Friday,

August
9,
2002
Part
II
Environmental
Protection
Agency
40
CFR
Part
194
Criteria
for
the
Certification
and
Recertification
of
the
Waster
Isolation
Pilot
Plant's
Compliance
With
the
Disposal
Regulations;
Alternative
Provisions;
Proposed
Rule
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Federal
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/
Vol.
67,
No.
154
/
Friday,
August
9,
2002
/
Proposed
Rules
ENVIRONMENTAL
PROTECTION
AGENCY
40
CFR
Part
194
[FRL–
7255–
4]

RIN
2060–
AJ07
Criteria
for
the
Certification
and
Recertification
of
the
Waste
Isolation
Pilot
Plant's
Compliance
with
the
Disposal
Regulations;
Alternative
Provisions
AGENCY:
Environmental
Protection
Agency
(EPA).
ACTION:
Proposed
rule.

SUMMARY:
The
Environmental
Protection
Agency
(``
EPA,
''
or
``
the
Agency''
or
``
we'')
is
proposing
to
revise
the
``
Criteria
for
the
Certification
and
Recertification
of
the
Waste
Isolation
Pilot
Plant's
Compliance
with
the
Disposal
Regulations,
''
which
are
used
to
determine
whether
the
Department
of
Energy's
Waste
Isolation
Pilot
Plant
(``
WIPP'')
will
comply
with
EPA's
``
Environmental
Radiation
Protection
Standards
for
Management
and
Disposal
of
Spent
Nuclear
Fuel,
High­
Level
and
Transuranic
Radioactive
Wastes.
''
The
following
proposed
revisions
are
included
in
today's
action:
addition
of
a
mechanism
to
address
minor
changes
to
the
provisions
of
the
Compliance
Criteria;
changes
to
the
approval
process
for
waste
characterization
programs
at
Department
of
Energy
transuranic
sites;
changes
to
allow
for
the
submission
of
copies
of
compliance
applications
and
reference
materials
in
alternative
format;
and
replacement
of
the
term
``
process
knowledge''
with
``
acceptable
knowledge.
''
The
proposed
changes
do
not
lessen
the
requirements
for
complying
with
the
Compliance
Criteria.
Moreover,
these
changes
will
have
no
effect
on
the
technical
approach
that
EPA
employs
when
conducting
independent
inspections
of
the
waste
characterization
capabilities
at
DOE
waste
generator
sites.
EPA
is
conducting
this
proposed
action
in
accordance
with
the
procedures
for
substituting
alternative
provisions
of
the
Compliance
Criteria.
Today's
notice
marks
the
beginning
of
a
120­
day
public
comment
period
on
this
proposed
action.
DATES:
EPA
requests
comments
on
all
aspects
of
these
proposed
revisions.
If
you
wish
to
submit
comments
on
this
proposal,
you
must
do
so
by
December
9,
2002.
ADDRESSES:
Send
your
comments
to:
Air
Docket,
Room
M–
1500,
U.
S.
Environmental
Protection
Agency,
401
M
Street,
SW.,
Mail
Code
6102,
Washington,
DC
20460,
Attention
Docket
ID
No.
OAR–
2002–
0005.
Comments
may
be
submitted
electronically,
by
mail,
by
facsimile,
or
through
hand
delivery/
courier.
Follow
the
detailed
instructions
as
provided
in
Section
B
of
the
SUPPLEMENTARY
INFORMATION
section.
FOR
FURTHER
INFORMATION
CONTACT:
Agnes
Ortiz;
telephone
number:
(202)
564–
9310;
postal
address:
Radiation
Protection
Division,
Mail
Code
6608J,
U.
S.
Environmental
Protection
Agency,
1200
Pennsylvania
Avenue,
NW.,
Washington,
DC,
20460.
SUPPLEMENTARY
INFORMATION:

General
Information
A.
How
Can
I
Get
Copies
of
This
Document
and
Other
Related
Information?
EPA
has
established
an
official
public
docket
for
this
action
under
Docket
ID
No.
OAR–
2002–
0005.
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:
Air
Docket,
Room
M–
1500,
U.
S.
Environmental
Protection
Agency,
401
M
Street,
SW.,
Mail
Code
6102,
Washington,
DC
20460.
This
Docket
Facility
is
open
from
8:
30am–
5
pm,
Monday
through
Friday,
excluding
legal
holidays.
The
Air
Docket
telephone
number
is
202–
260–
7548.
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
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
in
Section
B
under
General
Information.
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
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,
by
facsimile,
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
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Federal
Register
/
Vol.
67,
No.
154
/
Friday,
August
9,
2002
/
Proposed
Rules
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.
However,
late
comments
may
be
considered
if
time
permits.
If
you
wish
to
submit
CBI
or
information
that
is
otherwise
protected
by
statute,
please
follow
the
instructions
in
Section
C
under
General
Information.
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
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
submitter
of
the
comment
and
allows
EPA
to
contact
you
in
case
EPA
cannot
read
your
comment
due
to
technical
difficulties
or
needs
further
information
on
the
substance
of
your
comment.
EPA's
policy
is
that
EPA
will
not
edit
your
comment,
and
any
identifying
or
contact
information
provided
in
the
body
of
a
comment
will
be
included
as
part
of
the
comment
that
is
placed
in
the
official
public
docket,
and
made
available
in
EPA's
electronic
public
docket.
If
EPA
cannot
read
your
comment
due
to
technical
difficulties
and
cannot
contact
you
for
clarification,
EPA
may
not
be
able
to
consider
your
comment.
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
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.
OAR–
2002–
0005.
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.
Comments
may
be
sent
by
electronic
mail
(e­
mail)
to
a­
and­
r­
docket@
epa.
gov
Attention
Docket
ID
No.
OAR–
2002–
0005.
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.
You
may
submit
comments
on
a
disk
or
CD
ROM
that
you
mail
to
the
mailing
address
identified
in
Section
A
under
General
Information.
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:
Air
Docket,
Room
M–
1500,
U.
S.
Environmental
Protection
Agency,
401
M
Street,
SW.,
Mail
Code
6102,
Washington,
DC
20460,
Attention
Docket
ID
No.
OAR–
2002–
0005.

3.
By
Hand
Delivery
or
Courier
Deliver
your
comments
to:
Air
Docket,
Room
M–
1500,
U.
S.
Environmental
Protection
Agency,
401
M
Street,
SW.,
Mail
Code
6102,
Washington,
DC
20460,
Attention
Docket
ID
No.
OAR–
2002–
0005.
Such
deliveries
are
only
accepted
during
the
Docket's
normal
hours
of
operation
as
identified
in
Section
A
under
General
Information.

4.
By
Facsimile
Fax
your
comments
to:
(202)
260–
4400,
Attention
Docket
ID.
No.
OAR–
2002–
0005.

C.
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
identified
in
the
FOR
FURTHER
INFORMATION
CONTACT
section.

D.
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
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
your
estimate.
5.
Provide
specific
examples
to
illustrate
your
concerns.
6.
Offer
alternatives.
7.
Make
sure
to
submit
your
comments
by
the
comment
period
deadline
identified.
8.
To
ensure
proper
receipt
by
EPA,
identify
the
appropriate
docket
identification
number
in
the
subject
line
on
the
first
page
of
your
response.
It
would
also
be
helpful
if
you
provided
the
name,
date,
and
Federal
Register
citation
related
to
your
comments.

Abbreviations
Used
in
This
Document
AK—
Acceptable
knowledge
Am—
Americium
APA—
Administrative
Procedure
Act
ASME—
American
Society
of
Mechanical
Engineers
BID—
Background
information
document
CAR—
Corrective
Action
Required
CARD—
Compliance
Application
Review
Document
CBFO—
Carlsbad
Field
Office
CCA—
Compliance
Certification
Application
CFR—
Code
of
Federal
Regulations
CH—
Contact
handled
Cs—
Cesium
DOE—
Department
of
Energy
EEG—
Environmental
Evaluation
Group
EPA—
Environmental
Protection
Agency
INEEL—
Idaho
National
Energy
and
Engineering
Laboratory
LANL—
Los
Alamos
National
Laboratory
NDA—
Nondestructive
Assay
NPRM—
Notice
of
Proposed
Rulemaking
NTS—
Nevada
Test
Site
NQA—
Nuclear
Quality
Assurance
ORNL—
Oak
Ridge
National
Laboratory
PK—
Process
knowledge
Pu—
Plutonium
QA—
Quality
assurance
QAPP—
Quality
Assurance
Project
Plan
QAPjP—
Quality
Assurance
Project
Plan
RC—
Radiochemistry
RCRA—
Resource
Conservation
Recovery
Act
RFETS—
Rocky
Flats
Environmental
Technology
Site
RTR—
Real­
time
radiography
SRS—
Savannah
River
Site
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/
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9,
2002
/
Proposed
Rules
Sr—
Strontium
TRU—
Transuranic
U—
Uranium
VE—
Visual
inspection
WAC—
Waste
Acceptance
Criteria
WAP—
Waste
Acceptance
plan
WC—
Waste
characterization
WIPP—
Waste
Isolation
Pilot
Plant
WIPP
LWA—
WIPP
Land
Withdrawal
Act
WWIS—
WIPP
Waste
Information
System
Table
of
Contents
I.
What
Is
WIPP?
II.
What
Is
the
Purpose
of
Today's
Proposed
Action?
III.
How
Is
EPA
Revising
the
Process
for
Establishing
Alternative
Provisions
in
§
194.6?
A.
What
Are
the
Current
Requirements
in
§
194.6?
B.
What
Changes
Are
Proposed
for
§
194.6?
C.
How
Has
EPA
Addressed
the
Alternative
Provision
Analysis
Required
by
§
194.6?
IV.
How
Is
EPA
Revising
the
Approval
Process
for
Waste
Shipment
from
Waste
Generator
Sites
for
Disposal
at
WIPP
in
§
194.8(
b)?
A.
What
Are
the
Current
Requirements
in
§
194.8(
b)?
B.
What
Are
the
Proposed
Changes
to
§
194.8(
b)?
C.
How
Has
EPA
Addressed
the
Alternative
Provision
Analysis
Required
by
§
194.6?
V.
How
Is
EPA
Revising
the
Submission
of
Compliance
Applications
and
Reference
Materials
Requirements
in
§§
194.12
and
194.13?
A.
What
Are
the
Current
Requirements
in
§§
194.12
and
194.13?
B.
What
Are
the
Proposed
Changes
to
§§
194.12
and
194.13?
C.
How
Has
EPA
Addressed
the
Alternative
Provision
Analysis
Required
by
§
194.6?
VI.
How
Is
EPA
Revising
the
Waste
Characterization
Requirements
in
§
194.24(
c)(
3)?
A.
What
Are
the
Current
Waste
Characterization
Requirements
in
§
194.24(
c)(
3)?
B.
What
Are
the
Proposed
Changes
to
§
194.24(
c)(
3)?
C.
How
Has
EPA
Addressed
the
Alternative
Provision
Analysis
Required
by
§
194.6?
VII.
Administrative
Reuquirments
A.
Executive
Order
12866
B.
Regulatory
Flexibility
Act
C.
Paperwork
Reduction
Act
D.
Unfunded
Mandates
Reform
Act
E.
Executive
Order
12898
F.
National
Technology
Transfer
&
Advancement
Act
of
1995
G.
Executive
Order
13045:
Children's
Health
Protection
H.
Executive
Order
13132:
Federalism
I.
Executive
Order
13175:
Consultation
and
Coordination
With
Indian
Tribal
Governments
J.
Executive
Order
13211:
Energy
Effects
I.
What
Is
WIPP?
The
Waste
Isolation
Pilot
Plant
(``
WIPP'')
is
a
disposal
system
for
transuranic
radioactive
waste.
Developed
by
the
Department
of
Energy
(``
DOE''
or
``
the
Department''),
the
WIPP
is
located
near
Carlsbad
in
southeastern
New
Mexico.
Transuranic
(TRU)
radioactive
wastes
are
emplaced
2,150
feet
underground
in
an
ancient
layer
of
salt
that
will
eventually
``
creep''
and
encapsulate
the
waste
containers.
The
WIPP
has
a
total
capacity
of
6.2
million
cubic
feet
of
TRU
waste.
Development
and
construction
of
the
WIPP
was
authorized
under
Section
213
of
the
Department
of
Energy
National
Security
and
Military
Applications
of
Nuclear
Energy
Authorization
Act
of
1980
(Public
Law
No.
96–
164,
93
U.
S.
Stat.
1259,
1265).
WIPP
was
authorized
as
a
defense
activity
of
the
Department
of
Energy
to
demonstrate
the
safe
disposal
of
radioactive
wastes
resulting
from
the
defense
activities
and
programs
of
the
United
States.
Pursuant
to
Section
7
of
the
WIPP
Land
Withdrawal
Act
(Public
Law
No.
102–
579,
as
amended
by
Public
Law
No.
104–
201)
(WIPP
LWA),
disposal
operations
at
WIPP
are
limited
to
a
total
volume
of
6.2
million
cubic
feet
of
transuranic
radioactive
waste.
Section
2(
18)
of
the
WIPP
LWA
defines
TRU
waste
as
waste
containing
more
than
100
nanocuries
of
alphaemitting
transuranic
isotopes
per
gram
of
waste,
with
half­
lives
greater
than
20
years.
This
definition
excludes
highlevel
radioactive
waste,
waste
determined
by
DOE
with
the
concurrence
of
EPA
to
not
need
such
isolation,
or
waste
that
the
Nuclear
Regulatory
Commission
has
approved
for
disposal
on
a
case­
by­
case
basis,
consistent
with
NRC
regulations.
Most
TRU
waste
proposed
for
disposal
at
WIPP
consists
of
items
that
have
become
contaminated
as
a
result
of
activities
associated
with
the
production
of
nuclear
weapons
(or
with
the
cleanup
of
nuclear
weapons
production
facilities),
such
as,
rags,
equipment,
tools,
protective
gear,
and
sludges.
Some
TRU
waste
is
contaminated
with
hazardous
wastes
regulated
under
the
Resource
Conservation
and
Recovery
Act
(42
U.
S.
C.
6901–
6992k)(
RCRA).
The
waste
proposed
for
disposal
at
WIPP
is
currently
stored
at
Federal
facilities
across
the
United
States,
including
locations
in
Colorado,
Idaho,
New
Mexico,
Nevada,
Ohio,
South
Carolina,
Tennessee,
and
Washington.
Section
8(
c)
of
the
WIPP
LWA
required
EPA
to
promulgate
criteria,
pursuant
to
Section
4
of
the
Administrative
Procedure
Act
(APA),
for
EPA's
certification
of
the
WIPP's
compliance
with
the
radioactive
waste
disposal
regulations
at
40
CFR
Part
191.
On
February
9,
1996,
EPA
published
the
final
``
Criteria
for
the
Certification
and
Re­
Certification
of
the
Waste
Isolation
Pilot
Plant's
Compliance
With
the
40
CFR
Part
191
Disposal
Regulations'
(61
FR
5224)
(Compliance
Criteria).
Section
8(
d)
of
the
WIPP
LWA
set
forth
specific
procedures
governing
the
certification
of
the
WIPP.
Section
8(
d)(
1)
required
DOE
to
submit
a
complete
compliance
application
by
October
31,
1996.
Section
8(
d)(
1)
also
provided
that
EPA
had
the
authority
to
request
any
additional
information
necessary
for
the
Agency's
determination
of
compliance.
Section
8(
d)(
2)
required
that
EPA
complete
its
certification
decision
within
one
year
of
receipt
of
the
DOE's
application.
(EPA
clarified
at
§
194.11
of
the
Compliance
Criteria
that,
consistent
with
legislative
intent,
EPA's
certification
decision
would
be
due
within
one
year
of
receipt
of
a
complete
compliance
application.)
EPA
determined
DOE's
compliance
application
to
be
complete
on
May
22,
1997
(62
FR
27996).
EPA
determined
on
May
18,
1998,
that
DOE
had
demonstrated
that
the
WIPP
will
comply
with
EPA's
radioactive
waste
disposal
regulations
at
Subparts
B
and
C
of
40
CFR
part
191.
EPA's
certification
determination
permitted
the
WIPP
to
begin
accepting
transuranic
waste
for
disposal,
provided
that
other
applicable
environmental
regulations
were
met
and
once
a
30­
day
statutory
waiting
period
had
elapsed.
EPA
based
its
decision
on
a
thorough
review
of
all
the
information
submitted
by
DOE,
independent
technical
analyses,
and
all
significant
public
comments
submitted
during
a
nominal
120­
day
comment
period.
EPA's
certification,
however,
was
subject
to
four
specific
conditions.
Thus,
EPA
amended
the
WIPP
compliance
criteria
at
40
CFR
part
194
to
include
an
appendix
setting
forth
the
four
conditions
on
the
certification
of
compliance.
These
conditions
related
to
(1)
design
of
the
panel
closure
system
(which
is
intended
over
the
long
term
to
block
brine
flow
between
waste
panels
in
the
WIPP);
(2)
and
(3)
activities
conducted
at
waste
generator
sites
that
produce
the
transuranic
waste
proposed
for
disposal
in
the
WIPP
(specifically
with
respect
to
quality
assurance
and
waste
characterization);
and
(4)
passive
institutional
controls.
Subsequent
to
the
initial
certification,
EPA
continues
to
have
an
oversight
role
at
the
WIPP.
First,
Section
9
of
the
WIPP
LWA
requires
that
DOE
submit
biennial
documentation
of
continued
compliance
with
specified
laws,
regulations,
and
permit
requirements.
Second,
§
194.4
of
the
Compliance
Criteria
requires
that
DOE
submit
periodic
reports
on
any
activities
or
conditions
at
the
WIPP
that
differ
significantly
from
the
information
contained
in
the
most
recent
compliance
application.
EPA
may
also,
at
any
time,
request
additional
information
from
DOE
regarding
the
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Federal
Register
/
Vol.
67,
No.
154
/
Friday,
August
9,
2002
/
Proposed
Rules
WIPP
to
determine
if
regulatory
action
is
required
concerning
the
certification.
Third,
Section
8(
f)
of
the
WIPP
LWA
requires
at
least
five
years
after
the
initial
certification
and
every
five
years
thereafter,
that
DOE
submit
to
EPA
and
the
State
of
New
Mexico
documentation
of
continued
compliance
with
the
Part
191
radioactive
waste
disposal
regulations.
In
accordance
with
§
194.64
of
the
Compliance
Criteria,
documentation
of
continued
compliance
will
be
made
available
in
EPA's
dockets,
and
the
public
will
be
provided
at
least
a
30­
day
period
during
which
to
submit
comments.
EPA's
decision
on
recertification
will
be
announced
in
the
Federal
Register.

II.
What
Is
the
Purpose
of
Today's
Proposed
Action?
EPA
proposes
to
revise
certain
provisions
of
the
Compliance
Criteria
at
40
CFR
part
194.
Specifically,
EPA
is
proposing
to
(1)
revise
the
process
for
establishing
``
alternative
provisions''
in
§
194.6;
(2)
revise
the
approval
process
in
§
194.8
for
waste
characterization
processes
at
TRU
waste
generator
sites
for
disposal
at
WIPP;
(3)
revise
the
requirements
in
§§
194.12
and
194.13
for
submission
of
compliance
applications
and
reference
materials;
and
(4)
change
the
term
``
process
knowledge''
to
``
acceptable
knowledge''
in
§
194.24(
c)(
3).
The
proposed
revisions
are
intended
to
ensure
that
40
CFR
Part
194
remains
comprehensive,
appropriate,
and
based
upon
current
knowledge
and
information.
The
Agency
solicits
comments
on
this
proposal.
Section
194.6
of
the
Compliance
Criteria
imposes
specific
requirements
for
substitution
of
``
alternative
provisions''
of
the
Criteria.
Such
alternative
provisions
must
be
promulgated
pursuant
to
Section
4
of
the
APA.
Also,
in
proposing
the
alternative
provisions
EPA
must
describe
how
the
proposed
changes
comport
with
the
radioactive
waste
disposal
regulations
at
40
CFR
part
191,
the
reasons
why
the
existing
provisions
appear
inappropriate,
and
the
costs,
risks,
and
benefits
of
compliance
with
the
new
provisions.
Finally,
EPA
must
provide
for
a
public
comment
period
of
120
days
and
hearings
in
New
Mexico,
and
fully
consider
the
public
comments
that
are
received.
Today's
Notice
of
Proposed
Rulemaking
(NPRM)
is
organized
so
that,
for
each
of
the
proposed
revisions,
the
preamble
addresses
the
following
topics:
A.
What
are
the
current
requirements?;
B.
What
are
the
proposed
changes?;
and
C.
How
has
EPA
addressed
the
Alternative
Provision
Analysis
required
by
§
194.6?
III.
How
Is
EPA
Revising
the
Process
for
Establishing
Alternative
Provisions
in
§
194.6?

A.
What
Are
the
Current
Requirements
in
§
194.6?

Section
194.6
establishes
procedures
applicable
to
substitution
of
alternative
provisions
of
the
Compliance
Criteria.
As
discussed
above,
such
substitutions
require
notice
and
comment
rulemaking,
pursuant
to
Section
4
of
the
APA.
In
addition,
§
194.6
stipulates
that
EPA's
NPRM
address
specific
aspects
of
the
proposed
substitution,
include
a
public
comment
period
of
at
least
120
days,
and
public
hearings
in
New
Mexico.

B.
What
Changes
Are
Proposed
for
§
194.6?

EPA
is
proposing
to
revise
§
194.6
to
add
a
rulemaking
process
for
substituting
``
minor
alternative
provisions''
of
the
Compliance
Criteria.
The
process
for
substituting
``
minor
alternative
provisions''
would
include:
(1)
Rulemaking
pursuant
to
Section
4
of
the
APA;
(2)
publication
of
the
proposed
changes
in
the
Federal
Register,
together
with
information
describing
how
the
changes
conform
with
the
disposal
regulations,
the
reasons
why
the
changes
are
needed,
and
the
benefits
of
compliance
with
the
minor
changes;
(3)
a
public
comment
period
of
at
least
30
days;
and
(4)
publication
in
the
Federal
Register
of
the
final
notice
after
public
comments
received
have
been
fully
considered.
EPA
is
also
proposing
to
add
the
following
definition
of
``
minor
alternative
provision''
to
§
194.2:
``
minor
alternative
provision
means
an
alternative
provision
to
the
Compliance
Criteria
that
clarifies
a
regulatory
provision,
or
does
not
substantively
alter
the
existing
regulatory
requirement.
''

C.
How
Has
EPA
Addressed
the
Alternative
Provision
Analysis
Required
by
§
194.6?

The
Agency
wants
to
have
the
ability
to
make
insignificant
changes
to
the
Compliance
Criteria
in
an
expedited
time
frame
to
facilitate
WIPP's
continued
compliance
with
our
regulations.
The
provisions
for
substituting
minor
alternative
provisions
could,
for
example,
be
used
to
modify
the
Compliance
Criteria
to
change
regulatory
terminology
to
more
clearly
express
the
Agency's
intended
meaning
or
to
clarify
expectations.
Substitution
of
``
minor
alternative
provisions''
would
not
in
any
way
substantively
modify
the
Compliance
Criteria
requirements.
1.
Why
Do
the
Existing
Provisions
in
§
194.6
Appear
Inappropriate?

In
certain
specific
contexts,
discussed
below,
EPA
considers
the
existing
provisions
to
be
inappropriate
because
they
are
unnecessarily
stringent.
When
§
194.6
was
promulgated,
EPA
was
beginning
the
process
of
formal
regulation
of
the
WIPP.
EPA
had
not
yet
even
received
the
DOE's
compliance
certification
application.
EPA
now
has
engaged
in
close
regulatory
oversight
of
the
WIPP
for
over
six
years.
EPA
has
engaged
in
post­
certification
oversight
of
the
WIPP
for
almost
four
years.
During
that
time,
EPA
has
gained
substantial
experience
and
insight
into
this
regulatory
process.
While
§
194.6,
as
originally
drafted,
was
intended
to
address
all
changes
to
the
Compliance
Criteria,
EPA
now
realizes
that
there
may
be
modifications
to
the
Compliance
Criteria
that,
while
useful,
are
not
sufficiently
significant
to
require
the
stringent
procedures
currently
set
forth
in
§
194.6.
EPA's
oversight
experience
indicates
that
minor
revisions
to
the
Compliance
Criteria
requirements
may
improve
implementation
and
consistency
in
regulatory
compliance.
EPA
believes
that
today's
proposal
includes
several
examples
of
minor
revisions
that
would
be
appropriately
addressed
by
a
less
stringent
process
than
currently
available
under
§
194.6.
For
example,
EPA
is
proposing
to
replace
the
term
``
process
knowledge''
in
§
194.24(
c)(
3)
with
the
term
``
acceptable
knowledge''
(see
section
VI
of
the
preamble).
This
minor
revision
is
intended
to
acknowledge
that
``
acceptable
knowledge''
is
the
term
EPA
has
used
consistently
since
the
WIPP
was
certified.
EPA
is
also
proposing
to
permit
DOE
to
submit
fewer
printed
recertification
compliance
applications
than
currently
required
in
the
Compliance
Criteria.
These
proposed
revisions
do
not
substantively
alter
the
intent
or
the
approach
to
verifying
compliance
with
the
waste
characterization
requirements
in
any
way,
but
improve
the
clarity
of
and
more
clearly
reflect
the
intent
of
the
Compliance
Criteria.
Such
minor
revisions
should
not
require
a
120­
day
public
comment
period,
nor
necessitate
a
public
hearing.
We
propose
that
a
30­
day
comment
period
is
sufficient
for
the
public
to
provide
the
Agency
with
relevant
input
on
such
minor
revisions
of
the
Compliance
Criteria.
In
addition
to
the
publication
of
the
NPRM
in
the
Federal
Register,
EPA
intends
to
announce
the
proposal
on
the
Agency's
website
and
place
all
relevant
supporting
materials
in
the
Agency's
public
docket.
For
all
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Federal
Register
/
Vol.
67,
No.
154
/
Friday,
August
9,
2002
/
Proposed
Rules
1
The
term
``
waste
characterization,
''
as
we
use
it
with
regard
to
the
WIPP
repository
and
the
numerous
waste
generator
sites,
encompasses
a
wide
array
of
activities,
all
of
which
serve
to
determine
what
is
inside
any
given
container
of
transuranic
waste
and
to
control
that
container
until
DOE
places
it
in
the
WIPP
for
disposal.
Stated
generally,
the
Compliance
Criteria
for
waste
characterization
in
§
194.24
require
DOE
to:
Determine
which
waste
components
(such
as
ferrous
metals)
and
characteristics
(e.
g.,
acidity)
are
relevant
to
the
WIPP's
performance;
show
how
they
affect
performance;
and
identify
and
track
significant
waste
components
as
they
are
placed
in
the
WIPP.
The
last
of
these
activities
is
the
subject
of
§
194.8(
b).
The
waste
characterization
requirements
are
discussed
in
great
detail
in
the
preamble
to
the
May
18,
1998,
Certification
Decision
final
rule.
(63
FR
27389–
27393)
2
The
term
``
waste
stream''
means
wastes
derived
from
a
single
process
or
activity
that
are
similar
in
material,
physical
form,
isotopic
makeup,
and
hazardous
constituents.
(Certification
Decision
proposed
rule
62
FR
58813.)
3
Process
knowledge
(``
PK'')
refers
to
knowledge
of
waste
characteristics
derived
from
information
generated
contemporaneously
with
the
waste
on
the
materials
or
processes
used
to
generate
the
waste.
This
information
may
include
administrative,
procurement,
and
quality
control
documentation
associated
with
the
generating
process,
or
past
sampling
or
analytical
data.
Usually,
the
major
elements
of
process
knowledge
include
information
about
the
process
used
to
generate
the
waste,
material
inputs
to
the
process,
and
the
time
period
during
which
the
waste
was
generated.
(Certification
Decision
final
rule
63
FR
27390.)
4
The
system
of
controls
for
waste
characterization
includes,
but
is
not
limited
to:
Measurement,
sampling,
chain
of
custody
records,
record
keeping
systems,
waste
loading
schemes
used,
and
other
documentation.
40
CFR
194.24(
c)(
4).
5
The
term
``
waste
component''
means
``
an
ingredient
of
the
total
inventory
of
the
waste
that
influences
a
waste
characteristic''.
40
CFR
194.2.
The
term
``
waste
characteristic''
means
``
a
property
of
the
waste
that
has
an
impact
on
the
containment
of
waste
in
the
disposal
system''.
40
CFR
194.2.
The
important
waste
components
with
regard
to
the
WIPP's
compliance
are
radionuclides,
ferrous
and
nonferrous
metals,
organic
materials
such
as
paper
and
rubber,
and
free
water.
6
The
WWIS
is
described
in
Chapter
4
(page
4–
35)
of
the
WIPP
Compliance
Certification
Application
as
``
a
computerized
data
management
system
used
*
*
*
to
gather,
store,
and
process
information
pertaining
to
transuranic
(TRU)
waste
destined
for
or
disposed
at
the
WIPP.
''
[Air
Docket
A–
93–
02,
Item
II–
G–
1.]
substitutions
of
alternative
provisions
that
are
not
minor
alternative
provisions,
as
defined
in
this
document
(for
example,
the
addition,
deletion,
or
significant
revision
of
a
requirement),
EPA
will
continue
to
comply
with
the
current
requirements
of
§
194.6.
EPA
defines
a
``
minor
alternative
provision''
as
an
alternative
provision
that
``
clarifies
a
regulatory
provision,
or
does
not
substantively
alter
the
existing
regulatory
requirement.
''
Thus,
revisions
that
do
not
alter
the
intent
or
the
approach
to
verifying
compliance
of
an
existing
regulatory
requirement
are
considered
to
constitute
minor
alternative
provisions.
For
example,
today's
proposed
revisions
to
§§
194.2,
194.12,
194.13,
and
194.24(
c)(
3)
are
examples
of
minor
changes.
The
proposed
revisions
to
§§
194.6
and
194.8(
b),
however,
are
examples
of
nonminor
alternative
provisions.

2.
How
Do
the
Proposed
Changes
in
§
194.6
Comport
with
40
CFR
part
191?
The
proposed
changes
for
§
194.6
comport
fully
with
the
radioactive
waste
disposal
regulations
at
40
CFR
part
191.
The
WIPP
must
comply
with
EPA's
radioactive
waste
disposal
regulations
located
at
Subparts
B
and
C
of
40
CFR
part
191.
These
regulations
limit
the
amount
of
radioactive
materials
that
may
escape
from
a
disposal
facility,
and
are
intended
to
protect
individuals
and
ground
water
resources
from
dangerous
levels
of
radioactive
contamination.
The
Compliance
Criteria
implement
and
interpret
the
general
disposal
regulations
specifically
for
the
WIPP,
and
constitute
the
basis
on
which
EPA's
certification
decision
was
made.
Section
194.6
was
included
in
the
Compliance
Criteria
to
ensure
that
any
amendments
to
the
Criteria
would
be
effected
through
the
same
rigorous
rulemaking
procedure
under
which
the
original
Criteria
were
promulgated.
The
proposed
amendment
to
§
194.6
would
not
substantively
alter
the
scope
of
those
requirements.
The
Compliance
Criteria
would
continue
to
include
the
current
process
established
in
§
194.6
to
revise
40
CFR
part
194.
The
principle
difference
between
the
existing
and
proposed
new
provisions
is
the
addition
of
a
revision
process
for
minor
changes.
This
new
revision
process
would
not
substantively
affect
the
Compliance
Criteria's
implementation
of
40
CFR
part
191.

3.
What
Are
the
Costs,
Risks,
and
Benefits
of
Compliance
with
the
New
Provisions
in
§
194.6
?
As
part
of
our
implementation
efforts
for
the
1998
certification
decision,
we
will
continue
to
develop
revisions
to
the
Compliance
Criteria,
as
we
deem
necessary,
based
on
lessons
learned
from
our
oversight
experience.
This
is
our
first
revision
to
the
Compliance
Criteria
since
the
initial
certification
decision
in
1998.
There
will
be
no
increased
costs
for
EPA
as
a
result
of
the
proposed
revision.
Rather,
EPA
believes
that
it
is
reasonable
to
expect
significant
savings
over
the
period
of
active
regulation
of
the
WIPP.
The
proposed
revision
will
shorten
rulemakings
where
appropriate
and
eliminate
a
requirement
for
public
hearings
in
instances
where
the
impact
of
changes
would
be
small
and
public
interest
may
reasonably
be
expected
to
be
low.
Moreover,
EPA
does
not
expect
DOE
to
incur
additional
costs,
since
the
implementation
of
§
194.6
is
solely
EPA's
responsibility.
EPA
does
not
anticipate
any
increased
risks
related
to
the
implementation
of
the
proposed
revision.
Rather,
we
anticipate
that
EPA's
regulatory
activities
will
become
more
efficient,
and
that
EPA
will
be
able
to
implement
necessary
minor
revisions
to
the
Compliance
Criteria
that
are
designed
to
improve
implementation
and
consistency
in
regulatory
compliance.
The
benefits
of
the
proposed
revision
to
§
194.6
are
several.
First,
the
Agency,
would
be
able
to
make
minor
revisions
to
the
Compliance
Criteria
in
a
timely
fashion.
Making
these
types
of
revisions
in
a
shorter
timeframe
will
enhance
compliance
with
40
CFR
part
194.
Second,
the
public
will
continue
to
have
an
opportunity
to
review
and
comment
on
proposed
minor
revisions.
Third,
the
Agency
will
continue
to
hold
public
hearings
in
New
Mexico
for
major
revisions
to
the
Compliance
Criteria.
Fourth,
DOE
will
be
able
to
implement
minor
revisions
faster,
therefore,
this
proposed
revision
will
contribute
to
safer
and
more
cost
effective
disposal
of
radioactive
wastes.

IV.
How
Is
EPA
Revising
the
Approval
Process
for
Waste
Shipment
From
Waste
Generator
Sites
for
Disposal
at
WIPP
in
§
194.8(
b)?

A.
What
Are
the
Current
Requirements
in
§
194.8(
b)?

Section
194.8(
b)
describes
the
process
by
which
EPA
reviews
and
approves
WIPP­
related
waste
characterization
activities
1
at
DOE
transuranic
waste
sites.
At
present,
for
each
waste
stream
or
group
of
waste
streams
2
other
than
those
approved
in
our
final
certification
decision,
DOE
must
provide
information
on
how
a
waste
site
uses
process
knowledge
3
to
characterize
those
streams
(§
194.8(
b)(
1)(
i)).
The
DOE
also
must
implement
a
system
of
controls
4
that
confirms
that
the
total
quantity
of
important
waste
components
5
in
the
WIPP
does
not
exceed
limits
established
by
the
final
Certification
Decision
(§
194.8(
b)(
1)(
ii)).
In
order
to
show
EPA
that
the
system
of
controls
is
effective,
DOE
must
demonstrate
each
TRU
waste
site's
measurement
techniques
and
control
methods,
and
must
demonstrate
that
data
about
waste
components
are
properly
transferred
from
the
waste
sites
to
the
WIPP
Waste
Information
System
(WWIS).
6
To
evaluate
compliance
with
the
above­
mentioned
requirements,
we
must
inspect
and
approve
each
DOE
transuranic
waste
site
that
wishes
to
ship
waste
to
the
WIPP
for
disposal.
We
must
inspect
the
site's
use
of
process
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Federal
Register
/
Vol.
67,
No.
154
/
Friday,
August
9,
2002
/
Proposed
Rules
7
EPA
specifically
addressed
public
comments
concerning
the
importance
of
Condition
3
in
EPA's
Response
to
Comments
Document
for
the
Certification
Decision.
See
EPA
Air
Docket
A–
93–
02,
Item
V–
C–
1,
pages
2–
5
to
2–
9.
knowledge
and
witness
a
demonstration
of
waste
characterization
processes
for
each
waste
stream,
or
group
of
waste
streams,
that
the
site
intends
to
ship.
If
a
site
receives
our
approval
to
ship
a
single
waste
stream,
that
site
cannot
ship
a
different
waste
stream
until
we
perform
an
additional
inspection
under
authority
of
§
194.8(
b).
EPA
imposed
these
requirements
as
a
condition
of
the
certification
to
ensure
full
compliance
with
the
waste
characterization
regulations
at
§
194.24(
c).
Once
DOE
has
submitted
waste
characterization
program
plans
for
a
given
site,
we
place
the
plans
in
our
docket
and
publish
one
or
more
notices
in
the
Federal
Register
that
announce
the
availability
of
the
plans
and
our
intent
to
inspect
the
site
on
a
specific
date
(§
194.8(
b)(
2)).
We
also
open
a
comment
period
of
at
least
30
days
for
others
to
comment
on
the
waste
site's
plans.
After
the
inspection,
we
notify
DOE
of
our
compliance
determination
by
letter,
and
place
the
letter
and
the
report
of
the
inspection
in
our
docket
(§
194.8(
b)(
3)).
Finally,
we
perform
follow­
up
inspections
at
a
site
to
verify
the
continuing
compliance
of
approved
waste
characterization
programs
(§
194.8(
b)(
4)).
The
following
two
subsections
explain
the
purpose
of
the
requirements
described
above
and
the
basic
elements
of
a
waste
characterization
inspection.

1.
What
Is
the
Purpose
of
EPA's
Waste
Characterization
Inspections?
The
purpose
of
EPA
inspections
at
DOE
sites
is
to
verify
that
TRU
waste
sites
are
characterizing
and
tracking
the
waste
such
that
EPA
is
confident
that
the
volume
and
characteristics
of
the
wastes
conform
with
the
requirements
of
the
WIPP
LWA
and
the
specific
conditions
of
the
Certification
Decision.
The
requirements
set
forth
at
§
194.8(
b)
establish
a
process
by
which
EPA
determines
whether
DOE
is
in
compliance
with
Condition
3
of
the
Certification
Decision.
Condition
3
states,
``[
t]
he
Secretary
[of
Energy]
shall
not
allow
shipment
of
any
waste
from
any
additional
LANL
[Los
Alamos
National
Laboratory]
waste
stream(
s)
or
from
any
waste
generator
site
other
than
LANL
for
disposal
at
the
WIPP
until
the
Agency
has
approved
the
processes
for
characterizing
those
waste
streams
for
shipment
using
the
process
set
forth
in
§
194.8.''
(40
CFR
part
194,
Appendix
A.)
Accordingly,
§
194.8(
b)
sets
forth
procedural
requirements
for
EPA's
approval
of
DOE
TRU
waste
sites
to
ship
specific
waste
streams
or
groups
of
waste
streams
to
WIPP.
The
basis
for
applying
Condition
3
to
the
WIPP
project
is
rooted
in
our
rationale
for
the
waste
characterization
criteria
in
§
194.24.
We
developed
these
criteria
because,
``
in
order
to
make
meaningful
predictions
about
the
performance
of
the
WIPP
over
long
periods
of
time,
it
is
necessary
to
have
a
good
understanding
of
the
characteristics
of
the
waste
proposed
to
be
emplaced
in
the
disposal
system.
''
(Compliance
Criteria
proposed
rule,
60
FR
5771).
We
required
DOE
to
show,
in
its
compliance
application
for
the
WIPP,
that
a
``
system
of
controls''
was
in
place
to
ensure
that
``
the
actual
characteristics
of
waste
will
be
identified
before
the
waste
is
emplaced
in
the
WIPP.
''
(60
FR
5772).
The
DOE
developed
an
extensive
set
of
technical
and
quality
assurance
requirements
with
which
all
transuranic
waste
sites
must
comply
before
shipping
waste
to
the
WIPP
for
disposal.
At
the
time
of
application,
DOE
had
incorporated
these
requirements
into
such
documents
as
the
Quality
Assurance
Program
Plan
(QAPP),
Waste
Acceptance
Criteria
(WAC),
and
Quality
Assurance
Project
Plan
(QAPjP).
However,
DOE
did
not
submit
the
necessary
information
about
all
transuranic
waste
site
programs
in
the
application.
At
the
time
that
DOE
submitted
the
CCA,
most
sites
had
not
begun
the
complex
process
of
complying
with
the
WIPP
waste
characterization
requirements
and
the
information
therefore
was
not
available
to
EPA
during
the
certification
process.
(Certification
Decision
proposed
rule
62
FR
58813–
58814).
Consequently,
we
were
not
able
to
determine
during
the
certification
rulemaking
that
the
technical
and
quality
assurance
requirements
for
waste
characterization
activities
had
been
established
and
properly
executed
at
all
transuranic
waste
sites.
LANL
was
the
only
transuranic
waste
site
to
demonstrate
during
the
certification
rulemaking
that
it
could
meet
the
waste
characterization
requirements
for
certain
wastes.
Therefore,
as
stated
in
Condition
3
of
the
certification,
EPA
only
authorized
DOE
to
ship
legacy
debris
waste
from
LANL
to
the
WIPP.
DOE
was
not
authorized
to
ship
other
than
legacy
debris
waste
from
LANL,
or
any
waste
streams
from
other
TRU
waste
sites,
until
DOE
had
demonstrated
the
ability
to
properly
characterize
these
wastes.
DOE's
Carlsbad
Field
Office
(CBFO),
which
operates
the
WIPP,
is
responsible
for
maintaining
compliance
with
EPA's
waste
characterization
requirements.
DOE
transuranic
waste
sites
vary
considerably
with
regard
to
the
types
of
waste
they
characterize
and
the
manner
in
which
they
implement
the
program
requirements
of
CBFO.
Therefore,
confirmation
that
waste
characterization
is
adequate
must
take
place
where
waste
characterization
occurs,
that
is,
at
the
transuranic
waste
sites
themselves.
(Certification
Decision
final
rule,
63
FR
27392).
Inspections
of
waste
characterization
programs
at
individual
sites
are
the
best
way
for
us
to
verify
that
the
sites
have
identified
the
actual
characteristics
of
the
waste.
During
inspections,
we
have
access
to
the
site
personnel
who
perform
the
work,
to
the
facilities
and
equipment
used
at
the
site,
and
to
the
operators'
extensive
documentation.
Direct
observation
of
the
site's
activities
greatly
increases
our
confidence
in
their
effectiveness.
Confidence
in
the
results
of
waste
characterization
is
particularly
important
at
this
early
stage
of
disposal,
when
DOE
is
characterizing
waste
that
TRU
waste
sites
packaged
years
before
the
establishment
of
the
WIPP
Compliance
Criteria.
7
2.
What
Are
the
Elements
of
an
EPA
Waste
Characterization
Inspection?
After
EPA
determines
that
an
inspection
is
necessary,
we
define
the
scope
of
the
inspection
based
on
information
provided
by
DOE.
We
then
prepare,
and
share
with
DOE,
a
checklist
for
each
of
the
activities
that
we
will
inspect.
During
the
inspection,
our
evaluation
of
a
site's
waste
characterization
activities
typically
involves
the
activities
listed
below.
EPA
inspectors
may
or
may
not
perform
these
and
other
activities
depending
on
the
scope
of
the
inspection.
 
Review
procedures,
records
of
the
maintenance
and
calibration
of
equipment
and
instruments,
and
personnel
training
files.
 
Interview
responsible
personnel
(such
as
equipment
operators)
and
site
managers
overseeing
program
implementation.
 
Observe
analytical
testing
of
waste
drums
selected
by
EPA
inspectors
to
ensure
that
approved
procedures
are
followed
and
an
instrument
is
capable
of
analyzing
a
given
waste
stream.
 
Observe
equipment
operation
to
determine
whether
the
operator
has
deviated
from
the
procedures
and
why
and
how
the
deviation
may
haven
affected
the
waste
characterization.
 
Review
waste
stream
data
reports.
 
Track
waste
characterization
data
through
various
phases
of
its
generation
and
confirmation
and
eventual
inclusion
in
the
WWIS.

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/
Vol.
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No.
154
/
Friday,
August
9,
2002
/
Proposed
Rules
8
In
the
context
of
its
194.8
inspections,
EPA
has
defined
a
finding
as
``
a
determination
that
a
specific
item
or
activity
is
not
in
compliance
with
40
CFR
part
194.''
Similarly,
EPA
has
defined
a
concern
as
``
an
opinion
that
a
specific
item
or
activity
may
lead
to
noncompliance
with
40
CFR
part
194
at
a
future
time''.
The
inspectors'
determinations
are
recorded
in
the
checklist
for
each
activity
that
we
inspect.
At
the
end
of
each
inspection,
we
prepare
an
inspection
report.
The
completed
checklists
are
included
in
the
inspection
report.
The
inspection
report
also
describes
any
findings
or
concerns
that
the
inspectors
identified,
and
states
whether
EPA
requires
a
response
showing
how
any
unresolved
finding
or
concern
was
resolved.
8
It
is
sometimes
necessary
to
return
to
a
site
to
confirm
the
adequate
resolution
of
a
finding.
After
a
site
is
approved,
EPA
may
review
the
site's
progress
on
issues
that
we
identified
previously
during
a
subsequent
compliance
inspection.

B.
What
Are
the
Proposed
Changes
to
§
194.8(
b)?
Section
194.8
will
continue
to
describe
the
process
by
which
EPA
will
inspect
and
approve
waste
characterization
activities
at
TRU
waste
sites.
However,
we
are
proposing
to
alter
the
process
so
that
the
individual
waste
generator
sites
will
only
need
one
§
194.8
approval
from
EPA
to
conduct
waste
characterization
activities
related
to
all
on­
site
waste
streams.
This
single
§
194.8
approval
will,
however,
specify
any
limitations
on
the
approval
that
will
necessitate
additional
inspections
by
EPA.
Any
such
additional
inspections
will
be
conducted
under
authority
of
§
194.24(
h),
not
under
§
194.8.
The
second
key
change
is
that
the
opportunity
for
public
comment
will
come
after
EPA
has
completed
its
inspection,
but
before
EPA
has
approved
the
site.
Therefore,
EPA
will
request
public
comment
on
the
Agency's
inspection
report
and
proposed
compliance
decision
for
a
site
under
§
194.8.
The
revised
process
by
which
the
Agency
will
verify
compliance
with
Condition
3
of
the
certification
is
described
below,
followed
by
an
explanation
of
the
two
principal
procedural
changes
that
result
from
the
revisions.
Under
today's
proposal,
first,
we
require
DOE
to
implement
waste
characterization
programs
and
processes
in
accordance
with
§
194.24(
c)(
4)
to
confirm
that
the
total
amount
of
each
waste
component
that
will
be
emplaced
in
the
WIPP
will
not
exceed
the
upper
limiting
value
or
fall
below
the
lower
limiting
value
described
in
the
introductory
text
of
paragraph
(c)
of
§
194.24.
Waste
characterization
processes
include
the
collection
and
use
of
acceptable
knowledge;
destructive
and/
or
nondestructive
techniques
for
identifying
and
measuring
waste
components;
and
the
validation,
control,
and
transmittal
to
the
WIPP
Waste
Information
System
database
of
waste
characterization
data
in
accordance
with
§
194.24(
c)(
4).
Second,
DOE
must
notify
EPA
in
writing
that
a
waste
characterization
program
at
a
transuranic
waste
site
is
prepared
to
characterize
waste
destined
for
disposal
at
the
WIPP.
The
Department
will
also
send
documents
that
explain
the
site's
system
of
controls
for
waste
characterization,
including
the
use
of
acceptable
knowledge,
as
described
in
§
194.24(
c)(
4).
Third,
EPA
will
conduct
a
baseline
inspection
of
the
waste
characterization
program
at
the
site
to
verify
that
an
adequate
system
of
controls
has
been
established
in
plans
and
technical
procedures,
and
that
those
plans
and
procedures
are
adequately
implemented.
The
inspection
will
include
a
demonstration
by
DOE
of
the
following:
collection
and
appropriate
use
of
acceptable
knowledge
data;
destructive
and
nondestructive
techniques
for
measuring
waste
components
identified
in
accordance
with
§
194.24(
b)(
2),
performed
on
the
wastes
proposed
for
disposal;
verification
of
the
qualifications
of
the
personnel
responsible
for
performing
waste
characterization
activities;
and
the
validation,
control,
and
transmittal
to
the
WIPP
Waste
Information
System
database
of
waste
characterization
data,
in
accordance
with
§
194.24(
c)(
4).
It
may
be
necessary
to
conduct
follow­
up
inspection
activities
or
continuation
of
the
baseline
inspection
in
order
to
obtain
additional
information
and/
or
confirm
the
implementation
of
corrective
actions.
Fourth,
EPA
will
announce
in
the
Federal
Register
our
proposed
Baseline
Compliance
Decision
to
accept
the
site's
compliance
with
§
194.24(
c)(
4).
In
the
notice,
we
will
solicit
public
comment
on
the
relevant
inspection
report(
s)
and
all
supporting
materials
that
we
rely
upon
in
making
our
proposed
Baseline
Compliance
Decision.
These
materials
will
be
placed
in
the
public
docket
described
in
§
194.67.
The
notice
will
describe
any
limitations
on
approved
waste
streams
or
waste
characterization
processes
and
identify
(through
tier
designations)
what
changes
to
the
approved
waste
characterization
process
must
be
reported
to
and
approved
by
EPA
before
they
can
be
implemented.
EPA
will
designate
significant
changes
as
Tier
1;
minor
changes
will
be
designated
as
Tier
2.
The
notice
will
open
a
30­
day
public
comment
period
on
the
proposed
compliance
decision.
Fifth,
after
the
end
of
the
public
comment
period
our
written
final
Baseline
Compliance
Decision
will
be
conveyed
in
a
letter
from
the
Administrator's
authorized
representative
to
DOE.
DOE
will
comply
with
any
reporting
requirements
identified
in
the
Baseline
Compliance
Decision
and
the
accompanying
inspection
report.
A
section
summarizing
significant
comments
and
issues
arising
from
comments
received
on
the
compliance
decision,
as
well
as
the
Administrator's
response
to
those
comments
and
issues,
will
be
included
in
our
final
inspection
report
and
will
be
made
available
to
the
public
through
our
public
docket.
A
copy
of
our
compliance
decision
letter
will
also
be
placed
in
the
docket.
Last,
after
a
site
receives
our
Baseline
Compliance
Decision,
EPA
will
conduct
inspections
under
§
194.24(
h)
to
confirm
the
continued
compliance
of
the
programs
approved
and/
or
to
verify
the
adequacy
of
any
tier­
assigned
changes
to
the
waste
characterization
processes
not
authorized
by
our
Baseline
Compliance
Decision.
DOE
must
report
to
EPA
any
changes
as
identified
in
the
inspection
report
of
our
Baseline
Compliance
Decision.
The
reporting
will
inform
EPA's
decision
whether
to
perform
follow­
up
inspections.
The
results
of
EPA's
inspections
will
be
made
available
to
the
public
through
the
public
docket.
If
we
determine
that
the
system
of
controls
used
by
the
site
is
not
adequate
to
characterize
certain
waste
streams,
then
the
site
may
not
dispose
of
materials
from
those
waste
streams
at
the
WIPP
until
the
Agency's
findings
have
been
adequately
resolved.

1.
Changes
to
the
Scope
of
EPA
Approvals
of
Waste
Characterization
Programs
Under
the
proposed
new
provisions,
EPA
will
issue
a
proposed
Baseline
Compliance
Decision
that
describes
what
we
inspected
and
found
to
be
technically
adequate
and
also
identifies
DOE's
subsequent
reporting
requirements
for
the
waste
characterization
program
in
question.
The
various
elements
of
the
waste
characterization
program
will
be
tiered,
and
the
basis
for
the
tiering
will
be
described
in
the
inspection
report
that
accompanies
the
proposed
Baseline
Compliance
Decision.
The
proposed
tiering
approach
is
a
mechanism
by
which
EPA
can
specify
which
changes
to
an
approved
waste
characterization
program
require
EPA
approval
before
waste
characterized
by
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Federal
Register
/
Vol.
67,
No.
154
/
Friday,
August
9,
2002
/
Proposed
Rules
that
program
is
disposed
of
in
the
WIPP.
TRU
waste
sites
would
have
a
clear
understanding
of
which
changes
must
be
approved
by
EPA
prior
to
shipment
and
disposal.
The
tiering
of
elements
of
the
system
of
controls
for
waste
characterization
will
vary
depending
on
the
type
of
analytical
systems
that
a
site
has
demonstrated,
the
types
of
retrievably­
stored
waste
at
a
site,
and
the
type
and
quality
of
information
the
site
has
compiled
to
describe
waste
contents.
The
proposed
tiered
approach
applies
only
to
waste
characterization
activities
subject
to
§
194.8(
b)
requirements.
We
propose
to
institute
two
tiering
levels.
Tier
1
designation
will
be
given
to
activities
for
which
changes
have
a
potentially
significant
impact
on
compliance
with
EPA
regulations,
such
as
changes
that
directly
affect
measurements
and/
or
estimates
of
isotopes
and
other
limited
waste
components.
Tier
1
activities
are
those
for
which
EPA
approval
would
be
necessary
prior
to
shipment
and
disposal
of
waste.
For
example,
EPA
approval
would
be
necessary
if
a
site
introduced
a
new
radioassay
technique,
because
radioassay
is
a
critical
element
of
the
system
of
waste
characterization
controls.
Technical
areas
that
are
likely
to
be
subject
to
Tier
1
designation
are
acceptable
knowledge
and
radioassay.
DOE
will
be
required
to
submit
documentation
to
EPA
in
advance
that
describes
planned
changes
to
Tier
1
activities.
This
documentation
will
inform
EPA's
decision
regarding
which
actions,
such
as
performance
of
an
inspection,
are
necessary
in
order
to
approve
the
changes.
Tier
2
activities
are
those
for
which
EPA
approval
would
not
be
necessary
prior
to
shipment
and
disposal
of
waste.
An
approved
site
could
implement
changes
to
elements
of
the
waste
characterization
program
with
Tier
2
designation
without
first
being
inspected
or
approved
by
EPA.
However,
DOE
must
report
changes
in
the
manner
prescribed
by
EPA
in
the
Baseline
Compliance
Decision.
DOE's
reporting
of
changes
to
Tier
2
activities
will
assist
EPA
with
the
planning
of
follow­
up
inspections
at
sites.
Tier
2
designation
will
be
given
to
activities
that
have
a
minor
impact
on
compliance
with
the
WIPP
Compliance
Criteria
or
are
sufficiently
standardized
that
they
would
not
be
expected
to
change
significantly.
For
example,
the
actual
operation
of
radiographic
equipment
does
not
vary
greatly
from
machine
to
machine
or
from
site
to
site.
Also,
minor
revisions
to
procedures
are
a
regular
part
of
operations
and
usually
serve
to
clarify
or
improve
work
processes.
Technical
areas
that
are
likely
to
be
subject
to
Tier
2
designation
are
radiography
and
visual
examination.
The
required
reporting
by
DOE
of
Tier
2
changes
will
enable
EPA
to
monitor
the
overall
waste
characterization
program
at
a
site
and
develop
targeted
inspection
plans
for
continuing
compliance
inspections.
When
we
approve
a
waste
characterization
program,
we
will
assign
tiering
designations
based
chiefly
on
the
following
topics:
the
extent
to
which
a
process
was
demonstrated
at
the
time
of
our
§
194.8(
b)
inspection(
s);
quality
of
documentation;
the
range
of
possible
waste
streams
at
a
site;
the
demonstrated
proficiency
of
waste
characterization
personnel;
and
the
site's
compliance
with
DOE's
waste
acceptance
criteria
for
the
WIPP,
as
reviewed
and
approved
by
EPA.
Our
inspection
report
will
describe
EPA's
requirements
for
reporting
of
changes
to
waste
characterization
activities,
including
the
scope
and
frequency
of
reporting.
Sites
that
have
not
been
authorized
by
EPA
to
ship
waste
to
the
WIPP
under
the
current
provisions
of
§
194.8(
b)
will
be
subject
to
the
new
process
immediately
after
we
issue
the
final
version
of
this
rule.
For
sites
that
already
have
received
EPA's
approval
to
ship
certain
waste
streams,
we
are
proposing
to
reinspect
those
sites
using
the
revised
process.
In
other
words,
we
will
perform
a
full­
scope
inspection
at
approved
sites
(Hanford
Site,
Idaho
National
Energy
and
Environment
Laboratory,
Los
Alamos
National
Laboratory,
Rocky
Flats
Environmental
Technology
Site,
and
the
Savannah
River
Site)
in
order
to
reset
the
Baseline
Compliance
Decision
based
on
current
activities
at
the
sites.
We
will
place
our
proposed
compliance
decision
for
each
approved
site
in
our
docket
and
open
comment
on
it.
TRU
waste
sites
with
an
approved
waste
characterization
program
may
continue
to
ship
waste
within
the
scope
of
the
existing
approval
while
the
baseline
inspection
process
is
taking
place,
provided
that
they
continue
to
operate
in
accordance
with
the
WIPP
Compliance
Criteria.
DOE
has
initiated
an
effort
called
the
Central
Characterization
Project
(CCP)
to
assist
small
quantity
TRU
waste
sites
with
the
completion
of
the
waste
characterization
activities
required
by
EPA
and
State
agencies.
Under
the
CCP,
a
single
DOE
contractor
assumes
responsibility
for
the
characterization
of
a
site's
transuranic
waste.
The
CCP
sends
a
mobile
waste
characterization
laboratory
to
the
site
to
complete
certain
activities,
such
as
radioassay.
EPA
has
approved
the
CCP's
operation
at
the
Savannah
River
Site,
where
it
was
first
tested
[Air
Docket
A–
98–
49,
Item
II–
A4–
19].
Under
the
existing
provisions
for
§
194.8,
EPA
must
first
inspect
and
approve
the
CCP
at
each
site,
for
each
waste
stream
or
group
of
waste
streams.
Under
the
proposed
new
provisions,
EPA
approval
under
§
194.8(
b)
will
still
be
required
for
CCP
operations
at
each
site.
However,
once
we
have
approved
the
CCP
at
a
site,
the
CCP
will
be
approved
to
characterize
all
waste
streams
at
that
site.
Moreover,
any
subsequent
inspections
by
EPA
will
be
performed
under
§
194.24(
h).
The
same
processes
described
above
for
TRU
waste
sites
will
apply
to
our
compliance
decisions
for
the
CCP.

2.
Changes
to
Public
Notice
of
Waste
Characterization
Inspections
Under
the
existing
provisions
of
§
194.8(
b),
EPA
opens
comment
on
DOE
waste
characterization
plans
each
time
that
we
plan
to
inspect
a
waste
characterization
program
at
a
site,
if
that
program
involves
new
waste
streams
or
changes
to
the
system
of
waste
characterization
controls.
We
announce
comment
periods
and
dates
of
inspections
in
the
Federal
Register.
Because
each
site
has
multiple
waste
streams
and
evolving
waste
characterization
programs,
we
have
opened
multiple
comment
periods
on
different
documents
for
each
site
that
we
have
approved
to
ship
waste.
We
respond
to
the
relevant
comments
that
we
receive
in
our
inspection
reports,
and
docket
the
inspection
reports
and
compliance
decisions.
Under
the
new
provisions
of
§
194.8(
b),
EPA
will
request
comment
on
our
proposed
Baseline
Compliance
Decision
for
each
site,
which
includes
the
results
of
our
inspection(
s)
in
the
form
of
an
inspection
report,
and
any
appropriate
supporting
documentation,
such
as
objective
evidence
in
support
of
Agency
findings.
We
will
open
comment
periods
only
in
relation
to
baseline
inspections
under
§
194.8(
b).
We
will
continue
to
respond
to
the
relevant
comments
that
we
receive
in
our
inspection
reports,
and
to
docket
the
inspection
reports
and
compliance
decisions.
The
results
of
subsequent
inspections
of
waste
characterization
programs
that
we
perform,
including
for
the
purpose
of
approving
Tier
1
changes,
will
be
placed
in
our
docket.
In
addition
to
these
steps,
we
plan
to
continue
to
announce
our
inspections
and
other
WIPP­
related
activities
on
our
WIPP
home
page
at
www.
epa.
gov/
radiation/
wipp
and
our
WIPP
Information
Line
(1–
800–
331–
9477).
We
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Register
/
Vol.
67,
No.
154
/
Friday,
August
9,
2002
/
Proposed
Rules
9
The
existing
provisions
were
designed
to
address
the
fact
that
at
the
time
of
certification,
DOE
was
able
to
demonstrate
the
effectiveness
of
the
proposed
system
of
controls
for
waste
characterization
only
for
certain
waste
streams
at
Los
Alamos
National
Laboratory
[see
63
FR
27390].
10
EPA
has
prepared
a
document
entitled
``
Background
Information
Document
for
§
194.8(
b)
Modification''
(Air
Docket
OAR–
2002–
0005–
0001),
which
explains
in
more
detail
the
technical
elements
examined
during
waste
characterization
inspections,
summarizes
EPA's
inspection
experiences
to
date,
and
presents
lessons
learned.
This
document
expands
and
complements
this
preamble
discussion
for
the
proposed
revisions
to
§
194.8(
b).
encourage
the
public
to
visit
our
Website
and
to
contact
us
with
questions
or
information
regardless
of
whether
we
have
opened
a
public
comment
period.
(Comments
in
response
to
an
announcement
in
the
Federal
Register
should
be
sent
directly
to
the
EPA
docket
specified
in
the
announcement.)

C.
How
Has
EPA
Addressed
the
Alternative
Provision
Analysis
Required
by
§
194.6?
The
proposed
changes
to
§
194.8(
b)
are
needed
to
increase
the
options
available
to
EPA
in
implementing
our
regulatory
oversight
of
DOE's
waste
characterization
program,
and
to
simplify
the
public
notice
process.

1.
How
Do
the
Proposed
Changes
Comport
With
40
CFR
part
191?
Considered
individually
and
as
a
group,
the
proposed
changes
comport
fully
with
the
radioactive
waste
disposal
regulations
at
40
CFR
part
191.
The
inclusion
of
requirements
for
waste
characterization
in
order
to
implement
the
disposal
regulations
was
established
by
the
rulemaking
that
resulted
in
the
WIPP
Compliance
Criteria
at
40
CFR
part
194.
Today's
proposed
changes
do
not
alter
the
scope
of
the
part
191
requirements.
The
Compliance
Criteria
will
continue
to
apply
waste
characterization
requirements
to
the
WIPP
project.
The
principal
difference
between
the
existing
and
proposed
provisions
is
the
process
by
which
EPA
verifies
compliance
with
the
provisions
and
notifies
the
public
of
that
process.
This
new
process
will
not
substantively
affect
the
Compliance
Criteria's
implementation
of
EPA's
radioactive
waste
disposal
regulations
at
40
CFR
part
191.
Moreover,
EPA
believes
that
the
proposed
changes
to
the
194.8
approval
process
will
allow
for
more
meaningful
public
participation.

2.
Why
Do
the
Existing
Provisions
Appear
Inappropriate?
EPA
considers
the
existing
provisions
inappropriate
for
the
reasons
explicated
below.
EPA
explained
the
basis
for
the
existing
provisions
in
the
May
18,
1998,
Certification
Decision
final
rule
(63
FR
27354).
9
The
importance
of
independently
verifying
the
adequacy
of
waste
characterization
activities
conducted
by
DOE
has
not
grown
any
less
relevant.
However,
our
experience
with
site
inspections
since
the
1998
certification
decision
has
raised
two
key
issues
that
we
believe
must
be
addressed
through
alternative
provisions.
First,
for
a
variety
of
reasons,
the
focus
of
the
existing
provisions
on
waste
streams
as
the
determining
factor
for
initiation
of
an
inspection
is
overly
restrictive
for
EPA.
The
requirement
at
§
194.8(
b)(
1)
that
DOE
must
demonstrate
the
system
of
controls
for
each
waste
stream
or
group
of
waste
streams
reflects
the
fact
that
some
waste
streams
are
better
documented
than
others.
Consequently,
there
may
be
variations
in
how
a
given
site
uses
information
in
the
acceptable
knowledge
(AK)
record
in
relation
to
the
AK
confirmatory
program
that
DOE
employs
under
the
terms
of
the
Certification
Decision.
DOE
sites
must
report
to
WIPP
as
part
of
the
TRU
waste
tracking
requirement
on
a
container
basis,
quantities
of
10
WIPPtracked
radionuclides
(americium­
241,
cesium­
137,
plutonium­
238,
plutonium239
plutonium­
240,
plutonium­
242,
strontium­
90,
uranium­
233,
uranium234
and
uranium­
238)
disposed
of
at
the
WIPP.
Reporting
on
a
container
basis
may
require
sites
to
perform
additional
waste
analysis
if
using
the
site­
compiled
AK
is
not
adequate
to
estimate
these
radionuclides.
Similarly,
sites
are
responsible
for
reporting
the
quantities
of
cellulosics,
paper,
and
rubber
(CPR)
present
in
each
waste
container.
During
the
certification
rulemaking,
we
were
concerned
about
the
need
to
monitor
the
effect
of
these
variances
on
the
quality
of
waste
characterization
data.
Section
194.8(
b)
was
therefore
constructed
such
that
changes
to
the
system
of
controls,
in
addition
to
the
introduction
of
new
waste
streams,
would
be
sufficient
cause
to
require
separate
approval.
As
explained
in
the
194.8
BID
document,
EPA's
regulatory
experience
over
the
past
four
years
suggests
that
this
narrow
focus
on
specific
waste
streams
is
no
longer
necessary.
Second,
the
public
notice
process
described
in
§
194.8(
b)
has
not
yielded
the
level
of
comment
that
we
anticipated.
As
demonstrated
by
the
quantity
and
type
of
comments
we
have
received
following
publication
of
inspection
announcements
in
the
Federal
Register,
the
process
may
actually
be
a
source
of
confusion
for
the
public.
Each
of
these
issues
is
discussed
below.
a.
Why
are
the
existing
provisions
overly
restrictive
for
EPA?
EPA
now
has
several
years
of
experience
with
inspections
at
DOE
sites
where
waste
characterization
takes
place.
Since
certifying
the
WIPP
in
May
1998,
we
have
completed
over
twenty
inspections
under
authority
of
§
194.8.
We
also
have
completed
numerous
other
inspections
of
waste
characterization
activities
under
authority
of
§§
194.21
and
194.24(
h).
We
conducted
the
§
194.8
inspections
at
Los
Alamos
National
Laboratory,
Rocky
Flats
Environmental
Technology
Site,
Idaho
National
Engineering
and
Environmental
Laboratory,
the
Nevada
Test
Site,
the
Savannah
River
Site,
and
the
Hanford
Site.
In
addition,
we
inspected
the
operation
of
the
DOE
Central
Characterization
Program
(CCP)
at
the
Savannah
River
Site.
We
approved
all
of
the
programs
we
inspected
except
for
the
Nevada
Test
Site.
We
also
have
observed
DOE
audits
at
Lawrence
Livermore
Laboratory
and
Battelle
Columbus
Laboratory
for
the
purpose
of
learning
about
the
system
of
waste
characterization
controls
those
sites
are
developing.
10
Based
on
this
experience,
we
have
determined
that
the
existing
provisions
constrain
EPA's
ability
to
apply
limited
resources
to
a
burgeoning
waste
characterization
program
for
maximum
regulatory
benefit.
Under
the
existing
provisions,
we
must
conduct
a
§
194.8
inspection
at
a
site
if
any
of
the
following
conditions
is
true:
the
site
has
not
previously
been
approved
by
EPA
to
ship
waste;
the
site
seeks
approval
for
one
or
more
new
waste
streams
that
will
be
characterized
using
approved
processes;
the
site
seeks
approval
for
one
or
more
new
waste
streams
that
will
be
characterized
using
at
least
one
new
or
revised
process;
or
the
site
seeks
approval
to
introduce
a
new
or
revised
process
to
characterize
one
or
more
previously
approved
waste
streams.
DOE
is
currently
engaged
in
waste
characterization
at
five
major
sites,
and
plans
to
begin
operations
at
four
or
more
additional
sites
in
the
near
future.
The
number
of
DOE
sites
that
ultimately
will
ship
waste
to
the
WIPP
could
grow
to
approximately
two
dozen.
There
are
or
will
be
hundreds
of
waste
streams
at
these
sites,
and
the
methods
used
to
characterize
them
will
change
as
sites
acquire
new
instruments
and
techniques.
Consequently,
the
expansion
of
DOE's
national
transuranic
waste
shipment
program
could
lead
to
an
indefinite
expansion
of
EPA's
inspection
program.
If
EPA
must
complete
a
§
194.8
inspection
for
each
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Federal
Register
/
Vol.
67,
No.
154
/
Friday,
August
9,
2002
/
Proposed
Rules
11
For
quality
assurance
purposes,
we
verify
that
data
validation
occurs
in
accordance
with
site
procedures,
and
that
properly
qualified
and
independent
QA
personnel
review
the
data.
This
step
takes
place
during
a
QA
audit
or
inspection.
For
technical
purposes,
we
independently
verify
the
quality
of
a
sample
of
data.
This
step
takes
place
during
a
waste
characterization
inspection.
12
Currently,
EPA
is
able
to
conduct
such
a
broad
scope
inspection.
However,
new
processes
and/
or
waste
streams
must
be
inspected
under
§
194.8(
b),
and
previously
approved
processes
and/
or
waste
streams
must
be
inspected
under
§§
194.21
and
194.24(
h).
Today's
proposal
would
allow
EPA
to
review
new
processes
and
waste
streams
under
§
194.24(
h)
after
a
site
has
been
initially
approved
under
§
194.8(
b).
new
waste
stream,
group
of
waste
streams,
or
waste
characterization
process,
the
demands
of
this
inspection
regime
will
overwhelm
our
resources.
We
believe
that
it
is
appropriate
to
amend
the
Compliance
Criteria
to
increase
the
flexibility
of
our
waste
characterization
inspection
program.
At
present,
the
most
restrictive
factor
in
the
existing
provisions
is
that
§
194.8(
b)
requires
EPA
to
issue
approvals
that
are
specific
to
individual
waste
streams
or
groups
of
waste
streams.
Our
experience
with
DOE's
waste
characterization
activities
since
1998
has
shown
that
there
are
multiple
factors
that
must
be
considered
when
verifying
technical
adequacy,
including
but
not
limited
to
waste
groupings.
Moreover,
for
purposes
of
waste
characterization
as
required
under
the
Compliance
Criteria,
the
applicable
waste
groupings
at
the
site
are
often
of
limited
relevance.
Typically,
DOE
TRU
waste
sites
define
and
delineate
waste
streams
on
the
basis
of
factors
related
to
hazardous
components
of
the
waste,
not
radiological
waste
components.
Thus,
while
the
waste
stream
groupings
may
have
significant
relevance
for
RCRA
purposes,
they
are
often
of
less
relevance
for
purposes
of
waste
characterization
requirements
conducted
under
authority
of
the
WIPP
LWA.
In
order
to
approve
a
site's
waste
characterization
program,
we
must
be
confident
that
the
site
is
capable
of
identifying
and
reporting
waste
components
(particularly
certain
radioisotopes)
identified
in
the
1998
Certification
Decision
as
important
to
compliance
(see
Compliance
Application
Review
Document
(CARD)
31,
Air
Docket
A–
93–
02,
Item
V–
B–
2).
As
DOE
stated
in
Chapter
4
of
the
Compliance
Certification
Application
(Air
Docket
A–
93–
02,
Item
II–
G–
1),
a
combination
of
qualitative
and
quantitative
methods
would
be
used
to
identify
and
report
waste
components.
These
methods
are:
acceptable
knowledge,
which
provides
information
about
waste
stream
contents
and
the
processes
that
generated
the
waste;
nondestructive
examination
of
waste
containers
using
radiographic
techniques,
which
provides
qualitative
estimates
of
physical
waste
components;
destructive
and
nondestructive
examination
of
waste
containers
using
radioassay
techniques,
which
was
the
only
quantitative
means
proposed
by
DOE
to
quantify
radioisotopic
components;
destructive
(visual)
examination
of
sampled
containers
to
confirm
the
results
of
radiography
through
direct
observation
and
measurement;
and
data
reporting
via
the
WIPP
Waste
Information
System
(WWIS).
Confirmation
of
data
validity
at
various
points
is
an
integral
part
of
these
processes.
11
All
of
these
technical
processes
constitute
the
``
system
of
controls''
specified
in
§
194.24(
c)(
4).
The
demonstrated
effectiveness
of
a
given
element
of
the
system
of
controls
may
or
may
not
be
constrained
by
the
specific
features
of
a
waste
stream.
A
TRU
waste
site's
implementation
of
certain
elements
of
the
system
of
controls,
such
as
the
WWIS,
may
not
change
at
all
from
one
waste
stream
to
the
next.
In
contrast,
which
nondestructive
assay
techniques
may
be
effective
for
a
given
waste
stream
depends
in
part
on
the
physical
form
of
the
waste
and
the
quality
of
the
acceptable
knowledge
for
that
waste.
The
result
most
often
has
been
that
we
have
defined
limitations
on
approved
waste
streams
based
on
the
element
of
the
system
of
controls
whose
effectiveness
is
tied
most
closely
to
the
characteristics
of
individual
waste
streams,
that
is,
nondestructive
assay
(NDA).
We
have
limited
(or
narrowed)
our
approvals
to
certain
NDA
equipment
because
factors
such
as
the
calibration
and
physical
location
of
an
individual
instrument
are
important
to
the
technical
adequacy
of
the
method,
and
because
instrument
performance
varies
based
on
the
radioisotopes
in
a
waste
container.
DOE
may
only
ship
waste
streams
characterized
with
certain
equipment;
otherwise,
EPA
must
conduct
another
§
194.8
inspection
to
approve
new
equipment.
Our
new
approach
to
waste
characterization
inspections,
with
the
new
tiering
approach,
will
require
DOE
to
report
changes
such
as
the
introduction
of
new
nondestructive
assay
equipment,
but
will
allow
EPA
to
determine
whether
an
inspection
is
needed
for
the
new
equipment.
Under
Tier
2,
it
is
possible
that
a
``
desktop''
review
of
procedures
and
data
packages
will
be
sufficient
to
demonstrate
the
similarity
of
a
new
process
to
an
approved
process.
Alternatively,
under
Tier
1,
EPA
will
have
flexibility
to
schedule
an
inspection
whose
scope
covers
multiple
processes
and
waste
streams,
etc.
12
Ultimately,
the
critical
factor
in
our
decision
making
on
the
initial
approval
is
how
effectively
TRU
waste
sites
set
and
enforce
appropriate
limitations
on
the
usage
of
certain
techniques,
and
how
carefully
they
confirm
and
control
the
results
of
those
techniques.
Issuance
of
our
approval
under
§
194.8(
b)
means
that
we
have
found
that
the
site
developed
appropriate
procedures
for
waste
characterization
processes;
the
site
properly
implemented
those
procedures;
and
we
are
confident,
based
on
our
independent
evaluation,
that
the
data
reported
to
the
WWIS
are
properly
controlled.
We
will
continue
to
make
this
assessment
during
the
initial
§
194.8
inspection(
s)
at
a
site.
Under
the
existing
provisions,
introduction
of
any
waste
streams
or
processes
outside
the
scope
of
the
initial
approval
necessitates
potentially
many
more
§
194.8(
b)
inspections.
The
changes
that
we
are
proposing
today
will
not
alter
our
authority
to
limit
the
scope
of
any
site
approval.
Rather,
the
changes
will
enable
EPA
to
determine
independently
whether
a
subsequent
inspection
is
appropriate,
and
when
it
should
occur.
We
reserve
the
authority
to
specify
any
appropriate
limitations
on
the
waste
streams
that
may
be
shipped
and
the
processes
that
may
be
used
to
characterize
waste.
b.
How
can
the
public
notice
process
for
§
194.8
inspections
be
improved?
Under
the
existing
provisions,
EPA
must
publish
a
notice
in
the
Federal
Register
announcing
a
scheduled
inspection
under
authority
of
§
194.8(
b)(
2).
In
the
same
notice
or
a
separate
notice,
we
must
solicit
public
comment
for
at
least
thirty
days
on
waste
characterization
program
plans
and
other
documents
relevant
to
the
inspection.
DOE
sends
these
plans
and
other
documents
to
EPA
and
we
place
copies
in
our
public
docket
and
supplemental
dockets.
After
the
comment
period
has
ended,
we
notify
DOE
by
letter
of
our
compliance
determination
and
place
the
resulting
inspection
reports
in
our
dockets
(§
194.8(
b)(
3)).
In
our
1998
Certification
Decision,
we
explained
the
rationale
for
the
process
described
in
§
194.8(
b).
In
particular,
we
explained
that
our
compliance
decision
must
be
based
on
our
independent
inspections
of
waste
characterization
processes.
Inspections
involve
review
of
many
different
documents,
interviews
with
staff,
and
on­
site
demonstrations,
which
are
then
summarized
and
made
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/
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9,
2002
/
Proposed
Rules
public
in
our
inspection
reports
[see,
for
example,
EPA
Air
Docket
A–
93–
02,
Item
V–
C–
1,
pp.
2–
8
to
2–
11
and
6–
26].
We
are
not
able
to
provide
all
potentially
relevant
information
in
our
dockets
when
we
open
a
public
comment
period.
Under
the
existing
provisions,
we
open
comment
on
the
top­
tier
program
plans
that
describe
the
fundamental
requirements
for
and
organization
of
waste
characterization
activities
at
a
site,
plus
additional
procedures
if
appropriate
to
the
scope
of
the
inspection.
Such
documents
inform
our
preparation
for
an
inspection
and
are
sufficient
to
allow
the
public
to
raise
compliance
concerns
or
questions,
or
provide
additional
information
to
EPA,
so
that
we
are
aware
of
that
information
prior
to
reaching
a
compliance
decision.
We
refrain
from
reaching
a
final
compliance
decision
until
we
have
reviewed
and
responded
to
public
comment.
Our
inspection
reports
reference
the
specific
materials
that
we
reviewed
at
the
site
and
contain
objective
evidence
in
support
of
our
findings.
As
mentioned
above,
we
have
completed
a
significant
number
of
inspections
under
authority
of
§
194.8(
b)
since
May
1998.
We
have
published
a
total
of
twenty­
one
Federal
Register
notices
related
to
those
inspections.
In
response,
we
received
only
nine
sets
of
comments,
which
we
believe
to
be
low.
Also,
several
comments
consisted
of
requests
to
extend
a
public
comment
period,
which
suggests
there
may
be
a
misunderstanding
of
the
purpose
of
the
comment
period
under
current
procedures
(that
is,
to
comment
on
the
waste
characterization
documents
in
the
docket
and/
or
raise
concerns
to
EPA).
Specifically,
at
least
one
of
the
requests
argued
that
an
extension
was
appropriate
so
that
information
other
than
the
waste
characterization
plans
and
procedures
could
be
docketed
and
reviewed
by
the
public.
Both
of
these
factors
indicate
that
the
existing
provisions
for
public
notice
are
not
optimal
for
either
EPA
or
the
public.
There
is
also
evidence
to
suggest
that
the
conditions
that
necessitate
additional
§
194.8
inspections
at
an
approved
site
may
not
be
widely
understood,
even
within
the
DOE
transuranic
waste
complex.
The
most
serious
example
occurred
in
July
2001,
when
EPA
learned
that
waste
was
shipped
from
DOE's
Idaho
site
(INEEL)
and
disposed
of
in
the
WIPP
despite
having
been
assayed
by
equipment
that
had
not
approved
by
EPA
following
inspection.
INEEL
had
received
our
approval
to
use
certain
waste
characterization
processes
on
certain
waste
streams
in
1999,
but
the
equipment
in
question
was
not
included
in
the
previous
approval.
During
an
inspection
to
investigate
the
nonconformance,
we
learned
that
its
cause
was
an
isolated
failure
to
follow
document
control
procedures.
Nevertheless,
our
interviews
with
site
personnel
and
Carlsbad
Field
Office
personnel
revealed
confusion
over
whether
a
§
194.8(
b)
inspection
(including
public
notice)
was
required
for
the
new
equipment
(see
Air
Docket
A–
98–
49,
Item
II–
A1–
28).
In
response
to
these
issues,
the
new
public
notice
process
that
we
are
proposing
would
change
three
key
aspects.
First,
each
site
would
be
inspected
only
once
under
§
194.8(
b),
therefore
only
one
comment
period
would
be
opened
for
each
site
under
§
194.8.
Second,
EPA
would
solicit
comment
not
only
on
DOE
documentation,
but
also
on
our
baseline
inspection
report(
s)
and
proposed
compliance
decision
for
each
site.
The
comment
period
would
begin
after
we
have
completed
all
necessary
inspections
and
assembled
the
inspection
report(
s).
Third,
the
inspection
report
resulting
from
a
site's
§
194.8(
b)
baseline
inspection(
s)
would
identify
and
explain
EPA's
tier
assignments
for
DOE
reporting
of
changes
to
the
approved
waste
characterization
processes,
based
on
the
conditions
and
maturity
of
the
waste
characterization
program
particular
to
that
site.
This
reporting
would
inform
EPA
that
a
site
has
implemented
or
is
considering
changes
to
the
approved
waste
characterization
processes.
For
those
changes
requiring
EPA
approval,
we
would
perform
follow­
up
inspections
prior
to
allowing
changes
in
the
site's
system
of
controls,
or
in
the
waste
streams
shipped
from
the
site.
We
believe
that
this
approach
is
more
straightforward
than
the
existing
provisions
and
should
serve
to
reduce
any
confusion
about
the
public
notice
process
that
may
exist.

3.
What
Are
the
Costs,
Risks,
and
Benefits
of
Compliance
With
the
Alternative
Provisions?
Since
1998,
we
have
conducted
over
twenty
inspections
under
§
194.8(
b),
at
an
average
cost
of
approximately
$22,350
each
(this
estimate
includes
contractor
travel
and
technical
support
plus
labor
and
travel
costs
of
EPA
personnel).
These
inspections
were
conducted
to
approve
both
new
waste
streams
and
new
waste
characterization
processes
proposed
by
DOE.
DOE
has
identified
569
different
waste
streams
as
potentially
eligible
for
disposal
at
the
WIPP
facility
[Air
Docket
A–
93–
02,
Item
II­
G–
1,
Vol.
s
III­
IV,
Appendix
BIRTransuranic
Baseline
Inventory
Report].
If
we
were
to
continue
to
approve
site
waste
characterization
activity
on
a
waste
stream
basis,
the
costs
and
logistics
of
our
inspection
schedule
would
rapidly
become
unmanageable.
DOE
incurs
costs
as
a
result
of
being
inspected
by
EPA.
Operations
may
be
interrupted
to
some
extent
while
key
personnel
respond
to
the
inquiries
of
inspectors
and
operators
respond
to
EPA's
requirements
for
testing
of
equipment.
The
additional
reporting
requirements
introduced
by
the
proposed
new
provisions
also
represent
costs
to
DOE.
However,
we
do
not
anticipate
that
the
long­
term
costs
to
DOE
due
to
the
proposed
new
provisions
will
be
greater
than
at
present.
The
risk
associated
with
the
proposed
new
provisions
is
the
same
as
that
which
exists
for
the
existing
provisions.
There
is
always
a
possibility
that
a
compliance
issue
may
continue
undetected
by
EPA
for
a
period
of
time,
leading
to
the
improper
placement
of
waste
in
the
repository.
With
regard
to
this
possibility,
we
note
several
important
considerations.
First,
EPA
will
maintain
a
rigorous
inspection
program
for
WIPP
waste
characterization
activities.
Second,
DOE
is
required
to
maintain
an
active
quality
assurance
program
that
audits
waste
characterization
programs
on
an
annual
basis
for
compliance
with
applicable
regulatory
requirements.
Last,
as
the
operator
of
the
WIPP,
DOE
is
responsible
for
maintaining
the
quality
of
waste
characterization
programs.
As
a
regulator
of
the
WIPP,
EPA's
role
is
to
verify
independently
that
DOE
is
adequately
maintaining
quality.
The
combination
of
DOE's
internal
quality
assurance
audits
and
EPA's
independent
regulatory
inspections
has
proven
able
to
identify
compliance
issues
and
correct
them.
Therefore,
we
conclude
that
the
proposed
new
provisions
do
not
carry
greater
risks
for
compliance
with
the
disposal
regulations
than
the
existing
provisions.
The
benefits
of
the
new
provisions
were
described
in
the
preceding
section.
We
expect
site
shipment
activity
to
increase
as
approved
waste
generator
sites
incorporate
new
waste
streams
to
their
current
characterization
activities
and
new
waste
generator
sites
seek
EPA
approval
for
their
shipments
for
the
first
time.
Under
the
proposed
new
provisions,
EPA
will
have
more
control
over
our
inspection
schedule,
which
will
enable
us
to
manage
limited
resources
for
maximum
regulatory
benefit.
The
proposed
changes
will
not
alter
EPA's
technical
approach
to
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Federal
Register
/
Vol.
67,
No.
154
/
Friday,
August
9,
2002
/
Proposed
Rules
inspections
of
the
waste
characterization
capabilities
at
DOE
waste
generator
sites.
Inspections
will
continue
to
involve
in­
depth
interviews
of
personnel,
careful
reviews
of
analytical
procedures,
and
demonstrations
of
waste
characterization
techniques
and
equipment.
We
will
approve
only
sites
that
can
effectively
characterize
wastes
destined
for
disposal
at
the
WIPP.
Once
those
sites
are
approved,
we
will
continue
to
oversee
their
programs
through
ongoing
inspections.
Additionally,
we
expect
that
the
changes
to
the
public
notice
process
that
we
are
proposing
will
make
the
comment
period
for
inspections
more
relevant.
The
public
will
now
have
an
opportunity
to
review
and
comment
on
EPA's
proposed
decisions
and
inspection
reports
prior
to
site
approvals.
Finally,
the
new
provisions
will
be
beneficial
to
DOE
because
reporting
requirements
for
DOE
will
be
established
on
a
site­
by­
site
basis.
It
will
be
clearer
to
the
sites
when
a
particular
change
in
their
activities
will
trigger
review,
inspection,
or
approval
on
EPA's
part.
Also,
DOE
will
be
able
to
implement
changes
in
the
Tier
2
elements
of
their
waste
characterization
activities
without
prior
approval.
Sites
with
more
effective
waste
characterization
programs,
including
sites
that
successfully
demonstrate
the
applicability
of
waste
characterization
controls
to
the
broadest
possible
spectrum
of
waste
at
the
time
of
EPA's
inspection,
are
likely
to
have
more
activities
listed
in
Tier
2
than
sites
with
less
effective
programs.

V.
How
Is
EPA
Revising
the
Submission
of
Compliance
Applications
and
Reference
Materials
Requirements
in
§§
194.12
and
194.13?

A.
What
Are
the
Current
Requirements
in
§§
194.12
and
194.13?

Section
194.12
of
the
Compliance
Criteria
requires
DOE
to
submit
30
copies
of
the
compliance
applications
and
any
accompanying
materials
to
the
Administrator
in
printed
form.
This
provision
also
applies
to
the
compliance
applications
periodically
submitted
by
DOE
for
re­
certification
of
compliance.
Section
194.13
requires
that
10
printed
copies
of
referenced
materials
be
submitted
to
the
Administrator,
unless
such
materials
are
generally
available.

B.
What
Are
the
Proposed
Changes
to
§§
194.12
and
194.13?

EPA
proposes
to
revise
§
194.12
by
changing
the
number
of
copies
of
compliance
applications
in
printed
form
from
30
to
5
(one
original
and
four
printed
copies).
In
addition,
the
Agency
is
revising
§
194.12
to
require
that
DOE
submit
10
complete
compliance
applications
in
alternative
format
(e.
g.,
compact
disk)
or
other
approved
format.
Also,
the
Agency
is
proposing
to
revise
§
194.13
by
changing
the
number
of
copies
in
printed
form
of
the
reference
materials
from
10
to
5
and
to
require
DOE
to
submit
10
copies
of
reference
materials
in
alternative
format
(e.
g.,
compact
disk)
or
other
approved
format.

C.
How
Has
EPA
Addressed
the
Alternative
Provision
Analysis
Required
by
§
194.6?
The
proposed
changes
to
§§
194.12
and
194.13
are
intended
to
minimize
the
number
of
copies
in
printed
form
that
need
to
be
submitted
and
to
allow
for
the
submission
of
compliance
applications
and
reference
materials
in
alternative
format
(e.
g.,
compact
disk).
The
use
of
alternative
format
will
facilitate
compliance
with
40
CFR
part
194
requirements
because
it
will
expedite
EPA's
evaluation
of
the
compliance
application
and
reduce
costs
associated
with
the
review
of
compliance
applications
and
reference
materials.
Receipt
of
application
materials
in
alternative
format
will
also
improve
information
sharing
with
the
public
by
enabling
the
Agency
to
more
easily
make
these
materials
available
via
the
Internet.

1.
Why
Do
the
Existing
Provisions
in
§§
194.12
and
194.13
Appear
Inappropriate?
The
existing
provisions
in
§§
194.12
and
194.13
are
inappropriate
because
EPA
does
not
need
DOE
to
deliver
30
printed
copies
of
the
complete
compliance
application,
nor
10
printed
copies
of
all
reference
materials.
In
1996,
when
the
Compliance
Criteria
were
finalized,
the
Agency
required
that
30
copies
of
the
compliance
application
and
10
copies
of
the
referenced
material
be
submitted
for
use
in
our
review
and
evaluation
activities.
Printed
form
copies
were
necessary
because
the
Agency
had
a
limited
time
period
for
review
and
the
complexity
of
the
application
material
required
many
reviewers.
Also,
EPA
placed
copies
of
these
documents
in
various
public
dockets.
EPA's
requirements
for
the
submission
of
compliance
applications
and
reference
materials
have
changed
since
the
promulgation
of
the
Compliance
Criteria
in
1996.
If
material
is
submitted
in
alternative
format
(e.
g.,
compact
disk)
or
other
approved
format
instead
of
printed
matter,
it
is
only
necessary
to
have
5
printed
copies
of
the
compliance
application
and
5
printed
copies
of
the
reference
materials
not
included
in
previous
compliance
applications
(provided
that
the
information
has
remained
true
and
accurate)
for
our
four
public
dockets
(including
an
official
copy
for
EPA).
New
advances
in
information
management
require
the
use
of
new
submission
methods,
such
as
the
use
of
alternative
format
(e.
g.,
compact
disk).
Information
and
data
in
alternative
format
are
easier
to
view,
share,
navigate,
and
analyze.
However,
current
regulatory
language
in
§§
194.12
and
194.13
does
not
allow
for
the
submission
of
compliance
applications
and
reference
materials
in
alternative
format.
Therefore,
today's
action
proposes
to
revise
the
regulatory
language
in
these
sections
to
require
alternative
format
(or
other
approved
format)
submission
of
both
compliance
application
(also
re­
certification
applications)
and
reference
materials.

2.
How
Do
the
Proposed
Changes
in
§§
194.12
and
194.13
Comport
With
40
CFR
Part
191?
The
proposed
changes
to
§§
194.12
and
193.13
comport
fully
with
the
radioactive
waste
disposal
regulations
at
40
CFR
part
191.
The
inclusion
of
submission
requirements
for
compliance
applications
and
reference
materials
in
order
to
implement
the
disposal
regulations
was
established
by
the
rulemaking
that
resulted
in
the
WIPP
Compliance
Criteria
at
40
CFR
part
194.
Today's
proposed
changes
do
not
alter
the
scope
of
those
requirements.
The
Compliance
Criteria
would
continue
to
apply
submission
requirements
to
the
WIPP
project.
The
principle
differences
between
the
existing
and
proposed
new
provisions
are
that
the
number
of
printed
copies
to
be
submitted
to
EPA
has
been
reduced
considerably
and
alternative
format
(or
other
approved
format)
submission
of
compliance
applications
and
reference
materials
is
now
required.
The
proposed
revisions
to
this
part
do
not
impact
the
Compliance
Criteria's
implementation
of
40
CFR
part
191.

3.
What
Are
the
Costs,
Risks,
and
Benefits
of
Compliance
With
the
New
Provisions
in
§§
194.12
and
194.13?
Sections
194.12
and
194.13
require
DOE
to
submit
a
specified
number
of
copies
in
printed
form
of
the
compliance
application
and
reference
materials.
This
provision
also
applies
to
the
compliance
applications
periodically
submitted
by
DOE
for
recertification
of
compliance.
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Rules
13
This
definition
is
consistent
with
EPA's
and
DOE's
use
of
the
term
``
acceptable
knowledge''
during
the
WIPP
certification
rulemaking.
See,
for
example:
Air
Docket
A–
93–
02,
Item
II–
G–
1,
page
4–
45;
Item
V–
B–
2,
Compliance
Application
Review
Document
(CARD)
24,
page
24–
1;
and
63
FR
27390,
footnote
32.
14
Examples
of
processes
or
operations
that
create
transuranic
waste
are
molding
of
plutonium
with
crucibles,
laboratory
analysis
of
radioactive
samples,
and
chemical
separation
of
plutonium
from
other
materials.
The
number
and
types
of
processes
in
use
at
a
DOE
site
depends
on
the
nature
and
complexity
of
the
site's
mission.
proposed
revisions
reduce
the
number
of
copies
required
and
requires
submission
of
compliance
applications
and
references
in
alternative
format
(or
other
approved
format).
We
do
not
anticipate
any
cost
increase
related
to
our
implementation
of
the
changes
to
§§
194.12
and
194.13.
These
changes
will
improve
our
ability
to
view,
share,
navigate,
print,
and
analyze
submitted
materials.
We
expect
to
be
able
to
conduct
our
review
of
compliance
applications
in
a
more
efficient
and
cost
effective
manner.
Also,
the
implementation
of
these
changes
will
facilitate
our
ability
to
share
information
with
the
public
in
a
more
timely
fashion.
As
we
received
information
and
data
in
alternative
format,
it
would
be
easier
to
post
this
information
in
our
webpage.
Similarly,
we
do
not
anticipate
that
DOE
will
experience
any
cost
increase
as
a
result
of
their
compliance
activities
with
this
part
because
the
technology
to
produce
alternative
format
submittals
exists
and
is
currently
in
use.
We
do
not
anticipate
any
significant
risks
related
to
the
implementation
of
the
proposed
revisions
to
this
part.
Submission
of
information
and
data
in
other
than
paper
form
is
a
widely
accepted
process
that
will
ease
the
transfer
of
information
between
DOE
and
EPA
and
therefore,
improve
compliance
with
40
CFR
part
194.
In
summary,
the
benefits
of
the
proposed
revisions
for
§§
194.12
and
194.13
are
several.
First
the
Agency
will
benefit
from
an
improved
evaluation
process
and
reduced
costs
associated
with
the
review
of
compliance
applications
and
reference
materials.
Second,
the
public
will
be
able
to
have
better
and
faster
access
to
information
used
in
support
of
WIPP
compliance
activities.
This
change
will
improve
the
public's
ability
to
participate
more
actively
in
the
public
comment
process.
Third,
the
proposed
changes
to
§§
194.12
and
194.13
are
intended
to
reduce
the
number
of
copies
in
printed
form
that
must
be
submitted,
thereby
reducing
paper
usage.

VI.
How
Is
EPA
Revising
the
Waste
Characterization
Requirements
in
§
194.24(
c)(
3)?

A.
What
Are
the
Current
Waste
Characterization
Requirements
in
§
194.24(
c)(
3)?

Section
194.24,
waste
characterization,
generally
requires
DOE
to
identify,
quantify,
and
track
the
chemical,
physical,
and
radiological
components
of
the
waste
destined
for
disposal
at
WIPP
that
may
influence
disposal
system
performance.
Section
194.24(
c)(
3)
requires
DOE
to
demonstrate
that
the
use
of
process
knowledge
to
quantify
waste
components
conforms
with
the
quality
assurance
(QA)
requirements
outlined
in
§
194.22.
To
demonstrate
compliance
DOE
must
have
information
and
documentation
to
substantiate
that
process
knowledge
data
acquired
and
used
during
waste
characterization
activities
are
in
compliance
with
the
QA
requirements.
EPA
verifies
compliance
with
this
requirement
through
inspections,
where
EPA
conducts
proper
review
of
such
information
to
determine
whether
use
of
process
knowledge
data
is
appropriate
and
reliable.

B.
What
Are
the
Proposed
Changes
to
§
194.24(
c)(
3)?
The
Agency
is
proposing
to
revise
§
194.24(
c)(
3)
by
replacing
the
term
``
process
knowledge''
with
the
term
``
acceptable
knowledge.
''
The
term
``
acceptable
knowledge''
has
been
the
term
used
by
EPA
and
DOE
since
DOE
submitted
the
Compliance
Certification
Application,
during
both
the
certification
rulemaking
and
subsequent
site
inspections.
Use
of
the
term
``
acceptable
knowledge''
in
§
194.24(
c)(
3)
in
lieu
of
``
process
knowledge''
will
not
alter
our
technical
approach
to
verifying
compliance
during
an
inspection;
rather,
it
will
reflect
our
actual
practice
more
accurately.
For
consistency
with
the
change
being
proposed
today
for
§
194.24(
c)(
3),
the
Agency
is
also
proposing
to
add
the
following
definition
of
``
acceptable
knowledge''
to
§
194.2:
``
Acceptable
knowledge
means
any
information
about
the
process
used
to
generate
waste,
material
inputs
to
the
process,
and
the
time
period
during
which
the
waste
was
generated,
as
well
as
data
resulting
from
the
analysis
of
waste
conducted
prior
to
or
separate
from
the
waste
certification
process
authorized
by
EPA's
Certification
Decision,
to
show
compliance
with
Condition
3
of
the
certification
decision
(40
CFR
part
194,
Appendix
A).
''
13
Section
194.2
is
contained
in
Subpart
A
(General
Provisions)
of
the
rule,
which
describes
the
purpose
and
scope
of
the
regulation,
clarifies
terms,
specifies
dates,
and
imparts
a
range
of
administrative
information.
Section
194.2
focuses
on
providing
an
explanation
of
all
terms
and
abbreviations
contained
in
40
CFR
part
194
for
clarification
purposes.

C.
How
Has
EPA
Addressed
the
Alternative
Provision
Analysis
Required
by
§
194.6?
The
proposed
changes
for
both
§§
194.2
and
194.24(
c)(
3)
are
intended
to
clarify
exactly
what
information
EPA
requires
from
DOE.
EPA
expects
that
with
these
changes,
acceptable
knowledge
(AK)
will
be
more
clearly
identified
as
an
integral
part
of
the
system
of
controls
for
waste
characterization
and
will
require
DOE
to
provide
information
about
the
entire
system
of
controls
(including
AK)
and
implement
the
systems
at
each
site.
Again,
these
proposed
changes
in
terminology
do
not
alter
our
technical
approach
to
verifying
compliance
during
an
inspection,
but
will
reflect
our
actual
practice
more
accurately.

1.
Why
Do
the
Existing
Provisions
in
§
194.24(
c)(
3)
Appear
Inappropriate?
We
do
not
consider
the
existing
provisions
in
§
194.24(
c)(
3)
to
be
fully
inappropriate
because
process
knowledge
remains
a
crucial
component
of
the
waste
characterization
system
of
controls.
However,
the
Agency
seeks
to
improve
communication
with
DOE
and
the
public
and
the
use
of
consistent
and
clear
language
is
an
important
factor
towards
meeting
that
goal.
Section
194.24(
c)(
3)
is
used
to
verify
compliance
in
the
collection
and
appropriate
use
of
process
knowledge
during
waste
characterization,
and
that
the
procedures
adhere
to
the
quality
assurance
requirements
identified
in
§
194.22.
During
the
EPA
inspection
of
a
TRU
waste
site,
we
review
the
establishment
and
implementation
of
procedures
for
collection
and
use
of
process
knowledge,
demonstration
of
waste
characterization
processes,
and
the
qualifications
and
practices
of
technical
personnel.
The
term
``
process
knowledge,
''
as
currently
used
by
EPA
in
the
Compliance
Criteria,
incorporates
information
about
the
process
or
operation
that
led
to
the
creation
of
the
transuranic
waste.
14
The
term
``
acceptable
knowledge''
includes
process
knowledge,
any
data
resulting
from
analysis
of
waste
prior
to
WIPP
waste
characterization,
and
any
other
information
about
the
physical
form
of
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Rules
the
waste
and
its
base
components.
The
two
terms
are
related;
process
knowledge
is
a
subset
of
acceptable
knowledge.
In
Chapter
4
of
the
Compliance
Certification
Application,
DOE
used
the
term
``
acceptable
knowledge''
and
explained
that
this
term
incorporates
``
information
regarding
the
physical
form
of
the
waste,
the
base
materials
composing
the
waste,
and
the
process
that
generates
the
waste.
''
DOE
derived
this
usage
from
an
EPA
document
entitled,
``
Waste
Analysis
at
Facilities
that
Generate,
Treat,
Store,
and
Dispose
of
Hazardous
Waste:
A
Guidance
Manual
(EPA530–
R–
94–
024,
April
1994.''
This
guidance
defines
AK
broadly
as
including
process
knowledge,
waste
analysis
data
from
waste
generators,
and
records
of
analysis
performed.
A
hazardous
waste
treatment,
storage,
and
disposal
facility
when
accepting
hazardous
waste
for
management
may
test
waste
to
confirm
that
the
hazardous
waste
determination
done
by
a
generator
is
accurate
and
the
facility
indeed
can
handle
that
particular
waste
type.
The
referenced
guidance
document
applies
specifically
to
compliance
with
the
Resource
Conservation
and
Recovery
Act;
however,
its
definition
of
AK
is
consistent
with
the
definition
that
we
are
proposing
for
use
in
the
WIPP
Compliance
Criteria.
It
is
important
that
both
EPA
and
DOE
have
the
same
understanding
on
the
terminology
applicable
to
the
requirements
in
§
194.24(
c)(
3).
The
use
of
the
term
``
process
knowledge''
in
the
Compliance
Criteria
to
date
has
not
interfered
with
DOE's
compliance
with
the
terms
and
conditions
of
the
certification.
However,
EPA
seeks
to
avoid
the
possibility
for
miscommunication
now
or
in
the
future.

2.
How
Do
the
Proposed
Changes
in
§
194.24(
c)(
3)
Comport
With
40
CFR
part
191?
The
proposed
changes
to
§
194.24(
c)(
3)
comport
fully
with
the
radioactive
waste
disposal
regulations
at
40
CFR
part
191.
The
inclusion
of
requirements
for
waste
characterization
requirements
in
order
to
implement
the
disposal
regulations
was
established
by
the
rulemaking
that
resulted
in
the
WIPP
Compliance
Criteria
at
40
CFR
part
194.
Today's
proposed
changes
do
not
alter
the
scope
of
those
requirements.
The
Compliance
Criteria
would
continue
to
apply
waste
characterization
requirements
to
the
WIPP
project.
The
principle
difference
between
the
existing
and
proposed
new
provisions
is
the
replacement
of
the
term
process
knowledge
with
acceptable
knowledge.
The
use
of
the
new
term
would
not
substantively
affect
the
Compliance
Criteria's
implementation
of
40
CFR
part
191.

3.
What
Are
the
Costs,
Risks,
and
Benefits
of
Compliance
with
the
New
Provisions
in
§
194.24(
c)(
3)?

We
do
not
anticipate
any
cost
increase
related
to
our
implementation
of
the
changes
to
§
194.24(
c)(
3).
EPA
will
continue
to
conduct
waste
characterization
oversight
in
the
same
manner
as
before.
Similarly,
we
do
not
anticipate
that
DOE
will
experience
any
cost
increase
as
a
result
of
their
compliance
activities
with
this
part.
Essentially,
DOE
will
continue
to
comply
with
the
requirement
of
this
part
as
they
previously
have.
We
do
not
anticipate
any
risks
related
to
the
implementation
of
the
proposed
revisions
to
this
part.
The
Agency
anticipates
that
the
use
of
the
term
acceptable
knowledge
will
serve
to
enhance
communication
with
the
regulated
party
and
therefore,
compliance
with
40
CFR
part
194.
The
benefits
of
the
proposed
revisions
for
§
194.24(
c)(
3)
are
two­
fold.
First,
the
proposed
changes
will
not
affect
the
actual
technical
approach
to
verifying
compliance
during
our
independent
audits
and
inspections
of
the
relevant
WIPP
activities.
Therefore,
EPA
will
continue
to
enforce
the
waste
characterization
requirements
in
the
Compliance
Criteria
and
ensure
that
DOE's
waste
characterization
programs
are
properly
implemented.
Second,
the
clarification
of
the
applicable
terminology
will
ensure
that
no
confusion
arises
regarding
the
specific
waste
characterization
information
required
for
compliance.

VII.
Administrative
Requirements
A.
Executive
Order
12866
Under
Executive
Order
12866,
(58
FR
51735;
October
4,
1993),
the
Agency
must
determine
whether
the
regulatory
action
is
``
significant''
and
therefore
subject
to
OMB
review
and
the
requirements
of
the
Executive
Order.
The
Order
defines
``
significant
regulatory
action''
as
one
that
is
likely
to
result
in
a
rule
that
may:
(1)
Have
an
annual
effect
on
the
economy
of
$100
million
or
more
or
adversely
affect
in
a
material
way
the
economy,
a
sector
of
the
economy,
productivity,
competition,
jobs,
the
environment,
public
health
or
safety,
or
State,
local,
or
tribal
governments
or
communities;
(2)
create
a
serious
inconsistency
or
otherwise
interfere
with
an
action
taken
or
planned
by
another
agency;
(3)
materially
alter
the
budgetary
impact
of
entitlements,
grants,
user
fees,
or
loan
programs
or
the
rights
and
obligations
of
recipients
thereof;
or
(4)
raise
novel
legal
or
policy
issues
arising
out
of
legal
mandates,
the
President's
priorities,
or
the
principles
set
forth
in
the
Executive
Order.
Pursuant
to
the
terms
of
Executive
Order
12866,
it
has
been
determined
that
this
rule
is
not
a
``
significant
regulatory
action.
''

B.
Regulatory
Flexibility
Act
The
Regulatory
Flexibility
Act
(``
RFA'')
generally
requires
an
agency
to
conduct
a
regulatory
flexibility
analysis
of
any
rule
subject
to
notice
and
comment
rulemaking
requirements
unless
the
agency
certifies
that
the
rule
will
not
have
a
significant
economic
impact
on
a
substantial
number
of
small
entities.
Small
entities
include
small
businesses,
small
not­
for­
profit
enterprises,
and
small
governmental
jurisdictions.
This
proposed
rule
will
not
have
a
significant
impact
on
a
substantial
number
of
small
entities
because
it
sets
forth
requirements
which
apply
only
to
Federal
agencies.
Therefore,
I
certify
that
this
action
will
not
have
a
significant
economic
impact
on
a
substantial
number
of
small
entities.

C.
Paperwork
Reduction
Act
This
proposed
action
does
not
impose
an
information
collection
burden
under
the
provisions
of
the
Paper
Reduction
Act,
44
U.
S.
C.
3501
et
seq.
The
Compliance
Criteria
in
40
CFR
part
194
requirements
are
applicable
only
to
both
DOE
and
EPA
and
do
not
establish
any
form
of
collection
of
information
from
the
public.

D.
Unfunded
Mandates
Reform
Act
Title
II
of
the
Unfunded
Mandates
Reform
Act
of
1995
(``
UMRA''),
Public
Law
104–
4,
establishes
requirements
for
Federal
agencies
to
assess
the
effects
of
their
regulatory
actions
on
State,
local,
and
tribal
governments
and
the
private
sector.
Pursuant
to
Title
II
of
the
UMRA,
we
have
determined
that
this
regulatory
action
is
not
subject
to
the
requirements
of
sections
202
and
205,
because
this
action
does
not
contain
any
``
federal
mandates''
for
State,
local,
or
tribal
governments
or
for
the
private
sector.
This
rule
applies
only
to
Federal
agencies.

E.
Executive
Order
12898
Pursuant
to
Executive
Order
12898
(59
FR
7629,
February
16,
1994),
entitled
``
Federal
Actions
to
Address
Environmental
Justice
in
Minority
Populations
and
Low­
Income
Populations,
''
the
Agency
has
considered
environmental
justice
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Federal
Register
/
Vol.
67,
No.
154
/
Friday,
August
9,
2002
/
Proposed
Rules
related
issues
with
regard
to
the
potential
impacts
of
this
action
on
the
environmental
and
health
conditions
in
low­
income,
minority,
and
native
American
communities.
We
have
complied
with
this
mandate.
However,
the
requirements
specifically
set
forth
by
the
Congress
in
the
Waste
Isolation
Pilot
Plant
Land
Withdrawal
Act
(Pub.
L.
102–
579),
which
prescribes
EPA's
role
at
the
WIPP,
did
not
provide
authority
for
EPA
to
examine
impacts
in
the
communities
in
which
wastes
are
produced,
stored,
and
transported,
and
Congress
did
not
delegate
to
EPA
the
authority
to
consider
the
issue
of
alternative
locations
for
the
WIPP.
During
the
development
of
the
existing
provisions
in
40
CFR
part
194,
the
EPA
involved
minority
and
lowincome
populations
early
in
the
rulemaking
process.
In
1993,
EPA
representatives
met
with
New
Mexico
residents
and
government
officials
to
identify
the
key
issues
that
concern
them,
the
types
of
information
they
wanted
from
EPA,
and
the
best
ways
to
communicate
with
different
sectors
of
the
New
Mexico
public.
The
feedback
provided
by
this
group
of
citizens
formed
the
basis
for
EPA's
WIPP
communications
and
consultation
plan.
To
help
citizens
(including
a
significant
Hispanic
population
in
Carlsbad
and
the
nearby
Mescalero
Indian
Reservation)
stay
abreast
of
EPA's
WIPP­
related
activities,
the
Agency
developed
many
informational
products
and
services.
The
EPA
translated
into
Spanish
several
documents
regarding
WIPP,
including
educational
materials
and
fact
sheets
describing
EPA's
WIPP
oversight
role
and
the
radioactive
waste
disposal
standards.
The
EPA
also
established
a
toll­
free
WIPP
Information
Line,
recorded
in
both
English
and
Spanish,
providing
the
latest
information
on
upcoming
public
meetings,
publications,
and
other
WIPP­
related
activities.
The
EPA
also
developed
a
mailing
list,
which
includes
many
lowincome
minority,
and
native
American
groups,
to
systematically
provide
interested
parties
with
copies
of
EPA's
public
information
documents
and
other
materials.
Even
after
the
final
rule,
in
1998,
EPA
has
continued
to
implement
outreach
services
to
all
WIPP
communities
based
on
the
needs
determined
during
the
certification.
This
proposed
action
does
not
add
or
delete
any
certification
criteria.
The
proposal
would
revise
the
public
notice
process
for
the
approval
of
waste
characterization
activities
at
DOE
waste
generator
sites,
which
produce
and
store
wastes
destined
for
disposal
at
WIPP.
Affected
communities
and
the
public
in
general
would
have
the
opportunity
to
comment
on
EPA's
proposed
waste
generator
site
approval
decision.
The
existing
provision
does
not
offer
such
opportunity.
The
proposed
revision
makes
the
public
comment
period
more
meaningful
to
all
communities.
The
Agency
also
intends
to
continue
its
outreach
activities
to
make
information
on
waste
characterization
activities
more
accessible
by
using
the
Internet,
EPA
information
line,
and
fact
sheets.

F.
National
Technology
Transfer
&
Advancement
Act
of
1995
Section
12
of
the
National
Technology
Transfer
&
Advancement
Act
of
1995
is
intended
to
avoid
``
re­
inventing
the
wheel.
''
It
aims
to
reduce
costs
to
the
private
and
public
sectors
by
requiring
federal
agencies
to
draw
upon
any
existing,
suitable
technical
standards
used
in
commerce
or
industry.
To
comply
with
the
Act,
EPA
must
consider
and
use
``
voluntary
consensus
standards,
''
if
available
and
applicable,
when
implementing
policies
and
programs,
unless
doing
so
would
be
``
inconsistent
with
applicable
law
or
otherwise
impractical.
''
We
have
determined
that
this
regulatory
action
is
not
subject
to
the
requirements
of
National
Technology
Transfer
&
Advancement
Act
of
1995
as
this
rulemaking
is
not
setting
any
technical
standards.

G.
Executive
Order
13045:
Children's
Health
Protection
This
rule
is
not
subject
to
Executive
Order
13045,
entitled
``
Protection
of
Children
from
Environmental
Health
Risks
and
Safety
Risks''
(62
FR
19885,
April
23,
1997),
because
it
does
not
involve
decisions
on
environmental
health
risks
or
safety
risks
that
may
disproportionately
affect
children.

H.
Executive
Order
13132:
Federalism
Executive
Order
13132,
entitled
``
Federalism''
(64
FR
43255,
August
10,
1999),
requires
EPA
to
develop
an
accountable
process
to
ensure
``
meaningful
and
timely
input
by
State
and
local
officials
in
the
development
of
regulatory
policies
that
have
federalism
implications.
''
``
Policies
that
have
federalism
implications''
is
defined
in
the
Executive
Order
to
include
regulations
that
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.
''
This
proposed
rule
does
not
have
federalism
implications.
It
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.
This
proposed
action
revises
specific
portions
of
the
Compliance
Criteria
in
40
CFR
part
194.
These
criteria
are
applicable
only
to
both
DOE
(operator)
and
EPA
(regulator)
of
the
WIPP
disposal
facility.
Thus,
Executive
Order
13132
does
not
apply
to
this
rule.
In
the
spirit
of
Executive
Order
13132,
and
consistent
with
EPA
policy
to
promote
communications
between
EPA
and
State
and
local
governments,
EPA
specifically
solicits
comment
on
this
proposed
rule
from
State
and
local
officials.

I.
Executive
Order
13175:
Consultation
and
Coordination
with
Indian
Tribal
Governments
Executive
Order
13175,
entitled
``
Consultation
and
Coordination
with
Indian
Tribal
Governments''
(65
FR
67249,
November
9,
2000),
requires
EPA
to
develop
an
accountable
process
to
ensure
``
meaningful
and
timely
input
by
tribal
officials
in
the
development
of
regulatory
policies
that
have
tribal
implications.
''
This
proposed
rule
does
not
have
tribal
implications,
as
specified
in
Executive
Order
13175.
This
proposed
action
revises
specific
portions
of
the
Compliance
Criteria
in
40
CFR
part
194.
The
Compliance
Criteria
are
applicable
only
to
Federal
agencies.
Thus,
Executive
Order
13175
does
not
apply
to
this
rule.
In
the
spirit
of
Executive
Order
13175,
and
consistent
with
EPA
policy
to
promote
consultation
and
coordination
with
Indian
Tribal
Governments,
EPA
specifically
solicits
comment
on
this
proposed
rule
from
Tribal
officials.

J.
Executive
Order
13211:
Energy
Effects
This
proposed
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.

List
of
Subjects
in
40
CFR
Part
194
Environmental
protection,
Administrative
practice
and
procedure,
Nuclear
materials,
Radionuclides,
Plutonium,
Radiation
Protection,
Uranium,
Transuranics,
Waste
Treatment
and
Disposal.

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Federal
Register
/
Vol.
67,
No.
154
/
Friday,
August
9,
2002
/
Proposed
Rules
Dated:
July
30,
2002.
Christine
Todd
Whitman,
Administrator.

For
the
reasons
set
out
in
the
preamble,
40
CFR
Part
194
is
proposed
to
be
amended
as
follows.

PART
194—
CRITERIA
FOR
THE
CERTIFICATION
AND
RECERTIFICATION
OF
THE
WASTE
ISOLATION
PILOT
PLANT'S
COMPLIANCE
WITH
THE
40
CFR
PART
191
DISPOSAL
REGULATIONS
1.
The
authority
citation
for
Part
194
continues
to
read
as
follows:

Authority:
Pub.
L.
102–
579,
106
Stat.
4777,
as
amended
by
Public
Law
104–
201,
110
Stat.
2422;
Reorganization
Plan
No.
3
of
1970,
35
FR
15623,
Oct.
6,
1970,
5
U.
S.
C.
app.
1;
Atomic
Energy
Act
of
1954,
as
amended,
42
U.
S.
C.
2011–
2296
and
10101–
10270.
2.
Section
194.2,
is
amended
by
adding
definitions
in
alphabetical
order
for
``
acceptable
knowledge''
and
``
minor
alternative
provision''
to
read
as
follows:

§
194.2
Definitions.

*
*
*
*
*
Acceptable
knowledge
means
any
information
about
the
process
used
to
generate
waste,
material
inputs
to
the
process,
and
the
time
period
during
which
the
waste
was
generated,
as
well
as
data
resulting
from
the
analysis
of
waste,
conducted
prior
to
or
separate
from
the
waste
certification
process
authorized
by
EPA's
Certification
Decision,
to
show
compliance
with
Condition
3
of
the
certification
decision
(Appendix
A
of
this
part).
*
*
*
*
*
Minor
alternative
provision
means
an
alternative
provision
to
the
Compliance
Criteria
that
clarifies
a
regulatory
provision,
or
does
not
substantively
alter
the
existing
regulatory
requirements.
*
*
*
*
*
3.
Section
194.6
is
revised
to
read
as
follows:

§
194.6
Alternative
provisions.
The
Administrator
may,
by
rule
pursuant
to
5
U.
S.
C.
553,
substitute
for
any
of
the
provisions
of
this
part
alternative
provisions,
or
minor
alternative
provisions,
in
accordance
with
the
following
procedures:
(a)
Alternative
provisions
may
be
substituted
after:
(1)
Alternative
provisions
have
been
proposed
for
public
comment
in
the
Federal
Register
together
with
information
describing
how
the
alternative
provisions
comport
with
the
disposal
regulations,
the
reasons
why
the
existing
provisions
of
this
part
appear
inappropriate,
and
the
costs,
risks
and
benefits
of
compliance
in
accordance
with
the
alternative
provisions;
(2)
A
public
comment
period
of
at
least
120
days
has
been
completed
and
public
hearings
have
been
held
in
New
Mexico;
(3)
The
public
comments
received
have
been
fully
considered;
and
(4)
A
notice
of
final
rulemaking
is
published
in
the
Federal
Register.
(b)
Minor
alternative
provisions
may
be
substituted
after:
(1)
The
minor
alternative
provisions
have
been
proposed
for
public
comment
in
the
Federal
Register
together
with
information
describing
how
they
comport
with
the
disposal
regulations,
the
reasons
why
the
existing
provisions
of
this
part
appear
inappropriate,
and
the
benefit
of
compliance
in
accordance
with
the
minor
alternative
provision;
(2)
A
public
comment
period
of
at
least
30
days
has
been
completed
for
the
minor
alternative
provisions
and
the
public
comments
received
have
been
fully
considered;
(3)
A
notice
of
final
rulemaking
is
published
in
the
Federal
Register
for
the
minor
alternative
provisions.
4.
Section
194.8
is
amended
by
revising
paragraph
(b)
to
read
as
follows:

§
194.8
Approval
process
for
waste
shipment
from
waste
generator
sites
for
disposal
at
the
WIPP.

*
*
*
*
*
(b)
Waste
Characterization
Programs
at
Transuranic
Waste
Sites.
The
Agency
will
establish
compliance
with
Condition
3
of
the
certification
using
the
following
process.
(1)
DOE
will
implement
waste
characterization
programs
and
processes
in
accordance
with
§
194.24(
c)(
4)
to
confirm
that
the
total
amount
of
each
waste
component
that
will
be
emplaced
in
the
disposal
system
will
not
exceed
the
upper
limiting
value
or
fall
below
the
lower
limiting
value
described
in
the
introductory
text
of
paragraph
(c)
of
§
194.24.
Waste
characterization
processes
will
include
the
collection
and
use
of
acceptable
knowledge;
destructive
and/
or
nondestructive
techniques
for
identifying
and
measuring
waste
components;
and
the
validation,
control,
and
transmittal
to
the
WIPP
Waste
Information
System
database
of
waste
characterization
data,
in
accordance
with
§
194.24(
c)(
4).
(2)
The
Agency
will
verify
the
compliance
of
waste
characterization
programs
and
processes
identified
in
paragraph
(b)(
1)
of
this
section
using
the
following
process.
(i)
DOE
will
notify
EPA
by
letter
that
a
transuranic
waste
site
is
prepared
to
ship
waste
to
the
WIPP
and
has
established
adequate
waste
characterization
processes
and
programs.
DOE
also
will
provide
the
relevant
waste
characterization
program
plans
and
documentation.
EPA
may
request
additional
information
from
DOE.
(ii)
EPA
will
conduct
a
baseline
inspection
at
the
site
to
verify
that
adequate
waste
characterization
program
plans
and
technical
procedures
have
been
established,
and
that
those
plans
and
procedures
are
effectively
implemented.
The
inspection
will
include
a
demonstration
or
test
by
the
site
of
the
waste
characterization
processes
identified
in
paragraph
(b)(
1)
of
this
section.
If
an
inspection
does
not
lead
to
approval,
we
will
a
send
an
inspection
report
to
DOE
identifying
deficiencies
and
place
the
report
in
the
public
docket
described
in
§
194.67.
More
than
one
inspection
may
be
necessary
to
resolve
compliance
issues.
(iii)
The
Agency
will
announce
in
the
Federal
Register
a
proposed
Baseline
Compliance
Decision
to
accept
the
site's
compliance
with
§
194.24(
c)(
4).
In
the
notice,
we
will
solicit
public
comment
on
the
relevant
inspection
report(
s)
and
any
supporting
materials,
which
will
be
placed
in
the
public
docket
described
in
§
194.67.
The
proposal
will
describe
any
limitations
on
approved
waste
streams
or
waste
characterization
processes
and
identify
(through
tier
designations)
what
changes
to
the
approved
waste
characterization
processes
must
be
reported
to
and
approved
by
EPA
before
they
can
be
implemented.
(iv)
Our
written
decision
regarding
compliance
with
the
requirements
for
waste
characterization
programs
and
processes
described
in
paragraph
(b)(
1)
of
this
section
will
be
conveyed
in
a
letter
from
the
Administrator's
authorized
representative
to
DOE.
EPA
will
not
issue
a
compliance
decision
until
after
the
end
of
the
public
comment
period
described
in
paragraph
(b)(
2)(
iii)
of
this
section.
EPA's
compliance
decision
will
respond
to
significant
and
timely
received
comments.
A
copy
of
our
compliance
decision
will
be
placed
in
the
public
docket
described
in
§
194.67.
DOE
will
comply
with
any
requirements
identified
in
the
compliance
decision
and
the
accompanying
inspection
report.
(3)
Subsequent
to
any
positive
determination
of
compliance
as
described
in
paragraph
(b)(
2)(
iv)
of
this
section,
the
Agency
intends
to
conduct
inspections,
in
accordance
with
§
194.24(
h),
to
confirm
the
continued
compliance
of
approved
waste
characterization
programs
and
processes
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51946
Federal
Register
/
Vol.
67,
No.
154
/
Friday,
August
9,
2002
/
Proposed
Rules
at
transuranic
waste
sites.
EPA
will
make
the
results
of
these
inspections
available
to
the
public
in
the
dockets
described
in
§
194.67.
(i)
If
the
Agency
determines,
at
a
subsequent
inspection
of
an
approved
transuranic
waste
site,
that
waste
characterization
programs
or
processes
are
not
adequately
established
or
implemented,
then
we
may
suspend
shipments
and
disposal
of
affected
and
potentially
affected
waste
streams,
or
take
other
action
in
accordance
with
§
194.4(
b)(
1)
and
(2),
until
we
determine
that
the
deficiencies
have
been
adequately
resolved.
(ii)
[Reserved]
5.
Section
194.12
is
revised
to
read
as
follows:

§
194.12
Submission
of
compliance
applications.

Unless
otherwise
specified
by
the
Administrator
or
the
Administrator's
authorized
representative,
5
copies
of
any
compliance
application(
s),
any
accompanying
materials,
and
any
amendments
thereto
shall
be
submitted
in
a
printed
form
to
the
Administrator's
authorized
representative.
In
addition,
DOE
shall
submit
10
copies
of
the
complete
application
in
alternative
format
(e.
g.,
compact
disk)
or
other
approved
format,
as
specified
by
the
Administrator's
authorized
representative.
6.
Section
194.13
is
revised
to
read
as
follows:

§
194.13
Submission
of
reference
materials.

Information
may
be
included
by
reference
into
compliance
applications(
s),
provided
that
the
references
are
clear
specific
and
that
unless,
otherwise
specified
by
the
Administrator
or
the
Administrator's
authorized
representative,
5
copies
of
reference
information
are
submitted
to
the
Administrator's
authorized
representative.
Reference
materials
that
are
widely
available
in
standard
text
books
or
reference
books
need
not
to
be
submitted.
Whenever
possible,
DOE
shall
submit
10
copies
of
reference
materials
in
alternative
format
(e.
g.,
compact
disk)
or
other
approved
format,
as
specified
by
the
Administrator's
authorized
representative.
7.
Section
194.24
is
amended
by
revising
paragraph
(c)(
3)
to
read
as
follows:

§
194.24
Waste
characterization.

*
*
*
*
*
(c)
*
*
*
(3)
Provide
information
that
demonstrates
that
the
use
of
acceptable
knowledge
to
quantify
components
in
waste
for
disposal
conforms
with
the
quality
assurance
requirements
of
§
194.22.
*
*
*
*
*

[FR
Doc.
02–
19796
Filed
8–
8–
02;
8:
45
am]

BILLING
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