[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


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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

                              ----------                              

                               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

                              ----------                              


                       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.
---------------------------------------------------------------------------
    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.
---------------------------------------------------------------------------
    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.

                                    

      
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