U.S. Nuclear Office of Nuclear NUREG/BR-0177

Regulatory Material Safety No. 03-4

Commission and Safeguards December 2003

NMSS Licensee Newsletter

NMSS Licensee Newsletter

(December 2003)

Contents Page

1. NRC Continues Efforts to Enhance

Security of Radioactive Materials

Through Issuance of Orders............................... 1

2. Recent Evaluations of the

Decommissioning Program ............................... 1

3. NMSS Responds to Davis-Besse

Lessons Learned................................................ 3

4. Proposed Rule to Amend

10 CFR Part 35, “Medical Use of

Byproduct Material” .......................................... 4

5. Generic Communications Issued

(September 10, 2003 - November 6, 2003) ........ 4

6. Significant Enforcement Actions ....................... 6

7. Significant Events ............................................. 8

8. Selected Federal Register Notices

(October 1, 2003 - November 30, 2003) ............ 9

NRC CONTINUES EFFORTS TO

ENHANCE SECURITY OF

RADIOACTIVE MATERIALS

THROUGH ISSUANCE OF ORDERS

In late October 2003, the U.S. Nuclear Regulatory

Commission (NRC) forwarded special

correspondence to licensees, communicating

Modified Safeguards Handling requirements

necessary for receiving safeguards-sensitive Orders,

which NRC is going to issue to licensees. In late

November 2003, NRC proceeded to issue a draft

Safeguards-Modified Handling Order to the highrisk group of materials licensees known as

manufacturing and distributing facilities, to improve

security of radioactive materials. This Order

included draft Additional Security Measures

(ASMs) concerning the security of high-risk

radioactive sources, and associated guidance for

implementing the ASMs. The ASMs and guidance

were drafted through a collaborative effort of NRC

and State representatives tasked to develop

additional materials security requirements in

response to the events of September 11, 2001.

During the week of December 8, 2003, NRC held a

series of closed workshops with NRC licensees and

Agreement State licensees, to discuss comments on

the draft ASMs. NRC staff plans to issue the final

implementing Orders by the end of December 2003.

(Contact: Rich Turtil, NMSS, 301-415-0260,

e-mail: rht@nrc.gov)

RECENT EVALUATIONS OF THE

DECOMMISSIONING PROGRAM

A. Results of License Termination Rule Analysis

The U.S. Nuclear Regulatory Commission’s

(NRC’s) experience from using the License

Termination Rule (LTR), since it was finalized in

1997, has revealed some important implementation

issues impacting the decommissioning of NRC

licensed sites. As a result, NRC conducted an

analysis of LTR issues. The analysis of issues and

recommendations was given to the Commission on

May 2, 2003 (SECY-03-0069). On November 17,

2003, the Commission approved the implementation

of the staff’s recommendations. The LTR Analysis

in SECY-03-0069 is publicly available on NRC’s

web site at http://www.nrc.gov/reading-rm/doccollection/commission/secys/2003.

The LTR Analysis particularly emphasized

resolving the institutional control issue so that the

restricted release and alternate criteria provisions of
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the LTR would be more available for licensee use.

In addition to the institutional control issue, NRC

also evaluated issues dealing with the relationship of

the LTR release limits to other release limits,

realistic exposure scenarios, measures to prevent

future legacy sites, and intentional mixing. For each

issue, NRC evaluated a range of options that could

resolve the issue and then recommended a preferred

option for Commission decision. For example,

NRC is planning on using the following options to

resolve the institutional control issue: 1) a riskinformed, graded approach for selecting institutional

controls; 2) NRC monitoring institutional controls

after license termination using a legal agreement

and a deed restriction; and 3) NRC long-term

control possession-only license. For the realistic

exposure scenario issue, NRC is planning on using

reasonably foreseeable future land uses, as opposed

to defaulting to very conservative scenarios such as

the resident farmer. Finally, many of the existing

decommissioning sites that NRC regulates are

complex and difficult to decommission for a variety

of financial, technical, or programmatic reasons.

NRC evaluated the lessons from these existing

“legacy” sites and plans on changes to financial

assurance and licensee operations, to minimize or

prevent future legacy sites.

NRC is planning a variety of regulatory actions to

address these issues, including: 1) a rulemaking for

measures to prevent future legacy sites (changes to

financial assurance and licensee operations);

2) revised guidance to support the rulemaking and

to clarify institutional controls for restricted use,

on-site burials, and realistic exposure scenarios;

3) revised inspection procedures and enforcement

guidance to enhance monitoring and reporting; and

4) a Regulatory Issue Summary to inform a wide

range of stakeholders about the LTR analysis of

each issue, Commission direction, and actions

planned to resolve each issue.

B. Decommissioning Program Evaluation

The U.S. Nuclear Regulatory Commission’s

(NRC’s) Strategic Plan for fiscal year (FY) 2000-

2005 identified a program evaluation entitled

Changes to the Decommissioning Process, to be

conducted in FY 2003. The NRC staff completed

its evaluation in FY 2003 and the results are

summarized below. The final report is available on

NRC’s Decommissioning web site, at http://

www.nrc.gov/materials/decommissioning.html.

The objectives of the Decommissioning Program

Evaluation were to: 1) evaluate the effectiveness of

NRC’s Division of Waste Management (DWM)

Decommissioning Program; 2) evaluate individual

program changes/improvements; and 3) recommend

future improvements. The scope of this program

evaluation was limited to the regulation of

decommissioning of nuclear materials facilities and

fuel cycle facilities included on the Site

Decommissioning Management Plan (SDMP) and

complex site list during the FY 2001–FY 2003 time

period. Also included within the scope of the

program evaluation were those activities related to

power reactor decommissioning that DWM was

responsible for before the transfer of most power

reactor decommissioning from the Office of Nuclear

Reactor Regulation to the Office of Nuclear

Material Safety and Safeguards during FY 2003.

The staff believes that the Decommissioning

Program has been effective at meeting the Agency’s

strategic and performance measures and removing

sites from the SDMP list after completion of

decommissioning and license termination. The

program also effectively used many types of selfassessments and program changes to improve the

regulatory framework, decommissioning processes,

internal program management processes, and public

involvement. The staff believes these improvements

have been useful and those that are ongoing should

continue to be used.

The Program Evaluation also made recommendations

to program managers that would improve internal

program management. These recommendations

include:

1) Establish a comprehensive

Decommissioning Program perspective.

2) Implement the new Consolidated

Decommissioning Guidance.

3) Improve staff availability and efficient

utilization.

4) Expand management reviews of all

decommissioning sites.

5) Compare and evaluate NRC’s

Decommissioning Program to

similar programs.

6) Revise Annual Budget measures and targets.

7) Consider using incentives to facilitate

licensee decommissioning.

8) Document and implement a continual

improvement plan.

(Contact: Robert L. Johnson, 301-415-7282, e-mail:

rlj2@nrc.gov)
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NMSS RESPONDS TO DAVIS-BESSE

LESSONS LEARNED

Over the past year and a half, the U.S. Nuclear

Regulatory Commission (NRC) has been responding

to the discovery of a corrosion-induced cavity in the

reactor vessel head at the Davis-Besse Nuclear

Power Station, located near Toledo, Ohio. The

Davis-Besse reactor head damage represented a

significant reduction in the safety margin of one of

the plant’s three barriers that separate radioactive

reactor fuel from the public and the environment.

One of the actions NRC undertook in response to

the discovery of the cavity was to charter a Lessons

Learned Task Force (LLTF) to independently

evaluate NRC’s regulatory processes, to identify

and recommend areas for improvement that may be

applicable to either NRC or the nuclear industry.

The LLTF identified several reasons that the vessel

head degradation was not prevented, including:

• NRC, the licensee, and the nuclear industry

failed to adequately review, assess, and follow

up on relevant information pertaining to

operating experience.

• The licensee failed to assure that plant safety

issues would receive appropriate attention.

• NRC failed to integrate known or available

information into its assessments of the

licensee’s safety performance.

The LLTF made several recommendations on how

NRC could improve its oversight of licensed

activities. In response to these recommendations, a

Senior Management Review Team evaluated the

LLTF report, and the results of its review were

transmitted to the Commission in a January 3, 2003,

memorandum from the Executive Director for

Operations (accessible from the NRC website or

through ADAMS at accession number

ML023600434). The second attachment to that

memorandum contains a table showing the Office of

the Nuclear Material Safety and Safeguards Areas

(NMSS) “Areas for Assessment,” grouped in the

following categories:

• Integrated assessment of nuclear material safety

programs

• Analysis and use of operating experience

information

• Use of risk in regulatory decisions

• Verification of the adequacy of licensee and

regulatory actions

• Implementation of management expectations

• NRC staffing and training

• Licensee self-assessment and corrective action

programs

NMSS divisions are addressing the “Areas for

Assessment” on program-specific bases. Some of

the activities that are being undertaken include:

• Examining ways to improve the evaluation of

operating experience, including ways to best

communicate lessons from events, generic

issues, results from analyses of performance and

trends, and safety insights.

• Examining ways to improve NMSS follow-up

of generic communications through the

inspection program.

• Refining the integrated assessment process,

including NMSS efforts to support the Agency

Action Review Meeting and annual reporting to

the Commission on performance trends.

• Refining and reinforcing office-wide guidance

on the proper use of risk information, including

developing program-specific approaches for the

use of risk methods.

• Integrating cross-organizational needs for

explicit specialist skills and broader needs

provided by generalists as part of the Strategic

Workforce Planning initiative.

The Office’s responses to the Davis-Besse Lessons

Learned are being carried out within the context of

“NMSS Values,” with particular focus on our

mission of maintaining adequate levels of safety,

while striving for excellence through continuous

improvement, growth, and learning. The activities

that are being taken will enhance the effectiveness

of internal and external communications, and will

strengthen cooperation among NMSS organizations

by fostering better organizational alignment on

roles, responsibilities, and expectations.

Additional technical information on the Davis-Besse

vessel head cavity can be found on NRC’s website

(www.nrc.gov) under the link, “Davis-Besse/

Reactor Vessel Head Degradation.” The monthly

Davis-Besse NRC Update, which can be accessed

through the News and Correspondence link on this

webpage, describes the current status of NRC and

licensee responses to this event, and it provides a

brief description of its cause.

(Contacts: Michael Markley, NMSS, 301-415-5723,
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e-mail: mtm@nrc.gov; Pat Castleman, NMSS, 301-

415-8118, e-mail: pic@nrc.gov)

PROPOSED RULE TO AMEND

10 CFR PART 35, “MEDICAL USE

OF BYPRODUCT MATERIAL”

The U.S. Nuclear Regulatory Commission (NRC)

seeks public comment on a proposed amendment to

requirements for recognition of specialty board

certifications.

NRC published a proposed rule to amend 10

CFR Part 35 in the Federal Register on December 9,

2003 (68 FR 68549) for a 75-day public comment

period ending on February 23, 2004. The proposed

amendments would revise NRC regulations to

change requirements for recognition of specialty

boards whose certifications may be used to

demonstrate the adequacy of the training and

experience of individuals to serve as radiation safety

officers, authorized medical physicists, authorized

nuclear pharmacists, or authorized users. The

proposed rule would also revise the requirements for

demonstrating the adequacy of training and

experience for pathways other than the board

certification pathway. Interested parties may submit

comments on this proposed rule, as well as a

companion draft Regulatory Analysis, via NRC’s

rulemaking web site at http://ruleforum.llnl.gov.

Further information on the comment process, the

availability of the proposed rule, and related

documents, is available in the Federal Register

notice, containing the proposed rule, referenced

above (68 FR 68549).

(Contact: Roger W. Broseus, NMSS, Mail Stop

T9-C24, U.S. Nuclear Regulatory Commission,

Washington, DC 20555-0001; telephone 301-415-

7608, e-mail: rwb@nrc.gov)

GENERIC COMMUNICATIONS ISSUED

(September 10, 2003 - November 6, 2003)

The following are summaries of U.S. Nuclear

Regulatory Commission (NRC) generic

communications. If one of these documents appears

relevant to your needs and you have not received it,

please call one of the technical contacts listed

below. The Internet address for the NRC library of

generic communications is: http://www.nrc.gov/

reading-rm/doc-collections/gen-comm/index.html.

Please note that this address is case-sensitive and

must be entered exactly as shown. If you have any

questions or comments about generic

communications in general, please contact Ivelisse

M. Cabrera, NMSS, at (301) 415-8152, or by email: imc1@nrc.gov.

Bulletin (BL)

BL 2003-04, “Rebaselining of Data in the Nuclear

Materials Management and Safeguards System,”

was issued on October 8, 2003. This bulletin was

sent to all NRC licensees, Agreement State

licensees, and Certificate Holders (hereafter referred

to as licensees) who have in their possession, or are

licensed to possess, one or more of the following:

foreign obligated natural uranium, depleted

uranium, or thorium; uranium enriched in the

isotope uranium-235, uranium-233, plutonium, or

plutonium-238; or who currently have unreconciled

nuclear material balances with the Nuclear Materials

Management and Safeguards System (NMMSS).

NRC issued this bulletin to:

(i) Notify licensees about performance concerns

associated with their reporting data to, and the

resulting material balances contained in, the

NMMSS database;

(ii) Request affected licensees to perform a one-time

reporting of the quantities of special nuclear

material (SNM) and/or foreign obligated source

material in their possession, specified as:

(a) A quantity of SNM defined by 10 CFR 72.76,

72.78, 74.15, and 150.16, as 1 gram or more of

contained uranium-235, uranium-233, plutonium, or

0.1 gram or more plutonium-238 that is greater than

10 percent of the total plutonium by weight; or (b) A

quantity of foreign obligated source material (i.e.,

natural uranium, depleted uranium, or thorium) defined

by 10 CFR 40.64 and 150.17 as 1 kilogram or more.

(iii) Request affected licensees to perform a onetime reporting of the quantities of other types of

Government-owned materials, specified as any

quantity of deuterium, tritium, curium, americium,

neptunium, californium, berkelium, or enriched

lithium in their possession;

(iv) Request affected licensees to submit the results

of this one-time reporting of the balances of the

requested material types directly to NMMSS, as

described in NUREG/BR - 0006 or 0007 and

NMMSS Report D-24, as referenced in 10 CFR

40.64, 72.76, 72.78, 74.13, 74.15, 150.16, and

150.17, and to coordinate, with NMMSS staff, the

resolution of any discrepancies that become evident,

based on a comparison of the results of the onetime reporting and previously existing licensee

nuclear material balances.

(Technical Contacts: Larry Harris, NSIR, e-mail:

nmmss@nrc.gov; Brian Horn, NSIR, e-mail:

nmmss@nrc.gov)
5

Information Notices (INs)

IN 2003-16, “ Icing Conditions between Bottom of

Dry Storage System and Storage Pad,” was issued

on October 6, 2003. This IN was sent to all 10 CFR

Part 72 licensees and certificate holders to apprise

them of an icing condition at an independent spent

fuel storage installation that placed the dry spent

fuel storage systems into an unanalyzed condition.

(Technical contact: Stephen O’Connor, NMSS, 301-

415-8561, e-mail: sco@nrc.gov)

IN 2003-20, “Derating Whiting Cranes Purchased

before 1980,” was issued on October 22, 2003. This

IN was sent to all holders of operating licenses for

nuclear power reactors, except those who have

permanently ceased operations and have certified

that fuel has been permanently removed from the

reactor vessel, applicable decommissioning reactors,

fuel facilities, and independent spent fuel storage

installations. The purpose of this notice was to

notify licensees of a recent report from Whiting

Corporation concerning the derating of Whiting

cranes sold before 1980.

(Technical contacts: Steven Jones, NRR, 301-415-

2712, e-mail: srj@nrc.gov; Jack Foster, NRR, 301-

415-3647, e-mail: jwf@nrc.gov; William C.

Huffman, NMSS, 301-415-1141, e-mail:

wch@nrc.gov)

Regulatory Issue Summaries (RIS’)

RIS 2003-15, “Consolidation of the Region I and

Region II Materials Program,” was issued on

September 05, 2003. This RIS was issued to all

materials licensees to inform them of the

consolidation of the Region I and Region II

materials programs.

(Technical Contact: George C. Pangburn, RI, 610-

337-5281, e-mail: gcp@nrc.gov)

RIS 2003-16, “NRC Threat Advisory and Protective

Measures System,” was issued on October 7, 2003.

This RIS was sent to:

(1) All NRC power reactor licensees;

(2) All NRC research and test reactors;

(3) All NRC decommissioning power reactors

and independent spent fuel storage

installations using wet storage;

(4) All NRC independent spent fuel storage

installations using dry storage;

(5) All NRC Category I fuel facilities;

(6) All NRC Category III fuel facilities;

(7) The NRC-regulated uranium conversion

facility;

(8) All NRC-regulated gaseous diffusion plants;

and

(9) All NRC power reactor licensees, research

and test reactor licensees, independent spent

fuel storage installation licensees, and special

nuclear material licensees, who possess spent

nuclear fuel; and all general licensees, under

10 CFR 70.20a, who transport spent nuclear

fuel greater than 100 grams.

NRC previously issued guidance regarding the

Homeland Security Advisory System (HSAS) to

certain groups of NRC licensees in RIS’ 2002-12A,

-12B, -12C, -12D, -12E, -12F, -12G, -12H, -12I, -

12I Revision 1, and -12L. NRC is issuing this new

RIS to identify a change in the implementation of

the HSAS for the addressees above who received

RIS’ 2002-12A, -12B, -12C, -12D, -12E, -12F, -

12G, -12H, -12I, and -12I Revision 1. The change

is required by Homeland Security Presidential

Directive -5, “Management of Domestic Incidents,”

dated February 28, 2003.

(Technical contact: Robert J. Stransky, Jr., NSIR,

301-415-6411, e-mail: rjs3@nrc.gov)

RIS 2003-17, “Complying with 10 CFR 35.59,

‘Recentness of Training,’ for Board-Certified

Individuals Whose Training and Experience Were

Completed More Than 7 Years Ago,” was issued on

October 3, 2003. This RIS was sent to all medicaluse licensees and NRC master materials license

medical-use permittees to provide guidance for

licensees and permittees seeking to have individuals

identified as authorized users (AUs), authorized

medical physicists (AMPs), and authorized nuclear

pharmacists (ANPs), under the following

conditions: (1) The individual is certified by a

specialty board recognized by NRC, but the board

certification was received beyond the 7-year time

frame allowed in 10 CFR 35.59; and (2) The

individual is not currently identified on a medicaluse license nor permit as an AU, AMP, or ANP, as

appropriate in 10 CFR 35.13(b)(4).

This RIS: (1) clarifies that for limited-specific, Type

B broad-scope, and Type C broad-scope medicaluse licensees, only NRC, with input from the

Advisory Committee on the Medical uses of

Isotopes, as necessary, may determine what

constitutes adequate “related continuing training and

experience,” for purposes of complying with 10
6

CFR 35.59, “Recentness of Training”; (2) describes

the criteria NRC uses to evaluate “related

continuing training and experience,” under 10 CFR

35.59; (3) describes the information NRC reviews to

make the determination; and (4) describes NRC’s

expectations for Type A broad-scope medical-use

licensees.

(Technical contact: Donna-Beth Howe, Ph.D.,

NMSS, 301-415-7848, e-mail:dbh@nrc.gov)

(General Contact: Ivelisse M. Cabrera, NMSS, 301-

415-8152, e-mail: imc1@nrc.gov)

SIGNIFICANT ENFORCEMENT ACTIONS

The U. S. Nuclear Regulatory Commission’s

(NRC’s) enforcement program can be accessed via

NRC’s homepage at http://www.nrc.gov/ under

“What We Do.” Documents related to cases can be

accessed at http://www.nrc.gov/, “Electronic

Reading Room,” “Documents in ADAMS.”

ADAMS is the Agency-wide Document Access and

Management System. Help in using ADAMS is

available from the NRC Public Document Room,

telephone: 301-415-4737 or 1-800-397-4209.

Gauges

IBS of America (EA-03-079)

On September 15, 2003, a Notice of Violation and

Proposed Imposition of Civil Penalty in the amount

of $7500 was issued for a Severity Level III

problem involving: (1) the failure to verify, before

transfer, that an individual was authorized to receive

licensed material; and (2) the failure to control and

maintain constant surveillance of licensed material

[approximately 370 megabecquerels (MBq) (10

millicuries (mCi)) and 925 MBq (25 mCi) of

americium-241 contained in two sealed sources]

from unauthorized removal or access. Although the

civil penalty would have been fully mitigated, based

on the normal civil penalty assessment process, a

base civil penalty was assessed in accordance with

Section VII.A.1.g of the Enforcement Policy, to

reflect the significance of maintaining control of

licensed material.

G.E. Inspection Services, Inc. (Formerly Liberty

Technologies, Inc.) (EA-03-158)

On October 24, 2003, a Notice of Violation was

issued for a Severity Level III violation involving

the failure to secure from unauthorized removal, or

limit access to, licensed material [approximately 20

gigabecquerels (550 millicuries) of gadolinium-153

contained in a radioactive device] located in an

unrestricted area, and failure to control and maintain

constant surveillance of this licensed material.

Menominee County Road Commission

(EA-03-176)

On October 31, 2003, a Notice of Violation was

issued for a Severity Level III violation involving

the failure to secure from unauthorized removal, or

limit access to, licensed material [nominally 296

megabecquerels (8.0 millicuries (mCi)) of cesium137 and 1.5 gigabecquerels (40 mCi) of americium241:beryllium in a moisture density gauge] in an

unrestricted area at a temporary job site, and failure

to control and maintain constant surveillance of this

licensed material. Specifically, an operator left an

unlocked moisture density gauge unsecured when he

went to his vehicle and did not maintain constant

surveillance of this device.

ABB, Inc. (EA-03-196)

On November 26, 2003, a Notice of Violation and

Proposed Imposition of Civil Penalty in the amount

of $3000 was issued for a Severity Level III

problem involving the failure to secure from

unauthorized removal, or limit access to, licensed

material [approximately 2.9 gigabecquerels (78

millicuries) of strontium-90 in a sealed source

capsule] in an unrestricted area, and failure to

control and maintain constant surveillance of this

licensed material, resulting in the loss of the source

into the public domain (most likely the county

landfill). Although the civil penalty would have

been fully mitigated, based on the normal civil

penalty assessment process, a base civil penalty was

assessed in accordance with Section VII.A.1.g of the

Enforcement Policy, to reflect the significance of

maintaining control of licensed material.

Medical

Caribe Medical Plaza (EA-03-134)

On October 9, 2003, a Notice of Violation was

issued for a willful Severity Level III problem

involving the failure [through its Radiation Safety

Officer (RSO)] to ensure that radiation safety

activities were being performed in accordance with

the radiation safety program; the failure to provide

radiation safety training; the failure to issue film or

Thermoluminescent Dosimeter finger monitors to

appropriate individuals; and the failure of a Caribe

representative to provide information to the

Commission that was complete and accurate in all

material respects. Specifically, the licensee initiated
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brachytherapy procedures without assuring, through

the RSO, that individuals who would be involved in

this activity received appropriate training or proper

dosimetry.

Department of Veteran Affairs, AR (EA-03-162)

On October 31, 2003, a Notice of Violation was

issued for a Severity Level III violation involving

the failure to secure from unauthorized removal, or

limit access to, licensed materials located in the

nuclear medicine department’s hot laboratory,

which is a controlled area, nor did the licensee

control and maintain constant surveillance of this

licensed material. Specifically, the hot laboratory

was left unattended, with a door open, and contained

74 gigabecquerels (GBq) (2 curies) of molybdenum99 in a molybdenum-99/technetium-99m generator;

740 megabecquerels (20 millicuries (mCi)) of

iodine-125 in 52 brachytherapy seeds; and 2.2 GBq

(60 mCi) of cesium-137 in two sources.

Well Logging

Patterson Wireline (EA-03-084)

On September 9, 2003, a Notice of Violation and

Proposed Imposition of Civil Penalty in the amount

of $3000 was issued for a Severity Level III

problem involving the willful failures to: (1) wear

personnel monitoring devices while handling

licensed material; and (2) placard the transport

vehicle used to transport licensed material.

Schlumberger Technology Corporation

(EA-03-010)

On October 14, 2003, a Notice of Violation and

Proposed Imposition of Civil Penalties in the

amount of $90,000 was issued for three Severity

Level III problems involving: (1) the failure to keep

13 public radiation doses within the U.S. Nuclear

Regulatory Commission (NRC) limits ($78,000); (2)

the willful failure to perform radiation surveys, and

failure to maintain control of a radioactive welllogging source ($6000); and (3) the failure to follow

emergency procedures and secure the source after it

was found ($6000). Although the civil penalty

would have been fully mitigated for the first issue,

given the importance that NRC attaches to

protecting members of the public from radiation

exposures, NRC exercised discretion in accordance

with Section VII.A.1 of the Enforcement Policy and

assessed a separate $6000 base civil penalty for each

of the 13 radiation overexposures.

Individual Actions

Daniel Clark Woods (IA-03-038)

On October 24, 2003, a Notice of Violation was

issued for a Severity Level III violation, based on

the individual’s deliberate activities while employed

at G.E. Inspection Services, Inc. (GE-IS)(Formerly

Liberty Technologies, Inc.). As senior radiographer

for the licensee, the individual deliberately failed to

secure from unauthorized removal, or limit access

to, licensed material [approximately 20

gigabecquerels (550 millicuries) of gadolinium-153

contained in a radioactive device] located in an

unrestricted area, and failed to control and maintain

constant surveillance of this licensed material.

Shane Moran (IA-03-006)

On October 14, 2003, a Notice of Violation was

issued for a Severity Level III violation, based on

the individual’s deliberate activities while employed

at Schlumberger Technology Corporation. As a

senior operator on a well logging crew, the

individual knowingly failed to conduct a wellsite

departure survey to ensure that the source was in its

shielded container before the crew left the job site.

Shannon Kokkeler (IA-03-005)

On October 14, 2003, a Notice of Violation was

issued for a Severity Level III violation, based on

the individual’s deliberate activities while employed

at Schlumberger Technology Corporation. As a field

engineer in training on a well logging crew, the

individual knowingly failed to conduct a post-job

survey, to ensure that the source was in its shielded

container before loading the source shield onto the

vehicle.

Patrick L. Patterson (IA-03-023)

On September 9, 2003, a Notice of Violation was

issued for a Severity Level III violation, based on

the individual’s deliberate activities while employed

at Patterson Wireline. As a logging supervisor doing

work in the State of Alaska, he deliberately failed to

wear a personnel dosimeter at all times during the

handling of licensed material and deliberately failed

to placard a transport vehicle used to transport

licensed material.

(Contact: Sally Merchant, 301-415-2747, e-mail:

slm2@nrc.gov)
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SIGNIFICANT EVENTS

Event 1: Dose to Fetus at Community Hospital of

Anderson, Anderson, Indiana

Date and Place: August 8, 2003; Community

Hospital; Anderson, Indiana

Nature and Probable Causes: On August 8, 2003,

Community Hospital of Anderson reported a

misadministration wherein a 35-year old female

patient/physician received an unintentional sodium

iodine-131 (I-131) therapeutic dose of 1.1

gigabecquerels (29.8 millicuries) . At the time of

the therapy, the patient was unaware that she was

pregnant and, as a result, an unintentional dose to

her embryo/fetus was delivered. On August 25,

2003, the patient’s gynecologist informed the

hospital and the patient that she was approximately

15 weeks pregnant at the time of the therapy.

Calculated total body dose to the fetus is 11.69

centigray cGy (rad) and the calculated dose to the

fetal thyroid is 27,840 cGy (rad). NRC and the

licensee’s consulting physicist are in the process of

assessing the doses to the fetus.

The event appeared to be an isolated occurrence.

The root cause of the event was attributed to human

error. Although the authorized physician user and

the chief technologist asked the patient on several

occasions, before the administration of the I-131

dosage, if she were pregnant or believed that she

could possibly be pregnant, the patient denied the

possibility of pregnancy. Because of other preexisting medical conditions and consultations by

other physicians informing the patient that she was

unable to conceive, the patient believed that she

could not become pregnant and declined taking a

pregnancy test before the I-131 therapy. Further,

the hospital staff, knowing that the patient was also

a physician on staff at the hospital, did not pursue a

pregnancy test because they believed that the patient

would be aware of her pregnancy status.

Actions Taken to Prevent Recurrence

Licensee: The licensee reviewed its applicable

procedures and determined that they were

reasonable and appropriate.

Event 2: Misadministration Involving Patient at

Rush Copley Medical Center, Aurora, Illinois

Date and Place: July 28, 2003; Rush Copley

Medical Center; Aurora, Illinois.

Nature and Probable Causes: The licensee reported

that a patient received 0.15 gigabecquerels (GBq)

(4 millicuries (mCi) of iodine-131 (I-131) instead of the

intended 0.15 GBq (4 mCi) of thallium-201 (Tl-201)

for a heart test. Both the exterior lead container and

the syringe were labeled as containing Tl-201. It

was not determined that the patient had been

injected with the wrong radiopharmaceutical until

after the gamma cameras used for patient imaging

were checked a second time on the morning of July

29, 2003. Service engineers were called to the site

to inspect the cameras after two failed attempts to

image the patient. The cause became evident when

the gamma camera flood source, made from what

was thought to be the remaining Tl-201 diagnostic

dose, showed peaks consistent with I-131. The

assayed amount from records showed the dose to be

within the expected range for a typical 0.15 GBq

(4 mCi) Tl-201 diagnostic dose and was considered

normal. The patient was contacted by the referring

physician, onsite oncologists, the hospital

administrator, and a lawyer. The licensee arranged

to perform routine blood analysis throughout the

year to monitor any changes in thyroid activity. The

licensee contacted Medi-Physicis, Incorporated (dba

Amersham Health) in Wood Dale, Illinois, where

the dose had been prepared. The pharmacy indicated

that when prescriptions and labels were taken from

the computer system, the 0.15-GBq (4-mCi) Tl-201

was mistakenly put in with four other prescriptions

for 0.15-GBq (4-mCi) unit doses of I-131. The

pharmacist did not note the difference in nuclides

when the pre-generated Tl-201 label was applied to

the syringe and lead container. The Illinois

Department of Nuclear Safety sent an investigator to

the licensee’s facility on July 30, 2003 to observe

the labeling on the container and syringe, receipt

records, and gamma camera quality assurance tests,

and, to verify by gamma spectrum analysis, the

presence of I-131, as well as to conduct preliminary

interviews. The investigation then moved to the

pharmacy. Based on those visits, the information

obtained largely confirmed the preliminary

notification. The dose to the patient’s thyroid was

calculated to be approximately 5195 centigray (rad).

The patient’s whole body dose is approximately

1587 centisievert (rem). Blood tests suggest that the

patient was hypothyroid as a pre-existing condition.

Actions Taken to Prevent Recurrence

Licensee: Corrective actions taken by the pharmacy

included ceasing the dispensing of I-131 in syringes,

retraining pharmacists, a dual verification system

for all prescriptions received, a triple check system

for dispensing of compounds, and the testing of a

bar code system for all prescriptions.

(Contact: Angela R. Williamson, NMSS, 301-415-

5030; e-mail arw@nrc.gov)
9

SELECTED FEDERAL REGISTER NOTICES

(October 1, 2003 - November 30, 2003)

NOTE: U.S. Nuclear Regulatory Commission

(NRC) contacts may be reached by mail at the U.S.

Nuclear Regulatory Commission, Washington, DC

20555-0001.

FINAL RULES

“Financial Assurance for Materials Licensees,” 68

FR 57327, October 3, 2003. (Contact: James

Morris, NMSS, 301-415-0191, e-mail:

jem2@nrc.gov)

“List of Approved Spent Fuel Storage Casks:

Standardized NUHOMS-24P, -52B, and -61BT

(Revision 6) (Direct final rule)” 68 FR 57785,

October 7, 2003. (Contact: Margaret Stambaugh,

NMSS, 301-415-5449, e-mail: mxs8@nrc.gov)

“Electronic Maintenance and Submission of

Information,” 68 FR 58792, October 10, 2003.

(Contacts: John A. Skoczlas, OCIO, 301-415-7186,

e-mail: eie@nrc.gov; Brenda J. Shelton, OCIO,

301-415-7233, e-mail: infocollects@nrc.gov)

“List of Approved Spent Fuel Storage Casks:

Standardized NUHOMS-24P, -52B, and -61BT

(Revision 5) (Withdrawal of direct final rule),” 68

FR 61734, October 30, 2003. (Contact: Jayne M.

McCausland, NMSS, 301-415-6219, e-mail:

jmm2@nrc.gov)

“Assessment of Access Authorization Fees,” 68 FR

62509, November 5, 2003. (Contact: Patricia A.

Smith, ADM, 301-415-7739, e-mail: pas5@nrc.gov)

PROPOSED RULES

“List of Approved Spent Fuel Storage Casks:

Standardized NUHOMS-24P, -52B, and -61BT

(Revision 6) (Companion proposed rule),”

68 FR 57839, October 7, 2003. (Contact:

Margaret Stambaugh, NMSS, 301-415-5449, e-mail:

mxs8@nrc.gov)

“Licensing Proceeding for the Receipt of HighLevel Radioactive Waste at a Geologic Repository:

Licensing Support Network, Submissions to the

Electronic Docket, 68 FR 66372, November 26,

2003. (Contact: Francis X. Cameron, OGC, 301-

415-1642, e-mail: fxc@nrc.gov)

OTHER NOTICES

“Terrence O. Hee, Ion Technology; Receipt of

Petition for Rulemaking (PRM-40-29),” 68 FR

59346, October 15, 2003. (Contact: Michael T.

Lesar, ADM, e-mail: MTL@nrc.gov)

“Policy Statement on the Treatment of

Environmental Justice Matters in NRC Regulatory

and Licensing Actions (draft),” 68 FR 62642,

November 5, 2003. (Contact: James Lieberman,

OGC, 301-415-2746, fax: 301-415-2036, e-mail:

jxl@nrc.gov)

“Issuance and Availability of Regulatory Guide

3.73, ‘Site Evaluations and Design Earthquake

Ground Motion for Dry Cask Independent Spent

Fuel Storage and Monitored Retrievable Storage

Installations,’” 68 FR 62838, November 6, 2003.

(Contact: M. Shah, 301-415-8537, e-mail:

mjs3@nrc.gov)

“EPA Publication of Advance Notice of Proposed

Rulemaking Regarding the Disposal of LowActivity Radioactive Waste: Request for Comment

(EPA rule published 11/18/03; 68 FR 65120),” 68

FR 64993, November 18, 2003. (Contact: Patricia

Eng, 301-415-7206, e-mail, ple@nrc.gov)

“Approaches to an Integrated Framework for

Management and Disposal of Low-Activity

Radioactive Waste: Request for Comment (EPA),”

68 FR 65120, November 18, 2003.

(Contact: Dan Schultheisz, Radiation Protection

Division, Office of Radiation and Indoor Air,

Mailcode: 6608J, United States Environmental

Protection Agency, Washington, DC, 20460-0001;

telephone (202) 343-9300, e-mail:

schultheisz.daniel@epa.gov)

“Draft U.S. Nuclear Regulatory Commission FY

2004-2009 Strategic Plan, NUREG-1614, Volume 3

(draft),” 68 FR 65968, November 24, 2003.

(Contact: Leslie W. Barnett, OCFO, 301-415-7540)

(General contact: Paul Goldberg, NMSS, 301-415-

7842; e-mail: pfg@nrc.gov)

Comments , and suggestions you may have for

information not currently included, that might

be helpful to licensees, should be sent to:

E. Kraus, Editor

NMSS Licensee Newsletter

Office of Nuclear Material Safety and Safeguards

Two White Flint North, Mail Stop 8-A-23

U.S. Nuclear Regulatory Commission

Washington, D. C. 20555-0001