[Federal Register Volume 70, Number 144 (Thursday, July 28, 2005)]
[Proposed Rules]
[Pages 43646-43659]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-14919]
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Proposed Rules
Federal Register
________________________________________________________________________
This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.
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Federal Register / Vol. 70, No. 144 / Thursday, July 28, 2005 /
Proposed Rules
[[Page 43646]]
NUCLEAR REGULATORY COMMISSION
10 CFR Parts 20, 32, and 150
RIN: 3150-AH48
National Source Tracking of Sealed Sources
AGENCY: Nuclear Regulatory Commission.
ACTION: Proposed rule.
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SUMMARY: The Nuclear Regulatory Commission (NRC) is proposing to amend
its regulations to implement a National Source Tracking System for
certain sealed sources. The proposed amendments would require licensees
to report certain transactions involving these sealed sources to the
National Source Tracking System. These transactions would include
manufacture, transfer, receipt, 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
National Source Tracking System and annually verify and reconcile the
information in the system with the licensee's actual inventory. In
addition, the proposed amendment would require manufacturers to assign
a unique serial number to each nationally tracked source.
DATES: Submit comments on the rule by October 11, 2005. Submit comments
specific to the information collections aspects of this rule by August
29, 2005. Comments received after the above dates will be considered if
it is practical to do so, but assurance of consideration cannot be
given to comments received after these dates.
ADDRESSES: You may submit comments by any one of the following methods.
Please include the following number (RIN 3150-AH48) 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
on the NRC rulemaking Web site. Personal information will not be
removed from your comments.
Mail comments to: Secretary, U.S. Nuclear Regulatory Commission,
Washington, DC 20555-0001, ATTN: Rulemakings and Adjudications Staff.
E-mail comments to: [email protected]. If you do not receive a reply e-
mail confirming that we have received your comments, contact us
directly at (301) 415-1966. You may also submit comments via the NRC's
rulemaking Web site at http://ruleforum.llnl.gov. Address questions
about our rulemaking Web site to Carol Gallagher (301) 415-5905; e-mail
[email protected]. Comments can also be submitted via the Federal Rulemaking
Portal http://www.regulations.gov.
Hand deliver comments to: 11555 Rockville Pike, Rockville, Maryland
20852, between 7:30 a.m. and 4:15 p.m. Federal workdays. (Telephone
(301) 415-1966).
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
examined and copied for a fee at the NRC's Public Document Room (PDR),
Public File Area O1 F21, One White Flint North, 11555 Rockville Pike,
Rockville, Maryland. Selected documents, including comments, can be
viewed and downloaded electronically via the NRC rulemaking Web site at
http://ruleforum.llnl.gov.
Publicly available documents created or received at the NRC after
November 1, 1999, are available electronically at the NRC's Electronic
Reading Room at http://www.nrc.gov/NRC/ADAMS/index.html. From this
site, the public can gain entry into the NRC's Agencywide Document
Access and Management System (ADAMS), which provides text and image
files of NRC's public documents. If you do not have access to ADAMS or
if there are problems in accessing the documents located in ADAMS,
contact the NRC Public Document Room (PDR) Reference staff at 1-800-
397-4209, 301-415-4737 or by e-mail to [email protected].
FOR FURTHER INFORMATION CONTACT: Merri Horn, Office of Nuclear Material
Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington,
DC 20555-0001, telephone (301) 415-8126, e-mail, [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
II. Discussion
A. What Action Is the NRC Taking?
B. What Is a Nationally Tracked Source?
C. Who Would This Action Affect?
D. How Would Information Be Reported to the National Source
Tracking System?
E. Would a Licensee Need to Report Its Current Inventory To the
System?
F. What Information Would Be Collected on Source Origin?
G. What Information Would Be Collected on Source Transfer?
H. What Information Would Be Reported for Receipt of Sources?
I. What Information Would Be Reported on Source Endpoints?
J. How Would the National Source Tracking System Information Be
Kept Current?
K. How Would Incorrect Information Be Changed in the National
Source Tracking System?
L. Some Licensees Now Must Report Similar Information to the
Nuclear Materials Management Safeguards System. Would This Rule
Result in a Duplication in Reporting?
M. Are the Proposed Actions Consistent With International
Obligations?
N. When Do These Actions Become Effective?
O. Who Would have Access to the Information and What Would It Be
Used For?
P. What Other Things Would Be Required by the Proposed Action?
Q. What Should I Consider as I Prepare My Comments to NRC?
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
As a result of the terrorist attacks in the United States on
September 11, 2001, the NRC has undertaken a comprehensive review of
nuclear material security requirements, with particular focus on
radioactive material of concern. This material (which includes Cobalt-
60, Cesium-137, Iridium-192, and Americium-241
[[Page 43647]]
isotopes, as well as other isotopes) has the potential to be used in a
radiological dispersal device (RDD) or a radiological exposure device
(RED) in the absence of proper security measures. The NRC's review
takes 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, entitled, ``Radiological Dispersal Devices: An
Initial Study to Identify Radioactive Materials of Greatest Concern and
Approaches to Their Tracking, Tagging, and Disposition'' is available
on the DOE Web site at: http://www.energy.gov/engine/doe/files/dynamic/9620039919_RDDRPTF14MAY.pdf. One of the recommendations
contained in the report is that a national source tracking system be
developed to better understand and monitor the location and movement of
sources of interest. The full report contains a list of radionuclides
and thresholds above which tracking of the sources is recommended. Note
that in the public version the table of radionuclides has been
redacted.
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 at http://www-pub.iaea.org/MTCD/publications/PDF/Code-2004.pdf. In particular, the Code of Conduct recommends that each IAEA
member State develop a national source registry of radioactive sources
that should include Category 1 and 2 radioactive sources as described
in Annex 1 of the Code of Conduct. The recommendation covers 16
isotopes that should be included in the source registry.
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.'' TECDOC-1344 provides the
underlying methodology for the development of the Code of Conduct
thresholds. 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 the domestic and international efforts to
increase the safety and security of radioactive sources, NRC has
adopted the Category 2 values.
The U.S. Government has formally notified the Director General of
the IAEA of its strong support for the current Code of Conduct.
Although the Code of Conduct does not have the stature of an
international treaty, and its provisions are non-binding on IAEA member
States, the U.S. Government has endorsed the Code of Conduct and is
working toward implementation of its various provisions. The Commission
is conducting this rulemaking and an import/export rulemaking to
reflect those Code of Conduct recommendations which are consistent with
NRC responsibilities under the Atomic Energy Act, including promotion
of the common defense and security. This is the second rulemaking that
the Commission has undertaken to implement provisions of the Code of
Conduct. A final rule addressing the import/export of Category 1 and 2
radioactive materials was published on July 1, 2005 (70 FR 37985).
Efforts to improve controls over sealed sources face significant
challenges, especially balancing the need to secure 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; are used in a variety of
military applications; 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.
National source tracking is part of a comprehensive radioactive
source control program for radioactive materials of greatest concern.
Although neither a national source tracking system nor source registry
can ensure the physical protection of sources, it will provide greater
source accountability which will foster increased control by licensees.
A national source tracking system in conjunction with controls such as
those imposed by Orders on irradiator licensees, manufacturer and
distributor licensees, and other material licensees will result in
improved security for radioactive sources.
There is clearly broad U.S. Government and international interest
in tracking radioactive sources to improve accountability and control.
Currently, there is no single U.S. source of information to verify the
licensed users, locations, quantities and movement of these materials.
Separate NRC and Agreement State systems contain information on
licensees and the maximum amounts of materials they are authorized to
possess but do not record actual sources or their movements.
To address this lack of information on such issues as actual
material possessed, the NRC, with the cooperation of the Agreement
States, began working on an interim database of sources of concern. In
November 2003, both NRC and Agreement State licensees were contacted
and requested to voluntarily provide some basic information on the
sealed sources located at their facilities. Of the approximately 2600
licensees contacted, over half of the licensees reported possessing
Category 1 or Category 2 sealed sources. The interim database will be
updated in 2005 and again in 2006 and will ultimately be replaced by
the National Source Tracking System. While the interim database
provides a snapshot in time, the National Source Tracking System will
provide information on an ongoing basis.
Development of the National Source Tracking System is a two-part
activity that includes both a rulemaking and information technology
development. When completely operational, the National Source Tracking
System will be a web-based system that would allow licensees to meet
the proposed reporting requirements on-line with ease. The system will
contain information on NRC licensees, Agreement State licensees, and
DOE facilities. This proposed rulemaking would impose requirements on
both NRC and Agreement State licensees and would establish the
regulatory foundation for the National Source Tracking System
recommended in the DOE/NRC report and implement the Code of Conduct
recommendation to develop a source registry. National Source Tracking
is being developed and would be implemented under the NRC's statutory
authority to promote the common defense and security. To
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inform the development of the National Source Tracking System, the NRC
established an Interagency Coordinating Committee to provide guidance
regarding interagency issues associated with the development,
coordination, and implementation of the system and to prevent licensees
from receiving similar requests from more than one agency. The
Committee membership consists of representatives from various Federal
Agencies with an interest in source security and a representative from
the Agreement States. The views of the Committee were included in the
development of the requirements for the National Source Tracking System
and this rulemaking. NRC will be the database manager of the National
Source Tracking System, however, the other agencies may become users of
the system and have limited access.
II. Discussion
A. What Action Is the NRC Taking?
The NRC is proposing a rule that would implement a new program
called the National Source Tracking System. The proposed rule would
require licensees to report information on the manufacture, transfer,
receipt, and disposal of nationally tracked sources. This information
would capture the origin of each nationally tracked source
(manufacture, recycling, or import), all transfers to other licensees,
all receipts of nationally tracked sources, and endpoints of each
nationally tracked source (disposal or export). Ultimately, the
National Source Tracking System would be able to provide a life history
account of all nationally tracked sources.
A system of this type would need prompt updating 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. To ease the
burden on licensees, the NRC is planning to establish a secure
Internet-based interface to the National Source Tracking System. This
interface would permit licensees access to the system using an Internet
browser. Licensees would log on to the system and enter the required
information by filling out a form on-line. While on-line access should
be fast, accurate, and convenient for licensees, the NRC would also
allow licensees the option of completing and mailing or faxing paper
forms. In addition, licensees would also be able to provide batch
information using a computer readable format file. The format will be
specified in a guidance document on implementation of the National
Source Tracking System.
B. What Is 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. A nationally
tracked source is a sealed source containing a quantity of radioactive
material equal to or greater than the Category 2 levels listed in the
proposed new Appendix E to 10 CFR part 20. A nationally tracked source
may be either a Category 1 source or a Category 2 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.
Category 1 nationally tracked sources are those containing a
quantity equal to or greater than the Category 1 threshold. Category 2
nationally tracked sources are those containing a quantity equal to or
greater than the Category 2 threshold but less than the Category 1
threshold. This definition is based on the IAEA Code of Conduct and is
consistent with the definition of sealed sources in other parts of the
NRC regulations and with definitions contained in Agreement State
regulations.
The specific radioactive material and amounts covered by this rule
are listed in the proposed Appendix E to part 20. The isotopes and
thresholds of 15 of the isotopes are identical to the Table I values
from the Code of Conduct. The IAEA Code of Conduct includes a
recommendation that these isotopes and thresholds be included in a
national source registry. The U.S. Government has formally endorsed
these values. The NRC has adopted the Category 2 values to allow
alignment between domestic and international efforts to increase the
safety and security of radioactive sources.
The Terabecquerel (TBq) values listed in 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 practical
usefulness only and are rounded after conversion. The curie values are
not intended to be the regulatory standard.
Table I of the IAEA Code of Conduct actually lists 16 isotopes that
should be included in a national source registry. Included in this
listing is radium (Ra)-226. Because NRC does not regulate Ra-226, it
will not be subject to the proposed rule requirements. However, the
National Source Tracking System will allow licensees to voluntarily
enter transactions for Ra-226 sealed sources. Additionally, States may
decide to develop regulations that require their licensees to report
Ra-226 transactions to the State. The NRC could decide to allow such
transaction reports to be recorded in the National Source Tracking
System. The Category 2 threshold for Ra-226 is 0.4 TBq.
The Commission recognizes that by allowing voluntary reporting, the
Ra-226 information in the National Source Tracking System will not be
reliable. Some licensees might report their Ra-226 transactions and
others might not. This could result in one-sided transactions in the
system. For example, a licensee may report the transfer of a Ra-226
source but the recipient may not report its receipt of the Ra-226
source. However, there were no Ra-226 sealed sources reported to the
interim database, and while this does not mean that there are no Ra-226
sealed sources (the interim database survey did not go to the entire
population of facilities that could possess Ra-226), the Commission
believes that the inclusion of voluntary reporting of Ra-226 sealed
sources will allow the U.S. Government to more fully address the Code
of Conduct recommendation for a source registry. The NRC specifically
invites comment on whether States would be willing to develop
regulations that would require their licenses to report Ra-226 to
either the State or to the National Source Tracking System.
The Commission has expanded the National Source Tracking System
list of isotopes to include 6 isotopes that are not on the Code of
Conduct list and one isotope that is listed in the Code of Conduct but
is not included in the recommendation for the source registry. The 7
additional isotopes to be included are actinium (Ac)-227, plutonium
(Pu)-236, Pu-239, Pu-240, polonium-210, thorium (Th)-228, and Th-229.
The
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DOE/NRC RDD report recommendation for a National Source Tracking System
included these 7 isotopes. The thresholds were developed using the same
methodology as those listed in the Code of Conduct. These isotopes were
included in the interim database. Based on information from the interim
database, NRC and Agreement State licensees do not possess large
numbers of nationally tracked sources containing these isotopes.
However, this is a national system and will include information from
DOE facilities. DOE facilities are more likely to possess these
isotopes and DOE agreed that these isotopes should be included.
Therefore, the Commission is including them in this rulemaking.
At this time, the NRC does not plan to include Category 3 sources
(sources at 1/10th of the Category 2 threshold). However, we may
consider the inclusion of Category 3 sources in the future because a
licensee possessing a large number of Category 3 sources could present
a security concern. An item level tracking system cannot include
aggregation of sources because the sources may move in and out of the
tracking system with changes in ownership. For example, a manufacturer
could possess enough material that a Category 3 source would be
reported, however, a licensee receiving the Category 3 source may not
need to report the receipt because this is its only source. The
tracking system would have information on the manufacture and transfer
of the source, but not on its receipt. The data on Category 3 sources
could quickly become unreliable. The best way to address the concern of
aggregation within an item-level tracking system would be to the lower
the threshold for tracking so that all parties would be required to
report transactions.
The NRC specifically invites comment on the inclusion of Category 3
sources in the National Source Tracking System. We are interested in
information concerning:
(1) The number of additional licensees that would be impacted;
(2) The number of Category 3 sources possessed by licensees; and
(3) How often those sources change hands.
This information will enable the NRC to make a more informed
decision on the inclusion of Category 3 sources in the National Source
Tracking System. Category 3 sources are typically used in fixed
industrial gauges involving high activity sources (e.g., level gauges,
dredger gauges, conveyor gauges, and spinning pipe gauges) and in high
dose rate remote afterloaders for medical therapy.
C. Who Would This Action Affect?
The proposed rule would apply to any person (entity or individual)
in possession of a Category 1 or Category 2 source. It would apply to--
All licensees, both those with NRC licenses and those with
Agreement State licenses;
Manufacturers and distributors of Category 1 and Category 2
sources;
Medical facilities, radiographers, irradiators, reactors, and any
other licensees that are the end users of nationally tracked sources;
and
Disposal facilities and waste brokers.
The proposed rule would apply whether the source is actively used
or in long-term storage.
Nationally tracked sources are possessed by all types of licensees,
but primarily by byproduct material licensees. Nationally tracked
sources are used in the oil and gas, electrical power, construction,
medical, and food industries. They are used in a variety of military
applications and in technology research and development. Nationally
tracked sources are classified either Category 1 or 2 based on the
activity level of the radioactive material of concern. Category 1
sources are typically used in devices such as radiothermal generators
and irradiators, and in practices such as radiation teletherapy.
Category 2 sources are typically used in industrial gamma radiography,
blood irradiators, and some well logging.
D. How Would Information Be Reported to the National Source Tracking
System?
Licensees would have several options for reporting transaction
information to the National Source Tracking System. These methods would
include on-line, computer-readable format files, paper, fax, and
telephone. For most licensees, the most convenient, least burdensome
method will be to report the information on-line. To report information
on-line, a licensee would need to establish an account with the
National Source Tracking System. 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.
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 National Source Tracking System would 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. The computer-readable format that would be used has
not been developed yet. NRC and the company responsible for developing
the National Source Tracking System 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.
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. Additionally, licensees would be able to provide
transaction information by telephone and then follow-up with a paper
copy. Additional guidance on submitting information will be provided
when the final rule is published. The guidance would contain mailing
addresses and telephone and fax numbers for providing information to
the National Source Tracking System, as well as information on the
computer-readable format to be used.
E. Would a Licensee Need To Report Its Current Inventory to the System?
Yes, licensees would be required to report their current inventory
of nationally tracked sources by a specified date. There would be
separate report dates for Category 1 and Category 2 level nationally
tracked sources. Licensees would be required to report all Category 1
sources to the National Source Tracking System by December 31, 2006,
and all Category 2 sources by March 31, 2007.
To ease the reporting process, information already in the interim
database would be downloaded to the National Source Tracking System.
Each licensee that reported information to the interim database would
be provided a
[[Page 43650]]
copy of its information and asked to either verify the information or
provide updated information. NRC staff and the company that will
operate the National Source Tracking System will work with licensees to
make sure the inventory information is correct. Licensees that did not
provide information to the interim database would need to report the
information on its nationally tracked source inventory by the specified
dates. Disposal facilities would not need to report sources that have
already been buried or otherwise disposed.
F. What Information Would Be Collected on Source Origin?
Each time a nationally tracked source is manufactured in the United
States, the licensee would be required to report the source information
to the National Source Tracking System. The information must be
reported by the close of the next business day. The licensee would
report the 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.
Some sources are recycled or reconfigured. For example, a source
that has decayed below its usefulness is sometimes returned to the
manufacturer for reconfiguration. The decayed source may be placed in a
reactor and reactivated. The source retains its serial number, but now
has a new activity. The new activity and date must be reported to the
National Source Tracking System.
For every nationally tracked source that is imported, the facility
obtaining the source would be required to report the source information
to the National Source Tracking System by the close of the next
business day after receipt of the imported source at the site. For the
purposes of the National Source Tracking System, 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, 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.
Under separate regulations on import/export of radioactive
material, the NRC will be notified on imports of radioactive material
at Category 2 levels or above (70 FR 37985; July 1, 2005). This
notification should include source identification information. NRC
staff would enter the notification information into the National Source
Tracking System. Therefore, a licensee that is receiving imported
nationally tracked sources may be able to report the transaction as a
simple receipt, if using the on-line method. Much of the source
information would already be in the National Source Tracking System;
the licensee would be able to click on the pending import and then
click on the source to indicate that the source had been received at
the site.
G. What Information Would Be Collected on Source Transfer?
Each time a nationally tracked source is transferred to another
authorized facility, the licensee would be required to report the
transfer to the National Source Tracking System by the close of the
next business day. The licensee must report the recipient name
(facility the source is being transferred to) and license number, the
shipping date, the estimated arrival date, and the identifying source
information (manufacturer, model number, serial number, and radioactive
material). If the source is being exported, the export license number
would be reported for the recipient's license number. The licensee also
would need to provide its name 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.
Source transfer transactions only cover transfers between different
licensees and/or authorized facilities (DOE site or an export). 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 National Source Tracking System. 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. The NRC specifically invites comment on whether
licensees should be required to report as a transaction the use of a
nationally tracked source at temporary job sites. Specifically should
the NRC require reporting of:
(1) All transactions involving the use of a nationally tracked
source at a temporary job site;
(2) Any transactions involving the use of a nationally tracked
source at a temporary job site in another state either under the same
license or a different license; or
(3) No transactions involving the use of a nationally tracked
source at a temporary job site (as proposed in the rule)? If the NRC
were to require reporting of transactions involving temporary job
sites, how much additional burden would be imposed on licensees and
what should the reporting timeframe be?
H. What Information Would Be Reported for 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 must include its facility name and license number and the name
of the individual that prepared the report. The licensee must also
provide the name and license number of the facility that sent the
source because this information is necessary to match the transactions.
If the source 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. 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
licensee who shipped the source. Because there is no verification that
the source is in the waste container, should the facility be required,
at a minimum, to investigate the container for any indication of
tampering? The NRC specifically invites comment on whether a waste
broker or disposal facility should be required to inspect the waste
container for an indication of tampering to provide additional
[[Page 43651]]
assurance the source is still in the container.
I. What Information Would Be Reported on Source Endpoints?
Endpoints for a source include export, disposal, decay, and
destruction of the source. Exports would be treated as a transfer. (See
Section G for more information on source transfer.) An export is
considered a reversible endpoint 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.
Disposal of a source would be reported by the licensee conducting
the actual burial in a low-level disposal facility or other authorized
disposal mechanism. Licensees sending a source to a low-level burial
ground for disposal would treat the transaction as a transfer, and
would report the types of information to be reported for a transfer,
including the waste manifest number and the container identification
number. 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 National Source Tracking System 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.
One feature of the National Source Tracking System 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 Category 2 levels, the source would be automatically
removed from a licensee's active inventory in the National Source
Tracking System. 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.
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 National Source Tracking
System. Because sealed sources are designed to be robust, accidental
destruction is rare. Examples of accidental destruction include sources
destroyed during attempts to remove them from devices, and well logging
sources that become disconnected downhole and destroyed during
retrieval attempts.
Other endpoints that would be captured by the National Source
Tracking System include a lost or stolen source or a source abandoned
in a well. These events are already reported to either NRC or to the
Agreement State. Licensees would not be required to report this
information a second time to the National Source Tracking System.
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 National Source Tracking System.
J. How Would the National Source Tracking System Information Be Kept
Current?
Data integrity for the National Source Tracking System is extremely
important and necessary to keep the information correct and up-to-date.
Licensees are expected to provide correct information to the National
Source Tracking System and should double-check the accuracy of
information before submission. To address quality assurance concerns on
the data, the NRC is considering adding a requirement that would
require licensees to double-check the accuracy of the data by using two
independent checkers before submission of the transaction report. The
NRC specifically invites comment on the inclusion of a requirement for
a quality assurance check of the data before submission. We are
interested in information concerning:
(1) Whether these are the appropriate requirements for quality
assurance;
(2) What are the appropriate requirements for quality assurance;
and
(3) The additional burden such a requirement would impose on
licensees.
If licensees accurately report their transactions in a timely
manner, the National Source Tracking System would contain correct, up-
to-date information. However, we recognize that some transactions may
be missed and that errors may be introduced into the system over time.
Typical reasons for discrepancies, which might nevertheless occur,
could be failure to report the receipt of a source, failure to report
the transfer of a source to another licensee, missing a source during
the reporting of the initial inventory, selection of the wrong model
number, or incorrectly typing the serial number. Each licensee would be
required to correct any errors or missed transactions that it discovers
within 5 business days of the discovery. In addition, licensees would
be required to reconcile their on-site inventory of nationally tracked
sources with the information previously reported to the National Source
Tracking System. This reconciliation would occur during the month of
June 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 National Source Tracking System. Licensees without on-line
access would receive a paper copy of the information in the National
Source Tracking System. 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. Licensees are currently required to
conduct physical inventories either 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 National Source Tracking System.
The licensee would be required to verify by the end of June of each
year that the inventory in the National Source Tracking System is
correct. The first reconciliation would occur in June 2007.
K. How Would Incorrect Information Be Changed in the National Source
Tracking System?
Each licensee would be responsible for correcting any incorrect
information in the National Source Tracking System, regardless of the
source 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 National Source Tracking System 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.
L. Some Licensees Now Must Report Similar Information to the Nuclear
Materials Management Safeguards System. Would This Rule Result in a
Duplication in Reporting?
Yes, some information on plutonium (Pu) and thorium (Th) would be
collected by both the Nuclear Materials Management Safeguards System
(NMMSS) and the National Source Tracking System. The current
regulations require reporting transfers,
[[Page 43652]]
receipts, and inventory to NMMSS for one gram or more of plutonium and
any thorium that has foreign obligations. However, NMMSS does not
collect information at the source level; therefore, the detailed
information (make, model, serial number) on sealed sources could not be
extracted from NMMSS to provide input into the National Source Tracking
System. The National Source Tracking System would only have information
on sealed sources and would not contain information on sources that are
not considered sealed or on any bulk material that a licensee may
possess. The thresholds are also different for the two systems.
Therefore, we would not be able to extract information from the
National Source Tracking System to support NMMSS. Neither system would
be able to collect the needed information for the other system without
modifications to the database and additional changes to the
regulations. The two system also have different purposes.
In practice, NRC finds that these Pu and Th sources are typically
held by licensees for long time periods and not routinely transferred
to other licensees, so incidences of double-reporting are expected to
be rare. No licensee reported Th sources to the interim database, and
there were only 21 Pu sealed sources reported that were above the
Category 2 threshold. The NRC does not believe that the limited number
of licensees and transactions likely to be affected by this dual
reporting requirement would impose an unnecessary burden. The NMMSS and
the National Source Tracking System would collect information on these
isotopes for different purposes and in different formats and with
different levels of detail and thresholds as needed by each system.
Therefore, the Commission believes that NMMSS and the National Source
Tracking System should remain separate.
M. Are the Proposed Actions Consistent With International Obligations?
Yes, the National Source Tracking System will be consistent with
international obligations. The system is intended to respond to the
recommendation in the IAEA Code of Conduct for development of a
national source registry.
N. When Do These Actions Become Effective?
The rule would become effective 60 days after the final rule is
published in the Federal Register. The requirements for Category 1
nationally tracked sources would be implemented by December 31, 2006.
This means that by this date any licensee that possesses a Category 1
level source must have reported its initial inventory and report
thereafter all transactions involving Category 1 sources to the
National Source Tracking System. The requirements for Category 2
nationally tracked sources would be implemented by March 31, 2007. By
this date, all licensees must have reported their initial inventory of
nationally tracked sources and report thereafter all transactions to
the National Source Tracking System.
O. Who Would Have Access to the Information and What Would It be Used
for?
Information in the National Source Tracking System will be
considered Official Use Only; the information will not be considered to
be Safeguards Information or Safeguards Information--Modified Handling.
A licensee would be able to view the data on its facility, but not data
on 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 will also be able to view the
information on lost or stolen sources and other information on a need-
to-know basis.
Licensees are not required to protect Official Use Only
information, it is the equivalent of company proprietary information
and licensees may share the information at their discretion. The NRC
specifically invites comment on whether this provides adequate
protection of the information or whether licensees should be required
to protect the information that is reported to the National Source
Tracking System. If additional protection should be necessary, what
level of protection is viewed to be necessary?
Once fully operational, the National Source Tracking System 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.
P. What Other Things Would Be Required by the Proposed Action?
The proposed rule would also 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 National Source Tracking System to track the history of each
source.
Q. What Should I Consider As I Prepare My Comments to NRC?
Tips for preparing your comments. When submitting your comments,
remember to:
i. Identify the rulemaking (RIN 3150-AH48).
ii. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
iii. Describe any assumptions and provide any technical information
and/or data that you used.
iv. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
v. Provide specific examples to illustrate your concerns, and
suggest alternatives.
vi. Explain your views as clearly as possible.
vii. Make sure to submit your comments by the comment period
deadline identified.
viii. See item B of the Discussion portion of this notice for NRC's
specific request for comments regarding State development of
regulations on R-226 and the future inclusion of Category 3 sources in
the National Source Tracking System. See item G of the Discussion
portion of this notice for the request for comments on requiring
licensees to report use of nationally tracked sources at temporary job
sites. See item H of the Discussion portion of this notice for the
request for comment on requiring waste brokers and disposal facilities
to inspect waste containers for an indication of tampering. See item J
of the Discussion portion of this notice for the request for comments
regarding the inclusion of a quality assurance provision on data
submission. See item O of the Discussion portion of this notice for the
request for comments on licensee protection of the information reported
to the National Source Tracking System. See section IX for the request
for comments on the information collection aspects and section XII for
the request for comments on the impacts to small businesses.
[[Page 43653]]
III. Discussion of Proposed Amendments by Section
Section 20.1003 Definitions
A definition of nationally tracked sources would be added to the
regulations.
Section 20.2207 Reports of Transactions Involving Nationally Tracked
Sources
A new section would be added to the regulations to require
licensees to report to the National Source Tracking System transactions
involving nationally tracked sources. New paragraph (a) Would require
the reporting of the manufacture of a nationally tracked source. New
paragraph (b) would require the reporting of all transfers of
nationally tracked sources to another authorized facility. New
paragraph (c) would require the reporting of all receipts of a
nationally tracked source. New paragraph (d) would require the
reporting of the disposal of any nationally tracked source. Each of
these paragraphs would require the licensee to report specific
information for the transaction, which would include for each source
information such as the manufacturer, model, serial number, radioactive
material, activity and activity date, and the transaction date. The
licensee would also need to provide the facility name, license number,
address, and name of the individual that prepared the report. If the
transaction involves the use of the Uniform Low-Level Radioactive Waste
Manifest, the licensee would need to report the waste manifest number
and the container identification for the container with the source.
New paragraph (e) would require licensees to report these
transactions to the National Source Tracking System by the close of the
next business day. The regulations would allow the licensee to report
the transactions either on-line, electronically using a computer-
readable format, by facsimile, by mail, or by telephone.
New paragraph (f) would require each licensee to correct any error
in a previously filed report or file a new report for a missed
transaction within 5 business days of the discovery of the error or
missed transaction. Each licensee would also be required to reconcile
and verify the information in the National Source Tracking System
during the month of June each year. This process would involve
comparing the inventory information in the National Source Tracking
System and the actual inventory possessed by the licensee. The proposed
amendment would require any discrepancies to be resolved by filing the
reports identified by paragraphs (a) through (d) described above.
New paragraph (g) would require a licensee to report its initial
inventory of Category 1 nationally tracked sources by December 31,
2006, and the inventory of Category 2 nationally tracked sources by
March 31, 2007.
Appendix E Nationally Tracked Source Thresholds
A new appendix would be added to part 20 that provides the
thresholds for nationally tracked sources at the Category 1 and
Category 2 levels. The Terabecquerel (TBq) values listed in 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 practical usefulness only and are rounded after conversion. The
curie values are not intended to be the regulatory standard.
Section 32.2 Definitions
A definition of nationally tracked sources would be added to the
regulations.
Section 32.201 Serialization of Nationally Tracked Sources
A new section would be added that requires manufacturers of
nationally tracked sources to assign a unique serial number to each
nationally tracked source that is manufactured after the effective date
of the rule.
Section 150.3 Definitions
A definition of nationally tracked sources would be added to the
regulations.
Section 150.15 Persons Not Exempt
A new section is added that would require source manufacturers
licensed by Agreement States to assign a unique serial number for each
nationally tracked source that is manufactured after the effective date
of the rule.
Section 150.18 Submission to Commission of Nationally Tracked Source
Transaction Reports
A new section would be added to the regulations to require
Agreement State licensees to report to the National Source Tracking
System all transactions involving nationally tracked sources. New
paragraph (a) would require the reporting of the manufacture of a
nationally tracked source. New paragraph (b) would require the
reporting of all transfers of nationally tracked sources to another
authorized facility. New paragraph (c) would require the reporting of
all receipts of a nationally tracked source. New paragraph (d) would
require the reporting of the disposal of any nationally tracked source.
Each of these paragraphs would require the licensee to report specific
information for the transaction, which would include for each source
information such as the manufacturer, model, serial number, radioactive
material, activity and activity date, and the transaction date. The
licensee would also need to provide the facility name, license number,
address, and name of the individual that prepared the report. If the
transaction involves the use of the Uniform Low-Level Radioactive Waste
Manifest, the licensee would need to report the waste manifest number
and the container identification for the container with the source.
New paragraph (e) would require licensees to report these
transactions to the National Source Tracking System by the close of the
next business day. The regulations would allow the licensee to report
the transactions either on-line, electronically using a computer-
readable format, by facsimile, by mail, or by telephone.
New paragraph (f) would require each licensee to correct any error
in a previously filed report or file a new report for a missed
transaction within 5 business days of the discovery of the error or
missed transaction. Each licensee would also be required to reconcile
and verify the information in the National Source Tracking System
during the month of June each year. This process would involve
comparing the inventory information in the National Source Tracking
System and the actual inventory possessed by the licensee. The proposed
amendment would require any discrepancies to be resolved by filing the
reports identified by paragraphs (a) through (d) described above.
New paragraph (g) would require a licensee to report its initial
inventory of Category 1 nationally tracked sources by December 31,
2006, and the inventory of Category 2 nationally tracked sources by
March 31, 2007.
IV. Criminal Penalties
For the purpose of section 223 of the Atomic Energy Act (AEA), the
Commission is proposing to amend 10 CFR parts 20, 32, and 150 under one
or more of sections 161b, 161i, or 161o of the AEA. Willful violations
of the rule would be subject to criminal enforcement.
V. Agreement State Compatibility
Under the ``Policy Statement on Adequacy and Compatibility of
[[Page 43654]]
Agreement State Programs'' approved by the Commission on June 30, 1997,
and published in the Federal Register on September 3, 1997 (62 FR
46517), Sec. 20.2207, the proposed rule is classified as Compatibility
Category ``NRC.'' The NRC program elements in this category are those
that relate directly to areas of regulation reserved to the NRC by the
Atomic Energy Act of 1954, as amended (AEA), or the provisions of Title
10 of the Code of Federal Regulations. Although an Agreement State may
not adopt program elements reserved to NRC, it may wish to inform its
licensees of certain requirements via a mechanism that is consistent
with the particular State's administrative procedure laws but does not
confer regulatory authority on the State.
VI. Plain Language
The Presidential Memorandum dated June 1, 1998, entitled, ``Plain
Language in Government Writing'' directed that the Government's writing
be in plain 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
heading ADDRESSES above.
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 nationally
tracked sources 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 establishes 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)(1) for
the proposed changes to part 150 and as described in 10 CFR
51.22(c)(3)(iii) for the changes to parts 20 and 32. 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; NRC Form 748--New.
The title of the information collection: 10 CFR 20, 32, and 150,
``National Source Tracking of Sealed Sources.''
The form number if applicable: NRC Form 748, ``National Source
Tracking Transaction Report.''
How often the collection is required: Initially, at completion of a
transaction, and at inventory reconciliation.
Who will be required or asked to report: Licensees that
manufacture, receive, transfer, or dispose of nationally tracked
sources.
An estimate of the number of annual responses: 4,423 (NRC Form
748--2613 responses; 10 CFR 20--467 responses; 10 CFR 32--10
recordkeepers; 10 CFR 150--1333 responses).
The estimated number of annual respondents: 1,350.
An estimate of the total number of hours needed annually to
complete the requirement or request: 2,662 (NRC Form 748--412 hours [an
average of 10 minutes per response]; 10 CFR 20--467 [1 hour per
response]; 10 CFR 32--450 hours [45 hours per recordkeeper]; 10 CFR
150--1333 hours [1 hour per response]).
Abstract: The NRC is proposing to amend its regulations to
implement a National Source Tracking System for certain sealed sources.
The proposed amendments would require licensees to report certain
transactions involving nationally tracked sources to the National
Source Tracking System. These transactions would include manufacture,
transfer, 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 National Source Tracking
System and 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 National Source Tracking System.
The U.S. Nuclear Regulatory Commission is seeking public comment on
the potential impact of the information collections contained in this
proposed rule on the following issues:
1. Is the proposed information collection necessary for the proper
performance of the functions of the NRC, including whether the
information will have practical utility?
2. Is the estimate of burden accurate?
3. Is there a way to enhance the quality, utility, and clarity of
the information to be collected?
4. How can the burden of the information collection be minimized,
including the use of automated collection techniques?
A copy of the OMB clearance package may be viewed free of charge at
the NRC Public Document Room, One White Flint North, 11555 Rockville
Pike, Room O-1 F21, Rockville, MD 20852. The OMB clearance package and
rule are available at the NRC Worldwide Web site: http://www.nrc.gov/public-involve/doc-comment/omb/index.html for 60 days after the
signature date of this notice and are also available at the NRC
rulemaking Web site, http://ruleforum.llnl.gov.
Send comments on any aspect of these proposed information
collections, including suggestions for reducing the burden and on the
above issues, by August 29, 2005, to the Records and FOIA/Privacy
Services Branch (T-5 F53), U.S. Nuclear Regulatory Commission,
Washington, DC 20555-0001, or by Internet electronic mail to
[email protected] and to the Desk Officer, Office of Information and
Regulatory Affairs, NEOB-10202, (3150-0001, 3150-0014, 3150-0032, and
3150-xxxx), Office of Management and Budget, Washington, DC 20503.
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)
395-3087.
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 largest burden would likely fall on the manufacturers and
distributors of
[[Page 43655]]
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 present value of the costs
of the National Source Tracking System to NRC is estimated to be $21.8
million and to industry is estimated to be $1.7 million in 2005 dollars
using a 3 percent discount rate. These estimated costs include the cost
of development of the system and operation and maintenance thru the
year 2016.
The Commission requests public comment on the draft regulatory
analysis. Comments on the draft analysis may be submitted to the NRC as
indicated under the ADDRESSES heading. The analysis is available for
inspection in the NRC Public Document Room, 11555 Rockville Pike,
Rockville, MD. Single copies of the regulatory analysis are available
from Merri Horn, telephone (301) 415-8126, e-mail, [email protected] of the
Office of Nuclear Material Safety and Safeguards.
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 350 NRC
licensees and an additional 1,000 Agreement State licensees. 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 is estimated to be approximately 15
minutes, depending on the number of sources involved in the transaction
and the method of reporting. This is time needed to complete the
report. 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 on
average 1 hour on the annual reconciliation. The total annual burden to
perform the proposed reporting is approximately 2,662 hours. Based on
the draft regulatory analysis conducted for this action, the costs of
the proposed amendments for affected licensees are estimated to be
$232,000 total or on average about $172 per affected licensee. 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 and common defense
and security. Comments on how the regulation could be modified to take
into account the differing needs of small entities should specifically
discuss--
(a) 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;
(b) How the proposed regulation could be further modified to take
into account the business's differing needs or capabilities;
(c) The benefits that would accrue, or the detriments that would be
avoided, if the proposed regulation was modified as suggested by the
commenter;
(d) 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
(e) How the proposed regulation, as modified, would still
adequately protect the public health and safety and common defense and
security.
Comments should be submitted as indicated under the ADDRESSEES
heading.
XIII. Backfit Analysis
The NRC has determined that the backfit rule (Sec. Sec. 50.109,
70.76, 72.62, or 76.76) does not apply to this proposed rule because
this amendment would not involve any provisions that would impose
backfits as defined in the backfit rule. Therefore, a backfit analysis
is not required.
List of Subjects
10 CFR Part 20
Byproduct material, Criminal penalties, Licensed material, Nuclear
materials, Nuclear power plants and reactors, Occupational safety and
health, Packaging and containers, Radiation protection, Reporting and
recordkeeping requirements, Source material, Special nuclear material,
Waste treatment and disposal.
10 CFR Part 32
Byproduct material, Criminal penalties, Labeling, Nuclear
materials, Radiation protection, Reporting and recordkeeping
requirements.
10 CFR Part 150
Criminal penalties, Hazardous materials transportation,
Intergovernmental relations, Nuclear materials, Reporting and
recordkeeping requirements, Security measures, Source material, Special
nuclear material.
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, 32, and 150.
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, 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).
2. In Sec. 20.1003, a new definition Nationally tracked source is
added in alphabetical order to read as follows:
Sec. 20.1003 Definitions.
* * * * *
Nationally tracked source is a sealed source containing a quantity
equal to or greater than Category 1 or 2 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 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
[[Page 43656]]
Category 2 threshold but less than the Category 1 threshold.
* * * * *
3. In Sec. 20.1009 paragraph (b) is revised and paragraph (c)(6)
is added to read as follows:
Sec. 20.1009 Information collection requirements: OMB approval.
* * * * *
(b) The approved information collection requirements contained in
this part appear in Sec. Sec. 20.1003, 20.1101, 20.1202, 20.1203,
20.1204, 20.1206, 20.1208, 20.1301, 20.1302, 20.1403, 20.1404, 20.1406,
20.1501, 20.1601, 20.1703, 20.1901, 20.1904, 20.1905, 20.1906, 20.2002,
20.2004, 20.2005, 20.2006, 20.2102, 20.2103, 20.2104, 20.2105, 20.2106,
20.2107, 20.2108, 20.2110, 20.2201, 20.2202, 20.2203, 20.2204, 20.2205,
20.2206, 20.2207, 20.2301, and appendix G to this part.
(c) * * *
(6) In Sec. 20.2207, NRC Form 748 is approved under control number
3150-xxxx.
4. Section 20.2207 is added to subpart M to read as follows:
Sec. 20.2207 Reports of transactions involving nationally tracked
sources.
Each licensee who manufactures, transfers, receives, or disposes of
a nationally tracked source shall complete and submit a National Source
Tracking Transaction Report (NRC Form 748) as specified in paragraphs
(a) through (d) of this section for each type of transaction.
(a) Each licensee who manufactures a nationally tracked source
shall complete and submit a National Source Tracking Transaction Report
(NRC Form 748). The report must include the following information:
(1) The name and license number of the reporting licensee;
(2) The name of the individual preparing the report;
(3) The manufacturer, model, and serial number of the source;
(4) The radioactive material in the source;
(5) The initial source strength in becquerels (curies) at the time
of manufacture; and
(6) The manufacture date of the source.
(b) Each licensee that transfers a nationally tracked source to
another person shall complete and submit a National Source Tracking
Transaction Report (NRC Form 748). The report must include the
following information:
(1) The name and license number of the reporting licensee;
(2) The name of the individual preparing the report;
(3) The name and license number of the recipient facility and the
shipping address;
(4) The manufacturer, model, and serial number of the source or, if
not available, other information to uniquely identify the source;
(5) The radioactive material in the source;
(6) The initial or current source strength in becquerels (curies);
(7) The date for which the source strength is reported;
(8) The shipping date;
(9) The estimated arrival date; and
(10) For nationally tracked sources transferred as waste under a
Uniform Low-Level Radioactive Waste Manifest, the waste manifest number
and the container identification of the container with the nationally
tracked source.
(c) Each licensee that receives a nationally tracked source shall
complete and submit a National Source Tracking Transaction Report (NRC
Form 748). The report must include the following information:
(1) The name and license number of the reporting licensee;
(2) The name of the individual preparing the report;
(3) The name and license number of the person that provided the
source;
(4) The manufacturer, model, and serial number of the source or, if
not available, other information to uniquely identify the source;
(5) The radioactive material in the source;
(6) The initial or current source strength in becquerels (curies);
(7) The date for which the source strength is reported;
(8) The date of receipt; and
(9) For material received under a Uniform Low-Level Radioactive
Waste Manifest, the waste manifest number and the container
identification with the nationally tracked source.
(d) Each licensee who disposes of a nationally tracked source shall
complete and submit a National Source Tracking Transaction Report (NRC
Form 748). The report must include the following information:
(1) The name and license number of the reporting licensee;
(2) The name of the individual preparing the report;
(3) The waste manifest number;
(4) The container identification with the nationally tracked
source;
(5) The date of disposal; and
(6) The method of disposal.
(e) The reports discussed in paragraphs (a) through (d) of this
section must be submitted by the close of the next business day after
the transaction. A single report may be submitted for multiple sources
and transactions. The reports must be submitted to the National Source
Tracking System by using:
(1) The on-line National Source Tracking System;
(2) Electronically using a computer-readable format;
(3) By facsimile;
(4) By mail to the address on the National Source Tracking
Transaction Report Form (NRC Form 748); or
(5) By telephone with followup by facsimile or mail.
(f) Each licensee shall correct any error in previously filed
reports or file a new report for any missed transaction within 5
business days of the discovery of the error or missed transaction. Each
licensee shall reconcile and verify the inventory of nationally tracked
sources possessed by the licensee against that licensee's data in the
National Source Tracking System. The verification must be conducted
during the month of June in each year. The reconciliation process must
include resolving any discrepancies between the National Source
Tracking System and the actual inventory by filing the reports
identified by paragraphs (a) through (d) of this section.
(g) 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 December 31,
2006. 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 March 31,
2007. The information may be submitted by using any of the methods
identified by paragraph (e)(1) through (e)(4) of this section. The
initial inventory report must include the following information:
(1) The name 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.
5. In Part 20, new Appendix E is added to read as follows:
Appendix E To Part 20--Nationally Tracked Source Thresholds
The Terabecquerel (TBq) values are the regulatory standard. The
curie (Ci) values
[[Page 43657]]
specified are obtained by converting from the TBq value. The curie
values are provided for practical usefulness only and are rounded
after conversion.
----------------------------------------------------------------------------------------------------------------
Category 1 Category 1 Category 2 Category 2
Radioactive material (TBq) (Ci) (TBq) (Ci)
----------------------------------------------------------------------------------------------------------------
Actinium-227........................................ 20 540 0.2 5.4
Americium-241....................................... 60 1,600 0.6 16
Americium-241/Be.................................... 60 1,600 0.6 16
Californium-252..................................... 20 540 0.2 5.4
Cobalt-60........................................... 30 810 0.3 8.1
Curium-244.......................................... 50 1,400 0.5 14
Cesium-137.......................................... 100 2,700 1 27
Gadolinium-153...................................... 1,000 27,000 10 270
Iridium-192......................................... 80 2,200 0.8 22
Plutonium-236....................................... 60 1,600 0.6 16
Plutonium-238....................................... 60 1,600 0.6 16
Plutonium-239....................................... 60 1,600 0.6 16
Plutonium-239/Be.................................... 60 1,600 0.6 16
Plutonium-240....................................... 60 1,600 0.6 16
Polonium-210........................................ 60 1,600 0.6 16
Promethium-147...................................... 40,000 1,100,000 400 11,000
Selenium-75......................................... 200 5,400 2 54
Strontium-90........................................ 1,000 27,000 10 270
Thorium-228......................................... 20 540 0.2 5.4
Thorium-229......................................... 20 540 0.2 5.4
Thulium-170......................................... 20,000 540,000 200 5,400
Ytterbium-169....................................... 300 8,100 3 81
----------------------------------------------------------------------------------------------------------------
PART 32--SPECIFIC DOMESTIC LICENSES TO MANUFACTURE OR TRANSFER
CERTAIN ITEMS CONTAINING BYPRODUCT MATERIAL
6. The authority citation for part 32 continues to read as follows:
Authority: Secs. 81, 161, 182, 183, 68 Stat. 935, 948, 953, 954,
as amended (42 U.S.C. 2111, 2201, 2232, 2233); sec. 201, 88 Stat.
1242, as amended (42 U.S.C. 5841); sec. 1704, 112 Stat. 2750 (44
U.S.C. 3504 note).
7. In Sec. 32.2, the paragraph designations are removed and a new
definition Nationally tracked source is added in alphabetical order to
read as follows:
Sec. 32.2 Definitions.
* * * * *
Nationally tracked source is a sealed source containing a quantity
equal to or greater than Category 1 or 2 levels of any radioactive
material listed in Appendix E to Part 20 of this Chapter. In this
context a sealed source 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.
8. Section 32.8 paragraph (b) is revised to read as follows:
Sec. 32.8 Information collection requirements: OMB approval.
* * * * *
(b) The approved information collection requirements contained in
this part appear in Sec. Sec. 32.11, 32.12, 32.14, 32.15, 32.16,
32.17, 32.18, 32.19, 32.20, 32.21, 32.21a, 32.22, 32.23, 32.25, 32.26,
32.27, 32.29, 32.51, 32.51a, 32.52, 32.53, 32.54, 32.55, 32.56, 32.57,
32.58, 32.61, 32.62, 32.71, 32.72, 32.74, 32.201, and 32.210.
* * * * *
9. Section 32.201 is added under subpart D to read as follows:
Sec. 32.201 Serialization of nationally tracked sources.
Each licensee who manufactures a nationally tracked source after
[the effective date of final rule] shall assign a unique serial number
to each nationally tracked source. Serial numbers must be composed only
of alpha-numeric characters.
PART 150--EXEMPTIONS AND CONTINUED REGULATORY AUTHORITY IN
AGREEMENT STATES AND IN OFFSHORE WATERS UNDER SECTION 274
10. The authority citation for part 150 continues to read as
follows:
Authority: Sec. 161, 68 Stat. 948, as amended, sec. 274, 73
Stat. 688 (42 U.S.C. 2201, 2021); sec. 201, 88 Stat. 1242, as
amended (42 U.S.C. 5841); sec. 1704, 112 Stat. 2750 (44 U.S.C. 3504
note). Sections 150.3, 150.15, 150.15a, 150.31, 150.32 also issued
under secs. 11e(2), 81, 68 Stat. 923, 935, as amended, secs. 83, 84,
92 Stat. 3033, 3039 (42 U.S.C. 2014e(2), 2111, 2113, 2114). Section
150.14 also issued under sec. 53, 68 Stat. 930, as amended (42
U.S.C. 2073). Section 150.15 also issued under secs. 135, 141, Pub.
L. 97-425, 96 Stat. 2232, 2241 (42 U.S.C. 10155, 10161). Section
150.17a also issued under sec. 122, 68 Stat. 939 (42 U.S.C. 2152).
Section 150.30 also issued under sec. 234, 83 Stat. 444 (42 U.S.C.
2282).
11. In Sec. 150.3, a new definition Nationally tracked source is
added in alphabetical order to read as follows:
Sec. 150.3 Definitions.
* * * * *
Nationally tracked source is a sealed source containing a quantity
equal to or greater than Category 1 or 2 levels of any radioactive
material listed in Appendix E to Part 20 of this Chapter. In this
context a sealed source 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
[[Page 43658]]
than the Category 2 threshold but less than the Category 1 threshold.
* * * * *
12. Section 150.8 paragraph (b) is revised and paragraph (c)(3) is
added to read as follows:
Sec. 150.8 Information collection requirements: OMB approval.
* * * * *
(b) The approved information collection requirements contained in
this part appear in Sec. Sec. 150.16, 150.17, 150.17a, 150.18, 150.19,
150.20, and 150.31.
(c) * * *
(3) In Sec. 150.18, NRC Form 748 is approved under control number
3150-xxxx.
13. In 150.15 paragraph (a)(10) is added to read as follows:
Sec. 150.15 Persons not exempt.
(a) * * *
(10) The assignment of unique serial numbers to each newly
manufactured nationally tracked source as required by Sec. 32.201 of
this chapter.
* * * * *
14. Section 150.18 is added to read as follows:
Sec. 150.18 Submission to Commission of National Source Tracking
Transaction Reports.
Each person who, pursuant to an Agreement State specific license,
manufactures, transfers, receives, or disposes of a nationally tracked
source shall complete and submit a National Source Tracking Transaction
Report (NRC Form 748) as specified in paragraphs (a) through (d) of
this section for each type of transaction.
(a) Each licensee who manufactures a nationally tracked source
shall complete and submit a National Source Tracking Transaction Report
(NRC Form 748). The report must include the following information:
(1) The name and license number of the reporting licensee;
(2) The name of the individual preparing the report;
(3) The manufacturer, model, and serial number of the source;
(4) The radioactive material in the source;
(5) The initial source strength in becquerels (curies) at the time
of manufacture; and
(6) The manufacture date of the source.
(b) Each licensee that transfers a nationally tracked source to
another person shall complete and submit a National Source Tracking
Transaction Report (NRC Form 748). The report must include the
following information:
(1) The name and license number of the reporting licensee;
(2) The name of the individual preparing the report;
(3) The name and license number of the recipient facility and the
shipping address;
(4) The manufacturer, model, and serial number of the source or, if
not available, other information to uniquely identify the source;
(5) The radioactive material in the source;
(6) The initial or current source strength in becquerels (curies);
(7) The date for which the source strength is reported;
(8) The shipping date;
(9) The estimated arrival date; and
(10) For nationally tracked sources transferred as waste under a
Uniform Low-Level Radioactive Waste Manifest, the waste manifest number
and the container identification of the container with the nationally
tracked source.
(c) Each licensee that receives a nationally tracked source shall
complete and submit a National Source Tracking Transaction Report (NRC
Form 748). The report must include the following information:
(1) The name and license number of the reporting licensee;
(2) The name of the individual preparing the report;
(3) The name and license number of the person that provided the
source;
(4) The manufacturer, model, and serial number of the source or, if
not available, other information to uniquely identify the source;
(5) The radioactive material in the source;
(6) The initial or current source strength in becquerels (curies);
(7) The date for which the source strength is reported;
(8) The date of receipt; and
(9) For material received under a Uniform Low-Level Radioactive
Waste Manifest, the waste manifest number and the container
identification with the nationally tracked source.
(d) Each licensee who disposes of a nationally tracked source shall
complete and submit a National Source Tracking Transaction Report (NRC
Form 748). The report must include the following information:
(1) The name and license number of the reporting licensee;
(2) The name of the individual preparing the report;
(3) The waste manifest number;
(4) The container identification with the nationally tracked
source.
(5) The date of disposal; and
(6) The method of disposal.
(e) The reports discussed in paragraphs (a) through (d) of this
section must be submitted by the close of the next business day after
the transaction. A single report may be submitted for multiple sources
and transactions. The reports must be submitted to the National Source
Tracking System by using:
(1) The on-line National Source Tracking System;
(2) Electronically using a computer-readable format;
(3) By facsimile;
(4) By mail to the address on the National Source Tracking
Transaction Report Form (NRC Form 748); or
(5) By telephone with followup by facsimile or mail.
(f) Each licensee shall correct any error in previously filed
reports or file a new report for any missed transaction within 5
business days of the discovery of the error or missed transaction. Each
licensee shall reconcile and verify the inventory of nationally tracked
sources possessed by the licensee against that licensee's data in the
National Source Tracking System. The verification must be conducted
during the month of June in each year. The reconciliation process must
include resolving any discrepancies between the National Source
Tracking System and the actual inventory by filing the reports
identified by paragraphs (a) through (d) of this section.
(g) 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 December 31,
2006. 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 March 31,
2007. The information may be submitted by using any of the methods
identified by paragraph (e)(1) through (e)(4) of this section. The
initial inventory report must include the following information:
(1) The name 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.
Dated in Rockville, Maryland, this 22nd day of July, 2005.
[[Page 43659]]
For the Nuclear Regulatory Commission.
Annette Vietti-Cook,
Secretary of the Commission.
[FR Doc. 05-14919 Filed 7-27-05; 8:45 am]
BILLING CODE 7590-01-P