Document ID: EPA-HQ-OPP-2003-0097-0001
Agency: epa
Document Type: Notice
Title: Thiamethoxam; Notice of Filing a Pesticide Petition to Establish a Tolerance for a  Certain Pesticide Chemical in or on Food
Posted Date: 2003-04-02T05:00Z

16040
Federal
Register
/
Vol.
68,
No.
63
/
Wednesday,
April
2,
2003
/
Notices
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
 
0146.
Such
deliveries
are
only
accepted
during
the
docket's
normal
hours
of
operation
as
identified
in
Unit
I.
B.
1.

D.
How
Should
I
Handle
CBI
That
I
Want
to
Submit
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.
Offer
alternative
ways
to
improve
the
notice
or
collection
activity.
7.
Make
sure
to
submit
your
comments
by
the
deadline
in
this
document.
8.
To
ensure
proper
receipt
by
EPA,
be
sure
to
identify
the
docket
control
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.
Background
A.
What
Action
is
the
Agency
Taking?

This
notice
constitutes
and
announces
the
availability
of
the
TRED
for
tebuthiuron.
This
decision
has
been
developed
as
part
of
the
public
participation
process
that
EPA
and
the
U.
S.
Department
of
Agriculture
(
USDA)
are
using
to
involve
the
public
in
the
reassessment
of
pesticide
tolerances
under
FFDCA.
EPA
must
review
tolerances
and
tolerance
exemptions
that
were
in
effect
when
FQPA
was
enacted
in
August
1996,
to
ensure
these
existing
pesticide
residues
limits
for
food
and
feed
commodities
meet
the
safety
standard
of
the
new
law.
FFDCA
requires
EPA
to
review
all
the
tolerances
for
registered
chemicals
in
effect
on
or
before
the
date
of
the
enactment.
In
reviewing
these
tolerances,
the
Agency
must
consider,
among
other
things,
aggregate
risks
from
non­
occupational
sources
of
pesticide
exposure,
whether
there
is
increased
susceptibility
to
infants
and
children,
and
the
cumulative
effects
of
pesticides
with
a
common
mechanism
of
toxicity.
The
tolerances
are
considered
reassessed
once
the
safety
finding
has
been
made
or
a
revocation
occurs.
FFDCA
requires
that
the
Agency,
when
considering
whether
to
establish,
modify,
or
revoke
a
tolerance,
consider
``
available
information''
concerning
the
cumulative
effects
of
a
particular
pesticide's
residues
and
``
other
substances
that
have
a
common
mechanism
of
toxicity.''
As
indicated
above,
the
Agency
will
also
evaluate
the
cumulative
risk,
if
necessary,
posed
by
the
entire
group
of
chemicals
with
which
a
common
mechanism
of
toxicity
is
shared,
and
issues
a
final
tolerance
reassessment
decision
once
the
cumulative
assessment
for
that
group
is
completed.
At
this
time,
tebuthiuron
has
not
been
identified
as
sharing
a
common
mechanism
of
toxicity
and
is
not
scheduled
for
a
cumulative
risk
assessment.
The
tolerance
reassessment
program
is
being
conducted
under
Congressionally
mandated
time
frames,
and
EPA
recognizes
both
the
need
to
make
timely
tolerance
decisions
and
to
involve
the
public.
Therefore,
EPA
is
issuing
this
TRED
as
a
final
document
with
a
30
 
day
comment
period.
All
comments
will
be
considered
by
the
Agency.
If
any
comment
significantly
affects
a
TRED,
EPA
will
amend
the
TRED
by
publishing
the
amendment
in
the
Federal
Register.

B.
What
is
the
Agency's
Authority
for
Taking
this
Action?

The
authority
for
this
TRED
is
found
in
section
408(
q)
of
the
FFDCA,
21
U.
S.
C.
346a(
q).
Section
408(
q)
requires
EPA
to
review
tolerances
and
exemptions
for
pesticide
chemical
residues
in
effect
on
August
2,
1996,
to
determine
whether
the
tolerance
or
exemption
meets
the
requirements
of
408(
b)(
2)
or
(
c)(
2).
This
review
is
to
be
completed
by
August
3,
2006.

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

Dated:
March
19,
2003.
Lois
A.
Rossi,
Director,
Special
Review
and
Reregistration
Division,
Office
of
Pesticide
Programs.
[
FR
Doc.
03
 
7981
Filed
4
 
1
 
03;
8:
45
am]

BILLING
CODE
6560
 
50
 
S
ENVIRONMENTAL
PROTECTION
AGENCY
[
OPP
 
2003
 
0097;
FRL
 
7298
 
7]

Thiamethoxam;
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
 
0097,
must
be
received
on
or
before
May
2,
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:
Dani
Daniel,
Registration
Division
(
7505C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001;
telephone
number:
(
703)
305
 
5409;
e­
mail
address:
daniel.
dani@
epa.
gov.

SUPPLEMENTARY
INFORMATION:

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Federal
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/
Vol.
68,
No.
63
/
Wednesday,
April
2,
2003
/
Notices
I.
General
Information
A.
Does
this
Action
Apply
to
Me?

You
may
be
potentially
affected
by
this
action
if
you
are
an
agricultureal
producer,
food
manufacturer,
or
pesticide
manufactuer.
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.
EPA
Docket.
EPA
has
established
an
official
public
docket
for
this
action
under
docket
ID
number
OPP
 
2003
 
0097.
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
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
 
0097.
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
 
0097.
In
contrast
to
EPA's
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Federal
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/
Vol.
68,
No.
63
/
Wednesday,
April
2,
2003
/
Notices
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
 
0097.
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
 
0097.
Such
deliveries
are
only
accepted
during
the
docket's
normal
hours
of
operation
as
identified
in
Unit
I.
B.
1.

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

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

II.
What
Action
is
the
Agency
Taking?

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

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

Dated:
March
24,
2003.
Debra
Edwards,
Acting
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
Interregional
Research
Project
4
(
IR­
4)
and
represents
the
view
of
the
petitioners.
The
petition
summary
announces
the
availability
of
a
description
of
the
analytical
methods
available
to
EPA
for
the
detection
and
measurement
of
the
pesticide
chemical
residues
or
an
explanation
of
why
no
such
method
is
needed.

Interregional
Research
Project
4
(
IR­
4)

Syngenta
Crop
Ptotection
Inc.

PP
2E6505,
2E6363,
2E6508,
3E6524,
1E6349,
9F5051
and
0F6142
This
notice
is
a
summary
of
pesticide
petitions
proposing
the
establishment/
amendment
of
a
regulation
for
residues
of
thiamethoxam
and
its
metabolite
in
or
on
coffee
(
imported),
pecans,
leafy
vegetable
crop
group,
head
and
stem
brassica
subgroup,
leafy
brassica
subgroup,
succulent
beans,
stone
fruit
crop
group,
sunflower
seed,
peppermint
tops
and
spearmint
tops.
This
summary
was
prepared
by
the
petitioners.
EPA
has
received
seven
pesticide
petitions;
four
from
Interregional
Research
Project
4
(
IR­
4),
681
U.
S.
Highway
#
1
South,
North
Brunswick,
NJ
08902
 
3390,
PP
2E6505,
2E6363,
2E6508
and
3E6524
and
three
from
Syngenta
Crop
Protection
Inc.,
P.
O.
Box
18300,
Greensboro,
NC
27419
 
8300,
PP
0F6142,
1E6349,
and
9F5051
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
180.565
by
establishing
a
tolerance
for
residues
of
the
insecticide
thiamethoxam
[
3­(
chloro­
5­
thiazolyl)
methyl]
tetrahydro­
5­
methyl­
Nnitro
4H­
1,3,5­
oxadiazin­
4­
imine]
(
CAS
Reg.
No.
153719
 
23
 
4)
and
its
metabolite
N­(
2­
chloro­
thiazol­
5­
ylmethyl)­
N'­
methyl
­
N'­
nitroguanidine
in
or
on
the
agricultural
commodities:

A.
IR­
4
Petitions
l.
PP
2E6505
proposes
to
establish
tolerances
for
stone
fruits,
group
12
at
0.5
ppm.
2.
PP
2E6363
proposes
to
establish
tolerances
for
peppermint
and
spearmint,
tops
at
4.0
ppm.
3.
PP
2E6508
proposes
to
establish
tolerances
for
beans,
succulent
at
0.02
ppm.
4.
PP
3E6524
proposes
to
establish
tolerances
for
sunflower,
seed
at
0.02
ppm.

B.
Syngenta
Petitions
5.
PP
0F6142
proposes
to
establish
tolerances
for
pecans
at
0.02
ppm.
6.
PP
9F5051
proposes
to
establish
tolerances
for:

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Federal
Register
/
Vol.
68,
No.
63
/
Wednesday,
April
2,
2003
/
Notices
 
Leafy
vegetables,
group
4
at
2.0
ppm
 
Head
and
stem
brassica
vegetables,
subgroup
5A
at
1.0
ppm.

 
Leafy
brassica
vegetables,
subgroup
5B
at
2.0
ppm.
7.
PP
1E6349
proposes
to
establish
tolerances
for
imported
green
and
roasted
coffee
beans
and
instant
coffee
at
0.05
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
support
granting
of
the
petitions.
Additional
data
may
be
needed
before
EPA
rules
on
the
petitions.

A.
Residue
Chemistry
1.
Plant
metabolism.
The
primary
metabolic
pathways
of
thiamethoxam
in
plants
(
corn,
rice,
pears,
and
cucumbers)
were
similar
to
those
described
for
animals,
with
certain
extensions
of
the
pathway
in
plants.
Parent
compound
and
CGA
 
322704
were
the
major
residues
in
all
crops.
The
metabolism
of
thiamethoxam
in
plants
and
animals
is
understood
for
the
purposes
of
the
proposed
tolerances.
Parent
thiamethoxam
and
the
metabolite,
CGA
 
322704,
are
the
residues
of
concern
for
tolerance
setting
purposes.
2.
Analytical
method.
Syngenta
Crop
Protection
Inc.
has
submitted
practical
analytical
methodology
for
detecting
and
measuring
levels
of
thiamethoxam
in
or
on
raw
agricultural
commodities.
The
method
is
based
on
crop
specific
cleanup
procedures
and
determination
by
liquid
chromatography
with
either
ultraviolet
(
UV)
or
mass
spectroscopy
(
MS)
detection.
The
limit
of
detection
(
LOD)
for
each
analyte
of
this
method
is
1.25
nanogram
(
ng)
injected
for
samples
analyzed
by
UV
and
0.25
ng
injected
for
samples
analyzed
by
MS,
and
the
limit
of
quantitation
(
LOQ)
is
0.005
ppm
for
milk
and
juices
and
0.01
ppm
for
all
other
substrates.
3.
Magnitude
of
residues.
IR­
4
has
submitted
complete
residue
data
for
thiamethoxam
on
succulent
beans,
sunflower
seed,
peppermint
and
spearmint
tops
and
stone
fruits.
Syngenta
has
submitted
complete
residue
data
for
the
proposed
imported
coffee,
pecan,
leafy
vegetable,
head
and
stem
brassica
vegetables,
leafy
brassica
vegetables.
Details
of
the
Syngenta
residue
data
on
these
crops
were
provided
in
previously
published
Notices
of
Filing.
B.
Toxicological
Profile
1.
Acute
toxicity.
The
acute
oral
LD50
for
thiamethoxam
in
the
rat
is
1,563
milligrams/
kilogram
body
weight
(
mg/
kg
bwt).
The
acute
dermal
LD50
of
thiamethoxam
is
>
2000
mg/
kg
bwt.
Thiamethoxam
is
non­
toxic
at
atmospheric
concentrations
of
3.72
mg/
L.
Thiamethoxam
is
minimally
irritating
to
the
eye,
non­
irritating
to
skin
and
is
not
a
dermal
sensitizer.
In
an
acute
neurotoxicity
screening
study
in
rats
(
OPPTS
Harmonized
Guideline
870.6200),
the
no
observed
aderse
affect
level
(
NOAEL)
was
100
mg/
kg/
day
with
a
NOAEL
of
500
mg/
kg/
day
based
on
drooped
palpebral
closure,
decrease
in
rectal
temperature
and
locomotor
activity
and
increase
in
forelimb
grip
strength
(
males
only).
At
higher
dose
levels,
mortality,
abnormal
body
tone,
ptosis,
impaired
respiration,
tremors,
longer
latency
to
first
step
in
the
open
field,
crouched
over
posture,
gait
impairment,
hypo­
arousal,
decreased
number
of
rears,
uncoordinated
landing
during
the
righting
reflex
test,
slight
lacrimation
(
females
only)
and
higher
mean
average
input
stimulus
value
in
the
auditory
startle
response
test
(
males
only).
2.
Genotoxicty.
In
gene
mutation
studies
with
S.
typhimurium
and
E.
coli
(
OPPTS
Harmonized
Guidelines,
870.5100
and
870.5265),
there
was
no
evidence
of
gene
mutation
when
tested
up
to
5,000
µ
g/
plate
and
there
was
no
evidence
of
cytotoxicity.
In
a
gene
mutation
study
with
chinese
hamster
V79
cells
at
hypoxanthine
guanine
phophoribosyl
transferase
(
HGPRT)
focus
(
OPPTS
Harmonized
Guideline
870.5300)
there
was
no
evidence
of
a
gene
mutation
when
tested
up
to
the
solubility
limit.
In
a
CHO
cell
cytogenetics
study
(
OPPTS
Harmonized
Guideline
870.5375)
there
was
no
evidence
of
chromosomal
aberrations
when
tested
up
to
cytotoxic
or
solubility
limit
concentrations.
An
in
vivo
mouse
bone
marrow
micronucleus
study
(
OPPTS
Harmonized
Guideline
870.5395)
was
negative
when
tested
up
to
levels
of
toxicity
in
whole
animals;
however,
there
was
no
evidence
of
target
cell
cytotoxicity.
An
unscheduled
DNA
synthesis
(
UDS)
assay
(
OPPTS
Harmonized
Guideline
870.5550)
was
negative
when
tested
up
to
precipitating
concentrations.
3.
Reproductive
and
developmental
toxicity.
A
prenatal
developmental
study
in
the
rat
(
OPPTS
Harmonized
Guideline
870.3700)
resulted
in
maternal
and
developmental
NOAELs
of
30
mg/
kg/
day
and
200
mg/
kg/
day,
respectively.
The
maternal
lowest
observed
adverse
effect
level
(
LOAEL)
is
200
mg/
kg/
day
based
on
decreased
body
weight,
body
weight
gain
and
food
consumption.
The
developmental
LOAEL
was
750
mg/
kg/
day
based
on
decreased
fetal
body
weight
and
an
increased
incidence
of
skeletal
anomalies.
A
prenatal
developmental
study
in
the
rabbit
(
OPPTS
Harmonized
Guideline
870.3700)
resulted
in
maternal
and
developmental
NOAELs
of
50
mg/
kg/
day.
The
maternal
and
developmental
LOAEL
is
150
mg/
kg/
day.
The
maternal
LOAEL
is
based
on
maternal
deaths,
hemorrhagic
discharge,
decreased
body
weight
and
food
intake
during
the
dosing
period.
The
developmental
LOAEL
is
based
on
decreased
fetal
body
weights,
increased
incidence
of
post­
implantation
loss
and
a
slight
increase
in
the
incidence
of
a
few
skeletal
anomolies/
variations.
In
a
reproduction
and
fertility
effects
study
in
rats
(
OPPTS
Harmonized
Guideline
870.3800),
the
parental/
systemic
NOAEL
is
1.84
(
males),
202.06
(
females)
mg/
kg/
day;
the
reproductive
NOAEL
is
0.61
(
males),
202.06
(
females)
mg/
kg/
day
and
the
offspring
NOAEL
is
61.25
(
males),
79.20
(
females)
mg/
kg/
day.
The
parental/
systemic
LOAEL
is
61.25
(
males),
not
determined
(
females)
mg/
kg/
day
based
on
increased
incidence
of
hyaline
change
in
renal
tubules
in
F0
and
F1
males.
The
reproductive
LOAEL
is
1.84
(
males),
not
determined
(
females
)
mg/
kg/
day
based
on
increased
incidence
and
severity
of
tubular
atrophy
observed
in
testes
of
the
F1
generation
males.
The
offspring
LOAEL
is
158.32
(
males),
202.06
(
females)
mg/
kg/
day
based
on
reduced
body
weight
gain
during
the
lactation
period
in
all
litters.
4.
Subchronic
toxicity.
A
90
 
day
oral
toxicity
study
in
rats
(
OPPTS
Harmonized
Guideline
870.3100)
resulted
in
a
NOAEL
of
1.74
males
and
92.5
(
females)
mg/
kg/
day.
The
LOAEL
is
17.64
(
male)
and
182.1
(
female)
mg/
kg/
day
based
on
increased
incidence
of
hyaline
change
of
renal
tubules
epithelium
(
males),
fatty
change
in
adrenal
gland
of
females,
liver
changes
in
females,
all
at
the
LOAEL.
A
90
 
day
oral
toxicity
study
in
mice
(
OPPTS
Harmonized
Guideline
870.3100)
resulted
in
an
NOAEL
of
1.41
(
males)
and
19.2
(
females)
mg/
kg/
day.
The
LOAEL
was
14.3
(
male)
and
231
(
female)
mg/
kg/
day
based
on
increased
incidence
of
hepatocellular
hypertrophy.
At
higher
dose
levels:
Decrease
in
body
weight
and
body
weight
gain,
necrosis
of
individual
hepatocytes,
pigmentation
of
Kupffer
cells,
and
lymphocytic
infiltration
of
the
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Notices
liver
in
both
sexes;
slight
hematologic
effects
and
decreased
absolute
and
relative
kidney
weights
in
males;
and
ovarian
atrophy,
decreased
ovary
and
spleen
weights
and
increased
liver
weights
in
females.
In
a
90
 
day
oral
toxicity
study
in
dogs
(
OPPTS
Harmonized
Guideline
870.3150),
the
NOAEL
is
8.23
(
males)
and
9.27
(
females)
mg/
kg/
day.
The
LOAEL
is
32.0
(
male)
and
33.9
(
female)
mg/
kg/
day
based
on
slightly
prolonged
prothrombin
times
and
decreased
plasma
albumin
and
A/
G
ration
(
both
sexes);
decreased
calcium
levels
and
ovary
weights
and
delayed
maturation
in
the
ovaries
(
female);
decreased
cholesterol
and
phospholipid
levels,
testis
weights,
spermatogenesis,
and
spermatic
giant
cells
in
testes
(
male).
In
a
28
 
day
dermal
study
in
rats
(
OPPTS
Harmonized
Guideline
870.3200),
the
NOAEL
was
250
(
male)
and
60
(
female)
mg/
kg/
day.
The
LOAEL
was
1,000
(
male)
and
250
(
female)
mg/
kg/
day
based
on
increased
plasma
glucose,
triglyceride
levels,
and
alkaline
phosphatase
activity
and
inflammatory
cell
infiltration
in
the
liver
and
necrosis
if
single
hepatocytes
in
females
and
hyaline
change
in
renal
tubules
and
a
very
slight
reduction
in
body
weight
in
males.
At
higher
dose
levels
in
females,
chronic
tubular
lesions
in
the
kidneys
and
inflammatory
cell
infiltration
in
the
adrenal
cortex
were
observed.
In
a
subchronic
neurotoxicity
screening
study
in
rats
(
OPPTS
Harmonized
Guideline
870.6200)
the
NOAEL
was
95.4
(
male)
and
216.4
(
female)
mg/
kg/
day,
both
at
highest
dose
tested.
The
LOAEL
was
not
determined.
No
treatment
related
observations
at
any
dose
level.
LOAEL
was
not
achieved.
May
not
have
been
tested
at
sufficiently
high
dose
levels;
however,
a
new
study
is
not
required
because
the
weight
of
the
evidence
from
other
toxicity
studies
indicates
no
evidence
of
concern.
5.
Chronic
toxicity.
In
a
chronic
toxicity
study
in
dogs
(
OPPTS
Harmonized
Guideline
870.4100)
the
NOAEL
was
4.05
(
male)
and
4.49
(
female)
mg/
kg/
day.
The
LOAEL
was
21.0
(
male)
and
24.6
(
female)
mg/
kg/
day
based
on
increase
of
creatinine
in
both
sexes,
transient
decrease
in
food
consumption
in
females,
and
occasional
increase
in
urea
levels,
decrease
in
ALT,
and
atrophy
of
seminiferous
tubules
in
males.
In
a
mouse
carcinogenicity
study
(
OPPTS
Harmonized
Guideline
870.4200),
the
NOAEL
was
2.63
(
male)
and
3.68
(
female)
mg/
kg/
day.
The
LOAEL
was
63.8
(
male)
and
87.6
(
female)
mg/
kg/
day
based
on
hepatocyte
hypertrophy,
single
cell
necrosis,
inflammatory
cell
infiltration,
pigment
deposition,
foci
of
cellualr
alteration,
hyperplasia
of
kupffer
cells
and
increased
mitotic
activity,
also
an
increase
in
the
incidence
of
hepatocellular
adenoma
(
both
sexes).
At
higher
doses,
there
was
an
increase
in
the
incidence
of
hepatocelluar
adenocarcinoma
(
both
sexes)
and
the
number
of
animals
with
multiple
tumors,
evidence
of
carcinogenicity.
In
a
combined
chronic
caricinogenicity
study
in
rats
(
OPPTS
Harmonized
Guideline
870.4300)
the
NOAEL
was
21.0
(
male)
and
50.3
(
female)
mg/
kg/
day.
The
LOAEL
was
63.0
(
male)
and
255
(
female)
mg/
kg/
day
based
on
increased
incidence
of
lymphocytic
infiltration
of
the
renal
pelvis
and
chronic
nephropathy
in
males
and
decreased
body
weight
gain,
slight
increase
in
the
severity
of
hemosiderosis
of
the
spleen,
foci
of
cellular
alteration
in
liver
and
chronic
tubular
lesions
in
kidney
in
females.
No
evidence
of
carcinogenicity.
In
a
hepatic
cell
proliferation
study
in
mice,
the
NOAEL
was
16
(
male)
and
20
(
female)
mg/
kg/
day.
The
LOAEL
was
72
(
male)
and
87
(
female)
mg/
kg/
day
based
on
proliferative
activity
of
hepatocytes.
At
higher
dose
levels,
increases
in
absolute
and
relative
liver
weights,
speckled
liver,
heptocellular
glycogenesis/
fatty
change,
heptocellular
necrosis,
apoptosis
and
pigmentation
were
observed.
In
a
28
 
day
feeding
study
to
assess
replicative
DNA
synthesis
in
the
male
rat,
the
NOAEL
was
711
mg/
kg/
day.
The
LOAEL
was
not
established.
Immunohistochemical
staining
of
liver
sections
from
control
and
high
dose
animals
for
proliferating
cell
nuclear
antigen
gave
no
indication
for
a
treatment
related
increase
in
the
fraction
of
DNA
syntesizing
hepatocytes
in
Sphase
CGA
 
293343
did
not
stimulate
hepatocyte
cell
proliferation
in
male
rats.
In
a
special
study
to
assess
liver
biochemistry
in
the
mouse,
the
NOAEL
was
17
(
male)
and
92
(
female)
mg/
kg/
day.
The
LOAEL
was
74
(
male),
92
(
female)
mg/
kg/
day
based
on
marginal
to
slight
increases
in
absolute
and
relative
liver
weights,
a
slight
increase
in
the
microsomal
protein
content
of
the
livers,
moderate
increases
in
the
cytochrome
P450
content,
slight
to
moderate
increases
in
the
activity
of
several
microsomal
enzymes,
slight
to
moderate
induction
of
cytosolic
glutathionw
S­
transfersase
activity.
Treatment
did
not
affect
peroxisomal
fatty
acid
B­
oxidation.
6.
Animal
metabolism.
The
metabolism
of
thiamethoxam
in
rats
and
livestock
animals
is
adequately
understood.
The
residues
of
concern
have
been
determined
to
be
parent
thiamethoxam
and
its
metabolite
N­(
2­
chloro­
thiazol­
5­
ylmethyl)­
N'methyl­
Nnitro
guanidine.
7.
Metabolite
toxicology.
For
risk
assessment
purposes,
residues
of
the
metabolite
corrected
for
molecular
weight
are
considered
to
be
toxicologically
equivalent
to
parent
thiamethoxam.

C.
Aggregate
Exposure
1.
Dietary
exposure.
Permanent
tolerances
have
been
established
(
40
CFR
180.565)
for
the
combined
residues
of
the
insecticide
thiamethoxam,
3­[(
2­
chloro­
5­
thiazolyl)
methyl]
tetrahydro­
5­
methyl­
N­
nitro­
4H­
1,3,5­
oxadiazin­
4­
imine
and
its
metabolite
N­(
2­
chlorothiazol
5­
ylmethyl)­
N'­
methyl­
N­
nitroguanidine
in
or
on
a
variety
of
raw
agricultural
commodities
levels
ranging
from
0.02
parts
per
million
(
ppm)
to
1.5
ppm
(
including
barley,
canola,
corn,
cotton,
sorghum,
wheat,
cucurbit
vegetables,
fruiting
vegetables,
pome
fruits,
tuberous
and
corm
vegetables
and
livestock
commodities).
Pending
tolerances
include
coffee
(
imported),
grapes,
raisins,
grape
juice,
pecans,
sunflower
seed,
stone
fruits,
succulent
beans,
peppermint
and
spearmint
tops,
head
and
stem
brassica,
leafy
brassica
greens
and
leafy
vegetables.
Tier
III
chronic
and
Tier
I
acute
dietary
exposure
evaluations
were
made
using
the
Dietary
Exposure
Evaluation
Model
(
DEEMTM),
version
7.76
from
Exponent.
All
processing
factors
were
taken
from
the
EPA
assessment
of
August
28,
2000
(
DP
Barcode
D268606,
PC
Code
060109).
These
assessment
results
include
all
current
tolerances
and
the
proposed
tolerances
on
stone
fruit,
mint,
succulent
beans,
sunflower
seed,
pecans,
leafy
vegetables,
leafy
brassica
vegetables,
brassica
head
and
stem
vegetables
and
imported
coffee.
For
the
Tier
I
acute
assessment,
the
proposed
tolerance
residues
for
these
commodities
(
stone
fruit,
0.5
ppm;
mint,
4.0
ppm;
succulent
beans,
0.02
ppm;
sunflower
seed,
0.02
ppm;
pecans,
0.02
ppm;
leafy
vegetables,
2.0
ppm;
leafy
brassica
vegetables,
2.0
ppm;
brassica
head
and
stem
vegetables,
1.0
ppm;
and
imported
coffee,
0.05
ppm)
were
used
along
with
the
published
tolerances
for
all
other
commodities.
One
hundred
percent
of
crop
treated
was
assumed
for
all
commodities
in
the
acute
assessment.
In
the
chronic
assessments,
residue
values
for
secondary
animal
commodities,
pome
fruits,
ginger,
turmeric,
peppers,
potatoes,
wheat
and
barley
were
taken
from
the
EPA
assessment
of
August
28,
2000
which
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Notices
uses
average
field
trial
residue
data
with
c
LOQ
substitutions
for
all
nondetectable
residues.
In
addition,
a
residue
value
of
0.011
ppm
(
c
LOQ)
and
a
percent
crop
treated
value
of
6.6%
were
used
for
all
corn
commodities.
For
the
remaining
registered
and
the
proposed
commodities
listed
above,
the
following
residue
data
was
used
in
the
DEEMTM:
Cucurbit,
leafy
and
brassica
vegetables
and
tomatoes
­
average
field
trial
residues
from
soil­
only
application
residue
studies;
stone
fruits,
mint,
succulent
beans,
sunflower
seed,
and
coffee
­
average
field
trial
residue
data
with
c
LOQ
substitutions
for
nondetectable
residues;
and
pecans
­
the
proposed
tolerance.
In
regard
to
the
cucurbit
vegetables
and
tomatoes,
the
current
tolerances
are
based
upon
soil
and
foliar
uses;
however,
Syngenta
is
currently
limiting
the
use
of
thiamethoxam
in
these
crops
to
soil
only
applications
­
thus,
the
refinement
in
DEEMTM
inputs
described
above.
Likewise,
the
proposed
tolerances
on
leafy
vegetables,
leafy
brassica
vegetables
and
head
and
stem
brassica
vegetables
are
based
upon
soil
and
foliar
applications
of
thiamethoxam;
however,
Syngenta
is
currently
pursuing
only
the
soil
application
use
­
thus,
the
refinement
of
DEEM
inputs
described
above.
Syngenta
will
pursue
foliar
applications
for
these
crops
at
a
later
date;
therefore,
the
proposed
and
current
tolerances
on
these
crops
remain
based
upon
soil
and
foliar
applications.
All
consumption
data
for
these
assessments
was
taken
from
the
USDA's
Continuing
Survey
of
Food
Intake
by
Individuals
(
CSFII)
with
the
1994
 
96
consumption
data
base
and
the
supplemental
CSFII
children's
survey
(
1998)
consumption
data
base.
For
the
chronic
assessments,
the
following
percent
of
crop
treated
values
were
used
for
the
proposed
uses:
Coffee,
16.7%;
sunflower,
15%;
mint,
10%;
leaf
lettuce,
24.6%;
head
lettuce,
32%;
spinach
and
cress,
15.6%;
all
other
leafy
vegetables,
19.4%;
broccoli,
26.2%,
cabbage,
15.3%;
all
other
brassica
vegetables
17.2%;
beans,
20%;
stone
fruits,
15%;
and
pecans,
100%.
A
percent
crop
treated
value
of
5%
was
used
for
apples
and
a
value
of
6.6%
was
used
for
all
corn
commodities.
All
other
percent
of
crop
treated
values
were
taken
from
the
August
28,
2000
EPA
assessment.
i.
Food.
For
the
purposes
of
assessing
the
potential
dietary
exposure
under
the
proposed
tolerances,
Syngenta
Crop
Protection
has
estimated
aggregate
exposure
from
all
crops
for
which
tolerances
are
established
or
proposed.
The
Tier
I
acute
assessment
utilized
tolerance
values
and
100%
of
crop
treated
values.
The
Tier
III
chronic
assessments
utilized
the
residue
and
percent
of
crop
treated
values
described
above.
a.
Acute
exposure.
An
acute
reference
dose
of
0.10
mg/
kg
bwt/
day
for
all
population
subgroups
was
based
on
a
NOAEL
of
100
mg/
kg
bwt/
day
from
an
acute
neurotoxicity
study
in
rats
and
an
uncertainty
factor
of
100X
(
100X
for
combined
interspecies
and
intraspecies
variability).
An
additional
Food
Quality
Protection
Act
(
FQPA)
safety
factor
of
10X
was
applied
to
all
population
subgroups
due
to
the
absence
of
a
developmental
neurotoxicity
study.
For
the
purpose
of
aggregate
risk
assessment,
the
exposure
value
was
expressed
in
terms
of
margin
of
exposure
(
MOE).
The
MOE
was
calculated
by
dividing
the
NOAEL
by
the
exposure
for
each
population
subgroup.
In
addition,
exposure
was
expressed
as
a
percent
of
the
acute
reference
dose
(%
aRfD).
Acute
exposure
to
the
most
exposed
subpopulation
(
children
1
 
6
years
old)
resulted
in
a
MOE
of
6,452
(
15.5%
of
the
aRfD
of
0.10
mg/
kg/
bwt/
day)
at
the
95th
percentile
of
exposure.
Since
the
benchmark
MOE
for
this
assessment
was
1,000,
and
since
EPA
generally
has
no
concern
for
exposures
below
100%
of
the
aRfD,
Syngenta
believes
that
there
is
a
reasonable
certainty
that
no
harm
will
result
from
acute
dietary
(
food)
exposure
to
residues
arising
from
the
current
and
proposed
uses
for
thiamethoxam
chronic
exposure.
b.
Chronic
exposure.
The
chronic
reference
dose
(
cRfD)
for
thiamethoxam
is
0.0006
mg/
kg/
bwt/
day
for
all
population
subgroups
and
is
based
on
a
NOAEL
of
0.6
mg/
kg/
bwt/
day
from
a
two
generation
rat
reproduction
study.
An
uncertainty
factor
of
100X
(
for
combined
interspecies
and
intraspecies
variability)
and
an
additional
FQPA
safety
factor
of
10X
was
applied
due
to
evidence
of
increased
susceptibility
to
young
rats
following
prenatal/
postnatal
exposure.
Exposure
was
expressed
as
MOE
and
percent
of
the
reference
dose
(%
RfD).
Chronic
exposure
to
the
most
exposed
subpopulation
(
non­
nursing
infants)
resulted
in
a
MOE
of
11,538
(
8.6%
of
the
cRfD
of
0.0006
mg/
kg/
bw/
day).
Since
the
benchmark
MOE
for
this
assessment
was
1,000
and
since
EPA
generally
has
no
concern
for
exposures
below
100%
of
the
RfD,
Syngenta
believes
that
there
is
a
reasonable
certainty
that
no
harm
will
result
from
chronic
dietary
(
food)
exposure
to
residues
arising
from
the
current
and
proposed
uses
for
thiamethoxam.
c.
Lifetime
exposure.
The
Q*
value
for
thiamethoxam
is
0.0377
(
mg/
kg/
day)­
1
and
is
based
on
benign
and
malignant
heptocellular
tumors
in
mice
in
an
18
 
month
carcinogenicity
study.
Lifetime
exposure
to
the
U.
S.
population
resulted
in
a
lifetime
risk
of
8.17
x
10­
7
which
represents
81.7%
of
EPA's
lifetime
risk
limit
of
1.0
x
10­
6.
ii.
Drinking
water.
EPA
used
the
Pesticide
Root
Zone/
Exposure
Analysis
Modeling
System
(
PRZM/
EXAMS)
to
estimate
pesticide
concentrations
in
surface
water
and
SCI­
GROW,
which
predicts
pesticide
concentrations
in
ground
water.
None
of
these
models
include
consideration
of
the
impact
processing
(
mixing,
dilution,
or
treatment)
of
raw
water
for
distribution
as
drinking
water
would
likely
have
on
the
removal
of
pesticides
from
the
source
water.
The
primary
use
of
these
models
by
the
Agency
at
this
stage
is
to
provide
a
coarse
screen
for
sorting
out
pesticides
for
which
it
is
highly
unlikely
that
drinking
water
concentrations
would
ever
exceed
human
health
levels
of
concern.
Based
on
the
SCI­
GROW
and
PRZM/
EXAMS
models,
EPA
calculated
that
estimated
environmental
concentrations
of
thiamethoxam
at
the
highest
use
rate
(
0.125
lb
a.
i./
acre)
are
1.9
parts
per
billion
(
ppb)
for
acute
and
chronic
exposure
to
ground
water
and
11.4
ppb
and
0.77
ppb
for
acute
and
chronic
exposure,
respectively,
to
surface
water.
Based
on
field
and
laboratory
data
as
well
as
on
going
prospective
ground
water
monitoring
studies,
Syngenta
believes
that
the
potential
exposure
to
ground
water
is
much
lower
than
that
predicted
by
the
conservative
SCI­
GROW
model.
Preliminary
results
from
the
prospective
ground
water
monitoring
studies
have
indicated
no
detections
of
thiamethoxam
in
ground
water.
EPA
determined
estimated
environmental
concentrations
(
EECs)
are
used
for
comparison
to
Drinking
Water
Levels
of
Comparison
(
DWLOC).
a.
Acute
drinking
water
risk.
Acute
DWLOCs
were
calculated
based
on
an
acute
populated
adjusted
dose
(
aPAD)
of
0.1
mg/
kg/
day.
For
the
acute
assessment,
the
children
(
1
 
6
yrs)
subpopulation
generated
the
lowest
acute
DWLOC
of
approximately
845
ppb.
EPA
has
determined
that
the
surface
water
acute
EEC
is
11.4
ppb
and
the
ground
water
EEC
is
1.9
ppb.
Since
the
surface
water
value
is
greater
than
the
ground
water
value,
the
surface
water
value
will
be
used
for
comparison
purposes
and
will
protect
for
any
concerns
for
ground
water
concentrations.
Since
the
acute
DWLOC
of
845
ppb
is
considerably
higher
than
the
acute
EEC
of
11.4
ppb,
Syngenta
believes
that
EPA
should
not
have
a
concern
for
acute
risk
to
either
surface
or
ground
water.

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16046
Federal
Register
/
Vol.
68,
No.
63
/
Wednesday,
April
2,
2003
/
Notices
b.
Chronic
drinking
water
risk.
Chronic
DWLOCs
were
calculated
based
on
a
cPAD
of
0.0006
mg/
kg/
day.
For
the
chronic
assessment,
the
non­
nursing
infants
subpopulation
generated
the
lowest
chronic
DWLOC
of
approximately
5.5
ppb.
EPA
has
determined
that
the
surface
water
chronic
EEC
is
0.77
ppb
and
the
ground
water
EEC
is
1.9
ppb.
Since
the
ground
water
value
is
greater
than
the
surface
water
value,
the
ground
water
value
will
be
used
for
comparison
purposes
and
will
protect
for
any
concerns
for
surface
water
concentrations.
Since
the
chronic
DWLOC
of
5.5
ppb
is
higher
than
the
chronic
EEC
of
1.9
ppb,
Syngenta
believes
that
EPA
should
not
have
a
concern
for
chronic
risk
to
either
surface
or
ground
water.
c.
Lifetime
drinking
water
risk.
Based
on
currently
registered
and
proposed
uses
for
thiamethoxam,
Syngenta
has
determined
a
DWLOC
of
2.0
ppb.
At
the
currently
registered
maximum
use
rate
of
0.125
lbs.
a.
i.
per
acre
per
growing
season,
EPA
has
used
the
SCI­
GROW
model
to
predict
a
ground
water
EEC
of
1.9
ppb.
Thus,
the
ground
water
EEC
is
below
the
lifetime
DWLOC
for
the
general
population.
The
Agency
used
a
screening
level
model
designed
to
estimate
pesticide
concentrations
in
shallow
ground
water.
A
number
of
factors
demonstrate
that
the
actual
lifetime
exposure
through
drinking
water
will
be
less
than
the
lifetime
DWLOC.
These
reasons
are
as
follows:
 
Thiamethoxam
is
a
systemic
pesticide.
EPA's
Tier
I
ground
water
model
assumes
that
all
of
the
product
that
is
applied
to
the
crop
is
available
for
run
off.
Syngenta
has
submitted
data
to
show
that
a
percentage
(
15
 
25%)
of
the
product
is
absorbed
by
the
plant,
resulting
in
that
much
less
product
available
to
leach
into
ground
water.
Although,
data
submitted
is
on
only
two
crops
(
beans
and
cucumbers),
it
is
likely
that
the
total
amount
of
thiamethoxam
available
for
ground
water
leaching
is
less
than
the
amount
EPA
uses
as
a
model
input.
 
Although,
the
Agency
model
is
based
on
aerobic
soil
half
lives,
EPA's
lifetime
risk
assessment
is
for
lifetime
exposure.
Data
indicate
the
anaerobic
aquatic
half­
life
for
thiamethoxam
is
shorter
than
the
aerobic
soil
half­
life
and
longer
than
the
aerobic
aquatic
halflife
Although,
EPA
is
unable
to
predict,
with
a
high
degree
of
certainty,
what
happens
to
thiamethoxam
ground
water
over
time,
this
does
provide
some
support
for
the
expectation
that
concentrations
in
ground
water
will
decline
between
annual
applications.
 
Shallow
ground
water
modeling
is
not
the
perfect
model
for
representing
all
drinking
water
from
ground
water
sources.
It
is
likely
to
be
an
over
estimate
of
most
drinking
water
concentrations,
which
tend
to
originate
from
deeper
sources.
EPA's
experience
is
that
the
model
is
reasonably
accurate
for
shallow
drinking
water,
but
it
is
less
accurate
for
estimating
concentrations
in
drinking
water
from
deeper
sources.
 
The
Agency
has
established
conditions
of
registration
for
the
previous
uses
that
include
two
prospective
ground
water
studies
and
a
retrospective
monitoring
study,
so
that
the
reasonable
certainty
of
no
harm
finding
will
be
sustained.
Preliminary
results
have
indicated
no
detections
of
thiamethoxam
in
ground
water.
 
The
dietary
food
risk
is
based
on
residue
data
derived
from
the
average
of
field
trials,
which
were
performed
at
a
higher
application
rate
than
what
was
accepted
by
EPA.
It
is
not
unusual
in
the
Agency's
experience
for
field
trial
data
to
be
an
order
of
magnitude
above
actual
monitoring.
Since
thiamethoxam
has
only
recently
been
registered,
actual
monitoring
data
are
not
yet
available.
It
is
likely
that
the
actual
risk
contribution
from
food
will
be
much
lower
than
current
data
indicate,
which
would
result
in
a
larger
lifetime
DWLOC.
Syngenta
expects
that
this
refined
lifetime
DWLOC
would
be
larger
than
the
EECs
for
the
proposed
uses.
Based
on
the
previous
points,
Syngenta
does
not
expect
that
the
general
population
would
be
exposed
to
levels
exceeding
the
lifetime
DWLOC.
2.
Non­
dietary
exposure.
Thiamethoxam
is
not
currently
registered
for
use
on
any
sites
that
would
result
in
residential
exposure.

D.
Cumulative
Effects
The
potential
for
cumulative
effects
of
thiamethoxam
and
other
substances
that
have
a
common
mechanism
of
toxicity
has
also
been
considered.
Thiamethoxam
belongs
to
a
new
pesticide
chemical
class
known
as
the
neonicotinoids.
There
is
no
reliable
information
to
indicate
that
toxic
effects
produced
by
thiamethoxam
would
be
cumulative
with
those
of
any
other
chemical
including
another
pesticide.
Therefore,
Syngenta
believes
it
is
appropriate
to
consider
only
the
potential
risks
of
thiamethoxam
in
an
aggregate
risk
assessment.

E.
Safety
Determination
Syngenta
concludes,
as
described
above,
that
there
is
reasonable
certainty
that
no
harm
to
the
U.
S.
population
will
result
from
aggregate
acute
or
chronic
dietary
exposure
to
thiamethoxam
residues
including
the
proposed
commodities.
F.
International
Tolerances
There
are
no
codex
MRLs
established
for
residues
of
thiamethoxam.
[
FR
Doc.
03
 
7803
Filed
4
 
1
 
03;
8:
45
am]

BILLING
CODE
6560
 
50
 
S
ENVIRONMENTAL
PROTECTION
AGENCY
[
OPP
 
2003
 
0102;
FRL
 
7299
 
6]

Fludioxonil;
Notice
of
Filing
Pesticide
Petitions
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
 
0102,
must
be
received
on
or
before
May
2,
2003.
ADDRESSES:
Comments
may
be
submitted
electronically,
by
mail,
or
through
hand
delivery/
courier.
Follow
the
detailed
instructions
as
provided
in
Unit
I.
C.
of
the
SUPPLEMENTARY
INFORMATION.

FOR
FURTHER
INFORMATION
CONTACT:
Sidney
Jackson,
Registration
Division
(
7505C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001;
telephone
number:
(
703)
305
 
7610;
e­
mail
address:
jackson.
sidney@
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.
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.
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
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