[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]
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Rules and Regulations
Federal Register
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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.
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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.
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\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.
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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