UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C. 20460

OFFICE OF CHEMICAL SAFETY 

AND POLLUTION PREVENTION 

MEMORANDUM

Date: 9/7/2012

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

Exposure and Risk Assessments for the Section 3 Registration Action on 

Soybeans, the Melon Subgroup (9A), and the Pepper/Eggplant Subgroup (8-10B)

PC Code: 129098 DP Barcode: D397722

Decision Nos.: 459107 Registration No.: 71512-1

Petition: 1E7959, 2F7977 Regulatory Action: Section 3 Registration

Risk Assessment Type: Dietary Case No.: 7013

TXR No.: NA CAS No.: 79622-59-6

MRID No.: NA 40 CFR: §180.574

 

FROM: Douglas Dotson, Ph.D., Chemist

Risk Assessment Branch II

Health Effects Division (7509P)

THROUGH: Nancy Dodd, Chemist

Ideliz Negrón-Encarnación, Ph.D., Chemist

Dietary Exposure Science Advisory Council

and

Christina Swartz, Branch Chief

Risk Assessment Branch II

Health Effects Division (7509P)

TO: Andrew Ertman/Barbara Madden, RM Team 5, RIMUERB

Dominic Schuler/Tony Kish, PM Team 22, Fungicide Branch

Registration Division (7505P)
Fluazinam Dietary Exposure and Risk Assessment DP Number: D397722

Page 2 of 17

Executive Summary

Acute and chronic aggregate dietary (food and drinking water) exposure and risk assessments 

were conducted using the Dietary Exposure Evaluation Model DEEM-FCID, Version 3.16 which 

uses food consumption data from the U.S. Department of Agriculture’s National Health and 

Nutrition Examination Survey, What We Eat in America, (NHANES/WWEIA). This dietary

survey was conducted from 2003 to 2008. The analyses were conducted as part of a human 

health risk assessment for the proposed use of fluazinam on soybeans, the melon subgroup (9B) 

and the pepper/eggplant subgroup (8-10B). The estimated drinking water concentrations 

(EDWCs) are based on a currently registered use on turf.

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 estimated drinking water concentrations (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 population-adjusted dose (PAD). The acute risk estimate for the 

general U.S. population is 5.3% of the acute PAD (aPAD). The population subgroup with the 

highest acute dietary risk estimate is Females 13-49, which uses 28% of the aPAD.

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 20% of the chronic 

PAD (cPAD). The most highly exposed population subgroup is Children 1-2, which uses 51% 

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 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 the 

point of departure (e.g., POD, NOAEL, or LOAEL) divided by the required uncertainty or safety 

factors.
Fluazinam Dietary Exposure and Risk Assessment DP Number: D397722

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

exceeds 100% of the PAD. References which discuss the acute and chronic risk assessments in 

more detail are available on the EPA/pesticides web site: “Available Information on Assessing 

Exposure from Pesticides, A User’s Guide,” 21 Jun 2000, web link: http://www.epa.gov/ 

fedrgstr/EPA-PEST/2000/July/Day-12/6061.pdf; or see SOP 99.6 (20 Aug 1999). The most 

recent dietary risk assessment for fluazinam was conducted by D. Dotson (D394960, 2/7/2012).

II. Residue Information

Fluazinam is currently registered in the U.S. for use on carrots, 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 for the 

Brassica leafy vegetables and turnip greens to 7.0 ppm for the Bushberry subgroup. 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. 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. 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.

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 petitions (soybeans, cantaloupe, and peppers), 

residues of parent fluazinam as well as residues of AMGT were measured in the field trial 

studies. For these commodities, the 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 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. 

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 
Fluazinam Dietary Exposure and Risk Assessment DP Number: D397722

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used in the dietary exposure assessments, see the last 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. 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)

Potatoes 0.02 0.02 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 0.01 0.0135 0.01 tolerance x 1.35

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

Peanuts 0.02 0.02 Tolerance (parent only)

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

Melons (9A) 0.07 0.08 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
Fluazinam Dietary Exposure and Risk Assessment DP Number: D397722

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Residues in Fish

Tolerances have not been established for 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 any 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; D391184, J. Meléndez, 8/3/2011) and 

incorporated directly into this dietary assessment into the food categories “water, direct, all 

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 2, below. The groundwater value was generated using the 

Screening Concentration in Groundwater (SCI-GROW) Model and the surface water values were 

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

estimates were used for both the acute and chronic assessments because they were higher than 

the groundwater 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 

37.8 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 2. 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 Water/FIRST 217 21.47 226 237.8

Groundwater/SCI-GROW 0.404

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).
Fluazinam Dietary Exposure and Risk Assessment DP Number: D397722

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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 consumption data from USDA’s NHANES/WWEIA. This 

dietary survey was conducted from 2003 to 2008. The data are based on the reported 

consumption of more than 20,000 individuals over two non-consecutive survey days. Foods “as 

consumed” (e.g., apple pie) are linked to EPA-defined food commodities (e.g. apples, peeled 

fruit - cooked; fresh or N/S; baked; or wheat flour - cooked; fresh or N/S, baked) using publicly 

available recipe translation files developed jointly by USDA/ARS and EPA. For chronic 

exposure assessment, consumption data are averaged for the entire U.S. population and within 

population subgroups. 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 

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 
Fluazinam Dietary Exposure and Risk Assessment DP Number: D397722

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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 3.

Table 3. 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.

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-FCIDTM analyses estimate the dietary exposure of the U.S. 

population and various population subgroups. The results reported in Table 4 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 5.3% of the aPAD. The population subgroup with the 

highest acute risk estimate is Females 13-49, which uses 28% of the aPAD. Although Females 

13-49 use the greatest percent of the aPAD, the population subgroup with the highest exposure is 

Children 1-2. Children 1-2 uses 21% of the aPAD. The reason this subgroup has a higher 

exposure but a lower % aPAD value than Females 13-49 is that it has a higher aPAD value than 

Females 13-49 (0.5 mg/kg/day for Children 1-2 as opposed to 0.07 mg/kg/day for Females 13-

49).
Fluazinam Dietary Exposure and Risk Assessment DP Number: D397722

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The chronic risk estimate for the general U.S. population is 20% of the cPAD. The most highly 

exposed population subgroup is Children 1-2, which uses 51% of the cPAD. Finally, cancer risk 

is not of concern.

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

(chronic analysis).

Table 4. 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 0.026393 5.3 0.011 0.002145 20

All infants 0.5 0.083776 17 0.011 0.004928 45

Children 1-2 yrs* 0.5 0.106710 21 0.011 0.005635 51

Children 3-5 yrs 0.5 0.064022 13 0.011 0.003751 34

Children 6-12 yrs 0.5 0.031323 6.3 0.011 0.002031 18

Youth 13-19 yrs 0.5 0.017332 3.5 0.011 0.001171 11

Adults 20-49 yrs 0.5 0.019148 3.8 0.011 0.001936 18

Adults 50-99 yrs 0.5 0.017495 3.5 0.011 0.002118 19

Females 13-49 yrs* 0.07 0.019721 28 0.011 0.001996 18

*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 assumption was made 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. 
Fluazinam Dietary Exposure and Risk Assessment DP Number: D397722

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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: D397722

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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: C:\Documents and Settings\ddotson\My Documents\DEEM FCID\Fluazinam\

 Fluazinam2012acute.R08

Date created/last modified: 07-14-2012/11:50:12

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

 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 

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 

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 

0302338500 3B Shallot, fresh leaves 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 0.013500 1.000 1.000 

0501071000 5A Cabbage, Chinese, napa 0.013500 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 

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 
Fluazinam Dietary Exposure and Risk Assessment DP Number: D397722

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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 

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 

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 

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 

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 

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 
Fluazinam Dietary Exposure and Risk Assessment DP Number: D397722

Page 12 of 17

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: D397722

Page 13 of 17

Attachment 2: Results of Acute Dietary Exposure Assessment

Residue file: Fluazinam2012acute.R08

Analysis Date: 07-14-2012/13:18:43

Residue file dated: 07-14-2012/13:14:55

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

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

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

Summary calculations--per capita:

 95th Percentile 99th Percentile 99.9th Percentile

Exposure % aPAD Exposure % aPAD Exposure % aPAD 

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

US Population: 0.026393 5.28 0.061603 12.32 0.149939 29.99 

All Infants: 0.083776 16.76 0.147293 29.46 0.211463 42.29 

Children 1-2: 0.106710 21.34 0.189491 37.90 0.308126 61.63 

Children 3-5: 0.064022 12.80 0.115100 23.02 0.175905 35.18 

Children 6-12: 0.031323 6.26 0.065217 13.04 0.118435 23.69 

Youth 13-19: 0.017332 3.47 0.029815 5.96 0.054124 10.82 

Adults 20-49: 0.019148 3.83 0.031090 6.22 0.066911 13.38 

Adults 50-99: 0.017495 3.50 0.027960 5.59 0.044332 8.87 

Female 13-49: 0.019721 28.17 0.031934 45.62 0.067067 95.81 

===============================================================================
Fluazinam Dietary Exposure and Risk Assessment DP Number: D397722

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: C:\Documents and Settings\ddotson\My Documents\ DEEMFCID\Fluazinam

\Fluazinam2012chronic.R08

Date created/last modified: 07-14-2012/13:13:47

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

 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 

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 

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 

0302338500 3B Shallot, fresh leaves 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 0.013500 1.000 1.000 

0501071000 5A Cabbage, Chinese, napa 0.013500 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 

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 
Fluazinam Dietary Exposure and Risk Assessment DP Number: D397722

Page 15 of 17

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 

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 

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 

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 

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 

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 
Fluazinam Dietary Exposure and Risk Assessment DP Number: D397722

Page 16 of 17

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 0.037800 1.000 1.000 

8602000000 86B Water, indirect, all sources 0.037800 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: D397722

Page 17 of 17

Attachment 4: Results of Chronic Dietary Exposure Assessment

Residue file name: C:\Documents and Settings\ddotson\My Documents\Deemfcid\

Fluazinam2011\Fluazinam2011chronic.R98

Residue file dated: 07-14-2012/13:13:47

Analysis Date: 07-14-2012/13:16:45

Residue file name: C:\Documents and Settings\ddotson\My Documents\DEEM FCID\Fluazinam

\Fluazinam2012chronic.R08

 

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

 Total exposure by population subgroup

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

 Total Exposure

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

 Population mg/kg Percent of 

 Subgroup body wt/day cPAD 

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

Total US Population 0.002145 19.5%

Hispanic 0.001795 16.3%

Non-Hisp-White 0.002318 21.1%

Non-Hisp-Black 0.001494 13.6%

Non-Hisp-Other 0.002299 20.9%

Nursing Infants 0.002550 23.2%

Non-Nursing Infants 0.005990 54.5%

Female 13+ PREG 0.001372 12.5%

Children 1-6 0.004298 39.1%

Children 7-12 0.001856 16.9%

Male 13-19 0.001150 10.5%

Female 13-19/NP 0.001192 10.8%

Male 20+ 0.001756 16.0%

Female 20+/NP 0.002268 20.6%

Seniors 55+ 0.002145 19.5%

All Infants 0.004928 44.8%

Female 13-50 0.002002 18.2%

Children 1-2 0.005635 51.2%

Children 3-5 0.003751 34.1%

Children 6-12 0.002031 18.5%

Youth 13-19 0.001171 10.6%

Adults 20-49 0.001936 17.6%

Adults 50-99 0.002118 19.3%

Female 13-49 0.001996 18.1%

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