Document ID: EPA-HQ-OPP-2003-0260-0001
Agency: epa
Document Type: Notice
Title: S-Metolachlor; Notice of Filing a Pesticide Petition to Establish a Tolerance for a Certain Pesticide Chemical in or on Food
Posted Date: 2003-08-13T04:00Z

48373
Federal
Register
/
Vol.
68,
No.
156
/
Wednesday,
August
13,
2003
/
Notices
system.
Pyraclostrobin
also
acts
curatively
to
prevent
the
increase
and
spread
of
fungal
infections
by
inhibiting
mycelial
growth
and
sporulation
on
the
leaf
surface.
BAS
500F
inhibits
spore
germination,
germ
tube
growth
and
penetration
into
the
host
tissues.
The
EPA
is
currently
developing
methodology
to
perform
cumulative
risk
assessments.
At
this
time,
there
is
no
available
data
to
determine
whether
BAS
500F
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,
pyraclostrobin
does
not
appear
to
produce
a
toxic
metabolite
produced
by
other
substances.

E.
Safety
Determination.
U.
S.
population.
Adding
the
proposed
uses
to
those
crops
already
on
the
pyraclostrobin
label,
aggregate
exposure
to
adults
in
the
U.
S.
population
utilized
at
most
67%
of
the
aPAD
and
40%
of
the
cPAD.
Therefore,
no
harm
to
the
overall
U.
S.
population
would
result
from
the
use
of
pyraclostrobin
on
the
proposed
and
existing
label
crops.
Infants
and
children.
All
subpopulations
based
on
age
were
considered.
The
highest
potential
exposure
was
predicted
for
children
age
1­
6.
Using
the
FQPA
safety
factor
of
3X
when
appropriate,
the
addition
of
the
proposed
crops
to
those
on
the
label
would
use
less
than
1%
of
the
aPAD
and
use
89%
of
the
cPAD
for
children
age
1
 
6.
BASF
concludes
that
there
is
reasonable
certainty
that
no
harm
will
result
to
infants
or
children
from
aggregate
exposure
to
pyraclostrobin
residues
on
the
proposed
and
existing
label
crops.

F.
International
Tolerances.
Maximum
Residue
Levels
(
MRLs)
have
been
established
for
pyraclostrobin
in
Canada.
No
MRLs
have
been
established
by
the
Codex
Alimentarius
Commission.
[
FR
Doc.
03
 
20641
Filed
8
 
12
 
03;
8:
45
am]

BILLING
CODE
6560
 
50
 
S
ENVIRONMENTAL
PROTECTION
AGENCY
[
OPP
 
2003
 
0260];
FRL
 
7320
 
9]

S­
Metolachlor;
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
 
2003
 
0260,
must
be
received
on
or
before
September
12,
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:
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
(
NAICS
111)
 
Animal
production
(
NAICS
112)
 
Food
manufacturing
(
NAICS
311)
 
Pesticide
manufacturing
(
NAICS
32532)
This
listing
is
not
intended
to
be
exhaustive,
but
rather
provides
a
guide
for
readers
regarding
entities
likely
to
be
affected
by
this
action.
Other
types
of
entities
not
listed
in
this
unit
could
also
be
affected.
The
North
American
Industrial
Classification
System
(
NAICS)
codes
have
been
provided
to
assist
you
and
others
in
determining
whether
this
action
might
apply
to
certain
entities.
If
you
have
any
questions
regarding
the
applicability
of
this
action
to
a
particular
entity,
consult
the
person
listed
under
FOR
FURTHER
INFORMATION
CONTACT.

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

1.
Docket.
EPA
has
established
an
official
public
docket
for
this
action
under
docket
ID
number
OPP
 
2003
 
0260.
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
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
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Federal
Register
/
Vol.
68,
No.
156
/
Wednesday,
August
13,
2003
/
Notices
that
public
comments,
whether
submitted
electronically
or
on
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
 
2003
 
0260.
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
 
2003
 
0260.
Incontrast
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
 
2003
 
0260.
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
 
2003
 
0260.
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
pesticide
petitions
as
follows
proposing
the
establishment
and/
or
amendment
of
regulations
for
residues
of
a
certain
pesticide
chemical
in
or
on
various
food
commodities
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13AUN1
48375
Federal
Register
/
Vol.
68,
No.
156
/
Wednesday,
August
13,
2003
/
Notices
under
section
408
of
the
Federal
Food,
Drug,
and
Cosmetic
Act
(
FFDCA),
21
U.
S.
C.
346a.
EPA
has
determined
that
these
petitions
contain
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
these
petitions.
Additional
data
may
be
needed
before
EPA
rules
on
the
petitions.

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

Dated:
August
4,
2003.
Debra
Edwards,
Director,
Registration
Division,
Office
of
Pesticide
Programs.

Summary
of
Petition
The
petitioner's
summary
of
the
pesticide
petitions
is
printed
below
as
required
by
FFDCA
section
408(
d)(
3).
The
summary
of
the
petitions
was
prepared
by
Syngenta
Crop
Protection,
410
Swing
Road,
Greeensboro,
NC
276419,
and
represents
the
view
of
the
Syngenta
Crop
Protection.
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.

Syngenta
Crop
Protection
PP
7E4916,
8E5029,
8E5030,
9E6055,
and
2E6374
EPA
has
received
pesticide
petitions
(
7E4916,
8E5029,
8E5030,
9E6055,
and
2E6374)
from
the
Interregional
Research
Project
Number
4
(
IR­
4),
681
U.
S.
Highway
#
1
South,
North
Brunswick,
NJ
08902
proposing
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
by
establishing
tolerances
for
combined
residues
of
s­
metolachlor
and
its
metabolites,
determined
as
the
derivatives,
2­(
2­
ethyl­
6­
methylphenyl)
amino­
1­
propanol
and
4­
(
2­
ethyl­
6­
methylphenyl)­
2­
hydroxy­
5­
methyl­
3­
morpholine,
each
expressed
as
the
parent
compound
s­
metolachlor
in
or
on
the
following
raw
agricultural
commodities:
1.
PP
4E4420
proposes
the
establishment
of
tolerances
for
pepper,
bell
and
pepper,
nonbell
at
0.50
part
per
million
(
ppm).
2.
PP
7E4916
proposes
the
establishment
of
a
tolerance
for
carrot,
root
and
horseradish
at
0.1
ppm.
3.
PP
8E5029
proposes
the
establishment
of
a
tolerance
for
rhubarb
at
0.1
ppm.
4.
PP
8E5030
proposes
the
establishment
of
a
tolerance
for
swiss
chard
at
0.1
ppm.
5.
PP
9E6055
proposes
the
establishment
of
a
tolerance
for
asparagus
at
0.1
ppm.
6.
PP
2E6374
proposes
the
establishment
of
a
tolerance
for
onion,
green
at
0.2
ppm.
EPA
has
determined
that
the
petitions
contain
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
supports
granting
of
the
petitions.
Additional
data
may
be
needed
before
EPA
rules
on
the
petitions.

A.
Residue
Chemistry
1.
Plant
metabolism.
[
The
qualitative
nature
of
S­
metolachlor
residues
in
plants
is
adequately
understood
based
upon
available
EPA
approved
corn,
potato,
and
soybean
metabolism
studies.
The
metabolism
of
S­
metolachlor
involves
conjugation
with
glutathione,
breakage
of
this
bond
to
form
the
mercaptan,
conjugation
of
the
mercaptan
with
glucuronic
acid,
hydrolysis
of
the
methyl
ether,
and
conjugation
of
the
resultant
alcohol
with
a
neutral
sugar.
EPA
has
determined
that
residues
of
concern
in
plants
include
parent
and
metabolites,
determined
as
the
derivatives
CGA­
37913
and
CGA­
49751.
2.
Analytical
method.
The
Pesticide
Analytical
Manual
(
PAM)
Vol.
II,
Pesticide
Regulation
Section
180.368
lists
a
gas
chromatography/
nitrogen
phosphorous
detector
(
GC/
NPD)
method
(
Method
1)
for
determining
residues
in
or
on
plants
and
a
gas
chromatography/
mass
spectrometry
methos
(
GC/
MSD)
method
for
determining
residues
in
livestock
commodities.
These
methods
determine
residues
of
S­
metolachlor
and
its
metabolites
as
either
CGA­
37913
or
CGA­
49751
following
acid
hydrolysis.
The
limit
of
quantitation
(
LOQ)
for
the
method
is
0.03
ppm
for
CGA­
37913
and
0.05
ppm
for
CGA­
49751.
3.
Magnitude
of
residues.
 
i.
Asparagus.
Magnitude
of
residue
trials
were
conducted
under
the
direction
of
IR­
4
in
EPA
regions
2,
5,
and
11
in
New
Jersey,
Michigan,
and
Washington.
Applications
were
made
pre­
emergence
to
dormant
asparagus
in
the
spring
and
samples
were
collected
for
analysis
16
days
after
application.
There
were
no
detectable
residues
found
in
asparagus
at
harvest.
ii.
Carrot.
Field
trials
were
conducted
in
Florida,
Michigan,
and
New
York
to
support
the
proposed
tolerance
for
Smetolachlor
in
or
on
carrots
grow
on
high
organic
matter
(
muck)
soils.
iii.
Green
onion.
Magnitude
of
residue
trials
were
completed
by
IR­
4
in
New
York,
California,
and
Michigan
(
EPA
region
1,
10,
and
5,
respectively).
One
post­
emergence
broadcast
application
was
made
when
the
onions
had
2
true
leaves.
Marketable
green
onion
plants
were
collected
43
to
45
days
following
the
application.
Maximum
residues
found
were
0.168
ppm.
iv.
Rhubarb
and
Swiss
chard.
As
the
EPA
review
announced
in
the
October
2002
TRED
has
confirmed
that
a
0.1
ppm
tolerance
is
appropriate
for
Smetolachlor
in
celery
and
as
celery
is
the
representative
crop
for
the
Leafy
Petiole
Subgroup,
IR­
4
has
proposed
tolerances
be
established
for
rhubarb
and
Swiss
chard.

B.
Toxicological
Profile
1.
Acute
toxicity.
[
The
data
base
for
acute
toxicity
for
S­
metolachlor
is
complete.
S­
metolachlor
is
moderately
acutely
toxic
(
Toxicity
Category
III)
by
the
oral
and
dermal
route
and
relatively
non­
toxic
(
Toxicity
category
IV)
by
the
inhalation
route.
It
causes
slight
eye
irritation
(
Toxicity
Category
III)
and
is
non­
irritating
dermally
(
Toxicity
Category
IV);
the
active
ingredient
was
found
to
be
positive
in
a
dermal
sensitization
test
but
this
effect
is
mitigated
in
end­
use
product
formulations.]
2.
Genotoxicty.
The
data
base
for
Smetolachlor
has
been
deemed
to
be
adequate
by
EPA.
Gene
mutation
studies
(
Guideline
870.5100),
micronucleus
(
Guideline
870.5395),
and
unscheduled
DNA
synthesis
(
Guideline
870.5550)
studies
have
recently
been
reviewed
and
approved
by
EPA.
There
is
no
evidence
of
a
mutagenic
or
cytogentic
effect
in
vivo
or
in
vitro
with
S­
metolachlor.
3.
Reproductive
and
developmental
toxicity.
The
data
base
for
developmental
and
reproductive
toxicity
for
S­
metolachlor
are
considered
complete
according
to
EPA
reviews.
The
prenatal
developmental
studies
in
the
rat
and
rabbit
with
Smetolachlor
revealed
no
evidence
of
a
qualitative
or
quantitative
susceptibility
in
fetal
animals.
No
significant
developmental
toxicity
was
observed
in
most
studies
even
at
the
highest
doses
tested.
In
a
two­
generation
reproduction
study,
there
was
no
evidence
of
parental
or
reproductive
toxicity
at
the
highest
dose
tested
(
80
mg/
kg/
day).
The
results
indicate
that
S­
metolachlor
is
not
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13AUN1.
SGM
13AUN1
48376
Federal
Register
/
Vol.
68,
No.
156
/
Wednesday,
August
13,
2003
/
Notices
embryotoxic
or
teratogenic
in
either
species
at
maternally
toxic
doses.
4.
Subchronic
toxicity.
In
a
90
 
day
dietary
study
in
rats
with
S­
metolachlor,
no
effects
were
observed
in
male
or
females
at
208
and
236
mg/
kg/
day,
respectively.
In
another
90
 
day
dietary
study
in
rats,
decreased
body
weight,
reduced
food
consumption
and
food
efficiency
in
both
sexes
and
increased
kidney
weight
in
males
at
150
mg/
kg/
day;
the
NOAEL
was
15
mg/
kg/
day.
A
90
 
day
dog
study
with
S­
metolachlor
in
dogs
has
been
accepted
by
EPA;
no
effects
were
observed
in
males
and
females
at
62
mg/
kg/
day
and
74
mg/
kg/
day,
respectively,
the
highest
doses
tested.
5.
Chronic
toxicity.
A
combined
chronic
toxicity/
carcinogenic
study
in
the
rat
satisfies
the
requirements
for
both
the
chronic
toxicity
and
carcinogenicity
studies.
No
significant
chronic
toxicity
was
found
in
either
rats
or
dogs.
In
the
rat,
a
decrease
in
body
weight
was
observed
at
the
highest
dose
tested.
In
the
chronic
dog
study
that
supports
S­
metolachlor,
the
only
adverse
effect
was
decreased
body
weight
gain
in
females
at
33
mg/
kg/
day;
the
NOAEL
was
10
mg/
kg/
day.
6.
Animal
metabolism.
In
animals,
Smetolachlor
is
extensively
absorbed,
rapidly
metabolized
and
almost
totally
eliminated
in
the
excreta
of
rats,
goats,
and
poultry.
Metabolism
in
animals
proceeds
through
common
Phase
1
intermediates
and
glutathione
conjugation.
7.
Metabolite
toxicology.
The
metabolism
of
S­
metolachlor
has
been
well
characterized
in
standard
FIFRA
metabolism
studies.
S­
metolachlor
does
not
readily
undergo
dealkylation
to
form
an
aniline
or
quinone
imine
as
has
been
reported
for
other
members
of
the
chloroacetanilide
class
of
chemicals.
Therefore,
it
is
not
appropriate
to
include
S­
metolachlor
with
the
group
of
chloroacetanilides
that
readily
undergo
dealkylation,
producing
a
common
toxic
metabolite
(
quinone
imine).
New
toxicology
data
submitted
by
Syngenta
demonstrate
that
the
S­
metolachlor
metabolites
ethane
sulfonic
acid
(
CGA
354743)
and
oxanilic
acid
(
CGA
51202)
are
not
absorbed
by
mammalian
systems
and
/
or
have
a
significantly
lower
level
of
mammalian
toxicity
when
compared
to
parent.
8.
Endocrine
disruption.
SMetolachlor
does
not
belong
to
a
class
of
chemicals
known
or
suspected
of
having
adverse
effects
on
the
endocrine
system.
There
is
no
evidence
that
Smetolachlor
has
any
effect
on
endocrine
function
in
developmental
or
reproduction
studies.
Furthermore,
histological
investigation
of
endocrine
organs
in
the
chronic
dog,
rat
and
mouse
studies
did
not
indicate
that
the
endocrine
system
is
targeted
by
Smetolachlor
even
at
maximally
tolerated
doses
administered
for
a
lifetime.
There
is
no
evidence
that
Smetolachlor
bioaccumulates
in
the
environment.

C.
Aggregate
Exposure
1.
Dietary
exposure.
A
Tier
III/
IV
chronic
dietary
exposure
analysis
was
conducted
on
S­
metolachlor
using
field
trial
and
market
basket
survey
residues.
Field
trial
residues
were
adjusted
for
percent
of
crop
treated
whereas
market
basket
residues
were
not,
since
this
information
is
inherent
in
the
data.
The
percent
of
crop
treated
was
assumed
to
be
100%
for
all
commodities
for
which
no
percent
of
crop
treated
information
was
available.
The
chronic
assessment
was
conducted
for
S­
metolachlor
using
the
Dietary
Exposure
Evaluation
Model
(
DEEMTM,
version
7.76)
by
Exponent
and
food
consumption
information
from
USDA's
1994­
96
Continuing
Survey
of
Food
Intake
by
Individuals
(
CSFII)
and
the
Supplemental
CSFII
children's
survey
(
1998).
For
this
chronic
assessment,
the
field
trial
values
were
averaged
and
entered
into
the
DEEMTM
software.
Syngenta
Market
Basket
Survey
(
SMBS)
S­
metolachlor
data
were
available
for
the
following
commodities:
milk,
potatoes
and
tomatoes.
The
Syngenta
market
basket
survey
was
conducted
from
September
1999
through
September
2000.
Following
the
Agency
tier
ranking
system,
these
chronic
dietary
assessments
are
considered
as
Tier
III
(
utilizing
field
trial
data)
and
Tier
IV
(
utilizing
SMBS
and
PDP
data)
assessments.
S­
metolachlor
is
not
considered
acutely
toxic
and
therefore
acute
dietary
exposure
was
not
determined;
however,
in
the
October
2002
TRED
EPA
conducted
an
acute
assessment
of
the
majority
of
the
crops
included
in
this
petition
and
determined
acute
risks
to
be
<
1%
of
the
aPAD
in
the
most
exposed
population
subgroup.
The
chronic
RfD
for
S­
metolachlor
is
0.10
mg/
kg
body
weight/
day
and
is
based
on
a
one­
year
dog
study
with
a
NOEL
of
9.7
mg/
kg
body
weight/
day
and
a
safety
factor
of
100X.
No
additional
FQPA
safety
factor
is
required;
nor
was
applied
in
this
assessment.
i.
Food.
The
risk
from
chronic
dietary
exposure
to
S­
metolachlor
is
considered
to
be
very
low.
The
percentages
of
the
chronic
RfD
ranged
from
0.17%
for
Seniors
to
0.64%
for
Children
1
 
2
years
old,
theoretically
the
most
exposure
population
subgroup.
ii.
Drinking
water.
Other
potential
sources
of
exposure
of
the
general
population
to
residues
of
S­
metolachlor
are
residues
in
drinking
water
and
exposure
from
non­
occupational
sources.
The
degradation
of
Smetolachlor
is
microbially
mediated
with
an
aerobic
soil
metabolism
primary
half­
life
of
less
than
30
days
and
subsequently
soil
binding
predominates.
S­
metolachlor
Koc's
vary
from
110­
369.
S­
metolachlor
is
stable
to
hydrolysis
and
while
aqueous
and
soil
photolysis
occur,
they
are
not
expected
to
be
prominent
pathways
in
the
environment.
The
predominant
crop
for
Smetolachlor
is
corn
and
accordingly
an
Index
Reservoir
PRZM/
EXAMS
was
run
using
EPA's
standard
corn
scenario.
The
model
simulated
two
applications
to
the
same
plot:
pre­
emergence
(
2.67
kg
ai/
ha)
and
post­
emergence
(
1.50
kg
a.
i./
ha).
The
mean
annual
average
estimated
environmental
concentrations
(
EEC)
was
11.77
ppb.
It
should
be
noted
that
extensive
monitoring
data
suggests
that
this
EEC
is
a
conservative
estimate.
For
the
vast
majority
of
locations
sampled,
the
peak
measured
concentration
does
not
approach
12
ppb,
and
the
annual
average
would
be
expected
to
be
much
lower.
The
Chronic
drinking
water
levels
of
concern
(
DWLOC)
was
calculated
based
on
a
cRfD
of
0.097
mg/
kg/
day.
Nonnursing
infants
are
the
most
sensitive
subpopulation
and
their
DWLOC
is
estimated
to
be
544
ppb
which
corresponds
to
a
%
cRfD
value
of
2.2%
with
an
MOE
value
of
4621.
Thus,
the
DWLOC
is
considerably
higher
than
the
EEC
of
11.77
ppb
and
the
MOE
is
well
above
the
benchmark
value
of
100.
2.
Non­
dietary
exposure.
Smetolachlor
is
labeled
for
use
on
warmseason
turf
and
landscape
ornamentals.
Although,
it
is
primarily
used
on
sod
farms
and
commercial
landscape
ornamentals,
it
can
be
used
by
licensed
pest
control
operators
(
PCO)
or
lawn
care
operators
(
LCO)
on
residential
turf.
Since
S­
metolachlor
can
only
be
applied
to
warm­
season
turf
varieties
(
bermudagrass,
Zoysiagrass,
St.
Augustinegrass,
and
Centipedegrass),
its
use
on
turf
is
limited
to
the
southern
states.
Non­
dietary
residential
exposure
may
occur
to
homeowners
or
children
as
a
result
of
exposure
during
re­
entry
activities.
Using
surrogate
dislodgeable
foliar
residue
data,
and
conservative
standard
EPA
exposure
scenarios,
exposure
through
the
dermal
route
was
calculated.
Based
on
the
use
pattern,
which
restricts
to
number
of
application
to
one
per
year,
only
short­
term
risks
need
to
be
considered.
The
relevant
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48377
Federal
Register
/
Vol.
68,
No.
156
/
Wednesday,
August
13,
2003
/
Notices
toxicological
endpoint
for
short­
term
dermal
risks
is
the
NOEL
of
100
mg/
kg/
day
from
a
21
 
day
dermal
toxicity
study
in
rabbits.
No
acute
oral
hazard
has
been
identified
following
an
acute
exposure
to
S­
metolachlor
and,
therefore,
no
nondietary
assessment
is
needed.
The
short­
term
dermal
postapplication
risks
for
adults
and
children
are
acceptable,
ranging
from
520
to
870.
These
risk
estimates
exceed
the
EPA's
level
of
concern
for
S­
metolachlor
(
all
MOEs
are
greater
than
100).
Aggregate
exposure.
(
Drinking
Water
and
Dietary
Exposure).
Using
the
total
MOE
equation
for
the
determination
of
aggregate
chronic
exposure
(
food
and
drinking
water
only)
resulted
in
an
aggregate
MOET
of
>
4,000
for
the
most
sensitive
subpopulation,
non­
nursing
infants.
For
this
particular
subpopulation,
there
are
no
non­
dietary
exposure
contributions
to
the
MOET
aggregate
value.

D.
Cumulative
Effects
EPA
has
examined
the
common
mechanism
potential
for
S­
metolachlor
and
has
concluded
that
S­
metolachlor
should
not
be
included
with
some
pesticides
that
comprise
the
class
of
chloroacetanilides
included
in
a
``
Common
Mechanism
Group.''
Therefore,
a
cumulative
assessment
is
not
necessary
for
S­
metolachlor.

E.
Safety
Determination
1.
U.
S.
population.
Based
on
the
aggregate
assessment
described
above
and
the
completeness
and
reliability
of
the
toxicity
data,
it
is
concluded
that
aggregate
exposure
to
S­
metolachlor
(
including
the
proposed
uses)
in
food
will
utilize
less
than
0.1
percent
of
the
cRfD
for
the
U.
S.
population.
EPA
generally
has
no
concern
for
exposures
below
100
percent
of
the
RfD
because
the
RfD
represents
the
level
at
or
below
which
daily
aggregate
dietary
exposure
over
a
lifetime
will
not
pose
appreciable
risks
to
human
health.
Despite
the
potential
for
exposure
to
S­
metolachlor
in
drinking
water
and
from
non­
dietary,
non­
occupational
exposures,
the
assessment
presented
above
demonstrates
that
the
high
levels
of
safety
exist
for
current
and
proposed
uses
of
S­
metolachlor;
it
is
not
expected
that
aggregate
exposure
from
all
sources
will
exceed
100%
of
the
RfD.
Therefore,
one
can
conclude
there
is
a
reasonable
certainty
that
no
harm
will
result
from
aggregate
exposure
to
S­
metolachlor.
2.
Infants
and
children.
[
FFDCA
section
408
provides
that
EPA
may
apply
an
additional
safety
factor
for
infants
and
children
in
the
case
of
threshold
effects
to
account
for
pre­
and
post­
natal
toxicity
and
the
completeness
of
the
database.
Based
on
the
current
toxicological
data
requirements,
the
database
relative
to
pre­
and
post­
natal
effects
for
children
is
complete.
A
full
consideration
of
the
available
reproductive
toxicity
data
supporting
Smetolachlor
demonstrates
no
increased
sensitivity
to
infants
and
children.
Therefore,
it
is
concluded
that
an
additional
uncertainty
factor
is
not
warranted
to
protect
the
health
of
infants
and
children
and
that
the
cRfD
at
0.1
mg/
kg/
day
is
appropriate
for
assessing
aggregate
risk
to
infants
and
children
from
use
of
S­
metolachlor.
Based
on
the
aggregate
assessment
described
above,
the
percent
of
the
cRfD
that
will
be
utilized
by
aggregate
exposure
to
residues
of
S­
metolachlor
is
less
than
0.7
percent
for
all
children
subpopulations.
EPA
generally
has
no
concern
for
exposures
below
100%
of
the
RfD
because
the
RfD
represents
the
level
at
or
below
which
daily
aggregate
dietary
exposure
over
a
lifetime
will
not
pose
appreciable
risks
to
human
health.
Despite
the
potential
for
exposure
to
Smetolachlor
in
drinking
water
and
from
non­
dietary,
non­
occupational
exposure,
the
assessment
described
above
demonstrates
that
it
is
not
expected
that
aggregate
exposure
from
all
sources
provides
for
a
large
margin
of
safety
and
will
exceed
100%
of
the
RfD.
Therefore,
based
on
the
completeness
and
reliability
of
the
toxicity
data
and
the
exposure
assessment,
it
is
concluded
there
is
a
reasonable
certainty
that
no
harm
will
result
to
infants
and
children
from
aggregate
exposure
to
Smetolachlor
residues.

F.
International
Tolerances
There
are
no
Codex
Alimentarius
Commission
(
CODEX)
maximum
residue
levels
(
MRL's)
established
for
residues
of
S­
metolachlor
in
or
on
raw
agricultural
commodities.

[
FR
Doc.
03
 
20643
Filed
8
 
12
 
03;
8:
45
am]

BILLING
CODE
6560
 
50
 
S
ENVIRONMENTAL
PROTECTION
AGENCY
[
OPP
 
2003
 
0271;
FRL
 
7322
 
6]

Etoxazole;
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
 
2003
 
0271,
must
be
received
on
or
before
September
12,
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:
Daniel
Kenny,
Registration
Division
(
7505C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001;
telephone
number:
(
703)
305
 
7546;
e­
mail
address:
kenny.
dan@
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
(
NAICS
111)
 
Animal
Production
(
NAICS
112)
 
Food
Manufacturing
(
NAICS
311)
 
Pesticide
Manufacturing
(
NAICS
32532)]
This
listing
is
not
intended
to
be
exhaustive,
but
rather
provides
a
guide
for
readers
regarding
entities
likely
to
be
affected
by
this
action.
Other
types
of
entities
not
listed
in
this
unit
could
also
be
affected.
The
North
American
Industrial
Classification
System
(
NAICS)
codes
have
been
provided
to
assist
you
and
others
in
determining
whether
this
action
might
apply
to
certain
entities.
If
you
have
any
questions
regarding
the
applicability
of
this
action
to
a
particular
entity,
consult
the
person
listed
under
FOR
FURTHER
INFORMATION
CONTACT.

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

1.
Docket.
EPA
has
established
an
official
public
docket
for
this
action
under
docket
ID
number
OPP
 
2003
 
0271.
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
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