Document ID: EPA-HQ-OPP-2006-0366-0002
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2006-07-11T04:00Z

EPA
Registration
Division
contact:
Barbara
Madden
(
703)
305­
6463
Interregional
Research
Project
#
4
(
IR­
4)
and
FMC
Corporation
PP#
s
2E6423,
2E6451,
2E6492,
3E6882,
4E6843
EPA
has
received
pesticide
petitions
(
PP
No.:
2E6423,
2E6451,
2E6492,
3E6882,
4E6843)
from
IR­
4,
The
Technology
Centre
of
New
Jersey,
681
US
Hwy
#
1,
South,
North
Brunswick,
NJ
08902­
3390
and
prepared
by
the
registrant,
FMC
Corporation,
1735
Market
Street,
Philadelphia,
PA
19103
proposing,
pursuant
to
section
408(
d)
of
the
Federal
Food,
Drug,
and
Cosmetic
Act
(
FFDCA),
21
U.
S.
C.
346a(
d),
to
amend
40
CFR
part
180.442
by
establishing
a
tolerance
for
residues
of
bifenthrin
((
2­
methyl
1,1
­
biphenyl­
3­
yl)
methyl­
3­(
2­
chloro­
3,3,3,­
trifluoro­
1­
propenyl)­
2,2­
dimethylcyclopropanecarboxylate
in
or
on
the
raw
agricultural
commodities
leafy
brassica
greens,
subgroup
5B
and
turnip,
tops
at
3.0
parts
per
million
(
ppm)
(
2E6451),
tuberous
and
corm
vegetables,
subgroup
1C
at
0.1
ppm
(
3E6882),
Okra
at
0.5
ppm
(
2E6492),
dried
shelled
pea
and
bean
(
except
soybean),
subgroup
6C
at
0.1
ppm
(
2E6423),
Cilantro
at
5.0
ppm
(
4E6843).
EPA
has
determined
that
the
petition
contains
data
or
information
regarding
the
elements
set
forth
in
section
408(
d)(
2)
of
the
FFDCA;
however,
EPA
has
not
fully
evaluated
the
sufficiency
of
the
submitted
data
at
this
time
or
whether
the
data
supports
granting
of
the
petition.
Additional
data
may
be
needed
before
EPA
rules
on
the
petition.

A.
Residue
Chemistry
1.
Plant
metabolism.
The
metabolism
of
bifenthrin
in
plants
is
adequately
understood.
Studies
have
been
conducted
to
delineate
the
metabolism
of
radiolabelled
bifenthrin
in
various
crops
all
showing
similar
results.
The
residue
of
concern
is
the
parent
compound
only.

2.
Analytical
method.[
There
is
a
practical
analytical
method
for
detecting
and
measuring
levels
of
bifenthrin
in
or
on
food
with
a
limit
of
detection
that
allows
monitoring
of
food
with
residues
at
or
above
the
levels
set
in
these
tolerances
Gas
Chromatography
with
Electron
Capture
Detection
(
GC/
ECD).

3.
Magnitude
of
residues.
Field
residue
trials
meeting
EPA
study
requirements
have
been
conducted
at
the
maximum
label
rate
for
the
crops
leafy
brassica
greens,
tuberous
and
corm
vegetables,
okra,
cilantro
and
dried
shelled
pea
and
bean.
Results
from
the
studies
demonstrate
that
the
highest
bifenthrin
residues
found
will
not
exceed
the
proposed
tolerances
for
leafy
brassica
greens,
subgroup
5B
and
turnip
tops
at
3.0
parts
per
million
(
ppm),
tuberous
and
corm
vegetables,
subgroup
1C
at
0.1
ppm,
Okra
at
0.5
ppm,
dried
shelled
pea
and
bean,
subgroup
6C
at
0.1
ppm,
Cilantro
at
5.0
ppm
when
bifenthrin
is
applied
following
the
proposed
use
directions.

B.
Toxicological
Profile
1.
Acute
toxicity.
For
the
purposes
of
assessing
acute
dietary
risk,
FMC
has
used
the
results
of
the
2003
EPA
completed
risk
assessment
for
bifenthrin.
This
acute
dietary
endpoint
used
to
determine
acute
dietary
risks
to
the
general
population
including
infants
and
children
is
from
the
acute
neurotoxicity
study
in
rats,
LOAEF
=
70.3
mg
ai/
kg,
NOAEL
=
32.8
mg
ai/
kg,
UF
=
1000,
Acute
RfD
=
0.033
mg/
kg/
day
2.
Genotoxicty.
The
mouse
lymphoma
mutagenesis
assay
gave
a
weak
positive
result;
however,
the
weight
of
the
evidence
from
short­
term
mutagenicity
tests
indicate
that
bifenthrin
is
not
mutagenic.

3.
Reproductive
and
developmental
toxicity.
i.
Rat
reproduction
study.
Parental
toxicity
occurred
as
decreased
body
weight
at
5.0
mg/
kg/
day
with
a
no
observed
adverse
effect
level
(
LOAEL)
of
3.0
mg/
kg/
day.
There
were
no
developmental
(
pup)
or
reproductive
effects
up
to
5.0
mg/
kg/
day
(
highest
dose
tested).

ii.
Postnatal
Sensitivity.
Based
on
the
absence
of
pup
toxicity
up
to
dose
levels,
which
produced
toxicity
in
the
parental
animals,
there
was
no
evidence
of
special
postnatal
sensitivity
to
infants
and
children
in
the
rat
reproduction
study.
In
a
developmental
neurotoxicity
study,
pups
were
not
more
sensitive
than
the
dams.
The
NOELs
for
maternal
and
developmental
neurotoxicity
were
both
50
ppm.

4.
Subchronic
toxicity.
The
results
of
the
21­
day
dermal
toxicity
study
in
rats
is
used
for
short­
term
(
1­
30
days),
intermediate­
term
(
1­
6
months)
and
long­
term
(>
6
months)
dermal
risk
calculations.
The
21­
day
dermal
toxicity
study
NOEL
for
systemic
toxicity
is
47
mg
ai/
kg/
day
based
on
observations
of
clinical
signs
(
exaggerated
hindlimb
flexion
and
staggered
gait).

5.
Chronic
toxicity.
The
reference
dose
(
RfD)
has
been
established
at
0.004
mg/
kg/
day.
This
RfD
is
based
on
a
one­
year
oral
study
in
dogs
with
a
LOAEF
of
2.7
mg
ai/
kg/
day
and
a
NOAEL
of
1.3
mg
ai/
kg/
day,
UF
=
300
based
on
observations
of
increased
incidence
of
tremors
in
both
sexes.

ii.
Bifenthrin
is
classified
as
a
Group
C
chemical
(
possible
human
carcinogen);
No
Q1*
has
been
derived.

6.
Animal
metabolism.
The
metabolism
of
bifenthrin
in
animals
is
adequately
understood.
Metabolism
studies
in
rats
with
single
doses
demonstrated
that
about
90%
of
the
parent
compound
and
its
hydroxylated
metabolites
are
excreted.

7.
Metabolite
toxicology.
The
Agency
has
previously
determined
that
the
metabolites
of
bifenthrin
are
not
of
toxicological
concern
and
need
not
be
included
in
the
tolerance
expression.

8.
Endocrine
disruption.
No
special
studies
investigating
potential
estrogenic
or
other
endocrine
effects
of
bifenthrin
have
been
conducted.
However,
no
evidence
of
such
effects
was
reported
in
the
standard
battery
of
required
toxicology
studies,
which
have
been
completed
and
found
acceptable.
Based
on
these
studies,
there
is
no
evidence
to
suggest
that
bifenthrin
has
an
adverse
effect
on
the
endocrine
system.

C.
Aggregate
Exposure
1.
Dietary
exposure.
Tolerances
have
been
established
for
the
residues
of
bifenthrin,
in
or
on
a
variety
of
raw
agricultural
commodities.
Tolerances,
in
support
of
registrations,
currently
exist
for
residues
of
bifenthrin
on
the
following
crops:
hops,
strawberries,
corn
(
grain,
forage
and
fodder),
sweet
corn,
eggplant,
cottonseed,
artichokes,
peppers
(
bell
and
non­
bell),
lettuce
(
head),
grapes,
spinach,
cabbage,
rapeseed,
tomatoes,
Food
Handling
Establishments,
banana
(
import)
and
pears.
Also
for
the
crop
groups:
vegetables,
cucurbit,
group
9,
fruit,
citrus,
group
10
and
nuts,
tree,
group
14
and
the
subgroups:
vegetable,
legume,
edible
podded,
subgroup
6A,
pea
and
bean,
succulent
shelled,
subgroup
6B,
caneberry
subgroup
13A,
and
brassica,
head
and
stem,
subgroup
5A
and
herb
subgroup
19A.
Also,
for
the
livestock
commodities
of
cattle,
goats,
hogs,
horses,
sheep,
poultry,
eggs,
and
milk.
Pending
tolerances
for
leaf
petioles
subgroup
4B,
vegetables
tuberous
and
corm,
subgroup
1C,
pea
and
bean,
dried
shelled,
except
soybeans,
subgroup
6C
also
exist.
For
the
purposes
of
assessing
the
potential
dietary
exposure
for
these
existing
and
pending
tolerances,
EPA
conducted
an
exposure
estimate
using
Dietary
Exposure
Evaluation
Model
(
DEEM)
software
version
7.76,
results
from
field
trials
and
processing
studies,
monitoring
data,
consumption
data
from
the
1989­
1992,
USDA
Continuing
Surveys
of
Food
Intakes
by
Individuals
(
CSFII),
and
information
on
the
percentages
of
the
crops
treated
(
where
available)
with
bifenthrin
were
utilized.
i.
Food.
a.
Acute
Dietary
Exposure
risk
assessments
are
performed
for
a
food­
use
pesticide
if
a
toxicological
study
has
indicated
the
possibility
of
an
effect
of
concern
occurring
as
a
result
of
a
1­
day
or
single
exposure.
For
the
purposes
of
assessing
acute
dietary
risk,
FMC
has
used
the
results
of
the
2003
EPA
completed
risk
assessment
for
bifenthrin.
This
acute
dietary
endpoint
used
to
determine
acute
dietary
risks
to
the
general
population
including
infants
and
children
is
from
the
acute
neurotoxicity
study
in
rats,
LOAEF
=
70.3
mg
ai/
kg,
NOAEL
=
32.8
mg
ai/
kg,
UF
=
1000,
Acute
RfD
=
0.0328
mg/
kg/
day.
Available
information
on
anticipated
residues,
monitoring
data
and
percent
crop
treated
(
if
no
estimate
was
available
the
conservative
estimate
of
50%
crop
treatment
was
used)
were
incorporated
into
a
Tier
1+
analysis;
using
Monte
Carlo
modeling
for
commodities
that
may
be
consumed
in
a
single
serving.
These
assessments
demonstrate
that
the
MOEs
at
the
99.9th
percentile
are
greater
than
the
EPA
standard
of
100%
aPAD
for
all
subpopulations.
The
99.9th
percentile
of
exposure
for
the
overall
U.
S.
Population
is
estimated
to
be
0.010601
mg/
kg/
day
(
32%
aPAD).
The
99.9th
percentile
of
exposure
for
children
1
to
6
years
old
(
most
highly
exposed
population
subgroup)
is
estimated
to
be
0.016522
mg/
kg/
day
(
50%
aPAD).
The
99.9th
percentile
of
exposure
to
all
infants
less
than
1
year
old
is
estimated
to
be
0.014314
mg/
kg/
day
(
44%
aPAD).
Based
on
the
conservatism
used
in
the
analyses,
actual
dietary
exposure
will
be
less
than
that
presented
here.
FMC
concludes
that
based
on
adequate
%
aPAD
for
all
population
subgroups
there
is
reasonable
certainty
that
no
harm
will
result
from
the
proposed
additional
uses
of
bifenthrin.
b.
Chronic
Exposure.
The
reference
dose
(
RfD)
has
been
established
at
0.004
mg/
kg/
day.
This
RfD
is
based
on
a
one­
year
oral
study
in
dogs
with
a
LOAEF
of
2.7
mg
ai/
kg/
day
and
a
NOAEL
of
1.3
mg
ai/
kg/
day,
UF
=
300
based
on
observations
of
increased
incidence
of
tremors
in
both
sexes.
The
chronic
exposures
for
the
U.
S.
Population
are
estimated
to
be
0.001310
mg/
kg/
day
and
utilize
33%
of
the
cPAD.
The
chronic
exposures
for
Children
1
to
6
years
old
(
most
highly
exposed
population
subgroup)
is
estimated
to
be
0.003480
mg/
kg/
day
and
utilizes
87%
of
the
cPAD.
Chronic
dietary
exposure
estimates
for
all
infants
(<
1
year
old)
is
estimated
to
be
0.001276
mg/
kg/
day
and
utilizes
32%
of
the
cPAD.
Therefore,
FMC
concludes
with
reasonable
certainty
that
no
harm
will
result
from
the
proposed
additional
uses
of
bifenthrin.

ii.
Drinking
water.
US
EPA's
draft
SOP
for
Incorporating
Estimates
of
Drinking
Water
Exposure
into
Aggregate
Risk
Assessments
was
used
to
perform
a
drinking
water
analysis.
This
SOP
utilizes
a
variety
of
tools
to
conduct
drinking
water
assessment.
These
tools
include
water
models
such
as
FQPA
Index
Reservoir
Screening
Tool
(
FIRST),
PRZM/
EXAMS,
SCIGROW
and
monitoring
data.
If
monitoring
data
are
not
available
then
the
models
are
used
to
predict
potential
residues
in
surface
water.
A
comparison
of
the
calculated
Drinking
Water
Level
of
Concern
(
DWLOC)
value
to
the
Estimated
Environmental
Concentration
(
EEC)
is
made.
If
the
DWLOC
exceeds
the
EEC
value
then
there
is
reasonable
certainty
that
no
harm
will
result
from
the
short­
or
intermediate­
term
aggregate
exposure.
In
the
case
of
bifenthrin,
monitoring
data
do
not
exist,
so
the
FIRST
model
was
used
to
estimate
a
surface
water
residue
and
SCIGROW
for
the
groundwater.
Based
on
the
analyses
the
acute
aggregate
exposures
to
bifenthrin
residues,
the
DWLOC
for
all
seasons
for
the
US
population
was
777
ppb
while
the
modeled
EEC,
was
0.1
and
0.006
ppb
for
surface
water
and
ground
water
respectively.
For
children
(
1­
6
year
old),
the
DWLOCs
was
244
ppb
while
the
modeled
EEC
was
the
same
as
that
for
the
whole
US
population.
For
the
chronic
aggregate
exposures
to
bifenthrin
residues,
the
DWLOC
for
all
seasons
for
the
US
population
was
94
ppb
while
the
modeled
EEC,
was
0.1
and
0.006
ppb
for
surface
water
and
ground
water
respectively.
For
children
(
1­
6
year
old),
the
DWLOCs
was
8
ppb
while
the
modeled
EEC
was
the
same
as
that
for
the
whole
US
population.
Since,
the
calculated
DWLOC
values
for
all
population
subgroups
exceeded
the
modeled
EEC
for
surface
water
and
ground
water
residues,
there
is
reasonable
certainty
that
no
harm
will
result
from
aggregate
exposures
to
bifenthrin
residues.

2.
Non­
dietary
exposure.
The
aggregate
residential
exposure
analyses
were
based
on
conservative
screening­
level
assumptions.
The
residential
risk
assessments
resulted
in
acceptable
MOEs
and
a
clear
indication
of
reasonable
certainty
of
no
harm.
The
short­
term
analyses,
all
of
the
route­
and
product­
specific
MOEs
were
greater
than
300
and
the
aggregate
MOEs
were
greater
than
300
for
all
population
subgroups.
Based
on
the
above
information,
FMC
concludes
that
bifenthrin
does
not
pose
a
risk
due
to
short­
and
intermediate­
term
aggregate
exposure.

D.
Cumulative
Effects
To
our
knowledge
there
are
currently
no
available
data
or
other
reliable
information
indicating
that
any
toxic
effects
produced
by
bifenthrin
would
be
cumulative
with
those
of
other
chemical
compounds;
thus
only
the
potential
risks
of
bifenthrin
have
been
considered
in
this
assessment
of
its
aggregate
exposure.
E.
Safety
Determination
1.
U.
S.
population.
Using
the
conservative
exposure
assessment
analyses
the
estimated
chronic
exposure
to
the
U.
S.
Population
is
0.001310
mg/
kg/
day
and
utilizes
33%
of
the
cPAD.
In
addition,
the
chronic
exposure
estimates
for
all
population
subgroups
(
including
infants
and
children)
are
well
below
the
cPAD
of
0.004
mg/
kg/
day.
The
acute
dietary
exposure
analyses
at
the
99.9th
percentile
for
the
U.
S.
Population
is
0.010601
and
utilizes
32%
of
the
aPAD.
In
addition,
the
acute
exposure
estimates
for
population
subgroups
of
concern
(
infants
and
children)
indicate
that
the
maximum
%
aPAD
or
%
cPAD
utilized
is
50%
(
aPAD)
and
87%
(
cPAD)
.
Based
on
this
information
FMC
concludes
that
there
is
reasonable
certainty
that
no
harm
will
result
from
acute
and
chronic
exposure
to
bifenthrin.
2.
Infants
and
children.
i.
General.
In
assessing
the
potential
for
additional
sensitivity
of
infants
and
children
to
residues
of
bifenthrin,
FMC
considered
data
from
developmental
toxicity
studies
in
the
rat
and
rabbit,
a
developmental
neurotoxicity
study,
and
a
two­
generation
reproduction
study
in
the
rat.
The
developmental
toxicity
studies
are
designed
to
evaluate
adverse
effects
on
the
developing
organism
resulting
from
pesticide
exposure
during
prenatal
development
to
one
or
both
parents.
Reproduction
studies
provide
information
relating
to
effects
from
exposure
to
the
systemic
toxicity.
FFDCA
Section
408
provides
that
the
EPA
may
apply
an
additional
margin
of
safety
for
infants
and
children
in
the
case
of
threshold
effects
to
account
for
prenatal
and
postnatal
toxicity
and
completeness
of
the
database.
ii.
Developmental
toxicity
studies.
In
the
rabbit
developmental
study,
there
were
no
developmental
effects
observed
in
the
fetuses
exposed
to
bifenthrin.
The
maternal
NOAEL
was
2.67
mg/
kg/
day
based
on
head
and
forelimb
twitching
at
the
LOAEL
of
4
mg/
kg/
day.
In
the
rat
developmental
study,
the
maternal
NOEL
was
7.4
mg/
kg/
day,
based
on
treatment­
related
clinical
signs
and
reductions
in
body
weights,
adjusted
maternal
body
weights,
and
corresponding
reductions
in
food
consumption
noted
among
dams
receiving
the
LOEL
of
16.3
mg/
kg/
day.
The
developmental
NOEL
was
greater
than
16.3
mg/
kg/
day
based
on
lack
of
any
adverse
fetal
effects
at
levels
up
to
and
including
16.3
mg/
kg/
day.
iii.
Developmental
neurotoxicity
study.
In
a
rat
developmental
neurotoxicity
study,
pups
were
not
more
sensitive
than
the
dams.
The
NOEL
for
maternal
toxicity
was
50
ppm,
based
on
tremors
at
the
LOEL
of
100
ppm.
The
NOEL
for
developmental
neurotoxicity
was
also
50
ppm.
iv.
Reproductive
toxicity
study.
In
the
rat
reproduction
study,
parental
toxicity
occurred
as
decreased
body
weight
at
5.0
mg/
kg/
day
with
a
NOAEL
of
3.0
mg/
kg/
day.
There
were
no
developmental
(
pup)
or
reproductive
effects
up
to
5.0
mg/
kg/
day
(
highest
dose
tested).
v.
Conclusion.
Based
on
the
absence
of
fetal
effects
and
pup
toxicity
in
any
of
the
referenced
studies,
FMC
concludes
that
reliable
data
support
use
of
the
standard
100­
fold
uncertainty
factor,
and
that
an
additional
uncertainty
factor
is
not
needed
to
protect
the
safety
of
infants
and
children.
As
previously
stated,
aggregate
exposure
assessments
utilized
no
more
than
87%
of
the
aPAD
or
cPAD
for
either
the
entire
U.
S.
Population
or
any
of
the
population
subgroups
including
infants
and
children.
Therefore,
it
may
be
concluded
that
there
is
reasonable
certainty
that
no
harm
will
result
to
infants
and
children
from
aggregate
exposure
to
bifenthrin
residues.

F.
International
Tolerances
There
are
no
Codex,
Canadian,
or
Mexican
residue
limits
for
the
residue
of
bifenthrin
in
or
on
leafy
brassica
greens,
tuberous
and
corm
vegetables,
okra,
cilantro
and
dried
shelled
pea
and
bean.