Fluazinam Dietary Exposure and Risk Assessment DP Number: D374522

PC Code: 129098

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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C. 20460

OFFICE OF 

PREVENTION, PESTICIDES

AND TOXIC SUBSTANCES 

MEMORANDUM

Date: 3/15/2010

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

Exposure and Risk Assessments for the Section 3 Registration Action on Apples, 

Carrots, Head Lettuce, Leaf Lettuce, and the Bulb Onion Subgroup (3-07A)

PC Code: 129098 DP Barcodes: D374522

Decision No.: 404254 Registration No.: 71512-1

Petitions: 8E7506, 9E7570, and 9F7571 Regulatory Action: Section 3 Registration

Risk Assessment Type: NA Case No.: NA

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

MRID Nos.: NA 40 CFR: §180.574

 

FROM: Douglas Dotson, Ph.D., Chemist

Risk Assessment Branch II

Health Effects Division (7509P)

THROUGH: Toiya Goodlow, Chemist

Debra Rate, Ph.D., Biologist

Dietary Exposure Science Advisory Council

TO: Laura Nollen/Barbara Madden, RM Team 5, RIMUERB

John Bazuin/Tony Kish, PM Team 22, Fungicide 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 DEEM-FCIDTM, Version 2.03 

which uses food consumption data from the U.S. Department of Agriculture’s Continuing 

Surveys of Food Intakes by Individuals (CSFII) from 1994-1996 and 1998. The analyses were 
Fluazinam Dietary Exposure and Risk Assessment DP Number: D374522

PC Code: 129098

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conducted as part of a human health risk assessment for the requested uses of fluazinam on 

apples, carrots, head lettuce, leaf lettuce, and the Bulb onion subgroup (3-07A).

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 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 4.1% of the 

acute PAD (aPAD). The most highly exposed population subgroup is Females 13-49, which 

uses 20% 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. Again, the resulting exposure and risk estimates are 

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

all population subgroups. The risk estimate for the general U.S. population is 14% of the chronic 

PAD (cPAD). The most highly exposed population subgroup is All Infants (<1 year old), which 

uses 40% 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 using a linear 

low dose approach was not required and the cRfD is protective of cancer effects. As a result, a 

separate cancer dietary exposure analysis was not performed.

I. Introduction

Dietary risk assessment incorporates both exposure and toxicity of a given pesticide. For acute 

and chronic assessments, the risk is expressed as a percentage of a maximum acceptable dose 

(i.e., the dose which HED has concluded will result in no unreasonable adverse health effects). 

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

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

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

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

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

Exposure from Pesticides, A User’s Guide,” 21 Jun 2000, web link: 

http://www.epa.gov/fedrgstr/EPA-PEST/2000/July/Day-12/6061.pdf ; or see SOP 99.6 (20 Aug

1999).

The most recent dietary risk assessment for fluazinam was conducted by M. Doherty (Memo, 

D340854, 8/1/2007).
Fluazinam Dietary Exposure and Risk Assessment DP Number: D374522

PC Code: 129098

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II. Residue Information

Fluazinam is currently registered in the U.S. for use on ginseng, peanuts, potatoes, turnip greens, 

Crop Group 5 (Brassica leafy vegetables), Subgroup 6A (except pea), Subgroup 6B (except pea), 

Subgroup 6C (except pea), the Bushberry subgroup (13B), and other bushberries that are 

included in Subgroup 13-07B but not 13B. Tolerances range from 0.01 ppm for the Brassica

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

In addition, there is a tolerance of 3.0 ppm for residues in/on wine grapes (no U.S. registration). 

These tolerances are listed in 40 CFR 180.574. These commodities were all included in the most 

recent dietary exposure assessment that was performed for fluazinam (memo, D340854, M. 

Doherty, 8/1/2007).

The current tolerance petitions include apples, carrots, head lettuce, leaf lettuce, and the Bulb 

onion subgroup (3-07B). In addition, the 7.0 ppm tolerance for the Bushberry subgroup (13B) is 

being replaced by a 7.0 ppm tolerance for the updated Bushberry subgroup (13-07B). As a 

result, the individual tolerances for the various bushberry crops that were not a part of subgroup 

13-B are being revoked.

HED is recommending in favor of tolerances for lettuce and onions. However, because of major 

data deficiencies, HED is not recommending in favor of tolerances for apples and carrots. 

Apples and carrots are being included in the assessments, however, because HED is anticipating 

that the registrant will resolve the data deficiencies and pursue the tolerances for apples and 

carrots. As a result, the acute and chronic dietary exposure analyses include residue values for 

these commodities as well. Tolerances are currently in effect for potatoes and peanuts. These 

commodities have animal feed items associated with them (processed potato waste and peanut 

meal). Apples and carrots also have animal feed items associated with them (wet apple pomace 

and carrot culls). Because of these animal feed items, HED is including meat byproducts and fat

of cattle, goat, horse, and sheep in the acute and chronic dietary exposure analyses. 

The residue of concern for risk assessment in root and tuber vegetables and bulb vegetables is 

parent fluazinam. For all other plant commodities, the residues of concern in plants for risk 

assessment are fluazinam and its metabolite AMGT. Field trial data reflecting AMGT residues 

were provided for apples, but not for head or leaf lettuce. Data for AMGT are not needed for 

carrots and bulb onions because these crops are either root or bulb vegetables.

For carrots and the commodities of the Bulb onion subgroup (3-07B), the recommended 

tolerance was used in both the acute and chronic assessments. For head and leaf lettuce, 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 in the grape metabolism study. The 

values obtained using this ratio were used in both the acute and chronic assessments. In the 

apple field trials, both fluazinam and AMGT were measured. The fluazinam tolerance is 2.0 

ppm and the highest combined (fluazinam + AMGT) residue is 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 an explanation of the factors used for 
Fluazinam Dietary Exposure and Risk Assessment DP Number: D374522

PC Code: 129098

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previously registered plant commodities, see the last dietary exposure assessment that was 

performed for fluazinam (Memo, D340854, M. Doherty, 8/1/2007). 

In animal commodities, the residues of concern for risk assessment are parent fluazinam and its 

metabolites AMPA and DAPA. A residue value of 0.02 ppm is being used for meat byproducts 

and fat of cattle, goats, horses, and sheep (Memo, D360840, D. Dotson, x/x/2010). This value is 

a very conservative one that accounts for all residues of concern in meat byproducts and fat.

The assessments were based on DEEM 7.81 default processing factors for processed 

commodities. A full listing of the residue inputs used in the analyses is included as Attachments

1 and 3.

Table 1. Summary of New-Use Food Crop Residue Levels Used in the Acute and Chronic

 Dietary Exposure Analyses

Crop/Crop Group Tolerance Level

(ppm)

Residue Level for Dietary Exposure Assessment

(ppm)

Apples (Acute Assessment) 2.0 2.0 (tolerance)

Apples (Chronic Assessment) 2.0 0.215 (avg combined (fluazinam + AMGT) residue)

Carrots 0.70 0.7* (tolerance)

Bulb Onions (Subgroup 3-07A) 0.20 0.20* (tolerance)

Head Lettuce 0.02 0.027 (0.02 tolerance x 1.35)

Leaf Lettuce 2.0 2.7 (2.0 tolerance x 1.35)

*AMGT is not a significant residue in root and tuber crops or in bulb vegetables, so no correction is necessary for 

risk assessment

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 residue used in the dietary risk assessment was provided by the 

Environmental Fate and Effects Division (EFED; D360713, J. Meléndez, 2/24/2010) 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 and HYPA. The estimated acute and chronic drinking water concentrations (EDWC) are 

based on ground application of fluazinam to apples. The values are provided in Table 2, below. The 

groundwater value was generated using the Screening Concentration in Groundwater (SCIGROW) 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. For the acute 

assessment, a value of 117 ppb was used. This value includes both parent and degradates. For 
Fluazinam Dietary Exposure and Risk Assessment DP Number: D374522

PC Code: 129098

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the chronic assessment, a value of 19.8 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 I Estimated Drinking Water Concentrations 

Drinking Water Source (Model Used) USE (Rate Modeled) Maximum Estimated Drinking Water 

Concentration (EDWC; ppb)

Groundwater

(SCI-GROW) Total Residues of Fluazinam

(including parent)

Apples

(4.5 lb a.i./A/season)

Acute and Chronic 0.216

Surface Water

(FIRST) Total Residues of Fluazinam

(including parent)

Apples

(4.5 lb a.i./A/season)

Acute 117*

Chronic 19.8

* This value exceeds the solubility of fluazinam at pH 7 (71 ppb), but is lower than the solubility at pH 11.

V. DEEM-FCIDTM 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 DEEMFCIDTM,Version 2.03 which incorporates consumption data from USDA’s Continuing Surveys 

of Food Intakes by Individuals (CSFII), 1994-1996 and 1998. The 1994-96, 98 data are based on 

the reported consumption of more than 20,000 individuals over two non-consecutive survey

days. Foods “as consumed” (e.g., apple pie) are linked to EPA-defined food commodities (e.g. 

apples, peeled fruit - cooked; fresh or N/S; baked; or wheat flour - cooked; fresh or N/S, baked) 

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

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

within population subgroups, but for acute exposure assessment are retained as individual 

consumption events. Based on analysis of the 1994-96, 98 CSFII 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+ 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 
Fluazinam Dietary Exposure and Risk Assessment DP Number: D374522

PC Code: 129098

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

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

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

exposure and risk are reported for all tiers of analysis. However, for tiers 1 and 2, any significant 

differences in user vs. per capita exposure and risk are specifically identified and noted in the 

risk assessment.

VI. Toxicological Information

Adequate toxicological data have been submitted to permit assessment of fluazinam. The data 

show that the primary target organ for chronic exposure to fluazinam is the liver. Acute 

neurotoxicity was seen in rats and developmental toxicity was seen in rabbits. As a result, both 

acute and chronic dietary assessments are appropriate. The data also support reducing the FQPA 

Safety Factor to 1x. Based on the available information, a dietary assessment of cancer risk is 

not necessary. Detailed toxicological considerations can be found in the human health risk 

assessment for fluazinam (Memo, D371444, D. Dotson, 3/x/2010). The fluazinam doses and 

endpoints for dietary exposure assessments are summarized in Table 3.

Table 3. Toxicological Doses and Endpoints for Fluazinam for Use in Dietary 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

Total UF=100x

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

Total UF=100x

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 possible increased incidence 

of fetal skeletal abnormalities.

Chronic 

Dietary (All 

Populations)

NOAEL= 1.1 

mg/kg/day

UFA= 10x

UFH=10x

FQPA SF=1x

Total UF=100x

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.” The cRfD is protective of cancer effects.

Point of Departure (PoD) = A data point or an estimated point that is derived from observed dose-response data and 

used to mark the beginning of extrapolation to determine risk associated with lower environmentally relevant human 

exposures. NOAEL = no observed adverse effect level. LOAEL = lowest observed adverse effect level. UF = 

uncertainty factor. UFA = extrapolation from animal to human (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. N/A = not applicable.
Fluazinam Dietary Exposure and Risk Assessment DP Number: D374522

PC Code: 129098

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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+ 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 4.1% of the acute PAD (aPAD). The most highly 

exposed population subgroup is Females 13-49, which uses 20% of the aPAD. The chronic risk 

estimate for the general U.S. population is 14% of the chronic PAD (cPAD). The most highly 

exposed population subgroup is All Infants (<1 year old), which uses 40% of the cPAD.

The CARC determined that the cRfD is protective of cancer effects. As the %cPAD for the 

general population (14%) is less than 100%, cancer risk is also 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/day

Exposure Estimate, 

mg/day

% aPad cPAD, 

mg/day

Exposure Estimate, 

mg/day

% cPad

U.S. Population 0.5 0.020332 4.1 0.011 0.001530 14

All infants 0.5 0.086600 17 0.011 0.004411 40

Children 1-2 yrs 0.5 0.098940 20 0.011 0.004064 37

Children 3-5 yrs 0.5 0.063647 13 0.011 0.002789 25

Children 6-12 yrs 0.5 0.022625 4.5 0.011 0.001374 13

Youth 13-19 yrs 0.5 0.013076 2.6 0.011 0.000813 7.4

Adults 20-49 yrs 0.5 0.012952 2.6 0.011 0.001346 12

Adults 50+ yrs 0.5 0.012761 2.6 0.011 0.001488 14

Females 13-49 yrs 0.07 0.014124 20 0.011 0.001394 13

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 concerning 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. 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.
Fluazinam Dietary Exposure and Risk Assessment DP Number: D374522

PC Code: 129098

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IX. Conclusions

The exposure estimates generated by the dietary exposure model that was used are likely to be 

overestimates of actual dietary exposures that might occur. The aggregate (food + water) dietary

risk estimates are below HED’s level of concern for all population subgroups for both the acute 

and chronic exposure scenarios.

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

cc: D. Dotson
Fluazinam Dietary Exposure and Risk Assessment DP Number: D374522

PC Code: 129098

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Attachment 1: Acute Dietary Residue Input File for Fluazinam

DEEM FCID Version 2.03

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\Deemfcid\Fluazinam\

 FluazinamAcuteRev3.R98

Date created/last modified: 03-15-2010/13:48:15/8

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

 EPA Crop Def Res Adj.Factors Comment

 Code Grp Commodity Name (ppm) #1 #2 

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

01010780 1AB Carrot 0.700000 1.000 1.000 

01010781 1AB Carrot-babyfood 0.700000 1.000 1.000 

01010790 1AB Carrot, juice 0.700000 1.000 1.000 

01011680 1AB Ginseng, dried 4.500000 1.000 1.000 

01032960 1C Potato, chips 0.020000 1.000 1.000 

01032970 1C Potato, dry (granules/ flakes) 0.020000 6.500 1.000 

01032971 1C Potato, dry (granules/ flakes)-b 0.020000 6.500 1.000 

01032980 1C Potato, flour 0.020000 6.500 1.000 

01032981 1C Potato, flour-babyfood 0.020000 6.500 1.000 

01032990 1C Potato, tuber, w/peel 0.020000 1.000 1.000 

01032991 1C Potato, tuber, w/peel-babyfood 0.020000 1.000 1.000 

01033000 1C Potato, tuber, w/o peel 0.020000 1.000 1.000 

01033001 1C Potato, tuber, w/o peel-babyfood 0.020000 1.000 1.000 

03001640 3 Garlic 0.200000 1.000 1.000 

03001650 3 Garlic, dried 0.200000 1.000 1.000 

03001651 3 Garlic, dried-babyfood 0.200000 1.000 1.000 

03002370 3 Onion, dry bulb 0.200000 1.000 1.000 

03002371 3 Onion, dry bulb-babyfood 0.200000 1.000 1.000 

03002380 3 Onion, dry bulb, dried 0.200000 9.000 1.000 

03002381 3 Onion, dry bulb, dried-babyfood 0.200000 9.000 1.000 

03003380 3 Shallot 0.200000 1.000 1.000 

04012040 4A Lettuce, head 0.027000 1.000 1.000 

04012050 4A Lettuce, leaf 2.700000 1.000 1.000 

05010610 5A Broccoli 0.013500 1.000 1.000 

05010611 5A Broccoli-babyfood 0.013500 1.000 1.000 

05010620 5A Broccoli, Chinese 0.013500 1.000 1.000 

05010640 5A Brussels sprouts 0.013500 1.000 1.000 

05010690 5A Cabbage 0.013500 1.000 1.000 

05010710 5A Cabbage, Chinese, napa 0.013500 1.000 1.000 

05010720 5A Cabbage, Chinese, mustard 0.013500 1.000 1.000 

05010830 5A Cauliflower 0.013500 1.000 1.000 

05011960 5A Kohlrabi 0.013500 1.000 1.000 

05020630 5B Broccoli raab 0.013500 1.000 1.000 

05020700 5B Cabbage, Chinese, bok choy 0.013500 1.000 1.000 

05021170 5B Collards 0.013500 1.000 1.000 
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05021940 5B Kale 0.013500 1.000 1.000 

05022290 5B Mustard greens 0.013500 1.000 1.000 

05023180 5B Rape greens 0.013500 1.000 1.000 

05023890 5B Turnip, greens 0.013500 1.000 1.000 

06010430 6A Bean, snap, succulent 0.135000 1.000 1.000 

06010431 6A Bean, snap, succulent-babyfood 0.135000 1.000 1.000 

06012570 6A Pea, edible podded, succulent 0.135000 1.000 1.000 

06020310 6B Bean, broad, succulent 0.054000 1.000 1.000 

06020330 6B Bean, cowpea, succulent 0.054000 1.000 1.000 

06020370 6B Bean, lima, succulent 0.054000 1.000 1.000 

06022550 6B Pea, succulent 0.054000 1.000 1.000 

06022551 6B Pea, succulent-babyfood 0.054000 1.000 1.000 

06022590 6B Pea, pigeon, succulent 0.054000 1.000 1.000 

06030300 6C Bean, black, seed 0.027000 1.000 1.000 

06030320 6C Bean, broad, seed 0.027000 1.000 1.000 

06030340 6C Bean, cowpea, seed 0.027000 1.000 1.000 

06030350 6C Bean, great northern, seed 0.027000 1.000 1.000 

06030360 6C Bean, kidney, seed 0.027000 1.000 1.000 

06030380 6C Bean, lima, seed 0.027000 1.000 1.000 

06030390 6C Bean, mung, seed 0.027000 1.000 1.000 

06030400 6C Bean, navy, seed 0.027000 1.000 1.000 

06030410 6C Bean, pink, seed 0.027000 1.000 1.000 

06030420 6C Bean, pinto, seed 0.027000 1.000 1.000 

06030980 6C Chickpea, seed 0.027000 1.000 1.000 

06030981 6C Chickpea, seed-babyfood 0.027000 1.000 1.000 

06030990 6C Chickpea, flour 0.027000 1.000 1.000 

06031820 6C Guar, seed 0.027000 1.000 1.000 

06031821 6C Guar, seed-babyfood 0.027000 1.000 1.000 

06032030 6C Lentil, seed 0.027000 1.000 1.000 

06032560 6C Pea, dry 0.027000 1.000 1.000 

06032561 6C Pea, dry-babyfood 0.027000 1.000 1.000 

06032580 6C Pea, pigeon, seed 0.027000 1.000 1.000 

11000070 11 Apple, fruit with peel 2.000000 1.000 1.000 

11000080 11 Apple, peeled fruit 2.000000 1.000 1.000 

11000081 11 Apple, peeled fruit-babyfood 2.000000 1.000 1.000 

11000090 11 Apple, dried 2.000000 8.000 1.000 

11000091 11 Apple, dried-babyfood 2.000000 8.000 1.000 

11000100 11 Apple, juice 2.000000 1.300 1.000 

11000101 11 Apple, juice-babyfood 2.000000 1.300 1.000 

11000110 11 Apple, sauce 2.000000 1.000 1.000 

11000111 11 Apple, sauce-babyfood 2.000000 1.000 1.000 

13020570 13B Blueberry 7.800000 1.000 1.000 

13020571 13B Blueberry-babyfood 7.800000 1.000 1.000 

13021360 13B Currant 7.800000 1.000 1.000 

13021370 13B Currant, dried 7.800000 1.000 1.000 

13021490 13B Elderberry 7.800000 1.000 1.000 

13021740 13B Gooseberry 7.800000 1.000 1.000 

13021910 13B Huckleberry 7.800000 1.000 1.000 

21000460 M Beef, meat byproducts 0.050000 1.000 1.000 

21000461 M Beef, meat byproducts-babyfood 0.050000 1.000 1.000 

21000470 M Beef, fat 0.050000 1.000 1.000 

21000471 M Beef,fat-babyfood 0.050000 1.000 1.000 

21000480 M Beef, kidney 0.050000 1.000 1.000 

21000490 M Beef, liver 0.050000 1.000 1.000 

21000491 M Beef, liver-babyfood 0.050000 1.000 1.000 

23001700 M Goat, meat byproducts 0.050000 1.000 1.000 

23001710 M Goat, fat 0.050000 1.000 1.000 

23001720 M Goat, kidney 0.050000 1.000 1.000 

23001730 M Goat, liver 0.050000 1.000 1.000 

26003400 M Sheep, meat byproducts 0.050000 1.000 1.000 

26003410 M Sheep, fat 0.050000 1.000 1.000 

26003411 M Sheep, fat-babyfood 0.050000 1.000 1.000 

26003420 M Sheep, kidney 0.050000 1.000 1.000 
Fluazinam Dietary Exposure and Risk Assessment DP Number: D374522

PC Code: 129098

Page 11 of 15

26003430 M Sheep, liver 0.050000 1.000 1.000 

86010000 O Water, direct, all sources 0.117000 1.000 1.000 

86020000 O Water, indirect, all sources 0.117000 1.000 1.000 

95001790 O Grape, wine and sherry 3.000000 1.000 1.000 

95002630 O Peanut 0.020000 1.000 1.000 

95002640 O Peanut, butter 0.020000 1.890 1.000 

95002650 O Peanut, oil 0.020000 1.000 1.000 
Fluazinam Dietary Exposure and Risk Assessment DP Number: D374522

PC Code: 129098

Page 12 of 15

Attachment 2: Results of Acute Dietary Exposure Assessment

Residue file: FluazinamAcuteRev2.R98

Analysis Date: 03-15-2010/13:48:15 (13:50:15 for Females 13-49)

Residue file dated: 03-15-2010/13:48:15/8

Daily totals for food and food form consumption used.

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

Summary calculations (per capita):

 95th Percentile 99th Percentile 99.9th Percentile

 Exposure % aRfD Exposure % aRfD Exposure % aRfD 

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

U.S. Population:

 0.020332 4.07 0.056560 11.31 0.137350 27.47 

All infants:

 0.086600 17.32 0.138084 27.62 0.428363 85.67 

Children 1-2 yrs:

 0.098940 19.79 0.166177 33.24 0.312424 62.48 

Children 3-5 yrs:

 0.063647 12.73 0.114181 22.84 0.193539 38.71 

Children 6-12 yrs:

 0.022625 4.53 0.054452 10.89 0.085714 17.14 

Youth 13-19 yrs:

 0.013076 2.62 0.029793 5.96 0.052066 10.41 

Adults 20-49 yrs:

 0.012952 2.59 0.024926 4.99 0.042089 8.42 

Adults 50+ yrs:

 0.012761 2.55 0.022255 4.45 0.040379 8.08 

Females 13-49 yrs:

 0.014124 20.18 0.027763 39.66 0.051897 74.14
Fluazinam Dietary Exposure and Risk Assessment DP Number: D374522

PC Code: 129098

Page 13 of 15

Attachment 3: Chronic Dietary Residue Input File for Fluazinam

DEEM FCID Version 2.03

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\

 FluazinamChronicRev3.R98

Date created/last modified: 03-15-2010/13:41:58/8

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

 EPA Crop Def Res Adj.Factors Comment

 Code Grp Commodity Name (ppm) #1 #2 

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

01010780 1AB Carrot 0.700000 1.000 1.000 

01010781 1AB Carrot-babyfood 0.700000 1.000 1.000 

01010790 1AB Carrot, juice 0.700000 1.000 1.000 

01011680 1AB Ginseng, dried 4.500000 1.000 1.000 

01032960 1C Potato, chips 0.020000 1.000 1.000 

01032970 1C Potato, dry (granules/ flakes) 0.020000 6.500 1.000 

01032971 1C Potato, dry (granules/ flakes)-b 0.020000 6.500 1.000 

01032980 1C Potato, flour 0.020000 6.500 1.000 

01032981 1C Potato, flour-babyfood 0.020000 6.500 1.000 

01032990 1C Potato, tuber, w/peel 0.020000 1.000 1.000 

01032991 1C Potato, tuber, w/peel-babyfood 0.020000 1.000 1.000 

01033000 1C Potato, tuber, w/o peel 0.020000 1.000 1.000 

01033001 1C Potato, tuber, w/o peel-babyfood 0.020000 1.000 1.000 

03001640 3 Garlic 0.200000 1.000 1.000 

03001650 3 Garlic, dried 0.200000 1.000 1.000 

03001651 3 Garlic, dried-babyfood 0.200000 1.000 1.000 

03002370 3 Onion, dry bulb 0.200000 1.000 1.000 

03002371 3 Onion, dry bulb-babyfood 0.200000 1.000 1.000 

03002380 3 Onion, dry bulb, dried 0.200000 9.000 1.000 

03002381 3 Onion, dry bulb, dried-babyfood 0.200000 9.000 1.000 

03003380 3 Shallot 0.200000 1.000 1.000 

04012040 4A Lettuce, head 0.027000 1.000 1.000 

04012050 4A Lettuce, leaf 2.700000 1.000 1.000 

05010610 5A Broccoli 0.013500 1.000 1.000 

05010611 5A Broccoli-babyfood 0.013500 1.000 1.000 

05010620 5A Broccoli, Chinese 0.013500 1.000 1.000 

05010640 5A Brussels sprouts 0.013500 1.000 1.000 

05010690 5A Cabbage 0.013500 1.000 1.000 

05010710 5A Cabbage, Chinese, napa 0.013500 1.000 1.000 

05010720 5A Cabbage, Chinese, mustard 0.013500 1.000 1.000 

05010830 5A Cauliflower 0.013500 1.000 1.000 

05011960 5A Kohlrabi 0.013500 1.000 1.000 

05020630 5B Broccoli raab 0.013500 1.000 1.000 

05020700 5B Cabbage, Chinese, bok choy 0.013500 1.000 1.000 

05021170 5B Collards 0.013500 1.000 1.000 

05021940 5B Kale 0.013500 1.000 1.000 

05022290 5B Mustard greens 0.013500 1.000 1.000 

05023180 5B Rape greens 0.013500 1.000 1.000 

05023890 5B Turnip, greens 0.013500 1.000 1.000 

06010430 6A Bean, snap, succulent 0.135000 1.000 1.000 

06010431 6A Bean, snap, succulent-babyfood 0.135000 1.000 1.000 

06012570 6A Pea, edible podded, succulent 0.135000 1.000 1.000 
Fluazinam Dietary Exposure and Risk Assessment DP Number: D374522

PC Code: 129098

Page 14 of 15

06020310 6B Bean, broad, succulent 0.054000 1.000 1.000 

06020330 6B Bean, cowpea, succulent 0.054000 1.000 1.000 

06020370 6B Bean, lima, succulent 0.054000 1.000 1.000 

06022550 6B Pea, succulent 0.054000 1.000 1.000 

06022551 6B Pea, succulent-babyfood 0.054000 1.000 1.000 

06022590 6B Pea, pigeon, succulent 0.054000 1.000 1.000 

06030300 6C Bean, black, seed 0.027000 1.000 1.000 

06030320 6C Bean, broad, seed 0.027000 1.000 1.000 

06030340 6C Bean, cowpea, seed 0.027000 1.000 1.000 

06030350 6C Bean, great northern, seed 0.027000 1.000 1.000 

06030360 6C Bean, kidney, seed 0.027000 1.000 1.000 

06030380 6C Bean, lima, seed 0.027000 1.000 1.000 

06030390 6C Bean, mung, seed 0.027000 1.000 1.000 

06030400 6C Bean, navy, seed 0.027000 1.000 1.000 

06030410 6C Bean, pink, seed 0.027000 1.000 1.000 

06030420 6C Bean, pinto, seed 0.027000 1.000 1.000 

06030980 6C Chickpea, seed 0.027000 1.000 1.000 

06030981 6C Chickpea, seed-babyfood 0.027000 1.000 1.000 

06030990 6C Chickpea, flour 0.027000 1.000 1.000 

06031820 6C Guar, seed 0.027000 1.000 1.000 

06031821 6C Guar, seed-babyfood 0.027000 1.000 1.000 

06032030 6C Lentil, seed 0.027000 1.000 1.000 

06032560 6C Pea, dry 0.027000 1.000 1.000 

06032561 6C Pea, dry-babyfood 0.027000 1.000 1.000 

06032580 6C Pea, pigeon, seed 0.027000 1.000 1.000 

11000070 11 Apple, fruit with peel 0.215000 1.000 1.000 

11000080 11 Apple, peeled fruit 0.215000 1.000 1.000 

11000081 11 Apple, peeled fruit-babyfood 0.215000 1.000 1.000 

11000090 11 Apple, dried 0.215000 8.000 1.000 

11000091 11 Apple, dried-babyfood 0.215000 8.000 1.000 

11000100 11 Apple, juice 0.215000 1.300 1.000 

11000101 11 Apple, juice-babyfood 0.215000 1.300 1.000 

11000110 11 Apple, sauce 0.215000 1.000 1.000 

11000111 11 Apple, sauce-babyfood 0.215000 1.000 1.000 

13020570 13B Blueberry 7.800000 1.000 1.000 

13020571 13B Blueberry-babyfood 7.800000 1.000 1.000 

13021360 13B Currant 7.800000 1.000 1.000 

13021370 13B Currant, dried 7.800000 1.000 1.000 

13021490 13B Elderberry 7.800000 1.000 1.000 

13021740 13B Gooseberry 7.800000 1.000 1.000 

13021910 13B Huckleberry 7.800000 1.000 1.000 

21000460 M Beef, meat byproducts 0.050000 1.000 1.000 

21000461 M Beef, meat byproducts-babyfood 0.050000 1.000 1.000 

21000470 M Beef, fat 0.050000 1.000 1.000 

21000471 M Beef,fat-babyfood 0.050000 1.000 1.000 

21000480 M Beef, kidney 0.050000 1.000 1.000 

21000490 M Beef, liver 0.050000 1.000 1.000 

21000491 M Beef, liver-babyfood 0.050000 1.000 1.000 

23001700 M Goat, meat byproducts 0.050000 1.000 1.000 

23001710 M Goat, fat 0.050000 1.000 1.000 

23001720 M Goat, kidney 0.050000 1.000 1.000 

23001730 M Goat, liver 0.050000 1.000 1.000 

26003400 M Sheep, meat byproducts 0.050000 1.000 1.000 

26003410 M Sheep, fat 0.050000 1.000 1.000 

26003411 M Sheep, fat-babyfood 0.050000 1.000 1.000 

26003420 M Sheep, kidney 0.050000 1.000 1.000 

26003430 M Sheep, liver 0.050000 1.000 1.000 

86010000 O Water, direct, all sources 0.019800 1.000 1.000 

86020000 O Water, indirect, all sources 0.019800 1.000 1.000 

95001790 O Grape, wine and sherry 3.000000 1.000 1.000 

95002630 O Peanut 0.020000 1.000 1.000 

95002640 O Peanut, butter 0.020000 1.890 1.000 

95002650 O Peanut, oil 0.020000 1.000 1.000 
Fluazinam Dietary Exposure and Risk Assessment DP Number: D374522

PC Code: 129098

Page 15 of 15

Attachment 4: Results of Chronic Dietary Exposure Assessment

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

 FluazinamChronicRev3.R98

Residue file dated: 03-15-2010/13:41:58/8

Analysis Date 03-15-2010/13:51:29

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

 Total exposure by population subgroup

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

 Total Exposure

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

 Population mg/kg Percent of 

 Subgroup body wt/day Rfd 

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

U.S. Population (total) 0.001530 13.9%

U.S. Population (spring season) 0.001483 13.5%

U.S. Population (summer season) 0.001563 14.2%

U.S. Population (autumn season) 0.001553 14.1%

U.S. Population (winter season) 0.001518 13.8%

Northeast region 0.001699 15.4%

Midwest region 0.001413 12.8%

Southern region 0.001306 11.9%

Western region 0.001859 16.9%

Hispanics 0.001378 12.5%

Non-hispanic whites 0.001636 14.9%

Non-hispanic blacks 0.001048 9.5%

Non-hisp/non-white/non-black 0.001532 13.9%

All infants (< 1 year) 0.004411 40.1%

Nursing infants 0.002420 22.0%

Non-nursing infants 0.005167 47.0%

Children 1-6 yrs 0.003082 28.0%

Children 7-12 yrs 0.001261 11.5%

Females 13-19 (not preg or nursing) 0.000812 7.4%

Females 20+ (not preg or nursing) 0.001544 14.0%

Females 13-50 yrs 0.001415 12.9%

Females 13+ (preg/not nursing) 0.001169 10.6%

Females 13+ (nursing) 0.001183 10.8%

Males 13-19 yrs 0.000808 7.3%

Males 20+ yrs 0.001250 11.4%

Seniors 55+ 0.001512 13.7%

Children 1-2 yrs 0.004064 36.9%

Children 3-5 yrs 0.002789 25.4%

Children 6-12 yrs 0.001374 12.5%

Youth 13-19 yrs 0.000813 7.4%

Adults 20-49 yrs 0.001346 12.2%

Adults 50+ yrs 0.001488 13.5%

Females 13-49 yrs 0.001394 12.7%

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