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### UNITED STATESENVIRONMENTAL PROTECTIONAGENCY WASHINGTON, D.C. 20460



### MEMORANDUM

Date: 7111/2014 OFFICE OFCHEMICAL SAFETY AND POLLUTION PREVENTION



### SUBJECT: Halauxifen-Methyl Chronic Aggregate Dietary (Food and Drinking Water) Exposure and RiskAssessment for the Section 3 Registration Action onBarley, Wheat, and Triticale

PC Code: 117501 Decision No.: 470169

Petition: 2E8086 RiskAssessmentType: Dietary TXRNo.: NA MRIDNo.: NA DP Barcode: D416128 Registration Nos.: 62719-AAE, AAG, AAN, AAR, AAU RegulatoryAction: Section 3 Registration CaseNo.: NA CAS No.: 943831-98-9 40 

### CFR: NA

FROM: Douglas Dotson, Ph.D., Chemist Risk Assessment Branch II Health Effects Division 7509P)

THROUGH:

# Je~fer Tyler,

# C~emi~ . .

# ~l~~ David Hrdy, Seruor Bio gist 

# '/ttl(!

# f**%J0~** Dietary Exposure Science Ad isory Council (DE )

TO: Maggie Rudick/Kable Bo Davis, PM Team 25 Herbicide Branch Registration Division (7505P)

Executive Summary

A chronic aggregate dietary (food and drinking water) exposure assessment was conducted using the Dietary Exposure Evaluation Model software withthe Food Commodity Intake Database

### Halauxifen-Methyl Dietary Exposure and Risk Assessment DP Number: D416128

(DEEM-FCID) Version 3.16. This software uses 2003-2008 food consumption data from the U.S. Department ofAgriculture's (USDA's) National Health andNutrition Examination Survey, What We Eat in America, (NHANES/WWEIA). The analysis was conducted as part ofa human healthrisk assessment for the use ofthe new active ingredient, halauxifen-methyl. The only proposed newuses for this chemical are barley, wheat, and triticale. This memorandum was reviewed by two peerreviewers oftheDESAC, per DESAC SOP 2012.1.
Halauxifen-methyl has a methyl ester moiety that converts to an acid moiety upon metabolism or environmental degradation. The acid metabolite is referred to as XDE-729 acid. The toxicological effects caused by parent halauxifen-methyl and the XDE-729 acid metabolite are different. The parenttargets the liver, while the metabolite causes kidney effects. Parent halauxifen-methyl causes toxicity at lower doses than the XDE-729 acid metabolite; however, exposure is predominantlyto the metabolite. Inthe field trials, no residues ofparent or acid
were found in wheat orbarley grain. The acid metabolite is a major degradate in drinking water. As the parent and metabolite have differenttoxicological effects, the toxicological databases for the two compounds were evaluated separately, and separate chronic toxicity endpoints were selected for them. Chronic dietary exposure assessments were performed for the two compounds separately. Forparent halauxifen-methyl, an assessment was performed for food and drinking water and a separate assessment was performed for drinking water only. The assessmentthat included food was based ontolerance level residues and the assumption that 100% ofall barley, wheat, and triticale consumed will be treated with halauxifen-methyl. For the acid metabolite, the assessment was based ondrinking water alone because the acid metabolite is not a residue of
concern in food, but it is a residue ofconcern in water.

In all three ofthe chronic dietary exposure assessments thatwere performed, the general U.S. population and all population subgroups used <1% ofthe chronic population adjusted dose (cPAD).

An 

### acute dietary exposure assessment was notperformed because acute dietary endpoints were not identified for the two compounds.
Halauxifen-methyl is classified as "not likely to be carcinogenic to humans at dose levels that do not induce livertoxicity or Cypla1 expression." As a result, cancerrisk is not ofconcern for this chemical.



### I. Introduction
Dietary risk assessment incorporates both exposure and toxicity ofa givenpesticide. For acute and chronic assessments, the risk is expressed as a percentage ofa 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 equivalentto the point ofdeparture (POD, NOAEL, LOAEL, e.g.) divided bythe required uncertainty or safety factors.

For acute and non-cancer chronic exposures, HED is concerned when estimated dietary risk exceeds 100% ofthePAD. References that discuss the acute and chronic risk assessments in

Page 2 of 12

### Halauxifen-Methyl Dietary Exposure and Risk Assessment DP Number: D416128

more detail are available onthe EPA/pesticides web site: "Available Information onAssessing Exposure from Pesticides, A User's Guide," 21 Jun 2000, web link: http://www.epa.gov/fedrgstr/EPA-PEST/2000/July/Day-12/606l.pdf; or see SOP 99.6 (20 Aug 1999).

As halauxifen-methyl is a newactive ingredient, this is the first dietary exposure assessment performed for the chemical.



### II. Residue Information

HED has determined that the residue ofconcern inplant commodities for risk assessment is parent halauxifen-methyl only. In drinking water, the residues ofconcern are parent, XDE-729 acid, X11449757, X11406790, and Degradates 1, 2, 4, 10, 11, and 14. HED decided that it was appropriate to perform separate dietary exposure assessments for parent halauxifen-methyl and the acid metabolite. For further details, seethe decision memo oftheResidues ofConcern Knowledgebase Subcommittee (D416125, E. Holman, 5/20/2014).

Chronic Assessment

Forboth assessments, the tolerance of0.01 ppmwas used as the residue input for all wheat, barley, andtriticale commodities.
Processing Factors
Processing factors were not used for any commodities 

### inthe assessments. The submitted processing study demonstrated that residues do not concentrate in cereal grainprocessed commodities. In

### addition, there are no defaultprocessing factors for the wheat orbarley processed commodities that appear in DEEM-FCID.

Residues in Fish

HED does not anticipate that the use ofhalauxifen-methyl onwheat, barley, andtriticale will result in residues infish. Tolerances are notbeing established for fish, and fish monitoring data
are not available for the chemical because it has notbeenregistered. As a result, residues in fish
are not included 

### inthe assessment.



### III. Percent Crop Treated Information

Forthe chronic assessments, the assumption was made that all commodities in DEEM-FCID, Version 3

### .16, would be treated to a level of 1 00%.

Page 3 

### of 12Halauxifen-Methyl Dietary Exposure and RiskAssessment DP Number: D416128



### IV. Drinking Water Data

EFED provided estimated drinking water concentrations (EDWCs) for the proposed uses (D406773, R. Bohaty, 6/12/2014). EFED provided values for parent, metabolite, and the total toxic residues in both surface and groundwater. Inall three cases (parent, metabolite, and total toxic residues) the groundwater values were higher thanthe surface water numbers. Forparent, EFED used the PRZM-GWModel and generated a maximum groundwater value of0.007 ppb. Forrisk assessment, the drinking waterresidues ofconcern include parent, the acid metabolite, and various othermetabolites. Forthe XDE-729 acid dietary exposure assessment, all residues ofconcern were included inthe EDWC, yielding a total toxic residue value of 19.5 ppb.



### V. DEEM-FCID Program and Consumption Information

Chronic dietary exposure assessments were conducted using the DEEM-FCID, Version 3.16, which incorporates 2003-2008 consumption datafrom USDA'sNHANES/WWEIA. The data
are based onthe reported consumption ofmore than 20,000 individuals overtwo nonconsecutive survey days. Foods "as consumed" (e.g., apple pie) are linkedto EPA-defined food commodities (e.g., apples, peeled fruit- cooked; fresh orN/S; baked; or wheat flour- cooked; fresh orN/S, baked) usingpublicly available recipe translation files developedjointlyby USDA/ARS and EPA.

Forchronic exposure assessment, consumption data are averaged for the entire U.S. population and withinpopulation subgroups. However, for acute exposure assessment, consumption data
are retained as individual consumption events. Based on analysis ofthe 2003-2008 WWEIA consumption data, whichtook into account dietary patterns and survey respondents, HED concludedthat 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.



### VI. Toxicological Information
Adequate data have been submitted to characterize the toxicity ofhalauxifen-methyl and XDE729 acid for the purposes ofdietary risk assessment. The database consists ofstudies onXDE729 acid, along with bridging and mechanistic studies onhalauxifen-methyl. Anacute dietary endpoint was not identified for eitherchemical. Inthe toxicity database, no hazard was observed from a single exposure. Long-term oral exposure studies were only conducted onXDE-729 acid; however, the rat subchronic oral studies on halauxifen-methyl exhibited lower NOAELs/LOAELs and different target organ specificitythanthe subchronic studies onthe acid metabolite. Therefore, the chronic dietary endpoint for halauxifen-methyl was based onthe molecular initiating event for livertoxicity inthe 90-day oral rat toxicity study onhalauxifenmethylto ensure that it is protective for potential effects from long-term dietary exposure to the parent compound. The chronic dietary endpoint for XDE-729 acid was based oneffects seen in the rat 2-year chronic toxicity/carcinogenicity study.

Page 4 of 12

### Halauxifen-Methyl DietaryExposure and Risk Assessment DPNumber: D416128

Halauxifen-methyl is classified as "notlikelyto be carcinogenic to humans at dose levels that do notinduce livertoxicity orCyplal expression." As a result, cancerrisk is not ofconcern for this chemical. The FQPA Safety Factorwas reduced to lxfor all population subgroups. The halauxifen-methyl doses and endpoints for dietary exposure assessment are summarized in Table 1. The XDE-729 acid doses and endpoints for dietary exposure assessment are summarized in Table 2.

Table 1.**Summ~iy** ofToXicological Doses ancJ Endpoints for Halauxifen-Methyl for Use in Dietary andNonOccu_l)_ational Human Health RiskAssessments Uncertainty/ RID, PAD, Level Exposure/Scenario Point of FQPA ofConcern for Study and Toxicological Effec;ts Departure Safety RiskAssessment Factors ,;-**~.** ,'· Acute Dietary (All 

## - populations, No hazard from a single exposure was identified in the available database; therefore, no risk is expected including Infants and Children and females from this exposure scenario.
age 13-49) 90-day oraltoxicity in the rat (halauxifen-methyl)
UFA= lOx Chronic RID = Increasedhepatic Cyplal expression (molecular UFH=lOx 0.03 initiating event for livertoxicity from AhR Chronic Dietary (All POD=3.0 FQPASF= mglkg/day activation) was observed at 10 mglkg/day. Populations) mglkg/day lx cPAD =0.03 [note: study NOAEL = 10 mg/kg/day, based on mglkg/day liver enlargement and pathology at 52 mglkg/day.] Classification: Not likelytobe carcinogenic to humans at dose levels that do not induce liver toxicity Cancer (oral, dermal, orCyplal expression. The cRfD is considered to be protective ofpotential cancer effects in the inhalation) absence oflong-term toxicity data on halauxifen-methyl because it protects for the molecular initiating event for livertoxicity from AhRactivation. Point ofDeparture (POD)=A data point or an estunated point that is denved from observed dose-response data and used to mark the beginning ofextrapolationto 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 ofthe human population (intraspecies). FQPA SF=FQPA Safety Factor. PAD= population adjusted dose (a=acute, c =chronic). RID= reference dose. MOE= margin ofexposure.

Table2. Summary ofToxicological Doses and Endpoints for XDE-729 acid for Use in Dietary**Huma~** Health Risk Assessments RID, PAD, •F •.. " ...,.
Pointof Uncertainty/ Level of Exposure/Scenario Departure FQPASafety Concern Study and Toxicological Effects Factors for Risk Assessment Acute Dietary (All populations, No hazard from a single exposure was identified in the available database; therefore, no risk is expected including Infants and from this exposure scenario. Children and females age 13-49)



### Page 5 

### of12

### Halauxifen-Methyl Dietary Exposure and Risk Assessment DPNumber: D416128

Table2. Summary ofToxicological Doses and Endpoints for XDE-729 acid for Use in Dietary Human Health Risk Assessments

. RID, PAD,



# . Uncertainty/ Level of Point of Exposure/Scenario Departure FQPASafety Concern Study and Toxicological Effects Factors for Risk

..i r.. Assessment Rattwo-year dietary chronic toxicity/carcinogenicity study
Chronic NOAEL = 101/20.3 mglkglday [M/F]
NOAEL= RID= 0.20 LOAEL = 404/101 mglkglday [M/F] based on 20.3 UFA= lOx mglkglday increasedmortality, altered urinalysis parameters, Chronic Dietary (All mglkglday UFH=lOx decreasedbody weight, increasedkidney weights, Populations) (female FQPA SF= lx cPAD= adrenal zone glomerulosahypertrophy, increased rats) 0.20 degeneration and regeneration ofrenal tubules and kidney stones, andbladderpathology in males; in mglkglday females, hyperplasia ofpelvic epithelium ofthe kidney.

Cancer (oral, dermal, Classification: Notlikelyto be carcinogenic to humans. inhalation) Pomt ofDeparture (POD) = A datapomt or an estimated pomtthat ts denvedfrom observed dose-response data and usedto markthe beginning ofextrapolation 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 =extrapolationfrom animal to human (interspecies). UFH =potential variation in sensitivity among members ofthe humanpopulation (intraspecies). FQPA SF=FQPA Safety Factor. PAD= population adjusted dose (a=acute, c =chronic). RID=reference dose.



### VII. Results/Discussion

As stated above, for a chronic dietary exposure assessment, HED is concerned when dietary risk exceeds 100% ofthe cPAD. The DEEM-FCID analyses estimate the dietary exposure ofthe U.S. population and various population subgroups. The results reported in Tables 3 and 4 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.

Forparenthalauxifen-methyl, an assessment was performed for food and drinking water and a separate assessment was performed for drinking water only. Forthe acid metabolite, the only assessment that was performed was for drinking water only. In all three assessments, the risk estimates are belowHED's level ofconcern for the general U.S. population and all population subgroups. Forbothparenthalauxifen-methyl andthe XDE-729 acid metabolite, the general U.S. population and all population subgroups used <1% ofthe cPAD.

Page 6 

### of 12Halauxifen-Methyl Dietary Exposure and RiskAssessment DP Number: D416128



### Table3. SummaryofDietaryExposure and RiskEstimates forParentBalauxifen-Methyl andXDE-729 Acid Population ParentHalauxifen-Methyl: ParentHalauxifen-Methyl: XDE-729 AcidMetabolite: Subgroup Drinking Water Only Food Plus Water Drinking Water Only cPAD Exposure Exposure cPAD Exposure mglkgl Estimate %cPAD Estimate, %cPAD mglkgl Estimate %cPAD

day mglkglday mglkglday day mglkglday
U

.S. Population 0.03 0.000000 <1 0.000017 <1 0

.20 0.000408
All infants* 0

.03 0.000000 <1 0.001010 <1 0.20 0.001053 Children 1-2 yrs 0.03 0.000000 <1 0.000040 <1 0

.20 0.000589 Children 3-5 yrs 0.03 0.000000 <1 0.000041 <1 0.20 0.000496 Children 6-12 yrs 0.03 0.000000 <1 0.000030 <1 0.20 0.000358 Youth 13-19 yrs 0.03 0.000000 <1 0.000018 <1 0

.20 0.000298 Adults 20-49 yrs 0

.03 0.000000 <1 0.000015 <1 0.20 0.000407 Adults 50-99 yrs 0.03 0.000000 <1 0.000012 <1 0.20 0.000403 Females 13-49 yrs 0.03 0.000000 <1 0.000013 <1 0.20 0.000406 *Most htghly exposed population subgroup



### VIII. Characterization ofInputs/Outputs

The chronic assessments are unrefined. They are based onthe assumptionthat all commodities will have residues atthe tolerance level and that all commodities will be treated to a level of 100%. Refinements are not needed atthis time. Inthe eventthat refinements are needed inthe future, they could be madeto both the residue levels and the percentage ofthe crop that is treated.



### IX. Conclusions

The chronic exposure estimates thatwere generated are conservative estimates ofthe actual dietary exposures thatmight occur. The aggregate (food plus drinking water) dietary risk estimates are belowHED's level ofconcern for the general U.S. population and all population subgroups. HED is confident thatthe chronic assessments do notunderestimate riskto the general U.S. population or any population subgroup.



### X. 

### List ofAttachments

Attachment 1. Halauxifen-Methyl Chronic Residue Input File (Food and Drinking Water) Attachment 2. Halauxifen-Methyl Chronic Residue Input File (Drinking Water Only) Attachment 3. XDE-729 Acid Chronic Residue Input File (Drinking Water Only) Attachment 4. Results ofHalauxifen-Methyl DietaryAssessment (Food and Drinking Water) Attachment 5. Results ofHalauxifen-Methyl DietaryAssessment (Drinking Water Only) Attachment 6. Results ofXDE-729 Acid Dietary Assessment (Drinking Water Only)

Page 7 of 12 <1
<1 <1 <I <1 <1 <1 <1 <IHalauxifen-Methyl Dietary Exposure and Risk Assessment DP Number: D416128

Attachment 1: Halauxifen-Methyl Chronic Residue Input File (Food and Drinking Water)

Chemical: Halauxifen-Methyl DEEMIFCID Program ver. 3.16, 03-08-d Filename: C:\Users\ddotson\Documents\DEEM Version3.16\HalauxifenMethyl\HalauxifenChronic.R08 Date created/last modified: 04-24-2014118:0I:05

NOAEL (Chronic): 3 mglkgbw/day RfD(Chronic): .03 mglkg bw/day

NoAcute Dietary Endpoint NOAEL (Acute): 0 mglkg bw/day RfD(Acute): 0 mglkg bw/day

Crop EPA Code Grp Commodity Name

1500025000 15 1500025001 15 1500026000 15 1500026001 15 1500027000 15 1500381000 15 1500381001 15 1500401000 15 1500401001 15 1500402000 15 1500402001 15 1500403000 15 1500404000 15 8601000000 86A 8602000000 86B Barley, pearled barley Barley, pearled barley-babyfood Barley, flour Barley, flour-babyfood Barley, bran Triticale, flour Triticale, flour-babyfood Wheat, grain Wheat, grain-babyfood Wheat, flour Wheat, flour-babyfood Wheat, germ Wheat, bran Water, direct, all sources Water, indirect, all sources Def Res (ppm)

0.010000 0.010000 0.010000 0.010000 0.010000 0.010000 0.010000 0.010000 0.010000 0.010000 0.010000 0.010000 0.010000 0.000007 0.000007 Adj.Factors #1 #2

1.000 1. 000 1. 000 1.000 1.000 1. 000 1. 000 1. 000 1.000 1. 000 1.000 1.000 1.000 1. 000 1. 000 1. 000 1. 000 1. 000 1.000 1.000 1. 000 1.000 1.000 1. 000 1.000 1. 000 1. 000 1.000 1. 000 1. 000 Comment

Attachment 2: Halauxifen-Methyl Chronic Residue Input File (Drinking Water Only)

Chemical: Halauxifen-Methyl DEEM/FCID Program ver. 3.16, 03-08-d Filename: C:\Users\ddotson \Documents \DEEM Version3.16\HalauxifenMethyl\HalauxifenChronic Water0nly.R08 Date created/last modified: 04-24-2014118:01:44

NOAEL (Chronic): 3 mg/kgbw/day RfD(Chronic): .03 mglkg bw/day

NoAcute Dietary Endpoint NOAEL (Acute): 0 mg/kg bw/day RID( Acute): 0 mglkgbw/day

EPA Crop Code Grp Commodity Name

---------- ------------------------------- 8601000000 86A Water, direct, all sources 8602000000 86B Water, indirect, all sources

Page 8 of 12 Def Res Adj.Factors Comment (ppm) #1 #2



## ---------- ------- 0.000007 1. 000 1. 000 0.000007 1. 000 1. 000

### Halauxifen-Methyl Dietary Exposure and Risk Assessment DP Number: D416128

Attachment 3: XDE-729 Acid Chronic Residue Input File (Drinking Water Only)

Chemical: XDE-729 Acid and Metabolites DEEM/FCID Program ver. 3.16, 03-08-d Filename: C:\Users\ddotson\Documents\DEEM Version3.16\Halaux.ifenMethyl\XDE-729 Acid Water0nly.R08 Date created/last modified: 04-24-2014/17:58:27

NOAEL (Chronic): 3 mglkg bw/day RfD(Chronic): .03 mglkg bw/day

NoAcute Dietary Endpoint NOAEL (Acute): 0 mglkg bw/day RfD(Acute): 0 mglkg bw/day

EPA Code Crop Grp Commodity Name

8601000000 86A water, direct, all sources 8602000000 86B Water, indirect, all sources

Page 9 of 12 Def Res (ppm) Adj.Factors Comment #1 #2

0.019500 1.000 1.000 0.019500 1.000 1.000Halauxifen-Methyl Dietary Exposure and Risk Assessment DP Number: D416128

Attachment 4: Halauxifen-Methyl: Results ofChronic Dietary Exposure Assessment (Food and Drinking Water)

DEEM-FCID Version 3.16, 03-08-d Food Consumption Survey: NHANES 2003-2008 2-day Residue file name: C:\Users\ddotson\Documents\DEEM Version3.16\HalauxifenMethyl\HalauxifenChronic.R08 Adjustment factor #2 NOTused. Residue file dated: 04-24-2014118:01:05 Analysis Date 04-24-2014/18:05:08

Total exposure by population subgroup

Population

Subgroup

Total US Population Hispanic Non-Hisp-White Non-Hisp-Black Non-Hisp-Other Nursing Infants Non-Nursing Infants Female 13+ PREG Children 1-6 Children 7-12 Male 13-19 Female 13-19/NP Male 20+ Female 20+/NP Seniors 55+ All Infants Female 13-50 Children 1-2 Children 3-5 Children 6-12 Youth 13-19 Adults 20-49 Adults 50-99 Female 13-49 Total Exposure mg/kg body wt/day

0.000017 0.000017 0.000018 0.000016 0.000017 0.000006 0.001012 0.000014 0.000041 0.000028 0.000020 0.000016 0.000016 0.000012 0.000011 0.001010 0.000013 0.000040 0.000041 0.000030 0.000018 0.000015 0.000012 0.000013

Page 10 of 12 Percent of Rfd

0.1% 0.1% 0.1% 0.1% 0.1% 0.0% 0.0% 0.0% 0.1% 0.1% 0.1% 0.1% 0.1% 0.0% 0.0% 0.0% 0.0% 0.1% 0.1% 0.1% 0.1% 0.0% 0.0% 0.0%Halauxifen-Methyl DietaryExposure and RiskAssessment DPNumber: D416128

Attachment 5: Halauxifen-Methyl: Results ofChronic Dietary Exposure Assessment (Drinking Water Only)

DEEM-FCID Version 3.16, 03-08-d Food Consumption Survey: NHANES 2003-2008 2-day Residue file name: C:\Users\ddotson\Documents\DEEM Version3.16\HalauxifenMethyl\ HalauxifenChronicWaterOnly.R08 Adjustment factor #2 NOTused. Residue file dated: 04-24-2014/18:01:44 Analysis Date 04-24-2014/18:06:10



### ===============================================================================

Population

Subgroup

Total 

### us Population Hispanic Non-Hisp-White Non-Hisp-Black Non-Hisp-Other Nursing Infants Non-Nursing Infants Female 13+ PREG Children 1-6 Children 7-12 Male 13-19 Female 13-19/NP Male 20+ Female 20+/NP Seniors 55+ All Infants Female 13-50 Children 1-2 Children 3-5 Children 6-12 Youth 13-19 Adults 20-49 Adults 50-99 Female 13-49 Total exposure by population subgroup

Total Exposure
mg/kg body wt/day

0.000000 0.000000 0.000000 0.000000 0.000000 0.000000 0.000000 0.000000 0.000000 0.000000 0.000000 0.000000 0.000000 0.000000 0.000000 0.000000 0.000000 0.000000 0.000000 0.000000 0.000000 0.000000 0.000000 0.000000

Page 11 of 12 Percent of Rfd

0.0% 0

. 0% 0

. 0% 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% 0

. 0% 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% 0.0%

### Halauxifen-Methyl Dietary Exposure and Risk Assessment DP Number: D416128

Attachment 6: XDE-729 Acid: Results ofChronic Dietary Exposure Assessment (Drinking Water Only)

DEEM-FCID Version 3.16, 03-08-d Food Consumption Survey: NHANES 2003-2008 2-day Residue file name: C:\Users\ddotson\Documents\DEEM Version3.16\HalauxifenMethyl\ XDE-729 Acid Water0nly.R08 Adjustment factor #2 NOTused. Residue file dated: 04-24-2014/17:58:27 Analysis Date 04-24-2014/18:08:32

Total exposure by population subgroup

Total Exposure Population

Subgroup

Total US Population Hispanic Non-Hisp-White Non-Hisp-Black Non-Hisp-Other Nursing Infants Non-Nursing Infants Female 13+ PREG Children 1-6 Children 7-12 Male 13-19 Female 13-19/NP Male 20+ Female 20+/NP Seniors 55+ All Infants Female 13-50 Children 1-2 Children 3-5 Children 6-12 Youth 13-19 Adults 20-49 Adults 50-99 Female 13-49 mg/kg body wt/day

0.000408 0.000390 0.000420 0.000337 0. 000471 0.000369 0.001358 0.000384 0.000523 0.000340 0.000281 0.000315 0.000380 0.000429 0.000395 0.001053 0.000406 0.000589 0.000496 0.000358 0.000298 0.000407 0.000403 0.000406

Page 12 of 12 Percent of Rfd

0.2% 0.2% 0.2% 0.2% 0.2% 0.2% 0.7% 0.2% 0.3% 0.2% 0.1% 0.2% 0.2% 0.2% 0.2% 0.5% 0.2% 0.3% 0.2% 0.2% 0.1% 0.2% 0.2% 0.2%