[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]


 ========================================================================
 Proposed Rules
                                                 Federal Register
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 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.

-----------------------------------------------------------------------

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

[[Page 43648]]

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

[[Page 43649]]

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