[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.