Docket #: EPA - HQ - OPP - 2009 - 0774

COMPANY NOTICE OF FILING EPA Registration Division contact: Sidney Jackson, (703) 305 - 761 0 Interregional Research Project No. 4 (IR- 4) PP9E7611 EPA has received a pesticide petiti on PP9E7611 from Interregional Research Project No. 4 (IR- 4 ) , 500 College Road East, Suite 201W, Princeton, NJ 08540 in cooperation with the registrant, Syngenta Crop Protection, Inc., 410 Swing Rd., Greensboro, NC 27419 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. 275 by establishing a tolerance for residues of Chlorothalonil in or on the raw agricultural commodity low growing berries subgroup 13 - 07G at 0.01 parts per million (ppm) ; Bushberry subgroup 13 - 07B at 1 ppm; onion , bulb subgroup 1 3 - 07A at 0.5 ppm; and onion , green subgroup 13 - 07B at 5 ppm . EPA has determined that the petition contains data or information regarding the elements set forth in section 408 (d)(2) of FDDCA; however, EPA has not fully evaluated the sufficiency of the submitted data at this time or whether the data supports granting of the petition. Additional data may be needed before EPA rules on the petition. A. Residue Chemistry

1. Plant metabolism . The metabolism of Chlorothalonil as well as the nature of the residues in plants is adequately understood for purposes of the proposed tolerance. Plant metabolism has been evaluated in five diverse crops: Carrots, celery, lettuce, snap beans, a nd tomatoes, which should serve to define the similar metabolism of Chlorothalonil in a wide range of crops. The qualitative nature of residues in plants for Chlorothalonil is adequately understood. The residue of concern is Chlorothalonil and its metabolite, 4 - hydroxy2,5,6 - trichloroisophthalonitrile (SDS - 3701). Parent metabolite CGA64250 is the major compound found in crops. 2. Analytical method. An adequate residue analytical method (gas chromatography) is available for enforcement purposes. The method is listed in the Pesticide Analytical Manual (PAM) Vol. II (PAM II). 3. Magnitude of residues. All samples were analyzed for residues of Chlorothalonil and its metabolite SDS - 370 1 (R182281 ) . The limit of quantitation (LOQ) for Chlorothalonil a nd SDS - 3701 were 0.030 ppm. i. Strawberries (low growing bush berries except cranberries) : E ight field trials were conducted for this study. The first field trial (Florida 05 -2

FL01 in EPA region 3) was conducted to determine treatment rate and pre - harv est intervals (PHIs) for the additional trials. The seven remaining trials were located in Florida (region 3), California (two trials, region 10), New York (region 1), New Jersey (region 2), Michigan (region 5), and Oregon (region 12). Strawberries were collected from the 05 - FL01 Florida treated plot at the nearly ripe stage, from 29 days after the fifth foliar application in TRT 06 to 62 days after the transplant dip only (TRT 07). Strawberries were collected from the 05 - FL49 Florida and from all Califo rnia trials at the marketable stage, from 70 days after the second application (TRT 12 in 05 - FL49) to 175 days after the transplant dip only (TRT 07 in 05 CA*157). Strawberries were collected from the New York, New Jersey, Michigan, and Oregon treated plo ts at the marketable stage, from 53 days after the final application (TRT 15 in 05 - NY21) to 90 days after the dormant spray only (TRT 13 in 05 OR18). The results from the trials show that no residues of chlorothalonil or SDS - 3701 (R182281 ) were observed in any strawberry sample above the LLMV (0.030 ppm for GC/ECD and 0.010 ppm for GC/MSD) , regardless of treatment scenario or PHI. ii. Bushberry subgroup 13 - 07B The existing tolerance for blueberries is being used to request a tolerance on Crop Subgrou p 13 - 07B ; Bushberry subgroup. iii. Onion subgroups 3 - 07A and 3 - 07B The existing tolerance for bulb onion is being used to request a tolerance on Crop subgroup 3 - 07A ; Onion, bulb subgroup and t he existing tolerance for green onion is being used to reques t a tolerance on Crop subgroup 3 - 07B ; Onion, green subgroup. B. Toxicological Profile 1. Acute toxicity. An assessment of the toxic effects caused by Chlorothalonil is discussed in Unit III.A. and Unit III.B. in the Federal Register of December 3, 2008 ( FR Volume 73, Number 233) ( FRL - 8387 - 9 ) . 2. Genotoxicty. An assessment of the toxic effects caused by Chlorothalonil is discussed in Unit III.A. and Unit III.B. in the Federal Register of December 3, 2008 ( FR Volume 73, Number 233) ( FRL - 8387 - 9 ) . 3. Reproductive and developmental toxicity.

. An assessment of the toxic effects caused by Chlorothalonil is discussed in Unit III.A. and Unit III.B. in the Federal Register of December 3, 2008 (FR Volume 73, Number 233) ( FRL - 8387 - 9 ) . 4. Subchronic toxicity.

. An assessment of the toxic effects caused by Chlorothalonil is discussed in Unit III.A. and Unit III.B. in the Federal Register of December 3, 2008 ( FR Volume 73, Number 233) ( FRL - 8387 - 9 ) . 5. Chronic toxicity.

. An assessment of the toxic effects caused by3

Chlorothalonil is discussed in Unit III.A. and Unit III.B. in the Federal Register of December 3, 2008 ( FR Volume 73, Number 233) ( FRL - 8387 - 9 ) 6. Animal metabolism. The metabolism of chlorothalonil in the rat is adequately understoo d. 7. Metabolite toxicology

. The residues of concern for tolerance setting purposes in or on raw agricultural commodity are the parent compound and its metabolite, 4 - hydroxy- 2,5,6 - trichloroisophthalonitrile (SDS - 3701). The residue of concern in meat and milk is SDS - 3701. 8. Endocrine disruption

. Chlorothalonil does not belong to a class of chemicals known or suspected of having adverse effects on the endocrine system. Developmental toxicity studies in rats and rabbits and a reproduction study in rats gave no indication that chlorothalonil might have any effects on endocrine function related to development and reproduction. The subchronic and chronic studies also showed no evidence of a long - term effect related to the endocrine system. C. A ggregate Exposure 1. Dietary exposure. Tier II/III chronic aggregate and short- term aggregate exposure evaluations were made for chlorothalonil using the Dietary Exposure Evaluation Model software with the Food Commodity Intake Database (DEEM FCIDTM, ve rsion 2.16) from Exponent. Empirically derived processing factors were used for beans (snap, babyfood and cooked, 0.05X), cabbage (0.2X), carrots (babyfood, 0.005X), cherries (babyfood, 0.05X), cherry juice (0.075X), cocoa (0.1X), coffee (0.1X), cranberry juice (0.25X), cucumbers (uncooked cured, 0.2X), peach (cooked, 0.02X), peach (dried cooked, 0.14X), peach (juice, babyfood, 0.02X), peanut oil (prune, 0.5X), plum (prune, 0.33X), soybean oil (0.04X), squash (0.001X), tomato juice (0.25X), and tomato past e/puree (0.02X). All other processing factors were DEEMTM Ver. 7.87 default values. All consumption data for these assessments was taken from the USDA’s Continuing Survey of Food Intake by individuals (CSFII) with the 1994 - 96 consumption database and the Supplemental CSFII children’s survey (1998) consumption database. These assessments included all current and pending uses plus a proposed new IR 4 pre plant dip and foliar combination use on strawberries. Residue data for current and pending registratio ns were obtained from a number of sources including field trial data and monitoring data from the Pesticide Data Program (PDP), FoodContam (FC), and the FDA monitoring program. The current tolerance definition expression for chlorothalonil includes chloro thalonil plus the metabolite SDS3701. Since residue values for chlorothalonil in the PDP and other monitoring databases may not include residues of the SDS3701 metabolite, samples that had detectable residues of chlorothalonil were conservatively assigned a value of 10% of the reported chlorothalonil residue for an assumed residue of SDS3701, based upon the maximum ratio of metabolite SDS3701 to chlorothalonil in radio - labeled plant studies (6.5%). A proposed tolerance of 0.02 ppm was used for the propose d use on strawberries. Percent of crop treated values4

were estimated based upon economic, pest and competitive pressures. Tolerance level residues were assumed for all meat commodities. For milk and milk derived commodities, relevant PDP monitoring data base residue values were used. i. Food. [ Acute dietary (food only) assessments were not performed, since an endpoint of concern attributable to a single oral dose has not been identified. Food Chronic Exposure : The chlorothalonil chronic dietary (food only) risk assessment was performed for all population subgroups using a chronic reference dose of 0.02 mg/kg - bw/day, based upon a NOAEL of 2.0 mg/kg - bw/day from a chronic rat toxicity study and an uncertainty factor of 100X for intra - and inter species v ariability; no additional FQPA safety factor was applied. For the purpose of the aggregate risk assessment, exposure values were expressed in terms of margin of exposure (MOE), calculated by dividing the 2.0 mg/kg - bw/day endpoint by the exposure for each population subgroup. In addition, exposures were expressed as a percent of the chronic reference dose (%cRfD). Chronic dietary (food only) exposure to the U.S. population resulted in a MOE of 10,033 (1.0% of the cRfD). The most sensitive sub - population was children 1 - 2 years old, with a MOE of 6,178 (1.6% of the cRfD). Since the Benchmark MOE for this assessment was 100 and since EPA generally has no concern for exposures above the benchmark or below 100% of the reference dose, Syngenta believes that th ere is a reasonable certainty that no harm will result from dietary (food) exposure to residues arising from all current, pending, and proposed uses of chlorothalonil. Cancer. Chlorothalonil is listed as “likely” to be a human carcinogen by all routes of exposure, however the SAP decision of 6/30/98 supports the use of a MOE approach. The HASPOC deliberated on 3/12/08 and supported the MOE approach. ii. Drinking water

. [ Estimated Drinking Water Concentrations (EDWCs) for chlorothalonil TTR were calculated for the currently registered uses and the proposed uses on strawberries and citrus using the Tier II Model PE5, PRZM (Pesticide Root Zone Model) / EXAMS (Exposure Analysis Modeling Systems), to provide surface water exposure estimates and the Tier 1 Model, SCI - GROW (Screening Concentration In GROund Water), to provide ground water exposure estimates. For surface water, the currently registered Bravo Weather Stik® use on tomatoes was the driving crop use and provided the highest EDWCs, exceeding the propose d new IR- 4 crop uses for strawberries and citrus. The use parameters for chlorothalonil on tomatoes consisted of seven aerial applications of 2.1 lbs chlorothalonil / A, and this use was modeled using the PRZM Crop Scenarios: CA, FL and PA Tomatoes. PRZM/EXAMS modeling provided an annual average (chronic) surface water EDWC of 72.9 ppb. For ground water the currently registered use, Daconil Ultrex® on golf course turf (greens), was the driving crop use and provided higher EDWCs than the proposed uses for strawberries and citrus. The application parameters for Daconil Ultrex® consisted of ten ground applications of 7.3 lbs. ai / A which provided an EDWC (acute and chronic) of 6.85

ppb for chlorothalonil TTR. Since the surface water EDWC exceeds the ground water EDWC, the surface water value should be used for comparison purposes and is considered protective for any ground water concentration concerns. Acute Exposure from Drinking Water: Acute drinking water assessments were not performed, since an end point of concern attributable to a single oral dose has not been identified. Chronic Exposure from Drinking Water: The chronic EDWC of 72.9 ppb (0.0729 ppm) was used to calculate the chronic drinking water exposure values for the U.S. Population and all population subgroups. Chronic drinking water exposures to the U.S. Population resulted in a MOE of 1,302 (7.7% of the cRfD). The most sensitive sub - population was all infants <1 year, with a MOE of 397 (25.2% of the cRfD). Since the Benchmark MOE for th is assessment was 100 and since EPA generally has no concern for exposures above the benchmark or below 100% of the reference dose, Syngenta believes that there is a reasonable certainty that no harm will result from dietary (food) exposure to residues ari sing from all current, pending, and proposed uses of chlorothalonil. 2. Non

- dietary exposure

. Chlorothalonil is a broad spectrum fungicide that can be applied to ornamentals and non - residential turfgrass and can also be formulated into paints for interior and exterior applications. There is a potential for residential exposure to adult handlers making applications to ornamentals and/or from using treated paint. There is also a potential for residential exposure to children from ingestion of paint chip s containing chlorothalonil, although ingestion of paint chips is considered to be episodic in nature and is generally not included in aggregate risk so it was therefore excluded from these assessments as well. The chlorothalonil non - dietary risk assessme nt was performed using a short- term incidental oral and inhalation endpoint of 3.0 mg/kg - bw/day, based upon a NOAEL from a 90 day rat study in the rat and an uncertainty factor of 100X for intra - and inter- species variability; no additional FQPA safety fac tor was applied. For the purpose of the aggregate risk assessment, exposure values were expressed in terms of margin of exposure (MOE), calculated by dividing the 3.0 mg/kg - bw/day endpoint by the exposure for each population subgroup. The most exposed po pulation subgroups from the non - dietary (residential) assessments was for male adults and youths (13 years and older) attributable to short- term inhalation exposures resulting from applying alkyd exterior paint with an airless sprayer, with a MOE of 147. Since the benchmark MOE for this assessment was 100 and since EPA generally has no concern for non - dietary exposures above the benchmark MOE, Syngenta believes that there is a reasonable certainty that no harm will result from non - dietary exposures from all current residential uses for chlorothalonil. D. Cumulative Effects Cumulative Exposure to Substances with a Common Mechanism of Toxicity. Section 408(b)(2)(D)(v) requires that, when considering whether to establish,6

modify, or revoke a tolerance, the Agency consider “available information” concerning the cumulative effects of a particular pesticide’s residues and “other substances that have a common mechanism of toxicity”. Syngenta did not perform a cumulative risk assessment as part of this tole rance action for chlorothalonil because HED has not yet determined that there are any other chemical substances that have a mechanism of toxicity common with that of chlorothalonil. For purposes of this tolerance action, EPA has assumed that chlorothaloni l does not have a common mechanism of toxicity with any other substance(s). E. Safety Determination 1. U.S. population. The chronic aggregate exposure analysis (food plus water exposures) showed that exposure from all established and proposed uses o f chlorothalonil resulted in a chronic MOE of 1,152 (8.7% of the cRfD) which exceeds the benchmark MOE of 100. The short- term aggregate exposure analysis (food plus water plus non - dietary residential exposures) showed that exposure from all established an d proposed uses of chlorothalonil resulted in a MOE of 136 for adults 50 years and older, which exceeds the benchmark MOE of 100. Based on the completeness and reliability of the toxicity data supporting these petitions, Syngenta believes that there is a reasonable certainty that no harm will result to the U. S. population from aggregate exposures arising from all current, pending, and proposed uses for chlorothalonil. 2. Infants and children

. The chronic aggregate exposure analysis (food plus water exposures) showed that exposure from all established and proposed uses of chlorothalonil resulted in a MOE of 390 (25.6% of the cRfD) for all infants <1 year old, which exceeds the benchmark MOE of 100. The short- term aggregate exposure analysis (food plus water plus non - dietary residential exposures) showed that exposure from all established and proposed uses of chlorothalonil resulted in a MOE of 585 for infants <1 year old, which exceeds the benchmark MOE of 100. Based on the completeness and reliability of the toxicity data supporting these petitions, Syngenta believes that there is a reasonable certainty that no harm will result to infants and children from aggregate exposures arising from all current, pending, and proposed uses for chlorothalonil. F . International Tolerances Maximum Residue Levels (MRLs) for chlorothalonil have been established in a number of countries including Argentina, Australia, Brazil, Canada, Chile, China, France, Germany, Italy, Russia, and Spain. Compatibility between U .S. tolerances and Codex MRLs exist for beans/peas/dry beans, broccoli, brussel sprouts, carrots, celery , cherries, cranberries, cucumbers, melons, onions, peaches, squash, and tomatoes. Some incompatibilities exist between Codex MRLs and U.S. tolerances for bananas, cabbage, cauliflower, peanuts, and sweet corn. No questions of compatibility exist with re spect to commodities where no Codex MRLs have been established but U.S. tolerances exist, or where Codex MRLs have been established but U.S. tolerances do not exist.7