Document ID: EPA-HQ-OPP-2005-0035-0005
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2006-09-01T04:00Z

Benthiavalicarb­
Isopropyl
Dietary
Exposure
Assessment
DP
Barcode:
D322935
PC
Code:
098379
Page:
1
of
12
UNITED
STATES
ENVIRONMENTAL
PROTECTION
AGENCY
WASHINGTON,
D.
C.
20460
OFFICE
OF
PREVENTION,
PESTICIDES
AND
TOXIC
SUBSTANCES
MEMORANDUM
DATE:
3/
2/
2006
SUBJECT:
Benthiavalicarb­
Isopropyl:
Chronic
and
Cancer
Dietary
Exposure
Assessments
for
the
Section
3
Registration
Action
on
Imported
Grapes
and
Tomatoes
PC
Code:
098379
DP
Barcode:
D322935
REVIEWER:
Douglas
Dotson,
Ph.
D.,
Chemist
Registration
Action
Branch
2
Health
Effects
Division
(
7509C)

THROUGH:
Dave
Soderberg,
Chemist
Thurston
Morton,
Chemist
Dietary
Exposure
Science
Advisory
Council
Health
Effects
Division
(
7509C)

and
Michael
Doherty,
Ph.
D.,
Chemist
Richard
Loranger,
Ph.
D.,
Branch
Senior
Scientist
RAB2/
Health
Effects
Division
(
7509C)

TO:
Tamue
Gibson/
Mary
Waller,
RM
21
Fungicide
Branch
Registration
Division
(
7505C)

Executive
Summary
A
chronic
dietary
risk
assessment
was
conducted
using
the
Dietary
Exposure
Evaluation
Model
(
DEEM­
FCID,
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.
The
result
of
the
chronic
dietary
exposure
assessment
for
the
general
U.
S.
population
was
used
along
with
the
cancer
Q1*
value
to
determine
the
cancer
risk
to
the
U.
S.
population.
The
analysis
was
performed
to
support
Section
3
requests
for
tolerances
for
residues
of
benthiavalicarb­
isopropyl
(
hereafter
referred
to
as
benthiavalicarb)
on
imported
grapes
and
tomatoes.
Benthiavalicarb­
Isopropyl
Dietary
Exposure
Assessment
DP
Barcode:
D322935
PC
Code:
098379
Page:
2
of
12
Chronic
Dietary
Exposure
Results
and
Characterization
The
chronic
dietary
exposure
analysis
is
based
on
average
field
trial
values
and
estimates
of
percent
crop
imported.
Empirical
processing
factors
were
used
for
most
processed
commodities.
When
empirical
factors
were
not
available,
DEEM
(
Version
7.81)
default
processing
factors
were
used.
The
general
U.
S.
population
and
all
population
subgroups
have
risk
estimates
that
are
below
HED's
level
of
concern
(
i.
e.,
100%
of
the
chronic
population
adjusted
dose
(
cPAD)).
All
risk
estimates
are
less
than
1%
of
the
cPAD.
For
the
chronic
assessment,
all
population
subgroups
would
have
had
risk
estimates
that
were
below
HED's
level
of
concern
if
no
refinements
had
been
made
to
the
analysis,
i.
e.,
if
tolerance
level
residues
and
100%
crop
imported
assumptions
had
been
used.
It
was
necessary
to
refine
the
inputs
for
the
cancer
assessment,
though.
Those
same
refinements
were
used
for
the
chronic
analysis.

Cancer
Dietary
Exposure
Results
and
Characterization
HED's
Cancer
Assessment
Review
Committee
(
CARC)
determined
that
benthiavalicarb
is
likely
to
be
carcinogenic
to
humans
and
assigned
it
a
Q1*
value
of
0.062795
(
mg/
kg/
day)­
1.
In
an
unrefined
cancer
dietary
exposure
analysis,
the
cancer
risk
to
the
general
U.
S.
population
exceeds
HED's
level
of
concern.
As
a
result,
refinements
were
made
to
the
cancer
dietary
exposure
analysis.
The
refinements
made
are
those
discussed
above:
the
use
of
average
field
trial
values
and
estimates
of
percent
crop
imported.
With
the
use
of
these
refinements,
the
lifetime
cancer
risk
to
the
U.
S.
population
is
1.6
x
10­
6.
Although
refinements
were
made
to
the
analysis,
it
is
considered
to
be
conservative,
for
three
reasons.
First,
average
field
trial
values
from
field
trials
almost
always
exceed
the
expected
residue
levels
found
on
crops
at
the
time
of
consumption.
Second,
the
registrant
intends
to
market
benthiavalicarb
in
the
European
Union
only.
In
the
dietary
analysis,
percent
crop
imported
estimates
were
used
for
all
imports,
not
just
those
from
Europe.
Third,
it
was
assumed
that
100%
of
the
imported
crop
will
be
treated.
The
actual
percent
crop
treated
will
very
likely
be
considerably
lower
than
that.

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
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.
HED
is
generally
concerned
when
estimated
cancer
risk
exceeds
one
in
one
million
(
i.
e.,
the
risk
exceeds
1
x
10­
6).
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:
Benthiavalicarb­
Isopropyl
Dietary
Exposure
Assessment
DP
Barcode:
D322935
PC
Code:
098379
Page:
3
of
12
http://
www.
epa.
gov/
fedrgstr/
EPA­
PEST/
2000/
July/
Day­
12/
6061.
pdf
;
or
see
SOP
99.6
(
8/
20/
99).
This
dietary
exposure
analysis
is
the
first
one
performed
by
HED
for
benthiavalicarb.
Benthiavalicarb
has
no
U.
S.
registrations.

II.
Residue
Information
Residues
in
Food
HED
is
recommending
in
favor
of
the
establishment
of
tolerances
on
imported
grapes,
raisins,
and
tomatoes.
All
issues
and
data
regarding
the
tolerance
requests
are
discussed
in
the
residue
chemistry
summary
document
prepared
for
the
requests
(
D322934,
D.
Dotson,
3/
2/
2006).
The
individual
field
trial
values
used
to
calculate
the
average
values
are
given
in
Table
1,
below.
For
all
grape
commodities,
the
average
field
trial
value
was
used.
This
value
is
0.06958
ppm.
When
the
tomato
field
trials
were
performed,
they
were
performed
under
two
different
types
of
conditions.
Some
trials
were
performed
in
greenhouses
and
others
were
performed
in
outdoor
fields.
Greenhouse­
grown
tomatoes
are
meant
for
direct
exportation
without
processing.
Tomatoes
grown
on
outdoor
fields
are
the
only
tomatoes
that
will
be
processed.
As
a
result,
for
the
unprocessed
commodities
in
the
dietary
exposure
analysis,
the
average
field
trial
value
from
the
greenhouse­
grown
tomatoes
was
used.
This
value
is
0.1133
ppm.
For
processed
commodities,
however,
the
average
field
trial
value
from
the
outdoor
field
trials
was
used
along
with
the
appropriate
processing
factor.
The
average
outdoor
field
trial
value
was
0.00767
ppm.

The
registrant
performed
processing
studies
on
both
grapes
and
tomatoes.
For
grape
commodities,
processing
factors
were
determined
for
grape
juice,
wine,
and
raisins.
For
tomato
commodities,
processing
factors
were
determined
for
juice
and
puree.
Table
2
lists
the
empirical
processing
factors
used
in
the
analysis.
Concentration
factors
were
not
determined
for
tomato
paste
and
dried
tomatoes.
As
a
result,
DEEM
Version
7.81
default
processing
factors
were
used
for
these
two
commodities.

Table
1.
Benthiavalicarb
Field
Trial
Values
Used
to
Establish
Average
Values
Grapes
(
ppm)
Grapes
Continued
(
ppm)
Grapes
Continued
(
ppm)
Tomatoes
(
Greenhouse)
(
ppm)
Tomatoes
(
Outdoor
Field
Trials)
(
ppm)

0.023
0.039
0.028
0.116
0.015
0.051
0.077
0.036
0.041
0.004
0.091
0.093
0.028
0.095
0.004
0.125
0.041
0.032
0.141
0.084
0.161
0.057
0.124
Benthiavalicarb­
Isopropyl
Dietary
Exposure
Assessment
DP
Barcode:
D322935
PC
Code:
098379
Page:
4
of
12
Table
1.
Benthiavalicarb
Field
Trial
Values
Used
to
Establish
Average
Values
Grapes
(
ppm)
Grapes
Continued
(
ppm)
Grapes
Continued
(
ppm)
Tomatoes
(
Greenhouse)
(
ppm)
Tomatoes
(
Outdoor
Field
Trials)
(
ppm)

0.043
0.149
0.069
0.268
0.042
0.153
0.020
0.048
0.039
0.269
0.035
0.044
0.077
0.175
0.122
0.230
0.040
0.039
0.082
0.222
0.024
0.038
0.080
0.066
0.044
0.051
0.114
0.077
0.071
0.072
0.104
0.067
0.112
0.083
0.028
0.047
0.110
0.012
0.034
0.032
0.032
0.006
0.082
0.043
Average
Field
Trial
Value
0.0698
0.1133
0.00767
Table
2.
Processing
Factors
Used
in
Analysis
Adj.
#
1*
Source
of
Processing
Factor
Grape
Juice
0.470
Processing
Study
Grape,
Wine
0.975
Processing
Study
Raisins
3.67
Processing
Study
Tomato
Juice
0.49
Processing
Study
Tomato
Puree
1.16
Processing
Study
Tomato
Paste
5.4
DEEM
Version
7.81
Default
Benthiavalicarb­
Isopropyl
Dietary
Exposure
Assessment
DP
Barcode:
D322935
PC
Code:
098379
Page:
5
of
12
Table
2.
Processing
Factors
Used
in
Analysis
Adj.
#
1*
Source
of
Processing
Factor
Dried
Tomatoes
14.3
DEEM
Version
7.81
Default
*
Adj.
#
1:
Adjustment
Factor
#
1.
The
actual
processing
factor
used
in
the
processing
factor
column
in
the
residue
input
file
(
Attachment
1).
Benthiavalicarb­
Isopropyl
Dietary
Exposure
Assessment
DP
Barcode:
D322935
PC
Code:
098379
Page:
6
of
12
Residues
in
Water
The
tolerances
being
requested
are
for
imported
commodities
only.
As
a
result,
residues
in
water
are
not
being
considered
in
this
analysis.

III.
Percent
Crop
Imported
As
the
unrefined
cancer
risk
estimate
to
the
general
U.
S.
population
was
above
HED's
level
of
concern,
HED
used
estimates
of
percent
crop
imported
to
refine
the
analysis.
It
is
the
intention
of
the
registrant
to
market
benthiavalicarb
in
Europe
only.
When
a
tolerance
is
granted,
however,
the
Agency
does
not
restrict
the
use
of
the
registered
chemical
to
any
one
part
of
the
world.
As
a
result,
at
some
point
in
the
future,
benthiavalicarb
may
be
used
outside
of
Europe.
For
this
reason,
worldwide
percent
crop
imported
estimates
were
used
in
the
analysis
rather
than
estimates
of
percent
crop
imported
from
Europe
alone.

In
order
to
determine
the
percent
crop
imported
for
individual
grape
and
tomato
commodities,
data
are
needed
for
the
following
three
quantities:
(
1)
domestic
production,
(
2)
the
quantity
exported,
and
(
3)
the
quantity
imported.
These
data
were
not
available
for
all
commodities
in
the
analysis.
For
grapes,
these
data
were
available
for
grape
juice
and
raisins
only.
Percent
imported
data
for
grapes
and
wine
are
directly
available
from
the
USDA
Economic
Research
Service
(
ERS),
however.
For
unprocessed
tomatoes,
the
three
quantities
listed
above
are
available.
Data
were
not
used
for
the
individual
tomato
commodities
because
a
significant
amount
of
processing
occurs
after
importation.
Data
are
available
for
domestic
tomato
production
utilized
for
processing
and
processed
tomato
imports.
The
import
data
include
canned
tomatoes,
a
significant
fraction
of
which
is
utilized
for
processing
in
the
U.
S.
Dividing
the
imported
by
the
total
yields
a
value
of
5.84%
imported.
The
USDA
ERS,
Vegetable
and
Melons
Outlook
(
VGS­
308)
of
April
21,
2005
states
the
following:
"
According
to
ERS
estimates,
nearly
6
percent
of
the
tomato
products
consumed
by
Americans
in
2004
were
imported."
The
value
of
5.84%
was
used
for
paste,
puree,
and
juice.
A
value
of
100%
was
used
for
dried
tomatoes.

The
data
for
grape
commodities
were
provided
by
BEAD
(
electronic
communication,
D.
Donaldson,
2/
1/
2006).
Data
for
2002
and
2003
were
used.
USDA
ERS
data
from
2004
were
used
for
tomatoes.
Table
3
gives
the
numbers
of
metric
tons
of
grapes
and
tomatoes
imported
as
well
as
the
total
numbers
of
metric
tons
utilized.
The
ratio
of
the
weights
of
the
imports
to
the
total
weights
utilized
is
the
fraction
imported.
As
stated
above,
individual
data
for
domestic
production,
quantity
exported,
and
quantity
imported
were
not
available
for
grapes
and
wine.
Benthiavalicarb­
Isopropyl
Dietary
Exposure
Assessment
DP
Barcode:
D322935
PC
Code:
098379
Page:
7
of
12
Table
3.
Data
Used
to
Determine
Percent
Crop
Imported
Commodity
Domestic
Utilized
(
metric
tons)
Quantity
Imported
(
metric
tons)
Total
Utilized
(
metric
tons)
Fraction
Imported
Tomatoes
1,636,372
931,791
2,568,163
0.363
Processed
Tomato
Commodities
9,387,755
581,731
9,969,486
0.0584
Grapes
­
­
­
0.45
Grape
Juice
285,130
223,382
508,512
0.439
Wine
­
­
­
0.23
Raisins
889,666
106,135
995,801
0.107
IV.
DEEM­
FCID
 
Program
and
Consumption
Information
A
benthiavalicarb
chronic
dietary
exposure
assessment
was
conducted
using
the
Dietary
Exposure
Evaluation
Model
software
with
the
Food
Commodity
Intake
Database
(
DEEM­
FCID
 
,
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,
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.
The
resulting
residue
consumption
estimate
for
each
food/
food
form
is
summed
with
the
residue
consumption
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.

When
the
Q1*
approach
is
being
used
for
cancer
assessment,
the
chronic
dietary
exposure
Benthiavalicarb­
Isopropyl
Dietary
Exposure
Assessment
DP
Barcode:
D322935
PC
Code:
098379
Page:
8
of
12
estimate
of
the
general
U.
S.
population
is
multiplied
by
the
Q1*
value.
As
cancer
results
from
lifetime
exposure
to
a
chemical,
the
cancer
risk
is
estimated
for
the
general
U.
S.
population
only.
V.
Toxicological
Information
The
Health
Effects
Division
has
evaluated
the
toxicology
database
for
benthiavalicarb.
The
findings
of
the
risk
assessment
team
relative
to
dietary
exposure
are
summarized
in
Table
4.
No
appropriate
endpoint
was
identified
for
assessing
acute
exposures.
The
FQPA
Safety
Factor
was
reduced
to
1x
for
all
population
subgroups.
HED's
Cancer
Assessment
Review
Committee
(
CARC)
determined
that
benthiavalicarb
is
likely
to
be
carcinogenic
to
humans
(
Memo,
TXR
No.
0053803,
10/
18/
2005)
and
assigned
it
a
Q1*
value
of
0.062795
(
mg/
kg/
day)­
1(
Memo,
TXR
No.
0053755,
9/
26/
2005).

Table
4.
Summary
of
Toxicological
Doses
and
Endpoints
for
Use
in
Human
Health
Dietary
Risk
Assessment
for
Benthiavalicarb
Exposure
Scenario
Dose
Used
in
Risk
Assessment,
UF
Special
FQPA
SF*
and
Level
of
Concern
for
Risk
Assessment
Study
and
Toxicological
Effects
Acute
Dietary
NOAEL
=
N/
S
UF
=
N/
A
Acute
RfD
=
N/
A
FQPA
SF
=
N/
A
None
of
the
study
endpoints
were
the
result
of
one
or
two
exposures
to
benthiavalicarb;
therefore,
an
acute
endpoint
was
not
selected
for
dietary
exposure.

Chronic
Dietary
(
All
populations)
NOAEL
=
9.9
mg/
kg/
day
UF
=
100
Chronic
RfD
=
0.099
mg/
kg/
day
FQPA
SF
=
1x
cPAD
=
chronic
RfD
FQPA
SF
=
0.099
mg/
kg/
day
Chronic
oral
toxicity
in
rats.

LOAEL
=
249.6
mg/
kg/
day
based
on
nephrotoxicity
and
hepatotoxicity.

Cancer
(
oral,
dermal,
inhalation)
Likely
to
be
carcinogenic
to
humans
Q1*
=
0.062795
(
mg/
kg/
day)­
1
Based
on
increases
in
male
mouse
liver
combined
adenomas
and/
or
carcinomas
and/
or
blastomas.

VI.
Results/
Discussion
As
stated
above,
for
chronic
assessments,
HED
is
concerned
when
dietary
risk
exceeds
100%
of
the
cPAD.
The
DEEM­
FCID
 
analyses
estimate
the
dietary
exposure
of
the
U.
S.
population
and
various
population
subgroups.
The
results
reported
in
Table
5
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.

The
analyses
summarized
in
Table
5
are
based
on
average
field
trial
values.
Both
empirical
and
default
processing
factors
were
used.
Finally,
the
percentages
of
grapes
and
tomatoes
imported
Benthiavalicarb­
Isopropyl
Dietary
Exposure
Assessment
DP
Barcode:
D322935
PC
Code:
098379
Page:
9
of
12
from
all
other
countries
were
also
used
to
modify
residue
values.
The
chronic
risk
estimates
for
the
general
U.
S.
population
and
all
population
subgroups
are
well
below
HED's
level
of
concern.
All
population
subgroups
utilize
<
1.0%
of
the
cPAD.
The
cancer
risk
to
the
general
U.
S.
population
is
1.6
x
10­
6.
Table
6
provides
a
list
of
the
commodities
that
make
the
greatest
contributions
to
the
risk.
These
commodities,
in
order
of
decreasing
contribution
to
the
total
cancer
risk
are:
tomatoes,
grape
juice,
grapes,
wine,
and
raisins.
Tomatoes
alone
contribute
61%
of
the
risk.
Grape
juice,
grapes,
wine,
and
raisins
contribute
14%,
12%,
8%,
and
3%,
respectively,
for
a
total
of
37%.

Table
5.
Summary
of
Dietary
Exposure
and
Risk
for
Benthiavalicarb
DEEM:
Chronic
Analysis
Population
Subgroup
Acute
Analysis
Dietary
Exposure
(
mg/
kg/
day)
%
cPAD
Cancer
Analysis
General
U.
S.
Population
0.000026
<
1.0
1.61
x
10­
6
All
Infants
(<
1
year
old)
0.000017
<
1.0
Children
1­
2
years
old
0.000071
<
1.0
Children
3­
5
years
old
0.000053
<
1.0
Children
6­
12
years
old
0.000030
<
1.0
Youth
13­
19
years
old
0.000019
<
1.0
Adults
20­
49
years
old
0.000022
<
1.0
Adults
50+
years
old
0.000023
<
1.0
Females
13­
49
years
old
Not
Applicable:
No
Acute
Dietary
Endpoint
0.000021
<
1.0
N/
A:
Cancer
risk
is
determined
for
the
general
U.
S.
population
only
Table
6.
Critical
Commodity
Contribution
to
Cancer
Risk
Commodity
Exposure
Estimate
Contribution
to
Risk
Percentage
Contribution
to
Risk
Tomato
0.0000157
0.99
x
10­
6
61%

Grape
Juice
0.0000036
0.23
x
10­
6
14%

Grapes
0.0000031
0.19
x
10­
6
12%

Wine
0.0000020
0.13
x
10­
6
8%

Raisins
0.0000007
0.04
x
10­
6
3%
Benthiavalicarb­
Isopropyl
Dietary
Exposure
Assessment
DP
Barcode:
D322935
PC
Code:
098379
Page:
10
of
12
Table
6.
Critical
Commodity
Contribution
to
Cancer
Risk
Commodity
Exposure
Estimate
Contribution
to
Risk
Percentage
Contribution
to
Risk
Total
for
top
5
commodities
0.0000251
1.58
x
10­
6
98%

VII.
Characterization
of
Inputs/
Outputs
Although
refinements
were
made
to
the
analysis,
it
is
still
considered
to
be
conservative.
First,
average
field
trial
values
from
field
trials
almost
always
exceed
the
expected
residue
levels
found
on
crops
at
the
time
of
consumption.
When
field
trials
are
performed,
the
maximum
allowable
application
rate
is
used
and
crops
are
harvested
at
the
minimum
PHI.
Samples
are
stored
frozen
until
analysis
to
ensure
minimal
degradation
of
residues.
In
actual
practice,
however,
growers
will
not
usually
use
the
maximum
application
rates
for
economic
reasons.
In
addition,
most
crops
are
not
harvested
and
immediately
stored
frozen.
From
previous
dietary
exposure
analyses,
HED
has
noted
that
monitoring
data
are
often
one
to
two
orders
of
magnitude
lower
than
field
trial
data.
The
second
reason
this
analysis
is
considered
to
be
conservative
is
because
the
registrant
is
planning
on
marketing
benthiavalicarb
in
Europe
only.
In
the
dietary
analysis,
percent
crop
imported
estimates
were
used
for
all
imports,
not
just
those
from
Europe.
The
third
reason
this
analysis
is
considered
to
be
conservative
is
that
HED
assumed
that
100%
of
the
imported
crop
will
be
treated.
The
actual
percent
crop
treated
will
very
likely
be
considerably
lower
than
that.
For
these
reasons,
HED
is
confident
that
this
analysis
does
not
underestimate
risk
to
the
general
U.
S.
population
or
any
population
subgroup.

VIII.
Conclusions
Based
on
conservative
assumptions,
chronic
dietary
risk
estimates
to
benthiavalicarb
are
below
HED's
level
of
concern
for
the
general
U.
S.
population
and
all
population
subgroups,
including
those
comprised
of
infants
and
children.
The
estimated
cancer
risk
to
the
general
U.
S.
population
is
1.6
x
10­
6.
If
monitoring
data
were
available
for
benthiavalicarb
on
imported
grapes
and
tomatoes,
and
if
benthiavalicarb
is
only
used
in
Europe,
as
is
the
current
intention,
HED
is
confident
that
the
use
of
benthiavalicarb
on
grapes
and
tomatoes
will
present
a
cancer
risk
to
the
general
U.
S.
population
of
less
than
one
in
one
million.

VIII.
List
of
Attachments
Benthiavalicarb­
Isopropyl
Dietary
Exposure
Assessment
DP
Barcode:
D322935
PC
Code:
098379
Page:
11
of
12
Attachment
1:
Residue
Input
File
for
Chronic
and
Cancer
Analyses
Attachment
2:
Results
of
Chronic
Dietary
Exposure
Analysis
Attachment
3:
Results
of
Cancer
Dietary
Exposure
Analysis
cc:
D.
Dotson
Benthiavalicarb­
Isopropyl
Dietary
Exposure
Assessment
DP
Barcode:
D322935
PC
Code:
098379
Page:
12
of
12
Attachment
1:
Residue
Input
File
for
Benthiavalicarb­
Isopropyl
Filename:
C:\
DEEMFCID\
Benthia\
Benthia6.
R98
Chemical:
Benthiavalicarb­
Isopropyl
NOAEL
(
Chronic):
9.9
mg/
kg
bw/
day
PAD
(
Chronic):
0.099
mg/
kg
bw/
day
Q*=
0.0628
Date
created/
last
modified:
02­
01­
2006/
13:
13:
21/
8
Program
ver.
2.03
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
EPA
Crop
Def
Res
Adj.
Factors
Comment
Code
Grp
Commodity
Name
(
ppm)
#
1
#
2
­­­­­­­­
­­­­
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
­­­­­­­­­­
­­­­­­
­­­­­­
­­­­­­­
08003740
8
Tomatillo
0.113300
1.000
0.363
08003750
8
Tomato
0.113300
1.000
0.363
08003751
8
Tomato­
babyfood
0.113300
1.000
0.363
08003760
8
Tomato,
paste
0.007670
5.400
0.058
08003761
8
Tomato,
paste­
babyfood
0.007670
5.400
0.058
08003770
8
Tomato,
puree
0.007670
1.160
0.058
08003771
8
Tomato,
puree­
babyfood
0.007670
1.160
0.058
08003780
8
Tomato,
dried
0.007670
14.300
1.000
08003781
8
Tomato,
dried­
babyfood
0.007670
14.300
1.000
08003790
8
Tomato,
juice
0.007670
0.490
0.058
95001750
O
Grape
0.069580
1.000
0.450
95001760
O
Grape,
juice
0.069580
0.470
0.439
95001761
O
Grape,
juice­
babyfood
0.069580
0.470
0.439
95001770
O
Grape,
leaves
0.069580
1.000
1.000
95001780
O
Grape,
raisin
0.069580
3.670
0.107
95001790
O
Grape,
wine
and
sherry
0.069580
0.975
0.230
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
Benthiavalicarb­
Isopropyl
Dietary
Exposure
Assessment
DP
Barcode:
D322935
PC
Code:
098379
Page:
13
of
12
Attachment
2:
Results
of
Chronic
Dietary
Exposure
Analysis
DEEM­
FCID
Version
2.03,
1994­
96
data
with
1998
Supplemental
Children's
Survey
Residue
file
name:
C:\
DEEMFCID\
Benthia\
Benthia6.
R98
Analysis
Date
02­
01­
2006/
13:
20:
31
Residue
file
dated:
02­
01­
2006/
13:
13:
21/
8
Population
Adjusted
Dose
(
PAD,
Chronic)
=
0.099
mg/
kg
bw/
day
Adjustment
factor
#
2
used.

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

Total
Exposure
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
Population
mg/
kg
Percent
of
Subgroup
body
wt/
day
cPAD
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
­­­­­­­­­­­­­
­­­­­­­­­­­­­­­
U.
S.
Population
(
total)
0.000026
0.0%

U.
S.
Population
(
spring
season)
0.000024
0.0%
U.
S.
Population
(
summer
season)
0.000030
0.0%
U.
S.
Population
(
autumn
season)
0.000025
0.0%
U.
S.
Population
(
winter
season)
0.000023
0.0%

Northeast
region
0.000027
0.0%
Midwest
region
0.000025
0.0%
Southern
region
0.000023
0.0%
Western
region
0.000030
0.0%

Hispanics
0.000032
0.0%
Non­
hispanic
whites
0.000026
0.0%
Non­
hispanic
blacks
0.000019
0.0%
Non­
hisp/
non­
white/
non­
black
0.000027
0.0%

All
infants
(<
1
year)
0.000017
0.0%
Nursing
infants
0.000007
0.0%
Non­
nursing
infants
0.000020
0.0%
Children
1­
6
yrs
0.000056
0.1%
Children
7­
12
yrs
0.000029
0.0%

Females
13­
19
(
not
preg
or
nursing)
0.000018
0.0%
Females
20+
(
not
preg
or
nursing)
0.000023
0.0%
Females
13­
50
yrs
0.000024
0.0%
Females
13+
(
preg/
not
nursing)
0.000019
0.0%
Females
13+
(
nursing)
0.000026
0.0%

Males
13­
19
yrs
0.000019
0.0%
Males
20+
yrs
0.000022
0.0%
Seniors
55+
0.000023
0.0%

Children
1­
2
yrs
0.000071
0.1%
Children
3­
5
yrs
0.000053
0.1%
Children
6­
12
yrs
0.000030
0.0%
Youth
13­
19
yrs
0.000019
0.0%
Adults
20­
49
yrs
0.000022
0.0%
Adults
50+
yrs
0.000023
0.0%
Females
13­
49
yrs
0.000021
0.0%

­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
Benthiavalicarb­
Isopropyl
Dietary
Exposure
Assessment
DP
Barcode:
D322935
PC
Code:
098379
Page:
14
of
12
Attachment
3:
Results
of
Cancer
Dietary
Exposure
Analysis
DEEM­
FCID
Version
2.03,
1994­
98
data
Q*
=
0.062795
Residue
file
name:
C:\
DEEMFCID\
Benthia\
Benthia6.
R98
Analysis
Date
02­
01­
2006/
13:
14:
40
Residue
file
dated:
02­
01­
2006/
13:
13:
21/
8
Adjustment
factor
#
2
used.

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

Total
Exposure
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
Population
mg/
kg
Lifetime
risk
Subgroup
body
wt/
day
(
Q*=
.0628)
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
­­­­­­­­­­­­­
­­­­­­­­­­­­­
U.
S.
Population
(
total)
0.000026
1.61
E­
06
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­