Document ID: EPA-HQ-OPP-2005-0491-0006
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2006-01-11T05:00Z

Page
1
of
12
UNITED
STATES
ENVIRONMENTAL
PROTECTION
AGENCY
WASHINGTON,
D.
C.
20460
OFFICE
OF
PREVENTION,
PESTICIDES,
AND
TOXIC
SUBSTANCES
MEMORANDUM
Date:
November
2,
2005
Subject:
Bitertanol.
Acute
and
Chronic
Dietary
Exposure
Assessments
for
the
Tolerance
Reassessment
Eligibility
Decision
(
TRED)
Document.

DP
Barcode:
D302880
PC
Code:
117801
40
CFR
§
:
180.457
Chemical
Class:
Azole
From:
Samuel
Ary,
Chemist
Reregistration
Branch
II
Health
Effects
Division
(
7509C)

Through:
Susan
L.
Stanton,
Environmental
Scientist
Sheila
Piper,
Chemist
Dietary
Exposure
Science
Advisory
Council
(
DESAC)
Health
Effects
Division
(
7509C)

Sherrie
L.
Kinard,
Chemist
William
Hazel,
Branch
Chief
Reregistration
Branch
II
Health
Effects
Division
(
7509C)

To:
Christina
Jarvis,
Risk
Assessor
Reregistration
Branch
II
Health
Effects
Division
(
7509C)

Rosanna
G.
Louie,
Chemical
Review
Manager
Reregistration
Branch
III
Special
Review
and
Reregistration
Division
(
7508C)
Bitertanol
Dietary
Exposure
Assessment
­
TRED
DP
Barcode:
302880
Page
2
of
12
Executive
Summary
Acute
and
chronic
dietary
(
food
only)
exposure
assessments
were
conducted
using
the
Dietary
Exposure
Evaluation
Model
software
with
the
Food
Commodity
Intake
Database
(
DEEMFCID
 
,
Version
2.03),
which
uses
food
consumption
data
from
the
USDA's
Continuing
Surveys
of
Food
Intakes
by
Individuals
(
CSFII)
from
1994­
1996
and
1998.
There
are
no
existing
registrations
for
the
use
of
bitertanol
in
the
United
States;
therefore,
the
acute
and
chronic
dietary
risk
assessments
were
conducted
to
support
the
tolerance
reassessment
eligibility
decision
for
bitertanol
use
on
imported
bananas.

Bitertanol,
$­([
1,1
'­
biphenyl]­
4­
yloxy)­"­(
1,1­
dimethylethyl)­
1H­
1,2,4­
triazole­
1­
ethanol,
is
a
fungicide
used
for
the
control
of
black
sigatoka,
a
fungal
disease
that
destroys
the
leaf
tissue
of
the
banana
plant.
Bitertanol
is
formulated
as
an
emulsifiable
concentrate
(
EC)
or
suspension
concentrate
(
SC)
and
may
be
applied
as
a
foliar
spray
by
airplane,
tractor
driven
equipment,
or
knapsack
sprayer.
The
active
ingredient
constitutes
30%
for
the
EC
formulation
and
50%
for
the
SC
formulation.
Applications
are
as
needed
and
based
on
the
speed
of
leaf
emergence
with
a
maximum
of
8
applications
during
the
development
period
of
a
fruit
bunch.
The
rate
per
application
is
0.13
lb
ai/
A
for
a
maximum
seasonal
application
rate
of
1.1
lb
ai/
A.
It
is
intended
for
use
on
bagged
bananas
only.

A
tolerance
has
been
established
under
40
CFR
§
180.457
for
the
residues
of
bitertanol
in/
on
bananas
at
0.20
ppm.
The
Codex
Alimentarius
Commission
(
Codex)
has
established
a
maximum
residue
limit
(
MRL)
for
bitertanol
residues
in/
on
bananas
at
0.5
mg/
kg.
Additionally,
the
Codex
MRL
for
bitertanol
is
expressed
in
terms
of
residues
of
bitertanol
only,
as
is
the
U.
S.
tolerance
expression.
It
is
the
Agency's
policy
to
harmonize
its
tolerances
with
the
levels
established
by
Codex
provided
that
the
Agency
has
sufficient
information
to
make
a
determination
that
the
Codex
MRLs
will
be
protective
of
the
health
of
the
U.
S.
public
and
meet
FFDCA
standards.
Therefore,
the
established
tolerance
should
be
reassessed
to
0.50
ppm
to
harmonize
with
Codex
as
the
acute
and
chronic
assessments
show
that
dietary
exposure
and
risk
are
not
of
concern.

Acute
and
Chronic
Dietary
Exposure
Results
and
Characterization
of
Input
Data
Conservative
acute
and
chronic
dietary
(
food
only)
assessments
were
performed
using
DEEMFCID
 
.
The
reassessed
tolerance
of
0.50
ppm,
DEEM
Version
7.81
default
processing
factor
of
3.9x
for
dried
bananas,
and
100%
crop
treated
were
used
to
conduct
this
Tier
1
(
unrefined)
assessment.

Acute
dietary
risk
estimates
are
provided
for
females
13­
49
years
old
only.
For
the
general
population
there
is
no
study
to
support
an
effect
from
a
single
dose.
This
assessment
concludes
that
for
the
supported
use
of
bitertanol
on
imported
bananas,
the
acute
dietary
risk
estimate
does
not
exceed
HED's
level
of
concern
(
less
than
100%
of
the
aPAD)
at
the
95th
exposure
percentile
for
females
13­
49
years
old
at
2%
of
the
aPAD.

Chronic
dietary
risk
estimates
are
provided
for
the
general
U.
S.
population
and
various
population
subgroups,
with
the
major
emphasis
placed
on
the
exposure
estimates
for
infants
and
children.
This
assessment
concludes
that
for
the
supported
use
of
bitertanol
on
imported
bananas,
the
chronic
dietary
risk
estimates
do
not
exceed
HED's
level
of
concern
(
less
than
100%
of
the
Bitertanol
Dietary
Exposure
Assessment
­
TRED
DP
Barcode:
302880
Page
3
of
12
O
N
N
N
OH
cPAD)
for
the
U.
S.
population
(
9%
of
the
cPAD)
and
all
population
subgroups,
with
the
highest
exposed
population
subgroup
being
children
1­
2
years
old
at
43%
of
the
cPAD.

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
the
Health
Effects
Division
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
Reference
Dose
(
RfD)
divided
by
the
special
FQPA
Safety
Factor.

For
acute
and
non­
cancer
chronic
exposures,
HED
is
concerned
when
estimated
dietary
risk
exceeds
100%
of
the
PAD.
References
which
discuss
the
acute
and
chronic
dietary
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/
1999).

II.
Residue
Information
The
nature
of
residues
in
plants
is
adequately
understood
based
on
acceptable
plant
metabolism
studies
in
apples
and
peanuts
conducted
with
bitertanol
labeled
in
the
biphenyl
ring
system
and
additional
studies
submitted
recently
in
apples,
cotton,
and
tomatoes
conducted
with
bitertanol
labeled
in
the
traizole
ring
system.
The
residues
identified
in
these
studies
consisted
primarily
of
the
parent
compound
with
traces
of
the
metabolites
bitertanol
ketone
and
4­
hydroxybiphenol.
Although
no
metabolism
studies
for
bananas
are
available,
the
Health
Effect
Division
(
HED)
has
concluded
that
the
nature
of
residues
in
bananas
is
likely
similar
to
that
in
apples,
cotton,
peanuts,
and
tomatoes.
Therefore,
HED
has
determined
that
the
bitertanol
residues
of
concern
in/
on
bananas
for
tolerance
expression
and
for
risk
assessment
are
bitertanol.
The
structure
of
bitertanol
is
presented
in
Table
1.

Bitertanol
is
not
intended
for
application
to
livestock
exported
to
the
U.
S.
In
addition,
there
are
no
feedstuffs
associated
with
bananas.
Therefore,
there
are
no
livestock
commodities
to
consider
in
this
assessment.

An
aggregate
(
food
and
water)
dietary
risk
assessment
is
not
required,
as
there
is
no
exposure
to
residues
of
bitertanol
through
drinking
water.

Table
1.
Chemical
Name
and
Structure
of
Bitertanol.

Chemical
Name
Structure
$­([
1,1
'­
biphenyl]­
4­
yloxy)­"­(
1,1­
dimethylethyl)­
1H­
1,2,4­
triazole­
1­
ethanol
Bitertanol
Dietary
Exposure
Assessment
­
TRED
DP
Barcode:
302880
Page
4
of
12
A
summary
of
the
bitertanol
tolerance
reassessment
and
recommended
modifications
in
commodity
definitions
is
presented
in
Table
2
(
S.
Ary,
D302882,
11/
2/
2005).

Table
2.
Tolerance
Reassessment
Summary
for
Bitertanol.

Commodity
Current
Tolerance,
ppm
Reassessed
Tolerance,
ppm
Comment
[
Correct
Commodity
Definition]

Tolerances
Established
Under
40
CFR
§
180.457(
a)

Banana
(
whole)
1
0.2
0.5
[
banana]

1.
40
CFR
§
180.457(
a)
states
that
there
are
no
U.
S.
registrations
as
of
April
1,
1992.

Residue
Data
used
for
Acute
and
Chronic
Dietary
Assessments
The
acute
and
chronic
dietary
exposure
assessments
incorporated
the
reassessed
tolerance
level
residue
of
0.50
ppm
for
bananas,
a
DEEM
Version
7.81
default
processing
factor
of
3.9x
for
dried
bananas,
and
100%
crop
treated.

Processing
Factors
A
DEEM
Version
7.81
default
processing
factor
of
3.9x
for
dried
bananas
was
used
to
conduct
the
acute
and
chronic
assessments.

Usage
Information
No
usage
data
is
available
for
bitertanol,
so
100%
crop
treated
was
assumed
for
bananas.

III.
DEEM­
FCID
 
Program
and
Consumption
Information
Bitertanol
acute
and
chronic
dietary
exposure
assessments
were
conducted
using
the
Dietary
Exposure
Evaluation
Model
software
with
the
Food
Commodity
Intake
Database
(
DEEMFCID
 
,
Version
2.03),
which
incorporates
consumption
data
from
USDA's
Continuing
Surveys
of
Food
Intakes
by
Individuals
(
CSFII),
1994­
1996
and
1998.
The
1994­
96,
98
data
are
based
on
the
reported
consumption
of
more
than
20,000
individuals
over
two
non­
consecutive
survey
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,
the
HED
concluded
that
it
is
most
appropriate
to
report
risk
for
the
following
population
subgroups:
the
general
U.
S.
population,
all
infants
(
less
than
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
Bitertanol
Dietary
Exposure
Assessment
­
TRED
DP
Barcode:
302880
Page
5
of
12
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
acute
exposure
assessments,
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
a
residue
point
estimate
and
summed
to
obtain
a
total
daily
pesticide
exposure
for
a
deterministic
exposure
assessment,
or
"
matched"
in
multiple
random
pairings
with
residue
values
and
then
summed
in
a
probabilistic
assessment.
The
resulting
distribution
of
exposures
is
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.
However,
for
tiers
1
and
2,
any
significant
differences
in
user
vs.
per
capita
exposure
and
risk
are
specifically
identified
and
noted
in
the
risk
assessment.

IV.
Toxicological
Information
A
summary
of
the
toxicological
doses
and
endpoints
selected
for
the
dietary
exposure
assessments
is
provided
in
Table
3.

Table
3.
Summary
of
Toxicological
Doses
and
Endpoints
for
Bitertanol.
1,2
Exposure
Scenario
Dose
Used
in
Risk
Assessment,
UF
Special
FQPA
SF*
and
Level
of
Concern
for
Risk
Assessment
Study
and
Toxicological
Effects
Acute
Dietary
(
Females
13­
49
years
of
age)
NOAEL
=
50
mg/
kg/
day
UF
=
1000
Acute
RfD
=
0.05
mg/
kg/
day
FQPA
SF
=
1X
aPAD
=
acute
RfD
FQPA
SF
=
0.05
mg/
kg/
day
Developmental
Toxicity
in
rabbits
MRID
40490801
Maternal;
LOAEL
=
150
mg/
kg/
day
based
on
decreased
body
weight
gain
and
food
consumption.
Developmental;
LOAEL
=
150
mg/
kg/
day
based
on
increased
potimplantation
loss,
decreased
fetal
weight,
and
reduced
ossification.

Acute
Dietary
(
General
population
No
endpoint
from
a
single
dose
was
seen
in
an
appropriate
study.

Chronic
Dietary
(
All
populations)
NOAEL=
2.11
mg/
kg/
day
UF
=
1000
Chronic
RfD
=
0.00211
mg/
kg/
day
FQPA
SF
=
1X
cPAD
=
chronic
RfD
FQPA
SF
=
0.00211
mg/
kg/
day
Chronic/
dog
[
MRID
00157466
&
00157465]
LOAEL
=
8.18
mg/
kg/
day
based
on
based
on
adrenal
vacuolation..

Cancer
(
oral,
dermal)
"
E,"
Unlikely
human
carcinogen.
No
dose
related
tumors
in
the
rat
or
mouse.

1.
Bitertanol.
HED
Chapter
of
the
Tolerance
Reassessment
Eligibility
Decision
Document
(
TRED).
PC
Code:
Bitertanol
Dietary
Exposure
Assessment
­
TRED
DP
Barcode:
302880
Page
6
of
12
117801,
Decision
No.:
343558,
DP
Barcode:
D302877.
2.
UF
=
uncertainty
factor,
FQPA
SF
=
Special
FQPA
safety
factor,
NOAEL
=
no
observed
adverse
effect
level,
LOAEL
=
lowest
observed
adverse
effect
level,
PAD
=
population
adjusted
dose
(
a
=
acute,
c
=
chronic)
RfD
=
reference
dose.

V.
Results/
Discussion
As
stated
above,
for
acute
and
chronic
assessments,
HED
is
concerned
when
dietary
risk
exceeds
100%
of
the
PAD.
The
DEEM­
FCID
 
analyses
estimate
the
dietary
exposure
of
the
U.
S.
population
and
various
population
subgroups.
The
acute
dietary
exposure
analysis
results
reported
in
Table
4
are
for
females
13­
49
years
old.
The
chronic
dietary
exposure
analysis
results
reported
in
Table
5
are
for
the
general
U.
S.
population,
all
infants
(
less
than
1
year
old),
children
1­
2,
children
3­
5,
children
6­
12,
youth
13­
19,
adults
20­
49,
adults
50+
years,
and
females
13­
49
year
old.

Results
of
Acute
Dietary
Exposure
Analysis
Acute
dietary
risk
estimates
are
provided
for
females
13­
49
years
old
only.
For
the
general
population
there
is
no
study
to
support
an
effect
from
a
single
dose.
This
assessment
concludes
that
for
the
supported
use
of
bitertanol
on
imported
bananas,
the
acute
dietary
risk
estimate
does
not
exceed
HED's
level
of
concern
(
less
than
100%
of
the
aPAD)
at
the
95th
exposure
percentile
for
females
13­
49
years
old
at
2%
of
the
aPAD.
The
results
of
the
acute
dietary
exposure
analysis
at
the
95th,
99th,
and
99.9th
percentiles
of
exposure
are
reported
in
Table
4.
The
results
of
the
acute
dietary
exposure
analysis
at
the
95th
percentile
are
reported
in
Table
5
along
with
chronic
dietary
exposure
analyses
for
easy
comparison.

Table
4.
Results
of
Acute
Dietary
Exposure
Analysis
for
Bitertanol
Using
DEEM­
FCID.

Population
Subgroup
aPAD
(
mg/
kg/
day)
95th
Percentile
99th
Percentile
99.9th
Percentile
Exposure
(
mg/
kg/
day)
%
aPAD*
Exposure
(
mg/
kg/
day)
%
aPAD*
Exposure
(
mg/
kg/
day)
%
aPAD*

Females
13­
49
year
old
0.050
0.000964
2
0.001283
3
0.002168
4
Results
of
Chronic
Dietary
Exposure
Analysis
This
assessment
concludes
that
for
the
supported
use
of
bitertanol
on
imported
bananas,
the
chronic
dietary
risk
estimates
do
not
exceed
HED's
level
of
concern
(
less
than
100%
of
the
cPAD)
for
the
U.
S.
population
(
9%
of
the
cPAD)
and
all
population
subgroups,
with
the
highest
exposed
population
subgroup
being
children
1­
2
years
old
at
43%
of
the
cPAD.
The
results
of
the
chronic
dietary
exposure
analysis
are
reported
below
in
Table
5.
Bitertanol
Dietary
Exposure
Assessment
­
TRED
DP
Barcode:
302880
Page
7
of
12
Table
5.
Summary
of
Dietary
Exposure
and
Risk
for
Triadimenol.

Population
Subgroup
Acute
Dietary
(
95th
Percentile)
Chronic
Dietary
Exposure
(
mg/
kg/
day)
%
aPAD
Exposure
(
mg/
kg/
day)
%
cPAD
General
U.
S.
Population
N/
A
=
not
applicable
N/
A
0.000179
9
All
Infants
(<
1
year
old)
N/
A
N/
A
0.000731
35
Children
1­
2
years
old
N/
A
N/
A
0.000917
43
Children
3­
5
years
old
N/
A
N/
A
0.000467
22
Children
6­
12
years
old
N/
A
N/
A
0.000192
9
Youth
13­
19
years
old
N/
A
N/
A
0.000064
3
Adults
20­
49
years
old
N/
A
N/
A
0.000104
5
Adults
50+
years
old
N/
A
N/
A
0.000177
8
Females
13­
49
years
old
0.000964
2
0.000105
5
The
bolded
values
represent
the
highest
exposed
populations
for
each
of
the
risk
assessments.

VI.
Characterization
of
Inputs/
Outputs
The
analyses
incorporated
the
reassessed
tolerance
level
residue
of
0.50
ppm
for
bananas,
a
DEEM
Version
7.81
default
processing
factor
of
3.9x
for
dried
bananas,
and
100%
crop
treated;
therefore,
the
HED
concludes
that
the
exposure
estimates
provided
in
this
document
are
unlikely
to
underestimate
actual
exposure.

VII.
Conclusions
Acute
and
chronic
dietary
(
food
only)
exposure
assessments
were
conducted
using
the
Dietary
Exposure
Evaluation
Model
software
with
the
Food
Commodity
Intake
Database
(
DEEMFCID
 
,
Version
2.03),
which
uses
food
consumption
data
from
the
USDA's
Continuing
Surveys
of
Food
Intakes
by
Individuals
(
CSFII)
from
1994­
1996
and
1998.
There
are
no
existing
registrations
for
the
use
of
bitertanol
in
the
United
States;
therefore,
the
acute
and
chronic
dietary
risk
assessments
were
conducted
to
support
the
tolerance
reassessment
eligibility
decision
for
bitertanol
use
on
imported
bananas.
The
acute
and
chronic
assessments
show
that
dietary
exposure
and
risk
are
not
of
concern.

VIII.
List
of
Attachments
Attachment
1.
Data
and
Residue
Estimates
Used
in
Dietary
Analyses.
Attachment
2.
Acute
Food
Residue
Input
File.
Attachment
3.
Acute
Food
Results
File.
Attachment
4.
Chronic
Food
Residue
Input
File.
Attachment
5.
Chronic
Food
Results
File.
Bitertanol
Dietary
Exposure
Assessment
­
TRED
DP
Barcode:
302880
Page
8
of
12
Attachment
1.
Data
and
Residue
Estimates
Used
in
Dietary
Analyses.

RAC
Classification1
Data
Source
%
CT
Avg.
2
%
CT
Max.
2
Processing
Factors3
Anticipated
Residue
Estimates/
Tolerance
Acute
(
Tol.,
AR,
RDF)
Chronic
and
Cancer
(
Tol.,
AR)

Banana
NB
or
PB
Reassessed
tolerance
100
100
3.9x
for
dried
Tol
(
0.5)
Tol
(
0.5)

1.
Classification
of
partially
blended
(
PB),
not
blended
(
NB).
2.
No
data
were
available
for
percent
crop
treated,
so
100%
CT
was
used
in
the
dietary
assessments.
3.
The
acute
and
chronic
dietary
exposure
assessments
incorporated
a
DEEM
Version
7.81
default
processing
factor
of
3.9x
for
dried
bananas.
Bitertanol
Dietary
Exposure
Assessment
­
TRED
DP
Barcode:
302880
Page
9
of
12
Attachment
2.
Acute
Food
Residue
Input
File.

U.
S.
Environmental
Protection
Agency
Ver.
2.02
DEEM­
FCID
Acute
analysis
for
BITERTANOL
Residue
file
name:
C:\
Pesticides\
Bitertanol\
Bitertanol
acute.
R98
Analysis
Date
10­
31­
2005
Residue
file
dated:
10­
31­
2005/
22:
45:
41/
8
Reference
dose
(
aRfD)
=
0.05
mg/
kg
bw/
day
Comment:
Food
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
EPA
Crop
Def
Res
Adj.
Factors
Comment
Code
Grp
Food
Name
(
ppm)
#
1
#
2
­­­­­­­­
­­­­
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
­­­­­­­­­­
­­­­­­
­­­­­­
­­­­­­­
95000230
O
Banana
110­
Uncooked;
Fresh
or
N/
S;
Cook
Meth
N/
S
0.500000
1.000
1.000
120­
Uncooked;
Frozen;
Cook
Meth
N/
S
0.500000
1.000
1.000
130­
Uncooked;
Dried;
Cook
Meth
N/
S
0.500000
3.900
1.000
211­
Cooked;
Fresh
or
N/
S;
Baked
0.500000
1.000
1.000
212­
Cooked;
Fresh
or
N/
S;
Boiled
0.500000
1.000
1.000
213­
Cooked;
Fresh
or
N/
S;
Fried
0.500000
1.000
1.000
223­
Cooked;
Frozen;
Fried
0.500000
1.000
1.000
240­
Cooked;
Canned;
Cook
Meth
N/
S
0.500000
1.000
1.000
95000231
O
Banana­
babyfood
211­
Cooked;
Fresh
or
N/
S;
Baked
0.500000
1.000
1.000
230­
Cooked;
Dried;
Cook
Meth
N/
S
0.500000
3.900
1.000
240­
Cooked;
Canned;
Cook
Meth
N/
S
0.500000
1.000
1.000
95000240
O
Banana,
dried
0.500000
3.900
1.000
95000241
O
Banana,
dried­
babyfood
0.500000
3.900
1.000
Bitertanol
Dietary
Exposure
Assessment
­
TRED
DP
Barcode:
302880
Page
10
of
12
Attachment
3.
Acute
Food
Results
File.

U.
S.
Environmental
Protection
Agency
Ver.
2.02
DEEM­
FCID
ACUTE
Analysis
for
BITERTANOL
(
1994­
98
data)
Residue
file:
Bitertanol
acute.
R98
Adjustment
factor
#
2
NOT
used.
Analysis
Date:
10­
31­
2005/
23:
05:
03
Residue
file
dated:
10­
31­
2005/
22:
45:
41/
8
Daily
totals
for
food
and
foodform
consumption
used.
Run
Comment:
"
Food"
===============================================================================

Summary
calculations
(
per
capita):

95th
Percentile
99th
Percentile
99.9th
Percentile
Exposure
%
aRfD
Exposure
%
aRfD
Exposure
%
aRfD
­­­­­­­­­­
­­­­­­­­
­­­­­­­­­­
­­­­­­­­
­­­­­­­­­­
­­­­­­­­
U.
S.
Population:
0.001017
2.03
0.003160
6.32
0.006632
13.26
All
infants:
0.004877
9.75
0.007933
15.87
0.017987
35.97
Children
1­
2
yrs:
0.004854
9.71
0.007400
14.80
0.011502
23.00
Children
3­
5
yrs:
0.003460
6.92
0.005091
10.18
0.009774
19.55
Children
6­
12
yrs:
0.001761
3.52
0.003221
6.44
0.005333
10.67
Youth
13­
19
yrs:
0.000578
1.16
0.001383
2.77
0.002636
5.27
Adults
20­
49
yrs:
0.000890
1.78
0.001356
2.71
0.002289
4.58
Adults
50+
yrs:
0.000952
1.90
0.001406
2.81
0.002386
4.77
Females
13­
49
yrs:
0.000964
1.93
0.001283
2.57
0.002168
4.34
Bitertanol
Dietary
Exposure
Assessment
­
TRED
DP
Barcode:
302880
Page
11
of
12
Attachment
4.
Chronic
Food
Residue
Input
File.

U.
S.
Environmental
Protection
Agency
Ver.
2.00
DEEM­
FCID
Chronic
analysis
for
BITERTANOL
1994­
98
data
Residue
file:
C:\
Pesticides\
Bitertanol\
Bitertanol
chronic.
R98
Adjust.
#
2
NOT
used
Analysis
Date
10­
31­
2005
Residue
file
dated:
10­
31­
2005/
22:
46:
25/
8
Reference
dose
(
RfD)
=
0.00211
mg/
kg
bw/
day
Comment:
Food
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
Food
Crop
Residue
Adj.
Factors
Comment
EPA
Code
Grp
Food
Name
(
ppm)
#
1
#
2
­­­­­­­­
­­­­
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
­­­­­­­­­­
­­­­­­
­­­­­­
­­­­­
­­
95000230
O
Banana
110­
Uncooked;
Fresh
or
N/
S;
Cook
Meth
N/
S
0.500000
1.000
1.000
120­
Uncooked;
Frozen;
Cook
Meth
N/
S
0.500000
1.000
1.000
130­
Uncooked;
Dried;
Cook
Meth
N/
S
0.500000
3.900
1.000
211­
Cooked;
Fresh
or
N/
S;
Baked
0.500000
1.000
1.000
212­
Cooked;
Fresh
or
N/
S;
Boiled
0.500000
1.000
1.000
213­
Cooked;
Fresh
or
N/
S;
Fried
0.500000
1.000
1.000
223­
Cooked;
Frozen;
Fried
0.500000
1.000
1.000
240­
Cooked;
Canned;
Cook
Meth
N/
S
0.500000
1.000
1.000
95000231
O
Banana­
babyfood
211­
Cooked;
Fresh
or
N/
S;
Baked
0.500000
1.000
1.000
230­
Cooked;
Dried;
Cook
Meth
N/
S
0.500000
3.900
1.000
240­
Cooked;
Canned;
Cook
Meth
N/
S
0.500000
1.000
1.000
95000240
O
Banana,
dried
0.500000
3.900
1.000
95000241
O
Banana,
dried­
babyfood
0.500000
3.900
1.000
Bitertanol
Dietary
Exposure
Assessment
­
TRED
DP
Barcode:
302880
Page
12
of
12
Attachment
5.
Chronic
Food
Results
File.

U.
S.
Environmental
Protection
Agency
Ver.
2.00
DEEM­
FCID
Chronic
analysis
for
BITERTANOL
(
1994­
98
data)
Residue
file
name:
C:\
Pesticides\
Bitertanol\
Bitertanol
chronic.
R98
Adjustment
factor
#
2
NOT
used.
Analysis
Date
10­
31­
2005/
23:
08:
33
Residue
file
dated:
10­
31­
2005/
22:
46:
25/
8
Reference
dose
(
RfD,
Chronic)
=
0.00211
mg/
kg
bw/
day
COMMENT
1:
Food
===============================================================================
Total
exposure
by
population
subgroup
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­

Total
Exposure
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
Population
mg/
kg
Percent
of
Subgroup
body
wt/
day
Rfd
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
­­­­­­­­­­­­­
­­­­­­­­­­­­­­­
U.
S.
Population
(
total)
0.000179
8.5%

U.
S.
Population
(
spring
season)
0.000178
8.4%
U.
S.
Population
(
summer
season)
0.000166
7.9%
U.
S.
Population
(
autumn
season)
0.000182
8.6%
U.
S.
Population
(
winter
season)
0.000194
9.2%

Northeast
region
0.000183
8.7%
Midwest
region
0.000178
8.4%
Southern
region
0.000152
7.2%
Western
region
0.000222
10.5%

Hispanics
0.000241
11.4%
Non­
hispanic
whites
0.000176
8.3%
Non­
hispanic
blacks
0.000134
6.3%
Non­
hisp/
non­
white/
non­
black
0.000222
10.5%

All
infants
(<
1
year)
0.000731
34.7%
Nursing
infants
0.000516
24.5%
Non­
nursing
infants
0.000813
38.5%
Children
1­
6
yrs
0.000587
27.8%
Children
7­
12
yrs
0.000175
8.3%

Females
13­
19
(
not
preg
or
nursing)
0.000055
2.6%
Females
20+
(
not
preg
or
nursing)
0.000140
6.6%
Females
13­
50
yrs
0.000131
6.2%
Females
13+
(
preg/
not
nursing)
0.000143
6.8%
Females
13+
(
nursing)
0.000183
8.7%

Males
13­
19
yrs
0.000074
3.5%
Males
20+
yrs
0.000119
5.6%
Seniors
55+
0.000182
8.6%

Children
1­
2
yrs
0.000917
43.4%
Children
3­
5
yrs
0.000467
22.1%
Children
6­
12
yrs
0.000192
9.1%
Youth
13­
19
yrs
0.000064
3.1%
Adults
20­
49
yrs
0.000104
4.9%
Adults
50+
yrs
0.000177
8.4%
Females
13­
49
yrs
0.000105
5.0%