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74–094 2012

SOLVING THE MEDICAL ISOTOPE CRISIS 

HEARING 

BEFORE THE

SUBCOMMITTEE ON ENERGY AND ENVIRONMENT 

OF THE

COMMITTEE ON ENERGY AND 

COMMERCE 

HOUSE OF REPRESENTATIVES 

ONE HUNDRED ELEVENTH CONGRESS 

FIRST SESSION 

SEPTEMBER 9, 2009 

Serial No. 111–61 

( 

Printed for the use of the Committee on Energy and Commerce 

energycommerce.house.gov 


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COMMITTEE ON ENERGY AND COMMERCE 

HENRY A. WAXMAN, California, Chairman 

JOHN D. DINGELL, Michigan 

Chairman Emeritus 

EDWARD J. MARKEY, Massachusetts 

RICK BOUCHER, Virginia 

FRANK PALLONE, JR., New Jersey 

BART GORDON, Tennessee 

BOBBY L. RUSH, Illinois 

ANNA G. ESHOO, California 

BART STUPAK, Michigan 

ELIOT L. ENGEL, New York 

GENE GREEN, Texas 

DIANA DEGETTE, Colorado 

Vice Chairman 

LOIS CAPPS, California 

MICHAEL F. DOYLE, Pennsylvania 

JANE HARMAN, California 

TOM ALLEN, Maine 

JANICE D. SCHAKOWSKY, Illinois 

CHARLES A. GONZALEZ, Texas 

JAY INSLEE, Washington 

TAMMY BALDWIN, Wisconsin 

MIKE ROSS, Arkansas 

ANTHONY D. WEINER, New York 

JIM MATHESON, Utah 

G.K. BUTTERFIELD, North Carolina 

CHARLIE MELANCON, Louisiana 

JOHN BARROW, Georgia 

BARON P. HILL, Indiana 

DORIS O. MATSUI, California 

DONNA M. CHRISTENSEN, Virgin Islands 

KATHY CASTOR, Florida 

JOHN P. SARBANES, Maryland 

CHRISTOPHER S. MURPHY, Connecticut 

ZACHARY T. SPACE, Ohio 

JERRY MCNERNEY, California 

BETTY SUTTON, Ohio 

BRUCE BRALEY, Iowa 

PETER WELCH, Vermont 

JOE BARTON, Texas 

Ranking Member 

RALPH M. HALL, Texas 

FRED UPTON, Michigan 

CLIFF STEARNS, Florida 

NATHAN DEAL, Georgia 

ED WHITFIELD, Kentucky 

JOHN SHIMKUS, Illinois 

JOHN B. SHADEGG, Arizona 

ROY BLUNT, Missouri 

STEVE BUYER, Indiana 

GEORGE RADANOVICH, California 

JOSEPH R. PITTS, Pennsylvania 

MARY BONO MACK, California 

GREG WALDEN, Oregon 

LEE TERRY, Nebraska 

MIKE ROGERS, Michigan 

SUE WILKINS MYRICK, North Carolina 

JOHN SULLIVAN, Oklahoma 

TIM MURPHY, Pennsylvania 

MICHAEL C. BURGESS, Texas 

MARSHA BLACKBURN, Tennessee 

PHIL GINGREY, Georgia 

STEVE SCALISE, Louisiana 

(II) 


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SUBCOMMITTEE ON ENERGY AND ENVIRONMENT

EDWARD J. MARKEY, Massachusetts, Chairman 

MICHAEL F. DOYLE, Pennsylvania 

G.K. BUTTERFIELD, North Carolina 

CHARLIE MELANCON, Louisiana 

BARON HILL, Indiana 

DORIS O. MATSUI, California 

JERRY MCNERNEY, California 

PETER WELCH, Vermont 

JOHN D. DINGELL, Michigan 

RICK BOUCHER, Virginia 

FRANK PALLONE, JR., New Jersey 

ELIOT L. ENGEL, New York 

GENE GREEN, Texas 

LOIS CAPPS, California 

JANE HARMAN, California 

CHARLES A. GONZALEZ, Texas 

TAMMY BALDWIN, Wisconsin 

MIKE ROSS, Arkansas 

JIM MATHESON, Utah 

JOHN BARROW, Georgia 

RALPH M. HALL, Texas 

Ranking Member 

FRED UPTON, Michigan 

ED WHITFIELD, Kentucky 

JOHN SHIMKUS, Illinois 

HEATHER WILSON, New Mexico 

JOHN B. SHADEGG, Arizona 

STEVE BUYER, Indiana 

GREG WALDEN, Oregon 

SUE WILKINS MYRICK, North Carolina 

JOHN SULLIVAN, Oklahoma 

MICHAEL C. BURGESS, Texas 


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C O N T E N T S 

Page 

Hon. Edward J. Markey, a Representative in Congress from the Commonwealth of Massachussetts, opening statement ................................................... 1 

Hon. Fred Upton, a Representative in Congress from the State of Michigan, 

prepared statement .............................................................................................. 4 

Hon. Jay Inslee, a Representative in Congress from the State of Washington, 

prepared statement .............................................................................................. 46 

Hon. Joe Barton, a Representative in Congress from the State of Texas, 

prepared statement .............................................................................................. 47 

WITNESSES

Parrish Staples, Director, European and African Threat Reduction, Office 

of Global Threat Reduction, National Nuclear Security Administration, 

United States Department of Energy ................................................................. 6 

Prepared statement .......................................................................................... 9 

Answers to submitted questions ...................................................................... 57 

Steven Larson, M.D., Chief, Nuclear Medicine Service, Department of Radiology, Memorial Sloan-Kettering Cancer Center, Vice-Chairman, Committee 

on Medical Isotope Production without Highly Enriched Uranium, National 

Academy of Sciences ............................................................................................ 15 

Prepared statement .......................................................................................... 17 

Answers to submitted questions ...................................................................... 78 

Michael Duffy, Vice President and General Counsel, Lantheur Medical Imaging, Member of the Board, Council on Radionuclides and Radiopharmaceuticals ................................................................................................................ 26 

Prepared statement .......................................................................................... 28 

SUBMITTED MATERIAL

Letter from Director of University of Missouri Research Reactor to Committee .................................................................................................................... 50 

Letter of September 9, 2009, from Washington State University to Mr. Inslee . 54 


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SOLVING THE MEDICAL ISOTOPE CRISIS 

WEDNESDAY, SEPTEMBER 9, 2009 

HOUSE OF REPRESENTATIVES, SUBCOMMITTEE ON ENERGY AND ENVIRONMENT, COMMITTEE ON ENERGY AND COMMERCE, Washington, DC. 

The subcommittee met, pursuant to call, at 2:09 p.m., in Room 

2322, Rayburn House Office Building, Hon. Edward J. Markey 

[chairman of the subcommittee] presiding. 

Present: Representatives Markey, Barrow, Upton, Shimkus, and 

Scalise. 

Staff Present: Jeff Baran, Counsel; Matt Weiner, Special Assistant; and Peter Ketcham-Colwill, Special Assistant. 

OPENING STATEMENT OF HON. EDWARD J. MARKEY, A REPRESENTATIVE IN CONGRESS FROM THE COMMONWEALTH 

OF MASSACHUSETTS 

Mr. MARKEY. Welcome ladies and gentlemen to the Subcommittee on Energy and the Environment and our very important 

hearing. 

Every day in the United States, thousands of people go to the 

hospital to be treated for life-threatening illnesses such as heart 

disease and cancer. But right now, due to the breakdown of a nuclear reactor in Canada, many of these critical procedures are being 

delayed and compromised. 

The United States is facing a crisis in nuclear medicine. We face 

a severe shortage of a crucial radioactive isotope which is required 

for nearly 50,000 medical procedures every day, usually to produce 

a detailed image such as a cancer or a bone scan. The shortage of 

this isotope, which usually costs only $10 of a multi-thousand dollar procedure, is threatening the health care of millions of Americans. Worst of all, the United States does not currently produce 

any of the isotope 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 weapon 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. In mid 

July, the 47-year-old HFR reactor in the Netherlands was taken 

off-line for maintenance for 1 month. Together, these two reactors 

usually produce our entire isotope supply. While the United States 

was able to secure a small supply during this time from other reactors, Americans health care suffered as a result. A recent survey 


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of the nuclear medicine community provided sobering results. 

Eighty percent said their practice was impacted by the shortage. 

Eighty percent said they have postponed procedures. Forty-seven 

percent said they have cancelled procedures, and 57 percent said 

they had substituted alternative procedures. Unfortunately, in 

most cases the alternative procedures are more invasive, less effective, more costly, and pose greater radiation risk to both patients 

and technicians. 

We don’t need alternatives. We need the state of the art to be 

fully available again. Medical care in this country for cancer, heart 

disease, bone scans simply cannot be held hostage to the maintenance schedules of a 50-year-old reactor in Europe. It is absolutely 

vital that we act to bring a robust domestic supply of these critical 

medical isotopes online as soon as possible. 

In order to address the crisis in nuclear medicine, I have introduced, along with my good friend, colleague and partner, Fred 

Upton, H.R. 3276, the American Medical Isotopes Production Act of 

2009. The bill will provide the Department of Energy new authorities and resources to assist the private sector in establishing as 

rapidly as possible a robust medical isotope production capacity 

here in the United States. In addition, the bill will end the export 

of bomb-usable highly enriched uranium for medical isotope production in 7 to 10 years, as recommended in a recent National 

Academy of Sciences report that also said there was no reason that 

these isotopes couldn’t be made using low enriched uranium. In 

fact, both Argentina and Australia have started producing medical 

isotopes with low enriched uranium. Highly enriched uranium is 

nuclear bomb material, and the national security of the United 

States demands that we never export it again. 

The Markey-Upton bill is a bipartisan bill. 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, a list of companies 

as well plus the Nuclear Threat Initiative, the Union of Concerned 

Scientists and Physicians For Social Responsibility. 

I would like to ask for unanimous consent that the letters of endorsement from these organizations be entered into the record. I 

also would like to ask unanimous consent that members will have 

5 legislative days to revise and extend their remarks and to insert 

extraneous material in the record. 

Today’s hearing will allow the subcommittee to explore this important issue and to hear the panel’s views on H.R. 3276. I hope 

that we can all work together to address this crucial problem facing 

American hospitals and patients. 

Now I would like to turn and recognize my good friend, the gentleman from Michigan, Mr. Upton for his opening statement. 

Mr. UPTON. Thank you, Mr. Chairman. I am going to ask unanimous consent that my full statement be made part of the record. 

And trying to shorten up some of the time as we are expecting 

votes soon, let me just make a couple of comments. We are really 

at a crisis. As you indicated, 16 million medical procedures in the 

U.S. that rely on the import of Moly-99. That’s 50,000 a day. It is 


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clear that our Nation must produce these lifesaving isotopes domestically to ensure that the public health is protected. And when 

I learned of this situation when you and I talked about it in July 

before the August break, I was delighted to partner with you to introduce legislation that I hope can move quickly. 

There are a good number of organizations that are onboard. I 

would like to think that this hearing will catapult us into getting 

a bill to the House very soon. And at this point, I yield back the 

balance of my time. 

[The prepared statement of Mr. Upton follows:] 


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Mr. MARKEY. Thank you. The Chair recognizes the gentleman 

from Illinois. 

Mr. SHIMKUS. I will waive. 

Mr. MARKEY. The Chair recognizes the gentleman from Louisiana. 

Mr. SCALISE. I will waive. 

Mr. MARKEY. That is great. We will recognize our very distinguished panel. Our first witness is Dr. Parrish Staples, director of 

the Office of European and African Threat Reduction at the National Nuclear Security Administration of the Department of Energy. Dr. Staples has played a leading role within the Department 

of Energy to help solve the medical isotopes crisis. In addition, his 

office is responsible for implementing the Department of Energy’s 

efforts to reduce the use of highly enriched uranium around the 

world including in the production of medical isotopes. 

STATEMENTS OF PARRISH STAPLES, DIRECTOR, EUROPEAN 

AND AFRICAN THREAT REDUCTION, OFFICE OF GLOBAL 

THREAT REDUCTION, NATIONAL NUCLEAR SECURITY ADMINISTRATION, UNITED STATES DEPARTMENT OF ENERGY; 

STEVEN LARSON, M.D., CHIEF, NUCLEAR MEDICINE SERVICE, DEPARTMENT OF RADIOLOGY, MEMORIAL SLOAN-KETTERING CANCER CENTER, VICE-CHAIRMAN, COMMITTEE ON 

MEDICAL ISOTOPE PRODUCTION WITHOUT HIGHLY ENRICHED URANIUM, NATIONAL ACADEMY OF SCIENCES; AND 

MICHAEL DUFFY, VICE PRESIDENT AND GENERAL COUNSEL, 

LANTHEUR MEDICAL IMAGING, MEMBER OF THE BOARD, 

COUNCIL ON RADIONUCLIDES AND RADIOPHARMACEUTICALS 

Mr. MARKEY. We welcome you, Dr. Staples. Whenever you’re 

ready please, again. 

STATEMENT OF PARRISH STAPLES 

Dr. STAPLES. Thank you, Chairman Markey, Ranking Member 

Upton, and the subcommittee members. Thank you for the opportunity to testify on the National Nuclear Security Administration’s 

Global Threat Reduction Initiative’s role in minimizing, and to the 

extent possible, eliminating the use of highly enriched uranium in 

civilian nuclear applications including in the production medical 

radioisotopes. As part of my testimony, I will briefly describe recent 

efforts to mitigate the impact of the current and anticipated shortages of the medical isotope moly-99 and discuss in more detail our 

efforts to accelerate the establishment of a domestic commercial 

supply of moly-99 that does not use highly enriched uranium. 

Finally, I will highlight how the proposed American Medical Isotopes Production Act of 2009 can greatly help to advance our 

progress on the dual U.S. policy priorities to, one, establish a secure supply of this critical medical isotope for U.S. citizens, and 

two, to minimize the civilian use of proliferation-sensitive highly 

enriched uranium around the globe. 

First, section 2 of the American Medical Isotope Production Act 

of 2009 very appropriately and succinctly covers the history, the 

use of moly-99, the decay product technecium-99 nine, the issues 


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surrounding the current medical isotope production industry, the 

current acute shortage of moly-99 within the medical community, 

and the critical importance that this isotope provides to the health 

care of Americans on a daily basis. And most importantly, it also 

covers the state of the art technology regarding conversion to low 

enriched uranium. 

Very important to us, on January 14, 2009, the National Academy published a report confirming that the production of moly-99 

without the use of highly enriched uranium is both technically and 

economically feasible. In addition to the National Academy’s determination that there are no technical reasons that adequate quantities of medical isotope cannot be produced without the use of 

HEU, the National Academy also stated that the single greatest 

threat to the supply reliability is the approaching obsolescence of 

the aging reactors that current large-scale producers utilize to irradiate HEU targets to obtain moly-99. The findings of this report 

unambiguously support the consistency of HEU minimization policies with the full-scale production of medical isotopes while highlighting the fragile nature of the current supply chain due to the 

age of the foreign moly-99 production facilities. 

Now, with our mission to reduce and eliminate the use of HEU 

in civilian applications NNSA has been working for many years to 

convert research reactors from the use of HEU to LEU fuel. We 

agree with the language in the proposed legislation which makes 

clear that the U.S. should accelerate its effort to convert HEU research reactors worldwide from the use of HEU. In fact, this acceleration is already underway at NNSA. 

We and the Global Threat Reduction Initiative have significantly 

accelerated our efforts over the past several years and to date have 

converted 57 highly enriched uranium fuel research reactors globally from the use of HEU to LEU fuels. Through GTRI efforts, another seven HEU research reactors have been verified to shut down 

prior to their conversion. These activities have resulted in more 

than 320 kilograms of HEU no longer being used annually for reactor operations. 

In addition, NNSA has also been working with both existing and 

potential moly-99 producers for several years to convert or develop 

their moly-99 production processes to utilize non-HEU-based technologies. NNSA provides technical expertise on a nonproprietary 

basis to all existing and potential producers to assist in converting 

and developing their moly-99 production processes in accordance 

with the U.S. HEU minimization policy. Through these efforts 

NNSA has established longstanding relationships with current and 

future moly-99 suppliers and we are uniquely suited to accelerate 

efforts to establish a reliable domestic supply without the use of 

HEU. Due to the current lack of global production capacity of moly99 by industry, we are actively engaging in discussions with all 

current and possible producers to best determine how to rapidly 

transform the industry into a diverse, stable, commercial supply 

network that will not use HEU for production of this vital medical 

isotope. 

Given the market dynamics with the current supply shortage, we 

fully expect that the 7-year timeframe referenced in the American 

Medical Isotopes Production Act of 2009 is more than adequate to 


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ensure that a sufficient supply of non-HEU moly-99 can be available to the medical community. Further we believe that the development of new producers or the conversion of existing producers to 

low enriched uranium can be accomplished with no impact upon 

the current supply availability. In fact, through the current acute 

supply shortage of this critical medical isotope and the associated 

market dynamics with the focus of the American Medical Isotopes 

Production Act of 2009 on this issue, we believe that we can ensure 

the successful development of a diverse, reliable supply of moly-99 

to the medical community that will also help to accomplish an important and longstanding nuclear nonproliferation mission. 

Now, the United States has approached the moly-99 supply problem by—— 

Mr. MARKEY. If you could summarize please, Dr. Staples. 

Dr. STAPLES. I would just go to my closing paragraph then. The 

American Medical Isotope Production Act of 2009 is crucial of ensuring the success of our efforts to accelerate development of a domestic supply of moly-99 nine without the use of HEU. This legislation will accelerate greatly and enhance the development of reliable 

supply of this isotope for the use in the U.S. medical community 

and further support U.S. objectives to reduce the use of proliferation-sensitive HEU in civilian applications. 

I thank the subcommittee and Chairman Markey, in particular, 

for your continued leadership on such a crucial nuclear energy and 

civil nuclear application issue, and we stand ready to answer questions. 

Mr. MARKEY. Thank you, sir. 

[The prepared statement of Dr. Staples follows:] 


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Mr. MARKEY. Our second witness is Dr. Steven Larson the Chair 

of the Nuclear Medicine Service, Department of Radiology at the 

Memorial Sloan-Kettering Cancer Institute. Whenever you are 

ready, please begin. 

STATEMENT OF STEVEN LARSON, M.D. 

Dr. LARSON. Good afternoon, chairman and members of the committee. My name is Steven Larson, and I am chief of nuclear medicine, as you have heard at Memorial Sloan-Kettering Cancer Institute in New York. I also served as vice chair of the National Research Council’s Committee on medical isotope production without 

highly enriched uranium. I was asked to testify today regarding 

the report from the study, but first I want to offer some personal 

observations as a practicing nuclear medicine physician. 

I am the director of a large nuclear medicine clinic at Memorial 

Sloan-Kettering Cancer Center. For most of the summer like other 

nuclear medicine clinics in the northeast, we have seen a reduction 

of 20 to 25 percent in the optimum amount of technetium for clinical use. Now, technetium 99m, as you have heard, is by far the 

most common clinical isotope and a bellwether for nuclear medicine 

isotope supplied health care. This reduction supply has negatively 

impacted our ability to efficiently deliver nuclear medicine-based 

care to patients. 

Furthermore, medical isotope providers are telling us to expect 

continued shortages of technetium 99m during 2009 and beyond, 

and they are warning about the possibility of even deeper reductions in technetium 99m availability. Clearly we are in the need of 

a more reliable supply of medical isotope for American health care. 

Let me turn to the National Research Council’s study on medical 

isotope production without highly enriched uranium. The mandate 

for this study came from section 630 of the Energy Policy Act of 

2005. Our study was completed in late 2008, and the final report 

was issued in January, 2009. It focused primarily on the use of 

HEU for the production of medical isotope molybdenum 99. 

Briefly, some key findings. Adequate quantities of medical isotopes to meet U.S. demands could be produced without HEU. A report found that an 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. Reliability of medical isotope supply is a significant problem now and likely to be a problem for the foreseeable future with 

demand close to total capacity for production and with little margin 

for additional production capacity in the event of an interruption 

of supply. 

On the other hand demand for nuclear medicine services are stable with likely growth rates of utilization of 3 to 5 percent per year. 

Several steps could be taken by the U.S. Government and others 

to improve the feasibility of eliminating the use of HEU for medical 

isotope production. I note that H.R. 3276 legislatively enshrines 

several of these steps. It authorizes the Department of Energy to 

provide technical assistance to producers who wish to convert to 

production without HEU. It provides financial assistance to develop 

a domestic isotope production capacity, and it provides for a 7-year 

phaseout period for HEU exports for medical isotope production. 


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When I began work on this study I was skeptical about the economic feasibility of conversion to LEU-based medical isotope production and the potential impact that that might have on conversion or supply reliability. But based on the information I received 

during this National Research Council study, I now believe that if 

medical isotope producers have the will to convert that, they can 

do so without undue costs. My opinion is based on the observations 

we made during the site visits to the medical isotope production facilities in Argentina and Australia and discussion with technical 

experts about conversion. Under modest circumstances and without 

elaborate additional infrastructure, Argentina was able to convert 

to LEU-based production in less than 2 years and for less than a 

million dollars in supplies and facilities modification. 

The Argentina process is now being implemented in Australia 

and the Australian company, ANSTO, hopes to begin exporting 

small quantities of molybdenum 99 to the United States in the 

near future. 

This concludes my oral testimony to the committee and I would 

be pleased to answer any questions. 

Mr. MARKEY. Thank you so much, Dr. Larson. 

[The prepared statement of Dr. Larson follows:] 


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Mr. MARKEY. And our final witness is Michael Duffy, vice president and general counsel of Lantheus Medical Imaging, one of only 

two U.S. manufacturers of these type of generators. Welcome, sir. 

STATEMENT OF MICHAEL DUFFY 

Mr. DUFFY. Good afternoon, Mr. Chairman, Mr. Upton, members 

of the committee, staff. I am here today to testify on behalf of the 

bill on behalf of both Lantheus and CORAR, the Council on Radionuclides and Radiopharmaceuticals. Lantheus endorses H.R. 3276. 

We strongly support the committee’s efforts to promote the protection of moly in the United States for medical isotope applications. 

We have been a worldwide leader in diagnostic medical imaging for 

the past 50 years. Lantheus is the home to leading diagnostic imaging brands, including the Technelite generator which I have for 

those who want to take a look, and this is what actually causes 

the—the radioactive salient is put through here. It comes out here 

and is mixed with a powder and becomes the injection which is injected into the patient. 

So what’s so important about these imaging agents, these radionuclides? They allow a clinician to have a functional view of an 

organ like the heart more than just a mere anatomical image. Instead, a picture from the outside looking in, they allow the physician to see what is inside projecting out, for example, blood flow, 

heart function, tissue health. These are extremely helpful and important in the diagnosis and treatment of disease. The moly supply 

crisis is a chronic crisis resulting from an aging supply infrastructure and a market failure to attract sufficient replacement capacity. As Chairman Markey said, the crisis has become acute because 

of the ongoing shutdown in Canada at the NRU reactor and the ongoing repairs in the Netherlands at the HFR reactor. Although 

Lantheus has had access to moly supply from the major moly-producing reactors around the world, because of this crisis, we have 

not been fully able to meet our customers’ needs and we are having 

to ration the generators on a weekly basis. 

Approximately a third of the moly manufactured outside of North 

America decays before it reaches our manufacturing facility in 

Massachusetts. Some of the old hands at Lantheus refer to this as 

buying ice on a warm day. Lantheus believes that a robust U.S. 

Supply of moly is an important U.S. policy for reasons of accessible 

and affordable health care, efficient waste management, and nuclear nonproliferation. 

As a result of the moly supply crisis, important diagnostic procedures are being postponed or cancelled. Clinicians are turning to 

older nuclear isotopes with potentially less diagnostic certainty and 

more patient risk. Clinicians may even be foregoing nuclear medicine entirely, opting instead for more invasive, more expensive, 

higher risk surgical procedures. Lantheus believes that the private 

sector should have a major role in the resolution of this issue. However, we also believe there is a strong role for government to play. 

The U.S. Government’s financial support of multiple projects with 

appropriate investment risk profiles will be the best way to develop 

a robust domestic supply of moly. And as a matter of health care 

policy, medical imaging procedures that rely on moly-derived imaging agents can improve patient outcomes and reduce costs. StraVerDate Mar 15 2010 05:05 Aug 16, 2012 Jkt 074094 PO 00000 Frm 00032 Fmt 6633 Sfmt 6633 E:\HR\OC\A094.XXX A094

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tegic investments to help develop a domestic supply of moly should 

pay large dividends for both U.S. patients and U.S. taxpayers. 

Wearing my CORAR hat now, CORAR supports H.R. 3276 and 

increasing capacity for medical isotopes in the United States. 

CORAR has two concerns about the bill. First, how do we ensure 

a full supply of moly if we get to the 7- to 10-year period and we 

don’t yet have sufficient commercial quantities of domestically-produced LEU available? Second, CORAR would like the bill to contain specific language that would direct the Nuclear Regulatory 

Commission to allow the new aqueous homogenous reactors which 

have been recently proposed to be properly licensed as research reactors. CORAR believes the bill provides good support to bring new 

and alternative supplies to moly online quickly and believes it is 

prudent to back several alternative technologies and multiple reactor sites in order to avoid a repeat of the current availability in capacity issues. 

In sum, as H.R. 3276 moves forward, both Lantheus and CORAR 

hope to continue to work with the committee and staff to ensure 

both a swift and long-term solution to the moly crisis. 

Thank you for the consideration of our perspectives. We look forward to working with you moving forward and I would be glad to 

answer any questions. 

[The prepared statement of Mr. Duffy follows:] 


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Mr. MARKEY. They have called four roll calls on the House floor. 

There are 10 minutes left to go before we have to go to that roll 

call. Let me recognize the gentleman from Michigan, Mr. Upton. 

Mr. UPTON. Thanks. 

I have one very quick question, and that is the bill as you know 

has a 7- to 10-year timeframe. Do you think that is long enough? 

Is that the right amount of time or should we look at extending 

that? Go ahead, Mr. Duffy, Dr. Larson too. 

Mr. DUFFY. The National Academies had a point of view on that, 

and I welcome Dr. Larson’s views on that. The concern that industry has about the timeframe is one of technology and one of regulation. On the technology side can we design targets appropriately 

which generate commercially sustainable amounts of molybdenum 

and can we do this in a way that is going to pass muster with the 

EPA, the Nuclear Regulatory Commission, the FDA and all the 

other State and Federal regulatory authorities? Industry embraces 

the proposal, is going to work hard to try to implement it, but 

CORAR, in particular, is concerned that for reasons beyond its control the period may not be sufficient. 

Mr. UPTON. Dr. Larson. 

Dr. LARSON. The main report felt that after careful deliberation 

that it would be feasible to bring this conversion in a 7-year timeframe; however, it does depend on the actual type of conversion 

that was required. If one was talking about a complete refilled new 

facility, it may, in fact, take a bit longer. So we can—my feeling 

is that the 7 years is probably enough especially with the 3-year 

window that is offered. The committee does have expertise to bring 

to bear upon this, and if you wish, we can certainly review this 

issue and give you a more full description of it since it is such a 

key. 

Mr. UPTON. That would be great. If you would like to do that 

that would be great. I will yield back. 

Mr. MARKEY. Let me just ask one question, Dr. Larson. The National Academy of Sciences report recommended that Congress set 

a deadline to end the export of HEU for medical isotope. The report 

concluded that a 7- to 10-year phaseout period would likely allow 

enough time for all current HEU-based producers to convert to low 

enriched uranium. How did you arrive at that conclusion of 7 to 10 

years? 

Dr. LARSON. I think the conclusion was based on interviews, discussions, field trips, and reviews of time of development of new facilities. We had the opportunity to visit, for example, Australia and 

to observe their process and plan for this. But since this is such 

a key point, we certainly would be glad to provide some more detailed background on how this was arrived at. 

Mr. MARKEY. Thank you, sir. The gentleman from Georgia. 

Mr. BARROW. No questions. 

Mr. MARKEY. Thank you. 

Dr. Staples, I am going to ask you what I think is the single 

most important question and that is how long will it take for the 

U.S. industry with the help of the Department of Energy to establish a robust domestic supply without the use of HEU? 

Dr. STAPLES. Thank you. We believe that to develop a robust supply without the use of HEU would take on the order of 5 years with 


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the type of attention focus that this bill could bring to the industry 

and the issue given the acute shortage of this isotope we are currently experiencing. As a clarification, we are not just talking about 

conversion of existing facilities. We are talking about looking at a 

diverse reliable supply network that would be implemented using 

non-HEU, not just LEU fission target-based technologies. 

Mr. MARKEY. Dr. Staples, is DOE working with the foreign medical isotope producers to help them convert from HEU to LEU? 

Dr. STAPLES. In fact, yes, we are. Given the recent supply shortage, we have engaged in at least informal discussions with all current producers regarding options and process and procedure for the 

conversion—— 

Mr. MARKEY. Have they asked for your help in conversions? 

Dr. STAPLES. Yes. They have solicited our help and assistance in 

conversions. 

Mr. MARKEY. Have they made those requests recently? 

Dr. STAPLES. As recently as last week, yes sir. 

Mr. MARKEY. Great. Does there seem to be a renewed interest in 

converting from HEU to LEU at this time? 

Dr. STAPLES. Absolutely. Again, I think primarily driven by the 

shortage of supply in the current industry. 

Mr. MARKEY. Would phaseout of export of HEU for medical isotope production in 7 to 10 years given the handful of foreign producers present a window of opportunity for their operations? 

Dr. STAPLES. If I understand, we believe that the 7-year timeframe would give more than a sufficient timeframe for these facilities to work on conversion and for the development of a diverse domestic supply of moly 99 not using enriched uranium. 

Mr. MARKEY. Does 7 to 10 years give the foreign producers adequate time to convert to LEU? 

Dr. STAPLES. Yes. 

Mr. MARKEY. The bill authorizes $163 million over 5 years for 

DOD to help establish a domestic supply. Is that the right of 

amount of money and is that the right amount of time? 

Dr. STAPLES. Yes. We believe that is consistent with a program 

plan that we have in place where we would intend this year to 

place up to $10 million on programs to support the development of 

commercial industry and $30 million in each of the respective outyears to support the developments of domestic and/or commercial 

supply of isotope. 

Mr. MARKEY. I have a group of other written questions here, and 

I am going to submit to you each for your response to the committee. We apologize to you. There is a whole series of roll calls 

which are House floor. We apologize to you for that, and with the 

thanks of the subcommittee and apologies because of the truncated 

form of the hearing, this hearing is adjourned. Thank you. 

[Whereupon, at 2:42 p.m., the subcommittee was adjourned.] 

[Material submitted for inclusion in the record follows:] 


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