[Senate Hearing 111-314]
[From the U.S. Government Publishing Office]
S. Hrg. 111-314
MEDICAL ISOTOPES
=======================================================================
HEARING
before the
COMMITTEE ON
ENERGY AND NATURAL RESOURCES
UNITED STATES SENATE
ONE HUNDRED ELEVENTH CONGRESS
FIRST SESSION
TO
RECEIVE TESTIMONY ON H.R. 3276, THE AMERICAN MEDICAL ISOTOPES
PRODUCTION ACT OF 2009
__________
DECEMBER 3, 2009
Printed for the use of the
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COMMITTEE ON ENERGY AND NATURAL RESOURCES
JEFF BINGAMAN, New Mexico, Chairman
BYRON L. DORGAN, North Dakota LISA MURKOWSKI, Alaska
RON WYDEN, Oregon RICHARD BURR, North Carolina
TIM JOHNSON, South Dakota JOHN BARRASSO, Wyoming
MARY L. LANDRIEU, Louisiana SAM BROWNBACK, Kansas
MARIA CANTWELL, Washington JAMES E. RISCH, Idaho
ROBERT MENENDEZ, New Jersey JOHN McCAIN, Arizona
BLANCHE L. LINCOLN, Arkansas ROBERT F. BENNETT, Utah
BERNARD SANDERS, Vermont JIM BUNNING, Kentucky
EVAN BAYH, Indiana JEFF SESSIONS, Alabama
DEBBIE STABENOW, Michigan BOB CORKER, Tennessee
MARK UDALL, Colorado
JEANNE SHAHEEN, New Hampshire
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 New Mexico................ 1
Brown, Roy, Federal Affairs Senior Director, Council on
Radionuclides and Radiopharmaceuticals (CORAR), St. Louis, MO.. 11
Crowley, Kevin D., Ph.D., Senior Board Director, Nuclear and
Radiation Studies Board, National Research Council, The
National Academies............................................. 7
Murkowski, Hon. Lisa, U.S. Senator From Alaska................... 2
Staples, Parrish, Director, Office of European and African Threat
Reduction, Global Threat Reduction Initiative, National Nuclear
Security Administration, Department of Energy.................. 4
APPENDIXES
Appendix I
Responses to additional questions................................ 27
Appendix II
Additional material submitted for the record..................... 39
MEDICAL ISOTOPES
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THURSDAY, DECEMBER 3, 2009
U.S. Senate,
Committee on Energy and Natural Resources,
Washington, DC.
The committee met, pursuant to notice, at 10:02 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 NEW
MEXICO
The Chairman. OK. Why don't we get started? Let me thank
the witnesses for coming to talk with us today.
Dr. Staples, I understand you used to be at Los Alamos, and
we wanted to recognize that, as a former New Mexican.
Today's hearing is to receive testimony on H.R. 3276, the
American Medical Isotopes Production Act of 2009, which was
voted out of the House on a bipartisan basis. It addresses the
recommendations of the report prepared by the National
Academies of Science on the feasibility of producing medical
isotopes, principally molybdenum-99 without highly enriched
uranium, the principal material used in a fission-based nuclear
weapon over 60 years ago and which we are urgently trying to
collect around the world today.
As an incentive to limit the export of HEU, the bill
authorizes a $163 million program to work with industry to
convert existing HEU-fueled reactors capable of producing
isotopes, as well as other alternate methods such as
accelerators.
If this bill becomes law, I hope that the department places
an emphasis to work on the needs of industry to make this
transition because, ultimately, it is the industry that will
produce the isotopes that we need.
Let me call on Senator Murkowski for any statement she
would like to make, and then we will hear from the witnesses.
[The joint prepared statement of Mr. Markey and Mr. Upton
follows:]
Joint Prepared Statement of Hon. Edward J. Markey, U.S. Representative
From Massachusetts, and Hon. Fred Upton, U.S. Representative From
Michigan
Chairman Bingaman, Ranking Member Murkowski, and Members of the
Committee, thank you very much for holding this important hearing on
H.R. 3276, the American Medical Isotopes Production Act of 2009. We
deeply appreciate that the Senate Energy and Natural Resources
Committee has taken up this bill, which we wrote and passed through the
House of Representatives to solve the crisis in nuclear medicine.
The American Medical Isotopes Production Act will safeguard
Americans' healthcare and our national security. By helping to
establish production of critical medical isotopes here at home, the
American Medical Isotopes Production Act will end our dependence on
aging nuclear reactors outside of our borders. And by responsibly
ending the export of weapons-usable highly enriched uranium for medical
isotope production, this bill will give a much-needed boost to U.S.
efforts to permanently convert all reactors away from the unnecessary
and dangerous use of bomb-quality material.
The United States is facing a crisis in nuclear medicine. We face a
severe shortage of a crucial radioactive isotope, molybdenum-99, which
is required for nearly 50,000 medical procedures each day, usually to
produce a detailed image, such as a cancer or bone scan. The shortage
of this isotope, which usually costs only $10 of a multi-thousand
dollar procedure, is threatening the healthcare of millions of
Americans.
Worst of all, the United States does not currently produce any of
the isotope in question domestically. Instead, we are entirely
dependent on a handful of foreign nuclear reactors, most of which are
several decades old, some of which are literally falling apart, and
which rely upon weapons-usable highly enriched uranium for their
operation.
In May, the 51-year old Canadian NRU reactor broke down. It is not
yet clear whether the reactor will ever operate again. And in mid-July,
the 47-year old HFR reactor in The Netherlands was taken off-line for
maintenance for one month.
Together, these two reactors usually produce the entire isotope
supply for the United States. While the nation was able to secure a
small supply during this time from other reactors, Americans' health
care suffered as a result.
This bipartisan bill will solve the medical isotope crisis by
authorizing $163 million for the Department of Energy to evaluate and
support projects in the private sector or at universities to develop
domestic sources of the most critical medical isotopes. This is
necessary because we currently face a daunting supply shortage, caused
by technical problems at the aging foreign reactors upon which we are
reliant. With a robust and reliable domestic production capacity the
50,000 daily procedures which normally occur in this country, including
for cancer scans and bone and brain imaging, will be secure.
In addition, the nuclear nonproliferation benefits of this bill are
significant and timely.
Shockingly, United States still allows for nuclear weapons-grade
highly enriched uranium to be exported to other countries for medical
isotope production. This 1950s-era policy simply does not work in a
post-9/11 world; it is dangerous and unnecessary and must come to an
end. We simply cannot afford to have additional nuclear weapons
materials in circulation--when we know that terrorists would like
nothing more than to steal or buy such dangerous materials.
Fortunately, according to the National Academy of Sciences, there
are no technical or economic reasons why medical isotopes cannot be
produced with low enriched uranium.
Currently, nuclear medicine is practiced mostly in the most
developed countries, like the United States. But that is changing. And
as more countries practice more nuclear medicine, more medical isotopes
will need to be produced. For many years, there has been strong
bipartisan agreement that weapons-usable nuclear material must be
secured throughout the world. It is very much in the national security
interests of the United States that the future growth of nuclear
medicine internationally does not increase the use of highly enriched
uranium. By sending the strongest possible signal that the United
States will not use highly enriched uranium itself, and by setting a
deadline for the end of U.S. exports of this dangerous material, H.R.
3276 will help ensure that the new medical isotope production around
the world will be consistent with international security.
By sending a clear signal that the United States will no longer
export this dangerous material, H.R. 3276 will accelerate U.S. efforts
to convert reactors around the world from highly-enriched to low-
enriched uranium. In fact, this has already begun, as the Department of
Energy testified before our Subcommittee in September that all the
medical isotope production reactors around the world which still use
highly enriched uranium have approached DOE to ask for assistance in
converting to low-enriched uranium in the past few months.
We are proud that this bill has the support of a wide variety of
stakeholders, including the unanimous support of industry and the
nuclear medical community, and nuclear nonproliferation advocates. It
has been endorsed by the Society for Nuclear Medicine, the American
College of Radiology, the American Society for Radiation Oncology, the
American College of Cardiology, the American Society of Nuclear
Cardiology, the American Association of Physicists in Medicine, the
Health Physics Society, the Council on Radionuclides and
Radiopharmaceuticals, Lantheus Medical Imaging, Covidien, Astellas
Pharma US, Babcock and Wilcox, GE Hitachi, the University of Missouri,
the Nuclear Threat Initiative, the Union of Concerned Scientists,
Physicians for Social Responsibility, and the Nonproliferation Policy
Education Center.
The professional medical societies which have endorsed H.R. 3276
represent more than 100,000 physicians, nurses, scientists,
pharmacists, and technicians who provide nuclear medicine every day in
the United States. Their important assistance in the development of
this bill, and their strong support for the legislation, give us
extraordinary confidence that H.R. 3276 represents the best possible
path forward to establish a robust domestic supply of medical isotopes
while reducing the quantity of dangerous weapons-usable uranium in use.
We are also very proud that this bill is a strongly bipartisan one.
We have worked together, across the aisle, for months to craft a robust
solution to the medical isotopes crisis. H.R. 3276 followed regular
order in the House, with a legislative hearing in our Subcommittee,
votes in both the Subcommittee and the full Energy and Commerce
Committee, and finally passed the House in a bipartisan. We worked with
our colleagues on a bipartisan basis to address all concerns which were
raised, and we are very pleased that the bill which passed the House
won overwhelming support.
Finally, we are pleased that we were able to craft this bill to not
only solve the medical isotope crisis and strengthen national security,
but also to do so with full budget neutrality, according to the
Congressional Budget Office.
This bill will help assure that America has a reliable domestic
source of the radioisotopes needed for life-saving medical procedures
and will close a dangerous loophole in our nation's nonproliferation
policy by phasing out exports of highly enriched uranium. We thank you
again for your attention to this crucial issue, and stand ready to
assist in any way as you proceed.
STATEMENT OF HON. LISA MURKOWSKI, U.S. SENATOR
FROM ALASKA
Senator Murkowski. Thank you, Mr. Chairman.
I appreciate you holding the hearing. We are engaged in
great detail on the floor right now with healthcare reform.
This particular issue certainly is not generating as much of
the headlines when we think about health issues. But I have
learned a great deal just in preparing for this hearing, and we
recognize the direct impact that this issue has on thousands of
Americans every day.
We recognize that our hospitals and pharmacies are facing a
shortage of molybdenum-99, the parent product of a number of
medical isotopes and perhaps most importantly, the technetium-
99m, which is used in more than 16 million medical procedures
each year, over 40,000 each day.
I think we recognize that here in Congress there is not
much that we can do in the immediate term to address the
shortage because we rely entirely upon foreign sources for
these isotopes. The foreign reactors we have been reliant upon
to produce the Mo-99 are aging and are either shut down for
repairs or scheduled to shut down next year.
I think we recognize that this committee has held many,
many hearings about our dependence on foreign sources of oil.
At least we have some level of domestic production for now. But
when it comes to the medical isotopes, the U.S. uses half of
the world's supply of the technetium-99m while producing none
here at home. When we talk about energy independence and energy
self-sufficiency, I think we also need to push that further
into the discussion in terms of our reliance on the medical
isotopes that so many Americans depend upon.
The bill before the committee certainly seeks to help
promote domestic production of the Mo-99. This is a worthy
goal. It is also targeted at the potential proliferation of
highly enriched uranium. While I am not as convinced that the
exportation of a few grams of HEU for medical isotope
production is a tremendous proliferation concern, I am
supportive of the bill's intent to utilize the low-enriched
uranium for targets and for fuel.
What the bill does not do, however, is provide a near-term
solution to the shortage that we are experiencing today or the
even greater shortage that we could experience next year. So I
look at this and think it is more important that we get the
policy right rather than try to rush something into law.
How long it will take to get domestic production facilities
up and operating given the environmental, the siting issues,
the NRC licensing hurdles, these are significant questions.
Does the hard cutoff date on HEU exports realistically match up
with the timeline for domestic production? Will Congress and
the administration support long-term funding for this program
to keep it on track during that timeline?
These are some of the questions that I hope we will be able
to have some discussion on this morning. I appreciate your
being here, and you, Mr. Chairman, for calling the hearing.
The Chairman. Thank you.
Why don't I introduce the three witnesses, and then we will
hear from each of them.
Mr. Parrish Staples is the Director of European and African
Threat Reduction at the Department of Energy in the NNSA. We
appreciate you being here.
Mr. Kevin Crowley is the Director of Nuclear and Radiation
Studies Board with the National Research Council of the
National Academies here in Washington.
Mr. Roy Brown is the Federal Affairs Senior Director with
the Council on Radionuclides and Radiopharmaceuticals in St.
Louis.
Thank you all for being here.
Dr. Staples, why don't you go ahead? If each of you could
take 5 or 6 minutes and tell us the main things we need to know
on this subject, and then we will have some questions.
STATEMENT OF PARRISH STAPLES, DIRECTOR, OFFICE OF EUROPEAN AND
AFRICAN THREAT REDUCTION, GLOBAL THREAT REDUCTION INITIATIVE,
NATIONAL NUCLEAR SECURITY ADMINISTRATION, DEPARTMENT OF ENERGY
Mr. Staples. Thank you.
Chairman Bingaman, Ranking Member Murkowski, and other
members, thank you for the opportunity to testify about the
National Nuclear Security Administration's, NNSA's, efforts to
minimize and, where possible, eliminate the use of highly
enriched uranium, HEU, in the production of molybdenum-99,
which is known as Mo-99.
My testimony will describe the benefits of the proposed
American Medical Isotopes Production Act of 2009 and our
efforts to accelerate the establishment of a domestic
commercial supply of Mo-99 without using HEU.
Now, as you just mentioned, Mo-99 is the parent isotope of
technetium-99m, which is the actual radioisotope that is used
in over 40,000 diagnostic medical procedures every day in the
United States. Interruptions in production, expected to
continue through 2010, place patient lives at risk if the
diagnostic tests cannot be performed. Currently, the United
States depends on foreign producers that use HEU targets in
their production process.
The American Medical Isotopes Production Act of 2009 will
provide the long-term authorization to enable the development
of a reliable domestic supply of Mo-99 and further global HEU
minimization efforts by ensuring that new domestic sources of
Mo-99 are non HEU-based. We have been significantly aided by
the National Academies report confirming that the production of
Mo-99 without the use of HEU is both technically and
economically feasible and that there are ``no technical reasons
that adequate quantities of medical isotopes cannot be
produced'' without the use of HEU.
Now, to address the longer-term production of Mo-99, NNSA
is implementing projects to accelerate the establishment of a
domestic commercial supply of Mo-99 without HEU. To prevent a
single point of failure, NNSA is intending to demonstrate the
feasibility of production with commercial entities on four
independent technical pathways. These include LEU fission
target technology, LEU solution reactor technology, neutron
capture technology, and accelerator-based technology.
The goal is for each technology pathway to be independently
and commercially successful, and therefore, our approach is
technology neutral. NNSA intends to follow through on this
program by requesting the necessary funds to implement these
projects with the potential commercial Mo-99 producers whose
projects are in the most advanced stages of development.
The goal is to accelerate the efforts to produce in
adequate quantities for the needs of the U.S. medical community
by the end of 2013. This strategy will help to diversify and
stabilize the Mo-99 supply.
Now to accomplish this, we must overcome the technical
complexity that is involved in extracting and processing the
final medical product at a steady state and on a commercial
scale to meet FDA standards for human consumption. This is a
complex endeavor and experienced commercial-scale producers
with new projects have experienced delays or, in fact, have
failed as they have grappled with the problems of bringing new
facilities into operation.
We must learn from their difficulties and maintain our
focus on the demonstration of commercial-scale Mo-999
production by those few entities that are the most advanced
under our technology-neutral process in order to succeed.
Now I thank Senator Bingaman and the committee for your
continued leadership in supporting this legislation that will
provide national visibility to address this critical medical
need and important nonproliferation goal.
I would be pleased to answer any questions you have at the
appropriate time.
Thank you.
[The prepared statement of Mr. Staples follows:]
Prepared Statement of Parrish Staples, Director, Office of European and
African Threat Reduction, Global Threat Reduction Initiative, 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) efforts to minimize and, where
possible, eliminate the use of highly enriched uranium (HEU) in
civilian nuclear applications, including in the production of medical
radioisotopes. My testimony will include a description of the benefits
of the proposed American Medical Isotopes Production Act of 2009, the
NNSA's effort to mitigate the impact of the current and anticipated
shortages of the medical isotope Molybdenum-99 (Mo-99), and the efforts
to accelerate the establishment of a domestic commercial supply of Mo-
99 without using HEU.
As described in Section 2 of the American Medical Isotopes
Production Act of 2009, Mo-99 is the parent isotope of Technetium-99m,
which is used in approximately 50,000 diagnostic medical isotope
procedures every day in the United States. It has a very short half
life and therefore cannot be stockpiled. It must be produced on a
continuous basis to meet the needs of the medical community, and any
interruptions in production can place patients' health at risk if
diagnostic tests cannot be performed. Currently, the United States
depends entirely on foreign producers for all of its Mo-99, and these
producers use highly enriched uranium (HEU) targets to produce this
vital medical isotope.
Historically, Mo-99 production processes have utilized the same
form of HEU that can be used to produce nuclear weapons and nuclear
explosive devices. Underscoring the global recognition of the grave
threat posed by HEU falling into the wrong hands, including the risk of
terrorists or rogue states acquiring such material, new technical
advances in Mo-99 production processes--just as in other civilian
applications--are demonstrating that HEU is no longer required.
Provisions of this legislation, in particular Section 2, paragraph (11)
are aligned with the NNSA's mission to convert or assist in the
conversion of research reactors worldwide from the use of HEU-based to
LEU fuels and to convert medical isotope production from HEU to non-HEU
based production.
The American Medical Isotopes Production Act of 2009 under review
by this committee would provide a long-term authorization to address
this critical medical need by developing a domestic source of Mo-99 as
well as furthering global HEU minimization efforts by ensuring that new
domestic supplies of Mo-99 are non HEU-based. The proposed legislation
will greatly 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.
The Mo-99 shortages over the last few years are due to both
unforeseen and required maintenance to the aging reactors around the
world that provide the global supply. In May 2009, the fragile supply
chain for Mo-99 was significantly threatened by the unexpected shutdown
of the primary supplier for the U.S. due to a serious maintenance
concern. In 2010, this unexpected supply interruption will be
exacerbated by the required scheduled maintenance of the second largest
global supplier. The Office of Science and Technology Policy of the
Executive Office of the President is directing an Inter-agency working
group, which includes NNSA and other Department of Energy offices, to
investigate 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, and prior to the development of new longer-term
production capabilities. The current Mo-99 shortages are being
mitigated as effectively as possible in the near-term through industry-
wide communication, scheduling and more efficient use of available Mo-
99 supplies, the application of alternate diagnostic technologies and
increased production from all of the global producers. Near-term
production and the significant amount of attention focused to address
this problem needs to be carefully balanced with other efforts to
ensure the development of a long-term reliable supply of non-HEU based
Mo-99. With appropriate Congressional support, the long-term options
could be readily achievable and available for steady state production
with the objective to create a consistent supply of the medical isotope
to health care providers.
The National Academies published a report on January 14, 2009
confirming that the production of Mo-99 without the use of HEU is both
technically and economically feasible. It was the National Academies'
determination that there are ``no technical reasons that adequate
quantities [of medical isotopes] cannot be produced'' without the use
of HEU, and furthermore, that ''. . . the greatest single threat to
supply reliability is the approaching obsolescence of the aging
reactors that large-scale producers utilize to irradiate HEU target to
obtain Mo-99.'' The report positively supports HEU minimization by
establishing that it is feasible for global producers to convert to
LEU, and identifying the risk to the domestic supply reliability.
To address the longer-term production of Mo-99, NNSA is developing
projects to accelerate the establishment of domestic commercial sources
of Mo-99 without HEU. To prevent the single point of failure scenario
facing today's U.S. Mo-99 supply, NNSA is helping demonstrate the
feasibility of non-HEU based Mo-99 production by working with
commercial entities and national laboratories on four technology
pathways. These include: LEU fission technology; LEU solution reactor
technology; neutron capture technology; and accelerator technology. The
goal is for each technology to be commercially successful, and NNSA's
approach is technology neutral. NNSA is working with the one commercial
partner in each of the four areas whose projects on Mo-99 are most
advanced for that technical pathway. NNSA also makes available the
technical expertise of the U.S. national laboratories gained over many
years in the non-HEU based Mo-99 production technologies. The
commercialization of these different non-HEU based technologies
supports the strategy to diversify the Mo-99 supply and move away from
reliance on a sole technology and a limited number of facilities, as is
the case with today's foreign producers.
NNSA is planning to spend approximately $20 million in FY 2010 to
establish these technologies. Funding would come from within the Global
Threat Reduction Initiative budget.
As with any major technology initiative, there are challenges that
could affect the acceleration of these technologies that must be
addressed. We must overcome the technical difficulty involved in
extracting the final medical product and processing it into a form that
meets Food and Drug Administration (FDA) standards, and doing so
steady-state on a commercial scale suitable to meet the needs of the
medical community. The production of this valuable commodity is a
complex endeavor and lessons learned from two experienced commercial-
scale producers that have initiated recent projects to construct new
production capabilities must be considered to minimize difficulties as
we proceed. There are many research reactor operators globally that
contend they can produce Mo-99, but we must not underestimate the
difficulties to be overcome in the process to provide material at the
standards required and on a scale to satisfy global demand. We must
maintain our focus on supporting the demonstration of commercial scale
Mo-99 production by those few specific entities that are most advanced
under the technology-neutral process we have developed. 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.
This legislation will provide the national visibility necessary to
address this critical medical need as rapidly as possible and will also
achieve important nonproliferation goals. I thank Senator Bingaman and
the Committee for your continued leadership by supporting this
legislation.
The Chairman. Thank you very much.
Mr. Crowley, why don't you go right ahead?
STATEMENT OF KEVIN D. CROWLEY, PH.D., SENIOR BOARD DIRECTOR,
NUCLEAR AND RADIATION STUDIES BOARD, NATIONAL RESEARCH COUNCIL,
THE NATIONAL ACADEMIES
Mr. Crowley. All right. Thank you very much.
I would like to use my few minutes just to highlight some
key points from my written testimony, which is in the record.
As you know, section 630 of the Energy Policy Act of 2005
included a mandate for a National Academy of Sciences study to
assess the feasibility of producing medical isotopes without
the use of highly enriched uranium. We completed that study in
late 2008. We issued our report, which is entitled ``Medical
Isotope Production Without Highly Enriched Uranium,'' in
January 2009. Our report focuses on the production of the
medical isotope molybdenum-99, which I will use the short-hand
Mo-99. There are a lot of terms in this business that are very
hard to pronounce.
The Mo-99 is used in over two-thirds of all diagnostic
medical isotope procedures in the United States. There are five
key messages from our report, and I just would like to briefly
summarize those for you.
First, we found no technical barriers to the large-scale
production of Mo-99 without highly enriched uranium. Second, we
estimated that the average cost increase to convert Mo-99
production from highly enriched uranium to low-enriched uranium
would likely be less than 10 percent for most current
producers. Such a cost increase would result in trivial
increases in prices for typical medical isotope procedures.
Third, we estimated that the U.S. demand for Mo-99 is
likely to grow at rates of 3 to 5 percent per year over the
next 5 years, assuming, of course, that adequate supplies of
this isotope are available. Domestic growth will likely
continue over the longer term as the U.S. population ages.
Global demand could grow even more rapidly, especially in
developing countries.
Fourth, we noted that Mo-99 supply disruptions are
impacting the continuity of patient care in the United States
and elsewhere. Supply reliability will continue to be a serious
problem until new supply capacity is brought online.
Fifth, our report identified several steps that medical
isotope producers, the Department of Energy, and others could
take to improve the feasibility of conversion to low-enriched
uranium. Some of these steps are already being taken, as noted
in my written statement.
The American Medical Isotopes Production Act of 2009 would
also implement some of the steps identified in our report. Most
notably, the legislation seeks to address the supply
reliability by providing incentives for the development of
domestic supplies of Mo-99 for medical use. Development of
domestic supplies could help alleviate global shortages and
insulate the United States from future supply disruptions.
The legislation also sends a clear signal of Congress's
intention to phaseout the use of highly enriched uranium for
medical isotope production. This could provide a powerful near-
term incentive for conversion. The legislation's proposed
phase-out period of 7 years, with an additional 4 years if
needed, is largely consistent with our report's suggested
phase-out period of 7 to 10 years.
The legislation's authorization of a fixed appropriation to
support conversion is consistent with our report's suggestion
that Congress provide temporary financial incentives to promote
conversion to low-enriched uranium and development of domestic
supplies.
The legislation would also empower the Secretary of Energy
to provide assistance on the development of fuels, targets, and
processes for domestic production of Mo-99. This is consistent
with our report's suggestion that the Department of Energy make
the considerable technical expertise of its national laboratory
system available to assist producers with conversion-related
research and development.
Then, finally, the uranium lease and take back provision in
the legislation was not discussed in our report. However, such
a provision could serve to promote domestic production by
allowing producers to sidestep the regulatory uncertainties
associated with waste classification and disposition. These
uncertainties were identified in our report as potential
roadblocks to domestic production.
Thank you for the opportunity to testify, and I look
forward to our questions and discussion period.
[The prepared statement of Mr. Crowley follows:]
Prepared Statement of Kevin D. Crowley, Ph.D., Senior Board Director,
Nuclear and Radiation Studies Board, National Research Council, The
National Academies
Good morning Chairman Bingaman and members of the committee, my
name is Kevin Crowley, and I am the director of the National Research
Council's Nuclear and Radiation Studies Board.\1\ I also directed the
National Research Council study entitled Medical Isotope Production
without Highly Enriched Uranium, which is the subject of my testimony
today. This report was completed in late 2008 and released to the
public in January 2009.
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\1\ The National Research Council is the operating arm of the
National Academy of Sciences, National Academy of Engineering, and the
Institute of Medicine of the National Academies, chartered by Congress
in 1863 to advise the government on matters of science and technology.
The Nuclear and Radiation Studies Board is responsible for oversight of
National Research Council studies on safety and security of nuclear
materials and waste.
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My testimony will address the following three topics: the origin of
our medical isotopes study; study charges and principal report
findings; and comments on H.R. 3276 in light of those findings.
study origin
The mandate for this National Research Council study came from
Section 630 of the Energy Policy Act of 2005 (Public Law 109-58).
Section 630 directed the Secretary of Energy to enter into an
arrangement with the National Academy of Sciences for a study on the
elimination of highly enriched uranium (HEU\2\) from reactor fuel,
reactor targets, and medical isotope production facilities. Our study
focused on the production and use of molybdenum 99 because its decay
product, technetium 99m, is used in over twothirds of all diagnostic
medical isotope procedures in the United States. Our report concluded
that the production of molybdenum 99 in quantities sufficient to meet
current healthcare needs would ensure that other reactor-produced
medical isotopes (such as iodine and xenon) would also be available in
sufficient quantities.
---------------------------------------------------------------------------
\2\ HEU is defined as uranium enriched in the isotope uranium 235
to levels greater than or equal to 20 percent. The United States
supplies most of the HEU that is used to produce medical isotopes
worldwide.
---------------------------------------------------------------------------
The congressional mandate for our study arose because of a conflict
between the Energy Policy Act of 1992, which created increasing
pressure to phase out U.S. exports of HEU for reactor fuels and
targets, and the Energy Policy Act of 2005, which sought to increase
the reliability of medical isotope supply by lifting the requirements
of the 1992 Act for HEU exports to Belgium, Canada, France, Germany,
and the Netherlands for medical isotope production.
study charges and principal findings
Our study had five charges, the first four of which were specified
in the 2005 Act; the last charge was negotiated with the study sponsor,
the National Nuclear Security Administration, to assist it in achieving
its mandate to minimize HEU use in civilian applications. The study
charges and some principal findings are summarized below.
Charge 1: Determine the feasibility of procuring supplies of
medical isotopes from commercial sources that do not use HEU.
We found that, at the present time, there are not sufficient
quantities of medical isotopes produced without HEU to meet
U.S. domestic needs. However, we also found no technical reason
that adequate quantities could not be produced using low
enriched uranium (LEU\3\) targets. Our report noted that
Argentina and Australia are now producing molybdenum 99 with
LEU targets. These countries are producing primarily for
domestic and regional needs, but they are exploring
opportunities to become global suppliers.
---------------------------------------------------------------------------
\3\ LEU is uranium enriched in the isotope uranium 235 to less than
20 percent.
Charge 2: Determine the current and projected demand and
availability of medical isotopes in regular current domestic
use. We found that the U.S. demand for molybdenum 99 is about
5,000-7,000 6-day curies per week,\4\ which is about half of
the global demand for this isotope. We also found that domestic
demand for this isotope is likely to grow at rates of 3-5
percent per year over the next 5 years, and that growth will
likely continue over the longer term as the U.S. population
ages. The global demand for this isotope could grow even more
rapidly in the years ahead as nuclear medicine technologies
find more widespread application, especially in developing
countries. Robust international growth could impact future
domestic molybdenum 99 supply, availability, and price because
the United States does not produce this isotope for medical
use.
---------------------------------------------------------------------------
\4\ A 6-day curie is a measure of the quantity of molybdenum 99
present 6 days after it leaves a producer's facility. Time calibration
is necessary because the quantity of molybdenum 99 decreases by about 1
percent per hour as a result of radioactive decay.
---------------------------------------------------------------------------
Global molybdenum 99 production is insufficient to meet
current demand owing to the recent shutdowns of two reactors:
The NRU Reactor in Canada and HFR in the Netherlands. These
reactors are 52 and 48 years old, respectively, and are likely
nearing the ends of their operating lifetimes. The supply
disruptions arising from these reactor shutdowns are impacting
the availability of molybdenum 99 for medical use and the
continuity of patient care in the United States and elsewhere.
Supply reliability is likely to continue to be a serious
problem for the United States until new supply capacity is
brought online.
Charge 3: Determine the progress being made by the Department
of Energy and others to eliminate all use of HEU in reactor
fuel, reactor targets, and medical isotope production
facilities. The U.S. Department of Energy (DOE) is leading the
Global Threat Reduction Initiative (GTRI), which is working to
convert reactor fuel and targets from HEU to LEU. Our report
found that DOE has made substantial progress in converting
reactor fuel and targets through the GTRI. We recommended that
DOE determine the feasibility of converting 78 HEU-fueled
research and test reactors that are currently out of scope of
the GTRI program, and also that DOE increase its focus on
eliminating the HEU wastes that result from medical isotope
production.
Our report notes that molybdenum 99 producers have been slow
to adopt the LEUbased production processes that have been
developed by DOE and others. This is likely because producers
have no good business reason for converting to LEU-based
production: they would realize little or no direct revenue
benefit from conversion, as conversion would not enhance
product quality, nor would it reduce the production costs. In
fact, we saw no evidence during our study that large-scale
producers were doing the necessary research and development
work to support conversion to LEU-based production.
Charge 4: Determine the potential cost differential in
medical isotope production in reactors and target processing
facilities if the products were derived from production systems
that do not involve fuels and targets with HEU. We found that
the anticipated average cost increase to convert to the
production of medical isotopes without the use of HEU would
likely be less than 10 percent for most current large-scale
producers given a sufficiently long amortization period. This
finding was based on a conservative present value cost analysis
at three steps in the molybdenum 99/technetium 99m supply
chain: production of molybdenum 99, production of technetium
generators, and delivery of technetium 99m doses. In fact, we
concluded that a 10 percent increase in price at any of these
three points in the supply chain would result in a trivial (< 1
percent) increase in the price of a typical medical isotope
procedure.
Charge 5: Identify additional steps that could be taken by
DOE and medical isotope producers to improve the feasibility of
conversion to LEU-based isotope production processes. We
identified additional steps that could be taken by DOE and
others to improve the feasibility of conversion of medical
isotope production. We specifically suggested that:
Producers should commit to conversion and announce a best-
effort schedule for eliminating HEU-based production.
DOE should make the considerable technical expertise of the
national laboratory system available to assist producers with
conversion-related research and development.
The Department of State should intensify the diplomatic
pressure on countries that still use HEU to induce them to
convert.
The Food and Drug Administration (FDA) should work with
industry and technical experts to ensure that there is a common
understanding of likely FDA requirements for obtaining
regulatory approvals for the medical use of LEUbased molybdenum
99/technetium 99m.
The U.S. Congress should provide clear and consistent policy
directions concerning conversion to LEU-based molybdenum 99
production; consider a gradual phaseout of HEU exports for
medical isotope production; and consider incentives to motivate
conversion and the development of domestic sources of
molybdenum 99 production.
Notable progress has been made in implementing these suggestions
since our report was published: DOE has offered technical assistance to
medical isotope producers; the FDA acted promptly to approve the
domestic sale of radiopharmaceuticals containing technetium 99m from
Australia and South Africa; Mallinckrodt and Babcock and Wilcox have
announced a partnership to produce molybdenum 99 using an LEU solution
reactor; and the South African producer NTP recently announced that it
would convert its medical isotope production process to LEU targets.
comments on h.r. 3276
The American Medical Isotopes Production Act of 2009 is responsive
to many of the findings from our report. Notably, the legislation seeks
to address the chronic supply reliability problem by providing
incentives for the development of domestic supplies of molybdenum 99
for medical use. Development of a domestic supply of molybdenum 99
could help alleviate current global shortages and insulate the United
States from future supply disruptions. It could also help to ensure the
continued availability of this workhorse isotope to meet future
domestic demand if, as expected, the global demand for this isotope
continues to grow.
The legislation sends a clear policy signal of Congress' intention
to phase out HEU for medical isotope production; this signal could
provide a powerful near-term incentive for conversion. The
legislation's proposed phase-out period of 7 years, with an additional
4 years if needed, is largely consistent with our report's suggested
phase-out period of 7-10 years. We judged that 7-10 years would be
sufficient for producers to make an orderly conversion to LEU-based
production. This judgment was based on previous experiences with
conversion and our understanding of regulatory processes.
The legislation's authorization of appropriations to develop a
domestic supply capacity for medical isotope production is consistent
with our report's suggestion that Congress provide temporary financial
incentives for conversion to LEU-based production and development of
domestic supplies. Our report notes that ``because current supplies of
Mo-99 are produced in reactors built largely at government expense,
private companies that can provide new domestic supplies of [molybdenum
99] might not choose to compete without government assistance.''
The uranium lease and take back provision in the legislation was
not specifically identified as an incentive in our report. However, it
could serve to promote domestic production by allowing producers to
sidestep the regulatory uncertainties associated with waste
classification and disposition.
Finally, the legislation would empower the Secretary of Energy to
provide assistance for the development of fuels, targets, and processes
for domestic production of molybdenum 99. This is consistent with our
report's suggestion that the Department of Energy make the technical
expertise of the DOE national laboratory system available to assist
producers with conversion-related research and development.
This concludes my testimony to the committee. I would be pleased to
answer your questions.
The Chairman. Thank you very much.
Mr. Brown.
STATEMENT OF ROY BROWN, FEDERAL AFFAIRS SENIOR DIRECTOR,
COUNCIL ON RADIONUCLIDES AND RADIOPHARMACEUTICALS (CORAR), ST.
LOUIS, MO
Mr. Brown. Good morning, Mr. Chairman, Ms. Murkowski,
members of the committee, and staff. My name is Roy Brown, and
I am Senior Director of Federal Affairs for the Council on
Radionuclides and Radiopharmaceuticals, or CORAR.
I am here today to testify on the American Medical Isotopes
Act of 2009 on behalf of CORAR and to answer questions from the
committee.
CORAR supports H.R. 3276 and the provisions contained in
the legislation. We believe this legislation will provide
important funding, waste disposal, and regulatory support to
help establish reliable medical isotope production in the U.S.
This legislation is an important step toward a reliable
source of these medical radionuclides for our patients and will
contribute to enhancing supply well into the future. More than
40,000 patients each day in the U.S. rely on technetium-99m to
provide detection of heart disease or for early detection and
staging of cancer, all of which can reduce healthcare cost and
improve the quality of life.
As a supporter of H.R. 3276, 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 the U.S. patients.
First, Section 3(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 is no
disposal pathway available in the U.S. for the types of
radioactive waste generated.
The waste will be produced at new medical isotope
production facilities. It is critically important DOE accepts
this radioactive waste at reasonable prices. This will help
assure new medical isotope production facilities can be built
and operated effectively.
Second, 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 FDA, the DOT, the EPA, as well as
State and local regulatory agencies. We are concerned that
acceptance of money from DOE for the development of medical
isotope capability under this legislation may trigger
duplicative National Environmental Policy Act 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. We would like to see a provision in the legislation for
any Federal money spent on the development of medical isotopes
not be burdened by duplicative regulatory constraints.
Third, several groups are working on the development of new
types of isotope production reactors or have plans to convert
existing reactors for more efficient 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 language in Section 104 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 H.R. 3276 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
licensing of these reactors under Section 104 of the AEA. If
assistance of this type could be included in this legislation,
it would help expedite the licensing of these new reactors and
bring these new sources of Mo-99 to market more quickly.
Last, CORAR is aware of several promising efforts to
develop new medical isotope production techniques. We believe
these efforts are worthy of funding from this legislation. We
also feel the American public can best be served by developing
several efforts concurrently rather than backing only one or
two of these efforts.
Given the legislation's intent to broadly serve American
patients, funding should be directed to projects which stand
the best chance of producing commercially meaningful quantities
of medical isotopes. 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
decisionmaking process for these projects.
Thank you for the opportunity to testify here today. CORAR
supports 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 crisis for the benefit of the
American patients.
I would be happy to answer any questions the committee may
have.
[The prepared statement of Mr. Brown follows:]
Prepared Statement of Roy Brown, Federal Affairs Senior Director,
Council on Radionuclides and Radiopharmaceuticals (CORAR), St. Louis,
MO
CORAR\1\ (Council on Radionuclides and Radiopharmaceuticals)
supports H.R. 3276 and the provisions contained in the legislation. We
believe this legislation will provide important funding, waste disposal
and regulatory support to help establish reliable medical isotope
production in the United States. The current medical isotope crisis has
affected thousands of American patients who rely on these products
every day for diagnosis, treatment planning and treatment. CORAR
supports H.R. 3276 because it is an important step towards a stable
source of these medical radionuclides for our patients and will
contribute to enhancing supply well into the future.
---------------------------------------------------------------------------
\1\ 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. Several of CORAR's members are
the primary processors of Mo-99, or are manufacturers of Tc-99m
generators which use Mo-99.
---------------------------------------------------------------------------
As a supporter of H.R. 3276, CORAR would like to highlight a few
issues for the committee's consideration to ensure that the bill will
accomplish its goals and serve the medical needs of US patients:
Assure DOE accepts radioactive waste generated as a result
of medical isotope production at reasonable prices.
Develop a regulatory framework in which the funding from the
legislation can be distributed to worthwhile efforts without
triggering duplicative regulatory reviews.
Direct the Nuclear Regulatory Commission to develop a
regulatory space to allow for the licensing of new medical
isotope production reactors that do not have to be licensed as
power reactors.
Direct DOE to develop a process for the fair and technology-
neutral administration of funds created in this legislation
with appropriate input from industry.
CORAR would like to continue working with staff to determine the
best way to address these concerns for the benefit of American
patients.
i. introduction
Mo-99 and Tc-99m play an important role in healthcare. The use of
medical radionuclides is very important today--these compounds help
provide early detection and treatment of diseases which can reduce
health care costs and improve quality of life. There are more than 100
different nuclear medicine procedures in use today, of which more than
16 million nuclear medicine procedures performed each year in the U.S.
Of these, 41,000 use Tc-99m each day. Roughly 95% of the medical
radionuclides used in nuclear medicine are produced using HEU targets
in nuclear reactors. The majority of nuclear medicine procedures are
for diagnostic imaging, but there are also many therapeutic nuclear
medicine treatments including Non-Hodgkin's Lymphoma, Liver Cancer, and
Thyroid Cancer and for bone pain palliation related to Prostate Cancer.
Over the last few decades more than 90% of the Mo-99, (Iodine) I-
131, I-125 and (Xenon) Xe-133 that was used in the U.S. came primarily
from just two government owned reactors. Those two reactors are the NRU
reactor operated by AECL in Chalk River, Ontario, Canada and the HFR
reactor operated by NRG on behalf of the European Union in Petten, The
Netherlands. Until recently, these two reactors had been extremely
reliable. However, NRU and HFR were commissioned in 1957 and 1961,
respectively. The age of these reactors has led to age-related
operating problems. NRU has been shut down since May while repairs are
being made to the reactor vessel and is not expected to be back on-line
until early 2010. HFR was recently shut down for a month for routine
maintenance and is scheduled to be shut down again in early 2010 for
several months while repairs are made to its cooling lines. These
planned and unplanned shutdowns have created the current shortage of
Mo-99. Both of these reactors operate with Low Enriched Uranium (LEU)
fuel and HEU targets.
Currently, many efforts are underway to alleviate the Mo-99
shortage, which can reach crisis proportions when both reactors are out
of service. These efforts are coming from governments, industry, and
professional societies around the world. CORAR believes the primary
focus of this new legislation should be to address the need for a
longer term and sustainable solution to this problem. It should also
provide a framework so that similar crises can be avoided in the
future. CORAR has identified six needs that any long term solution
should address or solve, including:
Appropriate site security
Reactor and isotope processing in proximity to each other
Disposal path for the processing radioactive by-products
must be defined and approved
The manufacturing and processing sites should have good
access to a well developed transportation network
The reactor operation must use both LEU fuel and targets
Knowledgeable and empathetic regulatory environment
ii. discussion of specific issues
CORAR is supportive of this legislation. We feel with some minor
modifications and assistance from the Senate this bill can be extremely
effective in creating additional medical isotope capacity. These issues
are elaborated below.
DOE Disposal of Medical Isotope Waste
The production of medical isotopes generates Class A and Class B
low level radioactive waste, and transuranic waste. Currently Mo-99 and
other medical isotopes are being produced outside the U.S. and the
local governments assist these facility operators in the disposal of
that waste. For some radioactive waste in the U.S., there is currently
no disposal pathway available. DOE has waste disposal facilities for
all types of radioactive waste, but it is only available to the DOE.
The legislation appropriately has a provision (Sec 3, (c)) for waste
acceptance by the DOE. Our industry has worked with the DOE for many
years, and as such we are aware of non-competitively high prices DOE
charges for certain services and work performed for others. What we
seek is an understanding that the DOE will accept radioactive waste at
reasonable prices. We seek your guidance in assuring this happens, as
unreasonable disposal charges would inhibit implementation of this
legislation's goals.
Avoiding Duplicative Regulatory Review
For example, we are concerned 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. If NEPA is triggered and the DOE is required to complete
Environmental Impact Statements (EIS) and/or Environmental Assessments
(EA), it will cause significant delays in the development of these
facilities which is counterproductive to the intent of the legislation.
We feel the development of EAs and EISs is not necessary because of
other regulatory controls these facilities will be under. Any new
reactor funded under this legislation will be required to be licensed
by the NRC. The NRC has a comprehensive regulatory framework for
protection of the environment, workers and the public. This regulatory
framework will adequately fulfill the intent of the NEPA and will
protect the environment. Any new production facility receiving funding
under this legislation will be licensed by the NRC or equivalent
Agreement State agency. The NRC and the Agreement States also have the
material program regulatory framework to protect the environment,
workers and the public. Various aspects and operations of these
facilities will also be regulated by the Food & Drug Administration,
Department of Transportation and the Environmental Protection Agency,
as well as state and local regulatory agencies. With these various
levels of regulatory oversight, we do not believe the NEPA will offer
any more protection of the environment. We would like to see a
provision in the legislation for any federal money spent on the
development of medical isotopes to be exempt from the requirements of
NEPA.
NRC Licensing of New Isotope Production Reactors
Several groups are working on the development of new types of
isotope production reactors which fall into a licensing gap at the NRC.
These new types of reactors are being built in the U.S. and will
utilize LEU fuel. 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. At the time the AEA was written, the use of these types of
reactors for the production of medical isotopes was not envisioned.
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. Consequently, these types of reactors
fall into a licensing gap for the NRC. CORAR would like to see H.R.
3276 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.
Distribution of Funds Under this Legislation
CORAR believes NNSA at DOE is the logical administrator of funds
identified in this legislation. NNSA has been closely involved in the
development of LEU--based medical isotope production for many years.
CORAR is aware of several promising efforts to develop new medical
isotope capacity. We believe these efforts are worthy of funding from
this legislation. We also feel the American public can best be served
by developing several efforts concurrently rather than only backing one
or two of these efforts. CORAR positively notes that the legislation
does not limit the number of projects eligible for funding support
provided the projects meet the legislation's criteria related to
ability to meet the legislation's deadlines, capacity to fulfill
domestic Mo-99 demand and cost. For example, given the legislation's
intent to broadly serve American patients, funding should be directed
to projects which stand a good chance of producing commercially
meaningful quantities of medical isotopes. 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 decision-
making process for these projects. The best process will be one that is
technology-neutral and does not pre-judge these development efforts.
iii. other important medical radionuclides
There are other medical radionuclides which are very important to
nuclear medicine. Many of these radionuclides are used in therapeutic
procedures for the treatment of cancer and other illnesses. Although
their number of procedures do not come close to the annual usage of Tc-
99m, they are also very important. These radionuclides can be produced
in a fission reaction such as Mo-99, or they can be produced through
neutron activation. The same reactors that produce Mo-99 also produce
these other radionuclides including I-131, I-125, Xe-133. These
radionuclides are used in diagnostic and therapeutic procedures and are
being examined for use in exciting new products for nuclear medicine.
It is important to remember these other radionuclides play an important
role in the practice of nuclear medicine and should be included in the
overall approach to assuring a reliable supply for critical medical
radioisotopes.
iv. conclusion
The current worldwide shortage of Mo-99 has illustrated the
fragility of supply and the need for additional medical radionuclide
production. CORAR is supportive of H.R. 3276 and increasing the
capacity for medical radionuclides in the U.S. We believe several key
issues still need to be addressed in the legislation to assure it will
provide the best environment to develop additional medical isotope
production capacity.
By assuring DOE accepts all radioactive waste generated as a result
of medical isotope production at reasonable rates, the new production
facilities being developed will be economically viable.
Developing a regulatory framework in which the funding from this
legislation can be distributed to worthwhile efforts without triggering
duplicative regulatory reviews, such as National Environmental Policy
Act (NEPA), will assure the new facilities will come on-line more
quickly without compromising the environment or protection of workers
or the public.
Directing the Nuclear Regulatory Commission to develop a regulatory
space to allow for the licensing of new medical isotope production
reactors that do not have to be licensed as power reactors will bring
these facilities on-line more quickly, and at a lower cost. Reactors
dedicated solely to medical isotope production were not envisioned when
the Atomic Energy Act was first written in 1954.
Directing DOE to develop a process for technology-neutral
administration of funds created in this legislation with appropriate
input from industry will help assure the fair and most productive use
of these funds. CORAR believes it is prudent to back several
alternative technologies capable of producing significant quantities
and multiple reactor sites in order to avoid a repeat of the current
availability and capacity issues.
As H.R. 3276 moves forward, CORAR hopes to continue to work with
the Committee and staff to ensure both a swift and long term solution
to the medical isotope crisis. Thank you for the consideration of our
perspective. CORAR looks forward to working with you toward the
enactment of this legislation.
The Chairman. Thank you very much. Thank all of you for
your testimony.
Let me just ask a few questions. First, Dr. Staples, what
are the potential reactors here in the U.S. that might be used
for LEU-based medical isotope production?
Mr. Staples. Generally, large-scale quantities of LEU
target-based Mo-99 production require a research reactor that
operates on a steady state with a short operating cycle and can
dedicate operating time to Mo-99 production. Typically, the
current international producers have a minimum of 10 megawatts
of power for production.
So I would actually like to take the question for the
record so that I can actually convey this list to you properly.
It actually does have the list of reactors in the U.S. and
internationally that are producing isotope.
[The information referred to follows:]
The attached chart entitled ``Research Reactor Capability''
includes the research reactors at U.S. universities, U.S. Government
facilities, and major foreign producers and potential producers, with
the associated power levels. It should be noted there are three main
considerations that are helpful when examining this chart.
First, research reactors require high levels of neutron flux to
produce medical isotopes efficiently. The six major producers (denoted
in the chart by asterisks) have significantly higher thermal power than
any of the U.S. university reactors. To a first approximation,
production capacity for fission target-based production of radio-
isotopes scales with reactor power.
Second, utilizing the U.S. Government facilities for medical
isotope production would be technically challenging, expensive, and
would impact other important missions of those facilities. The U.S.
Interagency Working Group led by the Office of Science and Technology
Policy (OSTP) evaluated the potential use of two U.S. Government
reactors (ATR and HFIR) for irradiation of Highly Enriched Uranium
(HEU) targets to alleviate the short-term shortage. However, the
analysis of these alternatives has shown them to be very expensive,
technically challenging and, despite the effort that would be entailed,
providing only a small fraction of the U.S. demand for Mo-99. These
reactors also provide critical services to other customers, including
national security missions that may be hindered if the facilities were
devoted to Mo-99 production.
Finally, NNSA's efforts to establish a reliable non-HEU domestic
source of Mo-99 in the long-term have eliminated U.S. Government
facilities or its contractor facilities as possible providers since the
intent is to establish a commercially viable market. To that end, it
would be inappropriate for the U.S. Government organizations to compete
with these commercial entities.
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
But to quickly answer your question, there are several
larger reactors in the U.S. that can operate. There are some
DOE facilities, which we would not necessarily consider a DOE
facility to be a primary source of irradiation for this
production because of the noncommercial nature of those
facilities, which would be the HFIR reactor at Oak Ridge
National Laboratory. The ATR reactor is also a large research
reactor that is located at Idaho National Laboratory, and then
we have several university reactors, such as the University of
Missouri, which is a 10-megawatt facility. Massachusetts
Institute of Technology is a 5-megawatt facility.
Then there are a number of other facilities that have
anywhere from 1 to 2 megawatts of operating power but are
probably on the small side for regular large-scale commercial
production.
The Chairman. All right. Dr. Crowley, I think you mentioned
in your testimony the use of accelerators rather than reactors
to produce these isotopes. Do you think that accelerators can
produce the volume of Mo-99 that is required here in this
country?
Mr. Crowley. The short answer to your question is no, and
let me explain why the answer is no. The reason that reactors
are used to produce Mo-99 is that they provide very high fluxes
of neutrons. If you imagine a postage stamp, which is about
between half an inch and an inch on a side, if you put that
postage stamp into the reactor, every second about 100 trillion
neutrons would go through that postage stamp. So that is a very
high flux of neutrons, which is what you need to fission the
uranium-235 to produce the Mo-99.
You don't get those sorts of high fluxes with accelerators.
You would have to build a lot of accelerators. It would be very
expensive to get an equivalent production.
The other advantage of the reactors over the accelerators
is that the reactors tend to be multipurpose, multiuse
facilities. So you can be producing Mo-99, but at the same
time, you can be irradiating other materials and you can be
conducting scientific experiments. With an accelerator, it
would be a dedicated facility simply to produce Mo-99.
The estimates that I have heard for accelerator-based
production of Mo-99 would be on the order of hundreds of 6-day
curies per week. Six-day curies is the measure that we
typically use of Mo-999 quantity. The current U.S. demand is
between 5,000 and 7,000, 6-day curies per week. So an
accelerator could produce hundreds of curies, but we demand
thousands of curies per week.
The Chairman. All right. Let me ask you, Mr. Brown, in your
testimony you indicate that the department's fuel takeback
charges could be unreasonable. What is the mechanism that you
would propose to ensure that these charges are reasonable while
still having the industry bear the burden that is called for in
the legislation to pay for the ultimate disposal?
Is there some way to accomplish both of those objectives?
Mr. Brown. Our industry has quite a bit of experience
working with the DOE and the national labs. Our experience has
been that quite often charges working with the national lab are
much, much higher than you would normally pay on a commercial
basis, often several times higher, 3 to 4 times higher than the
actual cost of that.
So we are concerned about paying more than commercially
available rates for disposing of this waste. We realize that
some of this waste there currently is no disposal. So to
compare a commercial price for waste you can't get rid of
anywhere else is difficult, but we would expect something on
the order of what we would pay commercial charges for.
The Chairman. OK. Why don't I stop with that and call on
Senator Murkowski?
Senator Murkowski. Thank you, Mr. Chairman.
Several of you, actually I think all of you have mentioned
the importance of the legislation being technology neutral in
making sure that we are not favoring reactors over accelerators
or other neutron-capture technology.
Mr. Brown, you mentioned that certain types of these
production reactors fall within this ``licensing gap'' because
they are not research or power reactors and have suggested that
perhaps we might need some clarification to spell out whether
or not it is a production reactor.
If we do that, do we then edge up against the concern that
the legislation is not technology neutral? I guess a broader
question to the panel would be how important is it to ensure
that it is technology neutral?
Mr. Brown. Our specific concern about the NRC licensing gap
is based on the fact that when the Atomic Energy Act was
written in 1954, it really wasn't envisioned that there would
be reactors that are out there producing medical isotopes that
were not commercial reactors and they are not research
reactors.
So that the difficulty we are in is some of these new
reactors that are being considered, the NRC is coming back and
saying we think they can be licensed under Section 103, which
is the section of the Atomic Energy Act that deals with
commercial reactors, commercial nuclear power reactors.
However, these reactors for medical isotope production are
inherently safe, and we don't feel that they should be licensed
under that with the more stringent requirements of a nuclear
power reactor.
So the problem of the licensing gap is a little bit
different. So we are just hoping that some of the provisions
that are usually used for research reactors can be applied to
these new medical isotope reactors.
Senator Murkowski. Can somebody provide a clear
understanding in terms of what our options in the United States
may be for meeting the demand for the medical isotopes next
year and recognizing what is happening with the facility in
Canada? What are our options?
I mean, if you are a physician, do you have to defer
nonemergency procedures? What happens? Any of you may respond.
Mr. Staples. Yes, I will take that question first. In 2
weeks, we are going to a meeting with the Organization for
Economic and Cooperative Development Nuclear Energy Alliance,
where a high-level working group of the current producers will
try to optimize their schedules for production.
In terms of 2010--and actually, again, I will take some of
this question for the record so that I can convey this chart to
you. These are two very important visuals that we have to
demonstrate the message. But from this chart, what you can see
is that the red line of 12,000, 6-day curies is the normal
demand. This is the projected supply cycle for next year. You
can see there are several significant gaps.
[The information referred to follows:]
The attached graph* illustrates our best estimate of what the
projected global Molybdenum-99 (Mo-99) supply availability could be in
2010, assuming the worst-case scenario that the Canadian NRU reactor
does not resume operations as expected in the first quarter of 2010.
Atomic Energy of Canada Limited has committed to returning the NRU to
service as quickly as safely possible and the latest projected date to
return to operation is by the first calendar quarter of 2010, but that
is no means guaranteed. If the NRU returns to operation as expected,
the expected supply shortage in the last three quarters of 2010 would
largely, but not entirely, be resolved. This graph and the associated
supply estimate is also highly speculative regarding the supply of
medical isotopes; it is likely that in practice the shape of the curve
will be different as production schedules and market forces cause
adjustments.
---------------------------------------------------------------------------
* Graph has been retained in committee files.
Senator Murkowski. What creates those significant gaps?
Mr. Staples. The operating schedule of the current
producers, and they do not have any ability to operate
continuously. They have regular refueling and maintenance
operations that they need to undergo. This chart is actually
produced assuming that the Canadian reactor does not come back
into production. If the Canadian reactor comes back in
operations in the first quarter, as the Canadian government is
currently stating and aiming for, there will not be a supply
issue in 2010.
Senator Murkowski. So you will meet that red line?
Mr. Staples. We will be able to meet that red line if the
Canada's NRU resumes operation.
Senator Murkowski. Do we know when the Canadians will be
able to make a decision?
Mr. Staples. We do not. The latest information we had, and
we expect an update at the meeting in 2 weeks, will be at the
first quarter of 2010.
Now the question that you asked regarding if there is a
supply disruption, there really honestly is little that we can
do other than knowing what the current production schedule
looks like, such that doctors can adjust diagnostic tests and
procedures or use alternate diagnostic methods to determine the
treatments that might be appropriate.
Senator Murkowski. The alternate diagnostic methods are not
as efficient or accurate. I am assuming there is good reason
that the demand exists?
Mr. Staples. That is correct. I am not a medical
professional, and I would actually defer to Mr. Brown to fully
answer that question.
Senator Murkowski. I am trying to understand, your graph
from a distance looks very problematic if in fact we have no
control over this, since we are not producing anything in this
country. We are at the mercy of those who are producing, Canada
and others.
As a Nation that consumes 50 percent of these isotopes,
what options do we have, if any? I would like to understand
what we are going to anticipate next year if, in fact, Canada
is not able to come into the supply cycle like we would hope.
Mr. Staples. OK. In addition to adjusting and looking at
alternate treatments and trying to optimize their current
production schedule, which this chart shows an optimized
production schedule. This is not what the producers were
originally planning to produce in 2010.
We have adjusted this to minimize the number of gaps that
are in this chart because the medical community does state that
they would prefer a regular diminished supply rather than an
irregular large supply. So we have tried to smooth over the----
Senator Murkowski. But this looks somewhat jagged.
Mr. Staples. It was worse.
Senator Murkowski. There is some irregularity. It was
worse?
Mr. Staples. It was worse.
Senator Murkowski. OK.
Mr. Staples. It is as best as it can be, given the
requirements and demands of operating the production reactors.
In addition, we have worked under the direction of the OSTP,
Office of Science and Technology Policy of the President, with
the Department of Energy's Office of Science, our Canadian
colleagues, and, in fact, the entire interagency to try to
determine if there are any short-term production options.
We are still under the evaluation phase within the
Department of Energy to determine if there are some short-term
production options. However, they are extremely difficult to
implement from a technical basis, and they are extremely
expensive to implement because the only reliable facility that
we can use for manufacture of the isotope is to use a U.S.-
based reactor and to separate the medical isotope at the
facility in Canada.
So it would require regular transportation of irradiated
targets from the U.S. to Canada and separations in the Canadian
facility for subsequent distribution to the United States.
Senator Murkowski. We don't have the ability or the
capability to do any of the separation here?
Mr. Staples. We do not, not in the timeframe necessary at
the commercial scale necessary with FDA approval. That is the
difficulty. It is not always just having the neutrons to make
the isotope. The actual difficulty in this process is actually
being able to separate the isotope out of the targets and turn
it into a commodity that is approved by the FDA for human
consumption. That really is the difficult part of this process.
Senator Murkowski. Thank you, Mr. Chairman. My time is
expired.
The Chairman. Senator Burr.
Senator Burr. Thank you, Mr. Chairman. Thank you and the
ranking member for holding what I think is a very important
hearing.
I would like to thank our witnesses today for their
expertise. During the debate in 2005 on the Energy Policy Act,
I fought for a provision to allow us to export highly enriched
uranium for the purposes of us getting the medical isotopes we
need in the marketplace, and I say this for my colleagues.
They include the treatment, diagnostic treatment for heart
disease, cancer, lymphoma, Graves' disease, cold infection in
AIDS, Parkinson's disease, Alzheimer's disease, epilepsy, renal
kidney failure, bone infections. The one thing that this tool
provides us is the ability to go to one diagnostic tool and to
have conclusive evidence of where the problem is versus to run
multiple diagnostic tools as you home in on what the problem
might be.
So at this particular time, as we are debating healthcare,
this is an absolutely crucial component of how you save money
in the overall healthcare system, and that is why Mr. Brown I
think is right to focus on a reasonable price. I am not sure
you can pull a number out of the sky except to say here is what
the commercial market offers today and here is what the cost
is.
Now if you put together a matrix that raises the cost three
and four times, two things happen. One, you raise the cost of
healthcare. But two, you put in jeopardy a provider, be that
Medicare or private sector insurer or out of pocket, of the
system saying this isn't cost effective. We would rather do the
other four tests because they come up cheaper than this one.
Yet under that scenario, you might not conclude with finality
what the problem actually is.
So refresh me, Mr. Brown, are radioisotopes used in
contrast imaging?
Mr. Brown. No. Contrast imaging uses nonradioactive drugs.
Senator Burr. OK. I couldn't remember. But contrast imaging
was a great example of how the Federal Government looks at the
advancement of technology and doesn't recognize that
reimbursement plays a large role in whether, in fact, we
incorporate these in the everyday use of medicine.
When contrast imaging came onboard, Centers for Medicare
and Medicaid Services, in an effort to reimburse for this new
technology, decided they would double the reimbursement for
noncontrast imaging to make up for the shortfall for contrast.
Every hospital administrator the next day told the areas of the
hospital they would only do noncontrast imaging from that point
forward because the benefit was they got a reimbursement that
was double.
So I think we fool ourselves if we don't believe that
reimbursements do play a part in how providers ultimately will
use diagnostic tools, and this would be one of them as well.
Let me turn, if I could, to Dr. Staples for a minute. I
agree with you that the quicker we can move to domestic
production, the sooner we can mitigate some of the nuclear
proliferation concerns, which is what we fought for the last
few years. You mentioned that you are working with the industry
on four technology pathways.
Does the NNSA have all the regulatory tools that you
believe are necessary to effectively and efficiently
commercialize those paths?
Mr. Staples. I believe we do, and I think that is the
strength of this legislation is that it would actually give the
recognition through the interagency in the authorization to
ensure that, as the interagency, we come together with the FDA,
the NRC, the EPA to ensure that all of the regulatory
requirements and obligations that are necessary to implement
this technology would actually be implemented in as timely,
expedient manner as possible to meet the needs of the medical
community.
Senator Burr. If, in fact, you--when this is passed--find
that you don't have all the tools, will you come back to us and
share what you need?
Mr. Staples. Absolutely. That is where I think that this
legislation gives the recognition to this important issue, and
that is actually where we appreciate this legislation, that it
brings the high-level attention to resolve this issue. As you
know, this has been a longstanding nonproliferation issue.
Really, with the result of the National Academies study coming
out recently, it gave us the tool to accomplish the
nonproliferation point of this bill.
But then, recently, with the collapse of the current
production industry, it also gives us the ability to move
forward rapidly and as expediently as possible to resolve the
medical crisis that is looming for the community also.
Senator Burr. I appreciate your chart, and I hope my
colleagues realize that thatchart really does demonstrate how
vulnerable we are to not having the resources to provide the
best level of care and diagnostic tools.
Mr. Crowley, with your study now complete, you looked at
several questions, including what the Department of Energy and
medical isotope producers could do to transition from HEU-to
LEU-based isotope production. The National Academy of Science
recommends Congress provide clear policy directions to phaseout
the exportation of HEUs and encourage domestic production of
LEU isotopes. Do you believe H.R. 3276 successfully achieves
that goal?
Mr. Crowley. The answer to that is yes. As I mentioned in
my oral testimony, we had suggested that a 7- to 10-year phase-
out period for export of HEU would provide a very clear policy
signal to producers that they needed to move to LEU production.
The legislation has a 7- to 11-year phase-out. So I think that
is very consistent with the recommendation in our report.
Senator Burr. Great. Great. I thank the chair.
The Chairman. Senator Murkowski, did you have additional
questions?
Senator Murkowski. Very quickly, Mr. Chairman, and this is
probably best directed to you, Dr. Crowley. The National
Academies have estimated that it would take between 9 to 13
years for the construction of a new reactor at a site that
doesn't have a processing facility and assuming a to
6-year construction period.
Are these time estimates consistent with past licensing
with new reactors and new chemical processing facilities. Then,
more specifically, when was the last time that the NRC licensed
a new research reactor?
Mr. Crowley. I will have to----
Senator Murkowski. It has obviously been some time.
Mr. Crowley. Yes. As it turns out, the 1960s were a very
good decade for building research reactors, and if you look at
a lot of the research reactors that are currently in use today,
they were built in the 1960s, early to mid 1960s. The exception
is NRU, which was built in the late 1950s. But if you would
like to put that question to me in a follow-up, I can get you
an answer to that.
Let me go back to your initial question, though, about
construction of new reactors. The 9- to 13-year estimate was
actually based on our observations of what it had taken in the
past to build reactors, and that time period starts from a
conception that says, gee, we would like to build a research
reactor to the time that you turn on the switch.
The actual construction time can be shorter than 9 to 13
years. As an example, the NRG, which is the operator of the HFR
reactor in the Netherlands, which is one of the major producers
in Europe, is proposing to build a replacement reactor for HFR
called the PALLAS reactor. They are to the point now where they
are ready to select a design, and they believe that they can be
online by 2016.
So to the point where they are almost ready to turn dirt or
to have a conceptual design to the time that they are ready to
turn on the switch is considerably less than 9 to 13 years.
Senator Murkowski. Do you know when the last time was that
the NRC licensed a new isotope processing center, facility?
Mr. Crowley. I do not, but I could certainly get that
answer for you as a follow-up.
Senator Murkowski. One last question to you, Dr. Staples.
We have talked about the objective. You have discussed NNSA's
objective for future Mo-99 production, and that is to establish
this domestic supply.
Now I also understand that domestic supply does not
necessarily mean domestic supplier. So the question to you is
whether or not you are aware of any medical isotope producers
in the world who are either privately financed and not
subsidized by a foreign government? Are there any?
Mr. Staples. The last part of that question actually is
very difficult to answer, and I think that is maybe best
embodied in the National Academies report in terms of the
difficulties they had determining the economic situation. But,
no, at this point in time, I am not aware of any facility that
is producing that is not subsidized to some extent by their
respective governments because almost all of the facilities are
operated as State-owned or government-owned research reactor
facilities.
So, in some extent, their fuels, disposition of radioactive
waste are all subsidized, to the best of my knowledge. But we
will follow up as a question for the record to verify.
[The information referred to follows:]
All major global producers are in some way subsidized by their
respective governments. Chapter 3 of the National Academies report
Medical Isotope Production without Highly Enriched Uranium states,
``All of the organizations that currently produce Mo-99 utilize
government-owned research or test reactors to irradiate targets, and
some use government-owned facilities for target processing and Mo-99
recovery.'' Our assumption is that the operations of the government-
owned facilities are funded at least partially by the respective
governments of each major producer.
Senator Murkowski. Considering the objective within the
NNSA for our domestic production, how can we ensure that we
have a domestic supply when we do not have a domestic supplier?
Mr. Staples. Yes, that is actually--I would like to come
back and complete that answer, and it also goes back to the
earlier question you were asking about the reliability of
supply in this chart. What brought it up to this level that is
demonstrated here is all of the foreign producers are in the
process of increasing their production capacity and have been
operating at above normal production capacities for a period of
time and expect to do that through 2010.
Now we are having discussion to some extent or another with
all of the current producers regarding conversion to LEU. I
believe that they have embodied the importance or embraced the
importance of conversion to LEU, and they are trying to work
with us to convert to LEU production.
In addition, when we describe the difference between
commercial domestic supply versus supplier, we are trying to
work to ensure that we have a reliable diverse supply. We have
gotten into this crisis we have because we essentially have a
single point of failure and one basic technology, and it is
through aging infrastructure.
So developing a diverse supply, whether it is domestic or
international based, will ensure that we can receive this
important commodity coming into the medical community here in
the United States. In fact, we ensure reliable global supply by
doing that.
Senator Murkowski. The reliability issue, of course, is
key. When we talk about secure energy supplies, we know that,
today we may be getting oil from Venezuela and they may be our
friends and providing to us, but tomorrow, they may wake up on
the other side of the bed and decide that they don't want to do
that.
In terms of reliability of supply, how much of a
consideration is this as you are looking to achieve the goals
that you are setting out in terms of our domestic sources of
supply?
Mr. Staples. I would say it is very important. Currently,
we are working or we would intend to work that we would develop
four independent technologies, each capable of supplying up to
50 percent of the U.S. demand. Obviously, in theory, that means
that if each of these are successful, we could supply the
global requirement for this isotope.
In reality, these are difficult technologies to implement.
We don't necessarily expect them to be completely successful,
such the final endpoint will be somewhere between having an
oversupply located domestically versus having some supply that
would come into the global market from both U.S.-based and
foreign-based entities that are producing.
So I think diversity is very important and part of our
consideration as we move forward.
Senator Murkowski. Thank you, Mr. Chairman.
The Chairman. Senator Burr, do you have any other
questions?
We thank all of you very much. It has been very
informative, and we will try to move ahead with the
legislation.
Thank you. That will conclude our hearing.
[Whereupon, at 10:46 a.m., the hearing was adjourned.]
APPENDIXES
----------
Appendix I
Responses to Additional Questions
----------
Responses of Parrish Staples to Questions From Senator Murkowski
Question 1. Dr. Staples, the legislation we are considering calls
for a ban on the exportation of Highly Enriched Uranium for the purpose
of medical isotope production after seven years, with the possibility
for a four year extension.
a. Where does the United States currently export HEU to for
medical isotope production?
Answer. The United States exports HEU to Canada for the production
of targets, which are for Mo-99 production. The U.S. also exports HEU
to Belgium for use as fuel in the BR-2 research reactor which has
multiple functions, including the production of Mo-99.
b. Where do the other reactors that provide the United States
with Mo-99 get their Highly Enriched Uranium?
Answer. The other global producers do not share information on the
origin of the HEU used for the production of Mo-99 medical isotopes.
c. Are those reactors considering converting to using LEU
targets?
Answer. The reactors that irradiate targets for Mo-99 production
can convert to irradiating targets of LEU with few, if any,
modifications. Conversion would mainly affect the processing facilities
where the isotope is extracted from the targets. All global producers
of Mo-99 have demonstrated or communicated a willingness to convert to
LEU. In addition, the National Academies report Medical Isotope
Production without Highly Enriched Uranium confirms that converting Mo-
99 production to LEU is technically and economically feasible.
The conversion project for South Africa's Mo-99 processing
facility, operated by NTP Radioisotopes, is in the demonstration phase
and is currently in discussions to receive regulatory approvals to
export LEU-based Mo-99 to the United States.
Belgium's Mo-99 processing facility, operated by the Institute for
Radioelements (IRE), announced an intent to initiate in 2010 a new
project aimed at conversion to LEU.
The Netherlands' Mo-99 processing facility operated by the Nuclear
Research and Consultancy Group (NRG) has received government approval
to construct a new facility that will operate only with LEU fuel and
targets.
It is unclear whether the Canadian Mo-99 processing facility
operated by Atomic Energy of Canada Limited (AECL) will convert to LEU.
However, in the November 20, 2009 report from Canada's Expert Review
Panel on proposals of alternatives for future Canadian Mo-99
production, the panel recommended that any new investment to produce
Mo-99 in Canada should not use HEU.
Question 2. The NRU reactor in Canada is currently licensed to
operate until October 2011, with the possibility for an extension until
2016.
a. After 2016, and possibly much earlier, do you expect
Canada to continue to produce Mo-99?
Answer. Canada is currently evaluating whether to extend the
license to operate the NRU beyond 2011. In the November 20, 2009 report
from Canada's Expert Review Panel on proposals of alternatives for
future Canadian Mo-99 production, the panel recommended that any new
investment to produce Mo-99 in Canada should not use HEU. We are not
aware of any Canadian decisions yet on whether it will continue to
produce Mo-99 beyond 2016.
b. Do you consider HEU exports to Canada to be a
proliferation risk?
Answer. Canada meets and goes beyond the IAEA Guidelines on the
Physical Protection of Nuclear Material and Nuclear Facilities (INFCIRC
225/Rev 4), and thus we consider that such material in Canada is
protected in accordance with the currently-accepted international
standards. The Nuclear Regulatory Commission has issued export licenses
of HEU to Canada, after determining that the proposed export is not
inimical to the common defense and security of the United States.
Nevertheless, U.S. policy aims to eliminate the use of HEU in civilian
applications to the greatest extent feasible, so as to further reduce
any risk of such materials falling into the wrong hands.
Question 3. If conditions relating to the supply of Mo-99 are the
same six years down the road as they are today, would it be your
analysis that the requirements provided in the legislation for an
extension of the exportation of HEU are met and the extension should be
granted?
Answer. If conditions relating to the supply of and need for Mo-99
are the same six years down the road as they are today, the United
States would be experiencing what most in the medical community
currently consider a critical shortfall of supply. If H.R. 3276 is
enacted as it is written today, and if HEU exports were halted for Mo-
99 production while the United States experiences a critical shortfall
of supply, the Secretary of Energy would decide whether to certify to
Congress, in accordance with the provisions of the legislation, that
there is an insufficient supply of Mo-99, and that the temporary export
of HEU is required to increase the supply to the U.S. market. Because
the Department would make a comprehensive and thorough analysis of the
market and the need for medical isotopes, we cannot speculate on
whether an analysis of a medical isotope shortage similar to what the
United States is experiencing today would result in such a
certification from the Secretary.
Question 4. Is there any legal authority contained in the American
Medical Isotope Production Act that you do not already have?
Answer. DOE has been utilizing existing appropriations and
authorities to support the development of commercial isotope production
technologies. The American Medical Isotopes Production Act of 2009
(H.R. 3276) would provide long-term authorization for funding for this
effort and, as a result, demonstrate U.S. leadership and commitment to
address the objectives of minimizing the commercial use of HEU in the
production of medical isotopes and of promoting the establishment of a
reliable domestic isotope production capability. H.R. 3276 would also
support our HEU minimization policy by creating a set of deadlines and
criteria on the further export of HEU for medical isotope production,
although greater Presidential flexibility is desired in this respect.
Question 5. At current world production levels, how long would it
take to accumulate enough of the radioactive waste product that is left
over after Mo-99 is extracted from the HEU targets to build a nuclear
weapon?
Answer. The National Academies report Medical Isotope Production
without Highly Enriched Uranium states that approximately 50 kg/year of
fresh HEU is utilized for medical isotope production among all of the
global producers. Since the burn up is negligible, about 97% of the
original HEU is still present in the waste, and its enrichment in the
U-235 isotope remains close to the original enrichment, which for most
producers is above 90%. The International Atomic Energy Agency defines
a ``significant quantity'' of HEU with respect to producing a nuclear
explosive device as 25 kgs of contained U-235. This means the wastes
attributed to global medical isotope production accumulate one IAEA
``significant quantity'' of HEU every six or seven months.
Question 6. I understand that the NNSA's objective for future Mo-99
production is to establish a domestic supply of 3,000 6-day curies per
week. I also understand that domestic supply does not necessarily mean
domestic supplier.
a. Are you aware of any medical isotope producer in the world
who is privately financed and not subsidized by a foreign
government?
b. Do you believe a foreign government subsidized business
entity would or could guarantee a supply of medical isotopes to
the United States if there were a shortage in its country of
domicile?
c. If not, how would it be possible to ensure a domestic
supply that is not from a domestic supplier?
Answer. All major global producers of Mo-99 are in some way
subsidized by their respective governments. Chapter 3 of the National
Academies report Medical Isotope Production without Highly Enriched
Uranium states ``All of the organizations that currently produce Mo-99
utilize government-owned research or test reactors to irradiate
targets, and some use government-owned facilities for target processing
and Mo-99 recovery.'' In addition, the European Commission's
Preliminary Report on the Supply of Radioisotopes, page 54, released on
October 30, 2009, states: ``All the major producers of radioisotopes
use research reactors that have been partly or totally built with
government funding.''
NNSA is unaware of any mechanism whereby a foreign government
subsidized business entity would or could guarantee a supply to the
United States if there were a shortage in its country of domicile.
H.R. 3276 would promote the establishment of a domestic production
infrastructure capable of providing enough Mo-99 medical isotopes to
meet domestic needs. To date, NNSA's support for the production of
medical isotopes has focused on developing reliable sources of Mo-99
within the United States. This support does not limit the United States
from continuing to import foreign supplies of Mo-99.
It is also important to note that if H.R. 3276 is enacted, NNSA
would continue its work to assist foreign Mo-99 medical isotope
producers in converting from the use of HEU to LEU. These conversion
efforts have the dual-benefit of HEU minimization and increased
diversification of supplies of non-HEU-based Mo-99 available for the
U.S. and global markets.
Question 7. Is there a situation in which the lack of supply of
Molly-99 would force the NNSA to consider using DOE-owned reactors for
production of Molly-99? What are the procedures and processes that
would be utilized by the NNSA for making such a recommendation? What
are the criteria that would be used for such a recommendation in terms
of Molly-99 supply? Does the NNSA have the authority to require the
production of Molly-99 from DOE-owned nuclear reactors?
Answer. In response to the recent shutdown of the NRU reactor, the
United States and Canada reviewed alternatives for producing Mo-99 in
the short-term. The Canada-U.S. Bilateral Working Group on Backup
Arrangements for the Supply of Mo-99 was established and chartered to
evaluate alternatives for short-term production using some DOE and some
Canadian facilities. The criteria for the evaluation included such
considerations as yield, cost, time impact on displaced projects, and
operational requirements.
The Canada-U.S. Bilateral Working Group on Backup Arrangements for
the Supply of Mo-99 submitted its results to the Governments of the
United States and Canada for consideration in September 2009. In the
United States, the information was reviewed by the Administration for a
determination on next steps, including whether to utilize a DOE-owned
facility for Mo-99 production. Faced with similar circumstances in the
future, the process could be handled in a similar way by establishing a
working group to evaluate alternatives with similar criteria for review
by decision makers.
Question 8. You indicated that an interagency process would be
utilized to streamline the regulatory process for development and
licensing of facilities for Molly-99 production.
a. Have the lines of responsibility for licensing activities
been established?
Answer. The lines of responsibility among agencies for licensing
activities are well established and will not differ from routine
procedures.
b. If so, what are the responsibilities for each agency
involved in the process including DOE, the NRC, and the FDA?
Answer. NRC is responsible for licensing commercial entities that
engage in the production or utilization of nuclear materials. FDA is
responsible for ensuring that radioactive medical products are safe for
human recipients. DOE would support the development of domestic
commercial capabilities to produce Mo-99 without the use of HEU by
providing financial and technical resources.
Responses of Parrish Staples to Questions From Senator Cantwell
Question 1. I share your concern about the global shortage of
Molybdenum-99 and our nation's lack of domestic production and am
encouraged by provisions in the American Medical Isotope Production
Act. I am particularly supportive of its effort to decrease our
reliance on foreign production of Mo-99 and reduce the threat of Highly
Enriched Uranium (HEU) falling into the wrong hands by transitioning to
domestic production of Mo-99 fueled by Low Enriched Uranium (LEU).
However, even if this bill were enacted today, the transition to LEU
would take several years. What is the Department of Energy doing in the
meantime to speed this transition? Are there any US research reactors
that have already converted to LEU fuel that are capable of producing
Mo-99?
Question 2. If yes, would these reactors be able to achieve
commercial production by 2013, the commercial capacity goal expressed
by the National Nuclear Security Administration?
Question 3. What steps are currently being taken by the Department
of Energy and the National Nuclear Security Administration to spur
domestic production of Mo-99? How is the NNSA taking advantage of
reactors that have already converted to LEU?
Answers 1-3. All U.S. research reactors that use HEU have
demonstrated or communicated a willingness to convert to LEU fuel. In
addition, the National Academies report Medical Isotope Production
without Highly Enriched Uranium confirms that converting Mo-99
production to LEU is technically and economically feasible.
For all U.S. university research reactors that can be converted
using existing LEU fuels, NNSA's Global Threat Reduction Program
completed the conversions two years ahead of schedule in September
2009. New LEU fuels are currently being developed to convert the
remaining U.S. research reactors, which are expected to convert to LEU
fuel by 2016.
There are research reactors in the United States that operate on
LEU and HEU fuel that can produce Mo-99. However, the LEU fueled
research reactors operate at much lower power level relative to the
current global producers, and these facilities are not likely to be
able to achieve large-scale commercial production. The HEU-fueled
research reactors do not have the necessary infrastructure or
programmatic mission to readily produce Mo-99 for the domestic
commercial market. The largest global producers nominally operate at
the following power levels: the NRU in Canada operates at 135 MW, the
BR-2 in Belgium operates at 100 MW, the HFR in The Netherlands operates
at 50 MW and the SAFARI-I in South Africa operates at 20 MW. The global
reactors that produce large-scale quantities of Mo-99 operate at much
higher power levels than the LEU-fueled research reactors in the United
States.
Beyond having the power level necessary for producing neutrons for
Mo-99 production, large-scale commercial production also requires a
complex chemistry process to create the product that meets FDA
standards.
NNSA has executed two cooperative agreements with commercial
entities seeking to develop domestic commercial Mo-99 production
capability. NNSA is in the process of establishing two more commercial
partnerships. Each commercial entity is pursuing a different technical
pathway toward commercial isotope production. Two pathways involve the
use of reactors utilizing LEU fuel, and two pathways involve neutron
capture and accelerator technology. Of the pathways that use a reactor
for Mo-99 production, the reactor must operate consistent with U.S. HEU
minimization policy by using LEU fuel, or have committed to convert to
LEU fuel once an appropriate LEU fuel is developed and commercially
available.
Responses of Parrish Staples to Questions From Senator Risch
Question 1. What are the national security and economic benefits to
domestically producing medical isotopes? Is there a concern that U.S.
leadership in medical technologies would be adversely impacted by not
pursuing domestic production?
Answer. One of NNSA's objectives is to minimize the commercial use
of HEU in the global production of medical isotopes as the primary
national security nonproliferation benefit. The additional benefits are
largely economic. In view of the current and projected shortages from
foreign suppliers, there is significant advantage for U.S. companies to
provide Mo-99 to the U.S. market. Producing Mo-99 domestically will
also increase the efficiency of its use, given the short half-life of
the isotope and the time required for transport. Domestic production
will also help ensure a reliable supply of this critical medical
isotope to patients in the United States. NNSA cannot comment on U.S.
leadership in medical technologies.
Question 2. Can you describe the waste streams that result from
accelerator and both LEU and HEU reactor produced isotopes and discuss
the disposal and proliferation concerns present with each particular
method?
Answer. Wastes generated from the accelerator-based Mo-99
production technology under consideration does not pose a proliferation
concern because there is no uranium present in the waste stream.
Wastes generated from the LEU-based Mo-99 production technologies
under consideration do not pose a proliferation concern because HEU
would not be present in the waste stream. There is a disposition
pathway in the U.S. for Class A radioactive waste, but some States do
not have access to disposal facilities for their Class B or C
radioactive waste. The Department of Energy is early in the process of
developing disposal capacity for Greater than Class C radioactive
waste.
Wastes generated from HEU-based Mo-99 production technology
presents a proliferation concern because HEU is present in the waste
stream. According to the National Academies Report Medical Isotope
Production without Highly Enriched Uranium, most process wastes from
global Mo-99 producers are in a liquid or solid form and are either
stored at producers' sites or transported to offsite storage
facilities. Disposition pathways for HEU-based Mo-99 wastes in the
United States have not been identified, in part because future Mo-99
production in the United States would not use HEU.
Responses of Parrish Staples to Questions From Senator Wyden
Question 1. Please provide a copy of the 1996 Record of Decision
for Mo-99 concerning production at the Sandia National Laboratory (SNL)
Annular Core Research Reactor (ACRR).
Answer. The Record of Decision is provided as an insert of the
record.* The information follows.
---------------------------------------------------------------------------
* Document has been retained in committee files.
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Question 2. Provide a detailed description of the capital
investments and support costs incurred by the Department and SNL for
implementing the Mo-99 production ROD.
Answer. Department of Energy's Office of Nuclear Energy (NE)
provided $12.6 million in FY 1998 and $8.5 million in FY 1999 to the
Sandia and Los Alamos national laboratories to accomplish this program.
Additionally, $1.08 million of carryover funding from FY 1997 was
available to support the project, for a total of $22.18 million. On
July 30th, 1999, NE directed that the Medical Isotope Program as
described in the Project Execution Plan be closed out.
Question 3. Please provide a copy of the Department's 1999
Expression of Interest (EOI) for utilization of the SNL Mo-99 capacity
and copies of all responses to EOI.
Answer. While we were unable to locate copies of responses to the
EOI, I would like to provide the EOI and associated instructions as an
insert for the record.** The information follows.
---------------------------------------------------------------------------
** Information has been retained in committee files.
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Question 4. Provide an explanation of the Department's 2007
decision to modify the ACRR core configuration and remove Mo-99
production capacity and all related decision documents.
Answer. In April 1999, DOE's Office of Defense Programs (DP)
recognized an immediate need to conduct a limited-term test campaign on
specific weapon components: the ACRR represented the best facility
available to meet the technical and schedule testing requirements of
this campaign. The ACRR had been transferred to DOE-NE, which was
reconfiguring the ACRR and associated facilities for the production of
various isotopes. However, schedule delays and cost overruns presented
a window of opportunity for DP to conduct its weapon tests without
impacting the overall isotope program schedule. So, NE and DP signed an
agreement governing the reconfiguration of the ACRR from the isotope
production configuration to the pulse-testing configuration and
authorizing its temporary use in FY 2000 for pulse testing-activities.
In July 1999, in conjunction with unsuccessful efforts to privatize
Mo-99 production and after careful consideration, the administration
terminated the Mo-99 project. Specifically, an increase in the world's
production capacity with the pending start-up of new reactors in
Canada, Maple 1 and 2, negated the urgency of establishing an emergency
backup capability in the United States. (The Maple projects were
subsequently terminated on May 19, 2008.) The ACRR and associated Hot
Cell Facility were transferred back from NE to DP in FY 2006 for DP's
mission-related work. No nuclear materials were placed into the hot
cells, and some of the Mo-99 production equipment was transferred to
other national laboratories for use in their production of other
isotopes.
Question 5. Provide a detailed description of the costs associated
with modification of the ACRR core and disposition of fuel elements and
related components.
Answer. As of September 30, 1999, project costs associated with the
modification of the ACRR totaled $21.1 million, with a further $560,000
committed for work during FY 2000 to complete hot cell facility (HCF)
modifications, for a project total of $21.7 million. This total was
$405,000 below the project execution plan budget estimate of $22.1
million. These costs do not include disposition of fuel elements which
are still located at ACRR and associated adjacent facilities.
Question 6. To what extent are the Department's ongoing efforts to
restore domestic production capability of Mo-99 cost shared with the
private sector and identify the levels of funding and sources provided
to date by the private sector, if any?
Answer. Section 988 of the Energy Policy Act of 2005 establishes
guidance for the U.S. Department of Energy's cost-sharing requirements
for demonstration and commercial application activities. This guidance
is a 50 percent cost share for demonstration and commercial application
activities.
NNSA's support to commercial entities under cooperative agreements
requires a 50 percent cost share commitment, with a funding limit for
the NNSA share. Some commercial partners have opted to contribute more
funding to their projects than the 50 percent share. The funding and
sources provided to date by the private sector are proprietary
information, but NNSA has committed $5.627 million to date.
Question 7. The Department of Energy has testified in support of
H.R. 3276 which would authorize $163 million for establishment of a
program ``to evaluate and support projects for the production in the
United States, without the use of highly enriched uranium, of
significant quantities of molybdenum-99 for medical uses.'' The
legislation does not specify any cost share for private sector
participants. Does the Department envision that this program would, in
fact, be cost-shared and if so to what extent?
Answer. NNSA's four projects are intended to be demonstrated with
commercial entities under cooperative agreements that have a 50/50%
cost share requirement. If H.R. 3276 were enacted, the Department
envisions that the program would continue to be implemented based on a
50/50% cost-share arrangement.
Question 8. Does the Department object to inclusion of a
legislative requirement clarifying that the program to evaluate and
support domestic Mo-99 production should be cost-shared?
Answer. No, the Department does not object.
______
Responses of Kevin D. Crowley to Questions From Senator Murkowski
Question 1. Dr. Crowley, the National Academies report suggests
that it is technically feasible that adequate quantities of medical
isotopes can be produced from LEU targets. Could you describe what the
options are, and whether LEU target designs from other countries could
be used here in the United States?
Answer. There are two primary options for producing medical
isotopes using low enriched uranium (LEU). The first option is to
irradiate LEU targets in research and test reactors. These reactors
have high-power-density cores that produce high neutron fluxes--
typically on the order of 100 trillion to 1000 trillion neutrons per
square centimeter per second. The irradiation of LEU targets with
neutrons induces fission of the uranium 235 that is contained in the
target material. Approximately 6 percent of these fissions produce
molybdenum 99. After irradiation, the targets are removed from the
reactor and chemically processed to recover molybdenum. There are
several operating research and test reactors in the United States that
could, in principle, be used to irradiate LEU targets for molybdenum 99
production. However, reactor schedules and operations might have to be
modified and target processing facilities would have to be constructed
to enable commercial-scale production.
The second option is to irradiate LEU in solution reactors. The LEU
is dissolved in an acidic solution that serves as both the reactor fuel
and target; the irradiation of uranium 235 in the solution produces
molybdenum 99 just as in a research and test reactor. The solution is
periodically drawn off and the molybdenum 99 is chemically separated
and recovered. Solution reactor production of molybdenum 99 is a
relatively new concept; to my knowledge it has only been demonstrated
at scale in Russia. There are no operating solution reactors in the
United States.
There are other potential options for producing molybdenum 99.
These include neutron activation of molybdenum 98 in reactors and
accelerator-based production involving uranium 235 fission, uranium 238
photo fission, photon-induced conversion of molybdenum 100, and the
direct production of technetium 99m from molybdenum 100. Our study
concluded that, at present, these options are not capable of producing
sufficient molybdenum 99 to meet a substantial fraction of U.S. demand.
However, one or more of these options might be suitable for meeting
demand in smaller countries.
To date, two LEU target designs have been developed for use in
molybdenum 99 production. Argentina designed and is using an LEU-
aluminum alloy target for commercial production of molybdenum 99; that
target is also being used for commercial production in Australia.
Argonne National Laboratory has led the development of a uranium metal
foil target that has been test irradiated in Argentina, Australia,
Indonesia, and the United States.
Either of these target designs could be used to produce molybdenum
99 in the United States. However, some technical development would be
required to adapt these targets to specific reactors and processing
facilities.
Question 2. Dr. Crowley, your testimony notes that Mo-99 producers
have no good business reason to convert to LEU-based production.
a. Why should we expect these businesses to pony up the
millions of dollars to convert to a process that requires more
uranium for the targets, but doesn't enhance quality or reduce
costs?
b. Who should bear the burden of conversion costs--industry
or government?
Answer. The answers to these questions can be found in Chapter 10
of our medical isotopes report: ``There are currently no financial or
competitive reasons for industry to convert to LEU-based production.
The only reason for conversion is to support HEU minimization goals.
One could argue that private industry should not be expected to
shoulder the entire cost of obtaining this benefit, but that
governments should also bear part of this burden.'' Our report
suggested that the federal government could encourage conversion by
providing technical assistance, temporary financial incentives, and
consistent policy signals. Many of our suggestions have been embodied
in HR 3276.
There is an instructive parallel between conversion of targets for
medical isotope production and conversion of fuel for research and test
reactors. The Reduced Enrichment for Research and Test Reactors (RERTR)
Program was initiated by the Department of Energy (DOE) in 1978 to
develop, test, and qualify LEU fuels for research and test reactors.
DOE offers several incentives to research and test reactor owners/
operators to ease the burden of conversion from HEU to LEU fuels. These
incentives include technical assistance to develop and qualify LEU
fuel, financial assistance to purchase the first LEU replacement core,
and take back of HEU reactor fuel. These incentives appear to be an
effective tool for conversion of research reactors to LEU fuel.
Question 3. The National Academies report concluded that the
potential cost difference for Mo-99 produced from LEU would cost no
more than 10% more than that produced from HEU. The recent shortages in
Mo-99 have seen significant increases in cost for the isotope thereby
making the concerns for cost of switching from HEU to LEU production
moot. However, who is financially benefitting from the increased cost--
the foreign-government owned reactors, or the supplier industry?
Answer. Pricing agreements between molybdenum 99 producers and
reactor owners/operators and between molybdenum 99 producers and
isotope buyers are generally proprietary, so it is not possible to
provide a revenue breakdown; however, I can offer a personal opinion
based on my understanding of the medical isotope production business.
Molybdenum 99 production is subject to the same supply-demand economics
that govern the sale of many other commodities. Producers can charge
more for this isotope when demand exceeds supply, especially over
extended time periods. Isotope buyers who have long-term purchasing
agreements with molybdenum 99 producers may be protected from large
price increases, but this would not be the case for buyers who purchase
molybdenum 99 on the spot market.
The molybdenum 99 supplied to the United States is produced in
multipurpose reactors that are owned and/or operated by foreign
governments. The owners/operators of these reactors have long-term
arrangements with medical isotope producers and others to provide
irradiation services. The costs for these irradiation services are
usually unrelated to molybdenum 99 prices unless the reactor owner/
operator has a revenuesharing agreement with the molybdenum 99
producer.
Consequently, when a molybdenum 99 producer pays a fixed price for
irradiation services and can charge more for the molybdenum 99 it
produces it would realize a financial benefit. However, molybdenum 99
producers sometimes incur additional expenses to maintain a reliable
supply system, so not all of the additional revenue would necessarily
be realized as profit.
Response of Kevin D. Crowley to Question From Senator Cantwell
Question 1. In your written testimony you mentioned a study you
recently directed: Medical Isotope Production without Highly Enriched
Uranium. The American Medical Isotope Production Act, as currently
written, would not provide for a full conversion to LEU-based domestic
production for 7-11 years. In carrying out this study, did you arrive
at new suggestions or guidance regarding the ways the US can use
research reactors that have already converted to LEU fuels and are
capable of producing Mo-99?
Answer. Our report specifically examined the feasibility of
producing molybdenum 99 in the Missouri University Research Reactor.
This reactor is currently fueled with HEU but will be converted to LEU
as soon as a suitable replacement fuel becomes available. (Conversion
is scheduled for fiscal year 2014.) Commercial-scale production of
molybdenum 99 in the Missouri reactor using LEU targets appears to be
technically feasible, but target processing facilities would need to be
constructed.
Our report also examined the feasibility of producing molybdenum 99
in solution reactors that use LEU dissolved in an acid solution as both
the fuel and target material. Babcock & Wilcox has announced a
partnership with Mallinckrodt to construct such a reactor in the United
States. This type of reactor has never been licensed by the U.S.
Nuclear Regulatory Commission, and some licensing uncertainties must be
resolved before a reactor could be constructed in the United States.
The Babcock and Wilcox solution reactor has very low power and is
designed to operate at atmospheric pressure and below the boiling point
of water. Consequently, it appears unlikely that safety issues would be
a significant impediment to licensing.
There are other research reactors in the United States that could
potentially be used for medical isotope production, but these were not
specifically examined in our report. A reactor that is used to produce
molybdenum 99 at commercial scale must meet several requirements: it
must have sufficient space in the reactor core or reflector region to
accommodate LEU targets without interfering with other reactor uses; a
sufficiently high power to provide the necessary neutron fluxes; a
reliable operating schedule to allow 24/7 production, except during
planned maintenance outages; and access to ancillary facilities for
handling and processing irradiated targets. To my knowledge, no
research reactors in the United States currently meet all of these
requirements.
Responses of Kevin D. Crowley to Questions From Senator Risch
Question 1. Please list the current domestic sources of moly-99
isotopes, the nondomestic sources and the percentage of our imports
from each source. Additionally, please list the potential domestic
sources for such isotopes from both reactor and accelerator
technologies.
Answer. At present there are no domestic sources of molybdenum 99
for medical use. Until early 2009, the United States received about 60
percent of the molybdenum 99 used for medical purposes from Canada
(AECL/MDS Nordion) and 40 percent from the Netherlands (Mallinckrodt).
However, production from Canada was halted in May 2009 when a heavy
water leak was discovered in the Canadian NRU Reactor. Since that time,
the United States has received molybdenum 99 primarily from
Mallinckrodt in the Netherlands and NTP Radioisotopes in South Africa.
Additionally, arrangements have been made to supply molybdenum 99 to
the United States from Australia (ANSTO), although it is not clear that
this producer is shipping commercial quantities at present. The
quantities of molybdenum 99 supplied to the United States by these
organizations are considered to be proprietary and are not publicly
available.
I am aware of two U.S.-based organizations that propose to supply
molybdenum 99 to the domestic market: the Missouri University Research
Reactor and Babcock & Wilcox, the latter using a solution reactor. Each
of these organizations could probably produce enough molybdenum 99 to
supply at least a third or more of U.S. needs, assuming that financing
can be arranged to construct the necessary facilities. At this point in
time, accelerator production of molybdenum 99 is unlikely to produce
large supplies unless multiple facilities are constructed. It is not at
all clear whether accelerator production would be cost competitive with
reactor-based production.
Question 2. What is the current US demand, and how much of that
demand could be met through the potential accelerator sites listed
above?
Answer. Under normal supply conditions, the demand for molybdenum
99 in the United States is between 5000 and 7000 6-day curies per week.
Our study did not attempt to estimate how much of that demand could be
met through accelerator production. Multiple accelerators likely would
be required to produce quantities of molybdenum 99 to be competitive
with reactors; the cost of construction and operation of multiple
accelerators would have to be analyzed to determine if a business case
could be made for molybdenum 99 production.
______
Responses of Roy Brown to Questions From Senator Murkowski
Question 1. Does CORAR believe that the bill's language is
technology neutral in supporting an LEU-based domestic production
capacity, or does it favor reactors over accelerators or neutron
capture technology?
Answer. CORAR believes the DOE should remain technology-neutral
during their selection process for dispersal of funds for the
development of domestic medical isotope projects. We believe the bill
as written is technology-neutral to both reactor and accelerator
processes.
Question 2. Waste disposal.--If DOE were not required to take back
the radioactive waste from a future domestic Mo-99 isotope process what
are the industry's options? Has the industry determined what it
believes a reasonable price for DOE to charge for waste disposal would
be?
Answer. In the U.S. currently there are no disposal facilities for
Class B or Class C radioactive waste. For that reason we strongly feel
DOE should make their already available sites for disposal of these
types of waste, and all waste generated as a result of medical isotope
production from the use of DOE leased uranium available. Unless this is
done, the producers of these medical isotopes using DOE leased uranium
will have nowhere to dispose of this waste. The industry does not have
a target price in mind for the disposal of this waste at DOE
facilities. As previously stated by CORAR, we are concerned that the
price DOE may set for this waste disposal, could be unreasonably high,
which would hamper development of U.S. medical isotope production. We
have seen DOE add allocations and other additional charges to fees for
other services we have received from them. We wanted to assure that
these ``up charges'' are not added to the waste disposal fees. We
suggest that the price for this waste disposal be developed in
conjunction with the National Academy of Sciences and/or DOE's Nuclear
Science Advisory Committee on Isotopes. The NAS is sensitive to the
costs associated with production of medical isotopes in the U.S. as a
result of their report on the production of Mo-99 using LEU, and the
NSACI has nuclear medicine experts from the industry that would be
sensitive to waste disposal prices that may inhibit development of U.S.
produced medical isotopes.
Question 3. Environmental studies.--I agree that having both DOE
and NRC conduct separate environmental studies of proposed production
and processing facilities is duplicative, costly, and unnecessarily
delays the process. Am I correct in understanding that CORAR's
preference is for the environmental review to fall with the NRC instead
of DOE?
Answer. Our hope is to avoid unnecessary duplicative regulatory
constraints. We feel the NRC licensing process for any new reactor
facility and any new processing facility will adequately address any
environmental concerns.
Question 4. What is the current level of interest by industry to
provide for domestic production of Mo-99? I understand that Babcock and
Wilcox have a solution reactor design they are working on, and the
University of Missouri is interested in converting their research
reactor to LEU use. What other possibilities are out there?
Answer. In addition to the B &W/Covidien and MURR efforts stated in
your question, we are aware of several other efforts in the U.S. in
various stages of development. They include the following:
UCDavis Use of the McClellan reactor
University of Washington Use of their research reactor
Sandia National Lab Construction of a new Fuel Pin reactor
Iotron Use of an accelerator for the production
of Mo-99
Puerto Rico Construction of a new reactor
Oak Ridge National Lab Use of the HFR at ORNL by a private
consortium
Idaho State University/ Use of an accelerator for the production
Positron of Mo-99
We are also aware of several other efforts underway in the U.S.,
that may not be as far along as these listed. There are also other
efforts underway in Canada and Europe. There are other possibilities
with the ATR at Idaho Falls National Lab, and the ACRR at Sandia
National Lab. There are several impediments which would have to be
overcome before these reactors could be used. Some of these impediments
are physical attributes of the reactor and some are operational.
Responses of Roy Brown to Questions From Senator Wyden
Question 1. Your testimony on behalf of the Council on
Radionuclides and Radiopharmaceuticals (CORAR) supports enactment of
H.R. 3276 to create a program to establish medical isotope production
in the United States. When the U.S. Department of Energy created just
such capacity at the Annular Core Research Reactor (ACRR) at Sandia at
a cost of as much as $50 million, the U.S. radiopharmaceutical industry
chose not to support that capacity. Why should the Federal Government
spend an additional $163 million to develop a domestic supply and what
assurance can the industry provide that it will utilize the resulting
facilities?
Answer. In the 1990's when DOE offered to retrofit the ACRR in
order to produce Mo-99 the industry was an active supporter and
financial contributor to that effort. However, the DOE was unable to
finish that project, and then tried to privatize it. Unfortunately the
financial stipulations placed on that privatization effort made it
unattractive and non-viable financially; Several tens of millions of
dollars would have been required to finish the ACRR effort at that
time. After that failed ACRR effort the industry pursued other options.
Specifically, Mallinckrodt decided to invest in its own Mo-99
processing operation in The Netherlands and Nordion contracted with
AECL to construct the now moth-balled MAPLE reactors.
With the MAPLE reactors no longer supported by the Canadian
Government and not likely to ever become operational and with other
foreign reactors rapidly aging and failing, the industry is strongly
supportive of the $163 million contained in the AMIPA. This will be
instrumental in accelerating a new, domestic Mo-99 production capacity.
We feel strongly that this funding must result in project investments
that are fully vetted, including input from industry. Funding of
projects that lack credibility and only support theoretical research in
isotope production will not help develop a U.S. supply of Moly-99 and
ensuring that US patients have access to important procedures using
medical isotopes.
Question 2. If the Federal Government were to proceed with the
proposed program to develop multiple domestic isotope supply options as
proposed in H.R. 3276, why shouldn't the industry be required to enter
into binding agreements to utilize those facilities?
Answer. There are two generator manufacturers in the U.S. Both of
those manufacturers have expressed strong interest in a U.S.-based Mo-
99 production sources. However, both of these companies are also
pursuing other options to increase worldwide capacity for medical
isotopes to meet short-and medium-term needs of U.S. patients. The cost
of each proposed U.S.-based medical isotope production option must be
examined carefully to assure they will be able to provide isotopes at
reasonable prices. The generator manufacturers are committed to
providing our patients with reliable and cost effective medical
isotopes. If these new U.S. production capabilities yield reliable and
cost effectiveMo-99 , the manufacturers will be willing/ready to enter
into agreements with those groups. Until the necessary factors are
clearly known, entry into binding agreements would be irresponsible,
and would not be in the best interest of our patients or in containing
the cost of healthcare.
The solution to the long term isotope supply problem is rooted in
the maintenance of a global, competitive market for the production and
sale of Mo-99. The proposed domestic production solutions will fill a
gap in the current global Mo-99 supply chain as its legacy assets
continue to age. The domestic solutions that prevail will be well
positioned as the most reliable and cost effective source of supply
given the age and geographic proximity of the competing suppliers.
Market dynamics and the existence of diverse supply options will
mitigate reliability and pricing related risks to the benefit of the
industry and healthcare system. Positioning these new domestic sources
of supply in the competitive marketplace vs. the alternative of
proactive binding supply agreements is the best approach for the
industry and the payers.
Question 3. To what extent is the industry willing to share the
costs of implementing the proposed domestic isotope production program?
Answer. Please note that these two manufacturers are already
incurring significant additional costs to at least partially mitigate
impact on US patients of the ongoing crisis in Moly-99 supply.
Moreover, the two generator manufacturers will have significant costs
qualifying and these new suppliers of medical isotopes and gaining FDA
approval for use of their Mo-99. It costs roughly $1 million to add
each new supplier of isotopes. The complex process includes the need to
produce generators in validation batches with isotopes from the new
supplier. These validation generators need to be tested with the ``cold
kits'' containing drugs that are commonly combined with Tc-99m. These
tests demonstrate that the Tc-99m from the new Mo-99 reacts with the
cold kits as expected and meets all of the FDA specifications for these
kits. Data are collected from several validation batches of generators,
then that data is submitted to the FDA for review as a supplement to
the manufacturers' New Drug Application (NDA) for their Tc-99m
generators. The FDA reviews this data, and if found acceptable, grants
permission for use of the Mo-99 from the new supplier. As previously
stated, this is an expensive and time consuming effort. Each additional
Mo-99 supplier a generator manufacturer wishes to add requires a repeat
of this process. In addition to those validation and approval
investments, the manufacturers may choose to also share in the Mo-99
facility development costs. This depends, in part, on the facility's
perceived chances of becoming a reliable and cost efficient supplier,
as previously discussed. While this funding represents a welcome means
to help projects with a domestic production agenda to become a
commercial reality, it is important to note that significant additional
funding will be required from industry and other private and public
sources. In addition, we encourage DOE decision-makers to consider
funding those projects with the highest probability of success that
will work within the model of the current supply chain. Otherwise, the
more funds disbursed to low probability alternatives will mean less
funding availability for higher probability shorter timeline projects.
Question 4. In aggregate, what is the annual revenue to the
radiopharmaceutical industry in the U.S. from the sale of isotopes,
including Mo-99 and derivatives, currently and projected over the next
five, ten, and fifteen years?
Answer. Such an estimate is very difficult to make for the reasons
outlined below. The best source of information is probably Arlington
Medical Resources Inc. (AMR). Aggregate revenue will be difficult to
estimate because of Mo-99 per curie pricing uncertainty, which itself
is a function, at least in part, of available future supply. Perhaps
doses administered is a metric more easily predicted, but that may also
be a function of available supply and Mo-99 price.
Appendix II
Additional Material Submitted for the Record
----------
U.S. Senate,
State of Missouri,
Washington, DC, December 11, 2009.
Hon. Jeff Bingaman,
Chairman, U.S. Senate Committee on Energy and Natural Resources,
Washington, DC.
Hon. Lisa Murkowski,
Ranking Member, U.S. Senate Committee on Energy and Natural Resources,
Washington, DC.
Dear Chairman Bingaman and Ranking Member Murkowski, The Energy and
Natural Resources Committee recently took testimony on H.R. 3276, the
American Medical Isotopes Production Act of 2009. I support the goals
of H.R. 3276 to promote U.S. domestic production of medical isotopes
and phase out the current process necessary to provide raw materials
for the production of medical isotopes. However, H.R. 3276 fails to
address fundamental issues necessary to ensure that cancer patients
moving forward are guaranteed to receive the medicine they need to
diagnose and treat their illnesses.
Every year, millions of American patients depend upon medicine
derived from medical isotopes to diagnose and treat cancer, heart
disease and other serious ailments. Doctors use medical isotopes to
treat Non-Hodgkin's Lymphoma and thyroid cancer. Patients also depend
upon medical isotopes for bone scans that assess the spread of cancer
up to 18 months earlier than traditional x-ray. Medical isotopes also
allow for the evaluation of kidney function and heart conditions. Thus,
any proposal to block the flow of raw materials currently needed to
produce medical isotopes, as does H.R. 3276, represents a serious
threat to the health and treatment of U.S. patients.
While H.R. 3276 includes a legally binding cut-off date to stop the
flow of raw materials necessary to produce medical isotopes, the bill
provides no guarantee that U.S. patients will continue to receive their
medicine and medical treatment. According to a report by the National
Academies of Science, there ``are not sufficient quantities of medical
isotopes available'' to meet U.S. domestic needs from the new processes
H.R. 3276 envisions to supply medical isotopes. Conversion to a new
medical isotope production process will require tens of millions of
dollars and up to 13 years. Even a short period where patients cannot
get the medicine they need could have grave health consequences.
Let me be clear that I support finding new ways to produce medical
isotopes, especially from domestic sources. However, I am unaware of
any type of comprehensive planning or documentation that describes in
detail exactly who is expected to supply medical isotopes in sufficient
quantities to meet the needs of U.S. medical patients without
disruption, from what locations, how much this will cost to build or
upgrade production facilities, who will provide precise levels of
funding, from which sources, in which years, and with what assurances
to reflect that the funding either exists or is on the way.
I am gratified that all of the parties involved seem to be
operating in good faith with the best intentions of seeing the process
move forward. However, authority to create a program or the
authorization to provide funding is not the same as the administration
requesting sufficient funding as part of their annual budget, the
Appropriations Committee actually appropriating such sums, or the
administration actually spending such sums. Likewise, an administration
agreeing to provide some level of funding is not the same as reaching
agreement on funding and construction plans with private parties in the
number and to the degree necessary to ensure supply of U.S. domestic
needs without disruption or shortfall.
The hearing by the Committee shows that you are engaged in this
issue and willing to ask thoughtful questions of the process. My staff
is fully prepared to engage in any efforts with your staff to improve
H.R. 3276. However, you should know that I will use the options
available to me as a Senator to prevent consideration of this bill on
the floor before these issues are resolved. Thank you in advance for
your attention to this matter.
Sincerely,
Christopher S. Bond,
U.S. Senator.
______
Economic Development Corporation of Lea County,
Hobbs, NM, December 1, 2009.
Hon. Chairman Bingaman,
Hon. Ranking Member Murkowski,
Senate Energy and Natural Resources Committee, Senate Dirksen Room 304,
Washington, DC.
Dear Chairman Bingaman and Ranking Member Murkowski: We are writing
you today to express our support for H.R. 3276 the American Medical
Isotopes Production Act of 2009. We believe that there is a very real
need in this country for reestablishing the domestic production of
medical isotopes and we feel that Lea County is well positioned to be a
part of the answer to that need.
Given our history as a resource for the nation's energy needs, Lea
County is well positioned to host a complete production facility that
includes a dedicated, purpose-built reactor and separations and
generator production complex. Our proximity to the National Enrichment
Facility and Waste Control Specialists, experience in obtaining
permitting and licensure for a NRC regulated facility, and
understanding and support of the local community and region for nuclear
projects creates an excellent opportunity to build a long-term
successful solution for medical isotope production. As a strategy for
the production of molybdenum-99 is being solidified, we would encourage
decision makers to consider a long-term, full spectrum, dedicated,
community initiated project to be a viable solution for the US.
Further, we believe that domestic medical isotope production can be
achieved without the use of highly enriched uranium with its attendant
proliferation and security concerns.
In order to provide the most robust array of solutions for this
critical need we believe the current legislation should be amended to
allow for the use of a dedicated and single purpose production system
instead of only a short-term potentially makeshift solution. While
expediency is a factor to consider, equal or greater weight should be
given to the overall strategic quality of the proposed molybdenum-99
production system. Dedicated and purpose-built production systems will
ensure the long-term strategic needs of the US are met, rather than
relying on stop-gap measures. We also believe that the current
legislation does not give merit or consideration to the waste
management practice for a proposed production system. While the waste
burden is not particularly great with most molybdenum-99 production
systems, given the general challenges of radioactive waste management
facing our country, we feel it would be prudent if the legislative
criteria included a factor that considered waste type and volume, waste
disposal pathway, and waste management practices. Finally we would like
to see the legislation include criteria that considers the degree of
local stakeholder community support.
In August 2009, the Society of Nuclear Medicine polled its members
and 80 percent reported their medical practice or facility had been
negatively impacted by the medical isotope shortage. Lea County would
like to help meet this critical need. Included with this letter is some
draft amendment language we hope you will consider as this legislation
moves forward.
Thank you,
Johnny Cope,
Energy Committee, Chairman.
draft language
SEC. 3. IMPROVING THE RELIABILITY OF DOMESTIC MEDICAL ISOTOPE
SUPPLY
(a) Medical Isotope Development Projects--
(1) IN GENERAL--The Secretary of Energy shall establish a
program to evaluate and support projects for the production in
the United States, without the use of highly enriched uranium,
of significant quantities of molybdenum-99 for medical uses.
(2) CRITERIA--Projects shall be judged on their overall
strategic qualities to meet U.S. needs and interests, and
against the following primary criteria:
(A) The length of time necessary for the proposed
project to begin production ofmolybdenum-99 for medical
uses within the United States.
(B) The capability of the proposed project to produce
a significant percentage of United States demand for
molybdenum-99 for medical uses.
(C) The cost of the proposed project.
(D) The likelihood for securing regulatory approval
and licensing of the proposed project.
(E) The strategic quality of the proposed project to
meet long-term capacity and reserve needs, including
the degree to which the proposed project is dedicated
and purpose built for molybdenum-99 production,
(F) The overall waste management plan and fate of the
waste burden for the proposed project.
(G) The degree of local community support for the
proposed project.
______
SNM,
Reston, VA, November 24, 2009.
Hon. Jeff Bingaman,
Chairman, Senate Committee on Energy and Natural Resources, U.S.
Senate, 703 Hart Senate Office Building, Washington, DC.
Hon. Lisa Murkowski,
Ranking Member, Senate Committee on Energy and Natural Resources, U.S.
Senate, 709 Hart Senate Office Building, Washington, DC.
Dear Chairman Bingaman and Ranking Member Murkowski: The Society of
Nuclear Medicine\1\ (SNM)--an international scientific and medical
organization dedicated to raising public awareness about what molecular
imaging is and how it can help provide patients with the best health
care possible--appreciates the Committee on Energy and Natural
Resources' consideration of the American Medical Isotopes Production
Act of 2009 (HR. 3276). The American Medical Isotopes Production Act
would help to ensure a domestic supply of the important isotope
Molybdenum-99 (Mo-99) within the US and to curtail the use of highly-
enriched uranium (HEU) in radionuclide production as a non-
proliferation strategy to deter terrorism. As you know, Mo-99 decays
into Technetium-99m (Tc-99m), which is used in approximately 16 million
nuclear medicine procedures each year in the US. Recent disruptions in
the supply of Mo-99 have highlighted the urgent need to ensure a
domestic supply for the US. The American Medical Isotope Production Act
will help patients who rely on medical imaging for the treatment and
diagnosis of many common cancers by authorizing funding and providing a
clear road map to create a domestic supply of Mo-99 while also allowing
a responsible timeline and safeguards for the transfer of HEU to low
enriched uranium (LEU); therefore, SNM endorses the American Medical
Isotope Production Act of 2009.
---------------------------------------------------------------------------
\1\ SNM is an international scientific and medical organization
dedicated to raising public awareness about what molecular imaging is
and how it can help provide patients with the best health care
possible. SNM members specialize in molecular imaging, a vital element
of today's medical practice that adds an additional dimension to
diagnosis, changing the way common and devastating diseases are
understood and treated. SNM's more than 17,000 members set the standard
for molecular imaging and nuclear medicine practice by creating
guidelines, sharing information through journals and meetings and
leading advocacy on key issues that affect molecular imaging and
therapy research and practice. For more information, visit www.snm.org.
---------------------------------------------------------------------------
Tc-99m is used 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. In addition to pinpointing
the underlying cause of disease, physicians can actually see how a
disease is affecting other functions in the body. Imaging with Tc-99m
is an important part of patient care. As you may be aware, SNM, along
with thousands of nuclear medicine physicians in the US, have, over the
course of the last two years, been disturbed about supply interruptions
of Mo-99 from foreign vendors and the lack of a reliable supplier of
Mo-99 in the US. Due to these recent shutdowns in Canada, numerous
nuclear medicine professionals across the country have delayed or had
to cancel imaging procedures. Because Mo-99 is produced through the
fission of uranium and has a half-life of 66 hours, it cannot be
produced and stored for long periods of time. Unlike traditional
pharmaceuticals, which are dispensed by pharmacists or sold over-the-
counter, nuclear reactors produce radioactive isotopes that are
processed and provided to hospitals and other nuclear medicine
facilities based on demand. Any disruption to the supply chain can
wreak havoc on patient access to important medical imaging procedures.
In order to ensure that patient needs are not compromised, a
continuous reliable supply of medical radioisotopes is essential.
Currently there are no facilities in the US that are dedicated to
manufacturing Mo99 for Mo-99/Tc-99m generators. The United States must
develop domestic capabilities to produce Mo-99, and not rely solely on
foreign suppliers. In addition, forcing a change from HEU to LEU must
be done with adequate time made available for the research and
development needed for the transition period. There also must be
consideration of economic and environmental factors to prevent, first
and foremost, putting patients at risk because of delays in production
of much needed radionuclides, such as Technetium-99m (Tc-99m) which is
made from Mo-99. With one of the major facilities in The Netherlands
scheduled for a maintenance shutdown while the Canadian facilities are
still not functional will produce an even more acute shortage in the
first half of 2010 making this need for this legislation and funding to
address the shortage more urgent.
This legislation will help address the needs of patients by
promoting the production of Mo-99 in the United States. We thank you
for your efforts and look forward to continuing to work with you on
this important issue.
Sincerely,
Michael Graham, Ph.D., M.D.,
President.
______
American Association of Physicists in Medicine,
College Park, MD, December 2, 2009.
Hon. Jeff Bingaman,
Chair.
Hon. Lisa Murkowski,
Ranking Member, Energy and Natural Resources Committee, 304 Dirksen
Senate Office Building, U.S. Senate, Washington, DC.
Dear Senators Bingaman and Murkowski: The American Association of
Physicists in Medicine (AAPM)\1\--an association whose mission is to
advance the application of physics in medicine and biology for the
benefit of all patients--urges the Senate Energy and Natural Resources
Committee to give full support to and take timely action on H.R.3276,
the American Medical Isotope Production Act of 2009.
---------------------------------------------------------------------------
\1\ The American Association of Physicists in Medicine's (AAPM)
mission is to advance the practice of physics in medicine and biology
by encouraging innovative research and development, disseminating
scientific and technical information, fostering the education and
professional development of medical physicists, and promoting the
highest quality medical services for patients. Medical physicists
contribute to the effectiveness of radiological imaging procedures by
assuring radiation safety and helping to develop improved imaging
techniques (e.g., mammography CT, MR, ultrasound). They contribute to
development of therapeutic techniques (e.g., prostate implants,
stereotactic radiosurgery), collaborate with radiation oncologists to
design treatment plans, and monitor equipment and procedures to insure
that cancer patients receive the prescribed dose of radiation to the
correct location. Medical physicists are responsible for ensuring that
imaging and treatment facilities meet the rules and regulations of the
U.S. Nuclear Regulatory Commission (NRC) and various State regulatory
agencies. AAPM represents over 7,000 medical physicists.
---------------------------------------------------------------------------
AAPM remains concerned that the recent disruptions in the supply of
Molybdenum-99 (Mo-99) have resulted in medical professionals across the
country delaying or canceling imaging procedures. Although there may be
alternatives to certain diagnostic procedures using Technetium-99m (Tc-
99m) (including substitution of other isotopes for Tc-99m, and some
computed tomography (CT) and invasive angiography procedures),
clinicians routinely choose the most accurate, most useful and most
dose-efficient imaging technique. These disruptions in access to the
radioactive isotope have highlighted the urgent need to ensure a
domestic supply for the United States. It is a disservice to patients
to deny them access to the most appropriate study due solely to the
non-availability of Tc-99m in the United States.
In order to ensure that patient needs are not compromised, a
continuous reliable supply of medical radioisotopes is essential.
Currently there are no facilities in the United States that are
dedicated to manufacturing Mo-99 for Mo-99/Tc-99m generators. The
United States must develop domestic capabilities to produce Mo-99, and
not rely solely on foreign suppliers. In addition, forcing a change
from HEU to LEU must be done within an adequate time period to allow
for the research and development needed for the transition period.
There also must be consideration of economic and environmental factors
to, first and foremost, prevent putting patients at risk because of
delays in production of much needed radionuclides, such as Tc-99m which
is made from Mo-99.
A national effort to address these concerns requires (1) a
commitment by the administration to have a coordinated inter-agency
program with the specific responsibility to achieve reliable domestic
independence in the production of Mo-99, (2) continued appropriations
by Congress to provide the financial investment needed by the
administration's program, and (3) support of the Congress through
authorizing legislation that will serve as the basis for the
continuation of the administration's program until its goals are
achieved.
The Obama administration has made a commitment to achieve domestic
independence in the production of Mo-99. The AAPM believes the
initiative being led by the National Nuclear Security Administration
through the Global Threat Reduction Initiative with oversight and
interagency coordination by the Office of Science and Technology Policy
has the capability to achieve the establishment of a reliable domestic
production of Mo-99 within the next ten years. The Congress has
appropriated sufficient support for fiscal year 2010. The remaining
task is to obtain congressional support through authorizing legislation
that will serve as the support and basis for the administration's
program into the future.
AAPM believes that the American Medical Isotope Production Act of
2009 will help patients who rely on medical imaging for the treatment
and diagnosis of many common cancers by authorizing funding and
providing a clear road map to create a domestic supply of Mo-99 while
also allowing a responsible timeline and safeguards for the transfer of
HEU to low enriched uranium (LEU); therefore, AAPM endorses the
American Medical Isotope Production Act of 2009.
We thank you for your efforts and look forward to continuing to
work with you on this important issue.
Sincerely,
Maryellen L. Giger, Ph.D., FAAPM, FAIMBE.
______
Council on Radionuclides and Radiopharmaceuticals, Inc.,
Moraga, CA, January 18, 2010.
Dear Chairman Bingaman and Senator Murkowski, CORAR\1\ strongly
supports H.R. 3276, the American Medical Isotopes Act of 2009, and we
are eager to work with you going forward in the passage of this bill.
Accordingly, CORAR provides our thoughts on the issues raised by
Senator Bond in his letter to you dated December 11.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
Senator Bond raised an important question on appropriations
legislation in support of the bill. H.R. 3276 makes the case for the
authorization of $163 million for the development of domestic medical
isotope production but appropriations legislation is necessary. We
recognize that H.R. 3276 has two goals: The elimination of HEU use in
the production of medical isotopes and, equally important, creation of
a reliable domestic supply of medical isotopes. We stand ready to work
with you on securing the necessary appropriations. Meanwhile, we note
that the Department of Energy spent several million last year targeted
at securing a domestic supply of medical isotopes. In addition, the DOE
has demonstrated its and the Administration's good faith by allocating
already budgeted funds for use in its Cooperative Agreement program,
also targeting the same goals. CORAR is hopeful that these positive
signs will bode well for the necessary appropriations legislation.
Senator Bond also expressed his concern that: ``H.R. 3276 fails to
address fundamental issues necessary to ensure that cancer patients
moving forward are guaranteed to receive the medicine they need to
diagnose and treat their illnesses.'' CORAR shares his goal to provide
patients a reliable and robust supply of medical isotopes for detection
of heart disease or the early detection, staging and treatment of
cancer, all of which can reduce health care costs and improve patients'
quality of life. We believe this legislation will go far in
establishing domestic production of Mo-99 and other critical medical
isotopes. This U.S. production will also increase worldwide capacity of
these isotopes, providing the desired redundancy of a continuous
isotope supply when one or more reactors go down for maintenance. There
are several efforts already underway that look very promising. These
efforts have benefitted from DOE involvement and guidance.
Senator Bond wrote: ``Even a short period where patients cannot get
the medicine they need could have consequences.'' He raised this in the
context of the cut-off date for the export of highly-enriched uranium
(HEU). CORAR shares that concern, but believes the mandatory deadline
included in HR 3276 is critical to ensure that proposed medical isotope
projects will be aggressively pursued and funded. As a result, CORAR
does not support modifying the deadline contained in HR 3276. However,
CORAR encourages the committee to maintain ongoing oversight of medical
isotope supply to ensure that patients' medical isotope needs are not
restricted in 2020.
Senator Bond noted apprehension about the lack of ``any type of
comprehensive planning or documentation that describes in detail
exactly who is expected to supply medical isotopes in sufficient
quantities to meet the needs of the U.S. patients without disruption. .
.'' CORAR remains technology-neutral as to new supplies of medical
isotopes, but is aware of several potentially viable initiatives that
are in progress. The lack of specificity in HR 3276 should be addressed
by the DOE Merit Review Process, assembled to evaluate proposals for
funding of new medical isotope production, with four distinct methods
identified for the production of Mo-99 and other medical isotopes.
These four areas are 1) the production of Mo-99 using conventional
reactor technology with the fission of low enriched uranium (LEU)
targets; 2) the production of Mo-99 utilizing solution reactors using
LEU fuel; 3) the production of Mo-99 using a (y,n)\2\ reaction on Mo-
100; and 4) the production of Tc-99m using a (p,2n)\3\ reaction on Mo-
100.
---------------------------------------------------------------------------
\2\ The (y,n) process or \100\Mo(y,n)\99\Mo is the process by which
you produce Mo-99 by the bombardment of an enriched Mo-100 target with
gamma rays in a high energy accelerator.
\3\ The (p,2n) process or 100Mo(p,2n)99mTc is the process of
producing Tc-99m directly by bombarding Mo-100 targets with protons in
a low energy accelerator. In this process no Tc-99m generator is
necessary since you are directly producing Tc-99m and bypassing Mo-99.
Since Tc-99m has a six hour half-life, this method is only good for
``local'' production of Tc-99m.
---------------------------------------------------------------------------
There are several credible projects in place for the domestic
production of Mo-99 including:
1. The use of the Missouri University Research Reactor (MURR)
for the (n,f)\4\ production of Mo-99.
---------------------------------------------------------------------------
\4\ The (n,f) process or \98\Mo(n,f)\99\Mo is the process of by
which you fission U-235 in a reactor using neutrons. This is the
process all the major producers usually use (i.e. HFR in Petten and NRU
in Canada). There has also been some work done examining the fission of
U-238 in a high energy accelerator.
---------------------------------------------------------------------------
2. The construction of Aqueous Homogeneous Solution Reactors
by Babcock & Wilcox and Covidien for the (n,f) production of
Mo-99 using LEU fuel.
There are also several other efforts being investigated using
existing reactors, building new reactors or using accelerator
technology. These include:
1. The use of the McClellan research reactor by the
University of California-Davis for the LEU (n,f) production of
Mo-99.
2. Construction of a new fuel pin type reactor proposed by
Sandia National Laboratory using LEU fuel as targets, at a site
to be determined.
3. Use of the existing research reactor at the University of
Washington for the production of (n,f) Mo-99.
4. Use of the high flux reactor (HFR) at Oak Ridge National
Laboratory for (n,f) production of Mo-99 by a private
consortium.
5. Construction of a new reactor in Puerto Rico by a private
firm.
6. The use of Electron Beam Accelerator technology by Iotron
for the production of Mo-99 with a (y,n) reaction on Mo-100.
7. Production of Mo-99 by the use of the accelerator at Idaho
State University using a (y,n) reaction on Mo-100.
8. Production of Tc-99m by the use of accelerators using a
(p,2n) reaction on Mo-100 by Positron Corporation.
CORAR believes one or more of these efforts will be commercially
successful and capable of producing a significant portion of the U.S.
needs for Mo-99 and other medical isotopes, such as I-131. Further, it
should minimize the global impact arising from future shutdowns of any
of the major medical isotope producing facilities for maintenance,
helping to prevent a repeat of the current shortage situation due to
insufficient capacity worldwide.
Thank you for the opportunity to provide this information to the
Committee concerning Senator Bond's letter. Please let us know if you
have any questions.
Sincerely,
Roy W. Brown,
Senior Director, Federal Affairs.
______
Statement of S. Andrew Orrell, Director of Nuclear Energy Programs,
Sandia National Laboratories, Albuquerque, NM
With regard to H.R. 3276--American Medical Isotopes Production Act
of 2009, we offer the following comments and suggestions:
1. Sandia National Laboratories (SNL) was tasked by the U.S.
Department of Energy (DOE) in the 1990's to design a
molybdenum-99 production system. SNL has a wealth of experience
gained from its DOE sponsored molybdenum-99 medical isotope
program in the 1990's. This unique experience includes reactor
design and modifications for molybdenum-99 target irradiation,
as well as separation process and facility design. These
efforts were later terminated when Canada committed to the
production of molybdenum-99. Regardless, the expertise still
exists within SNL.
2. We support the intent of HR 3276 to promote the production
of molybdenum-99 in the United States for medical isotope
production, and to do so without the use of highly enriched
uranium and its attendant proliferation and security concerns.
We concur with the National Academy's report confirming that
the production of molybdenum-99 without the use HEU is
technically and economically feasible and that adequate
quantities of medical isotopes can be produced without the use
of HEU. However, we suggest that LEU fission target technology
represents the best technology to meet the strategic needs of
the U.S.
3. The Secretary of Energy criteria for evaluating and
supporting projects, as written in Section 3(a)(2), tend to
favor short-term and perhaps makeshift solutions using modified
capabilities pressed into service, rather than long-term
strategic solutions based on new-build production systems which
are dedicated and purpose-built for meeting the U.S. and export
demand for molybdenum-99. Though expediency is a factor to
consider, greater weight should be given to the overall
strategic quality of the proposed molybdenum-99 production
system. Dedicated, purpose-built production systems will ensure
the long-term strategic needs of the U.S. are met, rather than
relying on stop-gap measures. Given the fragility of the
molybdenum-99 production and supply chain, it is more important
that we get the U.S. policy, for supply and LEU conversion,
right rather rushed.
4. The Secretary of Energy criteria for evaluating and
supporting projects, as written in Section 3(a)(2), does not
give merit or consideration to the waste management practice
for a proposed production system. While the waste burden is not
particularly great with most molybdenum-99 production systems,
given the general challenges of radioactive waste management
facing the USG, it would be prudent if the Secretary's criteria
included a factor that considered waste type and volume, the
availability of waste disposal pathways, and waste management
practices, as a consideration for providing assistance to a
particular project.
5. A new molybdenum-99 production system capability will
likely require local community support for new or adapted
reactor and separations operations. Regulatory approvals for
reactor operations in densely populated metropolitan areas can
be controversial. Community support for any nuclear operation
can at times prove to be difficult to secure, and could lead to
substantial delays affecting the start of production. How long
it will take to get domestic production facilities licensed,
constructed and operating, given the potential for delay due to
environmental or siting concerns, or NRC licensing hurdles for
novel technologies, are significant factors to consider.
Several potential delays are mitigated with strong local
community support. Thus, it is suggested that the Secretary's
criteria should include a factor that considers the degree of
local stakeholder community support.
6. Recognizing the legislation empowers the Secretary of
Energy to provide financial assistance in the development of
fuels, targets and processes for domestic production of
molybdenum-99, we concur with the notion that funding should be
directed to those projects which stand the best chance of
producing commercially meaningful quantities of medical
isotopes, rather than striving for technical neutrality. While
other technologies are conceivable, only LEU fission target
technology has the potential to efficiently balance the demands
for license feasibility and production capacity at predictable
costs and timeframes.
7. Given the issues noted in items 3, 4, 5 and 6 above, we
recommend the language in the Senate version of the American
Medical Isotopes Production Act of 2009 be modified to include
Secretary criteria designed to give merit to projects that
represent an overall strategic quality solution to US needs,
and that:
a. are designed as dedicated and purpose-built production
systems for meeting the full capacity (with reserve) of U.S.
demand,
b. have addressed the management and fate of the waste
burden, and,
c. have demonstrated community support for hosting such
facilities.
Suggested draft language for Section 3 is provided below.
If the Senate Energy and Natural Resources Committee needs any
additional information or technical expertise regarding medical
isotopes and their production, SNL stands ready to assist the Committee
in any way possible. Thank you for providing SNL with an opportunity to
express its views regarding H.R. 3276 and we greatly appreciate your
consideration of our recommendations.
Sandia National Laboratories is a multiprogram laboratory operated
by Sandia Corporation, an autonomous Lockheed Martin company, for the
U.S. Department of Energy's National Nuclear Security Administration.
With main facilities in Albuquerque, N.M., and Livermore, Calif.,
Sandia has major R&D responsibilities in national security, energy and
environmental technologies, and economic competitiveness.
As written:
SEC. 3. IMPROVING THE RELIABILITY OF DOMESTIC MEDICAL ISOTOPE
SUPPLY.
(a) Medical Isotope Development Projects--
(1) IN GENERAL--The Secretary of Energy shall establish a
program to evaluate and support projects for the production in
the United States, without the use of highly enriched uranium,
of significant quantities of molybdenum-99 for medical uses.
(2) CRITERIA--Projects shall be judged against the following
primary criteria:
(A) The length of time necessary for the proposed
project to begin production of molybdenum-99 for
medical uses within the United States.
(B) The capability of the proposed project to produce
a significant percentage of United States demand for
molybdenum-99 for medical uses.
(C) The cost of the proposed project.
Proposed:
SEC. 3. IMPROVING THE RELIABILITY OF DOMESTIC MEDICAL ISOTOPE
SUPPLY.
(a) Medical Isotope Development Projects--
(1) IN GENERAL--The Secretary of Energy shall establish a
program to evaluate and support projects for the production in
the United States, without the use of highly enriched uranium,
of significant quantities of molybdenum-99 for medical uses.
(2) CRITERIA--Projects shall be judged on their overall
strategic qualities to meet U.S. needs and interests, and
against the following primary criteria:
(A) The length of time necessary for the proposed
project to begin production of molybdenum-99 for
medical uses within the United States.
(B) The capability of the proposed project to produce
a significant percentage of United States demand for
molybdenum-99 for medical uses.
(C) The cost of the proposed project.
(D) The likelihood for securing regulatory approval
and licensing of the proposed project.
(E) The strategic quality of the proposed project to
meet long-term capacity and reserve needs, including
the degree to which the proposed project is dedicated
and purpose built for molybdenum-99 production,
(F) The overall waste management plan and fate of the
waste burden for the proposed project.
(G) The degree of local community support for the
proposed project.
______
Astellas US LLC,
Deerfield, IL, November 30, 2009.
Hon. Jeff Bingaman,
U.S. Senate, 703 Senate Hart Office Building, Washington, DC.
Hon. Lisa Murkowski,
U.S. Senate, 709 Senate Hart Office Building, Washington, DC.
Re: American Medical Isotope Production Act of 2009
Dear Chairman Bingaman and Ranking Member Murkowski: On behalf of
Astellas Pharma US, Inc. (Astellas), I am writing in strong support of
the American Medical Isotope Production Act of 2009 recently passed by
the House of Representatives. Astellas believes that this legislation
is critical to ensuring a sufficient supply of radioisotopes used in
life-saving medical tests and procedures. We appreciate the Senate
Energy Committee's consideration of this legislation and look forward
to the Committee's December 3rd hearing to examine this important
issue.
Astellas is among the top 20 global research-based pharmaceutical
companies, and is a recognized leader in the area of pharmacologic
stress agents for nuclear imaging. In North America, our headquarters
are located in Deerfield, IL; our research and development facilities
are located in Santa Monica, CA, Skokie, IL, and Durham, NC; and we
have a production and distribution facility in Norman, OK.
Two Astellas products, Lexiscan and Adenoscan, are cardiac stress
agents used with Technetium-99m (Tc-99m) in radionuclide myocardial
perfusion imaging (MPI). MPI is a key noninvasive test used to assess
blood flow in the heart and to diagnose and manage patients at risk for
a heart attack. The inability of doctors to perform MPI due to a lack
of Tc-99m would result in greater numbers of invasive procedures, and
put patients at risk while increasing the costs of care dramatically.
You have recognized the significant problems with current foreign
sources of radioisotopes, and the real threat that necessary medical
procedures could be unavailable to American patients--with dire
consequences. Your leadership on this issue and this legislation will
ensure that the United States controls its own destiny with
radioisotope production, and that future crises in patient access to
necessary medical care are averted.
We also support the legislation's phase-out of highly enriched
uranium exports, given the safeguards in the legislation for its
temporary continued use during a period of insufficient supply of
molybdenum-99. This time period for transition from highly-enriched
uranium to low enriched uranium will ensure that patient access to
medical radioisotopes remains uninterrupted in the future.
Again, we thank you for your leadership on this effort of vital
importance to patients and providers. We are committed to working with
you and others in ensuring the availability of a stable supply of
radioisotopes for patients.
Sincerely,
Michael J. Ruggiero,
Senior Director, Govt. Policy and External Affairs.
______
Health Physics Society,
McLean, VA, November 30, 2009.
Hon. Jeff Bingaman,
Chair.
Hon. Lisa Murkowski,
Ranking Member, Energy and Natural Resources Committee, 304 Dirksen
Senate Office Building, U.S. Senate, Washington, DC.
Dear Senators Bingaman and Murkowski: On behalf of the Health
Physics Society (HPS), I urge the Senate Energy and Natural Resources
Committee to give full support to and take timely action on H.R.3276,
the ``American Medical Isotope Production Act of 2009.''
The Health Physics Society, a nonprofit scientific organization of
approximately 5000 radiation safety professionals, has joined with
eight other professional organizations in a coalition to address two
concerns of national importance: (1) an inherent need for reliable
domestic suppliers of Molybdenum-99 (Mo-99); and, (2) efforts to
curtail the use of high-enriched uranium (HEU) in radionuclide
production as a non-proliferation strategy and to deter terrorism. A
discussion of these concerns with recommendations for action by the
United States is contained in a white paper by the coalition of
professional organizations titled ``Reliable Domestic & Global Supplier
of Molybdenum-99 (Mo-99) and Switch from Highly Enriched Uranium (HEU)
to Low-Enriched Uranium (LEU) to Produce Mo-99.'' The white paper is
accessible at http://hps.org/documents/isotopes_white-
paper_multiorganization.pdf.
A national effort to address these concerns requires (1) a
commitment by the administration to have a coordinated inter-agency
program with the specific responsibility to achieve reliable domestic
independence in the production of Mo-99, (2) continued appropriations
by Congress to provide the financial investment needed by the
administration's program, and (3) support of the Congress through
authorizing legislation that will serve as the basis for the
continuation of the administration's program until its goals are
achieved.
The Obama administration has made a commitment to achieve domestic
independence in the production of Mo-99. The HPS believes the
initiative being led by the National Nuclear Security Administration
through the Global Threat Reduction Initiative with oversight and
interagency coordination by the Office of Science and Technology Policy
has the capability to achieve the establishment of a reliable domestic
production of Mo-99 within the next ten years. The Congress has
appropriated sufficient support for fiscal year 2010. The remaining
task is to obtain congressional support through authorizing legislation
that will serve as the support and basis for the administration's
program into the future.
The HPS believes H.R.3276 provides the needed congressional support
for the administration's program.
We understand there may be some concern about the provisions in
H.R.3276 for imposing a ban on export of HEU at a fixed time in the
future. HPS's interest in the issue of domestic production of
radioisotopes is related to the radiation safety implications of the
issue, including the implications of exporting HEU for this purpose. In
2005, the HPS did not support the inclusion of an HEU export ban
provision in the Energy Policy Act of 2005. The HPS felt that the
controls under which HEU was exported were rigorous enough to make the
export acceptably safe when compared to the prospect of not having a
supply of Mo-99. This position was influenced by the lack of any
administration program or congressional support for a program dedicated
to the domestic production of radioisotopes. The HPS still considers
the controls for export of HEU for production of radioisotopes to be
rigorous enough to make the risk of diversion for terrorism, or other
malicious use of the HEU to be speculative. However, we feel that with
appropriate congressional support, the initiative to establish reliable
domestic production of Mo-99 will be successful within the next ten
years, making the need to export HEU unnecessary. Therefore, we feel
the export ban provisions will prove to be extraneous and, therefore,
do not form a basis for not supporting H.R.3276.
I hope this letter is helpful in your considered deliberation of
action on H.R.3276. Please do not hesitate to contact me if you have
any questions about this letter or HPS support for H.R.3276.
Sincerely,
Howard W. Dickson, CHP,
President.
______
December 3, 2009.
Hon. Jeff Bingaman,
Chair.
Hon. Lisa Murkowski,
Ranking Minority Member, Energy and Natural Resources Committee, U.S.
Senate, Washington, DC.
Dear Senators, We are writing to express our strong support for
H.R. 3276, the ``American Medical Isotopes Production Act of 2009,''
which was passed in the House of Representatives in November of this
year by an overwhelming 400-17 vote, and to urge the Senate to approve
a counterpart bill as soon as possible. We believe that the bill
strikes the right balance between the acute need to develop a highly
reliable, domestic supply of molybdenum-99, and the crucial policy
objective of working to eliminate the use of nuclear bomb-usable highly
enriched uranium (HEU) in the production process as soon as feasible.
As the text of H.R. 3276 indicates, U.S. patients are already
experiencing supply interruptions of molybdenum-99 as a result of their
reliance on aging, foreign production facilities that have been subject
to prolonged, safety-related shutdowns. While the United States is
contemplating emergency measures to deal with the isotope crisis in the
shortterm, it is equally important to ensure that a credible strategy
is in place to avoid recurrence of the problem in the long-term. We are
confident that the bill will effectively support such a strategy, and
acknowledge the endorsement of H.R. 3276 by major U.S. nuclear medicine
professional associations. We also appreciate that H.R. 3276
responsibly promotes efforts to eliminate the use of HEU in medical
isotope production--including eventually ending the current U.S.
practice of exporting HEU for this purpose--while providing safeguards
to ensure that such efforts will never interfere with the availability
of an affordable supply of these isotopes for U.S. patients.
We commend you and the entire Committee for receiving testimony
today on this important legislation, which not only will have positive
benefits for millions of U.S. patients, but also will help to reduce
the threat of nuclear terrorism that imperils us all.
Sincerely,
Edwin S. Lyman,
Senior Staff Scientist, Global Security Program,
Union of Concerned Scientists.
Frank von Hippel,
Professor of Public and International Affairs, Princeton
University,
Co-chair, International Panel on Fissile Materials.
Henry Sokolski,
Executive Director,
Nonproliferation Policy Education Center.
Sharon Squassoni,
Senior Associate, Nonproliferation Program,
Carnegie Endowment for International Peace.
Alan J. Kuperman,
Associate Professor, and Director of Nuclear Proliferation
Prevention Program,
University of Texas at Austin.
Michele Boyd,
Director, Safe Energy Program,
Physicians for Social Responsibility.
______
Statement of Lloyd Scott, Chief Executive Officer and Chairman, Iotron
Industries Canada Inc., Port Coquitlam, BC
Chairman Bingaman, Ranking Member Senator Murkowski, and members of
the Committee, thank you for the opportunity to submit for the record
the testimony of Iotron Industries Canada Inc. (Iotron). Iotron
strongly supports enactment of H.R. 3276 and commends the House of
Representatives for passing the bill by an overwhelming bipartisan
vote. Iotron also greatly appreciates this Committee's prompt attention
to the critical shortage of the medical isotope Molybdenum 99 (Moly-
99), and related nuclear non-proliferation issues.
Iotron believes that our proven, commercial Electron Beam
accelerator technology can be used to produce Moly-99 in an economic
and timely manner. We are eager to be part of the solution to the
ongoing Moly-99 supply crisis. Iotron strongly supports clarifications
that H.R. 3276 does not favor any particular technology to receive
funding as a Medical Isotope Development Project. Instead, the
Department of Energy (DOE) should be required to make funding decisions
in a technology neutral manner, supporting isotope projects that best
meet the criteria in the bill, regardless of the technology used.
Iotron is not seeking favorable treatment, only fair competition.
iotron background
Iotron is a private corporation headquartered in Vancouver, British
Columbia. Iotron provides advanced irradiation services to industry
using its IMPELA Electron Beam accelerator technology acquired from
Atomic Energy of Canada Limited (AECL) in 2001. These services include
the sterilization of medical devices and molecular modification to
various products, including gemstones and semiconductor materials.
Iotron is a mature company, incorporated in 1989.
If Iotron has the opportunity to compete for the financial support
authorized by H.R. 3276, it would seek seed funding for an accelerator
project or projects located in the United States and managed by a U.S.
subsidiary. Iotron has not entered into any partnerships to pursue this
endeavor to date, but it is open to collaborating with others if
appropriate.
iotron's accelerator technology
Iotron's Electron Beam accelerator technology can be used to
produce medical isotopes such as Moly-99. The technical viability of
this production route was demonstrated more than 10 years ago at a
number of research institutes. To make production possible on a
commercial scale requires the use of high-power and high-energy
electron beam accelerators. We propose to use the IMPELA technology
developed by AECL and owned by Iotron. IMPELA is a unique technology
regarded as the first commercial electron beam accelerator capable of
generating both high-energy and high-power levels and has won several
awards, including the R&D 100 Award. This accelerator technology is
entirely conventional and is proven to be effective in a commercial
environment, with simple servicing requirements and high uptime and
reliability.
The photonuclear process uses high-energy photons generated in a
photo-convertor to drive the nuclear transmutation of stable Moly-100
to the radioisotope Moly-99. The photons are created when the electron
beam is slowed in a photo-convertor creating so-called Bremsstrahlung
(braking radiation). Such convertors are routinely employed on
commercial electron beam accelerators used to sterilize some medical
goods and foodstuffs. In the photonuclear process these photons
irradiate a molybdenum target to create Moly-99 by the (gamma,n)
reaction.
benefits of accelerator production of moly-99
There are many benefits to using an accelerator for producing Moly-
99 and other medical isotopes compared with other methods. First, the
capital and operating costs of using a reactor for this purpose are
avoided. Neither high-enriched nor low-enriched uranium is needed for
an accelerator process to produce Moly-99 since it is not based on
fission of uranium. In addition, the time necessary to move from the
design and development phase to construction and production, including
regulatory approvals, is relatively short for an accelerator-based
solution; we estimate some two to three years.
Other benefits are that the accelerator production of Moly-99
generates minimal radioactive waste compared to the current fission
method. Such wastes require disposal at considerable cost. In addition,
the use of a number of accelerators located at various locations
provides the redundancy to assure a constant supply while reducing
transportation problems and inherent decay loss of the isotopes.
improvements to h.r. 3276
The text of H.R. 3276 does not bar DOE from providing financial
assistance to a project using accelerator technology to produce Moly-
99. However, the bill text refers repeatedly and specifically to
reactors and does not mention accelerators or any other non-reactor
technology. In addition, the phrase ``Medical Isotope Development
Projects'' is not defined. Therefore, the current legislative text
could potentially be misconstrued by DOE to imply a Congressional
preference for reactor solutions to the Moly-99 shortage.
Iotron is grateful to the authors of H.R. 3276 for the following
language that was included in the House Committee Report, which
specifically addresses the need for a level playing field for all
potential technologies considered by DOE for funding support. The
Committee Report states:
The Committee recognizes that there are a variety of
potential technological options for the production of
molybdenum-99. The Committee emphasizes that H.R. 3276 does not
favor any particular technology to receive funding as a medical
isotope development project. Instead, it is the intent of the
Committee that the Department of Energy support molybdenum-99
production projects in a technology neutral manner, choosing to
assist those projects that best meet the criteria in section
3(a)(2) of H.R. 3276.
This report language is excellent and squarely addresses Iotron's
concern. However, Iotron respectfully requests that when this Committee
acts on H.R. 3276 that it include the ``technology neutral''
requirement for DOE funding in the legislative text, not only in the
Senate Committee Report.
Iotron also recommends that the criteria in Section 3(a)(2) of H.R.
3276 for the evaluation of Medical Isotope Development Projects could
be improved with the additional clarification that ``waste disposal''
costs must be considered when estimating project costs. These costs are
likely to be substantial for certain Moly-99 production technologies
and must be factored into any DOE cost estimate and comparison.
conclusion
Iotron again thanks the Committee for the opportunity to file
testimony for the record regarding H.R. 3276. If the Committee has any
questions regarding our testimony or related matters, please do not
hesitate to contact us.