Bromoxynil Dietary Exposure and Risk Assessment DP Number: 378615

PC Code: 035301, 035302

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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) 
Bromoxynil Dietary Exposure and Risk Assessment DP Number: 378615

PC Code: 035301, 035302

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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-FCIDTM, 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 99.9th 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-FCIDTM 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 
Bromoxynil Dietary Exposure and Risk Assessment DP Number: 378615

PC Code: 035301, 035302

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studies. The cancer analyses yielded an aggregate (food and water) risk estimate of 1.5 x 

10-6for 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 
Bromoxynil Dietary Exposure and Risk Assessment DP Number: 378615

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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. 
Bromoxynil Dietary Exposure and Risk Assessment DP Number: 378615

PC Code: 035301, 035302

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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

Alfalfa20.13 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 40.01 0.01 35 35

Sorghum 50.028 0.028 <2.5 <2.5

Cotton 61.5 0.3 <2.5 5

Garlic 70.1 0.01 50 70

Onion70.1 0.01 55 70 Dried: 9.0

Mint (peppermint and 

spearmint) 8

0.1 0.1 25 25

Cattle, goat, horse, sheep; 

Fat9

0.13 0.0024

Cattle, goat, horse, sheep; 

meat byproducts9

Kidney: 0.43

Liver: 0.38

Kidney: 0.0081

Liver: 0.0070

Cattle, goat, horse, sheep;

Meat9

0.070 0.0013 Dried:1.92

Egg90.0038 0.000078

Hog, fat90.0062 0.00015

Hog, meat byproducts9 Kidney: 0.020

Liver: 0.018

Kidney: 0.00051

Liver: 0.00044

Hog, meat90.0033 0.000083

Milk90.0032 0.00054

Poultry, fat90.0061 0.00013

Poultry, meat byproducts9 Liver: 0.048 Liver: 0.00099

Poultry, meat90.0038 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).
Bromoxynil Dietary Exposure and Risk Assessment DP Number: 378615

PC Code: 035301, 035302

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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-DEC2010). Water residues presented in Table 2 were directly incorporated in the DEEMFCID 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 
Bromoxynil Dietary Exposure and Risk Assessment DP Number: 378615

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values, expressed to two significant figures and converted into the proper units for the 

DEEM program (ppm).

IV. DEEM-FCIDTM Program and Consumption Information

Bromoxynil acute and chronic dietary exposure assessments were conducted using the 

DEEM-FCIDTM 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 percapita (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 
Bromoxynil Dietary Exposure and Risk Assessment DP Number: 378615

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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 
Bromoxynil Dietary Exposure and Risk Assessment DP Number: 378615

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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-FCIDTM 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-FCIDTM model to 

form a conservative evaluation of exposure for bromoxynil. At the 95th, 99th, and 99.9th

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 99.9th 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 

99.9th 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)

95th Percentile 99th Percentile 99.9th 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
Bromoxynil Dietary Exposure and Risk Assessment DP Number: 378615

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Table 5. Results of Acute Dietary (Food and Drinking Water) Exposure Analysis Using DEEM FCID 

Population Subgroup aPAD 

(mg/kg/day)

95th Percentile 99th Percentile 99.9th 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-FCIDTM 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-FCIDTM 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 

10-6for 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.
Bromoxynil Dietary Exposure and Risk Assessment DP Number: 378615

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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 10-60.000014 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-FCIDTM 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-FCIDTM 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-FCIDTM analysis does not 

underestimate risk from acute exposure to bromoxynil for the general US population and 

all its subgroups.
Bromoxynil Dietary Exposure and Risk Assessment DP Number: 378615

PC Code: 035301, 035302

______________________________________________________________________________________

Page 12 of 30

The chronic dietary assessment conducted with DEEM-FCIDTM 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 DEEMFCIDTM 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-FCIDTM 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-FCIDTM 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 99.9th 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 99.9th 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-FCIDTM 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-FCIDTM indicates that food 

and water exposures to bromoxynil results in a cancer risk estimate of 1.5 x 10-6for 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.
Bromoxynil Dietary Exposure and Risk Assessment DP Number: 378615

PC Code: 035301, 035302

______________________________________________________________________________________

Page 13 of 30

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.
Bromoxynil Dietary Exposure and Risk Assessment DP Number: 378615

PC Code: 035301, 035302

______________________________________________________________________________________

Page 14 of 30

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 
Bromoxynil Dietary Exposure and Risk Assessment DP Number: 378615

PC Code: 035301, 035302

______________________________________________________________________________________

Page 15 of 30

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 
Bromoxynil Dietary Exposure and Risk Assessment DP Number: 378615

PC Code: 035301, 035302

______________________________________________________________________________________

Page 16 of 30

95003520 O Spearmint 0.100000 1.000 0.250 

95003530 O Spearmint, oil 0.100000 1.000 0.250 

 
Bromoxynil Dietary Exposure and Risk Assessment DP Number: 378615

PC Code: 035301, 035302

______________________________________________________________________________________

Page 17 of 30

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
Bromoxynil Dietary Exposure and Risk Assessment DP Number: 378615

PC Code: 035301, 035302

______________________________________________________________________________________

Page 18 of 30

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 
Bromoxynil Dietary Exposure and Risk Assessment DP Number: 378615

PC Code: 035301, 035302

______________________________________________________________________________________

Page 19 of 30

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 
Bromoxynil Dietary Exposure and Risk Assessment DP Number: 378615

PC Code: 035301, 035302

______________________________________________________________________________________

Page 20 of 30

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 
Bromoxynil Dietary Exposure and Risk Assessment DP Number: 378615

PC Code: 035301, 035302

______________________________________________________________________________________

Page 21 of 30

95003520 O Spearmint 0.100000 1.000 0.250 

95003530 O Spearmint, oil 0.100000 1.000 0.250 
Bromoxynil Dietary Exposure and Risk Assessment DP Number: 378615

PC Code: 035301, 035302

______________________________________________________________________________________

Page 22 of 30

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%

-------------------------------------------------------------------------------
Bromoxynil Dietary Exposure and Risk Assessment DP Number: 378615

PC Code: 035301, 035302

______________________________________________________________________________________

Page 23 of 30

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%

-------------------------------------------------------------------------------
Bromoxynil Dietary Exposure and Risk Assessment DP Number: 378615

PC Code: 035301, 035302

______________________________________________________________________________________

Page 24 of 30

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

-------------------------------------------------------------------------------
Bromoxynil Dietary Exposure and Risk Assessment DP Number: 378615

PC Code: 035301, 035302

______________________________________________________________________________________

Page 25 of 30

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%

-------------------------------------------------------------------------------
Bromoxynil Dietary Exposure and Risk Assessment DP Number: 378615

PC Code: 035301, 035302

______________________________________________________________________________________

Page 26 of 30

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

1Residues 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.
Bromoxynil Dietary Exposure and Risk Assessment DP Number: 378615

PC Code: 035301, 035302

______________________________________________________________________________________

Page 27 of 30

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, ppm1 % Dry 

Matter Beef Dairy Poultry Swine Beef Diary Poultry2

Swine2

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

1The 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, meal2--

4

0.25

Barley, grain30.05 0.01

Barley, hay29.0 3.7

Cotton, gin byproducts27.0 6.4

Cotton, meal3--

5

0.10

Cotton, undelinted seed31.5 0.30

Sorghum, grain, grain30.2 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. 

5The cotton, undelinted seed tolerance is 1.5 ppm and is adequate to cover residues in cotton meal.
Bromoxynil Dietary Exposure and Risk Assessment DP Number: 378615

PC Code: 035301, 035302

______________________________________________________________________________________

Page 28 of 30

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, ppm1 % 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. 

3The cotton, undelinted seed tolerance is 1.5 ppm and is adequate to cover residues in cotton meal.
Bromoxynil Dietary Exposure and Risk Assessment DP Number: 378615

PC Code: 035301, 035302

______________________________________________________________________________________

Page 29 of 30

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, ppm1 % 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 <0.0520.071 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.
Bromoxynil Dietary Exposure and Risk Assessment DP Number: 378615

PC Code: 035301, 035302

______________________________________________________________________________________

Page 30 of 30

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 <0.0520.071 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.