
                                       
                 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
                            WASHINGTON, D.C.  20460
                                                                      OFFICE OF
                                                            CHEMICAL SAFETY AND
\* MERGEFORMAT
                                                           POLLUTION PREVENTION


MEMORANDUM

Date:  		03/11/2013

SUBJECT:	Halosulfuron-methyl. Acute and Chronic Aggregate Dietary (Food and Drinking Water) Exposure and Risk Assessments for the Section 3 Registration Action on Artichoke and Caneberry Subgroup 13-07A.

PC Code:  128721
DP Barcode:  D405660
Decision No.:  465913
Registration Nos.:  81880-18 and 81880-2
Petition No.:  2E8050
Regulatory Action:  Section 3 Registration
Risk Assessment Type:  Dietary
Case No.:  NA
TXR No.:  NA
CAS No.:  100784-20-1
MRID No.:  NA
40 CFR:  §180.479

FROM:	Meheret Negussie, Chemist
	Risk Assessment Branch III
            	Health Effects Division (7509P)

THROUGH:	Donna Davis, Chemist
		Ideliz Negron-Encarnacion Ph.D., Chemist 
            Dietary Exposure Science Advisory Council (DESAC)
            Health Effects Division (HED; 7509P)

TO:		Christine Olinger, Branch Chief
      Sheila Healy, Ph.D., Toxicologist/Risk Assessor
		HED/RAB3 (7509P)
				and
      Barbara Madden/Sydney Jackson (RM Team 03)
		Risk Integration Minor Use, and Emergency Response Branch
		Registration Division (7505P)
		


Executive Summary

Acute and chronic aggregate dietary (food and drinking water) exposure and risk assessments were conducted using the Dietary Exposure Evaluation Model software with the Food Commodity Intake Database (DEEM-FCID) Version 3.16.  This software uses 2003-2008 food consumption data from the U.S. Department of Agriculture's (USDA's) National Health and Nutrition Examination Survey, What We Eat in America, (NHANES/WWEIA).  The analyses were conducted to support a human health risk assessment for the proposed Section 3 requests on artichoke and caneberry Subgroup 13-07A.  This memorandum was reviewed by two peer reviewers of the DESAC, per DESAC SOP 2012.1. 
     
Acute and Chronic Dietary (Food and Drinking Water) Exposure Results and Characterization

Acute and chronic dietary (food and drinking water) exposure assessments were conducted for the current uses, and proposed new uses on artichoke and caneberry Subgroup 13-07A.  The assumptions of the dietary assessments included tolerance-level residues for all commodities and 100 % crop treated (CT) for all crops.  DEEM version 7.81 default processing factors were assumed except for where tolerances were established for processed commodities or when processing studies showed no concentration.  Modeled estimated drinking water concentrations were included in the assessment

There was no indication of an adverse effect attributable to a single dose for the general U.S. population.  However, an acute reference dose (aRfD) was established for females 13-49 years old, and an acute dietary exposure assessment was only conducted for females 13-49 years old.   
The acute dietary exposure estimate at the 95[th] percentile is <1% of the acute population adjusted dose (aPAD) for females 13-49 years old.

The chronic dietary (food and drinking water) exposure to halosulfuron-methyl is below HED's level of concern (<100% of the chronic population adjusted dose (cPAD)) for the general U.S. population and all population subgroups.  The chronic dietary exposure estimates are 2.0% of the cPAD for the general U.S. population and 5.5% of the cPAD for children 1-2 year old, the most highly exposed population subgroup.

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

Halosulfuron-methyl is classified 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 the 


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

For acute and non-cancer chronic exposures, HED is concerned when estimated dietary risk exceeds 100% of the PAD.  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:  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 Cassi Walls (D396459, 07/12/2012).

II.	Residue Information

The Interregional Research Project No. 4 (IR-4) has proposed new uses of halosulfuron-methyl on artichoke and caneberry Subgroup 13-07A.  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, at levels ranging from 0.05 ppm (milk, fat and meat) to 1.0 ppm (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.  

The Metabolism Committee has concluded that the residue of concern for tolerance enforcement and risk assessment in target plants and rotational plants is halosulfuron-methyl (G. J. Herndon, No DP#s, 9/16/1993 and 5/21/1996).  

HED previously has concluded that the residue of concern in ruminants is halosulfuron-methyl. However, because the approved enforcement method for livestock commodities quantifies the parent compound and metabolites containing the 3-CSA moiety by converting residues to 3-CSA, tolerances for residues of parent and its metabolites in livestock commodities are determined as 3-CSA, expressed in halosulfuron-methyl equivalents.  

The residue of concern in water is halosulfuron-methyl.  

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.  Additionally, DEEM version 7.81 default processing factors were assumed except for where tolerances were established for processed commodities or when processing studies showed no concentration.  Based on processing studies, the processing factors for tomato paste, tomato puree, potato flour and potato granules/flakes were reduced to 1.   



Table 1 is a summary of the HED recommended food tolerances resulting from the proposed uses (D405659, L. Cheng, 11/26/2012). 

Table 1.    Tolerance Summary for the New Uses for Halosulfuron-Methyl.
Commodity 
                            Recommended Tolerances 
                                 Used in the 
                          Acute and Chronic Analyses
                                     (ppm)
Artichoke 
                                     0.05
Caneberry Subgroup 13-07A
                                     0.05

   Drinking Water Data (We didn't receive the water memo, but EFED communicated (email) that there is no change.  

The drinking water residues used in the acute dietary risk assessment were provided by EFED in the following memorandum: "Halosulfuron methyl Drinking Water Assessment for Additional Food/Feed Uses on Proso Millet, Pasture and Rangeland Grass Forage, Fodder and Hay (Crop Group 17)" (D394244, J. Meléndez, 5/15/2012) 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 acute drinking water assessment was not required for the acute dietary assessment (personal communication via email from Jose Melendez to Meheret Neghussie, date).    

Monitoring data is not available for halosulfuron-methyl; therefore estimated drinking water concentrations (EDWCs) were derived from models.     

Acute Tier I EDWCs for halosulfuron-methyl were 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.  This value was used for the acute dietary assessment only.   HED notes that this drinking water value is considered to be highly conservative and reflects a calculated concentration of residue in a shallow farm pond based on the maximum application rate on the label.  HED considers this value appropriate as a screening level assessment for potential acute exposure and since the calculated concentration does not pose a risk of concern, further refinement is not required.  
  
The estimate for halosulfuron-methyl in groundwater based on the SCI-GROW model result is 0.065 ppb.  Table 2 summarizes the results.


 




Table 2.  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. 

IV.	DEEM-FCID(TM) Program and Consumption Information

Halosulfuron-methyl acute and chronic dietary exposure assessments were conducted using the DEEM-FCID, Version 3.16, which incorporates 2003-2008 consumption data from USDA's NHANES/WWEIA.  The data are based on the reported consumption of more than 20,000 individuals over two non-consecutive survey days.  Foods "as consumed" (e.g., apple pie) are linked to EPA-defined food commodities (e.g., apples, peeled fruit - cooked; fresh or N/S; baked; or wheat flour - cooked; fresh or N/S, baked) using publicly available recipe translation files developed jointly by USDA/ARS and EPA.  For chronic exposure assessment, consumption data are averaged for the entire U.S. population and within population subgroups.  However, for acute exposure assessment, consumption data are retained as individual consumption events.  Based on analysis of the 2003-2008 WWEIA consumption data, which took into account dietary patterns and survey respondents, HED concluded that it is most appropriate to report risk 

for the following population subgroups: the general U.S. population, all infants (<1 year old), children 1-2, children 3-5, children 6-12, youth 13-19, adults 20-49, females 13-49, and adults 50-99 years old.

For 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.

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 (D358031, W. Phang, 06/30/2009).  



Toxicological endpoints for use in dietary exposure risk assessments are summarized in Table 3 below. 

Table 3.  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 effect seen in the database that is likely the result of a single exposure; therefore, no 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, HED 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 acute dietary (food and drinking water) exposure to halosulfuron-methyl is below HED's level of concern.  The acute dietary exposure estimate at the 95[th] 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 chronic dietary (food and drinking water) exposure to halosulfuron-methyl is below HED's level of concern for the general U.S. population and all population subgroups.  The chronic dietary exposure estimates are 2.0% of the cPAD for the general U.S. population and 5.5% of the cPAD for children 1-2 year olds, 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
                                    0.002050
                                      2.0
 All Infants (< 1 year old)
                                        
                                        
                                    0.004871
                                      4.9
 Children 1-2 years old
                                        
                                        
                                    0.005508
                                      5.5
 Children 3-5 years old
                                        
                                        
                                    0.003884
                                      3.9
 Children 6-12 years old
                                        
                                        
                                    0.002433
                                      2.4
 Youth 13-19 years old
                                        
                                        
                                    0.001579
                                      1.6
 Adults 20-49 years old
                                        
                                        
                                    0.001791
                                      1.8
 Adults 50+ years old
                                        
                                        
                                    0.001737
                                      1.7
 Females 13-49 years old
                                    0.003733
                                     <1
                                    0.001785
                                      1.8
The population subgroup with the highest estimated exposure/risk is bolded.

VII.	Characterization of Inputs/Outputs

The acute and chronic assessments are considered to be highly conservative and health protective.  The residue levels used in the assessments for all commodities were the established or recommended tolerance levels.  The assessments were conducted using the assumption that 100% of the crop was treated.  Default (DEEM 7.81) processing factors were used unless processing studies were available (tomato and potato) and modeled estimated drinking water concentrations were included in the assessments.  

These assessments could be refined, which would likely significantly decrease the estimated risk, with percent crop treated estimates, anticipated residues, or monitoring data.  Since risk estimates are well below HED's level of concern, a more highly refined analysis is not needed at this time.
 
 
 
 
 
VIII.	Conclusions

Acute and chronic dietary exposure assessments were conducted for the proposed uses on artichoke and caneberry subgroup 13-07A.  The analyses were unrefined assessments, using tolerances for all commodities, the assumption of 100% CT, default (DEEM 7.81) processing factors when appropriate, and modeled water numbers.  

 For both of the acute and chronic assessments, assessments for all populations of concern have risk estimates which are below HED's level of concern.  HED is confident that the acute and chronic assessments do not underestimate risk to the general U.S. population or any population subgroup.  
 
 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








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

Filename: C:\Documents and Settings\MNEGUSSI\My Documents\DEEM Version 3.16\Halosulfuron-methyl\ACUTE & CHRONIC 022713.R08
Chemical: halosulfuron-methyl
RfD(Chronic): .1 mg/kg bw/day  NOEL(Chronic): 10 mg/kg bw/day
RfD(Acute): .5 mg/kg bw/day  NOEL(Acute):  50 mg/kg bw/day
Date created/last modified: 02-27-2013/14:16:43       Program ver. 3.16, 03-08-d
Comment: Acute is only for Females 13-49 yrs; New Uses Artichoke and Caneberry sugroup 13-07A
-----------------------------------------------------------------------------------
   EPA     Crop                                   Def Res     Adj.Factors   Comment
   Code     Grp  Commodity Name                    (ppm)       #1    #2   
---------- ---- -------------------------------  ----------  ------ ------  -------
0103015000 1CD  Arrowroot, flour                   0.050000   1.000  1.000  9E7577
0103015001 1CD  Arrowroot, flour-babyfood          0.050000   1.000  1.000  9E7577
0103017000 1CD  Artichoke, Jerusalem               0.050000   1.000  1.000  9E7577
0103082000 1CD  Cassava                            0.050000   1.000  1.000  9E7577
0103082001 1CD  Cassava-babyfood                   0.050000   1.000  1.000  9E7577
0103139000 1CD  Dasheen, corm                      0.050000   1.000  1.000  9E7577
0103166000 1CD  Ginger                             0.050000   1.000  1.000  9E7577
0103166001 1CD  Ginger-babyfood                    0.050000   1.000  1.000  9E7577
0103167000 1CD  Ginger, dried                      0.050000   1.000  1.000  9E7577
0103296000 1C   Potato, chips                      0.050000   1.000  1.000  9E7577
0103297000 1C   Potato, dry (granules/ flakes)     0.050000   1.000  1.000  9E7577
0103297001 1C   Potato, dry (granules/ flakes)-b   0.050000   1.000  1.000  9E7577
0103298000 1C   Potato, flour                      0.050000   1.000  1.000  9E7577
0103298001 1C   Potato, flour-babyfood             0.050000   1.000  1.000  9E7577
0103299000 1C   Potato, tuber, w/peel              0.050000   1.000  1.000  9E7577
0103299001 1C   Potato, tuber, w/peel-babyfood     0.050000   1.000  1.000  9E7577
0103300000 1C   Potato, tuber, w/o peel            0.050000   1.000  1.000  9E7577
0103300001 1C   Potato, tuber, w/o peel-babyfood   0.050000   1.000  1.000  9E7577
0103366000 1CD  Sweet potato                       0.050000   1.000  1.000  9E7577
0103366001 1CD  Sweet potato-babyfood              0.050000   1.000  1.000  9E7577
0103371000 1CD  Tanier, corm                       0.050000   1.000  1.000  9E7577
0103387000 1CD  Turmeric                           0.050000   1.000  1.000  9E7577
0103406000 1CD  Yam, true                          0.050000   1.000  1.000  9E7577
0103407000 1CD  Yam bean                           0.050000   1.000  1.000  9E7577
0402322000 4B   Rhubarb                            0.050000   1.000  1.000  9E7577
0600347000 6    Soybean, seed                      0.050000   1.000  1.000  8F7424
0600349000 6    Soybean, soy milk                  0.050000   1.000  1.000  
0600349001 6    Soybean, soy milk-babyfood or in   0.050000   1.000  1.000  
0600350000 6    Soybean, oil                       0.050000   1.000  1.000  8F7424
0600350001 6    Soybean, oil-babyfood              0.050000   1.000  1.000  
0601043000 6A   Bean, snap, succulent              0.050000   1.000  1.000  
0601043001 6A   Bean, snap, succulent-babyfood     0.050000   1.000  1.000  
0602031000 6B   Bean, broad, succulent             0.050000   1.000  1.000  9E7577
0602033000 6B   Bean, cowpea, succulent            0.050000   1.000  1.000  9E7577
0602037000 6B   Bean, lima, succulent              0.050000   1.000  1.000  9E7577
0602255000 6B   Pea, succulent                     0.050000   1.000  1.000  9E7577
0602255001 6B   Pea, succulent-babyfood            0.050000   1.000  1.000  9E7577
0602259000 6B   Pea, pigeon, succulent             0.050000   1.000  1.000  9E7577
0603030000 6C   Bean, black, seed                  0.050000   1.000  1.000  
0603032000 6C   Bean, broad, seed                  0.050000   1.000  1.000  
0603034000 6C   Bean, cowpea, seed                 0.050000   1.000  1.000  
0603035000 6C   Bean,  great northern, seed        0.050000   1.000  1.000  
0603036000 6C   Bean, kidney, seed                 0.050000   1.000  1.000  
0603038000 6C   Bean, lima, seed                   0.050000   1.000  1.000  
0603039000 6C   Bean, mung, seed                   0.050000   1.000  1.000  
0603040000 6C   Bean, navy, seed                   0.050000   1.000  1.000  
0603041000 6C   Bean, pink, seed                   0.050000   1.000  1.000  
0603042000 6C   Bean, pinto, seed                  0.050000   1.000  1.000  
0603098000 6C   Chickpea, seed                     0.050000   1.000  1.000  
0603098001 6C   Chickpea, seed-babyfood            0.050000   1.000  1.000  
0603099000 6C   Chickpea, flour                    0.050000   1.000  1.000  
0603182000 6C   Guar, seed                         0.050000   1.000  1.000  
0603182001 6C   Guar, seed-babyfood                0.050000   1.000  1.000  
0603348000 6C   Soybean, flour                     0.050000   1.000  1.000  
0603348001 6C   Soybean, flour-babyfood            0.050000   1.000  1.000  
0801374000 8A   Tomatillo                          0.050000   1.000  1.000  0F6169
0801375000 8A   Tomato                             0.050000   1.000  1.000  0F6169
0801375001 8A   Tomato-babyfood                    0.050000   1.000  1.000  
0801376000 8A   Tomato, paste                      0.050000   1.000  1.000  0F6169
0801376001 8A   Tomato, paste-babyfood             0.050000   1.000  1.000  
0801377000 8A   Tomato, puree                      0.050000   1.000  1.000  0F6169
0801377001 8A   Tomato, puree-babyfood             0.050000   1.000  1.000  
0801378000 8A   Tomato, dried                      0.050000  14.300  1.000  0F6169
0801378001 8A   Tomato, dried-babyfood             0.050000  14.300  1.000  
0801379000 8A   Tomato, juice                      0.050000   1.500  1.000  0F6169
0802148000 8BC  Eggplant                           0.050000   1.000  1.000  
0802234000 8BC  Okra                               0.050000   1.000  1.000  9E7577
0802270000 8B   Pepper, bell                       0.050000   1.000  1.000  
0802270001 8B   Pepper, bell-babyfood              0.050000   1.000  1.000  
0802271000 8B   Pepper, bell, dried                0.050000   1.000  1.000  
0802271001 8B   Pepper, bell, dried-babyfood       0.050000   1.000  1.000  
0802272000 8BC  Pepper, nonbell                    0.050000   1.000  1.000  
0802272001 8BC  Pepper, nonbell-babyfood           0.050000   1.000  1.000  
0802273000 8BC  Pepper, nonbell, dried             0.050000   1.000  1.000  
0901075000 9A   Cantaloupe                         0.100000   1.000  1.000  0E6206
0901187000 9A   Honeydew melon                     0.100000   1.000  1.000  0E6206
0901399000 9A   Watermelon                         0.100000   1.000  1.000  
0901400000 9A   Watermelon, juice                  0.100000   1.000  1.000  
0902021000 9B   Balsam pear                        0.500000   1.000  1.000  
0902088000 9B   Chayote, fruit                     0.500000   1.000  1.000  
0902102000 9B   Chinese waxgourd                   0.500000   1.000  1.000  
0902135000 9B   Cucumber                           0.500000   1.000  1.000  0E6085
0902308000 9B   Pumpkin                            0.500000   1.000  1.000  0E6085
0902309000 9B   Pumpkin, seed                      0.500000   1.000  1.000  
0902356000 9B   Squash, summer                     0.500000   1.000  1.000  0E6085
0902356001 9B   Squash, summer-babyfood            0.500000   1.000  1.000  
0902357000 9B   Squash, winter                     0.500000   1.000  1.000  0E6085
0902357001 9B   Squash, winter-babyfood            0.500000   1.000  1.000  
1100007000 11   Apple, fruit with peel             0.050000   1.000  1.000  9E7577
1100008000 11   Apple, peeled fruit                0.050000   1.000  1.000  9E7577
1100008001 11   Apple, peeled fruit-babyfood       0.050000   1.000  1.000  9E7577
1100009000 11   Apple, dried                       0.050000   8.000  1.000  9E7577
1100009001 11   Apple, dried-babyfood              0.050000   8.000  1.000  9E7577
1100010000 11   Apple, juice                       0.050000   1.300  1.000  9E7577
1100010001 11   Apple, juice-babyfood              0.050000   1.300  1.000  9E7577
1100011000 11   Apple, sauce                       0.050000   1.000  1.000  9E7577
1100011001 11   Apple, sauce-babyfood              0.050000   1.000  1.000  9E7577
1301055000 13A  Blackberry                         0.050000   1.000  1.000  DP# D4
            Full comment: DP# D405659
1301056000 13A  Blackberry, juice                  0.050000   1.000  1.000  DP# D4
            Full comment: DP# D405659
1301056001 13A  Blackberry, juice-babyfood         0.050000   1.000  1.000  DP# D4
            Full comment: DP# D405659
1301058000 13A  Boysenberry                        0.050000   1.000  1.000  DP# D4
            Full comment: DP# D405659
1301208000 13A  Loganberry                         0.050000   1.000  1.000  DP# D4
            Full comment: DP# D405659
1301320000 13A  Raspberry                          0.050000   1.000  1.000  DP# D4
            Full comment: DP# D405659
1301321000 13A  Raspberry, juice                   0.050000   1.000  1.000  DP# D4
            Full comment: DP# D405659
1302057000 13B  Blueberry                          0.050000   1.000  1.000  9E7577
1302057001 13B  Blueberry-babyfood                 0.050000   1.000  1.000  9E7577
1302136000 13B  Currant                            0.050000   1.000  1.000  9E7577
1302137000 13B  Currant, dried                     0.050000   1.000  1.000  9E7577
1302149000 13B  Elderberry                         0.050000   1.000  1.000  9E7577
1302174000 13B  Gooseberry                         0.050000   1.000  1.000  9E7577
1302191000 13B  Huckleberry                        0.050000   1.000  1.000  9E7577
1400003000 14   Almond                             0.050000   1.000  1.000  8F4937
1400003001 14   Almond-babyfood                    0.050000   1.000  1.000  
1400004000 14   Almond, oil                        0.050000   1.000  1.000  8F4937
1400004001 14   Almond, oil-babyfood               0.050000   1.000  1.000  
1400059000 14   Brazil nut                         0.050000   1.000  1.000  8F4937
1400068000 14   Butternut                          0.050000   1.000  1.000  
1400081000 14   Cashew                             0.050000   1.000  1.000  8F4937
1400092000 14   Chestnut                           0.050000   1.000  1.000  8F4937
1400155000 14   Hazelnut                           0.050000   1.000  1.000  8F4937
1400156000 14   Hazelnut, oil                      0.050000   1.000  1.000  
1400185000 14   Hickory nut                        0.050000   1.000  1.000  
1400213000 14   Macadamia nut                      0.050000   1.000  1.000  8F4937
1400269000 14   Pecan                              0.050000   1.000  1.000  8F4937
1400282000 14   Pistachio                          0.050000   1.000  1.000  8F4937
1400391000 14   Walnut                             0.050000   1.000  1.000  8F4937
1500120000 15   Corn, field, flour                 0.050000   1.000  1.000  6F4661
1500120001 15   Corn, field, flour-babyfood        0.050000   1.000  1.000  
1500121000 15   Corn, field, meal                  0.050000   1.000  1.000  6F4661
1500121001 15   Corn, field, meal-babyfood         0.050000   1.000  1.000  
1500122000 15   Corn, field, bran                  0.050000   1.000  1.000  6F4661
1500123000 15   Corn, field, starch                0.050000   1.000  1.000  6F4661
1500123001 15   Corn, field, starch-babyfood       0.050000   1.000  1.000  
1500124000 15   Corn, field, syrup                 0.050000   1.500  1.000  6F4661
1500124001 15   Corn, field, syrup-babyfood        0.050000   1.500  1.000  
1500125000 15   Corn, field, oil                   0.050000   1.000  1.000  6F4661
1500125001 15   Corn, field, oil-babyfood          0.050000   1.000  1.000  
1500126000 15   Corn, pop                          0.050000   1.000  1.000  6F4661
1500127000 15   Corn, sweet                        0.050000   1.000  1.000  6F4661
1500127001 15   Corn, sweet-babyfood               0.050000   1.000  1.000  
1500226000 15   Millet, grain                      0.010000   1.000  1.000  
1500323000 15   Rice, white                        0.050000   1.000  1.000  8F4937
1500323001 15   Rice, white-babyfood               0.050000   1.000  1.000  
1500324000 15   Rice, brown                        0.050000   1.000  1.000  8F4937
1500324001 15   Rice, brown-babyfood               0.050000   1.000  1.000  
1500325000 15   Rice, flour                        0.050000   1.000  1.000  8F4937
1500325001 15   Rice, flour-babyfood               0.050000   1.000  1.000  
1500326000 15   Rice, bran                         0.050000   1.000  1.000  8F4937
1500326001 15   Rice, bran-babyfood                0.050000   1.000  1.000  
1500344000 15   Sorghum, grain                     0.050000   1.000  1.000  
1500345000 15   Sorghum, syrup                     0.050000   1.000  1.000  
1500405000 15   Wild rice                          0.050000   1.000  1.000  8F4937
2003128000 20C  Cottonseed, oil                    0.050000   1.000  1.000  8F4937
2003128001 20C  Cottonseed, oil-babyfood           0.050000   1.000  1.000  
3100044000 31   Beef, meat                         0.050000   1.000  1.000  
3100044001 31   Beef, meat-babyfood                0.050000   1.000  1.000  
3100045000 31   Beef, meat, dried                  0.050000   1.900  1.000  
3100046000 31   Beef, meat byproducts              1.000000   1.000  1.000  
3100046001 31   Beef, meat byproducts-babyfood     1.000000   1.000  1.000  
3100047000 31   Beef, fat                          0.050000   1.000  1.000  
3100047001 31   Beef, fat-babyfood                 0.050000   1.000  1.000  
3100048000 31   Beef, kidney                       1.000000   1.000  1.000  
3100049000 31   Beef, liver                        1.000000   1.000  1.000  
3100049001 31   Beef, liver-babyfood               1.000000   1.000  1.000  
3200169000 32   Goat, meat                         0.050000   1.000  1.000  
3200170000 32   Goat, meat byproducts              1.000000   1.000  1.000  
3200171000 32   Goat, fat                          0.050000   1.000  1.000  
3200172000 32   Goat, kidney                       1.000000   1.000  1.000  
3200173000 32   Goat, liver                        1.000000   1.000  1.000  
3300189000 33   Horse, meat                        0.050000   1.000  1.000  
3400292000 34   Pork, meat byproducts              0.100000   1.000  1.000  3F4193
3400292001 34   Pork, meat byproducts-babyfood     0.100000   1.000  1.000  
3400294000 34   Pork, kidney                       0.100000   1.000  1.000  3F4193
3400295000 34   Pork, liver                        0.100000   1.000  1.000  3F4193
3500339000 35   Sheep, meat                        0.050000   1.000  1.000  
3500339001 35   Sheep, meat-babyfood               0.050000   1.000  1.000  
3500340000 35   Sheep, meat byproducts             1.000000   1.000  1.000  
3500341000 35   Sheep, fat                         0.050000   1.000  1.000  
3500341001 35   Sheep, fat-babyfood                0.050000   1.000  1.000  
3500342000 35   Sheep, kidney                      1.000000   1.000  1.000  
3500343000 35   Sheep, liver                       1.000000   1.000  1.000  
3600222000 36   Milk, fat                          0.050000   1.000  1.000  
3600222001 36   Milk, fat-baby food/infant formu   0.050000   1.000  1.000  
3600223000 36   Milk, nonfat solids                0.050000   1.000  1.000  
3600223001 36   Milk, nonfat solids-baby food/in   0.050000   1.000  1.000  
3600224000 36   Milk, water                        0.050000   1.000  1.000  
3600224001 36   Milk, water-babyfood/infant form   0.050000   1.000  1.000  
3600225001 36   Milk, sugar (lactose)-baby food/   0.050000   1.000  1.000  
8601000000 86A  Water, direct, all sources         0.059200   1.000  1.000  DP#358
            Full comment: DP#358032
8602000000 86B  Water, indirect, all sources       0.059200   1.000  1.000  
9500016000 O    Artichoke, globe                   0.050000   1.000  1.000  
9500019000 O    Asparagus                          0.800000   1.000  1.000  1F6229
9500362000 O    Sugarcane, sugar                   0.050000   1.000  1.000  6F4661
9500362001 O    Sugarcane, sugar-babyfood          0.050000   1.000  1.000  
9500363000 O    Sugarcane, molasses                0.050000   1.000  1.000  6F4661
9500363001 O    Sugarcane, molasses-babyfood       0.050000   1.000  1.000  


































Attachment 2:  Acute Results File.

U.S. EPA                                                    Ver. 3.16, 03-08-d
DEEM-FCID ACUTE Analysis for HALOSULFURON-METHYL         NHANES 2003-2008 2-Day
Residue file: ACUTE & CHRONIC 022713.R08          Adjustment factor #2 NOT used.
Analysis Date: 02-27-2013/14:18:43    Residue file dated: 02-27-2013/14:16:43
NOEL (Acute) =  50.000000 mg/kg body-wt/day
RAC/FF intake summed over 24 hours
Run Comment: "Acute is only for Females 13-49 yrs; New Uses Artichoke and Cane
berry sugroup 13-07A"
===============================================================================

Summary calculations--per capita:

---   95th Percentile----   ---   99th Percentile----     ---99.9th Percentile----
 Exposure  % aRfD     MOE    Exposure  % aRfD     MOE    Exposure  % aRfD     MOE  
---------- ------- -------- ---------- ------- -------- ---------- ------- --------
Female 13-49:
  0.004091    0.82   12221    0.005756    1.15    8686    0.008278    1.66    6040  















































Attachment 3:  Chronic Results File.

U.S. EPA                                                        Ver. 3.16, 03-08-d
DEEM-FCID Chronic analysis for HALOSULFURON-METHYL         NHANES 2003-2008 2-day
Residue file name: C:\Documents and Settings\MNEGUSSI\My Documents\DEEM Version 3.16\Halosulfuron-methyl\ACUTE & CHRONIC 022713.R08
                                                 Adjustment factor #2 NOT used.
Analysis Date 02-27-2013/14:29:21     Residue file dated: 02-27-2013/14:16:43
Reference dose (RfD, Chronic) = .1 mg/kg bw/day
COMMENT 1: Acute is only for Females 13-49 yrs; New Uses Artichoke and Caneberry sugroup 13-07A
===============================================================================
                    Total exposure by population subgroup
-------------------------------------------------------------------------------

                                                    Total Exposure
                                         -----------------------------------
          Population                         mg/kg             Percent of   
           Subgroup                       body wt/day             Rfd       
--------------------------------------   -------------       ----------------
Total US Population                         0.002050                 2.0%
Hispanic                                    0.002153                 2.2%
Non-Hisp-White                              0.002066                 2.1%
Non-Hisp-Black                              0.001733                 1.7%
Non-Hisp-Other                              0.002316                 2.3%
Nursing Infants                             0.002051                 2.1%
Non-Nursing Infants                         0.006130                 6.1%
Female 13+ PREG                             0.001882                 1.9%
Children 1-6                                0.004358                 4.4%
Children 7-12                               0.002285                 2.3%
Male 13-19                                  0.001591                 1.6%
Female 13-19/NP                             0.001566                 1.6%
Male 20+                                    0.001700                 1.7%
Female 20+/NP                               0.001826                 1.8%
Seniors 55+                                 0.001718                 1.7%
All Infants                                 0.004871                 4.9%
Female 13-50                                0.001784                 1.8%
Children 1-2                                0.005508                 5.5%
Children 3-5                                0.003884                 3.9%
Children 6-12                               0.002433                 2.4%
Youth 13-19                                 0.001579                 1.6%
Adults 20-49                                0.001791                 1.8%
Adults 50-99                                0.001737                 1.7%
Female 13-49                                0.001785                 1.8%



