Document ID: EPA-HQ-OPP-2002-0342-0001
Agency: epa
Document Type: Notice
Title: Imazamox; Notice of Filing a Pesticide Petition to Establish a Tolerance for a Certain Pesticide 
Chemical in or on Food
Posted Date: 2002-12-23T05:00Z

78229
Federal
Register
/
Vol.
67,
No.
246
/
Monday,
December
23,
2002
/
Notices
SIP,
the
order
requires
EPA
Region
8
to
review
the
SIP
itself
to
determine
whether
emissions
exception
provisions
are
contrary
to
EPA
policy.
Finally,
the
Administrator's
order
denies
the
petition's
claim
that
``
new
information''
about
smoke
filling
the
town
of
Buffalo,
Wyoming,
and
the
source's
compliance
history
show
a
need
for
continuous
monitoring.
The
petitioner's
request
is
denied
because
the
issue
of
monitoring
has
been
adequately
addressed
above,
and
petitioners
failed
to
demonstrate
that
any
applicable
requirement
is
missing
from
the
permit
or
that
the
permit
otherwise
fails
to
comply
with
the
requirements
of
the
regulation.
Additional
explanation
for
the
Administrator's
decision
can
be
found
in
the
order.

Patricia
D.
Hull,

Acting
Regional
Administrator,
Region
8.
[
FR
Doc.
02
 
32261
Filed
12
 
20
 
02;
8:
45
am]

BILLING
CODE
6560
 
50
 
P
ENVIRONMENTAL
PROTECTION
AGENCY
[
OPP
 
2002
 
0342;
FRL
 
7284
 
5]

Imazamox;
Notice
of
Filing
a
Pesticide
Petition
to
Establish
a
Tolerance
for
a
Certain
Pesticide
Chemical
in
or
on
Food
AGENCY:
Environmental
Protection
Agency
(
EPA).

ACTION:
Notice.

SUMMARY:
This
notice
announces
the
initial
filing
of
a
pesticide
petition
proposing
the
establishment
of
regulations
for
residues
of
a
certain
pesticide
chemical
in
or
on
various
food
commodities.

DATES:
Comments,
identified
by
docket
ID
number
OPP
 
2002
 
0342,
must
be
received
on
or
before
January
22,
2003.

ADDRESSES:
Comments
may
be
submitted
electronically,
by
mail,
or
through
hand
delivery/
courier.
Follow
the
detailed
instructions
as
provided
in
Unit
I.
of
the
SUPPLEMENTARY
INFORMATION.

FOR
FURTHER
INFORMATION
CONTACT:
Shaja
R.
Brothers,
Registration
Division
(
7505C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001;
telephone
number:
(
703)
308
 
3194;
e­
mail
address:
brothers.
shaja@
epa.
gov.
SUPPLEMENTARY
INFORMATION:

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

You
may
be
affected
by
this
action
if
you
are
an
agricultural
producer,
food
manufacturer,
or
pesticide
manufacturer.
Potentially
affected
categories
and
entities
may
include,
but
are
not
limited
to:
 
Crop
production
(
NAICS
code
111)
 
Animal
production
(
NAICS
code
112)
 
Food
manufacturing
(
NAICS
code
311)
 
Pesticide
manufacturing
(
NAICS
code
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
the
table
could
also
be
affected.
The
North
American
Industrial
Classification
System
(
NAICS)
codes
have
been
provided
to
assist
you
and
others
in
determining
whether
or
not
this
action
might
apply
to
certain
entities.
If
you
have
questions
regarding
the
applicability
of
this
action
to
a
particular
entity,
consult
the
person
listed
under
FOR
FURTHER
INFORMATION
CONTACT.

B.
How
Can
I
Get
Copies
of
this
Document
and
Other
Related
Information?

1.
Docket.
EPA
has
established
an
official
public
docket
for
this
action
under
docket
identification
(
ID)
number
OPP
 
2002
 
0342.
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/.
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.
Certain
types
of
information
will
not
be
placed
in
the
EPA
Dockets.
Information
claimed
as
CBI
and
other
information
whose
disclosure
is
restricted
by
statute,
which
is
not
included
in
the
official
public
docket,
will
not
be
available
for
public
viewing
in
EPA's
electronic
public
docket.
EPA's
policy
is
that
copyrighted
material
will
not
be
placed
in
EPA's
electronic
public
docket
but
will
be
available
only
in
printed,
paper
form
in
the
official
public
docket.
To
the
extent
feasible,
publicly
available
docket
materials
will
be
made
available
in
EPA's
electronic
public
docket.
When
a
document
is
selected
from
the
index
list
in
EPA
Dockets,
the
system
will
identify
whether
the
document
is
available
for
viewing
in
EPA's
electronic
public
docket.
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.
EPA
intends
to
work
towards
roviding
electronic
access
to
all
of
the
publicly
available
docket
materials
through
EPA's
electronic
public
docket.
For
public
commenters,
it
is
important
to
note
that
EPA's
policy
is
that
public
comments,
whether
submitted
electronically
or
in
paper,
will
be
made
available
for
public
viewing
in
EPA's
electronic
public
docket
as
EPA
receives
them
and
without
change,
unless
the
comment
contains
copyrighted
material,
CBI,
or
other
information
whose
disclosure
is
restricted
by
statute.
When
EPA
identifies
a
comment
containing
copyrighted
material,
EPA
will
provide
a
reference
to
that
material
in
the
version
of
the
comment
that
is
placed
in
EPA's
electronic
public
docket.
The
entire
printed
comment,
including
the
copyrighted
material,
will
be
available
in
the
public
docket.
Public
comments
submitted
on
computer
disks
that
are
mailed
or
delivered
to
the
docket
will
be
transferred
to
EPA's
electronic
public
docket.
Public
comments
that
are
mailed
or
delivered
to
the
docket
will
be
scanned
and
placed
in
EPA's
electronic
public
docket.
Where
practical,
physical
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/
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67,
No.
246
/
Monday,
December
23,
2002
/
Notices
objects
will
be
photographed,
and
the
photograph
will
be
placed
in
EPA's
electronic
public
docket
along
with
a
brief
description
written
by
the
docket
staff.

C.
How
and
To
Whom
Do
I
Submit
Comments?

You
may
submit
comments
electronically,
by
mail,
or
through
hand
delivery/
courier.
To
ensure
proper
receipt
by
EPA,
identify
the
appropriate
docket
ID
number
in
the
subject
line
on
the
first
page
of
your
comment.
Please
ensure
that
your
comments
are
submitted
within
the
specified
comment
period.
Comments
received
after
the
close
of
the
comment
period
will
be
marked
``
late.''
EPA
is
not
required
to
consider
these
late
comments.
If
you
wish
to
submit
CBI
or
information
that
is
otherwise
protected
by
statute,
please
follow
the
instructions
in
Unit
I.
D.
Do
not
use
EPA
Dockets
or
e­
mail
to
submit
CBI
or
information
protected
by
statute.
1.
Electronically.
If
you
submit
an
electronic
comment
as
prescribed
in
this
unit,
EPA
recommends
that
you
include
your
name,
mailing
address,
and
an
email
address
or
other
contact
information
in
the
body
of
your
comment.
Also
include
this
contact
information
on
the
outside
of
any
disk
or
CD
ROM
you
submit,
and
in
any
cover
letter
accompanying
the
disk
or
CD
ROM.
This
ensures
that
you
can
be
identified
as
the
submitter
of
the
comment
and
allows
EPA
to
contact
you
in
case
EPA
cannot
read
your
comment
due
to
technical
difficulties
or
needs
further
information
on
the
substance
of
your
comment.
EPA's
policy
is
that
EPA
will
not
edit
your
comment,
and
any
identifying
or
contact
information
provided
in
the
body
of
a
comment
will
be
included
as
part
of
the
comment
that
is
placed
in
the
official
public
docket,
and
made
available
in
EPA's
electronic
public
docket.
If
EPA
cannot
read
your
comment
due
to
technical
difficulties
and
cannot
contact
you
for
clarification,
EPA
may
not
be
able
to
consider
your
comment.
i.
EPA
Dockets.
Your
use
of
EPA's
electronic
public
docket
to
submit
comments
to
EPA
electronically
is
EPA's
preferred
method
for
receiving
comments.
Go
directly
to
EPA
Dockets
at
http://
www.
epa.
gov/
edocket,
and
follow
the
online
instructions
for
submitting
comments.
Once
in
the
system,
select
``
search,''
and
then
key
in
docket
ID
number
OPP
 
2002
 
0342
The
system
is
an
``
anonymous
access''
system,
which
means
EPA
will
not
know
your
identity,
e­
mail
address,
or
other
contact
information
unless
you
provide
it
in
the
body
of
your
comment.
ii.
E­
mail.
Comments
may
be
sent
by
e­
mail
to
opp­
docket@
epa.
gov,
Attention:
Docket
ID
Number
OPP
 
2002
 
0342.
In
contrast
to
EPA's
electronic
public
docket,
EPA's
e­
mail
system
is
not
an
``
anonymous
access''
system.
If
you
send
an
e­
mail
comment
directly
to
the
docket
without
going
through
EPA's
electronic
public
docket,
EPA's
e­
mail
system
automatically
captures
your
e­
mail
address.
E­
mail
addresses
that
are
automatically
captured
by
EPA's
e­
mail
system
are
included
as
part
of
the
comment
that
is
placed
in
the
official
public
docket,
and
made
available
in
EPA's
electronic
public
docket.
iii.
Disk
or
CD
ROM.
You
may
submit
comments
on
a
disk
or
CD
ROM
that
you
mail
to
the
mailing
address
identified
in
Unit
I.
C.
2.
These
electronic
submissions
will
be
accepted
in
WordPerfect
or
ASCII
file
format.
Avoid
the
use
of
special
characters
and
any
form
of
encryption.
2.
By
mail.
Send
your
comments
to:
Public
Information
and
Records
Integrity
Branch
(
PIRIB)
(
7502C),
Office
of
Pesticide
Programs
(
OPP),
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001,
Attention:
Docket
ID
Number
OPP
 
2002
 
0342.
3.
By
hand
delivery
or
courier.
Deliver
your
comments
to:
Public
Information
and
Records
Integrity
Branch
(
PIRIB),
Office
of
Pesticide
Programs
(
OPP),
Environmental
Protection
Agency,
Rm.
119,
Crystal
Mall
#
2,
1921
Jefferson
Davis
Hwy.,
Arlington,
VA,
Attention:
Docket
ID
Number
OPP
 
2002
 
0342.
Such
deliveries
are
only
accepted
during
the
docket's
normal
hours
of
operation
as
identified
in
Unit
I.
B.
1.

D.
How
Should
I
Submit
CBI
To
the
Agency?
Do
not
submit
information
that
you
consider
to
be
CBI
electronically
through
EPA's
electronic
public
docket
or
by
e­
mail.
You
may
claim
information
that
you
submit
to
EPA
as
CBI
by
marking
any
part
or
all
of
that
information
as
CBI
(
if
you
submit
CBI
on
disk
or
CD
ROM,
mark
the
outside
of
the
disk
or
CD
ROM
as
CBI
and
then
identify
electronically
within
the
disk
or
CD
ROM
the
specific
information
that
is
CBI).
Information
so
marked
will
not
be
disclosed
except
in
accordance
with
procedures
set
forth
in
40
CFR
part
2.
In
addition
to
one
complete
version
of
the
comment
that
includes
any
information
claimed
as
CBI,
a
copy
of
the
comment
that
does
not
contain
the
information
claimed
as
CBI
must
be
submitted
for
inclusion
in
the
public
docket
and
EPA's
electronic
public
docket.
If
you
submit
the
copy
that
does
not
contain
CBI
on
disk
or
CD
ROM,
mark
the
outside
of
the
disk
or
CD
ROM
clearly
that
it
does
not
contain
CBI.
Information
not
marked
as
CBI
will
be
included
in
the
public
docket
and
EPA's
electronic
public
docket
without
prior
notice.
If
you
have
any
questions
about
CBI
or
the
procedures
for
claiming
CBI,
please
consult
the
person
listed
under
FOR
FURTHER
INFORMATION
CONTACT.

E.
What
Should
I
Consider
as
I
Prepare
My
Comments
for
EPA?

You
may
find
the
following
suggestions
helpful
for
preparing
your
comments:
1.
Explain
your
views
as
clearly
as
possible.
2.
Describe
any
assumptions
that
you
used.
3.
Provide
copies
of
any
technical
information
and/
or
data
you
used
that
support
your
views.
4.
If
you
estimate
potential
burden
or
costs,
explain
how
you
arrived
at
the
estimate
that
you
provide.
5.
Provide
specific
examples
to
illustrate
your
concerns.
6.
Make
sure
to
submit
your
comments
by
the
deadline
in
this
notice.
7.
To
ensure
proper
receipt
by
EPA,
be
sure
to
identify
the
docket
ID
number
assigned
to
this
action
in
the
subject
line
on
the
first
page
of
your
response.
You
may
also
provide
the
name,
date,
and
Federal
Register
citation.

II.
What
Action
is
the
Agency
Taking?

EPA
has
received
a
pesticide
petition
as
follows
proposing
the
establishment
and/
or
amendment
of
regulations
for
residues
of
a
certain
pesticide
chemical
in
or
on
various
food
commodities
under
section
408
of
the
Federal
Food,
Drug,
and
Cosmetic
Act
(
FFDCA),
21
U.
S.
C.
346a.
EPA
has
determined
that
this
petition
contains
data
or
information
regarding
the
elements
set
forth
in
FFDCA
section
408(
d)(
2);
however,
EPA
has
not
fully
evaluated
the
sufficiency
of
the
submitted
data
at
this
time
or
whether
the
data
support
granting
of
the
petition.
Additional
data
may
be
needed
before
EPA
rules
on
the
petition.

List
of
Subjects
Environmental
protection,
Agricultural
commodities,
Feed
additives,
Food
additives,
Pesticides
and
pests,
Reporting
and
recordkeeping
requirements.

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Federal
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/
Vol.
67,
No.
246
/
Monday,
December
23,
2002
/
Notices
Dated:
December
12,
2002.
Peter
Caulkins,
Acting
Director,
Registration
Division,
Office
of
Pesticide
Programs.

Summary
of
Petition
The
petitioner
summary
of
the
pesticide
petition
is
printed
below
as
required
by
FFDCA
section
408(
d)(
3).
The
summary
of
the
petition
was
prepared
by
the
petitioner
and
represents
the
view
of
the
petitioner.
The
petition
summary
announces
the
availability
of
a
description
of
the
analytical
methods
available
to
EPA
for
the
detection
and
measurement
of
the
pesticide
chemical
residues
or
an
explanation
of
why
no
such
method
is
needed.

Interregional
Research
Project
Number
4
and
BASF
Corporation
PP
2E6472
EPA
has
received
a
pesticide
petition
(
2E6472)
from
Interregional
Research
Project
Number
4
(
IR
 
4),
681
U.
S.
Highway
#
1
South,
North
Brunswick,
NJ
08902
 
3390
proposing,
pursuant
to
section
408(
d)
of
the
Federal
Food,
Drug,
and
Cosmetic
Act
(
FFDCA),
21
U.
S.
C.
346a(
d),
to
amend
40
CFR
part
180.
Subpart
D
by
establishing
an
exemption
from
the
requirement
of
a
tolerance
for
imazamox,( )­
2­
4,5­
dihydro­
4­
methyl­
4­(
1­
methylethyl)­
5­
oxo­
1H­
imidazol­
2­
yl­
5­
(
methoxymethyl)­
3­
pyridinecarboxylic
acid
in
or
on
all
raw
and
processed
agricultural
commodities.
EPA
has
determined
that
the
petition
contains
data
or
information
regarding
the
elements
set
forth
in
section
408(
d)(
2)
of
the
FFDCA;
however,
EPA
has
not
fully
evaluated
the
sufficiency
of
the
submitted
data
at
this
time
or
whether
the
data
support
granting
of
the
petition.
Additional
data
may
be
needed
before
EPA
rules
on
the
petition.
This
notice
includes
a
summary
of
the
petition
prepared
by
BASF
Corporation,
Research
Triangle
Park,
27709.

A.
Residue
Chemistry
1.
Plant
metabolism.
EPA
has
concluded
that
the
nature
of
the
residue
is
adequately
understood
and
the
residues
of
concern
are
the
parent
imazamox
only.
2.
Analytical
method.
Since
imazamox
and
its
metabolic
degradates
are
not
of
toxicological
concern,
analytical
methods
are
not
applicable.
3.
Magnitude
of
residues.
Since
imazamox
and
its
metabolic
degradates
are
not
of
toxicological
concern,
and
this
petition
is
a
request
for
an
exemption
from
a
tolerance,
the
magnitude
of
residues
is
not
applicable.
B.
Toxicological
Profile
1.
Acute
toxicity.
Imazamox
technical
is
considered
to
be
nontoxic
(
toxicity
category
IV)
to
the
rat
by
the
oral
route
of
exposure.
In
the
acute
oral
toxicity
study
in
rats,
the
lethal
dose
LD50
value
of
imazamox
technical
was
greater
than
5,000
milligram/
kilogram
body
weight
(
mg/
kg
bwt)
for
males
and
females.
The
results
from
the
acute
dermal
toxicity
study
in
rabbits
indicate
that
imazamox
is
slightly
toxic
(
toxicity
category
III)
to
rabbits
by
the
dermal
exposure.
The
dermal
LD50
value
of
imazamox
technical
was
greater
than
4,000
mg/
kg
bwt
for
both
male
and
female
rabbits.
Imazamox
technical
is
considered
to
be
nontoxic
(
toxicity
category
IV)
to
the
rat
by
the
respiratory
route
of
exposure.
The
4
 
hour
lethal
concentration
LC50
value
was
greater
than
6.3
milligrams/
Liter
(
mg/
L)
(
analytical)
for
both
males
and
females.
Imazamox
technical
was
shown
to
be
non­
irritating
to
slightly
irritating
to
rabbit
skin
(
toxicity
category
IV).
Based
on
the
results
of
a
dermal
sensitization
study
(
Buehler),
imazamox
technical
is
not
considered
a
sensitizer
in
guinea
pigs.
2.
Genotoxicity.
Imazamox
technical
was
tested
in
the
following
four
assays
measuring
several
different
endpoints
of
potential
genotoxicity.
Collective
results
from
these
studies
indicate
that
imazamox
does
not
pose
a
mutagenic
or
genotoxic
risk.
i.
Bacterial
mutagenicity
assay
­
negative.
ii.
In
vitro
structural
chromosomal
aberration
assay
­
negative.
iii.
In
vitro
chinese
hampster
ovary/
hypoxanthine
guanine
phophoribosyl
transferase
(
CHO/
HGPRT)
assay
­
negative.
iv.
In
vivo
micronucleus
aberration
assay
­
negative.
3.
Reproductive
and
developmental
toxicity.
The
development
toxicity
study
in
rats
conducted
with
imazamox
technical
showed
no
evidence
of
teratogenic
effects
in
fetuses
and
no
evidence
of
developmental
toxicity.
Thus,
imazamox
is
neither
a
developmental
toxicant
nor
a
teratogen
in
the
rat.
The
results
from
this
study
supported
a
no
observed
adverse
effect
level
(
NOAEL)
for
developmental
toxicity
of
1,000
mg/
kg
bwt/
day,
the
highest
dose
tested
(
HDT)
and
limit
dose.
The
NOAEL
for
maternal
toxicity
was
500
mg/
kg
bwt/
day,
based
on
reduced
mean
body
weights,
weight
gains
and
food
consumption
at
1,000
mg/
kg
bwt/
day.
Results
from
a
developmental
toxicity
study
in
rabbits
conducted
with
imazamox
technical
also
indicated
no
evidence
of
teratogenicity
or
developmental
toxicity.
Thus,
imazamox
technical
is
neither
a
developmental
toxicant
nor
a
teratogen
in
the
rabbit.
In
the
rabbit
developmental
toxicity
study,
the
NOAEL
for
maternal
toxicity
was
300
mg/
kg
bwt/
day,
based
on
decreased
food
consumption
at
600
mg/
kg
bwt/
day,
the
next
HDT.
The
NOAEL
for
developmental
toxicity
was
900
mg/
kg
bwt/
day,
the
HDT.
The
results
from
the
2
 
generation
reproduction
toxicity
study
in
rats
with
imazamox
technical
support
a
NOAEL
for
parental
and
reproductive
toxicity
of
20,000
parts
per
million
(
ppm)
(
or
approximately
1,639
mg/
kg
bwt/
day,
calculated
from
the
food
consumption
data),
the
highest
concentration
tested
(
HCT).
The
NOAEL
for
growth
and
development
of
offspring
is
also
20,000
ppm
(
or
approximately
1,639
mg/
kg
bwt/
day).
Results
from
the
reproduction
study
and
the
developmental
toxicity
studies
conducted
with
imazamox
technical
show
no
increased
sensitivity
to
developing
offspring
as
compared
to
parental
animals,
because
the
NOAELs
for
growth
and
development
of
offspring
were
equal
to
or
greater
than
the
NOAELs
for
parental
or
maternal
toxicity.
4.
Subchronic
toxicity.
No
treatmentrelated
adverse
effects
were
noted
in
subchronic
toxicity
studies
at
the
HDT.
A
short­
term
(
28
 
day)
dermal
study
in
rabbits
was
conducted
with
imazamox
technical.
No
dermal
irritation
or
systemic
toxicity
was
observed
at
dose
levels
up
to
and
including
1,000
mg/
kg
bwt/
day
HDT,
supporting
a
NOAEL
of
1,000
mg/
kg
bwt/
day.
In
a
subchronic
(
13
 
week)
dietary
toxicity
study
in
rats
with
imazamox
technical,
no
signs
of
systemic
toxicity
were
noted,
supporting
a
NOAEL
of
20,000
ppm
(
or
approximately
1,661
mg/
kg
bwt/
day,
calculated
from
food
consumption
data),
the
HCT.
In
a
subchronic
(
90
 
day)
dietary
toxicity
study
in
dogs
with
imazamox
technical,
no
signs
of
systemic
toxicity
were
noted,
supporting
a
NOAEL
of
40,000
ppm
(
or
approximately
1,368
mg/
kg
bwt/
day,
calculated
from
the
food
consumption
data),
the
HCT.
5.
Chronic
toxicity.
The
low
order
of
mammalian
toxicity
of
imazamox
technical
is
also
evident
from
the
chronic
dietary
toxicity
studies.
These
studies
showed
no
increased
mortalities
or
clinical
signs
of
toxicity
attributed
to
imazamox
treatment.
Moreover,
there
were
no
treatment­
related
effects
on
food
consumption,
body
weights,
organ
weights,
or
hematology,
clinical
chemistry,
urinalysis
or
ophthalmologic
parameters.
There
was
no
gross
or
microscopic
evidence
of
treatmentrelated
lesions
or
carcinogenicity
in
the
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Federal
Register
/
Vol.
67,
No.
246
/
Monday,
December
23,
2002
/
Notices
three
chronic
studies
conducted
in
dogs,
mice
or
rats.
A
1
 
year
dietary
study
was
conducted
with
imazamox
technical
in
dogs
at
dietary
concentrations
of
0,
1,000,
10,000,
and
40,000
ppm.
The
NOAEL
for
this
study
was
40,000
ppm
(
or
approximately
1,165
mg/
kg
bwt/
day,
based
on
food
consumption),
the
HCT.
A
chronic
feeding/
carcinogenicity
study
was
conducted
with
imazamox
technical
in
male
and
female
rats
at
dietary
concentrations
of
0,
1,000,
10,000,
and
20,000
ppm.
The
NOAEL
for
systemic
toxicity
and
carcinogenicity
was
20,000
ppm
(
or
approximately
1,167
mg/
kg
bwt/
day,
based
on
food
consumption)
the
HCT.
A
chronic
feeding/
carcinogenicity
study
was
conducted
with
imazamox
technical
in
male
and
female
mice
at
dietary
concentration
of
500,
3,500,
and
7,000
ppm.
The
NOAEL
for
systemic
toxicity
and
carcinogenicity
was
7,000
ppm
(
or
approximately
1,201
mg/
kg
bwt/
day,
based
on
food
consumption),
the
HCT.
6.
Animal
metabolism.
The
qualitative
nature
of
the
residues
of
imazamox
and
its
metabolites
CL
263284
and
CL
263284'
s
carboxylate
AC
312622
in
animals
is
adequately
understood.
Based
on
metabolism
studies
with
goats,
hens
and
rats,
there
is
no
reasonable
expectation
that
measurable
imazamoxrelated
residues
will
occur
in
meat,
milk,
poultry
or
eggs
from
the
proposed
use.
7.
Metabolite
toxicology.
No
toxicologically
significant
metabolites
were
detected
in
plant
or
animal
metabolism
studies
for
soybeans
or
the
rest
of
the
crops
in
the
legume
vegetable
crop
grouping
(
6)
or
canola.
Therefore,
no
metabolites
need
to
be
regulated
in
these
crops.
The
plant
metabolism
study
in
wheat
indicated
very
low
residues
of
concern.
A
very
small
amount
of
the
metabolite
CL
263284
was
found
in
the
wheat
grain.
The
plant
metabolism
in
alfalfa
indicated
very
low
residues
in
the
alfalfa
seed.
However,
the
parent
imazamox
underwent
metabolism
to
the
metabolite
CL
263284
(
the
same
metabolite
seen
in
wheat).
This
metabolite
was
captured
by
a
glucose
molecule
to
form
the
glucose
conjugate
CL
189215
and
the
hydroxymethyl
AC
263284
was
also
further
oxidized
to
the
carboxylate
metabolite
CL
312622.
Both
metabolites,
CL
263284
and
CL
312622
were
present
in
the
rat
metabolism
study.
No
additional
toxicologically
significant
metabolites
were
detected
in
any
plant
or
animal
studies.
8.
Endocrine
disruption.
Collective
organ
weight
data
and
histopathological
findings
from
the
2
 
generation
rat
reproductive
study,
as
well
as
from
the
sub­
chronic
and
chronic
toxicity
studies
conducted
in
two
or
more
animal
species,
demonstrate
no
apparent
estrogenic
effects
or
effects
on
the
endocrine
system.
There
is
no
information
available
that
suggests
that
imazamox
would
be
associated
with
endocrine
effects.

C.
Aggregate
Exposure
1.
Dietary
exposure
 
i.
Food.
Residues
of
imazamox
and
its
metabolic
degradates
are
not
of
toxicological
concern.
Therefore,
dietary
exposure
through
he
food
is
not
a
concern.
ii.
Drinking
water.
Residues
of
imazamox
and
its
metabolic
degradates
are
not
of
toxicological
concern.
Therefore,
dietary
exposure
through
water
is
not
a
concern.
2.
Non­
dietary
exposure.
There
is
no
available
information
quantifying
nondietary
exposure
to
imazamox.
However,
based
on
the
physical
and
chemical
characteristics
of
the
compound,
the
proposed
use
pattern
and
available
information
concerning
its
environmental
fate,
non­
dietary
exposure
is
not
expected.

D.
Cumulative
Effects
Because
of
the
low
toxicity
of
imazamox
and
its
metabolic
degradates,
there
is
no
concern
regarding
the
potential
for
cumulative
effects
of
imazamox
and
its
degradates
with
other
substances
with
a
common
mode
of
action.
Imazamox
belongs
to
the
imidazolinone
class
of
chemistry.
The
herbicidal
activity
of
the
imidazolinones
is
due
to
the
inhibition
of
acetohydroxy
acid
synthase
(
AHAS),
an
enzyme
only
found
in
plants.
AHAS
is
part
of
the
biosynthetic
pathway
leading
to
the
formation
of
branched­
chain
amino
acids.
Animals
lack
AHAS
and
this
biosynthetic
pathway.
This
lack
of
AHAS
contributes
to
the
low
toxicity
of
imazamox
in
mammals.
We
are
aware
of
no
information
to
indicate
or
suggest
that
imazamox
has
any
toxic
effects
on
mammals
that
would
be
cumulative
with
those
of
any
other
chemical.
Since
imazamox
is
relatively
non­
toxic,
cumulative
effects
of
residues
of
imazamox
and
other
chemicals
are
not
anticipated.
Therefore,
for
the
purposes
of
this
tolerance
petition,
no
assumption
has
been
made
with
regard
to
cumulative
exposure
with
other
chemicals
having
a
common
mode
of
herbicidal
action.

E.
Safety
Determination
1.
U.
S.
population.
Because
imazamox
and
its
degradates
are
not
of
toxicological
concern
and
there
is
low
exposure
to
imazamox
and
its
degradates,
this
exemption
from
the
requirement
of
a
tolerance
in
or
on
all
raw
agricultural
commodities
will
not
pose
a
dietary
risk
under
reasonably
foreseeable
circumstances.
2.
Infants
and
children.
Likewise,
because
imazamox
and
its
degradates
are
not
of
toxicological
concern
and
there
is
low
exposure
to
imazamox
and
its
degradates,
this
exemption
from
the
requirement
of
a
tolerance
in
or
on
all
raw
agricultural
commodities
will
not
pose
a
dietary
risk
under
reasonably
foreseeable
circumstances
to
the
U.
S.
population
sub­
group
of
infants
and
children.

F.
International
Tolerances
There
is
no
Codex
maximum
residue
level
established
for
residues
of
imazamox
on
any
crops.
FR
Doc.
02
 
32260
Filed
12
 
20
 
02;
8:
45
a.
m.]

BILLING
CODE
6560
 
50
 
S
FARM
CREDIT
ADMINISTRATION
Farm
Credit
Administration
Board;
Special
Meeting
AGENCY:
Farm
Credit
Administration.
SUMMARY:
Notice
is
hereby
given,
pursuant
to
the
Government
in
the
Sunshine
Act
(
5
U.
S.
C.
552b(
e)(
3)),
of
the
special
meeting
of
the
Farm
Credit
Administration
Board
(
Board).
DATE
AND
TIME:
The
special
meeting
of
the
Board
will
be
held
at
the
offices
of
the
Farm
Credit
Administration
in
McLean,
Virginia,
on
December
20,
2002,
from
9
a.
m.
until
such
time
as
the
Board
concludes
its
business.
FOR
FURTHER
INFORMATION
CONTACT:
Jeanette
C.
Brinkley,
Acting
Secretary
to
the
Farm
Credit
Administration
Board,
(
703)
883
 
4009,
TTY
(
703)
883
 
4056.
ADDRESSES:
Farm
Credit
Administration,
1501
Farm
Credit
Drive,
McLean,
Virginia
22102
 
5090.
SUPPLEMENTARY
INFORMATION:
This
meeting
of
the
Board
will
be
open
to
the
public
(
limited
space
available).
In
order
to
increase
the
accessibility
to
Board
meetings,
persons
requiring
assistance
should
make
arrangements
in
advance.
The
matters
to
be
considered
at
the
meeting
are:

Open
Session
A.
Approval
of
Minutes
 
November
7,
2002
(
Open
and
Closed)

B.
Reports
 
FCS
Building
Association's
Quarterly
Report
 
Federal
Farm
Credit
Banks
Funding
Corporation
Update
C.
New
Business
 
Regulations
 
Proposed
Rule
 
Disclosure
of
Effective
Interest
Rates
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