Request for Comments on the Draft Policy Statement on the Protection of Cesium-137 Chloride Sources and Notice of Public Meeting, 37483-37488 [2010-15734]
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Federal Register / Vol. 75, No. 124 / Tuesday, June 29, 2010 / Notices
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application by the individual
challenging the record to the agency
(i.e., law enforcement agency) that
contributed the questioned information,
or direct challenge as to the accuracy or
completeness of any entry on the
criminal history record to the Assistant
Director, Federal Bureau of
Investigation, Identification Division,
Washington, DC 20537–9700 (as set
forth in 28 CFR 16.30 through 16.34). In
the latter case, the FBI forwards the
challenge to the agency that submitted
the data and requests that agency to
verify or correct the challenged entry.
Upon receipt of an official
communication directly from the agency
that contributed the original
information, the FBI Identification
Division makes any changes necessary
in accordance with the information
supplied by that agency. The licensee
must provide at least ten (10) days for
an individual to initiate an action
challenging the results of an FBI
criminal history records check after the
record is made available for his/her
review. The licensee may make a final
SGI access determination based upon
the criminal history record only upon
receipt of the FBI’s ultimate
confirmation or correction of the record.
Upon a final adverse determination on
access to SGI, the licensee shall provide
the individual its documented basis for
denial. Access to SGI shall not be
granted to an individual during the
review process.
Protection of Information
1. Each licensee who obtains a
criminal history record on an individual
pursuant to this Order shall establish
and maintain a system of files and
procedures for protecting the record and
the personal information from
unauthorized disclosure.
2. The licensee may not disclose the
record or personal information collected
and maintained to persons other than
the subject individual, his/her
representative, or to those who have a
need to access the information in
performing assigned duties in the
process of determining access to
Safeguards Information. No individual
authorized to have access to the
information may re-disseminate the
information to any other individual who
does not have a need-to-know.
3. The personal information obtained
on an individual from a criminal history
record check may be transferred to
another licensee if the licensee holding
the criminal history record check
receives the individual’s written request
to re-disseminate the information
contained in his/her file, and the
current licensee verifies information
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such as the individual’s name, date of
birth, social security number, sex, and
other applicable physical characteristics
for identification purposes.
4. The licensee shall make criminal
history records, obtained under this
section, available for examination by an
authorized representative of the NRC to
determine compliance with the
regulations and laws.
5. The licensee shall retain all
fingerprint and criminal history records
received from the FBI, or a copy if the
individual’s file has been transferred,
for three (3) years after termination of
employment or determination of access
to SGI (whether access was approved or
denied). After the required three (3) year
period, these documents shall be
destroyed by a method that will prevent
reconstruction of the information in
whole or in part.
[FR Doc. 2010–15730 Filed 6–28–10; 8:45 am]
BILLING CODE 7590–01–P
NUCLEAR REGULATORY
COMMISSION
[NRC–2010–0209]
Request for Comments on the Draft
Policy Statement on the Protection of
Cesium-137 Chloride Sources and
Notice of Public Meeting
AGENCY: Nuclear Regulatory
Commission (NRC).
ACTION: Request for public comment and
notice of public meeting.
SUMMARY: The U.S. Nuclear Regulatory
Commission (NRC) is considering
adopting a statement of policy on the
protection of cesium-137 chloride (CsCl)
sources. This statement would provide
the Commission’s policy regarding
secure uses of these sources at the
present and express the Commission’s
potential actions in the event that
changes in the threat environment
necessitate these actions. The purpose
of this policy statement is to delineate
the Commission’s expectations for
security and safety of these sources.
This draft policy statement is being
issued for public comment.
Additionally, the NRC is conducting a
public meeting to solicit public input on
major issues associated with the draft
policy statement regarding the current
use of certain forms of Cs-137 sources
used by NRC- and Agreement Statelicensees. Furthermore, the NRC is
requesting names of individuals to
participate at the public meeting in
separate roundtable panel discussions of
the issues identified in Sections III and
IV of this notice.
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37483
DATES: 1. Comments on the draft policy
statement should be submitted by
December 17, 2010. Comments received
after this date will be considered if it is
practical to do so, but the NRC is able
to assure consideration only for
comments received on or before this
date.
2. Nominations for participation in
the roundtable discussions of the public
meeting should be submitted by October
8, 2010. For expeditious handling of the
nominations, the NRC established a
dedicated e-mail address. The
nominations should be sent to the
following NRC e-mail address:
CesiumDraftPolicy@nrc.gov.
3. Other participants, who wish to
attend the public meeting, could also
pre-register at the dedicated e-mail
address: CesiumDraftPolicy@nrc.gov.
The Commission will appreciate preregistration in order to properly plan for
the conference facilities. However, preregistration is not required and preregistration is open until the opening
day of the public meeting.
Public Meeting Dates: The NRC will
take public comments on the issues
raised in this document at a public
meeting on November 16–17, 2010. The
location of the public meeting has not
been finalized. However, the location is
planned to be near the NRC
Headquarters in the Rockville,
Maryland, area. The location and the
agenda of the public meeting will be
posted at the dedicated Web site
https://www.nrc.gov/materials/miau/
licensing.html#cc, as soon as this
information is finalized. Please refer to
the SUPPLEMENTARY INFORMATION section
for additional information.
ADDRESSES: Please include Docket ID
NRC–2010–0209 in the subject line of
your comments. For instructions on
submitting comments and accessing
documents related to this action, see
Section I, ‘‘Submitting Comments and
Accessing Information’’ in the
SUPPLEMENTARY INFORMATION section of
this document. You may submit
comments by any one of the following
methods.
Federal Rulemaking Web Site: Go to
https://www.regulations.gov and search
for documents filed under Docket ID
NRC–2010–0209. Address questions
about NRC dockets to Carol Gallagher,
telephone (301) 492–3668; e-mail
Carol.Gallagher@nrc.gov.
Mail comments to: Cindy Bladey,
Chief, Rules, Announcements and
Directives Branch, Office of
Administration, MS: TWB–5 B1M, U.S.
Nuclear Regulatory Commission,
Washington, DC 20555–0001.
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FOR FURTHER INFORMATION CONTACT: Dr.
John P. Jankovich, Office of Federal and
State Materials and Environmental
Management Programs, telephone (301)
415–7904, e-mail
john.jankovich@nrc.gov, or Dr. Cynthia
G. Jones, Office of Nuclear Security and
Incident Response, telephone (301) 415–
0298, e-mail cynthia.jones@nrc.gov.
SUPPLEMENTARY INFORMATION:
I. Submitting Comments and Accessing
Information
Comments submitted in writing or in
electronic form will be posted on the
NRC Web site and on the Federal
rulemaking Web site https://
www.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.
You can access publicly available
documents related to this document,
including the following documents,
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, Room O–
1F21, One White Flint North, 11555
Rockville Pike, Rockville, Maryland.
NRC’s Agencywide Documents 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 https://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
or 301–415–4737, or by e-mail to
PDR.Resource@nrc.gov.
Federal Rulemaking Web Site: Public
comments and supporting materials
related to this document can be found
at https://www.regulations.gov by
searching on Docket ID NRC–2010–
0209.
II. Background
Certain radioactive sources, including
CsCl sources, have been identified by
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the International Atomic Energy Agency
(IAEA) Code of Conduct on the Safety
and Security of Radioactive Sources
(Code of Conduct) (see https://wwwpub.iaea.org/MTCD/publications/PDF/
Code-2004_web.pdf) as sources that may
pose a significant risk to individuals,
society, and the environment if
improperly handled or used in a
malicious act. Consequently, the NRC
considers it prudent to express its views
on the safe and secure use of these
sources. CsCl sealed sources are used in
many applications, most commonly in
irradiators, calibrators, and in devices
for biological and medical research. To
develop its draft policy statement, the
NRC initiated and completed a number
of initiatives. A significant element of
these initiatives was an Issue Paper
which was published in the Federal
Register on July 31, 2008 (73 FR 44780),
and discussed with stakeholders in a
public workshop held on September 29–
30, 2008. The NRC also received
numerous written comments on the
issues. The oral and written comments
as well as the transcript of the
workshop, along with other relevant
information, are accessible at https://
www.nrc.gov/materials/miau/
licensing.html#cesium.
The NRC is seeking public input on
the major issues associated with its
policy involving CsCl to reduce the risk
to individuals, society, and the
environment. As a first step, the NRC
has prepared a draft policy statement,
contained in Section III of this
document, which describes issues
related to safety and security associated
with IAEA Category 1 and 2 CsCl
sources.1 The intent of this document is
to foster discussion about these issues
and to solicit comments on the draft
policy statement. The NRC will also use
a public Web site, https://www.nrc.gov/
materials/miau/licensing.html#cc to
make documents, relevant to the draft
policy statement and to the public
meeting, accessible. This public Web
site will be continually updated as new
information becomes available. The
exact location and the agenda of the
public meeting will also be posted at
this site as soon as they become
finalized.
1 An IAEA Category 1 cesium-137 source contains
a minimum of 3000 Ci (100 TBq) and a Category
2 source contains a minimum of 30 Ci (1 TBq). See
https://www-pub.iaea.org/MTCD/publications/PDF/
Code-2004_web.pdf.
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III. Draft Policy Statement of the U.S.
Nuclear Regulatory Commission on the
Protection of Cesium-137 Chloride
Sources
The NRC’s Role in Ensuring Security for
Radioactive Materials
The NRC has the responsibility to
license and regulate the civilian use of
radioactive materials for commercial,
industrial, academic, and medical
purposes in a manner that protects
public health and safety and promotes
the common defense and security. The
NRC and its predecessor, the Atomic
Energy Commission, have regulated the
use of radioactive materials since 1946.
The use of radioactive materials is
regulated by the NRC and 37 states,
known as Agreement States. Agreement
States enter into agreements with the
NRC under Section 274 of the Atomic
Energy Act to license and regulate the
use of byproduct material within their
borders.
The security and control of radiation
sources is an essential part of the NRC’s
mission. The NRC’s efforts in this regard
continue to be effective, and there have
been no security incidents involving
risk-significant radiation sources. After
September 11, 2001, the NRC imposed
additional security requirements. In
addition, the National Nuclear Security
Administration (NNSA) has initiated a
program to enhance security voluntarily
beyond these requirements. One type of
radioactive source, cesium-137 chloride
(CsCl), has been the focus of increased
attention in the U.S. because these
sources are extensively used in a wide
range of applications in medicine,
industry, and research and, while
unlikely, due to the physical and
chemical characteristics of CsCl, these
sources could be used by terrorists in a
radiological dispersal device or ‘‘dirty
bomb.’’
The NRC supports and implements
the recommendations of the
international community regarding the
safe use and protection of radioactive
materials. In 2004, the International
Atomic Energy Agency (IAEA) issued
the Code of Conduct for the Safety and
Security of Radioactive Sources (the
Code), which prescribes a legislative
framework, regulatory programs, and
import/export provisions to achieve and
maintain a high level of safety and
security of radioactive sources. The U.S.
Government is committed to the
implementation of the Code. The Code
applies to all radioactive sources that
could pose a significant risk to
individuals, society, and the
environment. The Code establishes five
categories of radioactive sources based
on their potential to cause severe
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deterministic health effects if not
managed in a safe and secure manner.
Consistent with the Code, the NRC and
the Agreement States have established
national requirements for the enhanced
security for Category 1 and 2 quantities
of radioactive material, which, if
misused, could pose a significant risk to
individuals, society, and the
environment.
To maintain security of sources, the
Energy Policy Act of 2005 (EPAct)
directed the NRC to establish and lead
the Radiation Source Protection and
Security Task Force (Task Force) to
evaluate and provide recommendations
to the President and Congress
periodically relating to the security of
radiation sources in the U.S. from
potential terrorist threats, including acts
of sabotage, theft, or use of a radiation
source in a radiological dispersal
device. The EPAct named 12 Federal
agencies to the Task Force. In addition
to the named agencies, the NRC invited
the U.S. Department of Health and
Human Services and the White House
Office of Science and Technology Policy
to participate. To accomplish the
mission in view of the regulatory
responsibilities divided in the U.S.
between the NRC and the Agreement
States, the Task Force also invited a
representative of the Organization of
Agreement States and the Conference of
Radiation Control Program Directors to
participate as a non-voting member.
NRC has coordinated with these
partners consistent with its regulatory
role, to enhance the security of sources,
including CsCl. The Task Force issued
its first report in 2006,2 and is
scheduled to issue another report in
2010. The NRC’s security requirements
for radioactive sources are aligned with
the recommendations of the first Task
Force report.
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Statement of Policy
It is the policy of the Commission that
its mission of ensuring adequate
protection of public health and safety,
common defense and security, and the
environment while enabling the use of
radioactive materials for beneficial
civilian purposes is best accomplished
with respect to CsCl by implementing or
promoting the following principles:
• The safety and security of risk
significant sources is an essential part of
the NRC’s mission;
• Licensees have the primary
responsibility to securely manage and to
2 Report to the President and the U.S. Congress
Under Public Law 109–58, The Energy Policy Act
of 2005, The Radiation Source Protection and
Security Task Force Report, NRC Reference No.
ML062190349.
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protect sources in their possession from
misuse, theft, and radiological sabotage;
• Adequate protection of public
health and safety is maintained if CsCl
sources are managed in accordance with
the security requirements of the NRC
and the Agreement States. These
requirements are based on vulnerability
assessments of the various sources and
follow the principles of the Code of
Conduct on the Safety and Security of
Radioactive Sources of the International
Atomic Energy Agency;
• While these sources are adequately
protected under the current NRC
requirements, design improvements
could be made that further mitigate or
minimize the radiological
consequences;
• The development and use of
alternative forms of cesium-137, while
not required for adequate protection, is
prudent and the NRC intends to monitor
these developments closely. In addition,
the NRC recognizes that measures to
verify effectiveness of the alternatives
for solubility and dispersibility must be
established to support future decisionmaking on this matter;
• CsCl enables three specific classes
of applications that benefit society: (a)
Blood irradiation, (b) bio-medical and
industrial research, and (c) calibration
of instrumentation and dosimetry;
• The NRC recognizes that currently
there is no disposal capability for such
commercial sources. The NRC considers
it imperative to develop a pathway for
the long term storage and disposal of
these sources whether or not there are
alternatives developed; and
• The NRC monitors the threat
environment and maintains awareness
of international and domestic security
efforts. In the event that changes in the
threat environment necessitate
regulatory action, the NRC is ready to
issue additional security requirements
to apply appropriate limitations for the
use of CsCl in its current form.
Background
Security and Control of Radioactive
Sources
Strong measures and regulatory
requirements are currently in place for
ensuring security and control of
radioactive sources. After the terrorist
events of September 11, 2001, the NRC
and Agreement States issued security
requirements mandating that licensees
who possess IAEA Category 1 or 2
quantities of radioactive materials
implement increased security and
control measures to reduce the risk of
malevolent use and intentional
unauthorized access to radioactive
material. The additional requirements
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37485
enhanced and supplemented existing
regulations in 10 CFR 20.1801, ‘‘Security
of Stored Material,’’ and 10 CFR
20.1802, ‘‘Control of Material Not in
Storage,’’ which are primarily intended
to prevent or mitigate unintended
exposure to radiation.
Current security requirements include
access controls and background checks
for personnel; monitoring, detecting and
responding to unauthorized access;
delay; advance coordination with local
law enforcement; and the tracking of
transfers and shipments. The security
requirements require licensees to
establish and implement
trustworthiness and reliability standards
to determine who will have unescorted
access to the radioactive material. An
individual’s trustworthiness and
reliability is based upon a background
investigation. The NRC and Agreement
States have jointly developed materials
protection and security regulatory
requirements that reflect the experience
gained through implementation of
existing requirements.
In addition, the NRC has
implemented new regulatory
requirements for import/export
licensing and for reporting to the
National Source Tracking System
(NSTS) which increase accountability of
Category 1 and 2 radioactive material
transactions and help to ensure that
such transactions are only made by
authorized entities. The NRC developed
and maintains the NSTS, which
provides information on sources from
the time of manufacture through
transportation and use to end-of-life
disposition. The NSTS and other
systems under development, such as
Web-Based-Licensing and License
Verification System, are key
components of a comprehensive
program for the security and control of
radioactive materials. When complete,
these systems will include information
on all NRC, Agreement State, and
import/export licensees and high risk
radioactive sources.
The measures described above are in
place to ensure the security of all
Category 1 and 2 radioactive sources,
including CsCl sources. These measures
have reduced the vulnerability of CsCl
sources. In addition, the NRC and
Agreement States are supporting the
U.S. Department of Energy’s (DOE’s)
NNSA voluntary program to retrofit
existing CsCl irradiators with physical
security enhancements and to
incorporate these improvements into the
designs of newly manufactured units.
These modifications extend beyond
current regulatory requirements. These
efforts are often complemented by
expert security guidance to licensees
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(assist visits) and table-top exercises
that allow participants to share best
practices.
The NRC and Agreement States also
support the Federal Bureau of
Investigation’s ongoing Weapons of
Mass Destruction (WMD)
countermeasure effort to reach out to
certain communities of licensees
(including the CsCl irradiator licensee
community). A critical aspect of this
WMD countermeasure effort is
information sharing through visits to
licensees. These visits encourage
communication and allow regulators,
law enforcement, and licensees to gain
an understanding of a licensee’s security
arrangements and how and when law
enforcement would be engaged if there
were a threat or an event at a licensee’s
site.
The NRC supports the security
initiatives of international organizations
(e.g., IAEA), and other countries, as well
as the initiatives of Federal agencies
aimed to further increase the protection
of high risk sources overseas (e.g.,
NNSA’s Global Threat Reduction
Initiative). The NRC participates in the
development of such protective
measures in various international
forums and will consider their
applicability for use within the U.S. if
the threat environment changes,
warranting additional protective
measures.
Uses of CsCl Sources
CsCl sources comprise approximately
3% of the IAEA Category 1 and 2
quantity sources in the U.S. Many in the
medical and scientific communities
indicate that these CsCl sources are
important due to their application in
blood irradiation, bio-medical and
industrial research, and calibration of
instrumentation and dosimetry,
especially for critical reactor and first
responder equipment. CsCl is used for
these applications because of the
properties of the nuclide cesium-137
(Cs-137), including its desirable single
energy spectrum (662 keV), long halflife, low cost, and moderate shielding
requirements relative to other nuclides.
The CsCl used in these applications is
in a compressed powder form that is
doubly-encapsulated in two stainless
steel capsules to ensure safety and
security in normal use. This physical
form is used because of its high specific
activity (gamma emission per unit
volume) and manufacturability.
However, the powder is highly soluble
and dispersible, which presents security
concerns.
Blood irradiation is medically
essential to prevent transfusionassociated Graft-Versus-Host disease,
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and some hospitals use only irradiated
blood. CsCl blood irradiators are used in
over 90% of all blood irradiation
because they are the most reliable and
efficient blood irradiation devices
currently available.
In biomedical research, CsCl
irradiation has been used for over 40
years in fields such as immunology,
stem cell research, cancer research, invivo immunology, systemic drug
research, chromosome aberrations, DNA
damage/repair, human genome, and
genetic factors. For most research there
are no alternatives to Cs-137 irradiation
because of the unique properties of Cs137 radiation, such as high dose rates
with uniform fields of linear energy
transfer. No alternative technologies that
can effectively replace CsCl sources for
biomedical research have yet been
developed.
The U.S. and international systems of
radiation measurements are based on
the energy spectrum of Cs-137. All
American National Standards Institute
standards and their associated test-andevaluation protocols for radiation
detection, instrumentation, and
personal dosimetry rely on the use of
Cs-137. In addition, all DHS-related
standards for calibration of first
responder and emergency response
equipment, such as personnel selfreading dosimeters, portal monitors, and
portable survey instruments, also
require the use of Cs-137 for calibration
purposes. Cs-137 was selected by the
U.S. and the international community as
the basis of calibration because of the
optimal single energy spectrum of this
nuclide and its long half-life. The
National Institute of Standards and
Technology (NIST) maintains the
national measurement standards and
calibrates the instruments for secondary
laboratories. These instruments are sent
to secondary and tertiary laboratories
that, in turn, calibrate the instruments
for end users. This network of facilities
ensures that every radiation detection
instrument that is used in the country
measures correctly and is traceable to
NIST.
Ensuring Secure Disposal for Disused
CsCl Sources
The disposal of CsCl radioactive
sources, which are currently in use, is
a challenge because of the high cost of
disposal and the lack of commercial
disposal facilities. The vast majority of
the CsCl sources in use today are
classified as Greater-Than-Class C lowlevel radioactive waste. Today, used and
unwanted CsCl sources are stored safely
and securely at the users’ sites under the
applicable NRC and Agreement State
control and security requirements until
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commercial options become available.
To maintain source safety and security,
the sites are routinely inspected in
accordance with established NRC and
Agreement State inspection procedures.
The Commission considers it imperative
to develop a pathway for the long term
storage and disposal of these sources
because long term storage at licensee
facilities increases the potential for
safety and security issues. To resolve
these issues, the NRC will continue to
participate with its Federal and State
partners and representatives of the
private sector in initiatives to explore
medium- and long term-solutions to
address the need for disposal and
disposition of CsCl sources.
The Low-Level Radioactive Waste
Policy Amendments Act of 1985
assigned responsibility for providing
disposal of this type of waste to DOE.
However, pending the availability of a
disposal capability, DOE is not
responsible for accepting disused
sources for storage, transportation or
other activities related to disposal
except under special circumstances.2 At
the present time, no final decision has
been made to proceed with approval,
funding, and operation of a disposal
facility. The Commission will actively
support DOE in all phases of the process
to establish a storage facility for
permanent, safe and secure storage of
used and unwanted sources.
The NRC’s Perspective on Further
Security Enhancements
The NRC believes that the current
enhanced regulatory framework for
security of radioactive sources has been
very effective in enhancing and
ensuring the security and control of
risk-significant sources used in medical,
industrial, and research activities in the
U.S. The NRC encourages stakeholders
to take an active role in source security
and continue their efforts in
maintaining the current security
environment. As is necessary and
practical, and in response to any change
in the threat environment, the NRC will
work with other Federal agencies to
further enhance the secure use of Cs-137
sources. The NRC recognizes that it is
prudent to maintain awareness of the
status of research to identify alternative
forms of CsCl. NRC will remain
cognizant of these issues and
appropriately consider whether there
are safety and security benefits to
further risk reduction. As part of NRC’s
2 Under specified circumstances, and pursuant to
other authority and responsibility under the Atomic
Energy Act of 1954, DOE may recover excess or
unwanted sealed sources (including CsCl sources)
for reuse, storage or disposal that present threats to
public health, safety or national security.
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responsibility to ensure the security of
these sources, the NRC, in coordination
with its Federal partners, continuously
monitors the national threat
environment and is prepared to take
further regulatory actions should this
environment change. Just as it did
following the events following
September 11, 2001, the NRC is
prepared to take immediate action such
as issuance of additional security
requirements with orders or rulemaking
to address such security-related issues,
if necessary.
The NRC solicits stakeholder input
into major issues associated with the
use of CsCl. The Public Workshop on
the Security and Continued Use of
Cesium-137 Chloride Sources that the
NRC held in September 2008, is an
example of soliciting such input. The
workshop was attended by a large
number of stakeholders and, in addition
to the oral presentations and comments,
the NRC received a significant number
of written submissions. The workshop
provided valuable information for the
formulation of this Policy Statement
regarding the use of CsCl sources,
security issues, and the diversity of
impacts that licensees could experience
as a result of potential further regulatory
requirements.
While the current security
requirements are adequate, the NRC
recognizes that if the use of CsCl in its
current form is to continue, the NRC
encourages the source and device
manufacturers to implement design
improvements that further mitigate or
minimize the radiological consequences
of misuse or malevolent acts involving
these sources given that such events,
while unlikely, cannot be dismissed.
Similarly, the NRC supports efforts to
develop alternate forms of Cs-137 that
would further reduce the risk of
malevolent use associated with CsCl.
The National Research Council of the
National Academies (NA) issued a
report 3 that supported these efforts,
recommended that the NRC consider the
potential economic and social
disruption that changes to the CsCl
requirements could cause, and
supported a research and development
program for alternative ‘‘matrices’’ for
high-activity Cs-137 sources, which
would provide lowered security
hazards.
The NRC recognizes that objective
measures of ‘‘solubility’’ and
‘‘dispersibility’’ need to be defined
before alternate forms of Cs-137 that are
3 National Research Council of the National
Academies, ‘‘Radiation Source Use and
Replacement,’’ The National Academies Press,
Washington, DC, https://www.nap.org.
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19:55 Jun 28, 2010
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less-soluble and less-dispersible than
the compressed powder form can be
developed. The Commission has already
directed the NRC staff to work with
Federal agencies to define these
measures which must be readily
expressible in physical and chemical
terms and be demonstrated through
well-defined test protocols. In addition,
the criteria for the solubility and the
dispersibility measures must be
established at levels that ensure
enhancement of security and reduction
of risks of malevolent use.
Consequently, the criteria must be
developed and accepted by both the
cognizant technical communities and
the communities responsible for the
Nation’s security.
While it is outside the scope of NRC’s
mission to conduct developmental
research, the Commission encourages
stakeholder research to develop
alternative chemical forms for large
activity Cs-137 sources. One of the
recommendations made by the NA was
to investigate the development of
alternate chemical forms of Cs-137. The
NRC believes that such research should
engage cognizant Federal agencies and
should consider the practicality of
producing an end product that would
maintain the security as well as the
societal benefits of the current
applications of CsCl sources. The NRC
considers that pursuit of alternate forms
of cesium would provide benefits in the
longer term, because the technology of
manufacturing other forms of cesium is
not yet available. Given the state of the
current technology, NRC believes that,
for the short term, it is more feasible to
focus current security efforts on
strengthening existing security of
sources as necessary through
cooperative efforts and voluntary
initiatives of industries that currently
manufacture and use irradiators with
CsCl sources. While current NRC
security requirements ensure the safety
and security of these sources, it has
been shown through the voluntary
NNSA security initiative program that
further security enhancements and
future design improvements further
minimize the potential misuse or
malevolent acts involving these sources.
Summary
The NRC is continually working with
its domestic and international partners
to assess, integrate, and improve its
security programs, and to make risksignificant radiation sources more
secure and less vulnerable to terrorists.
The NRC has the responsibility to
ensure the safe and secure use and
control of radioactive sources, including
CsCl sources. The NRC has met this
PO 00000
Frm 00113
Fmt 4703
Sfmt 4703
37487
responsibility through imposition of
additional security requirements. The
NRC has articulated in the past that the
use of alternative forms of Cs-137 is
desirable. The NRC’s actions to date
have resulted in strong security
measures being established, and the
NRC recognizes that near term
replacement of devices or CsCl sources
in existing blood, research, and
calibration irradiators is not practicable
or necessary due to implementation of
the additional requirements and
considering a lack of a disposal
capacity. A clear strategy for the end-oflife management of these sources, which
is the responsibility of the DOE, is not
mature and likely will not be for some
time. Many medical, research, and
emergency response stakeholders have
indicated that short term replacement
would be detrimental. Therefore, the
NRC continues to believe that the
security of these facilities should be
maintained and enhanced as practical
through the implementation of the
regulatory requirements and through
voluntary actions such as the physical
security enhancements of existing
devices and future designs against
intrusion. The NRC supports efforts to
develop alternate forms of Cs-137 that
would reduce the security risks and will
monitor these developments closely.
The NRC will continue to work with its
federal partners to ensure the safety and
security of CsCl sources. In the event
that changes in the threat environment
necessitate regulatory action, the NRC is
ready to issue additional security
requirements to apply appropriate
limitations for the use of CsCl in its
current forms or for its replacement
with suitable alternatives.
IV. Plans for a Public Meeting
The NRC is holding a facilitated
public meeting on November 16–17,
2010, on the draft policy statement and
the following issues:
• The NRC’s role in ensuring security
for radioactive materials.
• Statement of Policy.
• Security and control of radioactive
sources.
• Uses of CsCl sources.
• Ensuring secure disposal for
disused CsCl sources.
• NRC’s perspective on further
security enhancements.
During the public meeting, NRC will
conduct roundtable panel discussion,
with opportunity for audience
participation, for each issue contained
in Sections III and IV of this document.
NRC is seeking the names of individuals
interested in participating on these
panels. Nominations by interested
individuals or organizations should
E:\FR\FM\29JNN1.SGM
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37488
Federal Register / Vol. 75, No. 124 / Tuesday, June 29, 2010 / Notices
include the name of the proposed panel
member, the issues they are interested
in discussing, viewpoint(s) on the
issue(s), and affiliation (if any).
Roundtable panel participants will be
selected with the goal of providing
balanced viewpoints on each of the
various issues. Please see the DATES
section to submit nominations by
October 8, 2010.
We encourage previous participants
who attended, either as panel members
or attendees, the prior public workshop,
held on September 29–30, 2008, to also
participate in this meeting. Information
on the previous public meeting is
accessible at https://www.nrc.gov/
materials/miau/licensing.html#cesium.
Based on the comments received in
both written and electronic form, and at
the public meeting, the Commission
will then be in a better position to
proceed with the issuance of a final
Policy Statement. The final Policy
Statement, when issued by the
Commission, will be published in the
Federal Register.
Small Business Administration, 409 3rd
Street, SW., Suite 6050, Washington, DC
20416.
SUPPLEMENTARY INFORMATION: The notice
of the President’s major disaster
declaration for Private Non-Profit
organizations in the Commonwealth of
Kentucky, dated 05/11/2010, is hereby
amended to include the following areas
as adversely affected by the disaster.
Primary Counties: Ballard, Carlisle,
Clark, Hickman.
All other information in the original
declaration remains unchanged.
(Catalog of Federal Domestic Assistance
Numbers 59002 and 59008)
added, deleted or postponed, please
contact:
The Office of the Secretary at (202)
551–5400.
Dated: June 24, 2010.
Elizabeth M. Murphy,
Secretary.
[FR Doc. 2010–15821 Filed 6–25–10; 11:15 am]
BILLING CODE 8011–01–P
SECURITIES AND EXCHANGE
COMMISSION
[Release No. 34–62359; File No. SR–FINRA–
2009–054]
Sunshine Act; Notice of Meeting
Dated at Rockville, Maryland, this 22 day
of June 2010.
For the Nuclear Regulatory Commission.
Cynthia Carpenter,
Deputy Director, Office of Federal and State
Materials and Environmental Management
Programs.
[FR Doc. 2010–15734 Filed 6–28–10; 8:45 am]
BILLING CODE 7590–01–P
SMALL BUSINESS ADMINISTRATION
[Disaster Declaration #12170 and #12171]
Kentucky Disaster Number KY–00033
Small Business Administration.
Amendment 5.
AGENCY:
emcdonald on DSK2BSOYB1PROD with NOTICES4
ACTION:
SUMMARY: This is an amendment of the
Presidential declaration of a major
disaster for Public Assistance Only for
the Commonwealth of Kentucky
(FEMA–1912–DR), dated 05/11/2010.
Incident: Severe Storms, Flooding,
Mudslides, and Tornadoes.
Incident Period: 05/01/2010 through
06/01/2010.
DATES: Effective Date: 06/16/2010.
Physical Loan Application Deadline
Date: 07/12/2010.
Economic Injury (EIDL) Loan
Application Deadline Date: 02/11/2011.
ADDRESSES: Submit completed loan
applications to: Small Business
Administration, Processing and
Disbursement Center, 14925 Kingsport
Road, Fort Worth, TX 76155.
FOR FURTHER INFORMATION CONTACT: A.
Escobar, Office of Disaster Assistance,
VerDate Mar<15>2010
19:55 Jun 28, 2010
Jkt 220001
SECURITIES AND EXCHANGE
COMMISSION
Self-Regulatory Organizations;
Financial Industry Regulatory
Authority, Inc.; Order Approving a
Proposed Rule Change, as Modified by
Amendment No. 1, To Establish in the
Market for OTC Equity Securities
Certain Regulatory Protections Derived
From Certain Rules Adopted by the
Commission in the Market for Listed
Securities
June 22, 2010.
Notice is hereby given, pursuant to
the provisions of the Government in the
Sunshine Act, Public Law 94–409, that
the Securities and Exchange
Commission will hold a Closed Meeting
on Thursday, July 1, 2010 at 2 p.m.
Commissioners, Counsel to the
Commissioners, the Secretary to the
Commission, and recording secretaries
will attend the Closed Meeting. Certain
staff members who have an interest in
the matters also may be present.
The General Counsel of the
Commission, or his designee, has
certified that, in his opinion, one or
more of the exemptions set forth in 5
U.S.C. 552b(c)(3), (5), (7), 9(B) and (10)
and 17 CFR 200.402(a)(3), (5), (7), 9(ii)
and (10), permit consideration of the
scheduled matters at the Closed
Meeting.
Commissioner Casey, as duty officer,
voted to consider the items listed for the
Closed Meeting in a closed session.
The subject matter of the Closed
Meeting scheduled for Thursday, July 1,
2010 will be:
Institution and settlement of injunctive
actions;
Institution and settlement of
administrative proceedings;
Consideration of amicus participation;
An opinion; and
Other matters relating to enforcement
proceedings.
At times, changes in Commission
priorities require alterations in the
scheduling of meeting items.
For further information and to
ascertain what, if any, matters have been
I. Introduction
On August 7, 2009, the Financial
Industry Regulatory Authority, Inc.
(‘‘FINRA’’) filed with the Securities and
Exchange Commission (‘‘Commission’’),
pursuant to Section 19(b)(1) of the
Securities Exchange Act of 1934
(‘‘Act’’) 1 and Rule 19b–4 thereunder,2 a
proposed rule change to establish
certain regulatory protections for the
market for OTC Equity Securities 3 that
are similar to those established for
national market system securities by
Regulation NMS.4 The proposed rule
change was published for comment in
the Federal Register on August 26,
2009.5 The Commission received 12
comments on the Initial Notice.6 On
James E. Rivera,
Associate Administrator for Disaster
Assistance.
[FR Doc. 2010–15681 Filed 6–28–10; 8:45 am]
BILLING CODE 8025–01–P
PO 00000
Frm 00114
Fmt 4703
Sfmt 4703
1 15
U.S.C. 78s(b)(1).
CFR 240.19b–4.
3 See FINRA Rule 6420(d) (defining OTC Equity
Security as ‘‘any non-exchange-listed security and
certain exchange-listed securities that do not
otherwise qualify for real-time trade reporting’’).
Pursuant to Securities Exchange Act Release No.
61979 (April 23, 2010), 75 FR 23316 (May 3, 2010),
effective June 28, 2010, the term OTC Equity
Security will be defined in FINRA Rule 6420(c) as
‘‘any equity security that is not an ‘NMS stock’ as
that term is defined in Rule 600(b)(47) of Regulation
NMS; provided, however, that the term ‘‘OTC
Equity Security’’ shall not include any Restricted
Equity Security.’’
4 17 CFR 242.600 et seq.
5 See Securities Exchange Act Release No. 60515
(August 17, 2009), 74 FR 43207 (‘‘Initial Notice’’).
6 See Submission via SEC WebForm from
anonymous, dated September 1, 2009; Letter to
Nancy M. Morris, Commission, from Janet M.
Kissane, Senior Vice President—Legal and
Corporate Secretary, NYSE Euronext, dated
September 23, 2009 (‘‘ArcaEdge Letter’’); Letter to
Elizabeth M. Murphy, Secretary, Commission, from
2 17
E:\FR\FM\29JNN1.SGM
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Agencies
[Federal Register Volume 75, Number 124 (Tuesday, June 29, 2010)]
[Notices]
[Pages 37483-37488]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-15734]
-----------------------------------------------------------------------
NUCLEAR REGULATORY COMMISSION
[NRC-2010-0209]
Request for Comments on the Draft Policy Statement on the
Protection of Cesium-137 Chloride Sources and Notice of Public Meeting
AGENCY: Nuclear Regulatory Commission (NRC).
ACTION: Request for public comment and notice of public meeting.
-----------------------------------------------------------------------
SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) is considering
adopting a statement of policy on the protection of cesium-137 chloride
(CsCl) sources. This statement would provide the Commission's policy
regarding secure uses of these sources at the present and express the
Commission's potential actions in the event that changes in the threat
environment necessitate these actions. The purpose of this policy
statement is to delineate the Commission's expectations for security
and safety of these sources. This draft policy statement is being
issued for public comment.
Additionally, the NRC is conducting a public meeting to solicit
public input on major issues associated with the draft policy statement
regarding the current use of certain forms of Cs-137 sources used by
NRC- and Agreement State-licensees. Furthermore, the NRC is requesting
names of individuals to participate at the public meeting in separate
roundtable panel discussions of the issues identified in Sections III
and IV of this notice.
DATES: 1. Comments on the draft policy statement should be submitted by
December 17, 2010. Comments received after this date will be considered
if it is practical to do so, but the NRC is able to assure
consideration only for comments received on or before this date.
2. Nominations for participation in the roundtable discussions of
the public meeting should be submitted by October 8, 2010. For
expeditious handling of the nominations, the NRC established a
dedicated e-mail address. The nominations should be sent to the
following NRC e-mail address: CesiumDraftPolicy@nrc.gov.
3. Other participants, who wish to attend the public meeting, could
also pre-register at the dedicated e-mail address:
CesiumDraftPolicy@nrc.gov. The Commission will appreciate pre-
registration in order to properly plan for the conference facilities.
However, pre-registration is not required and pre-registration is open
until the opening day of the public meeting.
Public Meeting Dates: The NRC will take public comments on the
issues raised in this document at a public meeting on November 16-17,
2010. The location of the public meeting has not been finalized.
However, the location is planned to be near the NRC Headquarters in the
Rockville, Maryland, area. The location and the agenda of the public
meeting will be posted at the dedicated Web site https://www.nrc.gov/materials/miau/licensing.html#cc, as soon as this information is
finalized. Please refer to the SUPPLEMENTARY INFORMATION section for
additional information.
ADDRESSES: Please include Docket ID NRC-2010-0209 in the subject line
of your comments. For instructions on submitting comments and accessing
documents related to this action, see Section I, ``Submitting Comments
and Accessing Information'' in the SUPPLEMENTARY INFORMATION section of
this document. You may submit comments by any one of the following
methods.
Federal Rulemaking Web Site: Go to https://www.regulations.gov and
search for documents filed under Docket ID NRC-2010-0209. Address
questions about NRC dockets to Carol Gallagher, telephone (301) 492-
3668; e-mail Carol.Gallagher@nrc.gov.
Mail comments to: Cindy Bladey, Chief, Rules, Announcements and
Directives Branch, Office of Administration, MS: TWB-5 B1M, U.S.
Nuclear Regulatory Commission, Washington, DC 20555-0001.
[[Page 37484]]
FOR FURTHER INFORMATION CONTACT: Dr. John P. Jankovich, Office of
Federal and State Materials and Environmental Management Programs,
telephone (301) 415-7904, e-mail john.jankovich@nrc.gov, or Dr. Cynthia
G. Jones, Office of Nuclear Security and Incident Response, telephone
(301) 415-0298, e-mail cynthia.jones@nrc.gov.
SUPPLEMENTARY INFORMATION:
I. Submitting Comments and Accessing Information
Comments submitted in writing or in electronic form will be posted
on the NRC Web site and on the Federal rulemaking Web site https://www.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.
You can access publicly available documents related to this
document, including the following documents, 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, Room
O-1F21, One White Flint North, 11555 Rockville Pike, Rockville,
Maryland.
NRC's Agencywide Documents 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 https://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 or 301-415-4737, or by e-mail to
PDR.Resource@nrc.gov.
Federal Rulemaking Web Site: Public comments and supporting
materials related to this document can be found at https://www.regulations.gov by searching on Docket ID NRC-2010-0209.
II. Background
Certain radioactive sources, including CsCl sources, have been
identified by the International Atomic Energy Agency (IAEA) Code of
Conduct on the Safety and Security of Radioactive Sources (Code of
Conduct) (see https://www-pub.iaea.org/MTCD/publications/PDF/Code-2004_web.pdf) as sources that may pose a significant risk to individuals,
society, and the environment if improperly handled or used in a
malicious act. Consequently, the NRC considers it prudent to express
its views on the safe and secure use of these sources. CsCl sealed
sources are used in many applications, most commonly in irradiators,
calibrators, and in devices for biological and medical research. To
develop its draft policy statement, the NRC initiated and completed a
number of initiatives. A significant element of these initiatives was
an Issue Paper which was published in the Federal Register on July 31,
2008 (73 FR 44780), and discussed with stakeholders in a public
workshop held on September 29-30, 2008. The NRC also received numerous
written comments on the issues. The oral and written comments as well
as the transcript of the workshop, along with other relevant
information, are accessible at https://www.nrc.gov/materials/miau/licensing.html#cesium.
The NRC is seeking public input on the major issues associated with
its policy involving CsCl to reduce the risk to individuals, society,
and the environment. As a first step, the NRC has prepared a draft
policy statement, contained in Section III of this document, which
describes issues related to safety and security associated with IAEA
Category 1 and 2 CsCl sources.\1\ The intent of this document is to
foster discussion about these issues and to solicit comments on the
draft policy statement. The NRC will also use a public Web site, https://www.nrc.gov/materials/miau/licensing.html#cc to make documents,
relevant to the draft policy statement and to the public meeting,
accessible. This public Web site will be continually updated as new
information becomes available. The exact location and the agenda of the
public meeting will also be posted at this site as soon as they become
finalized.
---------------------------------------------------------------------------
\1\ An IAEA Category 1 cesium-137 source contains a minimum of
3000 Ci (100 TBq) and a Category 2 source contains a minimum of 30
Ci (1 TBq). See https://www-pub.iaea.org/MTCD/publications/PDF/Code-2004_web.pdf.
---------------------------------------------------------------------------
III. Draft Policy Statement of the U.S. Nuclear Regulatory Commission
on the Protection of Cesium-137 Chloride Sources
The NRC's Role in Ensuring Security for Radioactive Materials
The NRC has the responsibility to license and regulate the civilian
use of radioactive materials for commercial, industrial, academic, and
medical purposes in a manner that protects public health and safety and
promotes the common defense and security. The NRC and its predecessor,
the Atomic Energy Commission, have regulated the use of radioactive
materials since 1946. The use of radioactive materials is regulated by
the NRC and 37 states, known as Agreement States. Agreement States
enter into agreements with the NRC under Section 274 of the Atomic
Energy Act to license and regulate the use of byproduct material within
their borders.
The security and control of radiation sources is an essential part
of the NRC's mission. The NRC's efforts in this regard continue to be
effective, and there have been no security incidents involving risk-
significant radiation sources. After September 11, 2001, the NRC
imposed additional security requirements. In addition, the National
Nuclear Security Administration (NNSA) has initiated a program to
enhance security voluntarily beyond these requirements. One type of
radioactive source, cesium-137 chloride (CsCl), has been the focus of
increased attention in the U.S. because these sources are extensively
used in a wide range of applications in medicine, industry, and
research and, while unlikely, due to the physical and chemical
characteristics of CsCl, these sources could be used by terrorists in a
radiological dispersal device or ``dirty bomb.''
The NRC supports and implements the recommendations of the
international community regarding the safe use and protection of
radioactive materials. In 2004, the International Atomic Energy Agency
(IAEA) issued the Code of Conduct for the Safety and Security of
Radioactive Sources (the Code), which prescribes a legislative
framework, regulatory programs, and import/export provisions to achieve
and maintain a high level of safety and security of radioactive
sources. The U.S. Government is committed to the implementation of the
Code. The Code applies to all radioactive sources that could pose a
significant risk to individuals, society, and the environment. The Code
establishes five categories of radioactive sources based on their
potential to cause severe
[[Page 37485]]
deterministic health effects if not managed in a safe and secure
manner. Consistent with the Code, the NRC and the Agreement States have
established national requirements for the enhanced security for
Category 1 and 2 quantities of radioactive material, which, if misused,
could pose a significant risk to individuals, society, and the
environment.
To maintain security of sources, the Energy Policy Act of 2005
(EPAct) directed the NRC to establish and lead the Radiation Source
Protection and Security Task Force (Task Force) to evaluate and provide
recommendations to the President and Congress periodically relating to
the security of radiation sources in the U.S. from potential terrorist
threats, including acts of sabotage, theft, or use of a radiation
source in a radiological dispersal device. The EPAct named 12 Federal
agencies to the Task Force. In addition to the named agencies, the NRC
invited the U.S. Department of Health and Human Services and the White
House Office of Science and Technology Policy to participate. To
accomplish the mission in view of the regulatory responsibilities
divided in the U.S. between the NRC and the Agreement States, the Task
Force also invited a representative of the Organization of Agreement
States and the Conference of Radiation Control Program Directors to
participate as a non-voting member. NRC has coordinated with these
partners consistent with its regulatory role, to enhance the security
of sources, including CsCl. The Task Force issued its first report in
2006,\2\ and is scheduled to issue another report in 2010. The NRC's
security requirements for radioactive sources are aligned with the
recommendations of the first Task Force report.
---------------------------------------------------------------------------
\2\ Report to the President and the U.S. Congress Under Public
Law 109-58, The Energy Policy Act of 2005, The Radiation Source
Protection and Security Task Force Report, NRC Reference No.
ML062190349.
---------------------------------------------------------------------------
Statement of Policy
It is the policy of the Commission that its mission of ensuring
adequate protection of public health and safety, common defense and
security, and the environment while enabling the use of radioactive
materials for beneficial civilian purposes is best accomplished with
respect to CsCl by implementing or promoting the following principles:
The safety and security of risk significant sources is an
essential part of the NRC's mission;
Licensees have the primary responsibility to securely
manage and to protect sources in their possession from misuse, theft,
and radiological sabotage;
Adequate protection of public health and safety is
maintained if CsCl sources are managed in accordance with the security
requirements of the NRC and the Agreement States. These requirements
are based on vulnerability assessments of the various sources and
follow the principles of the Code of Conduct on the Safety and Security
of Radioactive Sources of the International Atomic Energy Agency;
While these sources are adequately protected under the
current NRC requirements, design improvements could be made that
further mitigate or minimize the radiological consequences;
The development and use of alternative forms of cesium-
137, while not required for adequate protection, is prudent and the NRC
intends to monitor these developments closely. In addition, the NRC
recognizes that measures to verify effectiveness of the alternatives
for solubility and dispersibility must be established to support future
decision-making on this matter;
CsCl enables three specific classes of applications that
benefit society: (a) Blood irradiation, (b) bio-medical and industrial
research, and (c) calibration of instrumentation and dosimetry;
The NRC recognizes that currently there is no disposal
capability for such commercial sources. The NRC considers it imperative
to develop a pathway for the long term storage and disposal of these
sources whether or not there are alternatives developed; and
The NRC monitors the threat environment and maintains
awareness of international and domestic security efforts. In the event
that changes in the threat environment necessitate regulatory action,
the NRC is ready to issue additional security requirements to apply
appropriate limitations for the use of CsCl in its current form.
Background
Security and Control of Radioactive Sources
Strong measures and regulatory requirements are currently in place
for ensuring security and control of radioactive sources. After the
terrorist events of September 11, 2001, the NRC and Agreement States
issued security requirements mandating that licensees who possess IAEA
Category 1 or 2 quantities of radioactive materials implement increased
security and control measures to reduce the risk of malevolent use and
intentional unauthorized access to radioactive material. The additional
requirements enhanced and supplemented existing regulations in 10 CFR
20.1801, ``Security of Stored Material,'' and 10 CFR 20.1802, ``Control
of Material Not in Storage,'' which are primarily intended to prevent
or mitigate unintended exposure to radiation.
Current security requirements include access controls and
background checks for personnel; monitoring, detecting and responding
to unauthorized access; delay; advance coordination with local law
enforcement; and the tracking of transfers and shipments. The security
requirements require licensees to establish and implement
trustworthiness and reliability standards to determine who will have
unescorted access to the radioactive material. An individual's
trustworthiness and reliability is based upon a background
investigation. The NRC and Agreement States have jointly developed
materials protection and security regulatory requirements that reflect
the experience gained through implementation of existing requirements.
In addition, the NRC has implemented new regulatory requirements
for import/export licensing and for reporting to the National Source
Tracking System (NSTS) which increase accountability of Category 1 and
2 radioactive material transactions and help to ensure that such
transactions are only made by authorized entities. The NRC developed
and maintains the NSTS, which provides information on sources from the
time of manufacture through transportation and use to end-of-life
disposition. The NSTS and other systems under development, such as Web-
Based-Licensing and License Verification System, are key components of
a comprehensive program for the security and control of radioactive
materials. When complete, these systems will include information on all
NRC, Agreement State, and import/export licensees and high risk
radioactive sources.
The measures described above are in place to ensure the security of
all Category 1 and 2 radioactive sources, including CsCl sources. These
measures have reduced the vulnerability of CsCl sources. In addition,
the NRC and Agreement States are supporting the U.S. Department of
Energy's (DOE's) NNSA voluntary program to retrofit existing CsCl
irradiators with physical security enhancements and to incorporate
these improvements into the designs of newly manufactured units. These
modifications extend beyond current regulatory requirements. These
efforts are often complemented by expert security guidance to licensees
[[Page 37486]]
(assist visits) and table-top exercises that allow participants to
share best practices.
The NRC and Agreement States also support the Federal Bureau of
Investigation's ongoing Weapons of Mass Destruction (WMD)
countermeasure effort to reach out to certain communities of licensees
(including the CsCl irradiator licensee community). A critical aspect
of this WMD countermeasure effort is information sharing through visits
to licensees. These visits encourage communication and allow
regulators, law enforcement, and licensees to gain an understanding of
a licensee's security arrangements and how and when law enforcement
would be engaged if there were a threat or an event at a licensee's
site.
The NRC supports the security initiatives of international
organizations (e.g., IAEA), and other countries, as well as the
initiatives of Federal agencies aimed to further increase the
protection of high risk sources overseas (e.g., NNSA's Global Threat
Reduction Initiative). The NRC participates in the development of such
protective measures in various international forums and will consider
their applicability for use within the U.S. if the threat environment
changes, warranting additional protective measures.
Uses of CsCl Sources
CsCl sources comprise approximately 3% of the IAEA Category 1 and 2
quantity sources in the U.S. Many in the medical and scientific
communities indicate that these CsCl sources are important due to their
application in blood irradiation, bio-medical and industrial research,
and calibration of instrumentation and dosimetry, especially for
critical reactor and first responder equipment. CsCl is used for these
applications because of the properties of the nuclide cesium-137 (Cs-
137), including its desirable single energy spectrum (662 keV), long
half-life, low cost, and moderate shielding requirements relative to
other nuclides. The CsCl used in these applications is in a compressed
powder form that is doubly-encapsulated in two stainless steel capsules
to ensure safety and security in normal use. This physical form is used
because of its high specific activity (gamma emission per unit volume)
and manufacturability. However, the powder is highly soluble and
dispersible, which presents security concerns.
Blood irradiation is medically essential to prevent transfusion-
associated Graft-Versus-Host disease, and some hospitals use only
irradiated blood. CsCl blood irradiators are used in over 90% of all
blood irradiation because they are the most reliable and efficient
blood irradiation devices currently available.
In biomedical research, CsCl irradiation has been used for over 40
years in fields such as immunology, stem cell research, cancer
research, in-vivo immunology, systemic drug research, chromosome
aberrations, DNA damage/repair, human genome, and genetic factors. For
most research there are no alternatives to Cs-137 irradiation because
of the unique properties of Cs-137 radiation, such as high dose rates
with uniform fields of linear energy transfer. No alternative
technologies that can effectively replace CsCl sources for biomedical
research have yet been developed.
The U.S. and international systems of radiation measurements are
based on the energy spectrum of Cs-137. All American National Standards
Institute standards and their associated test-and-evaluation protocols
for radiation detection, instrumentation, and personal dosimetry rely
on the use of Cs-137. In addition, all DHS-related standards for
calibration of first responder and emergency response equipment, such
as personnel self-reading dosimeters, portal monitors, and portable
survey instruments, also require the use of Cs-137 for calibration
purposes. Cs-137 was selected by the U.S. and the international
community as the basis of calibration because of the optimal single
energy spectrum of this nuclide and its long half-life. The National
Institute of Standards and Technology (NIST) maintains the national
measurement standards and calibrates the instruments for secondary
laboratories. These instruments are sent to secondary and tertiary
laboratories that, in turn, calibrate the instruments for end users.
This network of facilities ensures that every radiation detection
instrument that is used in the country measures correctly and is
traceable to NIST.
Ensuring Secure Disposal for Disused CsCl Sources
The disposal of CsCl radioactive sources, which are currently in
use, is a challenge because of the high cost of disposal and the lack
of commercial disposal facilities. The vast majority of the CsCl
sources in use today are classified as Greater-Than-Class C low-level
radioactive waste. Today, used and unwanted CsCl sources are stored
safely and securely at the users' sites under the applicable NRC and
Agreement State control and security requirements until commercial
options become available. To maintain source safety and security, the
sites are routinely inspected in accordance with established NRC and
Agreement State inspection procedures. The Commission considers it
imperative to develop a pathway for the long term storage and disposal
of these sources because long term storage at licensee facilities
increases the potential for safety and security issues. To resolve
these issues, the NRC will continue to participate with its Federal and
State partners and representatives of the private sector in initiatives
to explore medium- and long term-solutions to address the need for
disposal and disposition of CsCl sources.
The Low-Level Radioactive Waste Policy Amendments Act of 1985
assigned responsibility for providing disposal of this type of waste to
DOE. However, pending the availability of a disposal capability, DOE is
not responsible for accepting disused sources for storage,
transportation or other activities related to disposal except under
special circumstances.\2\ At the present time, no final decision has
been made to proceed with approval, funding, and operation of a
disposal facility. The Commission will actively support DOE in all
phases of the process to establish a storage facility for permanent,
safe and secure storage of used and unwanted sources.
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\2\ Under specified circumstances, and pursuant to other
authority and responsibility under the Atomic Energy Act of 1954,
DOE may recover excess or unwanted sealed sources (including CsCl
sources) for reuse, storage or disposal that present threats to
public health, safety or national security.
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The NRC's Perspective on Further Security Enhancements
The NRC believes that the current enhanced regulatory framework for
security of radioactive sources has been very effective in enhancing
and ensuring the security and control of risk-significant sources used
in medical, industrial, and research activities in the U.S. The NRC
encourages stakeholders to take an active role in source security and
continue their efforts in maintaining the current security environment.
As is necessary and practical, and in response to any change in the
threat environment, the NRC will work with other Federal agencies to
further enhance the secure use of Cs-137 sources. The NRC recognizes
that it is prudent to maintain awareness of the status of research to
identify alternative forms of CsCl. NRC will remain cognizant of these
issues and appropriately consider whether there are safety and security
benefits to further risk reduction. As part of NRC's
[[Page 37487]]
responsibility to ensure the security of these sources, the NRC, in
coordination with its Federal partners, continuously monitors the
national threat environment and is prepared to take further regulatory
actions should this environment change. Just as it did following the
events following September 11, 2001, the NRC is prepared to take
immediate action such as issuance of additional security requirements
with orders or rulemaking to address such security-related issues, if
necessary.
The NRC solicits stakeholder input into major issues associated
with the use of CsCl. The Public Workshop on the Security and Continued
Use of Cesium-137 Chloride Sources that the NRC held in September 2008,
is an example of soliciting such input. The workshop was attended by a
large number of stakeholders and, in addition to the oral presentations
and comments, the NRC received a significant number of written
submissions. The workshop provided valuable information for the
formulation of this Policy Statement regarding the use of CsCl sources,
security issues, and the diversity of impacts that licensees could
experience as a result of potential further regulatory requirements.
While the current security requirements are adequate, the NRC
recognizes that if the use of CsCl in its current form is to continue,
the NRC encourages the source and device manufacturers to implement
design improvements that further mitigate or minimize the radiological
consequences of misuse or malevolent acts involving these sources given
that such events, while unlikely, cannot be dismissed. Similarly, the
NRC supports efforts to develop alternate forms of Cs-137 that would
further reduce the risk of malevolent use associated with CsCl. The
National Research Council of the National Academies (NA) issued a
report \3\ that supported these efforts, recommended that the NRC
consider the potential economic and social disruption that changes to
the CsCl requirements could cause, and supported a research and
development program for alternative ``matrices'' for high-activity Cs-
137 sources, which would provide lowered security hazards.
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\3\ National Research Council of the National Academies,
``Radiation Source Use and Replacement,'' The National Academies
Press, Washington, DC, https://www.nap.org.
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The NRC recognizes that objective measures of ``solubility'' and
``dispersibility'' need to be defined before alternate forms of Cs-137
that are less-soluble and less-dispersible than the compressed powder
form can be developed. The Commission has already directed the NRC
staff to work with Federal agencies to define these measures which must
be readily expressible in physical and chemical terms and be
demonstrated through well-defined test protocols. In addition, the
criteria for the solubility and the dispersibility measures must be
established at levels that ensure enhancement of security and reduction
of risks of malevolent use. Consequently, the criteria must be
developed and accepted by both the cognizant technical communities and
the communities responsible for the Nation's security.
While it is outside the scope of NRC's mission to conduct
developmental research, the Commission encourages stakeholder research
to develop alternative chemical forms for large activity Cs-137
sources. One of the recommendations made by the NA was to investigate
the development of alternate chemical forms of Cs-137. The NRC believes
that such research should engage cognizant Federal agencies and should
consider the practicality of producing an end product that would
maintain the security as well as the societal benefits of the current
applications of CsCl sources. The NRC considers that pursuit of
alternate forms of cesium would provide benefits in the longer term,
because the technology of manufacturing other forms of cesium is not
yet available. Given the state of the current technology, NRC believes
that, for the short term, it is more feasible to focus current security
efforts on strengthening existing security of sources as necessary
through cooperative efforts and voluntary initiatives of industries
that currently manufacture and use irradiators with CsCl sources. While
current NRC security requirements ensure the safety and security of
these sources, it has been shown through the voluntary NNSA security
initiative program that further security enhancements and future design
improvements further minimize the potential misuse or malevolent acts
involving these sources.
Summary
The NRC is continually working with its domestic and international
partners to assess, integrate, and improve its security programs, and
to make risk-significant radiation sources more secure and less
vulnerable to terrorists. The NRC has the responsibility to ensure the
safe and secure use and control of radioactive sources, including CsCl
sources. The NRC has met this responsibility through imposition of
additional security requirements. The NRC has articulated in the past
that the use of alternative forms of Cs-137 is desirable. The NRC's
actions to date have resulted in strong security measures being
established, and the NRC recognizes that near term replacement of
devices or CsCl sources in existing blood, research, and calibration
irradiators is not practicable or necessary due to implementation of
the additional requirements and considering a lack of a disposal
capacity. A clear strategy for the end-of-life management of these
sources, which is the responsibility of the DOE, is not mature and
likely will not be for some time. Many medical, research, and emergency
response stakeholders have indicated that short term replacement would
be detrimental. Therefore, the NRC continues to believe that the
security of these facilities should be maintained and enhanced as
practical through the implementation of the regulatory requirements and
through voluntary actions such as the physical security enhancements of
existing devices and future designs against intrusion. The NRC supports
efforts to develop alternate forms of Cs-137 that would reduce the
security risks and will monitor these developments closely. The NRC
will continue to work with its federal partners to ensure the safety
and security of CsCl sources. In the event that changes in the threat
environment necessitate regulatory action, the NRC is ready to issue
additional security requirements to apply appropriate limitations for
the use of CsCl in its current forms or for its replacement with
suitable alternatives.
IV. Plans for a Public Meeting
The NRC is holding a facilitated public meeting on November 16-17,
2010, on the draft policy statement and the following issues:
The NRC's role in ensuring security for radioactive
materials.
Statement of Policy.
Security and control of radioactive sources.
Uses of CsCl sources.
Ensuring secure disposal for disused CsCl sources.
NRC's perspective on further security enhancements.
During the public meeting, NRC will conduct roundtable panel
discussion, with opportunity for audience participation, for each issue
contained in Sections III and IV of this document. NRC is seeking the
names of individuals interested in participating on these panels.
Nominations by interested individuals or organizations should
[[Page 37488]]
include the name of the proposed panel member, the issues they are
interested in discussing, viewpoint(s) on the issue(s), and affiliation
(if any). Roundtable panel participants will be selected with the goal
of providing balanced viewpoints on each of the various issues. Please
see the DATES section to submit nominations by October 8, 2010.
We encourage previous participants who attended, either as panel
members or attendees, the prior public workshop, held on September 29-
30, 2008, to also participate in this meeting. Information on the
previous public meeting is accessible at https://www.nrc.gov/materials/miau/licensing.html#cesium.
Based on the comments received in both written and electronic form,
and at the public meeting, the Commission will then be in a better
position to proceed with the issuance of a final Policy Statement. The
final Policy Statement, when issued by the Commission, will be
published in the Federal Register.
Dated at Rockville, Maryland, this 22 day of June 2010.
For the Nuclear Regulatory Commission.
Cynthia Carpenter,
Deputy Director, Office of Federal and State Materials and
Environmental Management Programs.
[FR Doc. 2010-15734 Filed 6-28-10; 8:45 am]
BILLING CODE 7590-01-P