1.This Act may be cited as the American
Medical Isotopes Production Act of
20092010
.
2.Congress finds the following:
(1)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.
(2)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.
(3)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.
(4)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
.
(5)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.
(6)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.
(7)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.
(8)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.
(9)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.
(10)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.
(11)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
.
(12)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.
3.2.Improving the
reliability of domestic medical isotope supply
(a)Medical isotope
development projects
(1)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—
(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)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)An
existing reactor fueled with highly enriched uranium shall not be disqualified
from the program if the Secretary of Energy 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 reviewThe 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.
(4)(5)Authorization
of appropriationsThere 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.
(b)The Secretary of Energy 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 backThe 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.
4.3.Section 134 of the Atomic Energy Act of 1954
(42 U.S.C. 2160d(b)2160d) 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.
c.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—
(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.
d.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
passesenacts a Joint Resolution
approving the temporary suspension of the restriction of export
licenses.
e.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.
.
5.4.Report on
disposition of exportsNot
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—
(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.
6.5.Domestic
medical isotope production
(a)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:
112.Domestic
medical isotope productiona.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.
.
(b)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.
.
7.6.Annual
Department of Energy reportsThe 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:
(1)For medical
isotope development projects—
(A)the names of any
recipients of Department of Energy support under
section
3 section
2 of this Act;
(B)the amount of
Department of Energy 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) 2(a)(2) of this Act; and
(F)the ultimate use
of any Department of Energy funds used to support projects under
section
3 section
2 of this Act.
(2)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.
8.7.National
Academy of Sciences reportThe
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:
(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
coproducedthat 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 of Energy and others to eliminate all
worldwide use of highly enriched uranium in reactor fuel, reactor targets, and
medical isotope production facilities.
9.8.In this Act the following definitions
apply:
(1)The term highly
enriched uranium means uranium enriched to 20 percent or greater in the
isotope U-235.
(2)The term low
enriched uranium means uranium enriched to less than 20 percent in the
isotope U-235.
January 28, 2010
Reported with amendments