Document ID: EPA-HQ-OPP-2003-0031-0001
Agency: epa
Document Type: Notice
Title: Spiroxamine; Notice of Filing Pesticide Petitions to Establish Tolerances for a Certain Pesticide Chemical in or on Food
Posted Date: 2003-03-07T05:00Z

11088
Federal
Register
/
Vol.
68,
No.
45
/
Friday,
March
7,
2003
/
Notices
DFO.
Members
of
the
public
are
requested
to
call
the
DFO
at
the
number
listed
below
if
planning
to
attend
so
that
arrangements
can
be
made
to
comfortably
accommodate
attendees
as
much
as
possible,
and
to
facilitate
security
clearance
to
the
meeting.
Seating
will
be
on
a
first
come,
first
served
basis.
DATES:
The
Local
Government
Advisory
Committee
plenary
session
will
begin
at
8:
30
a.
m.
Thursday,
March
27
and
conclude
at
3
p.
m.
on
March
28.
ADDRESSES:
The
meetings
will
be
held
at
the
EPA's
Region
4
Office
located
at
61
Forsyth
Street,
SW.,
(
Sam
Nunn
Federal
Center),
Atlanta,
GA
30303.
Plenary
sessions
will
be
held
in
the
Atlanta/
Augusta
Rooms(
3B90)
in
the
Third
floor
Bridge
Conference
center.
Additional
information
can
be
obtained
by
writing
the
DFO
at
1200
Pennsylvania
Avenue,
NW.,
(
1306A),
Washington,
DC
20460.
FOR
FURTHER
INFORMATION
CONTACT:
The
DFO
for
the
Local
Government
Advisory
Committee
(
LGAC)
is
Paul
Guthrie
(
202)
564
 
3649.

Dated:
February
25,
2003.
Paul
N.
Guthrie,
Designated
Federal
Officer,
Local
Government
Advisory
Committee.
[
FR
Doc.
03
 
5473
Filed
3
 
6
 
03;
8:
45
am]

BILLING
CODE
6560
 
50
 
P
ENVIRONMENTAL
PROTECTION
AGENCY
[
OPP
 
2003
 
0031;
FRL
 
7290
 
5]

Spiroxamine;
Notice
of
Filing
Pesticide
Petitions
to
Establish
Tolerances
for
a
Certain
Pesticide
Chemical
in
or
on
Food
AGENCY:
Environmental
Protection
Agency
(
EPA).
ACTION:
Notice.

SUMMARY:
This
notice
announces
the
initial
filing
of
pesticide
petitions
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
 
0031,
must
be
received
on
or
before
April
7,
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:
Mary
Waller,
Registration
Division
(
7505C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001;
telephone
number:
(
703)
308
 
9354;
e­
mail
address:
waller.
mary@
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
 
0031.
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
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Federal
Register
/
Vol.
68,
No.
45
/
Friday,
March
7,
2003
/
Notices
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
 
0031.
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
 
0031.
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
 
0031.
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
 
0031.
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
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.

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Federal
Register
/
Vol.
68,
No.
45
/
Friday,
March
7,
2003
/
Notices
Dated:
February
6,
2003.
Debra
Edwards,
Acting
Director,
Registration
Division,
Office
of
Pesticide
Programs.

Summary
of
Petitions
The
petitioners
summaries
of
the
pesticide
petitions
are
printed
below
as
required
by
FFDCA
section
408(
d)(
3).
The
summary
of
the
petition
was
prepared
by
Bayer
CropScience,
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.

Bayer
CropScience
Interregional
Research
Project
Number
4
(
IR­
4)

PP
0F6122,
PP
3E6518,
and
PP
3E6538
EPA
has
received
pesticide
petitions
(
OF6122
and
3E6538)
from
Bayer
CropScience,
2
T.
W.
Alexander
Drive,
P.
O.
Box
12014,
Research
Triangle
Park,
NC
27709
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
residues
of
spiroxamine,
8­(
1,1­
dimethylethyl)­
N­
ethyl­
N­
propyl­
1,4­
dioxaspiro[
4,5]
decane­
2­
methanamine
in
or
on
the
raw
agricultural
commodities
as
follows:
1.
PP
0F6122
proposes
tolerances
for
grape
at
1.0
parts
per
million
(
ppm)
and
grape,
raisin
at
1.3
ppm.
2.
PP
3E6538
proposes
a
tolerance
for
banana
at
3.0
ppm.
In
addition,
EPA
has
received
a
pesticide
petition
(
3E6518)
from
the
Interregional
Research
Project
Number
4
(
IR­
4),
Technology
Centre
of
New
Jersey,
the
State
University
of
New
Jersey,
681
U.
S.
Highway
#
1
South,
North
Brunswick,
NJ
08902­
3390
proposing,
pursuant
to
section
408(
d)
of
FFDCA,
21
U.
S.
C.
346a(
d),
to
amend
40
CFR
part
180,
by
establishing
tolerances
for
residues
of
spiroxamine,
8­(
1,1­
dimethylethyl)­
N­
ethyl­
N­
propyl­
1,4­
dioxaspiro[
4,5]
decane­
2­
methanamine
in
or
on
the
raw
agricultural
commodity
hop
at
11.0
parts
per
million
(
ppm).
EPA
has
determined
that
the
petitions
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
petitions.
Additional
data
may
be
needed
before
EPA
rules
on
the
petitions.
This
notice
includes
a
summary
of
all
three
petitions
prepared
by
Bayer
CropScience,
the
manufacturer
of
spiroxamine.

A.
Residue
Chemistry
1.
Plant
metabolism.
Banana
and
grape
plant
metabolism
studies
have
been
conducted,
and
the
nature
of
the
residue
is
adequately
understood.
Animal
metabolism
studies
are
not
required
since
none
of
the
proposed
crops
to
be
treated
with
spiroxamine
are
fed
to
livestock
per
EPA's
Table
1.
Raw
Agricultural
and
Processed
Commodities
and
Feedstuffs
Derived
from
Crops.
2.
Analytical
method.
A
method
to
determine
the
total
residues
of
spiroxamine
using
gas
chromatography
has
been
submitted
to
EPA.
In
addition,
spiroxamine
has
been
evaluated
using
the
multi­
residue
methodologies
as
published
in
the
Food
and
Drug
Administration
(
FDA)
Pesticide
Analytical
Manual,
Volume
I.
3.
Magnitude
of
residues
 
i.
Grape.
Field
trials
were
conducted
at
12
locations
to
evaluate
the
quantity
of
spiroxamine,
8­(
1,1­
dimethylethyl)­
Nethyl
N­
propyl­
1,4­
dioxaspiro[
4,5]
decane­
2­
methanamine,
residues
in
grape
(
fruit)
following
treatment
of
grape
vines
with
KWG
4168
300
CS.
In
the
11
harvest
experiments
conducted,
duplicate
treated
and
single
control
samples
of
grape
(
fruit)
were
collected
at
26
to
29
days
following
the
final
application
of
KWG
4168
300
CS.
In
the
single
decline
experiment,
duplicate
samples
of
treated
grape
(
whole
fruit)
were
collected
at
21
 
28
 
,
34
 
,
and
42
 
day
pre­
harvest
intervals
(
PHIs).
In
all
trials,
the
highest
average
field
trial
(
HAFT)
residue
of
spiroxamine
observed
in
grape
was
0.61
ppm.
A
study
to
evaluate
the
quantity
of
the
residues
of
spiroxamine
in
grape
processed
commodities
following
two
foliar
spray
applications
of
KWG
4168
300
CS
was
conducted
in
which
KWG
4168
300
CS
was
applied
to
the
grape
vines
at
50%
fruit
maturity
(
56
 
day
PHI),
and
at
80%
fruit
maturity
(
28
 
day
PHI),
using
an
airblast
sprayer.
Control
and
treated
grapes
were
harvested
at
28
days
after
the
second
application
of
KWG
4168
300
CS.
The
grape
juice
and
raisins
were
evaluated
for
the
residues.
Total
spiroxamine
residues
in
the
processed
commodities
were
0.434
ppm
in
grape
juice
and
0.831
ppm
in
raisins.
The
concentration
factor
for
spiroxamine
residues
in
raisins
was
1.3X.
No
concentration
of
spiroxamine
residues
occurred
in
grape
juice.
Therefore,
a
tolerance
of
1.3
ppm
is
being
proposed
for
residues
of
spiroxamine
in
raisin,
and
no
tolerance
is
needed
for
grape
juice.
ii.
Hops.
IR­
4
has
received
a
request
from
Washington
State
for
the
use
of
spiroxamine
on
hops.
To
support
this
request,
three
fields
trials
were
performed
in
the
states
of
Washington,
Oregon
and
Idaho.
In
each
trial,
four
foliar
applications
of
KWG
4168
300
CS
spaced
8
 
14
days
apart
were
applied
to
mature
hops,
and
collected
12
 
14
days
following
the
last
application.
Spiroxamine
residue
levels
ranged
from
1.9
to
10.9
ppm.
iii.
Banana.
Twelve
field
trials
were
conducted
in
commercial
banana
plantations
of
the
major
production
areas
of
Latin
and
South
America
to
compare
the
quantity
of
residues
of
spiroxamine
in/
on
bananas
following
foliar
applications.
In
11
trials,
duplicate
composite
samples
of
bananas
were
collected
at
a
0
 
day
PHI
from
each
of
two
side­
by­
side
or
super­
imposed
plots
in
which
the
racemes
(
bunches)
were
bagged
or
unbagged.
In
one
trial,
duplicate
composite
samples
of
bananas
were
collected
at
a
0
 
,
7
 
,
14
 
,
and
21
 
day
PHI
from
each
of
the
plots
containing
bagged
and
unbagged
bananas.
The
highest
total
residue
value
of
spiroxamine
in
unwashed,
bagged,
whole
bananas
was
0.46
ppm
at
a
0
 
day
PHI.
The
highest
total
residue
value
of
spiroxamine
in
unwashed,
unbagged,
whole
bananas
was
2.44
ppm
at
a
0
 
day
PHI.
The
total
spiroxamine
residues
in
whole
bananas
appeared
to
decline
with
time.

B.
Toxicological
Profile
1.
Acute
toxicity
 
i.
KWG
4168
(
spiroxamine)
Technical.
The
acute
oral
LD50
in
male
rats
was
595
milligrams/
kilogram
(
mg/
kg)
and
in
female
rats
was
>
500
but
<
560
mg/
kg.
The
acute
dermal
LD50
in
rats
was
>
1,600
and
1,068
mg/
kg
for
males
and
females,
respectively.
The
4
 
hour
inhalation
LC50
in
rats
was
2.772
and
1.982
milligrams/
liter
(
mg/
L)
for
males
and
females,
respectively.
Irritation
studies
in
rabbits
revealed
spiroxamine
was
severely
irritating
to
the
skin
while
not
irritating
to
the
eye.
Spiroxamine
exhibited
a
skinsensitizing
potential
in
guinea
pigs
in
both
the
Magnusson/
Kligman
maximization
test
and
the
Buehler
patch
test.
ii.
Prosper
300.
The
acute
oral
LD50
in
rats
was
>
2,036
and
>
2,028
mg/
kg
for
males
and
females,
respectively.
The
acute
dermal
LD50
in
rats
was
>
5,000
mg/
kg
for
males
and
females.
The
4
 
hour
inhalation
LC50
in
rats
was
>
2.730
mg/
L
for
both
sexes.
In
an
eye
irritation
study
in
rabbits,
minimal
irritation
to
the
iris
and
conjunctiva
was
observed
with
all
irritation,
resolving
by
72
hours
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Federal
Register
/
Vol.
68,
No.
45
/
Friday,
March
7,
2003
/
Notices
post­
treatment.
In
a
dermal
irritation
study
in
rabbits,
mild
erythema
and/
or
edema
was
observed
at
72
hours
posttreatment
with
all
irritation
resolving
by
14
days
post­
treatment.
Prosper
300
did
not
have
the
potential
to
induce
dermal
sensitization
in
guinea
pigs
under
conditions
of
the
Buehler
patch
test.
2.
Genotoxicty.
The
genotoxic
action
of
spiroxamine
was
studied
in
bacteria
and
mammalian
cells
with
the
aid
of
various
in
vitro
test
systems
(
Salmonella
microsome
test,
forward
mutation
assay,
cytogenetic
study
with
Chinese
hamster
ovary
cells
and
unscheduled
DNA
synthesis
test),
and
in
one
in
vivo
test
(
micronucleus
test).
None
of
the
tests
revealed
any
evidence
of
a
mutagenic
or
genotoxic
potential
of
spiroxamine.
The
compound
did
not
induce
point
mutations,
DNA
damage
or
chromosome
aberrations.
3.
Reproductive
and
developmental
toxicity.
In
a
reproduction
study
using
rats,
spiroxamine
was
administered
for
2
generations
at
dietary
concentrations
of
20,
80,
or
300
ppm.
Reproductive
effects
such
as
reduced
litter
size
at
birth
and
clinical
signs
of
toxicity
occurred
at
the
high
dose
in
conjunction
with
maternal
toxicity.
The
parental
and
reproductive
no
observed
effect
levels
(
NOELs)
were
20
ppm
(
equal
to
2.13
mg/
kg
body
weight/
day
(
bwt/
day)
and
80
ppm
(
equal
to
9.19
mg/
kg
bwt/
day),
respectively.
In
a
developmental
toxicity
study
in
rats,
spiroxamine
was
administered
by
oral
gavage
at
dose
levels
of
0,
10,
and
25
mg/
kg
bwt/
day
and
in
a
supplemental
study
at
doses
of
0
and
150
mg/
kg
bwt/
day.
Severe
maternal
toxicity
occurred
at
150
mg/
kg
bwt/
day
resulting
in
the
deaths
of
21
of
25
animals.
Embryotoxicity
(
palatoschisis
and
omphalocele)
was
observed
at
the
high
dose
in
conjunction
with
the
severe
maternal
toxicity.
The
two
lower
dose
levels
did
not
reveal
any
maternal
or
developmental
toxicity.
The
results
of
these
studies
showed
that
the
dose
of
150
mg/
kg
bwt/
day
was
too
high
to
obtain
unequivocal
results
with
respect
to
embryotoxicity
and
teratogenicity.
In
another
oral
developmental
toxicity
study
in
rats,
spiroxamine
was
administered
by
gavage
during
gestation
at
doses
of
0,
10,
30,
or
100
mg/
kg
bwt/
day.
Developmental
toxicity
occurred
in
conjunction
with
distinct
maternal
toxicity
at
the
highest
dose
tested.
The
maternal
NOEL
was
30
mg/
kg
bwt/
day
based
on
reduced
body
weight
gain
and
feed
intake
at
100
mg/
kg
bwt/
day.
The
NOEL
for
developmental
toxicity
was
30
mg/
kg
bwt/
day
based
on
delayed
ossification,
slightly
reduced
fetal
weights
and
three
cases
of
palatoschisis
at
100
mg/
kg
bwt/
day.
In
oral
developmental
toxicity
studies
in
rabbits,
spiroxamine
was
administered
by
gavage
during
gestation
at
doses
of
0,
5,
20,
or
80
mg/
kg
bwt/
day
and
in
a
supplemental
study
at
doses
of
0
and
80
mg/
kg
bwt/
day.
The
maternal
NOEL
was
20
mg/
kg
bwt/
day
based
on
clinical
findings,
reduced
body
weight
gain,
reduced
food
intake
and
lethality
at
80
mg/
kg
bwt/
day.
The
NOEL
for
developmental
toxicity
was
20
mg/
kg
bwt/
day
based
on
marginal
developmental
toxicity
(
reduced
fetal
weight
and
a
slight
increased
rate
of
spontaneous
malformations)
at
the
highest
dose
level.
In
a
dermal
developmental
toxicity
study
in
rats,
spiroxamine
was
administered
for
6
hours/
day
during
gestation
at
doses
of
0,
5,
20,
or
80
mg/
kg.
Reduced
body
weight
gain
occurred
in
dams
at
20
mg/
kg
and
greater.
Doserelated
skin
reactions
were
observed
at
all
treated
doses.
Developmental
toxicity,
such
as
wavy
ribs,
occurred
in
conjunction
with
maternal
toxicity
at
the
highest
dose
tested.
The
NOELs
for
systemic
and
local
maternal
toxicity
were
5
and
<
5
mg/
kg,
respectively.
The
NOEL
for
developmental
toxicity
was
20
mg/
kg.
Spiroxamine
did
not
reveal
any
teratogenic
potential
associated
with
dermal
application.
4.
Subchronic
toxicity.
In
subacute
dermal
toxicity
studies,
rabbits
were
treated
with
spiroxamine
at
doses
ranging
from
0.05
to
5
mg/
kg
bwt/
day
for
6
hours/
day
over
a
period
of
3
weeks.
Systemic
effects
were
not
observed
in
these
studies.
Local
irritation,
increased
skin
fold
thickness,
and
histopathological
findings
of
the
skin
occurred
in
these
studies.
The
overall
NOELs
for
local
and
systemic
effects
were
0.2
and
5
mg/
kg
bwt/
day,
respectively.
In
a
90
 
day
feeding
study,
mice
were
administered
spiroxamine
at
dietary
concentrations
of
0,
20,
80,
320,
or
1,280
ppm.
Effects
observed
included
clinical
signs
of
toxicity,
decreased
body
weight
and
food
consumption,
changes
in
hematological
parameters,
hyperplastic
changes
in
the
epidermis
of
the
auricles
and/
or
tail,
and
effects
on
the
liver,
kidney,
and
urinary
bladder.
The
NOEL
was
20
ppm
(
equal
to
6.2
mg/
kg
bwt/
day)
for
male
mice
based
on
marginally
reduced
body
weight
development
at
80
ppm.
The
NOEL
for
female
mice
was
80
ppm
(
equal
to
28.5
mg/
kg
bwt/
day)
based
on
slight
morphological
findings
in
the
liver
at
320
ppm.
In
another
subchronic
mouse
study,
spiroxamine
was
administered
by
oral
gavage
at
doses
of
0,
60,
180
or
240
mg/
kg.
Effects
observed
included
clinical
signs
of
toxicity,
and
effects
of
the
liver,
urinary
bladder
and
hyperplastic
changes
in
the
epidermis
of
the
auricles
and
tails.
Evidence
of
liver
enzyme
induction
was
seen
in
all
treatment
groups.
The
NOEL
was
<
60
mg/
kg
bwt/
day
for
both
males
and
females.
Spiroxamine
was
administered
to
rats
in
a
subchronic
feeding
study
at
dietary
concentrations
of
0,
25,
125,
or
625
over
a
period
of
13
weeks.
Effects
included
clinical
signs
of
toxicity,
reduced
body
weight
gains,
changes
in
hematological
parameters,
and
effects
on
the
liver,
urinary
bladder,
esophagus
and
forestomach.
The
NOEL
both
male
and
female
was
25
ppm
(
equal
to
1.9
and
2.7
mg/
kg
bw/
day,
respectively)
based
on
histopathological
findings
in
the
esophagus
and
forestomach
at
125
pwas
administered
at
dietary
concentrations
of
0,
25,
750
or
1,500
ppm
and
at
0,
150,
250
or
500
ppm
over
a
period
of
13
weeks.
Toxicological
effects
included
changes
in
clinical
chemistries,
increased
relative
liver
weights,
and
histopathological
findings
in
the
liver.
The
overall
NOELs
from
these
studies
were
500
(
equal
to
16.9
mg/
kg
bw/
day)
and
750
ppm
(
equal
to
21.29
mg/
kg
bw/
day)
for
males
and
females,
respectively,
based
on
liver
effects.
5.
Chronic
toxicity.
In
a
chronic
dog
study,
Spiroxamine
was
administered
at
dietary
concentrations
of
0,
25,
75,
1,000
or
2,000
ppm
for
a
period
of
52
weeks.
Effects
included
opthalmological
findings,
changes
in
clinical
chemistries,
mild
anemia,
and
histopathological
findings
(
eye
and
liver).
The
NOEL
for
both
sexes
was
75
ppm
(
equal
to
2.47
and
2.48
mg/
kg
bw/
day
for
males
and
females,
respectively)
based
on
eye
and
liver
effects.
Rats
were
administered
Spiroxamine
for
2
years
at
dietary
concentrations
of
0,
10,
70
or
490
ppm.
Effects
included
reduced
body
weight
gains,
a
slight
increase
in
mortality
and
histopathological
findings
in
the
esophagus
and
urinary
bladder.
The
NOEL
for
both
sexes
was
70
ppm
(
equal
to
4.22
and
5.67
mg/
kg
bw/
day
for
males
and
females,
respectively)
based
on
esophagus
and
urinary
bladder
effects.
The
carcinogenicity
potential
of
Spiroxamine
was
investigated
in
rats
and
mice
at
maximum
dietary
concentrations
of
490
ppm
(
equal
to
32.81
mg/
kg
bw/
day)
and
600
ppm
(
equal
to
149.8
mg/
kg
bw/
day),
respectively.
No
evidence
of
an
oncogenic
potential
of
Spiroxamine
was
found
in
the
long­
term
studies
in
rats
and
mice.
6.
Animal
metabolism.
Rats
were
gavaged
with
1
or
100
mg/
kg
radiolabeled
technical
Spiroxamine.
Seventy
percent
of
the
oral
low
dose
was
absorbed.
Within
48
hours
of
dosing,
over
97
percent
of
the
dose
was
excreted
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Notices
in
urine
and
feces.
At
sacrifice
(
48
hours
post
dosing),
the
radioactivity
remaining
in
the
body
was
below
1
percent
in
the
low
dose
groups
and
approximately
1
percent
and
2
percent
in
the
male
and
female
rats,
espectively,
from
the
high
dose
group.
Concentrations
found
in
tissues
and
organs
were
relatively
low:
i.
e.,
they
do
not
exceed
0.04
µ
g/
g.
The
highest
concentrations
were
found
in
liver,
thymus
and
adrenals.
Slightly
smaller
concentrations
were
observed
in
the
thyroid,
spleen,
fat,
ovaries
and
uterus.
The
main
metabolite
in
all
dose
groups
is
Spiroxamine
oxidized
to
the
carboxylic
acid
in
the
t­
butyl­
moiety.
The
identification
rate
was
approximately
77
percent
of
the
recovered
radioactivity
in
all
dose
groups.
7.
Metabolite
toxicology.
Toxicological
studies
have
been
conducted
on
KWG
4,168
N­
oxide,
a
plant
and
animal
metabolite
of
KWG
4168.
In
an
acute
oral
toxicity
study
on
KWG
4,168
N­
oxide
using
female
rats,
the
LD50
was
707
mg/
kg.
In
a
subacute
toxicity
study,
rats
were
administered
KWG
4168
N­
oxide
at
dietary
concentrations
of
0,
30,
150
and
1,000
ppm.
The
highest
concentration
resulted
in
treatment­
related
effects.
The
main
targets
were
the
epithelia
of
the
digestive
tract
and
the
urinary
bladder.
A
mild
liver
enzyme
induction
was
observed
without
any
correlating
gross­
or
micropathological
findings.
In
a
subchronic
study,
rats
were
administered
KWG
4168
N­
oxide
at
dietary
concentrations
of
0,
25,
125
and
625
ppm,
and
KWG
4168
at
625
ppm.
Toxic
effects
were
observed
at
625
ppm
for
both
test
substances.
Similar
effects
included
delayed
body
weight
development,
changes
in
clinical
chemistries
and
micropathological
findings
of
the
esophagus
and
stomach.
The
effects
were
less
pronounced
for
KWG
4168
N­
oxide
when
compared
to
KWG
4168
(
parent).
Effects
noted
only
in
animals
treated
with
KWG
4168
included
changes
in
hematological
parameters
and
micropathological
findings
of
the
urinary
bladder
(
females).
The
mutagenic
potential
of
KWG
4168
N­
oxide
was
studied
in
vitro
in
bacteria
and
mammalian
cells.
It
did
not
cause
mutations
in
vitro
in
the
Ames
assay,
the
V­
79­
HPRT
gene
mutation
assay,
or
produce
clastogenicity
in
the
chromosome
aberration
assay
with
or
without
metabolic
activation.
8.
Endocrine
disruption.
The
toxicology
database
for
Spiroxamine
is
current
and
complete.
Studies
in
this
database
include
evaluation
of
the
potential
effects
on
reproduction
and
development,
and
an
evaluation
of
the
pathology
of
the
endocrine
organs
following
short­
or
long­
term
exposure.
These
studies
revealed
no
primary
endocrine
effects
due
to
Spi
primary
endocrine
effects
due
to
spiroxamine.

C.
Aggregate
Exposure
1.
Dietary
exposure.
An
aggregate
risk
assessment
was
conducted
to
assess
the
potential
acute
and
chronic
dietary
exposure
from
applications
of
spiroxamine
on
grape,
hop,
and
banana
(
imported).
Novigen
Sciences,
Inc.'
s
Dietary
Exposure
Evaluation
Model
(
DEEM)
was
used
to
estimate
the
chronic
and
acute
dietary
exposure.
For
the
acute
dietary
analysis,
the
proposed
acute
reference
dose
(
aRfD)
of
0.1
mg/
kg/
day
was
used.
This
aRfD
is
based
on
NOELs
of
10
mg/
kg
from
an
acute
oral
toxicity
and
an
acute
neurotoxicity
screening
study
and
applying
a
100­
fold
uncertainty
factor.
For
the
chronic
dietary
analysis,
the
proposed
chronic
reference
dose
cRfD
of
0.02
mg/
kg/
day
was
used.
This
cRfD
is
based
on
a
parental
toxicity
NOEL
of
2.13
mg/
kg/
day
from
the
two­
generation
reproduction
study
and
the
application
of
a
100­
fold
uncertainty
factor.
Results
from
the
acute
and
chronic
dietary
exposure
analyses
described
below
demonstrate
a
reasonable
certainty
that
no
harm
to
the
overall
U.
S.
population
or
any
population
subgroup
will
result
from
the
use
of
spiroxamine
on
grape,
hop,
and
banana.
i.
Food.
An
acute
dietary
(
food)
risk
assessment
was
conducted
using
the
highest
residue
values
and
100%
crop
treated.
The
estimated
percent
of
the
aRfD
for
the
overall
U.
S.
population
(
all
seasons)
at
the
95
percentile
are
8.4%.
The
most
highly
exposed
population
subgroup,
non­
nursing
infants,
had
an
exposure
equal
to
33.3%
of
the
aRfD
at
the
95
percentile.
These
exposure
estimates
are
within
EPA's
criteria
of
acceptability.
A
chronic
dietary
analysis
was
conducted
using
average
residue
values
and
100%
crop
treated.
The
estimated
percent
of
the
cRfD
for
the
overall
U.
S.
population
(
all
seasons)
was
8.8%.
For
the
most
highly
exposed
population
subgroup,
children
(
1
 
6
years),
the
exposure
equaled
30.6%
of
the
cRfD.
These
exposure
estimates
are
within
EPA's
criteria
of
acceptability.
ii.
Drinking
water.
No
monitoring
data
are
available
for
residues
of
spiroxamine
in
ground
water,
and
EPA
has
established
no
health
advisory
levels
or
maximum
contaminant
levels
for
residues
of
spiroxamine
in
drinking
water.
Studies
show
low
to
no
soil
mobility
for
spiroxamine
and
its
primary
metabolites.
In
addition,
field
studies
show
that
spiroxamine
and
its
degradates
do
not
leach
below
the
6
 
inch
depth
level,
and
show
very
low
potential
to
leach
into
ground
water.
Therefore,
it
can
be
concluded
with
reasonable
certainty
that
no
harm
will
result
from
acute
or
chronic
aggregate
exposure
to
spiroxamine
residues
in
drinking
water.
2.
Non­
dietary
exposure.
Spiroxamine
is
not
registered
nor
are
registrations
pending
for
uses
that
would
result
in
non­
dietary
exposure.

D.
Cumulative
Effects
Spiroxamine
belongs
to
a
new
class
of
chemistry
known
as
spiroketalamines.
Therefore,
for
this
tolerance
petition,
it
is
assumed
that
spiroxamine
does
not
have
a
common
mechanism
of
toxicity
with
other
substances
and
only
the
potential
risks
of
spiroxamine
in
its
aggregate
exposure
are
considered.

E.
Safety
Determination
1.
U.
S.
population.
Based
on
the
above
aggregate
food
exposure
estimates
for
the
overall
U.
S.
population
8.4%
of
the
aRfD
and
(
8.8%
of
the
cRfD),
the
low
potential
for
spiroxamine
and
its
degradates
to
leach
into
ground
water,
and
the
completeness
of
the
toxicity
data
base,
there
is
reasonable
certainty
that
no
harm
to
the
U.
S.
population
will
result
from
aggregate
exposure
to
spiroxamine.
2.
Infants
and
children.
In
assessing
the
potential
for
additional
sensitivity
of
infants
and
children
to
residues
of
spiroxamine,
data
from
developmental
toxicity
studies
in
mice,
rats,
rabbits
and
a
2­
generation
reproduction
study
in
the
rat
are
considered.
The
developmental
toxicity
studies
are
designed
to
evaluate
adverse
effects
on
the
developing
organism
resulting
from
maternal
pesticide
exposure
during
gestation.
Reproduction
studies
provide
information
relating
to
effects
from
exposure
to
the
pesticide
on
the
reproductive
capability
of
mating
animals
and
data
on
systemic
toxicity.
Based
on
the
above
aggregate
food
exposure
estimates
for
the
most
highly
exposed
population
subgroup,
nonnursing
infants
(
33.3%
of
the
aRfD),
and
children
1
 
6
years
(
30.6%
of
the
cRfD),
the
low
potential
for
spiroxamine
and
its
degradates
to
leach
into
ground
water,
and
on
the
completeness
of
the
toxicity
data
base,
there
is
reasonable
certainty
that
no
harm
to
infants
and
children
will
result
from
aggregate
exposure
to
spiroxamine.

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45
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7,
2003
/
Notices
F.
International
Tolerances
There
are
no
established
codex,
Canadian
or
Mexican
maximum
residue
levels
for
spiroxamine.
[
FR
Doc.
03
 
5316
Filed
3
 
6
 
03;
8:
45
am]

BILLING
CODE
6560
 
50
 
S
ENVIRONMENTAL
PROTECTION
AGENCY
[
OPP
 
2003
 
0025;
FRL
 
7289
 
8]

Pyriproxyfen;
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
pesticide
petitions
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
 
0025,
must
be
received
on
or
before
April
7,
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:
Shaja
R.
Brothers,
Registration
Division
(
7505C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001;
telephone
number:
(
703)
308
 
3194;
e­
mail
address:
brothers.
shaja@
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
producers
(
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.
To
determine
whether
you
or
your
business
may
be
affected
by
this
action,
you
should
carefully
examine
the
applicability
provisions.
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
 
0025.
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
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
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