Document ID: EPA-HQ-OPP-2009-0636-0023
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2011-01-26T05:00Z

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).

PC Code:  080818	DP Barcode: D376909

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)

  SEQ CHAPTER \h \r 1   SEQ CHAPTER \h \r 1 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)-fluoroethy
l)] 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

  SEQ CHAPTER \h \r 1  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 (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
HED-recommended 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.

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 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:   HYPERLINK
"http://www.epa.gov/oppefed1/models/water/" 
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 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.

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 food-form (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.  

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.    SEQ CHAPTER \h \r 1  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.  

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.   

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 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).  

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
 

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
 

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
 

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
 

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  

                                      

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%

Indaziflam                                              Dietary Exposure
Assessment                                       DP Barcode: D376909

PC Code: 080818		

	

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