Document ID: EPA-HQ-OPP-2006-0327-0006
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2006-08-30T04:00Z

Bifenazate
(
000586)
Dietary
Exposure
and
Risk
Assessment
D330587
page
1
of
15
UNITED
STATES
ENVIRONMENTAL
PROTECTION
AGENCY
WASHINGTON,
D.
C.
20460
OFFICE
OF
PREVENTION,
PESTICIDES
AND
TOXIC
SUBSTANCES
MEMORANDUM
Date:
19­
July­
2006
Subject:
Bifenazate
­
Chronic
Dietary
Exposure
and
Risk
Assessment.
Application
of
Bifenazate
to
succulent
Pea,
Tuberous
and
Corm
Vegetables
(
subgroup
1c),
and
Stone
Fruit.
PC
Code:
000586.
DP
No.:
330587.
PP
No.:
5E6992.
Decision
No.:
360901.

Reviewer/
To:
Tom
Bloem,
Chemist
Registration
Action
Branch
1/
Health
Effects
Division
(
RAB1/
HED;
7509C)

Through:
Toiya
Goodlow,
Chemist,
Reregistration
Branch
1
(
RRB1)
Christina
Swartz,
Branch
Chief
RAB2
Dietary
Exposure
Science
Advisory
Committee
(
DESAC)

George
Kramer,
Ph.
D.,
Senior
Chemist
RAB1/
HED
(
7509C)

Executive
Summary
Chronic
dietary
risk
assessments
were
conducted
using
the
Dietary
Exposure
Evaluation
Model
­
Food
Consumption
Intake
Database
(
DEEM­
FCID
 
,
ver.
2.03).
DEEM­
FCID
 
incorporates
the
food
consumption
data
from
the
USDA's
Continuing
Surveys
of
Food
Intakes
by
Individuals
(
CSFII;
1994­
1996
and
1998).
The
chronic
analyses
incorporated
tolerance­
level
residues
for
all
commodities
excluding
squash,
peach,
tomato,
and
soybean
(
average
field­
trial
residues
were
assumed)
and
milk
(
anticipated
residue
was
assumed).
The
chronic
analyses
incorporated
average
percent
crop
treated
information
provided
by
the
Biological
Economic
Analysis
Division
(
BEAD;
J.
Carter,
13­
Jul­
2006).
DEEM
 
(
ver.
7.81)
default
processing
factors
were
assumed
for
all
commodities
excluding
apple
juice,
grape
juice,
wine/
sherry,
tomato
paste,
and
tomato
puree.
The
processing
factors
for
these
commodities
were
reduced
to
0.23,
0.17,
0.17,
5.0,
and
5.0,
respectively,
based
on
data
from
processing
studies.
The
analyses
also
included
the
chronic
surface
water
point
estimate
generated
using
the
Tier
1
model
FIRST
and
the
strawberry
application
scenario
(
2
x
0.50
lb
ai/
acre;
21­
day
retreatment
interval
(
RTI);
highest
registered/
proposed
rate).
The
chronic
exposure
estimates
are
 
94%
cPAD
and
are,
therefore,
less
than
HED's
level
of
concern
(
children
1­
2
years
old
were
the
most
highly
exposed
population).
Based
on
a
critical­
commodity
analysis
conducted
in
DEEM­
FCID
 
,
the
major
contributor
to
the
risk
was
soybean
oil
(
16­
55%
of
the
cPAD).
Bifenazate
(
000586)
Dietary
Exposure
and
Risk
Assessment
D330587
page
2
of
15
I.
Introduction
Dietary
risk
assessment
incorporates
both
exposure
and
toxicity
of
a
given
pesticide.
For
chronic
assessments,
the
risk
is
expressed
as
a
percentage
of
a
maximum
acceptable
dose.
This
is
the
PAD,
which
HED
has
concluded
will
result
in
no
unreasonable
adverse
health
effects.
The
PAD
is
the
RfD
divided
by
the
Food
Quality
Protection
Act
(
FQPA)
Safety
Factor.
Dietary
risk
is
expressed
as
a
percentage
of
the
PAD.
HED
is
concerned
when
estimated
dietary
risk
exceeds
100%
of
the
PAD.
References
which
discuss
the
chronic
risk
assessment
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).
The
most
recent
dietary
exposure
assessment
for
bifenazate
was
performed
on
26­
April­
2005
(
D315873,
T.
Bloem).

II.
Residue
Information
Residues
of
Concern
in
Plants,
Livestock,
and
Drinking
Water:
Table
1
is
a
summary
of
the
HED
Metabolism
Assessment
Review
Committee
(
MARC)
decisions
concerning
the
residues
of
concern
in
plants,
livestock,
rotational
crops,
and
drinking
water
(
D276801,
T.
Bloem,
16­
Aug­
2001;
D290053,
T.
Bloem,
29­
May­
2003).

Subsequent
to
these
decisions,
the
petitioner
submitted
a
radiovalidation
study
for
the
livestock
enforcement
method
(
46691301.
der.
wpd;
D313261,
T.
Bloem,
5­
July­
2006).
These
data
indicated
that,
contrary
to
what
was
presented
in
the
ruminant
metabolism
study,
the
major
residue
in
milk
is
D9569
not
A1530­
sulfate.
HED
requested
data
clarifying
this
discrepancy.
HED
notes
that
the
ruminant
feeding
study
did
not
monitor
for
D9569
(
monitored
for
residues
of
bifenazate,
D3598,
A1530,
and
A1530­
sulfate).

Table
1.
Residues
for
Tolerance
Expression
and
Risk
Assessment
Matrix
Residues
included
in
Risk
Assessment
Residues
included
in
Tolerance
Expression
Plants
bifenazate,
D3598
(
expressed
as
parent)
bifenazate,
D3598
(
expressed
as
parent)

Livestock
(
excluding
fat)
2
bifenazate,
D3598
(
expressed
as
parent),
A1530,
A1530­
sulfate
(
expressed
as
A1530)
bifenazate,
D3598
(
expressed
as
parent),
A1530,
A1530­
sulfate
(
expressed
as
A1530)

Livestock
­
fat
bifenazate,
D3598
(
expressed
as
parent)
bifenazate,
D3598
(
expressed
as
parent)

Rotational
Crops
could
not
be
determined1
could
not
be
determined1
Drinking
Water
D1989
D1989
1
Based
on
the
results
of
the
confined
rotational
crop
study
conducted
0.5
lb
ai/
acre
and
the
application
rate
for
the
registered
crops
which
are
likely
to
be
rotated,
HED
concluded
that
residues
in
rotated
crops
were
unlikely
and
that
tolerances
were
unnecessary.
2
Subsequent
to
the
decision
indicated
above,
the
petitioner
submitted
radiovalidation
data
for
the
livestock
enforcement
method
(
46691301.
der.
wpd;
D313261,
T.
Bloem,
5­
July­
2006).
These
data
indicated
that,
contrary
to
what
was
presented
in
the
ruminant
metabolism
study,
the
major
residue
in
milk
is
D9569
not
A1530­
sulfate.
HED
requested
data
clarifying
this
discrepancy.
Bifenazate
(
000586)
Dietary
Exposure
and
Risk
Assessment
D330587
page
3
of
15
Established/
Recommended
Tolerances:
Bifenazate
is
currently
registered
for
application
to
pome
fruit,
fruiting
vegetable,
cucurbit
vegetable,
tree
nut,
nectarine,
peach,
plum,
grape,
strawberry,
cotton,
hops,
okra,
peppermint,
and
spearmint
with
tolerances
ranging
from
0.1
­
35
ppm
(
40
CFR
180.572(
a)(
1)).
Section
18
registrations
have
also
been
established
for
application
of
bifenazate
to
cherry,
tomato,
soybean,
potato,
and
timothy
with
tolerances
ranging
from
0.05­
150
ppm
(
40
CFR
180.572(
b)).
Tolerances,
as
a
result
of
secondary
residues,
are
established
in
milk,
ruminant
meat,
ruminant
fat,
and
ruminant
meat
byproducts
at
0.02­
0.10
ppm
(
40
CFR
180.572(
a)(
1)
and
(
a)(
2)).

As
part
of
the
current
reviews,
HED
recommended
for
the
establishment
of
the
following
tolerances
for
the
combined
residues
of
bifenazate
and
D3598
(
succulent
pea
and
tuberous
and
corm
vegetables
­
D324430,
T.
Bloem,
5­
July­
2006;
stone
fruit,
plum,
and
fat
(
cattle,
goat,
hog,
horse,
sheep)
­
D313261,
T.
Bloem,
5­
July­
2006):

pea,
garden,
succulent
....................................................................................................
0.20
ppm
pea,
edible
podded,
succulent
...........................................................................................
4.0
ppm
vegetable,
tuberous
and
corm,
subgroup
1c
....................................................................
0.10
ppm
fruit,
stone,
group
12
(
except
plum)....................................................................................
2.5
ppm
plum...............................................................................................................................
0.20
ppm
fat
(
cattle,
goat,
hog,
horse,
sheep).................................................................................
0.10
ppm
Plant/
Livestock
Residues
Used
in
the
Chronic
Risk
Assessments:
The
chronic
analyses
incorporated
established/
recommended
tolerance­
level
residues
for
all
registered/
proposed
crops
excluding
milk
(
see
next
paragraph),
squash,
peach,
tomato,
soybean,
and
soybean
oil.
For
squash,
peach,
tomato,
soybean,
and
soybean
oil,
the
following
average
field
trial
residues
were
assumed:
squash
­
0.09
ppm
(
D290053,
T.
Bloem,
29­
May­
2003;
D286170,
20­
Apr­
2004),
peach
­
0.37
ppm
(
D313261,
T.
Bloem,
12­
Jul­
2006),
tomato
­
0.19
ppm
(
45772005.
der.
wpd),
soybean
­
0.49
ppm
(
D308822,
J.
Tyler,
29­
Oct­
2004),
and
soybean
oil
­
5.9
ppm
(
0.49
ppm
x
theoretical
processing
factor
of
12.0
=
5.9
ppm;
D308822,
J.
Tyler,
29­
Oct­
2004).
DEEM
 
(
ver.
7.81)
default
processing
factors
were
assumed
for
all
commodities
excluding
apple
juice,
grape
juice,
wine/
sherry,
tomato
paste,
and
tomato
puree.
The
processing
factors
for
these
commodities
were
reduced
to
0.23,
0.17,
0.17,
5.0,
and
5.0,
respectively,
based
on
data
from
processing
studies
(
apple
and
grape
­
D277089,
T.
Bloem,
16­
Aug­
2001;
tomato
­
45772006.
der2.
wpd).
HED
notes
that
the
Section
18
tart
cherry
tolerance
of
5.0
ppm,
which
was
based
on
data
translations
(
D317316,
T.
Bloem
et
al.,
5­
May­
2005),
is
greater
than
the
HED
recommended
stone
fruit
tolerance.
Since
the
Section
18
cherry
application
scenario
is
identical
to
the
Section
3
registration,
the
HED­
recommended
stone
fruit
tolerance
indicated
above
was
used
for
cherry.

As
indicated
above,
the
petitioner
submitted
data
which
indicates
that
the
major
residue
in
milk
is
D9569
and
not
A1530­
sulfate
as
previously
indicated.
HED
requested
that
the
petitioner
submit
data
confirming
the
identity
of
the
major
residues
in
milk
(
D313261,
T.
Bloem,
12­
July­
2006).
The
ruminant
metabolism
study
indicated
that
major
residue
in
milk,
originally
identified
as
A1530­
sulfate
but
now
thought
to
be
D9569,
occupied
41%
of
the
total
radioactive
residue
(
TRR)
and
combined
residues
of
bifenazate
and
D3598
occupied
9%
of
the
TRR.
Therefore,
the
ratio
of
the
major
residue
in
milk
to
combined
residues
of
bifenazate/
D3598
is
4.6.
The
ruminant
feeding
study
resulted
in
combined
residues
of
bifenazate/
D3598
in/
on
milk
of
<
0.01
ppm
Bifenazate
(
000586)
Dietary
Exposure
and
Risk
Assessment
D330587
page
4
of
15
(<
LOQ)
at
a
10
ppm
dietary
burden
(
A1530
was
included
as
a
residue
of
concern
only
because
the
analtical
method
did
not
differentiate
between
A1530­
sulfate
and
A1530).
Based
on
the
current
maximum
theoretical
dietary
burden
of
6.99
ppm
and
4.6
ratio
from
the
ruminant
metabolism
study
and
assuming
a
combined
bifenazate/
D3598
residue
of
0.01
ppm,
a
milk
residue
of
0.0391
ppm
is
calculated
((
0.01
+
(
0.01
x
4.6))
x
(
6.99
÷
10)
=
0.0391).
Residues
in
milk
fat
were
set
to
0.98
ppm
(
milk
residue
(
0.0391
ppm)
x
25
=
0.98
ppm)
based
on
the
maximum
theoretical
concentration
factor
of
25x
for
milk
fat
and
the
ruminant
feeding
study
which
resulted
in
higher
residues
in
fat
than
in
meat
and
meat
byproducts.

Percent
Crop
Treated
Information:
Average
percent
crop
treated
information,
provided
by
BEAD,
were
used
for
numerous
registered
crops
(
attachment
1;
J.
Carter,
13­
Jul­
2006).

Drinking
Water
Residues
Used
in
the
Chronic
Risk
Assessments:
Surface
and
ground
water
estimated
environmental
concentrations
(
EECs)
were
generated
using
the
FIRST
(
87%
cropped
area)
and
SCI­
GROW
models,
respectively.
Both
models
were
ran
using
the
strawberry
application
scenario
(
2
x
0.50
lb
ai/
acre;
21­
day
RTI;
highest
registered/
proposed
rate).
The
resulting
chronic
EECs
in
ground
and
surface
water
were
<
0.001
ppb
and
6.38
ppb,
respectively
(
EFED
memo;
D286171,
T.
Nguyen,
10­
Oct­
2003).
Since
the
surface
water
concentration
was
the
highest,
the
chronic
dietary
run
was
conducted
assuming
a
residue
of
0.00638
ppm
for
all
water
sources
(
direct
and
indirect).

III.
Program
and
Consumption
Information
Chronic
dietary
exposure
assessments
were
conducted
using
DEEM­
FCID
 
(
ver.
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.
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.
Bifenazate
(
000586)
Dietary
Exposure
and
Risk
Assessment
D330587
page
5
of
15
IV.
Toxicological
Information
The
HED
Hazard
Identification
Assessment
Review
Committee
(
HIARC)
met
on
four
occasions
to
examine
the
toxicology
database
for
bifenazate
and
to
determine
the
appropriate
toxicological
endpoints
for
dietary
and
occupational/
residential
exposure
assessment
(
meeting
dates
­
21­
Aug­
2001
(
TXR
No.
0014658),
24­
Apr­
2001
(
TXR
No.
0014576),
13­
Apr­
1999
(
TXR
No.
0013335),
and
4­
Feb­
1999
(
TXR
No.
0013277)).
The
HED
Food
Quality
Protection
Act
Safety
Factor
Committee
(
FQPA
SFC)
met
on
27­
August­
2001
to
evaluate
the
bifenazate
toxicological
database
in
reference
to
the
potential
for
enhanced
sensitivity
to
infants
and
children
(
TXR
No.
0014661).
Based
on
the
conclusions
made
by
the
HIARC
and
FQPA
SFC,
the
complete
residue
chemistry
and
environmental
fate
databases,
and
the
conservative
assumptions
used
when
generating
the
dietary
exposure
estimates,
HED
concludes
that
the
FQPA
SF
should
be
reduced
to
1x.
A
summary
of
the
toxicological
doses
and
endpoints
selected
for
dietary
exposure
assessment
is
provided
in
Table
2.

Table
2.
Toxicological
Endpoints
for
Dietary
Analysis
Exposure
Scenario
Dose
Used
in
Risk
Assessment,
UF
FQPA
SF
and
Level
of
Concern
for
Risk
Assessment
Study
and
Toxicological
Effects
Acute
Dietary;

all
populations
An
acute
dietary
endpoint
was
not
selected
based
on
the
absence
of
an
appropriate
endpoint
attributed
to
a
single
dose.

Chronic
Dietary;

all
populations
NOAEL=
1.0
mg/
kg/
day
UF
=
100
cRfD
=
0.01
mg/
kg/
day
FQPA
SF
=
1X
cPAD
=
0.01
mg/
kg/
day
LOAEL
=
8.9/
10.4
mg/
kg/
day
[
M/
F]
based
on
changes
in
hematological
and
clinical
chemistry
parameters,
and
histopathology
in
bone
marrow,
liver,
and
kidney
in
the
One
Year
Dog
Feeding
Study
Cancer
bifenazate
is
classified
as
"
not
likely"
to
be
a
human
carcinogen
1
UF
=
uncertainty
factor,
FQPA
SF
=
FQPA
safety
factor,
NOAEL
=
no
observed
adverse
effect
level,
LOAEL
=
lowest
observed
adverse
effect
level,
cPAD
=
chronic
population
adjusted
dose,
RfD
=
reference
dose.

V.
Results/
Discussion
The
chronic
dietary
risk
estimates
are
 
94%
cPAD
and
are,
therefore,
less
than
HED's
level
of
concern
(
children
1­
2
years
old
were
the
most
highly
exposed
population).

Table
3:
Summary
of
Chronic
Dietary
Exposure
and
Risk
for
Bifenazate
(
drinking
water
included)
Chronic
Population
Subgroup
cPAD
(
mg/
kg/
day)
Exposure
(
mg/
kg/
day)
%
cPAD
General
U.
S.
Population
0.003835
38
All
Infants
(<
1
year
old)
0.007938
79
Children
1­
2
years
old
0.009386
94
Children
3­
5
years
old
0.008595
86
Children
6­
12
years
old
0.005942
59
Youth
13­
19
years
old
0.003712
37
Adults
20­
49
years
old
0.003084
31
Adults
50+
years
old
0.002554
26
Females
13­
49
years
old
0.01
0.002864
29
Bifenazate
(
000586)
Dietary
Exposure
and
Risk
Assessment
D330587
page
6
of
15
VI.
Characterization
of
Inputs/
Outputs
The
chronic
analyses
were
refined
through
the
use
of
average
field
trial
residues,
experimentallydetermined
processing
factors,
and
average
percent
crop
treated
information.
HED
notes
that
registration
for
application
to
cherry
tomato
was
approved
without
the
submission
of
cherry
tomato
field
trial
data
(
D297604,
T.
Bloem,
12­
July­
2006)
and
that
the
current
analysis
incorporated
average
tomato
field
trial
residues.
Since
the
analysis
assumed
the
average
tomato
greenhouse
residue
of
0.19
ppm
(
average
field
tomato
residue
was
0.11
ppm)
and
since
the
analysis
incorporated
percent
crop
treated
information
for
tomato
(
5%),
HED
concludes
that
the
lack
of
cherry
tomato
residue
data
will
not
significantly
affect
the
analysis.
HED
concludes
that
the
exposure
estimates
provided
in
this
document
are
unlikely
to
underestimate
actual
exposure
for
the
following
reasons:
(
1)
the
analysis
incorporated
tolerance
level
residues
or
made
use
of
average
residues
derived
from
crop
field
trial
studies
(
maximum
application
rate
and
minimum
preharvest
interval);
(
2)
incorporated
maximum
theoretical
processing
factors
for
several
commodities
including
a12x
processing
factor
for
soybean
oil
(
D305565,
J.
Tyler,
29­
Oct­
2004);
and
(
3)
the
surface
drinking
water
estimate
incorporated
into
the
analysis
was
generated
with
the
assumption
that
87%
of
the
basin
was
cropped
and
100%
of
the
cropped
area
treated.

Based
on
a
critical­
commodity
analysis
conducted
in
DEEM­
FCID
 
,
the
major
contributor
to
the
risk
was
soybean
oil
(
16­
55%
of
the
cPAD).

VII.
Conclusions
The
chronic
dietary
risk
estimates
are
 
94%
cPAD
and
are
therefore
less
than
HED's
level
of
concern
(
children
1­
2
years
old
were
the
most
highly
exposed
population).

VIII.
List
of
Attachments
Attachment
1:
BEAD
Average
Percent
Crop
Treated
Information
Attachment
2:
DEEM­
FCID
 
chronic
residue
file
Attachment
3:
DEEM­
FCID
 
chronic
exposure
estimates
cc
Daniel
Rosenblatt/
Sidney
Jackson
(
RM
05)
and
Daniel
Kenny/
Rita
Kumar
(
RM
01)
T.
Bloem:
S10945:
Potomac
Yard:(
703)
605­
0217:
7509P
Bifenazate
(
000586)
Dietary
Exposure
and
Risk
Assessment
D330587
page
7
of
15
Attachment
1:
BEAD
Average
Percent
Crop
Treated
Information
Bifenazate
(
000586)
Dietary
Exposure
and
Risk
Assessment
D330587
page
8
of
15
Bifenazate
(
000586)
Dietary
Exposure
and
Risk
Assessment
D330587
page
9
of
15
Bifenazate
(
000586)
Dietary
Exposure
and
Risk
Assessment
D330587
page
10
of
15
Attachment
2:
DEEM­
FCID
 
chronic
residue
file
Filename:
C:\
Documents
and
Settings\
tbloem\
bifenazate\
tuberous
and
corm
vegetables
and
succulent
pea\
000586c.
R98
Chemical:
bifenazate
RfD(
Chronic):
.01
mg/
kg
bw/
day
NOEL(
Chronic):
0
mg/
kg
bw/
day
RfD(
Acute):
0
mg/
kg
bw/
day
NOEL(
Acute):
0
mg/
kg
bw/
day
Date
created/
last
modified:
07­
14­
2006/
13:
36:
39/
8
Program
ver.
2.03
Comment:
no
acute
endpoint
identified;
FQPA
SF
of
1x
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
­­
EPA
Crop
Def
Res
Adj.
Factors
Comment
Code
Grp
Commodity
Name
(
ppm)
#
1
#
2
­­­­­­­­
­­­­
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
­­­­­­­­­­
­­­­­­
­­­­­­
­­­­
­­­
95001280
O
Cottonseed,
oil
0.750000
1.000
1.000
95001281
O
Cottonseed,
oil­
babyfood
0.750000
1.000
1.000
95001750
O
Grape
0.750000
1.000
0.050
95001760
O
Grape,
juice
0.750000
0.170
0.050
95001761
O
Grape,
juice­
babyfood
0.750000
0.170
0.050
95001770
O
Grape,
leaves
0.750000
1.000
0.050
95001780
O
Grape,
raisin
1.200000
1.000
0.050
95001790
O
Grape,
wine
and
sherry
0.750000
0.170
0.050
95001880
O
Hop
15.000000
1.000
1.000
95002750
O
Peppermint
25.000000
1.000
1.000
95002760
O
Peppermint,
oil
25.000000
1.000
1.000
95003520
O
Spearmint
25.000000
1.000
1.000
95003530
O
Spearmint,
oil
25.000000
1.000
1.000
95003590
O
Strawberry
1.500000
1.000
0.250
95003591
O
Strawberry­
babyfood
1.500000
1.000
0.250
95003600
O
Strawberry,
juice
1.500000
1.000
0.250
95003601
O
Strawberry,
juice­
babyfood
1.500000
1.000
0.250
86010000
O
Water,
direct,
all
sources
0.006380
1.000
1.000
86020000
O
Water,
indirect,
all
sources
0.006380
1.000
1.000
21000440
M
Beef,
meat
0.020000
1.000
1.000
21000441
M
Beef,
meat­
babyfood
0.020000
1.000
1.000
21000450
M
Beef,
meat,
dried
0.020000
1.920
1.000
21000460
M
Beef,
meat
byproducts
0.020000
1.000
1.000
21000461
M
Beef,
meat
byproducts­
babyfood
0.020000
1.000
1.000
21000470
M
Beef,
fat
0.100000
1.000
1.000
21000471
M
Beef,
fat­
babyfood
0.100000
1.000
1.000
21000480
M
Beef,
kidney
0.020000
1.000
1.000
21000490
M
Beef,
liver
0.020000
1.000
1.000
21000491
M
Beef,
liver­
babyfood
0.020000
1.000
1.000
23001690
M
Goat,
meat
0.020000
1.000
1.000
23001700
M
Goat,
meat
byproducts
0.020000
1.000
1.000
23001710
M
Goat,
fat
0.100000
1.000
1.000
23001720
M
Goat,
kidney
0.020000
1.000
1.000
23001730
M
Goat,
liver
0.020000
1.000
1.000
24001890
M
Horse,
meat
0.020000
1.000
1.000
28002210
M
Meat,
game
0.020000
1.000
1.000
25002900
M
Pork,
meat
0.020000
1.000
1.000
25002901
M
Pork,
meat­
babyfood
0.020000
1.000
1.000
25002910
M
Pork,
skin
0.100000
1.000
1.000
25002920
M
Pork,
meat
byproducts
0.020000
1.000
1.000
25002921
M
Pork,
meat
byproducts­
babyfood
0.020000
1.000
1.000
25002930
M
Pork,
fat
0.100000
1.000
1.000
25002931
M
Pork,
fat­
babyfood
0.100000
1.000
1.000
25002940
M
Pork,
kidney
0.020000
1.000
1.000
25002950
M
Pork,
liver
0.020000
1.000
1.000
29003120
M
Rabbit,
meat
0.020000
1.000
1.000
Bifenazate
(
000586)
Dietary
Exposure
and
Risk
Assessment
D330587
page
11
of
15
26003390
M
Sheep,
meat
0.020000
1.000
1.000
26003391
M
Sheep,
meat­
babyfood
0.020000
1.000
1.000
26003400
M
Sheep,
meat
byproducts
0.020000
1.000
1.000
26003410
M
Sheep,
fat
0.100000
1.000
1.000
26003411
M
Sheep,
fat­
babyfood
0.100000
1.000
1.000
26003420
M
Sheep,
kidney
0.020000
1.000
1.000
26003430
M
Sheep,
liver
0.020000
1.000
1.000
27002220
D
Milk,
fat
0.980000
1.000
1.000
27002221
D
Milk,
fat
­
baby
food/
infant
for
0.980000
1.000
1.000
27012230
D
Milk,
nonfat
solids
0.039100
1.000
1.000
27012231
D
Milk,
nonfat
solids­
baby
food/
in
0.039100
1.000
1.000
27022240
D
Milk,
water
0.039100
1.000
1.000
27022241
D
Milk,
water­
babyfood/
infant
form
0.039100
1.000
1.000
27032251
D
Milk,
sugar
(
lactose)­
baby
food/
0.039100
1.000
1.000
01030150
1CD
Arrowroot,
flour
0.100000
1.000
1.000
01030151
1CD
Arrowroot,
flour­
babyfood
0.100000
1.000
1.000
01030170
1CD
Artichoke,
Jerusalem
0.100000
1.000
1.000
01030820
1CD
Cassava
0.100000
1.000
1.000
01030821
1CD
Cassava­
babyfood
0.100000
1.000
1.000
01031390
1CD
Dasheen,
corm
0.100000
1.000
1.000
01031660
1CD
Ginger
0.100000
1.000
1.000
01031661
1CD
Ginger­
babyfood
0.100000
1.000
1.000
01031670
1CD
Ginger,
dried
0.100000
1.000
1.000
01032960
1C
Potato,
chips
0.100000
1.000
1.000
01032970
1C
Potato,
dry
(
granules/
flakes)
0.100000
6.500
1.000
01032971
1C
Potato,
dry
(
granules/
flakes)­
b
0.100000
6.500
1.000
01032980
1C
Potato,
flour
0.100000
6.500
1.000
01032981
1C
Potato,
flour­
babyfood
0.100000
6.500
1.000
01032990
1C
Potato,
tuber,
w/
peel
0.100000
1.000
1.000
01032991
1C
Potato,
tuber,
w/
peel­
babyfood
0.100000
1.000
1.000
01033000
1C
Potato,
tuber,
w/
o
peel
0.100000
1.000
1.000
01033001
1C
Potato,
tuber,
w/
o
peel­
babyfood
0.100000
1.000
1.000
01033660
1CD
Sweet
potato
0.100000
1.000
1.000
01033661
1CD
Sweet
potato­
babyfood
0.100000
1.000
1.000
01033710
1CD
Tanier,
corm
0.100000
1.000
1.000
01033870
1CD
Turmeric
0.100000
1.000
1.000
01034060
1CD
Yam,
true
0.100000
1.000
1.000
01034070
1CD
Yam
bean
0.100000
1.000
1.000
06020330
6B
Bean,
cowpea,
succulent
0.200000
1.000
1.000
06030980
6C
Chickpea,
seed
0.200000
1.000
1.000
06030981
6C
Chickpea,
seed­
babyfood
0.200000
1.000
1.000
06030990
6C
Chickpea,
flour
0.200000
1.000
1.000
06022550
6B
Pea,
succulent
0.200000
1.000
1.000
06022551
6B
Pea,
succulent­
babyfood
0.200000
1.000
1.000
06012570
6A
Pea,
edible
podded,
succulent
4.000000
1.000
1.000
06022590
6B
Pea,
pigeon,
succulent
0.200000
1.000
1.000
06003470
6
Soybean,
seed
0.490000
1.000
1.000
06003480
6
Soybean,
flour
0.490000
1.000
1.000
06003481
6
Soybean,
flour­
babyfood
0.490000
1.000
1.000
06003490
6
Soybean,
soy
milk
0.490000
1.000
1.000
06003491
6
Soybean,
soy
milk­
babyfood
or
in
0.490000
1.000
1.000
06003500
6
Soybean,
oil
5.900000
1.000
1.000
06003501
6
Soybean,
oil­
babyfood
5.900000
1.000
1.000
08001480
8
Eggplant
2.000000
1.000
1.000
08002340
8
Okra
2.000000
1.000
1.000
08002700
8
Pepper,
bell
2.000000
1.000
0.010
08002701
8
Pepper,
bell­
babyfood
2.000000
1.000
0.010
08002710
8
Pepper,
bell,
dried
2.000000
1.000
0.010
08002711
8
Pepper,
bell,
dried­
babyfood
2.000000
1.000
0.010
08002720
8
Pepper,
nonbell
2.000000
1.000
0.010
08002721
8
Pepper,
nonbell­
babyfood
2.000000
1.000
0.010
08002730
8
Pepper,
nonbell,
dried
2.000000
1.000
0.010
08003740
8
Tomatillo
2.000000
1.000
1.000
Bifenazate
(
000586)
Dietary
Exposure
and
Risk
Assessment
D330587
page
12
of
15
08003750
8
Tomato
0.190000
1.000
0.050
08003751
8
Tomato­
babyfood
0.190000
1.000
0.050
08003760
8
Tomato,
paste
0.190000
5.000
0.050
08003761
8
Tomato,
paste­
babyfood
0.190000
5.000
0.050
08003770
8
Tomato,
puree
0.190000
5.000
0.050
08003771
8
Tomato,
puree­
babyfood
0.190000
5.000
0.050
08003780
8
Tomato,
dried
0.190000
14.300
0.050
08003781
8
Tomato,
dried­
babyfood
0.190000
14.300
0.050
08003790
8
Tomato,
juice
0.190000
1.500
0.050
09020210
9B
Balsam
pear
0.750000
1.000
1.000
09010750
9A
Cantaloupe
0.750000
1.000
1.000
09010800
9A
Casaba
0.750000
1.000
1.000
09020880
9B
Chayote,
fruit
0.750000
1.000
1.000
09021020
9B
Chinese
waxgourd
0.750000
1.000
1.000
09021350
9B
Cucumber
0.750000
1.000
0.010
09011870
9A
Honeydew
melon
0.750000
1.000
1.000
09023080
9B
Pumpkin
0.750000
1.000
1.000
09023090
9B
Pumpkin,
seed
0.750000
1.000
1.000
09023560
9B
Squash,
summer
0.090000
1.000
1.000
09023561
9B
Squash,
summer­
babyfood
0.090000
1.000
1.000
09023570
9B
Squash,
winter
0.090000
1.000
1.000
09023571
9B
Squash,
winter­
babyfood
0.090000
1.000
1.000
09013990
9A
Watermelon
0.750000
1.000
0.010
09014000
9A
Watermelon,
juice
0.750000
1.000
0.010
11000070
11
Apple,
fruit
with
peel
0.750000
1.000
0.010
11000080
11
Apple,
peeled
fruit
0.750000
1.000
0.010
11000081
11
Apple,
peeled
fruit­
babyfood
0.750000
1.000
0.010
11000090
11
Apple,
dried
0.750000
8.000
0.010
11000091
11
Apple,
dried­
babyfood
0.750000
8.000
0.010
11000100
11
Apple,
juice
0.750000
0.230
0.010
11000101
11
Apple,
juice­
babyfood
0.750000
0.230
0.010
11000110
11
Apple,
sauce
0.750000
1.000
0.010
11000111
11
Apple,
sauce­
babyfood
0.750000
1.000
0.010
11001290
11
Crabapple
0.750000
1.000
1.000
11002100
11
Loquat
0.750000
1.000
1.000
11002660
11
Pear
0.750000
1.000
0.100
11002661
11
Pear­
babyfood
0.750000
1.000
0.100
11002670
11
Pear,
dried
0.750000
6.250
0.100
11002680
11
Pear,
juice
0.750000
1.000
0.100
11002681
11
Pear,
juice­
babyfood
0.750000
1.000
0.100
11003100
11
Quince
0.750000
1.000
1.000
12000120
12
Apricot
2.500000
1.000
0.010
12000121
12
Apricot­
babyfood
2.500000
1.000
0.010
12000130
12
Apricot,
dried
2.500000
6.000
0.010
12000140
12
Apricot,
juice
2.500000
1.000
0.010
12000141
12
Apricot,
juice­
babyfood
2.500000
1.000
0.010
12000900
12
Cherry
2.500000
1.000
1.000
12000901
12
Cherry­
babyfood
2.500000
1.000
1.000
12000910
12
Cherry,
juice
2.500000
1.500
1.000
12000911
12
Cherry,
juice­
babyfood
2.500000
1.500
1.000
12002300
12
Nectarine
2.500000
1.000
0.050
12002600
12
Peach
0.370000
1.000
0.100
12002601
12
Peach­
babyfood
0.370000
1.000
0.100
12002610
12
Peach,
dried
0.370000
7.000
0.100
12002611
12
Peach,
dried­
babyfood
0.370000
7.000
0.100
12002620
12
Peach,
juice
0.370000
1.000
0.100
12002621
12
Peach,
juice­
babyfood
0.370000
1.000
0.100
12002850
12
Plum
0.200000
1.000
0.050
12002851
12
Plum­
babyfood
0.200000
1.000
0.050
12002860
12
Plum,
prune,
fresh
0.200000
1.000
0.050
12002861
12
Plum,
prune,
fresh­
babyfood
0.200000
1.000
0.050
12002870
12
Plum,
prune,
dried
0.200000
5.000
0.050
12002871
12
Plum,
prune,
dried­
babyfood
0.200000
5.000
0.050
Bifenazate
(
000586)
Dietary
Exposure
and
Risk
Assessment
D330587
page
13
of
15
12002880
12
Plum,
prune,
juice
0.200000
1.400
0.050
12002881
12
Plum,
prune,
juice­
babyfood
0.200000
1.400
0.050
14000030
14
Almond
0.200000
1.000
0.010
14000031
14
Almond­
babyfood
0.200000
1.000
0.010
14000040
14
Almond,
oil
0.200000
1.000
0.010
14000041
14
Almond,
oil­
babyfood
0.200000
1.000
0.010
14000590
14
Brazil
nut
0.200000
1.000
1.000
14000680
14
Butternut
0.200000
1.000
1.000
14000810
14
Cashew
0.200000
1.000
1.000
14000920
14
Chestnut
0.200000
1.000
1.000
14001550
14
Filbert
0.200000
1.000
1.000
14001560
14
Filbert,
oil
0.200000
1.000
1.000
14001850
14
Hickory
nut
0.200000
1.000
1.000
14002130
14
Macadamia
nut
0.200000
1.000
1.000
14002690
14
Pecan
0.200000
1.000
0.010
14002820
14
Pistachio
0.200000
1.000
1.000
14003910
14
Walnut
0.200000
1.000
0.010
Bifenazate
(
000586)
Dietary
Exposure
and
Risk
Assessment
D330587
page
14
of
15
Attachment
3:
DEEM­
FCID
 
chronic
exposure
estimates
U.
S.
Environmental
Protection
Agency
Ver.
2.00
DEEM­
FCID
Chronic
analysis
for
BIFENAZATE
(
1994­
98
data)
Residue
file
name:
C:\
Documents
and
Settings\
tbloem\
bifenazate\
tuberous
and
corm
vegetables
and
succulent
pea\
000586c.
R98
Adjustment
factor
#
2
used.
Analysis
Date
07­
27­
2006/
09:
58:
15
Residue
file
dated:
07­
14­
2006/
13:
36:
39/
8
Reference
dose
(
RfD,
Chronic)
=
.01
mg/
kg
bw/
day
COMMENT
1:
no
acute
endpoint
identified;
FQPA
SF
of
1x
==============================================================================
Total
exposure
by
population
subgroup
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
Total
Exposure
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
Population
mg/
kg
Percent
of
Subgroup
body
wt/
day
Rfd
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
­­­­­­­­­­­­­
­­­­­­­­­­­­­­­
U.
S.
Population
(
total)
0.003835
38.3%

U.
S.
Population
(
spring
season)
0.003900
39.0%
U.
S.
Population
(
summer
season)
0.003864
38.6%
U.
S.
Population
(
autumn
season)
0.003764
37.6%
U.
S.
Population
(
winter
season)
0.003815
38.2%

Northeast
region
0.003689
36.9%
Midwest
region
0.004040
40.4%
Southern
region
0.003717
37.2%
Western
region
0.003933
39.3%

Hispanics
0.003999
40.0%
Non­
hispanic
whites
0.003795
37.9%
Non­
hispanic
blacks
0.003885
38.9%
Non­
hisp/
non­
white/
non­
black
0.003956
39.6%

All
infants
(<
1
year)
0.007938
79.4%
Nursing
infants
0.002697
27.0%
Non­
nursing
infants
0.009927
99.3%
Children
1­
6
yrs
0.008684
86.8%
Children
7­
12
yrs
0.005654
56.5%

Females
13­
19
(
not
preg
or
nursing)
0.003211
32.1%
Females
20+
(
not
preg
or
nursing)
0.002622
26.2%
Females
13­
50
yrs
0.003078
30.8%
Females
13+
(
preg/
not
nursing)
0.003447
34.5%
Females
13+
(
nursing)
0.003636
36.4%

Males
13­
19
yrs
0.004181
41.8%
Males
20+
yrs
0.003160
31.6%
Seniors
55+
0.002521
25.2%

Children
1­
2
yrs
0.009386
93.9%
Children
3­
5
yrs
0.008595
85.9%
Children
6­
12
yrs
0.005942
59.4%
Youth
13­
19
yrs
0.003712
37.1%
Adults
20­
49
yrs
0.003084
30.8%
Adults
50+
yrs
0.002554
25.5%
Females
13­
49
yrs
0.002864
28.6%
Bifenazate
(
000586)
Dietary
Exposure
and
Risk
Assessment
D330587
page
15
of
15
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­