Fenamidone (046679) Dietary Exposure and Risk Assessment D391040

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### 0.17

UNITED STATES ENVIRONMEN TAL PROTECTION AGENCY

WASHINGTON, D.C. 20460

OFFICE OF CHEMICAL SAFETY AND POLLUTION PREVENTION 

### MEMORANDUM

DATE: July 7, 2011

SUBJECT: Fenamidone – Acute and Chronic Aggregate Dietary (Food and Drinking Water) Exposure and Risk Assessments to Support the Label Amendment to Permit Rotation to All Cereal Grain, Except Rice and Establish Revised Tolerances for Inadvertent Residues.

PC Code: 046679 DP Barcode: D391040 MRID No.: None Registration No.: 264-695 Petition No.: 0F7764 Regulatory Action: Section 3 Registration Assessment Type: Dietary Risk Assessment Reregistration Case No.: N/A
T XR No.: N/A CAS No.: 161326-34-7



### REVIEWER: Alexandra LaMay, Biologist Risk Assessment Branch VII Health Effects Division (7509P)

THROUGH: Rebecca Daiss, Biologist Sheila Piper, Chemist Dietary Exposure Science Advisory Council (DESAC) Health Effects Division (7509P) and Michael S. Metzger, Chief Risk Assessment Branch VII Health Effects Division (7509P)

To: Rosemary Kearns Tony Kish, PM 22 Registration Division (7505P)Fenamidone (046679) Dietary Exposure and Risk Assessment D391040

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### Executive Summary

Acute and chronic aggregat e dietary (food and drinking water) exposure and risk assessments were conducted using the Di etary Exposure Evaluation Model DEEMFCIDTM, Version 2.03 which use food consumption data from the U.S. Department of Agriculture’s Continuing Surveys of F ood Intakes by Individuals (CSFII) from 1994- 1996 and 1998. The analyses were performed to support the Section 3 request to allow rotation to all crops, ex cept rice, in the cerea l crop groups (crop gr oups 15, except rice and crop group 16, except rice).

Acute Dietary (Food and Drinking Water) Ex posure Results and Characterization A conservative acute dietary risk assessmen t was conducted which used maximum field trial residue values, assumed 100 percent crop treated (% CT) for all commodities, incorporated DEEMTM default processing factors for many processed commodities and included modeled drinking water estimates. The estimated exposure (food and water) to the U.S. population from the existing and propos ed new uses of fenamidone resulted in an estimated risk equivalent to 3% of the acute population adjusted dose (aPAD) at the 95 th 

### percentile. The most highly exposed subpop ulation was children 1 - 2 years with an estimated exposure equivalent to 5% of the aPAD at the 95 th 

### percentile.

Chronic Dietary (Food and Drinking Water) Exposure Results and Characterization A conservative chronic dietary risk asse ssments was conducted which used maximum field trial residue values, assumed 100 % CT for all commodities, incorporated DEEMTM default processing factors for many processed commodities and included modeled drinking water estimates. The estimated exposure (food and water) to the U.S. population from the existing and proposed ne w uses of fenamidone resulted in an estimated risk equivalent to 52% of the ch ronic population adjust ed dose (cPAD). The most highly exposed subpopulation was childre n 1 – 2 years with an estimated exposure equivalent to 90% of the cPAD.

Cancer Dietary (Food and Drinking Water) Exposure Results and Characterization Fenamidone is not likely to be a human car cinogen; therefore a ca ncer dietary risk assessment is not required for this chemical.

I. Introduction

Dietary risk assessment incorpor ates 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 dose which HED ha s concluded will result in no unreasonable adverse health effects). This dose is refe rred to as the population adjusted dose (PAD). The PAD is equivalent to point of depart ure (POD, NOAEL, LOAEL, e.g.) divided by the required uncertainty or safety factors.

For acute and non-cancer chroni c exposures, HED is concerned when estimated dietary risk exceeds 100% of the PAD. HED is gene rally concerned when estimated cancer risk exceeds one in one million. References which discuss the acute and chronic riskFenamidone (046679) Dietary Exposure and Risk Assessment D391040

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### assessments in more detail are available on the EPA/pesticides web site: “Available Information on Assessing Exposure from Pesticides, A User’s Guide,” 21-JUN-2000, web link: http://www.epa.gov/fedrgstr/E PA-PEST/2000/July/Day-12/6061.pdf ; or see SOP 99.6 (20-AUG-1999).

The most recent dietary risk assessment fo r fenamidone was conducted by Donna Davis (D362172, 2/23/09).

II. Residue Information

Tolerances are currently estab lished for residues of fenamidone per se under 40 CFR 180.579 (a)(1) for a variety of primary cr ops including bulb vegetables, cucurbit vegetables, tuberous and corm vegetables, br assica vegetables, leafy vegetables, fruiting vegetables, cotton, non bell pepper, sunflowe r, and tomato ranging from 0.02 ppm to 60 ppm. Animal commodity tolerances are esta blished for residues of fenamidone and RPA 717879 (DADK-Fen) in milk, fat, meat a nd meat byproducts under 180.579(a)(2). Rotational crop tolerances are establishe d for residues of fenamidone and RPA 717870 (DADK-Fen) in wheat, corn and soybean co mmodities and strawberries ranging from 0.02 ppm to 0.50 ppm under 40CFR 180.579(d).

The residues of concern for tolerance setting and risk assessment purposes are summarized in the table below.

Table 1: Residues of Concern in Primary Crops, Livestock, Rotational Crops, and Water
Matrix Tolerance Expression Residues for Risk Assessment Registered/proposed primary crops excluding root vegetables fenamidone fenamidone, RPA 717879 (DADK-Fen), RPA 408056 (DA-Fen), RPA 405862 Root vegetables fena midone fenamidone, RPA 413255

Animal commodities fenamidone, RPA 717879 (DADK-Fen) fenamidone, RPA 717879 (DADK-Fen), RPA 408056 (DA-Fen)

Rotational Crops fenamidone, RPA 717879 (DADK-Fen) fenamidone, RPA 717879 (DADK-Fen), and RPA 408056 (DA-Fen) (free and conjugated)

Water NA Fenamidone, RPA 412636, RPA 412708, RPA 411639, RPA 413255, RPA 409446, and RPA 410995



### Residue Data used for Acute and Chronic Assessments Since the residue of concern for toleran ce setting purposes and for risk assessment differs, HED has not used tolerance level re sidues for these assessments. Residues for plant commodities are based on maximum field tr ial values of parent plus metabolites. For animal commodities, LOQ residues are assumed as detailed in the T. Bloem memorandum dated 7/14/07 (D336201). No new residue data were submitted to support the new rotational crop toleran ces on cereal grains (crop gr oup 15 and 16, except rice). Therefore, residues for dietary risk assessm ent for these rotational crops were derived based on translation from existi ng rotational crop field trials data for wheat and corn. However, since the analytical method used to detect residues of fenamidone was not validated for detection of DA-Fen conjugate; HED has derived a ratio between residues of DADK-Fen and the DA-Fen conjugate base d on available rotational crop metabolismFenamidone (046679) Dietary Exposure and Risk Assessment D391040

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### data. That ratio is applied to the DADK-Fen residues from the rotational crop field trials and then added to total parent and DADK- Fen residues directly measured in the rotational field trial data to estimate total residues of concern in rotational crops. The new rotational crop residues were included in the acute and chronic dietary risk assessment and a description of how they we re calculated are shown in Table 2.

DEEM  (ver. 7.81) default processing factors were maintained for all commodities excluding grape juice, dried potato, tomato pa ste, tomato puree, field corn processed commodities and soybean processed commod ities. For these co mmodities, the DEEM  default processing factors were reduced to 1 based on processing data (grape), were reduced to 1 based on the appli cation of empirical processing factors to the RAC residue (tomato paste, tomato puree, and dried pot ato; D277818, T. Bloem, 4/22/04), or were reduced to 1 based on lack of residues at exaggerated rates in the RAC (field corn processed commodities and soybean pr ocessed commodities; D357372, A. LaMay, 2/24/09).

For all commodities, 100 percent crop treated was assumed.

Table 2. Summary of New Residue Values Added to the Acute and Chronic Dietary Risk Assessment

Crop/Commodity* Residue Value (ppm) Comment

Cereal grains, Crop Group 15 and 16 (except rice) which includes: barley, buckwheat, corn [pop], millet, oats, rye, sorghum, teosinte, triticale, wheat. 0.594 Translated from wheat data. The field rotational crop studies monitored for resi dues of fenamidone, RPA 717879, and free RPA 408056 with a highest combined residues in wheat grain of 0.075 ppm; residues of conjugated RPA 408056 were estimated in wheat grain using the conjugated RPA 408056:RPA 717879 residue ratio for wheat grain from the confined rotational crop study (30-day PBI ratio = 8.5) and the max RPA 717879 residue (0.061 ppm) from the field rotational crop studies (0.075 + 0.061 x 8.5 = 0.594 ppm; D281887, T. Bloem, 18-Jul-2002)

Field Corn and processed commodities 0.218 Maximum rotational crop field corn residue data reported <0.02 ppm for fenamidone and <0.02 ppm for combined residues of RPA 717879 and RPA 405862 (free). Residues of conjugated RPA 405862 were not reported, but are a residue of concern in rotational crops. Residues of RPA 405862 were 8.5x residues of RPA 717879 from the wheat confined rotational crop study. Total residue of concern for field corn and processed commodities is calculated as 0.02 ppm (fenamidone) + 0.02 ppm (RPA 717879 and free RPA 405862) + 0.02 x 8.9 (ratio to yield conjugated RPA 405862) = 0.218 (D357372, A. LaMay, 2/24/09).

Sweet Corn (K + CWHR) 0.218 Maximum rotational crop swee t corn (K+CWHR) residue data reported <0.02 ppm for fenamidone and <0.02 ppm for combined residues of RPA 717879 and RPA 405862 (free). Residues of conjugated RPA 405862 were not reported, but are a residue of concern in rotational crops. Residues of RPA 405862 were 8.5x residues of RPA 717879 from the wheat confined rotational crop study. Total residue of concern for sweet corn (K+CWHR) is calculated as 0.02 ppm (fenamidone) + 0.02 ppm (RPA 717879 and free RPA 405862) + 0.02 x 8.9 (ratio to yield conjugated RPA 405862) = 0.218 (D357372, A. LaMay, 2/24/09).Fenamidone (046679) Dietary Exposure and Risk Assessment D391040

Page 5 of 15 *Although there are not separate tolera nces for the cereal grains, the residue data for corn were used in the dietary assessment since specific residue data are ava ilable for these crops. Residue data for wheat were used for all other cereal grains for th e purposes of the dietary assessment.



### III. Drinking Water Data

The drinking water residues used in the di etary risk assessment were provided by the Environmental Fate and Effects Divisi on (EFED) in the following memorandum: “Fenamidone - Interregional Research Project No. 4 (PR#07975, 08164) Drinking Water Assessment for Total Residues in Surface and [Ground] Water for Uses on Root vegetables (except sugar beet; Subgroup 1B , except radishes), okra, turnip greens, cilantro, and grapes East of the Rockie s” (James Hetrick, D352807, 10/9/08) and were incorporated directly into the acute and chr onic dietary assessments. Water residues were incorporated in the DEEM-FCID into the f ood categories “water, direct, all sources” and “water, indirect, all sources.”

Monitoring data are not availabl e for residues of fenamidone and its metabolites in water; therefore EFED has provided modeled va lues for ground and surface water. The modeled EDWCs (estimated drinking water c oncentrations) are repo rted for parent and its degradation products, RPA-41263 6, RPA-412108, RPA-411639, RPA-413255, RPA409446, and RPA- 410995. These are the residues of concern in drinking water, as determined by the Metabolite Assessment Committee (MARC, 05/25/04). Surface water EDWCs were calculated using a Tier II m odel for surface water PRZM (Version 3.122) and EXAMS (Version 2.98.04) using the PE5 platform. The EDWC in ground water were estimated using SCI-GROW (Version 2.3). EDWCs in surface source water were corrected using the default pe rcent crop area factor (0.87). The default PCA was applied because fenamidone can be used on numerous crops. No water treatment effects were considered in this assessment. These models and their descriptions are available at the EPA internet site: http://www.epa.gov/oppefed1/models/water/

.

The maximum Tier II EDWCs of total fenamidone residues in surface source water are not expected to exceed 47.88 μ g/L for the 1 in 10 year da ily peak concentration, 12.86

μ g/L for the 1 in 10 year annual average concentration, and 6.89 μ g/L for the 30 year annual average concentration. The maximum co ncentration of total fenamidone residues in shallow groundwater are not expected to exceed 178 μ g/L. For both the acute and chronic dietary anal ysis, HED will use the maximum ground water EDWC of 178 μ g/L (0.178 ppm), since it is the highe st EDWC reported for fenamidone.

IV. DEEM-FCIDTM Program and Consumption Information

Fenamidone acute and chronic dietary expos ure assessments were conducted using the Dietary Exposure Evaluation Model software with the Food Commodity Intake Database DEEM-FCIDTM, Version 2.03 which incorpor ates consumption data from USDA’s Continuing Surveys of Food Intakes by I ndividuals (CSFII), 1994-1996 and 1998. The 1994-96, 98 data are based on the reported cons umption of more than 20,000 individuals over two non-consecutive survey days. Foods “as consumed” (e.g., apple pie) are linkedFenamidone (046679) Dietary Exposure and Risk Assessment D391040

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### to EPA-defined food commodities (e.g. apples, peel ed 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 ch ronic exposure assessment, consumption data are averaged for the en tire U.S. population a nd within population subgroups, but for acute exposure assessment are retained as i ndividual consumption events. Based on analysis of the 1994-96, 98 CSFII consumption data, which took into account dietary patterns and survey res pondents, HED concluded that it is most appropriate to report risk for the follo wing population subgroups: the general U.S. population, all infants (<1 year old), child ren 1-2, children 3-5, children 6-12, youth 13- 19, adults 20-49, females 13-49, and adults 50+ years old.

For chronic dietary exposure assessment, an es timate of the residue level in each food or food-form (e.g., orange or orange juice) on th e food commodity residue list is multiplied by the average daily consumption estimate fo r 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 av erage 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.

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 a nd summed to obtain a total daily pesticide exposure for a deterministic exposure asse ssment, or “matched” in multiple random pairings with residue values and then summed in a probabilistic assessment. The resulting distribution of expos ures is expressed as a perc entage of the aPAD on both a user (i.e., only those who reported eating relevant commodities/food forms) and a percapita (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 for all tiers of analysis. However, for tiers 1 and 2, any significant differences in user vs. per capita exposure and risk are sp ecifically identified and noted in the risk assessment.

V. Toxicological Information

The HED Hazard Identification and Assessm ent Review Committee (HIARC) met on 18- March-2003 to evaluate the toxicological database for fenamidone (TXR No. 0052379). At that meeting the lack of a developmenta l neurotoxicity study was indentified and a 10X database uncertainty factor was applied. Subsequent to that finding, the registrant has addressed the data gap, and HED has dete rmined that the database UF is no longer required. Based on toxicological considerations and the residue assumptions used in the dietary analyses, HED concludes that the FQPA Safety Factor can be reduced to 1x when assessing acute and chronic dietary exposures. Table 3 summarizes the points of departure used for diet ary risk assessment.

Table 3. Summary of Toxicological Doses and En dpoints for Fenamidone Di etary Exposure AssessmentFenamidone (046679) Dietary Exposure and Risk Assessment D391040

Page 7 of 15 Exposure Scenario Point of Departure Uncertainty/ FQPA SF RfD and PAD Study and Toxicological Effects

Acute Dietary (All populations) NOAEL = 125 mg/kg/day UF A = 10x
UF H = 10x FQPA SF= 1 Acute RfD = 1.25 mg/kg/day

Acute PAD = 1.25 mg/kg/day Acute Neurotoxicity in Rats; LOAEL = 500 mg/kg/day based on urination, staining/soiling of the anogenital region, mucous in the feces, and unsteady gait in the females

Chronic Dietary (All populations) NOAEL= 2.83 mg/kg/day UF A = 10x
UF H = 10x FQPA SF= 1 Chronic RfD = 0.0283 mg/kg/day

Chronic PAD = 0.0283 mg/kg/day 2 Year Chronic Toxicity /Carcinogenicity in Rats; LOAEL = 7.07/9.24 mg/kg/day (M/F) based on increase in severity of diffuse thyroid C-cell hyperplasia in both

sexes

Cancer Based on the negative carcinogenic po tential of fenamidone in rats and mice, the HI ARC classified fenamidone as “not likely” to be a human carcinogen by al l relevant routes of exposure.

Point of Departure (POD) = A data point or an estimated point that is derived from obs erved dose-response data and used to mar k the beginning of extrapolation to determine risk associated with lower environmenta lly relevant human exposures. NOAEL = no observed adverse effect level. LOAEL = lowest observed adverse effect level. UF = uncertainty factor. UF A = extrapolation from animal to human (intraspecies). UF H = potential variation in sensitivity among member s of the human population (interspecies). FQPA SF = FQPA Safety Factor. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose.



### VI. Results/Discussion

As stated above, for acute and chronic assessments, HED is concerned when dietary risk exceeds 100% of the PAD. The DEEM-FCIDTM analyses estimate the dietary exposure of the U.S. population and various population subgroups. The results reported in Table 4 are for the general U.S. Population, all infa nts (<1 year old), children 1-2, children 3-5, children 6-12, youth 13-19, females 13-49, a dults 20-49, and adults 50+ years.

Results of Acute Dietary (Food and Drinking Water) Exposure Analysis The estimated exposure (food and water) to the U.S. population from the existing and proposed new uses of fenamidone resulted in an estimated risk equivalent to 3% of the aPAD at the 95 th 

### percentile. The most highly expos ed subpopulation was children 1 – 2 years with an estimated exposure equi valent to 5% of the aPAD at the 95 th 

### percentile. The results of the acute dietary assessment for all population subgroups are shown in the Table 4, below.

Results of Chronic Dietary (Food an d Drinking Water) Exposure Analysis The estimated exposure (food and water) to the U.S. population from the existing and proposed new uses of fenamidone resulted in an estimated risk equivalent to 52% of the coped. The most highly exposed subpopulat ion was children 1 – 2 years with an estimated exposure equivale nt to 90% of the cPAD.

The results of the chronic dietary exposure an alysis are reported in the summary table below (Table 4).

Results of Cancer Dietary (Food a nd Drinking Water) Exposure Analysis Fenamidone is not likely to be a human carcinogen; therefore a cancer dietary risk assessment is not required for this chemical.Fenamidone (046679) Dietary Exposure and Risk Assessment D391040

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### Table 4. Summary of Dietary 

### (Food and Drinking Water) Exposure and Risk for Fenamidone

Population Subgroup Acute Dietary (95th Percentile) Chronic Dietary Cancer

Dietary Exposure (mg/kg/day) % aPAD* Dietary Exposure (mg/kg/day) % cPAD* Dietary Exposure (mg/kg/day) Risk

General U.S. Population 0.041808 3 0.014569 52 N/A N/A

All Infants (< 1 year old) 0.049304 4 0.021887 77

N/A N/A Children 1-2 years old 0.062898 5 0.025420 90

Children 3-5 years old 0.057048 5 0.022859 81

Children 6-12 years old 0.043157 3 0.015630 55

Youth 13-19 years old 0.035613 3 0.011796 42

Adults 20-49 years old 0.038559 3 0.013340 47

Adults 50+ years old 0.041256 3 0.014109 50

Females 13-49 years old 0.040734 3 0.013388 47
N/A is “not applicable”. Populations w ith highest exposure are shown in bold. * PAD = population adjusted dose.



### VII. Characterization of Inputs/Outputs

The acute and chronic dietary assessments are considered to be c onservative, using high end field trial data and assuming 100% CT fo r all commodities, as well as using default drying concentration factors. The results of the acute and chronic dietary risk assessments are unlikely to underestimate risk.

VIII. Conclusions

Conservative acute and chr onic dietary risk assessments were conducted which used maximum field trial residue values, a ssumed 100 % CT for all commodities and incorporated DEEMTM default processing factors for many processed commodities.

The estimated exposure (food and water) to the U.S. population from the existing and proposed new uses of fenamidone resulted in an estimated risk equivalent to 3% of the aPAD at the 95 th 

### percentile. The most highly expos ed subpopulation was children 1 – 2 years with an estimated exposure equi valent to 5% of the aPAD at the 95 th 

### percentile.

The estimated exposure (food and water) to the U.S. population from the existing and proposed new uses of fenamidone resulted in an estimated risk equivalent to 52% of theFenamidone (046679) Dietary Exposure and Risk Assessment D391040

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### cPAD. The most highly exposed subpopulat ion was children 1 – 2 years with an estimated exposure equivale nt to 90% of the cPAD.

Acute and chronic dietary risks from th e existing and newly proposed used of fenamidone are not of concern.

IX. List of Attachments

Attachment 1. Acute and Chronic F ood plus Water Residue Input file. Attachment 2. Acute Dietary Risk Assessment Results file. Attachment 3. Chronic Dietary Risk Assessment Results file.Fenamidone (046679) Dietary Exposure and Risk Assessment D391040

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### Attachment 1. Fenamidone Acute and Chr onic Food plus Water Residue Input File

U.S. Environmental Protection Agency Ver. 2.00 DEEM-FCID Chronic analysis for FENAMIDONE 1994-98 data Residue file: C:\Documents and Settings\ALEMAY\My Documents\Fenamidone- group 15 and 16\Dietary\DEEM files\fenamidone acute and chronic f_w032311.R98 Adjust. #2 NOT used Analysis Date 03-23-2011 Residue file dated: 03-23-2011/10:30:44/8 Reference dose (RfD) = 0.0283 mg/kg bw/day Comment:100x uncertainty factor for acute and chronic; 1x FQPA safety factor for acute and chronic

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

- Food Crop Residue Adj.Factors

Comment EPA Code Grp Food Name (ppm) #1 #2

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

------- 04010050 4A Amaranth, leafy 32.550000 1.000 1.000 01030150 1CD Arrowroot, flour 0.080000 1.000 1.000 01030151 1CD Arrowroot, flour-babyfood 0.080000 1.000 1.000 01030170 1CD Artichoke, Jerusalem 0.080000 1.000 1.000 04010180 4A Arugula 32.550000 1.000 1.000 09020210 9B Balsam pear 0.158000 1.000 1.000 15000250 15 Barley, pearled barley 0.594000 1.000 1.000 15000251 15 Barley, pearled barley-babyfood 0.594000 1.000 1.000 15000260 15 Barley, flour 0.594000 1.000 1.000 15000261 15 Barley, flour-babyfood 0.594000 1.000 1.000 15000270 15 Barley, bran 0.594000 1.000 1.000 21000440 M Beef, meat 0.150000 1.000 1.000 21000441 M Beef, meat-babyfood 0.150000 1.000 1.000 21000450 M Beef, meat, dried 0.150000 1.920 1.000 21000460 M Beef, meat byproducts 0.150000 1.000 1.000 21000461 M Beef, meat byproducts-babyfood 0.150000 1.000 1.000 21000470 M Beef, fat 0.150000 1.000 1.000 21000471 M Beef,fat-babyfood 0.150000 1.000 1.000 21000480 M Beef, kidney 0.150000 1.000 1.000 21000490 M Beef, liver 0.150000 1.000 1.000 21000491 M Beef, liver-babyfood 0.150000 1.000 1.000 01010500 1AB Beet, garden, roots 0.180000 1.000 1.000 01010501 1AB Beet, garden, roots-babyfood 0.180000 1.000 1.000 05010610 5A Broccoli 3.270000 1.000 1.000 05010611 5A Broccoli-babyfood 3.270000 1.000 1.000 05010620 5A Broccoli, Chinese 3.270000 1.000 1.000 05020630 5B Broccoli raab 32.990000 1.000 1.000 05010640 5A Brussels sprouts 0.740000 1.000 1.000
15000650 15 Buckwheat 0.594000 1.000 1.000 15000660 15 Buckwheat, flour 0.594000 1.000 1.000
01010670 1AB Burdock 0.180000 1.000 1.000 05010690 5A Cabbage 0.740000 1.000 1.000 05020700 5B Cabbage, Chinese, bok choy 32.990000 1.000 1.000 05010710 5A Cabbage, Chinese, napa 0.740000 1.000 1.000 05010720 5A Cabbage, Chinese, mustard 3.270000 1.000 1.000 09010750 9A Cantaloupe 0.158000 1.000 1.000
04020760 4B Cardoon 20.160000 1.000 1.000
01010780 1AB Carrot 0.180000 1.000 1.000 01010781 1AB Carrot-babyfood 0.180000 1.000 1.000 01010790 1AB Carrot, juice 0.180000 1.000 1.000
09010800 9A Casaba 0.158000 1.000 1.000
01030820 1CD Cassava 0.080000 1.000 1.000 01030821 1CD Cassava-babyfood 0.080000 1.000 1.000Fenamidone (046679) Dietary Exposure and Risk Assessment D391040

Page 11 of 15 05010830 5A Cauliflower 3.270000 1.000 1.000 01010840 1AB Celeriac 0.180000 1.000 1.000 04020850 4B Celery 20.160000 1.000 1.000 04020851 4B Celery-babyfood 20.160000 1.000 1.000 04020860 4B Celery, juice 20.160000 1.000 1.000
04020870 4B Celtuce 20.160000 1.000 1.000 09020880 9B Chayote, fruit 0.158000 1.000 1.000 01011000 1AB Chicory, roots 0.180000 1.000 1.000 09021020 9B Chinese waxgourd 0.158000 1.000 1.000 04011040 4A Chrysanthemum, garland 32.550000 1.000 1.000
05021170 5B Collards 32.990000 1.000 1.000 15001200 15 Corn, field, flour 0.218000 1.000 1.000 15001201 15 Corn, field, flour-babyfood 0.218000 1.000 1.000 15001210 15 Corn, field, meal 0.218000 1.000 1.000 15001211 15 Corn, field, meal-babyfood 0.218000 1.000 1.000 15001220 15 Corn, field, bran 0.218000 1.000 1.000 15001230 15 Corn, field, starch 0.218000 1.000 1.000 15001231 15 Corn, field, starch-babyfood 0.218000 1.000 1.000 15001240 15 Corn, field, syrup 0.218000 1.000 1.000 15001241 15 Corn, field, syrup-babyfood 0.218000 1.000 1.000 15001250 15 Corn, field, oil 0.218000 1.000 1.000 15001251 15 Corn, field, oil-babyfood 0.218000 1.000 1.000 15001260 15 Corn, pop 0.594000 1.000 1.000 15001270 15 Corn, sweet 0.218000 1.000 1.000 15001271 15 Corn, sweet-babyfood 0.218000 1.000 1.000 95001280 O Cottonseed, oil 0.080000 1.000 1.000 95001281 O Cottonseed, oil-babyfood 0.080000 1.000 1.000 04011330 4A Cress, garden 32.550000 1.000 1.000 04011340 4A Cress, upland 32.550000 1.000 1.000
09021350 9B Cucumber 0.158000 1.000 1.000 04011380 4A Dandelion, leaves 32.550000 1.000 1.000 01031390 1CD Dasheen, corm 0.080000 1.000 1.000 08001480 8 Eggplant 0.260000 1.000 1.000 04011500 4A Endive 32.550000 1.000 1.000 04021520 4B Fennel, Florence 20.160000 1.000 1.000 03001640 3 Garlic 0.186000 1.000 1.000 03001650 3 Garlic, dried 0.186000 1.000 1.000 03001651 3 Garlic, dried-babyfood 0.186000 1.000 1.000 01031660 1CD Ginger 0.080000 1.000 1.000 01031661 1CD Ginger-babyfood 0.080000 1.000 1.000 01031670 1CD Ginger, dried 0.080000 1.000 1.000 01011680 1AB Ginseng, dried 0.180000 1.000 1.000 23001690 M Goat, meat 0.150000 1.000 1.000 23001700 M Goat, meat byproducts 0.150000 1.000 1.000 23001710 M Goat, fat 0.150000 1.000 1.000 23001720 M Goat, kidney 0.150000 1.000 1.000 23001730 M Goat, liver 0.150000 1.000 1.000 95001750 O Grape 0.896000 1.000 1.000 95001760 O Grape, juice 0.896000 1.000 1.000 95001761 O Grape, juice-babyfood 0.896000 1.000 1.000 95001770 O Grape, leaves 0.896000 1.000 1.000 95001780 O Grape, raisin 0.896000 4.300 1.000 95001790 O Grape, wine and sherry 0.896000 1.000 1.000 09011870 9A Honeydew melon 0.158000 1.000 1.000 24001890 M Horse, meat 0.150000 1.000 1.000 01011900 1AB Horseradish 0.180000 1.000 1.000
05021940 5B Kale 32.990000 1.000 1.000 05011960 5A Kohlrabi 0.740000 1.000 1.000
03001980 3 Leek 1.234000 1.000 1.000 04012040 4A Lettuce, head 11.790000 1.000 1.000 04012050 4A Lettuce, leaf 17.580000 1.000 1.000 28002210 M Meat, game 0.150000 1.000 1.000 27002220 D Milk, fat 0.030000 1.000 1.000Fenamidone (046679) Dietary Exposure and Risk Assessment D391040

Page 12 of 15 27002221 D Milk, fat - baby food/infant for 0.030000 1.000 1.000 27012230 D Milk, nonfat solids 0.030000 1.000 1.000 27012231 D Milk, nonfat solids-baby food/in 0.030000 1.000 1.000 27022240 D Milk, water 0.030000 1.000 1.000 27022241 D Milk, water-babyfood/infant form 0.030000 1.000 1.000 27032251 D Milk, sugar (lactose)-baby food/ 0.030000 1.000 1.000 15002260 15 Millet, grain 0.594000 1.000 1.000 05022290 5B Mustard greens 32.990000 1.000 1.000 15002310 15 Oat, bran 0.594000 1.000 1.000 15002320 15 Oat, flour 0.594000 1.000 1.000 15002321 15 Oat, flour-babyfood 0.594000 1.000 1.000 15002330 15 Oat, groats/rolled oats 0.594000 1.000 1.000 15002331 15 Oat, groats/rolled oats-babyfood 0.594000 1.000 1.000
08002340 8 Okra 1.780000 1.000 1.000 03002370 3 Onion, dry bulb 0.186000 1.000 1.000 03002371 3 Onion, dry bulb-babyfood 0.186000 1.000 1.000 03002380 3 Onion, dry bulb, dried 0.186000 9.000 1.000 03002381 3 Onion, dry bulb, dried-babyfood 0.186000 9.000 1.000 03002390 3 Onion, green 1.234000 1.000 1.000 04012480 4A Parsley, leaves 32.550000 1.000 1.000 01012500 1AB Parsley, turnip rooted 0.180000 1.000 1.000 01012510 1AB Parsnip 0.180000 1.000 1.000 01012511 1AB Parsnip-babyfood 0.180000 1.000 1.000 08002700 8 Pepper, bell 0.260000 1.000 1.000 08002701 8 Pepper, bell-babyfood 0.260000 1.000 1.000 08002710 8 Pepper, bell, dried 0.260000 1.000 1.000 08002711 8 Pepper, bell, dried-babyfood 0.260000 1.000 1.000 08002720 8 Pepper, nonbell 1.780000 1.000 1.000 08002721 8 Pepper, nonbell-babyfood 1.780000 1.000 1.000 08002730 8 Pepper, nonbell, dried 1.780000 1.000 1.000 01032960 1C Potato, chips 0.080000 1.000 1.000 01032970 1C Potato, dry (granules/ flakes) 0.104000 1.000 1.000 01032971 1C Potato, dry (granules/ flakes)-b 0.104000 1.000 1.000 01032980 1C Potato, flour 0.104000 1.000 1.000 01032981 1C Potato, flour-babyfood 0.104000 1.000 1.000 01032990 1C Potato, tuber, w/peel 0.080000 1.000 1.000 01032991 1C Potato, tuber, w/peel-babyfood 0.080000 1.000 1.000 01033000 1C Potato, tuber, w/o peel 0.080000 1.000 1.000 01033001 1C Potato, tuber, w/o peel-babyfood 0.080000 1.000 1.000 09023080 9B Pumpkin 0.158000 1.000 1.000 09023090 9B Pumpkin, seed 0.158000 1.000 1.000 29003120 M Rabbit, meat 0.150000 1.000 1.000 04013130 4A Radicchio 11.790000 1.000 1.000 01013140 1AB Radish, roots 0.180000 1.000 1.000 01013160 1AB Radish, Oriental, roots 0.180000 1.000 1.000 05023180 5B Rape greens 32.990000 1.000 1.000
04023220 4B Rhubarb 20.160000 1.000 1.000 01013270 1AB Rutabaga 0.180000 1.000 1.000 15003280 15 Rye, grain 0.594000 1.000 1.000 15003290 15 Rye, flour 0.594000 1.000 1.000 01013310 1AB Salsify, roots 0.180000 1.000 1.000
03003380 3 Shallot 0.186000 1.000 1.000 26003390 M Sheep, meat 0.150000 1.000 1.000 26003391 M Sheep, meat-babyfood 0.150000 1.000 1.000 26003400 M Sheep, meat byproducts 0.150000 1.000 1.000 26003410 M Sheep, fat 0.150000 1.000 1.000 26003411 M Sheep, fat-babyfood 0.150000 1.000 1.000 26003420 M Sheep, kidney 0.150000 1.000 1.000 26003430 M Sheep, liver 0.150000 1.000 1.000 15003440 15 Sorghum, grain 0.594000 1.000 1.000 15003450 15 Sorghum, syrup 0.594000 1.000 1.000 06003470 6 Soybean, seed 0.232000 1.000 1.000 06003480 6 Soybean, flour 0.232000 1.000 1.000Fenamidone (046679) Dietary Exposure and Risk Assessment D391040

Page 13 of 15 06003481 6 Soybean, flour-babyfood 0.232000 1.000 1.000 06003490 6 Soybean, soy milk 0.232000 1.000 1.000 06003491 6 Soybean, soy milk-babyfood or in 0.232000 1.000 1.000 06003500 6 Soybean, oil 0.232000 1.000 1.000 06003501 6 Soybean, oil-babyfood 0.232000 1.000 1.000 04013550 4A Spinach 32.550000 1.000 1.000 04013551 4A Spinach-babyfood 32.550000 1.000 1.000 09023560 9B Squash, summer 0.158000 1.000 1.000 09023561 9B Squash, summer-babyfood 0.158000 1.000 1.000 09023570 9B Squash, winter 0.158000 1.000 1.000 09023571 9B Squash, winter-babyfood 0.158000 1.000 1.000 95003590 O Strawberry 0.252000 1.000 1.000 95003591 O Strawberry-babyfood 0.252000 1.000 1.000 95003600 O Strawberry, juice 0.252000 1.000 1.000 95003601 O Strawberry, juice-babyfood 0.252000 1.000 1.000 20003640 20 Sunflower, seed 0.080000 1.000 1.000 20003650 20 Sunflower, oil 0.080000 1.000 1.000 20003651 20 Sunflower, oil-babyfood 0.080000 1.000 1.000 01033660 1CD Sweet potato 0.080000 1.000 1.000 01033661 1CD Sweet potato-babyfood 0.080000 1.000 1.000 04023670 4B Swiss chard 20.160000 1.000 1.000 01033710 1CD Tanier, corm 0.080000 1.000 1.000 08003740 8 Tomatillo 0.860000 1.000 1.000
08003750 8 Tomato 0.860000 1.000 1.000 08003751 8 Tomato-babyfood 0.860000 1.000 1.000 08003760 8 Tomato, paste 2.880000 1.000 1.000 08003761 8 Tomato, paste-babyfood 2.880000 1.000 1.000 08003770 8 Tomato, puree 1.779000 1.000 1.000 08003771 8 Tomato, puree-babyfood 1.779000 1.000 1.000 08003780 8 Tomato, dried 0.860000 14.300 1.000 08003781 8 Tomato, dried-babyfood 0.860000 14.300 1.000 08003790 8 Tomato, juice 0.860000 1.500 1.000 15003810 15 Triticale, flour 0.594000 1.000 1.000 15003811 15 Triticale, flour-babyfood 0.594000 1.000 1.000 01033870 1CD Turmeric 0.080000 1.000 1.000 01013880 1AB Turnip, roots 0.180000 1.000 1.000 05023890 5B Turnip, greens 32.990000 1.000 1.000 86010000 O Water, direct, all sources 0.178000 1.000 1.000 86020000 O Water, indirect, all sources 0.178000 1.000 1.000
09013990 9A Watermelon 0.158000 1.000 1.000 09014000 9A Watermelon, juice 0.158000 1.000 1.000 15004010 15 Wheat, grain 0.594000 1.000 1.000 15004011 15 Wheat, grain-babyfood 0.594000 1.000 1.000 15004020 15 Wheat, flour 0.594000 1.000 1.000 15004021 15 Wheat, flour-babyfood 0.594000 1.000 1.000 15004030 15 Wheat, germ 0.594000 1.000 1.000 15004040 15 Wheat, bran 0.594000 1.000 1.000 01034060 1CD Yam, true 0.080000 1.000 1.000
01034070 1CD Yam bean 0.080000 1.000 1.000Fenamidone (046679) Dietary Exposure and Risk Assessment D391040

Page 14 of 15 

### Attachment 2. Fenamidone Acute Di etary Risk Assessment Results File

U.S. Environmental Protection Agency Ver. 2.02 DEEM-FCID ACUTE Analysis for FENAMIDONE (1994-98 data) Residue file: fenamidone acute and chronic f_w041311.R98 Adjustment factor #2 NOT used. Analysis Date: 04-13-2011/09:47:04 Residue file dated: 04-13-2011/09:41:07/8 NOEL (Acute) = 125.000000 mg/kg body-wt/day Daily totals for food and foodform consumption used. Run Comment: "100x uncertainty factor for acute and chronic; 1x FQPA safety f actor for acute and chronic"

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Summary calculations (per capita):

95th Percentile 99th Percentile 99.9th Percentile Exposure % aRfD MOE Exposure % aRfD MOE Exposure % aRfD MOE

---------- ------- -------- ---------- ------- -------- ---------- ------- -------- U.S. Population:
0.041808 3.34 2989 0.088483 7.08 1412 0.208933 16.71 598 All infants:
0.049304 3.94 2535 0.227071 18.17 550 0.622430 49.79 200 Children 1-2 yrs:
0.062898 5.03 1987 0.155734 12.46 802 0.488435 39.07 255 Children 3-5 yrs:
0.057048 4.56 2191 0.132124 10.57 946 0.435711 34.86 286 Children 6-12 yrs:
0.043157 3.45 2896 0.083366 6.67 1499 0.197116 15.77 634 Youth 13-19 yrs:
0.035613 2.85 3509 0.073164 5.85 1708 0.138845 11.11 900 Adults 20-49 yrs:
0.038559 3.08 3241 0.077554 6.20 1611 0.161755 12.94 772 Adults 50+ yrs:
0.041256 3.30 3029 0.094922 7.59 1316 0.176801 14.14 707 Females 13-49 yrs:
0.040734 3.26 3068 0.076527 6.12 1633 0.202195 16.18 618Fenamidone (046679) Dietary Exposure and Risk Assessment D391040

Page 15 of 15 

### Attachment 3. Fenamidone Chronic Di etary Risk Assessment Results File

U.S. Environmental Protection Agency Ver. 2.00 DEEM-FCID Chronic analysis for FENAMIDONE (1994-98 data) Residue file name: C:\Documents and Settings\ALEMAY\My Documents\Fenamidone- group 15 and 16\Dietary\DEEM files\fenamidone acute and chronic f_w041311.R98 Adjustment factor #2 NOT used. Analysis Date 04-13-2011/09:42:22 Residue file dated: 04-13-2011/09:41:07/8 Reference dose (RfD, Chronic) = .0283 mg/kg bw/day COMMENT 1: 100x uncertainty factor for acute and chronic; 1x FQPA safety factor for acute and chronic

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

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Total Exposure

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

-------------------------------------- ------------- --------------- U.S. Population (total) 0.014569 51.5%

U.S. Population (spring season) 0.014640 51.7% U.S. Population (summer season) 0.014421 51.0% U.S. Population (autumn season) 0.014606 51.6% U.S. Population (winter season) 0.014614 51.6%

Northeast region 0.014861 52.5% Midwest region 0.014102 49.8% Southern region 0.013743 48.6% Western region 0.016119 57.0%

Hispanics 0.014357 50.7% Non-hispanic whites 0.013945 49.3% Non-hispanic blacks 0.016158 57.1% Non-hisp/non-white/non-black 0.020812 73.5%

All infants (< 1 year) 0.021887 77.3% Nursing infants 0.008474 29.9% Non-nursing infants 0.026978 95.3% Children 1-6 yrs 0.023098 81.6% Children 7-12 yrs 0.014995 53.0%

Females 13-19 (not preg or nursing) 0.011140 39.4% Females 20+ (not preg or nursing) 0.014253 50.4% Females 13-50 yrs 0.013595 48.0% Females 13+ (preg/not nursing) 0.011659 41.2% Females 13+ (nursing) 0.015440 54.6%

Males 13-19 yrs 0.012373 43.7% Males 20+ yrs 0.012969 45.8% Seniors 55+ 0.014053 49.7%

Children 1-2 yrs 0.025420 89.8% Children 3-5 yrs 0.022859 80.8% Children 6-12 yrs 0.015630 55.2% Youth 13-19 yrs 0.011796 41.7% Adults 20-49 yrs 0.013340 47.1% Adults 50+ yrs 0.014109 49.9% Females 13-49 yrs 0.013388 47.3%

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