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65–421 PDF 2011

S. HRG. 112–4 

THE AMERICAN MEDICAL ISOTOPES 

PRODUCTION ACT 

HEARING 

BEFORE THE

COMMITTEE ON 

ENERGY AND NATURAL RESOURCES 

UNITED STATES SENATE 

ONE HUNDRED TWELFTH CONGRESS 

FIRST SESSION 

TO

RECEIVE TESTIMONY ON S. 99, THE AMERICAN MEDICAL ISOTOPES 

PRODUCTION ACT OF 2011 

FEBRUARY 1, 2011 

( 

Printed for the use of the 

Committee on Energy and Natural Resources 
(II) 

COMMITTEE ON ENERGY AND NATURAL RESOURCES 

JEFF BINGAMAN, New Mexico, Chairman 

RON WYDEN, Oregon 

TIM JOHNSON, South Dakota 

MARY L. LANDRIEU, Louisiana 

MARIA CANTWELL, Washington 

BERNARD SANDERS, Vermont 

DEBBIE STABENOW, Michigan 

MARK UDALL, Colorado 

JEANNE SHAHEEN, New Hampshire 

AL FRANKEN, Minnesota 

JOE MANCHIN, III, West Virginia 

CHRISTOPHER A. COONS, Delaware 

LISA MURKOWSKI, Alaska 

RICHARD BURR, North Carolina 

JOHN BARRASSO, Wyoming 

JAMES E. RISCH, Idaho 

MIKE LEE, Utah 

RAND PAUL, Kentucky 

DANIEL COATS, Indiana 

ROB PORTMAN, Ohio 

JOHN HOEVEN, North Dakota 

BOB CORKER, Tennessee 

ROBERT M. SIMON, Staff Director 

SAM E. FOWLER, Chief Counsel 

MCKIE CAMPBELL, Republican Staff Director 

KAREN K. BILLUPS, Republican Chief Counsel 
(III) 

C O N T E N T S 

STATEMENTS 

Page 

Bingaman, Hon. Jeff, U.S. Senator From Mexico ................................................. 1 

Brown, Roy W., Senior Director, Federal Affairs, Council on Radionuclides 

and Radiopharmaceuticals .................................................................................. 7 

Doane, Margaret M., Director, Office of International Programs, Nuclear Regulatory Commission ............................................................................................. 13 

Murkowski, Hon. Lisa, U.S. Senator From Alaska ............................................... 2 

Staples, Parrish, Ph.D., Director, Office of European and African Threat 

Reduction, Global Threat Reduction Initiative, Defense Nuclear Nonproliferation, National Nuclear Security Administration, Department of Energy ........................................................................................................................ 3 

APPENDIXES 

APPENDIX I 

Responses to additional questions .......................................................................... 25 

(1) 

THE AMERICAN MEDICAL ISOTOPES 

PRODUCTION ACT 

TUESDAY, FEBRUARY 1, 2011 

U.S. SENATE, COMMITTEE ON ENERGY AND NATURAL RESOURCES, Washington, DC. 

The committee met, pursuant to notice, 9:59 a.m. in room SD– 

366, Dirksen Senate Office Building, Hon. Jeff Bingaman, chairman, presiding. 

OPENING STATEMENT OF HON. JEFF BINGAMAN, U.S. 

SENATOR FROM MEXICO 

The CHAIRMAN. Why don’t we get started. Thank you all for 

being here. This is a hearing of the Senate Energy and Natural Resources Committee. Let me first, before we get started, welcome 

Senator Manchin, who has just joined our committee. As other 

newly assigned members come to the committee, we will certainly 

welcome them as well. But we’ll have our first sort of organizing 

meeting probably in a week or 2 to discuss committee assignments 

and all of that. 

Today’s hearing is on S. 99. That is the American Medical Isotopes Act of 2011. This bill is essentially the same bill that was reported out of this committee last Congress by unanimous consent, 

except that the program authorization has been lowered by $20 

million to account for the fact that we are now in fiscal year 2011. 

The purpose of the legislation is to develop a reliable domestic 

supply of Molybdenum-99, which is used for 18 million, or 85 percent, of the medical isotope procedures performed annually in the 

United States. We currently have no domestic supply of this isotope 

and we rely on aging reactors in Canada and Europe to produce it. 

For the first time, the reactors in Canada and Europe were shut 

down last July and August for maintenance. That resulted in days 

when you could not get a Molybdenum-99 procedure. 

This bill will correct the problem by authorizing the Department 

of Energy to work with U.S. companies to produce a reliable domestic supply of Molybdenum-99 in order to avoid a future shortage. The bill also proposes a 14-year phaseout of exporting of highly enriched uranium, which is used to produce these isotopes. 

It seems to me that since we’re now negotiating with Iran to supply their medical isotope reactor with low enriched fuel, we ought 

to lead by example and phaseout the export of the weapons-grade 

uranium to produce these isotopes. The technology exists to 

produce Molybdenum-99 from low enriched uranium. South Africa 

and Australia are currently doing so. This bill authorizes the De-
2 

partment of Energy to enter into cooperative agreements and for 

U.S. companies to do so as well. 

I want to thank the witnesses who are appearing today. Two of 

the witnesses testified on this bill in the last Congress. Dr. Staples, 

Mr. Brown, I thank you for appearing again today. Ms. Doane is 

the technical expert from the Nuclear Regulatory Commission, 

which has submitted formal written comments on the bill. She will 

not have an opening statement today, but will be at the witness 

table to answer any questions on how the Nuclear Regulatory Commission manages the export of special nuclear materials such as 

the highly enriched uranium used to produce Molybdenum-99. 

Let me call on Senator Murkowski for any statement she’d like 

to make. 

STATEMENT OF HON. LISA MURKOWSKI, U.S. SENATOR 

FROM ALASKA 

Senator MURKOWSKI. Thank you, Mr. Chairman. It’s good to be 

back at the committee. 

I would also like to welcome our new members on your side, Senator Franken and Senator Manchin. I think you will find this is a 

committee where we jump into the interesting, complex, sometimes 

contentious issues with great relish, but do so with a degree of civility, honesty, and attention to the work that yields good product. 

I think you’ll enjoy the committee. 

We have a handful of new members joining on our side of the 

aisle. They are Senator Lee, Senator Paul, Senator Coats, Senator 

Portman, Senator Hoeven. We have a good group of members. 

As you point out, Mr. Chairman, our committee has had an opportunity to review the issue of the supply of nuclear medical isotopes, but in fairness to our new members, it is important that we 

do some reruns. We’ll be seeing some of these as we proceed in the 

early part of this year, but very important issues. 

For those of you that are joining us here today, the chairman and 

I were discussing the new lighting. Apparently, I’m told that we 

are the first committee room in the Congress to be fully installed 

with the new LED lights. Of course we like them, because they are 

more energy efficient, but they do cast a different pall on the rest 

of you out there. 

I do want to thank you for scheduling this hearing. 

The CHAIRMAN. Next we’re going to see if we can get some heat 

in the room—our next renovation. 

[Laughter.] 

Senator MURKOWSKI. One step at a time, sir. 

You have given some good background on the issue relating to 

our domestic supply of nuclear medical isotopes, the fact that we 

have not had here in this country a domestic supply since 1989. We 

saw the shortages play out in 2009 and 2010 within our medical 

communities. I understand that, while the supply currently is 

meeting a growing demand, the stability and the long-term viability of that supply is in question. 

The bill before us seeks to help promote the domestic production 

of Mo-99 to meet our country’s needs. It’s been just over a year that 

we had the hearing on this subject. I look forward to hearing from 

you, Dr. Staples and Mr. Brown, the progress that has been made 
3 

thus far in moving toward a more domestic supply; and also interested in hearing what changes you believe may be needed to the 

legislation that we discussed last year. 

With that, I look forward to the comments. 

The CHAIRMAN. All right. Let me also join in welcoming Senator 

Franken. We’re glad he’s on the committee and look forward to his 

active participation. 

Dr. Parrish Staples is the Director of the Office of European and 

African Threat Reduction with the Global Threat Reduction Initiative, Defense Nuclear Nonproliferation, at the National Nuclear Security Administration in the Department of Energy. Mr. Roy Brown 

is the Senior Director of Federal Affairs with the Council on Radionuclides and Radiopharmaceuticals. We appreciate both of them 

being here. 

Dr. Staples, why don’t you start and then Mr. Brown, and then 

we’ll have some questions. 

STATEMENT OF PARRISH STAPLES, PH.D., DIRECTOR, OFFICE 

OF EUROPEAN AND AFRICAN THREAT REDUCTION, GLOBAL 

THREAT REDUCTION INITIATIVE, DEFENSE NUCLEAR NONPROLIFERATION, NATIONAL NUCLEAR SECURITY ADMINISTRATION, DEPARTMENT OF ENERGY 

Mr. STAPLES. Thank you, Chairman Bingaman, Ranking Member 

Murkowski, and the other committee members, for the opportunity 

to testify about the National Nuclear Security Administration’s 

support for accelerating the development of a domestic commercial 

supply of Molybdenum-99 without using highly enriched uranium. 

Today I will update you on the testimony provided to this committee in December 2009: first, the nonproliferation and medical 

benefits of S. 99, the American Medical Isotopes Production Act of 

2011; second, NNSA’s progress to accelerate the establishment of 

a non-HEU-based domestic commercial supply of Mo-99; and last, 

the changing global market conditions that could undermine our efforts for reliable domestic production of non-HEU-based Mo-99. 

Currently the United States depends entirely on foreign producers for all of our Mo-99. Of the world’s major international suppliers, Canada, The Netherlands, and Belgium use HEU targets to 

produce this vital medical isotope. Only South Africa, which 

partnered with NNSA to convert its HEU-fueled reactors to low-enriched uranium fuel, has begun LEU-based Mo-99 production. 

NNSA frequently meets with the existing major global producers 

as part of its nuclear nonproliferation agenda to promote the development of a long-term reliable supply of Mo-99 using LEU. World 

leaders at the 2010 Nuclear Security Summit and other fora underscored the need to minimize and, where possible, eliminate the use 

of HEU due to the grave threats posed by excess nuclear materials 

and the possible acquisition of such materials by terrorists or rogue 

States. 

As has been the case in 2009–2010, global shortages can occur 

with any change in the production schedule of the major producers. 

Under the leadership of the Office of Science and Technology Policy 

of the Executive Office of the President, an inter-agency working 

group which includes NNSA and many others are pursuing actions 

to minimize these near-term shortages. 
4 

The 2009 National Academies report confirmed that production 

of Mo-99 is both technically and economically feasible. As a result, 

NNSA is demonstrating the feasibility of non-HEU-based production by working with four commercial entities to develop technology 

pathways to produce adequate quantities of Mo-99 for the United 

States. These include LEU solution reactor, neutron capture, and 

accelerator-based technologies. The strategy is to move away from 

reliance on a sole technology and a limited number of facilities, as 

is the case with the global Mo-99 market today. 

Now, despite the good progress, challenges remain that could obstruct the successful and accelerated establishment of a domestic 

supply of Mo-99. Just last week I represented the United States at 

the High-Level Group on Medical Radioisotopes hosted by the Organization for Economic Cooperation and Development’s Nuclear 

Energy Agency. I would like to highlight the following main points 

of that discussion: 

First, there is recognition that the current industry has failed 

and that both commercial industry and governments cannot become complacent in their actions to reestablish a reliable supply of 

Mo-99 now that the Canadian and Dutch reactors are once again 

operational. A primary issue is that the major global producers 

have been, and generally continue to be, heavily subsidized by their 

governments. Such subsidies put at risk the economic viability of 

companies starting up high, tech capital-intensive businesses to 

produce non-HEU-based Mo-99. 

To provide a level playing field for U.S. companies, meet our nonproliferation goals, and build a non-HEU-based industry for Mo-99, 

there must be a concerted global commitment that all new or expanded long-term Mo-99 production be undertaken without HEU. 

Very importantly, we must achieve full cost recovery across the entire global commercial industry. Any foreign government subsidy of 

HEU-based production puts the objectives of this legislation at risk. 

We also have significant concerns about the scope, cost, and 

other implications of section 2[c], the Uranium Lease-Takeback 

provision. In addition, that proposed sub-program could risk 

lengthening the timeframe to Mo-99 production if the schedule for 

implementing the proposed Uranium Lease and Takeback sub-program were to have any linkage to the expected production schedule 

of the commercial projects to produce Mo-99. 

NNSA will use its existing well-established program management and procurement oversight tools to ensure that the innovative 

non-HEU-based technologies it supports are developed on schedule 

and that cost-shared funds are properly applied so that Mo-99 is 

delivered to the U.S. market on time and within anticipated costs. 

NNSA will also closely coordinate with the Nuclear Regulatory 

Commission and the Food and Drug Administration on reliability 

issues associated with the commercial use of these technologies. 

To summarize, the Department of Energy and NNSA believe that 

overall this legislation will be helpful in providing public visibility 

to critical nonproliferation goals and to equally critical medical 

needs. With clear commitment and sustained support, we can secure our citizens’ health needs as well as their national security. 

Thank you, Senator Bingaman, Ranking Member Murkowski, 

and other members of the committee for your continued leadership 
5 

in supporting this legislation and we look forward to working with 

you to address any issues raised here today. I appreciate the opportunity to testify and I’m ready to answer your questions. 

[The prepared statement of Mr. Staples follows:] 

PREPARED STATEMENT OF PARRISH STAPLES, PH.D., DIRECTOR, OFFICE OF EUROPEAN

AND AFRICAN THREAT REDUCTION, GLOBAL THREAT REDUCTION INITIATIVE, DE- FENSE NUCLEAR NONPROLIFERATION, NATIONAL NUCLEAR SECURITY ADMINISTRA- TION, DEPARTMENT OF ENERGY

Chairman Bingaman, Ranking Member Murkowski, and Committee Members, 

thank you for the opportunity to testify about the National Nuclear Security Administration’s (NNSA’s) support for accelerating development of a domestic commercial 

supply of Molybdenum-99 (Mo-99) without using highly enriched uranium (HEU). 

This effort is part of our larger global nonproliferation program to minimize and, 

where possible, eliminate the use of HEU in civilian nuclear applications, including 

in the production of medical radioisotopes. My testimony will update you on testimony provided to this committee in December 2009 about (1) the nonproliferation 

and medical benefits of S. 99, the American Medical Isotopes Production Act of 

2011; (2) the NNSA’s progress to accelerate the establishment of a non-HEU based 

domestic commercial supply of Mo-99; and (3) changing global market conditions 

that could undermine our efforts for a reliable domestic production of non-HEUbased Mo-99. 

Mo-99 is the parent isotope of Technetium-99m, which is used in approximately 

50,000 diagnostic medical procedures every day in the United States. It has a very 

short half life and therefore must be produced on a continuous basis to meet the 

needs of the medical community. Any interruptions in production can place patients 

at risk if diagnostic tests cannot be performed. 

Currently, the United States depends entirely on foreign producers for all of its 

Mo-99. Of the major international suppliers of commercial Mo-99, Canada, the Netherlands, and Belgium use HEU targets to produce this vital medical isotope. Only 

South Africa, which partnered with NNSA to convert its HEU reactor to low enriched uranium (LEU) fuel, has begun LEU-based Mo-99 production. 

Mo-99 production processes based on HEU utilize nuclear material enriched to the 

same degree as nuclear material used to produce nuclear weapons and improvised 

nuclear devices. World leaders at the 2010 Nuclear Security Summit and other fora 

underscored the need to minimize and, where possible, eliminate the use of HEU 

due to the grave threats posed by excess nuclear materials and the possible acquisition of such materials by terrorists or rogue states. New technical advances in Mo99 production processes, many of which have been supported by the U.S. Department of Energy and NNSA working closely with industry and our national laboratories, are demonstrating that HEU is no longer required. S. 99, the American Medical Isotopes Production Act of 2011 will encourage Mo-99 suppliers worldwide not 

to use HEU and to develop a reliable supply of Mo-99 for the U.S. medical community. Provisions of this legislation, in particular Section 5, are aligned with the 

NNSA’s nonproliferation mission to assist in the conversion of research reactors and 

isotope production facilities worldwide from the use of HEU to LEU, and to establish a reliable supply of Mo-99 produced without the use of HEU in the United 

States. 

Furthermore, the HEU-free, U.S.-based Mo-99 production encouraged by the 

American Medical Isotopes Production Act of 2011 would serve as an example for 

eliminating HEU in the global medical isotope business. The proposed legislation 

will promote the reliable supply of Mo-99 to hospitals throughout our country and 

will ultimately ensure the level of patient care that our citizens require in a way 

that is consistent with our nuclear nonproliferation goals. 

As has been the case in 2009-2010, global Mo-99 shortages can occur with any 

change in the production schedules of the major producers. Unforeseen shutdowns 

due to technical problems or scheduled maintenance of the aging reactors currently 

producing Mo-99 can threaten the fragile supply chain for the much needed medical 

isotopes. Under the leadership of the Office of Science and Technology Policy of the 

Executive Office of the President, an Interagency working group, which includes 

NNSA and other Department of Energy offices, is pursuing the following actions: 

(1) investigating options to focus on near-term efforts to increase the supply to the 

U.S. during periods when the major suppliers will be out of operation; (2) coordinating efforts to maximize the success of the commercial sector to develop new 

longer-term production capabilities for the U.S. medical community; and (3) working 

with representatives of the medical community to ensure communication about the 
6 

timing of scheduled maintenance to more efficiently manage use of available Mo-99 

supplies. 

NNSA frequently meets with the existing major global Mo-99 producers as part 

of its nuclear nonproliferation agenda to promote the development of a long-term reliable supply of Mo-99 using LEU. NNSA’s programs can also assist other countries 

with conversion, where possible. For example, with NNSA’s support, the South African Nuclear Energy Corporation (Necsa) became the first major supplier to produce 

large-scale quantities of LEU-based Mo-99, and completed its first shipment of FDAapproved, LEU-based Mo-99 to the United States in December 2010. Necsa’s 

achievement to produce large-scale quantities of LEU-based Mo-99 is an important 

nonproliferation advance as it demonstrates the technical viability of producing Mo99 consistent with international commitments to minimize and eliminate the use of 

HEU in isotope production. With appropriate Congressional support, the long-term 

goal of steady state production from LEU could be achieved globally, and could thus 

provide a complementary, consistent supply of the medical isotope to health care 

providers. 

The 2009 National Academies report confirmed that production of Mo-99 is both 

technically and economically feasible, and as a result, NNSA is demonstrating the 

feasibility of non-HEU based Mo-99 production by working with four commercial entities to develop technology pathways to produce adequate quantities of Mo-99 for 

the United States. These include: LEU solution reactor technology; neutron capture 

technology; and accelerator technology. The strategy is to move away from reliance 

on a sole technology and a limited number of facilities, as is the case with the global 

Mo-99 market today. The goal is for each technology to be commercially successful, 

and therefore NNSA’s approach is technology neutral. NNSA also makes available 

to these commercial partners the technical expertise of the U.S. national laboratories gained from their many years of work to develop non-HEU based Mo-99 production technologies. We share the goals of this bill and look forward to working 

with you to ensure the accomplishment of nuclear threat reduction activities and 

the development of a reliable supply of medical isotopes to the public, while ensuring greater Presidential flexibility. 

Despite the good progress, challenges remain that could obstruct the successful 

and accelerated establishment of a domestic supply of Mo-99. First, the major global 

producers have been and continue to be heavily subsidized by their governments. 

Such subsidies put at risk the economic viability of U.S. companies starting up hightech, capital intensive businesses to produce non-HEU based Mo-99. A 2010 independent economic study by the Organization for Economic Cooperation and Development’s Nuclear Energy Agency entitled ‘‘An Economic Study of the Molybdenum-99 

Supply Chain’’, underscores this issue by citing that long-term subsidies have damaged industry’s attempts to enter the global Mo-99 market. To provide a level playing field for U.S. companies, meet nonproliferation goals, and build a non-HEU 

based industry for Mo-99, there must be a concerted global commitment that all new 

or expanded long-term Mo-99 production be undertaken without HEU. Very importantly, we must achieve full cost recovery across the entire global commercial industry. Any foreign government subsidy of HEU-based production puts the objectives 

of this legislation at risk. 

We have significant concerns about the scope, costs, other implications of Section 

2(c), the ‘‘Uranium Lease and Take Back’’ provision. In addition, the proposed program could risk lengthening the timeframe to Mo-99 production if the schedule of 

implementing the proposed ‘‘Uranium Lease and Take Back’’ subprogram were to 

have any linkage to the expected production schedule of the commercial projects to 

produce Mo-99. 

NNSA will use its existing, well-established program management and procurement oversight tools to ensure that the innovative non-HEU based technologies it 

supports are developed on schedule and that cost-shared funds are properly applied 

so that Mo-99 is delivered to the U.S. market on time and within anticipated costs. 

NNSA will also coordinate closely with the Nuclear Regulatory Commission and the 

Food and Drug Administration on regulatory issues associated with the commercial 

use of new technology. 

To summarize, the Department of Energy and NNSA believe that, overall, this 

legislation will be helpful in providing public visibility to critical nonproliferation 

goals and to equally critical medical needs. With clear commitment and sustained 

support, we can secure our citizens’ health needs as well as their national security. 

I thank Senator Bingaman, Ranking Member Murkowski, and Members of the Committee for your continued leadership in supporting this legislation and we look forward to working with you to address any issues raised here today. I appreciate the 

opportunity to testify and am ready to answer your questions. 
7 

The CHAIRMAN. Thank you very much. 

Mr. BROWN. 

STATEMENT OF ROY W. BROWN, SENIOR DIRECTOR, FEDERAL 

AFFAIRS, COUNCIL ON RADIONUCLIDES AND RADIOPHARMACEUTICALS 

Mr. BROWN. Good morning, Mr. Chairman, Ms. Murkowski, 

members of the committee, and staff. My name is Roy Brown and 

I’m Senior Director of Federal Affairs for the Council on Radionuclides and Radiopharmaceuticals, or CORAR. I’m representing 

CORAR here today to testify on behalf of the American Medical 

Isotopes Act of 2011 and to answer questions from the committee. 

CORAR testified before both the Senate and House during the 

last Congress in support of the proposed predecessor legislation, 

H.R. 3276. Thus, we support S. 99 and the provisions contained in 

the legislation. We believe this legislation will provide critical funding, assurance of, and the regulatory framework necessary to establish the reliable medical isotope production capabilities in the U.S. 

This legislation is an important step toward a reliable source of 

medical isotopes for our patients and will contribute to enhancing 

supply well into the future. 

In U.S. hospitals and clinics, Technetium-99m, produced from 

Mo-99, is administered to more than 40,000 patients each day in 

the detection and staging of cancer, detection of heart disease, detection of thyroid disease, study of the brain and kidney function, 

and imaging of stress fractures. Thousands of other nuclear medicine procedures are conducted every day in the U.S. with radionuclides, such as I–131, I–125, You-90 and Xenon-133, in the diagnosis and treatment of diseases. These other isotopes are made as 

a byproduct of the Mo-99 production process. Nuclear medicine procedures not only improve the quality of life, but they save lives. A 

self-sustaining domestic supply of radionuclides used in nuclear 

medicine would ensure our patients receive the necessary care 

while reducing our health care costs. 

As a supporter of S. 99, CORAR would like to highlight four specific issues for the committee’s consideration to ensure that the bill 

will accomplish its goals and serve the needs of U.S. patients. First, 

section 2[c] of the legislation contains an important provision requiring DOE to accept waste created by the production of medical 

isotopes from the DOE-leased uranium. This provision is important 

because currently there’s no disposal pathway available in the U.S. 

for the types of radioactive wastes that will be generated in the 

production of Mo-99 and these other medical isotopes. 

It is critically important to the objective of this legislation that 

DOE accepts such radioactive waste at reasonable prices. These 

prices should be similar to what we would expect to pay for commercial disposal if commercial disposal waste facilities were available. This will help assure new medical isotope production facilities 

can be built and operated effectively. 

Second, the NRC has a comprehensive regulatory framework for 

the protection of the environment, workers, and the public. Any 

new reactor or production facility receiving funding under this legislation will be licensed by the NRC or equivalent Agreement State 

agency. Various aspects and operations of these facilities will also 
8 

be regulated by the Food and Drug Administration, the Department of Transportation, the Environmental Protection Agency, as 

well as State and local regulatory agencies. 

We are concerned that acceptance of money from DOE for the development of medical isotopes for the development of medical isotope capability under this legislation may trigger duplicative nuclear—I’m sorry—National Environmental Policy Act, or NEPA, reviews. With these various levels of regulatory oversight, we do not 

believe NEPA will offer any more protection of the environment 

than already provided by NRC, FDA, DOT, and others. The triggering of NEPA by these new production facilities could seriously 

delay the project, which would not be consistent with the desired 

schedule and would significantly increase its costs. 

The NRC licensing process required for these new facilities is actually a NEPA process. As such, we would like to see NRC as the 

lead agency in the review to avoid a duplicative regulatory process 

which would be created by both NRC and EPA conducting their 

own NEPA review. If the NRC took the lead on this review, these 

new facilities would be required to pass a rigorous environmental 

NEPA review by NRC, while still allowing them to meet the time 

schedule necessary to meet patient demand. 

Several groups are working on the development of new types of 

isotope production reactors or have plans to utilize existing reactors 

for production of medical isotopes. Some of these reactors may fall 

into a licensing gap at NRC. These new reactors do not meet the 

definition of a research reactor under the language in section 4 of 

the Atomic Energy Act due to their production focus and lack of research being conducted there. 

These types of reactors also do not have the inherent risk or security concerns of large commercial nuclear power reactors which 

are licensed under section 103 of the Atomic Energy Act. CORAR 

would like to see S. 99 either revise section 104 of the Atomic Energy Act to recognize these types of reactors for the production of 

medical isotopes or direct the NRC to permit the licensing of these 

reactors under section 104 of the Atomic Energy Act. If assistance 

of this type could be included in the legislation, it would help expedite the licensing of these new reactors and bring these new 

sources of Mo-99 to market more quickly. 

Four, CORAR is aware of several promising efforts to develop 

new medical isotope production technologies. NNSA at DOE has already awarded cooperative grants to a number of projects based on 

different technological approaches. Given this legislation’s intent to 

broadly serve American patients, future funding should be directed 

to the project or projects which stand the best chance of producing 

commercially meaningful quantities of medical isotopes within the 

timeframe envisioned in this legislation. 

We also would like to see the process by which DOE awards development money fully vetted through a regulatory—through a 

rulemaking or some other process where our industry or other interested parties can review and comment on DOE’s proposed evaluation criteria and decisionmaking process for such projects. 

I’d like to thank you for the opportunity to testify here today. 

CORAR is supportive of this legislation and hopes to continue to 

work with the committee and staff to ensure both a swift and long- 
9 

1The 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. 

term solution to the medical isotope supply crisis for the benefit of 

the American patients. 

I’d be happy to answer any questions the committee may have. 

Thank you. 

[The prepared statement of Mr. Brown follows:] 

PREPARED STATEMENT OF ROY W. BROWN, SENIOR DIRECTOR, FEDERAL AFFAIRS, COUNCIL ON RADIONUCLIDES AND RADIOPHARMACEUTICALS, 

Good morning Mr. Chairman, Ms. Murkowski, members of the Committee and 

staff. 

My name is Roy Brown and I am the Senior Director of Federal Affairs for the 

Council on Radionuclides & Radiopharmaceuticals, or CORAR1. I am representing 

CORAR here today to testify on behalf of the American Medical Isotopes Act of 2011 

and to answer questions from the Committee. 

CORAR testified before both the Senate and House during the last Congress in 

support of the proposed predecessor legislation, H.R. 3276. Thus, we support S. 99 

and the provisions contained in the legislation. We believe this legislation will provide critical funding, assurance of, and the regulatory framework necessary to help 

establish reliable medical isotope production capabilities in the United States. This 

legislation is an important step towards a reliable source of medical radionuclides 

for our patients and will contribute to enhancing supply well into the future. In U.S. 

hospitals and clinics, Tc-99m (produced from Mo-99) is administered to more than 

40,000 patients each day in the detection and staging of cancer, detection of heart 

disease, detection of thyroid disease, study of brain and kidney function, and imaging of stress fractures. Thousands of other nuclear medicine procedures are conducted every day in the U.S. with radionuclides, such as I-131, I-125, Y-90 and Xe133, in the diagnoses and treatment of diseases. These nuclear medicine procedures 

not only improve the quality of life, but they save lives. A self-sustaining domestic 

supply of radionuclides used in nuclear medicine would ensure our patients receive 

the necessary care while reducing our health care costs. 

As a supporter of S. 99, CORAR would like to highlight four specific issues for 

the Committee’s consideration to ensure that the bill will accomplish its goals and 

serve the needs of U.S. patients: 

1. Section 3c of the legislation contains an important provision requiring DOE 

to accept waste created by the production of medical isotopes from the DOEleased uranium. This provision is important because currently there is no disposal pathway available in the U.S. for the types of radioactive waste that will 

be generated in the production of Mo-99 and other medical isotopes. It is critically important to the objective of this legislation that DOE accepts such radioactive waste at reasonable prices. These prices should be similar to what we 

would expect to pay for commercial disposal, if a commercial waste disposal facility were available. This will help assure new medical isotope production facilities can be built and operated effectively. 

2. The NRC has a comprehensive regulatory framework for protection of the 

environment, workers and the public. Any new reactor or production facility receiving funding under this legislation will be licensed by the NRC or equivalent 

Agreement State agency. Various aspects and operations of these facilities will 

also be regulated by the Food & Drug Administration (FDA), Department of 

Transportation (DOT) and the Environmental Protection Agency (EPA), as well 

as state and local regulatory agencies. We are concerned that the acceptance of 

money from DOE for the development of medical isotope capability under this 

legislation may trigger duplicative National Environmental Policy Act (NEPA) 

reviews. With these various levels of regulatory oversight, we do not believe 

NEPA will offer any more protection of the environment than that already provided by NRC, FDA, DOT and others. Triggering of NEPA by one of these new 

production facilities could serious delay the project and significantly increase its 

cost. We would like to see a provision in the legislation that any federal money 

spent on the development of medical isotopes to be exempt from the requirements of NEPA. 
10 

3. Several groups are working on the development of new types of isotope production reactors or have plans to utilize existing reactors for production of medical isotopes. Some of these reactors may fall into a licensing gap at the NRC. 

These new reactors do not meet the definition of a research reactor under the 

language in Section 104 of the Atomic Energy Act (AEA), due to their production focus and lack of research being conducted. These types of reactors also do 

not have the inherent risk or security concerns of large commercial nuclear 

power reactors which are licensed under Section 103 of the AEA. CORAR would 

like to see S. 99 either revise Section 104 of the AEA to recognize these types 

of reactors for the production of medical isotopes or direct the NRC to permit 

the licensing of these reactors under Section 104 of the AEA. If assistance of 

this type could be included in the legislation, it would help expedite the licensing of these new reactors and bring these new sources of Mo-99 to market more 

quickly. 

4. CORAR is aware of several promising efforts to develop new medical isotope production technologies. DOE/NNSA has already awarded cooperative 

grants to a number of projects based on different technological approaches. 

Given the legislation’s intent to broadly serve American patients, future funding 

should be directed to the project or projects which stand the best chance of producing commercially meaningful quantities of medical isotopes within the time 

frame envisaged in this legislation. We also would like to see the process by 

which DOE awards development money, fully vetted through a rulemaking or 

some other process where our industry and other interested parties can review 

and comment on DOE’s proposed evaluation criteria and decision-making process for such projects. 

Thank you for the opportunity to testify here today. CORAR is supportive of this 

legislation, and hopes to continue to work with the Committee and staff to ensure 

both a swift and long term solution to the medical isotope supply crisis for the benefit of American patients. 

I would be happy to answer any questions the Committee may have. 

The CHAIRMAN. Thank you both very much. 

Let me start with a few questions here. Dr. Staples, let me understand clearly the position that you articulated about this 

takeback requirement that is in the legislation. Mr. Brown, you’ve 

indicated, I think, the first of the four items that you talk about 

is that it’s very important we keep that provision in there and 

there be some obligation to take this waste back. 

I’m just wondering, Dr. Staples, what is your view on that again? 

You stated it in your testimony, but I wanted to be clear on what 

it is. 

Mr. STAPLES. Our concern is that we cannot anticipate how the 

Uranium Lease Takeback program for the production of Mo-99 actually would be implemented, and the legislation does not provide 

funding for that new service. If directed to do so, we would develop 

an approach that considers the goal of developing a sustainable 

commercial enterprise with thorough diligence for responsible and 

safe materials management. We recognize the importance of meeting those program objectives, but we do require further guidance 

and want to be ensured that the sub-program, the Uranium Lease 

Takeback program, is not linked to the production of medical isotopes, just to ensure the timely development of isotopes for the 

medical community. 

The CHAIRMAN. We may need to look at that language and be 

sure that it meets the requirement that at the same time there is 

an obligation, which Mr. Brown has indicated is very important. 

On the question of how we ensure that the cost of the Molybdenum-99 that U.S. companies are producing or supplying will be 

competitive with that that we obtain overseas, Dr. Staples, what’s 

your view on that? 
11 

Mr. STAPLES. We are concerned about that. We are concerned, in 

fact, of the subsidies provided for the current industry, of how they 

produce the medical isotope, and that our U.S. companies will be 

undercut in the commercial market by foreign producers that are 

heavily subsidized by their governments. This is a serious challenge facing the fragile Mo-99 market and in order to ensure reliable supply we want to ask that a level playing field for all companies be provided, with full cost recovery across the global market. 

This actually is an issue that’s been under discussion with all 

participants, both the suppliers and the customers, at the recent 

Nuclear Energy Agency meeting of the High-Level Group for Medical Radioisotope production. So it is recognized to be a concern 

throughout the industry for the long-term reliability of isotope supply of Mo-99 for the medical community, while at the same time 

we can achieve the nonproliferation objectives by using non-HEUbased production technologies. 

The CHAIRMAN. Mr. Brown, do you have a concern about this 

problem of the cost that U.S. companies would incur being undercut essentially by competition from overseas? 

Mr. BROWN. As I said in my testimony, we’re concerned that the 

waste takeback provision—that the cost we pay per cubic yard of 

waste to dispose of to DOE would be done at reasonable prices. We 

wouldn’t want to pay exorbitant prices that would throw the economics of any isotope production off. So what we’re asking for is 

a reasonable commercial rate for waste disposal. 

The CHAIRMAN. But you think with that, with a reasonable commercial rate for waste disposal, U.S. companies would be able to 

compete? 

Mr. BROWN. We feel we could, yes. 

The CHAIRMAN. All right. Let me ask one other question, Dr. Staples, about what actions the Department is working on to move the 

Russians to produce Molybdenum-99 with low-enriched uranium. 

Mr. STAPLES. Yes. Recently, there were several press releases 

that came out about a supply being developed in Russia that was 

utilizing highly enriched uranium for the production of Mo-99. We 

intend to raise this issue at very high levels in meetings with various Rosatom officials, such as Director Kiriyenko, to dissuade Russia from the use of HEU, to ensure that their actions are consistent 

with their Presidential-level commitments that they have made at 

the April 2010 Nuclear Security Summit to minimize and, where 

possible, eliminate the use of HEU in civilian activities. 

The CHAIRMAN. Let me ask you one other question, Mr. Brown. 

Does your council currently see supply meeting U.S. demand for 

Molybdenum-99 or do you expect additional shortfalls in the near 

future? 

Mr. BROWN. We are encouraged by some of the new efforts that 

are under way. We’re very encouraged by some of the development 

work, the cooperative grants that DOE has issued for some new development facilities. We do see some bumps in the road coming out 

in the future. We hope to have these new facilities up and running 

to minimize any impact of that. But we’re encouraged by the development work that’s going on now. 

The CHAIRMAN. You’re not alarmed by the prospect of shortfalls 

in the near future? 
12 

Mr. BROWN. There may be some shortfalls in the future, but 

we’re encouraged by the development activities that are under way 

to make up for those. 

The CHAIRMAN. All right. 

Senator MURKOWSKI. Just to follow onto that, given the legislation that we have in front of us, do you feel relatively comfortable 

that this will help us avoid those bumps in the road? Is this the 

level of assurance that you need if we can resolve the issue, for instance, with the takeback and some of the other issues you raised? 

Mr. BROWN. This legislation will be very helpful to assuring the 

long-term supply of medical isotopes in the U.S. It sends us well 

on our way to developing a domestic supply, too, with the development money put in there for DOE to issue additional development 

grants. 

The CHAIRMAN. Let me ask, what currently happens to the waste 

product from a highly enriched uranium target? Where is the disposal? Where is it? What does it look like? 

Mr. STAPLES. It’s stored, typically onsite at the four major global 

producers, in a variety of waste forms, under physical protection 

standards that meet IAEA protocol under 255 Rev. 4, which is the 

guidelines for physical protection for such nuclear materials. 

Senator MURKOWSKI. We had a discussion about the low enriched 

uranium. Is there more residual waste product from LEU as opposed to highly enriched uranium? 

Mr. STAPLES. In a simplistic conversion process from HEU to 

LEU where they would simply use a low enriched uranium target 

in place of a high enriched uranium target, yes, there would be additional waste that would be generated. 

Senator MURKOWSKI. That becomes a significant factor in terms 

of how we deal with the disposal and how we deal with the waste? 

Mr. STAPLES. Disposition of waste in the nuclear industry is always expensive and complicated. However, the isotope production 

industry actually is not significantly large, that it would be a reasonable and addressable amount of waste that would be produced, 

be it from HEU or LEU. We are developing in our program, options 

to minimize the amount of waste produced and in some cases—and 

this is what the National Academies study validated, that we do 

have some technologies available that could actually reduce the volumes of waste that are produced with LEU-based production. 

Senator MURKOWSKI. Given the current world production levels, 

how long does it take to accumulate enough of the radioactive 

waste product that’s left over to really pose a proliferation risk? 

Mr. STAPLES. Currently on a global basis approximately 40 to 50 

kilograms of highly enriched uranium is used by the total global 

community for isotope production, which according to the IAEA definition of a ‘‘significant quantity’’ is roughly two significant quantities of nuclear material per year that is being accumulated by the 

current global production using highly enriched uranium. 

Senator MURKOWSKI. The question has been raised by some in 

industry as to whether or not the legislation is technology-neutral. 

Can either one of you speak to that? 

Mr. STAPLES. Yes, I can address that first, and then if Mr. Brown 

would like to follow. That is part of the strategy behind developing 

multiple technologies to ensure that we do not have a single point 
13 

of failure. That is actually a common term of reference that we use, 

that we are technology-neutral with the neutron capture, the accelerator-based, and the solution reactor technologies not having any 

linkage to one of the other technologies, to ensure that we can be 

successful in implementation of the program. 

Senator MURKOWSKI. Mr. Brown, it’s technology-neutral in your 

opinion? 

Mr. BROWN. Yes. So far we’ve seen DOE give development grants 

or cooperative grants to several different types of technologies. So 

far their doling out of money has been very fair across the board. 

One thing we would like to see, we would like to avoid giving out, 

supporting many, many, many different efforts at one time, some 

of which may not bear any fruit. We would rather see a focus on 

just a few areas that look more promising. So far, DOE has been 

doing a good job, we feel, giving out the development grants. 

Senator MURKOWSKI. Here in the United States, where do we 

currently export our highly enriched uranium to for medical isotope 

production? 

Mr. STAPLES. Currently, we only export our HEU to Canada for 

the production of medical isotopes. 

Senator MURKOWSKI. Just to Canada then. Where do the other 

reactors that provide the U.S. with the Mo-99, where do they get 

their HEU? 

Mr. STAPLES. The European reactors use European-obligated material, which is inside the European Community’s control. Then 

South Africa utilizes indigenous material for their production of 

isotope, although as they transition to low-enriched uranium production they are receiving some low enriched uranium from the 

U.S. for this production process. 

Senator MURKOWSKI. Ms. Doane. 

STATEMENT OF MARGARET M. DOANE, DIRECTOR, OFFICE OF 

INTERNATIONAL PROGRAMS, NUCLEAR REGULATORY COMMISSION 

Ms. DOANE. We do provide—that’s with respect to targets, but for 

HEU fuel there are HEU exports to the European reactors, to The 

Netherlands, to Belgium. We have a current application pending 

for France. 

[The prepared statement of Ms. Doane follows:] 

PREPARED STATEMENT OF MARGARET M. DOANE, DIRECTOR, OFFICE OF

INTERNATIONAL PROGRAMS, NUCLEAR REGULATORY COMMISSION

Mr. Chairman and Members of the Committee on Energy and Natural Resources, 

thank you for inviting me to participate in this hearing today. As Director of the 

Nuclear Regulatory Commission’s (NRC) Office of International Programs, I am 

pleased to have this opportunity to discuss NRC’s licensing requirements for the exportation of highly enriched uranium (HEU) for the production of medical isotopes. 

My focus today will be on NRC’s regulatory framework for licensing the export of 

HEU. 

Framework for the Export of HEU 

I want to describe the NRC’s process in detail so that the Committee on Energy 

and Natural Resources has an understanding of the framework in which the export 

of HEU from the United States is taking place. The Atomic Energy Act of 1954, as 

amended, (AEA) grants the NRC exclusive jurisdiction to license civilian exports 

and imports of source, special nuclear, and byproduct materials to and from the 

United States. The NRC’s regulations governing such exports and imports are set 
14 

* Table has been retained in committee files. 

forth in Title 10 of the Code of Federal Regulations, Part 110, ‘‘Export and Import 

of Nuclear Equipment and Material.’’ 

Since 2005, the NRC has licensed seven exports of HEU to Canada and Belgium 

for fabrication of fuel or targets for the production of medical isotopes. The export 

licenses to Belgium authorized export of HEU for fabrication of fuel for reactors that 

produce, among other things, medical isotopes and the export licenses to Canada authorized HEU as targets or for the fabrication of targets that are used in the National Research Universal (NRU) reactor for the production of medical isotopes. Of 

the seven licenses issued since 2005, there is only one active license. Currently, 

there are two pending applications from Canada and France for the export of HEU. 

For additional information on HEU export licenses issued by the NRC since 1992, 

please see the attached table.* 

Prior to issuing a license for the export of HEU for the production of medical isotopes, the NRC works closely with the Executive Branch to ensure that the export 

is consistent with applicable U.S. non-proliferation laws and policies and is not otherwise inimical to the common defense and security of the United States. HEU may 

only be exported to countries that have in place an agreement for cooperation with 

the United States in accordance with section 123 of the AEA. These agreements set 

out the broad framework under which exports such as this may be authorized. 

Even when the United States has in place an agreement for cooperation with a 

country, the Commission must determine, on a case-by-case basis, whether an individual export to that country meets the applicable export licensing criteria in Sections 127 and 128 of the AEA, as codified in the Commission regulations at 10 CFR 

§ 110.42(a). Based on its evaluation, the NRC may impose additional requirements 

as conditions to the export license. 

Among other criteria, section 110.42(a)(3) requires the NRC to evaluate the adequacy of the physical protection measures in the country requesting the HEU. The 

physical protection guidelines are established by the International Atomic Energy 

Agency and are published in INFCIRC/225/Rev. 4, June 1999, ‘‘The Physical Protection of Nuclear Material and Nuclear Facilities.’’ The NRC participates in U.S. government physical protection bilateral visits to countries requesting HEU to confirm 

that the country’s implementation of physical protection methods and procedures for 

U.S.-origin HEU is consistent with these international guidelines. The delegations 

conducting the physical protection visits include staff from the NRC; National Nuclear Security Administration (NNSA); Department of Energy (DOE); Department 

of State; and Department of Defense. 

Any licensee authorized to export HEU is responsible for compliance with all applicable requirements of Title 10 of the Code of Federal Regulations, including 

NRC’s regulations related to transportation and packaging. Since 2005, all transportation of HEU has been conducted by DOE’s Office of Secure Transportation in accordance with the DOE requirements and directives. These measures meet and exceed NRC’s and Department of Transportation regulations in this area. 

For all HEU export license applications, the NRC would, as it did for each of the 

seven prior HEU applications, request the Executive Branch’s judgment on the proposed export, including whether the proposed export would be inimical to the common defense and security of the United States or otherwise significant for nuclear 

explosive purposes, and whether the export would comply with the terms of the applicable agreement for cooperation. In the seven prior cases, the Executive Branch 

determined that the export would not be inimical to the common defense and security, would take place pursuant to the applicable agreement for cooperation, and 

were consistent with the provisions of the AEA. 

In the Energy Policy Act of 1992, Congress amended the AEA to require the NRC 

to adopt additional, more stringent criteria specifically for licensing exports of HEU. 

These criteria were designed to discourage the use of HEU and encourage the development and use of low-enriched uranium alternatives. Under Section 134 of the 

AEA, the NRC may issue a license for the export of HEU to be used as a fuel or 

target in a nuclear research or test reactor only if, in addition to meeting the other 

AEA requirements for exports of special nuclear material, the NRC determines that: 

(1) There is no alternative nuclear reactor fuel or target enriched to a lesser 

percent than the proposed export that can be used in the foreign reactor; 

(2) The proposed recipient of the uranium has provided assurances that, 

whenever an alternative nuclear reactor fuel or target can be used in that reactor, it will use that alternative in lieu of HEU; and 

(3) The U.S. Government is actively developing an alternative nuclear reactor 

fuel or target that can be used in that reactor. 
15 

More recently, in the Energy Policy Act of 2005, Congress further amended the 

AEA by adding a new section 134b., ‘‘Medical Isotope Production,’’ in which Congress continued to encourage the eventual end of reliance on HEU targets in the 

production of medical radioisotopes. In the new AEA section 134b., Congress lifted 

certain restrictions on exports of HEU to Canada, France, Belgium, Germany, and 

The Netherlands for the production of medical radioisotopes if the recipient country 

supplies an assurance letter to the United States that the HEU will be used solely 

for medical isotope production, and if the NRC determines that the HEU will only 

be irradiated in a reactor that uses alternative fuel or is the subject of an agreement 

with the United States to convert to alternative fuel when such fuel can be used 

in the reactor. 

The NRC is mindful of the importance of the supply of medical isotopes for diagnostic and therapeutic medical procedures. Therefore, the NRC carries out this export licensing regime in an efficient and effective manner. Our regulations require 

notice of the application to the public and the opportunity to request a hearing on 

whether the export is consistent with our regulations. We also accept and review 

written comments even when a hearing is not requested. Once the various views 

are obtained, we then reach a carefully considered decision in accordance with nonproliferation policies, laws and regulations. 

Conclusion 

The NRC’s exclusive jurisdiction to authorize the export HEU for production of 

radio pharmaceuticals for diagnostic and therapeutic procedures is regulatory in nature and exercised only in accordance with the statutory framework and Congressional policies established in the Atomic Energy Act. In carrying out its regulatory 

responsibilities, the NRC works effectively with the Executive Branch, the recipient 

countries, the public, exporters and importers to assure the exports will not be inimical to the common defense and security and are consistent with policies to use alternatives to HEU when appropriate. 

Again, I appreciate the opportunity to participate today and look forward to answering any questions the Committee may have. 

Senator MURKOWSKI. Thank you, Mr. Chairman. 

The CHAIRMAN. Senator Manchin. 

Senator MANCHIN. Thank you, Mr. Chairman. 

First of all, let me just say that it’s a pleasure and an honor to 

be on the committee, and I appreciate it very much. It’s very meaningful for my State of West Virginia to be on the Energy Committee, and I’m sure we’re going to have some interesting times 

and I look forward to it. I truly believe that the security of the Nation depends on the independence that we have in our production 

of energy, from every State doing everything they can. 

So I look forward to working with you, Mr. Chairman and Senator Murkowski and the entire committee, for that. 

Sir, if I may, trying to get up to speed and being the new kid 

on the block, but learning a little bit about this, I would just simply 

ask, what are the implications if we don’t pass this legislation, if 

something for whatever reason—I know it got caught up in the 

111th Congress. I don’t think that’s going to happen, but if it would 

what would be the scenario for you? 

Mr. STAPLES. There are two implications that are really driven 

by this legislation. One is the nuclear security implications of how 

we as a government are trying to address HEU minimization for 

threat reduction. That’s actually—our commitment is consistent 

with the pledge that was made by the leaders at the Nuclear Security Summit in April 2010. 

Further implications are for the reliable supply of medical isotopes to the U.S. community. There are indications that the Canadian reactor, the NRU, where they currently produce Mol-99, the 

bulk of which is used here in the United States, will cease operations in the 2016 timeframe. At that point, our supply of medical 
16 

isotopes is at serious risk for providing the various procedures that 

Mr. Brown alluded to recently, which is primarily the diagnosis of 

heart disease and then various other operations or activities that 

are performed. 

Senator MANCHIN. You had—in 2009 the National Academy of 

Science reported it found that the use of highly enriched uranium 

in the production of medical isotopes could be phased out and replaced by low enriched uranium by the 2016 to 2020 timetable. You 

don’t think that can be met? 

Mr. STAPLES. No, we do believe that we can address that concern. I have a significant amount of confidence in the activities that 

we are putting in place to develop these cooperative agreements 

with our commercial partners for reliable isotope supply, and we 

also have a significant amount of confidence to be able to transition 

the international producers to an LEU-based Mo-99. 

Senator MANCHIN. So the elimination from Canada will not cause 

a problem in the United States? 

Mr. STAPLES. If we are successful with developing our domestic 

cooperative agreements, that will be the replacement production 

capacity that the global medical community would require to maintain providing their services. 

Senator MANCHIN. What are the potential consequences to any of 

you there if it falls into the wrong hands, as far as our production? 

Mr. STAPLES. I believe that you’re referring to the use of the 

highly enriched uranium? 

Senator MANCHIN. Yes, correct. 

Mr. STAPLES. Highly enriched uranium can be used by either terrorists or rogue states to construct an improvised nuclear device. 

Senator MANCHIN. Has there been any breach of that at all or 

any indication that that might be what they’re trying to acquire, 

or do we have security checks in place to take care of that? 

Mr. STAPLES. I probably would like to take that question for the 

record and get back to you, just to make sure that I am properly 

attributing all of the events that might or might not have taken 

place. 

[The information referred to follows:] 

From the NNSA perspective, we are unaware of any indication of diversions of 

HEU from the Mo-99 production process. 

Senator MANCHIN. So we don’t have any reported incidents 

where that’s been breached? 

Mr. STAPLES. I am not positive of any definite activity that has 

taken place related to Mo-99 isotope production and highly enriched uranium. 

Senator MANCHIN. Thank you. 

The CHAIRMAN. Senator Burr. 

Senator BURR. Thank you, Mr. Chairman, and I thank you and 

Senator Murkowski for calling this hearing and for introducing the 

legislation. 

I think over the last several years, Mr. Brown, we have had a 

supply interruption affecting not just cancer patients, but all patients. I want to sort of go where Senator Manchin was and let you 

sort of take that and run. 

Dr. Staples’ comment alarmed me greatly. He said: If we are successful. OK, let’s approach it from another angle. If we’re not suc-
17 

cessful, if the legislation is delayed, if we don’t get the robust participation, if we can’t find the private sector agreements, if the 

NRC doesn’t license, and if production doesn’t run on time, what 

happens to patients? I don’t think they’re sending us signs. Canada’s going to shut down in 2016. 

Mr. BROWN. It’s clear, coming from Canada, they do plan on, 

from what we understand, re-licensing the NRU in 2011 for another 5 years, which will terminate in 2016. So that’s pretty clear. 

We are very encouraged by the development activities that are 

under way now. There are several different private concerns looking at new technologies and new methodologies, new production facilities for Mo-99. So we’re very encouraged by that. 

This legislation is very important because it helps us develop a 

domestic supply of Mo-99. 

Senator BURR. But if we don’t have Mo-99, if we have an undersupply or no supply, what does that do to patient care? 

Senator BURR. It’s used in 18 million procedures a year in the 

U.S. Every year, 18 million procedures. We did see shortages, as 

you know, in 2010 and it was impacted. Some hospitals were impacted by the shortage of Mo-99 and Technetium-99, so it did have 

an impact. Other technologies were employed. Other isotopes were 

used, for example Thalium-201 for stress tests, for heart imaging. 

Thalium-201 was used instead of Technetium-99m. In some cases 

Fluorine-18 was used instead of Technetium-99m. In some cases 

other technologies, ultrasound, was used. Echo cardiography was 

used in place of Technetium. So there are other technologies. 

Senator BURR. If all those techniques, if all those tools were as 

good as Mo-99, we’d use them today. 

Mr. BROWN. You’re right. It’s clear that Technetium-99m is the 

preferred method. It collects more diagnostic information. It’s better quality information and it’s cheaper. 

Senator BURR. Over the long run it costs less in the health care 

system. So we’re talking about health care cost reduction. 

Mr. BROWN. You’re absolutely right. 

Senator BURR. Let me ask you. You talked about the waste 

stream. What is a reasonable price? 

Mr. BROWN. I don’t have that number off the top of my head. We 

can get back to you on that. What we’re looking for is just we don’t 

want to pay an exorbitant amount that would throw the economics 

of any new production facility off. We can get together with an answer on that. 

Senator BURR. Let me suggest to you that that’s an important 

number to know, and it goes to the heart of what you said, Dr. Staples, that there has been talk, if I understood you correctly, that 

everybody globally would be guaranteed cost recovery, that all producers would be guaranteed cost recovery. How do we calculate 

what that is? 

Mr. STAPLES. In operating in the commercial industry, the issue 

now is that governments are providing various subsidies for their 

operations. Either the facilities are using facilities that were initiated through government construction and then they have transferred over to commercial activity, so they’re fully amortized in 

terms of government funds rather than through the commercial ac-
18 

tivities; or waste disposition is provided for some of the activities 

that take place with the commercial producers. 

What we are discussing at the OECD meetings and the Nuclear 

Energy Agency is how to implement a full cost recovery for all of 

the commercial activities that are undertaken in this industry to 

ensure that they can develop and maintain their production as they 

would move into the future and that there is no—that there is no 

oversupply generated in the market, either, from any one entity 

that might be heavily subsidized and be able to prevent the introduction of another commercial activity from another country. 

Senator BURR. Two things. In the past the Department of Energy 

has asked companies to commit to facilities that can provide approximately 50 percent of the U.S. market demand for medical isotopes. I would suggest to you this could lead to a substantial oversupply in the market if all current suppliers provided 50 percent 

of the market. 

I guess I would ask, if we changed that word to ‘‘significant’’ 

versus ‘‘50 percent’’ would that be sufficient and would it eliminate 

the risk of oversupply? 

Mr. STAPLES. It could eliminate the risk of oversupply. That’s a 

very important point that you’re making. As I stated before in the 

response with the likelihood of the Canadian reactor ceasing production in 2016, it’s the importance that what we are developing 

in the United States would be replacement production capacity to 

complement the other production that takes place in the international market. 

There are significant dynamic forces at play in the global isotope 

production community and this is what we are trying to coordinate 

when we work with OECD to ensure that we can have reliable replacement supply. A significant amount of overcapacity is also required because of the manner in which the isotope is produced in 

reactors which regularly go through maintenance shutdowns and 

other periods, to ensure that, while we can maintain a minimum 

level, the overcapacity does need to be maintained within the industry to ensure that we always have the supply for the medical 

community. 

Senator BURR. Let me just raise for my colleagues this personal 

observation. When I see a marketplace that is going to be coordinated on reimbursement, government influence from the standpoint of cost calculations, I begin to see a marketplace that doesn’t 

attract private dollars. I think what we’re trying to set up in the 

United States is the injection of private capital to do this, though 

with the incentive of grants from the U.S. Government. 

So let me just say, we ought to be particularly careful that the 

net result of this is that we don’t create something globally that is 

dominated by government, that takes the health care cost advantages that we have today and raises the cost precipitously to where 

new technologies for the delivery of care are not developed. I think 

at the same time you have to consider that 10 years ago we didn’t 

use as many procedures, didn’t use this. 10 years from now there 

may be many more procedures that utilize this. The supply needs 

may be much greater. 

Mr. Chairman, could I ask one question of Ms. ‘‘DOWN’’? 

Ms. DOANE. Yes, ‘‘DOANE.’’ 
19 

Senator BURR. ‘‘DOANE.’’ 

I guess my question is this. What’s a reasonable timeframe for 

licensing and production, because the NRC is going to have to license, right? 

Ms. DOANE. Yes. I think we’ve answered—when we answer these 

questions, typically we say: Of course, it depends on the application. 

Senator BURR. No, but let me just state this. There is the health 

of the American people at play here. So going into this we’ve got 

to have some certainty as to what the time line is for licensing. 

Then I’ll turn to Mr. Brown as an industry person later on and 

say: Can you make the production capabilities? But if the NRC 

delays licensing, it doesn’t matter how good we do from the standpoint of the NNSA or from DOE or from the industry; this isn’t 

going to happen. We’re going to have a gap. 

Ms. DOANE. No, understandably. I think that we do understand 

the importance of licensing these production facilities and we have 

started pre-licensing review. I can’t today give you an exact timeframe because the concepts are not completely developed yet. 

Senator BURR. There are no applications yet. 

Ms. DOANE. There are no applications. But I can tell you that we 

are taking it seriously. We’re doing a lot of pre-application work 

and trying to establish processes that—we have processes in place, 

but actually standards and procedures that will help the proceedings run more smoothly. 

Senator BURR. What prescriptive legislation—what prescriptive 

language needs to be in this legislation to encourage the NRC to 

license new technologies that may be on the horizon that may not 

be the standard generation of LEUs today that NRC might be familiar with? 

Ms. DOANE. It would be my opinion we don’t need new legislation 

because our legislation—we have broad discretion to license new 

technologies. You can imagine with new reactors, for example, 

we’re doing all kinds of new types of technology. I think we do 

have—I can take this back and ask the lawyers, but I think for 

now we have broad discretion and it’s just a matter of setting up 

the guidelines and the procedures as we get the applications in. 

Senator BURR. The chairman’s been awfully lenient with me and 

the only thing that I would say in concluding is that on the electric 

generation side there has been technology breakthroughs on smaller, compact nuclear generation units that have not been received 

warmly at the NRC because they’re new. Now, I’m not going to tell 

you that there are applications that are out there, but there are 

technologies that are advancing and certainly things that show 

promise. Yet from a regulatory standpoint they don’t seem to be 

moving with the progress that one would like. 

I only hope that that’s not the case with new technologies as it 

relates to the LEU market and the production that we need. 

Mr. Chairman, I thank you. 

The CHAIRMAN. I would just make the point, I think I’m right 

that there are no applications for these small modular nuclear reactors, either. 

Ms. DOANE. No. But we are doing, again, a lot of prelicensing 

work to make that run efficiently when we do. 
20 

The CHAIRMAN. Senator Franken. 

Senator FRANKEN. Thank you, Mr. Chairman, and thank you, 

Senator Murkowski, the ranking member, for welcoming me earlier. 

I apologize; I’m kind of jumping between this and the Judiciary 

Committee hearing. I did read your testimonies last night, but I 

did miss your oral testimonies today. So forgive me if I ask a question that you’ve already covered. 

I just want to say what an honor it is to be on this committee. 

It’s so clear that energy is central to so many critical issues, the 

economy, our national security, the future of the planet, just those 

things. 

This is a question for pretty much any of you, probably—for any 

of you: What is the global buy-in on going to low enriched uranium 

to make Mo-99, as opposed to highly enriched uranium? In other 

words, are the other nations that produce this, are they also going 

to be going to low enriched uranium? 

Mr. STAPLES. I can follow on. That again refers back to the discussions we just had last week at the OECD conference on medical 

isotope production. We also do discuss the issue of conversion of 

their facilities to low enriched uranium. As I mentioned, the South 

Africans have already begun converting their process over to LEU 

and in December provided the first LEU shipment for commercial 

distribution here to the United States. 

We are in discussions both with the Dutch and the Belgians 

about converting their processes. They have made statements that 

they are working in that direction. However, they do want to be assured that while they work toward conversion toward LEU that 

they don’t impinge upon their ability to supply isotopes to the market today, because their production facilities have limited resources 

and they need to carefully manage how we work the conversion 

program at their facilities while they maintain the production capacity that’s required for the medical community. 

Senator FRANKEN. Mr. Brown, you just nodded. 

Mr. BROWN. I would have to agree. I think there is general concurrence of the need to move from HEU to LEU. CORAR is certainly supportive of that, the philosophy in that bill, in the bill 

here. 

Senator FRANKEN. Let me ask you then about Iran, because Iran 

is our probably biggest proliferation concern. In 2009 we came close 

to a confidence-building deal with Iran. Iran would ship its low enriched uranium out of the country; in return it would receive the 

fuel it needed for a research reactor that produces medical isotopes. 

But Iran backed out of the deal and now it’s claiming that it needs 

more highly—to enrich more uranium to be highly enriched uranium for the purpose of producing medical isotopes. 

So my question is, if we move toward eliminating the use of highly enriched uranium in the production of medical isotopes, would 

that help to undercut the argument that Iran has and potentially 

other proliferators might make, that it needs to enrich its low enriched uranium more highly for medical purposes? 

Mr. STAPLES. Let me respond to that. I would say yes. Our efforts, in addition to the 2009 National Academies study, Mo-99 production efforts by countries such as South Africa, Australia, and 
21 

Argentina, and a recent IAEA-coordinated research project for indigenous production of Mo-99 without the use of HEU have all 

demonstrated that highly enriched uranium is not needed for medical isotope production. 

In fact, there’s really no economic justification and very little 

technical justification for every country to produce its own enriched 

uranium for medical isotope production. The international commercial supply of LEU for medical isotope production is more than sufficient to meet the needs of the global medical community. 

So the global shortage that we face is primarily due to the limited large-scale processing facilities to take the irradiated targets 

and turn them into the medical commodity that’s used by the community. 

Senator FRANKEN. So presumably we could—I mean, our arguments with Iran don’t necessarily prevail, but we can make the argument to them that they don’t need highly enriched uranium to 

make these medical isotopes? 

Mr. STAPLES. That is correct. 

Senator FRANKEN. OK. Since my time is up, thank you. 

The CHAIRMAN. If you have any other questions, go right ahead. 

Nobody here but us chickens. We’re about to finish the hearing, so 

go ahead. 

Senator FRANKEN. I’ve got some chickens over at the Judiciary 

that I’ve got to go see. 

The CHAIRMAN. All right. Thank you very much. Thanks for your 

very good questions. 

Senator Murkowski, did you have additional questions? 

Senator MURKOWSKI. Just a couple quick ones. 

Mr. Brown, you mentioned the issue of NEPA review and further 

environmental analysis being something that could potentially 

delay the process. In addition to Senator Burr’s good questions 

about the regulatory process, I think we recognize when we talk 

about bumps in the road or things that could be a problem, certainly I think when you interject the unknown morass of regulation 

or something like NEPA which is difficult to project. 

Dr. Staples, please provide your comments about the potential 

for delay with additional environmental assessment? 

Mr. STAPLES. We have been evaluating that process significantly 

to make sure that we can be successful with our technology-neutral 

activities. In some cases we do require significant NRC licensing 

approval for operation. Some of the other technologies have different NRC licensing requirements, such as the accelerator-based 

technology, which is essentially non-nuclear and utilizes no uranium for the production of medical isotopes. 

But regarding the NEPA, we have been in close contact with the 

Nuclear Regulatory Commission also, to coordinate our NEPA approaches to ensure that we do not have any duplicate processes 

and that we meet our NEPA obligations as a government and that 

we do this in the most efficient manner so that we can ensure the 

accelerated production of Mo-99 for the United States. 

Senator MURKOWSKI. You don’t view a NEPA review as being duplicative of the other reviews that are currently in place? 
22 

Mr. STAPLES. We need to fulfill that obligation and we are working closely to coordinate our efforts with the NRC to accomplish 

that. 

Senator MURKOWSKI. Is there something that we should or 

should not include in this legislation that would speak to that as 

an issue? 

Mr. STAPLES. I would actually like to take that as a question for 

the record, because we have put considerable thought into that and 

I don’t think I could do full justice to the response here on the 

floor. 

The information referred to follows:] 

To ensure that NNSA’s effort is in compliance with the National Environmental 

Policy Act (NEPA), GTRI is currently proceeding through the required NEPA approval process within the U.S. Department of Energy. The Nuclear Regulatory Commission (NRC) has NEPA requirements for the licensing process, and GTRI has 

been coordinating with the NRC in order to avoid any duplication of nEPA analysis 

efforts. We have recognized the potential for this risk to the schedule of the domestic production projects and are working to implement the required procedures while 

maintaining our accelerated schedule to produce Mo-99 for the U.S. medical community. 

After a preliminary technical review of the various candidate technologies to enable the domestic production of Mo-99 within FY10-FY14, important schedule risks 

and mitigation strategies have been identified. Among the most important of the 

schedule risks is the obligation to prepare analyses to fulfill the Department’s NEPA 

obligations. In order to mitigate the schedule risk NEPA requirements pose to 

achieving domestic production within the timeframe of this legislation, high-level 

political support to expedite all NEPA analyses is necessary. 

Senator MURKOWSKI. I would appreciate that. 

Let me ask a question just in terms of deliverability and how we 

move things, recognizing that it has a pretty short lifespan or shelf 

life, as it relates to the medical isotopes. What happens when you 

have an incident like we had in Europe with the eruption of the 

volcano that shut down air traffic for days, a week in certain areas? 

We talk about putting a process in place that is going to make 

sure that we have a good supply. But if we can’t stockpile, how do 

we respond to disruptions like we’ve seen? 

Mr. STAPLES. That speaks perfectly to the point of developing a 

diverse, reliable supply with very few single points of failure and 

trying to disseminate the production globally to ensure that any 

one regional event does not impact the global medical community. 

Senator MURKOWSKI. But right now, because you have so much 

production centered in Europe, you have a stumbling block if something happens. 

Mr. STAPLES. Yes. During the volcanic eruptions I do have the 

impression and understanding that we were impacted in terms of 

our supply of isotope for some periods of time. 

Senator MURKOWSKI. The U.S. was? 

Mr. STAPLES. Yes. 

Senator MURKOWSKI. I would assume—— 

Mr. STAPLES. Europe. 

Senator MURKOWSKI. Europe and beyond; would it not be? 

Mr. STAPLES. Yes. 

Senator MURKOWSKI. So at this point in time, we don’t have an 

answer in place as to how to respond. 

Mr. STAPLES. No. That’s actually why your committee’s support 

for this legislation is very important. We’ve mentioned last week at 
23 

the OECD meeting not to become complacent as a community as 

we try to address that. Your continued support with this legislation 

will give us the motivation and the impetus to work with the commercial industry to ensure that we develop solutions as best as possible for the isotope supply. 

Senator MURKOWSKI. Mr. Brown. 

Mr. BROWN. This legislation also encourages developing of a domestic supply here in the U.S., where if there is another volcano 

we don’t have to worry about flying planes from Europe to the U.S. 

If we’re producing it here locally and have a domestic supply, obviously volcanoes in Iceland wouldn’t be a problem. So that’s why 

we’re encouraged by this legislation. We think it would help encourage domestic supply. 

Senator MURKOWSKI. Thank you, Mr. Chairman. 

The CHAIRMAN. Thank you very much. 

I didn’t have any additional questions. Senator Manchin, did you 

have additional questions? 

Senator MANCHIN. I just want to thank you all so much, and the 

concern that you have and bringing it to our attention. I want to 

thank the chairman and Senator Murkowski for being so diligent 

on this issue, and I hope to see that we move quickly on it. 

The CHAIRMAN. I think that sums up my views as well. I hope 

we are able to move quickly on this legislation. Again, I thank all 

three of you for being here to give us your views, and we will conclude the hearing. 

[Whereupon, at 10:54 a.m., the hearing was adjourned.] 

(25) 

APPENDIXES 

APPENDIX I 

Responses to Additional Questions 

RESPONSES OF ROY W. BROWN TO QUESTIONS FROM SENATOR BINGAMAN

Question 1. Can you please explain in more detail how CORAR would determine 

what it means by a reasonable fee for the fuel take provision in this legislation? 

Answer. A contract with DOE to accept the High Level Waste produced as a result of Mo-99 and other medical isotope production is critical. Under S. 99 the uranium would be leased from DOE and taken back. The legislation doesn’t appear to 

determine whether the waste taken back is a commodity or a waste when received 

by DOE. How DOE categorizes the ‘‘waste’’ is not that important, unless it makes 

a difference in the ‘‘reasonable fee’’. While industry expects to pay for the waste disposal, we also cannot afford a heavy burden in the form of fees to take back the 

waste. A DOE program similar to what they do for research reactors might be a 

model—assuming the cost of providing and taking back uranium is reasonable. A 

High Level Waste fund, similar to what commercial power reactors have with their 

standard contracts, would be unworkable. CORAR recommends DOE charges a fee 

for this waste disposal that would be comparable to what commercial fees would be, 

if commercial waste disposal for this type of waste were available. 

Question 2. Do you see Positron Emission Tomography as a cost effective replacement to Molybdenum-99? 

Answer. Positron Emission Tomography (PET) is an emerging technology that 

provides a complementary option for imaging certain types of tumors and staging 

cancer. It currently provide approximately 2 million imaging procedures each year 

in the U.S. compared to approximately 17 million using Tc-99m from Mo-99. It is 

more expensive than comparable Tc-99m studies, even though the cost for PET 

scans has steadily decreased over the last ten years. PET currently accounts for a 

small amount of myocardial perfusion imaging studies (including through use of rubidium-82 generators). F-18 based PET (half life of 110 minutes, as opposed to 70 

seconds for rubidium-82) for myocardial perfusion imaging will not become commercially available for at least a few more years. PET is currently more expensive than 

SPECT, but given the higher quality images, increased diagnostic certainty and potential for blood flow quantification with PET, even at a higher per procedure price, 

F-18 based PET could rapidly become a cost effective alternative to SPECT in a 

number of different contexts. Currently, PET is viewed to be complementary rather 

than a replacement for Tc-99m. 

Question 3. In CORAR’s opinion what technology do you see as the quickest to 

market for domestically producing Molybdenum-99? 

Answer. There are several new technologies being examined for the production of 

Mo-99. The traditional methodology entails fissioning U-235 with neutrons for the 

production of Mo-99 and other medical isotopes. Other technologies being examined 

include neutron capture using Mo-98, accelerator production of Mo-99 using Mo-100 

targets, and production of Tc-99m using a proton beam from an accelerator onto a 

Mo-100 target. The use of aqueous homogenous reactors, which have cost and waste 

reduction attributes, is also being developed. Many of these new technologies are 

being developed simultaneously. It is not clear yet which of these new technologies 

will lead to the most efficient production of Mo-99 with the shortest development 

time. For that reason CORAR feels it is important to promote all credible technologies on parallel paths and allow the most efficient method to emerge. 

Question 4. How large a market do you see Russia providing for Molybdenum— 

99 from Highly Enriched Uranium? 
26 

Answer. The current supply chain of Mo-99 coming from Russia is the production 

at the Research Institute of Atomic Reactors in Dimitrovgrad. Initial quantities 

through the Nordion supply chain are expected to be incremental. Over several 

years, the expectation is to have supply available from the Russian Federation of 

up to 20% of global Mo-99 demand to back up Nordion’s long-term requirements. 

The evaluation process, for samples of Mo-99 from the Russian Federation, has been 

initiated through the Nordion Canada facility. Nordion continues to work with the 

Russian Federation to bring this commercial back-up supply of Mo-99 on-line. Specific details of the supply agreement are confidential. 

The Russian supply agreement provides for the parties to address LEU conversion 

of the Isotope Mo-99 productions facilities. The timing and approach of conversion 

are currently under discussion for finalization. 

Following a meeting of the Nuclear Energy and Nuclear Security Working Group 

of the bilateral Russian-US Presidential Commission in Moscow on December 7th, 

2010, an agreement was signed between Russian state nuclear energy company 

Rosatom and the DOE. The two organizations will initially consider the possibility 

of converting six Russian research reactors from HEU to LEU fuel. 

Nordion has also recently entered into a Framework Agreement with the 

Kurchatov Institute in the Russian Federation to collaborate in the development of 

medical isotope production capabilities using Liquid Homogenous Reactor technology, utilizing LEU-based production. This initiative is aimed at providing additional LEUbased Mo-99 production capacity from the Russian Federation. 

At the Kurchatov Institute in Moscow, the Argus reactor was originally commissioned in 1981 and is currently the only stationary LHR (Liquid Homogeneous Reactor) left in operation in the world. Conversion of the Argus reactor to LEU has been 

recently approved by Russian Government as a result of the recent agreement 

signed by Russia with US DOE. 

At present a conceptual modular production system with a capacity of 5-10% of 

the global Mo-99 demand is being considered. Multiple units could ultimately deployed using this technology depending on Markey dynamics. The timeframe to 

achieve commercial production of Mo-99 using this technology is currently being assessed and is expected to be 3-5 years. 

RESPONSES OF PARRISH STAPLES TO QUESTIONS FROM SENATOR BINGAMAN

Question 1. Can you please explain the contract you have undertaken with South 

Africa to produce Molybdenum-99 (Mo-99) from LEU, specifically technology used, 

the amount and duration? 

Answer. The National Nuclear Security Administration’s Global Threat Reduction 

Initiative’s (NNSA-GTRI) Mo-99 program has two separate missions: (1) highly enriched uranium (HEU) minimization through conversion of existing facilities and (2) 

support for accelerating existing commercial projects in the United States in the 

production of a domestic, non-HEU-based supply of Mo-99. GTRI entered into a contract with the South African Nuclear Energy Corporation (Necsa), and its subsidiary 

NTP Radioisotopes, in order to accelerate the conversion of their existing production 

capability from the use of HEU targets to low enriched uranium (LEU) targets. The 

technology utilized in the conversion process was developed and implemented by 

Necsa/NTP and is proprietary. The contract with Necsa is worth up to US$25M and 

is designed to accelerate the implementation of their technology and to complete the 

conversion of the facility by the end of 2013. As this contract falls under GTRI’s 

HEU minimization mission, it is intended to support Necsa in maintaining its current production capability as it transitions to LEU-based production. GTRI’s support 

to South Africa is not intended to augment South Africa’s ability to produce additional amounts of Mo-99 for the global market. 

Question 2. Were you able to convince any U.S. reactor operators to use the LEU 

technology developed by the NNSA before contracting with South Africa? 

Answer. Removing the HEU from South Africa is a high non-proliferation priority, 

as HEU could be used to make a nuclear weapon if it fell into the wrong hands. 

NNSA is cooperating with the South Africans to remove the HEU while demonstrating that the reactor can still be used for isotope production. NNSA’s efforts 

in the United States are quite different, as we are working to establish, rather than 

convert, Mo-99 production facilities. There has been no domestic production of Mo99 since Cintichem’s 1990 decision to decommission the Tuxedo reactor located in 

Tuxedo, New York. 

The decision for the specific technologies being developed for the conversion of existing international Mo-99 producers to LEU, or for development in the United 

States, is driven by the producers themselves. NNSA’s LEU target technology is one 
27 

of many possible technologies these producers may have used. The technology utilized in the conversion process in South Africa was developed by and is unique to 

Necsa/NTP and is proprietary. The contract between NNSA-GTRI and Necsa is designed to accelerate the implementation of Necsa’s technology and to complete the 

conversion of the Necsa facility by the end of 2013. 

Each of the U.S. domestic projects uses a technology selected and implemented 

by the potential producer. As these are independent, commercial projects, GTRI is 

only providing support to accelerate their timeline to help ensure that the United 

States and its medical community have access to a reliable domestic supply of Mo99 as soon as possible. The technology developed by NNSA and Argonne National 

Laboratory is publicly available and was an option under the recently issued Funding Opportunity Announcement. However, none of the proposals submitted from the 

domestic commercial entities utilized this specific technology. 

RESPONSES OF PARRISH STAPLES TO QUESTIONS FROM SENATOR CANTWELL

Question 3. Washington State University (WSU) in my state has a research reactor that has been fully converted to low enriched uranium (LEU) fuel, and is capable 

of supplying a significant portion of U.S. demand for molybdenum-99 and other 

medical isotopes. I commend the Department of Energy and the National Nuclear 

Security Administration for their efforts to establish grant programs to accelerate 

the development of a medical isotope industry that does not use highly enriched 

uranium (HEU). What is the current status of awarding grants for such projects? 

Answer. NNSA issued a Funding Opportunity Announcement (FOA) for LEU target technology and accelerator technology on March 26, 2010, which resulted in the 

selection of two cooperative agreement partners to demonstrate the accelerator technology. 

In general, large-scale quantities of LEU-target-based Mo-99 production require 

a research reactor that operates steady-state, has a short operating cycle, can dedicate operating time to Mo-99 production, and runs with sufficient power and neutron flux to produce Mo-99. There are few facilities in the United States that meet 

these requirements. While there are some research reactors in the United States 

that could irradiate LEU targets, a processing facility with dedicated hot-cells, optimally co-located with the reactor, and with a staff experienced in isotope production 

using FDA good manufacturing practice are also necessary for producing Mo-99. The 

United States does not currently have hot-cells that are dedicated to this purpose, 

and the LEU-target technology project will likely require the construction of a new, 

co-located processing facility. 

Question 4. What is involved in converting a reactor from HEU to LEU fuel? What 

is the typical timeline for such a conversion? What kinds of technological risks affect 

this timeline? How much reactor and/or Mo-99 production downtime would be required to make this conversion? 

Answer. The process to convert a reactor from HEU to LEU fuel follows a few 

generalized steps. First, feasibility models are calculated to demonstrate the viability of conversion, and to verify that commercially available fuel can be used safely 

in the reactor without disruption to the basic parameters required to achieve the 

facility’s mission. Next, a detailed analysis and safety report is prepared in order 

to obtain regulatory approval. Finally, new LEU fuel is manufactured for the reactor 

for LEU-based operation upon its licensing conditions. The typical timeline for this 

process varies widely, but is generally not less than two years and in some cases 

can take as long as five years depending on resource availability. 

Additionally, some high performance reactors cannot be converted with existing 

qualified LEU fuels and require a new high-density LEU fuel, which NNSA is in 

the process of developing. 

Typically, the actual conversion process involving the insertion of LEU fuel is accomplished during a normal shutdown period for maintenance or during refueling 

operations. In either case, the physical process rarely takes longer than one month. 

The conversion process above describes the conversion of the reactor fuel from 

HEU to LEU. In addition to converting the reactor fuel, the targets used to produce 

Mo-99 also require conversion to LEU. By converting both the reactor fuel and Mo99 targets, the use of HEU in civilian applications is significantly minimized worldwide. 

Question 5. In your opinion, would it be preferable to produce medical isotopes 

from an existing LEU-fueled source rather than an HEU-fueled source that would 

need to be converted at a later date? 

Answer. Although LEU-fueled reactors are preferable from the perspective of nonproliferation, the decision of whether an HEU or LEU fueled facility would be considered preferable for isotope production is not determined by the level of enrich-
28 

ment of the fuel. For example, the specific design and size of the facility for isotope 

production, as well as other R&D projects, are more important for medical isotope 

production than the fuel enrichment. Isotope production is better suited to a facility 

specifically designed for large scale production, not necessarily whether the facility 

operates on an HEU or LEU-based fuel. 

That said, all of NNSA’s Cooperative Agreement partners use technologies consistent with U.S. nonproliferation objectives, in that they do not utilize HEU in the 

production process. 

Question 6. Please give a brief overview of the technology options available for 

producing medical isotopes without HEU, and the current status of each from a 

technical and commercial feasibility standpoint. 

Answer. The basic strategy of NNSA’s Mo-99 program is to accelerate the commercial establishment of a diverse and reliable domestic supply to avoid any single 

point of failure. NNSA is supporting three separate non-HEU-based technology 

pathways: solution reactor, neutron capture, and accelerator. The fourth technology 

described in this section, LEU target, is an available technology option, but one that 

ultimately was not pursued under the FOA. The goal of the program is to support 

the establishment of domestic commercial production as rapidly as possible where 

economic forces will dictate the future market for medical isotopes. 

The following technology options are alternatives to produce medical isotopes 

without the use of HEU. 

1. Solution Reactor Technology—Solution reactor technology has been demonstrated and there is experience in operating homogeneous solution reactors. 

Production rates for this technology are expected to be among the highest of the 

different technologies being considered, although additional R&D on fuel solution chemistry during operation and the recovery of Mo-99 from the irradiated 

fuel solution is required. This production process generates radioactive waste, 

although total amounts are less than those generated by the standard fissiontarget technology. 

2. Neutron Capture Technology—This process is based on neutron capture in 

targets of Mo-98. This is a well known technology and is historically how Mo99 was supplied to the medical community when the industry was first being 

developed. It is based on utilizing Mo-98 targets and a source of neutrons, 

which are captured in the target resulting in the production of Mo-99. As with 

the accelerator-based technologies, this technology has the benefit of resulting 

in a minimal amount of radioactive waste, compared to the standard fission-target technology, although it has a lower specific activity than fission-based Mo99 processes. Since current generators in the nuclear pharmacies cannot use the 

Mo-99 generated from this process, another design would need to be developed. 

3. Accelerator Technologies—The first proposed accelerator technology is 

based on exposing Mo-100 targets to high energy gamma rays to induce a reaction that produces Mo-99. The major components of this option are based on 

proven technologies. Once the technology is demonstrated in a complete process, 

it offers the possibility of relatively simple operation from the standpoints both 

of the accelerator and the target processing facility, because of the reduced radioactive environment in the absence of fission products. This non-fission based 

technology has the benefits of resulting in minimal radioactive waste compared 

to the standard fission-target technology. R&D is needed for the Mo-100 target 

designs and for the overall proof of concept. The lower specific activity of the 

Mo-99 (compared to fission-based processes) resulting from this process prevents 

current generators from being suitable for use, requiring the development of another generator design. 

The second proposed accelerator technology is based on fissioning an LEU 

aqueous target through the introduction of accelerator-produced neutrons. Since 

the technology fits into the existing supply chain, where Mo-99 is extracted 

from uranium fission products before it is purified, there may be a lowered cost 

of production. R&D is currently underway to prove the concept and scale up the 

concept for major production. 

4. LEU Target Technology—The irradiation of solid uranium targets with a 

neutron source to produce Mo-99 is a demonstrated technology currently used 

by the industry (most current production is done with HEU targets). The overall 

process (target preparation, irradiation, and dissolution) using LEU targets is 

nearly identical to that of using HEU targets and may therefore offer an easier 

transition for HEU-based producers. Production rates for a LEU target facility 

are expected to be among the highest of the different non-HEU technologies 

being considered. Development of the processing facilities to dissolve the targets 

and extract Mo-99 needs to take place to support eventual production; however, 
29 

some LEU production facilities are already in existence, such as in Australia, 

Argentina and others, as listed in the 2009 National Academies report ‘‘Medical 

Isotope Production without Highly Enriched Uranium.’’ In addition, fissionbased technology can use existing Tc-99m generators, which will expedite the 

delivery of Mo-99 to the market. However, among the technologies considered, 

fission-based production generates the most radioactive waste. 

NNSA is not providing support for this technology as the company selected 

for demonstration of the LEU target technology ultimately declined the FOA 

award. 

The Organization for Economic Cooperation and Development’s Nuclear Energy Agency (OECD-NEA) published a report, ‘‘The Supply of Medical 

Radioisotopes: Review of Potential Molybdenum-99/Technetium-99m Production 

Technologies,’’ that describes both these and additional technical pathways to 

producing Mo-99. It can be found on the OECD’s website at: http://www.oecdnea.org/med-radio/reports/Med-Radio-99Mo-Prod-Tech.pdf. This report is currently the most conclusive study on the potential technologies for producing Mo99, and was produced in response to a request by the OECD-NEA’s High-Level 

Group on the Security of Supply of Medical Radioisotopes (HLG-MR), of which 

Dr. Parrish Staples is one of two U.S. government representatives. 

Æ