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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C. 20460

OFFICE OF 

CHEMICAL SAFETY AND

POLLUTION PREVENTION

MEMORANDUM

DATE: July 28, 2010

SUBJECT: Indaziflam: 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).

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Decision No.: 416570 Registration No.: 432-RLNR

Petition No.: 9F7589, 9E7588 Regulatory Action: Section 3 Registration

Risk Assessment Type: Single Chemical 

Aggregate, Dietary

Case No.: NA

TXR No.: NA CAS No.: 730979-19-8

MRID No.: NA 40 CFR: §180.xxx (not yet established)

REVIEWER: Elizabeth Holman, Chemist

Michael Doherty, Ph.D., Senior Chemist

William T. Drew, Chemist

Risk Assessment Branch II (RAB2)

Health Effects Division (HED; 7509P)

THROUGH: Mohsen Sahafeyan, Chemist 

 Amelia Acierto, Chemist

Dietary Exposure Science Advisory Council

Health Effects Division (HED; 7509P)

and

Richard Loranger, Ph.D., Branch Senior Scientist

Risk Assessment Branch II (RAB2)

Health Effects Division (HED; 7509P)

TO: Bethany Benbow/James Tompkins (RM25)

Herbicide Branch

Registration Division (7505P)
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Executive Summary

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

using the Dietary Exposure Evaluation Model (DEEM-FCID, Version 2.03), which uses food 

consumption data from the U.S. Department of Agriculture (USDA’s) Continuing Surveys of 

Food Intakes by Individuals (CSFII) from 1994-1996 and 1998. The analysis was performed to 

support a Section 3 registration for use of indaziflam [1,3,5-triazine-2,4-diamine, N-[(1R,2S)-2,3-

dihydro-2,6-dimethyl-1H-inden-1-yl]-6-[(1S,1R)-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 analysis is based on tolerance-level residues and 100% crop treated assumptions. 

DEEM-FCID (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 general U.S. population has a risk estimate that is well below HED’s level of concern (i.e. 

100% of the acute population adjusted dose (aPAD)), utilizing <1% of the aPAD. The most 

highly exposed population subgroup is all infants <1 year old, which utilizes 3% of the aPAD. 

Chronic Dietary (Food and Drinking Water) Exposure Results and Characterization

The chronic analysis is based on tolerance-level residues and 100% crop treated assumptions. 

DEEM-FCID (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 general 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 infants <1 year old, which utilizes 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 classified indaziflam as 

“Not likely to be carcinogenic to humans.” Therefore, there is no concern for cancer risk and a 

separate cancer dietary exposure analysis was not performed. 

I. Introduction

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

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

exceeds 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 on 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).

This is the first food use and first dietary risk assessment conducted for indaziflam. 

II. Residue Information

Indaziflam 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 biosynthesis inhibitor and is active at rates of 50 to 100 g ai/ha. The 

primary metabolite of indaziflam is fluoroethyldiaminotriazine (FDAT), which has been 

identified as a residue of concern for risk assessment and tolerance enforcement purposes. 

The petitioner has proposed a new Section 3 use on pome fruits, stone fruits, citrus, tree nuts 

(including 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 of the HEDrecommended tolerances (which include consideration of FDAT residues). 

Table 1 – Summary of HED-Recommended Tolerances for Proposed New Uses of

 Indaziflam

Commodity Recommended Tolerance (ppm)

Fruit, citrus, Group 10 0.01

Fruit, 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.
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Processing Factors:

Conducted at 5X 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 commodity (RAC); therefore, 

processed samples were not analyzed and processing 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 analysis 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 LOQ at a 5X exaggerated rate, data for the processed commodity of citrus oil is 

required due to the extremely high potential concentration factor (1000X). Citrus oil was not 

analyzed during the originally submitted processing study. The petitioner has been made aware 

of this issue and provided data from a preliminary analysis 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 LOQ (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 analysis.

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 (4.3X). Thus, the empirical processing factor of 2.8X was used for raisins

and the default processing factor of 1.2X was used for grape juice. 

For sugarcane, samples from the processing study showed no quantifiable residues of indaziflam 

or FDAT following a 2X application rate, and the processed commodities of molasses and 

refined sugar were not analyzed. Typically, 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. Therefore, 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 and Effects Division (EFED) in the following memorandum: “Tier 2
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Drinking Water Exposure Assessment for the Section 3 New Chemical Registration of 

Indaziflam” (R.Baris, D356141/367447, 2/2/2010) and incorporated directly into this dietary

assessment. Water residues were incorporated in the DEEM-FCID 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 

Knowledgebase 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 lower 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-hydroxyethyl. 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 separate concentration estimates for 

FDAT plus dihydroamino triazine (ROI1; 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 ai/A) and thus protective of drinking water scenarios and 

populations. As noted above, HED has included the drinking water residue estimates for FDAT 

and ROI1 directly in the indaziflam assessment due to the available toxicity data indicating the 

neurotoxic 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 Model (PRZM, v3.12.2, 

5/12/2005) and the Exposure Analysis Modeling System (EXAMS, v2.98.4.6, 4/25/2005). These

simulation models are coupled to generate daily exposures and 1-in-10 year estimated drinking 

water concentrations of indaziflam residues that may 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 (SCI-GROW v2.3, Jul. 29, 

2003) regression model. These models and their descriptions 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 bSurface, ppb a Ground, ppb bSurface, 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 estimates 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 use rate of 0.134 lb ai/A for citrus.
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RAB2 has selected the most conservative estimate in order to be sufficiently protective of human 

health. The above residue estimates for FDAT and ROI1 were stoichiometrically converted to 

indaziflam equivalent and included directly in the indaziflam concentration estimates. Thus, 

following this stoichiometric conversion, the combined maximum surface water concentration in 

surface water was 84 ppb for the acute analysis and 26 ppb for the chronic analysis. These values 

were used in the acute and chronic dietary analyses, respectively. 

IV. DEEM-FCID Program and Consumption Information

Indaziflam acute and chronic dietary exposure assessments were conducted separately using the 

DEEM-FCID, Version 2.03, which incorporates consumption data from USDA’s CSFII, 1994-

1996 and 1998. The 1994-96, 98 data are based on the reported consumption of more than 

20,000 individuals over two non-consecutive survey days. Foods “as consumed” (e.g., apple pie) 

are linked to EPA-defined food commodities (e.g. apples, peeled fruit - cooked; fresh or N/S; 

baked; or wheat flour - cooked; fresh or N/S, baked) using publicly available recipe translation 

files developed jointly by USDA/ARS and EPA. For chronic exposure assessment, consumption 

data are averaged for the entire U.S. population and within population subgroups, but for acute 

exposure assessment are retained as individual consumption events. Based on analysis of the 

1994-96, 98 CSFII consumption data, which took into account dietary patterns and survey

respondents, HED concluded that it is most appropriate to report risk for the following 

population subgroups: the general U.S. population, all infants (<1 year old), children 1-2, 

children 3-5, children 6-12, youth 13-19, adults 20-49, females 13-49, and adults 50+ years old.

For chronic dietary exposure assessment, an estimate of the residue level in each food or foodform (e.g., orange or orange juice) on the food commodity residue list is multiplied by the 

average daily consumption estimate for that food/food form to produce a residue intake estimate. 

The resulting residue intake estimate for each food/food form is summed with the residue intake 

estimates for all other food/food forms on the commodity residue list to arrive at the total average 

estimated exposure. Exposure is expressed in mg/kg body weight/day and as a percent of the 

cPAD. This procedure is performed for each population subgroup.

For the acute exposure assessment, individual one-day food consumption data are used on an 

individual-by-individual basis. The reported consumption amounts of each food item can be 

multiplied by residue point estimate and summed to obtain a total daily pesticide exposure for a 

deterministic exposure, or “matched” in multiple random pairings with residue values and then 

summed in a probabilistic assessment. The resulting distribution of exposures is expressed as a 

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

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

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

exposure and risk are reported for all tiers of analysis. 
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V. Toxicological Information

The Health Effects Division (HED) has evaluated the toxicology database for indaziflam. 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-year dietary rat or mouse 

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. Based on the lack of evidence of carcinogenicity or genotoxicity, HED classified 

indaziflam as “Not likely to 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. 
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Table 3 - Summary of Toxicological Doses and 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

UFA= 10X

UFH= 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 

decreased motor and locomotor activity in 

females.

Chronic 

Dietary (All 

Populations)

NOAEL = 2 

mg/kg/day

UFA= 10X

UFH= 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 mouse 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 estimated point that is derived from observed dose-response data and 

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

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

uncertainty factor. UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity 

among members of the human population (intraspecies). FQPA SF = FQPA Safety Factor. PAD = population 

adjusted dose (a = acute, c = chronic). RfD = reference dose. 

VI. Results/Discussion

As stated above, for acute and chronic assessments, HED is concerned when dietary risk exceeds 

100% of the PAD. The DEEM-FCID analysis estimates the dietary exposure of the U.S. 

population and various population subgroups. The results reported in Table 4 are for the general 

U.S. Population, all infants (<1 year old), children 1-2, children 3-5, children 6-12, youth 13-19, 

females 13-49, adults 20-49, and adults 50+ years.

Results of Acute Dietary (Food and Drinking Water) Exposure Analysis

Table 4 lists the results of the acute dietary exposure analysis. The acute dietary risk estimates 

for the general U.S. population utilized <1% of the aPAD at the 95th percentile. The most highly

exposed population subgroup was all infants (<1 yr old), which utilized 3% of the aPAD at the 

95th percentile. All population exposures are well below HED’s level of concern. 
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Results of Chronic Dietary (Food and Drinking Water) Exposure Analysis

Table 4 lists the results of the chronic dietary exposure analysis. The chronic dietary risk 

estimates for the general U.S. population utilized 3% of the cPAD. The most highly exposed 

population subgroup was all infants (<1 yr old), which utilized 10% of the cPAD. All population 

exposures are well below HED’s level of concern. 

Table 4 - Summary of Dietary Exposure and Risk for Indaziflam1

Population Subgroup*

Acute Dietary

(95th percentile) Chronic Dietary Cancer

Dietary 

Exposure 

(mg/kg/day) % aPAD

Dietary 

Exposure

(mg/kg/day) % cPAD

Dietary 

Exposure

(mg/kg/day) Risk

General U.S. Population 0.004478 <1 0.000600 3 N/A N/A

All Infants (< 1 year old) 0.016674 3 0.001922 10

Children 1-2 years old 0.007148 1 0.001061 5

Children 3-5 years old 0.006459 1 0.000929 5

Children 6-12 years old 0.004447 <1 0.000606 3

Youth 13-19 years old 0.003648 <1 0.000438 2

Adults 20-49 years old 0.004104 <1 0.000542 3

Adults 50+ years old 0.003711 <1 0.000571 3

Females 13-49 years old 0.004117 <1 0.000543 3

1The value for the highest exposed population in the acute and chronic risk assessment is bolded. 

VII. Characterization of Inputs/Outputs

As the exposure estimates to all population subgroups are below HED’s level of concern, it was 

not necessary to make refinements to the acute or chronic dietary analysis. If it had been 

necessary to refine the analysis, 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 those comprised of infants and children. Based on the conservative nature of the acute 

and chronic dietary endpoints and the drinking water assessment, exposure and risk to indaziflam

are not expected to be underestimated. 

HED notes that EPA is in the process of formally changing the citrus and pome fruit crop group 
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definitions. These dietary analyses account for the revised crop group definitions. Therefore, 

new dietary exposure analyses will not be required if the registrant wishes to pursue registrations 

for the revised crop groups after they are implemented.

IX. List of Attachments

Attachment 1: Residue Input File for Acute Analysis

Attachment 2: Residue Input File for Chronic Analysis

Attachment 3: Results of Acute Dietary Exposure Analysis

Attachment 4: Results of Chronic Dietary Exposure Analysis

X. References

D356141/367447, 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 Subcommittee (ROCKS). 
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Attachment 1: Acute Analysis Indaziflam Residue Input File

Filename: F:\Indaziflam\Dietary\Indaziflam Acute 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: 07-14-2010/18:48:21/8 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, all 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 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-babyfood 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 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, 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 

11000101 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 1.000 
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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 0.010000 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 1.000 

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 

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 1.000 
Indaziflam Dietary Exposure Assessment DP Barcode: D376909

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: 07-14-2010/18:50:34/8 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 0.010000 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-babyfood 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 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, 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 

11000101 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 1.000 
Indaziflam Dietary Exposure Assessment DP Barcode: D376909

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 0.010000 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 1.000 

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 

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 1.000 
Indaziflam Dietary Exposure Assessment DP Barcode: D376909

PC Code: 080818

 Page 15 of 16

Attachment 3: Results of Indaziflam Acute Dietary Exposure Analysis

U.S. Environmental 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: 07-14-2010/18:56:22 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: ""

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

Summary 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 13474 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 4274 

 
Indaziflam Dietary Exposure Assessment DP Barcode: D376909

PC Code: 080818

 Page 16 of 16

Attachment 4: Results of Indaziflam 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 0.000683 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 infants (< 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%

Females 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%