99–010 

Calendar No. 53 

112TH CONGRESS REPORT " ! SENATE 1st Session 112–17 

AMERICAN MEDICAL ISOTOPES PRODUCTION ACT 

MAY 18, 2011.—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 S. 99] 

The Committee on Energy and Natural Resources, to which was 

referred the bill (S. 99) to promote the production of molybdenum99 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 an amendment and recommends that the 

bill, as amended, do pass. 

The amendment is as follows: 

Strike out all after the enacting clause and insert in lieu thereof 

the following: 

SECTION 1. SHORT TITLE. 

This Act may be cited as the ‘‘American Medical Isotopes Production Act of 2011’’. 

SEC. 2. DEFINITIONS. 

In this Act: 

(1) DEPARTMENT.—The term ‘‘Department’’ means the Department of Energy. 

(2) HIGHLY ENRICHED URANIUM.—The term ‘‘highly enriched uranium’’ means 

uranium enriched to 20 percent or greater in the isotope U-235. 

(3) LOW ENRICHED URANIUM.—The term ‘‘low enriched uranium’’ means uranium enriched to less than 20 percent in the isotope U-235. 

(4) SECRETARY.—The term ‘‘Secretary’’ means the Secretary of Energy. 

SEC. 3. IMPROVING THE RELIABILITY OF DOMESTIC MEDICAL ISOTOPE SUPPLY. 

(a) MEDICAL ISOTOPE DEVELOPMENT PROJECTS.— 

(1) IN GENERAL.—The Secretary 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). 


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(2) CRITERIA.—Projects shall be judged against the following primary criteria: 

(A) The length of time necessary for the proposed project to begin production of molybdenum-99 for medical uses within the United States. 

(B) The capability of the proposed project to produce a significant percentage of United States demand for molybdenum-99 for medical uses. 

(C) The cost of the proposed project. 

(3) EXEMPTION.—An existing reactor in the United States fueled with highly 

enriched uranium shall not be disqualified from the program if the Secretary 

determines that— 

(A) there is no alternative nuclear reactor fuel, enriched in the isotope U235 to less than 20 percent, that can be used in that reactor; 

(B) the reactor operator has provided assurances that, whenever an alternative nuclear reactor fuel, enriched in the isotope U-235 to less than 20 

percent, can be used in that reactor, it will use that alternative in lieu of 

highly enriched uranium; and 

(C) the reactor operator has provided a current report on the status of 

its efforts to convert the reactor to an alternative nuclear reactor fuel enriched in the isotope U-235 to less than 20 percent, and an anticipated 

schedule for completion of conversion. 

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

(A) develop a program plan and annually update the program plan 

through public workshops; and 

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

(5) AUTHORIZATION OF APPROPRIATIONS.—There are authorized to be appropriated to the Secretary for carrying out the program under paragraph (1) 

$143,000,000 for the period encompassing fiscal years 2011 through 2014. 

(b) DEVELOPMENT ASSISTANCE.—The Secretary shall establish a program to provide assistance for— 

(1) the development of fuels, targets, and processes for domestic molybdenum99 production that do not use highly enriched uranium; and 

(2) commercial operations using the fuels, targets, and processes described in 

paragraph (1). 

(c) URANIUM LEASE AND TAKE-BACK.— 

(1) IN GENERAL.—The Secretary shall establish a program to make low-enriched uranium available, through lease contracts, for irradiation for the production of molybdenum-99 for medical uses. 

(2) TITLE.—The lease contracts shall provide for the producers of the molybdenum-99 to take title to and be responsible for the molybdenum-99 created by 

the irradiation, processing, or purification of uranium leased under this section. 

(3) DUTIES.— 

(A) SECRETARY.—The lease contracts shall require the Secretary— 

(i) to retain responsibility for the final disposition of spent nuclear 

fuel created by the irradiation, processing, or purification of uranium 

leased under this section for the production of medical isotopes; and 

(ii) to take title to and be responsible for the final disposition of radioactive waste created by the irradiation, processing, or purification of 

uranium leased under this section for which the Secretary determines 

the producer does not have access to a disposal path. 

(B) PRODUCER.—The producer of the spent nuclear fuel and radioactive 

waste shall accurately characterize, appropriately package, and transport 

the spent nuclear fuel and radioactive waste prior to acceptance by the Department. 

(4) COMPENSATION.— 

(A) IN GENERAL.—Subject to subparagraph (B), the lease contracts shall 

provide for compensation in cash amounts equivalent to prevailing market 

rates for the sale of comparable uranium products and for compensation in 

cash amounts equivalent to the net present value of the cost to the Federal 

Government for— 

(i) the final disposition of spent nuclear fuel and radioactive waste for 

which the Department is responsible under paragraph (3); and 

(ii) other costs associated with carrying out the uranium lease and 

take-back program authorized by this subsection. 

(B) DISCOUNT RATE.—The discount rate used to determine the net present 

value of costs described in subparagraph (A)(ii) shall be not greater than 

the average interest rate on marketable Treasury securities. 

(5) AUTHORIZED USE OF FUNDS.—The Secretary may obligate and expend 

funds received under leases entered into under this subsection, which shall remain available until expended, for the purpose of carrying out the activities auVerDate Mar 15 2010 06:11 May 19, 2011 Jkt 099010 PO 00000 Frm 00002 Fmt 6659 Sfmt 6621 E:\HR\OC\SR017.XXX SR017

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thorized by this Act, including activities related to the final disposition of spent 

nuclear fuel and radioactive waste for which the Department is responsible 

under paragraph (3). 

(6) EXCHANGE OF URANIUM FOR SERVICES.—The Secretary shall not barter or 

otherwise sell or transfer uranium in any form in exchange for— 

(A) services related to the final disposition of the spent nuclear fuel and 

radioactive waste for which the Department is responsible under paragraph 

(3); or 

(B) any other services associated with carrying out the uranium lease and 

take-back program authorized by this subsection. 

(d) COORDINATION OF ENVIRONMENTAL REVIEWS.—The Department and the Nuclear Regulatory Commission shall ensure to the maximum extent practicable that 

environmental reviews for the production of the medical isotopes shall complement 

and not duplicate each review. 

(e) OPERATIONAL DATE.—The Secretary shall establish a program as described in 

subsection (c)(3) not later than 3 years after the date of enactment of this Act. 

(f) RADIOACTIVE WASTE.—Notwithstanding section 2 of the Nuclear Waste Policy 

Act of 1982 (42 U.S.C. 10101), radioactive material resulting from the production 

of medical isotopes that has been permanently removed from a reactor or subcritical 

assembly and for which there is no further use shall be considered low-level radioactive waste if the material is acceptable under Federal requirements for disposal 

as low-level radioactive waste. 

(g) AUTHORIZATION OF APPROPRIATIONS.—There are authorized to be appropriated 

to the Secretary $5,000,000 for the establishment of a program for the final disposition of spent nuclear fuel and radioactive waste for which the Department is responsible under subsection (c). 

SEC. 4. EXPORTS. 

Section 134 of the Atomic Energy Act of 1954 (42 U.S.C. 2160d) is amended by 

striking subsection c. and inserting the following: 

‘‘c. Effective 7 years after the date of enactment of the American Medical Isotopes 

Production Act of 2011, 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. 

‘‘d. 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 2011, 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. 

‘‘e. 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. 

‘‘f. 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. 

‘‘g. 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 U235; 

‘‘(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 


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

planned experiments and medical 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, xenon133, and other radioactive materials used to produce a radiopharmaceutical for 

diagnostic or therapeutic procedures or for research and development.’’. 

SEC. 5. REPORT ON DISPOSITION OF EXPORTS. 

Not later than 1 year after the date of the enactment of this Act, the Chairman 

of the Nuclear Regulatory Commission, after consulting with other relevant agencies, shall submit to the Congress a report detailing the current disposition of previous United States exports of highly enriched uranium used as fuel or targets in 

a nuclear research or test reactor, including— 

(1) their location; 

(2) whether they are irradiated; 

(3) whether they have been used for the purpose stated in their export license; 

(4) whether they have been used for an alternative purpose and, if so, whether such alternative purpose has been explicitly approved by the Commission; 

(5) the year of export, and reimportation, if applicable; 

(6) their current physical and chemical forms; and 

(7) whether they are being stored in a manner which adequately protects 

against theft and unauthorized access. 

SEC. 6. DOMESTIC MEDICAL ISOTOPE PRODUCTION. 

(a) IN GENERAL.—Chapter 10 of the Atomic Energy Act of 1954 (42 U.S.C. 2131 

et seq.) is amended by adding at the end the following: 

‘‘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 medical 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, xenon133, and other radioactive materials used to produce a radiopharmaceutical for 

diagnostic or therapeutic procedures or for research and development.’’. 

(b) TABLE OF CONTENTS.—The table of contents for the Atomic Energy Act of 1954 

is amended by inserting the following new item at the end of the items relating to 

chapter 10 of title I: 

‘‘Sec. 112. Domestic medical isotope production.’’. 

SEC. 7. ANNUAL DEPARTMENT REPORTS. 

(a) IN GENERAL.—Not later than 1 year after the date of enactment of this Act, 

and annually thereafter for 5 years, the Secretary shall report to Congress on Department actions to support the production in the United States, without the use 

of highly enriched uranium, of molybdenum-99 for medical uses. 

(b) CONTENTS.—The reports shall include the following: 

(1) For medical isotope development projects— 


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(A) the names of any recipients of Department support under section 3; 

(B) the amount of Department funding committed to each project; 

(C) the milestones expected to be reached for each project during the year 

for which support is provided; 

(D) how each project is expected to support the increased production of 

molybdenum-99 for medical uses; 

(E) the findings of the evaluation of projects under section 3(a)(2); and 

(F) the ultimate use of any Department funds used to support projects 

under section 3. 

(2) A description of actions taken in the previous year by the Secretary to ensure the safe disposition of spent nuclear fuel and radioactive waste for which 

the Department is responsible under section 3(c). 

SEC. 8. NATIONAL ACADEMY OF SCIENCES REPORT. 

(a) IN GENERAL.—The Secretary shall enter into an arrangement with the National Academy of Sciences to conduct a study of the state of molybdenum-99 production and utilization, to be provided to Congress not later than 5 years after the 

date of enactment of this Act. 

(b) CONTENTS.—The report shall include the following: 

(1) For molybdenum-99 production— 

(A) a list of all facilities in the world producing molybdenum-99 for medical uses, including an indication of whether these facilities use highly enriched uranium in any way; 

(B) a review of international production of molybdenum-99 over the previous 5 years, including— 

(i) whether any new production was brought online; 

(ii) whether any facilities halted production unexpectedly; and 

(iii) whether any facilities used for production were decommissioned 

or otherwise permanently removed from service; and 

(C) an assessment of progress made in the previous 5 years toward establishing domestic production of molybdenum-99 for medical uses, including 

the extent to which other medical isotopes that have been produced with 

molybdenum-99, such as iodine-131 and xenon-133, are being used for medical purposes. 

(2) An assessment of the progress made by the Department and others to 

eliminate all worldwide use of highly enriched uranium in reactor fuel, reactor 

targets, and medical isotope production facilities. 

SEC. 9. BUDGETARY EFFECTS. 

The budgetary effects of this Act, for the purpose of complying with the Statutory 

Pay-As-You-Go-Act of 2010, shall be determined by reference to the latest statement 

titled ‘‘Budgetary Effects of PAYGO Legislation’’ for this Act, submitted for printing 

in the Congressional Record by the Chairman of the Senate Budget Committee, provided that such statement has been submitted prior to the vote on passage. 

PURPOSE

The purpose of S. 99 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-99m, are the 

workhorses of nuclear medicine. Currently, 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-99m. Technetium-99m is recovered from the generator and used in medical diagnostic imaging 

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


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

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-99m 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 approximately 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 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, 

historically supplies about 60 percent of our needs; and Mallinckrodt, which is based in the Netherlands and supplies the rest. 

Because the United States is 100 percent dependent upon foreign 

sources for these medical isotopes, any delay in their production 

could cause a shortage of molybdenum-99 and technetium-99m. For 

example, the Canadian reactor that produces molybdenum-99 was 

shut down between May 2009 and the fall of 2010. The Netherlands reactor was also shut down for repairs between February and 

the fall of 2010. The result of the outage of these two aging reactors was that there were days during the summer of 2010 when 

U.S. patients could not receive technetium-99m, thus forgoing important diagnostic procedures. These reactors are expected to shut 

down in 2016, thus exacerbating the shortage of technetium-99m to 

U.S. patients for the foreseeable future. 

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 


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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. 

S. 99 is needed to help facilitate the development of a stable domestic supply of molybdenum-99, as well as 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 technology neutral program to support the production of molybdenum-99 without the use of highly enriched uranium and by 

phasing out the export of highly enriched uranium. 

LEGISLATIVE HISTORY

S. 99 was introduced by Senator Bingaman on January 25, 2011. 

Senator Murkowski was an original cosponsor. As introduced, S. 99 

was identical to H.R. 3276, as reported by the Committee on Energy and Natural Resources, in the 111th Congress. 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 (S. Hrg. 111–314), and ordered 

it favorably reported, with amendments, on December 16, 2009. (S. 

Rept. 111–120.) 

The Committee held a hearing on S. 99 on February 1, 2011 (S. 

Hrg. 112–4), and ordered it favorably reported, with an amendment 

in the nature of a substitute, on April 12, 2011. 

COMMITTEE RECOMMENDATION

The Senate Committee on Energy and Natural Resources, in 

open business session on April 12, 2011, by a voice vote of a 

quorum present recommends that the Senate pass S. 99, if amended as described herein. 

COMMITTEE AMENDMENTS

During its consideration of S. 99, the Committee adopted an 

amendment in the nature of a substitute. The amendment makes 

a number of changes in the bill as introduced. 

New definitions for the terms ‘‘Department’’ and ‘‘Secretary’’ are 

added to the definition section, which is moved to the beginning of 

the bill and redesignated ‘‘section 2’’ instead of ‘‘section 8.’’ 

The exemption in section 3(a)(3) (formerly section 2(a)(3)), which 

permits existing reactors fueled with highly enriched uranium to 

participate in the development program, is restricted to reactors in 

the United States. 

The uranium lease and take-back program in section 3(c) (formerly section 4(c)) is clarified by providing that the producers will 

take title to the molybdenum-99, the Secretary will take title to the 

spent nuclear fuel and radioactive wastes for which the producers 

do not have access to a disposal path, and the producers will charVerDate Mar 15 2010 06:11 May 19, 2011 Jkt 099010 PO 00000 Frm 00007 Fmt 6659 Sfmt 6602 E:\HR\OC\SR017.XXX SR017

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acterize, package, and transport the spent nuclear fuel and radioactive waste prior to acceptance by the Department. Former section 

4(c) is further modified to require producers to compensate the Department for costs associated with the lease and take-back program 

(in the new section 3(c)(4)), to authorize the Secretary to spend 

funds received under the leases to carry out the program, including 

the disposal of radioactive waste for which the Department is responsible under the lease contracts (in section 3(c)(5)), and to clarify the restrictions on exchanging of uranium for services (in section 3(c)(6)). 

New subsections are added to require the Department and the 

Nuclear Regulatory Commission to coordinate environmental reviews for medical isotope production (section 3(d)), to require the 

Secretary to make the program to take back spent nuclear fuel and 

radioactive wastes operational within 3 years of the date of enactment (section 3(e)), to allow radioactive material resulting from the 

production of medical isotopes for which there is no further use to 

be treated as low-level radioactive waste if it meets federal requirements for disposal as low-level radioactive waste (section 3(f)), and 

to authorize appropriation of $5 million to establish the program to 

take back spent nuclear fuel and radioactive waste. 

Section 4 (formerly section 3) is modified to strike only section 

134c. (and not section 134b.) of the Atomic Energy Act of 1954. 

Section 5 (formerly section 4) is modified to require the Nuclear 

Regulatory Commission to report on the exports of highly enriched 

uranium used as fuel or isotope targets, rather than on all highly 

enriched uranium exports. 

SECTION-BY-SECTION ANALYSIS

Section 1 provides a short title. 

Section 2 defines terms used throughout the Act. 

Section 3(a)(1) directs the Secretary of Energy (the Secretary) to 

establish a technology-neutral, cost-shared 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 U.S. 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 $143 million to be appropriated to 

the Secretary for fiscal years 2011 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)(1) directs the Secretary to establish a program to 

supply, through lease contracts, low enriched uranium for use in 

the production of molybdenum-99 for medical uses. 


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Subsection (c)(2) requires that the lease contracts provide for the 

producers of molybdenum-99 to take title to and be responsible for 

the molybdenum-99 derived from the low enriched uranium. 

Subsection (c)(3)(A) requires the Secretary to be responsible for 

the final disposition of the spent nuclear fuel from the lease contracts and to take title to and be responsible for the waste created 

through the irradiation, processing, or purification of the low enriched uranium from the lease contracts for which the Secretary 

determines that the producer of the molybdenum-99 does not have 

a commercially available disposal path. 

Subsection (c)(3)(B) requires the producer of the molybdenum-99 

to accurately characterize, appropriately package, and transport 

the spent nuclear fuel and radioactive waste (for which there is no 

commercial disposal path) prior to acceptance by the Department. 

Subsection (c)(4)(A) requires the lease contracts to provide for 

compensation to be paid to the Department in cash for the low-enriched uranium leased under the contracts, the final disposal of the 

spent fuel and radioactive waste, and other costs of carrying out 

the program. It further provides that the compensation for the 

leased uranium be in amounts equal to prevailing market rates for 

the sale of comparable of uranium products, and that the compensation for final disposition and other costs be in amounts equal 

to the net present value of the cost to the Federal Government. 

Subparagraph (B) provides that the discount rate used to determine the net present value shall not be greater than the average 

interest rate on marketable Treasury securities. To be cost neutral, 

these securities should correspond to the period for final disposal 

of spent nuclear fuel and radioactive waste. 

Subsection (c)(5) authorizes the Secretary to obligate and expend 

funds received under the lease contracts without fiscal year limitation for activities in the Act, including those associated with final 

disposition of the spent nuclear fuel and radioactive waste. 

Subsection (c)(6) prohibits the use of bartering uranium for services of any kind associated with the lease contracts and final disposition of spent nuclear fuel and radioactive waste. 

Subsection (d) directs that the Department of Energy and the 

Nuclear Regulatory Commission, shall to the greatest extent practicable ensure that environmental reviews complement and not duplicate each other through the use of cooperating agencies or other 

regulatory mechanisms. 

Subsection (e) requires that the Secretary establish the lease contract program, including the ability to take spent nuclear fuel and 

radioactive waste under the lease contracts not later than 3 years 

after date of enactment. 

Subsection (f) allows radioactive material resulting from the production of medical isotopes to be classified as low-level radioactive 

waste if it meets federal requirements for disposal as low-level radioactive waste. 

Subsection (g) authorizes the appropriation of $5,000,000 to start 

up the program to take back the spent nuclear fuel and radioactive 

waste under subsection (c). 

Section 4 amends section 134 of the Atomic Energy Act of 1954, 

42 U.S.C. 2160d, by striking subsection (c), and by adding 5 new 

subsections designated (c) through (f). New subsection (c) prohibits 

the Nuclear Regulatory Commission from issuing a license for the 


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export of highly enriched uranium for medical isotope production 

effective 7 years after the date of enactment. 

New Atomic Energy Act section 134d. permits the 7-year period 

in subsection (c) 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. 

New section 134e. requires public notice and comment on the certification. 

New section 134f. 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. 

New section 134g. defines terms used in section 134 of the Atomic Energy Act of 1954. 

Section 5 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 used as targets of 

fuel in a nuclear research or test reactor. 

Section 6 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 

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 7 requires the Secretary to report to Congress one year 

after the date of enactment of S. 99, and annually for the ensuing 

5 years, on actions to support the production of molybdenum-99 for 

medical uses without the use of highly enriched uranium. 

Section 8 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 S. 99. 

Section 9 provides that the Chairman of the Budget Senate Committee shall determine and submit to the Congressional Record the 

budgetary affects of this Act under the ‘‘Pay-As-You-Go-Act of 

2010’’. 

COST AND BUDGETARY CONSIDERATIONS

The following estimate of costs of this measure has been provided 

by the Congressional Budget Office. 

S. 99—American Medical Isotopes Production Act of 2011 

Summary: S. 99 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 S. 99 would cost $150 


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million over the 2011–2016 period. CBO also estimates that enacting the legislation would affect direct spending; therefore, pay-asyou-go procedures apply. CBO estimates, however, that the net impact on direct spending would be negligible in any given year. Enacting S. 99 would not affect revenues. 

S. 99 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 S. 99 is shown in the following table. The costs of 

this legislation fall within budget function 270 (energy). 

By fiscal year, in millions of dollars— 

2012 2013 2014 2015 2016 2012– 

2016 

CHANGES IN SPENDING SUBJECT TO APPROPRIATION 

Estimated Authorization Level .......................................... 150 0 0 0 0 150 

Estimated Outlays ............................................................ 43 38 30 24 15 150 

Basis of estimate: For this estimate, CBO assumes that S. 99 will 

be enacted near the end of fiscal year 2011 and that authorized 

amounts will be provided near the start of 2012. 

CBO estimates that implementing S. 99 would require appropria- tions totaling $150 million for a program to support projects to 

produce molybdenum-99, a radioactive isotope produced from uranium, for use in certain medical procedures. In addition, the bill 

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

to retain financial responsibility for certain waste generated by the 

irradiation, processing, or purification of LEU. 

CBO estimates that implementing S. 99 would increase discre- tionary spending by $150 million over the 2012–2016 period. We 

also estimate that leasing LEU would have a negligible net impact 

on direct spending. 

Spending Subject to Appropriation 

S. 99 would specifically authorize appropriations totaling $143 

million to provide direct financial support for projects to produce 

molybdenum-99 and $5 million to establish a program to dispose 

of certain waste resulting from federal leases of LEU. In addition, 

CBO estimates that completing various studies, reports, and regulatory activities under the bill would require appropriations totaling $2 million over the 2012–2016 period. Assuming appropriation 

of the authorized and estimated amounts, CBO estimates that 

spending would total $150 million over the 2012–2016 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 S. 99 and takes into account historical spending 

patterns for similar activities. 

Under S. 99, the federal government would be responsible for 

disposing of certain types of waste generated by molybdenum-99 

producers who lease LEU from DOE. Spending related to waste 

generated under such leases would be subject to the availability of 

appropriated funds. Based on information from DOE about the volume of LEU that the agency anticipates would be leased under S. 


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99, CBO expects that resulting quantities of waste would be small. 

While waste disposal costs would be incurred over many years and 

could reach significant levels over time, CBO estimates that any increased costs over the 2012–2016 period would not exceed the $5 

million specifically authorized to be appropriated under the bill. 

Direct Spending 

S. 99 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 bill would otherwise generate offsetting receipts (a credit against direct spending) totaling 

about $1 million annually. Because S. 99 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 bill would be negligible in any 

given year. 

The bill also would require that the Secretary charge LEU lessees a fee to offset the net present value of DOE’s anticipated costs 

to dispose of certain types of waste generated from leased LEU, 

Under the bill DOE could spend those fees, without further appropriation, for activities related to waste disposal. Based on information from DOE about the range of potential costs the agency might 

face to dispose of waste pursuant to LEU leases, CBO estimates 

that any net change in direct spending resulting from the collection 

and spending of such fees would be negligible in any given year. 

Pay-As-You-Go considerations: The Statutory Pay-As-You-Go Act 

of 2010 establishes budget-reporting and enforcement procedures 

for legislation affecting direct spending or revenues. CBO estimates 

that enacting S. 99 would have a negligible net impact on direct 

spending in any given year, and would not have any impact on revenues. 

Intergovernmental and private-sector impact: S. 99 contains no 

intergovernmental or private-sector mandates as defined in UMRA 

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

Estimate prepared by: Federal Costs: Megan Carroll; Impact on 

State, Local, and Tribal Governments: Ryan Miller; Impact on the 

Private Sector: 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 

S. 99. 

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 S. 99. 


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CONGRESSIONALLY DIRECTED SPENDING

S. 99, 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 S. 99 on February 1, 2011, follows: 

DR. PARRISH STAPLES, DIRECTOR, OFFICE OF EUROPEAN

AND AFRICAN THREAT REDUCTION, GLOBAL THREAT RE- DUCTION INITIATIVE, DEFENSE NUCLEAR NONPROLIFERA- TION, 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) 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 nonHEU 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 


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states. New technical advances in Mo-99 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 nearterm 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 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 Mo99, and completed its first shipment of FDA-approved, 

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 proVerDate Mar 15 2010 06:11 May 19, 2011 Jkt 099010 PO 00000 Frm 00014 Fmt 6659 Sfmt 6969 E:\HR\OC\SR017.XXX SR017

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ducing Mo-99 consistent with international commitments 

to minimize and eliminate the use of HEU in isotope production. With appropriate Congressional support, the longterm 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 high-tech, 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 Molybdenum99 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 Mo99, 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, and 

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 linkVerDate Mar 15 2010 06:11 May 19, 2011 Jkt 099010 PO 00000 Frm 00015 Fmt 6659 Sfmt 6969 E:\HR\OC\SR017.XXX SR017

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age 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. 

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 S. 

99, 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 

AN ACT To amend the Atomic Energy Act of 1946, as amended, and for other 

purposes. 

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

United States of America in Congress assembled, That the Atomic 

Energy Act of 1946, as amended, is amended to read as follows: 

ATOMIC ENERGY ACT OF 1954 

TITLE I—ATOMIC ENERGY 

* * * * * * * 

CHAPTER 10. ATOMIC ENERGY LICENSES 

* * * * * * * 

Sec. 110. Exclusions. 

Sec. 112. Domestic medical isotope production. 

* * * * * * * 


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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, 

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; 

(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— 


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(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 

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. 

b. MEDICAL ISOTOPE PRODUCTION.— 

(1) DEFINITIONS.—In this subsection: 

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

(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. 

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

(i) contains byproduct material combined with chemical or biological material; and 

(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. 

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

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


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(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— 

(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 highly 

enriched uranium solely to produce medical isotopes; and 

(B) the highly enriched uranium for medical isotope production will be irradiated only in a reactor in a recipient 

country that— 

(i) uses an alternative nuclear reactor fuel; or 

(ii) is the subject of an 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. 

(3) REVIEW OF PHYSICAL PROTECTION REQUIREMENTS.— (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. 

(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. 

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

(i) the feasibility of procuring supplies of medical 

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

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

use; 

(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 

(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. 


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(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— 

(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; 

(ii) sufficient quantities of medical isotopes are 

available from low enriched uranium targets and fuel 

to meet United States domestic needs; and 

(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. 

(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— 

(i) contains the findings of the National Academy of 

Sciences made in the study under subparagraph (A); 

and 

(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. 

(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). 

(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. 

(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— 


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

c. 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. 

d. 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. 

e. 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. 

f. 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. 

g. 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; 


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(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 

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

* * * * * * * 

Æ 


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