[Federal Register Volume 73, Number 71 (Friday, April 11, 2008)]
[Proposed Rules]
[Pages 19749-19761]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-7756]
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Proposed Rules
Federal Register
________________________________________________________________________
This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.
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Federal Register / Vol. 73, No. 71 / Friday, April 11, 2008 /
Proposed Rules
[[Page 19749]]
NUCLEAR REGULATORY COMMISSION
10 CFR Parts 20 and 32
RIN 3150-AI29
[NRC-2008-0200]
Expansion of the National Source Tracking System
AGENCY: Nuclear Regulatory Commission.
ACTION: Proposed rule.
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SUMMARY: The Nuclear Regulatory Commission (NRC) is proposing to amend
its regulations to expand the current National Source Tracking System
(NSTS) to include certain additional sealed sources. The proposed
amendments would require licensees to report certain transactions
involving these sealed sources to the NSTS. These transactions would
include the manufacture, transfer, receipt, disassembly, or disposal of
the nationally tracked source. The proposed amendment would also
require each licensee to provide its initial inventory of nationally
tracked sources to the NSTS and annually verify and reconcile the
information in the system with the licensee's actual inventory.
DATES: Submit comments on the proposed rule by June 25, 2008. Submit
comments specific to the information collection aspects of this rule by
May 12, 2008. Comments received after the above date will be considered
if it is practical to do so, but the NRC is able to assure
consideration only for comments received on or before this date.
ADDRESSES: You may submit comments on the rule by any one of the
following methods. Please include the number RIN 3150-AI29 in the
subject line of your comments. Comments on rulemakings submitted in
writing or in electronic form will be made available to the public in
their entirety in NRC's Agencywide Document Access and Management
System (ADAMS). Personal information, such as your name, address,
telephone number, e-mail address, etc., will not be removed from your
submission.
Mail comments to: Secretary, U.S. Nuclear Regulatory Commission,
Washington, DC 20555-0001, ATTN: Rulemakings and Adjudications Staff.
E-mail comments to: [email protected]. If you do not
receive a reply e-mail confirming that we have received your comments,
contact us directly at 301-415-1677. Comments can also be submitted via
the Federal eRulemaking Portal http://www.regulations.gov, docket
NRC-2008-0200.
Hand deliver comments to: 11555 Rockville Pike, Rockville, Maryland
20852, between 7:30 a.m. and 4:15 p.m. Federal workdays (Telephone 301-
415-1677).
Fax comments to: Secretary, U.S. Nuclear Regulatory Commission at
301-415-1101.
You may submit comments on the information collections by the
methods indicated in the Paperwork Reduction Act Statement.
Publicly available documents related to this rulemaking may be
viewed electronically on the public computers located at the NRC's
Public Document Room (PDR), O1 F21, One White Flint North, 11555
Rockville Pike, Rockville, Maryland. The PDR reproduction contractor
will copy documents for a fee.
Publicly available documents created or received at the NRC after
November 1, 1999, are available electronically at the NRC's Electronic
Reading Room at http://www.nrc.gov/reading-rm/adams.html. From this
site, 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 PDR Reference staff at 1-800-397-4209, 301-415-4737
or by e-mail to [email protected].
FOR FURTHER INFORMATION CONTACT: Michael Williamson, Office of Federal
and State Materials and Environmental Management Programs, U.S. Nuclear
Regulatory Commission, Washington, DC 20555-0001, telephone (301) 415-
6234, e-mail, [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
II. Discussion
A. Rationale for Expanding the NSTS To Include Additional Source
Categories
B. Enhanced Accountability Provided by These Amendments
C. Other Considerations
D. General Content of the Proposed Rule
III. Discussion of Proposed Amendments by Section
IV. Criminal Penalties
V. Agreement State Compatibility
VI. Plain Language
VII. Voluntary Consensus Standards
VIII. Environmental Impact: Categorical Exclusion
IX. Paperwork Reduction Act Statement
X. Public Protection Notification
XI. Regulatory Analysis
XII. Regulatory Flexibility Certification
XIII. Backfit Analysis
I. Background
After the terrorist attacks in the United States on September 11,
2001, the NRC conducted a comprehensive review of nuclear material
security requirements, with particular focus on radioactive material of
concern. This radioactive material (which includes Cobalt-60, Cesium-
137, Iridium-192, and Americium-241, as well as other radionuclides)
has the potential to be used in a radiological dispersal device (RDD)
or a radiological exposure device (RED) in the absence of proper
security and control measures. The NRC's review took into consideration
the changing domestic and international threat environments and related
U.S. Government-supported international initiatives in the nuclear
security area, particularly activities conducted by the International
Atomic Energy Agency (IAEA).
In June 2002, the Secretary of Energy and the NRC Chairman met to
discuss the adequate protection of inventories of nuclear materials
that could be used in a RDD. At the June meeting, the Secretary of
Energy and the NRC Chairman agreed to convene an Interagency Working
Group on Radiological Dispersal Devices to address security concerns.
In May 2003, the joint U.S. Department of Energy (DOE)/NRC report was
issued. The report was entitled, ``Radiological Dispersal Devices: An
Initial Study to Identify Radioactive Materials of Greatest Concern and
Approaches to Their Tracking, Tagging, and Disposition.'' One of the
report's recommendations is development of a national source tracking
system to better understand and monitor the location
[[Page 19750]]
and movement of sources of interest. The full report contains a list of
radionuclides and thresholds above which tracking of the sources is
recommended.
The NRC has also supported U.S. Government efforts to establish
international guidance for the safety and security of radioactive
materials of concern. This effort has resulted in a major revision of
the IAEA Code of Conduct on the Safety and Security of Radioactive
Sources (Code of Conduct). The revised Code of Conduct was approved by
the IAEA Board of Governors in September 2003, and is available on the
IAEA Web site. In particular, the Code of Conduct contains a
recommendation that each IAEA Member State develop a national source
registry of radioactive sources that includes at a minimum Category 1
and Category 2 radioactive sources as described in Annex 1 of the Code
of Conduct. The source registry recommendation addressed 16
radionuclides.
The work on the DOE/NRC joint report was done in parallel with the
work on the Code of Conduct and the development of IAEA TECDOC-1344,
``Categorization of Radioactive Sources.'' The IAEA published this
categorization system for radioactive sources in August 2005 in its
Safety Series as RS-G-1.9, Categorization of Radioactive Sources. The
report, available on the IAEA Web site, provides the underlying
methodology for the development of the Code of Conduct thresholds. The
categorization system is based on the potential for sources to cause
deterministic effects and uses the `D' values as normalizing factors.
The `D' values are radionuclide-specific activity levels for the
purposes of emergency planning and response. The quantities of concern
identified in the DOE/NRC report are similar to the Code of Conduct
Category 2 threshold values, so to allow alignment between domestic and
international efforts to increase the safety and security of
radioactive sources, NRC has adopted the Category 2 values. The NRC
considers IAEA Category 2 (and higher) to be risk-significant
radioactive material that has a potential to result in significant
adverse impacts that could reasonably constitute a threat to the public
health and safety, the environment, or the common defense and security
of the United States.
Subsequently, the NRC published a final rule in the Federal
Register on November 8, 2006 (71 FR 65686), establishing a national
system for source tracking. Under this program, certain licensees who
possess IAEA Category 1 and 2 sources are required to report
information on the manufacture, transfer, receipt, disassembly, and
disposal of nationally tracked sources. This information is to be used
to support the National Source Tracking System (NSTS) and will provide
the NRC with a life cycle account for these sources and, thus, improve
accountability and controls over them. The final rule establishing the
NSTS reflected the IAEA Code of Conduct recommendations that are
consistent with the NRC's responsibilities under the Atomic Energy Act,
including the protection of the public health and safety. The
implementation date for the NSTS has been extended to January 31, 2009
(72 FR 59162).
The principal purpose of the NSTS is to provide reasonable
assurance of timely detection of either the theft or diversion of
radioactive materials sufficient to constitute quantities which should
be of concern regarding the construction of a radiological dispersion
device. This is consistent with one of the objectives of the Code of
Conduct which is to prevent unauthorized access or damage to, and loss,
theft or unauthorized transfer of, radioactive sources.
In the 2005 proposed rulemaking, the Commission specifically
invited comments on whether Category 3 sources should be included in
the NSTS. In response to the public comments received, the Commission
indicated that it was deferring a final determination on what
additional sources should be included in the NSTS to a subsequent
rulemaking (71 FR 65692). The Commission is now conducting that
subsequent rulemaking.
II. Discussion
In this rulemaking, NRC is proposing to amend its regulations to
expand the NSTS to require licensees to report information on the
manufacture, transfer, receipt, disassembly, and disposal of additional
nationally tracked sources. In determining whether to expand the NSTS
to include additional sources, the NRC has considered the need to
balance the secure handling and use of the materials without
discouraging their beneficial use in academic, medical, and industrial
applications. Radioactive materials provide critical capabilities in
the oil and gas, electrical power, construction, and food industries;
are used to treat millions of patients each year in diagnostic and
therapeutic procedures; and are used in technology research and
development involving academic, government, and private institutions.
These materials are as diverse in geographical location as they are in
functional use.
Expanding the NSTS is part of a comprehensive radioactive source
control program for radioactive materials of greatest concern, as
discussed SECY-07-0147, ``Response to U.S. Government Accountability
Office Recommendations and other Recommendations to Address Security
Issues in the U.S. NRC Materials Program,'' dated August 25, 2007.
Although neither the currently planned NSTS, nor an expanded NSTS, can
ensure the physical protection of sources, the NSTS can provide greater
source accountability and, as part of an overall effort, in conjunction
with other related activities (e.g., web based licensing, pre-licensing
site visits, and increased controls orders), improve the control of
radioactive sources and protect public health and safety, as well as
common defense and security.
Section II of this preamble discusses the overall rationale for
expanding the NSTS to include additional sources (Section II.A); how
these amendments can improve accountability of sources (Section II.B);
and other considerations (Section II.C). The general content of the
proposed rule is discussed in Section II.D.
A. Rationale for Expanding the NSTS To Include Additional Source
Categories
A.1 Congressional Concerns/GAO Investigations
Concerns by members of the U.S. Congress, and the Government
Accountability Office (GAO), have been expressed regarding the
aggregation of lower activity sources whose activity level, if taken
together, could exceed the Category 2 threshold. Although a GAO
investigation involved obtaining sources lower than Category 3 (i.e.,
in the low range of Category 4), the concerns expressed by members of
Congress and the GAO over security issues associated with the NRC
materials program have been considered in this rulemaking.
Specifically, as a result of an investigation, GAO stated in its report
(GAO Testimony, GAO-07-1038T, ``Actions Taken by NRC to Strengthen Its
Licensing Process for Sealed Radioactive Sources'', July 12, 2007) that
NRC should regulate Category 3 sources more stringently (Recommendation
B of the report) and that NRC should consider including Category 3
sources in the NSTS (Recommendation B.2).
[[Page 19751]]
A.2 Recent NRC Actions
In addition to the issues noted by the GAO, the NRC staff prepared
SECY-06-0094, ``Tracking or Providing Enhanced Controls for Category 3
Sources,'' April 24, 2006, for the Commission's review. This paper
contained options for tracking and/or providing enhanced controls for
Category 3 sources. In response to that paper, the Commission provided
direction to the NRC staff in SRM-SECY-06-0094, dated June 9, 2006,
regarding enhanced controls for Category 3 sources. Specifically, the
SRM noted that the staff should submit a proposed rule for the
Commission to consider including Category 3 data in the NSTS.
Subsequently, in response to Recommendations B and B.2 of the GAO
report discussed in this preamble, NRC staff provided the Commission
with an Action Plan in SECY-07-0147. The Action Plan, entitled ``Action
Plan to Respond to Recommendations to Address Security Issues in the
U.S. NRC Materials Program,'' included, as Recommendation S-2b, an
action that the scope of the NSTS rulemaking be expanded to include
sources at a level of \1/10\ of Category 3. The Commission approved the
staff's Action Plan on September 18, 2007, in SRM-SECY-07-0147.
A.3. Considerations Regarding the Need for Expanding the NSTS and the
Extent to Which the NSTS Should Be Expanded, i.e., What Categories (or
Sub-Groups of Categories) of Sources To Be Included
A.3.1 The Five IAEA Categories and the Relative Health and Safety Risk
Posed by Sources in Those Categories
The IAEA source categorization scheme includes five categories.\1\
These categories are based on the potential for sources to cause
deterministic health effects to persons exposed to them. Sources in
Category 1 are considered to be the most `dangerous' because they can
pose a very high risk to human health if not managed safely and
securely. At the lower end of the categorization system, sources in
Category 5 are the least dangerous; however, even these sources could
give rise to doses in excess of the dose limits if not properly
controlled. Based on analysis of potential health effects, each of the
IAEA Categories contain radioactive material in sealed sources in
quantities that can be characterized as follows:
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\1\ RS-G-1.9 ``Categorization of Radioactive Sources.''
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Category 1: greater than or equal to the Category 1 threshold
(e.g., for Cobalt-60 (Co-60): 810 Curies (Ci)); these sources are
typically used in practices such as radiothermal generators,
irradiators and radiation therapy.
Category 2: less than the Category 1 threshold but equal to or
greater than the Category 2 threshold (which is \1/100\ of Category 1)
(e.g., for Co-60: 8.1 Ci); these sources are typically used in
practices such as industrial gamma radiography and high and medium dose
rate brachytherapy.
Category 3: less than the Category 2 threshold but equal to or
greater than the Category 3 threshold (\1/10\ of Category 2) (e.g., for
Co-60: 0.81 Ci); these sources are typically used in practices such as
fixed industrial gauges involving high activity sources.
Category 4: less than the Category 3 threshold but equal to or
greater than the Category 4 threshold (\1/100\ of Category 3) (e.g.,
for Co-60: 0.0081 Ci);
Category 5: less than the Category 4 threshold down to IAEA exempt
quantities.
The scope of IAEA's Code of Conduct on the Safety and Security of
Radioactive Sources is limited to Categories 1-3, i.e., those having
the highest potential to cause permanent injury or death when used in a
malevolent manner.
A.3.2 Rationale in the Existing NSTS Rule for Imposing the Requirement
To Track Category 1 and 2 Sources
In the rulemaking establishing the NSTS for Category 1 and 2
sources, specific rationale was provided for establishing tracking and
inventory requirements for Category 1 and 2 sources. In that
rulemaking, as discussed in Section I of this preamble, it was noted
that the DOE/NRC analysis of potential health effects from use of
sources in a RDD or a RED identified radionuclide ``quantities of
concern'' to be in a range similar to the IAEA Category 2 threshold
values. Therefore, to allow alignment between domestic and
international efforts to increase safety and security of radioactive
sources, NRC adopted the IAEA Category 2 values and used them as a
threshold in its rulemaking decision regarding sources requiring
tracking and inventorying in a national source tracking system.
A.3.3 Discussion in the Previous NSTS Rulemaking for Including
Additional IAEA Categories in the NSTS
In conducting the rulemaking to establish the NSTS, the Commission
noted that Category 3 sources could be included in the NSTS in the
future, citing the potential that a licensee possessing a large number
of Category 3 sources could present a security concern. Therefore, as
part of that rulemaking, the Commission sought comment and information
on the issue of including Category 3 sources in the NSTS. These
comments are summarized in Section II.C.2. Based on its review of those
comments, the Commission, in issuing the final rule to establish the
NSTS, noted that it did not have adequate information at that point in
time to support inclusion of Category 3 sources in the NSTS, however,
it also noted that it was working to develop additional information by
conducting a one-time survey of sources at a level of \1/10\ of
Category 3. The Commission then noted that, in that rulemaking, it was
not making a final determination on what additional sources should be
included in the NSTS and that if additional material is added to the
NSTS, it would be done through subsequent rulemaking. The Commission is
now conducting that subsequent rulemaking.
A.3.4. Rationale for Inclusion of Additional Sources in an Expanded
NSTS in This Rulemaking
In preparing this proposed rule, NRC has determined that there is a
need to enhance the tracking of lower activity sources to improve
accountability for these sources and to provide the ability to detect
situations where a licensee's aggregate sources would create larger
(more dangerous) quantities. At issue is the extent appropriate for
expanding the NSTS beyond Category 2, i.e., should the NSTS be expanded
to include IAEA Category 3 sources (as suggested in the June 9th, 2006
SRM) or should it be expanded even further to include sources that are
\1/10\ of the Category 3 threshold (as suggested in the August 25, 2007
Action Plan). Consideration was also given to expanding the NSTS to
include sources in the low end of Category 4 or in Category 5. The
rationales for expanding the NSTS to include Category 3 sources and to
include lower category sources are provided in Sub-Sections A.3.4.1 and
A.3.4.2, respectively.
A.3.4.1 Inclusion of Category 3 Sources in the NSTS
The Commission believes that it is clear that there is a need to
enhance the accountability and control of Category 3 sources (i.e.,
those that are greater than or equal to the IAEA Category 3 threshold)
through improved tracking of these sources. The following are the
principal rationale for the Commission's decision regarding Category 3
sources:
[[Page 19752]]
(a) Category 3 sources are defined as dangerous by IAEA: The IAEA
defines Category 3 sources (as well as the Category 1 and 2 sources) as
``dangerous sources'', i.e., a source that could if not under control
give rise to exposure sufficient to cause severe deterministic effects,
although it left to its individual member States whether it would be
necessary to actually set up a tracking system for these sources.
(b) There is potential for aggregation of Category 3 sources to a
Category 2 level: Category 3 sources could be easily aggregated to
Category 2 levels, as part of a concerted effort to do so, as they
represent sources with activity levels that range from just below the
Category 2 threshold down to \1/10\ of the Category 2 threshold. Thus,
sources at the high end of the range of activities in Category 3 can be
at levels just below the threshold of a Category 2 source, meaning that
it would take only a few sources to aggregate to Category 2. Adding
these sources to the NSTS with its inventory and tracking requirements
will provide for increased accountability for these sources because
there would a near real-time knowledge of source whereabouts and an
ability to confirm an individual licensee's account of their sources.
(c) Types of licensees that possess Category 3 sources: The major
categories of licensees who possess Category 3 sources include those
with fixed industrial gauges (level gauges, conveyor gauges, thickness
gauges, blast furnace gauges, dredger, pipe gauges); those who conduct
well-logging operations; medical facilities with brachytherapy
machines; and some radiographers with relatively low activity sources.
Because these sources are thus relatively widespread in use and
relatively broadly used in industry, there would be potential for
aggregation of sufficient numbers of them to Category 2 levels.
(d) Additional burden to comply with these requirements is
considered reasonable to incur for the benefit in improved source
accountability: Adding Category 3 sources to the NSTS would result in
increased burden to the NRC and to the licensed industry for
implementation and maintenance of the expanded NSTS. In the Regulatory
Analysis for this rulemaking (summarized in Section XI of this FRN),
the Commission analyzed the additional costs and benefits of expanding
the NSTS to Category 3 levels. As noted in the Regulatory Analysis, the
existing NSTS has approximately 1300 NRC and Agreement State licensees
and an expanded NSTS under this proposed rule to include Category 3
sources would add approximately 1000 licensees. As estimated in the
Regulatory Analysis, the resultant overall annual cost to the industry
and to the NRC would be approximately doubled as a result of this
expansion of the NSTS to Category 3, however the Commission believes
that this additional burden would be reasonable to incur given the
additional improvement in accountability for these sources.
(e) Additional sources can be accommodated by the NSTS: As noted in
Section II.C.1 of this preamble, the Commission believes that the
existing NSTS system can accommodate these additional licensees and
sources based on its expandability and flexibility and that, if NRC
applies the appropriate resources, that monitoring of the expanded NSTS
would not divert attention from the monitoring of higher-risk Category
1 and 2 sources.
(f) Consideration of earlier public comment: In reaching its
decision to include Category 3 sources, the Commission considered the
comments received regarding inclusion of Category 3 sources during the
rulemaking to establish the NSTS for Category 1 and 2 sources. These
comments are summarized in Section II.C.2 of this preamble. Briefly
stated, a number of commenters supported inclusion of Category 3
sources in the NSTS for some of the same reasons as previously noted,
whereas a larger number of commenters opposed the inclusion of Category
3 sources based on the relatively low risk they present compared to the
large increased burden of adding these sources to the NSTS. The
Commission believes that it has considered the concerns of the
commenters, pro and con, and evaluated the additional burdens which the
rule would impose, in reaching its decision.
Based on the considerations previously noted, the definition of
Category 3 as dangerous, and the potential for aggregation to Category
2, the Commission believes that the same information to be included in
the NSTS for Category 1 and Category 2 sources is also needed for
Category 3 sources. Expanding the scope of the NSTS will provide for
Category 3 sources the same single source of information as collected
for Category 1 and 2 sources. Although separate NRC and Agreement State
systems contain information on Category 3 source licensees and the
maximum amounts of materials they are authorized to possess, those
systems do not record actual sources or their movements.
Thus, to address this lack of information on such issues as actual
materials possessed, the NRC is proposing, as part of this proposed
rule, to expand the NSTS to include sources greater than or equal to
the IAEA Category 3 threshold levels. Expanding the NSTS to Category 3
sources would provide NRC with information regarding purchases/
transactions of sufficient numbers of Category 3 sources that could be
aggregated into the equivalent of Category 2 sources. Tracking specific
transactions of Category 3 sources enhances accountability and would
detect situations where a licensee's aggregate sources would create
larger (more dangerous) quantities.
A.3.4.2 Inclusion of Lower Category Sources in the NSTS, in Particular
\1/10\ of Category 3
The Commission has also given consideration to expanding the NSTS
to sources below the Category 3 threshold. Specifically, the staff
considered expanding the NSTS to include a subset of IAEA Category 4
sources that are in the high end of Category 4 (at a level of \1/10\ of
the Category 3 threshold). The staff also considered whether to expand
the NSTS to include all of Category 4 (the Category 4 threshold is \1/
100\ of the Category 3 threshold) and Category 5.
A principal rationale for including sources at the high-end of the
Category 4 range of activities (i.e., at \1/10\ of Category 3) is the
potential that a sufficient number of these higher-activity Category 4
sources could be obtained and aggregated to create the equivalent of
Category 2 sources. These ``high-end'' Category 4 sources can be at
levels just below the threshold of a Category 3 source, which is about
\1/10\ of the threshold of a Category 2 source, meaning that it would
require about 10-12 of these sources to aggregate to Category 2
quantity. These high-end Category 4 (\1/10\ of Category 3) sources are
possessed by the same licensees noted to have Category 3 sources,
namely those with fixed industrial gauges, those who conduct well-
logging operations, medical facilities with brachytherapy machines, and
a few radiographers, and as previously noted, are relatively widespread
in use and broadly used in industry, thus allowing for the potential
for aggregation of sufficient numbers of them to Category 2 levels. As
noted in this preamble for Category 3 sources, the Commission analyzed
additional costs and benefits of expanding the NSTS to \1/10\ of
Category 3 levels. As noted in the Regulatory Analysis, an expanded
NSTS to include \1/10\ of Category 3 sources would add approximately
2500 licensees with a resultant overall annual
[[Page 19753]]
cost to the industry and to the NRC that would be approximately doubled
again.
The Commission also considered including all of Category 4 sources
(and/or Category 5) in the NSTS, however in both cases it was decided
that, because of the magnitude of the thresholds of each of these
categories and the lower likelihood that sources at the lower range of
Category 4 or in Category 5 could be aggregated to the higher category
levels, that they would not be included in the expansion of the NSTS.
Based on these considerations of the nature of the sources at \1/
10\ of Category 3, their potential to aggregate to Category 2, and the
costs to the licensed industry and the NRC, the NRC has decided to also
include in the NSTS, sources below the Category 3 threshold, but
greater than or equal to a 10th of the Category 3 threshold. This is
consistent with the Code of Conduct which encourages countries to give
appropriate attention to radioactive sources considered to have the
potential to cause unacceptable consequences if employed for malicious
purposes and to aggregation of lower activity sources. The Commission
believes that the additional costs are reasonable to incur given the
additional improvement in accountability for these sources, given their
potential to be aggregated to more dangerous quantities. The Commission
believes that the existing NSTS can accommodate these additional
sources and that the NRC can expend the additional resources to monitor
these sources without detracting from the monitoring of Category 1 and
2 sources.
The NRC specifically invites comment on the inclusion of these
sources at \1/10\ of Category 3 in the NSTS. The staff is interested in
information concerning:
(1) The number of additional licensees that would be impacted;
(2) The number of sources between the Category 3 threshold and \1/
10\ of the Category 3 threshold that are possessed by licensees and the
activity levels of those sources relative to both of those values;
(3) How often these sources are involved in transactions
(manufacture, shipping, receipt, disposal, etc) and the nature of the
transaction process, including the ease of obtaining the sources and
the cost of the sources.
This information will enable the NRC to make a more informed
decision on the inclusion of sources greater than or equal to \1/10\ of
Category 3 in the NSTS.
B. Enhanced Accountability Provided by These Amendments
The NSTS, as currently planned for Category 1 and 2 sources, is a
web-based system that provides the NRC and Agreement States with
information related to transactions involving nationally tracked
sources. This information includes details of transfers of sources
between manufacturers and licensees, and disposal sites, for IAEA
Category 1 and 2 sources.
Expanding the NSTS to include additional nationally tracked sources
would use the same web-based system as for Category 1 and 2 sources,
namely providing the NRC with information regarding transactions
involving sufficient numbers of these additional sources that could be
aggregated into the equivalent of Category 2 source. By tracking
specific transactions involving these additional nationally tracked
sources, the NRC will be in a better position to track aggregation of
these sources and improve accountability for these sources. In
addition, with an expanded NSTS, NRC can be alert to discrepancies
between transaction reports of manufacturing and distribution licensees
and of the persons to whom the shipment of sources is being made. Also,
data from the NSTS could be used in conjunction with other data
management systems to provide for better source accountability.
C. Other Considerations
C.1 Other Alternative Approaches for Improving Accountability Require
Only Inventorying of Additional Categories of Sources
Another alternative approach considered for this rulemaking would
be to simply require licensees with sources greater than or equal to
either the Category 3 threshold or \1/10\ of the Category 3 threshold
to conduct and report inventories of nationally tracked sources.
However, this alternative would not provide the necessary near real-
time knowledge of source transactions and, in addition, lack of
transaction data from other licensees would not tend to lead to a
cross-check for accurate reporting of inventories. In addition, there
would still be significant costs incurred as a result of such a rule
including the costs of setting up an account in the NSTS (including
licensee credentialing); of conducting inventories; of marking serial
numbers; of inspections; of preparing Agreement State regulations; and
of NRC system monitoring, operation, and maintenance.
C.2 Potential Effects on the Existing NSTS for Category 1 and 2 Sources
An important consideration in the NRC's decision to propose
expansion of the NSTS is whether the expanded NSTS would divert
attention from, or otherwise compromise the currently planned NSTS. In
the SRM for SECY-06-0094, the Commission directed the staff to ensure
that the NSTS is capable of being modified to include Category 3
sources, and that an expanded NSTS does not divert attention or
resources from oversight of Category 1 and 2 sources.
This is an important consideration because activities to review new
data in the NSTS for the lower activity sources that would now be a
part of the NSTS should not divert NRC attention from reviewing and
monitoring licensee inventorying and tracking of the higher Category 1
and 2 which present a higher risk to human health. It is expected that
expansion of the NSTS will not compromise the information technology
(IT) aspects of the NSTS due to the capabilities incorporated into the
NSTS software. Because the IT design and software is flexible and
expandable, it can accommodate the anticipated number of licensees and
sources and the corresponding tracking activities under the proposed
expansion of the NSTS. Thus, it is anticipated that implementation of
the expanded NSTS can begin in the timeframe noted in Section II.D.7 of
the preamble. In addition, although it is recognized that additional
effort will be needed to monitor an expanded NSTS, NRC should be able
to continue to adequately monitor both the Category 1 and 2 sources in
the existing NSTS and the additional sources in the expanded NSTS and
identify possible concerns with aggregation of sources, if it uses the
appropriate additional resources which are discussed in the summary of
the Regulatory Analysis, Section XI.
C.3 Previous Comments Received Regarding Inclusion of Category 3
Sources in the NSTS During the Rulemaking To Establish the NSTS for
Category 1 and 2 Sources
Another consideration is the public comment received on the
proposed rule for establishing the NSTS for IAEA Category 1 and 2
sources. As noted in Section I of this preamble, the proposed
rulemaking the Commission issued specifically invited public comment.
The public comments received on this subject were discussed in the
November 6, 2006 final rule FRN establishing the NSTS.
The discussion in the final FRN noted that six commenters supported
inclusion of Category 3 while eighteen commenters opposed it. Reasons
given for supporting inclusion included that certain Category 3 sources
pose comparable threats to Category 2; that there was concern over
threats to
[[Page 19754]]
national security from potential aggregation of Category 3 sources;
that IAEA defines Category 3 sources as being dangerous and carrying a
potential risk of harm warranting inclusion in a tracking system; and
that these sources could be tracked with a modest additional
investment. These commenters noted that the inclusion of Category 3
sources should not disrupt implementation of the NSTS for Category 1
and 2 sources. Commenters opposing inclusion of Category 3 sources in
the NSTS generally cited the increased burden that would be imposed on
licensees and the NRC. Most of these commenters did not provide
specific numbers but indicated that inclusion of Category 3 sources
would cause a significant increase in the number of transaction reports
and unduly burden manufacturers and distributors. These commenters also
noted that many of the Category 3 sources are lower risk and do not
pose a significant threat compared to Category 1 and 2. These
commenters were concerned that inclusion of Category 3 sources would
bog down the NSTS and suggested that a better approach would be to
require inventory reporting rather than source transactions.
In response to all of these commenters, the Commission, in issuing
the final rule establishing the NSTS for Category 1 and 2 sources,
noted that it did not have adequate information at that point in time
to support inclusion of Category 3 sources in the NSTS. The Commission
also noted that it was working to develop additional information by
conducting a one-time survey of sources at a level of \1/10\ of
Category 3. The Commission then noted that, in that rulemaking, it was
not making a final determination on what additional sources should be
included in the NSTS and that if additional material is added to the
NSTS, it would be done through subsequent rulemaking, which is what the
Commission is currently conducting. In preparing this proposed rule,
the NRC has re-considered the relative concerns over accountability and
control of these sources; the relative risk the sources may present;
the potential for aggregation of lower activity sources to higher IAEA
Category levels; and the flexibility and expandability of the existing
NSTS to accommodate additional sources. Based on additional information
developed, the NRC has also prepared a detailed regulatory analysis of
the number of additional licensees and sources that would be included
in an expanded NSTS and the effect on licensees, the Agreement States
and the NRC. Based on its consideration of the comments and of the
results of the Regulatory Analysis, the Commission is proceeding with
the proposed rule for expansion of the NSTS.
D. General Content of the Proposed Rule
Based on the considerations of Sections II.A--II.C, NRC is
proposing to expand the NSTS by requiring licensees with additional
nationally tracked sources to report information to the NSTS on the
manufacture, transfer, receipt, disassembly, and disposal of nationally
tracked sources. The expanded NSTS would remain consistent with
recommendations in the IAEA Code of Conduct for development of a
national register of radioactive sources.
This section contains specific information on the content and
implementation of this expanded NSTS. The actions required of the
additional licensees with sources added to the NSTS are the same as
those for licensees currently within the scope of the NSTS. The
following discussion is based on supplementary information in the FRN
for the final rule establishing the NSTS for IAEA Category 1 and 2
sources (71 FR 65686, November 8, 2006). This section is intended to
provide licensees new to the NSTS, i.e., those with Category 3 sources
and sources greater than or equal to \1/10\ of Category 3, but less
than Category 2, with similar information as was provided in the FRN
for the final rule for the establishment of the NSTS for IAEA Category
1 and 2 sources.
D.1 Definition of a Nationally Tracked Source
A sealed source consists of radioactive material that is
permanently sealed in a capsule or closely bonded to a non-radioactive
substrate designed to prevent leakage or escape of the radioactive
material. In either case, it is effectively a solid form of radioactive
material which is not exempt from regulatory control. Under this
proposed rule, the definition of a nationally tracked source would be
revised to include sealed sources containing a quantity of radioactive
material equal to or greater than the \1/10\ of Category 3 levels
listed in the proposed amended Appendix E to 10 CFR Part 20. A
nationally tracked source may be either a Category 1 source, a Category
2 source, a Category 3 source or, a \1/10\ of Category 3 source. For
the purpose of this rulemaking, the term nationally tracked source does
not include material encapsulated solely for disposal, or nuclear
material contained in any fuel assembly, subassembly, fuel rod, or fuel
pellet. Material encapsulated solely for disposal refers to material
that without the disposal packaging would not be considered
encapsulated. For example, a licensee's bulk material that it plans to
send for burial may be placed in a matrix (e.g. mixed in concrete), to
meet burial requirements. The placement of the radioactive material in
the matrix material may be considered encapsulating. This type of
material would not be covered by the rule. However, if a nationally
tracked source were to be placed in a matrix material, the sealed
source would still be covered by the rule.
The specific radioactive material and activity levels covered by
this proposed rule are listed in the proposed revised Appendix E to 10
CFR Part 20. These activity values are \1/10\ of the Category 3 values
in Table 1 of the IAEA Code of Conduct. The Code of Conduct recommends
that at a minimum the radionuclides and the threshold values for
Category 1 and 2 should be included in a national source registry. The
U.S. Government has formally adopted these values to align domestic and
international efforts to increase the safety and security of certain
radioactive sources.
The Terabecquerel (TBq) values listed in Appendix E would be the
regulatory standard. The curie (Ci) values specified are obtained by
converting the TBq value. The Ci values are provided for reference only
and are rounded after conversion. The curie values are not intended to
be the regulatory standard.
D.2 Who Would be Affected by This Action
The proposed rule would apply to any person (entity or individual)
in possession of a Category 3 source or source greater than or equal to
\1/10\ of Category 3. It would apply to--
--Licensees with either NRC licenses or with Agreement State licenses;
--Manufacturers and distributors of Category 3 sources, and sources
greater than or equal to \1/10\ of Category 3;
--Medical facilities, radiographers, well-loggers, licensees using
fixed gauges, and any other licensees that are the end users of
nationally tracked sources;
--Disposal facilities and waste brokers; and
--Owners of a source that is not actively used or in long-term storage.
Nationally tracked sources (as the definition would be expanded by
this proposed rule) include sources
[[Page 19755]]
possessed by various types of licensees, but primarily by byproduct
material licensees, and are used in the oil and gas, electrical power,
construction, medical, food industries, and in technology research and
development. The definition of nationally tracked sources would be
modified by this rulemaking to include Category 3 and sources greater
than or equal to \1/10\ of Category 3 based on the activity level of
the radioactive material. Category 3 sources or sources greater than or
equal to \1/10\ of Category 3 are typically used in devices such as
medical brachytherapy units, well-logging, fixed gauges used throughout
various industries, and radiography units in which the radioactivity
has decreased from higher IAEA Category 2 levels due to radioactive
decay.
D.3 How Information Would Be Reported to the NSTS
Licensees have several methods for providing the required
information under the existing NSTS (see Section II.D.4 of this
preamble for the specific information that would be reported to the
NSTS). Under the proposed expanded NSTS, these methods would continue
to include on-line, computer-readable format files, paper, fax, and
telephone and are described below:
--Reporting information on-line: For most licensees, the most
convenient, least burdensome method will be to report the information
on-line. In this method, licensees can log on to the system and enter
the required information by filling out a form on-line. To report
information on-line, a licensee would need to establish an account with
the NSTS. Once an account is established, the licensee would be
provided with password information that would allow access to the on-
line system. A licensee would have access only to information regarding
its own material or facility; a licensee would not have access to
information concerning other licensees or facilities. When logged on,
the licensee could type the necessary information onto the on-line
forms. Once a source is in the system, the licensee would be able to
click on the source and report a transfer or other transaction. The
identifying information would not need to be typed in a second time
because information such as license number, facility name, and address
would pop up automatically.
--Computer-readable format: Many licensees conduct a large number of
transactions, especially manufacturing and distribution licensees. We
recognize that most licensees have a system in which information on
sources is maintained. The NSTS will be able to accept batch load
information using a computer-readable format. This should ease the
reporting burden for a licensee with a large number of transactions.
The licensee would be able to electronically send a batch load using a
computer readable format file that contained all of the transactions
that occurred that day. The format could also be used for reporting the
initial inventory. NRC and the entity responsible for developing the
NSTS will work with licensees to develop the mechanism to accept batch
load information so that it is compatible with many of the existing
systems in use by licensees.
--Paper submittals by mail, fax, or telephone: Licensees would also be
able to complete a paper version of the National Source Tracking
Transaction form and submit the form by either mail or fax. Licensees
would also be able to provide transaction information by telephone and
then follow-up with a paper copy.
D.4 Specific Information That Licensee Would Report Under the Expanded
NSTS
Under the requirements of the NSTS, the additional licensees
covered by the NSTS would be required to conduct the following actions:
--Report their initial inventory of sources greater than or equal to
\1/10\ of Category 3 nationally tracked sources to NSTS;
--On an annual basis, reconcile and verify the inventory of sources
greater than or equal to \1/10\ of Category 3 possessed against the
data in the NSTS;
--Complete and submit a National Source Tracking Transaction Report
(i.e., NRC Form 748) after each transaction involving a Category 3 or a
\1/10\ of Category 3 source;
--Correct any errors in previously filed National Source Tracking
Transaction Reports within five business days of the discovery; and
--For licensees who manufacture a Category 3 or \1/10\ of Category 3
nationally tracked source, assign a unique serial number to each
source.
How licensees would carry out these requirements is discussed in
more detail in the following subsections.
D.4.1 Reporting Initial (Current) Inventory to the NSTS
As noted, licensees would be required to report their initial
(i.e., current) inventory of nationally tracked sources by a specified
date. Licensees would be required to report all sources greater than or
equal to \1/10\ of Category 3 to the NSTS by July 31, 2009.
To ease the implementation of the reporting process, information
already in NRC's One-Time Data Collection would be downloaded to the
NSTS. A licensee whose nationally tracked source information was
reported to the One-Time Data Collection database would be provided a
copy of its information and would need only to either verify the
information or provide updated information. NRC staff and the entity
that operates the NSTS will work with licensees to make sure the
inventory information is correct. A licensee whose information was not
reported to the One-Time Data Collection database would need to report
the information on its nationally tracked source inventory by specified
date above. Disposal facilities would not need to report sources that
have already been buried or otherwise disposed.
D.4.2 Annual Reconciliation and Verification of Information in the NSTS
Licensees would be required to reconcile their on-site inventory of
nationally tracked sources with the information previously reported to
the NSTS. This reconciliation would occur during the month of January
of each year. This reconciliation would be necessary to maintain the
accuracy and reliability of the National Source Tracking database. The
licensee would be able to print a copy of the inventory information
from the NSTS. Licensees without on-line access would receive a paper
copy of the information in the NSTS. The licensee would compare the
information in the system to the actual inventory at the licensee's
facility, including a check of the model and serial number of each
source. This reconciliation would not require the licensee to conduct
an additional physical inventory of its sources. Under current
regulations, licensees are currently required to conduct physical
inventories annually, semi-annually, or quarterly depending on the type
of license. The licensee would be required to reconcile any differences
by reporting the appropriate transaction(s) or corrections to the NSTS.
The licensee would be required to verify by the end of January of each
year that the inventory in the NSTS is correct. The first
reconciliation would occur in January 2010.
[[Page 19756]]
D.4.3 Reporting Transaction Information to the NSTS
Prompt updating of the NSTS is necessary for it to be useful and
accurate. In order to capture information as soon as possible,
licensees would be required to report information on nationally tracked
source transactions by the close of the next business day after the
transaction. To ease the burden on licensees, any of the methods for
reporting the information listed in Section E.3 may be used. Specific
transaction information that would be required is discussed in the
following subsections.
D.4.3.1 Reporting Information on Source Manufacture
Sources Manufactured in the United States: When a nationally
tracked source is manufactured in the United States, the source
manufacturer licensee would be required to report the source
information to the NSTS. The information must be reported by the close
of the next business day after manufacture and includes: Manufacturer
(make), model number, serial number, radioactive material, activity at
manufacture, and manufacture date for each source. The licensee must
also provide its license number, facility name, as well as the name of
the individual that prepared the report.
Recycled, Reconfigured, and Disassembled Sources: Some sources are
recycled, reconfigured, or disassembled. For example, a source that has
decayed below its usefulness may be returned to the manufacturer for
reconfiguration or disassembly. The decayed source may be placed in a
reactor and reactivated, or placed in storage. The source retains its
serial number, but now has a new activity. The new activity and
creation date of the source must be reported to the NSTS.
Imported Sources: For every nationally tracked source that is
imported, the facility obtaining the source would be required to report
the information on the manufacture of the source to the NSTS by the
close of the next business day after receipt of the imported source at
the site. For the purposes of the NSTS, this would be considered the
source origin unless the source had been previously possessed in the
United States. The licensee would need to report the manufacturer
(make), model number, serial number, radioactive material, activity at
manufacture or import, and manufacture or import date for each source.
The licensee must also provide its license number, facility name,
address, as well as the name of the individual that prepared the report
and the date of receipt. The licensee would also need to provide
information on the facility (name and address) that sent the source and
the import license number if applicable. Note: Only Category 1 and
Category 2 sources including multiple sources that aggregate to at
least a Category 2 level on a per shipment basis, require a specific
NRC import license.
The NRC is interested in determining whether specific requirements
for tracking should also be included in 10 CFR Part 110 and
specifically invites comment on this question.
D.4.3.2 Reporting Information on Source Transfer
Transfers between licensees: Each time a nationally tracked source
is transferred to another facility authorized to use or possess the
source, the licensee would be required to report the transfer to the
NSTS by the close of the next business day. The licensee must report
the recipient name (facility the source is being transferred to),
address, license number, the shipping date, the estimated arrival date,
and the identifying source information (manufacturer, model number,
serial number, and radioactive material). The licensee also would need
to provide its name, address, and license number, as well as the name
of the individual making the report. For nationally tracked sources
that are transferred as waste under a Uniform Low-level Radioactive
Waste Manifest, the licensee would also have to report the waste
manifest number and the container identification number for the
container with the nationally tracked source.
Transfers where the source stays within the licensee's possession:
Source transfer transactions only cover transfers between different
licensees and/or authorized facilities. They do not include transfer to
a temporary job site. Transactions in which the nationally tracked
source remains in the possession of the licensee would not require a
report to the NSTS. For example, a radiographer conducting business
would not need to report transfers between temporary job sites, even if
the temporary job site is located in another state or if the work is
conducted under a reciprocity agreement.
Export of sources: Export of sources would be treated as a
transfer. An export is considered a reversible endpoint (e.g., a place
of use or storage that is not a temporary job site) because the source
can be imported back into the country. The export license number would
be reported as the license number of the receiving facility. Note: Only
Category 1 and 2 sources, including multiple sources that aggregate to
at least a Category 2 level on a per shipment basis, are required to
have a specific NRC export license. Most Category 3 and below sources
can be exported under a general license in accordance with 10 CFR
110.23.
D.4.3.3 Reporting Information for Receipt of Sources
Receipt of sources: A licensee would be required to report each
receipt of a nationally tracked source by the close of the next
business day. The licensee must report the identifying source
information (manufacturer, model number, serial number, and radioactive
material) and the date of receipt. The licensee also must include its
facility name and license number and the name of the individual that
prepared the report. In addition, the licensee must provide the name
and license number of the facility that sent the source because this
information is necessary to match the transactions.
Receipt of imported sources: If the source received is an import,
the licensee would also need to report the source activity and
associated activity date. The import license number would be reported
as the license number of the sending facility.
Receipt of sources in a waste shipment: If a licensee receives a
nationally tracked source as part of a waste shipment, the licensee
must provide the Uniform Low-level Radioactive Waste Manifest number
and the container identification for the container that contains the
nationally tracked source. A waste broker or disposal facility are
examples of licensees that might receive a nationally tracked source as
part of a waste shipment. These licensees would not be expected to open
the waste container and verify the presence of the nationally tracked
source; they may rely on the information from the licensee who shipped
the source.
D.4.3.4 Reporting Information on Source Disposal
Licensees sending a source for disposal: Licensees sending a source
to a low-level burial ground for disposal would treat the transaction
as a transfer (see Section II.D.4.3.2), and would report the types of
information to be reported for a transfer, along with the waste
manifest number and the container identification number.
Disposal facilities: Disposal of a source would be reported by the
[[Page 19757]]
licensee conducting the actual burial in a low-level disposal facility
or other authorized disposal mechanism. The disposal facility may rely
on the information from the licensee that sent the waste for disposal
and is not expected to open the waste container to verify contents. The
disposal facility must report to the NSTS the date and method of
disposal, the waste manifest number, and the container identification
number for the container with the nationally tracked source. The
disposal facility must also provide its facility name and license
number, as well as the name of the individual that prepared the report.
The report must be made by the close of the next business day.
D.4.3.5 Information Regarding Reporting (or Not Reporting) of Other
Source Endpoints
Decay of sources: One feature of the NSTS would be that the decay
of a source would be automatically calculated so a licensee would not
need to report an endpoint of decay. Once a source has decayed below
\1/10\ of Category 3 threshold level, it would no longer be considered
a nationally tracked source, and the source would automatically be
removed from a licensee's active inventory in the NSTS. The licensee
would receive a notification that the source has decayed below the
tracking level, and that transactions for this source no longer need to
be reported. The data on the source, however, will be retained in the
system.
Accidental destruction of sources: Licensees currently report
accidental destruction of sources to the NRC Operations Center or to
the Agreement States. NRC staff would enter the information from the
event report into the NSTS. Because sealed sources are designed to be
robust, accidental destruction should be and is rare.
Lost or stolen sources or source abandoned in a well: These
endpoints would be captured by the NSTS. These events are already
reported to either NRC or to the Agreement States. Licensees would not
be required to report this information a second time to the NSTS.
Agreement State licensees would continue to report to the Agreement
State. NRC staff would obtain the information on these events from the
event reports or the Nuclear Medical Event Database and enter the
information into the NSTS.
D.4.4 Reporting Errors in Transaction Reports
Data integrity for the NSTS is extremely important and necessary to
keep the information correct and up-to-date. Licensees are expected to
provide correct information to the NSTS and to double-check the
accuracy of information before submission.
However, the NRC recognizes that some transactions may be missed
and that errors may creep into the system over time. Typical reasons
for discrepancies could be failure to report the receipt of a source,
failure to report the transfer of a source to another licensee, finding
a source that was missed during the reporting of the initial inventory,
selection of the wrong model number, or incorrect typing of the serial
number.
Each licensee would be required to correct any errors or missed
transactions that it discovers, and to correct any of their inaccurate
information in the NSTS, regardless of the origin of the error, within
5 business days of the discovery. Typing errors and errors such as
inadvertent selection of the wrong model number need to be corrected in
the system so that the information in the NSTS is correct. A licensee
would be able to submit a corrected form that contains the correct
information online or through any other permitted reporting mechanism
at any time.
D.4.5 For Manufacturers, Assigning a Unique Serial Number to Sources
The proposed rule would require manufacturers of nationally tracked
sources to use a unique serial number for each source. The combination
of manufacturer, model, and serial number will be used in the NSTS to
track the history of each source.
D.5 Access to the Information in the NSTS and What Would It be Used For
Information in the NSTS will be considered Official Use Only. This
means that the information is to be protected and not disclosed to the
general public. A licensee would be able to view its own data, but not
data for other licensees. Agreement State staff would be able to view
information on the licensees in their State, but would not be able to
view information on licensees in other States. The one exception is
information related to lost or stolen sources. Agreement State staff
would be able to view the information on lost or stolen sources from
all licensees. This will enable better coordination of recovery
efforts. Other Federal and State agencies would also be able to view
the information on lost or stolen sources and other information on a
need-to-know basis.
Once fully operational, the expanded NSTS would be used for a
variety of purposes. This standardized, centralized information will
help NRC and Agreement States to monitor the location and use of
nationally tracked sources; conduct inspections and investigations;
communicate nationally tracked source information to other government
agencies; verify legitimate ownership and use of nationally tracked
sources; and further analyze hazards attributable to the possession and
use of these sources.
D.6 Implementation and Enforcement of the Expanded NSTS
Implementation and enforcement activities, whether the licensee
population includes those possessing Category 1 and 2 sources only, or
those possessing Category 3 sources or sources greater than or equal to
\1/10\ of Category 3, would be of a similar nature. The NSTS rule
reporting requirements include reporting by licensees of an initial
inventory, an annual reconciliation of source inventory, and source
transactions. The implementation process would include specific actions
to make the affected licensee population aware of the amended
requirements in 10 CFR parts 20 and 32 through outreach with licensee
groups/organizations, and information on the NRC Web site. In addition,
at this time, guidance is in preparation for implementation of the NSTS
for Category 1 and 2 licensees; similar guidance will be developed for
Category 3 sources and sources greater than or equal to \1/10\ of
Category 3 licensees. Regarding enforcement action, in a manner similar
to that for Category 1 and 2 licensees, NRC and the Agreement states
would first need to identify licensees who had not reported the
required inventory and transaction information, based on knowledge of
the licensee population of interest, which would be determined by using
the Licensee Tracking System and eventually by the Web Based Licensing
(WBL), when operational.
D.7 When These Actions Become Effective
The rule would become effective 60 days after the final rule is
published in the Federal Register. The requirements for sources greater
than or equal to \1/10\ of Category 3 nationally tracked sources would
be implemented by July 31, 2009. This means that by this date any
licensee that possesses a Category 3 or sources greater than or equal
to \1/10\ of Category 3 must have reported its initial inventory and
report thereafter all transactions involving sources greater than or
equal to \1/10\ of Category 3 to the NSTS.
[[Page 19758]]
III. Discussion of Proposed Amendments by Section
Section 20.1003 Definitions
An expanded definition of nationally tracked sources to include
Category 3 and \1/10\ of Category 3 sources would be added to the
regulations.
Section 20.2207 Reports of Transactions Involving Nationally Tracked
Sources
A revision to paragraph (h) would require a licensee to report its
initial inventory of Category 3 and \1/10\ of Category 3 nationally
tracked sources by July 31, 2009.
Appendix E Nationally Tracked Source Thresholds
A revision to Appendix E of 10 CFR Part 20 would be made to revise
the thresholds for nationally tracked sources to include Category 3 and
\1/10\ of Category 3 levels. The Terabecquerel (TBq) values listed in
the revised Appendix E are the regulatory standard. The curie (Ci)
values specified are obtained by converting from the TBq value. The Ci
values are provided for reference only and are rounded after
conversion. The curie values are not intended to be the regulatory
standard.
Section 32.2 Definitions
An expanded definition of nationally tracked sources to include
Category 3 and \1/10\ of Category 3 sources would be added to the
regulations.
IV. Criminal Penalties
For the purpose of Section 223 of the Atomic Energy Act (AEA), as
amended, the Commission is proposing to amend 10 CFR Parts 20 and 32
under one or more of Sections 161b, 161i, or 161o of the AEA. Willful
violations of the rule would be subject to criminal enforcement.
V. Agreement State Compatibility
Under the ``Policy Statement on Adequacy and Compatibility of
Agreement State Programs'' approved by the Commission on June 30, 1997,
and published in the Federal Register on September 3, 1997 (62 FR
46517), Sec. 20.2207 of the proposed rule is classified as
Compatibility Category ``B.'' The NRC program elements in this category
are those that apply to activities that have direct and significant
transboundary implications. An Agreement State should adopt program
elements essentially identical to those of NRC. Agreement State and NRC
licensees would report their transactions to the NSTS and the database
will be maintained by the NRC.
VI. Plain Language
The Presidential Memorandum ``Plain Language in Government
Writing'' published June 10, 1998 (63 FR 31883), directed that the
Government's documents be in clear and accessible language. The NRC
requests comments on this proposed rule specifically with respect to
the clarity and effectiveness of the language used. Comments should be
sent to the address listed under the ADDRESSES heading.
VII. Voluntary Consensus Standards
The National Technology Transfer Act of 1995 (Pub. L. 104-113)
requires that Federal agencies use technical standards that are
developed or adopted by voluntary consensus standards bodies unless the
use of such a standard is inconsistent with applicable law or otherwise
impractical. In this proposed rule, the NRC would require licensees
that possess, manufacture, transfer, receive, or dispose of the
nationally tracked sources specified in the proposed rule to report the
information relating to such transactions to the National Source
Tracking System. This action does not constitute the establishment of a
standard that contains generally applicable requirements.
VIII. Environmental Impact: Categorical Exclusion
The NRC has determined that this proposed rule is the type of
action described as a categorical exclusion in 10 CFR 51.22(c)(3)(iii).
Therefore, neither an environmental impact statement nor an
environmental assessment has been prepared for this proposed rule.
IX. Paperwork Reduction Act Statement
This proposed rule contains new or amended information collection
requirements that are subject to the Paperwork Reduction Act of 1995
(44 U.S.C. 3501 et seq.). This rule has been submitted to the Office of
Management and Budget (OMB) for review and approval of the information
collection requirements.
Type of submission, new or revision: Revision.
The title of the information collection: 10 CFR Parts 20 and 32,
National Source Tracking of Sealed Sources.
The form number, if applicable: NRC Form 748.
How often the collection is required: Initially, at completion of a
transaction, and at inventory reconciliation annually.
Who will be required or asked to report: Licensees that
manufacture, receive, disassemble, transfer, or dispose of nationally
tracked sources.
An estimate of the number of annual responses: 20,912 (19,746
responses and 1,166 recordkeepers).
The estimated number of annual respondents: 3500 (NRC 700;
Agreement States 2800).
An estimate of the total number of hours needed annually to
complete the requirement or request: The total burden increase for this
rulemaking is 16,821 hours (10 CFR Part 20: 13,748 hours; 10 CFR Part
32: 600 hours; NRC Form 748: 2,473 hours).
Abstract: The NRC is proposing to amend its regulations to expand
the NSTS to include Category 3 and \1/10\ of Category 3 sealed sources.
The proposed amendments would require licensees to report certain
transactions involving nationally tracked sources to the NSTS. These
transactions would include manufacture, transfer, disassembly, receipt,
or disposal of the nationally tracked source. The proposed amendment
would require each licensee to provide its initial inventory of
nationally tracked sources to the NSTS and to annually verify and
reconcile the information in the system with the licensee's actual
inventory. The proposed rule would also require manufacturers of
nationally tracked sources to assign a unique serial number of each
source. This information collection is mandatory and will be used to
populate the NSTS.
The NRC is seeking public comment on the potential impact of the
information collections contained in this proposed rule and on the
following issues:
1. Is the proposed information collection necessary for the proper
performance of the functions of the NRC, including whether the
information will have practical utility?
2. Is the estimate of burden accurate?
3. Is there a way to enhance the quality, utility, and clarity of
the information to be collected?
4. How can the burden of the information collection be minimized,
including the use of automated collection techniques?
A copy of the OMB clearance package may be viewed free of charge at
the NRC Public Document Room, One White Flint North, 11555 Rockville
Pike, Room O-1 F21, Rockville, MD 20852. The OMB clearance package and
rule are available at the NRC Worldwide Web site: http://www.nrc.gov/public-involve/doc-comment/omb/index.html for 60 days after the
signature date of this notice.
Send comments on any aspect of these proposed information
collections,
[[Page 19759]]
including suggestions for reducing the burden and on the above issues,
by May 12, 2008 to the Records and FOIA/Privacy Services Branch (T-5
F52), U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, or
by Internet electronic mail to [email protected] and to the Desk
Officer, Nathan Frey, Office of Information and Regulatory Affairs,
NEOB-10202 (3150-0001, 3150-0014, 3150-0202), Office of Management and
Budget, Washington, DC 20503. Comments on the proposed information
collections may also be submitted via the Federal eRulemaking Portal
http://www.regulations.gov, docket NRC-2008-0200. Comments
received after this date will be considered if it is practical to do
so, but assurance of consideration cannot be given to comments received
after this date. You may also comment by telephone at (202) 395-7345.
X. 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.
XI. Regulatory Analysis
The Commission has prepared a draft regulatory analysis on this
proposed regulation. The analysis examines the costs and benefits of
the alternatives considered by the Commission.
The Regulatory Analysis considers costs to licensees that would
result from the proposed amendments. The largest burden would likely
fall on the manufacturers and distributors of nationally tracked
sources because they will have the most transactions to report. The NRC
believes that by allowing batch loading of information using a computer
readable format, the burden on the high transaction licensees will be
lessened. The Regulatory Analysis also considers costs to the NRC and
to Agreement States, including initial costs of entering licensees into
the NSTS, annual costs of maintenance and operation of the expanded
NSTS, costs of inspections, and costs to Agreement States of issuing
legally binding requirements.
The Commission requests public comment on the draft regulatory
analysis. Comments may be submitted to the NRC as indicated under the
ADDRESSES heading. The analysis is available for inspection in the NRC
Public Document Room (Adams Accession Number ML080910314), 11555
Rockville Pike, Rockville, MD 20852. Single copies of the draft
regulatory analysis are available from Michael Williamson, telephone
(301) 415-6284, e-mail [email protected], of the Office of Federal and State
Materials and Environmental Management Programs.
XII. Regulatory Flexibility Certification
In accordance with the Regulatory Flexibility Act of 1980 (5 U.S.C.
605(b)), the Commission certifies that this rule would not, if
promulgated, have a significant economic impact on a substantial number
of small entities. The proposed rule would affect about 700 NRC
licensees and an additional 2800 Agreement State licensees possessing
Category 3 and \1/10\ of Category 3 sources. Affected licensees include
laboratories, reactors, universities, colleges, medical clinics,
hospitals, irradiators, and radiographers, some of which may qualify as
small business entities as defined by 10 CFR 2.810. However, the
proposed rule is not expected to have a significant economic impact on
these licensees.
The total time required by a licensee to complete each National
Source Tracking Transaction report depends on the number of sources
involved in the transaction and the method of reporting. No research or
compilation is necessary as all information is transcribed from bills
of lading, in-house records kept for other purposes, sales agreements,
etc. Each licensee would also spend time on an annual reconciliation of
their inventory with the NSTS. As discussed in Section XI of this
preamble, the draft regulatory analysis conducted for this action
estimates the one-time and annual costs of the proposed amendments for
affected licensees based on estimated burdens for actions to comply
with the proposed amendments. The NRC believes that the selected
alternative reflected in the proposed amendment is the least
burdensome, most flexible alternative that would accomplish the NRC's
regulatory objective.
Because of the widely differing conditions under which impacted
licensees operate, the NRC is specifically requesting public comment
from licensees concerning the impact of the proposed regulation. The
NRC particularly desires comment from licensees who qualify as small
businesses, specifically as to how the proposed regulation will affect
them and how the regulation may be tiered or otherwise modified to
impose less stringent requirements on small entities while still
adequately protecting the public health and safety. Comments on how the
regulation could be modified to take into account the differing needs
of small entities should specifically discuss:
(1) The size of the business and how the proposed regulation would
result in a significant economic burden upon it as compared to a larger
organization in the same business community;
(2) How the proposed regulation could be further modified to take
into account the business's differing needs or capabilities;
(3) The benefits that would accrue, or the detriments that would be
avoided, if the proposed regulation was modified as suggested by the
commenter;
(4) How the proposed regulation, as modified, would more closely
equalize the impact of NRC regulations as opposed to providing special
advantages to any individuals or groups; and
(5) How the proposed regulation, as modified, would still
adequately protect the public health and safety.
Comments should be submitted as indicated under the ADDRESSES
heading.
XIII. Backfit Analysis
The NRC has determined that the backfit rule (Sec. Sec. 50.109,
70.76, 72.62, or 76.76) does not apply to this proposed rule because
this amendment would not involve any provisions that would impose
backfits as defined in the backfit rule. Therefore, a backfit analysis
is not required.
List of Subjects
10 CFR Part 20
Byproduct material, Criminal penalties, Licensed material, Nuclear
materials, Nuclear power plants and reactors, Occupational safety and
health, Packaging and containers, Radiation protection, Reporting and
recordkeeping requirements, Source material, Special nuclear material,
Waste treatment and disposal.
10 CFR Part 32
Byproduct material, Criminal penalties, Labeling, Nuclear
materials, Radiation protection, Reporting and recordkeeping
requirements.
For the reasons set out in the preamble and under the authority of
the Atomic Energy Act of 1954, as amended; the Energy Reorganization
Act of 1974, as amended; and 5 U.S.C. 553; the NRC is proposing to
adopt the following amendments to 10 CFR Parts 20 and 32.
PART 20--STANDARDS FOR PROTECTION AGAINST RADIATION
1. The authority citation for Part 20 continues to read as follows:
Authority: Secs. 53, 63, 65, 81, 103, 104, 161, 182, 186, 68
Stat. 930, 933, 935, 936,
[[Page 19760]]
937, 948, 953, 955, as amended, sec. 1701, 106 Stat. 2951, 2952,
2953 (42 U.S.C. 2073, 2093, 2095, 2111, 2133, 2134, 2201, 2232,
2236, 2297f), secs. 201, as amended, 202, 206, 88 Stat. 1242, as
amended, 1244, 1246 (42 U.S.C. 5841, 5842, 5846); sec. 1704, 112
Stat. 2750 (44 U.S.C. 3504 note); Sec. 651(e), Pub. L. 109-58, 119
Stat. 806--810 (42 U.S.C. 2014, 2021, 2021b, 2111).
2. In Sec. 20.1003, the definition nationally tracked source is
revised to read as follows:
Sec. 20.1003 Definitions.
* * * * *
Nationally tracked source is a sealed source containing a quantity
equal to or greater than Category 1, Category 2, Category 3, or \1/10\
of Category 3 levels of any radioactive material listed in Appendix E
of this Part. In this context a sealed source is defined as radioactive
material that is sealed in a capsule or closely bonded, in a solid form
and which is not exempt from regulatory control. It does not mean
material encapsulated solely for disposal, or nuclear material
contained in any fuel assembly, subassembly, fuel rod, or fuel pellet.
Category 1 nationally tracked sources are those containing radioactive
material at a quantity equal to or greater than the Category 1
threshold. Category 2 nationally tracked sources are those containing
radioactive material at a quantity equal to or greater than the
Category 2 threshold but less than the Category 1 threshold. Category 3
nationally tracked sources are those containing radioactive material at
a quantity equal to or greater than the Category 3 threshold but less
than the Category 2 threshold. The \1/10\ of Category 3 nationally
tracked sources are those containing radioactive material at a quantity
greater than or equal to \1/10\ of Category 3 threshold but less than
the Category 3 threshold.
* * * * *
3. In Sec. 20.2207, paragraph (h) is revised to read as follows:
Sec. 20.2207 Reports of transactions involving nationally tracked
sources.
* * * * *
(h) Each licensee that possesses Category 1 nationally tracked
sources shall report its initial inventory of Category 1 nationally
tracked sources to the National Source Tracking System by January 31,
2009. Each licensee that possesses Category 2 nationally tracked
sources shall report its initial inventory of Category 2 nationally
tracked sources to the National Source Tracking System by January 31,
2009. Each licensee that possesses Category 3 or \1/10\ of Category 3
nationally tracked sources shall report its initial inventory of
Category 3 or \1/10\ of Category 3 nationally tracked sources to the
National Source Tracking System by July 31, 2009. The information may
be submitted by using any of the methods identified by paragraphs
(f)(1) through (f)(4) of this section. The initial inventory report
must include the following information:
(1) The name, address, and license number of the reporting
licensee;
(2) The name of the individual preparing the report;
(3) The manufacturer, model, and serial number of each nationally
tracked source or, if not available, other information to uniquely
identify the source;
(4) The radioactive material in the sealed source;
(5) The initial or current source strength in becquerels (curies);
and
(6) The date for which the source strength is reported.
4. In Part 20, Appendix E is revised to read as follows:
Appendix E to Part 20--Nationally Tracked Source Thresholds
The Terabecquerel (TBq) values are the regulatory standard as
promulgated by the International Atomic Energy Agency for Categories
1-3 of its Code of Conduct on the Safety and Security of Radioactive
Sources, published in January 2004. The curie (Ci) values specified
are obtained by converting the TBq value. The curie values are
provided for practical usefulness only.
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1/10\ of \1/10\ of
Radioactive material Category 1 Category 1 Category 2 Category 2 Category 3 Category 3 Category 3 Category 3
(TBq) (Ci) (TBq) (Ci) (TBq) (Ci) (TBq) (Ci)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Actinium-227...................................... 20 540 0.2 5.4 .02 0.54 0.002 0.054
Americium-241..................................... 60 1,600 0.6 16 0.06 1.6 0.006 0.16
Americium-241/Be.................................. 60 1,600 0.6 16 0.06 1.6 0.006 0.16
Californium-252................................... 20 540 0.2 5.4 0.02 0.54 0.002 0.054
Cobalt-60......................................... 30 810 0.3 8.1 0.03 0.81 0.003 0.081
Curium-244........................................ 50 1,400 0.5 14 0.05 1.4 0.005 0.14
Cesium-137........................................ 100 2,700 1 27 0.01 2.7 0.001 0.27
Gadolinium-153.................................... 1,000 27,000 10 270 1 27 0.1 2.7
Iridium-192....................................... 80 2,200 0.8 22 0.08 2.2 0.008 0.22
Plutonium-238..................................... 60 1,600 0.6 16 0.06 1.6 0.006 0.16
Plutonium-239/Be.................................. 60 1,600 0.6 16 0.06 1.6 0.006 0.16
Polonium-210...................................... 60 1,600 0.6 16 0.06 1.6 0.006 0.16
Promethium-147.................................... 40,000 1,100,000 400 11,000 40 1100 4 110
Radium-226........................................ 40 1,100 0.4 11 0.04 1.1 0.004 0.11
Selenium-75....................................... 200 5,400 2 54 0.02 5.4 0.002 0.54
Strontium-90...................................... 1,000 27,000 10 270 1 27 0.10 2.7
Thorium-228....................................... 20 540 0.2 5.4 0.02 0.54 0.002 0.054
Thorium-229....................................... 20 540 0.2 5.4 0.02 0.54 0.002 0.054
Thulium-170....................................... 20,000 540,000 200 5,400 20 540 2 54
Ytterbium-169..................................... 300 8,100 3 81 0.03 8.1 0.003 0.81
--------------------------------------------------------------------------------------------------------------------------------------------------------
PART 32--SPECIFIC DOMESTIC LICENSES TO MANUFACTURE OR TRANSFER
CERTAIN ITEMS CONTAINING BYPRODUCT MATERIAL
5. The authority citation for Part 32 continues to read as follows:
Authority: Secs. 81, 161, 182, 183, 68 Stat. 935, 948, 953, 954,
as amended (42 U.S.C. 2111, 2201, 2232, 2233); sec. 201, 88 Stat.
1242, as amended (42 U.S.C. 5841); sec. 1704, 112 Stat. 2750 (44
U.S.C. 3504 note); sec. 651(e), Pub. L. 109-58, 119 Stat. 806-810
(42 U.S.C. 2014, 2021, 2021b, 2111).
6. In Sec. 32.2, the definition nationally tracked source is
revised to read as follows:
Sec. 32.2 Definitions.
* * * * *
Nationally tracked source is a sealed source containing a quantity
equal to or greater than Category 1, 2, 3, or \1/10\ of Category 3
levels of any radioactive material listed in Appendix E to 10 CFR Part
20. In this context a sealed source
[[Page 19761]]
is defined as radioactive material that is permanently sealed in a
capsule or closely bonded, in a solid form and which is not exempt from
regulatory control. It does not mean material encapsulated solely for
disposal, or nuclear material contained in any fuel assembly,
subassembly, fuel rod, or fuel pellet.
Category 1 nationally tracked sources are those containing
radioactive material at a quantity equal to or greater than the
Category 1 threshold. Category 2 nationally tracked sources are those
containing radioactive material at a quantity equal to or greater than
the Category 2 threshold but less than the Category 1 threshold.
Category 3 nationally tracked sources are those containing radioactive
material at a quantity equal to or greater than the Category 3
threshold but less than the Category 2 threshold. Category \1/10\ of
Category 3 nationally tracked sources are those containing radioactive
material at a quantity equal to or greater than the \1/10\ of Category
3 threshold but less than the Category 3 threshold.
Dated at Rockville, Maryland, this 7th day of April 2008.
For the U.S. Nuclear Regulatory Commission.
Annette L. Vietti-Cook,
Secretary of the Commission.
[FR Doc. E8-7756 Filed 4-10-08; 8:45 am]
BILLING CODE 7590-01-P