Response
to
Comments
on
the
OMP
XL
Project
NPRM
June
27,
2005
2
Index
of
Commenters
1.
OMPP­
00001
Leslie
Burris,
Retired
Division
Director
(
Argonne
National
Laboratory),
Private
Citizen,
Naperville,
Illinois
2.
OMPP­
00002
Richard
Grondin,
Vice
President,
Mixed
Waste
Operations,
ATG,
Inc.,
Richland,
Washington
3.
OMPP­
00003
Paul
C.
Childress,
Vice
President,
Eurotech,
Fairfax,
Virginia
4.
OMPP­
00004
Shimoga
R.
Prakash,
Ph.
D.,
Director,
Isotope
Chemistry,
DuPont
Pharmaceuticals
Company,
Newark,
Delaware
5.
OMPP­
00005
Jerome
A.
Klun,
Research
Entomologist,
United
States
Department
of
Agriculture,
Beltsville,
Maryland
6.
OMPP­
00006
James
C.
Wiley,
Jr.,
Vice
President
and
Department
Manager,
ChemSyn
Laboratories,
Lenexa,
Kansas
7.
OMPP­
00007
Clint
Gregg,
Safety
and
Environmental
Compliance
Officer,
ChemSyn
Laboratories,
Lenexa,
Kansas
8.
OMPP­
00008
Eric
Boeldt,
CHP,
Radiation
Safety
Officer,
The
Pennsylvania
State
University,
University
Park,
Pennsylvania
9.
OMPP­
00009
William
V.
Lipton,
ScD,
CHP,
Private
Citizen,
Ann
Arbor,
Michigan
10.
OMPP­
00010
Alan
E.
Waltar,
Professor
and
Head,
Department
of
Nuclear
Engineering,
Texas
A&
M
University,
College
Station,
Texas
11.
OMPP­
00011
Scottie
Walker,
Health
Physicist,
Sandia
National
Laboratories,
no
address
given
12.
OMPP­
00012
W.
J.
Quapp,
PE,
Teton
Technologies,
Inc.,
Idaho
Falls,
Idaho
13.
OMPP­
00013
John
M.
Raymont,
Jr.,
President
and
CEO,
NUKEM
Nuclear
Technologies,
Columbia,
South
Carolina
14.
OMPP­
00014
William
R.
Sugnet,
Private
Citizen,
Granite
Bay,
California
15.
OMPP­
00015
Daniel
F.
Liberman,
Ph.
D.,
RSO,
Associate
Director,
Environmental
Affairs
and
Safety,
Boehringer
Ingelheim
Pharmaceuticals,
Inc.,
Ridgefield,
Connecticut
16.
OMPP­
00016
Robin
L.
Elliott,
Chair,
State
of
Delaware
Authority
on
Radiation
Protection,
Dover,
Delaware
17.
OMPP­
00017
Sheryl
J.
Loux,
Research
Biochemist,
Private
Citizen,
Kalamazoo,
Michigan
18.
OMPP­
00018
Jane
Poths,
Ph.
D.,
Nuclear
Chemist,
Private
Citizen,
Los
Alamos,
New
Mexico
19.
OMPP­
00019
Robert
Fazio,
Ph.
D.,
President,
ViTrax
Company,
Placentia,
California
20.
OMPP­
00020
Richard
S.
Thomason,
Ph.
D.,
Senior
Scientist,
Private
Citizen,
Aiken,
South
Carolina
21.
OMPP­
00021
Bachir
Latli,
Ph.
D.,
Boehringer
Ingelheim
Pharmaceuticals,
Inc.,
Ridgefield,
Connecticut
22.
OMPP­
00022
William
J.
Wheeler,
Ph.
D.,
Private
Citizen,
no
address
given
23.
OMPP­
00023
Mary
North­
Abbott,
Project
Manager,
Environmental
Containment
&
Control
Program,
MSE
Technology
Applications,
Inc.,
Butte,
Montana
3
24.
OMPP­
00024
M.
W.
Overhoff,
Ph.
D.,
President,
Overhoff
Technology
Corporation,
Milford,
Ohio
25.
OMPP­
00025
Michael
P.
Last,
Clerk,
The
Campus
Consortium
for
Environmental
Excellence,
Boston,
Massachusetts
26.
OMPP­
00026
Roy
G.
Post,
Professor
Emeritus,
University
of
Arizona,
Private
Citizen,
Tucson,
Arizona
27.
OMPP­
00027
Bill
Weaver,
Private
Citizen,
Hummelstown,
Pennsylvania
28.
OMPP­
00028
James
W.
Davis,
Director
Operations
Nuclear
Generation
Division,
Nuclear
Energy
Institute,
Washington,
DC
29.
OMPP­
00029
Andy
Lawrence,
Director,
Office
of
Environmental
Policy
and
Guidance,
United
States
Department
of
Energy,
Washington,
DC
30.
OMPP­
00030
Kenneth
L.
Miller,
Chairman
of
the
Board,
Norman
W.
Henry,
III,
TRAC
Chair,
and
John
R.
Vincenti,
Executive
Secretary,
The
American
Council
of
Users
of
Radioactive
Isotopes
(
ACURI)
Association,
University
Park,
Pennsylvania
31.
OMPP­
00031
Michael
Lemon,
Radiation
Safety
Officer,
Environmental
Health
and
Safety,
The
University
of
Kansas,
Lawrence,
Kansas
32.
OMPP­
00032
Wesley
R.
Van
Pelt,
Ph.
D.,
CIH,
CHP,
President,
Wesley
R.
Van
Pelt
Associates,
Incorporated,
Paramus,
New
Jersey
33.
OMPP­
00033
Joseph
M.
Melnic,
Private
Citizen,
Middletown,
Pennsylvania
34.
OMPP­
00034
Larry
W.
McNamara,
President,
Nuclear
Services,
Permafix
Environmental
Services,
Gainesville,
Florida
35.
OMPP­
00035
Cynthia
L.
Salisbury,
Vice
President,
Regulatory
Affairs,
Polytek
Development
Corp.,
Easton,
Pennsylvania
36.
OMPP­
00036
James.
M.
Phillips,
Office
of
General
Counsel,
The
University
of
Texas
System,
Austin,
Texas
37.
OMPP­
00037
J.
Richard
Heys,
Ph.
D.,
Chief
Financial
Officer,
International
Isotope
Society,
King
of
Prussia,
Pennsylvania
38.
OMPP­
00038
Hiroi
Morimoto,
Private
Citizen,
El
Cerrito,
California
39.
OMPP­
00039
Joseph
M.
Melnic,
Technical
Manager,
Lionville
Laboratory,
Inc.,
Lionville,
Pennsylvania
40.
OMPP­
00040
Janet
Griffin,
Manager,
Environmental
Affairs,
Schering­
Plough
Corporation,
Kenilworth,
New
Jersey
41.
OMPP­
00041
Cameron
Huff,
Private
Citizen,
no
address
given
42.
OMPP­
00042
Gail
Martin,
Private
Citizen,
no
address
given
43.
OMPP­
00043
Li­
Yang
Chang,
Ph.
D.,
Chemical/
Environmental
Engineer,
Environment,
Health
and
Safety
Division,
Lawrence
Berkeley
National
Laboratory,
no
address
given
44.
OMPP­
00044
Alice
E.
Till,
Ph.
D.,
Vice
President
Science
Policy
and
Technical
Affairs,
Pharmaceutical
Research
and
Manufacturers
of
America,
Washington,
DC
45.
OMPP­
00045
Craig
Barney,
Manager,
Environmental
Programs,
Stanford
University,
Stanford,
California
46.
OMPP­
00046
George
Bramblett,
Project
Manager,
Decontamination
and
4
Decommissioning,
Del
Mar,
California
47.
OMPP­
00047
Jeffry
A.
Siegel,
Ph.
D.,
Chairperson,
American
College
of
Nuclear
Physicians/
Society
of
Nuclear
Medicine
Joint
Government
Relations
Committee,
Reston,
Virginia
48.
OMPP­
00048
Carl
E.
Walter,
Professional
Nuclear
Engineer,
State
of
California,
no
address
given
49.
OMPP­
00049
Vincent
D.
Chase,
M.
S.,
CHP,
President,
New
Jersey
Chapter
of
the
Health
Physics
Society,
no
address
given
50.
OMPP­
00050
David
C.
McGraw,
Director,
Environment,
Health
and
Safety
Division,
Ernest
Orlando
Lawrence
Berkeley
National
Laboratory,
Berkeley
California
51.
OMPP­
00051
Philip
G.
Williams,
Ph.
D.,
Senior
Scientist
at
Lawrence
Berkeley
National
Laboratory,
Private
Citizen,
Oakland,
California
52.
OMPP­
00052
Richard
H.
Nolan,
Director,
Berkeley
Site
Office,
United
States
Department
of
Energy,
Lawrence
Berkeley
National
Laboratory,
Berkeley,
California
53.
OMPP­
00053
Steven
R.
Brehio,
Associate
Director,
EH&
S,
Northeastern
University,
Boston,
Massachusetts
54.
OMPP­
00054
Leonard
R.
Smith,
Chairperson,
Committee
on
Regulatory
and
Legislative
Issues,
Council
on
Radionuclides,
and
Radiopharmaceuticals
(
CORAR),
Inc.,
Moraga,
California
55.
OMPP­
00055
Dr.
R.
Tom
Walters,
Ph.
D.,
Walters,
Aiken,
South
Carolina
56.
OMPP­
00056
Marty
Scanlon,
PE,
CerOx
Corporation,
Sunnyvale,
California
57.
OMPP­
00057
Robert
E.
Peterson,
University
Radiation
Safety
Officer,
Office
of
Environmental
Health
and
Safety,
The
Ohio
State
University,
Columbus,
Ohio
58.
OMPP­
00058
Penny
S.
Amy,
Ph.
D.,
Professor
and
Director
Biotechnology
Programs,
Department
of
Biological
Sciences,
University
of
Nevada
Las
Vegas,
Las
Vegas,
Nevada
59.
OMPP­
00059
W.
W.
Bailey,
Duratek,
Inc.,
Columbia,
Maryland
60.
OMPP­
00060
David
W.
Reaney,
Manager
Treatment
Systems,
Retech
Systems
LLC,
Ukiah,
California
61.
OMPP­
00061
Robert
D.
Gallagher,
President,
NSSI/
Sources
&
Services,
Inc.,
Houston,
Texas
62.
OMPP­
00062
Joseph
Castronuovo,
MD,
Private
Citizen,
no
address
given
63.
OMPP­
00063
Carrie
Wager,
Ph.
D.,
Private
Citizen,
no
address
given
64.
OMPP­
00064
Vincent
D.
Chase,
M.
S.,
CHP,
President,
New
Jersey
Chapter
of
the
Health
Physics
Society,
no
address
given
 
identical
to
Comment
#
49
65.
OMPP­
00065
Edward
A.
Tupin,
M.
S.,
CHP,
Private
Citizen,
Atlanta,
Georgia
5
Because
many
of
the
specifics
comments
are
common
to
more
than
one
commenter,
the
Agency
is
responding
to
the
comments
by
repeating
the
comment,
listing
all
the
commenters
that
made
the
comment
in
bold
text
(
using
the
index
number
ascribed
to
the
commenters),
and
then
responding.
Supportive
comments
may
be
paraphrased,
but
adverse
comments
will
be
repeated
verbatim.

Comment:
Many
commenters
submitted
the
following
comment
either
verbatim
or
excerpted
and
condensed
specific
portions
of
it.

"[
We]
are
writing
to
offer
[
our]
strongest
support
for
the
innovative
Project
XL
application
described
by
the
U.
S.
Environmental
Protection
Agency
(
EPA)
in
the
above­
referenced
proposed
rule.

Pharmaceutical
mixed
waste
(
LLMW),
containing
small
quantities
of
tritium
or
carbon­
14,
represents
a
management
and
disposal
problem
vastly
out
of
proportion
with
the
chemical
or
radioactive
hazards
inherent
in
the
waste.
Dual
regulation
under
both
the
Nuclear
Regulatory
Commission
(
NRC)
and
EPA
has
resulted
in
a
high
regulatory
burden
for
generators,
and
difficulties
in
all
stages
of
waste
management
and
disposal.
There
are
very
few
treatment
and
disposal
options
available
for
mixed
waste,
and
is
some
cases
no
outlets
are
available
at
all.
When
available,
mixed
waste
treatment
and
disposal
is
economically
prohibitive
for
most
academic
and
biomedical
research
institutions,
with
costs
ranging
from
100'
s
to
1000'
s
times
as
much
as
equivalent
quantities
of
either
radioactive
or
hazardous
chemical
waste.
The
high
regulatory
burden
for
managing
and
disposing
of
the
waste,
complex
and
overlapping
regulations,
limited
and/
or
nonexistent
treatment
and
disposal
options
and
the
high
costs
associated
with
the
mixed
waste
issues
have
served
as
a
huge
disincentive
to
conducting
research
and
development
studies
which
rely
on
tritium
or
carbon­
14
labeled
chemicals.

In
this
rulemaking,
the
EPA
is
proposing
site­
specific
regulatory
relief
from
RCRA
so
that
the
organic
component
of
LLMW
may
be
destroyed
by
catalytic
oxidation,
and
the
radioactive
residues
(
tritiated
water
or
carbon
dioxide)
will
be
collected
and
disposed
as
LLRW).
This
is
a
simple
and
straightforward
solution.

"
In
this
specific
XL
pilot
project,
EPA
is
testing
its
belief
that,
in
certain
scenarios
(
e.
g.,
small
volumes
of
pharmaceutical
R&
D­
generated
LLMW
being
treated
by
a
bench­
scale
high
temperature
catalytic
oxidation
unit
in
an
NRC­
licensed
laboratory),
NRC
regulatory
oversight
provides
sufficient
safeguards
to
ensure
protection
of
human
health
an
the
environment
without
additional
RCRA
Subtitle
C
oversight."
[
Federal
Register,
Vol.
66,
No.
142,
24
July
2001,
p.
38401].

As
noted
in
the
proposed
rule,
the
project
is
made
all
the
more
sensible
by
considering
the
small
volumes
of
waste
involved,
the
small
scale
of
the
treatment
process,
treatment
on­
site
by
the
waste
generators,
the
sophisticated
level
of
expertise
of
the
staff
involved
in
the
treatment,
and
the
protective
controls
already
in
place
under
NRC
regulation
of
the
radioactive
materials
in
question.
1
CORAR
members
include
the
major
manufacturers
and
distributors
of
radio
pharmaceuticals,
radioactive
sources
and
research
radionuclides
used
in
the
U.
S.
for
therapeutic
and
diagnostic
medical
applications
and
for
industrial,
environmental
and
biomedical
research
and
quality
control.

6
In
addition
to
the
advantages
of
small
chemical
scale
and
local
application
of
the
process
by
highly
skilled
staff,
the
method
has
been
shown
to
achieve
organic
destruction
efficiencies
superior
to
those
required
of
large­
scale
commercial
processes
(
e.
g.,
incineration),
and
prevents
the
release
of
the
radioactive
treatment
residue
to
the
environment.
The
environmental
benefits
of
the
process
are
therefore
very
clear.

[
We]
urge
the
EPA
to
finalize
this
initiative
as
soon
as
possible.
Early
demonstration
of
the
efficacy
of
the
Ortho­
McNeil
Pharmaceutical,
Inc.
approach
will
hasten
the
nationwide
deployment
of
this
technology
and
the
EPA's
innovative
regulatory
solution
proposed
here.
Thank
you
for
the
opportunity
to
comment
on
this
proposed
rule.

Commenters:
OMPP­
00001,
OMPP­
00003,
OMPP­
00004,
OMPP­
00006,
OMPP­
00007,
OMPP­
00008,
OMPP­
00009,
OMPP­
00010,
OMPP­
00011,
OMPP­
00012,
OMPP­
00013,
OMPP­
00014,
OMPP­
00015,
OMPP­
00016,
OMPP­
000017,
OMPP­
00018,
OMPP­
00019,
OMPP­
00020,
OMPP­
00021,
OMPP­
00022,
OMPP­
00023,
OMPP­
00024,
OMPP­
00025,
OMPP­
00026,
OMPP­
00027,
OMPP­
00028,
OMPP­
00030,
OMPP­
00031,
OMPP­
00032,
OMPP­
00033,
OMPP­
00035,
OMPP­
00036,
OMPP­
00037,
OMPP­
00038,
OMPP­
00039,
OMPP­
00040,
OMPP­
00041,
OMPP­
00042,
OMPP­
00043,
OMPP­
00044,
OMPP­
00045,
OMPP­
00046,
OMPP­
00047,
OMPP­
00048,
OMPP­
00049,
OMPP­
00050,
OMPP­
00051,
OMPP­
00053,
OMPP­
00055,
OMPP­
00056,
OMPP­
00057,
OMPP­
00058,
OMPP­
00059,
OMPP­
00060,
OMPP­
00061,
OMPP­
00062,
OMPP­
00063,
OMPP­
00064,
OMPP­
00065.

EPA
Response:
EPA
appreciates
the
commenters'
strong
support
for
today's
site­
specific
rule.

Comment:
In
addition
to
the
above
comment,
one
commenter
(
Department
of
Energy's
Lawrence
Berkeley
National
Laboratory)
cites
another
example
of
success
with
the
catalytic
oxidation
process
based
on
data
collected
at
their
laboratory
and
notes
that
petitions
for
delistings
were
submitted
to
the
Agency
by
the
laboratory
that
further
support
the
performance
of
this
process.

EPA
Response:
This
rulemaking
pertains
to
a
site­
specific
pilot
to
treat
waste
without
a
permit.
Thank
you
for
submitting
the
results
of
these
studies.
The
data
is
supportive
of
the
rulemaking
and
is
consistent
with
the
data
submitted
by
OMP.
Berkeley's
delisting
petitions,
however,
are
not
relevant
to
today's
rulemaking.
EPA
appreciates
this
commenter's
strong
support
for
today's
site­
specific
rule.

Comment:
These
comments
on
the
above
referenced
proposed
rulemaking
are
submitted
on
behalf
of
the
Council
on
Radionuclides
and
Radiopharmaceuticals
(
CORAR)
1.
7
CORAR
members
and
their
customers
in
the
medical
and
research
community
generate
mixed
waste
and
are
therefore
interested
in
this
proposed
rule.

CORAR
has
repeatedly
expressed
concern
to
the
U.
S.
Environmental
Protection
Agency
(
EPA)
that
the
current
regulatory
framework
for
mixed
waste
is
counterproductive
and
prevents
generators
from
pro
actively
minimizing
and
safely
disposing
of
mixed
waste.
CORAR
recognizes
that
the
EP
A
is
attempting
to
remove
the
current
regulatory
impasse
and
supports
these
developments.

CORAR
supports
the
proposed
rule
to
exempt
the
Ortho­
McNeil
Pharmaceuticalsite
specific
mixed
waste
treatment
process
from
RCRA
requirements.
CORAR
supports
this
rulemaking
because
the
EP
A
intends
to
use
this
project
to
obtain
information
to
justify
a
similar
generally
applicable
national
exemption
for
this
treatment
process.

However,
although
CORAR
supports
the
proposed
rule
and
EPA's
stated
intent,
we
are
concerned
that
the
entire
effort
has
taken
so
long.
More
importantly
we
are
concerned
that
this
represents
only
a
partial
solution
to
the
mixed
waste
regulatory
problem.
Ultimately
the
EPA
should
be
moving
to
completely
eliminate
dual
regulation
of
mixed
waste.
CORAR
asserts
that
dual
regulation
can
be
mostly
eliminated
if
EPA
transferred
regulatory
authority
for
mixed
waste
containing
byproduct
material
to
the
NRC
and
Agreement
States.

Furthermore
the
EPA
should
also
exempt
mixed
waste
containing
accelerator
produced
radioactive
materials
from
RCRA
when
these
wastes
are
managed
by
a
generator
who
is
also
an
NRC
or
Agreement
State
licensee
in
accordance
with
their
byproduct
license
conditions.
CORAR
strongly
urges
that
the
EPA
consults
with
the
NRC
to
determine
whether
treatment
of
mixed
waste
can
be
safely
carried
out
by
NRC
licensees
without
a
RCRA
permit.

It
is
CORAR's
expectation
that
consultation
with
the
NRC
will
enable
the
EPA
to
learn
that
NRC
and
Agreement
State
licensed
research
facilities
and
their
manufacturer
suppliers
safely
use
virtually
every
chemical
processing
method
known,
including
a
variety
of
high­
temperature
catalytic
oxidation
processes,
to
make
and
use
radioactive
materials
and
chemicals
with
hazardous
characteristics.
These
practices
have
been
safely
conducted
for
many
decades
with
negligible
off­
site
impact
and
far
below
regulatory
limits.
EPA
regulation
of
any
such
practices
because
they
involve
the
handling
of
"
wastes"
at
best
adds
no
value
to
the
overall
objectives
of
health,
safety
and
environmental
protection,
and
at
worst
is
counterproductive.

CORAR
therefore
supports
this
proposed
rule,
urges
EPA
to
expand
its
applicability
nationally
and
recommends
that
EPA
should
simultaneously
pursue
the
complete
elimination
of
dual
regulation
by
collaborating
with
the
NRC
to
this
effect.
We
have
attached
specific
comments
which
we
hope
will
be
useful.

CORAR
appreciates
the
opportunity
to
comment
on
this
proposed
rule
and
would
be
glad
to
provide
any
further
information
or
clarification.
8
EPA
Response:
EPA
appreciates
the
commenter's
general
support
for
the
rule
and
responds
to
its
specific
comments
below.

Comment
1.
Page
38396,
Col.
1,
§
1
"
Project
XL
Site­
Specific
Rulemaking
for
the
Ortho­
McNeil
Pharmaceutical,
Inc.
Facility
in
Spring
House,
Pennsylvania."

a.
This
heading
appeared
in
the
contents
section
of
the
Federal
Register.
It
does
not
indicate
that
the
topic
addresses
radioactive
material
or
mixed
waste.
Because
of
this
omission
numerous
organizations
who
have
an
interest
in
these
subjects
were
unaware
of
the
rulemaking
and
or
were
unable
to
submit
timely
comments.

b.
CORAR
recommends
that
in
future
publications
of
this
type
the
subject
matter
should
be
clearly
defined
in
the
title.

Response
1.
EPA
will
consider
the
commenter's
recommendation
in
future
notices
of
this
type.

Comment
2.
Page
38396,
Col.
3,
§
3
"
All
other
hazardous
wastes
generated
and/
or
managed
at
the
OMP
facility
remain
subject
to
current
RCRA
subtitle
C
regulations.
Similarly,
mixed
wastes
generated
in
other
pharmaceutical
research
and
development
facilities
remain
subject
to
current
RCRA
regulations."

a.
These
statements
appear
to
contradict
EPA's
conditional
exemption
for
the
treatment
of
mixed
waste
in
tanks
and
containers
and
for
allowing
mixed
waste
containing
short
lived
radioactive
materials
to
be
held
for
decay
under
U.
S.
Nuclear
Regulatory
Commissions
(
NRC)
and
Agreement
State
regulations.

b.
CORAR
recommends
that
this
section
be
revised
in
the
final
rule
to
prevent
confusion.

Response
2.
To
be
clear,
nothing
in
today's
final
rule
affects
OMP's
ability
to
claim
any
other
available
conditional
exemptions
from
hazardous
waste
regulations
applicable
to
any
hazardous
waste
generated
or
managed
at
it's
Spring
House,
Pennsylvania
facility.
EPA
has
added
language
to
the
preamble
for
the
final
rule
to
eliminate
any
confusion
by
noting
that
exemptions
and
exclusions
from
regulatory
requirements
(
which
include
the
exemptions
referred
to
by
the
commenter)
are
considered
to
be
included
within
the
term
"
RCRA
Subtitle
C
regulations."

Comment
3.
Page
38396,
Col.
3,
§
3
and
Page
38397,
Col.
1,
§
1
"
The
pilot
project
will
also
provide
the
Agency
additional
data
regarding
the
performance
of
the
on­
site,
bench­
scale
hightemperature
catalytic
oxidation
unit
used
to
treat
the
mixed
wastes,
which
will
also
be
considered
as
a
part
of
any
future
determination
regarding
the
implementation
of
the
regulatory
flexibility
on
a
national
basis."

a.
CORAR
is
concerned
that
the
EPA
has
taken
5
years
to
propose
this
site
specific
rule
and
may
9
take
another
five
years
to
promulgate
a
rule
with
national
applicability
.

b.
The
NRC
usually
takes
a
few
weeks
to
a
few
months
to
routinely
make
similar
decisions
for
individual
sites
when
processing
license
and
license
amendment
applications.

c.
Since
the
NRC
licensing
process
is
proven
to
be
effective
and
also
provides
for
occupational
protection
it
is
clear
that
the
EPA
should
transfer
oversight
on
the
use
of
this
technology
to
the
NRC.

d.
The
EPA
should
be
aware
that
radiochemical
manufacturers
have
several
decades
of
experience
in
safely
using
catalytic
high­
temperature
oxidation
methods
to
manufacture
products
and
to
process
low­
level
radioactive
wastes
in
accordance
with
NRC
and
Agreement
State
regulations
and
license
conditions.
The
radiochemicals
and
hazardous
,
hemicals
used
are
identical
to
those
found
in
mixed
waste.

e.
It
is
clear
that
the
EP
A
should
defer
to
NRC
oversight
and
allow
such
licensees
to
use
the
same
processes
for
the
much
smaller
quantities
of
mixed
waste.

Response
3.
EPA
notes
the
commenter's
concerns,
but
believes
that
the
five
year
review
period
for
evaluating
this
XL
project
is
reasonable
and
will
provide
adequate
information
on
which
to
make
future
decisions
regarding
the
regulation
of
bench­
scale
high­
temperature
catalytic
oxidation
treatment
of
small
volumes
of
mixed
waste.
EPA
appreciates
the
commenter's
information
on
radiochemical
manufacturers,
but
notes
that
such
information
is
beyond
the
scope
of
the
current
rulemaking.

Comment
4.
Page
38398,
Col.
2,
§
4
and
Col.
3,
§
1
"
OMP
does
not
believe
the
RCRA
Subtitle
C
regulatory
controls,
as
applied
to
the
LLMW...
provide
any
additional
environmental
protection
than
is
otherwise
provided
by
AEA
oversight,
RCRA
serve
as
a
major
disincentive...

CORAR
agrees
with
the
concerns
expressed
in
these
paragraphs.
The
cost
of
obtaining
a
RCRA
permit
or
using
a
RCRA
permitted
commercial
treatment
facility
to
process
mixed
waste
is
often
prohibitive
and
prevents
the
provision
of
products,
services
and
research
that
is
vitally
important
to
society.
A
similar
conclusion
was
recently
published
by
the
National
Academy
of
Sciences
in
"
The
Impact
of
Low­
Level
Radioactive
Waste
Management
Policy
on
Biomedical
Research
in
the
United
States".
Washington,
DC,
2001.

Response
4.
EPA
notes
the
commenter's
agreement
with
EPA
on
this
point.

Comment
5.
Page
38398,
Col.
3,
§
2
"
NRC...
with
jurisdiction
over
the
radioactive
component
of
the
waste."

a.
The
Atomic
Energy
Act
assigns
jurisdiction
over
radioactive
materials,
which
are
byproducts
10
from
nuclear
reactors,
to
the
NRC.

b.
NRC
is
responsible
for
oversight
of
public
and
occupational
radiation
exposure
from
byproduct
material
and
must
consider
the
total
radiation
exposure
to
individuals
from
controllable
man­
made
sources
of
radiation
including
accelerator
produced
radiation
when
individuals
are
exposed
to
radiation
from
both
sources.

c.
To
ensure
proper
control
of
radiation
exposure
it
is
also
necessary
for
the
NRC
to
consider
facility
and
operational
characteristics
that
might
contribute
to
radiation
exposure.
Consequently,
the
NRC
has
considerable
expertise
and
experience
in
oversight
of
hazardous
chemicals
and
fire
and
explosion
control
and
regularly
reviews
these
characteristics
and
practices
when
inspecting
licensees
and
developing
license
conditions.
The
NRC's
involvement
includes
radiochemicals,
radiochemicals
that
have
hazardous
chemical
characteristics,
mixtures
containing
radiochemicals
and
hazardous
chemicals
and
even
facilities
where
radiochemicals
and
hazardous
chemicals
are
separate,
but
in
the
same
building
complex.

d.
This
is
why
NRC
and
Agreement
States
regulations,
licensing
and
enforcement
practices
are
fully
protective
for
licensees
managing
processes
involving
both
radioactive
materials
and
hazardous
chemicals,
regardless
of
whether
the
practice
involves
what
EPA
has
defmed
as
"
waste".

e.
This
is
why
CORAR
recommends
that
EPA
should
transfer
jurisdiction
over
mixed
waste
to
the
NRC.

Response
5.
EPA
notes
the
commenter's
recommendation,
but
views
the
recommendation
as
going
beyond
the
scope
of
today's
site­
specific
rule.

Comment
6.
Page
38398,
Col.
3,
§
4
"
Members
of
the
regulated
community
have
raised
concerns
that
this
dual
regulatory
oversight
of
low­
level
mixed
waste..
..
is
excessively
burdensome,
duplicative
and
costly
without
providing
any
additional
protection
of
human
health
and
the
environment
than
that
achieved
under
one
regulatory
require."

a.
CORAR
has
frequently
commented
to
the
EP
A
on
this
subject
and
agrees
with
the
above
statement.

b.
CORAR
asserts
that
currently
the
NRC
provides
the
best
regulatory
framework
for
mixed
waste
because
it
effectively
provides
for
both
general
and
specific
site
control
of
both
the
radioactive
and
hazardous
chemical
component
of
the
waste
and
a
broad
range
of
treatment
and
storage
practices
to
comprehensively
provide
occupational,
public
and
environmental
protection.

Response
6.
EPA
notes
the
commenter's
assertion
and
views
it
as
supporting
today's
site­
specific
rule.

Comment
7.
7.
Page
38399,
Col.
1,
§
3
"...
the
conditional
exemption
[
for
Mixed
Waste]
allows,
,
11
a
generator
to
treat
LLMW
...
under
a
NRC...
license,
in
tanks
or
containers..."

a.
CORAR
supported
EPA's
conditional
exemption
rule,
but
pointed
out
that
the
rule
was
insufficient
because
it
did
not
eliminate
dual
regulation
and
did
not
include
accelerator
produced
radioactive
materials
nor
thermal
treatment
practices
that
can
be
safely
conducted
by
NRC
licensees
who
have
the
necessary
expertise
and
experience.

b.
CORAR
recommends
that
EPA
should
enter
into
a
Memorandum
of
Understanding
with
the
NRC
to
transfer
authority
over
mixed
waste.

c.
CORAR
recommends
that
the
EPA's
conditional
exemption
should
be
applied
to
mixed
waste
involving
accelerator
produced
radioactive
material
when
the
generator
is
an
NRC
or
Agreement
State
licensee
and
uses
the
same
controls
as
those
specified
in
their
license
for
byproduct
materials.

Response
7.
EPA
appreciates
the
commenter's
recommendations,
but
note
that
these
comments
and
recommendations
do
not
address
today's
site­
specific
rule.

Comment
8.
Page
38399,
Col.
1,
§
4
"
The
treatment
technology
being
employed
by
OMP
is
not
exempted
under
the
Mixed
Waste
Rule
because
it
does
not
within
a
tank
or
container."
a.
This
sentence
does
not
make
grammatical
sense.

b.
The
EPA
should
be
aware
that
high
temperature
catalytic
oxidation
conversion
processes
are
safely
used
in
containers.

c.
CORAR
recommends
that
the
use
of
high­
temperature
catalytic
oxidation
conversion
processes
for
the
treatment
of
mixed
waste
should
also
be
exempt
from
RCRA
requirements
when
the
practice
is
conducted
according
to
the
conditions
of
an
NRC
or
Agreement
State
license.

d.
CORAR
recommends
that
the
final
mixed
waste
rule
(
66
FR
27217)
be
revised
to
remove
the
tank
and
container
limitation.

Response
8.
a.
The
sentence
quoted
by
commenter
found
at
66
FR
38399
is
missing
a
word.
The
sentence
was
intended
to
read:
"
The
treatment
technology
being
employed
by
OMP
is
not
exempted
under
the
Mixed
Waste
Rule
because
it
does
not
occur
within
a
tank
or
container."

b.
Based
on
information
submitted
by
OMP,
EPA
determined
that
OMP's
treatment
process
does
not
occur
in
a
tank
or
container.

c.
EPA
notes
the
commenter's
recommendation
and
views
it
as
supporting
today's
site­
specific
rule.
12
d.
The
commenter's
recommendation
regarding
an
amendment
to
the
mixed
waste
rule
(
40
CFR
Part
266
Subpart
N
is
not
relevant
to
today's
site­
specific
rule.

Comment
9.
Page
38399,
Col.
2,
§
3
"...(
yielding
water
and
C
2)..."

a.
Replace
"
C
2"
with
"
Co
2".

Response
9.
EPA
will
correct
the
typographical
error
in
the
final
preamble.

Comment
10.
Page
38400,
Col.
1,
§
3
and
Col.
2,
§
1
"...
the
treatment
process
exceeds
LDR
treatment
standards
for
organics
and
only
negligible
amounts
of
radioactivity
are
released2"

a.
EPA
has
considered
the
release
to
the
environment
of
radioactive
materials,
but
has
not
identified
the
hazardous
chemical
components
or
the
quantities
of
these
which
are
released
to
the
environment.

b.
In
footnote
1
to
this
statement
"
This
volume
of
air.
emissions"
should
be
replaced
by
"
These
annual
average
concentrations
of
radionuclides
in
effluent
air".
Also
the
limits
in
10CFR20
quoted
for
tritium
and
carbon­
14
are
incorrect.
The
limits
should
be
10­
7

Ci/
mL
for
tritium
and
3
x
10­
7

Ci/
mL
for
14CO2
or
3
x
10­
9

Ci/
mL
for
14C­
compounds
as
specified
in
10CFR20.

c.
It
is
not
clear
in
this
section
whether
the
14C
released
as
effluent
air
is
in
the
fonn
of
14CO
2
or
other
radiocompounds.

d.
While
the
concentration
of
hazardous
chemicals
and
radioactive
materials
is
of
technical
interest
there
is
no
explanation
to
the
public
of
the
significance
of
these
releases.
CORAR
recommends
that
the
EP
A
should
give
a
realistic
indication
of
the
actual
impact
that
such
releases
could
have
on
the
maximally
exposed
member
of
the
public
living
or
working
near
the
generator's
facility.

e.
While
the
EP
A
claims
that
the
concentration
air
emissions
from
OMP
are
less
than
0.05%
of
the
NRC
IOCFR20
concentration
limit
the
actual
impact
on
members
of
the
public
should
be
very
much
lower
than
0.05%
of
NRC
regulatory
limit
for
exposure
to
individual
members
of
the
public.
It
is
simple
to
show
that
the
maximum
dose
to
individuals
who
reside
at
about
100
meters
from
the
point
of
discharge
would
be
about
0.00001%
of
the
NRC
dose
limit.
This
annual
radiation
dose
is
roughly
equal
to
the
average
radiation
received
in
1
second
from
natural
background
radiation
sources
in
an
individual's
own
home.
..

f.
Both
the
International
Commission
on
Radiological
Protection
(
ICRP)
and
the
National
Council
on
Radiation
Protection
and
Measurements
(
NCRP)
recommend
that
any
sources
that
cause
13
public
exposures
of
less
than
1
mrem
per
year
are
negligible
and
should
not
be
regulated.
This
recommended
negligible
amount
appears
to
be
100,000
times
higher
than
the
impact
from
OMP's
emissions.
Hence
OMP's
emissions
should
not
be
regulated
by
any
agency
including
either
the
NRC
or
EPA.

Response
10a.
As
discussed
in
the
preamble,
OMP
uses
organic
compounds
to
develop
the
radiolabeled
compounds
used
to
study
the
bioabsorption
and
metabolism
of
the
pharmaceuticals/
drugs
being
developed.
The
radiolabeled
compound
is
composed
of
an
isotopically
labeled
organic
compound
and
a
solvent,
with
the
specific
solvent
used
being
dependent
upon
the
specific
research
being
conducted.
Thus
the
Agency
does
not
believe
it
necessary
to
identify
the
specific
solvents
being
used
(
which
will
be
identified
when
OMP
submits
its
annual
reports),
only
that
a
significant
portion
of
the
solvents
used
would
otherwise
be
subject
to
regulation
as
hazardous
wastes
when
spent
(
and
thus
be
defined
as
mixed
wastes)
under
RCRA.

Response
10b.
We
agree
that
the
language
in
the
footnote
should
be
changed
to
"
These
annual
average
concentrations
of
radionuclides
in
effluent
air."
We
also
agree
that
the
NRC
emission
limits
that
were
reported
in
Footnote
1
in
1999
appear
to
no
longer
be
valid.
The
tritium
effluent
concentration
as
stated
in
Footnote
1
("
2.00E­
8
mCi/
mL
for
tritium")
should
be
changed
to
read
"
1
x
10­
7
mCi/
mL".
The
effluent
concentration
for
carbon­
14
should
read
3
x
10­
7
mCi/
mL
((
present
as
carbon
dioxide­
14C)
and
not
"
6.00E­
8
mCi/
mL"
as
stated
in
the
footnote.

c.
As
stated
in
the
preamble,
the
treatment
of
carbon­
14
labeled
compounds
generates
radioactive
CO
2,
which
is
then
passed
through
a
potassium
hydroxide
solution
and
thus
converted
to
potassium
carbonate.
No
releases
of
14C
as
effluent
air
are
expected,
but
should
such
a
release
occur,
the
form
of
the
14C
would
be
radioactive
CO
2.

d.,
e.,
and
f.,
The
Agency
notes
that
these
three
comments
are
very
closely
related
and
linked.
In
comment
d.,
the
commenter
suggests
EPA
provide
the
public
a
realistic
indication
of
the
actual
impact
that
a
potential
release
would
have
on
the
maximally
exposed
member
of
the
public
living
or
working
near
the
generator's
facility.
In
comment
e.,
the
commenter
provides
that
indication
by
stating
that
the
annual
dose
would
be
roughly
equal
to
the
average
background
radiation
received
in
one
second
from
natural
background
radiation
sources
in
an
individual's
home.
In
comment
f,
the
commenter
expresses
the
belief
that
the
potential
radiation
exposure
levels
are
negligible
and
should
not
be
regulated
by
either
the
NRC
or
EPA.
While
the
Agency
acknowledges
that
the
risks
from
potential
releases
are
extremely
small
(
which
is
one
reason
the
Agency
believes
this
is
an
appropriate
innovative
pilot
project
to
pursue),
the
comments
speak
to
broader
national
policy
considerations
that
are
beyond
the
scope
of
today's
site­
specific
rulemaking.

Comment
11.
P
.38400,
Col.
3,
§
2
and
P.
38401,
Col.
1,
§
3
"...
for
OMP
to
continue
to
be
able
to
treat
the
small
volumes
of
mixed
wastes
within
the
same
laboratory
that
created
the
14
wastes...".
"
While
the
Agency
continues
to
maintain...
mixed
waste
treatment
professes
that
cannot
be
undertaken
in
a
tank
or
container
warrant
RCRA
oversight..."

a.
CORAR
not
only
supports
this
conclusion
but
also
does
not
believe
aMP
should
be
limited
to
the
current
scope
and
location
of
pilot
operations
as
long
as
any
other
practice
is
carried
out
in
accordance
with
an
NRC
license.

b.
As
previously
discussed,
NRC
licensed
activities
that
involve
the
processing
of
hazardous
and
radioactive
chemicals
are
carried
out
without
EP
A
oversight
and
without
health,
safety
or
environmental
impairment.
CORAR
does
not
agree
with
the
EP
A
position
that
because
waste
treatment
processes
are
somehow
unique,
regardless
of
whether
they
are
conducted
in
a
tank
or
container,
they
are
subject
to
EP
A
regulation.

Response
11.
a.
EPA
disagrees
with
the
commenter's
general
assertion
that
OMP
should
not
be
limited
by
the
terms
of
the
rule
as
long
as
"
any
other
practice
is
carried
out
in
accordance
with
an
NRC
license."
For
the
reasons
expressed
in
the
preamble,
EPA
believes
the
conditions
established
in
the
site­
specific
exclusion
are
reasonable
and
ensure
that
this
pilot
project
is
protective
of
human
health
and
the
environment.

b.
It
is
not
clear
what
the
commenter's
remark
means.
However,
to
the
extent
that
the
commenter
is
suggesting
that
EPA
does
not
have
regulatory
authority
over
the
hazardous
component
of
mixed
waste,
EPA
strongly
disagrees.
EPA's
regulatory
authority
over
mixed
waste
is
well
established.
See
66
FR
27217
(
May
16,
2001).

Comment
12.
P.
38400,
Col.
3,
§
3
"
OMP
...
could
increase
from
the
current
10
curies/
year
to
approximately
50
curies/
year"
.

a.
It
is
not
clear
whether
the
curies
stated
are
3H
or
14C
or
both
radionuclides.

b.
In
either
case
10
curies
of
either
3H
or
14C
released
in
air
effluent
during
a
year
would
have
a
negligible
effect.
For
measurable
scenarios,
maximum
doses
to
members
of
the
public
near
the
facility
would
be
far
below
1
mrem/
year
for
3H
or
14CO
2
and
about
0.2
mrem
for
l0
Ci
of
14Ccompounds
using
NRC's
conservative
default
values.
Hence
this
would
be
considered
negligible
and
not
worth
regulating
by
the
NCRP
and
ICRP.

c
EPA
should
be
aware
that
manufacturing
facilities
in
urban
locations
that
routinely
process
tens
of
thousands
of
curies
of
3H
and
equivalent
quantities
of
14C­
compounds
using
a
wide
variety
of
processes,
including
high
temperature
catalytic
oxidation,
with
mostly
limited
containment
have
annual
off­
site
impacts
that
are
typically
less
than
1/
1000
of
the
regulatory
limit
and
well
below
the
negligible
level
recommended
by
the
NCRP
and
ICRP
Response
12a.
The
curies
stated
are
both
3H
and
14C.
As
described
in
the
discussion
of
the
laboratory
practices
at
the
facility,
both
tritium
and
carbon­
14
are
used.
When
tritium
is
treated,
15
3H
is
generated,
and
when
carbon­
14
is
treated,
14C
(
in
the
form
of
radioactive
carbon
dioxide)
is
generated
(
and
subsequently
converted
to
radioactive
potassium
carbonate).
Thus
the
estimate
of
the
potential
increase
in
the
volume
of
curies
that
would
be
generated
in
the
laboratory
was
intended
to
reflect
the
total
combination
of
radioactive
materials.

Response
12b.
The
Agency
agrees
with
the
commenter
that
the
volumes
of
curies
at
issue
are
very
small
and
would
have
negligible
effect.
The
Agency
accepts
this
comment
as
supportive
of
this
rulemaking.

Response
12c.
The
Agency
acknowledges
the
commenter's
statement
and
considers
the
comment
to
be
supportive
of
this
rulemaking.

Comment
13.
P.
38400,
Col.
3,
§
4
and
P.
38401,
Col.
1,
§
1
"[
EPA]
is
proposing
in
today's
notice
to
provide
a
site­
specific
exclusion
in
40CFR261.4(
b)
(
i.
e.,
"
Solid
wastes
which
are
not
hazardous
wastes")
for
the
mixed
wastes
generated
and
treated
in
OMP's...
R&
D
laboratory
Instead
of
being
considered
"
mixed
wastes,"
these
wastes
will
simply
be
considered
low­
level
wastes...
subject
to
NRC..
regulation.
Further,...,
no
"
delisting"
is
required
for
these
residuals
(
since
the
original
wastestream
was
not
a
RCRA
"
listed"
waste)...".

a.
CORAR
supports
the
intent
of
this
EPA
proposed
rule
change
in
40CFR261.4(
b).

b.
CORAR
also
recognizes
that
the
EPA
has
the
authority
to
establish
regulatory
interpretations
such
as
this
and
the
one
classifying
liquid
waste
forms
as
"
solid
waste",
even
though
these
interpretations
are
illogical
or
counter
intuitive.

c.
It
appears
necessary
to
establish
these
confusing
regulatory
interpretations
because
the
EPA
regulatory
framework
is
inadequately
designed
for
achieving
the
regulatory
outcome
that
is
being
sought.
This
is
another
example
of
why
regulatory
oversight
should
be
transferred
to
the
NRC
and
Agreement
States
whose
regulatory
frameworks
are
comprehensive
and
are
well
designed
to
address
site
specific
conditions
through
the
licensing
process.

Response
13.
EPA
appreciates
the
commenter's
support
for
this
rule
and
notes
the
commenter's
general
observations
about
the
RCRA
program
that
are
not
relevant
to
today's
site­
specific
rule.

Comment
14.
Page
38402,
Col.
1,
§
s
2
and
3
"
G.
How
Will
This
Project
Result
in
Cost
Savings
and
Paperwork
Reduction?..."

a.
The
cost
data
presented
in
these
paragraphs
is
insufficient
to
answer
basic
economic
questions.
For
example,
it
is
not
stated
whether
the
$
20,000
­$
35,000
per
curie
rate
is
only
for
treatment
or
for
subsequent
disposal.
Consequently,
it
is
not
clear
whether
the
$
300,000
is
the
actual
cost
savings.
It
appears
that
this
number
is
an
estimate
of
the
difference
between
two
processes.
However,
it
seems
that
the
use
of
an
outside
vendor
operating
with
a
RCRA
permit
is
not
a
16
viable
alternative.
Hence
the
cost
saving
should
be
estimated
from
considering
past
practice
which
is
to
store
the
material
until
the
regulations
change.

b.
It
would
be
useful
if
the
EPA
could
compare
the
cost
of
using
this
treatment
process
under
a
RCRA
permit
compared
with
under
NRC
licensee's
conditions.

Cost
consideration
should
include
the
cost
of
permits,
documentation,
reporting
and
subsequent
safe
disposal
of
the
end
products
to
meet
all
current
regulatory
requirements.

Response
14a.
The
$
300,000
figure
was
a
rough
estimate
based
primarily
on
the
costs
of
off­
site
treatment
and
disposal
 
i.
e.,
the
cost
for
off­
site
waste
management.
This
estimate
did
not
accurate
reflect
the
alternative
costs
of
operating
the
high
temperature
catalytic
oxidization
unit
or
management
of
the
low­
level
radioactive
waste.
The
key
point
of
the
economic
discussion
was
to
reflect
the
significant
costs
that
would
otherwise
be
incurred
with
what
OMP
believes
is
no
environmental
benefit
(
i.
e.,
that
the
on­
site
treatment
can
be
conducted
as
safely,
if
not
more
so,
than
RCRA
permitted
and
NRC
licensed
off­
site
treatment.
EPA
disagrees
that
the
baseline
cost
consideration
should
be
long­
term
storage,
but
rather
believes
the
appropriate
consideration
should
be
the
off­
site
treatment
and
disposal
of
the
mixed
wastes.
Under
the
current
program,
treatment
and
disposal
in
a
RCRA
permitted
NRC
licensed
facility
is
the
allowable
off­
site
waste
management
alternative
to
long­
term
storage.
Had
the
Agency
used
long­
term
storage
as
the
economic
baseline,
the
baseline
would
not
have
reflected
the
regulatory
costs
associated
with
maintaining
RCRA
jurisdiction
over
these
materials
when
they
are
treated
and
disposed
(
which
is
one
of
the
aspects
being
evaluated
by
this
pilot
project).

b.
EPA
understands
the
commenter's
suggestion
that
the
Agency
compare
the
costs
of
RCRA
permitting
to
NRC
licensing
for
the
HTCO
process.
However,
insofar
as
this
is
a
site­
specific
rulemaking,
that
Agency
believes
it
is
more
appropriate
to
focus
on
the
specific
considerations
relevant
to
the
site.
In
this
case,
OMP
was
(
and
remains)
clear
that
seeking
a
RCRA
permit
was
not
a
viable
option.
Off­
site
waste
management
is
the
only
realistic
alternative
that
OMP
would
consider.
The
Agency
agrees
that
if
this
regulatory
flexibility
is
considered
on
a
national
scale,
an
economic
comparison
as
suggested
by
the
commenter
could
be
a
more
useful
component
of
a
more
generic
economic
analysis.

Comment:
OMPP­
00029
Although
the
Department
[
of
Energy]
supports
this
action,
two
technical
comments
are
offered
for
EPA's
consideration.
First,
the
Department
suggests
that
EPA
revise
its
proposed
regulatory
language
under
40
CFR
261.4(
b)(
17)
by
replacing
"
mixed
waste"
with
the
phrase
"
low­
level
waste."
As
proposed,
using
the
term
"
mixed
waste"
may
be
misleading.
Specifically,
RCRA
as
amended
by
the
Federal
Facility
Compliance
Act
of
1992,
defines
the
term
"
mixed
waste"
as
"
waste
that
contains
both
hazardous
waste
and
source,
special
nuclear,
or
byproduct
material
subject
to
the
AEA."
However,
since
EPA
proposes
to
explicitly
exclude
the
OMP
radioactive/
organic
waste
mixture
from
being
hazardous
(
i.
e.
the
proposed
regulatory
17
provision
falls
under
§
261.
4(
b
)
which
identifies
"
solid
wastes
which
are
not
hazardous
wastes"),
it
would
not
be
appropriate
to
refer
to
the
OMP
waste
mixture
as
a
"
mixed
waste."

Second,
a
discussion
in
the
preamble
(
at
66
EB.
38401,
col.
1)
states
that,
because
the
residuals
resulting
from
the
OMP
"
treatment
process
will
not
be
derived
from
hazardous
wastes,
no
"
delisting"
is
required
for
these
residuals
(
since
the
original
wastestream
was
not
a
RCRA
"
listed"
waste)."
DOE
notes
that
the
above
parenthetical
statement
could
be
misleading
since
readers
might
infer
it
to
mean
that
delistings
would
be
necessary
for
treatment
residuals
if
the
original
OMP
waste
meets
a
listing
description
(
e.
g.,
F001
­
F005).
DOE
points
out
that,
as
proposed,
each
contaminated
aqueous
mixture
will
be
excluded
from
RCRA
Subtitle
C
regulation
at
its
point
of
generation
(
assuming
all
the
specified
conditions
are
met).
Thus,
whether
the
original
waste
stream
would
otherwise
meet
a
listing
or
exhibit
a
characteristic
has
no
bearing
on
the
RCRA
status
of
its
treatment
residual,
since
the
residual
would
be
derived
from
an
excluded
waste.
If
this
type
of
discussion
is
included
in
the
pre~~
I.
e.~
o
the
final
rule,
DOE
suggests
that
EPA
modify
the
parenthetical
to
read
as
follows
[
font
=
addition;
strikeout
font
=
deletion]:

...
no
"
delisting"
is
required
for
these
residuals
(
since
the
original
wastestream
was
not
a
RCRA
"
listed"
waste
).

DOE
recognizes
that
pilot
projects
such
as
the
OMP
XL
project
are
important
in
Agency
efforts
to
consider
new
strategies
that
reduce
regulatory
burdens
and
promote
economic
growth
while
achieving
better
environmental
and
public
health
protection.
Provided
EPA
finds
this
XL
pilot
project
to
be
a
success,
the
Department
encourages
the
Agency
to
expedite
the
implementation
of
this
regulatory
flexibility
on
a
nationwide
basis.
Such
relief
could
alleviate
RCRA
permitting
related
time
and
resource
constraints
that
currently
act
as
a
disincentive
to
the
development
of
environmentally
protective
on­
site
treatment
for
other
small
volumes
of
research
and
development
laboratory­
generated
mixed
wastes.

EPA
Response:
In
addition
to
supporting
EPA's
rule,
this
commenter
offers
two
technical
comments
for
EPA's
consideration.
The
first
suggestion
is
that
EPA
revise
its
proposed
regulatory
language
by
replacing
the
term
"
mixed
waste"
with
the
term
"
low­
level
waste".
The
commenter
states
that
using
the
term
"
mixed
waste"
in
the
rule
may
be
misleading.
The
commenter
points
out
that
by
statute
the
term
"
mixed
waste"
contains
both
a
RCRA
hazardous
waste
and
source,
special
nuclear,
or
by­
product
material
subject
to
the
AEA,
but
by
operation
of
the
rule
waste
generated
and
treated
using
an
on­
site
bench­
scale
high
temperature
catalytic
oxidation
unit
at
OMP's
facility
are
excluded
from
being
hazardous
waste.
Therefore,
according
to
the
commenter
the
rule
should
not
refer
to
these
wastes
as
"
mixed
waste".
EPA
agrees
that
use
of
the
term
"
mixed
waste"
could
cause
confusion
in
this
context,
but
does
not
agree
that
the
rule
should
use
the
term
"
low­
level
waste".
If
"
low
level
waste"
contains
only
source,
special
nuclear,
or
by­
product
material
subject
to
the
AEA,
then
the
waste
is
excluded
from
RCRA
jurisdiction
because
it
is
outside
the
scope
of
the
statutory
definition
of
"
solid
waste".
Therefore,
using
the
term
"
low
level
waste"
would
also
be
inappropriate.
18
To
eliminate
possible
confusion
EPA
has
revised
the
rule
text
to
substitute
the
term
"
solid
waste"
for
"
mixed
waste"
and
to
replace
a
reference
to
§
261.3
with
a
reference
to
the
mixed
waste
rule
at
§
266.10.
Thus
the
rule
now
reads
as
follows:

"(
17)
Solid
waste
that
would
also
otherwise
meet
the
definition
of
mixed
waste
pursuant
to
§
266.210
that
is
generated
and
treated
using
an
on­
site
bench­
scale
high
temperature
catalytic
oxidation
unit
at
the
Ortho­
McNeil
Pharmaceutical,
Inc.
(
OMP)
research
and
development
facility
in
Spring
House,
Pennsylvania
are
excluded
from
the
definition
of
hazardous
waste
.
.
."

The
Commenter's
second
technical
comment
.
.
.
EPA
agrees
with
the
commenter
and
will
revise
its
discussion
in
the
final
preamble
as
the
commenter
has
suggested.

Comment:
OMPP­
00002
I
am
writing
on
behalf
of
ATG,
Inc.,
a
RCRA/
TSCA
permitted
(
EPA
ID
No.
WAR00001035)
and
NRC
Licensed
facility
(
WN­
I0508­
1),
in
opposition
to
the
abovereferenced
rule.

ATG
is
a
RCRA
permitted
commercial
processor
of
low­
level
mixed
waste,
such
as
that
addressed
by
the
proposed
rule
change.
ATG
has
recently
completed
the
construction
of
a
thermal
treatment
facility
for
mixed
waste
at
a
cost
of
$
35M.
The
annual
capacity
of
our
plant
for
mixed
wastes,
such
as
the
subject
of
this
rule,
is
over
1,000,000
pounds.

Based
on
our
experience
with
operating
a
mixed
waste
treatment
facility
for
nearly
two­
years,
we
have
the
following
concerns
regarding
the
general
approach
to
waste
treatment
advocated
by
the
proponents
of
this
rule.

1.
The
potential
for
release
of
large
quantities
of
radioactive
materials
in
heavily
populated
areas
where
many
pharmaceutical
laboratories
are
located
due
to
equipment
malfunction
and
consequent
adverse
public
reaction.

2.
The
disincentive
such
a
program
provides
to
commercial
treatment
facilities
to
expand
capacity
and
improve
services.

Since
the
OMP
XL
(
Ortho­
McNeil
Pharmaceutical
Excellence
and
Leadership)
project
was
proposed,
considerable
commercial
capacity
for
treating
liquid
mixed
wastes
has
come
on
line,
most
notably
ATG's
own
Mixed
Waste
Facility
in
Richland,
W
A.

Treating
pharmaceutical
waste
in
a
RCRA
permitted
commercial
facility
such
as
ours
provides
the
following
advantages:

1.
General
availability
of
treatment
options
sooner,
19
2.
Lower
total
cost
nationally
by
having
consolidated
treatment
operations
rather
than
scattered
installations,

3.
Greater
potential
for
recycling
tritium
and
C­
14
from
a
few
commercial
generators,
rather
than
dozens
of
small
laboratory
treatment/
generators,
4.
Greater
reliability
from
having
dedicated,
rather
than
intermittent
hobby,
operators
for
complex
equipment,

5.
Low
potential
for
contaminant
release
to
the
environment
during
handling
and
treatment.

Rather
than
encourage
the
proliferation
of
small
treatment
facilities
that
only
address
part
of
the
problem,
we
suggest
that
generators
of
RCRA
mixed
wastes
use
the
existing
permitted
capacity.
ATG
can
treat
not
only
the
liquid
mixed
wastes,
but
also
the
solid
mixed
wastes
that
are
generated
during
the
handling
of
the
liquids.

ATG
recognizes
the
depth
of
frustration
generated
in
the
past
when
trying
to
identify
disposal
options
for
mixed
waste.
However,
ATG's
Richland
,
WA
facility
along
with
two
other
permitted
mixed
waste
facilities
in
the
United
States
provide
the
capacity
to
safely
process
the
wastes
being
proposed
for
exemption.

EPA
Response:
The
Agency
acknowledges
the
concerns
expressed
by
this
commenter.
However,
the
Agency
remains
committed
to
pursuing
this
innovative
pilot
project.
We
note
that
both
of
the
commenter's
concerns
are
directed
at
the
issue
of
whether
the
site­
specific
exclusion
finalized
in
this
rulemaking
should
be
adopted
on
a
national
basis
and
not
at
the
site­
specific
exclusion
itself.
Thus,
the
comments
are
not
relevant
to
the
current
rulemaking.
We
also
note
that
the
commenter
did
not
question
the
technical
performance
of
the
high­
temperature
catalytic
oxidizing
unit.

We
believe
addressing
commenter's
specific
concerns
over
national
application
of
today's
sitespecific
rule
would
be
premature
because
the
precise
parameters
of
such
a
rule
are
unknown.
Should,
however,
the
Agency
decide
to
pursue
developing
a
rule
to
expand
the
conditional
exclusion
approach
in
today's
rule
on
a
national
basis,
the
commenter
will
have
a
further
opportunity
to
raise
its
concerns
in
comments
to
the
Agency.
The
Agency
would
then
have
to
consider
and
respond
to
those
comments
before
issuing
that
final
rule.

Comment:
OMPP­
00034
This
is
in
response
to
the
above
referenced
Federal
Register
allowing
treatment
of
mixed
wastes
without
a
permit.
Perma­
Fix
Environmental
Services,
Inc.,
(
PESI)
operates
three
facilities
in
Tennessee
and
Florida
possessing
RCRA/
TSCA
permits
and
radioactive
materials
licenses
for
the
commercial
treatment
of
mixed
wastes.
PESI
is
generally
opposed
to
the
treatment
of
mixed
wastes
by
unlicensed,
and/
or
non­
permitted
facilities.
PESI
believes
that
authorization
to
allow
wastes
to
be
treated
on
a
one
time,
part
time
basis
as
outlined
in
this
rule,
is
unnecessary,
is
inconsistent
with
EPA's
charter
to
protect
the
general
public,
and
sets
a
serious
precedent.
More
specifically,
20
1.
By
definition,
this
rule­
making
reduces
treatment
standards
and
ignores
established
criteria
for
facilities
intending
to
perform
treatment
of
mixed
wastes.
Current
rules,
to
be
waved
by
this
action,
require
extensive
submittal
and
assurances
to
the
regulatory
agencies
that
strict
controls
and
qualified
personnel
will
be
in
place
to
assure
proper
handling
of
potentially
hazardous
materials.
In
other
words,
ignoring
the
current
rules
reduces
controls
and
represents
a
risk
to
the
workers.

2.
The
proposed
rule,
to
allow
unlicensed/
non­
permitted
facilities
to
treat
potentially
hazardous
materials,
may
result
in
uncontrolled
releases
off­
site.
Without
assurance
that
sufficient
controls
(
engineering
and
procedures)
are
in
place,
mistakes
can
result.
Historically,
these
types
of
incidences
have
eroded
the
public
confidence
in
an
industry
which,
unfortunately,
has
sustained
compound
restrictions
to
the
already
established
and
compliant
facilities.
These
more
severe
controls
thereby
reduce
the
industry's
ability
to
address
new
waste
forms
requiring
treatment.
In
other
words,
if
a
release
happens
under
this
rule,
the
public
could
lose
confidence
in
the
EPA
and
state,
erode
confidence
in
our
industry's
ability
to
control
these
materials
which
would
set
the
industry
back
years.

3.
The
proposed
rule
reduces
the
established
requirement
to
obtain
licenses
and
permits
for
treatment
of
mixed
waste
allowing
the
treatment
of
waste
at
facilities
that
are
not
licensed
or
permitted
for
such
activities.
PESI
has
invested
considerable
time
and
capital
to
established
three
properly
licensed/
permitted
facilities
for
treatment
of
mixed
wastes.
In
other
words,
we
are
concerned
that
reducing
established,
proven
standards
for
treatment
of
hazardous
wastes
greatly
devalues
the
existing
commercial
investment
thus
reducing
the
viability
of
the
commercial
business
sector
and
diminishes
the
development
of
additional
treatment
options
for
future
mixed
wastes.

4.
And,
it
is
hard
to
understand
how
the
benefit
of
relaxing
the
established
permitting
and
licensing
process
for
treatment
of
mixed
waste
offsets
the
risks.
The
USEP
A
and
the
states
have
spent
considerable
time
and
money
to
establish
methods
for
issuing
permits
and
licenses
to
businesses
and
generators
to
assure
the
safe
handling
and
processing
of
these
wastes.
Why
is
it
necessary
to
override
what
has
taken
years
to
develop?
If
the
pharmaceutical
industry
wishes
to
enter
the
waste
treatment
business,
processes
exist
for
them
to
obtain
permits
and
licenses.
This
is
especially
true,
when
there
are
existing
alternatives
available
to
the
generator
in
the
form
of
treatability
studies.
This
existing
regulations
allow
the
generator
to
develop
the
technology,
demonstrate
that
it
can
be
used
effectively
and
safely,
thus
assuring
all
parties
the
efficacious
use
of
the
treatment.

5.
And
finally,
the
precedenting
impact
of
this
decision
is
unknown.
While
this
decision
on
the
surface
may
appear
forward­
looking
to
some,
once
allowed
for
one,
what
criteria
will
be
used
to
prevent
the
denial
of
future
requests?
The
USEPA
could
sustain
extreme
criticism
from
the
public
and
the
generators
for
allowing
such
a
precedenting
decision.
In
other
words,
the
USEPA
is
taking
undo
risks
with
the
worker
protection
and
the
environment
while
trying
to
appear
accommodating
to
the
industry.
This,
unfortunately,
creates
unknown
precedences
that
could
21
create
major
unforeseen
problems.

In
summary,
there
is
no
reason
to
change
the
current
permit/
licensing
processes
for
the
treatment
of
mixed
waste.
Sufficient
procedures
exist
to
allow
generators
to
obtain
proper
approvals.
Furthermore,
there
exist
fully
authorized
commercial
facilities
to
treat
these
wastes.

EPA
Response:
This
commenter
expressed
a
general
opposition
to
the
"
treatment
of
mixed
wastes
by
unlicensed,
and/
or
non­
permitted
facilities"
and
believes
that
"
authorization
to
allow
wastes
to
be
treated
on
a
one
time,
part
time
basis
as
outlined
in
this
rule,
is
unnecessary,
is
inconsistent
with
EPA's
charter
to
protect
the
general
public,
and
sets
a
serious
precedent."
EPA
disagrees
with
the
commenter's
views.
We
believe
that
it
is
appropriate
in
this
rule,
which
implements
a
pilot
project
under
the
Project
XL
program,
to
explore
an
innovative
treatment
process
for
small
volumes
of
mixed
waste
in
light
of
the
information
presented
by
Ortho­
McNeil
Pharmaceutical,
Inc.(
OMP).
OMP
asserts
that
RCRA
Subtitle
C
controls
serve
as
a
major
disincentive
to
the
environmentally
protective
on­
site
treatment
of
small
volumes
of
mixed
waste
such
as
generated
by
the
pharmaceutical
industry
in
the
research
and
development
of
new
pharmaceuticals.
We
also
believe
that
the
on­
site
treatment
of
OMP's
small
volumes
of
mixed
waste
will
be
done
in
a
manner
protective
of
human
health
and
the
environment.
The
on­
site
treatment
of
OMP's
mixed
wastes
has
already
been
extensively
tested
under
a
"
treatability
study"
exemption
provided
in
40
CFR
2614(
f).
In
addition,
the
conditions
that
the
rule
imposes
on
the
exclusion
will
assure
that
the
treatment
process
will
continue
to
be
protective
and
will
provide
the
Agency
with
the
data
necesssary
to
determine
wether
to
adopt
the
exclusion
on
a
national
basis.

This
commenter
also
expressed
several
more
specific
remarks
in
opposition
to
the
rule.
These
are
addressed
below.

1.
The
rule
"
reduces
treatment
standards
and
ignores
established
criteria
for
facilities
intending
to
perform
treatment
of
mixed
wastes"
.
.
.
ignoring
the
current
rules
reduces
controls
and
represents
a
risk
to
the
workers."
(
Emphasis
in
original
comment).

EPA
disagrees
that
the
rule
reduces
treatment
standards.
The
exclusion
is
conditioned
upon
OMP
treating
the
waste
using
the
high
temperature
catalytic
oxidation
unit
which
has
consistently
destroyed
the
organic
component
of
the
waste
(
routinely
achieving
destruction
and
removal
efficiencies
(
DRE)
of
99.999%
to
99.99999%)
beyond
the
LDR
treatment
standard.
EPA
also
disagrees
that
the
rule
represents
an
increased
risk
to
workers.
The
management
of
the
mixed
waste
remains
subject
to
AEA
requirements.
As
explained
in
the
recently
promulgated
Mixed
Waste
rule
(
66
FR
27217
May
16,
2001),
EPA
generally
believes
that
given
NRC
regulatory
controls,
protection
of
human
health
and
the
environment
from
chemical
risks
would
not
be
compromised
by
deferral
to
NRC's
management
requirements.
EPA
specifically
believes
that
given
the
circumstances
such
as
a
professionally­
trained
lab
staff
["
sophisticated
level
of
expertise
of
the
technicians
that
work
in
the
lab"]
is
included
in
a
list
of
reasons
why
EPA
thinks
an
NRC
license
is
sufficient
to
protect
HHE
in
section
III
C,
and
a
small
volume
of
mixed
waste
(
no
more
than
50
liters/
year)
treated
within
an
NRC­
licensed
laboratory
that
the
exclusion
will
not
22
result
in
any
increased
risk
to
the
laboratory
workers.
For
a
more
complete
technical
description
of
the
unit,
operations
parameters
an
analytical
methodology,
see
"
A
Prototype
High­
Temperature
Catalytic
Oxidation
Process
For
Mixed
Waste
In
A
Pharmaceutical
Research
Laboratory,"
available
in
the
docket
for
today's
rule.

2.
According
to
the
commenter,
the
rule
to
"
allow
unlicensed
/
non­
permitted
facilities
to
treat
potentially
hazardous
materials,
may
result
in
uncontrolled
releases
off­
site."
The
commenter
then
states
a
concern
that
if
an
uncontrolled
release
were
to
occur
under
the
conditional
exclusion,
then
public
confidence
in
the
industry
would
be
in
jeopardy
which
could
lead
to
public
pressure
for
even
more
stringent
regulatory
control
over
the
waste
treatment
industry.
EPA
does
not
share
the
commenters
concerns.
First,
today's
rule
excludes
the
mixed
waste
from
RCRA
hazardous
waste
regulation
from
only
one
facility
 
OMP's
Spring
House,
Pennsylvania
facility.
Second,
even
though
the
facility
does
not
have
to
obtain
a
RCRA
permit,
the
facility
is
NRC­
licensed
and
subject
to
NRC
regulation
including
requirements
restricting
off­
site
releases
of
mixed
waste.
Third,
by
its
terms
the
rule
only
excludes
from
regulation
up
to
50
liters/
year.
Finally,
throughout
the
development
of
this
XL
project
OMP
has
cultivated
local
community
and
local
environmental
group
involvement
to
ensure
that
the
local
community
understands
the
nature
and
scope
of
today's
rule.
Based
on
these
considerations,
EPA
believes
that
the
rule
is
unlikely
to
result
in
an
uncontrolled
release
of
hazardous
waste
that
would
cause
the
kind
of
public
backlash
that
the
commenter
envisions.

3.
The
proposed
rule
"
reduces
the
established
requirement
to
obtain
licenses
and
permits
for
treatment
of
mixed
waste
.
.
.[
the
commenter]
has
invested
considerable
time
and
capital
to
established
[
sic]
three
properly
licensed/
permitted
facilities
for
treatment
of
mixed
wastes.
Hence,
according
to
the
commenter
the
proposed
rule
would
"
devalue
the
existing
commercial
investment
thus
reducing
the
viability
of
the
commercial
business
sector
and
diminishes
the
development
of
additional
treatment
options
for
future
mixed
wastes."
(
Emphasis
in
original
comment).

The
Agency
acknowledges
the
concerns
expressed
by
this
commenter.
However,
the
Agency
remains
committed
to
pursuing
this
innovative
pilot
project.
We
note
that
the
commenter's
concern
is
directed
at
the
issue
of
whether
the
site­
specific
exclusion
finalized
in
this
rulemaking
should
be
adopted
on
a
national
basis
and
not
at
the
site­
specific
exclusion
itself.
Thus,
the
comment
is
not
relevant
to
the
current
rulemaking.

We
believe
addressing
commenter's
specific
concern
over
national
application
of
today's
site­
specific
rule
would
be
premature
because
the
parameters
of
such
a
rule
are
unknown.
Should,
however,
the
Agency
decide
to
pursue
developing
a
rule
to
expand
the
conditional
exclusion
approach
in
today's
rule
on
a
national
basis,
the
commenter
will
have
a
further
opportunity
to
raise
its
concerns
in
comments
to
the
Agency.
The
Agency
would
then
have
to
consider
and
respond
to
those
comments
before
issuing
that
final
rule.

4.
The
commenter
states
that
it
is
hard
to
understand
how
the
benefit
of
relaxing
the
established
23
permitting
and
licensing
process
for
treatment
of
mixed
wastes
offsets
the
risks.
The
commenter
further
states
that
if
the
pharmaceutical
industry
wishes
to
enter
the
waste
treatment
business,
processes
exist
for
them
to
obtain
permits
and
licenses.
The
commenter
questions
why
it
is
necessary
to
issue
today's
rule
when
"
existing
regulations
allow
the
generator
to
develop
the
technology,
demonstrate
that
it
can
be
used
effectively
and
safely,
hus
assuring
all
parties
the
efficacious
use
of
the
treatment."

EPA
disagrees
with
the
commenter's
position
that
the
risks
posed
by
today's
rule
out
weigh
its
benefits.
As
explained
in
the
preamble
to
the
final
rule,
the
benefits
of
granting
this
sitespecific
conditional
exclusion
is
to
test
in
a
tightly
controlled
environment
whether
NRC
regulation
alone
provides
sufficient
protection
for
human
health
and
the
environment
for
the
thermal
treatment
of
small
volumes
of
low­
level
mixed
wastes.
If,
after
a
period
of
evaluation,
the
Agency
determines
that
such
treatment
of
small
volumes
of
mixed
wastes
generated
and
treated
in
a
pharmaceutical
research
laboratory
do
not
require
RCRA
hazardous
waste
regulation
to
ensure
protection
of
human
health
an
the
environment,
then
EPA
may
adopt
the
approach
on
a
national
basis.
Deferring
regulation
of
this
waste
stream
to
NRC
would
reduce
waste
management
costs
of
pharmaceutical
research
and
development
activities,
thereby
leaving
more
money
available
for
actual
research
and
development
off
pharmaceuticals.

5.
Finally,
the
commenter
expresses
concern
that
the
precedential
impact
of
today's
rule
is
unknown
which
could
create
"
major
unforseen
problems."
The
commenter
does
not
offer
any
examples
of
the
potential
major
problems.
In
any
event,
EPA
does
not
share
the
commenter's
concerns.
Today's
rule
is
being
issued
as
part
of
Project
XL
which,
as
explained
in
the
preamble
to
the
proposal,
is
a
program
"
intended
to
encourage
EPA
to
experiment
with
potentially
promising
regulatory
approaches,
both
to
assess
whether
they
provide
benefits
at
the
specific
facility
affected,
and
whether
they
should
be
considered
for
wider
application."
66
FR
38397
(
July
24,
2001).
The
preamble
to
the
proposal
also
addressed
the
issue
of
the
precedential
impact
of
an
XL
rule.
The
preamble
states:

Adoption
of
such
alternative
approaches
or
interpretations
in
the
context
of
a
given
XL
project
does
not,
however,
signal
EPA's
willingness
to
adopt
that
interpretation
as
a
general
matter,
or
even
in
the
context
of
other
XL
projects.
It
would
be
inconsistent
with
the
forward­
looking
nature
of
these
pilot
projects
to
adopt
such
innovative
approaches
prematurely
on
a
widespread
basis
without
first
determining
whether
they
are
viable
in
practice
and
successful
in
the
particular
projects
that
embody
them.
Furthermore,
as
EPA
indicated
in
announcing
the
XL
program,
EPA
expects
to
adopt
only
a
limited
number
of
carefully
selected
projects.
These
pilot
projects
are
not
intended
to
be
a
means
for
piecemeal
revision
of
entire
programs.
Depending
on
the
results
in
these
projects,
EPA
may
or
may
not
be
willing
to
consider
adopting
the
alternative
interpretation
again,
either
generally
or
for
other
specific
facilities.
Id.
