Document ID: EPA-HQ-OPP-2003-0034-0001
Agency: epa
Document Type: Rule
Title: Imazamox; Exemption from the Requirement of a Tolerance
Posted Date: 2003-02-14T05:00Z

7428
Federal
Register
/
Vol.
68,
No.
31
/
Friday,
February
14,
2003
/
Rules
and
Regulations
ADDRESSES:
Materials
referred
to
in
this
document
are
available
for
inspection
or
copying
at
the
office
of
the
Eighth
Coast
Guard
District,
Bridge
Administration
Branch,
Hale
Boggs
Federal
Building,
room
1313,
501
Magazine
Street,
New
Orleans,
Louisiana
70130
 
3396
between
7
a.
m.
and
3
p.
m.,
Monday
through
Friday,
except
Federal
holidays.
The
telephone
number
is
504
 
589
 
2965.
The
Bridge
Administration
Branch,
Eighth
District,
maintains
the
public
docket
for
this
temporary
deviation.

FOR
FURTHER
INFORMATION
CONTACT:
David
Frank,
Bridge
Administration
Branch,
telephone
(
504)
589
 
2965.

SUPPLEMENTARY
INFORMATION:
The
Louisiana
Department
of
Transportation
and
Development
has
requested
a
temporary
deviation
in
order
to
repair
the
fender
system
of
the
bridge.
The
repairs
are
necessary
for
the
continued
safe
operation
of
the
bridge.
This
deviation
allows
the
draw
of
the
SR
384
bridge
to
remain
closed
to
navigation
from
7
a.
m.
until
11
a.
m.
and
from
1
p.
m.
until
5
p.
m.
daily,
Monday
through
Thursday,
from
February
17,
2003
through
March
27,
2003.
The
pontoon
bridge
has
no
vertical
clearance
in
the
closed­
to­
navigation
position.
The
bridge
normally
opens
to
pass
navigation
an
average
of
1005
times
a
month.
In
accordance
with
33
CFR
117.5,
the
bridge
opens
on
signal
for
the
passage
of
vessels.
The
bridge
will
be
able
to
open
for
emergencies
during
the
closure
period;
however,
pile­
driving
equipment
will
have
to
be
secured
and
moved
prior
to
the
opening
of
the
bridge.
Navigation
on
the
waterway
consists
mainly
of
tugs
with
tows
and
some
fishing
vessels.
No
practical
alternate
route
is
readily
available.
In
accordance
with
33
CFR
117.35(
c),
this
work
will
be
performed
with
all
due
speed
in
order
to
return
the
bridge
to
normal
operation
as
soon
as
possible.
This
deviation
from
the
operating
regulations
is
authorized
under
33
CFR
117.35.

Dated:
February
5,
2003.

Marcus
Redford,

Bridge
Administrator.
[
FR
Doc.
03
 
3738
Filed
2
 
13
 
03;
8:
45
am]

BILLING
CODE
4910
 
15
 
P
ENVIRONMENTAL
PROTECTION
AGENCY
40
CFR
Part
52
[
LA
 
63
 
2
 
7585;
FRL
 
7451
 
8]

Approval
of
Revisions
to
the
Louisiana
Department
of
Environmental
Quality
Title
33
Environmental
Quality
Part
III;
Chapter
6
Emission
Reduction
Credits
Banking
in
Nonattainment
Areas
AGENCY:
Environmental
Protection
Agency
(
EPA).
ACTION:
Final
rule;
correction.

SUMMARY:
The
Environmental
Protection
Agency
(
EPA)
published
in
the
Federal
Register
of
September
27,
2002
(
67
FR
60871)
a
document
approving
revisions
to
the
Louisiana
Department
of
Environmental
Quality
Title
33
Environmental
Quality
Part
III;
Air
Chapter
6
Emission
Reduction
Credits
Banking
in
Nonattainment
Areas.
This
document
corrects
an
error
in
the
September
30,
2002,
rulemaking
action.
EFFECTIVE
DATE:
This
rule
will
be
effective
February
14,
2003.
FOR
FURTHER
INFORMATION
CONTACT:
Ms.
Laura
Stankosky
of
the
EPA
Region
6
Air
Permits
Section
at
(
214)
665
 
7525.
SUPPLEMENTARY
INFORMATION:
The
EPA
published
in
the
Federal
Register
of
September
27,
2002
(
67
FR
60871)
a
document
approving
revisions
to
the
Louisiana
Department
of
Environmental
Quality
Title
33
Environmental
Quality
Part
III;
Air
Chapter
6
Emission
Reduction
Credits
Banking
in
Nonattainment
Areas.
On
page
60873
of
the
September
27,
2002
action,
EPA
incorrectly
stated
that
Tulane
Environmental
Law
Clinic
(
TELC)
submitted
comments.
We
should
instead
have
stated
that
the
TELC
submitted
comments
on
behalf
of
its
client,
the
Louisiana
Environmental
Action
Network
(
LEAN).

Authority:
42
U.
S.
C.
7401
et
seq.

Dated:
January
30,
2003.
Lawrence
E.
Starfield,
Acting
Regional
Administrator,
Region
6.
[
FR
Doc.
03
 
3583
Filed
2
 
13
 
03;
8:
45
am]

BILLING
CODE
6560
 
50
 
P
ENVIRONMENTAL
PROTECTION
AGENCY
40
CFR
Part
180
[
OPP
 
2003
 
0034;
FRL
 
7291
 
3]

Imazamox;
Exemption
from
the
Requirement
of
a
Tolerance
AGENCY:
Environmental
Protection
Agency
(
EPA).
ACTION:
Final
rule.

SUMMARY:
This
regulation
establishes
an
exemption
from
the
requirement
of
a
tolerance
for
residues
of
the
imazamox
on
all
food
commodities
when
applied/
used
as
a
herbicide.
The
Interregional
Research
Project
Number
4
(
IR­
4)
submitted
a
petition
to
EPA
under
the
Federal
Food,
Drug,
and
Cosmetic
Act,
as
amended
by
the
Food
Quality
Protection
Act
of
1996,
requesting
an
exemption
from
the
requirement
of
a
tolerance.
After
review
of
the
available
data,
EPA
determined
that
the
toxicological
profile
for
imazamox
supports
an
exemption
from
the
requirement
of
a
tolerance;
no
adverse
effects
were
observed
in
the
submitted
toxicological
studies
regardless
of
the
route
of
exposure.
Since
this
regulation
eliminates
the
need
to
establish
maximum
permissible
levels
for
residues
of
imazamox,
the
Agency
is
also
deleting
40
CFR
180.508,
which
includes
previously
established
maximum
permissible
levels
for
residues
of
imazamox.
DATES:
This
regulation
is
effective
February
14,
2003.
Objections
and
requests
for
hearings,
identified
by
docket
ID
number
OPP
 
2003
 
0034,
must
be
received
on
or
before
April
15,
2003.
ADDRESSES:
Written
objections
and
hearing
requests
submitted
electronically,
by
mail,
or
through
hand
delivery/
courier.
Follow
the
detailed
instructions
as
provided
in
Unit
IX.
of
the
SUPPLEMENTARY
INFORMATION.
FOR
FURTHER
INFORMATION
CONTACT:
Hoyt
Jamerson,
Registration
Division
(
7505C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001;
telephone
number:
(
703)
308
 
9368;
e­
mail
address:
jamerson.
hoyt@
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
 
Animal
production
 
Food
manufacturing
 
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
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7429
Federal
Register
/
Vol.
68,
No.
31
/
Friday,
February
14,
2003
/
Rules
and
Regulations
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
 
0034.
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
December
23,
2002
(
67
FR
78229)
(
FRL
 
7284
 
5),
EPA
issued
a
notice
pursuant
to
section
408
of
the
Federal
Food,
Drug,
and
Cosmetic
Act
(
FFDCA),
21
U.
S.
C.
346a,
as
amended
by
the
Food
Quality
Protection
Act
(
FQPA)
(
Public
Law
104
 
170),
announcing
the
filing
of
a
pesticide
tolerance
petition
(
PP
2E6472)
by
BASF
Corporation,
26
Davis
Drive,
Research
Triangle
Park,
NC
27709.
This
notice
included
a
summary
of
the
petition
prepared
by
BASF
Corporation.
There
were
no
comments
received
in
response
to
the
notice
of
filing.
The
petition
requested
that
40
CFR
part
180
be
amended
by
establishing
an
exemption
from
the
requirement
of
a
tolerance
for
residues
of
imazamox
(
2­
[
4,5­
dihydro­
4­(
1­
methylethyl)­
5­
oxo­
1H­
imidazol­
2­
yl]­
5­
methoxymethyl­
3­
pyridinecarboxylic
acid)
in
or
on
all
food
commodities.
Section
408(
b)(
2)(
A)(
i)
of
the
FFDCA
allows
EPA
to
establish
an
exemption
from
the
requirement
for
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)
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)
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.
First,
EPA
determines
the
toxicity
of
pesticides.
Second,
EPA
examines
exposure
to
the
pesticide
through
food,
drinking
water,
and
through
other
exposures
that
occur
as
a
result
of
pesticide
use
in
residential
settings.

III.
Toxicological
Profile
Consistent
with
section
408(
b)(
2)(
D)
of
FFDCA,
EPA
has
reviewed
the
available
scientific
data
and
other
relevant
information
in
support
of
this
action
and
considered
its
validity,
completeness
and
reliability
and
the
relationship
of
this
information
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
imazamox
are
discussed
in
this
unit.

TABLE
1.
 
SUBCHRONIC,
CHRONIC,
AND
OTHER
TOXICITY
Guideline
No.
Study
Type
Results
870.3100
90­
Day
oral
toxicity
rodents
NOAEL
=
1661
milligram/
kilogram/
day
(
mg/
kg/
day),
highest
dose
tested
(
HDT)
There
were
no
treatment­
related
effects
observed
in
this
study.

870.3150
90­
Day
oral
toxicity
in
nonrodents
NOAEL
=
1.3
gram/
kilogram/
day
(
g/
kg/
day)
(
HDT)
There
were
no
treatment­
related
effects
observed
in
this
study.

870.3200
21/
28­
Day
dermal
toxicity
NOAEL
=
1000
mg/
kg/
day
(
HDT)
There
were
no
observed
toxic
effects
at
any
dose
level.

870.3700a
Prenatal
developmental
in
rodents
(
rat)
Maternal
NOAEL
=
>
1000
mg/
kg/
day
(
limit
dose)

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Vol.
68,
No.
31
/
Friday,
February
14,
2003
/
Rules
and
Regulations
TABLE
1.
 
SUBCHRONIC,
CHRONIC,
AND
OTHER
TOXICITY
 
Continued
Guideline
No.
Study
Type
Results
No
maternal
toxicity
or
clinical
signs
of
toxicity
were
observed
Mean
body
weight
gain
was
reduced
during
the
early
dosing
periods
(
days
6
 
12)
at
the
1000
mg/
kg/
day
dose
compared
to
the
control
group.
Body
weights
were
comparable
between
the
treated
and
the
control
groups
for
the
remainder
of
the
dosage
period
(
days
12
 
16)
and
the
post
dosage
period
(
days
16
to
20).
Slightly
reduced
mean
body
weight
gain
observed
during
early
dosing
period
(
days
6
 
12)
was
not
considered
biologically
relevant.
Developmental
NOAEL
=
equal
to
or
greater
than
1000
mg/
kg/
day.
No
treatment­
related
fetal
gross
external,
visceral
or
skeletal
malformations
or
variations
were
seen
at
any
dose
level.

870.3700b
Prenatal
developmental
in
nonrodents
(
rabbit)
Maternal
NOAEL
=
900
mg/
kg/
day
(
HDT)
Marginally
reduced
body
weights
and
slightly
decreased
food
consumption
in
F1
males
and
females
were
observed
in
in
test
animals
at
the
900
mg/
kg/
day
dose
level,
but
were
not
considered
biologically
significant.
Developmental
NOAEL
=
equal
to
or
greater
than
900
mg/
kg/
day
(
HDT)
There
were
no
treatment­
related
developmental
effects
observed
at
any
of
the
administered
dose
levels.

870.3800
Reproduction
and
fertility
effects
Parental/
Systemic
NOAEL
=
1469
mg/
kg/
day
in
males/
1705
mg/
kg/
day
in
females
(
HDT)
There
were
no
treatment­
related
systemic
or
reproductive
toxicity
observed
at
any
of
the
administered
dose
levels.

870.4100b
Chronic
toxicity
dogs
NOAEL
=
1,165
mg/
kg/
day
(
HDT)
There
were
no
treatment­
related
effects
observed
at
any
of
the
administered
dose
levels.

870.4200
Carcino­
genicity
rats
NOAEL
=
1,068
mg/
kg/
day
in
males/
1,284
mg/
kg/
day
in
females
(
HDT)
There
were
no
treatment­
related
effects
observed
in
this
study.
There
was
no
evidence
of
carcinogenicity
in
rats
treated
with
imazamox
in
the
diet
for
24
months.
The
highest
dose
tested
(
1,068/
1,284
mg/
kg/
day)
is
considered
an
adequate
upper
limit
for
this
study.

870.4300
Carcino­
genicity
mice
NOAEL
=
1,053
mg/
kg/
day
for
males
(
HDT)/
1,348
mg/
kg/
day
for
females
(
HDT)
There
were
no
treatment­
related
effects
observed
in
this
study.
There
was
no
evidence
of
carcinogenicity
in
mice
treated
with
imazamox
in
the
diet
for
24
months.
The
highest
dose
tested
(
1,053/
1,348
mg/
kg/
day)
is
considered
an
adequate
upper
limit
for
this
study.

870.5100
Gene
Mutation
Negative
870.5375
Cytogenetics
Negative
870.5385
Other
Effects
Negative
870.7485
Metabolism
and
pharmacokinetics
[
14]
CImazamox
was
readily
absorbed
by
male
and
female
rats
following
intravenous
or
oral
dosing.
Imazamox
was
rapidly
excreted
as
the
unchanged
parent
compound,
primarily
in
the
urine
following
intravenous
administration
and
in
the
urine
and
feces
following
oral
administration.

IV.
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.
Based
on
a
review
of
the
available
data,
EPA
concluded
that
imazamox
showed
no
toxicological
endpoints
of
concern
and,
therefore,
no
dietary,
occupational,
residential,
or
aggregate
risk
assessments
are
needed.

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14,
2003
/
Rules
and
Regulations
V.
Aggregate
Exposures
In
examining
aggregate
exposure,
FFDCA
section
408
directs
EPA
to
consider
available
information
concerning
exposures
from
the
pesticide
residue
in
food
and
all
other
nonoccupational
exposures,
including
drinking
water
from
ground
water
or
surface
water
and
exposure
through
pesticide
use
in
gardens,
lawns,
or
buildings
(
residential
and
other
indoor
uses).

A.
Dietary
Exposure
1.
Dietary
exposure
from
food
and
feed
uses.
Tolerances
have
been
established
(
40
CFR
180.508)
for
residues
of
imazamox,
per
se,
in
or
on
canola
and
the
legume
vegetable
group;
imazamox
and
its
metabolite
AC263284
in
or
on
wheat
(
bran,
germ,
grain,
forage,
hay,
shorts,
and
straw);
and
imazamox
and
its
metabolites
AC26284
and
AC312622
in
or
on
alfalfa
(
seed,
forage
and
hay).
Time­
limited
tolerances
for
section
18
emergency
exemptions
are
established
for
dry
bean
and
canola.
Section
180.508,
which
lists
the
maximum
permissible
levels
for
imazamox,
will
be
removed
since
this
regulation
eliminates
the
need
to
establish
maximum
permissible
levels
for
residues
of
the
pesticide.
i.
Acute
exposure.
Acute
dietary
risk
assessments
are
performed
for
a
fooduse
pesticide
if
a
toxicological
study
has
indicated
the
possibility
of
an
effect
of
concern
occurring
as
a
result
of
a
one
day
or
single
exposure.
EPA
concluded
that
no
acute
toxicological
endpoint
was
identified
from
the
toxicological
studies
submitted
for
imazamox,
including
oral
developmental
toxicity
studies
in
rats
and
rabbits.
Therefore,
an
acute
dietary
risk
assessment
was
not
conducted.
ii.
Chronic
exposure.
EPA
concluded
that
a
chronic
dietary
risk
assessment
is
not
needed
since
no
toxicity
was
observed
at
doses
exceeding
the
Limit­
Dose
(
1,000
mg/
kg/
day
and
higher)
in
chronic
and
subchronic
studies
in
mice,
rats,
and
dogs.
A
dose
of
1,000
mg/
kg/
day
is
equivalent
to
a
human
diet
in
which
the
pesticide
comprises
approximately
7
percent
of
dietary
consumption.
iii.
Cancer.
Imazamox
is
classified
as
a
``
not
likely
human
carcinogen''
based
on
the
lack
of
evidence
of
carcinogenicity
in
mice
and
rats.
Therefore
a
cancer
risk
assessment
was
not
performed.
2.
Drinking
water
exposure.
The
Agency
lacks
sufficient
monitoring
exposure
data
to
complete
a
comprehensive
dietary
exposure
analysis
and
risk
assessment
for
imazamox
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
imazamox.
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
SCI­
GROW
model
is
used
to
predict
pesticide
concentrations
in
shallow
groundwater.
For
a
screening­
level
assessment
for
surface
water
EPA
will
use
FIRST
(
a
tier
1
model)
before
using
PRZM/
EXAMS
(
a
tier
2
model).
The
FIRST
model
is
a
subset
of
the
PRZM/
EXAMS
model
that
uses
a
specific
highend
runoff
scenario
for
pesticides.
While
both
FIRST
and
PRZM/
EXAMS
incorporate
an
index
reservoir
environment,
the
PRZM/
EXAMS
model
includes
a
percent
crop
area
factor
as
an
adjustment
to
account
for
the
maximum
percent
crop
coverage
within
a
watershed
or
drainage
basin.
None
of
these
models
include
consideration
of
the
impact
processing
(
mixing,
dilution,
or
treatment)
of
raw
water
for
distribution
as
drinking
water
would
likely
have
on
the
removal
of
pesticides
from
the
source
water.
The
primary
use
of
these
models
by
the
Agency
at
this
stage
is
to
provide
a
coarse
screen
for
sorting
out
pesticides
for
which
it
is
highly
unlikely
that
drinking
water
concentrations
would
ever
exceed
human
health
levels
of
concern.
Based
on
the
FIRST
and
SCI­
GROW
models
the
estimated
environmental
concentrations
(
EECs)
for
imazamox
for
acute
exposures
are
estimated
to
be
5.7
parts
per
billion
(
ppb)
for
surface
water
and
1.0
ppb
for
ground
water.
The
EECs
for
chronic
exposures
are
estimated
to
be
0.61
ppb
for
surface
water
and
1.0
ppb
for
ground
water.

B.
Other
Non­
Occupational
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).
Imazamox
is
not
registered
or
proposed
for
use
on
any
sites
that
would
result
in
residential
exposure.

VI.
Cumulative
Effects
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
imazamox
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,
imazamox
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
imazamox
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
Bifenthrin
Pesticide
Tolerances
(
62
FR
62961,
November
26,
1997)
(
FRL
 
5754
 
7).

VII.
Determination
of
Safety
for
U.
S.
Population,
Infants
and
Children
1.
U.
S.
Population.
The
toxicological
profile
for
imazamox
supports
a
tolerance
exemption
since
no
adverse
effects
were
observed
in
the
submitted
toxicological
studies
regardless
of
the
route
of
exposure.
EPA
does
not
expect
imazamox
to
pose
a
dietary
risk
under
reasonable
foreseeable
circumstances
and,
thus,
EPA
concludes
that
there
is
a
reasonable
certainty
of
no
harm
from
aggregate
exposure
to
imazamox
residues.
Accordingly,
EPA
finds
that
exempting
imazamox
from
the
requirement
of
a
tolerance
will
be
safe.
2.
Infants
and
children.
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.
EPA
concludes
there
is
a
complete
toxicity
data
base
for
imazamox
and
there
is
no
evidence
of
pre­
natal
or
postnatal
toxicity
to
rat
or
rabbit
fetuses
following
in
utero
exposure
in
the
developmental
studies
or
to
young
rats
in
the
reproduction
study.
Due
to
the
lack
of
toxicity
in
the
animal
studies,

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Vol.
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No.
31
/
Friday,
February
14,
2003
/
Rules
and
Regulations
EPA
did
not
use
a
margin
of
exposure
(
safety)
approach
to
assess
the
safety
of
imazamox.
For
this
same
reason,
an
additional
margin
of
safety
is
not
needed
for
infants
and
children.
The
Agency
concludes
that
an
exemption
from
the
requirement
of
a
tolerance
for
imazamox
will
be
safe
for
infants
and
children.

VIII.
Other
Considerations
A.
Analytical
Method(
s)

An
analytical
method
for
enforcement
purposes
is
not
required,
this
action
eliminates
the
need
for
maximum
permissible
levels
for
residues
of
imazamox
in
or
on
food
commodities.

B.
Existing
Tolerances
Tolerances
are
established
(
40
CFR
180.508)
for
residues
of
imazamox,
per
se,
in
or
on
canola
and
the
legume
vegetable
group;
imazamox
and
its
metabolite
AC263284
in
or
on
wheat
(
bran,
germ,
grain,
forage,
hay,
shorts,
and
straw);
and
imazamox
and
its
metabolites
AC26284
and
AC312622
in
or
on
alfalfa
(
seed,
forage
and
hay).
Time­
limited
tolerances
for
section
18
emergency
exemptions
are
established
for
dry
bean
and
canola.
Section
180.508
will
be
removed
since
this
regulation
eliminates
the
need
for
maximum
permissible
levels
for
residues
of
the
pesticide.

C.
International
Tolerances
There
are
no
established
or
proposed
Codex
Maximum
Residue
Limits
(
MRLs)
for
imazamox.

IX.
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
of
1996,
EPA
will
continue
to
use
those
procedures,
with
appropriate
adjustments,
until
the
necessary
modifications
can
be
made.
The
new
section
408(
g)
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),
as
was
provided
in
the
old
FFDCA
sections
408
and
409.
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
 
0034
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
April
15,
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
IX.
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
 
0034,
to:
Public
Information
and
Records
Integrity
Branch,
Information
Resources
and
Services
Division
(
7502C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001.
In
person
or
by
courier,
bring
a
copy
to
the
location
of
the
PIRIB
described
in
Unit
I.
B.
1.
You
may
also
send
an
electronic
copy
of
your
request
via
e­
mail
to:
oppdocket
epa.
gov.
Please
use
an
ASCII
file
format
and
avoid
the
use
of
special
characters
and
any
form
of
encryption.
Copies
of
electronic
objections
and
hearing
requests
will
also
be
accepted
on
disks
in
WordPerfect
6.1/
8.0
or
ASCII
file
format.
Do
not
include
any
CBI
in
your
electronic
copy.
You
may
also
submit
an
electronic
copy
of
your
request
at
many
Federal
Depository
Libraries.

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

X.
Statutory
and
Executive
Order
Reviews
This
final
rule
establishes
an
exemption
from
the
tolerance
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Register
/
Vol.
68,
No.
31
/
Friday,
February
14,
2003
/
Rules
and
Regulations
requirement
under
FFDCA
section
408(
d)
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
FFDCA
section
408(
d),
such
as
the
exemption
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
FFDCA
section
408(
n)(
4).
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.

XI.
Submission
to
Congress
and
the
Comptroller
General
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:
February
4,
2003.
Debra
Edwards,
Acting
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.

§
180.508
[
Removed]

2.
Section
180.508
is
removed.
3.
Section
180.1223
is
added
to
subpart
D
to
read
as
follows:

§
180.1223
Imazamox;
exemption
from
the
requirement
of
a
tolerance.

The
herbicide
imazamox,
(
±
)
2,
­[
4,5­
dihydro­
4­
methyl­
4­(
1­
methylethyl)­
5­
oxo­
1H­
imidazol­
2­
yl]­
5­
(
methoxymethyl)­
3­
pyridinecarboxylic
acid,
is
exempt
from
the
requirement
of
a
tolerance
on
all
food
commodities
when
applied
as
a
herbicide
in
accordance
with
good
agricultural
practices.

[
FR
Doc.
03
 
3699
Filed
2
 
13
 
03;
8:
45
am]

BILLING
CODE
6560
 
50
 
S
LEGAL
SERVICES
CORPORATION
45
CFR
Part
1602
Procedures
for
Disclosure
of
Information
Under
the
Freedom
of
Information
Act
AGENCY:
Legal
Services
Corporation.
ACTION:
Final
rule.

SUMMARY:
This
Final
Rule
makes
several
revisions
to
the
LSC
regulations
implementing
the
Freedom
of
Information
Act.
The
revisions
add
provisions
detailing
the
submitter's
rights
process,
provide
LSC
with
express
authority
to
defer
action
on
pending
and
additional
requests
and
appeals
when
a
requester
has
an
outstanding
fee
balance,
and
clarify
the
applicable
fee
waiver
standards.
LSC
is
also
revising
the
applicable
fee
structure
to
better
reflect
LSC's
costs
in
complying
with
FOIA.
Finally,
the
Final
Rule
contains
technical
changes
to
reflect
current
LSC
nomenclature.

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