UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

MEMORANDUM 

December 6, 2013 

OFFICE OF CHEMICAL SAFETY AND 

POLLUTION PREVENTION 

SUBJECT: Clomazooe. Acute and Chronic Aggregate Dietary (Food and Drinking Water) 

Exposure and Risk Assessments for Proposed New Uses on Brassica, Head and 

Stem (Subgroup SA), Rhubarb and Southern Pea. 

PC Code: 125401 DP Barcode: D410437 

Decision No.: 473594 Registration No.: 279-31S8 

Petition No.: 2E8136 Regulatory Action: Amended Section 3 Registration 

Risk Assessment Type: Dietary Case No.: 7203 

TXR No.: NA CAS No.: 81777-89-1 

MRID No.: NA 40 CFR: §180.42S 

FROM: Bonnie Cropp-Kohlligian, Environmental Scientis~ ~ -~\0 Risk Assessment Branch IV (RABIV) ~ Health Effects Division (HED) (7S09P) 

THROUGH: Thurston Morton, Chemist, Senior Scientist 

RABJV, HED (7S09P) 

and n 

Douglas A. Dotson, Ph.D., Chemist ~ · ~)~ Kristin Rury, Biologist 'f Q---x 

Dietary Exposure Science Advisory ~cil (DESAC), HED (7S09P) 

TO: Sidney Jackson/Barbara Madden, PMOS 

Risk Integration Minor Use Emergency Response Branch 

Registration Division (7SOSP) 

Executive Summary 

Acute and chronic aggregate dietary (food and drinking water) exposure and risk assessments 

were conducted using the Dietary Exposure Evaluation Model software with the Food 

Commodity Intake Database (DEEM-FCID) Version 3.16. This software uses 2003-2008 food 

consumption data from the U.S. Department of Agriculture's (USDA's) National Health and 

Nutrition Examination Survey, What We Eat in America, (NHANES/WWEIA). The analyses 

Page 1 of 12 
C1omazone ( 125401) Dietary Exposure and Risk Assessment DP Number: 410437 

were conducted in support of a human health risk assessment for the proposed Section 3 uses of 

clomazone on Brassica, head and stem (Subgroup SA), rhubarb, and southern pea. This 

memorandum was reviewed by two peer reviewers of the DESAC, per DESAC SOP 2012.1. 

Both the acute and chronic assessments are highly conservative and incorporated tolerance level 

residues, assumed 100% crop treated and used default processing factors. Screening-level Tier I 

modeling was used to estimate drinking water concentrations. 

The acute dietary risk estimate at the 951h percentile of exposure utilized 3.0% of the acute 

population adjusted dose (aPAD) for females 13-49 years old. This is the only population 

subgroup for which an acute endpoint was selected. The acute dietary risk estimate for females 

13-49 years old is not of concern. 

The chronic dietary risk estimates are :53.6% of the chronic population adjusted dose (cPAD) for 

all population subgroups. All Infants < 1 year of age is the most highly exposed subgroup, 

utilizing 3.6% ofthe cPAD, while the general US population utilizes 1.4% of the cPAD. The 

chronic dietary risk estimates are not of concern. 

Clomazone is not likely to be carcinogenic to humans; hence, a cancer exposure and risk 

assessment was not conducted. 

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 that HED has concluded will result in no unreasonable adverse health effects). 

This dose is referred to as the population adjusted dose (PAD). The PAD is equivalent to the 

point of departure (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% ofthe PAD. References that 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-12/606 I.pdf; or see SOP 99.6 (20-AUG1999). 

The most recent dietary risk assessment for clomazone (food only) was conducted by S. Levy 

( 4/26/02, DP# 282390). 

II. Residue Information 

Plants: Based on metabolism studies on soybeans, com, cotton, sweet potatoes, tomatoes and 

bell peppers, and alfalfa, HED concludes that the nature of the residue in plants is adequately 

understood. The major metabolite was 2-chlorobenzyl alcohol. The postulated major route of 

metabolism of clomazone in plants is hydroxylation of the methylene bridge carbon of 

Page 2 of 12 
Clomazone (125401) Dietary Exposure and Risk Assessment DP Number: 410437

Page 3 of 12

clomazone to form the unstable intermediate, carbinolamide; which decomposes to form the 

isoxazolidinone moiety and 2-chlorobenzaldehyde. 2-chlorobenzaldehyde reduces to the alcohol 

or is oxidized to the carboxylic acid. The alcohol, the carboxylic acid, and the isoxazolidinone 

metabolites form glycosides and/or amino acid conjugates. Minor pathways include 

hydroxylation of clomazone to form monohydroxylated and possibly dihydroxylated metabolites. 

Based on low levels of these metabolites found in crops, the HED risk assessment team has 

determined that the residue of concern for regulatory and risk assessment purposes in plants is 

parent only.

Permanent tolerances for residues of clomazone are established under 40 CFR §180.425 for a 

number of plant commodities. Compliance with the tolerance levels is to be determined by 

measuring only the parent. The current dietary analyses are based on the 

established/recommended tolerances for residues of clomazone which are listed below in 

Table 1.

Table 1. Tolerance Summary for Clomazone.

Commodity

Established

Tolerance

(ppm)

Recommended 

Tolerance Under 

Current Petition

(ppm)

Comments

Bean, snap, succulent 0.05 --

Brassica, head and stem, subgroup 5A -- 0.10

Cabbage 0.1 Revoke

Cotton, undelinted seed 0.05 --

Cowpea, forage -- 0.05

Cowpea, hay -- 0.05

Cucumber 0.1 --

Pea, southern, succulent seed -- 0.05 Other common names for 

Southern pea include Cowpea 

and Black-eyed pea. 

Pea, southern, dry seed -- 0.05

Pea, succulent 0.05 --

Pepper 0.05 --

Peppermint, tops 0.05 --

Pumpkin 0.1 --

Rice, grain 0.02 --

Rice, straw 0.02 --

Rhubarb -- 0.30

Soybean 0.05 --

Spearmint, tops 0.05 --

Squash, summer 0.1 --

Squash, winter 0.1 --

Sugarcane, cane 0.05 --

Sweet potato, roots 0.05 --

Vegetable, cucurbit, group 9 0.05 --

Vegetable, tuberous and corm, except 

potato, subgroup 1D

0.05 --

Livestock: HED has determined that there is no reasonable expectation of finite residues of 

concern in livestock commodities.
Clomazone (125401) Dietary Exposure and Risk Assessment DP Number: 410437

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Drinking Water: A major degradate in the anaerobic aquatic metabolism study was FMC65317 

(N-[(2-chlorophenyl)methyl]-3-hydroxy-2,2-dimenthylpropanamide), observed at up to 100x the 

parent concentration after 120 days in the anaerobic aquatic metabolism study. In the aerobic 

aquatic study it reached only 11% of parent at one sampling interval. Based on these data, an ad

hoc HED MARC (Metabolism Assessment Review Committee; D268905; 10/2/00) determined 

that the parent and its degradate, FMC65317, are residues of concern in drinking water.

Fish: No tolerances are currently established for residues of clomazone in fish. The USDA 

Pesticide Data Program (PDP) monitored pesticide residues in catfish in 2008, 2009, and 2010. 

Over this 3-year period, PDP analyzed 1479 samples of catfish for clomazone residues. None of 

the samples contained detectable residues. As a result, residues in fish were not included in the 

assessment.

III. Percent Crop Treated Information

The acute and chronic assessments are based on the assumption that 100% of all commodities 

with tolerances will be treated.

IV. Drinking Water Data

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

Environmental Fate and Effects Division (EFED) in the following memoranda: “Clomazone: 

Drinking Water Exposure Assessment for Proposed New Uses for Brassica (Head and Stem 

Subgroup 5A), Southern Peas, and Rhubarb” (Both memoranda under D408878 by J. Lin and 

dated 7/23/13 or 9/24/13). These estimated drinking water concentrations (EDWCs) were 

incorporated directly into this dietary assessment in the DEEM-FCID into the food categories 

“water, direct, all sources” and “water, indirect, all sources.” 

EFED generated the surface water EDWCs using FQPA Index Reservoir Screening Tool

(FIRST) and the Tier 1 Rice model. Ground water EDWCs were generated using Pesticide Root 

Zone Model for Ground Water (PRZM-GW) and Screening Concentration In GROund Water

(SCI-GROW). EDWCs were derived based on the maximum registered/proposed use rate (1.5 

lb ai/A existing for tuberous and corm vegetables and proposed for rhubarb) and the maximum 

registered use rate on rice (dry-seeded 0.8 lb ai/A). The Tier 1 Rice model (dry-seeded scenario) 

produced the highest EDWCs for both acute and chronic at 550 ppb and this estimate was used 

in both the acute and chronic dietary risk assessments. 
Clomazone (125401) Dietary Exposure and Risk Assessment DP Number: 410437

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Table 2. EDWCs for the Clomazone Human Health Risk Assessment 

Source (Tier: Model) Maximum Annual Rate Acute

EDWC

(μg/L)

Chronic

EDWC

(μg/L)

Surface Water (Tier 1: FIRST) 1.5 lb ai/A 89.2 12.8

Surface Water (Tier 1: Rice Model)10.8 lb ai/A

(dry-seeded scenario)2 550

Ground Water (Tier 1: PRZM-GW) 1.5 lb ai/A 85.7 77.4

Ground Water (Tier 1: SCI-GROW) 1.5 lb ai/A 0.0338

1

 Calculates the water-column exposure expected on the day of application to a flooded rice paddy, accounting only 

for sorption to sediment as a dissipation process. No other degradation processes, such as hydrolysis, photolysis, or 

metabolism are considered. Hence, this exposure modeling is inclusive of all of the residues of concern (parent plus 

FMC 65317). 

2

 Clomazone used in dry-seeded rice culture is subject to dissipation (volatilization and aerobic metabolism) after 

application but prior to flooding; however, significant levels of the metabolite FMC 65317 are not expected to form 

during this interval under these aerobic conditions. The potential dissipation of the parent after application but prior 

to flooding was accounted for in the calculated concentration/use rate for clomazone (0.707 lb ai/A) used in the Tier 

1 Rice Model. [Reviewer Note: The maximum registered use rate for clomazone on wet-seeded rice (0.6 lb ai/A) is 

less than that used in the Tier 1 Rice Model.] 

The drinking water models and their descriptions are available at the EPA internet site: 

http://www.epa.gov/oppefed1/models/water/. 

V. DEEM-FCID Program and Consumption Information

Clomazone acute and chronic dietary exposure assessments were conducted using the DEEMFCID, Version 3.16, which incorporates 2003-2008 consumption data from USDA’s 

NHANES/WWEIA. 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 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 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 
Clomazone (125401) Dietary Exposure and Risk Assessment DP Number: 410437

Page 6 of 12

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.

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.

VI. Toxicological Information

An acute reference dose (aRfD) of 1.0 mg/kg/day was established for females 13-50 years old 

based on a developmental no observed adverse effect level (NOAEL) of 100 mg/kg/day from a 

developmental toxicity study in the rat. The Food Quality Protection Act (FQPA) Safety Factor 

(SF) of 1X is applicable for acute dietary risk assessment. The acute population adjusted dose

(aPAD) is equivalent to the aRfD of 1.0 mg/kg/day. An aRfD was not established for the U.S. 

general population, including infants and children, because a dose and endpoint attributable to a 

single exposure were not identified from the available oral toxicity studies, including maternal 

toxicity in the developmental toxicity studies.

The chronic reference dose (cRfD) of 0.84 mg/kg/day was determined on the basis of a 2-year 

combined toxicity/carcinogenicity study in rats, a 90-day oral toxicity study in rats, and a 2-

generation reproduction toxicity study in rats. The NOAEL of 84.4 mg/kg/day (HDT) from the 

2-year chronic toxicity/carcinogenicity rat study was selected. The FQPA SF of 1X is applicable 

for chronic dietary risk assessment. The chronic population adjusted dose (cPAD) is equivalent 

to the cRfD of 0.84 mg/kg/day.

The HIARC classified clomazone as a "not likely human carcinogen" based on the lack of a 

carcinogenic response in rats and mice and the lack of mutagenic concern. Therefore, a cancer 

risk assessment is not required for this action.

HED evaluated the toxicology data base for clomazone and selected doses and endpoints for 

dietary risk assessments provided in Table 3.
Clomazone (125401) Dietary Exposure and Risk Assessment DP Number: 410437

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Table 3. Toxicological Doses and Endpoints for Clomazone for Use in Dietary Health Risk Assessments.

Exposure/

Scenario

Point of 

Departure

Uncertainty/

FQPA Safety 

Factors

RfD & PAD Study and Toxicological Effects

Acute Dietary 

(General 

population)

A dose and endpoint were not selected for this population group because there were no effects observed in 

oral toxicology studies including maternal toxicity in the developmental toxicity studies in rats and rabbits 

that are attributable to a single exposure (dose). A risk assessment is not required for this population 

subgroup.

Acute Dietary 

(Females 13-

50 years of 

age)

NOAEL= 100 

mg/kg/day

UFA=10x

UFH=10x

FQPA SF = 1x

Acute RfD = 1.0 

mg/kg/day

aPAD = 1.0 

mg/kg/day

Developmental toxicity rat

Developmental LOAEL = 300 mg/kg/day, 

based on delayed ossification.

Chronic 

Dietary (All 

Populations)

NOAEL = 84.4 

mg/kg/day

UFA=10x

UFH=10x

FQPA SF = 1x

Chronic RfD = 0.84 

mg/kg/day

cPAD = 0.84 

mg/kg/day

Two year combined 

toxicity/carcinogenicity rat

LOAEL > 84.4 mg/kg/day (HDT)

90-Day oral toxicity rat

LOAEL = 319.3 mg/kg/day based on 

based on decreased body weight, body 

weight gains, food consumption and 

increased absolute and relative liver 

weights in females and increased absolute 

liver weights in males.

2-Generation reproduction toxicity rat

LOAEL = 100 mg/kg/day based on 

statistically significantly decreased body 

wt. & body wt. gain during pre-mating, 

and decreased body wt. during gestation & 

lactation M & F. In addition decreased 

food consumption in females and hydronephritic kidneys in males.

Cancer (all 

routes)

Classification: Not likely human carcinogen based on the lack of a carcinogenic response in rats and mice 

and the lack of mutagenic concern. 

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. 

UFA = extrapolation from animal to human (interspecies). 

UFH = potential variation in sensitivity among members of the human population (intraspecies). 

FQPA SF = FQPA Safety Factor. 

PAD = population adjusted dose (a = acute, c = chronic). 

RfD = reference dose. 

II. Results/Discussion 

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

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

population and various subgroups including 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. The acute and chronic dietary exposure analyses are reported in Table 4.
Clomazone (125401) Dietary Exposure and Risk Assessment DP Number: 410437

Page 8 of 12

Table 4. Summary of Dietary (Food and Drinking Water) Exposure and Risk for Clomazone.

Population Subgroup

Acute Dietary

(95th Percentile) Chronic Dietary Cancer

Dietary 

Exposure 

(mg/kg/day)

% aPAD*

Dietary 

Exposure

(mg/kg/day)

% cPAD*

Dietary 

Exposure

(mg/kg/day)

Risk

General U.S. Population

N/A N/A

0.011624 1.4

All Infants (<1 year old) 0.029942 3.6

N/A N/A

Children 1-2 years old 0.016899 2.0

Children 3-5 years old 0.014233 1.7

Children 6-12 years old 0.010243 1.2

Youth 13-19 years old 0.008475 1.0

Adults 20-49 years old 0.011576 1.4

Adults 50-99 years old 0.011451 1.4

Females 13-49 years old 0.030050 3.0 0.011536 1.4

VIII. Characterization of Inputs/Outputs

The acute and chronic dietary exposure and risk analyses are based on tolerance-level residues, 

100% crop treated assumptions, and default processing factors. Various refinements could be 

made to the assessments. However, as there are no risk estimates of concern, no refinements 

were incorporated.

IX. Conclusions

A conservative acute dietary exposure analysis was performed for Females age 13-49; the only 

population subgroup for which an acute endpoint was selected. A conservative chronic dietary 

exposure analysis was performed for the general U.S. population and various population 

subgroups. The acute and chronic risk estimates are not of concern. HED is confident the acute 

and chronic dietary exposures to clomazone are not underestimated.

X. List of Attachments

Attachment 1. Acute/Chronic Residue Input File for Clomazone.

Attachment 2. Summary of the Acute Dietary Exposure and Risk Estimates for Clomazone.

Attachment 3. Summary of the Chronic Dietary Exposure and Risk Estimates for Clomazone. 
Clomazone (125401) Dietary Exposure and Risk Assessment DP Number: 410437

Page 9 of 12

Attachment 1. Acute/Chronic Residue Input File for Clomazone.

Filename: Clomazone.r08

Chemical: Clomazone

RfD(Chronic): .84 mg/kg bw/day NOEL(Chronic): 84 mg/kg bw/day

RfD(Acute): 1 mg/kg bw/day NOEL(Acute): 100 mg/kg bw/day

Date created/last modified: 09-11-2013/14:07:33 Program ver. 3.16, 03-08-d

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

 EPA Crop Def Res Adj.Factors Comment

 Code Grp Commodity Name (ppm) #1 #2 

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

0103015000 1CD Arrowroot, flour 0.050000 1.000 1.000 

0103015001 1CD Arrowroot, flour-babyfood 0.050000 1.000 1.000 

0103017000 1CD Artichoke, Jerusalem 0.050000 1.000 1.000 

0103082000 1CD Cassava 0.050000 1.000 1.000 

0103082001 1CD Cassava-babyfood 0.050000 1.000 1.000 

0103139000 1CD Dasheen, corm 0.050000 1.000 1.000 

0103166000 1CD Ginger 0.050000 1.000 1.000 

0103166001 1CD Ginger-babyfood 0.050000 1.000 1.000 

0103167000 1CD Ginger, dried 0.050000 1.000 1.000 

0103366000 1CD Sweet potato 0.050000 1.000 1.000 

0103366001 1CD Sweet potato-babyfood 0.050000 1.000 1.000 

0103371000 1CD Tanier, corm 0.050000 1.000 1.000 

0103387000 1CD Turmeric 0.050000 1.000 1.000 

0103406000 1CD Yam, true 0.050000 1.000 1.000 

0103407000 1CD Yam bean 0.050000 1.000 1.000 

0402322000 4B Rhubarb 0.300000 1.000 1.000 

0501061000 5A Broccoli 0.100000 1.000 1.000 

0501061001 5A Broccoli-babyfood 0.100000 1.000 1.000 

0501062000 5A Broccoli, Chinese 0.100000 1.000 1.000 

0501064000 5A Brussels sprouts 0.100000 1.000 1.000 

0501069000 5A Cabbage 0.100000 1.000 1.000 

0501071000 5A Cabbage, Chinese, napa 0.100000 1.000 1.000 

0501072000 5A Cabbage, Chinese, mustard 0.100000 1.000 1.000 

0501083000 5A Cauliflower 0.100000 1.000 1.000 

0501196000 5A Kohlrabi 0.100000 1.000 1.000 

0600347000 6 Soybean, seed 0.050000 1.000 1.000 

0600349000 6 Soybean, soy milk 0.050000 1.000 1.000 

0600349001 6 Soybean, soy milk-babyfood or in 0.050000 1.000 1.000 

0600350000 6 Soybean, oil 0.050000 1.000 1.000 

0600350001 6 Soybean, oil-babyfood 0.050000 1.000 1.000 

0601043000 6A Bean, snap, succulent 0.050000 1.000 1.000 

0601043001 6A Bean, snap, succulent-babyfood 0.050000 1.000 1.000 

0601257000 6A Pea, edible podded, succulent 0.050000 1.000 1.000 

0602033000 6B Bean, cowpea, succulent 0.050000 1.000 1.000 

0602255000 6B Pea, succulent 0.050000 1.000 1.000 

0602255001 6B Pea, succulent-babyfood 0.050000 1.000 1.000 

0602259000 6B Pea, pigeon, succulent 0.050000 1.000 1.000 

0603034000 6C Bean, cowpea, seed 0.050000 1.000 1.000 

0603348000 6C Soybean, flour 0.050000 1.000 1.000 

0603348001 6C Soybean, flour-babyfood 0.050000 1.000 1.000 

0802270000 8B Pepper, bell 0.050000 1.000 1.000 

0802270001 8B Pepper, bell-babyfood 0.050000 1.000 1.000 

0802271000 8B Pepper, bell, dried 0.050000 1.000 1.000 

0802271001 8B Pepper, bell, dried-babyfood 0.050000 1.000 1.000 

0802272000 8BC Pepper, nonbell 0.050000 1.000 1.000 

0802272001 8BC Pepper, nonbell-babyfood 0.050000 1.000 1.000 

0802273000 8BC Pepper, nonbell, dried 0.050000 1.000 1.000 

0901075000 9A Cantaloupe 0.050000 1.000 1.000 

0901187000 9A Honeydew melon 0.050000 1.000 1.000 

0901399000 9A Watermelon 0.050000 1.000 1.000 

0901400000 9A Watermelon, juice 0.050000 1.000 1.000 

0902021000 9B Balsam pear 0.050000 1.000 1.000 

0902088000 9B Chayote, fruit 0.050000 1.000 1.000 

0902102000 9B Chinese waxgourd 0.050000 1.000 1.000 

0902135000 9B Cucumber 0.100000 1.000 1.000 

0902308000 9B Pumpkin 0.100000 1.000 1.000 

0902309000 9B Pumpkin, seed 0.100000 1.000 1.000 

0902356000 9B Squash, summer 0.100000 1.000 1.000 

0902356001 9B Squash, summer-babyfood 0.100000 1.000 1.000 

0902357000 9B Squash, winter 0.100000 1.000 1.000 
Clomazone (125401) Dietary Exposure and Risk Assessment DP Number: 410437

Page 10 of 12

0902357001 9B Squash, winter-babyfood 0.100000 1.000 1.000 

1500323000 15 Rice, white 0.020000 1.000 1.000 

1500323001 15 Rice, white-babyfood 0.020000 1.000 1.000 

1500324000 15 Rice, brown 0.020000 1.000 1.000 

1500324001 15 Rice, brown-babyfood 0.020000 1.000 1.000 

1500325000 15 Rice, flour 0.020000 1.000 1.000 

1500325001 15 Rice, flour-babyfood 0.020000 1.000 1.000 

1500326000 15 Rice, bran 0.020000 1.000 1.000 

1500326001 15 Rice, bran-babyfood 0.020000 1.000 1.000 

2003128000 20C Cottonseed, oil 0.050000 1.000 1.000 

2003128001 20C Cottonseed, oil-babyfood 0.050000 1.000 1.000 

8601000000 86A Water, direct, all sources 0.550000 1.000 1.000 

8602000000 86B Water, indirect, all sources 0.550000 1.000 1.000 

9500275000 O Peppermint 0.050000 1.000 1.000 

9500276000 O Peppermint, oil 0.050000 1.000 1.000 

9500352000 O Spearmint 0.050000 1.000 1.000 

9500353000 O Spearmint, oil 0.050000 1.000 1.000 

9500362000 O Sugarcane, sugar 0.050000 1.000 1.000 

9500362001 O Sugarcane, sugar-babyfood 0.050000 1.000 1.000 

9500363000 O Sugarcane, molasses 0.050000 1.000 1.000 

9500363001 O Sugarcane, molasses-babyfood 0.050000 1.000 1.000 
Clomazone (125401) Dietary Exposure and Risk Assessment DP Number: 410437

Page 11 of 12

Attachment 2. Summary of the Acute Dietary Exposure and Risk Estimates for Clomazone.

U.S. EPA Ver. 3.16, 03-08-d

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

Residue file: Clomazone.r08 Adjustment factor #2 not used.

Analysis Date: 10-23-2013/15:34:17 Residue file dated: 10-23-2013/15:31:25

NOEL (Acute) = 100.000000 mg/kg body-wt/day

Reference dose (RfD, Acute) = 1.0 mg/kg bw/day

RAC/FF intake summed over 24 hours

Run Comment: ""

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

Summary calculations--per capita:

--- 95th Percentile---- --- 99th Percentile---- ---99.9th Percentile----

Exposure % aRfD MOE Exposure % aRfD MOE Exposure % aRfD MOE 

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

Female 13-49:

 0.030050 3.01 3327 0.044269 4.43 2258 0.062163 6.22 1608 
Clomazone (125401) Dietary Exposure and Risk Assessment DP Number: 410437

Page 12 of 12

Attachment 3. Summary of the Chronic Dietary Exposure and Risk Estimates for Clomazone. 

U.S. EPA Ver. 3.16, 03-08-d

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

Residue file name: Clomazone.r08 Adjustment factor #2 not used.

Analysis Date 10-23-2013/15:35:33 Residue file dated: 10-23-2013/15:31:25

NOEL (Chronic) = 84.4 mg/kg body-wt/day

Reference dose (RfD, Chronic) = .84 mg/kg bw/day

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 Total exposure by population subgroup

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 Total Exposure

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 Population mg/kg Percent of 

 Subgroup body wt/day Rfd 

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Total US Population 0.011624 1.4%

Hispanic 0.011098 1.3%

Non-Hisp-White 0.011951 1.4%

Non-Hisp-Black 0.009601 1.1%

Non-Hisp-Other 0.013427 1.6%

Nursing Infants 0.010596 1.3%

Non-Nursing Infants 0.038583 4.6%

Female 13+ PREG 0.010948 1.3%

Children 1-6 0.015000 1.8%

Children 7-12 0.009739 1.2%

Male 13-19 0.007995 1.0%

Female 13-19/NP 0.008948 1.1%

Male 20+ 0.010812 1.3%

Female 20+/NP 0.012189 1.5%

Seniors 55+ 0.011227 1.3%

All Infants 0.029942 3.6%

Female 13-50 0.011548 1.4%

Children 1-2 0.016899 2.0%

Children 3-5 0.014233 1.7%

Children 6-12 0.010243 1.2%

Youth 13-19 0.008475 1.0%

Adults 20-49 0.011576 1.4%

Adults 50-99 0.011451 1.4%

Female 13-49 0.011536 1.4%

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