Propiconazole Dietary Exposure Assessment DP Barcode: D329667 PC Code: 122101 Page: 1 of 20 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D. C. 20460 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES MEMORANDUM DATE: June 15, 2006 SUBJECT: Propiconazole Revised Acute and Chronic Dietary Exposure Assessments for Reregistration Evaluation Decision ( RED) Phase 4.

PC Code: 122101 DP : 329667 REVIEWER: Yan Donovan, Chemist Reregistration Branch 4/ Health Effects Division ( 7505C)

THROUGH: William Cutchin, Chemist Thurston Morton, Chemist Dietary Exposure Science Advisory Council ( DESAC) Health Effects Division ( 7509C)

TO: Yan Donavon, Risk Assessor Reregistration Branch 4/ Health Effects Division ( 7505C)

Executive Summary Revised acute and chronic dietary risk assessments were conducted incorporating comments from phase 2 comments period for propiconazole RED. As a result of the phase 2 comments, drinking water numbers have been revised. New tolerance on rice bran was proposed based on the Agency's review of the rice processing study. New acute dietary endpoints and aPADs were selected based on the review of the recently submitted acute neurotoxicity study.

The acute and chronic dietary assessment used the Dietary Exposure Evaluation Model ( DEEMFCIDTM Version 2.03) which uses food consumption data from the USDA's Continuing Surveys of Food Intakes by Individuals ( CSFII) from 1994 1996 and 1998. The analyses were performed to support the RED for the use of propiconazole. Propiconazole Dietary Exposure Assessment DP Barcode: D329667 PC Code: 122101 Page: 2 of 20 Acute Dietary Exposure Results and Characterization An acute dietary analysis for propiconazole was conducted using tolerance levels and 100 % CT for all existing and proposed uses. The acute PAD is 0.3 mg/ kg/ day for all population subgroups ( includes females 13 49 years). The results of the analysis indicate that acute risk from the dietary exposure ( food and water) to propiconazole from the requested uses did not exceed HED's level of concern for the U. S. population or any population subgroup. The exposure to the U. S. population is 3% aPAD, the highest exposure is to all infants < 1 yrs old, at 8% aPAD.

Chronic Dietary Exposure Results and Characterization A chronic dietary analysis for propiconazole was conducted using tolerance levels and 100 % CT for all existing and proposed uses. The results of the analysis indicate that chronic risk from the dietary exposure ( food and water) to propiconazole from the requested use did not exceed HED's level of concern for the U. S. population or any population subgroup. The exposure to the U. S. population was 3% cPAD and the most highly exposed subgroup, Children 1 2 yrs old, at 8% cPAD.

Cancer Dietary Exposure Results and Characterization The HIARC classified propiconazole as a Group C  possible human carcinogen, non quantifiable, and, therefore, quantification of human cancer risk is not required.

Water Contribution The highest estimates from surface water ( acute, 86.4 ppb and chronic, 37.5 ppb) were used in the DEEM analysis.

I. Introduction Dietary risk assessment incorporates both exposure and toxicity of a given pesticide. For acute and chronic assessments, the risk is expressed as a percentage of a maximum acceptable dose ( i. e., the dose which HED has concluded will result in no unreasonable adverse health effects). This dose is referred to as the population adjusted dose ( PAD). The PAD is equivalent to the Reference Dose ( RfD) divided by the special FQPA Safety Factor.

For acute and non cancer chronic exposures, HED is concerned when estimated dietary risk exceeds 100% of the PAD. HED is generally concerned when estimated cancer risk exceeds one in one million ( i. e., the risk exceeds 1 x 10 6). References which discuss the acute and chronic risk assessments in more detail are available on the EPA/ pesticides web site: AAvailable Information on Assessing Exposure from Pesticides, A User's Guide, 6/ 21/ 2000, web link: http:// www. epa. gov/ fedrgstr/ EPA PEST/ 2000/ July/ Day 12/ 6061. pdf ; or see SOP 99.6 ( 8/ 20/ 99). Propiconazole Dietary Exposure Assessment DP Barcode: D329667 PC Code: 122101 Page: 3 of 20 The most recent dietary risk assessment for propiconazole was conducted by D. Hrdy supporting the primary human health risk assessment for propiconazole ( HED memo of D. Hrdy, D318269, 08/ 18/ 05).

II. Residue Information Dietary Exposure These acute and chronic assessments were based on the assumption of tolerance level residues for all commodities with existing and proposed tolerances and 100% crop treated (% CT) for all commodities. The existing tolerances are listed in 40 CFR § 180.434. This dietary analysis included all reassessed and proposed tolerances outlined in Table 1 below, which is from the revised residue chemistry summary chapter for propiconazole by Y. Donovan, 06/ 15/ 06, D329394.

DEEM default processing factors from DEEM ( Version 7.81) were used for all processed commodities that do not have individual tolerances.

Table 1. Tolerance Reassessment Summary for Propiconazole.

Commodity Current Tolerance, ppm Reassessed Tolerance, ppm Comment [ Correct Commodity Definition]

Tolerances Established Under 40 CFR § 180.434( a)

Bananas 0.2 0.2 [ Banana]

Barley, grain 0.1 0.3 Translated from wheat data. Memo of 02/ 02/ 05, Y. Donovan, D271790.

Barley, straw 1.5 15.0 Translated from wheat data. Memo of 02/ 02/ 05, Y. Donovan, D271790.

Cattle, fat 0.1 0.1 0.08 ppm combined residues in fat were expected from MTDB.

Cattle, kidney 2.0 2.0 1.01 ppm combined residues in kidney were expected from MTDB. However, several new uses are pending which may increase the MTDB. Propiconazole Dietary Exposure Assessment DP Barcode: D329667 PC Code: 122101 Page: 4 of 20 Table 1. Tolerance Reassessment Summary for Propiconazole.

Commodity Current Tolerance, ppm Reassessed Tolerance, ppm Comment [ Correct Commodity Definition]

Cattle, liver 2.0 2.0 1.33 ppm combined residues in liver were expected from MTDB. However, several new uses are pending which may increase the MTDB.

Cattle, meat byproducts, except kidney and liver 0.1 0.1 ( see comments above in fat)

Cattle, meat 0.1 0.1 0.04 ppm combined residues in meat were expected from MTDB. However, several new uses are pending which may increase the MTDB.

Celery 5.0 5.0 Corn, field, stover 12 12 Expiration date 11/ 30/ 08 [ Corn, field, stover]

Corn, field, forage 12 12 Expiration date 11/ 30/ 08 [ Corn, field, forage]

Corn, field, grain 0.1 0.1 Expiration date 11/ 30/ 08 [ Corn, field, grain]

Corn, sweet, kernels plus cobs with husks removed 0.1 0.1 Expiration date 11/ 30/ 08 [ Corn, sweet, kernels plus cobs with husks removed]

Eggs 0.1 Revoke Feeding study data indicate that tolerances for poultry commodities are not necessary.

Fruit, Stone, group 12 1.0 1.0 [ Fruit, stone, group 12]

Goat, fat 0.1 0.1 ( see comments in cattle)

Goat, kidney 2.0 2.0 ( see comments in cattle)

Goat, liver 2.0 2.0 ( see comments in cattle)

Goat, meat byproducts, except kidney and liver 0.1 0.1 ( see comments in cattle) Propiconazole Dietary Exposure Assessment DP Barcode: D329667 PC Code: 122101 Page: 5 of 20 Table 1. Tolerance Reassessment Summary for Propiconazole.

Commodity Current Tolerance, ppm Reassessed Tolerance, ppm Comment [ Correct Commodity Definition]

Goat, meat 0.1 0.1 ( see comments in cattle)

Grass, forage 0.5 0.5 Grass, hay ( straw) 40 40 [ Grass, hay]

Grass, straw 40 40 [ Grass, straw]

Hog, fat 0.1 0.1 ( see comments in cattle)

Hog, kidney 2.0 2.0 ( see comments in cattle)

Hog, liver 2.0 2.0 ( see comments in cattle)

Hog, meat byproducts, except kidney and liver 0.1 0.1 ( see comments in cattle)

Hog, meat 0.1 0.1 ( see comments in cattle)

Horse, fat 0.1 0.1 ( see comments in cattle)

Horse, kidney 2.0 2.0 ( see comments in cattle)

Horse, liver 2.0 2.0 ( see comments in cattle)

Horse, mbyp ( except kidney and liver) 0.1 0.1 [ Horse, meat byproducts, except kidney and liver]( see comments in cattle)

Horse, meat 0.1 0.1 ( see comments in cattle)

Milk 0.05 0.05 0.03 ppm combined residues in milk were expected from 26.5ppm MTDB.

Mushroom 0.1 0.1 Use of propiconazole on mushrooms is being supported by IR 4. Currently there are no registered uses of propiconazole on mushrooms. [ Mushroom]

Oat, forage 10.0 10.0 [ Oat, forage]

Oat, grain 0.1 0.1 [ Oat, grain]

Oat, hay 30.0 2.0 Translated from wheat hay. [ Oat, hay]

Oat, straw 1.0 1.0 [ Oat, straw] Propiconazole Dietary Exposure Assessment DP Barcode: D329667 PC Code: 122101 Page: 6 of 20 Table 1. Tolerance Reassessment Summary for Propiconazole.

Commodity Current Tolerance, ppm Reassessed Tolerance, ppm Comment [ Correct Commodity Definition]

Peanut 0.2 0.2 Expiration date 11/ 30/ 08 [ Peanut]. Parent accounted 30% of the TRR based on peanut metabolism ( MARC memo of 4/ 4/ 02, D279299).

Peanut, hay 20.0 20.0 Expiration date 11/ 30/ 08 [ Peanut, hay]

Pecans 0.1 0.1 Syngenta has proposed removal of the established tolerance for pecans on establishment of the proposed tree nut crop group tolerance ( pending tolerance petition PP# 9F3470).

Pineapple 0.1 0.1 Expiration date 11/ 30/ 08 Pineapple, fodder 0.1 Revoke Expiration date 11/ 30/ 08; no longer considered a significant livestock feed item.

Plum, prune, fresh 1.0 Revoke This tolerance has been replaced by the stone fruits group tolerance.

Rice, grain 0.1 0.3 The available data, reflecting the maximum registered use pattern, indicate that the maximum combined residues of propiconazole and its metabolites determined as 2,4 DCBA were 0.28 ppm in/ on rice grain. ( HED memo of 02/ 23/ 05, T. Morton, D240856).

Rice, straw 3.0 3.0 ( HED memo of 02/ 23/ 05, T. Morton, D240856).

Rye, grain 0.1 0.3 Translated from wheat data. Memo of 02/ 02/ 05, Y. Donovan, D271790.

Rye, straw 1.5 15.0 Translated from data for wheat straw.

Sheep, fat 0.1 0.1 ( see comments in cattle)

Sheep, kidney 2.0 2.0 ( see comments in cattle)

Sheep, liver 2.0 2.0 ( see comments in cattle) Propiconazole Dietary Exposure Assessment DP Barcode: D329667 PC Code: 122101 Page: 7 of 20 Table 1. Tolerance Reassessment Summary for Propiconazole.

Commodity Current Tolerance, ppm Reassessed Tolerance, ppm Comment [ Correct Commodity Definition]

Sheep, mbyp ( except kidney and liver) 0.1 0.1 ( see comments in cattle)

Sheep, meat 0.1 0.1 ( see comments in cattle)

Wheat, grain 0.1 0.30 Memo of 02/ 02/ 05, Y. Donovan, D271790.

Wheat, straw 1.5 15.0 Memo of 02/ 02/ 05, Y. Donovan, D271790.

Tolerances To Be Proposed Under 40 CFR § 180.434( a)

Aspirated grain fractions 20 ( sorghum) 1 5.0 Memo of 02/ 02/ 05, Y. Donovan, D271790. [ Grain, aspirated fraction]

Barley, hay None established 2.0 Translate from wheat hay Corn, pop, grain None established 0.1 Translate from field corn Corn, pop, stover None established 12 Translate from field corn Corn, sweet, forage None established 12 Translate from field corn Corn, sweet, stover None established 12 Translate from field corn Rice, bran None established 1.0 Concentration factor for rice bran is 2.9x. ( MRID45080811. DER2)

Rice, hulls None established 1.2 Concentration factor for rice hulls is 3.8x. ( MRID45080811. DER2)

Rye, forage None established 2.0 Memo of 02/ 02/ 05, Y. Donovan, D271790.

Wheat forage None established 2.0 Memo of 02/ 02/ 05, Y. Donovan, D271790. [ wheat, forage]

Wheat hay None established 2.0 Memo of 02/ 02/ 05, Y. Donovan, D271790. [ Wheat, hay]

Wheat Bran None established 1.0 Memo of 02/ 02/ 05, Y. Donovan, D271790. [ Wheat, bran]

Tolerances Established Under 40 CFR § 180.434( b) Propiconazole Dietary Exposure Assessment DP Barcode: D329667 PC Code: 122101 Page: 8 of 20 Table 1. Tolerance Reassessment Summary for Propiconazole.

Commodity Current Tolerance, ppm Reassessed Tolerance, ppm Comment [ Correct Commodity Definition]

Blueberry 1.0 N/ A Expiration date 11/ 31/ 07. Recommended in Agency memo of 02/ 22/ 05, D. Rate, D313289. [ Blueberry]

Cranberry 1.0 N/ A Expiration date 12/ 31/ 05 [ Cranberry]

Dry bean forage 8.0 N/ A Expiration date 12/ 31/ 05 [ Bean, dry, forage]

Dry bean hay 8.0 N/ A Expiration date 12/ 31/ 05 [ Bean, dry, hay]

Dry bean 0.5 N/ A Expiration date 12/ 31/ 05 [ Bean, dry]

Sorghum, aspirated grain fractions 20 N/ A Expiration date 06/ 30/ 05 Sorghum, grain, grain 0.2 N/ A Expiration date 06/ 30/ 05 [ Sorghum, , grain, grain]

Sorghum, grain, stover 1.5 N/ A Expiration date 06/ 30/ 05 Soybean, bean 0.5 ( pending) N/ A Agency memo of 04/ 14/ 04, J. R. Tomerlin, D262299.

Soybean, forage 8.0 ( pending) N/ A Agency memo of 04/ 14/ 04, J. R. Tomerlin, D262299.

Soybean, hay 25.0 ( pending) N/ A Agency memo of 04/ 14/ 04, J. R. Tomerlin, D262299.

Tolerances Established Under 40 CFR § 180.434( c)

Sunflower None established TBD 2 Peppermint, tops; [ Spearmint, tops 0.3 0.3 Regional registration for use west of the Cascade Mountains only. [ Peppermint, tops] [ Spearmint, tops]

Rice, wild 0.5 0.5 MN [ Rice, wild] Propiconazole Dietary Exposure Assessment DP Barcode: D329667 PC Code: 122101 Page: 9 of 20 1 The 20 ppm tolerance for sorghum aspirated grain fractions is a time limited tolerance to support a Section 18 Exemption.

2 Tolerance can not be established until field data are submitted. Propiconazole Dietary Exposure Assessment DP Barcode: D329667 PC Code: 122101 Page: 10 of 20 Water Exposure ( EFED memo of Jim Lin, 07/ 07/ 06, D361358)

With the exception of rice use, estimated drinking water concentrations from surface water sources were calculated using Tier II PRZM ( Pesticide Root Zone Model) and EXAMS ( Exposure Analysis Modeling System). PRZM is used to simulate pesticide transport as a result of runoff, erosion, and off target spray drift from an agricultural field and EXAMS estimates environmental fate and transport of pesticides in surface water. These models are run using the linkage program shell, PE4V01, which incorporates the standard scenarios developed by EFED.

Linked crop specific scenarios and meteorological data were used to estimate exposure as a result of uses on various field crops and vegetables. Simulations were done using the Index Reservoir scenario in EXAMS, which is designed after an actual reservoir for a drinking water source drawn from surface water. Weather and agricultural practices are simulated over 30 years so that the 1 in10 year exceedence probability at the site can be estimated. The values generated by the models for drinking water were multiplied by a crop area factor ( PCA), which represents the maximum extent to which HUC 8 watersheds in the continental US are planted to agricultural crops.

For Rice Use, the Policy for Estimating Aqueous Concentrations from Pesticides Labeled for Use on Rice, dated October 29, 2002, was followed in estimating drinking water concentrations from rice use. The estimated environmental concentration ( EEC in ug/ L) represents the dissolved concentration occurring in the water column and the concentration in water released from the paddy. Movement of pesticide on suspended sediment is not considered Based on the PRZM EXAMS and SCI GROW models, for surface water, the highest estimated environmental concentrations ( EECs) of propiconazole for acute exposure is 86.4 parts per billion ( ppb) ( rice use), and for chronic exposure is 37.5 ppb ( turf use). For ground water, the highest EEC for acute and chronic exposure is 0.7 ppb. The highest estimates from surface water ( acute, 86.4 ppb and chronic exposure, 37.5 ppb) were used in the DEEM analysis.

Table 2   Estimated Drinking Water Concentrations from Surface Water Sources Pre PAC Adjustment Post PCA Adjustment Use Scenario 1 in 10 probability peak ( Acute) 1 in 10 probability yearly ( Chronic) 1 in 10 probability peak ( Acute) 1 in 10 probability yearly ( Chronic)

Wheat / ND 5.92 ( ug/ L) 2.81 ( ug/ L) 3.32 ( ug/ L) 1.57 ( ug/ L) Propiconazole Dietary Exposure Assessment DP Barcode: D329667 PC Code: 122101 Page: 11 of 20 Grass Seed / OR 4.23 2.07 3.68 1.80 Rice peak conc: 86.40 ug/ L and annual mean conc.: 2.92 ug/ L Pecans / GA 19.56 4.84 17.02 4.21 Peaches / GA 6.59 2.44 5.73 2.12 Sweet Corn / FL 19.26 3.24 8.86 1.49 Sweet Corn / OR 4.23 2.07 1.95 0.95 Dry Beans / MI 8.21 4.37 7.14 3.80 Peanuts / NC 10.34 3.43 9.00 2.98 Barley ( use ND Wheat Sceanrio) 3.14 1.36 2.73 1.18 Celery ( use FL Carrots Scenario) 13.64 2.66 11.87 2.31 Turf / PA 87.89 43.13 76.46 37.52 Turf / FL 75.03 30.50 65.28 26.54 III. DEEM FCIDJ Program and Consumption Information Propiconazole acute and chronic dietary exposure assessments were conducted using the Dietary Exposure Evaluation Model software with the Food Commodity Intake Database ( DEEMFCIDJ Version 2.03), which incorporates consumption data from USDA= s Continuing Surveys of Food Intakes by Individuals ( CSFII), 1994 1996 and 1998. The 1994 96, 98 data are based on the reported consumption of more than 20,000 individuals over two non consecutive survey days. Foods Aas consumed@ ( e. g., apple pie) are linked to EPA defined food commodities ( e. g. apples, peeled fruit  cooked; fresh or N/ S; baked; or wheat flour  cooked; fresh or N/ S, baked) using publicly available recipe translation files developed jointly by USDA/ ARS and EPA. For chronic exposure assessment, consumption data are averaged for the entire U. S. population and within population subgroups, but for acute exposure assessment are retained as individual consumption events. Based on analysis of the 1994 96, 98 CSFII consumption data, which took into account dietary patterns and survey respondents, HED concluded that it is most appropriate to report risk for the following population subgroups: the general U. S. population, all infants (< 1 year old), children 1 2, children 3 5, children 6 12, youth 13 19, adults 20 49, females 13 49, and adults 50+ years old.

For chronic dietary exposure assessment, an estimate of the residue level in each food or food Propiconazole Dietary Exposure Assessment DP Barcode: D329667 PC Code: 122101 Page: 12 of 20 form ( e. g., orange or orange juice) on the food commodity residue list is multiplied by the average daily consumption estimate for that food/ food form to produce a residue intake estimate. The resulting residue intake estimate for each food/ food form is summed with the residue intake estimates for all other food/ food forms on the commodity residue list to arrive at the total average estimated exposure. Exposure is expressed in mg/ kg body weight/ day and as a percent of the cPAD. This procedure is performed for each population subgroup.

For acute exposure assessments, individual one day food consumption data are used on an individual by individual basis. The reported consumption amounts of each food item can be multiplied by a residue point estimate and summed to obtain a total daily pesticide exposure for a deterministic exposure assessment, or Amatched in multiple random pairings with residue values and then summed in a probabilistic assessment. The resulting distribution of exposures is expressed as a percentage of the aPAD on both a user ( i. e., only those who reported eating relevant commodities/ food forms) and a per capita ( i. e., those who reported eating the relevant commodities as well as those who did not) basis. In accordance with HED policy, per capita exposure and risk are reported for all tiers of analysis. However, for tiers 1 and 2, any significant differences in user vs. per capita exposure and risk are specifically identified and noted in the risk assessment.

IV. Toxicological Information HED's Hazard Identification Assessment Review Committee ( HIARC) concluded that the toxicology database for propiconazole is complete for FQPA assessment. Endpoints and dose response have been selected for acute, chronic dietary, short and intermediate term dermal, inhalation, and incidental oral, and long term dermal and inhalation exposures.

The HIARC also concluded that the database was adequate to characterize any potential for prenatal or postnatal risk for infants and children. There is low concern for pre and/ or postnatal toxicity resulting from exposure to propiconazole, and no residual uncertainties were identified. The Special FQPA factor is thus 1X. The HIARC had previously determined that an acute neurotoxicity ( ACN) study was required based on neurotoxic signs in pregnant rats administered high propiconazole doses ( 360 mg/ kg/ day) during gestation. HIARC had determined that for acute ( single dose) and short term exposure scenarios a 3X database uncertainty factor ( UFDB) was adequate to account for the lack of the ACN. In September, 2005 the ACN was submitted to the Agency and reviewed. The study confirms that neurotoxic signs are observed at high doses, but there was no neuropathology and there were no effects on neurobehavioral parameters. Accordingly, the propiconazole risk assessment team determined that a developmental neurotoxicity study was not necessary and the database uncertainty factor for acute and shortterm scenarios was removed. Propiconazole Dietary Exposure Assessment DP Barcode: D329667 PC Code: 122101 Page: 13 of 20 The HED Carcinogenicity Peer Review Committee ( CPRC) classified propiconazole as Group C  possible human carcinogen and recommended that for the purpose of risk characterization the reference Dose ( RfD) approach should be used and would be protective.

Table 3. Summary of Toxicological Doses and Endpoints for Propiconazole for Use in Human Risk Assessments Exposure Scenario Dose Used in Risk Assessment, UF Special FQPA SF* and Level of Concern for Risk Assessment Study and Toxicological Effects Acute Dietary ( Females 13 49) Dev. NOAEL = 30 mg ai/ kg/ day UF = 100 Acute RfD = 0.3 mg/ kg/ day FQPA SF = 1X aPAD = acute RfD FQPA SF = 0.3 mg/ kg/ day Developmental Toxicity Study  Rats. Developmental toxicity: increased incidence of rudimentary ribs, cleft palate malformations ( 0.3%) unossified sternebrae, as well as increased incidence of shortened and absent renal papillae.

Acute Dietary ( General Population including infants and children) NOAEL = 30 mg kg/ day UF = 100 Acute RfD = 0.3 mg/ kg/ day FQPA SF = 1X aPAD = acute RfD FQPA SF = 0.3 mg/ kg/ day Acute Neurotoxicity Study   Rats.

Clinical signs ( piloerection, diarrhea, tiptoe gait).

Chronic Dietary ( All populations) NOAEL = 10 mg ai/ kg/ day UF = 100 Chronic RfD = 0.1 mg/ kg/ day 1X cPAD = chronic RfD FQPA SF = 0.1 mg/ kg/ day 24 Month Oncogenicity Study  Mice. Liver toxicity ( increased liver weight in males and increase in liver lesions ( masses/ raised areas/ swellings/ nodular areas mainly)

Cancer ( Oral, dermal, inhalation) Group C, possible human carcinogen, RfD approach for risk characterization.

UF = uncertainty factor, FQPA SF = Special FQPA safety factor, NOAEL = no observed adverse effect level, LOAEL = lowest observed adverse effect level, PAD = population adjusted dose ( a = acute, c = chronic) RfD = reference dose, MOE = margin of exposure, LOC = level of concern, NA = Not Applicable NOTE: The Special FQPA Safety Factor recommended by the HIARC assumes that the exposure databases ( dietary food, drinking water, and residential) are complete and that the risk assessment for each potential exposure scenario includes all metabolites and/ or degradates of concern and does not underestimate the potential risk for infants and children. Propiconazole Dietary Exposure Assessment DP Barcode: D329667 PC Code: 122101 Page: 14 of 20 V. Results/ Discussion As stated above, for acute and chronic dietary assessments, HED is concerned when dietary risk exceeds 100% of the PAD. The DEEM FCID TM analyses estimate the dietary exposure of the U. S. population and various population subgroups. The exposure results reported in Tables 4 and 5 are for the general U. S. Population, all infants (< 1 year old), children 1 2, children 3 5, children 6 12, youth 13 19, females 13 49, adults 20 49, and adults 50+ years. The acute exposure results reported in Table 4 include at the 95th percentile the general US population at 3 % aPAD and the most highly exposed subgroup, all infants < 1 yrs old, at 8% aPAD. The chronic dietary risk estimates in Table 5 include general US population at 3% cPAD and the most highly exposed subgroup, Children 1 2 yrs old, at 8% cPAD. All the dietary risk estimates are below 100% of the PADs. A determination of cancer dietary risk was not required. These analyses are highly conservative, Tier 1 dietary exposure assessments. Further refinement to the analyses could be made through the use of anticipated residues, incorporation of percentages of crops treated with propiconazole, and/ or monitoring data that better reflect residues at the time of consumption. Since risk estimates are well below HED's level of concern, a more highly refined analysis is not needed at this time. Propiconazole Dietary Exposure Assessment DP Barcode: D329667 PC Code: 122101 Page: 15 of 20 Table 4. Results of Acute Dietary Exposure Analysis for FOOD and Water 95th Percentile 99th Percentile 99.9th Percentile Population Subgroup aPAD ( mg/ kg/ day) Exposure ( mg/ kg/ day) % aPAD Exposure ( mg/ kg/ day) % aPAD Exposure ( mg/ kg/ day) % aPAD General U. S. Population 0.3 0.00965 3.2 0.01595 5.3 0.02798 9.3 All Infants (< 1 year old) 0.3 0.02352 7.8 0.03109 10 0.04693 15 Children 1 2 years old 0.3 0.01843 6.1 0.02936 9.8 0.05908 20 Children 3 5 years old 0.3 0.01556 5.2 0.02209 7.4 0.03597 12.

Children 6 12 years old 0.3 0.01074 3.6 0.01678 5.6 0.02691 9.0 Youth 13 19 years old 0.3 0.00700 2.3 0.01107 3.7 0.01793 6.0 Adults 20 49 years old 0.3 0.00730 2.4 0.01090 3.6 0.01792 6.0 Adults 50+ years old 0.3 0.00700 2.3 0.01029 3.4 0.01605 5.4 Females 13 49 years old 0.3 0.00725 2.4 0.01076 3.6 0.01597 5.3 Table 5. Results of Chronic Dietary Exposure Analysis for FOOD and Water Population Subgroup cPAD ( mg/ kg/ day) Exposure ( mg/ kg/ day) % cPAD General U. S. Population 0.1 0.003113 3.1 All Infants (< 1 year old) 0.1 0.006597 6.6 Children 1 2 years old 0.1 0.007753 7.8 Children 3 5 years old 0.1 0.006464 6.5 Children 6 12 years old 0.1 0.004314 4.3 Youth 13 19 years old 0.1 0.002627 2.6 Adults 20 49 years old 0.1 0.002510 2.5 Adults 50+ years old 0.1 0.002490 2.5 Propiconazole Dietary Exposure Assessment DP Barcode: D329667 PC Code: 122101 Page: 16 of 20 Table 5. Results of Chronic Dietary Exposure Analysis for FOOD and Water Population Subgroup cPAD ( mg/ kg/ day) Exposure ( mg/ kg/ day) % cPAD Females 13 49 years old 0.1 0.002434 2.4 VI. Conclusions These Tier 1 analyses demonstrate that the requested uses for propiconazole will not result in dietary risk estimates that exceed HED's level of concern for any of the regulated population subgroups, including those comprised of infants and children.

A summary of the dietary exposure analyses is given in Table 6. Propiconazole does not possess cancer dietary endpoints; therefore, the results of only the acute and chronic analyses are given in the table.

Table 6. Summary of Dietary Exposure and Risk for Propiconazole FOOD PLUS WATER.

Acute Dietary ( 95th Percentile) Chronic Dietary Cancer Population Subgroup* Dietary Exposure ( mg/ kg/ day) % aPAD Dietary Exposure ( mg/ kg/ day) % cPAD Dietary Exposure ( mg/ kg/ day) Risk General U. S. Population 0.00965 3.2 0.003113 3.1 All Infants (< 1 year old) 0.02352 7.8 0.006597 6.6 Children 1 2 years old 0.01843 6.1 0.007753 7.8 Children 3 5 years old 0.01556 5.2 0.006464 6.5 Children 6 12 years old 0.01074 3.6 0.004314 4.3 Youth 13 19 years old 0.00700 2.3 0.002627 2.6 Adults 20 49 years old 0.00730 2.4 0.002510 2.5 Adults 50+ years old 0.00700 2.3 0.002490 2.5 Females 13 49 years old 0.00725 2.4 0.002434 2.4 N/ A VII. List of Attachments Attachment 1. Acute Food plus Water Residue Input file. Propiconazole Dietary Exposure Assessment DP Barcode: D329667 PC Code: 122101 Page: 17 of 20 Attachment 2. Acute Results file. Attachment 3. Chronic Food plus Water Residue Input file. Attachment 4. Chronic Results file. Propiconazole Dietary Exposure Assessment DP Barcode: D329667 PC Code: 122101 Page: 18 of 20 Attachment 1. Acute Food plus Water Residue Input file.

Filename: C:\ Documents and Settings\ ydonovan\ DEEM Files\ 122101RevisedWaterNumbers\ acute122101RevH2Onumbers. R98 Chemical: Propiconazole RfD( Chronic): .1 mg/ kg bw/ day NOEL( Chronic): 0 mg/ kg bw/ day RfD( Acute): .3 mg/ kg bw/ day NOEL( Acute): 0 mg/ kg bw/ day Date created/ last modified: 06 19 2006/ 12: 51: 15/ 8 Program ver. 2.03 Comment: Acute for general popn  0.3 ( including females now)  EPA Crop Def Res Adj. Factors Comment Code Grp Commodity Name ( ppm) # 1 # 2        12000120 12 Apricot 1.000000 1.000 1.000 12000121 12 Apricot babyfood 1.000000 1.000 1.000 12000130 12 Apricot, dried 1.000000 6.000 1.000 12000140 12 Apricot, juice 1.000000 1.000 1.000 12000141 12 Apricot, juice babyfood 1.000000 1.000 1.000 95000230 O Banana 0.200000 1.000 1.000 95000231 O Banana babyfood 0.200000 1.000 1.000 95000240 O Banana, dried 0.200000 3.900 1.000 95000241 O Banana, dried babyfood 0.200000 3.900 1.000 15000250 15 Barley, pearled barley 0.300000 1.000 1.000 15000251 15 Barley, pearled barley babyfood 0.300000 1.000 1.000 15000260 15 Barley, flour 0.300000 1.000 1.000 15000261 15 Barley, flour babyfood 0.300000 1.000 1.000 15000270 15 Barley, bran 0.300000 1.000 1.000 06030300 6C Bean, black, seed 0.500000 1.000 1.000 Exp 12 Full comment: Exp 12/ 31/ 05 06030320 6C Bean, broad, seed 0.500000 1.000 1.000 Exp 12 Full comment: Exp 12/ 31/ 05 06030340 6C Bean, cowpea, seed 0.500000 1.000 1.000 Exp 12 Full comment: Exp 12/ 31/ 05 06030350 6C Bean, great northern, seed 0.500000 1.000 1.000 Exp 12 Full comment: Exp 12/ 31/ 05 06030360 6C Bean, kidney, seed 0.500000 1.000 1.000 Exp 12 Full comment: Exp 12/ 31/ 05 06030380 6C Bean, lima, seed 0.500000 1.000 1.000 Exp 12 Full comment: Exp 12/ 31/ 05 06030390 6C Bean, mung, seed 0.500000 1.000 1.000 Exp 12 Full comment: Exp 12/ 31/ 05 06030400 6C Bean, navy, seed 0.500000 1.000 1.000 Exp 12 Full comment: Exp 12/ 31/ 05 06030410 6C Bean, pink, seed 0.500000 1.000 1.000 Exp 12 Full comment: Exp 12/ 31/ 05 06030420 6C Bean, pinto, seed 0.500000 1.000 1.000 Exp 12 Full comment: Exp 12/ 31/ 05 21000440 M Beef, meat 0.100000 1.000 1.000 21000441 M Beef, meat babyfood 0.100000 1.000 1.000 21000450 M Beef, meat, dried 0.100000 1.920 1.000 21000460 M Beef, meat byproducts 0.100000 1.000 1.000 21000461 M Beef, meat byproducts babyfood 0.100000 1.000 1.000 21000470 M Beef, fat 0.100000 1.000 1.000 21000471 M Beef, fat babyfood 0.100000 1.000 1.000 21000480 M Beef, kidney 2.000000 1.000 1.000 21000490 M Beef, liver 2.000000 1.000 1.000 21000491 M Beef, liver babyfood 2.000000 1.000 1.000 13020570 13B Blueberry 1.000000 1.000 1.000 13020571 13B Blueberry babyfood 1.000000 1.000 1.000 04020850 4B Celery 5.000000 1.000 1.000 Propiconazole Dietary Exposure Assessment DP Barcode: D329667 PC Code: 122101 Page: 19 of 20 04020851 4B Celery babyfood 5.000000 1.000 1.000 04020860 4B Celery, juice 5.000000 1.000 1.000 12000900 12 Cherry 1.000000 1.000 1.000 12000901 12 Cherry babyfood 1.000000 1.000 1.000 12000910 12 Cherry, juice 1.000000 1.500 1.000 12000911 12 Cherry, juice babyfood 1.000000 1.500 1.000 06030980 6C Chickpea, seed 0.500000 1.000 1.000 Exp 12 Full comment: Exp 12/ 31/ 05 06030981 6C Chickpea, seed babyfood 0.500000 1.000 1.000 Exp 12 Full comment: Exp 12/ 31/ 05 06030990 6C Chickpea, flour 0.500000 1.000 1.000 Exp 12 Full comment: Exp 12/ 31/ 05 15001200 15 Corn, field, flour 0.100000 1.000 1.000 15001201 15 Corn, field, flour babyfood 0.100000 1.000 1.000 15001210 15 Corn, field, meal 0.100000 1.000 1.000 15001211 15 Corn, field, meal babyfood 0.100000 1.000 1.000 15001220 15 Corn, field, bran 0.100000 1.000 1.000 15001230 15 Corn, field, starch 0.100000 1.000 1.000 15001231 15 Corn, field, starch babyfood 0.100000 1.000 1.000 15001240 15 Corn, field, syrup 0.100000 1.500 1.000 15001241 15 Corn, field, syrup babyfood 0.100000 1.500 1.000 15001250 15 Corn, field, oil 0.100000 1.000 1.000 15001251 15 Corn, field, oil babyfood 0.100000 1.000 1.000 15001260 15 Corn, pop 0.100000 1.000 1.000 15001270 15 Corn, sweet 0.100000 1.000 1.000 15001271 15 Corn, sweet babyfood 0.100000 1.000 1.000 95001300 O Cranberry 1.000000 1.000 1.000 Exp 12 Full comment: Exp 12/ 31/ 05 95001301 O Cranberry babyfood 1.000000 1.000 1.000 Exp 12 Full comment: Exp 12/ 31/ 05 95001310 O Cranberry, dried 1.000000 1.000 1.000 Exp 12 Full comment: Exp 12/ 31/ 05 95001320 O Cranberry, juice 1.000000 1.000 1.000 Exp 12 Full comment: Exp 12/ 31/ 05 95001321 O Cranberry, juice babyfood 1.000000 1.000 1.000 Exp 12 Full comment: Exp 12/ 31/ 05 23001690 M Goat, meat 0.100000 1.000 1.000 23001700 M Goat, meat byproducts 0.100000 1.000 1.000 23001710 M Goat, fat 0.100000 1.000 1.000 23001720 M Goat, kidney 2.000000 1.000 1.000 23001730 M Goat, liver 2.000000 1.000 1.000 06031820 6C Guar, seed 0.500000 1.000 1.000 Exp 12 Full comment: Exp 12/ 31/ 05 06031821 6C Guar, seed babyfood 0.500000 1.000 1.000 Exp 12 Full comment: Exp 12/ 31/ 05 24001890 M Horse, meat 0.100000 1.000 1.000 06032030 6C Lentil, seed 0.500000 1.000 1.000 Exp 12 Full comment: Exp 12/ 31/ 05 27002220 D Milk, fat 0.050000 1.000 1.000 27002221 D Milk, fat  baby food/ infant for 0.050000 1.000 1.000 27012230 D Milk, nonfat solids 0.050000 1.000 1.000 27012231 D Milk, nonfat solids baby food/ in 0.050000 1.000 1.000 27022240 D Milk, water 0.050000 1.000 1.000 27022241 D Milk, water babyfood/ infant form 0.050000 1.000 1.000 27032251 D Milk, sugar ( lactose) baby food/ 0.050000 1.000 1.000 95002280 O Mushroom 0.100000 1.000 1.000 12002300 12 Nectarine 1.000000 1.000 1.000 15002310 15 Oat, bran 0.100000 1.000 1.000 15002320 15 Oat, flour 0.100000 1.000 1.000 15002321 15 Oat, flour babyfood 0.100000 1.000 1.000 15002330 15 Oat, groats/ rolled oats 0.100000 1.000 1.000 Propiconazole Dietary Exposure Assessment DP Barcode: D329667 PC Code: 122101 Page: 20 of 20 15002331 15 Oat, groats/ rolled oats babyfood 0.100000 1.000 1.000 12002600 12 Peach 1.000000 1.000 1.000 12002601 12 Peach babyfood 1.000000 1.000 1.000 12002610 12 Peach, dried 1.000000 7.000 1.000 12002611 12 Peach, dried babyfood 1.000000 7.000 1.000 12002620 12 Peach, juice 1.000000 1.000 1.000 12002621 12 Peach, juice babyfood 1.000000 1.000 1.000 95002630 O Peanut 0.200000 1.000 1.000 95002640 O Peanut, butter 0.200000 1.890 1.000 95002650 O Peanut, oil 0.200000 1.000 1.000 14002690 14 Pecan 0.100000 1.000 1.000 95002750 O Peppermint 0.300000 1.000 1.000 95002760 O Peppermint, oil 0.300000 1.000 1.000 95002790 O Pineapple 0.100000 1.000 1.000 95002791 O Pineapple babyfood 0.100000 1.000 1.000 95002800 O Pineapple, dried 0.100000 5.000 1.000 95002810 O Pineapple, juice 0.100000 1.700 1.000 95002811 O Pineapple, juice babyfood 0.100000 1.700 1.000 95002830 O Plantain 0.200000 1.000 1.000 95002840 O Plantain, dried 0.200000 3.900 1.000 12002850 12 Plum 1.000000 1.000 1.000 12002851 12 Plum babyfood 1.000000 1.000 1.000 12002860 12 Plum, prune, fresh 1.000000 1.000 1.000 12002861 12 Plum, prune, fresh babyfood 1.000000 1.000 1.000 12002870 12 Plum, prune, dried 1.000000 5.000 1.000 12002871 12 Plum, prune, dried babyfood 1.000000 5.000 1.000 12002880 12 Plum, prune, juice 1.000000 1.400 1.000 12002881 12 Plum, prune, juice babyfood 1.000000 1.400 1.000 25002900 M Pork, meat 0.100000 1.000 1.000 25002901 M Pork, meat babyfood 0.100000 1.000 1.000 25002910 M Pork, skin 0.100000 1.000 1.000 25002920 M Pork, meat byproducts 0.100000 1.000 1.000 25002921 M Pork, meat byproducts babyfood 0.100000 1.000 1.000 25002930 M Pork, fat 0.100000 1.000 1.000 25002931 M Pork, fat babyfood 0.100000 1.000 1.000 25002940 M Pork, kidney 2.000000 1.000 1.000 25002950 M Pork, liver 2.000000 1.000 1.000 15003230 15 Rice, white 0.300000 1.000 1.000 15003231 15 Rice, white babyfood 0.300000 1.000 1.000 15003240 15 Rice, brown 0.300000 1.000 1.000 15003241 15 Rice, brown babyfood 0.300000 1.000 1.000 15003250 15 Rice, flour 0.300000 1.000 1.000 15003251 15 Rice, flour babyfood 0.300000 1.000 1.000 15003260 15 Rice, bran 1.000000 1.000 1.000 New To Full comment: New Tolerance/ Rice Processing Study 15003261 15 Rice, bran babyfood 1.000000 1.000 1.000 New To Full comment: New Tolerance/ Rice Processing Study 15003280 15 Rye, grain 0.300000 1.000 1.000 15003290 15 Rye, flour 0.300000 1.000 1.000 26003390 M Sheep, meat 0.100000 1.000 1.000 26003391 M Sheep, meat babyfood 0.100000 1.000 1.000 26003400 M Sheep, meat byproducts 0.100000 1.000 1.000 26003410 M Sheep, fat 0.100000 1.000 1.000 26003411 M Sheep, fat babyfood 0.100000 1.000 1.000 26003420 M Sheep, kidney 2.000000 1.000 1.000 26003430 M Sheep, liver 2.000000 1.000 1.000 15003440 15 Sorghum, grain 0.200000 1.000 1.000 Exp 6/ Full comment: Exp 6/ 30/ 05 15003450 15 Sorghum, syrup 0.200000 1.000 1.000 Exp 6/ Full comment: Exp 6/ 30/ 05 06003470 6 Soybean, seed 0.500000 1.000 1.000 Propiconazole Dietary Exposure Assessment DP Barcode: D329667 PC Code: 122101 Page: 21 of 20 06003480 6 Soybean, flour 0.500000 1.000 1.000 06003481 6 Soybean, flour babyfood 0.500000 1.000 1.000 06003490 6 Soybean, soy milk 0.500000 1.000 1.000 06003491 6 Soybean, soy milk babyfood or in 0.500000 1.000 1.000 06003500 6 Soybean, oil 0.500000 1.000 1.000 06003501 6 Soybean, oil babyfood 0.500000 1.000 1.000 95003520 O Spearmint 0.300000 1.000 1.000 95003530 O Spearmint, oil 0.300000 1.000 1.000 86010000 O Water, direct, all sources 0.086400 1.000 1.000 Per Ja Full comment: Per James Lin email of 6/ 6/ 06 86020000 O Water, indirect, all sources 0.086400 1.000 1.000 Per Ja Full comment: Per James Lin email of 6/ 6/ 06 15004010 15 Wheat, grain 0.300000 1.000 1.000 15004011 15 Wheat, grain babyfood 0.300000 1.000 1.000 15004020 15 Wheat, flour 0.300000 1.000 1.000 15004021 15 Wheat, flour babyfood 0.300000 1.000 1.000 15004030 15 Wheat, germ 0.300000 1.000 1.000 15004040 15 Wheat, bran 1.000000 1.000 1.000 15004050 15 Wild rice 0.500000 1.000 1.000 Propiconazole Dietary Exposure Assessment DP Barcode: D329667 PC Code: 122101 Page: 22 of 20 Attachment 2. Acute Results file.

U. S. Environmental Protection Agency Ver. 2.02 DEEM FCID ACUTE Analysis for PROPICONAZOLE ( 1994 98 data) Residue file: acute122101RevH2Onumbers. R98 Adjustment factor # 2 NOT used. Analysis Date: 06 19 2006/ 11: 50: 19 Residue file dated: 06 19 2006/ 11: 39: 20/ 8 Daily totals for food and foodform consumption used. Run Comment: " Acute for general popn  0.3 ( including females now)" ===============================================================================

Summary calculations ( per capita):

95th Percentile 99th Percentile 99.9th Percentile Exposure % aRfD Exposure % aRfD Exposure % aRfD       U. S. Population: 0.009652 3.22 0.015946 5.32 0.027984 9.33 Hispanics: 0.011998 4.00 0.019577 6.53 0.033612 11.20 Non hispanic whites: 0.009094 3.03 0.014873 4.96 0.025933 8.64 Non hispanic blacks: 0.010270 3.42 0.016660 5.55 0.030254 10.08 Non hisp/ non white/ non black: 0.011084 3.69 0.017377 5.79 0.045799 15.27 All infants: 0.023517 7.84 0.031089 10.36 0.046934 15.64 Nursing infants (< 1 yr old): 0.016513 5.50 0.027602 9.20 0.034885 11.63 Females 13+ ( preg/ not nursing): 0.007523 2.51 0.010287 3.43 0.011465 3.82 Females 13+ ( nursing): 0.008392 2.80 0.010126 3.38 0.010737 3.58 Children 1 2 yrs: 0.018429 6.14 0.029355 9.79 0.059078 19.69 Children 3 5 yrs: 0.015561 5.19 0.022094 7.36 0.035971 11.99 Children 6 12 yrs: 0.010740 3.58 0.016779 5.59 0.026908 8.97 Youth 13 19 yrs: 0.007004 2.33 0.011073 3.69 0.017934 5.98 Adults 20 49 yrs: 0.007303 2.43 0.010901 3.63 0.017921 5.97 Adults 50+ yrs: 0.007000 2.33 0.010294 3.43 0.016047 5.35 Females 13 49 yrs: 0.007250 2.42 0.010761 3.59 0.015968 5.32 Propiconazole Dietary Exposure Assessment DP Barcode: D329667 PC Code: 122101 Page: 23 of 20 Attachment 3. Chronic Food plus Water Residue Input file.

Filename: C:\ Documents and Settings\ ydonovan\ DEEM Files\ 122101RevisedWaterNumbers\ chronic122101RevH2Onumbers. R98 Chemical: Propiconazole RfD( Chronic): .1 mg/ kg bw/ day NOEL( Chronic): 0 mg/ kg bw/ day RfD( Acute): .3 mg/ kg bw/ day NOEL( Acute): 0 mg/ kg bw/ day Date created/ last modified: 06 19 2006/ 13: 49: 04/ 8 Program ver. 2.03  EPA Crop Def Res Adj. Factors Comment Code Grp Commodity Name ( ppm) # 1 # 2        12000120 12 Apricot 1.000000 1.000 1.000 12000121 12 Apricot babyfood 1.000000 1.000 1.000 12000130 12 Apricot, dried 1.000000 6.000 1.000 12000140 12 Apricot, juice 1.000000 1.000 1.000 12000141 12 Apricot, juice babyfood 1.000000 1.000 1.000 95000230 O Banana 0.200000 1.000 1.000 95000231 O Banana babyfood 0.200000 1.000 1.000 95000240 O Banana, dried 0.200000 3.900 1.000 95000241 O Banana, dried babyfood 0.200000 3.900 1.000 15000250 15 Barley, pearled barley 0.300000 1.000 1.000 15000251 15 Barley, pearled barley babyfood 0.300000 1.000 1.000 15000260 15 Barley, flour 0.300000 1.000 1.000 15000261 15 Barley, flour babyfood 0.300000 1.000 1.000 15000270 15 Barley, bran 0.300000 1.000 1.000 06030300 6C Bean, black, seed 0.500000 1.000 1.000 Exp 12 Full comment: Exp 12/ 31/ 05 06030320 6C Bean, broad, seed 0.500000 1.000 1.000 Exp 12 Full comment: Exp 12/ 31/ 05 06030340 6C Bean, cowpea, seed 0.500000 1.000 1.000 Exp 12 Full comment: Exp 12/ 31/ 05 06030350 6C Bean, great northern, seed 0.500000 1.000 1.000 Exp 12 Full comment: Exp 12/ 31/ 05 06030360 6C Bean, kidney, seed 0.500000 1.000 1.000 Exp 12 Full comment: Exp 12/ 31/ 05 06030380 6C Bean, lima, seed 0.500000 1.000 1.000 Exp 12 Full comment: Exp 12/ 31/ 05 06030390 6C Bean, mung, seed 0.500000 1.000 1.000 Exp 12 Full comment: Exp 12/ 31/ 05 06030400 6C Bean, navy, seed 0.500000 1.000 1.000 Exp 12 Full comment: Exp 12/ 31/ 05 06030410 6C Bean, pink, seed 0.500000 1.000 1.000 Exp 12 Full comment: Exp 12/ 31/ 05 06030420 6C Bean, pinto, seed 0.500000 1.000 1.000 Exp 12 Full comment: Exp 12/ 31/ 05 21000440 M Beef, meat 0.100000 1.000 1.000 21000441 M Beef, meat babyfood 0.100000 1.000 1.000 21000450 M Beef, meat, dried 0.100000 1.920 1.000 21000460 M Beef, meat byproducts 0.100000 1.000 1.000 21000461 M Beef, meat byproducts babyfood 0.100000 1.000 1.000 21000470 M Beef, fat 0.100000 1.000 1.000 21000471 M Beef, fat babyfood 0.100000 1.000 1.000 21000480 M Beef, kidney 2.000000 1.000 1.000 21000490 M Beef, liver 2.000000 1.000 1.000 21000491 M Beef, liver babyfood 2.000000 1.000 1.000 13020570 13B Blueberry 1.000000 1.000 1.000 13020571 13B Blueberry babyfood 1.000000 1.000 1.000 Propiconazole Dietary Exposure Assessment DP Barcode: D329667 PC Code: 122101 Page: 24 of 20 04020850 4B Celery 5.000000 1.000 1.000 04020851 4B Celery babyfood 5.000000 1.000 1.000 04020860 4B Celery, juice 5.000000 1.000 1.000 12000900 12 Cherry 1.000000 1.000 1.000 12000901 12 Cherry babyfood 1.000000 1.000 1.000 12000910 12 Cherry, juice 1.000000 1.500 1.000 12000911 12 Cherry, juice babyfood 1.000000 1.500 1.000 06030980 6C Chickpea, seed 0.500000 1.000 1.000 Exp 12 Full comment: Exp 12/ 31/ 05 06030981 6C Chickpea, seed babyfood 0.500000 1.000 1.000 Exp 12 Full comment: Exp 12/ 31/ 05 06030990 6C Chickpea, flour 0.500000 1.000 1.000 Exp 12 Full comment: Exp 12/ 31/ 05 15001200 15 Corn, field, flour 0.100000 1.000 1.000 15001201 15 Corn, field, flour babyfood 0.100000 1.000 1.000 15001210 15 Corn, field, meal 0.100000 1.000 1.000 15001211 15 Corn, field, meal babyfood 0.100000 1.000 1.000 15001220 15 Corn, field, bran 0.100000 1.000 1.000 15001230 15 Corn, field, starch 0.100000 1.000 1.000 15001231 15 Corn, field, starch babyfood 0.100000 1.000 1.000 15001240 15 Corn, field, syrup 0.100000 1.500 1.000 15001241 15 Corn, field, syrup babyfood 0.100000 1.500 1.000 15001250 15 Corn, field, oil 0.100000 1.000 1.000 15001251 15 Corn, field, oil babyfood 0.100000 1.000 1.000 15001260 15 Corn, pop 0.100000 1.000 1.000 15001270 15 Corn, sweet 0.100000 1.000 1.000 15001271 15 Corn, sweet babyfood 0.100000 1.000 1.000 95001300 O Cranberry 1.000000 1.000 1.000 Exp 12 Full comment: Exp 12/ 31/ 05 95001301 O Cranberry babyfood 1.000000 1.000 1.000 Exp 12 Full comment: Exp 12/ 31/ 05 95001310 O Cranberry, dried 1.000000 1.000 1.000 Exp 12 Full comment: Exp 12/ 31/ 05 95001320 O Cranberry, juice 1.000000 1.000 1.000 Exp 12 Full comment: Exp 12/ 31/ 05 95001321 O Cranberry, juice babyfood 1.000000 1.000 1.000 Exp 12 Full comment: Exp 12/ 31/ 05 23001690 M Goat, meat 0.100000 1.000 1.000 23001700 M Goat, meat byproducts 0.100000 1.000 1.000 23001710 M Goat, fat 0.100000 1.000 1.000 23001720 M Goat, kidney 2.000000 1.000 1.000 23001730 M Goat, liver 2.000000 1.000 1.000 06031820 6C Guar, seed 0.500000 1.000 1.000 Exp 12 Full comment: Exp 12/ 31/ 05 06031821 6C Guar, seed babyfood 0.500000 1.000 1.000 Exp 12 Full comment: Exp 12/ 31/ 05 24001890 M Horse, meat 0.100000 1.000 1.000 06032030 6C Lentil, seed 0.500000 1.000 1.000 Exp 12 Full comment: Exp 12/ 31/ 05 27002220 D Milk, fat 0.050000 1.000 1.000 27002221 D Milk, fat  baby food/ infant for 0.050000 1.000 1.000 27012230 D Milk, nonfat solids 0.050000 1.000 1.000 27012231 D Milk, nonfat solids baby food/ in 0.050000 1.000 1.000 27022240 D Milk, water 0.050000 1.000 1.000 27022241 D Milk, water babyfood/ infant form 0.050000 1.000 1.000 27032251 D Milk, sugar ( lactose) baby food/ 0.050000 1.000 1.000 95002280 O Mushroom 0.100000 1.000 1.000 12002300 12 Nectarine 1.000000 1.000 1.000 15002310 15 Oat, bran 0.100000 1.000 1.000 15002320 15 Oat, flour 0.100000 1.000 1.000 15002321 15 Oat, flour babyfood 0.100000 1.000 1.000 Propiconazole Dietary Exposure Assessment DP Barcode: D329667 PC Code: 122101 Page: 25 of 20 15002330 15 Oat, groats/ rolled oats 0.100000 1.000 1.000 15002331 15 Oat, groats/ rolled oats babyfood 0.100000 1.000 1.000 12002600 12 Peach 1.000000 1.000 1.000 12002601 12 Peach babyfood 1.000000 1.000 1.000 12002610 12 Peach, dried 1.000000 7.000 1.000 12002611 12 Peach, dried babyfood 1.000000 7.000 1.000 12002620 12 Peach, juice 1.000000 1.000 1.000 12002621 12 Peach, juice babyfood 1.000000 1.000 1.000 95002630 O Peanut 0.200000 1.000 1.000 95002640 O Peanut, butter 0.200000 1.890 1.000 95002650 O Peanut, oil 0.200000 1.000 1.000 14002690 14 Pecan 0.100000 1.000 1.000 95002750 O Peppermint 0.300000 1.000 1.000 95002760 O Peppermint, oil 0.300000 1.000 1.000 95002790 O Pineapple 0.100000 1.000 1.000 95002791 O Pineapple babyfood 0.100000 1.000 1.000 95002800 O Pineapple, dried 0.100000 5.000 1.000 95002810 O Pineapple, juice 0.100000 1.700 1.000 95002811 O Pineapple, juice babyfood 0.100000 1.700 1.000 95002830 O Plantain 0.200000 1.000 1.000 95002840 O Plantain, dried 0.200000 3.900 1.000 12002850 12 Plum 1.000000 1.000 1.000 12002851 12 Plum babyfood 1.000000 1.000 1.000 12002860 12 Plum, prune, fresh 1.000000 1.000 1.000 12002861 12 Plum, prune, fresh babyfood 1.000000 1.000 1.000 12002870 12 Plum, prune, dried 1.000000 5.000 1.000 12002871 12 Plum, prune, dried babyfood 1.000000 5.000 1.000 12002880 12 Plum, prune, juice 1.000000 1.400 1.000 12002881 12 Plum, prune, juice babyfood 1.000000 1.400 1.000 25002900 M Pork, meat 0.100000 1.000 1.000 25002901 M Pork, meat babyfood 0.100000 1.000 1.000 25002910 M Pork, skin 0.100000 1.000 1.000 25002920 M Pork, meat byproducts 0.100000 1.000 1.000 25002921 M Pork, meat byproducts babyfood 0.100000 1.000 1.000 25002930 M Pork, fat 0.100000 1.000 1.000 25002931 M Pork, fat babyfood 0.100000 1.000 1.000 25002940 M Pork, kidney 2.000000 1.000 1.000 25002950 M Pork, liver 2.000000 1.000 1.000 15003230 15 Rice, white 0.300000 1.000 1.000 15003231 15 Rice, white babyfood 0.300000 1.000 1.000 15003240 15 Rice, brown 0.300000 1.000 1.000 15003241 15 Rice, brown babyfood 0.300000 1.000 1.000 15003250 15 Rice, flour 0.300000 1.000 1.000 15003251 15 Rice, flour babyfood 0.300000 1.000 1.000 15003260 15 Rice, bran 1.000000 1.000 1.000 New To Full comment: New Tolerance/ Rice Processing Study 15003261 15 Rice, bran babyfood 1.000000 1.000 1.000 New To Full comment: New Tolerance/ Rice Processing Study 15003280 15 Rye, grain 0.300000 1.000 1.000 15003290 15 Rye, flour 0.300000 1.000 1.000 26003390 M Sheep, meat 0.100000 1.000 1.000 26003391 M Sheep, meat babyfood 0.100000 1.000 1.000 26003400 M Sheep, meat byproducts 0.100000 1.000 1.000 26003410 M Sheep, fat 0.100000 1.000 1.000 26003411 M Sheep, fat babyfood 0.100000 1.000 1.000 26003420 M Sheep, kidney 2.000000 1.000 1.000 26003430 M Sheep, liver 2.000000 1.000 1.000 15003440 15 Sorghum, grain 0.200000 1.000 1.000 Exp 6/ Full comment: Exp 6/ 30/ 05 15003450 15 Sorghum, syrup 0.200000 1.000 1.000 Exp 6/ Full comment: Exp 6/ 30/ 05 Propiconazole Dietary Exposure Assessment DP Barcode: D329667 PC Code: 122101 Page: 26 of 20 06003470 6 Soybean, seed 0.500000 1.000 1.000 06003480 6 Soybean, flour 0.500000 1.000 1.000 06003481 6 Soybean, flour babyfood 0.500000 1.000 1.000 06003490 6 Soybean, soy milk 0.500000 1.000 1.000 06003491 6 Soybean, soy milk babyfood or in 0.500000 1.000 1.000 06003500 6 Soybean, oil 0.500000 1.000 1.000 06003501 6 Soybean, oil babyfood 0.500000 1.000 1.000 95003520 O Spearmint 0.300000 1.000 1.000 95003530 O Spearmint, oil 0.300000 1.000 1.000 86010000 O Water, direct, all sources 0.037520 1.000 1.000 Per Ja Full comment: Per James Lin email 6/ 6/ 06 Turf in PA 86020000 O Water, indirect, all sources 0.037520 1.000 1.000 Per Ja Full comment: Per James Lin email 6/ 6/ 06 Turf in PA 15004010 15 Wheat, grain 0.300000 1.000 1.000 15004011 15 Wheat, grain babyfood 0.300000 1.000 1.000 15004020 15 Wheat, flour 0.300000 1.000 1.000 15004021 15 Wheat, flour babyfood 0.300000 1.000 1.000 15004030 15 Wheat, germ 0.300000 1.000 1.000 15004040 15 Wheat, bran 1.000000 1.000 1.000 15004050 15 Wild rice 0.500000 1.000 1.000 Propiconazole Dietary Exposure Assessment DP Barcode: D329667 PC Code: 122101 Page: 27 of 20 Attachment 4. Chronic Results file.

U. S. Environmental Protection Agency Ver. 2.00 DEEM FCID Chronic analysis for PROPICONAZOLE ( 1994 98 data) Residue file name: C:\ Documents and Settings\ ydonovan\ DEEM Files\ 122101RevisedWaterNumbers\ chronic122101RevH2Onumbers. R98 Adjustment factor # 2 NOT used. Analysis Date 06 19 2006/ 13: 52: 27 Residue file dated: 06 19 2006/ 13: 49: 04/ 8 Reference dose ( RfD, Chronic) = .1 mg/ kg bw/ day NOEL ( Chronic) = 10 mg/ kg bw/ day =============================================================================== Total exposure by population subgroup

Total Exposure  Population mg/ kg Margin of Percent Subgroup body wt/ day Exposure 1/ of RfD     U. S. Population ( total) 0.003113 3,212 3.1%

U. S. Population ( spring season) 0.003106 3,220 3.1% U. S. Population ( summer season) 0.003241 3,085 3.2% U. S. Population ( autumn season) 0.003047 3,282 3.0% U. S. Population ( winter season) 0.003058 3,270 3.1%

Northeast region 0.003091 3,235 3.1% Midwest region 0.003205 3,121 3.2% Southern region 0.002855 3,502 2.9% Western region 0.003444 2,904 3.4%

Hispanics 0.003550 2,817 3.5% Non hispanic whites 0.003048 3,280 3.0% Non hispanic blacks 0.002891 3,459 2.9% Non hisp/ non white/ non black 0.003766 2,655 3.8%

All infants (< 1 year) 0.006597 1,516 6.6% Nursing infants 0.002927 3,417 2.9% Non nursing infants 0.007990 1,252 8.0% Children 1 6 yrs 0.006751 1,481 6.8% Children 7 12 yrs 0.004082 2,450 4.1%

Females 13 19 ( not preg or nursing) 0.002394 4,178 2.4% Females 20+ ( not preg or nursing) 0.002442 4,095 2.4% Females 13 50 yrs 0.002615 3,825 2.6% Females 13+ ( preg/ not nursing) 0.002854 3,504 2.9% Females 13+ ( nursing) 0.003111 3,215 3.1%

Males 13 19 yrs 0.002845 3,515 2.8% Males 20+ yrs 0.002553 3,917 2.6% Seniors 55+ 0.002503 3,994 2.5%

Children 1 2 yrs 0.007753 1,290 7.8% Children 3 5 yrs 0.006464 1,547 6.5% Children 6 12 yrs 0.004314 2,318 4.3% Youth 13 19 yrs 0.002627 3,807 2.6% Adults 20 49 yrs 0.002510 3,983 2.5% Adults 50+ yrs 0.002490 4,016 2.5% Propiconazole Dietary Exposure Assessment DP Barcode: D329667 PC Code: 122101 Page: 28 of 20 Females 13 49 yrs 0.002434 4,108 2.4%


[Federal Register Volume 77, Number 52 (Friday, March 16, 2012)]
[Notices]
[Pages 15822-15824]
[FR Doc No: 2012-6384]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-66574; File No. SR-FICC-2012-02]

Self-Regulatory Organizations; Fixed Income Clearing Corporation;
Notice of Filing of Proposed Rule Change To Remove Functionality in the
Government Securities Division's Rules That Is No Longer Utilized by
Participants

March 12, 2012.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'') \1\ and Rule 19b-4 thereunder \2\ notice is hereby given that
on February 29, 2012, the Fixed Income Clearing Corporation (``FICC'')
filed with the Securities and Exchange Commission (``Commission'') the
proposed change as

described in Items I and II below, which Items have been prepared
primarily by FICC. The Commission is publishing this notice to solicit
comments on the proposed change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The proposed rule change consists of modifications to certain rules
of the Government Securities Division (``GSD'') of the Fixed Income
Clearing Corporation (``FICC'') that refer to functions or
classifications that are either technologically obsolete or no longer
used by participants.

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, FICC included statements
concerning the purpose of and basis for the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. FICC has prepared summaries, set forth in sections (A),
(B), and (C) below, of the most significant aspects of these
statements.\3\
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    \3\ The Commission has modified the text of the summaries
prepared by FICC.
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(A) Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    The purpose of this filing is to revise the GSD rules to eliminate
references to functions or classifications that are either
technologically obsolete or no longer utilized by GSD's participants.
Reflected below are descriptions of the proposed changes to the rules.
1. ``Non-Conversion Participants''/``Conversion Participants''
    When first implemented, the DVP System required all participants
that submitted when issued trades to resubmit those trades with final
money calculations on the night of Auction Date, after the Treasury
Auction results were announced. Subsequent to the initial
implementation, enhancements were incorporated such that the DVP System
recalculated trades (repriced) based on auction results. FICC also
incorporated an option whereby participants could decide if they wanted
to resubmit their trades (participants who elected this option were
known as ``Non-Conversion Participants'') or take FICC's repricing
notification (participants who elected this option were known as
``Conversion Participants''). With the implementation of Interactive
Messaging in 2000, the few remaining Non-Conversion Participants agreed
to take FICC's calculations, rather than resubmit their trades to FICC.
As such, FICC proposes to remove references in the rules to Non-
Conversion Participants. Given that all participants who submit when-
issued transactions for matching/netting are subject to accepting
FICC's calculations for their trades based on Treasury Auction Results,
the proposed rule changes replace references to ``Conversion
Participants'' with ``Participants.''
2. Auction Priority Delivery Requests and Customer Delivery Requests
(CDRs)
    Auction Priority Delivery Requests, also known as Customer Delivery
Requests (CDRs), were originally built for FICC's batch file transfer,
which was the initial proprietary method that participants used to
submit trade activity to FICC. This functionality allowed the dealer to
instruct FICC to withhold certain auction trades from the net to ensure
that a priority client received their auction allotment so the trade
could not be netted out during FICC's end of day netting process.
However, when Interactive Messaging was implemented in 2000, this
instruction type was not supported as it was no longer used. As a
result, FICC proposes to remove references in the rules to Auction
Priority Delivery Requests and Customer Delivery Requests (CDRs).
3. Repo Substitution Criteria
    GSD initially provided optional fields for Repo Substitution
Criteria for trade submissions. However, over the years, participants
generally have not used these fields. Because the fields were provided
as an informational courtesy that has not been used by participants,
the new system will not contain them. From a rules perspective this
entails the deletion of references to those fields in related schedule.
    In addition to the above-referenced changes which relate to the DVP
System, FICC proposes to make the following additional technical
corrections to the GSD rules:

--Terminal interfaces and video display terminals are currently
referenced in the rules. The terminals became obsolete when FICC
replaced them with a web browser interface. Because the terminals are
no longer in existence, FICC proposes to remove references to these
methods from the GSD rules.
--Currently, the ``Schedule of Required and Other Data Submission Items
from GCF Repo Transactions'' refers to ``Reverse dealer Exec. Id'' and
a ``Repo dealer Exec Id.'' When FICC began using the GSD RTTM web
format, these fields were eliminated because they did not have any
significance for GCF repo trades. As a result, FICC proposes to remove
these references from the rules.

FICC believes the proposed change is consistent with Section 17A of the
Act and the rules and regulations thereunder because it facilitates the
prompt and accurate clearance and settlement of securities by ensuring
that FICC's rules are accurate.

(B) Self-Regulatory Organization's Statement on Burden on Competition

    FICC does not believe that the proposed rule change would impose
any burden on competition.

(C) Self-Regulatory Organization's Statement on Comments on the
Proposed Rule Change Received From Members, Participants or Others

    Written comments relating to the proposed rule change have not yet
been solicited or received. FICC will notify the Commission of any
written comments received by FICC.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    Within 45 days of the date of publication of this notice in the
Federal Register or within such longer period up to 90 days (i) as the
Commission may designate if it finds such longer period to be
appropriate and publishes its reasons for so finding or (ii) as to
which the self-regulatory organization consents, the Commission will:
    (A) by order approve or disapprove the proposed rule change; or
    (B) institute proceedings to determine whether the proposed rule
change should be disapproved.

Electronic Comments

     Use the Commissions Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-FICC-2012-02 on the subject line.

Paper Comments

     Send paper comments in triplicate to Elizabeth M. Murphy,
Secretary, Securities and Exchange Commission, 100 F Street NE.,
Washington, DC 20549-1090.

All submissions should refer to File Number SR-FICC-2012-02. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Section, 100 F Street
NE., Washington, DC 20549, on official business days between the hours
of 10 a.m. and 3 p.m. Copies of such filing also will be available for
inspection and copying at the principal office of FICC and on FICC's
Web site at http://www.dtcc.com/downloads/legal/rule_filings/2012/ficc/SR_FICC_2012_02.pdf.
    All comments received will be posted without change; the Commission
does not edit personal identifying information from submissions. You
should submit only information that you wish to make available
publicly. All submissions should refer to File Number SR-FICC-2012-02
and should be submitted on or before April 6, 2012.
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    \4\ 17 CFR 200.30-3(a)(12).

    For the Commission by the Division of Trading and Markets,
pursuant to delegated authority.\4\
Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2012-6384 Filed 3-15-12; 8:45 am]
BILLING CODE 8011-01-P