[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]]
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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.
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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