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Epa Registration Division - Company Notice of Filing for Pesticide Petition EPA REGISTRATION DIVISION - COMPANY NOTICE OF FILING FOR PESTICIDE PETITION EPA Registration Division contact: Sidney Jackson, (703) 305-7610 Interregional Research Project Number 4 (IR-4) Pesticide Petition Number: PP# 4E8241 EPA has received a pesticide petition (PP# 4E8241) from Interregional Research Project Number 4 (IR-4), 500 College Road East, Princeton, NJ 08540 proposing, pursuant to section 408(d) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), to amend 40 CFR part 180 by establishing a tolerance for residues of novaluron in or on the raw agricultural commodities Avocado at 0.60 parts per million (ppm), Carrot at 0.05 ppm, Bean at 0.60 ppm, Vegetable, fruiting, group 8-10 at 1.0 ppm, Fruit, pome, group 11-10 at 2.0 ppm, Cherry subgroup 12-12A at 8.0 ppm, Peach subgroup 12- 12B at 1.9 ppm, and Plum subgroup 12-12C at 1.9 ppm. In addition, the petitioner proposes based upon the establishment of new tolerances above, removal of existing tolerances at 40 CFR 180.598 on Bean, succulent, snap at 0.60 ppm, Bean, dry, seed at 0.30 ppm, Cherry at 8.0 ppm, Fruit, pome, group 11 at 2.0 ppm, Fruit, stone, group 12, except cherry at 1.9 ppm, Vegetable, fruiting, group 8 at 1.0 ppm, cocona at 1.0 ppm, African eggplant at 1.0 ppm, pea eggplant at 1.0 ppm, scarlet eggplant at 1.0 ppm, goji berry at 1.0 ppm, garden huckleberry at 1.0 ppm, martynia at 1.0 ppm, naranjilla at 1.0 ppm, okra at 1.0 ppm, roselle at 1.0 ppm, sunberry at 1.0 ppm, bush tomato at 1.0 ppm, currant tomato at 1.0 ppm, and tree tomato at 1.0 ppm. EPA has determined that the petition contains data or information regarding the elements set forth in section 408 (d)(2) of the FDDCA; however, EPA has not fully evaluated the sufficiency of the submitted data at this time or whether the data support granting of the petition. Additional data may be needed before EPA rules on the petition. A. Residue Chemistry 1. Plant and Livestock metabolism. The qualitative nature of the residue of novaluron in plants is adequately understood based on acceptable plant metabolism studies reflecting its uses on apples, cabbage, cotton, and potatoes. These plant metabolism studies have demonstrated that novaluron does not metabolize and is non-systemic (does not translocate within the plant). The results observed in the plant and livestock metabolism studies show similar metabolic pathways. The residue of concern, which should be regulated, is the parent compound, novaluron only. 2. Analytical method. An adequate analytical enforcement method, gas chromatography/electron capture detector (GC/ECD) and a high performance liquid chromatography/ultraviolet method (HPLC/UV) for enforcing tolerances of novaluron residues in or on different matrices are available, as published in the Federal Register of January 27, 2010 (Volume 75, Number 17; FRL-8807-2). A method validation was conducted both prior to sample analysis and concurrently with sample analysis determining that the method recoveries were in the proper range. For avocado the LOD 2 for the method was calculated to be 0.00839 ppm and the LOQ was calculated to be 0.0252 ppm. For carrot the LOD for the method was calculated to be 0.0175 ppm and the LOQ was calculated to be 0.0524 ppm. For bean, the LOD for the method was calculated to be 0.013 ppm and the LOQ was calculated to be 0.039 ppm. For cucumber the LOD for the method was calculated to be 0.0091 ppm and the LOQ was calculated to be 0.027 ppm. The lowest level of method validation (LLMV) for these commodities was 0.05 ppm. 3. Magnitude of residues. Residue trials were conducted to support the tolerances requested above including the following: - Avocado: A total of 6 field trials were conducted in NAFTA Regions. - Carrot: A total of 8 field trials were conducted in NAFTA Regions. - Bean: A total of 6 field trials were conducted in NAFTA Regions. - Greenhouse grown cucumber: A total of 4 field trials were conducted in NAFTA Regions. B. Toxicological Profile 1. Acute toxicity. In an acute oral toxicity study in rats, novaluron had an LD50 >5,000 mg/kg. A dermal toxicity study in rats resulted in an LD50 greater than 2,000 mg/kg. The LC50 for acute inhalation in rats was great.er than 5.15 mg/I. In rabbits, novaluron is not a skin irritant, but it is a mild eye irritant. Novaluron is not a sensitizer in guinea pigs. 2. Genotoxicty. The mutagenic potential of novaluron was investigated in several in vivo and in vitro studies. Results in two Ames assays, an in vivo mouse micronucleus assay, an in vitro unscheduled DNA synthesis (UDS) assay, an in vitro cell mutation assay, and an in vitro human lymphocyte clastogenicity test were negative. Novaluron is therefore considered to have no potential to induce mutagenicity. 3. Reproductive and developmental toxicity. i. A two generation rat reproduction study was conducted with dose levels of 1,000, 4,000, and 12,000 ppm (74.2, 297.5, 894.9 mg/kg/day, and 84, 336.7, 1,009.8 mg/kg/day for males and females, respectively). Maternal and offspring toxicity was evidenced by increased absolute and relative spleen weights, whereas reproductive toxicity was observed only in males at 297.5 mg/kg/day (LOAEL) based on decreased epididymal sperm counts and increased age at preputial separation in the F1 generation. The no observed adverse effect level (NOAC) in males was 1,000 ppm (74.2 mg/kg/day) and in females it was 12,000 ppm (109.8 mg/kg/day). ii. Teratology studies were conducted in the rat and rabbit. No treatment related mortalities were observed in either study. No effect on survival, development or growth of fetuses was noted in either species in either study. No maternal or developmental toxicity was observed up to and including the limit dose of 1,000 mg/kg/day (NOAEL). These two studies demonstrate that novaluron was not teratogenic in either rats or rabbits. 4. Subchronic toxicity. Rats, mice and dogs all show the same toxicological response. Generally, novaluron induces small increases in methemoglobin; red cells are sequestered; and, compensatory hematopoiesis occurs. The severity of these changes is well within the physiological capacity of the animals and is judged not adverse. Rats treated topically with novaluron in a 28-day study at 0, 75, 400 and 1,000 mg/kg/day did not show signs of systemic toxicity. Small treatment-related increases in methemoglobin were seen in 3 both sexes at 1,000 mg/kg/day and in females at 400 mg/kg/day. The highest methemoglobin value seen in females was 1.28% compared with 0.86% in controls. Organ weights, macroscopic and microscopic examination of organs and tissues did not reveal any treatment-related changes. Two 13-week rat studies were conducted. In one study, doses were administered at 50, 100, 200, 400 ppm (3.52, 6.93, 13.83, 27.77 mg/kg/day and 4.38, 8.64, 17.54 and 34.39 mg/kg/day for males and females, respectively). The LOAELs from the combined results were 27.77 mg/kg/day in males based on increased occurrence of extramedullary hematopoiesis and hemosiderosis in spleen; and 8.64 mg/kg/day in females based on reduction in hemoglobin, hematocrit and RBC count; increased occurrence of extramedullary hematopoiesis and hemosiderosis in spleen and liver. The NOAEL was 4.38 mg/kg/day. A 13-week mouse study was conducted with dose levels of 30, 100, 1,000, 10,000 ppm (4.2, 12.8, 135.9, 1,391.9 and 4.7, 15.2, 135.6, 1,493.1 mg/kg/day, for males and females, respectively). The NOAEL was determined to be 100 ppm (12.8 and 15.2 mg/kg/day, male and females, respectively). The LOAEL was 1,000 ppm (135.9 and 135.6 mg/kg/day, males and females, respectively) based on increased body weight gain, low erythrocyte counts, and secondary splenic changes. There were no clinical treatment-related signs noted. Two 13-week dog studies were conducted. One study resulted in an NOAEL of 100 mg/kg/day and a LOAEL of 300 mg/kg/day based on low erythrocyte counts and secondary splenic and liver changes. No clinical treatment-related signs were noted. Another study was conducted using only one dose level of 10 mg/kg/day. There were no clinical or histopathological treatment-related signs and the NOAEL was determined to be 10 mg/kg/day. Acute and subchronic neurotoxicity screening batteries were performed with novaluron in rats. Novaluron is not considered neurotoxic, since effects observed in the acute neurotoxicity study were observed at the limit dose only and were not reproduced at similar, repeated doses in the subchronic neurotoxicity study (0, 17.5/20.5, 174/207, 1752/2000 mg/kg/day Male/Female). No signs of neurotoxicity or neuropathology were observed following, repeated dosing in the subchronic neurotoxicity study in rats or in any other subchronic or chronic toxicity study in rats, mice or dogs.] 5. Chronic toxicity. i. Chronic toxicity and oncogenicity was evaluated in the rat, mouse and dog. The rat chronic toxicity and oncogenicity was conducted with dose levels of 25, 700, 20,000ppm (1.1, 30.6, 884.2 and 1.4, 39.5, 1,113.5 mg/kg/day for males and females, respectively).
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