IR-4. Pesticide tolerance for pomegranate (post-harvest) at 5 ppm. FINAL RULE.
In the Federal Register of March 17, 2004, EPA issued a notice announcing the filing of a pesticide petition (PP 3E6803) by IR-4, 681 US Highway #1 South, North Brunswick, NJ 08902-3390. The petition requested that 40 CFR 180.516 be amended by establishing a tolerance for residues of the fungicide fludioxonil in or on pomegranate at 2.0 parts per million (ppm). This petition has subsequently been amended to propose pomegranate (post-harvest) at 5.0 ppm. That notice included a summary of the petition prepared by Syngenta Crop Protection, the registrant. There were no comments received in response to the notice of filing.

Pesticide Emergency Exemption.
• California - EPA authorized the use of fludioxonil on pomegranates to control gray mold; August 1, 2004 to December 15, 2004. Contact: (Andrew Ertman)

IR-4. Pesticide Tolerances. FINAL RULE. The nature of the toxic effects caused by fludioxonil as well as the no observed adverse effect level (NOAEL) and the lowest observed adverse effect level (LOAEL) from the toxicity studies reviewed are discussed in the Federal Register of December 29, 2000. In the Federal Register of March 17, 2004, EPA issued a notice announcing the filing of pesticide petitions (PP 3E6551, 3E6639, 3E6701, 3E6742, and 3E6803) by IR-4. That notice included a summary of the petitions prepared by Syngenta Crop Protection, Incorporated, the registrant. Subsequently, PP 3E6803 has been amended to delete citrus, dried pulp at 20 ppm, and pomegranate at 2.0 ppm. In addition, ``citrus, oil'' at 500 ppm, and ``yam'' at 8.0 ppm has been translated to ``grapefruit, oil'' at 500 ppm, and ``yam, true'' at 8.0, respectively.

March 17, 2004

OPP-2004-0046

IR-4; Syngenta. Five pesticide tolerance petitions.

1. PP 3E6551 proposes a tolerance for kiwifruit at 20 ppm.
2. PP 3E6639 proposes a tolerance for leafy greens subgroup 4A,
except spinach at 30 ppm.

[Leafy greens subgroup 4A, except spinach, includes: amaranth, grain; arugula; chervil; chrysanthemum, edible leaved; chrysanthemum, garland; corn salad; cress, garden; cress, upland; dandelion; dock; endive; lettuce; lettuce, head; lettuce, leaf; orach; parsley; purslane, garden; purslane, winter; radicchio; tampala]

3. PP 3E6701 proposes tolerances bean, dry and bean, succulent at
0.4 ppm.

4. PP 3E6742 proposes tolerances for fruit, pome, group 11 at 5.0 ppm, yam at 8.0 ppm, and melon subgroup 9A at 0.03 ppm.

[Fruit, pome, group 11 includes: apple; apple, dried pomace; apple, juice; apple, wet pomace; crabapple; fruit, pome; loquat; mayhaw; pear; pear, oriental; quince]

[Melon subgroup 9A includes: cantaloupe; citron melon; melon; melon, citron; muskmelon; watermelon]

5. PP 3E6803 proposes tolerances for citrus, crop group 10 at 10 ppm; citrus, dried pulp at 20 ppm, citrus, oil at 500 ppm, and
pomegranate at 2.0 ppm.

[Citrus, crop group 10 includes: calamondin; citron, citrus; citrus; citrus hybrids; citrus hybrids, dried pulp; citrus hybrids, juice; citrus hybrids, oil; citrus, dried pulp; citrus, juice; citrus, meal; citrus, molasses; citrus, oil; fruit; fruit, citrus; fruit, citrus, dried pulp; fruit, citrus, except mandarin; fruit, citrus, postharvest; grapefruit; grapefruit, dried pulp; grapefruit, juice; grapefruit, oil; kumquat; lemon; lemon, dried pulp; lemon, juice; lemon, oil; lime; lime, dried pulp; lime, juice; lime, oil; mandarin, satsuma; orange, sour; orange, sour, dried pulp; orange, sour, juice; orange, sour, oil; orange, sweet; orange, sweet, dried pulp; orange, sweet, juice; orange, sweet, oil; pummelo; tangelo; tangerine]

• An assessment of toxic effects caused by fludioxonil is discussed
in the August 2, 2002, Federal Register

IR-4; Syngenta. Pesticide Petition.
1. Pesticide Petition (PP) 2E6486 proposes tolerances as follows:
-- ¥ Brassica, head and stem subgroup 5a at 1.5 ppm
-- ¥ Brassica, leafy greens subgroup 5b at 9.0 ppm.
-- ¥ Turnip, greens at 9.0 ppm.
2. PP 2E6462 proposes a tolerance for carrot at 0.5 ppm.
3. PP 3E6526 proposes a tolerance for herb subgroup 19a at 33.0 ppm.
4. PP 2E6448 proposes a tolerance for the following:
-- ¥ Longan at 2.0 ppm.
-- ¥ Lychee at 2.0 ppm.
-- ¥ Pulasan at 2.0 ppm.
-- ¥ Rambutan at 2.0 ppm.
-- ¥ Spanish lime at 2.0 ppm.

2. Establish a seperate spice subgroup 19b tolerance at 0.02 ppm. As the result of this proposed amendment, the pending herb subgroup 19a tolerance at 33.0 ppm precludes the need for the existing herbs tolerance of 0.02 ppm. Moreover, the existing spices tolerance of 0.02 ppm is changed to spice subgroup 19b at 0.02 ppm which includes: allspice; anise, seed; anise, star; annatto, seed; caper, buds; caraway, black, seed; caraway, seed; cardamom, seed; cardamon; amomum, seed; cassia; celery, seed; cinnamon; clove; coriander, seed; culantro, seed; cumin; dill, seed; fennel, florence, seed; fennel, seed; fenugreek, seed; grains of paradise, seed; juniper berry; lovage, seed; mace; mustard, seed; nutmeg; pepper, black; pepper, white; poppy, seed; saffron, flower; vanilla.

NOTE: See EPA's Toxicological profile on Fludioxonil published in the Federal Register on December 29, 2000. The following adverse effects were noted:

• 90-Day oral toxicity in rats: decreased weight gain (both sexes), chronic nephropathy (Males) and centrilobular hepatocyte hypertrophy (Females).
• 90-Day oral toxicity in mice: decreased body weight gain (F), increased alkaline phosphatase (M), increased relative liver weight, increased incidence of nephropathy and centrilobular hypertrophy (both sexes).
• 90-Day oral toxicity in dogs: increased incidence of diarrhea (both sexes).
• Prenatal developmental in rodents: reduction in corrected weight gain, increase in the fetal incidence and litter incidence of dilated renal pelvis and dilated ureter.
• Prenatal developmental in non-rodents: decreased body weight gain and decreased food efficiency.
• Reproduction and fertility effects: decreased body weights, decreased weight gain, and decreased food consumption in both sexes, reduced pup weights during lactation.
• Chronic toxicity dogs; decreased weight gain (F) and decreased body weight, reduction in hematological parameters (platelets), increase in cholesterol and alkaline phosphatase, and increased relative liver weight (M).
• Combined Chronic Toxicity/ Carcinogenicity in rats: based on decreased mean body weight gain, slight anemia (F), and increased incidence and severity of liver lesions (degeneration) in both sexes. There was no evidence of carcinogenicity in male rats, but there was a statistically significant increase, both trend and pairwise, of combined hepatocellular tumors in female rats. Classified as ``Group D'' by OPP Cancer Peer Review Committee.
• Carcinogenicity mice: increased incidence of mice convulsing when handled (M) and increased absolute liver weight and grossly enlarged livers (F). Statistically significant trend for malignant lymphomas in females.
• In vivo Rat hepatocyte micronucleus assay: Positive for mutagenicity in hepatocytes exposed in vivo.

EPA approved the use of Fludioxonil for 2 Emergency Exemptions.

-- Oregon: Specific: EPA authorized the use of fludioxonil on peaches to control brown rot, gray mold, and Rhizopus rot; July 2, 2002 to September 30, 2002.
-- Oregon: EPA authorized the use of fludioxonil on cherries to control brown rot, gray mold, and Rhizopus rot; July 2, 2002 to August 15, 2002.

Emergency Exemptions for pesticide use.

• California Environmental Protection Agency, Department of Pesticide Regulation - Specific: EPA authorized the use of fludioxonil on pomegranates to control gray mold; August 1, 2002 to December 15, 2002.
• New Jersey Department of Environmental Protection. EPA authorized the use of fludioxonil on peaches and nectarines to control brown rot, gray mold, and Rhizopus rot; July 1, 2002 to September 30, 2002.
• Oregon Department of Agriculture - EPA authorized the use of cyprodinil and fludioxonil on caneberries to control gray mold; April 19, 2002 to September 15, 2002.
• South Carolina Clemson University - Specific: EPA authorized the use of fludioxonil on peaches, nectarines, and plums to control brown rot; May 1, 2002 to September 15, 2003.
• Washington Department of Agriculture - Specific: EPA authorized the use of cyprodinil and fludioxonil on caneberries to control gray mold; May 1, 2002 to September 15, 2002.

IR-4. Pesticide Tolerance. FINAL RULE. This regulation establishes tolerances for residues of fludioxonil in or on bushberry subgroup at 2.0 ppm, caneberry subgroup at 5.0 ppm, juneberry at 2.0 ppm, lingonberry at 2.0 ppm, pistachio at 0.10 ppm, salal at 2.0 ppm, stone fruit group at 2.0 ppm, and watercress at 7.0 ppm. The petition for the stone fruit group was amended to propose a tolerance for fludioxonil at 5.0 ppm.
-- Degradates of fludioxonil are highly mobile and may enter both surface and ground water. Based on their low K_oc values, two of the three photolytic degradates identified in the laboratory studies (CGA- 192155 and CGA-339833) are expected to be highly mobile in the environment.
-- there is potential for chronic dietary exposure to fludioxonil in drinking water.
-- Cancer studies (oral, dermal, inhalation): a statistically significant increase, both trend and pairwise, of combined hepatocellular tumors in female rats. The pairwise increase for combined tumors was significant at p=0.03, which is not a strong indication of a positive effect. In addition, the increase in these tumors was within, but at the high end, of the historical controls.
-- Carcinogenicity studies -rats NOAEL = 590 mg/kg/day (M) and 715 mg/kg/day (F). LOAEL: 851 mg/kg/day (M) and 1,008 mg/kg/ day (F) based on reduced survival (F), decreased body weights (M), bile duct hyperplasia (M) and severe nephropathy (both sexes). No evidence of carcinogenicity.

• IR-4 / SYNGENTA - Proposed new tolerances.
• Pesticide Petition (PP) 2E6359 proposes the establishment of a tolerance for the bushberry subgroup, lingonberry, juneberry, and salal at 2.0 ppm,
• PP 2E6365 proposes the establishment of a tolerance for watercress at 7.0 ppm,
• PP 2E6377 proposes the establishment of a tolerance for pistachio at 0.10 ppm and
• PP 2E6393 proposes the establishment of a tolerance for the caneberry subgroup at 5.0 ppm.

NOTE: See EPA's Toxicological profile on Fludioxonil published in the Federal Register on December 29, 2000 (below).

• 7 Pesticide Emergency Exemptions. EPA authorized use in:
• Alabama: on peaches to control brown rot; August 24, 2001 to Sept 30, 2001.
• California: on stone fruit to control brown rot, gray mold rot, and rhizopus rot; April 20, 2001 to Nov 1, 2001.
• California: on pomegranates to control gray mold; July 26, 2001 to Nov 1, 2001.
• Georgia: on peaches and nectarines to control brown rot; April 20, 2001 to Sept 1, 2001.
• New Jersey: on stone fruit to control brown rot, gray mold, and rhizopus rot; June 6, 2001 to Sept 30, 2001.
• Oregon: on peaches to control brown rot, gray mold and Rhizopus rot; June 6, 2001 to Sept 30, 2001.
• South Carolina: on peaches and nectarines to control brown rot; April 20, 2001 to Sept 15, 2001.

• Public Report on Minor Use Pesticides; Notice of Availability.
• "Minor uses of pesticides are those for which the total U.S.acreage for a particular crop is less than 300,000 acres or those for which the use does not provide sufficient economic incentive to support its registration." - see Report cited in the Federal Register which includes the following fluorinated pesticides:
• Bifenthrin Insecticide (Trade names Capture,Brigade,Talstar,Biflex)
• Diflubenzuron Insect Growth Regulator Insecticide (Trade name Dimilin)
• Fludioxonil Fungicide (Trade names Maxim,Medallion)

• Pesticide Tolerances for Emergency Exemptions; for residues in or on pomegranates at 5 ppm. - FINAL RULE. The tolerance will expire and is revoked on June 30, 2003. Objections and requests for hearings, identified by docket control number OPP-301161, must be received by EPA on or before November 13, 2001.
• Study and Toxicological Effects:
• Developmental toxicity study - rat. LOAEL = 1,000 mg/kg/day based on increased incidence of fetuses and litters with dilated renal pelvis and dilated ureter.
• 1 Year chronic toxicity study - dog LOAEL = 35.5 mg/kg/day based on decreased weight gain in female dogs.
• 13 Week Oral Feeding Study - rat Systemic LOAEL = 428 mg/kg/day based on decreased body weight gain in both sexes, chronic nephropathy in males, and centrilobular hepatocyte hypertrophy in females.

NOVARTIS - Pesticide Tolerances for residues in or on Grape at 1 ppm; Onion dry bulb at 0.2 ppm; Onion green at 7 ppm; Strawberry at 2 ppm.- FINAL RULE.

• 90-Day oral toxicity in rats: decreased weight gain (both sexes), chronic nephropathy (Males) and centrilobular hepatocyte hypertrophy (Females).
• 90-Day oral toxicity in mice: decreased body weight gain (F), increased alkaline phosphatase (M), increased relative liver weight, increased incidence of nephropathy and centrilobular hypertrophy (both sexes).
• 90-Day oral toxicity in dogs: increased incidence of diarrhea (both sexes).
• Prenatal developmental in rodents: reduction in corrected weight gain, increase in the fetal incidence and litter incidence of dilated renal pelvis and dilated ureter.
• Prenatal developmental in non-rodents: decreased body weight gain and decreased food efficiency.
• Reproduction and fertility effects: decreased body weights, decreased weight gain, and decreased food consumption in both sexes, reduced pup weights during lactation.
• Chronic toxicity dogs; decreased weight gain (F) and decreased body weight, reduction in hematological parameters (platelets), increase in cholesterol and alkaline phosphatase, and increased relative liver weight (M).
• Combined Chronic Toxicity/ Carcinogenicity in rats: based on decreased mean body weight gain, slight anemia (F), and increased incidence and severity of liver lesions (degeneration) in both sexes. There was no evidence of carcinogenicity in male rats, but there was a statistically significant increase, both trend and pairwise, of combined hepatocellular tumors in female rats. Classified as ``Group D'' by OPP Cancer Peer Review Committee.
• Carcinogenicity mice: increased incidence of mice convulsing when handled (M) and increased absolute liver weight and grossly enlarged livers (F). Statistically significant trend for malignant lymphomas in females.
• In vivo Rat hepatocyte micronucleus assay: Positive for mutagenicity in hepatocytes exposed in vivo.

• Pesticide Emergency Exemptions. US EPA authorized:
• California EPA, Dept of Pesticide Regulation, the use of fludioxonil on peaches, nectarines, apricots and plums to control brown rot, gray mold rot, and Rhizopus rot; 5/1/00 to 11/1/00.
• New Jersey Department of Environmental Protection, the use of fludioxonil on peaches and nectarines to control brown rot, gray mold, and Rhizopus rot; 5/31/00 to 9/30/00.
• Oregon Department of Agriculture, the use of Switch 62.5 WG (containing the active ingredients fludioxonil and cyprodinil) on caneberries to control gray mold; 5/9/00 to 9/10/00. EPA authorized the use of fludioxonil on peaches to control brown rot, gray mold, and Rhizopus rot; 5/31/00 to 9/30/00.
• South Carolina Clemson University, the use of Switch 62.5 WG (containing the active ingredients fludioxonil and cyprodinil) on strawberries to control flower blight and fruit rot; 5/12/00 to 6/15/00.
• Washington Department of Agriculture, the use of Switch 62.5 WG (containing the active ingredients fludioxonil and cyprodinil) on caneberries to control gray mold; 5/9/00 to 9/10/00.

IR-4 (Novartis). Petition for Peticide Tolerances
-- PP 8E5026 proposes the establishment of tolerances for strawberries at 2.0 ppm; dry bulb onion; great-headed garlic; shallot; and welsh onion at 0.2 ppm; and green onion and leek at 7.0 ppm.
-- PP 9E6049 proposes the establishment of a tolerance for stone fruit group at 2.0 ppm.
-- In the Chinese hamster ovary (CHO) cell assay, some clastogenic and polyploidogenic effects were seen at or near the precipitating concentration of the test substance. However, results were negative in the Ames assay, CHO V79 cell assay, hepatocyte DNA repair assay, rat hepatocyte micronucleus test, mouse bone marrow test, and Chinese hamster bone marrow test. A dominant lethal test conducted in the mouse was also negative.
-- Subchronic toxicity. In a 90-day dietary toxicity study the kidney and liver have been identified as target organs. In a subchronic study in rats, the NOAEL was 10 ppm based on liver toxicity. In a subchronic study in mice, the NOAEL was 100 ppm based on blue urine (a metabolite)...

NOVARTIS - Pesticide Tolerance for residues in or on flax seed at 0.05 ppm; and safflower seeds at 0.01 ppm.- FINAL RULE.

NOVARTIS - Application to register Helix Technical, an insecticide/fungicide product. Active ingredients: Thiamethoxam, 4H-1,3,5-oxadiazin-4-imine, 3-[(2-chloro-5- thiazolyl)methyl]tetrahydro-5-methyl-N-nitro- at 20.70%, difenoconazole at 1.25%, (R)-[(2,6-dimethylphenyl)-methoxyacetylamino]-propionic acid methyl ester at 0.38%, and fludioxonil at 0.13%. For use as a seed treatment product to control certain insects and diseases of canola.

• NOVARTIS - Amended Pesticide Tolerance Petition of August 26, 1998. EPA has received an amendment to
• PP 8F4978 from Novartis proposing to amend 40 CFR part 180 by establishing tolerances for residues of fludioxonil in or on the raw agricultural commodities of flax seed at 0.05 parts per million (ppm) and safflower seed at 0.01 ppm.

NOVARTIS - Pesticide Tolerances. - FINAL RULE. This regulation establishes tolerances for residues of fludioxonil in or on the following raw agricultural commodities: rape seed, rape forage, peanuts, meat (hulls removed), peanut hay, sunflower seed, leafy vegetables except brassica, brassica leafy vegetables, legume vegetables, foliage of legume vegetables, fruiting vegetables except cucurbits, cucurbit vegetables, forage, fodder, and straw of cereal grains, grass, forage, fodder, and hay, and non-grass animal feeds at 0.01 ppm; root and tuber vegetables, leaves of root and tuber vegetables, bulb vegetables, cereal grains, and herbs and spices at 0.02 ppm; and cotton seed and cotton gin byproducts at 0.05 ppm.

• NOVARTIS - Two Pesticide Tolerance Petitions.
• PP 7E4919; establishing tolerances for residues of fludioxonil in or on the raw agricultural commodities (RACs): grapes at 1.00 ppm (7E4919);
• PP 8F4978; establishing tolerances for residues in or on the RACs canola, peanuts, sunflowers, leafy vegetables except brassica (Crop Group 4); brassica leafy vegetables (Crop Group 5); legume vegetables (Crop Group 6); foliage of legume vegetables (Crop Group 7); fruiting vegetables (Crop Group 8); cucurbit vegetables (Crop Group 9); forage, fodder, and straw of cereal grains (Crop Group 16); grass , forage, fodder, and hay (Crop Group 17); and non-grass animal feeds (Crop Group 18) at 0.01 ppm; root and tuber vegetables (Crop Group 1); leaves of root and tuber vegetables (Crop Group 2); bulb vegetables (Crop Group 3); cereal grains (Crop Group 15); and herbs and spices (Crop Group 19) at 0.02 ppm; and cotton at 0.05 ppm.

CIBA-GEIGY - Pesticide Tolerance for residues in or on potatoes at 0.02 ppm. - FINAL RULE.

CIBA-GEIGY - Pesticide Tolerance Petition. This notice announces the refiling of a pesticide petition proposing the establishment of a regulation for residues of fludioxonil in or on the raw agricultural commodity potatoes at 0.02 ppm.

CIBA-GEIGY - Pesticide Tolerance Petition for the residues of the fungicide in or on the raw agricultural commodity potatoes (potato tubers) at 0.5 ppm.