Document ID: EPA-HQ-OPP-2004-0380-0006
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2005-02-07T05:00Z

Dimethipin
Dietary
Exposure
Assessment
DP
Barcode:
D303935
PC
Code:
118901
Page:
1
of
16
______________________________________________________________________________

UNITED
STATES
ENVIRONMENTAL
PROTECTION
AGENCY
WASHINGTON,
D.
C.
20460
OFFICE
OF
PREVENTION,
PESTICIDES
AND
TOXIC
SUBSTANCES
MEMORANDUM
DATE:
8/
18/
04
SUBJECT:
Dimethipin
Chronic
Dietary
Exposure
Assessment
for
the
Reregistration
Eligibility
Decision
PC
Code:
118901
DP
Barcode:
D303935
REVIEWER:
Susan
L.
Stanton,
Environmental
Scientist
Reregistration
Branch
3/
Health
Effects
Division
(
7509C)

THROUGH:
David
Soderberg,
Chemist
Mohsen
Sahafeyan,
Chemist
Dietary
Exposure
Science
Advisory
Council
(
DESAC)
Health
Effects
Division
(
7509C)

and
Danette
Drew,
Branch
Senior
Scientist
Branch/
Health
Effects
Division
(
7509C)

TO:
Amaris
K.
Johnson,
MPH;
Chemical
Review
Manager
Reregistration
Branch
I
SRRD
(
7508C)

Executive
Summary
A
chronic
dietary
risk
assessment
was
conducted
using
the
Lifeline
Model
Version
2.0
and
the
Dietary
Exposure
Evaluation
Model
(
DEEM­
FCID
 
,
Version
2.03)
which
use
food
consumption
data
from
the
USDA's
Continuing
Surveys
of
Food
Intakes
by
Individuals
(
CSFII)
from
1994­
1996
and
1998.
In
this
analysis
the
chronic
dietary
exposure
and
risk
estimates
resulting
from
food
intake
were
determined
for
the
general
U.
S.
population
and
various
population
subgroups.
The
analysis
was
performed
to
support
the
reregistration
eligibility
decision.
Dimethipin
Dietary
Exposure
Assessment
DP
Barcode:
D303935
PC
Code:
118901
Page:
2
of
16
______________________________________________________________________________

Chronic
Dietary
Exposure
Results
and
Characterization
The
chronic
analysis
assumed
100%
crop
treated,
DEEM
 
(
ver
7.76)
default
processing
factors,
and
tolerance­
level
residues
(
Tier
I)
for
all
commodities,
except
the
liver
of
cattle,
goats,
hogs
and
sheep.
See
section
"
II.
Residue
Information"
for
an
explanation
of
the
liver
residue
value
used
in
the
analysis.

The
resulting
food
exposure
estimates
using
the
Lifeline
 
software
were
less
than
1%
of
the
cPAD
for
the
U.
S.
population
and
all
population
subgroups.
Dimethipin
food
exposure
was
estimated
at
0.000042
mg/
kg/
day
for
the
U.
S.
population
(<
1%
of
the
cPAD)
and
0.000083
mg/
kg/
day
(<
1%
of
the
cPAD)
for
the
most
highly
exposed
population
subgroup
(
children,
3­
5
years
old).
DEEM­
FCID
yielded
similar
results.

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
(
i.
e.,
the
dose
which
HED
has
concluded
will
result
in
no
unreasonable
adverse
health
effects).
This
dose
is
referred
to
as
the
chronic
population
adjusted
dose
(
cPAD).
The
cPAD
is
equivalent
to
the
Reference
Dose
(
RfD)
divided
by
the
special
FQPA
Safety
Factor.

For
non­
cancer
chronic
exposures,
HED
is
concerned
when
estimated
dietary
risk
exceeds
100%
of
the
cPAD.
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).

This
document
represents
the
first
dietary
risk
assessment
for
dimethipin
conducted
by
HED
since
July
7,
1989,
when
an
assessment
was
conducted
using
the
Tolerance
Assessment
System
(
TAS)
software.
The
TAS
anaylsis
evaluated
the
same
tolerances
and
provided
results
that
were
similar
to
the
results
of
the
current
analyses
(
i.
e.,
exposures
less
than
1%
of
the
reference
dose
for
the
U.
S.
population
and
all
population
subgroups).

II.
Residue
Information
Residues
of
Concern
in
Plants
and
Livestock:
The
dimethipin
review
team
met
on
March
11,
2004
and
May
17,
2004
and
determined
that
the
residue
of
concern
for
purposes
of
tolerance
enforcement
in
plants
and
livestock
commodities
is
dimethipin
per
se.
The
residue
of
concern
for
purposes
of
risk
assessment
is
dimethipin
per
se
in
all
plants
and
livestock
commodities,
except
the
liver
of
cattle,
goats,
hogs
and
sheep.
The
residues
of
concern
for
risk
assessment
in
liver
are
dimethipin
and
its
metabolite
acetyl
dithiane
tetraoxide
(
Dimethipin
Team
Review
of
Metabolism
Information,
3/
11/
04
and
5/
17/
04
meetings).
Dimethipin
Dietary
Exposure
Assessment
DP
Barcode:
D303935
PC
Code:
118901
Page:
3
of
16
______________________________________________________________________________

Tolerances:
The
tolerances
listed
in
40
CFR
§
180.406(
a)
are
expressed
in
terms
of
dimethipin
(
2,3­
dihydro­
5,6­
dimethyl­
1,4­
dithiin
1,1,4,4­
tetraoxide;
CAS
Reg.
No.
55290­
64­
7)
per
se.
The
current
tolerance
expression
is
adequate.
The
current
tolerances
and
reassessed
tolerances
for
dimethipin
are
summarized
in
Table
1.

Table
1.
Tolerance
Reassessment
Summary
for
Dimethipin.

Commodity
Current
Tolerance
(
ppm)
Range
of
Residues
(
ppm)
Tolerance
Reassessment
(
ppm)
Comments
Tolerances
Listed
Under
40
CFR
§
180.406(
a)
1:

Cotton,
undelinted
seed
0.5
<
0.10­
0.260
0.5
Cotton,
hulls
0.7
average
processing
factor
=
0.95x
Revoke
No
tolerance
for
cotton
hulls
is
necessary
because
residues
do
not
concentrate.

Cattle,
fat
0.02
<
0.01
at
a
10x
dosing
level
Revoke
The
available
feeding
study
data,
reflecting
exaggerated
dosing
levels,
indicate
that
there
is
no
expectation
of
finite
residues.
However,
tolerances
for
meat
and
meat
byproducts
are
being
retained
for
the
purpose
of
international
harmonization
with
CODEX,
which
has
established
tolerances
of
0.02
ppm
for
residues
of
dimethipin,
per
se,
on
meat
and
edible
offal
(
mammalian).
There
are
no
CODEX
MRLs
for
fat.
Cattle,
meat
0.02
0.02
Cattle,
meat
byproducts
0.02
0.02
Goat,
fat
0.02
Revoke
Goat,
meat
0.02
0.02
Goat,
meat
byproducts
0.02
0.02
Hog,
fat
0.02
Revoke
Hog,
meat
0.02
0.02
Hog,
meat
byproducts
0.02
0.02
Horse,
fat
0.02
Revoke
Horse,
meat
0.02
0.02
Horse,
meat
byproducts
0.02
0.02
Sheep,
fat
0.02
Revoke
Sheep,
meat
0.02
0.02
Sheep,
meat
byproducts
0.02
0.02
Tolerances
to
Be
Proposed
under
40
CFR
180.406(
a):

Cotton,
gin
byproducts
­­
­­
TBD2
1There
are
no
tolerances
established
for
milk
and
poultry
commodities
and
none
are
required
since
residues
are
not
expected
in
these
commodities.
2TBD
=
To
be
determined.
Additional
residue
crop
field
trial
data
are
required.

Residues
used
in
the
Chronic
Analysis:
The
chronic
analysis
assumed
100%
crop
treated,
DEEM
 
(
ver
7.76)
default
processing
factors,
and
tolerance­
level
residues
for
all
commodities,
except
the
liver
of
cattle,
goats,
hogs
and
sheep.
Tolerances
for
fat
were
included,
even
though
HED
is
recommending
that
tolerances
for
livestock
fat
be
revoked.

Liver:
The
residues
of
concern
for
risk
assessment
in
liver
are
dimethipin
and
its
metabolite,
acetyl
dithiane
tetraoxide.
A
conservative
residue
value
for
liver
was
calculated
by
multiplying
the
Dimethipin
Dietary
Exposure
Assessment
DP
Barcode:
D303935
PC
Code:
118901
Page:
4
of
16
______________________________________________________________________________

total
amount
of
dimethipin
and
acetyl
dithiane
tetraoxide
(
0.0
ppm
dimethipin
and
0.045
ppm)
found
in
the
liver
in
the
ruminant
metabolism
study
at
1/
2x
the
maximum
theoretical
dietary
burden
(
MTDB)
for
cattle
by
2
and
rounding
to
0.1
ppm
(
0.045
ppm
x
2
=
0.09,
rounded
to
0.1ppm).
This
value
is
considered
conservative
because
of
the
worst­
case
assumptions
that
went
into
calculation
of
the
MTDB
for
cattle.
Residue
data
for
the
cattle
feed
item,
cotton
gin
byproducts,
have
not
been
submitted;
however,
it
is
unlikely
that
residues
of
dimethipin
in
cotton
gin
byproducts
would
exceed
residues
in
cotton
seed
by
more
than
a
factor
of
50X.
A
review
of
existing
tolerances
for
13
pesticides
with
both
cotton
seed
and
cotton
gin
byproducts
tolerances
found
a
1X
to
50X
difference
between
cotton
seed
and
cotton
gin
byproducts
tolerances
with
an
average
difference
of
22X.
Based
on
this
information,
the
MTDB
of
dimethipin
to
cattle
was
calculated
assuming
a
worst­
case
estimate
of
residues
of
dimethipin
in/
on
cotton
gin
byproducts
at
25
ppm,
equivalent
to
50X
the
cotton
seed
tolerance
of
0.5
ppm
(
Dimethipin.
Residue
Chemistry
Considerations
for
Reregistration
Eligibility
Decision.
Case
No.
3063.
DP293580.
Danette
Drew.
7/
22/
04).
The
MTDB
of
dimethipin
to
cattle
is
also
considered
conservative,
because
it
assumes
cotton
gin
byproducts
would
comprise
20%
of
the
diet
of
all
beef
and
dairy
cattle.
In
fact,
cotton
gin
byproducts
is
a
relatively
minor
feed
item
of
significance
in
certain
regional
areas
only
(
e.
g.,
Texas).
In
most
areas,
cotton
gin
byproducts
would
be
a
minor
contributor
or
noncontributor
to
the
diet
of
beef
and
dairy
cattle.
This
is
especially
true
for
dimethipin,
since
less
than
5%
of
the
cotton
crop
is
treated.
It
should
be
noted
that
HED
is
currently
reviewing
public
comments
regarding
the
feeding
of
cotton
gin
byproducts
to
livestock
and
may
revise
(
i.
e.,
lower)
its
estimate
of
the
maximum
amount
in
livestock
diets
in
the
future.

The
data
and
residue
estimates
used
in
the
chronic
analysis
are
summarized
in
Table
2.
As
noted
above,
data
on
the
magnitude
of
the
residue
in
cotton
gin
byproducts
are
outstanding.
Once
these
data
are
submitted
and
reviewed,
they
could
be
used
to
refine
the
residue
estimates
for
livestock
commodities,
including
liver.
Dimethipin
Dietary
Exposure
Assessment
DP
Barcode:
D303935
PC
Code:
118901
Page:
5
of
16
______________________________________________________________________________

Table
2.
Data
and
Residue
Estimates
Used
in
Dietary
Analyses
Commodity
Food
Forms
Data
Source
%
CT
Processing
Factor
Residue
(
ppm)

Cotton
seed
oil
Tolerance
100
1.00
0.5
oil­
babyfood
Tolerance
100
1.00
0.02
Beef
meat
Tolerance
100
1.00
0.02
meat­
babyfood
Tolerance
100
1.00
0.02
meat,
dried
Tolerance
100
1.92
0.02
meat
byproducts
Tolerance
100
1.00
0.02
meat
byproducts,
babyfood
Tolerance
100
1.00
0.02
fat
Tolerance
100
1.00
0.02
fat­
babyfood
Tolerance
100
1.00
0.02
kidney
Tolerance
100
1.00
0.02
liver
Ruminant
Metabolism
Data
100
1.0
0.1
liver­
babyfood
Ruminant
Metabolism
Data
100
1.0
0.1
Goat
meat
Tolerance
100
1.00
0.02
meat
byproducts
Tolerance
100
1.00
0.02
fat
Tolerance
100
1.00
0.02
kidney
Tolerance
100
1.00
0.02
liver
Ruminant
Metabolism
Data
100
1.0
0.1
Horse
meat
Tolerance
100
1.00
0.02
Pork
meat
Tolerance
100
1.00
0.02
meat­
babyfood
Tolerance
100
1.00
0.02
skin
Tolerance
100
1.00
0.02
meat
byproducts
Tolerance
100
1.00
0.02
meat
byproducts­
babyfood
Tolerance
100
1.00
0.02
fat
Tolerance
100
1.00
0.02
fat­
babyfood
Tolerance
100
1.00
0.02
kidney
Tolerance
100
1.00
0.02
liver
Ruminant
Metabolism
Data
100
1.0
0.1
Sheep
meat
Tolerance
100
1.00
0.02
Dimethipin
Dietary
Exposure
Assessment
DP
Barcode:
D303935
PC
Code:
118901
Page:
6
of
16
______________________________________________________________________________

Commodity
Food
Forms
Data
Source
%
CT
Processing
Factor
Residue
(
ppm)

meat­
babyfood
Tolerance
100
1.00
0.02
meat
byproducts
Tolerance
100
1.00
0.02
fat
Tolerance
100
1.00
0.02
fat­
babyfood
Tolerance
100
1.00
0.02
kidney
Tolerance
100
1.00
0.02
liver
Ruminant
Metabolism
Data
100
1.0
0.1
III
Program
and
Consumption
Information
Several
reasonable,
peer­
reviewed
softwares
have
recently
been
emerging
for
modeling
dietary
exposure
to
pesticides.
For
a
variety
of
technical,
historical,
and
availability
reasons,
DEEMTM
was
the
program
generally
used
by
EPA's
Office
of
Pesticide
Programs
for
conducting
its
dietary
risk
assessments.
With
the
advent
and
current
availability
of
a
number
of
other
exposure
software
programs,
OPP,
registrants,
and
other
interested
parties
have
available
to
them
the
option
of
selecting
other
peer­
reviewed
exposure
software
in
conducting
risk
assessments
for
pesticides.
LifelineTM
is
one
such
model
and
is
the
software
being
used
in
this
HED
review.
Dietary
Exposure
assessments
may
also
be
performed
with
other,
similar
programs,
and
if
submitted,
such
results
will
be
reviewed
by
EPA
for
acceptability
and
comparability
to
existing
peer­
reviewed
software
being
used
by
OPP.

III
a.
Lifeline
 
Program
and
Consumption
Information
A
chronic
dietary
exposure
estimate
was
conducted
using
the
Lifeline
 
model
(
Version
2.0),
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.
Lifeline
 
uses
the
recipe
file
contained
within
the
program
to
relate
raw
agricultural
commodities
(
RACs)
to
foods
"
as­
eaten."
Lifeline
 
converts
the
RAC
residues
into
food
residues
by
randomly
selecting
a
RAC
residue
value
from
the
"
user
defined"
residue
distribution
(
created
from
the
residue,
percent
crop
treated,
and
processing
factors
data),
and
calculating
a
net
residue
for
that
food
based
on
the
ingredients'
mass
contribution
to
that
food
item.
For
example,
`
apple
pie'
will
have
a
residue
distribution
based
on
the
residues
provided
for
apples
(
adjusted
by
the
appropriate
processing
factors
and
percent
crop
treated),
as
well
as
the
residues
for
each
of
the
other
ingredients
in
the
apple
pie
recipe
for
which
there
may
be
tolerances.
Lifeline
 
calculates
dietary
exposure
from
`
apple
pie'
based
on
the
amount
eaten,
and
the
residue
drawn
from
the
`
apple
pie'
residue
distribution
for
that
eating
occasion.
Dimethipin
Dietary
Exposure
Assessment
DP
Barcode:
D303935
PC
Code:
118901
Page:
7
of
16
______________________________________________________________________________

Lifeline
 
models
the
individual's
dietary
exposures
over
a
season
by
selecting
a
new
CSFII
diary
each
day
from
a
set
of
similar
individuals
based
on
age
and
season
attributes.
Lifeline
 
groups
CSFII
diaries
based
on
the
respondents'
age
and
the
season
during
which
the
food
diary
was
recorded.
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.
Further
information
regarding
the
Lifeline
 
model
can
be
found
at
the
following
web
site:
www.
theLifeline
 
group.
org.

III
b.
DEEM­
FCID
 
Program
and
Consumption
Information
A
chronic
dietary
exposure
assessment
was
also
conducted
for
dimethipin
using
DEEM­
FCID
 
,
Version
2.03.
This
DEEM­
FCID
assessment
was
conducted
using
the
same
consumption
data
as
the
Lifeline
 
model
(
CSFII,
1994­
1996
and
1998).
In
the
DEEM­
FCID
program,
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.

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
Dimethipin
is
a
relatively
low
toxicity
chemical
with
a
chronic
RfD
(
and
cPAD)
of
0.0218
mg/
kg/
day.
The
RfD
is
based
on
the
NOAEL
of
2.18
mg/
kg
from
a
combined
chronic
toxicity/
carcinogenicity
feeding
study
in
the
rat
and
a
100­
fold
inter­/
intra­
species
uncertainty
factor.
The
FQPA
safety
factor
has
been
reduced
to
1x,
based
on
the
following
considerations:

°
No
evidence
of
increased
quantitative
or
qualitative
susceptibility
in
the
available
studies.
°
Clear
NOAELs/
LOAELs
have
been
identified
for
the
critical
effect.
°
Dose­
response
relationships
for
the
critical
effects
are
well­
characterized.
°
The
degree
of
concern
is
low
and
there
are
no
residual
uncertainties
for
Pre
and/
or
Post­
natal
Susceptibility.
Dimethipin
Dietary
Exposure
Assessment
DP
Barcode:
D303935
PC
Code:
118901
Page:
8
of
16
______________________________________________________________________________

An
endpoint
of
concern
attributable
to
a
single
dose
was
not
identified
for
dimethipin;
therefore,
an
acute
RfD
was
not
established.

Dimethipin
was
classified
as
a
tentative
Group
C
(
possible
human)
carcinogen
by
the
HED
Peer
Review
Committee
(
January
5,
1990;
PR
7753).
The
classification
was
tentative
and
a
decision
regarding
quantification
of
the
risk
was
deferred,
pending
submission
of
an
adequate
rat
carcinogenicity
study.
Results
of
the
new
rat
study
confirmed
the
Group
C
classification.
Quantification
of
the
cancer
risk
is
not
recommended.

SUMMARY
OF
TOXICOLOGY
ENDPOINT
SELECTION
Table
3.
Summary
of
Toxicological
Doses
and
Endpoints
for
Dimethipin
for
Use
in
Human
Dietary
Risk
Assessment
Exposure
Scenario
Dose
(
mg/
kg/
day)
UF
/
MOE
Hazard
Based
Special
FQPA
Safety
Factor
Endpoint
for
Risk
Assessment
Acute
Dietary
females
13­
50
years
of
age
Acute
RfD
=

Not
applicable.
Not
applicable.
An
endpoint
of
concern
attributable
to
a
single
dose
was
not
identified.
An
acute
RfD
was
not
established.

Acute
Dietary
general
population
including
infants
and
children
Acute
RfD
=
Not
applicable.
Not
applicable.
An
endpoint
of
concern
attributable
to
a
single
dose
was
not
identified.
An
acute
RfD
was
not
established.

Chronic
Dietary
all
populations
NOAEL
=
2.18
mg/
kg/
day
UF
=
100
Chronic
RfD
=
0.0218
mg/
kg/
day
1X
(
cRfD/
FQPA
SF
=
cPAD
=
0.0218/
1
=
0.0218)
ChronicToxicity/
Carcinogenicity
Study
in
the
Rat
LOAEL
=
50.3
mg/
kg/
day
,
based
on
toxicity
in
the
kidney,
lungs,
duodenum,
and
testes
of
male
rats
and
depressed
body
weight
gain
and
toxicity
in
the
liver,
kidney,
glandular
stomach,
heart,
and
aortic
artery
of
female
rats.
mg/
kg/
day
based
in
females.

Cancer
Classification:
Class
C
­
quantification
not
recommended.
Dimethipin
Dietary
Exposure
Assessment
DP
Barcode:
D303935
PC
Code:
118901
Page:
9
of
16
______________________________________________________________________________

V.
Results/
Discussion
As
stated
above,
for
a
chronic
assessment,
HED
is
concerned
when
dietary
risk
exceeds
100%
of
the
cPAD.
The
Lifeline
 
analysis
estimates
the
dietary
exposure
of
the
U.
S.
population
and
various
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,
youth
13­
19,
females
13­
49,
adults
20­
49,
and
adults
50+
years.
The
Lifeline
 
chronic
dietary
exposure
estimate
is
based
on
an
average
daily
exposure
from
a
profile
of
1000
individuals
over
a
one
year
period.
The
dietary
exposure
estimates
using
the
Lifeline
software
were
less
than
1.0%
of
the
cPAD
for
the
U.
S.
population
and
each
of
the
population
subgroups.
Dimethipin
food
exposure
was
estimated
at
0.000042
mg/
kg/
day
for
the
U.
S.
population
(<
1%
of
the
cPAD)
and
0.000083
mg/
kg/
day
(<
1%
of
the
cPAD)
for
the
most
highly
exposed
population
subgroup
(
children,
3­
5
years
old).

Chronic
dietary
risks
were
also
estimated
using
the
DEEM­
FCID
 
model
(
version
2.03).
Results
of
the
DEEM­
FCID
 
analysis
are
fully
consistent
with
the
Lifeline
 
results.
The
DEEM­
FCID
 
chronic
dietary
exposure
estimate
for
children,
3­
5
years
old,
is
0.000085
mg/
kg/
day,
equivalent
to
<
1%
of
the
cPAD.

Table
4:
Summary
of
Chronic
Dietary
Exposure
and
Risk
for
Dimethipin
Population
Subgroup
cPAD
(
mg/
kg/
day)
Exposure
(
mg/
kg/
day)
%
cPAD
Lifeline
DEEMFCID
Lifeline
DEEM­
FCID
General
U.
S.
Population
0.0218
0.000042
0.000040
<
1.0
<
1.0
All
Infants
(<
1
year
old)
0.000015
0.000015
<
1.0
<
1.0
Children
1­
2
years
old
0.000076
0.000078
<
1.0
<
1.0
Children
3­
5
years
old
0.000083
0.000085
<
1.0
<
1.0
Children
6­
12
years
old
0.000060
0.000062
<
1.0
<
1.0
Youth
13­
19
years
old
0.000043
0.000043
<
1.0
<
1.0
Adults
20­
49
years
old
0.000038
0.000035
<
1.0
<
1.0
Adults
50+
years
old
0.000037
0.000027
<
1.0
<
1.0
Females
13­
49
years
old
0.000043
0.000031
<
1.0
<
1.0
VI.
Characterization
of
Inputs/
Outputs
These
chronic
dietary
exposure
and
risk
estimates
are
conservative
since
they
assumed
100%
crop
treated,
DEEM
 
(
ver
7.76)
default
processing
factors,
and
tolerance­
level
residues
for
all
commodities,
except
liver.
The
chronic
analysis
could
be
further
refined
through
the
use
of
anticipated
residues
for
livestock
commodities,
average
residues
for
cottonseed
based
on
field
trial
data,
percent
crop
treated
data
and/
or
preparation/
cooking
factors.
Dimethipin
Dietary
Exposure
Assessment
DP
Barcode:
D303935
PC
Code:
118901
Page:
10
of
16
______________________________________________________________________________

VII.
Conclusions
A
chronic
dietary
risk
assessment
was
conducted
using
the
Lifeline
 
(
ver.
2.00)
and
DEEMFCID
 
(
ver.
2.03)
models.
The
analyses
assumed
100%
crop
treated,
DEEM
 
(
ver
7.76)
default
processing
factors,
and
tolerance­
level
residues
for
all
commodities,
except
liver.
The
resulting
dietary
risk
estimates
(<
1%
of
the
cPAD)
were
less
than
HED's
level
of
concern
(
100%
cPAD);
children
3­
5
years
old
were
the
most
highly
exposed
population
with
an
estimated
exposure
of
0.000083
mg/
kg/
day
(<
1%
of
the
cPAD).
Lifeline
and
DEEM­
FCID
yielded
comparable
results.

VIII.
List
of
Attachments
°
Attachment
1:
LifeLine
Chronic
Food
Residue
Input
File.
°
Attachment
2:
LifeLine
Chronic
Results
File.
°
Attachment
3:
DEEM­
FCID
Chronic
Food
Residue
Input
File.
°
Attachment
4:
DEEM­
FCID
Chronic
Results
File.

cc:
Susan
Stanton,
John
Liccione,
Danette
Drew
S.
L.
Stanton:
821B:
CM#
2:(
703)
305­
5218:
7509C:
RRB3
Page
11
of
16
Attachment
1:
LifeLine
Chronic
Food
Residue
Input
File.

Annual
Cod
Crop
Group
Code
Commodity
FoodForm
Residue
Dehydratio
Washing
Heating
Refining
Storage
Other
Use
21
BEEF
000441
Beef,
meat­
All
.02
21
BEEF
000450
Beef,
meat,
dried
All
.02
1.92
21
BEEF
000460
Beef,
meat
All
.02
21
BEEF
000461
Beef,
meat
All
.02
21
BEEF
000470
Beef,
fat
All
.02
21
BEEF
000471
Beef,
fat­
babyfood
All
.02
21
BEEF
000480
Beef,
kidney
All
.02
21
BEEF
000490
Beef,
liver
All
.1
21
BEEF
000491
Beef,
liver­
All
.1
21
BEEF
000440
Beef,
meat
All
.02
23
GOAT
001700
Goat,
meat
All
.02
23
GOAT
001710
Goat,
fat
All
.02
23
GOAT
001720
Goat,
kidney
All
.02
23
GOAT
001730
Goat,
liver
All
.1
23
GOAT
001690
Goat,
meat
All
.02
24
HORSE
001890
Horse,
meat
All
.02
25
PORK
002901
Pork,
meat­
All
.02
25
PORK
002910
Pork,
skin
All
.02
25
PORK
002920
Pork,
meat
All
.02
25
PORK
002921
Pork,
meat
All
.02
25
PORK
002930
Pork,
fat
All
.02
25
PORK
002931
Pork,
fat­
babyfood
All
.02
Page
12
of
16
25
PORK
002940
Pork,
kidney
All
.02
25
PORK
002950
Pork,
liver
All
.1
25
PORK
002900
Pork,
meat
All
.02
26
SHEEP
003391
Sheep,
meat­
All
.02
26
SHEEP
003400
Sheep,
meat
All
.02
26
SHEEP
003410
Sheep,
fat
All
.02
26
SHEEP
003411
Sheep,
fat­
All
.02
26
SHEEP
003420
Sheep,
kidney
All
.02
26
SHEEP
003430
Sheep,
liver
All
.1
26
SHEEP
003390
Sheep,
meat
All
.02
95
MISC.
001280
Cottonseed,
oil
All
0.5
95
MISC.
001281
Cottonseed,
oil
­
All
0.5
Page
13
of
16
Attachment
2:
LifeLine
Chronic
Results
File.

age_
group
person_
years
mean
cPAD_
mean
NOAEL
UFFQPA
cPAD
General
U.
S.
Population
86000
0.000042
0.2
2.18
100
0.0218
All
Infants
(<
1
year
old)
1000
0.000015
0.1
2.18
100
0.0218
Children
1­
2
years
old
2000
0.000076
0.3
2.18
100
0.0218
Children
3­
5
years
old
3000
0.000083
0.4
2.18
100
0.0218
Children
6­
12
years
old
7000
0.000060
0.3
2.18
100
0.0218
Youth
13­
19
years
old
7000
0.000043
0.2
2.18
100
0.0218
Adults
20­
49
years
old
30000
0.000038
0.2
2.18
100
0.0218
Adults
50+
years
old
36000
0.000037
0.2
2.18
100
0.0218
Females
13­
49
years
old
18648
0.000043
0.2
2.18
100
0.0218
Page
14
of
16
Attachment
3:
DEEM­
FCID
Chronic
Food
Residue
Input
File.

Filename:
C:\
DEEMFiles\
dimethipin\
dimethipinwithmeatmilk.
R98
Chemical:
Dimethipin
RfD(
Chronic):
.0218
mg/
kg
bw/
day
NOEL(
Chronic):
2.18
mg/
kg
bw/
day
RfD(
Acute):
0
mg/
kg
bw/
day
NOEL(
Acute):
0
mg/
kg
bw/
day
Date
created/
last
modified:
04­
08­
2004/
15:
44:
53/
8
Program
ver.
2.03
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
EPA
Crop
Def
Res
Adj.
Factors
Comment
Code
Grp
Commodity
Name
(
ppm)
#
1
#
2
­­­­­­­­
­­­­
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
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
0.020000
1.000
1.000
21000471
M
Beef,
fat­
babyfood
0.020000
1.000
1.000
21000480
M
Beef,
kidney
0.020000
1.000
1.000
21000490
M
Beef,
liver
0.100000
1.000
1.000
21000491
M
Beef,
liver­
babyfood
0.100000
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
0.020000
1.000
1.000
23001720
M
Goat,
kidney
0.020000
1.000
1.000
23001730
M
Goat,
liver
0.100000
1.000
1.000
24001890
M
Horse,
meat
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
0.020000
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
0.020000
1.000
1.000
25002931
M
Pork,
fat­
babyfood
0.020000
1.000
1.000
25002940
M
Pork,
kidney
0.020000
1.000
1.000
25002950
M
Pork,
liver
0.100000
1.000
1.000
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
0.020000
1.000
1.000
26003411
M
Sheep,
fat­
babyfood
0.020000
1.000
1.000
26003420
M
Sheep,
kidney
0.020000
1.000
1.000
26003430
M
Sheep,
liver
0.100000
1.000
1.000
95001280
O
Cottonseed,
oil
0.500000
1.000
1.000
95001281
O
Cottonseed,
oil­
babyfood
0.500000
1.000
1.000
Page
15
of
16
Attachment
4:
DEEM­
FCID
Chronic
Results
File.

U.
S.
Environmental
Protection
Agency
Ver.
2.00
DEEM­
FCID
Chronic
analysis
for
DIMETHIPIN
(
1994­
98
data)
Residue
file
name:
C:\
DEEMResFiles\
dimethipin\
dimethipinwithmeatmilk.
R98
Adjustment
factor
#
2
NOT
used.
Analysis
Date
04­
09­
2004/
09:
41:
03
Residue
file
dated:
04­
08­
2004/
15:
44:
53/
8
Reference
dose
(
RfD,
Chronic)
=
.0218
mg/
kg
bw/
day
COMMENT
1:
Chronic
analysis
with
tolerance
level
residues
(
except
liver
at
0.1
ppm),
100%
CT
and
default
processing
factors.
===============================================================================
Total
exposure
by
population
subgroup
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­

Total
Exposure
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
Population
mg/
kg
Percent
of
Subgroup
body
wt/
day
Rfd
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
­­­­­­­­­­­­­
­­­­­­­­­­­­­­­
U.
S.
Population
(
total)
0.000040
0.2%

U.
S.
Population
(
spring
season)
0.000040
0.2%
U.
S.
Population
(
summer
season)
0.000041
0.2%
U.
S.
Population
(
autumn
season)
0.000040
0.2%
U.
S.
Population
(
winter
season)
0.000040
0.2%

Northeast
region
0.000037
0.2%
Midwest
region
0.000044
0.2%
Southern
region
0.000040
0.2%
Western
region
0.000039
0.2%

Hispanics
0.000043
0.2%
Non­
hispanic
whites
0.000038
0.2%
Non­
hispanic
blacks
0.000048
0.2%
Non­
hisp/
non­
white/
non­
black
0.000045
0.2%

All
infants
(<
1
year)
0.000015
0.1%
Nursing
infants
0.000006
0.0%
Non­
nursing
infants
0.000018
0.1%
Children
1­
6
yrs
0.000081
0.4%
Children
7­
12
yrs
0.000060
0.3%

Females
13­
19
(
not
preg
or
nursing)
0.000036
0.2%
Females
20+
(
not
preg
or
nursing)
0.000027
0.1%
Page
16
of
16
Females
13­
50
yrs
0.000033
0.1%
Females
13+
(
preg/
not
nursing)
0.000034
0.2%
Females
13+
(
nursing)
0.000035
0.2%
Males
13­
19
yrs
0.000051
0.2%
Males
20+
yrs
0.000038
0.2%
Seniors
55+
0.000026
0.1%

Children
1­
2
yrs
0.000078
0.4%
Children
3­
5
yrs
0.000085
0.4%
Children
6­
12
yrs
0.000062
0.3%
Youth
13­
19
yrs
0.000043
0.2%
Adults
20­
49
yrs
0.000035
0.2%
Adults
50+
yrs
0.000027
0.1%
Females
13­
49
yrs
0.000031
0.1%

­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­