Amicarbazone Dietary Exposure and Risk Assessment PC Code: 114004 DP Number: D 394925

Page 1 of 12 **UNITED STATES ENVIRONMENTAL PROTECTION AGENCY**

**WASHINGTON, D.C. 20460 OFFICE OF**  **CHEMICAL SAFETY AND POLLUTION**  **PREVENTION MEMORANDUM**  **Date: 10**  **/ 5**  **/201 1**  **SUBJECT: Am**  **icarbazone** Acute and Chronic Aggregate Dietary (Food and Drinking Water) Exposure and Risk Assessments for the Section 3 Registration Action on Turfgrass **PC Code:** 114004 **DP Barcode:** D 394925 **Decision No.:** 441345 **Registration No. :**  66330 - 4 6 **Petitions:** NA **Regulatory Action:** Section 3 Registration **Risk Assessment Type:** Dietary **Case No.:** NA **T XR No.:**  NA **CAS No.:** 1 29909 - 90 - 6 **MRID No.:** NA **40 CFR:** 180.615 **FROM:** Douglas Dotson, Ph.D., Chemist

Risk Assessment Branch II Health Effects Division (7509P) **THROUGH:** William Cutchin , Chemist

Thurston Morton, Chemist Dietary Exposure Science Advisory Council (DESAC) **TO:** Michael Walsh/ Kathry n Montague , RM Team 23 Herb icide Branch Registration Division (7505P) **Executive Summary** Acute and chronic aggregate dietary (food and drinking water) exposure and risk assessments were conducted using the Dietary Exposure Evaluation Model DEEM - FCIDTM, Version 2.03 which use s food consumption data from the U.S. Department of Agriculture’s (USDA’s) Continuing Survey s of Food Intakes by I ndividuals (CSFII) from 1994 - 1996 and 1998 . The anal ys es were conducted as part of a human health risk assessment for the requested use of the herbicide amicarbazone on turfgrass and conifers .Amicarbazone Dietary Exposure and Risk Assessment PC Code: 114004 DP Number: D 394925

Page 2 of 12 T he acute and chronic analy s es are both based on conservative estimates of residues in food and drinking water. For amicarbazone, drinking water is the greatest contributor to dietary exposure and risk. T he estimated drinking water concentrations (EDWCs) represent upper - bound estimates that might be found in surface water and groundwater as a result of the application of amicarbazone on turf and conifers one time at the maximum yearly rate (worst case scenario). In addition, tolerance - level residues and 100% crop treated assumptions were made for all food commodities . DEEM default processing factors were used for processed commodities for which they were available . Because such conservative assumptions were made in the assessments, the resulting exposur e and risk estimates are considered to be conservative as well . HED is confident that the acute and chronic dietary exposure assessments do not underestimate risk to the general U.S. population or an y population subgroup. The acute risk estimates are bel ow HED’s level of concern for all population subgroups, including those comprised of infants and children. Generally , HED is concerned when risk estimates exceed 100% of the population - adjusted dose (PAD). The acute risk estimate for the general U.S. pop ulation is 8.8 % of the acute PAD (aPAD). The population subgroup with the highest acute dietary

risk estimate is All Infants , which uses 29 % of the aPAD. As percent crop treated estimates and monitoring data were not incorporated into the acute assessment, the risk estimates are being reported at the 95 th percentile of exposure. C hronic risk estimates are below HED’s level of concern for all population subgroups. The risk estimate for the general U.S. population is 1 7 % of the chronic PAD (cPAD) . The most high ly exposed population subgroup is A ll Infant s (<1 ye ar old), which uses 48 % of the cPAD . Amicarbazone has been classified as “ not likel y t o be a human carcinogen . ” As a result, a dietary exposure assessment for cancer risk is not necessary . **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 resul t in no unreasonable adverse health effects). This dose i s referred to as the population - adjusted dose (PAD). The PAD is equivalent to the point of departure (POD, NOAEL, LOAEL, e.g.) divided by the required uncertaint y or safet y factors. For acute and non - cancer chronic exposures, HED is concerned when estimated dietary risk exceeds 100% of the PAD. References which discuss the acute and chronic risk assessments in more detail are available on the EPA/pesticides web site: “Available Information on Ass essing Exposure from Pesticides, A User’s Guide,” 21 J un 2000, web link: http://www.epa.gov/fedrgstr/EPA - PEST/2000/July /Day - 12/6061.pdf

; or see SOP 99.6 (20 Aug 1999). The last dietary

exposure assessment p erformed for amicarbazone was done in 2005, when tolerances were first established for the chemical (D313754, D. Dotson, 4/19/2005) .Amicarbazone Dietary Exposure and Risk Assessment PC Code: 114004 DP Number: D 394925

Page 3 of 12 **II. Residue Information**  This registration action is being performed for the proposed use o n turfgrass. No tolerances are being proposed at the present time. E stablished t olerances are for the combined residues of amicarbazone and its metabolites DA amicarbazone and isoprop yl - 2 - OH - DA amicarbazone. For risk assessment purposes, additional meta bolites are included with the three residues to be used for tolerance enforcement. For assessing human dietary exposure to residues in wheat grain (or any other rotated cereal grains), the two glucose conjugates of DA OH MKH 3586 are included. These conj ugates constituted about 30% of the grain TRR at the 138 - and 364 - day plant back intervals. In ruminants, the metabolite tBuOH MKH 3586 is included because of the fact that it was the highest level residue in milk (28% TRR) as well as a major metabolite ( > 10% TRR) in muscle and kidney . For poultry commodities, the metabolites iPr - Acid DA MKH 3586, iPr - 1 - OH DA MKH 3586, and iPr - Ene DA MKH 3586 are included in the risk assessment because of their presence as major residues in liver, fat, or eggs. These ad ditional metabolites all contain the triazolinone ring and, therefore, are considered toxicologically equivalent to the parent. In order to account for these metabolites in the dietary exposure anal ys es, the tolerances were multiplied by

factors that acco unt for their contribution to the exposure. These factors are given in Table 1 along with the recommended tolerances. **Table 1. Residue Values for Use in Dietary Exposure Assessment** 

**Commodity Tolerance**  **(ppm) Metabolite** 

**Factor Residue**  **Value Used in Dietary** 

**Exposure Assessment**  **s** Field Corn Grain 0.05 - 0.05 Undelinted Cotton Seed 0.07 - 0.07 Soy bean Seed 0.8 - 0.8 Wheat Grain 0.1 1.7 0.17 Wheat Milled Byproducts 0.15 1.7 0.255 Milk 0.01 1.6 0.016 Meat of cattle, goats, hogs, horses, and sheep 0.01 1.2 0.012 Fat of cattle, goats, hogs, horses, and sheep 0.01 - 0.01 Liver of cattle, goats, horses, sheep 1.0 - 1.0 Meat Byproducts (except liver) of cattle, goats, horses, and sheep 0.1 1.2 0.12 Hog liver 0.1 - 0.1 Meat Byproducts (except liver) of hogs 0.01 1.2 0.012 Poultry liver 0.01 1.8 0.018Amicarbazone Dietary Exposure and Risk Assessment PC Code: 114004 DP Number: D 394925

Page 4 of 12 **III .**  **Percent Crop Treated Information** The acute and chronic assessments were both based on the assumption that 100% of all commodities with amicarbazone tolerances will be treated. **IV. Drinking Water Data**  The estimated drinking water concentrations (EDWCs) used in the dietary risk assessment s w ere provided b y the Environmental Fate and Effects Division (EFED ; D 3 84659 , A. Shelby , 9 / 7 / 20 1 1 ) . The EDWCs are incorporated directl y into this dietary assessment into the food categories “water, direct, all sources” and “water, indirect, all sources.” The residues of concern in drinking water for risk assessment are parent amicarbazone and its des - amino and N - methy l des - amino degradates . The surface water and groundwater estimates we re calculated using the PRZM/EXAMS and SCI - GROW Models , respectively . The EDWCs given in Table 2 are the total toxic residues of amicarbazone , which include the des - amino and N - methy l des - amino degradates as well as unextracted residues. The EDWCs represent upper - bound estimates that might be found in surface water and groundwater as a result of the application of amicarbazone on turf and conifers one time at the maxi mum yearly rate (worst case scenario). The groundwater estimate of 136 ppb was used for both the acute and chronic assessments because it was higher than all of the surface water values. For more information about EFED’s drinking water models, see http://www.epa.gov/oppefed1/models/water/ ).
**Table 2. A micarbazone EDWCs Determined Using the PRZM/EXAMS**  **and SCI -**  **GROW Models** Chemical Surface water EDWCs (ppb) Groundwater Acute/Chronic EDWC (ppb) Peak 96 hour average Peak annual

average 30 Y ear Average Total Toxic Residues of amicarbazone 33.3 25.8 11.1 **136** EDWCs would be reduced if degradates were not assumed to be of equal toxic ity as parent amicarbazone or if unextracted residues were determined to be bound residues. Exclusion of degradates and bound residue results in reduction of EDWCs by as much as 70%. Exclusion of bound residue s results in reduction of EDWCs by as much as 20%. **V. DEEM**  **- FCIDTM Program and Consumption Information**  A micarbazone acute and chronic dietary exposure assessments were conducted using the Dietary Exposure Evaluation Model software with the Food Commodity I ntake Database DEEM -Amicarbazone Dietary Exposure and Risk Assessment PC Code: 114004 DP Number: D 394925

Page 5 of 12 FCIDTM,Version 2.03 which inco rporates consumption data from USDA’s 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 day s. Foods “as consumed” (e.g., apple pie) are linked to EPA - defi ned food commodities (e.g. apples, peeled fruit - cooked; fresh or N/S; baked; or wheat flour - cooked; fresh or N/S, baked) using publicl y available recipe translation files developed jointly

by USDA/ARS and EPA. For chronic exposure assessment, consumpt ion 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 anal ys is of the 1994 - 96, 98 CSFII consumption data, which took into account die tary 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 ye ar old), children 1 - 2, children 3 - 5, children 6 - 12, y outh 13 - 19, adults 20 - 49, females 13 - 49, and adults 50+ y ears old. For chronic dietary

exposure assessment, an estimate of the residue level in each food or food form (e.g., orange or orange juice) on the food commodity residue list is multiplied by the average dail y consumpt ion 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 bod y 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 “matched” 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., onl y 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 anal ysis. However, for tiers 1 and 2, an y significant di fferences in user vs. per capita exposure and risk are specificall y identified and noted in the risk assessment. **V I**  **. Toxicological Information**  Adequate data have been submitted to characterize the toxicity o f amicarbazone for the purposes of dietary risk assessment. Acute and chronic dietary endpoints were selected for the general U.S. population and all population subgroups including those comprised of infants and children. The toxicological doses and endpoints selected for human health risk assessment are summarized in Table 3, below. The FQPA Safet y Factor was reduced to 1x. A micarbazone is classified as “not likely

to be a human carcinogen.”Amicarbazone Dietary Exposure and Risk Assessment PC Code: 114004 DP Number: D 394925

Page 6 of 12 **Table 3. Summary of Toxicological Doses and Endpoints for Amicarbazo ne for Use in Dietary**  **Human Health Risk Assessments Exposure/**  **Scenario Point of** 

**Departure Uncertainty/FQP** 

**A Safety Factors RfD, PAD,** 

**Level of Concern for**  **Risk Assessment**  **Study and Toxicological Effects** Ac ute Dietary (General Population, including Infants and Children and Fem ales 13 - 49 years of age ) NOAEL=

10 mg/kg/day UF A= 10 x

UF H = 10 x FQPA SF= 1 x Ac ute RfD =

0.10 mg/kg/day aPAD = 0.10 mg/kg/day Ac ute Oral Neurotoxicity Screening

Battery LOAEL = 20 mg /kg/day based on eyelid ptosis, decreased approach response and red nasal staining in females Chronic Dietary (General Population, including Infants and Children and Fem ales 13 - 49 years of age ) NOAEL=

2.3 mg/kg/day UF A= 10 x

UF H = 10 x FQPA SF= 1 x Chronic RfD

= 0.023 mg/kg/day cPAD = 0.023 mg/kg/day Chronic Oral Rat and Chronic Oral Dog

(co - critical) **Rat** LOAEL = 25.3 mg /kg/day based on decreased body weight and weight gain **Dog** LOAEL = 8.7 mg/kg/day based on liver effects, including increased absolute/relative liver w eights, triglycerides and cholesterol Cancer (oral, dermal, inhalation) Classification: There w as no treatment - related increase in tumor incidence when compared to

control. Dosing was considered adequate. This chemical is not likely to be a carcinogen. Point of Departure (POD) = A data point or an estimated point that is derived from observed dose - response data and used to mark the beginning of extrapolation to determine risk associated with lower environmentally relevant human exposures. NOAEL = no ob served adverse effect level. LOAEL = lowest observed adverse effect level. UF = uncertainty factor. UF A = extrapolation from animal to human (interspecies). UF H = potential variation in sensitivity among members of the human population (intraspecies). FQPA SF = FQPA Safety Factor. PAD = population adjusted dose (a = acute, c = c hronic). RfD = reference dose. **V I**  **I. Results/Discussion**  As stated above, for acute and chronic assessments, HED is concerned when dietary risk exceeds 100% of the PAD. T he DEEM - FCIDTM anal ys es estimate the dietary exposure of the U.S. population and various population subgroups. The results reported in Table 5 are for the general U.S. Population, all infants (<1 y ear old), children 1 - 2, children 3 - 5, children 6 - 12, y outh 13 - 19, females 13 - 49, adults 20 - 49, and adults 50+ years. Risk estimates are below HED’s level of concern for all population subgroups in both the acute and chronic analy ses. The acute risk estimate for the general U.S. population is 8.8 % of the aPAD. The population subgroup with the highest acute risk estimate is All Infants , which uses 29 % of the aPAD. The chronic risk estimate for the general U.S. population is 17 % of the cPAD. The most highl y exposed population subgroup is All Infants , which uses 48 % of the cPAD. As amicarbazone is not likely to be a human carcinogen , a dietary exposure assessment for the purpose of assessing cancer risk is not n ecessary .Amicarbazone Dietary Exposure and Risk Assessment PC Code: 114004 DP Number: D 394925

Page 7 of 12 Full listings of exposure and risk estimates are included in Attachments 2 (acute anal ys is) and 3 (chronic anal ys is). **Table 4**  **. Summary of Acute and Chronic Dietary (Food and Drinking Water)**  **Exposure and Risk Estimates for**  **A micarbazone**  Population Subgroup Ac ute Assessment (95 th Percentile) Chronic Assessment

a PAD, mg/day Exposure Estimate,

mg/day % a Pad c PAD, mg/day Exposure Estimate,

mg/day % c Pad U.S. Population 0.10 0.0 08807 8.8 0. 023 0.0 03889 17 **All infants** 0.10 **0.029429 29**  0.023 **0.0 10987**  **4 8**  Children 1 - 2 y

rs 0.10 0. 014750 15 0.023 0.0 06921 30 Children 3 - 5 y

rs 0.10 0. 013469 13 0.023 0.0 06474 28 Children 6 - 12 y

rs 0.10 0.0 09356 9.4 0.023 0.0 04469 19 Youth 13 - 19 y

rs 0.10 0.0 06999 7.0 0.023 0.0 03120 14 Ad ults 20 - 49 y

rs 0.10 0.0 07621 7.6 0.023 0.0 03472 15 Ad ults 50+ yrs 0.10 0.0 06711 6.7 0.023 0.0 03441 15 Fem ales 13 - 49 y

rs 0.10 0. 007603 7.6 0.023 0.0 03431 15 As drinking water is a major contributor to dietary risk for the general U.S. population and all population subgroups, commodity contribution analy ses were performed to determine the contribution of drinking water to the total dietary exposure estimates. Inthe acute anal ys es, drinking water contributed between 76% and 90% of the total exposure . In the chronic anal ys es, drinking water contributed between 62% and 86% of the total exposure. The results of the anal ys es are given in Table 5 , below.

**Table 5**  **. Contribution of Residues in Drinking Water to Total Dietary**  **Exposure** Population Subgroup Ac ute Assessment % of Total Dietary Exposure Chronic Assessment % of Total Dietary Exposure U.S. Population 80 74 All infants 90 86 Children 1 - 2 y

rs 74 62 Children 3 - 5 y

rs 76 62 Children 6 - 12 y

rs 76 62 Youth 13 - 19 y

rs 85 66 Ad ults 20 - 49 y

rs 88 77 Ad ults 50+ yrs 90 82 Fem ales 13 - 49 y

rs 89 78Amicarbazone Dietary Exposure and Risk Assessment PC Code: 114004 DP Number: D 394925

Page 8 of 12 **VI I**  **I. Characterization of Inputs/Outputs**  HED considers b oth the acute and chronic assessments to be very conservative . For amicarbazone, drinking water is the greatest contributor to dietary exposure and risk. T he EDWCs represent upper - bound estimates that mi ght be found in surface water and groundwater as a result of the application of amicarbazone on turf and conifers one time at the maximum ye arl y rate (worst case scenario). The EDWCs would be reduced if degradates were not assumed to be of equal toxic ity as parent amicarbazone or if unextracted residues were determined to be bound residues. Exclusion of degradates and bound residue results in reduction of EDWCs by as much as 70%. Exclusion of bound residue s results in reduction of EDWCs by as much as 20% . Although food commodities do not contribute significantly to the total dietary

exposure, minor reductions in the exposure and risk estimates could be made through the use of refinements. The assessments are based on tolerance - level residues for all commodities . Conservative processing factors were used for all processed commodities for which they were available. In addition, it i s assumed that 100% of all crops with re gistered uses of amicarbazone are treated. Further refinements to these analy ses could be made through the use of anticipated residues (e.g., distributions of field trial data for the acute assessment and average field trial values for the chronic assessment) and percent crop treated estimates. Ho wever, as all risk estimates are not of concern, it is not necessary to make any

refinements to the dietary exposure assessments. **I X**  **. Conclusions**  The exposure estimates that were generat ed are very conservative estimates of the actual dietary expos ures that m ight occur. T he aggregate (food + water) dietary risk estimates are below HED’s level of concern for all population subgroups for both the acute and chronic exposure scenarios. HED is confident that the acute and chronic dietary exposure assessments do not underestimate risk to the general U.S. population or an y population subgroup. **X. List of Attachments**  Attachment 1. A cute and Chronic D ietary Residue Input File for Amicarbazone Attachment 2. Results of Acute Dietary Exposure Assessment Attachment 3 . Results of Chronic Dietary Exposure AssessmentAmicarbazone Dietary Exposure and Risk Assessment PC Code: 114004 DP Number: D 394925

Page 9 of 12 Attachment 1: Acute and Chronic Dietary Residue Input F ile for A micarbazone DEEM FCID Version 2.03 Acute NO A EL for general population and all population subgroups : 1 0 mg/kg bw/day Acute PAD for general population and all population subgroups : 0.10 mg/kg bw/day Chronic NO A EL for general population and all population subgroups : 2.3 mg/kg bw/day Chronic PAD for general population and all population subgroups : 0.023 mg/kg bw/day Filename: C: \

Documents and Settings \ddotson\My Documents \Deemfcid\ Amicarbazone \

Amicarbazone2011.R98 Date created/last modified: 10 - 01 - 2011/14:33:04/8

-------------------------------------------------------------------------------- EPA Crop Def Res Adj.Factors Comment Code Grp Commodity Name (ppm) #1 #2

-------- ---- ------ ------------------------- ---------- ------ ------ ------- 06003470 6 Soybean, seed 0.800000 1.000 1.000 06003480 6 Soybean, flour 0.800000 1.000 1.000 06003481 6 Soybean, flour - babyfood 0.800000 1.000 1.000 06003490 6 Soybean, soy milk 0.800000 1.000 1.000 06003491 6 Soybean, soy milk - babyfood or in 0.800000 1.000 1.000 06003500 6 Soybean, oil 0.800000 1.000 1.000 06003501 6 Soybean, oil - babyfood 0.800000 1.000 1.000 15001200 15 Corn, field, flour 0.050000 1.000 1.000 15001201 15 Corn, field, flour - babyfood 0.050000 1.000 1.000 15001210 15 Corn, field, meal 0.050000 1.000 1.000 15001211 15 Corn, field, meal - babyfood 0.050000 1.000 1.000 15001220 15 Corn, field, bran 0.050000 1.000 1.000 15001230 15 Corn, field, starch 0.050000 1. 000 1.000 15001231 15 Corn, field, starch - babyfood 0.050000 1.000 1.000 15001240 15 Corn, field, syrup 0.050000 1.500 1.000 15001241 15 Corn, field, syrup - babyfood 0.050000 1.500 1.000 15001250 15 Corn, field, oil 0.050000 1.000 1.000 15001251 15 Corn, field, oil - babyfood 0.050000 1.000 1.000 15004010 15 Wheat, grain 0.170000 1.000 1.000 15004011 15 Wheat, grain - baby food 0.170000 1.000 1.000 15004020 15 Wheat, flour 0.255000 1.000 1.000 15004021 15 Wheat, flour - babyfood 0.255000 1.000 1.000 15004030 15 Wheat, germ 0.255000 1. 000 1.000 15004040 15 Wheat, bran 0.255000 1.000 1.000 21000440 M Beef, meat 0.012000 1.000 1.000 21000441 M Beef, meat - babyfood 0.012000 1.000 1.000 21000450 M Beef , meat, dried 0.012000 1.920 1.000 21000460 M Beef, meat byproducts 0.120000 1.000 1.000 21000461 M Beef, meat byproducts - babyfood 0.120000 1.000 1.000 21000470 M Beef, fat 0.010000 1.000 1.000 21000471 M Beef,fat - babyfood 0.010000 1.000 1.000 21000480 M Beef, kidney 0.120000 1.000 1.000 21000490 M Beef, liver 1.000000 1.000 1.000 21000 491 M Beef, liver - babyfood 1.000000 1.000 1.000 23001690 M Goat, meat 0.012000 1.000 1.000 23001700 M Goat, meat byproducts 0.120000 1.000 1.000 23001710 M Goat, fat 0.010000 1.000 1.000Amicarbazone Dietary Exposure and Risk Assessment PC Code: 114004 DP Number: D 394925

Page 10 of 12 23001720 M Goat, kidney 0.120000 1.000 1.000 23001730 M Goat, liver 1.000000 1.000 1.000 24001890 M Horse, meat 0.012000 1.000 1.000 25002900 M Pork, meat 0.012000 1.000 1.000 25002901 M Pork, meat - babyfood 0.012000 1.000 1.000 25002910 M Pork, skin 0.012000 1.000 1.000 25002920 M Pork, meat byproducts 0.012000 1.000 1.000 25002921 M Pork, meat byproducts - babyfood 0.012000 1.000 1.000 25002930 M Pork, fat 0.010000 1.000 1.000 25002931 M Pork, fat - babyfoo d 0.010000 1.000 1.000 25002940 M Pork, kidney 0.012000 1.000 1.000 25002950 M Pork, liver 0.100000 1.000 1.000 26003390 M Sheep, meat 0.012000 1. 000 1.000 26003391 M Sheep, meat - babyfood 0.012000 1.000 1.000 26003400 M Sheep, meat byproducts 0.120000 1.000 1.000 26003410 M Sheep, fat 0.010000 1.000 1.000 26003411 M Shee p, fat - babyfood 0.010000 1.000 1.000 26003420 M Sheep, kidney 0.120000 1.000 1.000 26003430 M Sheep, liver 1.000000 1.000 1.000 27002220 D Milk, fat 0.016000 1.000 1.000 27002221 D Milk, fat - baby food/infant for 0.016000 1.000 1.000 27012230 D Milk, nonfat solids 0.016000 1.000 1.000 27012231 D Milk, nonfat solids - baby food/in 0.016000 1.000 1.000 27022 240 D Milk, water 0.016000 1.000 1.000 27022241 D Milk, water - babyfood/infant form 0.016000 1.000 1.000 27032251 D Milk, sugar (lactose) - baby food/ 0.016000 1.000 1.000 40000940 P Chicken, liver 0.018000 1.000 1.000 50003830 P Turkey, liver 0.018000 1.000 1.000 60003020 P Poultry, other, liver 0.018000 1.000 1.000 86010000 O Water, direct, all sources 0.136000 1.000 1.000 86020000 O Water, indirect, all sources 0.136000 1.000 1.000 95001280 O Cottonseed, oil 0.070000 1.000 1.000 95001281 O Cottonseed, oil - babyfood 0.070000 1.000 1.000Amicarbazone Dietary Exposure and Risk Assessment PC Code: 114004 DP Number: D 394925

Page 11 of 12 Attachment 2: Results of Acute Dietary Exposure Assessment Residue file: Amicarbazone2011 .R98 Analy sis Date: 10 - 01 - 2011/14:39:50 Residue file dated: 10 - 01 - 2011/14:33:04/8 Daily totals for food and foodform consumption used.

=============================================================================== Summary calculations (per capita): 95th Percentile 99th Percentile 99.9th Percentile Exposure % aRfD MOE Exposure % aRfD MOE Ex posure % aRfD MOE

---------- ------- -------- ---------- ------- -------- ---------- ------- -------- U.S. Population: 0.008807 8.81 1135 0.015320 15.32 652 0.029257 29.26 341 All infants: 0.029429 29.43 339 0. 042121 42.12 237 0.071274 71.27 140 Children 1 - 2 yrs: 0.014750 14.75 677 0.023625 23.62 423 0.041600 41.60 240 Children 3 - 5 yrs: 0.013469 13.47 742 0.019734 19.73 506 0.035375 35.37 282 Children 6 - 12 yrs: 0.009356 9.36 1068 0.014263 14.26 701 0.019715 19.72 507 Youth 13 - 19 yrs: 0.006999 7.00 1428 0.010993 10.99 909 0.018113 18.11 552 Adults 20 - 49 yrs: 0.007621 7.62 1312 0.012089 12.09 827 0.020763 20.76 481 Adults 50+ yrs: 0.006711 6.71 1490 0.009375 9.38 1066 0.015091 15.09 662 Females 13 - 49 yrs: 0.007603 7.60 1315 0.011946 11.95 837 0.019959 19.96 501Amicarbazone Dietary Exposure and Risk Assessment PC Code: 114004 DP Number: D 394925

Page 12 of 12 Attachment 3 : Results of Chronic Dietary Exposure Assessment Residue file name: C: \

Documents and Settings \ ddotson\ My Documents \Deemfcid\ Amicarbazone \

Amicarbazone2011.R98 Residue file dated: 10 - 01 - 2011/14:33:04/8 Analy s is Date : 10 - 01 - 2011/14:42:17

=============================================================================== Total exposure by population subgroup

------------------------------------------------------------------------------- Total Exposure

----------------------------------- Population mg/kg Percent of Subgroup body wt/day Rfd

-------------------------------------- ------------- --------------- U.S. Population (total) 0.003889 16.9% U.S. Population (spring sea son) 0.003870 16.8% U.S. Population (summer season) 0.004080 17.7% U.S. Population (autumn season) 0.003802 16.5% U.S. Population (winter season) 0.003802 16.5% Northeast region 0.003623 15.8% Midwest region 0.003978 17.3% Southern region 0.003704 16.1% Western region 0.004327 18.8% Hispanics 0.004292 18.7% Non - hispanic whites 0.003811 16.6% Non - hispanic blacks 0.003751 16.3% Non - hisp/non
- white/non
- black 0.004624 20.1% All infants (< 1 year) 0.010987 47.8% Nursing infants 0.004012 17.4% Non - nursing infants 0.013634 59.3% Children 1 - 6 yrs 0.006499 28.3% Children 7 - 12 yrs 0.004243 18.4% Females 13 - 19 (not preg or nursing) 0 .002931 12.7% Females 20+ (not preg or nursing) 0.003535 15.4% Females 13 - 50 yrs 0.003588 15.6% Females 13+ (preg/not nursing) 0.003671 16.0% Females 13+ (nursing) 0.004902 21.3% Males 13 - 19 yrs 0.003284 14.3% Males 20+ yrs 0.003361 14.6% Seniors 55+ 0.003431 14.9% Children 1 - 2 yrs 0.006921 30.1% Children 3 - 5 yrs 0.006474 28.1% Children 6 - 12 yrs 0.004469 19.4% Youth 13 - 19 yrs 0.003120 13.6% Adults 20 - 49 yrs 0.003472 15.1% Adults 50+ yrs 0.003441 15.0% Females 13 - 49 yrs 0.003431 14.9%

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