[Senate Report 112-17]
[From the U.S. Government Publishing Office]
Calendar No. 53
112th Congress Report
SENATE
1st Session 112-17
======================================================================
AMERICAN MEDICAL ISOTOPES PRODUCTION ACT
_______
May 18, 2011.--Ordered to be printed
_______
Mr. Bingaman, from the Committee on Energy and Natural Resources,
submitted the following
R E P O R T
[To accompany S. 99]
The Committee on Energy and Natural Resources, to which was
referred the bill (S. 99) to promote the production of
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 an
amendment and recommends that the bill, as amended, do pass.
The amendment is as follows:
Strike out all after the enacting clause and insert in lieu
thereof the following:
SECTION 1. SHORT TITLE.
This Act may be cited as the ``American Medical Isotopes Production
Act of 2011''.
SEC. 2. DEFINITIONS.
In this Act:
(1) Department.--The term ``Department'' means the Department
of Energy.
(2) Highly enriched uranium.--The term ``highly enriched
uranium'' means uranium enriched to 20 percent or greater in
the isotope U-235.
(3) Low enriched uranium.--The term ``low enriched uranium''
means uranium enriched to less than 20 percent in the isotope
U-235.
(4) Secretary.--The term ``Secretary'' means the Secretary of
Energy.
SEC. 3. IMPROVING THE RELIABILITY OF DOMESTIC MEDICAL ISOTOPE SUPPLY.
(a) Medical Isotope Development Projects.--
(1) In general.--The Secretary shall establish a technology-
neutral program--
(A) to evaluate and support projects for the
production in the United States, without the use of
highly enriched uranium, of significant quantities of
molybdenum-99 for medical uses;
(B) to be carried out in cooperation with non-Federal
entities; and
(C) the costs of which shall be shared in accordance
with section 988 of the Energy Policy Act of 2005 (42
U.S.C. 16352).
(2) Criteria.--Projects shall be judged against the following
primary criteria:
(A) The length of time necessary for the proposed
project to begin production of molybdenum-99 for
medical uses within the United States.
(B) The capability of the proposed project to produce
a significant percentage of United States demand for
molybdenum-99 for medical uses.
(C) The cost of the proposed project.
(3) Exemption.--An existing reactor in the United States
fueled with highly enriched uranium shall not be disqualified
from the program if the Secretary determines that--
(A) there is no alternative nuclear reactor fuel,
enriched in the isotope U-235 to less than 20 percent,
that can be used in that reactor;
(B) the reactor operator has provided assurances
that, whenever an alternative nuclear reactor fuel,
enriched in the isotope U-235 to less than 20 percent,
can be used in that reactor, it will use that
alternative in lieu of highly enriched uranium; and
(C) the reactor operator has provided a current
report on the status of its efforts to convert the
reactor to an alternative nuclear reactor fuel enriched
in the isotope U-235 to less than 20 percent, and an
anticipated schedule for completion of conversion.
(4) Public participation and review.--The Secretary shall--
(A) develop a program plan and annually update the
program plan through public workshops; and
(B) use the Nuclear Science Advisory Committee to
conduct annual reviews of the progress made in
achieving the program goals.
(5) Authorization of appropriations.--There are authorized to
be appropriated to the Secretary for carrying out the program
under paragraph (1) $143,000,000 for the period encompassing
fiscal years 2011 through 2014.
(b) Development Assistance.--The Secretary shall establish a program
to provide assistance for--
(1) the development of fuels, targets, and processes for
domestic molybdenum-99 production that do not use highly
enriched uranium; and
(2) commercial operations using the fuels, targets, and
processes described in paragraph (1).
(c) Uranium Lease and Take-back.--
(1) In general.--The Secretary shall establish a program to
make low-enriched uranium available, through lease contracts,
for irradiation for the production of molybdenum-99 for medical
uses.
(2) Title.--The lease contracts shall provide for the
producers of the molybdenum-99 to take title to and be
responsible for the molybdenum-99 created by the irradiation,
processing, or purification of uranium leased under this
section.
(3) Duties.--
(A) Secretary.--The lease contracts shall require the
Secretary--
(i) to retain responsibility for the final
disposition of spent nuclear fuel created by
the irradiation, processing, or purification of
uranium leased under this section for the
production of medical isotopes; and
(ii) to take title to and be responsible for
the final disposition of radioactive waste
created by the irradiation, processing, or
purification of uranium leased under this
section for which the Secretary determines the
producer does not have access to a disposal
path.
(B) Producer.--The producer of the spent nuclear fuel
and radioactive waste shall accurately characterize,
appropriately package, and transport the spent nuclear
fuel and radioactive waste prior to acceptance by the
Department.
(4) Compensation.--
(A) In general.--Subject to subparagraph (B), the
lease contracts shall provide for compensation in cash
amounts equivalent to prevailing market rates for the
sale of comparable uranium products and for
compensation in cash amounts equivalent to the net
present value of the cost to the Federal Government
for--
(i) the final disposition of spent nuclear
fuel and radioactive waste for which the
Department is responsible under paragraph (3);
and
(ii) other costs associated with carrying out
the uranium lease and take-back program
authorized by this subsection.
(B) Discount rate.--The discount rate used to
determine the net present value of costs described in
subparagraph (A)(ii) shall be not greater than the
average interest rate on marketable Treasury
securities.
(5) Authorized use of funds.--The Secretary may obligate and
expend funds received under leases entered into under this
subsection, which shall remain available until expended, for
the purpose of carrying out the activities authorized by this
Act, including activities related to the final disposition of
spent nuclear fuel and radioactive waste for which the
Department is responsible under paragraph (3).
(6) Exchange of uranium for services.--The Secretary shall
not barter or otherwise sell or transfer uranium in any form in
exchange for--
(A) services related to the final disposition of the
spent nuclear fuel and radioactive waste for which the
Department is responsible under paragraph (3); or
(B) any other services associated with carrying out
the uranium lease and take-back program authorized by
this subsection.
(d) Coordination of Environmental Reviews.--The Department and the
Nuclear Regulatory Commission shall ensure to the maximum extent
practicable that environmental reviews for the production of the
medical isotopes shall complement and not duplicate each review.
(e) Operational Date.--The Secretary shall establish a program as
described in subsection (c)(3) not later than 3 years after the date of
enactment of this Act.
(f) Radioactive Waste.--Notwithstanding section 2 of the Nuclear
Waste Policy Act of 1982 (42 U.S.C. 10101), radioactive material
resulting from the production of medical isotopes that has been
permanently removed from a reactor or subcritical assembly and for
which there is no further use shall be considered low-level radioactive
waste if the material is acceptable under Federal requirements for
disposal as low-level radioactive waste.
(g) Authorization of Appropriations.--There are authorized to be
appropriated to the Secretary $5,000,000 for the establishment of a
program for the final disposition of spent nuclear fuel and radioactive
waste for which the Department is responsible under subsection (c).
SEC. 4. EXPORTS.
Section 134 of the Atomic Energy Act of 1954 (42 U.S.C. 2160d) is
amended by striking subsection c. and inserting the following:
``c. Effective 7 years after the date of enactment of the American
Medical Isotopes Production Act of 2011, the Commission may not issue a
license for the export of highly enriched uranium from the United
States for the purposes of medical isotope production.
``d. The period referred to in subsection b. may be extended for no
more than 6 years if, no earlier than 6 years after the date of
enactment of the American Medical Isotopes Production Act of 2011, the
Secretary of Energy certifies to the Committee on Energy and Commerce
of the House of Representatives and the Committee on Energy and Natural
Resources of the Senate that--
``(1) there is insufficient global supply of molybdenum-99
produced without the use of highly enriched uranium available
to satisfy the domestic United States market; and
``(2) the export of United States-origin highly enriched
uranium for the purposes of medical isotope production is the
most effective temporary means to increase the supply of
molybdenum-99 to the domestic United States market.
``e. To ensure public review and comment, the development of the
certification described in subsection c. shall be carried out through
announcement in the Federal Register.
``f. At any time after the restriction of export licenses provided
for in subsection b. becomes effective, if there is a critical shortage
in the supply of molybdenum-99 available to satisfy the domestic United
States medical isotope needs, the restriction of export licenses may be
suspended for a period of no more than 12 months, if--
``(1) the Secretary of Energy certifies to the Congress that
the export of United States-origin highly enriched uranium for
the purposes of medical isotope production is the only
effective temporary means to increase the supply of molybdenum-
99 necessary to meet United States medical isotope needs during
that period; and
``(2) the Congress enacts a Joint Resolution approving the
temporary suspension of the restriction of export licenses.
``g. As used in this section--
``(1) the term `alternative nuclear reactor fuel or target'
means a nuclear reactor fuel or target which is enriched to
less than 20 percent in the isotope 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 medical
isotope production to be conducted in the reactor
without a large percentage increase in the total cost
of operating the reactor; and
``(4) the term `medical isotope' includes molybdenum-99,
iodine-131, xenon-133, and other radioactive materials used to
produce a radiopharmaceutical for diagnostic or therapeutic
procedures or for research and development.''.
SEC. 5. REPORT ON DISPOSITION OF EXPORTS.
Not later than 1 year after the date of the enactment of this Act,
the Chairman of the Nuclear Regulatory Commission, after consulting
with other relevant agencies, shall submit to the Congress a report
detailing the current disposition of previous United States exports of
highly enriched uranium used as fuel or targets in a nuclear research
or test reactor, including--
(1) their location;
(2) whether they are irradiated;
(3) whether they have been used for the purpose stated in
their export license;
(4) whether they have been used for an alternative purpose
and, if so, whether such alternative purpose has been
explicitly approved by the Commission;
(5) the year of export, and reimportation, if applicable;
(6) their current physical and chemical forms; and
(7) whether they are being stored in a manner which
adequately protects against theft and unauthorized access.
SEC. 6. DOMESTIC MEDICAL ISOTOPE PRODUCTION.
(a) In General.--Chapter 10 of the Atomic Energy Act of 1954 (42
U.S.C. 2131 et seq.) is amended by adding at the end the following:
``Sec. 112. Domestic Medical Isotope Production.-- a. The Commission
may issue a license, or grant an amendment to an existing license, for
the use in the United States of highly enriched uranium as a target for
medical isotope production in a nuclear reactor, only if, in addition
to any other requirement of this Act--
``(1) the Commission determines that--
``(A) there is no alternative medical isotope
production target, enriched in the isotope U-235 to
less than 20 percent, that can be used in that reactor;
and
``(B) the proposed recipient of the medical isotope
production target has provided assurances that,
whenever an alternative medical isotope production
target can be used in that reactor, it will use that
alternative in lieu of highly enriched uranium; and
``(2) the Secretary of Energy has certified that the United
States Government is actively supporting the development of an
alternative medical isotope production target that can be used
in that reactor.
``b. As used in this section--
``(1) the term `alternative medical isotope production
target' means a nuclear reactor target which is enriched to
less than 20 percent of the isotope U-235;
``(2) a target `can be used' in a nuclear research or test
reactor if--
``(A) the target has been qualified by the Reduced
Enrichment Research and Test Reactor Program of the
Department of Energy; and
``(B) use of the target will permit the large
majority of ongoing and planned experiments and medical
isotope production to be conducted in the reactor
without a large percentage increase in the total cost
of operating the reactor;
``(3) the term `highly enriched uranium' means uranium
enriched to 20 percent or more in the isotope U-235; and
``(4) the term `medical isotope' includes molybdenum-99,
iodine-131, xenon-133, and other radioactive materials used to
produce a radiopharmaceutical for diagnostic or therapeutic
procedures or for research and development.''.
(b) Table of Contents.--The table of contents for the Atomic Energy
Act of 1954 is amended by inserting the following new item at the end
of the items relating to chapter 10 of title I:
``Sec. 112. Domestic medical isotope production.''.
SEC. 7. ANNUAL DEPARTMENT REPORTS.
(a) In General.--Not later than 1 year after the date of enactment of
this Act, and annually thereafter for 5 years, the Secretary shall
report to Congress on Department actions to support the production in
the United States, without the use of highly enriched uranium, of
molybdenum-99 for medical uses.
(b) Contents.--The reports shall include the following:
(1) For medical isotope development projects--
(A) the names of any recipients of Department support
under section 3;
(B) the amount of Department funding committed to
each project;
(C) the milestones expected to be reached for each
project during the year for which support is provided;
(D) how each project is expected to support the
increased production of molybdenum-99 for medical uses;
(E) the findings of the evaluation of projects under
section 3(a)(2); and
(F) the ultimate use of any Department funds used to
support projects under section 3.
(2) A description of actions taken in the previous year by
the Secretary to ensure the safe disposition of spent nuclear
fuel and radioactive waste for which the Department is
responsible under section 3(c).
SEC. 8. NATIONAL ACADEMY OF SCIENCES REPORT.
(a) In General.--The Secretary shall enter into an arrangement with
the National Academy of Sciences to conduct a study of the state of
molybdenum-99 production and utilization, to be provided to Congress
not later than 5 years after the date of enactment of this Act.
(b) Contents.--The report shall include the following:
(1) For molybdenum-99 production--
(A) a list of all facilities in the world producing
molybdenum-99 for medical uses, including an indication
of whether these facilities use highly enriched uranium
in any way;
(B) a review of international production of
molybdenum-99 over the previous 5 years, including--
(i) whether any new production was brought
online;
(ii) whether any facilities halted production
unexpectedly; and
(iii) whether any facilities used for
production were decommissioned or otherwise
permanently removed from service; and
(C) an assessment of progress made in the previous 5
years toward establishing domestic production of
molybdenum-99 for medical uses, including the extent to
which other medical isotopes that have been produced
with molybdenum-99, such as iodine-131 and xenon-133,
are being used for medical purposes.
(2) An assessment of the progress made by the Department and
others to eliminate all worldwide use of highly enriched
uranium in reactor fuel, reactor targets, and medical isotope
production facilities.
SEC. 9. BUDGETARY EFFECTS.
The budgetary effects of this Act, for the purpose of complying with
the Statutory Pay-As-You-Go-Act of 2010, shall be determined by
reference to the latest statement titled ``Budgetary Effects of PAYGO
Legislation'' for this Act, submitted for printing in the Congressional
Record by the Chairman of the Senate Budget Committee, provided that
such statement has been submitted prior to the vote on passage.
Purpose
The purpose of S. 99 is to promote the domestic production
of molybdenum-99 for medical isotope production and to
condition and phase out the export of highly enriched uranium
for the production of medical isotopes.
Background and Need
Molybdenum-99 and its decay product, technetium-99m, are
the workhorses of nuclear medicine. Currently, molybdenum-99 is
produced by irradiating a uranium-235 target in a nuclear
reactor, which causes the uranium-235 atoms to split into
molybdenum-99 and other fission products. Molybdenum-99 is then
chemically separated from the other fission products, collected
in small cylinders known as technetium generators, and shipped
to radiopharmacies and hospitals.
Molybdenum-99 is unstable. Half of any given amount decays
in about 66 hours, producing technetium-99m. Technetium-99m is
recovered from the generator and used in medical diagnostic
imaging of the brain, kidney, heart, bone, liver, and lung.
Technetium-99m, like molybdenum-99 is unstable; half of any
given amount decays in about 6 hours. A technetium generator
only lasts about 6 days.
The production of molybdenum-99 and technetium-99m are
extremely important to the detection and treatment of disease.
Technetium-99m is used in two-thirds of the 16 million nuclear
medical procedures performed in the United States each year,
which amounts to about 41,000 uses per day. Because of their
short ``half-lives,'' neither molybdenum-99 nor technetium-99m
can be stockpiled. They must be produced on an ongoing and
reliable basis to ensure constant availability for necessary
medical procedures.
The United States consumes approximately half of the
world's supply of molybdenum-99, but since 1989 has had no
domestic source of supply. Between 95 and 98 percent of the
world's molybdenum-99 is produced by four companies in Canada,
Belgium, the Netherlands, and South Africa. The United States
is dependent on two of these companies: MDS Nordion, which is
based in Canada, historically supplies about 60 percent of our
needs; and Mallinckrodt, which is based in the Netherlands and
supplies the rest.
Because the United States is 100 percent dependent upon
foreign sources for these medical isotopes, any delay in their
production could cause a shortage of molybdenum-99 and
technetium-99m. For example, the Canadian reactor that produces
molybdenum-99 was shut down between May 2009 and the fall of
2010. The Netherlands reactor was also shut down for repairs
between February and the fall of 2010. The result of the outage
of these two aging reactors was that there were days during the
summer of 2010 when U.S. patients could not receive technetium-
99m, thus forgoing important diagnostic procedures. These
reactors are expected to shut down in 2016, thus exacerbating
the shortage of technetium-99m to U.S. patients for the
foreseeable future.
In addition to the current supply concerns, molybdenum-99
production has long posed nuclear proliferation concerns. All
four of the companies that are responsible for 95 to 98 percent
of the world's production use highly enriched uranium targets
to produce molybdenum-99. The United States is the world's
primary supplier of the highly enriched uranium used for
molybdenum-99 production. Highly enriched uranium, if obtained
by terrorists or a rogue state, could be used to produce a
nuclear weapon.
As a result of the nuclear proliferation concern, the
Energy Policy Act of 1992 amended the Atomic Energy Act of 1954
to restrict the export of highly enriched uranium. The Energy
Policy Act of 2005 subsequently relaxed this restriction to
permit exports to certain countries to continue for medical
isotope production. In addition, the Energy Policy Act of 2005
asked the National Academy of Sciences to determine if it is
feasible to obtain medical isotopes from sources using low
enriched uranium targets.
The National Academy of Sciences published its report,
Medical Isotope Production Without Highly Enriched Uranium, in
January 2009. The Academy found that although, at present,
sufficient quantities of medical isotopes to meet our domestic
needs cannot be produced without highly enriched uranium, there
is no technical reason that adequate quantities could not be
produced using low enriched uranium targets. It noted that
Argentina and Australia are already producing molybdenum-99
with low enriched uranium targets, though in relatively small
quantities sufficient only to meet their regional needs. It
also found that use of highly enriched uranium targets could be
phased out and replaced by low enriched uranium targets in 7 to
10 years. This conclusion was further bolstered by the November
2009 Report of the Export Review Panel to Canada's Minister of
Natural Resources, which recommended that any new reactor-based
source of molybdenum-99 use low enriched uranium.
S. 99 is needed to help facilitate the development of a
stable domestic supply of molybdenum-99, as well as the
conversion of medical isotope production from the use of highly
enriched to low enriched uranium both by directing the
Secretary of Energy to establish a technology neutral program
to support the production of molybdenum-99 without the use of
highly enriched uranium and by phasing out the export of highly
enriched uranium.
Legislative History
S. 99 was introduced by Senator Bingaman on January 25,
2011. Senator Murkowski was an original cosponsor. As
introduced, S. 99 was identical to H.R. 3276, as reported by
the Committee on Energy and Natural Resources, in the 111th
Congress. H.R. 3276 was introduced by Representative Markey on
July 21, 2009, was reported by the Committee on Energy and
Commerce on November 4, 2009 (H. Rept. 111-328), and passed the
House on November 5, 2009 by a vote of 400 to 17.
The Committee on Energy and Natural Resources held a
hearing on H.R. 3276 on December 3, 2009 (S. Hrg. 111-314), and
ordered it favorably reported, with amendments, on December 16,
2009. (S. Rept. 111-120.)
The Committee held a hearing on S. 99 on February 1, 2011
(S. Hrg. 112-4), and ordered it favorably reported, with an
amendment in the nature of a substitute, on April 12, 2011.
Committee Recommendation
The Senate Committee on Energy and Natural Resources, in
open business session on April 12, 2011, by a voice vote of a
quorum present recommends that the Senate pass S. 99, if
amended as described herein.
Committee Amendments
During its consideration of S. 99, the Committee adopted an
amendment in the nature of a substitute. The amendment makes a
number of changes in the bill as introduced.
New definitions for the terms ``Department'' and
``Secretary'' are added to the definition section, which is
moved to the beginning of the bill and redesignated ``section
2'' instead of ``section 8.''
The exemption in section 3(a)(3) (formerly section
2(a)(3)), which permits existing reactors fueled with highly
enriched uranium to participate in the development program, is
restricted to reactors in the United States.
The uranium lease and take-back program in section 3(c)
(formerly section 4(c)) is clarified by providing that the
producers will take title to the molybdenum-99, the Secretary
will take title to the spent nuclear fuel and radioactive
wastes for which the producers do not have access to a disposal
path, and the producers will characterize, package, and
transport the spent nuclear fuel and radioactive waste prior to
acceptance by the Department. Former section 4(c) is further
modified to require producers to compensate the Department for
costs associated with the lease and take-back program (in the
new section 3(c)(4)), to authorize the Secretary to spend funds
received under the leases to carry out the program, including
the disposal of radioactive waste for which the Department is
responsible under the lease contracts (in section 3(c)(5)), and
to clarify the restrictions on exchanging of uranium for
services (in section 3(c)(6)).
New subsections are added to require the Department and the
Nuclear Regulatory Commission to coordinate environmental
reviews for medical isotope production (section 3(d)), to
require the Secretary to make the program to take back spent
nuclear fuel and radioactive wastes operational within 3 years
of the date of enactment (section 3(e)), to allow radioactive
material resulting from the production of medical isotopes for
which there is no further use to be treated as low-level
radioactive waste if it meets federal requirements for disposal
as low-level radioactive waste (section 3(f)), and to authorize
appropriation of $5 million to establish the program to take
back spent nuclear fuel and radioactive waste.
Section 4 (formerly section 3) is modified to strike only
section 134c. (and not section 134b.) of the Atomic Energy Act
of 1954.
Section 5 (formerly section 4) is modified to require the
Nuclear Regulatory Commission to report on the exports of
highly enriched uranium used as fuel or isotope targets, rather
than on all highly enriched uranium exports.
Section-by-Section Analysis
Section 1 provides a short title.
Section 2 defines terms used throughout the Act.
Section 3(a)(1) directs the Secretary of Energy (the
Secretary) to establish a technology-neutral, cost-shared
program to evaluate and support projects for the production of
molybdenum-99 for medical uses without the use of highly
enriched uranium.
Subsection (a)(2) provides criteria for evaluating
projects.
Subsection (a)(3) permits existing U.S. reactors fueled
with highly enriched uranium to participate in the program
under specified conditions.
Subsection (a)(4) requires the Secretary to develop and
update a program plan through public workshops, and to use the
Nuclear Science Advisory Committee to review program progress.
Subsection (a)(5) authorizes $143 million to be
appropriated to the Secretary for fiscal years 2011 through
2014 to carry out the program.
Subsection (b) directs the Secretary to establish a program
to provide assistance for the development of fuels, targets,
and processes for production of molybdenum-99 without the use
of highly enriched uranium, and for commercial operations using
such fuels, targets, and processes.
Subsection (c)(1) directs the Secretary to establish a
program to supply, through lease contracts, low enriched
uranium for use in the production of molybdenum-99 for medical
uses.
Subsection (c)(2) requires that the lease contracts provide
for the producers of molybdenum-99 to take title to and be
responsible for the molybdenum-99 derived from the low enriched
uranium.
Subsection (c)(3)(A) requires the Secretary to be
responsible for the final disposition of the spent nuclear fuel
from the lease contracts and to take title to and be
responsible for the waste created through the irradiation,
processing, or purification of the low enriched uranium from
the lease contracts for which the Secretary determines that the
producer of the molybdenum-99 does not have a commercially
available disposal path.
Subsection (c)(3)(B) requires the producer of the
molybdenum-99 to accurately characterize, appropriately
package, and transport the spent nuclear fuel and radioactive
waste (for which there is no commercial disposal path) prior to
acceptance by the Department.
Subsection (c)(4)(A) requires the lease contracts to
provide for compensation to be paid to the Department in cash
for the low-enriched uranium leased under the contracts, the
final disposal of the spent fuel and radioactive waste, and
other costs of carrying out the program. It further provides
that the compensation for the leased uranium be in amounts
equal to prevailing market rates for the sale of comparable of
uranium products, and that the compensation for final
disposition and other costs be in amounts equal to the net
present value of the cost to the Federal Government.
Subparagraph (B) provides that the discount rate used to
determine the net present value shall not be greater than the
average interest rate on marketable Treasury securities. To be
cost neutral, these securities should correspond to the period
for final disposal of spent nuclear fuel and radioactive waste.
Subsection (c)(5) authorizes the Secretary to obligate and
expend funds received under the lease contracts without fiscal
year limitation for activities in the Act, including those
associated with final disposition of the spent nuclear fuel and
radioactive waste.
Subsection (c)(6) prohibits the use of bartering uranium
for services of any kind associated with the lease contracts
and final disposition of spent nuclear fuel and radioactive
waste.
Subsection (d) directs that the Department of Energy and
the Nuclear Regulatory Commission, shall to the greatest extent
practicable ensure that environmental reviews complement and
not duplicate each other through the use of cooperating
agencies or other regulatory mechanisms.
Subsection (e) requires that the Secretary establish the
lease contract program, including the ability to take spent
nuclear fuel and radioactive waste under the lease contracts
not later than 3 years after date of enactment.
Subsection (f) allows radioactive material resulting from
the production of medical isotopes to be classified as low-
level radioactive waste if it meets federal requirements for
disposal as low-level radioactive waste.
Subsection (g) authorizes the appropriation of $5,000,000
to start up the program to take back the spent nuclear fuel and
radioactive waste under subsection (c).
Section 4 amends section 134 of the Atomic Energy Act of
1954, 42 U.S.C. 2160d, by striking subsection (c), and by
adding 5 new subsections designated (c) through (f). New
subsection (c) prohibits the Nuclear Regulatory Commission from
issuing a license for the export of highly enriched uranium for
medical isotope production effective 7 years after the date of
enactment.
New Atomic Energy Act section 134d. permits the 7-year
period in subsection (c) to be extended for up to 6 additional
years if the Secretary certifies that there is insufficient
global supply of molybdenum-99 produced without the use of
highly enriched uranium to satisfy the domestic market and that
the export of highly enriched uranium is the most effective
temporary means to increase the domestic supply of molybdenum-
99.
New section 134e. requires public notice and comment on the
certification.
New section 134f. provides for the suspension, for up to 12
months, of the prohibition on the export licensing of highly
enriched uranium after it has become effective if there is a
critical shortage of molybdenum-99, the Secretary certifies
that the export of highly enriched uranium is the only
effective temporary means to increase the supply, and Congress
enacts a joint resolution approving the temporary suspension.
New section 134g. defines terms used in section 134 of the
Atomic Energy Act of 1954.
Section 5 requires the Chairman of the Nuclear Regulatory
Commission to submit to Congress a report on the current
disposition of previous exports of highly enriched uranium used
as targets of fuel in a nuclear research or test reactor.
Section 6 adds a new section 112 to the Atomic Energy Act
of 1954 to authorize the Nuclear Regulatory Commission to
license the use in the United States of highly enriched uranium
as a target for medical isotope production only if, in addition
to other requirements of the Atomic Energy Act, the Commission
determines that no low enriched uranium target can be used in
the reactor, and the recipient has provided assurances that if
a low enriched uranium target can be used, it will be, and the
Secretary certifies that the United States Government is
actively supporting the development of low enriched uranium
targets for the reactor.
Section 7 requires the Secretary to report to Congress one
year after the date of enactment of S. 99, and annually for the
ensuing 5 years, on actions to support the production of
molybdenum-99 for medical uses without the use of highly
enriched uranium.
Section 8 requires the National Academy of Sciences to
study the state of molybdenum-99 production and use not later
than 5 years after the date of enactment of S. 99.
Section 9 provides that the Chairman of the Budget Senate
Committee shall determine and submit to the Congressional
Record the budgetary affects of this Act under the ``Pay-As-
You-Go-Act of 2010''.
Cost and Budgetary Considerations
The following estimate of costs of this measure has been
provided by the Congressional Budget Office.
S. 99--American Medical Isotopes Production Act of 2011
Summary: S. 99 would authorize funding to support projects
to produce molybdenum-99, a radioactive isotope used in certain
medical procedures. Assuming appropriation of the authorized
amounts, CBO estimates that implementing S. 99 would cost $150
million over the 2011-2016 period. CBO also estimates that
enacting the legislation would affect direct spending;
therefore, pay-as-you-go procedures apply. CBO estimates,
however, that the net impact on direct spending would be
negligible in any given year. Enacting S. 99 would not affect
revenues.
S. 99 contains no intergovernmental or private-sector
mandates as defined in the Unfunded Mandates Reform Act (UMRA)
and would impose no costs on state, local, or tribal
governments.
Estimated cost to the Federal Government: The estimated
budgetary impact of S. 99 is shown in the following table. The
costs of this legislation fall within budget function 270
(energy).
----------------------------------------------------------------------------------------------------------------
By fiscal year, in millions of dollars--
------------------------------------------------------------
2012 2013 2014 2015 2016 2012-2016
----------------------------------------------------------------------------------------------------------------
CHANGES IN SPENDING SUBJECT TO APPROPRIATION
Estimated Authorization Level...................... 150 0 0 0 0 150
Estimated Outlays.................................. 43 38 30 24 15 150
----------------------------------------------------------------------------------------------------------------
Basis of estimate: For this estimate, CBO assumes that S.
99 will be enacted near the end of fiscal year 2011 and that
authorized amounts will be provided near the start of 2012.
CBO estimates that implementing S. 99 would require
appropriations totaling $150 million for a program to support
projects to produce molybdenum-99, a radioactive isotope
produced from uranium, for use in certain medical procedures.
In addition, the bill would direct the Secretary of Energy to
make low-enriched uranium (LEU) available through lease
contracts to producers of molybdenum-99. Such lease contracts
would provide for the Secretary to retain financial
responsibility for certain waste generated by the irradiation,
processing, or purification of LEU.
CBO estimates that implementing S. 99 would increase
discretionary spending by $150 million over the 2012-2016
period. We also estimate that leasing LEU would have a
negligible net impact on direct spending.
Spending Subject to Appropriation
S. 99 would specifically authorize appropriations totaling
$143 million to provide direct financial support for projects
to produce molybdenum-99 and $5 million to establish a program
to dispose of certain waste resulting from federal leases of
LEU. In addition, CBO estimates that completing various
studies, reports, and regulatory activities under the bill
would require appropriations totaling $2 million over the 2012-
2016 period. Assuming appropriation of the authorized and
estimated amounts, CBO estimates that spending would total $150
million over the 2012-2016 period. That estimate is based on
information from the Department of Energy (DOE) about the types
of molybdenum-99 projects that might be supported under S. 99
and takes into account historical spending patterns for similar
activities.
Under S. 99, the federal government would be responsible
for disposing of certain types of waste generated by
molybdenum-99 producers who lease LEU from DOE. Spending
related to waste generated under such leases would be subject
to the availability of appropriated funds. Based on information
from DOE about the volume of LEU that the agency anticipates
would be leased under S. 99, CBO expects that resulting
quantities of waste would be small. While waste disposal costs
would be incurred over many years and could reach significant
levels over time, CBO estimates that any increased costs over
the 2012-2016 period would not exceed the $5 million
specifically authorized to be appropriated under the bill.
Direct Spending
S. 99 would direct the Secretary to lease LEU to producers
of molybdenum-99. Under current law, CBO estimates that sales
of the material that would be leased under the bill would
otherwise generate offsetting receipts (a credit against direct
spending) totaling about $1 million annually. Because S. 99
would require that lessees pay fees equivalent to the
prevailing market rates for the sale of comparable uranium
products, CBO estimates that any differences in receipts
generated under the bill would be negligible in any given year.
The bill also would require that the Secretary charge LEU
lessees a fee to offset the net present value of DOE's
anticipated costs to dispose of certain types of waste
generated from leased LEU, Under the bill DOE could spend those
fees, without further appropriation, for activities related to
waste disposal. Based on information from DOE about the range
of potential costs the agency might face to dispose of waste
pursuant to LEU leases, CBO estimates that any net change in
direct spending resulting from the collection and spending of
such fees would be negligible in any given year.
Pay-As-You-Go considerations: The Statutory Pay-As-You-Go
Act of 2010 establishes budget-reporting and enforcement
procedures for legislation affecting direct spending or
revenues. CBO estimates that enacting S. 99 would have a
negligible net impact on direct spending in any given year, and
would not have any impact on revenues.
Intergovernmental and private-sector impact: S. 99 contains
no intergovernmental or private-sector mandates as defined in
UMRA and would impose no costs on state, local, or tribal
governments.
Estimate prepared by: Federal Costs: Megan Carroll; Impact
on State, Local, and Tribal Governments: Ryan Miller; Impact on
the Private Sector: Amy Petz.
Estimate approved by: Theresa Gullo, Deputy Assistant
Director for Budget Analysis.
Regulatory Impact Evaluation
In compliance with paragraph 11(b) of rule XXVI of the
Standing Rules of the Senate, the Committee makes the following
evaluation of the regulatory impact which would be incurred in
carrying out S. 99.
The bill is not a regulatory measure in the sense of
imposing Government established standards or significant
economic responsibilities on private individuals and
businesses.
No personal information would be collected in administering
the program. Therefore, there would be no impact on personal
privacy.
Little, if any, additional paperwork would result from the
enactment of S. 99.
Congressionally Directed Spending
S. 99, as reported, does not contain congressionally
directed spending items, limited tax benefits, or limited
tariff benefits as defined in rule XLIV of the Standing Rules
of the Senate.
Executive Communications
The testimony of the National Nuclear Security
Administration at the Committee's hearing on S. 99 on February
1, 2011, follows:
Dr. Parrish Staples, Director, Office of European and African Threat
Reduction, Global Threat Reduction Initiative, Defense Nuclear
Nonproliferation, National Nuclear Security Administration, Department
of Energy
Chairman Bingaman, Ranking Member Murkowski, and Committee
Members, thank you for the opportunity to testify about the
National Nuclear Security Administration's (NNSA's) support for
accelerating development of a domestic commercial supply of
Molybdenum-99 (Mo-99) without using highly enriched uranium
(HEU). This effort is part of our larger global
nonproliferation program to minimize and, where possible,
eliminate the use of HEU in civilian nuclear applications,
including in the production of medical radioisotopes. My
testimony will update you on testimony provided to this
committee in December 2009 about (1) the nonproliferation and
medical benefits of S.99, the American Medical Isotopes
Production Act of 2011; (2) the NNSA's progress to accelerate
the establishment of a non-HEU based domestic commercial supply
of Mo-99; and (3) changing global market conditions that could
undermine our efforts for a reliable domestic production of
non-HEU-based Mo-99.
Mo-99 is the parent isotope of Technetium-99m, which is
used in approximately 50,000 diagnostic medical procedures
every day in the United States. It has a very short half life
and therefore must be produced on a continuous basis to meet
the needs of the medical community. Any interruptions in
production can place patients at risk if diagnostic tests
cannot be performed.
Currently, the United States depends entirely on foreign
producers for all of its Mo-99. Of the major international
suppliers of commercial Mo-99, Canada, the Netherlands, and
Belgium use HEU targets to produce this vital medical isotope.
Only South Africa, which partnered with NNSA to convert its HEU
reactor to low enriched uranium (LEU) fuel, has begun LEU-based
Mo-99 production.
Mo-99 production processes based on HEU utilize nuclear
material enriched to the same degree as nuclear material used
to produce nuclear weapons and improvised nuclear devices.
World leaders at the 2010 Nuclear Security Summit and other
fora underscored the need to minimize and, where possible,
eliminate the use of HEU due to the grave threats posed by
excess nuclear materials and the possible acquisition of such
materials by terrorists or rogue states. New technical advances
in Mo-99 production processes, many of which have been
supported by the U.S. Department of Energy and NNSA working
closely with industry and our national laboratories, are
demonstrating that HEU is no longer required. S. 99, the
American Medical Isotopes Production Act of 2011 will encourage
Mo-99 suppliers worldwide not to use HEU and to develop a
reliable supply of Mo-99 for the U.S. medical community.
Provisions of this legislation, in particular Section 5, are
aligned with the NNSA's nonproliferation mission to assist in
the conversion of research reactors and isotope production
facilities worldwide from the use of HEU to LEU, and to
establish a reliable supply of Mo-99 produced without the use
of HEU in the United States.
Furthermore, the HEU-free, U.S.-based Mo-99 production
encouraged by the American Medical Isotopes Production Act of
2011 would serve as an example for eliminating HEU in the
global medical isotope business. The proposed legislation will
promote the reliable supply of Mo-99 to hospitals throughout
our country and will ultimately ensure the level of patient
care that our citizens require in a way that is consistent with
our nuclear nonproliferation goals.
As has been the case in 2009-2010, global Mo-99 shortages
can occur with any change in the production schedules of the
major producers. Unforeseen shutdowns due to technical problems
or scheduled maintenance of the aging reactors currently
producing Mo-99 can threaten the fragile supply chain for the
much needed medical isotopes. Under the leadership of the
Office of Science and Technology Policy of the Executive Office
of the President, an Interagency working group, which includes
NNSA and other Department of Energy offices, is pursuing the
following actions: (1) investigating options to focus on near-
term efforts to increase the supply to the U.S. during periods
when the major suppliers will be out of operation; (2)
coordinating efforts to maximize the success of the commercial
sector to develop new longer-term production capabilities for
the U.S. medical community; and (3) working with
representatives of the medical community to ensure
communication about the timing of scheduled maintenance to more
efficiently manage use of available Mo-99 supplies.
NNSA frequently meets with the existing major global Mo-99
producers as part of its nuclear nonproliferation agenda to
promote the development of a long-term reliable supply of Mo-99
using LEU. NNSA's programs can also assist other countries with
conversion, where possible. For example, with NNSA's support,
the South African Nuclear Energy Corporation (Necsa) became the
first major supplier to produce large-scale quantities of LEU-
based Mo-99, and completed its first shipment of FDA-approved,
LEU-based Mo-99 to the United States in December 2010. Necsa's
achievement to produce large-scale quantities of LEU-based Mo-
99 is an important nonproliferation advance as it demonstrates
the technical viability of producing Mo-99 consistent with
international commitments to minimize and eliminate the use of
HEU in isotope production. With appropriate Congressional
support, the long-term goal of steady state production from LEU
could be achieved globally, and could thus provide a
complementary, consistent supply of the medical isotope to
health care providers.
The 2009 National Academies report confirmed that
production of Mo-99 is both technically and economically
feasible, and as a result, NNSA is demonstrating the
feasibility of non-HEU based Mo-99 production by working with
four commercial entities to develop technology pathways to
produce adequate quantities of Mo-99 for the United States.
These include: LEU solution reactor technology; neutron capture
technology; and accelerator technology. The strategy is to move
away from reliance on a sole technology and a limited number of
facilities, as is the case with the global Mo-99 market today.
The goal is for each technology to be commercially successful,
and therefore NNSA's approach is technology neutral. NNSA also
makes available to these commercial partners the technical
expertise of the U.S. national laboratories gained from their
many years of work to develop non-HEU based Mo-99 production
technologies. We share the goals of this bill and look forward
to working with you to ensure the accomplishment of nuclear
threat reduction activities and the development of a reliable
supply of medical isotopes to the public, while ensuring
greater Presidential flexibility.
Despite the good progress, challenges remain that could
obstruct the successful and accelerated establishment of a
domestic supply of Mo-99. First, the major global producers
have been and continue to be heavily subsidized by their
governments. Such subsidies put at risk the economic viability
of U.S. companies starting up high-tech, capital intensive
businesses to produce non-HEU based Mo-99. A 2010 independent
economic study by the Organization for Economic Cooperation and
Development's Nuclear Energy Agency entitled ``An Economic
Study of the Molybdenum-99 Supply Chain'', underscores this
issue by citing that long-term subsidies have damaged
industry's attempts to enter the global Mo-99 market. To
provide a level playing field for U.S. companies, meet
nonproliferation goals, and build a non-HEU based industry for
Mo99, there must be a concerted global commitment that all new
or expanded long-term Mo-99 production be undertaken without
HEU. Very importantly, we must achieve full cost recovery
across the entire global commercial industry. Any foreign
government subsidy of HEU-based production puts the objectives
of this legislation at risk.
We have significant concerns about the scope, costs, and
other implications of Section 2(c), the ``Uranium Lease and
Take Back'' provision. In addition, the proposed program could
risk lengthening the timeframe to Mo-99 production if the
schedule of implementing the proposed ``Uranium Lease and Take
Back'' subprogram were to have any linkage to the expected
production schedule of the commercial projects to produce Mo-
99.
NNSA will use its existing, well-established program
management and procurement oversight tools to ensure that the
innovative non-HEU based technologies it supports are developed
on schedule and that cost-shared funds are properly applied so
that Mo-99 is delivered to the U.S. market on time and within
anticipated costs. NNSA will also coordinate closely with the
Nuclear Regulatory Commission and the Food and Drug
Administration on regulatory issues associated with the
commercial use of new technology.
To summarize, the Department of Energy and NNSA believe
that, overall, this legislation will be helpful in providing
public visibility to critical nonproliferation goals and to
equally critical medical needs. With clear commitment and
sustained support, we can secure our citizens' health needs as
well as their national security. I thank Senator Bingaman,
Ranking Member Murkowski, and Members of the Committee for your
continued leadership in supporting this legislation and we look
forward to working with you to address any issues raised here
today. I appreciate the opportunity to testify and am ready to
answer your questions.
Changes in Existing Law
In compliance with paragraph 12 of rule XXVI of the
Standing Rules of the Senate, changes in existing law made by
the bill S. 99, as ordered reported, are shown as follows
(existing law proposed to be omitted is enclosed in black
brackets, new matter is printed in italic, existing law in
which no change is proposed is shown in roman):
ATOMIC ENERGY ACT OF 1954
AN ACT To amend the Atomic Energy Act of 1946, as amended, and for
other purposes.
Be it enacted by the Senate and House of Representatives of
the United States of America in Congress assembled, That the
Atomic Energy Act of 1946, as amended, is amended to read as
follows:
ATOMIC ENERGY ACT OF 1954
TITLE I--ATOMIC ENERGY
* * * * * * *
CHAPTER 10. ATOMIC ENERGY LICENSES
* * * * * * *
Sec. 110. Exclusions.
Sec. 112. Domestic medical isotope production.
* * * * * * *
TITLE I--ATOMIC ENERGY
* * * * * * *
CHAPTER 10. ATOMIC ENERGY LICENSES
* * * * * * *
Sec. 111. a. The Nuclear Regulatory Commission is
authorized to license the distribution of special nuclear
material, source material, and byproduct material by the
Department of Energy pursuant to section 54, 64, and 82 of this
Act, respectively, in accordance with the same procedures
established by law for the export licensing of such material by
any person: Provided, That nothing in this section shall
require the licensing of the distribution of byproduct material
by the Department of Energy under section 82 of this Act.
b. The Department of Energy shall not distribute any
special nuclear material or source material under section 54 or
64 of this Act other than under an export license issued by the
Nuclear Regulatory Commission until (1) the Department has
obtained the concurrence of the Department of State and has
consulted with the Nuclear Regulatory Commission and the
Department of Defense under mutually agreed procedures which
shall be established within not more than ninety days after the
date of enactment of this provision and (2) the Department
finds based on a reasonable judgment of the assurances provided
and the information available to the United States Government,
that the criteria in section 127 of this Act or their
equivalent and any applicable criteria in subsection 128 are
met, and that the proposed distribution would not be inimical
to the common defense and security.
SEC. 112. DOMESTIC MEDICAL ISOTOPE PRODUCTION.--
a. The Commission may issue a license, or grant an
amendment to an existing license, for the use in the United
States of highly enriched uranium as a target for medical
isotope production in a nuclear reactor, only if in addition to
any other requirement of this Act--
(1) the Commission determines that--
(A) there is no alternative medical isotope
production target, enriched in the isotope U-
235 to less than 20 percent, that can be used
in that reactor; and
(B) the proposed recipient of the medical
isotope production target has provided
assurances that, whenever an alternative
medical isotope production target can be used
in that reactor, it will use that alternative
in lieu of highly enriched uranium;
(2) the Secretary of Energy has certified that the
United States Government is actively supporting the
development of an alternative medical isotope
production target that can be used in that reactor.
b. As used in this section--
(1) the term ``alternative medical isotope production
target'' means a nuclear reactor target which is
enriched to less than 20 percent of the isotope U-235;
(2) a target ``can be used'' in a nuclear research or
test reactor if--
(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 an agreement
with the United States Government to
convert to an alternative nuclear
reactor fuel when alternative nuclear
reactor fuel can be used in the
reactor.
(3) Review of physical protection requirements.--
(A) In general.--The Commission shall review
the adequacy of physical protection
requirements that, as of the date of an
application under paragraph (2), are applicable
to the transportation and storage of highly
enriched uranium for medical isotope production
or control of residual material after
irradiation and extraction of medical isotopes.
(B) Imposition of additional requirements.--
If the Commission determines that additional
physical protection requirements are necessary
(including a limit on the quantity of highly
enriched uranium that may be contained in a
single shipment), the Commission shall impose
such requirements as license conditions or
through other appropriate means.
(4) First report to congress.--
(A) NAS study.--The Secretary shall enter
into an arrangement with the National Academy
of Sciences to conduct a study to determine--
(i) the feasibility of procuring
supplies of medical isotopes from
commercial sources that do not use
highly enriched uranium;
(ii) the current and projected demand
and availability of medical isotopes in
regular current domestic use;
(iii) the progress that is being made
by the Department of Energy and others
to eliminate all use of highly enriched
uranium in reactor fuel, reactor
targets, and medical isotope production
facilities; and
(iv) the potential cost differential
in medical isotope production in the
reactors and target processing
facilities if the products were derived
from production systems that do not
involve fuels and targets with highly
enriched uranium.
(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.]
c. Effective 7 years after the date of enactment of the
American Medical Isotopes Production Act of 2010, the
Commission may not issue a license for the export of highly
enriched uranium from the United States for the purposes of
medical isotope production.
d. The period referred to in subsection b. may be extended
for no more than 6 years if, no earlier than 6 years after the
date of enactment of the American Medical Isotopes Production
Act of 2010, the Secretary of Energy certifies to the Committee
on Energy and Commerce of the House of Representatives and the
Committee on Energy and Natural Resources of the Senate that--
(1) there is insufficient global supply of
molybdenum-99 produced without the use of highly
enriched uranium available to satisfy the domestic
United States market; and
(2) the export of United States-origin highly
enriched uranium for the purposes of medical isotope
production is the most effective temporary means to
increase the supply of molybdenum-99 to the domestic
United States market.
e. To ensure public review and comment, the development of
the certification described in subsection c. shall be carried
out through announcement in the Federal Register.
f. At any time after the restriction of export licenses
provided for in subsection b. becomes effective, if there is a
critical shortage in the supply of molybdenum-99 available to
satisfy the domestic United States medical isotope needs, the
restriction of export licenses may be suspended for a period of
no more than 12 months, if--
(1) the Secretary of Energy certifies to the Congress
that the export of United States-origin highly enriched
uranium for the purposes of medical isotope production
is the only effective temporary means to increase the
supply of molybdenum-99 necessary to meet United States
medical isotope needs during that period; and
(2) the Congress enacts a Joint Resolution approving
the temporary suspension of the restriction of export
licenses.
g. As used in this section--
(1) the term ``alternative nuclear reactor fuel or
target'' means a nuclear reactor fuel or target which
is enriched to less than 20 percent in the isotope U-
235;
(2) the term ``highly enriched uranium'' means
uranium enriched to 20 percent or more in the isotope
U-235;
(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.
* * * * * * *