Document ID: EPA-HQ-OPP-2012-0589-0010
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2013-11-01T04:00Z

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 analyses 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), 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 95[th] 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-AUG-1999).

The most recent dietary risk assessment for fomesafen was conducted on 10/12/10 (A. LaMay, D382064).

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,α-trifluoro-p-tolyloxy) anthranilic acid and 5-(2-chloro-α,α,α-trifluoro-p-tolyloxy)-N-methylsulfonylanthranilamide.  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

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 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 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.

For a chronic dietary exposure assessment, an estimate of the residue level in each food or food-form (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
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 95[th] 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 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 95[th] 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. 
 
 
 
 X.  List of Attachments
 
Attachment 1:  DEEM-FCID(TM) Acute Residue Input File.
Attachment 2:  DEEM-FCID(TM) Acute Results File.
Attachment 3:  DEEM-FCID(TM) Chronic Residue Input File.
Attachment 4:  DEEM-FCID(TM) Chronic Results File.

Attachment 1:  DEEM-FCID(TM) 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  
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  

Attachment 2:  DEEM-FCID(TM) 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  

Attachment 3:  DEEM-FCID(TM) 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  
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  

Attachment 4:  DEEM-FCID(TM) 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%