Topramezone Dietary Exposure and Risk Assessment 

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

DP# 400947 

OFFICE OF CHEMICAL SAFETY AND 

POLLUTION PREVENTION 

MEMORANDUM 

Date: 15-MA Y-2013 

SUBJECT: Topramezone. Acute and Chronic Aggregate Dietary (Food and Drinking 

Water) Exposure and Risk Assessments for the Section 3 Registration Action 

Concerning Non-crop Aquatic Application. 

PC Code: 123009 DP Barcode: D400947 

Decision No.: 462026 Registration No.: 7969-XXX 

Petition No.: 2F7997 Regulatory Action: Section 3 Registration 

Risk Assessment Type: Dietary Case No.: 7268 

TXR No.: N/A CAS No.: 210631-68-8 

MRID No.: N/A 40 CFR: §1 80.612 

FROM: Sarah J. Levy, Chemist M (} ~ / ' 

Risk Assessment Branch l (RAB 0/He:i"t{ Effects Division (HED; 7509P) 

THROUGH: Nancy 

Ideliz Negro

Dodd, 

n-Encarnacion

Chemist ~~ 

, Chemist ;?1(1 L--

Dietary Exposure Science Advisory CounciY(DESAC)/HED (7509P) 

and 

George F. Kramer, Ph.D., Branch Senior Scientist 

RAB lll-IED (7509P) 

TO: Chester Rodriguez, Ph.D., Pharmacologist 

RAB 1/HED (7509P) 

and 

Kathryn Montague/Bethany Benbow (RM 23) 

Registration Division (RD; 7505P) 

Page I of 13 
Topramezone Dietary Exposure and Risk Assessment DP# 400947 

Executive Summary 

Unrefined acute and chronic aggregate dietary (food + drinking water) exposure and risk 

assessments were conducted for topramezone ([3-(4,5-dihydro-3-isoxazolyl)-2-methyl-4-

( me thy lsulfony l)pheny l] ( 5-hydroxy -1-methy 1-1 H-pyrazol-4-yl )methanone) using the Dietary 

Exposure Evaluation Model software with the Food Commodity Intake Database (DEEM-FCID) 

Version 3.16, which uses food consumption data from the U.S. Department of Agriculture's 

National Health and Nutrition Examination Survey, What We Eat in America, 

(NHANES/WWEIA). This dietary survey was conducted from 2003 to 2008. Acute and chronic 

analyses were performed to support a request for a Section 3 registration for the non-crop aquatic 

application oftopramezone and proposed tolerances for residues oftoprarnezone per se inion 

fish and shellfish at 0.05 ppm. The unrefined acute and chronic analyses assumed tolerancelevel residues, 100% crop treated (CT), DEEM (ver. 7.81) default processing factors, and 

modeled drinking water numbers. 

These analyses have been reviewed by two peer reviewers of the DESAC, per the DESAC 

Standard Operating Procedure (SOP) 2012.1. 

Acute Dietary (Food+ Drinking Water) Exposure Results and Characterization 

Two separate acute analyses were conducted as there were two different points of departure 

(PODs) identified: one for the general U.S. population (including infants and children) and one 

for females 13-49 years of age. Both unrefined acute analyses assumed 100% CT, DEEM 7.81 

default processing factors, and tolerance-level residues. Drinking water numbers were 

incorporated directly into the acute dietary assessments. The estimated drinking water 

concentrations (EDWCs) were based on the proposed use for water bodies with functional 

potable water intakes, which cannot exceed 45 ppb. 

The acute dietary exposure and risk estimates (food+ drinking water) were estimated at 

0.002541 mg/kg/day for the general U.S. population ((32% ofthe acute population-adjusted dose 

(aPAD)] and 0.007829 mg/kg/day (98% of the aP AD) for the most highly exposed population 

subgroup (all infants <1 year old) and are thus below HED's level of concern (<100% aPAD). 

The resulting acute dietary exposure and risk estimates using the DEEM-FCID model at the 95111 

percentile for females 13-49 years of age was 0.002508 mg/kg/day (50% of the aP AD) and is 

below HED's level of concern (<100% aPAD). 

Chronic Dietary (Food + Drinking Water) Exposure Results and Characterization 

The chronic analysis assumed 100% CT, DEEM 7.81 default processing factors, and tolerancelevel residues. EDWCs were incorporated directly into the chronic dietary assessments. The 

resulting chronic (food + drinking water) risk estimates were less than HED' s LOC ( < 1 00% of 

the chronic population-adjusted dose ( cPAD)) for the general U.S. population (25% of the 

cP AD) and all population subgroups. The most highly exposed population subgroup was all 

infants (<1 year old) with an estimated exposure equivalent to 62% of the cPAD; therefore, the 

chronic dietary exposure to topramezone is below HED's level of concern. 

A chronic cancer dietary assessment was not conducted since it was determined that 

toprarnezone is not likely to be a human carcinogen. 

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Topramezone Dietary Exposure and Risk Assessment DP# 400947

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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 PAD. The PAD is equivalent to a POD (NOAEL, LOAEL, e.g.) 

divided by the required uncertainty or safety 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 Assessing 

Exposure from Pesticides, A User’s Guide,” 21-JUN-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 most recent dietary risk assessment for topramezone was conducted by Sarah Levy (06-

JUN-2012; DP# 388806).

II. Residue Information

Residues of Concern: HED concluded that topramezone per se is the residue of concern, for 

purposes of tolerance enforcement and risk assessment, in corn, rotational crops, and ruminants 

(Memo, G. Kramer, 11-May-2005; D310772). The petitioner has not submitted a poultry 

feeding study. HED previously waived the poultry feeding study as, based on the poultry 

metabolism study and the MRDB at that time, there was no reasonable expectation of finite 

residues (180.6(a)(3); Memo, G. Kramer, 11-May-2005; D310772). Based on the low residues 

seen in muscle, fat, and egg, the conservative nature of the poultry MRDB calculation, the 

extended dosing interval employed in the metabolism study (10 days), and since poultry meat 

byproducts is a minor food commodity, HED concluded that a poultry feeding study is 

unnecessary. However, based on the available data, a poultry meat byproduct tolerance for 

residues of topramezone per se should be established at 0.02 ppm (revised Section F is 

requested; see the following memorandum for more details: T. Bloem, 26-FEB-2013; D400949). 

For drinking water, topramezone per se is the residue of concern for risk assessment purposes 

(Memo, M. Clock-Rust, 11-MAY-2005; D390075).

Established Tolerances: Topramezone is a broad-spectrum systemic herbicide which inhibits 

carotenoid biosynthesis in susceptible plants (4-hydroxyphenylpyruvate dioxygenase (HPPD) 

inhibitor). In the absence of carotene, chlorophyll is rapidly degraded in sunlight. Topramezone 

is registered for use on golf courses, sod farms, residential turfgrass, non-crop ornamentals, 

rights-of-way, tree plantations, and other non-crop areas, as well as for application to corn (field, 

pop, seed, and sweet) with tolerances on corn commodities ranging from 0.01 to 0.05 ppm (40 

CFR §180.612). Tolerances are also established in 40 CFR §180.612 on kidney (0.05 ppm) and 

liver (0.15 ppm) of cattle, goat, horse, and sheep. 

HED-Recommended Tolerances: In accordance with the most recent guidance concerning 

tolerance expressions, HED recommends that the tolerance expression for 180.612(a)(1) be 

changed as indicated below (Memo, T. Bloem, 26-FEB-2013; D400949). A revised Section F 

should be submitted which specifies the new tolerance expression and the HED recommended 

commodity definitions and tolerance levels. With the establishment of the tolerances indicated 
Topramezone Dietary Exposure and Risk Assessment DP# 400947

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in Table 1, the currently established kidney (cattle, goat, horse, and sheep) and liver (cattle, goat, 

horse, and sheep) tolerances should be deleted. 

180.612(a)(1) Tolerances are established for residues of the herbicide topramezone, including its 

metabolites and degradates, in or on the commodities listed below. Compliance with the following 

tolerance levels is to be determined by measuring only topramezone ([3-(4,5-dihydro-3-isoxazolyl)-2-

methyl-4-(methylsulfonyl)phenyl](5-hydroxy-1-methyl-1H-pyrazol-4-yl)methanone) in or on the 

following commodities:

Table 1. Summary of Tolerances.

Commodity Proposed 

Tolerance (ppm)

HED-Recommended 

Tolerance (ppm)

fish 0.05 0.05

shellfish 0.05 0.05

meat byproducts 

(cattle, goat, horse, and sheep) -- 0.80 These tolerances are recommended as a 

result of the increased livestock dietary 

burdens associated with the proposed 

use. 

meat byproducts (hog) -- 0.40

meat byproducts (poultry) -- 0.02

The unrefined acute and chronic analyses assumed tolerance-level residues, 100% CT, DEEM 

(ver. 7.81) default processing factors, and modeled water numbers.

III. Percent Crop Treated Information

A default of 100% CT was assumed for the acute and chronic dietary exposure assessments.

IV. Drinking Water Data

The drinking water residues used in the dietary risk assessment were provided by the 

Environmental Fate and Effects Division (EFED) (J. Wolf, 29-JAN-2013; DP# 408687) and 

incorporated directly into the acute and chronic dietary assessments. Estimated drinking water 

concentrations (EDWCs) were incorporated directly into DEEM-FCID under the food categories 

“water, direct, all sources” and “water, indirect, all sources.” To date, no monitoring data are 

available for parent topramezone. 

The highest topramezone EDWC is expected to result from the direct aquatic applications. 

Although the highest proposed concentration in water is 50 ppb, the proposed use for water 

bodies with functional potable water intakes cannot exceed 45 ppb; therefore, this is the highest 

potential concentration recommended for drinking water. The highest topramezone EDWC is 

expected to result from the direct aquatic applications. 

V. DEEM-FCID Program and Consumption Information

Topramezone acute and chronic dietary risk assessments were conducted using DEEM-FCID, 

Version 3.16, which incorporates consumption data from USDA’s NHANES/WWEIA. This 

dietary survey was conducted from 2003 to 2008. The data are based on the reported 

consumption of more than 20,000 individuals over two non-consecutive survey days. Foods “as 

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. However, for acute exposure assessment, consumption data are retained 
Topramezone Dietary Exposure and Risk Assessment DP# 400947

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as individual consumption events. Based on analysis of the 2003-2008 WWEIA 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 50-99 years old.

For a chronic dietary exposure assessment, an estimate of the residue level in each food or foodform (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 an acute exposure assessment, 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., 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 analyses performed at all levels of refinement. However, for 

deterministic assessments, any significant differences in user vs. per capita exposure and risk are 

specifically identified and noted in the risk assessment.

VI. Toxicological Information

Table 2 is a summary of the toxicological doses and endpoints selected that are relevant to 

dietary risk assessment (Memo, K. Lowe, 02-FEB-2012; D388367).

Table 2. Toxicological Doses and Endpoints for Topramezone for Use in Dietary Risk Assessments.

Exposure

Scenario POD

Uncertainty/FQPA SFs 

or LOC for Risk 

Assessment

Study and Toxicological Effects

Acute Dietary

(General population 

including infants and 

children)

LOAEL = 8 mg/kg bw UF = 100X

(for inter- and intraspecies extrapolation)

FQPA SF =10X

aRfD =0.008 mg/kg bw

aPAD = 0.008 mg/kg 

bw

Developmental Neurotoxicity Study in Rats

Offspring LOAEL = 8 mg/kg bw based on 

decreased maximum auditory startle reflex 

response, decreased brain weights, and 

changes in brain morphology.

Acute Dietary 

(Females 13-50 

years old)

NOAEL = 0.5 

mg/kg/day

UF = 100X

(for inter- and intraspecies extrapolation)

FQPA SF= 1X

aRfD = aPAD = 0.005 

mg/kg/day

Developmental Toxicity Study in Rabbits

LOAEL = 5 mg/kg/day based on alterations in 

skeletal ossification sites and increased 

number of pairs of ribs.

Chronic Dietary

(All populations)

NOAEL= 0.4 

mg/kg/day

UF = 100X

(for inter- and intraspecies extrapolation)

FQPA SF = 1X

Chronic toxicity/Carcinogenicity Study in 

Rats

LOAEL = 3.6 mg/kg/day based on increased 

incidences of corneal opacity, decreased body 

weight and body-weight gains in males and 
Topramezone Dietary Exposure and Risk Assessment DP# 400947

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Table 2. Toxicological Doses and Endpoints for Topramezone for Use in Dietary Risk Assessments.

Exposure

Scenario POD

Uncertainty/FQPA SFs 

or LOC for Risk 

Assessment

Study and Toxicological Effects

cRfD = cPAD

= 0.004 mg/kg/day

histopathological evaluations in the thyroid, 

pancreas, and eyes of both sexes.

Cancer 

(Oral, dermal, 

inhalation)

In accordance with the EPA Final Guidelines for Carcinogen Risk Assessment (March 29, 2005), the 

CARC classified topramezone as “Not likely to be carcinogenic to humans at doses that do not alter 

rat thyroid hormone homeostasis.” The Cancer Assessment Review Committee (CARC) determined 

that quantification of human cancer risk is not required since the NOAEL (0.4 mg/kg/day) for noncancer risk assessment is not expected to alter thyroid hormone homeostasis nor result in thyroid 

tumor formation.

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-observed adverse-effect level. 

LOAEL = lowest-observed adverse-effect level. UF = uncertainty factor. FQPA SF = FQPA Safety Factor. PAD = population-adjusted dose (a 

= acute, c = chronic). RfD = reference dose. MOE = margin of exposure. LOC = level of concern.

VII. Results/Discussion 

As stated above, for acute and chronic assessments, HED is concerned when dietary risk exceeds 

100% of the PAD. The DEEM-FCID analyses estimate the dietary exposure of the U.S. 

population and various population subgroups. The results of the acute and chronic dietary risk 

estimates reported in Table 3 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 

50-99 years old. 

 

Acute Dietary (Food + Drinking Water) Exposure Results and Characterization

Two separate acute analyses were conducted as there were two different PODs identified: one 

for the general U.S. population (including infants and children) and one for females 13-49 years 

of age. Both Tier 1 acute analyses assumed 100% crop treated, DEEM 7.81 default processing 

factors and tolerance-level residues. Drinking water was incorporated directly in the dietary 

assessments using the 1-in-10-year annual peak concentration for surface water generated by the 

PRZM-EXAMS model. 

The acute dietary exposure and risk estimates (food + drinking water) were estimated at 

0.002544 mg/kg/day for the general U.S. population (32% of the aPAD) and 0.007840 

mg/kg/day (98% of the aPAD) for the most highly exposed population subgroup (all infants <1 

year old) and are thus below HED’s level of concern (<100% aPAD). These results are shown

for the 95th percentile of exposure, as all inputs were unrefined.

The resulting acute dietary exposure and risk estimate using the DEEM-FCID model at the 95th

percentile for females 13-49 years of age was 0.002508 mg/kg/day (50% of the aPAD) and is 

below HED’s level of concern (<100% aPAD). 

Acute dietary exposure to topramezone is below HED’s level of concern for all populations. 

Chronic Dietary (Food + Drinking Water) Exposure Results and Characterization

The chronic analysis assumed 100% CT, DEEM 7.81 default processing factors, and tolerancelevel residues. EDWCs were incorporated directly into the chronic dietary assessments. The 

resulting chronic (food + drinking water) risk estimates were less than HED’s LOC (<100% 

cPAD) for the general U.S. population (25% of the cPAD) and all population sub-groups; the 

most highly exposed population subgroup was all infants (<1 year old), which utilized 62% of 
Topramezone Dietary Exposure and Risk Assessment DP# 400947

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the cPAD. Therefore, the chronic dietary exposure to topramezone is not of concern to HED. A 

chronic cancer dietary assessment was not conducted since it was determined that topramezone 

is not a possible human carcinogen. 

Table 3. Summary of Acute and Chronic Dietary (Food + Drinking Water) Exposure and Risk for 

Topramezone.

Population Subgroup1

Acute Dietary2

(95 Percentile) Chronic Dietary3 Cancer

Dietary

Exposure 

(mg/kg/day)

% aPAD

Dietary 

Exposure

(mg/kg/day)

% cPAD

Dietary 

Exposure

(mg/kg/day)

Risk

General U.S. Population 0.002541 32 0.000998 25

N/A N/A

All Infants (<1 year old) 0.007829 98 0.002487 62

Children 1-2 years old 0.004041 51 0.001487 37

Children 3-5 years old 0.003230 40 0.001263 32

Children 6-12 years old 0.002467 31 0.000913 23

Youth 13-19 years old 0.002098 26 0.000738 19

Adults 20-49 years old 0.002469 31 0.000989 25

Adults 50-99 years old 0.002205 28 0.000971 24

Females 13-49 years old 0.002508 50 0.000978 25

1

 The highest dietary exposure estimate for each type of risk assessment is bolded.

2

 Acute dietary POD of 0.008 mg/kg/day applies to the general U.S. population, including infants and children. Acute dietary 

endpoint of 0.005 mg/kg/day applies to the females 13-49 years old population subgroup only. 

3

 Chronic dietary POD of 0.004 mg/kg/day applies to the general U.S. population and all population subgroups. The values for 

the highest exposed population are bolded.

VIII.Characterization of Inputs/Outputs

The acute and chronic analyses assumed tolerance-level residues, 100% CT, DEEM default 

processing factors, and included modeled water values. Therefore, these analyses were 

considered highly conservative and could be further refined if needed through the use of 

anticipated residues (ARs) for all commodities, % market share data for the proposed 

commodities, %CT data for registered commodities, empirical processing factors, and/or 

monitoring data for drinking water. However, as there are no risk estimates of concern, 

refinements are not necessary at this time.

IX. Conclusions

Unrefined acute and chronic aggregate (food + drinking water) dietary exposure and risk 

assessments were conducted to support a request for a Section 3 registration for the non-crop

aquatic application of topramezone and proposed tolerances for residues of topramezone per se

in/on fish and shellfish. The analyses were conducted using the DEEM-FCID (ver. 3.16) model 

and assumed tolerance-level residues, 100% CT, and DEEM default processing factors. The 

resulting acute and chronic aggregate risk estimates are below HED’s LOC. HED is confident 

that the assessments do not underestimate risk to the general U.S. population or any population 

subgroup.
Topramezone Dietary Exposure and Risk Assessment DP# 400947

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X. List of Attachments

Attachment 1: Acute Food + Drinking Water Residue Input File.

Attachment 2: Acute (General U.S. Population) Results File.

Attachment 3: Acute (Females 13-49 years old) Results File.

Attachment 4: Chronic Food + Drinking Water Residue Input File.

Attachment 5: Chronic Results File.

RDI: DESAC (30-JAN-2013); G.F. Kramer (31-JAN-2013)

S. Levy:S10953:PY1:(703)305-0783:7590P
Topramezone Dietary Exposure and Risk Assessment DP# 400947

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Attachment 1: Acute Food + Drinking Water Residue Input File.

US EPA Ver. 3.16, 03-08-d

DEEM-FCID Acute analysis for TOPRAMEZONE

Residue file name: C:\Documents and 

Settings\slevy\Desktop\Topramezone\123009a.R08

Analysis Date 02-01-2013 Residue file dated: 02-01-2013/09:22:48

Reference dose (aRfD) = 0.008 mg/kg bw/day

Comment: acute

--------------------------------------------------------------------------

 EPA Crop Def Res Adj.Factors 

Comment

 Code Grp Food Name (ppm) #1 #2 

---------- ---- ---------------------- ---------- ------ ------ -------

3100046000 31 Beef, meat byproducts 0.800000 1.000 1.000

3100046001 31 Beef, meat byproducts-babyfood 0.800000 1.000 1.000

3100048000 31 Beef, kidney 0.800000 1.000 1.000

3100049000 31 Beef, liver 0.800000 1.000 1.000

3100049001 31 Beef, liver-babyfood 0.800000 1.000 1.000

4000094000 40 Chicken, liver 0.020000 1.000 1.000

4000095000 40 Chicken, meat byproducts 0.020000 1.000 1.000

4000095001 40 Chicken, meat byproducts-babyfoo 0.020000 1.000 1.000

1500120000 15 Corn, field, flour 0.010000 1.000 1.000

1500120001 15 Corn, field, flour-babyfood 0.010000 1.000 1.000

1500121000 15 Corn, field, meal 0.010000 1.000 1.000

1500121001 15 Corn, field, meal-babyfood 0.010000 1.000 1.000

1500122000 15 Corn, field, bran 0.010000 1.000 1.000

1500123000 15 Corn, field, starch 0.010000 1.000 1.000

1500123001 15 Corn, field, starch-babyfood 0.010000 1.000 1.000

1500124000 15 Corn, field, syrup 0.010000 1.500 1.000

1500124001 15 Corn, field, syrup-babyfood 0.010000 1.500 1.000

1500125000 15 Corn, field, oil 0.010000 1.000 1.000

1500125001 15 Corn, field, oil-babyfood 0.010000 1.000 1.000

1500126000 15 Corn, pop 0.010000 1.000 1.000

1500127000 15 Corn, sweet 0.010000 1.000 1.000

1500127001 15 Corn, sweet-babyfood 0.010000 1.000 1.000

8000157000 80 Fish-freshwater finfish 0.050000 1.000 1.000

8000158000 80 Fish-freshwater finfish, farm ra 0.050000 1.000 1.000

8000159000 80 Fish-saltwater finfish, tuna 0.050000 1.000 1.000

8000160000 80 Fish-saltwater finfish, other 0.050000 1.000 1.000

8000161000 80 Fish-shellfish, crustacean 0.050000 1.000 1.000

8000162000 80 Fish-shellfish, mollusc 0.050000 1.000 1.000

3200170000 32 Goat, meat byproducts 0.800000 1.000 1.000

3200172000 32 Goat, kidney 0.800000 1.000 1.000

3200173000 32 Goat, liver 0.800000 1.000 1.000

3400292000 34 Pork, meat byproducts 0.400000 1.000 1.000

3400292001 34 Pork, meat byproducts-babyfood 0.400000 1.000 1.000

3400294000 34 Pork, kidney 0.400000 1.000 1.000

3400295000 34 Pork, liver 0.400000 1.000 1.000

6000302000 60 Poultry, other, liver 0.020000 1.000 1.000

6000303000 60 Poultry, other, meat byproducts 0.020000 1.000 1.000

3500341001 35 Sheep, fat-babyfood 0.800000 1.000 1.000

3500342000 35 Sheep, kidney 0.800000 1.000 1.000

3500343000 35 Sheep, liver 0.800000 1.000 1.000

5000383000 50 Turkey, liver 0.020000 1.000 1.000

5000383001 50 Turkey, liver-babyfood 0.020000 1.000 1.000

5000384000 50 Turkey, meat byproducts 0.020000 1.000 1.000
Topramezone Dietary Exposure and Risk Assessment DP# 400947

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5000384001 50 Turkey, meat byproducts-babyfood 0.020000 1.000 1.000

8601000000 86A Water, direct, all sources 0.045000 1.000 1.000

 Full comment: New, Tier II peak surface water 5.281 ppb

8602000000 86B Water, indirect, all sources 0.045000 1.000 1.000

 Full comment: New, Tier II peak surface water 5.281 ppb

Attachment 2: Acute (General U.S. Population) Results File.

US EPA Ver. 3.16, 03-08-d

DEEM-FCID ACUTE Analysis for TOPRAMEZONE NHANES 2003-2008 2-Day

Residue file: 123009a.R08 Adjustment factor #2 used.

Analysis Date: 02-01-2013/09:24:29 Residue file dated: 02-01-2013/09:22:48

RAC/FF intake summed over 24 hours

Run Comment: "acute "

==========================================================================

Summary calculations--per capita:

 95th Percentile 99th Percentile 99.9th Percentile

 Exposure % aRfD Exposure % aRfD Exposure % aRfD 

 ---------- -------- ---------- -------- ---------- --------

Total US Population:

 0.002541 31.77 0.004161 52.01 0.007852 98.15 

All Infants:

 0.007829 97.86 0.010436 130.45 0.015309 191.36 

Children 1-2:

 0.004041 50.52 0.005924 74.05 0.014072 175.89 

Children 3-5:

 0.003230 40.37 0.004864 60.80 0.007759 96.98 

Children 6-12:

 0.002467 30.84 0.003971 49.64 0.006076 75.95 

Youth 13-19:

 0.002098 26.23 0.003431 42.89 0.005127 64.09 

Adults 20-49:

 0.002469 30.86 0.003632 45.41 0.005314 66.43 

Adults 50-99:

 0.002205 27.57 0.003351 41.89 0.005152 64.41 
Topramezone Dietary Exposure and Risk Assessment DP# 400947

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Attachment 3: Acute (Females 13-49 years old) Results File.

US EPA Ver. 3.16, 03-08-d

DEEM-FCID ACUTE Analysis for TOPRAMEZONE NHANES 2003-2008 2-Day

Residue file: 123009a.R08 Adjustment factor #2 used.

Analysis Date: 02-01-2013/09:26:38 Residue file dated: 02-01-2013/09:22:48

RAC/FF intake summed over 24 hours Run Comment: "acute "

==========================================================================

Summary calculations--per capita:

 95th Percentile 99th Percentile 99.9th Percentile

 Exposure % aRfD Exposure % aRfD Exposure % aRfD 

 ---------- -------- ---------- -------- ---------- --------

Female 13-49:

 0.002508 50.16 0.003633 72.65 0.005068 101.35 
Topramezone Dietary Exposure and Risk Assessment DP# 400947

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Attachment 4: Chronic Food + Drinking Water Residue Input File.

US EPA Ver. 3.16, 03-08-d

DEEM-FCID Chronic analysis for TOPRAMEZONE

Residue file: C:\Documents and 

Settings\slevy\Desktop\Topramezone\123009ctest45.R08 

Adjust. #2 used

Analysis Date 02-01-2013 Residue file dated: 02-01-2013/08:35:35

Reference dose (RfD) = 0.004 mg/kg bw/day Comment:chronic

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Food Crop Residue Adj.Factors

EPA Code Grp Food Name (ppm) #1 #2 

---------- ---- --------------------------- ---------- ------ ------

3100046000 31 Beef, meat byproducts 0.800000 1.000 1.000 

3100046001 31 Beef, meat byproducts-babyfood 0.800000 1.000 1.000 

3100048000 31 Beef, kidney 0.800000 1.000 1.000 

3100049000 31 Beef, liver 0.800000 1.000 1.000 

3100049001 31 Beef, liver-babyfood 0.800000 1.000 1.000 

4000094000 40 Chicken, liver 0.020000 1.000 1.000 

4000095000 40 Chicken, meat byproducts 0.020000 1.000 1.000 

4000095001 40 Chicken, meat byproducts-babyfo0.020000 1.000 1.000 

1500120000 15 Corn, field, flour 0.010000 1.000 1.000 

1500120001 15 Corn, field, flour-babyfood 0.010000 1.000 1.000 

1500121000 15 Corn, field, meal 0.010000 1.000 1.000 

1500121001 15 Corn, field, meal-babyfood 0.010000 1.000 1.000 

1500122000 15 Corn, field, bran 0.010000 1.000 1.000 

1500123000 15 Corn, field, starch 0.010000 1.000 1.000 

1500123001 15 Corn, field, starch-babyfood 0.010000 1.000 1.000 

1500124000 15 Corn, field, syrup 0.010000 1.500 1.000 

1500124001 15 Corn, field, syrup-babyfood 0.010000 1.500 1.000 

1500125000 15 Corn, field, oil 0.010000 1.000 1.000 

1500125001 15 Corn, field, oil-babyfood 0.010000 1.000 1.000 

1500126000 15 Corn, pop 0.010000 1.000 1.000 

1500127000 15 Corn, sweet 0.010000 1.000 1.000 

1500127001 15 Corn, sweet-babyfood 0.010000 1.000 1.000 

8000157000 80 Fish-freshwater finfish 0.050000 1.000 1.000 

8000158000 80 Fish-freshwater finfish,farmra 0.050000 1.000 1.000 

8000159000 80 Fish-saltwater finfish, tuna 0.050000 1.000 1.000 

8000160000 80 Fish-saltwater finfish, other 0.050000 1.000 1.000 

8000161000 80 Fish-shellfish, crustacean 0.050000 1.000 1.000 

8000162000 80 Fish-shellfish, mollusc 0.050000 1.000 1.000 

3200170000 32 Goat, meat byproducts 0.800000 1.000 1.000 

3200172000 32 Goat, kidney 0.800000 1.000 1.000 

3200173000 32 Goat, liver 0.800000 1.000 1.000 

3400292000 34 Pork, meat byproducts 0.400000 1.000 1.000 

3400292001 34 Pork, meat byproducts-babyfood 0.400000 1.000 1.000 

3400294000 34 Pork, kidney 0.400000 1.000 1.000 

3400295000 34 Pork, liver 0.400000 1.000 1.000 

6000302000 60 Poultry, other, liver 0.020000 1.000 1.000 

6000303000 60 Poultry, other, meat byproducts0.020000 1.000 1.000 

3500341001 35 Sheep, fat-babyfood 0.800000 1.000 1.000 

3500342000 35 Sheep, kidney 0.800000 1.000 1.000 

3500343000 35 Sheep, liver 0.800000 1.000 1.000 

5000383000 50 Turkey, liver 0.020000 1.000 1.000 

5000383001 50 Turkey, liver-babyfood 0.020000 1.000 1.000 

5000384000 50 Turkey, meat byproducts 0.020000 1.000 1.000 

5000384001 50 Turkey, meat byproducts-babyfoo0.020000 1.000 1.000 
Topramezone Dietary Exposure and Risk Assessment DP# 400947

Page 13 of 13

8601000000 86A Water, direct, all sources 0.045000 1.000 1.000 

8602000000 86B Water, indirect, all sources 0.045000 1.000 1.000 

Attachment 5: Chronic Results File.

US EPA Ver. 3.16, 03-08-d

DEEM-FCID Chronic analysis for TOPRAMEZONE NHANES 2003-2008 2-day

Residue file name: C:\Documents and 

Settings\slevy\Desktop\Topramezone\123009ctest45.R08

 Adjustment factor #2 used.

Analysis Date 02-01-2013/09:06:31 Residue file dated: 02-01-2013/08:35:35

Reference dose (RfD, Chronic) = .004 mg/kg bw/day

COMMENT 1: chronic

==========================================================================

 Total exposure by population subgroup

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 Total Exposure

 -----------------------------------

 Population mg/kg Percent of 

 Subgroup body wt/day Rfd 

----------------------------------- ------------- ----------------

Total US Population 0.000998 24.9%

All Infants 0.002487 62.2%

Children 1-2 0.001487 37.2%

Children 3-5 0.001263 31.6%

Children 6-12 0.000913 22.8%

Youth 13-19 0.000738 18.5%

Adults 20-49 0.000989 24.7%

Adults 50-99 0.000971 24.3%

Female 13-49 0.000978 24.5%

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