**UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D.C. 20460** 
**OFFICE OF CHEMICAL SAFETY**  **AND POLLUTION PREVENTION** 
**MEMORANDUM Date:**  **9 /**  **7 /201**  **2 SUBJECT:**  **Fluazinam** Acute and Chronic Aggregate Dietary (Food and Drinking Water)

Exposure and Risk Assessments for the Section 3 Registration Action on Soy beans, the Melon Subgroup (9A), and the Pepper/Eggplant Subgroup (8
- 10 B) **PC Code:** 129098 **DP Barcode:** D 39 7722 **Decision No s**  **.:** 4 5910 7 **Registration No. :**  71512
- 1 **Petition:** 1E7959, 2F7977 **Regulatory Action:** Section 3 Registration **Risk Assessment Type:** Dietary **Case No.:** 7013 **T XR 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 Id eliz 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 soy beans, the melon subgrou p (9B) and the pepper/eggplant subgroup (8
- 10 B)
. The estimated drinking water concentrations (EDWCs) are based on a currentl y registered use on turf
. T he acute anal ys i s is based on tolerance
- level residues for all commodities and uses high
- end residue e stimates 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 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 95 th percentile of exposure are below HED’s level of concern for all population subgroups, including those comprised of infants an d 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 F emales 13
- 49, which uses 2 8 % 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 estimates for AM GT , 100% crop treated , and incorporates modeled EDWCs that account for both parent and transformation products
. Th e resulting exposure and risk estimates are considered to be c onservative. C hronic 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 high ly exposed population subgroup is Children 1
- 2 , which uses 51 % 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 of risk using a non - linear approach (i.e., RfD) will adequatel y 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 i s referre d to as the population
- adjusted dose (PAD). The PAD is equivalent to the point of departure ( e.g., POD, NOAEL, or LOAEL) divided b y the required uncertaint y or safet y factors.Fluazinam Dietary Exposure and Risk Assessment DP Number: D397722

Page 3 of 17 For acute and non
- cancer chronic exposures, HED is concerned when estimated die tary 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 J un 2000, we b 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 b y D . Dot son ( D 3 94960 , 2 / 7 /20 1 2 ). **II. Residue Information**  Fluazinam is currentl y 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, t he 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 by products of cattle, goats, horses, and sheep. The tol erances 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. Inthe crop field trials that were performed, AMGT was measured in some commoditi es but not in others. As a result, the residue levels that were used in the dietary

exposure assessments were determined in different way s. As the residue of concern in peanuts, bulb vegetables , and root and tuber vegetables is parent only , tolerance
- lev el residues were used for these commodities. For the commodities in the current tolerance petitions (soy beans, cantaloupe, and peppers), residues of parent fluazinam as well as residues of AMGT were measured in the field trial studies . For these commodit ies, the L OQ 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 f ield 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 dete rmined 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 levelsFluazinam Dietary Exposure and Risk Assessment DP Number: D397722

Page 4 of 17 used in the dietary

exposure assessments, see the last dietary exposure mem os that w ere written for fluazinam ( D276982, W. Cutchin, 8/22/2001 ; D340854, M. Dohert y, 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 0.0 5 ppm is being used for meat by products 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
. F ull listing s of the residue input s used in the anal ys es are included as Attachment s 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

Assessment s (ppm) Deriv ation of Residue Level Carrots 0.70 0.7 0 T olerance (parent only) Potatoes 0.02 0.02 T olerance (parent only) Ginseng 4.5 4.5 T olerance (parent only) Bulb Onions (Subgroup 3
- 07A) 0.20 0.20 T olerance (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 .0 1 tolerance x 1.35 Turnip Greens 0.01 0.0135 0 .0 1 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 .0 4 tolerance x 1.35 Dried Shelled Legumes, Subgroup 6
- C, except pea 0.02 0.027 0 .0 2 tolerance x 1.35 Soy bean 0.01 0.0 2 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 T olerance includes parent and AMGT Apples (Chronic Assessment) 2.0 0.215 A vg 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 ToleranceFluazinam Dietary Exposure and Risk Assessment DP Number: D397722

Page 5 of 17 Residue s in Fish Tolerances have not been established for fish commodities. F luazinam 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 pote ntial 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 anal yz ed 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 bas ed on the assumption that 100% of all commodities with fluazinam tolerances will be treated. **IV. Drinking Water Data**  The drinking water residue s used in the dietary risk assessment w ere provided by the Environmental Fate and Effects Division (EFED ; D 3 9 1 184 , J. Meléndez, 8 / 3 / 20 1 1 ) and incorporated directl y 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 EDWC s 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 f or the chronic assessment, a value of 37
. 8 ppb was used. This value also includes both parent and degradates. F or 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 B**  **ased on G**  **round**

**A pplication of**  **F luazinam**  **t o**  **T urf at a**  **S easonal**  **R ate of 8.4 lb a.i./A**  Source/Model Fluazinam Total Residues of Fluazinam 1 Acute/ppb Chronic/ppb Acute/ppb Chronic/ppb Surface Water/FIRST 217 2 1.47 226 2 37.8 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

Page 6 of 17 **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 I ntake Database DEEM
- FCID, Version 3.16, which incorporat es 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 day s. Foods “as consumed” (e.g., apple pie) are linked to EPA
- defined food commodities (e.g. apples, peeled fruit
- cooked; fresh or N/S; baked; or wheat flour
- cooked; fresh or N/S, baked) using publicl y available recipe translation files developed jointly by USDA/ARS and EPA. For chronic exposure assessment, consumption data are averaged for the entire 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 y ear old), children 1
- 2, childr en 3
- 5, children 6
- 12, y outh 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 food
form (e.g., orange or orange juice) on the food commodity residue l ist 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 for ms on 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, in dividual 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 deterministi c 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., onl y those who report ed 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 specificall y identified and noted in the risk assessment. **V I**  **. Toxicological Information**  The toxicity data show that the primary target organ for chronic exposure to fluazinam is the liver
. Li ver 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
. T he FQPA Safety F actor was reduced to 1 x for all population subgroups
. TheFluazinam Dietary Exposure and Risk Assessment DP Number: D397722

Page 7 of 17 CARC determined that quantification of risk u sing a non
- linear approach (i.e., RfD) will adequatel y 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 Hum**  **an Health Risk Assessments**  **Exposure/ Scenario**  **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 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 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 possibly increased incidence of fetal skeletal abnormalities. Chronic Dietary (All Populations) NOAEL= 1.1

mg/kg/day UF A= 10x

UF H =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. 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 d ose. **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, children 6
- 12, y outh 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 b oth the acute and chronic analy ses. 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 2 8 % 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 2 1 % 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 a s opposed to 0.07 mg/kg/day for Females 13
- 49)
.Fluazinam Dietary Exposure and Risk Assessment DP Number: D397722

Page 8 of 17 The chronic risk estimate for the general U.S. population is 20 % of the c PAD. The most highl y exposed population subgrou p is Children 1
- 2 , which uses 51 % of the cPAD. Finall y, c ancer risk is 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/kg/ day Exposure Estimate,

mg/kg/ day % a P AD c PAD, mg/kg/ day Exposure Estimate,

mg/kg/ day %

c P AD U.S. Population 0.5 0.0 2 6393 5. 3 0.011 0.00 2145 20 All infants 0.5 0.0 83776 1 7 0.011 0.00 4928 45 **Children 1 -**  **2 yrs** ***** 0.5 0. 10 6710 2 1 **0.011 0.00**  **5635 51**  Children 3
- 5 y

rs 0.5 0.0 6 4022 13 0.011 0.00 3751 3 4 Children 6
- 12 y

rs 0.5 0.0 31323 6.3 0.011 0.00 2031 18 Youth 13
- 19 y

rs 0.5 0.0 1 7332 3. 5 0.011 0.00 1171 11 Ad ults 20
- 49 y

rs 0.5 0.0 1 9148 3. 8 0.011 0.001 936 1 8 Ad ults 50
- 99 yrs 0.5 0.0 1 7495 3. 5 0.011 0.00 2118 1 9 **Fem ales 13**  **- 49 yrs**  ***** **0.07 0.0**  **1 9721**  **2 8**  0.011 0.001 996 1 8 * The subpopulation with the highest acute or chronic risk estimate **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 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 transformati on 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. T hese assumptions result in highl y conservative, health
- protective estimates of exposure and risk. Inthe 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. **I X**  **. Conclusions**  The exposure estimates generated b y 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. C ancer risk is also not of concern
.Fluazinam Dietary Exposure and Risk Assessment DP Number: D397722

Page 9 of 17 **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 AssessmentFluazinam Dietary Exposure and Risk Assessment DP Number: D397722

Page 10 of 17 Attachment 1: Acute Dietary Residue Input F ile for Fluazinam DEEM FCID Version 3.16 Acute NO A EL for general population including infants and 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 \D EEM FCID \Fluazinam \ Fluazinam 201 2a cute.R 0 8 Date created/last modi fied: 07
- 14
- 201 2 /1 1 : 50 : 1 2

----------------------------------------------------------------------------------- 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) 0.020 000 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 0103 299000 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 Brocco li 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 1.0 00 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 Cabb age, 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 .000Fluazinam Dietary Exposure and Risk Assessment DP Number: D397722

Page 11 of 17 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 1.00 0 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 6 C 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 Watermelo n, 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 Blueber ry 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 1.00 0 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 1.000Fluazinam 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 S heep, 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 1.000Fluazinam Dietary Exposure and Risk Assessment DP Number: D397722

Page 13 of 17 Attachment 2: Results of Acute Dietary Exposure Assessment Residue file: Fluazinam 201 2a cute.R 0 8 Analy sis Date: 07
- 14
- 2012/13:18:43 Residue file dated: 07
- 14
- 201 2 /1 3 : 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 % a PA D Exposure % a PA D E xposure % a PA D

---------- -------- ---------- -------- ---------- -------- U S 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 95.8 1

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

Page 14 of 17 Attachment 3 : Chronic Dietary Residue Input F ile for Fluazinam DEEM FCID Version 3 .16 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 \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, f lour - 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 1.00 0 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 Cabba ge, 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 S oybean, seed 0.020000 1.000 1.000 0600349000 6 Soybean, soy milk 0.020000 1.000 1.000Fluazinam 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, s eed 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 1.0 00 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 Wa termelon 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 1.00 0 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 1.000Fluazinam Dietary Exposure and Risk Assessment DP Number: D397722

Page 16 of 17 3200173000 32 Goat, liver 0.050000 1.000 1.000 3500340000 3 5 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 1.000Fluazinam Dietary Exposure and Risk Assessment DP Number: D397722

Page 17 of 17 Attachme nt 4: Results of Chronic Dietary Exposure Assessment Residue file name: C: \

Documents and Settings \ ddotson\ My Documents \Deemfcid\ Fluazinam 2011 \Fluazinam 2011 c hronic
. R98 Residue file dated: 07
- 14
- 2012/13:13:47 Analy sis 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%

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