UNITED STATES ENVIRONMENT AL PROTECTION AGENCY 

MEMORANDUM 

Date: February 25, 2016 

WASHINGTON, D.C. 20460 

OFFICE OF CHEMICAL SAFETY 

AND POLLUTION PREVENTION 

SUBJECT: Fluazinam Acute and Chronic Aggregate Dietary (Food and Drinking Water) 

Exposure and Risk Assessments for the Section 3 Registration Action for New 

Uses on Tuberous and Corm, Subgroup IC, Mayhaw, Squash/Cucumber 

Subgroup 9B; Amended Uses on Cabbage; and Removal of Cabbage from 

Vegetable, Brassica leafy, group 5. 

PC Code: 129098 

Decision Nos.: 499960, 502449 

Petition: 5E8349 

Risk Assessment Type: Dietary 

TXRNo.: NA 

MRIDNo.: NA 

DP Barcode: D429506 

Registration No.: 71512-1 

Regulatory Action: Section 3 Registration 

Case No.: 7013 

CAS No.: 79622-59-6 

40 CFR: §180.574 

FROM: Elizabeth Holman, DrPH, Physical Scientist 

Risk Assessment Branch II 

Health Effects Division (7509P) 

THROUGH: Kristin Rury, MPH, Biologist y__ Q ~ Julie Van Alstine, MPH, Environme~t;l ~h Scientist 

Dietary Exposure Science Advisory Council 

TO: Andrew Ertman/Barbara Madden, Minor Use Team 

Risk Integration Minor Use, and Emergency Response Branch 

Registration Division (7505P) 

Executive Summary 

Acute and chronic aggregate dietary [food and drinking water] exposure and risk assessments 

were conducted using the Dietary Exposure Evaluation Model software with the Food 

Commodity Intake Database (DEEM-FCID) Version 3.16. This software uses 2003-2008 food 

consumption data from the U.S. Department of Agriculture's (USDA's) National Health and 

Page I of 17 
Fluazinam Dietary Exposure and Risk Assessment DP Number: D429506 

Page 2 of 17 

Nutrition Examination Survey, What We Eat in America, (NHANES/WWEIA). The analyses 

were conducted as part of a human health risk assessment for the proposed new uses of 

fluazinam on tuberous and corm vegetables, Subgroup 1C; Mayhaw; Squash/Cucumber 

Subgroup 9B; an amended use on cabbage; and removal of cabbage from vegetable, Brassica

leafy, group 5. The estimated drinking water concentrations (EDWCs) are based on a currently 

registered use on turf. This memorandum was reviewed by two peer reviewers of the DESAC, 

per DESAC SOP 2012.1. 

The acute analysis is based on tolerance-level residues for all commodities and uses high-end 

residue estimates for the metabolite AMGT. In addition, the acute assessment assumes 100% 

crop treated and incorporates modeled EDWCs that account for both parent fluazinam and its 

transformation products. Therefore, the resulting exposure and risk estimates are considered to 

be very conservative. The acute risk estimates at the 95th percentile of exposure are below 

HED’s level of concern for all population subgroups, including those comprised of infants and 

children. Generally, HED is concerned when risk estimates exceed 100% of the populationadjusted dose (PAD). The acute risk estimate for the General U.S. Population is 5.7% of the 

acute PAD (aPAD). The aPAD is lower for females 13 to 49 years old. Although Children 1-2 

years old have the highest exposure estimate (0.112064 mg/kg/day; 22% aPAD), the population 

subgroup with the highest risk estimate is females 13 to 49 years old, which utilizes 32% of the 

aPAD (0.022220 mg/kg/day). 

The chronic analysis is based on tolerance-level residues for all commodities except apples. For 

apples, the average field trial value was used. As with the acute assessment, it assumes high-end 

estimates for AMGT, 100% crop treated, and incorporates modeled EDWCs that account for 

both parent and transformation products. The resulting exposure and risk estimates are 

considered to be conservative. Chronic risk estimates are below HED’s level of concern for all 

population subgroups. The risk estimate for the General U.S. Population is 41% of the chronic 

PAD (cPAD). The most highly exposed population subgroup is All Infants, which uses 92% of 

the cPAD. 

Fluazinam is classified as having “suggestive evidence of carcinogenicity, but not sufficient to 

assess human carcinogenic potential.” The CARC determined that quantification of risk using a 

non-linear approach (i.e., RfD) will adequately account for all chronic toxicity, including 

carcinogenicity, that could result from exposure to fluazinam. As a result, the chronic dietary 

exposure assessment is protective for potential cancer risk.

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 that HED has concluded will result in no unreasonable adverse health effects). 

This dose is referred to as the population-adjusted dose (PAD). The PAD is equivalent to the 

point of departure (POD, e.g. no observed adverse effect level (NOAEL), lowest observed 

adverse effect level (LOAEL)) divided by the required uncertainty or safety factors. 
Fluazinam Dietary Exposure and Risk Assessment DP Number: D429506 

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For acute and non-cancer chronic exposures, HED is concerned when estimated dietary risk 

exceeds 100% of the PAD. References that 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.regulations.gov/#!documentDetail;D=EPA-HQ-OPP-2007-0780-0001; or see SOP 

99.6 (20-AUG-1999). 

The most recent dietary risk assessment for fluazinam was conducted by D. Dotson (D397722, 

9/7/2012). 

II. Residue Information

Fluazinam is currently registered in the U.S. for use on a number of crops, including carrots, 

melon (subgroup 9A), potatoes, ginseng, the Bulb onion subgroup (3-07A), head lettuce, leaf 

lettuce, Crop Group 5 (Brassica leafy vegetables), turnip greens, peanuts, apples, the Bushberry 

subgroup (13-07B), and Crop subgroups 6-A (except pea), 6-B (except pea), and 6-C (except 

pea). In addition, there is a tolerance without U.S. registration on wine grapes. Tolerances for 

these commodities range from 0.01 ppm to 7.0 ppm. Tolerances have also been established for 

residues in the fat and meat byproducts of cattle, goats, horses, and sheep. The tolerances for 

fluazinam are listed in 40 CFR 180.574. 

The metabolite AMGT is a residue of concern for some commodities, but not for others. In the 

crop field trials that were performed, AMGT was measured in some commodities but not in 

others. As a result, the residue levels that were used in the dietary exposure assessments were 

determined in different ways. The residue of concern for risk assessment in peanuts, bulb 

vegetables, and root and tuber vegetables is parent fluazinam. For all other plant commodities, 

the residues of concern in plants for risk assessment are fluazinam and its metabolite AMGT. 

Table 1 summarizes the residue input values used in the acute and chronic assessments. 

As the residue of concern in peanuts, bulb vegetables, and root and tuber vegetables is parent 

only, tolerance-level residues were used for these commodities. 

For the commodities in the current tolerance petition (mayhaw, summer squash, cucumber, and 

cabbage), residues of parent fluazinam as well as residues of AMGT were measured in the field 

trial studies. Similarly, for soybeans, cantaloupe, and peppers, residues of parent fluazinam as 

well as residues of AMGT were measured in the field trials (D. Dotson, D397722, 9/7/2012). 

For these commodities, the limit of quantification (LOQ) for AMGT was 0.01 ppm. All samples 

had residue levels below the LOQ. As a result, the total residue used in the dietary exposure 

assessment was the tolerance plus 0.01 ppm. 

Both fluazinam and AMGT were also measured in the grape and apple field trials. The 3.0 ppm 

tolerance for grapes covers all residues of concern. The fluazinam apple tolerance is 2.0 ppm, 

and the highest combined (fluazinam + AMGT) residue is below the tolerance (1.69 ppm). The 

apple tolerance was used in the acute assessment and the average combined (fluazinam + 

AMGT) residue value of 0.215 ppm was used in the chronic assessment. As part of the current 

tolerance petition, the tolerance on apple is being translated to mayhaw (for further details, see S. 
Fluazinam Dietary Exposure and Risk Assessment DP Number: D429506 

Page 4 of 17 

Biswas, D426161, 09/18/2015). As mayhaw is not included in DEEM, this tolerance is not 

reflected in the residue input files or listed in Table 1. 

For bushberries, the mean ratio of the metabolite:parent residues (0.11:1) from field trials was 

used to estimate the total residues of concern, and the bushberry tolerance of 7.0 ppm was 

multiplied by a factor of 1.11. 

For the other commodities, an upper-bound ratio of 0.35:1 (AMGT:fluazinam) was used to 

estimate the AMGT residue. This factor is the maximum AMGT:fluazinam ratio in grapes 

determined in the grape metabolism study. The values obtained using this ratio were used in 

both the acute and chronic assessments. For more information concerning the residue levels 

used in the dietary exposure assessments, see the previous dietary exposure memos that were 

written for fluazinam (D276982, W. Cutchin, 8/22/2001; D340854, M. Doherty, 8/1/2007; and 

D374522, D. Dotson, 3/31/2010). 

In livestock commodities, the residues of concern for risk assessment and tolerance enforcement 

are the same: parent fluazinam, its metabolites AMPA and DAPA, and their sulfamate 

conjugates. The tolerance level of 0.05 ppm is being used for meat byproducts and fat of cattle, 

goats, horses, and sheep (Memo, D360840, D. Dotson, 3/31/2010). This value is very 

conservative because it accounts for all residues of concern in the livestock commodities for 

which tolerances have been established. 

DEEM 7.81 default processing factors were used for all processed commodities for which they 

were available (Table 2). Full listings of the residue inputs used in the analyses are included as 

Attachments 1 and 3. 

Table 1. Summary of Crop Residue Levels Used in the Acute and Chronic 

Dietary Exposure Analyses

Crop/Crop Group Tolerance Level 

(ppm) 

Residue Level used in 

Assessments (ppm) 

Derivation of 

Residue Level 

Carrots 0.70 0.70 Tolerance (parent only) 

Vegetable, Tuberous and 

Corm, Subgroup 1C 

0.02 0.02 HED-Recommended 

Tolerance (parent only) 

Ginseng 4.5 4.5 Tolerance (parent only) 

Bulb Onions (Subgroup 3-

07A) 

0.20 0.20 Tolerance (parent only) 

Head Lettuce 0.02 0.027 0.02 tolerance x 1.35 

Leaf Lettuce 2.0 2.7 2.0 tolerance x 1.35 

Brassica Leafy Vegetables, 

except Cabbage 

0.01 0.0135 0.01 tolerance x 1.35 

Cabbage 3.0 3.01 HED-Recommended 

Tolerance + 0.01 

Turnip Greens 0.01 0.0135 0.01 tolerance x 1.35 

Edible-Podded Legumes, 

Subgroup 6-A, except pea 

0.10 0.135 0.1 tolerance x 1.35 

Succulent Shelled Legumes, 

Subgroup 6-B, except pea 

0.04 0.054 0.04 tolerance x 1.35 

Dried Shelled Legumes, 

Subgroup 6-C, except pea 

0.02 0.027 0.02 tolerance x 1.35 

Soybean 0.01 0.02 Tolerance + 0.01 
Fluazinam Dietary Exposure and Risk Assessment DP Number: D429506 

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Peanuts 0.02 0.02 Tolerance (parent only) 

Peppers/Eggplant (8-10B) 0.09 0.10 Tolerance + 0.01 

Cucurbit Vegetables, Group 

9* 

0.07 0.08 HED-Recommended 

Tolerance + 0.01 

Apples (Acute Assessment) 2.0 2.0 Tolerance includes parent 

and AMGT 

Apples (Chronic 

Assessment) 

2.0 0.215 Avg combined residue 

(fluazinam + AMGT) 

Bushberry Subgroup 13-

07B 

7.0 7.8 Tolerance x 1.11 

Wine Grapes (imported) 3.0 3.0 Tolerance includes parent 

and AMGT 

Fat of cattle, goat, horse, 

and sheep 

0.05 0.05 Tolerance 

Meat byproducts of cattle, 

goat, horse, and sheep 

0.05 0.05 Tolerance 

* Based on the available field trial data for summer squash and cucumber, it is appropriate to establish a cucurbit 

vegetable (Group 9) tolerance at 0.07 ppm (S. Biswas, D426161, 09/18/2015). This is an expansion from the 

existing subgroup 9A (Melon) tolerance at 0.07 ppm. 

Table 2. Fluazinam Processing Factors. 

Commodity DEEM Default Processing Factors 

Apple 

 Juice 1.3x 

 Dried 8.0x 

Potato – dry 6.5x 

Onion – dried 9.0x 

Peanut - butter 1.89x 

Cranberry – juice 1.1x 

Residues in Fish 

Tolerances have not been established for residues in fish commodities. Fluazinam has a low 

water solubility and a relatively high octanol/water partition coefficient. As a result, it will not 

dissolve in water to a significant extent. Residues have the potential to partition into sediment at 

the bottoms of water bodies, however. Catfish are bottom feeders and residues in catfish serve as 

a marker for pesticide residues. The USDA Pesticide Data Program (PDP) monitored pesticide 

residues in catfish in 2008, 2009, and 2010. The catfish samples were not analyzed for 

fluazinam, however. As a result, residues in fish were not included in the dietary exposure 

assessments. 

III. Percent Crop Treated Information

The acute and chronic assessments were both based on the assumption that 100% of all 

commodities with fluazinam tolerances will be treated. 

IV. Drinking Water Data 

The drinking water residues used in the dietary risk assessment were provided by the 

Environmental Fate and Effects Division (EFED; D426144, J. Meléndez, 10/6/2015) and 

incorporated directly into this dietary assessment into the food categories “water, direct, all 
Fluazinam Dietary Exposure and Risk Assessment DP Number: D429506 

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sources” and “water, indirect, all sources.” The residues of concern in drinking water for risk 

assessment are parent fluazinam and its transformation products, including DCPA, CAPA, 

DAPA, HYPA, and AMPA. 

The estimated acute and chronic EDWCs are based on ground application of fluazinam to turf. 

The values are provided in Table 3, below. The groundwater value was generated using the 

Pesticide Root Zone Model for Groundwater (PRZM-GW) Model and the surface water values 

were generated using the FQPA Index Reservoir Screening Tool (FIRST) Model. The surface 

water estimate was used for the acute assessment because this estimate was higher than the 

groundwater value. In contrast, the groundwater estimate was used for the chronic assessment, 

because this estimate was higher than the surface water value. Both acute and chronic estimates 

included parent and degradates. For the acute assessment, a value of 226 ppb was used, and for 

the chronic assessment, a value of 119 ppb was used. This value also includes both parent and 

degradates. For more information about EFED’s drinking water models, see 

http://www.epa.gov/oppefed1/models/ water. 

Table 3. Maximum Tier 1 Estimated Drinking Water Concentrations Based on Ground 

Application of Fluazinam to Turf at a Seasonal Rate of 8.4 lb a.i./A

Source/Model 

Fluazinam Total Residues of Fluazinam1

Acute/ppb Chronic/ppb Acute/ppb Chronic/ppb 

Surface Waters/FIRST 217 2 1.47 2262 37.8 

Groundwater/PRZM-GW 0.538 0.319 1372 1192

1. Including the following transformation products: DCPA, HYPA, CAPA, DAPA and AMPA.

2. Exceeds the solubility of fluazinam at pH 7 (71 ppb), but not the solubility at pH 11 (350 ppm). 

V. DEEM-FCID Program and Consumption Information

Fluazinam acute and chronic dietary exposure assessments were conducted using the Dietary 

Exposure Evaluation Model software with the Food Commodity Intake Database DEEM-FCID, 

Version 3.16, which incorporates 2003-2008 consumption data from USDA’s 

NHANES/WWEIA. The data are based on the reported consumption of more than 20,000 

individuals over two non-consecutive survey days. Foods “as consumed” (e.g., apple pie) are 

linked to EPA-defined food commodities (e.g. apples, peeled fruit - cooked; fresh or N/S; baked; 

or wheat flour - cooked; fresh or N/S, baked) using publicly available recipe translation files 

developed jointly by USDA/ARS and EPA. For chronic exposure assessment, consumption data 

are averaged for the entire U.S. population and within population subgroups. However, for acute 

exposure assessment, consumption data are retained as individual consumption events. Based on 

analysis of the 2003-2008 WWEIA consumption data, which took into account dietary patterns 

and survey respondents, HED concluded that it is most appropriate to report risk for the 

following population subgroups: the general U.S. population, all infants (<1 year old), children 

1-2, children 3-5, children 6-12, youth 13-19, adults 20-49, females 13-49, and adults 50-99 

years old. 

For chronic dietary exposure assessment, an estimate of the residue level in each food or foodform (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 
Fluazinam Dietary Exposure and Risk Assessment DP Number: D429506 

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estimates for all other food/food forms on the commodity residue list to arrive at the total 

average estimated exposure. Exposure is expressed in mg/kg body weight/day and as a percent 

of the cPAD. This procedure is performed for each population subgroup. 

For acute exposure assessments, individual one-day food consumption data are used on an 

individual-by-individual basis. The reported consumption amounts of each food item can be 

multiplied by a residue point estimate and summed to obtain a total daily pesticide exposure for a 

deterministic exposure assessment, or “matched” in multiple random pairings with residue values 

and then summed in a probabilistic assessment. The resulting distribution of exposures is 

expressed as a percentage of the aPAD on both a user (i.e., only those who reported eating 

relevant commodities/food forms) and a per-capita (i.e., those who reported eating the relevant 

commodities as well as those who did not) basis. In accordance with HED policy, per capita 

exposure and risk are reported for assessments performed at all levels of refinement. However, 

for unrefined assessments, any significant differences in user vs. per capita exposure and risk are 

specifically identified and noted in the risk assessment. 

VI. Toxicological Information 

The toxicity data show that the primary target organ for chronic exposure to fluazinam is the 

liver. Liver effects in mice served as the basis for the chronic dietary endpoint. Acute 

neurotoxicity was seen in rats, and developmental toxicity was seen in rabbits. For acute dietary 

exposure assessment, different endpoints were selected for the General U.S. population and 

Females 13-49. The FQPA Safety Factor was reduced to 1x for all population subgroups. The 

CARC determined that quantification of risk using a non-linear approach (i.e., RfD) will 

adequately account for all chronic toxicity, including carcinogenicity, that could result from 

exposure to fluazinam. The fluazinam doses and endpoints for use in dietary exposure 

assessments are summarized in Table 4. 

Table 4. Toxicological Doses and Endpoints for Fluazinam for Use in Dietary and Non-Occupational 

Human Health Risk Assessments 

Exposure/ 

Scenario 

Point of 

Departure 

Uncertainty/ 

FQPA Safety 

Factors 

RfD, PAD, Level 

of Concern for 

Risk Assessment 

Study and Toxicological Effects 

Acute 

Dietary 

(General 

population) 

NOAEL= 50 

mg/kg/day 

UFA= 10x 

UFH=10x 

FQPA SF=1x 

Acute RfD =0.5 

mg/kg/day 

aPAD 

= 0.5mg/kg/day 

Acute Neurotoxicity-Rats 

LOAEL = 1000 mg/kg/day based 

on decreased motor activity and 

soft stools on day of dosing. 

Acute 

Dietary 

(Females 13-

49 years of 

age) 

NOAEL 

(developmental) 

= 7 mg/kg/day 

UFA= 10x 

UFH=10x 

FQPA SF=1x 

Acute RfD =0.07 

mg/kg/day 

aPAD 

= 0.07mg/kg/day 

Developmental Toxicity- Rabbits 

Developmental LOAEL = 12 

mg/kg/day based on increased 

incidence of total litter 

resorptions and possibly 

increased incidence of fetal 

skeletal abnormalities. 
Fluazinam Dietary Exposure and Risk Assessment DP Number: D429506 

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Table 4. Toxicological Doses and Endpoints for Fluazinam for Use in Dietary and Non-Occupational 

Human Health Risk Assessments 

Exposure/ 

Scenario 

Point of 

Departure 

Uncertainty/ 

FQPA Safety 

Factors 

RfD, PAD, Level 

of Concern for 

Risk Assessment 

Study and Toxicological Effects 

Chronic 

Dietary (All 

Populations) 

NOAEL= 1.1 

mg/kg/day 

UFA= 10x 

UFH=10x 

FQPA SF=1x 

Chronic RfD 

=0.011 mg/kg/day 

cPAD 

= 0.011mg/kg/day 

Carcinogenicity-Mice 

LOAEL = 10.7 mg/kg/day based 

on liver histopathology and 

increased liver weight. 

Cancer (oral, 

dermal, 

inhalation) 

Classification: “Suggestive Evidence of Carcinogenicity, but not sufficient to assess human 

carcinogenic potential.” 

NOAEL = no observed adverse effect level. LOAEL = lowest observed adverse effect level. UF = uncertainty factor. UFA = 

extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among members of the human 

population (intraspecies). FQPA SF = FQPA Safety Factor. PAD = population adjusted dose (a = acute, c = chronic). RfD = 

reference dose. 

VII. Results/Discussion 

As stated above, for acute and chronic assessments, HED is concerned when dietary risk exceeds 

100% of the PAD. The DEEM-FCID analyses estimate the dietary exposure of the U.S. 

population and various population subgroups. The results reported in Table 5 are for the general 

U.S. population, all infants (<1 year old), children 1-2, children 3-5, children 6-12, youth 13-19, 

females 13-49, adults 20-49, and adults 50-99 years. Risk estimates are below HED’s level of 

concern for all population subgroups in both the acute and chronic analyses. 

The acute risk estimate for the General U.S. Population is 5.7% of the aPAD. The aPAD is 

lower for females 13 to 49 years old. Although Children 1-2 years old have the highest exposure 

estimate (0.112064 mg/kg/day; 22% aPAD), the population subgroup with the highest risk 

estimate is females 13 to 49 years old, which utilizes 32% of the aPAD (0.022220 mg/kg/day). 

The chronic risk estimate for the general U.S. population is 41% of the cPAD. The most highly 

exposed population subgroup is All Infants, which uses 92% of the cPAD. Finally, cancer 

dietary risk assessment was not required. 

Full listings of exposure and risk estimates are included in Attachments 2 (acute analysis) and 4 

(chronic analysis). 

Table 5. Summary of Acute and Chronic Exposure and Risk Estimates for Fluazinam 

Population Subgroup Acute Assessment (95th Percentile) Chronic Assessment 

aPAD, 

mg/kg/day 

Exposure 

Estimate, 

mg/kg/day 

% aPAD cPAD, 

mg/kg/day 

Exposure Estimate, 

mg/kg/day 

% 

cPAD 

U.S Population 0.5 0.028533 5.7 0.011 0.004521 41 

All infants* 0.5 0.085186 17 0.011 0.010122 92 

Children 1-2 yrs 0.5 0.112064 22 0.011 0.009750 89 

Children 3-5 yrs 0.5 0.065310 13 0.011 0.006614 60 

Children 6-12 yrs 0.5 0.034218 6.8 0.011 0.004161 38 
Fluazinam Dietary Exposure and Risk Assessment DP Number: D429506 

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Table 5. Summary of Acute and Chronic Exposure and Risk Estimates for Fluazinam 

Population Subgroup Acute Assessment (95th Percentile) Chronic Assessment 

aPAD, 

mg/kg/day 

Exposure 

Estimate, 

mg/kg/day 

% aPAD cPAD, 

mg/kg/day 

Exposure Estimate, 

mg/kg/day 

% 

cPAD 

Youth 13-19 yrs 0.5 0.019517 3.9 0.011 0.002981 27 

Adults 20-49 yrs 0.5 0.021791 4.4 0.011 0.004243 39 

Adults 50-99 yrs 0.5 0.019444 3.9 0.011 0.004490 41 

Females 13-49 yrs* 0.07 0.022220 32 0.011 0.004338 39 

*The subpopulation with the highest acute or chronic risk estimate 

VIII. Characterization of Inputs/Outputs

HED considers both the acute and chronic assessments to be very conservative. The acute 

assessment is based on tolerance-level residues for all commodities, with worst-case assumptions 

being made for residue levels of the metabolite AMGT. In addition, it was assumed that 100% 

of all crops with registered or requested uses of fluazinam will be treated. The EDWCs include 

parent fluazinam and its transformation products. The acute assessment assumed that the 

degradates were as toxic as parent fluazinam. These same assumptions and inputs were used for 

the chronic assessment, except that an average field trial value was used for apples. These 

assumptions result in highly conservative, health-protective estimates of exposure and risk. In 

the event that refinements need to be made in the future, percent crop treated estimates, average 

field trial values, and monitoring data can be incorporated into the assessments. 

IX. Conclusions

The exposure estimates generated by the dietary exposure model that was used are conservative 

estimates of dietary exposure. Even so, the acute and chronic aggregate (food + drinking water) 

dietary risk estimates for the general U.S. population and all population subgroups are not of 

concern. The chronic dietary exposure assessment is protective for cancer. Cancer risk is also 

not of concern. 

X. List of Attachments 

Attachment 1. Acute Dietary Residue Input File for Fluazinam 

Attachment 2. Results of Acute Dietary Exposure Assessment 

Attachment 3. Chronic Dietary Residue Input File for Fluazinam 

Attachment 4. Results of Chronic Dietary Exposure Assessment 

 
Fluazinam Dietary Exposure and Risk Assessment DP Number: D429506 

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Attachment 1: Acute Dietary Residue Input File for Fluazinam 

DEEM FCID Version 3.16 

Acute NOAEL for general population including infants and children: 50 mg/kg bw/day 

Acute PAD for general population including infants and children: 0.5 mg/kg bw/day 

Acute NOAEL for Females 13-49: 7 mg/kg bw/day 

Acute PAD for Females 13-49: 0.07 mg/kg bw/day 

Filename: F:\Fluazinam\Fluazinam2012acute_111615.R08 Chemical: Fluazinam 

RfD(Chronic): .011 mg/kg bw/day NOEL(Chronic): 0 mg/kg bw/day 

RfD(Acute): .5 mg/kg bw/day NOEL(Acute): 0 mg/kg bw/day 

Date created/last modified: 11-16-2015/15:04:23 Program ver. 3.16, 03-08-d 

Comment: aPAD of 0.5 kg/day is for general pop. Female 13-49 aPAD = 0.07 mg/day 

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

 EPA Crop Def Res Adj.Factors Comment 

 Code Grp Commodity Name (ppm) #1 #2 

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

0101078000 1AB Carrot 0.700000 1.000 1.000 

0101078001 1AB Carrot-babyfood 0.700000 1.000 1.000 

0101079000 1AB Carrot, juice 0.700000 1.000 1.000 

0101168000 1AB Ginseng, dried 4.500000 1.000 1.000 

0103015000 1CD Arrowroot, flour 0.020000 1.000 1.000 

0103015001 1CD Arrowroot, flour-babyfood 0.020000 1.000 1.000 

0103017000 1CD Artichoke, Jerusalem 0.020000 1.000 1.000 

0103082000 1CD Cassava 0.020000 1.000 1.000 

0103082001 1CD Cassava-babyfood 0.020000 1.000 1.000 

0103139000 1CD Dasheen, corm 0.020000 1.000 1.000 

0103166000 1CD Ginger 0.020000 1.000 1.000 

0103166001 1CD Ginger-babyfood 0.020000 1.000 1.000 

0103167000 1CD Ginger, dried 0.020000 1.000 1.000 

0103296000 1C Potato, chips 0.020000 1.000 1.000 

0103297000 1C Potato, dry (granules/ flakes) 0.020000 6.500 1.000 

0103297001 1C Potato, dry (granules/ flakes)-b 0.020000 6.500 1.000 

0103298000 1C Potato, flour 0.020000 6.500 1.000 

0103298001 1C Potato, flour-babyfood 0.020000 6.500 1.000 

0103299000 1C Potato, tuber, w/peel 0.020000 1.000 1.000 

0103299001 1C Potato, tuber, w/peel-babyfood 0.020000 1.000 1.000 

0103300000 1C Potato, tuber, w/o peel 0.020000 1.000 1.000 

0103300001 1C Potato, tuber, w/o peel-babyfood 0.020000 1.000 1.000 

0103366000 1CD Sweet potato 0.020000 1.000 1.000 

0103366001 1CD Sweet potato-babyfood 0.020000 1.000 1.000 

0103371000 1CD Tanier, corm 0.020000 1.000 1.000 

0103387000 1CD Turmeric 0.020000 1.000 1.000 

0103406000 1CD Yam, true 0.020000 1.000 1.000 

0103407000 1CD Yam bean 0.020000 1.000 1.000 

0301165000 3A Garlic, bulb 0.200000 1.000 1.000 

0301165001 3A Garlic, bulb-babyfood 0.200000 1.000 1.000 

0301237000 3A Onion, bulb 0.200000 1.000 1.000 

0301237001 3A Onion, bulb-babyfood 0.200000 1.000 1.000 

0301238000 3A Onion, bulb, dried 0.200000 9.000 1.000 

0301238001 3A Onion, bulb, dried-babyfood 0.200000 9.000 1.000 

0301338000 3A Shallot, bulb 0.200000 1.000 1.000 

0401204000 4A Lettuce, head 0.027000 1.000 1.000 

0401205000 4A Lettuce, leaf 2.700000 1.000 1.000 

0501061000 5A Broccoli 0.013500 1.000 1.000 

0501061001 5A Broccoli-babyfood 0.013500 1.000 1.000 

0501062000 5A Broccoli, Chinese 0.013500 1.000 1.000 

0501064000 5A Brussels sprouts 0.013500 1.000 1.000 

0501069000 5A Cabbage 3.010000 1.000 1.000 

0501071000 5A Cabbage, Chinese, napa 3.010000 1.000 1.000 
Fluazinam Dietary Exposure and Risk Assessment DP Number: D429506 

Page 11 of 17 

0501072000 5A Cabbage, Chinese, mustard 0.013500 1.000 1.000 

0501083000 5A Cauliflower 0.013500 1.000 1.000 

0501196000 5A Kohlrabi 0.013500 1.000 1.000 

0502063000 5B Broccoli raab 0.013500 1.000 1.000 

0502070000 5B Cabbage, Chinese, bok choy 0.013500 1.000 1.000 

0502117000 5B Collards 0.013500 1.000 1.000 

0502194000 5B Kale 0.013500 1.000 1.000 

0502229000 5B Mustard greens 0.013500 1.000 1.000 

0502318000 5B Rape greens 0.013500 1.000 1.000 

0502389000 5B Turnip, greens 0.013500 1.000 1.000 

0600347000 6 Soybean, seed 0.020000 1.000 1.000 

0600349000 6 Soybean, soy milk 0.020000 1.000 1.000 

0600349001 6 Soybean, soy milk-babyfood or in 0.020000 1.000 1.000 

0600350000 6 Soybean, oil 0.020000 1.000 1.000 

0600350001 6 Soybean, oil-babyfood 0.020000 1.000 1.000 

0601043000 6A Bean, snap, succulent 0.135000 1.000 1.000 

0601043001 6A Bean, snap, succulent-babyfood 0.135000 1.000 1.000 

0601349500 6AB Soybean, vegetable 0.135000 1.000 1.000 

0602031000 6B Bean, broad, succulent 0.054000 1.000 1.000 

0602033000 6B Bean, cowpea, succulent 0.054000 1.000 1.000 

0602037000 6B Bean, lima, succulent 0.054000 1.000 1.000 

0603030000 6C Bean, black, seed 0.027000 1.000 1.000 

0603032000 6C Bean, broad, seed 0.027000 1.000 1.000 

0603034000 6C Bean, cowpea, seed 0.027000 1.000 1.000 

0603035000 6C Bean, great northern, seed 0.027000 1.000 1.000 

0603036000 6C Bean, kidney, seed 0.027000 1.000 1.000 

0603038000 6C Bean, lima, seed 0.027000 1.000 1.000 

0603039000 6C Bean, mung, seed 0.027000 1.000 1.000 

0603040000 6C Bean, navy, seed 0.027000 1.000 1.000 

0603041000 6C Bean, pink, seed 0.027000 1.000 1.000 

0603042000 6C Bean, pinto, seed 0.027000 1.000 1.000 

0603098000 6C Chickpea, seed 0.027000 1.000 1.000 

0603098001 6C Chickpea, seed-babyfood 0.027000 1.000 1.000 

0603099000 6C Chickpea, flour 0.027000 1.000 1.000 

0603182000 6C Guar, seed 0.027000 1.000 1.000 

0603182001 6C Guar, seed-babyfood 0.027000 1.000 1.000 

0603348000 6C Soybean, flour 0.020000 1.000 1.000 

0603348001 6C Soybean, flour-babyfood 0.020000 1.000 1.000 

0802148000 8BC Eggplant 0.100000 1.000 1.000 

0802234000 8BC Okra 0.100000 1.000 1.000 

0802270000 8B Pepper, bell 0.100000 1.000 1.000 

0802270001 8B Pepper, bell-babyfood 0.100000 1.000 1.000 

0802271000 8B Pepper, bell, dried 0.100000 1.000 1.000 

0802271001 8B Pepper, bell, dried-babyfood 0.100000 1.000 1.000 

0802272000 8BC Pepper, nonbell 0.100000 1.000 1.000 

0802272001 8BC Pepper, nonbell-babyfood 0.100000 1.000 1.000 

0802273000 8BC Pepper, nonbell, dried 0.100000 1.000 1.000 

0901075000 9A Cantaloupe 0.080000 1.000 1.000 

0901187000 9A Honeydew melon 0.080000 1.000 1.000 

0901399000 9A Watermelon 0.080000 1.000 1.000 

0901400000 9A Watermelon, juice 0.080000 1.000 1.000 

0902021000 9B Balsam pear 0.080000 1.000 1.000 

0902088000 9B Chayote, fruit 0.080000 1.000 1.000 

0902102000 9B Chinese waxgourd 0.080000 1.000 1.000 

0902135000 9B Cucumber 0.080000 1.000 1.000 

0902308000 9B Pumpkin 0.080000 1.000 1.000 

0902309000 9B Pumpkin, seed 0.080000 1.000 1.000 

0902356000 9B Squash, summer 0.080000 1.000 1.000 

0902356001 9B Squash, summer-babyfood 0.080000 1.000 1.000 

0902357000 9B Squash, winter 0.080000 1.000 1.000 

0902357001 9B Squash, winter-babyfood 0.080000 1.000 1.000 

1100007000 11 Apple, fruit with peel 2.000000 1.000 1.000 

1100008000 11 Apple, peeled fruit 2.000000 1.000 1.000 

1100008001 11 Apple, peeled fruit-babyfood 2.000000 1.000 1.000 

1100009000 11 Apple, dried 2.000000 8.000 1.000 

1100009001 11 Apple, dried-babyfood 2.000000 8.000 1.000 

1100010000 11 Apple, juice 2.000000 1.300 1.000 
Fluazinam Dietary Exposure and Risk Assessment DP Number: D429506 

Page 12 of 17 

1100010001 11 Apple, juice-babyfood 2.000000 1.300 1.000 

1100011000 11 Apple, sauce 2.000000 1.000 1.000 

1100011001 11 Apple, sauce-babyfood 2.000000 1.000 1.000 

1302057000 13B Blueberry 7.800000 1.000 1.000 

1302057001 13B Blueberry-babyfood 7.800000 1.000 1.000 

1302136000 13B Currant 7.800000 1.000 1.000 

1302137000 13B Currant, dried 7.800000 1.000 1.000 

1302149000 13B Elderberry 7.800000 1.000 1.000 

1302174000 13B Gooseberry 7.800000 1.000 1.000 

1302191000 13B Huckleberry 7.800000 1.000 1.000 

1304179000 13D Grape, wine and sherry 3.000000 1.000 1.000 

1307130000 13G Cranberry 7.800000 1.000 1.000 

1307130001 13G Cranberry-babyfood 7.800000 1.000 1.000 

1307131000 13G Cranberry, dried 7.800000 1.000 1.000 

1307132000 13G Cranberry, juice 7.800000 1.100 1.000 

1307132001 13G Cranberry, juice-babyfood 7.800000 1.100 1.000 

3100046000 31 Beef, meat byproducts 0.050000 1.000 1.000 

3100046001 31 Beef, meat byproducts-babyfood 0.050000 1.000 1.000 

3100047000 31 Beef, fat 0.050000 1.000 1.000 

3100047001 31 Beef, fat-babyfood 0.050000 1.000 1.000 

3100048000 31 Beef, kidney 0.050000 1.000 1.000 

3100049000 31 Beef, liver 0.050000 1.000 1.000 

3100049001 31 Beef, liver-babyfood 0.050000 1.000 1.000 

3200170000 32 Goat, meat byproducts 0.050000 1.000 1.000 

3200171000 32 Goat, fat 0.050000 1.000 1.000 

3200172000 32 Goat, kidney 0.050000 1.000 1.000 

3200173000 32 Goat, liver 0.050000 1.000 1.000 

3500340000 35 Sheep, meat byproducts 0.050000 1.000 1.000 

3500341000 35 Sheep, fat 0.050000 1.000 1.000 

3500341001 35 Sheep, fat-babyfood 0.050000 1.000 1.000 

3500342000 35 Sheep, kidney 0.050000 1.000 1.000 

3500343000 35 Sheep, liver 0.050000 1.000 1.000 

8601000000 86A Water, direct, all sources 0.226000 1.000 1.000 

8602000000 86B Water, indirect, all sources 0.226000 1.000 1.000 

9500263000 O Peanut 0.020000 1.000 1.000 

9500264000 O Peanut, butter 0.020000 1.890 1.000 

9500265000 O Peanut, oil 0.020000 1.000 1.000 

 
Fluazinam Dietary Exposure and Risk Assessment DP Number: D429506 

Page 13 of 17 

Attachment 2: Results of Acute Dietary Exposure Assessment 

US EPA Ver. 3.18, 03-08-d 

DEEM-FCID ACUTE Analysis for FLUAZINAM NHANES 2003-2008 2-Day 

Residue file: Fluazinam2012acute_111615.R08 Adjustment factor #2 NOT used. 

Analysis Date: 11-16-2015/16:28:19 Residue file dated: 11-16-2015/15:04:23 

Acute Pop Adjusted Dose (aPAD) varies with population; see individual reports 

RAC/FF intake summed over 24 hours 

Run Comment: "aPAD of 0.5 kg/day is for general pop. Female 13-49 aPAD = 0.07 

 mg/day" 

=============================================================================== 

Summary calculations--per capita: 

 95th Percentile 99th Percentile 99.9th Percentile 

 Exposure % aPAD Exposure % aPAD Exposure % aPAD 

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

Total US Population: 

 0.028533 5.71 0.065050 13.01 0.158547 31.71 

All Infants: 

 0.085186 17.04 0.154200 30.84 0.287216 57.44 

Children 1-2: 

 0.112064 22.41 0.192396 38.48 0.310428 62.09 

Children 3-5: 

 0.065310 13.06 0.120591 24.12 0.204321 40.86 

Children 6-12: 

 0.034218 6.84 0.068100 13.62 0.122136 24.43 

Youth 13-19: 

 0.019517 3.90 0.036854 7.37 0.059213 11.84 

Adults 20-49: 

 0.021791 4.36 0.035015 7.00 0.073850 14.77 

Adults 50-99: 

 0.019444 3.89 0.031316 6.26 0.051628 10.33 

Female 13-49: 

 0.022220 31.74 0.036769 52.53 0.079600 113.71 

 
Fluazinam Dietary Exposure and Risk Assessment DP Number: D429506 

Page 14 of 17 

Attachment 3: Chronic Dietary Residue Input File for Fluazinam 

DEEM FCID Version 3.16 

Chronic NOAEL: 1.1 mg/kg bw/day 

Chronic PAD: 0.011 mg/kg bw/day 

Filename: F:\Fluazinam\Fluazinam2015chronic_111615.R08 Chemical: Fluazinam 

RfD(Chronic): .011 mg/kg bw/day NOEL(Chronic): 0 mg/kg bw/day 

RfD(Acute): .5 mg/kg bw/day NOEL(Acute): 0 mg/kg bw/day 

Date created/last modified: 11-16-2015/15:05:13 Program ver. 3.16, 03-08-d 

Comment: aPAD of 0.5 kg/day is for general pop. Female 13-49 aPAD = 0.07 mg/day 

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

 EPA Crop Def Res Adj.Factors Comment 

 Code Grp Commodity Name (ppm) #1 #2 

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

0101078000 1AB Carrot 0.700000 1.000 1.000 

0101078001 1AB Carrot-babyfood 0.700000 1.000 1.000 

0101079000 1AB Carrot, juice 0.700000 1.000 1.000 

0101168000 1AB Ginseng, dried 4.500000 1.000 1.000 

0103015000 1CD Arrowroot, flour 0.020000 1.000 1.000 

0103015001 1CD Arrowroot, flour-babyfood 0.020000 1.000 1.000 

0103017000 1CD Artichoke, Jerusalem 0.020000 1.000 1.000 

0103082000 1CD Cassava 0.020000 1.000 1.000 

0103082001 1CD Cassava-babyfood 0.020000 1.000 1.000 

0103139000 1CD Dasheen, corm 0.020000 1.000 1.000 

0103166000 1CD Ginger 0.020000 1.000 1.000 

0103166001 1CD Ginger-babyfood 0.020000 1.000 1.000 

0103167000 1CD Ginger, dried 0.020000 1.000 1.000 

0103296000 1C Potato, chips 0.020000 1.000 1.000 

0103297000 1C Potato, dry (granules/ flakes) 0.020000 6.500 1.000 

0103297001 1C Potato, dry (granules/ flakes)-b 0.020000 6.500 1.000 

0103298000 1C Potato, flour 0.020000 6.500 1.000 

0103298001 1C Potato, flour-babyfood 0.020000 6.500 1.000 

0103299000 1C Potato, tuber, w/peel 0.020000 1.000 1.000 

0103299001 1C Potato, tuber, w/peel-babyfood 0.020000 1.000 1.000 

0103300000 1C Potato, tuber, w/o peel 0.020000 1.000 1.000 

0103300001 1C Potato, tuber, w/o peel-babyfood 0.020000 1.000 1.000 

0103366000 1CD Sweet potato 0.020000 1.000 1.000 

0103366001 1CD Sweet potato-babyfood 0.020000 1.000 1.000 

0103371000 1CD Tanier, corm 0.020000 1.000 1.000 

0103387000 1CD Turmeric 0.020000 1.000 1.000 

0103406000 1CD Yam, true 0.020000 1.000 1.000 

0103407000 1CD Yam bean 0.020000 1.000 1.000 

0301165000 3A Garlic, bulb 0.200000 1.000 1.000 

0301165001 3A Garlic, bulb-babyfood 0.200000 1.000 1.000 

0301237000 3A Onion, bulb 0.200000 1.000 1.000 

0301237001 3A Onion, bulb-babyfood 0.200000 1.000 1.000 

0301238000 3A Onion, bulb, dried 0.200000 9.000 1.000 

0301238001 3A Onion, bulb, dried-babyfood 0.200000 9.000 1.000 

0301338000 3A Shallot, bulb 0.200000 1.000 1.000 

0401204000 4A Lettuce, head 0.027000 1.000 1.000 

0401205000 4A Lettuce, leaf 2.700000 1.000 1.000 

0501061000 5A Broccoli 0.013500 1.000 1.000 

0501061001 5A Broccoli-babyfood 0.013500 1.000 1.000 

0501062000 5A Broccoli, Chinese 0.013500 1.000 1.000 

0501064000 5A Brussels sprouts 0.013500 1.000 1.000 

0501069000 5A Cabbage 3.010000 1.000 1.000 

0501071000 5A Cabbage, Chinese, napa 3.010000 1.000 1.000 

0501072000 5A Cabbage, Chinese, mustard 0.013500 1.000 1.000 

0501083000 5A Cauliflower 0.013500 1.000 1.000 

0501196000 5A Kohlrabi 0.013500 1.000 1.000 

0502063000 5B Broccoli raab 0.013500 1.000 1.000 

0502070000 5B Cabbage, Chinese, bok choy 0.013500 1.000 1.000 
Fluazinam Dietary Exposure and Risk Assessment DP Number: D429506 

Page 15 of 17 

0502117000 5B Collards 0.013500 1.000 1.000 

0502194000 5B Kale 0.013500 1.000 1.000 

0502229000 5B Mustard greens 0.013500 1.000 1.000 

0502318000 5B Rape greens 0.013500 1.000 1.000 

0502389000 5B Turnip, greens 0.013500 1.000 1.000 

0600347000 6 Soybean, seed 0.020000 1.000 1.000 

0600349000 6 Soybean, soy milk 0.020000 1.000 1.000 

0600349001 6 Soybean, soy milk-babyfood or in 0.020000 1.000 1.000 

0600350000 6 Soybean, oil 0.020000 1.000 1.000 

0600350001 6 Soybean, oil-babyfood 0.020000 1.000 1.000 

0601043000 6A Bean, snap, succulent 0.135000 1.000 1.000 

0601043001 6A Bean, snap, succulent-babyfood 0.135000 1.000 1.000 

0601349500 6AB Soybean, vegetable 0.135000 1.000 1.000 

0602031000 6B Bean, broad, succulent 0.054000 1.000 1.000 

0602033000 6B Bean, cowpea, succulent 0.054000 1.000 1.000 

0602037000 6B Bean, lima, succulent 0.054000 1.000 1.000 

0603030000 6C Bean, black, seed 0.027000 1.000 1.000 

0603032000 6C Bean, broad, seed 0.027000 1.000 1.000 

0603034000 6C Bean, cowpea, seed 0.027000 1.000 1.000 

0603035000 6C Bean, great northern, seed 0.027000 1.000 1.000 

0603036000 6C Bean, kidney, seed 0.027000 1.000 1.000 

0603038000 6C Bean, lima, seed 0.027000 1.000 1.000 

0603039000 6C Bean, mung, seed 0.027000 1.000 1.000 

0603040000 6C Bean, navy, seed 0.027000 1.000 1.000 

0603041000 6C Bean, pink, seed 0.027000 1.000 1.000 

0603042000 6C Bean, pinto, seed 0.027000 1.000 1.000 

0603098000 6C Chickpea, seed 0.027000 1.000 1.000 

0603098001 6C Chickpea, seed-babyfood 0.027000 1.000 1.000 

0603099000 6C Chickpea, flour 0.027000 1.000 1.000 

0603182000 6C Guar, seed 0.027000 1.000 1.000 

0603182001 6C Guar, seed-babyfood 0.027000 1.000 1.000 

0603348000 6C Soybean, flour 0.020000 1.000 1.000 

0603348001 6C Soybean, flour-babyfood 0.020000 1.000 1.000 

0802148000 8BC Eggplant 0.100000 1.000 1.000 

0802234000 8BC Okra 0.100000 1.000 1.000 

0802270000 8B Pepper, bell 0.100000 1.000 1.000 

0802270001 8B Pepper, bell-babyfood 0.100000 1.000 1.000 

0802271000 8B Pepper, bell, dried 0.100000 1.000 1.000 

0802271001 8B Pepper, bell, dried-babyfood 0.100000 1.000 1.000 

0802272000 8BC Pepper, nonbell 0.100000 1.000 1.000 

0802272001 8BC Pepper, nonbell-babyfood 0.100000 1.000 1.000 

0802273000 8BC Pepper, nonbell, dried 0.100000 1.000 1.000 

0901075000 9A Cantaloupe 0.080000 1.000 1.000 

0901187000 9A Honeydew melon 0.080000 1.000 1.000 

0901399000 9A Watermelon 0.080000 1.000 1.000 

0901400000 9A Watermelon, juice 0.080000 1.000 1.000 

0902021000 9B Balsam pear 0.080000 1.000 1.000 

0902088000 9B Chayote, fruit 0.080000 1.000 1.000 

0902102000 9B Chinese waxgourd 0.080000 1.000 1.000 

0902135000 9B Cucumber 0.080000 1.000 1.000 

0902308000 9B Pumpkin 0.080000 1.000 1.000 

0902309000 9B Pumpkin, seed 0.080000 1.000 1.000 

0902356000 9B Squash, summer 0.080000 1.000 1.000 

0902356001 9B Squash, summer-babyfood 0.080000 1.000 1.000 

0902357000 9B Squash, winter 0.080000 1.000 1.000 

0902357001 9B Squash, winter-babyfood 0.080000 1.000 1.000 

1100007000 11 Apple, fruit with peel 0.215000 1.000 1.000 

1100008000 11 Apple, peeled fruit 0.215000 1.000 1.000 

1100008001 11 Apple, peeled fruit-babyfood 0.215000 1.000 1.000 

1100009000 11 Apple, dried 0.215000 8.000 1.000 

1100009001 11 Apple, dried-babyfood 0.215000 8.000 1.000 

1100010000 11 Apple, juice 0.215000 1.300 1.000 

1100010001 11 Apple, juice-babyfood 0.215000 1.300 1.000 

1100011000 11 Apple, sauce 0.215000 1.000 1.000 

1100011001 11 Apple, sauce-babyfood 0.215000 1.000 1.000 

1302057000 13B Blueberry 7.800000 1.000 1.000 

1302057001 13B Blueberry-babyfood 7.800000 1.000 1.000 
Fluazinam Dietary Exposure and Risk Assessment DP Number: D429506 

Page 16 of 17 

1302136000 13B Currant 7.800000 1.000 1.000 

1302137000 13B Currant, dried 7.800000 1.000 1.000 

1302149000 13B Elderberry 7.800000 1.000 1.000 

1302174000 13B Gooseberry 7.800000 1.000 1.000 

1302191000 13B Huckleberry 7.800000 1.000 1.000 

1304179000 13D Grape, wine and sherry 3.000000 1.000 1.000 

1307130000 13G Cranberry 7.800000 1.000 1.000 

1307130001 13G Cranberry-babyfood 7.800000 1.000 1.000 

1307131000 13G Cranberry, dried 7.800000 1.000 1.000 

1307132000 13G Cranberry, juice 7.800000 1.100 1.000 

1307132001 13G Cranberry, juice-babyfood 7.800000 1.100 1.000 

3100046000 31 Beef, meat byproducts 0.050000 1.000 1.000 

3100046001 31 Beef, meat byproducts-babyfood 0.050000 1.000 1.000 

3100047000 31 Beef, fat 0.050000 1.000 1.000 

3100047001 31 Beef, fat-babyfood 0.050000 1.000 1.000 

3100048000 31 Beef, kidney 0.050000 1.000 1.000 

3100049000 31 Beef, liver 0.050000 1.000 1.000 

3100049001 31 Beef, liver-babyfood 0.050000 1.000 1.000 

3200170000 32 Goat, meat byproducts 0.050000 1.000 1.000 

3200171000 32 Goat, fat 0.050000 1.000 1.000 

3200172000 32 Goat, kidney 0.050000 1.000 1.000 

3200173000 32 Goat, liver 0.050000 1.000 1.000 

3500340000 35 Sheep, meat byproducts 0.050000 1.000 1.000 

3500341000 35 Sheep, fat 0.050000 1.000 1.000 

3500341001 35 Sheep, fat-babyfood 0.050000 1.000 1.000 

3500342000 35 Sheep, kidney 0.050000 1.000 1.000 

3500343000 35 Sheep, liver 0.050000 1.000 1.000 

8601000000 86A Water, direct, all sources 0.119000 1.000 1.000 

8602000000 86B Water, indirect, all sources 0.119000 1.000 1.000 

9500263000 O Peanut 0.020000 1.000 1.000 

9500264000 O Peanut, butter 0.020000 1.890 1.000 

9500265000 O Peanut, oil 0.020000 1.000 1.000 

 
Fluazinam Dietary Exposure and Risk Assessment DP Number: D429506 

Page 17 of 17 

Attachment 4: Results of Chronic Dietary Exposure Assessment 

US EPA Ver. 3.16, 03-08-d 

DEEM-FCID Chronic analysis for FLUAZINAM NHANES 2003-2008 2-day 

Residue file name: F:\Fluazinam\Fluazinam2015chronic_111615.R08 

 Adjustment factor #2 NOT used. 

Analysis Date 11-16-2015/15:31:43 Residue file dated: 11-16-2015/15:05:13 

Reference dose (RfD, Chronic) = .011 mg/kg bw/day 

COMMENT 1: aPAD of 0.5 kg/day is for general pop. Female 13-49 aPAD = 0.07 mg/day 

=============================================================================== 

 Total exposure by population subgroup 

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

 Total Exposure 

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

 Population mg/kg Percent of 

 Subgroup body wt/day Rfd 

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

Total US Population 0.004521 41.1% 

Hispanic 0.004005 36.4% 

Non-Hisp-White 0.004701 42.7% 

Non-Hisp-Black 0.003868 35.2% 

Non-Hisp-Other 0.005004 45.5% 

Nursing Infants 0.004234 38.5% 

Non-Nursing Infants 0.012751 115.9% 

Female 13+ PREG 0.003598 32.7% 

Children 1-6 0.007538 68.5% 

Children 7-12 0.003927 35.7% 

Male 13-19 0.002809 25.5% 

Female 13-19/NP 0.003155 28.7% 

Male 20+ 0.003928 35.7% 

Female 20+/NP 0.004752 43.2% 

Seniors 55+ 0.004539 41.3% 

All Infants 0.010122 92.0% 

Female 13-50 0.004346 39.5% 

Children 1-2 0.009750 88.6% 

Children 3-5 0.006614 60.1% 

Children 6-12 0.004161 37.8% 

Youth 13-19 0.002981 27.1% 

Adults 20-49 0.004243 38.6% 

Adults 50-99 0.004490 40.8% 

Female 13-49 0.004338 39.4% 

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