Document ID: EPA-HQ-OPPT-2003-0064-0001
Agency: epa
Document Type: Notice
Title: Endocrine Disruptor Methods Validation Subcommittee (EDMVS) under the National Advisory Council for Environmental Policy and Technology (NACEPT); Notice of Public Meeting
Posted Date: 2003-11-21T05:00Z

65706
Federal
Register
/
Vol.
68,
No.
225
/
Friday,
November
21,
2003
/
Notices
415
 
1444.
Revision
of
FR
Notice
Published
on
11/
14/
03:
CEQ
Comment
Period
Ending
12/
29/
2003
has
been
Extended
to
1/
27/
2004.

Dated:
November
18,
2003.
Joseph
C.
Montgomery,
Director,
NEPA
Compliance
Division,
Office
of
Federal
Activities.
[
FR
Doc.
03
 
29190
Filed
11
 
20
 
03;
8:
45
am]

BILLING
CODE
6560
 
50
 
P
ENVIRONMENTAL
PROTECTION
AGENCY
[
OPPT
 
2003
 
0064;
FRL
 
7334
 
5]

Endocrine
Disruptor
Methods
Validation
Subcommittee
under
the
National
Advisory
Council
for
Environmental
Policy
and
Technology;
Notice
of
Public
Meeting
AGENCY:
Environmental
Protection
Agency
(
EPA).
ACTION:
Notice.

SUMMARY:
There
will
be
a
meeting
of
the
Endocrine
Disruptor
Methods
Validation
Subcommittee
(
EDMVS),
a
subcommittee
under
the
National
Advisory
Council
for
Environmental
Policy
and
Technology
(
NACEPT),
on
December
10
 
12,
2003.
The
purpose
of
this
meeting
is
to:
Receive
advice
and
input
from
the
EDMVS
on:
The
Pubertals
assay
and
Aromatase
assay
prevalidation
results;
receive
the
introductory
presentation
on
Adult
Intact
Male
assay;
and
receive
updates
on:
The
Androgen
Receptor
Binding
assay,
efforts
to
finalize
reference
chemicals,
and
the
Organization
for
Economic
Cooperation
and
Development
(
OECD)
Fish
Drafting
Group.
DATES:
The
meeting
will
be
held
on
Wednesday,
December
10,
2003,
from
1
p.
m.
to
4:
45
p.
m.;
Thursday,
December
11,
2003,
from
8:
30
a.
m.
to
5
p.
m.;
and
Friday,
December
12,
2003,
from
8:
30
a.
m.
to
Noon,
eastern
standard
time.
Requests
to
participate
in
the
meeting
must
be
received
by
EPA
on
or
before
December
5,
2003.
To
ensure
proper
receipt
by
EPA,
it
is
imperative
that
you
identify
docket
ID
number
OPPT
 
2003
 
0064
in
the
subject
line
on
the
first
page
of
your
request.
Individuals
requiring
special
accommodations
at
the
meeting,
including
wheelchair
access,
should
contact
the
technical
person
listed
under
FOR
FURTHER
INFORMATION
CONTACT
at
least
5
business
days
prior
to
the
meeting.
ADDRESSES:
The
meeting
will
be
held
at
RESOLVE,
1255
23rd
St.,
NW.,
Suite
275,
Washington,
DC.
Requests
to
participate
in
the
meeting
may
be
submitted
by
e­
mail,
telephone,
fax,
or
through
hand
delivery/
courier.
Follow
the
detailed
instructions
as
provided
in
Unit
I.
of
the
SUPPLEMENTARY
INFORMATION.
Comments
may
be
submitted
electronically,
by
fax,
or
through
hand
delivery/
courier.
Follow
the
detailed
instructions
as
provided
in
Unit
I.
of
the
SUPPLEMENTARY
INFORMATION.
FOR
FURTHER
INFORMATION
CONTACT:
For
general
information
contact:
Barbara
Cunningham,
Director,
Environmental
Assistance
Division
(
7408M),
Office
of
Pollution
Prevention
and
Toxics,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001;
telephone
number:
(
202)
554
 
1404;
e­
mail
address:
TSCAHotline
epa.
gov.
For
technical
information
contact:
Jane
Smith,
Designated
Federal
Official
(
DFO),
Exposure
Assessment
Coordination
and
Policy
Division
(
7203M),
Office
of
Science
Coordination
and
Policy,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001;
telephone
number:
(
202)
564
 
8476;
fax
number:
(
202)
564
 
8482;
e­
mail
address:
smith.
jane­
scott@
epa.
gov.
SUPPLEMENTARY
INFORMATION:

I.
General
Information
A.
Does
this
Action
Apply
to
Me?
This
action
is
directed
to
the
public
in
general.
This
action
may,
however,
be
of
interest
if
you
produce,
manufacture,
use,
consume,
work
with,
or
import
pesticide
chemicals
and
other
substances.
To
determine
whether
you
or
your
business
may
have
an
interest
in
this
notice
you
should
carefully
examine
section
408(
p)
of
the
Federal
Food,
Drug,
and
Cosmetic
Act
(
FFDCA),
as
amended
by
the
Food
Quality
Protection
Act
(
FQPA)
of
1996
(
Public
Law
104
 
170),
21
U.
S.
C.
346a(
p),
and
amendments
to
the
Safe
Drinking
Water
Act
(
SDWA)
(
Public
Law
104
 
182),
42
U.
S.
C.
300j
 
17.
Since
other
entities
may
also
be
interested,
the
Agency
has
not
attempted
to
describe
all
the
specific
entities
that
may
be
interested
in
this
action.
If
you
have
any
questions
regarding
this
action,
consult
the
technical
person
listed
under
FOR
FURTHER
INFORMATION
CONTACT.

B.
How
Can
I
Get
Additional
Information,
Including
Copies
of
this
Document
or
Other
Related
Documents?
1.
Docket.
EPA
has
established
an
official
public
docket
for
this
action
under
docket
identification
(
ID)
number
OPPT
 
2003
 
0064.
The
official
public
docket
consists
of
the
documents
specifically
referenced
in
this
action,
any
public
comments
received,
and
other
related
information.
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
are
available
for
public
viewing
at
the
EPA
Docket
Center,
Rm.
B102
 
Reading
Room,
EPA
West,
1301
Constitution
Ave.,
NW.,
Washington,
DC.
The
EPA
Docket
Center
is
open
from
8:
30
a.
m.
to
4:
30
p.
m.,
Monday
through
Friday,
excluding
legal
holidays.
The
EPA
Docket
Center
Reading
Room
telephone
number
is
(
202)
566
 
1744
and
the
telephone
number
for
the
OPPT
Docket,
which
is
located
in
EPA
Docket
Center,
is
(
202)
566
 
0282.
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/.
A
meeting
agenda,
a
list
of
EDMVS
members,
and
information
from
previous
meetings
are
available
electronically,
from
the
EPA
Internet
Home
Page
at
http://
www.
epa.
gov/
scipoly/
oscpendo/
edmvs.
htm.
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.
Once
in
the
system,
select
``
search,''
then
key
in
the
appropriate
docket
ID
number.

C.
How
Can
I
Request
to
Participate
in
the
Meeting
or
Submit
Comments?
You
may
submit
a
request
to
participate
in
the
meeting
through
email
telephone,
fax,
or
hand
delivery/
courier.
We
would
normally
accept
requests
by
mail,
but
in
this
time
of
delays
in
delivery
of
government
mail
due
to
health
and
security
concerns,
we
cannot
assure
your
request
would
arrive
in
a
timely
manner.
Do
not
submit
any
information
in
your
request
that
is
considered
CBI.
Your
request
must
be
received
by
EPA
on
or
before
December
5,
2003.
To
ensure
proper
receipt
by
EPA,
it
is
imperative
that
you
identify
docket
ID
number
OPPT
 
2003
 
0064
in
the
subject
line
on
the
first
page
of
your
request.
In
accordance
with
the
Federal
Advisory
Committee
Act
(
FACA),
the
public
is
encouraged
to
submit
written
comments
on
the
topic
of
this
meeting.

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65707
Federal
Register
/
Vol.
68,
No.
225
/
Friday,
November
21,
2003
/
Notices
The
EDMVS
will
have
a
brief
period
available
during
the
meeting
for
public
comment.
It
is
the
policy
of
the
EDMVS
to
accept
written
public
comments
of
any
length,
and
to
accommodate
oral
public
comments
whenever
possible.
The
EDMVS
expects
that
public
statements
presented
at
its
meeting
will
be
on
the
meeting
topic
and
not
be
repetitive
of
previously
submitted
oral
or
written
statements.
1.
Electronically.
If
you
submit
an
electronic
request
to
participate
in
the
meeting
or
comments
as
prescribed
in
this
unit,
EPA
recommends
that
you
include
your
name,
mailing
address,
and
an
e­
mail
address
or
other
contact
information
in
the
body
of
your
request
or
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
request
or
comment
and
allows
EPA
to
contact
you
in
case
EPA
cannot
read
your
request
or
comment
due
to
technical
difficulties
or
needs
further
information
on
the
substance
of
your
request
or
comment.
EPA's
policy
is
that
EPA
will
not
edit
your
request
or
comment,
and
any
identifying
or
contact
information
provided
in
the
body
of
a
request
or
comment
will
be
included
as
part
of
the
request
or
comment
that
is
placed
in
the
official
public
docket,
and
made
available
in
EPA's
electronic
public
docket.
If
EPA
cannot
read
your
request
or
comment
due
to
technical
difficulties
and
cannot
contact
you
for
clarification,
EPA
may
not
be
able
to
consider
your
request
or
comment.
i.
EPA
Docket.
You
may
use
EPA's
electronic
public
docket
to
submit
a
request
to
participate
in
the
meeting
or
to
submit
comments.
Go
to
EPA
Dockets
at
http://
www.
epa.
gov/
edocket/,
and
follow
the
online
instructions
for
submitting
materials.
Once
in
the
system,
select
``
search,''
and
then
key
in
docket
ID
number
OPPT
 
2003
 
0064.
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
request.
ii.
E­
mail.
Requests
to
participate
in
the
meeting
or
comments
may
be
sent
by
e­
mail
to
oppt.
ncic@
epa.
gov,
Attention:
Docket
ID
Number
OPPT
 
2003
 
0064.
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
request
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
request
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
by
hand
delivery,
courier,
or
package
service,
such
as
Federal
Express,
to
the
technical
person
listed
under
FOR
FURTHER
INFORMATION
CONTACT.
These
electronic
submissions
will
be
accepted
in
WordPerfect
or
ASCII
file
format.
Avoid
the
use
of
special
characters
and
any
form
of
encryption.
Do
not
submit
any
disk
or
CD
ROM
through
the
mail.
Disks
and
CD
ROMs
risk
being
destroyed
when
handled
as
Federal
Government
mail.
2.
Telephone
or
fax.
Telephone
or
fax
your
request
to
participate
in
the
meeting
to
the
technical
person
listed
under
FOR
FURTHER
INFORMATION
CONTACT.
3.
By
hand
delivery
or
courier.
Deliver
your
comments
to:
OPPT
Document
Control
Office
(
DCO)
in
EPA
East
Bldg.,
Rm.
6428,
1201
Constitution
Ave.,
Washington,
DC.
Attention:
Docket
ID
Number
OPPT
 
2003
 
0064.
The
DCO
is
open
from
8
a.
m.
to
4
p.
m.,
Monday
through
Friday,
excluding
legal
holidays.
The
telephone
number
for
the
DCO
is
(
202)
564
 
8930.

II.
Background
In
1996,
through
enactment
of
FQPA,
which
amended
the
FFDCA,
Congress
directed
EPA
to
develop
a
screening
program,
using
appropriate
validated
test
systems
and
other
scientifically
relevant
information,
to
determine
whether
certain
substances
may
have
hormonal
effects
in
humans.
In
1996,
EPA
chartered
a
scientific
advisory
committee,
the
Endocrine
Disruptor
Screening
and
Testing
Advisory
Committee
(
EDSTAC),
under
the
authority
of
FACA,
to
advise
it
on
establishing
a
program
to
carry
out
Congress'
directive.
EDSTAC
recommended
a
multi­
step
approach
including
a
series
of
screens
(
Tier
1
screens)
and
tests
(
Tier
2
tests)
for
determining
whether
a
chemical
substance
may
have
an
effect
similar
to
that
produced
by
naturally
occurring
hormones.
EPA
adopted
almost
all
of
EDSTAC's
recommendations
in
the
program
that
it
developed,
the
Endocrine
Disruptor
Screening
Program
(
EDSP),
to
carry
out
Congress'
directive.
EDSTAC
also
recognized
that
there
currently
are
no
validated
test
systems
for
determining
whether
a
chemical
may
have
an
effect
in
humans
that
is
similar
to
an
effect
produced
by
naturally
occurring
hormones.
Consequently,
EPA
is
in
the
process
of
developing
and
validating
the
screens
and
tests
that
EDSTAC
recommended
for
inclusion
in
the
EDSP.
In
carrying
out
this
validation
exercise,
EPA
is
working
closely
with,
and
adhering
to
the
principles
of
the
Interagency
Coordinating
Committee
for
the
Validation
of
Alternate
Methods
(
ICCVAM).
EPA
also
is
working
closely
with
the
OECD's
Endocrine
Testing
and
Assessment
Task
Force
to
validate
and
harmonize
endocrine
screening
tests
of
international
interest.
Finally,
to
ensure
that
EPA
has
the
best
and
most
up­
to­
date
advice
available
regarding
the
validation
of
the
screens
and
tests
in
the
EDSP,
EPA
established
the
EDMVS
under
NACEPT.
EDMVS
provides
independent
advice
and
counsel
to
the
Agency
through
NACEPT,
on
scientific
and
technical
issues
related
to
validation
of
the
EDSP
Tier
1
screens
and
Tier
2
tests,
including
advice
on
methods
for
reducing
animal
use,
refining
procedures
involving
animals
to
make
them
less
stressful,
and
replacing
animals
where
scientifically
appropriate.
The
EDMVS
has
held
eight
meetings
since
its
establishment
in
September
2001.
October
2001
The
objectives
of
the
first
meeting,
which
was
held
in
October
2001,
(
docket
control
number
OPPTS
 
42212D)
were
for
EPA
to
provide:
1.
An
overview
of
the
EPA's
Endocrine
Disruptor
Program.
2.
Background
information
on
test
protocol
validation
and
approaches.
3.
For
the
EDMVS
to
develop
a
clear
understanding
of
their
scope,
purpose,
and
operating
procedures.
4.
The
EDMVS
and
the
EDSP
to
determine
the
next
steps.
December
2001
The
objectives
of
the
December
2001
meeting
(
docket
control
number
OPPTS
 
42212E)
were
for
the
EDMVS
to
provide
input
and
advice
on:
1.
EDMVS's
mission
statement
and
work
plan.
2.
The
In
Utero
Through
Lactation
assay
detailed
review
paper.
3.
The
Pubertal
assay
study
design
for
the
Multi­
Dose
and
Chemical
Array
Protocols.
4.
The
mammalian
1­
generation
study
design.
March
2002
The
objectives
of
the
March
2002
meeting
(
docket
control
number
OPPTS
 
42212F)
were
for
the
EDMVS
to
provide
input
and
advice
on:
1.
EPA's
implementation
process
and
practical
aspects
of
validation.
2.
The
In
Utero
Through
Lactation
Assay
Protocol.
3.
The
Fish
Reproduction
assay
detailed
review
paper.

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Federal
Register
/
Vol.
68,
No.
225
/
Friday,
November
21,
2003
/
Notices
4.
Special
studies,
the
Fathead
Minnow
assays,
Vitellogenin
assay,
and
Avian
Dosing
Protocol.
5.
The
steroidogenesis
detailed
review
paper.
6.
The
aromatase
detailed
review
paper.
7.
A
proposed
standard
suite
of
chemicals
for
testing
in
the
Tier
1
Screening
assays.
8.
The
current
efforts
related
to
evaluating
the
relevance
of
animal
data
to
human
health.
9.
EPA's
approach
to
addressing
lowdose
issues.
June
2002
The
objective
of
the
June
2002
teleconference
meeting
(
docket
ID
number
OPPT
 
2002
 
0020)
was
for
the
EDMVS
to
provide
input
and
advice
on
the
steroidogenesis
detailed
review
paper.
July
2002
The
objectives
of
the
July
2002
meeting
(
docket
ID
number
OPPT
 
2002
 
0029)
were:
1.
To
review
the
screening
criteria,
recommended
by
EDSTAC
and
adopted
by
EDSP
for
screens.
2.
To
receive
an
update
of
the
NICEATM
estrogen
and
androgen
receptor
binding
efforts.
3.
To
discuss
and
provide
advice
on
general
dose
setting
issues;
and
to
provide
comments
and
advice
on:
 
A
pubertal
(
special
study)
 
restricted
feeding.
 
A
mammalian
2­
generation
(
draft)
 
Propylthiouracil
(
PTU)
special
study.
 
An
amphibian
metamorphosis
detailed
review
paper.
 
An
invertebrate
detailed
review
paper.
December
2002
The
objective
of
the
December
2002
teleconference
meeting
(
docket
ID
number
OPPT
 
2002
 
0059)
was
for
the
EDMVS
to
provide
input
and
advice
on
the
Tier
2
Fish
Life
Cycle
assay
detailed
review
paper.
June
2003
The
objectives
of
the
June
5
 
6,
2003
meeting
(
docket
ID
number
OPPT
 
2003
 
0016)
were
for
the
EDMVS
to
provide
input
and
advice
on:
1.
The
Tier
II
Mammalian
2­
Generation
Special
Study
and
the
1­
generation
extension
results.
2.
The
Tier
I
Steroidogenesis
(
Sliced
Testes)
Study
results
and
validation
plan.
3.
The
Tier
I
Pre­
Optimization,
substrate
characterization
for
Aromatase
Placental
Microsomes
Study
results.
August
2003
The
objectives
of
the
August
18
 
20,
2003
meeting
(
docket
ID
number
OPPT
 
2003
 
0027)
were:
1.
Review
and
discuss
the
status/
results
of
the
prevalidation
work
on:

 
The
Fish
Screening
assay,
specifically:
The
survey
of
vitellogenin
methods
in
Fathead
Minnow,
Zebrafish,
and
Medaka;
the
comparative
evaluation
of
the
Fathead
Minnow
assays;
and
the
Fish
Screen
(
Non­
Spawning)
assay.

 
The
Steroidogenesis
Assay
Optimized
Protocol.
2.
Provide
input
and
advice
on
the:

 
EDSP's
validation
plans
for
the
Fish
Screening
assay
and
Steroidogenesis
assay.

 
Strain/
species
white
paper.

 
Chemicals
used
in
EDSP's
prevalidation
and
validation.

 
Avian
detailed
review
paper.

 
Issues
related
to
the
Pubertal
assays.
3.
Receive
an
update
on
the
amphibian
workshop
conducted
recently.

III.
Meeting
Objectives
for
the
December
2003
Meeting
The
objectives
for
the
December
10
 
12,
2003
meeting
(
docket
ID
number
OPPT
 
2003
 
0064)
are
for
EDMVS
to
provide
input
and
advice
on:
1.
Discuss
the
Pubertals
assay
and
Aromatase
assay
prevalidation
results
and
recommend
next
steps.
2.
Receive
introductory
presentation
on
Adult
Intact
Male
assay.
3.
Receive
updates
on:

 
Androgen
Receptor
Binding
assay.

 
Efforts
to
finalize
reference
chemicals.

 
OECD
Fish
Drafting
Group.

 
Activities
regarding
In
Vitro
Fish
assays.
A
list
of
the
EDMVS
members
and
meeting
materials
are
available
on
our
web
site
(
http://
www.
epa.
gov/
scipoly/
oscpendo/
edmvs.
htm)
and
in
the
public
docket.

List
of
Subjects
Environmental
protection,
Endocrine
disruptors,
Hazardous
substances,
Health,
Safety.

Dated:
November
14,
2003.

Joseph
J.
Merenda,
Jr.,

Director,
Office
of
Science
Coordination
and
Policy.
[
FR
Doc.
03
 
29186
Filed
11
 
20
 
03;
8:
45
am]

BILLING
CODE
6560
 
50
 
S
ENVIRONMENTAL
PROTECTION
AGENCY
[
OPP
 
2003
 
0336;
FRL
 
7333
 
7]

Dichlormid;
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
 
0336,
must
be
received
on
or
before
December
22,
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:
Princess
Campbell,
Registration
Division
(
7505C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001;
telephone
number:
(
703)
308
 
8033;
e­
mail
address:
campbell.
princess@
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
code
111)
 
Animal
production
(
NAICS
code
112)
 
Food
manufacturing
(
NAICS
code
311)
 
Pesticide
manufacturing
(
NAICS
code
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
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2003
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