Document ID: EPA-HQ-OPP-2003-0261-0001
Agency: epa
Document Type: Notice
Title: Penoxsulam; Notice of Filing a Pesticide Petition To Establish a Tolerance for a Certain Pesticide Chemical in or on Food
Posted Date: 2003-08-06T04:00Z

46609
Federal
Register
/
Vol.
68,
No.
151
/
Wednesday,
August
6,
2003
/
Notices
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
registration
activity.
7.
Make
sure
to
submit
your
comments
by
the
deadline
in
this
notice.
8.
To
ensure
proper
receipt
by
EPA,
be
sure
to
identify
the
docket
ID
number
assigned
to
this
action
in
the
subject
line
on
the
first
page
of
your
response.
You
may
also
provide
the
name,
date,
and
Federal
Register
citation.

II.
Registration
Applications
EPA
received
applications
as
follows
to
register
pesticide
products
containing
active
ingredients
not
included
in
any
previously
registered
products
pursuant
to
the
provision
of
section
3(
c)(
4)
of
FIFRA.
Notice
of
receipt
of
these
applications
does
not
imply
a
decision
by
the
Agency
on
the
applications.

Products
Containing
Active
Ingredients
Not
Included
in
Any
Previously
Registered
Products
1.
File
symbol:
73512
 
E.
Applicant:
Interregional
Research
Project
4
(
IR­
4),
Rutgers
University,
Technology
Center
of
New
Jersey,
681
U.
S.
Highway
1
South,
North
Brunswick,
NJ
08902
 
3390
on
behalf
of
Morse
Enterprises
Limited,
Inc.,
Brickell
East,
Floor
Ten,
151
South
East
15
Road,
Miami,
FL
33129.
Product
name:
Yeast
Hydrolysate
Liquid.
Active
ingredient:
Yeast
extract
hydrolysate
from
Saccharomyces
cerevisiae
at
2.5%.
Proposed
classification/
Use:
None.
Manufacturing
use
product
for
management
of
plant
diseases.
2.
File
symbol:
73512
 
R.
Applicant:
Interregional
Research
Project
4
(
IR
 
4).
Product
name:
KeyPlex
350.
Active
ingredient:
Yeast
Extract
hydrolysate
from
Saccharomyces
cerevisiae
at
0.063%.
Proposed
classification/
Use:
None.
For
use
in
management
of
plant
diseases.

List
of
Subjects
Environmental
protection,
Pesticides
and
pest.

Dated:
July
28,
2003.
Janet
L.
Andersen,
Director,
Biopesticides
and
Pollution
Prevention
Division,
Office
of
Pesticide
Programs.

[
FR
Doc.
03
 
19917
Filed
8
 
5
 
03;
8:
45
am]

BILLING
CODE
6560
 
50
 
S
ENVIRONMENTAL
PROTECTION
AGENCY
[
OPP
 
2003
 
0261;
FRL
 
7320
 
4]

Penoxsulam;
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
 
0261,
must
be
received
on
or
before
September
5,
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:
Joanne
Miller,
Registration
Division
(
7505C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001;
telephone
number:
(
703)
305
 
6224;
e­
mail
address:
miller.
joanne@
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
113)
 
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
identification
(
ID)
number
OPP
 
2003
 
0261.
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
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19:
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Federal
Register
/
Vol.
68,
No.
151
/
Wednesday,
August
6,
2003
/
Notices
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
EPA's
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
in
paper,
will
be
made
available
for
public
viewing
in
EPA's
electronic
public
docket
as
EPA
receives
them
and
without
change,
unless
the
comment
contains
copyrighted
material,
CBI,
or
other
information
whose
disclosure
is
restricted
by
statute.
When
EPA
identifies
a
comment
containing
copyrighted
material,
EPA
will
provide
a
reference
to
that
material
in
the
version
of
the
comment
that
is
placed
in
EPA's
electronic
public
docket.
The
entire
printed
comment,
including
the
copyrighted
material,
will
be
available
in
the
public
docket.
Public
comments
submitted
on
computer
disks
that
are
mailed
or
delivered
to
the
docket
will
be
transferred
to
EPA's
electronic
public
docket.
Public
comments
that
are
mailed
or
delivered
to
the
docket
will
be
scanned
and
placed
in
EPA's
electronic
public
docket.
Where
practical,
physical
objects
will
be
photographed,
and
the
photograph
will
be
placed
in
EPA's
electronic
public
docket
along
with
a
brief
description
written
by
the
docket
staff.

C.
How
and
To
Whom
Do
I
Submit
Comments?
You
may
submit
comments
electronically,
by
mail,
or
through
hand
delivery/
courier.
To
ensure
proper
receipt
by
EPA,
identify
the
appropriate
docket
ID
number
in
the
subject
line
on
the
first
page
of
your
comment.
Please
ensure
that
your
comments
are
submitted
within
the
specified
comment
period.
Comments
received
after
the
close
of
the
comment
period
will
be
marked
``
late.''
EPA
is
not
required
to
consider
these
late
comments.
If
you
wish
to
submit
CBI
or
information
that
is
otherwise
protected
by
statute,
please
follow
the
instructions
in
Unit
I.
D.
Do
not
use
EPA
Dockets
or
e­
mail
to
submit
CBI
or
information
protected
by
statute.
1.
Electronically.
If
you
submit
an
electronic
comment
as
prescribed
in
this
unit,
EPA
recommends
that
you
include
your
name,
mailing
address,
and
an
email
address
or
other
contact
information
in
the
body
of
your
comment.
Also
include
this
contact
information
on
the
outside
of
any
disk
or
CD
ROM
you
submit,
and
in
any
cover
letter
accompanying
the
disk
or
CD
ROM.
This
ensures
that
you
can
be
identified
as
the
submitter
of
the
comment
and
allows
EPA
to
contact
you
in
case
EPA
cannot
read
your
comment
due
to
technical
difficulties
or
needs
further
information
on
the
substance
of
your
comment.
EPA's
policy
is
that
EPA
will
not
edit
your
comment,
and
any
identifying
or
contact
information
provided
in
the
body
of
a
comment
will
be
included
as
part
of
the
comment
that
is
placed
in
the
official
public
docket,
and
made
available
in
EPA's
electronic
public
docket.
If
EPA
cannot
read
your
comment
due
to
technical
difficulties
and
cannot
contact
you
for
clarification,
EPA
may
not
be
able
to
consider
your
comment.
i.
EPA
Dockets.
Your
use
of
EPA's
electronic
public
docket
to
submit
comments
to
EPA
electronically
is
EPA's
preferred
method
for
receiving
comments.
Go
directly
to
EPA
Dockets
at
http://
www.
epa.
gov/
edocket,
and
follow
the
online
instructions
for
submitting
comments.
Once
in
the
system,
select
``
search,''
and
then
key
in
docket
ID
number
OPP
 
2003
 
0261.
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
 
0261.
In
contrast
to
EPA's
electronic
public
docket,
EPA's
e­
mail
system
is
not
an
``
anonymous
access''
system.
If
you
send
an
e­
mail
comment
directly
to
the
docket
without
going
through
EPA's
electronic
public
docket,
EPA's
e­
mail
system
automatically
captures
your
e­
mail
address.
E­
mail
addresses
that
are
automatically
captured
by
EPA's
e­
mail
system
are
included
as
part
of
the
comment
that
is
placed
in
the
official
public
docket,
and
made
available
in
EPA's
electronic
public
docket.
iii.
Disk
or
CD
ROM.
You
may
submit
comments
on
a
disk
or
CD
ROM
that
you
mail
to
the
mailing
address
identified
in
Unit
I.
C.
2.
These
electronic
submissions
will
be
accepted
in
WordPerfect
or
ASCII
file
format.
Avoid
the
use
of
special
characters
and
any
form
of
encryption.
2.
By
mail.
Send
your
comments
to:
Public
Information
and
Records
Integrity
Branch
(
PIRIB)
(
7502C),
Office
of
Pesticide
Programs
(
OPP),
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001,
Attention:
Docket
ID
Number
OPP
 
2003
 
0261.
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
 
0261.
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
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Federal
Register
/
Vol.
68,
No.
151
/
Wednesday,
August
6,
2003
/
Notices
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
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
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:
July
28,
2003.
Debra
Edwards,
Director,
Registration
Division,
Office
of
Pesticide
Programs.

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

Dow
AgroSciences
LLC
PP
3F6542
EPA
has
received
a
pesticide
petition
(
3F6542)
from
Dow
AgroSciences
LLC,
9330
Zionsville
Road,
Indianapolis,
IN
46268
proposing,
pursuant
to
section
408(
d)
of
the
FFDCA,
21
U.
S.
C.
346a(
d),
to
amend
40
CFR
part
180,
by
establishing
a
tolerance
for
residues
of
2­(
2,2­
difluoroethoxy)­
6­
trifluoromethyl­
N­(
5,8­
dimethoxy
[
1,2,4]
triazolo­
1,5c
pyrimidin­
2­
yl)
benzenesulfonamide,
(
penoxsulam,
DE
 
638)
in
or
on
the
raw
agricultural
commodity
rice
raw
agricultural
commodities
(
RACS)
and
rice
processed
products
at
0.01
part
per
million
(
ppm)
for
rice
grain,
0.05
ppm
for
rice
straw,
0.01
ppm
for
rice
hull,
0.01
ppm
for
rice
bran,
and
0.01
ppm
for
polished
rice.
EPA
has
determined
that
the
petition
contains
data
or
information
regarding
the
elements
set
forth
in
section
408(
d)(
2)
of
the
FFDCA;
however,
EPA
has
not
fully
evaluated
the
sufficiency
of
the
submitted
data
at
this
time
or
whether
the
data
support
granting
of
the
petition.
Additional
data
may
be
needed
before
EPA
rules
on
the
petition.

A.
Residue
Chemistry
1.
Plant
metabolism.
The
nature
of
residue
study
in
rice,
treated
with
14C
 
labeled
DE
 
638
(
2
 
position
on
the
triazolopyrimidine
ring
or
uniformly
labeled
in
the
phenyl
ring)
at
100
grams
(
g/
ha),
demonstrated
that
no
significant
residues
(
0.003
 
0.022
ppm)
were
found
in
mature
straw
and
grain.
The
residues
were
fractionated
by
reversed­
phase
high
performance
liquid
chromotography
(
HPLC)
and
consisted
of
DE
 
638,
5
 
OH
DE
 
638
(
identified
by
retention
time),
and
two
unidentified
peaks.
Each
component
was
<
0.01
µ
g/
g
(
DE
 
638
equivalents).
Based
on
the
plant
metabolism
studies,
the
tolerance
expression
is
the
parent,
penoxulam.
Metabolism
studies
in
livestock
animals
with
14C
 
labeled
DE
 
638
(
2
 
position
on
the
triazolopyrimidine
ring
or
uniformly
labeled
in
the
phenyl
ring)
at
a
concentration
equivalent
to
about
10
ppm
in
the
diet
indicated
that
approximately
99%
of
the
administered
dose
was
eliminated
in
the
excreta.
The
low
levels
of
residues
(
0.002
 
0.07
ppm)
in
fat
and
edible
tissues,
milk
or
eggs
demonstrate
that
residues
due
to
DE
 
638
would
not
accumulate
in
the
animals.
Additionally,
the
dose
levels
in
these
studies
are
about
200
to
1,000
times
higher
than
the
theoretical
maximum
exposure
in
the
animal
diet
of
rice
commodities
treated
with
DE
 
638,
therefore,
livestock
feeding
studies
are
not
considered
necessary.
A
bioconcentration
study
on
crayfish
was
conducted
to
determine
the
residues
in
edible
tissues
and
estimate
the
bioconcentration
factor.
Crayfish
(
Procambarus
clarkii)
were
exposed
for
14
days
to
14C­
DE
 
638
under
flowthrough
conditions
at
an
average
exposure
concentration
of
494
µ
g/
L
(
Cw),
equivalent
to
approximately
10x
the
initial
estimated
environmental
concentration
(
EEC)
based
on
the
maximum
application
rate
of
50
grams
active
ingredient/
ha
and
one
hectare
rice
paddy
with
10
centimeters
(
cm)
depth
water.
Plateau
of
residues
in
crayfish
occurred
within
5
days
following
initiation
of
exposure
with
residues
in
edible
tissues
reaching
an
average
steady­
state
concentration
of
0.009
µ
g/
g
(
Cf).
The
bioconcentration
factor
(
Cf/
Cw)
was
estimated
to
be
<
0.1
milligram
per
liter/
gram
(
mg/
L/
g),
indicating
that
penoxsulam
has
very
low
potential
to
bioconcentrate
in
edible
tissues
of
crayfish.
Based
on
the
very
low
residues
of
<
0.01
µ
g/
g
(
method
limit
of
detection
(
LOD)
is
0.003
µ
g/
g)
in
edible
tissues
of
crayfish
exposed
to
10x
the
peak
EEC,
no
tolerance
in
crayfish
is
required.
2.
Analytical
method.
An
analytical
method
has
been
developed
and
validated
to
determine
the
residues
of
penoxsulam
in
rice
grain,
straw,
and
processed
products.
The
method
was
based
on
liquid
chromatography
with
positive
ion
electrospray
tandem
mass
spectrometry
molecular
size
(
LC/
MS/
MS)
with
LOD
of
0.002
µ
g/
g
and
limit
of
quantitation
(
LOQ)
of
0.01
µ
g/
g.
The
method
has
been
successfully
validated
by
an
independent
laboratory.

B.
Toxicological
Profile
1.
Acute
toxicity.
The
acute
toxicity
of
penoxsulam
is
considered
low.
The
acute
oral
and
dermal
LD50s
were
greater
than
5,000
milligrams/
kilogram
(
mg/
kg),
while
the
acute
inhalation
LC50
was
greater
than
the
highest
attainable
aerosol
concentration
(
3.50
mg/
L).
Only
very
slight,
transient
dermal
irritation
was
seen,
and
mild
eye
irritation
was
noted.
Penoxsulam
was
negative
for
skin
sensitization
in
a
Magnussen
and
Kligman
maximization
test
involving
intradermal
injection
of
penoxsulam
with
an
adjuvant.

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Federal
Register
/
Vol.
68,
No.
151
/
Wednesday,
August
6,
2003
/
Notices
2.
Genotoxicity.
Penoxsulam
was
negative
for
genotoxicity
when
tested
in
in
vitro
and
in
vivo
systems.
3.
Reproductive
and
developmental
toxicity.
Penoxsulam
did
not
have
any
effect
on
reproductive
parameters
at
dose
levels
that
induced
treatmentrelated
effects
in
parental
rats.
At
the
highest
dosage
tested
(
HDT)
(
300
mg/
kg/
day),
body
weights
and
weight
gains
in
both
males
and
females
were
depressed,
liver
and/
or
kidney
weights
were
increased,
and
histologic
changes
were
noted
in
the
liver
(
males)
and
kidneys
(
females).
At
100
mg/
kg/
day,
increased
liver
weights
were
recorded
in
males,
with
no
histologic
correlate,
and
histologic
changes
noted
in
the
kidneys
of
females.
Transient
decreases
in
pup
body
weights
were
seen
at
the
HDT,
but
dietary
concentrations
were
targeted
for
adults
and
consumption
of
treated
diets
by
the
pups
resulted
in
dose
levels
to
the
pups
approximately
3
 
fold
higher
than
in
adults.
A
teratogenic
potential
was
not
demonstrated
for
penoxsulam
in
either
rats
or
rabbits.
4.
Subchronic
toxicity.
Dietary
exposure
to
penoxsulam
identified
the
liver
and/
or
urinary
tract
(
kidneys
and
bladder)
as
target
organs
in
rats,
mice,
and
dogs
following
a
4
 
week
and
13
 
week
administration.
Effects
on
the
liver
were
reflected
in
increased
liver
weights
and
hepatocellular
hypertrophy,
but
these
effects
were
not
associated
with
increases
in
mixed
function
oxidase
(
MFO)
enzyme
activity.
Effects
noted
in
the
kidneys
included
crystal
deposition,
most
likely
from
precipitation
of
penoxsulam
from
the
urine,
with
resultant
irritation,
inflammation,
and
hyperplasia
of
renal
pelvic
transitional
epithelium.
Other
than
the
crystal
deposition
in
the
kidneys,
all
effects
following
subchronic
exposure
to
rats
appeared
to
be
reversible.
Very
high
doses
were
associated
with
significant
decreases
in
body
weight,
weight
gain,
and
feed
consumption.
5.
Chronic
toxicity.
Chronic
exposure
in
the
dog
indicated
that
the
renal
effects
were
not
exacerbated
with
longterm
exposure.
Following
long­
term
exposure
in
rats,
the
kidneys
and
urinary
bladder
were
the
primary
target
organs.
Histologic
changes
seen
at
the
end
of
2
years
of
exposure
consisted
of
inflammation
and
hyperplasia
of
the
renal
pelvic
transitional
epithelium,
crystal
deposition
in
the
kidneys
and
urinary
bladder,
and
hyperplasia
of
the
mucosa
of
the
urinary
bladder.
In
the
mouse,
the
liver
was
the
primary
target
organ,
and
histologic
changes
consisted
of
hepatocellular
hypertrophy.
There
were
no
treatment­
related
increases
in
tumors
in
either
rats
or
mice.
The
incidence
of
mononuclear
cell
leukemia
(
Fischer
rat
leukemia)
was
increased
in
all
groups
of
treated
male
rats
compared
to
the
concurrent
controls.
However,
the
incidences
in
the
treated
groups
were
identical
across
a
50
 
fold
increase
in
dosage,
and
well
within
the
range
of
control
values
reported
in
the
literature.
Using
the
Guidelines
for
Carcinogen
Risk
Assessment
published
September
24,
1986
(
51
FR
33992),
it
is
proposed
that
penoxsulam
be
classified
as
Group
E
for
carcinogenicity
(
no
evidence
of
carcinogenicity)
based
on
the
results
of
carcinogenicity
studies
in
two
species.
Dow
AgroSciences
LLC
believes
there
was
no
evidence
of
carcinogenicity
in
an
18
 
month
mouse
feeding
study
and
a
24
 
month
rat
feeding
study
at
all
dosages
tested.
6.
Animal
metabolism.
Orally
administered
penoxsulam
is
rapidly
absorbed,
excreted
and
extensively
metabolized
in
both
male
and
female
rats,
thus,
indicating
that
penoxsulam
is
not
expected
to
accumulate
in
biological
systems.
The
majority
of
the
residue
was
associated
with
the
parent,
penoxsulam.
Several
metabolites
were
also
observed
but
the
vast
majority
were
<
1%
of
the
administered
dose.
The
major
route
of
metabolism
involves
O­
demethylation,
producing
the
OH­
Penoxsulam
metabolite
followed
by
conjugation.
7.
Metabolite
toxicology.
A
metabolism
study
with
penoxsulam
in
rice
revealed
the
presence
of
the
parent,
a
desmethylation
metabolite
(
5­
OHpenoxsulam
and
two
other
polar
metabolites,
which
may
represent
conjugates
of
the
desmethylated
metabolite.
The
5­
OH­
penoxsulam
metabolite
and
its
glucuronide
and
glutathione
conjugates
have
also
been
identified
in
the
plasma
and
liver
of
rats;
therefore,
plant
metabolites
are
considered
of
little
toxicological
concern.
8.
Neurotoxicity.
Penoxsulam
has
been
shown
to
have
no
neurotoxicologic
potential
based
on
acute
and
subchronic
studies.
9.
Endocrine
disruption.
Penoxsulam
did
not
have
any
effects
on
endocrine
organs
or
tissues
in
mice,
rats
or
dogs
in
any
of
the
studies
conducted.
There
were
no
indications
of
effects
on
fetal
development
in
either
rats
or
rabbits,
or
on
reproductive
performance
in
rats.
Based
on
the
lack
of
any
effects
on
the
endocrine
system,
penoxsulam
is
not
considered
an
endocrine
disrupter.

C.
Aggregate
Exposure
Dietary
exposure.
Based
on
the
rapid
degradation
of
penoxsulam,
no
surface
water
or
ground
water
contamination
is
expected.
This
agrees
with
EPA
Tier
I
modeling
carried
out
on
penoxsulam.
Therefore,
drinking
water
will
not
be
a
significant
route
of
exposure.
Dietary
exposure
is
very
low
as
previously
mentioned.
In
addition,
a
rotational
crop
study
showed
no
carryover
of
penoxsulam
related
residues
in
any
representative
test
crop.
There
are
no
residential
uses
for
this
compound.
As
a
result,
the
only
potential
for
exposure
is
dietary,
which
is
acceptable.
Therefore,
aggregation
of
exposures
is
not
necessary.

D.
Cumulative
Effects
Currently,
no
methodologies
are
available
to
resolve
the
complex
scientific
issues
concerning
common
mechanism
of
toxicity
and
cumulative
exposure
and
risk.
EPA
has
begun
a
pilot
process
to
study
this
issue
further
through
the
examination
of
particular
classes
of
pesticides.
Thus,
Dow
AgroSciences
LLC
believes
it
is
appropriate
to
consider
only
the
potential
risks
of
penoxsulam
in
its
exposure
assessment.

E.
Safety
Determination
1.
U.
S.
population.
Using
the
conservative
exposure
assumptions
described
above,
and
based
on
the
completeness
and
reliability
of
the
toxicity
data,
the
aggregate
exposure
to
penoxsulam,
as
determined
under
the
guidance
of
the
FQPA,
will
utilize
no
more
than
0.1%
of
the
RfD
from
the
dietary
exposure
for
all
subgroups
of
the
U.
S.
population.
Generally
and
under
the
Food
Quality
Protection
Act
(
FQPA),
EPA
has
no
concern
for
exposures
below
100%
of
the
reference
dose
(
RfD)
because
the
RfD
represents
the
level
at
or
below
which
daily
dietary
exposure
over
a
lifetime
will
not
pose
appreciable
risks
to
human
health.
Additionally,
the
calculated
drinking
water
levels
of
concern
(
DWLOC)
was
substantially
higher
than
the
potential
penoxsulam
concentration
in
water.
Therefore,
there
is
a
reasonable
certainty
that
no
harm
will
result
to
the
general
U.
S.
population
from
aggregate
exposure
to
penoxsulam
residues
from
proposed
use.
2.
Infants
and
children.
In
assessing
the
potential
for
additional
sensitivity
of
infants
and
children
to
residues
of
penoxsulam,
data
from
developmental
toxicity
studies
in
rats
and
rabbits
and
a
multi­
generation
reproduction
study
in
the
rat
are
considered.
The
developmental
toxicity
studies
are
designed
to
evaluate
adverse
effects
on
the
developing
organism
resulting
from
pesticide
exposure
during
prenatal
development.
Reproduction
studies
provide
information
relating
to
effects
from
exposure
of
both
parents
to
the
pesticide
on
the
reproductive
capability
and
potential
systemic
toxicity
of
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Federal
Register
/
Vol.
68,
No.
151
/
Wednesday,
August
6,
2003
/
Notices
mating
animals
and
on
various
parameters
associated
with
the
well
being
of
offspring.
FFDCA
section
408
provides
that
EPA
may
apply
an
additional
safety
factor
(
SF)
for
infants
and
children
in
the
case
of
threshold
effects
to
account
for
prenatal
and
postnatal
toxicity
and
the
completeness
of
the
data
base.
Based
on
the
current
toxicological
data
requirements,
the
data
base
for
penoxsulam
relative
to
prenatal
and
postnatal
effects
for
children
is
complete.
Overall,
penoxsulam
had
no
effect
on
reproduction
or
embryo­
fetal
development
at
any
dosage
tested.
No
quantitative
or
qualitative
susceptibility
was
seen
following
prenatal
and
postnatal
exposures.
In
a
rabbit
developmental
toxicity
study,
effects
on
in­
utero
survival
were
observed
only
at
a
dose
level
where
clear
maternal
toxicity
was
seen.
In
a
2
 
generation
reproductive
toxicity
study
in
rats,
no
effects
on
reproductive
performance
were
observed
and
effects
on
neonatal
growth
were
seen
only
at
a
dose
level
where
parental
toxicity
was
seen.
In
addition,
the
no
observed
adverse
effect
level
(
NOAEL)
in
the
chronic
rat
study
(
5
mg/
kg/
day),
used
to
calculate
the
chronic
RfD
(
0.05
mg/
kg/
day),
is
already
lower
than
the
acute
NOAEL
from
the
rabbit
developmental
study
(
25
mg/
kg/
day).
Therefore,
an
additional
FQPA
uncertainty
factor
(
UF)
is
not
needed
and
the
RfD
at
0.05
mg/
kg/
day
is
appropriate
for
assessing
risk
to
infants
and
children.
Using
the
conservative
exposure
assumptions
previously
described,
the
percent
RfD
utilized
by
the
potential
exposure
to
residues
of
penoxsulam
on
rice
is
<
0.1%
for
nonnursing
infants,
the
population
subgroup
predicted
to
be
potentially
the
most
highly
exposed.
Risk
for
developmental
toxicity
from
acute
exposure
to
penoxsulam
was
evaluated
for
pregnant
females
(
13+
years
old).
The
high­
end
margin
of
exposure
value
of
>
300,000
(
0.03%
of
acute
RfD)
is
well
above
the
acceptable
100.
Therefore,
based
on
the
completeness
and
reliability
of
the
toxicity
data
and
the
conservative
exposure
assessment,
Dow
AgroSciences
LLC
concludes
with
reasonable
certainty
that
no
harm
will
result
to
infants
and
children,
females
13+
years
old
and
the
prenatal
development
of
infants
from
the
aggregate
exposure
to
penoxsulam
residues.

F.
International
Tolerances
There
are
no
Codex
maximum
residue
levels
established
for
residues
of
penoxsulam
on/
in
rice
and
rice.

[
FR
Doc.
03
 
20015
Filed
8
 
5
 
03;
8:
45
BILLING
CODE
6560
 
50
 
S
ENVIRONMENTAL
PROTECTION
AGENCY
[
OPP
 
2003
 
0152;
FRL
 
7316
 
8]

Yeast
Extract
Hydrolysate
from
Saccharomyces
Cerevisiae;
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
indentification
(
ID)
number
OPP
 
2003
 
0152,
must
be
received
on
or
before
September
5,
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:
Diana
M.
Horne,
Biopesticides
and
Pollution
Prevention
Division
(
7511C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001;
telephone
number:
(
703)
308
 
8367;
e­
mail
address:
horne.
diana@
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
 
0152.
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
EPA's
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
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