[Federal Register Volume 74, Number 147 (Monday, August 3, 2009)]
[Proposed Rules]
[Pages 38372-38381]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-18438]



[[Page 38372]]

=======================================================================
-----------------------------------------------------------------------

NUCLEAR REGULATORY COMMISSION

10 CFR Part 31

RIN 3150-AI33
[NRC-2008-0272]


Limiting the Quantity of Byproduct Material in a Generally 
Licensed Device

AGENCY: Nuclear Regulatory Commission.

ACTION: Proposed rule.

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

SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) is proposing to 
amend its regulations to limit the quantity of byproduct material 
contained in a generally licensed device to below one-tenth (1/10) of 
the International Atomic Energy Agency (IAEA) Category 3 thresholds. As 
a result of this amendment, individuals possessing devices with 
byproduct material meeting or exceeding these thresholds would be 
required to apply for and obtain a specific license. The NRC is also 
proposing to further clarify the requirements that apply when a device 
authorized to be used under the general license is instead held under a 
specific license. The proposed amendments would also modify the 
Compatibility Categories contained in the current regulations.

DATES: Submit comments on the rule by October 19, 2009. Submit comments 
specific to the information collection aspects of this rule by 
September 2, 2009. Comments received after the above date will be 
considered if it is practical to do so, but the NRC is able to ensure 
consideration only for comments received on or before this date.

ADDRESSES: You may submit comments on the rule by any one of the 
following methods. Please include the Docket ID NRC-2008-0272 in the 
subject line of your comments. Comments submitted in writing or in 
electronic form will be posted on the NRC Web site and on the Federal 
rulemaking Web site Regulations.gov. Because your comments will not be 
edited to remove any identifying or contact information, the NRC 
cautions you against including any information in your submission that 
you do not want to be publicly disclosed.
    The NRC requests that any party soliciting or aggregating comments 
received from other persons for submission to the NRC inform those 
persons that the NRC will not edit their comments to remove any 
identifying or contact information, and therefore, they should not 
include any information in their comments that they do not want 
publicly disclosed.
    Federal Rulemaking Web site: Go to http://www.regulations.gov and 
search for documents filed under Docket ID NRC-2008-0272. Address 
questions about NRC dockets to Carol Gallagher at 301-492-3668, e-mail: 
[email protected].
    Mail comments to: Secretary, U.S. Nuclear Regulatory Commission, 
Washington, DC 20555-0001, ATTN: Rulemakings and Adjudications Staff.
    E-mail comments to: [email protected]. If you do not 
receive a reply e-mail confirming that we have received your comments, 
contact us directly at 301-415-1677.
    Hand-deliver comments to: 11555 Rockville Pike, Rockville, Maryland 
20852, between 7:30 a.m. and 4:15 p.m. on Federal workdays. (Telephone 
301-415-1677)
    Fax comments to: Secretary, U.S. Nuclear Regulatory Commission at 
301-415-1101. You may submit comments on the information collections by 
the methods indicated in the Paperwork Reduction Act Statement.
    You can access publicly available documents related to this 
proposed rule using the following methods:
    NRC's Public Document Room (PDR): The public may examine and have 
copied for a fee publicly available documents at the NRC's PDR, Public 
File Area O-1 F21, One White Flint North, 11555 Rockville Pike, 
Rockville, Maryland 20852.
    NRC's Agencywide Document Access and Management System (ADAMS): 
Publicly available documents created or received at the NRC are 
available electronically at the NRC's Electronic Reading Room at: 
http://www.nrc.gov/reading-rm/adams.html. From this page, the public 
can gain entry into ADAMS, which provides text and image files of NRC's 
public documents. If you do not have access to ADAMS or if there are 
problems in accessing the documents located in ADAMS, contact the NRC's 
PDR Reference staff at 1-800-397-4209, 301-415-4737, or by e-mail to 
[email protected].
    Federal Rulemaking Web site: Public comments and supporting 
materials related to this proposed rule can be found at http://www.regulations.gov by searching on Docket ID NRC-2008-0272.

FOR FURTHER INFORMATION CONTACT: Solomon Sahle, Office of Federal and 
State Materials and Environmental Management Programs, U.S. Nuclear 
Regulatory Commission, Washington, DC 20555-0001, telephone (301) 415-
3781, e-mail: [email protected].

SUPPLEMENTARY INFORMATION:

I. Background
II. Discussion
    A. Rationale for Limiting the Quantity of Byproduct Material in 
a Generally Licensed Device
    B. Decision on Proposed Amendment To Place a Limit on Quantity 
of Byproduct Material in Generally Licensed Devices
    C. Specific Licensees and Generally Licensed Devices
    D. Specific Questions for Comment
    E. Implementation of the Proposed Rule Amendments
III. Discussion of Proposed Amendments by Section
IV. Criminal Penalties
V. Agreement State Compatibility
VI. Plain Language
VII. Voluntary Consensus Standards
VIII. Environmental Impact: Categorical Exclusion
IX. Paperwork Reduction Act Statement Public Protection Notification
X. Regulatory Analysis
XI. Regulatory Flexibility Certification
XII. Backfit Analysis

I. Background

    Prior to the terrorist attacks of September 11, 2001 (9/11), 
several national and international efforts were underway to address the 
potentially significant health and safety hazards posed by uncontrolled 
sources. These efforts recognized the need for increased control of 
high-risk radioactive materials to prevent inadvertent and intentional 
unauthorized access, primarily due to the potential health and safety 
hazards posed by the uncontrolled material. Following 9/11, these 
efforts were expanded to include a heightened awareness and increased 
focus on the need to prevent intentional unauthorized access due to 
potential malicious acts. These efforts, such as the IAEA Code of 
Conduct on the Safety and Security of Radioactive Sources (Code of 
Conduct) concerning Category 1 and Category 2 sources, seek to increase 
the control over sources to prevent unintended radiation exposure and 
to prevent malicious acts. Proper security and control measures reduce 
the likelihood of intentional unauthorized access that could result in 
this radioactive material being used in radiological dispersal devices 
(RDD) or in radiological exposure devices (RED).
    In June 2002, the Secretary of Energy and the NRC Chairman met to 
discuss the adequate protection 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 working group issued its

[[Page 38373]]

report ``Radiological Dispersal Devices: An Initial Study To Identify 
Radioactive Materials of Greatest Concern and Approaches to Their 
Tracking, Tagging, and Disposition.''
    The NRC also supported U.S. Government efforts to establish 
international guidance for the safety and security of radioactive 
materials of concern, which resulted in a major revision of the IAEA 
Code of Conduct. The IAEA Board of Governors approved the revised Code 
of Conduct in September 2003; it is available on the IAEA Web site at: 
http://www-pub.iaea.org/MTCD/publications/PDF/Code-2004_web.pdf. In 
particular, the Code of Conduct contains a recommendation that each 
IAEA Member State develop a national source registry of radioactive 
sources that includes as a minimum Category 1 and Category 2 
radioactive sources as described in Annex 1 of the Code of Conduct. 
Annex 1 of the Code of Conduct source registry recommendation addressed 
16 radionuclides.
    The DOE/NRC joint report paralleled the work on the Code of Conduct 
and the development of IAEA TECDOC-1344, ``Categorization of 
Radioactive Sources.'' (Section A.4.1 of this document contains a 
description of the IAEA source categorization system.) The IAEA updated 
this categorization system for radioactive sources in August 2005, in 
the IAEA Safety Standards Series No. RS-G-1.9 ``Categorization of 
Radioactive Sources.'' The Safety Guide is available on the IAEA's Web 
site at http://www-pub.iaea.org/MTCD/publications/PDF/Pub1227_web.pdf 
and 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 
radionuclide-specific activity levels (D values) as normalizing 
factors; the D values are used for emergency planning and response. The 
quantities of concern identified in the May 2003 DOE/NRC report are 
similar to the IAEA Code of Conduct Category 2 threshold values, and 
therefore, to allow alignment between domestic and international 
efforts to increase the safety and security of radioactive sources, the 
NRC has adopted the Category 2 definitions contained in the IAEA's Code 
of Conduct. The NRC considers IAEA Category 2 quantities (and higher) 
to be risk-significant radioactive material that has a potential to 
result in significant adverse impacts that could reasonably constitute 
a threat to the public health and safety, the environment, or the 
common defense and security of the United States (U.S.).
    While the various efforts and reviews previously noted in this 
notice have been ongoing, the NRC also implemented several measures to 
increase the safety and security of radioactive sources, with 
particular focus on radioactive sources of concern. These measures 
included the issuance of increased controls orders to specific 
licensees who possess IAEA Category 1 and Category 2 radioactive 
sources (70 FR 72128; December 1, 2005). The orders required these 
licensees to exercise added control over these sources. In addition, 
the NRC increased the frequency of inspections to further ensure that 
there is adequate control of these materials. The NRC also published a 
final rule in November 2006 that established a National Source Tracking 
System (NSTS) to provide better accountability and control over 
Category 1 and Category 2 sources. The NRC proposed, in a separate 
rulemaking (73 FR 19749; April 11, 2008), to expand the NSTS to include 
sources equal to, or greater than, 1/10 of the IAEA Category 3 
threshold values to address accountability of these sources and 
concerns over potential malevolent aggregation of these lower activity 
sources to IAEA Category 2 levels. (Note: Sources referred to as ``1/10 
of Category 3'' were formerly referred to as ``Category 3.5'' sources 
in these documents. To be consistent with IAEA terminology, the term 
``Category 3.5'' has been changed to ``1/10 of Category 3.''). The NRC 
staff evaluated the comments received on this proposed rule and, in 
SECY-09-0086 dated June 10, 2009, requested approval from the 
Commission to publish the final rule in the Federal Register. Staff's 
recommendation in SECY-09-0086 was to expand the NSTS to Category 3 
sources instead of 1/10 of Category 3. In a Staff Requirements 
Memorandum (SRM) dated June 30, 2009, the Commission stated that it was 
unable to reach a decision on the staff's recommendation and therefore 
did not approve publication of the NSTS Expansion final rule.
    During this time, there has been increased concern regarding 
devices that are currently possessed under NRC's general license (GL) 
regulatory program. The requirements for general licensees are 
described in 10 CFR Part 31, ``General Domestic Licenses for Byproduct 
Material.'' The U.S. Congress and the U.S. Government Accountability 
Office (GAO) raised concerns regarding the safety and security of 
radioactive material covered by the GL regulatory system and the 
Organization of Agreement States (OAS) filed a petition for rulemaking 
on June 27, 2005 (PRM-31-5), requesting that the NRC strengthen its GL 
regulatory system. The NRC staff has been considering similar issues, 
including that under the current GL regulatory system, the NRC and the 
Agreement States do not have an opportunity to review the purpose of 
use, adequacy of applicant facilities and equipment, training and 
experience, and the ability to meet any other applicable requirements 
for those that possess GL devices. Further, a licensee's loss of 
control of radioactive sources, whether it be inadvertent or through a 
deliberate act, could result in significant adverse health impacts, 
which could constitute a threat to the public health and safety. Thus, 
the NRC has been considering whether it is appropriate to amend 10 CFR 
Part 31 to require specific licensing for some materials currently 
regulated under the GL regulatory system. Limiting the source activity 
allowed under a GL would result in more specifically licensed devices, 
which would be regulated under 10 CFR Part 30, ``Rules of General 
Applicability to Domestic Licensing of Radioactive Material.''

II. Discussion

    In this rulemaking, the NRC is proposing to amend its regulations 
to limit the quantity of byproduct material allowed in a generally 
licensed device. The proposed amendment to the NRC's regulations would 
limit the quantity of certain byproduct material allowed in a generally 
licensed device to below 1/10 of the IAEA's Category 3 thresholds; 
licensees with devices containing byproduct material at or above this 
limit would be required to obtain a specific license (SL). This 
rulemaking is directed toward improving the safety and security of 
devices now held under GL containing radioactive sources falling within 
IAEA Categories 3 through 5 by causing a portion of them to be 
specifically licensed allowing the remaining portion to continue to be 
used under general license.
    In determining whether to place a limit on the quantity of 
byproduct material allowed in a generally licensed device, the NRC has 
considered the need to balance the secure handling and use of the 
materials without discouraging the beneficial use of GL devices 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

[[Page 38374]]

procedures; and are used in technology research and development 
involving academic, government, and private institutions. These 
materials are as diverse in geographical location as they are in 
functional use.
    Placing a limit on the quantity of byproduct material allowed in a 
generally licensed device is part of a comprehensive control program 
for radioactive materials of greatest concern, as discussed in SECY-07-
0147, ``Response to U.S. Government Accountability Office 
Recommendations and Other Recommendations to Address Security Issues in 
the U.S. Nuclear Regulatory Commission Materials Program,'' dated 
August 25, 2007. Although this proposed amendment cannot by itself 
ensure the physical protection of sources, converting certain devices 
from use under a GL to use under an SL can provide greater device 
accountability and, as part of an overall effort in conjunction with 
other related activities (e.g., potential applicability of the NSTS, 
Web-based licensing, pre-licensing site visits, and increased controls 
orders), can improve the control of radioactive sources and protect 
public health and safety, as well as common defense and security.
    This rulemaking also considers the issues raised by the OAS in its 
June 27, 2005, petition for rulemaking, in which it requested that the 
NRC revise 10 CFR 31.5 and change the Compatibility Category of 10 CFR 
31.6 from ``B'' to ``C.'' The rulemaking also considers the issues 
raised by the State of Florida in its June 3, 2005, request to change 
the Compatibility Category of 10 CFR 31.5(c)(13)(i) from ``B'' to 
``C.'' These issues were docketed by the NRC as PRM-31-5.
    The following sections of this statement of considerations discuss 
the rationale for placing a limit on the quantity of byproduct material 
in a generally licensed device (Section A) and the NRC's decision on 
the approach in this proposed amendment (Section B).

A. Rationale for Limiting the Quantity of Byproduct Material in a 
Generally Licensed Device

A.1 Congressional Concerns/GAO Investigations
    The U.S. Senate and the GAO have expressed concerns regarding the 
safety and security of radioactive sources. In a report by the 
Permanent Subcommittee on Investigations (PSI), July 12, 2007, the 
subcommittee expressed concerns about certain U.S. Government practices 
and procedures for issuing licenses to possess radioactive materials 
and presented recommendations that would remedy their concerns. The GAO 
completed two investigations of the security aspects of NRC's materials 
licensing process, including one in 2007 (GAO-07-1038T, July 12, 2007) 
on the security of the NRC licensing process. In its report, the GAO 
raised concerns about the relative ease with which lower activity 
sources can be purchased and potentially aggregated to higher activity 
levels.
A.2 Agreement State Issues
    Agreement States have also raised concerns about the security and 
accountability of byproduct materials in generally licensed devices. In 
its June 27, 2005, petition for rulemaking, the OAS requested that NRC 
``strengthen the regulation of radioactive materials by requiring a 
specific license for higher-activity devices that are currently 
available under the general license in 10 CFR 31.5.'' Specifically, the 
petition requested that the NRC amend its regulations to require 
specific licensing for devices exceeding the registration quantity 
limits in 10 CFR 31.5(c) (13)(i). Additionally, the OAS requested that 
NRC revise the compatibility designation of 10 CFR 31.6 from ``B'' to 
``C'' which would allow States to better track service providers and 
distributors of generally licensed devices. In addition, the State of 
Florida also requested a compatibility category change for 10 CFR 
31.5(c)(13)(i) from ``B'' to ``C'' to allow the State to continue to 
require registration of other generally licensed devices in addition to 
those currently registered by the NRC. These petitions were docketed by 
NRC as PRM-31-5. The NRC requested public comment on PRM-31-5 on 
December 20, 2005 (70 FR 75423). Four comment letters were received on 
the petition; the commenters disagreed with using the registration 
levels to require general licensees to become specific licensees but 
had differing views on changing the compatibility categories. In 
considering the petition and the public comments, the NRC decided to 
consider the concerns and issues raised by OAS and the State of Florida 
in this rulemaking. By letter dated August 17, 2007, the petitioners 
were informed of this decision.
A.3 Recent NRC Actions
    On April 24, 2006, the NRC staff submitted SECY-06-0094, ``Tracking 
or Providing Enhanced Controls for Category 3 Sources,'' to the 
Commission for review. In that paper, the NRC staff proposed initiating 
a rulemaking that would set activity limits for general licensees at 
one-half (\1/2\) of the IAEA Category 2 threshold and reserve 
authorization to possess higher activity sources to specific licensees. 
The staff noted that a benefit of setting such a limit would be greater 
oversight of these licensees, allowing regulatory bodies the 
opportunity to perform an assessment of a licensee's legitimacy or any 
other regulatory activities the Commission determined to be necessary. 
The NRC staff, in SECY-06-0094, recommended setting the GL limit at \1/
2\ of Category 2 because the activity levels in such devices would be 
close to the Category 2 levels and such a limit would not affect a 
significant number of licenses.
    In response to SECY-06-0094, the Commission, in a Staff 
Requirements Memorandum (SRM), dated June 9, 2006, approved the staff's 
plan to amend the GL requirements in 10 CFR 31.5, but disapproved the 
staff's recommendation to set the limit at \1/2\ of IAEA Category 2. 
Instead, the Commission approved moving forward to evaluate requiring 
specific licensing of general licensees possessing devices greater than 
or equal to \1/10\ of the IAEA's Category 3 threshold.
A.4 Considerations Regarding the Need for Placing a Limit on the 
Quantity of Byproduct Material Allowed in a Generally Licensed Device, 
and Determining What the ``Limit'' Should Be
    This section briefly describes the IAEA source characterization 
system (Section A.4.1); the existing GL regulatory system (Section 
A.4.2); and the specific rationale for revising the existing GL 
regulatory system to place a limit on the quantity of byproduct 
material in a generally licensed device (Section A.4.3).
A.4.1 The Five IAEA Categories and the Relative Health and Safety Risk 
Posed by Sources in Those Categories
    The IAEA source categorization scheme includes five categories. 
These categories are based on the potential for sources to cause health 
effects to persons exposed to them. Sources in Category 1 are 
considered to be the most dangerous because they can pose a very high 
risk to human health if not managed safely and securely. At the lower 
end of the categorization system, sources in Category 5 are the least 
dangerous, but even these sources could give rise to doses in excess of 
the dose limits if not properly controlled. Based on analysis of 
potential health effects, each of the IAEA Categories contain 
radioactive material in sealed sources in quantities that can be 
characterized as follows:

[[Page 38375]]

    Category 1: Greater than or equal to the Category 1 threshold 
(e.g., for Cobalt-60 (Co-60): 810 Curies (Ci)); these sources are 
typically used in irradiators, radiation therapy, and radiothermal 
generators;
    Category 2: Less than the Category 1 threshold but equal to or 
greater than the Category 2 threshold (which is \1/100\ of Category 1; 
e.g., for Co-60: 8.1 Ci); these sources are typically used in 
industrial gamma radiography and high and medium dose rate 
brachytherapy;
    Category 3: Less than the Category 2 threshold but equal to or 
greater than the Category 3 threshold (\1/10\ of Category 2; e.g., for 
Co-60: 0.81 Ci); these sources are typically used in fixed industrial 
gauges involving high activity sources;
    Category 4: Less than the Category 3 threshold but equal to or 
greater than the Category 4 threshold (\1/100\ of Category 3; e.g., for 
Co-60: 0.0081 Ci); and
    Category 5: Less than the Category 4 threshold down to IAEA exempt 
quantities.
A.4.2 The Existing GL Regulatory System in 10 CFR Part 31 and Its 
Rationale
    The primary elements of the existing GL regulatory framework are 
contained in 10 CFR Part 31. A generally licensed device usually 
consists of byproduct material contained in a sealed source within a 
shielded housing. The device is designed with inherent radiation safety 
features so that it can be used by persons with no radiation training 
or experience. Thus, the GL regulatory program simplifies the licensing 
process because a case-by-case determination of the adequacy of the 
radiation training or experience of each user is not necessary. As part 
of the GL regulatory system, the NRC evaluates the adequacy of 
generally licensed products by ensuring that manufacturers and 
distributors of the products (all of whom hold specific licenses) meet 
the various specific requirements in Subpart B to 10 CFR Part 32. 
Although there is no limit specified in the existing GL regulatory 
system regarding the quantity of byproduct material that can be allowed 
in a device and still continue to be generally licensed, at this time 
all of the generally licensed devices are in IAEA Categories 3 through 
5 (i.e., there are no Category 1 or Category 2 generally licensed 
devices currently in existence).
    As part of the current GL regulatory system, 10 CFR 31.5 contains 
requirements that certain generally licensed devices containing 
byproduct material in quantities above ``registration'' levels listed 
in 10 CFR 31.5(c)(13)(i) must be registered annually with the NRC. 
There are about 1,200 general licensees possessing such devices who are 
currently registered with the NRC. The radionuclides listed in 10 CFR 
31.5(c)(13)(i) are Co-60, Cesium-137, Strontium-90, Radium-226, 
Americium-241, and any other transuranics. As an example, the 
registration level for Co-60 is 0.001 Ci; which falls in the IAEA 
Category 5 range and is approximately \1/1000\ of the IAEA Category 3 
threshold for Co-60 (and approximately \1/10\ of the Category 4 
threshold).
    The GL registration program was initiated in rule amendments 
finalized on August 4, 1999 (64 FR 42269), and December 18, 2000 (65 FR 
79162). As noted in the Federal Register notice (FRN) for the August 4, 
1999, rulemaking, the GL registration program is primarily intended to 
ensure that general licensees are aware of and understand the 
requirements for the possession of devices containing byproduct 
materials, and that such devices are maintained and transferred 
properly and not inadvertently discarded. In initiating the GL 
registration program, the NRC noted that it was most concerned about 
generally licensed devices that had not been handled or disposed of 
properly and believed that if general licensees were made aware of 
their responsibilities, they would be more likely to comply with the 
requirements for proper handling and disposal of generally licensed 
devices. Additional compliance with these requirements would help 
reduce the potential for incidents, including those related to sources 
not disposed of properly and accidently melted in steel mills, which 
can cause unnecessary radiation exposure and property contamination.
A.4.3. Rationale for Revising the Existing GL Regulatory System and 
Placing a Limit on the Quantity of Radioactivity Allowed in a Generally 
Licensed Device
    In preparing this proposed rule, the NRC has determined that there 
is a need to enhance the security and accountability for devices with 
certain lower activity sources. The issues the NRC considered in this 
rulemaking include:
    (1) Whether to modify the existing GL regulatory system by placing 
a limit on the quantity of byproduct material allowed in generally 
licensed devices; and
    (2) The appropriate value for the limit, i.e., should the limit be 
set at \1/10\ of the IAEA Category 3 threshold (as suggested in the 
June 9, 2006 SRM) or should it be set lower to include devices that are 
above the current registration levels which are at a level 
approximately \1/1000\ of the IAEA Category 3 threshold (as suggested 
in the June 27, 2005 OAS petition for rulemaking).
    The rationale for modifying the existing GL regulatory system and a 
discussion of the selection of the \1/10\ of Category 3 threshold are 
provided in Sections A.4.3.1 and A.4.3.2, respectively, of this 
document.
A.4.3.1 Rationale for Revising the GL Regulatory System To Require 
Generally Licensed Devices Above a Certain Limit To Become Specific 
Licenses
    As part of its overall process, the NRC evaluated its current GL 
regulatory system, as described in Section A.4.2 of this document, and 
found that the relatively few administrative or operational regulatory 
constraints (mainly as a result of the safety features incorporated 
into their design), imposed on GL devices raise a number of concerns 
about security vulnerabilities. Under the current GL regulatory system, 
a general licensee would not be subject to the same regulatory controls 
(i.e., pre-licensing reviews, inspection, safety and security 
requirements) as specific licensees possessing similar quantities of 
radioactive material. Placing certain generally licensed devices under 
the SL process would subject them to elements of oversight that are not 
part of the GL process, including the license application and review 
process, and more routine inspections and elements of security 
requirements. The SL regulatory controls would improve not only the 
ability to prevent any theft or diversion of these materials, but would 
also help prevent or detect any inadvertent loss of such devices that 
could potentially impact public health and safety.
    Further, requiring a specific license for some generally licensed 
devices would provide an opportunity for a detailed review of the 
radioactive materials program proposed by an applicant, an opportunity 
for oral and written dialogue with the applicant, and a regulatory 
decision as to whether to grant the license as requested, or if certain 
modifications are necessary. Specifically, this amendment would allow 
for a more rigorous screening of applicants through pre-licensing 
visits to the proposed location of licensed activities (currently under 
consideration); a more efficient licensing process to facilitate the 
rapid communication between regulators regarding the legitimacy of a 
given entity; and other potential

[[Page 38376]]

enhancements to the specific licensing process.
    The NRC does not routinely perform inspections of general 
licensees. Inspections of general licensees are only performed in 
certain circumstances, such as when there are indications of unsafe 
practices by the general licensees. By converting certain general 
licensees to specific licensees, the effectiveness of any applicable 
safety and security measures could be accurately determined in a more 
timely manner if needed. The SL inspection program is implemented by 
the NRC and Agreement States in a risk-informed manner (e.g., 
inspection frequency is commensurate with the scope and complexity of 
the licensed activity and the quantity and type/form of radioactive 
material authorized by the license) and by use of performance-based 
inspections, which focus on the program outcomes achieved by the 
licensee and then probe (through interview, observation, and reviews of 
selected records) where needed and appropriate to understand the basis 
for each outcome.
A.4.3.2 Specific Rationale for Determining the Limit on the Quantity of 
Radioactivity Allowed in a Generally Licensed Device
    As noted in Section A.4.3 of this document, the NRC considered the 
appropriate value to limit the quantity of byproduct material allowed 
in a generally licensed device. The Commission's June 9, 2006 SRM 
directed the staff to evaluate specific licensing at \1/10\ of the IAEA 
Category 3 thresholds, whereas the OAS, in its June 27, 2005 petition, 
requested that the limit be set at a lower level to include devices 
that are at or above the current registration levels (approximately \1/
1000\ of the IAEA Category 3 threshold). Considerations as to what 
level to set the limit are based on the potential for aggregation to 
higher activity quantities of concern and also on the additional 
resource burden placed on licensees and on the regulatory bodies which 
would result from such an amendment.
A.4.3.2.1 Potential for Aggregation to Higher IAEA Categories of 
Concern for Devices With Sources at or Above \1/10\ of the IAEA 
Category 3 Thresholds
    Converting certain devices with sources that are equal to or 
greater than \1/10\ of Category 3 to specific licenses would involve 
sources in Category 3 itself, as well as a subset of IAEA Category 4 
sources (i.e., sources at the ``high end'' of the Category 4 
radioactivity range that are equal to, or greater than, \1/10\ of the 
Category 3 threshold). These two groups are discussed below.
    Category 3 sources are defined by IAEA as ``dangerous sources''--
i.e., sources that could, if not under control, give rise to exposure 
sufficient to cause severe deterministic effects, and thus even without 
any aggregation there is rationale for specifically licensing devices 
with Category 3 sources. Further, devices with Category 3 sources could 
be easily aggregated to Category 2 levels because they contain sources 
with activity levels that range from just below the Category 2 
threshold down to \1/10\ of the Category 2 threshold. Thus, sources at 
the high end of the range of activities in Category 3 can be at levels 
just below the threshold of a Category 2 source, meaning that it would 
take only a few of these devices with such sources to aggregate to 
Category 2. The major category of licensees who possess devices with 
Category 3 sources include those with industrial gauges and, because 
these devices are relatively widespread in use and relatively broadly 
used in industry, there is potential for aggregation of sufficient 
numbers of them to Category 2 levels.
    With regard to devices with sources that are \1/10\ of IAEA 
Category 3, these are actually a subset of IAEA Category 4 sources that 
are in the high end of the Category 4 radioactivity range. A principal 
rationale for including sources at the high-end of the Category 4 range 
of activities (at \1/10\ of Category 3) is the potential that a 
sufficient number of devices with these higher-activity Category 4 
sources could be obtained and aggregated to create the equivalent of 
Category 2 sources. These ``high-end'' Category 4 sources can be at 
levels just below the threshold of a Category 3 source, which is about 
\1/10\ of the threshold of a Category 2 source, meaning that it would 
require about 10-12 of these devices with such sources to aggregate to 
Category 2 quantities. Devices with these high-end Category 4 (\1/10\ 
Category 3) sources are possessed by similar licensees noted to have 
Category 3 sources, namely those with industrial gauges, and, as 
previously noted, are in relatively widespread use and broadly used in 
industry, thus allowing for the potential for aggregation of sufficient 
numbers of them to IAEA Category 2 levels.
    For Devices With Sources That Are at or Above Registration Levels:
    As noted above, the OAS in its June 27, 2005, petition requested 
that the GL limit be set at a level that would include devices with 
sources that are at or above the current registration levels, which are 
approximately \1/1000\ of the IAEA Category 3 threshold. The Commission 
has considered this level, which would include devices with sources in 
all of the IAEA Category 4 radioactivity range (i.e., including those 
in the ``low-end'' of the Category 4 radioactivity range) and also all 
devices with sources in IAEA Category 5. In general, these categories 
are so low that hundreds or thousands of devices with such sources 
would need to be aggregated to constitute a radioactive source in a 
quantity of concern. In view of the lower likelihood that devices with 
sources in the lower range of Category 4 or in Category 5 would be 
aggregated to quantities of concern, the staff believes that the 
relatively low security risk does not justify the significant 
regulatory resources and impacts on licensees that would result from 
specifically licensing devices with sources in the lower Category 4 and 
Category 5 ranges.
A.4.3.2.2 Consideration of the Additional Resource Burden on Licensees 
and Regulatory Bodies To Comply With These Proposed Amendments
    Requiring certain general licensees to obtain specific licenses 
would result in increased burden on licensees, and on the NRC and 
Agreement States, for preparation and review of specific license 
applications and amendments and for conducting inspections. In the 
Regulatory Analysis for this rulemaking (see Section X of this 
document), the Commission provides an analysis of the additional costs 
and benefits of placing a limit on the quantity of radioactivity 
allowed in a generally licensed device. A summary of the analysis 
follows.
    For Devices With Sources at or Above \1/10\ of the IAEA Category 3 
Thresholds:
    Limiting the quantity of byproduct material allowed in generally 
licensed devices to below \1/10\ of the IAEA's Category 3 thresholds 
would result in approximately 280 NRC general licensees being converted 
to specific licensees (approximately 1400 NRC and Agreement State 
general licensees). These licensees would now have to follow existing 
NRC requirements including 10 CFR Parts 19, 20, and 30. The added 
number of specific licensees would also result in an increase in the 
regulatory resources that would be devoted to reviewing the new SL 
applications and inspecting the licensees after the license is issued. 
However, the NRC and Agreement State resources incurred are not 
considered significant because the number of additional general 
licensees that would be converted to specific licensees represent only 
about 6 percent of the NRC and Agreement States existing population of 
specific licensees and,

[[Page 38377]]

hence, would not result in significant additional NRC and/or Agreement 
States resource commitment.
    For Devices With Sources at or Above Registration Levels:
    Limiting the quantity of byproduct material allowed in generally 
licensed devices to registration levels would result in approximately 
1,200 NRC general licensees being converted to specific licensees 
(approximately 6,000 NRC and Agreement State general licensees), these 
licensees, possessing Category 4 and upper-end Category 5 sources, 
would now have to follow existing NRC requirements including 10 CFR 
Parts 19, 20, and 30. The added number of specific licensees would 
result in an increase in the regulatory resources that would need to be 
devoted to reviewing the new SL applications and inspecting the 
licensees after the license is issued. It is estimated that the number 
of additional general licensees that would be converted into specific 
licensees represent about 25 percent of the NRC and Agreement States 
existing population of specific licensees and, hence, would represent a 
relatively significant additional NRC and/or Agreement States resource 
commitment. In view of the lower likelihood that devices with sources 
in the lower range of Category 4 or in Category 5 would be aggregated 
to quantities of concern, the staff believes that the relatively low 
security risk does not justify the significant regulatory resources and 
impacts on licensees that would result from specifically licensing 
devices with sources in the lower Category 4 and Category 5 ranges.

B. Decision on Proposed Amendment To Place a Limit on the Quantity of 
Byproduct Material Allowed in Generally Licensed Devices

    Based on the considerations of Section II.A of this document, the 
NRC has decided to propose amending its regulations by limiting the 
quantity of byproduct material that can be in a generally licensed 
device to \1/10\ of the IAEA Category 3 threshold. The regulatory text 
is based on the existing text of Appendix E to 10 CFR Part 20, i.e., 
with the limit ``less than \1/100\ of the thresholds listed in Appendix 
E to 10 CFR Part 20 for Category 2.''
    The basis for this limit is discussed in Section A of this 
document. In sum, the NRC believes that the additional security and 
safety provided by the specific licensing process is necessary to limit 
the potential for aggregating Category 3 and high-end Category 4 
radioactive sources to IAEA Category 2 quantities of concern. The NRC 
believes that the additional burden to licensees and regulatory bodies 
that would result from the proposed amendments is reasonable because of 
the enhanced public health and safety and security derived from placing 
these higher activity generally licensed devices under a greater range 
of regulatory controls.
    The need for this proposed amendment to the GL regulatory system 
was not foreseen in 1999 and 2000 when NRC issued the rule amendments 
instituting the GL registration system. As noted in Section A.4.2 of 
this document, and in the Statements of Considerations for those rule 
amendments, the principal rationale for the GL registration program was 
to make general licensees more aware of applicable requirements, hence 
reducing the potential for improper handling or disposal of devices due 
to lack of knowledge or inadvertent misuse, and the belief that if 
general licenses are aware of their responsibilities they will comply 
with requirements for proper handling and disposal of generally 
licensed devices. The current rulemaking seeks to reflect the changed 
domestic and international threat environments, and related U.S. 
Government-supported international initiatives in the nuclear security 
area, by setting an upper limit for licensing of generally licensed 
devices at \1/10\ of IAEA Category 3 for certain isotopes listed in 
Appendix E to 10 CFR Part 20.
    The NRC has chosen not to extend this new limit on generally 
licensed devices down to the 10 CFR 31.5(c)(13)(i) registration levels, 
as requested by the OAS in its rulemaking petition because it is 
neither necessary nor appropriate from a source aggregation and cost-
benefit basis. The NRC believes that the relatively low security risk 
posed by lower Category 4 and Category 5 sources does not justify the 
significant regulatory resources and impacts on licensees that would 
result from specifically licensing devices with lower Category 4 and 
Category 5 sources. Instead, the NRC has left the GL registration 
program as it currently exists for general licensees below the new GL 
limit because the rationale for instituting the GL registration program 
in the 1999 and 2000 rule amendments continues to remain valid today. 
The NRC successfully implemented the GL registration program with 80 to 
98 percent of general licensees responding annually with completed 
registration forms. This rate of registration can be attributed in part 
to general licensees' enhanced awareness of regulatory reporting, 
transfer, disposal, and recordkeeping requirements.
    Nevertheless, the NRC recognizes the desire on the part of the 
States supporting the OAS petition to exercise greater control over the 
actions of their licensees. Therefore, the NRC is proposing to revise 
the Compatibility Category of 10 CFR 31.5(a) from ``B'' to ``C'' and 
the Compatibility Category of 10 CFR 31.6 from ``B'' to ``C.'' The OAS 
stated that these actions were needed to establish a higher national 
standard of regulation for higher risk generally licensed devices, and 
to allow retention of a tool used by Agreement States to track the 
location and movement of device manufacturers and service providers 
within the State limits. Revising these compatibility categories would 
provide the Agreement States the flexibility to adopt additional 
requirements, based on their circumstances and needs. The NRC is also 
revising the Compatibility Category of 10 CFR 31.5(c)(13)(i) from ``B'' 
to ``C.'' Florida stated that this action was necessary to avoid having 
to relax its existing health, safety, and security controls to be 
compatible with less stringent national standards in NRC's regulations. 
Florida also noted that the registering of additional generally 
licensed devices in Florida does not have direct and significant effect 
on the transportation of the devices or on their movement into and out 
of Florida.

C. Specific Licensees and Generally Licensed Devices

    The Commission is considering an additional revision to 10 CFR 
31.5. This amendment would clarify the applicable requirements when a 
device that is authorized to be used under the general license in 10 
CFR 31.5 is instead held by a licensee under an SL. Currently, a 
specific licensee may obtain a device approved for use under 10 CFR 
31.5 as a specifically licensed device rather than use the authority of 
the GL. If a device is initially obtained as a generally licensed 
device, it can later be transferred for use under the SL in accordance 
with the procedures outlined in 10 CFR 31.5(c)(8)(iii). Some licensees 
have found it easier to comply with the regulations if all of their 
radioactive material is covered by the same requirements. Others have 
used these devices under their SL in order to minimize their fees. The 
proposed rule would add a new paragraph, 10 CFR 31.5(b)(3), to further 
clarify that when a device is held under an SL, all terms and 
conditions of the SL apply, and the requirements in 10 CFR 31.5 do not 
apply.
    The Commission is also considering and may include in the final 
rule an additional change concerning generally

[[Page 38378]]

licensed devices held by specific licensees. The proposal would 
prohibit specific licensees from possessing generally licensed devices 
under 10 CFR 31.5 at the same site. Any specific licensee possessing a 
device generally licensed under 10 CFR 31.5 at a site for which an SL 
is in place would be required to transfer the device to the authority 
of their SL. As noted, the possession and use of the device would then 
be subject to the terms and conditions of the user's SL. Any such 
device obtained by specific licensees in the future would be required 
to be obtained as a specifically licensed device. Under these 
requirements, all licensed material at a site where specifically 
licensed material is used would be governed by the same set of 
regulations.
    This option to require all such devices to be held under the SL 
would make the requirements for these devices uniform with the other 
material held under the SL. All licensed material at a site (where 
specifically licensed material is used) would be governed by the same 
set of regulations and accounted for uniformly. The Commission believes 
that this proposal would reduce confusion and improve compliance with 
the regulations because a licensee would have to follow only one set of 
requirements at each site. This proposal would also reduce the number 
of generally licensed devices that the NRC would need to track.
    If this approach is included in the final rule, it is anticipated 
that the restriction would be limited to devices used at sites covered 
by the SL. There may be specifically licensed entities, such as large 
corporations, that hold generally licensed devices at other sites where 
specifically licensed material is not used. Such operations may be 
quite independent of the specifically licensed activities. It would be 
too burdensome to apply the requirements connected with an SL to 
generally licensed devices at separate sites owned by the same licensed 
entity.

D. Specific Questions for Comment

    The NRC invites comment on its proposal to place a limit on the 
quantity of byproduct material allowed in generally licensed devices, 
specifically:
    (1) Whether the \1/10\ of IAEA Category 3 limit is the appropriate 
threshold level of byproduct material below which general licenses 
would still apply;
    (2) Whether there should be additional protection against 
aggregation of sources by either requiring that if the aggregated 
amount of byproduct material that a general licensee possesses in 
devices exceeds \1/10\ of IAEA Category 3, then the general licensee 
must obtain an SL, or more simply, by using the IAEA Category 4 
threshold level as the limit for the GL;
    (3) Whether an even lower threshold limit for requiring licensees 
to obtain a SL should be used, such as the registration levels in 10 
CFR 31.5(c)(13)(i). In providing support for this approach, the NRC is 
interested in whether there is specific information (i.e., lack of 
accountability due to generally licensed devices being lost and/or 
abandoned) that would indicate that the GL registration program as 
instituted in the 1999 and 2000 rulemakings (see Section II.A.4.2 of 
this document) is no longer working satisfactorily from the standpoint 
of protecting the public health and safety from routine use of these 
devices by general licensees; or
    (4) Whether the approach regarding Compatibility Categories laid 
out in Section II.B of this document, i.e., in which States have 
flexibility to adopt more rigorous requirements for general licensees, 
based on their circumstances and needs, can work satisfactorily. In 
particular, will there be any significant transboundary issues related 
to this approach or, will such an approach not have direct and 
significant effect on the transportation of the devices or on their 
movement in and out of States?
    Concerning the proposal discussed in Section C of this document 
which would prohibit specific licensees from using GL devices under 10 
CFR 31.5 and would require these devices to be possessed and used under 
an SL, the Commission requests comments to assist in its evaluation of 
the impacts of such a change on specific licensees and on how best to 
implement the change. Specific questions for comment:
    (A) How should this change be applied in the case of devices used 
by a specific licensee at different locations? Would there be 
difficulties in determining which devices used by a given entity must 
be under the specific license, if the applicability of 10 CFR 31.5 were 
to be determined by the location of use, as suggested?
    (B) How much time should be allowed for the specific licensees to 
transfer their currently held generally licensed GL devices to their 
SLs? Should devices currently held under the GL only be added to the SL 
only at the time of license renewal or amendment?
    (C) Should the details of the voluntary transfer process in 10 CFR 
31.5(c)(8)(iii) become mandatory and be maintained in the regulation to 
assist the process?
    (D) Would there be a significant impact from the applicability of 
reciprocity requirements in 10 CFR 150.20 for portable gauges currently 
licensed under 10 CFR 31.5 and equivalent Agreement State regulations 
that are used in more than one jurisdiction? How would this proposal 
affect servicers of devices currently operating under the reciprocity 
provision of 10 CFR 31.6 and equivalent provisions of Agreement States?
    (E) Would it be preferable to maintain the applicability of 10 CFR 
31.5, but to apply some or all of the terms and conditions of the SLs, 
e.g., by removing the exemptions in 10 CFR 31.5(c)(10) for those 
holding an SL?
    (F) How much impact would there be to 10 CFR 32.51 licensees and 
Agreement State equivalent licensees to ensure that they are 
transferring these devices to entities without an SL?
    (G) Should the sealed source and device registration certificates 
authorizing devices for use under 10 CFR 31.5 and equivalent Agreement 
State regulations be required to address transfers to both general and 
specific licensees?

E. Implementation of the Proposed Rule Amendments

    The amended regulations would require a specific license for each 
devices or source containing byproduct material meeting or exceeding 
\1/10\ of the IAEA Category 3 thresholds as listed in Appendix E to 10 
CFR Part 20. Additional information regarding implementation of these 
requirements will be provided as part of guidance for complying with 
these amended regulations. Examples of information that may be in 
included in guidance are the types of information needed in a license 
application; how general licensees would be notified that they need to 
obtain an SL (e.g., by the regulator or by the manufacturer); how 
general licensees and/or NRC would identify the quantity of byproduct 
material in devices; how decay of the source radioactivity levels 
within generally licensed devices would be identified and considered; 
and the relationship of the requirements to the sealed sources and 
device (SS&D) registry.
    The rule would become effective 60 days after the final rule is 
published in the Federal Register. Any general licensee that currently 
possesses generally licensed devices meeting or exceeding \1/10\ of the 
IAEA's Category 3 thresholds would be given an additional 90 days 
beyond the effective date of the final rule to submit an application 
for a specific license (i.e., 150 days after the final rule is 
published in the Federal Register).

[[Page 38379]]

III. Discussion of Proposed Amendments by Section

10 CFR 31.5(a) General Domestic Licenses for Byproduct Material

    The proposed rule would amend 10 CFR 31.5(a) to limit the quantity 
of byproduct material in generally licensed devices to below \1/10\ of 
the IAEA's Category 3 threshold, for the isotopes listed in Appendix E 
to 10 CFR Part 20. Licensees who possess devices containing byproduct 
material meeting or exceeding these thresholds would be required to 
become specifically licensed, and would become subject to all 
applicable regulations. Devices containing byproduct material below 
these thresholds would continue to be generally licensed.
    The values corresponding to Category 3 and \1/10\ of Category 3 (or 
1/100 of Category 2) in Appendix E to 10 CFR Part 20 for byproduct 
material radionuclides are provided here as information along with the 
notes to the table.

----------------------------------------------------------------------------------------------------------------
                                                                                      \1/10\          \1/10\
              Radioactive material                  Category 3      Category 3      Category 3      Category 3
                                                       (TBq)           (Ci)            (TBq)           (Ci)
----------------------------------------------------------------------------------------------------------------
Actinium-227....................................            0.02            0.54           0.002           0.054
Americium-241...................................            0.06            1.6            0.006           0.16
Americium-241/Be................................            0.06            1.6            0.006           0.16
Californium-252.................................            0.02            0.54           0.002           0.054
Cobalt-60.......................................            0.03            0.81           0.003           0.081
Curium-244......................................            0.05            1.4            0.005           0.14
Cesium-137......................................            0.1             2.7            0.01            0.27
Gadolinium-153..................................            1              27              0.1             2.7
Iridium-192.....................................            0.08            2.2            0.008           0.22
Plutonium-238...................................          N/A             N/A            N/A             N/A
Plutonium-239/Be................................          N/A             N/A            N/A             N/A
Polonium-210....................................            0.06            1.6            0.006           0.16
Promethium-147..................................           40            1100              4             110
Radium-226......................................            0.04            1.1            0.004           0.11
Selenium-75.....................................            0.2             5.4            0.02            0.54
Strontium-90....................................            1.0            27              0.1             2.7
Thorium-228.....................................          N/A             N/A            N/A             N/A
Thorium-229.....................................          N/A             N/A            N/A             N/A
Thulium-170.....................................           20             540              2              54
Ytterbium-169...................................            0.3             8.1            0.03            0.81
----------------------------------------------------------------------------------------------------------------
Note: N/A means ``not applicable'' because Plutonium-238 and Plutonium-239/Be are not byproduct material but are
  special nuclear material. Thorium-228 and Thorium-229 are source material.

10 CFR 31.5(b)(3)

    A clarification concerning the applicable requirements for devices 
authorized for use under 10 CFR 31.5 but held under specific license 
would be added.

IV. Criminal Penalties

    For the purpose of Section 223 of the Atomic Energy Act (AEA) of 
1954, as amended, the Commission is proposing to amend 10 CFR Part 31 
under one or more of Sections 161b, 161i, or 161o of the AEA. Willful 
violations of the rule would be subject to criminal enforcement.

V. Agreement State Compatibility

    Under the ``Policy Statement on Adequacy and Compatibility of 
Agreement State Programs'' approved by the Commission on June 30, 1997, 
and published in the Federal Register on September 3, 1997 (62 FR 
46517), the proposed rule would be a matter of compatibility between 
the NRC and the Agreement States, thereby providing consistency among 
the Agreement States and the NRC's requirements. The NRC staff analyzed 
the proposed rule in accordance with the procedure established in Part 
III, ``Categorization Process for NRC Program Elements,'' of Handbook 
5.9 to Management Directive 5.9, ``Adequacy and Compatibility of 
Agreement State Programs.''
    As a result of the amendments to 10 CFR 31.5(a) and new section 
(b)(3), these sections would now be designated as Compatibility 
Category C. Compatibility Category C are those program elements that do 
not meet the criteria of Category A or B, but the essential objectives 
of which an Agreement State should adopt to avoid conflict, 
duplication, gaps, or other conditions that would jeopardize an orderly 
pattern in the regulation of agreement material on a national basis. An 
Agreement State should adopt these essential objectives. After 
considering the issues associated with the compatibility requirements 
for 10 CFR 31.5(c)(13)(i), this section would now be designated as 
Compatibility Category C. After considering the issues associated with 
the compatibility requirements for 10 CFR 31.6, this section would now 
be designated as Compatibility Category C.
    For the reasons provided in Section B of this document, the NRC is 
proposing to designate 10 CFR 31.5(a), (b)(3), (c)(13)(i), and 31.6 as 
Compatibility Category C and, by so doing, Agreement States would have 
flexibility to adopt additional requirements, based on their 
circumstances and needs, if necessary. This would also allow Agreement 
States the flexibility to adopt additional requirements for tracking 
the movement of service providers and the location of generally 
licensed devices. Designating 10 CFR 31.5(a) and 31.6 as Compatibility 
Category C would address the issues and concerns raised by the OAS in 
their June 2005, petition for rulemaking. Designating 10 CFR 
31.5(c)(13)(i) as Compatibility Category C the NRC would address the 
issues and concerns raised by the State of Florida in their June 2005 
request as part of the petition. Considering these issues in this 
rulemaking action closes the entire petition.

VI. Plain Language

    The Presidential Memorandum ``Plain Language in Government 
Writing'' published June 10, 1998 (63 FR 31883), directed that the 
Government's documents be in clear and accessible language. The NRC 
requests comments on this proposed rule specifically with respect to 
the clarity and effectiveness of the language used. Comments should be 
sent to the address listed under the ADDRESSES heading.

VII. Voluntary Consensus Standards

    The National Technology Transfer Act of 1995 (Pub. L. 104-113) 
requires that Federal agencies use technical standards

[[Page 38380]]

that are developed or adopted by voluntary consensus standards bodies 
unless the use of such a standard is inconsistent with applicable law 
or otherwise impractical. In this proposed rule, the NRC would require 
licensees that possess generally licensed devices with any of the 
radioactive sources and thresholds specified in the proposed rule to 
submit an application for a specific license. This action does not 
constitute the establishment of a standard that contains generally 
applicable requirements.

VIII. Environmental Impact: Categorical Exclusion

    The NRC has determined that this proposed rule is the type of 
action described as a categorical exclusion in 10 CFR 51.22(c)(3)(iii). 
Therefore, neither an environmental impact statement nor an 
environmental assessment has been prepared for this proposed rule.

IX. Paperwork Reduction Act Statement

    This proposed rule contains new or amended information collection 
requirements that are subject to the Paperwork Reduction Act of 1995 
(44 U.S.C. 3501 et seq.). This rule has been submitted to the Office of 
Management and Budget (OMB) for review and approval of the information 
collection requirements.
    Type of submission, new or revision: Revision.
    The title of the information collection: 10 CFR Part 31, Limiting 
the Quantity of Byproduct Material in a Generally Licensed Device.
    How often the collection is required: Initially during license 
applications and at license renewals and amendments and other reporting 
for specific licenses.
    Who would be required or asked to report: Licensees in possession 
of devices containing quantities of byproduct material meeting or 
exceeding \1/10\ of the IAEA Code of Conduct's Category 3 thresholds.
    An estimate of the number of annual responses: 2,975 (1,575 
responses; 1,400 recordkeepers).
    The estimated number of annual respondents: 1,400 (280 NRC; 1,120 
Agreement State).
    An estimate of the total number of hours needed annually to 
complete the requirement or request: 31,114.
    Abstract: The NRC is proposing to amend its regulations to limit 
the amount of certain byproduct material in a generally licensed device 
to below \1/10\ of the IAEA Category 3 thresholds. The proposed 
amendment would require licensees possessing devices meeting or 
exceeding these thresholds to submit an application for a specific 
license. The NRC and/or the Agreement States would review such 
applications and issue licenses as appropriate.
    The NRC is seeking public comment on the potential impact of the 
information collections contained in this proposed rule and on the 
following issues:
    1. Is the proposed information collection necessary for the proper 
performance of the functions of the NRC, including whether the 
information would have practical utility?
    2. Is the estimate of burden accurate?
    3. Is there a way to enhance the quality, utility, and clarity of 
the information to be collected?
    4. How can the burden of the information collection be minimized, 
including the use of automated collection techniques?
    A copy of the OMB clearance package may be viewed free of charge at 
the NRC Public Document Room, One White Flint North, 11555 Rockville 
Pike, Room O-1 F21, Rockville, Maryland 20852. The OMB clearance 
package and rule are available at the NRC Worldwide Web site: http://www.nrc.gov/public-involve/doc-comment/omb/index.html for 60 days after 
the signature date of this notice.
    Send comments on any aspect of these proposed information 
collections, including suggestions for reducing the burden and on the 
above issues, by September 2, 2009 to the Records and FOIA/Privacy 
Services Branch (T-5 F52), U.S. Nuclear Regulatory Commission, 
Washington, DC 20555-0001, or by Internet electronic mail to 
[email protected] and to the Desk Officer, Christine Kymn, 
Office of Information and Regulatory Affairs, NEOB-10202 (3150-0016), 
Office of Management and Budget, Washington, DC 20503. Comments on the 
proposed information collections may also be submitted via Federal 
Rulemaking Web site http://www.regulations.gov, Docket ID NRC-2008-
0272. Comments received after this date will be considered if it is 
practical to do so, but assurance of consideration cannot be given to 
comments received after this date. You may also e-mail comments to 
[email protected] or comment by telephone at (202) 395-
4638.

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 draft regulatory analysis on this 
proposed regulation. The analysis examines the costs and benefits of 
the alternatives considered by the Commission.
    The Commission requests public comment on the draft regulatory 
analysis. Comments may be submitted to the NRC as indicated under the 
ADDRESSES heading. The analysis is available for inspection in the NRC 
Public Document Room, 11555 Rockville Pike, Rockville, MD 20852, or 
online at http://www.regulations.gov. Single copies of the draft 
regulatory analysis are available from Solomon Sahle, telephone (301) 
415-3781, e-mail: [email protected], of the Office of Federal and 
State Materials and Environmental Management Programs.

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 would not, if 
promulgated, have a significant economic impact on a substantial number 
of small entities. The proposed rule would affect about 280 NRC 
licensees and approximately an additional 1,120 Agreement State 
licensees possessing generally licensed devices with certain byproduct 
materials meeting or exceeding the \1/10\ of IAEA's Category 3 
thresholds. Affected licensees include licensees using fixed gauges, x-
ray fluorescence density/moisture/level interface gauges, fixed 
thickness gauges, and any other licensees possessing devices with 
sources meeting or exceeding these thresholds, some of which may 
qualify as small business entities as defined by 10 CFR 2.810. However, 
the proposed rule is not expected to have a significant economic impact 
on these licensees.
    Because of the widely differing conditions under which impacted 
licensees operate, the NRC is specifically requesting public comment 
from licensees concerning the impact of the proposed regulation. The 
NRC particularly desires comment from licensees who qualify as small 
businesses, specifically as to how the proposed regulation would affect 
them and how the regulation may be tiered or otherwise modified to 
impose less stringent requirements on small entities while still 
adequately protecting the public health and safety. Comments on how the 
regulation could be modified to take into account the differing needs 
of

[[Page 38381]]

small entities should specifically discuss:
    (1) The size of the business and how the proposed regulation would 
result in a significant economic burden upon it as compared to a larger 
organization in the same business community;
    (2) How the proposed regulation could be further modified to take 
into account the business's differing needs or capabilities;
    (3) The benefits that would accrue, or the detriments that would be 
avoided, if the proposed regulation was modified as suggested by the 
commenter;
    (4) How the proposed regulation, as modified, would more closely 
equalize the impact of NRC regulations as opposed to providing special 
advantages to any individuals or groups; and
    (5) How the proposed regulation, as modified, would still 
adequately protect the public health and safety.
    Comments should be submitted as indicated under the ADDRESSES 
heading.

XII. Backfit Analysis

    The NRC has determined that the backfit rule does not apply to this 
proposed rule because the amendments in this rule modify conditions of 
a general license for byproduct material, and do not involve any 
provisions that would impose backfits as defined in 10 CFR 50.109, 
70.76, 72.62, and 76.76. Therefore, a backfit analysis has not been 
prepared for this proposed rule.

List of Subjects in 10 CFR Part 31

    Byproduct material, Criminal penalties, Labeling, Nuclear 
materials, Packaging and containers, Radiation protection, Reporting 
and recordkeeping requirements, Scientific equipment.

    For the reasons set out in the notice and under the authority of 
the Atomic Energy Act of 1954, as amended; the Energy Reorganization 
Act of 1974, as amended; and 5 U.S.C. 553; the NRC is proposing to 
adopt the following amendments to 10 CFR Part 31.

PART 31--GENERAL DOMESTIC LICENSES FOR BYPRODUCT MATERIAL

    1. The authority citation for part 31 continues to read as follows:

    Authority:  Secs. 81, 161, 183, 68 Stat. 935, 948, 954, as 
amended (42 U.S.C. 2111, 2201, 2233); secs. 201, as amended, 202, 88 
Stat. 1242, as amended, 1244 (42 U.S.C. 5841, 5842); sec. 1704, 112 
Stat. 2750 (44 U.S.C. 3504 note); sec. 651(e), Public Law 109-58, 
119 Stat. 806-810 (42 U.S.C. 2014, 2021, 2021b, 2111).

    2. In Sec.  31.5, paragraph (a) is revised and paragraph (b)(3) is 
added to read as follows:


Sec.  31.5   Certain detecting, measuring, gauging, or controlling 
devices and certain devices for producing light or an ionized 
atmosphere.

    (a) A general license is hereby issued to commercial and industrial 
firms and research, educational and medical institutions, individuals 
in the conduct of their business, and Federal, State or local 
government agencies to acquire, receive, possess, use or transfer, in 
accordance with the provisions of paragraphs (b), (c) and (d) of this 
section, byproduct material contained in devices designed and 
manufactured for the purpose of detecting, measuring, gauging or 
controlling thickness, density, level, interface location, radiation, 
leakage, or qualitative or quantitative chemical composition, or for 
producing light or an ionized atmosphere, provided that each device 
contains byproduct material in quantities less than 1/100th of the 
thresholds listed in Appendix E of 10 CFR Part 20 for Category 2.
    (b) * * *
    (3) For devices meeting the criteria of this general license, but 
instead held under the authority of a specific license, all of the 
terms and conditions of the specific license apply in lieu of the 
provisions in this general license.
* * * * *

    Dated at Rockville, Maryland, this 28th day of July 2009.

    For the Nuclear Regulatory Commission.
Andrew L. Bates,
Acting Secretary for the Commission.
[FR Doc. E9-18438 Filed 7-31-09; 8:45 am]
BILLING CODE 7590-01-P