### 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 Ef fects Division (HED) (7S09P)

THROUG H: Thurston Morton

, Chemist, Senior Scientist RABJV, HED (7S0 9P ) and 

## n Dougla s A. Dot so n , Ph.D

., Chemist

## ~ ·

## ~)~ Kristin Rury, Biologist 

# 'f 

# Q---x Dietary E xposure Science Advisory**~cil** 

### (DE SA C), HED (7S09P)

TO: Sidney Jackson/Barbara Madden, PMOS Risk Integration Minor Us e Emergency Response Branch Registration Division (7SOSP)

Execut ive Summary

Acute and chronic aggregate di e tary (foo d and drinking water) exposure and risk assessme nts

were conducted using the Dietary Exposure Eva luation Model software with the Foo d Co mmodit y Intak e Database (DEEM-FC ID) Version 3.1 6

. This software u ses 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/WWE IA). The analy ses
Page 1 of 12C1omazone ( 1 2 5401) Dietary Expo s ure and Risk Assessment DP Number: 410437

were conducted in support of a human health risk assessment for the proposed Section 3 use s 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 DES AC SOP 2012.1.

Both th e acute and chronic assessmen t s are highly conservative and incorpor ated tolerance l eve l residue s , assumed 100 % crop treated and used default proc essing factors. Screening-level Tier I modeling was used to estimate drinking wa ter concentrations.

The acute dietary risk estimate at the 95 1 h percentile of exposure utilized 3.0% of the acute population adjusted dose (aPAD) for fema le s 1 3-49 years old. T hi s is the only population subgroup for which an acute en dpoin t was se l ecte d. The acute dietary risk estimate fo r females 13-49 years old is not of concern.

The chronic dietary ri s k es timates are :53.6% of the chronic population adju ste d dose (cPAD) for all population s ubgroups. All Infants < 1 year of age is the most highl y exposed su b gro up , utilizing 3.6% ofthe c PAD

, while the general US population utilizes 1.4% of the cPAD. The chronic dietary risk estima t es are not of concern.

Clomazone is not lik ely to be carcinogenic to humans; henc e, a cancer exposure and risk
assessment was not conducted.



### I. Introduction

Dietary risk assessment incorporates both expos ure and toxicity of a given pesticide. For acute and chronic assessme nt s, the risk is expres se d as a percentage of a maximum acceptable dose (i.e., the dose that HED ha s concluded will result in no unrea so nable adver se h ea lth effects). This do se is referred to as the population adjus ted dose (PAD). The PAD i s e quivalent to the point of departure (POD

, NOAE L

, LO AEL

, e.g.) divided by the required unce rtain ty or sa f ety factors.

For acute and non-cancer chronic exposure s, HED is concerned w hen estimated dietary risk exceeds 100% ofthe PAD

. References tha t di sc uss the acute and chronic risk assessments in

more detail are available on the EPA/ pe sticides web site: " Avai l able Information on Assessing Exposure from Pesticid es , A Use r 's Guide ," 21 -JUN-200 0

, 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 potatoe s, tomatoes and bell peppers, and alfalfa

, HED concludes that the natur e of the residue in plants is adequately und erstood. The major metabolite was 2-chlorobenzyl alcohol. The po stu la te d major route of metab o li sm of clomazone in plants i s h y dr oxylatio n of the m e th ylene bridge carbon of

Page 2 of 12Clomazone (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 ca rboxylic 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 a re established under 40 CFR §180.4 25 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. 0 5

-- Bras s ica , 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

-- R h ubarb

-- 0. 30 Soybean 0.05

-- Spearmint, tops 0.05

-- Squash, summer 0.1

-- Squash, winter 0.1

-- Sugarcane, can e 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 ha s 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



### Page 4 of 12 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 anae robic aquatic metabolism study. In the aerobic aquatic study it reached only 11% of parent at one sampling interval. Based on these data, an a d h oc HED MARC (Metabolism Assessment Review Committee; D268905; 10/2/00) determined that the parent and i ts degradate

, FMC65317 , are residues of concern in drinking water

.

Fish: N o tolerances are currently established for resi dues 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 detecta ble residues. As a result, residues in fish were no t included in the
assessment.

I I I. 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 memorand a : “ C lo mazone: Drinking Water Exposure Assessment for Proposed New Uses for Brassica (Head and Stem Subgroup 5A), Southern Peas, and Rhubarb ” ( Both memoranda under D 408878 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 D EEM

- 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 r ice ( dry

- seeded 0.8 lb ai/A )

. The Tier 1 Rice model ( dry

- seeded scenario ) produced the highest EDWC s 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



### Page 5 of 12 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) 1 0.8 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 conside red. Hence, t his 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 floo ding ; however, significant levels of the metabolite FMC 65317 are not expected to form during this interval under these aerobic conditions. T h e 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 model s and t heir description s 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 DEEM

FCID, 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 t wo 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 trans lation 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 in dividual 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 g eneral 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 p esticide 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 capitaClomazone (125401) Dietary Exposure and Risk Assessment DP Number: 410437



### Page 6 of 12 exposure and risk are reported for a nalyses 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 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 es timate. 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/k g 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 observe d 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 toxi city 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 r ats, 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. Th e chronic popu lation 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 cance r 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



### Page 7 of 12 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 pop ulation subgroup. Acute Dietary ( Females 13

- 50 years of age) NOAEL= 100

mg/kg/day UF A =10x

UF H =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 UF A =10x

UF H =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 hydro

nephritic kidneys in males. Cancer ( all
rout es ) 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 o bserved adverse effect level. LOAEL = lowest observed adverse effect level. UF = uncertainty factor. UF A = extrapolation from animal to human (interspecies). UF H = potential variation in sensitivity among members of the human population (intraspecies). FQPA SF = FQPA Safety Factor. PAD = population adjusted dose (a = acute, c = 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 D EEM

- FCID TM 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 0.0 11624 1. 4 All Infants (<1 year old) 0.02 9942 3. 6

N/A N/A Children 1

- 2 years old 0.01 6899 2.0
Children 3

- 5 years old 0.01 4233 1. 7
Children 6

- 12 years old 0.0 10243 1. 2
Youth 13

- 19 years old 0.00 8475 1 .0
Adults 20

- 49 years old 0.0 11576 1. 4
Adults 50

- 99 years old 0.0 11451 1. 4
Females 13

- 49 years old 0.0 30050 3.0 0.0 11536 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 c onservative 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 analys is was performed for the general U.S. population and various population subgroups. The acute and chroni c 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

. S ummary of the Acute D ietary 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 N OEL(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 1C D 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 050106900 0 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, pi geon, 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 1.00 0 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 Peppe r, 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 1.000Clomazone (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, f lour 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 1.00 0 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 Spear mint 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 1.000Clomazone (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
RA C/FF intake summed over 24 hours Run Comment: ""

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

Summary calculations

-- per capita:

--- 95th Percentile

---- --- 99th Percentile

---- --- 99.9th Percentile

---- Exposur e % 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 1608Clomazone (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 Ve r. 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

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

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

Total Exposure

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

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