United
States
Air
and
Radiation
EPA
402­
R­
04­
003
Environmental
Protection
(
6602J)
March
2004
Agency
______________________________________________________________________________

Criteria
for
the
Certification
and
Re­
Certification
of
the
Waste
Isolation
Pilot
Plant's
Compliance
with
the
40
CFR
Part
191
Disposal
Regulations;
Alternative
Provisions
Response
to
Comments
Document
for
the
Proposed
Alternative
Provisions
to
40
CFR
Part
194
RESPONSE
TO
COMMENTS
40
CFR
Part
194:
Criteria
for
the
Certification
and
Re­
Certification
of
the
Waste
Isolation
Pilot
Plant's
Compliance
with
the
40
CFR
Part
191
Disposal
Regulations
December
2003
Office
of
Radiation
and
Indoor
Air
U.
S.
Environmental
Protection
Agency
Washington,
D.
C.
3
INTRODUCTION
The
Waste
Isolation
Pilot
Plant
(
WIPP)
is
a
deep
geologic
repository
in
use
for
the
disposal
of
transuranic
radioactive
waste.
The
facility,
operated
by
the
Department
of
Energy
(
DOE),
is
subject
to
compliance
with
40
CFR
Part
191,
Environmental
Standards
for
the
Management
and
Disposal
of
Spent
Nuclear
Fuel,
High­
Level
and
Transuranic
Radioactive
Wastes
(
hereafter
"
radioactive
waste
disposal
regulations"
or
"
disposal
regulations")
promulgated
by
the
U.
S.
Environmental
Protection
Agency
(
EPA
or
"
The
Agency").
In
1992
Congress
enacted
the
Waste
Isolation
Pilot
Plant
Land
Withdrawal
Act
(
WIPP
LWA),
which
called
for
EPA
to
issue
final
radioactive
waste
disposal
regulations,
to
issue
criteria
for
determining
whether
the
WIPP
complies
with
the
radioactive
waste
disposal
regulations
and
for
certifying
whether
the
WIPP
facility
in
fact
will
comply
with
the
disposal
regulations.
(
WIPP
LWA
§
8,
Pub.
L.
No.
102­
599,
as
amended
by
Pub.
L.
No.
104­
201).

The
compliance
criteria,
codified
at
40
CFR
Part
194,
explains
the
basis
on
which
the
Agency
evaluates
whether
the
DOE's
WIPP
facility
complies
and
continues
to
comply
with
the
disposal
regulations
of
40
CFR
Part
191.
The
WIPP
LWA
calls
for
specific
criteria
in
implementing
the
general
disposal
regulations
at
the
WIPP
facility.
This
rule
 
the
Alternative
Provisions
to
40
CFR
Part
194
 
will
revise
certain
portions
of
the
Compliance
Criteria
based
on
EPA's
extensive
WIPP
oversight
experience.

BACKGROUND
Radioactive
Waste
Disposal
Regulations:
40
CFR
Part
191
EPA
has
the
responsibility
of
promulgating
the
Federal
environmental
standards
for
spent
nuclear
fuel,
high­
level,
and
transuranic
radioactive
wastes.
Standards
for
disposal
were
first
promulgated
in
1985
and
were
challenged
in
the
U.
S.
Court
of
Appeals.
The
U.
S.
Court
of
Appeals
for
the
First
Circuit
remanded
40
CFR
part
191,
subpart
B,
to
the
Agency
for
further
consideration.
See
NRDC
v.
EPA,
824
F.
2d
1258
(
1st
Cir.
1987).
Section
8
of
the
WIPP
LWA
reinstated
the
1985
disposal
standards,
Subpart
B,
except
those
portions
that
were
the
subject
of
the
judicial
remand.
Section
8
of
the
WIPP
LWA
also
required
the
Agency
to
issue
final
disposal
standards,
to
address
the
issues
that
were
the
subject
of
the
remand.
Final
amendments
were
published
in
the
Federal
Register
on
December
20,
1993
(
58
FR
66397).

WIPP
Compliance
Criteria:
40
CFR
Part
194
As
noted,
the
WIPP
LWA
requires
EPA
to
promulgate
"
Compliance
Criteria"
to
implement
the
disposal
regulations
specifically
for
WIPP.
See
WIPP
LWA
§
8(
c).
The
Agency
published
an
Advance
Notice
of
Proposed
Rulemaking
(
ANPR)
regarding
this
criteria
in
the
Federal
Register
on
February
11,
1993
(
58
FR
8029).

The
proposed
WIPP
Compliance
Criteria
were
published
in
the
Federal
Register
on
January
30,
4
1995
(
60
FR
5766).
The
EPA
held
a
public
comment
period
of
nearly
150
days.
In
addition,
public
hearings
were
held
in
Carlsbad,
Albuquerque,
and
Santa
Fe,
New
Mexico
in
March
1995.
See
60
FR
11060.

EPA
issued
the
final
WIPP
compliance
criteria
in
the
Federal
Register
on
February
9,
1996.
See
61
FR
5224.

Certification
of
Compliance
The
radioactive
waste
disposal
regulations
establish
general
standards
that
apply
to
the
disposal
of
spent
nuclear
fuel,
high­
level
or
transuranic
radioactive
wastes.
The
regulations
require
affected
disposal
systems
to
analyze
their
performance
over
10,000
years
and
to
predict
releases
of
waste
relative
to
specific
containment
requirements,
to
assess
potential
radiation
doses
received
by
individuals
and
through
ground
water,
and
to
address
assurance
requirements
intended
to
provide
the
confidence
needed
for
long­
term
compliance
with
the
containment
requirements.
Under
section
8(
d)(
1)
of
the
WIPP
LWA,
DOE
was
required
to
submit
to
EPA
an
application
for
certification
of
compliance.
Section
8(
d)(
2)
required
EPA
to
determine,
by
rule,
whether
DOE's
application
demonstrated
that
the
WIPP
facility
would
comply
with
the
radioactive
waste
disposal
regulations.
These
regulations
were
outlined
and
explained
in
the
WIPP
Compliance
Criteria
at
40
CFR
Part
194.
The
EPA
approved
DOE's
application
and
issued
a
final
certification
decision
in
the
Federal
Register
on
May
18,
1998
(
67
FR
27353).
This
certification
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
120­
day
comment
period.

Alternative
Provisions
to
40
CFR
Part
194
Based
on
extensive
oversight
experience
with
the
WIPP,
EPA
proposed
to
revise
certain
provisions
of
the
Compliance
Criteria
at
40
CFR
Part
194.
Specifically,
EPA
proposed
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
transuranic
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
revisions
will
maintain
or
improve
our
oversight
at
WIPP
to
ensure
safe
disposal
and
are
intended
to
ensure
that
40
CFR
Part
194
remains
comprehensive,
appropriate,
and
based
upon
current
knowledge
and
information.
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
issued
the
proposed
revisions
in
the
Federal
Register
on
August
9,
2002.
The
Agency
held
a
comment
period
for
120
days.
In
addition,
public
hearings
were
held
in
Albuquerque
and
Santa
Fe,
NM
on
September
24­
25,
2002.
See
67
FR
57189
(
September
9,
2002;
notice
of
public
5
hearings).
The
Agency
published
newspaper
ads
in
Carlsbad,
Albuquerque,
and
Santa
Fe,
NM,
to
announce
the
dates,
times,
and
locations
of
the
hearings.
EPA
also
posted
updated
information,
fact
sheets,
and
messages
regarding
the
proposed
revisions
on
the
WIPP
website
(
http://
www.
epa.
gov/
radiation/
wipp)
and
on
the
toll­
free
WIPP
Information
Line
to
facilitate
communication
with
the
public.

Approximately
17
sets
of
comments
 
seven
from
the
public
hearings,
four
from
EDOCKET,
and
six
through
e­
mail/
regular
mail
 
were
submitted
to
EPA
regarding
the
proposed
WIPP
Compliance
Criteria.
Comments
received
on
the
proposal
were
categorized
according
to
the
following
topics,
most
of
which
correspond
generally
to
sections
of
the
proposed
rule:

°
General
observations
°
EPA's
public
hearing
process
°
Minor
alternative
provisions
°
Proposed
inspection
regime
°
Submission
of
compliance
and
reference
materials
°
"
Acceptable
Knowledge"
definition
While
a
section
of
this
document
is
assigned
to
each
topic,
the
document
should
be
read
comprehensively.
Some
comments
presented
overlapping
issues,
while
others
contain
several
points,
and
some
comments
repeat
points
that
are
addressed
elsewhere
within
a
particular
section
or
in
a
wholly
different
section.
While
in
some
instances
EPA
has
cross­
referenced
related
responses,
it
has
not
done
so
in
every
instance.
Thus,
the
responses
to
comments
set
out
in
this
document
should
not
be
read
in
isolation.
Rather,
the
entire
document
should
be
considered
as
a
whole,
for
it
collectively
reflects
EPA's
consideration
of
significant
comments.

This
document
addresses
comments
received
on
the
proposed
alternative
provisions
to
40
CFR
Part
194
by
summarizing
the
concerns
expressed
by
commenters
and
presenting
the
Agency's
response
to
the
comments.
The
Agency
has
addressed
all
significant
comments,
both
written
and
oral.

Each
set
of
comments
submitted
to
EPA
is
identified
by
a
numeric/
alphabetic
code
indicating
its
source.
A
list
of
the
commenters
and
their
identification
is
given
in
Appendix
A.
Copies
of
all
comments
submitted
to
EPA
regarding
the
proposed
rule
can
be
found
in
Air
Docket
Number
A­
98­
49
(
Categories
VI­
C
and
VI­
D)
and
also
online
at
EDOCKET
#
OAR­
2002­
0005
(
excluding
the
oral
testimony
from
the
public
hearings).
For
more
information
on
docket
locations,
refer
to
the
Federal
Register
notice
for
the
proposed
or
final
rule.
A
list
of
acronyms
and
the
terms
they
represent
are
in
Appendix
B.
6
ISSUE
#
1:
GENERAL
OBSERVATIONS
FROM
COMMENTERS
1­
7.
We
support
many
aspects
of
the
EPA's
proposed
changes
to
40
CFR
Part
194.
The
changes
enhance
the
flexibility
EPA
desires
in
its
verification
of
the
transuranic
waste
sites
compliance
with
the
disposal
regulations,
and
should
reduce
the
number
of
inspections
required.
(
DOE)

1­
2.
As
a
whole,
the
revisions
suggested
are
very
good.
Anything
that
speeds
up
the
process
and
makes
it
more
efficient
is
a
good
idea.
(
RW)

1­
3.
Overall,
the
proposed
changes
to
40
CFR
Part
194
are
a
step
in
the
right
direction
and
will
help
the
generator
sites
be
able
to
demonstrate
adequate
compliance.
It
will
also
give
the
public
a
better
opportunity
to
provide
comment
on
the
potential
ruling
or
potential
certification
that
those
sites
will
endure
as
opposed
to
the
comment
period
being
prior
to
the
actual
inspection;
a
win­
win
situation
for
everyone.
(
WTS)

Response
to
Comments
1­
1
through
1­
3:
EPA
believes
the
changes
will
make
the
inspections
process
at
DOE
waste
generator
sites
more
effective
and
efficient
while
maintaining
safe
oversight
of
disposal
operations.
And
while
the
amendments
improve
EPA
and
public
participation
processes,
EPA
is
maintaining
underlying
rigorous
waste
characterization
and
other
requirements
that
the
WIPP
must
meet.
Furthermore,
EPA
can
more
easily
make
minor
revisions
in
the
future
to
similarly
keep
pace
with
technological
information
and
changing
practices.
These
changes
will
improve
implementation
of
key
provisions
of
the
WIPP
Compliance
Criteria.
Also,
the
amendments
allow
for
electronically
submitted
information,
which
can
be
more
easily
reviewed
and
made
available
to
the
public.

1­
4.
I
am
not
satisfied
that
the
public
is
really
being
heard
by
either
EPA
or
DOE.
The
only
real
way
to
solve
all
of
these
contamination­
related
concerns
is
to
stop
producing
nuclear
weapons
and
nuclear
waste.
That
should
be
the
foremost
item
on
EPA's
agenda.
(
RL)

Response
to
Comment
1­
4:
At
the
time
Congress
withdrew
the
WIPP
site
from
public
domain,
Congress
delegated
certain
regulatory
responsibilities
to
EPA
(
WIPP
Land
Withdrawal
Act,
Sections
8
and
9).
The
issuance
of
the
WIPP
Compliance
Criteria
at
40
CFR
194
is
among
those
responsibilities
and
the
amendment
of
the
Criteria
are
within
EPA's
authority.
Congress
did
not
delegate
to
EPA
the
authority
to
abandon
WIPP
or
dictate
other
disposal
options
because
it
might
affect
other
defense
activities
related
to
radioactive
waste
or
atomic
weapons.
These
considerations
are
outside
the
scope
of
this
rulemaking.

1­
5.
We
suggest
that
EPA
establish
approval,
certification
procedures,
and
criteria
separate
to
the
194
rule
and
have
it
apply
in
a
more
global
sense
to
both
high­
level
waste
and
transuranic
waste
for
any
geologic
facility.
This
is
something
for
EPA
to
consider
in
the
future.
(
WTS)
7
Response
to
Comment
1­
5:
The
WIPP
Land
Withdrawal
Act
authorized
EPA
to
establish
compliance
criteria
only
related
to
the
WIPP
facility
(
which
EPA
outlined
in
40
CFR
194).
The
establishment
of
criteria
for
other
geologic
disposal
facilities
is
outside
the
scope
of
this
rulemaking.

1­
6.
EPA
should
incorporate,
review,
and
respond
to
the
concerns
raised
in
EEG's
September
2002
entitled
"
Identification
of
Issues
Relevant
to
the
First
Recertification
of
WIPP,"
EEG
­
83.
Although
these
issues
are
not
directly
related
to
the
proposed
rule,
they
are
nonetheless
concerns
for
the
people
of
New
Mexico.
(
CCNS)

1­
7.
DOE's
July
2002
WIPP
Performance
Management
Plan
(
PMP)
documented
talks
of
bringing
in
waste
to
the
WIPP
in
an
accelerated
manner.
The
document
lays
out
more
waste
to
WIPP
in
the
next
five
years
than
what
was
anticipated.
EPA
should
consider
the
PMP
in
the
recertification
process.
(
CCNS)

Response
to
Comments
1­
6
and
1­
7:
Although
EPA
agrees
these
issues
are
important,
they
are
beyond
the
scope
of
this
proposed
rulemaking.
These
issues
will
be
addressed
during
the
recertification
process,
as
appropriate.

1­
8.
We
are
concerned
about
transportation
issues
(
shipment
of
the
waste
to
the
WIPP),
especially
when
driven
in
through
commercial
highways.
(
CCNS)

1­
9.
The
transportation
of
waste
to
the
WIPP
is
very
important
and
I
am
aware
of
two
recent
accidents.
The
EPA
should
also
think
about
spending
their
money
on
emergency
management
training
in
localities
and
municipalities.
(
RL)

Response
to
Comments
1­
8
and
1­
9:
These
comments
are
beyond
the
scope
of
this
proposed
rulemaking.
As
stated
during
the
original
WIPP
Certification,
transportation
is
entirely
outside
EPA's
general
authority
for
regulating
radioactive
waste.
Moreover,
in
the
WIPP
Land
Withdrawal
Act,
Congress
did
not
authorize
any
role
for
EPA
with
respect
to
transportation.
Transportation
of
radioactive
waste
is
regulated
by
the
Nuclear
Regulatory
Commission,
the
U.
S.
Department
of
Transportation,
and
the
State
of
New
Mexico.
All
transportation
requirements
for
the
WIPP
are
established
and
enforced
by
regulators
other
than
EPA,
and
the
Agency
has
no
regulatory
authority
to
affect
transportation
routes
or
requirements.

1­
10.
A
company's
compliance
record,
including
any
instances
of
non­
compliance,
fines
and
penalties,
should
be
used
to
determine
accountability
and
justification
for
recertification.
(
ANON1)

1­
11.
I
just
can't
believe
we
allow
recycling
of
hazardous
waste
into
fertilizers
to
place
on
crops
we
plan
to
eat
later.
(
ANON2)

1­
12.
Waste
treatment
of
TiO2,
HF,
V3O5,
CoO2
water
based
solution.
(
SM)
8
Response
to
Comments
1­
10
through
1­
12:
These
comments
fall
beyond
the
scope
of
this
rulemaking.

ISSUE
#
2:
EPA'S
PUBLIC
HEARING
PROCESS
 
HELD
ON
SEPTEMBER
24­
25,
2002;
ALBUQUERQUE
&
SANTA
FE,
NEW
MEXICO
2­
1.
The
timing
of
the
hearings
in
Albuquerque
and
Sante
Fe
precluded
most
interested
people
from
being
able
to
participate
because
of
the
large
number
of
WIPP­
related
matters
that
had
nearer
term
deadlines.
This
is
in
contrast
to
the
considerable
turnout
in
past
EPA
rulemaking
hearings.
For
future
rulemakings
or
other
public
processes,
EPA
should
consult
with
leading
citizen
organizations
(
SRIC,
CCNS,
NWNM,
CARD,
etc.)
prior
to
scheduling
any
hearings.
(
SRIC,
NWNM,
CCNS,
CARD)

Response
to
Comment
2­
1:
EPA
understands
and
appreciates
the
time
and
effort
required
by
WIPP
stakeholders
to
meaningfully
participate
in
the
Agency's
public
hearings
and
other
public
fora
and
processes.
Since
the
Office
of
Radiation
and
Indoor
Air
conducted
the
first
public
hearings
in
New
Mexico
in
1993,
our
policy
(
based
on
feedback
from
key
WIPP
stakeholders,
including
commenters)
has
been
to
schedule
public
hearings
midway
through
the
public
comment
period
associated
with
the
rulemaking
action.
This
timing
gives
stakeholders
time
to
review
the
action
in
order
to
prepare
testimony
and
submit
comments
at
the
public
hearing
and
also
allows
time
after
the
hearing
to
submit
additional
written
comments
or
respond
to
issues
raised
in
hearing
testimony
before
the
close
of
the
public
comment
period.
The
public
hearing
dates
selected
for
the
194
Alternative
Provisions
Rulemaking
were
scheduled
based
on
two
factors:
(
1)
facility
availability
in
Albuquerque
and
Santa
Fe,
and
(
2)
implementing
our
public
hearing
time
frame
consistent
with
past
practice.
In
the
future,
EPA
will
seek
greater
coordination
with
stakeholders
to
facilitate
participation
in
hearings.

ISSUE
#
3:
SECTION
194.6
 
PROPOSED
ADDITION
OF
"
MINOR
ALTERNATIVE
PROVISIONS"
AND
CORRESPONDING
PUBLIC
COMMENT
PERIOD
3­
1.
The
EPA
proposes
to
revise
Section
194.6
to
add
a
rulemaking
process
for
substituting
"
minor
alternative
provisions"
of
the
Compliance
Criteria.
As
a
part
of
this
process,
the
EPA
is
proposing
to
reduce
the
comment
period
from
120
days
to
30
days
for
minor
changes.
A
45­
day
comment
period
may
be
more
appropriate
to
make
sure
that
interested
parties
can
submit
comments,
especially
during
periods
which
include
major
holidays.
(
EEG)

3­
2.
Although
it
is
good
that
EPA
maintains
the
public
comment
period
for
minor
changes,
30
days
is
not
sufficient.
60
days
would
be
more
reasonable.
(
SRIC,
CCNS,
NWNM,
CARD)
9
Response
to
Comments
3­
1
and
3­
2:
The
proposal
at
§
194.6(
b)(
2)
states
that
the
Agency
would
give
at
least
30
days
for
the
public
to
comment
on
the
minor
alternative
provisions.
That
gives
the
EPA
flexibility
to
provide
a
longer
comment
period
depending
on
the
complexity
or
controversy
of
an
issue
and
public
response.

EPA
agrees
that
under
certain
circumstances
a
longer
comment
period
is
desirable
but
expects
that
30
days
will
be
sufficient
for
most
minor
changes,
which
are
expected
to
be
largely
administrative
and
uncontroversial.
EPA's
final
rule
specifies
a
minimum
30­
day
comment
period
for
minor
changes.
But,
where
circumstances
warrant,
EPA
will
consider
a
longer
comment
period.

3­
3.
The
proposed
definition
of
"
minor
alternative
provision"
lacks
clarity.
The
following
definition
should
be
used:
"
Minor
alternative
provision
means
an
alternative
provision
to
these
Compliance
Criteria
that
only
clarifies
an
existing
regulatory
provision,
and
does
not
substantively
alter
the
existing
regulatory
requirements."
(
SRIC,
CCNS)

3­
4.
The
"
minor
alternative
provision"
definition
lacks
clarity
and
requires
a
more
substantial
operation
definition,
or
there
could
be
misunderstanding
or
violations
that
lead
to
lawsuits.
(
NWNM)

3­
5.
The
"
minor
alternative
provision"
definition
in
the
proposed
rule
does
not
have
enough
criteria
or
specifics
to
identify
what
is
minor
and
what
is
an
alternative
provision
as
the
former
definition
stands.
Similar
circumstances
with
the
word
have
been
significantly
different,
so
the
EPA
must
be
careful
in
defining
the
term.
However,
overall,
the
revisions
in
Section
194.6
were
a
great
step
in
the
right
direction
delineating
two
portions
 
one
that
could
be
ruled
on
in
a
minimal
amount
of
time
and
another
portion
that
fit
all
other
categories.
(
WTS)

3­
6.
The
definition
of
"
minor
alternative
provision"
is
not
clear
enough.
EPA
or
DOE
may
define
something
as
minor
that
the
public
might
consider
a
moderate
or
major
change.
This
problem
has
already
occurred
several
times
in
the
New
Mexico
RCRA
operating
Permit
Modification
process.
Language
should
be
included
in
the
Final
Rule
that
limits
minor
alternative
provisions
so
that
they
cannot
be
interpreted
to
allow
substantive
changes
to
current
regulations.
(
CARD,
SRIC,
CCNS)

3­
7.
I
commend
EPA
for
accommodating
small
changes
that
are
deemed
as
minor
in
rules.
(
RW)

Response
to
Comments
3­
3
through
3­
7:
We
agree
with
the
commenters'
suggested
changes
to
the
proposed
definition
of
"
Minor
alternative
provision."
We
have
revised
the
proposed
definition
to
emphasize
that
a
minor
alternative
provision
would
only
clarify
an
existing
regulatory
provision
and
not
substantially
alter
the
regulatory
requirements.
Note
that
minor
provisions,
10
while
subject
to
a
streamlined
process,
still
constitute
a
full
regulatory
process
with
a
proposed
rule,
public
comment,
and
final
rule.

3­
8.
The
proposed
rule
change
does
not
clearly
stipulate
a
change
between
40
CFR
Part
194.6(
a)
and
194.6(
b).
If
there
is
a
case
in
which
public
comment
persuades
EPA
to
change
its
decision
on
whether
an
item
is
"
minor"
under
subsection
(
b),
EPA
should
issue
a
notice
of
final
rulemaking
rejecting
the
change
and
then
re­
notice
it
for
public
comment
under
40
CFR
194.6(
a).
Additionally,
EPA
should
include
a
provision
which
states
that
final
determination
will
depend
on
public
comment.
(
SRIC,
CCNS,
NWNM,
CARD)

Response
to
Comment
3­
8:
EPA
believes
that
the
proposed
process
is
adequate
to
address
the
commenters'
concerns.
In
our
proposal,
at
§
194.6,
we
outlined
a
process
that
we
would
follow
to
propose
and
finalize
minor
alternative
provisions.
As
a
regulatory
agency,
EPA
must
seek
public
comment
on
the
proposed
regulations
and
fully
consider
them
when
issuing
a
final
action.
The
only
difference
between
the
language
for
alternative
provisions
under
§
194.6(
a)
and
that
proposed
for
the
minor
alternative
provisions
under
§
194.6(
b)
is
the
length
of
the
comment
period
and
whether
public
hearings
would
be
required.
Depending
on
the
complexity
of
the
issue
and
the
public
reaction,
the
Agency
has
flexibility
and
discretion
to
seek
public
comments
for
a
period
exceeding
the
minimum
required
and
also
to
hold
public
hearings.

ISSUE
#
4:
SECTION
194.8
 
PROPOSED
INSPECTION
REGIME,
TIERED
APPROVAL
PROCESS,
AND
CORRESPONDING
PUBLIC
COMMENT
PERIOD
4­
1.
EPA
should
revise
the
language
proposed
in
Section
194.8(
b)(
2)(
i).
The
proposed
language
reads,
"
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."
The
first
sentence
of
Section
194.8(
b)(
2)(
i)
be
revised
to
read,
"
DOE
will
request,
by
letter,
that
EPA
perform
an
inspection
of
the
waste
characterization
processes
and
programs
at
a
transuranic
waste
site."
This
is
mainly
to
clarify
the
rule
language
and
make
sure
issues
such
as
transportation
programs
at
waste
sites
(
regulated
by
NRC
and
DOE,
not
EPA)
and
audit
approvals
are
not
misrepresented
or
misinterpreted
in
any
way.
(
DOE)

Response
to
Comment
4­
1:
EPA
agrees
that
it
is
helpful
to
clarify
the
scope
of
notifications
(
and
EPA
inspections)
regarding
waste
characterization
programs.
We
have
revised
the
language
in
Section
194.8(
b)(
2)(
1)
as
follows:
"
DOE
will
notify
EPA
by
letter
that
a
transuranic
waste
site
is
prepared
to
demonstrate
the
adequacy
of
its
waste
characterization
program."
The
revised
language
clarifies
that
this
requirement
does
not
refer
to
shipping
of
waste,
which
is
under
the
jurisdiction
of
other
Federal
agencies
 
the
Department
of
Transportation
and
the
Nuclear
Regulatory
Commission.

4­
2.
The
current
process
of
notice
in
the
Federal
Register
(
publishes
site
characterization
plans
11
and
a
30­
day
public
comment
period)
provides
a
better
opportunity
for
public
understanding
and
participation
and
should
be
retained.
A
30­
day
public
comment
period
on
the
proposed
"
Baseline
Compliance
Decision,"
after
EPA
has
completed
its
inspection
and
found
the
operations
to
comply
with
the
regulations,
would
result
in
additional
delay
of
characterization
and
waste
disposal
and
unnecessary
costs
to
the
government
and
public.
As
an
alternative,
EPA
could
approve
a
site
to
characterize
the
waste
for
disposal
at
the
time
of
EPA's
proposed
Baseline
Compliance
Decision
but
have
a
temporary
hold
where
the
characterized
waste
is
retained
at
the
site.
If
EPA
decides
to
go
ahead
and
change
the
rule
as
they
proposed,
the
language
should
specify
a
short
fixed
period
for
accepting
comments
(
no
time
limit
was
discussed
in
the
proposed
rule),
such
as
30
days.
(
DOE)

4­
3.
The
proposed
text
in
Section
194.8(
b)(
2)(
iii)
does
not
describe
the
length
of
the
public
comment
period
on
the
baseline
inspections.
EPA
should
specify
"...
at
least
30
days
to
comment."
We
support
the
proposed
change
to
receiving
public
comment
not
only
on
DOE
documentation
but
also
the
EPA's
baseline
inspection
reports
and
proposed
compliance
decisions.
This
proposed
change
may
attract
more
public
comment,
especially
if
the
electronic
EPA
docket
initiative
is
widely
utilized.
The
EPA
could
also
make
the
results
of
any
Section
194.24
inspections
available
for
comment,
just
as
the
Section
194.8
inspection
reports
and
decisions
will
be
made
available.
(
EEG)

4­
4.
40
CFR
Part
194.8(
b)(
2)(
iii)
should
provide
for
at
least
a
60­
day
public
comment
period.
In
the
language
of
the
proposed
rule,
there
is
no
time
frame
given
for
the
public
comment
period,
although
the
preamble
states
that
there
would
be
a
30­
day
comment
period.
(
SRIC)

4­
5.
We
support
the
idea
of
the
public
being
able
to
comment
on
both
the
DOE
documents
and
on
EPA
inspections
(
including
baseline
inspections
if
this
is
approved).
However,
we
object
to
the
30­
day
limit
on
public
comment
for
the
reasons
previously
described.
These
documents
are
even
more
technical
than
those
involved
in
minor
alternative
provisions
and
would
require
even
more
time
to
study.
(
CARD)

4­
6.
EPA
should
specify
a
maximum
length
for
the
comment
period
to
prevent
unnecessary
delays.
One
of
the
advantages
of
the
waste­
stream­
by­
waste­
stream
process
was
that
a
site
could
ship
some
waste
while
waiting
to
get
another
waste
stream
approved.
If
there
is
no
mechanism
to
prevent
these
extensions,
there
could
be
sites
that
will
simply
be
bottled
up
and
prevented
from
shipping
anything
for
indefinite
periods
of
time.
(
RW)

Response
to
Comments
4­
2
through
4­
6:
EPA's
proposed
rule
language
did
not
address
the
length
of
the
public
comment
period.
However,
the
preamble
to
the
proposal
discussed
a
30­
day
comment
period
(
67
FR
51936).
Several
comments
requested
a
comment
period
longer
than
the
30
days
mentioned
in
the
proposed
preamble.
During
this
period,
the
public
could
review
and
comment
on
EPA's
Baseline
Compliance
Decision,
tiering
designations,
inspection
reports,
and
12
relevant
DOE
technical
documents.
Some
of
these
documents
could
be
lengthy
and
highly
technical,
and
EPA
agrees
that
a
very
short
comment
period
might
discourage
public
comment.
Therefore,
in
the
final
rule,
§
194.8(
b)(
2)(
iii)
establishes
a
45­
day
comment
period
on
EPA's
Baseline
Compliance
Decision.
At
our
discretion,
EPA
may
extend
the
comment
period
on
a
case­
by­
case
basis.
At
the
end
of
the
comment
period,
EPA
will
consider
public
comments
received
and
issue
a
final
approval
decision
letter.
We
plan
to
post
these
baseline
decisions
on
EPA's
WIPP
website,
and
hard
copies
of
this
relevant
documentation
and
other
information
will
be
available
at
our
dockets
in
Washington,
DC,
and
Albuquerque,
Carlsbad,
and
Santa
Fe,
NM.
Interested
parties
will
have
the
option
of
submitting
comments
to
the
EDOCKET
as
well.
Also
note
that
EPA
will
docket
and
post
on
the
WIPP
website
material
relevant
to
§
194.24
inspections
for
public
review
without
a
set
comment
period.
The
public
may
submit
comments
relating
to
these
inspections
and
EPA
will
consider
them
as
appropriate.

EPA
does
not
agree
that
seeking
public
comment
on
the
Agency's
approval
decision
may
cause
excessive
delay
in
waste
shipment
or
incur
unreasonable
storage
costs.
In
the
proposed
rule,
we
have
provided
that
transuranic
(
TRU)
waste
sites
with
approved
WC
programs
could
continue
to
characterize
the
approved
waste
streams
for
WIPP
disposal
while
EPA
converts
to
the
new
inspection
system.
Thus,
EPA's
baseline
inspections
and
final
approval
at
the
end
of
the
comment
period
would
have
no
impact
on
the
disposal
schedule
for
currently
approved
sites.
We
believe
that
the
TRU
waste
sites
that
have
not
been
approved
to
date
can
reasonably
adjust
their
characterization
and
disposal
schedule
to
incorporate
the
time
necessary
for
EPA
inspection(
s),
comment
period,
and
a
final
approval
letter
and
can
plan
for
necessary
storage.
Approved
DOE
sites
awaiting
EPA
approval
of
a
"
new"
waste
stream
or
a
waste
summary
category
group
can
do
the
same.
During
the
time
interval
between
inspection
and
approval
decision,
DOE
sites
may
choose
to
continue
waste
characterization
activities
with
an
understanding
that
they
may
be
subject
to
a
follow­
up
inspection
or
even
disapproval
if
EPA,
upon
consideration
of
public
comment,
makes
such
a
determination.

4­
7.
EPA
should
conduct
the
baseline
inspections
of
transuranic
waste
sites
with
current
approval
when
DOE
conducts
the
annual
recertification
audits.
The
practice
of
concurrent
audits
between
EPA
and
DOE
has
been
beneficial
to
both
parties.
(
DOE)

Response
to
Comment
4­
7:
EPA
intends
to
conduct
the
baseline
inspections
at
the
five
approved
sites
within
a
reasonable
period
after
the
proposed
changes
take
effect.
These
inspections
may
or
may
not
coincide
with
DOE's
annual
re­
certification
audits.

EPA
agrees
that
conducting
concurrent
audits
with
DOE's
Quality
Assurance
(
QA)
organization
has
been
beneficial
in
the
past
and
the
proposed
rule
acknowledged
these
benefits.
The
baseline
inspections
as
envisioned
would
be
more
comprehensive
as
EPA
inspectors
would
be
establishing
tiers
for
all
waste
characterization
components
and
potential
waste
streams,
requiring
thorough
evaluation
of
processes,
procedures,
and
equipment
and
discussions
with
waste
characterization
(
WC)
personnel.
The
process
may
require
longer
than
the
customary
3­
day
WIPP
audits
performed
by
DOE.
EPA
has
the
authority
to
conduct
independent
inspections
at
TRU
waste
13
sites
and
intends
to
work
directly
with
sites
to
schedule
and
conduct
these
inspections.
EPA
may
invite
DOE's
QA
organization
and
National
TRU
Program
staff
as
observers.
To
make
efficient
use
of
resources,
when
possible
we
will
attempt
to
schedule
concurrent
or
partially
concurrent
inspections.

4­
8.
The
current
inspection
requirements
and
process
is
excessive.
However,
as
an
alternative
to
the
proposed
changes
outlined
in
the
proposed
rule,
the
baseline
inspections
could
be
conducted
at
each
site
for
each
of
the
three
waste
summary
category
groups
(
or
for
as
many
groups
as
are
associated
with
a
site).
This
is
because
characterization
methods
are
likely
to
be
applied
differently
to
each
group,
and
the
EPA
should
tailor
its
approval
process
to
cover
these
three
major
physical
forms
as
separate
processes.
(
EEG)

Response
to
Comment
4­
8:
EPA
agrees
that
it
is
important
to
fully
examine
how
waste
characterization
is
applied,
and
that
there
may
be
meaningful
distinctions
between
the
waste
summary
category
groups
in
this
regard.
The
proposed
baseline
inspection
and
tiering
process
can
fully
accommodate
separate
consideration
of
summary
categories
if
there
are
significant
differences
in
WC
processes.
Section
IV.
B
of
the
preamble
to
the
final
rule
clarifies
the
approval
process.
Briefly,
each
TRU
waste
site
must
demonstrate
the
adequacy
of
the
site's
waste
characterization
program
for
approval
by
characterizing
a
sufficient
number
of
TRU
waste
containers
belonging
to
a
particular
waste
stream
or
the
waste
summary
category.
During
EPA
inspections,
we
will
evaluate
the
adequacy
of
the
program
by
assessing
whether
the
site
can
successfully
characterize
the
waste
and
meet
the
WIPP
waste
acceptance
criteria.
The
baseline
approval
of
TRU
WC
processes
and
equipment
would
depend
solely
on
the
site's
ability
to
demonstrate
whether
the
given
process,
procedure,
or
equipment
can
be
used
to
characterize
one
or
several
waste
streams
or
waste
summary
categories.
The
baseline
approval
under
§
194.8
will
specify
any
limitations
on
the
approval.
Limitations
may
relate
to
waste
streams,
waste
categories,
processes,
or
other
factors
deemed
important
by
EPA.
The
baseline
approval
will
also
specify,
through
tiering
designations,
what
level
of
EPA
review
and
approval
is
necessary
for
future
changes
or
expansions
to
the
WC
program
at
a
site
(
including,
for
example,
expanding
the
program
to
encompass
new
waste
streams).
This
approach
allows
for
limits
on
waste
stream
characterization
where
meaningful,
but
provide
flexibility
for
EPA
to
establish
limits
on
other
criteria
which
may
be
more
technically
important
at
a
given
site.

4­
9.
A
maximum
time
period
should
be
specified
for
which
the
site
baseline
inspection
is
valid,
or
a
maximum
time
between
inspection
conducted
under
Section
194.24.
A
two
to
three
year
maximum
may
be
appropriate.
(
EEG)

4­
10.
We
object
to
the
open­
ended
nature
of
the
proposed
194.8(
b).
The
WIPP
site
is
supposed
to
operate
for
35
years
and
safely
contain
radionuclides
for
10,000
years
 
a
one­
time
approval
of
waste
characterization
practices
would
be
unsafe
and
irresponsible.
Thus,
any
baseline
decision
should
be
limited
by
rule
to
no
more
than
a
specified
number
of
years,
preferably
no
more
than
three
years.
Thus,
the
baseline
would
need
to
be
reviewed
and
updated
at
appropriate
intervals.
(
SRIC)
14
4­
11.
We
object
to
the
proposed
changes
in
Section
194.8,
mainly
with
the
provision
that
states
waste
generator
sites
will
require
only
one
194.8
approval
for
all
waste
streams
indefinitely.
This
is
entirely
unacceptable,
as
this
reduction
in
required
approvals
is
potentially
reducing
oversight
and
enforcement
of
DOE
sites.
(
NWNM,
CCNS,
CARD)

Response
to
Comments
4­
9
through
4­
11:
The
comments
indicate
that
EPA
did
not
make
sufficiently
clear
the
nature
and
purpose
of
the
proposed
regulatory
changes.
EPA
does
not
believe
that
the
proposed
changes
would
reduce
either
the
number
of
inspections
nor
the
level
of
oversight
and
enforcement
at
DOE
sites.
The
changes
will
modify
the
EPA
inspection
and
approval
procedures,
but
will
not
necessarily
affect
the
frequency
or
number
of
times
a
site
will
be
inspected.
Under
40
CFR
194,
EPA
may
inspect
DOE
TRU
sites'
waste
characterization
activities
using
the
inspection
authority
under
§
194.8
and
§
194.24.
The
new
process
provides
that
the
individual
waste
generator
sites
will
need
only
one
§
194.8
approval
from
EPA
to
conduct
WC
activities.
However,
this
single
§
194.8
approval
will
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.
Limitations
on
the
initial
§
194.8
approval
may
relate
to
waste
streams,
waste
categories,
processes,
or
other
factors
deemed
important
by
EPA
and
will
specify
what
WC
program
expansions
or
changes
must
undergo
further
EPA
inspection
or
approval
under
§
194.24.
For
Tier
1
activities
(
which
could
include,
for
example,
the
use
of
a
new
waste
characterization
process
not
previously
applied
to
any
waste
streams
at
a
site),
DOE
must
notify
and
obtain
EPA
approval
in
advance
of
sending
waste
to
WIPP
that
was
characterized
with
the
new
method.
The
EPA
would
expect
to
conduct
on­
site
inspections
to
evaluate
many
Tier
1
activities.
Furthermore,
EPA's
proposed
Baseline
Compliance
Decision,
including
any
proposed
limitations,
will
be
subject
to
public
comment.

The
Agency
does
not
agree
that
it
is
necessary
to
require
a
re­
evaluation
of
EPA's
site­
specific
Baseline
Compliance
Decisions
at
a
set
interval.
As
discussed
in
the
preamble
to
the
proposed
rule
and
reiterated
above,
EPA
will
conduct
additional
site
inspections
under
§
194.24
to
verify
continued
compliance
with
the
baseline
approval
in
accordance
with
the
tiering
designations
or
as
otherwise
deemed
necessary.
Since
1998,
EPA
has
inspected
WC
programs
at
TRU
waste
sites
under
§
194.24
on
an
approximately
annual
basis;
generally
the
Agency
has
conducted
these
inspections
to
coincide
with
DOE's
annual
recertification
audits.
We
are
likely
to
maintain
at
least
the
same
frequency
for
future
continued
compliance
inspections
under
§
194.24
and
may
inspect
more
frequently
as
Tier
1
activities
warrant
(
i.
e.,
if
DOE
undertakes
specified
expansions
or
changes
to
the
approved
WC
program).
A
reduced
frequency
of
inspections
might
also
be
warranted
if,
for
example,
a
site
has
no
characterization
activity
over
a
period
of
time.
The
final
rule
offers
flexibility
in
scheduling
inspections
as
necessary
while
not
diminishing
in
any
way
the
effectiveness
of
our
inspections
program.

Because
EPA
expects
to
continue
to
inspect
sites
regularly,
we
do
not
believe
it
is
necessary
to
specify
an
expiration
date
for
the
baseline
compliance
approval.
Through
ongoing
compliance
inspections
(
prompted
by
tiered
activities/
changes
at
the
site
or
at
EPA's
own
discretion
under
15
§
194.24),
EPA
will
validate
that
approved
processes
and
equipment
continue
to
be
adequately
implemented.
The
baseline
approval
will
remain
valid
so
long
as
the
site
continues
to
demonstrate
appropriate
use
of
approved
processes.

EPA
expects
that
the
baseline
compliance
inspections
and
approval
process
will
be
more
wideranging
than
the
current
inspection
regime
since
it
will
not
be
limited
by
waste
stream
designations
and
will
explicitly
address
future
expansions
of
the
characterization
program.
The
first
approvals
conducted
under
the
new
process
are
likely
to
be
highly
detailed
and
very
intensive,
since
EPA
will
need
to
work
with
DOE
and
stakeholders
to
ensure
that
the
full
range
of
waste
characterization
activities
is
identified
and
placed
in
appropriate
reporting/
approval
tiers.
The
final
rule
provides
important
flexibility
to
ensure
that
EPA
can
effectively
implement
 
and
that
the
public
can
fully
understand
and
participate
in
 
the
new
process.
The
final
rule
does
not
establish
a
time
period
within
which
EPA
must
"
convert"
sites
to
the
new
inspections
and
approval
process.
DOE
sites
with
approved
waste
characterization
programs
will
be
allowed
to
continue
operations
under
the
existing
inspection
and
approval
process
based
on
waste
streams;
the
waste
stream
system,
while
less
flexible
than
the
newly
revised
process,
remains
rigorous
and
can
continue
to
provide
effective
oversight
during
the
transition
period.
We
expect
to
review
approved
programs
and
issue
new
baseline
approval
decisions
for
those
sites
within
approximately
two
years.
However,
the
Agency
retains
the
discretion
to
take
longer
(
if
warranted)
by
the
complexity
of
technical
issues
or
the
scope
of
more
comprehensive
inspections.
Similarly,
we
decline
to
limit
the
length
of
the
comment
period
on
proposed
baseline
approval
decisions.
We
believe
that
limiting
the
available
comment
period
would
be
counterproductive
for
both
EPA
and
the
public
in
adjusting
to
the
new
process,
and
could
constrain
discussion
if
unanticipated
or
especially
complex
issues
arise.

The
results
of
all
EPA
site
inspections,
under
§
194.8
and
§
194.24,
will
be
made
available
to
the
public
in
EPA's
dockets,
WIPP
website,
and
other
means.
If,
at
any
time,
we
determine
that
the
system
of
controls
at
a
site
is
not
adequate
to
characterize
certain
waste
streams,
EPA
retains
authority
to
direct
that
the
site
may
not
dispose
of
material
from
those
waste
streams
or
processes
at
the
WIPP
until
the
Agency's
findings
have
been
adequately
resolved.
We
believe
that
the
changes
will
result
in
equivalent
or
improved
oversight
of
waste
characterization
activities.

4­
12.
We
also
have
concerns
over
the
EPA's
proposed
tiering
system
for
baseline
approval;
mainly,
that
DOE
can
implement
changes
under
this
tiering
system
prior
to
reporting
these
changes
to
EPA.
This
is
analogous
to
DOE's
submittal
of
WIPP
Hazardous
Waste
Facility
Permit
Modification
Requests,
which
have
been
submitted
at
minor
class
levels,
only
to
be
rejected
and
require
re­
submittal
as
a
major
modification.
Given
this
history,
the
EPA
should
require
DOE
to
seek
a
preliminary
concurrence
for
tier
selection,
prior
to
formal
submittal.
The
approval
of
Tier
2
changes
could
be
a
less
cumbersome
process
than
those
of
Tier
1,
and
would
not
need
a
public
comment
process.
Also,
it
appears
that
Tier
2
changes
agreed
upon
between
the
EPA
and
the
DOE
may
never
be
publicly
disclosed.
The
EEG
suggests
that
a
notification
of
Tier
2
changes
be
made,
but
not
require
a
public
comment
period.
(
EEG)
16
Response
to
Comment
4­
12:
EPA
does
not
believe
that
the
proposed
tiering
system
is
analogous
to
DOE's
submittal
of
WIPP
Hazardous
Waste
Permit
Modification
Requests.
For
example,
when
submitting
a
WIPP
permit
modification
to
the
State
of
New
Mexico
(
i.
e.,
NMED)
DOE
interprets
NMED's
classification
levels
for
permit
modification.
Sometimes
NMED
has
rejected
class
designations
as
construed
by
DOE.
Under
today's
rule,
EPA's
baseline
approval
will
specify
any
limitations
on
the
approval.
It
will
also
specify
what
subsequent
WC
program
changes
or
expansion
must
undergo
further
EPA
inspection
or
approval
under
§
194.24
by
assigning
tiering
designations
to
these
activities.
EPA
will
assign
the
tiering
designations.
This
eliminates
the
possibility
of
misinterpretation
on
DOE's
part
and
the
possibility
of
EPA
not
agreeing
with
DOE's
selection
of
a
tier.
In
addition,
the
public
will
have
the
opportunity
to
comment
on
which
activities
should
be
assigned
to
each
tier.

EPA
would
like
to
further
clarify
the
details
of
the
tiers.
Tier
1
waste
characterization
activities
at
a
site
will
have
more
stringent
reporting
requirements.
These
activities
will
require
notification
by
DOE
and
approval
by
EPA
prior
to
shipment
of
waste
to
the
WIPP.
We
expect
to
conduct
site
inspections
as
part
of
our
decision­
making
process
for
many
Tier
1
activities.
Tier
2
activities
will
have
more
moderate
reporting
requirements
and
EPA
may
approve
changes
to
certain
activities
without
a
follow­
up
inspection
(
i.
e.,
desktop
review
and
approval
of
certain
technical
documents).
These
activities
will
require
a
notification
by
DOE
to
EPA
on
the
specific
changes;
however,
waste
can
be
shipped
to
the
WIPP
without
prior
Agency
approval.
For
Tier
2
notifications,
EPA
will
review
the
documentation
provided
by
DOE
and
reply
only
if
additional
information
or
analysis
is
needed.
Other
changes
(
i.
e.,
if
no
tier
is
specified)
will
be
captured
in
DOE's
annual
change
reports
or
continuing
compliance
inspections
under
§
194.24.

DOE
will
report
any
changes
in
equipment,
processes,
or
personnel,
based
on
their
tier
level,
and
certain
changes
must
be
reported
to
EPA
before
the
sites
are
allowed
to
ship
waste
using
the
waste
characterization
activities
in
question.
EPA
will
then
decide
whether
or
not
a
follow­
up
inspection
is
necessary
to
confirm
and
verify
the
adequacy
of
any
changes
to
the
site's
waste
characterization
program.
EPA
may
also
conduct
unannounced
site
inspections
of
a
tiered
activity
if
EPA
determines
a
need
based
on
the
available
information.
Below
are
examples
of
how
the
tiers
may
be
assigned:

°
In
its
baseline
inspection
by
EPA,
a
site
("
Site
1"
in
this
example)
demonstrates
that
it
can
quantify
10
WIPP­
tracked
radionuclides
only
in
homogeneous
organic
solids
using
a
particular
piece
of
radioassay
equipment
("
Equipment
A"
in
this
example).
The
baseline
approval
for
Site
1
is
issued
and
the
non­
destructive
assay
(
NDA)
equipment
is
approved
with
the
limitation
that
it
may
be
used
to
characterize
only
homogeneous
solids.
As
part
of
the
baseline
approval,
the
change
to
use
Equipment
A
on
a
new
waste
stream
is
designated
a
Tier
1
change.
Therefore,
if
Site
1
would
like
to
use
Equipment
A
to
characterize
inorganic
sludge
then
an
additional
EPA
approval
will
be
necessary.

°
Site
1
would
now
like
to
use
a
different
piece
of
equipment
("
Equipment
B"
in
this
example)
to
characterize
the
same
waste
stream
that
they
are
already
approved
for
(
in
this
17
case,
homogeneous
solids).
Equipment
B
is
nearly
identical
to
Equipment
A
in
specifications
and
operating
controls.
As
part
of
the
baseline
approval,
EPA
specifies
that
using
equivalent
equipment
to
characterize
an
approved
waste
stream
is
a
Tier
2
change.
Therefore,
Site
1
notifies
EPA
of
its
plans,
provides
documentation
to
EPA
that
Equipment
A
and
B
are
equivalent,
and
can
install
and
operate
the
new
equipment
without
prior
approval
by
the
Agency.

For
both
Tier
1
and
2
changes,
DOE
must
submit
to
EPA
information
discussing
the
relevant
program
changes
for
our
evaluation.
Prior
to
approval,
Tier
1
changes
may
require
an
inspection
to
obtain
objective
evidence
demonstrating
a
site's
WC
program
adequacy
and
WC
data
showing
compliance
with
the
WIPP
compliance
criteria
at
40
CFR
194.
EPA
will
docket
and
post
information
from
these
§
194.24
inspections
on
the
WIPP
website
for
public
review.
Generally,
Tier
2
changes
would
not
require
inspections,
provided
that
EPA
is
satisfied
with
the
information
submitted
by
DOE
regarding
the
changes.
EPA's
approval
letter
discussing
Tier
1
or
Tier
2
changes
would
explain
how
the
available
information
was
sufficient
to
justify
a
decision,
or
what
additional
information
was
collected
during
an
inspection,
if
one
was
conducted.
Also,
EPA
will
docket
and
post
on
the
WIPP
website
the
Tier
2
approval
letter
and
DOE
submission
for
public
review.

Once
the
Baseline
Compliance
Decision
has
been
made
and
tiers
have
been
assigned
at
the
sites,
the
EPA
may
decide
to
revise
the
tiering
designations,
based
on
a
variety
of
factors.
Some
sites
may
have
a
harder
time
converting
to
the
more
robust
inspections
regime,
and
certain
aspects
of
their
WC
program
that
were
strong
in
the
past
may
need
more
intense
scrutiny.
Conversely,
certain
sites
will
undoubtedly
improve
their
overall
performance
as
they
become
accustomed
to
the
new
system,
and
certain
aspects
of
their
WC
program
will
subsequently
require
less
attention.
The
decision
to
revise
tiers
at
a
site
will
be
made
through
continued
compliance
inspections
under
the
authority
of
§
194.24(
h),
as
previously
discussed.
The
Agency
will
announce
the
proposed
tier
changes
and
the
reasoning
behind
them
in
the
site's
inspection
report,
which
will
be
posted
on
the
WIPP
website
and
docketed
in
accordance
with
§
194.67.
If
the
tier
change
is
an
elevation
in
stringency
from
Tier
2
to
Tier
1
(
i.
e.,
additional
DOE
reporting
requirements
for
that
particular
waste
characterization
component
or
activity),
the
change
will
be
effective
immediately
and
the
site
will
be
expected
to
operate
under
the
more
stringent
requirements
without
delay.
If,
however,
the
change
is
a
"
downgrade"
in
stringency
from
Tier
1
to
Tier
2,
the
inspection
report
will
solicit
comments
from
the
public,
for
a
minimum
of
30
days,
to
let
them
raise
any
concerns
they
might
have.
The
site
will
continue
to
operate
under
the
more
stringent
tier
designation
until
public
comment
can
be
considered.

4­
13.
EPA's
proposed
change
to
allow
the
Central
Characterization
Project
(
CCP)
to
be
approved
once
for
all
waste
streams
is
equally
unacceptable.
This
opens
the
door
for
a
number
of
issues
that
parallel
the
problems
that
occurred
with
INEEL
in
July
2001.
(
NWNM,
CARD)

Response
to
Comment
4­
13:
EPA
does
not
approve
DOE's
CCP
activity
at
only
one
site
such
18
that
CCP's
waste
characterization
staff
can
go
to
other
DOE
sites
to
characterize
TRU
waste.
To
date,
EPA
has
inspected
and
approved
CCP
WC
activities
at
each
of
the
three
sites
where
it
is
currently
being
used
and
approved
only
one
waste
stream
at
each
(
TRU
debris
waste)
for
the
disposal
at
WIPP.
As
stated
in
the
preamble
to
the
proposed
rule,
under
the
new
provisions,
EPA
approval
under
§
194.8(
b)
will
still
be
required
for
CCP
operations
at
each
site
(
67
FR
51937/
3).
However,
to
clarify
our
intent,
we
emphasize
that
once
we
have
evaluated
the
CCP
at
a
site,
we
will
determine
whether
the
CCP
may
be
approved
to
characterize
all
waste
streams
at
that
site
only.
Under
the
new
provisions,
EPA
may
impose
waste
stream
or
other
limitations
on
its
approval
when
appropriate.

4­
14.
EPA
should
also
take
into
account
the
events
at
the
Savannah
River
Site
(
SRS).
The
EPA
approved
an
SRS
program
for
characterization
of
a
single
debris
waste
stream
in
April
2001.
The
December
2002
audit
was
intended
by
the
DOE
to
expand
this
approval
to
other
debris
waste
streams;
however,
the
EPA's
inspection
report
found
that
"
During
the
inspection,
EPA
determined
that
SRS
did
not
demonstrate
that
the
characterization
systems
inspected
were
adequate
to
be
extended
to
all
retrievably
stored,
contact­
handled
debris
waste."
Thus,
the
requirements
for
baseline
inspections
should
ensure
that
there
is
some
surety
that
additional
waste
streams
to
those
actually
audited
will
be
able
to
be
characterized
in
a
way
that
maintains
the
quality
of
characterization
established
by
the
baseline
inspection.
(
EEG)

Response
to
Comment
4­
14:
The
information
from
the
SRS
inspection
cited
by
the
commenter
is
accurate.
The
baseline
approval
and
tiering
process
that
the
Agency
is
finalizing
today
would
establish
whether
a
site
can
adequately
characterize
additional
waste
streams
with
physical
and
radiological
characteristics
similar
to
those
for
an
approved
waste
stream.
For
example,
to
minimize
the
likelihood
that
a
site
might
interpret
the
EPA
approval
of
an
individual
waste
stream
to
apply
to
other
wastes
belonging
to
the
same
waste
summary
category
group,
EPA
inspectors
will
evaluate
objective
evidence
obtained
at
the
site
and
specify,
through
tiering
designations,
whether
the
application
of
approved
WC
techniques
to
other
waste
streams
would
require
additional
inspection
and
approval
by
EPA.
If
additional
approval
is
required,
once
a
site
collects
sufficient
data
to
demonstrate
its
ability
to
characterize
the
waste
in
question,
it
will
notify
EPA
and
submit
relevant
information.
EPA
will
review
information
and
may
perform
an
inspection
to
verify
the
site's
capability.
Only
after
making
the
adequacy
determination
will
EPA
approve
waste
for
disposal
at
WIPP.
As
always,
if
a
problem
is
discovered,
EPA
retains
its
discretion
to
conduct
additional
inspections
or
restrict
waste
shipments.

4­
15.
All
existing
sites
have
had
some
difficulty
in
fully
complying
with
EPA's
existing
requirements
(
INEEL
in
2001,
LANL
shipment
delays,
etc).
The
proposed
rule
does
not
describe
these
situations,
does
not
show
how
the
proposed
rule
will
make
improvements
to
EPA
inspection
procedures,
nor
how
the
public
participation
process
will
be
improved.
Thus,
EPA
has
not
provided
an
adequate
rationale
for
the
revised
procedures.
(
SRIC)

Response
to
Comment
4­
15:
EPA
referred
to
the
INEEL
2001
incident
in
the
Background
19
Information
Document
(
BID)
submitted
with
the
proposed
rule
on
August
9,
2002.
Briefly,
at
INEEL,
the
site
erroneously
concluded
that
a
new
WC
system
that
was
put
to
use
for
a
period
of
time
was
similar
to
the
one
approved
by
EPA.
INEEL's
QA
organization
noted
this
mistake
and
informed
the
DOE
QA
organization
and
EPA
in
turn.
EPA
immediately
ordered
INEEL
to
suspend
all
TRU
waste
characterization
activities
at
the
site,
stopped
the
waste
truckload
en
route
to
WIPP
for
disposal,
and
asked
that
WIPP
not
process
INEEL
TRU
waste
containers
for
placement
in
the
repository.
EPA
inspected
INEEL's
new
WC
system
to
determine
whether
INEEL
was
characterizing
the
TRU
debris
waste
appropriately
and
TRU
waste
containers
analyzed
using
the
new
system
complied
with
the
radioactivity
limits.
Under
today's
rule,
we
will
assign
tiering
designations
to
different
WC
processes
and
equipment
at
each
site.
Major
WC
processes
and
equipment
(
such
as
radioassay
systems)
will
be
assigned
Tier
1,
so
that
incidents
like
INEEL
(
2001)
are
avoided.

As
discussed
in
the
proposed
rule
(
67
FR
51930),
the
Agency
aims
to
improve
public
participation
by
providing
an
opportunity
to
comment
on
EPA
inspection
reports
and
proposed
approval
decision
in
addition
to
DOE
program
documents
and
other
information.
Thus,
the
public
would
be
well
informed
about
the
inspection
that
was
performed,
which
decisions
are
proposed
and
why,
and
can
provide
comments
related
to
the
approval
and
tiering
process.

4­
16.
DOE
has
not
even
reached
much
of
the
very
old
waste
streams
that
may
be
more
difficult
to
characterize
adequately.
Problems
will
be
exacerbated
if
remote­
handled
(
RH)
waste
is
added
in
for
characterization.
There
are
too
many
unknowns
involved
with
future
and
possibly
older
waste
streams
to
allow
blanket
approval
for
a
program
and
processes
that
are
in
place
now.
(
CARD)

Response
to
Comment
4­
16:
EPA
agrees
that
DOE
has
not
begun
characterizing
many
of
the
older
or
more
complex
waste
streams,
including
RH
waste,
that
could
pose
particular
technical
challenges.
Under
the
inspection
process
we
are
finalizing
today,
DOE
sites
will
still
have
to
demonstrate
and
obtain
EPA
approval
of
their
ability
to
characterize
"
difficult­
to­
characterize"
TRU
wastes.
EPA
can
specify
limitations
on
the
baseline
compliance
approval
for
a
site.
Limitations
may
relate
to
waste
streams,
waste
categories,
processes,
or
other
factors
deemed
important
by
EPA.
Limitations
on
the
initial
§
194.8
approval
will
specify
what
WC
program
changes
or
expansion
must
undergo
further
EPA
inspection
or
approval
under
§
194.24
by
assigning
tiering
designations
to
these
activities.
Limitations
on
waste
stream
approvals
are
likely
to
be
meaningful
in
relation
to
especially
complex
or
unique
waste
streams
or
when
limited
acceptable
knowledge
is
not
available.
Expansion
of
the
WC
program
beyond
the
limitations
would
be
subject
to
the
assigned
tiering
designations
(
which
would
be
open
to
public
comment
at
the
time
of
the
Baseline
Compliance
Decision).
Given
the
complexities
of
RH
waste
characterization
and
the
fact
that
innovative
techniques
must
be
tailored
to
assess
these
specialized
waste
streams,
we
would
expect
that
any
program
expansion
to
RH
waste
would
be
designated
a
Tier
1
activity
requiring
advance
notification
and
approval
by
EPA
and
would
include
an
on­
site
inspection
(
unless
the
site
could
demonstrate
adequacy
for
the
particular
RH
waste
stream
at
the
time
of
the
Baseline
Compliance
Decision).
20
4­
17.
Public
involvement
in
the
approval
of
waste
characterization
programs
has
been
inadequate.
One
significant
source
of
the
problem
is
related
to
the
fact
the
EPA
issued
40
CFR
194.8
as
part
of
the
WIPP
Certification
Decision
on
May
18,
1998,
so
there
was
no
opportunity
for
public
comment
on
a
proposed
provision.
(
SRIC)

4­
18.
We
acknowledge
that,
for
several
reasons,
very
few
people
or
groups
actually
comment
now
on
EPA
inspections.
Members
of
the
public
do
not
see
the
notices
that
announce
these
inspections.
Perhaps
notice
could
be
given,
at
least
here
in
New
Mexico
and
around
the
involved
sites
in
other
ways
such
as
newspaper
ads
(
not
just
legal
notices)
and
radio
announcements,
and
EPA
could
seek
to
expand
a
list
of
interested
people
and
groups
who
would
be
informed
directly.
(
CARD)

Response
to
Comments
4­
17
and
4­
18:
EPA
fully
discussed
both
the
reasons
for
requiring
sitespecific
waste
characterization
determinations
and
a
proposed
mechanism
for
carrying
out
these
requirements.
See
the
proposed
WIPP
Certification
at
CFR
58814/
2
­
58815/
1.

Over
the
past
4
years,
EPA
has
made
every
effort
to
inform
public
of
EPA
inspections
when
necessary
by
issuing
a
Federal
Register
notice
and
posting
updates
on
the
EPA's
WIPP
website.
DOE
documents
and
other
material
related
to
these
inspections
has
also
been
docketed
at
each
of
our
docket
locations.
However,
we
recognize
that
the
highly
technical
nature
of
the
documents
available
for
comment
may
have
discouraged
public
participation.
In
recognition
of
this,
the
changes
to
the
site
approval
process
include
significant
changes
to
the
public
comment
process.
The
changes
allow
for
comment
not
only
on
DOE's
technical
documents,
but
also
on
EPA's
proposed
decision
on
site
approval.
The
public
will
also
be
able
to
comment
directly
on
the
proposed
tiering
designations
(
and
associated
level
of
EPA
review
and
approval)
for
subsequent
changes
or
expansions
of
the
WC
program
at
a
given
site.
A
minimum
45­
day
comment
period
will
be
opened
for
the
proposed
Baseline
Compliance
Decisions
at
each
site.

EPA
acknowledges
that
the
Federal
Register
is
not
the
only
effective
tool
for
providing
information
to
the
public.
Under
these
revisions,
EPA
will
issue
a
Federal
Register
notice
for
the
initial
Baseline
Compliance
Decision
at
each
site.
EPA
also
expects
to
use
e­
mail,
web
updates,
and
other
more
user­
friendly
communication
tools
to
notify
stakeholders
of
the
occurrence
and
results
of
baseline
approvals
and
subsequent
ongoing
inspections.

4­
19.
EPA's
justification
that
the
existing
requirement
should
be
changed
because
DOE's
program
"
will
overwhelm
our
resources."
is
not
appropriate.
The
changes
should
be
justified
on
a
technical
basis.
(
EEG,
SRIC,
CARD)

Response
to
Comment
4­
19:
We
believe
that
the
proposed
changes
are
fully
justifiable
on
a
technical
basis.
While
resource
consideration
is
a
valid
factor,
the
discussion
of
resources
in
the
preamble
to
the
proposal
may
have
been
misleading
in
regard
to
its
relative
importance.
The
revised
process
provides
equivalent
or
improved
oversight,
more
control
over
schedule,
better
21
prioritization
of
technical
issues
and
distinctions,
and
flexibility
to
address
relative
levels
of
experience
or
expertise
at
various
DOE
sites.
(
See
also
comments
4­
10,
4­
12,
4­
13.)

4­
20.
The
reference
in
the
proposed
Section
194.8(
b)(
3)(
i)
to
Section
194.4(
b)(
1)
and
(
2)
could
change
the
relationship
between
the
processes
of
certification
and
recertification
of
the
WIPP
and
the
processes
of
determining
baseline
and
continued
compliance
of
waste
generator
sites.
The
provisions
of
Section
194.4
are
specific
to
the
WIPP
certification
and
are
not
appropriate
responses
to
noncompliance
at
a
waste
generator
site.

The
reference
to
Section
194.4
should
be
removed.
The
new
rule
should
contain
its
own
discussion
of
suspension,
modification,
and
revocation
of
a
waste
site's
Baseline
Compliance
Decision,
because
the
provisions
of
Section
194.4
are
specific
to
responses
to
noncompliance
at
a
WIPP
site.

The
provisions
dealing
with
waste
generator
sites
should
explicitly
state
that
the
EPA's
decisions
regarding
waste
generator
sites
have
no
bearing
on
WIPP
certification
or
recertification.
Inspections
of
waste
generator
sites
and
the
subsequent
findings
are
irrelevant
to
the
long­
term
performance
of
the
WIPP
repository.
Suspending,
revoking,
or
modifying
the
WIPP
Certification
due
to
problems
at
a
waste
generator
site
would
be
arbitrary
and
capricious
because
the
EPA
has
neither
explained
how
nor
justified
why
noncompliance
at
a
waste
generator
site
could
invalidate
the
certified
performance
of
the
WIPP.
(
JHA)

4­
21.
The
language
in
Section
194.8(
b)(
3)
suggests
that
Section
194.4(
b)
be
utilized
as
a
mechanism
for
determining
whether
or
not
waste
generator
sites
are
in
compliance,
and
what
actions
to
take
if
they
are
not.
The
proposed
language
seems
to
indicate
that
EPA
could
jeopardize
the
WIPP
facility
certification.
If
a
single
generator
site
is
problematic,
all
the
other
generator
sites
should
not
have
to
pay
a
penalty
because
one
facility
is
not
in
compliance.
EPA
has
neither
explained
how
nor
justified
why
noncompliance
at
a
single
site
could
invalidate
the
certified
performance
of
the
WIPP.
(
WTS)

4­
22.
We
strongly
disagree
with
the
oral
testimony
provided
on
behalf
of
John
Hart
Associates
and
Westinghouse
TRU
Solutions
at
the
September
24­
25
hearings
regarding
proposed
40
CFR
Part
194.8(
b)(
3)(
i).
Those
contractors
expressed
concerns
that
waste
characterization
programs
and
processes
that
are
not
adequately
implemented
at
a
generator
site
could
result
in
modification,
suspension,
or
revocation
of
the
WIPP
Certification
under
40
CFR
194.4(
b)(
1)
and
(
2).
Those
contractors
do
not
believe
that
it
is
appropriate
to
tie
certification
requirements
for
WIPP
disposal
with
waste
characterization
problems
at
individual
sites.
EPA
should
be
clearly
authorized
to
not
only
suspend
shipments
from
the
generator
sites,
as
provided
in
the
proposed
rule,
but
to
also
take
action
regarding
the
WIPP
Certification,
including
suspending
operations
at
WIPP.
Thus,
we
support
the
proposed
40
CFR
194.8(
3)(
i)
and
encourage
EPA
to
preserve
it
in
the
final
rule
and
to
not
modify
or
remove
it
as
was
suggested
by
the
two
contractors'
oral
22
comments.
(
SRIC)

Response
to
Comments
4­
20
through
4­
22:
Proposed
section
194.8(
b)(
4)(
i)
provides
that
EPA
may
suspend
shipments
of
TRU
waste
from
an
approved
TRU
waste
site
if
EPA
subsequently
determines
that
waste
characterization
programs
or
processes
are
not
adequately
established
or
implemented.
In
addition,
if
necessary,
EPA
may
take
action
under
section
194.4(
b)(
1)
or
(
2).
Section
194.4(
b)(
1)
provides
that
EPA
may
suspend,
modify,
or
revoke
the
certification
of
the
WIPP.
Suspension
may
be
at
the
discretion
of
EPA;
modification
or
revocation
will
be
conducted
by
rule
pursuant
to
5
U.
S.
C.
§
553.
Section
194.(
b)(
3)(
i)
provides
that
EPA
may
request
that
DOE
provide
information
to
enable
EPA
to
determine
whether
suspension,
modification,
or
revocation
of
the
certification
is
warranted.
DOE's
inability
to
properly
establish,
maintain,
or
implement
adequate
waste
characterization
activities
at
a
waste
generator
site
could
lead
to
circumstances
that
necessitate
consideration
of
suspension,
modification,
or
revocation
of
the
WIPP
certification.
Poorly
and/
or
inadequately
characterized
waste
when
emplaced
in
the
repository
could
be
relevant
to
determining
the
long­
term
performance
of
the
WIPP.
Therefore,
EPA
disagrees
that
the
provisions
of
section
194.4(
b)
are
"
specific"
only
to
the
WIPP
facility,
and
can
never
be
relevant
to
activities
at
a
waste
generator
site.

4­
23.
If
EPA
is
going
to
revisit
all
of
the
waste
generator
sites
(
including
those
alreadyapproved
does
that
imply
that
EPA
hasn't
been
doing
their
job
when
they
authorized
the
sites
to
begin
shipment?
Doesn't
this
mean
you're
putting
these
sites
in
a
position
of
essentially
having
to
start
all
over
again?
The
rationale
for
this
is
not
clear.
This
could
imply
that
the
initial
authorizations
up
to
this
point
were
not
particularly
well
done
in
the
first
place,
which
I'm
sure
is
not
the
case.
Is
there
some
intermediate
step
that
could
be
done
for
sites
where
EPA
has
already
authorized
shipment?
(
RW)

Response
to
Comment
4­
23:
The
purpose
of
this
re­
visiting/
re­
approving
of
already
approved
sites
(
LANL,
RFETS,
INEEL,
Hanford,
and
SRS)
is
to
provide
an
opportunity
both
to
seek
further
information
in
support
of
our
tiering
decision
and
to
allow
for
public
comment
on
our
proposed
tiering
designations
for
those
sites.
While
we
have
a
great
deal
of
experience
at
those
sites,
we
will
nevertheless
be
performing
a
baseline
§
194.8
inspection
to
gather
additional
information
to
inform
our
tiering
assignment
decision.
Sites
that
have
already
been
approved
can
continue
to
ship
waste
until
and
while
the
new
Baseline
Compliance
Decisions
is
being
made.
We
expect
the
baseline
decision
would
incorporate
previously
approved
waste
streams
and
WC
processes,
provided
the
baseline
inspections
show
they
continue
to
be
adequately
executed.

4­
24.
Public
safety
is
not
the
major
concern
of
the
EPA
regarding
WIPP.
EPA
really
needs
to
get
"
tough"
with
DOE
and
tell
them
they
need
to
inform
everyone
openly
of
what
is
really
going
on
in
their
waste
characterization
activities,
and
that
EPA
should
not
be
making
regulations
more
"
flexible"
as
the
proposed
changes
claim.
(
RL)

Response
to
Comment
4­
24:
In
the
preamble
of
this
final
rule,
EPA
has
described
aspects
of
this
rule
as
"
flexible."
EPA
does
not
imply
that
this
change
will
diminish
in
any
way
the
level
or
23
efficacy
of
our
congressionally
mandated
oversight
of
the
DOE
waste
characterization
programs
at
sites.
Instead,
it
is
a
recognition
by
experienced
EPA
inspectors
of
the
differences
in
waste
characterization
processes
at
each
site
and
the
need
to
have
the
flexibility
to
inspect
each
site
effectively.
EPA
is
committed
(
both
in
the
past
and
as
a
result
of
this
rule)
to
oversight
of
the
items
and
activities
that
are
important
to
the
containment
of
TRU
waste
at
the
WIPP
and
the
protection
of
public
health
and
the
environment.

ISSUE
#
5:
SECTIONS
194.12
AND
194.13
 
SUBMISSION
OF
COMPLIANCE
APPLICATIONS
AND
REFERENCE
MATERIALS
5­
1.
We
endorse
the
reduction
in
the
number
of
copies
of
compliance
applications
and
reference
materials
as
proposed
in
the
changes
to
Section
194.12
and
Section
194.13.
This
change
will
reduce
costs
and
improve
the
efficiency
of
these
activities.
(
DOE)

5­
2.
We
agree
that
the
reduction
of
paper
copies
is
beneficial,
especially
when
electronic
copies
are
more
easily
disseminated.
However,
the
EPA
needs
to
specify
where
the
five
paper
copies
are
destined
to
ensure
proper
availability
to
all
concerned
parties.
(
EEG)

5­
3.
We
do
not
oppose
the
reduction
in
the
number
of
paper
copies
of
compliance
applications
and
reference
materials
so
long
as
each
of
the
New
Mexico
dockets
receives
a
paper
copies
of
these
materials
and
ready
access
to
an
alternative
format.
EPA
should
state
that
the
intent
is
to
provide
paper
copies
to
each
New
Mexico
docket.
The
rule
should
require
DOE
to
make
copies
of
compliance
applications
and
reference
materials
widely
available
to
the
public
in
either
written
or
electronic
form.
(
SRIC,
CCNS)

5­
4.
Although
digital
formats
and
the
internet
can
make
access
to
and
commenting
on
compliance
applications
and
other
documents
much
easier
for
some,
many
people
still
have
not
fully
made
the
change
from
print
to
digital
media,
especially
minority
members
of
the
public.
With
ten
required
copies
of
applications
and
reference
materials,
there
is
at
least
more
access
to
these
documents
even
though
ten
might
actually
not
be
enough.
CARD
would
hope
that
there
would
be
copies
available
in
at
least
Santa
Fe
and
Albuquerque,
New
Mexico.
Has
EPA
received
requests
from
other
states
or
localities
for
hard
copies
of
materials?
Limiting
the
public's
access
to
printed
media
to
only
four
public
dockets
seems
extremely
restrictive
and
almost
guaranteed
to
lessen
public
participation.
(
CARD)

Response
to
Comments
5­
1
through
5­
4:
EPA
believes
that
taking
advantage
of
electronic
and
digital
media
can
improve
public
access
and
facilitate
public
review
of
information,
as
well
as
being
cost
effective
and
environmentally
responsible.
However,
the
Agency
acknowledges
that
there
is
not
universal
availability
or
understanding
of
computers.
Furthermore,
EPA
is
committed
to
maintaining
the
public
dockets
in
New
Mexico,
as
described
in
the
WIPP
Compliance
Criteria
at
§
194.67.
Thus,
EPA's
documentation
and
outreach
include
both
paper
and
electronic
media
24
(
documents
will
be
available
online
as
well
as
in
hard
copy
form).
In
the
final
rule,
EPA
will
specify
that
the
five
paper
copies
are
intended
for
the
official
docket
in
Washington,
DC,
and
for
the
information
dockets
in
New
Mexico.
The
Agency
has
not
received
many
requests
from
other
states
or
localities
for
hard
copies
of
documents;
however,
EPA
has
always
sent
materials
to
interested
parties
upon
request.

5­
5.
We
are
in
favor
of
the
proposed
changes
outlined
in
Sections
194.12
and
194.13.
We
recommend,
however,
that
the
exact
number
and
specification
of
applications
and
reference
materials
be
left
open
for
negotiation
between
DOE
and
EPA
and
not
specified
in
the
regulations
or
as
an
alternative
specified
in
guidance
documentation.
(
WTS)

Response
to
Comment
5­
5:
EPA
is
requiring
DOE
to
submit
five
paper
copies
of
the
recertification
application
and
related
materials.
These
copies
will
be
placed
in
the
public
dockets
to
meet
our
obligations
to
outlined
in
§
194.67.
Documents
will
also
be
obtainable
electronically,
as
well
as
available
upon
request.
EPA
and
DOE
may
also
negotiate
submission
of
additional
copies
of
these
materials
as
needed.

ISSUE
#
6:
SECTIONS
194.2
AND
194.24
 
DEFINING
"
ACCEPTABLE
KNOWLEDGE"
AND
REPLACING
"
PROCESS
KNOWLEDGE"
WITH
THE
NEW
AK
DEFINITION
6­
1.
We
endorse
the
use
of
"
acceptable
knowledge"
in
place
of
"
process
knowledge"
as
proposed
in
the
change
to
Section
194.24(
c)(
3).
(
DOE,
RW)

6­
2.
We
support
the
EPA's
decision
to
replace
the
term
"
process
knowledge"
with
the
term
"
acceptable
knowledge."
We
note
that
the
definition
of
"
process
knowledge"
as
described
left
great
latitude
in
applying
the
definition.
(
EEG)

6­
3.
We
do
not
object
to
the
change
from
"
process
knowledge"
to
"
acceptable
knowledge,"
nor
to
the
definition
of
the
latter
term.
(
SRIC,
CCNS,
CARD)

Response
to
Comments
6­
1
through
6­
3:
§
194.2
will
now
define
"
acceptable
knowledge"
as
"...
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:
25
LIST
OF
COMMENTERS
Public
Hearings
on
the
proposed
alternative
provisions
to
40
CFR
194
were
conducted
in
two
New
Mexico
sites.
The
dates
of
the
proceedings
were
as
follows:
Albuquerque,
September
24,
2002;
Sante
Fe,
September
25,
2002.
The
following
is
a
list
of
those
individuals
who
testified
including
their
place
of
residence,
title
and
affiliation,
if
applicable.
An
asterisk
(*)
is
used
to
denote
that
the
individual
submitted
written
documentation
to
complement
his/
her
oral
testimony.

Albuquerque
Hearing
Comment
ID
Name
JHA
*
Sharla
Bertram,
Contractor,
John
Hart
&
Associates
SRIC
*
Don
Hancock,
Southwest
Research
and
Information
Center
RW
Ruth
Weiner
Santa
Fe
Hearing
Comment
ID
Name
CCNS
*
Joni
Arends,
Concerned
Citizens
for
Nuclear
Safety
CARD
*
Deborah
Reade,
Citizens
for
Alternatives
to
Radioactive
Dumping
WTS
*
Steve
Casey,
Westinghouse
TRU
Solutions
RL
Rick
Lass,
Green
Party
(
New
Mexico
State
Representative)

Electronic
(
using
the
EPA's
EDOCKET
system)
comments
on
the
proposed
rule
were
submitted
to
EDOCKET
#
OAR­
2002­
0005.
The
following
is
a
list
of
commentors
and
where
appropriate,
the
organizations
they
represent.

EDOCKET
Comments
Comment
ID
Name
ANON1
Anonymous
Commenter
ANON2
Anonymous
Commenter
SM
SPECMAT
Written
comments
received
through
e­
mail
or
regular
mail
on
the
proposed
rule
were
submitted
to
EPA's
Air
Docket
(
Attn:
EDOCKET
#
OAR­
2002­
0005
or
A­
98­
49).
The
following
is
a
list
of
commentors,
state
of
residence
(
if
known),
and
where
appropriate,
the
organizations
they
represent.
26
Mailed
Comments
Comment
ID
Name
DOE
Patrice
M.
Bubar,
Associate
Deputy
Assistant
for
Integration
and
Disposition,
Office
of
Environmental
Management,
Department
of
Energy
EEG
Matthew
K.
Silva,
Director,
Environmental
Evaluation
Group
SRIC
Don
Hancock,
Southwest
Research
and
Information
Center
CCNS
Joni
Arends,
Concerned
Citizens
for
Nuclear
Safety
NWNM
Geoff
Petrie,
Nuclear
Watch
of
New
Mexico
CARD
Deborah
Reade,
Research
Director,
Citizens
for
Alternatives
to
Radioactive
Dumping
APPENDIX
B:
27
LIST
OF
ACRONYMS
AK
­
Acceptable
knowledge
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
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
PK
­
Process
knowledge
QA
­
Quality
assurance
RC
­
Radiochemistry
RCRA
­
Resource
Conservation
Recovery
Act
RFETS
­
Rocky
Flats
Environmental
Technology
Site
RTR
­
Real­
time
radiography
SRS
­
Savannah
River
Site
TRU
­
Transuranic
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
