Document ID: EPA-HQ-OPP-2007-0097-0003
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2007-06-06T04:00Z

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

  SEQ CHAPTER \h \r 1 WASHINGTON, D.C.  20460

		

							            OFFICE OF

							PREVENTION, PESTICIDES

							AND TOXIC SUBSTANCES 

February 15, 2006

  SEQ CHAPTER \h \r 1 MEMORANDUM

SUBJECT:	  SEQ CHAPTER \h \r 1 Fomesafen Sodium: Chronic Dietary
Exposure Assessment for the HED Human Health Risk Assessment.

		

		  SEQ CHAPTER \h \r 1 PC Code:	123802		

DP Number:	D325798				

	

FROM:	Toiya Goodlow, Chemist			

		Reregistration Branch 1

		Health Effects Division (7509C)

THROUGH:	Tom Bloem  SEQ CHAPTER \h \r 1 , Chemist

Leung Cheng, Chemist

Dietary Exposure Science Advisory Council (DESAC)

		Health Effects Division (7509C)

	

			and	

		

		Whang Phang, Ph.D., Branch Senior Scientist

		Reregistration Branch 1

		Health Effects Division (7509C)

TO:		  SEQ CHAPTER \h \r 1 Donna Davis, Chemist

		Reregistration Branch 1

Health Effects Division (7509C)

  SEQ CHAPTER \h \r 1 Executive Summary

Chronic dietary risk assessments were conducted using the Dietary
Exposure Evaluation Model (DEEM-FCID™), Version 2.03, which used food
consumption data from the United States Department of Agriculture’s
(USDA’s) Continuing Surveys of Food Intakes by Individuals (CSFII)
from 1994-1996 and 1998.  The analyses were performed to support the HED
Human Health Risk Assessment for fomesafen sodium (commonly called
fomesafen).

   

No acute dietary toxicity endpoint could be identified based on the
toxicology data currently available for fomesafen sodium.  The Cancer
Assessment Review Committee (CARC) classified fomesafen as “Not likely
to be carcinogenic to humans”; therefore, a cancer assessment was not
performed.

  SEQ CHAPTER \h \r 1 Chronic Dietary Exposure Results and
Characterization

Chronic dietary exposure assessments were performed for fomesafen
sodium.  The assumptions of these assessments were tolerance level
residues and 100% crop treated.  Estimated drinking water concentrations
(EDWCs) from the Environmental Fate and Effects Division were also
included.  The dietary exposure analyses in this assessment result in
dietary risk estimates for food and water that are below the Agency’s
level of concern for chronic dietary exposure.  The highest exposure and
risk estimates were for the ‘all infants’ population subgroup.  The
exposure for food plus surface water was 0.000766 mg/kg/day, which
utilized 31% of the chronic population adjusted dose (cPAD); and the
exposure for food plus ground water was 0.000107 mg/kg/day, which
utilized 4.3% of the cPAD.

  SEQ CHAPTER \h \r 1 I.	Introduction

The 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
which 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 reference dose (RfD) divided by the
special Food Quality Protection Act (FQPA) Safety Factor.

For non-cancer chronic exposures, HED is concerned when estimated
dietary risk exceeds 100% of the PAD.  References which discuss the
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,” 6/21/2000, web link:     
HYPERLINK
"http://www.epa.gov/fedrgstr/EPA-PEST/2000/July/Day-12/6061.pdf" 
http://www.epa.gov/fedrgstr/EPA-PEST/2000/July/Day-12/6061.pdf ; or see
SOP 99.6 (8/20/99).

  SEQ CHAPTER \h \r 1 This action represents the first dietary exposure
assessment for the fomesafen HED human health risk assessment.

  SEQ CHAPTER \h \r 1 II.	Residue Information

  SEQ CHAPTER \h \r 1 Fomesafen sodium is a contact herbicide in the
diphenylether chemical class.  The herbicide acts via inhibition of
protoporphyrinogen oxidase (PPO), and is therefore a Group 14 herbicide.
 It is used to control broadleaf and grass weeds, as well as
postemergence weeds in soybeans and other legumes.

Fomesafen Sodium Use:

  SEQ CHAPTER \h \r 1 Tolerances for fomesafen residues are listed in 40
CFR §180.433.  Currently, the single established tolerance is expressed
in terms of “sodium salt of fomesafen,
5-[2-chloro-4-(trifluoromethyl)phenoxy]-N-(methylsulfonyl)-2-nitrobenzam
ide” for residues in/on soybean at 0.05 ppm.  The registrant,   SEQ
CHAPTER \h \r 1 Syngenta, has proposed to reduce the soybean tolerance
to 0.02 ppm, in addition to the establishment of tolerances for
fomesafen residues in/on cottonseed and cotton gin byproducts, both at
0.025 ppm.  Additionally,   SEQ CHAPTER \h \r 1 the Interregional
Research Project No. 4 (IR-4) has proposed the establishment of
tolerances for the fomesafen residues in/on snap beans and dry beans at
0.025 ppm.  HED has approved the tolerance reduction for soybeans, new
uses for cotton and the IR-4 uses on snap and dry beans. 

The residue of concern for plant commodities and water is fomesafen per
se.    SEQ CHAPTER \h \r 1 The residue of concern in livestock
commodities consists of fomesafen and its metabolites
5-(2-chloro-α,α,α-trifluoro-p-tolyloxy) anthranilic acid (compound V)
and
5-(2-chloro-α,α,α-trifluoro-p-tolyloxy)-N-methylsulfonylanthranilamid
e (compound XV).  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.

  SEQ CHAPTER \h \r 1 Residue Data Used for Chronic Assessments:

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

  SEQ CHAPTER \h \r 1 Estimated drinking water concentrations for the
chronic assessments were estimated using two Environmental Fate and
Effects Division screening models: PRZM-EXAMS and SCI-GROW, Version 2.3.
 Syngenta submitted a prospective ground water monitoring study for
fomesafen use on soybeans.  EFED recommended using the ground water
monitoring concentration of 1 ppb, since it represents actual use
conditions of fomesafen on soybeans on a vulnerable soil.  Chronic EDWCs
for surface and ground water sources were used in these assessments, see
Tables I and II below.

  SEQ CHAPTER \h \r 1 Table I.  Surface Water EDWCs for Fomesafen Sodium
Using PRZM-EXAMS

Crop	Peak	90 Day Average	Annual Average	30 Year Average

	ppb (μg/L)

Soybeans	15.489	12.177	6.574	3.364

Cotton	25.167	19.178	10.535   SEQ CHAPTER \h \r 1 1	5.609

Cotton	20.488	15.312	9.735	5.443

Cotton	25.372	18.612	8.615	3.873

  SEQ CHAPTER \h \r 1 1 Represents value used in dietary assessment

Table II.  Ground Water EDWCs for Fomesafen Sodium

Monitoring 	Modeling (SCI-GROW) 

ppb (μg/L)

1.01	11.2

1 Represents value used in dietary assessment

  SEQ CHAPTER \h \r 1 III  Program and Consumption Information

Several reasonable peer-reviewed softwares have recently been emerging
for modeling dietary exposure to pesticides.  For a variety of
technical, historical, and availability reasons, DEEMTM was the program
generally used by EPA’s Office of Pesticide Programs (OPP) for
conducting its dietary risk assessments.  With the advent and current
availability of a number of other exposure software programs, OPP,
registrants, and other interested parties have available to them the
option of selecting other peer-reviewed exposure software in conducting
risk assessments for pesticides.  Dietary exposure assessments may also
be performed with other, similar programs, and if submitted, such
results will be reviewed by EPA for acceptability and comparability to
existing peer-reviewed software being used by OPP.  

FCID™ Program and Consumption Information

Fomesafen sodium chronic dietary exposure assessments were conducted
using the Dietary Exposure Evaluation Model software with the Food
Commodity Intake Database (DEEM-FCID™, Version 2.03), which
incorporates consumption data from USDA’s Continuing Surveys of Food
Intakes by Individuals (CSFII), 1994-1996 and 1998.  The 1994-96, 98
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, but for acute exposure
assessment are retained as individual consumption events.  Based on
analysis of the 1994-96, 98 CSFII 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+ years old.

For 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.

  SEQ CHAPTER \h \r 1 IV.	Toxicological Information

  SEQ CHAPTER \h \r 1 Table III.  Summary of Toxicological Dose and
Endpoints for Dietary Exposure Assessment of Fomesafen Sodium

  SEQ CHAPTER \h \r 1 Exposure	Dose and Uncertainty Factors	Special FQPA
Safety Factor	Study and Toxicological Effects

  SEQ CHAPTER \h \r 1 Acute Dietary                       (any
population)	No appropriate study is available for determination of this
endpoint.

Chronic Dietary                     (all populations)	  SEQ CHAPTER \h
\r 1 NOAEL = 0.25 mg/kg/day

UF = 100

Chronic RfD  = 0.0025 mg/kg/day	FQPA  SF  = 1X

(cPAD) = 0.0025

mg/kg/day	Chronic toxicity - rat

LOAEL = 5 mg/kg/day based on hyalinization of the liver in males

Cancer	  SEQ CHAPTER \h \r 1 Classification: The CARC classified
Fomesafen as “Not Likely to be Carcinogenic to Humans.”

  SEQ CHAPTER \h \r 1 V.	Results/Discussion

As stated above, for chronic assessments, HED is concerned when dietary
risk exceeds 100% of the PAD.  The DEEM-FCID™ analysis estimates the
dietary exposure of the U.S. population and various population
subgroups.  The results summarized in Table IV 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.

  SEQ CHAPTER \h \r 1 Results of Chronic Dietary Exposure Analysis

The chronic assessments estimate the dietary exposure of 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+
years old.  The highest exposure and risk estimates were for all infants
population subgroup.  The exposure for food plus surface water was
0.000766 mg/kg/day, which utilized 31% of the cPAD; and the exposure for
food plus ground water was 0.000107mg/kg/day, which utilizes 4.3% of the
cPAD.  The results of the chronic dietary analyses for both drinking
water sources are reported in Table IV below.

  SEQ CHAPTER \h \r 1 Table IV.  Summary of Chronic Dietary Exposure and
Risk for Fomesafen Sodium                                               
                            Incorporating Surface and Ground Water As
Drinking Water Sources

Population Subgroup 1	Surface Water	Ground Water

	EDWC (ppb)	 Exposure (mg/kg/day)	% cPAD 	EDWC (ppb)	 Exposure

(mg/kg/day)	% cPAD  

General U.S. Population	10.535	0.000239	9.5	1.0	0.000038	1.5

All Infants (< 1 year old) 	10.535	0.000766	31	1.0	0.000107	4.3

Children 1-2 years old	10.535	0.000371	15	1.0	0.000072	2.9

Children 3-5 years old	10.535	0.000344	14	1.0	0.000064	2.6

Children 6-12 years old	10.535	0.000236	9.4	1.0	0.000044	1.7

Youth 13-19 years old	10.535	0.000175	7.0	1.0	0.000030	1.2

Adults 20-49 years old	10.535	0.000221	8.8	1.0	0.000033	1.3

Adults 50+ years old	10.535	0.000231	9.2	1.0	0.000033	1.3

Females 13-49 years old	10.535	0.000219	8.8	1.0	0.000032	1.3

  SEQ CHAPTER \h \r 1   1 The values for the population with the highest
exposure for each type of risk assessment are bolded.

  SEQ CHAPTER \h \r 1 VI.	Conclusions

A Tier I dietary exposure assessment was performed for fomesafen sodium.
 The assumptions of these dietary exposure assessments were tolerance
level residues and 100% crop treated.  The dietary-exposure analyses in
this assessment for fomesafen result in dietary risk for food and water
estimates that are below the Agency’s level of concern for chronic
dietary exposure.  The highest exposure and risk estimates were for all
infants.  Thirty-one percent of the cPAD was utilized using surface
water as the drinking water source, and approximately four percent of
the cPAD was utilized for ground water. 

As stated above, for chronic dietary exposure assessments, HED is
concerned when dietary risk exceeds 100% of the PAD.    SEQ CHAPTER \h
\r 1 Food and water exposures from both drinking water sources show that
the chronic exposure is <31% of the cPAD for fomesafen. 

  SEQ CHAPTER \h \r 1 VII. References

Rossenbalt, Daniel. DP Barcodes: D314014, D354673, D318123. September
27, 2005. Tier II Drinking Water Assessment for Fomesafen Use on Cotton,
Soybeans, Dry Beans, and Snap Beans.

  SEQ CHAPTER \h \r 1 VIII.	List of Attachments

Attachment 1:  DEEM-FCID™ Chronic Food plus Surface Water Residue
Input file.

Attachment 2:  DEEM-FCID™ Chronic Food plus Surface Water Results
file.

Attachment 3:  DEEM-FCID™ Chronic Food plus Ground Water Residue Input
file.

Attachment 4:  DEEM-FCID™ Chronic Food plus Ground Water Results file.

  SEQ CHAPTER \h \r 1 cc:	T.Goodlow/HED/RRB1.Attachment 1: 
DEEM-FCID™ Chronic Food plus Surface Water Residue Input 

	file.

U.S. Environmental Protection Agency                                
Ver. 2.00

DEEM-FCID Chronic analysis for FOMESAFEN SODIUM                  
1994-98 data

Residue file: C:\2004DEEMFCID\Fomesafen\FomesafenDietary
Assessment\Fomesafen_chronic_surfaceH2O.R98

                                                           Adjust. #2
NOT used

Analysis Date 01-26-2006             Residue file dated:
01-25-2006/16:02:54/8

Reference dose (RfD) = 0.0025  (NOEL) = 0.25 mg/kg bw/day

Comment:FQPA SF of 1X

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

Food Crop                                       Residue      
Adj.Factors      Comment

EPA Code  Grp  Food Name                          (ppm)       

                                                             #1        
#2 

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

06030300 6C   Bean, black, seed                  0.025000   1.000     
1.000   

06030320 6C   Bean, broad, seed                  0.025000   1.000     
1.000   

06030340 6C   Bean, cowpea, seed                 0.025000   1.000     
1.000   

06030350 6C   Bean,  great northern, seed        0.025000   1.000     
1.000   

06030360 6C   Bean, kidney, seed                 0.025000   1.000     
1.000   

06030380 6C   Bean, lima, seed                   0.025000   1.000     
1.000   

06030390 6C   Bean, mung, seed                   0.025000   1.000     
1.000   

06030400 6C   Bean, navy, seed                   0.025000   1.000     
1.000   

06030410 6C   Bean, pink, seed                   0.025000   1.000     
1.000   

06030420 6C   Bean, pinto, seed                  0.025000   1.000     
1.000   

06010430 6A   Bean, snap, succulent              0.025000   1.000     
1.000   

06010431 6A   Bean, snap, succulent-babyfood     0.025000   1.000     
1.000   

06030980 6C   Chickpea, seed                     0.025000   1.000     
1.000   

06030981 6C   Chickpea, seed-babyfood            0.025000   1.000     
1.000   

06030990 6C   Chickpea, flour                    0.025000   1.000     
1.000   

95001280 O    Cottonseed, oil                    0.025000   1.000     
1.000   

95001281 O    Cottonseed, oil-babyfood           0.025000   1.000     
1.000   

06031820 6C   Guar, seed                         0.025000   1.000     
1.000   

06031821 6C   Guar, seed-babyfood                0.025000   1.000     
1.000   

06032030 6C   Lentil, seed                       0.025000   1.000     
1.000   

06032560 6C   Pea, dry                           0.025000   1.000     
1.000   

06032561 6C   Pea, dry-babyfood                  0.025000   1.000     
1.000   

06032580 6C   Pea, pigeon, seed                  0.025000   1.000     
1.000   

06003470 6    Soybean, seed                      0.020000   1.000     
1.000   

06003480 6    Soybean, flour                     0.020000   1.000     
1.000   

06003481 6    Soybean, flour-babyfood            0.020000   1.000     
1.000   

06003490 6    Soybean, soy milk                  0.020000   1.000     
1.000   

06003491 6    Soybean, soy milk-babyfood or in   0.020000   1.000     
1.000   

06003500 6    Soybean, oil                       0.020000   1.000     
1.000   

06003501 6    Soybean, oil-babyfood              0.020000   1.000     
1.000   

86010000 O    Water, direct, all sources         0.010535   1.000     
1.000   

86020000 O    Water, indirect, all sources       0.010535   1.000     
1.000   

Attachment 2:  DEEM-FCID™ Chronic Food plus Surface Water Results
file.  

U.S. Environmental Protection Agency                                
Ver. 2.00

DEEM-FCID Chronic analysis for FOMESAFEN SODIUM                 (1994-98
data)

Residue file name: C:\2004DEEMFCID\Fomesafen\FomesafenDietary
Assessment\Fomesafen_chronic_surfaceH2O.R98

                                                 Adjustment factor #2
NOT used.

Analysis Date 01-26-2006/08:45:28     Residue file dated:
01-25-2006/16:02:54/8

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

NOEL (Chronic) = .25 mg/kg bw/day

COMMENT 1: FQPA SF of 1X; surface water

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

                    Total exposure by population subgroup

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

                                                    Total Exposure

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

          Population                         mg/kg       Margin of  
Percent 

           Subgroup                       body wt/day   Exposure 1/  of
RfD 

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

U.S. Population (total)                     0.000239        1,048       
9.5%

U.S. Population (spring season)             0.000236        1,058       
9.4%

U.S. Population (summer season)             0.000255          981      
10.2%

U.S. Population (autumn season)             0.000232        1,079       
9.3%

U.S. Population (winter season)             0.000231        1,080       
9.3%

Northeast region                            0.000217        1,152       
8.7%

Midwest region                              0.000241        1,037       
9.6%

Southern region                             0.000229        1,094       
9.1%

Western region                              0.000271          921      
10.9%

Hispanics                                   0.000272          920      
10.9%

Non-hispanic whites                         0.000232        1,076       
9.3%

Non-hispanic blacks                         0.000229        1,093       
9.1%

Non-hisp/non-white/non-black                0.000293          852      
11.7%

All infants (< 1 year)                      0.000766          326      
30.6%

Nursing infants                             0.000287          870      
11.5%

Non-nursing infants                         0.000948          264      
37.9%

Children 1-6  yrs                           0.000346          722      
13.9%

Children 7-12 yrs                           0.000224        1,117       
9.0%

Females 13-19 (not preg or nursing)         0.000169        1,476       
6.8%

Females 20+ (not preg or nursing)           0.000234        1,069       
9.4%

Females 13-50 yrs                           0.000229        1,092       
9.2%

Females 13+ (preg/not nursing)              0.000230        1,087       
9.2%

Females 13+ (nursing)                       0.000325          770      
13.0%

Males 13-19 yrs                             0.000179        1,394       
7.2%

Males 20+ yrs                               0.000213        1,174       
8.5%

Seniors 55+                                 0.000230        1,085       
9.2%

Children 1-2 yrs                            0.000371          674      
14.8%

Children 3-5 yrs                            0.000344          727      
13.7%

Children 6-12 yrs                           0.000236        1,058       
9.4%

Youth 13-19 yrs                             0.000175        1,428       
7.0%

Adults 20-49 yrs                            0.000221        1,132       
8.8%

Adults 50+ yrs                              0.000231        1,084       
9.2%

Females 13-49 yrs                           0.000219        1,141       
8.8%

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

Attachment 3:  DEEM-FCID™ Chronic Food plus Ground Water Residue Input

	file.

U.S. Environmental Protection Agency                                
Ver. 2.00

DEEM-FCID Chronic analysis for FOMESAFEN SODIUM                  
1994-98 data

Residue file: C:\2004DEEMFCID\Fomesafen\FomesafenDietary
Assessment\Fomesafen_chronic_groundH2O.R98

                                                           Adjust. #2
NOT used

Analysis Date 01-26-2006             Residue file dated:
01-25-2006/15:58:50/8

Reference dose (RfD) = 0.0025  (NOEL) = 0.25 mg/kg bw/day

Comment:FQPA SF of 1X

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

Food Crop                                       Residue      
Adj.Factors      Comment

EPA Code  Grp  Food Name                          (ppm)       

                                                             #1        
#2 

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

06030300 6C   Bean, black, seed                  0.025000   1.000     
1.000   

06030320 6C   Bean, broad, seed                  0.025000   1.000     
1.000   

06030340 6C   Bean, cowpea, seed                 0.025000   1.000     
1.000   

06030350 6C   Bean,  great northern, seed        0.025000   1.000     
1.000   

06030360 6C   Bean, kidney, seed                 0.025000   1.000     
1.000   

06030380 6C   Bean, lima, seed                   0.025000   1.000     
1.000   

06030390 6C   Bean, mung, seed                   0.025000   1.000     
1.000   

06030400 6C   Bean, navy, seed                   0.025000   1.000     
1.000   

06030410 6C   Bean, pink, seed                   0.025000   1.000     
1.000   

06030420 6C   Bean, pinto, seed                  0.025000   1.000     
1.000   

06010430 6A   Bean, snap, succulent              0.025000   1.000     
1.000   

06010431 6A   Bean, snap, succulent-babyfood     0.025000   1.000     
1.000   

06030980 6C   Chickpea, seed                     0.025000   1.000     
1.000   

06030981 6C   Chickpea, seed-babyfood            0.025000   1.000     
1.000   

06030990 6C   Chickpea, flour                    0.025000   1.000     
1.000   

95001280 O    Cottonseed, oil                    0.025000   1.000     
1.000   

95001281 O    Cottonseed, oil-babyfood           0.025000   1.000     
1.000   

06031820 6C   Guar, seed                         0.025000   1.000     
1.000   

06031821 6C   Guar, seed-babyfood                0.025000   1.000     
1.000   

06032030 6C   Lentil, seed                       0.025000   1.000     
1.000   

06032560 6C   Pea, dry                           0.025000   1.000     
1.000   

06032561 6C   Pea, dry-babyfood                  0.025000   1.000     
1.000   

06032580 6C   Pea, pigeon, seed                  0.025000   1.000     
1.000   

06003470 6    Soybean, seed                      0.020000   1.000     
1.000   

06003480 6    Soybean, flour                     0.020000   1.000     
1.000   

06003481 6    Soybean, flour-babyfood            0.020000   1.000     
1.000   

06003490 6    Soybean, soy milk                  0.020000   1.000     
1.000   

06003491 6    Soybean, soy milk-babyfood or in   0.020000   1.000     
1.000   

06003500 6    Soybean, oil                       0.020000   1.000     
1.000   

06003501 6    Soybean, oil-babyfood              0.020000   1.000     
1.000   

86010000 O    Water, direct, all sources         0.001000   1.000     
1.000   

86020000 O    Water, indirect, all sources       0.001000   1.000     
1.000   

Attachment 4:  DEEM-FCID™ Chronic Food plus Ground Water Results file.

U.S. Environmental Protection Agency                                
Ver. 2.00

DEEM-FCID Chronic analysis for FOMESAFEN SODIUM                 (1994-98
data)

Residue file name: C:\2004DEEMFCID\Fomesafen\FomesafenDietary
Assessment\Fomesafen_chronic_groundH2O.R98

                                                 Adjustment factor #2
NOT used.

Analysis Date 01-26-2006/08:44:35     Residue file dated:
01-25-2006/15:58:50/8

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

NOEL (Chronic) = .25 mg/kg bw/day

COMMENT 1: FQPA SF of 1X; ground water

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

                    Total exposure by population subgroup

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

                                                    Total Exposure

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

          Population                         mg/kg       Margin of  
Percent 

           Subgroup                       body wt/day   Exposure 1/  of
RfD 

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

U.S. Population (total)                     0.000038        6,639       
1.5%

U.S. Population (spring season)             0.000037        6,750       
1.5%

U.S. Population (summer season)             0.000039        6,405       
1.6%

U.S. Population (autumn season)             0.000037        6,680       
1.5%

U.S. Population (winter season)             0.000037        6,740       
1.5%

Northeast region                            0.000034        7,440       
1.3%

Midwest region                              0.000038        6,594       
1.5%

Southern region                             0.000038        6,662       
1.5%

Western region                              0.000041        6,064       
1.6%

Hispanics                                   0.000044        5,720       
1.7%

Non-hispanic whites                         0.000036        6,913       
1.4%

Non-hispanic blacks                         0.000038        6,589       
1.5%

Non-hisp/non-white/non-black                0.000047        5,317       
1.9%

All infants (< 1 year)                      0.000107        2,329       
4.3%

Nursing infants                             0.000043        5,827       
1.7%

Non-nursing infants                         0.000132        1,897       
5.3%

Children 1-6  yrs                           0.000066        3,808       
2.6%

Children 7-12 yrs                           0.000041        6,065       
1.6%

Females 13-19 (not preg or nursing)         0.000028        8,957       
1.1%

Females 20+ (not preg or nursing)           0.000033        7,526       
1.3%

Females 13-50 yrs                           0.000034        7,264       
1.4%

Females 13+ (preg/not nursing)              0.000035        7,230       
1.4%

Females 13+ (nursing)                       0.000046        5,416       
1.8%

Males 13-19 yrs                             0.000031        7,953       
1.3%

Males 20+ yrs                               0.000033        7,596       
1.3%

Seniors 55+                                 0.000033        7,571       
1.3%

Children 1-2 yrs                            0.000072        3,457       
2.9%

Children 3-5 yrs                            0.000064        3,887       
2.6%

Children 6-12 yrs                           0.000044        5,746       
1.7%

Youth 13-19 yrs                             0.000030        8,395       
1.2%

Adults 20-49 yrs                            0.000033        7,536       
1.3%

Adults 50+ yrs                              0.000033        7,543       
1.3%

Females 13-49 yrs                           0.000032        7,740       
1.3%

------------------------------------------------------------------------
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PC Code: 123802	                                                        
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PC Code: 123802	                                                        
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Fomesafen Sodium	Dietary Exposure Assessment	DP Barcode: D325798

PC Code: 123802	                                                        
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