[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]


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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.

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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.
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    \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.
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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]
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