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 the Section 3 Registration Action on: Apricot, Cherry (Crop Subgroup 12-

12A); Fruiting Vegetables (Crop Group 8-1 0); Fruit, Small, Vine Climbing, 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). 

PC Code: 000325 DP Number: 411390,417653,417648 

Decision No.: D476552, D480739, D484338 Registration No.: 7969-283, 7969-284 

Petition No.: 3F8 163, 3F8187, 3£8211 Regulatory Action: Section 3 Registration 

Risk Assessment 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 

Bill Cutchin, 

Dodd, 

Chemist 

hemist~ . A§_" {J~ 

J(; { ...... Dietary Exposure Science Advisory Council 

Michael Do:!, Ph.D., Senior Scientist ~ ii;).£.4: Risk Assessment Branch II (RAB II) 

Health Effects Division (RED; 7509P) 

TO: Tony Kish, RM 22 

Fungicide Branch/Registration Division (7505P) 

and 

Laura Nollen!Barbara Madden, RM 05 

Risk Integration, Minor Use, Emergency Response 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 analysis 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 endpoint could 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-FCIDTM (ver. 7.81) processing 

factors (with the 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 provided 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 utilizes 3.7% of the 

chronic population adjusted dose ( cP AD). The chronic dietary risk estimate for the most highly 

exposed population subgroup, children 1-2 years old, is 16% ofthe cPAD. The chronic dietary 

risk assessment shows that for all included commodities, the chronic dietary risk estimates are 

below the Agency's level of concern (i.e. <1 00% cP AD). 

Cancer Dietary 

An assessment of cancer risk was not performed. 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. 

Page 2 of 13 
Metrafenone Dietary Exposure and Risk Assessment DP Number: 41 1390 

I. Introduction 

Dietary risk assessment incorporates both exposure and toxicity of a given pesticide. For acute 

and chronic assessments, the risk is expressed as a percentage of a maximum acceptable dose 

(i.e., the maximum dose at which HED has concluded that there is a reasonable expectation of no 

adverse health effects). This dose is referred to as the population-adjusted dose (PAD). The 

PAD is equivalent to the point of departure (e.g., NOAEL, LOAEL) divided by the required 

uncertainty or safety factors. 

References that discuss chronic risk assessment in more detail are available on the 

EPA/pesticides website: "Available Information on Assessing Exposure from Pesticides, A 

User's Guide," 6/21/2000, web link: http://www.epa.gov/fedrgstr/EPA-PEST/2000/July/Day12/606 l.pdf; or see SOP 99.6 (8/20/1999). 

The most recent dietary risk assessment for metrafenone was conducted (D371367, D. McNeilly, 

2/ 18/201 0) for a Section 3 request for use on grapes. 

II. Residue Information 

Current Tolerances: The chronic dietary risk assessment was based on the assumption of 

tolerance-level residues. 

Metrafenone is a benzophenone fungicide that reportedly has preventive properties for control of 

powdery mildew produced by Uncinula necator in commercial varieties 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 tolerances are established under 40 CFR §180.624(a) for 

residues ofmetrafenone in/on grape at 4.5 ppm and raisins at 17.0 ppm. 

Recommended Tolerances: The petitioner has proposed new Section 3 uses for: apricot, cherry 

(crop subgroup 12-12A), fruiting vegetables (crop group 8-1 0); fruit, small vine climbing, except 

fuzzy kiwifruit (crop subgroup 13-07F); hops, dried cones; peach (crop subgroup 12-12B), pome 

fruit (crop group 11-1 0); and vegetable, cucurbit, (crop group 9). The chronic dietary risk 

assessment was based on the assumption ofHEO-recommended tolerance level residues as listed 

in Table 1 for the proposed new uses (0407432, D411389, 0414077, 0416465, 0417602, W. 

Drew; July 7, 2014). 

Table 1. RED-Recommended Tolerances 

Commodity HED-Reconunended 

Tolerance (ppm) 

Apricot 0.70 

Cherry subgroup 12-12A 2.0 

Fruit, pome, group 11-10 1.5 

Fruit, small, vine climbing, except fuzzy 4.5 

kiwifruit, subgroup 13-07F 

Hops, cones, dried 70 

Peach subgroup 12-12B 0.70 

Page 3 of 13 
Metrafenone Dietary Exposure and Risk Assessment DP Number: 411390 

Table 1. BED-Recommended Tolerances 

Commodity RED-Recommended 

Tolerance (ppm) 

Vegetable, cucurbit, group 9 0.50 

Vegetables, fruiting, group 8-10 0.90 

Residue Data used for the Chronic Dietary Assessment: 

Residues of Concern (residues included in dietary exposure analysis): For the primary crops, 

metrafenone parent serves as an adequate measure of product misuse based on its percentage of 

the total radioactive residues (TRR) in the metabolism study and the significant residues seen in 

crop field trials. For dietary risk assessment purposes, HED concludes that some of the 

significant amounts of tentatively identified and unidentified material in the grape metabolism 

study needs to be included (the two other metabolism studies with cucumber and wheat were 

similar). The tentatively identified metabolites in the "acetone unknowns" and "juice" fractions 

retain the dual ring structure of the parent compound. Such residues may be of comparable 

toxicity to parent metrafenone. At this time, the residues described as "acetone unknowns" and 

"juice" should be included along with the parent for assessing dietary risk. This approach would 

account for 93% and 77% of the TRR in the grapes harvested after the fifth application of the 

bromophenyl (BP) labeled metrafenone ([bromophenyl-6- 14C]metrafenone) and 

trimethoxyphenyl (TMP) labeled metrafenone ([trimethoxyphenyl-U- 14C]metrafenone), 

respectively. 

Data from the metrafenone grape, cucumber, and wheat metabolism studies were used to derive a 

dietary exposure adjustment factor by dividing residues (as a percent of the TRR) of the parent 

plus the "acetone unknowns" and "juice" fractions by the residue of parent only. Conducting this 

evaluation for both radio labels and both harvesting intervals resulted 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 the "acetone unknowns" and "juice" fractions (see ROCKS Memo, D370903, G. Kramer, 

11119/2009). 

TABLE2. Metrafenone Metabolism Adjustment Factor. 

BP Label TMPLabel Maximum/ Average 

Ratio2 

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% 18% 12.5% 25.3% 

fraction" 

Ratio2 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:afenone Metabolism Adjustment Factor. 

BP Label TMP Label Maximum/ Average 

Ratio2 

Residue (%TRR)1 

No BP Label No BPLabel 14-DATI 3-DAT2 

Metrafenone - -- 12.6% 42.4% 

"Unknowns in polar -- -- 24.0% region" 13.1% 

"Unknowns in -- -- medium polar 41.3% 23.4% 

region" 

Ratio2 -- -- 6.03 2.0 2.0 

Wheat Grain) 

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 

Ratio2 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 

Ratio2 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 

Ratio2 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 

Ratio2 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 because 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 Dietary Exposure and Risk Assessment DP Number: 411390 

used in this assessment, otherwise DEEM-FCIDTM (ver. 7.81) default processing factors are 

assumed. 

Table 3. Metrafenone 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 associated with the proposed metrafenone new uses is 

apple wet pomace, and it is fed only to dairy cattle, at a maximum of 1 0% of the diet. Twelve 

apple field trials were conducted, with a HAFT value of 0.760 ppm for the parent compound. 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 pomace 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, the highest metrafenone 

residue in tissues was in liver at 0.269 ppm. Scaling down to the anticipated dietary burden to 

dairy cattle of 0.228 mg/kg in feed, anticipated metrafenone residues are not expected to exceed 

0.0007 ppm in liver, well below the limit of detection (LOD). Residues would occur at lower 

levels in muscle, fat and milk. There is no reasonable expectation of residues above the limit of 

quantitation (LOQ) of 0.01 ppm in the milk or tissues of ruminant animals. Therefore, tolerances 

in livestock commodities are not required. 

Fish: The USDA Pesticide Data Program (PDP) monitored pesticide residues in catfish in 2008, 

2009, and 2010; however, the samples were not analyzed for metrafenone. As a result, residues 

in fish were not included in the assessment. 

III. Percent Crop Treated Information 

The chronic assessments are based on 100% 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 Fruits, 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 13 
Metrafenone Dietary Exposure and Risk Assessment DP Number: 411390 

The PRZM EXAMS 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 residues of concern for metrafenone indicate that the only identified major 

degradation product is CL 377160 [methanone, (3-bromo-6-methoxy-2-methylphenyl)(3-

hydroxy-2,4-dimethoxy-6-methylphenyl)-]. This degradation product was detected in soil 

photolysis and anaerobic aquatic metabolism studies. Most degradation processes also resulted in 

formation of a substantial amount of minor degradates, some individually measured and 

identified, but most were not. Although all of these degradates were present at less than 1 0%, 

and some at very low levels, these residues may be of exposure concern. In some cases minor 

degradates, mostly unidentified, make up more than 50% of the applied radioactivity in a single 

sampling event. In addition, based on the structure of the parent compound and the proposed 

degradation pathways, many of the minor degradates may have a high degree of structural 

similarity to each other and/or the parent resulting in a similar toxicity profile and cumulative 

effects. Because of the structural similarity of many degradation products with the parent 

compound as well as a high number of unidentified minor degradation products, the drinking 

water assessment (DWA) for metrafenone was conducted 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 

extractable residues (ROCKS Memorandum, 8/29/2009). 

The peak EDWC for total metrafenone residues based on the proposed uses [Pome Fruits, 

Fruiting Vegetables, Peach Subgroup 12-12B, Apricot, Cherry Subgroup 12-12A, Cucurbit 

Vegetables (Group 9), and Fruit, Small, Vine Climbing (except Fuzzy Kiwifruit) Subgroup 13-

07F] is higher than the peak EDWC for the current use on grapes (Table 4). However, the 1-in10-year 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 Metrafenone 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 Vegetables 25.64 7.25 5.71 (Group 9), and Fruit, 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 ground 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) was incorporated directly into these dietary 

assessments under 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/oppefed 1 /models/water/. 

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 pie) are linked to EPA-defined food 

commodities (e.g., apples, peeled fruit - cooked; fresh or N/S; baked; or wheat flour - cooked; 

fresh or N/S, baked) using publicly available recipe translation files developed jointly by 

USDA/ ARS and EPA. For chronic exposure assessment, consumption data are averaged for the 

entire U.S. population and within population subgroups. Based on analysis of the 2003-2008 

WWEIA consumption data, which took into account dietary patterns and survey respondents, 

HED concluded that it is most appropriate to report risk for the following population subgroups: 

the general U.S. population, all infants (<1 year old), children 1-2, children 3-5, children 6-12, 

youth 13-19, adults 20-49, females 13-49, and adults 50-99 years old. 

For a chronic dietary exposure assessment, an estimate of the residue level in each food or foodform (e.g., orange or orange juice) on the food commodity residue list is multiplied by the 

average daily consumption estimate for that food/food form to produce a residue intake estimate. 

The resulting residue intake estimate for each food/food form is summed with the residue intake 

estimates for all other food/food forms on the commodity residue list to arrive at the total average 

estimated exposure. Exposure is expressed in mg/kg body weight/day and as a percent of the 

cPAD. This procedure is performed for each population subgroup. 

VI. Toxicological Information 

HED evaluated 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 metrafenone 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 
Metrafenone Dietary Exposure and Risk Assessment DP Number: 4 11390 

Table S. Summa ry of Toxicological Doses and Endpoints for Use in Dietary H uman Health Risk 

Assessments for Metrafeoone 

Exposure Dose Used in Risk FQPA SF and Level of Study and Toxicological Effects 

Scenario Assessment, UF Concern for Risk 

POD Assessment 

Acute Dietary (All None None No appropriate dose and endpoint could be 

populations, including identified for any population group. 

infants and children) 

Chronic Dietary NOAEL= 24.9 FQPA SF =l Combined Chronic/Carcinogenicity - rat 

(All populations) mg!kglday LOAEL (mglkglday) = 260, based on 

UFA= lOx cP AD = chronic RID hepatotoxicity and nephrotoxicity in both 

UF!F lOx FQPA SF sexes 

Chronic RID = 0.249 

mglkg/day = 0.249 mglkglday 

Cancer (oral, dermal, " Suggestive evidence of carcinogenicity" based on increases in adenomas and adenomas plus 

inhalation) carcinomas in male mice only at I I 09 mglkg/day. The dose at which no increase in tumors was 

noted is 156 mg/kg/day. Quantification of cancer risk is not required. 

Pomt of Departure (POD) = A data potnt or an est1mated potnt that IS dcnved from observed dose.response data and used to mark the begmmng of 

extrapolation to determine risk associated with lower environmentally relevant human exposures. NOAEL = no observed adverse effect level. 

LOAEL = lowest observed adverse effect level. UF = uncertainty factor. UFA = extrapolation from animal to human (interspecies). UF11 = 

potential variation in sensitivity among members of the human population (intraSpecies). FQPA SF= FQPA Safety Factor. PAD = population 

adjusted dose (a= acute, c = chronic). RID • reference dose. 

VII. Results/Discussion 

As stated above, for chronic assessments, HED is concerned when dietary risk exceeds 1 00% of 

the PAD. The DEEM-FCIDTM analysis estimates the dietary exposure of the general U.S. 

population and various population subgroups. Table 6 lists the results of the chronic dietary 

exposure analyses for the general U.S. population, all infants (<1 year old), children 1-2, children 

3-5, children 6-12, youth 13-19, females 13-49, adults 20-49, and adults 50-99 years old. 

Results of Chronic Dietary Exposure Analysis 

In the chronic dietary exposure analysis, the most highly exposed population subgroup is 

Children 1-2 years old whose exposure estimate utilizes 16% ofthe cPAD (Table 6). The 

general U.S. population exposure estimate utilizes 3.7% of the cPAD. 

T able 6. S u mmary of Dietary Exposu re and Risk E stim ates for Metrafenone 

(Food and Drinkin~ Water) 

Acute Dietary Chronic Dietary Cancer 

Dietary Dietary Dietary 

Exposure Exposure Exposure 

Population Subgroup (mglkg/day) o/oaPAD (mglkg/day) o/ocPAD (mglkg/day) 

General U.S. Population 0.009252 3.7 

All Infants{< I year old) 0.035702 14 

C hild ren 1-2 years old 0.040770 16 

Children 3-5 years old 0.024735 9.9 

Children 6-12 years old N/A N/A 0.0 121 36 4.9 N/A 

Youth 13- 19 years old 0.0051 66 2.1 

Adults 20·49 years old 0.006866 2. 8 

Adults 50-99 years old 0.006686 2.7 

Females 13-49 years old 0.005735 2 .3 

N/A - Not applicable. 

Page 9 of 13 

Risk 

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 population subgroups were so low, it was not 

necessary to make refinements to the chronic dietary analysis. If it had been 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, estimates of percent crop treated could have been used. 

Since risk estimates are below HED's level 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 Input File for Chronic Analysis 

Attachment 2: Results of Chronic Dietary Exposure Analysis 

Page 10 of 13 
Metrafenone Dietary Exposure and Risk Assessment DP Number: 411390 

Attachment 1: Residue Input File for Chronic (Non-Cancer) Analysis 

US EPA Ver. 3 . 16, 03 - 08 - d 

DEEM - FCID Chronic analysis for METRAFENONE 

Residue file: J : \Metrafenone\Dietary\METRAFENONE . R08 Adjust. #2 used 

Analysi s Date 07 - 02-201 4 Resi due f i le dated : 07-02- 201 4/10:28:53 

Reference dose (RfD) = 0 . 249 mg/kg bw/day 

Food Crop 

EPA Code Grp Food Name 

1100007000 11 

1100008000 11 

1100008001 1 1 

1100009000 11 

1100009001 11 

1100010000 11 

1100010001 11 

1100011000 11 

1100011001 11 

1202012000 12B 

1 20201 2001 12B 

1 202013000 128 

1 20201 4000 128 

1 20201 4001 128 

0902021000 9B 

0901075000 9A 

0902088000 98 

1201 090000 12A 

1201 090001 12A 

1201 091000 1 2A 

1201 091 001 1 2A 

09 02 102000 98 

1100129000 11 

0 902135000 9B 

08 02148000 8BC 

1 3021 74000 13B 

1304 1 75000 130 

1304 1 76000 130 

13041 76001 130 

95001 77000 0 

9500178000 0 

1304179000 130 

0901187000 9A 

9500188000 0 

110021 0000 11 

1 202230000 128 

0802234000 8BC 

1202260000 12B 

1202260001 12B 

120226 1000 1 28 

1202261001 1 28 

120226 2000 1 2B 

1 202262001 128 

1100266000 11 

1100266001 11 

1 100267000 11 

1100268000 11 

1100268001 11 

0802270000 8B 

0802270001 88 

0802271000 8B 

0802271001 88 

0802272000 8BC 

0802272001 8BC 

0802273000 8BC 

Apple, fruit with peel 

Apple, peeled fruit 

Apple , peeled frui t - babyfood 

Apple, dried 

Apple , dried-babyfood 

Apple, juice 

Apple, juice- babyfood 

Appl e , sauce 

Appl e, sauce- babyfood 

Apricot 

Apricot- babyfood 

Apricot, dried 

Apricot, j uice 

Apricot, j uice-babyf ood 

8a1sam pear 

Cantaloupe 

Chayote, fruit 

Cherry 

Cherry-babyf ood 

Cherry, jui ce 

Che rry, juice- babyfood 

Chi nese waxgourd 

Crabapple 

Cucumber 

Eggplant 

Gooseberry 

Gr ape 

Grape, juice 

Grape , juice- babyfood 

Grape, l eaves 

Grape, raisin 

Grape , wi ne and sherry 

Honeydew melon 

Hop 

Loquat 

Nectarine 

Okra 

Peach 

Peach- babyfood 

Peach, d ried 

Peach, d ried - babyfood 

Peach, j u i ce 

Peach, j uice - babyfood 

Pear 

Pear- babyfood 

Pear, dried 

Pear, juice 

Pear, juice-babyfood 

Peppe r , bell 

Pepp er, bel l-babyfood 

Peppe r, be l l, dried 

Pepper, bel l, dried-babyfood 

Pepper, nonbe l l 

Pepper, nonbel l-babyfood 

Pepper, nonbell, dried 

Page 11 of 13 

Residue 

(ppm) 

1.500000 

1 .500000 

1. 500000 

1. 500000 

1. 500000 

1. 500000 

1 . 500000 

1.500000 

1 .500000 

0.700000 

0. 700000 

0.700000 

0.700000 

0 .700000 

0. 500000 

0 .500000 

0 . 500000 

2 . 000000 

2 . 000000 

2 . 000 000 

2 . 0000 00 

0.500000 

1 . 500000 

0. 500000 

0 .900000 

4 . 500000 

4 . 500000 

4 . 500000 

4 . 500000 

4. 500000 

1 7 . 000000 

4.500000 

0 . 500000 

70.000000 

1 . 500000 

0. 700000 

0.900000 

0.700000 

0.700000 

0.700000 

0.700000 

0 . 700000 

0. 7000 00 

1.500000 

1 . 500000 

1.500000 

1 . 500000 

1 .500000 

0 . 900000 

0.900000 

0 .900000 

0 . 900000 

0 . 90000 0 

0 . 900000 

0 .900000 

Adj . Factor 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 .000 

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 .000 

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 . 000 

2 . 000 

2 . 000 

2 . 000 

2 .00 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 00 

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 

2.000 

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 00 

2.000 

2.000 

2.000 
Metrafenone Dietary Exposure and Risk Assessment DP Number: 411390 

0902 30SOOO 9B Pumpkin 0 .500000 l. 000 2.000 

0902309000 9B Pumpkin, seed 0 . 500000 1 .000 2 . 00 0 

11003 10000 11 Quince 1 . 500000 l. 000 2 . 00 0 

0 9023 56000 9B Squash, summer 0 . 5000 00 1 .000 2 .000 

0 9023560 01 9B Squash, summer- babyfood 0 . 50000 0 l. 000 2.000 

0 90 23 570 00 9B Squash, wint er 0 . 50000 0 1 . 000 2 .000 

0 9023570 01 9B Squash, wi n t er- b abyfood 0 . 500000 l. 000 2.000 

OS01 3740 00 SA Tomati1lo 0 . 900000 1. 0 00 2.000 

OS 01375000 SA Tomato 0 . 900000 1 . 0 00 2 .000 

OS013 750 0 1 SA Tomato- babyfood 0 . 9000 00 1 . 0 00 2 .000 

OS0137600 0 SA Toma to, paste 0.900000 0 . 4 00 2. 00 0 

OS0137600 1 SA Toma to, past e - babyfood 0.900000 0 . 40 0 2 . 00 0 

OS01377000 SA Tomato, puree 0.900000 0.950 2. 00 0 

OS01 377001 SA Toma t o, puree- babyfood 0. 90 00 00 0 .950 2 . 00 0 

OS0137SOOO SA Tomato, dried 0 . 900000 14. 300 2.000 

OS01 37S001 SA Tomato, dried - babyf ood 0 . 900000 1 4. 300 2.000 

OS01 379 000 SA Toma to, juice 0 . 900000 0 . 330 2. 00 0 

OS0 13SOOOO SA Toma to , Tree 0 . 900 000 1. 000 2. 0 00 

S601 000 000 S6A Water, direct, all sources 0 . 01 452 0 1. 000 1. 0 00 

S6 0 2000 000 S6B Water, i ndi r ect, a ll s ources 0 . 01 4520 1. 000 1. 000 

0901399000 9A wa t ermelon 0 . 500000 1. 000 2.000 

0901400000 9A Watermelon , j u i c e 0 . 500000 1. 000 2.000 

1100173500 11 Goj i b err y 0 . 900 000 1. 000 2.000 

Page 12of 13 
Metrafenone Dietary Exposure and Risk Assessment 

Attachment 2: Results of Chronic Dietary Exposure Analysis 

US EPA 

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) = .249 mg/kg bw/day 

Population 

Subgroup 

Total us Population 

Hispanic 

Non- Hisp- White 

Non- Hisp-Black 

Non-Hisp-Other 

Nursing Infants 

Non- Nursing Infants 

Female 13+ PREG 

Children 1-6 

Children 7-12 

Male 13-19 

Female 13-19/NP 

Male 20+ 

Female 20+/NP 

Seniors 55+ 

All Infants 

Female 13-50 

Children 1-2 

Children 3 - 5 

Children 6 - 12 

Youth 13 - 19 

Adults 20-49 

Adults 50- 99 

Female 13-49 

Total exposure by population subgroup 

Total Exposure 

mg/kg 

body wt/day 

0.009252 

0.00954 1 

0 .009446 

0.007765 

0.009423 

0.026030 

0.040022 

0. 006110 

0.029855 

0 .010529 

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 

Rfd 

3 .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%