U.S. Nuclear Office of Nuclear NUREG/BR-0117

Regulatory Material Safety No. 04-04

Commission and Safeguards December 2004

NMSS Quarterly Newsletter

Contents Page

1. Integrated Safety Analysis Reviews –

Moving Towards a More Risk-Informed

Approach to Fuel Cycle Licensing ..................... 1

2. Misconnect Test Added to Maintenance

of Radiography Cameras ................................... 2

3. Tracking of Radioactive Sources ....................... 2

4. Significant Medical Events................................ 3

5. NRC’s Medical Advisory Committee

Meeting for Fall 2004 ........................................ 4

6. Significant Enforcement Actions ....................... 4

7. Selected Federal Register Notices

(September 1, 2004 - November 30, 2004) ........ 5

8. Generic Communications Issued

(September 15, 2004 - December 8, 2004)......... 6

INTEGRATED SAFETY ANALYSIS

REVIEWS -- MOVING TOWARDS a

MORE RISK-INFORMED APPROACH

to FUEL CYCLE LICENSING

The new Subpart H of 10 Code of Federal

Regulations (CFR) Part 70 identifies risk-informed

performance requirements and requires applicants

and existing licensees to conduct an integrated

safety analysis (ISA) and submit an ISA Summary,

as well as other information. In general terms, the

requirements in 10 CFR Part 70 specify the

information that an applicant must supply in its

safety program description. Currently, ISAs are

more qualitative in nature as opposed to a

quantitative approach used in probabilistic risk

assessments prepared for nuclear power reactors.

The decision to use this qualitative approach was

based, in part, on the fact that each of the six fuel

cycle and nuclear materials facilities affected has

unique processes, equipment, and safety features.

Much of the current information and data used in

the accident scenarios is based to a large degree on

the licensees’ expert judgment and in-depth

knowledge of their processes. The ISA approach

has offered unique challenges to both development

and review of these ISAs in an objective and

transparent manner.

Standard Review Plans and Interim Staff Guidance

(ISG) documents have been developed by the NRC

to offer a consistent approach for reviewing the

methods, assumptions and data used in the ISAs.

The primary document, NUREG-1520, “Standard

Review Plan for the Review of a License

Application for a Fuel Cycle Facility,”

complements 10 CFR Part 70 by identifying the

specific information to be submitted by an applicant

and evaluated by the staff. As issues have been

raised and addressed, the NRC has developed draft

ISGs to further guide and document its approach to

these issues. NRC has provided the first eight ISGs

to industry in the summer and fall of 2004. To date,

NRC has received comments on the first six draft

ISGs forwarded. Public comment and NRC review

of these documents are under way. NRC will

incorporate appropriate comments into the final

ISGs or subsequent revisions.

Important issues remain regarding moving ISAs

toward a more risk-informed approach -- namely,

the treatment of dependent failures, human

reliability, the treatment of uncertainty, and the

aggregation or assembly of the scenarios into

overall facility or system measures of risk.

As more issues come to light, the NRC will continue

to revise or augment the ISGs to provide

clarification and support consistency in the reviews

of the ISA summaries. As experience is gained and

consensus developed on the ISGs, NUREG-1520

will be modified to be more risk-informed, and

therefore, more effective and efficient. It is

assumed that now that these initial models have

been developed, and the data requirements are better

defined, a greater amount of objective data will

become available in the future. For example,
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operational and maintenance data from these

systems can be fed back into the models to replace

or validate initial assumptions. Additionally, the

availability of this data will allow the uncertainties

associated with the systems to be better quantified.

In this way, the ISA process will achieve its true

objective: becoming a living document that

accurately reflects the facility processes and hazards

and ensures that those hazards are appropriately

managed and controlled.

(Contacts: James A. Smith, Division of Fuel Cycle

Safety and Safeguards, 301-415-6459;

e-mail: jas4@nrc.gov; and

Wilkins Smith, Division of Fuel Cycle Safety and

Safeguards, 301-415-6459; e-mail: wrs@nrc.gov)

MISCONNECT TEST ADDED to

MAINTENANCE of RADIOGRAPHY

CAMERAS

In response to a recent incident involving a Florida

industrial radiography licensee, AEA Technology

QSA (formerly Amersham) issued a service

bulletin, “Sentinel Service Bulletin September

2004,” to instruct its customers to add performance

of a “Misconnect Test” to the quarterly inspection

and maintenance procedure for the AEA exposure

devices. The misconnect test is designed to detect

long-term wear of the entire locking system.

The test is needed because, even when the wear is

within specifications for the components

individually, a misconnect can occur when slightly

worn components are used together. The Service

Bulletin describes the steps of how to conduct the

test and specifies the conditions when the equipment

must be removed from operation. It must be noted

that misconnect tests must be performed on each

combination of all the devices and all the control

assemblies that are used to detect the combined

effects of wear. The tests should only be performed

by personnel who are formally trained, authorized,

and familiar with the quarterly maintenance

procedures.

AEA Technology started distributing the Service

Bulletin in December 2004, with each of its source

changer shipments and intends to continue such

distributions for about 6 months. The next editions

of the operating manuals will also include the

misconnect test. For further information the contact

at AEA Technology is Ms. Lori Podolak, telephone

(781) 272-2000, ext. 241, e-mail:

Lori.Podolak@aeat-qsa.com.

This article was developed jointly by Walter Cofer,

Bureau of Radiation Control, Florida Dept. of

Health and John Jankovich, Office of Nuclear

Material Safety and Safeguards, NRC.

(Contact: John P. Jankovich, NMSS, 301-415-7904;

e-mail: jpj2@nrc.gov)

TRACKING of RADIOACTIVE SOURCES

The events of September 11, 2001, heightened the

nation’s concerns regarding the use of radioactive

materials for a malevolent act. In June 2002, the

Secretary of Energy and the Chairman of the

Nuclear Regulatory Commission (NRC) met to

address these concerns and discuss the nation’s

ability to adequately protect inventories of nuclear

materials that could be used in a radiological

dispersal device (RDD). An attack involving an

RDD has been of particular concern because of the

widespread use of radioactive materials in the

United States and abroad by industry, hospitals, and

academic institutions. In May 2003, the report

written by the U.S. Department of Energy (DOE)/

NRC Working Group (WG) convened to study these

concerns was accepted by the DOE Secretary and

the NRC Chairman. The WG generated a list of

radionuclides and thresholds for which the tracking

of sources was recommended. A similar study

undertaken by the International Atomic Energy

Agency (IAEA) created a list of radionuclides and

thresholds similar to the DOE/NRC list. The U.S.

Government subsequently committed to using the

IAEA list to support international cooperation on

source tracking.

NRC has started work on a new national system to

track radioactive sources of greatest concern as

designated on the IAEA list. However, since

current regulations do not require reporting source

inventories, NRC and the Agreement States (AS’)

only know the quantities a given licensee has been

authorized to use, not what a licensee has at a given

moment. Thus, the first step, as directed by the

Commission, was the creation of an interim

inventory -- a “snapshot” of the existing sources.

The interim inventory is necessary to provide NRC

and the AS’ with greater detail on the source

population, to plan the development of the source

tracking system.

From October 2003 to September 2004, NRC and

the AS’ contacted over 2600 licensees authorized to

possess quantities of radionuclides which in

aggregate, could exceed the thresholds on the IAEA

list discussed above. This first round of the
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inventory asked for details of the sources, and

additional data such as the number of physical

locations of sources under the license, near-term

disposition plans, and import/export aspects were

subsequently requested. Approximately 99.8

percent of the licensees contacted provided

responses. Each year, until a national source

tracking system is established, NRC and the AS’

will again contact all licensees authorized to possess

quantities of radionuclides which could exceed the

IAEA thresholds and ask for the details of sources

exceeding the thresholds.

The second round of the interim inventory began in

December 2004. Approximately 25 percent of the

licensee population will be contacted each calendar

quarter until a national source tracking system is

established. Although participation in the data

collection is voluntary, licensees are encouraged to

provide the information when requested. Licensees

will be provided the information currently in the

database and requested to update it. Licensees may

update the information either by on-line entry or by

mail. The overall goal is to create a working

tracking system by the end of 2006.

(Contacts: William Ward, Office of Nuclear

Material Safety and Safeguards, 301-415-7038;

e-mail: wrw1@nrc.gov or

Merri Horn, Office of Nuclear Material Safety and

Safeguards, 301-415-8126; e-mail: mlh1@nrc.gov )

SIGNIFICANT MEDICAL EVENTS

Event 1: Dose to Fetus

Date and Place: April 20, 2004; Department of

Veterans Affairs, North Little Rock, Arkansas

The licensee reported an event involving a dose to a

fetus at the Veterans Affairs Medical Center in

Birmingham, Alabama. The patient signed a form

stating that she was not pregnant and a blood sample

was obtained for a serum pregnancy test. However,

when the licensee retrieved the pregnancy test

result, the result from a test performed two months

previously was erroneously retrieved; that test

result was negative for pregnancy. The patient

was then orally administered 0.222 megabecquerel

(6 microcuries) of Iodine-131 sodium iodide on

April 20, 2004. On April 21, 2004, the patient was

intravenously administered 0.444 gigabecquerel

(12 millicuries) of Technetium-99m pertechnetate.

After both dosages were administered, the licensee

discovered that the patient was pregnant. An

ultrasound test was used to determine gestation was

at 9 to 11 weeks. The dose to the fetal thyroid was

estimated to be 6.6 centisieverts (rem) if the thyroid

was functioning, or 0.5 to 1 centisieverts (rem) if the

thyroid was not functioning. The most likely dose to

the fetus and fetal thyroid was estimated at less than

1 centiseivert (rem), based on a fetal age of 10

weeks. The root cause was the failure to follow

procedures and/or inadequate procedures.

Actions Taken to Prevent Recurrence

Corrective actions include retraining nuclear

medicine staff and requiring authorization by the

radiation safety officer before administering any

therapeutic dose to female patients of childbearing

age. In addition, procedures will be modified to

require a staff nuclear medicine physician to

acknowledge pregnancy test results and give

approval in writing.

Event 2: Dose to Wrong Patient

Date and Place: May 10, 2004; University Hospital,

Cincinnati Ohio

The licensee reported that a patient was

administered 74 megabecquerel (2 millicuries) of

Iodine-131(I-131) instead of the prescribed dose

of 7.4 megabecquerel (200 microcuries) of Iodine123(I-123). The patient scheduled to receive the

I-123 dose responded affirmatively to being the

patient that was scheduled to receive the I-131 dose.

The mistake occurred because the technologist did

not follow procedures regarding proper patient

identification. An investigation by the Ohio

Department of Health occurred on May 11-12, 2004.

The licensee’s corrective actions were deemed

adequate.

Actions Taken to Prevent Recurrence

Corrective actions included modification of the

Quality Management Program to delete visual

recognition of patients as a means of patient

identification, and replacing this with verification

via photo identification. Another action included reemphasis of the need to thoroughly check patient

identification using two approved methods.

Event 3: Overdose of Radioiodine

Date and Place: August 10, 2004;

Northeast Alabama Regional Medical Center,

Birmingham, Alabama

The licensee reported that a patient received 111

megabecquerel (3 millicuries) of Iodine-131 (I-131)

for the assessment of metastatic thyroid disease

instead of the prescribed dose of 0.93
4

megabecquerel (25 microcuries). The imaging

technologist misunderstood the referring physician’s

order and the authorized user did not approve the

dose. The referring physician and patient were

notified of the event. As a result of the dose, the

patient could eventually become hypothyroid.

Actions Taken to Prevent Recurrence

Corrective measures included re-instructing

personnel and ensuring that the authorized user

approves all procedures.

(Contact: Angela R. McIntosh, NMSS,

301-415-5030; e-mail: arm@nrc.gov)

NRC’s Medical Advisory Committee

Meeting for Fall 2004

The Advisory Committee on the Medical Uses of

Isotopes (ACMUI) held a public meeting on

October 13-14, 2004, at the Nuclear Regulatory

Commission (NRC) Headquarters in Rockville,

Maryland. The morning session on October 13 was

closed to the public so that NRC staff could provide

the ACMUI with its required annual ethics briefing,

and also discuss other issues not appropriately

discussed in an open, public forum. During the

open, public forum, the agenda items discussed

included such diverse topics as, “ Radiation Safety

Aspects of Iodine-125 Therapeutic Seeds Used as

Markers in Breast Cancer Tumors”; “Update to

Medical Event Criteria Definition”; “Draft Final 10

CFR Part 35 Training & Experience: Status of

Rulemaking; Proposed Changes to the Abnormal

Occurrence Criteria”; and “Radioimmunotherapy

and Microsphere Therapy.”

The agenda items generated much useful discussion

among the ACMUI, the NRC staff, and members of

the public in attendance. In addition to the fruitful

discussions between the ACMUI and the NRC staff,

the ACMUI Chair expressed his appreciation, on

behalf of the members, regarding the improved

relations between the committee and NRC staff, and

thanked NRC management for its efforts in

cultivating a relationship that continues to evolve.

A summary of the October 13-14, 2004 meeting can

be viewed at http://www.nrc.gov/what-we-do/

regulatory/advisory/acmui.html

(Contact: Angela R. McIntosh, 301-415-5030;

e-mail: arm@nrc.gov)

SIGNIFICANT ENFORCEMENT ACTIONS

The NRC’s enforcement program can be accessed

via the U. S. Nuclear Regulatory Commission’s

(NRC’s) homepage [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

Dominion Geotechnical Services, Inc.

(EA-04-165)

On October 14, 2004, a Notice of Violation was

issued for a Severity Level III violation involving

the failure to control and maintain constant

surveillance of licensed material. Specifically,

333 megabecquerel (MBq) (9 millicuries) of

cesium-137, and 1628 MBq (44 millicuries) of

americium-241, contained in a moisture density

gauge that was in an unrestricted area that was not

in storage.

Irradiator

Baxter Healthcare Corporation (EA-04-118)

On October 25, 2004, a Notice of Violation and

Proposed Imposition of Civil Penalty in the amount

of $44,000 was issued for two willful Severity Level

II violations (assessed $28,800 for three occurrences

of failure to adhere to emergency procedures and

$9,600 for failure to perform an adequate survey),

and a willful Severity Level III violation ($6,000 for

failure to provide an individual radiation monitoring

device) related to an event involving personnel

entering an irradiator when the source was stuck in

an unshielded position.

Medical

University of Virginia (EA-04-149)

On October 5, 2004, a Notice of Violation was

issued for a Severity Level III problem involving the

failure to secure licensed material (iridium-192

seeds contained in a nylon ribbon) and the failure to

perform an adequate survey of the patient and the

patient’s room.
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William Beaumont Hospital (EA-04-129)

On September 14, 2004, a Notice of Violation was

issued for a Severity Level III violation involving

the administration of a dosage of liquid iodine-131

to a patient for a thyroid uptake study that was

approximately 90 times larger than the 370

kilobecquerels (10 microcurie) dosage prescribed

by the authorized user physician.

Other

Integrated Production Services (IPS), Inc.

(EA-04-124)

On October 12, 2004, a Notice of Violation and

Proposed Imposition of Civil Penalty in the amount

of $3,000 was issued for a Severity Level III

violation involving the use of byproduct material in

offshore waters without either: (1) following the

reciprocity provisions of 10 CFR Part 150.20, which

would have granted IPS an NRC general license to

conduct activities permitted by its State of Louisiana

license; or (2) obtaining a specific NRC license

authorizing it to conduct licensed activities in

offshore waters.

Soil Consultants, Inc. (EA-04-103)

On October 6, 2004, a Notice of Violation and

Proposed Imposition of Civil Penalty in the amount

of $9,600 was issued for a Severity Level II

violation for discrimination against an employee for

engaging in certain protected activities (reporting

safety concerns to his employer or to the NRC).

(General Contact: Sally Merchant, Office of

Enforcement, 301-415-2747; e-mail: slm2@nrc.gov)

SELECTED FEDERAL REGISTER NOTICES

(September 1, 2004 - November 30, 2004)

“Medical Use of Byproduct Material Minor

Amendments: Extending Expiration Date for

Subpart J,” 69 FR 55736, September 16, 2004.

(Contact: Dr. Anthony N. Tse, Office of Nuclear

Material Safety and Safeguards,

301-415-6233; e-mail: ant@nrc.gov)

“Export and Import of Nuclear Equipment and

Radioactive Materials: Security Policies,”

69 FR 55785, September 16, 2004.

(Contact: Suzanne Schuyler-Hayes, Office of

International Programs, 301-415-2333;

e-mail: ssh@nrc.go)

“Compatibility with IAEA Transportation Safety

Standards (TS-R-1) and Other Transportation

Safety Amendments; Correction,” 69 FR 58038,

September 29, 2004.

(Contact: Mary Adams, Office of Nuclear Material

Safety and Safeguards, 301-415-7249; e-mail:

mta@nrc.gov)

“Criminal History Check: Assessment of

Application Fee,” 69 FR 58820, October 1, 2004.

(Contact: Patricia A. Smith, Security Branch,

Office of Administration, 301-415-7739; e-mail:

pas5@nrc.gov)

“List of Approved Fuel Storage Casks: NAC-MPC

Revision, Confirmation of Effective Date,”

69 FR 61592, October 26, 2004.

(Contact: Jayne M. McCausland, Office of Nuclear

Material Safety and Safeguards, 301-415-6219,

e-mail: jmm2@nrc.gov)

“Adjustment of Civil Penalties for Inflation,”

69 FR 62393, October 26, 2004.

(Contact: Shelly D. Cole, Office of the General

Counsel, 301-415-2549; e-mail: sdc1@nrc.gov)

“Revision of the NRC Enforcement Policy,”

69 FR 62485, 26 October, 2004.

(Contact: Michael T. Lesar, Rules and Directives

Branch, Division of Administrative Services,

Office of Administration, Mail Stop: T6D59;

e-mail comments to: nrcrep@nrc.gov)

Draft Appendix C (DG-1138) to Regulatory Guide

1.200, “An Approach for Determining the Technical

Adequacy of Probabilistic Risk Assessment Results

for Risk-Informed Activities,” Workshop.

69 FR 64115, 3 November, 2004.

(Contact: Mr. A. Singh, Office of Research,

301-415-0250; e-mail: axs3@nrc.gov)

Availability of draft proposed rule language,

10 CFR Parts 2, 30, 40, 50, 52, 63, 70, 72, 73, 76,

and 150, “Protection of Safeguards Information,”

69 FR 67070, 16 November, 2004

(Contacts: Marjorie Rothschild, Division of

Rulemaking and Fuel Cycle, 301-415-1633;

e-mail: mur@nrc.gov or Bernard Stapleton,

Office of Nuclear Security and Incident Response,

301- 415-2432; e-mail: bws2@nrc.gov)
6

(General Contact: Michael K. Williamson,

Office of Nuclear Material Safety and Safeguards,

301-415-6234; e-mail: mkw1@nrc.gov)

GENERIC COMMUNICATIONS ISSUED

(September 16, 2004 - December 8, 2004)

The following are summaries of U.S. Nuclear

Regulatory Commission (NRC) generic

communications issued to NMSS licensees. 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/readingrm/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 e-mail: imc1@nrc.gov .

Bulletins (BLs)

No bulletins have been issued to date.

Information Notices (INs)

IN 2004-12, “Spent Fuel Rod Accountability,”

was issued on June 25, 2004. This IN was sent to

all holders of operating licenses for nuclear power

reactors, research and test reactors, decommissioned

sites storing spent fuel in a pool, and wet spent fuel

storage sites. This notice informed addressees of

issues at two reactor facilities regarding the

effectiveness of the material control and accounting

program.

(Technical Contacts: Todd Jackson, Region I,

610-337-5308; e-mail: tjj@nrc.gov or

Martha Williams, NSIR, 301-415-7878;

e-mail: msw2@nrc.gov)

IN 2004-13, “Registration, Use, and Quality

Assurance Requirements for NRC-Certified

Transportation Packages,” was issued on June 30,

2004. This IN was sent to all materials and

decommissioning reactor licensees to clarify

responsibilities regarding the packaging and

transportation of licensed material, as delineated in

10 CFR Part 71. Specifically, this IN was issued to

remind licensees of 10 CFR 71.12 requirements to

notify NRC before the first use of NRC-approved

transport packages (user registration), and to ensure

licensees have copies of the current Certificates of

Compliance, or other approval, and comply with all

their conditions prior to each transport; and, if

necessary, to properly transfer licensed material

prior to transport, or delivery to a carrier for

transport.

(Technical Contacts: Cynthia Barr, NMSS, 301-

415-4015; e-mail: csb2@nrc.gov or Tomas Herrera,

NMSS, 301-415-7138; e-mail: txh1@nrc.gov)

IN 2004-18, “Recent Safety-Related Event at

Panoramic Wet-Source-Storage Irradiator,” was

issued on October 26, 2004. This IN was sent to all

licensees authorized to possess and use sealed

sources in panoramic wet-source-storage irradiators,

and irradiator vendors to inform them of a recent

safety-related incident at a panoramic wet-sourcestorage irradiator.

(Technical Contacts: Kathy Modes, Region I,

610-337-5251; e-mail: kad@nrc.gov or

Betsy Ullrich, Region I, 610-337-5040;

e-mail: exu@nrc.gov or

Tom Decker, Region I - Atlanta Office,

404-562-4721; e-mail: trd@nrc.gov.)

Regulatory Issue Summaries (RIS’)

RIS 2004-17, “Revised Decay-in-Storage

Provisions for the Storage of Radioactive Waste

Containing Byproduct Material,” was issued on

November 23, 2004. This RIS was sent to all

licensees regulated under 10 CFR Parts 30, 32, 33,

and 50 to inform them of changes to the policy for

authorizing decay-in-storage requirements for

radioactive waste containing byproduct material

with half-lives of less than 120 days.

(Technical Contacts: Angela R. McIntosh, NMSS,

301-415-5030; e-mail: arm@nrc.gov or

Pamela J. Henderson, Region I, 610-337-6952;

e-mail: pjh1@nrc.gov.)

(General Contact: Ivelisse M. Cabrera, NMSS,

301-415-8152; e-mail: imc1@nrc.gov)

Please direct any comments/suggestions for

material in this, and future newsletters to:

Michael K. Williamson

U.S. Nuclear Regulatory Commission

Office of Nuclear Material Safety and

Safeguards

Two White Flint North, Mail Stop T-8F-3

Washington, D.C. 20555-0001