### Di fenoconazo le PC Code: 128847 Dietary Exposure Assessment DP# : 42649 1



## UNITED STATES ENVIRONMENTAL PROTECTION AGEN C Y WASHINGTON , D.C. 20460 Offi ce of C h em i ca l Safety a n d Po ll utio n Preve n tion 

### MEMORANDUM
Date : 1-J ul y-20 1 5
S ubject: 

### Difenoconazole. Acute and C hronic Aggregate Di e tary Ex p os ur e and R is k Assessme nt s fo r th e Pe tition fo r Use of Oifenoc o n azole on G lobe A rtic hoke, Gin se ng and Gree nh ouse Grown Cucumbers and Co nver s ion of th e Es tabli s hed Fol iar Uses/To le rances for S tone Fruit and Tree N ut Crop Groups to Fruit , Sto ne , Group 12

- 

### !? d l N T G 14 

### !?

- an t 1e ut, ree , roup 

# - -·

PC Code: 12884 7 DP Barcode : 426491 Dec is ion No.: 491006 Registration No.: 100-1262 , 100

- 13 13 , 100

- 1317 P

etiti o n Nos.: 4E8274 R eg ul atory Actio n : Amended Section 3 A

ssess m e nt Type: S in gle Chemic al, Dietar y R eg istrat ion Case No.: NA TXR No.: No ne CAS No.: 11 9446 -68 -3 MRID No.: None 40 CFR: 180.475


### R ev iewer: T hurston G. Morton , C hemist

# ~A**,,,, cr­**  Ri s k Assess ment Branch IV/ Hea lth Effec ts Di vis io n (RABJV/HED ; 7509P)
T hrough: ldeli z Neg r6n-En carnaci6n , C he mist

# ~ .__ ___ _ N ancy D o dd , Chem is t

## ~**~** Dietary Exposure Scie nce

### Advi~ Co unci l (D ESAC)
And
C harle s Smith, Acti n g Branch C hie RAB IV/ H E D (75 0 9 P)
To: Ivan Nieves , Ri s k Assesso r R A BIV/ H E D (7509 P)
And
To ny K is h 

### (RM 22) F ungicide Branch Registration Di v is io n (7505 P )

l 

### of29Difenoconazole PC Code: 128847 

## Exec utiv e S umm ary Dietary Exposure Assessment DP # : 426491



### Difenoconazo le acute and chronic dietary exposure and risk assessments were conducted using the Dietary Ex po s ure Evaluation Model software with the Food Commodity Intake D atabase ( DEEM-FC ID) Version 3.16. This software uses 2003-2008 food consumption data from the U.S. Department of Agriculture's (US D A's) National Health and Nutrition Examination Survey, What We Eat in America, (NHANES/WWElA). The analyses were performed to support the Section 3 registration on gi n seng, g lobe artichoke , and the expansion to crop group 12-12 and 14- 12 of th e fungicide difenoconazole [ l

- [2-[2-chloro-4-( 4-chlorophenoxy) phenyl]-4-methyl-1 ,3

- dioxolan-2-ylmethy l]-1 H-1,2 ,4-tr iazole]

. T hi s memorandum was reviewed by two peer reviewers of the DESAC , per DESAC S OP 2012.1.
The unrefined acute analysis assumed tolerance-level residues, I 00% crop treated (CT), and the available e mp irical or DEEM (ver. 7

. 81) default processing factors. The somewhat refined chronic analysis assumed tolerance-level residues for some commodities , average field trial res idues and US DA Pesticide Data Pro gram monitoring samp les for the remaining commodities , the available e mpirical or DEEM (ver. 7.81) default processing factors, and% CT assumptions for some commodities. The EDWC of20.0 

### μg/L (ppb) was used for the acute dietary exposure analysis and an estimated drinking water concentrations (E DW C) of 13.6 

### μg/L (ppb) was used for the chronic dietary exposure analysis.
The re s ulting acute food plus water dietary exposure estimates were less than H ED's level of concern ( < I 00% of the acute population-adjusted dose (a PAD)) at the 95th percentile of the exposure distribution for the general U.S

. population ( 1 5% aPAD) and all population sub-groups; the most hi g hly exposed population subgroup was c hildre n 1-2 years old with 49% aP AD. The resu ltin g chro ni c food plus water dietary exposure es timates were less than HED's level of concern (< 10 0% of the chronic population-adjusted dose (cPAD)) for the general U

. S. population (26% c PAD) and all population s ub-group s; the most h ig hl y exposed popu lation s ubgroup was ch ildre n I - 2 years old w ith 89% cPAD

. No cancer ana lys is was performed since it was determined th e chronic dietary exposure assessment is protective of cancer effects

. 

## T h e di etary ex po s ure analyses for the triazole metabolites was recently upd ated (D426492 , T. Morton , 4/ 9/ 15 ).

2 of29Difenoconazole PC Code: 128847 

### I. Introduction Di etary Exposure A ss e s s ment D P# : 426491



### Di etary risk a ssess ment incorporates both expo s ure and toxic ity of a g i ve n pes ticide. For acute and c hro nic assessm e nt s, th e ri s k i s expre ssed as a percentage of a m ax imum acceptab le do se ( i.e. , the dose which HED has co ncluded will re s u lt in no unreaso n ab le adver se hea lth effects). Th is dose is referred to as the PAD. The PAD is eq uivalent to the point of departure ( POD , NOAEL, LOAEL , e.g.) d ivided by the requ ir ed un certainty or safety factors.
Fo r acute and non-cancer c hro ni c exposures , H E D is concerned w hen es tim ated dietary ri sk exceeds 100% of the PAD. Refere nce s w hich di sc u ss the ac ute and chronic ri sk assess me nt s in more detail are availab le o n the EPA/pesticide s web si te : " Avail able In fo rmation on Assessing Ex posure from P es ti c ides, A User's Guide," 2 l-J UN-2 000, we b link : http: //www.epa.gov / fed rgs tr / E PA -PE S T/ 2000/Jul y / Day -l 2/ 6061.pdf ; or see SO P 99

. 6 (20-A U G1999).
The most recent di etary ri sk assess ment for d i fe noconazo le was conducted by 

## T. Morton ( l 5- January-2015 ; DP#4 128 1 2).


## II. Residue Information
Di fe noconazol e t o le ran ces are pub li shed in 40 CF R § 180.475

. 

### Residues of Concern in Plants and Livestock:
Residues of concern were determined based on recommendations from the H ED R es idue s o f Concern Knowl e dgebase S ub-committee ( ROCK S) ( D3 9 1 350, 9/19/ 11 ). Th e res idue of concern for p lant commod iti es fo r tolerance express ion and ri s k assessment purp oses is di fe noconazo le 

### per se. The H ED RO CKS has determined that the pare nt co mpound a nd th e CGA-205375 metabol ite are the res idue s of co ncern in livestock co mmodities fo r both th e tol e rance express ion and the risk assessme nt. In add ition, metabo lite O H -CGA-169374 , wh ic h co mpri sed 15 % of the TRR in goat milk , s ho uld be considered as a res idue of concern for the d ietary ri s k assessment. Based on available goat metaboli sm d ata in milk , to ta l res idue s of concern for dietary risk assess ments , s hould be ca lculated by multiplying th e to le rance in milk by a factor of l .5x to accou nt for the m etabo lite O H- C G A -1 69374. Tab le I s ummari zes tol e ra nce ex pression and the residues of concern in plant and li v esto ck co mmod iti es . rrab l e I. Difenoc o na zo l e Res idue s of Concern in P lants a nd Ruminants . Matri x Residues of Co ncern F o r Ri s k Assessment For To l erance Exoress ion Pl ant s Primary and Rot ati o nal crops Parent On ly Parent Onl v Livestock R uminant and Pou lt ry Parent and CGA 205375 Parent a nd CGA 205375 Milk Parent. CGA 205375, and Parent and CGA 205375 O H-CGA-169374 Drinking Water Parent Only NA No te: The 1riazole-containing metabolites 1 , 2,4-T, TA

. and TAJ\ s hould be included in the re s idues of concern for risk ass e ss ment purposes only for plant and livestock commoditie s. S ince the s e metabolites are common to th e e ntire class of lra izo l e-dcrivative fung i cide s a nd becau s e of ditTerentia l toxicity between me1abo li 1 cs a nd th e vario u s parenl co mpound s, ri s ks associated with exposure to 1 ,2.4-T a nd lo TAIT AA are addre ss ed s epara te l y . 

### 3 of29Di fenoconazole PC Code: 128847 Dietary Exposure Assessment DP# : 426491



### Recommended Tolerances: Based on the residue chemistry data submitted with the previous petitions , HED recommended for establishment of the new food tolerances (D P# 421089 , B

. Cropp-Kohlligian, 28-January-2015)

. The recomme nded, established , and rev ised tolerances are listed in Tab le 2 below

.

Ta bl e 2

. T o le r a n ce S umm a r y fo r Dif e n oco n azo le ( n o n - fee d ite m s)

. Commodity Exist ing/Established New To lerances Average Field Trial Residue Tolerances (ppm) (ppm) or average PDP Residue (ppm) Rapeseed crop subgroup 20A 0.10



## ------ 0.10 Brassica subgroup 5A 1.9 .. . ......... . .. 2013 PDP data = 708 samples/ I detects/highest det of0.019 u s ed in chronic for broccoli Cabbage = 0.029 Bras sica subgroup 58 35


## -- -- · -- 5.10 Citrus oil 25 

### ............... 25 Fruit , citrus , group I0 0.6


## ------ 201 1 / 12 PDP data = 1426 samp les/ O detects/highest

LOO of0.005 used in

chronic for citrus Grape 4.0
................. 0.613 2013 PDP data = 176 samples/O detects / highest 1 / 2 LOO of0.005 used in chronic for grape juice Grape , raisin 6.0
..... . ........... 0.615 (3.5x PF) Nut , tree , group 14-12 0.03 ................ Almond = 0.005 Pecan = 0.007 Onion , bulb , subgroup 3-07 A 0.20 ................. 2011/12 PDP data = 744 samples /O detects/highest 

### Yi

LOO of0.0025 used in chronic Onion , green , subgroup 3-078 6.0 .... ............. 6.0 Pistachios 0.03

...... . ... ...... ... 0.005 Vegetable , cucurbit , group 9 0.7



## ------ 2011/12 PDP data = 744 samples/ O detects/highest 

### Yi

LOO of0.0025 used in chronic for cantaloupe

Cucumber = 0.055
2011 / 12 / 13 PDP data = 1115 samples/I detects/highest det of 0.0 I I used in chronic for

squash/pumpkin Fruit , Pome , group I I 1.0



## ------ Apple = 0.203 Pear = 0.123 

### 4 of29

### Difenoconazole PC Code: 128847 Dietary Exposure Assessment

Table 2. Tolerance Summar y for Dif e n oconazo le (no n-f eed ite m s). Commodity Existin g/EstabI ished New Tolerances Tolerances (ppm) (ppm) Vegetable , Fruiting , Group 8-10 0.60 

## ------

Vegetable, Tub erous and Conn , 4.0


## ------ s ub g roup IC Beet. s ugar 0.30 ____ 

### .._ 

### Papaya 0.30 ............ 

### Ban ana 0.2 

### .............

Barley , g ra in 0. 1 

### .............. Cattle fat 0.10



## ------ Cattle , meat 0.05 

# ------ Cattle , meat byproducts 0. 10



## ------ Cattle , liver 0.40


## ------ Co rn , sweet, ke rn e l plu s cob 0.01


## ---- -- with husks removed Cotto n , undelinted seed 0.05


## --- --- Eoo 0.0 2 

### .............



## "'"' Goat. fat 0.10
.... ........ 

### Goat, meat 0.05 

### ............ Goat. meat byproducts (except 0.10


## ------ liver) Goat , liv er 0.40 

### ............ .. Hog , fat 0.10


## ------ Hog , meat 0.05 

### ............. Hog, meat bypro ducts (except 0.1


## -- ---- liver) Hog. liver 0.40 

## ------ Horse, 

### fat 0.10


## ------ Hors e. meat 0.05


## ----- - Milk 0.02 prop osed to be
.... ......... 

### in cre ase d from 0.0 I ppm Rye. grain 0.0 1 

### ............... Sheep. fa t 0.10



## ---- -- Sheep. meat 0.05 .... ............ 

### Sheep , meat byproducts (except 0. 10


## ---- -- liver) Sheep , li ver 0.40 

### .. ........... Wheat. g rain 0.1 

### .............. 

## 5 of29 DP # : 426491

Average Field Trial Res idue

or average PDP Res idue ( ppm) Tomato 

### = 0.165 Pe pp er = 0.133 Eggplant=0.133 Okra=0.6 1. 36
0.30 0.30 20 12/ 1 3 PDP dat a = 1267 sample s/O detec ts/highest 

### Yi

LOO of0.0025 used in

chronic for banana 0.10 0. 10 0.05 0.10 0.40 0.0 1
0.05 0.02 0.10 0.05 0. 10
0.40 0.10 0.05 0

. 10
0.40 0.10 0.05 0.02

0.0 1 0.10 0.05 0.10
0.40 0.10Difenoconazole PC Code: 128847 Dietary Exposure Assessment

Tab le 2. Tol e ran ce S umm a r y for Difenoc o n azo le ( n o n-f ee d ite m s). Commodity Existi ng/Established New Tolerances T olerances (ppm) (ppm)
Wax apple 0.07


## ------ Mango 0.07


## ------ Carrot 0.50 

### .............

Soybean , seed 0.15


# ------ Fruit, s tone , gro up 12- 12 2 .5 

### ............

Strawberry 2.5


## ------ Turnip greens 35 

### ............ Oat, grain 0.01


## ------ Wax Jambu 1.5 Dragon fruit 1 .5 (trans lated from waxjambu) Pea an d bean , dried s he ll ed , 0.20 excep t soybea n , s ubg roup 6C Bushberry s ub group 1 3-07 8 4.0 G lobe Artichoke 1.5 Ginseng 1. 0 DP # : 426491

Average Field Trial Residue

or average PDP Residue (ppm) 0.07 0.07 20 1 3 PDP carrot data = 712

samp les/ I I detects / max detect of0.007 used for chronic 0.02 1 5 Cherry = 0.622 20 1 3 PDP data = 285 samp le s/ 6 detects/highest det of0.038 used in chronic for peach 20 13 PDP data = 543 samples/ 5 detects/highest det of0.004 used in chronic for nectarine 2011 / 12/13 PDP dara = 1347 samples / O detects/highest 1 / 2 LOD of 0.0025 used in chronic for plum 0.495 5. 10 0.01

1.5 1.5
Dried bean = 0.0 14 Dried pea = 0.034 1.009 0.469000



### 0.316 

## The dietary expos ure ana lyses for the triazo le metabo li tes (0426492, T. Morto n , 4/ 9/15) was recentl y updated. Addition of these use s did not s ignificantly change the dietary expo s ure for the triazole metabolite s . Food Residues and processing fac tors used in the Ac ute and Chronic Analysis: The acute analys is ass umed tolerance-level residue s and l 00% CT fo r a ll the reg i stered and proposed crops. Tolerance-level res idues were a lso assumed for all li ves tock ti ss ues in thi s assessment. The c h ron ic analysis assumed toleranc e -level residues for so me co mmoditi es, average field trial res idues and 

## US D A PDP average residues for th e r e mainin g co mmoditi es, and% CT assumption 

## for so me co mm oditie s . Those co mmoditi es w here field tri a l data were used are s ummari zed be low. 

## H ED SOP 2000.l 

### Gu idancefo r T r anslation of Field Tr ial Data from R e pres en tative Co mmodities in th e Crop Group Regulation to Oth er Co mmodities in Each C rop 6 of29

### Difenoconazole P

C Code: 128847 

### Di etal)' Expo sure Assessment DP# : 426491


## Group /

S ubgroup dated 9112/ 2000 was used in tran s lati ng to other commodities in the crop group. Ex perimental proces s in g factors were used for app le juice (0.04x), grape juice (0.2x) , citrus juices 

### (O. lx) , potato chips (0.5x), potato granu les/fla ke s (0.5x), raisin (3.5x chron ic on ly since the raisin to lerance wa s u sed in acute), sugar beet molass es (0.6x) , tomato paste ( 1 .6x) , and tomato puree (0.5x); DEE M (ver. 7 .8 1) default proc ess ing factors were assumed for other processed commoditie s . A lmond: Average field trial residue was used fro m MRID 47586101.**~:Average** 

### field trial residue was u sed fro m MRlD 46950233. Pea and Bean, Dried S he lled , Excep t Soybean, Su bgroup 6C : F ield trial r es idues were used from MRID 49227601. Banana: Hi g hest LOO of 0.0025 ppm in 2012/ 2013 U SDA PDP data u se d. PDP found 0 detect s in 1267 banana s ampl es t es ted.
Brocco li: Highe s t res idue in 2013 US DA PDP data used (0.019 ppm)

. PDP found l detect in 708 samples tested. Bushbeny: Average fi e ld tria l re s idue was used from MRJD 49227602. Cabbage: Average field trial residue was used from 47586102

. Re s idues from 1-7 day PHI were used s ince registered labels allow from 1-7 d ay PHi s. To refine the dietary exposure data from o nl y cabbage samp les without wrapper leaves we r e used. C antaloupe: Hi g hes t LOO of0 .0025 ppm in 2011 / 2012 US DA PDP data used. PDP found 0 d etec ts in 744 canta loupe samples tested. Ca rrot: High es t d etect of 0.007 ppm in 2013 USDA PDP data used

. PDP fo und 11 detects in 712 carrot samples tested. C hickpea: Average fi e ld trial re sidue was used from MRJD 47929805. C ucumber: Average fi e ld tri al residue was used from MRID 4758610 3

. R es idues from 0 -1 day PHI were used since regi s t e red labels allow from 0-1 day PHI. Grape: Highe st LOD of 0.005 ppm in 20 I 3 USDA PDP data used for grape juice. PDP found 0 detec t s in 176 grape juice samples tested. Ave r ag e field trial residue from MRTD 4 7586105 used for grape. Grapefru it: Hi ghest LOO of 0.005 ppm in 20 1 1/20 12 US DA PDP data u sed. PDP found 0 detects in 1426 citrus sample s tested.
Lemon: Highest LOO of0.005 ppm in 201 1/ 2012 US DA PDP data used. PDP fo und 0 detects in 142 6 citrus samp les t es ted. Lime: Highe st LOO of 0.005 ppm in 201112012 US DA POP data used. POP found 0 detects in 7 of29

### Di fenoconazole 

### PC C ode: 128847 

### 1426 citrus samples tested. Dietary Exposure A ss e ss ment 

### DP # : 426491



### Mu s tard Greens: Average fi e ld trial residue was us ed fro m M RID s 47417704 , 474 17707, and 47586102. Re s idue s from 1-7 day PHI were u sed si nc e regi s tered labe ls a llow from 1-7 day PHi s. Nectarine: Hi ghest detect of 0.004 ppm in 2013 USDA PDP data used. PDP found 5 detects in 543 nectarine samples tested. Onion, bulb, subgroup 3-07 A: Highest LOO of 0.0025 ppm in 2011 /2012 USDA POP data used. PDP found 0 detects in 744 onion samples tested. Orange: High est LOO of 0.005 ppm in 20 11 / 20 12 USDA PDP data used. PDP found 0 detects in 1426 citrus samples tested.
Peach: Highest de tect of 0.038 ppm in 2013 USDA PDP data used. PDP found 6 detects in 285 peach samp le s tested.
Pear : Average field trial residue was used from MRJD 46950233.
Pecan: Average field tria l res idue was used from MRID 47586106. Peppers: Average field trial residue was used from MRID 46950234.
Plum: Highest LOO of 0.0025 ppm in 2011 / 20 12/ 20 1 3 USDA PDP data used. PDP found 0 detects in 1347 plum samp les tested.
Potato: Average field trial residue was used from MRID 47929804. Soybean : Average field trial re sidue was used from MRID 47929801.
Stone Fruit: Average field trial residue was used from MRID 47929803. Strawberry: Average fie ld trial residue was used from MRID 47929802. Sugar Beet: Average field trial residue was used from MRID 46950236.
S ummer Squash: Hi g hes t detect of0.011 ppm in 20 11 / 20 12/20 1 3 USDA PDP data used for sq ua s h and pumpkin. POP found 0 detects in 744 squas h sample s tested.
Tomato: Ave rage field trial residue was used from MRIDs 46950234 , 47417705, and 47417708.



## 8 of29

### Difenoconazole PC Code: 128847 

### Dietary Exposure Assessment



### III. P ercent C rop T reated Information DP# : 426491



### The acute dietary exposure ana lyses ass umed 100% crop treated (CT). Average %C T was used for t he following crops : almo nd 5%, cabbage 2.5%, cucumb e rs 5%, ga rli c 5% , grape 5% , grapefruit 2.5%, onions 5%, orange 2.5% , pecan 2.5%, peach 1 %, peppers 2.5% , p i s tachi o 2.5%, pumpkin 2.5%, squash 5% , strawberry 2.5%, sugar beets 15% , tangerine 2.5%, tomatoes 25% , walnut 2.5%, watermelon 5%, and wheat 10%. 

## IV. Drinkin g Water Data The drinking water estim ates u sed in the dietary risk assessme nt were provided by the Environmental Fate and Effects Division (EFED ; Memo , F. Khan , l 3

-November-2014; 042109 2). The EDWCs for su rface water for the requested new uses d i d not supersed e the previously recommended drinking water concentratio ns. For s urface water, revised recomme nded EDWCs are 20.0 μ g/L for peak , 1 3.6 μg /L for annual mean and 9.9 μ g/L for annua l average concen tratio n s . Recommended EDWCs fo r human health are 

### 20.0 μ g/L (ppb) for the ac ute dietary (food plus wate r) exposure ana lys i s and the I -in-10 year ann ual mean E DWC of 13.6 μg/L (ppb) for the chron ic dietary (food pl u s wate r ) exposure analysis.


### V. DEEM-F C ID Progra m and Consumption Information
Oifenoconazole acute and c hro nic di eta ry expos ure assess me nt s we re conducted u sing the Dietary Exposure Evalu ation Model software with the Food Commod ity Intake Database DEEMFC ID , Version 3.16, whic h incorporates co n sumption data from USDA's National Health and N utrition Ex amination Survey , What We Eat in Ameri ca , (N H ANES/WWEIA). T his dietary survey was conduc ted from 2003 to 2008. T he data are based o n the reported co ns umption of more than 2 0 ,000 individual s over two non-c o nsec utive s urv ey day s. Foods " as consumed" (e.g. , app le pie) are li nked to EPA-defi ned food commod itie s (e.g. app les, pee led fruit

- cooked ; fre s h or N/ S; baked ; o r w heat flour

- cooked; fresh or N/ S, ba ked) us ing publicly ava il ab le recipe translation files developed jointly by USDA/ARS an d EPA. For c hronic expos ure assessment , consum pti on data are averaged for the entire U.S

. population a nd w ithin population subgroups , but for acu t e ex posur e assess me nt are retained as individual co n s ump ti on eve nt s . Based o n ana lys is of th e 2003-2008 WWE IA consump tion data , whi c h t oo k into acco un t di etary patterns and survey respondents , H ED concluded that it is mo st appropriate to report risk for the following population subgroups: the ge neral U.S. population , a ll infants ( < l year old) , children 1- 2, children 3-5 , children 6-12, you th 13 -1 9 , adu lts 20-49, females 13-49 , and adults 50

- 99 years old.
For chro ni c dietary exposure assessment , an es tim ate of th e r esid u e leve l in each foo d or foodform (e.g. , 

### o range o r orang e juice) on the food co mm odi ty residue li st is multiplied by the average daily consumption estimate for that food/food form. The resulting res idue consumption est imate for eac h food/food form is s ummed with the residue co nsumption es tim ates for all ot h er food/food forms on the commod ity residue list to arri ve at the tota l average est ima ted exposure. Exposure is exp r essed in mg/kg bo dy wei ght /day and as a percent of the cPAD. This proc edu re 9 of29

### Difenoconazole PC Code : 128847 Dietary Exposure Assessment



### is performed for each population subgroup. DP# : 426491



### For acute exposure assessments, 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 obta in a total daily pesticide exposure for a deterministic exposure assessment , or "matched" in multiple random pairings with residue values and then summed in a probabili stic assessment. The resulting distribution of exposures is expressed as a percentage of the aPAD on both a user 

### (i.e. , those who reported eating relevant commodities/food forms) and a per-capita 

### (i.e. , those who reported eating the relevant commodities as well as those who did not) basis. In accordance with HED policy, per capita exposure and risk are reported fo r a ll tiers of analysis. However, for Tiers 1 and 2 , sign ifi cant differences in user vs. per capita exposure and risk are identified and noted in the risk assessment. VI. Toxicologica l Information 

### On 08-SEP-1998, HED ' s Hazard Identification Assessment Review Committee (HIARC) evaluated the toxicology database of difenoconazole and re-assessed the RID established in 1994 , as well as the toxicological endpoints for the dietary and occupational exposure risk assessments that were selected in 1994

. At this meeting , the HIARC also addressed the potential enhanced sensitivity of infants and children from exposure to difenoconazole as required by the Food Quality Protection Act (FQPA) of 1996 (HED Doc. No. 012873, 25-SEP-1998)

. In July , 2007 , the RAB 1 toxico log ists and risk assessment team met to reevaluate the endpoints selected by the HIARC since new studies were subm itted. RAB 1 tox icologists and ri sk assessment team also reevaluated FQPA assessments
. The risk assessment team concluded that the default lOx FQPA Safety Factor (SF) should be reduced to lx when assessing acute and chronic d ietary exposures (M.Sahafeyan , 0333320 , 09-AUG-07). The relevant endpoints are shown in Table 3. In accordance with HEO ' s current policy and EPA ' s 2005 Cancer Guidelines , difenoconazole is classified as " Suggestive Evidence of Carcinogenic Potential ," based on excessive toxicity observed at the two highest doses, the absence of tumors at the lower doses and the absence of genotoxic effects. A margin

- of

- exposure (MOE) approach in risk assessment was advocated by HED ' s CPRC in 1994. Use of an MOE approach was reviewed and reaffirmed in 2007 by the CPRC Chair (PV Shah , 3/1 / 07, HED Doc. No. 0054532). Therefore , a separate cancer dietary assessment is not being conducted for difenoconazole

.

10 of29

### Di fenoconazole PC Co de: 1 2884 7 Dietary Exposure Assessment DP#: 426491

Table 3. S ummary of Tox icologica l Doses and E ndpoints for Dif e noconazol e for Use in Di eta ry Ri s k Assessme nts. Expos ure Point of Uncertainty / FQPA RID , PAD, for Ri sk Study and R e levant Sce nario Dep art ure Sa fety Factors Assessment Toxicological Effects Acu t e Di etary NOAEL= UF A= IOX aRfD = a PAD = 0.25 Acute Neuro toxicit y S tudy (All 25 UF11 = IOX mg/kg/day in Ra t s popul ation s) m g/k g FQPA SF = IX LOA EL = 2 00 mg/kg in male s b ase d on reduc ed fore-limb grip strength in male s o n day I. 

### Chro ni c NOAEL= UF" = 

### IOX cRID = c PAD = Combi ned chronic Di etary (All 0 .9 6 UF11 = IOX 0.0 Im g/

k

g/day to xic it y/carc in ogen icit y popul ations ) mg/kg/day FQPA SF = IX (rat; di e ta ry) LOAEL = 

### 24.1 / 32.8 mg/kg/day (M/F) based on cumulative decrea ses in body-wei ght gains. Cance r (o ral , Dif e noconazol e is class ified as a Group C. po ss ibl e human carci nogen with a no n-linear (MOE) dem1al. approach for human ri sk characteri zation (C PRC Document , 7/27/94, Me mo. P

. V. Shah dated inhalati on) March 3, 2007, HED Doc. No. 0054532). The c hro ni c dietary expos ure assessment is protec ti ve of ca ncer effects. Point of Departure (PO D) = A data po mt or an estimat ed point th at is derived from observed do se -response data and used to mark th e beg inning of extrapo lation to determine risk a sso ciated with lower environmenta ll y re levant hum an exposures. NOA EL = no observed adverse effect leve l. LOAEL = l owes t observ ed adverse efTect leve l. UF = uncertainty factor. UF,, = extrapolati on from animal to human ( interspec ies). UFn = potential variation in sens iti vity among members of th e human population ( intra specie s)

. FQPA SF = FQPA Safety Factor. P AD = population adjusted dose (a = acu te, c = chronic)

. RID = reference dose.



## VII. R es ults/Discussion
As s tated above , for acute and c hronic asse ss ments , H E D is concerned whe n di eta r y risk excee ds 100% of the aPAD or cPAD , re s pectivel y. T he following paragraph s are summaries of the DEEM -FCID (ve r. 3.16) acute and chroni c exposure analyses

. Acute and chronic aggregate (food+ water) ana lyses were perform ed using DEEM-FCID estimating the di etary expos ure of the 

### U.S. population and various popu lation subgroups. Th e res ult s are summarized 

## in Tables 

## 4 and 

## 5 belo w for acute and chronic ana lyses re s pectivel y . The re s ulting acute food expo s ure est imate s were less tha n HED ' s level of concern ( < 100 % aPAD) at the 95 111 

### percentile of the exposure distribution for general US popu lation ( 15 % aPAD) and a ll population s ub-group s; the most highl y exposed popula t ion s ub g roup wa s All lnfant s < l yea r o ld with 

### 49 % a PAD. The resulting chronic food exposure es timates were les s than H ED's leve l of concern (< I 00% cPAD) for the genera l U.S. population (26 % c PAD) and all popu l ation sub-groups; the most highly exposed population subg r oup was ch il dren 1 -2 years o ld with 89 % cPAD. A separate cancer dietary assessme nt was not conducted for difenoconazole because the cancer N OAEL i s higher than the chronic RID ; therefore , the chronic dietary ri s k es timate i s considered protective of a ll c h ronic effects including carc inoge nicity. 11 of29

### Di fe noco nazo le PC Co de : 128847 Di etary Exp os ure Assessment DP#: 42649 1

Tab l e 4. Su m mary of Acute D ietary (Food p l us Water) Expos u re and Risk for D i fenoconazo l e at the 95th Percenti le. Pop ul ation Subg r oup aPAD (mg/kg/ day) Exposure {mg/kg /da y) % aPAD General 

### U.S. Population 0.03837 1 15 A ll In fa n t s(< I ye ar o ld ) 0.122946 4 9 C hil dren 1- 2 years old 0. 108065 43 C hildren 3 -5 years old 0.074 134 30 0

. 25 Children 6- 12 years old 0.050 1 83 20 Youth 13-19 years old 0.024840 10 Adults 20

- 49 years old 0.026003 10 Adults 50

- 99 years o l d 0.028849 12 Females 13-49 years old 0.025932 10 The bolded %a P AD is th e hi g hest.

Tab l e 5. S u mmary of Chronic Dietary (Fo od plus Water) Exposu r e an d Risk for D i fenocona zo le. Pop ul ation Subgro u p cPAD (mg/kg/ day) Expos u re {mg/kg / day) %c PAD General 

### U.S. Popu l at i

on 0.00259 1 26 All In fa nts(< 1 year o l d) 0.00769 1 77 C hildre n 1 -2 year s old 0.008894 89 Childre n 3-5 years old 0.006043 60 0.0 1 C hildren 6 -1 2 years o l d 0.003709 37 Y

o u th 13 -1 9 years o l d 0.0020 16 20 Ad ul ts 20-49 years o l d 0.00 18 93 19 Adults 50-99 years o l d 0.002095 2 1 Females 13

-49 year s old 0

. 00 185 6 19 The bolded 'Yoc PAD is th e hi g hest.



## VIII. Character ization of Inputs/Outp u ts The acute analys is ass umed tolerance-level re s idues, 100% CT , a nd empirical or DEE M d efault processing factors. The chronic anal ysis assumed tolerance-lev e l re s idue s for so me commodities , average fi e ld trial re s idues and USDA PDP monitoring data for the remainin g commod iti es, average% CT, and empirical or D EEM default proce ss ing factor s . Therefore , these analyses are considered refined. Whil e they cou ld be further refined , further re finement is not warranted as estimated risk s are n ot of conc ern. 

## 12of 29Difenoconazole PC Co de: 128847



### IX. Co nclus ion s Di etary Expos ure Assessme nt DP# : 426491



### An acute aggregate (food + wate r) dietary ri sk assessment wa s conducted for difenoconazo le u si ng the DEEM-FCID Model and assumed toleranc e -level r es idue s, 100 % CT, and e mpiri cal or D EE M default processing fac tors. The chronic aggregate dietary ri sk assessment a ss umed to le rance-l evel res idue s for some commo diti es , average field trial res idues and USDA PDP m o nitorin g data for the re mainin g commoditie s, average% C T , and empirical or DEEM defaul t proce ss ing factors. The resulting acute and chronic aggreg ate exposure estimates were less than H E D 's le ve l of co ncern. For the general U.S. population , the a PAD and cPAD were 15 % and 26 %, resp e ctively. The most hi g hl y-exposed population subgroup in the acute (at the 95 1h 

### percentile ofthe exposure distribution) was All Infant s 

## < l year old (

### 49 % aP

### AD ) and chronic analys i s were children 1-2 years old (89 % cPAO) , respective ly. 

## X . List o f A ttachments Attac hment I: D EEM-FC IO TM Ac ute Re s idu e File At1ac hment 2: D EE M-FCrDTM Acute Ex pos ure Es timate s Attac hment 3: DEE M-FC IDTM C hronic R es idue File Attachment 4: D EEM -FC IDTM C hr o nic Ex posure Estimates Attac hme nt 5 : Pe rcent C rop Treated Memorandum

cc with all attachments: T. Morton ( RABIV) ROI : N. D odd an d 

### I. Encarnac ion

- D ESAC (I 2-March

- 2015); C. S mith ( l-July-2015) Petition Number(s): 4E8274 PC Co de : 12 8847 T

. Morton:S I0838:PY I :(703)305 -66 91



### 1 3 of29

### Di fe noconazole PC Code : 12884 7 

### Dietary Ex po sure Assess m ent


## Attac hment 1: DEEM-FC ID Acute Residue File DP#: 426491

Filename: C:\Users\tmorton\Documents\My F iles\DEE M Files\128847 Difenoconazole\128847 Difenoconazole 4E8 274 M ar 201S\1288 47 Acute Ma r 201S Food and Water.ROS Chemical : Difenoconazole RfD(Chronic) : .01 mg/kg bw/day NOEL(Chron ic): O mg/kg bw/day RfD(Acute) : .2S mg/kg bw/day NOEL(Acute): O mg/kg bw/day Date created/last modified: 03-06-201S/07:02:16 Program ver. 3.16, 03-08-d Crop EPA Code Grp Commodity Name 01010 S2000 lA 01010S2001 lA 01010S3000 lA 01010S3001 lA 0101078000 lAB 0101078001 lAB 0101079000 lAB 0101168000 lAB 010301SOOO lCD 010301S001 lCD 0103017000 lCD 0103082000 lCD 010308200 1 lCD 010313 9000 lCD 010316 6000 lCD 010316 6001 lCD 0103167000 lCD 0103296000 lC 0103297000 lC 0103297001 lC 0103298000 lC 0103298001 lC 0103299000 lC 010329900 1 lC 0103300000 lC 0103 300001 lC 0103366000 lCD 0103366001 lCD 0103371000 lCD 0 1 03387000 lCD 0103406000 lCD 0103407000 lCD 030116SOOO 3A 030116S00 1 3A 0301237000 3A 0301237001 3A 0301238000 3A 030123800 1 3A 0301338000 3A 0302103000 3B 0302 198000 3B 0302239000 3B 0302338SOO 3B OS0 1061000 SA OS0106100 1 SA OS01062000 SA OS01064000 SA OS01069000 SA OS0107 1000 SA OS01072000 SA 0501083000 SA 05011960 00 SA OS02063000 SB OS02070000 SB OS02117000 SB OS0219 4000 SB OS02229000 SB OS02318000 SB OS0 2389000 SB 06003 47000 6 0600349000 6 0600349001 6 0600350000 6 06003S0001 6 0601349S00 6AB Beet, sugar Beet, sugar-babyfood Beet, sugar, molasses Beet, sugar, molasses-babyfood Carrot Carrot

- babyfood Carrot, juice Ginseng, dried Arrowroot, flour Arrowroot, flour-babyfood Artichoke, Jerusalem Cassava Cassava-babyfood Dasheen, corm Ginger Ginger-babyfood Ginger, dried Potato, chips Potato, dry (granul es / flak es) Potato, dry (granules/ flakes )-b Potato, flour Potato, flour-babyfoo d Potato, tuber, w/peel Potato, tuber, w / peel-baby food Potato, tuber, w/o peel Potato, tuber, w/o peel -babyfood Sweet potato Sweet potato-babyfood Tanier, corm Turmeric Yam, true Yam bean Garlic, bulb Garlic, bulb-babyfood Onion, bulb Onion, bulb

- babyfood Onion, bulb, dried Onion, bulb, dried-babyfood Shallot, bulb Chive, fresh leaves Leek Onion, green Shallot, fresh le aves Broccoli Broccoli-babyfood Broccoli, Chinese Brussels sprouts cabbage Cabbage, Chinese , napa Cabbage, Chinese , mustard Cauliflower Kohlrabi Broccoli raab Cabbage, Chinese, bok choy Collards Kale Mustard greens Rape greens Turnip, greens soybean, seed Soybean, soy milk Soybean, soy milk-babyfood or in Soybean, oil soybean, oil-b abyfood Soybean, vegetable Def Res ( ppm ) 0.300000 0.300000 0.300000 0.300000 0.500000 

### o .sooooo 0.500000 1.000000 4.000000 4.000000 4.000000 4.000000 4.000000 4.000000 4.000000 4.000000 4.000000 4.000000 4.000000 4.000000 4.000000 4.000000 4.000000 4. 000000 4.000000 4.000000 4.000000 4.000000 4.000000 4.000000 4.000000 4.000000 0 .200000 0.200000 0.200000 0.200000 0.200000 0 .200000 0.200000 6.000000 6.000000 6.000000 6.000000 1.900000 1.900000 1.900000 1. 900000 1.900000 1.900000 1

. 900000 1.900000 1.900000 3S.OOOOOO 3S.OOOOOO 3S

. 000000 3S.OOOOOO 35.000000 )S.000000 3S.OOOOOO

O.lSOOOO 0.150000 0 .150000 0.150000 0.150000 0.150000 

## 14 o f29 Adj.Factors #1 #2 1.000 1. 000 0

. 600 0

. 600 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 

### o.soo 0

. 500 0

. 500 

### o . soo 0.500 1

. 000 1.000 1.000 1 .0 00 1. 000 1.000 1.000 1

. 000 1.000 1. 000 1

. 000 1

. 000 1.000 1.000 9

. 000 9.000 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 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 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 1. 000 1.000 1.000 Comment

### Difenoconazole Dietary Expos ure Assessment DPll: 426491 PC Co de: 128847
0603030000 6C Bean, black, seed 0.200000 l.000 1.000 0603032000 6C Bean, broad, seed 0.200000 1. 000 l. 000 0603034000 6C Bean, cowpea, seed 0.200000 1.000 l. 000 0603035000 6C Bean, great northern, seed 0

. 200000 1. 000 l. 000 0603036000 6C Bean, kidney, seed 0

. 200000 1.000 l.000 060303SOOO 6C Bean, lima, seed 0.200000 1. 000 1 .000 0603039000 6C Bean , mung, see d 0 .2 00000 1

. 000 1 .000 0603040000 6C Bean, navy , see d 0

. 200000 1. 000 1

. 00 0 0603041000 6C Bean, pink, seed 0.200000 l. 000 l. 000 0603042000 6C Bean, pinto, seed 0.200000 l. 000 l

. 000 060309SOOO 6C Chickpe a. seed 0.200000 1. 000 l.000 060309SOOl 6C Chickpe a, seed-babyfood 0

. 200000 l. 000 l .000 0603099000 6C Chickp ea, flour 0

. 200000 l

. 000 l. 000 06031S2000 6C Guar

. seed 0.200000 l. 000 1.00 0 06031S2001 6C Guar. seed-baby food 0.200000 l. 000 1.000 0603203000 6C Lentil, seed 0.200000 l. 000 1.000 0603256000 6C Pea, dry 0.200000 l

. 000 1.000 0603256001 6C Pea, dry-babyfood 0.200000 1. 000 l. 000 060325SOOO 6C Pea, pigeon, seed 0.200000 l. 000 1.000 060334SOOO 6C Soybean, fl our 0

. 150000 l. 000 l. 000 060334S001 6C Soybean, fl our-babyfood 0.150000 1. 000 l. 000 OS01374000 SA Tomatillo 0 .6 00000 1. 000 l. 000 OS01375000 SA Tomato 0.600000 1. 000 1. 000 OS01375001 SA Tomato -babyfood 0

. 600000 l. 000 l. 000 OS01376000 SA Tomato, pas te 0.600000 1

. 600 l. 000 OS01376001 SA Tomato, pas te-babyfood 0

. 600000 1. 600 1.000 OS01377000 SA Tomato , puree 0

. 600000 0.500 l .000 OS01377001 SA Tomato, puree-babyfood 0 .600000 0.50 0 1 .000 OS0137SOOO SA Tomato, dri e d 0

. 600000 14. 300 l. 000 OS0137S001 SA Tomato, dried-babyfood 0.600000 14.3 00 1.000 OS01379000 SA Tomato, juice 0.600000 l. 500 1.000 OS013SOOOO SA Tomato, Tree 0.600000 1.000 1

. 000 OS0214SOOO SBC Eggplan t 0

. 600000 1. 000 l. 000 OS02234000 SBC Okra 0 .6 00000 1. 000 1 .000 OS02270000 SB Pepper , bell 0

. 600000 1.0 00 1 .000 OS0227000 1 SB Pepper, be 11- baby food 0.600000 1.00 0 1 .000 OS02271000 SB Peppe r, bell , dried 0.600000 1.000 l. 000 OS02271001 SB Pepper, bell, dried-bab y food 0.600000 1.000 l. 000 OS02272000 SBC Pepper, nonbell 0

. 600000 l. 000 1.000 OS02272001 SBC Pepper, nonbell-babyfood 0.600000 1.000 1.000 OS02273000 SBC Pepper, nonb ell, dried 0.600000 1. 000 1.000 0901075000 9A Cantalo upe 0.700000 1.00 0 l. 000 09011S7000 9A Honeydew me lon 0.700000 1. 000 l. 000 0901399000 9A watermelon 0.700000 l. 000 l. 000 0901400000 9A watermelon, juice 0.700000 l. 000 1.000 0902021000 9B Balsam pear 0

. 700000 l. 000 1

. 000 0902088000 9B Chayote, fruit 0.700000 1.000 1. 000 0902102000 9B Chines e waxgourd 0.700000 1. 000 1. 000 0902135000 9B Cucumber 0

. 700000 1. 000 1

. 000 0902308000 9B Pumpkin 0.700000 l. 000 1.000 0902309000 9B Pumpkin, seed 0

. 700000 1

. 000 1

. 000 0902356000 9B squash, summer 0.700000 1. 000 1.000 0902356001 9B Squash, summer-babyfood 0.700000 1

. 000 1.000 0902357000 9B Squash, winter 0.700000 l. 000 1

. 000 0902357001 9B squash, winter

- babyfood 0

. 700000 1.000 1.000 1001106000 lOA Citron 0.600000 1.000 1

. 000 1 001107000 lOA Citrus h ybrids 0

. 600000 1. 000 1.000 lOOllOSOOO lOA Citrus, oil 25.000000 1. 000 1 .0 00 1001240000 lOA Orange 0.600000 1. 000 1.000 1001241000 lOA orange, juice 0

. 600000 0.100 1.000 1001241001 lOA orange, juice-babyfood 0.600000 0.100 1.000 1001242000 lOA Orange, pee l 0.600000 1.000 1.000 1001369000 lOA Tange rine 0.600000 l. 000 1.000 1001370000 l OA Tangeri ne, j u ice 0

. 600000 0

. 100 1.000 1002197000 lOB Kumquat 0 .6 00000 1. 000 1. 000 1002199000 lOB Lemon 0.600000 1.000 1. 000 1002200000 lOB Lemon, juice 0.600000 0.100 1.000 1002200001 lOB Lemon, juice-babyfoo d 0.600000 0.100 1.000 1002201000 lOB Lemon, peel 0.600000 1.000 1. 000 1002206000 lOB Lime 0.600000 1. 000 1 .000 1002207000 l OB Lime

. juice 0.600000 0.100 1. 000 1002207001 108 Lime, juice

- b abyfood 0.600000 0 .1 00 l .000 10031SOOOO lO C Grapefruit 0.600000 1. 000 1. 000 10031Sl000 lOC Grapefruit, juice 0.600000 0.100 1. 000 1003307000 lOC Pummelo 0.600000 1.000 1.000 1100007000 11 Apple, fruit with peel 5.000000 l. 000 1

. 000 llOOOOSOOO 11 Apple, peel ed fruit 5.000000 l.00 0 1.000 1100008001 11 Apple , p ee l e d fruit-babyfood 5

. 000000 1.0 00 1

. 000 

### 15 of29

### Dife noco nazo l e Dieta ry Ex pos ure Assess m ent DP# : 42 6491 PC Code: 1 28847
1100009000 11 Apple, dried 5.000000 8.000 1.000 1100009001 11 Apple, dried-babyfood 5.000000 8.000 1. 000 1100010000 11 Apple, juice 5.000000 0.040 1. 000 1100010001 11 Apple, juice-babyfo od 5.000000 0.0 4 0 1. 000 1100011000 11 Apple, sauce 5.000000 1.000 1.000 1100011001 11 Apple, sauce-babyfood 5.000000 1.000 1.000 1100129000 11 Crabapple 5.000000 1.000 1.000 1100173500 11 Goji berry 5.000000 1.000 1.000 1100210000 11 Loquat 5.000000 1.000 1.000 1100266000 11 Pear 5.000000 1.000 1

. 000 1100266001 11 Pear-babyfood 5.000000 1.000 1.000 1100267000 11 Pear, dried 5.000000 6.250 1.000 1100268000 11 Pear, juice 5.000000 1.000 1.000 1100268001 11 Pear, juice -babyfood 5.000000 1.000 1.000 1100310000 11 Quince 5.000000 1. 000 1.000 1201090000 12A Cherry 2.500000 1. 000 1.000 1201090001 12A Cherry-babyfood 2.500000 1. 000 1. 000 1201091000 12A Cherry, juice 2.500000 1. 500 1. 000 1201091001 12A Cherry, juice-babyfood 2.500000 1.500 1. 000 1202012000 12B Apricot 2.500000 1. 000 1. 000 1202012001 12B Apricot-babyfood 2.500000 1. 000 1. 000 1202013000 126 Apricot, dried 2.500000 6.000 1. 000 1202014000 12B Apricot, juice 2.500000 1. 000 1. 000 1202014001 12B Apricot, juice-babyfood 2.500000 1. 000 1.000 1202230000 126 Nectarine 2.500000 1. 000 1.000 1202260000 126 Peach 2.500000 1. 000 1.000 1202260001 126 Peach-babyfood 2.500000 1 .000 1.000 1202261000 12B Peach, dried 2.500000 7.000 1. 000 1202261001 126 Peach, dried-babyfood 2.500000 7.000 1.000 1202262000 12B Peach, juice 2.500000 1.000 1.000 1202262001 12B Peach, juice-babyfood 2.500000 1.000 1. 000 1203285000 12C Plum 2.500000 1.000 1.000 1203285001 12C Plum-babyfood 2.500000 1.000 1.000 1203286000 12C Plum, prune, fresh 2.500000 1.000 1.000 1203286001 12C Plum, prune, fresh-babyfood 2.500000 1.000 1.000 1203287000 12C Plum, prune, dried 2.500000 5.000 1. 000 1203287001 12C Plum, prune , dried

- babyfood 2.500000 5.000 1.000 1203288000 12C Plum, prune, juice 2.500000 1.400 1. 000 1203288001 12C Plum, prune, juice-babyfood 2.500000 1

. 400 1.000 1302057000 13B Blueberry 4.000000 1. 000 1. 000 1302057001 13B Blueberry-babyfood 4.000000 1.000 1.000 1302136000 13B curra nt 4.000000 1. 000 1. 000 1302137000 13B Currant, dried 4.000000 1. 000 1. 000 1302149000 13B Elderberry 4.000000 1. 000 1. 000 1302174000 13B Gooseberry 4.000000 1. 000 1.000 1302191000 13B Huckleberry 4.000000 1. 000 1. 000 13 04175000 130 Grape 4.000000 1. 000 1. 000 1304176000 130 Grape, juice 4.000000 0.200 1. 000 1304176001 130 Grape, juice-babyfood 4.000000 0.200 1. 000 1304179000 130 Grape, wine and s h erry 4.000000 1. 000 1. 000 1307130000 13G Cranberry 4.000000 1. 000 1. 000 1307130001 13G Cranberry-babyfood 4.000000 1. 000 1.000 1307131000 13G Cranberry, dried 4.000000 1. 000 1.000 1307132000 13G Cranberry, juice 4.000000 1.100 1. 000 1307132001 13G Cranberry, juice-babyfood 4.000000 1.100 1.000 1307359000 13G Strawberry 2.500000 1.000 1.000 1307359001 13G Strawberry -babyfood 2.500000 1. 000 1.000 1307360000 13G Strawberry, juice 2.500000 1. 000 1.000 1307360001 13G Strawberry, juice-babyfood 2.500000 1.000 1.000 1400003000 1 4 Almond 0.030000 1.000 1.000 1400003001 14 Almond-baby food 0.030000 1.000 1.000 14 00004 000 14 Almond, oil 0.030000 1.000 1.000 1400004001 14 Almond, oil-babyfood 0.030000 1.000 1.000 1400059000 14 Brazil nut 0.030000 1.000 1.000 1400068000 1 4 Butternut 0.030000 1. 000 1.000 1400081000 14 Cashew 0.030000 1.000 1.000 14 00092000 14 Chestnut 0.030000 1.000 1. 000 1400155000 14 Hazelnut 0.030000 1. 000 1. 000 1400156000 14 Hazelnut, oil 0.030000 1. 000 1. 000 1400185000 14 Hickory nut 0

. 030000 1.000 1. 000 1400213000 14 Macadamia nut 0

. 030000 1. 000 1. 000 1400269000 14 Pecan 0.030000 1. 000 1. 000 1400278000 14 Pine nut 0 .030000 1. 000 1.000 14 00282000 14 Pistachio 0.030000 1. 000 1.000 1400391000 14 walnut 0.030000 1. 000 1. 000 1500025000 15 Barley, pearled barley 0.100000 1.000 1. 000 1500025001 15 Barley, pearled barley

- babyfood 0.100000 1. 000 1. 000 1500026000 15 Barley, flour 0.100000 1. 000 1. 000 

## 16 of 2 9

### Di fe noco n azo le Di etary Exp os ure Assess ment OP #: 42649 1 PC Code: 12 8 847
1500026001 15 Barley, flour

- babyfood 0.100000 1. 000 1. 000 1500027000 15 Barley, bran 0.100000 1. 000 1. 000 1500127000 15 Corn, sweet 0

. 0 1 0000 1. 000 1

. 000 1500127001 15 Corn, sweet-babyfood 0.010000 1.000 1. 000 1500231000 15 Oat, bran 0.010000 1.000 1. 000 1500232000 15 Oat, flour 0.010000 1. 000 1.000 1500232001 15 Oat, flour-babyfood 0.010000 1.000 1.000 1500233000 15 Oat, groats/rolled oats 0.010000 1. 000 1.000 1500233001 15 Oat, groats/rolled oats-babyfood 0.010000 1. 000 1.000 1500328000 15 Rye, grain 0.010000 1. 000 1. 000 1500329000 15 Rye, flour 0.010000 1.000 1.000 1500381000 15 Triticale, flour 0.100000 1.000 1.000 1500381001 15 Triticale, flour-baby food 0.100000 1. 000 1.000 1500401000 15 wheat, grain 0.100000 1.000 1.000 1500401001 15 Wheat, grain-babyfood 0.100000 1.000 1. 000 1500402000 15 Wheat, flour 0.100000 l.000 1. 000 1500402001 15 Wheat, flour-baby food 0.100000 1.000 1. 000 1500403000 15 Wheat, germ 0.100000 1. 000 1.000 1500404000 15 Wheat, bran 0.100000 1. 000 1.000 2001163000 20A Flax seed, oil 0.100000 l.000 1. 000 2001319000 20A Rapeseed, oil 0.100000 1. 000 1. 000 2001319001 20A Rapeseed, oil-babyfood 0.100000 l. 000 1. 000 2001336000 20A Sesame, seed 0.100000 l. 000 1. 000 2001336001 20A Sesame, seed-babyfood 0.100000 1.000 1. 000 2001337000 20A Sesame, oil 0.100000 1. 000 1. 000 2001337001 20A Sesame, oil-babyfood 0.100000 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 3100044000 31 Beef, meat 0.050000 1.000 1.000 3100044001 31 Beef, meat

- babyfood 0.050000 1. 000 l. 000 3100045000 31 Beef, meat, dried 0.050000 l. 920 1. 000 3100046000 31 Beef. meat byproducts 0.100000 l. 000 1.000 3100046001 31 Beef, meat byproducts-babyfood 0.100000 1. 000 1.000 3100047000 31 Beef. fat 0.100000 l.000 l. 000 3100047001 31 Beef. fat-babyfood 0.100000 1. 000 1

. 000 3100048000 31 Beef, kidney 0.100000 1. 000 1.000 3100049000 31 Beef, liver 0.400000 1. 000 1.000 3100049001 31 Beef. liver-babyfood 0.400000 1.000 1.000 3200169000 32 Goat, meat 0.050000 1. 000 1.000 3200170000 32 Goat, meat byproducts 0.100000 1.000 1.000 3200171000 32 Goat, fat 0.100000 1. 000 1.000 3200172000 32 Goat, kidney 0.100000 1. 000 1. 000 3200173000 32 Goat, liver 0.400000 l. 000 1.000 3300189000 33 Horse, meat 0.050000 l. 000 l. 000 3400290000 34 Pork, meat 0.050000 1.000 1.000 3400290001 34 Pork, meat

- babyfood 0.050000 1. 000 1

. 000 3400291000 34 Pork, skin 0.100000 l. 000 1.000 3400292000 34 Pork, meat byproducts 0.100000 1. 000 1.000 3400292001 34 Pork. meat byproducts-babyfood 0.100000 1.000 1

. 000 3400293000 34 Pork, fat 0.100000 1. 000 1.000 3400293001 34 Pork, fat-babyfood 0.100000 l. 000 1.000 34 00294 000 34 Pork, kidney 0.100000 l. 000 1. 000 3400295000 34 Pork. liver 0. 400000 1.000 1. 000 3500339000 35 Sheep, meat 0.050000 1.000 1.000 3500339001 35 Sheep, meat-babyfood 0.050000 1. 000 1.000 3500340000 35 Sheep, meat byproducts 0.100000 1.000 l. 000 3500341000 35 Sheep, fat 0.100000 1. 000 1.000 3500341001 35 Sheep, fat

- babyfood 0.100000 1.000 1.000 3500342000 35 Sheep, kidney 0.100000 1.000 1. 000 3500343000 35 Sheep, liver 0. 400000 1.000 1. 000 3600222000 36 Milk, fat 0.020000 1. 000 1.000 3600222001 36 Milk, fat-baby food / infant formu 0.020000 1.000 1. 000 3600223000 36 Milk, nonfat solids 0.020000 1. 000 1.000 3600223001 36 Milk, nonfat solids-baby food/in 0.020000 1. 000 1.000 3600224000 36 Milk, water 0.020000 1. 000 1.000 3600224001 36 Milk, water-babyfood/infant form 0.020000 1. 000 l. 000 3600225001 36 Milk, sugar (lactose)-baby food/ 0.020000 1. 000 1.000 7000145000 70 Egg, whole 0.020000 1. 000 l. 000 7000145001 70 Egg, whole-babyfood 0.020000 1.000 1.000 7000146000 70 Egg, white 0.020000 1.000 1.000 7000146001 70 Egg, white (solidsJ- b abyfood 0.020000 1.000 1.000 7000147000 70 Egg, yolk 0.020000 l. 000 1.000 7000147001 70 Egg, yolk-babyfood 0.020000 1.000 1. 000 8601000000 86A Water, direct, all sources 0.020000 1. 000 1. 000 8602000000 86B Water, indirect, all sources 0.020000 1. 000 1.000 9500016000 0 Artichoke, globe 1.500000 1. 000 1.000 9500023000 0 Banana 0.200000 l. 000 1. 000 9500023001 0 Banana-babyfood 0.200000 l. 000 1. 000 

### 17 o f 29

### Di fc noco nazo le Dietar y E xpos ure Assessment DP# : 426491 PC Code: 1 28847

9500024000 0 Banana, dried 0.200000 3.900 1.000 9500024001 0 Banana, dried-babyfood 0.200000 3.900 1.000 9500177000 0 Grape, leaves 4.000000 1.000 1.000 9500178000 0 Grape, raisin 6.000000 1.000 1.000 9500215000 0 Mango 0

. 070000 1.000 1.000 9500215001 0 Mango-babyfood 0

. 070000 1.000 1. 000 9500216000 0 Mango, dried 0.070000 1.000 1. 000 9500217000 0 Mango, juice 0.070000 1.000 1

. 000 9500217001 0 Mango. juice- babyfood 0

. 070000 1.000 1. 000 9500245000 0 Papaya 0.300000 1. 000 1. 000 95002 4 5001 0 Papaya-babyfood 0.300000 1.000 1. 000 9500246000 0 Papaya, dr ie d 0.300000 1. 800 1. 000 9500247000 0 Papaya, juice 0.300000 1.500 1. 000 9500283000 0 Plantain 0

. 200000 1. 000 1.000 9500284000 0 Plantain, dried 0.200000 3 .900 1.000



## 18 of 29

### Difenoconazole 

### P

C Cod e: 128847 Dietary Exposure Asse ss ment 

### DP #: 42649 1



### Attac hm ent 2: D EEM -FCID A cute E xpo s ure Es timates

US EPA OEEM-FCIO ACUTE Analysis for OIFENOCONAZOLE ver. 3

. 18, 03-08-d NHANES 2003-2008 2-Day Residue file: 128847 Acute Mar 2015 Food and Water.ROS Adjustment factor #2 used. Analysis Date: 04-14-2015/07:17:06 RAC/FF intake summed over 24 hours Run Comment: ""
Summary calculations--per capita: 95th Percentile Exposure \ aRfD



### ---------- ------ -- Total us Population: 0.038371 15. 35 All Infants: 0.122946 49. 1 8 Children 1-2: 0.108065 43

. 23 Children 3-5: 0.074134 29.65 Children 6-12 : 0 .050183 20.07 Youth 13-19: 0.024840 9. 94 Adults 20-49: 0

. 026003 10 .4 0 Adults 50-99: 0.028849 11. 54 Female 13-49: 0.025932 10. 37



### FO OD ONLY

US EPA Residue file dated : 04-14-2015/07:12:29

99th Percen tile 99.9th Percentile Exposure 

# ' aRfD Exposure 

# ' aRfD



### ------- - -- ----- --- 

## ----- --- -- --------

0.080320 32.13 0.159182 63.67 0.188019 75.21 0 .266271 106

. 51 0.167396 66 .96 0.407 44 1 162 .98 0 .120179 48

. 07 0.230086 92

. 03 0.084207 33.68 0 .145216 58.09 0.043253 17. 30 0.121941 48.78 0.044454 17.78 0.102906 41.16 0.058188 23

. 28 0.127083 50.83 0.044352 17.74 0.102615 41. 05

DEEM-FCID ACUTE Analysis for DIFENOCONAZOLE Residue file: 128847 Acute Mar 2015 Food Only.ROB Ver. 3.18, 03-08-d NHANES 2003-2008 2-Day Adjustment factor #2 used. dated : 04-14-2015/07:11:38 Analysis Date: 04-14-2015/07:41:27 Residue file RAC/FF intake summed over 24 hours Run Comment: ""
Summary calculat ions --per capita: 95th Percentile 99th Percentile 99.9th Percentile Exposure 

# ' aRfD Exposure 

# ' aRfD Exposure 

# ' aRfD



### ------ - - -- 

## ----- --- ------- - -- 

## -------- 

# ------···- 

# ----·--- Total us Population: 0.0378 64 15.15 0.079985 31. 99 0.15 8254 63

. 30 All Infants: 0.121522 48.61 0 .185721 74

. 29 0.265664 106

. 27 Children 1-2: 0.107552 43 .02 0.166250 66

. 50 0. 404915 161.97 Children 3

- 5: 0

. 0736 11 29

. 44 0. 118936 47.57 0.228458 91. 3 8 Children 6-12: 0. 049833 19.93 0.083 109 33.24 0.145 147 58

. 06 Youth 13-19: 0. 024462 9.78 0.042645 17.06 0.121769 48. 71 Adults 20-49: 0.0253 81 10.15 0.043966 17.59 0

. 102720 41. 09 Adults 50-99: 0.028263 11. 31 0 .057725 23 .09 0 .126771 50

. 71 Female 13 -4 9: 0.025437 10.17 0.043864 17.55 0.102467 40

. 99


## 19 of29

### Difenoco nazol e P

C Code: 12 88 4 7 Di etary Ex pos ure Assess m ent



### Attachment 3: D EE M-F C ID Chron ic Res idue Fi le DP #: 4264 91

Filename: C:\Users\tmorton\Do cuments \ My Files\DEEM Files\128847 Difenoconaz ole\ 128847 Difenoconazole 4£8274 Mar 2015\1288 4 7Chronic Mar 2015 Food and water.ROS Chemical: Difenoconazo le RfD{Chronic) : .01 mg/kg bw/day NOEL(Chronic): O mg /kg bw/day RfD(Acute): .25 mg/kg bw/day NOEL(Acute): O mg/kg bw/day Date created/last modified: 04-l4-201S/06:Sl:34 Program ver. 3.16, 03-08-d Crop EPA Code Grp Commodity Name Def Res (ppm) 01010S2000 lA 01010S200 1 lA 01010S3000 lA 01010S3001 lA 0101078000 lAB 0101078001 lAB 0101079000 lAB 0101168000 lAB 010301SOOO lCD 010301S001 lCD 0103017000 lCD 0103082000 lCD 0103082001 lCD 0103139000 lCD 0103166000 lCD 0103166001

. lCD 0103167000 lCD 010329 6000 lC 0103297000 lC 0103297001 lC 0103298000 lC 0103298001 lC 0103299000 lC 0103299001 lC 0103300000 lC 0103300001 lC 0103366000 lCD 0103366001 lCD 0103371000 lCD 0103387000 lCD 0103406000 lCD 0103407000 lCD 030116SOOO 3A 030116S001 3A 0301237000 3A 0301237001 3A 0301238000 3A 0301238001 3A 0301338000 3A 0302103000 3B 0302198000 3B 0302239000 3B 0302338SOO 3B OS01061000 SA OS01061001 SA OS01062000 SA OS01064000 SA OS01069000 SA OS01071000 SA OS01072000 SA 0S01083000 SA 0S01196000 SA OS02063000 SB OS02070000 SB OS02117000 SB OS02194000 SB OS02229000 SB OS02318000 SB OS02389000 SB 06003 47000 6 0600349000 6 06003 49001 6 06003SOOOO 6 06003S0001 6 0601349SOO 6AB Beet, sugar Beet, sugar-babyfood Beet, sugar, molasses Beet. sugar, molasses-babyfood Carrot Carrot

- babyfood Carrot. juice Ginseng, dried Arrowroot. flour Arrowroot, flour-babyfood Art ichoke, Jerusalem cassava Cassava-babyfood Dasheen, corm Ginger Ginger

- baby food Ginger, dried Potato, chips Potato, dry (granules/ flakes) Potato, dry (granu l es/ flakes)

- b Potato, flour Potato, flour-babyfood Potato. tuber, w/peel Potato. tuber, w / peel

- babyfood Potato, tuber. w /o peel Potato, tuber. w /o peel

- babyfood Sweet potato Sweet potato-babyfood Tanier, corm Turmeric Yam, true Yam bean Garlic, bulb Garlic, bulb-babyfood Onion, bulb Onion, bulb-babyfood Onion, bulb. dried Onion, bulb, dried-babyfood Shallot. bulb Chive. fresh leaves Leek Onion, green Shallot, fresh leaves Brocc oli Brocc oli-babyfoo d Brocc oli, Chinese Brussels sprouts Cabbage Cabbage. Chinese. napa Cabbage, Chinese. mustard Cauliflower Kohlrabi Broccoli raab Cabbage. Chinese, bok choy Collards Kale Musta rd greens Rape greens Turnip, greens soybean, seed Soybean, soy milk Soybean, soy milk-babyfood or i n Soybean, oil Soybean, oil-babyfood Soybean, vegetable 0.300000 0. 300000 0.300000 0.300000 0.007000 0.007000 0.007000 0.316000 1.360000 1.360000 1.360000 1.360000 1 .36 0000 1 .36 0000 1.360000 1. 360000 1. 3 60000 1.360000 1. 360000 l.360000 1.360000 1.360000 1.360000 1.360000 1.360000 1.360000 1.360000 1.360000 1.360000 1

. 360000 1 .36 0000 1.360000 0.002SOO 0.002SOO 0.002SOO 0.002SOO 0.002SOO 0.002SOO 0.002S00 6.000000 6.000000 6.000000 6.000000 0.019000 0.019000 0.019000 0.029000 0.029000 0.029000 0.003000 0.003000 0.029000 5.100000 5.100000 S.100000 S .100000 S.100000 5.100000 S.100000 0.02 1SOO 0.021SOO 0.021SOO 0.021SOO 0.021SOO 0.021500 

## 20 o f 2 9 Adj.Factors #1 112 1.000 1.000 0.600 0.600 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 

### o.soo o.soo o . soo 0.500 

### o . soo 1

. 000 1.000 1.000 1.000 1. 000 1.0 00 1.000 1.000 1.000 1.000 1.000 1.000 1.000 1.000 9

. 000 9

. 000 1. 000 1. 000 1.000 1. 000 1.00 0 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 1.0 00 1.000 1.000 1.000 1.000 1.000 1. 000 1

. 000 1

. 000 0

. lSO O.lSO 0.150 0.150 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 1.00 0 1. 000 1.000 1.000 1.000 1.000 1.000 1.000 1.000 

### o.oso o.oso o.oso o.oso 0.050 

### o.oso 1.000 1. 000 1.000 1.000 1.000 1.000 1.000 1.000 1.000 0.025 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 CommentDifeno co nazole Di etary E xpo s ure A ssess ment DP# : 4 2 6491 PC Co de: 12 884 7
0603030000 6C Bean, black, seed 0.014000 1.000 l. 000 0603032000 6C Bean, broad, seed 0

. 014000 1

. 000 1

. 000 0603034000 6C Bean, cowpea, seed 0.014000 1.000 1. 000 0603035000 6C Bean, great northern, seed 0. 014000 1.000 1.000 0603036000 6C Bean, kidney, seed 0.014000 1.000 1. 000 060303SOOO 6C Bean, lima, seed 0.014000 l. 000 1 .000 0603039000 6C Bea n , mung, seed 0.014000 l. 000 1. 000 0603040000 6C Bean, navy, seed 0.014000 1.000 l. 000 0603041000 6C Bean, pink, seed 0.014000 1.000 1. 000 0603042000 6C Bean, pinto, seed 0. 014 000 1.000 l. 000 060309SOOO 6C Chickpea, seed 0

. 014000 1.000 1

. 000 060309S001 6C Chic k pea, seed-babyfood 0

. 014000 1. 000 1. 000 0603099000 6C Chickpea, flour 0.014000 1.000 1. 000 06031S2000 6C Guar, seed 0.014000 1.000 1. 000 06031S2001 6C Guar, seed-baby food 0.014000 1.000 l. 000 0603203000 6C Lentil, see d 0

. 014000 1

. 000 1

. 000 0603256000 6C Pea, dry 0.034000 1.000 1. 000 0603256001 6C Pea, dry-baby food 0.034000 1.000 1. 000 060325SOOO 6C Pea, pigeon, seed 0. 034000 1.000 l. 000 060334SOOO 6C Soybean, flour 0

. 021500 1.000 l. 000 060334S001 6C Soybean, flour-babyfood 0

. 021500 1. 000 l. 000 OS01374000 SA Tomatillo 0.165000 1.000 1.000 OS01375000 SA Tomato 0

. 165000 1.000 0

. 250 OS01375001 SA Tomato-babyfood 0.165000 1. 000 0.250 OS01376000 SA Tomato, paste 0.165000 1. 600 0

. 250 OS01376001 SA Tomato, paste-babyfood 0. 1 65000 1 .600 0

. 250 OS01377000 SA Tomato, puree 0

. 165000 0.500 0

. 250 OS01377001 SA Tomato, puree-babyfood 0

. 165000 0.500 0.250 OS0137SOOO SA Tomato, dried 0

. 165000 14. 300 0.250 OS0137S001 SA Tomato, dried-babyfood 0

. 165000 14. 300 0

. 250 OS01379000 SA Tomato, jui ce 0

. 165000 1

. 500 0

. 250 OS013SOOOO SA Tomato, Tree 0

. 165000 1.000 l. 000 OS0214 sooo SBC Eggplant 0 .133000 1.000 1

. 000 OS02234000 BBC Okra 0.600000 1.000 l. 000 OS02270000 BB Pepper, bell 0

. 133000 1.000 0

. 025 OS02270001 BB Pepper, be ll -babyfood 0

. 133000 1.000 0

. 025 OS02271000 SB Pepper, bell, dried 0.133000 1.000 0.025 OS02271001 SB Pepper, bell, dried-babyfood 0.133000 1.000 0

. 025 OS02272000 SBC Pepper, nonbell 0

. 133000 1.000 0

. 025 OS02272001 SBC Pepper, nonbell-babyfood 0

. 133000 1.000 0

. 025 OS02273000 SBC Pepper, nonbell, dried 0.133000 1.000 0

. 025 0901075000 9A Cantaloupe 0.002500 l. 000 0.025 09011S7000 9A Honeydew melon 0.002500 1.000 1

. 000 0901399000 9A Watermelon 0.002500 1.000 0

. 050 0901400000 9A Wa t ermelon, juice 0

. 002500 1. 000 0

. 050 0902021000 9B Balsam pear 0.055000 1.000 l. 000 09020SSOOO 9B Chayote, fruit 0.012000 l. 000 1.000 0902102000 9B Chinese waxgourd 0

. 055000 1.000 1

. 000 0902135000 9B cucumber 0.055000 l. 000 0

. 050 090230SOOO 9B Pumpkin 0.012000 1

. 000 0.025 0902309000 9B Pumpkin, seed 0.012000 1. 000 0.025 0902356000 9B Squash, summer 0.012000 l. 000 0

. 050 0902356001 9B Squash. summer-babyfood 0.012000 1

. 000 0

. 050 0902357000 9B Squash, winter 0.012000 1. 000 0

. 050 0902357001 9B Squash, win t er-babyfood 0.012000 1. 000 0.050 1001106000 lOA Citron 0.005000 1. 000 1. 000 1001107000 lOA Citrus hybrids 0.005000 1.000 1. 000 100110SOOO lOA Citrus, oil 25.000000 1. 000 1. 000 1001240000 lOA Orange 0.005000 1. 000 0.025 1001241000 lOA Orange, juice 0.005000 0.100 0

. 025 1001241001 lOA Orange, juice-babyfood 0.005000 0.100 0

. 025 1001242000 lOA Orange, peel 0.005000 1.000 0.025 1001369000 lOA Tangerine 0.005000 1.000 0.025 1001370000 lOA Tangerine, juice 0

. 005000 0

. 100 0

. 025 1002197000 lOB Kumquat 0.005000 l. 000 1.000 1002199000 lOB Lemon 0.005000 1.000 1.000 1002200000 lOB Lemon, juice 0.005000 0.100 1.000 1002200001 lOB Lemon, juice-baby food 0.005000 0

. 100 1

. 000 1002201000 lOB Lemon, pee l 0

. 005000 1.000 1. 000 1002206000 lOB Lime 0.005000 1.000 1.000 1002207000 lOB Lime, juice 0.005000 0.100 1

. 000 1002207001 lOB Lime, juice-babyfood 0.005000 0.100 1.000 10031SOOOO lOC Grapefruit 0

. 005000 1.000 0

. 025 10031Sl000 lOC Grap efruit, juice 0.005000 0.100 0.025 1003307000 lOC Pummelo 0.005000 1.000 1. 000 1100007000 11 Apple, fruit with peel l. 4 20000 1.000 1. 000 llOOOOSOOO 11 Apple, peeled fruit 1.420000 1.000 l. 000 llOOOOSOOl 11 Apple, peel e d fruit-babyfood 1. 4 20000 1. 000 1. 000 

### 21 

## of 29

### Di fe noco nazole Di etary Expos ure Assess m ent DP#: 42 6491 P

C Co d e: 1 2 88 47

1100009000 11 Apple, dried l.420000 8.000 1.000 1100009001 11 Apple, dried-baby food 1. 420000 8.000 1.000 1100010000 11 Apple, juice 1

. 420000 0

. 040 1.000 1100010001 11 Apple, juice-babyfood l.420000 0.040 1.000 1100011000 11 Apple, sauce 1. 420000 1

. 000 1.000 1100011001 11 Apple, sauce-baby f oo d 1.420000 1. 000 1.000 1100129000 11 Crabapple 1. 420000 1. 000 1.000 1100173500 11 Goji berry 1. 350000 1. 000 1. 000 1100210000 11 Loquat 1.350000 1. 000 1.000 1100266000 11 Pear 1. 350000 1. 000 1.000 1100266001 11 Pear-babyfood l. 350000 1

. 000 1. 000 1100267000 11 Pear, dried l. 350000 6.250 1.000 1100268000 11 Pear, juice l. 350000 1.000 1.000 1100268001 11 Pear, juice-babyfood 1.350000 1

. 000 1.000 1100310000 11 Quince 1.350000 1.000 1.000 1201090000 12A Cherry 0.622000 1.000 1.000 1201090001 12A Cherry-babyfood 0.622000 1. 000 1.000 1201091000 12A Cherry, j u ice 0.622000 1. 500 1. 000 1201091001 12A Cherry, juice-babyfood 0.622000 1

. 500 1.000 1202012000 12B Apricot 0.038000 1. 000 1

. 000 1202012001 12B Apricot-babyfood 0.038000 1. 000 1.000 1202013000 1 2B Apricot, dried 0.038000 6

. 000 1.000 1202014000 12B Apricot, juice 0.038000 1

. 000 1.000 1202014001 12B Apricot, juice-babyfood 0.038000 1.000 1.000 1202230000 12B Nectarine 0.004000 1.000 1.000 1202260000 12B Peach 0.038000 1.000 0.010 1202260001 12B Peach-babyfood 0.038000 1.000 0.010 1202261000 12B Peach, dried 0.038000 7.000 0.010 1202261001 12B Peach, dried-babyfood 0.038000 7

. 000 0.010 1202262000 12B Peach, juice 0.038000 1

. 000 0.010 1202262001 12B Peach, juice-babyfood 0.038000 1.000 0.010 1203285000 12C Plum 0.002500 1.000 1.000 1203285001 12C Plum-babyfood 0.002500 1

. 000 1.000 1203286000 12C Plum, prune, fres h 0.002500 1. 000 1.000 120328600 1 12C Plum, pru n e , fres h

- babyfood 0

. 002500 1

. 000 1.000 1203287000 12C Plum , prune, dried 0.002500 2.600 1. 000 120328700 1 12C Plum, prune, dried -babyfood 0

. 002500 2.600 1.000 1203288000 12C Plum, prune, juice 0.002500 1. 400 1.000 1203288001 12C Plum, prune, juice- b aby f ood 0.002500 1. 400 1.000 1302057000 13B Blueberry 1.009000 1.000 1.000 1302057001 13B Blueberry-babyfood 1.009000 1.000 1.000 1302136000 13B Currant 1.009000 1.000 1.000 1302137000 13B Currant, dried 1.009000 1.000 1.000 1302149000 13B Elderberry 1.009000 1.000 1.000 1302174000 13B Gooseberry 1.009000 1.000 1.000 1302191000 13B Huckleberry 1.009000 1

. 000 1.000 1304175000 130 Grape 0. 613000 1.000 0.050 1304176000 130 Grape, juice 0.005000 1.000 0.050 1304176001 13 0 Grape, juice- b a b yfood 0.005000 1

. 000 0.050 13 04179000 130 Grape, wine and sherry 0.613000 1.000 0

. 050 1307130000 13G Cranberry 1.009000 1.000 1.000 1307130001 13G Cranberry-babyfood 1. 009000 1

. 000 1.000 1307131000 13G Cranberry, dried 1. 009000 1.000 1.000 1307132000 13G Cranberry, juice 1.009000 1.100 1.000 1307132001 13G Cranberry, juice-babyfood 1.009000 1.100 1.000 1307359000 13G Strawberry 0.495000 1. 000 0.025 1307359001 13G Strawberry-babyfood 0. 4 95000 1.000 0.025 1307360000 13G Strawberry, juice 0.495000 1.000 0.025 1307360001 13G Strawberry, juice-babyfood 0.495000 1.000 0.025 1400003000 14 Almond 0.005000 1.000 0.050 1400003001 14 Almond

- babyfood 0

. 005000 1

. 000 0.050 140000 4 000 14 Almond, oil 0.005000 1

. 000 0.050 1400004001 14 Almond, oil-baby f oo d 0

. 005000 1

. 000 0

. 050 1400059000 14 Brazil nut 0.007000 1

. 000 1.000 1400068000 14 Butternut 0.007000 1

. 000 1. 000 1400081000 14 Cashew 0.007000 1. 000 1. 000 1400092000 14 Chestnut 0.005000 1

. 000 1.000 1400155000 14 Hazelnut 0.007000 1. 000 1.000 1400156000 14 Hazelnut, oil 0.007000 1

. 000 1.000 1400185000 14 Hickory nut 0.007000 1.000 1.000 1400213000 14 Macadamia nut 0.007000 1. 000 1.000 1400269000 14 Pecan 0.007000 1.000 0.025 1400278000 14 Pine nut 0.007000 1. 000 1.000 1400282000 14 Pistachio 0.005000 1. 000 0.025 1400391000 14 Walnut 0.007000 1. 000 0.025 1500025000 15 Barley, pearled barley 0.100000 1. 000 1. 000 1500025001 15 Barley, pearled b arley- b abyfood 0

. 100000 1. 000 1.000 1500026000 15 Barley, flour 0.100000 1. 000 1.000 

### 22of29

### Dife nocon azo l e Di etary E x

pos ure Assess m ent DP# : 4264 91 P

C Co de : 1 2 8847

1500026001 15 Barley, flour-baby food 0.100000 1. 000 1.000 1500027000 15 Barley, bran 0.100000 1.000 1.000 1500127000 15 Corn, sweet 0.010000 1.000 1.000 1500127001 15 Corn, sweet-baby food 0.010 0 00 1

. 000 1. 000 1500231000 15 Oat, bran 0.010000 1.000 1. 000 1500232000 15 Oat, flour 0.010000 1. 000 1.000 1500232001 15 Oat, flour-babyfood 0.010000 1. 000 1. 000 1500233000 15 Oat, groats/rolled oats 0.010000 1.000 1.000 1500233001 15 Oat, groats/rolled oats-babyfood 0.010000 1. 000 1.000 1500328000 15 Rye, grain 0.010000 1. 000 1.000 1500329000 15 Rye, flour 0.010000 1. 000 1.000 1500381000 15 Triticale, flour 0.100000 1.000 1.000 1500381001 15 Triticale, flour-baby food 0.100000 1.000 1. 000 1500401000 15 Wheat, grain 0.100000 1. 000 0.100 1500401001 15 wheat, grain-babyfoo d 0.100000 1. 000 0.100 1500402000 15 Wheat, flour 0.100000 1. 000 0.100 1500402001 15 wheat, flour-baby food 0.100000 1.000 0.100 1500403000 15 Wheat, germ 0.100000 1. 000 0.100 1500404000 15 Wheat, bran 0.100000 1.000 0.100 2001163000 20A Flax seed, oil 0.100000 1.000 1. 000 2001319000 20A Rapeseed, oil 0.100000 1.000 1 .000 2001319001 20A Rapeseed, oil-babyfood 0.100000 1.000 1.000 2001336000 20A Sesame, seed 0.100000 1.000 1.000 2001336001 20A Sesame, seed-babyfood 0.100000 1. 000 1. 000 2001337000 20A Sesame, oil 0.100000 1. 000 l. 000 2001337001 20A Sesame, oil-babyfood 0.100000 1.000 1.000 2003128000 20C Cottonseed, oil 0.050000 1.000 1.000 2003128001 20C Cottonseed, oil

- babyfood 0.050000 l. 000 1.000 3100044000 31 Beef, meat 0.050000 1.000 1.000 3100044001 31 Beef, mear.-babyfood 0.050000 1. 000 1. 000 3100045000 31 Beef, meat, dried 0.050000 1.920 1.000 3100046000 31 Beef, meat byproducts 0.100000 1.000 1. 000 3100046001 31 Beef, meat byproducts-babyfood 0.100000 1.000 1.000 3100047000 31 Beef, fat 0.100000 1.000 1.000 3100047001 31 Beef, fat-babyfood 0

. 100000 1. 000 1.000 3100048000 31 Beef, kidney 0.100000 1. 000 1. 000 3100049000 31 Beef. liver 0.400000 1. 000 1. 000 3100049001 31 B eef, liver-babyfoo d 0.400000 1. 000 1. 000 3200169000 32 Goat, meat 0.050000 1. 000 1.000 3200170000 32 Goat, meat byproducts 0.100000 1.000 1.000 3200171000 32 Goat, fat 0.100000 1.000 1. 000 3200172000 32 Goat, kidney 0.100000 1.000 1. 000 3200173000 32 Goat, liver 0. 400000 1. 000 1. 000 3300189000 33 Horse. meat 0.050000 1. 000 1. 000 3400290000 34 Pork, meat 0.050000 1. 000 1. 000 3400290001 34 Pork, meat-babyfood 0.050000 1.000 l. 000 34 00291000 34 Pork, skin 0.100000 1.000 1. 000 3400292000 34 Pork, meat byproducts 0.100000 1.000 1. 000 3400292001 34 Pork, meat byproducts-babyfood 0.100000 l. 000 1.000 3400293000 34 Pork, fat 0.100000 1.000 1.000 3400293001 34 Pork, fat

- babyfood 0.100000 l. 000 1.000 3400294000 34 Pork, kidney 0.100000 1. 000 1. 000 3400295000 34 Pork, liver 0. 400000 1. 000 1.000 3500339000 35 Sheep, meat 0.050000 1.000 1. 000 3500339001 35 Sheep, meat-babyfood 0.050000 1.000 1.000 3500340000 35 Sheep, meat byproducts 0.100000 l. 000 1. 000 3500341000 35 Sheep, fat 0.100000 1. 000 1.000 3500341001 35 Sheep, fat-babyfood 0.100000 1.000 1.000 3 50034 2000 35 Sheep, kidney 0.100000 1.000 1. 000 3500343000 35 Sheep, liver 0. 400000 1. 000 1. 000 3600222000 36 Milk, fat 0.020000 1. 000 1. 000 3600222001 36 Milk, fat-baby food/infant formu 0.020000 l. 000 l. 000 3600223000 36 Milk, nonfat solids 0.020000 1.000 l. 000 3600223001 36 Milk, nonfat solids-baby food / in 0.020000 1.000 1.000 3600224000 36 Milk, water 0.020000 1. 000 1. 000 3600224001 36 Milk, water-babyfood/infant form 0.020000 l. 000 1. 000 3600225001 36 Milk, suga r (lactose)-baby foo d / 0

. 020000 l. 000 1

. 000 7000145000 70 Egg, whole 0.020000 l. 000 1. 000 7000145001 70 Egg, whole-babyfood 0.020000 1.000 1.000 7 000146000 70 Egg, white 0.020000 l. 000 1. 000 7000146001 70 Egg, white (solids)-babyfood 0.020000 1.000 1. 000 7000147000 70 Egg, yolk 0.020000 1

. 000 1.000 7000147001 70 Egg, yolk

- babyfood 0.020000 l. 000 1

. 000 8601000000 86A water, direct, all sources 0.013600 1.000 1.000 8602000000 86B water, indirect, all sources 0.013600 1.000 1.000 9500016000 0 Artichoke, globe 0.469000 1.000 1.000 9500023000 0 Banana 0.002500 1.000 1.000 9500023001 0 Banana-babyfood 0

. 002500 1.000 1.000 

## 23 of 2 9

### Difenoconazole Di etary Exposure Assessment DP#: 426491 P

C Co de: 1 2 884 7
9500024000 0 Banana, dried 0.002500 3.900 1.000 9500024001 0 Banana, dried-babyfood 0.002500 3

. 900 l.000 9500177000 0 Grape, leaves 0.613000 l.000 0.050 9500178000 0 Grape. raisin 0.613000 3

. 500 0.050 9500215000 0 Mango 0.070000 1. 000 1. 000 9500215001 0 Mango-babyfood 0.070000 1. 000 1.000 9500216000 0 Mango, dried 0.070000 l.00 0 1. 000 9500217000 0 Mango, juice 0 .070000 1. 000 l.000 9500217001 0 Mango, juice-babyfoo d 0.070000 l. 000 l.000 9500245000 0 Papaya 0. 013000 l. 000 1.000 9500245001 0 Papaya

- babyfood 0.013000 1.0 00 1.000 9500246000 0 Papaya, dried 0.013000 l.800 1. 000 9500247000 0 Papaya, juice 0. 013000 1.500 l.000 9500283000 0 Plantain 0

. 002500 1.000 1.000 950028 4 000 0 Plantain, dried 0.002500 3.900 1.000



## 24of29

### Difen oco nazole PC Code: 12 8847 

### Dietary Exposu r e Assessment DP#: 42649 1



### Attachment 4: DEEM-FCID Chronic E xposure Estimates

US EPA DEEM

- FCID Chronic analysis for DIFE N OCONAZOLE Residue file name: C:\users\tmorton\Documents\My Difenoconazole 4E8274 Mar 2015 \1 28847Chronic Mar ver. 3.16 , 03 -08- d NHANES 2003-2008 2-day Files \ DEEM Files \12 8847 D i fenoconazole\128847 2 015 Food and Water.ROS Analysis Date 04-14-20 1S /0 7:14:49 Reference dose (RfD, Chronic) 

## = .01 Adjustm ent factor #2 used. Residue file dated: 04-14-2015/07 :13:52 mg /kg bw/day Total exposure by popu latio n subgroup

Popula tion

Subgroup Total us Population Hispan ic Non-Hisp -White Non

- His p-Black Non

- His p-Other Nur si ng Infan ts Non

- Nursing Infants Female 13+ PREG Children 1

- 6 Children 7

- 12 Ma le 13-19 Femal e 13-19 / NP Mal e 20+ Female 20+/ NP Sen iors SS+ All In fants Female 13 -50 Children 1-2 Children 3-5 Children 6- 1 2 Youth 13-19 Adults 20- 49 Adults S0-99 Fema le 13-49



### FOOD ONLY

US EPA Total Exposure mg/kg body wt/ day

0.002S91 0

. 00 2761 0.00 2499 0.00 2689 0.003154 0.004996 0.008894 0. 002239 0.006947 0

. 003413 0.002073 0.001966 0.002008 0 .001 940 0.00 2096 0

. 007691 0 .0018S9 0 .008894 0.006043 0.003709 0 .002016 0

. 001893 0 .00209S 0 .001856 Percent of Rfd

25.9\ 27.6\ 25.0\ 26

. 9\ 31. 5\ SO

. O\ 88.9\ 22

. 4\ 69.S\ 34 .1\ 20

. 7\ 19.7\ 20

. 1\ 19. 4\ 21. 0\ 76 .9 \ 1 8.6\ 88.9\ 60. 4\ 37

. H 20 .2 \ 1 8.9\ 21. 0\ 18 .6\

DEEM -FCI D Chronic analysis for DI FENOCONAZ OLE Residue file name : C : \ Users \tmor ton \ Documen ts\ M y Difenocona zol e 4E8274 Mar 201S\1288 4 7C hr onic M ar Ver. 3

. 16, 03-08-d NHANES 2003-20 08 2-day Files \DEEM Fi les\128847 Difenoc o nazole \ 12884 7 2015 Food Only.ROB Analysis Date 04-14-201S/07 :1 5:08 Reference dose ( RfD , Chronic ) 

### = .01 Adjustment factor #2 used. Residue file da ted: 04-14-2015/06 :Sl:34 mg/kg bw/d ay
======== == = ==== ===c= ========= ••==== ====== ========= == ===========================

Populat ion

Subgroup Tota l US Population H

ispanic N

on-Hisp-Wh ite Non

- Hisp-Black Non -His p-Other Nursing Infants Non -Nursi ng Infan ts Femal e 13+ PREG Children 1-6 Total exposure by population subgroup

Total Exposure mg/kg body wt/ day 0

. 002 3 06 0.002489 0.002206 0

. 002454 0.00 2826 0 .004739 0.007947 0. 001971 0

. 006S82 

## 25 of29 Percent of Rfd
23.H 24

. 9\ 22 .1\ 24.5\ 28. 3\ 4 7. 4\ 79 .St 19 .7 \ 65 .8 \

### Difenoconaz ole Di e tary E xposure Assessment DPff : 426491 PC Code: 128847

Children 7-12 0.003176 31. 8\' Male 13-19 0

. 001877 1 8

. 8\' Female 13-19/ N P 0

. 001747 1 7

. 5\' Male 20+ 0

. 001743 1 7

. 4\' Female 20+/ N P 0

. 001641 1 6

. 4\' Seniors 55+ 0

. 001821 18.2\' A ll Infants 0.006957 69

. 6\' Fema l e 13-50 0

. 001576 15

. 8\' Children 1 -2 0.008 4 83 8 4. st Children 3-5 0.005697 57

. 0\' Children 6-12 0

. 003459 34

. 6\' Yout h 13-19 0

. 001809 1 8

. 1\ Adults 20-49 0

. 001609 1 6

. 1\ Adults 50-99 0

. 001815 18

. H Female 13

- 49 0

. 001573 15

. 7\



## 26 of29

### Difenoconazole PC Code: 12884 7 Dietary Exposure Assessment



### Attachment 5: Percent C rop Treated Memorandum
Difenoconazole (128847) Screeni ng Level Usage Analysis (SLUA) Date: October 2, 2014
What i s a S cr eening Level Usage Analysis (S L UA)? DP# : 426491



### • Available estimates of pesticide usage data for a particular ac ti ve ingredient that is used o n 

### agricu ltural crops in the United States

. • Pesticide u sage data obtained from various sources . The d ata are then merged , averaged, and rounded so that the presented information is not propri e tary, bu s iness co nfide nti a l, or trade secret. 

### What does it contain? • P esticide usage data for a 

### sing le ac ti ve in g r ed ient only. • Agricultura l use sites (crops) that the pesticide is 

### reported to be u sed o n . • Available pes ti cide u sage information from U.S. states t ha t produce 80% or more of a crop , in mo s t cases, or less than 

## 80 %, in rare cases, depending on the scope of the survey and available resources. • A nnu a l percent of crop treated 

### (average & maximum) fo r eac h ag ri cu ltural crop. • Average a nnu a l po und s of the pestic id e applied fo r each agric ultura l c rop ( i.e. , for the states s urv eyed, not for the e ntire U nited States)

. 

### What ass umption s can 

### I make abo ut the reported data? • Average pound s of active ingredient app lied

- Values are ca lc ul ated by merging pesticide u sage data sources together ; averag ing across all observati ons, then round ing. 

### No te : 

# If the estimated value is less than 500 , th en that value is labeled <500. Estimated values between 500 

## & < l , 000, 000 ar e round ed to I significant digit. Estimated values of I

, 000, 000 o r gre ater are round ed to 2 significant digits.) • Average percent of crop treated

- Values are ca lc u lated by merging data sources togethe r ; averag in g by ye ar, ave r ag in g across a ll years, & 

### rounding to the nearest mu ltip le of 

### 5

. 

### Note: 

# If th e es tim ated va lu e is less than 2.5, th en the value is labeled < 2.5. 

# If th e es timated value is less than I

. 

### then the value is lab e led < l. • Maximum percent of crop treate d

- Va lu e is the si ngle m ax imum value reported across a ll data so urces , across all years , & 

### rounded up to the nearest multipl e of 

### 5. 

### N ote: 

# If the estimated value i s less than 2.5 , then the value is lab eled < 2.5. What a r e th e data so urce s u sed? • USDA-NASS (Un ited S t ates Departm e nt of Agric ulture's Na ti o na l Ag ri cultura l Statistics Serv ice)

- pesticide usage data from 2004 

### to 20 1 2. 

### • Private pe s ticide market re search

- p es ticid e u sage data from 20 04 

### to 2 012. 

### • Ca liforni a Department of Pesticide Regulation (DPR) Pe s ticide Use Reporting (PUR) data for 2004 

### to 20 11

. 

### What a re the limitation s to the data ? • Additiona l reg i s tered u ses may exis t but are not included because the ava il able s u

rveys do not report u sage (e.g., s mall acreage crops). • L ack of reported usage data for the pesticide o n a crop 

### does not imp ly zero usage. • Usage data o n a particu l ar s ite may be noted in data so urce s, but 

### not quantified. In these in sta nces , the s ite would not be repo r ted in the S LUA

. 27o f 29

### Di fenoconazole PC Co de: 128847 

### Dietary Exposure Assessment DP # : 426491



### • Non-agricultural use sites (e.g., turf , post-harvest, mosquito co n trol , etc.) are not reported in the SLUA. A separate request must be made to receive these estimates. • Some si t es show so me us e, even though they are not on the label. Th is usage could be due to var ious factors, includin g, but not limited to Sect ion 18 requests , existing stocks of th e chemical , data collection errors, and experimental use permits (EUPs).

28 of29

### Difenoconazole PC Code: 128847 

### Dietary Exposure Assessme nt DP# : 42649 1



### Date : October 2 , 2014 Sc reening Level Estimates of Agricultural Uses of Difen ocooazole ( 128847) Sorted A lphabetically R Y 2004 2012

epo rtme: ea rs: 

## - Average Percent Crop Treated Crop Lb s. A. I. Average Maximum I 

### Almond s 2 

### Aooles 3 

### Brussels Sprouts 

# • 4 

### Cabbage 5 

### Ca ntaloupes 6 

### Cucum bers 7 

### Garlic 8 

### Grapefruit 9 

### Grapes 10 

### Onions 11 

### Oranges 12 

### P eaches 13 

### Pears 14 

### P ecans 1 5 

### P co oers 16 

### Pistac hi os 17 

### Potatoes 18 

### Pumpkins 19 

### Squash 20 

### Strawb erries 21 

### Sugar Beets 22 

### Tangerin es 23 

### Tomatoes 24 

### Walnuts 25 

### Watermelons 26 

### Wheat (See d Treatm ent)
All numbers are rounded. < 500: 

### le ss th an 500 

### pounds of active ingredients . < 2.5: 

### l ess than 2.5 

### percent of cro p is treated. < I : less th an I percent o f crop is treated. 7,000 5 7 , 000 15
< 500 

### NC
< 500 <2. 5
< 500 <2.5 3,000 5
< 500 5
<500 

### <>**~** _,) 9 , 000 5 2,0 00 5 1,000 <2.5
< 500 < I
< 500 5 1 ,000 <2

. 5 < 500 <2.5
< 500 <2.5 20,000 15
< 500 

### <>**~** _,) < 500 5
< 500 <2.5 20,000 15

1, 000 <2.5 7 , 000 

## r _) < 500 <2 .5 2, 000 5 40,000 10



### * Base d o n CA DPR data only ( 80 % 

### or more of U.S. ac res grown are in Ca li fornia) NC: not calcu lated, on l y pound s a.i. ava ilable. SLUA data sources include: USDA-NASS (United States Department of Agriculture's National Agricultural Statistics Service) Private Pe sticide Market R esearch California DPR ( D epartment of Pesticide R eg ul atio n) These re s ult s re n ec t amalgamated data developed by the A ge ncy and are rel easable to the publi c. 

## 29 of29 15 25 

### NC

5
<2 .5

10 5 <2.5

10 10 <2.5 <2.5

10
<2.5

5 5 30 5 10 <2 .5 30 <2.5 40
< 2.5

10 15