Document ID: EPA-HQ-OPP-2010-0268-0005
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2011-06-01T04:00Z

\s \* MERGEFORMAT
                 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
                            WASHINGTON, D.C.  20460

                                                                               
                                                     OFFICE OF CHEMICAL SAFETY 
                                                                                                        AND POLLUTION PREVENTION

MEMORANDUM

DATE:  	22-March-2011  

SUBJECT:	Bromoxynil:  Acute, Chronic, and Cancer Aggregate Dietary (Food and Drinking Water) Exposure and Risk Assessments for the New Uses on Grass and Grain Sorghum

PC Codes:  035301, 035302
DP Barcode:  D378615
Decision No.:  425581
Registration No.:  264-1023
Petition No.: 9F7678
Regulatory Action:  Section 3 Registration
Risk Assessment Type:  Single Chemical
Case No.:  2070
TXR No.:  NA
CAS No.:  1689-84-9
MRID No.:  NA 
40 CFR:  §180.324

REVIEWER:	Cassi L. Walls, Ph.D., Senior Biologist
		Risk Assessment Branch III/Health Effects Division (HED; 7509P)

THROUGH:	Thomas Bloem, Chemist
            Breann Hanson, Biologist 
            Dietary Exposure Science Advisory Council (DESAC)/HED (7509P)
            
                  and

            Paula Deschamp, Branch Chief
            Risk Assessment Branch III/HED (7509P)
            
TO:		Cassi L. Walls, Risk Assessor
            Risk Assessment Branch III/HED (7509P)
            
            and
            
            Bethany Benbow, RM Team 23
            Registration Division (RD; 7505P) 

Executive Summary

Acute, chronic, and cancer aggregate dietary (food and drinking water) exposure and risk assessments were conducted for bromoxynil using the Dietary Exposure Evaluation Model DEEM-FCID(TM), Version 2.03 which use food consumption data from the U.S. Department of Agriculture's Continuing Surveys of Food Intakes by Individuals (CSFII) from 1994-1996 and 1998.  The analyses were performed to support Section 3 requests for new uses on grass and grain sorghum.  The most recent acute, chronic, and cancer aggregate dietary assessments were conducted for bromoxynil to support the Reregistration Eligibility Decision (RED) in December, 1998.  

Acute Dietary Exposure Results and Characterization

A refined dietary acute analysis was conducted for bromoxynil.  Average field trial values for grains and anticipated residues in livestock were used in the assessment.  Tolerance level residues were used for cotton, garlic, onion, peppermint and spearmint.  Maximum percent crop treated estimates provided by BEAD were used for all crop commodities.  Potential residues in drinking water were included in the analyses based on surface water results from the Tier I FIRST model as these values were higher than the groundwater estimates from the SCI-GROW model.  At the 99.9[th] percentile of the exposure distribution, no population subgroups exceed HED's level of concern:  the US population occupied just 3.3% of the acute Population Adjusted Dose (aPAD), while the most highly exposed population subgroup, all infants (< 1 year old), occupied 7.4% of the aPAD.  Analyses with and without demonstrate that water adds only marginally to the acute dietary exposure of bromoxynil.   

Chronic Dietary Exposure Results and Characterization

A refined chronic dietary assessment was conducted for bromoxynil.  Average field trial residues were used for all commodities except for spearmint and peppermint where tolerance values were used.  Livestock anticipated residues were estimated using average percent crop treated data, average field trial residue values, and results from the animal feeding studies.  Average percent crop treated estimates provided by BEAD were used for all crop commodities.  Potential residues in drinking water were included in the analyses based on surface water results from the Tier I FIRST model as these values were higher than the groundwater estimates from the SCI-GROW model.  At this level of refinement, no population subgroups exceed HED's level of concern:  the US population occupied 0.1% of the chronic Population Adjusted Dose (cPAD), while the most highly exposed population subgroup, Children 1-2 years old, occupied 0.3% of the cPAD.  Analyses with and without water demonstrate that water adds only marginally to the chronic dietary exposure of bromoxynil.  

Cancer Dietary Exposure Results and Characterization

A determination of cancer risk was also performed with DEEM-FCID(TM) as part of the present assessment, since this chemical was classified as "Possible Human Carcinogen" based on based on male mouse hepatocellular tumors found in the long term cancer studies.  The cancer analyses yielded an aggregate (food and water) risk estimate of 1.5 x 10[-6] for the general US Population.  

I.	Introduction

Dietary risk assessment incorporates both exposure and toxicity of a given pesticide.  For acute and chronic assessments, the risk is expressed as a percentage of a maximum acceptable dose (i.e., the dose which HED has concluded will result in no unreasonable adverse health effects).  This dose is referred to as the population adjusted dose (PAD).  The PAD is equivalent to point of departure (POD, NOAEL, LOAEL, e.g.) divided by the required uncertainty or safety factors.

For acute and non-cancer chronic exposures, HED is concerned when estimated dietary risk exceeds 100% of the PAD.  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 acute, chronic, and cancer aggregate dietary assessments were conducted for bromoxynil to support the Reregistration Eligibility Decision (RED) in December, 1998.  This document serves as an update to the last dietary assessment for bromoxynil using current approaches and input data.

II.	Residue Information

Bromoxynil (3,5-dibromo-4-hydroxybenzonitrile) is a contact herbicide which is registered for application as the octanoic and/or heptanoic acid esters for control of broadleaf weeds in various crops.  The octanoic and heptanoic acid esters are rapidly converted to the phenol (bromoxynil) which inhibits photosynthetic electron transport and oxidative phosphorylation in mitochondria.   Tolerances are currently established under 40 CFR §180.324(a)(1) for bromoxynil residues resulting from application of its octanoic and/or heptanoic acid ester in or on alfalfa, barley, field and pop corn, flax, garlic, aspirated grain fractions, grass, oat, onion, peppermint, rye, sorghum, spearmint, and wheat commodities at levels ranging from 0.05 ppm to 9.0 ppm.  Tolerances are currently established under 40 CFR §180.324(a)(2) for bromoxynil residues and its metabolite, 3,5-dibromo-4-hydroxybenzoix acid (DBHA), resulting from application of its octanoic and/or heptanoic acid ester in or on cotton commodities and in egg, milk, and the meat, fat, and meat byproducts of cattle, goat, hog, horse, poultry and sheep at levels ranging from 0.05 ppm to 7.0 ppm.   A tolerance amendment is being requested by Bayer CropScience for increasing the tolerance of bromoxynil on sorghum, grain and grass grown for seed [grass hay and grass forage].

HED has concluded that the nature of the residue in plants is adequately understood.  The residue of concern in plants other than cotton is bromoxynil.  The residues of concern in transgenic BXN cotton and cotton commodities are bromoxynil and its metabolite DBHA.   The DBHA metabolite is only found in transgenic cotton, and not in other commodities.   Except for the transgenic cotton metabolite DBHA, the nature of the residue in livestock is adequately understood for bromoxynil.  Pending the receipt of an additional livestock metabolism study for DBHA, bromoxynil is the residue of concern in livestock commodities for the tolerance expression while bromoxynil and DBHA are the residues of concern in livestock commodities for the risk assessment (D378614, Nancy Dodd, 17-NOV-2010).  Residue information for the proposed amended tolerances included in the present analyses was taken from the bromoxynil residue chemistry memo (D378614, Nancy Dodd, 17-NOV-2010).   

A refined dietary acute analysis was conducted for bromoxynil.  For all grains, average field trial values were used since grains are considered to be blended commodities.  Tolerance levels were used for cotton, garlic, onion, peppermint and spearmint.  Livestock anticipated residues were estimated using results from the crop field trials and animal feeding studies (D378614, Nancy Dodd, 17-NOV-2010).  Maximum percent crop treated estimates provided by BEAD were used for all crop commodities (D382833, Arthur Grube, 22-OCT-2010) and (D378991, Jihad Alsadek, 08-July-2010).   Default processing factors were used. 

Refined dietary chronic and cancer analyses were conducted for bromoxynil.  Average field trial residues were used for all commodities except for spearmint and peppermint where tolerance values were used.  Livestock anticipated residues were estimated using average percent crop treated data, average field trial residue values, and results from the animal feeding studies (D378614, Nancy Dodd, 17-NOV-2010).  Average percent crop treated estimates provided by BEAD were used for all crop (D382833, Arthur Grube, 22-OCT-2010) and (D378991, Jihad Alsadek, 08-July-2010).   Default processing factors were used.  Table 1 summarizes the bromoxynil residue levels, percent crop treated values, and processing factors for all crops and livestock commodities used in the acute, chronic and cancer dietary assessments.  

Table 1.  Summary of Bromoxynil Residue Levels For All Crops Used in Acute, Chronic, and Cancer Analyses.
Matrix
                              Anticipated Residue
                                 [Acute] (ppm)
                                  Anticipated
                                    Residue
                                   [Chronic/
                                 Cancer] (ppm)
                         Average Percent Crop Treated
                             [Chronic/ Cancer][1]
                           Max. Percent Crop Treated
                                   [Acute] 1
                                       
Processing Factors
Alfalfa[2]
                                     0.13
                                     0.13
                                     <1
                                    <2.5

Cereal grains [3]
   Barley
   Corn
   Oats
   Rye
   Wheat
                                     0.01
                                     0.01
                                       
                                      20
                                    <2.5
                                       5
                                     <1
                                      15
                                       
                                      35
                                       5
                                       5
                                     <1
                                      35

Corn Syrup: 1.5
Flax, seed [4]
                                     0.01
                                     0.01
                                      35
                                      35

Sorghum [5]
                                     0.028
                                     0.028
                                    <2.5
                                    <2.5

Cotton [6]
                                      1.5
                                      0.3
                                    <2.5
                                       5

Garlic [7]
                                      0.1
                                     0.01
                                      50
                                      70

Onion[7]
                                      0.1
                                     0.01
                                      55
                                      70
Dried: 9.0
Mint (peppermint and spearmint) [8]
                                      0.1
                                      0.1
                                      25
                                      25

Cattle, goat, horse, sheep; 
Fat[9]
                                     0.13
                                    0.0024

Cattle, goat, horse, sheep; 
meat byproducts[9]
                                 Kidney: 0.43
                                  Liver: 0.38
                                Kidney: 0.0081
                                 Liver: 0.0070

Cattle, goat, horse, sheep;
 Meat[9]
                                     0.070
                                    0.0013

Dried:1.92
Egg[9]
                                    0.0038
                                   0.000078

Hog, fat[9]
                                    0.0062
                                    0.00015

Hog, meat byproducts[9]
                                 Kidney: 0.020
                                 Liver: 0.018
                                Kidney: 0.00051
                                Liver: 0.00044

Hog, meat[9]
                                    0.0033
                                   0.000083

Milk[9]
                                    0.0032
                                    0.00054

Poultry, fat[9]
                                    0.0061
                                    0.00013

Poultry, meat byproducts[9]
                                 Liver: 0.048
                                Liver: 0.00099

Poultry, meat[9]
                                    0.0038
                                   0.000078

[1] Usage Report package in Support of Registration for the Herbicide Bromoxynil  (D382833, Arthur Grube, 22-OCT-2010) and (D378991, Jihad Alsadek, 08-July-2010)

[2] DP Number 195998, C. Swartz, 3/6/96, MRIDs 00150382, 42950101 (alfalfa); MRID 44386601.  The average residue for alfalfa 0.13 ppm was used 

[3] DP Number 235876, C. Swartz, 5/14/97, DP Number 234836, C. Swartz, 4/3/97, DP Number 233336, C. Swartz, 3/20/97, and DP Number 228201, C. Swartz, 7/29/96.  Residue data for wheat and barley grains were translated to oats and rye.   All residues in wheat and barley grains were <0.02 ppm (<LOQ).  Therefore, the anticipated residue for grain of barley, oat, rye and wheat is 0.01 ppm, or (1/2) LOQ (LOQ = 0.02 ppm).  Since residues do not concentrate in processed commodities of cereal grains, the anticipated residue of 0.01 ppm should be used for the processed commodities.

DP Number 191340, C. Swartz, 10/24/94, MRID 42757601 and D183667, S. Knizner, 11/13/92, MRID 42501601; MRID 44386601.   All residues in corn grain were <0.02 ppm (<LOQ).  Therefore, the anticipated residue for corn grain is 0.01 ppm, or (1/2) LOQ (LOQ = 0.02 ppm).

4  DP Number 178167, S. Knizner, 10/29/92, MRID 42283201).  All residues in flax seed were <0.02 ppm.  Therefore, the anticipated residue for flax seed is 0.01 ppm, or (1/2) LOQ (LOQ = 0.02 ppm).  Since residues do not concentrate in processed commodities of flax seed, the anticipated residue of 0.01 ppm should be used for the processed commodities of flax seed.

[5] DP Number 380770, T. Goodlow, 8/17/10, MRID 47815002 (grain sorghum).  The average residue was used for the chronic assessment and in the acute assessment since it is a blended commodity.

[6] DP Number 44458900, C. Swartz, 3/2/98.  The tolerance value is used in the acute assessment and the average residue value from the field trial is used in the chronic assessment.

[7] DP Number 235876, C. Swartz, 5/14/97, DP Number 234836, C. Swartz, 4/3/97, DP Number 233336, C. Swartz, 3/20/97, and DP Number 228201, C. Swartz, 7/29/96.  Residue data on onions were translated to garlic.  Residues on onions were <0.02 ppm (<LOQ). Therefore, the chronic anticipated residue for onions and garlic is 0.01 ppm, or (1/2) LOQ (LOQ = 0.02 ppm).  The tolerance value is used in the acute assessment.

[8] Tolerance values are used in both the acute and chronic assessments.

9 Anticipated residues in livestock were based on updated dietary burden calculations which are presented in Attachment 9.

III. 	Drinking Water Data

The drinking water residues used in the dietary risk assessment were provided by the Environmental Fate and Effects Division (EFED) (D374620, Tiffany Mason, 16-DEC-2010).  Water residues presented in Table 2 were directly incorporated in the DEEM-FCID into the food categories "water, direct, all sources" and "water, indirect, all sources."   

Table 2.  Summary of Estimated Surface Water and Groundwater Concentrations
                                       
                                Surface Water a
                                 Ground Water
                                  Use Pattern
                                   Peak EEC
                               Annual Mean  EEC
                               Peak and Mean EEC
                                       
           ----------------------- μg/L---------------------------
                                     ng/L
Grasses for Seed
                                     10.2
                                     0.17
                                     1.24
Sorghum
                                     11.5
                                     0.19
                                     1.33
                            Revised Cotton Numbers
Cotton
                                     4.34
                                     0.07
                                     3.26 
[a] From the Tier I FIRST model.  Input parameters are based the sorghum application of 2 applications of 0.305 lbs. ai/A at 11-day interval

Surface Water.  The Tier I screening models FIRST Version 1.1.1 (FQPA Index Reservoir Screening Tool) with Percent Crop Area adjustment factor was used to determine drinking water concentrations of bromoxynil derived from surface water sources.  For the Peak EEC, the highest FIRST estimated drinking water concentration (EDWC) for bromoxynil was 11.5 μg/L based on application to sorghum.  For annual average, the highest FIRST EDWC was 0.19 μg/L, also based on application to sorghum.  

Groundwater.  SCI-GROW model (Screening Concentration in Ground Water Program (SCI-GROW) VERSION 2.3.0 was used to predict the water concentrations of bromoxynil derived from shallow ground water.  The cotton resulted in the highest groundwater EDWC of 0.00326 μg/L.  However, because the surface water estimates were higher than the groundwater estimates, the present analyses made use of the former values, expressed to two significant figures and converted into the proper units for the DEEM program (ppm).

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

Bromoxynil acute and chronic dietary exposure assessments were conducted using the DEEM-FCID(TM) version 2.03 modeling software.  It uses food consumption data from the U.S. Department of Agriculture (USDA) CSFII 1994-1996 and 1998 food intake surveys.  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 US population and within population subgroups.  Based on analysis of the 1994-96, 98 CSFII consumption data, which took into account dietary patterns of 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 assessments, 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 cRfD.  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 tiers 1 and 2, any significant differences in user vs. per capita exposure and risk are specifically identified and noted in the risk assessment.

V.	Toxicological Information

All current information specific to the toxicity characteristics of bromoxynil will be presented in the upcoming risk assessment supporting the proposed uses (D374609, Cassi Walls).  For the acute and chronic exposure scenarios, the standard 100 fold UF was applied to account for inter-species extrapolation and intra-species variation.  The points of departure used in the dietary assessments remain unchanged from the previous assessment conducted in 1998.  However, it should be noted that based on a recent BMD analysis, ToxSAC recommended that the 10x FQPA SF for females 13-49 years of age used in the previous risk assessment be reduced to 1x (D374609).  A cancer risk evaluation is also included in this assessment.  

To provide an overview of the toxicological profile, a summary of the doses and endpoints selected for the relevant dietary exposure scenarios is provided in Table 3.  

Table 3.  Summary of Toxicological Doses and Endpoints for Bromoxynil 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 (General Population, including Infants and Children)
NOAEL = 8 mg/kg/day
UFA = 10x 
UFH = 10x 
FQPA SF = 1x 

Acute RfD = 0.08  mg/kg/day

aPAD = 0.08  mg/kg/day
Subchronic study in Dogs
The LOAEL for effects attributed to a single dose was 12 mg/kg based on panting.  In addition to panting, elevated rectal temperatures occurred at 16 mg/kg and above, and death occurred at 30 mg/kg and above after a single dose on day 1
Acute Dietary
(Females 13-49 years of age)
NOAEL= 4 mg/kg/day
UFA= 10 x
UFH=10 x
FQPA SF=1x

Acute RfD = 0.04  mg/kg/day

aPAD = 0.04  mg/kg/day
Developmental Studies in Rats 
The LOAEL of 5 mg/kg/day is based on an increase of supernumery ribs from MRID 00116558.  The NOAEL is derived from a co-critical study (MRID 40466802)
Chronic Dietary (All Populations)
NOAEL = 1.5 mg/kg/day
UFA = 10x 
UFH = 10x 
FQPA SF= 1x 
Chronic RfD = 0.015
mg/kg/day

cPAD = 0.015 mg/kg/day
Chronic (1 year) Study in dogs
The LOAEL of 7.5 mg/kg/day, M & F is based on increased incidences of salivation, panting, liquid feces and pale gums; statistically significant decreased body weight gain over entire duration of study, but particularly during first 8 weeks of study; statistically significant decreased erythrocytes (RBC), hemoglobin (Hb) and packed cell volume (PCV); statistically significant increased urea nitrogen; increased absolute liver weights and liver/body weight ratios..
Cancer 
Bromoxynil phenol has been classified by the HED Carcinogenicity Peer Review Committee (E. Budd and E. Rinde, 3/12/1997, TXR 0050045) as a Group C, possible human carcinogen, based on male mouse hepatocellular tumors.  The committee also recommended that a low dose extrapolation model (Q1*) be applied to the experimental animal tumor data for quantification of human risk.  Q1* = 0.103 (mg/kg/day)[-1]
Point of Departure (POD) = A data point or an estimated point that is derived from observed dose-response data and  used to mark the beginning of extrapolation to determine risk associated with lower environmentally relevant human exposures.  NOAEL = no observed adverse effect level.  LOAEL = lowest observed adverse effect level.  UF = uncertainty factor.  UFA = extrapolation from animal to human (intraspecies).  UFH = potential variation in sensitivity among members of the human population (interspecies).  FQPA SF = FQPA Safety Factor.  PAD = population adjusted dose (a = acute, c = chronic).  RfD = reference dose. 

VI.	Results/Discussion 

As stated above, for acute and chronic assessments, HED is concerned when dietary risk exceeds 100% of the PAD.  The DEEM-FCID(TM) analyses estimate the dietary exposure of the US population and various population subgroups.  The results reported in Table 5 are for the general US 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

Refined acute dietary risk analyses were conducted with the DEEM-FCID(TM) model to form a conservative evaluation of exposure for bromoxynil.  At the 95[th], 99[th], and 99.9[th] percentiles of exposure, all acute analyses yielded risk estimates well below the 100% of the aPAD threshold level of concern for each population subgroup.  For the general US Population subgroup, acute aggregate dietary risk was calculated at 3.3% of the aPAD with an exposure level of 0.0026 mg/kg/day at the 99.9[th] percentile of exposure.  For the subgroup with the highest calculated exposure, all infants (<1 year old), acute aggregate dietary risk occupied 7.4% of the aPAD with an exposure of 0.0059 mg/kg/day at the 99.9[th] percentile of exposure.  Comparison of the food only results to the food + water results demonstrates that the additional risk added by water consumption is relatively small.  An overview summarizing the results of the acute dietary assessments with the population subgroup having the highest exposure noted in bold is presented in Tables 4 and 5.

Table 4.  Results of Acute Dietary (Food Only) Exposure Analysis Using  DEEM FCID 
                              Population Subgroup
                                aPAD (mg/kg/day)
                               95[th] Percentile
                               99[th] Percentile
                              99.9[th] Percentile
 
 
                              Exposure (mg/kg/day)
                                     % aPAD
                              Exposure (mg/kg/day)
                                     % aPAD
                              Exposure (mg/kg/day)
                                   %     aPAD
 General U.S. Population
                                      0.08
                                    0.000429
                                      0.54
                                    0.000788
                                      1.0
                                    0.001504
                                      1.9
 All Infants (< 1 year old)
 
                                    0.000472
                                      0.59
                                    0.001011
                                      1.3
                                    0.002311
                                      2.9
 Children 1-2 years old
 
                                    0.000950
                                      1.2
                                    0.001439
                                      1.8
                                    0.002472
                                      3.1
 Children 3-5 years old
 
                                    0.000815
                                      1.0
                                    0.001330
                                      1.7
                                    0.002682
                                      3.4
 Children 6-12 years old
 
                                    0.000563
                                      0.70
                                    0.000901
                                      1.1
                                    0.001924
                                      2.4
 Youth 13-19 years old
 
                                    0.000382
                                      0.48
                                    0.000654
                                      0.82
                                    0.001503
                                      1.9
 Adults 20-49 years old
 
                                    0.000340
                                      0.43
                                    0.000561
                                      0.70
                                    0.001165
                                      1.5
 Adults 50+ years old
 
                                    0.000266
                                      0.33
                                    0.000458
                                      0.57
                                    0.001134
                                      1.4
 Females 13-49 years old 
                                      0.04
                                    0.000296
                                      0.74
                                    0.000493
                                      1.2
                                    0.000912
                                      2.3

Table 5.  Results of Acute Dietary (Food and Drinking Water) Exposure Analysis Using  DEEM FCID 
                              Population Subgroup
                                aPAD (mg/kg/day)
                               95[th] Percentile
                               99[th] Percentile
                              99.9[th] Percentile
 
 
                              Exposure (mg/kg/day)
                                     % aPAD
                              Exposure (mg/kg/day)
                                     % aPAD
                              Exposure (mg/kg/day)
                                   %     aPAD
 General U.S. Population
                                      0.08
                                 0.000900     
                                      1.1
                                 0.001500     
                                      1.9
                                 0.002639     
                                      3.3
 All Infants (< 1 year old)
 
                                 0.002374     
                                      3.0
                                    0.003338
                                      4.2
                                    0.005892
                                      7.4
 Children 1-2 years old
 
                                 0.001570     
                                      2.0
                                 0.002305     
                                      2.9
                                 0.003714     
                                      4.6
 Children 3-5 years old
 
                                 0.001425     
                                      1.8
                                    0.002124
                                      2.7
                                    0.003527
                                      4.4
 Children 6-12 years old
 
                                 0.001008     
                                      1.3
                                 0.001475     
                                      1.9
                                 0.002151     
                                      2.7
 Youth 13-19 years old
 
                                 0.000700     
                                      0.88
                                 0.001142     
                                      1.4
                                 0.002507     
                                      3.1
 Adults 20-49 years old
 
                                 0.000756     
                                      1.0
                                 0.001164     
                                      1.5
                                 0.001965     
                                      2.5
 Adults 50+ years old
 
                                 0.000654     
                                      0.82
                                 0.000961     
                                      1.2
                                 0.001482     
                                      1.9
 Females 13-49 years old 
                                      0.04
                                 0.000728     
                                      1.8
                                 0.001091     
                                      2.7
                                 0.001756     
                                      4.4

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

Chronic dietary risk analyses were conducted with the DEEM-FCID(TM) model to form a refined evaluation of exposure to bromoxynil.  All chronic analyses yielded risk estimates well below the 100% of the cPAD threshold level of concern for each population subgroup.  For the general US Population, chronic aggregate dietary risk was calculated at 0.1% of the cPAD with an exposure level of 0.000014 mg/kg/day.  For the subgroup with the highest calculated exposure, Children 1-2 years old, chronic aggregate dietary risk occupied 0.3% of the cPAD with an exposure of 0.000040 mg/kg/day.  Comparison of the food only results to the food + water results demonstrates that the additional risk added by water consumption is small.  An overview summarizing the results of the chronic dietary assessment with the population subgroup having the highest exposure noted in bold is presented in Table 6.

A determination of cancer risk was also performed with DEEM-FCID(TM) as part of the present assessment, since this chemical was classified as "Possible Human Carcinogen" based on based on male mouse hepatocellular tumors found in the long term cancer studies.  The cancer analyses yielded an aggregate (food and water) risk estimate of 1.5 x 10[-6] for the general US Population.  Comparison of the food only results to the food + water results demonstrates that the additional risk added by water consumption is small.  An overview summarizing the results of the cancer dietary assessments is presented in Table 7.
 

Table 6.  Results of Chronic Dietary Exposure and Risk Estimates for Bromoxynil.
                              Population Subgroup
                                PAD, mg/kg/day
                             DEEM-FCID (food only)
                          DEEM-FCID (food and water)

                              Exposure, mg/kg/day
                                     % PAD
                              Exposure, mg/kg/day
                                     %PAD
U.S. Population
                                       
                                       
                                       
                                       
                                     0.015
                           0.000010                 
                                      0.1
                           0.000014                 
                                      0.1
All infants (< 1 yr)
                                       
                                   0.000011
                                      0.1
                                   0.000024
                                      0.2
Children 1-2 yrs
                                       
                           0.000034                 
                                      0.2
                           0.000040                 
                                      0.3
Children 3-5 yrs
                                       
                           0.000026                 
                                      0.2
                           0.000032                 
                                      0.2
Children 6-12 yrs
                                       
                           0.000017                 
                                      0.1
                           0.000021                 
                                      0.1
Youth 13-19 yrs
                                       
                           0.000010                 
                                      0.1
                           0.000013                 
                                      0.1
Adults 20-49 yrs
                                       
                           0.000008                 
                                      0.1
                           0.000011                 
                                      0.1
Adults 50+ yrs
                                       
                           0.000006                 
                                    <0.1
                           0.000010                 
                                      0.1
Females 13-49 yrs
                                       
                           0.000007                 
                                    <0.1
                           0.000011                 
                                      0.1

Table 7.  Results of Cancer Exposure and Risk Estimates for Bromoxynil.
                              Population Subgroup
                                      Q*
                                (mg/kg/day)[-1]
                             DEEM-FCID (food only)
                          DEEM-FCID (food and water)

                              Exposure, mg/kg/day
                                     Risk
                              Exposure, mg/kg/day
                                     Risk
U.S. Population
                                     0.103
                                       
                                       
                                       
                                       
                           0.000010                 
                                 1.1 x 10[-6]
                               0.000014         
                                 1.5 x 10[-6]
All infants (< 1 yr)
                                       
                                      NA
                                      NA
                                      NA
                                      NA
Children 1-2 yrs
                                       
                                       
                                       
                                       
                                       
Children 3-5 yrs
                                       
                                       
                                       
                                       
                                       
Children 6-12 yrs
                                       
                                       
                                       
                                       
                                       
Youth 13-19 yrs
                                       
                                       
                                       
                                       
                                       
Adults 20-49 yrs
                                       
                                       
                                       
                                       
                                       
Adults 50+ yrs
                                       
                                       
                                       
                                       
                                       
Females 13-49 yrs
                                       
                                       
                                       
                                       
                                       

VII.	Characterization of Inputs/Outputs
 
The acute dietary assessment conducted with DEEM-FCID(TM) for bromoxynil is a relatively refined analysis.  The refinements include: average field trial values for all grains; estimated livestock anticipated residues using results from the crop field trials and animal feeding studies; and maximum percent crop treated estimates for all crop commodities.  However, this assessment also utilized some conservative values including: tolerance levels for cotton, garlic, onion, peppermint and spearmint; default processing factors; and conservative EDWCs derived through EFED Tier 1 modeling.  EFED's Tier 1 modeling is unlikely to underestimate the concentration of bromoxynil in drinking water.  The present DEEM-FCID(TM) analysis assumes that all drinking water will contain bromoxynil at the highest acute EDWC levels modeled by EFED for groundwater or surface water.  It can be concluded that the DEEM-FCID(TM) analysis does not underestimate risk from acute exposure to bromoxynil for the general US population and all its subgroups.
 
 The chronic dietary assessment conducted with DEEM-FCID(TM) for bromoxynil is also a refined analysis.  The refinements used in this assessment includes: average field trial residues for all commodities except for spearmint and peppermint where tolerance values were used; estimated livestock anticipated residues using average percent crop treated data, average field trial residue values, and results from the animal feeding studies; and  average percent crop treated estimates for all crop commodities.  This assessment also utilized conservative EDWCs derived through EFED modeling which are unlikely to underestimate the concentration of bromoxynil in drinking water.  The present DEEM-FCID(TM) analysis assumes that all drinking water will contain bromoxynil at the highest chronic EDWC levels modeled by EFED for groundwater or surface water.  It can be concluded that the DEEM-FCID(TM) analysis does not underestimate risk from chronic or cancer exposure to bromoxynil for the general US population and all its subgroups.
 
 VIII.	Conclusions
 
The acute dietary risk assessment conducted with DEEM-FCID(TM) indicates that exposures to bromoxynil are below HED's level of concern.  The acute aggregate (food and water) dietary risk to bromoxynil is estimated to be 3.3% of the aPAD for the general US population at the 99.9[th] percentile of exposure.  For the most highly exposed population subgroup, All Infants (<1 year old), the acute risk estimate is also below HED's level of concern.  For this subgroup, the resulting acute dietary risk is 7.4% of the aPAD at the 99.9[th] percentile of exposure.  Therefore, HED is not concerned that the proposed new uses of bromoxynil could result in unacceptable risk through the potential acute dietary exposure from food and water sources.  

The chronic dietary risk assessment conducted with DEEM-FCID(TM) indicates that exposures to bromoxynil are below HED's level of concern.  The chronic aggregate (food and water) dietary risk to bromoxynil is estimated to be 0.1% of the cPAD for the general US population.  For the most highly exposed population subgroup, Children 1-2 years old, the chronic risk estimate is also below HED's level of concern.  For this subgroup, the resulting chronic dietary risk is 0.3% of the cPAD.  Therefore, HED is not concerned that the proposed new uses of bromoxynil could result in unacceptable risk through the potential chronic dietary exposure from food and water sources.  

The cancer dietary risk assessment conducted with DEEM-FCID(TM) indicates that food and water exposures to bromoxynil results in a cancer risk estimate of 1.5 x 10[-6] for the general US population where as exposure to food only results in a cancer risk estimate of 1.1 x 10[-6].

 IX.		List of Attachments
 
 1.	Attachment 1: Acute Dietary Exposure (food + water) Input File.
 2.	Attachment 2: Acute Dietary Exposure (food + water) Results File.
 3.	Attachment 3: Acute Dietary Exposure (food only) Results File.
 4.	Attachment 4: Chronic Dietary Exposure (food + water) Input File.
 5.	Attachment 5: Chronic Dietary Exposure (food + water) Results File.
 6. 	Attachment 6: Chronic Dietary Exposure (food only) Results File.
 7.	Attachment 7: Cancer Dietary Exposure (food + Water) Results File.
 8.	Attachment 8: Cancer Dietary Exposure (food only) Results File.
 9.	Attachment 9: Anticipated Residue Calculations in Livestock.
 
 
 
                                 ATTACHMENT 1
                                       
Filename: C:\Documents and Settings\cwalls\My Documents\Cassi\HED\bromoxynil\diet\bromox acute food and water.R98
Chemical: Bromoxynil
RfD(Chronic): .015 mg/kg bw/day  NOEL(Chronic): 0 mg/kg bw/day
RfD(Acute): .08 mg/kg bw/day  NOEL(Acute):  0 mg/kg bw/day Q*= .103
Date created/last modified: 03-23-2011/13:52:17/8          Program ver. 2.03
--------------------------------------------------------------------------------
  EPA    Crop                                   Def Res     Adj.Factors   Comment
  Code    Grp  Commodity Name                    (ppm)       #1    #2   
-------- ---- -------------------------------  ----------  ------ ------  -------
03001640 3    Garlic                             0.100000   1.000  0.700  tol
03001650 3    Garlic, dried                      0.100000   1.000  0.700  tol
03001651 3    Garlic, dried-babyfood             0.100000   1.000  0.700  tol
03002370 3    Onion, dry bulb                    0.100000   1.000  0.700  tol
03002371 3    Onion, dry bulb-babyfood           0.100000   1.000  0.700  tol
03002380 3    Onion, dry bulb, dried             0.100000   9.000  0.700  tol
03002381 3    Onion, dry bulb, dried-babyfood    0.100000   9.000  0.700  tol
15000250 15   Barley, pearled barley             0.010000   1.000  0.350  
15000251 15   Barley, pearled barley-babyfood    0.010000   1.000  0.350  
15000260 15   Barley, flour                      0.010000   1.000  0.350  
15000261 15   Barley, flour-babyfood             0.010000   1.000  0.350  
15000270 15   Barley, bran                       0.010000   1.000  0.350  
15001200 15   Corn, field, flour                 0.010000   1.000  0.050  
15001201 15   Corn, field, flour-babyfood        0.010000   1.000  0.050  
15001210 15   Corn, field, meal                  0.010000   1.000  0.050  
15001211 15   Corn, field, meal-babyfood         0.010000   1.000  0.050  
15001220 15   Corn, field, bran                  0.010000   1.000  0.050  
15001230 15   Corn, field, starch                0.010000   1.000  0.050  
15001231 15   Corn, field, starch-babyfood       0.010000   1.000  0.050  
15001240 15   Corn, field, syrup                 0.010000   1.500  0.050  
15001241 15   Corn, field, syrup-babyfood        0.010000   1.500  0.050  
15001250 15   Corn, field, oil                   0.010000   1.000  0.050  
15001251 15   Corn, field, oil-babyfood          0.010000   1.000  0.050  
15001260 15   Corn, pop                          0.010000   1.000  0.050  
15002310 15   Oat, bran                          0.010000   1.000  0.050  
15002320 15   Oat, flour                         0.010000   1.000  0.050  
15002321 15   Oat, flour-babyfood                0.010000   1.000  0.050  
15002330 15   Oat, groats/rolled oats            0.010000   1.000  0.050  
15002331 15   Oat, groats/rolled oats-babyfood   0.010000   1.000  0.050  
15003280 15   Rye, grain                         0.010000   1.000  0.010  
15003290 15   Rye, flour                         0.010000   1.000  0.010  
15003440 15   Sorghum, grain                     0.028000   1.000  0.025  
15003450 15   Sorghum, syrup                     0.028000   1.000  0.025  
15004010 15   Wheat, grain                       0.010000   1.000  0.350  
15004011 15   Wheat, grain-babyfood              0.010000   1.000  0.350  
15004020 15   Wheat, flour                       0.010000   1.000  0.350  
15004021 15   Wheat, flour-babyfood              0.010000   1.000  0.350  
15004030 15   Wheat, germ                        0.010000   1.000  0.350  
15004040 15   Wheat, bran                        0.010000   1.000  0.350  
18000020 18   Alfalfa, seed                      0.130000   1.000  0.025  
20001630 20   Flaxseed, oil                      0.010000   1.000  0.350  
21000440 M    Beef, meat                         0.070000   1.000  1.000  
21000441 M    Beef, meat-babyfood                0.070000   1.000  1.000  
21000450 M    Beef, meat, dried                  0.070000   1.920  1.000  
21000460 M    Beef, meat byproducts              0.430000   1.000  1.000  
21000461 M    Beef, meat byproducts-babyfood     0.430000   1.000  1.000  
21000470 M    Beef, fat                          0.130000   1.000  1.000  
21000471 M    Beef,fat-babyfood                  0.130000   1.000  1.000  
21000480 M    Beef, kidney                       0.430000   1.000  1.000  
21000490 M    Beef, liver                        0.380000   1.000  1.000  
21000491 M    Beef, liver-babyfood               0.380000   1.000  1.000  
23001690 M    Goat, meat                         0.070000   1.000  1.000  
23001700 M    Goat, meat byproducts              0.430000   1.000  1.000  
23001710 M    Goat, fat                          0.130000   1.000  1.000  
23001720 M    Goat, kidney                       0.430000   1.000  1.000  
23001730 M    Goat, liver                        0.380000   1.000  1.000  
24001890 M    Horse, meat                        0.070000   1.000  1.000  
25002900 M    Pork, meat                         0.003300   1.000  1.000  
25002901 M    Pork, meat-babyfood                0.003300   1.000  1.000  
25002910 M    Pork, skin                         0.020000   1.000  1.000  
25002920 M    Pork, meat byproducts              0.020000   1.000  1.000  
25002921 M    Pork, meat byproducts-babyfood     0.020000   1.000  1.000  
25002930 M    Pork, fat                          0.006200   1.000  1.000  
25002931 M    Pork, fat-babyfood                 0.006200   1.000  1.000  
25002940 M    Pork, kidney                       0.020000   1.000  1.000  
25002950 M    Pork, liver                        0.018000   1.000  1.000  
26003390 M    Sheep, meat                        0.070000   1.000  1.000  
26003391 M    Sheep, meat-babyfood               0.070000   1.000  1.000  
26003400 M    Sheep, meat byproducts             0.430000   1.000  1.000  
26003410 M    Sheep, fat                         0.130000   1.000  1.000  
26003411 M    Sheep, fat-babyfood                0.130000   1.000  1.000  
26003420 M    Sheep, kidney                      0.430000   1.000  1.000  
26003430 M    Sheep, liver                       0.380000   1.000  1.000  
27002220 D    Milk, fat                          0.003200   1.000  1.000  
27002221 D    Milk, fat - baby food/infant for   0.003200   1.000  1.000  
27012230 D    Milk, nonfat solids                0.003200   1.000  1.000  
27012231 D    Milk, nonfat solids-baby food/in   0.003200   1.000  1.000  
27022240 D    Milk, water                        0.003200   1.000  1.000  
27022241 D    Milk, water-babyfood/infant form   0.003200   1.000  1.000  
27032251 D    Milk, sugar (lactose)-baby food/   0.003200   1.000  1.000  
40000930 P    Chicken, meat                      0.003800   1.000  1.000  
40000931 P    Chicken, meat-babyfood             0.003800   1.000  1.000  
40000940 P    Chicken, liver                     0.048000   1.000  1.000  
40000950 P    Chicken, meat byproducts           0.048000   1.000  1.000  
40000951 P    Chicken, meat byproducts-babyfoo   0.048000   1.000  1.000  
40000960 P    Chicken, fat                       0.006100   1.000  1.000  
40000961 P    Chicken, fat-babyfood              0.006100   1.000  1.000  
40000970 P    Chicken, skin                      0.048000   1.000  1.000  
40000971 P    Chicken, skin-babyfood             0.048000   1.000  1.000  
50003820 P    Turkey, meat                       0.003800   1.000  1.000  
50003821 P    Turkey, meat-babyfood              0.003800   1.000  1.000  
50003830 P    Turkey, liver                      0.048000   1.000  1.000  
50003831 P    Turkey, liver-babyfood             0.048000   1.000  1.000  
50003840 P    Turkey, meat byproducts            0.048000   1.000  1.000  
50003841 P    Turkey, meat byproducts-babyfood   0.048000   1.000  1.000  
50003850 P    Turkey, fat                        0.006100   1.000  1.000  
50003851 P    Turkey, fat-babyfood               0.006100   1.000  1.000  
50003860 P    Turkey, skin                       0.048000   1.000  1.000  
50003861 P    Turkey, skin-babyfood              0.048000   1.000  1.000  
60003010 P    Poultry, other, meat               0.003800   1.000  1.000  
60003020 P    Poultry, other, liver              0.048000   1.000  1.000  
60003030 P    Poultry, other, meat byproducts    0.048000   1.000  1.000  
60003040 P    Poultry, other, fat                0.006100   1.000  1.000  
60003050 P    Poultry, other, skin               0.048000   1.000  1.000  
70001450 P    Egg, whole                         0.003800   1.000  1.000  
70001451 P    Egg, whole-babyfood                0.003800   1.000  1.000  
70001460 P    Egg, white                         0.003800   1.000  1.000  
70001461 P    Egg, white (solids)-babyfood       0.003800   1.000  1.000  
70001470 P    Egg, yolk                          0.003800   1.000  1.000  
70001471 P    Egg, yolk-babyfood                 0.003800   1.000  1.000  
86010000 O    Water, direct, all sources         0.011500   1.000  1.000  
86020000 O    Water, indirect, all sources       0.011500   1.000  1.000  
95001280 O    Cottonseed, oil                    1.500000   1.000  0.050  tol
95001281 O    Cottonseed, oil-babyfood           1.500000   1.000  0.050  tol
95002750 O    Peppermint                         0.100000   1.000  0.250  
95002760 O    Peppermint, oil                    0.100000   1.000  0.250  
95003520 O    Spearmint                          0.100000   1.000  0.250  
95003530 O    Spearmint, oil                     0.100000   1.000  0.250  
  

                                 ATTACHMENT 2

U.S. Environmental Protection Agency                                  Ver. 2.02
DEEM-FCID ACUTE Analysis for BROMOXYNIL                          (1994-98 data)
Residue file: bromox acute food and water.R98         Adjustment factor #2 used.
Analysis Date: 03-23-2011/14:02:59    Residue file dated: 03-23-2011/13:56:53/8
Acute Pop Adjusted Dose (aPAD) varies with population; see individual reports
Daily totals for food and foodform consumption used.
Run Comment: ""
===============================================================================

Summary calculations (per capita):

                    95th Percentile      99th Percentile      99.9th Percentile
                   Exposure   % aPAD    Exposure   % aPAD    Exposure   % aPAD 
                  ---------- --------  ---------- --------  ---------- --------
U.S. Population:
                    0.000900     1.12    0.001500     1.88    0.002639     3.30 
All infants:
                    0.002374     2.97    0.003338     4.17    0.005892     7.36 
Children 1-2 yrs:
                    0.001570     1.96    0.002305     2.88    0.003714     4.64 
Children 3-5 yrs:
                    0.001425     1.78    0.002142     2.68    0.003527     4.41 
Children 6-12 yrs:
                    0.001008     1.26    0.001475     1.84    0.002151     2.69 
Youth 13-19 yrs:
                    0.000700     0.88    0.001142     1.43    0.002507     3.13 
Adults 20-49 yrs:
                    0.000756     0.95    0.001164     1.45    0.001965     2.46 
Adults 50+ yrs:
                    0.000654     0.82    0.000961     1.20    0.001482     1.85 
Females 13-49 yrs:
                  0.000728     1.82    0.001091     2.73    0.001756     4.39

                                 ATTACHMENT 3

U.S. Environmental Protection Agency                                  Ver. 2.02
DEEM-FCID ACUTE Analysis for BROMOXYNIL                          (1994-98 data)
Residue file: bromox acute food only.R98              Adjustment factor #2 used.
Analysis Date: 03-23-2011/14:04:17    Residue file dated: 03-23-2011/13:57:35/8
Acute Pop Adjusted Dose (aPAD) varies with population; see individual reports
Daily totals for food and foodform consumption used.
Run Comment: ""
===============================================================================

Summary calculations (per capita):

                    95th Percentile      99th Percentile      99.9th Percentile
                   Exposure   % aPAD    Exposure   % aPAD    Exposure   % aPAD 
                  ---------- --------  ---------- --------  ---------- --------
U.S. Population:
                    0.000429     0.54    0.000788     0.99    0.001504     1.88 
All infants:
                    0.000472     0.59    0.001011     1.26    0.002311     2.89 
Children 1-2 yrs:
                    0.000950     1.19    0.001439     1.80    0.002472     3.09 
Children 3-5 yrs:
                    0.000815     1.02    0.001330     1.66    0.002682     3.35 
Children 6-12 yrs:
                    0.000563     0.70    0.000901     1.13    0.001924     2.41 
Youth 13-19 yrs:
                    0.000382     0.48    0.000654     0.82    0.001503     1.88 
Adults 20-49 yrs:
                    0.000340     0.43    0.000561     0.70    0.001165     1.46 
Adults 50+ yrs:
                    0.000266     0.33    0.000458     0.57    0.001134     1.42 
Females 13-49 yrs:
                  0.000296     0.74    0.000493     1.23    0.000912     2.28 ATTACHMENT 4
                                       
Filename: C:\Documents and Settings\cwalls\My Documents\Cassi\HED\bromoxynil\diet\bromox chronic food and water.R98
Chemical: Bromoxynil
RfD(Chronic): .015 mg/kg bw/day  NOEL(Chronic): 0 mg/kg bw/day
RfD(Acute): .08 mg/kg bw/day  NOEL(Acute):  0 mg/kg bw/day Q*= .103
Date created/last modified: 03-23-2011/13:54:57/8          Program ver. 2.03
--------------------------------------------------------------------------------
  EPA    Crop                                   Def Res     Adj.Factors   Comment
  Code    Grp  Commodity Name                    (ppm)       #1    #2   
-------- ---- -------------------------------  ----------  ------ ------  -------
03001640 3    Garlic                             0.010000   1.000  0.500  
03001650 3    Garlic, dried                      0.010000   1.000  0.500  
03001651 3    Garlic, dried-babyfood             0.010000   1.000  0.500  
03002370 3    Onion, dry bulb                    0.010000   1.000  0.550  
03002371 3    Onion, dry bulb-babyfood           0.010000   1.000  0.550  
03002380 3    Onion, dry bulb, dried             0.010000   9.000  0.550  
03002381 3    Onion, dry bulb, dried-babyfood    0.010000   9.000  0.550  
15000250 15   Barley, pearled barley             0.010000   1.000  0.200  
15000251 15   Barley, pearled barley-babyfood    0.010000   1.000  0.200  
15000260 15   Barley, flour                      0.010000   1.000  0.200  
15000261 15   Barley, flour-babyfood             0.010000   1.000  0.200  
15000270 15   Barley, bran                       0.010000   1.000  0.200  
15001200 15   Corn, field, flour                 0.010000   1.000  0.025  
15001201 15   Corn, field, flour-babyfood        0.010000   1.000  0.025  
15001210 15   Corn, field, meal                  0.010000   1.000  0.025  
15001211 15   Corn, field, meal-babyfood         0.010000   1.000  0.025  
15001220 15   Corn, field, bran                  0.010000   1.000  0.025  
15001230 15   Corn, field, starch                0.010000   1.000  0.025  
15001231 15   Corn, field, starch-babyfood       0.010000   1.000  0.025  
15001240 15   Corn, field, syrup                 0.010000   1.500  0.025  
15001241 15   Corn, field, syrup-babyfood        0.010000   1.500  0.025  
15001250 15   Corn, field, oil                   0.010000   1.000  0.025  
15001251 15   Corn, field, oil-babyfood          0.010000   1.000  0.025  
15001260 15   Corn, pop                          0.010000   1.000  0.025  
15002310 15   Oat, bran                          0.010000   1.000  0.050  
15002320 15   Oat, flour                         0.010000   1.000  0.050  
15002321 15   Oat, flour-babyfood                0.010000   1.000  0.050  
15002330 15   Oat, groats/rolled oats            0.010000   1.000  0.050  
15002331 15   Oat, groats/rolled oats-babyfood   0.010000   1.000  0.050  
15003280 15   Rye, grain                         0.010000   1.000  0.010  
15003290 15   Rye, flour                         0.010000   1.000  0.010  
15003440 15   Sorghum, grain                     0.028000   1.000  0.025  
15003450 15   Sorghum, syrup                     0.028000   1.000  0.025  
15004010 15   Wheat, grain                       0.010000   1.000  0.150  
15004011 15   Wheat, grain-babyfood              0.010000   1.000  0.150  
15004020 15   Wheat, flour                       0.010000   1.000  0.150  
15004021 15   Wheat, flour-babyfood              0.010000   1.000  0.150  
15004030 15   Wheat, germ                        0.010000   1.000  0.150  
15004040 15   Wheat, bran                        0.010000   1.000  0.150  
18000020 18   Alfalfa, seed                      0.130000   1.000  0.010  
20001630 20   Flaxseed, oil                      0.010000   1.000  0.350  
21000440 M    Beef, meat                         0.001300   1.000  1.000  
21000441 M    Beef, meat-babyfood                0.001300   1.000  1.000  
21000450 M    Beef, meat, dried                  0.001300   1.920  1.000  
21000460 M    Beef, meat byproducts              0.008100   1.000  1.000  
21000461 M    Beef, meat byproducts-babyfood     0.008100   1.000  1.000  
21000470 M    Beef, fat                          0.002400   1.000  1.000  
21000471 M    Beef,fat-babyfood                  0.002400   1.000  1.000  
21000480 M    Beef, kidney                       0.008100   1.000  1.000  
21000490 M    Beef, liver                        0.007000   1.000  1.000  
21000491 M    Beef, liver-babyfood               0.007000   1.000  1.000  
23001690 M    Goat, meat                         0.001300   1.000  1.000  
23001700 M    Goat, meat byproducts              0.008100   1.000  1.000  
23001710 M    Goat, fat                          0.002400   1.000  1.000  
23001720 M    Goat, kidney                       0.008100   1.000  1.000  
23001730 M    Goat, liver                        0.007000   1.000  1.000  
24001890 M    Horse, meat                        0.001300   1.000  1.000  
25002900 M    Pork, meat                         0.000083   1.000  1.000  
25002901 M    Pork, meat-babyfood                0.000083   1.000  1.000  
25002910 M    Pork, skin                         0.000150   1.000  1.000  
25002920 M    Pork, meat byproducts              0.000510   1.000  1.000  
25002921 M    Pork, meat byproducts-babyfood     0.000510   1.000  1.000  
25002930 M    Pork, fat                          0.000150   1.000  1.000  
25002931 M    Pork, fat-babyfood                 0.000150   1.000  1.000  
25002940 M    Pork, kidney                       0.000510   1.000  1.000  
25002950 M    Pork, liver                        0.000440   1.000  1.000  
26003390 M    Sheep, meat                        0.001300   1.000  1.000  
26003391 M    Sheep, meat-babyfood               0.001300   1.000  1.000  
26003400 M    Sheep, meat byproducts             0.008100   1.000  1.000  
26003410 M    Sheep, fat                         0.002400   1.000  1.000  
26003411 M    Sheep, fat-babyfood                0.002400   1.000  1.000  
26003420 M    Sheep, kidney                      0.008100   1.000  1.000  
26003430 M    Sheep, liver                       0.007000   1.000  1.000  
27002220 D    Milk, fat                          0.000540   1.000  1.000  
27002221 D    Milk, fat - baby food/infant for   0.000540   1.000  1.000  
27012230 D    Milk, nonfat solids                0.000540   1.000  1.000  
27012231 D    Milk, nonfat solids-baby food/in   0.000540   1.000  1.000  
27022240 D    Milk, water                        0.000540   1.000  1.000  
27022241 D    Milk, water-babyfood/infant form   0.000540   1.000  1.000  
27032251 D    Milk, sugar (lactose)-baby food/   0.000540   1.000  1.000  
40000930 P    Chicken, meat                      0.000078   1.000  1.000  
40000931 P    Chicken, meat-babyfood             0.000078   1.000  1.000  
40000940 P    Chicken, liver                     0.000990   1.000  1.000  
40000950 P    Chicken, meat byproducts           0.000990   1.000  1.000  
40000951 P    Chicken, meat byproducts-babyfoo   0.000990   1.000  1.000  
40000960 P    Chicken, fat                       0.000130   1.000  1.000  
40000961 P    Chicken, fat-babyfood              0.000130   1.000  1.000  
40000970 P    Chicken, skin                      0.000130   1.000  1.000  
40000971 P    Chicken, skin-babyfood             0.000130   1.000  1.000  
50003820 P    Turkey, meat                       0.000078   1.000  1.000  
50003821 P    Turkey, meat-babyfood              0.000078   1.000  1.000  
50003830 P    Turkey, liver                      0.000990   1.000  1.000  
50003831 P    Turkey, liver-babyfood             0.000990   1.000  1.000  
50003840 P    Turkey, meat byproducts            0.000990   1.000  1.000  
50003841 P    Turkey, meat byproducts-babyfood   0.000990   1.000  1.000  
50003850 P    Turkey, fat                        0.000130   1.000  1.000  
50003851 P    Turkey, fat-babyfood               0.000130   1.000  1.000  
50003860 P    Turkey, skin                       0.000130   1.000  1.000  
50003861 P    Turkey, skin-babyfood              0.000130   1.000  1.000  
60003010 P    Poultry, other, meat               0.000078   1.000  1.000  
60003020 P    Poultry, other, liver              0.000990   1.000  1.000  
60003030 P    Poultry, other, meat byproducts    0.000990   1.000  1.000  
60003040 P    Poultry, other, fat                0.000130   1.000  1.000  
60003050 P    Poultry, other, skin               0.000130   1.000  1.000  
70001450 P    Egg, whole                         0.000078   1.000  1.000  
70001451 P    Egg, whole-babyfood                0.000078   1.000  1.000  
70001460 P    Egg, white                         0.000078   1.000  1.000  
70001461 P    Egg, white (solids)-babyfood       0.000078   1.000  1.000  
70001470 P    Egg, yolk                          0.000078   1.000  1.000  
70001471 P    Egg, yolk-babyfood                 0.000078   1.000  1.000  
86010000 O    Water, direct, all sources         0.000190   1.000  1.000  
86020000 O    Water, indirect, all sources       0.000190   1.000  1.000  
95001280 O    Cottonseed, oil                    0.300000   1.000  0.025  
95001281 O    Cottonseed, oil-babyfood           0.300000   1.000  0.025  
95002750 O    Peppermint                         0.100000   1.000  0.250  
95002760 O    Peppermint, oil                    0.100000   1.000  0.250  
95003520 O    Spearmint                          0.100000   1.000  0.250  
95003530 O    Spearmint, oil                     0.100000   1.000  0.250  
                                 ATTACHMENT 5

U.S. Environmental Protection Agency                                 Ver. 2.00
DEEM-FCID Chronic analysis for BROMOXYNIL                       (1994-98 data)
Residue file name: C:\Documents and Settings\cwalls\My Documents\Cassi\HED\bromoxynil\diet\bromox chronic food and water.R98
                                                     Adjustment factor #2 used.
Analysis Date 03-23-2011/13:59:49     Residue file dated: 03-23-2011/13:58:19/8
Reference dose (RfD, Chronic) = .015 mg/kg bw/day
===============================================================================
                    Total exposure by population subgroup
-------------------------------------------------------------------------------

                                                    Total Exposure
                                         -----------------------------------
          Population                         mg/kg             Percent of   
           Subgroup                       body wt/day             Rfd       
--------------------------------------   -------------       ---------------
U.S. Population (total)                     0.000014                 0.1%

U.S. Population (spring season)             0.000014                 0.1%
U.S. Population (summer season)             0.000014                 0.1%
U.S. Population (autumn season)             0.000014                 0.1%
U.S. Population (winter season)             0.000014                 0.1%

Northeast region                            0.000014                 0.1%
Midwest region                              0.000015                 0.1%
Southern region                             0.000013                 0.1%
Western region                              0.000015                 0.1%

Hispanics                                   0.000016                 0.1%
Non-hispanic whites                         0.000014                 0.1%
Non-hispanic blacks                         0.000014                 0.1%
Non-hisp/non-white/non-black                0.000016                 0.1%

All infants (< 1 year)                      0.000024                 0.2%
Nursing infants                             0.000009                 0.1%
Non-nursing infants                         0.000030                 0.2%
Children 1-6  yrs                           0.000034                 0.2%
Children 7-12 yrs                           0.000020                 0.1%

Females 13-19 (not preg or nursing)         0.000011                 0.1%
Females 20+ (not preg or nursing)           0.000010                 0.1%
Females 13-50 yrs                           0.000012                 0.1%
Females 13+ (preg/not nursing)              0.000013                 0.1%
Females 13+ (nursing)                       0.000016                 0.1%

Males 13-19 yrs                             0.000014                 0.1%
Males 20+ yrs                               0.000012                 0.1%
Seniors 55+                                 0.000010                 0.1%

Children 1-2 yrs                            0.000040                 0.3%
Children 3-5 yrs                            0.000032                 0.2%
Children 6-12 yrs                           0.000021                 0.1%
Youth 13-19 yrs                             0.000013                 0.1%
Adults 20-49 yrs                            0.000011                 0.1%
Adults 50+ yrs                              0.000010                 0.1%
Females 13-49 yrs                           0.000011                 0.1%

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

                                 ATTACHMENT 6

U.S. Environmental Protection Agency                                 Ver. 2.00
DEEM-FCID Chronic analysis for BROMOXYNIL                       (1994-98 data)
Residue file name: C:\Documents and Settings\cwalls\My Documents\Cassi\HED\bromoxynil\diet\bromox chronic food only.R98
                                                     Adjustment factor #2 used.
Analysis Date 03-23-2011/14:01:13     Residue file dated: 03-23-2011/13:56:04/8
Reference dose (RfD, Chronic) = .015 mg/kg bw/day
===============================================================================
                    Total exposure by population subgroup
-------------------------------------------------------------------------------

                                                    Total Exposure
                                         -----------------------------------
          Population                         mg/kg             Percent of   
           Subgroup                       body wt/day             Rfd       
--------------------------------------   -------------       ---------------
U.S. Population (total)                     0.000010                 0.1%

U.S. Population (spring season)             0.000010                 0.1%
U.S. Population (summer season)             0.000010                 0.1%
U.S. Population (autumn season)             0.000011                 0.1%
U.S. Population (winter season)             0.000010                 0.1%

Northeast region                            0.000010                 0.1%
Midwest region                              0.000011                 0.1%
Southern region                             0.000009                 0.1%
Western region                              0.000011                 0.1%

Hispanics                                   0.000012                 0.1%
Non-hispanic whites                         0.000010                 0.1%
Non-hispanic blacks                         0.000010                 0.1%
Non-hisp/non-white/non-black                0.000011                 0.1%

All infants (< 1 year)                      0.000011                 0.1%
Nursing infants                             0.000004                 0.0%
Non-nursing infants                         0.000014                 0.1%
Children 1-6  yrs                           0.000028                 0.2%
Children 7-12 yrs                           0.000016                 0.1%

Females 13-19 (not preg or nursing)         0.000008                 0.1%
Females 20+ (not preg or nursing)           0.000006                 0.0%
Females 13-50 yrs                           0.000008                 0.1%
Females 13+ (preg/not nursing)              0.000009                 0.1%
Females 13+ (nursing)                       0.000010                 0.1%

Males 13-19 yrs                             0.000011                 0.1%
Males 20+ yrs                               0.000008                 0.1%
Seniors 55+                                 0.000006                 0.0%

Children 1-2 yrs                            0.000034                 0.2%
Children 3-5 yrs                            0.000026                 0.2%
Children 6-12 yrs                           0.000017                 0.1%
Youth 13-19 yrs                             0.000010                 0.1%
Adults 20-49 yrs                            0.000008                 0.1%
Adults 50+ yrs                              0.000006                 0.0%
Females 13-49 yrs                           0.000007                 0.0%

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

                                 ATTACHMENT 7
                                       
U.S. Environmental Protection Agency                                 Ver. 2.00
DEEM-FCID Chronic analysis for BROMOXYNIL                       (1994-98 data)
Residue file name: C:\Documents and Settings\cwalls\My Documents\Cassi\HED\bromoxynil\diet\bromox chronic food and water.R98
                                                     Adjustment factor #2 used.
Analysis Date 03-23-2011/14:00:35     Residue file dated: 03-23-2011/13:58:19/8
Q* = 0.103 
===============================================================================
                    Total exposure by population subgroup
-------------------------------------------------------------------------------

                                                    Total Exposure
                                         -----------------------------------
          Population                         mg/kg         Lifetime risk
           Subgroup                       body wt/day       (Q*= .103)
--------------------------------------   -------------     -------------
U.S. Population (total)                     0.000014         1.47E-06

U.S. Population (spring season)             0.000014         1.46E-06
U.S. Population (summer season)             0.000014         1.47E-06
U.S. Population (autumn season)             0.000014         1.48E-06
U.S. Population (winter season)             0.000014         1.45E-06

Northeast region                            0.000014         1.42E-06
Midwest region                              0.000015         1.53E-06
Southern region                             0.000013         1.37E-06
Western region                              0.000015         1.59E-06

Hispanics                                   0.000016         1.67E-06
Non-hispanic whites                         0.000014         1.44E-06
Non-hispanic blacks                         0.000014         1.41E-06
Non-hisp/non-white/non-black                0.000016         1.64E-06

All infants (< 1 year)                      0.000024         2.52E-06
Nursing infants                             0.000009         8.93E-07
Non-nursing infants                         0.000030         3.13E-06
Children 1-6  yrs                           0.000034         3.48E-06
Children 7-12 yrs                           0.000020         2.04E-06

Females 13-19 (not preg or nursing)         0.000011         1.15E-06
Females 20+ (not preg or nursing)           0.000010         1.06E-06
Females 13-50 yrs                           0.000012         1.21E-06
Females 13+ (preg/not nursing)              0.000013         1.32E-06
Females 13+ (nursing)                       0.000016         1.60E-06

Males 13-19 yrs                             0.000014         1.44E-06
Males 20+ yrs                               0.000012         1.19E-06
Seniors 55+                                 0.000010         1.04E-06

Children 1-2 yrs                            0.000040         4.10E-06
Children 3-5 yrs                            0.000032         3.28E-06
Children 6-12 yrs                           0.000021         2.16E-06
Youth 13-19 yrs                             0.000013         1.30E-06
Adults 20-49 yrs                            0.000011         1.17E-06
Adults 50+ yrs                              0.000010         1.04E-06
Females 13-49 yrs                           0.000011         1.11E-06

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

                                 ATTACHMENT 8

U.S. Environmental Protection Agency                                 Ver. 2.00
DEEM-FCID Chronic analysis for BROMOXYNIL                       (1994-98 data)
Residue file name: C:\Documents and Settings\cwalls\My Documents\Cassi\HED\bromoxynil\diet\bromox chronic food only.R98
                                                     Adjustment factor #2 used.
Analysis Date 03-23-2011/14:01:13     Residue file dated: 03-23-2011/13:56:04/8
Reference dose (RfD, Chronic) = .015 mg/kg bw/day
===============================================================================
                    Total exposure by population subgroup
-------------------------------------------------------------------------------

                                                    Total Exposure
                                         -----------------------------------
          Population                         mg/kg             Percent of   
           Subgroup                       body wt/day             Rfd       
--------------------------------------   -------------       ---------------
U.S. Population (total)                     0.000010                 0.1%

U.S. Population (spring season)             0.000010                 0.1%
U.S. Population (summer season)             0.000010                 0.1%
U.S. Population (autumn season)             0.000011                 0.1%
U.S. Population (winter season)             0.000010                 0.1%

Northeast region                            0.000010                 0.1%
Midwest region                              0.000011                 0.1%
Southern region                             0.000009                 0.1%
Western region                              0.000011                 0.1%

Hispanics                                   0.000012                 0.1%
Non-hispanic whites                         0.000010                 0.1%
Non-hispanic blacks                         0.000010                 0.1%
Non-hisp/non-white/non-black                0.000011                 0.1%

All infants (< 1 year)                      0.000011                 0.1%
Nursing infants                             0.000004                 0.0%
Non-nursing infants                         0.000014                 0.1%
Children 1-6  yrs                           0.000028                 0.2%
Children 7-12 yrs                           0.000016                 0.1%

Females 13-19 (not preg or nursing)         0.000008                 0.1%
Females 20+ (not preg or nursing)           0.000006                 0.0%
Females 13-50 yrs                           0.000008                 0.1%
Females 13+ (preg/not nursing)              0.000009                 0.1%
Females 13+ (nursing)                       0.000010                 0.1%

Males 13-19 yrs                             0.000011                 0.1%
Males 20+ yrs                               0.000008                 0.1%
Seniors 55+                                 0.000006                 0.0%

Children 1-2 yrs                            0.000034                 0.2%
Children 3-5 yrs                            0.000026                 0.2%
Children 6-12 yrs                           0.000017                 0.1%
Youth 13-19 yrs                             0.000010                 0.1%
Adults 20-49 yrs                            0.000008                 0.1%
Adults 50+ yrs                              0.000006                 0.0%
Females 13-49 yrs                           0.000007                 0.0%

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

                                 ATTACHMENT 9
                                       
Dairy Cattle and Poultry Feeding Studies	

Cattle and poultry feeding studies were previously reviewed (DP Number 232957, G. F. Kramer, 3/11/97).  Results of the feeding studies with both feeding levels and residues reported as bromoxynil per se (DP Number 239914, C. Swartz, 1/20/98) are reported below:

           Table 1.   Average Bromoxynil Residues in Cattle Tissues
Feeding Level (ppm)
                       Average Bromoxynil Residues (ppm)

                                     Milk
                                     Liver
                                    Kidney
                                      Fat
                                    Muscle
                                      4.2
                                     0.05
                                     1.97
                                     2.26
                                     0.68
                                     0.37
                                     12.6
                                     0.14
                                     4.04
                                     5.89
                                     2.11
                                     0.86
                                     42.0
                                     0.48
                                     10.65
                                     16.26
                                     4.75
                                     2.59

           Table 2.  Average Bromoxynil Residues in Poultry Tissues
Feeding Level (ppm)
                       Average Bromoxynil Residues (ppm)

                                     Liver
                                    Muscle
                                Skin & Fat
                                     0.07
                                     0.063
                                 Not analyzed
                                 Not analyzed
                                     0.21
                                     0.083
                                   <0.05
                                   <0.05
                                     0.70
                                     0.21
                                     0.05
                                     0.08
[1]Residues in eggs were not detectable (<0.05 ppm) at the highest feeding level (0.70 ppm).

Calculation of Anticipated Residues for Livestock Commodities - Chronic and Cancer Assessments

             Table 3.  Livestock Feed Items for Chronic Assessment
                                   Commodity
                                 Recommended/
                         Established  Tolerance (ppm)
                       Average Field Trial Residue (ppm)
                                % Crop Treated
                                   (average)
                           Anticipated Residue (ppm)
Alfalfa, meal
                                     --[1]
                                     0.13
                                     <1
                                    0.0013
Barley, grain
                                     0.05
                                     0.01
                                      20
                                     0.002
Barley, hay
                                      9.0
                                     0.43
                                      20
                                     0.086
Cotton, gin byproducts
                                      7.0
                                      3.2
                                    <2.5
                                     0.08
Cotton,  meal
                                     --[2]
                                     0.10
                                    <2.5
                                    0.0025
Cotton, undelinted seed
                                      1.5
                                     0.30
                                    <2.5
                                    0.0075
Sorghum, grain, grain
                                      0.2
                                     0.028
                                    <2.5
                                    0.0007
1 Residues in alfalfa hay are used for alfalfa meal.  In this table, the alfalfa hay tolerance is used for alfalfa meal.
[2] No separate tolerance is established for cotton  meal.  A 0.3x reduction  factor is applied to undelinted cotton seed residues to obtain average residues in cotton  meal.

Table 4.  Bromoxynil Dietary Contributions for Chronic Assessment using Average Residues from Field Trials as Anticipated Residues (AR)
                                       
                                   %  Diet 
                          Dietary Contributions (ppm)
                                   Feedstuff
                                     Type
                                  AR, ppm[1]
                                 % Dry Matter
                                     Beef
                                     Dairy
                                    Poultry
                                     Swine
                                     Beef 
                                    Diary 
                                  Poultry[2] 
                                   Swine[2]
                                       
Barley, hay
                                       R
                                     0.086
                                      88
                                      10
                                      45
                                      --
                                      --
                                    0.0098
                                     0.044
                                      --
                                      --
Cotton byproducts
                                       R
                                     0.08
                                      90
                                       5
                                      --
                                      --
                                      --
                                    0.0044
                                      --
                                      --
                                      --
                                       
Grain sorghum, grain
                                      CC
                                    0.0007
                                      86
                                      40
                                      45
                                      75
                                      80
                                    0.00032
                                    0.00036
                                    0.00052
                                    0.00056
Barley grain
                                      CC
                                     0.002
                                      88
                                      40
                                      --
                                      --
                                       5
                                       
                                      --
                                      --
                                       
                                       
Cotton, undelinted seed
                                      PC
                                    0.0075
                                      88
                                      Nu
                                      10
                                      Nu
                                      Nu
                                      --
                                    0.00085
                                      --
                                      --
Cotton meal
                                      PC
                                    0.0025
                                      89
                                       5
                                      --
                                      20
                                      15
                                    0.00014
                                      --
                                    0.00050
                                    0.00038
Alfalfa meal
                                      PC
                                    0.0013
                                      89
                                      Nu
                                      --
                                       5
                                      --
                                      --
                                      --
                                   0.000065
                                      --
                                       
Totals

                                      100
                                      100
                                      100
                                      100
                                     0.015
                                     0.045
                                    0.0011
                                    0.00094
[1]The anticipated residues for livestock feed items are the average residues from field trials.
2 Poultry and swine calculations do not include division by percent dry matter.

Calculation of Anticipated Residues for Livestock Commodities  -  Acute Assessment

Table 5.  Livestock Feed Items for Acute Analysis for Beef Cattle, Poultry, and Swine
                                   Commodity
                                 Recommended/
                         Established  Tolerance (ppm)
                         Anticipated Residue (ppm)[1]
Alfalfa, meal[2]
                                     --[4]
                                     0.25
Barley, grain[3]
                                     0.05
                                     0.01
Barley, hay[2]
                                      9.0
                                      3.7
Cotton, gin byproducts[2]
                                      7.0
                                      6.4
Cotton,  meal[3]
                                     --[5]
                                     0.10
Cotton, undelinted seed[3]
                                      1.5
                                     0.30
Sorghum, grain, grain[3]
                                      0.2
                                     0.028
1 In an acute analysis for beef cattle, poultry, and swine, average field trial residues can be used for blended commodities and the highest average field trial (HAFT) values can be used for partially blended and nonblended commodities (Dietary Exposure Science Advisory Council, September 2009, Dietary Exposure Analysis).
[2] Partially blended (Stasikowski, M., 8/20/99, Classification of Food Forms with Respect to Level of Blending.  HED Standard Operating Procedure 99.6)
3 Blended (SOP 99.6)
[4/]Alfalfa meal is included in the livestock diet using the alfalfa hay tolerance (OPPTS 860.1000).  The alfalfa hay tolerance is 0.5 ppm. 
[5]The cotton, undelinted seed tolerance is 1.5 ppm and is adequate to cover residues in cotton meal.

Table 6.  Bromoxynil Dietary Contributions for Acute Assessment for Beef Cattle, Poultry, and Swine Using Average Field Trial Residues for Blended Commodities and the Highest Average Field Trial (HAFT) Values for Partially Blended and Nonblended Commodities
                                       
                                  %  Diet [b]
                          Dietary Contributions (ppm)
                                   Feedstuff
                                     Type
                                  AR, ppm[1]
                                 % Dry Matter
                                     Beef
                                    Poultry
                                     Swine
                                     Beef 
                                   Poultry 
                                    Swine 
                                       
Barley, hay
                                       R
                                      3.7
                                      88
                                      10
                                      --
                                      --
                                     0.42
                                      --
                                      --
Cotton, gin  byproducts
                                       R
                                      6.4
                                      90
                                       5
                                      --
                                      --
                                      --
                                     0.36
                                      --
                                      --
                                       
Grain sorghum, grain
                                      CC
                                     0.028
                                      86
                                      40
                                      75
                                      80
                                     0.013
                                     0.021
                                     0.022
Barley grain
                                      CC
                                     0.01
                                      88
                                      40
                                      --
                                       5
                                    0.0045
                                      --
                                    0.0005
                                       
Cotton, undelinted seed
                                      PC
                                     0.30
                                      88
                                      Nu
                                      Nu
                                      Nu
                                      --
                                      --
                                      --
Cotton meal
                                      PC
                                     0.10
                                      89
                                       5
                                      20
                                      15
                                    0.0056
                                     0.02
                                     0.015
Alfalfa meal
                                      PC
                                     0.25
                                      89
                                      Nu
                                       5
                                      --
                                      --
                                     0.012
                                      --
                                       
Totals

                                      100
                                      100
                                      100
                                     0.80
                                     0.053
                                     0.038

     Table 7.  Livestock Feed Items for Acute Assessment for Dairy Cattle
                                   Commodity
                                 Recommended/
                         Established  Tolerance (ppm)
                         Anticipated Residue (ppm)[1]
Alfalfa, meal
                                     --[2]
                                     0.13
Barley, grain
                                     0.05
                                     0.01
Barley, hay
                                      9.0
                                     0.43
Cotton, gin byproducts
                                      7.0
                                      3.2
Cotton,  meal
                                     --[3]
                                     0.10
Cotton, undelinted seed
                                      1.5
                                     0.30
Sorghum, grain, grain
                                      0.2
                                     0.028
1 In an acute analysis for dairy cattle, tolerance level residues may be replaced with average field trial residues for blended, nonblended, and partially blended feed items commodities (Dietary Exposure Science Advisory Council, September 2009, Dietary Exposure Analysis).
[2/]Alfalfa meal is included in the livestock diet using the alfalfa hay tolerance (OPPTS 860.1000).  The alfalfa hay tolerance is 0.5 ppm. 
[3]The cotton, undelinted seed tolerance is 1.5 ppm and is adequate to cover residues in cotton meal.

Table 8.  Bromoxynil Dietary Contributions for Acute Assessment for Dairy Cattle using Average Field Trial Residues for Blended, Nonblended, and Partially Blended Commodities
                                       
                                  %  Diet [b]
                          Dietary Contributions (ppm)
                                   Feedstuff
                                     Type
                                  AR, ppm[1]
                                 % Dry Matter
                                     Dairy
                                    Diary 
                                       
Barley, hay
                                       R
                                     0.43
                                      88
                                      45
                                     0.22
Cotton, gin  byproducts
                                       R
                                      3.2
                                      90
                                      --
                                      --
                                       
Grain sorghum, grain
                                      CC
                                     0.028
                                      86
                                      45
                                     0.015
Barley grain
                                      CC
                                     0.01
                                      88
                                      --
                                      --
                                       
Cotton, undelinted seed
                                      PC
                                     0.30
                                      88
                                      10
                                     0.034
Cotton meal
                                      PC
                                     0.10
                                      89
                                      --
                                      --
Alfalfa meal
                                      PC
                                     0.13
                                      89
                                      --
                                      --
                                       
Totals

                                      100
                                     0.269

Anticipated Residues in Meat and Milk for Use in DEEM

Chronic Anticipated Residues

Table 9.    Transfer Coefficients and Chronic Anticipated Residues of Bromoxynil  in Dairy Cattle Commodities
Matrix
                                 Feeding Level
                                     (ppm)
                   Maximum Residues at Feeding Level  (ppm)
                                   Transfer
                                Coefficient [1]
                        Calculated Dietary Burden (ppm)
                   Calculated Anticipated Residues (ppm)[2]
Milk
                                      4.2
                                     0.05
                                     0.012
                                     0.045
                                    0.00054
[1]  Obtained by dividing the  maximum residues at the feeding level by the feeding level.
2  Obtained by multiplying the transfer coefficient by the calculated dietary burden.

Table 10.    Transfer Coefficients and Chronic Anticipated Residues of Bromoxynil  in Beef Cattle Commodities
Matrix
                                 Feeding Level
                                     (ppm)
                   Maximum Residues at Feeding Level  (ppm)
                                   Transfer
                                Coefficient [1]
                        Calculated Dietary Burden (ppm)
                   Calculated Anticipated Residues (ppm)[2]
Fat
                                      4.2
                                     0.68
                                     0.16
                                     0.015
                                    0.0024
Kidney
                                       
                                     2.26
                                     0.54
                                       
                                    0.0081
Liver
                                       
                                     1.97
                                     0.47
                                       
                                    0.0070
 Muscle
                                       
                                     0.37
                                     0.088
                                       
                                    0.0013
[1]  Obtained by dividing the  maximum residues at the feeding level by the feeding level.
2  Obtained by multiplying the transfer coefficient by the calculated dietary burden.

Table 11.    Transfer Coefficients and Chronic Anticipated Residues of Bromoxynil  in Poultry Commodities
Matrix
                                 Feeding Level
                                     (ppm)
                   Maximum Residues at Feeding Level  (ppm)
                                   Transfer
                                Coefficient [1]
                        Calculated Dietary Burden (ppm)
                   Calculated Anticipated Residues (ppm)[3]
Eggs
                                     0.70
                                  <0.05[2]
                                     0.071
                                    0.0011
                                   0.000078
Skin/Fat
                                     0.70
                                     0.08
                                     0.11
                                       
                                    0.00013
Liver
                                     0.07
                                     0.063
                                     0.90
                                       
                                    0.00099
Muscle
                                     0.70
                                     0.05
                                     0.071
                                       
                                   0.000078
[1]  Obtained by dividing the  maximum residues at the feeding level by the feeding level.
2  Residues in eggs were <0.05 ppm at the highest feeding level (1.0 ppm).
3  Obtained by multiplying the transfer coefficient by the calculated dietary burden.

Table 12.    Transfer Coefficients and Chronic Anticipated Residues of Bromoxynil  in Swine Commodities
Matrix
                                 Feeding Level
                                     (ppm)
                   Maximum Residues at Feeding Level  (ppm)
                                   Transfer
                                Coefficient [1]
                        Calculated Dietary Burden (ppm)
                   Calculated Anticipated Residues (ppm)[2]
Fat
                                      4.2
                                     0.68
                                     0.16
                                    0.00094
                                    0.00015
Kidney
                                       
                                     2.26
                                     0.54
                                       
                                    0.00051
Liver
                                       
                                     1.97
                                     0.47
                                       
                                    0.00044
Muscle
                                       
                                     0.37
                                     0.088
                                       
                                   0.000083
[1]  Obtained by dividing the  maximum residues at the feeding level by the feeding level.
2  Obtained by multiplying the transfer coefficient by the calculated dietary burden.

Acute Anticipated Residues

Table 13.    Transfer Coefficients and Acute Anticipated Residues of Bromoxynil  in Dairy Cattle (Milk) 
Matrix
                                 Feeding Level
                                     (ppm)
                   Maximum Residues at Feeding Level  (ppm)
                                   Transfer
                                Coefficient [1]
                        Calculated Dietary Burden (ppm)
                   Calculated Anticipated Residues (ppm)[2]
Milk
                                      4.2
                                     0.05
                                     0.012
                                     0.269
                                    0.0032
[1]  Obtained by dividing the  maximum residues at the feeding level by the feeding level.
2  Obtained by multiplying the transfer coefficient by the calculated dietary burden.

Table 14.    Transfer Coefficients and Acute Anticipated Residues of Bromoxynil  in Beef Cattle Commodities
Matrix
                                 Feeding Level
                                     (ppm)
                   Maximum Residues at Feeding Level  (ppm)
                                   Transfer
                                Coefficient [1]
                        Calculated Dietary Burden (ppm)
                   Calculated Anticipated Residues (ppm)[2]
Fat
                                      4.2
                                     0.68
                                     0.16
                                     0.80
                                     0.13
Kidney
                                       
                                     2.26
                                     0.54
                                       
                                     0.43
Liver
                                       
                                     1.97
                                     0.47
                                       
                                     0.38
 Muscle
                                       
                                     0.37
                                     0.088
                                       
                                     0.070
[1]  Obtained by dividing the  maximum residues at the feeding level by the feeding level.
2  Obtained by multiplying the transfer coefficient by the calculated dietary burden.

Table 15.    Transfer Coefficients and Acute Anticipated Residues of Bromoxynil  in Poultry Commodities
Matrix
                                 Feeding Level
                                     (ppm)
                   Maximum Residues at Feeding Level  (ppm)
                                   Transfer
                                Coefficient [1]
                        Calculated Dietary Burden (ppm)
                   Calculated Anticipated Residues (ppm)[3]
Eggs
                                     0.70
                                  <0.05[2]
                                     0.071
                                     0.053
                                    0.0038
Skin/Fat
                                     0.70
                                     0.08
                                     0.11
                                       
                                    0.0061
Liver
                                     0.07
                                     0.063
                                     0.90
                                       
                                     0.048
 Muscle
                                     0.70
                                     0.05
                                     0.071
                                       
                                    0.0038
[1]  Obtained by dividing the  maximum residues at the feeding level by the feeding level.
[2]  Residues in eggs were <0.05 ppm at the highest feeding level (1.0 ppm).
3  Obtained by multiplying the transfer coefficient by the calculated dietary burden.

Table 16.    Transfer Coefficients and Acute Anticipated Residues of Bromoxynil  in Swine Commodities
Matrix
                                 Feeding Level
                                     (ppm)
                   Maximum Residues at Feeding Level  (ppm)
                                   Transfer
                                Coefficient [1]
                        Calculated Dietary Burden (ppm)
                   Calculated Anticipated Residues (ppm)[2]
Fat
                                      4.2
                                     0.68
                                     0.16
                                     0.038
                                    0.0062
Kidney
                                       
                                     2.26
                                     0.54
                                       
                                     0.020
Liver
                                       
                                     1.97
                                     0.47
                                       
                                     0.018
 Muscle
                                       
                                     0.37
                                     0.088
                                       
                                    0.0033
[1]  Obtained by dividing the  maximum residues at the feeding level by the feeding level.
2  Obtained by multiplying the transfer coefficient by the calculated dietary burden.