UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

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

		

OFFICE OF CHEMICAL SAFETY AND POLLUTION PREVENTION	

DATE: 	October 12, 2010

  SEQ CHAPTER \h \r 1 MEMORANDUM

SUBJECT:	  SEQ CHAPTER \h \r 1 Fomesafen Sodium: Chronic Dietary
Exposure Assessment to Support Proposed New Use on Potatoes and Peppers.

		

PC Code:  123802	DP Barcode:  D382064

Decision No.:  425353	Registration No.:  100-993

Petition Nos:  9F7563 (potato), 9F7667 (pepper)	Regulatory Action: 
Section 3 and Registration

Risk Assessment Type:  NA	Case No.:  NA

TXR No.:  NA	CAS No.:  72178-02-0

MRID No.:  NA	40 CFR:  §180.433

	

FROM:	Alexandra LaMay, Biologist

		Risk Assessment Branch VII

		Health Effects Division (7509P)

THROUGH:	Breann Hanson  SEQ CHAPTER \h \r 1 , Chemist

Thurston Morton, Chemist

Dietary Exposure Science Advisory Council (DESAC)

		Health Effects Division (7509P)

	

			and	

		

		Michael S. Metzger, Branch Chief

		Risk Assessment Branch VII

		Health Effects Division (7509P)

TO:		  SEQ CHAPTER \h \r 1 Michael Walsh, PM Team 23

	Herbicide Branch

	Registration Division (7505P)

This document is a revision of the Chronic Dietary Exposure Assessments
dated January 21, 2010 (C. Olinger).  The dietary assessments have been
updated
t⁯湩汣摵⁥桴⁥牰灯獯摥渠睥甠敳⁳景映浯獥晡湥椠
⽮湯瀠瑯瑡敯⁳湡⁤数灰牥⹳†഍–䕓⁑䡃偁䕔⁒桜尠
⁲ᔱ硅捥瑵癩⁥畓浭牡൹

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 a
proposed new use of fomesafen sodium (commonly called fomesafen) on
potatoes and peppers. 

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 (Food and Drinking Water) Exposure
Results and Characterization

Chronic dietary exposure assessments were performed for fomesafen
sodium.  The assumptions of these unrefined assessments were tolerance
level residues, 100% crop treated, and default DEEM processing factors. 
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 water that are below the Agency’s level of concern for
chronic dietary exposure for all population subgroups.  The exposure for
food plus drinking water to the general U.S. population is 12% of the
chronic population adjusted dose (cPAD).  The subgroup with the highest
exposure and risk estimates is infants.  For infants, the exposure for
food plus drinking water was 0.000813 mg/kg/day, which represents 32% of
the cPAD.

  SEQ CHAPTER \h \r 1 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
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 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.  HED is generally
concerned when estimated cancer risk exceeds one in one million.
References which 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:      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 (20-AUG-1999).

The most recent dietary risk assessment for fomesafen was conducted by
Christine Olinger (1/21/2010, DP No. 372850).  

  SEQ CHAPTER \h \r 1 II.  Residue Information

  SEQ CHAPTER \h \r 1 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 soybeans and other
legumes.

  SEQ CHAPTER \h \r 1 Tolerances for fomesafen residues are listed in 40
CFR §180.433.  Currently tolerances are established for fomesafen acid
in soybeans, dry beans, and snap (succulent) beans at 0.05 ppm and
cotton gin by-products and cottonseed at 0.025 ppm.  Since then, HED has
recommended that tolerances on dry beans and snap (succulent) beans be
reduced to 0.025 ppm and the tolerance on soybeans be reduced to 0.02
ppm (D. Davis, DP No. D325801, 4/25/06).  The registrant has also since
proposed new tolerances and uses on tomatoes and potatoes; however,
insufficient residue data were available for potatoes.  Therefore, only
a tolerance of 0.025 ppm in/on tomatoes was recommended (C. Olinger, DP
No. 365199, 1/21/2010).  Since then, a confined rotational crop
metabolism study has been submitted that satisfies the data gap for
potatoes, therefore it has been recommended for a tolerance of 0.025 ppm
in/on potatoes.  In this petition, the registrant has proposed a new
tolerance and use on peppers.  Based on the residue data available, HED
is recommending for a tolerance of 0.025 ppm in/on peppers (A. LaMay, DP
No. 373544 and 382067, 10/12/2010).

-α,α,α-trifluoro-p-tolyloxy) anthranilic acid and
5-(2-chloro-α,α,α-trifluoro-p-tolyloxy)-N-methylsulfonylanthranilamid
e.  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.  The tomato processing study
previously submitted was inadequate due to the lack of detectable
residues in/on the raw commodity.  Therefore, default tomato paste,
dried tomato, tomato juice, and tomato puree concentration factors were
used for these processed commodities.  The potato processing study
previously submitted was also inadequate due to lack of detectable
residues in/on the raw commodity.  Therefore, default dried potato
concentration factors were used for these processed commodities.  

  Drinking Water Data

The drinking water residues used in the dietary risk assessment were
provided by the Environmental Fate and Effects Division (EFED) in the
following memoranda: 

Hetrick, James.  DP Barcode: D322213. October 3, 2005. Revised Tier II
Drinking Water Assessment for Fomesafen use on cotton, soybeans, dry
beans, and snap beans

Lin, James.  DP Barcode: D365204.  December 10, 2009.  Drinking Water
Assessment for Fomesafen use on cotton, soybeans, dry beans, snap beans,
potato and tomato.

Lin, James.  DP Barcode: D373599 and 373601.  March 2, 2010.  Drinking
Water Assessment for Fomesafen use on Pepper.

The estimated drinking water concentrations (EDWCs) were incorporated
directly into DEEM-FCID under the food categories “water, direct, all
sources” and “water, indirect, all sources.”   

The scenario leading to the highest EDWC in surface water for chronic
exposure (1-in-10 year annual mean concentration) using Pesticide Root
Zone Model- Exposure Analysis Modeling System (PRZM-EXAMS) was MS
cotton, aerial application, with a concentration of 10.535 ppb, adjusted
for a Percent Crop Area (PCA) of 0.87.  This value was used directly in
the dietary exposure assessment.

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.  Since this
value was lower than the surface water EDWC, only the surface water
value was incorporated into the assessment.

The model and its description are available at the EPA internet site:  
HYPERLINK "http://www.epa.gov/oppefed1/models/water/" 
http://www.epa.gov/oppefed1/models/water/ .  

  SEQ CHAPTER \h \r 1 IV.  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 V.  Toxicological Information

Fomesafen has low acute toxicity by the oral route of exposure. It is
severely irritating to the eye and is a moderate skin irritant. In the
subchronic and chronic feeding studies, the consistent finding is the
effect in the liver characterized by increases in liver weight and in
associated enzymes including alkaline phosphatase, alanine transaminase,
and aspartate transaminase. Hyalinization of the liver is also observed.
 Currently, the toxicity database is adequate in establishing the
toxicity endpoints for risk assessment.  No toxicity studies have been
received since the last human health risk assessment (A. LaMay, D373963
2/19/2010).  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 selected for
dietary risk assessment may be found in Table 1 below.

Table 1.  Summary of Toxicological Doses and Endpoints for Fomesafen for
Use in Dietary Exposure Risk Assessments

Exposure/

Scenario	Point of Departure	Uncertainty/FQPA Safety Factors	RfD, PAD,
Level of Concern 	Study and Toxicological Effects

Acute Dietary 	No toxic affects attributable to a single dose of
fomesafen were found in any study. 

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 - rat

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

Cancer (oral, dermal, inhalation)   	Classification: “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 (intraspecies).  UFH =
potential variation in sensitivity among members of the human population
(interspecies).  FQPA SF = FQPA Safety Factor.  PAD = population
adjusted dose (a = acute, c = chronic).  RfD = reference dose.  

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

xceeds 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 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.

  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.  All risk estimates are below the level of concern for all
population subgroups assessed for food and drinking water exposures. 
The exposure for food plus drinking water to the general U.S. population
is 12% of the cPAD.  When considering food alone, the highest exposure
is for children ages 1-2, at 0.000207 mg/kg/day, which represents 8.3%
of the cPAD.  However, the population subgroup with the highest exposure
when considering both food and drinking water and risk estimates is all
infants.  The exposure for food plus drinking water was 0.000813
mg/kg/day, which utilized 32% of the cPAD.  The results of the chronic
dietary analyses are reported in Table 2 below.

Table 2.  Summary of Chronic Dietary (Food and Drinking Water) Exposure
and Risk for Fomesafen

Population Subgroup	Food Alone	Food and Drinking Water2

	Dietary Exposure (mg/kg/day)	% cPAD1	Dietary Exposure

(mg/kg/day)	% cPAD1

General U.S. Population	0.000086	3.4	0.000308	12

All Infants (< 1 year old)	0.000085	3.4	0.000813	32

Children 1-2 years old	0.000207	8.3	0.000536	22

Children 3-5 years old	0.000184	7.3	0.000492	20

Children 6-12 years old	0.000124	4.9	0.000336	14

Youth 13-19 years old	0.000086	3.4	0.000247	9.9

Adults 20-49 years old	0.000073	2.9	0.000280	11

Adults 50+ years old	0.000063	2.5	0.000281	11

Females 13-49 years old	0.000068	2.7	0.000275	11

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

2 The estimated drinking water concentration used in this analysis is
from the PRZM-EXAMS modeling of surface water of the MS cotton scenario.

  SEQ CHAPTER \h \r 1 VII.	Conclusions

An unrefined chronic 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.  When considering
exposure to fomesafen in food and drinking water the highest exposure
and risk estimates were for infants, whose exposure is at 32% of the
cPAD. 

  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 Alone Results file.

Attachment 3:  DEEM-FCID™ Chronic Food plus Surface Water Results
file.

.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                         
1994-98 data

Residue file: C:\Documents and Settings\ALEMAY\My Documents\Fomesafen-
peanuts peppers\Dietary Assessment\Old
dietary\Fomesafen_Chronic_Pepper_foodandwater.R98

                                                           Adjust. #2
NOT used

Analysis Date 05-18-2010             Residue file dated:
05-18-2010/09:52:53/8

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

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

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   

08002700 8    Pepper, bell                       0.025000   1.000     
1.000   

08002701 8    Pepper, bell-babyfood              0.025000   1.000     
1.000   

08002710 8    Pepper, bell, dried                0.025000   1.000     
1.000   

08002711 8    Pepper, bell, dried-babyfood       0.025000   1.000     
1.000   

08002720 8    Pepper, nonbell                    0.025000   1.000     
1.000   

08002721 8    Pepper, nonbell-babyfood           0.025000   1.000     
1.000   

08002730 8    Pepper, nonbell, dried             0.025000   1.000     
1.000   

01032960 1C   Potato, chips                      0.025000   1.000     
1.000   

01032970 1C   Potato, dry (granules/ flakes)     0.025000   6.500     
1.000   

01032971 1C   Potato, dry (granules/ flakes)-b   0.025000   6.500     
1.000   

01032980 1C   Potato, flour                      0.025000   6.500     
1.000   

01032981 1C   Potato, flour-babyfood             0.025000   6.500     
1.000   

01032990 1C   Potato, tuber, w/peel              0.025000   1.000     
1.000   

01032991 1C   Potato, tuber, w/peel-babyfood     0.025000   1.000     
1.000   

01033000 1C   Potato, tuber, w/o peel            0.025000   1.000     
1.000   

01033001 1C   Potato, tuber, w/o peel-babyfood   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   

08003750 8    Tomato                             0.025000   1.000     
1.000   

08003751 8    Tomato-babyfood                    0.025000   1.000     
1.000   

08003760 8    Tomato, paste                      0.025000   5.400     
1.000   

08003761 8    Tomato, paste-babyfood             0.025000   5.400     
1.000   

08003770 8    Tomato, puree                      0.025000   3.300     
1.000   

08003771 8    Tomato, puree-babyfood             0.025000   3.300     
1.000   

08003780 8    Tomato, dried                      0.025000  14.300     
1.000   

08003781 8    Tomato, dried-babyfood             0.025000  14.300     
1.000   

08003790 8    Tomato, juice                      0.025000   1.500     
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 Alone Results file.  

U.S. Environmental Protection Agency                                
Ver. 2.00

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

Residue file name: C:\Documents and Settings\ALEMAY\My
Documents\Fomesafen- peanuts peppers\Dietary Assessment\Old
dietary\Fomesafen_Chronic_Pepper_foodonly.R98

                                                 Adjustment factor #2
NOT used.

Analysis Date 05-18-2010/09:55:11     Residue file dated:
05-18-2010/09:51:41/8

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

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

                    Total exposure by population subgroup

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

                                                    Total Exposure

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

          Population                         mg/kg             Percent
of   

           Subgroup                       body wt/day             Rfd   
   

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

U.S. Population (total)                     0.000086                
3.4%

U.S. Population (spring season)             0.000085                
3.4%

U.S. Population (summer season)             0.000085                
3.4%

U.S. Population (autumn season)             0.000087                
3.5%

U.S. Population (winter season)             0.000088                
3.5%

Northeast region                            0.000083                
3.3%

Midwest region                              0.000091                
3.6%

Southern region                             0.000085                
3.4%

Western region                              0.000086                
3.5%

Hispanics                                   0.000100                
4.0%

Non-hispanic whites                         0.000084                
3.4%

Non-hispanic blacks                         0.000084                
3.4%

Non-hisp/non-white/non-black                0.000088                
3.5%

All infants (< 1 year)                      0.000085                
3.4%

Nursing infants                             0.000034                
1.4%

Non-nursing infants                         0.000104                
4.1%

Children 1-6  yrs                           0.000187                
7.5%

Children 7-12 yrs                           0.000117                
4.7%

Females 13-19 (not preg or nursing)         0.000081                
3.2%

Females 20+ (not preg or nursing)           0.000063                
2.5%

Females 13-50 yrs                           0.000074                
3.0%

Females 13+ (preg/not nursing)              0.000073                
2.9%

Females 13+ (nursing)                       0.000071                
2.8%

Males 13-19 yrs                             0.000092                
3.7%

Males 20+ yrs                               0.000075                
3.0%

Seniors 55+                                 0.000062                
2.5%

Children 1-2 yrs                            0.000207                
8.3%

Children 3-5 yrs                            0.000184                
7.3%

Children 6-12 yrs                           0.000124                
4.9%

Youth 13-19 yrs                             0.000086                
3.4%

Adults 20-49 yrs                            0.000073                
2.9%

Adults 50+ yrs                              0.000063                
2.5%

Females 13-49 yrs    
†††††††††††⸰〰〰㠶††††††††㈠
㜮ഥⴭⴭⴭⴭⴭⴭⴭⴭⴭⴭⴭⴭⴭⴭⴭⴭⴭⴭⴭⴭⴭⴭ
ⴭⴭⴭⴭⴭⴭⴭⴭⴭⴭⴭⴭⴭഭ

Attachment 3:  DEEM-FCID™ Chronic Food plus Surface Water Results
file.  

U.S. Environmental Protection Agency                                
Ver. 2.00

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

Residue file name: C:\Documents and Settings\ALEMAY\My
Documents\Fomesafen- peanuts peppers\Dietary Assessment\Old
dietary\Fomesafen_Chronic_Pepper_foodandwater.R98

                                                 Adjustment factor #2
NOT used.

Analysis Date 05-18-2010/09:57:09     Residue file dated:
05-18-2010/09:52:53/8

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

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

                    Total exposure by population subgroup

 

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

                                                    Total Exposure

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

          Population                         mg/kg             Percent
of   

           Subgroup                       body wt/day             Rfd   
   

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

U.S. Population (total)                     0.000308               
12.3%

U.S. Population (spring season)             0.000305               
12.2%

U.S. Population (summer season)             0.000324               
13.0%

U.S. Population (autumn season)             0.000302               
12.1%

U.S. Population (winter season)             0.000303               
12.1%

Northeast region                            0.000285               
11.4%

Midwest region                              0.000315               
12.6%

Southern region                             0.000296               
11.8%

Western region                              0.000341               
13.6%

Hispanics                                   0.000352               
14.1%

Non-hispanic whites                         0.000301               
12.0%

Non-hispanic blacks                         0.000295               
11.8%

Non-hisp/non-white/non-black                0.000360               
14.4%

All infants (< 1 year)                      0.000813               
32.5%

Nursing infants                             0.000304               
12.2%

Non-nursing infants                         0.001005               
40.2%

Children 1-6  yrs                           0.000498               
19.9%

Children 7-12 yrs                           0.000319               
12.7%

Females 13-19 (not preg or nursing)         0.000237                
9.5%

Females 20+ (not preg or nursing)           0.000285               
11.4%

Females 13-50 yrs                           0.000289               
11.6%

Females 13+ (preg/not nursing)              0.000289               
11.5%

Females 13+ (nursing)                       0.000378               
15.1%

Males 13-19 yrs                             0.000255               
10.2%

Males 20+ yrs                               0.000274               
10.9%

Seniors 55+                                 0.000280               
11.2%

Children 1-2 yrs                            0.000536               
21.5%

Children 3-5 yrs                            0.000492               
19.7%

Children 6-12 yrs                           0.000336               
13.5%

Youth 13-19 yrs                             0.000247                
9.9%

Adults 20-49 yrs                            0.000280               
11.2%

Adults 50+ yrs                              0.000281               
11.2%

Females 13-49 yrs                           0.000275               
11.0%

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

 PAGE   

Fomesafen Sodium	Dietary Exposure Assessment	DP Number: D382064

PC Code: 123802	                                                        
                                                               Page  
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Fomesafen Sodium	Dietary Exposure Assessment	DP Barcode: D??????

PC Code: 123802	                                                        
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