FY 2013 National Defense Authorization Act: Medical Isotopes

President Barack Obama has signed into law H.R. 4310, the National Defense Authorization Act for FY 2013. This legislation provides policy and budget guidance for the Department of Defense and the National Nuclear Security Administration (NNSA). It does not provide the actual funding, which is contained in the yet to be enacted FY 2013 Department of Defense Appropriations Bill.

The final bill contains language on the development of a domestic supply of the medical isotope molybdenum-99. Congress has expressed concern about the availability of MO-99 through a series of hearings and bills. As shown below, the defense bill includes, with some modifications, the American Medical Isotopes Production Act , first introduced in 2009.

The conference report explains how major differences between the House and Senate versions of the FY 2013 authorization bill were resolved. The report language briefly summarizes the respective positions of the House and Senate authorizing committees regarding a particular section of their bill and explains the final position each chamber’s conferees took in resolving the matter. The “sec.” number refers to the actual bill text.

American Medical Isotopes Act of 2012 (secs. 3171–3178)

“The Senate amendment [which was adopted in this legislation with minor modification] contained nine provisions (sections 3151–3159) that comprised a program to develop a domestic supply of the medical isotope molybdenum–99 (MO–99) using low enriched uranium while phasing out the export of highly enriched uranium for production of medical isotopes. An abbreviated description is as follows.

“Section 3151 would provide a short title.

“Section 3152 would define terms used throughout the Act.

“Section 3153 would direct the Secretary of Energy to establish a technology-neutral, cost-shared program to evaluate and support projects for the domestic production of MO–99 for medical uses without the use of highly enriched uranium.

“Section 3154 would amend section 134 of the Atomic Energy Act (AEA) of 1954 (42 U.S.C. 2160d), by striking subsection (c), and by adding 5 new subsections designated (c) through (f). New subsection (c) would prohibit 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 subsection (d) would permit 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 MO–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 MO–99. New subsection (e) would require public notice and comment on the certification. New subsection (f) would provide 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 MO–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 subsection (g) would define terms used in section 134 of the Atomic Energy Act of 1954.

“Section 3155 would require 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 3156 would add a new section 112 to the AEA 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 AEA, 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 3157 would require the Secretary to report to Congress 1 year after the date of enactment of this Act, 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 3158 would require the National Academy of Sciences to study the state of MO–99 production and use not later than 5 years after the date of enactment of this Act.

“Section 3159 would repeal The Nuclear Safety Research, Development and Demonstration Act of 1980 (42 U.S.C. 9701 et seq.).

“The House bill contained no similar provision.

“The House recedes [withdraws from its position] with an amendment that would require the Department of Energy, as part of its program to develop a domestic supply of MO–99 (section 3173), to produce MO–99 in a cost effective manner and that the Nuclear Science Advisory Committee, in addition to conducting annual reviews of the program, make recommendations to improve the program’s effectiveness. In addition, the conferees expect that in pursuing the program in Section 3173, the Secretary of Energy shall ensure that the program is carried out in a technology neutral manner to reduce the use of highly enriched uranium and produce significant quantities of MO–99 for medical uses. Demonstration of technology necessary to domestically produce significant quantities of MO–99 for medical uses on a commercial scale seeks to address potential civilian use supply issues while also enhancing national security. Section 3173 requires the Secretary to cooperate with non-federal entities and share the costs incurred in the development, demonstration, and commercial application of the technology necessary to achieve the goals of the program, including the civilian medical applications.

“The amendment would also make technical changes in section 3174 and add a requirement that the Secretaries of Energy and Health and Human Services must jointly certify that before the provisions in subsections (c) and (d) take effect there is a sufficient supply of MO–99 produced without the use of highly enriched uranium available to meet the needs of the patients in the United States; and that it is not necessary to export United States-origin highly enriched uranium for the purposes of medical isotope production in order to meet United States patient needs. In addition, the joint certification would be required not later than 7 years after the date of enactment of this Act. If the period referred to in subsection (c) is extended under subsection (d), the 7 year deadline would be extended by a period equal to the period of such extension under subsection (d).

“The amendment would also strike the repeal of The Nuclear Safety Research, Development and Demonstration Act of 1980 (42 U.S.C. 9701 et seq.).”