[Federal Register Volume 78, Number 167 (Wednesday, August 28, 2013)]
[Rules and Regulations]
[Pages 53020-53025]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-20975]


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NUCLEAR REGULATORY COMMISSION

10 CFR Part 110

[NRC-2012-0008]


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

AGENCY: U.S. Nuclear Regulatory Commission.

ACTION: Final Branch Technical Position.

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SUMMARY: In 2010, the U.S. Nuclear Regulatory Commission (NRC) staff 
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'' to confirm that the return of U.S. origin 
radioactive sources is not classified as the import of radioactive 
waste. The NRC staff drafted the Branch Technical Position (BTP) on the 
Import of Non-U.S. Origin Sources to provide additional guidance on the 
application of this exclusion in the regulations.
    In developing this BTP, the NRC staff has engaged with States, Low-
Level Waste Compacts, industry, and the public by providing two 
opportunities for public comment via Federal Register Notice and a 
public meeting in 2012. The exclusion in 10 CFR part 110 reflects the 
United States' commitments to the policy of safe storage and disposal 
of disused sources in the international context, including under the 
Code of Practice on the International Transboundary Movement of 
Radioactive Waste (Code of Practice), Joint Convention on the Safety of 
Spent Fuel Management and the Safety of Radioactive Waste Management 
(Joint Convention), and the International Atomic Energy Agency's (IAEA) 
Code of Conduct on the Safety and Security of Radioactive Sources (Code 
of Conduct--along with the supplementary Guidance on Import and 
Export). The United States' commitments include not exporting 
radioactive waste to other countries for disposal and, in light of the 
United States' strong domestic regulatory program, allowing return of 
disused sources manufactured or distributed from the United States in 
order to prevent sources from being orphaned overseas where regulatory 
programs may not exist or function to an optimal level.

DATES: The BTP is effective on September 27, 2013.

ADDRESSES: You can access publicly available documents related to this 
document using the following methods:
    Federal e-Rulemaking Portal: Go to http://www.regulations.gov and 
search for documents filed under Docket ID [NRC-2007-0009]. Address 
questions about NRC dockets to Ms. Carol Gallagher at 301-492-3668 or 
by email [email protected].
    NRC's Public Document Room (PDR): The public may examine and have 
copied, for a fee, publicly available documents at the NRC's PDR, 
Public File Area O1 F21, One White Flint North, 11555 Rockville Pike, 
Rockville, Maryland, 20852.
    NRC's Agencywide Documents Access and Management System (ADAMS): 
Publicly available documents created or received at the NRC are 
available electronically at the NRC's electronic Reading Room at http://www.nrc.gov/reading-rm/adams.html. From this page, the public can gain 
entry into ADAMS, which provides text and image files of 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].

FOR FURTHER INFORMATION CONTACT: Jennifer C. Tobin, Office of 
International Programs, U.S. Nuclear Regulatory Commission, MS-O4E21, 
Washington, DC 20555-0001; telephone: (301) 415-2328; email: 
[email protected].

SUPPLEMENTARY INFORMATION:

I. History
II. Branch Technical Position
III. Analysis of Public Comments on Proposed Branch Technical 
Position

I. History

    The NRC published ``Notice of Public Meeting and Request for 
Comment on the BTP on the Import of Non-U.S. Origin Radioactive 
Sources,'' 77 FR 2924 (January 20, 2012), and received five comment 
letters as a result of that publication. The NRC staff made no 
substantive changes to the draft BTP based on these comment letters. 
However, minor editorial changes were made to the draft BTP to provide 
greater clarity.
    The NRC published ``Request for Comment on the BTP on the Import of 
Non-U.S. Origin Radioactive Sources,''

[[Page 53021]]

77 FR 64435 (October 22, 2012), and received eight comment letters as a 
result of that publication. Many of those comments were on the existing 
regulations (10 CFR part 110) rather than the BTP. This final BTP does 
not amend the regulations in 10 CFR part 110; rather, it clarifies what 
is meant by ``U.S. origin'' and explains how the NRC staff interprets 
this exclusion to the definition of ``radioactive waste'' as used in 10 
CFR 110.2. The NRC staff response to the eight comment letters can be 
found in this Federal Register Notice as well as at ML13177A163.

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,'' establish 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 
(returned) 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 staff has developed this BTP to provide guidance to source 
manufacturers, distributors, or other entities on the NRC's application 
of the sealed source exclusion to imports into the United States 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\
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    \3\ Import and Export of Radioactive Waste, 60 FR 37556 (July 
21, 1995).
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    In September 1990, the IAEA General Conference adopted the Code of 
Practice on the International Transboundary Movement of Radioactive 
Waste (Code of Practice) which provides that ``[t]he sending State 
should take the appropriate steps necessary to permit readmission into 
its territory of any radioactive waste previously transferred from its 
territory if such transfer is not or cannot be completed in conformity 
with this Code . . ., unless an alternate safe arrangement can be 
made.'' This Code of Practice served as a basis for the sealed source 
exclusion in the 1992 proposed rule (57 FR 17859) that described a 
United States policy of encouraging the return of disused sources to 
the country of origin for the purposes of helping to ensure that the 
sources will be handled responsibly at the end of their life cycle. The 
regulatory history of this rule, finalized in 1995 (60 FR 375567), was 
in principal and intent identical to the sealed source exclusion 
embraced by the proposed rule. In the Statements of Consideration, the 
NRC described industry practice as limited to return of disused sources 
to the original supplier or country of origin.
    Shortly thereafter, the adoption of the Code of Practice resulted 
in the international development of the Joint Convention on the Safety 
of Spent Fuel Management and the Safety of Radioactive Waste Management 
(Joint Convention) that opened for signature in September 1997 and 
entered into force in 2001. In terms of this BTP, a key point in the 
legally-binding Joint Convention to which the United States is a party, 
is found in Article 28, ``Disused Sealed Sources,'' which states:

    ``A Contracting Party shall allow for reentry into its territory 
of disused sealed sources if, in the framework of its national law, 
it has accepted that they be returned to a manufacturer qualified to 
receive and possess the disused sealed sources.''

    Nearly identical language was included in the non-legally binding 
Code of Conduct on the Safety and Security of Radioactive Sources (Code 
of Conduct), along with the supplementary Guidance on Import and 
Export, that was internationally approved in 2003 and to which the 
United States made a political commitment in 2004. In accordance with 
the Code of Practice, the Joint Convention, and the Code of Conduct 
(including the supplemental Guidance on Import and Export), 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

[[Page 53022]]

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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    \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 NRC staff's attention that, 
while it remains a widespread industry practice to exchange new and 
disused sources on a ``one-for-one'' basis, the current global supply 
market does not always allow 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. The result is still a ``one-for-
one'' exchange, resulting in the number imported not being greater than 
new sources exported.
    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 manufacturer's coding patterns.

C. Regulatory Position

    The NRC staff has construed the ``U.S. origin'' provision in the 
context of the industry's recent clarification of international source 
exchange practices. The NRC staff 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 and without exposing personnel to additional 
doses, 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, 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 BTP 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 staff 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 staff expects U.S. manufacturers, distributors, and 
suppliers to make a good faith effort to determine source origin before 
an import occurs. A good faith effort by the importer includes, but is 
not limited to, communication of U.S. import requirements with its 
foreign customers, examination of a photograph of the source the 
customer seeks to exchange, and obtaining other relevant information 
related to the disused sources' origin. It is recommended that U.S. 
importers retain copies of their communications with their foreign 
customers regarding U.S. import requirements. At all times, the U.S. 
importer 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. The specific license requirements include meeting the 
provisions/conditions of the material possession license which may 
limit the quantity/activity held in storage on site. Licensees should 
consider the potential ramifications and costs of extended storage due 
to lack of disposal options. Licensees should recognize that the low-
level radioactive waste compacts have legal jurisdiction for the 
availability and access to disposal options.
    Consistent with 10 CFR 110.53, the NRC staff 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.''
    This position was distributed to all Agreement States and material 
licensees as a proposed document for comment and is publicly available 
for use by all potentially affected parties. Additionally, the NRC 
staff has coordinated this position with the Department of Energy/
National Nuclear Safety Administration's (DOE/NNSA) Global Threat 
Reduction Initiative (GTRI) and confirmed that NRC does not have 
jurisdiction over the GTRI program.

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.

III. Analysis of Public Comments on Proposed Branch Technical Position

    The NRC received responses from eight organizations including 
States, licensees, and others on the proposed BTP on the Import of Non-
U.S. Origin Radioactive Sources, 77 FR 64435 (October 22, 2012) that 
was published for a 60-day public comment period. The commenters were: 
the Northwest Interstate Compact on Low-Level Radioactive Waste 
Management (Northwest Compact), the State of Utah's Department of 
Environmental Quality (UDEQ), the State of Virginia's Department of 
Health-Division of Radiological Health (State of Virginia), the 
Organization of Agreement States (OAS), the Nuclear Energy Institute 
(NEI), the International Source Suppliers and Producers Association 
(ISSPA), QSA Global Inc. (QSA), the Low-Level Radioactive Waste Forum 
Inc.-Disused Sources Working Group (LLW Forum), and International 
Isotopes Inc. (International Isotopes).
    Most of the comments did not disagree with the underlying rationale 
for the regulation in Part 110 and justification for the BTP's 
interpretation (i.e., to construe non-U.S. origin disused

[[Page 53023]]

sources as U.S. origin under certain circumstances for purpose of 
exclusion one to the definition of radioactive waste in 10 CFR 110.2.) 
Instead, many of the comments appear to request that NRC revise or 
clarify the existing exclusions to the definition of radioactive waste 
in Part 110. Although only minimal changes are being made to the 
proposed BTP (mainly to provide more historical background and context 
and to explicitly point out costs and access to limited disposal 
options), the NRC staff found the comments useful in identifying 
concerns and is formally responding to those comments in conjunction 
with publication of the final BTP in the Federal Register.

Comment Response

    Comment: Four commenters (NEI, OAS, ISSPA, and the State of 
Virginia) agreed with the guidance provided in the proposed BTP and 
urged NRC staff to publish the final document in the Federal Register 
in the near future.
    Response: The comment resolution document will be published in the 
Federal Register in conjunction with the final BTP.
    Comment: International Isotopes and NEI requested that 
clarification regarding disused sources containing byproduct material 
as defined under section 11e(3) or section 11e(4) of the Atomic Energy 
Act be included in the BTP. The commenters asked for ``additional 
language to be added to the BTP to address the import of non-U.S. 
origin sources containing accelerator produced radioisotopes or Radium-
226 which can be disposed of in non-Part 61 or equivalent facilities'' 
as it was unclear to them if ``equivalent facility'' could include 
Resource Conservation and Recovery Act (RCRA) facilities.
    To address this concern, International Isotopes suggested that a 
footnote be added to the BTP such as the following:

    ``Non-U.S. origin radioactive sources containing byproduct 
material, as defined in paragraphs (3) and (4) of the definition of 
``byproduct material'' set forth in 20.1003, does not require a 
specific import license if it [the material] is intended for 
disposal at a disposal facility authorized to dispose of such 
material in accordance with any Federal or State solid or hazardous 
waste law, including the Solid Waste Disposal Act, as authorized 
under the Energy Policy Act of 2005.''

    Response: Any disused source imported for disposal in a RCRA 
facility would not be treated as ``radioactive waste'' under NRC's 
definition of radioactive waste found in 10 CFR part 110.2 since it is 
not being disposed of in a Part 61, Part 40 (Appendix A) or equivalent 
facility. Conversely, any disused source imported for disposal in a 
Part 61 or Part 40 (Appendix A), or equivalent facility, even if it 
contains section 11e(3) or section 11e(4) material, would qualify as 
radioactive waste under the Part 110 definition of ``radioactive 
waste'' since disposal would ``. . . require a specific radioactive 
material license in accordance with this Chapter and is imported or 
exported for the purposes of disposal in a land disposal facility . . 
.'' pursuant to NRC's regulations. The term ``equivalent facility'' 
used here refers to Part 61 equivalent facilities in foreign countries 
for export purposes and does not relate to import of disused sources. 
This clarification is not directly related to the discussion of U.S. 
origin in the BTP and therefore has been included as a frequently asked 
question (FAQ) on NRC's Web site at http://www.nrc.gov/about-nrc/ip/faq.html.
    Comment: QSA requested that the final BTP include clarification of 
Footnote 1 in the BTP.\6\ Specifically, QSA commented that:
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    \6\ 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.''

    ``We understood that the draft BTP was going to further clarify, 
that if a non-U.S. origin source is contained in a U.S. device, and 
that U.S. device needs to be returned to the U.S. for use, then that 
can be considered a legitimate import regardless of the source 
origin. We suggest the BTP add further clarification on this point 
for sources returned in a device under footnote 1. This change will 
continue to support international commerce, and will not impose 
unfair competitive restrictions on U.S. manufacturers since many 
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other countries do not have this restriction.''

    QSA explained that disused sources (both U.S. and foreign origin) 
are loaded into U.S. shipping containers, presumably when customers 
order replacement sources and if they have limited or no storage 
capacity for spent sources. QSA's interpretation of ``U.S. origin'' 
devices include U.S. shipping containers. Specifically, QSA uses the 
terms ``device'' and ``shipping container'' interchangeably in the 10 
CFR 110.2 definition of ``radioactive material.''
    The NRC staff believes that the guidance for ``U.S. origin'' in 
Footnote 1 is clearly addressing medical, industrial, or other types of 
sources that are included in devices. For those radiographic exposure 
devices, as defined in 10 CFR 34.3, which meet the performance 
requirement of 10 CFR 34.20(b)(2) and qualify as Type B transport 
containers in accordance with the applicable requirements of 10 CFR 
part 71, the radiographic exposure device houses the source and is 
integral to the use of the material for its intended purpose. The 
sealed source exclusion is applicable as is the ``one-for-one'' 
discussion. These are not the same as shipping containers that are used 
solely for transferring new or used sources. NRC does not consider a 
Type B shipping container that is not integral to the use of the 
material for its intended purpose to be a device, as the term is 
commonly used and understood in NRC's domestic regulatory program. A 
device typically only contains one source whereas a shipping container 
can include a number of sources with different origins. All of the 
sources in the shipping container need to be taken into account in the 
one-to-one exchange and determining origin.
    Comment: The LLW Forum requested that further interactions with the 
NRC take place regarding the first and sixth exclusions of the 
definition of ``radioactive waste'' in 10 CFR 110.2. The first 
exclusion addresses U.S. origin. The sixth exclusion concerns 
legitimate recycling of radioactive sources.
    Response: As stated in the final rule, the NRC added a sixth 
exclusion to the definition of ``radioactive waste'' to clarify that 
the definition does not include material imported solely for the 
purposes of recycling and not for waste management or disposal where 
there is a market for the recycled material and evidence of a contract 
or business agreement can be produced upon request by the NRC.
    In addition to the LLW Forum's comment, the NRC also received 
several questions from industry regarding the applicability of the 
sixth exclusion to long-lived isotopes sealed in radioactive sources. 
Specifically, the NRC has been asked for clarification on the 
applicability of exclusion six in cases where sources were imported for 
recovery and reuse of the radioactive material but, upon import, due to 
the condition of the source or device, it was determined that the 
material could not be recovered or reused as intended. The NRC staff 
recognizes that in some circumstances sources imported with the intent 
to recycle may be discovered to be not recyclable. The NRC staff 
construes the sixth exclusion in 10 CFR 110.2 to authorize import for 
recycle

[[Page 53024]]

and/or reuse under the general license to apply in a situation where, 
based on the best available information and after a good faith effort 
to determine recyclability of the source(s) prior to the import taking 
place, a U.S. company imports a source with the intent of recovering 
the radioactive material for reuse in another application but upon 
import discovers that a source is not recyclable. A good faith effort 
by the importer includes, but is not limited to, communication of U.S. 
import requirements with its foreign customers, examination of a 
photograph of the source(s) the customer seeks to exchange, and other 
relevant information related to the source's recyclability such as 
current activity level.
    At all times, the U.S. importer must comply with the specific 
license requirement for ``radioactive waste'' as defined in 10 CFR 
110.2. Any person who imports materials under a general license for 
recycling using exclusion six, but with the intent of disposing of that 
material in the United States would be subject to NRC enforcement 
action. In addition, there may be instances in which some small value 
may be obtained from the materials that are imported, but the primary 
intention is for disposal. In such cases, to avoid possible enforcement 
action the NRC staff should be consulted before any such imports are 
made. It is recommended that U.S. importers retain copies of their 
communications with their foreign customers regarding U.S. import 
requirements and records of efforts taken to determine recyclability of 
the source(s) prior to import. This guidance is also posted as an FAQ 
on the import/export Web site at http://www.nrc.gov/about-nrc/ip/faq.html.
    Comment: The Northwest Compact pointed out that NRC's definition of 
radioactive waste to exclude U.S. origin disused sources is not 
consistent with the Compact's definition of radioactive waste in its 
``Resolution Clarifying the Third Amended Resolution and Order,'' which 
the Compact claims requires treating U.S.-manufactured disused sources 
that are used outside the U.S. as foreign radioactive waste. According 
to the Northwest Compact:

    ``A depleted sealed source means that the useful life of the 
returned radioactive sealed sources is exhausted or used up which 
means the Compacts would view such sources as radioactive waste. 
Following purchase from a U.S. manufacturer, the source spent its 
entire useful life employed for its specific purpose in the foreign 
country. So although the BTP would allow such sources to be returned 
to the manufacturer as material, in reality the radioactive sealed 
source actually became waste following its use within a foreign 
country, prior to its return to the U.S. manufacturer.''

    Furthermore, The Northwest Compact stated that:

    ``It is difficult to envision the return of a ``depleted'' 
radioactive sealed source as anything other than the return of waste 
that was generated within a foreign country. Without such a policy, 
there is little incentive for out-of-region states or foreign 
countries to develop the capacity to properly handle radioactive 
sealed sources following their useful life.''

    The Northwest Compact recommended that the NRC add a statement such 
as the following to the BTP:

    ``Returned sources may have limited disposal access as the 
interstate compacts in which three of the four operating Part 61 
commercial disposal facilities in the U.S. are located may view the 
returned radioactive sealed sources as foreign low-level waste and 
would not provide access for disposal.''

    Response: The NRC disagrees that a U.S.-manufactured source that 
was used outside the U.S. should be treated as foreign-generated 
radioactive waste for purposes of import under Part 110. As stated in 
the BTP, facilitating return of U.S.-manufactured disused sources 
through the use of a general license, among other things, furthers 
international policy objectives regarding disused sources committed to 
by the United States, including the United States' implementation of 
the Code of Conduct. Specifically, paragraph 27 of the Code of Conduct 
states:

``Every State should allow for re-entry into its territory of 
disused radioactive sources if, in the framework of its national 
law, it has accepted that they be returned to a manufacturer 
authorized to manage the disused sources.''

    The return of disused sources to the country of origin is a well-
established industry practice not only in the United States but in many 
other countries. Global implementation of the Code of Practice, Joint 
Convention, and Code of Conduct (including the supplementary Guidance 
on Import and Export) provides responsible end-of-life management for 
all international parties (see Background section of BTP for additional 
details). The practice of allowing return to the U.S. under general 
license of U.S.-manufactured disused sources has been in use in the 
United States at least since the mid-1990's.
    The NRC staff recognizes that differences in interpretation of the 
meaning of ``foreign'' radioactive waste may limit disposal options for 
licensees. The Northwest Compact's current ``Resolution Clarifying the 
Third Amended Resolution and Order'' would appear not to allow sources 
used in foreign jurisdictions (to the end of useful life) to be 
disposed of at a Compact facility even if a source originated in a 
Northwest Compact member state and is considered to be ``U.S. origin'' 
and excluded from the definition of radioactive waste by the NRC for 
purposes of import. The Northwest Compact thus purports to have the 
authority to prevent return to the U.S. of disused sources originating 
in the U.S. but used in a foreign country.
    The NRC staff believes that the Northwest Compact's interpretation 
of country of origin and what is ``foreign'' waste is inconsistent with 
the commonly understood and accepted interpretation of country of 
origin for disused sources (i.e., the country where the disused sources 
were manufactured rather than used) under the international agreements 
to which the U.S. is a signatory, including the Code of Practice, the 
Joint Convention, and the Code of Conduct, all of which expect that 
signatory countries be responsible for the disposition of disused 
sources originating within their own country.
    To the extent that the Northwest Compact is suggesting that its 
Compact authority may be exercised in a manner that is contrary to 
federal law, including NRC regulations, and underlying U.S. policy 
objectives to promote responsible handling of disused sources on an 
international scale, the NRC staff disagrees. Section 4(b)(4) of the 
Low Level Radioactive Waste Policy Act of 1985, as amended, provides 
that, ``[e]xcept as expressly provided in this Act, nothing contained 
in this Act or any compact may be construed to limit the applicability 
of any Federal law or to diminish or otherwise impair the jurisdiction 
of any Federal agency. . . .'' The NRC staff questions whether 
application of the Northwest Compact's ``Resolution'' in a manner that 
would interfere with the federal scheme for responsible disposition of 
U.S. origin disused sources used overseas, including disused sources 
originating within a Northwest Compact member state, would be a 
permissible exercise of Compact authority consented to by Congress 
under the Northwest Interstate Compact on Low-Level Radioactive Waste 
Management. The NRC staff recognizes, however, that legal and policy 
issues regarding the interface between federal authority and state 
compact authority have yet to be tested in this particular context and, 
in any event, are beyond the scope of the BTP. We reiterate that the 
BTP itself is

[[Page 53025]]

consistent with the NRC rule regarding import and export of radioactive 
waste that has been in place since 1995, and, through its limitation to 
one-for-one exchanges, has a neutral effect on disposal capacity 
constraints within the U.S. The NRC staff also notes that the other 
nine Low-Level Waste Compacts and ten unaffiliated States have not 
expressed specific views on the waste management practices that apply 
to disused radioactive sources.
    By addressing this aspect of the Northwest Compact's comment in 
this comment resolution document (published at the same time as the 
BTP), the NRC is reiterating to licensees the potential limits both to 
disposal options for disused sources and long-term storage capacity at 
the licensees' respective sites.
    Comment: Three commenters (Northwest Compact, LLW Forum and UDEQ) 
would like additional language added to the BTP to acknowledge the lack 
of current disposal options for non-U.S. origin disused radioactive 
sources. UDEQ commented that ``[t]he importation of sources/devices not 
directly attributable to U.S.-origin certainly raises a concern 
regarding disposal site access in Utah.'' UDEQ suggested adding 
clarification to the BTP to state that where disposal of such sources 
is not an option, a licensee

``. . . would still be required to store these sources safely, to 
meet the financial assurance provisions as applicable in the 
regulations, and would have to dispose of the sources in an 
authorized facility at some time. The DEQ staff expects that 
licensees would consider the additional costs for potential storage 
and out-of-compact disposal in deciding whether to import sources . 
. .''

    UDEQ also suggested adding more explanatory text regarding 
potential storage and disposal considerations and requirements directly 
into the BTP as a clarifying footnote. The Northwest Compact and LLW 
Forum raised similar concerns about potential impacts on capacity for 
domestic long-term storage and ultimate disposal by NRC and Agreement 
State licensees. Specifically, the LLW Forum observed that

``. . . although NRC may allow certain radioactive sources to be 
imported into the country under the proposed BTP, the agency should 
be aware that there may not be a disposal option for the sources 
depending upon the policies of the particular Compact and/or sited 
state to which the sources are being returned.''

    Response: A specific license for the import of radioactive waste 
must ``. . . name an appropriate facility that has agreed to accept and 
is authorized to possess the waste for management or disposal . . .'' 
(10 CFR 110.43(d) (emphasis added)) where ``management'' includes 
authorization for long-term storage under a company's NRC or Agreement 
State issued possession license. A general license (10 CFR 110.27) is 
contingent on ``the U.S. consignee [being] authorized to receive and 
possess the material under a general or specific NRC or Agreement State 
license . . .'' Among other things, the domestic authorization sets 
possession limits and provisions for long-term storage. The NRC staff 
is aware that there may not be disposal options for some sources due to 
current Compact policies on admittance of out-of-Compact waste.
    Agreement State and NRC possession license holders historically 
have not differentiated use or storage of radioactive sources based on 
origin. In terms of their possession limits and storage capacity, 
licensees handle the sources identically regardless of origin in order 
to protect public health and safety. With the ``one-for-one'' exchange 
required under the BTP, there should be no increase in the volume of 
disused sources for management or disposal as a result of the BTP. The 
application of this BTP is limited to those radioactive sources that 
have been exchanged on a ``one-for-one'' basis and after a good faith 
effort has been made by the importer to determine the origin. 
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.
    Comment: The Northwest Compact and the UDEQ suggested that the 
final BTP include language explicitly:

``. . . informing U.S. licensees to consider the ramifications and 
costs of the potential need for extended storage in the absence of a 
recycling or subsequent disposal option for imported sources and 
devices as well as the legal jurisdictions of low-level radioactive 
waste compacts in terms of the availability of or access to disposal 
activities.''

    Response: The NRC is aware that the costs of long term storage may 
be an issue for some licensees. For this reason, NRC has added language 
to the final BTP to reflect the Northwest Compact and State of Utah 
concerns regarding the availability and access to the limited disposal 
options currently available.
    Comment: The LLW Forum expressed that ``the NRC should show greater 
deference to the LLW Compacts and host states through earlier and more 
active involvement in the import of potentially non-U.S. origin 
radioactive sources for disposal.'' They suggest that:

``. . . when the NRC is in the process of developing policy 
positions on the disposal of disused sources, the NRC should 
evaluate whether the position is consistent with the policies of 
interstate compacts that host Part 61 commercial low-level 
radioactive waste disposal facilities and should also include 
consultation and communication with affected compacts and sited 
states.''

    Response: The NRC staff works within the confines of the Atomic 
Energy Act of 1954, as amended, and recognizes the authorities granted 
to the States and Compacts in the Low Level Waste Policy Act of 1985. 
The LLW Compacts are provided multiple opportunities to comment on 
publications for rulemaking in Part 110, Part 110 specific license 
applications for import of radioactive waste, and guidance documents 
such as the BTP (see pre-emption response above).
    Comment: International Isotopes suggested that the final BTP should 
``recognize the practice of a ``one-for-one'' source exchange and 
acknowledge that there are complexities associated the radioactive 
source supply chain.'' More specifically, International Isotopes points 
out that the timing of exports and imports over the course of a 
timeframe might not align specifically with the ``one-for-one'' 
principle on which the BTP is based.
    Response: The NRC staff recognizes that importing/exporting trends 
and an importer's intent are licensee and isotope-specific and will be 
considered on a case-by-case basis by NRC staff.

    Dated at Rockville, Maryland, this 22nd day of August, 2013.

    For the Nuclear Regulatory Commission.
Charlotte Abrams,
Acting Director, Office of International Program.
[FR Doc. 2013-20975 Filed 8-27-13; 8:45 am]
BILLING CODE 7590-01-P