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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C. 20460 

OFFICE OF CHEMICAL SAFETY AND

 POLLUTION PREVENTION

MEMORANDUM

Date: July 11, 2013 

SUBJECT: Fomesafen Sodium, Acute and Chronic Aggregate Dietary (Food and Drinking 

Water) Exposure and Risk Assessments for the Section 3 Registration Action on 

Cantaloupe, Cucumber, Pea (Succulent), Pumpkin, Summer Squash, Winter 

Squash, Watermelon, Soybean (Succulent) and Lima Bean (Succulent)

PC Codes: 123802, 123803 DP Barcodes: D410439, D410795 

Decision Nos.: 467057 , 477271 Registration Nos.: 100-993; 100-1017

Petition Nos.: 2E8061, 3E8167 Regulatory Action: Section 3 Registration

Risk Assessment Type: Dietary Case No.: NA

TXR No.: NA CAS No.: 72178-02-0, 108731-70-0

MRID No.: NA 40 CFR: §180.433

FROM: Danette Drew, Chemist

Risk Assessment Branch V

Health Effects Division (HED, 7509P)

THROUGH: Nancy Dodd, Chemist

Meheret Negussie, Chemist

Dietary Exposure Science Advisory Council (DESAC)

TO: Laura Nollen/Barbara Madden, RM05

Risk Integration, Minor Use & Emergency Response Branch

Registration Division (RD, 7505P)

Executive Summary

Acute and chronic aggregate dietary (food and drinking water) exposure and risk assessments 

were 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 (USDA’s) National Health and 

Nutrition Examination Survey, What We Eat in America, (NHANES/WWEIA). The analys es

were conducted in support of a human-health risk assessment for the proposed Section 3 uses of 

fomesafen sodium (commonly called fomesafen) on cantaloupe, cucumber, pea (succulent), 
Fomesafen Sodium Dietary Exposure and Risk Assessment DP Number: D410439, D410795 

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pumpkin, summer squash, winter squash, watermelon, soybean (succulent) and lima bean 

(succulent). This memorandum was reviewed by two peer reviewers of the DESAC, per DESAC 

SOP 2012.1. 

Acute and Chronic Dietary Exposure Assessment

The assumptions of these unrefined acute and chronic assessments were tolerance-level residues, 

100% crop treated, and default DEEM processing factors. Model-based estimated drinking 

water concentrations (EDWCs) from the Environmental Fate and Effects Division (EFED) were 

also included.

The dietary exposure analyses in this assessment result in dietary risk estimates for food and 

drinking water that are below the Agency’s level of concern for both acute and chronic dietary

exposures for all population subgroups. The acute exposure for food plus drinking water to the 

general U.S. population and all population subgroups was <1% of the acute population adjusted 

dose (aPAD) at the 95th percentile of exposure. The chronic exposure for food plus drinking 

water to the general U.S. population is 32% of the chronic population adjusted dose (cPAD). 

The subgroup with the highest chronic exposure and risk estimate is infants. For infants, the 

exposure for food plus drinking water was 0.001915 mg/kg/day, which represents 77% of the 

cPAD.

Cancer Dietary Exposure Assessment

The Cancer Assessment Review Committee (CARC) classified fomesafen as “Not likely to be 

carcinogenic to humans;” therefore, a cancer assessment was not performed.

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 dose that HED has concluded will result in no unreasonable adverse health effects). 

This dose is referred to as the population-adjusted dose (PAD). The PAD is equivalent to the 

point of departure (POD, NOAEL, LOAEL, e.g.) divided by the required uncertainty or safety 

factors.

For acute and non-cancer chronic exposures, HED is concerned when estimated dietary risk 

exceeds 100% of the PAD. References that discuss the acute and chronic risk 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/EPA-PEST/2000/July/Day-12/6061.pdf; or see SOP 99.6 (20-AUG1999).

The most recent dietary risk assessment for fomesafen was conducted on 10/12/10 (A. LaMay, 

D382064).
Fomesafen Sodium Dietary Exposure and Risk Assessment DP Number: D410439, D410795 

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II. Residue Information

Fomesafen sodium is a contact herbicide in the diphenylether chemical class and acts via 

inhibition of protoporphyrinogen oxidase (PPO). It is used to control broadleaf and grass weeds, 

as well as postemergence weeds in legumes and other crops.

Tolerances for fomesafen residues are listed in 40 CFR §180.433. Currently tolerances are 

established for fomesafen acid in field soybeans, dry beans, and snap (succulent) beans at 0.05 

ppm and peppers (bell and non-bell), potatoes, tomatoes, and cotton gin by-products and 

cottonseed at 0.025 ppm. In the current petitions (2E8061, 3E8167), uses are proposed for 

fomesafen on cantaloupe, cucumber, pea (succulent), pumpkin, summer squash, winter squash, 

watermelon, soybean (succulent) and lima bean (succulent). HED is recommending for tolerance 

levels of 0.025 ppm on cantaloupe, cucumber, pea (succulent), pumpkin, summer squash, winter 

squash and watermelon and 0.05 ppm on soybean (succulent) and lima bean (succulent) (I. 

Encarnacion, D407932). All crops with existing and proposed uses of fomesafen were 

considered in this assessment.

The residue of concern for plant commodities and drinking water is fomesafen. The residues of 

concern in livestock commodities consists of fomesafen and its metabolites 5-(2-chloro-α,α,αtrifluoro-p-tolyloxy) anthranilic acid and 5-(2-chloro-α,α,α-trifluoro-p-tolyloxy)-Nmethylsulfonylanthranilamide. However, based on the submitted livestock metabolism studies,

HED concluded that the proposed/registered uses of fomesafen result in a 40 CFR §180.6(a)(3) 

situation for livestock commodities; i.e., there is no reasonable expectation of finite residues in 

livestock commodities.

Tolerance-level residues and 100% crop treated were used for all commodities included in these 

assessments. Tolerance levels are based on non-detectable residues found in field trials (see 

Table 1 below). The tomato and potato processing studies previously submitted were inadequate 

due to the lack of detectable residues in/on the raw commodity. Therefore, default tomato paste, 

dried tomato, tomato juice, and tomato puree, and dried potato concentration factors were used 

for these processed commodities. 

Table 1. Tolerance Summary for Fomesafen.

Commodity Proposed Tolerance 

(ppm)

HED-Recommended 

Tolerance (ppm)

Comments 

(correct commodity definition)

Cantaloupe 0.025 0.025

Cucumber 0.025 0.025

Pea, succulent 0.025 0.025

Pumpkin 0.025 0.025

Squash, summer 0.025 0.025

Winter, Squash 0.025 0.025 Squash, winter

Watermelon 0.025 0.025

Vegetable, soybean, 

succulent 0.05 0.05 Soybean, vegetable, succulent

Lima, bean 0.05 0.05 Bean, lima, succulent
Fomesafen Sodium Dietary Exposure and Risk Assessment DP Number: D410439, D410795 

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The USDA Pesticide Data Program (PDP) monitored pesticide residues in catfish in 2008, 2009, 

and 2010. In general, pesticide residues would not be expected to be found in fish unless the 

pesticide bio accumulates or has an aquatic use. To determine whether or not residues are 

present in fish, HED now routinely checks PDP monitoring data regardless of the pesticide’s 

uses and physicochemical properties. However, PDP did not analyze catfish samples for 

fomesafen. As a result, residues in fish were not included in the assessment.

III. Percent Crop Treated Information

The acute and chronic assessments were both based on the assumption that 100% of all 

commodities with registered or proposed uses of fomesafen will be treated.

IV. Drinking Water Data

The drinking water residues used in the dietary risk assessment were provided by the EFED in 

the following memorandum: Revised Fomesafen Drinking Water Assessment to Include IR-4 Use 

on Lima Bean and Groundwater EDWCs Using a Tier-I PRZM-GW Model (D412599, H. Zhong, 

6/24/12) and incorporated directly into this dietary assessment. Water residues were 

incorporated in the DEEM-FCID into the food categories “water, direct, all sources” and “water, 

indirect, all sources.” EFED recommended the Tier I PRZM-GW highest acute value of 51.8

μg/L and chronic value of 32.3 μg/L for ground water estimated drinking water concentrations 

(EDWCs). These EDWCs were based on the highest proposed application rate for fomesafen 

(0.375 lb a.i./acre). The ground water EDWCs were higher than the surface water EDWCs,

which were based on Tier-II PRZM/EXAM modeling, and were therefore selected for use in the 

fomesafen dietary assessment.

The drinking water models and their descriptions are available at the EPA internet site:

http://www.epa.gov/oppefed1/models/water/. 

V. DEEM-FCID Program and Consumption Information

Fomesafen acute and chronic dietary exposure assessments were conducted using the DEEMFCID, 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 non-consecutive 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. However, for acute 

exposure assessment, consumption data are retained as individual consumption events. 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.
Fomesafen Sodium Dietary Exposure and Risk Assessment DP Number: D410439, D410795 

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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.

For an acute exposure assessment, individual one-day food consumption data are used on an 

individual-by-individual basis. The reported consumption amounts of each food item can be 

multiplied by a residue point estimate and summed to obtain a total daily pesticide exposure for a 

deterministic exposure assessment, or “matched” in multiple random pairings with residue values 

and then summed in a probabilistic assessment. The resulting distribution of exposures is 

expressed as a percentage of the aPAD on both a user (i.e., only those who reported eating 

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

commodities as well as those who did not) basis. In accordance with HED policy, per capita 

exposure and risk are reported for analyses performed at all levels of refinement. However, for 

deterministic assessments, any significant differences in user vs. per capita exposure and risk are 

specifically identified and noted in the risk assessment.

VI. Toxicological Information

The acute dietary endpoint is based on decreased body weight and motor activity (horizontal and 

vertical activity and time in central quadrant) in males observed in the acute neurotoxicity study

in rats. The chronic dietary endpoint is based on hyalinization of the liver in males in the chronic

toxicity/ carcinogenicity study in rat. These endpoints are applicable to all populations including 

infants and children. The FQPA safety factor is reduced to 1X as there there is no evidence of 

increased susceptibility in developing and young animals, and there are no residual uncertainties 

concerning pre- or post-natal toxicity. The toxicity and exposure databases for fomesafen are 

complete. 

In accordance with the EPA Final Guidelines for Carcinogen Risk Assessment (March 29, 2005), 

the CARC classified fomesafen as “Not Likely to be Carcinogenic to Humans.” This decision 

was based on the weight-of-evidence which supports activation of peroxisome proliferator 

activated receptor alpha (PPARα) as the mode of action for fomesafen-induced 

hepatocarcinogenesis in mice. The quantification of cancer risk is not required. 

A summary of the endpoints and points of departure selected for dietary risk assessment may be 

found in Table 2 below.

Table 2. Summary of Toxicological Doses and Endpoints for Fomesafen for Use in Dietary Human Health 

Risk Assessments

Exposure/ 

Scenario

Point of 

Departure

Uncertainty/FQPA 

Safety Factors

RfD, PAD, 

Level of 

Concern for 

Risk 

Assessment

Study and Toxicological Effects
Fomesafen Sodium Dietary Exposure and Risk Assessment DP Number: D410439, D410795 

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Table 2. Summary of Toxicological Doses and Endpoints for Fomesafen for Use in Dietary Human Health 

Risk Assessments

Exposure/ 

Scenario

Point of 

Departure

Uncertainty/FQPA 

Safety Factors

RfD, PAD, 

Level of 

Concern for 

Risk 

Assessment

Study and Toxicological Effects

Acute Dietary 

(General 

Population, 

including 

Infants and 

Children)

NOAEL = 

100 

mg/kg/day

UFA = 10x

UFH = 10x

FQPA SF = 1x

Acute RfD = 

1 mg/kg/day

aPAD = 1 

mg/kg/day

Acute neurotoxicity test in rat

LOAEL = 250 mg/kg/day based on 

decreased body weight and motor activity 

(horizontal and vertical activity and time 

in central quadrant) in males

Chronic 

Dietary (All 

Populations)

NOAEL = 

0.25 

mg/kg/day

UFA = 10x

UFH = 10x

FQPA SF = 1x

Chronic RfD 

= 0.0025 

mg/kg/day 

cPAD = 

0.0025 

mg/kg/day

Chronic toxicity/ carcinogenicity in rat 

LOAEL = 5 mg/kg/day based on 

hyalinization of the liver in males

Cancer (oral, 

dermal, 

inhalation)

Classification: The CARC classified fomesafen as “Not Likely to be Carcinogenic to Humans.”

Point of Departure (POD) = A data point or an estimated point that is derived from observed dose-response data and used to 

mark the beginning 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). UFH = potential variation in sensitivity among members of the human 

population (intraspecies). UFL = use of a LOAEL to extrapolate a NOAEL. UFS = use of a short-term study for long-term risk 

assessment. UFDB = to account for the absence of key data (i.e., lack of a critical study). FQPA SF = FQPA Safety Factor. PAD 

= population adjusted dose (a = acute, c = chronic). RfD = reference dose.

VII. Results/Discussion

As stated above, for acute and chronic assessments, HED is concerned when dietary risk exceeds 

100% of the PAD. The DEEM-FCI analysis estimates the dietary exposure of the U.S. 

population and various population subgroups. The dietary assessment results summarized in 

Table 2 are for the general U.S. Population, all infants (<1 year old), children 1-2, children 3-5, 

children 6-12, youth 13-19, females 13-49, adults 20-49, and adults 50+ years.

Results of Acute Dietary Exposure Analysis

All acute dietary (food and drinking water) risk estimates are below the level of concern for the 

general U.S. population and all population subgroups assessed. The acute exposure for food plus 

drinking water to the general U.S. population and all population subgroups was <1% of the 

aPAD at the 95th percentile of exposure.

Results of Chronic Dietary Exposure Analysis

All chronic dietary (food and drinking water) risk estimates are below the level of concern for 

the general U.S. population and all population subgroups assessed. The chronic dietary risk 

estimate for the general U.S. population is 32% of the cPAD. The population subgroup with the 
Fomesafen Sodium Dietary Exposure and Risk Assessment DP Number: D410439, D410795 

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highest exposure is all infants (<1 year old) at 0.001915 mg/kg/day, which utilized 77% of the 

cPAD. 

Table 3. Summary of Dietary (Food and Drinking Water) Exposure and Risk for Fomesafen.

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 0.002999 <1 0.000787 32

All Infants (<1 year 

old)* 0.009060 <1 0.001915 77

N/A N/A

Children 1-2 years old 0.004827 <1 0.001267 51

Children 3-5 years old 0.003915 <1 0.001085 43

Children 6-12 years old 0.002951 <1 0.000755 30

Youth 13-19 years old 0.002455 <1 0.000588 24

Adults 20-49 years old 0.002858 <1 0.000766 31

Adults 50-99 years old 0.002597 <1 0.000754 30

Females 13-49 years old 0.002938 <1 0.000760 30

*The subpopulation with the highest risk estimate

VIII. Characterization of Inputs/Outputs

HED has conducted a highly conservative, health protective assessment for the existing and 

proposed new uses of fomesafen sodium. Tolerance-level residues on foods along with 100% 

crop treated were used in the acute and chronic dietary exposure assessments. In addition, 

DEEM default processing factors were used. Drinking water estimates were based on a 

conservative modeling approach. Various refinements could be made to the assessments; 

however, as there are no risk estimates of concern, no refinements were incorporated.

IX. Conclusions

Unrefined acute and chronic dietary (food and drinking water) exposure assessments were

performed for fomesafen sodium which assumed tolerance-level residues and 100% crop treated. 

The dietary analyses for fomesafen resulted in dietary risk estimates that are below the Agency’s 

level of concern for acute and chronic dietary exposures. The acute exposure for food plus 

drinking water to the general U.S. population and all population subgroups was <1% of the 

aPAD at the 95th percentile of exposure. The chronic exposure for food plus drinking water to the 

general U.S. population is 32% of the cPAD. The subgroup with the highest chronic exposure 

and risk estimate is infants (<1 year old) at 0.001915 mg/kg/day, which represents 77% of the 

cPAD.

HED is confident that this dietary assessment does not underestimate risk to the general U.S. 

population or any population subgroup. 
Fomesafen Sodium Dietary Exposure and Risk Assessment DP Number: D410439, D410795 

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X. List of Attachments

Attachment 1: DEEM-FCIDTM Acute Residue Input File.

Attachment 2: DEEM-FCIDTM Acute Results File.

Attachment 3: DEEM-FCIDTM Chronic Residue Input File.

Attachment 4: DEEM-FCIDTM Chronic Results File.
Fomesafen Sodium Dietary Exposure and Risk Assessment DP Number: D410439, D410795 

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Attachment 1: DEEM-FCIDTM Acute Residue Input File.

Filename: C:\Documents and Settings\ddrew\My Documents\DEEM_Version_3_16\ResidueFiles\fomesafen 

acute12.r08

Chemical: Fomesafen sodium

RfD(Chronic): .0025 mg/kg bw/day NOEL(Chronic): .25 mg/kg bw/day

RfD(Acute): 1 mg/kg bw/day NOEL(Acute): 100 mg/kg bw/day

Date created/last modified: 06-20-2013/13:43:34 Program ver. 3.16, 03-08-d

Comment: with surface water EDWC

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

 EPA Crop Def Res Adj.Factors Comment

 Code Grp Commodity Name (ppm) #1 #2 

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

0103296000 1C Potato, chips 0.025000 1.000 1.000 

0103297000 1C Potato, dry (granules/ flakes) 0.025000 6.500 1.000 

0103297001 1C Potato, dry (granules/ flakes)-b 0.025000 6.500 1.000 

0103298000 1C Potato, flour 0.025000 6.500 1.000 

0103298001 1C Potato, flour-babyfood 0.025000 6.500 1.000 

0103299000 1C Potato, tuber, w/peel 0.025000 1.000 1.000 

0103299001 1C Potato, tuber, w/peel-babyfood 0.025000 1.000 1.000 

0103300000 1C Potato, tuber, w/o peel 0.025000 1.000 1.000 

0103300001 1C Potato, tuber, w/o peel-babyfood 0.025000 1.000 1.000 

0600347000 6 Soybean, seed 0.050000 1.000 1.000 

0600349000 6 Soybean, soy milk 0.050000 1.000 1.000 

0600349001 6 Soybean, soy milk-babyfood or in 0.050000 1.000 1.000 

0600350000 6 Soybean, oil 0.050000 1.000 1.000 

0600350001 6 Soybean, oil-babyfood 0.050000 1.000 1.000 

0601043000 6A Bean, snap, succulent 0.050000 1.000 1.000 

0601043001 6A Bean, snap, succulent-babyfood 0.050000 1.000 1.000 

0601349500 6AB Soybean, vegetable 0.050000 1.000 1.000 

0602037000 6B Bean, lima, succulent 0.050000 1.000 1.000 

0602255000 6B Pea, succulent 0.025000 1.000 1.000 

0602255001 6B Pea, succulent-babyfood 0.025000 1.000 1.000 

0603030000 6C Bean, black, seed 0.050000 1.000 1.000 

0603032000 6C Bean, broad, seed 0.050000 1.000 1.000 

0603034000 6C Bean, cowpea, seed 0.050000 1.000 1.000 

0603035000 6C Bean, great northern, seed 0.050000 1.000 1.000 

0603036000 6C Bean, kidney, seed 0.050000 1.000 1.000 

0603038000 6C Bean, lima, seed 0.050000 1.000 1.000 

0603039000 6C Bean, mung, seed 0.050000 1.000 1.000 

0603040000 6C Bean, navy, seed 0.050000 1.000 1.000 

0603041000 6C Bean, pink, seed 0.050000 1.000 1.000 

0603042000 6C Bean, pinto, seed 0.050000 1.000 1.000 

0603098000 6C Chickpea, seed 0.050000 1.000 1.000 

0603098001 6C Chickpea, seed-babyfood 0.050000 1.000 1.000 

0603099000 6C Chickpea, flour 0.050000 1.000 1.000 

0603182000 6C Guar, seed 0.050000 1.000 1.000 

0603182001 6C Guar, seed-babyfood 0.050000 1.000 1.000 

0603203000 6C Lentil, seed 0.050000 1.000 1.000 

0603256000 6C Pea, dry 0.050000 1.000 1.000 

0603256001 6C Pea, dry-babyfood 0.050000 1.000 1.000 

0603258000 6C Pea, pigeon, seed 0.050000 1.000 1.000 

0603348000 6C Soybean, flour 0.050000 1.000 1.000 

0603348001 6C Soybean, flour-babyfood 0.050000 1.000 1.000 

0801374000 8A Tomatillo 0.025000 1.000 1.000 

0801375000 8A Tomato 0.025000 1.000 1.000 

0801375001 8A Tomato-babyfood 0.025000 1.000 1.000 

0801376000 8A Tomato, paste 0.025000 5.400 1.000 

0801376001 8A Tomato, paste-babyfood 0.025000 5.400 1.000 

0801377000 8A Tomato, puree 0.025000 3.300 1.000 

0801377001 8A Tomato, puree-babyfood 0.025000 3.300 1.000 

0801378000 8A Tomato, dried 0.025000 14.300 1.000 

0801378001 8A Tomato, dried-babyfood 0.025000 14.300 1.000 

0801379000 8A Tomato, juice 0.025000 1.500 1.000 

0801380000 8A Tomato, Tree 0.025000 1.000 1.000 

0802270000 8B Pepper, bell 0.025000 1.000 1.000 

0802270001 8B Pepper, bell-babyfood 0.025000 1.000 1.000 

0802271000 8B Pepper, bell, dried 0.025000 1.000 1.000 
Fomesafen Sodium Dietary Exposure and Risk Assessment DP Number: D410439, D410795 

Page 10 of 14

0802271001 8B Pepper, bell, dried-babyfood 0.025000 1.000 1.000 

0802272000 8BC Pepper, nonbell 0.025000 1.000 1.000 

0802272001 8BC Pepper, nonbell-babyfood 0.025000 1.000 1.000 

0802273000 8BC Pepper, nonbell, dried 0.025000 1.000 1.000 

0901075000 9A Cantaloupe 0.025000 1.000 1.000 

0901399000 9A Watermelon 0.025000 1.000 1.000 

0901400000 9A Watermelon, juice 0.025000 1.000 1.000 

0902135000 9B Cucumber 0.025000 1.000 1.000 

0902308000 9B Pumpkin 0.025000 1.000 1.000 

0902309000 9B Pumpkin, seed 0.025000 1.000 1.000 

0902356000 9B Squash, summer 0.025000 1.000 1.000 

0902356001 9B Squash, summer-babyfood 0.025000 1.000 1.000 

0902357000 9B Squash, winter 0.025000 1.000 1.000 

0902357001 9B Squash, winter-babyfood 0.025000 1.000 1.000 

2003128000 20C Cottonseed, oil 0.025000 1.000 1.000 

2003128001 20C Cottonseed, oil-babyfood 0.025000 1.000 1.000 

8601000000 86A Water, direct, all sources 0.051800 1.000 1.000 

8602000000 86B Water, indirect, all sources 0.051800 1.000 1.000 
Fomesafen Sodium Dietary Exposure and Risk Assessment DP Number: D410439, D410795 

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Attachment 2: DEEM-FCIDTM Acute Results File.

U.S. EPA Ver. 3.16, 03-08-d

DEEM-FCID ACUTE Analysis for FOMESAFEN SODIUM NHANES 2003-2008 2-Day

Residue file: fomesafen acute12.r08 Adjustment factor #2 NOT used.

Analysis Date: 06-20-2013/13:46:35 Residue file dated: 06-20-2013/13:43:34

NOEL (Acute) = 100.000000 mg/kg body-wt/day

RAC/FF intake summed over 24 hours

Run Comment: "with surface water EDWC"

===============================================================================

Summary calculations--per capita:

--- 95th Percentile---- --- 99th Percentile---- ---99.9th Percentile----

Exposure % aRfD MOE Exposure % aRfD MOE Exposure % aRfD MOE 

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

Total US Population:

 0.002999 0.30 33349 0.004871 0.49 20531 0.009056 0.91 11042 

All Infants:

 0.009060 0.91 11037 0.012121 1.21 8250 0.017781 1.78 5623 

Children 1-2:

 0.004827 0.48 20715 0.007006 0.70 14272 0.016315 1.63 6129 

Children 3-5:

 0.003915 0.39 25539 0.005715 0.57 17498 0.009036 0.90 11067 

Children 6-12:

 0.002951 0.30 33891 0.004553 0.46 21962 0.006963 0.70 14361 

Youth 13-19:

 0.002455 0.25 40733 0.004031 0.40 24807 0.006020 0.60 16610 

Adults 20-49:

 0.002858 0.29 34984 0.004247 0.42 23544 0.006065 0.61 16487 

Adults 50-99:

 0.002597 0.26 38503 0.003921 0.39 25502 0.006049 0.60 16531 

Female 13-49:

 0.002938 0.29 34035 0.004253 0.43 23513 0.005965 0.60 16765 
Fomesafen Sodium Dietary Exposure and Risk Assessment DP Number: D410439, D410795 

Page 12 of 14

Attachment 3: DEEM-FCIDTM Chronic Residue Input File.

Filename: C:\Documents and Settings\ddrew\My Documents\DEEM_Version_3_16\ResidueFiles\fomesafen 

chronic12.r08

Chemical: Fomesafen sodium

RfD(Chronic): .0025 mg/kg bw/day NOEL(Chronic): .25 mg/kg bw/day

RfD(Acute): 1 mg/kg bw/day NOEL(Acute): 100 mg/kg bw/day

Date created/last modified: 06-20-2013/13:36:32 Program ver. 3.16, 03-08-d

Comment: with surface water EDWC

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

 EPA Crop Def Res Adj.Factors Comment

 Code Grp Commodity Name (ppm) #1 #2 

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

0103296000 1C Potato, chips 0.025000 1.000 1.000 

0103297000 1C Potato, dry (granules/ flakes) 0.025000 6.500 1.000 

0103297001 1C Potato, dry (granules/ flakes)-b 0.025000 6.500 1.000 

0103298000 1C Potato, flour 0.025000 6.500 1.000 

0103298001 1C Potato, flour-babyfood 0.025000 6.500 1.000 

0103299000 1C Potato, tuber, w/peel 0.025000 1.000 1.000 

0103299001 1C Potato, tuber, w/peel-babyfood 0.025000 1.000 1.000 

0103300000 1C Potato, tuber, w/o peel 0.025000 1.000 1.000 

0103300001 1C Potato, tuber, w/o peel-babyfood 0.025000 1.000 1.000 

0600347000 6 Soybean, seed 0.050000 1.000 1.000 

0600349000 6 Soybean, soy milk 0.050000 1.000 1.000 

0600349001 6 Soybean, soy milk-babyfood or in 0.050000 1.000 1.000 

0600350000 6 Soybean, oil 0.050000 1.000 1.000 

0600350001 6 Soybean, oil-babyfood 0.050000 1.000 1.000 

0601043000 6A Bean, snap, succulent 0.050000 1.000 1.000 

0601043001 6A Bean, snap, succulent-babyfood 0.050000 1.000 1.000 

0601349500 6AB Soybean, vegetable 0.050000 1.000 1.000 

0602037000 6B Bean, lima, succulent 0.050000 1.000 1.000 

0602255000 6B Pea, succulent 0.025000 1.000 1.000 

0602255001 6B Pea, succulent-babyfood 0.025000 1.000 1.000 

0603030000 6C Bean, black, seed 0.050000 1.000 1.000 

0603032000 6C Bean, broad, seed 0.050000 1.000 1.000 

0603034000 6C Bean, cowpea, seed 0.050000 1.000 1.000 

0603035000 6C Bean, great northern, seed 0.050000 1.000 1.000 

0603036000 6C Bean, kidney, seed 0.050000 1.000 1.000 

0603038000 6C Bean, lima, seed 0.050000 1.000 1.000 

0603039000 6C Bean, mung, seed 0.050000 1.000 1.000 

0603040000 6C Bean, navy, seed 0.050000 1.000 1.000 

0603041000 6C Bean, pink, seed 0.050000 1.000 1.000 

0603042000 6C Bean, pinto, seed 0.050000 1.000 1.000 

0603098000 6C Chickpea, seed 0.050000 1.000 1.000 

0603098001 6C Chickpea, seed-babyfood 0.050000 1.000 1.000 

0603099000 6C Chickpea, flour 0.050000 1.000 1.000 

0603182000 6C Guar, seed 0.050000 1.000 1.000 

0603182001 6C Guar, seed-babyfood 0.050000 1.000 1.000 

0603203000 6C Lentil, seed 0.050000 1.000 1.000 

0603256000 6C Pea, dry 0.050000 1.000 1.000 

0603256001 6C Pea, dry-babyfood 0.050000 1.000 1.000 

0603258000 6C Pea, pigeon, seed 0.050000 1.000 1.000 

0603348000 6C Soybean, flour 0.050000 1.000 1.000 

0603348001 6C Soybean, flour-babyfood 0.050000 1.000 1.000 

0801374000 8A Tomatillo 0.025000 1.000 1.000 

0801375000 8A Tomato 0.025000 1.000 1.000 

0801375001 8A Tomato-babyfood 0.025000 1.000 1.000 

0801376000 8A Tomato, paste 0.025000 5.400 1.000 

0801376001 8A Tomato, paste-babyfood 0.025000 5.400 1.000 

0801377000 8A Tomato, puree 0.025000 3.300 1.000 

0801377001 8A Tomato, puree-babyfood 0.025000 3.300 1.000 

0801378000 8A Tomato, dried 0.025000 14.300 1.000 

0801378001 8A Tomato, dried-babyfood 0.025000 14.300 1.000 

0801379000 8A Tomato, juice 0.025000 1.500 1.000 

0801380000 8A Tomato, Tree 0.025000 1.000 1.000 

0802270000 8B Pepper, bell 0.025000 1.000 1.000 

0802270001 8B Pepper, bell-babyfood 0.025000 1.000 1.000 

0802271000 8B Pepper, bell, dried 0.025000 1.000 1.000 
Fomesafen Sodium Dietary Exposure and Risk Assessment DP Number: D410439, D410795 

Page 13 of 14

0802271001 8B Pepper, bell, dried-babyfood 0.025000 1.000 1.000 

0802272000 8BC Pepper, nonbell 0.025000 1.000 1.000 

0802272001 8BC Pepper, nonbell-babyfood 0.025000 1.000 1.000 

0802273000 8BC Pepper, nonbell, dried 0.025000 1.000 1.000 

0901075000 9A Cantaloupe 0.025000 1.000 1.000 

0901399000 9A Watermelon 0.025000 1.000 1.000 

0901400000 9A Watermelon, juice 0.025000 1.000 1.000 

0902135000 9B Cucumber 0.025000 1.000 1.000 

0902308000 9B Pumpkin 0.025000 1.000 1.000 

0902309000 9B Pumpkin, seed 0.025000 1.000 1.000 

0902356000 9B Squash, summer 0.025000 1.000 1.000 

0902356001 9B Squash, summer-babyfood 0.025000 1.000 1.000 

0902357000 9B Squash, winter 0.025000 1.000 1.000 

0902357001 9B Squash, winter-babyfood 0.025000 1.000 1.000 

2003128000 20C Cottonseed, oil 0.025000 1.000 1.000 

2003128001 20C Cottonseed, oil-babyfood 0.025000 1.000 1.000 

8601000000 86A Water, direct, all sources 0.032300 1.000 1.000 

8602000000 86B Water, indirect, all sources 0.032300 1.000 1.000 
Fomesafen Sodium Dietary Exposure and Risk Assessment DP Number: D410439, D410795 

Page 14 of 14

Attachment 4: DEEM-FCIDTM Chronic Results File.

U.S. EPA Ver. 3.16, 03-08-d

DEEM-FCID Chronic analysis for FOMESAFEN SODIUM NHANES 2003-2008 2-day

Residue file name: C:\Documents and Settings\ddrew\My 

Documents\DEEM_Version_3_16\ResidueFiles\fomesafen chronic12.r08

 Adjustment factor #2 NOT used.

Analysis Date 06-20-2013/13:37:46 Residue file dated: 06-20-2013/13:36:32

Reference dose (RfD, Chronic) = .0025 mg/kg bw/day

COMMENT 1: with surface water EDWC

===============================================================================

 Total exposure by population subgroup

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

 Total Exposure

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

 Population mg/kg Percent of 

 Subgroup body wt/day Rfd 

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

Total US Population 0.000787 31.5%

Hispanic 0.000768 30.7%

Non-Hisp-White 0.000805 32.2%

Non-Hisp-Black 0.000659 26.4%

Non-Hisp-Other 0.000902 36.1%

Nursing Infants 0.000702 28.1%

Non-Nursing Infants 0.002457 98.3%

Female 13+ PREG 0.000744 29.7%

Children 1-6 0.001133 45.3%

Children 7-12 0.000715 28.6%

Male 13-19 0.000565 22.6%

Female 13-19/NP 0.000611 24.4%

Male 20+ 0.000722 28.9%

Female 20+/NP 0.000797 31.9%

Seniors 55+ 0.000740 29.6%

All Infants 0.001915 76.6%

Female 13-50 0.000760 30.4%

Children 1-2 0.001267 50.7%

Children 3-5 0.001085 43.4%

Children 6-12 0.000755 30.2%

Youth 13-19 0.000588 23.5%

Adults 20-49 0.000766 30.6%

Adults 50-99 0.000754 30.1%

Female 13-49 0.000760 30.4%