Document ID: EPA-HQ-OPP-2003-0132-0003
Agency: epa
Document Type: Proposed Rule
Title: Human Testing; Advance Notice of Proposed Rulemaking
Posted Date: 2003-05-07T04:00Z

24410
Federal
Register
/
Vol.
68,
No.
88
/
Wednesday,
May
7,
2003
/
Proposed
Rules
Unfunded
Mandates
Reform
Act
The
Unfunded
Mandates
Reform
Act
of
1995
(
2
U.
S.
C.
1531
 
1538)
requires
Federal
agencies
to
assess
the
effects
of
their
discretionary
regulatory
actions.
In
particular,
the
Act
addresses
actions
that
may
result
in
the
expenditure
by
a
State,
local,
or
tribal
government,
in
the
aggregate,
or
by
the
private
sector
of
$
100,000,000
or
more
in
any
one
year.
Though
this
proposed
rule
would
not
result
in
such
expenditure,
we
do
discuss
the
effects
of
this
rule
elsewhere
in
this
preamble.

Taking
of
Private
Property
This
proposed
rule
would
not
effect
a
taking
of
private
property
or
otherwise
have
taking
implications
under
Executive
Order
12630,
Governmental
Actions
and
Interference
with
Constitutionally
Protected
Property
Rights.

Civil
Justice
Reform
This
proposed
rule
meets
applicable
standards
in
sections
3(
a)
and
3(
b)(
2)
of
Executive
Order
12988,
Civil
Justice
Reform,
to
minimize
litigation,
eliminate
ambiguity,
and
reduce
burden.

Protection
of
Children
We
have
analyzed
this
proposed
rule
under
Executive
Order
13045,
Protection
of
Children
from
Environmental
Health
Risks
and
Safety
Risks.
This
rule
is
not
an
economically
significant
rule
and
would
not
create
an
environmental
risk
to
health
or
risk
to
safety
that
might
disproportionately
affect
children.

Indian
Tribal
Governments
This
proposed
rule
does
not
have
tribal
implications
under
Executive
Order
13175,
Consultation
and
Coordination
with
Indian
Tribal
Governments,
because
it
would
not
have
a
substantial
direct
effect
on
one
or
more
Indian
tribes,
on
the
relationship
between
the
Federal
Government
and
Indian
tribes,
or
on
the
distribution
of
power
and
responsibilities
between
the
Federal
Government
and
Indian
tribes.
We
invite
your
comments
on
how
this
proposed
rule
might
impact
tribal
governments,
even
if
that
impact
may
not
constitute
a
``
tribal
implication''
under
the
order.

Energy
Effects
We
have
analyzed
this
proposed
rule
under
Executive
Order
13211,
Actions
Concerning
Regulations
That
Significantly
Affect
Energy
Supply,
Distribution,
or
Use.
We
have
determined
that
it
is
not
a
``
significant
energy
action''
under
that
order
because
it
is
not
a
``
significant
regulatory
action''
under
Executive
Order
12866
and
is
not
likely
to
have
a
significant
adverse
effect
on
the
supply,
distribution,
or
use
of
energy.
It
has
not
been
designated
by
the
Administrator
of
the
Office
of
Information
and
Regulatory
Affairs
as
a
significant
energy
action.
Therefore,
it
does
not
require
a
Statement
of
Energy
Effects
under
Executive
Order
13211.

Environment
We
have
considered
the
environmental
impact
of
this
rule
and
concluded
that
under
figure
2
 
1,
paragraph
(
34)(
g),
of
Commandant
Instruction
M16475.
lD,
this
rule
is
categorically
excluded
from
further
environmental
documentation
because
we
are
establishing
a
security
zone.
A
``
Categorical
Exclusion
Determination''
and
checklist
are
available
in
the
docket
for
inspection
or
copying
where
indicated
under
ADDRESSES.
Comments
on
this
section
will
be
considered
before
we
make
the
final
decision
on
whether
the
rule
should
be
categorically
excluded
from
further
environmental
review.

List
of
Subjects
in
33
CFR
Part
165
Harbors,
Marine
safety,
Navigation
(
water),
Reporting
and
record­
keeping
requirements,
Security
measures,
Waterways.
For
the
reasons
discussed
in
the
preamble,
the
Coast
Guard
proposes
to
amend
33
CFR
part
165
as
follows:

PART
165
 
REGULATED
NAVIGATION
AREAS
AND
LIMITED
ACCESS
AREAS
1.
The
authority
citation
for
Part
165
continues
to
read
as
follows:

Authority:
33
U.
S.
C.
1231;
50
U.
S.
C.
191,
33
CFR
1.05
 
1(
g),
6.04
 
1,
6.04
 
6,
and
160.5;
Department
of
Homeland
Security
Delegation
No.
0170.

2.
Add
§
165.1109
to
read
as
follows:

§
165.1109
Security
Zone;
National
City
Marine
Terminal,
San
Diego,
CA.

(
a)
Location.
The
security
zone
consists
of
the
navigable
waters
surrounding
the
National
City
Marine
Terminal
and
encompassing
Sweetwater
Channel.
The
limits
of
this
security
zone
are
more
specifically
defined
as
the
area
enclosed
by
the
following
points:
starting
on
shore
at
32
°
39 
25 
N
117
°
07 
15 
W,
then
extending
northerly
to
32
°
39 
32 
N
117
°
07 
16 
W,
then
extending
westerly
to
32
°
39 
29 
N
117
°
07 
36 
W,
then
southerly
to
32
°
39 
05 
N
117
°
07 
34 
W,
and
then
easterly
to
shore
at
32
°
39 
06 
N
117
°
07 
14.5 
W.
All
coordinates
are
North
American
Datum
1983.
(
b)
Regulations.
(
1)
In
accordance
with
the
general
regulations
in
§
165.33
of
this
part,
entry
into,
transit
through,
or
anchoring
within
the
security
zone
by
all
vessels
is
prohibited
during
military
outloads,
unless
authorized
by
the
Captain
of
the
Port,
or
his
designated
representative.
All
other
general
regulations
of
§
165.33
of
this
part
apply
in
the
security
zone
established
by
this
section.
(
2)
Persons
desiring
to
transit
the
area
of
the
security
zone
may
contact
the
Captain
of
the
Port
on
VHF
channel
16
or
VHF
channel
21A
to
seek
permission
to
transit
the
area.
Additionally,
the
COTP
representative
may
be
reached
at
(
619)
683
 
6470
ext
2.
If
permission
is
granted,
all
persons
and
vessels
must
comply
with
the
instructions
of
the
Captain
of
the
Port
or
his
or
her
designated
representatives.
(
c)
Enforcement.
The
U.
S.
Coast
Guard
may
be
assisted
in
the
patrol
and
enforcement
of
this
security
zone
by
the
San
Diego
Harbor
Police.
(
d)
Notice.
Enforcement
of
the
security
zone
will
be
announced
via
broadcast
notice
to
mariners,
local
notice
to
mariners,
or
by
any
other
means
that
is
deemed
appropriate.
(
e)
Authority.
In
addition
to
33
U.
S.
C.
1231,
the
authority
for
this
section
includes
33
U.
S.
C.
1226.

Dated:
April
17,
2003.
Stephen
P.
Metruck,
Commander,
U.
S.
Coast
Guard,
Captain
of
the
Port,
San
Diego,
California.
[
FR
Doc.
03
 
11296
Filed
5
 
6
 
03;
8:
45
am]

BILLING
CODE
4910
 
15
 
P
ENVIRONMENTAL
PROTECTION
AGENCY
40
CFR
Chapter
I
[
OPP
 
2003
 
0132;
FRL
 
7302
 
8]

RIN:
2070
 
AD57
Human
Testing;
Advance
Notice
of
Proposed
Rulemaking
AGENCY:
Environmental
Protection
Agency
(
EPA).
ACTION:
Advance
notice
of
proposed
rulemaking.

SUMMARY:
This
advance
notice
of
proposed
rulemaking
announces
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.
This
notice
also
initiates
the
rulemaking
process
by
requesting
public
comments
and
suggestions
on
a
broad
range
of
issues
relating
to
this
subject.

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Federal
Register
/
Vol.
68,
No.
88
/
Wednesday,
May
7,
2003
/
Proposed
Rules
DATES:
Comments
must
be
received
on
or
before
August
5,
2003.

ADDRESSES:
Submit
your
comments,
identified
by
docket
ID
number
OPP
 
2003
 
0132,
online
at
http://
www.
epa.
gov/
edocket
(
EPA's
preferred
method)
or
mailed
to
the
Public
Information
and
Records
Integrity
Branch
(
PIRIB),
(
7502C),
Office
of
Pesticide
Programs
(
OPP),
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001.
For
additional
submission
methods
and
detailed
instructions,
go
to
Unit
I.
C.
of
the
SUPPLEMENTARY
INFORMATION.

FOR
FURTHER
INFORMATION
CONTACT:
William
L.
Jordan,
Mail
code
7501C,
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460;
telephone
number:
(
703)
305
 
1049,
fax
number:
(
703)
308
 
4776;
e­
mail
address:
jordan.
william@
epa.
gov.

SUPPLEMENTARY
INFORMATION:
This
Advance
Notice
of
Proposed
Rulemaking
(
ANPR)
is
organized
into
four
Units.
Unit
I.
contains
``
General
Information''
about
the
applicability
of
this
ANPR,
how
to
obtain
additional
information,
how
to
submit
comments
in
response
to
the
request
for
comments,
and
certain
other
related
matters.
Unit
II.
provides
background
and
historic
information
pertaining
to
human
subject
research.
Unit
III.
describes
the
rulemaking
process,
identifies
relevant
statutory
provisions,
and
requests
public
comments
and
suggestions
on
a
broad
range
of
issues
related
to
the
Agency's
consideration
of
or
reliance
on
research
with
human
subjects.
Unit
IV.
describes
procedures
followed
in
the
development
of
this
ANPR
and
certain
statutes
and
Executive
Orders
that
the
public
may
wish
to
consider
in
preparing
comments.

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.
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
on
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
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Federal
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/
Vol.
68,
No.
88
/
Wednesday,
May
7,
2003
/
Proposed
Rules
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
 
0132.
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
 
0132.
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
 
2003
 
0132.
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
 
0132.
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.
Make
sure
to
submit
your
comments
by
the
deadline
in
this
ANPR.
7.
To
ensure
proper
receipt
by
EPA,
be
sure
to
identify
the
docket
control
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.
Introduction
A.
Background
on
Federal
Standards
for
Conducting
Human
Research
Over
the
years,
scientific
research
with
human
subjects
has
provided
much
valuable
information
to
help
characterize
and
control
risks
to
public
health,
but
its
use
has
also
raised
particular
ethical
concerns
for
the
welfare
of
the
human
participants
in
such
research
as
well
as
scientific
issues
related
to
the
role
of
such
research
in
assessing
risks.
Society
has
responded
to
these
concerns
by
defining
general
standards
for
conducting
human
research.
In
the
United
States,
the
National
Commission
for
the
Protection
of
Human
Subjects
of
Biomedical
and
Behavioral
Research
issued
in
1979
``
The
Belmont
Report:
Ethical
Principles
and
Guidelines
for
the
Protection
of
Human
Subjects
of
Research.''
This
document
can
be
found
on
the
web
at
http://
ohrp.
osophs.
dhhs.
gov/
humansubjects/
guidance/
belmont.
htm.
For
most
federal
agencies
in
the
United
States,
the
principles
of
the
Belmont
Report
are
implemented
through
the
Common
Rule,
which
was
developed
cooperatively
by
some
17
departments
and
agencies,
including
EPA,
and
which
guides
all
research
with
human
subjects
conducted
or
supported
by
these
departments
and
agencies
of
the
federal
government.
The
Common
Rule
as
promulgated
by
EPA
(
40
CFR
part
26)
has
guided
human
research
conducted
or
supported
by
EPA
since
it
was
put
in
place
in
1991.
More
broadly,
the
international
medical
research
community
has
developed
and
maintains
ethical
standards
documented
in
the
Declaration
of
Helsinki,
first
issued
by
the
World
Medical
Association
in
1964
and
revised
several
times
since
then.
These
standards
apply
to
research
on
matters
relating
to
the
diagnosis
and
treatment
of
human
disease,
and
to
research
that
adds
to
understanding
of
the
causes
of
disease
and
the
biological
mechanisms
that
explain
the
relationships
between
human
exposures
to
environmental
agents
and
disease.
In
addition,
many
public
and
private
research
and
academic
institutions
and
private
companies,
both
in
the
United
States
and
in
other
countries,
including
non­
federal
U.
S.
and
non­
U.
S.
governmental
organizations,
have
their
own
specific
policies
related
to
the
protection
of
human
participants
in
research.
Much
of
the
scientific
research
supporting
EPA's
actions,
including
a
significant
portion
of
the
research
with
human
subjects
submitted
to
the
Agency
or
retrieved
by
the
Agency
from
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Rules
published
sources,
is
conducted
by
this
broader
research
community,
without
direct
participation
or
support
by
the
U.
S.
government.
Such
research,
referred
to
here
as
``
third
party''
research,
while
it
may
be
governed
by
specific
institutional
policies
intended
to
protect
research
participants
or
may
fall
within
the
scope
of
the
Declaration
of
Helsinki,
is
not
subject
to
the
Common
Rule.
In
general,
EPA
cannot
readily
determine
whether
such
policies
are
consistent
with
or
as
protective
of
human
subjects
as
the
Common
Rule,
nor
the
extent
to
which
such
policies
or
standards
have
been
followed
in
the
conduct
of
any
particular
study.
Thus,
even
well­
conducted
third­
party
human
studies
may
raise
difficult
questions
for
the
Agency
when
it
seeks
to
determine
their
acceptability
for
consideration.

B.
Human
Research
Issues
in
EPA's
Pesticide
Program
Questions
about
the
Agency's
consideration
of
and
reliance
on
thirdparty
human
research
studies
have
arisen
most
notably,
but
not
exclusively,
in
EPA's
pesticides
program.
Under
the
Federal
Insecticide,
Fungicide,
and
Rodenticide
Act
(
FIFRA),
EPA
may
require
pesticide
companies
to
conduct
studies
with
human
subjects,
for
example,
to
measure
potential
exposure
to
pesticide
users
or
to
workers
and
others
who
re­
enter
areas
treated
with
pesticides,
and
to
evaluate
the
effectiveness
of
pesticide
products
intended
to
repel
insects
and
other
pests
from
human
skin.
In
addition,
EPA
sometimes
encourages
other
research
with
human
subjects,
including
tests
of
the
potential
for
some
pesticides­­
generally
those
designed
for
prolonged
contact
with
human
skin­­
to
irritate
or
sensitize
human
skin,
and
tests
of
the
metabolic
fate
of
pesticides
in
the
human
system.
These
latter
studies
typically
precede
monitoring
studies
of
agricultural
workers
and
others
to
protect
them
from
exposure
to
potentially
dangerous
levels
of
pesticide
residues.
In
addition
to
these
kinds
of
research
which
have
been
required
or
encouraged
by
EPA,
other
kinds
of
studies
involving
human
subjects
intentionally
exposed
to
pesticides
have
occasionally
been
submitted
to
the
agency
voluntarily.
Among
these
voluntarily
submitted
studies
have
been
tests
involving
intentional
dosing
of
human
subjects
to
establish
a
No
Observed
Adverse
Effect
Level
(
NOAEL)
or
No
Observed
Effect
Level
(
NOEL)
for
systemic
toxicity
of
certain
pesticides
to
humans.
Before
passage
of
the
Food
Quality
Protection
Act
(
FQPA)
in
1996,
submission
of
such
studies
was
rare.
EPA
considered
and
relied
on
human
NOAEL/
NOEL
studies
in
a
few
regulatory
decisions
on
pesticides
made
prior
to
1996.
Since
the
passage
of
FQPA,
submission
of
these
types
of
studies
to
the
Office
of
Pesticide
Programs
has
increased;
the
Agency
has
received
some
20
studies
of
this
kind
since
1996.
In
response
to
concerns
about
human
testing
expressed
in
a
report
of
a
nongovernmental
advocacy
organization,
the
Environmental
Working
Group,
in
July
1998,
the
Agency
began
a
systematic
review
of
its
policy
and
practice.
In
a
press
statement
on
July
28,
1998,
EPA
noted
that
it
had
not
relied
on
any
such
studies
in
any
final
decisions
made
under
FQPA;
this
remains
true
today.
In
further
response
to
growing
public
concern
over
pesticide
research
with
human
subjects,
EPA
convened
an
advisory
committee
under
the
joint
auspices
of
the
EPA
Science
Advisory
Board
(
SAB)
and
the
FIFRA
Scientific
Advisory
Panel
(
SAP)
to
address
issues
of
the
scientific
and
ethical
acceptability
of
such
research.
This
advisory
committee,
known
as
the
Data
from
Testing
of
Human
Subjects
Subcommittee
(
DTHSS),
met
in
December
1998
and
November
1999,
and
completed
its
report
in
September
2000.
Their
report
is
available
in
the
Docket
cited
above
in
this
ANPR,
and
on
the
web
at:
http://
www.
epa.
gov/
science1/
pdf/
ec0017.
pdf
The
DTHSS
advisory
committee
heard
many
comments
at
their
two
public
meetings,
and
further
comments
have
been
submitted
in
response
to
their
published
report.
No
clear
consensus
emerged
from
the
advisory
committee
process
on
the
acceptability
of
NOAEL
or
NOEL
studies
of
systemic
toxicity
of
pesticides
to
human
subjects,
and
significant
differences
of
opinion
remain
on
both
their
scientific
merit
and
ethical
acceptability.
A
vigorous
public
debate
continues
about
the
extent
to
which
EPA
should
accept,
consider,
or
rely
on
third­
party
intentional
dosing
human
toxicity
studies
with
pesticides.

C.
EPA's
Current
Agency­
wide
Focus
on
Human
Research
Issues
EPA
is
now
interested
in
addressing
these
issues
more
broadly,
and
in
all
Agency
programs.
In
December
2001,
EPA
asked
the
advice
of
the
National
Academy
of
Sciences
(
NAS)
on
the
many
difficult
scientific
and
ethical
issues
raised
by
this
debate,
and
also
stated
the
Agency's
interim
approach
on
third­
party
intentional
dosing
human
subjects
studies.
The
Agency's
press
release
on
this
subject
is
on
the
web
at
http://
yosemite.
epa.
gov/
opa/
admpress.
nsf/
b1ab9f485b098972
852562e7004dc686/
c232a45f5473
717085256b2200740ad4?
OpenDocument.
At
that
time
the
Agency
committed
that
when
it
receives
the
NAS
report,
``
EPA
will
engage
in
an
open
and
participatory
process
involving
federal
partners,
interested
parties
and
the
public
during
its
policy
development
and/
or
rulemaking
regarding
future
acceptance,
consideration
or
regulatory
reliance
on
such
human
studies.''
Since
making
that
commitment,
EPA
has
decided
to
initiate
a
rulemaking
process
by
issuing
this
ANPR.
In
early
2002,
various
parties
from
the
pesticide
industry
filed
a
petition
with
the
U.
S.
Court
of
Appeals
for
the
District
of
Columbia
for
review
of
EPA's
December
2001
press
release.
These
parties
argued
that
the
Agency's
interim
approach
constituted
a
``
rule''
promulgated
in
violation
of
the
procedural
requirements
of
the
Administrative
Procedure
Act
and
the
Federal
Food,
Drug,
and
Cosmetic
Act.
The
court
has
denied
motions
concerning
emergency
relief
and
other
matters,
briefs
have
been
filed,
and
oral
argument
of
the
merits
of
the
case
occurred
on
March
17,
2003.
Under
a
contract
with
EPA,
the
NAS
has
convened
a
committee
to
provide
the
requested
advice.
The
committee
met
in
December
2002,
and
again
in
January
and
March
2003.
The
membership,
meeting
schedule,
and
other
information
about
the
work
of
this
committee
can
be
found
on
the
NAS
website
at:
http://
www4.
nas.
edu/
webcr.
nsf/
5c50571a75df494485256a95007
a091e/
9303f725c15902f685256c44005d8931?
OpenDocument&
Highlight=
0,
EPA.
The
committee's
final
report
is
due
in
December
2003.
Notwithstanding
these
many
recent
developments
concerning
human
studies,
some
things
have
not
changed.
EPA
remains
committed
to
full
compliance
with
the
Common
Rule
for
all
research
with
human
subjects
conducted
or
supported
by
the
Agency.
This
body
of
research
has
provided
many
important
insights
and
has
contributed
significantly
to
the
protection
of
human
health.
The
Agency
will
continue
to
conduct
and
support
such
research,
and
to
consider
and
rely
on
its
results
in
Agency
actions.
EPA
also
remains
committed
to
scientifically
sound
assessments
of
the
hazards
of
environmental
agents,
taking
into
consideration
available,
relevant,
and
appropriate
scientific
research.

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III.
EPA's
Rulemaking
Process
and
Request
for
Public
Comment
EPA
intends
to
undertake
notice­
andcomment
rulemaking
on
the
subject
of
its
consideration
of
or
reliance
on
research
involving
human
subjects.
The
Agency
will
particularly
focus
on
thirdparty
intentional
dosing
human
studies,
but
recognizes
that
the
principles
applicable
to
third­
party
studies
may
also
be
relevant
to
studies
conducted
or
supported
by
the
federal
government.
The
first
step
in
this
process
is
this
ANPR
which
calls
for
comments
and
suggestions
from
all
interested
parties.
The
next
step
the
Agency
would
expect
to
undertake
would
be
to
issue
a
proposed
rule
for
public
comment.
In
developing
any
proposed
rule,
EPA
will
consider
the
advice
in
the
National
Academy
of
Sciences
committee
report,
along
with
comments
received
in
response
to
this
ANPR.
Comments
received
on
any
proposed
rule
would
then
be
taken
into
consideration
in
developing
a
final
rule
or
policy.
In
general,
the
Agency
expects
that
any
rule
or
policy
coming
out
of
this
process
may
do
one
or
more
of
the
following:
 
Specify,
if
and
to
the
extent
determined
by
EPA
to
be
appropriate,
whether
EPA
would
accept,
consider,
or
rely
on
results
from
particular
types
of
studies
involving
intentional
dosing
of
human
subjects
or
from
human
studies
with
particular
characteristics.
 
Establish
minimum
standards
relating
to
the
protection
of
human
subjects
which
would
be
required
to
be
met
in
the
design
and
conduct
of
a
study
with
human
subjects,
in
order
for
EPA
to
accept,
consider,
or
rely
on
the
results
of
the
study.
 
Establish
procedures
for
ensuring
that
any
minimum
standards
for
the
conduct
of
third­
party
research
with
human
subjects
had
been
adhered
to
in
the
conduct
of
any
such
study
that
EPA
intended
to
accept,
consider,
or
rely
on.

A.
Legal
Authority
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.''
The
Clean
Air
Act
gives
EPA
general
rulemaking
authority
in
42
U.
S.
C.
7601(
a).
The
Clean
Water
Act,
33
U.
S.
C.
1361,
authorizes
the
Administrator
to
promulgate
regulations
necessary
to
carry
out
the
Agency's
functions
under
that
Act.
Section
42
U.
S.
C.
9615
in
the
Comprehensive
Environmental
Response,
Compensation,
and
Liability
Act
authorizes
the
President
to
establish
regulations
to
implement
the
statute;
this
authority
has
been
delegated
to
EPA
by
Executive
Order
12580.
The
Emergency
Planning
and
Community
Right­
to­
Know
Act
also
contains
a
general
rulemaking
provision,
42
U.
S.
C.
11048,
authorizing
the
Administrator
to
promulgate
rules
necessary
to
carry
out
the
Act.
The
Resource
Conservation
and
Recovery
Act
specifically
authorizes
the
Administrator
to
prescribe
regulations
necessary
to
carry
out
EPA's
functions
under
the
Act,
42
U.
S.
C.
6912.
The
Safe
Drinking
Water
Act
contains
similar
language,
authorizing
the
Administrator
to
prescribe
such
regulations
``
as
are
necessary
and
appropriate''
to
carry
out
EPA's
functions
under
the
Act,
42
U.
S.
C.
300j­
9.
In
addition,
EPA
has
authority
under
5
U.
S.
C.
301
and
42
U.
S.
C.
300v­
1(
b).

B.
Request
for
Comments
Neither
this
ANPR
nor
the
specific
questions
presented
below
for
public
comment
are
intended
to
indicate
that
EPA
now
favors
any
particular
policy
approaches
regarding
the
Agency's
consideration
of
or
reliance
on
thirdparty
intentional
dosing
human
studies.
Similarly,
neither
this
ANPR
nor
the
specific
questions
presented
below
for
public
comment
are
intended
to
indicate
that
EPA
has
decided
on
a
particular
scope
for
any
potential
future
rulemaking.
Nor
is
this
ANPR
intended
to
impede
or
otherwise
delay
any
Agency
assessments
or
actions.
Rather,
this
ANPR
is
designed
to
encourage
public
input
from
all
interested
parties
on
a
broad
range
of
issues
that
could
help
inform
any
rule
or
policy
that
EPA
eventually
promulgates
or
issues,
respectively.
The
Agency
fully
appreciates
the
number,
the
range,
and
the
interconnectedness
of
the
scientific
and
ethical
concerns
raised
especially
by
intentional
dosing
human
studies
of
the
wide
range
of
environmental
agents
addressed
by
EPA's
programs.
Reflecting
the
breadth
of
issues
that
have
been
raised,
the
Agency
has
identified
specific
questions
on
which
it
particularly
invites
comment.
These
questions
are
intended
to
help
organize
and
focus
the
discussion,
but
not
to
constrain
it.
Commenters
should
feel
free
to
address
any
other
relevant
topics
as
well.
1.
Applicability
of
existing
standards
 
a.
Is
it
appropriate
to
use
a
standard
intended
to
guide
the
conduct
of
research
(
e.
g.,
the
Common
Rule,
Declaration
of
Helsinki,
or
the
Nuremberg
Code)
to
assess
the
acceptability
for
review
of
completed
research?
b.
Is
it
appropriate
to
use
a
standard
intended
to
guide
the
conduct
of
therapeutic
or
diagnostic
medical
research
or
to
clarify
causes
of
disease,
such
as
the
Declaration
of
Helsinki,
to
assess
the
acceptability
for
review
of
other
kinds
of
research
without
diagnostic
or
therapeutic
intent,
conducted
with
healthy
subjects?
c.
Should
the
Agency
apply
the
same
standard
of
acceptability
independent
of
the
type
of
substance
tested
(
e.
g.,
pharmaceutical,
pesticide,
pathogen,
or
environmental
contaminant)?
If
not,
how
might
differing
standards
be
applied
when
a
single
substance
has
multiple
uses,
e.
g.,
as
both
a
pesticide
and
a
drug?
d.
Does
it
matter
who
maintains
a
standard,
or
by
what
process
it
is
maintained?
For
example,
would
it
be
appropriate
for
EPA
to
accept
and
apply
a
standard
maintained
by
a
private,
nongovernmental
organization,
as
is
the
Declaration
of
Helsinki?
e.
Should
the
Agency
extend
the
requirements
of
the
Common
Rule
to
the
conduct
of
third­
party
research
with
human
subjects
intended
for
submission
to
EPA?
What
are
the
advantages
and
disadvantages
of
conducting
a
rulemaking
or
undertaking
other
Agency
action
for
this
purpose
alone?
2.
Should
the
standard
of
acceptability
vary
depending
on
the
research
design?
 
a.
Should
the
Agency
apply
the
same
standard
of
acceptability
independent
of
whether
the
research
design
involves
intentional
exposure?
For
example,
should
the
same
standard
apply
to
research
involving
intentional
exposures
to
human
subjects,
to
research
designed
to
follow­
up
accidental
exposure,
and
to
studies
of
individuals
occupationally
or
incidentally
exposed?
b.
Should
the
Agency
apply
the
same
standard
of
acceptability
independent
of
the
level
of
exposure
of
the
human
subjects?
For
example,
does
it
matter
if
the
level
of
exposure
to
a
chemical
is
below
the
Reference
Dose
or
other
established
health
standard
designed
to
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Proposed
Rules
protect
the
general
public?
Should
the
same
standard
apply
if
intentional
exposure
to
an
environmental
pollutant
occurs
at
ambient
levels,
or
at
elevated
levels?
If
research
involves
intentional
exposure
to
a
pesticide,
does
it
matter
if
exposure
results
from
use
of
the
pesticide
in
conformity
with
approved
label
directions?
c.
Should
the
Agency
apply
the
same
standard
of
acceptability
independent
of
the
pathway
of
exposure?
For
example,
should
the
same
standard
apply
when
exposure
is
oral,
or
dermal,
or
by
inhalation?
d.
Should
the
Agency
apply
the
same
standard
of
acceptability
independent
of
the
effects
being
evaluated?
For
example,
should
the
same
standard
apply
to
a
study
measuring
transitory
changes
in
blood
chemistry
or
levels
of
a
substance
in
urine
that
applies
to
studies
measuring
longer­
lasting
changes?
Should
the
same
standard
apply
to
a
study
of
localized
skin
irritation
that
applies
to
a
study
of
systemic
dermal
toxicity?
Should
the
same
standard
apply
to
studies
measuring
organoleptic
effects,
such
as
taste
or
smell,
that
applies
to
studies
of
toxic
effects?
Should
the
same
standard
apply
to
measurements
of
toxic
effects
and
to
measurements
through
genomic
or
proteomic
assessments?
e.
Should
conduct
of
research
in
compliance
with
the
provisions
of
the
Common
Rule
or
another
standard
for
the
protection
of
human
subjects
be
accepted
as
evidence
of
its
ethical
acceptability?
f.
Should
the
Agency
consider
whether
research
has
been
performed
consistent
with
an
EPA
guideline
for
data
development
in
determining
its
acceptability?
For
example,
EPA
has
published
guidelines
for
certain
kinds
of
human
studies
required
for
pesticide
registration;
should
conduct
of
a
required
study
in
compliance
with
an
EPA
guideline
be
accepted
as
evidence
of
its
acceptability?
g.
Should
the
Agency
apply
the
same
standard
of
acceptability
independent
of
a
study's
statistical
power?
h.
Should
the
Agency
apply
the
same
standard
of
acceptability
whether
or
not
a
human
study
design
is
able
to
measure
the
same
endpoints
in
humans
that
have
been
observed
in
animal
testing
of
the
same
substance?
For
example,
if
the
most
sensitive
adverse
effects
shown
in
animal
studies
have
been
detected
through
histopathological
evaluation
of
brain
tissue,
is
subsequent
research
involving
intentional
exposure
of
human
subjects
acceptable?
i.
Should
the
Agency
apply
the
same
standard
of
acceptability
to
intentional
dosing
studies
independent
of
whether
there
are
alternative
methods
of
obtaining
data
of
comparable
scientific
merit
that
would
not
require
deliberate
exposure
of
humans?
If
not,
to
what
extent,
if
any,
should
the
cost
of
the
alternate
method
be
a
factor?
j.
What
special
considerations,
if
any,
should
the
Agency
apply
in
judging
the
acceptability
of
studies
when
some
or
all
of
the
subjects
are
from
populations
likely
to
be
vulnerable
to
coercion
or
undue
influence,
such
as
children,
prisoners,
pregnant
women,
mentally
disabled
persons,
or
economically
or
educationally
disadvantaged
persons?
3.
Should
the
standard
of
acceptability
vary
depending
on
the
provenance
of
the
research?
 
a.
Should
the
Agency
apply
the
same
standard
of
acceptability
without
regard
to
who
or
what
organization
sponsors
or
supports
the
research?
Since
1991,
human
research
conducted
or
supported
by
the
U.
S.
government
has
been
subject
to
the
Common
Rule.
Should
the
same
standard
apply
to
research
conducted
or
supported
by
others?
Should
a
single
standard
apply
independent
of
whether
the
sponsor
is
a
commercial
enterprise,
a
non­
profit
organization,
another
government
in
the
United
States
(
such
as
state,
tribal,
or
local),
or
the
government
in
another
country?
Should
the
same
standard
apply
without
regard
to
the
test
sponsor's
interest
in
a
regulatory
matter
that
could
be
affected
by
EPA's
consideration
of
the
data?
b.
Should
the
Agency
apply
the
same
standard
of
acceptability
independent
of
who
or
what
organization
conducts
the
research?
For
example,
a
research
organization­­
public
or
private­­
holding
a
``
Federal­
Wide
Assurance''
from
the
Department
of
Health
and
Human
Services's
Office
of
Human
Research
Protections
usually
promises
to
comply
with
the
Common
Rule
in
all
its
human
research.
Should
third­
party
work
conducted
by
a
research
organization
holding
a
Federal­
Wide
Assurance
be
assessed
by
the
same
standard
that
applies
to
other
third­
party
human
research?
c.
Should
the
Agency
apply
the
same
standard
of
acceptability
without
regard
to
where
the
research
was
conducted?
For
example,
does
it
matter
whether
research
is
conducted
entirely
in
the
United
States
or
partially
in
the
United
States?
If
it
is
conducted
outside
the
United
States,
does
it
matter
in
what
country
it
is
conducted?
What
are
the
advantages
and
disadvantages
of
judging
the
acceptability
of
human
studies
based
on
a
single
uniform
standard
versus
prevailing
local
standards
(
e.
g.,
in
different
countries)?
d.
Should
the
Agency
apply
the
same
standard
of
acceptability
without
regard
to
the
reasons
the
research
was
conducted?
If
not,
how
might
the
Agency
determine
intent?
e.
Should
the
Agency
apply
the
same
standard
of
acceptability
to
submitted
research
without
regard
to
who
submitted
it?
For
example,
should
the
same
standard
apply
to
submissions
from
regulated
industry,
from
public
interest
groups,
from
the
public,
or
from
other
governments?
Should
the
Agency
apply
the
same
standard
of
acceptability
independent
of
whether
the
study
was
submitted
voluntarily,
or
in
response
to
a
particular
regulatory
requirement
of
EPA?
f.
Should
the
Agency
apply
the
same
standard
of
acceptability
to
human
research
which
is
not
submitted,
but
which
the
Agency
obtains
at
its
own
initiative
from
the
scientific
literature
or
other
sources,
independent
of
how
or
where
EPA
obtains
it?
4.
Should
the
standard
of
acceptability
vary
depending
on
EPA's
potential
use
of
the
data?
 
a.
Should
the
Agency
apply
the
same
standard
of
acceptability
independent
of
whether
the
results
of
the
study
would
support
a
more
or
less
stringent
regulatory
position?
For
example,
should
the
same
standard
apply
whether
the
data
indicate
that
the
substance
tested
is
more
risky
or
less
risky
than
is
indicated
by
other
available
data?
b.
Should
the
Agency
apply
the
same
standard
of
acceptability
without
regard
to
how
EPA
intends
to
use
the
results,
e.
g.,
to
reduce
or
remove
the
traditional
tenfold
interspecies
uncertainty
factor,
to
provide
an
endpoint
for
use
in
calculating
a
Reference
Dose
or
Reference
Concentration
for
the
test
substance,
to
provide
a
dose­
response
function
for
use
in
quantitative
risk
assessment,
or
for
some
other
purpose?
5.
Should
the
standard
of
acceptability
vary
depending
on
EPA's
assessment
of
the
risks
and
benefits
of
the
research
to
the
subjects
or
to
society?
 
a.
Should
the
Agency
apply
a
standard
of
acceptability
based
on
a
comparison
of
the
anticipated
benefits
of
the
research
in
relation
to
the
risks
to
human
subjects,
provided
the
risks
are
minimized
and
informed
consent
is
obtained?
b.
Should
the
Agency
independently
assess
the
risks
of
the
research
to
the
subjects
and
the
benefits
of
the
research
to
the
research
subjects
or
to
society,
or
should
it
defer
to
the
judgment
of
Institutional
Review
Boards
or
similar
oversight
panels?
c.
If
EPA
were
to
assess
independently
the
risks
and
benefits
of
human
research,
on
what
range
of
information
should
it
base
its
assessment?
How
might
EPA
obtain
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information
relevant
to
such
an
assessment?
6.
How
should
the
Agency
implement
standards
of
acceptability?
 
a.
To
what
extent
and
how
should
the
submitter
of
research
with
human
subjects
to
EPA
be
required
to
document
or
otherwise
demonstrate
compliance
with
appropriate
standards
for
the
protection
of
human
research
subjects,
e.
g.,
fully
informed
and
fully
voluntary
participation,
and
independent
oversight
of
research
design
and
conduct
by
an
Institutional
Review
Board
or
comparable
entity?
b.
How
should
the
Agency
determine
compliance
with
an
appropriate
standard
for
human
research
data
which
is
not
submitted,
but
which
it
obtains
from
the
scientific
literature
or
other
sources?
c.
To
what
extent
should
new
standards
be
applied
to
research
which
has
already
been
conducted,
or
is
underway?
Should
a
different
standard
be
applied
to
such
research?
Does
fairness
require
a
period
of
transition
to
any
new
rule
or
standards
of
acceptability,
or
do
other
considerations
override
that
factor?
d.
Should
the
Agency
apply
the
same
standard
of
acceptability
to
research
already
submitted
to
or
obtained
by
EPA
and
to
research
newly
submitted
to
or
obtained
by
EPA?
Does
it
matter
if
the
submitted
research
was
conducted
for
the
specific
regulatory
purpose
at
hand
or
for
other
purposes
(
even
though
the
study
was
conducted
after
EPA
issued
a
policy
on
human
testing)?
Does
fairness
require
a
period
of
transition
to
any
new
rule
or
standards
of
acceptability,
or
do
other
considerations
override
that
factor?
e.
Is
rulemaking
needed
at
all?
Would
it
be
better
to
address
the
issues
surrounding
acceptance
of
human
research,
or
some
of
them,
by
other
means,
such
as
policy
statements
or
internal
guidelines?

IV.
Statutory
and
Executive
Order
Reviews
Under
Executive
Order
12866,
entitled
Regulatory
Planning
and
Review
(
58
FR
51735,
October
4,
1993),
it
has
been
determined
that
this
ANPR
is
a
``
significant
regulatory
action''
under
section
3(
f)
of
the
Executive
Order.
The
Agency
therefore
submitted
this
document
to
OMB
for
the
10
 
day
review
period
afforded
under
this
Executive
Order.
Any
changes
made
in
response
to
OMB
comments
during
that
review
have
been
documented
in
the
public
docket
as
required
by
the
Executive
Order.
Since
this
ANPR
does
not
impose
any
requirements,
and
instead
seeks
comments
and
suggestions
for
the
Agency
to
consider
in
developing
a
subsequent
notice
of
proposed
rulemaking,
the
various
other
review
requirements
that
apply
when
an
agency
imposes
requirements
do
not
apply
to
this
action.
As
part
of
your
comments
on
this
ANPR
you
may
include
any
comments
or
information
that
you
have
regarding
these
requirements.
In
particular,
any
comments
or
information
that
would
help
the
Agency
to
assess
the
potential
impact
of
a
rule
on
small
entities
pursuant
to
the
Regulatory
Flexibility
Act
(
RFA)
(
5
U.
S.
C.
601
et
seq.);
to
consider
voluntary
consensus
standards
pursuant
to
section
12(
d)
of
the
National
Technology
Transfer
and
Advancement
Act
of
1995
(
NTTAA),
Public
Law
104
 
113,
section
12(
d)
(
15
U.
S.
C.
272
note);
or
to
consider
environmental
health
or
safety
effects
on
children
pursuant
to
Executive
Order
13045,
entitled
Protection
of
Children
from
Environmental
Health
Risks
and
Safety
Risks
(
62
FR
19885,
April
23,
1997).
The
Agency
will
consider
such
comments
during
the
development
of
any
subsequent
notice
of
proposed
rulemaking
as
it
takes
appropriate
steps
to
address
any
applicable
requirements.

List
of
Subjects
Environmental
protection,
Protection
of
human
research
subjects.

Dated:
April
29,
2003.
Christine
T.
Whitman,
Administrator.

[
FR
Doc.
03
 
11002
Filed
5
 
6
 
03;
8:
45
am]

BILLING
CODE
6560
 
50
 
S
ENVIRONMENTAL
PROTECTION
AGENCY
40
CFR
Part
52
[
MD136
 
3091b;
FRL
 
7484
 
1]

Approval
and
Promulgation
of
Air
Quality
Implementation
Plans;
Maryland;
Amendments
to
State
II
Vapor
Recovery
at
Gasoline
Dispensing
Facilities
AGENCY:
Environmental
Protection
Agency
(
EPA).
ACTION:
Proposed
rule.

SUMMARY:
EPA
proposes
to
approve
the
State
Implementation
Plan
(
SIP)
revision
submitted
by
the
State
of
Maryland
for
the
purpose
of
amending
the
regulations
pertaining
to
Stage
II
Vapor
Recovery
at
Gasoline
Dispensing
Stations.
In
the
Final
Rules
section
of
this
Federal
Register,
EPA
is
approving
the
State's
SIP
submittal
as
a
direct
final
rule
without
prior
proposal
because
the
Agency
views
this
as
a
noncontroversial
submittal
and
anticipates
no
adverse
comments.
A
detailed
rationale
for
the
approval
is
set
forth
in
the
direct
final
rule.
If
no
adverse
comments
are
received
in
response
to
this
action,
no
further
activity
is
contemplated.
If
EPA
receives
adverse
comments,
the
direct
final
rule
will
be
withdrawn
and
all
public
comments
received
will
be
addressed
in
a
subsequent
final
rule
based
on
this
proposed
rule.
EPA
will
not
institute
a
second
comment
period.
Any
parties
interested
in
commenting
on
this
action
should
do
so
at
this
time.

DATES:
Comments
must
be
received
in
writing
by
June
6,
2003.

ADDRESSES:
Written
comments
should
be
addressed
to
Makeba
Morris,
Acting
Chief,
Air
Quality
Planning
and
Information
Services
Branch,
Mailcode
3AP21,
U.
S.
Environmental
Protection
Agency,
Region
III,
1650
Arch
Street,
Philadelphia,
Pennsylvania
19103.
Copies
of
the
documents
relevant
to
this
action
are
available
for
public
inspection
during
normal
business
hours
at
the
Air
Protection
Division,
U.
S.
Environmental
Protection
Agency,
Region
III,
1650
Arch
Street,
Philadelphia,
Pennsylvania
19103;
and
the
Maryland
Department
of
the
Environment,
1800
Washington
Boulevard,
Suite
705,
Baltimore,
Maryland
21230.

FOR
FURTHER
INFORMATION
CONTACT:
Kathleen
Anderson,
(
215)
814
 
2173,
or
by
e­
mail
at
anderson.
kathleen@
epa.
gov.

SUPPLEMENTARY
INFORMATION:
For
further
information,
please
see
the
information
provided
in
the
direct
final
action,
with
the
same
title,
that
is
located
in
the
``
Rules
and
Regulations''
section
of
this
Federal
Register
publication.
Please
note
that
if
EPA
receives
adverse
comment
on
an
amendment,
paragraph,
or
section
of
this
rule
and
if
that
provision
may
be
severed
from
the
remainder
of
the
rule,
EPA
may
adopt
as
final
those
provisions
of
the
rule
that
are
not
the
subject
of
an
adverse
comment.

Dated:
April
9,
2003.

James
W.
Newsom,

Regional
Administrator,
Region
III.
[
FR
Doc.
03
 
11184
Filed
5
 
6
 
03;
8:
45
am]

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CODE
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50
 
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