  SEQ CHAPTER \h \r 1 

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C. 20460      

	OFFICE OF PREVENTION, PESTICIDESs

                                                                        
                   AND TOXIC SUBSTANCES

	

MEMORANDUM

Date:  		04-MAR-2010  

SUBJECT:	Halosulfuron-methyl Acute and Chronic Aggregate Dietary (Food
and Drinking Water) Exposure and Risk Assessments for the Section 3
Registration Action on Pea and Bean, Succulent Shelled, Subgroup 6B;
Vegetable, Tuberous and Corm, Subgroup 1C; Rhubarb; Bushberry Subgroup
13-07B; Apple; and Okra.

PC Code:  128721	DP Barcode:  D367059

Decision No.:  414896	Registration Nos.:  81880-18 and 81880-2

Petition No.:  9E7577	Regulatory Action:  Section 3 Registration

Risk Assessment Type:  NA	Case No.:  NA

TXR No.:  NA	CAS No.:  100784-20-1

MRID Nos.:  NA	40 CFR:  §180.479



FROM:	Debra Rate, Ph.D., Biologist

	Alternative Risk Integration and Assessment (ARIA) Team

	Risk Integration, Minor Use and Emergency Response Branch (RIMUERB)

Registration Division (RD; 7505P)

THROUGH:	Thurston Morton, Chemist

Breann Hanson, Biologist

Dietary Exposure Science Advisory Council (DESAC)

Health Effects Division (HED; 7509P)

and

	William Cutchin, Acting Senior Branch Scientist

	ARIA/RIMUERB/RD (7505P)

TO:		Whang Phang, Toxicologist 

		Risk Assessment Branch III (RABIII)

		HED (7509P)

		Vickie Walters/James Tompkins (RM Team #25)

		Herbicide Branch (HB)/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 DEEM-FCID™, Version 2.03, which uses food consumption
data from the U.S. 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 Section 3 request for new uses
on pea and bean, succulent shelled, Subgroup 6B; vegetable, tuberous and
corm, Subgroup 1C; rhubarb; bushberry Subgroup 13-07B; apple; and okra.

     

Acute Dietary (Food and Drinking Water) Exposure Results and
Characterization

An acute dietary (food and drinking water) exposure assessment was
conducted for the proposed uses on pea and bean, succulent shelled,
Subgroup 6B; vegetable, tuberous and corm, Subgroup 1C; rhubarb;
bushberry Subgroup 13-07B; apple; and okra; all established uses; and
drinking water.  An unrefined assessment was conducted.  The residue
levels used in the assessment for all commodities were the established
or recommended tolerance levels (DP#367058, D. Rate, 03/03/2010).  The
assessment was conducted using the assumption that 100% of the crop was
treated (100%CT).  Default (DEEM 7.81) processing factors were used
unless processing studies were available.  For some commodities,
processing studies showed that residues do not concentrate upon
processing (i.e. tomato paste, tomato puree, potato flour and potato
granules/flakes).  

Estimated concentrations of halosulfuron-methyl in drinking water from
use on rice, which reflected the highest use rate, were provided by the
Environmental Fate and Effects Division (EFED) and incorporated directly
into the acute assessment.  A Tier 1 drinking water assessment for the
use on rice was performed using the FQPA Index Reservoir Screening Tool
(FIRST) modeling.  The acute estimated drinking water concentration
(acute EDWC) of halosulfuron-methyl is not expected to exceed 59.2 ppb
(0.0592 ppm).

  

The acute dietary (food and drinking water) exposure to
halosulfuron-methyl is below ARIA’s level of concern for the general
U.S. population and all population subgroups.  For the general U.S.
population, an appropriate dose/endpoint attributable to a single dose
was not observed in the reviewed oral toxicity studies.  The acute
dietary exposure estimate at the 95th percentile is <1% of the aPAD for
females 13-49 years old, the only population subgroup of concern.

Chronic Dietary (Food and Drinking Water) Exposure Results and
Characterization

A chronic dietary (food and drinking water) exposure assessment was
conducted for the recommended uses on pea and bean, succulent shelled,
Subgroup 6B; vegetable, tuberous and corm, Subgroup 1C; rhubarb;
bushberry Subgroup 13-07B; apple; and okra; all established uses; and
drinking water.  An unrefined assessment was conducted.  The residue
levels used in the assessment for all commodities were the established
or recommended tolerance levels.  The assessment was conducted using the
assumption of 100% CT.  Default (DEEM 7.81) processing factors were used
unless processing studies were available.  For some commodities,
processing studies showed that residues do not concentrate upon
processing (i.e. tomato paste, tomato puree, potato flour and potato
granules/flakes).  

Estimated concentrations of halosulfuron-methyl in drinking water from
use on rice, which reflected the highest use rate, were provided by EFED
and incorporated directly into the chronic assessment.  A Tier 1
drinking water assessment for the use on rice was performed using FIRST
modeling.  The annual mean (chronic) estimated drinking water
concentration (chronic EDWC) of halosulfuron-methyl is not expected to
exceed 59.2 ppb (0.0592 ppm).

The chronic dietary (food and drinking water) exposure to
halosulfuron-methyl is below ARIA’s level of concern for the general
U.S. population and all population subgroups.  The chronic dietary
exposure estimates are 2% of the cPAD for the general U.S. population
and 5% of the cPAD for all infants (<1 year old), the most highly
exposed population subgroup.

Cancer Dietary (Food and Drinking Water) Exposure Results and
Characterization

The HIARC classified halosulfuron-methyl as “not likely to be a human
carcinogen;” therefore, quantification of human cancer risk is not
required.

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, ARIA is concerned when
estimated dietary risk exceeds 100% of the PAD.  ARIA 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 halosulfuron-methyl was
conducted by Nancy Dodd (DP#359457, 05/29/2009).

II.	Residue Information

Halosulfuron-methyl Use:

Interregional Research Project No. 4 (IR-4) has proposed new uses of
halosulfuron-methyl on:  apple; bushberry Subgroup 13-07B; okra;
succulent-shelled pea and bean Subgroup 6B; dried shelled pea and bean,
except soybean, Subgroup 6C; rhubarb; and tuberous and corm vegetable
Subgroup 1C.  A tolerance of 0.05 ppm on each of these commodities or
crop groups/subgroups is proposed.  ARIA has recommended in favor of
these tolerances, with the exception of dried shelled pea and bean,
except soybean, Subgroup 6C.  The existing individual tolerance on bean,
dry seed (0.05 ppm) was included in the assessment.

Permanent tolerances are established under §180.479(a)(1) for residues
of halosulfuron-methyl and its metabolites determined as
3-chloro-1-methyl-5-sulfamoylpyrazole-4-carboxylic acid, expressed as
halosulfuron-methyl equivalents, in/on the meat byproducts of cattle,
goat, hog, horse, and sheep at 0.1 ppm.  Tolerances are established
under §180.479(a)(2) for residues of halosulfuron-methyl in/on a
variety of field, fruit, and vegetable crop commodities, at levels
ranging from 0.05 to 2.0 ppm.  A time-limited tolerance for sweet
potato, established under §180.479(b), has expired (expiration date
12/31/08).  

The Metabolism Committee has concluded that the residue of concern in
target plants, rotational plants, and livestock is halosulfuron-methyl
(G. J. Herndon, No DP#s, 9/16/1993 and 5/21/1996).  Although HED
concluded that the residue of concern in livestock is
halosulfuron-methyl, tolerances for residues in livestock commodities
are expressed in terms of halosulfuron-methyl and its metabolites
determined as 3-chloro-1-methyl-5-sulfamoylpyrazole-4-carboxylic acid,
expressed as halosulfuron-methyl equivalents, because the enforcement
method for livestock commodities quantifies the parent and metabolites
containing the 3-chlorosulfonamide moiety (3-CSA) by converting residues
to 3-CSA.  

The residue of concern in water is halosulfuron-methyl.  The parent is
mobile and persistent.

Residue Data used for Acute and Chronic Assessments:

These acute and chronic assessments are unrefined assessments using
tolerance-level residues and 100% CT for all commodities with proposed
and established tolerances.

No changes in the established livestock tolerances are being recommended
as a result of the proposed uses.

Default (DEEM 7.81) processing factors were used unless processing
studies were available.  The processing factors which were used were
1.5X for field corn syrup, 14.3X for dried tomato, 1.5X for tomato
juice, 8.0X for dried apple, and 1.3X for apple juice.  For some
commodities, processing studies showed that residues do not concentrate
upon processing (i.e. tomato paste, tomato puree, potato flour and
potato granules/flakes).  

  Drinking Water Data

The drinking water residues used in the dietary risk assessment were
provided by EFED in the following memorandum: “Halosulfuron-methyl
Drinking Water Assessment for Additional Food Uses (including Proposed
Use on Soybean)” (DP#358032, M. Barrett, 5/27/2009) 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.”  Since the
application rates associated with the proposed new uses did not exceed
the application rate on rice (0.125 lb ai/A), a new drinking water
assessment was not required for this dietary analysis.         

The Tier I EDWCs for halosulfuron-methyl are based on a maximum annual
application rate of 0.125 lb ai/A for rice.  The two screening models,
FIRST and Screening Concentrations in Ground Water (SCI-GROW), were used
for estimating EDWCs of halosulfuron-methyl.  Estimates for
halosulfuron-methyl in surface water based on the FIRST model for rice
are 59.2 ppb for acute and chronic concentrations.  It should be noted
that the drinking water estimate based on rice application is an upper
bound estimate.  The estimate for halosulfuron-methyl in groundwater
based on the SCI-GROW model result is 0.065 ppb.  Table 1 summarizes the
results.

Table 1.  Summary of Estimated Surface Water and Groundwater
Concentrations for Halosulfuron-methyl.

	Surface Water Conc., ppb a	Groundwater Conc., ppb b

Acute	59.2	0.065

Chronic (non-cancer)	59.2	0.065

a From the FIRST model.  

b From the SCI-GROW model.

Halosulfuron-methyl, like most other sulfonylurea herbicides, is
extremely mobile with a median Koc of 104 g/mL and Kf (Freundlich
partition) values ranging from 0.32 to 3.6 in four test soils.  Its
persistence in soil and water appears to be highly variable. 
Halosulfuron-methyl has the potential to leach to groundwater, and also
presents concerns for transport to surface water by runoff. 

The FIRST and SCI-GROW models and their descriptions are available at
the EPA internet site:   HYPERLINK
"http://www.epa.gov/oppefed1/models/water/" 
http://www.epa.gov/oppefed1/models/water/ .  

IV.	DEEM-FCID™ Program and Consumption Information

Halosulfuron-methyl acute and 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.

For acute exposure assessments, individual one-day food consumption data
are used on an individual-by-individual basis.  The reported consumption
amounts of each food item can be multiplied by a residue point estimate
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 all tiers of analysis.  However, for unrefined
assessments, any significant differences in user vs. per capita exposure
and risk are specifically identified and noted in the risk assessment.

V.  Toxicological Information

The risk assessment team confirmed endpoints that were previously
selected and confirmed the reduction to 1X of the FQPA Safety Factor for
all population subgroups (DP#358031, W. Phang, 06/30/2009).  

Halosulfuron-methyl is classified as “not likely to be carcinogenic to
humans” based on a lack of evidence of carcinogenicity in male and
female mice and rats.  Therefore, halosulfuron-methyl is not expected to
pose a cancer risk for humans.

Toxicological endpoints for use in dietary exposure risk assessments are
summarized in Table 2 below. 

Table 2.  Summary of Toxicological Doses and Endpoints for
Halosulfuron-methyl 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

(Females 13-49 years of age)	NOAEL= 50 mg/kg/day	UFA= 10x

UFH= 10x

FQPA SF= 1x	Acute RfD = 0.5 mg/kg/day

aPAD =0.5 mg/kg/day	Developmental Toxicity - Rabbit

LOAEL = 150 mg/kg/day based on decreased mean litter size, increased
number of resorptions (total and per dam) and increased postimplantation
loss. (developmental toxicity)

Acute Dietary (General Population, including Infants and Children)	N/A
N/A	N/A	No appropriate dose/endpoint selected.



Chronic Dietary (All Populations)	NOAEL= 10 mg/kg/day	UFA= 10x

UFH= 10x

FQPA SF= 1x 	Chronic RfD = 0.1

mg/kg/day

cPAD = 0.1 mg/kg/day	Chronic Toxicity - Dog

LOAEL = 40 mg/kg/day based on decreased body weight gains in females.

Cancer (oral, dermal, inhalation)	Classification: “not likely to be
carcinogenic to humans” by the oral route, based on no evidence of
carcinogenicity from studies in rats and mice.

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).  FQPA SF = FQPA Safety Factor.  PAD = population
adjusted dose (a = acute, c = chronic).  RfD = reference dose.  N/A =
not applicable.

VI.	Results/Discussion

As stated above, for acute and chronic dietary assessments, ARIA is
concerned when dietary risk exceeds 100% of the PAD.  The DEEM-FCID(
analyses estimate the dietary exposure of the U.S. population and
various population subgroups.  The results reported in Table 3 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 (Food and Drinking Water) Exposure Analysis    

The results of the acute (food and drinking water) dietary exposure
analysis are reported in Table 3 below.  The acute dietary exposure
estimate at the 95th percentile is <1% of the aPAD for females 13-49
years old, the only population subgroup of concern.

Results of Chronic Dietary (Food and Drinking Water) Exposure Analysis

The results of the chronic dietary (food and drinking water) exposure
analysis are reported in Table 3 below.  The chronic dietary (food and
drinking water) exposure to halosulfuron-methyl is below ARIA’s level
of concern for the general U.S. population and all population subgroups.
 The chronic dietary exposure estimates are 2% of the cPAD for the
general U.S. population and 5% of the cPAD for all infants (<1 year
old), the most highly exposed population subgroup.

Table 3.  Summary of Dietary Exposure and Risk for Halosulfuron-methyl. 


Population Subgroup	Acute Dietary 

(95th Percentile)	Chronic Dietary

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

(mg/kg/day)	% cPAD*

General U.S. Population	N/A	N/A	0.001705	2

All Infants (< 1 year old)

	0.005059	5

Children 1-2 years old

	0.003157	3

Children 3-5 years old

	0.002823	3

Children 6-12 years old

	0.001859	2

Youth 13-19 years old

	0.001327	1

Adults 20-49 years old

	0.001511	2

Adults 50+ years old

	0.001558	2

Females 13-49 years old	0.003401	<1	0.001503	2

The population subgroup with the highest estimated exposure/risk is
bolded.

VII.	Characterization of Inputs/Outputs

An unrefined assessment was conducted.  The residue levels used in the
assessment for all commodities were the established or recommended
tolerance levels.  The assessment was conducted using the assumption
that 100% of the crop was treated.  Default (DEEM 7.81) processing
factors were used unless processing studies were available.  For some
commodities, processing studies showed that residues do not concentrate
upon processing (i.e. tomato paste, tomato puree, potato flour and
potato granules/flakes).  

The assessment could be refined with percent crop treated estimates,
anticipated residues, or monitoring data.  Since risk estimates are well
below ARIA’s level of concern, a more highly refined analysis is not
needed at this time.

Conclusions

Acute and chronic dietary exposure assessments were conducted for the
proposed uses on pea and bean, succulent shelled, Subgroup 6B;
vegetable, tuberous and corm, Subgroup 1C; rhubarb; bushberry Subgroup
13-07B; apple; and okra.  The analyses were unrefined assessments, using
the proposed or established tolerances for all commodities, using the
assumption of 100% CT, and default (DEEM 7.81) processing factors when
appropriate.  

For both of the acute and chronic assessments, the general U.S.
population and all population subgroups have risk estimates which are
below ARIA’s level of concern.  

IX.		List of Attachments

Attachment 1:  Acute and Chronic Food plus Water Residue Input File

Attachment 2:  Acute Results File

Attachment 3:  Chronic Results File

cc:  D. Rate, W. Phang 

Attachment 1:  Acute and Chronic Food plus Water Residue Input File

U.S. Environmental Protection Agency                                
Ver. 2.00

DEEM-FCID Chronic analysis for HALOSULFURON-METHYL               
1994-98 data

Residue file: C:\Documents and
Settings\drate\Desktop\Halosulfuron\DEEM\acute & chronic 128721.R98

                                                           Adjust. #2
NOT used

Analysis Date 02-17-2010             Residue file dated:
02-17-2010/13:45:22/8

Reference dose (RfD) = 0.1  (NOEL) = 10 mg/kg bw/day

Comment:Acute is only for Females 13-49 yrs

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

Food Crop                                       Residue      
Adj.Factors      Comment

EPA Code  Grp  Food Name                          (ppm)       

                                                             #1        
#2 

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

14000030 14   Almond                             0.050000   1.000     
1.000   8F4937

14000031 14   Almond-babyfood                    0.050000   1.000     
1.000   

14000040 14   Almond, oil                        0.050000   1.000     
1.000   8F4937

14000041 14   Almond, oil-babyfood               0.050000   1.000     
1.000   

11000070 11   Apple, fruit with peel             0.050000   1.000     
1.000   9E7577

11000080 11   Apple, peeled fruit                0.050000   1.000     
1.000   9E7577

11000081 11   Apple, peeled fruit-babyfood       0.050000   1.000     
1.000   9E7577

11000090 11   Apple, dried                       0.050000   8.000     
1.000   9E7577

11000091 11   Apple, dried-babyfood              0.050000   8.000     
1.000   9E7577

11000100 11   Apple, juice                       0.050000   1.300     
1.000   9E7577

11000101 11   Apple, juice-babyfood              0.050000   1.300     
1.000   9E7577

11000110 11   Apple, sauce                       0.050000   1.000     
1.000   9E7577

11000111 11   Apple, sauce-babyfood              0.050000   1.000     
1.000   9E7577

01030150 1CD  Arrowroot, flour                   0.050000   1.000     
1.000   9E7577

01030151 1CD  Arrowroot, flour-babyfood          0.050000   1.000     
1.000   9E7577

01030170 1CD  Artichoke, Jerusalem               0.050000   1.000     
1.000   9E7577

95000190 O    Asparagus                          0.800000   1.000     
1.000   1F6229

09020210 9B   Balsam pear                        0.500000   1.000     
1.000   

06030300 6C   Bean, black, seed                  0.050000   1.000     
1.000   

06020310 6B   Bean, broad, succulent             0.050000   1.000     
1.000   9E7577

06030320 6C   Bean, broad, seed                  0.050000   1.000     
1.000   

06020330 6B   Bean, cowpea, succulent            0.050000   1.000     
1.000   9E7577

06030340 6C   Bean, cowpea, seed                 0.050000   1.000     
1.000   

06030350 6C   Bean,  great northern, seed        0.050000   1.000     
1.000   

06030360 6C   Bean, kidney, seed                 0.050000   1.000     
1.000   

06020370 6B   Bean, lima, succulent              0.050000   1.000     
1.000   9E7577

06030380 6C   Bean, lima, seed                   0.050000   1.000     
1.000   

06030390 6C   Bean, mung, seed                   0.050000   1.000     
1.000   

06030400 6C   Bean, navy, seed                   0.050000   1.000     
1.000   

06030410 6C   Bean, pink, seed                   0.050000   1.000     
1.000   

06030420 6C   Bean, pinto, seed                  0.050000   1.000     
1.000   

06010430 6A   Bean, snap, succulent              0.050000   1.000     
1.000   

06010431 6A   Bean, snap, succulent-babyfood     0.050000   1.000     
1.000   

21000460 M    Beef, meat byproducts              0.100000   1.000     
1.000   3F4193

21000461 M    Beef, meat byproducts-babyfood     0.100000   1.000     
1.000   

21000480 M    Beef, kidney                       0.100000   1.000     
1.000   3F4193

21000490 M    Beef, liver                        0.100000   1.000     
1.000   3F4193

21000491 M    Beef, liver-babyfood               0.100000   1.000     
1.000   

13020570 13B  Blueberry                          0.050000   1.000     
1.000   9E7577

13020571 13B  Blueberry-babyfood                 0.050000   1.000     
1.000   9E7577

14000590 14   Brazil nut                         0.050000   1.000     
1.000   8F4937

14000680 14   Butternut                          0.050000   1.000     
1.000   

09010750 9A   Cantaloupe                         0.100000   1.000     
1.000   0E6206

09010800 9A   Casaba                             0.100000   1.000     
1.000   0E6206

14000810 14   Cashew                             0.050000   1.000     
1.000   8F4937

01030820 1CD  Cassava                            0.050000   1.000     
1.000   9E7577

01030821 1CD  Cassava-babyfood                   0.050000   1.000     
1.000   9E7577

09020880 9B   Chayote, fruit                     0.500000   1.000     
1.000   

14000920 14   Chestnut                           0.050000   1.000     
1.000   8F4937

06030980 6C   Chickpea, seed                     0.050000   1.000     
1.000   

06030981 6C   Chickpea, seed-babyfood            0.050000   1.000     
1.000   

06030990 6C   Chickpea, flour                    0.050000   1.000     
1.000   

09021020 9B   Chinese waxgourd                   0.500000   1.000     
1.000   

15001200 15   Corn, field, flour                 0.050000   1.000     
1.000   6F4661

15001201 15   Corn, field, flour-babyfood        0.050000   1.000     
1.000   

15001210 15   Corn, field, meal                  0.050000   1.000     
1.000   6F4661

15001211 15   Corn, field, meal-babyfood         0.050000   1.000     
1.000   

15001220 15   Corn, field, bran                  0.050000   1.000     
1.000   6F4661

15001230 15   Corn, field, starch                0.050000   1.000     
1.000   6F4661

15001231 15   Corn, field, starch-babyfood       0.050000   1.000     
1.000   

15001240 15   Corn, field, syrup                 0.050000   1.500     
1.000   6F4661

15001241 15   Corn, field, syrup-babyfood        0.050000   1.500     
1.000   

15001250 15   Corn, field, oil                   0.050000   1.000     
1.000   6F4661

15001251 15   Corn, field, oil-babyfood          0.050000   1.000     
1.000   

15001260 15   Corn, pop                          0.050000   1.000     
1.000   6F4661

15001270 15   Corn, sweet                        0.050000   1.000     
1.000   6F4661

15001271 15   Corn, sweet-babyfood               0.050000   1.000     
1.000   

95001280 O    Cottonseed, oil                    0.050000   1.000     
1.000   8F4937

95001281 O    Cottonseed, oil-babyfood           0.050000   1.000     
1.000   

09021350 9B   Cucumber                           0.500000   1.000     
1.000   0E6085

13021360 13B  Currant                            0.050000   1.000     
1.000   9E7577

13021370 13B  Currant, dried                     0.050000   1.000     
1.000   9E7577

01031390 1CD  Dasheen, corm                      0.050000   1.000     
1.000   9E7577

08001480 8    Eggplant                           0.050000   1.000     
1.000   

13021490 13B  Elderberry                         0.050000   1.000     
1.000   9E7577

14001550 14   Filbert                            0.050000   1.000     
1.000   8F4937

14001560 14   Filbert, oil                       0.050000   1.000     
1.000   

01031660 1CD  Ginger                             0.050000   1.000     
1.000   9E7577

01031661 1CD  Ginger-babyfood                    0.050000   1.000     
1.000   9E7577

01031670 1CD  Ginger, dried                      0.050000   1.000     
1.000   9E7577

23001700 M    Goat, meat byproducts              0.100000   1.000     
1.000   

23001720 M    Goat, kidney                       0.100000   1.000     
1.000   

23001730 M    Goat, liver                        0.100000   1.000     
1.000   

13021740 13B  Gooseberry                         0.050000   1.000     
1.000   9E7577

06031820 6C   Guar, seed                         0.050000   1.000     
1.000   

06031821 6C   Guar, seed-babyfood                0.050000   1.000     
1.000   

14001850 14   Hickory nut                        0.050000   1.000     
1.000   

09011870 9A   Honeydew melon                     0.100000   1.000     
1.000   0E6206

13021910 13B  Huckleberry                        0.050000   1.000     
1.000   9E7577

14002130 14   Macadamia nut                      0.050000   1.000     
1.000   8F4937

08002340 8    Okra                               0.050000   1.000     
1.000   9E7577

06022550 6B   Pea, succulent                     0.050000   1.000     
1.000   9E7577

06022551 6B   Pea, succulent-babyfood            0.050000   1.000     
1.000   9E7577

06022590 6B   Pea, pigeon, succulent             0.050000   1.000     
1.000   9E7577

14002690 14   Pecan                              0.050000   1.000     
1.000   8F4937

08002700 8    Pepper, bell                       0.050000   1.000     
1.000   

08002701 8    Pepper, bell-babyfood              0.050000   1.000     
1.000   

08002710 8    Pepper, bell, dried                0.050000   1.000     
1.000   

08002711 8    Pepper, bell, dried-babyfood       0.050000   1.000     
1.000   

08002720 8    Pepper, nonbell                    0.050000   1.000     
1.000   

08002721 8    Pepper, nonbell-babyfood           0.050000   1.000     
1.000   

08002730 8    Pepper, nonbell, dried             0.050000   1.000     
1.000   

14002820 14   Pistachio                          0.050000   1.000     
1.000   8F4937

25002920 M    Pork, meat byproducts              0.100000   1.000     
1.000   3F4193

25002921 M    Pork, meat byproducts-babyfood     0.100000   1.000     
1.000   

25002940 M    Pork, kidney                       0.100000   1.000     
1.000   3F4193

25002950 M    Pork, liver                        0.100000   1.000     
1.000   3F4193

01032960 1C   Potato, chips                      0.050000   1.000     
1.000   9E7577

01032970 1C   Potato, dry (granules/ flakes)     0.050000   1.000     
1.000   9E7577

01032971 1C   Potato, dry (granules/ flakes)-b   0.050000   1.000     
1.000   9E7577

01032980 1C   Potato, flour                      0.050000   1.000     
1.000   9E7577

01032981 1C   Potato, flour-babyfood             0.050000   1.000     
1.000   9E7577

01032990 1C   Potato, tuber, w/peel              0.050000   1.000     
1.000   9E7577

01032991 1C   Potato, tuber, w/peel-babyfood     0.050000   1.000     
1.000   9E7577

01033000 1C   Potato, tuber, w/o peel            0.050000   1.000     
1.000   9E7577

01033001 1C   Potato, tuber, w/o peel-babyfood   0.050000   1.000     
1.000   9E7577

09023080 9B   Pumpkin                            0.500000   1.000     
1.000   0E6085

09023090 9B   Pumpkin, seed                      0.500000   1.000     
1.000   

04023220 4B   Rhubarb                            0.050000   1.000     
1.000   9E7577

15003230 15   Rice, white                        0.050000   1.000     
1.000   8F4937

15003231 15   Rice, white-babyfood               0.050000   1.000     
1.000   

15003240 15   Rice, brown                        0.050000   1.000     
1.000   8F4937

15003241 15   Rice, brown-babyfood               0.050000   1.000     
1.000   

15003250 15   Rice, flour                        0.050000   1.000     
1.000   8F4937

15003251 15   Rice, flour-babyfood               0.050000   1.000     
1.000   

15003260 15   Rice, bran                         0.050000   1.000     
1.000   8F4937

15003261 15   Rice, bran-babyfood                0.050000   1.000     
1.000   

26003400 M    Sheep, meat byproducts             0.100000   1.000     
1.000   3F4193

26003420 M    Sheep, kidney                      0.100000   1.000     
1.000   

26003430 M    Sheep, liver                       0.100000   1.000     
1.000   

15003440 15   Sorghum, grain                     0.050000   1.000     
1.000   

15003450 15   Sorghum, syrup                     0.050000   1.000     
1.000   

06003470 6    Soybean, seed                      0.050000   1.000     
1.000   8F7424

06003480 6    Soybean, flour                     0.050000   1.000     
1.000   

06003481 6    Soybean, flour-babyfood            0.050000   1.000     
1.000   

06003490 6    Soybean, soy milk                  0.050000   1.000     
1.000   

06003491 6    Soybean, soy milk-babyfood or in   0.050000   1.000     
1.000   

06003500 6    Soybean, oil                       0.050000   1.000     
1.000   8F7424

06003501 6    Soybean, oil-babyfood              0.050000   1.000     
1.000   

09023560 9B   Squash, summer                     0.500000   1.000     
1.000   0E6085

09023561 9B   Squash, summer-babyfood            0.500000   1.000     
1.000   

09023570 9B   Squash, winter                     0.500000   1.000     
1.000   0E6085

09023571 9B   Squash, winter-babyfood            0.500000   1.000     
1.000   

95003620 O    Sugarcane, sugar                   0.050000   1.000     
1.000   6F4661

95003621 O    Sugarcane, sugar-babyfood          0.050000   1.000     
1.000   

95003630 O    Sugarcane, molasses                0.050000   1.000     
1.000   6F4661

95003631 O    Sugarcane, molasses-babyfood       0.050000   1.000     
1.000   

01033660 1CD  Sweet potato                       0.050000   1.000     
1.000   9E7577

01033661 1CD  Sweet potato-babyfood              0.050000   1.000     
1.000   9E7577

01033710 1CD  Tanier, corm                       0.050000   1.000     
1.000   9E7577

08003740 8    Tomatillo                          0.050000   1.000     
1.000   0F6169

08003750 8    Tomato                             0.050000   1.000     
1.000   0F6169

08003751 8    Tomato-babyfood                    0.050000   1.000     
1.000   

08003760 8    Tomato, paste                      0.050000   1.000     
1.000   0F6169

08003761 8    Tomato, paste-babyfood             0.050000   1.000     
1.000   

08003770 8    Tomato, puree                      0.050000   1.000     
1.000   0F6169

08003771 8    Tomato, puree-babyfood             0.050000   1.000     
1.000   

08003780 8    Tomato, dried                      0.050000  14.300     
1.000   0F6169

08003781 8    Tomato, dried-babyfood             0.050000  14.300     
1.000   

08003790 8    Tomato, juice                      0.050000   1.500     
1.000   0F6169

01033870 1CD  Turmeric                           0.050000   1.000     
1.000   9E7577

14003910 14   Walnut                             0.050000   1.000     
1.000   8F4937

86010000 O    Water, direct, all sources         0.059200   1.000     
1.000   DP#358

  Full comment: DP#358032

86020000 O    Water, indirect, all sources       0.059200   1.000     
1.000   

09013990 9A   Watermelon                         0.100000   1.000     
1.000   

09014000 9A   Watermelon, juice                  0.100000   1.000     
1.000   

15004050 15   Wild rice                          0.050000   1.000     
1.000   8F4937

01034060 1CD  Yam, true                          0.050000   1.000     
1.000   9E7577

01034070 1CD  Yam bean                           0.050000   1.000     
1.000   9E7577

Attachment 2:  Acute Results File

U.S. Environmental Protection Agency                                  

Ver. 2.02 DEEM-FCID ACUTE Analysis for HALOSULFURON-METHYL 

(1994-98 data)

Residue file: acute & chronic 128721.R98          Adjustment factor #2
NOT used.

Analysis Date: 02-17-2010/13:47:27    Residue file dated:
02-17-2010/13:45:22/8

NOEL (Acute) =  50.000000 mg/kg body-wt/day

Daily totals for food and foodform consumption used.

Run Comment: "Acute is only for Females 13-49 yrs"

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

Summary calculations (per capita):

      95th Percentile             99th Percentile             99.9th
Percentile

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

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

Females 13-49 yrs:

  0.003401  0.68    14702    0.005484  1.10     9116     0.008568   1.71
    5835  

U.S. Environmental Protection Agency                                
Ver. 2.00

DEEM-FCID Chronic analysis for HALOSULFURON-METHYL              (1994-98
data)

Residue file name: C:\Documents and
Settings\drate\Desktop\Halosulfuron\DEEM\acute & chronic 128721.R98

                                                 Adjustment factor #2
NOT used.

Analysis Date 02-17-2010/13:46:02     Residue file dated:
02-17-2010/13:45:22/8

Reference dose (RfD, Chronic) = .1 mg/kg bw/day

NOEL (Chronic) = 10 mg/kg bw/day

COMMENT 1: Acute is only for Females 13-49 yrs

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

                    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)                     0.001705        5,865       
1.7%

U.S. Population (spring season)             0.001697        5,892       
1.7%

U.S. Population (summer season)             0.001855        5,390       
1.9%

U.S. Population (autumn season)             0.001643        6,086       
1.6%

U.S. Population (winter season)             0.001620        6,171       
1.6%

Northeast region                            0.001596        6,267       
1.6%

Midwest region                              0.001723        5,805       
1.7%

Southern region                             0.001621        6,168       
1.6%

Western region                              0.001917        5,216       
1.9%

Hispanics                                   0.001924        5,198       
1.9%

Non-hispanic whites                         0.001664        6,010       
1.7%

Non-hispanic blacks                         0.001612        6,204       
1.6%

Non-hisp/non-white/non-black                0.002126        4,704       
2.1%

All infants (< 1 year)                      0.005059        1,977       
5.1%

Nursing infants                             0.002081        4,806       
2.1%

Non-nursing infants                         0.006189        1,616       
6.2%

Children 1-6  yrs                           0.002864        3,491       
2.9%

Children 7-12 yrs                           0.001761        5,677       
1.8%

Females 13-19 (not preg or nursing)         0.001258        7,948       
1.3%

Females 20+ (not preg or nursing)           0.001577        6,341       
1.6%

Females 13-50 yrs                           0.001578        6,338       
1.6%

Females 13+ (preg/not nursing)              0.001599        6,252       
1.6%

Females 13+ (nursing)                       0.002110        4,740       
2.1%

Males 13-19 yrs                             0.001387        7,209       
1.4%

Males 20+ yrs                               0.001467        6,815       
1.5%

Seniors 55+                                 0.001560        6,411       
1.6%

Children 1-2 yrs                            0.003157        3,167       
3.2%

Children 3-5 yrs                            0.002823       
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Adults 50+ yrs                              0.001558        6,420       
1.6%

Females 13-49 yrs                           0.001503        6,655       
1.5%

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

Halosulfuron-methyl	Dietary Exposure and Risk Assessment	DP Number:
367059	

PC Code: 128721		

________________________________________________________________________
______________

Page   PAGE  1  of   NUMPAGES  14 

