[Federal Register Volume 73, Number 148 (Thursday, July 31, 2008)]
[Notices]
[Pages 44780-44783]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-17545]
-----------------------------------------------------------------------
NUCLEAR REGULATORY COMMISSION
[NRC-2008-0419]
Request for Comments on the Security and Continued Use of Cesium-
137 Chloride Sources and Notice of Public Meeting
AGENCY: U.S. Nuclear Regulatory Commission (NRC).
ACTION: Notice of Public Meeting and a request for comment.
-----------------------------------------------------------------------
SUMMARY: The NRC is conducting a public meeting to solicit early public
input on major issues associated with the use of certain forms of
cesium chloride (CsCl) currently used by NRC- and Agreement State-
licensees. To aid in that process, the NRC is requesting comments on
the issues discussed in this notice. While the NRC has not initiated
rulemaking on this subject, we are utilizing the conventionally
established rulemaking comment channels. Additionally, the NRC is
requesting names of individuals to participate at the public meeting in
a roundtable discussion of the issues discussed in Sections II and III
of this notice.
DATES: Comment Dates:
1. Comments on this notice should be submitted by September 30,
2008. 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 discussion
should be submitted by September 1, 2008.
Public Meeting Dates: The NRC will also take public comments on the
issues raised in this notice at a public meeting on September 29-30,
2008. Please refer to the SUPPLEMENTARY INFORMATION section for
additional information.
ADDRESSES: Members of the public are invited and encouraged to submit
comments by mail to Michael Lesar, Chief, Rulemaking, Directives, and
Editing Branch, Office of Administration, Mail Stop T-6D59, U.S.
Nuclear Regulatory Commission, Washington, DC 20555-0001.
You may also submit comments electronically at http://www.regulations.gov; search on docket ID: NRC-2008-0419.
To ensure efficient and complete comment resolution, comments
should include references to the section and page numbers of the
document to which the comment applies, if possible. When commenting on
the CsCl issues presented in this notice, please exercise caution with
regard to site-specific security-related information. Comments will be
made available to the public in their entirety; personal information,
such as your name, address, telephone number, e-mail address, etc. will
not be removed from your submission.
You can access publicly available documents related to this notice
using the following methods:
Regulations.gov: Documents related to this notice, including public
comments, are accessible at http://www.regulations.gov, by searching on
docket ID: NRC-2008-0419.
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-1F21, One White Flint North, 11555 Rockville Pike,
Rockville, Maryland.
NRC's Agencywide Document Access and Management System (ADAMS):
Publicly available documents created or received at the NRC after
November 1, 1999, are available electronically at the NRC's Electronic
Reading Room at http://www.nrc.gov/reading-rm/adams.html. From this
site, 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 PDR Reference staff at 1-800-397-4209, 301-415-4737
or by e-mail to [email protected].
[[Page 44781]]
FOR FURTHER INFORMATION CONTACT: Dr. John P. Jankovich, Office of
Federal and State Materials and Environmental Management Programs,
telephone (301) 415-7904, e-mail [email protected], or Dr. Cynthia
Jones, Office of Nuclear Security and Incident Response, telephone
(301) 415-0298, e-mail [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
Certain radioactive 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 http://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. Federal agencies have
performed recent risk and consequence studies that show it may be
prudent to require additional security features for licensed facilities
that use certain radioactive material, including CsCl sources. CsCl
sealed sources are used in many applications, most commonly in
irradiators, calibrators, and in devices for biological and medical
research. A recent National Academy of Sciences study (NAS report) has
recommended the replacement or elimination of CsCl sources (see http://www.nap.edu/catalog.php?record_id=11976).
The NRC is seeking early public input on the major issues
associated with any potential regulatory actions involving CsCl that
would reduce the risk to individuals, society, and the environment if
such material were used in a malicious act. As a first step, the NRC
has prepared an Issues Paper, contained in Section III of this notice,
which describes issues and alternatives related to the overall concerns
associated with IAEA Category 1 and 2 CsCl sources.\1\ The intent of
this paper is to foster discussion about these issues and alternatives
before any regulatory actions by NRC or the Agreement States are
initiated. The NRC will also utilize a public Web site, http://www.nrc.gov/materials/miau/licensing.html to make documents relevant to
the Issues Paper available to the public. The content of the Issues
Paper is contained in Section III of this notice.
---------------------------------------------------------------------------
\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 http://www-pub.iaea.org/MTCD/publications/PDF/Code-2004_web.pdf.
---------------------------------------------------------------------------
II. Request for Written and Electronic Comments and Plans for a Public
Meeting
The NRC is soliciting comments on the items presented in the Issues
Paper. Comments may be submitted either in writing or electronically as
indicated under the ADDRESSES heading. In addition, the NRC is holding
a facilitated public meeting at the Bethesda North Marriott Hotel &
Conference Center, 5701 Marinelli Road, Bethesda, Maryland on September
29-30, 2008, on the issues discussed in Section III of this notice.
This Issues Paper provides background and topics of discussion on the
major issues that will be the subject of the public meeting.
During the public meeting, NRC will conduct individual roundtable
panel discussions, with opportunity for audience participation, on each
issue contained in Section III of this notice. NRC is seeking the names
of individuals interested in participating on these panels. Nominations
by interested individuals or organizations should include the name of
the proposed panel member, the issues they are interested in
discussing, view point(s) on the issue(s), and affiliation (if any).
Roundtable panel participants will be selected with the goal of
providing balanced view points on each of the various issues. Please
see the ADDRESSES section to submit nominations by September 1, 2008.
In addition to inviting public comments on the issues presented in
Section III of this notice, the NRC is also soliciting specific
comments related to: (1) Quantitative information on the costs and
benefits resulting from consideration of the factors described in the
Issues Paper; (2) operational data on radiation exposures (increased or
reduced) that might result from implementing any of the options
described in the Issues Paper; (3) whether the presented issues are
addressed comprehensively; and (4) whether other options should be
considered, including quantitative information on the costs and
benefits for these other options. The Commission believes that
stakeholder comments will help to quantify the potential impact of
these proposed changes and will assist the NRC as potential regulatory
action(s) are developed.
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 evaluate whether to proceed with the development of a
proposed rulemaking or take some other regulatory action. If the
Commission decides to proceed with a proposed rulemaking, additional
information will be published in the Federal Register for public review
and comment.
III. Issues Paper on the Use of CsCl Sources at NRC- and Agreement
State-Licensed Facilities
Introduction
Section A of this Issues Paper describes some general
considerations recently raised concerning the use of certain CsCl
sources at NRC- and Agreement State-licensed facilities. Section B of
the paper discusses the various alternatives and major issues that need
to be addressed before commencing any regulatory activities related to
the use of CsCl sources in the U.S.
A. Background
The Energy Policy Act of 2005 (EPAct) required the establishment of
an interagency Radiation Source Protection and Security Task Force
(Task Force) to be chaired by the NRC. The Task Force was charged with:
(1) Evaluating and providing recommendations relating to the security
of radiation sources in the United States from potential terrorist
threats, including acts of sabotage, theft, or use of a radiological
source in a radiological dispersal device; and (2) providing
recommendations for appropriate regulatory and legislative changes to
Congress and the President.
On August 15, 2006, the NRC provided the President and Congress
with the first Report documenting the efforts of the Task Force. The
report included 10 recommendations and 13 actions to improve source
security in the U.S. (see http://www.nrc.gov/reading-rm/doc-collections/congress-docs/correspondence/2006/president-08-15-2006.pdf). Recommendation 12-2 from this report focused on the security
of IAEA Category 1 and 2 radioactive sources containing CsCl.
Specifically, this recommendation stated that:
``The Task Force recommends that high priority be given to
conducting a study within 2 years to assess the feasibility of
phasing out the use of CsCl in a highly dispersible form. This study
should consider the availability of alternative technologies for the
scope of current uses, safe and secure disposal of existing
material, and international safety and security implications.''
Section 651 of the EPAct also required that the NRC enter into an
arrangement with the National Academy of Sciences (NAS) through which
NAS would review the civilian uses of radionuclide radiation sources
and study potential
[[Page 44782]]
replacements for sources that pose a high risk to public health or
safety in the event of an accident or attack. Considering technical and
economic feasibility and risks to workers, the NAS was asked to report
findings and recommendations on options for implementing the identified
replacements. The NAS completed its review in February 2008 (see http://www.nap.edu/catalog.php?record_id=11976) and stated that cesium-137
in the form of CsCl is a greater concern than other radiation sources
based on its dispersibility and its presence in populated areas across
the country. In view of the overall liabilities associated with
radioactive CsCl and the alternatives that are available now or
possible in the future to replace these radiation sources, the NAS
report concluded that high-activity CsCl sources should be replaced.
The NAS also recommended that ``Replacement of some radionuclide
radiation sources with alternatives should be implemented with caution,
ensuring that the essential functions that the radionuclide radiation
sources perform are preserved.'' The NAS also suggested options for
implementing the replacement, including discontinuation of licensing of
new CsCl irradiator sources and devices, prohibiting the export of CsCl
to other countries and incentives to decommission existing sources and
devices.
Accordingly, the NRC is providing the following key points for
consideration and discussion in order to obtain stakeholder input
before making any regulatory enhancements for the continued use of CsCl
sources.
B. Issues for Discussion
The following format is used in the presentation of the issues that
follow. Each issue is assigned a number, a short title, and a list of
questions and factors for consideration. These issues, questions and
factors are not meant to be a complete or final list, but are intended
to initiate discussion. Interested stakeholders are welcome to
recommend additions, deletions, or modifications to the key issues for
consideration and propose implementation considerations. These issues
and factors will serve as the basis for discussion at the public
meeting. All public feedback will be used in developing implementation
options for Commission consideration. Meeting participants and
commenters are strongly encouraged to read the NAS report before the
public meeting or providing comments.
Issue No. 1--Alternatives to the Use of Cesium Chloride (CsCl) Sources
The majority of self-shielded irradiators used in industrial
operations, instrument calibration, and biological/medical research,
are constructed with CsCl sources because of the suitable properties of
cesium-137 such as long half-life, low cost, and moderate shielding
requirements relative to other radionuclides. Currently, the physical
form of CsCl in sources with activity levels under consideration (i.e.,
IAEA Category 1 and 2) is compressed powder. The compressed powder form
is used because of its high specific activity (high gamma emission per
unit volume) making it feasible to manufacture high-activity sources in
a relatively small volume.
In considering Issue No. 1, alternatives to the use of CsCl sources
in compressed powder form, there are two main issues that should be
considered and discussed. Issue 1.1: Feasibility of the use of other
chemical or physical forms of cesium-137 (Cs-137) and Issue 1.2:
Feasibility of the use of isotopes other than Cs-137. Each of these
issues is presented below.
Issue No. 1.1: Feasibility of the Use of Other Forms of Cs-137
Q1.1-1. Are manufacturers currently considering the use of other
forms of cesium (other than CsCl)? If yes, what are such
considerations?
Q1.1-2. Is the use of other forms of cesium feasible? If so, please
describe desired methods and discuss any benefits or obstacles (e.g.,
intended function of source, costs, timeframe).
Q1.1-3. (a) Would the effect of density loading with different
forms of cesium preclude their use in existing devices? (b) Would it
require modification of existing devices?
Q1.1-4. Is it feasible that high-activity (e.g., IAEA Category 1
and 2) cesium sources will be available in alternative material forms?
If so, what is the estimated timeframe for manufacturing?
Q1.1-5. Since all the CsCl is manufactured in Mayak, Russia, is it
known if the cesium source producer can modify its production process?
Q1.1-6. Would other entities (in the U.S. or worldwide) engage in
manufacturing sources with alternative forms of Cs-137?
Issue No. 1.2: Feasibility of the Use of Isotopes Other Than Cs-137
Q1.2-1. (a) Can cobalt-60 (Co-60) be substituted for radioactive
CsCl for any applications? (b) If so, what types of applications? (c)
If not, why not?
Q1.2-2. Can the shielding challenges for Co-60 be addressed by
switching from lead shields to more effective tungsten or depleted
uranium shielding?
Note: Consider that tungsten shielding is more expensive than
lead and manufacturing depleted uranium shielding is a very
specialized, expensive operation that requires NRC or Agreement
State licensing for its entire lifecycle.
Q1.2-3. What are the attendant risks associated with Co-60 source
transportation?
Note: Consider the shorter half-life (5.27 y) of Co-60 radiation
sources would require that they be replaced more frequently that Cs-
137, which entails the transportation of both fresh and used
sources.
Issue No. 2--Use of Alternatives Technologies
An alternative technology is defined in the context of this
document as a technological process that provides the same societal
benefits as the devices that utilize CsCl at the present time, but
without the use of radionuclides. Some of the potentially feasible
alternative technologies include such processes as x-ray irradiators or
electron beam irradiators. Previous reports, such as those prepared by
the Radiation Source Protection and Security Task Force and the NAS,
referenced above, addressed the issue of alternative technologies to a
limited extent. A more extensive examination of the feasibility of
these and other alternative technologies is needed.
Therefore, in considering Issue No. 2, use of alternative
technologies, there are four main issues that should be considered and
discussed:
Q2-1. Are X-ray generators already commercially available as
substitutes for applications that do not require the gamma rays with
Cs-137 and Co-60?
Q2-2. Are X-ray tubes cost-effective considering the initial cost,
operating costs, and requirements for more maintenance for periodic
calibration and replacement than radioactive sources?
Q2-3. Is there any indication that the performance of the
alternatives will change (improve or worsen) with respect to Cs-137?
Q2-4. Regarding the availability of alternative technologies, (a)
what is the timeframe of future availability of each alternative, and
(b) what is the cost for each of the alternative technologies (capital
costs, operation costs, cost to users)?
Issue No. 3--Possible Phase-Out of CsCl Sources
Discontinuation of the further use of CsCl sources with activity
levels in IAEA Category 1 and 2 was
[[Page 44783]]
recommended for consideration by the Radiation Source Protection and
Security Task Force and by the NAS, referenced above.
Both reports recognize the important role that devices, containing
such sources, fulfill in serving public health, research and instrument
calibration at the present time. But the reports also considered the
potential risks associated with these sources and, consequently,
recommended phasing out their future use. NRC has not made any decision
in this regard, but as a follow-up to the recommendations, NRC is
seeking additional information that would provided relevant information
for its decisionmaking process.
In considering Issue No. 3, possible phase-out of CsCl sources,
there are four main issues that should be considered and discussed:
Issue 3.1: Potential rulemaking issues and justification for regulatory
change; Issue 3.2: Transportation and storage issues associated with
removal of CsCl sources from licensee facilities; Issue 3.3:
Consideration of government incentives and voluntary actions by
industry and manufacturers; and Issue 3.4: Impact of U.S. changes to
regulating CsCl on the international community. Each of these issues
are presented below.
Issue No. 3.1: Potential Rulemaking Issues and Justification for
Regulatory Change
Q3.1-1. (a) What would be the medical consequences if CsCl was to
be banned for medical (e.g., blood) irradiators? (b) What would be the
impact to existing and future biomedical research using these devices?
(c) Can alternative technologies be used for medical applications and/
or biomedical research (research on animals and tissue?)
Q3.1-2. (a) What would be the consequences if CsCl was to be banned
for irradiators that are used for industrial and calibration purposes?
(b) What is the impact on existing American National Standards
Institute (ANSI) standards and licensee conditions that require the use
of Cs-137 for calibration purposes?
Q3.1-3. What would be the economic consequences to users if CsCl
was to be banned?
Q3.1-4. What would be the economic consequences to vendors if CsCl
was to be banned?
Q3.1-5. (a) Should the NRC discontinue all new licensing and
importation of these sources and devices? (b) What is the regulatory
basis? (c) Who (NRC, DHS, or jointly) should conduct the risk analysis?
Issue No. 3.2: Transportation and Storage Issues Associated With
Removal of CsCl Sources From Licensee Facilities
Q3.2-1. (a) Are there transportation packages available for
transportation? (a) Who should bear the transportation costs?
Q3.2-2. (a) How could the current CsCl sources be disposed given
that CsCl is defined as a ``Greater Than Class C'' source and currently
has no disposal mechanism in the U.S.? (b) If disposal was made
available by DOE, what would be the cost of disposal?
Q3.2-3. (a) Where could the decommissioned sources be stored? (b)
What disposition options are needed in the United States?
Issue No. 3.3: Consideration of Government Incentives and Voluntary
Actions by Industry and Manufacturers
Q3.3-1. Should the Federal government issue incentives to implement
replacements?
Q3.3-2. (a) Are there feasible incentives to shift users away from
radioactive CsCl for users? (b) Manufacturers?
Q3.3-3. (a) What incentives should the Federal government provide
to licensees to decommission their existing sources or devices because
the devices still have use value? (b) For licensees that are defined as
``not-for-profit'' (e.g., hospitals), what type of incentives could be
made available to change technologies?
Q3.3-4. How can the Federal government compensate licensees when
they are forced to decommission these sources? Should compensation
include the cost of the replacement technology? Decommissioning?
Issue No. 3.4: Impact of Potential U.S. Changes to Regulating CsCl on
the International Community
Q3.4-1. How can the U.S. prevent recovered sources from
decommissioned devices (or the devices themselves) from being sold
outside the U.S.?
Q3.4-2. (a) If the U.S. decides to ban the use of CsCl sources,
should the U.S. have a position in denying or eliminating after-market
sales of CsCl irradiators outside the U.S.? (b) Would this be
potentially denying medical care to developing countries?
Q3.4-3. What should the role of the International Atomic Energy
Agency (IAEA) be in assisting the U.S. in ensuring the safe and secure
use of CsCl sources and devices?
Issue No. 4--Additional Requirements for Enhanced Security of CsCl
Sources
In considering Issue No. 4, additional requirements for enhanced
security of CsCl sources, there are three main issues that should be
considered and discussed:
Q4.1. Should the NRC and Agreement States require more stringent
security measures than those currently mandated (e.g., should
additional requirements be implemented for IAEA Category 1 and 2
sources)?
Note: The current requirements for increased security of certain
high-risk radioactive sources in the U.S. are: (a) Compensatory
Measures for panoramic irradiators; (b) Additional Security Measures
for manufacturers and distributors; (c) Increased Controls for
licensees with Category 1 and 2 devices and sources; (d)
Fingerprinting for access to radioactive material (see http://www.nrc.gov/security/byproduct/orders.html).
Q4.2. Should the NRC and Agreement States require more stringent
security measures for lower than Category 2 CsCl sources and devices
(e.g., Category 3 sources)?
Q4.3. Would additional security requirements for CsCl create a
disincentive for owning them?
Issue No. 5--Role of Risk Analysis in Potential Future CsCl
Requirements
In considering Issue No. 5, the role of risk analysis in NRC and
Agreement State requirements for CsCl, the main issues that should be
considered and discussed:
Q5.1. (a) How should the NRC determine the economic and social
disruptions/impacts to the public, licensees, and the environment? (b)
How should these factors be measured in decision making?
Dated at Rockville, Maryland, this 24th day of July 2008.
For the Nuclear Regulatory Commission,
John P. Jankovich,
Team Leader, Office of Federal and State Materials and Environmental
Management Programs.
[FR Doc. E8-17545 Filed 7-30-08; 8:45 am]
BILLING CODE 7590-01-P