[Federal Register Volume 71, Number 216 (Wednesday, November 8, 2006)]
[Rules and Regulations]
[Pages 65686-65709]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-18713]



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Part IV





Nuclear Regulatory Commission





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 10 CFR Parts 20 and 32



National Source Tracking of Sealed Sources; Final Rule

  Federal Register / Vol. 71, No. 216 / Wednesday, November 8, 2006 / 
Rules and Regulations  

[[Page 65686]]


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NUCLEAR REGULATORY COMMISSION

10 CFR Parts 20 and 32

RIN 3150-AH48


National Source Tracking of Sealed Sources

AGENCY: Nuclear Regulatory Commission.

ACTION: Final rule.

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SUMMARY: The Nuclear Regulatory Commission (NRC) is amending its 
regulations to implement a National Source Tracking System for certain 
sealed sources. The amendments require licensees to report certain 
transactions involving these sealed sources to the National Source 
Tracking System. These transactions include manufacture, transfer, 
receipt, disassembly, or disposal of nationally tracked sources. The 
amendments also require each licensee to provide its initial inventory 
of nationally tracked sources to the National Source Tracking System 
and annually reconcile the information in the system with the 
licensee's actual inventory. In addition, the amendments require 
manufacturers to assign a unique serial number to each nationally 
tracked source.

DATES: Effective Date: This final rule is effective on February 6, 
2007.
    Compliance Dates: Compliance with the reporting provisions in 10 
CFR 20.2207 is required by November 15, 2007, for Category 1 sources 
and November 30, 2007, for Category 2 sources.

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 Does This Action Affect?
    D. How Will Information Be Reported to the National Source 
Tracking System?
    E. Will a Licensee Need To Report Its Current Inventory to the 
System?
    F. What Information Will Be Collected on Source Origin?
    G. What Information Will Be Collected on Source Transfer?
    H. What Information Will Be Reported for Receipt of Sources?
    I. What Information Will Be Reported on Source Endpoints?
    J. How Will the National Source Tracking System Information Be 
Kept Current?
    K. How Will 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. Will This Rule 
Result in a Duplication in Reporting?
    M. Are the Actions Consistent With International Obligations?
    N. When Do These Actions Become Effective?
    O. Who Will Have Access to the Information and What Will It Be 
Used For?
    P. What Other Things Are Required by This Action?
III. Analysis of Public Comments on the Proposed Rule
IV. Section by Section Analysis of Substantive Changes
V. Criminal Penalties
VI. Agreement State Compatibility
VII. Voluntary Consensus Standards
VIII. Environmental Impact: Categorical Exclusion
IX. Paperwork Reduction Act Statement
X. Regulatory Analysis
XI. Regulatory Flexibility Certification
XII. Backfit Analysis
XIII. Congressional Review Act

I. Background

    After the terrorist attacks in the United States on September 11, 
2001, the NRC conducted a comprehensive review of nuclear material 
security requirements, with particular focus on radioactive material of 
concern. This radioactive material (which includes Cobalt-60, Cesium-
137, Iridium-192 (Ir-192), and Americium-241, as well as other 
radionuclides) has the potential to be used in a radiological dispersal 
device (RDD) or a radiological exposure device (RED) in the absence of 
proper security and control measures. The NRC's review took into 
consideration the changing domestic and international threat 
environments and related U.S. Government-supported international 
initiatives in the nuclear security area, particularly activities 
conducted by the International Atomic Energy Agency (IAEA).
    In June 2002, the Secretary of Energy and the NRC Chairman met to 
discuss the adequate protection of inventories of nuclear materials 
that could be used in a RDD. At the June meeting, the Secretary of 
Energy and the NRC Chairman agreed to convene an Interagency Working 
Group on Radiological Dispersal Devices to address security concerns. 
In May 2003, the joint U.S. Department of Energy (DOE)/NRC report was 
issued. The report was entitled, ``Radiological Dispersal Devices: An 
Initial Study to Identify Radioactive Materials of Greatest Concern and 
Approaches to Their Tracking, Tagging, and Disposition.'' One of the 
report's recommendations is development of a national source tracking 
system to better understand and monitor the location 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 of the report, 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. In particular, the Code of Conduct contains a 
recommendation that each IAEA Member State develop a national source 
registry of radioactive sources that includes at a minimum Category 1 
and Category 2 radioactive sources as described in Annex 1 of the Code 
of Conduct. The source registry recommendation addressed 16 
radionuclides.
    The work on the DOE/NRC joint report was done in parallel with the 
work on the Code of Conduct and the development of IAEA TECDOC-1344, 
``Categorization of Radioactive Sources.'' The IAEA published this 
categorization system for radioactive sources in August 2005 in its 
Safety Series as RS-G-1.9, Categorization of Radioactive Sources. The 
report, available on the IAEA Web site, provides the underlying 
methodology for the development of the Code of Conduct thresholds. The 
categorization system is based on the potential for sources to cause 
deterministic effects and uses the `D' values as normalizing factors. 
The `D' values are radionuclide-specific activity levels for the 
purposes of emergency planning and response. The quantities of concern 
identified in the DOE/NRC report are similar to the Code of Conduct 
Category 2 threshold values, so to allow alignment between domestic and 
international efforts to increase the safety and security of 
radioactive sources, NRC has adopted the Category 2 values.
    The 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

[[Page 65687]]

has endorsed the Code of Conduct and is working toward implementation 
of its various provisions. This rulemaking reflects those Code of 
Conduct recommendations related to the source registry and which are 
consistent with NRC responsibilities under the Atomic Energy Act.
    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 by academic, government, and private institutions. These 
materials are as diverse in geographical location as they are in 
functional use.
    NRC considers national source tracking to be part of a 
comprehensive radioactive source control program for radioactive 
materials of greatest concern. Although a national source tracking 
system can not ensure the physical protection of sources, it can 
provide greater source accountability, which should 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 and control for radioactive sources. 
It will also result in improved public health and safety.
    To 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 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. DOE will have greater access as 
they will be responsible for entering data on sources entering or 
exiting the DOE complex.
    Development of the National Source Tracking System is a two-part 
activity that includes both a rulemaking and an information technology 
development component. When completely operational, the National Source 
Tracking System will be a Web-based system that will allow licensees to 
meet the proposed reporting requirements on-line. The system will 
contain information on NRC licensees, Agreement State licensees, and 
the DOE complex as appropriate.
    This final rulemaking establishes the regulatory foundation for the 
National Source Tracking System recommended in the DOE/NRC report and 
expands on implementation of the Code of Conduct recommendation to 
develop a national source registry.
    There is clearly broad U.S. Government and international interest 
in tracking radioactive sources to improve accountability and control. 
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 
these systems do not record actual sources or their movements.
    To address this lack of information on such issues as actual 
material possessed, the NRC, in cooperation with 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 was 
updated in 2005 and will continue to be updated until the National 
Source Tracking System is operational. The interim database 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.
    The President signed the Energy Policy Act of 2005 into law on 
August 8, 2005. It contains a provision on national source tracking 
that requires the NRC to issue regulations establishing a mandatory 
tracking system for radiation sources in the United States. The 
regulations must be issued no later than one year after the date of 
enactment of the Act. The Act requires the tracking system to: (1) 
Enable the identification of each radiation source by serial number or 
other unique identifier; (2) require reporting within 7 days of any 
change of possession of a radiation source; (3) require reporting 
within 24 hours of any loss of control of, or accountability for, a 
radiation source; and (4) provide for reporting through a secure 
internet connection. The Act further requires the NRC to coordinate 
with the Secretary of Transportation to ensure compatibility, to the 
maximum extent practicable, between the tracking system and any system 
established by the Secretary of Transportation to track the shipment of 
radiation sources. Under the Act, radiation source means a Category 1 
source or a Category 2 source as defined in the Code of Conduct and any 
other material that poses a threat, as determined by the Commission, by 
regulation, other than spent nuclear fuel and special nuclear material.
    This final rule on National Source Tracking meets the requirements 
enumerated above, which were applicable to source tracking and imposed 
by the Energy Policy Act of 2005. The rule requires the reporting of 
transfers and receipts of sources by the close of the next business 
day, which meets the requirement for reporting within 7 days of any 
change of possession. The information to be reported includes the 
serial number of the source, which addresses identification of each 
source by serial number. On-line reporting is one of the methods by 
which licensees may report; this meets the requirement to allow 
reporting through a secure internet connection. Current NRC and 
Agreement State regulations require licensees to immediately report, 
after its occurrence becomes known to the licensee, any lost, stolen, 
or missing licensed material at the Category 1 or 2 level. Therefore, 
this final rule does not include provisions for reporting loss of 
control of, or accountability for, a radiation source.

II. Discussion

A. What Action Is the NRC Taking?

    The NRC is issuing a rule that implements a new program called the 
National Source Tracking System. The final rule requires licensees to 
report information on the manufacture, transfer, receipt, disassembly, 
and disposal of nationally tracked sources. This information captures 
the origin of each nationally tracked source (manufacture or import), 
all transfers to other licensees, all receipts of nationally

[[Page 65688]]

tracked sources, and endpoints of each nationally tracked source 
(disassembly, disposal, decay, or export). Ultimately, the National 
Source Tracking System will be able to provide a domestic life history 
account of all nationally tracked sources.
    A system of this type needs prompt updating to be useful and 
accurate. In order to capture information as soon as possible, this 
rule requires licensees to report information on nationally tracked 
source transactions by the close of the next business day. Although the 
Energy Policy Act of 2005 provides for reporting within 7 days, the 
rule requires reporting by the close of the next business day. After 
discussions within the Interagency Coordinating Committee, NRC 
determined that 7 days was too long a time period. NRC has determined 
that the close of the next business day is the appropriate timeframe 
for reporting.
    To ease the burden on licensees, the NRC is establishing a secure 
Internet-based interface to the National Source Tracking System. While 
on-line access should be fast, accurate, and convenient for licensees, 
the NRC will also allow licensees the option of completing and mailing 
or faxing paper forms. In addition, licensees will 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 sealed in 
a capsule or is 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 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 is not 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. The definition of nationally tracked source 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 Appendix E to part 20. The radionuclides and thresholds 
of 16 of the radionuclides are identical to the Table I values from the 
Code of Conduct. The IAEA Code of Conduct includes a recommendation 
that these radionuclides 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 Energy Policy Act of 2005 states 
that Category 1 and Category 2 sources are to be included in the 
National Source Tracking System.
    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 Ci values are not 
intended to be the regulatory standard.
    Table I of the IAEA Code of Conduct lists 16 radionuclides that 
should be included in a national source registry. Included in this 
listing is radium (Ra)-226. Before the Energy Policy Act of 2005 was 
signed into law, the NRC did not have the authority to regulate Ra-226; 
therefore it was not included in the proposed rule for national source 
tracking. Section 651(e) of the Energy Policy Act of 2005 amends 
section 11e. of the Atomic Energy Act to give NRC authority over 
discrete sources of Ra-226 and other radioactive materials if they are 
produced, extracted, or converted after extraction for use in 
commercial, medical, or research activities. Therefore, NRC is adding 
Ra-226 to Appendix E in this final rule. Ra-226 sealed sources will now 
be included in the National Source Tracking System. The term `discrete 
source' will be defined in a separate rulemaking to implement section 
651(e) of the Energy Policy Act of 2005. That final rule is to be 
issued by February 7, 2007.
    In the proposed rule, the Commission expanded the National Source 
Tracking System list of radionuclides to include 6 radionuclides that 
are not on the Code of Conduct list and one radionuclide that is listed 
in the Code of Conduct but is not included in the source registry 
recommendation. The 7 additional radionuclides included in the proposed 
rule were actinium (Ac)-227, plutonium (Pu)-236, Pu-239, Pu-240, 
polonium-210, thorium (Th)-228, and Th-229. The DOE/NRC RDD report 
recommendation for a National Source Tracking System included these 7 
radionuclides. The thresholds for these radionuclides were developed 
using the same methodology as those listed in the Code of Conduct. 
These radionuclides are also 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 radionuclides. DOE, however, is more likely to possess 
these isotopes, and therefore, it was determined that these isotopes 
should be included in the National Source Tracking System. Therefore, 
the Commission included them in the proposed rule. The source tracking 
system NRC is required to establish under the Energy Policy Act of 2005 
covers ``radiation sources'' as defined in the Act (Category 1 and 
Category 2 sources and any other material as determined by the 
Commission other than spent nuclear fuel and special nuclear 
materials). Three plutonium (Pu) isotopes (Pu-236, Pu-239, Pu-240) are 
being removed from Appendix E because these isotopes are not 
``radiation sources'' within the meaning of the Act. Two other Pu 
isotopes (Pu-238 and Pu-239/Be) are being retained in Appendix E 
because they are listed in the Code of Conduct.

C. Who Does This Action Affect?

    The final rule applies to any person (entity or individual) in 
possession of a Category 1 or Category 2 source. It applies to all NRC 
licensees; including, for example:
    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

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    Disposal facilities and waste brokers.
    Agreement States will impose legally binding requirements on their 
licensees such that all licensees, both NRC and Agreement State, will 
begin reporting at the same time.
    The final rule applies 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 Will Information Be Reported to the National Source Tracking 
System?

    Licensees have several options for reporting transaction 
information to the National Source Tracking System. These reporting 
methods 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 (e.g. 
through the Internet). To report information on-line, a licensee will 
need to establish an account with the National Source Tracking System. 
Once an account is established, the licensee will be provided with 
access to the on-line system. A licensee will have access only to 
information regarding its own material or facility; a licensee will not 
have access to information concerning other licensees or facilities. 
When logged on, the licensee will be able to type the necessary 
information onto the on-line forms. Once a source is in the system, the 
licensee will be able to click on the source and report a transfer or 
other transaction. Identifying information such as license number, 
facility name, address, manufacturer, model number, serial number, etc. 
will not need to be typed in a second time.
    Many licensees conduct a large number of transactions, especially 
manufacturing and distribution licensees. We recognize that most 
licensees have a system for maintaining their information on sources. 
The National Source Tracking System will be able to accept batch load 
information from licensees systems using a computer-readable format. 
This will ease the reporting burden for a licensee with a large number 
of transactions. The licensee will be able to electronically send a 
batch load using a computer-readable format file that contains all of 
the transactions that occurred that day. Licensees can also use this 
format to report their initial inventory.
    Licensees will 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 will be able to provide 
transaction information by telephone and then follow-up with a paper 
copy.
    Additional guidance on submitting information will be provided 
before the effective date of the reporting requirements. The guidance 
will 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. The NRC 
plans to hold several workshops on reporting information to the 
National Source Tracking System which will include hands-on training. 
The workshops will be held before the effective date of the reporting 
requirements. Licensees (both NRC and Agreement State) will receive 
information on when and where the workshops will be held.

E. Will a Licensee Need to Report Its Current Inventory to The System?

    Yes, licensees are required to report their current inventory of 
nationally tracked sources by a specified date. There are separate 
reporting dates for Category 1 and Category 2 nationally tracked 
sources. Licensees are required to report all Category 1 sources to the 
National Source Tracking System by November 15, 2007, and all Category 
2 sources by November 30, 2007.
    To ease the reporting process, information already in the interim 
database will be downloaded to the National Source Tracking System. 
Each licensee that reported information to the interim database will be 
provided a 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 initial inventory information is correct. 
Licensees that did not provide information to the interim database must 
provide the information on their nationally tracked source inventory by 
the specified dates. Disposal facilities do not need to report sources 
that have already been buried or otherwise disposed.
    For sources that are stored in a device, the licensee must report 
the serial number of the source within the device. Licensees are not 
required to report the device number. Sources are usually not placed 
permanently in the device, but are removed from the device at the end 
of the source's useful life. Because some licensees track their sources 
by device number, the National Source Tracking System contains an 
optional reporting field for reporting the device serial number. 
Licensees will be able to search their data by device number. For 
licensees reporting by the paper form, the device number can be added 
to the comment field.

F. What Information Will Be Collected on Source Origin?

    Each time a nationally tracked source is manufactured in the United 
States, the licensee must 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 must 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, address, and the name 
of the individual that prepared the report. Manufacturers may make one 
report that includes both the manufacture and transfer of sources, as 
long as the transfer occurs within the reporting timeframe of the 
manufacture. The information required for both transactions will need 
to be included in 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 must 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 is considered the source origin 
unless the source had been previously possessed in the United States. 
The licensee must report the manufacturer (make), model number, serial 
number, radioactive material,

[[Page 65690]]

activity at manufacture or import, and manufacture or import date for 
each source. The licensee must also provide its license number, 
facility name, address, and the name of the individual that prepared 
the report and the date of receipt. The licensee must also 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, licensees are required to notify the NRC of imports of 
radioactive material at Category 2 levels or above (70 FR 37985; July 
1, 2005). This notification includes source identification information, 
if available. Initially, NRC staff will enter the notification 
information into the National Source Tracking System, but eventually, 
import/export licensees will be able to make the notifications to the 
NRC using the on-line reporting mechanism of the National Source 
Tracking System. For example, if the notification includes the detailed 
source information, a licensee that is receiving an imported nationally 
tracked source will be able to report the transaction as a simple 
receipt using the on-line method. Much of the source information will 
already be in the National Source Tracking System; the licensee will 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 Will Be Collected on Source Transfer?

    Each time a nationally tracked source is transferred to another 
authorized facility, the licensee must 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), address, 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 is reported 
for the recipient's license number. The licensee also must provide its 
name, address, and license number, as well as the name of the 
individual making the report. For nationally tracked sources that are 
transferred as waste under a Uniform Low-level Radioactive Waste 
Manifest, the licensee must also report the waste manifest number and 
the container identification number for the container with the 
nationally tracked source.
    Source transfer transactions are transfers between different 
licensees and transfers from a licensee to another authorized facility, 
such as a DOE site or a foreign entity. A source transfer transaction 
does not include transfers to a temporary domestic job site. Domestic 
transactions in which the nationally tracked source remains in the 
possession of the licensee do not require a report to the National 
Source Tracking System. For example, a radiographer conducting business 
does 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.

H. What Information Will Be Reported for Receipt of Sources?

    A licensee must 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, address, and license number and the 
name of the individual that prepared the report. The licensee must also 
provide the name, address, 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 must report the 
source activity and associated activity date. The import license number 
is 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. To avoid 
unnecessary exposure, these licensees are not expected to open the 
waste container to verify the presence of the nationally tracked 
source; they may rely on the information from the licensee who shipped 
the source.

I. What Information Will Be Reported on Source Endpoints?

    Endpoints for a source include export, disassembly, disposal, 
decay, loss or theft, and destruction of the source. Some of the 
endpoints are reversible (export, loss, theft) and some are permanent 
(disassembly, disposal, destruction). Exports are 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 is reported 
as the license number of the receiving facility.
    Some licensees disassemble sources for possible recycle. The source 
is taken apart, the radioactive material is removed, and the material 
may be used for manufacture of new sources or sent for disposal. This 
is not the same as reconfiguration where the source is not destroyed. 
The licensee must report the disassembly of any nationally tracked 
source to the National Source Tracking System by the close of the next 
business day. Once a source has been disassembled, it is no longer 
tracked. This is a permanent endpoint. Licensees that report a 
disassembly transaction must include the source information 
(manufacturer, model number, serial number, and radioactive material), 
license information (name, address, license number, name of person 
making the report), and the date of the disassembly.
    Disposal of a source is 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 treat the transaction as a transfer. The licensee 
must include the waste manifest number and the container identification 
number. The disposal facility is not expected to open the waste 
container to verify the contents, and may report the information from 
the licensee who sent the waste for disposal. 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 who prepared the 
report. The report must be made by the close of the next business day.
    The National Source Tracking System automatically calculates the 
decay of a source so licensees do not need to report an endpoint of 
decay. Once a source has decayed below Category 2 levels, it is no 
longer considered to be a nationally tracked source. The source will be 
automatically removed from a licensee's active inventory in the 
National Source Tracking System. The licensee will receive a 
notification that the source has decayed below the tracking level and 
that transactions for this source no longer need to be reported. The 
data on the source will, however, be retained in the system.
    Licensees must continue to report accidental destruction of sources 
to the NRC Operations Center or to their Agreement State. The Agreement 
States

[[Page 65691]]

provide the information to the NRC Operations Center. NRC staff will 
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. An example of accidental destruction 
includes sources destroyed during attempts to remove them from devices.
    Other endpoints that will be captured by the National Source 
Tracking System include the loss or theft of a source or the 
abandonment of a source in a well. These events are already reported to 
either NRC or to the Agreement States. Licensees are not required to 
report this information a second time to the National Source Tracking 
System. Agreement State licensees must continue to report to their 
Agreement State. NRC staff will 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. Agreement 
State staff may also enter the information into the system. Loss and 
theft of a source are considered to be reversible endpoints and source 
abandonment in a well is considered a permanent endpoint.

J. How Will the National Source Tracking System Information Be Kept 
Current?

    Data integrity for the National Source Tracking System is extremely 
important. Licensees are expected to provide correct information to the 
National Source Tracking System and to double-check the accuracy of 
their information before submission. However, to maintain the accuracy, 
currency, and reliability of the National Source Tracking database, 
licensees are required by this rule to correct any mistakes in their 
inventory information and annually verify the accuracy of their data.
    If licensees accurately report their transactions in a timely 
manner, the National Source Tracking System will 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. 
Discrepancies might result from the failure to report the receipt of a 
source or failure to report the transfer of a source to another 
licensee. Inaccuracies can result from errors in the initial inventory 
report, selection of the wrong model number, or incorrectly typing the 
serial number. Each licensee is required to correct any errors or 
missed transactions that it becomes aware of within 5 business days of 
the discovery.
    In addition, each licensee is required to reconcile its on-site 
inventory of nationally tracked sources with the information previously 
reported to the National Source Tracking System. This reconciliation 
occurs during the month of January each year. Each licensee will be 
able to print a copy of its inventory information from the National 
Source Tracking System. Licensees without on-line access will receive a 
paper copy from the NRC of their information in the National Source 
Tracking System. Each licensee must compare the information contained 
in the system to its own inventory, including a check of the model and 
serial number of each source. This reconciliation does not require the 
licensee to conduct an additional physical inventory of its sources. 
The NRC's regulations already require licensees to conduct physical 
inventories either annually, semi-annually, or quarterly, depending on 
the type of license. Each licensee must reconcile any differences by 
reporting the appropriate transaction(s) or corrections to the National 
Source Tracking System. The reconciliation must be completed by January 
31 of each year.
    In addition, each licensee must report to the National Source 
Tracking System that their data in the National Source Tracking System 
is correct. Licensees reporting their reconciliation using non-
electronic methods will have to use a hard copy form, which will be 
provided with the paper copy of the information contained in the 
National Source Tracking System. The first reconciliation will occur in 
January 2008.

K. How Will Incorrect Information Be Changed in the National Source 
Tracking System?

    Licensees will be able to correct errors in the National Source 
Tracking System at any time, either online or through any other 
permitted reporting mechanism. Each licensee is responsible for 
correcting any errors in its inventory information in the National 
Source Tracking System, regardless of the source of the error, within 5 
business days of the discovery.

L. Some Licensees Now Must Report Similar Information to the Nuclear 
Materials Management Safeguards System. Will This Rule Result in a 
Duplication in Reporting?

    Yes, some information on plutonium (Pu) and thorium (Th) is 
collected by both the Nuclear Materials Management Safeguards System 
(NMMSS) and the National Source Tracking System. The current 
regulations require reporting transfers, receipts, and inventories to 
NMMSS of one gram or more of Pu and any Th 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 cannot be extracted from NMMSS to provide input into 
the National Source Tracking System. The National Source Tracking 
System will only have information on sealed sources and will 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, NRC will not be able to 
extract information from the National Source Tracking System to support 
NMMSS. Neither system is able to collect the needed information for the 
other system without modifications to the databases and additional 
changes to the regulations. The two systems also have different 
purposes.
    In practice, NRC finds that these Pu and Th sources are typically 
held by licensees for long time periods and are not routinely 
transferred to other licensees, so incidences of double-reporting are 
expected to be rare. Only 10 licensees reported possessing Pu Category 
1 or Category 2 sources and no licensee reported Th sources to the 
interim database. The NRC does not believe that the limited number of 
licensees and transactions likely to be affected by this dual reporting 
requirement imposes an unnecessary burden. The NMMSS and the National 
Source Tracking System collect information on these radionuclides 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 Actions Consistent With International Obligations?

    Yes, the National Source Tracking System is 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. In addition, attendance at international 
meetings provides the NRC staff with information on the actions of 
other countries to implement Code of Conduct recommendations. To the 
extent feasible, NRC will utilize data formats compatible with those of 
other countries.

[[Page 65692]]

N. When Do These Actions Become Effective?

    The requirements for Category 1 nationally tracked sources will be 
implemented by November 15, 2007. This means that by this date any 
licensee that possesses a Category 1 level source must have reported 
its initial inventory and must begin reporting all transactions 
involving Category 1 sources to the National Source Tracking System. 
The requirements for Category 2 nationally tracked sources will be 
implemented by November 30, 2007. By this date, all licensees must have 
reported their initial inventory of nationally tracked sources and 
begin reporting all transactions to the National Source Tracking 
System. For all other provisions, the final rule is effective 90 days 
after publication in the Federal Register.

O. Who Will Have Access to the Information and What Will It Be Used 
For?

    Information in the National Source Tracking System is considered 
Official Use Only--Security-Related Information; the information is not 
considered to be Safeguards Information or Safeguards Information--
Modified Handling. A licensee will be able to view its own data, but 
not data for other licensees. NRC, as the database manager, will have 
access to all of the information. Agreement State staff will be able to 
view information on the licensees in their State, but will 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 
will be able to view the information on lost or stolen sources for 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.
    The National Source Tracking System will 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 Are Required by This Action?

    The final rule also requires 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.

III. Analysis of Public Comments on the Proposed Rule

    The proposed rule on National Source Tracking was published on July 
28, 2005 (70 FR 43646). The comment period ended on October 11, 2005. 
The NRC received 33 comment letters on the proposed rule. The NRC also 
held two public meetings on the proposed rule during the comment 
period. The first meeting was held in Rockville, Maryland on August 29, 
2005, and the second meeting was held in Houston, Texas on September 
20, 2005. Approximately 90 people attended the two meetings, with 17 
individuals providing comments. The overall commenter mix on the 
proposed rule included federal agencies, states, licensees, industry 
organizations, and individuals. Copies of the public comments and the 
public meeting transcripts are available for review in the NRC Public 
Document Room, 11555 Rockville Pike, Rockville, MD or on the NRC's 
rulemaking Web site located at http://ruleforum.llnl.gov. NRC also 
invited comment on the basis change of the rule from common defense and 
security to public health and safety. The notice inviting comment on 
the basis change was published June 13, 2006 (71 FR 34024) for a 20-day 
public comment period. The comment period was extended to July 28, 2006 
(71 FR 37862; July 3, 2006). Fourteen comment letters were received on 
the basis change. In addition, a letter from two members of Congress 
was placed in the rule docket. Comments on the basis change and the 
associated responses are addressed in Comments G.12-G.19.
    The comments and responses have been grouped into 12 areas. NRC 
specifically sought comments on the first six areas: (1) Inclusion of 
Category 3 Sources; (2) inclusion of Ra-226; (3) inclusion of transfers 
between temporary job sites; (4) inspection of waste shipments; (5) 
data quality assurance; and (6) data protection. The other six comment 
areas are: (1) General; (2) rule language; (3) regulatory analysis; (4) 
implementation; (5) system aspects; and (6) miscellaneous. To the 
extent possible, all of the comments on a particular subject are 
grouped together. A discussion of the comments and the NRC staff's 
responses follow.

A. Category 3 Sources

    In the proposed rule, NRC specifically invited comment on whether 
Category 3 sources should be included in the National Source Tracking 
System. Category 3 sources are those containing a quantity equal to or 
greater than the Category 3 threshold (\1/10\th of the Category 2 
threshold) but less than the Category 2 threshold. Although the NRC did 
not plan to include Category 3 sources in this rulemaking, Category 3 
sources could be included in the National Source Tracking System in the 
future. The potential issue was that a licensee possessing a large 
number of Category 3 sources could present a security concern. 
Therefore, NRC sought information on the number of additional licensees 
that would be impacted, the number of Category 3 sources possessed by 
licensees, and how often those sources changed hands.
    Twenty-four commenters addressed the issue of Category 3 sources, 
including three Agreement States. The majority of commenters on this 
issue were opposed to including Category 3 sources in the National 
Source Tracking System; only six commenters supported the inclusion, 
including two Agreement States and one non-Agreement State. Reasons for 
inclusion varied. According to one commenter, the higher activity 
Category 3 sources may pose a threat nearly comparable to the threat 
posed by Category 2 sources and should be tracked aggressively. Some 
commenters thought that Category 3 sources should be included because 
an accumulation of sources could possibly threaten national security. 
Others stated that any level of any radioactive material used in an RDD 
or RED would cause panic among the population. One commenter noted that 
the IAEA has indicated that Category 3 sources carry a potential risk 
of harm that warrants inclusion in a tracking system, but Member States 
did not want to include the Category 3 sources in the national registry 
recommendation because the large number of such sources and the 
economic cost for tracking them could be overly burdensome. The 
commenter stated that Category 3 sources should be included unless it 
can be shown that to do so is unreasonably burdensome (due to the large 
number of sources and the economic cost of tracking them). The 
commenter noted that, by IAEA definition, Category 3 sources are 
dangerous and could result in permanent injury, as well as cause 
serious social and economic impact, if not managed or securely 
protected.

[[Page 65693]]

    Commenters argued that the Category 3 sources should be tracked to 
help prevent their possible entry into the scrap metal industry, 
pointing out that the Category 3 sources were more likely to be 
introduced into the recycle stream. Commenters stated that the Category 
3 sources present a danger to the metals-recycling industry, its 
employees, and their communities. Two commenters provided data on 
clean-up costs for contaminated steel mills. Commenters stated that 
public health and safety concerns, as well as security concerns, 
support the inclusion of Category 3 sources at this time. One commenter 
stated that with modest additional investment, NRC has the ability to 
track Category 3 sources and that the failure to do so will foreclose 
an opportunity to advance a rule which would be truly protective of 
public safety and the environment. Another commenter stated that 
additional data needs to be collected on the inclusion of Category 3 
sources, but noted that any study should not be done in such a way that 
would disrupt the current implementation schedule for Category 1 and 
Category 2 source tracking. One commenter argued that the data from the 
inclusion of Category 3 sources would enable the government to more 
effectively manage the protection of the public health and safety and 
the economic vitality of the United States scrap metal industry and 
that the data could be used to monitor market trends, establish 
projections for low-level waste disposal, and allocate resources for 
programs to identify and develop alternate technologies.
    Most of the commenters opposed to the inclusion of Category 3 
sources cited the increased burden that would be imposed on licensees 
and the NRC. One commenter noted that the inclusion of Category 3 
sources would require over 7,000 additional transaction reports every 
year for his company; most commenters did not provide specific numbers, 
but indicated that there would be a significant increase in the 
transaction reports from thousands to tens of thousands.
    According to one commenter, inclusion of Category 3 sources would 
significantly increase the number of impacted licensees and all medical 
facilities that perform radiation therapy procedures would be impacted. 
One commenter noted that most of the sources are used in teletherapy or 
gamma sterotactic radiosurgery units and that once the sources are 
placed in the machines, tampering or stealing the sources becomes very 
difficult. A couple of commenters pointed out that many of these 
sources are used extensively in generally licensed gauges at fixed 
facilities and that most of the individuals possessing these materials 
do not even realize that they have an NRC or Agreement State license. 
The commenters felt that these individuals would be unlikely to 
understand the tracking system and would need additional education to 
understand their responsibilities under the tracking system. Commenters 
stated that including Category 3 sources in the tracking system would 
unduly burden manufacturers and licensees due to the large number of 
Category 3 sources that are in common use throughout the United States. 
Other commenters pointed out that licensees are required to maintain 
inventory records and that this should be sufficient. Some of the 
commenters suggested inventory reporting instead of source 
transactions.
    Commenters pointed out that many of the Category 3 sources are 
lower risk and do not pose a significant terrorist threat in comparison 
to Category 1 and 2 sources. One commenter stated that including 
Category 3 sources would go beyond the IAEA Code of Conduct 
recommendation and that to maintain consistency with the Code of 
Conduct, NRC should not include Category 3 sources. One commenter 
opposed the inclusion of Category 3 sources now and in the future 
because implementing standards more stringent than the IAEA code of 
conduct will generate confusion and not integrate the United States 
plan with international efforts in this regard. One Agreement State 
stated that inclusion of Category 3 sources does not fall within the 
security requirements and should not be included. The State noted that 
if a licensee possessed enough sources in the aggregate it would be 
under increased security control requirements.
    Several commenters expressed concern that inclusion of Category 3 
sources would bog down the system development process, hinder the 
timely implementation of the system, and potentially degrade the 
quality of the information in the database. Commenters noted that there 
will be a breaking-in period while both the regulated and regulators 
learn to complete, report, and maintain the necessary reports. 
Commenters noted that inclusion of Category 3 sources would 
dramatically increase the number of records and would diminish the 
effectiveness of the rule (by increasing the likelihood of data entry 
error, impacting timeliness, and through sheer volume). Several 
commenters noted that the issue could be revisited after the National 
Source Tracking System has been implemented and is running smoothly. 
Two commenters suggested that before including Category 3 sources, the 
NRC should conduct a roundtable discussion with stakeholders to fully 
understand the impact of the rulemaking on the medical community and to 
ensure that final regulations do not impose unintended problems in the 
practice of medicine.
    Response: As part of the proposed rulemaking on the National Source 
Tracking System, NRC requested the views of potentially impacted 
stakeholders on the inclusion of Category 3 sources in the National 
Source Tracking System. The comments received expressed strong views on 
this topic. At this point NRC staff does not have adequate information 
to support inclusion of Category 3 sources. There are also issues 
related to possession of Category 3 sources under a general license 
that need to be addressed before a final decision can be made. In 
addition, the Radiation Source Protection and Security Task Force, 
established by the Energy Policy Act of 2005, reviewed the National 
Source Tracking System and suggested that the issue of including 
Category 3 sources in the system should be evaluated and a final 
decision made on the issue.
    In this rulemaking, the Commission is not making a final 
determination on what additional sources should be included in the 
National Source Tracking System. This rulemaking addresses Category 1 
and 2 sources on the date this rule becomes effective. If additional 
material is added to the National Source Tracking System, it will be 
done through subsequent rulemaking. In a June 9, 2006, Staff 
Requirements Memorandum, the Commission has directed the NRC staff to 
conduct a one-time survey of Category 3.5 sources (one-tenth of 
Category 3) and develop a proposed rule to include Category 3 data in 
the National Source Tracking System.

B. Ra-226

    At the time the proposed rule was published, NRC did not have 
authority over Ra-226. Because the IAEA Code of Conduct included Ra-226 
in its recommendation for a source registry, NRC specifically invited 
comment on whether States would be willing to develop regulations that 
would require their licensees to report Ra-226 to either the State or 
to the National Source Tracking System. NRC received input from six 
commenters, including four States. The commenters all supported the 
inclusion of Ra-226 in the tracking system.
    The Energy Policy Act of 2005 brought discrete sources of Ra-226 
that are produced, extracted, or converted

[[Page 65694]]

after extraction, for use in a medical, research, or commercial 
activity, under the regulatory authority of the NRC. Because the NRC 
now has authority over Ra-226 sealed sources, Ra-226 has been added to 
Appendix E in this final rule. The NRC is currently developing a 
rulemaking that will, among other things, define discrete sources of 
Ra-226. NRC intends to issue final regulations by February 7, 2007, 
which will provide licensees adequate time to become familiar with new 
Ra-226 requirements before the implementation of the National Source 
Tracking System.

C. Temporary Job Sites

    As drafted, the proposed rule only covered source transfers between 
different licensees and/or authorized facilities such as a DOE site or 
an export. It did not include transfer to a temporary job site. 
Therefore, transactions in which the nationally tracked source remained 
in the possession of the licensee would not have required a report to 
the National Source Tracking System. NRC specifically invited comment 
on whether licensees should be required to report as a transaction the 
use of a nationally tracked source at temporary job sites, whether in 
the same State or a different State, and if temporary job site 
transactions were included in the System, how much additional burden 
would be involved and what the reporting timeframe should be. Twenty-
four commenters addressed this issue, including two Agreement States. 
The overwhelming majority of commenters were opposed to reporting 
transactions for source use at temporary job sites. One State supported 
the inclusion of transfers to temporary job sites arguing that security 
at temporary job sites could easily be compromised and reporting would 
provide information on what sources are on the state highways. Two 
Agreement States stated that while reporting use at temporary job sites 
would be useful, it should only be required when licensees perform 
temporary jobs across State lines. The information could then be 
compared to existing reciprocity reports if the host State was allowed 
access to the necessary information. The commenters stated that host 
States should be allowed access to the data to confirm what sources are 
within their borders.
    Commenters opposed to the inclusion of reporting transactions at 
temporary job sites indicated that this would impose a large burden, 
the information reported would not add any value, and in fact would be 
out of date by the time it was reported. Commenters stated that many 
licensees can work at several job sites per day, noting that crews 
could conceivably go to eight different jobs each day. The commenters 
stated that reporting these movements would not add anything to the 
physical security of the sources, a point the NRC acknowledged in the 
Statement of Considerations for the proposed rule. Commenters also 
pointed out that these sources are used at tens of thousands of 
temporary job-sites annually and that their inclusion in the System 
would increase the already burdensome proposal by factors of hundreds 
or thousands. One commenter estimated that his company would amass an 
additional 41,250 reports annually if temporary job site transfers were 
included. Other commenters noted that it would require additional staff 
to make the reports; the estimates provided ranged from a quarter 
person-year to an additional full-time person. One commenter estimated 
that it would cost $41,600 annually to report source use at temporary 
job sites. Commenters also noted that due to the transitory nature of 
the temporary job sites, there may be no easy means of providing the 
information (i.e., no computer, no internet, fax, etc. at the remote 
locations). Commenters indicated that by the time the information was 
reported, it would no longer be valid as the source would already be at 
a new location. Commenters also pointed out that radiographers are 
required to maintain a utilization log for each source and that the 
logs are available for review by NRC or Agreement State inspectors.
    Commenters stated that as long as the source remains in the 
possession of the licensee, there would be an appropriate level of 
security. Several commenters noted that they are under an immediate 
detection assessment and response order; therefore, they already need 
to know where their sources are, and are required to respond to and 
report any problem to the NRC. They indicated that reporting temporary 
job site transfers would not improve incident response time. Several 
commenters stated that the volume of reports generated on temporary job 
sites would inundate the system and would likely require more manpower 
at the NRC. Another commenter noted that the risk of error would be 
increased due to the amount of movement of the sources on a daily 
basis. One commenter stated that the meaningless information would 
compromise the integrity of the entire database. Lastly, several 
commenters suggested that instead of reporting transactions involving 
temporary job sites, a shorter (monthly or quarterly) source inventory 
verification period should be imposed.
    Response: NRC has carefully considered the information provided by 
the commenters and has determined that temporary job site transactions 
should not be reported to the National Source Tracking System. 
Requiring reporting of temporary job site transfers would impose a 
large additional burden on licensees without a corresponding benefit. 
The information would not be beneficial as it would likely be out of 
date by the time it was reported to the tracking system. Thus, States 
would not be able to use the information for checking what sources are 
within their borders because the sources would likely have been 
relocated before the data could be entered. As for requiring a more 
frequent reconciliation period instead of temporary job site reporting, 
the purpose of temporary job site reporting, if required, was not to 
provide verification that a licensee is still in possession of a 
source. A more frequent inventory reconciliation would impose a large 
burden without a corresponding benefit. NRC is not requiring the 
reporting of sources being transferred to temporary job sites to the 
National Source Tracking System.

D. Inspection of Waste Shipments

    Waste brokers and disposal facilities are examples of licensees 
that might receive a nationally tracked source as part of a waste 
shipment. Because opening waste containers can result in unnecessary 
exposure for workers, these licensees typically do not open the 
containers to check contents, although a waste broker may open 
containers in order to consolidate shipments. After acceptance of a 
waste shipment, disposal facilities routinely move the container to the 
disposal area. The proposed rule did not require disposal facilities 
and waste brokers to verify the presence of the nationally tracked 
source in a waste container; they may rely on the verification of the 
licensee who shipped the source. Because there was to be no 
verification by the recipient that the source was in the waste 
container, NRC specifically invited comment on whether the waste broker 
or disposal facility should be required, at a minimum, to investigate 
the container for any indication of tampering. The inspection for 
tampering would provide additional assurance that the source was still 
in the container.
    Six commenters provided input on this question, including two 
Agreement States. The comments on this issue were mixed. One commenter 
stated that one cannot assume the material is present and that 
verification of the presence of

[[Page 65695]]

the source in the disposal container is necessary for an efficient 
tracking system. The commenter noted problems at several sites with 
trying to go back and determine exactly what happened to the material 
to be disposed. Two commenters supported some sort of verification but 
suggested the use of a tamper-proof seal for a visual indication of 
possible tampering with a container. Two commenters stated that the 
current system is adequate and that waste brokers and disposal 
facilities should not be required to open the containers because it 
would subject workers to additional radiation exposure. The commenters 
also noted that the tamper proof seals currently required on transport 
containers provide sufficient indication that the source is still in 
the container. One commenter stated that due to ALARA considerations, 
content verification should be performed only once, with subsequent 
reliance on container tamper seals. The commenter suggested that two 
signatures be obtained to verify contents of the package before the 
seal is applied and that this would be the responsibility of the 
original licensee packaging the source.
    Response: NRC has determined that no additional requirements are 
necessary for verifying waste shipments. NRC agrees that due to ALARA 
considerations, waste brokers and disposal facilities should not open a 
container to verify the presence of a source. Licensees must 
incorporate a feature, such as a seal, that is not readily breakable 
and that, while intact, would be evidence that the package has not been 
opened by unauthorized persons. Licensees generally verify that the 
seal is intact before handling the container, and NRC does not believe 
that it is necessary to require such a practice. If this becomes a 
problem, NRC would consider imposing additional requirements.

E. Quality Assurance

    The quality of the information reported to the National Source 
Tracking System is extremely important. While the proposed rule did 
contain a provision to correct errors within five days of discovery, 
there were no required pre-submission data quality checks. To address 
data quality assurance concerns, NRC specifically invited comment on a 
proposal to require licensees to double-check the accuracy of the data 
by using two independent checkers before submission of the transaction 
report. NRC sought information concerning whether the proposed quality 
assurance requirement was the appropriate requirement for quality 
assurance and if not, suggestions for appropriate requirements, and 
what additional burden a quality assurance requirement would impose on 
licensees.
    Twelve commenters, including three Agreement States, addressed 
quality assurance in their comments. Two of the commenters were in 
favor of quality assurance requirements. One commenter stated that 
inclusion of a quality assurance provision on data submission would be 
a good idea if it could be managed electronically, but was opposed to a 
counter signature approach. The other commenter supported a quality 
assurance provision if the verification was limited to comparison with 
manufacturer-supplied data or manifests and confirmation of tamper seal 
integrity.
    Ten commenters opposed adding additional quality assurance 
requirements. Several of the commenters stated that annual 
reconciliation should be adequate to ensure quality assurance. Several 
commenters stated that there is no reason to believe that the 
information provided by the shipper would not be accurate and that the 
validity of the information could be checked during inspection. 
Commenters also noted that some data quality assurance would occur when 
two parties are involved in a transaction; the recipient of a source 
verifies the data when acknowledging receipt of a source. One commenter 
stated that mandating a second review is too prescriptive. The 
commenter noted that most companies have a quality assurance program 
and should be able to make the decision internally whether a second 
review is required. The commenter was not aware of any other regulation 
that specifically requires a quality assurance check prior to 
submission of data to the NRC.
    Most of the commenters stated that requiring an independent check 
before data submission or any other requirement would impose a large 
financial burden on licensees, particularly smaller licensees. 
Commenters stated that for many small companies, resources are limited 
and personnel may not be available to conduct an additional check. 
Commenters noted that the requirement might necessitate the hiring of 
additional personnel. One commenter noted that if the quality control 
work was limited to confirming proper transcription of data, the burden 
would be about 30 minutes per transaction. One commenter noted that the 
inclusion of a quality assurance provision is no guarantee that an 
occasional error could not occur, and that the potential for error is 
reduced if the required recordkeeping and reporting are kept simple.
    Response: NRC has decided not to impose additional quality 
assurance on the data submission. The large additional burden that 
would be imposed, particularly on small licensees, is not warranted. 
The source tracking system will have some built-in checks; for example, 
an alarm will be triggered if information submitted by the transferring 
company and the receiving company do not match. The annual 
reconciliation will also serve a quality assurance function. The 
inspection program will also be revised to include inspections related 
to the National Source Tracking System. In addition, information 
submitted to the National Source Tracking System must be complete and 
accurate in all material respects as required by NRC regulations (for 
example, 10 CFR 30.9, 40.9, 50.9, 70.9, 76.9). If data quality becomes 
a problem, the NRC would consider imposing additional quality assurance 
requirements.

F. Data Protection

    In the proposed rule, NRC specifically invited comment on whether 
designation of the information as Official Use only would provide 
sufficient protection of the information or whether to require 
licensees to protect the information that is reported to the National 
Source Tracking System and, if additional protection is necessary, at 
what level of protection. Six commenters addressed this topic and 
supported retaining the designation as Official Use Only. While 
commenters agreed that the data is sensitive, they did not recommend 
additional provisions to protect the data. Commenters were opposed to 
designating the data as Safeguards Information (SGI) and noted that 
designation of the data as SGI would be onerous to implement and could 
result in unintended restrictions on routine data. Commenters stated 
concern about protection of the aggregated information and recommended 
that additional protection measures be taken. One commenter stated the 
information should be excluded from public disclosure under 10 CFR 
2.390.
    Response: NRC has decided that no additional measures are necessary 
to protect the information possessed by individual licensees. The data 
does not meet the definition of SGI and will be designated as Official 
Use Only--Security-Related Information once it is submitted to the 
National Source Tracking System. The information will be treated in the 
same manner as other

[[Page 65696]]

information designated as Official Use Only--Security-Related 
Information. A licensee will only have access to its information in the 
National Source Tracking System. Access for other persons, including 
NRC staff, will be on a need to know basis.

G. General

    Comment G.1: One commenter stated that the proposed rule would make 
great strides towards assisting the metals industry in eliminating 
radioactive sources from the scrap feed stock because it provides 
better oversight, management, and stewardship of certain sealed 
sources. The commenter believes that the National Source Tracking 
System requirement will provide the NRC the necessary oversight to 
ensure that these sealed sources would be less likely to be managed in 
a way that could lead to their inadvertent or intentional disposal in 
the waste or the recycling streams.
    Response: The commenter expresses general support for the rule, 
therefore, no response is necessary.
    Comment G.2: One commenter objected to the statement that National 
Source Tracking ``will provide greater source accountability which will 
foster increased control by licensees.'' The commenter indicated that 
the statement implies that the NRC believes that licensees have not 
been providing adequate accountability or control for these sources in 
the past. The commenter disagrees with this implication and cites the 
excellent record of licensees.
    Response: The statement was not intended to imply that licensees 
have not historically provided adequate accountability and control over 
these sources. However, in today's threat environment, NRC has 
determined that enhanced controls are necessary to ensure the continued 
protection of these materials. National Source Tracking is one aspect 
of the enhanced security program, and will provide NRC with information 
on what licensees actually possess verus what radioactive material they 
are authorized to possess.
    Comment G.3: Two commenters stated that there is no need for a 
national source tracking system and another commenter stated that the 
rule is in excess. One commenter stated that the sources are already 
tracked by the respective NRC office or Agreement State via licensing 
and inspection, noting that licensees are required to inventory their 
material. The commenter stated that the source tracking system would 
add an additional layer of bureaucracy and would be a waste of money. 
The second commenter stated that the proposed rule would increase costs 
for licensees without improving the security of licensed material. The 
commenter stated that the NRC already possesses information through the 
existing regulatory framework on who manufactures, receives, transfers 
and disposes of sealed sources. One commenter suggested that if NRC 
wants to track sources it should be via the submission of quarterly 
inventories.
    Response: NRC disagrees with the commenters. The Energy Policy Act 
of 2005 requires NRC to issue regulations for a mandatory source 
tracking system. Currently, sources are not tracked by either NRC or 
the Agreement States. Most licenses establish a maximum possession 
limit, but most do not list individual sources. While regulatory 
agencies know what material a licensee is authorized to possess, they 
may not know what that licensee actually possesses at its facility. 
While licensees are required to maintain an inventory of the 
radioactive materials that they possess, there is no requirement that 
they report their inventory to their regulatory agency, although 
inspectors may review the inventory listing as part of an inspection. 
The National Source Tracking System will provide the NRC with the up-
to-date information it needs to monitor the location of higher activity 
material; the submission of quarterly inventories would not be a 
sufficient tracking mechanism for these higher-risk radioactive 
sources.
    Comment G.4: One commenter stated that the proposed rule 
inappropriately references the IAEA Code of Conduct and suggests that 
the IAEA is asking for more than is already required in the present 
United States regulatory environment. The commenter expressed the 
belief that the United States regulatory framework for licensing 
already meets the IAEA requirements.
    Response: NRC disagrees with the commenter. The United States 
Government has made a commitment to comply with the recommendations in 
the IAEA Code of Conduct, so it is appropriate for the proposed rule to 
reference the IAEA document. The IAEA Code of Conduct specifically 
recommends that Member States establish a national source registry, a 
mechanism that is not part of the current U.S. regulatory framework.
    Comment G.5: A commenter stated that the proposed regulation 
violates the Agreement between the Agreement States and the Federal 
Government.
    Response: NRC disagrees with the commenter. There is no violation 
of the Section 274b. Agreements between certain States and the NRC. The 
commenter did not provide any additional information on exactly what 
aspect of the proposed rule was in violation. Promotion of the common 
defense and security was the basis for the proposed rule and on that 
basis NRC would not have relinquished that function to the Agreement 
States under Section 274b. of the Atomic Energy Act. However, upon 
further review the Commission has determined to promulgate the rule 
under its authority to protect the public health and safety.
    Comment G.6: One commenter pointed out that the statement 
identifying Category 3 sources as those that have \1/10\th of the 
radioactivity of Category 2 sources is misleading. The commenter noted 
that Category 3 sources also includes sources that have radioactive 
levels right up to the bottom threshold of the Category 2 sources.
    Response: The commenter is correct that Category 3 sources include 
sources that have activities up to the lower threshold of Category 2 
sources. A Category 3 source is a source containing radioactive 
material equal to or greater than the Category 3 threshold (\1/10\th of 
the Category 2 threshold) but less than the Category 2 threshold.
    Comment G.7: One commenter noted that the majority of sources that 
are lost or stolen every year are portable gauges, which are well below 
the Category 2 threshold, and that this rule would do nothing to help 
safeguard those sources.
    Response: The commenter is correct that this rule does not cover 
portable gauges. NRC issued a final rule on the security of portable 
gauges on January 11, 2005 (70 FR 2001). The rule became effective on 
July 11, 2005.
    Comment G.8: One commenter expressed support for the National 
Source Tracking System but stated that the system should meet the need 
to enhance the public health and safety as well as national security. 
Two Agreement States stated that the rule should be promulgated under 
health and safety and be classified as Compatibility Category B, 
particularly since it will be added to 10 CFR part 20, which delineates 
the general radiation safety standards. They indicated that States 
should be responsible for inspection and enforcement of the National 
Source Tracking System to ensure licensee compliance with the rule.
    Response: The NRC agrees that the National Source Tracking System 
will benefit the public health and safety and is changing the basis for 
the rule. Accordingly the final rule is being issued under the 
Commission's authority to protect the public health and safety and is 
classified as a

[[Page 65697]]

Compatibility Category B. The reporting provisions are being placed in 
10 CFR part 20 because part 20 applies to all licensees.
    Comment G.9: One commenter questioned the inclusion of several 
radionuclides. The commenter noted that Pu is already accounted for and 
licensed separately as special nuclear material and a national database 
would be redundant. The commenter also did not understand why Th-229 
and Cf-252 were included in the System since not many of these sources 
exist outside of DOE that exceed the threshold. The commenter asked if 
there were any future plans to track all sources no matter the size. 
One commenter also stated that the sources (Ir-192) are ill suited for 
use in RDDs or REDs.
    Response: Transfers of Pu are tracked in a separate database. 
However, the database is inventory based; individual sources are not 
reported, therefore, the database and the National Source Tracking 
System are not redundant. Because the National Source Tracking System 
is to be a national system, it will include transactions from DOE 
facilities; therefore, radionuclides of concern to DOE need to be 
included. It is true that not many licensees actually possess these 
sources, so this provision does not impact many licensees. As stated in 
the Statements of Consideration of the proposed rule, NRC may consider 
expansion of the National Source Tracking System to include Category 3 
sources at a later date (See Section A for further discussion of 
Category 3 sources). There are no plans to include other sources at 
this time. Ir-192 is included because it is listed in the Code of 
Conduct.
    Comment G.10: A commenter questioned the benefit of having two 
categories of sources, besides adding unnecessary complexity to the 
regulation. The commenter noted that there are few differences between 
the requirements for Category 1 and Category 2 sources.
    Response: The reporting requirements are identical for both 
Category 1 and Category 2 sources. However, the implementation date is 
different for the two categories. Future regulations codifying some of 
the NRC Orders may have different requirements for the two categories 
of sources.
    Comment G.11: One State supported not only the inclusion of 
Category 3 sources, but the inclusion of all non-exempt sources. The 
commenter supported the inclusion of non-exempt sources because of the 
view by emergency planners that any activity level of any radioactive 
material used in an RDD or RED would cause panic among the population.
    Response: Lower activity sources are not considered likely to be 
used in an RDD or RED. Inclusion of all non-exempt sources would impose 
a huge burden on licensees and would likely overload the tracking 
system such that the effectiveness of the system would be reduced.
    Comment G.12: Six Agreement States expressed support for the change 
in basis to public health and safety. (In addition, two Agreement 
States suggested issuing the rule under a basis of public health and 
safety during the original comment period in 2005.) The six States 
supporting issuance of the rule under public health and safety and as a 
Compatibility Category ``B'' argued that: States are better positioned 
than NRC to assure licensee cooperation; the States are better suited 
and able to perform this type of oversight than the NRC; the public 
health and safety basis would minimize the potential for the dual 
regulation of a State licensee; there would be less potential for 
licensee confusion; some licensees may be more comfortable and willing 
to respond when contacted by the State officials with whom they are 
familiar and have an established working relationship; National Source 
Tracking would not necessarily increase source security but it would 
increase source accountability, which is a function under health and 
safety; States are better able to react quickly when there may be 
discrepancies in the reported information than the NRC; States are able 
to inspect in a more timely and cost-effective manner than NRC when 
problems arise; National Source Tracking is a logical fit with the 
increased controls that States are already implementing; and Agreement 
States have demonstrated the ability to work cooperatively with the NRC 
on security initiatives under public health and safety. (NRC issued 
orders that required strengthening of the measures regarding the 
control over use and storage of Category 2 quantities of radioactive 
material. (70 FR 72128; December 1, 2005) Agreement States issued 
compatible legally binding requirements at the same time.)
    One industry organization also supported the basis change and 
supported the use of a single database. One industry organization was 
neutral. One commenter did not object to the basis change.
    Five Agreement States are opposed to the basis change. The opposing 
States argued: The State's ability to quickly implement health and 
safety requirements for the increased controls is not a reason to 
change the designation of the rule (common defense and security to 
public health and safety) and does not mean States have the resources 
or desire to do so for national source tracking; lack of resources to 
implement the program (e.g., lack of trained experienced inspectors); 
concern over the additional burden from the future inclusion of 
Category 3 sources in the tracking system; Congress intended source 
tracking to be a measure to promote the national security and changing 
the basis would violate the express intent of Congress; the federal 
government is attempting to shift additional responsibilities to the 
States simultaneously as it is withdrawing funding of the grant support 
from the Department of Homeland Security; and tracking of sources is 
not a local or State issue but a national issue. One of the Agreement 
States asserted that the NRC's authority to issue rules to promote 
common defense and security and its authority to issue rules to protect 
public health and safety have distinct applicability and limitations 
attached, and if the functions are intertwined, Congress could not 
assign the one responsibility to the Agreement States and the other to 
the Commission.
    One commenter stated that while there is certainly a nexus between 
safety and security, the motivation for the Energy Policy Act is the 
security of these materials. The commenter urged the Commission to 
reconsider its decision and return to a common defense and security 
basis which is necessary in order to faithfully implement Congressional 
intent.
    Response: The NRC agrees that the National Source Tracking is a 
logical fit with the increased controls that States are implementing. A 
public health and safety basis is consistent with the framework for the 
increased controls established by the Commission and NRC continued 
cooperation with Agreement States to implement a national materials 
program. In addition, implementation of the NSTS will not increase the 
physical security of sources; rather, it will improve the tracking of 
sources to support public health and safety. The NRC supports issuance 
of the final rule under it public health and safety authority. NRC will 
develop and will maintain a single National Source Tracking System. 
Agreement State licensees will report to the national system. The 
Agreement States will be responsible for issuing legally binding 
requirements to their licensees that will require reporting of the 
necessary data. The legally binding requirements will be identical to 
the rule requirements

[[Page 65698]]

and will be issued such that they are effective at the same time as the 
rule.
    The National Source Tracking rule solely concerns collecting data, 
submitting it to a national data base developed and maintained by the 
NRC, and ensuring the data are appropriately updated in a timely 
manner. As such, the National Source Tracking System fulfils the 
Congressional mandate in the Energy Policy Act that the NRC establish 
by regulation such a system for tracking radioactive sources. Issuing 
this rule under the NRC's authority to protect the public health and 
safety in no way diminishes NRC authority to take appropriate action, 
nor lowers the significance of NRC actions. In fact, the safety of the 
public is the main reason for implementing security measures for 
radioactive materials. NRC is very aware of the resource concerns 
expressed by the five Agreement States which oppose the basis change. 
NRC will work with all of the Agreement States to further verify the 
rule requirements, the implementation period and approach, understand 
resource impacts of system implementation, and identify and address 
implementation issues as they arise.
    Comment G.13: One Agreement State argued that the switch of the 
basis for adoption of the rule does irreparable harm to the States by 
denying them meaningful opportunity for input in a rulemaking that will 
place direct demands upon State resources. The State asserted that the 
fact that only six States submitted comments on the proposed rule 
attests to the States' perception that the matter had little impact 
upon them. The State also asserts that the change in basis amounts to a 
substantive change in the rule and requires that the entire rule be 
reopened for comment. One commenter requested information on Agreement 
State interactions.
    Response: The NRC disagrees with the commenter. The States have had 
many opportunities to provide input to the National Source Tracking 
System. Representatives of the States participated in the development 
of the requirements for the system and development of the rule. The 
rule and system have been discussed at the Organization of Agreement 
States annual meetings and the Conference of Radiation Control Program 
Directors annual meetings. The NRC disagrees that the change in basis 
warrants that the entire rule be reopened for comment. The basis change 
was initiated by comments received from several Agreement States and is 
consistent with the framework established for the increased controls.
    Comment G.14: Two Agreement States, while supporting the basis 
change, recommended that NRC consider revising the security orders 
issued to certain manufacturer and distributor licensees to implement 
the source tracking reporting requirements. The commenters stated that 
this could reduce the regulatory burden for those Agreement States that 
have a large number of manufacturer and distributor licensees that 
routinely transfer large numbers of Category 1 and 2 sources.
    Response: Because the final source tracking rule is being issued 
under the basis of public health and safety, the Agreement States will 
be responsible for issuance of legally binding requirements for their 
licensees that possess Category 1 or 2 sources, including State 
licensees that received NRC orders. NRC has chosen to impose the 
tracking system reporting requirements by rule rather than by orders. 
See also response to Comment G.12 concerning resources.
    Comment G.15: One Agreement State disagreed with the statement that 
``the requirements are laid out in the rule and it should be a 
straightforward matter for States to develop the legally binding 
requirements.'' Two States also disagreed with the estimate of 
approximately 1 hour for inspection. The States indicated that their 
experience with inspecting for the increased controls as part of 
routine inspections demonstrated that NRC underestimated the effort 
involved. One State indicated that NRC has not allowed for or provided 
adequate training opportunity for the State to conduct these 
inspections.
    Response: The NRC staff disagrees with the comment. The rule does 
lay out the reporting requirements that Agreement States will need to 
impose on their licensees. NRC will work with the States to develop the 
legally binding requirements for State licensees. In reference to 
training, it is not clear if the commenter is referring to training 
related to inspections for the National Source Tracking or the 
increased controls. A Temporary Instruction will be issued for use by 
NRC inspectors; Agreement States will have access to the instruction 
and can also use it to conduct inspections. As for the time estimate 
required for the inspection, NRC staff believes one hour on average to 
be adequate to perform a simple check to make sure that the licensee 
has accurately reported sources to the National Source Tracking System. 
NRC will also utilize existing mechanisms for communicating and working 
with the Agreement States to help ensure a consistent uniform national 
approach to implementing the rule. We will use an approach similar to 
the one we used with the increased controls, e.g., routine calls, 
electronic communications, formation of an NRC-State working group. 
Through these interactions, the NRC will continue to coordinate with 
the states to understand any issues with the impact of NSTS 
implementation on state resources.
    Comment G.16: One commenter requested information on the budgetary 
needs for implementation of the National Source Tracking System and 
copies of correspondence. The commenter requested information on the 
cost for Agreement States to develop their own tracking systems and how 
they would coordinate transfers between licensees in different 
geographic locations.
    Response: Information on the cost of the rulemaking is available in 
the Regulatory Analysis completed to support this rulemaking and 
relevant correspondence is available in ADAMS. Under this framework, 
NRC will develop and will maintain the tracking system; Agreement 
States will not be developing their own systems. All licensees will 
report to the national system. Agreement States are not expected to 
coordinate the tracking of sources when transfers to different states 
occur.
    G.17: One commenter stated that transactions involving aggregation 
of sources whose activity level, if taken together, exceed the Category 
2 threshold should be included because the security and safety threats 
of such a transaction would be the same as that associated with a 
transaction involving a single Category 2 level source. The commenter 
further asked how, from a security and safety perspective, NRC could 
justify tracking an import of aggregated Category 2 sources until the 
sources reach the U.S. after which they might be essentially ignored if 
such aggregated sources are not included in the tracking system.
    Response: The NSTS will not consider transactions involving the 
aggregation of sources. The System will be an item-level tracking 
system for individual sources. If aggregation were considered, the 
smaller sources would be entering and exiting the system. The system 
data would become unreliable as the source moved in and out of the 
system. Some licensees would be required to report information on 
Category 3 sources and some would not. It is important to note that the 
NSTS does not impose any additional security requirements on the 
sources. The security and control measures are imposed by Order or 
other legally binding requirements. Those security

[[Page 65699]]

and control requirements do consider aggregation of sources. 
Additionally, imports of Category 1 and 2 radioactive material are not 
tracked under the import/export rule, but licensees are required to 
provide notification to the U.S. government of the estimated arrival 
date for imports.
    G.18: One commenter stated that a February 26, 2006, report by the 
NRC Inspector General (IG) entitled ``Audit of the Development of the 
National Source Tracking System (NSTS)'' found that the proposed 
tracking system ``may not account for all byproduct material that 
represents a risk to the common defense and security and public health 
and safety. Such risks could result in economic, psychological, and 
physical harm to the United States and public.'' The commenter 
requested information on whether the two recommendations from the 
report: (1) To conduct a comprehensive regulatory analysis for the NSTS 
that explores other viable options and (2) to validate the existing 
data in the Interim Database were followed prior to the Commission 
vote.
    Response: The rule on National Source Tracking was originally 
developed for Category 1 and 2 sources. Data were not available to 
conduct a cost-benefit analysis of including additional sources in the 
tracking systems. As for validating data in the Interim Database, the 
staff did take some measures for improvement in the 2005 survey of 
licensees. The analysis of the 2005 data was available before the 
Commission vote.
    G.19: One commenter requested information on Agreement State 
responsibility to share information when a source is missing, lost, or 
stolen. The commenter also requested information on coordination with 
Agreement States and U.S. Customs and Border Protection to confirm the 
legitimacy of imports of shipments of risk-significant sources. The 
commenter requested the complete timeline for the process of adding 
Category 3 sources to the tracking system, what analysis would be 
required, and information on Agreement State regulation of Category 3 
sources.
    Response: This rule does not change the requirements for reporting 
of lost, stolen or missing sources. The U.S. Customs and Border 
Protection program is not impacted by this rule, and the notification 
information is required by the import/export rule. Agreement States do 
not have authority to issue import or export licenses as that is 
reserved for the NRC. The inclusion of Category 3 sources is addressed 
in this section, item A. All Agreement States regulate Category 3 
sources.

H. Rule Language

    Comment H.1: One commenter stated that manufacturers should only be 
required to report upon the transfer of sources. The commenter noted 
that sources are manufactured based on specific orders and that the 
sources are transferred quickly to the recipient (the same day or 
within a couple of days of each order). The commenter stated that 
requiring reporting of both the manufacture and the transfer of sources 
would impose an unnecessary burden on the manufacturer to enter the 
information twice. The commenter noted that entering data upon 
manufacture would not provide any useful information as that source 
would be shipped out and that the creation date is irrelevant in the 
context of tracking the locations of sources once they are in use.
    Response: The manufacture date is the point of origin for the 
source, and is needed by the system to calculate decay of the source. A 
manufacturer may report both the manufacture of a new source and the 
transfer of the source in a single report, provided that the transfer 
occurs within the reporting timeframe of the manufacture and the 
licensee submits all information for both transactions. If the transfer 
occurs after the close of the next business day after the date of 
manufacture, the licensee must make two separate reports.
    Comment H.2: Two Agreement States suggested that additional 
information should be collected on the transactions. The commenters 
stated that the information should include the State in which the 
source is located, the State to which a source is being transferred, 
and the State from which a source is transferred.
    Response: The NRC agrees with the commenter. The information on the 
States involved in a transaction is part of the system. Licensees will 
provide the actual address (location of a facility) when establishing 
an account in the system. The final rule language has also been revised 
to add the address of the licensee as required information.
    Comment H.3: One commenter stated that the rule was missing a 
transaction on recycling of sources, or disposal or disassembly of 
sources for recycling. The commenter noted that the disposal 
transaction does not adequately capture this activity because it 
requires a waste manifest number. The commenter noted that his company 
disassembled 1,809 Co-60 sources in the last year, and that these 
sources would have been tracked in the National Source Tracking System. 
The commenter noted that new sources were created out of the recovered 
Co-60. The commenter stated that this type of transaction should be 
treated similar to a disposal transaction but without a waste manifest 
number. The commenter provided draft rule language for consideration 
and also noted that NRC Form 748 would need to be revised to reflect 
the new transaction. Three commenters asked how remanufacturing 
(recycling) of sources would be handled. The commenters noted that when 
older sources are melted down and new sources are created, the unique 
serial number is lost. The commenters stated that the tracking system 
needs to be able to address this type of situation.
    Response: The NRC agrees with the comments and has added a new 
transaction for disassembly of a source to the final rule. The rule 
requires a licensee that disassembles a source (for any reason) to 
report the transaction. This is an irreversible endpoint for the source 
within the tracking system. If the material is used to generate a new 
source, the licensee must report the generation as a new source 
manufacture. NRC Form 748 has been revised to add this new disassembly 
transaction.
    Comment H.4: One commenter suggested that in the definition of 
Nationally Tracked Sealed Source, the term ``permanently'' should be 
deleted in the phrase ``permanently sealed'' because of recycling 
considerations.
    Response: The NRC agrees with the commenter and the definition has 
been so revised.
    Comment H.5: An Agreement State commented that June would be a bad 
month for academic licensees to conduct the required annual 
reconciliation of their data because school is out and some Radiation 
Safety Officers take summer vacation and thus would not be available to 
conduct the reconciliation. The commenter suggested September or 
October as alternatives.
    Response: The month of June was selected in the proposed rule based 
on the proposed implementation date of the final rule. Because the 
implementation date of the final rule has changed, the reconciliation 
date has also changed. Reconciliation will be required in the month of 
January each year. In determining a suitable time for reconciliation, 
NRC took into consideration the implementation date of the new 
reporting requirements, the academic calendar, and peak work periods 
for radiographers.
    Comment H.6: Two commenters requested that the reporting timeframe 
of the close of the next business day be extended because it would be 
too stringent and might be hard to meet. Commenters requested that the

[[Page 65700]]

timeframe be extended to three to five days. One commenter noted that 
one individual in each office, likely the Radiation Safety Officer, 
would be given the responsibility to make reports and that he/she might 
not always be available in that timeframe, particularly when there were 
a lot of other activities in the office. Another commenter noted that 
extending the reporting requirement to 5 business days would enable 
licensees involved in the transaction to verify that the transaction 
has been completed. One commenter stated that reporting by the close of 
the next business day would not be appropriate for Category 2 sources, 
but did not address Category 1 sources. The commenter believes the 
proposed reporting by the next business day requirement would be 
without value for enhancing the security of sources and responses to 
thefts and would be overly burdensome. The commenter noted that there 
are already requirements for immediate reporting of the loss or theft 
of a source and that reporting to the National Source Tracking System 
would not increase the physical security of the source or improve the 
response time of authorities in the event a source were stolen. One 
commenter suggested that instead of requiring reporting by the close of 
the next business day, that the NRC consider requiring licensees to 
maintain a record of the present location of the sources, make a 
monthly report of the movement of sources to ensure the national source 
registry is maintained, and to notify the planned recipient. The 
commenter further suggested that the NRC expand the reporting 
requirements in 10 CFR 20.2201 to require reporting within 24 hours 
when Category 1 or Category 2 sources in transit cannot be located.
    Response: Although the Energy Policy Act of 2005 requires reporting 
a change in possession of a source within 7 days, the final rule 
requires reporting by the close of the next business day. The timing of 
reports was discussed within the Interagency Coordinating Committee and 
the conclusion was that allowing up to 7 days for reporting 
transactions was too long for reporting transactions. The Committee 
indicated that reporting should be by the close of the next business 
day. In addition, allowing a longer timeframe could create a situation 
in which the source recipient might report the receipt of a source 
before the sender of the source reports that the source had been 
transferred. NRC has determined that the close of the next business day 
is an appropriate timeframe for reporting.
    Comment H.7: Two commenters suggested that rule language be added 
to specifically state that sources that decay below the Category 2 
threshold values are automatically removed from the system and that no 
reporting would be required by licensees.
    Response: Specific language is not needed in the rule text to 
incorporate the commenter's suggestion. A Nationally Tracked Source is 
defined in terms of Category 1 and Category 2 levels of any radioactive 
material listed in Appendix E. Once a source has decayed below the 
Category 2 threshold, by definition, it is no longer a nationally 
tracked source and is not required to be reported to the National 
Source Tracking System. The data on the source will, however, be 
retained in the system.
    Comment H.8: One commenter proposed that a leak test be required 
(or confirmed as current) prior to shipping any Category 1 or Category 
2 source to ensure that if any source is leaking that it be identified 
at the point of origin as opposed to the point of receipt.
    Response: Leak testing is beyond the scope of this rulemaking. 
Licensees are required to periodically conduct leak tests on sealed 
sources for health and safety reasons. For the purposes of National 
Source Tracking, leak tests are not necessary.
    Comment H.9: One commenter requested clarification on whether the 
activity levels in the table (Appendix E) apply to the parent 
radionuclides and the daughter products or just to the parent 
radionuclides.
    Response: The activities in the table do not include daughter 
products.
    Comment H.10: One commenter stated that for some radionuclides, 
such as Pu, the amount should be reported in grams instead of activity 
units.
    Response: The official threshold unit for the National Source 
Tracking System is Becquerels. However, the system will allow reporting 
in other units, including grams. The system will automatically conduct 
the conversion into Becquerels.

I. Regulatory Analysis

    Comment I.1: A commenter stated that Option 1 (no action) in the 
Regulatory Analysis is more viable and should be given consideration 
because the tracking system will be very costly to the stakeholders 
with little or nothing being gained by the stakeholders.
    Response: The NRC disagrees with the comment. Although the rule 
does impose some additional burden on licensees, the NRC believes that 
the information to be gained is valuable. In addition, the Energy 
Policy Act of 2005, signed into law after publication of the proposed 
rule, requires NRC to issue regulations establishing a mandatory system 
for national source tracking. The no action alternative is no longer a 
viable option.
    Comment I.2: One commenter noted that the draft Regulatory Analysis 
shows approximately 93 percent of the cost being borne by the NRC. The 
commenter stated that since the NRC acquires its revenue through fees 
on licensees, all of the cost of the system will be borne by the 
licensees and would end up costing each licensee approximately $18,000 
annually. Another commenter questioned where the money to pay for the 
system will come from, noting if there are to be fees associated with 
the database, this should be spelled out now.
    Response: There are no direct fees associated with the National 
Source Tracking System. The cost of the system has been removed from 
the fee basis and will not be recovered through annual fees.
    Comment I.3: One commenter questioned how the tracking system would 
improve public health.
    Response: The Regulatory Analysis did not state that the tracking 
system would improve routine public health. The attribute discussed in 
the Regulatory Analysis is public health (accident/event) and the 
document stated that the tracking system would have a positive effect. 
The National Source Tracking System is discussed in terms of being a 
preventive measure and having the capability to avert potential health 
effects. The National Source Tracking System will provide regulators 
better information on where sources are located and who possesses them. 
Having this information should reduce the possibility that the material 
could be used in an RDD or RED. As other commenters have pointed out, 
the tracking system should also reduce the chance of sources being 
introduced into the scrap metal stream.
    Comment I.4: One commenter stated that the draft Regulatory 
Analysis grossly underestimates the cost and time it will take for 
industry to comply with the new requirements. The commenter stated that 
the NRC did not include any cost or time in order for industry to put 
systems in place and that licensees will need to write specific 
computer programs to collect the information. The commenter stated that 
approximately 80 man hours would be needed to implement the 
requirements of the new rule.
    Response: It should not be necessary for most licensees to put any 
new systems in place or write computer programs in order to implement 
the rule. Licensees should already have the information required to be 
reported to the National Source Tracking System,

[[Page 65701]]

and will only need to log onto the system and enter their data. For 
those licensees that plan to use the electronic batch method, some 
computer programing may be necessary. The Regulatory Analysis has been 
revised to reflect this burden.

J. Implementation

    Comment J.1: One commenter requested that industry be given 
adequate time to change procedures and conduct any necessary training 
before implementation of the rule. Another commenter requested guidance 
on the information technology aspects of implementing the system 
because it is going to take some effort to develop the process for 
electronic data downloads to the system. Commenters also requested 
information on when the workshops would be held.
    Response: The provisions for reporting transactions are not 
effective for over 6 months from the publication date of the final 
rule. Licensees should have adequate time to train staff on new or 
revised procedures, if necessary. The information technology guidance 
will be made available prior to rollout of the system. The NRC will be 
holding licensee workshops before the rule's effective date. The dates 
for the workshops have not been set. NRC will give licensees ample 
notice once the dates and locations for the workshops have been 
determined.
    Comment J.2: Three commenters stated that manufacturers typically 
ship newly manufactured sources the same day as their manufacture or 
within a day or two and that it would not make sense to then require 
the manufacture to reenter the data for transfer of the sources. The 
commenters suggested allowing one entry or form to cover both 
transactions.
    Response: NRC will allow the use of the same form for those sources 
that are manufactured and shipped on the same day. Licensees will need 
to check both transactions on the form.
    Comment J.3: One commenter noted that a big education campaign 
needs to be conducted for both licensees and Agreement States. The 
commenter noted the need for NRC and Agreement State compatibility and 
consistency in implementation and education. Commenters noted that 
implementation of the final rule will require extra effort to assure 
that Agreement State licensees are contacted and fully aware of the 
requirements of the rule.
    Response: NRC agrees with the commenter on the need for training. 
Both NRC and Agreement State licensees will receive information on the 
National Source Tracking System, including information on how to 
establish an account, and information on training. The initial contact 
list will be based on licensees in the interim database. NRC will also 
work with the Agreement States to make sure that all impacted licensees 
are reached. NRC will be sponsoring workshops for both NRC and 
Agreement State licensees. NRC will also hold training sessions for 
Agreement State staff.
    Comment J.4: Three commenters asked how corrections of data would 
be handled, both electronically and by paper. The commenters noted that 
without some method of noting a correction, the corrected information 
might be treated as a double transaction.
    Response: The paper form has been revised to include a box to check 
for corrections. Users will also be able to correct transactions 
electronically. Development of the system is not complete, but in 
general, a licensee will be able to access its data, pick a transaction 
or source and click on a screen that will allow revisions.
    Comment J.5: One commenter requested information on who would have 
access to the database and to what extent. The commenter requested 
information on how the database will be used and how it would improve 
security of nationally tracked sources. The commenter requested an 
example of how the database would be used and when. One commenter 
stated that the low-level waste compacts should be allowed to have 
unqualified access to the data in the National Source Tracking System 
database because access would facilitate determining future regional 
needs for disposal of sources. The commenter further stated that access 
would facilitate the exportation from the compact region of devices for 
disposal and that records maintained by the compact would confirm 
occurrence of the transaction.
    Response: Each licensee will have access to data on its own 
material and facility. Agreement State officials will have access to 
data on licensees within their own State. DOE officials will have 
access to data on DOE sites. Some NRC staff will have access to all of 
the data in the system. Other agencies will only have limited access to 
the data on a need to know basis. NRC will establish a procedure for 
handling requests from groups/agencies for data access. As stated in 
the Statement of Considerations for the proposed rule, the National 
Source Tracking System itself will not improve the physical security of 
these materials. The System may improve accountability of material and 
is part of the overall security program.
    Comment J.6: One commenter asked whether a Radiation Safety Officer 
for a licensee with multiple locations in various NRC and Agreement 
States would have access to manage the information in the database for 
the various locations.
    Response: Yes, a Radiation Safety Officer for multiple locations 
could arrange to have access to the information for all of the sites 
for which he/she is responsible. Access will be arranged during the 
setup of the account information for the licensee.
    Comment J.7: Two commenters stated that there should be a provision 
to allow licensees to address multiple sources with a single 
transactional entry. The example provided is the 201 distinct sealed 
sources contained in a gamma knife. Each source is serialized 
sequentially and has nearly equal activities.
    Response: Licensees will be able to report multiple sources that 
are serialized sequentially. The on-line and batch method will easily 
accommodate this action. Licensees using the paper forms will need to 
use the comment box to provide such data.
    Comment J.8: One commenter stated that the NRC should consider the 
time and resources that will be needed for compliance with the rule. 
The commenter stated that the rule would require additional manpower 
and office equipment and place a significant financial burden on a 
healthcare delivery system already under stress. The commenter asked 
that NRC support efforts to lobby Congress, CMS, and private payers to 
increase funding for the delineated radionuclide procedures to 
alleviate the financial burden placed on medical institutions. The 
commenter also asked that source tracking be postponed until such 
funding is secured.
    Response: NRC acknowledges that the National Source Tracking System 
imposes additional burden on licensees required to report transactions 
to the system. NRC is taking measures to reduce the reporting burden. 
Licensees can report using several different mechanisms, with on-line 
and electronic reporting being the least burdensome. Licensees will not 
be required to invest in any additional equipment to make their 
reports. Most licensees already have computers and internet access. The 
request to lobby Congress and others is beyond the scope of the 
rulemaking.
    Comment J.9: One commenter stated that the NRC should make a 
commitment to international harmonization on source tracking and take 
whatever steps are appropriate

[[Page 65702]]

towards that goal before implementation of the tracking system. The 
commenter stated that harmonization is needed because tracking systems 
implemented by other countries need to work smoothly with NRC 
regulations if tracking systems are to be effective and efficient. The 
commenter stated that if implementation by all national authorities is 
based on a common set of definitions and operating principles, 
equitable trade opportunities will be maintained. Two commenters 
encouraged harmonization with other countries, specifically with Canada 
and the United Kingdom, to ensure a compatible Web interface and data 
format. Another commenter stated that it is imperative that all 
countries implement national source tracking consistently and in the 
same time-frame, otherwise the rule will be only partly effective as 
tracking could be lost once sources are exported out of the United 
States. One commenter noted that if the tracking methods are identical 
information could be sent to both countries simultaneously.
    Response: The source tracking system is a domestic system and 
should have no impact on trade opportunities with foreign countries. 
The system is not intended to track sources once they are exported out 
of the United States. NRC staff has met with Canadian officials to 
discuss source tracking. NRC staff has also attended international 
meetings to discuss Code of Conduct implementation, including source 
tracking. The import/export notifications are not part of this 
rulemaking.
    Comment J.10: One commenter stated that the paper forms for 
reporting transactions are dysfunctional. The commenter stated that 
shipment of multiple sources would require the completion of multiple 
forms and would take several hours to complete. The commenter stated 
that the forms cannot be used in their current format and should be 
revised.
    Response: The commenter did not provide any specifics as to the 
deficiencies with the form or make any suggestions for improvement. If 
a licensee chooses to use the paper form, it will be limited in the 
number of sources that can be included on the form; the size of the 
form is limited. Instead of filing multiple forms, the licensee could 
attach an addendum sheet that lists all of the sources for a 
transaction. The licensee would simply need to add a note to the 
comment section that states ``see addendum for additional sources.'' 
The NRC has revised the instructions for the form to explain this 
option. For reports made online, there will be no limit to the number 
of sources that can be included in a single transaction report.
    Comment J.11: One commenter urged the NRC to combine the reporting 
required under the import/export final rule (70 FR 37985; July 1, 2005) 
with the reporting required under this rule. The commenter stated that 
it would be redundant for a licensee to notify the NRC twice of every 
international shipment and would add an undue and unnecessary paperwork 
burden.
    Response: The initial deployment of the National Source Tracking 
System will not have the capability to allow licensees to report the 
notification information required by the import/export final rule. The 
System will provide this capability in a later deployment.
    Comment J.12: One commenter stated that the NRC should expand its 
use of electronic systems for data reporting to include reporting 
required by the security orders to help reduce duplicative reporting. 
The commenter also advocated use of one central database for all 
notifications. Other commenters stated that NRC needs to perform a 
comprehensive review of all the various Orders and regulations that 
have been issued and proposed over the last two years to address any 
inconsistencies and duplication. One commenter stated that licensees 
are required to provide increased controls/security measures for the 
receipt, transfer and movement of sources, and therefore, the rule is 
repetitive.
    Response: NRC disagrees that the rule is repetitive with the 
increased controls/security measures for the receipt transfer and 
movement of sources. The increased controls/security measures do not 
require transaction reporting to NRC and the NRC is not aware of any 
duplication in the measures and this rule. NRC is not aware of any 
inconsistencies related to this rulemaking and the various Orders, 
increased controls or security measures. The other comments are beyond 
the scope of this rulemaking.
    Comment J.13: One commenter asked how the NRC is going to assure 
that all licensees enter data as required. The commenter asked what 
would be done if the recipient does not enter data and the initial 
shipper subsequently receives information that the source has decayed 
below the reporting threshold.
    Response: Data entry for the National Source Tracking System is 
subject to inspection. If licensees are not reporting data as required, 
NRC and the Agreement States can take enforcement action. The system 
will have built-in features that will trigger an alarm for mis-matched 
transactions. The system will not catch situations in which both sides 
of the transaction have failed to report; however, these transactions 
should be captured and corrected during the annual reconciliation 
process. In addition, licensees reporting to the National Source 
Tracking System are subject to requirements in NRC regulations (for 
example, 10 CFR 30.9) that information provided to the NRC shall be 
complete and accurate in all material respects.

K. System Aspects

    Comment K.1: One commenter suggested that the National Source 
Tracking System should be operated as a separate and independent system 
under the current Nuclear Materials Management and Safeguards System 
(NMMSS). The commenter stated that this would result in significantly 
lower costs for system development and operation, improved quality of 
the information, and less burden on licensees.
    Response: This comment is beyond the scope of this rulemaking. This 
rulemaking establishes the reporting requirements for the National 
Source Tracking System. The actual database development and operation 
is not conducted through rulemaking; the NRC will obtain the system 
through a formal procurement process. Section L addresses the use of 
NMMSS for byproduct source tracking.
    Comment K.2: A Federal agency requested that the NRC work jointly 
with it on a data sharing format to allow them and other agencies to 
use National Source Tracking System data. The commenter stated that 
agencies across the Federal government should have the opportunity to 
leverage the data collected by extracting other information useful to 
the American public, thereby representing potential benefits to 
government agencies and the American public.
    Response: An Interagency Coordinating Committee was formed to 
address these and other issues. Other agencies will be allowed access 
to the data on a need to know basis. NRC, in conjunction with the 
Interagency Coordinating Committee, will develop a procedure for 
handling requests for data access.
    Comment K.3: One commenter requested information on how the 
database information would be safeguarded from computer hackers. The 
commenter stated that if a terrorist gained access to the database, 
they would have access to a listing of all the large sources. 
Therefore, the commenter believes that a national database

[[Page 65703]]

actually reduces national safety instead of improving it.
    Response: NRC shares the commenter's concern about computer 
security. The National Source Tracking System will receive security 
accreditation before it can be used. The security information for the 
system will not be made publicly available.
    Comment K.4: One commenter suggested that the source tracking 
notification system should include an automatic e-mail notification 
when a sender designates a specific licensee in a transfer entry as 
this would allow rapid identification of errors in the system at the 
time of transfer.
    Response: The source tracking system will have some automatic 
notification features that will be designed to reduce errors.
    Comment K.5: Three commenters noted that NRC should have 
interactions with the users of the system prior to the demonstration 
workshops that are planned. In addition, commenters stated that NRC 
should establish a users group composed of a cross-section of members 
of the affected community to develop the formats, input means, and 
reports that will be available through the system. The commenter stated 
that this will assure that the system is user-friendly while still 
meeting NRC's needs. One commenter stated that representatives of 
industry must be part of the design team and that this will provide an 
opportunity to review the specifications for the system to understand 
how the Web interface will operate and what kind of `machine readable' 
data format will be used. Another commenter noted that NRC needs to pay 
attention to the human side of the database to avoid chaos with the 
data collection.
    Response: NRC plans to have interactions with stakeholders during 
development of the format for the electronic batch files. The names of 
those licensees that have expressed interest in participating will be 
provided to NRC staff involved in system development. The NRC will 
consider the suggestion that industry representatives participate on 
the design team.
    Comment K.6: One commenter stated that as written the rule would be 
extremely burdensome for both licensees and regulators. The commenter 
stated that NRC does not fully understand the undertaking of this rule. 
The commenter encouraged NRC to work with the industry in the 
implementation of the rule and the development of the Web-based system.
    Response: Although the rule does pose additional burden on 
licensees and NRC, the burden is not extreme. The source tracking 
system is an important national initiative that justifies the burden 
and is in fact required by statute (the Energy Policy Act of 2005). NRC 
has a clear understanding of the implications of this rule for both 
industry and NRC. (See also response to K.5.)
    Comment K.7: One commenter suggested that NRC should be required to 
provide a unique tracking number for each source in the tracking 
system.
    Response: The National Source Tracking System uses a combination of 
the manufacturer, model number, and manufacturer assigned serial number 
to identify the sources. The system will assign a unique number for 
each source entered in the system.

L. Miscellaneous

    Comment L.1: One commenter requested clarification on whether the 
proposed rule covers transactions involving devices returned to the 
manufacturer for long term disposal.
    Response: The rule covers all Category 1 and Category 2 sources in 
the possession of NRC licensees, regardless of whether they are being 
actively used or are in long term storage. The rule covers the source 
within the device and not the device itself.
    Comment L.2: A commenter stated that they could not find the basis 
for the limits (thresholds) in the IAEA Code of Conduct. The commenter 
stated that the values seemed random or arbitrary, specifically the 
limits for americium, Th-229, and Ir-192. The commenter further 
questioned the addition of several short-lived radionuclides (Ir-192, 
Se-75, and Yb-169) and stated that tracking these materials was neither 
prudent nor practical.
    Response: As stated in the Statements of Consideration for the 
proposed rule, IAEA-TECDOC-1344 entitled ``Categorization of 
Radioactive Sources'' provides the underlying methodology for the 
development of the Code of Conduct thresholds. TECDOC-1344 is now RS-G-
1.9. The categorization system is based on the potential for sources to 
cause deterministic effects and uses the `D' values as normalizing 
factors. The `D' values are radionuclide-specific activity levels for 
the purposes of emergency planning and response. The same methodology 
was used for all of the radionuclides.
    Comment L.3: The commenter stated that regulations that focus on 
the transportation of Category 1 and Category 2 sources would be more 
appropriate.
    Response: Transportation requirements are beyond the scope of this 
rulemaking.
    Comment L.4: One commenter objected to the National Source Tracking 
System automatically delisting and no longer tracking sources at the 
point at which they decay below Category 2 levels. The commenter noted 
that many licensees may believe that their management responsibilities 
also cease when the source decays below the Category 2 threshold, which 
could result in more Category 3 sources ending up in the scrap or the 
recycling streams.
    Response: Licensees are responsible for the safety and security of 
all radioactive material in their possession, regardless of activity 
level. Both NRC and the Agreement States have inspection programs to 
ensure that licensees operate within the bounds of their licenses. The 
National Source Tracking System only includes information on Category 1 
and Category 2 sources. Once a source decays below the Category 2 
threshold, the source is no longer a Category 2 source and the 
reporting requirements no longer apply. However, historical data on the 
source is not automatically deleted and will be retained by the system.
    Comment L.5: Commenters noted that the Security Orders require 
notification of the end user of a shipment of a Category 2 source and 
verification of the arrival of the source, therefore, a mechanism is 
already in place that says the transition took place.
    Response: It is correct that notification and verification 
requirements have been imposed on some licensees possessing Category 1 
and/or Category 2 sources. However, the information is not reported to 
the NRC. Without the tracking system, the NRC would not have 
information on what sources a licensee actually possesses.
    Comment L.6: One commenter noted that there are some differences 
between how other countries are implementing similar regulations. The 
commenter stated that the European Union has the High-Activity Sealed 
Source (HASS) directive, which has different quantities that need to be 
reported. The Commenter indicated that the NRC needs to look at this 
closely.
    Response: From an international perspective, it may be desirable 
for all countries to implement regulations in a similar manner; 
however, the National Source Tracking System is a domestic tracking 
system. That said, the NRC does try to keep abreast of what other 
countries are doing. The European Union (EU) directive only applies to

[[Page 65704]]

transfers within the bounds of the EU countries.
    Comment L.7: One commenter noted that some of the countries from 
which they obtain material will not be providing them the specific 
serial numbers for the sources in advance. The commenter states that it 
will be difficult to track the material before it is in their 
possession.
    Response: This final rule does not require licensees to report any 
information on sources that are imported until the sources are received 
at the licensee's facility. The import/export rule (70 FR 37985; July 
1, 2005) does require importers to provide NRC notification of imports. 
The notification requirements do include the serial number of the 
source, if available.
    Comment L.8: One commenter suggested that a possession threshold 
amount be established that, if exceeded, would trigger tracking 
requirements in order to avoid an undue burden on community medical 
facilities that only possess very small quantities of the lower 
activity sources.
    Response: A threshold possession limit does not work for an item-
level tracking system. Sources would move in and out of the system 
depending on how much a particular licensee possessed at a site. A 
threshold that applies to all licensees is the appropriate method for 
tracking these sources and is how the National Source Tracking System 
will operate.
    Comment L.9: Two commenters stated that aggregation should not be 
considered and thresholds for source tracking should be based solely 
upon the Category 1 and Category 2 limits for each source. The 
commenter noted that including sources because a licensee possesses a 
total number of sources that could exceed some arbitrary threshold 
would generate a great deal of confusion and not add to the security or 
control of materials. Total limits for sources in possession by 
licensees should be regulated by their individual licenses and not by 
the National Source Tracking System. Another commenter stated that 
clarification is needed to make it clear that the tracking system is 
for unique Category 1 or 2 sources and that a licensee's possession 
limit is not impacted by the rule.
    Response: NRC agrees with these comments. The proposed rule and 
this final rule do not contain reporting requirements based on 
aggregation of sources and the NRC has no plans to include such 
requirements on aggregation for the tracking system in the future. A 
specific threshold has been established and all sources at or above the 
threshold must be reported, regardless of a licensee's total 
possession. The threshold currently is Category 2. The National Source 
Tracking System does not affect possession limits.
    Comment L.10: Four commenters asked for clarification on decay and 
how decay of sources is handled as they go through the system and fall 
below the Category 2 threshold for tracking. Commenters requested 
information on how the tracking system will reconcile the transition. 
One commenter stated that reclassification of a source from Category 1 
to Category 2 due to decay should be recorded in the system. Three 
commenters stated that the system should automatically generate a 
notice when a source moves from a Category 1 to a Category 2 and when 
it decays below Category 2.
    Response: Decay of sources will automatically be calculated by the 
system based on the reported manufacture date or reported activity 
date. Once a source has decayed below the Category 2 threshold, it is 
no longer considered a nationally tracked source. A licensee will no 
longer be required to report transactions involving what is now 
considered a Category 3 source. The source status will be automatically 
changed from an active source to a decayed source, and the information 
on that source will be retained by the system. The licensee will be 
automatically notified that transactions on the source no longer need 
to be reported because the source has decayed below the threshold. The 
system will reclassify a source from Category 1 to Category 2 when it 
has decayed below the Category 1 threshold. However, no notifications 
are necessary because the reporting requirements are the same for 
Category 1 and Category 2 sources.
    Comment L.11: One commenter requested clarification on whether 
licensees will be required to reconstruct the inventory each year for 
the annual reconciliation and verification.
    Response: No, the NRC does not expect licensees to conduct a 
physical inventory as part of the reconciliation process. The 
expectation is that the inventory listing in the database will be 
compared to the inventory listing for the site and the licensee will 
either report that the database listing is correct or submit 
corrections as needed.
    Comment L.12: Three commenters noted that the tracking system will 
need to accommodate data entries for sources that are imported into 
this country which were manufactured and exported before the rule went 
into effect.
    Response: The reporting of the initial inventory for each licensee 
should account for all Category 1 and Category 2 sources in a 
licensee's possession. The origin of the source does not matter. NRC 
does not expect licensees to reconstruct a source's history. If a 
source is imported back to the United States, the source will be added 
to the system at that time.
    Comment L.13: One commenter stated that source transfers (including 
permanent transfers) between the same company but under different 
licenses should not be reported.
    Response: NRC disagrees with the commenter. Permanent transfers of 
sources do need to be reported. Transfers between temporary job sites 
do not need to be reported.
    Comment L.14: One commenter supported the assignment of unique 
serial numbers. The commenter stated that assignment of unique serial 
numbers is critical to ensure that the sources are properly managed 
throughout their use and at the end of their useful life.
    Response: No response is necessary.
    Comment L.15: One commenter stated that NRC should clarify whether 
the unity rule applies to an individual source with multiple 
radionuclides.
    Response: The unity rule does not apply to sources under the 
National Source Tracking System. Reporting is based on the activity 
level of the individual radionuclides in a source with multiple 
radionuclides. The sum of the fractions of each radionuclide does not 
need to be applied to the source.
    Comment L.16: Three commenters asked for clarification on how NRC 
plans to handle changes in serial numbers that occur when a source is 
installed into a source holder. The commenters noted that sources used 
in the oil and gas industry have serial numbers that are assigned by 
the manufacturer. However, after the source is permanently installed 
into a protective pressure vessel, the source holder is given a 
different serial number consistent with the end-user's nomenclature. 
The source is then tracked by the source holder serial number. The 
commenters recommended that the national source registry allow for 
these serial number changes in the life of a source. One of the 
commenters stated that NRC should be clear on the specific serial 
number that is tracked throughout the entire lifetime of a source.
    Response: The National Source Tracking System tracks a source using 
the manufacturer's assigned serial number in combination with the 
manufacturer and model number. An optional reporting element is a 
device serial number. On the paper form, the device number can be added 
to the

[[Page 65705]]

comment field. A licensee will be able to search (on-line) its own data 
by device number as well as the source number.
    Comment L.17: One commenter stated that the rule should address any 
potential SGI conflicts when sources are shipped as part of a 
Radioactive Material Quantities of Concern (RAMQC) shipment.
    Response: The NRC has reviewed the RAMQC requirements and has not 
identified any conflicts.

IV. Section by Section Analysis of Substantive Changes

Section 20.1003 Definitions

    A definition of nationally tracked sources is added to the 
regulations.

Section 20.2207 Reports of Transactions Involving Nationally Tracked 
Sources

    A new section is added to the regulations to require licensees to 
report to the National Source Tracking System transactions involving 
nationally tracked sources. Paragraph (a) requires the reporting of the 
manufacture of a nationally tracked source. Paragraph (b) requires the 
reporting of all transfers of nationally tracked sources to another 
authorized facility. Paragraph (c) requires the reporting of all 
receipts of a nationally tracked source. The final rule includes a new 
transaction for reporting disassembly of a nationally tracked source, 
this new requirement is in paragraph (d). Paragraph (e) requires the 
reporting of the disposal of any nationally tracked source. Each of 
these paragraphs requires the licensee to report specific information 
for the transaction, including source information such as the 
manufacturer, model, serial number, radioactive material, activity and 
activity date. The licensee must also provide the facility name, 
license number, name of the individual that prepared the report, and 
the transaction date. The final rule also requires reporting the 
address of the reporting licensee. If the transaction involves the use 
of the Uniform Low-Level Radioactive Waste Manifest, the licensee needs 
to report the waste manifest number and the container identification 
for the container with the source.
    Paragraph (f) requires licensees to report these transactions to 
the National Source Tracking System by the close of the next business 
day. The regulations allow the licensee to report the transactions 
either on-line, electronically using a computer-readable format, by 
facsimile, by mail, or by telephone.
    Paragraph (g) requires 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 is also required to reconcile and verify the 
information in the National Source Tracking System during the month of 
January each year. This process involves comparing the inventory 
information contained in the National Source Tracking System to the 
actual inventory possessed by the licensee. The amendment requires any 
discrepancies to be resolved by filing the reports identified by 
paragraphs (a) through (e) described above. The final rule clarifies 
that once the reconciliation is complete, licensees must submit 
confirmation that the data in the National Source Tracking System is 
correct. The reconciliation month has been changed from June to January 
in the final rule.
    Paragraph (h) requires a licensee to report its initial inventory 
of Category 1 nationally tracked sources by November 15, 2007, and the 
inventory of Category 2 nationally tracked sources by November 30, 
2007. These dates have been changed from the proposed rule. Source 
information such as the manufacturer, model, serial number, radioactive 
material, activity and activity date must be included. The licensee 
also needs to provide the facility name, license number, address, and 
name of the individual that prepared the report.

Appendix E Nationally Tracked Source Thresholds

    A new Appendix is added to part 20 that provides the thresholds for 
nationally tracked sources at the Category 1 and Category 2 levels. 
Radium-226 has been added to the Appendix and Pu-236, Pu-239, and Pu-
240 have been deleted from the Appendix. 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 is added to the 
regulations.

Section 32.201 Serialization of Nationally Tracked Sources

    A new section is 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.

Part 150

    The changes proposed for part 150 are not included in the final 
rule. The proposed rule changes to part 150 were intended for Agreement 
State licensees. With the change in basis for the rule from promotion 
of the common defense and security to protection of the public health 
and safety, Agreement State licensees no longer come under part 150 for 
the National Source Tracking System. Agreement States are required to 
issue legally binding requirements for their licensees. This could be 
done through promulgating a comparable rule, issuing orders, or adding 
or revising individual license conditions. The final rule is an 
immediate mandatory matter of compatibility. The Agreement States must 
issue the legally binding requirements such that the compliance dates 
for the final rule and the legally binding requirements are the same. 
This will ensure that both NRC and Agreement State licensees all begin 
reporting at the same time. The Agreement States will be responsible 
for implementation for their licensees, including inspection and 
enforcement.

V. Criminal Penalties

    For the purpose of Section 223 of the Atomic Energy Act (AEA), the 
Commission is amending 10 CFR parts 20 and 32 under one or more of 
Sections 161b, 161i, or 161o of the AEA. Willful violations of the rule 
will be subject to criminal enforcement.

VI. Agreement State Compatibility

    Under the ``Policy Statement on Adequacy and Compatibility of 
Agreement State Programs'' approved by the Commission on June 30, 1997, 
and published in the Federal Register on September 3, 1997 (62 FR 
46517), Sec.  20.2207, the final rule is classified as Compatibility 
Category ``B.'' The NRC program elements in this category are those 
that apply to activities that have direct and significant transboundary 
implications. An Agreement State should adopt program elements 
essentially identical to those of NRC. Agreement State and NRC 
licensees would report their transactions to the National Source 
Tracking System. The database would be maintained by NRC.

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

[[Page 65706]]

inconsistent with applicable law or otherwise impractical. In this 
final rule, the NRC requires licensees that possess, manufacture, 
transfer, receive, disassemble, 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 contains generally applicable 
requirements.

VIII. Environmental Impact: Categorical Exclusion

    The NRC has determined that this final rule is the type of action 
described as a categorical exclusion 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 
final rule.

IX. Paperwork Reduction Act Statement

    This final 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.). These requirements were approved by the 
Office of Management and Budget, approval numbers 3150-0014, 3150-0001, 
and 3150-0202.
    The burden to the public for the information collections in NRC 
Form 748 is estimated to average 10 minutes per response plus an 
annualized one-time burden of 80 hours per recordkeeper, the burden for 
the information collections in 10 CFR part 20 is estimated to average 1 
hour per response plus an annualize one-time burden of 8 hours per 
recordkeeper, and the burden for the information collections in 10 CFR 
part 32 is estimated to average 45 hours per recordkeeper. This 
includes the time for reviewing instructions, searching existing data 
sources, gathering and maintaining the data needed, and completing and 
reviewing the information collection. Send comments on any aspect of 
these information collections, including suggestions for reducing the 
burden, 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, 
(3150-0014, 3150-0001, and 3150-0202), Office of Management and Budget, 
Washington, DC 20503.

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.

X. Regulatory Analysis

    The Commission has prepared a regulatory analysis on this 
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 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 is reduced. The present value of the 
costs of the National Source Tracking System to the NRC is estimated to 
be $29.4 million and to industry is estimated to be $3.9 million in 
2006 dollars using a 3 percent discount rate. These estimated costs 
include the cost of development of the system and operation and 
maintenance through the year 2016.
    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.

XI. Regulatory Flexibility Certification

    In accordance with the Regulatory Flexibility Act of 1980 (5 U.S.C. 
605(b)), the Commission certifies that this rule does not have a 
significant economic impact on a substantial number of small entities.
    On the basis of information available to the Commission when the 
proposed rule was published, the Commission certified that the proposed 
rule, if adopted, would not have a significant impact on a substantial 
number of small entities. The Commission invited any small entity that 
determined that it is likely to bear a disproportionate economic impact 
because of its size to notify the Commission.
    The Commission did not receive any comments on the impact to small 
entities. The final rule affects about 350 NRC licensees and an 
additional 1,000 Agreement State licensees. Examples of 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 final 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 11,604 hours. Based on 
the regulatory analysis conducted for this action, the costs of the 
amendments for affected licensees are estimated to be $3.9 million 
total or on average about $2,889 per affected licensee. The NRC 
believes that the selected alternative reflected in the amendment is 
the least burdensome, most flexible alternative that would accomplish 
the NRC's regulatory objective.

XII. 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 final 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.

XIII. Congressional Review Act

    In accordance with the Congressional Review Act of 1996, the NRC 
has determined that this action is not a major rule and has verified 
this determination with the Office of Information and Regulatory 
Affairs of OMB.

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,

[[Page 65707]]

Radiation protection, Reporting and recordkeeping requirements.

0
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. 552 and 553, the NRC is adopting the 
following amendments to 10 CFR parts 20 and 32.

PART 20--STANDARDS FOR PROTECTION AGAINST RADIATION

0
1. The authority citation for part 20 is revised 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), Energy Policy Act 
of 2005, Pub. L. 109-58, 119 Stat. 594 (2005).

0
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 Category 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 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.
* * * * *

0
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 
3150-0202.

0
4. Section 20.2207 is added under Subpart M to read as follows:


Sec.  20.2207  Reports of transactions involving nationally tracked 
sources.

    Each licensee who manufactures, transfers, receives, disassembles, 
or disposes of a nationally tracked source shall complete and submit a 
National Source Tracking Transaction Report as specified in paragraphs 
(a) through (e) 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. The report must include the following information:
    (1) The name, address, and license number of the reporting 
licensee;
    (2) The name of the individual preparing the report;
    (3) The manufacturer, model, and serial number of 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. The report must include the following information:
    (1) The name, address, and license number of the reporting 
licensee;
    (2) The name of the individual preparing the report;
    (3) The 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. The 
report must include the following information:
    (1) The name, address, and license number of the reporting 
licensee;
    (2) The name of the individual preparing the report;
    (3) The name, address, 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 that disassembles a nationally tracked source 
shall complete and submit a National Source Tracking Transaction 
Report. The report must include the following information:
    (1) The name, address, and license number of the reporting 
licensee;
    (2) The name of the individual preparing the report;
    (3) The manufacturer, model, and serial number of the source or, if 
not available, other information to uniquely identify the source;
    (4) The radioactive material in the source;
    (5) The initial or current source strength in becquerels (curies);
    (6) The date for which the source strength is reported;
    (7) The disassemble date of the source.
    (e) Each licensee who disposes of a nationally tracked source shall 
complete and submit a National Source Tracking Transaction Report. The 
report must include the following information:
    (1) The name, address, and license number of the reporting 
licensee;
    (2) The name of the individual preparing the report;
    (3) The waste manifest number;
    (4) The container identification with the nationally tracked 
source.
    (5) The date of disposal; and
    (6) The method of disposal.
    (f) The reports discussed in paragraphs (a) through (e) 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

[[Page 65708]]

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.
    (g) 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. Such 
errors may be detected by a variety of methods such as administrative 
reviews or by physical inventories required by regulation. In addition, 
each licensee shall reconcile the inventory of nationally tracked 
sources possessed by the licensee against that licensee's data in the 
National Source Tracking System. The reconciliation must be conducted 
during the month of January 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 (e) of this section. By January 31 
of each year, each licensee must submit to the National Source Tracking 
System confirmation that the data in the National Source Tracking 
System is correct.
    (h) Each licensee that possesses Category 1 nationally tracked 
sources shall report its initial inventory of Category 1 nationally 
tracked sources to the National Source Tracking System by November 15, 
2007. 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 November 30, 
2007. The information may be submitted by using any of the methods 
identified by paragraph (f)(1) through (f)(4) of this section. The 
initial inventory report must include the following information:
    (1) The name, address, and license number of the reporting 
licensee;
    (2) The name of the individual preparing the report;
    (3) The manufacturer, model, and serial number of each nationally 
tracked source or, if not available, other information to uniquely 
identify the source;
    (4) The radioactive material in the sealed source;
    (5) The initial or current source strength in becquerels (curies); 
and
    (6) The date for which the source strength is reported.

0
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 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-238...................................              60           1,600            0.6            16
Plutonium-239/Be................................              60           1,600            0.6            16
Polonium-210....................................              60           1,600            0.6            16
Promethium-147..................................          40,000       1,100,000          400          11,000
Radium-226......................................              40           1,100            0.4            11
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

0
6. The authority citation for part 32 is revised 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), Energy Policy Act of 2005, Pub. L. No. 109-58, 
119 Stat. 594 (2005).

0
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 Category 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 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.

0
8. In Sec.  32.8, paragraph (b) is revised to read as follows:


Sec.  32.8  Information collection requirements: OMB approval.

* * * * *

[[Page 65709]]

    (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.

0
9. Section 32.201 is added under Subpart D to read as follows:

Subpart D--Specifically Licensed Items


Sec.  32.201  Serialization of nationally tracked sources.

    Each licensee who manufactures a nationally tracked source after 
February 6, 2007 shall assign a unique serial number to each nationally 
tracked source. Serial numbers must be composed only of alpha-numeric 
characters.

    Dated at Rockville, Maryland, this 1st day of November, 2006.

    For the Nuclear Regulatory Commission.
Annette Vietti Cook,
Secretary of the Commission.
 [FR Doc. E6-18713 Filed 11-7-06; 8:45 am]
BILLING CODE 7590-01-P