[Senate Report 111-120]
[From the U.S. Government Publishing Office]


                                                       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
                  (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 procedures performed in the United States each year, 
which amounts to about 41,000 uses per day. Because of their 
short ``half-lives,'' 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 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.
    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 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 
molybdenum-99 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 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 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 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 
appropriations 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. 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 cannot be 
stockpiled. It must be produced on a continuous basis to meet 
the needs of the medical community, and any interruptions in 
production can place patients' health at risk if diagnostic 
tests cannot be performed. Currently, the United States depends 
entirely on foreign producers for all of its Mo-99, and these 
producers use highly enriched uranium (HEU) targets to produce 
this vital medical isotope.
    Historically, Mo-99 production processes have utilized the 
same form of HEU that can be used to produce nuclear weapons 
and nuclear explosive devices. Underscoring the global 
recognition of the grave threat posed by HEU falling into the 
wrong hands, including the risk of terrorists or rogue states 
acquiring such material, new technical advances in Mo-99 
production processes--just as in other civilian applications--
are demonstrating that HEU is no longer required. Provisions of 
this legislation, in particular Section 2, paragraph (11) are 
aligned with the NNSA's mission to convert or assist in the 
conversion of research reactors worldwide from the use of HEU-
based to LEU fuels and to convert medical isotope production 
from HEU to non-HEU based production.
    The American Medical Isotopes Production Act of 2009 under 
review by this committee would provide a long-term 
authorization to address this critical medical need by 
developing a domestic source of Mo-99 as well as furthering 
global HEU minimization efforts by ensuring that new domestic 
supplies of Mo-99 are non HEU-based. The proposed legislation 
will greatly promote the reliable supply of Mo-99 to hospitals 
throughout our country and will ultimately ensure the level of 
patient care that our citizens require.
    The Mo-99 shortages over the last few years are due to both 
unforeseen and required maintenance to the aging reactors 
around the world that provide the global supply. In May 2009, 
the fragile supply chain for Mo-99 was significantly threatened 
by the unexpected shutdown of the primary supplier for the U.S. 
due to a serious maintenance concern. In 2010, this unexpected 
supply interruption will be exacerbated by the required 
scheduled maintenance of the second largest global supplier. 
The Office of Science and Technology Policy of the Executive 
Office of the President is directing an Inter-agency working 
group, which includes NNSA and other Department of Energy 
offices, to investigate options to focus on near-term efforts 
to increase the supply to the U.S. during periods when the 
major suppliers will be out of operation, and prior to the 
development of new longer-term production capabilities. The 
current Mo-99 shortages are being mitigated as effectively as 
possible in the near-term through industry-wide communication, 
scheduling and more efficient use of available Mo-99 supplies, 
the application of alternate diagnostic technologies and 
increased production from all of the global producers. Near-
term production and the significant amount of attention focused 
to address this problem needs to be carefully balanced with 
other efforts to ensure the development of a long-term reliable 
supply of non-HEU based Mo-99. With appropriate Congressional 
support, the long-term options could be readily achievable and 
available for steady state production with the objective to 
create a consistent supply of the medical isotope to health 
care providers.
    The National Academies published a report on January 14, 
2009 confirming that the production of Mo-99 without the use of 
HEU is both technically and economically feasible. It was the 
National Academies' determination that there are ``no technical 
reasons that adequate quantities [of medical isotopes] cannot 
be produced'' without the use of HEU, and furthermore, that ``. 
. . the greatest single threat to supply reliability is the 
approaching obsolescence of the aging reactors that large-scale 
producers utilize to irradiate HEU target to obtain Mo-99.'' 
The report positively supports HEU minimization by establishing 
that it is feasible for global producers to convert to LEU, and 
identifying the risk to the domestic supply reliability.
    To address the longer-term production of Mo-99, NNSA is 
developing projects to accelerate the establishment of domestic 
commercial sources of Mo-99 without HEU. To prevent the single 
point of failure scenario facing today's U.S. Mo-99 supply, 
NNSA is helping demonstrate the feasibility of non-HEU based 
Mo-99 production by working with commercial entities and 
national laboratories on four technology pathways. These 
include: LEU fission technology; LEU solution reactor 
technology; neutron capture technology; and accelerator 
technology. The goal is for each technology to be commercially 
successful, and NNSA's approach is technology neutral. NNSA is 
working with the one commercial partner in each of the four 
areas whose projects on Mo-99 are most advanced for that 
technical pathway. NNSA also makes available the technical 
expertise of the U.S. national laboratories gained over many 
years in the non-HEU based Mo-99 production technologies. The 
commercialization of these different non-HEU based technologies 
supports the strategy to diversify the Mo-99 supply and move 
away from reliance on a sole technology and a limited number of 
facilities, as is the case with today's foreign producers.
    NNSA is planning to spend approximately $20 million in FY 
2010 to establish these technologies. Funding would come from 
within the Global Threat Reduction Initiative budget. As with 
any major technology initiative, there are challenges that 
could affect the acceleration of these technologies that must 
be addressed. We must overcome the technical difficulty 
involved in extracting the final medical product and processing 
it into a form that meets Food and Drug Administration (FDA) 
standards, and doing so steady-state on a commercial scale 
suitable to meet the needs of the medical community. The 
production of this valuable commodity is a complex endeavor and 
lessons learned from two experienced commercial-scale producers 
that have initiated recent projects to construct new production 
capabilities must be considered to minimize difficulties as we 
proceed. There are many research reactor operators globally 
that contend they can produce Mo-99, but we must not 
underestimate the difficulties to be overcome in the process to 
provide material at the standards required and on a scale to 
satisfy global demand. We must maintain our focus on supporting 
the demonstration of commercial scale Mo-99 production by those 
few specific entities that are most advanced under the 
technology-neutral process we have developed. We share the 
goals of this bill and look forward to working with you to 
ensure the accomplishment of nuclear threat reduction 
activities and the development of a reliable supply of medical 
isotopes to the public, while ensuring greater Presidential 
flexibility.
    This legislation will provide the national visibility 
necessary to address this critical medical need as rapidly as 
possible and will also achieve important nonproliferation 
goals. I thank Senator Bingaman and the Committee for your 
continued leadership by supporting this legislation.

                        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, 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 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.
          [(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 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.
          [(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.
                  [(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.
    [c. 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; and
          [(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.]
    (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 produce a radiopharmaceutical for 
        diagnostic, therapeutic procedures or for research and 
        development.

                                  
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