II
Calendar No. 263
111th CONGRESS
2d Session
H. R. 3276
[Report No. 111–120]
IN THE SENATE OF THE UNITED STATES
November 6, 2009
Received; read twice and referred to the Committee on Energy and Natural Resources
January 28, 2010
Reported by Mr. Bingaman, with amendments
Omit the part struck through and insert the part printed in italic
AN ACT
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.
Short title
This Act may be cited as the American
Medical Isotopes Production Act of
.2009
Findings
Congress finds the following:
Molybdenum-99 is a critical medical isotope whose decay product technecium-99m is used in approximately two-thirds of all diagnostic medical isotope procedures in the United States, or 16 million medical procedures annually, including for the detection of cancer, heart disease, and thyroid disease, investigating the operation of the brain and kidney, imaging stress fractures, and tracking cancer stages.
Molybdenum-99 has a half-life of 66 hours, and decays at a rate of approximately one percent per hour after production. As such, molybdenum-99 cannot be stockpiled. Instead, molybdenum-99 production must be scheduled to meet the projected demand and any interruption of the supply chain from production, to processing, packaging, distribution, and use can disrupt patient care.
There are no facilities within the United States that are dedicated to the production of molybdenum-99 for medical uses. The United States must import molybdenum-99 from foreign production facilities, and is dependent upon the continued operation of these foreign facilities for millions of critical medical procedures annually.
Most reactors in
the world which produce molybdenum-99 utilize highly enriched uranium, which
can also be used in the construction of nuclear weapons. In January 2009, the
National Academy of Sciences encouraged molybdenum-99 producers to convert from
highly enriched uranium to low enriched uranium, and found that there are
no technical reasons that adequate quantities cannot be produced from
LEU targets in the future
and that a 7-10 year phase-out period
would likely allow enough time for all current HEU-based producers to
convert
.
The 51-year-old National Research Universal reactor in Canada, which is responsible for producing approximately sixty percent of United States demand for molybdenum-99 under normal conditions, was shut down unexpectedly May 14, 2009, after the discovery of a leak of radioactive water. It is unclear whether the National Research Universal reactor will be able to resume production of molybdenum-99.
The United States currently faces an acute shortage of molybdenum-99 and its decay product technetium-99m due to technical problems which have seriously interrupted operations of foreign nuclear reactors producing molybdenum-99.
As a result of the critical shortage of molybdenum-99, patient care in the United States is suffering. Medical procedures requiring technetium-99 are being rationed or delayed, and alternative treatments which are less effective, more costly, and may result in increased radiation doses to patients are being substituted in lieu of technetium-99.
The radioactive isotope molybdenum-99 and its decay product technetium-99m are critical to the health care of Americans, and the continued availability of these isotopes, in a reliable and affordable manner, is in the interest of the United States.
The United States should move expeditiously to ensure that an adequate and reliable supply of molybdenum-99 can be produced in the United States, without the use of highly enriched uranium.
Other important medical isotopes, including
iodine-131 and xenon-133, can be produced as byproducts of the molybdenum-99
fission production process. In January 2009, the National Academy of Sciences
concluded that these important medical isotopes will be sufficiently
available if Mo-99 is available
. The coproduction of medically useful
isotopes such as iodine-131 and xenon-133 is an important benefit of
establishing molybdenum-99 production in the United States without the use of
highly enriched uranium, and these coproduced isotopes should also be available
for necessary medical uses.
The United States
should accelerate its efforts to convert nuclear reactors worldwide away from
the use of highly enriched uranium, which can be used in nuclear weapons, to
low enriched uranium. Converting nuclear reactors away from the use of highly
enriched uranium is a critically important element of United States efforts to
prevent nuclear terrorism, and supports the goal announced in Prague by
President Barack Obama on April 5, 2009, to create a new international
effort to secure all vulnerable nuclear material around the world within four
years
.
The United States is engaged in an effort to convert civilian nuclear test and research reactors from highly enriched uranium fuel to low enriched uranium fuel through the Global Threat Reduction Initiative. As of September 2009, this program has successfully converted 17 reactors in the United States to low enriched uranium fuel, some of which are capable of producing molybdenum-99 for medical uses.
Improving the reliability of domestic medical isotope supply
Medical isotope development projects
In general
The Secretary of
Energy shall establish a
program 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. shall establish a technology-neutral
program—
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;
to be carried out in cooperation with non-Federal entities; and
the costs of which shall be shared in accordance with section 988 of the Energy Policy Act of 2005 (42 U.S.C. 16352).
Criteria
Projects shall be judged against the following primary criteria:
The length of time necessary for the proposed project to begin production of molybdenum-99 for medical uses within the United States.
The capability of the proposed project to produce a significant percentage of United States demand for molybdenum-99 for medical uses.
The cost of the proposed project.
Exemption
An existing reactor fueled with highly enriched uranium shall not be disqualified from the program if the Secretary of Energy determines that—
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;
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
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.
Public participation and review
The Secretary of Energy shall—
develop a program plan and annually update the program plan through public workshops; and
use the Nuclear Science Advisory Committee to conduct annual reviews of the progress made in achieving the program goals.
Authorization of appropriations
There are authorized to be appropriated to the Secretary of Energy for carrying out the program under paragraph (1) $163,000,000 for the period encompassing fiscal years 2010 through 2014.
Development assistance
The Secretary of Energy shall establish a program to provide assistance for—
the development of fuels, targets, and processes for domestic molybdenum-99 production that do not use highly enriched uranium; and
commercial operations using the fuels, targets, and processes described in paragraph (1).
Uranium lease and take back
The Secretary of Energy shall establish a program to make low enriched uranium available, through lease contracts, for irradiation for the production of molybdenum-99 for medical uses. The lease contracts shall provide for the Secretary to retain responsibility for the final disposition of radioactive waste created by the irradiation, processing, or purification of leased uranium. The lease contracts shall also 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 the final disposition of such radioactive waste, provided that the discount rate used to determine the net present value of such costs shall be no greater than the average interest rate on marketable Treasury securities. The Secretary shall not barter or otherwise sell or transfer uranium in any form in exchange for services related to final disposition of the radioactive waste from such leased uranium.
Exports
Section 134 of the Atomic Energy Act of 1954
(42 U.S.C. 2160d2160d) is amended by striking
subsections b. and c. and inserting in lieu thereof the following:(b)
Effective 7 years after the date of
enactment of the American Medical Isotopes Production Act of
20092010, 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.
The period referred
to in subsection b. may be extended for no more than
four 6 years if, no earlier than 6
years after the date of enactment of the American Medical Isotopes Production
Act of 20092010, 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—
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
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.
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.
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—
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
the Congress
passesenacts a Joint Resolution
approving the temporary suspension of the restriction of export
licenses.
As used in this section—
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;
the term
highly enriched uranium
means uranium enriched to 20 percent or
more in the isotope U-235;
a fuel or target
can be used
in a nuclear research or test reactor if—
the fuel or target has been qualified by the Reduced Enrichment Research and Test Reactor Program of the Department of Energy; and
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
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.
.
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, including—
their location;
whether they are irradiated;
whether they have been used for the purpose stated in their export license;
whether they have been used for an alternative purpose and, if so, whether such alternative purpose has been explicitly approved by the Commission;
the year of export, and reimportation, if applicable;
their current physical and chemical forms; and
whether they are being stored in a manner which adequately protects against theft and unauthorized access.
Domestic medical isotope production
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 new section:
Domestic medical isotope production
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—
the Commission determines that—
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
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
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.
As used in this section—
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;
a target can be used
in a
nuclear research or test reactor if—
the target has been qualified by the Reduced Enrichment Research and Test Reactor Program of the Department of Energy; and
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;
the term
highly enriched uranium
means uranium enriched to 20 percent or
more in the isotope U-235; and
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.
.
Table of contents
The table of contents for the Atomic Energy Act of 1954
is amended by inserting the following new item
after the item relating
to section 111:
at the end of the items relating to chapter 10 of title
I:
Sec. 112. Domestic medical isotope production.
.
Annual Department of Energy reports
The Secretary of Energy shall report to Congress no later than one year after the date of enactment of this Act, and annually thereafter for 5 years, on Department of Energy actions to support the production in the United States, without the use of highly enriched uranium, of molybdenum-99 for medical uses. These reports shall include the following:
For medical isotope development projects—
the names of any
recipients of Department of Energy support under
section
3 section
2 of this Act;
the amount of Department of Energy funding committed to each project;
the milestones expected to be reached for each project during the year for which support is provided;
how each project is expected to support the increased production of molybdenum-99 for medical uses;
the findings of
the evaluation of projects under section
3(a)(2) 2(a)(2) of this Act; and
the ultimate use
of any Department of Energy funds used to support projects under
section
3 section
2 of this Act.
A description of actions taken in the previous year by the Secretary of Energy to ensure the safe disposition of radioactive waste from used molybdenum-99 targets.
National Academy of Sciences report
The Secretary of Energy 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 the Congress not later than 5 years after the date of enactment of this Act. This report shall include the following:
For molybdenum-99 production—
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;
a review of international production of molybdenum-99 over the previous 5 years, including—
whether any new production was brought online;
whether any facilities halted production unexpectedly; and
whether any facilities used for production were decommissioned or otherwise permanently removed from service; and
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
coproducedthat have been produced with
molybdenum-99, such as iodine-131 and xenon-133, are being used for medical
purposes.
An assessment of the progress made by the Department of Energy and others to eliminate all worldwide use of highly enriched uranium in reactor fuel, reactor targets, and medical isotope production facilities.
Definitions
In this Act the following definitions apply:
Highly enriched uranium
The term highly enriched uranium means uranium enriched to 20 percent or greater in the isotope U-235.
Low enriched uranium
The term low enriched uranium means uranium enriched to less than 20 percent in the isotope U-235.
January 28, 2010
Reported with amendments