[Congressional Record Volume 157, Number 10 (Tuesday, January 25, 2011)]
[Senate]
[Pages S187-S191]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

      By Mr. BINGAMAN (for himself and Ms. Murkowski):
  S. 99. A bill 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; to the Committee on Energy and Natural Resources.
  Mr. BINGAMAN. Mr. President, today I am introducing the American 
Medical Isotopes Production Act of 2011. The purpose of the bill is to 
provide certainty in developing a domestic supply of molybdenum-99, 
which is used to produce technetium-99m, one of the most widely used 
medical isotopes in the United States. Right now we import all of our 
molybdenum-99 from outside the United States, primarily Canada and the 
Netherlands, from reactors that are old and that will most likely be 
shut down within the next 10 years. In addition, this bill moves us 
away from using highly enriched bomb-grade uranium targets to those 
that are low-enriched; that is, that are less than 20 percent in the 
fissile isotope uranium-235. I think this is a very important 
nonproliferation goal because the world is currently in discussion with 
Iran on replacing fuel and targets from their medical isotopes reactor; 
we should lead by example in dealing in this area with countries like 
Iran that can now enrich nuclear fuel.
  The Committee on Energy and Natural Resources held a very detailed 
hearing on this topic last Congress. The bill we reported unanimously 
had a wide body of support among the medical isotopes and non-
proliferation communities. I am attaching several letters from the last 
Congress as evidence of the wide support for this bill.
  The new bill that I am introducing today is identical to the bill 
reported by the Committee in the last Congress, H.R. 3276, as amended. 
There are only two differences between this bill and the one from the 
last Congress. The authorization level has been lowered by $20 million 
to account for the fact that we are in fiscal year 2011 and not fiscal 
year 2010, and technical PAYGO language has been added.
  Mr. President, I ask unanimous consent that the text of the bill and 
letters of support be printed in the Record.
  There being no objection, the material was ordered to be printed in 
the Record, as follows:

                                 S. 99

       Be it enacted by the Senate and House of Representatives of 
     the United States of America in Congress assembled,

     SECTION 1. SHORT TITLE.

       This Act may be cited as the ``American Medical Isotopes 
     Production Act of 2011''.

     SEC. 2. IMPROVING THE RELIABILITY OF DOMESTIC MEDICAL ISOTOPE 
                   SUPPLY.

       (a) Medical Isotope Development Projects.--
       (1) In general.--The Secretary of Energy 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 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 review.--The Secretary of 
     Energy shall--
       (A) develop a program plan and annually update the program 
     plan through public workshops; and
       (B) use the Nuclear Science Advisory Committee to conduct 
     annual reviews of the progress made in achieving the program 
     goals.
       (5) Authorization of appropriations.--There are authorized 
     to be appropriated to the Secretary of Energy 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 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 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.

     SEC. 3. EXPORTS.

       Section 134 of the Atomic Energy Act of 1954 (42 U.S.C. 
     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 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.
       ``c. The period referred to in subsection b. may be 
     extended for no more than 6 years if, no earlier than 6 years 
     after the date of enactment of the American Medical Isotopes 
     Production Act of 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.
       ``d. To ensure public review and comment, the development 
     of the certification described in subsection c. shall be 
     carried out through announcement in the Federal Register.
       ``e. At any time after the restriction of export licenses 
     provided for in subsection b. becomes effective, if there is 
     a critical shortage in the supply of molybdenum-99 available 
     to satisfy the domestic United States medical isotope needs, 
     the restriction of export licenses may be suspended for a 
     period of no more than 12 months, if--
       ``(1) the Secretary of Energy certifies to the Congress 
     that the export of United States-origin highly enriched 
     uranium for the purposes of medical isotope production is the 
     only effective temporary means to increase the supply of 
     molybdenum-99 necessary to meet United States medical isotope 
     needs during that period; and
       ``(2) the Congress enacts a Joint Resolution approving the 
     temporary suspension of the restriction of export licenses.
       ``f. As used in this section--
       ``(1) the term `alternative nuclear reactor fuel or target' 
     means a nuclear reactor fuel or target which is enriched to 
     less than 20 percent in the isotope U-235;
       ``(2) the term `highly enriched uranium' means uranium 
     enriched to 20 percent or more in the isotope U-235;
       ``(3) a fuel or target `can be used' in a nuclear research 
     or test reactor if--
       ``(A) the fuel or target has been qualified by the Reduced 
     Enrichment Research and Test Reactor Program of the 
     Department of Energy; and
       ``(B) use of the fuel or target will permit the large 
     majority of ongoing and planned experiments and isotope 
     production to be conducted in the reactor without a large 
     percentage increase in the total cost of operating the 
     reactor; and

[[Page S189]]

       ``(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.''.

     SEC. 4. 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--
       (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. 5. 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 new section:
       ``Sec. 112. Domestic Medical Isotope Production.-- a. The 
     Commission may issue a license, or grant an amendment to an 
     existing license, for the use in the United States of highly 
     enriched uranium as a target for medical isotope production 
     in a nuclear reactor, only if, in addition to any other 
     requirement of this Act--
       ``(1) the Commission determines that--
       ``(A) there is no alternative medical isotope production 
     target, enriched in the isotope U-235 to less than 20 
     percent, that can be used in that reactor; and
       ``(B) the proposed recipient of the medical isotope 
     production target has provided assurances that, whenever an 
     alternative medical isotope production target can be used in 
     that reactor, it will use that alternative in lieu of highly 
     enriched uranium; and
       ``(2) the Secretary of Energy has certified that the United 
     States Government is actively supporting the development of 
     an alternative medical isotope production target that can be 
     used in that reactor.
       ``b. As used in this section--
       ``(1) the term `alternative medical isotope production 
     target' means a nuclear reactor target which is enriched to 
     less than 20 percent of the isotope U-235;
       ``(2) a target `can be used' in a nuclear research or test 
     reactor if--
       ``(A) the target has been qualified by the Reduced 
     Enrichment Research and Test Reactor Program of the 
     Department of Energy; and
       ``(B) use of the target will permit the large majority of 
     ongoing and planned experiments and isotope production to be 
     conducted in the reactor without a large percentage increase 
     in the total cost of operating the reactor;
       ``(3) the term `highly enriched uranium' means uranium 
     enriched to 20 percent or more in the isotope U-235; and
       ``(4) the term `medical isotope' includes molybdenum-99, 
     iodine-131, xenon-133, and other radioactive materials used 
     to produce a radiopharmaceutical for diagnostic, therapeutic 
     procedures or for research and development.''.
       (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. 6. 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:
       (1) For medical isotope development projects--
       (A) the names of any recipients of Department of Energy 
     support under 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 2(a)(2) of this Act; and
       (F) the ultimate use of any Department of Energy funds used 
     to support projects under 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.

     SEC. 7. 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:
       (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 of 
     Energy and others to eliminate all worldwide use of highly 
     enriched uranium in reactor fuel, reactor targets, and 
     medical isotope production facilities.

     SEC. 8. DEFINITIONS.

       In this Act the following definitions apply:
       (1) Highly enriched uranium.--The term ``highly enriched 
     uranium'' means uranium enriched to 20 percent or greater in 
     the isotope U-235.
       (2) Low enriched uranium.--The term ``low enriched 
     uranium'' means uranium enriched to less than 20 percent in 
     the isotope U-235.

     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.
                                  ____



                                                          SNM,

                                                    July 21, 2010.
     Hon. Harry Reid,
     Senate Majority Leader, U.S. Senate, U.S. Capitol, S-221, 
         Washington, DC.
     Hon. Jeff Bingaman,
     Chairman, Senate Committee on Energy and Natural Resources, 
         U.S. Senate, Washington, DC.
     Hon. Mitch McConnell,
     Senate Minority Leader, U.S. Senate, U.S. Capitol, S-231, 
         Washington, DC.
     Hon. Lisa Murkowski,
     Ranking Member, Senate Committee on Energy and Natural 
         Resources, U.S. Senate, Washington, DC.
       Dear Majority Leader Reid, Minority Leader McConnell, 
     Chairman Bingaman, and Ranking Member Murkowski: The Society 
     of Nuclear Medicine (SNM), a leading, multidisciplinary 
     international scientific and professional organization with 
     more than 17,000 physician, technologist, and scientist 
     members dedicated to promoting the science, technology, and 
     practical applications of molecular imaging and nuclear 
     medicine, respectfully requests that the Senate to take up 
     and pass the American Medical Isotopes Production Act of 2009 
     (H.R. 3276) as a stand-alone bill or as an amendment to an 
     appropriate legislative vehicle. Recent disruptions in the 
     international supply of Molybdenum-99 (Mo-99) have 
     highlighted the urgent need to ensure a domestic supply for 
     the U.S. H.R. 3276 would help to ensure a domestic supply of 
     Mo-99 over the long term and curtail the use of highly-
     enriched uranium (HEU) in radionuclide production as a non-
     proliferation strategy to deter terrorism.
       As you know, the House of Representatives approved this 
     bill by an overwhelming vote of 400--17 on November 5, 2009 
     and the Senate Energy and Natural Resources Committee 
     reported this bill favorably with amendments on January 28, 
     2010. SNM believes that rapid passage of this legislation is 
     essential to ensure Americans' access to vital medical 
     radionuclides and give patients timely access to appropriate 
     heart and cancer testing.
       Molybdenum-99 (Mo-99) decays into Technetium-99m (Tc-99m), 
     which is used in approximately 16 million nuclear medicine 
     procedures each year in the U.S. Tc-99m is used in the 
     detection and staging of cancer, detection of heart disease, 
     detection of thyroid disease, study of brain and kidney 
     function, and imaging of stress fractures. In addition to 
     pinpointing the underlying cause of disease, physicians can 
     actually see how a disease is affecting other functions in 
     the body. Imaging with Tc-99m is an important part of patient 
     care. SNM, along with thousands of nuclear medicine 
     physicians in the U.S., has, over the course of the last two 
     years, been disturbed about supply interruptions of Mo-99 
     from foreign vendors and the lack of a reliable supplier of 
     Mo-99 in the U.S. Due to these recent shutdowns in Canada, 
     numerous nuclear medicine professionals across the country 
     have delayed or had to cancel imaging procedures. Because Mo-
     99 is produced through the fission of uranium and has a half-
     life of 66 hours, it cannot be produced and then stored for 
     long periods of time. Unlike traditional pharmaceuticals, 
     which are dispensed by pharmacists or sold over-the-

[[Page S190]]

     counter, nuclear reactors produce radioactive isotopes that 
     are processed and provided to hospitals and other nuclear 
     medicine facilities based on demand. Any disruption to the 
     supply chain can wreak havoc on patient access to important 
     medical imaging procedures.
       In order to ensure that patient needs are not compromised, 
     a continuous reliable supply of medical radioisotopes is 
     essential.
       Currently there are no facilities in the U.S. that are 
     dedicated to manufacturing Mo-99 for Mo-99/Tc-99m generators. 
     The United States must develop domestic capabilities to 
     produce Mo-99 and not rely solely on foreign suppliers. The 
     legislation encourages domestic production of Mo-99 for 
     medical isotopes without HEU in two different ways. First, it 
     would facilitate the operation of new facilities by granting 
     the government the ability ``to retain responsibility for the 
     final disposition of radioactive waste'' under uranium-lease 
     agreements. The Department of Energy (DoE) does not currently 
     have this ability and cannot assume the responsibility for 
     domestic producers' radioactive waste. The bill also 
     authorizes government cost-sharing which would subsidize 
     construction of production facilities. Without the multi-year 
     authorization that is included in H.R. 3276, investments in 
     domestic productive facilities will be prohibitively 
     uncertain.
       There is significant support for passing this piece of 
     legislation, which has been endorsed by a variety of 
     organizations. Further, at a House Energy and Environment 
     Subcommittee on September 9, 2009, Parrish Staples, the U.S. 
     official who oversees medical isotope production at DoE's 
     National Nuclear Security Administration (NNSA) testified as 
     follows:

       ``NNSA is working on several Cooperative Agreements to 
     potential commercial Mo-99 producers, whose projects are in 
     the most advanced stages of development, accelerating their 
     efforts to begin producing Mo-99 in quantities adequate to 
     the U.S. medical community's demand by the end of 2013. . . . 
     The American Medical Isotopes Production Act of 2009 is 
     crucial to ensuring the success of these efforts to 
     accelerate development of a domestic supply of Mo-99 with the 
     use of HEU.

       At the subsequent Senate hearing, Dr. Staples stated:

       ``Currently, we are working or we would intend to work that 
     we would develop four independent technologies, each capable 
     of supplying up to 50 percent of the U.S. demand. Obviously, 
     in theory, that means that if each of these are successful, 
     we could supply the global requirement for this isotope''--
     roughly twice the U.S. domestic demand. In other words, under 
     the legislation, the projected U.S. domestic production 
     capacity could satisfy US demand prior to the cutoff of HEU 
     exports, even if only half of the four main projects 
     succeeded.''

       Passage of this legislation is necessary to help address 
     the future needs of patients by promoting the production of 
     Mo-99 in the United States. We thank you for your efforts and 
     look forward to continuing to work with you on this important 
     issue. Should you have any further questions, please contact 
     Cindy Tomlinson, Associate Director, Health Policy and 
     Regulatory Affairs at either [email protected] or 
     703.326.1187.
           Sincerely,
                                                Dominique Delbeke,
     President.
                                  ____



                                       Health Physics Society,

                                                November 30, 2009.
     Hon. Jeff Bingaman, Chair
     Hon. Lisa Murkowski, Ranking Member
     Energy and Natural Resources Committee, U.S. Senate, 
         Washington, DC.
       Dear Senators Bingaman and Murkowski: On behalf of the 
     Health Physics Society (HPS), I urge the Senate Energy and 
     Natural Resources Committee to give full support to and take 
     timely action on H.R. 3276, the ``American Medical Isotope 
     Production Act of 2009.''
       The Health Physics Society, a nonprofit scientific 
     organization of approximately 5000 radiation safety 
     professionals, has joined with eight other professional 
     organizations in a coalition to address two concerns of 
     national importance: (1) an inherent need for reliable 
     domestic suppliers of Molybdenum-99 (Mo-99); and, (2) efforts 
     to curtail the use of high-enriched uranium (HEU) in 
     radionuclide production as a non-proliferation strategy and 
     to deter terrorism. A discussion of these concerns with 
     recommendations for action by the United States is contained 
     in a white paper by the coalition of professional 
     organizations titled ``Reliable Domestic & Global Supplier of 
     Molybdenum-99 (Mo-99) and Switch from Highly Enriched Uranium 
     (HEU) to Low-Enriched Uranium (LEU) to Produce Mo-99.'' The 
     white paper is accessible at http://hps.org/documents/
isotopes_white-paper_multiorganization.pdf.
       A national effort to address these concerns requires (1) a 
     commitment by the administration to have a coordinated inter-
     agency program with the specific responsibility to achieve 
     reliable domestic independence in the production of Mo-99, 
     (2) continued appropriations by Congress to provide the 
     financial investment needed by the administration's program, 
     and (3) support of the Congress through authorizing 
     legislation that will serve as the basis for the continuation 
     of the administration's program until its goals are achieved.
       The Obama administration has made a commitment to achieve 
     domestic independence in the production of Mo-99. The HPS 
     believes the initiative being led by the National Nuclear 
     Security Administration through the Global Threat Reduction 
     Initiative with oversight and interagency coordination by the 
     Office of Science and Technology Policy has the capability to 
     achieve the establishment of a reliable domestic production 
     of Mo-99 within the next ten years. The Congress has 
     appropriated sufficient support for fiscal year 2010. The 
     remaining task is to obtain congressional support through 
     authorizing legislation that will serve as the support and 
     basis for the administration's program into the future.
       The HPS believes H.R. 3276 provides the needed 
     congressional support for the administration's program.
       We understand there may be some concern about the 
     provisions in H.R. 3276 for imposing a ban on export of HEU 
     at a fixed time in the future. HPS's interest in the issue of 
     domestic production of radioisotopes is related to the 
     radiation safety implications of the issue, including the 
     implications of exporting HEU for this purpose. In 2005, the 
     HPS did not support the inclusion of an HEU export ban 
     provision in the Energy Policy Act of 2005. The HPS felt that 
     the controls under which HEU was exported were rigorous 
     enough to make the export acceptably safe when compared to 
     the prospect of not having a supply of Mo-99. This position 
     was influenced by the lack of any administration program or 
     congressional support for a program dedicated to the domestic 
     production of radioisotopes. The HPS still considers the 
     controls for export of HEU for production of radioisotopes to 
     be rigorous enough to make the risk of diversion for 
     terrorism, or other malicious use of the HEU to be 
     speculative. However, we feel that with appropriate 
     congressional support, the initiative to establish reliable 
     domestic production of Mo-99 will be successful within the 
     next ten years, making the need to export HEU unnecessary. 
     Therefore, we feel the export ban provisions will prove to be 
     extraneous and, therefore, do not form a basis for not 
     supporting H.R. 3276.
       I hope this letter is helpful in your considered 
     deliberation of action on H.R. 3276. Please do not hesitate 
     to contact me if you have any questions about this letter or 
     HPS support for H.R. 3276.
           Sincerely,
     Howard W. Dickson.
                                  ____

                                                February 23, 2010.
     Hon. Jeff Bingaman,
     Chairman,
     Washington, DC.
     Hon. Lisa Murkowski,
     Ranking Member,
     Washington, DC.
       Dear Chairman Bingaman and Ranking Member Murkowski: As a 
     coalition made up of the Society of Nuclear Medicine (SNM), 
     American Association of Physicists in Medicine (AAPM), 
     American College of Radiology (ACR), American Nuclear Society 
     (ANS), American Society of Nuclear Cardiology (ASNC), 
     American Society for Radiation Oncology (ASTRO), Health 
     Physics Society (HPS), Nuclear Energy Institute (NEI), 
     Academy of Molecular Imaging (AMI), the non-proliferation 
     community, Union of Concerned Scientists (UCS), National 
     Association of Nuclear Pharmacies (NANP) and the Council on 
     Radionuclides and Radiopharmaceuticals (CORAR), we ask that 
     you support the timely passage of H.R. 3276, the American 
     Medical Isotope Production Act of 2009. The Senate Energy and 
     Natural Resources Committee held a hearing on the bill 
     December 3, 2009, and unanimously approved the bill with an 
     amendment on December 16, 2009. We understand it is currently 
     on the Senate calendar but we are asking for your assistance 
     in bringing this legislation forward for action by the 
     Senate.
       H.R. 3276 is urgently needed legislation that would provide 
     the U.S. Department of Energy the authority to aid in the 
     domestic development of essential medical isotope production. 
     H.R. 3276 is intended to help ensure that U.S. patients have 
     a stable and reliable supply of diagnostic and therapeutic 
     medical isotopes within the next ten years, while converting 
     the production process to avoid highly enriched uranium 
     (HEU), in keeping with U.S. non-proliferation policy.
       The legislation would facilitate the adequate production of 
     isotopes without HEU prior to the restriction of HEU exports. 
     In the unexpected event that conversion were delayed, the 
     legislation provides for a waiver to permit continued HEU 
     exports to avoid a ``critical shortage'' of isotopes. The 
     legislation thus ensures both the supply of isotopes and the 
     timely phase out of HEU exports.
       Moreover, as you may know, on November 5, 2009, the House 
     passed H.R. 3276 by a vote of 400-17. Sponsored by 
     Representative Edward Markey (D-Mass.) and Representative 
     Fred Upton (R-Mich.), the Act is balanced, bipartisan 
     legislation that addresses the current shortfall in the 
     availability of critical medical isotopes that has had a high 
     negative impact on patients in the U.S.
       Molybdenum-99 (Mo-99) is a critical medical radioisotope 
     whose decay product Technetium-99m (Tc-99m) is used in more 
     than 16 million nuclear medicine procedures annually across 
     the nation. Physicians who use Tc-99m for the diagnosis of 
     common cancers, heart and other diseases, fully rely upon a 
     steady and predictable supply. The very

[[Page S191]]

     short six-hour half-life of Tc-99m, while beneficial to 
     patients and health care professionals, precludes any efforts 
     to maintain an inventory. In addition, the domestic supply of 
     Mo-99 (to produce Tc-99m-generators) is entirely dependent 
     upon aging foreign reactors that have faced extended 
     shutdowns for repair and maintenance.
       As a consequence, the U.S. supply has been repeatedly and 
     significantly disrupted. Many patients who need imaging with 
     Tc-99m-based radiopharmaceuticals are now facing lengthy 
     delays in the availability of nuclear medicine imaging, or 
     being forced to resort to alternative diagnostic and 
     therapeutic procedures that may involve the potential of more 
     invasive procedures (with possible higher clinical risks to 
     patients), greater radiation dosage, lower accuracy, and 
     higher costs.
       Additionally, the reliance on foreign reactors for the 
     supply of Mo-99 requires the U.S. to ship highly enriched 
     uranium, material of interest for use in nuclear terrorism, 
     out of the country. Domestic production of Mo-99 will 
     eliminate the risk that this nuclear material can be diverted 
     for terrorists' use, thus increasing the effectiveness of the 
     U.S. program for non-proliferation of nuclear materials.
       The coalition believes the initiative being led by the 
     National Nuclear Security Administration through the Global 
     Threat Reduction Initiative with oversight and interagency 
     coordination by the Office of Science and Technology Policy 
     has the capability to achieve the establishment of a reliable 
     domestic production of Mo-99 within the next ten years. The 
     Congress has appropriated sufficient support for fiscal year 
     2010. The remaining task is to obtain congressional support 
     through authorizing legislation that will serve as the 
     support and basis for the administration's program into the 
     future.
       In order to avoid compromising patient care and increasing 
     medical costs, a continuous and reliable supply of medical 
     radioisotopes is clearly essential. It is also critical that 
     domestic production capability for Mo-99 be developed. H.R. 
     3276 provides the needed support to accelerate the process of 
     conversion so that the industry can move even more 
     aggressively in this direction and be able to meet the time 
     frame highlighted in this bill.
       Senator, we hope you will join the patients, physicians, 
     nuclear non-proliferation community, radioisotope 
     manufacturers, and our coalition of professional 
     organizations to quickly enact H.R. 3276. We would welcome 
     the opportunity to answer any question you or your staff may 
     have about the bill or the medical isotope industry. Thank 
     you.
           Sincerely,
         Michael M. Graham, MD, President, SNM; Michael G. Herman, 
           Ph.D., FAAPM, FACMP, President, The American 
           Association of Physicists in Medicine, AAPM; James H. 
           Thrall, MD, FACR, Chair, Board of Chancellors, American 
           College of Radiology, ACR; Thomas Sanders, PhD, 
           President, American Nuclear Society, ANS; Mylan C. 
           Cohen, MD, MPH, President, American Society of Nuclear 
           Cardiology, ASNC; Laura Thevenot, CAE, Chief Executive 
           Officer, American Society for Radiation Oncology, 
           ASTRO; Howard W. Dickson, CHP, President, Health 
           Physics Society, HPS; Marvin S. Fertel, President and 
           Chief Executive Officer, Nuclear Energy Institute, NEI; 
           Timothy McCarthy, President, Academy of Molecular 
           Imaging, AMI; Alan J. Kuperman, Ph.D., Director, 
           Nuclear Proliferation Prevention Program, University of 
           Texas at Austin; Edwin S. Lyman, Senior Staff 
           Scientist, Union of Concerned Scientists; Jeff 
           Norenberg, PharmD, Executive Director, National 
           Association of Nuclear Pharmacies, NANP; Franklin B. 
           Yeager, Chairman, Council on Radionuclides & 
           Radiopharmaceuticals, CORAR.
                                 ______