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/
Vol.
68,
No.
16
/
Friday,
January
24,
2003
/
Rules
and
Regulations
country,''
as
defined
in
18
U.
S.
C.
1151.
Indian
country
includes:
1.
All
lands
within
the
exterior
boundaries
of
Indian
reservations
within
or
abutting
the
State
of
Ohio;
2.
Any
land
held
in
trust
by
the
U.
S.
for
an
Indian
tribe;
and
3.
Any
other
land,
whether
on
or
off
an
Indian
reservation
that
qualifies
as
Indian
country.
Therefore,
this
action
has
no
effect
on
Indian
country.
EPA
retains
the
authority
to
implement
and
administer
the
RCRA
program
in
Indian
country.
However,
at
this
time,
there
is
no
Indian
country
within
the
State
of
Ohio.

I.
What
Is
Codification
and
Is
EPA
Codifying
Ohio's
Hazardous
Waste
Program
as
Authorized
in
This
Rule?
Codification
is
the
process
of
placing
a
state's
statutes
and
regulations
that
comprise
the
state's
authorized
hazardous
waste
program
into
the
Code
of
Federal
Regulations.
We
do
this
by
referencing
the
authorized
state
rules
in
40
CFR
part
272.
We
reserve
the
amendment
of
40
CFR
part
272,
subpart
P,
for
authorization
of
Ohio's
program
revisions
until
a
later
date.

J.
Administrative
Requirements
The
Office
of
Management
and
Budget
has
exempted
RCRA
authorization
from
the
requirements
of
Executive
Order
12866
(
58
FR
51735,
October
4,
1993),
and
therefore
this
action
is
not
subject
to
review
by
OMB.
Furthermore,
this
action
is
not
subject
to
Executive
Order
13211,
``
Actions
Concerning
Regulations
That
Significantly
Affect
Energy
Supply,
Distribution,
or
Use''
(
66
FR
28355,
May
22,
2001)
because
it
is
not
a
significant
regulatory
action
under
Executive
Order
12866.
This
action
authorizes
State
requirements
for
the
purpose
of
RCRA
3006
and
imposes
no
additional
requirements
beyond
those
imposed
by
state
law.
This
authorization
will
effectively
suspend
the
applicability
of
certain
federal
regulations
in
favor
of
Ohio's
program,
thereby
eliminating
duplicate
requirements
in
the
state.
Authorization
will
not
impose
any
new
burdens
on
small
entities.
Accordingly,
I
certify
that
this
action
will
not
have
a
significant
economic
impact
on
a
substantial
number
of
small
entities
under
the
Regulatory
Flexibility
Act
(
5
U.
S.
C.
601
et
seq.).
Because
this
action
authorizes
pre­
existing
requirements
under
state
law
and
does
not
impose
any
additional
enforceable
duty
beyond
that
required
by
state
law,
it
does
not
contain
any
unfunded
mandate
or
significantly
or
uniquely
affect
small
governments,
as
described
in
the
Unfunded
Mandates
Reform
Act
of
1995
(
Pub.
L.
104
 
4).
This
action
does
not
have
tribal
implications
within
the
meaning
of
Executive
Order
13175
(
65
FR
67249,
November
9,
2000).
This
action
will
not
have
substantial
direct
effects
on
the
states,
on
the
relationship
between
the
national
government
and
the
states,
or
on
the
distribution
of
power
and
responsibilities
among
the
various
levels
of
government,
as
specified
in
Executive
Order
13132
(
64
FR
43255,
August
10,
1999),
because
it
merely
authorizes
state
requirements
as
part
of
the
state
RCRA
hazardous
waste
program
without
altering
the
relationship
or
the
distribution
of
power
and
responsibilities
established
by
RCRA.
This
action
also
is
not
subject
to
Executive
Order
13045
(
62
FR
19885,
April
23,
1997),
because
it
is
not
economically
significant
and
it
does
not
make
decisions
based
on
environmental
health
or
safety
risks.
This
action
does
not
include
environmental
justicerelated
issues
that
require
consideration
under
Executive
Order
12898
(
59
FR
7929,
February
16,
1994).
Under
RCRA
section
3006(
b),
EPA
grants
a
state's
application
for
authorization
as
long
as
the
state
meets
the
criteria
required
by
RCRA.
It
would
thus
be
inconsistent
with
applicable
law
for
EPA,
when
it
reviews
a
state
authorization
application,
to
require
the
use
of
any
particular
voluntary
consensus
standard
in
place
of
another
standard
that
otherwise
satisfies
the
requirements
of
RCRA.
Thus,
the
requirements
of
section
12(
d)
of
the
National
Technology
Transfer
and
Advancement
Act
of
1995
(
15
U.
S.
C.
272)
do
not
apply.
As
required
by
section
3
of
Executive
Order
12988
(
61
FR
4729,
February
7,
1996),
in
issuing
this
rule,
EPA
has
taken
the
necessary
steps
to
eliminate
drafting
errors
and
ambiguity,
minimize
potential
litigation,
and
provide
a
clear
legal
standard
for
affected
conduct.
EPA
has
complied
with
Executive
Order
12630
(
53
FR
8859,
March
15,
1988)
by
examining
the
takings
implications
of
the
rule
in
accordance
with
the
``
Attorney
General's
Supplemental
Guidelines
for
the
Evaluation
of
Risk
and
Avoidance
of
Unanticipated
Takings'
issued
under
the
executive
order.
This
action
does
not
impose
an
information
collection
burden
under
the
provisions
of
the
Paperwork
Reduction
Act
of
1995
(
44
U.
S.
C.
3501
et
seq.).
The
Congressional
Review
Act,
5
U.
S.
C.
801
et
seq.,
as
added
by
the
Small
Business
Regulatory
Enforcement
Fairness
Act
of
1996,
generally
provides
that
before
a
rule
may
take
effect,
the
agency
promulgating
the
rule
must
submit
a
rule
report,
which
includes
a
copy
of
the
rule,
to
each
House
of
the
Congress
and
to
the
Comptroller
General
of
the
United
States.
EPA
will
submit
a
report
containing
this
document
and
other
required
information
to
the
U.
S.
Senate,
the
U.
S.
House
of
Representatives,
and
the
Comptroller
General
of
the
United
States
prior
to
publication
in
the
Federal
Register.
A
major
rule
cannot
take
effect
until
60
days
after
it
is
published
in
the
Federal
Register.
This
action
is
not
a
``
major
rule''
as
defined
by
5
U.
S.
C.
804(
2).

List
of
Subjects
in
40
CFR
Part
271
Environmental
protection,
Administrative
practice
and
procedure,
Confidential
business
information,
Hazardous
materials
transportation,
Hazardous
waste,
Indians­
lands,
Intergovernmental
relations,
Penalties,
Reporting
and
recordkeeping
requirements.

Authority:
This
action
is
issued
under
the
authority
of
sections
2002(
a),
3006
and
7004(
b)
of
the
Solid
Waste
Disposal
Act,
as
amended,
42
U.
S.
C.
6912(
a),
6926,
6974(
b).

Dated:
January
9,
2003.
Bharat
Mathur,
Deputy
Regional
Administrator,
Region
5.
[
FR
Doc.
03
 
1626
Filed
1
 
23
 
03;
8:
45
am]

BILLING
CODE
6560
 
50
 
P
ENVIRONMENTAL
PROTECTION
AGENCY
40
CFR
Part
312
[
FRL
 
7442
 
4]

RIN
2050
 
AF05
Clarification
to
Interim
Standards
and
Practices
for
All
Appropriate
Inquiry
Under
CERCLA
and
Notice
of
Future
Rulemaking
Action
AGENCY:
Environmental
Protection
Agency
(
EPA).
ACTION:
Direct
final
rule.

SUMMARY:
EPA
is
taking
direct
final
action
to
clarify
a
provision
included
in
recent
amendments
to
the
Comprehensive
Environmental
Response,
Compensation,
and
Liability
Act
(
CERCLA).
Specifically,
today's
direct
final
rule
addresses
the
interim
standard
set
by
Congress
in
the
Small
Business
Liability
Relief
and
Brownfields
Revitalization
Act
(``
the
Brownfields
Law'')
for
conducting
``
all
appropriate
inquiry''
to
establish
that
a
landowner
had
no
reason
to
know
of
contamination
at
a
property
under
CERCLA
liability
provisions
prior
to
purchasing
the
property.
Today's
action
clarifies
that,
in
the
case
of
property
purchased
on
or
after
May
31,
1997,
the
requirements
for
conducting
``
all
appropriate
inquiry,''
including
the
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Regulations
conduct
of
such
activities
to
establish
an
innocent
landowner
defense
under
CERCLA,
also
will
be
satisfied
through
the
use
of
ASTM
Standard
E1527
 
2000,
entitled
``
Standard
Practice
for
Environmental
Site
Assessment:
Phase
1
Environmental
Site
Assessment
Process.''
In
addition,
recipients
of
brownfields
site
assessment
grants
will
be
in
compliance
with
the
all
appropriate
inquiry
requirements
if
they
comply
with
the
ASTM
Standard
E1527
 
2000.
DATES:
This
rule
is
effective
on
March
25,
2003,
without
further
notice,
unless
EPA
receives
adverse
comment
by
February
24,
2003.
If
we
receive
such
comment,
we
will
publish
a
timely
withdrawal
in
the
Federal
Register
informing
the
public
that
this
rule
will
not
take
effect.
ADDRESSES:
Comments
on
today's
direct
final
rule
may
be
submitted
electronically,
by
mail,
or
through
hand
delivery/
courier.
Follow
the
detailed
instructions
provided
in
paragraph
B
of
the
SUPPLEMENTARY
INFORMATION
section
below.
Please
reference
Docket
number
SFUND
 
2002
 
0007
when
submitting
your
comments.

FOR
FURTHER
INFORMATION
CONTACT:
For
general
information,
contact
the
RCRA/
CERCLA
Call
Center
at
800
 
424
 
9346
or
TDD
800
 
553
 
7672
(
hearing
impaired).
In
the
Washington,
DC
metropolitan
area,
call
703
 
412
 
9810
or
TDD
703
 
412
 
3323.
For
more
detailed
information
on
specific
aspects
of
this
rule,
contact
Patricia
Overmeyer,
Office
of
Brownfields
Clean
up
and
Redevelopment
(
5105T),
U.
S.
Environmental
Protection
Agency,
1200
Pennsylvania
Avenue,
NW.,
Washington,
DC
20460
 
0002,
202
 
566
 
2774.
overmeyer.
patricia@
epa.
gov.

SUPPLEMENTARY
INFORMATION:

General
Information
A.
How
Can
I
Get
Copies
of
the
Background
Materials
Supporting
Today's
Direct
Final
Rule
or
Other
Related
Information?

1.
EPA
has
established
an
official
public
docket
for
this
direct
final
rule
under
Docket
ID
No.
SFUND
 
2002
 
0007.
The
official
public
docket
consists
of
the
documents
specifically
referenced
in
this
rule
and
other
information
related
to
this
direct
final
rule.
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
EPA
Docket
Center
located
at
1301
Constitution
Ave.
NW,
Washington,
DC
20004.
This
Docket
Facility
is
open
from
8:
30
a.
m.
to
4:
30
p.
m.,
Monday
through
Friday,
excluding
federal
holidays.
To
review
docket
materials,
it
is
recommended
that
the
public
make
an
appointment
by
calling
(
202)
566
 
0276.
The
public
may
copy
a
maximum
of
100
pages
from
any
regulatory
docket
at
no
charge.
Additional
copies
cost
$
0.15/
page.
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/.
You
may
use
EPA
Dockets
at
http://
www.
epa.
gov/
edocket/
to
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
docket
identification
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
above.
For
public
commenters,
it
is
important
to
note
that
EPA's
policy
is
that
public
comments,
whether
submitted
electronically
or
in
paper,
will
be
made
available
for
public
viewing
in
EPA's
electronic
public
docket
as
EPA
receives
them
and
without
change,
unless
the
comment
contains
copyrighted
material,
CBI,
or
other
information
whose
disclosure
is
restricted
by
statute.
When
EPA
identifies
a
comment
containing
copyrighted
material,
EPA
will
provide
a
reference
to
that
material
in
the
version
of
the
comment
that
is
placed
in
EPA's
electronic
public
docket.
The
entire
printed
comment,
including
the
copyrighted
material,
will
be
available
in
the
public
docket.
Public
comments
submitted
on
computer
disks
that
are
mailed
or
delivered
to
the
docket
will
be
transferred
to
EPA's
electronic
public
docket.
Public
comments
that
are
mailed
or
delivered
to
the
Docket
will
be
scanned
and
placed
in
EPA's
electronic
public
docket.
Where
practical,
physical
objects
will
be
photographed,
and
the
photograph
will
be
placed
in
EPA's
electronic
public
docket
along
with
a
brief
description
written
by
the
docket
staff.
For
additional
information
about
EPA's
electronic
public
docket
visit
EPA
Dockets
online
or
see
67
FR
38102,
May
31,
2002.

B.
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
identification
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
will
not
consider
late
comments
in
formulating
a
final
decision.
1.
Electronically.
If
you
submit
an
electronic
comment
as
prescribed
below,
EPA
recommends
that
you
include
your
name,
mailing
address,
and
an
e­
mail
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
party
submitting
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.
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.
To
access
EPA's
electronic
public
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/
Vol.
68,
No.
16
/
Friday,
January
24,
2003
/
Rules
and
Regulations
docket
from
the
EPA
Internet
Home
Page,
select
``
Information
Sources,''
``
Dockets,''
and
``
EPA
Dockets.''
Once
in
the
system,
select
``
search,''
and
then
key
in
Docket
ID
No.
SFUND
 
2002
 
0007.
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.
2.
E­
mail.
Comments
may
be
sent
by
electronic
mail
(
e­
mail)
to
Superfund.
Docket@
epamail.
epa.
gov.
Make
sure
this
electronic
copy
is
in
an
ASCII
format
that
does
not
use
special
characters
or
encryption.
Cite
the
docket
Number
SFUND
 
2002
 
0007
in
your
electronic
file.
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.
3.
Disk
or
CD
ROM.
You
may
submit
comments
on
a
disk
or
CD
ROM
that
you
mail
to
the
mailing
address
identified
above.
These
electronic
submissions
will
be
accepted
in
WordPerfect
or
ASCII
file
format.
Avoid
the
use
of
special
characters
and
any
form
of
encryption.
4.
By
Mail.
Send
two
(
2)
copies
of
your
comments
to:
EPA
Docket
Center,
U.
S.
Environmental
Protection
Agency
Headquarters,
Mail
Code
5305T,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC,
20460,
Attention
Docket
ID
No.
SFUND
 
2002
 
0007.
5.
By
Hand
Delivery
or
Courier.
Deliver
your
comments
to:
EPA
Docket
Center,
EPA
West
Building,
Room
B
 
102,
1301
Constitution
Ave.,
NW.,
Washington,
DC,
20007.
Attention
Docket
ID
No.
SFUND
 
2002
 
0007.
Such
deliveries
are
only
accepted
during
the
Docket's
normal
hours
of
operation
as
identified
above.

Regulated
Entities
Entities
potentially
regulated
by
this
action
include
public
and
private
parties
who,
as
bona
fide
prospective
purchasers,
contiguous
property
owners,
or
innocent
landowners,
purchase
property
and
intend
to
claim
a
limitation
on
CERCLA
liability
in
conjunction
with
the
property
purchase.
In
addition,
any
entity
conducting
a
site
characterization
or
assessment
with
a
brownfields
grant
awarded
under
CERCLA
section104(
k)(
2)(
B)(
ii)
will
be
affected
by
today's
action.
This
includes
state,
local
and
Tribal
governments
that
receive
brownfields
site
assessment
grants.
A
summary
of
the
potentially
affected
industry
sectors
(
by
NAICS
codes)
is
displayed
in
the
table
below.

Industry
category
NAICS
code
Real
Estate
...............................
531
Insurance
..................................
52412
Banking/
Real
Estate
Credit
......
52292
Environmental
Consulting
Services
........................................
54162
State,
Local
and
Tribal
Government
......................................
N/
A
The
list
of
potentially
affected
entities
in
the
above
table
may
not
be
exhaustive.
Our
aim
is
to
provide
a
guide
for
readers
regarding
those
entities
that
EPA
is
aware
potentially
could
be
affected
by
this
action.
However,
this
action
may
affect
other
entities
not
listed
in
the
table.
If
you
have
questions
regarding
the
applicability
of
this
action
to
a
particular
entity,
consult
the
person
listed
in
the
preceding
section
entitled
FOR
FURTHER
INFORMATION
CONTACT.

Preamble
I.
Statutory
Authority
II.
Background
III.
Today's
Action
IV.
Future
Rulemaking
Setting
Standards
for
``
All
Appropriate
Inquiry'
V.
Statutory
and
Executive
Order
Reviews
I.
Statutory
Authority
This
direct
final
rule
clarifies
provisions
included
in
section
223
of
the
Small
Business
Liability
Relief
and
Brownfields
Revitalization
Act
which
amends
section
101(
35)(
B)
of
CERCLA
(
42
U.
S.
C.
9601(
35))
and
clarifies
interim
standards
for
the
conduct
of
``
all
appropriate
inquiry''
for
obtaining
CERCLA
liability
relief
and
for
conducting
site
characterizations
and
assessments
with
the
use
of
brownfields
grant
monies.

II.
Background
On
January
11,
2002,
President
Bush
signed
the
Small
Business
Liability
Relief
and
Brownfields
Revitalization
Act
(``
the
Brownfields
Law'').
In
general,
the
Act
amends
CERCLA
and
provides
funds
to
assess
and
clean
up
brownfields
sites;
clarifies
CERCLA
liability
provisions
related
to
innocent
purchasers
of
contaminated
properties;
and
provides
funding
to
enhance
State
and
Tribal
clean
up
programs.
In
part,
subtitle
B
of
Title
II
of
the
Act
revises
some
of
the
provisions
of
CERCLA
section
101(
35)
and
provides
some
Superfund
liability
limitations
for
bona
fide
prospective
purchasers
and
contiguous
property
owners,
in
addition
to
clarifying
the
requirements
necessary
to
establish
the
innocent
landowner
defense
under
CERCLA.
Among
the
requirements
added
to
CERCLA
is
the
requirement
that
such
parties
undertake
``
all
appropriate
inquiry''
into
prior
ownership
and
use
of
certain
property.
The
Act
requires
EPA
to
develop
regulations
within
two
years
which
will
establish
standards
and
practices
for
how
to
conduct
all
appropriate
inquiry.
In
addition,
in
the
Brownfields
Law,
Congress
established,
as
the
Federal
interim
standard
for
conducting
all
appropriate
inquiry,
the
procedures
of
the
American
Society
for
Testing
and
Materials
(
ASTM)
including
Standard
E1527
 
97
(
entitled
``
Standard
Practice
for
Environmental
Site
Assessment:
Phase
1
Environmental
Site
Assessment
Process'').
This
interim
standard
applies
to
properties
purchased
on
or
after
May
31,
1997
until
EPA
promulgates
Federal
regulations
establishing
standards
and
practices
for
conducting
all
appropriate
inquiry.
Today's
direct
final
rule
clarifies
that
persons
may
use
the
current
ASTM
standard,
E1527
 
2000
for
conducting
all
appropriate
inquiry
and
establishing
the
innocent
landowner
defense
under
CERCLA
section
101(
35)(
B)
for
properties
purchased
on
or
after
May
31,
1997,
while
continuing
also
to
recognize
use
of
ASTM's
previous
standard,
E1527
 
97.
Following
enactment
of
the
Brownfields
Law,
EPA
received
inquiries
from
interested
parties
expressing
concerns
that
the
ASTM
standard
for
all
appropriate
inquiry
that
was
cited
in
the
Act
(
i.
e.,
ASTM's
1997
standard)
has
been
updated
and
consequently
is
no
longer
available
from
ASTM.
The
ASTM
standard
cited
in
the
Brownfields
Law
has
been
updated
and
replaced
with
ASTM's
revised
standard,
``
Standard
E1527
 
2000.''
The
revised
standard
has
the
same
name
as
the
previous
standard.
The
revised
standard
is
not
significantly
different
from
the
previous
standard.
Revisions
to
the
1997
standard
that
are
incorporated
into
the
E1527
 
2000
updated
standard
include
provisions
for
potential
expansion
of
an
assessment,
guidance
for
better
identification
of
the
purpose
of
the
assessment,
a
provision
for
inquiring
about
historical
remediation,
a
provision
for
facilitating
reconstruction
of
the
assessment
by
a
different
assessor,
and
amended
guidance
for
selecting
an
environmental
professional.
A
summary
of
the
revisions
made
to
the
1997
ASTM
standard
and
included
in
the
1527
 
2000
standard
is
provided
in
the
document
``
Overview
of
Additions
and
Modifications
to
ASTM
1527
 
2000
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/
Vol.
68,
No.
16
/
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January
24,
2003
/
Rules
and
Regulations
Standard
from
the
1997
ASTM
Standard.''
A
copy
of
this
document,
as
well
as
an
annotated
copy
of
the
1997
ASTM
standard
identifying
the
specific
modifications
incorporated
into
the
ASTM
2000
standard,
is
included
in
the
regulatory
docket
for
today's
rule.
EPA
believes
that
it
is
consistent
with
Congressional
intent
to
require
the
use
of
the
most
current
standards
available
until
EPA
has
promulgated
its
standard
and
not
to
require
the
use
of
standards
that
have
been
superseded
or
that
generally
are
not
available.
In
addition,
Congress
did
not
intend
to
place
an
undue
burden
on
interested
parties
seeking
to
obtain
and
implement
the
standard.
Given
that
the
version
of
the
ASTM
standard
cited
in
the
Brownfields
Law
is
no
longer
available,
such
an
undue
burden
may
occur,
if
EPA
does
not
undertake
today's
action.
In
particular,
recipients
of
grant
monies
awarded
under
the
new
Brownfields
Law
may
experience
an
undue
burden,
if
required
to
comply
with
the
ASTM
standard
that
no
longer
is
available
or
recognized
as
the
current
industry
standard.
Therefore,
with
today's
action,
EPA
is
clarifying
that
for
the
purposes
of
CERCLA
section
101
(
35)(
B),
until
the
Agency
promulgates
regulations
implementing
standards
for
all
appropriate
inquiry,
parties
may
use
either
the
procedures
provided
in
ASTM
E1527
 
2000,
entitled
``
Standard
Practice
for
Environmental
Site
Assessment:
Phase
I
Environmental
Site
Assessment
Process,''
or
the
standard
ASTM
E1527
 
97.
EPA
has
determined
that
it
is
reasonable
to
promulgate
this
clarification
as
a
direct
final
rule
that
is
effective
immediately,
rather
than
delay
promulgation
of
the
clarification
until
after
receipt
and
consideration
of
public
comments,
to
avoid
any
further
confusion
with
regard
to
the
acceptable
standard
for
conducting
all
appropriate
inquiry
and
to
ensure
that
new
grant
recipients
are
not
placed
under
any
undue
burden.

III.
Today's
Action
EPA
is
publishing
this
direct
final
rule
because
the
Agency
wants
to
reduce
any
undue
burden
placed
upon
grant
recipients.
In
addition,
the
Agency
views
this
as
a
noncontroversial
action
and
anticipates
no
adverse
comment.
We
believe
that
today's
action
is
reasonable
and
can
be
promulgated
without
consideration
of
public
comment
because
it:
(
1)
Allows
for
the
use
of
the
updated
version
of
the
standard
cited
in
the
Brownfields
Law,
while
also
allowing
the
use
of
the
former
version,
and
the
updated
version
of
the
standard
is
similar
to,
and
not
significantly
different
than,
the
previous
standard;
(
2)
reduces
the
burden
of
obtaining
an
appropriate
standard,
given
that
the
standard
cited
in
the
Brownfields
Law
is
no
longer
available;
and
(
3)
this
action
merely
clarifies
an
interim
standard
that
is
effective
only
until
EPA
promulgates
a
final
rule
replacing
the
interim
standard.
Although
we
view
today's
action
as
noncontroversial,
in
the
``
Proposed
Rules''
section
of
today's
Federal
Register,
we
are
publishing
a
separate
proposed
rule
containing
the
clarification
summarized
above.
That
proposed
rule
will
serve
as
the
proposal
to
be
revised,
if
adverse
comments
are
received.
If
EPA
does
not
receive
adverse
comment
in
response
to
this
rule
prior
to
February
24,
2003,
this
rule
will
become
effective
on
March
25,
2003,
without
further
notice.
If
EPA
receives
adverse
comment,
we
will
publish
a
timely
withdrawal
of
this
rule
in
the
Federal
Register
informing
the
public
that
the
rule
will
not
take
effect.
We
will
address
all
public
comments
in
a
subsequent
final
rule.
We
will
not
institute
a
second
comment
period
on
this
action.
Any
parties
interested
in
commenting
must
do
so
at
this
time
and
before
February
24,
2003.

IV.
Future
Rulemaking
Setting
Standards
for
``
All
Appropriate
Inquiry''
EPA
also
is
announcing
today
its
progress
in
developing
regulatory
standards
for
conducting
``
all
appropriate
inquiry.''
The
Brownfields
Law
requires
that
EPA
promulgate
such
standards
within
two
years
of
enactment
of
the
law,
or
by
January
2004.
Congress
included
in
the
Brownfields
Law
a
list
of
criteria
that
the
Agency
must
address
in
the
regulations
establishing
standards
and
practices
for
conducting
all
appropriate
inquiry
(
section
101(
35)(
2)(
B)(
ii)).
The
Act
also
requires
that
parties
receiving
funding
under
the
Federal
brownfields
program
to
conduct
site
assessments
must
conduct
the
site
assessment
in
accordance
with
the
standards
and
practices
for
all
appropriate
inquiry
established
under
the
same
provision
of
the
Act.
EPA
is
soliciting
the
advice
and
input
of
public
and
private
stakeholder
groups
in
developing
the
regulations
for
conducting
all
appropriate
inquiry
in
accordance
with
the
criteria
set
forth
by
Congress.
We
understand
that
voluntary
standards
developed
by
standards
developing
organizations,
such
as
the
ASTM
1527
 
2000
standard,
are
available
and
are
currently
being
used
to
conduct
all
appropriate
inquiry
in
conjunction
with
private
real
estate
property
transactions.
In
addition,
site
assessment
protocols
have
been
established
under
the
Federal
Superfund
remedial
action
and
RCRA
corrective
action
programs,
as
well
as
within
State
clean
up
programs.
We
intend
to
develop
Federal
regulations
that
build
upon
the
depth
of
experience
accrued
in
both
the
public
and
private
sectors
in
implementing
these
standards
and
programs.
We
believe
that
building
upon
currently
available
private
sector
standards
for
undertaking
all
appropriate
inquiry
as
well
as
building
on
the
experience
of
state
and
Federal
government
site
assessment
programs
is
the
most
efficient
and
economical
way
to
develop
Federal
regulatory
standards
that
will
both
meet
the
criteria
set
in
the
Brownfields
Law
and
ensure
minimal
disruption
to
the
private
market
and
State
and
Federal
site
assessment
programs.
To
ensure
that
we
obtain
a
diverse
array
of
input
from
both
private
sector
stakeholders
and
state
program
officials,
EPA
is
developing
the
federal
regulations
by
soliciting
private
and
public
sector
input
under
the
convening
stage
of
the
negotiated
rulemaking
process,
and
may
supplement
our
information
gathering
through
the
conduct
of
public
meetings.
We
initiated
the
convening
stage
of
a
negotiated
rulemaking
process
to
identify
appropriate
stakeholder
groups
and
solicit
advice
and
input
from
experienced
public
and
private
sector
users
of
similar
standards.
Following
an
evaluation
of
stakeholder
interests
and
input
during
the
convening
process,
we
either
will
announce
our
intent
to
continue
with
a
negotiated
rulemaking
process,
or
announce
our
intent
to
solicit
public
input,
by
way
of
an
additional
notice
or
a
public
meeting,
on
options
for
a
proposed
rulemaking
that
will
set
standards
for
all
appropriate
inquiry.
We
anticipate
announcing
our
intended
approach
for
the
development
of
a
proposed
rulemaking
in
the
Federal
Register
during
the
winter
of
2003.
Any
questions
regarding
our
future
regulatory
effort
should
be
directed
to
the
parties
listed
above
in
the
section
entitled
FOR
FURTHER
INFORMATION
CONTACT.

V.
Statutory
and
Executive
Order
Reviews
a.
Under
Executive
Order
12866
(
58
FR
51735,
October
4,
1993),
this
action
is
not
a
``
significant
regulatory
action''
and
is
therefore
not
subject
to
review
by
the
Office
of
Management
and
Budget.
b.
This
rule
does
not
impose
an
information
collection
burden
under
the
provisions
of
the
Paperwork
Reduction
Act
of
1995
(
44
FR
U.
S.
C.
3501
et
seq.)

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/
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24,
2003
/
Rules
and
Regulations
c.
The
Regulatory
Flexibility
Act
(
RFA)
generally
requires
an
agency
to
prepare
a
regulatory
flexibility
analysis
of
any
rule
subject
to
notice
and
comment
rulemaking
requirements
under
the
APA
or
any
other
statute
unless
the
agency
certifies
that
the
rule
will
not
have
a
significant
economic
impact
on
a
substantial
number
of
small
entities.
This
action
will
not
have
a
significant
impact
on
a
substantial
number
of
small
entities
because
it
does
not
create
any
new
requirements.
d.
Because
the
purpose
of
today's
action
is
to
make
a
clarification
that
does
not
create
any
new
requirements
it
has
no
economic
impact
and
is
not
subject
to
sections
202
and
205
of
the
Unfunded
Mandates
Reform
Act
of
1995
(
UMRA)
(
Pubic
Law
104
 
4).
In
addition,
this
action
does
not
significantly
or
uniquely
affect
small
governments
or
impose
a
significant
intergovernmental
mandate,
as
described
in
sections
203
and
204
of
UMRA.
e.
This
rule
will
not
have
substantial
direct
effects
on
the
States,
on
the
relationship
between
the
national
government
and
the
States,
or
on
the
distribution
of
power
and
responsibilities
among
the
various
levels
of
government,
as
specified
in
Executive
Order
13132
(
64
FR
43255,
August
10,
1999).
f.
This
rule
does
not
have
tribal
implications,
as
specified
by
Executive
Order
13175
(
65
FR
67249,
November
6,
2000).
g.
This
rule
is
not
subject
to
Executive
Order
13045
(
62
FR
1985,
April
23,
1997),
because
it
is
not
economically
significant.
h.
This
rule
is
not
subject
to
Executive
Order
13211,
``
Actions
Concerning
Regulations
that
Significantly
Affect
Energy
Supply,
Distribution,
or
Use''
(
66
FR
28355,
May
22,
2001)
because
it
is
not
a
significant
regulatory
action
under
Executive
Order
12866.
i.
This
action
does
involve
technical
standards;
therefore,
the
requirements
of
section
12(
d)
of
the
National
Technology
Transfer
and
Advancement
Act
of
1995
(
15
U.
S.
C.
272)
apply.
The
NTTAA
was
signed
into
law
on
March
7,
1996
and,
among
other
things,
directs
the
National
Institute
of
Standards
and
Technology
(
NIST)
to
bring
together
federal
agencies
as
well
as
state
and
local
governments
to
achieve
greater
reliance
on
voluntary
standards
and
decreased
dependence
on
in­
house
standards.
It
states
that
use
of
such
standards,
whenever
practicable
and
appropriate,
is
intended
to
achieve
the
following
goals:
(
a)
Eliminate
the
cost
to
the
government
of
developing
its
own
standards
and
decrease
the
cost
of
goods
procured
and
the
burden
of
complying
with
agency
regulation;
(
b)
provide
incentives
and
opportunities
to
establish
standards
that
serve
national
needs;
(
c)
encourage
long­
term
growth
for
U.
S.
enterprises
and
promote
efficiency
and
economic
competition
through
harmonization
of
standards;
and
(
d)
further
the
policy
of
reliance
upon
the
private
sector
to
supply
Government
needs
for
goods
and
services.
The
Act
requires
that
federal
agencies
adopt
private
sector
standards,
particularly
those
developed
by
standards
developing
organizations
(
SDOs),
wherever
possible
in
lieu
of
creating
proprietary,
non­
consensus
standards.
Today's
action
is
compliant
with
the
spirit
and
requirements
of
the
NTTAA,
given
that
the
interim
standard
for
all
appropriate
inquiry
that
is
the
subject
of
today's
action
is
a
private
sector
standard
developed
by
a
standard
developing
organization.
Today's
action
allows
for
the
use
of
the
American
Society
for
Testing
and
Materials
(
ASTM)
standard
known
as
Standard
E1527
 
2000
and
entitled
``
Standard
Practice
for
Environmental
Site
Assessment:
Phase
1
Environmental
Site
Assessment
Process''
as
the
interim
standard
for
conducting
all
appropriate
inquiry
for
properties
purchased
on
or
after
May
31,
1997,
or
in
the
alternative,
the
use
of
Standard
E1527
 
97,
and
entitled
``
Standard
Practice
for
Environmental
Site
Assessment:
Phase
1
Environmental
Site
Assessment
Process.''
j.
Today's
action
does
not
involve
special
consideration
of
environmental
justice
related
issues
as
required
by
Executive
Order
12898
(
59
FR
7629,
February
16,
1994).
k.
The
Congressional
Review
Act
(
5
U.
S.
C.
801
et
seq.),
as
added
by
the
Small
Business
Regulatory
Enforcement
Fairness
Act
of
1996,
generally
provides
that
before
a
rule
may
take
effect,
the
agency
promulgating
the
rule
must
submit
a
rule
report,
which
includes
a
copy
of
the
rule,
to
each
House
of
the
Congress
and
to
the
Comptroller
General
of
the
United
States.
EPA
submitted
a
report
containing
this
rule
and
other
required
information
to
the
U.
S.
Senate,
the
U.
S.
House
of
Representatives,
and
the
Comptroller
General
of
the
United
States
prior
to
publication
of
the
rule
in
the
Federal
Register.
A
Major
rule
cannot
take
effect
until
60
days
after
it
is
published
in
the
Federal
Register.
This
action
is
not
a
``
major
rule''
as
defined
by
5
U.
S.
C.
804(
2).
This
rule
will
be
effective
March
25,
2003
unless
EPA
publishes
a
withdrawal
in
the
Federal
Register.
List
of
Subjects
in
40
CFR
Part
312
Environmental
protection,
Administrative
practice
and
procedure,
Hazardous
substances,
Intergovernmental
relations,
Reporting
and
recordkeeping
requirements.

Dated:
January
17,
2003.
Christine
Todd
Whitman,
Administrator.

For
the
reasons
set
out
in
the
preamble,
title
40
chapter
J
of
the
code
of
Federal
Regulations
is
amended
as
follows:
1.
Title
40
Chapter
J
is
amended
by
adding
new
part
312
to
read
as
follows:

PART
312
 
INNOCENT
LANDOWNERS,
STANDARDS
FOR
CONDUCTING
ALL
APPROPRIATE
INQUIRY
Subpart
A
 
Introduction
Sec.
312.1
Purpose
and
applicability.
312.2
Standards
and
practices
for
all
appropriate
inquiry.

Subpart
B
 
[
Reserved]

Authority:
Section
101(
35)(
B)
of
CERCLA,
as
amended,
42
U.
S.
C.
9601(
3)(
B).

Subpart
A
 
Introduction
§
312.1
Purpose
and
applicability.

(
a)
Purpose.
The
purpose
of
this
section
is
to
provide
standards
and
procedures
for
``
all
appropriate
inquiry''
for
the
purposes
of
CERCLA
section
101(
35)(
B).
(
b)
Applicability.
This
section
is
applicable
to:
potential
innocent
landowners
conducting
all
appropriate
inquiry
under
section
101(
35)(
B)
of
CERCLA;
bona
fide
prospective
purchasers
defined
under
section
101(
40)
of
CERCLA;
contiguous
property
owners
under
section
107(
q)
of
CERCLA;
and
persons
conducting
site
characterization
and
assessments
with
the
use
of
a
grant
awarded
under
CERCLA
section
104(
k)(
2)(
B)(
ii).

§
312.2
Standards
and
practices
for
all
appropriate
inquiry.

(
a)
With
respect
to
property
purchased
on
or
after
May
31,
1997,
the
procedures
of
the
American
Society
for
Testing
and
Materials
(
ASTM)
1527
 
97
and
the
procedures
of
the
American
Society
for
Testing
and
Materials
(
ASTM)
1527
 
2000,
both
entitled
``
Standard
Practice
for
Environmental
Site
Assessment:
Phase
1
Environmental
Site
Assessment
Process,''
shall
satisfy
the
requirements
for
conducting
``
all
appropriate
inquiry''
under
section
101(
35)(
B)(
i)(
I)
of
CERCLA,
as
amended
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Federal
Register
/
Vol.
68,
No.
16
/
Friday,
January
24,
2003
/
Rules
and
Regulations
by
the
Small
Business
Liability
Relief
and
Brownfields
Revitalization
Act.

[
FR
Doc.
03
 
1631
Filed
1
 
23
 
03;
8:
45
am]

BILLING
CODE
6560
 
50
 
P
DEPARTMENT
OF
HEALTH
AND
HUMAN
SERVICES
Centers
for
Medicare
&
Medicaid
Services
42
CFR
Part
482
[
CMS
 
3050
 
F]

RIN
0938
 
AK40
Medicare
and
Medicaid
Programs;
Hospital
Conditions
of
Participation:
Quality
Assessment
and
Performance
Improvement
AGENCY:
Centers
for
Medicare
&
Medicaid
Services
(
CMS),
HHS.
ACTION:
Final
rule.

SUMMARY:
This
final
rule
requires
hospitals
to
develop
and
maintain
a
quality
assessment
and
performance
improvement
(
QAPI)
program.
In
the
December
19,
1997
Federal
Register,
we
published
a
proposed
rule
to
revise
the
hospitals
conditions
of
participation
(
CoPs).
The
QAPI
CoP
was
one
of
the
conditions
included
in
the
proposed
rule.
We
separated
the
QAPI
CoP
from
the
larger
set
of
hospital
CoPs
so
that
it
could
be
published
in
advance
of
the
remaining
CoPs
to
implement
the
Administration's
initiatives
regarding
medical
errors.
QAPI
focuses
provider
efforts
on
the
actual
care
delivered
to
patients,
the
performance
of
the
hospital
as
an
organization,
and
the
impact
of
treatment
furnished
by
the
hospital
on
the
health
status
of
its
patients.
Specifically,
it
is
important
to
note
that
a
QAPI
is
not
designed
to
measure
a
hospital's
quality,
but
rather
a
minimum
requirement
that
the
hospital
systematically
examine
its
quality
and
implement
specific
improvement
projects
on
an
ongoing
basis.
State
agencies
(
SAs)
during
their
surveys,
review
all
aspects
of
a
hospital's
operations
and
this
review
provides
a
framework
in
which
the
SA
can
assess
a
hospital's
QAPI
program.
In
addition,
the
QAPI
entails
all
activities
required
for
measuring
quality
of
care
and
maintaining
it
at
acceptable
levels.
This
typically
includes
 
 
Identifying
and
verifying
qualityrelated
problems
and
their
underlying
cause;
 
Designing
and
implementing
corrective
action
activities
to
address
deficiencies;
and
 
Following
up
to
determine
the
degree
of
success
of
an
intervention
and
to
detect
new
problems
and
opportunities
for
improvement.
Performance
improvement
activities
aim
to
improve
overall
performance
assuming
that
there
is
no
permanent
threshold
for
good
performance.
Under
performance
improvement
framework,
hospitals
will
continuously
study
and
improve
the
processes
of
healthcare
and
delivery
of
service.
EFFECTIVE
DATE:
These
regulations
are
effective
on
March
25,
2003.
FOR
FURTHER
INFORMATION
CONTACT:
Nancy
Archer,
(
410)
786
 
0596;
Mary
Collins,
(
410)
786
 
3189;
Monique
Howard,
(
410)
786
 
3869;
Jeannie
Miller,
(
410)
786
 
3164;
SUPPLEMENTARY
INFORMATION:

I.
Background
A.
General
In
the
December
19,
1997
Federal
Register
(
62
FR
66726),
we
published
a
proposed
rule
entitled
``
Medicare
and
Medicaid
Programs;
Hospital
Conditions
of
Participation;
Provider
Agreements
and
Supplier
Approval''
to
revise
the
entire
set
of
Conditions
of
Participation
(
CoPs)
for
hospitals.
The
CoPs
are
the
requirements
that
hospitals
must
meet
to
participate
in
the
Medicare
and
Medicaid
programs.
The
CoPs
are
intended
to
protect
patient
health
and
safety
and
to
ensure
that
high
quality
care
is
provided
to
all
patients.
The
State
survey
agencies
(
SAs),
in
accordance
with
section
1864
of
the
Social
Security
Act
(
the
Act),
survey
hospitals
to
assess
compliance
with
the
CoPs.
The
SAs
conduct
surveys
using
the
instructions
in
the
State
Operations
Manual
(
SOM),
(
Health
Care
Financing
Administration
(
HCFA)
Publication
No.
7).
The
SOM
contains
the
regulatory
language
of
the
CoPs
as
well
as
interpretive
guidelines
and
survey
procedures
and
probes
that
elaborate
on
regulatory
intent
and
give
guidance
on
how
to
assess
provider
compliance.
Under
§
489.10(
d),
the
SAs
determine
whether
hospitals
have
met
the
CoPs
and
report
their
recommendations
to
us.
Under
the
authority
of
section
1865
of
the
Act
and
the
regulations
at
§
488.5,
hospitals
accredited
by
the
Joint
Commission
on
Accreditation
of
Healthcare
Organizations
(
JCAHO)
or
the
American
Osteopathic
Association
(
AOA)
are
deemed
to
meet
the
requirements
in
the
CoPs,
and
therefore,
are
not
routinely
surveyed
for
compliance
by
the
SAs.
However,
all
Medicare
and
Medicaid
participating
hospitals
are
required
to
be
in
compliance
with
our
CoPs
regardless
of
their
accreditation
status.
B.
Patient
Safety
and
Medical
Errors
In
1999,
the
Institute
of
Medicine
(
IOM)
published
a
report
entitled
``
To
Err
is
Human:
Building
a
Safer
Health
System,''
which
highlighted
patient
injuries
associated
with
medical
errors.
In
this
report,
the
IOM
defined
an
error
as
the
following:
``
An
error
is
defined
as
the
failure
of
a
planned
action
to
be
completed
as
intended
or
the
use
of
a
wrong
plan
to
achieve
an
aim.''
The
IOM
report
also
indicated
that
an
estimated
44,000
to
98,000
Americans
die
annually
as
a
result
of
preventable
medical
errors.
The
results
of
the
report
have
generated
substantial
media,
public,
Congressional,
and
Departmental
concerns
regarding
patients
health
and
safety.
As
recommended
by
the
IOM,
the
Quality
Interagency
Coordination
Task
Force
(
QuIC),
evaluated
and
responded
to
the
recommendations
in
the
IOM
report
with
a
strategy
to
identify
patient
safety
issues
and
to
reduce
the
number
of
errors
by
50
percent
over
the
next
5
years.
In
an
effort
to
thoroughly
consider
all
of
the
relevant
issues
related
to
medical
errors,
the
QuIC
expanded
the
IOM's
definition
to
read
as
follows:
``
An
error
is
defined
as
the
failure
of
a
planned
action
to
be
completed
as
intended
or
the
use
of
a
wrong
plan
to
achieve
an
aim.
Errors
can
include
problems
in
practice,
products,
procedures,
and
systems.''
We
have
adopted
the
QuIC
revised
definition
of
an
error.
Accordingly,
the
QAPI
CoP
has
been
separated
from
the
larger
set
of
CoPs
and
published
in
an
accelerated
timeframe
because
it
provides
the
framework
to
implement
the
Administration's
initiatives
designed
to
help
distinguish
and
avoid
mistakes
in
the
healthcare
delivery
system.
In
addition,
we
are
requiring
that
a
hospital's
QAPI
program
be
an
ongoing
program
that
shows
measurable
improvement
in
indicators
for
which
there
is
evidence
that
they
will
improve
health
outcomes
and
identify
and
reduce
medical
errors.
The
remaining
provisions
of
the
hospital
CoPs
will
be
published
at
a
later
date.
Many
people
believe
that
medical
errors
involve
medication
(
for
example,
an
incorrect
or
improper
dosage
of
medicine)
or
surgical
errors
(
for
example,
incorrect
site
amputation).
However,
there
are
many
other
types
of
medical
errors
including
 
 
Diagnostic
errors
(
for
example,
misdiagnoses
leading
to
an
incorrect
choice
of
therapy
or
treatment,
failure
to
use
an
indicated
diagnostic
test,
misinterpretation
of
test
results,
and
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