370
Federal
Register
/
Vol.
68,
No.
2
/
Friday,
January
3,
2003
/
Notices
5.
Provide
specific
examples
to
illustrate
your
concerns.
6.
Offer
alternative
ways
to
improve
the
registration
activity.
7.
Make
sure
to
submit
your
comments
by
the
deadline
in
this
notice.
8.
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.
Registration
Applications
EPA
received
applications
as
follows
to
register
pesticide
products
containing
active
ingredients
not
included
in
any
previously
registered
products
pursuant
to
the
provision
of
section
3(
c)(
4)
of
FIFRA.
Notice
of
receipt
of
these
applications
does
not
imply
a
decision
by
the
Agency
on
the
applications.

Products
Containing
Active
Ingredients
not
Included
in
any
Previously
Registered
Products
1.
File
Symbol:
264
 
TNL.
Applicant:
Bayer
CropScience,
2
T.
W.
Alexander
Drive,
Research
Triangle
Park,
NC
27709.
Product
Name:
SCALA
Brand
SC
Pyrimethanil
Fungicide.
Fungicide.
Active
ingredient:
Pyrimethanil
at
37.4%.
Proposed
classification/
Use:
None.
For
control
of
plant
diseases
on
tree
nuts,
bulb
vegetables,
grapes,
stone
fruits
(
except
cherries)
pome
fruits,
tuberous
and
corm
vegetables,
strawberries,
and
tomatoes.
2.
File
Symbol:
264
 
TNU.
Applicant:
Bayer
CropScience.
Product
Name:
PYRIMETHANIL
Technical.
Fungicide.
Active
ingredient:
Pyrimethanil
at
98.5%.
Proposed
classification/
Use:
None.
For
formulation
of
fungicides
only.
3.
File
Symbol:
43813
 
EI.
Applicant:
Janssen
Pharmaceutica,
Inc.,
1125
Trenton­
Harbourton
Road,
Titusville,
NJ
08560
 
0200.
Product
Name:
PH066.
Fungicide.
Active
ingredient:
Pyrimethanil
at
37.4%.
Proposed
classification/
Use:
None.
For
postharvest
use
on
citrus
and
pome
fruit.

List
of
Subjects
Environmental
protection,
Pesticides
and
pest.

Dated:
December
20,
2002.
Debra
Edwards,
Acting
Director,
Registration
Division,
Office
of
Pesticide
Programs.

[
FR
Doc.
03
 
8
Filed
1
 
2
 
03;
8:
45
am]

BILLING
CODE
6560
 
50
 
S
ENVIRONMENTAL
PROTECTION
AGENCY
[
OPP
 
2002
 
0212;
FRL
 
7283
 
4]

Imazethapyr;
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
imazethapyr
in
or
on
various
food
commodities.
DATES:
Comments,
identified
by
docket
ID
number
OPP
 
2002
 
0212,
must
be
received
on
or
before
February
3,
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:
Jim
Tompkins,
Registration
Division
(
7505C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001;
telephone
number:
(
703)
305
 
5697;
e­
mail
address:
Tompkins.
Jim@
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
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
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
 
0212.
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.

VerDate
Dec<
13>
2002
15:
30
Jan
02,
2003
Jkt
200001
PO
00000
Frm
00022
Fmt
4703
Sfmt
4703
E:\
FR\
FM\
03JAN1.
SGM
03JAN1
371
Federal
Register
/
Vol.
68,
No.
2
/
Friday,
January
3,
2003
/
Notices
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
providing
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
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
 
0212.
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
 
0212.
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
 
0212.
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
 
0212.
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
VerDate
Dec<
13>
2002
15:
30
Jan
02,
2003
Jkt
200001
PO
00000
Frm
00023
Fmt
4703
Sfmt
4703
E:\
FR\
FM\
03JAN1.
SGM
03JAN1
372
Federal
Register
/
Vol.
68,
No.
2
/
Friday,
January
3,
2003
/
Notices
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.

Dated:
December
20,
2002.
Debra
Edwards,
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.

BASF
Corporation
PP
1E6268
EPA
has
received
a
pesticide
petition
(
PP
1E6268)
from
BASF
Corporation,
P.
O.
Box
400,
Princeton,
NJ
08543
 
0400
proposing
pursuant
to
section
408(
d)
of
the
Federal
Food,
Drug,
and
Cosmetic
Act,
21
U.
S.
C.
346a(
d),
to
amend
40
CFR
part
180
by
establishing
an
import
tolerance
for
the
sum
of
the
residues
of
the
herbicide
imazethapyr,
2­[
4,5­
dihydro­
4­
methyl­
4­(
1­
methylethyl)­
5­
oxo­
1H­
imidazol­
2­
yl]­
5­
ethyl­
3­
pyridine­
carboxylic
acid)
as
its
free
acid
or
its
ammonium
salt
(
calculated
as
the
acid),
and
its
metabolite
2­[
4,5­
dihydro­
4­
methyl­
4­(
1­
methylethyl­
5­
oxo­
1Himidazol
2­
yl]­
5­(
1­
hydroxyethyl)­
3­
pyridinecarboxylic
acid
in
or
on
the
raw
agricultural
commodity
canola
seed
at
0.1
part
per
million
(
ppm).
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.

A.
Residue
Chemistry
1.
Plant
metabolism.
The
qualitative
nature
of
the
residues
of
imazethapyr
in
canola
is
adequately
understood.
Based
on
studies
conducted
on
soybean,
edible
and
forage
legumes,
corn
and
canola,
parent
imazethapyr
and
common
metabolite
CL
288511
are
the
only
residues
of
concern
for
tolerance
setting
purposes.
2.
Analytical
method.
Practical
analytical
methods
for
detecting
and
measuring
imazethapyr
residues
of
concern
in
canola
are
submitted
to
EPA
with
this
petition.
The
analytical
methods
for
canola
seed
are
based
on
gas
chromatography
and
capillary
electrophoresis
with
limits
of
quantitation
(
LOQ)
of
0.05
ppm.
Measurement
of
imazethapyr
residues
in
canola
oil
and
meal
are
accomplished
by
gas
chromatography
with
LOQ
of
0.05
ppm.
These
validated
methods
are
appropriate
for
the
enforcement
purposes
of
this
petition.
3.
Magnitude
of
residues.
A
total
of
13
field
trials
were
conducted
with
imazethapyr
and
its
metabolite
on
canola
in
1992,
1993,
1994,
and
1999
at
several
different
use
rates
and
timing
intervals
to
represent
the
use
patterns,
conditions
and
areas
of
use
of
this
product
in
Canada.
Apparent
residues
of
imazethapyr
(
CL
263499)
and
metabolite
CL
288511
in
all
canola
seed
samples
were
below
the
LOQ
of
0.05
ppm
regardless
of
rate
or
days
after
treatment
sampled.

B.
Toxicological
Profile
A
complete,
valid
and
reliable
database
of
mammalian
and
genetic
toxicology
studies
supports
the
proposed
tolerance
for
imazethapyr
on
canola.
This
database
was
previously
reviewed
by
EPA
in
support
of
the
tolerance
petitions
and
registration
of
imazethapyr
on
soybeans,
legume
vegetables,
corn,
alfalfa,
and
peanuts.
1.
Acute
toxicity.
Imazethapyr
technical
is
considered
to
be
nontoxic
(
Toxicity
Category
IV)
to
the
rat
by
the
oral
route
of
exposure.
In
an
acute
oral
toxicity
study
in
rats,
the
LD50
value
of
imazethapyr
technical
was
greater
than
5,000
milligrams/
kilogram
body
weight
(
mg/
kg
bwt)
for
males
and
females.
The
results
from
an
acute
dermal
toxicity
study
in
rabbits
indicate
that
imazethapyr
is
slightly
toxic
(
Toxicity
Category
III)
to
rabbits
by
the
dermal
route
of
exposure.
The
dermal
LD50
value
of
imazethapyr
technical
was
greater
than
2,000
mg/
kg
bwt
for
both
male
and
female
rabbits.
Imazethapyr
technical
is
considered
to
be
non­
toxic
(
Toxicity
Category
IV)
to
the
rat
by
the
respiratory
route
of
exposure.
The
4
 
hour
LC50
value
was
greater
than
3.27
milligram/
liter
(
mg/
L)
(
analytical)
and
greater
than
4.21
mg/
L
(
gravimetric)
for
both
males
and
females.
Imazethapyr
technical
was
shown
to
be
non­
irritating
to
rabbit
skin
(
Toxicity
Category
IV)
and
mildly
irritating
to
the
rabbit
eye
(
Toxicity
Category
III).
Based
on
the
results
of
a
dermal
sensitization
study
(
Buehler),
imazethapyr
technical
is
not
considered
a
sensitizer
in
guinea
pigs.
2.
Genotoxicity.
Imazethapyr
technical
was
tested
in
a
battery
of
four
in
vitro
and
one
in
vivo
genotoxicity
assays
measuring
several
different
endpoints
of
potential
genotoxicity.
Collective
results
from
these
studies
indicate
that
imazethapyr
does
not
pose
a
mutagenic
or
genotoxic
risk.
3.
Reproductive
and
developmental
toxicity.
The
developmental
toxicity
study
in
Sprague
Dawley
rats
conducted
with
imazethapyr
technical
showed
no
evidence
of
developmental
toxicity
or
teratogenic
effects
in
fetuses.
Thus,
imazethapyr
is
neither
a
developmental
toxicant
nor
a
teratogen
in
the
rat.
The
no
observable
adverse
effect
level
(
NOAEL)
for
maternal
toxicity
was
375
mg/
kg
bwt/
day,
based
on
clinical
signs
of
toxicity
in
the
dams
(
e.
g.,
excessive
salivation)
at
1,125
mg/
kg
bwt/
day.
Imazethapyr
technical
did
not
exhibit
developmental
toxicity
or
teratogenic
effects
at
maternal
dosages
up
to
and
including
1,125
mg/
kg
bwt/
day,
the
highest
dose
tested.
Results
from
a
developmental
toxicity
study
in
New
Zealand
White
rabbits
with
imazethapyr
technical
also
indicated
no
evidence
of
developmental
toxicity
or
teratogenicity.
Thus,
imazethapyr
technical
is
neither
a
developmental
toxicant
nor
a
teratogen
in
the
rabbit.
The
NOAEL
for
maternal
toxicity
was
300
mg/
kg
bwt/
day,
based
on
decreased
food
consumption
and
body
weight
gain,
abortion,
gastric
ulceration
and
death
at
1,000
mg/
kg
bwt/
day,
the
next
highest
dose
tested.
The
NOAEL
for
developmental
toxicity
and
teratogenic
effects
was
determined
to
be
>
1,000
mg/
kg
bwt/
day
based
on
no
developmental
toxicity
or
fetal
malformations
associated
with
the
administration
of
all
doses.

VerDate
Dec<
13>
2002
15:
30
Jan
02,
2003
Jkt
200001
PO
00000
Frm
00024
Fmt
4703
Sfmt
4703
E:\
FR\
FM\
03JAN1.
SGM
03JAN1
373
Federal
Register
/
Vol.
68,
No.
2
/
Friday,
January
3,
2003
/
Notices
The
results
from
the
2
 
generation
reproduction
toxicity
study
in
rats
with
imazethapyr
technical
support
a
NOAEL
for
reproductive
toxicity
of
10,000
ppm
(
equivalent
to
800
mg/
kg
bwt/
day).
The
NOAEL
for
non­
reproductive
parameters
(
i.
e.
decreased
weanling
body
weights)
is
5,000
ppm.
4.
Subchronic
toxicity.
A
short­
term
(
21
 
day)
dermal
toxicity
study
in
rabbits
was
conducted
with
imazethapyr
technical.
No
dermal
irritation
or
abnormal
clinical
signs
were
observed
at
dose
levels
up
to
and
including
1,000
mg/
kg
bwt/
day
(
highest
dose
tested),
supporting
a
NOAEL
for
dermal
irritation
and
systemic
toxicity
of
1,000
mg/
kg
bwt/
day.
In
a
subchronic
(
13
 
week)
dietary
toxicity
study
in
rats
with
imazethapyr
technical,
no
signs
of
systemic
toxicity
were
noted,
supporting
a
NOAEL
of
10,000
ppm
the
highest
concentration
tested
(
equivalent
to
820
mg/
kg
bwt/
day).
In
a
subchronic
(
13
 
week)
dietary
toxicity
study
in
dogs
with
imazethapyr
technical,
no
signs
of
systemic
toxicity
were
noted,
supporting
a
NOAEL
of
10,000
ppm
(
equivalent
to
250
mg/
kg
bwt/
day),
the
highest
concentration
tested.
5.
Chronic
toxicity.
A
1
 
year
dietary
toxicity
study
was
conducted
with
imazethapyr
technical
in
Beagle
dogs
at
dietary
concentrations
of
0,
1,000,
5,000,
and
10,000
ppm.
In
this
study,
the
NOAEL
for
systemic
toxicity
was
1,000
ppm
(
equivalent
to
25
mg/
kg
bwt/
day),
based
on
slight
anemia,
i.
e.,
decreased
red
cell
parameters
observed
at
5,000
and
10,000
ppm
concentrations.
No
treatment­
related
histopathological
lesions
were
observed
at
any
dietary
concentration,
including
the
highest
concentration
tested
(
10,000
ppm).
In
a
2
 
year
chronic
dietary
oncogenicity
and
toxicity
study
in
rats
conducted
with
imazethapyr
technical,
the
NOAEL
for
oncogenicity
and
chronic
systemic
toxicity
was
10,000
ppm
(
equivalent
to
500
mg/
kg
bwt/
day),
the
highest
concentration
tested.
An
18
 
month
chronic
dietary
oncogenicity
and
toxicity
study
in
mice
with
imazethapyr
technical
supports
a
NOAEL
for
oncogenicity
of
10,000
ppm,
the
highest
concentration
tested
(
equivalent
to
1,500
mg/
kg
bwt/
day),
and
a
NOAEL
for
chronic
systemic
toxicity
of
5,000
ppm
(
equivalent
to
750
mg/
kg
bwt/
day),
based
on
decreased
body
weight
gain
in
both
sexes).
EPA
has
classified
imazethapyr
as
negative
for
carcinogenicity
(
evidence
of
non­
carcinogenicity
for
humans)
based
on
the
absence
of
treatment­
related
tumors
in
acceptable
carcinogenicity
studies
in
both
rats
and
mice.
6.
Animal
metabolism.
The
rat,
goat,
and
hen
metabolism
studies
indicate
that
the
qualitative
nature
of
the
residues
of
imazethapyr
in
animals
is
adequately
understood.
In
three
rat
metabolism
studies
conducted
with
radiolabeled
imazethapyr
technical,
the
major
route
of
elimination
of
the
herbicide
was
through
rapid
excretion
in
urine
and
to
a
much
lesser
extent
in
feces.
In
the
first
study,
almost
100%
of
the
administered
material
was
recovered
in
excreta
within
96
hours
(
89
 
95%
in
urine,
6
 
11%
in
feces).
The
major
residue
in
urine
and
feces
was
parent
compound.
Approximately
2%
of
the
dose
was
metabolized
and
excreted
as
the
ahydroxyethyl
derivative
of
imazethapyr.
In
the
second
study,
the
test
material
was
rapidly
and
completely
eliminated
unchanged
in
the
urine
within
72
hours
of
dosing.
After
24
hours,
92.1%
of
radioactivity
was
excreted
in
the
urine
with
4.67%
in
the
feces.
There
was
no
significant
bioaccumulation
of
radioactivity
in
the
tissues
from
this
rat
metabolism
study
(<
0.01
ppm
after
24
hours).
In
the
third
study,
four
groups
treated
with
radiolabeled
imazethapyr
readily
excreted
>
95%
of
the
test
material
in
the
urine
and
feces
within
48
hours.
A
high
percentage
(
97
 
99%)
of
the
test
material
was
excreted
in
the
urine
as
unchanged
parent,
the
remainder
as
the
a­
hydroxyethyl
derivative
of
imazethapyr.
For
all
three
studies,
the
major
route
of
elimination
of
the
herbicide
in
rats
was
through
rapid
excretion
of
unchanged
parent
compound
in
urine.
It
is
clear
that
imazathapyr
and
its
related
residues
do
not
accumulate
in
tissues
and
organs.
In
the
goat
metabolism
study,
parent
14C­
imazethapyr
was
dosed
to
lactating
goats
at
0.25
ppm
and
1.25
ppm.
Results
showed
14C­
residues
of
<
0.01
ppm
in
milk
and
<
0.05
ppm
in
leg
muscle,
loin
muscle,
blood,
fat,
liver
and
kidney.
Laying
hens
dosed
at
0.5
ppm
and
2.5
ppm
with
14C­
imazethapyr
showed
14Cresidues
of
<
0.05
ppm
in
eggs
and
all
tissues
(
blood,
muscle,
skin/
fat,
liver
and
kidney).
Additional
animal
metabolism
studies
have
been
conducted
with
CL
288511
(
main
metabolite
in
treated
crops
fed
to
livestock)
in
both
laying
hens
and
lactating
goats.
These
studies
have
been
repeated
to
support
subsequent
use
extensions
on
crops
used
as
livestock
feed
items
which
would
theoretically
result
in
a
higher
dosing
of
imazethapyr
derived
residues
to
livestock
(
i.
e.,
corn,
alfalfa).
In
these
studies,
lactating
goats
dosed
at
42
ppm
of
14C­
CL
288511
showed
14C­
residues
of
<
0.01
ppm
in
milk,
leg
muscle,
loin
muscle
and
omental
fat.
14C­
Residues
in
blood
were
mostly
<
0.01
ppm
but
reached
0.01
ppm
on
two
of
the
treatment
days.
14CResidue
levels
in
the
liver
and
kidney
were
0.02
and
0.09
ppm,
respectively.
Laying
hens
dosed
at
10.2
ppm
of
14Cimazethapyr
showed
14C­
residues
of
<
0.01
ppm
in
eggs
and
all
tissues
(
blood,
muscle,
skin/
fat,
liver
and
kidney).
14Cimazethapyr
or
14C­
CL
288511
ingested
by
either
laying
hens
or
lactating
goats
was
excreted
within
48
hours
of
dosing.
These
studies
indicate
that
parent
imazethapyr
and
CL
288511­
related
residues
do
not
accumulate
in
milk
or
edible
tissues
of
the
ruminant.
7.
Metabolite
toxicology.
Metabolism
studies
in
soybean,
peanut,
corn,
alfalfa,
and
canola
indicate
that
the
only
significant
metabolites
are
the
ahydroxyethyl
derivative
of
imazethapyr,
CL
288511
and
its
glucose
conjugate
CL
182704.
The
a­
hydroxyethyl
metabolite
has
also
been
identified
in
minor
quantities
in
the
previously
submitted
rat
metabolism
studies
and
in
goat
and
hen
metabolism
studies.
No
additional
toxicologically
significant
metabolites
were
detected
in
any
of
the
plant
or
animal
metabolism
studies.
8.
Endocrine
disruption.
Collective
organ
weight
data
and
histopathological
findings
from
the
2
 
generation
rat
reproductive
study,
as
well
as
from
the
subchronic
and
chronic
toxicity
studies
in
three
different
animal
species
demonstrate
no
apparent
estrogenic
effects
or
treatment­
related
effects
of
imazethapyr
on
the
endocrine
system.

C.
Aggregate
Exposure
1.
Dietary
exposure.
The
potential
dietary
exposure
to
imazethapyr
has
been
calculated
from
the
proposed
tolerance
for
use
on
rice
and
previously
established
tolerances
for
peanuts,
legume
vegetables,
soybeans,
alfalfa,
endive,
lettuce,
and
corn.
This
very
conservative
chronic
dietary
exposure
estimate
used
the
proposed
tolerance
of
0.5
ppm
for
rice,
and
tolerance
values
of
0.1
ppm
for
peanuts,
0.1
ppm
for
legume
vegetables,
0.1
ppm
for
soybeans,
3.0
ppm
for
alfalfa,
0.1
ppm
for
endive
(
escarole),
0.1
ppm
for
lettuce,
and
0.1
ppm
for
corn.
In
addition,
these
estimates
assume
that
100%
of
these
crops
contain
imazethapyr
residues.
In
support
of
this
import
tolerance
petition,
a
proposed
tolerance
of
0.1
ppm
for
canola
would
not
be
expected
to
contribute
significantly
to
this
dietary
risk
assessment.
i.
Food.
Potential
exposure
to
residues
of
imazethapyr
in
food
will
be
restricted
to
intake
of
rice,
peanuts,
legume
vegetables,
soybeans,
alfalfa
(
sprouts),
endive,
lettuce,
and
corn.
Using
the
assumptions
discussed
above,
the
VerDate
Dec<
13>
2002
15:
30
Jan
02,
2003
Jkt
200001
PO
00000
Frm
00025
Fmt
4703
Sfmt
4703
E:\
FR\
FM\
03JAN1.
SGM
03JAN1
374
Federal
Register
/
Vol.
68,
No.
2
/
Friday,
January
3,
2003
/
Notices
Theoretical
Maximum
Residue
Concentration
(
TMRC)
values
of
imazethapyr
were
calculated
for
the
U.
S.
general
population
and
subgroups.
Based
on
the
tolerances
given
above,
the
TMRC
values
for
each
group
are:
 
0.000419
mg/
kg
bwt/
day
for
the
general
U.
S.
population;
 
0.001104
mg/
kg
bwt/
day
for
all
infants
(<
1
year);
 
0.001298
mg/
kg
bwt/
day
for
nonnursing
infants;
 
0.000870
mg/
kg
bwt/
day
for
children
1
to
6
years
of
age;
and
 
0.000610
mg/
kg
bwt/
day
for
children
7
to
12
years
of
age.
The
TMRC
values
indicate
that
nonnursing
infants
are
the
most
highly
exposed
population
subgroup.
ii.
Drinking
water.
As
a
screeninglevel
assessment
for
aggregate
exposure,
EPA
evaluates
a
Drinking
Water
Level
of
Comparison
(
DWLOC),
which
is
the
maximum
concentration
of
a
chemical
in
drinking
water
that
would
be
acceptable
in
light
of
total
aggregate
exposure
to
that
chemical.
In
1990,
EPA
set
the
Reference
Dose
(
RfD)
for
imazethapyr
at
0.25
mg/
kg
bwt/
day,
based
on
the
NOAEL
from
the
1
 
year
dietary
toxicity
study
in
dogs
of
25
mg/
kg
bwt/
day
and
a
100­
fold
uncertainty
factor.
Based
on
the
chronic
RfD
of
0.25
mg/
kg
bwt/
day
and
EPA's
default
factors
for
body
weight
and
drinking
water
consumption,
the
DWLOCs
have
been
calculated
to
assess
the
potential
dietary
exposure
from
residues
of
imazethapyr
in
water.
For
the
adult
population,
the
chronic
DWLOC
was
8,735
parts
per
billion
(
ppb)
and
for
children
the
DWLOC
was
estimated
to
be
2,491
ppb.
Chronic
drinking
water
exposure
analyses
were
calculated
for
imazethapyr
using
EPA
screening
models
Screening
Concentration
in
Ground
Water
(
SCI­
GROW)
for
ground
water
and
Generic
Expected
Environmental
Concentration
(
GENEEC)
for
surface
water).
The
SCI­
GROW
value
is
16.54
ppb
and
the
calculated
peak
GENEEC
value
is
5.96
ppb
by
aerial
application.
For
the
U.
S.
adult
population,
the
estimated
exposures
of
imazethapyr
residues
in
ground
water
and
surface
water
are
approximately
0.19%
and
0.07%,
respectively,
of
the
DWLOC.
The
estimated
exposures
of
children
to
imazethapyr
residues
in
ground
water
and
surface
water
are
approximately
0.66%,
and
0.24%,
respectively,
of
the
DWLOC.
Therefore,
the
exposures
to
drinking
water
from
imazethapyr
use
are
negligible.
2.
Non­
dietary
exposure.
Imazethapyr
products
are
not
currently
registered
or
requested
to
be
registered
for
residential
use;
therefore
the
estimate
of
residential
exposure
is
not
relevant
to
this
tolerance
petition.

D.
Cumulative
Effects
Imazethapyr
is
a
member
of
the
imidazolinone
class
of
herbicides.
Other
compounds
of
this
class
are
registered
for
use
in
the
U.
S.
However,
the
herbicidal
activity
of
the
imidazolinones
is
due
to
the
inhibition
of
acetohydroxyacid
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
the
imidazolinone
compounds
in
animals.
BASF
is
aware
of
no
information
to
indicate
or
suggest
that
imazethapyr
has
any
toxic
effects
on
mammals
that
would
be
cumulative
with
those
of
any
other
chemical.
Therefore,
for
the
purposes
of
this
tolerance
petition
no
assumption
has
been
made
with
regard
to
cumulative
exposure
with
other
compounds
having
a
common
mode
of
action.

E.
Safety
Determination
1.
U.
S.
population.
The
RfD
represents
the
level
at
or
below
which
daily
aggregate
exposure
over
a
lifetime
will
not
pose
appreciable
risks
to
human
health.
In
1990,
EPA
set
the
RfD
for
imazethapyr
at
0.25
mg/
kg
bwt/
day,
based
on
the
NOAEL
from
the
1
 
year
dietary
toxicity
study
in
dogs
of
25
mg/
kg
bwt/
day
and
a
100­
fold
uncertainty
factor.
The
chronic
dietary
exposure
of
0.000419
mg/
kg
bwt/
day
for
the
general
U.
S.
population
will
utilize
only
0.2%
of
the
RfD
of
0.25
mg/
kg
bwt/
day.
EPA
generally
has
no
concern
for
exposures
below
100%
of
the
RfD.
Due
to
the
low
toxicity
of
imazethapyr,
an
acute
exposure
dietary
risk
assessment
is
not
warranted.
The
complete
and
reliable
toxicity
database,
the
low
toxicity
of
the
active
ingredient,
and
the
results
of
the
chronic
dietary
exposure
risk
assessment
support
the
conclusion
that
there
is
a
``
reasonable
certainty
of
no
harm''
from
the
proposed
use
of
imazethapyr
on
imidazolinone
tolerant
rice
and
canola.
2.
Infants
and
children.
The
conservative
dietary
exposure
estimates
of
all
registered
uses
including
the
proposed
tolerance
for
rice
show
exposures
of
0.001104,
0.000440,
0.000870,
and
0.000610
mg/
kg
bwt/
day
which
will
utilize
0.4,
0.2,
0.3,
and
0.2%
of
the
RfD
for
all
infants
(<
1
year),
nursing
infants,
children
1­
6
years,
and
children
7­
12
years,
respectively.
The
chronic
dietary
exposures
for
nonnursing
infants,
the
most
highly
exposed
subgroup,
will
utilize
only
0.5%
of
the
RfD.
Results
from
the
2
 
generation
reproduction
study
in
rats
and
the
developmental
toxicity
studies
in
rabbits
and
rats
indicate
no
increased
sensitivity
to
developing
offspring
when
compared
to
parental
toxicity.
These
results
also
indicate
that
imazethapyr
is
neither
a
developmental
toxicant
nor
a
teratogen
in
either
the
rat
or
rabbit.
Therefore,
an
additional
safety
factor
is
not
warranted,
and
the
RfD
of
0.25
mg/
kg
bwt/
day,
which
utilizes
a
100­
fold
safety
factor
is
appropriate
to
ensure
a
reasonable
certainty
of
no
harm
to
infants
and
children.

F.
International
Tolerances
There
are
no
Codex
maximum
residue
levels
established
or
proposed
for
residues
of
imazethapyr
on
canola.

[
FR
Doc.
03
 
7
Filed
1
 
2
 
03;
8:
45
am]

BILLING
CODE
6560
 
50
 
S
ENVIRONMENTAL
PROTECTION
AGENCY
[
FRL
 
7435
 
5]

Proposed
CERCLA
Section
122(
h)
Administrative
Agreement
for
Recovery
of
Past
Costs
for
the
Johnstown
Landfill
Site,
Town
of
Johnstown,
Fulton
County,
NY
AGENCY:
Environmental
Protection
Agency.
ACTION:
Notice;
request
for
public
comment.

SUMMARY:
In
accordance
with
section
122(
i)
of
the
Comprehensive
Environmental
Response,
Compensation,
and
Liability
Act
of
1980,
as
amended
(``
CERCLA''),
42
U.
S.
C.
9622(
i),
notice
is
hereby
given
by
the
U.
S.
Environmental
Protection
Agency
(``
EPA''),
Region
II,
of
a
proposed
administrative
agreement
pursuant
to
section
122(
h)
of
CERCLA,
42
U.
S.
C.
9622(
h),
for
recovery
of
past
response
costs
concerning
the
Johnstown
Landfill
Site
(``
Site'')
located
in
the
Town
of
Johnstown,
Fulton
County,
New
York.
The
settlement
requires
the
settling
parties,
the
City
of
Johnstown,
New
York;
Gloversville­
Johnstown
Joint
Sewer
Board;
Milligan
&
Higgins,
Division
of
Hudson
Industries;
Simco
Leather
Corporation;
Johnstown
Leather
Corporation;
Crescent
Leather
Finishing
Co.,
Inc.;
and
Pearl
Leather
Finishers,
Inc.,
to
pay
the
sum
total
of
$
202,125
in
reimbursement
of
EPA's
past
response
costs
at
the
Site.
The
settlement
includes
a
covenant
not
to
sue
the
settling
parties
pursuant
to
section
107(
a)
of
CERCLA,
42
U.
S.
C.
9607(
a),
in
exchange
for
their
payment
of
monies.
For
thirty
(
30)
days
following
VerDate
Dec<
13>
2002
15:
30
Jan
02,
2003
Jkt
200001
PO
00000
Frm
00026
Fmt
4703
Sfmt
4703
E:\
FR\
FM\
03JAN1.
SGM
03JAN1
