55494
Federal
Register
/
Vol.
68,
No.
187
/
Friday,
September
26,
2003
/
Rules
and
Regulations
ENVIRONMENTAL
PROTECTION
AGENCY
40
CFR
Part
180
[
OPP
 
2003
 
0297;
FRL
 
7328
 
1]

Bifenazate;
Pesticide
Tolerances
AGENCY:
Environmental
Protection
Agency
(
EPA).

ACTION:
Final
rule.

SUMMARY:
This
regulation
establishes
tolerances
for
combined
residues
of
bifenazate
and
diazinecarboxylic
acid,
2­(
4­
methoxy­[
1,1'­
biphenyl]­
3­
yl),
1­
methylethyl
ester
(
expressed
as
bifenazate)
in
or
on
almond,
hulls;
nut,
tree,
group
14;
okra;
peppermint,
tops;
pistachio;
spearmint,
tops;
vegetable,
cucurbit,
group
9;
and,
vegetable,
fruiting,
group
8;
and
increases
the
established
tolerances
for
combined
residues
of
bifenazate;
diazinecarboxylic
acid,
2­(
4­
methoxy­[
1,1'­
biphenyl]­
3­
yl),
1­
methylethyl
ester
(
expressed
as
bifenazate);
1,1'­
biphenyl,
4­
ol;
and
1,1'­
biphenyl,
4­
oxysulfonic
acid
(
expressed
as
1,1'­
biphenyl,
4­
ol)
in
meat
and
meat
byproducts
of
cattle,
goat,
hog,
horse,
and
sheep
and
milk.
EPA
is
also
deleting
the
bifenazate
time­
limited
tolerance
for
tomato,
which
is
established
in
connection
with
a
section
18
emergency
exemption.
Tomato
is
included
in
the
tolerance
established
by
this
action
for
vegetable,
fruiting
group
8.
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
September
26,
2003.
Objections
and
requests
for
hearings,
identified
by
docket
ID
number
OPP
 
2003
 
0297,
must
be
received
on
or
before
November
25,
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:
Shaja
R.
Brothers,
Registration
Division
(
7505C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001;
telephone
number:
(
703)
308
 
3194;
e­
mail
address:
brothers.
shaja@
epa.
gov.

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

You
may
be
potentially
affected
by
this
action
if
you
are
an
agricultural
producer,
food
manufacturer,
and
pesticide
manufacturer.
Potentially
affected
entities
may
include,
but
are
not
limited
to:
 
Industry
(
NAISC
111,
112,
311,
32532),
e.
g.,
Crop
production,
Animal
production,
Food
manufacturing,
and
Pesticide
manufacturing.
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
 
2003
 
0297.
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
January
15,
2003
(
68
FR
2032)
(
FRL
 
7286
 
4),
EPA
issued
a
notice
pursuant
to
section
408
of
FFDCA,
21
U.
S.
C.
346a,
as
amended
by
FQPA
(
Public
Law
104
 
170),
announcing
the
filing
of
pesticide
petition
(
PP
2E6517)
by
IR
 
4,
681
US
Highway
1
South,
New
Brunswick,
NJ
08902
 
3390.
That
notice
included
a
summary
of
the
petition
prepared
by
Crompton
Manufacturing
Company,
Inc.
(
formerly
Uniroyal
Chemical
Company),
Middlebury,
CT
06749,
the
registrant.
The
petition
requested
that
40
CFR
180.572
be
amended
by
establishing
tolerances
for
combined
residues
of
the
miticide,
bifenazate,
(
1­
methylethyl
2­
(
4­
methoxy[
1,1'­
biphenyl]­
3­
yl)
hydrazinecarboxylate)
and
diazinecarboxylic
acid,
2­(
4­
methoxy­
[
1,1'­
biphenyl]­
3­
yl),
1­
methylethyl
ester
(
expressed
as
bifenazate),
in
or
on
the
following
commodities:
Nut,
tree,
group
14
at
0.20
ppm;
okra
at
2.0
ppm;
peppermint,
tops
at
25
ppm;
pistachio
at
0.20
ppm;
spearmint,
tops
at
25
ppm;
vegetable,
cucurbit,
group
9
at
0.75
ppm;
and
vegetable,
fruiting,
group
8
at
2.0
ppm.
The
petition
was
subsequently
amended
by
IR­
4
to
also
propose
tolerances
for
combined
residues
of
bifenazate
and
diazinecarboxylic
acid
in
or
on
almond
hulls
at
15
ppm;
and
to
propose
increases
to
the
established
bifenazate
meat,
meat
byproducts
and
milk
tolerances;
and
to
change
the
tolerance
expression
for
meat,
meat
byproducts
and
milk.
IR­
4
proposes
tolerances
for
combined
residues
of
bifenazate,
(
1­
methylethyl
2­(
4­
methoxy[
1,1'­
biphenyl]­
3­
yl)
hydrazinecarboxylate);
diazinecarboxylic
acid,
2­(
4­
methoxy­
[
1,1'­
biphenyl]­
3­
yl),
1­
methylethyl
ester
(
expressed
as
bifenazate);
1,1'­
biphenyl,
4­
ol;
and
1,1'­
biphenyl,
4­
oxysulfonic
acid
(
expressed
as
1,1'­
biphenyl,
4­
ol)
in
or
on
meat
and
meat
byproducts
of
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187
/
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26,
2003
/
Rules
and
Regulations
cattle,
goat,
hog,
horse,
and
sheep
at
0.02
ppm
and
milk
at
0.02
ppm.
There
were
no
comments
received
on
these
petitions.
EPA
has
received
objections
to
tolerances
it
established
for
residues
of
bifenazate
on
a
variety
of
food
commodities
in
a
final
rule
published
in
the
Federal
Register
of
February
1,
2002
(
67
FR
4913)
(
FRL
 
6818
 
3).
The
objections
were
filed
by
the
Natural
Resources
Defense
Council
(
NRDC)
and
raised
several
issues
regarding
aggregate
exposure
estimates
and
the
additional
safety
factor
for
the
protection
of
infants
and
children.
NRDC's
objections
raise
complex
legal,
scientific,
policy,
and
factual
matters
and
EPA
has
initiated
a
public
comment
period
on
them
in
the
Federal
Register
of
June
19,
2002
(
67
FR
41628)
(
FRL
 
7167
 
7),
which
ended
on
October
16,
2002.
Although
that
proceeding
remains
ongoing,
prior
to
acting
on
this
current
tolerance
action,
EPA
reviewed
the
bifenazate­
specific
objections
raised
by
NRDC
and
has
addressed
them
at
relevant
points
throughout
this
preamble.
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
tolerances
for
combined
residues
of
bifenazate
and
diazinecarboxylic
acid,
2­(
4­
methoxy­
[
1,1'­
biphenyl]­
3­
yl),
1­
methylethyl
ester
(
expressed
as
bifenazate)
on
almond,
hulls
at
15
ppm;
nut,
tree,
group
14
at
0.20
ppm;
okra
at
2.0
ppm;
peppermint,
tops
at
25
ppm;
pistachio
at
0.20
ppm;
spearmint,
tops
at
25
ppm;
vegetable,
cucurbit,
group
9
at
0.75
ppm;
and
vegetable,
fruiting,
group
8
at
2.0
ppm,
and
combined
residues
of
bifenazate;
diazinecarboxylic
acid,
2­(
4­
methoxy­
[
1,1'­
biphenyl]­
3­
yl),
1­
methylethyl
ester
(
expressed
as
bifenazate);
1,1'­
biphenyl,
4­
ol;
and
1,1'­
biphenyl,
4­
oxysulfonic
acid
(
expressed
as
1,1'­
biphenyl,
4­
ol)
in
meat
and
meat
byproducts
of
cattle,
goat,
hog,
horse,
and
sheep
at
0.02
ppm
and
milk
at
0.02
ppm.
EPA's
assessment
of
exposures
and
risks
associated
with
establishing
the
tolerances
follow.

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
bifenazate
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
No.
Study
Results
870.3100
90­
Day
oral
toxicity
rodents
 
rat
NOAEL
=
13.8
mg/
kg/
day
in
males,
3.2
mg/
kg/
day
in
females.
LOAEL
=
27.7
mg/
kg/
day
in
males,
16.3
mg/
kg/
day
in
females
based
on
decreased
body
weight
gain
in
both
sexes,
decreased
liver
weight
in
males,
increased
spleen
weight
in
females,
and
histopathology
in
liver
in
both
sexes,
and
histopathological
changes
in
the
spleen
and
adrenal
cortex
in
males.

870.3150
90­
Day
oral
toxicity
nonrodents
 
dog
NOAEL
=
0.9
mg/
kg/
day
in
males,
1.3
mg/
kg/
day
in
females.
LOAEL
=
10.4
mg/
kg/
day
in
males,
10.7
mg/
kg/
day
in
females
based
on
changes
in
hematological
parameters
in
both
sexes,
increased
bilirubin
in
the
urine
in
males,
increased
absolute
and
relative
liver
weight
in
females
and
liver
histopathologic
effects
in
both
sexes.

870.3200
21­
Day
dermal
toxicity
 
rat
NOAEL
=
80
mg/
kg/
day
in
males
and
females.
LOAEL
=
400
mg/
kg/
day
in
males
and
females
based
on
decreased
body
weight
in
females,
decreased
food
consumption
in
both
sexes,
increased
urinary
ketones,
increased
urinary
protein,
increased
urinary
specific
gravity,
and
decreased
urinary
volume
in
both
sexes,
and
increased
incidence
of
extramedullary
hematopoiesis
in
the
spleen
in
both
sexes.

870.3700
Prenatal
developmental
in
rodents
 
rat
Maternal
NOAEL
=
10
mg/
kg/
day.
LOAEL
=
100
mg/
kg/
day
based
on
increased
clinical
signs,
and
decreased
body
weight,
body
weight
gain,
and
food
consumption.
Developmental
NOAEL
=
500
mg/
kg/
day.
LOAEL
=
not
established
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Vol.
68,
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187
/
Friday,
September
26,
2003
/
Rules
and
Regulations
TABLE
1.
 
SUBCHRONIC,
CHRONIC,
AND
OTHER
TOXICITY
 
Continued
Guideline
No.
Study
Results
870.3700
Prenatal
developmental
in
nonrodents
 
rabbit
Maternal
NOAEL
=
200
mg/
kg/
day
LOAEL
=
not
established;
the
dosing
in
this
study
are
considered
adequate
based
on
the
results
of
a
range
finding
study
in
which
a
treatment­
related
increase
in
the
number
of
does
aborting
was
seen
at
250
mg/
kg/
day
and
above.
Developmental
NOAEL
=
200
mg/
kg/
day
LOAEL
=
not
established
870.3800
Reproduction
and
fertility
effects
 
rat
Parental/
Systemic
NOAEL
=
1.6
mg/
kg/
day
in
males,
1.8
mg/
kg/
day
in
females.
LOAEL
=
6.5
mg/
kg/
day
in
males
and
7.4
mg/
kg/
day
in
females
based
on
decreased
body
weight,
body
weight
gain,
and
food
consumption
in
both
sexes.
Reproductive
NOAEL
=
16.4
mg/
kg/
day
in
males,
18.3
mg/
kg/
day
in
females.
LOAEL
=
not
established.
Offspring
NOAEL
=
16.4
mg/
kg/
day
in
males,
18.3
mg/
kg/
day
in
females.
LOAEL
=
not
established
870.4100
Chronic
toxicity
dogs
NOAEL
=
1.01
mg/
kg/
day
in
males,
1.05
mg/
kg/
day
in
females
LOAEL
=
8.95
mg/
kg/
day
in
males,
10.42
mg/
kg/
day
in
females
based
on
changes
in
hematological
and
clinical
chemistry
parameters
in
both
sexes
and
histopathological
effects
in
bone
marrow,
liver,
and
kidney
in
both
sexes.

870.4300
Chronic/
Carcino­
genicity
rats
NOAEL
=
3.9
mg/
kg/
day
in
males,
4.8
mg/
kg/
day
in
females.
LOAEL
=
9.7
mg/
kg/
day
in
males
and
9.7
mg/
kg/
day
in
females
based
on
decreased
body
weight,
body
weight
gain,
and
food
consumption
in
both
sexes.
No
evidence
of
carcinogenicity
870.4300
Carcinogenicity
mice
NOAEL
=
1.5
mg/
kg/
day
in
males,
19.7
mg/
kg/
day
in
females.
LOAEL
=
15.4
mg/
kg/
day
in
males,
35.7
mg/
kg/
day
in
females
based
on
decreased
body
weight
and
body
weight
gain
in
females
and
hematological
effects
and
decreased
kidney
weight
in
males.
No
evidence
of
carcinogenicity
870.5265
Gene
Mutation
Non­
mutagenic
when
tested
up
to
5000
ug/
plate,
in
presence
and
absence
of
activation
in
S.
typhimurium
strains
TA98,
TA100,
TA1535,
and
TA1537
and
E.
coli
strain
WP2uvra.

870.5300
Gene
Mutation
Non­
mutagenic
at
the
TK
locus
in
L5178Y
mouse
lymphoma
cells
tested
up
to
cytotoxic
concentrations
or
limit
of
solubility,
in
presence
and
absence
of
S­
9
activation

870.5375
Chromosome
aberration
Did
not
induce
structural
chromosome
aberration
in
CHO­
K1
cell
cultures
in
the
presence
and
absence
of
activation
up
to
cytotoxic
concentrations.

870.5385
Chromosomal
aberration
Non­
mutagenic
in
ICR
mouse
bone
marrow
micronucleus
chromosomal
aberrations
assay
up
to
cytotoxic
concentrations.

870.7485
Metabolism
and
pharmacokinetics
 
rat
Total
recovery
of
the
administered
dose
was
<
93%
for
all
treatment
groups.
Fecal
excretion
was
the
major
route
of
elimination
(
66
 
83%
of
the
dose),
with
eight
primary
metabolites
detected.
These
metabolites,
as
well
as
those
identified
in
the
urine
and
bile,
were
the
result
of
metabolic
reactions
including
hydrazine
oxidation
demethylation,
ring
hydroxylation,
and
molecular
scission
with
the
loss
of
hydrazinecarboxylic
acid
portion
with
subsequent
conjugation.

In
its
objection
to
a
separate
bifenazate
tolerance
action,
NRDC,
asserts
that
developmental
toxicity
is
a
data
gap
for
bifenzate.
NRDC
appears
to
be
referring
to
language
in
the
Table
1,
Unit
III.
A.
of
the
Federal
Register
final
rule
of
February
1,
2002,
that
states
that
a
clear
assessment
of
developmental
toxicity
was
not
possible
in
the
range
finding
study
used
to
choose
the
dose
levels
for
the
developmental
toxicity
study
in
rabbits.
The
Agency
concludes
there
are
acceptable
developmental
toxicity
studies
conducted
with
bifenazate
in
rats
and
in
rabbits,
and
an
acceptable
2­
generation
reproduction
study
in
rats,
which
are
described
in
Table
1.
of
this
unit.

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
intra
species
differences.
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
factors
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/
Rules
and
Regulations
(
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.
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
bifenazate
used
for
human
risk
assessment
is
shown
is
shown
in
Table
2
of
this
unit:

TABLE
2.
 
SUMMARY
OF
TOXICOLOGICAL
DOSE
AND
ENDPOINTS
FOR
BIFENAZATE
FOR
USE
IN
HUMAN
RISK
ASSESSMENT
Exposure
Scenario
Dose
Used
in
Risk
Assessment
UF
Special
FQPA
SF
and
Level
of
Concern
for
Risk
Assessment
Study
and
Toxicological
Effects
Acute
Dietary;
general
population
and
females
13
 
50
years
old
NA
NA
An
acute
dietary
endpoint
was
not
selected
based
on
the
absence
of
an
appropriate
endpoint
attributed
to
a
single
dose.

Chronic
Dietary;
all
populations
NOAEL=
1.0
mg/
kg/
day
UF
=
100
cRfD
=
0.01
mg/
kg/
day
Special
FQPA
SF
=
1X
cPAD
=
0.01
mg/
kg/
day
LOAEL
=
8.9/
10.4
mg/
kg/
day
[
M/
F]
based
on
changes
in
hematological
and
clinical
chemistry
parameters,
and
histopathology
in
bone
marrow,
liver,
and
kidney
in
the
One
Year
Dog
Feeding
Study
Incidental
Oral,
Short
Term
(
1
 
30
days)
oral
NOAEL
=
10
mg/
kg/
day
LOC
for
MOE
 
100
(
residential
Maternal
LOAEL
=
100
mg/
kg/
day
based
on
clinical
signs,
decreased
body
weight
and
food
consumption
during
the
dosing
period
in
the
Rat
Developmental
Study
Incidental
Oral,
Intermediate
Term
(
30
days­
6
months)
oral
NOAEL
=
0.9
mg/
kg/
day
LOC
for
MOE
 
100
(
residential
LOAEL
=
10.4/
10.7
mg/
kg/
day
[
M/
F]
based
on
changes
in
hematologic
parameters
in
the
90­
Day
Subchronic
Dog
Study
Short­,
Intermediate­
and
Long­
Term
Dermal
(
1­
30
days,
30
days­
6
months,
and
six
months
to
lifetime)
dermal
NOAEL=
80
mg/
kg/
day
LOC
for
MOE
 
100
(
residential
LOAEL
=
400
mg/
kg/
day
based
on
decreased
body
weight
and
food
consumption,
hematologic
effects,
increased
spleen
weight
and
extramedullary
hemapoiesis
in
the
spleen
in
the
21­
Day
Dermal
Toxicity
Study
in
Rats
Short­
Term
Inhalation
(
1
 
30
days)
oral
NOAEL=
10
mg/
kg/
day
inhalation
absorption
rate
=
100%
LOC
for
MOE
 
100
(
residential
LOAEL
=
100
mg/
kg/
day
based
on
decreased
body
weight
and
food
consumption
in
the
Rat
Developmental
Study
Intermediate­
Term
Inhalation
(
30
days­
6
months)
oral
NOAEL=
0.9
mg/
kg/
day
inhalation
absorption
rate
=
100%
LOC
for
MOE
 
100
(
residential
LOAEL
=
10.4/
10.7
mg/
kg/
day
based
on
changes
in
hematologic
parameters
in
the
90­
Day
Dog
Feeding
Study
Long­
Term
Inhalation
six
months­
lifetime)
Oral
study
NOAEL=
1.0
mg/
kg/
day
(
inhalation
absorption
rate
=
100%)
LOC
for
MOE
 
100
(
residential
LOAEL
=
8.9/
10.4
mg/
kg/
day
[
M/
F]
based
on
changes
in
hematological
and
clinical
chemistry
parameters,
and
histopathology
in
bone
marrow,
liver,
and
kidney
in
the
One
Year
Dog
Feeding
Study
Cancer
(
oral,
dermal,
inhalation)
NA
NA
Bifenazate
is
classified
as
not
likely
to
be
a
human
carcinogen
C.
Exposure
Assessment
1.
Dietary
exposure
from
food
and
feed
uses.
Tolerances
have
been
established
(
40
CFR
180.572)
for
the
combined
residues
of
bifenazate,
and
D3598
expressed
as
bifenazate
(
diazinecarboxylic
acid,
2­(
4­
methoxy­
1,1'­
biphenyl]­
3­
yl),
1­
methylethylester),
in
or
on
a
variety
of
food
commodities.
Risk
assessments
were
conducted
by
EPA
to
assess
dietary
exposures
from
bifenazate
in
food
as
follows:
i.
Acute
exposure.
An
acute
dietary
reference
dose
(
RfD)
for
the
females
13
 
50
years
of
age
and
the
general
population,
including
infants
and
children,
was
not
selected
because
an
acute
oral
endpoint
attributed
to
a
single­
dose
exposure
could
not
be
identified
in
any
of
the
studies
in
the
toxicology
data
base,
including
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Rules
and
Regulations
developmental
and
maternal
toxicity
in
the
developmental
toxicity
studies.
ii.
Chronic
exposure.
In
conducting
this
chronic
dietary
risk
assessment
EPA
used
the
Dietary
Exposure
Evaluation
Model
software
with
the
Food
Commodity
Intake
Database
(
DEEMFCIDTM
which
incorporates
food
consumption
data
as
reported
by
respondents
in
the
USDA
1994
 
1996
and
1998
nationwide
Continuing
Surveys
of
Food
Intake
by
Individuals
(
CSFII)
and
accumulated
exposure
to
the
chemical
for
each
commodity.
The
following
assumptions
was
made
for
the
chronic
exposure
assessment:
The
chronic
dietary
exposure
analysis
assumed
tolerance
level
residues
and
100%
crop
treated
for
all
registered
and
proposed
crops
excluding
tomato
where
average
field
trial
residues
were
used.
DEEM
(
ver
7.73)
default
processing
factors
were
assumed
for
all
commodities
excluding
apple
juice,
grape
juice,
wine/
sherry,
tomato
paste,
and
tomato
puree.
The
processing
factors
for
these
commodities
were
reduced
to
0.23,
0.17,
0.17,
5.0,
and
5.0,
respectively,
based
on
data
from
processing
studies.
In
its
objections
to
the
earlier
bifenazate
tolerance
action,
NRDC
claims
that
EPA
relied
upon
unsupported
and
apparently
arbitrary
processing
factors
to
reduce
estimates
of
dietary
exposure
to
bifenazate
on
apples
and
grapes.
NRDC
was
incorrect
to
assert
that
the
processing
factors
for
apples
and
grapes
were
unsupported
and
arbitrary.
The
DEEM
processing
factors
for
apple
juice
and
grape
juice
used
for
this
action
and
the
earlier
bifenazate
tolerance
action
are
based
on
data
from
processing
studies.
In
this
action,
the
Agency
used
DEEM
(
ver
7.73)
default
processing
factors
when
processing
studies
were
not
available.
These
default
factors
are
worst
case
assumptions
regarding
pesticide
partitioning
into
component
commodity
fractions.
DEEM
(
ver
7.73)
default
processing
factors
assume
that
100
percent
of
the
pesticide
that
was
originally
present
in
the
commodity
is
present
in
the
processed
fractions.
This
is
a
worst
case
theoretical
concentration
factor
since
it
assumes
that
processing
does
not
result
in
any
reduction
in
pesticide
content.
iii.
Cancer.
EPA
has
classified
bifenazate
as
a
not
likely
human
carcinogen.
Therefore,
a
quantitative
cancer
dietary
exposure
and
risk
assessment
was
not
performed.
2.
Dietary
exposure
from
drinking
water.
The
Agency
lacks
sufficient
monitoring
exposure
data
to
complete
a
comprehensive
dietary
exposure
analysis
and
risk
assessment
for
bifenazate
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
bifenazate.
The
Agency
uses
the
FQPA
Index
Reservoir
Screening
Tool
(
FIRST)
or
the
Pesticide
Root
Zone
model/
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
screeninglevel
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
high­
end
runoff
scenario
for
pesticides.
FIRST
and
PRZM/
EXAMS
incorporate
an
index
reservoir
environment,
and
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
screen
for
sorting
out
pesticides
for
which
it
is
unlikely
that
drinking
water
concentrations
would
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
bifenazate
they
are
further
discussed
in
the
aggregate
risks
in
Unit
III.
E.
Parent
bifenazate
degrades
rapidly
in
aerobic
soil
conditions
with
a
half­
life
of
approximately
30
minutes.
The
first
degradate
formed
(
D3598
(
diazinecarboxylic
acid,
2­(
4­
methoxy­
1,1'­
biphenyl­
3­
yl)
(
half­
life
of
7
hours))
was
reported
in
a
concentration
of
95%
of
the
applied
radioactivity.
D3598
degrades
to
D1989
(
4­
methylethylester)
(
reported
at
a
maximum
of
26%
of
the
applied
radioactivity),
which
is
moderately
persistent
with
an
EPAcalculated
half­
life
of
approximately
96
days.
Photodegradation
and
other
routes
of
dissipation
of
parent
bifenazate
do
not
appear
to
be
significant.
The
Agency
concluded
that
the
residue
of
concern
in
drinking
water
is
D1989.
Parent
and
D3598
were
not
included
as
a
residue
of
concern
in
drinking
water
due
to
the
short
halflives
of
these
compounds
and
the
lack
of
an
acute
dietary
endpoint
(
toxicity
of
D3598
is
assumed
to
be
equivalent
to
bifenazate).
Since
ground
or
surface
water
monitoring
data
to
calculate
a
quantitative
aggregate
exposure
are
not
available,
EPA
provided
Tier
I
ground
(
SCI­
GROW)
and
surface
water
(
FIRST)
EECs
for
D1989.
Both
models
were
conducted
using
the
strawberry
application
scenario
(
one
application
at
0.75
lbs
ai/
acre;
highest
registered/
proposed
application
rate).
The
resulting
ground
and
surface
water
chronic
EECs
are
<
0.001
ppb
and
6.4
ppb,
respectively.
In
its
objections
to
a
separate
bifenazate
tolerance
action,
NRDC
asserts
that
EPA
failed
to
complete
an
assessment
of
drinking
water
exposure
to
bifenazate
degradates.
As
stated
in
the
Federal
Register
final
rule
of
February
1,
2002,
and
restated
in
this
document,
EPA
considered
the
environmental
persistence
of
bifenazate
and
its
two
major
metabolites
D3598
and
D1989.
Aqueous
photolysis
and
soil
metabolism
studies
demonstrated
that
the
parent
bifenazate
and
the
D3598
degradate
quickly
metabolize
under
aerobic
soil
conditions.
Noting
the
lack
of
persistence
of
these
two
compounds
and
the
absence
of
any
acute
dietary
endpoint,
EPA
focused
its
drinking
water
exposure
assessment
for
bifenazate
on
the
degradate
(
D1989)
that
had
a
possibility
of
being
present
in
drinking
water.
Accordingly,
NRDC
is
incorrect
to
assert
that
potential
exposure
to
bifenazate
degredates
in
drinking
water
was
not
assessed
by
EPA.
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).
In
its
objections
to
a
separate
bifenazate
tolerance
action,
NRDC
asserts
that
EPA
failed
to
assess
and
incorporate
residential
uses
as
a
source
of
aggregate
exposure.
In
the
current
risk
assessment,
EPA
calculated
short­
term
residential
risks
to
homeowner
applicators.

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Rules
and
Regulations
However,
the
Agency
concluded
that
no
significant
post­
application
exposure
is
aniticipated
from
landscape
ornamentals;
therefore,
no
residential
post­
application
assessment
was
conducted.
Bifenazate
is
currently
registered
for
use
on
the
following
residential
nondietary
sites:
Commercial
application
to
ornamental
plants
(
including
bedding
plants,
flowering
plants,
foliage
plants,
bulb
crops,
perennials,
trees
and
shrubs;
not
turf)
and
all
fruit
trees
which
will
not
bear
fruit
for
a
minimum
of
12
months.
The
registrant
has
proposed
an
amendment
to
the
Floramite
(
EPA
Reg.
No.
400
 
508)
label
to
permit
application
to
home
ornamental
plants
and
fruit
trees
that
will
not
bear
fruit
within
12
months
by
residents/
homeowners.
The
risk
assessment
was
conducted
using
the
following
residential
exposure
assumptions:
EPA
anticipates
only
short­
term
dermal
and
short­
term
inhalation
exposure
for
the
residential
handler
(
applicator).
The
proposed
formulation
is
appropriate
for
application
via
pump
up
sprayers,
garden
hose­
end
sprayers
or
similar
homeowner
pesticide
devices.
A
larger
area
per
day
may
be
treated
with
a
hoseend
sprayer
than
with
a
pump
up
compressed
air
sprayer,
which
in
turn
results
in
possibly
greater
contact
with
the
active
ingredient
per
day.
Therefore,
exposure
from
a
hose­
end
sprayer
is
assessed
rather
than
that
of
a
compressed
air
sprayer.
For
the
treatment
of
shrubs
and
ornamentals,
EPA
assume
100
gallons
of
finish
spray
are
applied
per
day.
The
unit
exposure
value
for
a
residential
handler
using
open
pour
mixing/
loading
for
a
garden
hose­
end
sprayer
is
11
mg/
lb
handled
(
dermal)
and
0.013
mg/
lb
handled
(
inhalation).
Exposures
were
calculated
using
the
Agency's
draft
Residential
Standard
Operating
Procedures.
The
highest
label
rate
of
application
is
8
fl
oz
product/
100
gal
water.
2.0
lb
ai/
gal
÷
128
fl
oz/
gal
=
0.015625
lb
ai/
fl
oz.
(
8
fl
oz/
100
gal)(
100
gal/
day)(
0.015625
lb
ai/
fl
oz)
=
0.125
lb
ai/
day
i.
Dermal
Exposure
Assessment
and
MOE.
((
11.0
mg
ai/
lb
handled)(
0.125
lb
ai
handled/
day))
÷
70
kg
bw
=
0.019
mg/
kg/
day
MOE
=
NOAEL
÷
ADD
=
80
mg/
kg/
day
÷
0.019
mg/
kg
bw/
day
=
4,200
ii.
Inhalation
Exposure
Assessment
and
MOE.
((
0.013
mg
ai/
lb
handled)(
0.125
lb
ai
handled/
day))
÷
70
kg
bw
=
0.0000232
mg/
kg/
day
MOE
=
NOAEL
÷
ADD
=
10
mg/
kg/
day
÷
0.0000232
mg/
kg/
day
=
430,000
MOEs
are
combined
for
the
dermal
and
inhalation
routes
of
exposure
since
the
short
term
toxicological
effects
are
the
same
(
reduced
body
weight
gain
and
food
consumption).
iii.
Combined
MOE.
combined
MOE
=
1
÷
((
1
÷
MOEdermal)
+
(
1
÷
MOEinhalation)
=
4,200
An
MOE
of
100
is
adequate
to
protect
a
residential
handler
under
the
circumstances
described.
The
estimated
MOE
is
>
100
therefore
this
use
is
not
of
concern.
4.
Cumulative
effects
from
substances
with
a
common
mechanism
of
toxicity.
Section
408(
b)(
2)(
D)(
v)
of
the
FFDCA
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
bifenazate
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
bifenazate
and
any
other
substances
and
bifenazate
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
bifenazate
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
website
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.
There
is
no
indication
of
qualitative
or
quantitative
increased
susceptibility
of
rats
and
rabbits
during
in
utero
exposure
or
post­
natal
exposure
based
on
developmental
toxicity
and
reproductive
toxicity
studies
performed
with
bifenazate.
3.
Conclusion.
There
is
a
complete
toxicity
data
base
for
bifenazate
and
exposure
data
are
complete
or
are
estimated
based
on
data
that
reasonably
accounts
for
potential
exposures.
EPA
determined
that
the
10X
SF
to
protect
infants
and
children
should
be
reduced
to
1X
for
the
following
reasons:
Acceptable
developmental
toxicity
studies
in
the
rat
and
the
rabbit
are
available,
as
is
an
acceptable
2­
generation
reproduction
study
in
the
rat
and
there
is
no
indication
of
qualitative
or
quantitative
increased
susceptibility
of
rats
and
rabbits
to
in
utero
or
postnatal
exposure.
A
developmental
neurotoxicity
study
is
not
required
for
bifenazate.
The
dietary
(
food
and
water)
and
non­
dietary
(
residential)
exposure
assessments
are
not
expected
to
underestimate
the
potential
exposures
for
infants
and
children
from
the
use
of
bifenazate.

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
Office
of
Water
are
used
to
calculate
DWLOCs:
2
liter
(
L)/
70
kg
(
adult
male),
2L/
60
kg
(
adult
female),
and
1L/
10
kg
(
child).
Default
body
weights
and
drinking
water
consumption
values
vary
on
an
individual
basis.
This
variation
will
be
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26,
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and
Regulations
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
groundwater
are
less
than
the
calculated
DWLOCs,
OPP
concludes
with
reasonable
certainty
that
exposures
to
the
pesticide
in
drinking
water
(
when
considered
along
with
other
sources
of
exposure
for
which
OPP
has
reliable
data)
would
not
result
in
unacceptable
levels
of
aggregate
human
health
risk
at
this
time.
Because
OPP
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,
OPP
will
reassess
the
potential
impacts
of
residues
of
the
pesticide
in
drinking
water
as
a
part
of
the
aggregate
risk
assessment
process.
1.
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.
Bifenazate
is
not
expected
to
pose
an
acute
risk
to
humans.
2.
Chronic
risk.
Using
the
exposure
assumptions
described
in
this
unit
for
chronic
exposure,
EPA
has
concluded
that
exposure
to
bifenazate
from
food
will
utilize
24%
of
the
cPAD
for
the
U.
S.
population,
59%
of
the
cPAD
for
all
infants
<
1
year
old,
85%
of
the
cPAD
for
children
1
 
2
years
old
(
the
most
highly
exposed
population
subgroup),
and
17%
of
the
cPAD
for
females
13
 
49
years
old.
Based
on
the
use
pattern,
chronic
residential
exposure
to
residues
of
bifenazate
is
not
expected.
In
addition,
there
is
potential
for
chronic
dietary
exposure
to
bifenazate
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
3
of
this
unit:

TABLE
3.
 
AGGREGATE
RISK
ASSESSMENT
FOR
CHRONIC
(
NON­
CANCER)
EXPOSURE
TO
BIFENAZATE
Population
Subgroup
cPAD
mg/
kg/
day
%
cPAD
(
Food)
Surface
Water
EEC
(
ppb)
Ground
Water
EEC
(
ppb)
Chronic
DWLOC
(
ppb)

U.
S.
population
0.01
24
6.4
<
0.001
260
All
Infants
(<
1
year
old)
0.01
59
6.4
<
0.001
40
Children
(
1
 
2
years
old)
0.01
85
6.4
<
0.001
15
Females
(
13
 
49
years
old)
0.01
17
6.4
<
0.001
250
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).
In
its
objections
to
a
separate
bifenazate
tolerance
action,
NRDC
claims
that
residential
short­
and
intermediate­
term
risk
assessments
are
data
gaps
for
bifenazate.
In
the
current
risk
assessment,
EPA
calculated
short­
term
residential
risks
to
homeowner
applicators.
However,
the
Agency
concluded
that
no
significant
postapplication
exposure
is
aniticipated
from
landscape
ornamentals;
therefore,
no
residential
post­
application
assessment
was
conducted.
In
addition,
intermediate­
term
aggregate
exposure
(
30
days
to
6
months)
is
not
expected
since
homeowner
exposure
is
not
expected
to
exceed
1
to
30
days.
Bifenazate
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
bifenazate.
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
2,069
for
the
U.
S.
population;
2,418
for
youth
13
 
19
years
old;
2,429
for
adults
20
 
49
years
old;
2,467
for
females
13
 
49
years
old;
and
2,377
for
adults
50+
years
old.
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
bifenazate
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
4
of
this
unit:

TABLE
4.
 
AGGREGATE
RISK
ASSESSMENT
FOR
SHORT­
TERM
EXPOSURE
TO
BIFENAZATE
Population
Subgroup
Aggregate
MOE
(
Food
+
Residential
Aggregate
Level
of
Concern
(
LOC)
Surface
Water
EEC
(
ppb)
Ground
Water
EEC
(
ppb)
Short­
Term
DWLOC
(
ppb)

U.
S.
population
2,100
100
6.4
<
0.001
3,300
Youth
13
 
19
years
old
2,400
100
6.4
<
0.001
2,900
Adults
20
 
49
years
old
2,400
100
6.4
<
0.001
3,400
Females
13
 
49
year
old
2,500
100
6.4
<
0.001
2,900
Adults
50+
years
old
2,400
100
6.4
<
0.001
3,400
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Rules
and
Regulations
4.
Aggregate
cancer
risk
for
U.
S.
population.
Bifenazate
is
classified
as
not
likely
to
be
a
human
carcinogen.
The
Agency
concludes
that
bifenazate
is
not
expected
to
pose
a
cancer
risk
to
humans.
5.
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
bifenazate
residues.

IV.
Other
Considerations
A.
Analytical
Enforcement
Methodology
1.
Plant.
The
enforcement
method
for
plant
tolerances
associated
with
these
petitions
is
method
UCC
 
D2341,
which
uses
high
pressure
liquid
chromatography
with
an
oxidative
coulometric
electrochemical
detector.
2.
Livestock.
The
enforcement
method
for
animal
products
utilizes
high
pressure
liquid
chomatography
with
oxidative
coulometric
electrochemical
detection.
3.
Multiresidue
method.
Multiresidue
Enforcement
Method
Protocol
C
has
been
shown
to
be
adequate
for
enforcing
these
tolerances.
These
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;
e­
mail
address:
residuemethods@
epa.
gov.

B.
International
Residue
Limits
Canada,
Codex,
and
Mexico
do
not
have
maximum
residue
limits
(
MRLs)
for
residues
of
bifenazate
in/
on
the
proposed
crops.
Therefore,
harmonization
is
not
an
issue.

V.
Conclusion
Therefore,
tolerances
are
established
for
combined
residues
of
bifenazate,
and
diazinecarboxylic
acid;
2­(
4­
methoxy­
[
1,1'­
biphenyl]­
3­
yl),
1­
methylethyl
ester
(
expressed
as
bifenazate)
in
or
on
almond,
hulls
at
15
ppm;
nut,
tree,
group
14
at
0.20
ppm;
okra
at
2.0
ppm;
peppermint,
tops
at
25
ppm;
pistachio
at
0.20
ppm;
spearmint,
tops
at
25
ppm;
vegetable,
cucurbit,
group
9
at
0.75
ppm;
and
vegetable,
fruiting,
group
8
at
2.0
ppm,
and
combined
residues
of
bifenazate;
diazinecarboxylic
acid,
(
expressed
as
bifenazate);
1,1'­
biphenyl,
4­
ol;
and
1,1'­
biphenyl,
4­
oxysulfonic
acid
(
expressed
as
1,1'­
biphenyl,
4­
ol)]
in
[
meat
and
meat
byproducts
of
cattle,
goat,
hog,
horse,
and
sheep
at
0.02
ppm
and
milk
at
0.02
ppm.
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
 
2003
 
0297
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
November
25,
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,
P.
O.
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
 
2003
 
0297,
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
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26,
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/
Rules
and
Regulations
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
tolerances
and
exemptions
that
are
established
on
the
basis
of
a
petition
under
section
408(
d)
of
the
FFDCA,
such
as
the
tolerances
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:
September
15,
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
180.572
is
amended:
i.
In
paragraph
(
a)(
1)
by
revising
the
introductory
text
and
alphabetically
adding
commodities
to
the
table;
ii.
By
revising
paragraph
(
a)(
2);
and
iii.
In
paragraph
(
b),
by
revising
the
introductory
text
and
removing
the
commodities
``
Hop''
and
``
Pear''
from
the
table.
The
amendments
read
as
follows:

§
180.572
Bifenazate;
tolerances
for
residues.

(
a)
General.
(
1)
Tolerances
are
established
for
combined
residues
of
bifenazate
(
1­
methylethyl
2­(
4­
methoxy[
1,1'­
biphenyl]­
3­
yl)
hydrazinecarboxylate)
and
diazinecarboxylic
acid,
2­(
4­
methoxy­
[
1,1'­
biphenyl]­
3­
yl),
1­
methylethyl
ester
(
expressed
as
bifenazate)
in
or
on
the
following
food
commodities:

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Federal
Register
/
Vol.
68,
No.
187
/
Friday,
September
26,
2003
/
Rules
and
Regulations
Commodity
Parts
per
million
Almond,
hulls
................
15
*
*
*
*
*

Nut,
tree,
group
14
.......
0.20
Okra
..............................
2.0
*
*
*
*
*

Peppermint,
tops
...........
25
Pistachio
.......................
0.20
*
*
*
*
*

Spearmint,
tops
.............
25
*
*
*
*
*

Vegetable,
cucurbit,
group
9.
0.75
Vegetable,
fruiting,
group
8.
2.0
(
2)
Tolerances
are
established
for
combined
residues
of
bifenazate
(
1­
methylethyl
2­(
4­
methoxy[
1,1'­
biphenyl]­
3­
yl)
hydrazinecarboxylate);
diazinecarboxylic
acid,
2­(
4­
methoxy­
[
1,1'­
biphenyl]­
3­
yl),
1­
methylethyl
ester
(
expressed
as
bifenazate);
1,1'­
biphenyl,
4­
ol;
and
1,1'­
biphenyl,
4­
oxysulfonic
acid
(
expressed
as
1,1'­
biphenyl,
4­
ol)
in
or
on
the
following
food
commodities:

Commodity
Parts
per
million
Cattle,
meat
..................
0.02
Cattle,
meat
byproducts
0.02
Goat,
meat
....................
0.02
Goat,
meat
byproducts
0.02
Hog,
meat
.....................
0.02
Hog,
meat
byproducts
...
0.02
Horse,
meat
..................
0.02
Horse,
meat
byproducts
0.02
Milk
................................
0.02
Sheep,
meat
.................
0.02
Sheep,
meat
byproducts
0.02
(
b)
Section
18
emergency
exemptions.
Time­
limited
tolerances
are
established
for
combined
residues
of
bifenazate
(
1­
methylethyl
2­(
4­
methoxy[
1,1'­
biphenyl]­
3­
yl)
hydrazinecarboxylate)
and
diazinecarboxylic
acid,
2­(
4­
methoxy­[
1,1'­
biphenyl]­
3­
yl),
1­
methylethyl
ester
(
expressed
as
bifenazate)
in
connection
with
use
of
the
pesticide
under
section
18
emergency
exemptions
granted
by
EPA.
The
tolerances
will
expire
and
are
revoked
on
the
dates
specified
in
the
following
table.
*
*
*
*
*

[
FR
Doc.
03
 
24370
Filed
9
 
25
 
03;
8:
45
am]

BILLING
CODE
6560
 
50
 
S
ENVIRONMENTAL
PROTECTION
AGENCY
40
CFR
Part
180
[
OPP
 
2003
 
0304];
FRL
 
7325
 
8]

Thiacloprid;
Pesticide
Tolerances
AGENCY:
Environmental
Protection
Agency
(
EPA).
ACTION:
Final
rule.

SUMMARY:
This
regulation
establishes
tolerances
for
combined
residues
of
thiacloprid
([
3­[(
6­
chloro­
3­
pridinyl)
methyl]­
2­
thiazolidinylidene]
cyanamide)
and
metabolites
retaining
the
thiazolidine
ring
intact,
measured
and
expressed
in
terms
of
thiacloprid,
per
se,
in
or
on
apple,
wet
pomace;
cotton,
undelinted
seed;
cotton,
gin
by­
products;
fruit,
pome
group
11;
fat,
meat,
liver,
kidney
and
meat
by­
products
of
cattle,
sheep,
goat
and
horse;
and
milk.
Bayer
CropScience
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
September
26,
2003.
Objections
and
requests
for
hearings,
identified
by
docket
ID
number
OPP
 
2003
 
0304],
must
be
received
on
or
before
November
25,
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:
Marilyn
Mautz,
Registration
Division,
7505C,
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001;
telephone
number:
703
305
 
6785;
e­
mail
address:
mautz.
marilyn@
epa.
gov.

SUPPLEMENTARY
INFORMATION:

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

You
may
be
potentially
affected
by
this
action
if
you
are
an
agricultural
producer,
food
manufacturer,
or
pesticide
manufacturer.
Potentially
affected
entities
may
include,
but
are
not
limited
to:
 
Crop
production
(
NAICS
111)
 
Animal
production
(
NAICS
112)
 
Food
manufacturing
(
NAICS
311)
 
Pesticide
manufacturing
(
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
 
2003
 
0304.
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
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