Document ID: EPA-HQ-OPP-2002-0188-0001
Agency: epa
Document Type: Notice
Title: Availability of the Risk Assessment on FQPA Tolerance Reassessment Progress of  the TRED 
Hexazimone
Posted Date: 2002-10-23T04:00Z

65118
Federal
Register
/
Vol.
67,
No.
205
/
Wednesday,
October
23,
2002
/
Notices
submitted
by
Roquette
in
its
Lycasin
80/
55
petition
regarding
numerous
studies
relating
to
the
safety
of
the
ingredient,
including
reports
on:
Digestion,
absorption,
distribution
and
excretion;
acute
oral
toxicity,
subchronic
toxicity,
genotoxicity,
reproduction,
biological
tolerance,
human
exposure,
and
laxation
effects.
1.
Acute
toxicity.
The
acute
oral
toxicity
of
HSH
has
been
evaluated.
The
acute
oral
lethal
dose
(LD50)
of
HSH
is
greater
than
10
grams/
kilogram
(g/
kg).
2.
Genotoxicty.
As
stated
in
Roquette's
GRAS
submission
of
Lycasin
80/
55,
HSH
is
nonmutagenic
and
nonclastogenic
in
short­
term
in
vivo,
and
in
vitro
studies.
3.
Reproductive
and
developmental
toxicity.
Again
as
noted
in
Roquette's
GRAS
submission
of
Lycasin
80/
55
HSH
products,
when
administered
to
rats
over
3­
generations,
produce
no
significant
effects
on
reproduction.
4.
Subchronic
toxicity.
In
Roquette's
GRAS
submission
for
Lycasin
80/
55,
it
is
noted
that
when
administered
orally
to
rats
and
dogs
in
amounts
of
5
g/
kg
to
15
g/
kg
of
body
weight
per
day
for
90
days,
HSH
produced
no
toxicologically
meaningful
effects
which
could
not
be
accounted
for
by
the
presence
of
sorbitol.
The
possible
treatment
related
effects
are
aggregates
in
the
renal
pelvis
of
some
rats,
diarrhea
in
most
dogs,
and
minimal
ectasia
in
the
renule
tubules
of
some
dogs.
5.
Chronic
toxicity.
HSH
is
used
extensively
in
foods.
Grain
Processing
Corporation
is
not
aware
of
any
chronic
toxic
effects
associated
with
this
product.
6.
Animal
metabolism.
The
GRAS
submission
for
Lycasin
80/
55
developed
by
Roquette
Freres
states
that
over
96%
of
HSH
(Lycasin
80/
55)
is
broken
down
by
the
mammalian
digestive
system
into
the
GRAS
substances,
glucose
and
sorbitol,
the
remaining
4%
is
in
the
form
of
maltitol.
One
half
of
the
maltitol
is
excreted
in
the
feces
and
the
majority
of
the
remainder
is
excreted
in
the
urine.
Within
the
first
2
hours
after
oral
administration
of
HSH
(Lycasin
80/
55),
virtually
all
of
the
glucose
to
glucose
bonds
are
broken
down
in
the
digestive
system,
producing
a
resulting
mixture
of
glucose,
sorbitol,
and
maltitol.
Within
7
hours,
95%
of
the
total
maltitol,
is
broken
down
into
glucose
and
sorbitol.
Of
the
remaining
5%
of
maltitol,
2%
is
found
in
the
digestive
tube
and
fecal
contents,
less
than
1%
is
found
in
the
plasma,
and
approximately
1%
is
excreted
in
the
urine.
There
is
no
accumulation
of
maltitol
in
the
plasma,
liver,
kidneys,
or
spleen
of
rats
fed
13.5
g/
kg/
day
of
Lycasin
80/
55
for
10
days
irrespective
of
whether
measurements
are
made
12
hours
or
10
days
after
cessation
of
dosing.
Lycasin
80/
55
at
the
dose
levels
tested,
30
to
180
grams
per
day,
produces
no
significant
variations
in
the
clinical
chemical,
hematological
or
urinary
profile
of
humans
with
the
exception
of
glucose
and
insulin
peaks
which
are
less
than
50%
of
those
produced
by
equivalent
amounts
of
glucose,
and
50
to
90%
of
those
produced
by
sucrose.
The
only
significant
clinical
effects
are
flatulence
and
diarrhea,
which
can
be
accounted
for
by
the
presence
of
free
and
bound
sorbitol.
The
mean
laxative
threshold
in
adult
males
is
approximately
180
grams
per
day,
while
in
females
the
threshold
is
approximately
100
grams
per
day.
In
children,
the
threshold
is
approximately
60
grams
per
day,
about
half
that
of
adults.
7.
Metabolite
toxicology.
None
of
the
metabolites
of
HSH
are
considered
to
be
of
toxicological
significance
for
the
use
of
this
product
as
a
pesticide
inert
ingredient.
8.
Endocrine
disruption.
Grain
Processing
Corporation
is
not
aware
of
any
endocrine
disruption
with
the
use
of
this
product.

C.
Aggregate
Exposure
1.
Dietary
exposure.
This
product
is
already
used
extensively
in
foods.
Studies
have
shown
that
it
is
safe
even
when
consumed
at
levels
of
up
to
100
g/
day.
i.
Food.
As
a
pesticide
inert
ingredient
HSH
will
not
result
in
any
harmful
exposure.
The
proposed
use
will
not
result
in
any
dietary
exposure
beyond
what
is
currently
present
in
commonly
consumed
foods.
ii.
Drinking
water.
There
is
no
anticipated
human
exposure
to
HSH
through
drinking
water.
HSH
is
expected
to
be
degraded
by
soil
microorganisms
to
carbon
dioxide
and
water
before
it
reaches
surface
or
ground
water.
Moreover,
in
water,
HSH
hydrolyses
to
glucose
and
sorbitol.
2.
Non­
dietary
exposure.
No
significant
non­
dietary
human
exposure
to
HSH
is
anticipated.

D.
Cumulative
Effects
HSH
is
a
widely
used
food
ingredient,
is
readily
digested
by
humans,
and
there
are
no
cumulative
effects.
Except
for
possible
occupational
exposure
of
the
pesticide
mixer/
loader/
applicator,
the
proposed
use
of
HSH
will
not
result
in
the
exposure
of
other
persons.
E.
Safety
Determination
1.
U.
S.
population.
The
proposed
use
of
HSH
does
not
pose
a
safety
concern
for
the
U.
S.
population
due
to
the
nontoxic
nature
of
the
compound
and
the
absence
of
exposure.
2.
Infants
and
children.
Infants
and
children
will
not
be
exposed
to
HSH
from
its
proposed
use
as
a
pesticide
inert
ingredient.

F.
International
Tolerances
Grain
Processing
Corporation
is
unaware
of
any
international
tolerances
for
this
product.
HSH
was
developed
by
a
Swedish
company
in
the
1960's
and
has
been
widely
used
by
the
food
industry
for
many
years,
especially
in
confectionery
products.
Roquette's
petition
indicates
that
Roquette's
Lycasin
products
have
been
approved
for
use
in
food
in
Europe
since
1963,
as
indicated
below.

Country
Year
of
Approval
Sweden
1963
(reaffirmed
in
1975)

Switzerland
1968
Norway
1975
Finland
1975
(reaffirmed
in
1980)

Denmark
1976
[FR
Doc.
02–
26993
Filed
10–
22–
02;
8:
45
am]

BILLING
CODE
6560–
50–
S
ENVIRONMENTAL
PROTECTION
AGENCY
[OPP–
2002–
0188;
FRL–
7199–
7]

Availability
of
the
Risk
Assessments
on
FQPA
Tolerance
Reassessment
Progress
and
Tolerance
Reassessment
Decision
(TRED)
for
Hexazinone
AGENCY:
Environmental
Protection
Agency
(EPA).

ACTION:
Notice.

SUMMARY:
This
notice
announces
the
availability
of
EPA's
tolerance
reassessment
decision
and
related
documents
for
hexazinone
including
the
Hexazinone
Overview,
Hexazinone
Summary,
Hexazinone
Decision
Document
(TRED),
and
supporting
risk
assessment
documents.
EPA
has
reassessed
the
25
tolerances,
or
legal
limits,
for
residues
of
hexazinone
in
or
on
raw
agricultural
commodities.
These
tolerances
are
now
considered
safe
under
the
Federal
Food,
Drug,
and
Cosmetic
Act
(FFDCA),
as
amended
by
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65119
Federal
Register
/
Vol.
67,
No.
205
/
Wednesday,
October
23,
2002
/
Notices
the
Food
Quality
Protection
Act
(FQPA)
of
1996.
DATES:
Comments
on
the
tolerance
reassessment
decision
for
hexazinone,
must
be
received
by
EPA
on
or
before
November
22,
2002.
In
the
absence
of
substantive
comments,
the
tolerance
reassessment
decision
will
be
considered
final.
Comments
on
the
human
health
and
ecological
effects
risk
assessments
for
hexazinone,
must
be
received
by
EPA
on
or
before
November
22,
2002.
ADDRESSES:
Comments
may
be
submitted
by
mail,
electronically,
or
in
person.
Please
follow
the
detailed
instructions
for
each
method
as
provided
in
the
SUPPLEMENTARY
INFORMATION
section.
To
ensure
proper
receipt
by
EPA,
it
is
imperative
that
you
identify
docket
ID
number
OPP–
2002–
0188
in
the
subject
line
on
the
first
page
of
your
response.
FOR
FURTHER
INFORMATION
CONTACT:
Dirk
V.
Helder,
Special
Review
and
Reregistration
Division
(7508C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460;
telephone
number:
(703)
305–
4610;
email
address:
helder.
dirk@
epa.
gov.
SUPPLEMENTARY
INFORMATION:

I.
General
Information
A.
Does
this
Action
Apply
to
Me?
This
action
is
directed
to
the
public
in
general,
but
will
be
of
interest
to
a
wide
range
of
stakeholders,
including
environmental,
human
health,
and
agricultural
advocates;
the
chemical
industry;
pesticide
users;
and
members
of
the
public
interested
in
the
use
of
pesticides.
The
Agency
has
not
attempted
to
describe
all
the
persons
or
entities
who
may
be
interested
in
or
affected
by
this
action.
If
you
have
questions
in
this
regard,
consult
the
persons
listed
under
FOR
FURTHER
INFORMATION
CONTACT.

B.
How
Can
I
Get
Additional
Information,
Including
Copies
of
this
Document
and
Other
Related
Documents?
1.Electronically.
You
may
obtain
electronic
copies
of
this
document,
and
certain
other
related
documents
that
might
be
available
electronically,
from
the
EPA
Internet
Home
Page
at
http://
www.
epa.
gov/.
To
access
this
document,
on
the
Home
Page
select
``
Laws
and
Regulations,
''
``
Regulations
and
Proposed
Rules,
''
and
then
look
up
the
entry
for
this
document
under
the
``
Federal
Register—
Environmental
Documents.
''
You
can
also
go
directly
to
the
Federal
Register
listings
at
http://
www.
epa.
gov/
fedrgstr/.
You
can
obtain
copies
of
the
TRED
and
related
documents
discussed
in
this
notice
on
EPA's
website
at
http://
www.
epa.
gov/
pesticides/
reregistration/
status.
htm.
Information
on
pesticide
reregistration
and
tolerance
reassessment,
including
the
purpose
and
status
of
Agency
programs
to
complete
Reregistration
Eligibility
Decisions
(REDs),
Interim
REDs,
and
Tolerance
Reassessment
Decisions
(TREDs),
is
available
at
http://
www.
epa.
gov/
pesticides/
reregistration.
General
information
is
available
on
the
Office
of
Pesticide
Programs'
home
page,
http://
www.
epa.
gov/
pesticides/.
2.
In
person.
The
Agency
has
established
an
official
record
for
this
action
under
docket
ID
number
OPP–
2002–
0188.
The
official
record
consists
of
the
documents
specifically
referenced
in
this
action,
and
other
information
related
to
this
action,
including
any
information
claimed
as
Confidential
Business
Information
(CBI).
This
official
record
includes
the
documents
that
are
physically
located
in
the
docket,
as
well
as
the
documents
that
are
referenced
in
those
documents.
The
public
version
of
the
official
record
does
not
include
any
information
claimed
as
CBI.
The
public
version
of
the
official
record,
which
includes
printed,
paper
versions
of
any
electronic
comments
submitted
during
an
applicable
comment
period
is
available
for
inspection
in
the
Public
Information
and
Records
Integrity
Branch
(PIRIB),
Rm.
119,
Crystal
Mall
#2,
1921
Jefferson
Davis
Hwy.,
Arlington,
VA,
from
8:
30
a.
m.
to
4
p.
m.,
Monday
through
Friday,
excluding
legal
holidays.
The
PIRIB
telephone
number
is
(703)
305–
5805.

C.
How
and
to
Whom
Do
I
Submit
Comments?
You
may
submit
comments
through
the
mail,
in
person,
or
electronically.
To
ensure
proper
receipt
by
EPA,
it
is
imperative
that
you
identify
docket
ID
number
OPP–
2002–
0188
in
the
subject
line
on
the
first
page
of
your
response.
1.
By
mail.
Submit
your
comments
to:
Public
Information
and
Records
Integrity
Branch
(PIRIB),
Information
Resources
and
Services
Division
(7502C),
Office
of
Pesticide
Programs
(OPP),
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460.
2.
In
person
or
by
courier.
Deliver
your
comments
to:
Public
Information
and
Records
Integrity
Branch
(PIRIB),
Information
Resources
and
Services
Division
(7502C),
Office
of
Pesticide
Programs
(OPP),
Environmental
Protection
Agency,
Rm.
119,
Crystal
Mall
#2,
1921
Jefferson
Davis
Hwy.,
Arlington,
VA.
The
PIRIB
is
open
from
8:
30
a.
m.
to
4
p.
m.,
Monday
through
Friday,
excluding
legal
holidays.
The
PIRIB
telephone
number
is
(703)
305–
5805.
3.
Electronically.
You
may
submit
your
comments
electronically
by
e­
mail
to:
opp­
docket@
epa.
gov,
or
you
can
submit
a
computer
disk
as
described
in
this
unit.
Do
not
submit
any
information
electronically
that
you
consider
to
be
CBI.
Avoid
the
use
of
special
characters
and
any
form
of
encryption.
Electronic
submissions
will
be
accepted
in
WordPerfect
6.1/
8.0/
9.0
or
ASCII
file
format.
All
comments
in
electronic
form
must
be
identified
by
docket
ID
number
OPP–
2002–
0188.
Electronic
comments
may
also
be
filed
online
at
many
Federal
Depository
Libraries.

D.
How
Should
I
Handle
CBI
that
I
Want
to
Submit
to
the
Agency?

Do
not
submit
any
information
electronically
that
you
consider
to
be
CBI.
You
may
claim
information
that
you
submit
to
EPA
in
response
to
this
document
as
CBI
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.
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
version
of
the
official
record.
Information
not
marked
confidential
will
be
included
in
the
public
version
of
the
official
record
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.
Offer
alternative
ways
to
improve
the
notice
or
collection
activity.
7.
Make
sure
to
submit
your
comments
by
the
deadline
in
this
notice.

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Federal
Register
/
Vol.
67,
No.
205
/
Wednesday,
October
23,
2002
/
Notices
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.
What
Action
is
the
Agency
Taking?
EPA
has
reassessed
the
risks
associated
with
current
food
uses
of
the
pesticide
hexazinone,
reassessed
25
existing
tolerances,
and
reached
a
tolerance
reassessment
and
risk
management
decision.
The
Agency
is
issuing
for
comment
the
resulting
report
on
FQPA
tolerance
reassessment
progress,
including
the
Hexazinone
Overview,
Hexazinone
Summary,
Hexazinone
Decision
Document
(TRED),
and
supporting
risk
assessment
documents.
EPA
must
review
tolerances
and
tolerance
exemptions
that
were
in
effect
when
FQPA
was
enacted
in
August
1996,
to
ensure
that
these
existing
pesticide
residue
limits
for
food
and
feed
commodities
meet
the
safety
standard
established
by
the
new
law.
Tolerances
are
considered
reassessed
once
the
safety
finding
has
been
made
or
a
revocation
occurs.
EPA
has
reviewed
and
made
the
requisite
safety
finding
for
the
tolerances
and
exemptions
included
in
this
notice.
EPA
completed
the
hexazinone
Reregistration
Eligibility
Decision
(RED)
prior
to
the
1996
enactment
of
the
FQPA;
therefore,
while
no
reregistration
decision
is
required
at
present,
risks
from
non­
occupational
exposure
to
hexazinone
through
food,
drinking
water,
and
residential
uses
must
be
reassessed.
There
are
no
residential
uses
of
hexazinone.
The
Agency
has
reassessed
the
25
tolerances
for
hexazinone
and
determined
that
residues
in
food
and
drinking
water
are
not
expected
to
pose
risk
concerns.
Because
existing
data
were
inadequate
to
calculate
residue
estimates
for
pasture
and
rangeland
grass
and
grass
hay,
EPA
constructed
the
maximum
theoretical
dietary
burden
(MTDB)
of
hexazinone
to
livestock
using
protective
assumptions
for
the
contributions
of
other
hexazinone
treated
feed
items.
Thus,
tolerances
for
meats
and
milk
can
be
reassessed.
Additional
field
trial
data
for
grass
forage
and
grass
hay,
as
well
as
rotational
crop
studies
for
corn
and
wheat
are
required.
Because
of
the
relatively
low
volume
of
use
on
pasture
and
rangeland,
data
from
these
confirmatory
studies
are
not
expected
to
significantly
change
current
dietary
risk
estimates.
Some
tolerances
may
be
revised
once
additional
data
has
been
submitted
to
and
reviewed
by
the
Agency.
The
current
tolerance
expression
for
hexazinone
in
40
CFR
180.396
is
for
``
combined
residues
of
the
herbicide
hexazinone
(3­
cyclohexyl­
6­
(dimethylamino)­
1­
methyl­
1,3,5­
triazine­
2,4(
1H,
3H)­
dione)
and
its
metabolites,
calculated
as
hexazinone.
''
The
tolerance
expression
should
be
modified
to
include
specific
metabolites
A,
B,
C,
D,
and
E,
identified
by
the
appropriate
chemical
name.
Final
tolerances
are
being
proposed
as
part
of
this
Tolerance
Reassessment
Decision
(TRED).
In
addition,
occupational
and
ecological
risk
management
decisions
were
made
as
part
of
the
1994
hexazinone
RED.
EPA
works
with
affected
parties
to
reach
the
tolerance
reassessment
decisions.
The
Agency
therefore
is
issuing
the
hexazinone
decision
as
a
final
decision
with
a
public
comment
period.
All
comments
received
during
the
public
comment
period
will
be
considered
by
the
Agency.
If
any
comment
significantly
affects
the
Agency's
decision,
EPA
will
publish
an
amendment
to
the
decision
in
the
Federal
Register.
In
the
absence
of
substantive
comments,
the
tolerance
reassessment
decisions
reflected
here
will
be
considered
final.

List
of
Subjects
Environmental
protection,
Chemicals,
Pesticides
and
pests.

Dated:
October
4,
2002.
Betty
Shackleford,
Acting
Director,
Special
Review
and
Reregistration
Division,
Office
of
Pesticide
Programs.
[FR
Doc.
02–
26577
Filed
10–
22–
02;
8:
45
am]

BILLING
CODE
6560–
50–
S
ENVIRONMENTAL
PROTECTION
AGENCY
[OPP–
2002–
0223;
FRL–
7274–
1]

Availability
of
the
Report
on
FQPA
Tolerance
Reassessment
Progress
and
Risk
Management
Decision
(TRED)
for
Metolachlor
AGENCY:
Environmental
Protection
Agency
(EPA).
ACTION:
Notice.

SUMMARY:
This
notice
announces
the
availability
of
the
report
on
the
Food
Quality
Protection
Act
(FQPA)
tolerance
reassessment
progress
and
Risk
Management
Decision
(TRED)
for
metolachlor
for
public
comment.
EPA
has
reassessed
the
81
tolerances,
or
legal
limits,
established
for
residues
of
metolachlor
in/
on
raw
agricultural
commodities
(RACs).
These
tolerances
are
now
considered
safe
under
the
Federal
Food,
Drug,
and
Cosmetic
Act
(FFDCA),
as
amended
by
the
FQPA
of
1996.

DATES:
Comments,
identified
by
docket
ID
number
OPP–
2002–
0223,
must
be
received
on
or
before
November
22,
2002.

ADDRESSES:
Comments
may
be
submitted
by
mail,
electronically,
or
in
person.
Please
follow
the
detailed
instructions
for
each
method
as
provided
in
Unit
I.
of
the
SUPPLEMENTARY
INFORMATION.
To
ensure
proper
receipt
by
EPA,
it
is
imperative
that
you
identify
docket
ID
number
OPP–
2002–
0223
in
the
subject
line
on
the
first
page
of
your
response.

FOR
FURTHER
INFORMATION
CONTACT:
Anne
Overstreet,
Special
Review
and
Reregistration
Division
(7508C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460;
telephone
number:
(703)
308–
8068;
fax
number:
(703)
308–
8005;
e­
mail
address:
overstreet.
anne@
epa.
gov.

SUPPLEMENTARY
INFORMATION:

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

This
action
is
directed
to
the
public
in
general,
but
will
be
of
interest
to
a
wide
range
of
stakeholders,
including
environmental,
human
health,
and
agricultural
advocates;
the
chemical
industry;
pesticide
users;
and
members
of
the
public
interested
in
the
use
of
pesticides.
The
Agency
has
not
attempted
to
describe
all
the
persons
or
entities
who
may
be
interested
in
or
affected
by
this
action.
If
you
have
questions
in
this
regard,
consult
the
person
listed
under
FOR
FURTHER
INFORMATION
CONTACT.

B.
How
Can
I
Get
Additional
Information,
Including
Copies
of
this
Document
and
Other
Related
Documents?

1.
Electronically.
You
may
obtain
electronic
copies
of
this
document,
and
certain
other
related
documents
that
might
be
available
electronically,
from
the
EPA
Internet
Home
Page
at
http://
www.
epa.
gov/.
To
access
this
document,
on
the
Home
Page
select
``
Laws
and
Regulations,
''
``
Regulations
and
Proposed
Rules,
''
and
then
look
up
the
entry
for
this
document
under
the
``
Federal
Register—
Environmental
Documents.
''
You
can
also
go
directly
to
the
Federal
Register
listings
at
http://
www.
epa.
gov/
fedrgstr/.
You
can
obtain
copies
of
the
TRED
and
related
documents
discussed
in
this
notice
on
EPA's
website
at
http://
www.
epa.
gov/
pesticides/
reregistration/
status.
htm.

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