[Federal Register Volume 77, Number 204 (Monday, October 22, 2012)]
[Proposed Rules]
[Pages 64435-64437]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-25924]


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Proposed Rules
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains notices to the public of 
the proposed issuance of rules and regulations. The purpose of these 
notices is to give interested persons an opportunity to participate in 
the rule making prior to the adoption of the final rules.

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Federal Register / Vol. 77, No. 204 / Monday, October 22, 2012 / 
Proposed Rules

[[Page 64435]]



NUCLEAR REGULATORY COMMISSION

10 CFR Part 110

[NRC-2012-0008]


Branch Technical Position on the Import of Non-U.S. Origin 
Radioactive Sources

AGENCY: Nuclear Regulatory Commission.

ACTION: Request for comment.

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SUMMARY: In 2010, the NRC published a final rule amending its 
regulations concerning export and import of nuclear equipment and 
material. Among other things, it added the phrase ``Of U.S. origin'' to 
the first exclusion to the definition of ``radioactive waste''. The 
phrase was added to the final rule in response to a public comment on 
the proposed rule to clarify the exclusion. Since publication of the 
final rule, NRC staff has been engaged with industry in response to 
concerns raised regarding established industry practices and the need 
for guidance on implementation of the ``U.S.-origin'' exclusion.

DATES: Members of the public may submit written comments on the issues 
discussed in this notice. Comments on the issues presented in this 
notice should be postmarked no later than December 21, 2012. Comments 
received after this date will be considered if it is practical to do 
so. NRC plans to consider these stakeholder views in the development of 
a final Branch Technical Position (BTP).
    The proposed BTP is included in the SUPPLEMENTARY INFORMATION 
section of this document and is also available in NRC's Agencywide 
Documents Access and Management System (ADAMS) under ML12278A170.

ADDRESSES: You may access information and comment submissions related 
to this document, which the NRC possesses and are publicly available, 
by searching on http://www.regulations.gov under Docket ID NRC-2012-
0008. You may submit comments by any of the following methods (unless 
this document describes a different method for submitting comments on a 
specific subject):
     Federal rulemaking Web site: Go to http://www.regulations.gov and search for Docket ID NRC-2012-0008. Address 
questions about NRC dockets to Carol Gallagher; telephone: 301-492-
3668; email: Carol.Gallagher@nrc.gov.
     Mail comments to: Secretary, U.S. Nuclear Regulatory 
Commission, Washington, DC 20555-0001, ATTN: Rulemaking and 
Adjudications Staff.
     Email comments to: Rulemaking.Comments@nrc.gov. If you do 
not receive a reply email confirming that we have received your 
comments, contact us directly at 301-415-1677.
     Hand deliver comments to: 11555 Rockville Pike, Rockville, 
Maryland 20852.
     Fax comments to: Secretary, U.S. Nuclear Regulatory 
Commission at 301-415-1101.
    For additional direction on accessing information and submitting 
comments, see ``Accessing Information and Submitting Comments'' in the 
SUPPLEMENTARY INFORMATION section of this document.

FOR FURTHER INFORMATION CONTACT: Jennifer Tobin Wollenweber, Office of 
International Programs, U.S. Nuclear Regulatory Commission, Washington, 
DC 20555-0001; telephone: 301-415-2328; email: Jennifer.Tobin@nrc.gov.

SUPPLEMENTARY INFORMATION:

I. Accessing Information and Submitting Comments

A. Accessing Information

    Please refer to Docket ID NRC-2012-0008 when contacting the NRC 
about the availability of information regarding this document. You may 
access information related to this document, which the NRC possesses 
and are publicly available, by any of the following methods:
     Federal Rulemaking Web Site: Go to http://www.regulations.gov and search for Docket ID NRC-2012-0008.
     NRC's Agencywide Documents Access and Management System 
(ADAMS): You may access publicly available documents online in the NRC 
Library at http://www.nrc.gov/reading-rm/adams.html. To begin the 
search, select ``ADAMS Public Documents'' and then select ``Begin Web-
based ADAMS Search.'' For problems with ADAMS, please contact the NRC's 
Public Document Room (PDR) reference staff at 1-800-397-4209, 301-415-
4737, or by email to pdr.resource@nrc.gov. The ADAMS accession number 
for each document referenced in this document (if that document is 
available in ADAMS) is provided the first time that a document is 
referenced.
     NRC's PDR: You may examine and purchase copies of public 
documents at the NRC's PDR, Room O1-F21, One White Flint North, 11555 
Rockville Pike, Rockville, Maryland 20852.

B. Submitting Comments

    Please include Docket ID NRC-2012-0008 in the subject line of your 
comment submission, in order to ensure that the NRC is able to make 
your comment submission available to the public in this docket.
    The NRC cautions you not to include identifying or contact 
information that you do not want to be publicly disclosed in your 
comment submission. The NRC will post all comment submissions at http://www.regulations.gov as well as enter the comment submissions into 
ADAMS. The NRC does not routinely edit comment submissions to remove 
identifying or contact information.
    If you are requesting or aggregating comments from other persons 
for submission to the NRC, then you should inform those persons not to 
include identifying or contact information that they do not want to be 
publicly disclosed in their comment submission. Your request should 
state that the NRC does not routinely edit comment submissions to 
remove such information before making the comment submissions available 
to the public or entering the comment submissions into ADAMS.

II. Background

    As a result of the Federal Register Notice (77 FR 2924) ``Notice of 
Public Meeting and Request for Comment on the Branch Technical Position 
on the Import of Non-U.S. Origin Radioactive Sources,'' published 
January 20, 2012, five comment letters were received for consideration 
by the NRC. At that time, the BTP was a working draft document with the 
intent of using feedback to enhance the document for publication of the 
revised proposed BTP for formal public comment. Of the comments made on 
the original draft BTP, most were

[[Page 64436]]

comments on the existing rule rather than in the guidance that the BTP 
provides. The NRC response to these informal comments can be found at 
ML1255A106. Most of the comments did not oppose the underlying policy 
rationale and justification for the BTP's proposal to construe ``non-
U.S. origin'' disused sources as ``U.S. origin'' for the purpose of the 
first exclusion to the definition of ``radioactive waste'' under 
certain circumstances; instead, the comments appear to request NRC to 
revise or clarify the existing exclusions. Therefore, NRC did not 
consider these comments to be within the scope of the BTP. As a result 
of these comments, there are no substantive changes to the draft BTP. 
However, minor editorial changes were made to the draft BTP to provide 
greater clarity. This proposed BTP does not change the regulations in 
10 CFR part 110; it clarifies what is meant by ``U.S. origin'' and 
details how the NRC interprets this exclusion to the definition of 
``radioactive waste.''

III Branch Technical Position

A. Introduction

    The NRC's regulations in 10 CFR part 110 (Part 110), ``Export and 
Import of Nuclear Equipment and Material,'' establishes the general and 
specific export and import licensing requirements for special nuclear, 
source, and byproduct material including radioactive waste. 
``Radioactive waste'' is defined in 10 CFR 110.2 as ``[a]ny material 
that contains or is contaminated with source, byproduct or special 
nuclear material that by its possession would require a specific 
radioactive material license in accordance with this Chapter [10 CFR 
Chapter I] and is imported or exported for the purposes of disposal in 
a land disposal facility as defined in 10 CFR Part 61, a disposal area 
as defined in Appendix A of 10 CFR Part 40, or an equivalent 
facility.''
    There are six exclusions in 10 CFR 110.2 to the definition of 
``radioactive waste.'' The sealed source exclusion (exclusion one) is 
defined as radioactive material that is ``[o]f U.S. origin and 
contained in a sealed source, or device containing a sealed source, 
that is being returned to a manufacturer, distributor or other entity 
which is authorized to receive and possess the sealed source or the 
device containing a sealed source.'' \1\ Disused sources that satisfy 
an exclusion to the definition of ``radioactive waste'' may be imported 
under the general license in 10 CFR 110.27, which requires that the 
U.S. consignee be authorized to receive and possess the material under 
the relevant NRC or Agreement State regulations and that the importer 
satisfy the terms for the general license set forth in 10 CFR 110.50.
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    \1\ The NRC provided the following guidance on the scope of 
``U.S. origin'' on NRC's Export and Import Web page at (http://www.nrc.gov/about-nrc/ip/export-import.html):
    ``U.S. origin was added in the first exclusion to the definition 
of radioactive waste to clarify that the exclusion only applies to 
sources of U.S. origin. U.S. origin sources may include sources with 
U.S. origin material and sources or devices manufactured, assembled 
or distributed by a U.S. company from a licensed domestic facility. 
Disused sources that originated in a country other than the United 
States would require a specific license if being exported or 
imported for disposal.''
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    The NRC has developed this technical position to provide guidance 
to source manufacturers, distributors, or other entity on the NRC's 
application of the sealed source exclusion to imports into the U.S. of 
non-U.S. origin disused sources.\2\
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    \2\ The terms ``supplier'' and ``importer'' are used 
interchangeably in this document with ``manufacturers, distributors, 
or other entity.''
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B. Background

    On July 28, 2010, the NRC published a final rule in the Federal 
Register (75 FR 44072) that amended several provisions in 10 CFR part 
110 to improve NRC's regulatory framework for the export and import of 
nuclear equipment, material, and radioactive waste. The sealed source 
exclusion to the definition of ``radioactive waste'' was revised, in 
response to a comment, to confirm that the exclusion only applies to 
sources of ``U.S. origin'' being returned to an authorized domestic 
licensee. The addition of the term ``U.S. origin'' to the sealed source 
exclusion was consistent with the original intent of the exclusion, 
initially adopted in a 1995 rule.\3\ In accordance with International 
Atomic Energy Agency (IAEA) Code of Conduct on the Safety and Security 
of Radioactive Sources and the IAEA supplemental Guidance on the Import 
and Export of Radioactive Sources, the NRC believed that encouraging 
return of disused sources to the country of origin would help prevent 
sources from becoming ``orphaned'' by facilitating responsible handling 
of sources at the end of their life cycle. See Import and Export of 
Radioactive Waste, 57 FR 17859, 17861 (July 21, 1992) (proposed rule) 
(``the return of used or depleted sealed sources, gauges, and similar 
items to the U.S. or to another original exporting country for 
reconditioning, recycling or disposal may * * * help ensure that such 
materials are handled responsibly and not left in dispersed and perhaps 
unregulated locations around the world''). The NRC's willingness to 
embrace this policy was in large part informed by U.S. industry 
comments that there is a ``widely accepted practice, usually rooted in 
a sales or leasing contract or other agreement, of returning depleted 
sealed radioactive sources, used gauges, and other instruments 
containing radioactive materials * * * to the original supplier-
manufacturer for recycle or disposal.'' 57 FR 17864. See also, e.g., 
id. at 17861 (``the sale of a source is often conditioned on later 
return of the source for disposal''). Accordingly, central to the 
sealed source exclusion was the NRC's understanding, based on U.S. 
industry representations, that new and disused sources are routinely 
exchanged on a ``one-for-one'' basis--i.e., a new source is exchanged 
for a disused source \4\--with the result that the number of disused 
sources imported is not greater than the number of new sources 
exported.
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    \3\ Import and Export of Radioactive Waste, 60 FR 37556 (July 
21, 1995).
    \4\ The sealed sources are changed out when the decay of the 
source limits the usefulness of the material. At this point, a 
supplier typically will send a new source and the user will return 
the used source in the same shielded container. This practice is 
typically formalized in the contract between the user and the 
supplier. Sometimes the sources are still useful and can be recycled 
for re-use in a different application. In that case, the sixth 
exclusion to the definition of ``radioactive waste'' applies and the 
source can be imported under a general license even if it is non-
U.S. origin. Guidance on this exclusion can be found on NRC's Export 
and Import Web page at http://www.nrc.gov/about-nrc/ip/export-import.html and is in harmony with this position paper.
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    After the addition of ``U.S. origin'' to the sealed source 
exclusion in the 2010 rule, it came to the staff's attention that, 
while it remains a widespread industry practice to exchange new and 
disused sources on a ``one-for-one'' basis, in light of the current 
global supply market it is not always possible for a supplier to 
definitively ascertain the origin of a particular disused source that 
is exchanged for a new one before import and receipt of the disused 
source. With established customers, the disused sources will generally 
be of U.S. origin; however, for new customers, some of the sources 
initially being returned may not be of U.S. origin.
    Once a source is imported and received, the manufacturer, 
distributor, or other entity technically has the ability to determine 
the source's origin. However, the only way for the supplier to 
accomplish this is by exposing its personnel to additional radiation 
doses. Specifically, the supplier must use a glove-box to take the 
source out of its casing to read the serial numbers and

[[Page 64437]]

correlate those numbers to different manufacturer's coding patterns.

C. Regulatory Position

    The NRC has construed the ``U.S. origin'' provision in the context 
of the industry's recent clarification of international source exchange 
practices. The NRC recognizes that in some circumstances it may not be 
feasible for the importer to determine the country of origin for 
disused sources it seeks to exchange prior to import. If, after a good 
faith effort, the U.S. manufacturer, distributor, or other entity 
cannot determine whether an imported disused source that has been 
exchanged for a new source is of U.S. origin without exposing personnel 
to additional doses, the source in question shall be deemed to be of 
U.S. origin for the purposes of the sealed source exclusion to the 
definition of ``radioactive waste'' in 10 CFR 110.2.\5\ This 
application of the sealed source exclusion is limited to disused 
sources imported into the United States that have been exchanged for a 
new source in a foreign country on a ``one-for-one'' basis. 
Accordingly, it is the NRC's expectation that the number of disused 
sources imported by the manufacturer or distributor into the United 
States must not be greater than the number of new or refurbished 
sources exported by that manufacturer or distributor.
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    \5\ The definition of ``radioactive waste'' in this Branch 
Technical Position paper pertains solely to export and import. It 
does not affect or alter the domestic regulations of ``waste'' as 
defined in 10 CFR 20.1003.
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    The NRC believes that this application of the sealed source 
exclusion reasonably balances the interests of public health and safety 
and international policy interests in responsible handling of sources 
at the end of their useful life. The approach preserves the fundamental 
policy rationale underlying the original exclusion--to prevent sources 
from being dispersed in unregulated locations around the world by 
facilitating a ``one-for one'' exchange of U.S.-supplied new and 
disused sources--while achieving occupational doses to workers that are 
as low as reasonably achievable, as specified in 10 CFR 20.1101(b).
    The NRC expects U.S. manufacturers, distributors, and suppliers to 
inform their customers about U.S. import licensing requirements for 
disused sources. It is recommended that U.S. importers retain copies of 
their communications with their foreign customers regarding U.S. import 
requirements. The U.S. importer at all times must comply with the 
specific license requirement for disused sources known to be of non-
U.S. origin prior to import into the United States. A good faith effort 
by the importer may include communication of U.S. import requirements 
with its foreign customers, examination of a photograph of the source 
the customer seeks to exchange, and other relevant information related 
to the disused sources' origin.
    Consistent with 10 CFR 110.53, the NRC may inspect the licensee's 
records, premises and activities pertaining to its exports and imports 
to ensure compliance with the sealed source exclusion to the definition 
of ``radioactive waste'' by trying to determine source origin (from 
user paperwork and communication) before an import occurs.
    This position is being distributed to all Agreement States and 
material licensees.
    Additionally, the NRC has coordinated this position with the 
Department of Energy/National Nuclear Safety Administration's (DOE/
NNSA) Global Threat Reduction Initiative (GTRI). One of GTRI's programs 
repatriates sources from around the world that are in unsafe or 
insecure locations. The NRC does not have import licensing jurisdiction 
when U.S. companies import disused sources on behalf of NNSA's GTRI 
program; therefore, the licensing requirements in Part 110 would not 
apply to such imports.

D. Implementation

    This technical position reflects the current NRC staff position on 
acceptable use of the general license for import of disused radioactive 
sources. Therefore, except in those cases in which the source 
manufacturer or distributor proposes an acceptable alternative method 
for complying with the definition of ``radioactive waste'' in Section 
110.2, the guidance described herein will be used in the evaluation of 
the use of the general import license for disused sources.

    Dated at Rockville, Maryland, this 15th day of October 2012.

    For the Nuclear Regulatory Commission.
Margaret M. Doane,
Director, Office of International Programs.
[FR Doc. 2012-25924 Filed 10-19-12; 8:45 am]
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