27729
Federal
Register
/
Vol.
68,
No.
98
/
Wednesday,
May
21,
2003
/
Rules
and
Regulations
Reduction
Act
of
1995
(
44
U.
S.
C.
3501
 
3520).

Federalism
A
rule
has
implications
for
federalism
under
Executive
Order
13132,
Federalism,
if
it
has
a
substantial
direct
effect
on
State
or
local
governments
and
would
either
preempt
State
law
or
impose
a
substantial
direct
cost
of
compliance
on
them.
We
have
analyzed
this
rule
under
that
Order
and
have
determined
that
it
does
not
have
implications
for
federalism.

Unfunded
Mandates
Reform
Act
The
Unfunded
Mandates
Reform
Act
of
1995
(
2
U.
S.
C.
1531
 
1538)
requires
Federal
agencies
to
assess
the
effects
of
their
discretionary
regulatory
actions.
In
particular,
the
Act
addresses
actions
that
may
result
in
the
expenditure
by
a
State,
local,
or
tribal
government,
in
the
aggregate,
or
by
the
private
sector
of
$
100,000,000
or
more
in
any
one
year.
Though
this
rule
will
not
result
in
such
an
expenditure,
we
do
discuss
the
effects
of
this
rule
elsewhere
in
this
preamble.

Taking
of
Private
Property
This
rule
will
not
effect
a
taking
of
private
property
or
otherwise
have
taking
implications
under
Executive
Order
12630,
Governmental
Actions
and
Interference
with
Constitutionally
Protected
Property
Rights.

Civil
Justice
Reform
This
rule
meets
applicable
standards
in
sections
3(
a)
and
3(
b)(
2)
of
Executive
Order
12988,
Civil
Justice
Reform,
to
minimize
litigation,
eliminate
ambiguity,
and
reduce
burden.

Protection
of
Children
We
have
analyzed
this
rule
under
Executive
Order
13045,
Protection
of
Children
from
Environmental
Health
Risks
and
Safety
Risks.
This
rule
is
not
an
economically
significant
rule
and
does
not
create
an
environmental
risk
to
health
or
risk
to
safety
that
may
disproportionately
affect
children.

Indian
Tribal
Governments
This
rule
does
not
have
tribal
implications
under
Executive
Order
13175,
Consultation
and
Coordination
with
Indian
Tribal
Governments,
because
it
does
not
have
a
substantial
direct
effect
on
one
or
more
Indian
tribes,
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.
Energy
Effects
We
have
analyzed
this
rule
under
Executive
Order
13211,
Actions
Concerning
Regulations
That
Significantly
Affect
Energy
Supply,
Distribution,
or
Use.
We
have
determined
that
it
is
not
a
``
significant
energy
action''
under
that
order
because
it
is
not
a
``
significant
regulatory
action''
under
Executive
Order
12866
and
is
not
likely
to
have
a
significant
adverse
effect
on
the
supply,
distribution,
or
use
of
energy.
The
Administrator
of
the
Office
of
Information
and
Regulatory
Affairs
has
not
designated
it
as
a
significant
energy
action.
Therefore,
it
does
not
require
a
Statement
of
Energy
Effects
under
Executive
Order
13211.

Environment
We
have
analyzed
this
rule
under
Commandant
Instruction
M16475.1D,
which
guides
the
Coast
Guard
in
complying
with
the
National
Environmental
Policy
Act
of
1969
(
NEPA)
(
42
U.
S.
C.
4321
 
4370f),
and
have
concluded
that
there
are
no
factors
in
this
case
that
would
limit
the
use
of
categorical
exclusion
under
section
2.
B.
2
of
the
Instruction.
Therefore,
this
rule
is
categorically
excluded,
under
figure
2
 
1
paragraph
(
34)(
g),
of
the
instruction,
from
further
environmental
documentation
because
this
rule
is
not
expected
to
result
in
any
significant
environmental
impact
as
described
in
NEPA.
A
final
``
Environmental
Analysis
Check
List''
and
a
final
``
Categorical
Exclusion
Determination''
are
available
in
the
docket
where
indicated
under
ADDRESSES.

List
of
Subjects
in
33
CFR
Part
165
Harbors,
Marine
safety,
Navigation
(
water),
Reporting
and
recordkeeping
requirements,
Security
measures,
Vessels,
Waterways.


For
the
reasons
discussed
in
the
preamble,
the
Coast
Guard
amends
33
CFR
part
165
as
follows:

PART
165
 
REGULATED
NAVIGATION
AREAS
AND
LIMITED
ACCESS
AREAS

1.
The
authority
citation
for
part
165
continues
to
read
as
follows:

Authority:
33
U.
S.
C.
1231;
50
U.
S.
C.
191,
33
CFR
1.05
 
1(
g),
6.04
 
1,
6.04
 
6,
and
160.5;
Department
of
Homeland
Security
Delegation
No.
0170.


2.
From
8
a.
m.
on
May
11,
2003
through
8
p.
m.
on
November
15,
2003
add
temporary
§
165.
T09
 
214
to
read
as
follows:

§
165.
T09
 
214
Regulated
Navigation
Area;
Des
Plaines
River,
Joliet,
Illinois
(
a)
Regulated
navigation
area.
The
following
waters
are
a
Regulated
Navigation
Area
(
RNA):
All
portions
of
the
Des
Plaines
River
between
mile
287.3
(
McDonough
St.
Bridge)
and
mile
288.7
(
Ruby
Street
Bridge).
(
b)
Applicability.
This
section
applies
to
operators
of
all
southbound
tows
transiting
beneath
the
Jefferson
Street
Bridge
(
mile
287.9),
Joliet,
Illinois
with
barge
configurations
of
over
89
feet
in
overall
width
and
more
than
800
feet
in
length.
(
c)
Regulations.
(
1)
All
southbound
tows
to
which
this
section
applies
must
use
an
assist
tug
when
transiting
through
the
RNA.
(
2)
The
general
regulations
contained
in
33
CFR
165.13
apply
to
this
section.
(
3)
Deviation
from
this
section
is
prohibited
unless
specifically
authorized
by
the
Commander,
Ninth
Coast
Guard
District
or
his
designated
representatives.
Designated
representatives
include
the
Captain
of
the
Port
Chicago.

Dated:
May
9,
2003.
Ronald
F.
Silva,
Rear
Admiral,
Coast
Guard,
Commander,
Ninth
Coast
Guard
District.
[
FR
Doc.
03
 
12687
Filed
5
 
20
 
03;
8:
45
am]

BILLING
CODE
4910
 
15
 
P
ENVIRONMENTAL
PROTECTION
AGENCY
40
CFR
Part
180
[
OPP
 
2003
 
0163;
FRL
 
7306
 
1]

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

SUMMARY:
This
regulation
establishes
a
tolerance
for
combined
residues
of
pyraflufen­
ethyl
in
or
on
cotton.
Nichino
America
Incorporated
requested
this
tolerance
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
May
21,
2003.
Objections
and
requests
for
hearings,
identified
by
docket
ID
number
OPP
 
2003
 
0163,
must
be
received
on
or
before
July
21,
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:
Joanne
I.
Miller,
Registration
Division
(
7505C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,

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/
Vol.
68,
No.
98
/
Wednesday,
May
21,
2003
/
Rules
and
Regulations
DC
20460
 
0001;
telephone
number:
(
703)
305
 
6224;
e­
mail
address:
miller.
joanne@
epa.
gov.

SUPPLEMENTARY
INFORMATION:

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

You
may
be
potentially
affected
by
this
action
if
you
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
 
0163.
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
November
20,
2002
(
67
FR
70073)
(
FRL
 
7184
 
7),
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
a
pesticide
petition
(
1F6428)
by
Nichino
America
Incorporated,
4550
New
Linden
Hill
Road,
Suite
501,
Wilmington,
DE
19808.
That
notice
included
a
summary
of
the
petition
prepared
by
Nichino
America
Incorporated,
the
registrant.
There
were
no
comments
received
in
response
to
the
notice
of
filing.
The
petition
requested
that
40
CFR
180.585
be
amended
by
establishing
tolerances
for
combined
residues
of
the
herbicide
pyraflufen­
ethyl
(
ethyl
2­
chloro­
5­(
4­
chloro­
5­
difluoromethoxy­
1­
methyl­
1H­
pyrazol­
3­
yl)­
4­
fluorophenoxyacetate)
and
its
acid
metabolite,
E­
1
(
2­
chloro­
5­(
4­
chloro­
5­
difluoromethoxy­
1­
methyl­
1H­
pyrazol­
3­
yl)­
4­
fluorophenoxyacetic
acid),
expressed
as
the
ester
equivalent
in
or
on
cotton
undelinted
seed
at
0.05
parts
per
million
(
ppm)
and
cotton
gin
byproduct
at
1.5
ppm.
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
November
26,
1997)
(
62
FR
62961)
(
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
residues
of
pyraflufen­
ethyl
on
cotton
undelinted
seed
at
0.04
ppm
and
cotton
gin
byproduct
at
1.5
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
pyraflufen­
ethyl
are
discussed
in
Table
1
of
this
unit
as
well
as
the
no
observed
adverse
effect
level
(
NOAEL)
and
the
lowest
observed
adverse
effect
level
(
LOAEL)
from
the
toxicity
studies
reviewed.

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Vol.
68,
No.
98
/
Wednesday,
May
21,
2003
/
Rules
and
Regulations
TABLE
1.
 
SUBCHRONIC,
CHRONIC,
AND
OTHER
TOXICITY
Guideline
No.
Study
Type
Results
870.3100
90
 
day
oral
toxicity
in
rats
NOAEL
=
5,000
parts
per
million
(
ppm)
(
456
 
499
milligrams
kilograms/
day
(
mg/
kg/
day)).
LOAEL
=
15,000
ppm
(
1,489
 
1,503
mg/
kg/
day)
based
on
clinical
signs,
death,
effects
on
erythrocytes,
changes
in
clinical
chemicals
for
liver
function
and
splenomegaly.

870.3150
90
 
day
oral
toxicity
in
dogs
NOAEL
=
1,000
mg/
kg/
day.
LOAEL
not
established,
no
effects
observed.

870.3200
28
 
Day
dermal
toxicity
in
rats
NOAEL
=
1,000
mg/
kg/
day.
LOAEL
not
established;
no
effects
observed.

870.3700
Prenatal
developmental
in
rats
Maternal
NOAEL
 
1,000
mg/
kg/
day
Maternal
LOAEL
not
determined;
no
effects
observed.
Developmental
NOAEL
 
1,000
mg/
kg/
day.
Developmental
LOAEL
not
determined;
no
effects
observed.

870.3700
Prenatal
developmental
in
rabbits
Maternal
NOAEL
=
20
mg/
kg/
day.
Maternal
LOAEL=
60
mg/
kg/
day
based
on
mortality.
Developmental
=
60
mg/
kg/
day.
Developmental
LOAEL
=
150
mg/
kg/
day
based
on
increased
incidence
of
abortion.

870.3800
Reproduction
and
fertility
effects
Parental
NOAEL
=
1,000
ppm
(
70.8
 
82.3
mg/
kg/
day
(
M);
80.1
 
91.2
(
F).
Parental
LOAEL
=
10,000
ppm
(
721
 
844
and
813
 
901
mg/
kg/
day)
based
on
decreased
body
weight
(
bwt)
and
bwt
gains
of
F0
and
F1(
M)
and
F1(
F),
gross
and
microscopic
liver
lesions
of
(
M)
and
(
F)­
both
generations.
Reproductive
NOAEL
 
10,000
ppm
(
721
 
844
and
813
 
901
mg/
kg/
day).
Reproductive
LOAEL
not
determined;
no
effects
observed.
Offspring
NOAEL
=
1,000
ppm
(
70.8
 
82.3
mg/
kg/
day
(
M);
80.1
 
91.2
(
F).
Offspring
LOAEL
=
10,000
ppm
(
721
 
844
and
813
 
901
mg/
kg/
day)
based
on
decreased
bwt
and
bwt
gains
of
the
F1
and
F2
pups.

870.4100
Chronic
toxicity
in
dogs
NOAEL
 
1,000
mg/
kg/
day.
LOAEL
not
determined;
no
effects
observed.

870.4200
Carcinogenicity
in
mice
NOAEL
=
200
ppm
(
20.99
mg/
kg/
day
(
M);
19.58
mg/
kg/
day
(
F).
LOAEL
=
1,000
ppm
(
109.7
mg/
kg/
day
(
M);
98.3
mg/
kg/
day
(
F)
based
on
liver
toxicity,
hepatocellular
tumors
at
5,000
ppm;
possibly
hemangioma/
hemangioasarcomas.

870.4300
Chronic
toxicity
in
rodents/
carcinogenicity
in
rats
NOAEL
=
2,000
ppm
(
86.7
mg/
kg/
day
(
M);
111.5
mg/
kg/
day
(
F).
LOAEL
=
10,000
ppm
(
468.1
mg/
kg/
day
(
M);
578.5
mg/
kg/
day
(
F)
based
on
decreased
bwt
and
bwt
gain
in
males
and
microcytic
anemia,
liver
lesions
and
kidney
toxicity
(
both
sexes);
possible
increase
pheochromocytomas
in
females

870.5100
Gene
nutation
Non­
mutagenic
when
tested
up
to
5,000
µ
g/
plate,
in
presence
and
absence
of
metabolic
activation
(
S9­
mix),
in
S.
typhimurium
strains
TA98,
TA100,
TA1535,
TA1537
and
TA1538
and
E.
coli
strain
WP2(
uvrA).
There
was
no
evidence
of
induced
mutant
colonies
over
background.

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21,
2003
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Rules
and
Regulations
TABLE
1.
 
SUBCHRONIC,
CHRONIC,
AND
OTHER
TOXICITY
 
Continued
Guideline
No.
Study
Type
Results
870.5300
Gene
mutation
In
mammalian
cell
gene
mutation
assays
at
the
TK
locus,
L5178Y
mouse
lymphoma
cells
cultured
in
vitro
were
exposed
to
pyraflufen­
ethyl
in
dimethylsulfoxide
(
DMOS)
in
the
absence
of
mammalian
metabolic
activation
(
S9­
mix)
and
with
S9­
mix.
Concentrations
160
µ
g/
mL
were
insoluble
cytotoxicity
was
seen
at
80
µ
g/
mL
­
S9
and
160
µ
g/
mL
+
S9.
There
was
no
increase
in
the
number
of
mutant
colonies
over
background
in
the
absence
of
S9­
mix
but
a
non­
reproducible
dose­
related
increase
in
the
number
of
mutant
colonies
was
seen
in
the
presence
of
S9­
mix.
In
mammalian
cell
gene
mutation
assays
at
the
TK
locus,
L5178Y
mouse
lymphoma
cells
cultured
in
vitro
were
exposed
to
pyraflufen­
ethyl
in
DMSO
in
the
absence
of
mammalian
metabolic
activation
(
S9­
mix)
and
with
S9­
mix.
There
was
no
evidence
of
induced
mutant
colonies
over
background
up
to
cytotoxic
concentrations
(
50
µ
g/
mL­
S9;
and
350
µ
g/
mL
+
S9.

870.5375
Chromosomal
aberration
In
a
mammalian
cell
cytogenetics
assay,
human
primary
lymphocyte
cultures
were
exposed
to
pyraflufen­
ethyl
in
DMSO
without
metabolic
activation
(
S9­
mix)
or
with
S9­
mix.
Compound
precipitation
occurred
at
2,600
µ
g/
mL
+/­
S9.
There
was
no
evidence
of
chromosomal
aberration
induction
over
background.

870.5395
Cytogenetics
In
a
CD­
1
mouse
bone
marrow
micronucleus
assay,
five
mice/
sex/
dose/
harvest
time
were
treated
via
oral
gavage
with
pyraflufen­
ethyl
in
corn
oil.
ET­
751
was
tested
to
the
limit
(
LTD)
dose
of
5,000
mg/
kg
bwt.
Signs
of
compound
toxicity
were
limited
to
piloerection,
hunched
posture
in
one
female,
and
piloerection
and
hunched
posture
in
one
male
receiving
5,000
mg/
kg.
No
bone
marrow
cytotoxicity
was
seen
at
any
dose.
There
was
no
statistically
significant
increase
in
the
frequency
of
micronucleated
polychromatic
erythrocytes
in
bone
marrow
after
any
dose
or
treatment
time.

870.5500
Bacillus
subtilis
In
a
differential
killing/
growth
inhibition
assay
in
bacteria,
strains
H17
(
rec+)
and
M45
(
rec­)
of
B.
subtilis
were
exposed
to
pyraflufen­
ethyl
in
DMSO
in
the
presence
and
absence
of
metabolic
activation
(
S9­
mix).
There
was
no
evidence
of
greater
growth
inhibition
or
cell
killing
in
repair
defective
strains
compared
to
repair
competent
strains
up
to
the
limit
of
test
material
solubility.

870.5550
Unscheduled
DNA
synthesis
(
UDS)
In
an
in
vivo/
in
vitro
UDS
assay
in
rat
hepatocytes,
pyraflufen­
ethyl
was
administered
to
five
SPF
outbred
albino
Hsd/
Ola
Sprague­
Dawley
male
rats
per
test
group
by
oral
gavage
(
four
of
the
five
rats
were
used
for
hepatocyte
culture).
No
signs
of
overt
toxicity
to
the
test
animals
or
cytotoxic
effects
to
the
target
cells
were
seen
up
to
the
LTD
(
2,000
mg/
kg).
The
mean
net
nuclear
grain
count
was
below
zero
for
both
doses
at
both
treatment
times
indicating
no
induction
of
UDS
as
tested
in
this
study.

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Vol.
68,
No.
98
/
Wednesday,
May
21,
2003
/
Rules
and
Regulations
TABLE
1.
 
SUBCHRONIC,
CHRONIC,
AND
OTHER
TOXICITY
 
Continued
Guideline
No.
Study
Type
Results
870.7485
Metabolism
and
pharmacokinetics
Pyraflufen­
ethyl
was
readily
absorbed
and
excreted
within
96
hours
following
a
single
or
repeated
oral
dose
of
5
mg/
kg
(
plasma
t1/
2
of
3
 
3.5
hours).
However,
at
a
dose
of
500
mg/
kg,
absorption
was
saturated
as
indicated
by
Cmax
values
which
did
not
reflect
the
100­
fold
dose
differential
(
2.7
 
2.8
Fg
eq/
g
for
the
low­
dose
group
and
100
 
107
Fg
eq­
hr/
g
for
the
high­
dose
group).
Following
single
or
multiple
oral
low
doses
(
5
mg/
kg)
of
pyraflufen
ethyl,
urinary
excretion
accounted
for
27
 
33%
of
the
administered
radioactivity
suggesting
that
a
multiple
exposure
regimen
did
not
affect
the
absorption/
excretion
processes
Urinary
excretion
was
reduced
to
only
5
 
7%
following
a
single
500
mg/
kg
dose.
Excretion
via
the
feces
accounted
for
the
remainder
of
the
administered
radioactivity
in
all
treatment
groups.
Analysis
of
biliary
excretion
following
a
single
5
mg/
kg
dose
showed
that
36%
of
the
administered
dose
appeared
in
the
bile.
Based
upon
the
excretion
data,
total
bioavailability
of
a
low
dose
was
approximately
56%.
Biliary
excretion
data
were
not
available
for
a
high­
dose
group
which
prevented
a
definitive
assessment
of
bioavailability.
Excretory
patterns
did
not
exhibit
gender­
related
variability.
However,
plasma
and
blood
clearance
was
more
rapid
in
females
than
in
males
as
shown
by
plasma/
blood
radioactivity
time­
course
and
the
greater
AUC
values
for
males
(
32.3
vs
18.4
Fg
eq­
hr/
g
for
the
low­
dose
group
and
2,738
vs
1,401
Fg
eq­
hr/
g
for
the
high­
dose
group).
Radioactivity
concentrations
indicated
tissue
concentrations
at
or
near
detection
limits
(
generally
<
0.01
Fg
eq/
g
and
never
exceeding
0.02
Fg
eq/
g)
at
96
hrs
postdose
for
any
tissues.
Therefore,
neither
pyraflufen­
ethyl
nor
its
metabolites
appear
to
undergo
significant
sequestration.
Tissue
burden
data
following
compound
administration
did
not
suggest
a
specific
target
beyond
those
tissues,
namely
liver
and
kidney,
which
are
associated
with
absorption
and
elimination
of
orally
administered
xenobiotics.

B.
Toxicological
Endpoints
The
dose
at
which
no
observed
adverse
effects
levels
are
(
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
observed
adverse
effects
of
levels
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.
For
dietary
risk
assessment
(
other
than
cancer)
the
Agency
uses
the
UF
to
calculate
an
acute
or
chronic
reference
dose
(
aRfD
or
cRfD)
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.
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
pyraflufen­
ethyl
used
for
human
risk
assessment
is
shown
in
Table
2:

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Rules
and
Regulations
TABLE
2.
 
SUMMARY
OF
TOXICOLOGICAL
DOSE
AND
ENDPOINTS
FOR
PYRAFLUFEN­
ETHYL
FOR
USE
IN
HUMAN
RISK
ASSESSMENT
Exposure
Scenario
Dose
(
mg/
kg/
day)
UF/
MOE
Hazard
Based
Special
FQPA
Safety
Factor
Endpoint
for
Risk
Assessment
Dietary
Risk
Assessments
Acute
dietary
Not
applicable
Not
applicable
No
adverse
effect
attributable
to
a
single
exposure
(
dose)
was
observed
in
oral
toxicity
studies,
including
the
developmental
toxicity
studies
in
rats
and
rabbits.

Chronic
dietary
NOAEL=
20
UF
=
100
Chronic
RfD
=
0.20
mg/
kg/
day
1X
Mouse
carcinogenicity.
LOAEL
=
98
mg/
kg/
day
based
on
liver
toxicity.

Incidental
oral
short­
term
(
1
 
30
days)
residential
only
NOAEL=
20
UF
=
100
MOE=
100
1X
Developmental
toxicity­
rabbit.
LOAEL
=
60
mg/
kg/
day
based
on
decreases
in
body
weight
and
food
consumption,
GI
observations
and
abortions.

Incidental
oral
intermediate­
term
(
1
 
6
months)
residential
only
NOAEL=
20
UF
=
100
MOE=
100
1X
Mouse
carcinogenicity.
LOAEL
=
98
mg/
kg/
day
based
on
liver
toxicity
at
interim
sacrifice.

Non­
Dietary
Risk
Assessments
Dermal
short­
term
and
intermediate
term
Not
applicable
Not
applicable
In
a
28­
dermal
toxicity
study
in
rats,
no
dermal
or
systemic
toxicity
was
seen
at
the
LTD
(
1,000
mg/
kg/
day).
The
physical
and
chemical
characteristics
(
e.
g.,
Kow
is
low)
indicate
that
dermal
absorption
is
not
expected
to
occur
to
any
appreciable
extent.
There
is
no
concern
for
prenatal
and/
or
postnatal
toxicity.
Therefore,
no
hazard
was
identified
and
quantification
of
dermal
risk
is
not
required.

Residential
MOE
=
not
applicable
Not
applicable
Occupational
MOE
=
not
applicable
Not
applicable
Inhalation1
short­
term
(
1
 
30
days)
Oral
NOAEL=
20
1X
Developmental
toxicity­
rabbit.
LOAEL
=
60
mg/
kg/
day
based
on
decreases
in
bwt
and
food
consumption,
GI
observations,
and
abortions.

Residential
MOE
=
100
Occupational
MOE=
100
Inhalation1
intermediate­
term
(
1
 
6
months)
Oral
NOAEL=
20
1X
Mouse
carcinogenicity.
LOAEL
=
98
mg/
kg/
day
based
on
liver
toxicity
at
interim
sacrifice.

Residential
MOE
=
100
Occupational
MOE=
100
Inhalation1
long­
term
(<
6
months)
Oral
NOAEL=
20
1X
Mouse
carcinogenicity.
LOAEL
=
98
mg/
kg/
day
based
on
liver
toxicity.

Residential
MOE
=
100
Occupational
MOE=
100
Cancer
Classification:
``
Likely
to
be
Carcinogenic
to
Humans''
by
the
oral
route
Q1*
=
3.32
x
10­
2
(
mg/
kg/
day)­
1
1­
Oral
endpoints
were
selected
because
inhalation
studies
were
unavailable.
Absorption
via
the
inhalation
route
is
presumed
to
be
equivalent
to
oral
absorption.
*
The
reference
to
the
FQPA
SF
refers
to
any
additional
SF
retained
due
to
concerns
unique
to
the
FQPA.

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/
Vol.
68,
No.
98
/
Wednesday,
May
21,
2003
/
Rules
and
Regulations
C.
Exposure
Assessment
1.
Dietary
exposure
from
food
and
feed
uses.
Tolerances
have
been
established
(
40
CFR
180.585)
for
the
combined
residues
of
pyraflufen­
ethyl
(
ethyl
2­
chloro­
5­(
4­
chloro­
5­
difluoromethoxy­
1­
methyl­
1H­
pyrazol­
3­
yl)­
4­
fluorophenoxyacetate)
and
its
acid
metabolite,
E­
1
(
2­
chloro­
5­(
4­
chloro­
5­
difluoromethoxy­
1­
methyl­
1Hpyrazol
3­
yl)­
4­
fluorophenoxyacetic
acid),
expressed
as
the
ester
equivalent
in
or
on
a
variety
of
raw
agricultural
commodities.
Risk
assessments
were
conducted
by
EPA
to
assess
dietary
exposures
from
pyraflufen­
ethyl
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
1
 
day
or
single
exposure.
No
adverse
effect
attributable
to
a
single
exposure
(
dose)
of
pyraflufen­
ethyl
was
observed
in
the
oral
toxicity
studies,
including
the
developmental
toxicity
studies
in
rats
and
rabbits.
Therefore,
EPA
did
not
identify
an
acute
dietary
endpoint
and
an
acute
dietary
assessment
was
not
performed
because
no
acute
risk
is
expected.
ii.
Chronic
exposure.
In
conducting
this
chronic
dietary
risk
assessment
the
Dietary
Exposure
Evaluation
Model
(
DEEMTM)
analysis
evaluated
the
individual
food
consumption
as
reported
by
respondents
in
the
United
State
Department
of
Agriculture
(
USDA)
nationwide
Continuing
Surveys
of
Food
Intake
by
Individuals
(
CSFII)
1989
 
1992
and
accumulated
exposure
to
the
chemical
for
each
commodity.
The
following
assumptions
were
made
for
the
chronic
exposure
assessments:
100%
crop
treated
(
PCT)
and
tolerancelevel
residues
for
pyraflufen­
ethyl
on
all
treated
crops.
This
assessment
was
Tier
I
analysis.
The
exposure
from
pyraflufen­
ethyl
residues
in
food
occupies
less
than
1%
of
the
chronic
population
adjusted
dose
(
cPAD)
for
all
population
subgroups
and
is
not
a
concern.
iii.
Cancer.
The
cancer
dietary
exposure
assessment
was
conducted
using
the
DEEM
analysis
evaluated
the
individual
food
consumption
as
reported
by
respondents
in
the
USDA
nationwide
CSFII
1989
 
1992
and
accumulated
exposure
to
the
chemical
for
each
commodity.
The
following
assumptions
were
made
for
the
cancer
assessments:
100%
PCT
and
tolerancelevel
residues
for
pyraflufen­
ethyl
on
all
treated
crops.
The
estimated
exposure
to
the
U.
S.
population
(
total)
to
pyraflufenethyl
is
2
x
10­
5
mg/
kg/
day.
Applying
the
Q1*
of
0.0332
(
mg/
kg/
day)­
1
to
the
exposure
value
results
in
a
cancer
risk
estimate
of
6.6
x
10­
7.
Therefore,
the
lifetime
cancer
risk
to
the
U.
S.
population
is
below
EPA's
level
of
concern.
2.
Dietary
exposure
from
drinking
water.
The
Agency
lacks
sufficient
monitoring
exposure
data
to
complete
a
comprehensive
dietary
exposure
analysis
and
risk
assessment
for
pyraflufen­
ethyl
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
chemical
and
physical
characteristics
of
pyraflufen­
ethyl.
The
Agency
uses
the
First
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
Screening
Concentration
in
Ground
Water
(
SCI­
GROW)
model
is
used
to
predict
pesticide
concentrations
in
shallow
ground
water.
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.
While
both
FIRST
and
PRZM/
EXAMS
incorporate
an
index
reservoir
environment,
the
PRZM/
EXAMS
model
includes
a
PCT
crop
area
factor
as
an
adjustment
to
account
for
the
maximum
PCT
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
percent
referance
dose
(%
RfD)
or
percent
population
adjusted
dose
(%
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
pyraflufen­
ethyl
they
are
further
discussed
in
the
aggregate
risk
sections
below.
Based
on
the
FIRST
and
SCI­
GROW
models
the
EECs
of
pyraflufen­
ethyl
for
acute
exposures
are
estimated
to
be
1.25
parts
per
billion
(
ppb)
for
surface
water
and
0.002
ppb
for
ground
water.
The
EECs
for
chronic
exposures
are
estimated
to
be
0.28
ppb
for
surface
water
and
0.002
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).
Pyraflufen­
ethyl
is
currently
registered
for
use
on
the
following
residential
non­
dietary
sites:
Airports,
nurseries,
ornamental
turf,
golf
courses,
roadsides,
and
railroads.
The
risk
assessment
was
conducted
using
the
following
residential
exposure
assumptions:
adults
and
children
may
be
exposed
to
residues
of
pyraflufenethyl
through
postapplication
contact
with
treated
areas
which
may
include
residential/
recreational
areas.
4.
Cumulative
exposure
to
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
pyraflufen­
ethyl
has
a
common
mechanism
of
toxicity
with
other
substances
or
how
to
include
this
pesticide
in
a
cumulative
risk
assessment.
Unlike
other
pesticides
for
which
EPA
has
followed
a
cumulative
risk
approach
based
on
a
common
mechanism
of
toxicity,
pyraflufen­
ethyl
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
pyraflufen­
ethyl
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
final
rule
for
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/
Vol.
68,
No.
98
/
Wednesday,
May
21,
2003
/
Rules
and
Regulations
Bifenthrin
Pesticide
Tolerances
(
62
FR
62961,
November
26,
1997).

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
(
MOS)
for
infants
and
children
in
the
case
of
threshold
effects
to
account
for
prenatal
and
postnatal
toxicity
and
the
completeness
of
the
database
on
toxicity
and
exposure
unless
EPA
determines
that
a
different
MOS
will
be
safe
for
infants
and
children.
MOS
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
evidence
of
increased
susceptibility
of
rat
or
rabbit
fetuses
following
in
utero
exposure
in
the
developmental
studies
with
pyraflufenethyl
There
is
no
evidence
of
increased
susceptibility
of
young
rats
in
the
reproduction
study
with
pyraflufenethyl
EPA
concluded
there
are
no
residual
uncertainties
for
prenatal
and/
or
postnatal
exposure.
3.
Conclusion.
There
is
a
complete
toxicity
database
for
pyraflufen­
ethyl
and
exposure
data
are
complete
or
are
estimated
based
on
data
that
reasonably
accounts
for
potential
exposures.
The
field
trial
data
on
cotton,
while
some
of
which
may
be
limited
in
geographic
representation
or
lack
of
early
season
application,
indicate
that
residues
of
pyraflufen­
ethyl
are
expected
to
be
finite.
EPA
determined
that
the
10X
SF
to
protect
infants
and
children
should
be
removed
and
instead,
a
different
additional
safety
factor
of
1X
should
be
used.
The
FQPA
factor
is
removed
because:
There
is
no
evidence
of
increased
susceptibility
of
rat
or
rabbit
fetuses
following
in
utero
exposure
in
the
developmental
studies
with
pyraflufen­
ethyl;
there
is
no
evidence
of
increased
susceptibility
of
young
rats
in
the
reproduction
study
with
pyraflufenethyl
there
are
no
residual
uncertainties
identified
in
the
exposure
databases;
the
dietary
food
exposure
assessment
is
expected
to
be
conservative,
tolerancelevel
residues
and
100%
crop
treated
information
were
used;
and
dietary
drinking
water
exposure
is
based
on
conservative
modeling
estimates.

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
bwts.
Default
bwts
and
consumption
values
as
used
by
the
United
States
Environmental
Protection
Agency
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
bwts
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
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.
No
adverse
effect
attributable
to
a
single
exposure
(
dose)
of
pyraflufen­
ethyl
was
observed
in
the
oral
toxicity
studies,
including
the
developmental
toxicity
studies
in
rats
and
rabbits.
Therefore,
an
acute
RfD
was
not
established
and
no
acute
risk
is
expected.
2.
Chronic
risk.
Using
the
exposure
assumptions
described
in
this
unit
for
chronic
exposure,
EPA
has
concluded
that
exposure
to
pyraflufen­
ethyl
from
food
will
utilize
<
1%
of
the
cPAD
for
the
U.
S.
population
and
<
1%
of
the
cPAD
for
children
(
1
 
6
years).
Based
on
the
use
pattern,
chronic
residential
exposure
to
residues
of
pyraflufen­
ethyl
is
not
expected.
In
addition,
there
is
potential
for
chronic
dietary
exposure
to
pyraflufen­
ethyl
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
the
following
Table
3:

TABLE
3.
 
AGGREGATE
RISK
ASSESSMENT
FOR
CHRONIC
(
NON­
CANCER)
EXPOSURE
TO
PYRAFLUFEN­
ETHYL
Population
Subgroup1
cPAD
mg/
kg/
day
%
cPAD
(
Food)
Surface
Water
EEC
(
ppb)
2
Ground
Water
EEC
(
ppb)
2
Chronic
DWLOC
(
ppb)
3
U.
S
population
0.20
<
1
0.28
0.002
7,000
Males
(
20+
years
old)
0.20
<
1
0.28
0.002
7,000
Females
(
13
 
50
years
old)
0.20
<
1
0.28
0.002
6,000
Children
(
1
 
6
years
old)
0.20
<
1
0.28
0.002
2,000
Males
(
13
 
19
years
old)
0.20
<
1
0.28
0.002
7,000
1
Subgroups
with
the
highest
food­
source
dietary
exposure
were
selected
for
adult
males,
adult
females
and
children.
The
following
bwts
were
used
(
70
kg
adult
male;
60
kg
adult
females;
10
kg
child).
2
The
crop
producing
the
highest
level
was
used
(
potatoes,
0.009
lb
active
ingredient/
acre).
3
Chronic
DWLOC
(
ppb)
=
[
maximum
chronic
water
exposure
(
mg/
kg/
day)
x
bwt
(
kg)]
÷
[
water
consumption
(
L)
x
10­
3
mg/
kg]).

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/
Vol.
68,
No.
98
/
Wednesday,
May
21,
2003
/
Rules
and
Regulations
3.
Short­
term
risk.
The
short­
term
aggregate
risk
assessment
estimates
risks
likely
to
result
from
1
 
30
days
exposure
to
pyraflufen­
ethyl
residues
from
food,
drinking
water,
and
residential
pesticide
uses.
High­
end
estimates
of
residential
exposure
are
used
in
the
short­
term
aggregate
assessment,
while
average
(
chronic)
values
are
used
to
account
for
dietary
(
food
only)
exposure.
The
shortterm
aggregate
risk
assessment
is
considered
conservative
because
foodsource
dietary
exposure
is
based
on
a
Tier
1
DEEM
assessment
(
tolerance
level
residues
and
100%
crop
treated
information
were
used).
A
short­
term
aggregate
risk
assessment
is
not
performed
for
adults
because
no
handler
exposure
is
expected
and
postapplication
inhalation
exposure
is
expected
to
be
negligible.
A
short­
term
aggregate
risk
assessment
is
required
for
infants
and
children
because
there
is
a
potential
for
oral
postapplication
exposure
resulting
from
residential
uses.
Pyraflufen­
ethyl
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
pyraflufen­
ethyl.
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
170,000
for
children
(
1
 
6
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
pyraflufen­
ethyl
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:

TABLE
4.
 
AGGREGATE
RISK
ASSESSMENT
FOR
SHORT­
TERM
EXPOSURE
TO
PYRAFLUFEN­
ETHYL
Population
Subgroup
Aggregate
MOE
(
Food
+
Residential)
1
Aggregate
Level
of
Concern
(
LOC)
Surface
Water
EEC
(
ppb)
2
Ground
Water
EEC
(
ppb)
2
Short­
Term
DWLOC
(
ppb)
3
Children
(
1
 
6
years
old)
170,000
100
0.28
0.002
2,000
1
Aggregate
MOE
=
NOAEL
(
Avg
Food
Exposure
+
Residential
Exposure).
2
The
crop
producing
the
highest
level
was
used
(
potatoes,
0.009
lb
ai/
acre).
3DWLOC(
ppb)
=
[
maximum
water
exposure
(
mg/
kg/
day)
x
bwt
(
kg)]
÷
[
water
consumption
(
L)
x
10­
3
mg/
kg]
*(
bwt:
Children­
10
kg).

4.
Intermediate­
term
risk.
The
intermediate­
term
aggregate
risk
assessment
estimates
risks
likely
to
result
from
1
 
6
months
of
exposure
to
pyraflufen­
ethyl
residues
from
food,
drinking
water,
and
residential
pesticide
uses.
High­
end
estimates
of
residential
exposure
are
used
in
the
intermediateterm
assessment,
while
average
values
are
used
for
food
and
drinking
water
exposure.
An
intermediate­
term
aggregate
risk
assessment
is
not
preformed
for
adults
because
no
handler
exposure
is
expected
and
postapplication
inhalation
exposure
is
expected
to
be
negligible.
Also,
an
intermediate­
term
aggregate
risk
assessment
is
not
preformed
for
infants
and
children
because
postapplication
exposure
over
the
intermediate­
term
duration
is
not
likely
based
on
the
use
pattern.
5.
Aggregate
cancer
risk
for
U.
S.
population.
Pyraflufen­
ethyl
has
been
classified
as
a
``
Likely
to
be
Carcinogenic
to
Humans''
by
the
oral
route
of
exposure
(
Q1*
of
3.32
x
10­
2
(
mg/
kg/
day)­
1).
Using
the
exposure
assumptions
discussed
in
this
unit
for
cancer,
the
cancinogenic
risk
is
determined
for
the
U.
S.
population
(
total)
only.
The
aggregate
cancer
DWLOC
(
2.3
ppb)
is
greater
than
EPA's
estimates
of
pyraflufen­
ethyl
residues
in
drinking
water.
Therefore,
the
aggregate
cancer
risk
from
residues
of
pyraflufenethyl
in
food
and
drinking
water
does
not
exceed
EPA's
level
of
concern
as
shown
in
the
following
Table
5:

TABLE
5.
 
CANCER
DWLOC
CALCULATIONS
FOR
THE
U.
S.
POPULATION
Q1*
mg/
kg/
day)­
1
Negligible
Risk
Level1
Aggregate
cancer
risk
(
food
and
residential
Ground
Water
EEC2
(
ppb)
Surface
Water
EEC2
(
ppb)
Cancer
DWLOC3
(
ppb)

0.0332
3.0E­
6
8.3E­
7
0.002
0.28
2.3
1
Negligible
risk
is
that
below
10­
6.
3.0E­
6
is
statistically
within
the
range
that
EPA
generally
accepts
as
``
negligible
risk''.
2
The
crop
producing
the
highest
level
was
used
(
potatoes).
3Cancer
DWLOC
(
ppb)
=
[
maximum
water
exposure
(
mg/
kg/
day)
x
bwt
(
kg)]
÷
[
water
consumption
(
L)
x
10­
3
mg/
kg]

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
pyraflufenethyl
residues.
IV.
Other
Considerations
A.
Analytical
Enforcement
Methodology
Nichino
America,
Inc.
has
submitted
a
petition
method
validation
(
PMV)
and
an
independent
laboratory
validation
for
a
Gas
Chromatography/
Mass
Spectometry
(
GC/
MS)
method
proposed
for
the
enforcement
of
tolerances
for
residues
of
pyraflufen
ethyl
and
its
acid
metabolite,
E­
1.
The
proposed
plant
method
is
adequate
for
enforcement
of
tolerances
in/
on
cotton.
Adequate
enforcement
methodology
(
example
 
GC)
is
available
to
enforce
the
tolerance
expression.
The
method
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.

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Vol.
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No.
98
/
Wednesday,
May
21,
2003
/
Rules
and
Regulations
B.
International
Residue
Limits
There
is
neither
a
Codex
proposal,
nor
Canadian
or
Mexican
limits,
for
residues
of
pyraflufen­
ethyl
in/
on
cotton.
Harmonization
is
not
an
issue
for
this
petition.

C.
Conditions
A
risk
assessment
for
human
health
has
been
conducted
for
this
proposed
use.
Using
the
proposed
or
recommended
tolerances,
the
chronic
estimates
are
well
below
the
Agency's
level
of
concern
and
the
cancer
risk
estimate
is
also
within
Agency's
level
of
concern.
The
following
data
are
being
required
by
the
Agency
to
complete
the
database
requirements
prior
to
approval
of
an
unconditional
registration
of
pyraflufen­
ethyl
on
cotton:
 
Product
label
contain
a
statement
limiting
use
to
commercial
applicators
only
so
that
possible
use
by
homeowners
on
residential
turf
would
be
minimized
and/
or
include
a
restriction
prohibiting
use
by
homeowners
for
the
turf
and
ornamental
use
sites.
 
Proposed
uses
in
farmyards,
farm
buildings,
fence
lines,
dry
ditches
and
ditch
banks
be
removed
from
the
label
due
to
the
potential
for
residues
to
contact
food
sources
in
these
use
sites.
 
The
label
for
pyraflufen
ethyl
should
clearly
state
the
allowable
number
of
applications
per
season.

V.
Conclusion
Therefore,
tolerances
are
established
for
combined
residues
of
pyraflufenethyl
(
ethyl
2­
chloro­
5­(
4­
chloro­
5­
difluoromethoxy­
1­
methyl­
1H­
pyrazol­
3­
yl)­
4­
fluorophenoxyacetate)
and
its
acid
metabolite,
E­
1
(
2­
chloro­
5­(
4­
chloro­
5­
difluoromethoxy­
1­
methyl­
1Hpyrazol
3­
yl)­
4­
fluorophenoxyacetic
acid),
expressed
pyraflufen­
ethyl
in
or
on
cotton
undelinted
seed
at
0.04
ppm
and
cotton
gin
byproduct
at
1.5
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
 
0163
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
July
21,
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
 
0163,
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
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21,
2003
/
Rules
and
Regulations
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
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:
May
7,
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
180.585
is
amended
by
alphabetically
adding
commodities
in
the
table
in
paragraph
(
a)
to
read
as
follows:

§
180.585
Pyraflufen­
ethyl;
tolerances
for
residues.

(
a)
*
*
*

Commodity
Parts
per
million
Cotton,
gin
byproduct
..................................................................................................................
1.5
Cotton,
undelinted
seed
...............................................................................................................
0.04
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Federal
Register
/
Vol.
68,
No.
98
/
Wednesday,
May
21,
2003
/
Rules
and
Regulations
*
*
*
*
*
[
FR
Doc.
03
 
12359
Filed
5
 
20
 
03;
8:
45
am]

BILLING
CODE
6560
 
50
 
S
ENVIRONMENTAL
PROTECTION
AGENCY
40
CFR
Part
180
[
OPP
 
2003
 
0151;
FRL
 
7305
 
2]

Indoxacarb;
Pesticide
Tolerances
for
Emergency
Exemptions
AGENCY:
Environmental
Protection
Agency
(
EPA).
ACTION:
Final
rule.

SUMMARY:
This
regulation
establishes
a
time­
limited
tolerance
for
combined
residues
of
indoxacarb
and
its
Renantimomer
in
or
on
collards.
This
action
is
in
response
to
EPA's
granting
of
an
emergency
exemption
under
section
18
of
the
Federal
Insecticide,
Fungicide,
and
Rodenticide
Act
(
FIFRA)
authorizing
use
of
the
pesticide
on
collards.
This
regulation
establishes
a
maximum
permissible
level
for
residues
of
indoxacarb
in
this
food
commodity.
The
tolerance
will
expire
and
is
revoked
on
June
30,
2006.
DATES:
This
regulation
is
effective
May
21,
2003.
Objections
and
requests
for
hearings,
identified
by
docket
ID
number
OPP
 
2003
 
0151,
must
be
received
on
or
before
July
21,
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
VII.
of
the
SUPPLEMENTARY
INFORMATION.
FOR
FURTHER
INFORMATION
CONTACT:
Barbara
Madden,
Registration
Division
(
7505C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001;
telephone
number:
(
703)
305
 
6463;
e­
mail
address:
Madden.
Barbara@
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
a
federal
or
state
government
agency
(
NAICS
9241)
involved
in
administration
of
environmental
quality
programs
(
i.
e.,
Departments
of
Agriculture,
Environment,
etc).
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
 
0151.
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.
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
EPA,
on
its
own
initiative,
in
accordance
with
sections
408(
e)
and
408(
l)(
6)
of
the
Federal
Food,
Drug,
and
Cosmetic
Act
(
FFDCA),
21
U.
S.
C.
346a,
is
establishing
a
tolerance
for
combined
residues
of
the
insecticide
indoxacarb
[(
S)­
methyl
7­
chloro­
2,5­
dihydro­
2­
[[(
methoxycarbonyl)[
4­
(
trifluoromethoxy)
phenyl]
amino]
carbonyl]
indeno
[
1,2­
e][
1,3,4]
oxadiazine­
4a(
3H)­
carboxylate]
and
its
R­
enantimomer
[(
R)­
methyl
7­
chloro­
2,5­
dihydro­
2­
[[(
methoxycarbonyl)[
4­
(
trifluoromethoxy)
phenyl]
amino]
carbonyl]
indeno
[
1,2­
e][
1,3,4]
oxadiazine­
4a(
3H)­
carboxylate
in
or
on
collards
at
3.0
parts
per
million
(
ppm).
This
tolerance
will
expire
and
is
revoked
on
June
30,
2006.
EPA
will
publish
a
document
in
the
Federal
Register
to
remove
the
revoked
tolerance
from
the
Code
of
Federal
Regulations.
Section
408(
l)(
6)
of
the
FFDCA
requires
EPA
to
establish
a
time­
limited
tolerance
or
exemption
from
the
requirement
for
a
tolerance
for
pesticide
chemical
residues
in
food
that
will
result
from
the
use
of
a
pesticide
under
an
emergency
exemption
granted
by
EPA
under
section
18
of
FIFRA.
Such
tolerances
can
be
established
without
providing
notice
or
period
for
public
comment.
EPA
does
not
intend
for
its
actions
on
section
18­
related
tolerances
to
set
binding
precedents
for
the
application
of
section
408
of
the
FFDCA
and
the
new
safety
standard
to
other
tolerances
and
exemptions.
Section
408(
e)
of
the
FFDCA
allows
EPA
to
establish
a
tolerance
or
an
exemption
from
the
requirement
of
a
tolerance
on
its
own
initiative,
i.
e.,
without
having
received
any
petition
from
an
outside
party.
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.
.
.
.''
Section
18
of
the
FIFRA
authorizes
EPA
to
exempt
any
Federal
or
State
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