Page
1
of
30
UNITED
STATES
ENVIRONMENTAL
PROTECTION
AGENCY
WASHINGTON,
D.
C.
20460
OFFICE
OF
PREVENTION,
PESTICIDES
AND
TOXIC
SUBSTANCES
MEMORANDUM
Date:
15­
JUNE­
2006
Subject:
Imidacloprid.
Section
3
Request
for
Use
on
Caneberry,
Subgroup
13A
(
PP#
3E6564);
Coffee
(
PP#
3E6561);
Sunflower
Seed
and
Oilseed
Crops
(
PP#
3E6738);
Sugar
Apple
and
Related
Crops
(
PP#
3E6760);
Tree
Nuts,
Group
14,
Including
Pistachios
(
PP#
5E6920);
Pomegranate
(
PP#
5E6921);
Banana
(
PP#
5E6922);
and
Herbs,
Subgroup
19A
(
PP#
5E6923).
Health
Effects
Division
(
HED)
Human
Health
Risk
Assessment.

PC
Code:
129099
40
CFR:
180.472
DP#
s:
322225,
322249,
322250,
322251,
322253,
322257,
322255,
322260
Decision
#
s:
352430,
352431,
352432,
355772,
355775,
355831,
355851,
352454
From:
Jennifer
R.
Tyler,
Chemist
Mark
I.
Dow,
Ph.
D.,
Biologist
Registration
Action
Branch
(
RAB1)
Health
Effects
Division
(
HED)
(
7509C)

Through:
PV
Shah,
Ph.
D.,
Branch
Senior
Scientist
RAB1/
HED
(
7509C)

Felecia
Fort,
Acting
Branch
Chief
RAB1/
HED
(
7509C)

To:
Sidney
Jackson/
Daniel
Rosenblatt,
PM
Team
05
Registration
Division
(
RD)
(
7505C)

The
HED
of
the
Office
of
Pesticide
Programs
(
OPP)
is
charged
with
estimating
the
risk
to
human
health
from
exposure
to
pesticides.
The
RD
of
OPP
has
requested
that
HED
evaluate
hazard
and
exposure
data
and
conduct
dietary,
occupational,
residential
and
aggregate
exposure
assessments,
as
needed,
to
estimate
the
risk
to
human
health
that
will
result
from
proposed
and
registered
uses
of
imidacloprid
[
1­[(
6­
chloro­
3­
pyridinyl)
methyl]­
N­
nitro­
2­
imidazolidinimine]
on
caneberry,
subgroup
13A;
coffee;
sunflower
seed
and
oilseed
crops;
sugar
apple
and
related
crops;
tree
nuts,
group
14,
including
pistachios;
pomegranate;
banana;
and
herbs,
subgroup
19A.
A
summary
of
the
findings
and
an
assessment
of
human
risk
resulting
from
the
registered
and
proposed
Page
2
of
30
tolerances
for
imidacloprid
is
provided
in
this
document.
The
risk
assessment,
the
residue
chemistry
data
review,
and
the
dietary
risk
assessment
were
provided
by
Jennifer
Tyler
(
RAB1),
the
hazard
characterization
by
David
Nixon
(
RAB1),
the
occupational/
residential
exposure
assessment
by
Mark
Dow
(
RAB1),
and
the
drinking
water
assessment
by
Ron
Parker
of
the
Environmental
Fate
and
Effects
Division
(
EFED).

INTRODUCTION
Imidacloprid
is
a
systemic
insecticide
registered
to
control
soil
insects,
sucking
insects,
chewing
insects,
and
termites.
It
is
effective
against
the
larval,
nymphal
and
adult
stages.
The
primary
mode
of
action
is
the
disruption
of
the
nervous
system
by
acting
as
an
inhibitor
at
nicotinic
acetylcholine
receptors.
Imidacloprid
blocks
the
signals
that
are
induced
by
acetylcholine
at
the
post­
synaptic
membrane,
resulting
in
nerve
function
impairment.

The
Interregional
Research
Project
No.
4
(
IR­
4)
has
submitted
the
following
petitions:

PP#
3E6543
(
Caneberry,
Subgroup
13A):
IR­
4,
on
behalf
of
the
Agricultural
Experiment
Station
of
Hawaii
(
HI),
has
submitted
a
petition
for
the
use
of
imidacloprid,
formulated
as
Admire
®
2
Flowable
(
2F,
EPA
Reg.
No.
3125­
422)
on
caneberry,
subgroup
13A.
In
addition,
IR­
4
has
requested
the
establishment
of
a
permanent
tolerance
of
0.05
ppm
for
the
combined
residues
of
imidacloprid
and
its
metabolites
containing
the
6­
chloropyridinyl
moiety,
all
expressed
as
1­[(
6­
chloro­
3­
pyridinyl)
methyl]­
N­
nitro­
2­
imidazolidinimine,
in/
on
caneberry
subgroup
13A.

PP#
3E6561
(
Coffee):
IR­
4,
on
behalf
of
the
Agricultural
Experiment
Stations
of
HI,
has
submitted
a
petition
for
the
use
of
imidacloprid,
formulated
as
Provado
®
1.6
Flowable
(
1.6F,
EPA
Reg.
No.
3125­
457)
on
coffee.
In
addition,
IR­
4
has
requested
the
establishment
of
a
permanent
tolerance
of
0.6
ppm
for
the
combined
residues
of
imidacloprid
and
its
metabolites
containing
the
6­
chloropyridinyl
moiety,
all
expressed
as
1­[(
6­
chloro­
3­
pyridinyl)
methyl]­
Nnitro
2­
imidazolidinimine,
in/
on
coffee.

PP#
3E6738
(
Sunflower
Seed
and
Oilseed
Crops):
IR­
4,
on
behalf
of
the
Agricultural
Experiment
Stations
of
Idaho
(
ID),
Georgia
(
GA),
and
North
Dakota
(
ND),
has
submitted
a
petition
for
the
use
of
imidacloprid,
formulated
as
Gaucho
®
480
Flowable
(
EPA
Reg.
No.
7501­
155)
and
Gaucho
®
600
Flowable
(
EPA
Reg.
No.
7501­
173),
on
sunflower
and
oilseed
crops.
In
addition,
IR­
4
has
requested
the
establishment
of
permanent
tolerances
of
0.05
ppm
for
the
combined
residues
of
imidacloprid
and
its
metabolites
containing
the
6­
chloropyridinyl
moiety,
all
expressed
as
1­[(
6­
chloro­
3­
pyridinyl)
methyl]­
N­
nitro­
2­
imidazolidinimine,
in/
on
rapeseed,
seed;
Indian
rapeseed,
seed;
Indian
mustard,
seed;
field
mustard,
seed;
black
mustard,
seed;
flax,
seed;
sunflower,
seed;
safflower,
seed;
crambe,
seed;
and
borage,
seed.

PP#
3E6760
(
Sugar
Apple
and
Related
Crops):
IR­
4,
on
behalf
of
the
Agricultural
Experiment
Stations
of
requesting
states,
has
submitted
a
petition
for
the
use
of
imidacloprid,
formulated
as
Provado
®
1.6F,
on
sugar
apple
and
related
crops.
In
addition,
IR­
4
has
requested
the
establishment
of
a
permanent
tolerance
of
0.2
ppm
for
the
combined
residues
of
imidacloprid
Page
3
of
30
and
its
metabolites
containing
the
6­
chloropyridinyl
moiety,
all
expressed
as
1­[(
6­
chloro­
3­
pyridinyl)
methyl]­
N­
nitro­
2­
imidazolidinimine,
in/
on
sugar
apple,
cherimoya,
atemoya,
custard
apple,
ilama,
soursop,
and
biriba.

PP#
5E6920
(
Tree
Nuts,
Group
14,
including
pistachios):
IR­
4,
on
behalf
of
the
Agricultural
Experiment
Stations
of
California
(
CA),
and
North
Carolina
(
NC),
has
submitted
a
petition
for
the
use
of
imidacloprid,
formulated
as
Admire
®
2F
and
Provado
®
1.6F,
on
tree
nuts,
group
14,
including
pistachios.
In
addition,
IR­
4
has
requested
the
establishment
of
a
permanent
tolerance
for
the
combined
residues
of
imidacloprid
and
its
metabolites
containing
the
6­
chloropyridinyl
moiety,
all
expressed
as
1­[(
6­
chloro­
3­
pyridinyl)
methyl]­
N­
nitro­
2­
imidazolidinimine,
in/
on
nut,
tree,
group
14
at
0.01
ppm;
almond,
hulls
at
2.5
ppm,
and
pistachio
at
0.01
ppm.

PP#
5E6921
(
Pomegranate):
IR­
4,
on
behalf
of
the
Agricultural
Experiment
Stations
of
CA,
has
submitted
a
petition
for
the
use
of
imidacloprid,
formulated
as
Admire
®
2F,
on
pomegranate.
In
addition,
IR­
4
has
requested
the
establishment
of
a
permanent
tolerance
of
0.7
ppm
for
the
combined
residues
of
imidacloprid
and
its
metabolites
containing
the
6­
chloropyridinyl
moiety,
all
expressed
as
1­[(
6­
chloro­
3­
pyridinyl)
methyl]­
N­
nitro­
2­
imidazolidinimine,
in/
on
pomegranate.

PP#
5E6922
(
Banana):
IR­
4,
on
behalf
of
the
Agricultural
Experiment
Stations
of
HI
and
Puerto
Rico
(
PR),
has
submitted
a
petition
for
the
use
of
imidacloprid,
formulated
as
Admire
®
2F,
Gaucho
®
550
Soluable
Concentrate
(
SC,
EPA
Reg.
No.
264­
827),
Gaucho
®
600
SC
(
EPA
Reg.
No.
264­
828),
Provado
®
1.6
1.6F,
Provado
®
75%
Solupak
(
EPA
Reg.
No.
264­
761),
and
Provado
®
70
Wettable
Granular
(
WG,
EPA
Reg.
No.
264­
823)
on
banana.
In
addition,
IR­
4
has
requested
the
establishment
of
a
permanent
tolerance
of
0.6
ppm
for
the
combined
residues
of
imidacloprid
and
its
metabolites
containing
the
6­
chloropyridinyl
moiety,
all
expressed
as
1­[(
6­
chloro­
3­
pyridinyl)
methyl]­
N­
nitro­
2­
imidazolidinimine,
in/
on
banana.

PP#
5E6923
(
Herbs,
subgroup
19A):
IR­
4,
on
behalf
of
the
Agricultural
Experiment
Stations
of
CA,
Florida
(
FL),
and
NC,
has
submitted
a
petition
for
the
use
of
imidacloprid,
formulated
as
Admire
®
2F
and
Provado
®
1.6F,
on
herbs,
subgroup
19A.
In
addition,
IR­
4
has
requested
the
establishment
of
a
permanent
tolerance
of
6
ppm
for
the
combined
residues
of
imidacloprid
and
its
metabolites
containing
the
6­
chloropyridinyl
moiety,
all
expressed
as
1­[(
6­
chloro­
3­
pyridinyl)
methyl]­
N­
nitro­
2­
imidazolidinimine,
in/
on
herb
subgroup
19A,
fresh.

NOTE:
HED
recently
completed
a
Section
3
risk
assessment
for
the
use
of
imidacloprid
on
several
commodities
(
Memo,
J.
Tyler,
et
al.
3/
4/
03;
D286101).
This
document
contains
only
those
aspects
of
the
risk
assessment
that
are
affected
by
the
addition
of
this
new
use
of
imidacloprid
on
the
aforementioned
crops.
The
following
information
from
the
last
risk
assessment
on
imidacloprid
can
be
applied
directly
to
this
action:

 
Physical/
Chemical
Properties
(
pp.
11­
12;
structures
of
all
pertinent
metabolites
mentioned
in
risk
assessment
is
in
Attachment
1).
 
Hazard
Characterization
(
pp.
12­
27;
Toxicity
Profile
is
summarized
in
Table
2,
Toxicity
Endpoint
Selection
summarized
in
Table
3).
The
hazard
characterization
and
endpoint
Page
4
of
30
table
are
presented
in
this
document
for
easy
reference.
 
Residential
Exposure
and
Risk
Assessment
(
pp.
44­
56).
 
Environmental
Fate
and
Drinking
Water
Characterization
(
pp.
43­
44).

In
this
memo,
dietary,
occupational
and
aggregate
risks
were
re­
evaluated
based
on
the
addition
of
aforementioned
crops
to
the
imidacloprid
use
patterns.

Conclusion/
Recommendations:
For
the
proposed
uses,
human
health
aggregate
risk
assessments
have
been
conducted
for
the
following
exposure
scenarios:
acute
aggregate
exposure
(
food
and
drinking
water),
short­
term
aggregate
exposure
(
food,
drinking
water,
and
residential),
and
chronic
aggregate
exposure
(
food
and
drinking
water).
Intermediate­
and
longterm
aggregate
risk
assessments
were
not
performed
because,
based
on
the
current
use
patterns,
HED
does
not
expect
exposure
durations
that
would
result
in
intermediate­
or
long­
term
exposures.
A
cancer
aggregate
risk
assessment
was
not
performed
because
imidacloprid
is
not
carcinogenic.
All
potential
exposure
pathways
were
assessed
in
the
aggregate
risk
assessment.
Dietary
(
food
and
drinking
water),
handler
and
post­
application
residential
exposures
were
considered,
as
necessary,
because
there
is
a
potential
for
individuals
to
be
exposed
concurrently
through
these
routes.
All
aggregate
exposure
and
risk
estimates
do
not
exceed
HED's
level
of
concern
for
the
scenarios
listed
above.

The
results
of
the
occupational
exposure
assessment
for
seed
treatment
indicate
the
margins
of
exposure
(
MOEs)
for
a
"
loader/
applicator"
are
59
(
using
a
single
layer
of
work
clothing
and
NO
gloves),
and
77
(
using
a
single
layer
of
work
clothing
and
gloves).
In
addition,
individuals
involved
in
"
multiple
activities,"
which
include
sweeping
the
floors
and
several
other
variable
activities
during
the
day,
have
a
MOE
of
33.
As
these
MOEs
are
less
than
100,
they
are
of
concern.
However,
the
calculated
MOEs
are
based
upon
the
most
conservative
assumptions
in
terms
of
the
high
rate
of
application
and
the
maximum
possible
amount
of
seed
treated
per
day
(
718,000
lbs).
While
it
is
possible
for
the
machinery
to
process
that
amount
of
seed,
in
the
practical
sense
HED
believes
it
is
not
probable
as
the
total
amount
of
safflower
planted
in
the
United
States
(
U.
S.)
is
much
less
than
718,000
lb
of
seed
per
day
(
see
Section
11.2
of
this
risk
assessment
for
further
explanation).
Therefore,
the
handler
MOE
for
seed
treatment
uses
are
not
of
concern.

Therefore,
provided
revised
Sections
B
and
F
with
the
modifications
as
specified
in
Section
12.0
of
this
risk
assessment
are
submitted,
the
residue
chemistry,
toxicological
and
occupational/
residential
databases
support
the
following:

 
PP#
3E6543
(
Caneberry,
Subgroup
13A):
a
conditional
registration
and
permanent
tolerance
of
0.05
ppm
for
the
combined
residues
imidacloprid
and
its
metabolites
containing
the
6­
chloropyridinyl
moiety,
all
expressed
as
1­[(
6­
chloro­
3­
pyridinyl)
methyl]­
N­
nitro­
2­
imidazolidinimine,
in/
on
caneberry,
subgroup
13A.
Conversion
from
conditional
to
unconditional
registration
is
contingent
upon
submission
of
additional
crop
field
trial
data
on
either
blackberry
or
raspberry
from
Region
1
(
1
trial),
Region
5
(
1
trial)
and
Region
10
(
1
trial).
Page
5
of
30
 
PP#
3E6561
(
Coffee):
an
unconditional
registration
and
permanent
tolerance
of
0.80
ppm
for
the
combined
residues
of
the
insecticide
imidacloprid
and
its
metabolites
containing
the
6­
chloropyridinyl
moiety,
all
expressed
as
1­[(
6­
chloro­
3­
pyridinyl)
methyl]­
N­
nitro­
2­
imidazolidinimine,
in/
on
coffee,
green
bean.
 
PP#
3E6738
(
Sunflower
Seed
and
Oilseed
Crops):
an
unconditional
registration
and
permanent
tolerances
of
0.05
ppm
for
the
combined
residues
of
the
insecticide
imidacloprid
and
its
metabolites
containing
the
6­
chloropyridinyl
moiety,
all
expressed
as
1­[(
6­
chloro­
3­
pyridinyl)
methyl]­
N­
nitro­
2­
imidazolidinimine,
in/
on
rapeseed,
seed;
Indian
rapeseed,
seed;
Indian
mustard,
seed;
field
mustard,
seed;
black
mustard,
seed;
flax,
seed;
sunflower,
seed;
safflower,
seed;
crambe,
seed;
and
borage,
seed.
 
PP#
3E6760
(
Sugar
Apple
and
Related
Crops):
an
unconditional
registration
and
permanent
tolerances
of
0.30
ppm
for
the
combined
residues
of
the
insecticide
imidacloprid
and
its
metabolites
containing
the
6­
chloropyridinyl
moiety,
all
expressed
as
1­[(
6­
chloro­
3­
pyridinyl)
methyl]­
N­
nitro­
2­
imidazolidinimine,
in/
on
sugar
apple,
cherimoya,
atemoya,
custard
apple,
ilama,
soursop,
and
biriba.
 
PP#
5E6920
(
Tree
Nuts,
Including
Pistachios):
an
unconditional
registration
and
permanent
tolerances
for
the
combined
residues
of
the
insecticide
imidacloprid
and
its
metabolites
containing
the
6­
chloropyridinyl
moiety,
all
expressed
as
1­[(
6­
chloro­
3­
pyridinyl)
methyl]­
N­
nitro­
2­
imidazolidinimine,
in/
on
nut,
tree,
group
14
at
0.05
ppm;
almond,
hulls
at
4.0
ppm,
and
pistachio
at
0.05
ppm.
 
PP#
5E6921
(
Pomegranate):
an
unconditional
registration
and
a
permanent
tolerance
of
0.90
ppm
for
the
combined
residues
of
the
insecticide
imidacloprid
and
its
metabolites
containing
the
6­
chloropyridinyl
moiety,
all
expressed
as
1­[(
6­
chloro­
3­
pyridinyl)
methyl]­
N­
nitro­
2­
imidazolidinimine,
in/
on
pomegranate.
 
PP#
5E6922
(
Banana):
an
unconditional
registration
and
a
permanent
tolerance
of
0.50
ppm
for
the
combined
residues
of
the
insecticide
imidacloprid
and
its
metabolites
containing
the
6­
chloropyridinyl
moiety,
all
expressed
as
1­[(
6­
chloro­
3­
pyridinyl)
methyl]­
N­
nitro­
2­
imidazolidinimine,
in/
on
banana.
 
PP#
5E6923
(
Herbs,
Subgroup
19A):
an
unconditional
registration
and
permanent
tolerances
for
the
combined
residues
of
the
insecticide
imidacloprid
and
its
metabolites
containing
the
6­
chloropyridinyl
moiety,
all
expressed
as
1­[(
6­
chloro­
3­
pyridinyl)
methyl]­
N­
nitro­
2­
imidazolidinimine,
in/
on
herb,
subgroup
19A,
fresh
at
8.0
ppm;
and
herb,
subgroup
19A,
dry
at
48
ppm.

Notes
to
RD:

 
The
tolerances
for
the
following
commodities
under
Section
(
a)
of
40
CFR
§
180.472
should
be
deleted,
as
they
will
be
covered
under
tolerances
being
recommended
for
in
this
risk
assessment:
banana
(
import
only),
and
coriander.
 
The
time­
limited
tolerances
for
the
following
commodities
under
Section
(
b)
of
40
CFR
§
180.472
should
be
deleted:
almond;
almond,
hulls;
coffee.
The
Section
18
Emergency
Exemption
use
patterns
for
these
commodities
are
the
same
as
those
being
proposed
in
this
risk
assessment.
In
addition,
these
commodities
will
be
covered
under
tolerances
being
recommended
for
in
this
risk
assessment.
Page
6
of
30
 
The
tolerances
for
the
following
commodities
under
Section
(
d)
of
40
CFR
§
180.472
should
be
deleted,
as
they
will
be
covered
under
tolerances
being
recommended
for
in
this
risk
assessment:
safflower,
seed
(
0.05
ppm);
and
safflower,
meal
(
0.50
ppm).

1.0
Background
Imidacloprid
is
an
insecticide
registered
for
uses
on
a
variety
of
crops
for
the
control
of
many
insects,
including
aphids,
cucumber
beetles
and
whiteflies
(
including
Sweet
potato
or
Silverleaf
whitefly).
Imidacloprid
is
a
member
of
the
pyridylmethylamine
class
of
compounds.
Its
mode
of
action
is
the
disruption
of
the
nervous
system
by
acting
as
an
inhibitor
at
nicotinic
acetylcholine
receptors.
Imidacloprid
blocks
the
signals
that
are
induced
by
acetylcholine
at
the
post­
synaptic
membrane,
resulting
in
normal
nerve
function
impairment.

Imidacloprid
is
also
currently
registered
for
use
on
residential
ornamental
lawns,
golf
courses,
and
ornamental
plantings
(
i.
e.,
flowering
plants,
foliage
plants,
herbaceous
perennial
plants,
and
woody
plant,
shrubs
and
trees).
In
addition
to
there
outdoor
uses,
imidacloprid
is
also
registered
for
use
indoors.
It
should
be
noted
that
imidacloprid
is
registered
as
a
pre­
and
post­
construction
termiticide.
However,
due
to
the
low
volatility
and
short
half­
life
of
imidacloprid,
coupled
with
the
fact
that
it
is
used
pre­
and
post­
construction
only,
HED
does
not
expect
there
to
be
potential
for
long­
term
exposure
to
imidacloprid
from
this
use.
Therefore,
long­
term
exposure
assessment
is
not
warranted.

Tolerances
are
currently
established
for
the
combined
residues
of
imidacloprid
and
its
metabolites
containing
the
6­
chloropyridinyl
moiety,
all
expressed
as
the
parent,
under
40
CFR
§
180.472
in/
on
various
plant
and
livestock
commodities.
Section
18
Emergency
Exemption
tolerances
with
expiration/
revocation
dates
are
established
in/
on
plant
commodities
under
40
CFR
§
180.472(
b),
and
indirect
or
inadvertent
tolerances
are
established
as
a
result
of
application
of
the
pesticide
to
growing
crops
and
other
non­
food
crops
under
40
CFR
§
180.472(
d).

The
nomenclature
and
physicochemical
properties
of
imidacloprid
are
presented
below
in
Tables
1.1
and
1.2.
Page
7
of
30
Table
1.1
Test
Compound
Nomenclature.

Chemical
Structure
Common
Name
Imidacloprid
Company
experimental
name
BAY
NTN
33893
IUPAC
name
(
EZ)­
1­(
6­
chloro­
3­
pyridylmethyl)­
N­
nitroimidazolidin­
2­
ylideneamine
CAS
name
1­[(
6­
chloro­
3­
pyridinyl)
methyl]­
N­
nitro­
2­
imidazolidinimine
CAS
#
138261­
41­
3
End­
use
products/(
EP)
Admire
®
2
Flowable
(
2F),
Provado
®
1.6
Flowable
(
1.6F),
Gaucho
®
480
Flowable,
Gaucho
®
550
Flowable,
Gaucho
®
600
SC,
Gaucho
®
550
SC,
Provado
®

75%
Solupak,
Provado
®
70WG
Table
1.2
Physicochemical
Properties
of
the
Technical
Grade
Test
Compound.

Parameter
Value
Reference
Melting
point
144
oC
pH
5
to
11
Specific
gravity
1.54
(@
23
oC)

Water
solubility
(
g/
L
at
20
oC)
0.61
Solvent
solubility
(
g/
L
at
20
oC)
Dichloromethane:
55,
Isopropanol:
1.2,
Toluene:
0.68,
n­
hexane:
<
0.1
Vapor
pressure
(
mPa
at
20
oC)
4
x
10­
7
Octanol/
water
partition
coefficient
[
Log(
KOW)]
0.57
(
21
oC)

UV/
visible
absorption
spectrum
Not
provided.
The
Pesticide
Manual
Twelfth
Edition
(
2000)

2.0
Hazard
Characterization/
Toxicity
Endpoint
Selection
2.1
Hazard
Characterization:
Imidacloprid
has
low
acute
toxicity
via
the
dermal
and
inhalation
routes
and
moderate
acute
toxicity
via
the
oral
route.
It
is
not
an
eye
or
dermal
irritant
and
is
not
a
dermal
sensitizer.
The
nervous
system
is
the
primary
target
organ
of
imidacloprid.
Nervous
system
effects
evidenced
as
changes
in
clinical
signs
and
Functional
Observation
Battery
(
FOB)
assessments
were
seen
in
rat
acute
and
subchronic
neurotoxicity
studies.
These
effects
included
decreased
motor
and
locomotor
activities,
tremors,
gait
abnormalities,
increased
righting
reflex
impairments
and
body
temperature,
and
decreased
number
of
rears
and
response
to
stimuli
and
decreases
in
forelimb
and
hindlimb
grip
strength.
Also,
in
the
rat
developmental
neurotoxicity
study,
a
decrease
in
the
caudate/
putamen
width
was
noted
in
female
pups.
Retinal
atrophy
was
seen
in
high­
dose
females
in
the
rat
combined
chronic
toxicity/
carcinogenicity
N
N
N
Cl
C
H2
N
O2N
H
Page
8
of
30
study.
No
nervous
system
effects
were
noted
in
the
mouse
carcinogenicity
or
the
reproduction
and
developmental
studies
or
in
the
rabbit
dermal
or
rat
inhalation
studies.
The
dog
was
less
sensitive
to
the
effects
of
imidacloprid.
No
effects
were
noted
up
to
the
highest
dose
tested
in
the
chronic
toxicity
study.
The
rabbit
appeared
to
be
very
sensitive
as
there
was
increased
mortality
in
the
oral
developmental
study
at
the
highest
dose
tested.
Increased
incidence
of
mineralized
particles
in
the
thyroid
colloid
was
noted
in
the
rat
combined
chronic
toxicity/
carcinogenicity
study.
Body
weight
decrements
were
noted
in
the
rat
and/
or
mouse
chronic
and
carcinogenicity
studies,
the
rat
subchronic
neurotoxicity
study,
and
the
developmental,
developmental
neurotoxicity
and
reproduction
studies.
No
effects
were
observed
in
the
rabbit
dermal
or
rat
inhalation
studies.
There
was
no
evidence
of
carcinogenic
potential
in
either
the
rat
chronic
toxicity/
carcinogenicity
or
mouse
carcinogenicity
studies
and
no
concern
for
mutagenicity.
There
was
no
evidence
of
increased
qualitative
or
quantitative
susceptibility
of
rats
or
rabbits
to
in
utero
exposure
to
imidacloprid
and
no
evidence
of
qualitative
or
quantitative
increased
susceptibility
of
rat
offspring
in
the
reproduction
study.
There
was
evidence
of
an
increased
qualitative
susceptibility
in
the
rat
developmental
neurotoxicity
study.
At
the
highest
dose
tested,
maternal
effects
consisted
largely
of
slight
decreases
in
food
consumption
and
body
weight
gain
during
early
lactation,
while
pup
effects
included
decreased
body
weight;
decreased
motor
activity;
decreased
caudate/
putamen
width,
females
only
[
postnatal
days
(
PNDs)
11
and
adult];
and
slight
changes
in
performance
in
the
water
maze,
males
only,
at
the
same
dose.

On
11/
10/
93,
the
Reference
Dose
(
RfD)/
Peer
Review
Committee
classified
imidacloprid
as
a
"
Group
E"
chemical,
no
evidence
of
carcinogenicity
for
humans,
by
all
routes
of
exposure
based
upon
lack
of
evidence
of
carcinogenicity
in
rats
and
mice.

2.2
Toxicity
Endpoint
Selection:
The
doses
and
toxicological
endpoints
selected
for
various
exposure
scenarios
are
summarized
in
Table
2.2.1.

Table
2.2.1
Summary
of
Toxicological
Dose
and
Endpoints
for
Imidacloprid
for
Use
in
Human
Health
Risk
Assessment1.

Exposure
Scenario
Dose
Used
in
Risk
Assessment,
UF
*
FQPA
SF
and
Level
of
Concern
for
Risk
Assessment
Study
and
Toxicological
Effects
Acute
Dietary
all
populations
LOAEL
=
42
mg/
kg/
day
UF
=
3002
Acute
RfD
=
0.14
mg/
kg
FQPA
SF
=
1X
aPAD
=
aRfD
FQPA
SF
=
0.14
mg/
kg
Acute
neurotoxicity
­
rat
LOAEL
=
42
mg/
kg,
based
upon
the
decrease
in
motor
and
locomotor
activities
observed
in
females.

Chronic
Dietary
all
populations
NOAEL
=
5.7
mg/
kg/
day
UF
=
100
Chronic
RfD
=
0.057
mg/
kg/
day
FQPA
SF
=
1X
cPAD
=
cRfD
FQPA
SF
=
0.057
mg/
kg/
day
Combined
chronic
tox/
carcinogenicity
­
rat
LOAEL
=
16.9
mg/
kg/
day,
based
upon
increased
incidence
of
mineralized
particles
in
thyroid
colloid
in
males.
Page
9
of
30
Table
2.2.1
Summary
of
Toxicological
Dose
and
Endpoints
for
Imidacloprid
for
Use
in
Human
Health
Risk
Assessment1.

Exposure
Scenario
Dose
Used
in
Risk
Assessment,
UF
*
FQPA
SF
and
Level
of
Concern
for
Risk
Assessment
Study
and
Toxicological
Effects
Short­
Term
Oral
(
1­
30
days)
oral
study
NOAEL
=
10
mg/
kg/
day
LOC
for
MOE
=
100
(
Residential,
includes
the
FQPA
SF)
Developmental
toxicity
­
rat
Maternal
LOAEL
=
30
mg/
kg/
day,
based
upon
decreased
body
weight
gain
and
corrected
body
weight
gain.

Intermediate­
Term
Oral
(
1­
6
months)
oral
study
NOAEL
=
9.3
mg/
kg/
day
LOC
for
MOE
=
100
(
Residential,
includes
the
FQPA
SF)
Subchronic
neurotoxicity
­
rat
LOAEL
=
63.3
mg/
kg/
day,
based
upon
decreased
body
weight
gain.

Short­
Term
Dermal
(
1­
30
days)
oral
study
NOAEL
=
10
mg/
kg/
day
(
dermal
absorption
rate
=
7.2%)
3
LOC
for
MOE
=
100
(
Occupational)

LOC
for
MOE
=
100
(
Residential,
includes
the
FQPA
SF)
Developmental
toxicity
­
rat
Maternal
LOAEL
=
30
mg/
kg/
day,
based
upon
decreased
body
weight
gain
and
corrected
body
weight
gain.

Intermediate­
Term
Dermal
(
1­
6
months)
oral
study
NOAEL
=
9.3
mg/
kg/
day
(
dermal
absorption
rate
=
7.2%)
3
LOC
for
MOE
=
100
(
Occupational)

LOC
for
MOE
=
100
(
Residential,
includes
the
FQPA
SF)
Subchronic
neurotoxicity
­
rat
LOAEL
=
63.3
mg/
kg/
day,
based
upon
decreased
body
weight
gain.

Long­
Term
Dermal
(>
6
months)
oral
study
NOAEL
=
5.7
mg/
kg/
day
(
dermal
absorption
rate
=
7.2%)
3
LOC
for
MOE
=
100
(
Occupational)

LOC
for
MOE
=
100
(
Residential,
includes
the
FQPA
SF)
Combined
chronic
tox/
carcinogenicity
­
rat
LOAEL
=
16.9
mg/
kg/
day,
based
upon
increased
incidence
of
mineralized
particles
in
thyroid
colloid
in
males.

Short­
Term
Inhalation
(
1­
30
days)
oral
study
NOAEL
=
10
mg/
kg/
day
(
inhalation
absorption
rate
=
100%)
LOC
for
MOE
=
100
(
Occupational)

LOC
for
MOE
=
100
(
Residential,
includes
the
FQPA
SF)
Developmental
toxicity
­
rat
Maternal
LOAEL
=
30
mg/
kg/
day,
based
upon
decreased
body
weight
gain
and
corrected
body
weight
gain.

Intermediate­
Term
Inhalation
(
1­
6
months)
oral
study
NOAEL
=
9.3
mg/
kg/
day
(
inhalation
absorption
rate
=
100%)
LOC
for
MOE
=
100
(
Occupational)

LOC
for
MOE
=
100
(
Residential,
includes
the
FQPA
SF)
Subchronic
neurotoxicity
­
rat
LOAEL
=
63.3
mg/
kg/
day,
based
upon
decreased
body
weight
gain.
Page
10
of
30
Table
2.2.1
Summary
of
Toxicological
Dose
and
Endpoints
for
Imidacloprid
for
Use
in
Human
Health
Risk
Assessment1.

Exposure
Scenario
Dose
Used
in
Risk
Assessment,
UF
*
FQPA
SF
and
Level
of
Concern
for
Risk
Assessment
Study
and
Toxicological
Effects
Long­
Term
Inhalation
(>
6
months)
oral
study
NOAEL
=
5.7
mg/
kg/
day
(
inhalation
absorption
rate
=
100%)
LOC
for
MOE
=
100
(
Occupational)

LOC
for
MOE
=
100
(
Residential,
includes
the
FQPA
SF)
Combined
chronic
tox/
carcinogenicity
­
rat
LOAEL
=
16.9
mg/
kg/
day,
based
upon
increased
incidence
of
mineralized
particles
in
thyroid
colloid
in
males.

Cancer
(
oral,
dermal,
inhalation)
no
evidence
of
carcinogenicity
for
humans
Not
applicable
No
evidence
of
carcinogenicity
in
rats
and
mice.

1
UF
=
uncertainty
factor,
NOAEL
=
no
observed
adverse
effect
level,
LOAEL
=
lowest
observed
adverse
effect
level,
PAD
=
population
adjusted
dose
(
a
=
acute,
c
=
chronic)
RfD
=
reference
dose,
MOE
=
margin
of
exposure,
LOC
=
level
of
concern.
2
A
300­
fold
uncertainty
factor
(
3x
UFL;
and
10x
for
interspecies
extrapolation
and
10x
for
intraspecies
variation)
was
incorporated
in
the
aRfD.
A
3X
uncertainty
factor
for
the
use
of
a
LOAEL
was
judged
to
be
adequate
(
as
opposed
to
a
10X)
because:
1)
the
LOAEL
(
42
mg/
kg)
is
comparable
to
the
LOAELs
seen
in
adults
in
the
developmental
rat
study
(
30
mg/
kg/
d)
and
the
two­
generation
reproduction
study
[
47/
52
mg/
kg/
d
(
male/
female)]
and
in
the
offspring
in
the
DNT
study
(
55
mg/
kg/
d);
2)
the
extrapolated
NOAEL
of
14
mg/
kg
(
42/
3
=
14)
is
comparable
to
the
NOAEL
of
20
mg/
kg/
d
established
in
the
offspring
in
the
DNT;
and,
3)
the
neurotoxic
effects
in
this
study
showed
a
good
dose
response
which
resulted
in
minimal
effects
on
motor
activity
and
locomotor
activity
at
the
LOAEL
(
memo,
J.
Tyler
et
al.,
3/
4/
03;
D286101).
3
A
dermal
absorption
factor
of
7%
was
used
for
risk
assessment
purposes.

3.0
Food
Quality
Protection
Act
(
FQPA)
Assessment
On
10/
08/
2002,
the
HED
Hazard
Identification
Assessment
Review
Committee
(
HIARC)
evaluated
the
potential
for
increased
susceptibility
of
infants
and
children
from
exposure
to
imidacloprid
according
to
the
February
2002
OPP
10X
guidance
document.
The
HIARC
concluded
that
the
toxicology
database
was
complete
for
FQPA
purposes
and
that
there
are
no
residual
uncertainties
for
pre­/
post­
natal
toxicity
(
Memo,
D.
Nixon,
10/
31/
02;
TXR
NO.
0051292).
Based
on
the
hazard
data,
the
HIARC
recommended
the
FQPA
SF
be
reduced
to
1x.
The
imidacloprid
risk
assessment
team
evaluated
the
quality
of
the
exposure
data;
and,
based
upon
these
data,
recommended
that
the
FQPA
safety
factor
be
reduced
to
1x
(
Memo,
J.
Tyler,
3/
4/
03;
D286101).

HED
notes
that
a
300­
fold
uncertainty
factor
(
3x
UFL;
and
10x
for
interspecies
extrapolation
and
10x
for
intraspecies
variation)
was
incorporated
in
the
aRfD.
A
3X
uncertainty
factor
for
the
use
of
a
LOAEL
was
judged
to
be
adequate
(
as
opposed
to
a
10X)
because:
1)
the
LOAEL
(
42
mg/
kg)
is
comparable
to
the
LOAELs
seen
in
adults
in
the
developmental
rat
study
(
30
mg/
kg/
d)
and
the
two­
generation
reproduction
study
[
47/
52
mg/
kg/
d
(
male/
female)]
and
in
the
offspring
in
the
DNT
study
(
55
mg/
kg/
d);
2)
the
extrapolated
NOAEL
of
14
mg/
kg
(
42/
3
=
14)
is
comparable
to
the
NOAEL
of
20
mg/
kg/
d
established
in
the
offspring
in
the
DNT;
and,
3)
the
neurotoxic
effects
in
this
study
showed
a
good
dose
response
which
resulted
in
minimal
effects
on
motor
activity
and
locomotor
activity
at
the
LOAEL
(
memo,
J.
Tyler
et
al.,
3/
4/
03;
D286101).
Page
11
of
30
4.0
Endocrine
Disruption
EPA
is
required
under
the
Federal
Food
Drug
and
Cosmetic
Act
(
FFDCA),
as
amended
by
FQPA,
to
develop
a
screening
program
to
determine
whether
certain
substances
(
including
all
pesticide
active
and
other
ingredients)
"
may
have
an
effect
in
humans
that
is
similar
to
an
effect
produced
by
a
naturally
occurring
estrogen,
or
other
such
endocrine
effects
as
the
Administrator
may
designate."
Following
the
recommendations
of
its
Endocrine
Disruptor
Screening
and
Testing
Advisory
Committee
(
EDSTAC),
EPA
determined
that
there
were
scientific
bases
for
including,
as
part
of
the
program,
the
androgen
and
thyroid
hormone
systems,
in
addition
to
the
estrogen
hormone
system.
EPA
also
adopted
EDSTAC's
recommendation
that
the
Program
include
evaluations
of
potential
effects
in
wildlife.
For
pesticide
chemicals,
EPA
will
use
FIFRA
and,
to
the
extent
that
effects
in
wildlife
may
help
determine
whether
a
substance
may
have
an
effect
in
humans,
FFDCA
has
authority
to
require
the
wildlife
evaluations.
As
the
science
develops
and
resources
allow,
screening
of
additional
hormone
systems
may
be
added
to
the
Endocrine
Disruptor
Screening
Program
(
EDSP).

When
the
appropriate
screening
and/
or
testing
protocols
being
considered
under
the
Agency's
EDSP
have
been
developed,
imidacloprid
may
be
subjected
to
additional
screening
and/
or
testing
to
better
characterize
effects
related
to
endocrine
disruption.

5.0
Registered/
Proposed
Application
Scenarios
5.1
Registered
Uses:
Tolerances
are
currently
established
for
the
combined
residues
of
imidacloprid
and
its
metabolites
containing
the
6­
chloropyridinyl
moiety,
all
expressed
as
the
parent,
under
40
CFR
§
180.472
in/
on
various
plant
and
livestock
commodities.
Section
18
Emergency
Exemption
tolerances
with
expiration/
revocation
dates
are
established
in/
on
plant
commodities
under
40
CFR
§
180.472(
b),
and
indirect
or
inadvertent
tolerances
are
established
as
a
result
of
application
of
the
pesticide
to
growing
crops
and
other
non­
food
crops
under
40
CFR
§
180.472(
d).

5.2
Proposed
Uses:
For
the
proposed
uses,
specimen
labels
were
provided
for
the
following
products:
Admire
®
2
Flowable
(
2F)
Insecticide,
a
2
lb
ai/
gal
flowable
concentrate
(
FlC;
EPA
Reg.
No.
3125­
422);
Gaucho
®
480
Flowable,
a
4
lb
ai/
gal
FlC
(
EPA
Reg.
No.
7501­
155);
Gaucho
®
600
Flowable,
a
5
lb
ai/
gal
FlC
(
EPA
Reg.
No.
7501­
173);
Gaucho
®
550
SC
Insecticide,
a
4.6
lb
ai/
gal
(
EPA
Reg.
No.
264­
827);
Gaucho
®
600
SC
Insecticide,
a
5
lb
ai/
gal
(
EPA
Reg.
No.
264­
828);
Provado
®
1.6
Flowable
(
1.6F)
Insecticide,
a
1.6
lb
ai/
gal
FlC
(
EPA
Reg.
No.
3125­
457);
Provado
®
75%
Solupak,
a
75.0%
ai
wettable
powder
(
WP;
EPA
Reg.
No.
264­
761);
and
Provado
®
70
Wettable
Granular
(
WG)
Insecticide,
a
70%
ai
product
(
EPA
Reg.
No.
264­
823).

The
proposed
use
directions
for
caneberry,
subgroup
13A
(
PP#
3E6543);
coffee
(
PP#
3E6561);
sunflower
and
oilseed
crops
(
PP#
3E6738);
sugar
apple
and
related
crops
(
PP#
3E6760);
banana
(
PP#
5E6922);
and
herbs
(
PP#
5E6923)
are
adequate
and
are
supported
by
the
residue
data
on
these
crops.
Page
12
of
30
For
the
proposed
use
on
tree
nuts,
including
pistachios
(
PP#
5E6920),
there
is
a
discrepancy
between
the
proposed
label
and
use
directions
provided
for
Provado
®
1.6F
under
Section
B.
The
label
specifies
a
maximum
single
application
rate
of
0.1
lb
ai/
A
(
8.0
fl.
oz.
product/
A)
and
the
text
specifies
a
rate
of
0.0875
lb
ai/
A
(
7.0
fl.
oz.
product/
A).
Additionally,
the
available
crop
field
trial
data
do
not
support
the
proposed
0.5
lb
ai/
A
application
rate
on
the
Admire
®
2F
label
as
the
field
trials
were
conducted
at
0.35
lb
ai/
A.
The
Provado
®
1.6F
label
should
be
amended
to
clarify
the
maximum
application
rate,
and
the
Admire
®
2F
label
should
be
revised
to
specify
a
maximum
total
application
rate
of
0.35
lb
ai/
A.

For
the
proposed
use
on
pomegranate
(
PP#
5E6921),
the
available
crop
field
trial
data
do
not
support
the
proposed
0­
day
preharvest
interval
(
PHI)
on
the
Admire
®
2F
label
as
the
field
trials
were
conducted
at
a
7­
day
PHI.
The
Admire
®
2F
label
should
be
revised
to
specify
a
7­
day
PHI.

6.0
Residue
Chemistry
Considerations
Residue
chemistry
memo
­
DP#
322834,
J.
Tyler,
6/
14/
06
6.1
Nature
of
the
Residue
 
Plants
and
Livestock:
Data
concerning
the
metabolism
of
imidacloprid
in
apples,
potatoes,
tomatoes,
eggplant,
cottonseed,
field
corn,
tobacco,
ruminants,
and
poultry
have
been
submitted
and
reviewed
in
conjunction
with
PP#
3F4169/
3H5655
(
Memos,
F.
Griffith,
9/
20/
93,
D185148;
6/
8/
94,
D200233;
and
2/
29/
96,
D217632).
The
results
of
the
aforementioned
plant
and
livestock
metabolism
studies
were
presented
to
the
HED
Metabolism
Committee
on
6/
22/
93
(
Memo,
F.
Griffith,
6/
18/
93,
No
Barcode).
The
nature
of
imidacloprid
residues
in
plants
and
livestock
is
adequately
understood.
The
residue
of
concern
in
plants
and
livestock
is
imidacloprid
and
its
metabolites
containing
the
6­
chloropyridinyl
moiety,
all
expressed
as
the
parent,
as
specified
in
40
CFR
§
180.472.

6.2
Residue
Analytical
and
Multiresidue
Methods
(
MRM):
Adequate
enforcement
methods
are
available
for
determination
of
imidacloprid
residues
of
concern
in
plant
(
Bayer
Gas
Chromatography/
Mass
Spectrometry
(
GC/
MS)
Method
00200)
and
livestock
commodities
(
Bayer
GC/
MS
Method
00191).
These
methods
have
undergone
successful
EPA
petition
method
validations
(
PMVs),
and
the
registrant
has
fulfilled
the
remaining
requirements
for
additional
raw
data,
method
validation,
independent
laboratory
validation
(
ILV),
and
an
acceptable
confirmatory
method
(
High
Performance
Liquid
Chromatography/
Ultraviolet
(
HPLC/
UV)
Method
00357)
(
Memos,
F.
Griffith,
6/
18/
93,
D187911;
6/
1/
94,
D202113;
6/
8/
94,
D200233;
6/
8/
95,
D213252;
and
12/
18/
95;
D221591).
The
validated
limit
of
detection
(
LOD)
and
limit
of
quantitation
(
LOQ)
for
the
GC/
MS
Method
00200
are
0.01
and
0.05
ppm,
respectively,
in
plant
commodities.

Bayer
GC/
MS
Method
00200
is
a
common
moiety
method
that
uses
a
3:
1
methanol/
1%
sulfuric
acid
extraction,
filtering
through
Celite/
filter
paper,
XAD­
4
resin
column
clean­
up,
oxidation
of
parent
and
metabolites
to
6­
chloronicotinic
acid
(
6­
CNA)
by
refluxing
in
a
32%
sodium
hydroxide
(
NaOH)
solution
combined
with
a
5%
potassium
permanganate
(
KMnO4)
solution,
Page
13
of
30
extracted
3
times
with
methyl
t­
butyl
ether,
then
N­
methyl­
N­(
trimethylsilyl)
trifluroacetamide
(
MSFTA)
derivatization
for
1
hour,
and
determination
by
capillary
GC/
MS
selective
ion
monitoring
at
m/
z
214,
216,
170,
and
140.

Samples
in
the
submitted
crop
field
trial
studies
were
analyzed
for
combined
residues
of
imidacloprid
and
its
metabolites
containing
6­
chloropyridinyl
moiety,
all
expressed
as
the
parent,
using
a
modification
of
Bayer
GC/
MS
Method
00200.
In
all
studies,
method
and/
or
concurrent
method
recovery
data
were
generated
using
untreated
samples
collected
from
the
respective
field
trials.
Control
samples
were
fortified
with
an
equimolar
mixture
of
imidacloprid
and
metabolites
5­
hydroxy
imidacloprid,
imidacloprid
olefin,
des
nitro
imidacloprid
and
6­
CNA,
and
analyzed
either
separately
(
method
validation)
or
concurrently
(
concurrent
recovery)
with
field
treated
samples.
Concurrent
method
recovery
data
were
acceptable.

Bayer
Corporation
previously
submitted
adequate
MRM
recovery
data
for
imidacloprid
and
the
metabolites
5­
hydroxy
imidacloprid,
imidacloprid
olefin,
des
nitro
imidacloprid
and
6­
CNA
through
Food
and
Drug
Administration
(
FDA)
Protocols
A
through
E
(
Memos,
F.
Griffith,
6/
18/
93,
D187911;
7/
15/
93,
D193027;
6/
8/
94,
D200233;
and
6/
22/
94,
D194206).
Imidacloprid
and
its
metabolites
were
not
recoverable
by
these
methods.
The
results
of
the
MRM
testing
for
imidacloprid
were
forwarded
to
FDA
for
inclusion
in
the
Pesticide
Analytical
Method
Volume
I
(
PAM
I)
(
Memo,
F.
Griffith
7/
15/
93,
D193005).

6.3
Storage
Stability
Data:
Adequate
storage
stability
data
have
been
submitted
and
reviewed
by
HED.
Residues
of
imidacloprid
have
been
shown
to
be
stable
in
a
variety
of
raw
agricultural
commodities
(
RACs)
for
up
to
2
years
(~
728
days)
of
storage
(
Memo,
F.
Griffith
6/
8/
95;
PP#
5F04480).
In
addition,
analysis
of
samples
from
the
14C­
imidacloprid
plant
metabolism
studies
for
corn,
cotton,
apples,
and
potatoes
showed
no
loss
of
imidacloprid
and
its
major
metabolites
during
a
period
of
2
years
of
frozen
storage
(
PP#
3F04169;
Memo,
F.
Griffith,
9/
21/
93,
D185148).
The
available
storage
stability
data
are
adequate
to
support
the
proposed
uses.
Although
samples
in
the
crop
field
trial
study
for
chives
were
stored
frozen
for
868
days
prior
to
being
analyzed,
the
available
storage
stability
data
indicate
that
residues
of
imidacloprid
and
its
metabolites
containing
the
6­
chloropyridil
moiety
should
still
be
stable
for
this
interval.

6.4
Meat,
Milk,
Poultry
and
Eggs:
The
only
livestock
feed
items
associated
with
the
proposed
uses
are
sunflower
seed
meal
(
cattle,
poultry
and
swine
feed
item)
and
almond
hulls
(
cattle
feed
item
only).
Based
on
the
current
livestock
tolerances,
HED
concludes
that
the
proposed
uses
on
sunflowers
and
almonds
will
not
have
a
significant
effect
on
the
previously
calculated
maximum
theoretical
dietary
burden
(
MTDB),
and
an
increase
in
livestock
tolerances
is
not
needed.
Page
14
of
30
6.5
Crop
Field
Trials
and
Processed
Food
and
Feed:

Table
6.5.1
Summary
of
Residue
Data
from
Crop
Field
Trials
with
Imidacloprid.

Residue
Levels
(
ppm)
2
Commodity
Total
Applic.
Rate
(
lb
ai/
A)
PHI
(
days)
N
Min.
Max.
HAFT1
Mean
Std.
Dev.

PP#
3E6543
 
Caneberry,
Subgroup
13A
(
proposed
use:
0.5
lb
ai/
A/
year;
7­
day
PHI)

7
4
<
0.05
<
0.05
­
­
­

14
4
<
0.05
<
0.05
­
­
­

28
4
<
0.05
<
0.05
­
­
­

42
4
<
0.05
<
0.05
­
­
­
Raspberry
0.5
56
4
<
0.05
<
0.05
­
­
­

PP#
3E6561
 
Coffee
(
proposed
use:
0.5
lb
ai/
A/
year;
7­
day
PHI)

Coffee
green
bean
0.5
6­
7
9
0.172
0.482
0.473
0.302
0.122
PP#
3E6738
­
Sunflower
and
Oilseed
Crops
(
proposed
use:
1.0
lb
ai/
cwt/
year;
seed
treatment)

Sunflower
seeds
1.0
lb
ai/
cwt
NA3
6
<
0.05
<
0.05
<
0.05
<
0.05
NA
PP#
3E6760
 
Sugar
Apple,
Cherimoya,
Atemoya,
Custard
Apple,
Ilama,
Soursop,
Biriba
(
proposed
use:
0.5
lb
ai/
A/
year;
14­
day
PHI)

Sugar
Apple
0.5
14­
15
6
<
0.05
0.170
0.12
0.099
0.054
PP#
5E6920
 
Tree
Nuts,
Including
Pistachios
(
proposed
use:
0.5
lb
ai/
A/
year;
7­
day
PHI)

Almond
hulls
0.35
7
5
1.41
2.59
2.59
2.06
0.57
Almond
nutmeats
0.35
7
5
<
0.01
<
0.01
­
­
­

Pecan
nutmeats
0.35
7
5
<
0.01
<
0.01
­
­
­

PP#
5E6921
 
Pomegranate
(
proposed
use:
0.5
lb
ai/
A/
year;
0­
day
PHI)

Pomegranate
fruit
0.60
7
6
0.41
0.55
0.51
0.45
0.02
PP#
5E6922
 
Banana
(
proposed
use:
0.50
lb
ai/
A/
year;
0­
day
PHI)

Banana
fruit
0.50
0
10
0.10
0.53
0.52
0.39
0.15
PP#
5E6923
 
Herbs
(
proposed
use:
Admire
®
2F
­
0.375
lb
ai/
A/
year;
Provado
®
1.6F
 
0.132
lb
ai/
A,
7­
day
PHI;
total
application
rate
not
to
exceed
0.50
lb
ai/
A,
regardless
of
product)

Fresh
Basil
0.50
7
6
1.11
4.08
3.98
3.02
1.43
Dried
Basil
0.50
7
1
13.9
13.9
13.9
13.9
­

Chives
0.50
7
8
1.81
5.43
5.19
3.59
1.28
1
Residue
values
expressed
as
imidacloprid
equivalents.
2
HAFT
=
Highest
Average
Field
Trial.
3
NA
=
Not
Applicable.

PP#
3E6543
(
Caneberry):
The
crop
field
trial
data
for
raspberry
are
classified
as
unacceptable
as
only
one
sample
of
raspberry
was
collected
from
each
plot.
However,
as
all
residues
were
<
0.05
ppm
(<
LOQ),
the
data
are
considered
to
be
adequate.
The
data
do
not
satisfy
the
guideline
requirement
for
crop
field
trials
(
Residue
Chemistry
Guidelines
OPPTS
860.1500).
Two
field
trials
were
conducted
in
Region
10
(
CA)
during
the
2000
growing
season.
However,
for
a
tolerance
on
caneberry,
current
guidelines
recommend
a
total
of
five
field
trials
on
either
blackberry
or
raspberry
in
Region
1
(
1
trial),
Region
5
(
1
trial),
and
Region
10
(
3
trials).
The
Page
15
of
30
residue
data
are
adequate
to
support
a
permanent
tolerance
of
0.05
ppm
for
the
combined
residues
of
imidacloprid
and
its
metabolites
containing
the
6­
chloropyridinil
moiety,
all
expressed
as
the
parent,
in/
on
caneberry
subgroup
13A.
However,
the
registration
should
be
conditional
until
the
submission
of
additional
crop
field
trial
data
on
either
blackberry
or
raspberry
from
Region
1
(
1
trial),
Region
5
(
1
trial)
and
Region
10
(
1
trial).
Two
samples
should
be
collected
from
each
trial.

PP#
3E6561
(
Coffee):
The
crop
field
trial
data
for
coffee
are
classified
as
acceptable
and
satisfy
guideline
requirement
for
crop
field
trials
(
Residue
Chemistry
Guidelines
OPPTS
860.1500).
The
residue
data
support
the
establishment
of
a
permanent
tolerance
of
0.80
ppm
for
the
combined
residues
of
imidacloprid
and
its
metabolites
containing
the
6­
chloropyridinil
moiety,
all
expressed
as
the
parent,
in/
on
coffee,
green
bean.
A
revised
Section
F
should
be
submitted
to
include
the
HED­
recommended
tolerance.

PP#
3E6738
(
Sunflower
Seed
and
Related
Crops):
The
crop
field
trial
data
for
sunflower
seed
are
classified
as
unacceptable
as
only
one
sample
was
collected
from
each
site;
however,
the
data
satisfy
the
guideline
requirement
for
crop
field
trial
locations
(
Residue
Chemistry
Guidelines
OPPTS
860.1500).
As
all
residues
were
<
0.05
ppm
(<
LOQ),
the
data
are
adequate
to
support
the
proposed
tolerances.
HED
has
determined
the
following
("
Reviewer's
Guide...",
B.
Schneider,
6/
14/
02):

"
A
new
Oilseed
Crop
Group
20
is
being
established
to
harmonize
with
Canada's
Crop
Group
20.
The
representative
commodities
for
this
crop
group
are
rapeseed
(
canola
varieties
only)
and
sunflower,
seed.
Members
of
this
Crop
Group
will
be
rapeseed,
seed;
Indian
rapeseed;
Indian
mustard,
seed;
field
mustard,
seed;
black
mustard,
seed;
flax,
seed;
sunflower,
seed;
safflower,
seed;
and
crambe,
seed.
Borage,
seed
will
also
be
added
as
a
member
if
Canada
agrees
to
also
add
it
to
their
Crop
Group
20.

Until
the
Federal
Register
Notice
is
issued
revising
the
Crop
Group
Regulation
to
establish
the
Oilseed
Crop
Group
20,
tolerances
for
the
representative
commodities
[
rapeseed
(
canola,
seed)
and
sunflower,
seed]
as
well
as
all
members
of
the
crop
group
will
be
listed
individually,
and
the
tolerance
level
will
be
identical."

Adequate
canola
residue
data
have
been
submitted
by
the
petitioner
and
reviewed
by
HED
in
conjunction
with
PP#
5F4534
(
Memos,
F.
Griffith,
9/
25/
95,
D216234;
and
Y.
Donovan,
7/
12/
00,
D224074).
No
total
imidacloprid
residues
were
detected
in
any
of
the
control
canola
seed
to
the
LOD
of
<
0.01
ppm.
Total
imidacloprid
residues
were
<
LOQ.

The
available
sunflower
seed
and
canola
data
support
the
establishment
of
permanent
tolerances
of
0.05
ppm
for
the
combined
residues
of
imidacloprid
and
its
metabolites
containing
the
6­
chloropyridinil
moiety,
all
expressed
as
the
parent,
in/
on
rapeseed,
seed;
Indian
rapeseed,
seed;
Indian
mustard,
seed;
field
mustard,
seed;
black
mustard,
seed;
flax,
seed;
sunflower,
seed;
safflower,
seed;
crambe,
seed;
and
borage,
seed.
Page
16
of
30
PP#
3E6760
(
Sugar
Apple
and
Related
Crops):
The
crop
field
trial
data
for
sugar
apple
are
classified
as
acceptable
and
satisfy
the
guideline
requirement
for
crop
field
trials
(
Residue
Chemistry
Guidelines
OPPTS
860.1500.
HED
has
determined
the
following
("
Reviewer's
Guide...,"
B.
Schneider,
6/
14/
02):

General
Commodity
Specific
Commodities
included
in
definition
Sugar
apple
Sugar
apple,
atemoya,
custard
apple,
cherimoya,
ilama,
soursop,
and
birida.

Therefore,
the
residue
data
on
sugar
apple
support
permanent
tolerances
of
0.30
ppm
for
the
combined
residues
of
imidacloprid
and
its
metabolites
containing
the
6­
chloropyridinil
moiety,
all
expressed
as
the
parent,
in/
on
on
sugar
apple,
cherimoya,
atemoya,
custard
apple,
ilama,
soursop,
and
biriba.
A
revised
Section
F
should
be
submitted
to
include
the
HEDrecommended
tolerances.

PP#
5E6920
(
Tree
Nuts,
Including
Pistachios):
The
crop
field
trial
data
for
almonds
and
pecans
are
classified
as
unacceptable
because
only
one
sample
of
treated
unshelled
nuts
were
collected
from
each
plot.
However,
as
the
majority
of
the
residues
were
<
LOQ
for
almond
and
pecan
nutmeats,
the
available
data
are
adequate
to
support
the
proposed
tolerances.
The
data
satisfy
the
guideline
requirement
for
crop
field
trial
locations
(
Residue
Chemistry
Guidelines
OPPTS
860.150.
The
trials
were
conducted
at
0.35
lb
ai/
A,
which
is
1x
the
proposed
rate
for
Provado
®

1.6F,
but
only
0.7x
the
proposed
rate
for
Admire
®
2F.
Provided
the
Admire
®
2F
label
is
revised
to
specify
a
maximum
total
application
rate
of
0.35
lb
ai/
A,
the
residue
data
are
adequate
to
support
the
following
tolerances
for
the
combined
residues
of
imidacloprid
and
its
metabolites
containing
the
6­
chloropyridinil
moiety,
all
expressed
as
the
parent:
almond,
hulls
(
4.0
ppm);
nut,
tree,
group
14
(
0.05
ppm);
and
pistachio
(
0.05
ppm).
The
recommended
tolerances
for
nutmeats
are
based
on
the
validated
LOQ
(
0.05
ppm)
for
the
analytical
enforcement
method.
In
addition,
this
tolerance
allows
for
harmonization
with
the
Codex
maximum
residue
limit
(
MRL).
Revised
Section
F
should
be
submitted
to
include
the
HED­
recommended
tolerances.

PP#
5E6921
(
Pomegranate):
The
crop
field
trial
data
on
pomegranate
are
classified
as
acceptable
and
satisfy
the
guideline
requirement
for
crop
field
trials
(
Residue
Chemistry
Guidelines
OPPTS
860.1500).
The
data
support
a
permanent
tolerance
of
0.90
for
the
combined
residues
of
imidacloprid
and
its
metabolites
containing
the
6­
chloropyridinil
moiety,
all
expressed
as
the
parent,
in/
on
pomegranate.
A
revised
Section
F
should
be
submitted
to
include
the
HEDrecommended
tolerance.

PP#
5E6922
(
Banana):
The
crop
field
trial
data
for
banana
are
classified
as
acceptable,
but
do
not
satisfy
the
guideline
requirement
for
crop
field
trial
locations
for
a
tolerance
on
banana
(
Residue
Chemistry
Guidelines
OPPTS
860.1500).
A
total
of
five
field
trials
were
conducted
in
Region
13.
Current
guidelines
recommend
that
a
total
of
five
field
trials
be
conducted
in
Region
13
(
4
trials)
and
Region
3
(
1
trial).
Although
the
locations
differ
slightly,
the
data
support
a
permanent
tolerance
of
0.50
for
the
combined
residues
of
imidacloprid
and
its
metabolites
containing
the
6­
Page
17
of
30
chloropyridinil
moiety,
all
expressed
as
the
parent,
in/
on
banana.
A
revised
Section
F
should
be
submitted
to
include
the
HED­
recommended
tolerance.

PP#
5E6923
(
Herb,
Subgroup
19A):
The
crop
field
trial
data
for
basil
and
chives
are
classified
as
acceptable
and
satisfy
the
guideline
requirement
for
crop
field
trials
for
a
tolerance
on
herbs,
subgroup
19A
(
Residue
Chemistry
Guidelines
OPPTS
860.1500).
The
data
support
a
permanent
tolerance
of
8.0
ppm
for
the
combined
residues
of
imidacloprid
and
its
metabolites
containing
the
6­
chloropyridinil
moiety,
all
expressed
as
the
parent,
in/
on
herb,
subgroup
19A,
fresh.

The
treated
basil
sample
from
the
trial
that
produced
dried
basil
had
a
HAFT
value
of
1.17
ppm,
indicating
a
concentration
factor
of
11.8x
for
dried
basil.
As
this
value
exceeds
the
maximum
theoretical
concentration
factor
of
9x
for
dried
herbs
(
personal
communication
with
B.
Schneider,
5/
24/
06),
a
separate
tolerance
for
dried
herbs
is
needed.
Therefore,
using
the
HAFT
from
the
chives
trials
(
5.43
ppm)
and
the
9x
maximum
theoretical
concentration
factor,
the
data
support
a
permanent
tolerance
of
48
ppm
for
the
combined
residues
of
imidacloprid
and
its
metabolites
containing
the
6­
chloropyridinil
moiety,
all
expressed
as
the
parent,
in/
on
herb,
subgroup
19A,
dry.
A
revised
Section
F
should
be
submitted
to
include
the
recommended
tolerances
and
the
correct
commodity
definition
for
fresh
herbs.

6.6
Processed
Food
and
Feed:
As
there
are
no
processed
commodities
associated
with
caneberry,
sugar
apple
and
related
crops,
tree
nuts,
pomegranates,
and
bananas,
processing
studies
are
not
required
to
support
these
subject
petitions.
Sunflower
meal
oil
(
refined),
roasted
and
freeze­
dried
coffee,
and
dried
herbs
are
considered
processed
commodities.
See
Section
860.1500
for
detailed
information
on
dried
herbs.
The
results
of
the
processing
studies
indicate
that
separate
tolerances
on
processed
sunflower
seed
and
coffee
beans
are
not
needed.

6.7
Confined/
Field
Accumulation
in
Rotational
Crops:
No
rotational
crop
data
were
submitted
in
conjunction
with
the
proposed
uses.
According
to
the
current
guidance,
several
oilseed
crops
are
considered
to
be
rotated
crops.
The
following
rotational
crop
restrictions
are
currently
on
the
proposed
labels:

Commodity
Plantback
Interval
(
PBI)

Barley;
Broccoli;
Broccoli,
Chinese;
Broccoli
raab;
Brussels
Sprouts;
Cabbage,
Chinese
mustard;
Cabbage,
Chinese;
Cabbage;
Canola;
Cauliflower;
Collards;
Cotton;
Cucurbits;
Eggplant;
Ground
Cherry;
Kale;
Kohlrabi;
Lettuce;
Mustard
Greens;
Pepinos;
Pepper;
Potatoes;
Rape
greens;
Sorghum;
Sugarbeets;
Tomatillo;
Tomato;
Wheat
Immediate
Plantback
Cereals
(
including
buckwheat,
corn,
millet,
oats,
popcorn,
rice,
rye,
and
triticale);
Legume
(
including
soybeans,
beans
and
peas);
Safflower
30­
day
All
Other
Crops
12­
month
Adequate
canola
confined
rotational
crop
data
have
been
submitted
by
the
petitioner
and
reviewed
by
HED
in
conjunction
with
PP#
5F4534
(
Memo,
F.
Griffith,
9/
25/
95,
D216234).
Canola
can
be
rotated
immediately
following
the
harvest
of
crops
treated
with
imidacloprid.
Page
18
of
30
Therefore,
all
other
oilseed
crops
can
be
rotated
immediately
following
the
harvest
of
crops
treated
with
imidacloprid.
If
the
petitioner
chooses,
the
label
can
be
revised
to
include
oilseed
crops
in
the
list
of
commodities
with
no
plantback
restriction.

6.8
International
Considerations:
There
are
no
established
Mexican
maximum
residue
limits
(
MRLs)
for
the
proposed
uses.
There
are
established
Codex
MRLs
for
the
sum
of
imidacloprid
and
its
metabolites
containing
the
6­
chloropyridinyl
moiety,
expressed
as
imidacloprid,
in/
on
rapeseed
at
0.05
ppm
and
banana
at
0.05
ppm.
In
addition,
there
is
currently
Canadian
MRLs
for:
1­[(
6­
chloro­
3­
pyridinyl)
methyl]­
4,5­
dihydro­
N­
nitro­
1H­
imidazol­
2­
amine,
including
metabolites
containing
the
6­
chloropicolyl
moiety
in/
on
mustard,
seed
at
0.05
ppm,
rapeseed
(
canola)
at
0.05
ppm
and
pecans
at
0.05
ppm.
The
Codex
and
Canadian
MRLs
for
rapeseed
(
canola)
is
the
same
as
the
U.
S.­
recommended
tolerance
for
rapeseed,
seed;
and
the
Canadian
MRL
for
pecans
is
the
same
as
the
U.
S.­
recommended
tolerance.
However,
the
Canadian
MRL
for
banana
is
not
equivalent
to
the
U.
S.­
recommended
tolerance
as
the
available
crop
field
trial
data
supported
higher
tolerance
level.
Therefore,
harmonization
is
not
possible
at
this
time.

7.0
Drinking
Water
Considerations
Drinking
water
assessment
memo
­
DP#
311925,
R.
Parker,
5/
16/
06
In
a
meeting
on
12/
18/
02,
the
HED
Metabolism
Assessment
Review
Committee
(
MARC)
recommended
that
for
surface
water
risk
assessment,
degradates
of
concern
should
be
parent
and
the
three
degradates:
imidacloprid
urea,
imidacloprid
guanidine,
and
imidacloprid
olefin
(
Memo,
J.
Tyler
1/
13/
03;
D28740).
EFED
provided
revised,
Tier
1
estimated
drinking
water
concentrations
(
EDWCs)
for
surface
water
(
using
FIRST)
for
imidacloprid
and
its
degradates
(
imidacloprid
urea,
imidacloprid
guanidine,
and
imidacloprid
olefin)
for
the
proposed
uses
only.
Revised
ground
water
EDWCs
were
not
estimated
because
these
values
have
been
shown
previously
to
be
substantially
lower
in
magnitude
than
the
surface
water
concentrations.
The
revised
surface
water
EDWCs
for
the
proposed
uses
do
not
exceed
the
EDWCs
provided
by
EFED
in
conjunction
with
the
3/
14/
03
HED
risk
assessment
for
imidacloprid
(
Memo,
M.
Barrett,
2/
25/
03;
D271770).
Therefore,
the
overall
highest
surface
and
ground
water
EDWCs
were
used
in
the
current
risk
assessment.

Table
7.1
Estimated
Tier
1
Concentrations
of
Imidacloprid
in
Drinking
Water.
Surface
Water
(
µ
g/
L)
Groundwater
(
µ
g/
L)
Chemical
Acute
Chronic
Acute
and
Chronic
Revised
EDWCs1
Imidacloprid
total
residues2
Tree
nuts
 
35.9
Tree
nuts
and
coffee
 
15.3
Not
provided.
Previously­
calculated
EDWCs3
Imidacloprid
total
residues2
Citrus
 
36.0
Citrus
 
17.2
2.09
1.
Memo,
R.
Parker,
5/
16/
06;
DP#
311925.
2.
Imidacloprid
and
its
degradates
(
imidacloprid
urea,
imidacloprid
guanidine,
and
imidacloprid
olefin).
3.
Memo,
M.
Barrett,
2/
25/
03;
DP#
271770.
Page
19
of
30
8.0
Dietary
Risks
(
Food
and
Water)

Dietary
exposure
and
risk
assessment
­
DP#
322843,
J.
Tyler,
6/
15/
06
Imidacloprid
acute
and
chronic
dietary
exposure
assessments
were
conducted
using
the
Dietary
Exposure
Evaluation
Model
­
Food
Commodity
Intake
Database
 
(
DEEM­
FCID
 
;
ver.
2.03)
program
which
incorporates
consumption
data
from
the
United
Stated
Department
of
Agriculture's
(
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.
Consumption
data
are
averaged
for
the
entire
U.
S.
population
and
within
population
subgroups
for
chronic
exposure
assessment,
but
are
retained
as
individual
consumption
events
for
acute
exposure
assessment.

For
chronic
exposure
and
risk
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.

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
(
Tier
1
or
Tier
2)
exposure
assessment,
or
"
matched"
in
multiple
random
pairings
with
residue
values
and
then
summed
in
a
probabilistic
(
Tier
3/
4)
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.

HED's
level
of
concern
is
when
the
exposure
is
greater
than
100%
of
the
PAD.
That
is,
estimated
exposures
above
this
level
are
of
concern,
while
estimated
exposures
at
or
below
this
level
are
not
of
concern.
The
DEEM­
FCID
 
analysis
estimates
the
dietary
exposure
of
the
U.
S.
population
and
26
population
subgroups.
The
results
reported
in
Table
8.2.1
are
for
the
U.
S.
Population,
all
infants
(<
1
year
old),
children
1­
2
years
old,
children
3­
5
years
old,
children
6­
12
years
old,
youth
13­
19
years
old,
females
13­
49
years
old,
males
20­
49
years
old,
and
adults
50+
years
old.
Page
20
of
30
8.1
Acute
Dietary
Exposure
Estimates:
An
unrefined,
acute
dietary
exposure
assessment
[
using
tolerance­
level
residues
and
assuming
100%
crop
treated
(
CT)
for
all
registered
and
proposed
commodities]
was
conducted
for
the
general
U.
S.
population
and
various
population
subgroups.
Drinking
water
was
incorporated
directly
in
the
dietary
assessment
using
the
acute
(
peak)
concentration
for
surface
water
generated
by
the
FIRST
model.
This
assessment
concludes
that
the
acute
dietary
exposure
estimates
are
below
HED's
level
of
concern
[<
100%
acute
population
adjusted
dose
(
aPAD)]
at
the
95th
exposure
percentile
for
the
general
U.
S.
population
(
26%
of
the
aPAD)
and
all
other
population
subgroups.
The
most
highly
exposed
population
subgroup
is
children
1­
2
years
old,
at
67%
of
the
aPAD.
The
acute
assessment
was
highly
conservative,
using
several
upper­
end
assumptions.
Additional
refinements,
such
as
inclusion
of
anticipated
residues
(
ARs)
and
%
CT
data
could
be
made
in
order
to
refine
the
acute
assessment.

8.2
Chronic
Dietary
Exposure
Estimates:
A
partially
refined,
chronic
dietary
exposure
assessment
(
using
tolerance­
level
residues
for
all
registered
and
proposed
commodities,
and
%
CT
information
for
some
commodities)
was
conducted
for
the
general
U.
S.
population
and
various
population
subgroups.
Drinking
water
was
incorporated
directly
into
the
dietary
assessment
using
the
chronic
(
annual
average)
concentration
for
surface
water
generated
by
the
FIRST
model.
This
assessment
concludes
that
the
chronic
dietary
exposure
estimates
are
below
HED's
level
of
concern
(<
100%
cPAD)
for
the
general
U.
S.
population
(
11%
of
the
cPAD)
and
all
population
subgroups.
The
most
highly
exposed
population
subgroup
is
children
1­
2
years
old,
at
33%
of
the
cPAD.
The
chronic
assessment
was
conservative,
using
upper­
end
assumptions.
Additional
refinements,
such
as
inclusion
of
ARs
and
%
market­
share
data
for
the
proposed
uses
could
be
made
in
order
to
refine
the
chronic
assessment.

Table
8.2.1
Summary
of
Dietary
Exposure
and
Risk
for
Imidacloprid
Acute
Dietary1
(
95th
Percentile)
Chronic
Dietary2
Population
Subgroup
Dietary
Exposure
(
mg/
kg/
day)
%
aPAD
Dietary
Exposure
(
mg/
kg/
day)
%
cPAD
General
U.
S.
Population
0.036201
26
0.006172
11
All
Infants
(<
1
year
old)
0.076058
54
0.012681
22
Children
1­
2
years
old
0.093847
67
0.018738
33
Children
3­
5
years
old
0.068871
49
0.013361
23
Children
6­
12
years
old
0.042982
31
0.008000
14
Youth
13­
19
years
old
0.027765
20
0.004667
8.2
Adults
20­
49
years
old
0.024501
17
0.004814
8.4
Adults
50+
years
old
0.024450
17
0.005162
9.1
Females
13­
49
years
old
0.024571
18
0.004646
8.2
1.
Acute
dietary
endpoint
of
0.14
mg/
kg/
day
applies
to
the
general
U.
S.
population
and
all
population
subgroups.
2.
Chronic
dietary
endpoint
of
0.057
mg/
kg/
day
applies
to
the
general
U.
S.
population
and
all
population
subgroups.
Page
21
of
30
9.0
Aggregate
Risk
Aggregate
risk
assessments
were
performed
for
acute
(
food
+
drinking
water),
short­
term
aggregate
exposure
(
food
+
drinking
water
+
residential),
and
chronic
aggregate
exposure
(
food
+
drinking
water).
Intermediate­
and
long­
term
aggregate
risk
assessments
were
not
performed
because,
based
on
the
current
and
proposed
use
patterns,
HED
does
not
expect
residential
exposure
durations
that
would
result
in
intermediate­
or
long­
term
exposures1.
A
cancer
aggregate
risk
assessment
was
not
performed
because
imidacloprid
is
not
carcinogenic.
All
potential
exposure
pathways
were
assessed
in
the
aggregate
risk
assessment.

9.1
Acute
Aggregate
Risk
Assessment
(
Food
and
Drinking
Water):
The
acute
aggregate
risk
assessment
takes
into
account
exposure
estimates
from
dietary
consumption
of
imidacloprid
(
food
and
drinking
water).
The
dermal,
inhalation,
and
incidental
oral
exposures
resulting
from
short­
term
residential
applications
are
assessed
separately.
The
acute
dietary
exposure
estimates
are
below
HED's
level
of
concern
(<
100%
aPAD)
at
the
95th
exposure
percentile
for
the
general
U.
S.
population
(
26%
of
the
aPAD)
and
all
other
population
subgroups
(
see
Table
8.2.1).
The
most
highly­
exposed
population
subgroup
is
children
1­
2
years
old,
at
67%
of
the
aPAD.
Therefore,
the
acute
aggregate
risk
associated
with
the
proposed
use
of
imidacloprid
does
not
exceed
HED's
level
of
concern
for
the
general
U.
S.
population
or
any
population
subgroups.

9.2
Short­
term
Aggregate
Risk
Assessment
(
Food,
Residential
and
Drinking
Water):
The
short­
term
aggregate
risk
assessment
estimates
risks
likely
to
result
from
1­
to
30­
day
exposure
to
imidacloprid
residues
from
food,
drinking
water,
and
residential
pesticide
uses.
High­
end
estimates
of
the
residential
exposure
are
used
in
the
short­
term
assessment,
and
average
values
are
used
for
food
and
drinking
water
exposures.

Short­
term
aggregate
risk
assessments
are
required
for
adults
as
there
is
potential
for
both
dermal
and
inhalation
handler
exposure,
and
dermal
post­
application
exposure
from
the
residential
uses
of
imidacloprid
on
turf
and
pets.
In
addition,
short­
term
aggregate
risk
assessments
are
required
for
children/
toddlers
because
there
is
a
potential
for
oral
and
dermal
post­
application
exposure
resulting
from
the
residential
uses
of
imidacloprid
on
turf
and
pets.
The
short­
term
residential
exposure
potential
from
the
turf
and
pet
uses
for
adults
and
children/
toddlers
can
be
found
in
Table
11
of
HED's
most
recent
human
health
risk
assessment
(
Memo,
J.
Tyler,
et
al.
3/
4/
03;
D286101).
The
pet­
treatment
scenario
resulted
in
the
lowest
combined
MOE
for
adults
(
MOE
=
400;
handler
and
post­
application)
and
children
(
MOE
=
260;
post­
application).
The
turftreatment
resulted
in
much
lower
exposures
for
both
adults
(
MOE
=
15,000;
handler
and
postapplication
and
children
(
MOE
=
1,500;
post­
application).
Therefore,
the
pet­
treatment
exposure
estimates
were
aggregated
with
the
chronic
dietary
(
food)
to
provide
a
worst­
case
estimate
of
short­
term
aggregate
risk
for
the
U.
S.
population
and
children
1­
2
years
old
(
the
child
population
subgroup
with
the
highest
estimated
chronic
dietary
food
exposure)
(
see
Table
8.2.1).

1
It
should
be
noted
that
imidacloprid
is
registered
as
a
pre­
and
post­
construction
termiticide.
However,
due
to
the
low
volatility
and
short
half­
life
of
imidacloprid,
coupled
with
the
fact
that
it
is
used
pre­
and
post­
construction
only,
HED
does
not
expect
there
to
be
potential
for
long­
term
exposure
to
imidacloprid
from
this
use.
Page
22
of
30
As
the
MOEs
are
greater
than
100,
the
short­
term
aggregate
risks
are
below
HED's
level
of
concern.

Table
9.2.1
Short­
Term
Aggregate
Risk
Calculations
for
Imidacloprid.

Short­
Term
Scenario
Population
Subgroups
NOAEL
(
mg/
kg/
day)
Level
of
Concern1
Max
Exposure2
(
mg/
kg/
day)
Average
Dietary
Exposure
(
mg/
kg/
day)
Residential
Exposure3
(
mg/
kg/
day)
Aggregate
MOE
(
dietary
and
residential)
4
U.
S.
Population
10
100
0.1
0.006172
0.025
320
Children
1­
2
years
old
10
100
0.1
0.018738
0.03876
170
1
The
level
of
concern
(
target
MOE)
includes
10X
for
interspecies
extrapolation
and
10X
for
intraspecies
variation.
2
Maximum
Exposure
(
mg/
kg/
day)
=
NOAEL/
Target
MOE
3
Residential
Exposure
=
[
Oral
exposure
+
Dermal
exposure
+
Inhalation
Exposure].
The
pet­
treatment
scenario
resulted
in
the
lowest
combined
residential
MOE
for
adults
(
handler
and
post­
application)
and
children
(
post­
application).
The
combined
MOEs
for
the
pet­
use
scenario
were
used
to
calculate
the
short­
term
risk
[
see
Table
11
of
HED
human
health
risk
assessment
dated
3/
4/
03
(
Memo,
J.
Tyler
et
al.;
D286101)].
4
Aggregate
MOE
=
[
NOAEL
÷
(
Avg
Dietary
Exposure
+
Residential
Exposure)]

9.3
Chronic
Aggregate
Risk
Assessment
(
Food
and
Drinking
Water):
The
chronic
aggregate
risk
assessment
takes
into
account
average
exposure
estimates
from
dietary
consumption
of
imidacloprid
(
food
and
drinking
water)
and
residential
uses.
However,
due
to
the
use
patterns,
no
chronic
residential
exposures
are
expected.
Therefore,
the
chronic
aggregate
risk
assessment
will
consider
exposure
from
food
and
drinking
water
only.
The
chronic
dietary
exposure
estimates
are
below
HED's
level
of
concern
(<
100%
cPAD)
for
the
general
U.
S.
population
(
11%
of
the
cPAD)
and
all
population
subgroups
(
see
Table
8.2.1).
The
most
highly
exposed
population
subgroup
is
children
1­
2
years
old,
at
33%
of
the
cPAD.
Therefore,
the
chronic
aggregate
risk
associated
with
the
proposed
use
of
imidacloprid
does
not
exceed
HED's
level
of
concern
for
the
general
U.
S.
population
or
any
population
subgroups.

10.0
Cumulative
Unlike
other
pesticides
for
which
EPA
has
followed
a
cumulative
risk
approach
based
on
a
common
mechanism
of
toxicity,
EPA
has
not
made
a
common
mechanism
of
toxicity
finding
for
imidacloprid
and
any
other
substances;
and
imidacloprid
does
not
appear
to
produce
a
toxic
metabolite
produced
by
other
substances.
For
the
purposes
of
this
tolerance
action,
therefore,
EPA
has
assumed
that
imidacloprid
does
not
have
a
common
mechanism
of
toxicity
with
other
substances.
For
information
regarding
EPA's
efforts
to
determine
which
chemicals
have
a
common
mechanism
of
toxicity
and
to
evaluate
the
cumulative
effects
of
such
chemicals,
see
the
policy
statements
released
by
EPA's
Office
of
Pesticide
Programs
concerning
common
mechanism
determinations
and
procedures
for
cumulating
effects
from
substances
found
to
have
a
common
mechanism
on
EPA's
website
at
http://
www.
epa.
gov/
pesticides/
cumulative/.
Page
23
of
30
11.0
Occupational
Exposure
Occupational
exposure
and
risk
assessment
­
DP#
328188,
M.
Dow,
6/
15/
06
See
Attachment
1
for
a
summary
of
the
proposed
uses.

11.1
Occupational
Handler
Exposure
and
Risk:
Based
on
the
proposed
new
use
patterns,
commercial
and
private
(
i.
e.,
grower
operators)
pesticide
handlers
are
typically
expected
to
have
short­
term
exposures
(
i.
e.,
1­
30
days).
The
acreages
involved
with
the
crops
in
this
assessment
are
relatively
small
as
compared
to
such
field
crops
as
cotton,
corn
or
soybean.
However,
the
HED
Science
Advisory
Council
for
Exposure
(
ExpoSAC)
asserts
that
there
is
a
possibility
that
commercial
handlers
might
be
exposed
to
intermediate­
term
exposures
(
1­
6
months).

The
proposed
use
patterns
indicate
that
the
most
highly­
exposed
occupational
pesticide
handlers
are
likely
to
be
mixer/
loaders
using
open­
pour
loading
of
liquids
or
granules,
and
applicators
using
airblast
sprayers,
high­
pressure
hand­
wand
sprayers,
backpack
sprayers
and
aircraft.
Chemigation
in
the
form
of
drip
or
low­
pressure
trickle
irrigation
are
also
mentioned
as
methods
of
application.

HED
believes
that
a
"
loader"
(
i.
e.,
applicator
in
this
sense)
for
chemigation
will
not
likely
be
exposed
more
than
a
loader
supporting
aerial
operations.
Chemigation
typically
involves
preparation
of
mini­
bulk
containers
that
have
siphon
tubes
attached
to
the
irrigation
equipment.
An
individual
preparing
irrigation
equipment
to
include
pesticide
application
is
believed
to
experience
exposure
similar
to
that
of
a
mixer/
loader
using
open­
pour
loading
technique.
Therefore,
a
"
Chemigator"
is
not
assessed,
with
the
assumption
that
the
work
activity
is
represented
by
that
of
a
mixer/
loader
supporting
aerial
operations.
Chemigation
includes
the
soil
injection
and
drip
irrigation
methods
of
application
used
for
caneberries.

In
some
cases,
HED
believes
that
certain
individuals
(
private
growers
versus
commercial
applicators)
may
perform
all
three
handler
activities,
that
is,
mix,
load,
and
apply
the
material.
The
available
exposure
data
for
combined
mixer/
loader/
applicator
scenarios
are
limited
in
comparison
to
the
monitoring
of
these
two
activities
separately.
These
exposure
scenarios
are
outlined
in
the
Pesticide
Handler
Exposure
Database
(
PHED)
Surrogate
Exposure
Guide
(
August
1998).
HED
has
adopted
a
methodology
to
present
the
exposure
and
risk
estimates
separately
for
the
job
functions
in
some
scenarios
and
to
present
them
as
combined
in
other
cases.
Most
exposure
scenarios
for
hand­
held
equipment
(
such
as
hand
wands,
backpack
sprayers,
and
pushtype
granular
spreaders)
are
assessed
as
a
combined
job
function.
With
these
types
of
hand
held
operations,
all
handling
activities
are
assumed
to
be
conducted
by
the
same
individual.
The
available
monitoring
data
support
this
and
HED
presents
them
in
this
way.
Conversely,
for
equipment
types
such
as
fixed­
wing
aircraft,
ground­
boom
tractors,
or
air­
blast
sprayers,
the
applicator
exposures
are
assessed
and
presented
separately
from
those
of
the
mixers
and
loaders.
By
separating
the
two
job
functions,
HED
determines
the
most
appropriate
levels
of
personal
protective
equipment
(
PPE)
for
each
aspect
of
the
job
without
requiring
an
applicator
to
wear
unnecessary
PPE
that
may
be
required
for
a
mixer/
loader
(
e.
g.,
chemical­
resistant
gloves
may
only
be
necessary
during
the
pouring
of
a
liquid
formulation).
Page
24
of
30
No
chemical­
specific
data
are
available
with
which
to
assess
potential
exposure
to
pesticide
handlers.
The
estimates
of
exposure
to
pesticide
handlers
are
based
upon
surrogate
study
data
available
in
the
PHED
(
v.
1.1,
1998).
For
pesticide
handlers,
it
is
HED
policy
to
present
estimates
of
dermal
exposure
for
"
baseline"
that
is,
with
a
single
layer
of
work
clothing
consisting
of
a
long­
sleeved
shirt,
long
pants,
shoes
plus
socks
and
no
protective
gloves
and
for
"
baseline"
and
the
use
of
protective
gloves
or
other
PPE
as
might
be
necessary.
See
Table
11.1
for
estimated
exposure
and
risk
to
"
occupational
pesticide
handlers.

Table
11.1
Estimated
Handler
Exposure
and
Risk
from
the
Use
of
Imidacloprid.

Combined
MOE5
Unit
Exposure1
(
mg
ai/
lb
handled)
Application
Rate2
(
lb
ai/
A)
Units
Treated3
Per
Day
(
A)
ADD4
(
mg
ai/
kg
bw/
day)
Short­
term
Intermediateterm
Mixer/
Loader
­
Liquid
­
Open
Pour
­

Dermal:
SLNG
2.9
HC
SLWG
0.023
HC
Inhal
0.0012
HC
0.5
350
Dermal:
No
Gloves
0.51
With
Gloves
0.004
Inhal
0.003
NG
20
WG
1400
NG
18
WG
1300
Mixer/
Loader
­
Open
Pour
­
Granules
(
banana
&
plantain)

Dermal:
SLNG
0.0084
LC
SLWG
0.0069
MC
Inhal
0.0017
HC
0.1
350
Dermal:
No
Gloves
0.00029
With
Gloves
0.00024
Inhal
0.00085
NG
8800
WG
9200
NG
8200
WG
8500
Applicator
­
Aerial
(
Pilots
not
required
to
wear
protective
gloves)

Dermal:
SLNG
0.0050
HC
Inhal
0.000068
MC
0.5
350
Dermal:
No
Gloves
0.00088
Inhal
0.00017
NG
9500
NG
8900
Applicator
­
Air­
blast
­
Open
Cab
Dermal:
SLNG
0.36
HC
SLWG
0.24
HC
Inhal
0.0045
HC
0.5
40
Dermal:
No
Gloves
0.0072
With
Gloves
0.0048
Inhal
0.0013
NG
1200
WG
1600
NG
1100
WG
1500
Mix/
Load/
Applicator
­
High
Pressure
Hand­
wand
Dermal
SLNG
no
data
SLWG
2.5
LC
Inhal
0.12
LC
0.5
20
Dermal:
No
Gloves
no
data
Wit
Gloves
0.025
Inhal
0.017
NG
no
data
WG
240
NG
no
data
WG
220
Mixer/
Loader/
Applicator
­
Backpack
­
Liquid
­
Open
Pour
Dermal:
SLNG
no
data
SLWG
2.5
LC
Inhal
0.03
LC
0.5
1
Dermal:
No
Gloves
­
no
data
With
Gloves
0.0013
Inhal
0.00021
NG
no
data
WG
6600
NG
no
data
WG
6200
1.
Unit
Exposures
are
taken
from
"
PHED
SURROGATE
EXPOSURE
GUIDE,"
Estimates
of
Worker
Exposure
from
The
Pesticide
Handler
Exposure
Database
Version
1.1,
August
1998.
SLNG
=
Dermal
Single
Layer
Work
Clothing
No
Gloves;
SLWG
=
Dermal
Single
Layer
Work
Page
25
of
30
Clothing
With
Gloves;
Inhal.
=
Inhalation.
Units
=
mg
ai/
pound
of
active
ingredient
handled.
Data
Confidence:
LC
=
Low
Confidence,
MC
=
Medium
Confidence,
HC
=
High
Confidence.
2.
Applic.
Rate.
=
Taken
from
Sections
A
&
B
(
proposed
labeling)
of
IR­
4
submission
for
each
crop.
3.
Units
Treated
are
taken
from
"
Standard
Values
for
Daily
Acres
Treated
in
Agriculture";
SOP
No.
9.1.
Science
Advisory
Council
for
Exposure;
Revised
5
July
2000;
Policy
9.1
indicates
a
worker
may
spray
40
gallons/
day
with
a
backpack
sprayer.
The
labeling
for
tree
nuts
indicates
50
gal/
A
by
ground
equipment.
Therefore
a
backpack
sprayer
might
treat
1
acre.
A
high­
pressure
hand­
wand
can
spray
1,000
gal/
day.
At
50
gal/
A
=
20
A/
day
for
high­
pressure
hand­
wand.
4.
Average
Daily
Dose
=
Unit
Exposure
*
Applic.
Rate
*
Units
Treated
*
0.07
(
7
%
dermal
absorption)
÷
Body
Weight
(
70
kg).
5.
MOE
=
Margin
of
Exposure
=
No
Observable
Adverse
Effect
Level
(
NOAEL)
÷
ADD.
Short­
term
dermal
and
inhalation
NOAEL
=
10
mg
ai/
kg
bw/
day
and
are
identified
from
developmental
study
in
the
rat
where
maternal
effects
(
9body
weight
gain)
were
observed.
MOEs
are
"
combined"
that
is,
Dermal
+
Inhalation,
since
the
toxicological
effects
are
the
same
and
are
identified
from
the
same
study.
Intermediate­
term
NOAEL
=
9.3
mg
ai/
kg
bw/
day.
ST
=
Short­
term
combined
MOE;
IT
=
Intermediate­
term
combined
MOE.
NG
=
No
gloves.
WG
=
With
gloves.

A
MOE
of
100
is
adequate
to
protect
occupational
pesticide
handlers.
All
MOEs
are
>
100
provided
mixer/
loaders
where
protective
gloves
as
specified
on
the
labels.

11.2
Exposures
and
Risks
from
Commercial
Seed
Treatment:
Estimated
exposures
and
risks
to
individuals
involved
in
commercial­
scale
seed
treatment
operations
are
presented
in
HED's
occupational
exposure
assessment
memo
(
see
pages
9­
12).
The
seed
treatment
exposure
and
risk
calculator
indicate
that
a
"
loader/
applicator"
has
a
MOE
of
59
if
he
or
she
is
using
a
single
layer
of
work
clothing
and
NO
gloves
and
a
MOE
of
77
WHEN
gloves
are
worn.
MOEs
less
than
100
exceed
HED's
level
of
concern.
Since
exposure
is
believed
to
be
directly
related
to
the
amount
of
active
ingredient
handled
per
day,
a
loader/
applicator
would
have
a
MOE
greater
than
100
if
half
the
amount
of
active
ingredient
is
handled
per
day.

In
addition
to
mixer/
loaders,
individuals
involved
in
"
multiple
activities"
which
includes
sweeping
the
floors
and
several
other
variable
activities
during
the
day,
have
a
MOE
of
33,
which
exceeds
HED's
level
of
concern.
HED
believes
that
only
engineering
controls
such
as
greater
air
filtration
or
reduction
of
dustiness
during
the
seed
treatment
and
handling
processes
can
reduce
exposures
to
such
individuals.
HED
must
rely
on
industry
suggestions
or
methods
to
derive
economic
and
practical
methods
to
reduce
exposures.

The
calculated
MOEs
are
based
upon
the
most
conservative
assumptions
in
terms
of
the
high
rate
of
application
and
the
maximum
possible
amount
of
seed
treated
per
day.
These
estimates
are
based
upon
a
daily
seed
treatment
production
of
718,000
lb
of
seed
per
day.
While
it
is
possible
for
the
machinery
to
process
that
amount
of
seed,
in
the
practical
sense
HED
believes
it
is
not
probable.

The
"
Crop
Profile
for
Safflower
Production
in
South
Dakota"
(
www.
ipmcenters.
org)
lists
the
primary
safflower
producing
states
(
CA,
MO,
UT,
SD,
ND,
ID,
AZ,
CO).
Total
amount
of
safflower
planted
in
these
states
is
194,545
acres.
Planting
rates
(
i.
e.,
seeding
rates)
for
safflower
varies
from
20
lb
seed
per
acre
to
100
lb
seed
per
acre.
If
it
is
assumed
that
all
acres
were
planted
at
the
maximum
rate
(
i.
e.,
100
lb
seed/
A),
then
19,454,500
lb
of
seed
would
be
required
on
a
national
basis.
At
a
seed
treatment
production
rate
of
718,000
lb
of
seed
per
day,
it
would
take
27
days.
It
is
highly
unlikely
that
all
acres
are
planted
at
the
maximum
seeding
rate.
Planting
within
the
various
states
and
among
the
various
producing
states,
will
not
occur
simultaneously.
The
planting
"
window"
is
30
to
40
days
across
the
producing
states.
Treatment
of
seed
will
not
occur
all
at
one
time
or
all
at
one
treatment
facility.
Therefore,
HED
believes
it
Page
26
of
30
is
highly
unlikely
that
seed
would
be
treated
at
the
maximum
rate
of
718,000
lb
per
day.
HED
suggests
that
although
the
MOEs
listed
are
theoretically
possible,
they
are
not
probable
and
that
the
true
exposure
and
risk
are
much
less
than
what
has
been
conservatively
calculated.

11.3
Occupational
Post­
Application
Exposure:
Typically,
there
is
the
possibility
for
agricultural
workers
to
experience
post­
application
exposures
to
dislodgeable
pesticide
residues.
There
are
no
chemical­
specific
data
with
which
to
estimate
post­
application
exposure
of
agricultural
workers
to
dislodgeable
residues
of
imidacloprid.
Therefore,
theoretical
estimates
of
exposure,
based
on
surrogate
studies,
have
been
conducted.
The
ExpoSAC
(
SOP
003.1,
Rev.
7
Aug.
2000,
Regarding
Agricultural
Transfer
Coefficients;
Amended
ExpoSAC
Meeting
notes
­
13
Sept
01)
lists
a
number
of
possible
post­
application
agricultural
activities
relative
to
some
of
the
subject
crops
that
might
result
in
pesticide
exposure
to
agricultural
workers.
Transfer
Coefficients
(
TCs)
expressed
as
cm
²
/
hr
are
identified
for
each
of
the
post­
application,
agricultural
activities.
The
TCs
are
derived
from
data
in
surrogate
exposure
studies
conducted
during
the
various
activities
listed.

The
highest
(
i.
e.,
most
conservative)
TCs
relative
to
the
subject
crops
appear
to
be
for
activities
related
to
pomegranate.
The
activities
are
hand
harvesting
and
irrigation
activities
with
TCs
of
3,000
cm
²
/
hr
and
1,000
cm
²
/
hr
respectively.
Hand
harvesting
of
tree
nuts
and
hand
pruning
of
tree
nuts
have
associated
TC
of
2,500
cm
²
/
hr.
For
risk
assessment
purposes,
a
TC
of
3,000
cm
²
/
hr
is
used
in
conjunction
with
the
maximum
rate
of
application
of
0.5
lb
ai/
A.

The
TCs
used
in
this
assessment
are
from
an
interim
transfer
coefficient
SOP
developed
by
HED's
ExpoSAC
using
proprietary
data
from
the
Agricultural
Re­
Entry
Task
Force
(
ARTF)
database
(
policy
#
3.1).
It
is
the
intention
of
the
ExpoSAC
that
this
SOP
will
be
periodically
updated
to
incorporate
additional
information
about
agricultural
practices
in
crops
and
new
data
on
transfer
coefficients.
Much
of
this
information
will
originate
from
exposure
studies
currently
being
conducted
by
the
ARTF,
from
further
analysis
of
studies
already
submitted
to
the
Agency,
and
from
studies
in
the
published
scientific
literature.

Post­
application
worker
exposure
is
estimated
using
HED
procedure
that
assumes
20%
of
the
application
rate
is
available
as
dislodgeable
foliar
residue
on
the
day
of
treatment.
HED
does
not
expect
post­
application
exposures
to
exceed
short­
term
exposure.
Therefore,
only
short­
term
exposures
are
assessed.
However,
the
HED
ExpoSAC
directs
that
there
may
be
intermediateterm
exposures
(
1
­
6
months)
to
agricultural
workers.
The
following
convention
is
used
to
estimate
post­
application
exposures
to
agricultural
workers.

PDRt
=
DFRt
*
CF1
*
Tc
*
ET
where:
PDRt
=
potential
dose
rate
on
day
"
t"
(
mg/
day)
DFRt
=
dislodgeable
foliar
residue
on
day
"
t"
(
Fg/
cm2)
CF1
=
weight
unit
conversion
factor
to
convert
Fg
units
in
DFR
value
to
mg
for
the
daily
dose
(
0.001
mg/
Fg)
Tc
=
transfer
coefficient
(
cm2/
hr)
(
In
this
case
3,000
cm2/
hr;
ExpoSAC
Policy
003.1
Rev.
7
Aug.
2000;
amended
13
Sept
01
ExpoSAC
meeting
Notes).
ET
=
Exposure
Time
(
hrs)
(
8)
Page
27
of
30
and
DFRt
=
AR
*
F
*
(
1­
D)
t
*
CF2
*
CF3
where:

AR
=
Application
rate
(
lb
ai/
A)
(
0.5
lb
ai/
A)
F
=
fraction
of
ai
on
foliage
available
as
dislodgeable
residue
(
unitless)(
20.0
%)
D
=
fraction
of
residue
that
dissipates
daily
(
unitless)
(
10.0
%)
t
=
postapplication
day
on
which
exposure
is
being
assessed
CF2
=
weight
unit
conversion
factor
to
convert
the
lbs
ai
in
the
application
rate
to
Fg
for
the
DFR
value
(
4.54E8
Fg/
lb)
CF3
=
Area
unit
conversion
factor
to
convert
the
surface
area
units
(
ft2)
in
the
application
rate
to
cm2
for
the
DFR
value
(
1.08E­
3
ft2/
cm2
or
2.47E­
8
acre/
cm2
if
the
application
rate
is
per
acre).

 
DFR
=
0.5
lb
ai/
A
*
0.20
*
(
1­
0)
0
*
4.54E8
Fg
ai/
lb
*
2.47E­
8A/
cm2
=
1.121
Fg/
cm2
PDR
=
1.121
Fg/
cm2
*
0.001
mg/
Fg
*
3,000
cm2/
hr
*
8
hr/
day
=
26.9
mg
ai/
day
*
0.07
(%
dermal
absorption)
÷
70
kg
bw
=
0.0269
mg
ai/
kg
bw/
day
Margin
of
Exposure
(
MOE)
=
NOAEL
÷
PDR
 
10
mg
ai/
kg
bw/
day
÷
0.0269
mg
ai/
kg
bw/
day
=
371
=
Short
Term
MOE
and
9.3
mg
ai/
kg
bw/
day
÷
0.0269
mg
ai/
kg
bw/
day
=
345
=
Intermediate
Term
MOE.

These
estimates
are
considered
to
be
screening­
level
estimates
(
i.
e.,
conservative
and
protective).
HED's
level
of
concern
for
dermal
exposure
is
for
MOEs
<
100.
In
this
case,
MOEs
are
greater
than
100;
therefore,
post­
application
dermal
exposure
is
not
of
concern
for
agricultural
workers.
Post­
application
inhalation
exposure
is
expected
to
be
negligible.

11.4
Restricted
Entry
Interval
(
REI):
Imidacloprid
is
classified
in
Toxicity
Category
IV
for
acute
dermal,
acute
inhalation,
primary
eye
irritation
and
primary
skin
irritation;
therefore,
the
interim
Worker
Protection
Standard
REI
of
12
hours
is
sufficient
to
protect
workers
from
excessive
exposure.

11.5
Incidents:
According
to
OPPs
Incident
Data
System
there
are
a
number
of
unconfirmed
incidents
regarding
imidacloprid.
The
State
of
California
sent
a
report
in
1999
of
56
cases
involving
imidacloprid
the
majority
of
which
involved
pesticide
mixtures.
In
only
one
case
was
imidacloprid
considered
the
cause
of
the
illness
(
a
kennel
worker
splashed
a
drop
in
his
eye
which
began
burning
and
had
a
corneal
abrasion)
[
Personal
Communication
from
Dr.
Jerome
Blondell
(
e­
mail
10/
31/
02)].
Page
28
of
30
12.0
Data
Needs
and
Label
Requirements
12.1
Toxicology
 
None.

12.2
Residue
Chemistry
PP#
3E6543
(
Caneberry,
Subgroup
13A):
 
Additional
crop
field
trial
data
on
either
blackberry
or
raspberry
from
Region
1
(
1
trial),
Region
5
(
1
trial)
and
Region
10
(
1
trial).

PP#
3E6561
(
Coffee):
 
Revised
Section
F
to
include
the
HED­
recommended
tolerance.

PP#
3E6760
(
Sugar
Apple
and
Related
Crops):
 
Revised
Section
F
to
include
the
HED­
recommended
tolerances.

PP#
5E6920
(
Tree
Nuts,
Including
Pistachios):
 
Revised
Provado
®
1.6F
label
to
clarify
the
maximum
single
application
rate.
 
Revised
Admire
®
2F
label
to
specify
a
maximum
total
application
rate
of
0.35
lb
ai/
A.
 
Revised
Section
F
to
include
the
HED­
recommended
tolerances.

PP#
5E6921
(
Pomegranate):
 
Revised
Admire
®
2F
label
should
be
revised
to
specify
a
7­
day
PHI.
 
Revised
Section
F
to
include
the
HED­
recommended
tolerance.

PP#
5E6922
(
Banana):
 
Revised
Section
F
to
include
the
HED­
recommended
tolerance.

PP#
5E6923
(
Herbs,
Subgroup
19A):
 
Revised
Section
F
to
include
the
HED­
recommended
tolerances.

11.3
Occupational
and
Residential
Exposure
 
None.

12.0
Attachments
Attachment
1:
Proposed
Use
Pattern.

cc:
J.
Tyler
(
RAB1)
RDI:
RAB1
Branch
(
6/
7/
06),
PV
Shah
(
6/
15/
06)
J.
Tyler:
S­
10943:(
703)
305­
5564:
7509C:
RAB1
Page
29
of
30
Attachment
1.
Proposed
Use
Pattern.

Application
Rate
(
lb
ai/
A)
PP#
Crop
Product
(
EPA
Reg.
No.)
#
App.
Per
app.
Per
season
RTI
(
days)
PHI
(
days)
REI
(
hours)
Restrictions
3E6543
Caneberry,
Subgroup
13A1
Admire
®
2F
1
0.5
0.5
na
7
12
Soil
injection
or
a
drip
irrigation
system
in
2500­
5000
gallons
of
water
per
acre.

3E6561
Coffee
Provado
®
1.6F
5
0.1
0.5
7
7
12
­

Gaucho
®
480
Flowable
1
1.0
lb
ai/
cwt
1.0
lb
ai/
cwt
na
na
na
3E6738
Sunflower
and
oilseed
crops2
Gaucho
®
600
Flowable
1
1.0
lb
ai/
cwt
1.0
lb
ai/
cwt
na
na
na
Rape
greens
grown
and
harvested
from
Gaucho
480
and
600
treated
seed
must
not
be
used
for
human
and
feed
consumption.

Rapeseed,
specifically
noncanola
varieties,
grown
and
harvested
from
Gaucho
40
and
600
treated
seed
is
only
for
industrial
uses
and
cannot
be
used
for
edible
oil
or
any
other
human/
feed
consumption.
3E6760
Sugar
apple
and
related
crops3
Provado
®
1.6F
0.1
0.5
7
14
12
Minimum
of
40
gallons
per
acre.

Provado
®
1.6F
2
0.0875
(
label
reads
0.1)
0.36
6
7
12
Ground
or
aerial
applications;
minimum
50
GPA
for
ground
and
25
GPA
for
aerial.

Do
not
apply
pre­
bloom
or
during
bloom
or
when
bees
are
actively
foraging.

Not
permitted
in
California
unless
otherwise
directed
by
supplemental
labeling.
5E6920
Tree
Nuts,
including
pistachios
Admire
®
2F
Ns
0.5
0.50
ns
7
12
Do
not
apply
pre­
bloom
or
during
bloom
or
when
bees
are
actively
foraging.

Chemigation
into
the
root­
zone
through
low­
pressure
drip,
trickle,
micro­
sprinkler
or
equivalent
equipment.
Emitter
or
spot
applications
in
a
minimum
of
4
fl
oz
of
mixture
per
emitter
site.
Subsurface
side­
dress,
shanked
into
the
root
zone
near
emitter
line.
Treat
distance
wetted
by
the
emitter
set
of
each
tree.

Not
permitted
in
California
unless
otherwise
directed
by
supplemental
labeling.

5E6921
Pomegranate
Admire
®
2F
1
0.5
0.5
na
0
12
Do
not
apply
pre­
bloom
or
during
bloom
or
when
bees
are
actively
foraging.

Chemigation
into
the
root­
zone
Page
30
of
30
Application
Rate
(
lb
ai/
A)
PP#
Crop
Product
(
EPA
Reg.
No.)
#
App.
Per
app.
Per
season
RTI
(
days)
PHI
(
days)
REI
(
hours)
Restrictions
Provado
®
1.6F
3
0.1
0.3
7
7
12
through
low­
pressure
drip,
trickle,
micro­
sprinkler
or
equivalent
equipment.

Not
permitted
in
California
unless
otherwise
directed
by
supplemental
labeling.

Provado
®
1.6F
5
0.10
0.50
14
0
12
Provado
®
75%
WP
Ns
0.10
0.50
14
0
12
Provado
®
70
WG
ns
0.10
0.50
14
0
12
Ground
or
aerial
applications.

Not
permitted
in
California
unless
otherwise
directed
by
supplemental
labeling.

Gaucho
®
550
SC
ns
0.25­
0.50
0.50
ns
0
12
Gaucho
®
600
SC
ns
0.25­
0.50
0.50
ns
0
12
5E6922
Banana
Admire
®
2F
ns
0.25­
0.50
0.50
ns
0
12
Chemigation
into
the
root­
zone
through
low­
pressure
drip,
trickle,
micro­
sprinkler
or
equivalent
equipment.

Not
permitted
in
California
unless
otherwise
directed
by
supplemental
labeling.

Admire
®
2
1
0.375
0.375
na
na
12
Apply
in
furrow
at
planting.
5E6923
Herbs4
Provado
®
1.6F
3
0.044
0.132
5
7
12
Apply
in
a
minimum
of
30
gallons
per
acre.
