Document ID: EPA-HQ-OPP-2002-0358-0001
Agency: epa
Document Type: Rule
Title: Bifenthrin; Pesticide Tolerance
Posted Date: 2003-04-30T04:00Z

23056
Federal
Register
/
Vol.
68,
No.
83
/
Wednesday,
April
30,
2003
/
Rules
and
Regulations
(
b)
Section
18
emergency
exemptions.
[
Reserved]
(
c)
Tolerances
with
regional
registrations.
[
Reserved]
(
d)
Indirect
or
inadvertent
residues.
[
Reserved]
[
FR
Doc.
03
 
10264
Filed
4
 
29
 
03;
8:
45
am]

BILLING
CODE
6560
 
50
 
S
ENVIRONMENTAL
PROTECTION
AGENCY
40
CFR
Part
180
[
OPP
 
2002
 
0358;
FRL
 
7304
 
4]

Bifenthrin;
Pesticide
Tolerance
AGENCY:
Environmental
Protection
Agency
(
EPA).
ACTION:
Final
rule.

SUMMARY:
This
regulation
establishes
tolerances
for
residues
of
bifenthrin
in
or
on
almond,
hulls;
banana;
fruit,
citrus,
group;
herb
subgroup;
pear;
nut,
tree,
group;
spinach;
tomato;
and
food/
feed
products
in
food/
feed
handling
establishments.
FMC
Corporation
and
the
Interregional
Research
Project
Number
4
(
IR­
4)
requested
these
tolerances
under
the
Federal
Food,
Drug,
and
Cosmetic
Act
(
FFDCA)
,
as
amended
by
the
Food
Quality
Protection
Act
of
1996
(
FQPA).
DATES:
This
regulation
is
effective
April
30,
2003.
Objections
and
requests
for
hearings,
identified
by
docket
ID
number
OPP
 
2002
 
0358,
must
be
received
on
or
before
June
30,
2003.
ADDRESSES:
Written
objections
and
hearing
requests
may
be
submitted
electronically,
by
mail,
or
through
hand
delivery/
courier.
Follow
the
detailed
instructions
as
provided
in
Unit
VI.
of
the
SUPPLEMENTARY
INFORMATION.
FOR
FURTHER
INFORMATION
CONTACT:
Susan
Stanton,
Registration
Division
(
7505C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001;
telephone
number:
(
703)
305
 
5218;
e­
mail
address:
stanton.
susan@
epa.
gov.

SUPPLEMENTARY
INFORMATION:

I.
General
Information
A.
Does
this
Action
Apply
to
Me?

You
may
be
affected
by
this
action
if
you
are
an
agricultural
producer;
food/
feed
or
beverage
manufacturer,
wholesale
or
retailer;
restaurant
owner/
worker;
or
pesticide
manufacturer.
Potentially
affected
entities
may
include,
but
are
not
limited
to:
 
Crop
producers
(
NAICS
111),
e.
g.,
tree
fruit
and
nut
growers,
tomato
growers
and
herb
producers
 
Animal
producers
(
NAICS
112),
including
cattle,
sheep,
swine,
dairy,
and
poultry
producers
 
Food
and
beverage
manufacturers
(
NAICS
311),
including
canners,
bottlers,
brewers,
bakers
and
other
food
and
beverage
processors
 
Food
and
beverage
stores
(
NAICS
445)
 
Restaurants
(
NAICS
722)
 
Pesticide
manufacturers
(
NAICS
32532)
This
listing
is
not
intended
to
be
exhaustive,
but
rather
provides
a
guide
for
readers
regarding
entities
likely
to
be
affected
by
this
action.
Other
types
of
entities
not
listed
in
this
unit
could
also
be
affected.
The
North
American
Industrial
Classification
System
(
NAICS)
codes
have
been
provided
to
assist
you
and
others
in
determining
whether
this
action
might
apply
to
certain
entities.
If
you
have
any
questions
regarding
the
applicability
of
this
action
to
a
particular
entity,
consult
the
person
listed
under
FOR
FURTHER
INFORMATION
CONTACT.

B.
How
Can
I
Get
Copies
of
this
Document
and
Other
Related
Information?
1.
Docket.
EPA
has
established
an
official
public
docket
for
this
action
under
docket
identification
(
ID)
number
OPP
 
2002
 
0358.
The
official
public
docket
consists
of
the
documents
specifically
referenced
in
this
action,
any
public
comments
received,
and
other
information
related
to
this
action.
Although
a
part
of
the
official
docket,
the
public
docket
does
not
include
Confidential
Business
Information
(
CBI)
or
other
information
whose
disclosure
is
restricted
by
statute.
The
official
public
docket
is
the
collection
of
materials
that
is
available
for
public
viewing
at
the
Public
Information
and
Records
Integrity
Branch
(
PIRIB),
Rm.
119,
Crystal
Mall
#
2,
1921
Jefferson
Davis
Hwy.,
Arlington,
VA.
This
docket
facility
is
open
from
8:
30
a.
m.
to
4
p.
m.,
Monday
through
Friday,
excluding
legal
holidays.
The
docket
telephone
number
is
(
703)
305
 
5805.
2.
Electronic
access.
You
may
access
this
Federal
Register
document
electronically
through
the
EPA
Internet
under
the
``
Federal
Register''
listings
at
http://
www.
epa.
gov/
fedrgstr/.
A
frequently
updated
electronic
version
of
40
CFR
part
180
is
available
at
http://
www.
access.
gpo.
gov/
nara/
cfr/
cfrhtml_
00/
Title_
40/
40cfr180_
00.
html,
a
beta
site
currently
under
development.
To
access
the
OPPTS
Harmonized
Guidelines
referenced
in
this
document,
go
directly
to
the
guidelines
at
http://
www.
epa.
gov/
opptsfrs/
home/
guidelin.
htm.
An
electronic
version
of
the
public
docket
is
available
through
EPA's
electronic
public
docket
and
comment
system,
EPA
Dockets.
You
may
use
EPA
Dockets
at
http://
www.
epa.
gov/
edocket/
to
submit
or
view
public
comments,
access
the
index
listing
of
the
contents
of
the
official
public
docket,
and
to
access
those
documents
in
the
public
docket
that
are
available
electronically.
Although
not
all
docket
materials
may
be
available
electronically,
you
may
still
access
any
of
the
publicly
available
docket
materials
through
the
docket
facility
identified
in
Unit
I.
B.
1.
Once
in
the
system,
select
``
search,''
then
key
in
the
appropriate
docket
ID
number.

II.
Background
and
Statutory
Findings
In
the
Federal
Register
of
February
15,
2002
(
67
FR
7159
 
7163)
(
FRL
 
6823
 
3);
February
14,
2001
(
66
FR
10289
 
10292)
(
FRL
 
6768
 
7);
and
April
25,
2001
(
66
FR
20811
 
20815)
(
FRL
 
6778
 
4),
EPA
issued
notices
pursuant
to
section
408
of
FFDCA,
21
U.
S.
C.
346a,
as
amended
by
FQPA
(
Public
Law
104
 
170),
announcing
the
filing
of
pesticide
petitions
(
PP
2F6390,
6F3454,
0E6216
and
1F6266)
by
FMC
Corporation;
(
PP
6E4630,
0E6157,
1E6330
and
2E6402)
by
the
Interregional
Research
Project
Number
4
(
IR­
4);
and
(
PP
1E6234)
by
the
Taipei
Economic
and
Cultural
Representative
Office.
These
notices
included
summaries
of
the
petitions
prepared
by
FMC
Corporation,
the
registrant.
There
were
no
comments
received
in
response
to
the
notices
of
filing.
These
petitions
requested
that
40
CFR
180.442
be
amended
by
establishing
tolerances
for
residues
of
the
insecticide
bifenthrin,
(
2­
methyl[
1,1 ­
biphenyl]­
3­
yl)
methyl­
3­(
2­
chloro­
3,3,3­
trifluoro­
1­
propenyl)­
2,2­
dimethylcyclopropanecarboxylate
as
follows:
1.
PP
2F6390
proposed
establishment
of
a
tolerance
for
food
products
in
food
handling
establishments
at
0.01
ppm.
2.
PP
6F3454
proposed
establishment
of
a
tolerance
for
pears
at
1.0
ppm;
almond
hulls
at
2
ppm;
and
tree
nuts
crop
group
at
0.05
ppm.
3.
PP
0E6216
proposed
establishment
of
a
tolerance
for
imported
bananas
at
0.1
ppm.
4.
PP
1F6266
proposed
establishment
of
a
tolerance
for
citrus
whole
fruits,
citrus
dried
pulp,
citrus
cold
pressed
oil
and
citrus
juice
at
0.05
ppm.
5.
PP
6E4630
proposed
establishment
of
a
tolerance
for
leaf
petioles
subgroup
(
4B)
at
2.0
ppm.
6.
PP
0E6157
proposed
establishment
of
a
tolerance
for
herb
subgroup
(
19A)
at
0.05
ppm.
7.
PP
1E6330
proposed
establishment
of
a
tolerance
for
tomato
at
0.15
ppm.

VerDate
Jan<
31>
2003
16:
41
Apr
29,
2003
Jkt
200001
PO
00000
Frm
00032
Fmt
4700
Sfmt
4700
E:\
FR\
FM\
30APR1.
SGM
30APR1
23057
Federal
Register
/
Vol.
68,
No.
83
/
Wednesday,
April
30,
2003
/
Rules
and
Regulations
8.
PP
2E6402
proposed
establishment
of
a
tolerance
for
spinach
at
0.2
ppm.
9.
PP
1E6234
proposed
establishment
of
a
tolerance
for
carambola
(
starfruit)
at
1.0
ppm.
The
residue
chemistry
data
submitted
in
support
of
PP
6E4630
(
leaf
petioles
subgroup)
and
PP
1E6234
(
carambola)
were
determined
by
EPA
to
be
insufficient
to
support
the
proposed
tolerances.
PP
1E6234
was
subsequently
withdrawn
by
the
Taipei
Economic
and
Cultural
Representative
Office.
The
requested
tolerance
for
the
leaf
petioles
subgroup
(
PP
6E4630)
cannot
be
established
until
adequate
residue
chemistry
data
are
submitted
and
reviewed.
Based
on
EPA's
review,
the
remaining
petitions
described
in
Unit
II
were
revised
by
the
petitioners
(
FMC
Corporation
and
IR­
4)
to
propose
tolerances
for
residues
of
bifenthrin
in
or
on
almond,
hulls
at
2.0
ppm;
banana
at
0.1
ppm;
fruit,
citrus,
group
at
0.05
ppm;
herb
subgroup
at
0.05
ppm;
pear
at
0.5
ppm;
nut,
tree,
group
at
0.05
ppm;
spinach
at
0.2
ppm;
tomato
at
0.15
ppm;
and
food/
feed
products
in
food/
feed
handling
establishments
at
0.05
ppm.
The
revisions
were
requested
for
the
following
reasons:
EPA
determined
that
the
tolerance
for
pear
should
be
set
at
0.5
ppm,
not
1.0
ppm
as
the
petitioner
originally
proposed,
based
on
the
results
of
submitted
field
residue
data,
showing
a
maximum
residue
of
0.38
ppm.
EPA
determined
that
the
tolerance
for
food/
feed
products
in
food/
feed
handling
establishments
should
be
set
at
0.05
ppm,
the
limit
of
quantitation
(
LOQ)
of
the
analytical
method,
rather
than
0.01
ppm,
the
limit
of
detection
(
LOD),
as
the
petitioner
originally
proposed.
It
is
Agency
policy
to
use
the
LOQ
for
setting
tolerances
when
detectable
residues
are
not
found
in
the
residue
trials.
No
other
changes
to
the
originally
proposed
tolerance
levels
were
requested;
however,
EPA
did
request
minor
changes
in
commodity
terms
to
reflect
current
nomenclature
practices.
Although
EPA
requested
changes
to
the
initial
petitions,
the
nature
of
the
changes
is
not
considered
significant.
Therefore,
EPA
is
issuing
this
as
a
final
action.
EPA
is
also
deleting
time­
limited
tolerances
established
for
residues
of
bifenthrin
in
or
on
citrus,
dried
pulp,
at
0.3
ppm,
citrus
oil
at
0.3
ppm
and
citrus,
whole
fruit,
at
0.05
ppm
in
connection
with
section
18
emergency
exemptions
granted
by
EPA.
With
the
establishment
of
the
citrus
fruit
group
tolerance
(
PP
1F6266),
these
tolerances
are
no
longer
needed.
Section
408(
b)(
2)(
A)(
i)
of
the
FFDCA
allows
EPA
to
establish
a
tolerance
(
the
legal
limit
for
a
pesticide
chemical
residue
in
or
on
a
food)
only
if
EPA
determines
that
the
tolerance
is
``
safe.''
Section
408(
b)(
2)(
A)(
ii)
of
the
FFDCA
defines
``
safe''
to
mean
that
``
there
is
a
reasonable
certainty
that
no
harm
will
result
from
aggregate
exposure
to
the
pesticide
chemical
residue,
including
all
anticipated
dietary
exposures
and
all
other
exposures
for
which
there
is
reliable
information.''
This
includes
exposure
through
drinking
water
and
in
residential
settings,
but
does
not
include
occupational
exposure.
Section
408(
b)(
2)(
C)
of
the
FFDCA
requires
EPA
to
give
special
consideration
to
exposure
of
infants
and
children
to
the
pesticide
chemical
residue
in
establishing
a
tolerance
and
to
``
ensure
that
there
is
a
reasonable
certainty
that
no
harm
will
result
to
infants
and
children
from
aggregate
exposure
to
the
pesticide
chemical
residue....''
EPA
performs
a
number
of
analyses
to
determine
the
risks
from
aggregate
exposure
to
pesticide
residues.
For
further
discussion
of
the
regulatory
requirements
of
section
408
of
the
FFDCA
and
a
complete
description
of
the
risk
assessment
process,
see
the
final
rule
on
Bifenthrin
Pesticide
Tolerances
(
62
FR
62961,
November
26,
1997)
(
FRL
 
5754
 
7).

III.
Aggregate
Risk
Assessment
and
Determination
of
Safety
Consistent
with
section
408(
b)(
2)(
D)
of
the
FFDCA,
EPA
has
reviewed
the
available
scientific
data
and
other
relevant
information
in
support
of
this
action.
EPA
has
sufficient
data
to
assess
the
hazards
of
and
to
make
a
determination
on
aggregate
exposure,
consistent
with
section
408(
b)(
2)
of
the
FFDCA,
for
a
tolerance
for
residues
of
bifenthrin
in
or
on
almond,
hulls
at
2.0
ppm;
banana
at
0.1
ppm;
fruit,
citrus,
group
10
at
0.05
ppm;
herb
subgroup
19A
at
0.05
ppm;
pear
at
0.5
ppm;
nut,
tree,
group
14
at
0.05
ppm;
spinach
at
0.2
ppm;
tomato
at
0.15
ppm;
and
food/
feed
products
in
food/
feed
handling
establishments
at
0.05
ppm.
EPA's
assessment
of
exposures
and
risks
associated
with
establishing
the
tolerance
follows.

A.
Toxicological
Profile
EPA
has
evaluated
the
available
toxicity
data
and
considered
its
validity,
completeness,
and
reliability
as
well
as
the
relationship
of
the
results
of
the
studies
to
human
risk.
EPA
has
also
considered
available
information
concerning
the
variability
of
the
sensitivities
of
major
identifiable
subgroups
of
consumers,
including
infants
and
children.
The
nature
of
the
toxic
effects
caused
by
bifenthrin
are
discussed
in
Table
1
of
this
unit
as
well
as
the
no­
observed­
adverse­
effect­
level
(
NOAEL)
and
the
lowest­
observedadverse
effect­
level
(
LOAEL)
from
the
toxicity
studies
reviewed.

TABLE
1.
 
SUBCHRONIC,
CHRONIC,
AND
OTHER
TOXICITY
Guideline
Number
Study
Type
Results
870.3100
90
 
Day
Oral
Toxicity
­
Rat
(
1984)
NOAEL
=
3.8
mg/
kg/
day
(
males);
4.3
mg/
kg/
day
(
females)
LOAEL
=
7.5
mg/
kg/
day
(
males),
8.5
mg/
kg/
day
(
females),
based
on
increased
incidence
of
tumors.
Classification:
Acceptable­
Guideline
870.3150
90
 
Day
Oral
Toxicity
­
Dog
(
1984)
NOAEL
=
2.21
mg/
kg/
day
(
males
and
females)
LOAEL
=
4.42
mg/
kg/
day
(
males
and
females)
based
on
increased
incidence
of
tremors.
Classification:
Acceptable­
Guideline
870.3700
Developmental
Toxicity
(
Gavage;
corn
oil
vehicle)
­
Rat
(
1983)
Maternal
Toxicity
NOAEL
=
0.88
mg/
kg/
day
LOAEL
=
1.77
mg/
kg/
day
based
on
tremors
during
gestation.
Developmental
Toxicity
NOAEL
=
not
determined
(
fetuses
not
examined)
LOAEL
=
not
determined
(
fetuses
not
examined)
Classification:
Acceptable­
Guideline
VerDate
Jan<
31>
2003
12:
41
Apr
29,
2003
Jkt
200001
PO
00000
Frm
00033
Fmt
4700
Sfmt
4700
E:\
FR\
FM\
30APR1.
SGM
30APR1
23058
Federal
Register
/
Vol.
68,
No.
83
/
Wednesday,
April
30,
2003
/
Rules
and
Regulations
TABLE
1.
 
SUBCHRONIC,
CHRONIC,
AND
OTHER
TOXICITY
 
Continued
Guideline
Number
Study
Type
Results
870.3700
Developmental
Toxicity
(
Gavage;
corn
oil
vehicle)
­
Rat
(
1984)
Maternal
Toxicity
NOAEL
=
0.88
mg/
kg/
day
LOAEL
=
1.77
mg/
kg/
day
based
on
tremors
during
gestation.
Developmental
Toxicity
NOAEL
=
0.88
mg/
kg/
day
LOAEL
=
1.77
mg/
kg/
day
based
on
increased
fetal
and
litter
incidence
of
hydroureter
without
nephrosis.
Classification:
Acceptable­
Guideline
870.3700
Developmental
Toxicity
(
Dietary
­
Rat
(
2001)
Maternal
Toxicity
NOAEL
=
7.1
mg/
kg/
day
LOAEL
=
15.5
mg/
kg/
day
based
clinical
signs
and
decreased
food
consumption,
body
weight
gains,
and
body
weight
gains
adjusted
for
gravid
uterine
weight.
Developmental
Toxicity
NOAEL
=
15.5
mg/
kg/
day
LOAEL
=
not
observed.
Classification:
Acceptable­
Guideline
870.3700
Developmental
Toxicity
­
Rabbit
(
1984)
Maternal
Toxicity
NOAEL
=
2.36
mg/
kg/
day
LOAEL
=
3.5
mg/
kg/
day
based
on
treatment­
related
head
and
forelimb
twitching.
Developmental
Toxicity
NOAEL
=
greater
than
7
mg/
kg/
day
LOAEL
=
not
observed
Classification:
Acceptable­
Guideline
870.3800
Multigeneration
Reproductive
Toxicity
­
Rat
(
1986)
Parental/
Systemic
Toxicity
NOAEL
=
3.0
mg/
kg/
day
for
females
and
5.0
mg/
kg/
day
for
males
LOAEL
=
5.0
mg/
kg/
day
for
females,
based
on
tremors
and
decreased
body
weight;
not
observed
for
males.
Reproductive/
offspring
Toxicity
NOAEL
=
not
observed.
LOAEL
=
not
observed.
Classification:
Acceptable­
Guideline
870.4100
Chronic
Toxicity
­
Dog
(
1985)
NOAEL
=
1.3
mg/
kg/
day
(
males
and
females)
LOAEL
=
2.7
mg/
kg/
day
(
males
and
females)
based
on
increased
incidence
of
tremors.
Classification:
Acceptable­
Guideline
870.4300
Combined
Chronic
Toxicity/
Carcinogenicity
­
Rat
(
1986)
NOAEL
=
3.0
mg/
kg/
day
(
females);
4.7
mg/
kg/
day
(
males)
LOAEL
=
6.1
mg/
kg/
day
(
females),
based
on
increased
incidence
of
tremors;
9.7
mg/
kg/
day
(
males),
based
on
increased
incidence
of
tremors.
Carcinogenicity
­
No
conclusive
evidence
of
carcinogenic
potential.
Classification:
Acceptable­
Guideline
870.4200
Carcinogenicity
­
Mice
(
1986)
NOAEL
=
6.7
mg/
kg/
day
(
males);
8.8
mg/
kg/
day
(
females)
LOAEL
=
25.6
mg/
kg/
day
(
males)
and
32.7
mg/
kg/
day
(
females),
based
on
increased
incidence
of
tremors.
Carcinogenicity
­
carcinogenic
potential
was
evidenced
by
a
dose­
related
increased
in
the
incidence
of
leiomyosarcomas
in
the
urinary
bladder,
a
significant
dose­
related
trend
for
combined
hepatocellular
adenomas
and
carcinomas
in
males,
and
a
significantly
higher
incidence
of
combined
lung
adenomas
and
carcinomas
in
females.
Classification:
Acceptable­
Guideline
870.6200
Acute
Neurotoxicity
­
Rat
NOAEL
=
35
mg/
kg
(
32.8
mg
ai/
kg/
day).
LOAEL
=
75
mg/
kg
(
70.3
mg
ai/
kg/
day)
based
on
mortality
(
females
only),
clinical
and
functional
operational
battery
(
FOB)
findings
and
differences
in
motor
activity.
Classification:
Acceptable­
Guideline
870.6200
Subchronic
Neurotoxicity
­
Rat
NOAEL
=
50
ppm
(
equivalent
to
2.9
mg/
kg/
day
in
males
and
3.7
mg/
kg/
day
in
females).
LOAEL
=
100
ppm
(
equivalent
to
6.0
mg/
kg/
day
in
males
and
7.2
mg/
kg/
day
in
females)
based
on
neuromuscular
findings
(
tremors,
changes
in
grip
strength
and
landing
footsplay
Classification:
Acceptable­
Guideline
870.3200
Dermal
Toxicity
­
Rabbit
NOAEL
=
88
mg
ai/
kg/
day
(
males
and
females)
LOAEL
=
442
mg
ai/
kg/
day
(
males
and
females),
based
on
loss
of
muscle
coordination
and
increased
incidence
of
tremors.

VerDate
Jan<
31>
2003
12:
41
Apr
29,
2003
Jkt
200001
PO
00000
Frm
00034
Fmt
4700
Sfmt
4700
E:\
FR\
FM\
30APR1.
SGM
30APR1
23059
Federal
Register
/
Vol.
68,
No.
83
/
Wednesday,
April
30,
2003
/
Rules
and
Regulations
TABLE
1.
 
SUBCHRONIC,
CHRONIC,
AND
OTHER
TOXICITY
 
Continued
Guideline
Number
Study
Type
Results
870.3200
Dermal
Toxicity
­
Rat
NOAEL
=
47
mg
ai/
kg/
day
(
males
and
females)
LOAEL
=
93
mg
ai/
kg/
day
(
males
and
females),
based
on
loss
of
muscle
coordination
and
increased
incidence
of
tremors.

870.7485
Metabolism
­
Rat
Very
little
of
the
administered
radioactive
dose
was
expired
as
14C­
CO2
(
0.028%
for
males
and
0.053%
for
females).
The
majority
(
about
70%)
of
the
administered
radioactivity
was
found
in
the
feces
with
about
20%
in
the
urine.
A
complication
of
this
study
is
that
males
were
administered
a
radioactive
dose
with
the
label
in
the
acid
position,
while
females
were
administered
a
radioactive
dose
with
the
label
in
the
alcohol
position
This
could
make
comparisons
between
males
and
females
difficult.
Despite
the
difference
in
14C­
labeling
position
in
the
bifenthrin
administered
to
males
and
females,
the
study
is
acceptable.
This
conclusion
is
based
on
the
fact
that
most
(>
90%)
of
the
radioactivity
was
eliminated
via
the
urine
and
feces,
with
no
significant
differences
between
the
sexes
in
this
respect.
Further,
there
were
no
significant
differences
between
dosage
groups
in
percentages
excreted.
This
suggests
that
most
of
the
compound
is
excreted
with
little
or
no
change,
or
in
a
form
incorporating
both
of
the
labeled
sites.
The
results
also
show
that
females
retained
slightly
more
radioactivity
in
their
bodies
(
particularly
in
adipose
tissue)
than
did
males,
particularly
at
the
high­
dose.
Labeling
of
the
material
given
to
the
females
was
in
the
biphenyl
group,
and,
given
a
splitting
of
the
molecule
between
the
two
labeling
sites,
this
would
have
tended
to
give
a
more
lipophilic
radiolabeled
residue.
Classification:
Acceptable­
Guideline
870.7485
Metabolism
­
Rat
Plasma
radioactivity
in
the
low­
dose
(
4
mg/
kg)
animals
after
dosing
slowly
rose,
indicating
a
slow
rate
of
absorption
from
the
gastrointestinal
tract.
The
half­
life
of
absorption
was
calculated
to
be
about
1.5
hours,
with
a
lag­
time
of
0.5
hours
following
first
order
kinetics.
Radioactivity
peaked
in
plasma
for
low­
dose
animals
in
4
hours.
The
elimination
of
14C­
bifenthrin
from
the
plasma
was
equally
slow,
with
significant
radioactivity
still
remaining
in
blood
at
72
hours.
Plasma
radioactivity
in
the
high­
dose
(
35
mg/
kg)
animals
appeared
to
follow
a
similar
course
as
seen
in
the
low­
dose
animals.
The
peak
radioactivity
for
the
high­
dose
group
appeared
to
be
somewhat
delayed,
peaking
at
about
6
hours.
Significant
radioactivity
still
remained
after
72
hours
in
the
high­
dose
animals.
Classification:
Acceptable­
Guideline
870.7485
Metabolism
­
Rat
The
major
metabolic
route
of
radiolabeled
bifenthrin
appeared
to
be
hydrolysis
of
the
ester
linkage
with
oxidation
of
the
resulting
alcohol
to
the
acid.
Protein
binding
of
radioactive
components
or
metabolites
appears
to
increase
with
time.
Classification:
Acceptable­
Guideline
870.7485
Metabolism
­
Rat
Fat
and
skin
half­
lives
were
the
longest
with
half­
lives
of
51
and
50
days,
respectively.
The
half­
lives
for
ovaries,
liver,
kidneys
and
sciatic
nerve
were
37.4,
19.0,
28.5,
and
42
days,
respectively.
Radioactive
components
were
measured
in
fat
at
numerous
time
intervals
before
and
after
daily
dosing.
The
major
component
in
fat
is
parent
compound
with
a
half­
life
of
47.5
days.
Other
unidentified
components
included
a
somewhat
polar
(
Rf
=
0.65)
compound
and
two
other
relatively
minor
components.
Classification:
Acceptable­
Guideline
870.7485
Metabolism
­
Rat
Within
7
days,
nearly
all
bifenthrin
and/
or
metabolites
were
excreted
in
either
urine
or
feces.
The
majority
of
radioactivity
was
excreted
in
the
feces
within
48
hours.
Tissues
that
retained
bifenthrin
and/
or
metabolites
beyond
7
days
included
fat
and
skin
in
males
and
females,
and
gonads
in
females.
Classification:
Unacceptable­
Guideline.
Although
the
number
of
animals/
group
in
this
study
was
3,
and
not
5/
sex/
group
as
recommended
by
guidelines,
and
a
quality
assurance
statement
was
lacking,
the
results
of
this
study
provide
useful
information.

VerDate
Jan<
31>
2003
12:
41
Apr
29,
2003
Jkt
200001
PO
00000
Frm
00035
Fmt
4700
Sfmt
4700
E:\
FR\
FM\
30APR1.
SGM
30APR1
23060
Federal
Register
/
Vol.
68,
No.
83
/
Wednesday,
April
30,
2003
/
Rules
and
Regulations
TABLE
1.
 
SUBCHRONIC,
CHRONIC,
AND
OTHER
TOXICITY
 
Continued
Guideline
Number
Study
Type
Results
870.7485
Metabolism
­
Rat
Results
showed
minimal
breakage
of
the
ester
linkage
of
the
parent
compound
in
the
material
eliminated
via
the
feces
in
the
period
of
0
 
48
hours
after
dosage,
when
most
of
the
administered
radioactivity
is
identifiable
as
coming
from
unmodified
parent
compound
However,
the
material
was
subsequently
eliminated,
although
a
relatively
small
proportion
of
the
administered
dose
appears
to
have
undergone
more
modification.
Since
a
greater
proportion
of
the
radioactivity
was
eliminated
via
the
feces
in
the
period
of
48
 
168
hours
in
the
form
of
2­
Methyl­
3­
phenylbenzyl
alcohol
and
2­
Methyl­
3­
phenylbenzoic
acid
than
the
parent
compound,
this
is
evidence
that
extensive
breakage
of
the
ester
linkage
does
occur,
either
in
the
material
retained
in
the
intestines
for
more
than
46
hours,
or
in
the
material
absorbed
and
subsequently
eliminated
via
the
feces.
Classification:
Unacceptable­
Guideline.
While
this
study
is
limited,
it
dose
provide
some
insight
into
the
incomplete
absorption
of
bifenthrin
from
the
intestine,
and
the
lack
of
modification
of
most
of
the
unabsorbed
material,
particularly
that
eliminated
via
the
feces
during
the
period
of
0
 
48
hours.
However,
the
metabolism
of
the
absorbed
compound
(
radioactivity
primarily
excreted
via
the
urine,
despite
differences
in
labeling)
is
less
clear.

870.7485
Metabolism
­
Rat
The
results
of
the
study
demonstrated
that
the
majority
of
radioactivity
excreted
in
the
feces
was
the
parent
compound
and
its
intact
hydroxylated
metabolites.
Much
of
the
radioactivity
excreted
in
urine
was
hydrolytic
and
hydrolytic/
oxidative
degradation
products
of
the
parent
compound.
Classification:
Unacceptable­
Guideline.

870.7600
Dermal
Penetration
­
Rats
For
animals
in
group
A,
means
of
4.6,
14.2,
12.8
and
14.7%
total
dose
were
recovered
from
the
skin
at
0,
4,
10
and
24
hours
post­
dose;
corresponding
percentages
in
the
wash
were
94.6,
80.8,
78.6
and
70%.
For
animals
in
group
B,
means
of
20.0,
37.9,
42.0
and
41.2%
remained
(
and
were
recovered
from)
the
skin
at
0,
4,
10
and
24
hours
post­
dose;
corresponding
percentages
in
the
wash
were
73.9,
50.6,
41.3
and
37.7%
respectively.
This
dermal
absorption
study
is
classified
as
acceptable.
However,
because
only
one
dose
was
used,
this
study,
by
itself,
does
not
satisfy
the
guideline
requirement
for
a
dermal
penetration
study
in
the
rat
for
technical
bifenthrin
(
FMC
54800).
However,
it
can
be
used,
in
conjunction
with
other
dermal
penetration
studies,
as
supporting
data
for
the
purposes
of
registration
and/
or
reregistration
of
products
containing
or
consisting
of
bifenthrin.

870.7600
Dermal
Penetration
­
Rats
Means
of
96.83,
84.75,
76.86
and
72.88%
of
the
radioactivity
were
recovered
in
the
skin
wash
at
0,
4,
10
and
24
hours
post
dosage,
respectively.
By
the
time
the
4
 
hour
postdose
and
later
skin
samples
were
collected
the
emulsifying
solvents
had
evaporated.
Means
of
4.04,
12.00,
16.55
and
19.44%
total
dose
were
recovered
from
the
washed
skin
of
the
application
site
at
0,
4,
10
and
24
hours
respectively;
corresponding
mean
percentages
recovered
from
the
carcass
were
0.09,
0.87,
0.85
and
1.67%.
Mean
percentages
recovered
in
urine
and
feces
were
0,
0.14,
0.43
and
3.23%.
This
dermal
absorption
study
is
classified
as
acceptable.
However,
because
only
one
dose
was
used,
this
study,
by
itself,
does
not
satisfy
the
guideline
requirement
for
a
dermal
penetration
study
in
the
rat
for
technical
bifenthrin
(
FMC
54800).
However,
it
can
be
used,
in
conjunction
with
other
dermal
penetration
studies,
as
supporting
data
for
the
purposes
of
registration
and/
or
reregistration
of
products
containing
or
consisting
of
bifenthrin.

870.7600
Dermal
Penetration
­
Rats
In
general,
only
very
small
amounts
of
radioactivity
were
present
in
blood,
excrement,
and
carcasses,
with
almost
all
(
approximately
99%)
of
the
absorbed
radioactivity
localized
in
skin
at
the
application
site,
and
in
the
skin
adjacent
to
the
application
site.
Average
percentages
of
FMC
54800
dosages
absorbed
at
10
hours
were
55.8%,
54.1%,
and
37.5%
for
the
49.2,
514
and
5253
µ
g/
rat
groups
respectively.
Corresponding
percentages
for
the
3
groups
at
the
0.5
hour
sacrifice
were
54.6%,
56.4%,
and
52.5%,
so
the
percentage
absorption
of
FMC
54800
did
not
seem
to
depend
on
time­
to­
sacrifice.
At
10
hours
and
the
lowest
dose
level,
the
percentages
present
were
as
follows:
excreta
<
0.44%;
carcass:
<
1.8%;
skin
at
application
site:
50.3%;
skin
adjacent
to
application
site:
5.5%.
At
10
hours
and
the
highest
dose
level,
the
percentages
of
total
dose
present
were
as
follows:
excreta:
0.07%;
carcass:
0.5%;
skin
at
application
site:
34.6%;
skin
adjacent
to
application
site:
2.7%.
Classification:
This
dermal
absorption
study
is
classified
as
acceptable.
However,
by
itself,
does
not
satisfy
the
guideline
requirement
for
a
dermal
penetration
study
in
the
rat
for
technical
bifenthrin
(
FMC
54800).
However,
it
can
be
used,
in
conjunction
with
other
dermal
penetration
studies,
as
supporting
data
for
the
purposes
of
registration
and/
or
reregistration
of
products
containing
or
consisting
of
bifenthrin.

VerDate
Jan<
31>
2003
12:
41
Apr
29,
2003
Jkt
200001
PO
00000
Frm
00036
Fmt
4700
Sfmt
4700
E:\
FR\
FM\
30APR1.
SGM
30APR1
23061
Federal
Register
/
Vol.
68,
No.
83
/
Wednesday,
April
30,
2003
/
Rules
and
Regulations
TABLE
1.
 
SUBCHRONIC,
CHRONIC,
AND
OTHER
TOXICITY
 
Continued
Guideline
Number
Study
Type
Results
870.7600
Dermal
Penetration
­
Rats
The
report
states
that
at
24
hours
postdose,
5.11%
of
the
dose
was
absorbed
(
application
site
skin
+
carcass
+
urine
+
feces)
in
this
second
trial.
However,
it
is
noted
that
there
was
poor
recovery
(
68%
of
the
total
dose)
from
one
of
the
rats
(
C32545)
sacrificed
at
24
hours
in
the
second
trial;
disregarding
the
findings
from
this
one
animal
then
the
mean
value
of
the
dose
that
was
absorbed
was
5.88%,
and
this
can
be
taken
as
a
reasonable
estimate
of
the
dermal
absorption
at
this
dose
level.
This
dermal
absorption
study
is
classified
as
acceptable.
However,
because
only
one
dose
was
used,
this
study,
by
itself,
does
not
satisfy
the
guideline
requirement
for
a
dermal
penetration
study
in
the
rat
for
technical
bifenthrin
(
FMC
54800).
However,
it
can
be
used,
in
conjunction
with
other
dermal
penetration
studies,
as
supporting
data
for
the
purposes
of
registration
and/
or
reregistration
of
products
containing
or
consisting
of
bifenthrin.

B.
Toxicological
Endpoints
The
dose
at
which
no
adverse
effects
are
observed
(
the
NOAEL)
from
the
toxicology
study
identified
as
appropriate
for
use
in
risk
assessment
is
used
to
estimate
the
toxicological
level
of
concern
(
LOC).
However,
the
lowest
dose
at
which
adverse
effects
of
concern
are
identified
(
the
LOAEL)
is
sometimes
used
for
risk
assessment
if
no
NOAEL
was
achieved
in
the
toxicology
study
selected.
An
uncertainty
factor
(
UF)
is
applied
to
reflect
uncertainties
inherent
in
the
extrapolation
from
laboratory
animal
data
to
humans
and
in
the
variations
in
sensitivity
among
members
of
the
human
population
as
well
as
other
unknowns.
An
UF
of
100
is
routinely
used,
10X
to
account
for
interspecies
differences
and
10X
for
intraspecies
differences.
In
this
case,
EPA
has
determined
that
an
additional
10X
data
base
uncertainty
factor
(
UFDB)
is
needed
to
account
for
the
lack
of
a
developmental
neurotoxicity
(
DNT)
study
when
assessing
acute
(
single
dose)
exposure
scenarios.
EPA
has
further
determined
that
for
repeated
dose
exposure
scenarios
(
i.
e.,
chronic
dietary;
short­
and
intermediate­
term
incidental
oral;
and
short­,
intermediate­,
and
longterm
dermal
and
inhalation
scenarios)
a
3X
UFDB
is
adequate
to
account
for
the
lack
of
the
DNT
study.
The
factors
which
EPA
considered
in
making
these
determinations
are
discussed
in
detail
below
in
Unit
III.
D.
3.
For
dietary
risk
assessment
(
other
than
cancer)
the
Agency
uses
the
UF
to
calculate
an
acute
or
chronic
reference
dose
(
acute
RfD
or
chronic
RfD)
where
the
RfD
is
equal
to
the
NOAEL
divided
by
the
appropriate
UF
(
RfD
=
NOAEL/
UF).
Where
an
additional
safety
factor
(
SF)
is
retained
due
to
concerns
unique
to
the
FQPA,
this
additional
factor
is
applied
to
the
RfD
by
dividing
the
RfD
by
such
additional
factor.
The
acute
or
chronic
Population
Adjusted
Dose
(
aPAD
or
cPAD)
is
a
modification
of
the
RfD
to
accommodate
this
type
of
FQPA
SF.
For
non­
dietary
risk
assessments
(
other
than
cancer)
the
UF
is
used
to
determine
the
LOC.
For
example,
when
100
is
the
appropriate
UF
(
10X
to
account
for
interspecies
differences
and
10X
for
intraspecies
differences)
the
LOC
is
100.
In
this
case,
since
300
is
the
appropriate
UF
for
repeated
dose
exposure
scenarios
(
10X
to
account
for
interspecies
differences;
10X
for
intraspecies
differences
and
3X
for
data
base
uncertainty)
the
LOC
is
300.
To
estimate
risk,
a
ratio
of
the
NOAEL
to
exposures
(
margin
of
exposure
(
MOE)
=
NOAEL/
exposure)
is
calculated
and
compared
to
the
LOC.
The
linear
default
risk
methodology
(
Q*)
is
the
primary
method
currently
used
by
the
Agency
to
quantify
carcinogenic
risk.
The
Q*
approach
assumes
that
any
amount
of
exposure
will
lead
to
some
degree
of
cancer
risk.
A
Q*
is
calculated
and
used
to
estimate
risk
which
represents
a
probability
of
occurrence
of
additional
cancer
cases
(
e.
g.,
risk
is
expressed
as
1
x
10­
6
or
one
in
a
million).
Under
certain
specific
circumstances,
MOE
calculations
will
be
used
for
the
carcinogenic
risk
assessment.
In
this
non­
linear
approach,
a
``
point
of
departure''
is
identified
below
which
carcinogenic
effects
are
not
expected.
The
point
of
departure
is
typically
a
NOAEL
based
on
an
endpoint
related
to
cancer
effects
though
it
may
be
a
different
value
derived
from
the
dose
response
curve.
To
estimate
risk,
a
ratio
of
the
point
of
departure
to
exposure
(
MOEcancer
=
point
of
departure/
exposures)
is
calculated.
A
summary
of
the
toxicological
endpoints
for
bifenthrin
used
for
human
risk
assessment
is
shown
in
Table
2
of
this
unit:

TABLE
2.
 
SUMMARY
OF
TOXICOLOGICAL
DOSE
AND
ENDPOINTS
FOR
BIFENTHRIN
FOR
USE
IN
HUMAN
RISK
ASSESSMENT
Exposure
Scenario
Dose
Used
in
Risk
Assessment
UF
FQPA
SF*
and
Level
of
Concern
for
Risk
Assessment
Study
and
Toxicological
Effects
Acute
Dietary
(
General
population
including
infants
and
children)
NOAEL
=
32.8
mg
ai/
kg
UF
=
1,000
Acute
RfD
=
0.033
mg/
kg/
day
FQPA
SF
=
1X
aPAD
=
acute
RfD
÷
FQPA
SF
=
0.033
mg/
kg/
day
Acute
Neurotoxicity
Study
in
Rats
LOAEL
=
70.3
mg/
kg/
day
based
on
observations
of
mortality
(
females
only),
clinical
and
functional
operational
battery
(
FOB)
findings
and
differences
in
motor
activity.

Chronic
Dietary
(
All
populations)
NOAEL
=
1.3
mg/
kg/
day
UF
=
300
Chronic
RfD
=
0.004
mg/
kg/
day
FQPA
SF
=
1X
cPAD
=
chronic
RfD
÷
FQPA
SF
=
0.004
mg/
kg/
day
1
 
Year
Oral
Study
in
Dogs
LOAEL
=
2.7
mg/
kg/
day
based
on
observations
of
increased
incidence
of
tremors
in
both
sexes.

VerDate
Jan<
31>
2003
12:
41
Apr
29,
2003
Jkt
200001
PO
00000
Frm
00037
Fmt
4700
Sfmt
4700
E:\
FR\
FM\
30APR1.
SGM
30APR1
23062
Federal
Register
/
Vol.
68,
No.
83
/
Wednesday,
April
30,
2003
/
Rules
and
Regulations
TABLE
2.
 
SUMMARY
OF
TOXICOLOGICAL
DOSE
AND
ENDPOINTS
FOR
BIFENTHRIN
FOR
USE
IN
HUMAN
RISK
ASSESSMENT
 
Continued
Exposure
Scenario
Dose
Used
in
Risk
Assessment
UF
FQPA
SF*
and
Level
of
Concern
for
Risk
Assessment
Study
and
Toxicological
Effects
Incidental
Oral
Short­
Term
(
1
 
30
Days)
Residential
Only
NOAEL
=
2.21
mg
ai/
kg/
day
UF
=
300
FQPA
SF
=
1X
LOC
for
MOE
=
300
90
 
Day
Oral
Study
in
Dogs
LOAEL
=
4.42
mg
ai/
kg/
day
based
on
observations
of
increased
incidence
of
tremors
in
both
sexes.

Incidental
Oral
Intermediate­
Term
(
1
 
6
Months)
Residential
Only
NOAEL
=
2.21
mg
ai/
kg/
day
UF
=
300
FQPA
SF
=
1X
LOC
for
MOE
=
300
90
 
Day
Oral
Study
in
Dogs
LOAEL
=
4.42
mg
ai/
kg/
day
based
on
observations
of
increased
incidence
of
tremors
in
both
sexes.

Short­
Term
Dermal
(
1
to
30
days)
(
Residential)
dermal
study
NOAEL
=
47
mg/
kg/
day
FQPA
SF
=
1X
LOC
for
MOE
=
300
(
Residential)
21
 
Day
Dermal
Study
in
Rats
LOAEL
=
93
mg/
kg/
day
based
on
observations
of
clinical
signs
(
staggered
gait
and
exaggerated
hindlimb
flexion).

Intermediate­
Term
Dermal
(
1
to
6
months)
(
Residential)
dermal
study
NOAEL
=
47
mg/
kg/
day
FQPA
SF
=
1X
LOC
for
MOE
=
300
(
Residential)
21
 
Day
Dermal
Study
in
Rats
LOAEL
=
93
mg/
kg/
day
based
on
observations
of
clinical
signs
(
staggered
gait
and
exaggerated
hindlimb
flexion).

Long­
Term
Dermal
(
several
months
to
lifetime)
(
Residential)
dermal
study
NOAEL
=
47
mg/
kg/
day
FQPA
SF
=
1X
LOC
for
MOE
=
300
(
Residential)
21
 
Day
Dermal
Study
in
Rats
LOAEL
=
93
mg/
kg/
day
based
on
observations
of
clinical
signs
(
staggered
gait
and
exaggerated
hindlimb
flexion).

Short­
Term
Inhalation
(
1
to
30
days)
(
Residential)
oral
study
NOAEL
=
2.21
mg/
kg/
day
FQPA
SF
=
1X
LOC
for
MOE
=
300
(
Residential)
90
 
Day
Oral
Study
in
Dogs
LOAEL
=
4.42
mg/
kg/
day
based
on
observations
of
increased
incidence
of
tremors
in
both
sexes.

Intermediate­
Term
Inhalation
(
1
to
6
months)
(
Residential)
oral
study
NOAEL
=
2.21
mg/
kg/
day
FQPA
SF
=
1X
LOC
for
MOE
=
300
(
Residential)
90
 
Day
Oral
Study
in
Dogs
LOAEL
=
4.42
mg/
kg/
day
based
on
observations
of
increased
incidence
of
tremors
in
both
sexes.

Long­
Term
Inhalation
(
several
months
to
lifetime)
(
Residential)
oral
study
NOAEL
=
1.3
mg/
kg/
day
FQPA
SF
=
1X
LOC
for
MOE
=
300
(
Residential)
1
 
Year
Oral
Study
in
Dogs
LOAEL
=
2.7
mg/
kg/
day
based
on
observations
of
increased
incidence
of
tremors
in
both
sexes.

Cancer
(
oral,
dermal,
inhalation)
EPA's
Carcinogenicity
Peer
Review
Committee
(
CPRC)
has
characterized
bifenthrin
as
a
Category
C
(
possible
human)
carcinogen,
primarily
on
the
basis
of
the
mouse
carcinogenicity
study
in
which
the
high­
dose
males
(
81.3
mg/
kg/
day)
showed
a
highly
significant
increased
incidence
of
urinary
bladder
tumors.
Other
findings
in
the
mouse
study
included
a
dose­
related
trend
of
increased
combined
incidences
of
adenoma
and
adenocarcinoma
of
the
liver
(
males
only),
and
increased
incidences
of
bronchioalveolar
adenomas
and
adenocarcinomas
of
the
lung
in
females
at
some,
but
not
all,
doses
relative
to
their
controls.
The
Agency
did
not
recommend
assignment
of
a
Q1*
but
has
determined
that
the
reference
dose
(
RfD)
approach
should
be
used
for
quantification
of
human
risk.

*
The
reference
to
the
FQPA
SF
refers
to
any
additional
SF
retained
due
to
concerns
unique
to
the
FQPA.

C.
Exposure
Assessment
1.
Dietary
exposure
from
food
and
feed
uses.
Tolerances
have
been
established
(
40
CFR
180.442)
for
the
residues
of
bifenthrin
in
or
on
a
variety
of
raw
agricultural
commodities.
Tolerances
have
been
established
on
plant
commodities
ranging
from
0.05
ppm
for
corn
grain,
peas,
beans
and
eggplant
to
10
ppm
for
dried
hops
and
on
animal
commodities
ranging
from
0.01
ppm
for
meat
byproducts
to
1.0
ppm
for
milk
fat
and
fat
of
cattle,
goats,
hogs,
horses,
and
sheep.
Risk
assessments
were
conducted
by
EPA
to
assess
dietary
exposures
from
bifenthrin
in
food
as
follows:
i.
Acute
exposure.
Acute
dietary
risk
assessments
are
performed
for
a
fooduse
pesticide
if
a
toxicological
study
has
indicated
the
possibility
of
an
effect
of
concern
occurring
as
a
result
of
a
one
day
or
single
exposure.
The
Dietary
Exposure
Evaluation
Model
(
DEEM
 
)
analysis
evaluated
the
individual
food
consumption
as
reported
by
respondents
in
the
USDA
1989
 
1992
nationwide
Continuing
Surveys
of
Food
Intake
by
Individuals
(
CSFII)
and
accumulated
exposure
to
the
chemical
for
each
commodity.
The
following
assumptions
were
made
for
the
acute
exposure
assessments:
A
probabilistic
dietary
exposure
assessment
was
conducted
for
the
general
U.
S.
population
and
all
population
subgroups,
including
infants
and
children.
The
highly
refined
assessment
incorporated
the
most
recent
USDA
Pesticide
Data
Program
(
PDP)
monitoring
data,
field
trial
data
and
processing
factor
data
(
for
grapes
and
pending
uses).
It
assumed
100%
crop
treated
for
the
new
and
existing
uses.
ii.
Chronic
exposure.
In
conducting
this
chronic
dietary
risk
assessment
the
DEEM
 
analysis
evaluated
the
VerDate
Jan<
31>
2003
12:
41
Apr
29,
2003
Jkt
200001
PO
00000
Frm
00038
Fmt
4700
Sfmt
4700
E:\
FR\
FM\
30APR1.
SGM
30APR1
23063
Federal
Register
/
Vol.
68,
No.
83
/
Wednesday,
April
30,
2003
/
Rules
and
Regulations
individual
food
consumption
as
reported
by
respondents
in
the
USDA
1989
 
1992
nationwide
CSFII
and
accumulated
exposure
to
the
chemical
for
each
commodity.
The
following
assumptions
were
made
for
the
chronic
exposure
assessments:
A
highly
refined
chronic
exposure
assessment
was
conducted
which
incorporated
the
most
recent
PDP
monitoring
data,
field
trial
data
and
processing
factor
data
(
for
grapes
and
pending
uses).
It
assumed
100%
crop
treated
for
the
new
and
existing
uses.
iii.
Cancer.
Bifenthrin
has
been
classified
as
a
Category
C
(
possible
human)
carcinogen.
The
Agency
has
determined
that
the
reference
dose
(
RfD)
approach
should
be
used
for
quantification
of
human
risk.
For
further
discussion
of
the
weight­
of­
the­
evidence
considered
by
EPA
in
making
this
determination,
see
the
proposed
rule
for
Bifenthrin
tolerances
(
59
FR
9167,
February
25,
1994)
(
FRL
 
4756
 
1).
Under
this
approach,
chronic
dietary
exposures
that
are
less
than
the
RfD
(
or
cPAD)
are
assumed
to
be
protective
for
cancer
dietary
exposure
as
well.
Therefore,
a
separate
cancer
dietary
risk
assessment
was
not
conducted.
iv.
Anticipated
residue
and
percent
crop
treated
(
PCT)
information.
Section
408(
b)(
2)(
E)
of
the
FFDCA
authorizes
EPA
to
use
available
data
and
information
on
the
anticipated
residue
levels
of
pesticide
residues
in
food
and
the
actual
levels
of
pesticide
chemicals
that
have
been
measured
in
food.
If
EPA
relies
on
such
information,
EPA
must
require
that
data
be
provided
5
years
after
the
tolerance
is
established,
modified,
or
left
in
effect,
demonstrating
that
the
levels
in
food
are
not
above
the
levels
anticipated.
Following
the
initial
data
submission,
EPA
is
authorized
to
require
similar
data
on
a
time
frame
it
deems
appropriate.
As
required
by
section
408(
b)(
2)(
E)
of
the
FFDCA,
EPA
will
issue
a
data
call­
in
for
information
relating
to
anticipated
residues
to
be
submitted
no
later
than
5
years
from
the
date
of
issuance
of
this
tolerance.
Section
408(
b)(
2)(
F)
of
the
FFDCA
states
that
the
Agency
may
use
data
on
the
actual
percent
of
food
treated
for
assessing
chronic
dietary
risk
only
if
the
Agency
can
make
the
following
findings:
Condition
1,
that
the
data
used
are
reliable
and
provide
a
valid
basis
to
show
what
percentage
of
the
food
derived
from
such
crop
is
likely
to
contain
such
pesticide
residue;
Condition
2,
that
the
exposure
estimate
does
not
underestimate
exposure
for
any
significant
subpopulation
group;
and
Condition
3,
if
data
are
available
on
pesticide
use
and
food
consumption
in
a
particular
area,
the
exposure
estimate
does
not
understate
exposure
for
the
population
in
such
area.
In
addition,
the
Agency
must
provide
for
periodic
evaluation
of
any
estimates
used.
To
provide
for
the
periodic
evaluation
of
the
estimate
of
PCT
as
required
by
section
408(
b)(
2)(
F)
of
the
FFDCA,
EPA
may
require
registrants
to
submit
data
on
PCT.
The
Agency
did
not
use
percent
crop
treated
information
for
assessing
dietary
risk
from
bifenthrin.
2.
Dietary
exposure
from
drinking
water.
The
Agency
lacks
sufficient
monitoring
exposure
data
to
complete
a
comprehensive
dietary
exposure
analysis
and
risk
assessment
for
bifenthrin
in
drinking
water.
Because
the
Agency
does
not
have
comprehensive
monitoring
data,
drinking
water
concentration
estimates
are
made
by
reliance
on
simulation
or
modeling
taking
into
account
data
on
the
physical
characteristics
of
bifenthrin.
The
Agency
uses
the
FQPA
Index
Reservoir
Screening
Tool
(
FIRST)
or
the
Pesticide
Root
Zone/
Exposure
Analysis
Modeling
System
(
PRZM/
EXAMS),
to
produce
estimates
of
pesticide
concentrations
in
an
index
reservoir.
The
SCI­
GROW
model
is
used
to
predict
pesticide
concentrations
in
shallow
groundwater.
For
a
screening­
level
assessment
for
surface
water
EPA
will
use
FIRST,
a
tier
1
model,
before
using
PRZM/
EXAMS,
a
tier
2
model.
The
FIRST
model
is
a
subset
of
the
PRZM/
EXAMS
model
that
uses
a
specific
highend
runoff
scenario
for
pesticides.
While
both
FIRST
and
PRZM/
EXAMS
incorporate
an
index
reservoir
environment,
the
PRZM/
EXAMS
model
includes
a
percent
crop
area
factor
as
an
adjustment
to
account
for
the
maximum
percent
crop
coverage
within
a
watershed
or
drainage
basin.
None
of
these
models
include
consideration
of
the
impact
processing
(
mixing,
dilution,
or
treatment)
of
raw
water
for
distribution
as
drinking
water
would
likely
have
on
the
removal
of
pesticides
from
the
source
water.
The
primary
use
of
these
models
by
the
Agency
at
this
stage
is
to
provide
a
coarse
screen
for
sorting
out
pesticides
for
which
it
is
highly
unlikely
that
drinking
water
concentrations
would
ever
exceed
human
health
levels
of
concern.
Since
the
models
used
are
considered
to
be
screening
tools
in
the
risk
assessment
process,
the
Agency
does
not
use
estimated
environmental
concentrations
(
EECs)
from
these
models
to
quantify
drinking
water
exposure
and
risk
as
a
%
RfD
or
%
PAD.
Instead,
drinking
water
levels
of
comparison
(
DWLOCs)
are
calculated
and
used
as
a
point
of
comparison
against
the
model
estimates
of
a
pesticide's
concentration
in
water.
DWLOCs
are
theoretical
upper
limits
on
a
pesticide's
concentration
in
drinking
water
in
light
of
total
aggregate
exposure
to
a
pesticide
in
food,
and
from
residential
uses.
Since
DWLOCs
address
total
aggregate
exposure
to
bifenthrin
they
are
further
discussed
in
the
aggregate
risk
sections
in
Unit
III.
E.
Based
on
the
FIRST
and
SCI­
GROW
models
the
estimated
environmental
concentrations
(
EECs)
of
bifenthrin
for
acute
exposures
are
estimated
to
be
0.1
parts
per
billion
(
ppb)
for
surface
water
and
0.006
ppb
for
ground
water.
The
EECs
for
chronic
exposures
are
estimated
to
be
0.1
ppb
for
surface
water
and
0.006
ppb
for
ground
water.
3.
From
non­
dietary
exposure.
The
term
``
residential
exposure''
is
used
in
this
document
to
refer
to
nonoccupational
non­
dietary
exposure
(
e.
g.,
for
lawn
and
garden
pest
control,
indoor
pest
control,
termiticides,
and
flea
and
tick
control
on
pets).
Bifenthrin
is
currently
registered
for
use
on
the
following
residential
nondietary
sites:
ornamental
gardens,
lawns,
turf,
and
general
insect
control
in,
around
and
on
buildings,
structures,
and
immediate
surroundings.
There
are
also
uses
for
spot
treatments
and
crack
and
crevice
treatments
for
insects
in,
on,
and
around
homes,
buildings,
and
other
structures
and
for
subsoil
treatment
around
structures
for
control
of
termites
(
termiticide
use).
The
risk
assessment
was
conducted
using
the
following
residential
exposure
assumptions:
Adults
and
children
are
potentially
exposed
to
bifenthrin
residues
after
application
of
bifenthrin
products
in
residential
settings.
Short­
and
intermediate­
term
post­
application
dermal
exposures
for
adults,
and
short­
and
intermediate­
term
post­
application
dermal
and
incidental
oral
exposures
for
children
are
anticipated.
Risk
estimates
were
generated
for
potential
contact
with
lawn,
soil,
and
treated
indoor
surfaces
using
EPA's
Draft
Standard
Operating
Procedures
for
Residential
Exposure
Assessment;
and
for
the
lawn
exposure
scenarios,
dissipation
data
from
a
chemical
specific
turf
transferable
residue
(
TTR)
study.
Indoor
surface
residues
in
homes
were
based
on
crack
and
crevice
data
collected
for
bifenthrin
and
another
insecticide,
malathion.
These
estimates
are
considered
conservative
screening
level
estimates,
since
the
study
data
were
adjusted
to
reflect
maximum
application
rates.
4.
Cumulative
effects
from
substances
with
a
common
mechanism
of
toxicity.
Section
408(
b)(
2)(
D)(
v)
of
the
FFDCA
VerDate
Jan<
31>
2003
12:
41
Apr
29,
2003
Jkt
200001
PO
00000
Frm
00039
Fmt
4700
Sfmt
4700
E:\
FR\
FM\
30APR1.
SGM
30APR1
23064
Federal
Register
/
Vol.
68,
No.
83
/
Wednesday,
April
30,
2003
/
Rules
and
Regulations
requires
that,
when
considering
whether
to
establish,
modify,
or
revoke
a
tolerance,
the
Agency
consider
``
available
information''
concerning
the
cumulative
effects
of
a
particular
pesticide's
residues
and
``
other
substances
that
have
a
common
mechanism
of
toxicity.''
EPA
does
not
have,
at
this
time,
available
data
to
determine
whether
bifenthrin
has
a
common
mechanism
of
toxicity
with
other
substances.
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
as
to
bifenthrin
and
any
other
substances
and
bifenthrin
does
not
appear
to
produce
a
toxic
metabolite
produced
by
other
substances.
For
the
purposes
of
this
tolerance
action,
therefore,
EPA
has
not
assumed
that
bifenthrin
has
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
Web
site
at
http://
www.
epa.
gov/
pesticides/
cumulative/.

D.
Safety
Factor
for
Infants
and
Children
1.
In
general.
Section
408
of
the
FFDCA
provides
that
EPA
shall
apply
an
additional
tenfold
margin
of
safety
for
infants
and
children
in
the
case
of
threshold
effects
to
account
for
prenatal
and
postnatal
toxicity
and
the
completeness
of
the
data
base
on
toxicity
and
exposure
unless
EPA
determines
that
a
different
margin
of
safety
will
be
safe
for
infants
and
children.
Margins
of
safety
are
incorporated
into
EPA
risk
assessments
either
directly
through
use
of
a
MOE
analysis
or
through
using
uncertainty
(
safety)
factors
in
calculating
a
dose
level
that
poses
no
appreciable
risk
to
humans.
2.
Prenatal
and
postnatal
sensitivity.
EPA
concluded
that
there
is
not
a
concern
for
pre­
and/
or
postnatal
toxicity
resulting
from
exposure
to
bifenthrin.
There
was
no
quantitative
or
qualitative
evidence
of
increased
susceptibility
of
rat
or
rabbit
fetuses
to
in
utero
exposure
to
Bifenthrin
in
developmental
toxicity
studies
and
no
quantitative
or
qualitative
evidence
of
increased
susceptibility
of
neonates
(
as
compared
to
adults)
to
bifenthrin
in
a
2­
generation
reproduction
study
in
rats.
In
addition,
there
are
no
concerns
or
residual
uncertainties
for
pre
and/
or
post­
natal
toxicity
following
exposure
to
Bifenthrin.
3.
Conclusion.
No
special
FQPA
safety
factor
is
needed
based
on
concerns
for
pre­
and/
or
postnatal
toxicity
to
bifenthrin.
However,
EPA
has
concluded
that
in
light
of
the
lack
of
the
DNT
study
there
is
no
reliable
basis
for
removing
the
additional
FQPA
10X
safety
factor
when
assessing
acute
(
single
dose)
exposure
scenarios.
The
following
points
were
considered
in
this
determination:
i.
It
is
assumed
that
the
DNT
study
will
be
conducted
at
dose
levels
similar
to
those
used
in
the
rat
reproduction
study
with
Bifenthrin
wherein
the
offspring
NOAEL
was
5.0
mg/
kg/
day,
the
highest
dose
tested
(
no
effects
were
observed
in
offspring
at
this
dose);
but
that
the
DNT
study
would
not
be
conducted
at
dose
levels
higher
than
10
mg/
kg/
day
since
a
range­
finding
study
indicates
excessive
fetotoxicity
occurred
at
this
dose
(
all
pups
from
2
of
the
4
litters
at
10
mg/
kg/
day
died
within
14
days
of
birth).
ii.
The
DNT
study
may
impact
the
currently
selected
acute
regulatory
dose
since
the
NOAEL
used
to
establish
the
acute
Reference
dose
for
dietary
risk
assessment
is
33
mg/
kg/
day,
a
level
which
is
more
than
5
 
fold
higher
than
the
offspring
NOAEL
in
the
rat
reproduction
study
of
5.0
mg/
kg/
day
(
a
level
which
is
similar
to
dose
levels
likely
to
be
used
in
the
DNT
study).
EPA
has
further
determined
that
for
repeated
dose
exposure
scenarios
a
3X
UFDB
is
adequate
to
account
for
the
lack
of
the
DNT
study.
Repeated
dose
exposure
scenarios
include
chronic
dietary
exposure;
short­
term
(
repeated
exposure
up
to
30
days)
and
intermediate­
term
(
repeated
exposure
from
1
to
6
months)
incidental
oral
exposure;
and
short­
term,
intermediateterm
and
long­
term
(
several
months
to
lifetime)
dermal
and
inhalation
exposure
scenarios.
EPA's
determination
that
a
3X
UFDB
is
adequate
for
repeated
dose
exposure
scenarios
is
based
on
the
following
considerations:
a.
As
stated
above,
the
DNT
study
will
likely
be
conducted
at
dose
levels
similar
to
the
rat
reproduction
study.
b.
The
results
of
the
DNT
study
are
not
expected
to
impact
the
current
regulatory
doses
selected
for
repeated
exposure
scenarios
since
the
NOAELs
used
for
these
risk
assessment
endpoints
(
e.
g.,
1.3
mg/
kg/
day
from
the
chronic
dog
study
for
chronic
RfD)
are
approximately
4
 
fold
lower
than
the
offspring
NOAEL
(
5.0
mg/
kg/
day)
in
the
rat
reproduction
study
conducted
with
Bifenthrin.
Although
the
results
of
the
DNT
are
not
expected
to
impact
the
current
regulatory
dose
given
the
4
 
fold
difference
observed
in
the
rat
and
dog
studies,
EPA
does
not
have
sufficient
reliable
data
to
apply
no
additional
FQPA
safety
factor.
Rather,
EPA
believes
that
the
4X
difference
between
the
offspring
NOAEL
in
the
rat
reproduction
study
and
the
NOAELs
used
for
risk
assessment
endpoints
provides
reliable
data
supporting
a
3X
UF
for
repeated
dose
exposure
scenarios.
The
use
of
a
3X
provides
roughly
a
10
 
fold
difference
between
the
NOAEL
associated
with
the
identified
effects
in
the
rat
necessitating
the
DNT
study
and
the
NOAELs
used
for
setting
regulatory
doses.
Therefore,
a
UFDB
of
3X
will
be
applied
as
a
FQPA
safety
factor
to
repeated
dose
exposure
scenarios
to
account
for
the
lack
of
the
DNT
study
with
Bifenthrin.

E.
Aggregate
Risks
and
Determination
of
Safety
To
estimate
total
aggregate
exposure
to
a
pesticide
from
food,
drinking
water,
and
residential
uses,
the
Agency
calculates
DWLOCs
which
are
used
as
a
point
of
comparison
against
the
model
estimates
of
a
pesticide's
concentration
in
water
(
EECs).
DWLOC
values
are
not
regulatory
standards
for
drinking
water.
DWLOCs
are
theoretical
upper
limits
on
a
pesticide's
concentration
in
drinking
water
in
light
of
total
aggregate
exposure
to
a
pesticide
in
food
and
residential
uses.
In
calculating
a
DWLOC,
the
Agency
determines
how
much
of
the
acceptable
exposure
(
i.
e.,
the
PAD)
is
available
for
exposure
through
drinking
water
[
e.
g.,
allowable
chronic
water
exposure
(
mg/
kg/
day)
=
cPAD
­
(
average
food
+
residential
exposure)].
This
allowable
exposure
through
drinking
water
is
used
to
calculate
a
DWLOC.
A
DWLOC
will
vary
depending
on
the
toxic
endpoint,
drinking
water
consumption,
and
body
weights.
Default
body
weights
and
consumption
values
as
used
by
the
USEPA
are
used
to
calculate
DWLOCs:
2
liter
(
L)/
70
kg
(
adult
male),
2L/
60
kg
(
adult
female),
and
1L/
10
kg
(
child).
Actual
body
weights
and
drinking
water
consumption
values
vary
on
an
individual
basis.
This
variation
will
be
taken
into
account
in
more
refined
screening­
level
and
quantitative
drinking
water
exposure
assessments.
Different
populations
will
have
different
DWLOCs.
Generally,
a
DWLOC
is
calculated
for
each
type
of
risk
assessment
used:
Acute,
short­
term,
intermediate­
term,
chronic,
and
cancer.
When
EECs
for
surface
water
and
ground
water
are
less
than
the
VerDate
Jan<
31>
2003
12:
41
Apr
29,
2003
Jkt
200001
PO
00000
Frm
00040
Fmt
4700
Sfmt
4700
E:\
FR\
FM\
30APR1.
SGM
30APR1
23065
Federal
Register
/
Vol.
68,
No.
83
/
Wednesday,
April
30,
2003
/
Rules
and
Regulations
calculated
DWLOCs,
EPA
concludes
with
reasonable
certainty
that
exposures
to
the
pesticide
in
drinking
water
(
when
considered
along
with
other
sources
of
exposure
for
which
EPA
has
reliable
data)
would
not
result
in
unacceptable
levels
of
aggregate
human
health
risk
at
this
time.
Because
EPA
considers
the
aggregate
risk
resulting
from
multiple
exposure
pathways
associated
with
a
pesticide's
uses,
levels
of
comparison
in
drinking
water
may
vary
as
those
uses
change.
If
new
uses
are
added
in
the
future,
EPA
will
reassess
the
potential
impacts
of
residues
of
the
pesticide
in
drinking
water
as
a
part
of
the
aggregate
risk
assessment
process.
1.
Acute
risk.
Using
the
exposure
assumptions
discussed
in
this
unit
for
acute
exposure,
the
acute
dietary
exposure
from
food
to
bifenthrin
will
occupy
32%
of
the
aPAD
for
the
U.
S.
population,
19%
of
the
aPAD
for
females
13
to
50
years
old,
52%
of
the
aPAD
for
infants
less
than
1
year
old
and
38%
of
the
aPAD
for
children
1
to
6
years
old.
In
addition,
there
is
potential
for
acute
dietary
exposure
to
bifenthrin
in
drinking
water.
After
calculating
DWLOCs
and
comparing
them
to
the
EECs
for
surface
and
ground
water,
EPA
does
not
expect
the
aggregate
exposure
to
exceed
100%
of
the
aPAD,
as
shown
in
Table
3
of
this
unit:

TABLE
3.
 
AGGREGATE
RISK
ASSESSMENT
FOR
ACUTE
EXPOSURE
TO
BIFENTHRIN
Population
Subgroup
aPAD
(
mg/
kg)
%
aPAD
(
Food)
Surface
Water
EEC
(
ppb)
Ground
Water
EEC
(
ppb)
Acute
DWLOC
(
ppb)

U.
S.
population
0.033
32
0.1
0.006
780
All
Infants
(<
1
year
old)
0.033
52
0.1
0.006
160
Children
(
1
 
6
years
old)
0.033
38
0.1
0.006
200
Females
(
13
 
50
years
old)
0.033
19
0.1
0.006
800
2.
Chronic
risk.
Using
the
exposure
assumptions
described
in
this
unit
for
chronic
exposure,
EPA
has
concluded
that
exposure
to
bifenthrin
from
food
will
utilize
12%
of
the
cPAD
for
the
U.
S.
population,
13%
of
the
cPAD
for
infants
less
than
1
year
old
and
24%
of
the
cPAD
for
children
1
to
6
years
old.
Based
on
the
use
pattern,
chronic
residential
exposure
to
residues
of
bifenthrin
is
not
expected.
In
addition,
there
is
potential
for
chronic
dietary
exposure
to
bifenthrin
in
drinking
water.
After
calculating
DWLOCs
and
comparing
them
to
the
EECs
for
surface
and
ground
water,
EPA
does
not
expect
the
aggregate
exposure
to
exceed
100%
of
the
cPAD,
as
shown
in
Table
4
of
this
unit:

TABLE
4.
 
AGGREGATE
RISK
ASSESSMENT
FOR
CHRONIC
EXPOSURE
TO
BIFENTHRIN
Population
Subgroup
cPAD
mg/
kg/
day
%
cPAD
(
Food)
Surface
Water
EEC
(
ppb)
Ground
Water
EEC
(
ppb)
Chronic
DWLOC
(
ppb)

U.
S.
Population
0.004
12
0.1
0.006
120
All
Infants
(<
1
year
old)
0.004
13
0.1
0.006
35
Children
(
1
 
6
years
old)
0.004
24
0.1
0.006
30
3.
Short­
term
risk.
Short­
term
aggregate
exposure
takes
into
account
residential
exposure
plus
chronic
exposure
to
food
and
water
(
considered
to
be
a
background
exposure
level).
Bifenthrin
is
currently
registered
for
use
that
could
result
in
short­
term
residential
exposure
and
the
Agency
has
determined
that
it
is
appropriate
to
aggregate
chronic
food
and
water
and
short­
term
exposures
for
bifenthrin.
Using
the
exposure
assumptions
described
in
this
unit
for
short­
term
exposures,
EPA
has
concluded
that
food
and
residential
exposures
aggregated
result
in
aggregate
MOEs
of
544
to
1,070
for
adult
male
and
female
homeowners
applying
bifenthrin
to
turf,
treating
structural
wood
or
making
crack
and
crevice
applications
indoors.
EPA
has
further
concluded
that
food
and
residential
exposures
aggregated
result
in
aggregate
MOEs
of
354
for
children
(
toddlers)
with
post­
application
exposure
outdoors
and
694
for
children
(
toddlers)
with
post­
application
exposure
following
indoor
crack
and
crevice
treatments.
These
aggregate
MOEs
do
not
exceed
the
Agency's
level
of
concern
for
aggregate
exposure
to
food
and
residential
uses.
In
addition,
short­
term
DWLOCs
were
calculated
and
compared
to
the
EECs
for
chronic
exposure
of
bifenthrin
in
ground
and
surface
water.
After
calculating
DWLOCs
and
comparing
them
to
the
EECs
for
surface
and
ground
water,
EPA
does
not
expect
short­
term
aggregate
exposure
to
exceed
the
Agency's
level
of
concern,
as
shown
in
Table
5
of
this
unit:

VerDate
Jan<
31>
2003
12:
41
Apr
29,
2003
Jkt
200001
PO
00000
Frm
00041
Fmt
4700
Sfmt
4700
E:\
FR\
FM\
30APR1.
SGM
30APR1
23066
Federal
Register
/
Vol.
68,
No.
83
/
Wednesday,
April
30,
2003
/
Rules
and
Regulations
TABLE
5.
 
AGGREGATE
RISK
ASSESSMENT
FOR
SHORT­
TERM
EXPOSURE
TO
BIFENTHRIN
Population
Subgroup
Aggregate
MOE
(
Food
+
Residential)
Aggregate
Level
of
Concern
(
LOC)
Surface
Water
EEC
(
ppb)
Ground
Water
EEC
(
ppb)
Short­
Term
DWLOC
(
ppb)

Adult
Female:
Structural
Wood
Treatment
544
300
0.1
0.006
100
Adult
Male:
Structural
Wood
Treatment
546
300
0.1
0.006
120
Adult
Female:
Indoor
Crack
and
Crevice
Treatment
855
300
0.1
0.006
140
Adult
Male:
Indoor
Crack
and
Crevice
Treatment
858
300
0.1
0.006
170
Children
(
Toddler):
Outdoor
Post­
application
Exposure
354
300
0.1
0.006
11
Children
(
Toddler):
Indoor
Post­
application
Exposure
694
300
0.1
0.006
42
4.
Intermediate­
term
risk.
Intermediate­
term
aggregate
exposure
takes
into
account
residential
exposure
plus
chronic
exposure
to
food
and
water
(
considered
to
be
a
background
exposure
level).
Bifenthrin
is
currently
registered
for
use(
s)
that
could
result
in
intermediateterm
residential
exposure
and
the
Agency
has
determined
that
it
is
appropriate
to
aggregate
chronic
food
and
water
and
intermediate­
term
exposures
for
bifenthrin.
However,
since
short­
term
risk
estimates
for
residential
handler
and
post­
application
exposures
to
bifenthrin
represent
worst­
case
risk
estimates
for
intermediate­
term
scenarios,
separate
intermediate­
term
aggregate
risks
were
not
estimated.
Short­
term
risk
estimates
are
considered
to
represent
worst­
case
risk
estimates
for
intermediate­
term
scenarios
for
the
following
reasons.
The
toxic
endpoints
used
to
estimate
risks
for
intermediate­
term
dermal,
incidental
oral,
and
inhalation
exposures
for
bifenthrin
are
the
same
as
those
used
to
estimate
risks
from
shortterm
exposures.
In
addition,
EPA
used
the
same
residue
data
from
outdoor
(
turf)
and
indoor
(
hard­
surface)
studies
to
estimate
short
and
intermediate­
term
exposures.
Any
differences
in
the
exposure
estimates
are
a
result
of
the
assumptions
used
for
activity
patterns,
which
may
differ
for
short
versus
intermediate­
term
exposure
depending
on
the
scenario
assessed.
As
a
result
of
these
differences,
exposure
estimates
for
intermediate­
term
exposure
scenarios
are
either
equal
to
or
lower
than
exposure
estimates
for
short­
term
scenarios.
Consequently,
risk
estimates
(
MOEs)
for
intermediate­
term
exposures
are
equal
to
or
greater
than
MOEs
for
short­
term
exposures.
Since
short­
term
risk
estimates
are
below
levels
of
concern,
intermediate­
term
risk
estimates
are
also
below
levels
of
concern.
5.
Aggregate
cancer
risk
for
U.
S.
population.
Bifenthrin
has
been
classified
as
a
Category
C
(
possible
human)
carcinogen.
The
Agency
has
determined
that
the
reference
dose
(
RfD)
approach
should
be
used
for
quantification
of
human
risk.
Therefore,
the
chronic
aggregate
risk
assessment
described
above
in
Unit
III.
E.
2.
also
encompasses
chronic
aggregate
cancer
risk
from
bifenthrin.
6.
Determination
of
safety.
Based
on
these
risk
assessments,
EPA
concludes
that
there
is
a
reasonable
certainty
that
no
harm
will
result
to
the
general
population,
and
to
infants
and
children
from
aggregate
exposure
to
bifenthrin
residues.

IV.
Other
Considerations
A.
Analytical
Enforcement
Methodology
Adequate
enforcement
methods
are
available
for
determination
of
the
regulated
bifenthrin
residue
in
plants.
Crop
field
trial
samples
were
analyzed
for
residues
of
bifenthrin
using
FMC
Methods
P
 
1073,
P
 
1089,
P
 
1645M,
P
 
2132M,
P
 
3133,
or
P
 
3346.
These
methods
are
variations
of
two
other
methods
which
have
been
submitted
for
inclusion
in
PAM
II
(
FMC's
Methods
P
 
1031
and
RAN
 
0140).
These
methods
have
been
adequately
validated
and
are
adequate
for
data
collection.
The
methods
may
be
requested
from:
Chief,
Analytical
Chemistry
Branch,
Environmental
Science
Center,
701
Mapes
Rd.,
Ft.
Meade,
MD
20755
 
5350;
telephone
number:
(
410)
305
 
2905;
email
address:
residuemethods@
epa.
gov.

B.
International
Residue
Limits
The
Codex
Alimentarius
Commission
has
established
several
maximum
residue
limits
(
MRLs)
for
residues
of
bifenthrin
in/
on
various
commodities.
The
Codex
MRLs
are
expressed
in
terms
of
bifenthrin
per
se.
The
Codex
MRL
and
the
U.
S.
tolerance
expressions
are
compatible.
Of
the
new
commodities
for
which
tolerances
are
being
established,
Codex
MRLS
exist
only
for
pear,
grapefruit,
lemon
and
orange.
The
Codex
MRLs
of
0.5
ppm
for
pear
and
0.05
ppm
for
grapefruit,
lemon
and
orange
are
compatible
with
the
new
U.
S.
tolerances
for
pear
(
0.5
ppm)
and
citrus
fruit
(
0.05
ppm).
Codex
MRLs
have
not
been
established
for
bananas,
herbs,
tomatoes,
spinach
or
tree
nuts.
The
following
conclusions
can
be
made
regarding
efforts
to
harmonize
existing
(
i.
e.,
previously
established)
U.
S.
tolerances
with
Codex
MRLs:
(
i)
Compatibility
between
the
U.
S.
tolerances
and
Codex
MRLs
exists
for
maize
and
chicken
commodities
except
eggs;
(
ii)
incompatibility
of
the
U.
S.
tolerances
and
Codex
MRLs
remains
for
maize
forage
and
fodder,
strawberry,
eggs,
and
cattle
commodities
because
of
differences
in
agricultural
practices
and/
or
method
limits
of
quantitation.
No
questions
of
compatibility
exist
with
respect
to
commodities
where
Codex
MRLs
have
been
established
but
U.
S.
tolerances
do
not
exist.
There
are
no
Canadian
MRLs
established
for
bifenthrin.
Mexican
MRLs
have
been
established
for
bifentrin
at
0.5
ppm
for
cottonseed,
0.05
ppm
for
maize,
and
3
ppm
for
strawberry.
These
levels
are
compatible
with
the
U.
S.
tolerance
levels.

V.
Conclusion
Therefore,
tolerances
are
established
for
residues
of
bifenthrin,
(
2­
methyl[
1,1 ­
biphenyl]­
3­
yl)
methyl­
3­(
2­
chloro­
3,3,3­
trifluoro­
1­
propenyl)­
2,2­
dimethylcyclopropane­
carboxylate,
in
or
on
almond,
hulls
at
2.0
ppm;
banana
at
0.1
ppm;
fruit,
citrus,
group
10
at
0.05
ppm;
herb
subgroup
19A
at
0.05
ppm;
pear
at
0.5
ppm;
nut,
tree,
group
14
at
0.05
ppm;
spinach
at
0.2
ppm;
tomato
at
0.15
ppm;
and
food/
feed
products
in
food/
feed
handling
establishments
at
0.05
ppm.

VerDate
Jan<
31>
2003
12:
41
Apr
29,
2003
Jkt
200001
PO
00000
Frm
00042
Fmt
4700
Sfmt
4700
E:\
FR\
FM\
30APR1.
SGM
30APR1
23067
Federal
Register
/
Vol.
68,
No.
83
/
Wednesday,
April
30,
2003
/
Rules
and
Regulations
VI.
Objections
and
Hearing
Requests
Under
section
408(
g)
of
the
FFDCA,
as
amended
by
the
FQPA,
any
person
may
file
an
objection
to
any
aspect
of
this
regulation
and
may
also
request
a
hearing
on
those
objections.
The
EPA
procedural
regulations
which
govern
the
submission
of
objections
and
requests
for
hearings
appear
in
40
CFR
part
178.
Although
the
procedures
in
those
regulations
require
some
modification
to
reflect
the
amendments
made
to
the
FFDCA
by
the
FQPA,
EPA
will
continue
to
use
those
procedures,
with
appropriate
adjustments,
until
the
necessary
modifications
can
be
made.
The
new
section
408(
g)
of
the
FFDCA
provides
essentially
the
same
process
for
persons
to
``
object''
to
a
regulation
for
an
exemption
from
the
requirement
of
a
tolerance
issued
by
EPA
under
new
section
408(
d)
of
FFDCA,
as
was
provided
in
the
old
sections
408
and
409
of
the
FFDCA.
However,
the
period
for
filing
objections
is
now
60
days,
rather
than
30
days.

A.
What
Do
I
Need
to
Do
to
File
an
Objection
or
Request
a
Hearing?

You
must
file
your
objection
or
request
a
hearing
on
this
regulation
in
accordance
with
the
instructions
provided
in
this
unit
and
in
40
CFR
part
178.
To
ensure
proper
receipt
by
EPA,
you
must
identify
docket
ID
number
OPP
 
2002
 
0358
in
the
subject
line
on
the
first
page
of
your
submission.
All
requests
must
be
in
writing,
and
must
be
mailed
or
delivered
to
the
Hearing
Clerk
on
or
before
June
30,
2003.
1.
Filing
the
request.
Your
objection
must
specify
the
specific
provisions
in
the
regulation
that
you
object
to,
and
the
grounds
for
the
objections
(
40
CFR
178.25).
If
a
hearing
is
requested,
the
objections
must
include
a
statement
of
the
factual
issues(
s)
on
which
a
hearing
is
requested,
the
requestor's
contentions
on
such
issues,
and
a
summary
of
any
evidence
relied
upon
by
the
objector
(
40
CFR
178.27).
Information
submitted
in
connection
with
an
objection
or
hearing
request
may
be
claimed
confidential
by
marking
any
part
or
all
of
that
information
as
CBI.
Information
so
marked
will
not
be
disclosed
except
in
accordance
with
procedures
set
forth
in
40
CFR
part
2.
A
copy
of
the
information
that
does
not
contain
CBI
must
be
submitted
for
inclusion
in
the
public
record.
Information
not
marked
confidential
may
be
disclosed
publicly
by
EPA
without
prior
notice.
Mail
your
written
request
to:
Office
of
the
Hearing
Clerk
(
1900C),
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001.
You
may
also
deliver
your
request
to
the
Office
of
the
Hearing
Clerk
in
Rm.
104,
Crystal
Mall
#
2,
1921
Jefferson
Davis
Hwy.,
Arlington,
VA.
The
Office
of
the
Hearing
Clerk
is
open
from
8
a.
m.
to
4
p.
m.,
Monday
through
Friday,
excluding
legal
holidays.
The
telephone
number
for
the
Office
of
the
Hearing
Clerk
is
(
703)
603
 
0061.
2.
Tolerance
fee
payment.
If
you
file
an
objection
or
request
a
hearing,
you
must
also
pay
the
fee
prescribed
by
40
CFR
180.33(
i)
or
request
a
waiver
of
that
fee
pursuant
to
40
CFR
180.33(
m).
You
must
mail
the
fee
to:
EPA
Headquarters
Accounting
Operations
Branch,
Office
of
Pesticide
Programs,
PO
Box
360277M,
Pittsburgh,
PA
15251.
Please
identify
the
fee
submission
by
labeling
it
``
Tolerance
Petition
Fees.''
EPA
is
authorized
to
waive
any
fee
requirement
``
when
in
the
judgement
of
the
Administrator
such
a
waiver
or
refund
is
equitable
and
not
contrary
to
the
purpose
of
this
subsection.''
For
additional
information
regarding
the
waiver
of
these
fees,
you
may
contact
James
Tompkins
by
phone
at
(
703)
305
 
5697,
by
e­
mail
at
tompkins.
jim@
epa.
gov,
or
by
mailing
a
request
for
information
to
Mr.
Tompkins
at
Registration
Division
(
7505C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001.
If
you
would
like
to
request
a
waiver
of
the
tolerance
objection
fees,
you
must
mail
your
request
for
such
a
waiver
to:
James
Hollins,
Information
Resources
and
Services
Division
(
7502C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001.
3.
Copies
for
the
Docket.
In
addition
to
filing
an
objection
or
hearing
request
with
the
Hearing
Clerk
as
described
in
Unit
VI.
A.,
you
should
also
send
a
copy
of
your
request
to
the
PIRIB
for
its
inclusion
in
the
official
record
that
is
described
in
Unit
I.
B.
1.
Mail
your
copies,
identified
by
docket
ID
number
OPP
 
2002
 
0358,
to:
Public
Information
and
Records
Integrity
Branch,
Information
Resources
and
Services
Division
(
7502C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001.
In
person
or
by
courier,
bring
a
copy
to
the
location
of
the
PIRIB
described
in
Unit
I.
B.
1.
You
may
also
send
an
electronic
copy
of
your
request
via
e­
mail
to:
oppdocket
epa.
gov.
Please
use
an
ASCII
file
format
and
avoid
the
use
of
special
characters
and
any
form
of
encryption.
Copies
of
electronic
objections
and
hearing
requests
will
also
be
accepted
on
disks
in
WordPerfect
6.1/
8.0
or
ASCII
file
format.
Do
not
include
any
CBI
in
your
electronic
copy.
You
may
also
submit
an
electronic
copy
of
your
request
at
many
Federal
Depository
Libraries.

B.
When
Will
the
Agency
Grant
a
Request
for
a
Hearing?
A
request
for
a
hearing
will
be
granted
if
the
Administrator
determines
that
the
material
submitted
shows
the
following:
There
is
a
genuine
and
substantial
issue
of
fact;
there
is
a
reasonable
possibility
that
available
evidence
identified
by
the
requestor
would,
if
established
resolve
one
or
more
of
such
issues
in
favor
of
the
requestor,
taking
into
account
uncontested
claims
or
facts
to
the
contrary;
and
resolution
of
the
factual
issues(
s)
in
the
manner
sought
by
the
requestor
would
be
adequate
to
justify
the
action
requested
(
40
CFR
178.32).

VII.
Statutory
and
Executive
Order
Reviews
This
final
rule
establishes
a
tolerance
under
section
408(
d)
of
the
FFDCA
in
response
to
a
petition
submitted
to
the
Agency.
The
Office
of
Management
and
Budget
(
OMB)
has
exempted
these
types
of
actions
from
review
under
Executive
Order
12866,
entitled
Regulatory
Planning
and
Review
(
58
FR
51735,
October
4,
1993).
Because
this
rule
has
been
exempted
from
review
under
Executive
Order
12866
due
to
its
lack
of
significance,
this
rule
is
not
subject
to
Executive
Order
13211,
Actions
Concerning
Regulations
That
Significantly
Affect
Energy
Supply,
Distribution,
or
Use
(
66
FR
28355,
May
22,
2001).
This
final
rule
does
not
contain
any
information
collections
subject
to
OMB
approval
under
the
Paperwork
Reduction
Act
(
PRA),
44
U.
S.
C.
3501
et
seq.,
or
impose
any
enforceable
duty
or
contain
any
unfunded
mandate
as
described
under
Title
II
of
the
Unfunded
Mandates
Reform
Act
of
1995
(
UMRA)
(
Public
Law
104
 
4).
Nor
does
it
require
any
special
considerations
under
Executive
Order
12898,
entitled
Federal
Actions
to
Address
Environmental
Justice
in
Minority
Populations
and
Low­
Income
Populations
(
59
FR
7629,
February
16,
1994);
or
OMB
review
or
any
Agency
action
under
Executive
Order
13045,
entitled
Protection
of
Children
from
Environmental
Health
Risks
and
Safety
Risks
(
62
FR
19885,
April
23,
1997).
This
action
does
not
involve
any
technical
standards
that
would
require
Agency
consideration
of
voluntary
consensus
standards
pursuant
to
section
12(
d)
of
the
National
Technology
Transfer
and
Advancement
Act
of
1995
(
NTTAA),
Public
Law
104
 
113,
section
12(
d)
(
15
U.
S.
C.
272
note).
Since
VerDate
Jan<
31>
2003
12:
41
Apr
29,
2003
Jkt
200001
PO
00000
Frm
00043
Fmt
4700
Sfmt
4700
E:\
FR\
FM\
30APR1.
SGM
30APR1
23068
Federal
Register
/
Vol.
68,
No.
83
/
Wednesday,
April
30,
2003
/
Rules
and
Regulations
tolerances
and
exemptions
that
are
established
on
the
basis
of
a
petition
under
section
408(
d)
of
the
FFDCA,
such
as
the
tolerance
in
this
final
rule,
do
not
require
the
issuance
of
a
proposed
rule,
the
requirements
of
the
Regulatory
Flexibility
Act
(
RFA)
(
5
U.
S.
C.
601
et
seq.)
do
not
apply.
In
addition,
the
Agency
has
determined
that
this
action
will
not
have
a
substantial
direct
effect
on
States,
on
the
relationship
between
the
national
government
and
the
States,
or
on
the
distribution
of
power
and
responsibilities
among
the
various
levels
of
government,
as
specified
in
Executive
Order
13132,
entitled
Federalism(
64
FR
43255,
August
10,
1999).
Executive
Order
13132
requires
EPA
to
develop
an
accountable
process
to
ensure
``
meaningful
and
timely
input
by
State
and
local
officials
in
the
development
of
regulatory
policies
that
have
federalism
implications.''
``
Policies
that
have
federalism
implications''
is
defined
in
the
Executive
order
to
include
regulations
that
have
``
substantial
direct
effects
on
the
States,
on
the
relationship
between
the
national
government
and
the
States,
or
on
the
distribution
of
power
and
responsibilities
among
the
various
levels
of
government.''
This
final
rule
directly
regulates
growers,
food
processors,
food
handlers
and
food
retailers,
not
States.
This
action
does
not
alter
the
relationships
or
distribution
of
power
and
responsibilities
established
by
Congress
in
the
preemption
provisions
of
section
408(
n)(
4)
of
the
FFDCA.
For
these
same
reasons,
the
Agency
has
determined
that
this
rule
does
not
have
any
``
tribal
implications''
as
described
in
Executive
Order
13175,
entitled
Consultation
and
Coordination
with
Indian
Tribal
Governments
(
65
FR
67249,
November
6,
2000).
Executive
Order
13175,
requires
EPA
to
develop
an
accountable
process
to
ensure
``
meaningful
and
timely
input
by
tribal
officials
in
the
development
of
regulatory
policies
that
have
tribal
implications.''
``
Policies
that
have
tribal
implications''
is
defined
in
the
Executive
order
to
include
regulations
that
have
``
substantial
direct
effects
on
one
or
more
Indian
tribes,
on
the
relationship
between
the
Federal
Government
and
the
Indian
tribes,
or
on
the
distribution
of
power
and
responsibilities
between
the
Federal
Government
and
Indian
tribes.''
This
rule
will
not
have
substantial
direct
effects
on
tribal
governments,
on
the
relationship
between
the
Federal
Government
and
Indian
tribes,
or
on
the
distribution
of
power
and
responsibilities
between
the
Federal
Government
and
Indian
tribes,
as
specified
in
Executive
Order
13175.
Thus,
Executive
Order
13175
does
not
apply
to
this
rule.

VIII.
Congressional
Review
Act
The
Congressional
Review
Act,
5
U.
S.
C.
801
et
seq.,
as
added
by
the
Small
Business
Regulatory
Enforcement
Fairness
Act
of
1996,
generally
provides
that
before
a
rule
may
take
effect,
the
agency
promulgating
the
rule
must
submit
a
rule
report,
which
includes
a
copy
of
the
rule,
to
each
House
of
the
Congress
and
to
the
Comptroller
General
of
the
United
States.
EPA
will
submit
a
report
containing
this
rule
and
other
required
information
to
the
U.
S.
Senate,
the
U.
S.
House
of
Representatives,
and
the
Comptroller
General
of
the
United
States
prior
to
publication
of
this
final
rule
in
the
Federal
Register.
This
final
rule
is
not
a
``
major
rule''
as
defined
by
5
U.
S.
C.
804(
2).

List
of
Subjects
in
40
CFR
Part
180
Environmental
protection,
Administrative
practice
and
procedure,
Agricultural
commodities,
Pesticides
and
pests,
Reporting
and
recordkeeping
requirements.

Dated:
April
16,
2003.
Debra
Edwards,
Director,
Registration
Division,
Office
of
Pesticide
Programs.


Therefore,
40
CFR
chapter
I
is
amended
as
follows:

PART
180
 
[
AMENDED]


1.
The
authority
citation
for
part
180
continues
to
read
as
follows:

Authority:
21
U.
S.
C.
321(
q),
346(
a)
and
371.


2.
Section
180.442
is
amended
in
paragraph
(
a)
by
designating
the
text
following
the
paragraph
heading
as
paragraph
(
a)(
1);
by
adding
alphabetically
commodities
to
the
table
in
newly
designated
paragraph
(
a)(
1),
by
adding
paragraph
(
a)(
2),
and
in
the
table
to
paragraph
(
b)
by
deleting
the
entries
for
``
Citrus;''
``
Citrus,
dried
pulp;''
and
``
Citrus,
oil.''.

§
180.442
Bifenthrin;
tolerances
for
residues.

(
a)
General.
(
1)
*
*
*

Commodity
Parts
per
million
Almond,
hulls
............................
2.0
*
*
*
*
*
Banana1
....................................
0.1
*
*
*
*
*
Fruit,
citrus,
group
10
...............
0.05
*
*
*
*
*
Herb
subgroup
19A
..................
0.05
Commodity
Parts
per
million
*
*
*
*
*
Nut,
tree,
group
14
...................
0.05
*
*
*
*
*
Pear
..........................................
0.5
*
*
*
*
*
Spinach
.....................................
0.2
*
*
*
*
*
Tomato
......................................
0.15
*
*
*
*
*

1
There
are
no
U.
S.
registrations
as
of
April
30,
2003.

(
2)
A
tolerance
of
0.05
ppm
is
established
for
residues
of
the
insecticide
bifenthrin,
(
2­
methyl[
1,1 ­
biphenyl]­
3­
yl)
methyl­
3­(
2­
chloro­
3,3,3­
trifluoro­
1­
propenyl)­
2,2­
dimethylcyclopropane­
carboxylate,
as
follows:
(
i)
In
or
on
all
food/
feed
items
(
other
than
those
covered
by
a
higher
tolerance
as
a
result
of
use
on
growing
crops)
in
food/
feed
handling
establishments.
(
ii)
The
insecticide
may
be
present
as
a
residue
from
application
of
bifenthrin
in
food
handling
establishments,
including
food
service,
manufacturing
and
processing
establishments,
such
as
restaurants,
cafeterias,
supermarkets,
bakeries,
breweries,
dairies,
meat
slaughtering
and
packing
plants,
and
canneries,
feed
handling
establishments
including
feed
manufacturing
and
processing
establishments,
in
accordance
with
the
following
prescribed
conditions:
(
A)
Application
shall
be
limited
to
general
surface
and
spot
and/
or
crack
and
crevice
treatment
in
food/
feed
handling
establishments
where
food/
feed
and
food/
feed
products
are
held,
processed,
prepared
and
served.
General
surface
application
may
be
used
only
when
the
facility
is
not
in
operation
provided
exposed
food/
feed
has
been
covered
or
removed
from
the
area
being
treated.
Spot
and/
or
crack
and
crevice
application
may
be
used
while
the
facility
is
in
operation
provided
exposed
food/
feed
is
covered
or
removed
from
the
area
being
treated
prior
to
application.
Spray
concentration
shall
be
limited
to
a
maximum
of
0.06
percent
active
ingredient.
Contamination
of
food/
feed
or
food/
feed
contact
surfaces
shall
be
avoided.
(
B)
To
assure
safe
use
of
the
insecticide,
its
label
and
labeling
shall
conform
to
that
registered
with
the
U.
S.
Environmental
Protection
Agency
and
shall
be
used
in
accordance
with
such
label
and
labeling.
*
*
*
*
*
[
FR
Doc.
03
 
10400
Filed
4
 
29
 
03;
8:
45
am]

BILLING
CODE
6560
 
50
 
S
VerDate
Jan<
31>
2003
12:
41
Apr
29,
2003
Jkt
200001
PO
00000
Frm
00044
Fmt
4700
Sfmt
4700
E:\
FR\
FM\
30APR1.
SGM
30APR1