Expansion of the National Source Tracking System, 19749-19761 [E8-7756]
Download as PDF
19749
Proposed Rules
Federal Register
Vol. 73, No. 71
Friday, April 11, 2008
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.
NUCLEAR REGULATORY
COMMISSION
10 CFR Parts 20 and 32
RIN 3150–AI29
[NRC–2008–0200]
Expansion of the National Source
Tracking System
Nuclear Regulatory
Commission.
ACTION: Proposed rule.
AGENCY:
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.
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).
ebenthall on PRODPC61 with PROPOSALS
ADDRESSES:
VerDate Aug<31>2005
15:24 Apr 10, 2008
Jkt 214001
Personal information, such as your
name, address, telephone number, email 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:
Rulemaking.Comments@nrc.gov. 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 https://
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
https://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 pdr@nrc.gov.
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, mkw1@nrc.gov.
SUPPLEMENTARY INFORMATION:
I. Background
II. Discussion
PO 00000
Frm 00001
Fmt 4702
Sfmt 4702
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
E:\FR\FM\11APP1.SGM
11APP1
ebenthall on PRODPC61 with PROPOSALS
19750
Federal Register / Vol. 73, No. 71 / Friday, April 11, 2008 / Proposed Rules
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 radionuclidespecific 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
VerDate Aug<31>2005
15:24 Apr 10, 2008
Jkt 214001
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
PO 00000
Frm 00002
Fmt 4702
Sfmt 4702
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).
E:\FR\FM\11APP1.SGM
11APP1
Federal Register / Vol. 73, No. 71 / Friday, April 11, 2008 / Proposed Rules
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 SubGroups of Categories) of Sources To Be
Included
ebenthall on PRODPC61 with PROPOSALS
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:
1 RS–G–1.9 ‘‘Categorization of Radioactive
Sources.’’
VerDate Aug<31>2005
15:24 Apr 10, 2008
Jkt 214001
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,
PO 00000
Frm 00003
Fmt 4702
Sfmt 4702
19751
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:
E:\FR\FM\11APP1.SGM
11APP1
ebenthall on PRODPC61 with PROPOSALS
19752
Federal Register / Vol. 73, No. 71 / Friday, April 11, 2008 / Proposed Rules
(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
VerDate Aug<31>2005
15:24 Apr 10, 2008
Jkt 214001
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 higherrisk 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
PO 00000
Frm 00004
Fmt 4702
Sfmt 4702
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 higheractivity 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
E:\FR\FM\11APP1.SGM
11APP1
ebenthall on PRODPC61 with PROPOSALS
Federal Register / Vol. 73, No. 71 / Friday, April 11, 2008 / Proposed Rules
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
VerDate Aug<31>2005
15:24 Apr 10, 2008
Jkt 214001
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
PO 00000
Frm 00005
Fmt 4702
Sfmt 4702
19753
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
E:\FR\FM\11APP1.SGM
11APP1
ebenthall on PRODPC61 with PROPOSALS
19754
Federal Register / Vol. 73, No. 71 / Friday, April 11, 2008 / Proposed Rules
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
VerDate Aug<31>2005
15:24 Apr 10, 2008
Jkt 214001
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
PO 00000
Frm 00006
Fmt 4702
Sfmt 4702
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
E:\FR\FM\11APP1.SGM
11APP1
Federal Register / Vol. 73, No. 71 / Friday, April 11, 2008 / Proposed Rules
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.
ebenthall on PRODPC61 with PROPOSALS
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, computerreadable 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 online. 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
VerDate Aug<31>2005
15:24 Apr 10, 2008
Jkt 214001
19755
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 computerreadable 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.
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 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.
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.
D.4.1 Reporting Initial (Current)
Inventory to the NSTS
As noted, licensees would be required
to report their initial (i.e., current)
PO 00000
Frm 00007
Fmt 4702
Sfmt 4702
D.4.2 Annual Reconciliation and
Verification of Information in the NSTS
E:\FR\FM\11APP1.SGM
11APP1
19756
Federal Register / Vol. 73, No. 71 / Friday, April 11, 2008 / Proposed Rules
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.
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.
ebenthall on PRODPC61 with PROPOSALS
D.4.3.1 Reporting Information on
Source Manufacture
D.4.3.2 Reporting Information on
Source Transfer
Sources Manufactured in the United
Transfers between licensees: Each
States: When a nationally tracked
time a nationally tracked source is
source is manufactured in the United
transferred to another facility authorized
States, the source manufacturer licensee to use or possess the source, the licensee
would be required to report the source
would be required to report the transfer
information to the NSTS. The
to the NSTS by the close of the next
information must be reported by the
business day. The licensee must report
close of the next business day after
the recipient name (facility the source is
manufacture and includes:
being transferred to), address, license
Manufacturer (make), model number,
number, the shipping date, the
serial number, radioactive material,
estimated arrival date, and the
activity at manufacture, and
identifying source information
manufacture date for each source. The
(manufacturer, model number, serial
licensee must also provide its license
number, and radioactive material). The
number, facility name, as well as the
licensee also would need to provide its
name of the individual that prepared the name, address, and license number, as
report.
well as the name of the individual
Recycled, Reconfigured, and
making the report. For nationally
Disassembled Sources: Some sources are tracked sources that are transferred as
recycled, reconfigured, or disassembled. waste under a Uniform Low-level
For example, a source that has decayed
Radioactive Waste Manifest, the
below its usefulness may be returned to licensee would also have to report the
the manufacturer for reconfiguration or
waste manifest number and the
disassembly. The decayed source may
container identification number for the
be placed in a reactor and reactivated,
container with the nationally tracked
or placed in storage. The source retains
source.
its serial number, but now has a new
Transfers where the source stays
activity. The new activity and creation
within the licensee’s possession: Source
date of the source must be reported to
transfer transactions only cover transfers
the NSTS.
between different licensees and/or
Imported Sources: For every
authorized facilities. They do not
nationally tracked source that is
include transfer to a temporary job site.
imported, the facility obtaining the
Transactions in which the nationally
source would be required to report the
tracked source remains in the
information on the manufacture of the
possession of the licensee would not
source to the NSTS by the close of the
require a report to the NSTS. For
next business day after receipt of the
example, a radiographer conducting
imported source at the site. For the
business would not need to report
purposes of the NSTS, this would be
transfers between temporary job sites,
considered the source origin unless the
even if the temporary job site is located
source had been previously possessed in in another state or if the work is
the United States. The licensee would
conducted under a reciprocity
need to report the manufacturer (make), agreement.
Export of sources: Export of sources
model number, serial number,
would be treated as a transfer. An export
radioactive material, activity at
is considered a reversible endpoint (e.g.,
manufacture or import, and
a place of use or storage that is not a
manufacture or import date for each
temporary job site) because the source
source. The licensee must also provide
can be imported back into the country.
its license number, facility name,
VerDate Aug<31>2005
15:24 Apr 10, 2008
Jkt 214001
PO 00000
Frm 00008
Fmt 4702
Sfmt 4702
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
E:\FR\FM\11APP1.SGM
11APP1
Federal Register / Vol. 73, No. 71 / Friday, April 11, 2008 / Proposed Rules
ebenthall on PRODPC61 with PROPOSALS
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-
VerDate Aug<31>2005
15:24 Apr 10, 2008
Jkt 214001
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
PO 00000
Frm 00009
Fmt 4702
Sfmt 4702
19757
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.
E:\FR\FM\11APP1.SGM
11APP1
19758
Federal Register / Vol. 73, No. 71 / Friday, April 11, 2008 / Proposed Rules
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.
ebenthall on PRODPC61 with PROPOSALS
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),
§ 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.
VerDate Aug<31>2005
15:24 Apr 10, 2008
Jkt 214001
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,
PO 00000
Frm 00010
Fmt 4702
Sfmt 4702
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: https://www.nrc.gov/public-involve/
doc-comment/omb/ for 60
days after the signature date of this
notice.
Send comments on any aspect of
these proposed information collections,
E:\FR\FM\11APP1.SGM
11APP1
Federal Register / Vol. 73, No. 71 / Friday, April 11, 2008 / Proposed Rules
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
INFOCOLLECTS@NRC.GOV 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 https://
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.
ebenthall on PRODPC61 with PROPOSALS
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
VerDate Aug<31>2005
15:24 Apr 10, 2008
Jkt 214001
20852. Single copies of the draft
regulatory analysis are available from
Michael Williamson, telephone (301)
415–6284, e-mail mkw1@nrc.gov, 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
PO 00000
Frm 00011
Fmt 4702
Sfmt 4702
19759
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 (§§ 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,
E:\FR\FM\11APP1.SGM
11APP1
19760
Federal Register / Vol. 73, No. 71 / Friday, April 11, 2008 / Proposed Rules
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 § 20.1003, the definition
nationally tracked source is revised to
read as follows:
§ 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
Radioactive material
ebenthall on PRODPC61 with PROPOSALS
Actinium–227 .......................
Americium–241 ....................
Americium–241/Be ...............
Californium–252 ...................
Cobalt–60 .............................
Curium–244 ..........................
Cesium–137 .........................
Gadolinium–153 ...................
Iridium–192 ..........................
Plutonium–238 .....................
Plutonium–239/Be ................
Polonium–210 ......................
Promethium–147 ..................
Radium–226 .........................
Selenium–75 ........................
Strontium–90 ........................
Thorium–228 ........................
Thorium–229 ........................
Thulium–170 ........................
Ytterbium–169 ......................
*
*
*
*
*
(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
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.
Category 1
(Ci)
Category 2
(TBq)
Category 2
(Ci)
Category 3
(TBq)
Category 3
(Ci)
20
60
60
20
30
50
100
1,000
80
60
60
60
40,000
40
200
1,000
20
20
20,000
300
540
1,600
1,600
540
810
1,400
2,700
27,000
2,200
1,600
1,600
1,600
1,100,000
1,100
5,400
27,000
540
540
540,000
8,100
0.2
0.6
0.6
0.2
0.3
0.5
1
10
0.8
0.6
0.6
0.6
400
0.4
2
10
0.2
0.2
200
3
5.4
16
16
5.4
8.1
14
27
270
22
16
16
16
11,000
11
54
270
5.4
5.4
5,400
81
.02
0.06
0.06
0.02
0.03
0.05
0.01
1
0.08
0.06
0.06
0.06
40
0.04
0.02
1
0.02
0.02
20
0.03
1⁄10 of
Category 3
(TBq)
0.54
1.6
1.6
0.54
0.81
1.4
2.7
27
2.2
1.6
1.6
1.6
1100
1.1
5.4
27
0.54
0.54
540
8.1
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.
15:24 Apr 10, 2008
§ 20.2207 Reports of transactions
involving nationally tracked sources.
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:
Category 1
(TBq)
PART 32—SPECIFIC DOMESTIC
LICENSES TO MANUFACTURE OR
TRANSFER CERTAIN ITEMS
CONTAINING BYPRODUCT MATERIAL
VerDate Aug<31>2005
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 § 20.2207, paragraph (h) is
revised to read as follows:
Jkt 214001
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 § 32.2, the definition nationally
tracked source is revised to read as
follows:
PO 00000
Frm 00012
Fmt 4702
Sfmt 4702
§ 32.2
0.002
0.006
0.006
0.002
0.003
0.005
0.001
0.1
0.008
0.006
0.006
0.006
4
0.004
0.002
0.10
0.002
0.002
2
0.003
1⁄10 of
Category 3
(Ci)
0.054
0.16
0.16
0.054
0.081
0.14
0.27
2.7
0.22
0.16
0.16
0.16
110
0.11
0.54
2.7
0.054
0.054
54
0.81
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
E:\FR\FM\11APP1.SGM
11APP1
Federal Register / Vol. 73, No. 71 / Friday, April 11, 2008 / Proposed Rules
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]
You may submit comments,
identified by RIN 1990–AA30, by any of
the following methods:
Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
E-mail:
Martha.Thompson@hq.doe.gov.
Mail: Martha Thompson, Deputy
Director, (HS–40), Office of
Enforcement, Office of Health, Safety
and Security, U.S. Department of
Energy, 20300 Century Blvd.,
Germantown, Maryland 20874.
You may obtain copies of comments
received by DOE from the Office of
Health, Safety and Security Web site:
https://www.hss.energy.gov/Enforce/ or
by contacting Martha Thompson of the
Office of Enforcement.
FOR FURTHER INFORMATION CONTACT:
Sophia Angelini, Attorney-Advisor (GC–
52), Office of the General Counsel, U.S.
Department of Energy, 1000
Independence Avenue, SW.,
Washington, DC 20585, (202) 586–6975;
or Martha Thompson, Deputy Director
(HS–40), Office of Enforcement, Office
of Health, Safety and Security, U.S.
Department of Energy, 20300 Century
Blvd., Germantown, Maryland 20874,
(301) 903–5018 or by e-mail,
martha.thompson@hq.doe.gov.
ADDRESSES:
SUPPLEMENTARY INFORMATION:
BILLING CODE 7590–01–P
I. Background
II. Discussion of the Proposed Rule
III. Public Comment Procedures
IV. Regulatory Review
DEPARTMENT OF ENERGY
I. Background
10 CFR Part 820
RIN 1990–AA30
Procedural Rules for DOE Nuclear
Activities
Department of Energy.
Notice of proposed rulemaking.
AGENCY:
ebenthall on PRODPC61 with PROPOSALS
ACTION:
SUMMARY: The Department of Energy
(DOE) is proposing to amend its
Procedural Rules for DOE Nuclear
Activities to be consistent with section
610 of the Energy Policy Act of 2005,
Public Law 109–58 (EPAct 2005), signed
into law by President Bush on August
8, 2005. Section 610 amends provisions
in section 234A. of the Atomic Energy
Act of 1954 (AEA) concerning civil
penalties with respect to certain DOE
contractors, subcontractors and
suppliers. This proposed rule would
revise DOE’s regulations to be consistent
with the changes made by section 610.
DATES: Public comments on this
proposed rule will be accepted until
May 27, 2008.
VerDate Aug<31>2005
16:22 Apr 10, 2008
Jkt 214001
In 1988, Congress amended the
Atomic Energy Act of 1954 (AEA) (42
U.S.C. 2011 et seq.) by adding section
234A. (commonly referred to as the
Price-Anderson Act) (42 U.S.C. 2282a.)
that establishes a system of civil
penalties for DOE contractors,
subcontractors, and suppliers that are
covered by an indemnification
agreement under section 170d. of the
AEA (42 U.S.C. 2210d.). The civil
penalties cover DOE contractors,
subcontractors and suppliers that
violate, or whose employees violate, any
applicable rule, regulation or order
related to nuclear safety issued by the
Secretary of Energy. Section 234A.
specifically exempted seven institutions
(and any subcontractors or suppliers
thereto) from such civil penalties and
directed the Secretary of Energy to
determine by rule whether nonprofit
educational institutions should receive
automatic remission of any penalty. On
August 17, 1993, DOE promulgated
‘‘Procedural Rules for DOE Nuclear
Activities,’’ codified at 10 CFR Part 820
(Part 820), to provide for the
PO 00000
Frm 00013
Fmt 4702
Sfmt 4702
19761
enforcement under section 234A. of the
AEA of DOE nuclear safety
requirements. Under Part 820, the
exemption provision for the seven
institutions is set forth in section
820.20(c); the provision for an automatic
remission of civil penalties for
‘‘nonprofit educational institutions’’ is
in section 820.20(d).
DOE is proposing to amend subpart B
of Part 820 to incorporate the changes
required by section 610 of EPAct 2005.
Section 610, entitled ‘‘Civil Penalties,’’
amended section 234A. of the AEA by:
(1) Repealing the automatic remission
of civil penalties by striking the last
sentence of subsection 234A.b.(2) which
reads: ‘‘In implementing this section,
the Secretary shall determine by rule
whether nonprofit educational
institutions should receive automatic
remission of any penalty under this
section.’’;
(2) Deleting exemptions provided to
seven institutions (including their
subcontractors and suppliers) for
activities at certain facilities by deleting
existing subsection 234A.d. and
substituting a new subsection
234A.d.(1) in which the total amount of
civil penalties for violations under
subsection 234A.a. of the AEA by any
not-for-profit contractor, subcontractor,
or supplier may not exceed the total
amount of fees paid within any 1-year
period (as determined by the Secretary)
under the contract; and
(3) Adding a new section 234A.d.(2)
that defines the term ‘‘not-for-profit’’ to
mean that ‘‘no part of the net earnings
of the contractor, subcontractor, or
supplier inures to the benefit of any
natural person or for-profit artificial
person.’’
Finally, section 610 of EPAct 2005
included an effective date provision at
subsection 234A.c., specifying that the
amendments as to civil penalties under
section 234A. shall not apply to any
violation of the AEA occurring under a
contract entered into before the date of
enactment of EPAct 2005, which was
August 8, 2005.
II. Discussion of the Proposed Rule
Today’s proposed rule would amend
section 820.20 as follows:
(1) It would revise paragraph (c) to
limit the exemption for seven
institutions (and their subcontractors
and suppliers) from the civil penalty
provisions of Part 820 to violations
occurring under contracts entered into
before the date of enactment of EPAct
2005;
(2) It would revise paragraph (d) to
limit the automatic remission of civil
penalties for nonprofit educational
institutions under Part 820 to violations
E:\FR\FM\11APP1.SGM
11APP1
Agencies
[Federal Register Volume 73, Number 71 (Friday, April 11, 2008)]
[Proposed Rules]
[Pages 19749-19761]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-7756]
========================================================================
Proposed Rules
Federal Register
________________________________________________________________________
This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.
========================================================================
Federal Register / Vol. 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.
-----------------------------------------------------------------------
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: Rulemaking.Comments@nrc.gov. 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 https://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 https://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 pdr@nrc.gov.
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, mkw1@nrc.gov.
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:
---------------------------------------------------------------------------
\1\ RS-G-1.9 ``Categorization of Radioactive Sources.''
---------------------------------------------------------------------------
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