[Federal Register Volume 70, Number 126 (Friday, July 1, 2005)]
[Rules and Regulations]
[Pages 37985-37994]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-12985]



 ========================================================================
 Rules and Regulations
                                                 Federal Register
 ________________________________________________________________________
 
 This section of the FEDERAL REGISTER contains regulatory documents 
 having general applicability and legal effect, most of which are keyed 
 to and codified in the Code of Federal Regulations, which is published 
 under 50 titles pursuant to 44 U.S.C. 1510.
 
 The Code of Federal Regulations is sold by the Superintendent of Documents. 
 Prices of new books are listed in the first FEDERAL REGISTER issue of each 
 week.
 
 ========================================================================
 

  Federal Register / Vol. 70, No. 126 / Friday, July 1, 2005 / Rules 
and Regulations  

[[Page 37985]]



NUCLEAR REGULATORY COMMISSION

10 CFR Part 110

RIN 3150-AH44


Export and Import of Radioactive Materials: Security Policies

AGENCY: Nuclear Regulatory Commission.

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: The Nuclear Regulatory Commission (NRC) is amending its 
regulations pertaining to the export and import of radioactive 
materials. The amendments implement recent changes to the nuclear and 
radioactive material security policies of both the Commission and the 
Executive Branch. The final rule takes into account provisions in the 
International Atomic Energy Agency (IAEA) Code of Conduct on the Safety 
and Security of Radioactive Sources (Code of Conduct) concerning the 
import and export of radioactive sources, and the supplemental IAEA 
Guidance on the Import and Export of Radioactive Sources (Guidance 
document) on internationally harmonized guidance for the import and 
export of radioactive sources. The amendments provide for enhanced 
tracking of certain exports and imports of radioactive sealed sources 
and bulk material for certain radionuclides. The amended regulation 
includes new specific export and import license requirements, advance 
notification procedures prior to shipment, verification of the 
recipient facility's licensing status, and review of the adequacy of 
the receiving country's controls on radioactive sources. The amendments 
apply to a small number of radioactive materials when exported or 
imported in amounts exceeding clearly defined International System (SI) 
limits. The amended regulation provides the Commission with flexibility 
to treat each export and import license application on a case-by-case 
basis, with the ability to accommodate the still evolving domestic and 
international security measures for radioactive material.

DATES: This final rule becomes effective on December 28, 2005, to allow 
a period of six months for exporters and importers to apply for and 
receive required specific export and import licenses.

ADDRESSES: Copies of the final rule, the regulatory analysis, public 
comments received and related documents may be examined on public 
computers and copied for a fee 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/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.llnl.gov. Address questions 
about our rulemaking Web site to Carol Gallagher (301) 415-5905; e-
mail: [email protected].

FOR FURTHER INFORMATION CONTACT: Suzanne Schuyler-Hayes, Office of 
International Programs, U.S. Nuclear Regulatory Commission, Washington, 
DC 20555-0001, telephone (301) 415-2333, e-mail: [email protected].

SUPPLEMENTARY INFORMATION:

I. Background and Summary

    On September 16, 2004, the NRC published in the Federal Register a 
proposed rule that would amend 10 CFR part 110 pertaining to the export 
and import of nuclear material and equipment (69 FR 55785). The NRC is 
now issuing a final rule based on the comments received on the proposed 
rule. This final rule takes into account the results of the NRC's 
comprehensive review of nuclear and radioactive material security 
requirements in the post-September 11, 2001 environment and the 
resulting Orders issued to domestic licensees of the NRC and Agreement 
States under the Commission's authority under the Atomic Energy Act of 
1954, as amended (AEA), to assure the common defense and security. The 
Orders are separate from this rulemaking and remain in effect for 
domestic shipments. The final rule codifies provisions in the 
International Atomic Energy Agency (IAEA) Code of Conduct on the Safety 
and Security of Radioactive Sources (Code of Conduct) for the import 
and export of radioactive material, and the supplemental IAEA Guidance 
on the Import and Export of Radioactive Sources (Guidance document). 
Paragraphs 23-29 of the Code of Conduct are intended to guide countries 
in the development and harmonization of policies and laws on certain 
exports and imports of radioactive sources, which if handled 
improperly, may pose a significant risk to individuals, society and the 
environment, to ensure that such sources are only exported to 
authorized end-users in countries with adequate regulatory controls, 
and that they are not diverted for illicit use. The U.S. and many other 
countries have politically committed to follow the Guidance contained 
in the Code of Conduct and Guidance document, which were each approved 
by the IAEA Board of Governors in 2003 and endorsed by the IAEA General 
Conference in 2004. The final rule also goes beyond the Code of Conduct 
and its Guidance document in the area of bulk material to reflect the 
post September 11, 2001 security policies of the Commission and the 
Executive Branch. Material in ``bulk'' or ``loose'' form raises 
security concerns that equal or exceed those for material in sealed 
sources.
    The specific radioactive material and quantities that will be 
covered by this final rule are listed in Table 1 of the new Appendix P 
to part 110. Table 1 is essentially identical to the list of 
radioactive materials in Categories 1 and 2 in Annex 1, Table 1, of the 
Code of Conduct. The amendments to part 110 require NRC authorization 
of certain exports and imports by specific license of radioactive 
material at the Category 2 level and above of the IAEA Code of Conduct 
and the Guidance document which may pose a significant risk to 
individuals, society and the

[[Page 37986]]

environment if handled improperly. Exports and imports of these 
radioactive materials will take place with prior notification to the 
NRC and the importing country authority. Exports of Category 1 
quantities of such material will require the consent of the government 
of the importing country prior to shipment.\1\ While prior notification 
of the importing government authority may originate from either the 
exporting licensee or exporting government authority, consent to the 
import of Category 1 material is to be provided on a government to 
government basis. The NRC will not issue a license for Category 1 
exports prior to receiving consent from the importing government. In 
cases where the recipient does not have an authorization to possess the 
radioactive material and/or the importing country does not have the 
technical and administrative capability, resources, and regulatory 
structure needed to ensure that the radioactive source will be managed 
in a manner consistent with the provisions of the Code of Conduct, the 
NRC may, at its discretion, authorize an export of Category 1 and 2 
radioactive material in cases of exceptional circumstances, as defined 
in Sec.  110.2. Category 1 and 2 exports will not be permitted under 
exceptional circumstances unless the government of the importing state 
provides its consent to the United States Government for the import.
---------------------------------------------------------------------------

    \1\ The more restrictive requirements for the export of 
plutonium 238 and 239 contained in Sec.  110.21 will continue to be 
the limiting controls.
---------------------------------------------------------------------------

    Although the provision for ``exceptional circumstances'' in the 
Guidance document applies to both imports and exports, this final rule 
will only address such circumstances as they apply to exports. This is 
because the U.S. has the technical and administrative capability, 
resources and regulatory structure needed to ensure that radioactive 
sources will be managed in the United States in a manner consistent 
with the provisions of the Code of Conduct, and to ensure that the 
domestic recipient is authorized to receive and possess the source 
under U.S. national law.
    With the exception of plutonium, the radioactive materials listed 
in Appendix P, Table 1, are categorized as byproduct material as 
defined in the AEA. Although radium-226 is encompassed by the Code of 
Conduct, it is not listed in Appendix P, Table 1, or covered by the 
scope of this final rule because, as a naturally occurring radioactive 
material, under the AEA, it is not under the jurisdiction of the NRC. 
The Department of Commerce regulates the export of radium-226. The NRC 
is seeking legislation from Congress that will confer upon it licensing 
jurisdiction over discrete sources of radium-226. Should that 
legislation be enacted, the NRC will amend its export and import 
regulations in a manner consistent with the Code.
    It should be noted that yttrium-90 has been added to Appendix P, 
Table 1, as a decay product of strontium-90, consistent with Annex 1, 
Table 1 of the Code of Conduct. Also, the final rule makes clear that 
the threshold amounts in Table 1 are specified by terabequerels (TBq). 
Curie values are provided by NRC for informational purposes only, since 
the values have been rounded after conversion. Any conversion to the 
curie must still meet the TBq limit. Appendix P also prescribes the 
methodology, ``sum of fractions,'' to be used for calculating the 
shipment of bulk material and/or multiple radionuclides. This 
methodology is used in 10 CFR part 71, Appendix A, for calculating the 
transport of multiple radionuclides. The requirements described in this 
final rule apply to all identified licensees, both NRC and Agreement 
State.
    Consistent with the scope of part 110, this rule does not apply to 
the Departments of Defense and Energy for activities authorized by 
sections 54, 64, 82 and 91 of the AEA, except when the Department of 
Energy seeks an export license under section 111 of the AEA (see Sec.  
110.1(b)(1)). In addition, paragraph F.5 of the Guidance document notes 
that ``States should construe this non-legally binding Guidance in 
accordance with activities furthering non-proliferation, nuclear 
security, and the avoidance of malicious acts using radioactive 
sources.''
    Exports. Under the AEA and 10 CFR part 110, the principal criterion 
for approving exports of the materials listed in Appendix P is a 
finding that the export is not inimical to the common defense and 
security of the United States. The non-inimicality finding is relevant 
to both the nuclear proliferation significance of exports and the 
related security concerns about radioactive material falling into the 
hands of non-country organizations, including terrorist groups. In 
making its inimicality determination, the Commission will, under the 
rule and consistent with the Guidance document, and in consultation 
with the Executive Branch, consider whether the importing country has 
the technical and administrative capability and the resources and 
regulatory structure to manage the radioactive material in a safe and 
secure manner, and has authorized the recipient to receive and possess 
this material. For proposed exports of Category 1 amounts of 
radioactive material listed in Appendix P, the Commission will also 
assess whether the government of the importing country has provided its 
consent to the import. For both Category 1 and Category 2 exports, the 
Commission will require the applicant for the export license to provide 
the NRC with pertinent documentation demonstrating that the recipient 
of the radioactive material has the necessary authorization under the 
laws and regulations of the importing country to receive and possess 
the material.
    The Code of Conduct and the Guidance document provide for exports 
and imports in situations where a potential recipient lacks the 
necessary authorization to receive and possess the radioactive 
material, or where a receiving country is lacking in technical and 
administrative capability, resources, or regulatory structure, under 
``exceptional circumstances.'' The Commission has considered that 
guidance in preparation of this final rule, and therefore will consider 
as part of its overall inimicality determination whether the export 
qualifies as an ``exceptional circumstance.'' In such a case, the 
Commission will also consider whether the government of the importing 
country has provided its consent to the import of Category 1 or 
Category 2 amounts of radioactive material.
    In examining these and other factors that may be pertinent to 
assessing whether the proposed export will be inimical to the U.S. 
common defense and security, the Commission will, as appropriate, seek 
the advice of the Executive Branch and will take into account 
information it receives as part of regular interactions with its 
foreign regulatory counterparts, the IAEA, and the Executive Branch. 
If, after considering the above information, the Commission authorizes 
the export, then export licensees will be required to provide prior 
notification of individual shipments to the importing country authority 
and to the NRC.
    Imports. For imports, the licensing criteria are non-inimicality to 
the U.S. common defense and security and a finding that the import does 
not constitute an unreasonable risk to the public health and safety. 
The final rule incorporates the Guidance document's criteria for making 
these determinations. Since all recipients in the U.S. must be properly 
authorized by the NRC, an Agreement State, or the Department of Energy 
to receive and possess such

[[Page 37987]]

radioactive material, import licenses under NRC's licensing authority 
of radioactive material will simply require that the recipient licensee 
provide (1) a copy of its authorization to the exporter or exporting 
country authority (or alternatively that the NRC confirm to the 
exporting country's authority that the U.S. recipient is authorized to 
receive and possess the radioactive material), (2) prior notification 
to the NRC of individual shipments, and (3) pertinent documentation to 
the NRC that each recipient of the radioactive material has the 
necessary authorization to possess this material. For proposed imports 
into the U.S. of Category 1 amounts of radioactive material, specified 
in Appendix P to Part 110, the Commission will be responsible for 
providing the necessary formal U.S. Government consent to the export 
authority of the exporting country.
    Flexibility. The Commission will evaluate each license application 
on a case-by-case basis, but may exercise some discretion on whether a 
license may cover multiple shipments. For example, the Commission may 
wish to limit exports made to new recipients or to a country/
destination with limited experience with its regulatory infrastructure 
to single shipments of radioactive material. On the other hand, for 
countries with mature regulatory infrastructures with known and 
competent recipients, the Commission intends to use the provisions of 
Sec.  110.31(e) to issue broad specific export and import licenses for 
multiple radionuclides, shipments, and destinations and with 
authorizations valid for multiple years. The duration of the import or 
export authorization will be consistent with the expiration date of the 
recipient's authorization to receive and possess the radioactive 
material. In all cases, each shipment will require prior notification 
as discussed previously.

II. Comments on the Proposed Rule

    On October 19, 2004, the staff held a public meeting at NRC to 
answer questions and address concerns about the proposed rule and how 
it would be implemented. A summary of the October 2004 public meeting 
and a list of questions and answers prepared by the NRC staff for 
discussion at the public meeting, are available on the NRC's rulemaking 
Web site at http://ruleforum.llnl.gov (ADAMS accession nos. ML043020582 
and ML042930012, respectively). Another public meeting was held on 
February 16, 2005.
    Written comments on the proposed rule were due to the NRC by 
November 30, 2004. The Commission received eighteen letters from the 
public commenting on the proposed rule. In general, the comments 
received related either to the scope of the rule or the effect of its 
implementation on licensees, from the potential for disruption of 
supply to the cost of fees required to obtain the new licenses that 
would be required.
    Comment: With regard to comments on the scope of the proposed rule, 
several private individuals indicated that it is not broad enough 
because it does not address radiological safety or fully address 
security concerns due to the basic international decision to limit 
government imposed controls to exports and imports of Category 1 and 2 
material, leaving Category 3 material uncontrolled.
    For Category 3 material, comments suggested that the Commission 
should do three things: (1) Modify the current general export license 
by requiring the exporter to notify the NRC in advance of each 
shipment, (2) require that all exports under the general license be to 
specific end-users whose bona fides have been verified, and (3) 
differentiate among Category 3 exports by establishing subcategories of 
specific concern and authorizing exports under the general license to a 
limited number of countries.
    Commenters also indicated that the final rule should require 
shipments of radioactive sources, and the devices containing them, to 
comply with standards for radiation safety and when applicable, for 
patient safety, prior to export. It should also require date and 
confirmation of receipt by the intended recipients of the radioactive 
sources scheduled for export, in order to complete the security linkage 
governing transfers.
    NRC Response: While it is conceivable that additional security 
measures for Category 3 material are possible in the future, an attempt 
to achieve such enhanced controls would extensively delay the 
implementation of the final rule. At this time, there is no 
international export/import guidance relating to Category 3 sources. 
This issue was discussed at length during the meetings sponsored by the 
IAEA which led to the adoption of the Code of Conduct and the Guidance 
document. Balancing security and the need to provide a reliable and 
commercially viable radioactive source industry, the involved countries 
decided to limit internationally harmonized export/import controls to 
Category 1 and 2 sources. In so doing, the involved countries 
recognized the need for proper security for Category 3 sources, but 
concluded that such security measures could be adequately addressed by 
a combination of domestic safety/security regulatory oversight and by 
recognizing the overall competence of the radioactive source industry. 
Providing additional government authority over such material, without 
clear indications of wider government and industry support for such 
measures, would likely be counterproductive and harm the larger public 
interest by impeding international commerce in the use of Category 3 
sources.
    Confirmation of receipt by the intended recipients of the 
radioactive sources scheduled for export, in order to complete the 
security linkage governing transfers, is required in the recipient's 
certification to the licensee.
    Comment: Several comments from industry indicated that the scope of 
the proposed rule should be relaxed for certain exports and imports 
being placed under specific license requirements to avoid potential 
supply disruptions. One commenter requested that exports of smoke 
detectors containing less than one microcurie of americium-241 be 
exempted from Part 110 licensing, and if this is not possible that it 
be exempted from specific license and the reporting requirements as 
listed in Sec.  110.23(b). Several commenters requested that instead of 
requiring a specific license, that the following be allowed under 
general license: exports and imports of americium-241 and AmBe 
contained in industrial process control equipment or petroleum 
exploration equipment, to any country not listed in Sec.  110.28 
(embargoed destinations); the return or import of used sources to the 
U.S. exporter; the use of end-user statements instead of specific 
licenses; and the use by exporters/shippers of local quality assurance 
procedures to validate the legitimacy of the end user using standard 
business practices in accordance with already existing Customs 
requirements. Commenters suggested that, for Category 2 shipments, the 
regulations should allow e-mail notifications to NRC at the time of 
shipment, currently done under the Commission's Orders; and for 
Category 2 exports, the owner or licensee should be able to determine 
if the foreign recipient is properly authorized to receive material 
which is authorized by the Code of Conduct Guidance. Finally, it was 
suggested that the IAEA standard should be used for verifying 
suitability of an importing country instead of redundant assessments by 
multiple countries. In connection with this, the NRC should provide a 
list of countries which meet the suitability requirements.

[[Page 37988]]

    NRC Response: While NRC is not excluding such byproduct material 
from Part 110 coverage, essentially all such exports are covered by the 
general licenses in Sec.  110.23(a). Also, the reporting requirement 
for americium-241 in Sec.  110.23(b) must remain due to a commitment 
among the U.S. Government and the governments of the United Kingdom, 
France, the Russian Federation and Japan to exchange annual reports of 
americium-241 and neptunium-237 as alternate nuclear materials.''
    With regard to comments that favored the control of Category 2 
shipments under the general license in Sec.  110.23(a), the Commission 
has determined that its security policy for the export and import of 
Appendix P radioactive material will require specific export and import 
licenses, including Category 2 shipments.
    In response to the Commission's requirement of export and import 
licenses, and the public's view that they will cause supply 
disruptions, NRC will employ a series of steps to prevent this scenario 
from developing. First, the NRC will issue specific licenses that are 
carefully crafted and contain appropriate conditions. Second, licenses 
can be issued for broad periods of time to multiple destinations. 
Third, staff resources in the Office of International Programs that 
were used in the development of this rule will be devoted to 
implementing it and reviewing the export and import license 
applications so that licenses can be issued on a timely basis. Fourth, 
to the extent possible, the NRC and Executive Branch will consider 
information from the importing countries, the IAEA, and other sources 
when deciding on whether to license an export to an importing country. 
Because there is no single set of criteria to determine whether an 
importing country has adequate regulatory controls, this assessment in 
most cases will rely on multiple sources of information. In that 
regard, the Commission plans to (1) initiate contacts with NRC's 
foreign regulatory counterparts in key countries in an effort to obtain 
information on their capabilities in handling Appendix P radioactive 
material, and (2) obtain any publicly available information from the 
IAEA. Fifth, during the early stages of rule implementation, the 
Commission will rely on its authority to issue specific export licenses 
under the ``exceptional circumstances'' clause (as reflected in Sec.  
110.42(e)(3)), where appropriate, in order to avoid serious supply 
disruptions while at the same time being mindful of security concerns.
    Comment: Several commenters indicated that the scope of the NRC 
proposed rule does not conform to the Code of Conduct because (1) it 
includes bulk material; (2) the threshold value or regulatory standard 
needs to be in metric units, or U.S. shipments will exceed 
international standards; (3) it requires a specific license instead of 
an authorization; and (4) the notification requirement is 10 days 
instead of 7. Other commenters were concerned as to the conformance of 
the export/import rule with domestic transportation regulations.
    NRC Response: The Commission believes that shipments of bulk 
material need to be within the scope of this rule in the new security 
environment. While international guidance does not as yet cover such 
exports or imports, NRC does not anticipate any difficulty in the 
timely processing of such export or import requests since they are less 
frequent (compared to radioactive source exports and imports) and each 
request can be handled on a case-by-case basis with appropriate 
interaction between NRC, the importing country and the importing 
facility owner or licensee.
    With regard to the regulatory standard, the final rule makes it 
clear that the threshold amounts in Table 1 of Appendix P are specified 
in the International System (SI) of weights and measures of TBq. Any 
conversion to curies must meet the SI or TBq limit. Therefore, curies 
cannot be rounded up if they violate that limit. Also, the 10-day prior 
notification period in the proposed rule in Sec.  110.50(b)(4), is 
being changed to 7 days in the final rule, in conformance with the 
Guidance document. With regard to possible conflicts in the domestic 
transport of radioactive materials, NRC is closely monitoring 
requirements in the transportation area to ensure that there is no 
conflict. Conversely, any security-related enhancements in the domestic 
area may impact the Commission's export/import regulations, not only as 
they pertain to Appendix P material, but also with respect to the NRC's 
standard provisions for handling other exports (such as source and 
special nuclear material). The NRC is working with other agencies and 
the international community to address the issue of possible 
discrepancies between this rule and any future transportation 
standards.
    Comment: Several comments concerned the potential cost of the many 
export and import licenses that would be required, and the cost of 
disrupting supply and commerce. Several commenters indicated that the 
NRC license fees are high and will drive some small companies out of 
business, because the fee and/or amendment request could prove more 
expensive than the source itself. They noted the lack of relief for 
small business entities. Additionally, commenters expressed concern 
that it would be necessary to apply for many NRC specific licenses for 
each foreign end user. A globally harmonized approach is needed to 
ensure a level playing field for commerce. Commenters argued that for 
radiography and oil well logging, particularly for producers and 
shippers of americium-241, AmBe, and iridium-192, a delay in receiving 
the source can jeopardize the project or critical safety inspections.
    A number of comments pointed to the specific license requirements 
in the proposed rule, suggesting these would adversely affect commerce 
in the following ways. First, the commenters noted the estimated burden 
of 15 minutes per advance notification is inaccurate, and is expected 
to take 30 minutes or more. Second, the commenters noted the 
requirement to list all foreign end users on each export license 
application, if required for each new foreign customer, would exceed 
NRC's domestic licensing regulations. Third, the commenters noted that 
new rule will require a potentially large number of licenses that will 
be required by the proposed rule, e.g., if a new license is required 
for each foreign end-user. Fourth, the commenters noted that there is a 
possible three- to four-month time period required to process each 
application which already exists with current part 110 procedures. 
Fifth, the commenters noted that there is uncertainty over whether a 
U.S. company doing business in another country will require a specific 
license that has been issued by the other country. Sixth, some 
countries issue import permits for each shipment, which could 
complicate the process of issuing the related NRC export license. 
Seventh, some countries may not be able to receive shipments from the 
U.S. because in that country the material is not regulated or there is 
no regulatory authority to implement the Code of Conduct.
    NRC Response: To alleviate some of the concerns about the costs of 
this rule, the Commission intends to issue broad specific licenses 
which will allow spreading the licensing fees over several shipments. 
With regard to the burden estimate for submitting advance notifications 
to the NRC prior to shipment, comments received from industry during 
the Public Meeting of October 19, 2004, indicated that the estimated 15 
minutes per advance

[[Page 37989]]

notification will take closer to 30 minutes each. Therefore, in the 
final rule, the estimated burden for each advance notification to the 
NRC by the licensee is being changed to 30 minutes. In Sec.  110.50 
paragraph (b)(4) of the proposed rule, advance notifications were due 
to the NRC at least 24 hours in advance of each shipment, and to the 
extent practical, 10 days in advance of each shipment, consistent with 
comments received by the Commission in the development of the 
Commission Additional Security Measures (ASMs). In the final rule, ``to 
the extent practical'' has been adjusted downward to 7 days for 
consistency with the Guidance document. Hence, although the final rule 
requires at least 24-hours advance notification prior to shipment, such 
notifications under Sec.  110.50(b)(4) are expected within 7 days, ``to 
the extent practical.'' Further, the U.S. is actively encouraging other 
countries to follow the Code of Conduct and Guidance document to 
harmonize import and export procedures. The NRC has the discretion to 
consider exceptional circumstances, defined in Sec.  110.2, if a 
country does not have the regulatory structure needed to ensure that 
radioactive sources will be managed in a manner consistent with the 
Code of Conduct.
    Comment: Several individuals indicated that the six-month 
implementation period is not long enough to provide adequate time for 
the U.S. and other governments to ensure that all end users are 
properly qualified and licensed to receive and possess the material. 
The commenters also pointed out that part 110 does not indicate what 
penalties are to be used to punish those countries which choose to 
violate NRC's regulations.
    NRC Response: NRC expects that the majority of new licenses 
required by the rule will be issued within the six-month period 
following its publication in the Federal Register, particularly to 
those entities in countries with known, competent nuclear regulatory 
systems. To address the issue of countries and/or end users that may 
have difficulty in meeting all the new requirements, the Commission can 
rely on certain ``exceptional circumstances,'' where present, as the 
basis for issuing export licenses.
    The penalties to be applied for violating NRC's export/import 
regulations are addressed in part 110, subpart F. The U.S. is actively 
encouraging other countries to follow the guidance in the Code of 
Conduct and Guidance document. It is to the advantage of all suppliers 
that the export and import procedures be applied in a harmonized manner 
to avoid undercutting and to help ensure a level playing field.

III. Section by Section Analysis of the Final Rule

    Section 110.2. A definition of ``exceptional circumstances'' 
consistent with the Code of Conduct and Guidance document is being 
added to the final rule. Also, the definition of ``specific activity'' 
is being revised in the final rule to reflect the TBq SI unit as the 
regulatory standard. This will make part 110 consistent with the 
Commission's 1996 metrication policy. Any conversion to curies must not 
exceed the TBq limit. New sources to be exported or imported under the 
general license will have to conform to the TBq limits by the time the 
final rule is implemented.
    Subpart C--Licenses. The final rule requires specific licenses for 
all exports and imports of radioactive material listed in Table 1 of 
the new Appendix P to part 110, if the shipment amounts meet or exceed 
those listed.
    Section 110.21. In paragraph (a)(4), the curie value is replaced by 
the SI unit of TBq to make Sec.  110.21 consistent with the SI units 
used in Appendix P.
    Section 110.22. In paragraph (a)(3), the curie value is replaced by 
the SI unit of TBq to make Sec.  110.22 consistent with the SI units 
used in Appendix P.
    Section 110.23. In paragraphs (a)(2), (3), (5), and (6) of this 
section, the curie and gram values are replaced by TBq to make these 
paragraphs consistent with the SI units used in Appendix P. In 
paragraph (a)(2), a sentence is added to indicate that individual 
shipments must be less than the TBq values specified in Category 2 of 
Appendix P to this part. In paragraph (a)(3), a sentence is added to 
require that individual shipments be less than the TBq values specified 
in Category 2 of Appendix P to this part. Paragraphs (a)(3) and (7) of 
the proposed rule are not being adopted. Proposed paragraph (a)(3) 
contained a drafting error which conflicts with the Nuclear Suppliers 
Group (NSG) Part 2 controls for certain alpha-emitting radionuclides. 
Proposed paragraph (a)(7) is no longer necessary because the sentences 
being added to paragraphs (a)(2) and (3) contain the relevant 
information.
    Section 110.27. Paragraph (a) is revised to include a reference to 
the new paragraph (f) in this section. A new paragraph (f) is inserted 
that requires that individual import shipments of radioactive material 
listed in the new Appendix P to part 110 and conducted under the 
general license provisions of Sec.  110.27(a) be below the amounts for 
Category 2.
    Section 110.32. In paragraph (f)(1), the curie value is replaced 
with TBq to make this paragraph consistent with the SI units used in 
Appendix P. A new paragraph (g) describing the documentation that must 
accompany an import application for radioactive material listed in the 
new Appendix P is added. Also, a new paragraph (h) describing the 
documentation that must accompany an export license application for 
radioactive material listed in the new Appendix P is added.
    Subpart D--Review of License Applications. Licensing criteria for 
radioactive material exports and imports, listed in Appendix P, are 
being added to this subpart.
    Section 110.40. In paragraph (b)(6)(iv), the curie value is 
replaced with TBq to make this paragraph consistent with the SI units 
used in Appendix P.
    Section 110.41. In paragraph (a)(3), the curie value is replaced 
with TBq to make this paragraph consistent with the SI units used in 
Appendix P.
    Section 110.42. New paragraph (e) is added to specify the licensing 
criteria for the export of Category 1 and 2 shipments of radioactive 
material listed in the new Appendix P.
    Section 110.43. New paragraphs (e) and (f) specify the licensing 
criteria for the import of radioactive material listed in the new 
Appendix P in amounts indicated for Categories 1 and 2.
    Section 110.45. A new paragraph (b)(5) describes the requirements 
for issuing import licenses for the radioactive material listed in the 
new Appendix P in amounts specified in Categories 1 and 2. Also, the 
final rule renumbers paragraphs (c) and (d) as paragraphs (d) and (e) 
and adds a new paragraph (c) that describes the appropriate steps that 
the U.S. Government will take to inform the exporting country that the 
recipient is authorized to receive and possess the source or sources to 
be exported.

Subpart E--License Terms and Related Provisions

    Section 110.50. In accordance with the proposed rule, existing 
paragraph (a)(3) had the word ``transport'' added after the word 
``use.'' Existing paragraphs (b)(4) and (b)(5) are redesignated as 
paragraphs (b)(5) and (b)(6) and a new paragraph (b)(4) is added to 
specify the advance notification requirements for the licensee 
exporting or importing material listed in Appendix P. Paragraph (b)(4) 
in the final rule differs from the proposed rule language in the 
following respects: (1) It is revised to indicate that a list of points 
of contact in the importing

[[Page 37990]]

countries will be made available on the NRC Office of International 
Programs external Web site http//:www.nrc.gov; (2) it is revised to 
indicate that the point of contact for receiving advance notifications 
for all export and import shipments is the NRC Operations Center and 
that relevant contact information will be provided on each export and 
import license; and (3) the requirement for advance notification of 
shipment within 10 days ``to the extent practical'' is changed to 
require notification within 7 days ``to the extent practical,'' to 
conform with the Guidance document. Paragraph (a)(3) is revised to make 
it clear that transport within the United States of radioactive 
material is not authorized by a general or specific export or import 
license issued under part 110. Redesignated paragraph (b)(5) is revised 
to clarify that part 110 licensees must comply with the NRC's domestic 
regulations covering transportation in 10 CFR part 71. Also, a new 
paragraph (b)(7) is added to indicate that advance notifications 
containing information on shipment dates for the quantities of the 
radionuclides in Appendix P should be controlled as sensitive, 
unclassified information.
    Appendix P to Part 110. The new Appendix P lists the radioactive 
material and the quantities requiring specific licenses. A new footnote 
added to Table 1 of Appendix P in the final rule states that the 
threshold values are specified in TBq, the regulatory standard 
consistent with the Code of Conduct. The curie value is given in 
parentheses only for information purposes and has been rounded after 
conversion from the TBq value. This change is necessary for two 
reasons. First, it will ensure the consistency of these regulations 
with the Code of Conduct and will facilitate advance shipment 
notifications to other competent government regulatory authorities 
which use the SI unit of TBq, not curies. Second, as was noted by a 
licensee during the Public Meeting of October 19, 2004, purchasers of 
sealed sources are, in some cases, already ordering the sources to be 
sized at just under the perceived Category 2 limit. For example, 
ordering a sealed source containing 19.75 curies of Am-241, just under 
the ``20 curie'' limit will result in a violation of the SI limit 
because a precise conversion of the 0.6 TBq Category 2 limit for Am-241 
equates to a 16.2 curie limit. Therefore, a lack of clarity in the 
regulatory standard would impede licensees' planning to coordinate 
their operational and investment plans with these regulations. In order 
to minimize the potential for conversion mistakes, the final rule 
differs from the proposed rule and the Code of Conduct in that the 
curie values in Appendix P have been rounded to two significant figures 
instead of one.
    In the final rule, Appendix P, Table 1, also includes Y-90, a decay 
product of the radionuclide, Sr-90, to maintain consistency with the 
Code of Conduct. A new footnote has been added to prescribe the 
methodology ``sum of the fractions'' for calculating effective 
quantities for combinations of radionuclides being transported 
together. The proposed rule did not contain any provisions on threshold 
limits for import and export shipments of multiple sealed sources or 
bulk material of the same radionuclide or multiple radionuclides. A 
``sum of fractions'' methodology, already used by the NRC in 10 CFR 
part 71, Appendix A, when evaluating the transportation limits of 
combination shipments of radionuclides, is included in Appendix P and 
is to be used for calculating shipments of bulk material and multiple 
sources and/or radionuclides.

Agreement State Compatibility

    Regulatory authority over the export and import of sources of 
concern is reserved to NRC under the AEA. Therefore, under the ``Policy 
Statement on Adequacy and Compatibility of Agreement State Programs,'' 
approved by the Commission on June 30, 1997, and published September 3, 
1997 (62 FR 46517), the rules being adopted are classified as 
compatibility Category ``NRC.'' Agreement States should not adopt 
equivalent rules.

Voluntary Consensus Standards

    The National Technology Transfer 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 the 
use of such a standard is inconsistent with applicable law or otherwise 
impractical. There are no voluntary consensus standards addressing this 
subject matter.

Environmental Impact: Categorical Exclusion

    The NRC has determined that this final rule is the 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 rule.

Paperwork Reduction Act Statement

    This final rule amends information collection requirements that are 
subject to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et 
seq.). These requirements were approved by the Office of Management and 
Budget (OMB), approval numbers 3150-0036 and 3150-0027.
    The burden to the public for these information collections is 
estimated to average 2.4 hours per application, 30 minutes per licensee 
advance notification to the NRC, and 15 minutes per recipient's 
certification to the licensee, including the time for reviewing 
instructions, searching existing data sources, gathering and 
maintaining the data needed, and completing and reviewing the 
information collection. Send comments on any aspect of these proposed 
information collections, including suggestions for reducing the burden, 
to the Records and FOIA/Privacy Services Branch (T-5 F52), U.S. Nuclear 
Regulatory Commission, Washington, DC 20555-0001, or by Internet 
electronic mail to [email protected]; and to the Desk Officer, 
Office of Information and Regulatory Affairs, NEOB-10202 (3150-0036 and 
3150-0027), Office of Management and Budget, Washington, DC 20503.

Public Protection Notification

    If a means used to impose an information collection does not 
display a currently valid OMB control number, the NRC may not conduct 
or sponsor, and a person is not required to respond to, the information 
collection.

Regulatory Analysis

    The Commission has prepared a regulatory analysis for this final 
rule. The analysis examines the cost and benefits of the alternatives 
considered by the Commission. The regulatory analysis is available in 
ADAMS (Accession No. ML051430150) and on the NRC's rulemaking Web site 
at http://ruleforum.llnl.gov. See also the discussion under Regulatory 
Flexibility Certification.

Regulatory Flexibility Certification

    This rule is necessary to reflect the nuclear and radioactive 
material security policies of the Executive Branch and to comply with 
international agreements and guidance to which the U.S. Government 
subscribes. On the basis of information available to the Commission, 
the final rule will not have a significant economic impact on a 
substantial number of small entities.

[[Page 37991]]

Backfit Analysis

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

Small Business Regulatory Enforcement Fairness Act

    In accordance with the Small Business Regulatory Enforcement 
Fairness 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, Exports, Imports, Intergovernmental relations, 
Nuclear materials, Nuclear power plants and reactors, Reporting and 
recordkeeping requirements, Scientific equipment.

0
For the reasons set out in the preamble and under the authority of the 
AEA; 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.

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

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

    Authority: Secs. 51, 53, 54, 57, 63, 64, 65, 81, 82, 103, 104, 
109, 111, 126, 127, 128, 129, 161, 181, 182, 183, 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, 2201, 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 110.130-110.135 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 ``exceptional circumstances'' is 
added, and the definition of ``specific activity'' is revised to read 
as follows:


Sec.  110.2  Definitions.

* * * * *
    Exceptional circumstances means, with respect to exports from the 
United States of radioactive material listed in Table 1 of Appendix P 
of this part:
    (1) Cases of considerable health or medical need as acknowledged by 
the U.S. Government and the government of the importing country;
    (2) Cases where there is an imminent radiological hazard or 
security threat presented by one or more radioactive sources; and
    (3) Cases in which the exporting facility or U.S. Government 
maintains control of the radioactive material throughout the period the 
material is outside of the U.S. and removes the material at the 
conclusion of this period.
* * * * *
    Specific activity means the radioactivity of a radionuclide per 
unit mass of that nuclide, expressed in the SI unit of Terabequerels 
per gram (TBq/g). Values of specific activity are found in Appendix A 
to part 71 of this chapter.
* * * * *


Sec.  110.21  [Amended]

0
3. In Sec.  110.21, paragraph (a)(4) is amended by removing ``100 
millicuries'' and adding in its place ``3.7 x 10-\5\ TBq 
(100 millicuries).''


Sec.  110.22  [Amended]

0
4. In Sec.  110.22, paragraph (a)(3) is amended by removing ``100 
millicuries'' and adding in its place ``3.7 x 10-\5\ TBq 
(100 millicuries).''

0
5. In Sec.  110.23, paragraphs (a)(2), (a)(3), (a)(5), and (a)(6) are 
revised as follows:


Sec.  110.23  General license for the export of byproduct material.

    (a) * * *
    (2) Actinium-225 and -227, americium-241 and -242m, californium-
248, -249, -250, -251, -252, -253, and -254, curium-240, -241, -242, -
243, -244, -245, -246 and -247, einsteinium-252, -253, -254 and -255, 
fermium-257, gadolinium-148, mendelevium-258, neptunium-235 and -237, 
polonium-210, and radium-223 must be contained in a device, or a source 
for use in a device, in quantities of less than 3.7 x 10-5 
TBq (100 millicuries) of alpha activity per device or source, unless 
the export is to a country listed in Sec. 110.30. Individual shipments 
must be less than the TBq values specified in Category 2 of Table 1 of 
Appendix P to this part. Exports of americium and neptunium are subject 
to the reporting requirements listed in paragraph (b) of this section.
    (3) For americium-241, exports must not exceed 0.6 TBq (16 curies) 
per device or 60 TBq (1,600 curies) to any one country listed in Sec.  
110.29, and must be contained in industrial process control equipment 
or petroleum exploration equipment in quantities of less than 0.6 TBq 
(16 curies) per device and per shipment, not to exceed 60 TBq (1,600 
curies) per year to any one country. Individual shipments to all 
countries other than those listed in Sec. Sec.  110.28 and 110.29 must 
be less than 0.6 TBq (16 curies) per shipment, consistent with Appendix 
P to this part.
* * * * *
    (5) For polonium-210, the material must be contained in static 
eliminators and may not exceed 3.7 TBq (100 curies) per individual 
shipment.
    (6) For tritium in any dispersed form, except for recovery or 
recycle purposes (e.g., luminescent light sources and paint, 
accelerator targets, calibration standards, labeled compounds), exports 
must not exceed the quantity of 0.37 TBq (10 curies (1.03 milligrams)) 
or less per item, not to exceed 37 TBq (1,000 curies (103 milligrams)) 
per shipment or 370 TBq (10,000 curies (1.03 grams)) per year to any 
one country. Exports of tritium to the countries listed in Sec.  110.30 
must not exceed the quantity of 1.48 TBq (40 curies (4.12 milligrams)) 
or less per item, not to exceed 37 TBq (1,000 curies (103 milligrams)) 
per shipment or 370 TBq (10,000 curies (1.03 grams)) per year to any, 
one country, and exports of tritium in luminescent safety devices 
installed in aircraft must not exceed a quantity of 1.48 TBq (40 curies 
(4.12 milligrams)) or less per light source.
* * * * *

0
6. In Sec.  110.27, the introductory text of the paragraph (a) is 
revised and a new paragraph (f) is added as follows:


Sec.  110.27  General license for import.

    (a) Except as provided in paragraphs (b), (c), and (f) of this 
section, a general license is issued to any person to import byproduct, 
source, or special nuclear material if the consignee is authorized to 
receive and possess the material under:
* * * * *
    (f) Individual import shipments of radioactive material listed in 
Appendix P must be less than the amounts specified in Category 2 in 
Table 1 of Appendix P to this part.

0
7. In Sec.  110.32, paragraph (f)(1) is revised and new paragraphs (g) 
and (h) are added to read as follows:

[[Page 37992]]

Sec.  110.32  Information required in an application for a specific 
license/NRC Form 7.

* * * * *
    (f) * * *
    (1) Maximum quantity of material in grams or kilograms 
(terabequerels or TBq for byproduct material) and its chemical and 
physical form.
* * * * *
    (g) For proposed imports of material listed in Table 1 of Appendix 
P to this part, a copy of the applicant's authorization to receive and 
possess the radioactive material to be imported for each recipient.
    (h) For proposed exports of material listed in Table 1 of Appendix 
P to this part, pertinent documentation that the recipient of the 
material has the necessary authorization under the laws and regulations 
of the importing country to receive and possess the material. Pertinent 
documentation shall consist of a copy of the recipient's authorization 
to receive and possess the material to be exported or a confirmation 
from the government of the importing country that the recipient is so 
authorized. The recipient authorization shall include the following 
information:
    (1) Name of the recipient
    (2) Recipient location and legal address or principal place of 
business
    (3) Relevant radionuclides and radioactivity being imported or that 
the recipient is authorized to receive and possess
    (4) Uses, if appropriate
    (5) The expiration date of the recipient's authorization (if any)


Sec.  110.40  [Amended]

0
8. In Sec.  110.40, paragraph (b)(6)(iv) is amended by removing ``1,000 
curies of tritium'' and adding in its place ``37 TBq (1,000 curies) of 
tritium.''


Sec.  110.41  [Amended]

0
9. In Sec.  110.41, paragraph (a)(3) is amended by removing ``100 
curies of tritium'' and adding in its place ``3.7 TBq (100 curies) of 
tritium.''
0
10. In Sec.  110.42, new paragraph (e) is added to read as follows:


Sec.  110.42  Export licensing criteria.

* * * * *
    (e) In making its findings under paragraphs (a)(8) and (c) of this 
section for proposed exports of radioactive material listed in Appendix 
P to this part, the NRC shall consider:
    (1) Whether the foreign recipient is authorized based on the 
authorization or confirmation required by Sec.  110.32(g) to receive 
and possess the material under the laws and regulations of the 
importing country;
    (2) Whether the importing country has the appropriate technical and 
administrative capability, resources and regulatory structure to manage 
the material in a safe and secure manner;
    (3) For proposed exports of Category 1 amounts of radioactive 
material listed in Table 1 of Appendix P to this part, whether the 
government of the importing country provides consent to the United 
States Government for the import of the material;
    (4) In cases where the importing country does not have the 
technical and administrative capability described in paragraph (e)(2) 
of this section, and in cases where there is insufficient evidence of 
the recipient's authorization to receive and possess the material to be 
exported, described in paragraph (e)(1) of this section, whether 
exceptional circumstances exist, and if so, whether the export should 
be licensed in light of those exceptional circumstances and the risks, 
if any, to the common defense and security of the proposed export;
    (5) For proposed exports under exceptional circumstances of 
Category 1 or Category 2 amounts of radioactive material listed in 
Table 1 of Appendix P to this part, whether the government of the 
importing country provides consent to the United States Government for 
the import of the material;
    (6) For proposed exports of radioactive material listed in Table 1 
of Appendix P to this part under the exceptional circumstance in which 
there is a considerable health or medical need as acknowledged by the 
U.S. Government and the importing country, whether the United States 
and the importing country have, to the extent practicable, made 
arrangements for the safe and secure management of the radioactive 
sources during and at the end of their useful life;
    (7) Based upon the available information, whether the foreign 
recipient has engaged in clandestine or illegal procurement of 
radioactive material listed in Table 1 of Appendix P to the part;
    (8) Based upon available information, whether an import or export 
authorization for radioactive material listed in Table 1 of Appendix P 
to this part has been denied to the recipient or importing country, or 
whether the recipient or importing country has diverted any import or 
export of radioactive material previously authorized; and
    (9) Based upon available information, whether there is a risk of 
diversion or malicious acts involving radioactive material in Table 1 
of Appendix P to this part.

0
11. In Sec.  110.43, new paragraphs (e) and (f) are added to read as 
follows:


Sec.  110.43  Import licensing criteria.

* * * * *
    (e) With respect to proposed imports of radioactive material listed 
in Appendix P to this part, the NRC shall consider whether the U.S. 
recipient is authorized to possess the material under a contract with 
the Department of Energy or a license issued by the Commission or a 
State with which the Commission has entered into an agreement under 
Section 274b of the AEA.
    (f) In making its findings under paragraphs (a) and (b) of this 
section for proposed imports of radioactive material listed in Appendix 
P to this part, the NRC shall consider:
    (1) Based upon available information, whether the applicant has 
been engaged in clandestine or illegal procurement of radioactive 
material listed in Table 1 of Appendix P to this part;
    (2) Based upon available information, whether an import or export 
authorization for radioactive material has been denied to the applicant 
or whether the applicant has diverted any import or export of 
radioactive material previously authorized; and
    (3) Based upon available information, whether a risk of diversion 
or malicious acts involving the radioactive material listed in Table 1 
of Appendix P to this part.

0
12. In Sec.  110.45, paragraphs (c) and (d) are redesignated as 
paragraphs (d) and (e), respectively, and new paragraphs (b)(5) and (c) 
are added as follows:


Sec.  110.45  Issuance or denial of license.

* * * * *
    (b) * * *
    (5) With respect to a proposed import of radioactive material 
listed in Table 1 of Appendix P to this part, the U.S. recipient is 
authorized to receive and possess the material under a contract with 
the Department of Energy or a license issued by the Commission or a 
State with which the Commission has entered into an agreement under 
Section 274b. of the Atomic Energy Act.
    (c) With respect to a proposed import of radioactive material 
listed in Table 1 of Appendix P to this part:
    (1) If the Commission authorizes a proposed import of Category 1 or 
Category 2 amounts of radioactive material, it will take appropriate 
steps to ensure that a copy of the recipient authorization, or 
confirmation by the U.S. Government that the recipient is authorized to 
receive and possess the source or sources to be exported, is provided 
to the Government of the

[[Page 37993]]

exporting country or to the exporting facility.
    (2) If the Commission authorizes a proposed import of Category 1 
amounts of radioactive material, it will take appropriate steps to 
ensure that a copy of the consent of the United States Government to 
the import is provided to the government of the exporting country in 
cases where it is requested by such government.
* * * * *

0
13. Section 110.50, is amended as follows:
0
a. In paragraph (a)(3), add the word ``transport'' after the word 
``use,''
0
b. Paragraphs (b)(4) and (b)(5) are redesignated as paragraphs (b)(5) 
and (b)(6),
0
c. Add the number ``71'' after the number ``70'' in the newly 
redesignated paragraph (b)(5), and
0
d. Add new paragraphs (b)(4) and (b)(7) to read as follows:


Sec.  110.50  Terms.

* * * * *
    (b) * * *
    (4) A licensee authorized to export or import the radioactive 
material listed in Appendix P to this part is responsible for notifying 
NRC and, in cases of exports, the government of the importing country 
in advance of each shipment. A list of points of contact in importing 
countries is available at NRC's Office of International Programs 
website, accessible on the NRC Public Web Site by the following links 
to What We Do--International Programs. The NRC's office responsible for 
receiving advance notifications for all export and import shipments is 
the NRC Operations Center. Specific details on where to send the 
information will be listed in each specific export and import license. 
Notifications must be received by the NRC at least 7 days in advance of 
each shipment, to the extent practical, but in no case less than 24 
hours in advance of each shipment. Notifications may be electronic or 
in writing on business stationary, and must contain or be accompanied 
by the information which follows.
    (i) For export notifications:
    (A) Part 110 export license number and expiration date;
    (B) Name of the individual and licensee making the notification, 
address, and telephone number;
    (C) Foreign recipient name, address, and end use location(s) (if 
different than recipient's address);
    (D) Radionuclides and activity level in TBq, both for single and 
aggregate shipments;
    (E) Make, model and serial number, for any Category 1 and 2 sealed 
sources, if available;
    (F) End use in the importing country, if known;
    (G) Shipment date;
    (H) A copy of the foreign recipient's authorization or confirmation 
of that authorization from the government of the importing country as 
required by Sec.  110.32(h).
    (ii) For import notifications:
    (A) Part 110 import license number and expiration date;
    (B) Name of individual and licensee making the notification, 
address, and telephone number;
    (C) Recipient name, location, and address (if different than 
above);
    (D) Radionuclides and activity level in TBq, both for single and 
aggregate shipments;
    (E) Make, model and serial number, radionuclide, and activity level 
for any Category 1 and 2 sealed sources, if available;
    (F) End use in the U.S.;
    (G) Shipment date from exporting facility and estimated arrival 
date at the end use location;
    (H) NRC or Agreement State license number to possess the import in 
the U.S. and expiration date.
* * * * *
    (7) Advance notifications containing the above information must be 
controlled, handled, and transmitted in accordance with Sec.  2.390 of 
this chapter and other applicable NRC requirements governing protection 
of sensitive information.

0
14. A new Appendix P to part 110 is added to read as follows:

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

                                  Table 1.--Import and Export Threshold Limits
----------------------------------------------------------------------------------------------------------------
                                                      Category 1                          Category 2
                                         -----------------------------------------------------------------------
          Radioactive material              Terabequerels                       Terabequerels
                                                (TBq)       Curies  (Ci) \1\        (TBq)       Curies  (Ci) \1\
----------------------------------------------------------------------------------------------------------------
Americium-241...........................                60             1,600               0.6                16
Americium-241/Be........................                60             1,600               0.6                16
Californium-252.........................                20               540               0.2               5.4
Curium-244..............................                50             1,400               0.5                14
Cobalt-60...............................                30               810               0.3               8.1
Cesium-137..............................               100             2,700               1.0                27
Gadolinium-153..........................             1,000            27,000              10.0               270
Iridium-192.............................                80             2,200               0.8                22
Plutonium-238\2\........................                60             1,600               0.6                16
Plutonium-239/Be \2\....................                60             1,600               0.6                16
Promethium-147..........................            40,000         1,100,000               400            11,000
Selenium-75.............................               200             5,400               2.0                54
Strontium-90 (Y-90).....................             1,000            27,000              10.0               270
Thulium-170.............................            20,000           540,000               200             5,400
Ytterbium-169...........................               300             8,100               3.0               81
----------------------------------------------------------------------------------------------------------------
\1\ The values to be used to determine whether a license is required are given in TBq. Curie (Ci) values are
  provided for practical usefulness only and are rounded after conversion.
\2\ The limits for Pu-238 and Pu-239/Be in this table apply for imports to the U.S. The limits for exports of Pu-
  238 and Pu-239/Be can be found in Sec.   110.21.

Calculation of Shipments Containing Multiple Sources or 
Radionuclides

    The ``sum of fractions'' methodology for evaluating combinations 
of radionuclides being transported, is to be used when import or 
export shipments contain multiple sources or multiple radionuclides. 
The threshold limit values used in a sum of the fractions 
calculation must be the metric values (i.e., TBq).
    I. If multiple sources and/or multiple radionuclides are present 
in an import or export shipment, the sum of the fractions of

[[Page 37994]]

the activity of each radionuclides must be determined to verify the 
shipment is less than the Category 1 or 2 limits of Table 1, as 
appropriate. If the calculated sum of the fractions ratio, using the 
following equation, is greater than or equal to 1.0, then the import 
or export shipment exceeds the threshold limits of Table 1 and the 
applicable security provisions of this part apply.
    II. Use the equation below to calculate the sum of the fractions 
ratio by inserting the actual activity of the applicable 
radionuclides or of the individual sources (of the same 
radionuclides) in the numerator of the equation and the 
corresponding threshold activity limit from the Table 1 in the 
denominator of the equation. Ensure the numerator and denominator 
values are in the same units and all calculations must be performed 
using the TBq (i.e., metric) values of Table 1.

R1 = activity for radionuclides or source number 1
R2 = activity for radionuclides or source number 2
RN = activity for radionuclides or source number n
AR1 = activity limit for radionuclides or source number 1
AR2 = activity limit for radionuclides or source number 2
ARN = activity limit for radionuclides or source number n

[GRAPHIC] [TIFF OMITTED] TR01JY05.055


    Dated in Rockville, Maryland, this 27th day of June, 2005.

    For the Nuclear Regulatory Commission.
Annette L. Vietti-Cook,
Secretary of the Commission.
[FR Doc. 05-12985 Filed 6-30-05; 8:45 am]
BILLING CODE 7590-01-P