89–010 

Calendar No. 263 

111TH CONGRESS REPORT " ! SENATE 2d Session 111–120 

AMERICAN MEDICAL ISOTOPES PRODUCTION ACT 

JANUARY 28, 2010.—Ordered to be printed 

Mr. BINGAMAN, from the Committee on Energy and Natural 

Resources, submitted the following 

R E P O R T 

[To accompany H.R. 3276] 

The Committee on Energy and Natural Resources, to which was 

referred the Act (H.R. 3276) to promote the production of molybdenum-99 in the United States for medical isotope production, and 

to condition and phase out the export of highly enriched uranium 

for the production of medical isotopes, having considered the same, 

reports favorably thereon with amendments and recommends that 

the Act, as amended, do pass. 

The amendments are as follows: 

On page 2, line 3, strike ‘‘2009’’ and insert ‘‘2010’’. 

Beginning on page 2, strike line 4 and all that follows through 

page 6, line 3. 

On page 6, line 4, strike ‘‘3’’ and insert ‘‘2’’. 

On page 6, strike lines 8 through 12 and insert the following: 

shall establish a technology-neutral program— 

(A) to evaluate and support projects for the production 

in the United States, without the use of highly enriched 

uranium, of significant quantities of molybdenum-99 for 

medical uses; 

(B) to be carried out in cooperation with non-Federal entities; and 

(C) the costs of which shall be shared in accordance with 

section 988 of the Energy Policy Act of 2005 (42 U.S.C. 

16352). 

On page 7, between lines 17 and 18, insert the fol1owing: 

(4) PUBLIC PARTICIPATION AND REVIEW.—The Secretary of 

Energy shall— 

(A) develop a program plan and annually update the 

program plan through public workshops; and 


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(B) use the Nuclear Science Advisory Committee to conduct annual reviews of the progress made in achieving the 

program goals. 

On page 7, line 18, strike ‘‘(4)’’ and insert ‘‘(5)’’. 

On page 9, line 1, strike ‘‘4’’ and insert ‘‘3’’. 

On page 9, line 3, strike ‘‘2160d(b)’’ and insert ‘‘2160d’’. 

On page 9, line 6, strike ‘‘2009’’ and insert ‘‘2010’’. 

On page 9, line 11, strike ‘‘four’’ and insert ‘‘6’’. 

On page 9, line 13, strike ‘‘2009’’ and insert ‘‘2010’’. 

On page 9, after line 25, insert the following: 

‘‘d. To ensure public review and comment, the development of the 

certification described in subsection c. shall be carried out through 

announcement in the Federal Register. 

On page 10, line 1, strike ‘‘d.’’ and insert ‘‘e.’’. 

On page 10, line 14, strike ‘‘passes’’ and insert ‘‘enacts’’. 

On page 10, line 17, strike ‘‘e.’’ and insert ‘‘f.’’. 

On page 11, line 18, strike ‘‘5’’ and insert ‘‘4’’. 

On page 12, line 15, strike ‘‘6’’ and insert ‘‘5’’. 

On page 14, lines 16 and 17, strike ‘‘after the item relating to 

section 111:’’ and insert ‘‘at the end of the items relating to chapter 

10 of title I:’’. 

On page 14, line 18, strike ‘‘7’’ and insert ‘‘6’’. 

On page 15, line 3, strike ‘‘section 3’’ and insert ‘‘section 2’’. 

On page 15, line 14, strike ‘‘3(a)(2)’’ and insert ‘‘2(a)(2)’’. 

On page 15, line 17, strike ‘‘section 3’’ and insert ‘‘section 2’’. 

On page 15, line 22, strike ‘‘8’’ and insert ‘‘7’’. 

On page 16, line 24, strike ‘‘coproduced’’ and insert ‘‘that have 

been produced’’. 

On page 17, line 8, strike ‘‘9’’ and insert ‘‘8’’. 

PURPOSE

The purpose of H.R. 3276 is to promote the domestic production 

of molybdenum-99 for medical isotope production and to condition 

and phase out the export of highly enriched uranium for the production of medical isotopes. 

BACKGROUND AND NEED

Molybdenum-99 and its decay product, technetium-99, are the 

workhorses of nuclear medicine. Molybdenum-99 is produced by irradiating a uranium-235 target in a nuclear reactor, which causes 

the uranium-235 atoms to split into molybdenum-99 and other fission products. Molybdenum-99 is then chemically separated from 

the other fission products, collected in small cylinders known as 

technetium generators, and shipped to radiopharmacies and hospitals. 

Molybdenum-99 is unstable. Half of any given amount decays in 

about 66 hours, producing technetium-99. Technetium-99 is recovered from the generator and used in medical diagnostic imaging of 

the brain, kidney, heart, bone, liver, and lung. Technetium-99, like 

molybdenum-99 is unstable; half of any given amount decays in 

about 6 hours. A technetium generator only lasts about 6 days. 

The production of molybdenum-99 and technetium-99 are extremely important to the detection and treatment of disease. Technetium-99 is used in two-thirds of the 16 million nuclear medical 


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procedures performed in the United States each year, which 

amounts to about 41,000 uses per day. Because of their short ‘‘halflives,’’ neither molybdenum-99 nor technetium-99 can be stockpiled. 

They must be produced on an ongoing and reliable basis to ensure 

constant availability for necessary medical procedures. 

The United States consumes half of the world’s supply of molybdenum-99, but since 1989 has had no domestic source of supply. 

Between 95 and 98 percent of the world’s molybdenum-99 is produced by four companies based in Canada, Belgium, the Netherlands, and South Africa. The United States is dependent on two of 

these companies: MDS Nordion, which is based in Canada and supplies 60 percent of our needs; and Mallinckrodt, which is based in 

the Netherlands and supplies the remaining 40 percent. 

The United States currently faces a severe shortage of molybdenum-99 and technetium-99. The Canadian reactor that produces 

molybdenum-99 has been shut down since May 2009 and is not expected to be back in operation until the spring of 2010. The Netherlands reactor is also scheduled to be shut down for repairs for several months in early 2010. 

In addition to the current supply concerns, molybdenum-99 production has long posed nuclear proliferation concerns. All four of 

the companies that are responsible for 95 to 98 percent of the 

world’s production use highly enriched uranium targets to produce 

molybdenum-99. The United States is the world’s primary supplier 

of the highly enriched uranium used for molybdenum-99 production. Highly enriched uranium, if obtained by terrorists or a rogue 

state, could be used to produce a nuclear weapon. 

As a result of the nuclear proliferation concern, the Energy Policy Act of 1992 amended the Atomic Energy Act of 1954 to restrict 

the export of highly enriched uranium. The Energy Policy Act of 

2005 subsequently relaxed this restriction to permit exports to certain countries to continue for medical isotope production. In addition, the Energy Policy Act of 2005 asked the National Academy of 

Sciences to determine if it is feasible to obtain medical isotopes 

from sources using low enriched uranium targets. 

The National Academy of Sciences published its report, Medical 

Isotope Production Without Highly Enriched Uranium, in January 

2009. The Academy found that although, at present, sufficient 

quantities of medical isotopes to meet our domestic needs cannot 

be produced without highly enriched uranium, there is no technical 

reason that adequate quantities could not be produced using low 

enriched uranium targets. It noted that Argentina and Australia 

are already producing molybdenum-99 with low enriched uranium 

targets, though in relatively small quantities sufficient only to 

meet their regional needs. It also found that use of highly enriched 

uranium targets could be phased out and replaced by low enriched 

uranium targets in 7 to 10 years. This conclusion was further bolstered by the November 2009 Report of the Export Review Panel 

to Canada’s Minister of Natural Resources, which recommended 

that any new reactor-based source of molybdenum-99 use low enriched uranium. 

H.R. 3276 is needed to facilitate the conversion of medical isotope 

production from the use of highly enriched to low enriched uranium 

both by directing the Secretary of Energy to establish a program 

to support the production of molybdenum-99 without the use of 


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highly enriched uranium and by phasing out the export of highly 

enriched uranium. 

LEGISLATIVE HISTORY

H.R. 3276 was introduced by Representative Markey on July 21, 

2009, was reported by the Committee on Energy and Commerce on 

November 4, 2009 (H. Rept. 111–328), and passed the House on 

November 5, 2009 by a vote of 400 to 17. 

The Committee on Energy and Natural Resources held a hearing 

on H.R. 3276 on December 3, 2009, and ordered it favorably reported, with amendments, on December 16, 2009. 

COMMITTEE RECOMMENDATION

The Senate Committee on Energy and Natural Resources, in 

open business session on December 16, 2009, by a voice vote of a 

quorum present recommends that the Senate pass H.R. 3276, if 

amended as described herein. 

COMMITTEE AMENDMENTS

During its consideration of H.R. 3276, the Committee adopted 19 

numbered amendments and the staff made 6 technical or clerical 

corrections pursuant to rule 7(d) of the Rules of the Committee. 

The first amendment updates the year in the short title. 

The second strikes the findings; and the third makes a conforming change to a section number. 

The fourth adds to the requirement that the Secretary of Energy 

establish a program to evaluate and support projects for the production of molybdenum-99 without the use of highly enriched uranium the additional requirements that the program be technology 

neutral, that it be carried out in cooperation with non-Federal entities, and that the costs be shared in accordance with section 988 

of the Energy Policy Act of 2005. 

The fifth requires the Secretary of Energy to develop a program 

plan and annually update it through public workshops, and to use 

the Nuclear Science Advisory Committee to conduct annual reviews 

of the progress made in achieving the program goals. 

The eighth corrects a citation, and the sixth, seventh, ninth, and 

eleventh make conforming changes. 

The tenth amendment lengthens the period of time by which the 

initial 7-year period during which the Nuclear Regulatory Commission may issue export licenses for highly enriched uranium for 

medical isotope production may be extended from 4 years to 6 

years. 

The twelfth amendment provides for public notice and comment 

on the certification needed to trigger an extension of the period of 

time during which the Nuclear Regulatory Commission may issue 

export licenses for highly enriched uranium. 

The fourteenth and twenty-fourth amendments make technical 

clarifications, and the remaining amendments (numbered 13, 15 

through 23, and 25) make conforming changes. 

SECTION-BY-SECTION ANALYSIS

Section 1 provides a short title. 


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Section 2(a)(1) directs the Secretary of Energy (the Secretary) to 

establish a technology-neutral program to evaluate and support 

projects for the production of molybdenum-99 for medical uses 

without the use of highly enriched uranium. 

Subsection (a)(2) provides criteria for evaluating projects. 

Subsection (a)(3) permits existing reactors fueled with highly enriched uranium to participate in the program under specified conditions. 

Subsection (a)(4) requires the Secretary to develop and update a 

program plan through public workshops, and to use the Nuclear 

Science Advisory Committee to review program progress. Subsection (a)(5) authorizes $163 million to be appropriated to 

the Secretary for fiscal years 2010 through 2014 to carry out the 

program. 

Subsection (b) directs the Secretary to establish a program to 

provide assistance for the development of fuels, targets, and processes for production of molybdenum-99 without the use of highly 

enriched uranium, and for commercial operations using such fuels, 

targets, and processes. 

Subsection (c) directs the Secretary to establish a program to 

lease low enriched uranium for use in the production of molybdenum-99 for medical uses, and for taking back and disposing of 

radioactive waste created by the irradiation, processing, or purification of leased uranium. 

Section 3 amends section 134 of the Atomic Energy Act of 1954, 

42 U.S.C. 2160d, by striking subsection (b) (as added by section 630 

of the Energy Policy Act of 2005) and subsection (c), and by adding 

5 new subsections designated (b) through (f). New subsection (b) 

prohibits the Nuclear Regulatory Commission from issuing a license for the export of highly enriched uranium for medical isotope 

production effective 7 years after the date of enactment. 

Subsection (c) permits the 7-year period in subsection (b) to be 

extended for up to 6 additional years if the Secretary certifies that 

there is insufficient global supply of molybdenum-99 produced 

without the use of highly enriched uranium to satisfy the domestic 

market and that the export of highly enriched uranium is the most 

effective temporary means to increase the domestic supply of molybdenum-99. 

Subsection (d) requires public notice and comment on the certification. 

Subsection (e) provides for the suspension, for up to 12 months, 

of the prohibition on the export licensing of highly enriched uranium after it has become effective if there is a critical shortage of 

molybdenum-99, the Secretary certifies that the export of highly 

enriched uranium is the only effective temporary means to increase 

the supply, and Congress enacts a joint resolution approving the 

temporary suspension. 

Subsection (f) defines terms used in section 134 of the Atomic 

Energy Act of 1954. 

Section 4 requires the Chairman of the Nuclear Regulatory Commission to submit to Congress a report on the current disposition 

of previous exports of highly enriched uranium. 

Section 5 adds a new section 112 to the Atomic Energy Act of 

1954 to authorize the Nuclear Regulatory Commission to license 

the use in the United States of highly enriched uranium as a target 


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for medical isotope production only if, in addition to other requirements of the Atomic Energy Act, the Commission determines that 

no low enriched uranium target can be used in the reactor, and the 

recipient has provided assurances that if a low enriched uranium 

target can be used, it will be, and the Secretary certifies that the 

United States Government is actively supporting the development 

of low enriched uranium targets for the reactor. 

Section 6 requires the Secretary to report to Congress one year 

after the date of enactment of H.R. 3276, and annually for the ensuing 5 years, on actions to support the production of molybdenum99 for medical uses without the use of highly enriched uranium. 

Section 7 requires the National Academy of Sciences to study the 

state of molybdenum-99 production and use not later than 5 years 

after the date of enactment of H.R. 3276. 

Section 8 defines terms used in the Act. 

COST AND BUDGETARY CONSIDERATIONS

The following estimate of costs of this measure has been provided 

by the Congressional Budget Office. 

H.R. 3276—American Medical Isotopes Production Act of 2009 

Summary: H.R. 3276 would authorize funding to support projects 

to produce molybdenum-99, a radioactive isotope used in certain 

medical procedures. Assuming appropriation of the authorized 

amounts, CBO estimates that implementing the act would cost 

$165 million over the 2010–2015 period. CBO also estimates that 

enacting H.R. 3276 would have a negligible net impact on direct 

spending for any given year. The act would not affect revenues. 

H.R. 3276 contains no intergovernmental or private-sector mandates as defined in the Unfunded Mandates Reform Act (UMRA) 

and would impose no costs on state, local, or tribal governments. 

Estimated cost to the Federal Government: The estimated budgetary impact of H.R. 3276 is shown in the following table. The costs 

of this legislation fall within budget function 270 (energy). 

By fiscal year, in millions of dollars— 

2010 2011 2012 2013 2014 2015 2010– 

2015 

CHANGES IN SPENDING SUBJECT TO APPROPRIATION 

Estimated Authorization Level ................................................. 165 0 0 0 0 0 165 

Estimated Outlays ................................................................... 12 25 30 30 33 35 165 

Basis of Estimate: H.R. 3276 would authorize the appropriation 

of $163 million to support projects to produce molybdenum-99, a radioactive isotope produced from uranium, for use in certain medical 

procedures. In addition to direct financial support for those 

projects, the act would direct the Secretary of Energy to make lowenriched uranium (LEU) available through lease contracts to producers of molybdenum-99. Such lease contracts would provide for 

the Secretary to retain financial responsibility for radioactive waste 

generated by the irradiation, processing, or purification of LEU. 

CBO estimates that providing funding for proposed projects, completing related studies and reports, and managing radioactive 


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waste resulting from leases of LEU would cost $165 million over 

the 2010–2015 period. We also estimate that leasing LEU would 

have a negligible net impact on direct spending. 

SPENDING SUBJECT TO APPROPRIATION

CBO estimates that implementing H.R. 3276 would require ap- propriations totaling $165 million over the 2010–2015 period. That 

amount includes $163 million specifically authorized to support 

projects to produce molybdenum-99 and $2 million for related studies, reports, and regulatory activities. Assuming appropriation of 

those amounts, CBO estimates that spending would total $165 million over the 2010–2015 period. That estimate is based on information from the Department of Energy (DOE) about the types of molybdenum-99 projects that might be supported under H.R. 3276 and 

takes into account historical spending patterns for similar activities. 

Under H.R. 3276, the federal government would be responsible 

for disposing of radioactive waste generated by molybdenum-99 

producers who lease LEU from DOE. Because the act would prohibit DOE from using certain existing barter authorities to obtain 

waste-disposal services in exchange for commercially valuable uranium owned by DOE, CBO believes that any spending to dispose 

of waste generated under such leases would be subject to the availability of appropriated funds. Based on information from DOE 

about the relatively small volume of LEU the agency anticipates 

would be leased under H.R. 3276, CBO expects that resulting 

quantities of waste would be small. While such costs would be incurred over many years and may reach significant levels over time, 

CBO estimates that increased costs over the 2010–2015 period 

would not exceed $500,000 in any year. 

DIRECT SPENDING

H.R. 3276 would direct the Secretary to lease LEU to producers 

of molybdenum-99. Under current law, CBO estimates that sales of 

the material that would be leased under the act would otherwise 

generate offsetting receipts totaling about $1 million annually. Because H.R. 3276 would require that lessees pay fees equivalent to 

the prevailing market rates for the sale of comparable uranium 

products, CBO estimates that any differences in receipts generated 

under the act would be negligible in any given year. 

The act also would require the Secretary to charge lessees a fee 

to offset the net present value of DOE’s anticipated costs to dispose 

of radioactive waste generated from leased LEU. As discussed 

above (under ‘‘spending subject to appropriation’’), CBO expects 

that such costs would be small and estimates that resulting fees 

would not exceed $500,000 in any year. 

Intergovernmental and private-sector impact: H.R. 3276 contains 

no intergovernmental or private-sector mandates as defined in 

UMRA and would impose no costs on state, local, or tribal governments. 

Previous CBO estimate: On October 27, 2009, CBO transmitted 

a cost estimate for H.R. 3276 as ordered reported by the House 

Committee on Energy and Commerce on October 21, 2009. The two 

versions of the legislation are similar, and our estimates of spending over the 2010–2014 period are the same. This estimate of H.R. 


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3276 as ordered reported by the Senate Committee on Energy and 

Natural Resources includes anticipated spending in 2015. 

Estimate prepared by: Federal Costs: Megan Carroll and Kathleen Gramp; Impact on State, Local, and Tribal Governments: 

Ryan Miller; Impact on the Private Sector: Sam Wice and Amy 

Petz. 

Estimate approved by: Theresa Gullo, Deputy Assistant Director 

for Budget Analysis. 

REGULATORY IMPACT EVALUATION

In compliance with paragraph 11(b) of rule XXVI of the Standing 

Rules of the Senate, the Committee makes the following evaluation 

of the regulatory impact which would be incurred in carrying out 

H.R. 3276. 

The bill is not a regulatory measure in the sense of imposing 

Government established standards or significant economic responsibilities on private individuals and businesses. 

No personal information would be collected in administering the 

program. Therefore, there would be no impact on personal privacy. 

Little, if any, additional paperwork would result from the enactment of H.R. 3276. 

CONGRESSIONALLY DIRECTED SPENDING

H.R. 3276, as reported, does not contain congressionally directed 

spending items, limited tax benefits, or limited tariff benefits as defined in rule XLIV of the Standing Rules of the Senate. 

EXECUTIVE COMMUNICATIONS

The testimony of the National Nuclear Security Administration 

at the Committee’s hearing on H.R. 3276 follows: 

STATEMENT OF DR. PARRISH STAPLES, DIRECTOR, OFFICE

OF EUROPEAN AND AFRICAN THREAT REDUCTION, GLOBAL

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

Chairman Bingaman, Ranking Member Murkowski, and 

Committee Members, thank you for the opportunity to testify about the National Nuclear Security Administration’s 

(NNSA’s) efforts to minimize and, where possible, eliminate the use of highly enriched uranium (HEU) in civilian 

nuclear applications, including in the production of medical radioisotopes. My testimony will include a description 

of the benefits of the proposed American Medical Isotopes 

Production Act of 2009, the NNSA’s effort to mitigate the 

impact of the current and anticipated shortages of the 

medical isotope Molybdenum-99 (Mo-99), and the efforts to 

accelerate the establishment of a domestic commercial supply of Mo-99 without using HEU. 

As described in Section 2 of the American Medical Isotopes Production Act of 2009, Mo-99 is the parent isotope 

of Technetium-99m, which is used in approximately 50,000 

diagnostic medical isotope procedures every day in the 

United States. It has a very short half life and therefore 


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cannot be stockpiled. It must be produced on a continuous 

basis to meet the needs of the medical community, and any 

interruptions in production can place patients’ health at 

risk if diagnostic tests cannot be performed. Currently, the 

United States depends entirely on foreign producers for all 

of its Mo-99, and these producers use highly enriched uranium (HEU) targets to produce this vital medical isotope. 

Historically, Mo-99 production processes have utilized 

the same form of HEU that can be used to produce nuclear 

weapons and nuclear explosive devices. Underscoring the 

global recognition of the grave threat posed by HEU falling 

into the wrong hands, including the risk of terrorists or 

rogue states acquiring such material, new technical advances in Mo-99 production processes—just as in other civilian applications—are demonstrating that HEU is no 

longer required. Provisions of this legislation, in particular 

Section 2, paragraph (11) are aligned with the NNSA’s 

mission to convert or assist in the conversion of research 

reactors worldwide from the use of HEU-based to LEU 

fuels and to convert medical isotope production from HEU 

to non-HEU based production. 

The American Medical Isotopes Production Act of 2009 

under review by this committee would provide a long-term 

authorization to address this critical medical need by developing a domestic source of Mo-99 as well as furthering 

global HEU minimization efforts by ensuring that new domestic supplies of Mo-99 are non HEU-based. The proposed legislation will greatly promote the reliable supply of 

Mo-99 to hospitals throughout our country and will ultimately ensure the level of patient care that our citizens require. 

The Mo-99 shortages over the last few years are due to 

both unforeseen and required maintenance to the aging reactors around the world that provide the global supply. In 

May 2009, the fragile supply chain for Mo-99 was significantly threatened by the unexpected shutdown of the primary supplier for the U.S. due to a serious maintenance 

concern. In 2010, this unexpected supply interruption will 

be exacerbated by the required scheduled maintenance of 

the second largest global supplier. The Office of Science 

and Technology Policy of the Executive Office of the President is directing an Inter-agency working group, which includes NNSA and other Department of Energy offices, to 

investigate options to focus on near-term efforts to increase 

the supply to the U.S. during periods when the major suppliers will be out of operation, and prior to the development of new longer-term production capabilities. The current Mo-99 shortages are being mitigated as effectively as 

possible in the near-term through industry-wide communication, scheduling and more efficient use of available 

Mo-99 supplies, the application of alternate diagnostic 

technologies and increased production from all of the global producers. Near-term production and the significant 

amount of attention focused to address this problem needs 

to be carefully balanced with other efforts to ensure the 


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development of a long-term reliable supply of non-HEU 

based Mo-99. With appropriate Congressional support, the 

long-term options could be readily achievable and available 

for steady state production with the objective to create a 

consistent supply of the medical isotope to health care providers. 

The National Academies published a report on January 

14, 2009 confirming that the production of Mo-99 without 

the use of HEU is both technically and economically feasible. It was the National Academies’ determination that 

there are ‘‘no technical reasons that adequate quantities 

[of medical isotopes] cannot be produced’’ without the use 

of HEU, and furthermore, that ‘‘. . . the greatest single 

threat to supply reliability is the approaching obsolescence 

of the aging reactors that large-scale producers utilize to 

irradiate HEU target to obtain Mo-99.’’ The report positively supports HEU minimization by establishing that it 

is feasible for global producers to convert to LEU, and 

identifying the risk to the domestic supply reliability. 

To address the longer-term production of Mo-99, NNSA 

is developing projects to accelerate the establishment of 

domestic commercial sources of Mo-99 without HEU. To 

prevent the single point of failure scenario facing today’s 

U.S. Mo-99 supply, NNSA is helping demonstrate the feasibility of non-HEU based Mo-99 production by working 

with commercial entities and national laboratories on four 

technology pathways. These include: LEU fission technology; LEU solution reactor technology; neutron capture 

technology; and accelerator technology. The goal is for each 

technology to be commercially successful, and NNSA’s approach is technology neutral. NNSA is working with the 

one commercial partner in each of the four areas whose 

projects on Mo-99 are most advanced for that technical 

pathway. NNSA also makes available the technical expertise of the U.S. national laboratories gained over many 

years in the non-HEU based Mo-99 production technologies. The commercialization of these different nonHEU based technologies supports the strategy to diversify 

the Mo-99 supply and move away from reliance on a sole 

technology and a limited number of facilities, as is the case 

with today’s foreign producers. 

NNSA is planning to spend approximately $20 million in 

FY 2010 to establish these technologies. Funding would 

come from within the Global Threat Reduction Initiative 

budget. As with any major technology initiative, there are 

challenges that could affect the acceleration of these technologies that must be addressed. We must overcome the 

technical difficulty involved in extracting the final medical 

product and processing it into a form that meets Food and 

Drug Administration (FDA) standards, and doing so 

steady-state on a commercial scale suitable to meet the 

needs of the medical community. The production of this 

valuable commodity is a complex endeavor and lessons 

learned from two experienced commercial-scale producers 

that have initiated recent projects to construct new producVerDate Nov 24 2008 00:07 Jan 30, 2010 Jkt 089010 PO 00000 Frm 00010 Fmt 6659 Sfmt 6969 E:\HR\OC\SR120.XXX SR120

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tion capabilities must be considered to minimize difficulties as we proceed. There are many research reactor operators globally that contend they can produce Mo-99, but we 

must not underestimate the difficulties to be overcome in 

the process to provide material at the standards required 

and on a scale to satisfy global demand. We must maintain 

our focus on supporting the demonstration of commercial 

scale Mo-99 production by those few specific entities that 

are most advanced under the technology-neutral process 

we have developed. We share the goals of this bill and look 

forward to working with you to ensure the accomplishment 

of nuclear threat reduction activities and the development 

of a reliable supply of medical isotopes to the public, while 

ensuring greater Presidential flexibility. 

This legislation will provide the national visibility necessary to address this critical medical need as rapidly as 

possible and will also achieve important nonproliferation 

goals. I thank Senator Bingaman and the Committee for 

your continued leadership by supporting this legislation. 

CHANGES IN EXISTING LAW

In compliance with paragraph 12 of rule XXVI of the Standing 

Rules of the Senate, changes in existing law made by the bill H.R. 

3276, as ordered reported, are shown as follows (existing law proposed to be omitted is enclosed in black brackets, new matter is 

printed in italic, existing law in which no change is proposed is 

shown in roman): 

ATOMIC ENERGY ACT OF 1954 

Act of August 1, 1946, ch. 724, as Amended 

Be it enacted by the Senate and House of Representatives of the 

United States of America in Congress assembled, 

ATOMIC ENERGY ACT OF 1954 

TABLE OF CONTENTS

TITLE I—ATOMIC ENERGY

* * * * * * * 

CHAPTER 10. ATOMIC ENERGY LICENSES

* * * * * * * 

Sec. 110. Exclusions. 

Sec. 112. Domestic medical isotope production. 

* * * * * * * 

TITLE I—ATOMIC ENERGY 

* * * * * * * 

CHAPTER 10. ATOMIC ENERGY LICENSES 

* * * * * * * 

SEC. 111. a. The Nuclear Regulatory Commission is authorized to 

license the distribution of special nuclear material, source material, 


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and byproduct material by the Department of Energy pursuant to 

section 54, 64, and 82 of this Act, respectively, in accordance with 

the same procedures established by law for the export licensing of 

such material by any person: Provided, That nothing in this section 

shall require the licensing of the distribution of byproduct material 

by the Department of Energy under section 82 of this Act. 

b. The Department of Energy shall not distribute any special nuclear material or source material under section 54 or 64 of this Act 

other than under an export license issued by the Nuclear Regulatory Commission until (1) the Department has obtained the concurrence of the Department of State and has consulted with the 

Nuclear Regulatory Commission and the Department of Defense 

under mutually agreed procedures which shall be established within not more than ninety days after the date of enactment of this 

provision and (2) the Department finds based on a reasonable judgment of the assurances provided and the information available to 

the United States Government, that the criteria in section 127 of 

this Act or their equivalent and any applicable criteria in subsection 128 are met, and that the proposed distribution would not 

be inimical to the common defense and security. 

SEC. 112. DOMESTIC MEDICAL ISOTOPE PRODUCTION. (a) The 

Commission may issue a license, or grant an amendment to an existing license, for the use in the United States of highly enriched 

uranium as a target for medical isotope production in a nuclear reactor, only if in addition to any other requirement of this Act— 

(1) the Commission determines that— 

(A) there is no alternative medical isotope production target, enriched in the isotope U–235 to less than 20 percent, 

that can be used in that reactor; and 

(B) the proposed recipient of the medical isotope production target has provided assurances that, whenever an alternative medical isotope production target can be used in 

that reactor, it will use that alternative in lieu of highly enriched uranium; and 

(2) the Secretary of Energy has certified that the United 

States Government is actively supporting the development of an 

alternative medical isotope production target that can be used 

in that reactor. 

(b) As used in this section— 

(1) the term ‘‘alternative medical isotope production target’’ 

means a nuclear reactor target which is enriched to less than 

20 percent of the isotope U–235; 

(2) a target ‘‘can be used’’ in a nuclear research or test reactor 

if— 

(A) the target has been qualified by the Reduced Enrichment Research and Test Reactor Program of the Department of Energy; and 

(B) use of the target will permit the large majority of ongoing and planned experiments and isotope production to 

be conducted in the reactor without a large percentage increase in the total cost of operating the reactor; 

(3) the term ‘‘highly enriched uranium’’ means uranium enriched to 20 percent or more in the isotope U–235; and 

(4) the term ‘‘medical isotope’’ includes molybdenum-99, iodine-131, xenon-133, and other radioactive materials used to 


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produce a radiopharmaceutical for diagnostic, therapeutic procedures or for research and development. 

CHAPTER 11. INTERNATIONAL ACTIVITIES 

* * * * * * * 

SEC. 134. FURTHER RESTRICTIONS ON EXPORTS. 

(a) IN GENERAL.—Except as provided in subsection b., the Commission may issue a license for the export of highly enriched uranium to be used as a fuel or target in a nuclear research or test 

reactor only if, in addition to any other requirements of this Act, 

the Commission determines that— 

(1) there is no alternative nuclear reactor fuel or target enriched in the isotope 235 to a lesser percent than the proposed 

export, that can be used in that reactor; 

(2) the proposed recipient of that 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 highly enriched uranium; and 

(3) the United States Government is actively developing an 

alternative nuclear reactor fuel or target that can be used in 

that reactor. 

øb. MEDICAL ISOTOPE PRODUCTION.— ø(1) DEFINITIONS.—In this subsection: 

ø(A) HIGHLY ENRICHED URANIUM.—The term ‘‘highly enriched uranium’’ means uranium enriched to include concentration of U–235 above 20 percent. 

ø(B) MEDICAL ISOTOPE.—The term ‘‘medical isotope’’ includes Molybdenum 99, Iodine 131, Xenon 133, and other 

radioactive materials used to produce a radiopharmaceutical for diagnostic, therapeutic procedures or for research and development. 

ø(C) RADIOPHARMACEUTICAL.—The term ‘‘radiopharmaceutical’’ means a radioactive isotope that— 

ø(i) contains byproduct material combined with 

chemical or biological material; and 

ø(ii) is designed to accumulate temporarily in a part 

of the body for therapeutic purposes or for enabling 

the production of a useful image for use in a diagnosis 

of a medical condition. 

ø(D) RECIPIENT COUNTRY.—The term ‘‘recipient country’’ 

means Canada, Belgium, France, Germany, and the Netherlands. 

ø(2) LICENSES.—The Commission may issue a license authorizing the export (including shipment to and use at intermediate and ultimate consignees specified in the license) to a 

recipient country of highly enriched uranium for medical isotope production if, in addition to any other requirements of this 

Act (except subsection a.), the Commission determines that— 

ø(A) a recipient country that supplies an assurance letter to the United States Government in connection with 

the consideration by the Commission of the export license 

application has informed the United States Government 

that any intermediate consignees and the ultimate consignee specified in the application are required to use the 


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highly enriched uranium solely to produce medical isotopes; and 

ø(B) the highly enriched uranium for medical isotope 

production will be irradiated only in a reactor in a recipient country that— 

ø(i) uses an alternative nuclear reactor fuel; or 

ø(ii) is the subject of ar, agreement with the United 

States Government to convert to an alternative nuclear reactor fuel when alternative nuclear reactor fuel 

can be used in the reactor. 

ø(3) REVIEW OF PHYSICAL PROTECTION REQUIREMENTS.— ø(A) IN GENERAL.—The Commission shall review the 

adequacy of physical protection requirements that, as of 

the date of an application under paragraph (2), are applicable to the transportation and storage of highly enriched 

uranium for medical isotope production or control of residual material after irradiation and extraction of medical isotopes. 

ø(B) IMPOSITION OF ADDITIONAL REQUIREMENTS.—If the 

Commission determines that additional physical protection 

requirements are necessary (including a limit on the quantity of highly enriched uranium that may be contained in 

a single shipment), the Commission shall impose such requirements as license conditions or through other appropriate means. 

ø(4) FIRST REPORT TO CONGRESS.— ø(A) NAS STUDY.—The Secretary shall enter into an arrangement with the National Academy of Sciences to conduct a study to determine— 

ø(i) the feasibility of procuring supplies of medical 

isotopes from commercial sources that do not use highly enriched uranium; 

ø(ii) the current and projected demand and availability of medical isotopes in regular current domestic 

use; 

ø(iii) the progress that is being made by the Department of Energy and others to eliminate all use of highly enriched uranium in reactor fuel, reactor targets, 

and medical isotope production facilities; and 

ø(iv) the potential cost differential in medical isotope 

production in the reactors and target processing facilities if the products were derived from production systems that do not involve fuels and targets with highly 

enriched uranium. 

ø(B) FEASIBILITY.—For the purpose of this subsection, 

the use of low enriched uranium to produce medical isotopes shall be determined to be feasible if— 

ø(i) low enriched uranium targets have been developed and demonstrated for use in the reactors and target processing facilities that produce significant quantities of medical isotopes to serve United States needs 

for such isotopes; 

ø(ii) sufficient quantities of medical isotopes are 

available from low enriched uranium targets and fuel 

to meet United States domestic needs; and 


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ø(iii) the average anticipated total cost increase from 

production of medical isotopes in such facilities without use of highly enriched uranium is less than 10 

percent. 

ø(C) REPORT BY THE SECRETARY.—Not later than 5 years 

after the date of enactment of the Energy Policy Act of 

2005, the Secretary shall submit to Congress a report 

that— 

ø(i) contains the findings of the National Academy of 

Sciences made in the study under subparagraph (A); 

and 

ø(ii) discloses the existence of any commitments 

from commercial producers to provide domestic requirements for medical isotopes without use of highly 

enriched uranium consistent with the feasibility criteria described in subparagraph (B) not later than the 

date that is 4 years after the date of submission of the 

report. 

ø(5) SECOND REPORT TO CONGRESS.—If the study of the National Academy of Sciences determines under paragraph 

(4)(A)(i) that the procurement of supplies of medical isotopes 

from commercial sources that do not use highly enriched uranium is feasible, but the Secretary is unable to report the existence of commitments under paragraph (4)(C)(ii), not later 

than the date that is 6 years after the date of enactment of the 

Energy Policy Act of 2005, the Secretary shall submit to Congress a report that describes options for developing domestic 

supplies of medical isotopes in quantities that are adequate to 

meet domestic demand without the use of highly enriched uranium consistent with the cost increase described in paragraph 

(4)(B)(iii). 

ø(6) CERTIFICATION.—At such time as commercial facilities 

that do not use highly enriched uranium are capable of meeting domestic requirements for medical isotopes, within the cost 

increase described in paragraph (4)(B)(iii) and without impairing the reliable supply of medical isotopes for domestic utilization, the Secretary shall submit to Congress a certification to 

that effect. 

ø(7) SUNSET PROVISION.—After the Secretary submits a certification under paragraph (6), the Commission shall, by rule, 

terminate its review of export license applications under this 

subsection. 

øc. As used in this section— 

ø(1) the term ‘‘alternative nuclear reactor fuel or target’’ 

means a nuclear reactor fuel or target which is enriched to less 

than 20 percent in the isotope U–235; 

ø(2) the term ‘‘highly enriched uranium’’ means uranium enriched to 20 percent or more in the isotope U–235; and 

ø(3) a fuel or target ‘‘can be used’’ in a nuclear research or 

test reactor if— 

ø(A) the fuel or target has been qualified by the Reduced 

Enrichment Research and Test Reactor Program of the Department of Energy, and 

ø(B) use of the fuel or target will permit the large majority of ongoing and planned experiments and isotope proVerDate Nov 24 2008 01:49 Jan 30, 2010 Jkt 089010 PO 00000 Frm 00015 Fmt 6659 Sfmt 6602 E:\HR\OC\SR120.XXX SR120

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duction to be conducted in the reactor without a large percentage increase in the total cost of operating the reactor.¿ 

(b) Effective 7 years after the date of enactment of the American 

Medical Isotopes Production Act of 2010, the Commission may not 

issue a license for the export of highly enriched uranium from the 

United States for the purposes of medical isotope production. 

(c) The period referred to in subsection (b) may be extended for 

no more than 6 years if, no earlier than 6 years after the date of 

enactment of the American Medical Isotopes Production Act of 2010, 

the Secretary of Energy certifies to the Committee on Energy and 

Commerce of the House of Representatives and the Committee on 

Energy and Natural Resources of the Senate that— 

(1) there is insufficient global supply of molybdenum-99 produced without the use of highly enriched uranium available to 

satisfy the domestic United States market; and 

(2) the export of United States-origin highly enriched uranium for the purposes of medical isotope production is the most 

effective temporary means to increase the supply of molybdenum-99 to the domestic United States market. 

(d) To ensure public review and comment, the development of the 

certification described in subsection c. shall be carried out through 

announcement in the Federal Register. 

(e) At any time after the restriction of export licenses provided for 

in subsection (b) becomes effective, if there is a critical shortage in 

the supply of molybdenum-99 available to satisfy the domestic 

United States medical isotope needs, the restriction of export licenses may be suspended for a period of no more than 12 months, 

if— 

(1) the Secretary of Energy certifies to the Congress that the 

export of United States-origin highly enriched uranium for the 

purposes of medical isotope production is the only effective temporary means to increase the supply of molybdenum-99 necessary to meet United States medical isotope needs during that 

period; and 

(2) the Congress enacts a Joint Resolution approving the temporary suspension of the restriction of export licenses. 

(f) As used in this section— 

(1) the term ‘‘alternative nuclear reactor fuel or target’’ means 

a nuclear reactor fuel or target which is enriched to less than 

20 percent in the isotope U–235; 

(2) the term ‘‘highly enriched uranium’’ means uranium enriched to 20 percent or more in the isotope U–235; 

(3) a fuel or target ‘‘can be used’’ in a nuclear research or test 

reactor if— 

(A) the fuel or target has been qualified by the Reduced 

Enrichment Research and Test Reactor Program of the Department of Energy; and 

(B) use of the fuel or target will permit the large majority 

of ongoing and planned experiments and isotope production 

to be conducted in the reactor without a large percentage 

increase in the total cost of operating the reactor; and 

(4) the term ‘‘medical isotope’’ includes molybdenum-99, iodine-131, xenon-133, and other radioactive materials used to 


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produce a radiopharmaceutical for diagnostic, therapeutic procedures or for research and development. 

Æ 


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