Appendix A
Section 630 of the Energy Policy Act of 2005

SEC. 630. MEDICAL ISOTOPE PRODUCTION.


Section 134 of the Atomic Energy Act of 1954 (42 U.S.C. 2160d) is amended—

  1. in subsection a., by striking “a. The Commission” and inserting “a. IN GENERAL.—Except as provided in subsection b., the Commission”;

  2. by redesignating subsection b. as subsection c.; and

  3. by inserting after subsection a. the following:

    “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



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Appendix A Section 630 of the Energy Policy Act of 2005 SEC. 630. MEDICAL ISOTOPE PRODUCTION. Section 134 of the Atomic Energy Act of 1954 (42 U.S.C. 2160d) is amended— (1) in subsection a., by striking ‘‘a. The Commission’’ and inserting ‘‘a. IN GENERAL.—Except as provided in subsection b., the Commission’’; (2) by redesignating subsection b. as subsection c.; and (3) by inserting after subsection a. the following: ‘‘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 

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0 APPENDIX A 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

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 APPENDIX A 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 theNational 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

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 APPENDIX A 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.’’.