[Federal Register Volume 77, Number 204 (Monday, October 22, 2012)]
[Proposed Rules]
[Pages 64435-64437]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-25924]
========================================================================
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.
========================================================================
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.
-----------------------------------------------------------------------
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: [email protected].
Mail comments to: Secretary, U.S. Nuclear Regulatory
Commission, Washington, DC 20555-0001, ATTN: Rulemaking and
Adjudications Staff.
Email comments to: [email protected]. 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: [email protected].
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 [email protected]. 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.
---------------------------------------------------------------------------
\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.''
---------------------------------------------------------------------------
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\
---------------------------------------------------------------------------
\2\ The terms ``supplier'' and ``importer'' are used
interchangeably in this document with ``manufacturers, distributors,
or other entity.''
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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]
BILLING CODE 7590-01-P