[Federal Register Volume 71, Number 76 (Thursday, April 20, 2006)]
[Rules and Regulations]
[Pages 20336-20340]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 06-3664]


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NUCLEAR REGULATORY COMMISSION

10 CFR Part 110

RIN 3150-AH88


Implementation of the Nuclear Export and Import Provisions of the 
Energy Policy Act of 2005

AGENCY: Nuclear Regulatory Commission

ACTION:  Final rule.

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SUMMARY: The Nuclear Regulatory Commission (NRC) is amending its 
regulations that govern the export and import of nuclear equipment and 
material to implement provisions of the Energy Policy Act of 2005 
signed into law on August 8, 2005. This amendment will facilitate 
exports to specified countries of high-enriched uranium for medical 
isotope production in reactors that are either utilizing low-enriched 
uranium (LEU) fuel or have agreed to convert to the use of LEU fuel. In 
addition, this final rule revises the definition of byproduct material 
to include discrete sources of radium-226, accelerator-produced 
radioactive material, and discrete sources of naturally occurring 
radioactive material. Finally, the rule will require specific licenses 
for exports and imports of radium-226 that meet the threshold values of 
the International Atomic Energy Agency's Code of Conduct on the Safety 
and Security of Radioactive Sources.

DATES: This final rule will become effective August 7, 2006.

ADDRESSES: Copies of the final rule and related documents may be viewed 
electronically on the public computers located at the NRC's Public 
Document Room (PDR), located at One White Flint North, 11555 Rockville 
Pike, Public File Area O1F21, Rockville, Maryland. These documents are 
also available electronically at the NRC's Public Electronic Reading 
Room on the Internet at http://www. nrc.gov/reading- rm/

[[Page 20337]]

adams. html. From this site, the public can gain entry into the NRC's 
Agencywide Document Access and Management System (ADAMS), which 
provides text and image files of NRC's public documents. For further 
information contact the PDR reference staff at 1 (800) 387-4209, (301) 
415-4737 or by e-mail to [email protected]. the final rule and related 
documents are also available on the NRC's rulemaking Web site at http://ruleforum.linl.gov. Address questions about our rulemaking Web site 
to Carol Gallagher (301) 415-5905; e-mail [email protected].

FOR FURTHER INFORMATION CONTACT: Brooke G. Smith, International Policy 
Analyst, Office of International Programs, U.S. Nuclear Regulatory 
Commission, Washington, DC 20555-0001, telephone (301) 415-2347, e-mail 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Summary and Background

    The purpose of this final rule is to amend the Commission's 
regulations at 10 CFR part 110, ``Export and Import of Nuclear 
Equipment and Material,'' to implement sections 630, 651(d), and 651(e) 
of the energy Policy Act of 2005 (EPAct), which was signed into law on 
August 8, 2005.
    Section 630, ``Medical Isotope Production,'' of the EPAct, amended 
section 134 of the Atomic Energy Act of 1954, as amended (AEA), to 
facilitate the timely export to a ``Recipient Country'' of high-
enriched uranium (HEU) for medical isotope production in reactors that 
are either utilizing low-enriched uranium (LEU) fuel or have agreed to 
convert to the use of LEU fuel. A ``Recipient Country'' is defined in 
section 630 as Canada, Belgium, France, Germany, and the Netherlands. 
The EPAct also requires the Commission to review and impose, via 
license conditions or other appropriate means, physical protection 
requirements that are applicable to the transportation and storage of 
HEU for medical isotope production or control of residual material 
after irradiation and extraction of medical isotopes.
    Specifically, before issuing licenses authorizing the export of HEU 
in the form of fuel or targets for the production of medical isotopes 
to Canada, Belgium, France, Germany, and the Netherlands, the 
Commission must find that the Recipient Country has provided the United 
States with written assurances that any intermediate consignees and the 
ultimate consignee specified in the export application are required to 
use the HEU solely to produce medical isotopes. Further, the Commission 
must determine that the HEU will be irradiated in a reactor in a 
Recipient Country that uses an alternative nuclear reactor fuel, e.g., 
LEU, or is the subject of an agreement with the U.S. to convert to an 
alternative nuclear fuel when that fuel can be used in the reactor.
    Section 630 suspends for the Recipient Countries (until the 
Secretary of Energy makes certain findings) the portions of section 134 
of the AEA that required the Commission to make certain findings with 
respect to the use of LEU targets to produce medical isotopes before 
issuing an export license for HEU for medical isotope production.
    This final rule amends Sec.  110.42(a)(9) to reflect the revised 
export criteria with regard to export applications to Recipient 
Countries for medical isotope production. Although the implementing 
regulations promulgated will not take effect until August 7, 2006, NRC 
export licensing decisions have been governed by section 134 of the 
AEA, as amended by section 630 of the EPAct, since August 8, 2005. The 
NRC already evaluates the adequacy of the proposed physical protection 
measures under Sec.  110.42(a)(3) when it evaluates individual export 
license applications, and has the authority to impose additional 
requirements in the license as the Commission deems necessary. 
Therefore, no rule changes are necessary to implement the statutory 
provision.
    Section 651(d), ``Radiation Source Protection,'' of the EPAct 
amended the AEA by imposing new requirements pertaining to the export 
or import of Category 1 or Category 2 radiation sources as defined by 
the International Atomic Energy Agency (IAEA) Code of Conduct on the 
Safety and Security of Radioactive Sources (Code of Conduct) (and any 
other material that poses a threat, as determined by the Commission, 
other than spent nuclear fuel and special nuclear materials). The Code 
of Conduct includes sixteen categories of byproduct material sources, 
including radium-226. On July 1, 2005 (70 FR 37985), the Commission 
issued final regulations amending part 110 that together with other 
existing regulations satisfy the requirements of section 651(d) for the 
export and import of radioactive sources. However, at the time the July 
2005 rule was issued, the Commission did not have authority to regulate 
radium-226; therefore, radium-226 was not listed in Appendix P to part 
110 or covered by the scope for the July 2005 rule. The Commission 
provided notice that radium-226 would be added to Appendix P to part 
110, consistent with the Code of Conduct, if Congress conferred upon 
the Commission jurisdiction over radium-226. Section 651(e) of the 
EPAct amended the definition of byproduct material in section 11e. of 
the AEA to include discrete sources of radium-226. Consistent with the 
notice provided in the July 2005 rule and the authority conferred upon 
the Commission by Congress in section 651(e) of the EPAct, this rule 
amends Appendix P to include Category 1 and Category 2 quantities of 
discrete sources of radium-226.
    Section 651(e) of the EPAct amends section 11e. of the AEA to place 
accelerator-produced material, discrete sources of radium-226, and 
certain discrete sources of naturally-occurring radioactive material, 
other than source material, under NRC regulatory authority if produced, 
extracted, or converted for use in commercial, medical, or research 
activities. This rule amends Appendix L to part 110, ``Illustrative 
List of Byproduct Materials under NRC Export/Import Licensing 
Authority,'' to include discrete sources of radium-226 and accelerator-
produced radioactive material. Prior to the enactment of the EPAct, the 
Department of Commerce (DOC) had jurisdiction over the export of 
radium-226. As provided by the EPAct, discrete sources of radium-226 
will fall under NRC's jurisdiction; however, jurisdiction over the 
export of non-discrete sources of radium-226 will remain in DOC's 
jurisdiction. The Commission intends to define the term ``discrete 
source'' in a separate rulemaking.

Waiver of Notice and Comment Requirement

    This rule revises the Commission's regulations solely to 
incorporate provisions pertaining to the export and import licensing 
included in the EPAct. This rule tracks statutory provisions and the 
drafting of it did not involve the exercise of discretionary decision-
making. Good cause exists under 5 U.S.C. 553(b)(3)(B) to publish this 
final rule without soliciting public comment because public comment 
under these circumstances would serve no useful purpose and therefore, 
is unnecessary and contrary to the public interest.

Effective Date of Rule and Expiration of Time-Limited Waiver

    The effective date of this rule, August 7, 2006, coincides with the 
expiration of a time-limited waiver pertaining to NRC regulation of the 
import and export of the new categories of byproduct material added to 
AEA section 11e. by the EPAct. See Energy Policy Act of 2005 
Requirements; Treatment of Accelerator-Produced and other Radioactive 
Material as Byproduct

[[Page 20338]]

Material; Waiver, 70 FR 51581 (August 31, 2005).
    The NRC has determined that this rule will pose no unreasonable 
risk to the public health and safety or the common defense and 
security.

II. Section by Section Analysis of Substantive Changes

Subpart A--General Provisions

    Section 110.2. The definition of ``byproduct material'' has been 
revised to be consistent with section 651(e)(1) of the EPAct which 
amended the definition of byproduct material in section 11e. of the AEA 
to place accelerator-produced material, discrete sources of radium-226, 
and certain discrete sources of naturally occurring radioactive 
material, other than source material, under NRC regulatory authority if 
they are produced, extracted, or converted for use in commercial, 
medical, or research activities.
    The terms ``medical isotope,'' ``radiopharmaceutical,'' and 
``Recipient Country'' have been added to this section consistent with 
the section 630 of the EPAct which amended section 134 of the AEA.

Subpart D--Review of License Applications

    Section 110.42. A new paragraph (a)(9) is amended to incorporate 
the requirements set forth in section 630 of the EPAct regarding 
medical isotope production.
    Appendix L to Part 110--Illustrative List of Byproduct Materials 
Under NRC Export/Import Licensing Authority. The list of byproduct 
material in Appendix L is amended to add radium-226. Under the EPAct, 
the definition of byproduct material was expanded to include discrete 
sources of radium-226. The import or export of discrete sources of 
radium-226 that are below the threshold limits for radium-226 listed in 
Appendix P to part 110 may be accomplished through a general license 
set forth in 10 CFR 110.23. In addition, a footnote is added to 
Appendix L to indicate that the NRC has import and export authority 
over any accelerator-produced material that was produced, extracted or 
converted for use for a commerical medical, or research activity. A 
second footnote is added to Appendix L to indicate that NRC has import 
and export authority or discrete sources of radium-226.

Appendix P to Part 110--Category 1 and 2 Radioactive Material

Table 1.--Import and Export Threshold Limits

    The list of category 1 and 2 radioactive material in Appendix P is 
amended to add radium-226 and the corresponding threshold limits for 
Category 1 and 2 quantities consistent with the values in Table 1 of 
the IAEA Code of Conduct. A specific license is required for the import 
or export of discrete sources of radium-226 meeting the threshold 
quantities listed in Table 1 of Appendix P. A footnote is added to the 
list in Appendix P to indicate that the NRC has import and export 
authority over discrete sources of radium-226.

Voluntary Consensus Standards

    The National Technology Transfer and Advancement Act of 1995 (Pub. 
L. 104-113). requires that Federal Agencies use technical standards 
that are developed or adopted by voluntary consensus standards bodies 
unless using such a standard is inconsistent with applicable law or 
otherwise impractical. This final rule does not constitute the 
establishment of a standard for which the use of a voluntary consensus 
standard would be applicable.

Environmental Impact: Categorical Exclusion

    The NRC has determined that this final rule is type of action 
described in categorical exclusion 10 CFR 51.22(c)(1). Therefore, 
neither an environmental impact statement nor an environmental 
assessment has been prepared for this final rule.

Paperwork Reduction Act Statement

    This final rule implements the provisions of the Energy Policy Act 
of 2005, sections 630, 651(d), and 651(e). The final rule does not 
impact the information collection burden for 10 CFR part 110 licensees. 
Any burden for licensing actions would be against NRC Form 7 (3150-
0027). However, few, if any, licensing actions are expected to be 
submitted. Because the burden for this information collection is 
insignificant, Office of Management and Budget (OMB) clearance is not 
required. Existing requirements were approved by the OMB, approval 
number 3150-0036.

Public Protection Notification

    The NRC may not conduct or sponsor, and a person is not required to 
respond to, a request for information or any information collection 
requirement unless the requesting document displays a currently valid 
OMB control number.

Regulatory Analysis

    The EPAct, which was signed into law on August 8, 2005, amended the 
definition of byproduct material in the Atomic Energy Act of 1954, as 
amended to include discrete sources of radium-226 and conferred 
regulatory authority of it to the NRC. Previously, radium-226 was under 
the jurisdiction of the U.S. Department of Commerce. The NRC is 
amending its regulations at 10 CFR part 110 to add radium-226 to the 
list of radioactive material in Appendix P to part 110. Shipments of 
radium-226 at or above the Category 2 level will require a specific 
license. This change to part 110 fulfills the mandate from Congress in 
section 651(d) and (e) of the EPAct and with the IAEA Code of Conduct. 
Additionally, to implement section 630, ``Medical Isotope Production,'' 
of the EPAct, this final rule amends 10 CFR 110.42, ``Export licensing 
criteria.'' There is no alternative to amending the regulations at 10 
CFR part 110 to reflect changes in law. This final rule is expected to 
have an insignificant increase in the information collection burden and 
cost to the public for applications to export or import radium-226 at 
the quantities listed in Appendix P to part 110.

Backfit Analysis

    The NRC has determined that a backfit analysis is not required for 
this rule because these amendments do not include any provisions that 
would impose backfits as defined in 10 CFR Chapter I.

Congressional Review Act

    Under the Congressional Review Act of 1996, the NRC has determined 
that this action is not a major rule and has verified this 
determination with the Office of Information and Regulatory Affairs of 
OMB.

List of Subjects in 10 CFR Part 110

    Administrative practice and procedure, Classified information, 
Criminal penalties, Export, Import, Intergovernmental relations, 
Nuclear materials, Nuclear power plants and reactors, Reporting and 
recordkeeping requirements, Scientific equipment.


0
For the reasons set out in the premble and under the authority of the 
Atomic Energy Act of 1954, as amended; the Energy Reorganization Act of 
1974, as amended; and 5 U.S.C. 552 and 553; the NRC is adopting the 
following amendments to 10 CFR part 110.

[[Page 20339]]

PART 110--EXPORT AND IMPORT OF NUCLEAR EQUIPMENT AND MATERIAL

0
1. The authority citation for part 110 is revised to read as follows:

    Authority: Secs. 51, 53, 54, 57, 63, 64, 65, 81, 82, 103, 104, 
109, 111, 126, 127, 128, 129, 134, 161, 170H., 181, 182, 187, 189, 
68 Stat. 929, 930, 931, 932, 933, 936, 937, 948, 953, 954, 955, 956, 
as amended (42 U.S.C. 2071, 2073, 2074, 2077, 2092-2095, 2111, 2112, 
2133, 2134, 2139, 2139a, 2141, 2154-2158, 2160d., 2201, 2210h., 
2231-2233, 2237, 2239); sec. 201, 88 Stat. 1242, as amended (42 
U.S.C. 5841; sec. 5, Pub. L. 101-575, 104 Stat. 2835 (42 U.S.C. 
2243); sec. 1704, 112 Stat. 2750 (44 U.S.C. 3504 note).
    Sections 110.1(b)(2) and 110.1(b)(3) also issued under Pub. L. 
96-92, 93 Stat. 710 (22 U.S.C. 2403). Section 110.11 also issued 
under sec. 122, 68 Stat. 939 (42 U.S.C. 2152) and secs. 54c and 57d, 
88 Stat. 473, 475 (42 U.S.C. 2074). Section 110.27 also issued under 
sec. 309(a), Pub. L. 99-440. Section 110.50(b)(3) also issued under 
sec. 123, 92 Stat. 142 (42 U.S.C. 2153). Section 110.51 also issued 
under sec. 184, 68 Stat. 954, as amended (42 U.S.C. 2234). Section 
110.52 also issued under sec. 186, 68 Stat. 955 (42 U.S.C. 2236). 
Sections 110.80-110.113 also issued under 5 U.S.C. 552, 554. 
Sections 110.30-110.135 also issued under 5 U.S.C. 553. Sections 
110.2 and 110.42(a)(9) also issued under sec. 903, Pub. L. 102-496 
(42 U.S.C. 2151 et seq.).


0
2. In Sec.  110.2, the definition of Byproduct material is revised, and 
definitions for Medical isotope, Radiopharmaceutical, and Recipient 
Country are added in alphabetical order to read as follows:


Sec.  110.2  Definitions.

* * * * *
    Byproduct material means
    (1) Any radioactive material (except special nuclear material) 
yielded in, or made radioactive by, exposure to the radiation incident 
to the process of producing or utilizing special nuclear material;
    (2) The tailings or wastes produced by the extraction or 
concentration of uranium or thorium from ore (see 10 CFR 20.1003);
    (3)(i) Any discrete source of radium-226 that is produced, 
extracted, or converted after extraction, before, on, or after August 
8, 2005, for use for a commercial, medical, or research activity; or
    (ii) Any material that has been made radioactive by use of a 
particle accelerator and is produced, extracted, or converted after 
extraction, before, on, or after August 8, 2005 for use for a 
commercial, medical, or research activity; and
    (4) Any discrete source of naturally occurring radioactive 
material, other than source material, that--
    (i) The Commission, in consultation with the Administrator of the 
Environmental Protection Agency, the Secretary of Energy, the Secretary 
of Homeland Security, and the head of any other appropriate Federal 
agency, determines would pose a threat similar to the threat posed by a 
discrete source of radium-226 to the public health and safety or the 
common defense and security; and
    (ii) Before, on, or after August 8, 2005 is extracted or converted 
after extraction for use in a commercial, medical, or research 
activity.
* * * * *
    Medical isotope, for the purposes of Sec.  110.42(a)(10), 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
* * * * *
    Radiopharmaceutical, for the purposes of Sec.  110.42(a)(10), means 
a radioactive isotope that contains byproduct material combined with 
chemical or biological material and is designed to accumulate 
temporarily in a part of the body for therapeutic purposes or for 
enabling the production of a useful image for use in a diagnosis of a 
medical condition.
     Recipient Country, for the purposes of Sec.  110.42(a)(10), means 
Canada, Belgium, France, Germany, and the Netherlands.
* * * * *

0
3. In Sec.  110.42, paragraph (a)(9)(i) is revised, paragraph 
(a)(9)(ii) is redesignated as paragraph (a)(9)(iii), and new paragraph 
(a)(9)(ii) is added to read as follows:


Sec.  110.42  Export licensing criteria.

    (a) * * *
    (9)(i) Except as provided in paragraph (a)(9)(ii) of this section, 
exports of high-enriched uranium to be used as a fuel or target in a 
nuclear research or test reactor, the Commission determines that:
    (A) There is no alternative nuclear reactor fuel or tart enriched 
to less than 20 percent in the isotope U-235 that can be used in that 
reactor;
    (B) The proposed recipient of the uranium has provided assurances 
that, whenever an alternative nuclear reactor fuel or target can be 
used in that reactor, it will use that alternative fuel or target in 
lieu of highly-enriched uranium; and
    (C) The United States Government is actively developing an 
alternative nuclear reactor fuel or target that can be used in that 
reactor.
    (ii) With regard to a Recipient Country, the Commission may issue a 
license authorizing the export of high-enriched uranium for medical 
isotope production, including shipment to and use at intermediate and 
ultimate consignees, if the Commission determines that:
    (A) The Recipient Country has supplied 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 export license application are required to 
use the high-enriched uranium solely for the production of medical 
isotopes; and
    (B) The high-enriched uranium will be irradiated only in a reactor 
in the Recipient Country that--
    (1) Uses an alternative nuclear fuel; or
    (2) 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.
* * * * *
0
4. Appendix L to part 110 is amended by adding new footnote a to the 
title of Appendix L, by amending the list of byproduct material by 
adding ``Radium-226 (Ra 226)'' in alphabetical order, and by adding new 
footnote b to read as follows:

Appendix L to Part 110--Illustrative List of Byproduct Materials Under 
NRC Export/Import Licensing Authority \a\
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    \a\ Any accelerator-produced material produced, extracted, or 
converted for use for a commercial, medical, or research activity.
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* * * * *

Radium-226 (Ra-226) \b\
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    \b\ Discrete sources of radium-226 (Ra-226).
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* * * * *

0
5. Appendix P to part 110 is amended by adding ``Radium-226'' in 
alphabetical order to Table 1. and new footnote a to read as follows:

Appendix P to Part 110--High Risk Radioactive Material

[[Page 20340]]



                                  Table 1.--Import and Export Threshold Limits
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                                                         Category 1                        Category 2
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            Radioactive material               Terabequerels                     Terabequerels
                                                   (TBq)         Curies  (Ci)        (TBq)         Curies  (Ci)
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                                                  * * * * * * *
Radium-226 \a\..............................              40            1,100              0.4               11
 
                                                  * * * * * * *
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\a\ Discrete sources of radium-226.


    Dated at Rockville, Maryland, this 4th day of April, 2006.

    For the Nuclear Regulatory Commission.
Luis A. Reyes,
Executive Director for Operations.
[FR Doc. 06-3664 Filed 4-17-06; 8:45 am]
BILLING CODE 7590-01-M