Document ID: EPA-HQ-OPP-2012-0010-0005
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2012-12-21T05:00Z

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
                            WASHINGTON, D.C.  20460

                                                      OFFICE OF CHEMICAL SAFETY
                                                      AND POLLUTION PREVENTION 

MEMORANDUM

DATE:  	September 24, 2012

SUBJECT:	Quinclorac and the Dimethylamine (DMA) Salt of Quinclorac.  Acute and Chronic Aggregate Dietary (Food and Drinking Water) Exposure and Risk Assessments for the Section 3 Registration Action on Rhubarb and Low Growing Berry except Strawberry, Subgroup 13-07H and the Registration Review Action.  

PC Code:  128974 and 028974
DP Barcodes: D404795 and D404914
Decision Numbers:  459055 and 468877
Registration Number:  42750-169
Petition Number:  1E7957
Regulatory Action:  Section 3 and Registration Review
Assessment Type:  Single Chemical/Aggregate
Case Number:  7222
TXR Number:  Not Applicable
CAS Number:  84087-01-4
MRID Number:  Not Applicable
40CFR §180. 463

FROM:	Bonnie Cropp-Kohlligian, Environmental Scientist
            Risk Assessment Branch IV, Health Effects Division (HED) (7509P)

THROUGH:	Thurston Morton, Chemist, Senior Scientist 
		Risk Assessment Branch IV, HED (7509P)
			and
		Douglas Dotson, Ph.D., Chemist
		Ideliz Negrón-Encarnación, Ph.D., Chemist
            Dietary Exposure Science Advisory Council (DESAC), HED (7509P)
            
TO:		Sidney Jackson and Barbara Madden, PM#5
	        	RIMUERB, Registration Division (RD) (7505P)
			and
	        	Erik Kraft and Kable Davis, PM#25
	        	Herbicide Branch, RD (7505P)
			and
		Wilhelmina Livingston, RM#60
		Pesticide Reevaluation Division (PRD) (7508P)
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 3.16 which uses food consumption data from the U.S. Department of Agriculture's National Health and Nutrition Examination Survey, What We Eat in America, (NHANES/WWEIA).  This dietary survey was conducted from 2003 to 2008.  These analyses were performed to support the Section 3 request for quinclorac uses on rhubarb and low growing berry, except strawberry, subgroup 13-07H and to support Registration Review for quinclorac and the dimethylamine (DMA) salt of quinclorac.  All registered, pending and proposed uses of quinclorac and the DMA salt of quinclorac, as of the date of this memorandum, are included in these assessments.  
	
Tolerances have been established for quinclorac (40CFR §180.463[a]) in livestock and cereal grain commodities.  HED has determined that the use of the DMA salt of quinclorac on cereal grains will not affect the established tolerances for quinclorac on rice, grain sorghum, and wheat.
The residue of concern (ROC), for both tolerance enforcement and risk assessment, is the parent compound, quinclorac.  Both the acute and chronic assessments are highly conservative, and assume 100% crop treated (%CT), along with tolerance-level residues for all agricultural commodities.  Default processing factors from DEEM 7.81 were used (for dried beef and cranberry juice) in the analyses.  Screening-level Tier I modeling was used to estimate drinking water concentrations.

The acute (food + water) dietary risk estimate at the 95[th] percentile of exposure is 1.6% of the acute population adjusted dose (aPAD) for females age 13 to 49.  This is the only population subgroup for which an acute endpoint was selected.  
	
The chronic (food + water) dietary risk estimates are less than or equal to 8.9% of the chronic population adjusted dose (cPAD) for all population subgroups.  All Infants < 1 year of age is the most highly-exposed subgroup, utilizing 8.9% of the cPAD, while the general US population utilizes 3.6% of the cPAD.  

Generally, the Agency is concerned when risk estimates exceed 100% of the PAD.  All acute and chronic dietary risk estimates for quinclorac are below HED's level of concern.  
  
Quinclorac was classified in 1992 by the HED Cancer Peer Review committee (CPRC) as a group D carcinogen - not classifiable as to human carcinogenicity- based on recommendation by the EPA Scientific Advisory Panel (TXR# 0010416).  This classification was based on equivocal increase in the incidence of one type of benign tumor (pancreatic acinar cell adenomas) in only one sex and one species of animals (male Wistar rats).   A quantification of cancer risk is not warranted because the chronic RfD will adequately account for all chronic effects, including the observed adenomas, likely to result from exposure to quinclorac.  

1.	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:  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 quinclorac was conducted by W. Drew (6/2/09, DP# 363872).

2.	Residue Information

Reference Memo:  DP#s 397719, 404569, 404569; 9/6/12; S. Hummel (Residue Chemistry Summary Document)
Reference:  Quinclorac Summary Document Registration Review: Initial Docket December 2007 (bioaccumulation)
	
The qualitative nature of quinclorac residues in plants is considered adequately understood for the currently registered and proposed uses, based on rice, grain sorghum, and wheat metabolism studies.  The qualitative nature of quinclorac residues in livestock is considered adequately understood based on goat and poultry metabolism studies.  In each of these studies, quinclorac was the major residue identified in each commodity.  Based on the above studies, HED has concluded that parent is the only residue of concern in plant and livestock commodities for purposes of the tolerance expression and risk assessment.  

Permanent tolerances have been established for quinclorac (40CFR §180.463[a]) in/on livestock and cereal grain commodities.  A time-limited tolerance for a Section 18 emergency exemption has been established for quinclorac (40CFR §180.463[b]) in/in cranberry at 15.0 ppm (expiration/revocation date 12/31/12).  

Based on rice, grain sorghum, and wheat side-by-side field trial data comparing residue levels of quinclorac and the dimethylamine (DMA) salt of quinclorac and a comparative study of the dissociation behavior of quinclorac and the DMA salt of quinclorac, HED determined that the use of the DMA salt of quinclorac on cereal grains will not affect the established tolerances for quinclorac on rice, grain sorghum, and wheat (DP#s 378709 and 378710, J. Stokes, 3/25/11).
Under PP#1E7957, Interregional Research Project Number 4 (IR-4) is proposing new uses for quinclorac on rhubarb and low growing berry, except strawberry, crop subgroup 13-07H.  In conjunction with these uses, HED is recommending the tolerances below for residues of quinclorac, including its metabolites and degradates.  

      Rhubarb	0.5 ppm
      Low growing berry, except strawberry, crop subgroup 13-07H	1.5 ppm
      
Cranberry is the representative commodity for low growing berry, except strawberry, crop subgroup 13-07H.  Since the proposed Section 3 use on low growing berry, except strawberry, crop subgroup 13-07H is essentially the same as the Section 18 use on cranberry, HED is recommending for the revocation of the currently established time-limited tolerance for residues of quinclorac in/on cranberry (15.0 ppm).  

Under Registration Review of currently registered uses of quinclorac and the DMA salt of quinclorac, HED is recommending no changes to the currently established tolerances in/on the food commodities below for residues of quinclorac, including its metabolites and degradates. 

      Barley, grain	2.0 ppm
      Rice, bran	15.0 ppm
      Rice, grain	5.0 ppm
      Sorghum, grain, grain	6.0 ppm
      Wheat, germ	0.75 ppm
      Wheat, grain	0.5 ppm
      Egg	0.05 ppm
      Fat of Cattle, Goat, Horse, Sheep	0.7 ppm
      Fat of Poultry	0.05 ppm
      Meat of Cattle, Goat, Hog, Horse, Poultry, Sheep	0.05 ppm
      Meat byproducts of Cattle, Goat, Horse, Sheep	1.5 ppm
      Milk	0.05 ppm

Under Registration Review of currently registered uses of quinclorac and the DMA salt of quinclorac, HED is recommending lowering the currently established tolerances in/on the food commodities below for residues of quinclorac, including its metabolites and degradates for the purposes of harmonization.

      Hog, fat	 lowered from 0.7 ppm to 0.05 ppm
      Hog, meat byproducts	lowered from 1.5 ppm to 0.05 ppm
      Poultry, meat byproducts	lowered from 0.1 ppm to 0.05 ppm

Residues in Fish

At this time, residues in fish are not deemed an important issue for quinclorac and were not included in the assessment.  The USDA Pesticide Data Program (PDP) did not analyze for residues of quinclorac in catfish tested 2008-2010.  No tolerances are currently established for residues of quinclorac in fish.  However, the currently registered/proposed uses on rice and cranberry are aquatic crops, and HED has determined that label restrictions are needed regarding the uses of quinclorac-treated rice and cranberry fields for aquaculture.  Alternatively, HED has suggested that the petitioner could determine residues of quinclorac in catfish and crayfish raised in quinclorac-treated fields and propose tolerances for these commodities, if necessary.

According to the Quinclorac Summary Document Registration Review: Initial Docket December 2007, bioaccumulation in fish is not expected according to the acceptable fish accumulation study, which showed that after 28 days of exposure, quinclorac did not accumulate in channel catfish.  No bioconcentration factor was reported.  Furthermore, the octanol/water partition coefficient (KOW) of 0.266 also suggests that quinclorac has low potential to bioaccumulate.  

3.	Drinking Water Data
	
The quinclorac drinking water estimates used in these dietary risk assessments were provided by EFED (DP# 397720, M. Lowit/N. Andrews, 8/9/12 and DP# 405093, M. Lowit/N.Andrews, 9/14/12), and incorporated directly into the dietary assessments.  Water residues were incorporated in DEEM-FCID via entry into the food categories "water, direct, all sources" and "water, indirect, all sources."  The estimated drinking water concentrations (EDWCs) from existing and proposed uses of quinclorac for both acute and chronic scenarios in ground and surface water are 0.029 ppm and 0.511 ppm, respectively.  
	
Rice (labeled for a single application of 0.5 lb ai/A) was identified as the use resulting in the highest EDWCs for surface water.  Because the use on rice involves flooding (for which the current Tier II model is not parameterized), the surface water EDWCs were assessed using a Tier I Rice Model, Version 1.0 (May 8, 2007).  Turf grass was identified as the use resulting in the highest EDWCs for ground water.  The EDWC in ground water was assessed using the Tier I Screening Concentration in Ground Water (SCI-GROW, Version 2.3) model.  These models, and their descriptions, are available at the EPA internet website via the web link, http://www.epa.gov/oppefed1/models/water/.  No surface or ground water monitoring data were available for quinclorac.  

4.	Percent Crop Treated Information

The acute and chronic assessments are based on the assumption that 100% of all commodities with tolerances will be treated.

5.	DEEM-FCID Program and Consumption Information
	
Quinclorac acute and chronic dietary exposure assessments were conducted using the Dietary Exposure Evaluation Model software with the Food Commodity Intake Database DEEM-FCID, Version 3.16, which incorporates consumption data from USDA's National Health and Nutrition Examination Survey, What We Eat in America, (NHANES/WWEIA).  This dietary survey was conducted from 2003 to 2008.  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, but for acute exposure assessment 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.

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 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 tiers 1 and 2, any significant differences in user vs. per capita exposure and risk are specifically identified and noted in the risk assessment.

6.	Toxicological Information
	 	
An appropriate endpoint attributable to a single exposure to assess dietary exposure for the general populations including infants and children was not available from the oral toxicity studies including the rat and rabbit developmental toxicity studies.

An acute dietary POD of 200 mg/kg (NOAEL) for the sub-population females 13-49 years old was selected from a rabbit developmental toxicity study based on increased rate of resorptions and post-implantation loss, a decrease in the number of live fetuses, and reduced fetal body weight seen at 600 mg/kg/day.  A UF 100x (10x for intraspecies variation, 10x for interspecies extrapolation and a 1x FQPA safety factor) was applied to the dose to obtain an acute reference dose/population adjusted dose (aRfD/aPAD) of 2.0 mg/kg.

A chronic dietary POD of 38 mg/kg/day (NOAEL) was selected for the general population from a carcinogenicity study in mice based on effects on body weight.  A UF 100x (10x for intraspecies variation, 10x for interspecies extrapolation and a 1x FQPA factor) was applied to the dose to obtain a chronic reference dose/population adjusted dose (cRfD/cPAD) of 0.38 mg/kg/day.

Quinclorac was classified in 1992 by the HED Cancer Peer Review committee (CPRC) as a group D carcinogen - not classifiable as to human carcinogenicity- based on recommendation by the EPA Scientific Advisory Panel (TXR# 0010416).  This classification was based on equivocal increase in the incidence of one type of benign tumor (pancreatic acinar cell adenomas) in only one sex and one species of animals (male Wistar rats).  A quantification of cancer risk is not warranted because the chronic RfD will adequately account for all chronic effects, including the observed adenomas, likely to result from exposure to quinclorac. There was no evidence of carcinogenicity in mice or female rats.

Toxicological doses and endpoints for dietary human health risk assessments for quinclorac are presented below in Table 1.  For detailed information, please refer to the forthcoming human health risk assessment.  

TABLE 1.  Summary of Quinclorac Toxicological Doses and Endpoints for Use in Dietary Human Health Risk Assessments.
Exposure/
Scenario
                              Point of Departure
                        Uncertainty/FQPA Safety Factors
                RfD, PAD, Level of Concern for Risk Assessment
                        Study and Toxicological Effects
                                       
                                       
Acute Dietary (General Population, including Infants and Children)
Not applicable.  An endpoint for acute dietary exposure to the general population was not selected because there was no available endpoint that was appropriate for this scenario (effects observed in the available studies are presumed to require more than one exposure).
Acute Dietary
(Females 13-49 years of age)
NOAEL (developmental) = 200 mg/kg/day
UFA= 10x
UFH=10x
FQPA SF= 1x

aRfD =  2.0 mg/kg/day

aPAD = 2.0 mg/kg/day
Developmental toxicity study in rabbits (MRID# 41063525 and 41680501) Developmental toxicity LOAEL =  600 mg/kg/day based on increased early resorptions and postimplantation loss, decreased live fetuses, decreased fetal body weight.  These fetal effects are presumed to occur after a single dose.
Chronic Dietary (All Populations)
NOAEL= 37.5 mg/kg/day
UFA= 10x
UFH=10x
FQPA SF= 1x

cRfD = 0.38
mg/kg/day

cPAD =  0.38 mg/kg/day
Carcinogenicity study in mice MRID # 41063523)
LOAEL = 150 mg/kg/day based on decreased body weight.
Cancer (oral, dermal, inhalation)
Available carcinogenicity studies indicate that there was equivocal evidence of an increase in the incidence of pancreatic acinar cell adenomas in the male rat, but no treatment-associated increases in tumors were observed in female rats or in mice.  A quantification of cancer risk is not warranted because the chronic RfD of 0.375 mg/kg/day is approximately 1200-fold lower than the dose (487 mg/kg/day) that induced the benign pancreatic tumors.  Thus, the chronic RfD will adequately account for all chronic effects, including the observed adenomas, likely to result from exposure to quinclorac.   
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.  

7.	Results/Discussion
	
HED is concerned when dietary risk exceeds 100% of the PAD.  The DEEM-FCID analyses estimate the dietary exposure of the US population and various population subgroups.  The results of the acute analysis for females 13-49 are summarized in Table 2 (below).  As shown in Table 2, the risk estimates associated with acute dietary exposure to quinclorac are below HED's LOC.  
	
The acute dietary risk estimate at the 95[th] percentile of exposure is 1.6% of the aPAD for females age 13 to 49.  This is the only population subgroup for which an acute endpoint was selected.  

TABLE 2.  Summary of Acute Dietary Exposure and Risk Estimates for Quinclorac.  
                              Population Subgroup
                                [Years of Age]
                DEEM Acute Dietary Analysis (95[th] Percentile)
                                       
                               aPAD (mg/kg/day)
                         Exposure Estimate (mg/kg/day)
                                    % aPAD
Females [13-49]
                                      2.0
                                   0.032108
                                      1.6
 * NA = Not Applicable.  An appropriate acute endpoint was not identified for these population subgroups.  

The chronic dietary risk estimates are less than or equal to 8.9% of the chronic population adjusted dose (cPAD) for all population subgroups as shown in Table 3 (below).  All Infants <1year of age are the most highly-exposed subgroup, utilizing 8.9% of the cPAD, while the general US population utilizes 3.6% of the cPAD.  

TABLE 3.  Summary of Chronic Dietary Exposure and Risk Estimates for Quinclorac.  
                             Population Subgroup*
                                [Years of Age]
                         DEEM Chronic Dietary Analysis
                                       
                               cPAD (mg/kg/day)
                         Exposure Estimate (mg/kg/day)
                                    % cPAD
General US Population
                                     0.38
                                   0.013728
                                      3.6
All Infants [<1]
                                       
                                   0.033999
                                      8.9
Children [1-2]
                                       
                                   0.023500
                                      6.2
Children [3-5]
                                       
                                   0.019280
                                      5.1
Children [6-12]
                                       
                                   0.013431
                                      3.5
Youth [13-19]
                                       
                                   0.010195
                                      2.7
Adults [20-49]
                                       
                                   0.013614
                                      3.6
Adults [50-99]
                                       
                                   0.012525
                                      3.3
Females [13-49]
                                       
                                   0.012893
                                      3.4
 * Values for the population subgroup with the highest risk are in bold type.  

 8.	Characterization of Inputs/Outputs
	
This assessment is based on tolerance level residues in all agricultural commodities, assumes that all crops with existing or proposed tolerances are treated to a level of 100% and makes use of DEEM default processing factors.  In addition, Tier I drinking water estimates were used.  These assumptions result in highly conservative, health-protective estimates of dietary exposure and risk.  
 
 9.	Conclusions
	
Generally, the Agency is concerned when dietary risk estimates exceed 100% of the PAD.  All acute and chronic dietary risk estimates for quinclorac are below HED's level of concern.  
  
 
 10.	List of Attachments
Attachment 1.	Quinclorac Residues Used for Acute and Chronic Dietary Exposure Estimates.
Attachment 2.	Summary of the Acute Dietary Exposure and Risk Estimates for Quinclorac.
Attachment 3.	Summary of the Chronic Dietary Exposure and Risk Estimates for Quinclorac. 
 
 
Attachment 1.  Quinclorac Residues Used for Acute and Chronic Dietary Exposure Estimates.

U.S. EPA                                                        Ver. 3.16, 03-08-d
DEEM-FCID Acute and Chronic analysis for QUINCLORAC
Residue file name: QUINCLORACDEEM092412INPUT.R08
                                                               Adjust. #2 used
Analysis Date 09-24-2012             Residue file dated: 09-24-2012/10:44:12
Acute Reference dose (RfD) = 2.0 mg/kg bw/day (Females 13-49 only)
Chronic Reference dose (RfD) = 0.38 mg/kg bw/day
Comment:  Tolerances Used for Acute and Chronic Analyses
----------------------------------------------------------------------------------
 Food      Crop                                   Residue       Adj.Factors
EPA Code    Grp  Food Name                        (ppm)        #1         #2 
---------- ---- -------------------------------   ---------- ------     ------
1500025000 15   Barley, pearled barley             2.000000   1.000      1.000   
1500025001 15   Barley, pearled barley-babyfood    2.000000   1.000      1.000   
1500026000 15   Barley, flour                      2.000000   1.000      1.000   
1500026001 15   Barley, flour-babyfood             2.000000   1.000      1.000   
1500027000 15   Barley, bran                       2.000000   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   1.920      1.000   
3100046000 31   Beef, meat byproducts              1.500000   1.000      1.000   
3100046001 31   Beef, meat byproducts-babyfood     1.500000   1.000      1.000   
3100047000 31   Beef, fat                          0.700000   1.000      1.000   
3100047001 31   Beef, fat-babyfood                 0.700000   1.000      1.000   
3100048000 31   Beef, kidney                       1.500000   1.000      1.000   
3100049000 31   Beef, liver                        1.500000   1.000      1.000   
3100049001 31   Beef, liver-babyfood               1.500000   1.000      1.000   
1302057000 13B  Blueberry                          1.500000   1.000      1.000   
1302057001 13B  Blueberry-babyfood                 1.500000   1.000      1.000   
4000093000 40   Chicken, meat                      0.050000   1.000      1.000   
4000093001 40   Chicken, meat-babyfood             0.050000   1.000      1.000   
4000094000 40   Chicken, liver                     0.050000   1.000      1.000   
4000095000 40   Chicken, meat byproducts           0.050000   1.000      1.000   
4000095001 40   Chicken, meat byproducts-babyfoo   0.050000   1.000      1.000   
4000096000 40   Chicken, fat                       0.050000   1.000      1.000   
4000096001 40   Chicken, fat-babyfood              0.050000   1.000      1.000   
4000097000 40   Chicken, skin                      0.050000   1.000      1.000   
4000097001 40   Chicken, skin-babyfood             0.050000   1.000      1.000   
1307130000 13G  Cranberry                          1.500000   1.000      1.000   
1307130001 13G  Cranberry-babyfood                 1.500000   1.000      1.000   
1307131000 13G  Cranberry, dried                   1.500000   1.000      1.000   
1307132000 13G  Cranberry, juice                   1.500000   1.100      1.000   
1307132001 13G  Cranberry, juice-babyfood          1.500000   1.100      1.000   
7000145000 70   Egg, whole                         0.050000   1.000      1.000   
7000145001 70   Egg, whole-babyfood                0.050000   1.000      1.000   
7000146000 70   Egg, white                         0.050000   1.000      1.000   
7000146001 70   Egg, white (solids)-babyfood       0.050000   1.000      1.000   
7000147000 70   Egg, yolk                          0.050000   1.000      1.000   
7000147001 70   Egg, yolk-babyfood                 0.050000   1.000      1.000   
3200169000 32   Goat, meat                         0.050000   1.000      1.000   
3200170000 32   Goat, meat byproducts              1.500000   1.000      1.000   
3200171000 32   Goat, fat                          0.700000   1.000      1.000   
3200172000 32   Goat, kidney                       1.500000   1.000      1.000   
3200173000 32   Goat, liver                        1.500000   1.000      1.000   
3300189000 33   Horse, meat                        0.050000   1.000      1.000   
3800221000 38   Meat, game                         0.050000   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   
3400290000 34   Pork, meat                         0.050000   1.000      1.000   
3400290001 34   Pork, meat-babyfood                0.050000   1.000      1.000   
3400291000 34   Pork, skin                         0.050000   1.000      1.000   
3400292000 34   Pork, meat byproducts              0.050000   1.000      1.000   
3400292001 34   Pork, meat byproducts-babyfood     0.050000   1.000      1.000   
3400293000 34   Pork, fat                          0.050000   1.000      1.000   
3400293001 34   Pork, fat-babyfood                 0.050000   1.000      1.000   
3400294000 34   Pork, kidney                       0.050000   1.000      1.000   
3400295000 34   Pork, liver                        0.050000   1.000      1.000   
6000301000 60   Poultry, other, meat               0.050000   1.000      1.000   
6000302000 60   Poultry, other, liver              0.050000   1.000      1.000   
6000303000 60   Poultry, other, meat byproducts    0.050000   1.000      1.000   
6000304000 60   Poultry, other, fat                0.050000   1.000      1.000   
6000305000 60   Poultry, other, skin               0.050000   1.000      1.000   
3900312000 39   Rabbit, meat                       0.050000   1.000      1.000   
0402322000 4B   Rhubarb                            0.500000   1.000      1.000   
1500323000 15   Rice, white                        5.000000   1.000      1.000   
1500323001 15   Rice, white-babyfood               5.000000   1.000      1.000   
1500324000 15   Rice, brown                        5.000000   1.000      1.000   
1500324001 15   Rice, brown-babyfood               5.000000   1.000      1.000   
1500325000 15   Rice, flour                        5.000000   1.000      1.000   
1500325001 15   Rice, flour-babyfood               5.000000   1.000      1.000   
1500326000 15   Rice, bran                        15.000000   1.000      1.000   
1500326001 15   Rice, bran-babyfood               15.000000   1.000      1.000   
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             1.500000   1.000      1.000   
3500341000 35   Sheep, fat                         0.700000   1.000      1.000   
3500341001 35   Sheep, fat-babyfood                0.700000   1.000      1.000   
3500342000 35   Sheep, kidney                      1.500000   1.000      1.000   
3500343000 35   Sheep, liver                       1.500000   1.000      1.000   
1500344000 15   Sorghum, grain                     6.000000   1.000      1.000   
1500345000 15   Sorghum, syrup                     6.000000   1.000      1.000   
1500381000 15   Triticale, flour                   0.500000   1.000      1.000   
1500381001 15   Triticale, flour-babyfood          0.500000   1.000      1.000   
5000382000 50   Turkey, meat                       0.050000   1.000      1.000   
5000382001 50   Turkey, meat-babyfood              0.050000   1.000      1.000   
5000383000 50   Turkey, liver                      0.050000   1.000      1.000   
5000383001 50   Turkey, liver-babyfood             0.050000   1.000      1.000   
5000384000 50   Turkey, meat byproducts            0.050000   1.000      1.000   
5000384001 50   Turkey, meat byproducts-babyfood   0.050000   1.000      1.000   
5000385000 50   Turkey, fat                        0.050000   1.000      1.000   
5000385001 50   Turkey, fat-babyfood               0.050000   1.000      1.000   
5000386000 50   Turkey, skin                       0.050000   1.000      1.000   
5000386001 50   Turkey, skin-babyfood              0.050000   1.000      1.000   
8601000000 86A  Water, direct, all sources         0.511000   1.000      1.000   
8602000000 86B  Water, indirect, all sources       0.511000   1.000      1.000   
1500401000 15   Wheat, grain                       0.500000   1.000      1.000   
1500401001 15   Wheat, grain-babyfood              0.500000   1.000      1.000   
1500402000 15   Wheat, flour                       0.500000   1.000      1.000   
1500402001 15   Wheat, flour-babyfood              0.500000   1.000      1.000   
1500403000 15   Wheat, germ                        0.750000   1.000      1.000   
1500404000 15   Wheat, bran                        0.500000   1.000      1.000   
1500405000 15   Wild rice                          5.000000   1.000      1.000   

Attachment 2.  Summary of the Acute Dietary Exposure and Risk Estimates for Quinclorac.
 

U.S. EPA                                                    Ver. 3.16, 03-08-d
DEEM-FCID ACUTE Analysis for QUINCLORAC                  NHANES 2003-2008 2-Day
Residue file name: QUINCLORACDEEM092412INPUT.R08           Adjustment factor #2 used.
Analysis Date: 09-24-2012/10:46:50    Residue file dated: 09-24-2012/10:44:12
RAC/FF intake summed over 24 hours
Run Comment: Acute is for Females 13-49 only.
===============================================================================

Summary calculations--per capita:

                   95th Percentile      99th Percentile     99.9th Percentile
                   Exposure   % aRfD    Exposure   % aRfD    Exposure   % aRfD 
                  ---------- --------  ---------- --------  ---------- --------
Female 13-49:
                    0.032108     1.61    0.043819     2.19    0.060306     3.02 

                  Attachment 3.  Summary of the Chronic Dietary Exposure and Risk Estimates for Quinclorac.
 

U.S. EPA                                                        Ver. 3.16, 03-08-d
DEEM-FCID Chronic analysis for QUINCLORAC                  NHANES 2003-2008 2-day
Residue file name: QUINCLORACDEEM092412INPUT.R08
                                                     Adjustment factor #2 used.
Analysis Date 09-24-2012/10:45:30     Residue file dated: 09-24-2012/10:44:12
Reference dose (RfD, Chronic) = .38 mg/kg bw/day
COMMENT 1: 
===============================================================================
                    Total exposure by population subgroup
-------------------------------------------------------------------------------

                                                    Total Exposure
                                         -----------------------------------
          Population                         mg/kg             Percent of   
           Subgroup                       body wt/day             Rfd       
--------------------------------------   -------------       ----------------
Total US Population                         0.013728                 3.6%
Hispanic                                    0.013922                 3.7%
Non-Hisp-White                              0.013714                 3.6%
Non-Hisp-Black                              0.011683                 3.1%
Non-Hisp-Other                              0.018298                 4.8%
Nursing Infants                             0.013500                 3.6%
Non-Nursing Infants                         0.043154                11.4%
Female 13+ PREG                             0.012415                 3.3%
Children 1-6                                0.020422                 5.4%
Children 7-12                               0.012785                 3.4%
Male 13-19                                  0.009941                 2.6%
Female 13-19/NP                             0.010453                 2.8%
Male 20+                                    0.013090                 3.4%
Female 20+/NP                               0.013237                 3.5%
Seniors 55+                                 0.012155                 3.2%
All Infants                                 0.033999                 8.9%
Female 13-50                                0.012889                 3.4%
Children 1-2                                0.023500                 6.2%
Children 3-5                                0.019280                 5.1%
Children 6-12                               0.013431                 3.5%
Youth 13-19                                 0.010195                 2.7%
Adults 20-49                                0.013614                 3.6%
Adults 50-99                                0.012525                 3.3%
Female 13-49                                0.012893                 3.4%

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