Document ID: EPA-HQ-OPP-2002-0352-0001
Agency: epa
Document Type: Notice
Title: Experimental Use Permit; Receipt of Application
Posted Date: 2003-04-02T05:00Z

16050
Federal
Register
/
Vol.
68,
No.
63
/
Wednesday,
April
2,
2003
/
Notices
2.
Non­
dietary
exposure.
There
is
a
potential
residential
post­
application
exposure
to
adults
and
children
entering
residential
areas
treated
with
fludioxonil.
Since
the
Agency
did
not
select
a
short­
term
endpoint
for
dermal
exposure,
only
intermediate
dermal
exposures
were
considered.
Based
on
the
residential
use
pattern,
Syngenta
believes
that
no
long­
term
postapplication
residential
exposure
is
expected.
3.
Chronic
aggregate
exposure.
Based
on
the
completeness
and
reliability
of
the
toxicity
data
supporting
these
petitions,
Syngenta
believes
that
there
is
a
reasonable
certainty
that
no
harm
will
result
from
aggregate
exposure
to
residues
arising
from
all
current
and
proposed
fludioxonil
uses,
including
anticipated
dietary
exposure
from
food,
water,
and
all
other
types
of
nonoccupational
exposures.

D.
Cumulative
Effects
Section
408(
b)(
2)(
D)(
v)
requires
that,
when
considering
whether
to
establish,
modify,
or
revoke
a
tolerance,
the
Agency
consider
``
available
information''
concerning
the
cumulative
effects
of
a
particular
pesticide's
residues
and
``
other
substances
that
have
a
common
mechanism
of
toxicity.''
EPA
does
not
have,
at
this
time,
available
data
to
determine
whether
fludioxonil
has
a
common
mechanism
of
toxicity
with
other
substances
or
how
to
include
this
pesticide
in
a
cumulative
risk
assessment.
For
the
purposes
of
this
tolerance
action,
EPA
has
not
assumed
that
fludioxonil
has
a
common
mechanism
of
toxicity
with
other
substances.

E.
Safety
Determination
The
chronic
dietary
exposure
analysis
(
food
only)
showed
that
exposure
from
all
established
and
proposed
fludioxonil
uses
would
be
3.75%
of
the
cRfD
for
the
most
sensitive
subpopulation,
children
1
and
2
years
old.
Additionally,
for
females
13
 
50
years
old,
the
acute
dietary
exposure
analysis
(
food
only)
showed
that
exposure
from
all
established
and
proposed
fludioxonil
uses
would
be
1.01%
of
the
aPAD.
EPA
has
determined
that
reliable
data
support
using
the
standard
MOE
and
uncertainty
factor
(
100
for
combined
interspecies
and
intraspecies
variability)
for
fludioxonil
and
that
an
additional
safety
factor
of
10
is
not
necessary
to
be
protective
of
infants
and
children.
Acute
DWLOCs
were
calculated
based
on
an
aPAD
of
1
mg/
kg/
day.
For
the
acute
assessment,
the
females
(
13
 
50
years)
subpopulation
generated
an
acute
DWLOC
of
approximately
30,000
ppb.
The
acute
EEC
of
70
ppb
is
considerably
less
than
30,000
ppb.
For
the
chronic
assessment,
the
children
1
and
2
years
old
subpopulation
generated
the
lowest
chronic
DWLOC
of
approximately
320
ppb.
Thus,
the
chronic
DWLOC
of
320
ppb
is
considerably
higher
than
the
chronic
EEC
of
33
ppb.
Syngenta
has
considered
the
potential
aggregate
exposure
from
food,
water
and
nonoccupational
exposure
routes
and
concluded
that
aggregate
exposure
is
not
expected
to
exceed
100%
of
the
cRfD
and
that
there
is
a
reasonable
certainty
that
no
harm
will
result
to
infants
and
children
from
the
aggregate
exposure
to
fludioxonil.

F.
International
Tolerances
There
are
no
Codex
maximum
residue
levels
established
for
fludioxonil.
[
FR
Doc.
03
 
7977
Filed
4
 
1
 
03;
8:
45
am]

BILLING
CODE
6560
 
50
 
S
ENVIRONMENTAL
PROTECTION
AGENCY
[
OPP
 
2002
 
0352;
FRL
 
7286
 
2]

Experimental
Use
Permit;
Receipt
of
Application
AGENCY:
Environmental
Protection
Agency
(
EPA).
ACTION:
Notice.

SUMMARY:
This
notice
announces
receipt
of
an
application
524
 
EUP
 
OA
from
Monsanto
Company
requesting
an
experimental
use
permit
(
EUP)
for
the
Bacillus
thuringiensis
Cry3Bb1
protein
and
the
genetic
material
necessary
for
its
production
(
vector
ZMIR39)
in
corn.
The
Agency
has
determined
that
the
application
may
be
of
regional
and
national
significance.
Therefore,
in
accordance
with
40
CFR
172.11(
a),
the
Agency
is
soliciting
comments
on
this
application.

DATES:
Comments,
identified
by
docket
ID
number
OPP
 
2002
 
0352,
must
be
received
on
or
before
May
2,
2003.
ADDRESSES:
Comments
may
be
submitted
electronically,
by
mail,
or
through
hand
delivery/
courier.
Follow
the
detailed
instructions
as
provided
in
Unit
I.
of
the
SUPPLEMENTARY
INFORMATION.

FOR
FURTHER
INFORMATION
CONTACT:
Mike
Mendelsohn,
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
 
8715;
e­
mail
address:
mendelsohn.
mike@
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
to
those
persons
who
are
interested
in
agricultural
biotechnology
or
may
be
required
to
conduct
testing
of
chemical
substances
under
the
Federal
Food,
Drug,
and
Cosmetic
Act
(
FFDCA)
or
the
Federal
Insecticide,
Fungicide,
and
Rodenticide
Act
(
FIFRA).
Since
other
entities
may
also
be
interested,
the
Agency
has
not
attempted
to
describe
all
the
specific
entities
that
may
be
affected
by
this
action.
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
 
2002
 
0352.
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.
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
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16051
Federal
Register
/
Vol.
68,
No.
63
/
Wednesday,
April
2,
2003
/
Notices
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.
1.
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
 
2002
 
0352.
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
 
2002
 
0352.
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),
Office
of
Pesticide
Programs
(
OPP),
Environmental
Protection
Agency
(
7502C),
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC,
20460
 
0001,
Attention:
Docket
ID
Number
OPP
 
2002
 
0352.
3.
By
hand
delivery
or
courier.
Deliver
your
comments
to:
Public
Information
and
Records
Integrity
Branch
(
PIRIB),
Office
of
Pesticide
Programs
(
OPP),
Environmental
Protection
Agency,
Rm.
119,
Crystal
Mall
#
2,
1921
Jefferson
Davis
Hwy.,
Arlington,
VA,
Attention:
Docket
ID
Number
OPP
 
2002
 
0352.
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:

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16052
Federal
Register
/
Vol.
68,
No.
63
/
Wednesday,
April
2,
2003
/
Notices
1.
Explain
your
views
as
clearly
as
possible.
2.
Describe
any
assumptions
that
you
used.
3.
Provide
copies
of
any
technical
information
and/
or
data
you
used
that
support
your
views.
4.
If
you
estimate
potential
burden
or
costs,
explain
how
you
arrived
at
the
estimate
that
you
provide.
5.
Provide
specific
examples
to
illustrate
your
concerns.
6.
Offer
alternative
ways
to
improve
the
notice.
7.
Make
sure
to
submit
your
comments
by
the
deadline
in
this
document.
8.
To
ensure
proper
receipt
by
EPA,
be
sure
to
identify
the
docket
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.
Background
Monsanto
has
applied
to
test
Bacillus
thuringiensis
Cry3Bb1
protein
and
the
genetic
material
necessary
for
its
production
(
vector
ZMIR39)
in
corn
on
829
acres
in
2003
and
2,299
acres
in
2004
in
Alabama,
California,
Colorado,
Hawaii,
Illinois,
Indiana,
Iowa,
Kansas,
Kentucky,
Maryland,
Michigan,
Minnesota,
Mississippi,
Missouri,
Nebraska,
New
Mexico,
New
York,
North
Carolina,
Ohio,
Pennsylvania,
Puerto
Rico,
South
Dakota,
Tennessee,
Texas,
Virginia,
and
Wisconsin
for
breeding
and
observation
nursery,
inbred
seed
increase
production,
line
per
se
and
hybrid
yield,
insect
efficacy,
product
characterization
and
performance/
labeling,
insect
resistance
management,
non­
target
organism
and
benefit,
seed
treatment,
swine
growth
and
feed
efficiency,
dairy
cattle
feed
efficiency,
beef
cattle
growth
and
feed
efficiency,
and
cattle
grazing
feed
efficiency
trials.
This
plant­
incorporated
protectant
is
being
tested
against
corn
rootworm
species.
The
tolerance
exemption
under
40
CFR
180.1214
applies
to
this
plant­
incorporated
protectant.
A
tolerance
exemption
in
40
CFR
part
180
applies
to
the
associated
marker
gene
and
its
product,
which
the
Agency
considers
a
plant­
incorporated
protectant
inert
ingredient.

III.
What
Action
is
the
Agency
Taking?

Following
the
review
of
the
Monsanto
Company
application
and
any
comments
and
data
received
in
response
to
this
notice,
EPA
will
decide
whether
to
issue
or
deny
the
EUP
request
for
this
EUP
program,
and
if
issued,
the
conditions
under
which
it
is
to
be
conducted.
Any
issuance
of
an
EUP
will
be
announced
in
the
Federal
Register.
IV.
What
is
the
Agency's
Authority
for
Taking
this
Action?

The
specific
legal
authority
for
EPA
to
take
this
action
is
under
FIFRA
section
5.

List
of
Subjects
Environmental
protection,
Experimental
use
permits.

Dated:
March
21,
2003.
Janet
L.
Andersen,
Director,
Biopesticides
and
Pollution
Prevention
Division,
Office
of
Pesticide
Programs.

[
FR
Doc.
03
 
7975
Filed
4
 
1
 
03;
8:
45
am]

BILLING
CODE
6560
 
50
 
S
FEDERAL
COMMUNICATIONS
COMMISSION
Notice
of
Public
Information
Collection(
s)
Being
Reviewed
by
the
Federal
Communications
Commission,
Comments
Requested
March
27,
2003.
SUMMARY:
The
Federal
Communications
Commission,
as
part
of
its
continuing
effort
to
reduce
paperwork
burden
invites
the
general
public
and
other
Federal
agencies
to
take
this
opportunity
to
comment
on
the
following
information
collection(
s),
as
required
by
the
Paperwork
Reduction
Act
of
1995,
Public
Law
104
 
13.
An
agency
may
not
conduct
or
sponsor
a
collection
of
information
unless
it
displays
a
currently
valid
control
number.
No
person
shall
be
subject
to
any
penalty
for
failing
to
comply
with
a
collection
of
information
subject
to
the
Paperwork
Reduction
Act
(
PRA)
that
does
not
display
a
valid
control
number.
Comments
are
requested
concerning
(
a)
whether
the
proposed
collection
of
information
is
necessary
for
the
proper
performance
of
the
functions
of
the
Commission,
including
whether
the
information
shall
have
practical
utility;
(
b)
the
accuracy
of
the
Commission's
burden
estimate;
(
c)
ways
to
enhance
the
quality,
utility,
and
clarity
of
the
information
collected;
and
(
d)
ways
to
minimize
the
burden
of
the
collection
of
information
on
the
respondents,
including
the
use
of
automated
collection
techniques
or
other
forms
of
information
technology.
DATES:
Written
comments
should
be
submitted
on
or
before
June
2,
2003.
If
you
anticipate
that
you
will
be
submitting
comments,
but
find
it
difficult
to
do
so
within
the
period
of
time
allowed
by
this
notice,
you
should
advise
the
contact
listed
below
as
soon
as
possible.
ADDRESSES:
Direct
all
comments
to
Judith
B.
Herman,
Federal
Communications
Commission,
Room
1
 
C804,
445
12th
Street,
SW.,
Washington,
DC
20554
or
via
the
Internet
to
Judith­
B.
Herman@
fcc.
gov.

FOR
FURTHER
INFORMATION
CONTACT:
For
additional
information
or
copies
of
the
information
collection(
s),
contact
Judith
B.
Herman
at
202
 
418
 
0214
or
via
the
Internet
at
Judith­
B.
Herman@
fcc.
gov.

SUPPLEMENTARY
INFORMATION:
OMB
Control
No.:
3060
 
0168.
Title:
Section
43.43,
Reports
of
Proposed
Changes
in
Depreciation
Rates.
Form
No.:
N/
A.
Type
of
Review:
Extension
of
a
currently
approved
collection.
Respondents:
Business
or
other
forprofit
Number
of
Respondents:
10.
Estimated
Time
Per
Response:
6,000
hours.
Frequency
of
Response:
On
occasion
reporting
requirement
and
recordkeeping
requirement.
Total
Annual
Burden:
40,000
hours.
Total
Annual
Cost:
N/
A.
Needs
and
Uses:
The
Commission
streamlined
its
depreciation
prescription
process
by
permitting
summary
filings
and
eliminating
the
prescription
of
depreciation
rates
for
incumbent
Local
Exchange
Carrier's
(
LECs),
expanding
the
prescribed
range
for
the
digital
switching
plant
account,
and
eliminating
the
theoretical
reserve
study
requirement
for
mid­
sized
incumbent
LECs.
The
Commission
also
established
a
waiver
process
whereby
price
cap
incumbent
LECs
can
free
themselves
of
depreciation
regulation.
The
Commission
is
submitting
this
information
collection
to
OMB
without
any
changes
since
the
last
approval
and
is
seeking
a
three
year
clearance.
OMB
Control
No.:
3060
 
0233.
Title:
Part
36,
Separations.
Form
No.:
N/
A.
Type
of
Review:
Extension
of
a
currently
approved
collection.
Respondents:
Business
or
other
forprofit
and
state,
local
or
tribal
government.
Number
of
Respondents:
1,500
respondents;
5,600
responses.
Estimated
Time
Per
Response:
2
 
22
hours.
Frequency
of
Response:
On
occasion,
annual
and
quarterly
reporting
requirements
and
third
party
disclosure
requirement.
Total
Annual
Burden:
157,125
hours.
Total
Annual
Cost:
N/
A.
Needs
and
Uses:
In
order
to
all
determination
of
the
study
areas
that
are
entitled
to
an
expense
adjustment,
and
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