Document ID: EPA-HQ-OPPT-2003-0016-0001
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: 2003-05-21T04:00Z

27797
Federal
Register
/
Vol.
68,
No.
98
/
Wednesday,
May
21,
2003
/
Notices
Number
to
be
surveyed
annually
Total
Hours
Burden
Rate
per
hour
($)
Total
Cost
(
D=
B*
C)

(
A)
(
B)
(
C)
(
D)

1,000
Parents
..............................................................................................................................
250
$
20.29
$
5,072.50
Total
(
Annual)
.......................................................................................................................
3,750
........................
$
23,512.50
ICR
Total
(
3
years)
...............................................................................................................
11,250
........................
$
70,537.50
The
contractor
(
Boston
University
Medical
Center)
will
assist
EPA
in
data
collection
and
analysis.
EPA
has
contracted
for
a
total
of
400
professional
hours.
At
an
average
rate
of
$
100
per
hour,
the
total
cost
for
the
contractor
is
$
40,000
annually.
Agency
burden
to
manage
this
contract
is
estimated
at
4
hours/
month
or
48
hours
annually.
The
cost
of
this
labor
will
be
calculated
based
on
a
GS
12
Step
5
pay
level
($
44.75/
hour
using
the
salary
associated
with
this
grade
and
step,
multiplied
by
a
benefits
factor
of
1.616).
Total
hours
(
48)
multiplied
by
$
44.75
per
hour
amounts
to
a
total
agency
labor
cost
of
$
2,196/
per
annum.
Burden
means
the
total
time,
effort,
or
financial
resources
expended
by
persons
to
generate,
maintain,
retain,
or
disclose
or
provide
information
to
or
for
a
Federal
agency.
This
includes
collecting,
validating,
and
verifying
information,
processing
and
maintaining
information,
and
disclosing
and
providing
information;
adjust
the
existing
ways
to
comply
with
any
previously
applicable
instructions
and
requirements;
train
personnel
to
be
able
to
respond
to
a
collection
of
information;
search
data
sources;
complete
and
review
the
collection
of
information;
and
transmit
or
otherwise
disclose
the
information.

Dated:
May
6,
2003.
Drusilla
Hufford,
Director,
Global
Programs
Division.
[
FR
Doc.
03
 
12763
Filed
5
 
20
 
03;
8:
45
am]

BILLING
CODE
6560
 
50
 
P
ENVIRONMENTAL
PROTECTION
AGENCY
[
OPPT
 
2003
 
0016;
FRL
 
7304
 
9]

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
of
public
meeting.

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
June
5
 
6,
2003.
This
meeting,
as
with
all
EDMVS
meetings,
is
open
to
the
public.
Seating
is
on
a
first­
come
basis.
DATES:
The
meeting
will
be
held
on
Thursday,
June
5,
2003,
from
9
a.
m.
to
5
p.
m.,
and
Friday,
June
6,
2003,
from
8:
30
a.
m.
to
3
p.
m.
eastern
daylight
time.
The
telephone
number
at
RESOLVE
is
(
202)
944
 
2300.
Individuals
requiring
special
accommodations
at
the
meeting,
including
wheelchair
access,
should
contact
Jane
Smith
at
the
address
listed
under
FOR
FURTHER
INFORMATION
CONTACT
at
least
5
business
days
prior
to
the
meeting,
so
appropriate
arrangements
can
be
made.
ADDRESSES:
The
meeting
will
be
held
at
RESOLVE,
1255
23rd
St.,
NW.,
Suite
275,
Washington,
DC.
Requests
and
comments
may
be
submitted
electronically,
by
telephone,
fax,
or
through
hand
delivery/
courier.
Follow
the
detailed
instructions
as
provided
in
Unit
I.
C.
of
the
SUPPLEMENTARY
INFORMATION.
FOR
FURTHER
INFORMATION
CONTACT:
Jane
Smith,
Designated
Federal
Official
for
the
EDMVS,
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
 
8483;
or
e­
mail
address:
smith.
jane­
scott@
epa.
gov.
SUPPLEMENTARY
INFORMATION:

I.
General
Information
A.
Does
this
Notice
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
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
 
0016.
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.
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.
You
may
also
go
directly
to
the
``
Federal
Register''
listings
at
http:/
/
www.
epa.
gov/
fedrgstr/.
An
electronic
version
of
the
public
docket
is
available
through
EPA's
electronic
docket
and
comment
system,
EPA
Dockets.
You
may
use
EPA
Dockets
at
http://
www.
epa.
gov/
edocket
to
view
public
comments,
access
the
index
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2003
15:
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20,
2003
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21MYN1
RECEIVED
OPPT
NCIC
2003
MAY21
8:
09AM
OPPT­
2003­
0016­
0001
27798
Federal
Register
/
Vol.
68,
No.
98
/
Wednesday,
May
21,
2003
/
Notices
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
docket
ID
number
OPPT
 
2003
 
0016.
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.
I.

C.
How
Can
I
Request
to
Participate
in
the
Meeting?
You
may
submit
a
request
to
participate
in
the
meeting
through
electronic
mail,
telephone,
fax,
or
in
person.
EPA
would
normally
accept
requests
by
mail,
but
in
this
time
of
delays
in
delivery
of
government
mail
due
to
health
and
security
concerns,
EPA
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
May
27,
2003.
To
ensure
proper
receipt
by
EPA,
it
is
imperative
that
you
identify
docket
ID
number
OPPT
 
2003
 
0016
in
the
subject
line
on
the
first
page
of
your
request.
1.
Electronically.
You
may
submit
your
request
to
participate
electronically.
Do
not
submit
any
information
electronically
that
you
consider
to
be
CBI.
Use
WordPerfect
6.1/
8.0
or
ASCII
file
format
and
avoid
the
use
of
special
characters
and
any
form
of
encryption.
i.
EPA
Docket.
You
may
use
EPA's
electronic
public
docket
to
submit
a
request
to
participate
in
this
meeting.
Go
to
EPA
Dockets
at
http://
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
 
0016.
ii.
E­
mail.
Request
to
participate
may
be
sent
by
e­
mail
to
the
person
listed
in
FOR
FURTHER
INFORMATION
CONTACT,
or
directly
to
the
docket
at
oppt.
ncic@
epa.
gov,
Attention:
Docket
ID
Number
OPPT
 
2003
 
0016.
2.
Telephone
or
fax.
Send
your
request
to
participate
to
the
individual
identified
in
FOR
FURTHER
INFORMATION
CONTACT.

D.
How
and
to
Whom
Do
I
Submit
Comments?
In
accordance
with
the
Federal
Advisory
Committee
Act
(
FACA),
the
public
is
encouraged
to
submit
written
comments
on
the
topic
of
this
meeting.
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.
You
may
submit
comments
electronically
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.
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.
E.
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
OPPT
 
2003
 
0016.
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
oppt.
ncic@
epa.
gov,
Attention:
Docket
ID
Number
OPPT
 
2003
 
0016.
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
email
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
by
courier
or
package
service,
such
as
Federal
Express
to
the
address
identified
in
Unit
I.
D.
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
hand
delivery
or
courier.
Deliver
your
comments
to:
OPPT
Document
Control
Office
(
DCO)
in
EPA
East
Bldg.,
Rm.
6428,
1201
Constitution
Ave.,
NW.,
Washington,
DC.
Attention:
Docket
ID
Number
OPPT
 
2003
 
0016.
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.

E.
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
technical
person
listed
under
FOR
FURTHER
INFORMATION
CONTACT.

II.
Background
In
1996,
through
enactment
of
the
Food
Quality
Protection
Act,
which
VerDate
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Federal
Register
/
Vol.
68,
No.
98
/
Wednesday,
May
21,
2003
/
Notices
amended
the
Federal
Food,
Drug,
and
Cosmetic
Act,
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
the
Federal
Advisory
Committee
Act
(
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
I
screens)
and
tests
(
Tier
II
tests)
for
determining
whether
a
chemical
substance
may
have
an
effect
in
humans
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
Organization
for
Economic
Cooperation
and
Development's
(
OECD)
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
formed
the
Endocrine
Disruptor
Methods
Validation
Subcommittee
(
EDMVS)
of
the
National
Advisory
Council
for
Environmental
Policy
and
Technology
(
NACEPT).
EDMVS
provides
independent
advice
and
counsel
to
the
Agency
through
NACEPT,
on
scientific
and
technical
issues
related
to
validation
of
the
EDSP
Tier
I
screens
and
Tier
II
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
six
meetings
since
its
establishment
in
September
2001.
The
objectives
of
the
first
meeting,
which
was
held
in
October
2001,
(
docket
control
number
OPPT
 
42212D)
were
for
EPA
to
provide:
1.
An
overview
of
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.
The
objectives
of
the
December
2001
meeting
(
docket
control
number
OPPT
 
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
one­
generation
study
design.
The
objectives
of
the
March
2002
meeting
(
docket
control
number
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.
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
I
screening
assays.
8.
The
current
efforts
related
to
evaluating
the
relevance
of
animal
data
to
human
health.
9.
EPA's
approach
to
addressing
low
dose
issues.
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.
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
PTU
special
study.
 
An
amphibian
metamorphosis
detailed
review
paper.
 
An
invertebrate
detailed
review
paper.
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
II
fish
life
cycle
assay
detailed
review
paper.

III.
Meeting
Objectives
for
the
June
5
 
6,
2003
Meeting
The
objectives
of
the
June
5
 
6,
2003
(
docket
ID
number
OPPT
 
2003
 
0016)
are
for
EDMVS
to
provide
input
and
advice
on:
1.
The
Tier
II
Mammalian
2­
generation
special
study
on
the
onegeneration
extension
results.
2.
The
Tier
I
steroidogenesis
(
sliced
testes)
study
results.
3.
To
provide
the
status
of
the
Tier
I
study
results
of
the
aromatase
placental
tissue
study.
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
system,
Endocrine
disruptors,
Endocrine
disruptor
screening
program.

Dated:
May
9,
2003.
Joseph
Merenda,
Director,
Office
of
Science
Coordination
and
Policy,
Office
of
Prevention,
Pesticides
and
Toxic
Substances.
[
FR
Doc.
03
 
12484
Filed
5
 
20
 
03;
8:
45
am]

BILLING
CODE
6560
 
50
 
S
ENVIRONMENTAL
PROTECTION
AGENCY
[
OPP
 
2003
 
0142;
FRL
 
7308
 
4]

Fenhexamid;
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
VerDate
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31>
2003
15:
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20,
2003
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