Document ID: EPA-HQ-OPPT-2003-0016-0021
Agency: epa
Document Type: Notice
Title: Endocrine Disruptor Screening Program; Endocrine Disruptor Methods Validation Subcommittee under the National Advisory Council for Environmental Policy and Technology; Request for Nominations for Membership
Posted Date: 2003-06-16T04:00Z

32482
Federal
Register
/
Vol.
68,
No.
104
/
Friday,
May
30,
2003
/
Notices
20426,
in
accordance
with
Rules
211
and
214
of
the
Commission's
Rules
of
Practice
and
Procedure
(
18
CFR
385.211
and
385.214).
Protests
will
be
considered
by
the
Commission
in
determining
the
appropriate
action
to
be
taken,
but
will
not
serve
to
make
protestants
parties
to
the
proceeding.
Any
person
wishing
to
become
a
party
must
file
a
motion
to
intervene.
All
such
motions
or
protests
should
be
filed
on
or
before
the
comment
date,
and,
to
the
extent
applicable,
must
be
served
on
the
applicant
and
on
any
other
person
designated
on
the
official
service
list.
This
filing
is
available
for
review
at
the
Commission
or
may
be
viewed
on
the
Commission's
Web
site
at
http://
www.
ferc.
gov
,
using
the
``
FERRIS''
link.
Enter
the
docket
number
excluding
the
last
three
digits
in
the
docket
number
field
to
access
the
document.
For
assistance,
contact
FERC
Online
Support
at
FERCOnlineSupport@
ferc.
gov
or
tollfree
at
(
866)
208
 
3676,
or
for
TTY,
contact
(
202)
502
 
8659.
Protests
and
interventions
may
be
filed
electronically
via
the
Internet
in
lieu
of
paper;
see
18
CFR
385.2001(
a)(
1)(
iii)
and
the
instructions
on
the
Commission's
Web
site
under
the
``
e­
Filing''
link.
The
Commission
strongly
encourages
electronic
filings.

Magalie
R.
Salas,
Secretary.
[
FR
Doc.
03
 
13515
Filed
5
 
29
 
03;
8:
45
am]

BILLING
CODE
6717
 
01
 
P
DEPARTMENT
OF
ENERGY
Federal
Energy
Regulatory
Commission
Notice
of
Intent
To
File
an
Application
for
a
New
License
May
22,
2003.
a.
Type
of
Filing:
Notice
of
Intent
to
File
An
Application
for
a
New
License.
b.
Project
No.:
906.
c.
Date
Filed:
May
19,
2003.
d.
Submitted
By:
Virginia
Electric
and
Power
Company,
d.
b.
a.
Virginia
Dominion
Power
 
current
licensee.
e.
Name
of
Project:
Cushaw
Hydroelectric
Project.
f.
Location:
On
the
James
River
in
Amherst
County,
Virginia.
The
project
occupies
federal
land
within
the
Jefferson
National
Forest.
g.
Filed
Pursuant
to:
Section
15
of
the
Federal
Power
Act.
h.
Licensee
Contact:
James
Thornton,
Dominion
Virginia
Power,
(
Manager
for
Licensee),
Innsbrook
Technical
Center,
1
NE.,
5000
Dominion
Boulevard,
Glen
Allen,
VA
23060,
(
804)
273
 
3257.
i.
FERC
Contact:
Janet
Hutzel,
janet.
hutzel@
ferc.
com,
(
202)
502
 
8675.
j.
Effective
date
of
current
license:
September
1,
1980.
k.
Expiration
date
of
current
license:
June
15,
2008.
l.
Description
of
the
Project:
The
project
consists
of
the
following
existing
facilities:
(
1)
A
1,550­
foot­
long,
27­
foothigh
concrete
dam;
(
2)
a
138­
acre
reservoir;
(
3)
a
powerhouse
containing
five
turbine
generating
units
with
a
total
installed
capacity
of
7,500
kW;
and
(
4)
other
appurtenances.
m.
Each
application
for
a
new
license
and
any
competing
license
applications
must
be
filed
with
the
Commission
at
least
24
months
prior
to
the
expiration
of
the
existing
license.
All
applications
for
license
for
this
project
must
be
filed
by
June
15,
2006.
n.
A
copy
of
this
filing
is
available
for
review
at
the
Commission
in
the
Public
Reference
Room
or
may
be
viewed
on
the
Commission's
Web
site
at
http://
www.
ferc.
gov
using
the
``
FERRIS''
link.
Enter
the
docket
number
excluding
the
last
three
digits
in
the
docket
number
field
to
access
the
document.
For
assistance,
contact
FERC
Online
Support
at
FERCOnlineSupport@
ferc.
gov
or
tollfree
at
1
 
866
 
208
 
3676,
or
TTY
(
202)
502
 
8659.
A
copy
is
also
available
for
inspection
and
reproduction
at
the
address
in
item
h
above.
o.
Register
online
at
http://
www.
ferc.
gov/
esubscribenow.
htm
to
be
notified
via
email
of
new
filings
and
issuances
related
to
this
or
other
pending
projects.
For
assistance,
contact
FERC
Online
Support
as
shown
in
the
paragraph
above.

Magalie
R.
Salas,
Secretary.
[
FR
Doc.
03
 
13484
Filed
5
 
29
 
03;
8:
45
am]

BILLING
CODE
6717
 
01
 
P
ENVIRONMENTAL
PROTECTION
AGENCY
[
OPPT
 
2003
 
0011;
FRL
 
7305
 
4]

Endocrine
Disruptor
Screening
Program;
Endocrine
Disruptor
Methods
Validation
Subcommittee
under
the
National
Advisory
Council
for
Environmental
Policy
and
Technology;
Request
for
Nominations
for
Membership
AGENCY:
Environmental
Protection
Agency
(
EPA).
ACTIONS:
Notice.

SUMMARY:
As
mandated
by
the
Federal
Food,
Drug,
and
Cosmetic
Act
(
FFDCA),
amended
by
the
Food
Quality
Protection
Act
(
FQPA)
of
1996,
EPA
implemented
an
Endocrine
Disruptor
Screening
Program
(
EDSP).
As
part
of
the
EDSP,
the
Endocrine
Disruptor
Methods
Validation
Subcommittee
(
EDMVS)
was
established
in
2001,
is
a
Subcommittee
under
the
National
Advisory
Council
for
Environmental
Policy
and
Technology
(
NACEPT).
The
members
of
the
EDMVS
may
serve
up
to
three
2
 
year
terms.
This
notice
is
a
request
for
nominations
for
new
members
of
the
EDMVS
from
interested
organizations.
NACEPT
is
a
chartered
federal
advisory
committee
subject
to
the
provisions
of
the
Federal
Advisory
Committee
Act
(
FACA).
Through
NACEPT,
the
EDMVS
provides
technical
advice
and
recommendations
to
EPA
regarding
validation
of
the
Tier
I
screening
and
Tier
II
testing
methods
for
the
EDSP.
Background
information
regarding
the
Agency's
EDSP
and
the
EDMVS
are
discussed
in
Unit
III.
of
the
SUPPLEMENTARY
INFORMATION.
This
information
is
being
provided
to
allow
interested
persons
and
organizations
to
review
the
scope
of
activities
when
nominating
qualified
individuals
for
membership
on
the
EDMVS.
DATES:
Nominations,
identified
by
docket
ID
Number
OPPT
 
2003
 
0011
must
be
received
on
or
before
June
30,
2003.
ADDRESSES:
Nominations
for
membership
may
be
submitted
electronically,
by
fax,
or
through
hand
delivery/
courier.
Follow
the
detailed
instructions
as
provided
in
Unit
II.
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
20406
 
0001;
telephone
number:
(
202)
554
 
1404;
e­
mail
address:
TSCAHotline
epa.
gov.
For
technical
information
contact:
Jane
Smith,
Designated
Federal
Official
(
DFO)
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
(
202)
564
 
8483;
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.
You
may
be
interested
in
nominating
members
to
the
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2003­
0016­
0021
RECEIVED
OPPT
NCIC
2003
JUN16
10:
20AM
32483
Federal
Register
/
Vol.
68,
No.
104
/
Friday,
May
30,
2003
/
Notices
subcommittee
set
forth
in
this
notice
if
you
are
a
member
of
an
environmental/
public
interest
organization,
a
public
health
organization,
an
animal
welfare
organization,
academia,
or
Federal
agencies,
state,
local,
or
tribal
governments.
You
also
may
be
interested
in
activities
of
EPA's
EDSP
if
you
produce,
manufacture,
use,
consume,
work
with,
or
import
pesticides
or
other
chemicals.
To
determine
whether
you
or
your
business
may
have
an
interest
in
this
notice
you
should
carefully
examine
section
408(
p)
of
the
FFDCA,
as
amended
by
the
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
affected
by
this
action.
If
you
have
any
questions
regarding
the
applicability
of
this
action,
consult
the
technical
persons
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
 
0011.
This
official
public
docket
consists
of
this
Notice,
public
comments
regarding
this
Notice,
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
is
available
for
public
viewing
at
EPA's
Docket
Center,
Rm.
B102
­
Reading
Room,
EPA
West,
1301
Constitution
Ave.,
NW.,
Washington,
DC.
EPA's
Docket
Center
is
open
from
8:
30
a.
m.
to
4:
30
p.
m.,
Monday
through
Friday,
excluding
legal
holidays.
EPA's
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.
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
submit
nominations
and
comments
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
edocket
system,
select
``
search,''
then
key
in
the
appropriate
docket
ID
number
(
OPPT
 
2003
 
0011).
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.
You
may
access
this
Federal
Register
document
electronically
through
the
EPA
Internet
under
the
``
Federal
Register''
listings
at
http://
www.
epa.
gov/
fedrgstr/,
or
you
may
obtain
electronic
copies
of
this
document,
and
certain
other
related
documents
through
the
EDSP
Web
site
for
the
EDMVS
at
http://
www.
epa.
gov/
scipoly/
oscpendo/
edmvs.
htm.
3.
In
person.
The
Agency
has
established
an
administrative
record
for
the
EDMVS
under
docket
ID
number
OPPT
 
2003
 
0011.
The
public
version
of
the
administrative
record,
which
includes
printed,
paper
versions
of
any
electronic
comments
that
may
be
submitted
during
an
applicable
comment
period,
is
available
for
inspection
in
the
EPA
Docket
Center.
See
I.
B.
1.
for
docket
center
information.

II.
How
Can
I
Nominate
Potential
Members
to
the
Endocrine
Disruptor
Methods
Validation
Subcommittee?
You
may
nominate
technically
qualified
persons
for
membership
to
the
EDMVS
electronically,
by
fax
or
in
person/
courier
service.
A
technically
qualified
nominee
could
come
from
industry,
an
environmental/
public
interest
organization,
a
public
health
organization,
an
animal
welfare
organization,
academia
or
Federal
agencies,
State,
local
or
tribal
governments
or
any
other
group
knowledgeable
in
endocrine
disruption,
method
validation
or
related
topics.
Nominations
for
membership
may
be
submitted
by
individuals
or
on
behalf
of
organizations,
and
must
include
a
curriculum
vitae
of
the
nominee
detailing
his
or
her
specific
area
of
relevant
scientific
expertise.
(
Please
exclude
the
following
information
from
the
curriculum
vitae:
The
nominee's
social
security
number,
birth
date
and
place,
home
address,
and
telephone
number.)
Technically
qualified
persons
may
also
nominate
themselves.
Current
members
whose
terms
are
about
to
expire
may
be
renominated
or
selfnominate
as
their
time
and
interests
allow.
Current
members
being
renominated
will
be
evaluated
in
the
same
manner
as
newly
nominated
candidates.
Members
of
the
EDMVS
are
selected
by
EPA
taking
into
consideration
their
relevant
scientific
expertise
and
diversity
of
perspectives
on
mammalian,
ecological,
and
in
vitro
endocrine
disruptor
screening
and
testing
methods
and
procedures,
toxicity
test
methods
standardization
and
validation,
and
chemical
and
pesticide
regulatory
processes.
Members
will
be
appointed
for
2
years.
In
appointing
members,
EPA
will
seek
to
achieve
balanced
representation
from
among
the
following
sectors:
the
agrichemical
and
commodity
chemical
industries;
environmental/
public
interest
organizations;
public
health
organizations;
animal
welfare
organizations;
Federal
agencies;
State,
local
and
tribal
governments;
academia;
consumers,
and
the
public.
Nominations
must
be
received
by
EPA
on
or
before
June
30,
2003.
To
ensure
proper
receipt
by
EPA,
it
is
imperative
that
you
identify
docket
ID
number
OPPT
 
2003
 
0011
in
the
subject
line
on
the
first
page
of
your
submission.
Do
not
include
the
nominee's
private
information,
such
as,
social
security
number,
birth
date
and
place,
home
address,
and
telephone
number.
You
may
submit
your
nomination
electronically,
by
fax,
in
person,
or
by
courier.
We
normally
would
accept
requests
by
mail,
but
in
this
time
of
delays
in
delivery
of
Federal
government
mail
due
to
health
and
security
concerns,
we
cannot
assure
your
request
would
arrive
in
a
timely
manner.
1.
Electronically.
You
may
submit
your
nomination
electronically.
Do
not
submit
any
information
electronically
that
you
consider
to
be
CBI
or
information
protected
under
the
Privacy
Act.
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
nomination.
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
 
0011.
Please
see
Unit
I.
B.
1.
ii.
E­
mail.
Nominations
may
be
sent
by
e­
mail
to
the
technical
contact
listed
under
FOR
FURTHER
INFORMATION
CONTACT,
or
directly
to
the
docket
at
oppt.
ncic@
epa.
gov,
Attention:
Docket
ID
number
OPPT
 
2003
 
0011.
iii.
Disk
or
CD
ROM.
You
may
submit
nominations
on
a
disk
or
CD
ROM
by
courier
or
package
service,
such
as
Federal
Express,
to:
the
OPPT
Document
Control
Office
(
DCO)
in
EPA
East
Building
Room
6428,
1201
Constitution
Ave.,
NW.,
Washington,
DC,
Attention:
Docket
ID
number
OPPT
 
2003
 
0011.
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.
These
electronic
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Federal
Register
/
Vol.
68,
No.
104
/
Friday,
May
30,
2003
/
Notices
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.
Due
to
security
measures,
disks
and
CD
ROMs
risk
being
destroyed
when
handled
as
Federal
government
mail.
2.
By
fax.
Send
your
nomination(
s)
to
the
technical
contact
identified
under
FOR
FURTHER
INFORMATION
CONTACT.
3.
In
person
or
by
courier.
Deliver
your
nomination
to:
OPPT
Document
Control
Office
(
DCO).
See
Unit
II.
1.
iii.
for
Document
Control
Office
information.

III.
Background
A.
Action
EPA's
ongoing
implementation
of
EDSP
is
science­
driven,
and
supported
by
the
recommendations
and
comments
of
knowledgeable
scientists
and
stakeholders.
Information
on
the
EDMVS
meetings
to
date,
a
list
of
the
current
members
of
the
EDMVS,
and
other
EPA
EDSP­
related
information
are
available
at
http://
www.
epa.
gov/
scipoly/
oscpendo/
edmvs.
htm.
The
EDMVS
held
it's
initial
meeting
in
October
2001.
All
26
members
started
their
membership
with
that
meeting
and
25
of
the
original
members
remain
with
the
subcommittee.
In
October
2003,
25
of
the
current
members
will
have
served
their
initial
2
 
year
term
and
may
reapply
to
the
subcommittee
or
not,
as
time
and
responsibilities
may
dictate.
The
purpose
of
this
Federal
Register
notice
is
to
solicit
nominations
for
scientists
who
would
be
interested
in
serving
on
this
cutting
edge
subcommittee.
You
may
nominate
others
and
you
may
self­
nominate.
Qualifications
for
subcommittee
membership
are
discussed
in
Unit
II.
of
the
SUPPLEMENTARY
INFORMATION.
EPA
hopes
to
announce
its
selection
of
members
for
the
subcommittee's
third
and
fourth
years
by
September
2003.

B.
The
Purpose
of
the
Endocrine
Disruptor
Methods
Validation
Subcommittee
1.
Purpose
and
authority.
The
EDMVS
was
established
in
accordance
with
the
FACA
(
5
U.
S.
C.
app.
2
section
9(
c)).
The
EDMVS
is
a
subcommittee
of
EPA's
NACEPT.
The
purpose
of
the
EDMVS
is
to
assist
NACEPT
in
providing
advice
and
counsel
to
EPA
on
scientific
issues
associated
with
the
conduct
of
studies
necessary
for
validation
of
Tier
I
and
Tier
II
assays
for
EPA's
EDSP.
The
EDMVS
explores
issues
regarding:
The
development
and
choice
of
initial
protocols;
prevalidation
study
designs;
validation
study
designs;
the
integration
of
prevalidation,
and
validation
study
results
into
EDSP
Tier
I
and
Tier
II
methods
documents
suitable
for
external
peer
review.
All
EDMVS
recommendations
are
forwarded
to
the
Agency
through
NACEPT.
Taking
into
consideration
this
advice
and
recommendations,
EPA
will
manage
and
conduct
prevalidation
and
validation
laboratory
studies.
2.
Objective
and
scope
of
the
activity.
The
EDMVS
and
NACEPT
provide
a
forum
for
diverse
groups
of
individuals
representing
a
broad
range
of
interests
to
consult
with
and
make
recommendations
to
the
Agency
on
matters
relating
to
the
development,
optimization,
and
validation
of
endocrine
disruptor
screening
and
testing
methods.
The
subcommittee
will
analyze
issues,
review
data
and
protocols,
compile
information,
make
recommendations
to
the
Agency
through
NACEPT,
and
undertake
other
activities
necessary
to
meet
its
responsibilities.
The
complete
Mission
Statement
is
available
at:
http://
www.
epa.
gov/
scipoly/
oscpendo/
edmvs.
htm,
press
enter
and
page
down
to
``
EDMVS
Subcommittee
Mission
Statement.''
3.
Meetings.
The
EDMVS
may
hold
up
to
six
meetings
a
year.
These
meetings
generally
are
held
in
Washington,
DC
and
usually
last
for
2
 
3
days.
Meeting
materials
to
be
discussed
are
distributed
to
members
prior
to
the
meetings.
A
regular
employee
of
EPA
acts
as
the
DFO
and
will
be
present
or
represented
at
all
meetings.
All
EDMVS
meetings
are
called,
announced,
and
held
in
accordance
with
FACA
and
NACEPT
rules,
which
require
open
meetings
and
an
opportunity
for
interested
persons
to
file
comments
before
or
after
meetings,
or
to
make
statements
during
the
public
meetings
to
the
extent
time
permits.
The
date,
time,
location,
and
any
public
participation
instructions
for
each
meeting
are
announced
in
the
Federal
Register
at
least
15
days
before
the
meeting
date.
Each
meeting
is
conducted
in
accordance
with
an
agenda.
Meeting
information
and
the
agenda
are
posted
on
the
Agency's
web
site
as
soon
as
available.
To
date,
the
EDMVS
has
held
six,
meetings
starting
with
a
2
 
day
meeting
October
30
 
31,
2001.
Other
face­
to­
face
meetings
were
held;
December
10
 
12,
2001;
March
25
 
27,
2002;
and
July
23
 
24,
2002.
There
have
been
two
2
 
hour
teleconferences,
each
on
a
single
topic.
There
are
face­
to­
face
meetings
planned
for
June
5
 
6,
2003
and
August
19
 
21,
2003.
C.
Establishment
of
the
Endocrine
Disruptor
Screening
Program
The
complexity
of
the
scientific
and
regulatory
issues
surrounding
the
endocrine
disruptor
issue
led
EPA
to
seek
broad
expert
advice
and
counsel
beyond
the
Agency.
EPA
held
a
public
meeting
in
May
of
1996
requesting
advice
on
how
to
develop
a
scientifically
defensible,
pragmatic
approach
to
endocrine
disruptor
screening
and
testing.
The
stakeholder
feedback
indicated
that
a
broad
based
multi­
sector
stakeholder
committee
should
be
established
under
the
FACA.
Following
a
second
public
meeting
and
analysis
of
stakeholder
interests
(
Keystone
Center
Convening
Report),
the
Agency
chartered
the
Endocrine
Disruptor
Screening
and
Testing
Advisory
Committee
(
EDSTAC).
EDSTAC
was
charged
with
providing
advice
and
recommendations
to
the
Agency
regarding
a
strategy
for
testing
chemical
substances
to
determine
whether
they
may
have
an
effect
in
humans
similar
to
an
effect
produced
by
naturally
occurring
hormones.
EDSTAC
consisted
of
39
representatives
from
industry,
environmental
and
public
health
advocacy
groups,
state
government,
other
Federal
agencies,
and
academic
scientists.
Over
a
2
 
year
period,
EDSTAC
held
eight
meetings.
In
its
final
report
(
available
at
http://
www.
epa.
gov/
scipoly/
oscpendo/
history/
exesum14.
pdf),
EDSTAC
provided
71
consensus
recommendations
regarding
an
endocrine
disruptor
screening
program.
EPA's
EDSP
was
set
forth
in
a
notice
published
in
the
Federal
Register
of
August
11,
1998
(
63
FR
42852)
(
FRL
 
6021
 
3),
and
described
in
more
detail
in
a
proposed
statement
of
policy
published
in
the
Federal
Register
of
December
28,
1998
(
FR
67
79611)
(
FRL
 
7286
 
6).
The
EDSP
proposed
statement
of
policy,
was
subsequently
reviewed
by
a
joint
panel
of
the
FIFRA
Scientific
Advisory
Panel
(
SAP)
and
the
EPA
Science
Advisory
Board
(
SAB)
in
May
1999.
The
SAP/
SAB
issued
a
final
report
that
concluded
that
a
tiered
approach
relying
on
a
combination
of
in
vivo
and
in
vitro
screens
for
Tier
I
and
a
set
of
in
vivo
Tier
II
tests
was
scientifically
reasonable.

D.
Implementation
of
EPA's
Endocrine
Disruptor
Screening
Program
EPA's
ongoing
implementation
of
EDSP
is
science­
driven,
and
supported
by
the
recommendations
and
comments
of
EDSTAC,
the
SAP/
SAB
Joint
Panel,
and
the
EDMVS.
The
Agency's
Implementation
is
currently
proceeding
on
three
fronts:
Priority
setting
for
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/
Vol.
68,
No.
104
/
Friday,
May
30,
2003
/
Notices
chemicals
to
be
screened
and
tested:
Prevalidation
and
validation
studies
on
Tier
I
and
Tier
II
assays;
and
developing
policy
and
procedures
to
require
endocrine
disruptor
testing.
1.
Priority
setting.
Priority
setting
is
a
separate
activity
from
the
EDMVS.
For
the
latest
information
on
priority
setting
of
chemicals
for
testing
see
Federal
Register
of
December
30,
2002,
(
67
FR
79611)
(
FRL
 
7286
 
6)
and
docket
ID
number
OPPT
 
2002
 
0066.
2.
Validation
process.
As
a
charter
member
of
the
Interagency
Coordinating
Committee
on
the
Validation
of
Alternative
Methods
(
ICCVAM),
EPA
is
following
the
interagency
validation
framework
outlined
in
the
ICCVAM
report
``
Validation
and
Regulatory
Acceptance
of
Toxicological
Test
Methods''
for
validating
the
EDSP
screening
and
testing
methods.
The
National
Institute
of
Environmental
Health
Sciences
(
NIEHS)
established
ICCVAM
as
a
standing
committee
of
Federal
agencies
to
coordinate
and
facilitate
interagency
validation,
acceptance,
and
harmonization
of
toxicological
test
methods
with
an
emphasis
on
reducing
animal
use,
refining
procedures
involving
animals
to
make
them
less
stressful
and
replacing
animals
where
scientifically
appropriate.
The
ICCVAM
validation
process
was
designed
as
a
flexible,
adaptable
framework
applicable
to
conventional
and
alternative
methods,
and
to
meet
the
needs
of
diverse
test
sponsors,
Federal
agencies
and
regulatory
processes.
EPA's
EDSP
is
managing
the
validation
process
with
substantial
involvement
of
ICCVAM
personnel.
Although
there
is
widespread
interest
in
EPA's
EDSP,
the
screening
and
testing
methods
are
being
developed
and
validated
with
the
specific
goal
of
developing
test
guidelines
for
EPA
regulatory
use.
The
test
guidelines
will
ultimately
be
used
by
chemical
manufacturers,
pesticide
registrants,
and
other
entities
to
develop
data
for
submission
to
EPA
in
support
of
the
Agency's
statutorily
mandated
chemical
risk
management
programs.
In
addition
to
EPA's
domestic
EDSP
validation
program,
certain
screening
assays
and
tests
for
international
use
are
also
being
developed
by
the
Organization
for
Economic
Cooperation
and
Development
(
OECD)
Test
Guidelines
Program.
EPA
is
an
active
member
of
the
OECD
Test
Guidelines
Program
activities,
as
well
as
the
latter's
Endocrine
Disruptor
Testing
and
Assessment
Workgroup.
EPA
will
rely
upon
the
OECD
mechanism
for
validating
those
EDSP
screens
and
tests
of
international
interest.
The
OECD,
EPA,
and
ICCVAM
have
also
mutually
agreed
to
this
administrative
arrangement
to
ensure
that
all
appropriate
validation
and
peer
review
steps
are
achieved
in
both
domestic
and
international
efforts.
3.
Status
of
validation
of
the
assays.
The
table
below
shows
the
validation
process
steps
that
have
been
initiated
on
each
of
the
assays.

Screens/
Assays
Literature
Review
Initial
Protocol
Demonstration
Prevalidation
Studies
Validation
Studies
Amphibian
metamorphosis
X
X
X
AR
binding
X
X
X
Aromatase
X
X
X
ER
binding
X
X
X
X
Fish
reproductive
X
X
X
Hershberger
X
X
X
Pubertal
female
X
X
X
Pubertal
male
X
X
X
Steroidogenesis
X
X
X
Uterotrophic
(
Tier
?)
X
X
X
X
Amphibian
2
 
generation
development
and
reproduction
test
X
X
Avian
2
 
generation
test
X
X
X
Fish
life­
cycle
test
X
Mammalian
2
 
generation
test
X
X
Mysid
life­
cycle
test
X
X
X
4.
Policy
and
procedures
workgroup.
The
Agency
has
established
a
workgroup
composed
of
scientists,
economists,
lawyers,
and
policy
specialists
from
different
EPA
offices
that
is
in
the
process
of
developing
policy
and
procedures
related
to
requiring
endocrine
disruptor
testing.
List
of
Subjects
Environmental
protection,
Endocrine
disruption,
Endocrine
disruptor
screening
program.
Dated:
May
21,
2003.

Stephen
Johnson,

Assistant
Administrator,
Office
of
Prevention,
Pesticides
and
Toxic
Substances.
[
FR
Doc.
03
 
13432
Filed
5
 
29
 
03;
8:
45
am]

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