Bromoxynil Dietary Exposure and Risk Assessment DP Number: 378615

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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 an d Risk Assessments for the New Uses on Grass and Grain Sorghum PC Code s : 0 35301, 035302 DP Barcode: D 3 78615 Decision No.: 4 2 5581 Registration No. : 264 - 1 023 Petition No.: 9F7678 Regulatory Action: Section 3 Registration Risk Assessment Type: Single Chemical Case No.: 2070 T XR 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; 7509 P ) 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 Bethan y Benbow , RM Team 23 Registration Division (RD; 7505P)Bromoxynil Dietary Exposure and Risk Assessment DP Number: 378615

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### Executive Summary Acute, chronic , and cancer aggregate dietary (food and drinking water) exposure and risk assessments were conducted for bromox ynil 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 Survey s of Food Intakes by Individuals (CSFII) from 1994 - 1996 and 1998. The anal ys es were performed t o support Section 3 requests for new uses on grass and grain sorghum . The most recent a cute, chronic , and cancer aggregate dietary

assessments were conducted for bromox yn il to support the Reregistration Eligibility

Decision (RED) in December, 1998 . Acute Dietary

Exposure Results and Characterization A refined dietary

acute analy sis was conducted for bromoxy nil. Average field trial values for grains and anticipated residues in livestock were used in the assessment. Tolerance level residue s 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 s urface water results from the Ti er 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 ( aPA D) , while the most highly

exposed populat ion subgroup, all infants (< 1 year old) , occupied 7.4 % of the aPA D . Anal ys es with and without demonstrate that water adds only marginally

to the acute d ietary

exposure of bromox yn il . Chronic Dietary

Exposure Results and Characterization A refined chronic dietary assessment was conducted for bromox ynil. Average field trial residues were used for all commodities except for spearmint and peppermint where tolerance values were used. L ivestock 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 b y BEAD were used for all crop commodities. Potential residues in drinking water were included in the anal ys es based on surfac e 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 (c PA D), while the most highly exposed population subgroup, Chi ldren 1 - 2 years o ld, occupied 0.3 % of the c PA D. Analy ses with and without water demonstrate that water adds onl y marginally to the chronic dietary

exposure of bromoxy

nil . Cancer Dietary

Exposure Results and Characterization A determination of cancer risk was also performed with DEEM - FCIDTM as part of the present a ssessment, since this chemical was classified as “Possible Human Carcinogen ” based on based on male mouse hepatocellular tumors found in the long term cancerBromoxynil Dietary Exposure and Risk Assessment DP Number: 378615

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### studies . The cancer analy ses 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 safet y 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 In formation 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 SO P 99.6 (20 - AUG - 1999). The most recent acute, chronic, and cancer aggregate dietary assessments were conducted for bromox ynil to support the Reregistration Eligibility Decision (RED) in December, 1998. This document serves as an update to the last dietary assessment for bromox yn il using current approaches and input data . II. Residue Information Bromox ynil (3,5 - dibromo - 4 - hydrox ybenzonitrile) 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 (bromoxy nil) which inhibits photosy nthetic electron transport and oxidative phosphorylation in mitochondria. To lerances are currentl y establ ish ed under 40 CFR §180 . 324(a)(1 ) for bromoxy nil 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 fractio ns, grass, oat, onion, peppermint , rye, sorghum, spearmint, and wheat commodities at levels ranging from 0.05 ppm to 9.0 ppm. Tolerances are currentl y established under 40 CFR §180 . 324(a) (2) for bromox ynil residues and its metabolite, 3,5 - dibromo - 4 - hydroxy benzoix 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 by products 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 bromoxy nil 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 adequatel y understood. The residue o f concern in plants other than cotton is bromoxy nil. The residues of concern in transgenic BXN cotton and cotton commodities are bromox ynil and its metabolite DBHA. The DBHA metabolite is only found in transgenic cotton, and not in otherBromoxynil 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 adequatel y understood for bromox yn il. Pending the receipt of an additional livestock metabolism study for DBHA, bromoxy

nil is the residue of concern in livestock c ommodities for the tolerance expression while bromoxy nil and DBHA are the residues of concern in livestock commodities for the risk assessment (D 3 78614 , Nancy Dodd , 17 -NOV - 2010). Residue information for the proposed amended tolerances included in the pres ent analy ses was taken from the bromox ynil residue chemistry memo ( D 3 78614 , Nancy

Dodd, 17 -NOV - 2010 ). A refined dietary

ac ute analy sis was conducted for bromoxy nil. 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 (D 3 78614 , Nancy Dodd, 17 -NOV - 2010). Maximum percent crop treated estimates provided by BEAD were used for all crop commodities (D 382833 , Arthur Grube, 22 - OCT - 2010) and (D 378991 , Jihad Alsadek, 08 - July - 2010 ). Default processing factors were used. Refined dietary

chronic and cancer analy ses were conducted for bromoxy nil. 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 feed ing studies (D 3 78614 , Nancy Dodd, 17 -NOV - 2010). Average percent crop treated estimates provided by B EAD were used for all crop (D 382833 , Arthur Grube, 22 - OCT - 2010) and (D 378991 , Jihad Alsadek, 08 - July - 2010) . Default processing factors were used. Tabl e 1 summarizes the bromoxy nil residue levels , percent crop treated values , and processing factors for a ll crops and livestock commodities used in the acute, chronic and can c er dietary assessments.Bromoxynil Dietary Exposure and Risk Assessment DP Number: 378615

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Page 5 of 30 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 M ax.

Percent Crop Treated [Acute] 1 Processing

Factors

Alfalfa2 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 Sy rup: 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 Garli c 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; F at 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; M eat 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 Milk9 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 (D 3 82833 , Arthur Grube , 22 - OCT - 2010 

### ) and (D 3 78991 , Jihad Alsadek , 08 - July - 2010 

### ) 2 DP Number 195998, C. Swartz, 3/6/96, MRIDs 00150382, 42950101 (alfalfa); MRID 44386601. T he averag e residue for alfalfa 0.13 ppm w as 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

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Page 6 of 30 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 s hould 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) ( D 3 74620 , Tiffan y M ason , 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

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

### μ g/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 app lication s of 0. 305 lbs. ai/A at 11 - day

interval 

### Surface Water . The Tier I screening models FIRST Version 1.1.1 (FQPA I ndex R eservoir S creening T ool) with Percent Crop Area adjustment factor was used to determine drinking water concentrations of b romoxy nil derived from surface water sources. For the Peak EEC, the highest FIRST estimated drinking water concentration (EDWC) fo r bromox ynil was 11.5 μg/L based on appli cation to sorghum . For annual average, the h ighest 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 concentration s of b romox yn il derived from shallow ground water . The c otton result e d in the highest groundwater EDWC of 0.00326 μg/L . However, b ecause the surface water estimates were highe r than the groundwater estimates, the present analy ses made use o f the formerBromoxynil 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 Bromox ynil acute and chronic dietary exposure assessments were conducted using th e 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 survey s . The 1994 - 96, 98 data are based on the reported consumption of more than 20,000 individuals over two non - consecutive survey day s. 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 publicl y 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 popu lation subgroups. Based on anal ys is 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+ ye ars old. For chronic dietary

exposure assessment s , 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 dail y 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 perc entage of the aPAD on both a user (i.e., onl y 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 cap ita exposure and risk are reported for all tiers of anal ys is. However, for tiers 1 and 2, any significant differences in user vs. per capita exposure and risk are specificall y identified and noted in the risk assessment. V. Toxicological Information All current information specific to th e t oxicity characteristics of bromox ynil will be presented in the upcoming risk assessment supporting the proposed uses (D 374609 , Cassi Walls ) . For the acute and c hronic exposure scenario s , the standard 100 fold UF was applied to account for inter - species extrapolation and intra - species variation . The pointsBromoxynil 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, i t should be noted that based on a recent BMD anal ys is , 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 th e toxicological profile, a summary of the doses and endpoints selected for the re le vant dietary exposure scenarios is provided in Table 3 . Table 3 . Summary of Toxicological Doses and Endpoints for Brom oxynil 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 Ac ute Dietary (General Population, including Infants and Children) NOAEL =

8 mg/kg/day UF A = 10x

UF H = 10x FQPA SF = 1x Ac ute 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 Ac ute Dietary (Females 13 - 49 years of age) NOAEL =

4 mg/kg/day UF A= 10 x

UF H =10 x FQPA SF=1x Ac ute 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 UF A = 10x

UF H = 10x FQPA SF= 1x Chronic RfD =

0.0 15 mg/kg/day cPAD = 0.0 15 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 Revie w 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 mo del (Q 1 *) be applied to the experimental animal tumor data for quantification of human risk. Q 1 * = 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 humanBromoxynil Dietary Exposure and Risk Assessment DP Number: 378615

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Page 9 of 30 exposures. NOAEL = no ob served adverse effect level. LOAEL = lowest observed adverse effect level. UF = uncertainty factor. UF A = extrapolation from animal to human (intraspecies). UF H = 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 anal ys es estimat e the dietary exposure of the U S 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+ ye ars. Results of Acute Dietary (Food and Drinking Water) Exposure Anal ys is Refined a cute dietary

risk anal ys es were conducted with the DEEM - FCIDTM model to form a conservative evaluation of exposure for bromo xy nil . At the 95 th 

### , 99 th 

### , and 99.9 th 

### percentile s of exposure, a ll acute anal ys e s 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 di etary 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 ye ar old) , acute aggregate dietary risk occup ied 7.4 % of the aPAD with an exposure of 0.0 05 9 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 ad ded by water consumption is relativel y 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 Table s 4 and 5 . Table 4 . Results of Acute Dietary (Food Only ) Exposure Analysis Using DEEM FCID Population Subgroup aPAD (m g/kg/day) 95 th Percentile 99 th Percentile 99.9 th Percentile

Exposure (m g/kg/day) %

aPAD Exposure

(m g/kg/day) %

aPAD Exposure

(m g/kg/day) %

aPAD General U.S. Population

0.08 0.000 429 0. 54 0.00 0788 1. 0 0.001 504 1.9 All Infants (< 1 year old) 0.000 472 0. 59 0.00 1 011 1. 3 0.002 311 2.9 Children 1 - 2 years old 0.00 0950 1. 2 0.001 439 1.8 0.00 2472 3.1 Children 3 - 5 years old 0.00 0815 1. 0 0.001 330 1.7 0.00 2682 3.4 Children 6 - 12 years old 0.000 563 0.70 0.00 0901 1. 1 0.00 1924 2. 4 Youth 13 - 19 years old 0.000 382 0. 48 0.000 654 0.82 0.00 1503 1.9 Adults 20 - 49 years old 0.000 340 0. 43 0.000 561 0. 70 0.001 165 1. 5 Adults 50+ years old 0.000 266 0. 33 0.000 458 0. 57 0.001 134 1. 4 Females 13 - 49 years old 0.04 0.000 296 0.74 0.000 493 1. 2 0.00 0912 2.3Bromoxynil Dietary Exposure and Risk Assessment DP Number: 378615

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Page 10 of 30 Table 5 . Results of Acute Dietary (Food and Drinking Water ) Exposure Analysis Using DEEM FCID Population Subgroup aPAD (m g/kg/day) 95 th Percentile 99 th Percentile 99.9 th Percentile

Exposure (m g/kg/day) %

aPAD Exposure

(m g/kg/day) %

aPAD Exposure

(m g/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 0.0033 38 4.2 0.0058 92 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 0.0021 24 2.7 0.0035 27 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 0.8 2 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 Anal ys is C hronic dietary

risk analy s e s were conducted with the DEEM - FCIDTM model to form a refined evaluation of exposure to bromox ynil . All chronic analy s e s yield ed risk estimates well below the 100% of the c PA D threshold level of concern for each population subgroup. For the general US Population , chronic aggregate dietary risk w as calculated at 0.1 % of the cPAD with an exposure level of 0.00 0014 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 c PA D with an exposure of 0.0 00040 mg/kg/day . Comparison of the food onl y results to the food + water results demonstrates that the additional risk added b y water consumption is small. An overview summarizing the results of the chronic dietary

assessment with the population subgroup h aving the highes t 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 hepatocel lular tumors found in the long term cancer studies. The cancer analy ses yielded an aggregate (food and water) risk estimate of 1.5 x 10 - 6 

### for the general US Population. Comparison of the food onl y results to the food + water results demonstrates that the additional risk added b y 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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Page 11 of 30 Table 6 . Result s of Chronic Dietary Exposure and Risk Estimates for Brom oxynil . 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 y

rs 0.000026 0.2 0.000032 0.2 Children 6 - 12 y

rs 0.000017 0.1 0.000021 0.1 Youth 13 - 19 y

rs 0.000010 0.1 0.000013 0.1 Adults 20 - 49 y

rs 0.000008 0.1 0.000011 0.1 Adults 50+ yrs 0.000006 <0.1 0.000010 0.1 Females 13 - 49 y

rs 0.000007 <0.1 0.000011 0.1 Table 7 . Result s of Cancer Exposure and Risk Estimates for Brom oxynil. 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 y

rs Children 3 - 5 y

rs Children 6 - 12 y

rs Youth 13 - 19 y

rs Adults 20 - 49 y

rs Adults 50+ yrs Females 13 - 49 y

rs 

### VII. Characterization of Inputs/Outputs The acute dietary

assessment conducted with DEEM - FCIDTM for bromoxy nil is a relativel y refined analy si s. The refinements include: average field trial values for all grains ; estimated l ivestock anticipated residues using results from the crop field trials and animal feeding studies; and m aximum percent crop treated estimates for all crop commodities . However, this assessment also utilized some conservat ive values including: t olerance levels for cotton, garlic, onion, peppermint and spearmint; d efa ult processing factors; and conse rvative EDW Cs derived through EFED Tier 1 modeling . EFED’s Tier 1 modeling is unlikely to underestimate the concentration of bromoxy nil in drinking water . The present DEEM - FCIDTM analy sis assumes that all drinking water will contain bromox yn il at the highest acute E DW C levels modeled by EFED for groundwater or surface water . It can be concluded that the DEEM - FCIDTM anal ys i s do es not underestimate risk from acute exposure to bromoxy nil for the general US population and all its subgroups.Bromoxynil Dietary Exposure and Risk Assessment DP Number: 378615

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### The chronic dietary

assessment conducted with DEEM - FCIDTM for bromoxy nil is also a refined anal ys is. The refinements used in this assessment inc ludes: 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 th e concentration of bromoxy nil in drinking water . The present DEEM FCIDTM analy sis assumes that all drinking water will contain bromox yn il at the highest chronic EDWC le vels modeled b y EFED for groundwater or surface water. It can be concluded that the DEEM - FCIDTM anal ys is does not underestimate risk from chronic or cancer exposure to bromoxy nil for the general US population and all its subgroups. VIII. Conclusions The acute dietary risk assessment conducted with DEEM - FCIDTM indicate s that exposure s to bromox yn il are below HED’s level of concern. The acute aggregate (food and water) dietary

risk to bromox yn il 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 highl y exposed population subgroup , All Infants (<1 ye ar 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 use s of bromoxy nil could result in unacceptable risk through the potential acute dietary exposure from food and water sources . The chro nic dietary

risk assessment conducted with DEEM - FCIDTM indicates that exposures to bromox yn il are below HED’s level of concern. The chronic aggregate (food and water) dietary

risk to bromoxy

nil 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 resultin g chronic dietary risk is 0.3 % of the cPAD. Therefore , HED is not concerned that the proposed new uses of bromox ynil 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 bromox yn il 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 onl y) 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

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### 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 L ivestock.Bromoxynil Dietary Exposure and Risk Assessment DP Number: 378615

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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 0.70 0 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 B arley, 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 15 001210 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 1.50 0 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/rolle d 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 Whea t, 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 21000 440 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 1.000Bromoxynil Dietary Exposure and Risk Assessment DP Number: 378615

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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 26003 400 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, wat er - 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 byp roducts - 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 Turk ey, 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 50003 861 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 b yproducts 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 0.10000 0 1.000 0.250 95002760 O Peppermint, oil 0.100000 1.000 0.250Bromoxynil Dietary Exposure and Risk Assessment DP Number: 378615

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Page 16 of 30 95003520 O Spearmint 0.100000 1.000 0.250 95003530 O Spearmint, oil 0.100000 1.000 0.250Bromoxynil Dietary Exposure and Risk Assessment DP Number: 378615

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Page 17 of 30 ATTACHM

ENT 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. Analysi s 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 0.0 05892 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: 0.0 01008 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 A dults 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 4.39Bromoxynil Dietary Exposure and Risk Assessment DP Number: 378615

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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 cal culations (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 y rs: 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 2.28Bromoxynil Dietary Exposure and Risk Assessment DP Number: 378615

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Page 19 of 30 ATTACHMENT 4 Filename: C: \ Documents and Settings \ cwalls \ My Documents \ Cassi \ H ED \ 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 Garl ic, 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 15000 260 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, star ch - 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 15003 450 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 byprod ucts - 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 1.000Bromoxynil Dietary Exposure and Risk Assessment DP Number: 378615

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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 25002 910 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, fa t 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 soli ds 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 Chic ken, 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 50003 820 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 - babyfo od 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 Cott onseed, 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 0.250Bromoxynil Dietary Exposure and Risk Assessment DP Number: 378615

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Page 21 of 30 95003520 O Spearmint 0.100000 1.000 0.250 95003530 O Spearmint, oil 0.100000 1.000 0.250Bromoxynil Dietary Exposure and Risk Assessment DP Number: 378615

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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 0.0 00012 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%

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PC Code: 035301, 035302

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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 chron ic 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 s eason) 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 0.00001 1 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% M ales 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 - 2011/1 3:58:19/8 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 s eason) 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 ye ar) 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 3.48 E - 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 y rs 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 0.00 0008 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 2 0+ 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 Catt le 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 Brom oxynil Residues in Cattle Tissues Feeding Level (ppm) Average Brom oxynil 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 Brom oxynil Residues in Poultry Tissues Feeding Level (ppm) Average Brom oxynil 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 p pm) at the highest feeding level ( 0.70 ppm). Calculation of Anticipated R esidues for Livestock Commodities - Chronic and Cancer Assessments Table 3 . Livestock Feed Items for Chronic Assessment Comm odity 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

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Page 27 of 30 Table 4 . Brom oxynil Dietary Contributions for Chronic Assessment u sing Av erage Residues fromField 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 R esidues for Livestock Commodities – Acute Assessment Table 5 . Livestock Feed Items for Acute Analysis for Beef Cattle, Poultry, and Swine Comm odity Recommended/

Established Tolerance (ppm) Anticipated Residue (ppm) 1 Alfalfa, meal 2

-- 4 0.25 Barley, grain 3 0.05 0.01 Barley, hay2 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, Septembe r 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.Bromoxynil Dietary Exposure and Risk Assessment DP Number: 378615

PC Code: 035301, 035302

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Page 28 of 30 Table 6 . Brom oxynil 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 Comm odity 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.Bromoxynil Dietary Exposure and Risk Assessment DP Number: 378615

PC Code: 035301, 035302

______________________________________________________________________________________

Page 29 of 30 Table 8 . Brom oxynil Dietary C ontributions 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 Brom oxynil in Dairy Cattle Comm odities Matrix Feeding Level

(ppm) Maximum Residu es

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 Brom oxynil in Beef Cattle Comm odities Matrix Feeding Level

(ppm) Maximum Residu es

at Feeding Level (ppm) Tr ansfer

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 Brom oxynil in Poultry Commodities Matrix Feeding Level

(ppm) Maximum Residu es

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.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 Brom oxynil in Swine Comm odities Matrix Feeding Level

(ppm) Maximum Residu es

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 Brom oxynil in Dairy Cattle (Milk) Matrix Feeding Level

(ppm) Maximum Residu es

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 Brom oxynil in Beef Cattle Commodities Matrix Feeding Level

(ppm) Maximum Residu es

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 Brom oxynil in Poultry Commodities Matrix Feeding Level

(ppm) Maximum Residu es

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 1 6 . Transfer Coefficients and Acute Anticipated Residues of Brom oxynil in Swine Comm odities Matrix Feeding Level

(ppm) Maximum Residu es

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.