[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]
=======================================================================
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\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 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\
---------------------------------------------------------------------------
\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\
---------------------------------------------------------------------------
\3\ Import and Export of Radioactive Waste, 60 FR 37556 (July
21, 1995).
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\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 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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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:
---------------------------------------------------------------------------
\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
---------------------------------------------------------------------------
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