Document ID: EPA-HQ-OPP-2003-0132-0135
Agency: epa
Document Type: Proposed Rule
Title: Human Testing; Advance Notice of Proposed Rulemaking; Reopening of a Comment Period
Posted Date: 2003-08-06T04:00Z

46535
Federal
Register
/
Vol.
68,
No.
151
/
Wednesday,
August
6,
2003
/
Proposed
Rules
beneficiary)
does
not
have
the
option
of
waiving
the
full
use
of
public
facilities
which
are
determined
by
the
Director,
TRICARE
Management
Activity
or
designee
to
be
available
and
adequate
to
meet
a
disability
related
need
for
which
an
ECHO
benefit
was
requested.
Benefits
eligible
for
payment
under
a
state
plan
for
medical
assistance
under
Title
XIX
of
the
Social
Security
Act
(
Medicaid)
are
never
considered
to
be
available
in
the
adjudication
of
ECHO
benefits.
*
*
*
*
*

Dated:
July
29,
2003.
L.
M.
Bynum,
Alternate
OSD
Federal
Register
Liaison
Officer,
Department
of
Defense.
[
FR
Doc.
03
 
19822
Filed
8
 
5
 
03;
8:
45
am]

BILLING
CODE
5001
 
08
 
M
ENVIRONMENTAL
PROTECTION
AGENCY
40
CFR
Chapter
I
[
OPP
 
2003
 
0132;
FRL
 
7322
 
3]

RIN:
2070
 
AD57
Human
Testing;
Advance
Notice
of
Proposed
Rulemaking;
Reopening
of
a
Comment
Period
AGENCY:
Environmental
Protection
Agency
(
EPA).
ACTION:
Advance
notice
of
proposed
rulemaking;
reopening
of
comment
period.

SUMMARY:
On
May
7,
2003,
EPA
announced
the
availability
for
comment
of
an
advance
notice
of
proposed
rulemaking
(
ANPR)
discussing
EPA's
plan
to
conduct
rulemaking
about
criteria
and
standards
EPA
would
apply
in
deciding
the
extent
to
which
it
will
consider
or
rely
on
various
types
of
research
with
human
subjects
to
support
its
actions.
The
Agency
received
a
request
to
extend
the
comment
period.
EPA
is
hereby
reopening
the
comment
period,
which
ended
on
August
5,
2003.
The
new
comment
period
will
end
August
20,
2003.
DATES:
Comments,
identified
by
the
docket
ID
number
OPP
 
2003
 
0132,
must
be
received
on
or
before
August
20,
2003.
ADDRESSES:
Comments
may
be
submitted
electronically,
by
mail,
or
through
hand
delivery/
courier.
Follow
the
detailed
instructions
as
provided
in
Unit
I.
C.
of
the
SUPPLEMENTARY
INFORMATION
of
the
May
7,
2003
Federal
Register
document.
FOR
FURTHER
INFORMATION
CONTACT:
William
L.
Jordan,
Mail
code
7501C,
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001;
telephone
number:
(
703)
305
 
1049;
fax
number:
(
703)
308
 
4776;
e­
mail
address:
jordan.
william@
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
particular
interest
to
those
who
conduct
testing
of
substances
regulated
by
EPA.
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
 
0132.
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.
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.
Once
in
the
system,
select
``
search,''
then
key
in
the
appropriate
docket
ID
number.

C.
How
and
to
Whom
Do
I
Submit
Comments?

To
submit
comments,
or
access
the
official
public
docket,
please
follow
the
detailed
instructions
as
provided
in
Unit
I.
C.
of
the
SUPPLEMENTARY
INFORMATION
of
the
May
7,
2003
Federal
Register
document.
If
you
have
questions,
consult
the
person
listed
under
FOR
FURTHER
INFORMATION
CONTACT.

II.
What
Action
is
EPA
taking?

This
document
reopens
the
public
comment
period
established
in
the
Federal
Register
of
May
7,
2003
(
68
FR
24410)
(
FRL
 
7302
 
8).
In
that
document,
EPA
sought
comment
on
its
plan
to
conduct
rulemaking
about
criteria
and
standards
the
Agency
would
apply
in
deciding
the
extent
to
which
it
will
consider
or
rely
on
various
types
of
research
with
human
subjects
to
support
its
actions.
The
Agency
received
a
request
to
extend
the
comment
period.
EPA
is
hereby
reopening
the
comment
period,
which
ended
on
August
5,
2003.
The
new
comment
period
will
end
August
20,
2003.
The
public
is
strongly
encouraged
to
submit
comments
as
early
as
possible
so
that
EPA
may
make
them
available
for
consideration
by
a
committee
of
the
National
Academy
of
Sciences,
which
is
preparing
a
report
for
EPA
on
these
issues.

III.
What
is
the
Agency's
Authority
for
Taking
this
Action?

Section
25(
a)
of
FIFRA
gives
the
Administrator
authority
to
``
prescribe
regulations
to
carry
out
the
purposes
of
[
FIFRA].''
Such
a
rule
would
implement
EPA's
authority
to
require
data
in
support
of
registration
of
pesticides
(
see,
for
example,
FIFRA
sections
3(
c)(
1)(
F)
and
3(
c)(
2)(
B))
and
to
interpret
the
provision
making
it
unlawful
for
any
person
``
to
use
any
pesticide
in
tests
on
human
beings
unless
such
human
beings
(
i)
are
fully
informed
of
the
nature
and
purposes
of
the
test
and
of
any
physical
and
mental
health
consequences
which
are
reasonably
foreseeable
therefrom,
and
(
ii)
freely
volunteer
to
participate
in
the
test.''
(
FIFRA
section
12(
a)(
2)(
P)).
In
addition,
section
408(
e)(
1)(
C)
of
the
FFDCA
authorizes
the
Administrator
to
issue
a
regulation
establishing
``
general
procedures
and
requirements
to
implement
this
section.''

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46536
Federal
Register
/
Vol.
68,
No.
151
/
Wednesday,
August
6,
2003
/
Proposed
Rules
IV.
Do
Any
Statutory
and
Executive
Order
Reviews
Apply
to
this
Action?

No.
This
action
is
not
a
rulemaking,
it
merely
extends
the
date
by
which
public
comments
must
be
submitted
to
EPA
on
an
ANPR
that
previously
published
in
the
Federal
Register
of
May
7,
2003
(
68
FR
24410).
For
information
about
the
applicability
of
the
regulatory
assessment
requirements
to
the
ANPR,
please
refer
to
the
discussion
in
Unit
III.
A.
of
that
document
(
68
FR
24410).

List
of
Subjects
Environmental
protection,
Human
studies.

Dated:
August
1,
2003.
James
Jones,
Director,
Office
of
Pesticide
Programs.
[
FR
Doc.
03
 
20154
Filed
8
 
5
 
03;
8:
45
am]

BILLING
CODE
6560
 
50
 
S
ENVIRONMENTAL
PROTECTION
AGENCY
40
CFR
Part
51
[
FRL
 
7540
 
3]

RIN
2060
 
AJ99
Draft
Regulatory
Text
for
Proposed
Rule
To
Implement
the
8­
Hour
Ozone
National
Ambient
Air
Quality
Standard
AGENCY:
Environmental
Protection
Agency
(
EPA).
ACTION:
Notice
of
availability.

SUMMARY:
Notice
is
hereby
given
that
the
Environmental
Protection
Agency
(
EPA)
has
developed
draft
regulatory
text
to
accompany
the
proposed
rule
to
implement
the
8­
hour
ozone
national
ambient
air
quality
standard
(
NAAQS)
which
was
published
on
June
2,
2003
(
68
FR
32802).
If,
after
notice
and
comment,
we
adopt
approaches
other
than
those
reflected
by
the
draft
regulatory
text,
the
regulatory
text
we
promulgate
at
the
time
of
our
final
action
will
incorporate
the
approaches
we
adopt.
DATES:
Comments
must
be
received
on
or
before
September
5,
2003.
ADDRESSES:
Comments
on
the
draft
regulatory
text
should
be
submitted
to
Docket
#
OAR
2003
 
0079.
When
mailing
documents,
commnents
or
requests
to
the
EPA
Docket
Center
through
the
U.
S.
Postal
Service,
please
use
the
following
address:
U.
S.
Environmental
Protection
Agency,
EPA
West
(
Air
Docket),
1200
Pennsylvania
Avenue,
NW.,
Room
B108,
Mail
Code
6102T,
Washington,
DC
20460.
The
normal
business
hours
are
8:
30
a.
m.
to
4:
30
p.
m.,
Monday
through
Friday,
excluding
Federal
holidays.
Comments
can
be
submitted
to
the
address
above,
by
fax
(
202)
566
 
1741,
or
by
e­
mail
to
A­
and­
RDocket
epa.
gov.
The
voice
telephone
number
is
(
202)
566
 
1742.
In
addition,
we
have
placed
a
variety
of
materials
regarding
the
8­
hour
ozone
implementation
proposed
rule
on
the
Web
site:
http://
www.
epa.
gov/
ttn/
naaqs/
ozone/
o3imp8hr.
While
the
Web
site
is
not
an
exact
duplicate
of
the
Air
Docket,
we
have
placed
materials
that
we
have
generated
and
materials
that
have
been
submitted
in
electronic
format
on
the
Web
site.
The
draft
regulatory
text
is
available
for
public
inspection
at
EPA's
Web
site
at:
www.
epa.
gov/
ttn/
naaqs/
ozone/
o3imp8hr
and
at
the
Office
of
Air
and
Radiation
(
OAR)
Docket
Center,
Docket
Number
OAR
2003
 
0079,
respectively.
Copies
of
the
draft
regulatory
text
can
also
be
obtained
from
the
Ozone
Policy
and
Strategies
Group,
Office
of
Air
Quality
Planning
and
Standards
(
C539
 
02),
U.
S.
Environmental
Protection
Agency,
Research
Triangle
Park,
NC
27711.

FOR
FURTHER
INFORMATION
CONTACT:
Mr.
John
Silvasi,
Office
of
Air
Quality
Planning
and
Standards,
U.
S.
Environmental
Protection
Agency,
Mail
Code
C539
 
02,
Research
Triangle
Park,
NC
27711,
phone
number
(
919)
54l­
5666
or
by
e­
mail
at:
silvasi.
john@
epa.
gov
or
Ms.
Denise
Gerth,
Office
of
Air
Quality
Planning
and
Standards,
U.
S.
Environmental
Protection
Agency,
Mail
Code
C539
 
02,
Research
Triangle
Park,
NC
27711,
phone
number
(
919)
54l­
5550
or
by
e­
mail
at:
gerth.
denise@
epa.
gov.
SUPPLEMENTARY
INFORMATION:
The
draft
regulatory
text
for
the
8­
hour
ozone
implementation
proposed
rule
is
intended
to
accompany
the
June
2,
2003,
proposed
rule
to
implement
the
8­
hour
ozone
NAAQS.
The
draft
regulatory
text
contains
most
of
the
major
elements
of
the
implementation
approach,
e.
g.,
the
transition
from
the
1­
hour
to
the
8­
hour
ozone
NAAQS
and
how
to
implement
the
Clean
Air
Act's
provisions
related
to
anti­
backsliding.
In
the
draft
regulatory
text,
we
are
not
yet
addressing
the
options
concerning
new
source
review,
i.
e.,
the
transitional
program
and
the
Clean
Air
Development
Communities
program.
The
June
2,
2003
proposed
rule
contains
the
background
discussion
for
the
draft
regulatory
text.
The
June
2,
2003
proposal
sets
forth
for
comment
several
options
for
certain
features
or
plan
elements;
the
draft
regulatory
text
provides
the
regulatory
text
for
only
one
of
the
options
being
proposed
for
each
feature
or
element
to
demonstrate
how
the
regulatory
text
would
appear
for
that
set
of
options.
Selection
of
a
particular
option
was
generally
based
on
the
preferences
stated
in
the
June
2,
2003
proposal;
however,
this
selection
should
not
be
interpreted
as
a
decision
by
EPA
to
proceed
with
that
option
in
the
final
rule,
since
comments
are
still
being
received
on
the
June
2,
2003,
proposal.
The
draft
regulatory
text
would
also
amend
40
CFR
part
81
by
adding
and
reserving
a
new
subpart
E,
which
would
be
used
to
identify
the
area
designations
and
classifications
for
the
1­
hour
standard
in
place
at
the
time
the
1­
hour
standard
no
longer
applies
to
each
area;
this
is
being
done
to
implement
the
proposed
rule
on
anti­
backsliding.

A.
How
Can
I
Get
Copies
of
This
Document?

1.
Docket.
The
EPA
has
established
an
official
docket
for
this
action
under
Docket
ID
Number
2003
 
0079.
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
or
other
information
whose
disclosures
is
restricted
by
statute.
The
official
public
docket
is
the
collection
of
materials
that
is
available
for
public
viewing
at
the
OAR
Docket
Center,
(
EPA/
DC)
EPA
West,
Room
B102,
1301
Constitution
Avenue,
NW.,
Washington,
DC.
The
EPA
Docket
Center
Public
Reading
Room
is
open
from
8:
30
a.
m.
to
4:
30
p.
m.,
Monday
through
Friday,
excluding
legal
holidays.
The
telephone
number
for
the
Public
Reading
Room
is
(
202)
566
 
1744,
and
the
telephone
number
for
the
OAR
Docket
is
(
202)
566
 
1742.

List
of
Subjects
in
40
CFR
Part
51
Environmental
protection,
Air
pollution
control,
Intergovernmental
relations,
Ozone,
Particulate
matter,
Transportation,
Volatile
organic
compounds.

Authority:
42
U.
S.
C.
7408,
42
U.
S.
C.
7410,
42
U.
S.
C.
7501
 
7511f;
42
U.
S.
C.
7601(
a)(
1).

Dated:
July
28,
2003.

Tom
Curran,

Acting
Director,
Office
of
Air
Quality
Planning
and
Standards.
[
FR
Doc.
03
 
20030
Filed
8
 
5
 
03;
8:
45
am]

BILLING
CODE
6560
 
50
 
P
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