### Metrafenone Dietary Exposure and Risk Assessment DP Number: 411390 

### UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D.C. 20460

MEMORANDUM Date: July 7 , 2014 OFFICE OF CHEMICAL SAFETY AND POLLUTION PREVENTION



### SUBJECT: Mctrafcnonc. Chronic Aggregate Dietary (Food and Drinking Water) Exposure and Risk Assessment for th e Section 3 Registration Action on: Apricot, Cherry (Crop Subgroup 12- 12A); Fruiting Vege tables (Crop Group 8-1 0); Fruit, Small, Vine C limbing , Except Fuzzy Kiwifruit (Crop Subgroup 13-07F); Hops, Dried Cones; Peach (Crop Subgroup 12-12B), Pome Fruit (Crop Group ll-1 0), and Vegetable, Cucurbit (Crop Group 9). P C Code: 000325 DP Number: 411390,417653,417648 Decisio n No.: D476552, D480739 , D4 84338 Reg istrati o n No.: 7969-283, 796 9-284 P etiti on No.: 3 F8 163 , 3F8187, 3£8211 Regul atory Action: Secti o n 3 Registration Ri sk Assess men t Type : Dietary Case No.: None TXR No.: None CAS No.: 220899-03-6 MRID No.: None 40 CFR: §180.624 

### FROM: Dennis McNeilly, Chemist 

# £2.--- fo( v 

# h/) ·**-~** Risk Assessment Branch II 

# cRXB' m ,__.- -**~** Health Effects Division (HED; 7509P) THROUGH: Nancy Dodd,

# hemist~**~** Bill Cutchin, Chemist
.

### A§_" 

# {J J(; {
.... .. Dietary Exposure Science Advisory Council Michae l 

# Do:!, Ph.D., Senior Scientist

# ~

# ii;).£.4: Risk Assessment Branch II (RAB II) Health Effe cts Division (RED; 7509P) TO: Tony Ki s h , RM 22 Fungicide Branch/Re gistration Di v is i on (7505 P) and Laura Nollen!Barbara Madden, RM 05 Ri sk Integration, M in or Use, E mergency Re spo n se Branch Registration Division (7505P)

Page 1 of 13

### Metrafenone Dietary Exposure and Risk Assessment DP Number: 411390 Executive Summary 

### A chronic dietary [food and drinking water] exposure and risk assessment was conducted using the Dietary Exposure Evaluation Model software with the Food Commodity Intake Database (DEEM-FCID) Version 3.16. This software uses 2003-2008 food consumption data from the U.S. Department of Agriculture's National Health and Nutrition Examination Survey, What We Eat in America (NHANES/WWEIA). The analys is was performed to evaluate a Section 3 request for the establishment of tolerances for residues of metrafenone inion apricot, cherry (crop subgroup 12-12A), fruiting vegetable (crop group 8-1 0); hops, dried cone; peach (crop subgroup 12 -12B), pome fruit (crop group 11-1 

### 0); fruit, small vine climbing (crop subgroup 13

- 07F), except fuzzy kiwifruit; and vegetable, cucurbit (crop group 9). This memorandum was reviewed by two peer reviewers of the DESAC, per DESAC SOP 2012.1. 

### Acute Dietary (Food + Drinking Water) No acute dietary toxicity endpo i nt cou l d be identified based on the toxicology data currently available for metrafenone; therefore, no acute dietary exposure assessment for metrafenone was conducted. 

### Chronic Dietary (Food + Drinking Water) Exposure Results and Characterization A chronic dietary exposure assessment was performed for metrafenone. The assumptions underlying this unrefined assessment were 100% crop treated (CT), RED-recommended tolerance levels or tolerance-level residues, and default DEEM -F CIDTM (ver. 7
. 81) processing factors (with th e exception of chemical-specific empirical processing factors (PF) described in Table 3). The mean (i.e., relevant to chronic exposure) drinking water estimate of 14.52 11-g!L was prov ided by the Environmental Fate and Effects Division (EFED) and directly incorporated into the chronic assessment. The estimated drinking water concentration (EDWC) of 14.52 11-g/L reflects surface water concentration. For the general U.S. population, the exposure from food and drinking water u tilizes 3.7% of the chronic population adjusted dose (cPAD). The chronic dietary risk estimate for the most highly exposed popu l ation subgroup, children 1-2 years o ld , is 16% ofthe cPAD. The chronic dietary risk assessment shows that for all included commodities, the chronic dietary risk estimates are be l ow the Agency's level of concern (i
. e. <1 00% cPAD). 

### Cancer Dietary An assessment of cancer risk was not performed. 

### In accordance with 

### EPA 's Final Guidelines for Carcinogen RiskAssessment (March, 2005), the Cancer Assessment Review Committee (CARC) classified metrafenone as having "Suggestive Evidence of Carcinogenicity," but concluded that quantification of carcinogenic potential is not required.

Page 2 of 13

### Metrafenone Dietary Exposure and Risk Assess m en t DP Number: 41 1390 

### I. Introduction Dietary risk assess ment incorporates both exposure and tox ic ity of a given pesticide. For acute and chronic assessme nts, the risk is expressed as a percentage of a maximum acceptable do se (i.e. , the maximum dose at w hich HED has concluded that there is a reasonab l e expectation of no adver se health effects). This do se i s referred to as th e population-adjusted dose (P AD). The PAD i s equivalent t o the point of departure (e.g., NOAEL , LOAEL) divided by the required uncertainty or safety facto rs . References that discu ss chronic risk asses sment in m o re d eta il are availab le on the E PA/pe st icides website: "Av ailable Information on Assessing Ex po s ure from Pesticides, A User's Gu id e," 6/21/2 000 , web link: http: //www.epa.gov/fedrgstr/EPA-PEST/2000/July/D ay12/606 l.pdf ; or see SOP 99.6 (8/20/ 1999). The most rece nt dietary risk assessment for metrafenon e was conducted (D371367, D. McNeilly, 2

/ 18/2 01 0) fo r a Sect ion 3 request for u se on grapes. 

### II. Residue Information Current Tolerances: 

### The chronic dietary risk assessment was based on the assumption o f tole rance-level residues. Met raf e none is a benzophenone fungicide that rep ortedly has preve nt ive properties f or control of powdery mild ew produced by Uncinula neca tor 

### in co mmercial variet ies of grape, Podosphaera 

### in pome fruit, and powdery mildew in other crops. There are tolerances for the use of metrafenone on grapes in the U.S. The to leranc e s are established under 40 CFR § 180.624(a) for residues ofmetrafenone in/on grape at 4
. 5 ppm and raisins at 1 7 .0 ppm. R ecomme nd ed Tolerances: 

### The pet itioner has proposed new Section 3 uses for : ap ricot, cherry (crop sub g roup 12-1 2A), fruiting vegetable s (crop group 8-1 0); fruit, small vine climbing, except fuzzy kiwifruit (crop subgroup 13-07F) ; hop s, dried co n es; p eac h (crop subgroup 12

- 12B), pome fruit (crop gro up 11-1 0) ; and vegetable , cucurbit , (crop group 9). The chronic dietary risk assessment was ba sed on the assumption ofHEO-recommended tole rance l eve l residues as li sted in Tabl e 1 for the proposed new uses (0407432, D411389, 0414077 , 0416465, 0417602, W. Drew ; Ju ly 7 , 20 14 ). 

### Table 1. RED-Recommended Tolerances Commodity HED -Reconunended Tolerance (ppm) Ap ri cot 0.70 Ch erry subgr oup 12-12A 2. 0 Fruit, pome , g r oup 1 1-10 1.5 Fruit , small , vi ne c limbi ng, except fuzzy 

### 4.5 kiwifruit , subg roup 13-07F Hops , co n es, dried 

### 70 Peac h subgr oup 12-12B 0.70
Page 3 of 13Metrafenone Dietary Exposure and Risk As sess ment DP Number: 411390 

### Table 1. 

### BED-Recommended Tolerances Commodity RED-Recommended Tolerance (ppm) Vegetable, c ucurbit, group 9 0.50 Vegetable s, fruiting , gro up 8-10 0.90
Residue Data used for the Chronic Dietary Assessment: 

### R esidues of Concer n (residues included in die tary exposure analysis): For the primary crops, metrafenone parent serves as an adequate m e asure of product misu se based on its percentage of the total radioactive residues (TRR) in the metabolism study an d the significant residues seen in crop field trial s . For dietary risk assessment purposes , HED concludes that some of the significant amounts of tentatively identified and unidentified material in the grape metabolism study need s to be included (the two other metabolism s tudies with cucumber and wheat were s imilar). The tentatively identified metaboli tes in the "acetone unknowns " and "juice" fractions re tain the dual rin g s tructure of the parent compound. Such r es idues may be of comparable toxicity to parent metrafenone. At this time , the residues described as "aceto ne unknowns " and "j uice " s h o uld be included along with the parent fo r assessing dietary risk. T his approach would account for 93% and 77% of the TRR in the grapes harvested after the fifth application of the bromoph enyl (B P) labeled metrafenone ([bromopheny l- 6

- 14 C] m et r afenone) and trimethoxyphenyl (TMP ) labeled metrafenone ([trim ethoxyph e ny l- U

- 14C] metrafenone) , respectively. D ata from the metrafenone grape, cucumber, and wheat metabolism studies wer e used to derive a dietary exposure adjustment factor by div iding residue s (as a percent of the TRR) of the parent plu s the "acetone unknowns" and "juice" fraction s by the res idu e of parent only. Conducting this evaluation for both radio labels and both harvesting intervals res ulted in a maximum ratio of 2.1 and an average ratio of 1.9
. HED decided to use a dietary exposure ratio factor of2.0. This adjustment factor was then used to convert tolerance levels for the parent to residues of parent plus th e " acetone unknowns" and "juice" fractions (see ROCKS Memo , D370903, G. Kramer , 1 1119/2009). TABLE2. Metrafenone Metabolism Adjus t ment Factor. BP Label TMPLabel Maximum/ Average Ratio 2 Grape Residue (%TRR) 1 Post Post Application 5 35 OAT Application 5 35 OAT

0-0ay PHI 0-Day PHI Metrafenone 53.3% 24.7% 40.7% 22.8% "Acetone 32.6%


### -- 23.5% 

## -- Unknown " "TRR in Juice 7.1% 1 8% 1 2.5% 25.3% fraction " Ratio 2 1.74 1.73 1.88 2 .11 2.1 / 1.9 Cucumber (Whole fruit) Page 4 

### of 13

### Metrafenone Dietary Exposure and Risk Assessment DP Number: 411390 TABLE2. Metr:af enone Metabolism Adjustment Factor. BP Label TMP Label Maximum/ Average Ratio2 Residue (%TRR) 1 No BP Labe l No BPLabel 14-DATI 3 - DAT2 Metrafenone 

### - 

## -- 12.6% 42.4% "Unknowns in polar 

## -- -- 24.0% region" 13 .1 % "Unknowns in 

## -- 

## -- med ium polar 41.3% 23.4% region " Ratio 2


## -- -- 6.03 2
.0 2.0 Wheat Gra i n) Residue (%TRR) 1 ppm (%TRR) 1 ppm Metrafenone 7.7% 0.016 3.1% 0.013 Unknown ROI 15 .1% 0 .032 20.2% 0
.081 Unknowns ROI 2- < 2% <0
. 004 <2% <0
.004 11 Ratio 2 3.22 8.16 8.16/ 5.69 Wheat**(Forag~ _**  Residue (%TRR) 1 ppm (%TRR) 1 ppm Metrafenone 64.4% 5.261 58.9% 3.101 All metabolites and 27 .3% 2 .228 27.6% 1.444 unknowns in extract Ratio 2 1.42 1.47 1.47/ 1.45 Wheat(Hay) Residue (%TRR) 1 ppm (%TRR) 1 ppm Metrafenone 26.0% 2.021 12
.7% 1.078 All metabolites and 50.0% 3.905 59.8% 5.095 unknowns in extract Ratio 2 2.92 5.71 5.7l/4.32 Wheat Straw) Residue (%TRR) 1 ppm (%TRR) 1 ppm Metrafenone 13.6% 1.215 7.7% 0.635 All metabolites and 39.1% 3
. 511 44.9% 3.702 unknowns in extract Ratio 2 3 .88 6.83 6.83 / 5.36 I
. TRR= Total Radioactive Residues 2. Ratio = (parent + other ROC) /parent. 

### To obtain dietary exposure residue values for the existing and proposed commodities, a factor of 2.0 was entered into the adjustment factor 2 column of the DEEM analysis. The higher factors for wheat grain or wheat hay/straw were not used be cause there are no existing or pending uses on grains. The factors for grape and cucumber are a better match for the type of crops that are currently being proposed for registration (fruits/vegetables). Since the drinking water assessment is based on a TTR approach, the dietary exposure adjustment factor of2 is not used in column 2 of the DEEM input files for the drinking water estimate. Processing Factors: 

### The chemical-specific empirical processing factors in Table 3 have been Page 5 of 13

### Metrafenone D i etary Exposure and Risk Assessment DP Number: 411390 

### used in this assessment, otherwise DEEM

- FC I DTM (ver. 7.8 1 ) default p rocessi n g factors are assumed
. Table 3
. Metrafenon e Processine: Factors. Commodity Processing Factors (ppm) Apple Dried 0.6 Juice 0.2 Sauce 4.5 Grape Raisin N / A, Raisin tolerance value was used Wine / Sheny 0.7 Tomato Juice 0.33 Paste 0.4 Puree 0.95


### Livestock: 

### The only livestock feed item assoc i ated w ith the proposed metrafenone new uses is a

p ple wet pomace, and it is fed only to dairy cattle, at a maximum of 1 0% of the d i et. Twelve apple field trials were cond ucted, with a HA FT value of 0.760 ppm for the parent com p ound. An average processing factor of 1 .2 was determined for apple wet pomace in the apple processing study. Therefore, the adjusted metrafenone residues in apple p omace are 0. 760 ppm x 1.2 PF 

## = 0.912 ppm. When goats in the metabolism study were dosed at 87 ppm in the feed, t he highest metrafenone residue in tissues was i n liver at 0.269 ppm. Scaling down to the anticipated dietary burd en to dairy cattle of 0.228 mg/kg i n feed, anticipated metrafenone res i dues are no t expected to exceed 0.0007 ppm in liver, well below the limi t of detection (LOD). Residues woul d occur at lower levels in muscle, fat and milk. There is no reasonab le expectation of residues above th e limit of quantitation (LOQ) of 0.01 p pm in the milk or tissues of ruminant an i mals
. Therefore, tolerances in livestock commod it i es are not required
. Fish: 

### The USDA Pesticide Data Program (PDP) monitored pesticide residues i n catfish in 2008, 2009, and 2010; however, the samples were not analyzed for metrafenone. As a result, residues in fish were not included i n the assessment. 

### III. Percent Crop Treated Information The chronic assessments are based on 1 00% crop treated assumptions for all commodities. 

### IV. Drinking Water Data Drinking Water Assessment for the Proposed Uses ofMetrafenone [(3-bromo-6-methyoxy-2

- methylphenyl) (2,3 ,4- trimethoxy-6-methylphenyl) methanone] on Pome Fru its, Fruiting Vegetables, Peach Subgroup 12

- 12B, Apricot , Cheny Subgroup 12-12A, Cucurbit Vegetables (Group 9), and Fruit, Small Vine Climbing (except Fuzzy Kiwifruit) Subgroup 13-07F, 0411540, James A. Hetrick, 11 / 25/2013.



### Page 6 of 13Metrafenone Dietary Exposure and R i sk Assessment DP Numbe r: 411390 The PRZM E XAMS Tier 

### II screening level concentrations in surface water for total metrafenone residues in drinking water for use in the human health dietary risk assessment are 25.64 f.!g/L for 1

- in

- 10-year peak, 14
. 52 f.!g/L for the 1-in-10-year annual average, and 9.22 11g/L for the 30

-year annual average. Using PRZM-GW , total metrafenone residues in groundwater are not expected to exceed 12.5 11g/L for the peak EDWC and 12.3 11g/L for the post
- breakthrough concentration (current use on grape). An analysis of the re s idue s of concern for metrafenone i ndicate that the only identified major degradation product is CL 377160 [methanone, (3-bromo-6-methoxy-2

- methylphenyl)(3- hydroxy

-2,4

- dimethoxy-6-methylphenyl)

- ]. Thi s degradation product was detected in soil photolysis and anaerobic aquatic metabolism studies. Most degradation processes a l so resulted in formation of a s ub s tantial amount of minor degradates, some individually measured and identified, but most were not. Although a ll of these degradates were present at less than 1 0%, and some at very l ow levels, these residues may be of exposure concern. In some cases minor degradates, mostly unidentified , make up more than 50% of the app lie d radioactivity in a single sampl in g event. In addition, based on the structure of the parent compound and the proposed degradation pa thways, many of the minor degrada tes may have a high degree of structura l similarity to each other and/or the parent resulting in a simi l ar toxic ity profile and cumulative effects. Becau se of the s tructural similarity of many degradation products with the parent compound as well as a high numb er of unid entified minor degradation products, the drinking water assessment (DWA) for metrafenone was conduc ted using a total toxic residues approach (TTR). The TTR consists of parent metrafenone, CL4084564, CL375228, CL377160, CL 377096, CL434223, CL377095,CL 1023424, CL 3000402,TN, MB , DG, GF, and unidentified ex t ractable residues (ROCKS Memorandum, 8/29/2009). The peak EDWC for total metrafenone re sidues based on the proposed uses [Pome Fruits, Frui t ing Vegetables, Peach Subgroup 12- 1 2B, Apricot, Cherry Subgroup 1 2

- 12A, Cucurbit Vegetables (Group 

### 9), and Fruit, Small, Vine Climbing (except F u zzy Kiwifruit) Subgroup 

### 13

- 07F] is higher than the peak EDWC for the current use on grapes (Table 4). However, the 1-in10-yea r annual average and 30

- year annual average EDWCs for the proposed new uses are lower than the EDWCs for the grape use .
Table 4: Tier II PRZM/EXAMS and Tier I PRZM-GW EDWCs for Total Metraf enone Residues in Drinking Water
Models 1 -in- 10 year 30-year Uses Annual Annual Peak, Average, !!giL Average, J,lg!L ll21L Pome Fruits, Fruiting Vegetables, Peach Subgroup 12-I2B, PRZM/EXAMS Apricot, Cherry Subgroup 12- 12A, Cucurbit Vegetab les 25
. 64 7
. 25 5.71 (Group 9), and Fru it , Small, Vine Climbing (except Fuzzy Kiwifruit) Subgroup 13

- 07F PRZM/ EXAMS Grapes 23
. 71 14.52 9.22

PRZM-GW All Uses 12 .5 12.3 The PRZM/EXAMS surface water value was higher than the g round water value. As a result, the Page 7 of 13

### Metrafenone Dietary Exposure and Risk Assessment DP Number: 411390 surface water estimate of 14.52 11g/L (ppb) w as incorporated directly into these dietary assessments und er the DEEM-FCID food categories "water, all sources" and "water, indirect, all 

### sources . " The model and its description are available at the EPA internet site: http:/ /www
. epa.gov/oppe f e d 1 

### /mo del s/wa ter/. 

### V. DEEM-FCIDTM Program and Consumption Information The metrafenone chronic dietary exposure assessment was conducted using the Dietary Exposure Evaluation Model software with the Food Commodity Intake Database DEEM-FCID, Version 3.16, which incorporates 2003

- 2008 consumption data from USDA's NHANES/ WWEIA. The data are based on the reported consumption of more than 20,000 individuals over two nonconsecutive survey days. Foods ''as consumed" (e.g., apple p i e) are linked to EPA-defined food commodities (e.g., apples, peeled fruit

- cooked; fresh or N/S; baked; or wheat flour

- cooked; fresh or N/S, baked) using publicly available recipe translation files developed jointly by USDA/ ARS and EPA. For chronic exposure assessment, consumption data are averaged for the entire U
. S. population and within population subgroups. Based on analysis of the 2003 -20 08 WWEIA consumption data, which took into account dietary patterns and survey respondents , HED concluded that it is most appropriate to report risk for the following population subgroups: the general U.S. popu l ation, all infant s 

### (<1 year old), children 1

-2, children 3-5, children 6

- 12, youth 13-19, adults 20

- 49, females 13 -4 9, and adults 50-99 years old
. For a chronic dietary exposure assessment, an estimate of th e residue level in each food or food

form (e.g. , orange or orange juice) on the food commodity residue list is multip li ed by the average daily consumption estimate for that food/food form to produce a residue intake estimate. The resulting residue intake estimate for each food/food form is summed with the residue intake estimates for all other food/food forms on the commodity residue list to arrive at the to tal average estimated exposure. Exposure is expressed i n mg/kg body weight/day and as a percent of the cPAD
. This procedure is performed for each population subgroup. 

### VI. Toxicological Information HED eval uated the toxicology data base of metrafenone and selected a dose and endpoint for chronic dietary risk assessment based on evidence of liver toxicity. No acute dietary exposure assessment for me trafenone has been conducted because no appropriate endpoint attributable to a single dose was identified. In accordance with EPA 's Final Guidelines for Carcinogen Risk Assessment 

### (March, 2005), the Cancer Assessment Review Committee (CARC) classified metrafenone as having "Suggestive Evidence of Carcinogenicity," but concluded that quantification of carcinogenic potential is not required. As a result, a cancer dietary exposure analysis was not performed. Doses and toxicological endpoints selected for the chronic dietary exposure scenario are summarized in Table 5.

Page 8 of 13

### M e trafen o n e Di e tary Ex p os ure and Ri sk Ass e ssm ent DP Number: 4 1 1390

Table S. Summ a ry of T ox ico l ogical Doses and Endpoints f or U se in Dietary H u man Health Risk Assessme n ts for Metrafeoone Expo sure Do se Use d in Ri sk FQPA S F and L e v e l of Stu dy and T oxicological E ffects Scen ario A ssessment, UF Concern fo r Ri s k POD Assessment Acute Di e tary (All N one None No a pp r opriate dos e and e ndpoint could be pop ulation s, inc lu ding id e nt ified for a ny p opul a tion group . infan ts an d chil dr e n) C hron ic D i etary NOAE L= 2 4
. 9 F Q PA S F = l C ombined Chro n ic/C arci n ogenicity

- r at (All popul a ti o ns) mg!kgld ay LOAE L (mglkgld ay) = 2 60 , based on UFA= l Ox c P AD = c hr oni c RID h e patotoxici ty and nep hro tox icity in both U F !F l Ox FQ PA S F sexes C hro nic R ID = 0 .249 mglk g/d ay = 0 .24 9 m glkgl d a

y Cancer ( oral, d e rma l, " Suggest iv e ev idence of carc i no gen ici ty " based on in c rease s in ad enomas and ade nomas pl us inhala ti

on ) c arc in o m as in ma le mic e only at I I 09 mgl k g/day . T h e do se a t w hic h no in crease in t u mors was n oted is 1 56 m g/

k

g/d a y . Quantifi ca ti on of cance r ri sk is not required
. Po mt of Departur e ( POD ) = A data potnt o r an est 1 mated po tnt th at IS dcn ved from ob served dose. r es pon se data and u se d t

o mark t h e be g mmn g o f e xt

r apolat ion t o dete rmin e ri s k assoc iated with lo we r environm enta lly r e levant h uman ex pos ures. NOAEL = no o b served ad verse effect level. LOAEL = lo wes t observed ad verse effect level. UF = uncerta inty f ac t

o r . UFA = extrapola tion fro m animal t o hu m an (i nt e rspeci es). UF 11 = poten tial va riation in se n s iti vity among members o f the h um an popul ation ( intraS peci es)
. FQPA SF= FQPA Safety Fact o r . P A D = populat ion adjusted dose (a= ac ute, c = chroni c). RID • r e fer e nce dose
. 

### VII. Resu l t s/D i scus s ion As stated above , for chronic assess m ent s, HED i s con cerned w he n di et ary risk excee d s 1 00% of t h e PAD. T he DEEM-F CI D TM an alys i s est imates the die tary exposur e of the g e neral U.S. p op u lation an d v ari o u s po pu lati o n sub groups. Tabl e 6 li sts t h e r es ul t s o f the chroni c dietary e x po sure a na lyse s for th e ge neral U .S. p opul at ion , all inf ants ( < 1 year old ), chil d re n 1

-2 , childr en 3

- 5, chil d re n 6-12 , youth 13-19 , f e m ales 1 3- 4 9, adu lt s 20-4 9, and adul ts 50 -99 ye ar s old. Re s ul ts of Chroni c Di etary Ex posure Analys i s In the c hronic d i etary exp osure analys i s , the m os t highly expo s e d populat ion s ub gr o up is C h i ldre n 1- 2 ye ars o ld wh ose expo sure es t i mate utilize s 16 % of the c P AD (T ab le 6 ). The gener al U. S. popu l at i on ex p os ure estimat e u ti li zes 3. 7 % of th e c P A D
. T able 6. S u mmary of D i etary Expos u re and Risk E sti m ates for Metrafe n one (Food and**Drinkin~** Water) Ac ut e D ietary Chronic Di etary C ancer Dietary Dietary D ietary E xpo s ure Expo s ure Exp os ure Popul ation S ub grou p (mglkg/ day) o/oaPAD (mglkg/da y) o/oc PAD (mglkg/da y) General U. S
. Population 0
. 009252 3
. 7 All Infa nts{< I ye ar old ) 0
. 03570 2 14 C h i ld re n 1

- 2 y ears o ld 0
. 0 4 0 770 16 C h ild ren 3 -5 years old 0.024 735 9.9 Ch i ldren 6-12 year s old N /A N / A 0
. 0 121 36 4.9 N / A Youth 1 3- 1 9 years o ld 0.0051 66 2 .1 Ad ults 20·49 ye ars o l d 0
. 006866 2. 8 A d ults 50

- 99 years old 0
. 006686 2 .7 Fe m ales 1 3 -49 ye ars o l d 0
. 0057 3 5 2 .3 N/

A

- No t a ppli ca bl e. 

### Page 9 of 13 Ri sk

N / A

### Metrafenone Dietary Exposure and Risk Assessment DP Number: 411390 VIII. Characterization of Inputs/Outputs 

### This analysis is a highly conservative dietary exposure assessment. A tolerance-level chronic dietary exposure analysis was performed for chronic exposure to metrafenone using DEEMFCIDTM. As the exposure estimates to all popula t ion subgroups were so low, it was not necessary to make refinements to th e chronic dietary analysis. If it had b een necessary to refine the analysis, average field trial values and/or monitoring data could have been used in place of tolerance-level residues. In 

### addition, estima t es of percent crop treated could have been used. Since risk estimates are below HED's lev el of concern, a more highly refined analysis is not needed at this time
. IX. Conclusions 

### Based on the conservative assumptions noted above, chronic dietary risk estimates for metrafenone do not exceed HED's level of concern for the general U.S. population, or any of the population subgroups, including those comprised of infants and children. X. 

### List of Attachments: 

### Attachment 1: Residue Inpu t File for Chronic Analysis Attachment 2: Results of Chronic Dietary Exposure Analysis

Page 10 of 13

### Metrafenone D i etary Exposure and Ri sk Assessment DP Number: 4113 90 A ttachment 1 : Residue Input File f or C hron ic (Non-Cancer) Analys i s US EPA Ver. 3
. 16, 03

- 08

- d DEEM

- FC I D Chronic analysis for METRAFENONE Residue file: J : \Metrafenone\Dietary\METRAFENONE
. R08 Adju st. #2 used 07-02

- 20 1 4/10:28:53 Analys i s Date 07

- 02-20 1 4 Res i due f i le dated : Reference dose (RfD) = 0
. 249 m g/kg bw/da y Crop Food EPA Code Grp Food Name 1100007000 11 1100008000 11 110 00 08001 1 1 110 00 09000 11 1100009001 11 1100010000 1 1 1100010001 11 1100011000 11 110001100 1 1 1 1202012000 12B 1 2020 1 200 1 12B 1 2020 1 3000 128 1 2020 1 4000 128 1 2020 1 400 1 128 0902021000 9B 0901075000 9A 0902088000 98 120 1 090000 12A 120 1 090001 12A 120 1 091000 1 2A 120 1 09 1 001 1 2A 09 02 102000 98 1100129 0 00 11 0 902 135000 9B 08 02 1 48000 8BC 1 302 1 74000 13B 1 304 1 75000 130 1304 1 76000 130 1 30 41 76001 130 9500 1 77000 0 9500178000 0 1304179000 130 0901187000 9A 9500188000 0 11 002 1 0000 11 1 202230000 128 0802234000 8BC 12 02260000 12B 1202260001 12B 12 0 226 1000 1 28 1202261001 1 28 1202 26 2000 1 2 B 1 20226200 1 128 11 00266000 11 11 0026600 1 11 1 100267000 11 1 100268000 11 11 00268001 1 1 0802270000 8B 0802270001 88 0802271000 8B 080227100 1 88 0802272000 8BC 080227200 1 8BC 0802273000 8BC Apple, fruit with peel Apple, peeled fruit Appl e , peeled fru i t
- babyfood Apple, dried Appl e , dried-babyfood Apple, juice Apple, juice

- babyfood App l e , sauce App l e, sauce - babyfood Ap ri cot Apricot

- babyfood Apricot, dried Apricot, j uice Apricot, j uice-baby f ood 8a1sam pear Cantaloupe Chayote, fruit Cherry Cherry-baby f ood Ch erry, ju i ce Ch e rry, ju ice

- babyfood Ch i nese waxgourd Crabapple Cucumber Eggplant Gooseberry G

r ape Grape, juice Grape , juice

- babyfood Grape, l eaves Grape, raisin Grape , wi ne and sherry Hone ydew melon Hop Loquat Nectarine Okra Peach Peach

- babyfood Peach, d ri ed Peach, d rie d

- babyfood Peach, j u i ce Peach, j uice

- babyfood Pear Pear

- babyfood Pear , dried Pear , juice Pear, juice-babyfood Pepp e r , bell Pep p er, be l l-babyfood Peppe r, be l l, dried Pe pper, be l l, dried-babyfood Pepper, nonbe l l Pepper, n onbe l l-baby food Pep per, n onbell, dried 

### Page 1 1 of 13 Residue (p pm)

1.500 000 1 .500000 1. 500000 1. 500000 1. 500000 1. 500000 1
. 500000 1.500000 1 .50 0000 0.700000 0. 7 00000 0.700000 0.700000 0 .7 00000 0. 5 00000 0 .5 00000 0
. 500000 2
. 000000 2
. 0 00000 2
. 0 00 0 00 2
. 0000 00 0.500000 1
. 5 00000 0. 5 00000 0 .9 00000 4
. 500000 4
. 500000 4
. 500000 4
. 500000 4. 500000 1 7
. 000000

4.500000 0
. 500000 70.000000

1
. 500000 0. 7 00000 0.90 0 000 0.700000 0.700000 0.700000 0.700000 0
. 7 0 0000 0. 7000 0 0 1.500000 1
. 500000 1.500000 1
. 500000 1 .500000 0
. 900000 0.900000 0 .9 00000 0
. 900000 0
. 90000 0 0
. 900000 0 .9 00000 Adj
. Facto r s #1 # 2 1. 000 1. 000 1.000 0.600 0.600 0.200 0.200 4.500 4.500 1
. 000 1. 000 6.000 1. 000 1.000 1 .000 1 .00 0 1. 000 1. 000 1. 000 1
. 500 1
. 500 1
. 000 1. 000 1. 000 1
. 000 1. 000 1. 000 0
. 070 0
. 070 1
. 000 1. 000 0.070 1
. 000 1 .000 1
. 000 1 .0 00 1
. 000 1 .000 1 .000 7.000 7.000 1. 000 1.000 1. 000 1. 000 6.250 6.250 1.000 1. 000 1. 000 1. 000 1
. 000 1
. 000 1. 000 1.000 2
. 0 00 2
. 0 00 2
. 000 2
. 000 2 .0 0 0 2.000 2.000 2.000 2
. 000 2.000 2.000 2
. 0 00 2
. 000 2
. 000 2.000 2.000 2.000 2.000 2.000 2. 000 2
. 000 2. 0 00 2
. 0 0 0 2.000 2.000 2 .000 2.000 2. 000 2. 000 2.000 2.000 2.000 2.0 0 0 2.000 2
. 000 2 .00 0 2.000 2.000 2.000 2.000 2.000 2
. 000 2
. 000 2.000 2.000 2.000 2.000 2.000 2
. 000 2.000 2. 000 2. 0 0 0 2.00 0 2.000 2.000

### Metrafen one D ie tary Expo sure and Risk Assessmen t DP 

### Number: 411390 0 902 3 0S O OO 9B Pumpki n 0 .5 00000 l. 0 00 2.000 090230 900 0 9B Pu m pk in , seed 0
. 500000 1 .00 0 2
. 00 0 11003 10 000 11 Qu in ce 1
. 500000 l. 000 2
. 00 0 0 90 23 5600 0 9 B Squash, sum m

er 0
. 5 0 00 00 1 .00 0 2 .00 0 0 902356 0 0 1 9B Squash, summer - bab yf ood 0
. 5 00 00 0 l. 000 2.000 0 90 23 57 0 00 9B Squash, win t er 0
. 5 0 000 0 1
. 000 2 .00 0 0 902357 0 0 1 9 B Squash, wi n t er - b abyf ood 0
. 5 00 000 l. 000 2.000 OS0 1 37 40 00 SA T om ati1 lo 0
. 900000 1. 0 0 0 2.00 0 OS 0 13 75 000 SA T oma to 0
. 900000 1
. 0 0 0 2 .000 OS013 75 0 0 1 SA T oma to
- babyfood 0
. 900 0 00 1
. 0 00 2 .000 OS0 137 600 0 SA T o m a to , pas te 0.900000 0
. 4 0 0 2. 00 0 OS0 137 600 1 SA T o m a to , pas t e - bab yfood 0.900000 0
. 40 0 2
. 00 0 OS0 1 377000 SA T o m ato, p ur ee 0.900000 0.950 2. 00 0 OS0 1 37700 1 SA Tom a t o, p ur ee - babyfood 0. 90 00 00 0 .95 0 2
. 00 0 OS0137SOOO SA Tomat o, drie d 0
. 900000 14. 300 2.0 00 OS0 1 3 7S 001 SA Tomato , drie d

- baby f ood 0
. 900000 1 4. 300 2.000 OS0 1 3 79 00 0 SA Tom a to , juice 0
. 900000 0
. 330 2. 00 0 OS 0 13S OOO O SA Tom a to , T ree 0
. 90 0 00 0 1. 00 0 2. 0 00 S6 01 0 00 0 00 S6 A W ater, direct, al l source s 0
. 0 1 452 0 1. 00 0 1. 0 00 S6 0 20 00 0 00 S6B W ater, i nd i r ect, a ll s ourc es 0
. 0 1 452 0 1. 0 00 1. 000 0 90 13990 00 9A w a t er m

elo n 0
. 500000 1. 0 00 2.000 0 90 14 0 00 00 9A W ate rmelo n , j u i c e 0
. 500000 1. 000 2.000 110 0 173500 11 Goj i b err y 0
. 900 00 0 1. 0 00 2.000



### Page 12of 1 3

### Metrafenone Dietary Exposure and Risk Assessment Attachment 2: Results of Chronic Dietary Exposure Analysis US EP A DEEM-FCID Chronic analysis for METRAFENONE Residue file name: J:\Metrafenone\Dietary\METRAFENONE.R08 

### DP Number: 411390

v e r. 3
. 16, 03

- 0 8- d NHANES 2003

- 2008 2-day Adjustment factor #2 used
. Analysis Date 07-02

- 2014/10:29 :45 Residue file dated: 07

- 02

- 2014/10 :28:53 Reference dose (RfD, Chronic) = .24 9 mg/kg bw/day

Populatio n

Subgroup Total 

### us Population Hispanic Non

- Hisp

- W hite 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 Fe m ale 13-49 Total exposure by p opulation subgroup
Total Exposure mg/kg body wt/ da y 0.009252 0.00954 1 0 .0 09446 0.007765 0.009423 0.026030 0.040022 0. 006110 0.029855 0 .0 10529 0 .004956 0.005397 0.007601 0.006066 0.006636 0.035702 0.005711 0
. 040770 0
. 024735 0
. 012136 0
. 005166 0
. 006866 0
. 006686 0.005735



### Page 

### 13 of 13 Percent of Rfd3 .7 % 3.8% 3.8% 3.1% 3 .8% 10
. 5% 16 .1%

2.5% 12 .0%

4.2% 2.0% 2.2% 3.1% 2.4% 2.7% 14 .3%

2.3% 16.4%

9.9% 4.9% 2.1% 2.8% 2. 7 % 2.3%