[Federal Register Volume 77, Number 13 (Friday, January 20, 2012)]
[Proposed Rules]
[Pages 2924-2926]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-1209]

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. 13 / Friday, January 20, 2012 / 
Proposed Rules

[[Page 2924]]


10 CFR Part 110


Notice of Public Meeting and Request for Comment on the Branch 
Technical Position on the Import of Non-U.S. Origin Radioactive Sources

AGENCY: Nuclear Regulatory Commission.

ACTION: Notice of public meeting and request for comment.


SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) plans to conduct 
a public meeting on January 24, 2012, in Rockville, Maryland, to 
solicit input on a draft Branch Technical Position (BTP) on the Import 
of non-U.S. Origin Radioactive Sources. In 2010, the NRC published a 
final rule amending 10 CFR part 110 (75 FR 44072; July 28, 2010). Among 
other things, it added the phrase ``Of U.S. origin'' to the first 
exclusion to the definition of ``radioactive waste'' in Sec.  110.2. 
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, industry has raised concerns with NRC staff regarding 
established industry practices and the need for guidance on 
implementation of the ``U.S. origin'' exclusion. The staff is holding a 
public meeting to obtain comments from stakeholders on the draft BTP 
and to discuss implementation issues associated with the ``U.S. 
origin'' exclusion.

DATES: Members of the public may provide feedback at the public meeting 
or may submit written comments on the issues discussed in this 
document. Comments on the BTP presented in this notice and discussed at 
the meeting should be postmarked no later than March 5, 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 revised draft BTP.
    Written comments may be sent to the address listed in the ADDRESSES 
section. Questions about participation in the public meeting should be 
directed to the facilitator at the address listed in the ADDRESSES 
section. Replies should be directed to the points of contact listed in 
    The public meeting will be held on January 24, 2012, from 9:00 to 
11 a.m. at One White Flint North, Room 16-B04, 11555 Rockville Pike, 
Rockville, Maryland 20852.
    The agenda for the public meeting will be noticed no fewer than ten 
(10) days prior to the meeting on the NRC's electronic public meeting 
schedule web page at http://www.nrc.gov/public-involve/public-meetings/index.cfm. Please refer to the SUPPLEMENTARY INFORMATION section of 
this notice for questions that will be discussed at the meeting. The 
supplemental information below also contains a copy of the draft BTP. 
The draft BTP is available in the Agencywide Documents Access and 
Management System (ADAMS) under ML11300A194.
    The staff has prepared the BTP draft for review by stakeholders. 
This draft is meant to serve as a starting point for NRC's efforts to 
develop the document. This draft 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.''
    Staff is using the public's input, now, to frame and develop the 
scope of the draft BTP, which will be issued again. Following the 
public meeting, staff will consider comments received at the meeting 
and in response to this Federal Register notice, and then formally 
issue a BTP for comment in the Federal Register.

ADDRESSES: Please include Docket ID NRC-2012-0008 in the subject line 
of your comments. For additional instructions on submitting comments 
and instructions on accessing documents related to this action, see 
``Submitting Comments and Accessing Information'' in the SUPPLEMENTARY 
INFORMATION section of this document. You may submit comments by any 
one of the following methods:
     Federal Rulemaking Web site: Go to http://www.regulations.gov and search 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: Rulemakings 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 FURTHER INFORMATION CONTACT: Jenny Tobin Wollenweber, Office of 
International Programs, U.S. Nuclear Regulatory Commission, Washington, 
DC 20555-0001; telephone (301) 415-2328; email [email protected].


I. Submitting Comments and Accessing Information

    Comments submitted in writing or in electronic form will be posted 
on the NRC Web site and on the Federal rulemaking Web site, http://www.regulations.gov. Because your comments will not be edited to remove 
any identifying or contact information, the NRC cautions you against 
including any information in your submission that you do not want to be 
publicly disclosed.
    The NRC requests that any party soliciting or aggregating comments 
received from other persons for submission to the NRC inform those 
persons that the NRC will not edit their contact information, and 
therefore, they should not include any information in their comments 
that they do not want publicly disclosed.
    You can access publicly available documents related to this action 
using the following methods:
     NRC's Public Document Room (PDR): The public may examine 
and have copied, for a fee, publicly available documents at the NRC's 
PDR, Room O1-F21, One White Flint North, 11555 Rockville Pike, 
Rockville, Maryland 20852.
     ADAMS: Publicly available documents created or received at 
the NRC are available online in the NRC Library at http://www.nrc.gov/

[[Page 2925]]

rm/adams.html. From this page, the public can gain entry into ADAMS, 
which provides text and image files of the NRC's public documents. If 
you do not have access to ADAMS or if there are problems in accessing 
the documents located in ADAMS, contact the NRC's PDR reference staff 
at 1-(800) 397-4209, (301) 415-4737, or by email to 
[email protected]. The Branch Technical Position paper is accessible 
under ADAMS Accession No. ML11300A194.
     Federal Rulemaking Web Site: Public comments and 
supporting materials related to this proposed Branch Technical Position 
paper can be found at http://www.regulations.gov by searching on Docket 
ID NRC-2012-0008.

II. 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 exported or imported 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 
    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 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 at 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 

    \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 of 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 correlate those 
numbers to different manufacturers' 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 

[[Page 2926]]

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 
U.S. 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 U.S. 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 avoiding additional and unnecessary radiation 
exposure to workers consistent with the ``as low as reasonably 
achievable'' (ALARA) requirement 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 U.S. 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 export and 
import records to ensure that licensees understand the NRC's 
application of ``U.S. origin'' and that the company is making an effort 
to amend its business practices to try to determine source origin (from 
user paperwork and communication) before an import occurs.
    This position is being distributed to all Agreement States and 
applicable NRC 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 10 CFR part 110 would 
not apply to such imports.
    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 10 CFR 
110.2, the guidance described herein will be used in the evaluation of 
the use of the general import license for disused sources.

III. Procedural Requirements

Paperwork Reduction Act

    This proposed policy statement does not contain new or amended 
information collection requirements subject to the Paperwork Reduction 
Act of 1995 (44 U.S.C. 3501 et seq.). Existing requirements were 
approved by the Office of Management and Budget, approval number 3150-

Public Protection Notification

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

Congressional Review Act

    In accordance with the Congressional Review Act (5 U.S.C. 801-808), 
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.

    Dated at Rockville, Maryland, this 17th day of January 2012.

    For the Nuclear Regulatory Commission.
Margaret M. Doane,
 Director, Office of International Programs.
[FR Doc. 2012-1209 Filed 1-19-12; 8:45 am]