34962
Federal
Register
/
Vol.
68,
No.
112
/
Wednesday,
June
11,
2003
/
Notices
mammalian
toxins
or
human
allergens;
is
not
derived
from
a
source
known
to
produce
allergens;
is
not
targeted
to
a
cellular
pathway
for
glycosylation
in
the
plant;
and
is
rapidly
degraded
upon
exposure
to
simulated
gastric
and
intestinal.
The
genetic
material
necessary
for
the
production
of
APH4
as
an
inert
ingredient
are
the
nucleic
acids
(
DNA)
which
comprise
genetic
material
encoding
this
protein
and
its
regulatory
regions.
``
Regulatory
regions''
are
the
genetic
material
that
control
the
expression
of
the
genetic
material
encoding
the
protein,
such
as
promoters,
terminators,
and
enhancers.
DNA
is
common
to
all
forms
of
plant
and
animal
life
and
the
Agency
has
previously
stated
that
they
are
not
aware
of
an
instance
where
these
nucleic
acids
have
been
associated
with
toxic
effects
related
to
their
consumption
as
a
component
of
food.
These
ubiquitous
nucleic
acids,
as
they
appear
in
the
subject
inert
ingredient,
have
been
adequately
characterized.
Therefore,
no
mammalian
toxicity
is
anticipated
from
dietary
exposure
to
the
genetic
material
necessary
for
the
production
of
the
subject
inert
plant
pesticidal
ingredient.

D.
Aggregate
Exposure
1.
Dietary
exposure
 
i.
Food.
Derivatives
of
cottonseed
(
e.
g.,
refined
cottonseed
oil)
and
fiber
(
e.
g.,
linters,
which
are
essentially
100%
cellulose)
are
used
in
some
food
products.
However,
APH4
was
not
detected
in
most
of
the
samples
of
COT102­
derived
cottonseed
analyzed
or
any
of
the
cotton
fiber
samples
analyzed.
In
the
few
cottonseed
samples
in
which
APH4
was
detectable,
the
quantities
were
below
the
limit
of
quantification
(<
137
ng
APH4/
g
fresh
wt;
<
150
ng
APH4/
g
dry
wt).
It
is
expected
that
any
trace
quantities
of
APH4
in
cottonseed
will
be
eliminated
by
standard
seed
processing
methods.
As
demonstrated
by
the
analysis
of
cottonseed
products
for
VIP3A
protein,
no
VIP3A
was
detected
in
refined
cottonseed
oil
from
COT102­
derived
plants,
despite
the
presence
of
ca.
3
micrograms
VIP3A/
g
seed
(
fresh
or
dry
wt.).
Additionally,
no
protein
of
any
kind
was
detected
in
the
same
sample
of
refined
cottonseed
oil.
It
can
be
concluded
that
APH4,
as
produced
in
COT102­
derived
cotton
plants,
does
not
pose
a
risk
of
becoming
allergenic
via
food,
because
there
will
be
no
exposure
via
food.
Additionally,
the
APH4
protein
shows
no
amino
acid
sequence
homology
to
known
allergens;
is
not
derived
from
a
source
known
to
produce
allergens;
is
not
targeted
to
a
cellular
pathway
for
glycosylation
in
the
plant;
and
is
rapidly
degraded
upon
exposure
to
simulated
gastric
and
intestinal.
ii.
Drinking
water.
No
exposure
to
the
APH4
and
the
genetic
material
necessary
for
its
production
as
an
inert
ingredient
via
drinking
water
are
expected.
The
protein
is
incorporated
into
the
plant
and
will
therefore
not
be
available
to
drinking
water
sources.
2.
Non­
dietary
exposure.
Non­
dietary
exposure
is
not
anticipated,
due
to
the
proposed
use
pattern
of
the
product.
Exposure
via
dermal
or
inhalation
routes
is
unlikely
because
the
inert
ingredient
is
contained
within
plant
cells.
However,
if
exposure
were
to
occur
by
non­
dietary
routes,
no
risk
would
be
expected
because
the
APH4
protein
is
not
toxic
to
mammals.

E.
Cumulative
Exposure
Because
there
is
no
indication
of
mammalian
toxicity
to
the
APH4
protein,
it
is
reasonable
to
conclude
that
there
are
no
cumulative
effects
for
this
inert
ingredient.

F.
Safety
Determination
1.
U.
S.
population.
The
lack
of
mammalian
toxicity
at
high
levels
of
exposure
to
the
APH4
protein
demonstrates
the
safety
of
the
product
at
levels
well
above
possible
maximum
exposure
levels
anticipated
via
consumption
of
processed
food
products
produced
from
VIP3A
cotton.
Moreover,
little
to
no
human
dietary
exposure
to
APH4
protein
is
expected
to
occur
via
VIP3A
cotton.
Due
to
the
lack
of
toxicity
of
the
APH4
protein
and
its
very
low
potential
for
allergenicity,
dietary
exposure
is
not
anticipated
to
pose
any
harm
for
the
U.
S.
population.
No
special
safety
provisions
are
applicable
for
consumption
patterns
or
for
any
population
sub­
groups.
2.
Infants
and
children.
Syngenta
has
evaluated
the
acute
toxicity
data
generated
on
APH4,
the
lack
of
homology
to
known
allergens
or
toxins,
and
the
limited
exposure
to
this
protein
based
on
the
residue
profile
and
limited
number
of
food/
feed
products
resulting
from
cotton
and
has
determined
that
there
is
ample
evidence
to
indicate
a
reasonable
certainty
of
no
harm
to
infants
and
children
as
a
result
of
the
use
of
this
product.

G.
Effects
on
the
Immune
and
Endocrine
Systems
The
inert
ingredient
APH4
is
a
protein,
derived
from
sources
that
are
not
known
to
exert
an
influence
on
the
endocrine
or
immune
systems.

H.
Existing
Tolerances
The
registrant
is
not
aware
of
any
known
existing
tolerances
or
exemptions
for
APH4
and
the
genetic
material
necessary
for
its
production
as
an
inert
ingredient.

I.
International
Tolerances
The
registrant
is
not
aware
that
any
Codex
maximum
residue
levels
exist
for
the
APH4
protein
and
the
genetic
material
necessary
for
its
production.

J.
Reference
1.
Sjoblad,
R.
D.,
J.
T.
McClintock
and
R.
Engler
(
1992)
Toxicological
considerations
for
protein
components
of
biological
pesticide
products.
Regulatory
Toxicol.
Pharmacol.
15:
3
 
9.

[
FR
Doc
03
 
14327
Filed
6
 
10
 
03;
8:
45
am]

BILLING
CODE
6560
 
50
 
S
ENVIRONMENTAL
PROTECTION
AGENCY
[
OPP
 
2003
 
0187;
FRL
 
7311
 
8]

Experimental
Use
Permit;
Receipt
of
Application
for
Use
of
Aspergillus
Flavus
NRRL
21882
AGENCY:
Environmental
Protection
Agency
(
EPA).
ACTION:
Notice.

SUMMARY:
This
notice
announces
receipt
of
an
application
75624­
EUP­
R
from
Circle
One
Global,
Inc.
requesting
an
experimental
use
permit
(
EUP)
for
the
Aspergillus
flavus
NRRL
21882.
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
 
2003
 
0187,
must
be
received
on
or
before
July
11,
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:
Shanaz
Bacchus,
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
 
8097;
e­
mail
address:
bacchus.
shanaz@
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
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34963
Federal
Register
/
Vol.
68,
No.
112
/
Wednesday,
June
11,
2003
/
Notices
of
interest
to
an
agricultural
producer,
food
manufacturer,
pesticide
manufacturer,
or
a
person
who
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
 
2003
 
0187.
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
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
 
2003
 
0187.
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
 
0187.
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
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Vol.
68,
No.
112
/
Wednesday,
June
11,
2003
/
Notices
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
 
0187.
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
 
0187.
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.
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
Circle
One
Global,
Inc.,
One
Arthur
St.,
P.
O.
Box
28,
Shellman,
GA
39886
 
0028,
has
applied
for
an
EUP
for
field
testing
of
a
new
end­
use
product
of
a
microbial
pesticide
containing
the
active
ingredient,
Aspergillus
flavus
NRRL
21882,
in
a
non­
crop
destruct
program.
The
product
is
to
be
ground
applied
and
is
a
granular
formulation.
At
the
proposed
use
rate
of
20
lbs/
acre,
the
equivalent
amount
of
active
ingredient
applied
is
only
0.002
lbs/
acre.
The
requested
EUP
is
for
a
total
of
5,000
acres
to
be
treated
for
a
total
application
of
10
lbs
of
the
active
ingredient.
Concurrent
with
this
application,
the
applicant
filed
a
pesticide
petition
number
3G6559
for
a
temporary
exemption
from
tolerance
for
residues
of
Aspergillus
flavus
NRRL
21882
in/
on
the
food/
feed
commodity
peanut.
Application
of
the
pesticide
is
proposed
to
reduce
aflatoxin­
producing
colonies
of
Aspergillus
flavus
on
the
crop
and
in
the
soil
by
competitive
displacement.
Testing
of
100
lbs
of
the
active
ingredient
will
occur
in
three
States:
Alabama,
Florida,
and
Georgia.

III.
What
Action
is
the
Agency
Taking?
Following
the
review
of
the
Circle
One
Global,
Inc.
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
Agency's
authority
for
taking
this
action
is
under
FIFRA
section
5
List
of
Subjects
Environmental
protection,
Experimental
use
permits.
Dated:
June
2,
2003.
Janet
L.
Andersen,
Director,
Biopesticides
and
Pollution
Prevention
Division,
Office
of
Pesticide
Programs.

[
FR
Doc.
03
 
14462
Filed
6
 
10
 
03;
8:
45
am]

BILLING
CODE
6560
 
50
 
S
ENVIRONMENTAL
PROTECTION
AGENCY
[
FRL
 
7510
 
9]

Horseshoe
Bend
Dump
Superfund
Site;
Notice
of
Proposed
Settlement
AGENCY:
Environmental
Protection
Agency.
ACTION:
Notice
of
proposed
settlement.

SUMMARY:
Under
section
122(
h)
of
the
Comprehensive
Environmental
Response,
Compensation
and
Liability
Act
(
CERCLA),
the
Environmental
Protection
Agency
(
EPA)
has
offered
a
settlement
at
the
Horseshoe
Bend
Dump
Superfund
Site
in
Lawrenceburg,
Lawrence
County,
Tennessee
under
a
CERCLA
122(
h)
Agreement
for
recovery
of
Response
Costs
to
settle
claims
for
past
costs
at
the
Site.
The
two
(
2)
parties
to
the
agreement
have
returned
signature
pages
accepting
EPA's
settlement
offer.
EPA
will
consider
public
comments
on
the
proposed
settlement
until
July
11,
2003.
EPA
may
withdraw
from
or
modify
the
proposed
settlement
should
such
comments
disclose
facts
or
considerations
which
indicate
the
proposed
settlement
is
inappropriate,
improper
or
inadequate.
Copies
of
the
proposed
settlement
are
available
from:
Ms.
Paula
V.
Batchelor,
U.
S.
Environmental
Protection
Agency,
Region
4,
CERCLA
Program
Services
Branch,
61
Forsyth
Street,
SW.,
Atlanta,
Georgia
30303,
(
404)
562
 
8887.
Written
Comments
made
be
submitted
to
Ms.
Paula
V.
Batchelor
at
the
above
address
within
30
days
of
the
date
of
publication.

Dated:
May
21,
2003.
Archie
Lee,
Chief,
CERCLA
Program
Services
Branch,
Waste
Management
Division.
[
FR
Doc.
03
 
14747
Filed
6
 
10
 
03;
8:
45
am]

BILLING
CODE
6560
 
50
 
P
EQUAL
EMPLOYMENT
OPPORTUNITY
COMMISSION
Agency
Information
Collection
Activities:
Proposed
Collection;
Comments
Request
AGENCY:
Equal
Employment
Opportunity
Commission
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23:
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2003
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