Indaziflam Dietary Exposure Assessment DP Barcode: D 37 6909

PC Code: 080818

Page 1 of 16

UNITED STA

TES ENVIRONMENTA L PROTECTION A GENCY WASHINGTON, D.C. 20460
OFFICE OF CHEMICA L SA FETY A ND POLLUTION PREVENTION MEMORANDUM DATE: July 28 , 2010 SUBJECT: I ndaziflam : Acute and Chronic Aggregate Dietary Exposure (Food and Drinking Water) and Risk Assessment for the Section 3 Registration on Pome Fruits, Stone Fruits, Citrus, Tree Nuts (including Pistachios), Grapes, Olives, and Processed Cane Sugar (Import)
. PC Code: 080818 DP Barcode: D37690 9 Decision No.: 416570 Registration No. : 432
- RL NR Petition No.: 9F7589, 9E7588 Regulatory Action: Section 3 Registration Risk Assessment Type: Single Chemical Aggregate, Dietary Case No.: NA T XR No.: NA CAS No.: 730979
- 19
- 8 MRID No.: NA 40 CFR: § 180. xxx (not y et established) REVI EWER: Elizabeth Holman, Chemist

Michael Doherty , Ph.D., Senior Chemist William T. Drew, Chemist R isk Assessment Branch II (RAB2) Health Effects Division ( HED; 7509 P ) THROUGH: Mohsen Sahafey an, Chemist

Amelia Acierto, Chemist Dietary Exposure Science Advisory Council Health Effects Division ( HED; 7509P ) and Richard L oranger, Ph. D., Branch Senior Scientist Risk Assessment Branch I I (RAB2) Health Effects Division ( HED; 7509P ) TO: Bethany

Benbow/James Tompkins (RM25) Herbicide Branch Registration Division (7505P)Indaziflam Dietary Exposure Assessment DP Barcode: D 37 6909

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Page 2 of 16 Executive Summary A cute and chronic aggregate dietary risk assessment s (food and drinking water) w ere conducted using the Dietary

Expo sure Evaluation Model (DEEM
- FCI D, Version 2.03), which uses food consumption data from the U.S. Department of Agriculture ( USDA’s ) Continuing Survey s of Food Intakes by

Individuals (CSFI I) from 1994
- 1996 and 1998. The analy s i s w as performed to support a S ection 3 registration for use of indaziflam [ 1,3,5
- triazine
- 2,4
- diamine, N
- [(1 R ,2 S )
- 2,3
- dihy dro
- 2,6
- dimethyl
- 1 H
- inden
- 1
- yl ]
- 6
- [( 1 S ,1 R )
- fluoroethyl) ] on pome fruits, stone fruits, citrus, tree nuts (including pistachios), grapes, olives, and processed cane sugar (tolerance only , no U.S. registration)
. Acute Dietary

Exposure (Food and Drinking Water) Results and Characterization The acute analy sis is based on tolerance
- level residues and 100% crop treated assumptions. DEEM
- FCI D  ( Version 2.03 ) default pro cessing factors were used for all commodities, with the exception of the empirically derived raisin processing factor of 2
. 8 X
. The general U.S. population has a risk estimate that is well below HED’s level of concern (i.e. 100% of the acute population a djust ed dose (aPAD)), utilizing <1 % of the aPAD. The most highly exposed population subgroup is all i nfants <1 y ear old , which utilizes 3 % of the a PAD
. Chronic Dietary (Food and Drinking Water) Exposure Results and Characterization T he chronic analy si s is based on tolerance
- level residues and 100% crop treated a ssumption s . DEEM
- FCI D  ( Version 2.03 ) default processing factors were used for all commodities, with the exception of the empirically derived raisin processing factor of 2.8X
. The genera l U.S. population and all population subgroups have risk estimates that are well below HED’s level of concern (i.e., 100% of the chronic population adjusted dose (cPAD ) )
. The most highly exposed population subgroup is all i nfants <1 y ear old , which utiliz es 10 % of the cPAD. The general U.S. population utilizes 3 % of the cPAD. Cancer Dietary (Food and Drinking Water) Exposure Results and Characterization Based on the lack of evidence of carcinogenicity or genotoxicity , HED classifi ed indaziflam as “Not likely

to be carcinogenic to humans.” Therefore, there is no concern for cancer risk and a separate cancer dietary

exposure analy sis was not performed. I. Introduction Dietary risk assessment incorporates both exposure and toxici ty of a given pesticide. For acute and chronic assessments, the risk is expressed as a percentage of a maximum acceptable doseIndaziflam Dietary Exposure Assessment DP Barcode: D 37 6909

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Page 3 of 16 (i.e., the dose which HED has concluded will result in no unreasonable adverse health effects). This dose is referred to as the population adjusted dose (PAD). The PAD is equivalent to the point of departure (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 exc eeds 100% of the PAD. HED is generally concerned when estimated cancer risk exceeds one in one million. References which discuss the acute and chronic risk assessments in more detail are available on the EPA/pesticides web site: “Available Information o n Assessing Exposure from Pesticides, A User’s Guide,” 6/21/2000, web link: http://www.epa.gov/fedrgstr/EPA
- PEST/2000/July /Day
- 12/6061.pdf

; or see SOP 99.6 (8/20/99). Th is is the first food use and first dietary risk assessment conducted for i ndaziflam
. II. Residue Information In daziflam is a new alkylazine herbicide being developed for non
- selective pre
- emergent and early post - emergent control of annual grass and dicot species in trees, nuts, vines, and turf. This herbicide is a cellulose biosy nth esis inhibitor and is active at rates of 50 to 100 g ai/ha. The primary metabolite of indaziflam is fluoroethyl diaminotriazine (FDAT) , which has been identified as a residue of concern for risk assessment and tolerance enforcement purposes
. The petitio ner has proposed a new Section 3 use on pome fruits, stone fruits, citrus, tree nuts (inc luding pistachios), grapes , and olives , and has requested a tolerance without a U.S. registration for residues in/on processed cane sugar . See Table 1 for a summary o f the HED
recommended tolerances (which include consideration of FDAT residues)
. Table 1

– Summary of HED - Recommended Tolerances for Proposed New Use s of

Indaziflam Commodity Recommended Tolerance (ppm) Fruit, citrus, Group 10 0.01 Fr uit, pome, Group 11 0.01 Fruit, stone, Group 12 0.01 Nut, tree, Group 14 0.01 Pistachio 0.01 Almond, hulls 0.15 Grape 0.01 Olive 0.01 Sugarcane, sugar, refined 0.01 HED is making the conservative assumption of 100% crop treated.Indaziflam Dietary Exposure Assessment DP Barcode: D 37 6909

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Page 4 of 16 Processing Fa ctors: Conducted at 5 X the proposed maximum seasonal application rate, the submitted processing studies on pome fruit, stone fruit, citrus, and olives showed residues < limit of quantitation ( LOQ ) (0.01 ppm) in/on all samples of each raw agricultural comm odity ( RAC ) ; therefore, process ed samples were not analy zed and process ing factors could not be calculated. Although there was no evidence that residues of indaziflam concentrate in the processed commodities of these crops, default processing factors were included in the acute and chronic analy sis as per current HED policy

for screening
- level dietary exposure assessments
. Although citrus RACs from submitted field trials and a processing study have total residues below the L OQ at a 5X exaggerated rate , d ata for the processed commodity of citrus oil is required due to the extremely high potential concentration factor (1000X). Citrus oil was not analy zed during the originally

submitted processing study . The petitioner has been made aware of this issue and provided data from a preliminary analy sis of citrus oil. Although this interim report suggests that indaziflam residues are concentrated approximately 11.7X compared to those observed in citrus RACs, the total residues in citrus oil are still less than L OQ (0.01 ppm). Therefore, HED does not believe that a tolerance for citrus oil is required, as no finite residues would be expected even at exaggerated rates. Furthermore, since citrus oil does not appear as a commodity

in DEEM, the actual concentration factor is not needed for the exposure analy sis. Also conducted at 5X the proposed maximum season application rate, the grape processing study relied on residue estimates between the limit of detection ( LOD ) and LOQ in order to calculate processing factors . The calculated factor for grape juice (1.5X) is slightly greater than the theoretical maximum factor of 1.2X. The calculated factor for raisins (2.8X) is less than the theoretical maximum (4.3 X). Thus, the empirical processing factor of 2.8 X was used for raisins and the default processing factor of 1
. 2 X was used for grape juice
. For sugarcane, s amples from the processing study showed no quantifiable residues of indaziflam or FDAT following a 2X application rate, and the processed commodities of mola sses and refined sugar were not analy zed. Ty pically , HED requires that no residues of concern be found in a RAC following at least a 5X exaggerated application rate to make a finding that tolerances are not necessary

in the processed commodity . Based on information in the metabolism study , quantifiable residues of indaziflam or FDAT would not be expected in sugarcane even at a 5X treatment rate, with the highest observed total radioactive residue ( TRR ) of 0.005 ppm in the 2X metabolism study . Therefor e, HED does not believe that a processing factor is needed to assess residues of indaziflam and FDAT in refined sugar
. III. Drinking Water Data The drinking water residues used in the dietary risk assessment were provided by the Environmental Fate an d Effects Division (EFED) in the following memorandum: “ Tier 2Indaziflam Dietary Exposure Assessment DP Barcode: D 37 6909

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Page 5 of 16 Drinking Water Exposure Assessment for the Section 3 New Chemical Registration of In daziflam ” ( R.Baris, D 356141 / 367447 , 2/2/2010 ) and incorporated directly into this dietary assessment. Water residues were incorporated in the DEEM
- FCI D into the food categories “water, direct, all sources” and “water, indirect, all sources.” Based on a review of the available environmental fate data, the Residues of Concern Knowledge base Subcommittee ( ROCKS ) determined that the four major transformation products that maintain the dual ring structure of indaziflam should be included in the drinking water exposure assessment since they may be of toxicological concern (i.e., they are assumed to be of equal or lo wer toxicity

to the parent in the absence of toxicological data) (G.Kramer, D371659, 2/18/2010) . These transformation products include: triazine indanone, indaziflam
- carboxylic acid, indaziflam
- olefin, and indaziflam
- hy droxy ethyl. In order to account for residues of these transformation products, the Environmental Fate and Effects Division (EFED) calculated drinking water concentrations for total indaziflam residues which included indaziflam and similarly structured degradates. EFED also calculated separ ate concentration estimates for FDAT plus dihy droamino triazine (ROI 1; a degradate of FDAT). Drinking water concentrations were based on maximum seasonal application rates for citrus (0.134 lb ai/A), which is higher than turf application rates (0.094 lb a i/A) and thus protective of drinking water scenarios and populations. As noted above, HED has included the drinking water residue estimates for FDAT and ROI 1 directly

in the indaziflam assessment due to the available toxicity data indicating the neurotoxi c endpoints for indaziflam are protective of toxicity from these degradates. The drinking water concentrations used to estimate exposure via drinking water are included in Table 2
. Surface water estimates were calculated using the Pesticide Root Zone M odel ( PRZM, v3.12.2, 5/12/2005) and the Exposure Analy sis Modeling Sy stem (EXAMS, v2.98.4.6, 4/25/2005). These simulation models are coupled to generate daily exposures and 1
- in
- 10 y ear estimated drinking water concentrations of indaziflam residues that m ay occur in surface water bodies adjacent to application sites receiving indaziflam through runoff and spray drift. Groundwater estimates were calculated using the Screening Concentration in Ground Water (S CI
- GROW v2.3, Jul. 29, 2003) regression model
. T he se model s and their description s are available at the EPA internet site: http://www.epa.gov/oppefed1/models/water/
. Table 2 - Summary of Estimated Surface Water and Groundwater Concentrations for Indaziflam Exposure Duration Indaziflam FDAT + ROI1 Combined * Surface, ppb a Ground, ppb b Surface, ppb a Ground, ppb b Surface, ppb Ground, ppb Acute 48 1.6 19 1.1 84 3.7 Chronic (non
- cancer) 14 1.6 6 1.1 26 3.7 * Residue estimat es for FDAT and ROI1 have been converted to indaziflam equivalents (molecular weight ratio = 301÷157 = 1.92) and included directly in the indaziflam concentration estimates. a From the PRZM and EXAMS b From the SCI
- GROW model assuming a maximum seasonal u se rate of 0.134 lb ai/A for citrus.Indaziflam Dietary Exposure Assessment DP Barcode: D 37 6909

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Page 6 of 16 RAB2 has selected the most conservative estimate in order to be sufficiently protective of human health. The above residue estimates for FDAT and ROI 1 were sto i chiometrically converted to indaziflam equivalent and in cluded directly in the indaziflam concentration estimates. Thus, following this sto i chiometric conversion, the combined maximum surface water concentration in surface water was 84 ppb for the acute analy sis and 26 ppb for the chronic analy sis . These valu es were used in the acute and chronic dietary analy s e s , respectively
. IV. DEEM - FCID  Program and Consumption Information Indaziflam acute and chronic dietary exposure assessment s w ere conducted separately using the DEEM
- FCI D  , Version 2.03 , which incor porates consumption data from USDA’s CSFI I , 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 consumed” (e.g., apple pie) are linked to EPA
- defin ed 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, consumpti on 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 analy sis of the 1994
- 96, 98 CSFI I consumption data, which took into account diet ary 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, children 3
- 5, children 6
- 12, y outh 13
- 19, adults 20
- 49, females 13
- 49, and adults 50+ y ears 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 daily

consumpti on 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 the acute exposure assessment, individual one
- day food consumption data are use d on an individual
- by
- individual basis. The reported consumption amounts of each food item can be multiplied by

residue point estimate and summed to obtain a total daily pesticide exposure for a deterministic exposure, or “matched” in multiple random pair ings with residue values and then summed in a probabilistic assessment. The resulting distribution of exposures is expressed as a percentage of the aPAD on both a user (i.e., only those who reported eating relevant commodities/food forms) and a per capita (i.e., those who reported eating the relevant commodities as well as those who did not) basis. In accordance with HED policy , per capita exposure and risk are reported for all tiers of analy sis.Indaziflam Dietary Exposure Assessment DP Barcode: D 37 6909

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Page 7 of 16 V. Toxicological Information The Health Effects Divisi on (HED) has evaluated the toxicology database for i ndaziflam
. The RAB2 risk assessment team reviewed the toxicology data for indaziflam with regard to the acute and chronic reference doses and the toxicological endpoint selection. Table 3 below provides a summary of the doses and endpoints recommended for use in the dietary exposure assessments. There was no evidence of carcinogenicity observed in the two
- ye ar dietary rat or mouse carcinogenicity

bioassay s. Genotoxicity studies ( reverse gene mutation in bacteria, forward gene mutation in mammalian cells and in vitro and in vivo chromosomal aberration assay s) were negative. Based on the lack of evidence of carcinogenicity or genotoxicity , HED classified indaziflam as “Not likely t o be carcinogenic to humans.” HED recommends reduction of the FQPA safety factor to 1X. The toxicity database for indaziflam is complete, including the required studies that characterize potential susceptibility of infants and children. There was no evidence of increased quantitative or qualitative pre
- and/or postnatal susceptibility ; developmental effects in the rat were observed only at high doses in the presence of maternal/parental toxicity . Although indaziflam causes neurotoxicity , the effects are well characterized and served as the basis for endpoint selection. Therefore, this assessment is protective of potential neurotoxicity and other effects which occurred at higher doses.Indaziflam Dietary Exposure Assessment DP Barcode: D 37 6909

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Page 8 of 16 Table 3 - Summary of Toxicological Doses an d Endpoints for Indaziflam for Use in Dietary Human Health Risk Assessments Exposure/ Scenario Point of

Departure Uncertainty/FQPA

Safety Factors RfD, PAD,

Level of Concern for Risk Assessment Study and Toxicological Effects Acute Dietary (All Populations, including Infants and Children and Females 13
- 49 years of age) NOAEL =

50 mg/kg/day UF A = 10X

UF H = 10X FQPA SF= 1X Acute RfD =

0.5 mg/kg/day aPAD = 0.5 mg/kg/day Acute oral neurotoxicity in the rat

LOAEL = 100 mg/kg/day, based on decr eased motor and locomotor activity in females.

Chronic Dietary (All Populations) NOAEL = 2

mg/kg/day UF A = 10X

UF H = 10X FQPA SF= 1X Chronic RfD =

0.02 mg/kg/day cPAD = 0.02 mg/kg/day Chronic oral (dietary) toxicity in the dog

LOAEL = 6/7 mg/kg/day M/F, based on nerve fiber degenerative lesions in the brain, spinal cord and sciatic nerve. Cancer (oral, dermal, inhalation) Classification: “Not likely to be Carcinogenic to Humans , ” based on no evidence of

carcinogenicity in the two
- year dietary rat or m ouse carcinogenicity bioassays. Genotoxicity studies (reverse gene mutation in bacteria, forward gene mutation in mammalian cells and in vitro and in vivo chromosomal aberration assays) were negative. Point of Departure (POD) = A data point or an estim ated 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 observe d 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 adj usted dose (a = acute, c = chronic). RfD = reference dose.
VI. Results/Discussion As stated above, for acute and chronic assessments, HED is concerned when dietary risk exceeds 100% of the PAD. The DEEM
- FCI D  analy s i s estimate s 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+ y e ars. Results of Acute Dietary (Food and Drinking Water) Exposure Analy sis T able 4 lists the results of the acute dietary exposure analy sis. The acute dietary risk estimates for the general U.S. population utilized <1 % of the a PAD at the 95 th percentile
. The most highly exposed population subgroup was all infants (<1 y r old), which utilized 3% of the a PAD at the 95 th percentile . All population exposures are well below HED’s level of concern.Indaziflam Dietary Exposure Assessment DP Barcode: D 37 6909

PC Code: 080818

Page 9 of 16 Results of Chronic Dietary (Food and Drinking Water) Exposu re Analy sis Table 4 lists the results of the chronic dietary exposure analy sis
. The chronic dietary risk estimates for the general U.S. population utilized 3 % of the cPAD. The most highly exposed population subgroup was all infant s (<1 y r old), which ut ilized 10 % of the cPAD. All population exposures are well below HED’s level of concern.
Table 4 - Summary of Dietary Exposure and Risk for I ndaziflam 1

Population Subgroup* Acute Dietary (95 th percentile) Chronic Dietary Cancer Dietary Expos ure (mg/kg/day) % aPAD Dietary Exposure (mg/kg/day) % cPAD Dietary Exposure (mg/kg/day) Risk General U.S. Population 0.0044 78 <1 0.00060 0 3 N/A N/A All Infants (< 1 year old) 0.0166 74 3 0.00192 2 10 Children 1
- 2 years old 0.0071 4 8 1 0.0010 61 5 Children 3
- 5 years old 0.00645 9 1 0.0009 29 5 Children 6
- 12 years old 0.0044 47 <1 0.00060 6 3 Youth 13
- 19 years old 0.0036 48 <1 0.00043 8 2 Adults 20
- 49 years old 0. 00410 4 <1 0.00054 2 3 Adults 50+ years old 0. 00371 1 <1 0.00057 1 3 Females 13
- 49 years old 0. 0041 17 <1 0.00054 3 3 1 The value for the highest exposed population in the acute and chronic risk assessm ent is bolded. VII. Characterization of Inputs/Outputs As the exposure estimates to all population subgroups are below HED’s level o f concern , it was not necessary

to make refinements to the acute or chronic dietary analy sis. I f it had been necessary to refine the analy sis, field trial values could have been used in place of tolerance level residues. In addition, estimates of percent crop treated could have been used. VIII. Conclusions Based on very

conservative assumptions, the acute and chronic dietary risk estimates are well below HED’s level of concern for the general U.S. population and all population subgroups, including thos e comprised of infants and children. Based on the conservative nature of the acute and chronic dietary

endpoint s and the drinking water ass essment, exposure and risk to i ndaziflam are not expected to be underestimated. HED notes that EPA is in the proc ess of formally changing the citrus and pome fruit crop groupIndaziflam Dietary Exposure Assessment DP Barcode: D 37 6909

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Page 10 of 16 definitions. These dietary analy ses account for the revised crop group definitions. Therefore, new dietary

exposure analy ses will not be required if the registrant wishes to pursue registratio ns for the revised crop groups after they are implemented. I X. List of Attachments Attachment 1: Residue Input File for Acute Analy sis Attachment 2: Residue Input File for Chronic Analy sis Attachment 3: Results of Acute Dietary Exposure Analy sis Attachme nt 4 : Results of Chronic Dietary Exposure Analy sis X. References D 356141 / 367447 , R.Baris; February 2, 2010. Tier 2 Drinking Water Exposure Assessment for the Section 3 New Chemical Registration of Indaziflam
. D371659, G. Kramer; February 18, 2010. Indaziflam
. Report of the Residues of Concern Knowledgebase Subc ommittee (ROCKS)
.Indaziflam Dietary Exposure Assessment DP Barcode: D 37 6909

PC Code: 080818

Page 11 of 16 Attachment 1 : Acute Analysis Indaziflam Residue Input File Filename: F: \ Indaziflam \ Dietary \ Indaziflam Acute Food Uses + Water.R98 Chemical: Indaziflam RfD(Chronic): .0 2 mg/kg bw/day NOEL(Chronic): 2 mg/kg bw/day RfD(Acute): .5 mg/kg bw/day NOEL(Acute): 50 mg/kg bw/day Date created/last modified: 07

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- 2010/18:48:21/8 Program ver. 2.03

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

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

- 95001750 O Grape 0.010000 1.000 1.000 95001760 O Grape, juice 0.010000 1.200 1.000 95001761 O Grape, juice
- babyfood 0.010000 1.200 1.000 95001770 O Grape, leaves 0.010000 1.000 1.000 95001780 O Grape, raisin 0.010000 2.800 1.000 95001790 O Grape, wine and sherry 0.010000 1.000 1.000 95002350 O Olive 0.010000 1.000 1.000 95002360 O Olive, oil 0.010000 1.000 1.000 95003620 O Sugarcane, sugar 0.010000 1.000 1.000 95003621 O Sugarcane, sugar
- babyfood 0.010000 1.000 1.000 86010000 O Water, direct, a ll sources 0.084000 1.000 1.000 86020000 O Water, indirect, all sources 0.084000 1.000 1.000 10001060 10 Citrus citron 0.010000 1.000 1.000 10001070 10 Citrus hybrids 0.010000 1 .000 1.000 10001800 10 Grapefruit 0.010000 1.000 1.000 10001810 10 Grapefruit, juice 0.010000 2.100 1.000 10001970 10 Kumquat 0.010000 1.000 1.000 10001990 10 Lem on 0.010000 1.000 1.000 10002000 10 Lemon, juice 0.010000 2.000 1.000 10002001 10 Lemon, juice
- babyfood 0.010000 2.000 1.000 10002010 10 Lemon, peel 0.010000 1.000 1.000 10002060 10 Lime 0.010000 1.000 1.000 10002070 10 Lime, juice 0.010000 2.000 1.000 10002071 10 Lime, juice
- babyfood 0.010000 2.000 1.000 1000 2400 10 Orange 0.010000 1.000 1.000 10002410 10 Orange, juice 0.010000 1.800 1.000 10002411 10 Orange, juice
- babyfood 0.010000 1.800 1.000 10002420 10 Orange, peel 0.010000 1.000 1.000 10003070 10 Pummelo 0.010000 1.000 1.000 10003690 10 Tangerine 0.010000 1.000 1.000 10003700 10 Tangerine, juice 0.010000 2.300 1.000 11000070 11 Apple, fruit with peel 0.010000 1.000 1.000 11000080 11 Apple, peeled fruit 0.010000 1.000 1.000 11000081 11 Apple, peeled fruit
- babyfood 0.010000 1.000 1.000 11000090 11 Apple, d ried 0.010000 8.000 1.000 11000091 11 Apple, dried
- babyfood 0.010000 8.000 1.000 11000100 11 Apple, juice 0.010000 1.300 1.000 11000101 11 Apple, juice
- babyfood 0.01 0000 1.300 1.000 11000110 11 Apple, sauce 0.010000 1.000 1.000 11000111 11 Apple, sauce
- babyfood 0.010000 1.000 1.000 11001290 11 Crabapple 0.010000 1.000 1.000 11002100 11 Loquat 0.010000 1.000 1.000 11002660 11 Pear 0.010000 1.000 1.000 11002661 11 Pear
- babyfood 0.010000 1.000 1.000 11002670 11 Pear, dried 0.010000 6.250 1.000 11002680 11 Pear, juice 0.010000 1.000 1.000 11002681 11 Pear, juice
- babyfood 0.010000 1.000 1.000Indaziflam Dietary Exposure Assessment DP Barcode: D 37 6909

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Page 12 of 16 11003100 11 Quince 0.010000 1.000 1.00 0 12000120 12 Apricot 0.010000 1.000 1.000 12000121 12 Apricot
- babyfood 0.010000 1.000 1.000 12000130 12 Apricot, dried 0.010000 6.000 1.000 12000140 12 Apricot, juic e 0.010000 1.000 1.000 12000141 12 Apricot, juice
- babyfood 0.010000 1.000 1.000 12000900 12 Cherry 0.010000 1.000 1.000 12000901 12 Cherry
- babyfood 0.010000 1.000 1.000 12000910 12 Cherry, juice 0.010000 1.500 1.000 12000911 12 Cherry, juice
- babyfood 0.010000 1.500 1.000 12002300 12 Nectarine 0.010000 1.000 1.000 12002600 12 Peach 0.010000 1.000 1.000 12002601 12 Peach
- babyfood 0.010000 1.000 1.000 12002610 12 Peach, dried 0.010000 7.000 1.000 12002611 12 Peach, dried
- babyfood 0.010000 7.000 1.000 12002620 12 Peach, juice 0.010000 1.000 1.000 12002621 12 Peach, juice
- babyfood 0.010000 1.000 1.000 12002850 12 Plum 0.010000 1.000 1.000 1 2002851 12 Plum
- babyfood 0.010000 1.000 1.000 12002860 12 Plum, prune, fresh 0.010000 1.000 1.000 12002861 12 Plum, prune, fresh
- babyfood 0.010000 1.000 1.000 12002870 12 Plum, prune, dried 0.010000 5.000 1.000 12002871 12 Plum, prune, dried
- babyfood 0.010000 5.000 1.000 12002880 12 Plum, prune, juice 0.010000 1.400 1.000 12002881 12 Plum, prune, juice
- babyfood 0.010000 1.4 00 1.000 14000030 14 Almond 0.010000 1.000 1.000 14000031 14 Almond
- babyfood 0.010000 1.000 1.000 14000040 14 Almond, oil 0.010000 1.000 1.000 14000041 14 Almon d, oil
- babyfood 0.010000 1.000 1.000 14000590 14 Brazil nut 0.010000 1.000 1.000 14000680 14 Butternut 0.010000 1.000 1.000 14000810 14 Cashew 0 .010000 1.000 1.000 14000920 14 Chestnut 0.010000 1.000 1.000 14001550 14 Filbert 0.010000 1.000 1.000 14001560 14 Filbert, oil 0.010000 1.000 1.000 140018 50 14 Hickory nut 0.010000 1.000 1.000 14002130 14 Macadamia nut 0.010000 1.000 1.000 14002690 14 Pecan 0.010000 1.000 1.000 14002820 14 Pistachio 0.010000 1.000 1.000 14003910 14 Walnut 0.010000 1.000 1.000Indaziflam Dietary Exposure Assessment DP Barcode: D 37 6909

PC Code: 080818

Page 13 of 16 Attachment 2 : Chronic Analysis Indaziflam Residue Input File Filename: F: \ Indaziflam \ Dietary \ Indaziflam Chronic Food Uses + Water.R98 Chemical: Indaziflam RfD(Chronic): .02 mg/kg bw/day NOEL(Chronic): 2 mg/kg bw/day RfD(Acute): .5 mg/kg bw/day NOEL(Acute): 50 mg/kg bw/day Date created/last modified: 07

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- 2010/18:50:34/8 Program ver. 2.03

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

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

- 95001750 O Grape 0.010000 1.000 1.000 95001760 O Grape, juice 0.010000 1.200 1.000 95001761 O Grape, juice
- babyfood 0.010000 1.200 1 .000 95001770 O Grape, leaves 0.010000 1.000 1.000 95001780 O Grape, raisin 0.010000 2.800 1.000 95001790 O Grape, wine and sherry 0.010000 1.000 1.000 95002350 O Olive 0.010000 1.000 1.000 95002360 O Olive, oil 0.010000 1.000 1.000 95003620 O Sugarcane, sugar 0.010000 1.000 1.000 95003621 O Sugarcane, sugar
- babyfood 0.0100 00 1.000 1.000 86010000 O Water, direct, all sources 0.026000 1.000 1.000 86020000 O Water, indirect, all sources 0.026000 1.000 1.000 10001060 10 Citrus citron 0.010000 1.000 1.000 10001070 10 Citrus hybrids 0.010000 1.000 1.000 10001800 10 Grapefruit 0.010000 1.000 1.000 10001810 10 Grapefruit, juice 0.010000 2.100 1.000 10001970 10 Kumquat 0.010000 1.000 1.000 10001990 10 Lemon 0.010000 1.000 1.000 10002000 10 Lemon, juice 0.010000 2.000 1.000 10002001 10 Lemon, juice
- babyfood 0.010000 2.000 1.000 10002010 10 Lemon, peel 0.010000 1.000 1.000 10002060 10 Lime 0.010000 1.000 1.000 10002070 10 Lime, juice 0.010000 2.000 1.000 10002071 10 Lime, juice
- bab yfood 0.010000 2.000 1.000 10002400 10 Orange 0.010000 1.000 1.000 10002410 10 Orange, juice 0.010000 1.800 1.000 10002411 10 Orange, juice
- babyfood 0.010000 1.800 1.000 10002420 10 Orange, peel 0.010000 1.000 1.000 10003070 10 Pummelo 0.010000 1.000 1.000 10003690 10 Tangerine 0.010000 1.000 1.000 10003700 10 Ta ngerine, juice 0.010000 2.300 1.000 11000070 11 Apple, fruit with peel 0.010000 1.000 1.000 11000080 11 Apple, peeled fruit 0.010000 1.000 1.000 11000081 11 Apple, peeled fruit
- babyfood 0.010000 1.000 1.000 11000090 11 Apple, dried 0.010000 8.000 1.000 11000091 11 Apple, dried
- babyfood 0.010000 8.000 1.000 11000100 11 Apple, juice 0.010000 1.300 1.000 110 00101 11 Apple, juice
- babyfood 0.010000 1.300 1.000 11000110 11 Apple, sauce 0.010000 1.000 1.000 11000111 11 Apple, sauce
- babyfood 0.010000 1.000 1.000 11001290 11 Crabapple 0.010000 1.000 1.000 11002100 11 Loquat 0.010000 1.000 1.000 11002660 11 Pear 0.010000 1.000 1.000 11002661 11 Pear
- babyfood 0.010000 1.000 1.000 11002670 11 Pear, dried 0.010000 6.250 1.000 11002680 11 Pear, juice 0.010000 1.000 1.000 11002681 11 Pear, juice
- babyfood 0.010000 1.000 1.000Indaziflam Dietary Exposure Assessment DP Barcode: D 37 6909

PC Code: 080818

Page 14 of 16 11003100 11 Quince 0.010000 1.000 1.000 12000120 12 Apricot 0.010000 1.000 1.000 12000121 12 Apricot
- babyfood 0.010000 1.000 1.000 12000130 12 Apricot, dried 0.0 10000 6.000 1.000 12000140 12 Apricot, juice 0.010000 1.000 1.000 12000141 12 Apricot, juice
- babyfood 0.010000 1.000 1.000 12000900 12 Cherry 0.010000 1.000 1.000 12000901 12 Cherry
- babyfood 0.010000 1.000 1.000 12000910 12 Cherry, juice 0.010000 1.500 1.000 12000911 12 Cherry, juice
- babyfood 0.010000 1.500 1.000 12002300 12 Nectarine 0.010000 1.000 1.000 12002600 12 Peach 0.010000 1.000 1.000 12002601 12 Peach
- babyfood 0.010000 1.000 1.000 12002610 12 Peach, dried 0.010000 7.000 1.0 00 12002611 12 Peach, dried
- babyfood 0.010000 7.000 1.000 12002620 12 Peach, juice 0.010000 1.000 1.000 12002621 12 Peach, juice
- babyfood 0.010000 1.000 1.000 12002850 12 Plum 0.010000 1.000 1.000 12002851 12 Plum
- babyfood 0.010000 1.000 1.000 12002860 12 Plum, prune, fresh 0.010000 1.000 1.000 12002861 12 Plum, prune, fresh
- babyfood 0.010000 1.000 1.000 12002870 12 Plum, prune, dried 0.010000 5.000 1.000 12002871 12 Plum, prune, dried
- babyfood 0.010000 5.000 1.000 12002880 12 Plum, prune, juice 0.010000 1.400 1.000 12002881 12 Plum, prune, juice
- babyfood 0.010000 1.400 1.000 14000030 14 Almond 0.010000 1.000 1.000 14000031 14 Almond
- babyfood 0.010000 1.000 1.000 14000040 14 Almond, oil 0.010000 1.000 1.000 14000041 14 Almond, oil
- babyfood 0.010000 1.000 1.000 14000590 14 Brazil nut 0.010000 1.000 1.000 14000680 14 Butternut 0.010000 1.000 1.000 14000810 14 Cashew 0.010000 1.000 1.000 14000920 14 Chestnut 0.010000 1.000 1.000 14001550 14 Filbert 0.010000 1.000 1.000 14001560 14 Filbert, oil 0.010000 1.000 1.000 14001850 14 Hickory nut 0.010000 1.000 1.000 14002130 14 Macadamia nut 0.010000 1.000 1.000 14002690 14 Pecan 0.010000 1. 000 1.000 14002820 14 Pistachio 0.010000 1.000 1.000 14003910 14 Walnut 0.010000 1.000 1.000Indaziflam Dietary Exposure Assessment DP Barcode: D 37 6909

PC Code: 080818

Page 15 of 16 Attachment 3: Results of Indaziflam Acute Dietary Exposure Analysis U.S. En vironmental Protection Agency Ver. 2.02 DEEM - FCID ACUTE Analysis for INDAZIFLAM (1994
- 98 data) Residue file: Indaziflam Acute Food Uses + Water.R98 Adjustment factor #2 NOT used. Analysis Date: 07
- 1 4
- 2010/18:56:22 Residue file dated: 07

- 14
- 2010/18:48:21/8 NOEL (Acute) = 50.000000 mg/kg body

- wt/day Daily totals for food and foodform consumption used. Run Comment: ""

=============================================================================== S ummary calculations (per capita): 95th Percentile 99th Percentile 99.9th Percentile Exposure % aRfD MOE Exposure % aRfD MOE Exposure % aRfD MOE

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

--- U.S. Population: 0.004478 0.90 11166 0.008357 1.67 5983 0.016691 3.34 2995 All infants: 0.016674 3.33 2998 0.023770 4.75 2103 0.042158 8.43 1186 Children 1
- 2 yrs: 0.007148 1. 43 6995 0.012071 2.41 4142 0.017758 3.55 2815 Children 3
- 5 yrs: 0.006459 1.29 7741 0.010103 2.02 4948 0.016072 3.21 3111 Children 6
- 12 yrs: 0.004447 0.89 11243 0.007503 1.50 6663 0.010232 2.05 4886 Youth 13
- 19 yrs: 0.003648 0.73 13707 0.006069 1.21 8239 0.010775 2.15 4640 Adults 20
- 49 yrs: 0.004104 0.82 12183 0.006806 1.36 7346 0.012311 2.46 4061 Adults 50+ yrs: 0.003711 0.74 1347 4 0.005298 1.06 9437 0.008828 1.77 5663 Females 13
- 49 yrs: 0.004117 0.82 12144 0.006575 1.32 7604 0.011697 2.34 4274Indaziflam Dietary Exposure Assessment DP Barcode: D 37 6909

PC Code: 080818

Page 16 of 16 Attachment 4 : Results of I ndaziflam Chronic Dietary Exposure Analysis U.S. Environmental Protection Agency Ver. 2.00 DEEM - FCID Chronic analysis for INDAZIFLAM (1994
- 98 data) Residue file name: F: \ Indaziflam \ Dietary \ Indaziflam Chronic Food Uses + Water.R98 Adjustment factor #2 NOT used. Analysis Date 07
- 14
- 2010/18:54:02 Residue file dated: 07

- 14
- 2010/18:50:34/8 Reference dose (RfD, Chronic) = .02 mg/kg bw/day

================================== ============================================= Total exposure by population subgroup

------------------------------------------------------------------------------- Total Exposure

----------------------------------- Population mg/kg Percent of Subgroup body wt/day Rfd

----------------------------- --------- ------------- --------------- U.S. Population (total) 0.000600 3.0% U.S. Population (spring season) 0.000595 3.0% U.S. Population (summer season) 0.000639 3.2% U.S. Population (autumn season) 0.000582 2.9% U.S. Population (winter season) 0.000584 2.9% Northeast region 0.000564 2.8% Midwest region 0.000604 3.0% Southern region 0.000566 2.8% Western region 0.000681 3.4% Hispanics 0.00068 3 3.4% Non - hispanic whites 0.000584 2.9% Non - hispanic blacks 0.000575 2.9% Non - hisp/non

- white/non

- black 0.000733 3.7% All infant s (< 1 year) 0.001922 9.6% Nursing infants 0.000733 3.7% Non - nursing infants 0.002374 11.9% Children 1
- 6 yrs 0.000951 4.8% Children 7
- 12 yrs 0.000572 2.9% Females 13
- 19 (not preg or nursing) 0.000428 2.1% Females 20+ (not preg or nursing) 0.000579 2.9% Fem ales 13
- 50 yrs 0.000568 2.8% Females 13+ (preg/not nursing) 0.000579 2.9% Females 13+ (nursing) 0.000802 4.0% Males 13
- 19 yrs 0.000445 2.2% Males 20+ yrs 0.000521 2.6% Seniors 55+ 0.000571 2.9% Children 1
- 2 yrs 0.001061 5.3% Children 3
- 5 yrs 0.000929 4.6% Children 6
- 12 yrs 0.000606 3.0% Youth 13
- 19 yrs 0.000438 2.2% Adults 20
- 49 yrs 0.000542 2.7% Adults 50+ yrs 0.000571 2.9% Females 13
- 49 yrs 0.000543 2.7%