### 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 / 1 5 /2010 SUBJECT: Fluazinam Acute and Chron ic 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 , 9 E 757 0 , and 9F7571 Regulatory Action: Section 3 Registration Risk Assessment Type: NA Case No.: NA T XR 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: Toiy a 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 use s food consumption data from the U.S. Department of Agriculture’s Continuing Survey s of Food Intakes by Individuals (CSFII) fr om 1994

- 1996 and 1998

. The anal ys es 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)

. T he acute anal ys i s is based on tolerance

- level residues for all commodities and uses high

- end residue estimates for the metabolite AM GT

. In addition, the acute assessment assume s 100% crop treated and incorporate s modeled estimat ed drinking water concentration s (EDWC s ) that account for both par ent 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 population

adjusted 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 subgr oup is F emales 13

- 49, which uses 2 0 % of the aPAD. The chronic anal ys is 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 estimate s for AM GT , 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 c onservative. C hronic 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 high ly exposed population subgroup is A ll Infant s (<1 year old), which uses 4 0 % of the cPAD

. Fluazinam is classified as having “suggestive evidence of carcinogenicit y, 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 resu lt, a separate cancer dietary

exposure analy sis 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 max imum acceptable dose (i.e., the dose which HED has concluded will result in no unreasonable adverse health effects). This dose i s referred to as the population

- adjusted dose (PAD). The PAD is equivalent to point of departure (POD, NOAEL , LOAEL, e.g.) div ided by the required uncertainty

or safet y factors. For acute and non

- cancer chronic exposures, HED is concerned when estimated dietary risk exceeds 100% of the PAD. References which discuss the acute and chronic risk assessments in more detail are avail able 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

- PE ST/2000/July /Day

- 12/6061.pdf ; or see SOP 99.6 (20 Aug 1999). The most recent dietary

risk assessment for fluazinam was conducted b y M. Dohert y ( Memo, D 340854, 8/1/2007 ).

### Fluazinam Dietary Exposure and Risk Assessment DP Number: D374522 PC Code: 129098

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### II. Residue Information Fluazinam is currentl y 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 b ut not 13B. T olerance s 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. Dohert y, 8/1/2007). The current tolerance petitions include apples, c arrots, head lettuce, leaf lettuce, and the Bulb onion subgroup (3

- 07B). Inaddition, the 7.0 ppm tolerance for the Bushberry subgroup (13B) is being replaced b y 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 toler ances 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 e xposure anal ys es 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 by products and fat of cattle, goat, horse, and sheep in the acute and chronic dietary exp osure analy ses. 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 the se 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 AMG T:fluazinam ratio in grapes in the grape metabolism study

. The values obtained using this ratio were used in both the acute and chronic assessments. Inthe 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 ( M emo, D340854, M. Doherty , 8/1/2007). In animal commodities, the residues of concern for risk assessment are parent fluazinam and it s metabolites AMPA and DAPA. A residue value of 0.0 2 ppm is being used for meat b yproducts 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 i n meat by products and fat. The assessments were based on DEEM 7. 81 default processing factors for processed commodities. A full listing of the residue input s used in the anal ys es is included as Attachment s 1 and 3

.
Table 1. Summary of N ew - U se F ood Cro p 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 0.2 15 (avg combined (fluazinam + AMGT) residue) Carrots 0.70 0.7 * (tolerance) Bulb Onions (Subgroup 3

- 07A) 0.20 0.2 0* (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 flu azinam tolerances will be treated.
IV. Drinking Water Data The drinking water residue used in the dietary risk assessment w as provided by the Environmental Fate and Effects Division (EFED ; D 360713 , J. Meléndez, 2 / 24 / 20 10 ) and incorporated directl y int o 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, D APA 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 i n 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. 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. F or more information a bout 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 ; p pb) Groundwater (SCI

- GROW) Total Residues of Fluazinam (including parent) Apples (4.5 lb a.i./A/season) Ac ute and Chronic 0. 216
Surface Water (FIRST) Total Residues of Fluazinam (includin g parent) Apples (4.5 lb a.i./A/season) Ac ute 117* Chronic 19

. 8 * This value exceeds the solubility of fluazinam at pH 7 (71 ppb), but is low er 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 DEEM

FCIDTM,Version 2.03 which incorporates consumption data from USDA’s Continuing Survey s of Food Intakes b y 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 day s. Foods “as consume d” (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 anal ys is of the 1994

- 96, 98 CSFII co nsumption 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 ye ar old), children 1

- 2, children 3

- 5, children 6

- 12, y outh 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 food

form (e.g., orange or orange juice) on the food commodity residue list is multiplied by the average dail y consumption estimate for that food/food form to produce a residue intake estimate. The resulting residue intake estimate for each food/food form is summed with the residue intake estimates for all other food/food forms o n the commodity residue list to arrive at the total average estimated exposure. Exposure is expressed in mg/kg bod y weight/day and as a percent of the cPAD. This procedure is performed for each population subgroup. For acute exposure assessments, indivi dual 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., onl y those who reported e ating 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 anal ysis. How ever, for tiers 1 and 2, an y significant differences in user vs. per capita exposure and risk are specificall y identified and noted in the risk assessment.
V I . Toxicological Information Adequate toxicological data have been submitted to permit assessm ent 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 ar e appropriate. The data also support reducin g the FQPA Safety F actor to 1 x . 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, D 371444 , 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/ Sce nario Point of

Departure Uncertainty/

FQPA Safety Factors RfD, PAD, Level of

Concern for Risk Assessment Study and Toxicological Effects
Ac ute Dietary (General population) NOAEL= 50

mg/kg/day UF A= 10x

UF H =10x FQPA SF=1x Total UF=100x Ac ute RfD =0.5

mg/kg/day aPAD = 0.5mg/kg/day Ac ute Neurotoxicity

- Rats.

LOAEL = 1000 mg/kg/day based on decreased motor activity and soft stools on day of dosing. Ac ute Dietary (Fem ales 13

- 49 years of age) NOAEL

(developmental) = 7 mg/kg/day UF A= 10x

UF H =10x FQPA SF=1x Tota l UF=100x Ac ute 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 possibl e increased incidence of fetal skeletal abnormalities. Chron ic Dietary (All Populations) NOAEL= 1.1

mg/kg/day UF A= 10x

UF H =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. Cance r (oral, dermal, inhalation) Classification: “Suggestive evidence of carcinogenicity, but not sufficient to asses s human

carcinogenic potential. ” The cRfD is protective of cancer effects. Point of Departure (P o D) = 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. N OAEL = no observed adverse effect level. LOAEL = lowest observed adverse effe ct level. UF = uncertainty factor. UF A = extrapolation from animal to human (interspecies). UF H = 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.

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### V I I. Results/Discussion As stated above, for acute and chronic assessments, HED is concerned when dietary risk exceeds 100% of the PAD. The DEEM

- FCIDTM anal ys es 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 y ear old), children 1

- 2, children 3

- 5, childr en 6

- 12, y outh 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 analy ses. The acute risk estimate for the general U.S. population is 4.1 % of the acute PAD (aPAD). The most highl y 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 highl y exposed population subgroup is All Infants (<1 ye ar 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 anal ys is) and 4 (chronic anal ys is).
Table 4 . Summary of Acute and Chronic Exposure and Risk Estimates for Fluazinam Population Subgroup Ac ute Assessment (95 th Percentile) Chronic Assessment

a PAD, mg/day Exposure Estimate,

mg/day % a Pad c PAD, mg/day Exposure Estimate,

mg/day % c Pad U.S. Population 0.5 0.0 203 32 4.1 0.011 0.00 1 5 30 14 All infants 0.5 0.0 86 600 17 0.011 0.004 4 11 40 Children 1

- 2 y

rs 0.5 0. 0 98 940 20 0.011 0.00 40 64 3 7 Children 3

- 5 y

rs 0 .5 0.0 636 47 13 0.011 0.00 2 7 89 2 5 Children 6

- 12 y

rs 0.5 0.0 2 2 625 4.5 0.011 0.00 13 74 1 3 Youth 13

- 19 y

rs 0.5 0.0 1 3076 2.6 0.011 0.000 8 13 7. 4 Adults 20

- 49 y

rs 0.5 0.0 12 9 52 2.6 0.011 0.001 3 4 6 12 Adults 50+ yrs 0.5 0.0 12 76 1 2.6 0.011 0.001 48 8 14 Fem ales 13 - 49 yrs 0.07 0.0 1 41 24 20 0.011 0.001 3 9 4 13


### VI I I. Characterization of Inputs/Outputs HED considers b oth the acute and chronic assessments to be very conservative . The acute assessment is based on tolerance

- level residues for all commodities , with wors t
- 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 p roducts. These same assumptions and inputs were used for the chronic assessment, except that an average field trial value was used for apples. T hese assumptions result in highly conservative, health

- protective estimates of exposure and risk.

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### I X . Con clusions The exposure estimates generat ed b y the dietary exposure model that was used are likel y to be overestimates of actual dietary exposures that m ight occur. T he aggregate (food + water) dietary risk estimates are below HED’s level of concern for al l population subgroups for both the acute and chronic exposure scenarios.
X. List of Attachments Attachment 1. A cute D ietary Residue Input File for F luazinam. Attachment 2. Results of Acute Dietary Exposure Assessment Attachment 3

. Chronic Dietary Residue Input F ile for Fluazinam Attachment 4

. Results of Chronic Dietary Exposure Assessment cc: D. Dot son

### Fluazinam Dietary Exposure and Risk Assessment DP Number: D374522 PC Code: 129098

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### Attachment 1: Acute Dietary Residue Input F ile for Fluazinam DEEM FCID Version 2.03 Acute NO A EL for general population including infants an d children : 5 0 mg/kg bw/day Acute PAD for general population including infants and children : 0 .5 mg/kg bw/day Acute NO A EL 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\ FluazinamAcute Rev 3 .R98 Date created/last modi fied: 0 3

- 15

- 2010/1 3 : 4 8 : 1 5 /8

----------------------------------------------------------------------------- EPA Crop Def Res Adj.Factors Comment Code Grp Commodity Name (ppm) #1 #2

-------- ---- ------------------------------- ---------- ------ ------ --- 01010780 1AB Carrot 0.700000 1.000 1.000 01 010781 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 6.50 0 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 0.2 0 0000 1.000 1.000 03001650 3 Garlic, dried 0. 20 0000 1.000 1.000 03001651 3 Garlic, drie d
- babyfood 0.20 0000 1.000 1.000 03002370 3 Onion, dry bulb 0.20 0000 1.000 1.000 03002371 3 Onion, dry bulb
- babyfood 0.20 0000 1.000 1.000 0300238 0 3 Onion, dry bulb, dried 0.20 0000 9 .000 1.000 03002381 3 Onion, dry bulb, dried
- babyfood 0.20 0000 9 .000 1.000 03003380 3 Shallot 0.20 0000 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, Ch inese, 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 0.01350 0 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

### Fluazinam Dietary Exposure and Risk Assessment DP Number: D374522 PC Code: 129098

Page 10 of 15 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 Bea n, 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 0603 0981 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. 0 00000 1.000 1.000 11000080 11 Apple, peeled fruit 2.0 00000 1.000 1.000 11000081 11 Apple, p eeled fruit
- babyfood 2.0 00000 1.000 1.000 11000090 11 Apple, dried 2.0 00000 8.000 1.000 11000091 11 Apple, dried
- babyfood 2.0 00000 8.000 1.000 11000100 11 Apple, juice 2.0 0 0000 1. 3 00 1.000 11000101 11 Apple, juice
- b abyfood 2.0 00000 1.3 00 1.000 11000110 11 Apple, sauce 2.0 00000 1.000 1.000 11000111 11 Apple, sauce - babyfood 2.0 00000 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 1.00 0 21000460 M Beef, meat byproducts 0.0 5 0000 1.000 1.000 21000461 M Beef, m eat byproducts
- babyfood 0.05 0000 1.000 1.000 21000470 M Beef, f at 0.05 0000 1.000 1.000 21000471 M Beef,fat
- ba by food 0.05 0000 1.000 1.000 21000480 M Beef, k idney 0.05 0000 1.000 1.000 21000490 M Beef, l iver 0.05 0000 1.000 1.000 21000491 M Beef, l iver
- babyfood 0.05 0000 1.000 1.000 23001700 M Goat, m eat byproducts 0.05 0000 1.000 1.000 23001710 M Goat, f at 0.05 0000 1.000 1.000 23001720 M Goat, k idney 0.05 0000 1.000 1.000 23001730 M Goat, l iver 0.05 0000 1.000 1.000 26003400 M Sheep, meat byproducts 0.0 5 0000 1.000 1.000 26003410 M Sheep, fat 0.05 0000 1.000 1.000 26003411 M Sheep, fat
- babyfood 0.05 0000 1.000 1.000 26003420 M Sheep, kidney 0.05 0000 1.000 1.000

### Fluazinam Dietary Exposure and Risk Assessment DP Number: D374522 PC Code: 129098

Page 11 of 15 26003430 M Sheep, liver 0.05 0000 1.000 1.000 86010000 O Water, direct, all sources 0.117000 1.000 1.000 8 6020000 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: FluazinamAcute Rev2 .R98 Analy sis Date: 0 3

- 15

- 2010/1 3 : 48 : 1 5 (1 3 : 5 0 : 15 for Females 13

- 49) Residue file dated: 0 3

- 15

- 2010/1 3 : 4 8 : 1 5 /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 2.6 2 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 y rs: 0.0141 24 20.1 8 0.0277 63 39.6 6 0.0518 97 74. 14

### Fluazinam Dietary Exposure and Risk Assessment DP Number: D374522 PC Code: 129098

Page 13 of 15 

### Attachment 3 : Chronic Dietary Residue Input F ile for Fluazinam DEEM FCID Version 2.03 Chronic NO A EL: 1.1 mg/kg bw/day Chronic PAD : 0

. 011 mg/kg bw/day Filename: C: \

Documents and Settings \ddotson\My Documents \Deemfcid\Fluazinam\ FluazinamChronic Rev 3 .R98 Date created/last modified: 0 3

- 15

- 2010/1 3 : 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 0.02 0000 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 0.20 0000 1.000 1.000 03001650 3 Garlic, dried 0.20 0000 1.000 1.000 03001651 3 Garlic, dried
- babyfood 0.20 0000 1.000 1.000 03002370 3 Onion, dry bulb 0.20 0000 1.000 1.000 03002371 3 Onion, dry bulb
- babyfood 0.20 0000 1.000 1.000 03002380 3 Onion, dry bulb, dried 0.20 0000 9.000 1.000 03002381 3 Onion, dry bulb, dried
- babyfood 0.20 0000 9.000 1.000 03003380 3 Shallot 0.20 0000 1.000 1.00 0 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
- baby food 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 0 5023890 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 1.0 00 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 060304 00 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
- b abyfood 0.027000 1.000 1.000 06032580 6C Pea, pigeon, seed 0.027000 1.000 1.000 11000070 11 Apple, f ruit with peel 0.215 000 1.000 1.000 11000080 11 Apple, p eeled fruit 0.215 0 00 1.000 1.000 11000081 11 Apple, peeled fruit
- babyfo od 0.215 000 1.000 1.000 11000090 11 Apple, d ried 0.215 000 8.000 1.000 11000091 11 Apple, d ried
- babyfood 0.215 000 8.000 1.000 11000100 11 Apple, j uice 0.215 000 1. 3 00 1.000 11000101 11 Apple, j uice
- babyfood 0.215 000 1.3 00 1.000 11000110 11 Apple, s auce 0.215 000 1.000 1.000 11000111 11 Apple, s auce - babyfood 0.215 000 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 0.0 5 0000 1.000 1.000 21000461 M Beef, m eat byproducts
- babyfood 0.05 0000 1.000 1.000 21000470 M Beef, f at 0.05 0000 1.000 1.000 21000471 M Beef,fa t - babyfood 0.05 0000 1.000 1.000 21000480 M Beef, k idney 0.05 0000 1.000 1.000 21000490 M Beef, l iver 0.05 0000 1.000 1.000 21000491 M Be ef, l iver
- babyfood 0.05 0000 1.000 1.000 23001700 M Goat, m eat byproducts 0.05 0000 1.000 1.000 23001710 M Goat, f at 0.05 0000 1.000 1.000 23001720 M Goat, k idney 0.05 0000 1.000 1.000 23001730 M Goat, liver 0.05 0000 1.000 1.000 26003400 M Sheep, meat byproducts 0.05 0000 1.000 1.000 26003410 M Sheep, fat 0.05 0000 1.000 1.000 260 03411 M Sheep, fat
- babyfood 0.05 0000 1.000 1.000 26003420 M Sheep, kidney 0.05 0000 1.000 1.000 26003430 M Sheep, liver 0.05 0000 1.000 1.000 86010000 O Water, direct, all s ources 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\ FluazinamChronic Rev3 .R98 Residue file dated: 0 3

- 15

- 2010/1 3 : 41 : 58 /8 Analy sis Date 0 3

- 15

- 2010/1 3 : 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 (a utumn season) 0.001553 14.1% U.S. Population (winter season) 0.001518 13.8% Northeast region 0.001699 15.4% Midwest region 0.00141 3 12.8% Southern region 0.001306 11.9% Western region 0.001859 16.9% Hispanics 0.001378 12.5% Non - hispan ic 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% Chi ldren 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%

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