Document ID: EPA-HQ-OPP-2004-0048-0009
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2004-06-18T04:00Z

Amitraz
Dietary
Exposure
Assessment
DP
Number:
D300300
PC
Code:
106201
Page:
1
of
20
UNITED
STATES
ENVIRONMENTAL
PROTECTION
AGENCY
WASHINGTON,
D.
C.
20460
OFFICE
OF
PREVENTION,
PESTICIDES
AND
TOXIC
SUBSTANCES
MEMORANDUM
DATE:
4/
30/
2004
SUBJECT:
Amitraz.
Acute,
Probabilistic,
Chronic,
and
Cancer
Dietary
Exposure
Assessments
for
the
Tolerance
Reassessment
Eligibility
Decision
(
TRED)
Document.

PC
Code:
106201
DP
Number:
D300300
REVIEWER:
José
J.
Morales,
Chemist
Reregistration
Branch
3/
Health
Effects
Division
(
HED,
7509C)

THROUGH:
Sheila
Piper,
Chemist
Dave
Soderberg,
Chemist
Dietary
Exposure
Science
Advisory
Council
(
DESAC)
HED
(
7509C)

and
Danette
Drew,
Branch
Senior
Scientist
Branch/
HED
(
7509C)

TO:
John
Pates,
Chemical
Review
Manager
Reregistration
Branch
1
Special
Review
and
Reregistration
Division
(
7508C)

Executive
Summary
Amitraz
Dietary
Exposure
Assessment
DP
Number:
D300300
PC
Code:
106201
Page:
2
of
20
Refined
probabilistic
acute,
chronic,
and
cancer
dietary
risk
assessments
were
conducted
using
DEEM­
FCID
 
(
Version
1.30)
and
the
Lifeline
 
Model
(
Version
2.0)
which
uses
food
consumption
data
from
the
United
States
Department
of
Agriculture's
(
USDA's).
Continuing
Surveys
of
Food
Intakes
by
Individuals
(
CSFII)
from
1994­
1996
and
1998.
Chronic
and
acute
exposure
estimates
were
based
on
data
from
dermal
metabolism
studies
provided
by
the
registrant
and
percent
crop
treated
provided
by
BEAD.
Conservative
assumptions
were
made
in
the
calculation
of
anticipated
residues
used
in
the
dietary
assessment.
The
analyses
were
performed
to
support
the
tolerance
reassessment
eligibility
decision
document.

Acute
Dietary
Exposure
Results
and
Characterization
Acute
dietary
risks,
using
Lifeline
 
Model,
are
above
HED's
level
of
concern
for
children
1­
2
yrs
(
186%
of
aPAD,
0.000465
mg/
kg/
day)
and
children
3­
5
years
old
(
170%
of
aPAD,
0.000425
mg/
kg/
day)
at
the
99.9th
percentile
of
exposure.

Acute
dietary
risks,
using
DEEM­
FCID
 
,
are
above
HED's
level
of
concern
for
children
1­
2
yrs
(
140%
of
aPAD,
0.000349
mg/
kg/
day)
at
the
99.9th
percentile
of
exposure.

As
noted
in
this
risk
assessment,
DEEM
 
and
Lifeline
 
provided
different
predicted
exposure
at
the
99.9th
percentiles
for
the
1
to
2
and
3
to
5
year
old
subpopulations
(
both
exceeding
the
aPAD).
The
assessment
accounts
for
exposure
from
the
three
RACs:
beef,
pork
and
milk.
Milk
is
the
primary
RAC
that
drives
exposure
at
the
99.9th
percentile
due
to
the
relatively
high
residues.
Lifeline
had
relatively
higher
predictions
for
both
the
1
to
2
year
old
(
186%
vs
140%
aPAD),
and
3
to
5
year
old
subpopulations
(
170%
vs
94%
aPAD).
The
different
model
predictions
can
be
attributed
to
two
reasons:
(
1)
a
limitation
regarding
the
Lifeline
software,
and
(
2)
modeling
differences
between
DEEM
 
and
Lifeline
 
.
A
complete
explanation
of
how
these
factors
affect
the
model
predictions
will
be
presented
in
a
subsequent
memo.
The
apparent
limitation
in
Lifeline
 
software
is
the
result
of
several
concurrent
factors:
(
i)
milk
is
treated
as
a
food
comprised
of
three
RACS
(
water,
non­
fat
solids,
fat),
(
ii)
the
percent
crop
treated
is
relatively
low
(
0.1%),
and
(
iii)
the
Lifeline
 
Food
Residue
Translator
(
FRT)
approximates
food
(
milk)
residue
percentiles
based
on
a
fixed
number
of
simulations.
The
difference
in
modeling
design
(
frequency
of
using
food
diaries
and
weights
applied)
also
contribute
towards
the
Lifeline
 
model
providing
higher
exposure
estimates
than
DEEM
 
.
This
latter
effect
is
independent
of
the
first
effect,
however,
it
is
also
dependent
upon
the
percent
crop
treated
value
used
for
milk.

Given
the
relatively
high
anticipated
residues
for
milk
(
0.03
ppm),
a
moderate
amount
of
milk
consumption
may
provide
exposure
exceeding
the
aPAD.
For
example,
a
20
kg
toddler
(
typical
5
year
old),
consuming
8
ounces
of
milk
(
226
grams
=
8
x
28.3
grams/
oz),
or
equivalently,
11.3
grams/
kg
bwt/
day
(~
226/
20),
would
have
dietary
exposure
of
approximately
0.0003
mg
ai/
kg
bwt/
day
(=
0.03
ppm
x
11.3
gm/
kg
bwt/
day
x
(
1/
1000)),
or
135%
of
the
aPAD
(=
0.00025).
The
average
milk
consumption
for
1­
4
year
olds
is
approximately
337
gm/
day,
with
75%
of
toddlers
Amitraz
Dietary
Exposure
Assessment
DP
Number:
D300300
PC
Code:
106201
Page:
3
of
20
(
1to5
year
olds)
consuming
11
grams/
kg
bwt/
day
or
more
of
dairy
products.
Even
though
the
other
two
commodities
(
beef,
pork)
provide
relatively
low
exposure,
milk
continues
to
provide
exposure
at
the
99.9th
percentile
even
with
the
low
percent
crop
treated
due
to
the
application
of
residues
to
the
three
milk
components
(
water,
fat,
non­
fat
solids),
and
the
relatively
high
percent
of
toddlers
that
consume
milk.

Chronic
and
Cancer
Dietary
Exposure
Results
and
Characterization
Estimated
chronic
dietary
risk
is
below
HED's
level
of
concern
for
all
populations
(<
1%
of
cPAD).
Results
of
the
Lifeline
 
analysis
are
fully
consistent
with
DEEM­
FCID
 
results.
The
estimated
exposure
of
the
general
U.
S.
population
to
amitraz
is
<
0.000001
mg/
kg/
day
for
both
dietary
risk
assessment
models.
Applying
the
Q
1*
of
2.83
x
10­
2
(
mg/
kg/
day)­
1
to
the
exposure
value
results
in
a
cancer
risk
estimate
of
2.8
x
10­
8.
Therefore,
estimated
cancer
dietary
risk
is
below
HED's
level
of
concern.

I.
Introduction
Amitraz
Dietary
Exposure
Assessment
DP
Number:
D300300
PC
Code:
106201
Page:
4
of
20
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).

The
most
recent
dietary
risk
assessment
for
amitraz
was
conducted
by
Jennifer
Wintersteen
(
11/
25/
94,
no
DP
Barcode).

II.
Residue
Information
Amitraz
[
N'­(
2,4­
dimethylphenyl)­
N­[[(
2,4­
dimethylphenyl)
imino]
methyl]­
N­
methyl
methanimidamide]
is
an
insecticide/
acaricide
with
registered
food/
feed
uses
in
the
U.
S.
on
cotton
and
undelinted
seeds
(
1
ppm),
pears
(
3
ppm),
honey
(
1
ppm),
honeycomb
(
6
ppm),
dried
hop
cones
(
60
ppm),
beef
and
dairy
cattle,
and
hogs
[
40
CFR
§
180.287].
Amitraz
is
currently
registered
for
use
on
cotton
to
control
various
insects
(
bollworm
larvae
and
eggs,
beet
armyworm,
whitefly,
aphids,
and
spider
mites)
as
well
as
on
pears
for
the
control
of
pear
psylla
and
grape
mealybug.
Amitraz
can
be
applied
by
airblast
and
concentrate
spray
(
pears)
with
up
to
3.0
lb
a.
i./
acre
applied
during
dormancy
and
throughout
the
growing
season
excluding
prebloom
applications.
It
can
also
be
applied
via
ground
boom
or
aircraft
(
cotton)
with
up
to
1.0
lb
a.
i./
acre
during
the
growing
season
with
a
maximum
of
eight
applications
per
year.
Currently,
the
1.5
lb/
gal
soluble
concentrate
(
SC),
50%
wettable
powder
(
WP),
and
12.5%
emulsifiable
concentrate
(
EC)
formulations
are
registered
for
use
on
food/
feed
sites.
The
SC
formulation
is
registered
for
use
on
cotton,
and
the
WP
formulation
is
registered
for
use
on
pears.
The
EC
formulation
is
registered
for
use
on
cattle
and
swine
as
dermal
treatments.

In
a
recent
letter
to
the
Agency,
BCS
has
decided
to
voluntarily
withdraw
the
registrations
of
Ovaysn
Insecticide/
Miticide
(
EPA
Reg.
No.
264­
625)
and
Mitac
W
Insecticide
(
EPA
Reg.
No.
264­
636)
on
apples,
beeswax,
honey
and
pears.
The
registrant
has
requested
to
maintain
the
registration
of
technical
amitraz,
for
import
tolerances
on
hops
and
cottonseed
(
Amitraz
Use
Closure
Memo,
10/
22/
03).

Currently,
there
are
registered
direct
animal
treatments
of
amitraz
to
beef
and
dairy
cattle
and
hogs.
The
only
registered
amitraz
use
with
associated
livestock
feed
items
is
cotton,
which
the
Amitraz
Dietary
Exposure
Assessment
DP
Number:
D300300
PC
Code:
106201
Page:
5
of
20
registrants
do
not
intend
to
support.
The
9/
93
RED
Chapter
indicated
that
it
is
highly
unlikely
that
beef
cattle
would
be
exposed
to
amitraz
via
consumption
of
treated
commodities;
dairy
cattle
in
milksheds
in
which
cottonseed
is
readily
available
may
be
exposed
to
amitraz
both
dermally
and
in
the
diet.
Residues
of
amitraz
in
meat,
fat,
and
meat
byproducts
are
likely
to
result
from
dermal
application
only,
while
amitraz
residues
in
milk
may
be
the
result
of
dermal
application
and/
or
consumption
of
the
treated
feed
commodity.
Since
cottonseed
registration
in
the
U.
S.
will
not
be
supported
by
the
registrant,
residues
in
milk
will
only
result
from
dermal
application.

The
qualitative
nature
of
the
residue
in
plants
and
animals
is
adequately
understood
based
on
plant
metabolism
studies
with
apples,
beans,
lemons,
citrus,
cotton,
and
pears,
and
animal
metabolism
studies
with
cattle
and
swine
(
dermal
application)
and
cattle,
goats
and
hens
(
oral
dosing).
The
terminal
residues
of
concern
are
amitraz
and
its
metabolites
containing
the
2,4­
dimethylaniline
(
2,4­
DMA)
moiety
(
BTS­
27919
and
BTS­
27271);
these
are
the
residues
which
are
presently
included
in
the
tolerance
expression
(
MARC
review
of
7/
20/
92).

Residue
Data
Used
for
Acute,
Chronic
and/
or
Cancer
Assessment
Currently,
amitraz
may
be
applied
twice
to
beef
and
dairy
cattle
as
a
0.05%
ai
spray,
with
a
7­
day
retreatment
interval
and
no
pre­
slaughter
interval
(
PSI).
Hogs
may
be
treated
four
times
per
year
with
a
solution
containing
0.36
lb
ai/
100
gal,
or
0.05%.
A
3­
day
PSI
has
been
established.
Although
an
acceptable
dairy
cattle
feeding
study
has
been
submitted,
the
only
magnitude
of
the
residue
data
relevant
to
the
current
use
pattern
are
dermal
application
data.

Data
have
been
submitted
reflecting
total
amitraz
residues
(
residues
of
amitraz
and
its
metabolites
convertible
to
2,4­
dimethylaniline)
in
cattle
matrices
following
dermal
treatment.
Cattle
were
treated
twice
with
either
a
0.05%
or
0.15%
ai
spray
solution
with
a
7­
day
retreatment
interval
and
then
sacrificed
at
pre­
slaughter
intervals
of
1,
3,
7,
and
14
days.
The
results
of
this
study
are
presented
below.

Pre­
slaughter
Interval
(
days)
%
ai
in
Spray
Maximum
Total
Amitraz
Residues
(
ppm)
in
Cattle
Muscle
Liver
Kidney
Fat
1
0.05
(
2
applications)
0.02
0.09
0.13
0.04
3
0.01
0.08
0.08
0.07
7
<
0.01
0.04
0.02
0.02
14
<
0.01
0.02
0.01
0.01
1
0.15
(
2
applications)
0.05
0.24
0.31
0.09
3
0.02
0.15
0.21
0.09
7
<
0.01
0.07
0.07
0.04
14
<
0.01
0.03
0.01
0.02
Amitraz
Dietary
Exposure
Assessment
DP
Number:
D300300
PC
Code:
106201
Page:
6
of
20
In
addition,
in
a
study
in
which
lactating
dairy
cattle
were
treated
with
two
sprays
containing
0.025%,
0.05%,
or
0.10%
amitraz,
with
a
10­
day
retreatment
interval,
total
amitraz
residues
in
milk
were
0.003­
0.013
ppm,
0.006­
0.025
ppm,
and
0.012­
0.038
ppm,
respectively.
Residues
were
found
to
concentrate
5x
in
butterfat.
For
milk
0.015
ppm
(
0.003
ppm
x
5x)
was
used
for
dietary
risk
assessment.

Data
have
been
submitted
reflecting
total
amitraz
residues
in
hog
matrices
following
dermal
treatment.
Hogs
were
sprayed
to
runoff
with
a
solution
containing
0.1%
amitraz.
Two
applications
were
made
seven
days
apart,
and
the
hogs
were
slaughtered
one
day
following
the
second
treatment.
Maximum
combined
residues
of
amitraz
and
its
metabolites
containing
the
2,4­
dimethylaniline
moiety
were
<
0.05
ppm
in
muscle,
0.06
ppm
in
fat,
0.05
ppm
in
liver,
and
0.07
ppm
in
kidney.

A
second
hog
study
reflecting
dermal
application
was
conducted
in
which
hogs
were
treated
with
a
solution
of
2
oz
(
0.05%
amitraz)
or
4
oz
(
0.10
%
amitraz)
of
product
(
Taktic
E.
C.)
in
3
gal
of
water.
A
second
application
was
made
seven
days
after
the
first,
and
hogs
were
slaughtered
1,
3,
7,
and
14
days
following
treatment.
Maximum
combined
residues
of
amitraz
and
its
metabolites
containing
the
2,4­
dimethylaniline
moiety
were
0.006
ppm
in
muscle,
0.017
ppm
in
fat,
0.038
ppm
in
liver,
and
0.039
ppm
in
kidney
from
hogs
slaughtered
3
days
following
treatments
at
2
oz
product/
3
gal
(
approximately
1x).

A
hog
skin
processing
study
has
also
been
submitted.
The
results
of
this
study
indicated
that
residues
in
hog
skin
and
puffed
rind
exceeded
0.2
ppm
and
that
a
0.3­
ppm
tolerance
was
appropriate
for
hog
meat
byproducts.

Based
on
the
above
dermal
studies,
the
following
residue
data
were
used
for
chronic,
acute,
and
cancer
assessments:

Table
1.
Residue
Values
for
Amitraz.

Commodity
Residue
Value
Used
for
the
Chronic
and
Cancer
Assessments
(
ppm)
RDFs
Used
in
the
Acute
Assessment
Cattle,
fat
0.04
CattleFat(%
CT=
0.1)
TOTALNZ=
1
TOTALZ=
999
0.04
Cattle,
meat
byproducts
0.2
CattleMbyp(%
CT=
0.1)
TOTALNZ=
1
TOTALZ=
999
0.2
Amitraz
Dietary
Exposure
Assessment
DP
Number:
D300300
PC
Code:
106201
Page:
7
of
20
Table
1.
Residue
Values
for
Amitraz.

Commodity
Residue
Value
Used
for
the
Chronic
and
Cancer
Assessments
(
ppm)
RDFs
Used
in
the
Acute
Assessment
Cattle,
meat
0.02
CattleMeat(%
CT=
0.1)
TOTALNZ=
1
TOTALZ=
999
0.02
Hog,
fat
0.1
PigFat(%
CT=
0.1)
TOTALNZ=
1
TOTALZ=
999
0.1
Hog,
kidney
0.1
Pig
Kidney/
Liver(%
CT=
0.1)
TOTALNZ=
1
TOTALZ=
999
0.1
Hog,
liver
0.1
Pig
Kidney/
Liver(%
CT=
0.1)
TOTALNZ=
1
TOTALZ=
999
0.1
Hog,
meat
byproducts
0.3
PigMbyp(%
CT=
0.1)
TOTALNZ=
1
TOTALZ=
999
0.3
Hog,
meat
0.05
PigMeat(%
CT=
0.1)
TOTALNZ=
1
TOTALZ=
999
0.05
Milk
0.03
Milk(%
CT=
0.1)
TOTALNZ=
1
TOTALZ=
999
0.03
Milk,
fat
0.2
MilkFat(%
CT=
0.1)
TOTALNZ=
1
TOTALZ=
999
0.2
Amitraz
Dietary
Exposure
Assessment
DP
Number:
D300300
PC
Code:
106201
Page:
8
of
20
For
all
commodities,
a
percent
crop
treated
value
of
0.1%
was
used
(
communication
between
BEAD
and
HED,
2/
23/
04).

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
(
OPP)
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
pestices.
LifelineTM
is
one
such
model
and
is
the
sofware
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.

IIIa.
DEEM­
FCID
 
Program
and
Consumption
Information
Amitraz
acute
and
chronic
dietary
exposure
assessments
were
conducted
using
the
Dietary
Exposure
Evaluation
Model
software
with
the
Food
Commodity
Intake
Database
(
DEEMFCID
 
,
Version
1.30),
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.
For
an
acute
exposure
assessment
data
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.
Amitraz
Dietary
Exposure
Assessment
DP
Number:
D300300
PC
Code:
106201
Page:
9
of
20
For
acute
exposure
assessments,
individual
one­
day
food
consumption
data
are
used
on
an
individual­
by­
individual
basis.
The
reported
consumption
amounts
of
each
food
item
can
be
multiplied
by
a
residue
point
estimate
and
summed
to
obtain
a
total
daily
pesticide
exposure
for
a
deterministic
exposure
assessment,
or
"
matched"
in
multiple
random
pairings
with
residue
values
and
then
summed
in
a
probabilistic
assessment.
The
resulting
distribution
of
exposures
is
expressed
as
a
percentage
of
the
aPAD
on
both
a
user
(
i.
e.,
those
who
reported
eating
relevant
commodities/
food
forms)
and
a
per­
capita
(
i.
e.,
those
who
reported
eating
the
relevant
commodities
as
well
as
those
who
did
not)
basis.
In
accordance
with
HED
policy,
per
capita
exposure
and
risk
are
reported
for
all
tiers
of
analysis.
However,
for
tiers
1
and
2,
significant
differences
in
user
vs.
per
capita
exposure
and
risk
are
identified
and
noted
in
the
risk
assessment.

III
b.
Lifeline
 
Program
and
Consumption
Information
Amitraz
acute,
chronic
and
cancer
dietary
exposure
estimates
were
also
conducted
using
the
Lifeline
 
model
(
Version
2.0).
The
Lifeline
 
assessments
were
also
conducted
using
the
same
consumption
data
as
the
DEEM­
FCID
 
(
CSFII,
1994­
1996
and
1998
consumption
data
with
FCID).
Lifeline
 
uses
the
recipe
file
to
relate
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.

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.
The
Lifeline
 
model
estimates
acute
exposure
based
on
the
acute
1­
day
dietary
dose
drawn
randomly
from
an
age­
specific
seasonal
exposure
profile
of
1000
individuals.
The
Lifeline
 
chronic
dietary
exposure
estimate
is
based
on
an
average
daily
exposure
from
a
profile
of
1000
individuals
over
a
one
year
period.
Further
information
regarding
the
Lifeline
 
model
can
be
found
at
the
following
web
site:
www.
theLifeline
 
group.
org.

IV.
Toxicological
Information
On
February
3,
2004,
the
Health
Effects
Division
(
HED)
Hazard
Identification
Assessment
Review
Committee
(
HIARC)
reviewed
the
recommendations
of
the
toxicology
reviewer
for
Amitraz
with
regard
to
the
acute
and
chronic
Reference
Doses
(
RfDs)
and
the
toxicological
endpoint
selection
for
use
as
appropriate
in
occupational/
residential
exposure
risk
assessments.
Amitraz
Dietary
Exposure
Assessment
DP
Number:
D300300
PC
Code:
106201
Page:
10
of
20
The
potential
for
increased
susceptibility
of
infants
and
children
from
exposure
to
Amitraz
was
also
evaluated
as
required
by
the
Food
Quality
Protection
Act
(
FQPA)
of
1996
in
accordance
with
the
2002
OPP
10X
guidance
document.
The
findings
of
this
meeting,
as
relates
to
dietary
exposure,
are
presented
in
Table
2,
below.

Table
2.
Summary
of
Toxicological
Dose
and
Endpoints
for
Amitraz
Exposure
Scenario
Dose
Used
in
Risk
Assessment,
UF
Special
FQPA
SF*
and
Level
of
Concern
for
Risk
Assessment
Study
and
Toxicological
Effects
Acute
Dietary
(
General
population
including
infants
and
children)
NOAEL
=
0.25
mg/
kg/
day
UF
=
1000
Acute
RfD
=
0.00025
mg/
kg/
day
FQPA
SF
=
1
aPAD
=
acute
RfD
FQPA
SF
=
0.00025
mg/
kg/
day
Chronic
oral
study
in
the
dog
(
capsule)
LOAEL
=
1.0
mg/
kg/
day
based
on
CNS
depression
during
the
first
two
days
of
dosing.

Chronic
Dietary
(
All
populations)
NOAEL=
0.25
mg/
kg/
day
UF
=
1000
Chronic
RfD
=
0.00025
mg/
kg/
day
FQPA
SF
=
1
cPAD
=
chronic
RfD
FQPA
SF
=
0.00025
mg/
kg/
day
Chronic
oral
study
in
the
dog
(
capsule)
LOAEL
=
1.0
mg/
kg/
day
based
on
CNS
depression
during
the
first
two
days
of
dosing.

Cancer
(
oral,
dermal,
inhalation)
Q1*
=
2.83
x
10­
2
Group:
C
Combined
hepatocellular
adenomas
and
carcinomas
in
female
mice.

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.

V.
Results/
Discussion
As
stated
above,
for
acute
and
chronic
assessments,
HED
is
concerned
when
dietary
risk
exceeds
100%
of
the
PAD.
The
Lifeline
 
and
DEEM­
FCID
 
analyses
estimate
the
dietary
exposure
of
the
U.
S.
population
and
various
population
subgroups.
The
results
reported
in
Table
X
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.
Cancer
risk
is
determined
for
the
general
U.
S.
population
only.

Results
of
Acute
Dietary
Exposure
Analysis
Amitraz
Dietary
Exposure
Assessment
DP
Number:
D300300
PC
Code:
106201
Page:
11
of
20
The
results
of
the
acute
dietary
exposure
analysis
at
the
95th,
99th,
and
99.9th
percentiles
of
exposure
are
reported
in
Table
3.

Table
3.
Results
of
Acute
Dietary
Exposure
Analysis
Using
both
DEEM­
FCID
 
and
Lifeline
 
Softwares
(
DEEM­
FCID
 
results
on
the
line
below
for
purposes
of
comparison)

Population
Subgroup
aPAD
(
mg/
kg/
day)
95th
Percentile
99th
Percentile
99.9th
Percentile
Exposure
(
mg/
kg/
day)
%
aPAD
Exposure
(
mg/
kg/
day)
%
aPAD
Exposure
(
mg/
kg/
day)
%
aPAD
U.
S.
Population
0.00025
0.000001
<
1
0.000008
3
0.000098
39
0.000001
<
1
0.000020
<
1
0.000063
25
All
Infants
(<
1year
old)
0.00025
0.000001
<
1
0.000008
3
0.000162
65
0.000001
<
1
0.000001
<
1
0.000090
36
Children
1­
2
years
old
0.00025
0.000001
<
1
0.000050
20
0.000465
186
0.000001
<
1
0.000007
3
0.000349
140
Children
3­
5
years
old
0.00025
0.000001
<
1
0.000042
17
0.000425
170
0.000001
<
1
0.000006
2
0.000234
94
Children
6­
12
years
old
0.00025
0.000001
<
1
0.000017
7
0.000168
67
0.000001
<
1
0.000004
2
0.000137
55
Youth
13­
19
years
old
0.00025
0.000001
<
1
0.000008
3
0.0000100
40
0.000001
<
1
0.000001
<
1
0.000060
24
Adults
20­
49
years
old
0.00025
0.000001
<
1
0.000006
2
0.000062
25
0.000001
<
1
0.000001
<
1
0.000044
18
Adults
50+
years
old
0.00025
0.000001
<
1
0.000006
2
0.000069
28
0.000001
<
1
0.000001
<
1
0.000040
16
Females
13­
49
years
old
0.00025
0.000001
<
1
0.000007
3
0.000072
29
0.000001
<
1
0.000001
<
1
0.000043
17
Acute
dietary
risks,
using
Lifeline
 
Model,
are
above
HED's
level
of
concern
for
children
1­
2
yrs
(
186%
of
aPAD,
0.000465
mg/
kg/
day)
and
children
3­
5
years
old
(
170%
of
aPAD,
0.000425
mg/
kg/
day)
at
the
99.9th
percentile
of
exposure.

Acute
dietary
risks,
using
DEEM­
FCID
 
,
are
above
HED's
level
of
concern
for
children
1­
2
yrs
(
140%
of
aPAD,
0.000349
mg/
kg/
day)
at
the
99.9th
percentile
of
exposure.
Amitraz
Dietary
Exposure
Assessment
DP
Number:
D300300
PC
Code:
106201
Page:
12
of
20
Results
of
Chronic
and
Cancer
Dietary
Exposure
Analysis
The
results
of
the
chronic
dietary
exposure
analysis
are
reported
in
the
summary
table
below.
Results
of
the
Lifeline
 
analysis
are
fully
consistent
with
DEEM­
FCID
 
results.
Estimated
chronic
dietary
risk
is
below
HED's
level
of
concern
for
all
populations
(<
1%
of
cPAD).

The
estimated
exposure
of
the
general
U.
S.
population
to
amitraz
is
<
0.000001
mg/
kg/
day
for
both
dietary
risk
assessment
models.
Applying
the
Q
1*
of
2.83
x
10­
2
(
mg/
kg/
day)­
1
to
the
exposure
value
results
in
a
cancer
risk
estimate
of
2.8
x
10­
8.
Therefore,
estimated
cancer
dietary
risk
is
below
HED's
level
of
concern.
Results
are
shown
in
the
Table
below.

Table
4.
Summary
of
Acute,
Chronic,
and
Cancer
Dietary
Exposure
and
Risk
Estimates
for
Amitraz.

Population
Subgroup
PAD,
mg/
kg/
day
DEEM­
FCID
 
Lifeline
 
Exposure,
mg/
kg/
day
%
PAD
Exposure,
mg/
kg/
day
%
PAD
Acute
Dietary
Estimates
(
99.9th
Percentile
of
Exposure)

U.
S.
Population
0.00025
0.000063
25
0.000098
39
All
infants
(<
1
yr)
0.00025
0.000090
36
0.000162
65
Children
1­
2
yrs
0.00025
0.000349
140
0.000465
186
Children
3­
5
yrs
0.00025
0.000234
94
0.000425
170
Children
6­
12
yrs
0.00025
0.000137
55
0.000168
67
Youth
13­
19
yrs
0.00025
0.000060
24
0.00010
40
Adults
20­
49
yrs
0.00025
0.000044
18
0.000063
25
Adults
50+
yrs
0.00025
0.000040
16
0.000069
28
Females
13­
49
yrs
0.00025
0.000043
17
0.000073
29
Chronic
Dietary
Estimates
U.
S.
Population
0.00025
0.000001
<
1
0.000001
<
1
All
infants
(<
1
yr)
0.00025
0.000001
<
1
0.000001
<
1
Children
1­
2
yrs
0.00025
0.000001
<
1
0.000001
<
1
Children
3­
5
yrs
0.00025
0.000001
<
1
0.000001
<
1
Children
6­
12
yrs
0.00025
0.000001
<
1
0.000001
<
1
Youth
13­
19
yrs
0.00025
0.000001
<
1
0.000001
<
1
Adults
20­
49
yrs
0.00025
0.000001
<
1
0.000001
<
1
Adults
50+
yrs
0.00025
0.000001
<
1
0.000001
<
1
Females
13­
49
yrs
0.00025
0.000001
<
1
0.000001
<
1
Cancer
Dietary
Estimate
U.
S.
Population
0.028
<
0.000001
2.8
x
10­
8
<
0.000001
2.8
x
10­
8
Amitraz
Dietary
Exposure
Assessment
DP
Number:
D300300
PC
Code:
106201
Page:
13
of
20
VI.
Characterization
of
Inputs/
Outputs
As
noted
in
this
risk
assessment,
DEEM
 
and
Lifeline
 
provided
different
predicted
exposure
at
the
99.9th
percentiles
for
the
1
to
2
and
3
to
5
year
old
subpopulations
(
both
exceeding
the
aPAD).
The
assessment
accounts
for
exposure
from
the
three
RACs:
meat,
pork
and
milk.
Milk
is
the
primary
RAC
that
drives
exposure
at
the
99.9th
percentile
due
to
the
relatively
high
residues.
Lifeline
 
had
relatively
higher
predictions
for
both
the
1
to
2
year
old
(
186%
vs
140%
aPAD),
and
3
to
5
year
old
subpopulations
(
170%
vs
94%
aPAD).
The
different
model
predictions
can
be
attributed
to
two
reasons:
(
1)
a
limitation
regarding
the
Lifeline
 
software,
and
(
2)
modeling
differences
between
DEEM
 
and
Lifeline
 
.
A
complete
explanation
of
how
these
factors
affect
the
model
predictions
will
be
presented
in
a
subsequent
memo.
The
apparent
limitation
in
Lifeline
 
software
is
the
result
of
several
concurrent
factors:
(
i)
milk
is
treated
as
a
food
comprised
of
three
RACS
(
water,
non­
fat
solids,
fat),
(
ii)
the
percent
crop
treated
is
relatively
low
(
0.1%),
and
(
iii)
the
Lifeline
 
.
Food
Residue
Translator
(
FRT)
approximates
food
(
milk)
residue
percentiles
based
on
a
fixed
number
of
simulations.
The
difference
in
modeling
design
(
frequency
of
using
food
diaries
and
weights
applied)
also
contribute
towards
the
Lifeline
 
model
providing
higher
exposure
estimates
than
DEEM
 
.
This
latter
effect
is
independent
of
the
first
effect,
however,
it
is
also
dependent
upon
the
percent
crop
treated
value
used
for
milk.

Given
the
relatively
high
anticipated
residues
for
milk
(
0.03
ppm),
a
moderate
amount
of
milk
consumption
may
provide
exposure
exceeding
the
aPAD.
For
example,
a
20
kg
toddler
(
typical
5
year
old),
consuming
8
ounces
of
milk
(
226
grams
=
8
x
28.3
grams/
oz),
or
equivalently,
11.3
grams/
kg
bwt/
day
(~
226/
20),
would
have
dietary
exposure
of
approximately
0.0003
mg
ai/
kg
bwt/
day
(=
0.03
ppm
x
11.3
gm/
kg
bwt/
day
x
(
1/
1000)),
or
135%
of
the
aPAD
(=
0.00025).
The
average
milk
consumption
for
1­
4
year
olds
is
approximately
337
gm/
day,
with
75%
of
toddlers
(
1to5
year
olds)
consuming
11
grams/
kg
bwt/
day
or
more
of
dairy
products.
Even
though
the
other
two
commodities
(
beef,
pork)
provide
relatively
low
exposure,
milk
continues
to
provide
exposure
at
the
99.9th
percentile
even
with
the
low
percent
crop
treated
due
to
the
application
of
residues
to
the
three
milk
components
(
water,
fat,
non­
fat
solids),
and
the
relatively
high
percent
of
toddlers
that
consume
milk.

VII.
Conclusions
Refined
probabilistic
acute,
chronic,
and
cancer
dietary
risk
assessments
were
conducted
using
DEEM­
FCID
 
(
Version
1.30)
and
the
Lifeline
 
Model
(
Version
2.0)
which
uses
food
consumption
data
from
the
United
States
Department
of
Agriculture's
(
USDA's).
Continuing
Surveys
of
Food
Intakes
by
Individuals
(
CSFII)
from
1994­
1996
and
1998.
Chronic
and
acute
exposure
estimates
were
based
on
data
from
dermal
metabolism
studies
provided
by
the
registrant
and
percent
crop
treated
provided
by
BEAD.
Conservative
assumptions
were
made
in
the
calculation
of
anticipated
residues
used
in
the
dietary
assessment.
Acute
dietary
risks,
using
Lifeline
 
Model,
are
above
HED's
level
of
concern
for
children
1­
2
yrs
(
186%
of
aPAD,
0.000465
mg/
kg/
day)
and
children
3­
5
years
old
(
170%
of
aPAD,
0.000425
mg/
kg/
day)
at
the
99.9th
percentile
of
exposure.
Acute
dietary
risks,
using
DEEM­
FCID
 
,
are
above
HED's
level
Amitraz
Dietary
Exposure
Assessment
DP
Number:
D300300
PC
Code:
106201
Page:
14
of
20
of
concern
for
children
1­
2
yrs
(
140%
of
aPAD,
0.000349
mg/
kg/
day)
at
the
99.9th
percentile
of
exposure.
Results
of
the
Lifeline
 
analysis
are
fully
consistent
with
DEEM­
FCID
 
results
for
the
chronic
dietary
risk
estimates.
Estimated
chronic
dietary
risk
is
below
HED's
level
of
concern
for
all
populations
(<
1%
of
cPAD).
The
estimated
exposure
of
the
general
U.
S.
population
to
amitraz
is
<
0.000001
mg/
kg/
day
for
both
dietary
risk
assessment
models.
Applying
the
Q
1*
of
2.83
x
10­
2
(
mg/
kg/
day)­
1
to
the
exposure
value
results
in
a
cancer
risk
estimate
of
2.8
x
10­
8.
Therefore,
estimated
cancer
dietary
risk
is
below
HED's
level
of
concern.

VIII.
List
of
Attachments
°
Acute
Food
Residue
Input
file.
°
Acute
Results
file.
°
Chronic/
Cancer
Food
Residue
Input
file.
°
Chronic
Results
file.
°
Cancer
Results
File.

U.
S.
Environmental
Protection
Agency
Ver.
2.02
DEEM­
FCID
Acute
analysis
for
AMITRAZ
Residue
file
name:
C:\
My
DEEM\
Amitraz\
Amitraz.
R98
Analysis
Date
04­
19­
2004
Residue
file
dated:
03­
02­
2004/
14:
23:
39/
8
Reference
dose
(
aRfD)
=
0.00025
mg/
kg
bw/
day
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
­­
RDL
indices
and
parameters
for
Monte
Carlo
Analysis:
Index
Dist
Parameter
#
1
Param
#
2
Param
#
3
Comment
#
Code
­­­­­
­­­­
­­­­­­­­­­­­
­­­­­­­­­­­
­­­­­­­­­­­
­­­­­­­­­­
1
6
C:\
My
DEEM\
Amitraz\
CattleFat.
rdf
2
6
C:\
My
DEEM\
Amitraz\
Cattlembyp.
rdf
3
6
C:\
My
DEEM\
Amitraz\
Cattlemeat.
rdf
4
6
C:\
My
DEEM\
Amitraz\
Milk.
rdf
5
6
C:\
My
DEEM\
Amitraz\
Milkfat.
rdf
6
6
C:\
My
DEEM\
Amitraz\
Pigfat.
rdf
7
6
C:\
My
DEEM\
Amitraz\
PigkidLiv.
rdf
8
6
C:\
My
DEEM\
Amitraz\
PigMbyp.
rdf
9
6
C:\
My
DEEM\
Amitraz\
PigMeat.
rdf
Amitraz
Dietary
Exposure
Assessment
DP
Number:
D300300
PC
Code:
106201
Page:
15
of
20
EPA
Crop
Food
Name
Def
Res
Adj.
Factors
RDL
Comment
Code
Grp
(
ppm)
#
1
#
2
Pntr
­­­­­­­­
­­­­
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
­­­­­­­­­­
­­­­­­
­­­­­­
­­­
­­­­­­­
21000440
M
Beef,
meat
1.000000
1.000
1.000
3
21000441
M
Beef,
meat­
babyfood
1.000000
1.000
1.000
3
21000450
M
Beef,
meat,
dried
1.000000
1.000
1.000
3
21000460
M
Beef,
meat
byproducts
1.000000
1.000
1.000
2
21000461
M
Beef,
meat
byproducts­
babyfood
1.000000
1.000
1.000
2
21000470
M
Beef,
fat
1.000000
1.000
1.000
1
21000471
M
Beef,
fat­
babyfood
1.000000
1.000
1.000
1
21000480
M
Beef,
kidney
1.000000
1.000
1.000
2
21000490
M
Beef,
liver
1.000000
1.000
1.000
2
21000491
M
Beef,
liver­
babyfood
1.000000
1.000
1.000
2
27002220
D
Milk,
fat
1.000000
1.000
1.000
5
27002221
D
Milk,
fat
­
baby
food/
infant
for
1.000000
1.000
1.000
5
27012230
D
Milk,
nonfat
solids
1.000000
1.000
1.000
4
27012231
D
Milk,
nonfat
solids­
baby
food/
in
1.000000
1.000
1.000
4
27022240
D
Milk,
water
1.000000
1.000
1.000
4
27022241
D
Milk,
water­
babyfood/
infant
form
1.000000
1.000
1.000
4
27032251
D
Milk,
sugar
(
lactose)­
baby
food/
1.000000
1.000
1.000
4
25002900
M
Pork,
meat
1.000000
1.000
1.000
9
25002901
M
Pork,
meat­
babyfood
1.000000
1.000
1.000
9
25002910
M
Pork,
skin
1.000000
1.000
1.000
6
25002920
M
Pork,
meat
byproducts
1.000000
1.000
1.000
8
25002921
M
Pork,
meat
byproducts­
babyfood
1.000000
1.000
1.000
8
25002930
M
Pork,
fat
1.000000
1.000
1.000
6
25002931
M
Pork,
fat­
babyfood
1.000000
1.000
1.000
6
25002940
M
Pork,
kidney
1.000000
1.000
1.000
7
25002950
M
Pork,
liver
1.000000
1.000
1.000
7
U.
S.
Environmental
Protection
Agency
Ver.
1.33
DEEM­
FCID
ACUTE
Analysis
for
AMITRAZ
(
1994­
98
data)
Residue
file:
Amitraz.
R98
Adjustment
factor
#
2
used.
Analysis
Date:
03­
09­
2004/
11:
47:
28
Residue
file
dated:
03­
02­
2004/
14:
23:
39/
8
Daily
totals
for
food
and
foodform
consumption
used.
MC
iterations
=
2000
MC
list
in
residue
file
MC
seed
=
10
Run
Comment:
"
3/
9/
04"
===============================================================================

Summary
calculations
(
per
capita):

95th
Percentile
99th
Percentile
99.9th
Percentile
Exposure
%
aRfD
Exposure
%
aRfD
Exposure
%
aRfD
­­­­­­­­­­
­­­­­­­­
­­­­­­­­­­
­­­­­­­­
­­­­­­­­­­
­­­­­­­­
U.
S.
Population:
0.000000
0.00
0.000002
0.61
0.000064
25.58
Hispanics:
0.000000
0.00
0.000001
0.46
0.000079
31.50
All
infants:
0.000000
0.00
0.000000
0.00
0.000090
36.01
Nursing
infants
(<
1
yr
old):
0.000000
0.00
0.000000
0.00
0.000012
4.78
Non­
nursing
infants
(<
1
yr
old):
0.000000
0.00
0.000000
0.00
0.000132
52.72
Children
1­
6
yrs:
0.000000
0.00
0.000006
2.53
0.000265
105.82
Amitraz
Dietary
Exposure
Assessment
DP
Number:
D300300
PC
Code:
106201
Page:
16
of
20
Children
7­
12
yrs:
0.000000
0.00
0.000004
1.43
0.000130
52.18
Females
13+
(
nursing):
0.000000
0.00
0.000001
0.45
0.000063
25.21
Females
13­
50
yrs:
0.000000
0.00
0.000001
0.30
0.000042
16.86
Males
13­
19
yrs:
0.000000
0.00
0.000002
0.80
0.000073
29.05
Males
20+
yrs:
0.000000
0.00
0.000001
0.46
0.000047
18.63
Seniors
55+:
0.000000
0.00
0.000001
0.36
0.000041
16.28
Children
1­
2
yrs:
0.000000
0.00
0.000007
2.63
0.000354
141.74
Amitraz
Dietary
Exposure
Assessment
DP
Number:
D300300
PC
Code:
106201
Page:
17
of
20
U.
S.
Environmental
Protection
Agency
Ver.
1.33
DEEM­
FCID
ACUTE
Analysis
for
AMITRAZ
(
1994­
98
data)
Residue
file:
Amitraz.
R98
Adjustment
factor
#
2
used.
Analysis
Date:
03­
09­
2004/
11:
47:
28
Residue
file
dated:
03­
02­
2004/
14:
23:
39/
8
Daily
totals
for
food
and
foodform
consumption
used.
MC
iterations
=
2000
MC
list
in
residue
file
MC
seed
=
10
Run
Comment:
"
3/
9/
04"
===============================================================================

Summary
calculations:

95th
Percentile
99th
Percentile
99.9th
Percentile
Exposure
%
aRfD
Exposure
%
aRfD
Exposure
%
aRfD
­­­­­­­­­­
­­­­­­­­
­­­­­­­­­­
­­­­­­­­
­­­­­­­­­­
­­­­­­­­
Children
3­
5
yrs:
0.000000
0.00
0.000006
2.43
0.000236
94.51
Children
6­
12
yrs:
0.000000
0.00
0.000004
1.54
0.000140
56.01
Youth
13­
19
yrs:
0.000000
0.00
0.000002
0.62
0.000063
25.08
Adults
20­
49
yrs:
0.000000
0.00
0.000001
0.37
0.000045
17.80
Adults
50+
yrs:
0.000000
0.00
0.000001
0.35
0.000040
16.16
Females
13­
49
yrs:
0.000000
0.00
0.000001
0.30
0.000042
16.93
"
Amitraz"
Chronic
Input
File
0.00025
FCIDMC1,
0.00025
NOEL,
0
0
0.0283
03­
09­
2004/
11:
00:
09
60
"
21000440","
M",
0.02
1
0.001
0
"
Beef,
meat",
""
61
"
21000441","
M",
0.02
1
0.001
0
"
Beef,
meat­
babyfood",
""
62
"
21000450","
M",
0.02
1
0.001
0
"
Beef,
meat,
dried",
""
63
"
21000460","
M",
0.2
1
0.001
0
"
Beef,
meat
byproducts",
""
64
"
21000461","
M",
0.2
1
0.001
0
"
Beef,
meat
byproducts­
babyfood",
""
65
"
21000470","
M",
0.04
1
0.001
0
"
Beef,
fat",
""
66
"
21000471","
M",
0.04
1
0.001
0
"
Beef,
fat­
babyfood",
""
67
"
21000480","
M",
0.2
1
0.001
0
"
Beef,
kidney",
""
68
"
21000490","
M",
0.2
1
0.001
0
"
Beef,
liver",
""
69
"
21000491","
M",
0.2
1
0.001
0
"
Beef,
liver­
babyfood",
""
287
"
27002220","
D",
0.2
1
0.001
0
"
Milk,
fat",
""
288
"
27002221","
D",
0.2
1
0.001
0
"
Milk,
fat
­
baby
food/
infant
formula",
""
289
"
27012230","
D",
0.03
1
0.001
0
"
Milk,
nonfat
solids",
""
290
"
27012231","
D",
0.03
1
0.001
0
"
Milk,
nonfat
solids­
baby
food/
infant
fo",
""
291
"
27022240","
D",
0.03
1
0.001
0
"
Milk,
water",
""
292
"
27022241","
D",
0.03
1
0.001
0
"
Milk,
water­
babyfood/
infant
formula",
""
293
"
27032251","
D",
0.03
1
0.001
0
"
Milk,
sugar
(
lactose)­
baby
food/
infant",
""
386
"
25002900","
M",
0.05
1
0.001
0
"
Pork,
meat",
""
387
"
25002901","
M",
0.05
1
0.001
0
"
Pork,
meat­
babyfood",
""
388
"
25002910","
M",
0.1
1
0.001
0
"
Pork,
skin",
""
389
"
25002920","
M",
0.3
1
0.001
0
"
Pork,
meat
byproducts",
""
390
"
25002921","
M",
0.3
1
0.001
0
"
Pork,
meat
byproducts­
babyfood",
""
391
"
25002930","
M",
0.1
1
0.001
0
"
Pork,
fat",
""
392
"
25002931","
M",
0.1
1
0.001
0
"
Pork,
fat­
babyfood",
""
393
"
25002940","
M",
0.1
1
0.001
0
"
Pork,
kidney",
""
394
"
25002950","
M",
0.1
1
0.001
0
"
Pork,
liver",
""
Amitraz
Dietary
Exposure
Assessment
DP
Number:
D300300
PC
Code:
106201
Page:
18
of
20
U.
S.
Environmental
Protection
Agency
Ver.
1.30
DEEM­
FCID
Chronic
analysis
for
AMITRAZ
(
1994­
98
data)
Residue
file
name:
C:\
My
DEEM\
Amitraz\
Amitraz2.
R98
Adjustment
factor
#
2
used.
Analysis
Date
03­
09­
2004/
10:
57:
42
Residue
file
dated:
03­
09­
2004/
10:
56:
37/
8
Reference
dose
(
RfD,
Chronic)
=
.00025
mg/
kg
bw/
day
COMMENT
1:
Run
with
0.1%
CT
===============================================================================
Total
exposure
by
population
subgroup
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­

Total
Exposure
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
Population
mg/
kg
Percent
of
Subgroup
body
wt/
day
Rfd
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
­­­­­­­­­­­­­
­­­­­­­­­­­­­­­
U.
S.
Population
(
total)
0.000000
0.1%

U.
S.
Population
(
spring
season)
0.000000
0.1%
U.
S.
Population
(
summer
season)
0.000000
0.1%
U.
S.
Population
(
autumn
season)
0.000000
0.1%
U.
S.
Population
(
winter
season)
0.000000
0.1%

Northeast
region
0.000000
0.1%
Midwest
region
0.000000
0.1%
Southern
region
0.000000
0.1%
Western
region
0.000000
0.1%

Hispanics
0.000000
0.2%
Non­
hispanic
whites
0.000000
0.1%
Non­
hispanic
blacks
0.000000
0.1%
Non­
hisp/
non­
white/
non­
black
0.000000
0.1%

All
infants
(<
1
year)
0.000000
0.2%
Nursing
infants
0.000000
0.0%
Non­
nursing
infants
0.000001
0.2%
Children
1­
6
yrs
0.000001
0.4%
Children
7­
12
yrs
0.000001
0.2%

Females
13­
19
(
not
preg
or
nursing)
0.000000
0.1%
Females
20+
(
not
preg
or
nursing)
0.000000
0.1%
Females
13­
50
yrs
0.000000
0.1%
Females
13+
(
preg/
not
nursing)
0.000000
0.1%
Females
13+
(
nursing)
0.000000
0.1%

Males
13­
19
yrs
0.000000
0.1%
Males
20+
yrs
0.000000
0.1%
Seniors
55+
0.000000
0.1%

Children
1­
2
yrs
0.000001
0.6%
Children
3­
5
yrs
0.000001
0.4%
Children
6­
12
yrs
0.000001
0.2%
Youth
13­
19
yrs
0.000000
0.1%
Adults
20­
49
yrs
0.000000
0.1%
Adults
50+
yrs
0.000000
0.1%
Females
13­
49
yrs
0.000000
0.1%

­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­

U.
S.
Environmental
Protection
Agency
Ver.
1.30
DEEM­
FCID
Chronic
analysis
for
AMITRAZ
(
1994­
98
data)
Amitraz
Dietary
Exposure
Assessment
DP
Number:
D300300
PC
Code:
106201
Page:
19
of
20
Residue
file
name:
C:\
My
DEEM\
Amitraz\
Amitraz2.
R98
Adjustment
factor
#
2
used.
Analysis
Date
03­
09­
2004/
10:
58:
18
Residue
file
dated:
03­
09­
2004/
10:
56:
37/
8
Q*
=
0.0283
COMMENT
1:
Run
with
0.1%
CT
==============================================================================
=
Total
exposure
by
population
subgroup
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
­

Total
Exposure
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
Population
mg/
kg
Lifetime
risk
Subgroup
body
wt/
day
(
Q*=
.0283)
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
­­­­­­­­­­­­­
­­­­­­­­­­­­­
U.
S.
Population
(
total)
0.000000
8.87E­
09
U.
S.
Population
(
spring
season)
0.000000
8.85E­
09
U.
S.
Population
(
summer
season)
0.000000
8.60E­
09
U.
S.
Population
(
autumn
season)
0.000000
9.20E­
09
U.
S.
Population
(
winter
season)
0.000000
8.83E­
09
Northeast
region
0.000000
9.05E­
09
Midwest
region
0.000000
9.33E­
09
Southern
region
0.000000
8.15E­
09
Western
region
0.000000
9.38E­
09
Hispanics
0.000000
1.08E­
08
Non­
hispanic
whites
0.000000
8.59E­
09
Non­
hispanic
blacks
0.000000
8.58E­
09
Non­
hisp/
non­
white/
non­
black
0.000000
9.68E­
09
All
infants
(<
1
year)
0.000000
1.27E­
08
Nursing
infants
0.000000
3.49E­
09
Non­
nursing
infants
0.000001
1.61E­
08
Children
1­
6
yrs
0.000001
3.16E­
08
Children
7­
12
yrs
0.000001
1.56E­
08
Females
13­
19
(
not
preg
or
nursing)
0.000000
6.51E­
09
Females
20+
(
not
preg
or
nursing)
0.000000
4.63E­
09
Females
13­
50
yrs
0.000000
6.08E­
09
Females
13+
(
preg/
not
nursing)
0.000000
7.74E­
09
Females
13+
(
nursing)
0.000000
7.50E­
09
Males
13­
19
yrs
0.000000
9.05E­
09
Males
20+
yrs
0.000000
5.46E­
09
Seniors
55+
0.000000
4.83E­
09
Children
1­
2
yrs
0.000001
4.12E­
08
Children
3­
5
yrs
0.000001
2.79E­
08
Children
6­
12
yrs
0.000001
1.68E­
08
Youth
13­
19
yrs
0.000000
7.83E­
09
Adults
20­
49
yrs
0.000000
5.24E­
09
Amitraz
Dietary
Exposure
Assessment
DP
Number:
D300300
PC
Code:
106201
Page:
20
of
20
Adults
50+
yrs
0.000000
4.77E­
09
Females
13­
49
yrs
0.000000
5.14E­
09
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
­