bayer Ag, Institute of Product Info. & Residue Anal. 32 p. 46817004 Barfknect, R. (2004) Acute Oral Toxicity for Bobwhite Quail (Colinus virginianus): NNI-0001 SC 480. Project Number: E/204/2717/3, BAR/LD/057. Unpublished study prepared by Bayer Ag, Institute of Product Info. & Residue Anal. 24 p. 850.2200 Avian dietary toxicity test MRID Citation Reference 46817005 Bowers, L. (2005) Technical NNI 0001: A Subacute Dietary LC50 with ------- Mallards. Project Number: AS720801, 201263. Unpublished study prepared by Bayer Corp. 41 p. 46817006 Barfknecht, R. (2003) NNI-0001 Tech.: 5-Day-Dietary LC50 Bobwhite Quail (Colinus virginianus). Project Number: BAR/LC014, E/295/2268/4. Unpublished study prepared by Bayer Ag, Institute of Product Info. & Residue Anal. 33 p. 850.2300 Avian reproduction test MRID Citation Reference 46817008 Bowers, L. (2005) Effect of Technical NNI 0001 on Northern Bobwhite Reproduction. Project Number: AS741701, 201138. Unpublished study prepared by Bayer Corp. 143 p. 850.2500 Field testing for terrestrial wildlife MRID Citation Reference 46817012 Nguyen, D.; Gosch, H. (2005) Effect on Bombus terrestris of NNI 0001 WG 24 and Decis Protech used at the Maximum Dose in Greenhouse Tomatoes. Project Number: 201492. Unpublished study prepared by Bayer Cropscience Gmbh. 36 p. 46817024 Wolf, C. (2006) Residues in Arthropod Prey of Birds and Mammals After the Application of NNI 0001 SC 480 (Active Substance NNI 0001) in a German Vineyard: Final Report. Project Number: WFC/FS/011, E/308/2687/4. Unpublished study prepared by Bayer Ag, Institute of Product Info. & Residue Anal. 89 p. 46817027 Frommholz, U. (2005) NNI-0001 SC 480: Influence on the Reproduction of the Collembola species Folsomia Candida Test in Artificial Soil. Project Number: E/314/2/870/5, LKC/COLL/40/05. Unpublished study prepared by Bayer Ag, Institute of Product Info. & Residue Anal. 26 p. 850.3020 Honey bee acute contact toxicity MRID Citation Reference 46817009 Barth, M. (2002) Acute Toxicity of NNI-0001 a.i. to the Honeybee Apis Mellifera L. under Laboratory Conditions: Final Report. Project Number: 02/10/48/035. Unpublished study prepared by Biochem Agrar, Lab fuer Biologische und Chemische. 30 p. 46817010 Barth, M. (2002) Acute Toxicity of NNI-0001 SC 480 to the Honeybee Apis Mellifera L. under Laboratory Conditions: Final Report. Project Number: 01/10/48/034, 02/10/48/034. Unpublished study prepared by Biochem Agrar, Lab fuer Biologische und Chemische. 29 p. ------- 46817015 Waltersdorfer, A. (2004) Toxicity to the Ladybird Coccinella septempunctata L. (Coleoptera, Coccinellidae) using an Extended Laboratory Test Including Exposure to and Oral Uptake of NNI-0001 SC 480. Project Number: CW03/029. Unpublished study prepared by Bayer Cropscience Gmbh. 27 p. 850.3040 Field testing for pollinators MRID Citation Reference 46817011 Schur, A. (2006) Assessment of Side Effects of NNI-0001 SC 480 on the Honey Bee (Apis mellifera L.) in the Semi-Field: Final Report. Project Number: 20051108/01/BZEU. Unpublished study prepared by GAB Biotechnologie Gmbh. 115 p. 850.4100 Terrestrial plant toxicity, Tier 1 (seeding emergence) MRID Citation Reference 46817034 Nguyen, D.; Gosch, H. (2005) Non-Target Terrestrial Plants: An Evaluation of the Effects of NNI-0001 WG 24 in the Seedling Emergence and Growth Test (Tier 1). Project Number: SE04/14, SE04/14/TIER/1. Unpublished study prepared by Bayer Cropscience Gmbh. 17 p. 46817035 Lechelt-Kunze, C. (2002) NNI-0001 SC 480: Pre - and Post - Emergence Screening for Herbicidal Activity. Project Number: LKC/NTPSCR/05/02. Unpublished study prepared by Bayer Cropscience Gmbh. 14 p. 850.4150 Terrestrial plant toxicity, Tier 1 (vegetative vigor) MRID Citation Reference 46817035 Lechelt-Kunze, C. (2002) NNI-0001 SC 480: Pre - and Post - Emergence Screening for Herbicidal Activity. Project Number: LKC/NTPSCR/05/02. Unpublished study prepared by Bayer Cropscience Gmbh. 14 p. 46817036 Christ, M.; Lam, C. (2005) Tier I Seedling Emergence and Vegetative Vigor: Nontarget Phytotoxicity Study Using NNI-0001 480SC. Project Number: 201376, EBAMX007, EBAM0367. Unpublished study prepared by Bayer Corp. 62 p. 46817037 Nguyen, D.; Gosch, H. (2005) Non-Target Terrestrial Plants: An Evaluation of the Effects of NNI-0001 WG 24 in the Vegetative Vigor Test (Tier 1). Project Number: W04/14, W04/14/TIER/1. Unpublished study prepared by Bayer Cropscience Gmbh. 17 p. ------- 850.4400 Aquatic plant toxicity test using Lemna spp. Tiers I and II MRID Citation Reference 46817039 Kern, M.; Banman, C.; Lam, C. (2004) Toxicity of NNI 0001 Techncial to Duckweed (Lemna gibba G3) Under Static-Renewal Conditions. Project Number: EBAMX010, AS883701, 200604. Unpublished study prepared by Bayer Corp. 41 p. 46817040 Dorgerloh, M. (2005) Pseudokirchneriella subcapitata Growth Inhibition Test with NNI-0001 SC 480. Project Number: DOM/24031, 00789, MR/391/02. Unpublished study prepared by Bayer Ag, Institute of Product Info. & Residue Anal. 53 p. 850.5400 Algal toxicity, Tiers 1 and II MRID Citation Reference 46817041 Yamazaki, I. (2003) Algal Growth Inhibition Test of NNI-0001: Final Report. Project Number: GC/01, 02/0128, LSRCAT02/121A. Unpublished study prepared by Nihon Nohyaku Co., Ltd. 30 p. 860.1000 Background MRID Citation Reference 46817114 Muprhy, J. (2005) NNI-0001 480 SC - Magnitude of the Residue in/on Tobacco. Project Number: RAAMX048. Unpublished study prepared by Bayer Corp., Bayer CropScience Midwest Field Technology Station and Bayer Research Farm. 131 p. 860.1300 Nature of the residue - plants, livestock MRID Citation Reference 46817043 Baker, F.; Kimmel, E.; Estigoy, L. (2002) A Metabolism Study with [(Carbon 14)]-NNI-0001 on Apples. Project Number: 1027W/2, 1027W. Unpublished study prepared b: PTRL West, Inc. and Excel Research Services, Inc. 390 p. 46817044 Motoba, K. (2002) Metabolism Study of NNI-0001 in Cabbage: Final Report (Amended I). Project Number: GB/03, 01/0101, LSRC/M02/011 A. Unpublished study prepared by Nihon Nohyaku Co., Ltd. 83 p. 46817045 Motoba, K. (2005) Metabolism Study of NNI-0001 in Cherry Tomato: Final Report (Amended II). Project Number: GB/03, 01/0069, LSRC/M01/122A. Unpublished study prepared by Nihon Nohyaku Co., ------- Ltd. 97 p. 46817046 Krolski, M; Nguyen, T. (2005) The Metabolism of NNI-0001 in Corn. Project Number: AS041602/MEAMX009, AS041601/MEAMX010. Unpublished study prepared by Bayer Corp. 121 p. 46817047 Weber, H.; Koester, J.; Justus, K. (2005) [Aniline-UL-(Carbon 14)]NNI- 0001: Absorption, Distribution, Excretion, and Metabolism in the Lactating Goat. Project Number: MEF/03/173, M51819123, M/l 81/9123/5. Unpublished study prepared by Bayer Ag, Institute of Product Info. & Residue Anal. 254 p. 46817048 Koester, J.; Justus, K.; Brueckner, H. (2005) [Phthalic-acid-UL-(Carbon 14)]NNI-0001: Absorption, Distribution, Excretion, and Metabolism in the Lactating Goat. Project Number: Ml 1819129, MEF/04/173, M/181/9129/1. Unpublished study prepared by Bayer Ag, Institute of Product Info. & Residue Anal. 185 p. 46817049 Koester, J.; Justus, K. (2004) Metabolism of [Aniline-UL-(Carbon 14)]NNI-0001 in the Laying Hen. Project Number: M81819126, MEF/04/055, M/181/9126/8. Unpublished study prepared by Bayer Ag, Institute of Product Info. & Residue Anal. 158 p. 46817050 Koester, J.; Justus, K.; Brueckner, H. (2005) Metabolism of [Phthalic- Acid-UL-(Carbon 14)]NNI-0001 in the Laying Hen. Project Number: M51819132, MEF/04/159, M/181/9132/5. Unpublished study prepared by Bayer Ag, Institute of Product Info. & Residue Anal. 151 p. 860.1340 Residue analytical method MRID Citation Reference 46816928 Netzband, D.; Yin, J. (2006) Independent Laboratory Validation of "Method 00838 (MR-134/03) for the Determination of NNI-0001 and NNI-0001-des-iodo in Drinking and Surface Water by HPLC-MS/MS". Project Number: RAAMX098, MR/134/03, 000838. Unpublished study prepared by Bayer Corp. 78 p. 46817101 Billian, P.; Wolters, A. (2006) Analytical Method 00816/M002 for the Determination of Residues of NNI-0001 and its Des-iodo Metabolite A- 1 in/on Plant Material by HPLC-MS/MS Using Stable-Labelled Internal Standards. Project Number: P602030522, 00816/M002, MR/121/03. Unpublished study prepared by Bayer Ag, Institute of Product Info. & Residue Anal. 103 p. 46817102 Reiner, H. (2005) Extraction Efficiency Testing of the Residue Method for the Determination of NNI-0001 Residues in Corn Using Aged Radioactive Residues. Project Number: M9991366/3, MEF/04/0465. Unpublished study prepared by Bayer Ag, Institute of Product Info. & ------- Residue Anal. 41 p. 46817103 Class, T. (2005) Independent Laboratory Validation of Method 00816/M001 for the Determination of Residues of NNI-0001 and Its Des-Iodo Metabolite A-l in/on Plant Material by HPLC-MS/MS: Demonstration of a LC/MS/MS Confirmatory Method. Project Number: P/866/G, P612050563, P/B/866/G. Unpublished study prepared by PTRL Europe Gmbh. 50 p. 46817104 Billian, P. (2005) Analytical Method 00912 for the Determination of Residues of NNI-0001 and its Metabolite A14 in/on Muscle, Liver and Kidney, Milk, Fat and Poultry Egg by HPLC-MS/MS. Project Number: MR/149/04, 00912, P603040541. Unpublished study prepared by Bayer Ag, Institute of Product Info. & Residue Anal. 177 p. 46817105 Justus, K.; Brueckner, H. (2005) [Phthalic acid-UL-(Carbon 14)] NNI- 0001 : Extraction Efficiency of the Residue Analytical Method for the Determination of NNI-0001 and NNI-0001-lodophthalimide in Animal Tissues, Milk, and Eggs Using Aged Radioactive Residues. Project Number: M9991432/7, MEF/04/526. Unpublished study prepared by Bayer Ag, Institute of Product Info. & Residue Anal. 65 p. 46817106 Anspach, T. (2005) Independent Laboratory Validation of the Bayer CropScience Method No. 00912 for the Determination of Residues of NNI-001 and its Metabolite A-14 in/on Muscle, Fat and Poultry Egg by HPLC-MS/MS: Final Report. Project Number: BAY/0512V, G05/0019, P683050565. Unpublished study prepared by Dr. Specht and Partner. 100 p. 47263101 Billian, P. (2007) Confirmation Method for Analytical Method 00816/M002 for the Determination of Residues of NNI-001 and its des- iodo Metabolite A-l in/on Plant Material by HPLC-MS/MS Using Stable-Labelled Internal Standards. Project Number: P682070621, MR/07/300, M/290991/01/1. Unpublished study prepared by Bayer CropScience AG. 17 p. 47263102 Rotzoll, N. (2007) Independent Laboratory Validation of the Bayer CropScience Method 00816/M002 for the Determination of NNI-0001 (Flubendiamide) and its Metabolite NNI-001-desiodo in Plant Matrices: Final Report. Project Number: BAY/0705V, G07/0117, P612070622. Unpublished study prepared by Eurofins Analytik GmbH. 72 p. 860.1360 Multiresidue method MRID Citation Reference 46817107 Wilson, T. (2006) Testing of NNI-0001 and Two Metabolites Through the FDA Multiresidue Methods as Described in the FDA Pesticide Analytical Manual (PAM) I, Appendix II, Updated 1/94. Project ------- Number: RAAMY017, 49859. Unpublished study prepared by Analytical Bio-Chemistry Labs., Inc. 95 p. 860.1380 Storage stability data MRID Citation Reference 46817108 Billian, P. (2005) Storage Stability of NNI-0001 in/on Tomato (Fruit), Cotton (Oil), Wheat (Grain), Head Cabbage (Head), Bean (Bean with Pod) and Citrus (Fruit) for 18 Months. Project Number: P642030518, MR/064/03, BCS/RD/D/ROCS. Unpublished study prepared by Bayer Ag, Institute of Product Info. & Residue Anal. 37 p. 46817109 Billian, P. (2005) Storage Stability of NNI-0001 -Des-Iodo in/on Tomato (Fruit), Plant Oil, Wheat (Grain), Head Cabbage (Head), Bean (Bean With Pod) and Citrus (Fruit) for 18 Months. Project Number: P642030520, BCS/RD/D/ROCS, MR/086/03. Unpublished study prepared by Bayer Ag, Institute of Product Info. & Residue Anal. 37 p. 46817110 Murphy, I. (2006) Storage Stability of NNI-0001 and A-l (NNI-0001- Desiodo) in Various Crop Matrices. Project Number: RAAMY002, AM050804B/NNI/A1, AM060207A/34. Unpublished study prepared by Bayer Corp. 250 p. 860.1480 Meat/milk/poultry/eggs MRID Citation Reference 46817111 Billian, P.; Auer, S.; Eberhardt, R. (2005) NNI-0001: Dairy Cattle Feeding Study. Project Number: MR/030/05, P673050562, BCS/RD/D/ROCS. Unpublished study prepared by Bayer Ag, Institute of Product Info. & Residue Anal. 200 p. 46817112 Billian, P.; Eberhardt, R. (2005) NNI-0001: Feeding Study Laying Hens (Gallus gallus domesticus). Project Number: P673050566, BR/031/05, BCS/RD/D/ROCS. Unpublished study prepared by Bayer Ag, Institute of Product Info. & Residue Anal. 292 p. 860.1500 Crop field trials MRID Citation Reference 46817113 Krolski, M.; Harbin, A. (2006) NNI-0001 480 SC - Magnitude of the Residue in/on Field and Sweet Corn. Project Number: RCAMY004. Unpublished study prepared by Bayer Corp., Bayer CropScience Midwest Field Technology Station and Bayer Research Farm. 455 p. 46817114 Muprhy, J. (2005) NNI-0001 480 SC - Magnitude of the Residue in/on Tobacco. Project Number: RAAMX048. Unpublished study prepared by ------- Bayer Corp., Bayer CropScience Midwest Field Technology Station and Bayer Research Farm. 131 p. 46817115 Beedle, E. (2006) NNI-0001 480 SC - Magnitude of the Residue on Cotton. Project Number: RCAMY002. Unpublished study prepared by Bayer Corp., Texas A & M Food Protein Research & and GLP Technologies. 244 p. 46817116 Lenz, C. (2006) NNI-0001 480 SC - Magnitude of the Residue on Grape. Project Number: RCAMY016. Unpublished study prepared by Bayer Corp., Crop Management Strategies, Inc. and A.C.D.S. Research, Inc. 152 p. 46817117 Xu, T.; Mackie, S. (2005) NNI-001 480 SC - Magnitude of the Residue on Pome Fruit (Apple and Pear). Project Number: RCAMY009. Unpublished study prepared by: Bayer Corp., A.C.D.S. Research, Inc. and Ag Research Associates. 354 p. 46817118 Helfrich, K.; Sandra, J.; Mackie, W. (2006) NNI-0001 480 SC - Magnitude of the Residue on Stone Fruit (Crop Group 12: Cherries, Plums, and Peaches). Project Number: RCAMY011. Unpublished study prepared by Bayer Corp., Crop Management Strategies, Inc. and Agsearch. 357 p. 46817119 Pither, K.; Mackie, S. (2006) NNI-0001 480 SC - Magnitude of the Residue on Tree Nuts (Almonds and Pecan). Project Number: RCAMY014. Unpublished study prepared by Bayer Corp., South Texas Ag Research, Inc. and Crop Guard Research, Inc. 245 p. 46817120 Fischer, D. (2005) NNI-0001 24 WG - Magnitude of the Residue in/on Fruiting Vegetables (Crop Group 8; Including Residue Reduction . Information). Project Number: RCAMY006. Unpublished study prepared by Bayer Corp. 300 p. 46817121 Fischer, D. (2005) NNI-0001 24 WG - Magnitude of the Residue in/on Head and Stem Brassica (Crop Subgroup 5A; Including Residue Reduction Information). Project Number: RCAMY001. Unpublished study prepared by Bayer Corp., Bayer CropScience and South Texas Ag Research, Inc. 301 p. 46817122 Fishcher, D. (2005) NNI-0001 24 WG - Magnitude of the Residue in/on Leafy Brassica Greens (Crop Subgroup 5B; Including Residue Reduction Information). Project Number: RCAMY001/1, 00816/M002. Unpublished study prepared by Bayer Corp., Bayer CropScience and South Texas Agricultural Research. 274 p. 46817123 Dacus, S.; Harbin, A. (2006) NNI-0001 24 WG - Magnitude of the Residue in/on Leafy Vegetables - (Crop Group 4; Including Residue Reduction Information). Project Number: RCAMY008, 00816/M002. Unpublished study prepared by Bayer Corp., Syntech Research and GLP ------- Research & Consulting. 449 p. 46817124 Zimmer, D.; Dacus, S. (2006) NNI-0001 24 WG - Magnitude of the Residue in/on Cucurbit Vegetables - Crop Group 9 (Including Reduction Information). Project Number: RCAMY015, 00816/M002. Unpublished study prepared by Bayer Corp., GLP Research & Consulting and South Texas Ag Research, Inc. 336 p. 46817125 Lenz, C. (2005) NNI-0001 480 SC - Magnitude of the Residue in/on Field Cora Grain, Com Aspirated Grain Fractions, and Com Processed Commodities. Project Number: RCAMY005, 00816/M002, AM050207B/NNI. Unpublished study prepared by Bayer Corp. and Texas A & M Research Center. 209 p. 860.1520 Processed food/feed MRID Citation Reference 46817125 Lenz, C. (2005) NNI-0001 480 SC - Magnitude of the Residue in/on Field Com Grain, Corn Aspirated Grain Fractions, and Corn Processed Commodities. Project Number: RCAMY005, 00816/M002, AM050207B/NNI. Unpublished study prepared by Bayer Corp. and Texas A & M Research Center. 209 p. 46817126 Murphy, J. (2006) NNI-0001 480 SC - Magnitude of the Residue on Cotton Processed Commodities. Project Number: RCAMY003, AM051128AD/NNI/A1, AM051128AD/NN1. Unpublished study prepared by Bayer Corp. and GLP Technologies. 137 p. 46817127 Lenz, C. (2005) NNI-0001 480 SC - Magnitude of the Residue on Grape Processed Commodities. Project Number: RCAMY017, AM050404ABC/NNI/A1, AM050404ABC/NNI. Unpublished study prepared by Bayer Corp., National Food Laboratory, Inc. and Excel Research Services, Inc. 150 p. 46817128 Lenz, C. (2006) NNI-0001 480 SC - Request for Waiver of the Study of the Magnitude of the Residue in/on Soybean Processed Commodities from a Rotational Crop of Soybeans. Project Number: RAAMY014, 00816/M002. Unpublished study prepared by Bayer Corp. and Texas A & M Food Protein Research &. 76 p. 46817129 Lenz, C. (2006) NNI-0001 480 SC - Request for Waiver of the Study of the Magnitude of the Residue in/on Wheat Processed Commodites from a Rotation Crop of Wheat. Project Number: RAAMY007, 00816/M002. Unpublished study prepared by Bayer Corp. 68 p. 46817130 Helfrich, K.; Mackie, S. (2005) NNI-0001 480 SC: Magnitude of the Residue on Apple Processed Commodities. Project Number: RCAMY010, 00816/M002, AM041216C/NNI/A1. Unpublished study ------- prepared by Bayer Corp., National Food Laboratory, Inc. and Quails Agricultural Laboratories, I. 195 p. 46817131 Helfrich, K.; Mackie, S. (2006) NNI-0001 480 SC: Magnitude of the Residue on Plum Processed Commodities. Project Number: RCAMY012, AM050104A/NNI/A1, AM050104A/NNI. Unpublished study prepared by Bayer Corp. and National Food Laboratory, Inc. 126 P- 46817132 Fischer, D. (2005) NNI-0001 24 WG - Magnitude of the Residue in/on Tomatoes and Tomato Processed Commodities. Project Number: RCAMY007, 00816/M002, MG6880. Unpublished study prepared by Bayer Corp. and National Food Laboratory, Inc. 233 p. 860.1850 Confined accumulation in rotational crops MRID Citation Reference 46817133 Reiner, H. (2004) Metabolism of [Aniline Ring-UL-(Carbon 14)] NNI- 0001 in Confined Rotational Crops. Project Number: MEF/009/03, M/1031192/7. Unpublished study prepared by Bayer Ag, Institute of Product Info. & Residue Anal. 212 p. 46817134 Reiner, H. (2004) Metabolism of [Phthalic Acid Ring-UL-(Carbon 14)] NNI-0001 in Confined Rotational Crops. Project Number: MEF/008/03, M/1301191/6. Unpublished study prepared by Bayer Ag, Institute of Product Info. & Residue Anal. 214 p. 860.1900 Field accumulation in rotational crops MRID Citation Reference 46817135 Fischer, D. (2006) NNI-0001 480 SC - Magnitude of the Residue in Barley (Rotational Crop Tolerance). Project Number: RAAMY009, AMOS 1115 A/NNI, AMOS 1115/NNI/A1. Unpublished study prepared by Bayer Corp. 192 p. 46817136 Fischer, D. (2006) NNI-0001 480 SC - Magnitude of the Residue in Mustard Greens When Planted as a Roational Crop Following Treatment of Cotton, Squash, or Sweet Corn With NNI-0001 480 SC at the Maximum Proposed Label Specifications (Limited Rotational Crop). Project Number: AS19MG01, RCAM1000, AM/002/P05/01. Unpublished study prepared by Bayer Corp. 186 p. 46817137 Xu, T.; Fischer, D. (2006) NNI-0001 480 SC - Magnitude of the Residue in Sorghum (Rotational Crop Tolerance). Project Number: RAAMY012, 00816/M002, AM050315BC/NNI. Unpublished study prepared by Bayer Corp., South Texas Ag. Research and Shoffner Farm Research. 194 p. ------- 46817138 Duah, F.; Harbin, A. (2006) NNI-0001 480 SC - Magnitude of the Residue in Soybeans (Rotational Crop Tolerance). Project Number: RAAMY013, 00816/M002, AM050309AB/NNI. Unpublished study prepared by Bayer Corp., Agvise Inc. and Agresources, Inc. 275 p. 46817139 Fischer, D. (2006) NNI-0001 280 SC - Magnitude of the Residue in Turnips When Planted as a Rotational Crop Following Treatment of Cotton, Squash, or Sweet Corn with NNI-0001 480 SC at the Maximum Proposed Label Specifications (Limited Rotational Crop). Project Number: AS19TU01, RCAM 1005, AM/002/P05/01. Unpublished study prepared by Bayer Corp. and South Texas Ag. Research. 211 p. 46817140 Fischer, D. (2006) NNI-0001 480 SC - Magnitude of the Residue in Wheat (Rotational Crop Tolerance). Project Number: RAAMY008, 00816/M002, AM050412ABC/NNI/A1. Unpublished study prepared by Bayer Corp. and Quails Agricultural Laboratories, I. 251 p. 46817141 Fischer, D. (2006) NNI-0001 480 SC - Magnitude of the Residue in Wheat When Planted as a Rotational Crop Following Treatment of Cotton, Squash, Mustard Greens, or Sweet Corn with NNI-0001 480 SC at the Maximum Proposed Label Specifications (Limited Rotational Crop). Project Number: RCAM1010, AS19WH01, AM/002/P05/01. Unpublished study prepared by Bayer Corp. 281 p. 870.1000 Acute toxicity testing—background MRID Citation Reference 46817236 Langewische, F. (2006) Perinatal Ocular Toxicity Study in CD-1 Mice Following Exposure Via Diet: NNI-0001. Project Number: AT02781, TXAMX036, T2073354. Unpublished study prepared by Bayer Ag Inst. of Toxicology. 191 p. 870.1100 Acute oral toxicity MRID Citation Reference 46817142 Horiuchi, K. (2003) Acute Oral Toxicity Study of NNI-0001 in Rats: Final Report. Project Number: GA/01, 02/0004, LSRC/T02/026A. Unpublished study prepared by Nihon Nohyaku Co., Ltd., Agvise Inc. and Agro-Tech, Inc. 22 p. 46817143 Schungel, M. (2004) Acute Toxicity in the Rat After Oral Administration: NNI-0001 480 SC. Project Number: AT01182, TXAM0190, T/8074098. Unpublished study prepared by Bayer CropScience LP. 25 p. 46817144 Eiben, R. (2004) Acute Toxicity in the Rat After Oral Administration: NNI-0001 24 WG. Project Number: AT01622, T/3074651, ID64005/04. ------- 870.1200 MRID Unpublished study prepared by Bayer Ag Pflanzenschutz-Entwicklung. 23 p. Acute dermal toxicity Citation Reference 46817145 46817146 46817147 870.1300 MRID Horiuchi, K. (2003) Acute Dermal Toxicity Study of NNI-0001 in Rats: Final Report. Project Number: GA/01, 02/0005, LSRC/T02/027A. Unpublished study prepared by Nihon Nohyaku Co., Ltd. 22 p. Schungel, M. (2004) NNI-0001 480 SC: Acute Toxicity in the Rat After Dermal Application. Project Number: T/9074099, TXAM0195, AT01183. Unpublished study prepared by Bayer CropScience LP. 26 p. Eiben, R. (2004) Acute Toxicity in the Rat After Dermal Application: NNI-0001 24 WG. Project Number: AT01623, T/4074652, TXAMX025. Unpublished study prepared by Bayer Ag Pflanzenschutz-Entwicklung. 26 p. Acute inhalation toxicity Citation Reference 46817148 Wesson, C. (2004) NNI-0001: Acute Inhalation Toxicity (Nose Only) Study in the Rat. Project Number: 289/119. Unpublished study prepared by Safepharm Laboratories Ltd. 46 p. 46817149 Pauluhn, J. (2004) NNI-0001 480 SC: Acute Inhalation Toxicity in Rats. Project Number: TXAM0185, T5073302, AT01263. Unpublished study prepared by Bayer Ag, Institute of Product Info. & Residue Anal. 67 p. 46817150 Christenson, W. (2006) Justification for Waiving an Acute Inhalation Toxicity Study With the 24WG Formulation of NNI-0001 Technical. Project Number: 201490. Unpublished study prepared by Bayer CropScience LP. 5 p. 870.2400 Acute eye irritation MRID Citation Reference 46817201 Horiuchi, K. (2004) Eye Irritation Study of NNI-0001 in Rabbits: Final Report. Project Number: GA/02, 02/0031, LSRC/T02/065A. Unpublished study prepared by Nihon Nohyaku Co., Ltd. 26 p. 46817202 Schungel, M. (2004) NNI-0001 480 SC: Acute Eye Irritation on Rabbits. Project Number: AT01509, T0074379, TXAM0175. Unpublished study prepared by Bayer Ag Inst. of Toxicology. 20 p. 46817203 Schungel, M. (2005) NNI-0001 24 WG: Acute Eye Irritation on Rabbits. ------- Project Number: AT01758, T/9074396, TXAMX028. Unpublished study prepared by Bayer Ag Inst. of Toxicology. 20 p. 870.2500 Acute dermal irritation MRID Citation Reference 46817204 Horiuchi, K. (2004) Skin Irritation Study of NNI-0001 in Rabbits: Final Report. Project Number: GA/02, 02/0030, LSRC/T02/064A. Unpublished study prepared by Nihon Nohyaku Co., Ltd. 21 p. 46817205 Schungel, M. (2004) NNI-0001 480 SC: Acute Skin Irritation/Corrosion on Rabbits: Final Report. Project Number: T/9074378, AT01500. Unpublished study prepared by Bayer Ag Inst. of Toxicology. 19 p. 46817206 Schungel, M. (2005) NNI-0001 24 WG: Acute Skin Irritation/Corrosion on Rabbits. Project Number: AT01752, TXAMX029, T/8074395. Unpublished study prepared by Bayer Ag Inst. of Toxicology. 20 p. 870.2600 Skin sensitization MRID Citation Reference 46817207 Horiuchi, K. (2004) Skin Sensitization Study of NNI-0001 in Guinea Pigs (Maximization Test): Final Report. Project Number: GA/03, 02/0003, LSRC/T03/077A. Unpublished study prepared by Nihon Nohyaku Co., Ltd. 47 p. 46817208 Vohr, H. (2004) NNI-0001 480 SC: Study for the Skin Sensitization Effect in Guinea Pigs (Buehler Patch Test). Project Number: AT01492, TXAM0202. Unpublished study prepared by Bayer Ag Inst. of Toxicology. 29 p. 46817209 Vohr, H. (2004) NNI-0001 24 WG: Study for the Skin Sensitization Effect in Guinea Pigs (Buehler Patch Test). Project Number: AT01645, TXAMX031, T/7074150. Unpublished study prepared by Bayer Ag Inst. of Toxicology. 26 p. 870.3100 90-Day oral toxicity in rodents MRID Citation Reference 46817210 Enomoto, A. (2003) NNI-0001: Repeated Dose 90-Day Oral Toxicity Study in Rats: Final Report. Project Number: IET/01/0013. Unpublished study prepared by Institute of Environmental Toxicology. 780 p. 46817211 Takeuchi, Y. (2002) NNI-0001: Repeated Dose 90-Day Oral Toxicity Study in Mice: Final Report. Project Number: IET/01/0049. Unpublished study prepared by Nihon Nohyaku Co., Ltd. 258 p. ------- 870.3150 90-day oral toxicity in nonrodents MRID Citation Reference 46817212 Kuwahara, M. (2003) NNI-0001: Repeated Dose 90-Day Oral Toxicity Study in Dogs: Final Report. Project Number: IET/01/0062. Unpublished study prepared by Institute of Environmental Toxicology. 300 p. 870.3200 21/28-day dermal toxicity MRID Citation Reference 46817213 Krotlinger, F. (2004) 30-Day Toxicity Study in the Rat by Dermal Administration: NNI-0001. Project Number: AT01704, TXAM0026, T/6073709. Unpublished study prepared by Bayer Ag Inst. of Toxicology. 275 p. 870.3700 Prenatal developmental toxicity study MRID Citation Reference 46817214 Takahashi, K. (2002) NNI-0001: Teratogenicity Study in Rabbits: Final Report. Project Number: IET/01/0128. Unpublished study prepared by Institute of Environmental Toxicology. 126 p. 46817215 Aoyama, H. (2003) NNI-0001: Teratogenicity Study in Rats: Final Report. Project Number: IET/02/0036. Unpublished study prepared by Institute of Environmental Toxicology. 117 p. 46817240 Takahashi, K. (2001) NNI-0001: Preliminary Teratogenicity Study in Rabbits: Final Report. Project Number: IET/01/0030. Unpublished study prepared by Institute of Environmental Toxicology. 96 p. 46817241 Aoyama, H. (2002) NNI-0001: Preliminary Teratogenicity Study in Rats: Final Report. Project Number: IET/01/0113. Unpublished study prepared by Institute of Environmental Toxicology. 93 p. 870.3800 Reproduction and fertility effects MRID Citation Reference 46817216 Hojo, H. (2004) NNI-0001: Reproductive Toxicity Study in Rats: Final Report. Project Number: IET/01/0127. Unpublished study prepared by Institute of Environmental Toxicology. 617 p. 870.4100 Chronic toxicity MRID Citation Reference ------- 46817217 Enomoto, A. (2004) NNI-0001: Repeated Dose 1 -Year Oral Toxicity Study in Rats: Final Report. Project Number: T/8016, IET/01/0079. Unpublished study prepared by Institute of Environmental Toxicology. 986 p. 46817218 Kuwahara, M. (2004) NNI-0001: 52-Week Chronic Toxicity Study in Dogs: Final Report. Project Number: IET/02/0035. Unpublished study prepared by Institute of Environmental Toxicology. 415 p. 870.4200 Carcinogenicity MRID Citation Reference 46817219 Enomoto, A. (2004) NNI-0001: Carcinogenicity Study in Rats: Final Report. Project Number: IET/02/0035, T/8059. Unpublished study prepared by Institute of Environmental Toxicology. 691 p. 46817220 Takeuchi, Y. (2004) NNI-0001: Carcinogenicity Study in Mice: Final Report. Project Number: IET/01/0126, T/8019. Unpublished study prepared by Institute of Environmental Toxicology. 648 p. 870.5100 Bacterial reverse mutation test MRID Citation Reference 46817221 Inagaki, K. (2003) Bacterial Reverse Mutation Test of NNI-0001: Final Report (Amendment 1). Project Number: GA/08, 02/0017, LSRC/T02/018A. Unpublished study prepared by Nihon Nohyaku Co., Ltd. 39 p. 46817222 Herbold, B. (2004) NNI-0001 480 SC: Salmonella/Microsome Test Plate Incorporation and Preincubation Method. Project Number: AT01237, T/3073247, TXAMM004. Unpublished study prepared by Bayer Ag Inst. of Toxicology. 53 p. 870.5375 In vitro mammalian chromosome aberration test MRID Citation Reference 46817223 Miyahana, K. (2004) In Vitro Chromosome Aberration Test of NNI- 0001 in Cultured Chinese Hamster Cells: Final Report. Project Number: GA/08, 02/0116. Unpublished study prepared by Nihon Nohyaku Co., Ltd. 32 p. 46817224 Herbold, B. (2003) NNI-0001: V79/HPRT-Test In Vitro for the Detection of Induced Forward Mutations. Project Number: T/2071518, AT00460. Unpublished study prepared by Bayer Ag hist, of Toxicology. ------- 36 p. 870.5395 Mammalian erythrocyte micronucleus test MRID Citation Reference 46817225 Miyahana, K. (2003) Micronucleus Test of NNI-0001 in Mice: Final Report. Project Number: GA/08, 02/0020, LSRC/T02/089A. Unpublished study prepared by Nihon Nohyaku Co., Ltd. 33 p. 46817226 Herbold, B. (2005) NNI-001: Micronucleus-Test on the Male Mouse. Project Number: TXAMX034, AT01775, T/0073947. Unpublished study prepared by Bayer Ag Inst. of Toxicology. 49 p. 870.6200 Neurotoxicity screening battery MRID Citation Reference 46817227 Gilmore, R.; Lake, S. (2003) An Acute Oral Neurotoxicity Screening Study with Technical Grade NNI-0001 in Fischer 344 Rats. Project Number: 02/N12/LC, 200489. Unpublished study prepared by Bayer Corp. 445 p. 870.6300 Developmental neurotoxicity study MRID Citation Reference 46817228 Sheets, L.; Gilmore, R.; Hoss, H. (2006) A Developmental Neurotoxicity Screening Study with Technical Grade NNI-0001 in Wistar Rats. Project Number: 04/D72/VK, 201448. Unpublished study prepared by Bayer Corp. 1136 p. 870.7485 Metabolism and pharmacokinetics MRID Citation Reference 46817229 46817230 46817231 Motoba, K. (2005) Absorption, Distribution, Metabolism and Excretion of Radiolabeled NNI-0001 Following a Single Oral Administration to Male and Female Rats: Final Report (Amended I). Project Number: GB/01, 03/0022, LSRC/M04/115A. Unpublished study prepared by Nihon Nohyaku Co., Ltd. 142 p. Motoba, K. (2005) Absorption, Distribution, Metabolism and Excretion of [phthalic ring (U)-(Carbon 14)] NNI-0001 Following 14 Repetitive Oral Administration to Male and Female Rats: Final Report (Amended I). Project Number: GB/01, 03/0222, LSRC/M04/114A. Unpublished study prepared by Nihon Nohyaku Co., Ltd. 81 p. Motoba, K. (2004) Biliary Excretion Study of [phthalic Ring-(U)- ------- (Carbon 14)] NNI-0001 Following a Single Oral Administration to Male and Female Rats: Final Report. Project Number: GB/01, 01/0151, LSRC/M04/107A. Unpublished study prepared by Nihon Nohyaku Co., Ltd. 167 p. 46817232 Motoba, K. (2004) In Vitro Metabolism Study of NNI-0001: Final Report. Project Number: GB/05, 03/0181, LSRC/M04/184A. Unpublished study prepared by Nihon Nohyaku Co., Ltd. 57 p. 46817233 Motoba, K. (2005) Toxicokinetics of NNI-0001: Concentration in Selected Organs, Tissues and Plasma Following Repetitive Daily Administration to Rats and Mice: Final Report. Project Number: GA/25, 05/0230, LSRC/M05/248A. Unpublished study prepared by Nihon Nohyaku Co., Ltd. 62 p. 870.7600 Dermal penetration MRID Citation Reference 46817234 Bomann, W. (2005) A Study to Determine the Dermal Absorption of NNI-0001 SC 480 when Administered Dermally to Male Rhesus Monkeys: Final Report. Project Number: VCBZ/0111/03/742, 201134, 03C/B29/TL. Unpublished study prepared by Charles River Laboratories. 131 p. 870.7800 Immunotoxicity MRID Citation Reference 46817243 Krotlinger, F.; Vohr, H. (2005) Project: NNI-0001: Immunotoxicity Study in Rats - Plaque Assay (4-Weeks Administration by Diet). Project Number: AT02098, TXAMM002, T1073902. Unpublished study prepared by Bayer Ag Inst. of Toxicology. 149 p. 875.1300 Inhalation exposure—outdoor MRID Citation Reference 46817247 Standart, V. (2006) Occupational Exposure & Safety Assessment for Mixers/Loaders, Applicators and Reentry Workers During Use of. Project Number: 201475. Unpublished study prepared by Bayer CropScience LP. 27 p. 875.2100 Foliar dislodgeable residue dissipation MRID Citation Reference 46817246 Hoag, R.; Belcher, T. (2004) Renounce 20 WP - Dislodgeable Foliar ------- 875.2400 MRID Residue and Worker Re-entry Following Application to Sweet Corn: Final Report. Project Number: CY251601, CY264601, RCBDY032. Unpublished study prepared by Bayer Corp. and Morse Laboratories, Inc. 667 p. Dermal exposure Citation Reference 46817246 Hoag, R.; Belcher, T. (2004) Renounce 20 WP - Dislodgeable Foliar Residue and Worker Re-entry Following Application to Sweet Corn: Final Report. Project Number: CY251601, CY264601, RCBDY032. Unpublished study prepared by Bayer Corp. and Morse Laboratories, Inc. 667 p. 875.2500 Inhalation exposure MRID Citation Reference 46817246 Hoag, R.; Belcher, T. (2004) Renounce 20 WP - Dislodgeable Foliar Residue and Worker Re-entry Following Application to Sweet Corn: Final Report. Project Number: CY251601, CY264601, RCBDY032. Unpublished study prepared by Bayer Corp. and Morse Laboratories, Inc. 667 p. 850.7100 Data reporting for environmental chemistry methods MRID Citation Reference 46816925 Seymour, R.; Beck, D. (2005) Independent Laboratory Validation of "Method 00849 for the Determination of Residues of NNI-0001, NNI- 0001-des-iodo, NNI-0001-3-OH, NNI-0001-3-OH- hydroxyperfluoroalkyl and NNI-0001-Benzoic Acid in Soil and Sediment by HPLC-MS/MS". Project Number: RAAMX006, 00849. Unpublished study prepared by Bayer Corp. 76 p. 46816928 Netzband, D.; Yin, J. (2006) Independent Laboratory Validation of "Method 00838 (MR-134/03) for the Determination of NNI-0001 and NNI-0001-des-iodo in Drinking and Surface Water by HPLC-MS/MS". Project Number: RAAMX098, MR/134/03, 000838. Unpublished study prepared by Bayer Corp. 78 p. 46816929 Netzband, D.; Yin, J. (2006) Determination of NNI-0001 and NNI-0001- des-iodo in Drinking and Surface Water by LC/MS/MS. Project Number: AM/003/W06/01. Unpublished study prepared by Bayer Corp. 27 p. ------- 850.1790 Chironomid Sediment Toxicity Test MRID Citation Reference 46817013 Dorgerloh, M. (2005) Acute Toxicity of NNI-0001 SC 480 to Larvae of Chironomus riparius in a Static Laboratory Test System. Project Number: EBAMX024, E/322/2846/6. Unpublished study prepared by Bayer Ag, Institute of Product Info. & Residue Anal. 53 p. 46817014 Dorgerloh, M. (2005) Acute Toxicity of NNI-0001 WG 24 to Larvae of Chironomus riparius in a Static Laboratory Test System. Project Number: EBAMX023, E/322/2844/5. Unpublished study prepared by Bayer Ag, Institute of Product Info. & Residue Anal. 53 p. 46817022 Dorgerloh, M. (2003) Chironomus riparius 28-Day Chronic Toxicity Test with the NNI-0001 (Tech.) in a Water-Sediment System Using Spiked Water. Project Number: DOM/23005, E/416/2340/0, MR/188/02. Unpublished study prepared by Bayer Ag, Institute of Product Info. & Residue Anal. 102 p. 46817023 Dorgerloh, M. (2004) Chironomus riparius 28-Day Chronic Toxicity Test with NNI-0001-des-iodo in a Water-Sediment System Using Spiked Water. Project Number: DOM/23069, E/416/2518/7, 00838. Unpublished study prepared by Bayer Ag, Institute of Product Info. & Residue Anal. 130 p. 850.6200 Earthworm subchronic toxicity test MRID Citation Reference 46817028 Kunze, C. (2002) NNI-0001 (Tech.): Acute Toxicity to Earthworms (Eisenia fetida). Project Number: E/310/2293/0, LKC/RG/406/02, RG/11/02. Unpublished study prepared by Bayer Ag, Institute of Product Info. & Residue Anal. 14 p. 46817029 Lechelt-Kunze, C. (2004) NNI-0001 SC 480: Acute Toxicity to Earthworms (Eisenia fetida) Tested in Artificial Soil. Project Number: E/310/2772/2, RG/18/04, LKC/RG/A/35/04. Unpublished study prepared by Bayer Ag, Institute of Product Info. & Residue Anal. 22 p. 46817030 Lechelt-Kunze, C. (2004) NNI-0001 -des-iodo: Acute Toxicity to Earthworms (Eisenia fetida) Tested in Artificial Soil with 5% Peat: Amended Report. Project Number: E/310/2564/1, LKC/RG/A/21/04. Unpublished study prepared by Bayer Ag, Institute of Product Info. & Residue Anal. 23 p. 46817031 Luhrs, U. (2002) NNI-0001 SC480: Effects on Reproduction and Growth of Earthworms Eisenia fetida in Artificial Soil: Final Report. Project Number: 14421022. Unpublished study prepared by Institut fuer ------- Biologische Analytik und Consulting IBACON. 33 p. 46817032 Lechelt-Kunze, C. (2005) NNI-0001 WG 24: Effects on Survival, Growth and Reproduction on the Earthworm Eisenia fetida Tested in Artificial Soil. Project Number: E/312/2847/7, LKC/RG/R/11/05, RG/19/05. Unpublished study prepared by Bayer Ag, Institute of Product Info. & Residue Anal. 39 p. 850.7100 Data reporting for environmental chemistry methods MRID Citation Reference 46817042 Barfknecht, R. (2006) Dissipation of the Active Substance NNI-0001 from Exposed Grass After a Spray Application with NNI-0001 SC 480. Project Number: E/308/2949/5, BAR/FS/027. Unpublished study prepared by Bayer Ag, Institute of Product Info. & Residue Anal. 37 p. Non-Guideline Study MRID Citation Reference 46816900 Bayer CropScience LP and Nichino America, Inc. (2006) Submission of Product Chemistry, Residue, Fate, Environmental Fate and Toxicity Data in Support of the Application for Registrations of NNI-0001 Techncial, NNI-0001 480 SC and NNI-0001 24 WG, and the Petition for Tolerance of Flubendiamide on Corn (Field Corn, Pop Corn, Sweet Corn, and Corn Grown for Seed), Cotton, Tobacco, Tree Fruit, Nut, and Vine Crops and Vegetable Crops. Transmittal of 49 of 201 Studies. 46816918 Hellpointner, E. (2003) Calculation of the Chemical Lifetime of NNI- 0001 in the Troposphere. Project Number: M1451332/9, MEF/362/03. Unpublished study prepared by Bayer Ag, Institute of Product Info. & Residue Anal. 13 p. 46816919 Hellpointner, E. (2004) Determination of the Quantum Yield and Assessment of the Environmental Half-life of the Direct Photodegradation in Water: NNI-0001. Project Number: M1431261/8, MEF/099/03, M/143/1261/8. Unpublished study prepared by Bayer Ag, Institute of Product Info. & Residue Anal. 35 p. 46816920 Hellpointner, E. (2003) Determination of the Quantum Yield and Assessment of the Environmental Half-life of the Direct Photodegradation in Water: NNI-0001-Des-Iodo. Project Number: M1431300/2, MEF/214/03, M/143/1300/2. Unpublished study prepared by Bayer Ag, Institute of Product Info. & Residue Anal. 32 p. 46816921 Hellpointner, E. (2004) Determination of the Quantum Yield and Assessment of the Environmental Half-Life of the Direct Photo- degradation in Water: NNI-0001-3-OH-hydroxyperfluoroalkyl (A 10). ------- Project Number: M1431306/8, MEF/275/03, M/143/1306/8. Unpublished study prepared by Bayer Ag, Institute of Product Info. & Residue Anal. 43 p. 46816922 Babczinski, P. (2004) Outdoor Soil Degradation of [(Carbon 14)]NNI- 001. Project Number: MEF/04/418, M1251280/9, M/125/1280/9. Unpublished study prepared by Bayer Ag, Institute of Product Info. & Residue Anal. 126 p. 46816923 Brumhard, B. (2006) Determination of the Storage Stability of NNI- 0001, NNI-OOOl-des-iodo, NNI-0001-3-OH, NNI-0001-3-OH- Hydrxyperfluoroalkyl and NNI-OOOl-Benzoic Acid in Soil. Project Number: P641030027, MR/06/014. Unpublished study prepared by Bayer Ag, Institute of Product Info. & Residue Anal. 80 p. 46816924 Brumhard, B. (2004) Analytical Method 00849 for the Determination of Residues of NNI-0001, and its Metabolites NNI-OOOl-des-iodo, NNI- 0001-3-OH, NNI-OOOl-3-OH-Hydroxyperfluroalkyl and NNI-OOOl- Benzoic Acid in Soil and Sediment by HPLC-MS/MS. Project Number: P601030020, MR/202/03, 00849. Unpublished study prepared by Bayer Ag, Institute of Product Info. & Residue Anal. 94 p. 46816926 Seymour, R.; Beck, D. (2004) NNI-0001: Analytical Method AM-001- S04-01 for Determination of Residues of NNI-0001, NNI-OOOl-des-iodo, NNI-0001-3-OH, NNI-0001 -3-OH-Hydroxyperfluoroalkyl and NNI- OOOl-Benzoic Acid in Soil and Sediment by HPLC-MS/MS. Project Number: AM/001/S04/01. Unpublished study prepared by Bayer Corp. 38 p. 46816927 Brumhard, B. (2004) Analytical Method 00838 (MR-134/03) for the Determination of NNI-OOOl-des-iodo in Drinking and Surface Water by HPLC-MS/MS. Project Number: P684/037058, MR/134/03, 00838. Unpublished study prepared by Bayer Ag, Institute of Product Info. & Residue Anal. 28 p. 46817000 Bayer Cropscience LP and Nichino America, Inc. (2006) Submission of Fate, Environmental Fate and Toxicity Data in Support of the Application for Registration of NNI-0001 Technical, NNI-0001 480 SC, NNI-0001 24 WG and the Petition for Tolerance of Flubendiamide for Use in/on Corn, Cotton, Tobacco, Tree Fruit, Vegetable Crops, Nut and Vine Crops. Transmittal of 50 Studies. 46817016 Moll, M. (2005) Effects of NNI-0001 SC 480 on the Ladybird Beetle Coccinella septempunctata, Extended Laboratory Study -Aged Residue Test- :Final Report. Project Number: 24321013. Unpublished study prepared by Institut fuer Biologische Analytik und Consulting IBACON. 46 p. 46817017 Maus, C. (2002) Evaluation of the Effects of NNI-0001 SC 480 on the Life Cycle of Ladybird Beetles (Coccinella septempunctata) under ------- Extended Laboratory Conditions. Project Number: E/398/2289/1, MAUS/CS004. Unpublished study prepared by Bayer Ag, Institute of Product Info. & Residue Anal. 38 p. 46817018 Waltersdorfer, A. (2004) Toxicity to the Green Lacewing Chrysoperla camea Steph. (Neuroptera, Chrysopidae) Using an Extended Laboratory Test: NNI-0001 SC 480 Water Miscible Suspension Concentrate. Project Number: CW03/030. Unpublished study prepared by Bayer Cropscience Gmbh. 26 p. 46817019 Waltersdorfer, A. (2005) Toxicity to the Predatory Mite Typhlodromus pyri Scheuten (Acari, Phytoseiidae) in the Laboratory: NNI-0001 24 WG Water Dispersible Granules. Project Number: CW05/025. Unpublished study prepared by Bayer Cropscience Gmbh. 34 p. 46817020 Waltersdorfer, A. (2005) Toxicity to the Parasitoid Wasp Aphidius rhopalosiphi (DeStephani-Perez) (Hymenoptera: Braconidae) in the Laboratory: NNI-0001 24 WG Water Dispersible Granules. Project Number: CW05/021. Unpublished study prepared by Bayer Cropscience Gmbh. 25 p. 46817021 Fussell, S. (2002) A Rate-Response Laboratory Test to Determine the Effects of NNI-0001 SC 480 on the Parasitic Wasp, Aphidius rhopalosiphi. Project Number: BAY/02/5. Unpublished study prepared by Mambo-Tox Ltd. 26 p. 46817025 Anderson, J. (2002) Influence of NNI-0001 SC 480 on Glucose Stimulated Respiration in Soils. Project Number: AJO/233002, 2749, E/3 3 0/2277/4. Unpublished study prepared by Bayer Ag, Institute of Product Info. & Residue Anal. 21 p. 46817026 Anderson, J. (2002) Influence of NNI-0001 SC 480 on the Microbial Mineralization of Nitrogen in Soils. Project Number: E/337/2278/2, AJO/233102, 2750. Unpublished study prepared by Bayer Ag, Institute of Product Info. & Residue Anal. 17 p. 46817100 Bayer CropScience LP and Nichino America (2006) Submission of Residue and Toxicity Data in Support of the Application for Registrations of Flubendiamide, NNI-0001 480 SC and NNI-0001 24 WG and the Petition for Tolerance of Flubendiamide on Corn (Field Corn, Pop Corn, Sweet Corn, and Corn Grown for Seed), Cotton, Tobacco, Tree Fruit, Nut and Vine Crops and Vegetable Crops. Transmittal of 50 of 200 Studies. 46817200 Bayer CropScience LP and Nichino America, Inc. (2006) Submission of Toxicity, Fate, Environmental Fate, Residue, Exposure and RiskData in Support of the Application for Registration of NNI-0001 Technical, NNI-0001 480 SC, NNI-0001 24 WG and the Petition for Tolerance of Flubendiamide for Use on Com, Cotton, Tobacco, Tree Fruit, Nut and Vine Crops and Vegetable Crops. Transmittal of 52 of 202 Studies. ------- 4681723 5 Amanuma, T. (2005) Effect of NNI-0001 Administration on the Thyroid-Related Hormones and Liver Drug-Metabolizing Enzymes in Female F-344 Rats. Project Number: GA/11, 02/0162, LSRC/T05/041 A. Unpublished study prepared by Nihon Nohyaku Co., Ltd. 118 p. 46817237 Freyberger, A. (2003) NNI-0001: Studies on Interactions with lodothyronine Deidinase Type I in Vitro. Project Number: AT00471, T2071996. Unpublished study prepared by Bayer Ag Inst. of Toxicology. 20 p. 4681723 8 Takeuchi, Y. (2005) NNI-0001: One-Generation Reproductive Toxicity Study in Rats Histopathological Examination of the Eyes of Weanlings: Final Report. Project Number: IET/04/0075. Unpublished study prepared by Institute of Environmental Toxicology. 50 p. 46817239 Hojo, H. (2004) NNI-0001: One-Generation Reproductive Toxicity Study in Rats: Final Report. Project Number: IET/03/0013. Unpublished study prepared by Institute of Environmental Toxicology. 354 p. 46817242 Kuwahara, M. (2001) NNI-0001: Repeated Dose 28-Day Oral Toxicity Study in Dogs: Final Report. Project Number: IET/01/0019. Unpublished study prepared by Institute of Environmental Toxicology. 115 p. 46817248 Sabbagh, G. (2006) Aquatic Exposure Assessment for NNI-0001. Proj ect Number: MEAMY002. Unpublished study prepared by Bayer Corp. 67 P- 46817249 Sabbagh, G. (2006) Screening Level Drinking Water Exposure Assessment for the Use . Project Number: MEAMY001. Unpublished study prepared by Bayer CropScience LP. 52 p. 46817250 Lenz, C. (2006) Aggregate Dietary Exposure to NNI-0001 and Assessment of Potential Risk. Project Number: RGAMY004. Unpublished study prepared by Bayer CropScience LP. 71 p. 46817251 Hall, T.; Sabbagh, G.; Kelly, I. (2005) Environmental Fate and Ecological Risk Assessment for NNI-0001. Project Number: EBAMP027. Unpublished study prepared by Bayer CropScience LP. 94 P- 46817252 Buckelew, L.; Larochelle, D.; Christenson, R.; et al. (2006) NNI-0001 (Flubendamide): Human Health Risk Assessment for Use on Corn, Cotton, Tobacco, Tree Nut, Vine Crops and Vegetable Crops. Project Number: G201491, M/268723/01/1. Unpublished study prepared by Bayer CropScience LP. 117 p. 47263100 Nichino America, Inc. (2007) Submission of Residue Data in Support of the Application for Registration of NNI-0001 Technical. Transmittal of 2 Studies. ------- 47325300 Bayer CropScience (2008) Submission of Public Interest Data in Support of the Application for Registration of NNI-0001 Technical. Transmittal of 1 Study. 47325301 Nelson, J.; Speas, J.; Kelly, I.; et al. (2008) Public Interest Document Supporting the Registration of Flubendiamide (NNI-0001) to Control Commercially Important Lepidoptera Pests in Corn, Cotton, Tobacco, Leafy Vegetables and Vegetable, Tree Fruit, Nut and Vine Crops. Project Number: PID/BAY06JN23. Unpublished study prepared by ABG, Inc. 135 p. ------- |