[Senate Hearing 112-4]
[From the U.S. Government Publishing Office]
S. Hrg. 112-4
THE AMERICAN MEDICAL ISOTOPES
PRODUCTION ACT
=======================================================================
HEARING
before the
COMMITTEE ON
ENERGY AND NATURAL RESOURCES
UNITED STATES SENATE
ONE HUNDRED TWELFTH CONGRESS
FIRST SESSION
TO
RECEIVE TESTIMONY ON S. 99, THE AMERICAN MEDICAL ISOTOPES PRODUCTION
ACT OF 2011
__________
FEBRUARY 1, 2011
Printed for the use of the
Committee on Energy and Natural Resources
----------
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COMMITTEE ON ENERGY AND NATURAL RESOURCES
JEFF BINGAMAN, New Mexico, Chairman
RON WYDEN, Oregon LISA MURKOWSKI, Alaska
TIM JOHNSON, South Dakota RICHARD BURR, North Carolina
MARY L. LANDRIEU, Louisiana JOHN BARRASSO, Wyoming
MARIA CANTWELL, Washington JAMES E. RISCH, Idaho
BERNARD SANDERS, Vermont MIKE LEE, Utah
DEBBIE STABENOW, Michigan RAND PAUL, Kentucky
MARK UDALL, Colorado DANIEL COATS, Indiana
JEANNE SHAHEEN, New Hampshire ROB PORTMAN, Ohio
AL FRANKEN, Minnesota JOHN HOEVEN, North Dakota
JOE MANCHIN, III, West Virginia BOB CORKER, Tennessee
CHRISTOPHER A. COONS, Delaware
Robert M. Simon, Staff Director
Sam E. Fowler, Chief Counsel
McKie Campbell, Republican Staff Director
Karen K. Billups, Republican Chief Counsel
C O N T E N T S
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STATEMENTS
Page
Bingaman, Hon. Jeff, U.S. Senator From Mexico.................... 1
Brown, Roy W., Senior Director, Federal Affairs, Council on
Radionuclides and Radiopharmaceuticals......................... 7
Doane, Margaret M., Director, Office of International Programs,
Nuclear Regulatory Commission.................................. 13
Murkowski, Hon. Lisa, U.S. Senator From Alaska................... 2
Staples, Parrish, Ph.D., Director, Office of European and African
Threat Reduction, Global Threat Reduction Initiative, Defense
Nuclear Nonproliferation, National Nuclear Security
Administration, Department of Energy........................... 3
APPENDIXES
Appendix I
Responses to additional questions................................ 25
THE AMERICAN MEDICAL ISOTOPES PRODUCTION ACT
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TUESDAY, FEBRUARY 1, 2011
U.S. Senate,
Committee on Energy and Natural Resources,
Washington, DC.
The committee met, pursuant to notice, 9:59 a.m. in room
SD-366, Dirksen Senate Office Building, Hon. Jeff Bingaman,
chairman, presiding.
OPENING STATEMENT OF HON. JEFF BINGAMAN, U.S. SENATOR FROM
MEXICO
The Chairman. Why don't we get started. Thank you all for
being here. This is a hearing of the Senate Energy and Natural
Resources Committee. Let me first, before we get started,
welcome Senator Manchin, who has just joined our committee. As
other newly assigned members come to the committee, we will
certainly welcome them as well. But we'll have our first sort
of organizing meeting probably in a week or 2 to discuss
committee assignments and all of that.
Today's hearing is on S. 99. That is the American Medical
Isotopes Act of 2011. This bill is essentially the same bill
that was reported out of this committee last Congress by
unanimous consent, except that the program authorization has
been lowered by $20 million to account for the fact that we are
now in fiscal year 2011.
The purpose of the legislation is to develop a reliable
domestic supply of Molybdenum-99, which is used for 18 million,
or 85 percent, of the medical isotope procedures performed
annually in the United States. We currently have no domestic
supply of this isotope and we rely on aging reactors in Canada
and Europe to produce it. For the first time, the reactors in
Canada and Europe were shut down last July and August for
maintenance. That resulted in days when you could not get a
Molybdenum-99 procedure.
This bill will correct the problem by authorizing the
Department of Energy to work with U.S. companies to produce a
reliable domestic supply of Molybdenum-99 in order to avoid a
future shortage. The bill also proposes a 14-year phaseout of
exporting of highly enriched uranium, which is used to produce
these isotopes.
It seems to me that since we're now negotiating with Iran
to supply their medical isotope reactor with low enriched fuel,
we ought to lead by example and phaseout the export of the
weapons-grade uranium to produce these isotopes. The technology
exists to produce Molybdenum-99 from low enriched uranium.
South Africa and Australia are currently doing so. This bill
authorizes the Department of Energy to enter into cooperative
agreements and for U.S. companies to do so as well.
I want to thank the witnesses who are appearing today. Two
of the witnesses testified on this bill in the last Congress.
Dr. Staples, Mr. Brown, I thank you for appearing again today.
Ms. Doane is the technical expert from the Nuclear Regulatory
Commission, which has submitted formal written comments on the
bill. She will not have an opening statement today, but will be
at the witness table to answer any questions on how the Nuclear
Regulatory Commission manages the export of special nuclear
materials such as the highly enriched uranium used to produce
Molybdenum-99.
Let me call on Senator Murkowski for any statement she'd
like to make.
STATEMENT OF HON. LISA MURKOWSKI, U.S. SENATOR
FROM ALASKA
Senator Murkowski. Thank you, Mr. Chairman. It's good to be
back at the committee.
I would also like to welcome our new members on your side,
Senator Franken and Senator Manchin. I think you will find this
is a committee where we jump into the interesting, complex,
sometimes contentious issues with great relish, but do so with
a degree of civility, honesty, and attention to the work that
yields good product. I think you'll enjoy the committee.
We have a handful of new members joining on our side of the
aisle. They are Senator Lee, Senator Paul, Senator Coats,
Senator Portman, Senator Hoeven. We have a good group of
members.
As you point out, Mr. Chairman, our committee has had an
opportunity to review the issue of the supply of nuclear
medical isotopes, but in fairness to our new members, it is
important that we do some reruns. We'll be seeing some of these
as we proceed in the early part of this year, but very
important issues.
For those of you that are joining us here today, the
chairman and I were discussing the new lighting. Apparently,
I'm told that we are the first committee room in the Congress
to be fully installed with the new LED lights. Of course we
like them, because they are more energy efficient, but they do
cast a different pall on the rest of you out there.
I do want to thank you for scheduling this hearing.
The Chairman. Next we're going to see if we can get some
heat in the room--our next renovation.
[Laughter.]
Senator Murkowski. One step at a time, sir.
You have given some good background on the issue relating
to our domestic supply of nuclear medical isotopes, the fact
that we have not had here in this country a domestic supply
since 1989. We saw the shortages play out in 2009 and 2010
within our medical communities. I understand that, while the
supply currently is meeting a growing demand, the stability and
the long-term viability of that supply is in question.
The bill before us seeks to help promote the domestic
production of Mo-99 to meet our country's needs. It's been just
over a year that we had the hearing on this subject. I look
forward to hearing from you, Dr. Staples and Mr. Brown, the
progress that has been made thus far in moving toward a more
domestic supply; and also interested in hearing what changes
you believe may be needed to the legislation that we discussed
last year.
With that, I look forward to the comments.
The Chairman. All right. Let me also join in welcoming
Senator Franken. We're glad he's on the committee and look
forward to his active participation.
Dr. Parrish Staples is the Director of the Office of
European and African Threat Reduction with the Global Threat
Reduction Initiative, Defense Nuclear Nonproliferation, at the
National Nuclear Security Administration in the Department of
Energy. Mr. Roy Brown is the Senior Director of Federal Affairs
with the Council on Radionuclides and Radiopharmaceuticals. We
appreciate both of them being here.
Dr. Staples, why don't you start and then Mr. Brown, and
then we'll have some questions.
STATEMENT OF PARRISH STAPLES, PH.D., DIRECTOR, OFFICE OF
EUROPEAN AND AFRICAN THREAT REDUCTION, GLOBAL THREAT REDUCTION
INITIATIVE, DEFENSE NUCLEAR NONPROLIFERATION, NATIONAL NUCLEAR
SECURITY ADMINISTRATION, DEPARTMENT OF ENERGY
Mr. Staples. Thank you, Chairman Bingaman, Ranking Member
Murkowski, and the other committee members, for the opportunity
to testify about the National Nuclear Security Administration's
support for accelerating the development of a domestic
commercial supply of Molybdenum-99 without using highly
enriched uranium. Today I will update you on the testimony
provided to this committee in December 2009: first, the
nonproliferation and medical benefits of S. 99, the American
Medical Isotopes Production Act of 2011; second, NNSA's
progress to accelerate the establishment of a non-HEU-based
domestic commercial supply of Mo-99; and last, the changing
global market conditions that could undermine our efforts for
reliable domestic production of non-HEU-based Mo-99.
Currently the United States depends entirely on foreign
producers for all of our Mo-99. Of the world's major
international suppliers, Canada, The Netherlands, and Belgium
use HEU targets to produce this vital medical isotope. Only
South Africa, which partnered with NNSA to convert its HEU-
fueled reactors to low-enriched uranium fuel, has begun LEU-
based Mo-99 production.
NNSA frequently meets with the existing major global
producers as part of its nuclear nonproliferation agenda to
promote the development of a long-term reliable supply of Mo-99
using LEU. World leaders at the 2010 Nuclear Security Summit
and other fora underscored the need to minimize and, where
possible, eliminate the use of HEU due to the grave threats
posed by excess nuclear materials and the possible acquisition
of such materials by terrorists or rogue States.
As has been the case in 2009-2010, global shortages can
occur with any change in the production schedule of the major
producers. Under the leadership of the Office of Science and
Technology Policy of the Executive Office of the President, an
inter-agency working group which includes NNSA and many others
are pursuing actions to minimize these near-term shortages.
The 2009 National Academies report confirmed that
production of Mo-99 is both technically and economically
feasible. As a result, NNSA is demonstrating the feasibility of
non-HEU-based production by working with four commercial
entities to develop technology pathways to produce adequate
quantities of Mo-99 for the United States. These include LEU
solution reactor, neutron capture, and accelerator-based
technologies. The strategy is to move away from reliance on a
sole technology and a limited number of facilities, as is the
case with the global Mo-99 market today.
Now, despite the good progress, challenges remain that
could obstruct the successful and accelerated establishment of
a domestic supply of Mo-99. Just last week I represented the
United States at the High-Level Group on Medical Radioisotopes
hosted by the Organization for Economic Cooperation and
Development's Nuclear Energy Agency. I would like to highlight
the following main points of that discussion:
First, there is recognition that the current industry has
failed and that both commercial industry and governments cannot
become complacent in their actions to reestablish a reliable
supply of Mo-99 now that the Canadian and Dutch reactors are
once again operational. A primary issue is that the major
global producers have been, and generally continue to be,
heavily subsidized by their governments. Such subsidies put at
risk the economic viability of companies starting up high, tech
capital-intensive businesses to produce non-HEU-based Mo-99.
To provide a level playing field for U.S. companies, meet
our nonproliferation goals, and build a non-HEU-based industry
for Mo-99, there must be a concerted global commitment that all
new or expanded long-term Mo-99 production be undertaken
without HEU. Very importantly, we must achieve full cost
recovery across the entire global commercial industry. Any
foreign government subsidy of HEU-based production puts the
objectives of this legislation at risk.
We also have significant concerns about the scope, cost,
and other implications of section 2[c], the Uranium Lease-
Takeback provision. In addition, that proposed sub-program
could risk lengthening the timeframe to Mo-99 production if the
schedule for implementing the proposed Uranium Lease and
Takeback sub-program were to have any linkage to the expected
production schedule of the commercial projects to produce Mo-
99.
NNSA will use its existing well-established program
management and procurement oversight tools to ensure that the
innovative non-HEU-based technologies it supports are developed
on schedule and that cost-shared funds are properly applied so
that Mo-99 is delivered to the U.S. market on time and within
anticipated costs. NNSA will also closely coordinate with the
Nuclear Regulatory Commission and the Food and Drug
Administration on reliability issues associated with the
commercial use of these technologies.
To summarize, the Department of Energy and NNSA believe
that overall this legislation will be helpful in providing
public visibility to critical nonproliferation goals and to
equally critical medical needs. With clear commitment and
sustained support, we can secure our citizens' health needs as
well as their national security.
Thank you, Senator Bingaman, Ranking Member Murkowski, and
other members of the committee for your continued leadership in
supporting this legislation and we look forward to working with
you to address any issues raised here today. I appreciate the
opportunity to testify and I'm ready to answer your questions.
[The prepared statement of Mr. Staples follows:]
Prepared Statement of Parrish Staples, Ph.D., Director, Office of
European and African Threat Reduction, Global Threat Reduction
Initiative, Defense Nuclear Nonproliferation, National Nuclear Security
Administration, Department of Energy
Chairman Bingaman, Ranking Member Murkowski, and Committee Members,
thank you for the opportunity to testify about the National Nuclear
Security Administration's (NNSA's) support for accelerating development
of a domestic commercial supply of Molybdenum-99 (Mo-99) without using
highly enriched uranium (HEU). This effort is part of our larger global
nonproliferation program to minimize and, where possible, eliminate the
use of HEU in civilian nuclear applications, including in the
production of medical radioisotopes. My testimony will update you on
testimony provided to this committee in December 2009 about (1) the
nonproliferation and medical benefits of S. 99, the American Medical
Isotopes Production Act of 2011; (2) the NNSA's progress to accelerate
the establishment of a non-HEU based domestic commercial supply of Mo-
99; and (3) changing global market conditions that could undermine our
efforts for a reliable domestic production of non-HEU-based Mo-99.
Mo-99 is the parent isotope of Technetium-99m, which is used in
approximately 50,000 diagnostic medical procedures every day in the
United States. It has a very short half life and therefore must be
produced on a continuous basis to meet the needs of the medical
community. Any interruptions in production can place patients at risk
if diagnostic tests cannot be performed.
Currently, the United States depends entirely on foreign producers
for all of its Mo-99. Of the major international suppliers of
commercial Mo-99, Canada, the Netherlands, and Belgium use HEU targets
to produce this vital medical isotope. Only South Africa, which
partnered with NNSA to convert its HEU reactor to low enriched uranium
(LEU) fuel, has begun LEU-based Mo-99 production.
Mo-99 production processes based on HEU utilize nuclear material
enriched to the same degree as nuclear material used to produce nuclear
weapons and improvised nuclear devices. World leaders at the 2010
Nuclear Security Summit and other fora underscored the need to minimize
and, where possible, eliminate the use of HEU due to the grave threats
posed by excess nuclear materials and the possible acquisition of such
materials by terrorists or rogue states. New technical advances in Mo-
99 production processes, many of which have been supported by the U.S.
Department of Energy and NNSA working closely with industry and our
national laboratories, are demonstrating that HEU is no longer
required. S. 99, the American Medical Isotopes Production Act of 2011
will encourage Mo-99 suppliers worldwide not to use HEU and to develop
a reliable supply of Mo-99 for the U.S. medical community. Provisions
of this legislation, in particular Section 5, are aligned with the
NNSA's nonproliferation mission to assist in the conversion of research
reactors and isotope production facilities worldwide from the use of
HEU to LEU, and to establish a reliable supply of Mo-99 produced
without the use of HEU in the United States.
Furthermore, the HEU-free, U.S.-based Mo-99 production encouraged
by the American Medical Isotopes Production Act of 2011 would serve as
an example for eliminating HEU in the global medical isotope business.
The proposed legislation will promote the reliable supply of Mo-99 to
hospitals throughout our country and will ultimately ensure the level
of patient care that our citizens require in a way that is consistent
with our nuclear nonproliferation goals.
As has been the case in 2009-2010, global Mo-99 shortages can occur
with any change in the production schedules of the major producers.
Unforeseen shutdowns due to technical problems or scheduled maintenance
of the aging reactors currently producing Mo-99 can threaten the
fragile supply chain for the much needed medical isotopes. Under the
leadership of the Office of Science and Technology Policy of the
Executive Office of the President, an Interagency working group, which
includes NNSA and other Department of Energy offices, is pursuing the
following actions: (1) investigating options to focus on near-term
efforts to increase the supply to the U.S. during periods when the
major suppliers will be out of operation; (2) coordinating efforts to
maximize the success of the commercial sector to develop new longer-
term production capabilities for the U.S. medical community; and (3)
working with representatives of the medical community to ensure
communication about the timing of scheduled maintenance to more
efficiently manage use of available Mo-99 supplies.
NNSA frequently meets with the existing major global Mo-99
producers as part of its nuclear nonproliferation agenda to promote the
development of a long-term reliable supply of Mo-99 using LEU. NNSA's
programs can also assist other countries with conversion, where
possible. For example, with NNSA's support, the South African Nuclear
Energy Corporation (Necsa) became the first major supplier to produce
large-scale quantities of LEU-based Mo-99, and completed its first
shipment of FDA-approved, LEU-based Mo-99 to the United States in
December 2010. Necsa's achievement to produce large-scale quantities of
LEU-based Mo-99 is an important nonproliferation advance as it
demonstrates the technical viability of producing Mo-99 consistent with
international commitments to minimize and eliminate the use of HEU in
isotope production. With appropriate Congressional support, the long-
term goal of steady state production from LEU could be achieved
globally, and could thus provide a complementary, consistent supply of
the medical isotope to health care providers.
The 2009 National Academies report confirmed that production of Mo-
99 is both technically and economically feasible, and as a result, NNSA
is demonstrating the feasibility of non-HEU based Mo-99 production by
working with four commercial entities to develop technology pathways to
produce adequate quantities of Mo-99 for the United States. These
include: LEU solution reactor technology; neutron capture technology;
and accelerator technology. The strategy is to move away from reliance
on a sole technology and a limited number of facilities, as is the case
with the global Mo-99 market today. The goal is for each technology to
be commercially successful, and therefore NNSA's approach is technology
neutral. NNSA also makes available to these commercial partners the
technical expertise of the U.S. national laboratories gained from their
many years of work to develop non-HEU based Mo-99 production
technologies. We share the goals of this bill and look forward to
working with you to ensure the accomplishment of nuclear threat
reduction activities and the development of a reliable supply of
medical isotopes to the public, while ensuring greater Presidential
flexibility.
Despite the good progress, challenges remain that could obstruct
the successful and accelerated establishment of a domestic supply of
Mo-99. First, the major global producers have been and continue to be
heavily subsidized by their governments. Such subsidies put at risk the
economic viability of U.S. companies starting up high-tech, capital
intensive businesses to produce non-HEU based Mo-99. A 2010 independent
economic study by the Organization for Economic Cooperation and
Development's Nuclear Energy Agency entitled ``An Economic Study of the
Molybdenum-99 Supply Chain'', underscores this issue by citing that
long-term subsidies have damaged industry's attempts to enter the
global Mo-99 market. To provide a level playing field for U.S.
companies, meet nonproliferation goals, and build a non-HEU based
industry for Mo-99, there must be a concerted global commitment that
all new or expanded long-term Mo-99 production be undertaken without
HEU. Very importantly, we must achieve full cost recovery across the
entire global commercial industry. Any foreign government subsidy of
HEU-based production puts the objectives of this legislation at risk.
We have significant concerns about the scope, costs, other
implications of Section 2(c), the ``Uranium Lease and Take Back''
provision. In addition, the proposed program could risk lengthening the
timeframe to Mo-99 production if the schedule of implementing the
proposed ``Uranium Lease and Take Back'' subprogram were to have any
linkage to the expected production schedule of the commercial projects
to produce Mo-99.
NNSA will use its existing, well-established program management and
procurement oversight tools to ensure that the innovative non-HEU based
technologies it supports are developed on schedule and that cost-shared
funds are properly applied so that Mo-99 is delivered to the U.S.
market on time and within anticipated costs. NNSA will also coordinate
closely with the Nuclear Regulatory Commission and the Food and Drug
Administration on regulatory issues associated with the commercial use
of new technology.
To summarize, the Department of Energy and NNSA believe that,
overall, this legislation will be helpful in providing public
visibility to critical nonproliferation goals and to equally critical
medical needs. With clear commitment and sustained support, we can
secure our citizens' health needs as well as their national security. I
thank Senator Bingaman, Ranking Member Murkowski, and Members of the
Committee for your continued leadership in supporting this legislation
and we look forward to working with you to address any issues raised
here today. I appreciate the opportunity to testify and am ready to
answer your questions.
The Chairman. Thank you very much.
Mr. Brown.
STATEMENT OF ROY W. BROWN, SENIOR DIRECTOR, FEDERAL AFFAIRS,
COUNCIL ON RADIONUCLIDES AND RADIOPHARMACEUTICALS
Mr. Brown. Good morning, Mr. Chairman, Ms. Murkowski,
members of the committee, and staff. My name is Roy Brown and
I'm Senior Director of Federal Affairs for the Council on
Radionuclides and Radiopharmaceuticals, or CORAR. I'm
representing CORAR here today to testify on behalf of the
American Medical Isotopes Act of 2011 and to answer questions
from the committee.
CORAR testified before both the Senate and House during the
last Congress in support of the proposed predecessor
legislation, H.R. 3276. Thus, we support S. 99 and the
provisions contained in the legislation. We believe this
legislation will provide critical funding, assurance of, and
the regulatory framework necessary to establish the reliable
medical isotope production capabilities in the U.S. This
legislation is an important step toward a reliable source of
medical isotopes for our patients and will contribute to
enhancing supply well into the future.
In U.S. hospitals and clinics, Technetium-99m, produced
from Mo-99, is administered to more than 40,000 patients each
day in the detection and staging of cancer, detection of heart
disease, detection of thyroid disease, study of the brain and
kidney function, and imaging of stress fractures. Thousands of
other nuclear medicine procedures are conducted every day in
the U.S. with radionuclides, such as I-131, I-125, You-90 and
Xenon-133, in the diagnosis and treatment of diseases. These
other isotopes are made as a byproduct of the Mo-99 production
process. Nuclear medicine procedures not only improve the
quality of life, but they save lives. A self-sustaining
domestic supply of radionuclides used in nuclear medicine would
ensure our patients receive the necessary care while reducing
our health care costs.
As a supporter of S. 99, CORAR would like to highlight four
specific issues for the committee's consideration to ensure
that the bill will accomplish its goals and serve the needs of
U.S. patients. First, section 2[c] of the legislation contains
an important provision requiring DOE to accept waste created by
the production of medical isotopes from the DOE-leased uranium.
This provision is important because currently there's no
disposal pathway available in the U.S. for the types of
radioactive wastes that will be generated in the production of
Mo-99 and these other medical isotopes.
It is critically important to the objective of this
legislation that DOE accepts such radioactive waste at
reasonable prices. These prices should be similar to what we
would expect to pay for commercial disposal if commercial
disposal waste facilities were available. This will help assure
new medical isotope production facilities can be built and
operated effectively.
Second, the NRC has a comprehensive regulatory framework
for the protection of the environment, workers, and the public.
Any new reactor or production facility receiving funding under
this legislation will be licensed by the NRC or equivalent
Agreement State agency. Various aspects and operations of these
facilities will also be regulated by the Food and Drug
Administration, the Department of Transportation, the
Environmental Protection Agency, as well as State and local
regulatory agencies.
We are concerned that acceptance of money from DOE for the
development of medical isotopes for the development of medical
isotope capability under this legislation may trigger
duplicative nuclear--I'm sorry--National Environmental Policy
Act, or NEPA, reviews. With these various levels of regulatory
oversight, we do not believe NEPA will offer any more
protection of the environment than already provided by NRC,
FDA, DOT, and others. The triggering of NEPA by these new
production facilities could seriously delay the project, which
would not be consistent with the desired schedule and would
significantly increase its costs.
The NRC licensing process required for these new facilities
is actually a NEPA process. As such, we would like to see NRC
as the lead agency in the review to avoid a duplicative
regulatory process which would be created by both NRC and EPA
conducting their own NEPA review. If the NRC took the lead on
this review, these new facilities would be required to pass a
rigorous environmental NEPA review by NRC, while still allowing
them to meet the time schedule necessary to meet patient
demand.
Several groups are working on the development of new types
of isotope production reactors or have plans to utilize
existing reactors for production of medical isotopes. Some of
these reactors may fall into a licensing gap at NRC. These new
reactors do not meet the definition of a research reactor under
the language in section 4 of the Atomic Energy Act due to their
production focus and lack of research being conducted there.
These types of reactors also do not have the inherent risk
or security concerns of large commercial nuclear power reactors
which are licensed under section 103 of the Atomic Energy Act.
CORAR would like to see S. 99 either revise section 104 of the
Atomic Energy Act to recognize these types of reactors for the
production of medical isotopes or direct the NRC to permit the
licensing of these reactors under section 104 of the Atomic
Energy Act. If assistance of this type could be included in the
legislation, it would help expedite the licensing of these new
reactors and bring these new sources of Mo-99 to market more
quickly.
Four, CORAR is aware of several promising efforts to
develop new medical isotope production technologies. NNSA at
DOE has already awarded cooperative grants to a number of
projects based on different technological approaches. Given
this legislation's intent to broadly serve American patients,
future funding should be directed to the project or projects
which stand the best chance of producing commercially
meaningful quantities of medical isotopes within the timeframe
envisioned in this legislation.
We also would like to see the process by which DOE awards
development money fully vetted through a regulatory--through a
rulemaking or some other process where our industry or other
interested parties can review and comment on DOE's proposed
evaluation criteria and decisionmaking process for such
projects.
I'd like to thank you for the opportunity to testify here
today. CORAR is supportive of this legislation and hopes to
continue to work with the committee and staff to ensure both a
swift and long-term solution to the medical isotope supply
crisis for the benefit of the American patients.
I'd be happy to answer any questions the committee may
have. Thank you.
[The prepared statement of Mr. Brown follows:]
Prepared Statement of Roy W. Brown, Senior Director, Federal Affairs,
Council on Radionuclides and Radiopharmaceuticals,
Good morning Mr. Chairman, Ms. Murkowski, members of the Committee
and staff.
My name is Roy Brown and I am the Senior Director of Federal
Affairs for the Council on Radionuclides & Radiopharmaceuticals, or
CORAR\1\. I am representing CORAR here today to testify on behalf of
the American Medical Isotopes Act of 2011 and to answer questions from
the Committee.
---------------------------------------------------------------------------
\1\ The Council on Radionuclides and Radiopharmaceuticals, Inc.
(CORAR) is comprised of companies which produce products utilizing many
different radionuclides. CORAR members include the major manufacturers
and distributors of radiopharmaceuticals, radioactive sources, and
research radionuclides used in the U.S. for diagnostic and therapeutic
medical applications and for industrial, environmental and biomedical
research and quality control.
---------------------------------------------------------------------------
CORAR testified before both the Senate and House during the last
Congress in support of the proposed predecessor legislation, H.R. 3276.
Thus, we support S. 99 and the provisions contained in the legislation.
We believe this legislation will provide critical funding, assurance
of, and the regulatory framework necessary to help establish reliable
medical isotope production capabilities in the United States. This
legislation is an important step towards a reliable source of medical
radionuclides for our patients and will contribute to enhancing supply
well into the future. In U.S. hospitals and clinics, Tc-99m (produced
from Mo-99) is administered to more than 40,000 patients each day in
the detection and staging of cancer, detection of heart disease,
detection of thyroid disease, study of brain and kidney function, and
imaging of stress fractures. Thousands of other nuclear medicine
procedures are conducted every day in the U.S. with radionuclides, such
as I-131, I-125, Y-90 and Xe-133, in the diagnoses and treatment of
diseases. These nuclear medicine procedures not only improve the
quality of life, but they save lives. A self-sustaining domestic supply
of radionuclides used in nuclear medicine would ensure our patients
receive the necessary care while reducing our health care costs.
As a supporter of S. 99, CORAR would like to highlight four
specific issues for the Committee's consideration to ensure that the
bill will accomplish its goals and serve the needs of U.S. patients:
1. Section 3c of the legislation contains an important
provision requiring DOE to accept waste created by the
production of medical isotopes from the DOE-leased uranium.
This provision is important because currently there is no
disposal pathway available in the U.S. for the types of
radioactive waste that will be generated in the production of
Mo-99 and other medical isotopes. It is critically important to
the objective of this legislation that DOE accepts such
radioactive waste at reasonable prices. These prices should be
similar to what we would expect to pay for commercial disposal,
if a commercial waste disposal facility were available. This
will help assure new medical isotope production facilities can
be built and operated effectively.
2. The NRC has a comprehensive regulatory framework for
protection of the environment, workers and the public. Any new
reactor or production facility receiving funding under this
legislation will be licensed by the NRC or equivalent Agreement
State agency. Various aspects and operations of these
facilities will also be regulated by the Food & Drug
Administration (FDA), Department of Transportation (DOT) and
the Environmental Protection Agency (EPA), as well as state and
local regulatory agencies. We are concerned that the acceptance
of money from DOE for the development of medical isotope
capability under this legislation may trigger duplicative
National Environmental Policy Act (NEPA) reviews. With these
various levels of regulatory oversight, we do not believe NEPA
will offer any more protection of the environment than that
already provided by NRC, FDA, DOT and others. Triggering of
NEPA by one of these new production facilities could serious
delay the project and significantly increase its cost. We would
like to see a provision in the legislation that any federal
money spent on the development of medical isotopes to be exempt
from the requirements of NEPA.
3. Several groups are working on the development of new types
of isotope production reactors or have plans to utilize
existing reactors for production of medical isotopes. Some of
these reactors may fall into a licensing gap at the NRC. These
new reactors do not meet the definition of a research reactor
under the language in Section 104 of the Atomic Energy Act
(AEA), due to their production focus and lack of research being
conducted. These types of reactors also do not have the
inherent risk or security concerns of large commercial nuclear
power reactors which are licensed under Section 103 of the AEA.
CORAR would like to see S. 99 either revise Section 104 of the
AEA to recognize these types of reactors for the production of
medical isotopes or direct the NRC to permit the licensing of
these reactors under Section 104 of the AEA. If assistance of
this type could be included in the legislation, it would help
expedite the licensing of these new reactors and bring these
new sources of Mo-99 to market more quickly.
4. CORAR is aware of several promising efforts to develop new
medical isotope production technologies. DOE/NNSA has already
awarded cooperative grants to a number of projects based on
different technological approaches. Given the legislation's
intent to broadly serve American patients, future funding
should be directed to the project or projects which stand the
best chance of producing commercially meaningful quantities of
medical isotopes within the time frame envisaged in this
legislation. We also would like to see the process by which DOE
awards development money, fully vetted through a rulemaking or
some other process where our industry and other interested
parties can review and comment on DOE's proposed evaluation
criteria and decision-making process for such projects.
Thank you for the opportunity to testify here today. CORAR is
supportive of this legislation, and hopes to continue to work with the
Committee and staff to ensure both a swift and long term solution to
the medical isotope supply crisis for the benefit of American patients.
I would be happy to answer any questions the Committee may have.
The Chairman. Thank you both very much.
Let me start with a few questions here. Dr. Staples, let me
understand clearly the position that you articulated about this
takeback requirement that is in the legislation. Mr. Brown,
you've indicated, I think, the first of the four items that you
talk about is that it's very important we keep that provision
in there and there be some obligation to take this waste back.
I'm just wondering, Dr. Staples, what is your view on that
again? You stated it in your testimony, but I wanted to be
clear on what it is.
Mr. Staples. Our concern is that we cannot anticipate how
the Uranium Lease Takeback program for the production of Mo-99
actually would be implemented, and the legislation does not
provide funding for that new service. If directed to do so, we
would develop an approach that considers the goal of developing
a sustainable commercial enterprise with thorough diligence for
responsible and safe materials management. We recognize the
importance of meeting those program objectives, but we do
require further guidance and want to be ensured that the sub-
program, the Uranium Lease Takeback program, is not linked to
the production of medical isotopes, just to ensure the timely
development of isotopes for the medical community.
The Chairman. We may need to look at that language and be
sure that it meets the requirement that at the same time there
is an obligation, which Mr. Brown has indicated is very
important.
On the question of how we ensure that the cost of the
Molybdenum-99 that U.S. companies are producing or supplying
will be competitive with that that we obtain overseas, Dr.
Staples, what's your view on that?
Mr. Staples. We are concerned about that. We are concerned,
in fact, of the subsidies provided for the current industry, of
how they produce the medical isotope, and that our U.S.
companies will be undercut in the commercial market by foreign
producers that are heavily subsidized by their governments.
This is a serious challenge facing the fragile Mo-99 market and
in order to ensure reliable supply we want to ask that a level
playing field for all companies be provided, with full cost
recovery across the global market.
This actually is an issue that's been under discussion with
all participants, both the suppliers and the customers, at the
recent Nuclear Energy Agency meeting of the High-Level Group
for Medical Radioisotope production. So it is recognized to be
a concern throughout the industry for the long-term reliability
of isotope supply of Mo-99 for the medical community, while at
the same time we can achieve the nonproliferation objectives by
using non-HEU-based production technologies.
The Chairman. Mr. Brown, do you have a concern about this
problem of the cost that U.S. companies would incur being
undercut essentially by competition from overseas?
Mr. Brown. As I said in my testimony, we're concerned that
the waste takeback provision--that the cost we pay per cubic
yard of waste to dispose of to DOE would be done at reasonable
prices. We wouldn't want to pay exorbitant prices that would
throw the economics of any isotope production off. So what
we're asking for is a reasonable commercial rate for waste
disposal.
The Chairman. But you think with that, with a reasonable
commercial rate for waste disposal, U.S. companies would be
able to compete?
Mr. Brown. We feel we could, yes.
The Chairman. All right. Let me ask one other question, Dr.
Staples, about what actions the Department is working on to
move the Russians to produce Molybdenum-99 with low-enriched
uranium.
Mr. Staples. Yes. Recently, there were several press
releases that came out about a supply being developed in Russia
that was utilizing highly enriched uranium for the production
of Mo-99. We intend to raise this issue at very high levels in
meetings with various Rosatom officials, such as Director
Kiriyenko, to dissuade Russia from the use of HEU, to ensure
that their actions are consistent with their Presidential-level
commitments that they have made at the April 2010 Nuclear
Security Summit to minimize and, where possible, eliminate the
use of HEU in civilian activities.
The Chairman. Let me ask you one other question, Mr. Brown.
Does your council currently see supply meeting U.S. demand for
Molybdenum-99 or do you expect additional shortfalls in the
near future?
Mr. Brown. We are encouraged by some of the new efforts
that are under way. We're very encouraged by some of the
development work, the cooperative grants that DOE has issued
for some new development facilities. We do see some bumps in
the road coming out in the future. We hope to have these new
facilities up and running to minimize any impact of that. But
we're encouraged by the development work that's going on now.
The Chairman. You're not alarmed by the prospect of
shortfalls in the near future?
Mr. Brown. There may be some shortfalls in the future, but
we're encouraged by the development activities that are under
way to make up for those.
The Chairman. All right.
Senator Murkowski. Just to follow onto that, given the
legislation that we have in front of us, do you feel relatively
comfortable that this will help us avoid those bumps in the
road? Is this the level of assurance that you need if we can
resolve the issue, for instance, with the takeback and some of
the other issues you raised?
Mr. Brown. This legislation will be very helpful to
assuring the long-term supply of medical isotopes in the U.S.
It sends us well on our way to developing a domestic supply,
too, with the development money put in there for DOE to issue
additional development grants.
The Chairman. Let me ask, what currently happens to the
waste product from a highly enriched uranium target? Where is
the disposal? Where is it? What does it look like?
Mr. Staples. It's stored, typically onsite at the four
major global producers, in a variety of waste forms, under
physical protection standards that meet IAEA protocol under 255
Rev. 4, which is the guidelines for physical protection for
such nuclear materials.
Senator Murkowski. We had a discussion about the low
enriched uranium. Is there more residual waste product from LEU
as opposed to highly enriched uranium?
Mr. Staples. In a simplistic conversion process from HEU to
LEU where they would simply use a low enriched uranium target
in place of a high enriched uranium target, yes, there would be
additional waste that would be generated.
Senator Murkowski. That becomes a significant factor in
terms of how we deal with the disposal and how we deal with the
waste?
Mr. Staples. Disposition of waste in the nuclear industry
is always expensive and complicated. However, the isotope
production industry actually is not significantly large, that
it would be a reasonable and addressable amount of waste that
would be produced, be it from HEU or LEU. We are developing in
our program, options to minimize the amount of waste produced
and in some cases--and this is what the National Academies
study validated, that we do have some technologies available
that could actually reduce the volumes of waste that are
produced with LEU-based production.
Senator Murkowski. Given the current world production
levels, how long does it take to accumulate enough of the
radioactive waste product that's left over to really pose a
proliferation risk?
Mr. Staples. Currently on a global basis approximately 40
to 50 kilograms of highly enriched uranium is used by the total
global community for isotope production, which according to the
IAEA definition of a ``significant quantity'' is roughly two
significant quantities of nuclear material per year that is
being accumulated by the current global production using highly
enriched uranium.
Senator Murkowski. The question has been raised by some in
industry as to whether or not the legislation is technology-
neutral. Can either one of you speak to that?
Mr. Staples. Yes, I can address that first, and then if Mr.
Brown would like to follow. That is part of the strategy behind
developing multiple technologies to ensure that we do not have
a single point of failure. That is actually a common term of
reference that we use, that we are technology-neutral with the
neutron capture, the accelerator-based, and the solution
reactor technologies not having any linkage to one of the other
technologies, to ensure that we can be successful in
implementation of the program.
Senator Murkowski. Mr. Brown, it's technology-neutral in
your opinion?
Mr. Brown. Yes. So far we've seen DOE give development
grants or cooperative grants to several different types of
technologies. So far their doling out of money has been very
fair across the board. One thing we would like to see, we would
like to avoid giving out, supporting many, many, many different
efforts at one time, some of which may not bear any fruit. We
would rather see a focus on just a few areas that look more
promising. So far, DOE has been doing a good job, we feel,
giving out the development grants.
Senator Murkowski. Here in the United States, where do we
currently export our highly enriched uranium to for medical
isotope production?
Mr. Staples. Currently, we only export our HEU to Canada
for the production of medical isotopes.
Senator Murkowski. Just to Canada then. Where do the other
reactors that provide the U.S. with the Mo-99, where do they
get their HEU?
Mr. Staples. The European reactors use European-obligated
material, which is inside the European Community's control.
Then South Africa utilizes indigenous material for their
production of isotope, although as they transition to low-
enriched uranium production they are receiving some low
enriched uranium from the U.S. for this production process.
Senator Murkowski. Ms. Doane.
STATEMENT OF MARGARET M. DOANE, DIRECTOR, OFFICE OF
INTERNATIONAL PROGRAMS, NUCLEAR REGULATORY COMMISSION
Ms. Doane. We do provide--that's with respect to targets,
but for HEU fuel there are HEU exports to the European
reactors, to The Netherlands, to Belgium. We have a current
application pending for France.
[The prepared statement of Ms. Doane follows:]
Prepared Statement of Margaret M. Doane, Director, Office of
International Programs, Nuclear Regulatory Commission
Mr. Chairman and Members of the Committee on Energy and Natural
Resources, thank you for inviting me to participate in this hearing
today. As Director of the Nuclear Regulatory Commission's (NRC) Office
of International Programs, I am pleased to have this opportunity to
discuss NRC's licensing requirements for the exportation of highly
enriched uranium (HEU) for the production of medical isotopes. My focus
today will be on NRC's regulatory framework for licensing the export of
HEU.
Framework for the Export of HEU
I want to describe the NRC's process in detail so that the
Committee on Energy and Natural Resources has an understanding of the
framework in which the export of HEU from the United States is taking
place. The Atomic Energy Act of 1954, as amended, (AEA) grants the NRC
exclusive jurisdiction to license civilian exports and imports of
source, special nuclear, and byproduct materials to and from the United
States. The NRC's regulations governing such exports and imports are
set forth in Title 10 of the Code of Federal Regulations, Part 110,
``Export and Import of Nuclear Equipment and Material.''
Since 2005, the NRC has licensed seven exports of HEU to Canada and
Belgium for fabrication of fuel or targets for the production of
medical isotopes. The export licenses to Belgium authorized export of
HEU for fabrication of fuel for reactors that produce, among other
things, medical isotopes and the export licenses to Canada authorized
HEU as targets or for the fabrication of targets that are used in the
National Research Universal (NRU) reactor for the production of medical
isotopes. Of the seven licenses issued since 2005, there is only one
active license. Currently, there are two pending applications from
Canada and France for the export of HEU. For additional information on
HEU export licenses issued by the NRC since 1992, please see the
attached table.*
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* Table has been retained in committee files.
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Prior to issuing a license for the export of HEU for the production
of medical isotopes, the NRC works closely with the Executive Branch to
ensure that the export is consistent with applicable U.S. non-
proliferation laws and policies and is not otherwise inimical to the
common defense and security of the United States. HEU may only be
exported to countries that have in place an agreement for cooperation
with the United States in accordance with section 123 of the AEA. These
agreements set out the broad framework under which exports such as this
may be authorized.
Even when the United States has in place an agreement for
cooperation with a country, the Commission must determine, on a case-
by-case basis, whether an individual export to that country meets the
applicable export licensing criteria in Sections 127 and 128 of the
AEA, as codified in the Commission regulations at 10 CFR Sec.
110.42(a). Based on its evaluation, the NRC may impose additional
requirements as conditions to the export license.
Among other criteria, section 110.42(a)(3) requires the NRC to
evaluate the adequacy of the physical protection measures in the
country requesting the HEU. The physical protection guidelines are
established by the International Atomic Energy Agency and are published
in INFCIRC/225/Rev. 4, June 1999, ``The Physical Protection of Nuclear
Material and Nuclear Facilities.'' The NRC participates in U.S.
government physical protection bilateral visits to countries requesting
HEU to confirm that the country's implementation of physical protection
methods and procedures for U.S.-origin HEU is consistent with these
international guidelines. The delegations conducting the physical
protection visits include staff from the NRC; National Nuclear Security
Administration (NNSA); Department of Energy (DOE); Department of State;
and Department of Defense.
Any licensee authorized to export HEU is responsible for compliance
with all applicable requirements of Title 10 of the Code of Federal
Regulations, including NRC's regulations related to transportation and
packaging. Since 2005, all transportation of HEU has been conducted by
DOE's Office of Secure Transportation in accordance with the DOE
requirements and directives. These measures meet and exceed NRC's and
Department of Transportation regulations in this area.
For all HEU export license applications, the NRC would, as it did
for each of the seven prior HEU applications, request the Executive
Branch's judgment on the proposed export, including whether the
proposed export would be inimical to the common defense and security of
the United States or otherwise significant for nuclear explosive
purposes, and whether the export would comply with the terms of the
applicable agreement for cooperation. In the seven prior cases, the
Executive Branch determined that the export would not be inimical to
the common defense and security, would take place pursuant to the
applicable agreement for cooperation, and were consistent with the
provisions of the AEA.
In the Energy Policy Act of 1992, Congress amended the AEA to
require the NRC to adopt additional, more stringent criteria
specifically for licensing exports of HEU. These criteria were designed
to discourage the use of HEU and encourage the development and use of
low-enriched uranium alternatives. Under Section 134 of the AEA, the
NRC may issue a license for the export of HEU to be used as a fuel or
target in a nuclear research or test reactor only if, in addition to
meeting the other AEA requirements for exports of special nuclear
material, the NRC determines that:
(1) There is no alternative nuclear reactor fuel or target
enriched to a lesser percent than the proposed export that can
be used in the foreign reactor;
(2) The proposed recipient of the uranium has provided
assurances that, whenever an alternative nuclear reactor fuel
or target can be used in that reactor, it will use that
alternative in lieu of HEU; and
(3) The U.S. Government is actively developing an alternative
nuclear reactor fuel or target that can be used in that
reactor.
More recently, in the Energy Policy Act of 2005, Congress further
amended the AEA by adding a new section 134b., ``Medical Isotope
Production,'' in which Congress continued to encourage the eventual end
of reliance on HEU targets in the production of medical radioisotopes.
In the new AEA section 134b., Congress lifted certain restrictions on
exports of HEU to Canada, France, Belgium, Germany, and The Netherlands
for the production of medical radioisotopes if the recipient country
supplies an assurance letter to the United States that the HEU will be
used solely for medical isotope production, and if the NRC determines
that the HEU will only be irradiated in a reactor that uses alternative
fuel or is the subject of an agreement with the United States to
convert to alternative fuel when such fuel can be used in the reactor.
The NRC is mindful of the importance of the supply of medical
isotopes for diagnostic and therapeutic medical procedures. Therefore,
the NRC carries out this export licensing regime in an efficient and
effective manner. Our regulations require notice of the application to
the public and the opportunity to request a hearing on whether the
export is consistent with our regulations. We also accept and review
written comments even when a hearing is not requested. Once the various
views are obtained, we then reach a carefully considered decision in
accordance with non-proliferation policies, laws and regulations.
Conclusion
The NRC's exclusive jurisdiction to authorize the export HEU for
production of radio pharmaceuticals for diagnostic and therapeutic
procedures is regulatory in nature and exercised only in accordance
with the statutory framework and Congressional policies established in
the Atomic Energy Act. In carrying out its regulatory responsibilities,
the NRC works effectively with the Executive Branch, the recipient
countries, the public, exporters and importers to assure the exports
will not be inimical to the common defense and security and are
consistent with policies to use alternatives to HEU when appropriate.
Again, I appreciate the opportunity to participate today and look
forward to answering any questions the Committee may have.
Senator Murkowski. Thank you, Mr. Chairman.
The Chairman. Senator Manchin.
Senator Manchin. Thank you, Mr. Chairman.
First of all, let me just say that it's a pleasure and an
honor to be on the committee, and I appreciate it very much.
It's very meaningful for my State of West Virginia to be on the
Energy Committee, and I'm sure we're going to have some
interesting times and I look forward to it. I truly believe
that the security of the Nation depends on the independence
that we have in our production of energy, from every State
doing everything they can.
So I look forward to working with you, Mr. Chairman and
Senator Murkowski and the entire committee, for that.
Sir, if I may, trying to get up to speed and being the new
kid on the block, but learning a little bit about this, I would
just simply ask, what are the implications if we don't pass
this legislation, if something for whatever reason--I know it
got caught up in the 111th Congress. I don't think that's going
to happen, but if it would what would be the scenario for you?
Mr. Staples. There are two implications that are really
driven by this legislation. One is the nuclear security
implications of how we as a government are trying to address
HEU minimization for threat reduction. That's actually--our
commitment is consistent with the pledge that was made by the
leaders at the Nuclear Security Summit in April 2010.
Further implications are for the reliable supply of medical
isotopes to the U.S. community. There are indications that the
Canadian reactor, the NRU, where they currently produce Mol-99,
the bulk of which is used here in the United States, will cease
operations in the 2016 timeframe. At that point, our supply of
medical isotopes is at serious risk for providing the various
procedures that Mr. Brown alluded to recently, which is
primarily the diagnosis of heart disease and then various other
operations or activities that are performed.
Senator Manchin. You had--in 2009 the National Academy of
Science reported it found that the use of highly enriched
uranium in the production of medical isotopes could be phased
out and replaced by low enriched uranium by the 2016 to 2020
timetable. You don't think that can be met?
Mr. Staples. No, we do believe that we can address that
concern. I have a significant amount of confidence in the
activities that we are putting in place to develop these
cooperative agreements with our commercial partners for
reliable isotope supply, and we also have a significant amount
of confidence to be able to transition the international
producers to an LEU-based Mo-99.
Senator Manchin. So the elimination from Canada will not
cause a problem in the United States?
Mr. Staples. If we are successful with developing our
domestic cooperative agreements, that will be the replacement
production capacity that the global medical community would
require to maintain providing their services.
Senator Manchin. What are the potential consequences to any
of you there if it falls into the wrong hands, as far as our
production?
Mr. Staples. I believe that you're referring to the use of
the highly enriched uranium?
Senator Manchin. Yes, correct.
Mr. Staples. Highly enriched uranium can be used by either
terrorists or rogue states to construct an improvised nuclear
device.
Senator Manchin. Has there been any breach of that at all
or any indication that that might be what they're trying to
acquire, or do we have security checks in place to take care of
that?
Mr. Staples. I probably would like to take that question
for the record and get back to you, just to make sure that I am
properly attributing all of the events that might or might not
have taken place.
[The information referred to follows:]
From the NNSA perspective, we are unaware of any indication of
diversions of HEU from the Mo-99 production process.
Senator Manchin. So we don't have any reported incidents
where that's been breached?
Mr. Staples. I am not positive of any definite activity
that has taken place related to Mo-99 isotope production and
highly enriched uranium.
Senator Manchin. Thank you.
The Chairman. Senator Burr.
Senator Burr. Thank you, Mr. Chairman, and I thank you and
Senator Murkowski for calling this hearing and for introducing
the legislation.
I think over the last several years, Mr. Brown, we have had
a supply interruption affecting not just cancer patients, but
all patients. I want to sort of go where Senator Manchin was
and let you sort of take that and run.
Dr. Staples' comment alarmed me greatly. He said: If we are
successful. OK, let's approach it from another angle. If we're
not successful, if the legislation is delayed, if we don't get
the robust participation, if we can't find the private sector
agreements, if the NRC doesn't license, and if production
doesn't run on time, what happens to patients? I don't think
they're sending us signs. Canada's going to shut down in 2016.
Mr. Brown. It's clear, coming from Canada, they do plan on,
from what we understand, re-licensing the NRU in 2011 for
another 5 years, which will terminate in 2016. So that's pretty
clear.
We are very encouraged by the development activities that
are under way now. There are several different private concerns
looking at new technologies and new methodologies, new
production facilities for Mo-99. So we're very encouraged by
that.
This legislation is very important because it helps us
develop a domestic supply of Mo-99.
Senator Burr. But if we don't have Mo-99, if we have an
undersupply or no supply, what does that do to patient care?
Senator Burr. It's used in 18 million procedures a year in
the U.S. Every year, 18 million procedures. We did see
shortages, as you know, in 2010 and it was impacted. Some
hospitals were impacted by the shortage of Mo-99 and
Technetium-99, so it did have an impact. Other technologies
were employed. Other isotopes were used, for example Thalium-
201 for stress tests, for heart imaging. Thalium-201 was used
instead of Technetium-99m. In some cases Fluorine-18 was used
instead of Technetium-99m. In some cases other technologies,
ultrasound, was used. Echo cardiography was used in place of
Technetium. So there are other technologies.
Senator Burr. If all those techniques, if all those tools
were as good as Mo-99, we'd use them today.
Mr. Brown. You're right. It's clear that Technetium-99m is
the preferred method. It collects more diagnostic information.
It's better quality information and it's cheaper.
Senator Burr. Over the long run it costs less in the health
care system. So we're talking about health care cost reduction.
Mr. Brown. You're absolutely right.
Senator Burr. Let me ask you. You talked about the waste
stream. What is a reasonable price?
Mr. Brown. I don't have that number off the top of my head.
We can get back to you on that. What we're looking for is just
we don't want to pay an exorbitant amount that would throw the
economics of any new production facility off. We can get
together with an answer on that.
Senator Burr. Let me suggest to you that that's an
important number to know, and it goes to the heart of what you
said, Dr. Staples, that there has been talk, if I understood
you correctly, that everybody globally would be guaranteed cost
recovery, that all producers would be guaranteed cost recovery.
How do we calculate what that is?
Mr. Staples. In operating in the commercial industry, the
issue now is that governments are providing various subsidies
for their operations. Either the facilities are using
facilities that were initiated through government construction
and then they have transferred over to commercial activity, so
they're fully amortized in terms of government funds rather
than through the commercial activities; or waste disposition is
provided for some of the activities that take place with the
commercial producers.
What we are discussing at the OECD meetings and the Nuclear
Energy Agency is how to implement a full cost recovery for all
of the commercial activities that are undertaken in this
industry to ensure that they can develop and maintain their
production as they would move into the future and that there is
no--that there is no oversupply generated in the market,
either, from any one entity that might be heavily subsidized
and be able to prevent the introduction of another commercial
activity from another country.
Senator Burr. Two things. In the past the Department of
Energy has asked companies to commit to facilities that can
provide approximately 50 percent of the U.S. market demand for
medical isotopes. I would suggest to you this could lead to a
substantial oversupply in the market if all current suppliers
provided 50 percent of the market.
I guess I would ask, if we changed that word to
``significant'' versus ``50 percent'' would that be sufficient
and would it eliminate the risk of oversupply?
Mr. Staples. It could eliminate the risk of oversupply.
That's a very important point that you're making. As I stated
before in the response with the likelihood of the Canadian
reactor ceasing production in 2016, it's the importance that
what we are developing in the United States would be
replacement production capacity to complement the other
production that takes place in the international market.
There are significant dynamic forces at play in the global
isotope production community and this is what we are trying to
coordinate when we work with OECD to ensure that we can have
reliable replacement supply. A significant amount of
overcapacity is also required because of the manner in which
the isotope is produced in reactors which regularly go through
maintenance shutdowns and other periods, to ensure that, while
we can maintain a minimum level, the overcapacity does need to
be maintained within the industry to ensure that we always have
the supply for the medical community.
Senator Burr. Let me just raise for my colleagues this
personal observation. When I see a marketplace that is going to
be coordinated on reimbursement, government influence from the
standpoint of cost calculations, I begin to see a marketplace
that doesn't attract private dollars. I think what we're trying
to set up in the United States is the injection of private
capital to do this, though with the incentive of grants from
the U.S. Government.
So let me just say, we ought to be particularly careful
that the net result of this is that we don't create something
globally that is dominated by government, that takes the health
care cost advantages that we have today and raises the cost
precipitously to where new technologies for the delivery of
care are not developed. I think at the same time you have to
consider that 10 years ago we didn't use as many procedures,
didn't use this. 10 years from now there may be many more
procedures that utilize this. The supply needs may be much
greater.
Mr. Chairman, could I ask one question of Ms. ``DOWN''?
Ms. Doane. Yes, ``DOANE.''
Senator Burr. ``DOANE.''
I guess my question is this. What's a reasonable timeframe
for licensing and production, because the NRC is going to have
to license, right?
Ms. Doane. Yes. I think we've answered--when we answer
these questions, typically we say: Of course, it depends on the
application.
Senator Burr. No, but let me just state this. There is the
health of the American people at play here. So going into this
we've got to have some certainty as to what the time line is
for licensing.
Then I'll turn to Mr. Brown as an industry person later on
and say: Can you make the production capabilities? But if the
NRC delays licensing, it doesn't matter how good we do from the
standpoint of the NNSA or from DOE or from the industry; this
isn't going to happen. We're going to have a gap.
Ms. Doane. No, understandably. I think that we do
understand the importance of licensing these production
facilities and we have started pre-licensing review. I can't
today give you an exact timeframe because the concepts are not
completely developed yet.
Senator Burr. There are no applications yet.
Ms. Doane. There are no applications. But I can tell you
that we are taking it seriously. We're doing a lot of pre-
application work and trying to establish processes that--we
have processes in place, but actually standards and procedures
that will help the proceedings run more smoothly.
Senator Burr. What prescriptive legislation--what
prescriptive language needs to be in this legislation to
encourage the NRC to license new technologies that may be on
the horizon that may not be the standard generation of LEUs
today that NRC might be familiar with?
Ms. Doane. It would be my opinion we don't need new
legislation because our legislation--we have broad discretion
to license new technologies. You can imagine with new reactors,
for example, we're doing all kinds of new types of technology.
I think we do have--I can take this back and ask the lawyers,
but I think for now we have broad discretion and it's just a
matter of setting up the guidelines and the procedures as we
get the applications in.
Senator Burr. The chairman's been awfully lenient with me
and the only thing that I would say in concluding is that on
the electric generation side there has been technology
breakthroughs on smaller, compact nuclear generation units that
have not been received warmly at the NRC because they're new.
Now, I'm not going to tell you that there are applications that
are out there, but there are technologies that are advancing
and certainly things that show promise. Yet from a regulatory
standpoint they don't seem to be moving with the progress that
one would like.
I only hope that that's not the case with new technologies
as it relates to the LEU market and the production that we
need.
Mr. Chairman, I thank you.
The Chairman. I would just make the point, I think I'm
right that there are no applications for these small modular
nuclear reactors, either.
Ms. Doane. No. But we are doing, again, a lot of
prelicensing work to make that run efficiently when we do.
The Chairman. Senator Franken.
Senator Franken. Thank you, Mr. Chairman, and thank you,
Senator Murkowski, the ranking member, for welcoming me
earlier.
I apologize; I'm kind of jumping between this and the
Judiciary Committee hearing. I did read your testimonies last
night, but I did miss your oral testimonies today. So forgive
me if I ask a question that you've already covered.
I just want to say what an honor it is to be on this
committee. It's so clear that energy is central to so many
critical issues, the economy, our national security, the future
of the planet, just those things.
This is a question for pretty much any of you, probably--
for any of you: What is the global buy-in on going to low
enriched uranium to make Mo-99, as opposed to highly enriched
uranium? In other words, are the other nations that produce
this, are they also going to be going to low enriched uranium?
Mr. Staples. I can follow on. That again refers back to the
discussions we just had last week at the OECD conference on
medical isotope production. We also do discuss the issue of
conversion of their facilities to low enriched uranium. As I
mentioned, the South Africans have already begun converting
their process over to LEU and in December provided the first
LEU shipment for commercial distribution here to the United
States.
We are in discussions both with the Dutch and the Belgians
about converting their processes. They have made statements
that they are working in that direction. However, they do want
to be assured that while they work toward conversion toward LEU
that they don't impinge upon their ability to supply isotopes
to the market today, because their production facilities have
limited resources and they need to carefully manage how we work
the conversion program at their facilities while they maintain
the production capacity that's required for the medical
community.
Senator Franken. Mr. Brown, you just nodded.
Mr. Brown. I would have to agree. I think there is general
concurrence of the need to move from HEU to LEU. CORAR is
certainly supportive of that, the philosophy in that bill, in
the bill here.
Senator Franken. Let me ask you then about Iran, because
Iran is our probably biggest proliferation concern. In 2009 we
came close to a confidence-building deal with Iran. Iran would
ship its low enriched uranium out of the country; in return it
would receive the fuel it needed for a research reactor that
produces medical isotopes. But Iran backed out of the deal and
now it's claiming that it needs more highly--to enrich more
uranium to be highly enriched uranium for the purpose of
producing medical isotopes.
So my question is, if we move toward eliminating the use of
highly enriched uranium in the production of medical isotopes,
would that help to undercut the argument that Iran has and
potentially other proliferators might make, that it needs to
enrich its low enriched uranium more highly for medical
purposes?
Mr. Staples. Let me respond to that. I would say yes. Our
efforts, in addition to the 2009 National Academies study, Mo-
99 production efforts by countries such as South Africa,
Australia, and Argentina, and a recent IAEA-coordinated
research project for indigenous production of Mo-99 without the
use of HEU have all demonstrated that highly enriched uranium
is not needed for medical isotope production.
In fact, there's really no economic justification and very
little technical justification for every country to produce its
own enriched uranium for medical isotope production. The
international commercial supply of LEU for medical isotope
production is more than sufficient to meet the needs of the
global medical community.
So the global shortage that we face is primarily due to the
limited large-scale processing facilities to take the
irradiated targets and turn them into the medical commodity
that's used by the community.
Senator Franken. So presumably we could--I mean, our
arguments with Iran don't necessarily prevail, but we can make
the argument to them that they don't need highly enriched
uranium to make these medical isotopes?
Mr. Staples. That is correct.
Senator Franken. OK. Since my time is up, thank you.
The Chairman. If you have any other questions, go right
ahead. Nobody here but us chickens. We're about to finish the
hearing, so go ahead.
Senator Franken. I've got some chickens over at the
Judiciary that I've got to go see.
The Chairman. All right. Thank you very much. Thanks for
your very good questions.
Senator Murkowski, did you have additional questions?
Senator Murkowski. Just a couple quick ones.
Mr. Brown, you mentioned the issue of NEPA review and
further environmental analysis being something that could
potentially delay the process. In addition to Senator Burr's
good questions about the regulatory process, I think we
recognize when we talk about bumps in the road or things that
could be a problem, certainly I think when you interject the
unknown morass of regulation or something like NEPA which is
difficult to project.
Dr. Staples, please provide your comments about the
potential for delay with additional environmental assessment?
Mr. Staples. We have been evaluating that process
significantly to make sure that we can be successful with our
technology-neutral activities. In some cases we do require
significant NRC licensing approval for operation. Some of the
other technologies have different NRC licensing requirements,
such as the accelerator-based technology, which is essentially
non-nuclear and utilizes no uranium for the production of
medical isotopes.
But regarding the NEPA, we have been in close contact with
the Nuclear Regulatory Commission also, to coordinate our NEPA
approaches to ensure that we do not have any duplicate
processes and that we meet our NEPA obligations as a government
and that we do this in the most efficient manner so that we can
ensure the accelerated production of Mo-99 for the United
States.
Senator Murkowski. You don't view a NEPA review as being
duplicative of the other reviews that are currently in place?
Mr. Staples. We need to fulfill that obligation and we are
working closely to coordinate our efforts with the NRC to
accomplish that.
Senator Murkowski. Is there something that we should or
should not include in this legislation that would speak to that
as an issue?
Mr. Staples. I would actually like to take that as a
question for the record, because we have put considerable
thought into that and I don't think I could do full justice to
the response here on the floor.
The information referred to follows:]
To ensure that NNSA's effort is in compliance with the National
Environmental Policy Act (NEPA), GTRI is currently proceeding through
the required NEPA approval process within the U.S. Department of
Energy. The Nuclear Regulatory Commission (NRC) has NEPA requirements
for the licensing process, and GTRI has been coordinating with the NRC
in order to avoid any duplication of nEPA analysis efforts. We have
recognized the potential for this risk to the schedule of the domestic
production projects and are working to implement the required
procedures while maintaining our accelerated schedule to produce Mo-99
for the U.S. medical community.
After a preliminary technical review of the various candidate
technologies to enable the domestic production of Mo-99 within FY10-
FY14, important schedule risks and mitigation strategies have been
identified. Among the most important of the schedule risks is the
obligation to prepare analyses to fulfill the Department's NEPA
obligations. In order to mitigate the schedule risk NEPA requirements
pose to achieving domestic production within the timeframe of this
legislation, high-level political support to expedite all NEPA analyses
is necessary.
Senator Murkowski. I would appreciate that.
Let me ask a question just in terms of deliverability and
how we move things, recognizing that it has a pretty short
lifespan or shelf life, as it relates to the medical isotopes.
What happens when you have an incident like we had in Europe
with the eruption of the volcano that shut down air traffic for
days, a week in certain areas?
We talk about putting a process in place that is going to
make sure that we have a good supply. But if we can't
stockpile, how do we respond to disruptions like we've seen?
Mr. Staples. That speaks perfectly to the point of
developing a diverse, reliable supply with very few single
points of failure and trying to disseminate the production
globally to ensure that any one regional event does not impact
the global medical community.
Senator Murkowski. But right now, because you have so much
production centered in Europe, you have a stumbling block if
something happens.
Mr. Staples. Yes. During the volcanic eruptions I do have
the impression and understanding that we were impacted in terms
of our supply of isotope for some periods of time.
Senator Murkowski. The U.S. was?
Mr. Staples. Yes.
Senator Murkowski. I would assume----
Mr. Staples. Europe.
Senator Murkowski. Europe and beyond; would it not be?
Mr. Staples. Yes.
Senator Murkowski. So at this point in time, we don't have
an answer in place as to how to respond.
Mr. Staples. No. That's actually why your committee's
support for this legislation is very important. We've mentioned
last week at the OECD meeting not to become complacent as a
community as we try to address that. Your continued support
with this legislation will give us the motivation and the
impetus to work with the commercial industry to ensure that we
develop solutions as best as possible for the isotope supply.
Senator Murkowski. Mr. Brown.
Mr. Brown. This legislation also encourages developing of a
domestic supply here in the U.S., where if there is another
volcano we don't have to worry about flying planes from Europe
to the U.S. If we're producing it here locally and have a
domestic supply, obviously volcanoes in Iceland wouldn't be a
problem. So that's why we're encouraged by this legislation. We
think it would help encourage domestic supply.
Senator Murkowski. Thank you, Mr. Chairman.
The Chairman. Thank you very much.
I didn't have any additional questions. Senator Manchin,
did you have additional questions?
Senator Manchin. I just want to thank you all so much, and
the concern that you have and bringing it to our attention. I
want to thank the chairman and Senator Murkowski for being so
diligent on this issue, and I hope to see that we move quickly
on it.
The Chairman. I think that sums up my views as well. I hope
we are able to move quickly on this legislation. Again, I thank
all three of you for being here to give us your views, and we
will conclude the hearing.
[Whereupon, at 10:54 a.m., the hearing was adjourned.]
APPENDIXES
----------
Appendix I
Responses to Additional Questions
----------
Responses of Roy W. Brown to Questions From Senator Bingaman
Question 1. Can you please explain in more detail how CORAR would
determine what it means by a reasonable fee for the fuel take provision
in this legislation?
Answer. A contract with DOE to accept the High Level Waste produced
as a result of Mo-99 and other medical isotope production is critical.
Under S. 99 the uranium would be leased from DOE and taken back. The
legislation doesn't appear to determine whether the waste taken back is
a commodity or a waste when received by DOE. How DOE categorizes the
``waste'' is not that important, unless it makes a difference in the
``reasonable fee''. While industry expects to pay for the waste
disposal, we also cannot afford a heavy burden in the form of fees to
take back the waste. A DOE program similar to what they do for research
reactors might be a model--assuming the cost of providing and taking
back uranium is reasonable. A High Level Waste fund, similar to what
commercial power reactors have with their standard contracts, would be
unworkable. CORAR recommends DOE charges a fee for this waste disposal
that would be comparable to what commercial fees would be, if
commercial waste disposal for this type of waste were available.
Question 2. Do you see Positron Emission Tomography as a cost
effective replacement to Molybdenum-99?
Answer. Positron Emission Tomography (PET) is an emerging
technology that provides a complementary option for imaging certain
types of tumors and staging cancer. It currently provide approximately
2 million imaging procedures each year in the U.S. compared to
approximately 17 million using Tc-99m from Mo-99. It is more expensive
than comparable Tc-99m studies, even though the cost for PET scans has
steadily decreased over the last ten years. PET currently accounts for
a small amount of myocardial perfusion imaging studies (including
through use of rubidium-82 generators). F-18 based PET (half life of
110 minutes, as opposed to 70 seconds for rubidium-82) for myocardial
perfusion imaging will not become commercially available for at least a
few more years. PET is currently more expensive than SPECT, but given
the higher quality images, increased diagnostic certainty and potential
for blood flow quantification with PET, even at a higher per procedure
price, F-18 based PET could rapidly become a cost effective alternative
to SPECT in a number of different contexts. Currently, PET is viewed to
be complementary rather than a replacement for Tc-99m.
Question 3. In CORAR's opinion what technology do you see as the
quickest to market for domestically producing Molybdenum-99?
Answer. There are several new technologies being examined for the
production of Mo-99. The traditional methodology entails fissioning U-
235 with neutrons for the production of Mo-99 and other medical
isotopes. Other technologies being examined include neutron capture
using Mo-98, accelerator production of Mo-99 using Mo-100 targets, and
production of Tc-99m using a proton beam from an accelerator onto a Mo-
100 target. The use of aqueous homogenous reactors, which have cost and
waste reduction attributes, is also being developed. Many of these new
technologies are being developed simultaneously. It is not clear yet
which of these new technologies will lead to the most efficient
production of Mo-99 with the shortest development time. For that reason
CORAR feels it is important to promote all credible technologies on
parallel paths and allow the most efficient method to emerge.
Question 4. How large a market do you see Russia providing for
Molybdenum--99 from Highly Enriched Uranium?
Answer. The current supply chain of Mo-99 coming from Russia is the
production at the Research Institute of Atomic Reactors in
Dimitrovgrad. Initial quantities through the Nordion supply chain are
expected to be incremental. Over several years, the expectation is to
have supply available from the Russian Federation of up to 20% of
global Mo-99 demand to back up Nordion's long-term requirements. The
evaluation process, for samples of Mo-99 from the Russian Federation,
has been initiated through the Nordion Canada facility. Nordion
continues to work with the Russian Federation to bring this commercial
back-up supply of Mo-99 on-line. Specific details of the supply
agreement are confidential.
The Russian supply agreement provides for the parties to address
LEU conversion of the Isotope Mo-99 productions facilities. The timing
and approach of conversion are currently under discussion for
finalization.
Following a meeting of the Nuclear Energy and Nuclear Security
Working Group of the bilateral Russian-US Presidential Commission in
Moscow on December 7th, 2010, an agreement was signed between Russian
state nuclear energy company Rosatom and the DOE. The two organizations
will initially consider the possibility of converting six Russian
research reactors from HEU to LEU fuel.
Nordion has also recently entered into a Framework Agreement with
the Kurchatov Institute in the Russian Federation to collaborate in the
development of medical isotope production capabilities using Liquid
Homogenous Reactor technology, utilizing LEU-based production. This
initiative is aimed at providing additional LEUbased Mo-99 production
capacity from the Russian Federation.
At the Kurchatov Institute in Moscow, the Argus reactor was
originally commissioned in 1981 and is currently the only stationary
LHR (Liquid Homogeneous Reactor) left in operation in the world.
Conversion of the Argus reactor to LEU has been recently approved by
Russian Government as a result of the recent agreement signed by Russia
with US DOE.
At present a conceptual modular production system with a capacity
of 5-10% of the global Mo-99 demand is being considered. Multiple units
could ultimately deployed using this technology depending on Markey
dynamics. The timeframe to achieve commercial production of Mo-99 using
this technology is currently being assessed and is expected to be 3-5
years.
______
Responses of Parrish Staples to Questions From Senator Bingaman
Question 1. Can you please explain the contract you have undertaken
with South Africa to produce Molybdenum-99 (Mo-99) from LEU,
specifically technology used, the amount and duration?
Answer. The National Nuclear Security Administration's Global
Threat Reduction Initiative's (NNSA-GTRI) Mo-99 program has two
separate missions: (1) highly enriched uranium (HEU) minimization
through conversion of existing facilities and (2) support for
accelerating existing commercial projects in the United States in the
production of a domestic, non-HEU-based supply of Mo-99. GTRI entered
into a contract with the South African Nuclear Energy Corporation
(Necsa), and its subsidiary NTP Radioisotopes, in order to accelerate
the conversion of their existing production capability from the use of
HEU targets to low enriched uranium (LEU) targets. The technology
utilized in the conversion process was developed and implemented by
Necsa/NTP and is proprietary. The contract with Necsa is worth up to
US$25M and is designed to accelerate the implementation of their
technology and to complete the conversion of the facility by the end of
2013. As this contract falls under GTRI's HEU minimization mission, it
is intended to support Necsa in maintaining its current production
capability as it transitions to LEU-based production. GTRI's support to
South Africa is not intended to augment South Africa's ability to
produce additional amounts of Mo-99 for the global market.
Question 2. Were you able to convince any U.S. reactor operators to
use the LEU technology developed by the NNSA before contracting with
South Africa?
Answer. Removing the HEU from South Africa is a high non-
proliferation priority, as HEU could be used to make a nuclear weapon
if it fell into the wrong hands. NNSA is cooperating with the South
Africans to remove the HEU while demonstrating that the reactor can
still be used for isotope production. NNSA's efforts in the United
States are quite different, as we are working to establish, rather than
convert, Mo-99 production facilities. There has been no domestic
production of Mo-99 since Cintichem's 1990 decision to decommission the
Tuxedo reactor located in Tuxedo, New York.
The decision for the specific technologies being developed for the
conversion of existing international Mo-99 producers to LEU, or for
development in the United States, is driven by the producers
themselves. NNSA's LEU target technology is one of many possible
technologies these producers may have used. The technology utilized in
the conversion process in South Africa was developed by and is unique
to Necsa/NTP and is proprietary. The contract between NNSA-GTRI and
Necsa is designed to accelerate the implementation of Necsa's
technology and to complete the conversion of the Necsa facility by the
end of 2013.
Each of the U.S. domestic projects uses a technology selected and
implemented by the potential producer. As these are independent,
commercial projects, GTRI is only providing support to accelerate their
timeline to help ensure that the United States and its medical
community have access to a reliable domestic supply of Mo-99 as soon as
possible. The technology developed by NNSA and Argonne National
Laboratory is publicly available and was an option under the recently
issued Funding Opportunity Announcement. However, none of the proposals
submitted from the domestic commercial entities utilized this specific
technology.
Responses of Parrish Staples to Questions From Senator Cantwell
Question 3. Washington State University (WSU) in my state has a
research reactor that has been fully converted to low enriched uranium
(LEU) fuel, and is capable of supplying a significant portion of U.S.
demand for molybdenum-99 and other medical isotopes. I commend the
Department of Energy and the National Nuclear Security Administration
for their efforts to establish grant programs to accelerate the
development of a medical isotope industry that does not use highly
enriched uranium (HEU). What is the current status of awarding grants
for such projects?
Answer. NNSA issued a Funding Opportunity Announcement (FOA) for
LEU target technology and accelerator technology on March 26, 2010,
which resulted in the selection of two cooperative agreement partners
to demonstrate the accelerator technology.
In general, large-scale quantities of LEU-target-based Mo-99
production require a research reactor that operates steady-state, has a
short operating cycle, can dedicate operating time to Mo-99 production,
and runs with sufficient power and neutron flux to produce Mo-99. There
are few facilities in the United States that meet these requirements.
While there are some research reactors in the United States that could
irradiate LEU targets, a processing facility with dedicated hot-cells,
optimally co-located with the reactor, and with a staff experienced in
isotope production using FDA good manufacturing practice are also
necessary for producing Mo-99. The United States does not currently
have hot-cells that are dedicated to this purpose, and the LEU-target
technology project will likely require the construction of a new, co-
located processing facility.
Question 4. What is involved in converting a reactor from HEU to
LEU fuel? What is the typical timeline for such a conversion? What
kinds of technological risks affect this timeline? How much reactor
and/or Mo-99 production downtime would be required to make this
conversion?
Answer. The process to convert a reactor from HEU to LEU fuel
follows a few generalized steps. First, feasibility models are
calculated to demonstrate the viability of conversion, and to verify
that commercially available fuel can be used safely in the reactor
without disruption to the basic parameters required to achieve the
facility's mission. Next, a detailed analysis and safety report is
prepared in order to obtain regulatory approval. Finally, new LEU fuel
is manufactured for the reactor for LEU-based operation upon its
licensing conditions. The typical timeline for this process varies
widely, but is generally not less than two years and in some cases can
take as long as five years depending on resource availability.
Additionally, some high performance reactors cannot be converted
with existing qualified LEU fuels and require a new high-density LEU
fuel, which NNSA is in the process of developing.
Typically, the actual conversion process involving the insertion of
LEU fuel is accomplished during a normal shutdown period for
maintenance or during refueling operations. In either case, the
physical process rarely takes longer than one month.
The conversion process above describes the conversion of the
reactor fuel from HEU to LEU. In addition to converting the reactor
fuel, the targets used to produce Mo-99 also require conversion to LEU.
By converting both the reactor fuel and Mo-99 targets, the use of HEU
in civilian applications is significantly minimized worldwide.
Question 5. In your opinion, would it be preferable to produce
medical isotopes from an existing LEU-fueled source rather than an HEU-
fueled source that would need to be converted at a later date?
Answer. Although LEU-fueled reactors are preferable from the
perspective of nonproliferation, the decision of whether an HEU or LEU
fueled facility would be considered preferable for isotope production
is not determined by the level of enrichment of the fuel. For example,
the specific design and size of the facility for isotope production, as
well as other R&D projects, are more important for medical isotope
production than the fuel enrichment. Isotope production is better
suited to a facility specifically designed for large scale production,
not necessarily whether the facility operates on an HEU or LEU-based
fuel.
That said, all of NNSA's Cooperative Agreement partners use
technologies consistent with U.S. nonproliferation objectives, in that
they do not utilize HEU in the production process.
Question 6. Please give a brief overview of the technology options
available for producing medical isotopes without HEU, and the current
status of each from a technical and commercial feasibility standpoint.
Answer. The basic strategy of NNSA's Mo-99 program is to accelerate
the commercial establishment of a diverse and reliable domestic supply
to avoid any single point of failure. NNSA is supporting three separate
non-HEU-based technology pathways: solution reactor, neutron capture,
and accelerator. The fourth technology described in this section, LEU
target, is an available technology option, but one that ultimately was
not pursued under the FOA. The goal of the program is to support the
establishment of domestic commercial production as rapidly as possible
where economic forces will dictate the future market for medical
isotopes.
The following technology options are alternatives to produce
medical isotopes without the use of HEU.
1. Solution Reactor Technology--Solution reactor technology
has been demonstrated and there is experience in operating
homogeneous solution reactors. Production rates for this
technology are expected to be among the highest of the
different technologies being considered, although additional
R&D on fuel solution chemistry during operation and the
recovery of Mo-99 from the irradiated fuel solution is
required. This production process generates radioactive waste,
although total amounts are less than those generated by the
standard fission-target technology.
2. Neutron Capture Technology--This process is based on
neutron capture in targets of Mo-98. This is a well known
technology and is historically how Mo-99 was supplied to the
medical community when the industry was first being developed.
It is based on utilizing Mo-98 targets and a source of
neutrons, which are captured in the target resulting in the
production of Mo-99. As with the accelerator-based
technologies, this technology has the benefit of resulting in a
minimal amount of radioactive waste, compared to the standard
fission-target technology, although it has a lower specific
activity than fission-based Mo-99 processes. Since current
generators in the nuclear pharmacies cannot use the Mo-99
generated from this process, another design would need to be
developed.
3. Accelerator Technologies--The first proposed accelerator
technology is based on exposing Mo-100 targets to high energy
gamma rays to induce a reaction that produces Mo-99. The major
components of this option are based on proven technologies.
Once the technology is demonstrated in a complete process, it
offers the possibility of relatively simple operation from the
standpoints both of the accelerator and the target processing
facility, because of the reduced radioactive environment in the
absence of fission products. This non-fission based technology
has the benefits of resulting in minimal radioactive waste
compared to the standard fission-target technology. R&D is
needed for the Mo-100 target designs and for the overall proof
of concept. The lower specific activity of the Mo-99 (compared
to fission-based processes) resulting from this process
prevents current generators from being suitable for use,
requiring the development of another generator design.
The second proposed accelerator technology is based on
fissioning an LEU aqueous target through the introduction of
accelerator-produced neutrons. Since the technology fits into
the existing supply chain, where Mo-99 is extracted from
uranium fission products before it is purified, there may be a
lowered cost of production. R&D is currently underway to prove
the concept and scale up the concept for major production.
4. LEU Target Technology--The irradiation of solid uranium
targets with a neutron source to produce Mo-99 is a
demonstrated technology currently used by the industry (most
current production is done with HEU targets). The overall
process (target preparation, irradiation, and dissolution)
using LEU targets is nearly identical to that of using HEU
targets and may therefore offer an easier transition for HEU-
based producers. Production rates for a LEU target facility are
expected to be among the highest of the different non-HEU
technologies being considered. Development of the processing
facilities to dissolve the targets and extract Mo-99 needs to
take place to support eventual production; however, some LEU
production facilities are already in existence, such as in
Australia, Argentina and others, as listed in the 2009 National
Academies report ``Medical Isotope Production without Highly
Enriched Uranium.'' In addition, fission-based technology can
use existing Tc-99m generators, which will expedite the
delivery of Mo-99 to the market. However, among the
technologies considered, fission-based production generates the
most radioactive waste.
NNSA is not providing support for this technology as the
company selected for demonstration of the LEU target technology
ultimately declined the FOA award.
The Organization for Economic Cooperation and Development's
Nuclear Energy Agency (OECD-NEA) published a report, ``The
Supply of Medical Radioisotopes: Review of Potential
Molybdenum-99/Technetium-99m Production Technologies,'' that
describes both these and additional technical pathways to
producing Mo-99. It can be found on the OECD's website at:
http://www.oecd-nea.org/med-radio/reports/Med-Radio-99Mo-Prod-
Tech.pdf. This report is currently the most conclusive study on
the potential technologies for producing Mo-99, and was
produced in response to a request by the OECD-NEA's High-Level
Group on the Security of Supply of Medical Radioisotopes (HLG-
MR), of which Dr. Parrish Staples is one of two U.S. government
representatives.