Document ID: EPA-HQ-OPP-2005-0537-0006
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2006-08-30T04:00Z

Ethofumesate
Dietary
Exposure
Assessment
DP
Barcode:
DP296947
PC
Code:
110601
Page:
1
of
19
UNITED
STATES
ENVIRONMENTAL
PROTECTION
AGENCY
WASHINGTON,
D.
C.
20460
OFFICE
OF
PREVENTION,
PESTICIDES
AND
TOXIC
SUBSTANCES
MEMORANDUM
DATE:
9/
21/
2004
SUBJECT:
Ethofumesate.
Acute
and
Chronic
Dietary
Exposure
Assessment
for
the
Reregistration
Eligibility
Decision.

PC
Code:
110601
DP
Barcode:
DP296947
REVIEWER:
José
J.
Morales,
Chemist
Reregistration
Branch
3
Health
Effects
Division
(
7509C)

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

and
Alberto
Protzel,
Branch
Senior
Scientist
Toxicology
Branch
Health
Effects
Division
(
7509C)

TO:
Nancy
McCarrol,
Risk
Assessor
Toxicology
Branch
Health
Effects
Division
(
7509C)
Ethofumesate
Dietary
Exposure
Assessment
DP
Barcode:
DP296947
PC
Code:
110601
Page:
2
of
19
Executive
Summary
An
acute
and
chronic
dietary
(
food+
water)
risk
assessment
was
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.
The
analysis
was
performed
to
support
the
reregistration
eligibility
decision.
The
acute
and
chronic
dietary
exposure/
risk
analyses
were
conducted
using
tolerance
values,
default
processing
factors,
processing
factor
from
sugar
beet
processing
studies,
100%
crop
treated
for
all
commodities,
and
a
point
estimate
value,
the
maximum
concentration
for
acute
dietary
risk
assessment,
and
the
average
concentration
for
chronic
dietary
risk
assessment,
from
PRZM/
EXAMS
for
drinking
water
contribution
to
exposure.
Based
in
this
Tier
1
(
unrefined)
assessment,
the
team
selected
the
95th
percentile
of
exposure
to
estimate
acute
dietary
risk
from
food
and
water.
No
monitoring
data
are
available
for
ethofumesate.

Acute
Dietary
Exposure
Results
and
Characterization
A
conservative
acute
dietary
(
food
+
water)
assessment
was
performed
using
DEEMFCIDTM
Tolerance
level
residues
and
100%
crop
treated
were
used
in
the
assessment.
This
assessment
concludes
that
for
all
supported
commodities,
the
acute
dietary
exposure
estimate
is
below
HED's
level
of
concern
for
females
13­
49
years
of
age
(
the
only
population
subgroup
of
concern
toxicologically
identified
at
this
time)
at
5
%
of
the
aPAD
at
the
95th
percentile.

Chronic
Dietary
Exposure
Results
and
Characterization
A
conservative
chronic
dietary
(
food
+
water)
assessment
was
performed
using
DEEMFCIDTM
Tolerance
level
residues
and
100%
crop
treated
were
used
in
the
assessment.
Dietary
risk
estimates
are
provided
for
the
general
U.
S.
population
and
various
population
subgroups.
This
assessment
concludes
that
for
all
supported
commodities,
the
chronic
dietary
exposure
estimates
are
below
HED's
level
of
concern
for
all
population
subgroups
at
<
1%
of
the
cPAD.
Ethofumesate
Dietary
Exposure
Assessment
DP
Barcode:
DP296947
PC
Code:
110601
Page:
3
of
19
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
Food
Quality
Protection
Act
(
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:
http://
www.
epa.
gov/
fedrgstr/
EPA­
PEST/
2000/
July/
Day­
12/
6061.
pdf;
or
see
SOP
99.6
(
8/
20/
99).

II.
Residue
Information
Ethofumesate
Use:

Ethofumesate
tolerances
are
currently
established
for
the
combined
residues
of
ethofumesate
and
its
metabolites
NC
8493
and
NC
9607,
both
calculated
as
parent,
in/
on
plant
and
animal
commodities
[
40
CFR
§
180.345(
a)].
Tolerances
for
plant
commodities
range
from
0.1
ppm
in/
on
sugar
beet
roots
to
1.0
ppm
in/
on
sugar
beet
tops
and
grass
straw.
Tolerances
on
animal
commodities
are
set
at
0.05
ppm.

Residue
Data
used
for
Acute
and
Chronic
Assessments
Residue
Data
for
crops
The
acute
and
chronic
dietary
exposure/
risk
analyses
were
conducted
using
tolerance
level
residues,
DEEM
 
(
ver
7.76)
default
processing
factors
for
dried
beef,
processing
factors
from
sugar
beet
processing
studies
and
100%
crop
treated.

Based
on
the
use
of
ethofumesate
on
sugar
beets,
there
is
the
potential
for
exposure
of
livestock
to
ethofumesate
residues
in
their
diet.
As
there
are
currently
no
uses
on
crops
having
regulated
poultry
or
swine
feed
items,
feeding
studies
and
tolerances
for
poultry
and
swine
commodities
are
presently
not
required.
The
submitted
residue
data
suggest
that
residues
of
ethofumesate
and
its
metabolites
of
concern
(
NC
8493,
NC
9607
and
NC
20654)
are
unlikely
to
be
quantifiable
($
0.01
ppm)
in
milk
or
milk
products
derive
from
cows
exposed
to
ethofumesate
residues
at
up
to
10x
the
MTDB
for
dairy
cattle.
Therefore,
tolerances
for
ethofumesate
residues
in
milk
could
Ethofumesate
Dietary
Exposure
Assessment
DP
Barcode:
DP296947
PC
Code:
110601
Page:
4
of
19
be
considered
to
be
a
180.6(
a)(
3)
[
i.
e.,
there
is
no
reasonable
expectation
of
finite
residues
in
ruminant
commodities].

In
an
adequate
sugar
beet
processing
study
conducted
in
1993,
ethofumesate
(
4
lb/
gal
FlC)
was
applied
to
separate
plots
as
a
single
preplant
broadcast
application
at
7.5
or
11.2
lb
a.
i./
A
(
1.9
and
2.8x
maximum
seasonal
rate).
Sugar
beet
samples
were
collected
at
149
days
after
application,
and
subsamples
from
the
11.2
lb
a.
i./
A
treatment
were
processed
into
cossettes,
dried
pulp,
molasses,
and
refined
sugar
using
simulated
commercial
procedures.

Combined
residues
of
ethofumesate,
NC
9607,
and
NC
8493
(
expressed
in
parent
equivalents)
were
0.135­
0.167
ppm
in/
on
four
sugar
beet
root
(
2.8x
rate)
subsamples
and
averaged
0.157
ppm.
Average
combined
residues
from
the
processed
fractions
were
0.301
ppm
for
molasses
and
0.081
ppm
for
cossettes,
dried
pulp,
and
refined
sugar.
The
processing
factors
for
combined
ethofumesate
residues
were
1.9x
in
molasses
and
0.5x
in
sugar,
dried
pulp,
and
cossettes.

Based
on
the
1.9x
processing
factor
for
molasses
and
the
0.5x
processing
factor
for
refined
sugar,
and
HAFT
residues
of
0.25
ppm
in
roots
from
the
field
trials,
the
maximum
expected
combined
residues
in
molasses
would
be
0.48
ppm
and
0.125
ppm
in
refined
sugar.

Table
1:
Established
and
Reassessed
Tolerances
for
Ethofumesate
Commodity
Current
Tolerance
(
ppm)
Tolerance
Reassessment
(
ppm)
Comment
Tolerances
Listed
Under
40
CFR
§
180.345(
a):

Beet,
sugar,
roots
0.1
0.3
Beet,
sugar,
tops
1.0
4.0
Residue
data
indicate
that
tolerances
should
be
increased.

Grass,
straw
1.0
Revoke
The
use
of
ethofumesate
on
grass
is
classified
as
a
nonfood
feed
use.

Sugar
beet
molasses
0.5
0.5
Based
on
HAFT
residues
of
0.25
ppm
and
the
1.9x
processing
factor,
maximum
expected
residues
are
0.48
ppm.
Beet,
sugar,
molasses
Ethofumesate
Dietary
Exposure
Assessment
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DP296947
PC
Code:
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Page:
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19
Commodity
Current
Tolerance
(
ppm)
Tolerance
Reassessment
(
ppm)
Comment
Cattle,
fat
0.05
TBD
1
With
respect
to
residues
in
tissues,
the
existing
cattle
feeding
study
is
inadequate
as
residues
of
a
major
animal
metabolite
(
NC
20654)
were
not
determined.
A
new
cattle
feeding
study
is
required.

Cattle,
meat
0.05
TBD
Cattle,
meat
byproducts
0.05
TBD
Goat,
fat
0.05
TBD
Goat,
meat
0.05
TBD
Goat,
meat
byproducts
0.05
TBD
Hog,
fat
0.05
Hog,
meat
0.05
Hog,
meat
byproducts
0.05
Revoke
There
are
no
regulated
swine
feed
items
associated
ethofumesate
uses;
therefore,
tolerances
for
hog
commodities
should
be
revoked.

Horse,
fat
0.05
TBD
See
note
above
under
cattle.

Horse,
meat
0.05
TBD
See
note
above
under
cattle.

Horse,
meat
byproducts
0.05
TBD
See
note
above
under
cattle.

Milk
None
 
The
existing
cattle
feeding
study
suggests
that
residues
of
ethofumesate
and
its
metabolites
of
concern
(
NC
8493,
NC
9607
and
NC
20654)
are
unlikely
to
be
quantifiable
($
0.01
ppm)
in
milk
or
milk
products
derive
from
cows
exposed
to
ethofumesate
residues
at
up
to
10x
the
MTDB
for
dairy
cattle.
Therefore,
tolerances
for
ethofumesate
residues
in
milk
are
unlikely
to
be
necessary
and
could
be
considered
to
be
a
180.6(
a)(
3)
[
i.
e.,
there
is
no
reasonable
expectation
of
finite
residues
in
ruminant
commodities].
Ethofumesate
Dietary
Exposure
Assessment
DP
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DP296947
PC
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Sheep,
fat
0.05
TBD
See
note
above
under
cattle.

Sheep,
meat
0.05
TBD
See
note
above
under
cattle.

Sheep,
meat
byproducts
0.05
TBD
See
note
above
under
cattle.
Ethofumesate
Dietary
Exposure
Assessment
DP
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DP296947
PC
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Page:
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Tolerances
to
Be
Proposed
under
40
CFR
180.345(
a):

Beet,
garden,
root
None
0.5
Beet,
garden,
tops
None
5.0
Residue
data
support
a
general
registration
Sugar
Beet
refined
sugar
None
0.2
Tolerances
to
Be
Proposed
under
40
CFR
180.345(
c):

Carrot,
root
None
7.0
Residue
data
support
a
regional
registration
restricted
to
WA
State
1
TBD
=
To
be
determined.

Drinking
Water
Data
The
values
used
in
the
dietary
risk
assessment
were
provided
by
the
Environmental
Fate
and
Effects
Division
(
EFED)
in
the
following
memo:
Ehtofumesate
 
Drinking
Water
Assessment
for
the
Health
Effects
Division
(
HED)
Reregistration
Eligibility
Decision
Document,
memo
from
Mark
Corbin
to
Nancy
McCarrol,
6/
9/
04,
D296949.
Water
residues
were
incorporated
in
the
DEEM­
FCID
 
into
the
food
categories
"
water,
direct,
all
sources"
and
"
water,
indirect,
all
sources".

Based
on
modeling
results,
the
maximum
estimated
surface
water­
derived
drinking
water
concentrations
for
the
use
of
ethofumesate
is
203.1
Fg/
L
(
used
for
the
acute
analysis)
for
the
IR­
4
request
using
the
Florida
vegetable
scenario,
while
the
next
highest
predicted
concentration
was
134
Fg/
L
using
the
Florida
turf
scenario,
while
the
maximum
peak
concentration
from
use
of
ethofumesate
on
sugar
beets
is
predicted
to
be
99.2
Fg/
L
for
the
Minnesota
scenario.
The
maximum
1
in
10
year
annual
average
concentrations
are
39.6
Fg/
l
(
used
for
the
chronic
analysis)
for
the
Florida
turf
scenario,
and
26
Fg/
L
for
the
30
year
annual
mean
concentration
for
the
Minnesota
sugar
beet
scenario.

III.
DEEM­
FCID
 
Program
and
Consumption
Information
Ethofumesate
Dietary
Exposure
Assessment
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19
Acute
and
chronic
dietary
exposure
assessments
were
conducted
for
ethofumesate
using
DEEMFCID
 
,
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
assessments,
consumption
data
are
averaged
for
the
entire
U.
S.
population
and
within
population
subgroups,
but
for
acute
exposure
assessment
are
retained
as
individual
consumption
events.
Based
on
analysis
of
the
1994­
96,
98
CSFII
consumption
data,
which
took
into
account
dietary
patterns
and
survey
respondents,
HED
concluded
that
it
is
most
appropriate
to
report
risk
for
the
following
population
subgroups:
the
general
U.
S.
population,
all
infants
(<
1
year
old),
children
1­
2,
children
3­
5,
children
6­
12,
youth
13­
19,
adults
20­
49,
females
13­
49,
and
adults
50+
years
old.

For
chronic
dietary
exposure
assessment,
an
estimate
of
the
residue
level
in
each
food
or
foodform
(
e.
g.,
orange
or
orange
juice)
on
the
food
commodity
residue
list
is
multiplied
by
the
average
daily
consumption
estimate
for
that
food/
food
form
to
produce
a
residue
intake
estimate.
The
resulting
residue
intake
estimate
for
each
food/
food
form
is
summed
with
the
residue
intake
estimates
for
all
other
food/
food
forms
on
the
commodity
residue
list
to
arrive
at
the
total
average
estimated
exposure.
Exposure
is
expressed
in
mg/
kg
body
weight/
day
and
as
a
percent
of
the
cPAD.
This
procedure
is
performed
for
each
population
subgroup.

IV.
Toxicological
Information
On
January
27,
2004,
the
Health
Effects
Division
(
HED)
Hazard
Identification
Assessment
Review
Committee
(
HIARC)
reviewed
the
recommendations
of
the
toxicology
reviewers
for
ethofumesate
with
regard
to
the
acute
and
chronic
Reference
Doses
(
RfDs)
and
the
toxicological
endpoint
selection
for
use
as
appropriate
in
occupational
and
residential
exposure
risk
assessments.
The
potential
for
increased
susceptibility
of
infants
and
children
from
exposure
to
ethofumesate
was
also
evaluated
as
required
by
the
Food
Quality
Protection
Act
(
FQPA)
of
1996
according
to
the
2002
Office
of
Pesticide
Programs
(
OPP)
10X
Guideline
Document.
Results
are
summarized
in
the
Table
below.
Ethofumesate
Dietary
Exposure
Assessment
DP
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DP296947
PC
Code:
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9
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19
Ethofumesate
Dietary
Exposure
Assessment
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Page:
10
of
19
Table
2.
Summary
of
Toxicological
Dose
and
Endpoints
for
Ethofumesate
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)
Developmental
NOAEL
=
30
mg/
kg/
day
UF
=
100
Acute
RfD
=
0.30
mg/
kg/
day
FQPA
SF
=
1X
aPAD
=
acute
RfD
FQPA
SF
=
0.30
mg/
kg/
day
Developmental
toxicity
study
in
rabbits
MRIDs
00156606,
40263701,
41652501
Developmental
LOAEL
=
300
mg/
kg/
day
based
on
increased
resorptions,
post­
implantation
loss
and
incomplete
ossification
of
the
vertebral
arches.

Acute
Dietary
(
General
population
including
infants
and
children)
No
appropriate
acute
endpoint
identified
Chronic
Dietary
(
Females
13­
49
years
of
age)
Developmental
NOAEL
=
30
mg/
kg/
day
UF
=
100
Chronic
RfD
=
0.30
mg/
kg/
day
FQPA
SF
=
1X
cPAD
=
chronic
RfD
FQPA
SF
=
0.30
mg/
kg/
day
Developmental
toxicity
study
in
rabbits
MRIDs
00156606,
40263701,
41652501
Developmental
LOAEL
=
300
mg/
kg/
day
based
on
increased
resorptions,
post­
implantation
loss
and
incomplete
ossification
of
the
vertebral
arches.

Chronic
Dietary
(
General
population
including
infants
and
children)
NOAEL=
127
mg/
kg/
day
UF
=
100
Chronic
RfD
=
1.3
mg/
kg/
day
FQPA
SF
=
1X
cPAD
=
chronic
RfD
FQPA
SF
=
1.3
mg/
kg/
day
Chronic
oral
toxicity/
carcinogenicity
study
in
rat
MRIDs
44093603,
44093604
LOAEL
=
469
mg/
kg/
day
based
on
decreased
body
weight
gain
in
females.
Ethofumesate
Dietary
Exposure
Assessment
DP
Barcode:
DP296947
PC
Code:
110601
Page:
11
of
19
Exposure
Scenario
Dose
Used
in
Risk
Assessment,
UF
Special
FQPA
SF*
and
Level
of
Concern
for
Risk
Assessment
Study
and
Toxicological
Effects
Cancer
(
oral,
dermal,
inhalation)
Classification:
"
Not
likely
to
be
carcinogenic
to
humans"

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,
MOE
=
margin
of
exposure,
LOC
=
level
of
concern,
NA
=
Not
Applicable
V.
Results/
Discussion
As
stated
above,
for
an
acute
assessment,
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
acute
dietary
(
food
+
water)
exposure
analysis
results
are
reported
in
Table
3
for
females
13­
49
years
of
age
which
is
the
only
population
subgroup
of
concern
toxicologically
identified
at
this
time.
The
resulting
food
exposure
estimates
are
below
HED's
level
of
concern
for
this
population
subgroup,
5%
of
the
aPAD
at
the
95th
percentile.

The
chronic
dietary
exposure
analysis
results
reported
in
Table
4
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
resulting
food
exposure
estimates
are
below
HED's
level
of
concern
for
all
population
subgroups,
<
1%
of
the
cPAD.

Table
3:
Summary
of
Acute
Dietary
(
food
+
water)
Exposure
and
Risk
for
Ethofumesate.

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

Females
13­
49
years
old
0.3
5
0.013586
8
0.023873
15
0.043772
Table
4:
Summary
of
Chronic
Dietary
(
food+
water)
Exposure
and
Risk
for
Ethofumesate.

Exposure
(
mg/
kg/
day)
%
cPAD
Population
Subgroup
cPAD
(
mg/
kg/
day)

General
U.
S.
Population
0.002352
<
1
All
Infants
(<
1
year
old)
1.3
0.010524
<
1
Ethofumesate
Dietary
Exposure
Assessment
DP
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PC
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Page:
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19
Exposure
(
mg/
kg/
day)
%
cPAD
Population
Subgroup
cPAD
(
mg/
kg/
day)

Children
1­
2
years
old
0.005796
<
1
Children
3­
5
years
old
0.003972
<
1
Children
6­
12
years
old
0.002597
<
1
Youth
13­
19
years
old
0.001536
<
1
Adults
20­
49
years
old
0.001925
<
1
Adults
50+
years
old
0.002136
<
1
Females
13­
49
years
old
0.3
0.001962
<
1
VI.
Conclusions
An
acute
and
chronic
dietary
(
food+
water)
risk
assessment
was
conducted
using
the
Dietary
Exposure
Evaluation
Model
software
with
the
Food
Commodity
Intake
Database
(
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
analysis
was
performed
to
support
the
reregistration
eligibility
decision.
The
acute
and
chronic
dietary
exposure/
risk
analyses
were
conducted
using
tolerance
values,
default
processing
factors,
processing
factor
from
sugar
beet
processing
studies,
100%
crop
treated
for
all
commodities,
and
a
point
estimate
value,
the
maximum
concentration
for
acute
dietary
risk
assessment,
and
the
average
concentration
for
chronic
dietary
risk
assessment,
from
PRZM/
EXAMS
for
drinking
water
contribution
to
exposure.

Based
in
this
Tier
1
(
unrefined)
assessment,
the
team
selected
the
95th
percentile
of
exposure
to
estimate
acute
dietary
risk
from
food
and
water.
No
monitoring
data
are
available
for
ethofumesate.

This
assessment
concludes
that
for
all
supported
commodities,
the
acute
dietary
exposure
estimates
are
below
HED's
level
of
concern
for
females
13­
49
years
of
age
at
5
%
of
the
aPAD
at
the
95th
percentile.

This
assessment
concludes
that
for
all
supported
commodities,
the
chronic
dietary
exposure
estimates
are
below
HED's
level
of
concern
for
all
population
subgroups
at
<
1%
of
the
cPAD.

VII.
List
of
Attachments
°
Attachment
1:
Acute
Food
Residue
Input
file
and
RDFs.
°
Attachment
2:
Acute
Results
file.
Ethofumesate
Dietary
Exposure
Assessment
DP
Barcode:
DP296947
PC
Code:
110601
Page:
13
of
19
°
Attachment
3:
Chronic
Residue
Input
file.
°
Attachment
4:
Chronic
Results
file.
Ethofumesate
Dietary
Exposure
Assessment
DP
Barcode:
DP296947
PC
Code:
110601
Page:
14
of
19
Attachment
1.
Acute
Food
Residue
Input
file
U.
S.
Environmental
Protection
Agency
Ver.
2.02
DEEM­
FCID
Acute
analysis
for
ETHOFUMESATE
Residue
file
name:
C:\
My
DEEM\
Ethofumesate\
EthofumesateAcute.
R98
Analysis
Date
06­
23­
2004
Residue
file
dated:
06­
23­
2004/
15:
42:
12/
8
Reference
dose
(
aRfD)
=
0.3
mg/
kg
bw/
day
Comment:
Food
+
Water
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
­­­
EPA
Crop
Def
Res
Adj.
Factors
Comment
Code
Grp
Food
Name
(
ppm)
#
1
#
2
­­­­­­­­
­­­­
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
­­­­­­­­­­
­­­­­­
­­­­­­
­­­
­­­­
21000440
M
Beef,
meat
0.050000
1.000
1.000
21000441
M
Beef,
meat­
babyfood
0.050000
1.000
1.000
21000450
M
Beef,
meat,
dried
0.050000
1.920
1.000
21000460
M
Beef,
meat
byproducts
0.050000
1.000
1.000
21000461
M
Beef,
meat
byproducts­
babyfood
0.050000
1.000
1.000
21000470
M
Beef,
fat
0.050000
1.000
1.000
21000471
M
Beef,
fat­
babyfood
0.050000
1.000
1.000
21000480
M
Beef,
kidney
0.050000
1.000
1.000
21000490
M
Beef,
liver
0.050000
1.000
1.000
21000491
M
Beef,
liver­
babyfood
0.050000
1.000
1.000
01010500
1AB
Beet,
garden,
roots
0.500000
1.000
1.000
01010501
1AB
Beet,
garden,
roots­
babyfood
0.500000
1.000
1.000
02000510
2
Beet,
garden,
tops
5.000000
1.000
1.000
01010520
1A
Beet,
sugar
0.200000
1.000
1.000
01010521
1A
Beet,
sugar­
babyfood
0.200000
1.000
1.000
01010530
1A
Beet,
sugar,
molasses
0.500000
1.000
1.000
01010531
1A
Beet,
sugar,
molasses­
babyfood
0.500000
1.000
1.000
01010780
1AB
Carrot
7.000000
1.000
1.000
01010781
1AB
Carrot­
babyfood
7.000000
1.000
1.000
01010790
1AB
Carrot,
juice
7.000000
1.000
1.000
23001690
M
Goat,
meat
0.050000
1.000
1.000
23001700
M
Goat,
meat
byproducts
0.050000
1.000
1.000
23001710
M
Goat,
fat
0.050000
1.000
1.000
23001720
M
Goat,
kidney
0.050000
1.000
1.000
23001730
M
Goat,
liver
0.050000
1.000
1.000
24001890
M
Horse,
meat
0.050000
1.000
1.000
26003390
M
Sheep,
meat
0.050000
1.000
1.000
26003391
M
Sheep,
meat­
babyfood
0.050000
1.000
1.000
26003400
M
Sheep,
meat
byproducts
0.050000
1.000
1.000
26003410
M
Sheep,
fat
0.050000
1.000
1.000
26003411
M
Sheep,
fat­
babyfood
0.050000
1.000
1.000
26003420
M
Sheep,
kidney
0.050000
1.000
1.000
Ethofumesate
Dietary
Exposure
Assessment
DP
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DP296947
PC
Code:
110601
Page:
15
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19
26003430
M
Sheep,
liver
0.050000
1.000
1.000
86010000
O
Water,
direct,
all
sources
0.200000
1.000
1.000
86020000
O
Water,
indirect,
all
sources
0.200000
1.000
1.000
Ethofumesate
Dietary
Exposure
Assessment
DP
Barcode:
DP296947
PC
Code:
110601
Page:
16
of
19
Attachment
2.
Acute
Results
file
U.
S.
Environmental
Protection
Agency
Ver.
2.02
DEEM­
FCID
ACUTE
Analysis
for
ETHOFUMESATE
(
1994­
98
data)
Residue
file:
EthofumesateAcute.
R98
Adjustment
factor
#
2
used.
Analysis
Date:
06­
23­
2004/
15:
44:
29
Residue
file
dated:
06­
23­
2004/
15:
42:
12/
8
Daily
totals
for
food
and
foodform
consumption
used.
Run
Comment:
"
Food
+
Water"
===============================================================================

Summary
calculations
(
per
capita):

95th
Percentile
99th
Percentile
99.9th
Percentile
Exposure
%
aRfD
Exposure
%
aRfD
Exposure
%
aRfD
­­­­­­­­­­
­­­­­­­­
­­­­­­­­­­
­­­­­­­­
­­­­­­­­­­
­­­­­­­­
Females
13­
49
yrs:
0.013586
4.53
0.023873
7.96
0.043772
14.59
Ethofumesate
Dietary
Exposure
Assessment
DP
Barcode:
DP296947
PC
Code:
110601
Page:
17
of
19
Attachment
3.
Chronic
Food
Residue
Input
file
U.
S.
Environmental
Protection
Agency
Ver.
2.00
DEEM­
FCID
Chronic
analysis
for
ETHOFUMESATE
1994­
98
data
Residue
file:
C:\
My
DEEM\
Ethofumesate\
EthofumesateCHR.
R98
Adjust.
#
2
used
Analysis
Date
06­
23­
2004
Residue
file
dated:
06­
23­
2004/
15:
42:
42/
8
Reference
dose
(
RfD)
=
1.3
mg/
kg
bw/
day
Comment:
Food
+
Water
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
­­­
Food
Crop
Residue
Adj.
Factors
Comment
EPA
Code
Grp
Food
Name
(
ppm)
#
1
#
2
­­­­­­­­
­­­­
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
­­­­­­­­­­
­­­­­­
­­­­­­
­­­­­­­
21000440
M
Beef,
meat
0.050000
1.000
1.000
21000441
M
Beef,
meat­
babyfood
0.050000
1.000
1.000
21000450
M
Beef,
meat,
dried
0.050000
1.920
1.000
21000460
M
Beef,
meat
byproducts
0.050000
1.000
1.000
21000461
M
Beef,
meat
byproducts­
babyfood
0.050000
1.000
1.000
21000470
M
Beef,
fat
0.050000
1.000
1.000
21000471
M
Beef,
fat­
babyfood
0.050000
1.000
1.000
21000480
M
Beef,
kidney
0.050000
1.000
1.000
21000490
M
Beef,
liver
0.050000
1.000
1.000
21000491
M
Beef,
liver­
babyfood
0.050000
1.000
1.000
01010500
1AB
Beet,
garden,
roots
0.500000
1.000
1.000
01010501
1AB
Beet,
garden,
roots­
babyfood
0.500000
1.000
1.000
02000510
2
Beet,
garden,
tops
5.000000
1.000
1.000
01010520
1A
Beet,
sugar
0.200000
1.000
1.000
01010521
1A
Beet,
sugar­
babyfood
0.200000
1.000
1.000
01010530
1A
Beet,
sugar,
molasses
0.500000
1.000
1.000
01010531
1A
Beet,
sugar,
molasses­
babyfood
0.500000
1.000
1.000
01010780
1AB
Carrot
7.000000
1.000
1.000
01010781
1AB
Carrot­
babyfood
7.000000
1.000
1.000
01010790
1AB
Carrot,
juice
7.000000
1.000
1.000
23001690
M
Goat,
meat
0.050000
1.000
1.000
23001700
M
Goat,
meat
byproducts
0.050000
1.000
1.000
23001710
M
Goat,
fat
0.050000
1.000
1.000
23001720
M
Goat,
kidney
0.050000
1.000
1.000
23001730
M
Goat,
liver
0.050000
1.000
1.000
24001890
M
Horse,
meat
0.050000
1.000
1.000
26003390
M
Sheep,
meat
0.050000
1.000
1.000
Ethofumesate
Dietary
Exposure
Assessment
DP
Barcode:
DP296947
PC
Code:
110601
Page:
18
of
19
26003391
M
Sheep,
meat­
babyfood
0.050000
1.000
1.000
26003400
M
Sheep,
meat
byproducts
0.050000
1.000
1.000
26003410
M
Sheep,
fat
0.050000
1.000
1.000
26003411
M
Sheep,
fat­
babyfood
0.050000
1.000
1.000
26003420
M
Sheep,
kidney
0.050000
1.000
1.000
26003430
M
Sheep,
liver
0.050000
1.000
1.000
86010000
O
Water,
direct,
all
sources
0.040000
1.000
1.000
86020000
O
Water,
indirect,
all
sources
0.040000
1.000
1.000
Attachment
4.
Chronic
Results
file
U.
S.
Environmental
Protection
Agency
Ver.
2.00
DEEM­
FCID
Chronic
analysis
for
ETHOFUMESATE
(
1994­
98
data)
Residue
file
name:
C:\
My
DEEM\
Ethofumesate\
EthofumesateCHR.
R98
Adjustment
factor
#
2
used.
Analysis
Date
06­
23­
2004/
15:
46:
33
Residue
file
dated:
06­
23­
2004/
15:
42:
42/
8
Reference
dose
(
RfD,
Chronic)
=
1.3
mg/
kg
bw/
day
COMMENT
1:
Food
+
Water
=============================================================================
==
Total
exposure
by
population
subgroup
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
­­

Total
Exposure
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
Population
mg/
kg
Percent
of
Subgroup
body
wt/
day
PAD
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
­­­­­­­­­­­­­
­­­­­­­­­­­­­­­
U.
S.
Population
(
total)
0.002352
0.2%

U.
S.
Population
(
spring
season)
0.002308
0.2%
U.
S.
Population
(
summer
season)
0.002201
0.2%
U.
S.
Population
(
autumn
season)
0.002419
0.2%
U.
S.
Population
(
winter
season)
0.002486
0.2%

Northeast
region
0.002359
0.2%
Midwest
region
0.002367
0.2%
Southern
region
0.002085
0.2%
Western
region
0.002753
0.2%

Hispanics
0.002580
0.2%
Non­
hispanic
whites
0.002357
0.2%
Non­
hispanic
blacks
0.001840
0.1%
Non­
hisp/
non­
white/
non­
black
0.003180
0.2%
Ethofumesate
Dietary
Exposure
Assessment
DP
Barcode:
DP296947
PC
Code:
110601
Page:
19
of
19
All
infants
(<
1
year)
0.010524
0.8%
Nursing
infants
0.005934
0.5%
Non­
nursing
infants
0.012266
0.9%
Children
1­
6
yrs
0.004521
0.3%
Children
7­
12
yrs
0.002413
0.2%

Females
13­
19
(
not
preg
or
nursing)
0.001507
0.1%
Females
20+
(
not
preg
or
nursing)
0.002113
0.2%
Females
13­
50
yrs
0.002098
0.2%
Females
13+
(
preg/
not
nursing)
0.002175
0.2%
Females
13+
(
nursing)
0.003287
0.3%

Males
13­
19
yrs
0.001550
0.1%
Males
20+
yrs
0.001863
0.1%
Seniors
55+
0.002174
0.2%

Children
1­
2
yrs
0.005796
0.4%
Children
3­
5
yrs
0.003972
0.3%
Children
6­
12
yrs
0.002597
0.2%
Youth
13­
19
yrs
0.001536
0.1%
Adults
20­
49
yrs
0.001925
0.1%
Adults
50+
yrs
0.002136
0.2%
Females
13­
49
yrs
(.
3*)
0.001962
0.7%

*
PAD
in
mg/
kg­
bw­
day