Topramezone Die t ary Exposure and Ri sk Assessment UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D.C. 20460 DP # 400947

OFFICE OF CHEMICAL SAFETY AND POLLUTIO N PREVENTION



### MEMORAN D UM
Da t e : 15-MA Y-2013
SUBJEC T : Topra m ez on e. Acute and Chronic Agg r egate Di etary (Food and Drink in g Water) Exposure an d R isk Assessments f or t h e S e ct i on 3 Registra t ion Act i o n Concerning No n- cr op Aqu a t ic App li cati on.
PC Co de : 123009 DP Bar c o de : D400947 Dec i sion No

. : 462026 Registr atio n No.: 7969-XXX Pe ti t i on No .: 2F7997 Reg ul a to ry A c ti o n: Section 3 Registration R i sk Assess ment Ty p e: Dietary Case N o
. : 7268 TXR No .: N /A CAS No

. : 210631-68-8 MRID N o. : N/A 40 CFR: §1 8 0.612
FROM : Sara h 

### J

. Le v y , Che m is t 

# M (}**~** 

# / '

Risk Assessment Br anc h l (RAB 0/He:i"t{ Effec t s Di vision (HED; 750 9P )
THROUGH : Nancy Dodd, Chemist

### ~~ Ideliz Negro n-Encarnacion , Chemist 

# ;?1(1 

# L-- D ietary Ex posure Science Advisory CounciY(D E SAC)/HED (7509 P )
and
Geo r ge F. Kramer, P h .D ., Branc h Se n io r Sci enti s t RAB l ll

- IED (7509 P )
TO : Chester Rodriguez, Ph.D

. , Pharmacologist RAB 1/H E D (7509 P )
and Kathryn Mo n tague/Bethany Benbow (RM 23) Reg i stration Di visi on ( RD ; 7505P)

P age I of 13Topramezone Dietary Exposure and Risk Assessment DP # 400947 Executive Summary
Unrefined acute and chronic aggregate dietary (food + d rinki ng wat er ) exposure and risk assessments were conducted for topramezone ([3-(4,5-dihydro-3-isoxazoly l )-2-methyl-4- ( me thy lsu lfony 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 Na tiona l 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 fo r th e non-crop aquatic application oftopramezone and proposed tolerances for re sidues oftoprarnezone per se inion fish and s hell fish at 0.05 ppm. The unrefined acute and chronic analyses assumed tole rancelevel residues, 100 % crop treated (CT), D EEM (ver. 7.81) default processing factors, and modeled drinking water numbers.
These analyses have been reviewed by two peer rev iewe rs of the DESAC, per the DESAC Standard Operating Pro cedure (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) iden tified: one fo r the ge n e r a l U.S. population ( includin g infants and children) and one for females 13-49 years of age. Both unrefined acute analyses assumed 100% C T , DEEM 7.81 defaul t processing factors, and tolerance-level residues. Drinking water numbers were incorpora t ed directly into the acute dietary assessments. The estimated drink i ng water concentrations (EDWCs) were based on the proposed use fo r water bodies with functiona l potable water intakes, which cannot exceed 45 ppb.
The acute dietary exposure and risk estimates (food+ drinking water) were est im ated at 0.002541 mg/kg/day for th e general U.S

. popu lati on ((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 (a ll infants <1 year old) and are th u s below HED's level of concern (<100% aPAD). The resulting acute dietary exposure and risk estimates using the DEEM-FCID model at the 95 111 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 Wa t er) Exposure Results and Characterization
The chronic analysis assumed 100% CT, DEEM 7.81 default processing factors, and tolerancel evel residues. E DWCs were incorporated directly into the chronic dietary assessments. T he resulting chronic (food + drinking water) risk estimates were les s than HED ' s LOC ( < 1 00% of the chronic population -adj usted dose ( cPAD)) for the general U.S

. popu lati on (25% of the cP AD) and all population subgroups. The most highly exposed population subgroup was a ll infants (<1 year old) with an estimated exposure equivalent to 62% of the cPAD ; therefore, th e chronic dietary exposure to topramezone is below HED 's l evel of concern.
A chronic cancer dietary assessment was not conducted since it was determined that toprarnezone i s not likely to be a human carcinogen.

Page 2 of 13Topramezone Dietary Exposure and Risk Assessment DP# 400947

Page 3 of 13 

### 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.) divide d 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 availabl e 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 submit ted a poultry feedin g 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 re sidues 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 conclude d 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: T opramezone is a broad

- spectrum systemic herbicide which in hibits 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, residentia l 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

- 201 3 ; D 400949 ) . A revised Section F should be submitted whic h specifies the new tolerance expression and the HED recommended commodity definitions and tolerance levels. With the establishment of the tolerances indicatedTopramezone Dietary Exposure and Risk Assessment DP# 400947

Page 4 of 13 

### 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 t olerance levels is to be determined by measuring only topramezone ([3

- (4,5

- dihydro

- 3

- isoxazolyl)

- 2

- methyl

- 4

- (methylsulfonyl)phenyl](5

- hydroxy

- 1

- methyl

- 1 H

- 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. Estimate d 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 t opramezone 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 th e 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 consum ption 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) u sing 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 retainedTopramezone Dietary Exposure and Risk Assessment DP# 400947

Page 5 of 13 

### 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 f ollowing 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 food

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 in take 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 percen t 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 no t) 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 specif ically identified and noted in the risk assessment.
VI. Toxicological Information
Table 2 is a summary of the toxicolog ical doses and endpoints selected that are relevant to dietary risk assessment ( Memo, K. Lowe, 02

- FEB

- 2012; D388367)

.
Table 2
. Toxicolog ical Doses and Endpoints for Topramezone for Use in Dietary Risk Assessment s . 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 intra

species 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 intra

species extrapolation) FQPA SF= 1X aRfD = aPAD = 0.005 mg/kg/day Developmental Toxicity Stud y 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 intra

species 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 andTopramezone Dietary Exposure and Risk Assessment DP# 400947

Page 6 of 13 Table 2
. Toxicolog ical Doses and Endpoints for Topramezone for Use in Dietary Risk Assessment s . 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 non

cancer risk assessment is not expected to alter thyroid hormo ne 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

- ob served 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 subgrou ps. 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 pea k concentration for surfac e water generated by the PRZM

- EXAMS model. The acute dietary exposure and risk estimates (food + drinking water) were estimated at 0.00 2544 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 95 th 

### percentile of exposure, as all inputs were unrefined. The resulting acute dietary exposure and risk estimate using the DEEM

- FCID model at the 95 th 

### percentile for females 13

- 49 years of age was 0.002508 mg/kg/day (50% of the aPAD) and is belo w HED’s level of concern (<100% aPAD). Acute dietary exposure to topramezone is below HED ’s level of concern for all population s
. Chronic Dietary (Food + Drinking Water) Exposure Results and Characterization The chronic analysis assumed 100% CT, DEEM 7.81 default processing factors, and tolerance

level 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 6 2 % ofTopramezone Dietary Exposure and Risk Assessment DP# 400947

Page 7 of 13 

### the cPAD. Therefore, the chronic dietary exposure to topramezone is not of concern to HED. A chr onic 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 Subgroup 1 Acute Dietary 2 (95 Percentile) Chronic Dietary 3 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. 0078 29 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 proce ssing factors. The resulting acute and chronic aggregate risk estimates a re below HED’s LOC. HED is confident that the assessments do no t underestimate risk to the general U.S. population or any population subgroup.Topramezone Dietary Exposure and Risk Assessment DP# 400947

Page 8 of 13 

### 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: Ch ronic Results File.

RDI: DESAC ( 30

- JAN

- 201 3 ); G.F. Kramer ( 3 1

- JAN

- 201 3 ) S. Levy:S10953:PY1:(703)305

- 0783:7590PTopramezone Dietary Exposure and Risk Assessment DP# 400947

Page 9 of 13 

### 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, fl our - 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 Co rn, 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 80001 58000 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, crus tacean 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, k idney 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 1.000Topramezone Dietary Exposure and Risk Assessment DP# 400947

Page 10 of 13 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, indi rect, 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 Exposu re % 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: 0.00246 7 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 64.41Topramezone Dietary Exposure and Risk Assessment DP# 400947

Page 11 of 13 

### 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 101.35Topramezone Dietary Exposure and Risk Assessment DP# 400947

Page 12 of 13 

### 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 S ettings \ 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

-------------------------------------------------------------------------- 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 byproduc ts

- 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 1500 123001 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, fiel d, 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 Poultr y, 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 1.000Topramezone 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 \ Topramezo ne \ 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

-------------------------------------------------------------------------- Total Exposu re

----------------------------------- 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%

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