Document ID: EPA-HQ-OPP-2005-0245-0005
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2006-08-02T04:00Z

UNITED
STATES
ENVIRONMENTAL
PROTECTION
AGENCY
WASHINGTON,
D.
C.
20460
OFFICE
OF
PREVENTION,
PESTICIDES
AND
TOXIC
SUBSTANCES
MEMORANDUM
DATE:
May
22,
2006
SUBJECT:
Fenhexamid.
Chronic
Dietary
Exposure
Assessment
for
Section
3
Tolerance
Requests
on
Cilantro
(
Transplant
/
Greenhouse),
Non­
Bell
Pepper
(
Transplant)
and
Pomegranate
(
Post­
Harvest).
1
PC
Code
090209.
DP
Barcodes:
D328660
REVIEWER:
Wesley
C.
Carr,
Jr.,
M.
S.,
Associate
Toxicologist
Medical
Toxicology
Branch,
California
Department
of
Pesticide
Regulation,
Cal/
EPA
THROUGH:
Joyce
Gee,
Ph.
D.,
Senior
Toxicologist
Medical
Toxicology
Branch
California
Department
of
Pesticide
Regulation,
Cal/
EPA
and
Gary
Patterson,
Ph.
D.,
Supervising
Toxicologist
Medical
Toxicology
Branch
California
Department
of
Pesticide
Regulation,
Cal/
EPA
and
Christina
Swartz,
Branch
Chief
Registration
Action
Branch
II
(
RABII)
Health
Effects
Division
(
7509B)

TO:
John
C.
Redden,
ARIA
Team
Risk
Integration
Minor
Use
and
Emergency
Response
Branch
(
RIMUERB)
Registration
Division
(
7505B)

Executive
Summary
1
This
assessment
was
developed
as
part
of
a
cooperative
work­
share
program
between
the
California
Department
of
Pesticide
Regulation
(
CDPR)
and
the
U.
S.
Environmental
Protection
Agency
(
USEPA).
The
toxicity
studies/
endpoints,
No
Observable
Adverse
Effects
Levels
(
NOAELs),
exposure
assumptions
and
consumption
databases
used
in
this
document
were
selected
by
the
U.
S.
EPA.
A
separate
DPR
assessment
for
the
same
pesticide
may
produce
different
results.
USEPA
comments
and
revisions
(
Christina
Swartz;
Branch
Chief;
HED;
RABII)
have
been
incorporated
into
this
review.
A
chronic
(
U.
S.
and
all
population
subgroups)
dietary
(
food+
water)
exposure
analysis
was
conducted
in
order
to
determine
the
dietary
exposure
estimates
associated
with
the
proposed
new
uses
of
fenhexamid
on
cilantro
(
transplant
/
greenhouse),
non­
bell
pepper
(
transplant
only)
and
pomegranate
(
post­
harvest).
An
unrefined
(
Tier
1)
chronic
(
general
U.
S.
population
and
associated
population
subgroups)
dietary
exposure
assessment
was
performed
using
tolerance­
level
residues
and
100%
crop
treated
(
100%
CT)
information
for
all
registered
and
proposed
uses.
The
results
of
this
fenhexamid
assessment
demonstrated
that
the
chronic
dietary
exposure
estimate
was
below
the
Health
Effects
Division's
(
HED)
level
of
concern
[<
100%
chronic
Population
Adjusted
Dose
(
cPAD)]
for
all
population
subgroups.
The
most
highly
exposed
population
subgroups
is
children
1­
2
years
of
age
at
28%
of
the
cPAD.
The
addition
of
the
proposed
tolerance
petitions
(
non­
bell
pepper,
pomegranate
and
cilantro)
to
current
existing
fenhexamid
tolerances
(
40
CFR
180.553)
is
supported
and
do
not
result
in
an
unacceptable
level
of
chronic
dietary
exposure
and
risk.
No
acute
dietary
assessment
was
conducted.

I.
Introduction
Dietary
risk
assessment
incorporates
both
exposure
and
toxicity
of
a
given
pesticide.
Dietary
risk
expressed
as
a
percentage
of
the
maximum
acceptable
dose
for
both
acute
and
chronic
assessments
is
the
population­
adjusted­
dose
(
PAD).
The
HED
has
determined
that
exposure
values
less
than
100%
of
the
PAD
will
result
in
no
unreasonable
adverse
health
effects.
The
PAD
is
the
Reference
Dose
(
RfD)
divided
by
the
Food
Quality
Protection
Act
(
FQPA)
Safety
Factor
(
1­
10X).
Dietary
risk
is
expressed
as
a
percentage
of
the
PAD
(
aPAD
or
cPAD).
HED
is
generally
concerned
when
estimated
dietary
risk
exceeds
100%
of
the
PAD.
References
and
additional
information
which
discuss
acute
and
chronic
risk
assessment
processes
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).

The
current
chronic
assessment
was
conducted
using
the
Dietary
Exposure
Evaluation
Model
software
using
the
Food
Commodity
Intake
Database
(
DEEM­
FCID
 
)
.
The
chronic
dietary
exposure
assessment
for
existing
section
3
and
18
tolerances
plus
the
proposed
section
3
requests
for
cilantro
(
transplant
and
greenhouse),
pepper,
non
bell
(
transplant
only)
and
pomegranate
(
post
harvest)
used
the
DEEM­
FCID
 
(
Version
7.76)
program.

II.
Residue
Information
Registered
and
Proposed
Fenhexamid
Tolerances:
New
section
3
tolerances
are
proposed
for
residues
of
fenhexamid
(
40
CFR
180.553)
[
N­(
2,3­
dichloro­
4­
hydroxyphenyl)­
1­
methylcyclohexane
carboxamide]
in/
on
non­
bell
peppers
(
post­
harvest
only),
pomegranate
and
cilantro
using
leafy
greens,
except
spinach,
(
subgroup
4A
crop
group
as
the
surrogate
tolerance).
Existing
permanent
fenhexamid
commodity
tolerances
in/
on
almond
(
0.02
ppm),
bushberry
subgroup
13B
(
5.0
ppm),
caneberry
subgroup
13A
(
20.0
ppm),
cucumber
(
2.0
ppm),
stonefruit,
group
12,
except
plum,
prune,
fresh,
post­
harvest
(
10.0
ppm),
grape
(
4.0
ppm),
grape,
raisin
(
6.0
ppm),
juneberry
(
5.0
ppm),
kiwifruit,
post­
harvest
(
15.0
ppm),
leafy
greens,
subgroups
4A,
except
spinach
(
30.0),
lingonberry
(
5.0
ppm),
pistachio
(
0.02
ppm),
plum,
prune,
dried
(
2.5
ppm),
plum,
prune,
fresh
(
1.5
ppm),
salal
(
5.0
ppm),
strawberry
(
3.0
ppm),
vegetable,
fruiting,
group
8,
except
non­
bell
pepper
(
2.0
ppm)
have
been
evaluated
in
prior
U.
S.
EPA
and
DPR
memorandums
(
B.
Hanson,
11/
07/
2005
and
12/
19/
2005;
W.
Carr,
05/
21/
2003).
The
HED­
recommended
and
DPR
reviewed
proposed
tolerances
are
listed
in
Table
1.
The
residue
chemistry
databases
are
adequate
to
support
the
following
fenhexamid
tolerances
for
non­
bell
peppers
(
post­
harvest
only),
pomegranate
and
cilantro.

Table
1.
HED­
Recommended
Fenhexamid
Tolerances
for
Dietary
Risk
Assessment.

Commodity
1
Recommended
Tolerance
(
ppm)
Processing
Factor
2
Pepper,
non­
bell
(
Transplant)
0.02
N/
A
Pomegranate
(
Postharvest
2.0
N/
A
Cilantro
(
uses
Leafy
Vegetables,
except
spinach,
4A
crop
group
tolerance
as
surrogate)
30.0
N/
A
1
Proposed
40
CFR
180.553
tolerances.
Crop
group
tolerances
appear
in
Italics
(
if
any).
2
DEEM
 
default
adjustment
factor
#
1
(
AF1)
values
are
used
in
the
DEEM
­
FCID
 
program
unless
otherwise
noted.
3
The
proposed
tolerance
for
Pomegranate
was
3.0
ppm.
The
Tolerance
Calculator
(
see
NAFTA
Tolerance/
MRL
Harmonization
Workgroup;
May
9,
2005)
recommended
2.0
ppm.

Processing
Factors:
No
processing
data
for
the
proposed
commodity
tolerances
were
required.
The
DEEM­
FCID
 
processing
factors
used
in
the
dietary
exposure
analysis
originated
from
the
default
processing
factors
found
within
the
DEEM
 
ver
7.76
program.
These
default
factors
were
used
for
all
the
proposed
processed
commodities
unless
stated
otherwise
(
See
Table
1).
There
is
not
a
food
code
for
cilantro.
However,
coriander
is
another
common
commodity
name
for
cilantro
and
was
used
in
the
DEEM­
FCID
 
dietary
exposure
analysis.

Magnitude
of
the
Residues:
Except
for
cilantro,
the
pomegranate
and
non­
bell
pepper
proposed
tolerances
were
established
based
on
results
from
magnitude
of
the
residue
(
MOR)
field
trial
studies.
The
proposed
cilantro
tolerance
uses
the
Leafy
Greens
(
except
spinach)
Crop
Subgroup
4A
as
a
surrogate.
A
summary
of
the
proposed
tolerances
are
listed
in
Table
1.
Commodities
with
existing
section
3
or
18
fenhexamid
tolerances
are
not
described
herein,
but
are
instead
found
in
the
DEEM­
FCID
 
chronic
dietary
residue
file
attachment.
The
proposed
cilantro,
pomegranate
and
non­
bell
pepper
commodity
tolerance
residue
data
from
IR­
4
project
were
reviewed
for
U.
S.
EPA
by
the
California
Department
of
Pesticide
Regulation
(
DPR
memo
to
U.
S.
EPA
dated
11/
16/
2005;
C.
Peoples
and
M.
Papathakis).

Non­
bell
Pepper
(
PP
4E6860):
An
IR­
4
report
of
non­
bell
pepper
(
transplant
use)
field
trial
data
for
fenhexamid
from
3
magnitude­
of­
the­
residue
(
MOR)
trials
conducted
in
Georgia,
Florida
and
Texas
during
2000
was
submitted
for
evaluation
(
DPR
memo
dated
11/
16/
2005;
C.
Peoples
and
M.
Papathakis).
Fenhexamid
(
Elevate
50
WDG
)
was
applied
4
times
to
non­
bell
peppers
prior
to
transplanting
as
a
foliar
broadcast
spray
at
the
rate
of
approximately
4
lb
a.
i./
A
(
maximum
seasonal
rate
of
16
lb
a.
i./
A)(
Table
2).
No
adjuvants
were
used
during
application.
Non­
bell
pepper
control
samples
were
fortified
with
fenhexamid
and
analyzed
concurrently
with
treated
field
samples.
The
method
concurrent
recoveries
ranged
from
70
to
100
%
with
a
mean
of
85%.
A
Limit
of
Quantification
(
LOQ)
level
of
0.021
ppm
and
a
Limit
of
Detection
(
LOD)
level
of
0.007
ppm
were
reported.
The
results
from
these
field
trials
show
that
fenhexamid
applied
to
non­
bell
pepper
prior
to
transplant
at
the
exaggerated
rates
resulted
in
residues
below
the
LOQ
level
(
0.02
ppm).
The
proposed
tolerance
value
of
0.02
ppm
was
used
in
the
fenhexamid
chronic
dietary
exposure
assessment.

TABLE
2.
Residue
Data
from
Non­
Bell
Pepper
Crop
Field
Trials
with
Fenhexamid.

Trial
ID
(
City,
State/
Year)
Region
Crop/
Variety
Commodity
or
Matrix
Total
Rate,
(
lb
a.
i./
A)
PHI
(
days)
Fenhexamid
(
ppm)
Residues
2
(
ppm)
Residues
3
(
ppm)

Tifton,
GA
(
GA20)
2
Hungarian
Hot
Wax
Non­
bell
pepper
17.53
64
<
0.02
Gainesville,
FL
(
FL53)
3
Pecos
Non­
bell
pepper
18.08
121
<
0.02
Weslaco,
TX
(
TX43)
6
Sonora
Anaheim
Non­
bell
pepper
20.94
66
<
0.02
Pomegranate
(
PP
4E6857):
One
magnitude­
of­
the­
residue
(
MOR)
trial
was
conducted
during
2002.
Two
separate
lots
of
California­
grown
pomegranates
were
treated
with
fenhexamid
post­
harvest
(
Elevate
50
WDG)(
DPR
memo
dated
11/
16/
2005;
C.
Peoples
and
M.
Papathakis).
The
approximate
rate
of
0.75
lb
a.
i./
100
gallon
(
proposed
maximum
label
rate)
was
applied
postharvest
as
a
30­
second
dip.
The
maximum
detected
residue
on
pomegranates
was
1.845
ppm
(
Table
3).
Storage
stability
data
indicate
that
the
residues
were
stable
under
the
conditions
in
which
the
samples
were
held
between
post­
harvest
treatments
and
analysis.
Recoveries
for
fenhexamid
on
pomegranate
ranged
from
64
to
94%
and
method
concurrent
recoveries
ranged
from
87
to
99%.
The
reported
analytical
Limit
of
Quantification
(
LOQ)
was
0.03
ppm
with
a
method
Limit
of
Detection
(
LOD)
of
0.01
ppm.
The
proposed
tolerance
for
Pomegranate
was
3.0
ppm.
The
Tolerance
Calculator
(
see
NAFTA
Tolerance/
MRL
Harmonization
Workgroup;
May
9,
2005)
recommended
2.0
ppm.
The
value
of
2.0
ppm
was
used
in
the
dietary
exposure
assessment
to
represent
pomegranate
at
tolerance.

TABLE
3.
Summary
of
Residue
Data
from
Crop
Field
Trials
with
Fenhexamid.

Commodity
Total
Applic.
Rate,
(
lb
a.
i./
100
gal)
PHI
(
days)
Residue
Levels
(
ppm)

n
Min.
Max.
HAFT
1
Median
(
STMdR)
Mean
(
STMR)
Std.
Dev.

Specify
analyte
:
Fenhexamid
Pomegranate
0.751
NA
4
1.585
1.845
1.7875
1.71,
1.73
1.7175
0.1065
1
HAFT
=
Highest
Average
Field
Trial.
Cilantro
­
Using
Leafy
Greens
(
Except
Spinach)
Crop
Subgroup
4A
Surrogate
(
PP
4E6857):
The
cilantro,
also
known
as
coriander,
petition
cites
commodity
definition
and
surrogate
residue
data
to
establish
the
proposed
tolerance.
The
IR­
4
submission
package
for
pomegranate
included
the
cilantro
petition.
No
specific
cilantro
MOR
data
were
provided.
However,
it
was
stated
that
cilantro
/
coriander
is
described
in
the
definition
of
parsley
and
should
therefore
be
included
in
the
Leafy
Greens
(
Except
Spinach)
Crop
Subgroup
4A
tolerance.
In
a
May
21,
2003
memo
(
W.
Carr
to
J.
Redden),
a
30
ppm
crop
group
tolerance
for
Leafy
Greens
(
Except
Spinach)
Crop
Subgroup
4A
was
recommended
based
on
results
from
European
MOR
field
trials
conducted
on
greenhouse
grown
lettuce
(
MRID#
457956­
01
and
458171­
01).
The
30
ppm
crop
subgroup
4A
tolerance
value
was
used
in
the
current
chronic
dietary
exposure
assessment
to
represent
cilantro.
III.
DEEM­
FCID
 
Program
and
Consumption
Information
The
fenhexamid
chronic
dietary
(
food+
water)
exposure
assessment
was
conducted
using
the
DEEM­
FCID
 
(
Version
7.76)
dietary
exposure
program.
DEEM­
FCID
 
incorporates
consumption
data
from
the
Continuing
Surveys
of
Food
Intakes
by
Individuals
(
CSFII)
administered
by
the
USDA
and
collected
during
1994­
1996
and
1998.
The
1994­
96,
1998
nationwide
survey
data
are
based
on
reported
consumption
by
more
than
20,000
individuals
over
two
non­
consecutive
days.

Drinking
water
exposure
estimates
for
fenhexamid
in
surface
water
and
groundwater
were
calculated
using
the
screening
model
FIRST
(
FQPA
Index
Reservoir
Screening
Tool)
and
regression
model
SCI­
GROW,
respectively.
Estimated
Environmental
Concentrations
(
EEC's)
for
fenhexamid
in
drinking
water
sources
are
29
ppb
(
acute)
and
1.14
ppb
(
chronic)
for
surface
water
and
0.0007
ppb
for
groundwater.

Publicly
available
recipe
translation
files
developed
jointly
by
EPA
and
the
United
States
Department
of
Agriculture
Agricultural
Research
Service
(
USDA­
ARS)
were
used
to
link
foods
reported
"
as
consumed"
(
e.
g.,
apple
pie)
with
EPA
defined
food
commodities
(
e.
g.
apples,
peeled
fruit
­
cooked;
fresh
or
N/
S;
baked)
contained
in
the
dietary
exposure
software.
Consumption
data
for
chronic
exposure
are
averaged
for
the
entire
U.
S.
population
and
population
subgroups.
However,
these
data
are
retained
as
individual
consumption
events
for
acute
exposure.
HED
evaluated
the
1994­
96,
1998
CSFII
consumption
data,
dietary
patterns,
and
survey
respondents.
Based
on
the
analysis,
HED
concluded
that
several
population
subgroups
are
the
most
appropriate
to
use
to
report
dietary
risk.
The
population
subgroups
are:
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.

An
estimate
of
each
food
or
food­
form
(
e.
g.,
orange
or
orange
juice)
residue
level
on
the
commodity
residue
list
is
multiplied
by
the
average
daily
consumption
estimate
for
the
chronic
dietary
exposure
assessment.
The
residue
consumption
estimate
for
each
food
or
food­
form
is
then
summed
with
the
residue
consumption
estimates
for
the
other
foods
or
food­
forms
on
the
commodity
residue
list.
The
final
value
represents
the
total
average
estimated
dietary
exposure.
Exposure
is
expressed
in
mg/
kg
body
weight/
day
and
as
a
percent
of
the
chronic
PAD
(
cPAD).
The
total
average
estimated
chronic
dietary
exposure
is
calculated
for
each
population
subgroup.
No
acute
exposure
assessment
was
conducted
because
no
appropriate
acute
dietary
endpoint
was
established.
IV.
Acute
Dietary
Exposure
Analysis
Based
on
the
toxicological
data
evaluated
by
U.
S.
EPA,
a
fenhexamid
acute
dietary
analysis
is
not
required.

V.
Chronic
Dietary
Exposure
Analysis
The
DEEM­
FCID
 
analysis
software
estimates
the
dietary
exposure
of
the
U.
S.
population
and
26
population
subgroups.
The
results
reported
in
Table
4
are
for
the
general
U.
S.
Population,
all
infants
(<
1
year
old),
children
1­
2,
children
3­
5,
children
6­
12,
youths
13­
19,
females
13­
49,
adults
20­
49
and
seniors
50+
years.
The
results
for
all
the
population
subgroups
are
listed
in
Attachment
2.
HED's
threshold
level
of
concern
is
exceeded
when
dietary
exposure
is
greater
than
100%
of
either
the
acute
or
chronic
(
aPAD
/
cPAD).

Based
on
the
chronic
dietary
endpoint
selected
for
all
the
population
subgroups,
an
unrefined
(
i.
e.
Tier
1)
dietary
exposure
assessment
using
tolerance­
level
residues
and
default
100%
CT
information
(
all
current/
proposed
tolerances)
was
conducted.
The
results
for
the
general
U.
S.
population
(
10%
cPAD)
and
all
related
population
subgroups
indicate
that
the
chronic
dietary
exposure
estimates
are
below
the
threshold
levels
of
concern
for
HED
(<
100%
cPAD).
The
most
highly
exposed
population
subgroups
are
non­
nursing
infants
and
children
1­
2
years
old
at
approximately
22%
of
the
cPAD
(
Table
4).

Table
4.
Summary
of
Tier
1
Estimates
of
Exposure
and
Risk
from
Chronic
Dietary
Exposure
to
Fenhexamid.

Chronic
1
Population
Subgroup
Dietary
Exposure
(
mg/
kg/
day)
%
cPAD
U.
S.
Population
­
48
States
­
all
seasons
0.018220
11
All
Infants
(<
1
year)
0.0035239
21
Non­
Nursing
Infants
(<
1
year
old)
0.040755
24
Children
(
1­
2
years)
0.048249
28
Children
(
3­
5
years)
0.035835
21
Females
(
13­
49
years)
0.015590
9
Youths
(
13­
19
years)
0.014283
8
Adults
(
20­
49
years)
0.015135
9
Adults
(
50+
years)
0.015498
9
1.
The
chronic
dietary
cPAD
of
0.17
mg/
kg/
day
applies
to
the
general
U.
S.
population
and
all
population
subgroups.

VI.
Toxicological
Information
A
summary
of
the
toxicological
doses
and
selected
endpoints
used
in
the
fenhexamid
risk
assessment
are
presented
in
Table
5.
A
detailed
description
of
the
selected
doses
and
endpoints
are
contained
in
the
Hazard
Identification
Assessment
Review
Committee's
(
HIARC)
re­
review
of
the
fenhexamid
toxicological
database
dated
March
26,
2003.
The
purpose
of
the
second
review
was
to
address
infants
and
children
sensitivity
requirements
under
the
Food
Quality
Protection
Act
(
FQPA)
in
response
to
a
Natural
Resources
Defense
Council
(
NRDC)
petition
(
Memo,
B.
Tarplee,
TXR
NO.
0051704,
26
March
2003,
"
Fenhexamid
­
2nd
Report
of
the
Hazard
Identification
Assessment
Review
Committee").
The
March
26,
2003
document
revises
the
previous
March
4,
1999
HIARC
report
(
HED
DOC.
NO.
013258).
The
FQPA
review
did
not
make
any
changes
to
the
toxicology
endpoints
selected
in
the
earlier
HIARC
evaluation
but
did
remove
the
3x
FQPA
Safety
Factor
(
memo,
E.
Budd,
3/
4/
99,
Doc.
No.
013258).
A
HIARC
determination
was
made
that
only
a
chronic
endpoint
was
necessary
for
the
fenhexamid
dietary
exposure
assessment
(
Table
5).
The
HIARC
committee
determined
that
an
acute
dietary
exposure
assessment
was
not
necessary.
HIARC
also
classified
fenhexamid
as
a
"
not
likely"
human
carcinogen.
Therefore,
a
lifetime
(
cancer)
dietary
risk
assessment
was
not
required.
The
Health
Effects
Division's
(
HED)
FQPA
Safety
Factor
Committee
decided
that
an
FQPA
Safety
Factor
of
1x
is
sufficient
to
protect
infants
and
children
(
memo,
B.
Tarplee,
3/
26/
03).
The
FQPA
Safety
Factor
applies
to
all
population
subgroups
for
the
chronic
dietary
risk
assessment.
The
chronic
PAD
(
cPAD)
is
0.17
mg/
kg/
day
(
0.17
mg/
kg/
day
chronic
RfD
÷
1x
FQPA
safety
factor).
While
there
is
no
longer
a
standing
HIARC
committee,
no
new
toxicology
endpoints
data
have
been
presented
and
reviewed
for
fenhexamid
and
the
previously
selected
endpoints
and
uncertainty
factors
are
considered
relevant
for
the
current
assessment.
The
current
status
of
the
toxicology
was
reflected
in
the
most
recent
fenhexamid
pesticide
petition
action
for
ginseng
dated
December
19,
2005
(
Petition
4E6859
memo,
B.
Hanson).

Table
5
Summary
of
Toxicology
Dose
and
Endpoints
for
Fenhexamid
1
Exposure
Scenario
Dose
Used
in
Risk
Assessment,
UF
FQPA
SF*
and
Endpoint
for
Risk
Assessment
Study
and
Toxicological
Effects
Acute
Dietary
(
general
population
including
infants
and
children)
None
UF
=
NA
Acute
RfD
=
None
FQPA
SF
=
1X
aPAD
=
acute
RfD
FQPA
SF
=
None
Not
selected.
No
appropriate
toxicological
endpoint
attributable
to
a
single
exposure
was
identified
in
the
available
toxicology
studies.

Chronic
Dietary
(
All
populations)
NOAEL
=
17
mg/
kg/
day
UF
=
100
Chronic
RfD
=
0.17
mg/
kg/
day
1X
cPAD
=
chronic
RfD
FQPA
SF
=
0.17
mg/
kg/
day
1­
Year
Feeding­
Dog.
Decreased
RBC
count,
hemoglobin
and
hematocrit
and
increased
Heinz
bodies
in
males
and
females;
increased
adrenal
weights
and
intracytoplasmic
vacuoles
in
adrenal
cortex
in
females.
at
the
LOAEL
of
124
mg/
kg/
day.
1.
UF
=
uncertainty
factor,
FQPA
SF
=
FQPA
safety
factor,
NOAEL
=
no
observed
adverse
effect
level,
LOAEL
=
lowest
observed
adverse
effect
level,
PAD
=
population
adjusted
dose
(
acute
/
chronic),
RfD
=
reference
dose,
and
NA
=
Not
Applicable.

VII.
Discussion
of
Assumptions
The
fenhexamid
chronic
dietary
exposure
assessment
used
several
default
assumptions
which
are
considered
health
protective.
The
chronic
assessment
used
tolerance­
level
residue
values,
default
processing
adjustment
factors
and
100%
CT
assumptions
for
all
of
the
registered
and
proposed
uses
(
Tier
1).
The
only
exceptions
were
processing
adjustment
factors
for
grape
juice,
grapes
destined
for
wine
and
sherry
production
and
dried
currants.
For
these
commodities,
U.
S.
EPA
defined
processing
adjustment
factors
were
used.
Otherwise,
DEEM
 
(
ver.
7.76)
default
processing
factors
were
used
for
all
of
the
other
processed
commodities
in
the
DEEM
 
(
ver.
2.03)
dietary
exposure
analysis.
Additional
refinements
were
not
required
to
support
the
3
new
tolerance
petitions.

VIII.
Conclusions
Based
on
the
chronic
dietary
endpoint
selected
for
all
the
population
subgroups,
an
unrefined
(
i.
e.
Tier
1)
chronic
dietary
(
food+
water)
exposure
assessment
was
conducted
using
tolerance­
level
residues
and
default
100%
CT
information
(
all
current
/
proposed
tolerances).
The
results
for
the
general
U.
S.
population
(
11%
cPAD)
and
all
related
population
subgroups
indicate
that
the
chronic
dietary
exposure
estimates
are
below
the
level
of
concern
for
HED
(<
100%
cPAD).
The
most
highly
exposed
population
subgroups
are
is
children
1­
2
years
of
age
at
28%
of
the
cPAD.
Any
refinement
of
the
current
Tier
1
chronic
dietary
exposure
assessment
using
anticipated
residues,
processing
adjustment
factors,
and
%
CT
data
would
likely
result
in
measurably
lower
dietary
risk
estimates.
Therefore,
the
addition
of
the
3
proposed
petitions
(
non­
bell
pepper,
pomegranate
and
cilantro)
to
existing
fenhexamid
tolerances
(
40
CFR
180.553)
does
not
result
in
an
unacceptable
level
of
chronic
dietary
exposure
and
risk.
IX.
List
of
Attachments
Attachment
1.
Fenhexamid
Chronic
DEEM­
FCID
 
Residue
File.
Attachment
2.
Fenhexamid
Chronic
DEEM­
FCID
 
Analysis.

cc:
W.
Carr
(
DPR),
G.
Patterson
(
DPR),
J.
Gee
(
DPR),
D.
Supkoff
(
DPR),
L.
Suguiyama
(
USEPA)
ttachment
1:
Fenhexamid
Residue
File
for
Chronic
DEEM­
FCID
 
Analysis.

U.
S.
Environmental
Protection
Agency
Ver.
2.00
DEEM­
FCID
Chronic
analysis
for
FENHEXAMID
1994­
98
data
Residue
file:
C:\
Documents
and
Settings\
jredden\
My
Documents\
ARIA\
Fenhexamid\
Fenhexamid2006\
fenhexamid
EPA
FY
06
work
share
Chronic
Tier
1
ver.
R98
Adjust.
#
2
used
Analysis
Date
05­
23­
2006
Residue
file
dated:
05­
23­
2006/
13:
03:
38/
8
Reference
dose
(
RfD)
=
0.17
mg/
kg
bw/
day
Comment:
DPR
Dietary
for
U.
S.
EPA
using
EPA
Chronic
NOAEL
/
cPAD
(
1x
S.
F.)
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
Food
Crop
Residue
Adj.
Factors
Comment
EPA
Code
Grp
Food
Name
(
ppm)
#
1
#
2
­­­­­­­­
­­­­
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
­­­­­­­­­­
­­­­­­
­­­­­­
­­­­­­­
14000030
14
Almond
0.020000
1.000
1.000
14000031
14
Almond­
babyfood
0.020000
1.000
1.000
14000040
14
Almond,
oil
0.020000
1.000
1.000
14000041
14
Almond,
oil­
babyfood
0.020000
1.000
1.000
04010050
4A
Amaranth,
leafy
30.000000
1.000
1.000
12000120
12
Apricot
10.000000
1.000
1.000
12000121
12
Apricot­
babyfood
10.000000
1.000
1.000
12000130
12
Apricot,
dried
10.000000
6.000
1.000
12000140
12
Apricot,
juice
10.000000
1.000
1.000
12000141
12
Apricot,
juice­
babyfood
10.000000
1.000
1.000
04010180
4A
Arugula
30.000000
1.000
1.000
13010550
13A
Blackberry
20.000000
1.000
1.000
13010560
13A
Blackberry,
juice
20.000000
1.000
1.000
13010561
13A
Blackberry,
juice­
babyfood
20.000000
1.000
1.000
13020570
13B
Blueberry
5.000000
1.000
1.000
13020571
13B
Blueberry­
babyfood
5.000000
1.000
1.000
13010580
13A
Boysenberry
20.000000
1.000
1.000
12000900
12
Cherry
10.000000
1.000
1.000
12000901
12
Cherry­
babyfood
10.000000
1.000
1.000
12000910
12
Cherry,
juice
10.000000
1.500
1.000
12000911
12
Cherry,
juice­
babyfood
10.000000
1.500
1.000
04011040
4A
Chrysanthemum,
garland
30.000000
1.000
1.000
19011180
19A
Coriander,
leaves
30.000000
1.000
1.000
Propos
Full
comment:
Proposed
Tolerance
FY06
(=
cilantro)
19011181
19A
Coriander,
leaves­
babyfood
30.000000
1.000
1.000
Propos
Full
comment:
Proposed
Tolerance
FY06
(=
cilantro)
19021190
19B
Coriander,
seed
30.000000
1.000
1.000
Propos
Full
comment:
Proposed
Tolerance
FY06
(=
cilantro)
19021191
19B
Coriander,
seed­
babyfood
30.000000
1.000
1.000
Propos
Full
comment:
Proposed
Tolerance
FY06
(=
cilantro)
04011330
4A
Cress,
garden
30.000000
1.000
1.000
04011340
4A
Cress,
upland
30.000000
1.000
1.000
09021350
9B
Cucumber
2.000000
1.000
1.000
13021360
13B
Currant
5.000000
1.000
1.000
13021370
13B
Currant,
dried
5.000000
4.300
1.000
Raisin
Full
comment:
Raisin
AF1
used
04011380
4A
Dandelion,
leaves
30.000000
1.000
1.000
13011420
13A
Dewberry
20.000000
1.000
1.000
08001480
8
Eggplant
2.000000
1.000
1.000
13021490
13B
Elderberry
5.000000
1.000
1.000
04011500
4A
Endive
30.000000
1.000
1.000
01011680
1AB
Ginseng,
dried
0.300000
1.000
1.000
Propos
Full
comment:
Proposed
Tolerance
FY06
13021740
13B
Gooseberry
5.000000
1.000
1.000
95001750
O
Grape
4.000000
1.000
1.000
95001760
O
Grape,
juice
4.000000
1.200
1.000
EPA
pr
Full
comment:
EPA
processing
factor
95001761
O
Grape,
juice­
babyfood
4.000000
1.200
1.000
EPA
pr
Full
comment:
EPA
processing
factor
95001770
O
Grape,
leaves
4.000000
1.000
1.000
95001780
O
Grape,
raisin
6.000000
4.500
1.000
95001790
O
Grape,
wine
and
sherry
4.000000
0.500
1.000
EPA
pr
Full
comment:
EPA
processing
factor
13021910
13B
Huckleberry
5.000000
1.000
1.000
95001950
O
Kiwifruit
15.000000
1.000
1.000
04012040
4A
Lettuce,
head
30.000000
1.000
1.000
04012050
4A
Lettuce,
leaf
30.000000
1.000
1.000
13012080
13A
Loganberry
20.000000
1.000
1.000
12002300
12
Nectarine
10.000000
1.000
1.000
08002340
8
Okra
2.000000
1.000
1.000
04012480
4A
Parsley,
leaves
30.000000
1.000
1.000
12002600
12
Peach
10.000000
1.000
1.000
12002601
12
Peach­
babyfood
10.000000
1.000
1.000
12002610
12
Peach,
dried
10.000000
7.000
1.000
12002611
12
Peach,
dried­
babyfood
10.000000
7.000
1.000
12002620
12
Peach,
juice
10.000000
1.000
1.000
12002621
12
Peach,
juice­
babyfood
10.000000
1.000
1.000
11002660
11
Pear
15.000000
1.000
1.000
11002661
11
Pear­
babyfood
15.000000
1.000
1.000
11002670
11
Pear,
dried
15.000000
6.250
1.000
11002680
11
Pear,
juice
15.000000
1.000
1.000
11002681
11
Pear,
juice­
babyfood
15.000000
1.000
1.000
08002700
8
Pepper,
bell
2.000000
1.000
1.000
08002701
8
Pepper,
bell­
babyfood
2.000000
1.000
1.000
08002710
8
Pepper,
bell,
dried
2.000000
1.000
1.000
08002711
8
Pepper,
bell,
dried­
babyfood
2.000000
1.000
1.000
08002720
8
Pepper,
nonbell
0.020000
1.000
1.000
Propos
Full
comment:
Proposed
Tolerance
FY06
08002721
8
Pepper,
nonbell­
babyfood
0.020000
1.000
1.000
Propos
Full
comment:
Proposed
Tolerance
FY06
08002730
8
Pepper,
nonbell,
dried
0.020000
1.000
1.000
Propos
Full
comment:
Proposed
Tolerance
FY06
14002820
14
Pistachio
0.020000
1.000
1.000
12002850
12
Plum
10.000000
1.000
1.000
12002851
12
Plum­
babyfood
10.000000
1.000
1.000
12002860
12
Plum,
prune,
fresh
1.500000
1.000
1.000
12002861
12
Plum,
prune,
fresh­
babyfood
1.500000
1.000
1.000
12002870
12
Plum,
prune,
dried
2.500000
5.000
1.000
12002871
12
Plum,
prune,
dried­
babyfood
2.500000
5.000
1.000
12002880
12
Plum,
prune,
juice
10.000000
1.400
1.000
12002881
12
Plum,
prune,
juice­
babyfood
10.000000
1.400
1.000
95002890
O
Pomegranate
2.000000
1.000
1.000
MRL
Re
Full
comment:
MRL
Recommends
2
ppm
(
not
3
ppm)
04013130
4A
Radicchio
30.000000
1.000
1.000
13013200
13A
Raspberry
20.000000
1.000
1.000
13013201
13A
Raspberry­
babyfood
20.000000
1.000
1.000
13013210
13A
Raspberry,
juice
20.000000
1.000
1.000
13013211
13A
Raspberry,
juice­
babyfood
20.000000
1.000
1.000
95003590
O
Strawberry
3.000000
1.000
1.000
95003591
O
Strawberry­
babyfood
3.000000
1.000
1.000
95003600
O
Strawberry,
juice
3.000000
1.000
1.000
95003601
O
Strawberry,
juice­
babyfood
3.000000
1.000
1.000
08003740
8
Tomatillo
2.000000
1.000
1.000
08003750
8
Tomato
2.000000
1.000
1.000
08003751
8
Tomato­
babyfood
2.000000
1.000
1.000
08003760
8
Tomato,
paste
2.000000
5.400
1.000
08003761
8
Tomato,
paste­
babyfood
2.000000
5.400
1.000
08003770
8
Tomato,
puree
2.000000
3.300
1.000
08003771
8
Tomato,
puree­
babyfood
2.000000
3.300
1.000
08003780
8
Tomato,
dried
2.000000
14.300
1.000
08003781
8
Tomato,
dried­
babyfood
2.000000
14.300
1.000
08003790
8
Tomato,
juice
2.000000
1.500
1.000
86010000
O
Water,
direct,
all
sources
0.001140
1.000
1.000
86020000
O
Water,
indirect,
all
sources
0.001140
1.000
1.000
Attachment
2:
Fenhexamid
Chronic
DEEM­
FCID
 
Analysis.

U.
S.
Environmental
Protection
Agency
Ver.
2.00
DEEM­
FCID
Chronic
analysis
for
FENHEXAMID
(
1994­
98
data)
Residue
file
name:
C:\
Documents
and
Settings\
jredden\
My
Documents\
ARIA\
Fenhexamid\
Fenhexamid2006\
fenhexamid
EPA
FY
06
work
share
Chronic
Tier
1
ver.
R98
Adjustment
factor
#
2
used.
Analysis
Date
05­
23­
2006/
13:
05:
02
Residue
file
dated:
05­
23­
2006/
13:
03:
38/
8
Reference
dose
(
RfD,
Chronic)
=
.17
mg/
kg
bw/
day
COMMENT
1:
DPR
Dietary
for
U.
S.
EPA
using
EPA
Chronic
NOAEL
/
cPAD
(
1x
S.
F.)
===============================================================================
Total
exposure
by
population
subgroup
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­

Total
Exposure
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
Population
mg/
kg
Percent
of
Subgroup
body
wt/
day
Rfd
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
­­­­­­­­­­­­­
­­­­­­­­­­­­­­­
U.
S.
Population
(
total)
0.018220
10.7%

U.
S.
Population
(
spring
season)
0.018244
10.7%
U.
S.
Population
(
summer
season)
0.019325
11.4%
U.
S.
Population
(
autumn
season)
0.017523
10.3%
U.
S.
Population
(
winter
season)
0.017790
10.5%

Northeast
region
0.018931
11.1%
Midwest
region
0.018870
11.1%
Southern
region
0.015993
9.4%
Western
region
0.020421
12.0%

Hispanics
0.018355
10.8%
Non­
hispanic
whites
0.018922
11.1%
Non­
hispanic
blacks
0.013802
8.1%
Non­
hisp/
non­
white/
non­
black
0.018958
11.2%

All
infants
(<
1
year)
0.035239
20.7%
Nursing
infants
0.020708
12.2%
Non­
nursing
infants
0.040755
24.0%
Children
1­
6
yrs
0.038636
22.7%
Children
7­
12
yrs
0.021627
12.7%

Females
13­
19
(
not
preg
or
nursing)
0.014725
8.7%
Females
20+
(
not
preg
or
nursing)
0.015954
9.4%
Females
13­
50
yrs
0.016213
9.5%
Females
13+
(
preg/
not
nursing)
0.016107
9.5%
Females
13+
(
nursing)
0.018157
10.7%

Males
13­
19
yrs
0.013781
8.1%
Males
20+
yrs
0.014495
8.5%
Seniors
55+
0.015503
9.1%

Children
1­
2
yrs
0.048249
28.4%
Children
3­
5
yrs
0.035835
21.1%
Children
6­
12
yrs
0.022574
13.3%
Youth
13­
19
yrs
0.014283
8.4%
Adults
20­
49
yrs
0.015135
8.9%
Adults
50+
yrs
0.015498
9.1%
Females
13­
49
yrs
0.015590
9.2%

­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­