of U.S. Nuclear Office of Nuclear NUREGIBR-0117

OV /v1 ¢ Regulatory Material Safety No. 00-4

*.+° Commission and Safeguards Dec 2000-Jan 2001

IMPLEMENTATION PLAN FOR REVISED

10 CFR PART 35, "MEDICAL USE OF

BYPRODUCT MATERIAL'

The Office of Nuclear Material Safety and

Safeguards (NMSS) is requesting input from

stakeholders on the development of the

implementation plan for the revised 10 CFR

Part 35, "Medical use of byproduct material." The

U.S. Nuclear Regulatory Commission (NRC)

recognizes the need for early participation of our

stakeholders in this process, to achieve a smooth

implementation of the rule. Therefore, we are

seeking input on the following:

1) How can we best communicate the changes

involved in the revised Part 35 with the

organizations that you (the reader) represent?

2) What methods and ideas would be best suited

to communicate revised Part 35 to your

specialty group?

3) Whom, within your organization, should

NRC contact, to arrange presentations, and

discuss ideas to get the message out in an

effective way?

4) What meetings should NRC attend to present

the revised Part 35 and what topics does this

audience want NRC to address?

NMSS staff is currently evaluating: 1) training

sessions for NRC and Agreement State staffs;

2) workshops for licensees and stakeholders;

3) information notices about publication and

implementation of the rule; 4) personal or video

conference presentations to societies and

organizations, like the Conference of Radiation

Control Program Directors, Organization of

Agreement States, and others; and 5) creation of

an NRC Part 35 website. NMSS staff is proposing

that the Part 35 website contain a comparative

table of the old rule versus the new rule,

frequently asked questions, training schedules,

and a section in which stakeholders and licensees

can submit questions, to NRC staff, related to

revised Part 35.

Comments and suggestions can be directed by

mail to: U.S. Nuclear Regulatory Commission,

Mail Stop T8 F5, Attn: Roberto J. Torres,

Washington, DC 20555-0001. Suggestions can also

be sent by electronic mail to Roberto J. Torres, at

rjt@nrc.gov (301-415-8112), and/or Joseph

DeCicco, at jxdl@nrc.gov (301-415-7833).

(Contacts: Roberto J. Torres, 301-415-8112,

e-mail: rjt@nrc.gov; Joseph DeCicco,

301-415-7833, e-mail: jxdl@nrc.gov)

LOST INDUSTRIAL RADIOACTIVE

SOURCE CAUSES TWO DEATHS AND

INJURIES IN EGYPTIAN FAMILY

Disclaimer: This article is based on information

contained in International Atomic Energy Agency

incident response reports and news media reports on

the incident. Although the overall circumstances and

consequences of the event are believed to be correct,

some details of the actual event may be different

than information presented in this article.

In Egypt, a farmer and his son died in June 2000

as a result of radiation exposure received from an

iridium-192 sealed source that was apparently lost

and abandoned by personnel performing

industrial radiography. The farmer, his wife, and

five children lived in the village of Mit Halfa,

located 3040 kilometers (18-25 miles) North of

Cairo, Egypt. In May 2000, the farmer and his

9-year-old son went to a local physician

complaining of burns to the skin. Their physician

diagnosed skin inflammation from some kind of

virus or bacterial infection. The prescribed

medical treatment did not help. In June 2000, the

farmer, who was 60 years old, took his wife, sister

and four children, including the son, to a nearby
NMSS Licensee Newsletter

(Dec. 2000 - Jan 2001)

Contents

Page

1. Implementation Plan for Revised

10 CFR Part 35, "Medical Use of

Byproduct Material" ...................... 1

2. Lost Industrial Radioactive Source

Causes Two Deaths and Injuries in

Egyptian Family ........................ 1

3. The National Materials Program

Working Group ........................ 3

4. NRC Staff Sponsors Decommissioning

Workshop ............................. 4

5. The NMSS Risk Task Group: RiskInformed Regulation in the Materials

and Waste Arenas ......................

6. E-Business Is Here: NRC Prepares to

Accept Electronic Submittals from

Licensees and Vendors ..................

5

5

7. COMPASS-Computer Code for

Implementation of MARSSIM ...... ..... 6

8. Meeting of the Advisory Committee on

the Medical Uses of Isotopes ....... ...... 6

9. Significant Enforcement Actions ...... .... 7

10. Selected Federal Register Notices

(September 1, 2000-September 30,

2000) ............................... 7

11. Generic Communications Issued

(September 1, 2000-November 30,

2000) .............................. 8

12. Significant Events ............. ......... 9

LOST INDUSTRIAL RADIOACTIVE

SOURCE CAUSES TWO DEATHS AND

INJURIES IN EGYPTIAN FAMILY

(continued)

hospital, after the whole family developed skin

discoloration. Within hours after arriving at the

hospital, the farmer's 9-year-old son died. At

some period after the farmer's son died, other

family members, including the farmer, were

admitted to a second hospital in Cairo. Several

days after being admitted to this hospital, the

farmer died.

The deaths of the farmer and his son were linked

to radiation exposure, after a blood test

undergone by the remaining family members

revealed that they had severe depressions in their

white blood cell count. The results prompted

officials to dispatch a radiation monitoring team

to the village where the farmer had lived. The

team performed radiation surveys and found high

radiation levels within the farmer's house. A

radioactive source in a cylinder shape 6.25-

centimeters (cm) (2.5-inches) long and 2.5 cm (1

inch) in diameter was later located. It was

subsequently secured in a shielded container and

removed to a waste disposal site. There was no

evidence that the source was leaking. The source

was later identified as iridium-192, used for

industrial radiography, and having an activity of

1.8 terabecquerel (Thq) [50 curies (Ci)] at the

time it was found.

Information developed during an inquiry into the

event revealed the following circumstances

surrounding the event. The farmer apparently

found the iridium-192 sealed source in a load of

material procured for a home construction

project. He took the radioactive source into his

home. He apparently thought it was valuable. It is

not known how long the farmer had the source in

his home before experiencing symptoms. The

1.8-Thq (50-Ci) iridium-192 source was found to

belong to an industrial maintenance company

performing work in the area. Personnel from the

company were using the iridium-192 source for

industrial radiography work near the village of Mit

Halfa where the farmer and his family lived.

Technicians from the industrial maintenance

company left the cylinder at a site where they

were fixing liquefied gas pipes, believing it was

buried with the pipes. The owner of the consulting

firm failed to notify authorities that the cylinder

had disappeared.

As many as 160 people, neighbors plus relatives

and friends of the farmer, had their white blood

cell counts checked and were evaluated for a need

Comments, and suggestions you may have

for information that is not currently being

included, that might be helpful to licensees,

should be sent to:

E. Kraus

NMSS Licensee Newsletter Editor

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

2
for medical follow-ups. The results of the

evaluations are not known. However, there have

not been more reports of high acute doses of

radiation being received by other persons

associated with this event.

Egyptian officials accused the company personnel

of losing the source, abandoning the source, and

failing to report the loss to competent authorities.

Three men have been arrested and charged

with gross negligence, manslaughter, and

unintentional injury.

The scenario involving the lost radiography

source resembles that of other reported

radiological accidents involving lost sources,

including the loss of a cobalt-60 source at Samut

Prakan near Bangkok, Thailand, February 20,

2000, which resulted in the death of three people.

A similar incident also occurred in Goiania, a

small town in central Brazil. In that incident,

scavengers pried open a metal canister from a

radiation therapy (teletherapy) machine

abandoned by a cancer treatment clinic. The

machine contained 51.8 Tbq (1400 Ci) of

cesium-137. Four people died as a result of the

incident; 244 people were contaminated.

Events of this type underscore the severe

consequences that can result from the loss of

radioactive material in the public domain and the

failure to report the loss to competent authorities

so that actions can be taken to find the source and

warn the public. To prevent losses of the type that

led to the exposures in Egypt, proper radiation

surveys must be done to ensure that radiation

sources are properly stored and contained, on

completion of work.

Although there have been several incidents

reported in the U.S. involving the loss of a

radioactive source in circumstances similar to the

Egyptian event, personnel radiation exposures of

the type that occurred in the Egyptian event

fortunately have been avoided.

(Contact: Sam Pettijohn, 301-415-6822; e-mail:

slp@nrc.gov)

THE NATIONAL MATERIALS PROGRAM

WORKING GROUP

Agreement States currently regulate 75 percent of

the nuclear materials licensees in the U.S., and

have the potential of regulating 80 percent of U.S.

licensees by fiscal year 2003 when three more

Agreement States are expected to be in place. On

November 23, 1999, the Commissioners of the

Nuclear Regulatory Commission (NRC) requested

the creation of a National Materials Program

(NMP) Working Group (WG) through a Staff

Requirements Memorandum (SECY 99-250). The

purpose of the WG is to provide the Commission

with options for maintaining an infrastructure of

supporting regulations, guidance and other

program elements needed for the nationwide

materials program, considering the anticipated

increase in the number of Agreement States. Part

of the purpose of this group is to look at the future

of radiation protection programs and define what

a "national materials program" should look like

and how it should work.

The NMP WG consists of representatives from

NRC Headquarters and regions; the Organization

of Agreement States (OAS); and the Conference

of Radiation Control Program Directors

(CRCPD). There are 12 members on the WG and

one NRC management advisor. In addition, a

steering committee consisting of senior NRC

management and one representative each from

OAS and CRCPD was created in January 2000.

This WG began meeting in the winter of 2000.

Rather than dictating a top-down structure, the

WG decided to take a bottom-up approach, to

develop a good foundation before designing an

organizational structure.

The WG began by identifying the key elements of

a radiation protection program based on CRCPD

publications and those concepts used in NRC's

Integrated Material Performance Evaluation

Program (IMPEP) (e.g., licensing, inspection,

guidance development, regulation development,

etc.). Then the WG identified the current methods

of accomplishing those program elements, in

addition to brain-storming new options for

meeting the program needs. The options

developed were then evaluated against the current

method of accomplishing the objective, using the

following criteria:

* Does the option optimize resources of

Federal, State, professional, and industrial

organizations?

* Does the option account for individual agency

needs and abilities?

* Does the option promote consensus on

regulatory priorities?

* Does the option harmonize regulatory

approaches?

* Does the option recognize State and Federal

needs for flexibility?

3
On further review, the WG found that the most

efficient and effective options shared certain

common attributes:

- They used a consensus process.

- They recognized successes.

- They maintained flexibility.

- They shared resources.

- They made use of alternative resources.

- They increased communications and

decreased duplication.

- They recognized shared responsibility.

By August 2000, the program's goals were clearly

defined. The next question facing the WG was

how to use the common attributes to design and

build a supporting structure. The WG evaluated

several types of interagency relationships to find

successful mechanisms that could meet all of the

attributes and goals. Several ideas have been

considered: there could be numerous autonomous organizations in the national materials

program, the consultive process presently used

could be retained, an advisory committee could be

an option, or, a consensus mechanism similar to

an alliance could be developed.

At the OAS meeting October 2-4, 2000, NRC and

the Agreement States participated in a tabletop

exercise designed to test methods for arriving at

concurrence on what issues are "national"

priorities. There was a lot of discussion about

establishing priorities, determining resources

available to address the issues, and the whole

"alliance" concept. The WG has evaluated the

comments received during that exercise and is

incorporating them into the final product.

The WG needs more information from

stakeholders and the public as it continues to

develop options related to the structure, function,

and implementation of a national materials

program. To further this initiative, the WG will be

holding a stakeholders' meeting at NRC's Region

IV Office, Arlington, Texas, on February 21-22,

2001. Information on the WG's meeting and other

information, such as the charter, list of members,

and notes or outlines of proposals can be found on

the web at the following URL: www.hsrd.oml.gov/

nrc/home.html. Additional information about the

national materials program may be found in the

November 2000 issue of The Health Physics

Society's Newsletter, or you may contact the WG

Co-Chairs, Jim Myers, at 301-415-2328, e-mail:

jhm@nrc.gov, or Kathy Allen, at 217-785-9931,

e-mail: or k allen(idns.state.il.us.

(Contact: Jim Myers, 301-415-2328, email:

ghm(nrc.gov)

NRC STAFF SPONSORS

DECOMMISSIONING WORKSHOP

On November 8 and 9, 2000, U.S. Nuclear

Regulatory Commission (NRC) staff sponsored a

workshop at NRC's Headquarters in Rockville,

MD. The purpose of the workshop was to provide

a forum for industry and non-industry

stakeholders to discuss NRC's processes and

procedures for managing the decommissioning of

nuclear facilities, as well as current issues facing

the staff and licensees as they implement NRC's

decommissioning requirements with NRC staff.

The theme of the workshop was "Inform, Listen,

Learn." To promote this theme, the staff first

made presentations on NRC's decommissioning

requirements and processes for both material and

reactor facilities and on NRC staff expectations

for license termination plans and decommissioning plans. Presentations were followed by a series

of facilitated, roundtable discussions on the

decommissioning process, and current issues in

decommissioning, such as releasing portions of

sites before license termination, and requirements for institutional controls for sites

contemplating license termination with

restrictions on future site use.

To ensure that both industry and non-industry

stakeholders were represented at the workshop,

staff invited representatives from the nuclear

industry, various public interest groups, and other

Federal and State agencies with responsibilities

for regulating the use of radioactive material to

participate in the roundtable discussions.

Approximately 130 individuals representing the

nuclear industry, citizens' organizations and the

public, Federal and State regulatory agencies, and

the media, attended the workshop.

Based on the discussions at the workshop, it

appears that although the NRC staff has made

progress in developing and implementing the

decommissioning program, some members of the

public are concerned about the timing of the

submission of the License Termination Plan for

power reactors undergoing decommissioning; the

appropriateness of a general license for a dry cask

storage area; and, the closure of NRC's local

Public Document Rooms.

NRC staff is currently developing a summary of

the workshop as well as a set of recommendations

that will be forwarded to the Commission for its

4
consideration. Transcripts of the meeting and

material used by the NRC staff during presentations will be posted at: http://www.nrc.gov/

NMSS/DWM/DECOM/decomm.htm as soon as

they are available.

(Contact: Dominick A. Orlando, 301-415-6749,

e-mail: dao@nrc.gov)

THE NMSS RISK TASK GROUP:

RISK-INFORMED REGULATION IN THE

MATERIALS AND WASTE ARENAS

The Risk Task Group (RTG) was created to

develop the best approach for incorporation of

risk information into the regulation of nuclear

materials and disposal of radioactive waste.

Currently, the task group reports to the Office of

the Director, office of Nuclear Material Safety

and Safeguards (NMSS). As the focal point for

NMSS risk-informed initiatives and activities,

RTG will identify and support new regulatory

initiatives that use risk assessments and risk

insights to add value to the NMSS decisionmaking process. Additionally RTG will review new

regulatory applications, and technical products to

ensure consistent and appropriate application of

risk methodology, and to ensure that any change

to our existing regulatory position is consistent

with the risk significance. Further details can be

found in SECY-99-100, "Framework for

Risk-Informed Regulation in the Office of

Nuclear Material Safety and Safeguards."

One of RTG's first undertakings for fiscal year

2001 will be a series of case studies in the material

and waste arenas. The objectives of the case

studies will be to: (1) illustrate what has been

done, and what could be done, in the materials

and waste arenas, to alter the regulatory approach

in a risk-informed manner; and (2) establish a

framework for using a risk-informed approach by

testing the draft screening criteria, and

determining the feasibility of safety goals for the

material and waste arenas. The intent of the case

studies is not to reopen or reassess previous

decisions made by the staff and the Commission.

However, the information gained by performing

the case studies may impact future decisions.

Individual case study areas include: fixed gauges;

gas chromatographs; static eliminators; site

decommissioning; uranium recovery facilities;

radioactive material transportation; 10 CFR

Part 76; and spent fuel interim storage. Each case

study will be of limited scope, but collectively the

case studies will cover a broad spectrum of

regulatory applications. When the case studies

are completed, the results will be presented to

the Commission.

RTG is also involved in developing and

implementing training classes designed to increase

familiarity with risk assessment techniques in

NMSS. The first class, "Introduction to Risk

Assessment in NMSS," will be offered periodically

throughout the year. RTG will also lend support to

Division activities related to risk information.

Additionally, in support of the Agency's effort to

incorporate consensus standards and international

guidance into our regulatory framework, a

member of RTG serves as the U.S. representative

of the International Atomic Energy Agency's

Technical Committee on Standards for Use of

Probabilistic Safety Assessment in Non-Reactor

Nuclear Facilities.

(Contact: Raeann. M. Shane, 301-415-7832,

e-mail: rms2@nrc.gov)

E-BUSINESS IS HERE: NRC PREPARES

TO ACCEPT ELECTRONIC SUBMITTALS

FROM LICENSEES AND VENDORS

As part of the Nuclear Regulatory Commission's

(NRC's) is continuing efforts to enhance

electronic business processes, the Agency is

developing a rulemaking to allow all individuals

and organizations sending information to NRC to

do so electronically, either through the Electronic

Information Exchange (EIE) process at the

Agency EIE Website (http://www.nrc.gov/

NRC/EIE/index.html) or by mailing CD-ROM

versions of their documents to NRC. The

rulemaking will be comprehensive and address all

10 CFR Parts, including all holders of materials

licenses. This rulemaking is anticipated in

calendar year 2001.

In advance of the rulemaking, the Office of the

Chief Information Officer (OCIO) is renewing an

EIE pilot project for two NRC organizations-the

Atomic Safety Licensing Board Panel (ASLBP)

and the Office of the Secretary (SECY)-to test

the submission and processing of documents sent

to destinations other than the Document

Processing Center (DPC). Traditionally, hearing

documents have been submitted directly to SECY

or ASLBP. ASLBP was part of the initial pilot

until legal questions about digital signatures

caused some of the participants to stop sending

documents electronically. Recent legislation has

clarified the use of digital signatures and the pilot

will be restarted.

Most of the voluminous boxes of paper and

three-ring binders from reactor licensees and

vendors arriving at the loading dock of NRC

5
offices at One White Flint North are becoming a

thing of the past. That's when NRC will permit

reactor licensees and vendors licensed under

10 CFR Part 50 to submit documents to the

Agency electronically, instead of in paper form.

NRC's OCIO will notify the Agency by a Network

Announcement when the electronic submittals

officially begin.

These developments are the culmination of a

process that began with a year-long pilot program

between the Agency and licensees, for three

nuclear power plants to work out technical and

procedural bugs. The pilot recently ended

successfully. Licensees participating in the EIE

process first obtain digital certificates from NRC to

submit their information via EIE over the

Internet. The digital certificates provide the

security that allows electronic documents to be

digitally signed before submission. All documents

sent in electronic format, whether via EIE or on a

CD-ROM, are received by OCIO's DPC staff, for

profiling and entry into NRC's Agencywide

Documents Access and Management System. The

DPC staff then electronically distributes them

throughout the Agency, through the Electronic

Regulatory Information Distribution System. One

nice feature of the EIE system is that licensees

and vendors submitting documents will be

notified, via e-mail, of the time and date that NRC

received the documents. Presently, unless

documents are sent "Receipt Requested,"

licensees cannot verify that NRC received their

packages until days later.

At this time, only documents submitted to NRC

may be sent in electronic form; documents leaving

the Agency cannot be sent electronically. The

OCIO is exploring the requirements for a system

that would permit the staff to electronically

dispatch documents to Agency clients.

Additional information on either the Rulemaking

or the EIE process may be obtained by contacting

John Skoczlas at 301-415-7186.

(Contact: John Skoczlas, 301-415-7186, e-mail:

jasl@nrc.gov)

COMPASS-COMPUTER CODE FOR

IMPLEMENTATION OF MARSSIM

The Computerization Of the Multi-Agency

Radiation Survey and Site Investigation Manual

(MARSSIM) for Planning and Assessing Site

Eurveys (COMPASS) computer code is a tool for

facilitating statistical calculations in planning of

final status surveys, using the guidance in

MARSSIM (NUREG-1575). COMPASS was

developed by the Oak Ridge Institute for Science

and Education-Environmental Survey and Site

Assessment Program, with sponsorship of the U.S.

Nuclear Regulatory Commission (NRC). The code

is written in Visual Basic and runs on Windows

and NT platforms.

COMPASS provides computerization of the

MARSSIM survey and investigation process and

includes functions to: (1) design surveys with

multiple contaminants using the unity rule; (2)

perform calculations of the modified derived

concentration guideline levels (DCGLs) using the

surrogate approach, gross-activity DCGLs using

relative fractions, and the number of

measurements and samples needed by the

nonparametric statistical tests and the elevated

measurement comparison test; (3) generate

prospective and retrospective power curves to

demonstrate the attributes of each MARSSIM

survey unit design; and (4) determine whether

residual radioactivity levels meet the release

criteria, using a statistically based decision rule.

Benefits of COMPASS include performing

multiple analyses quickly with reduced calculation

error, efficiently developing and implementing an

effective survey design, and providing consistency

of information.

NRC intends to issue the code as freeware.

COMPASS Beta version 0.9.1 was issued by

NRC, as a download, for testing and evaluation

by interested users on November 21, 2000, from

NRC's Nuclear Facilities Decommissioning web

site under "Special Projects" at: http://

www.nrc.gov/NMSS/DWM/DECOM/

decomm.htm.

Testing of the Beta code will end on December 22,

2000. Comments on testing of COMPASS Beta

code version 0.9.1 should be forwarded to

Dr. Richard Clement (Office of Nuclear Material

Safety and Safeguards/Division of Waste

Management/Decommissioning Branch).

(Contact: Dr. Richard Clement, 301415-6625,

e-mail: rscl@nrc.gov)

MEETING OF THE ADVISORY

COMMITTEE ON THE MEDICAL USES OF

ISOTOPES

The U.S. Nuclear Regulatory Commission's

(NRC's) Advisory Committee on the Medical

Uses of Isotopes (ACMUI) held a meeting on

November 8-9, 2000. The topics of discussion

included: 1) status and implementation of the

10 CFR Part 35 rulemaking; 2) NRC initiatives:

risk-informed and performance-based regulation;

6
3) intravascular brachytherapy and new radiation

technology issues; 4) NRC lessons learned from

Mallinckrodt exposure events; 5) NRC/Agreement

State working group on event reporting; 6) update

of other rulemaking activities; and 7) selfevaluation criteria for the ACMUI. Five new

members, representing various specialities such

as radiation oncology, nuclear pharmacy, therapy,

medical physics, and radiation safety, began

serving 3-year terms on the ACMUI.

Copies of the transcript and summary minutes for

the meeting are available through the NRC Public

Document Room (301-415-4737). The next

meeting of the ACMUI will be noticed in the

Federal Register.

(Contact: Betty Ann Torres, 301-415-0191, e-mail:

bat@nrc.gov)

SIGNIFICANT ENFORCEMENT ACTIONS

Detailed information about these enforcement

actions can be accessed via the U. S. Nuclear

Regulatory Commission's (NRC's) homepage

[http://www.nrc.gov/OE/]. Click on "Enforcement

Actions." Cases are listed alphabetically. To access

the complete enforcement action, click on the

highlighted text after the name of the case.

MEDICAL

John M. Corboy, M.D., Wahiawa, HI EA-00-059.

A Notice of Violation and Exercise of

Enforcement Discretion was issued for a Severity

Level II violation on July 25, 2000. The action was

based on the failure of the licensee to account for

radioactive decay of strontium-90 used in eye

applicators. As a result, the incorrect source

strength was used to determine treatment times,

resulting in 71 misadministrations. A civil penalty

was not proposed because the licensee voluntarily

suspended use of the eye applicators, transferred

the applicators, and requested termination of

the license.

Roberto Buxeda-Dacri, M.D., Santurce, PR

EA-00-141. A Notice of Violation and Proposed

Imposition of Civil Penalty in the amount of $2750

was issued July 14, 2000. The action was based on

a violation involving the failure to test an eye

applicator source, containing approximately 1147

megabequerels (31 millicuries) of Strontium-90,

for leakage at proper intervals.

VA Medical Center, Philadelphia, PA EA-00-086.

A Notice of Violation and Proposed Imposition of

Civil Penalty in the amount of $5500 was issued

July 19, 2000. The action was based on a violation

involving the failure to comply with the

requirements of 10 CFR 50.7, "Employee

protection." The Merit Systems Protection Board

substantiated that VA Medical Center,

Philadelphia, had retaliated against a former

research nurse, for whistle-blowing activity, when

the individual was subjected to intolerable

working conditions, and that this environment was

created as a result of her raising safety issues.

OTHER

Spectrum Pharmacy, Inc., Mishawvaka, IN

EA-00-071. A Notice of Violation and Proposed

Imposition of Civil Penalty in the amount of $2750

was issued September 21, 2000. The action was

based on the licensee's failure to ship radioactive

material packages in accordance with NRC and

Department of Transportation requirements, its

failure to follow its emergency plan in response to

a spill of radioactive material, and its failure to

perform adequate surveys subsequent to the spill

of radioactive material.

RADIOGRAPHY

Braun Intertec Corporation, Minneapolis, MN

EA-00-147. A Notice of Violation and Proposed

Imposition of Civil Penalty in the amount of $5500

was issued August 14, 2000. The action was based

on a violation involving the willful failure to have

two individuals present during radiography at a

temporary job site.

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

slm2@nrc.gov)

SELECTED FEDERAL REGISTER NOTICES

(September 1, 2000-September 30, 2000)

NOTE: U.S. Nuclear Regulatory Commission

(NRC) contacts may be reached by mail at the

U.S. Nuclear Regulatory Commission,

Washington, DC 20555-0001. Only non-NMSS

Office personnel will be identified by Office, in

"Contact(s)," below.

FINAL RULES

"Licensing of Special Nuclear Material;

Possession of a Critical Mass of Special Nuclear

Material," 65 FR 56211, September 18, 2000.

Contacts: Theodore S. Sherr, 301415-7218,

e-mail: tss@nrc.gov.

Heather Astwood, 301415-5819, e-mail:

hma@nrc.gov.

Andrew Persinko, 301-415-6522, e-mail:

axpl@nrc.gov.

7
OTHER NOTICES

"Relocation of the Nuclear Regulatory

Commission's Public Document Room

(completed September 26, 2000)," 65 FR 54865,

September, 11, 2000.

Contact: Thomas Smith, OCIO, 301-415-7204,

e-mail : tes@nrc.gov.

"Staff Meetings Open to the Public: Final Policy

Statement," 65 FR 56964, September 20, 2000.

Contact: Rosetta 0. Virgilio, OEDO,

301-415-2307, e-mail: rov@nrc.gov.

(General Contact: Paul Goldberg, 301-415-7842,

e-mail: pfg@nrc.gov)

GENERIC COMMUNICATIONS ISSUED

(September 1, 2000-November 30, 2000)

Note that these are only 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

www.nrc.gov/NRC/GENACT/GC/index.html.

Please note that this address is case-sensitive and

must be entered exactly as shown.

Information Notices (INs)

IN 2000-12, "Potential Degradation of Firefighter

Primary Protective Garments" was issued on

September 21, 2000. This notice was issued to all

holders of licenses for nuclear power, research,

and test reactors, and fuel cycle facilities, to

alert addressees to potential degradation of

performance of firefighter primary protective

garments (FFPPGs). Licensees were reminded

that proper storage and regular thorough

inspections of FFPPGs are important to ensure

that these garments provide effective firefighter

protection because their degradation may not be

readily apparent.

Contacts: Christopher G. Cahill, Region I,

610-337-6916, e-mail: cgc@nrc.gov.

Paul W. Lain, NMSS, 301-415-6317,

e-mail: pwlinrc.gov.

Daniel M. Frumkin, NRR,

301-415-2280, e-mail: dxfl@nrc.gov.

Charles D. Petrone, NRR,

301-415-1027, e-mail: cdp@nrc.gov.

Mark H. Salley, NRR, 301-415-2840,

e-mail: mxs3@nrc.gov.

IN 2000-15, "Recent Events Resulting in

Whole-Body Exposures Exceeding Regulatory

Limits" was issued on September 29, 2000. This

notice was issued to all radiography licensees to

alert addressees to recent events that resulted in

radiographers receiving occupational whole body

doses in excess of the 0.05-sievert (5-rem) total

effective dose equivalent limit specified in 10 CFR

20.1201(a)(1).

Contact: Linda M. Psyk, NMSS, 301-415-0215,

e-mail: lmpl@nrc.gov.

IN 2000-16, "Potential Hazards due to

Volatilization of Radionuclides " was issued on

October 5, 2000. This notice was issued to all NRC

licensees that process unsealed byproduct material

to alert addressees to the potential hazards

associated with the volatilization of

radiochemicals and/or radiopharmaceuticals if

containment is breached during chemical or

physical processing.

Contact: Kevin G. Null, Region III, 630-829-9854,

e-mail: kgn@nrc.gov.

IN 2000-18, "Substandard Material Supplied by

Chicago Bullet Proof Systems" was issued on

November 29, 2000. This notice was issued to all

10 CFR Part 50 licensees and applicants, all

category I fuel facilities, and all 10 CFR Part 72

licensees and applicants, to inform addressees of

substandard material supplied by Chicago Bullet

Proof Systems (CBPS) to Fort St. Vrain and

Susquehanna nuclear power plants. CBPS

supplied material that was not in conformance

with specifications of the licensees' purchase

orders and not in conformance with NRC

guidance documents (e.g., NUREG-0908).

Contacts: Joseph Petrosino, NRR, 301-415-2979,

e-mail: jjpl@nrc.gov.

Michael Warren, NMSS, 301-415-8098,

e-mail: msw@nrc.gov.

Eric Benner, NRR, 301-415-1171,

e-mail: ejbl@nrc.gov.

Robert Skelton, NRR, 301-415-3309,

e-mail: rfsl@nrc.gov.

Regulatory Issue Summaries (RIS')

RIS 2000-18, "Guidance on Managing Quality

Assurance Records in Electronic Media" was

issued on October 23, 2000. This summary was

issued to all holders of operating licenses for

nuclear power plants, including licensees that have

permanently ceased operations and have certified

that fuel has been permanently removed from the

reactor vessels. This summary was also issued to

those materials licensees, including certificate

holders and vendors, that are required to have

NRC-approved quality assurance programs, to

8
provide updated guidance on managing quality

assurance records in electronic media.

Contacts: Michael T. Bugg, NRR, 301-415-3221,

e-mail: mtb~nrc.gov.

James J. Pearson, NMSS, 301-415-1985,

e-mail: jjp@nrc.gov.

Mark A. Sitek, NMSS, 301-415-5799,

e-mail: mas3@nrc.gov.

RIS 2000-23, "Recent Changes to Uranium

Recovery Policy," was issued on November 30,

2000. This summary was issued to all holders of

materials licenses for uranium and thorium

recovery facilities, to inform addressees of the

Commission's decisions on four Commission

Papers prepared by the Uranium Recovery staff

and the Office of the General Counsel. All of the

policy decisions will be codified in the new

10 CFR Part 41.

Contact: Kenneth R. Hooks, NMSS,

301-415-7777, e-mail: krhlnrc.gov.

(General Contact: Mark A. Sitek, NMSS,

301-415-5799; e-mail: mas3@nrc.gov)

SIGNIFICANT EVENTS

The U.S. Nuclear Regulatory Commission (NRC)

is providing summaries of these events to inform

licensees of conditions they may encounter and of

actions that may be taken to deal with them.

Event 1: Misadministration involving an

iodine-125 (I-125) permanent implant at

Cumberland Medical Center, Crossville,

Tennessee

Date and Place: August 14, 2000; Cumberland

Medical Center, Crossville, Tennessee.

Nature and Probable Consequences: The licensee

reported a therapeutic misadministration

involving two patients being treated for prostate

cancer with 1-125 seed implants. The

pre-treatment plan for patient No. 1 called for 78

seeds containing 12.06 megabecquerel (MBq)

[0.326 millicurie (mCi)] per seed. The

pre-treatment plan for patient No. 2 called for 123

seeds containing 8.47 MBq (0.229 mCi) per seed.

During the post-plan review, it was discovered

that an error had occurred when ordering the

seeds. Patient No. 1 was treated with seeds

containing 15.32 MBq (0.414 mCi) per seed and

patient No. 2 was treated with seeds containing

10.77 MBq (0.291 mCi) per seed. Follow-up

information indicates that only one patient

received a reportable misadministration dose. The

pre-treatment plan for patient No. 1 called for a

dose of 10,800 to 11,000 centiGray (cGy) (10,800

to 11,000 rads) and the calculated dose was

determined to be 13,000 to 13,500 cGy (13,000 to

13,500 rads), which exceeded the prescribed dose

by approximately 23 percent. The dosage to

patient No. 2 was calculated to have exceeded the

prescribed dosage by approximately 17 percent.

Both patients are being monitored for adverse

reactions. The incident was caused by human

error. The wrong seed activity was ordered from

the source supplier, which resulted in the patients

receiving more activity than was prescribed.

Actions Taken to Prevent Recurrence

Licensee: The licensee's corrective actions to

prevent recurrence will include independent

checks on the isotope type, activity, and

number of seeds to be implanted. These

checks will be performed by the radiation

oncologist, the medical physicist, and the medical

dosimetrist, before ordering, and again before

patient implantation.

State Agency: The Tennessee Division of

Radiological Health conducted interviews with

licensee personnel and the medical physicist on

August 31, 2000, to verify the circumstances of the

event and the corrective actions taken by the

licensee to prevent a recurrence.

Event 2: Misadministration involving the use of

Yttrium-90 (Y-90) microspheres at the University

of Pittsburgh's Presbyterian Hospital, Pittsburgh,

Pennsylvania

Date and Place: August 15, 2000; University of

Pittsburgh, Pittsburgh, Pennsylvania

Nature and Probable Consequences: On August 15,

2000, the licensee reported a possible

misadministration, involving a patient undergoing

treatment for liver cancer, using 2.96

gigabecquerels (80 millicuries) of Y-90

microspheres. The microspheres are

manufactured and distributed by MDS Nordion

under the product name TheraSphere.

TheraSphere is administered to patients under a

Humanitarian Device Exemption (HDE) issued

by the Food and Drug Administration (FDA).

TheraSphere is supplied with an administration

set that facilitates the transfer of the microspheres

from the product vial through an arterial catheter,

which is inserted in the hepatic artery, and into

the patient's liver. Before the treatment,

technetium-99m labeled macroaggregated

albumin (Tc-99m MAA), which mimics the

transport of the microspheres through the hepatic

artery and liver, was injected into the arterial

catheter to verify that the microspheres would be

9
trapped in the vasculature of the liver and not

travel to other areas of the body. A scan of the

patient revealed that the Tc-99m MAA remained

in the liver as required. During the subsequent

administration of the TheraSphere, everything

appeared to go well; however, surveys of the

patient and the administration set showed that a

significant quantity of the microspheres remained

in the administration set and the arterial catheter.

The University of Pittsburgh and MDS Nordion

initiated an investigation and concluded that

approximately 65 percent of the intended dose

was administered to the patient. The University of

Pittsburgh submitted a report of misadministration on September 12, 2000. Further

investigation revealed that there was a significant

problem with the design of the administration set,

which resulted in the incomplete administration of

the TheraSphere dose. MDS Nordion continues to

evaluate the problem with the administration set.

The FDA is aware of the problem and is working

with MDS Nordion to amend the HDE. The

University of Pittsburgh and MDS Nordion

concluded that TheraSphere could be reliably

administered to patients, using a larger volume of

sterile, pyrogen-free water to transfer the

microspheres in conjunction with careful surveys

of the administration set during the

administration. No one was contaminated or

overexposed during this event.

Actions Taken to Prevent Recurrence

Licensee: The University of Pittsburgh postponed

subsequent treatments pending the result of an

investigation into the cause of this incident. The

University of Pittsburgh worked with MDS

Nordion to identify the cause of the administration. Patient treatments were resumed once it

was determined that TheraSphere could be

reliably administered using a larger volume of

sterile, pyrogen-free water to transfer the microspheres, in conjunction with careful surveys of the

administration set during the administration.

NRC: The State of Maryland was immediately

notified of the event because NRC was aware that

a Maryland licensee was intending to perform a

TheraSphere treatment on August 16, 2000. NRC

Region 1 and the Office of Nuclear Material

Safety and Safeguards evaluated the

circumstances leading to this event and are

monitoring MDS Nordion's efforts, along with

FDA, to redesign the administration set.

Event 3: High-Dose-Rate Remote Afterloader

Misadministration at the University of Virginia,

Charlottesville, Virginia

Date and Place: September 7, 2000; University of

Virginia; Charlottesville, Virginia.

Nature and Probable Consequences: On

September 13, 2000, the licensee notified the NRC

Operations Center of a medical misadministration

that occurred on September 7, 2000, regarding a

patient who had undergone a high-dose-rate

brachytherapy treatment (HDR treatment) for

cervical cancer. The treatment was performed

using a GammaMed HDR, Model No. 12i, and a

tandem and ovoid applicator. The treatment plan

was to give the patient a prescribed dose of 5 gray

(Gy) [500 rads] in one single fraction. Instead, the

patient received an unintended dose of 8 Gy (800

rads). The licensee discovered the error during a

review of the patient's treatment plan late that

same day.

The licensee investigated and determined that the

radiation sources remained in the patient at the

wrong locations because the positions in the

treatment plan had been entered in the reverse

order and the medical staff did not detect this

error. From a review of the treatment and dose

administered, the attending physician had

determined that the patient would have no

adverse effects from the unintended dose.

The cause of the event was operator error during

the digitization of film data. In addition, the

established second-check procedures were

inadequate to detect the error. A contributory

cause was that the software in the treatment

planning system did not warn or prompt the user

for confirmation that the most distal marker seed

was used for the digitization of the first

source-stopping position, and the fact that when

the system draws the isodose curves, there are no

graphical indications of the end of the treatment

path, or numbering of the treatment positions, or

any other indicator providing spatial orientation.

Actions Taken to Prevent Recurrence

Licensee: Corrective actions taken include:

1) modifying the annual retraining outline for

physician and physicist users to include a

discussion of the error for all future training;

2) modifying the procedure for the second

physicist check to address the error; and

3) modifying the procedures for the physician

check to address the error.

NRC: The NRC Region II conducted an

inspection of the licensee during the week of

September 18, 2000, to review the circumstances

associated with the misadministration. NRC

retained the services of a physician consultant to

review the details of this event.

10
Event 4: Unexpected exposure to Iridium-192

sources at Mercy Hospital, Iowa City, Iowa

Date and Place: September 11, 2000; Mercy

Hospital; Iowa City, Iowa.

Nature and Probable Consequences: Mercy

Hospital reported an unexpected exposure to a

radiation therapist, who was not a hospital

employee, from iridium-192 (Ir-192) medical seed

sources. The Iowa City Cancer Treatment Center

employed the individual, who was acting on the

hospital's behalf when the incident occurred. The

individual, unfamiliar with the mechanics of the

ordering process, thought that she had ordered a

ribbon with six dummy seeds, and a ribbon with six

Ir-192 seeds, when, in fact, the information that

was retained by the supplier did not include the

request for the dummy sources. A package

containing seeds from the manufacturer was

delivered to Mercy Hospital on September 11,

2000. The shipping papers for the package stated;

"1 each leader," and on the next line "1 each

ribbon with six seeds." The individual thought that

the "1 each leader" was the dummy seeds and the

"1 each ribbon with six seeds" was the Ir-192

seeds. The individual did not realize that the

package shipping papers meant one each leader

with one each ribbon with six seeds. The

individual removed what she thought were the

dummy sources and did not make a routine

radiation survey, in an attempt to verify her

assumption. The individual carried the ribbon of

Ir-192 seeds in her hand to a room where a

practice simulation of the upcoming procedure

was to be performed using dummy seeds. The

simulation was never performed because of some

problems with loading the ribbon of seeds into a

catheter. The ribbon of Ir-192 seeds was moved to

various locations in the simulator room during the

day and remained in that room until the next day.

The next morning, the individual discovered that

she had handled actual Ir-192 seeds. Total activity

of the Ir-192 seeds was 0.69 gigabequerel (GBq)

[18.54 millicurie (mCi)]. The State of Iowa

calculated that the individual received 29

centisievert (cSv) (29 rem) to her right hand. The

individual had the ribbon of Ir-192 seeds in her

hand for about 20 minutes. Her whole body dose,

as determined by her dosimeter reading, was 0.34

millisievert (mSv) [34 millirem (mrem)]. Several

people who entered the simulator room were also

exposed. The Radiation Safety Officer received a

whole body dose of 0.48 mSv (48 mrem); an

employee received a whole body dose of 0.13 mSv

(13 mrem); and an oncologist received a whole

body dose of 0.16 mSv (16 mrem).

Actions Taken to Prevent Recurrence

State Agency: The State of Iowa Department of

Public Health (IDPH), Radioactive Materials

Program, instructed Mercy Hospital that, as a

licensee, it is responsible for all activities

associated with its radioactive material license and

that this responsibility extends to individuals

outside the hospital if the individual is acting on

the hospital's behalf. IDPH therefore concluded

that it was Mercy's Hospital's responsibility to

assure that all appropriate training is provided to

such individuals, and in particular to employees of

the Iowa City Treatment Center who interfaced

with the radiological program. Iowa City Cancer

Treatment Center functions as a separate entity

and is not licensed by IDPH. IDPH issued Mercy

Hospital with a Notice of Violation identifying five

deficiencies. The deficiencies, which were

indicative of a breakdown in the control of

licensed activities and represented a lack of

attention toward those activities, were collectively

classified as an overall Severity Level III violation.

Event 5: TWo potential misadministrations caused

by calculation error involving iodine-125 (1-25)

temporary implants at Sibley Memorial Hospital,

Washington, District of Columbia

Date and Place: September 22, 2000; Sibley

Memorial Hospital, Washington, District of

Columbia.

Nature and Probable Consequences: The licensee

reported a medical event in which two patients

received greater radiation doses than prescribed,

because of calculational errors. The licensee

discovered that a mistake was made in ordering

sources for the medical procedures. A change had

been made to order sources in "air kerma

strength" instead of megabequerels (millicuries)

(mCi). The conversion is supposed to be the mCi

divided by 1.27, but the licensee multiplied by 1.27

instead. Two patients received 1-125 plaques to the

eye for melanoma and were both prescribed to

receive 7000 centigray (cGy) (7000 rad) to the

apex of the tumor over 120 hours. However, the

patients received 10,866 and 11,470 cGy (10,866

and 11,470 rads), respectively. The licensee does

not expect any consequences beyond what was

expected with the prescribed dose. The procedures

were performed in an attempt to preserve the

patients' eyes, as they would have been removed

otherwise. The licensee ascribes the cause of the

events to a calculation mistake, since the

conversion equation was not performed properly.

The licensee has determined that no other sources

were ordered with the wrong calculation.

11
Actions Taken to Prevent Recurrence

Licensee: The licensee stated that treatments

would be suspended until the quality assurance

software was checked, training was provided to

personnel, and written procedures were put in

place to ensure the accuracy of the treatment

calculation.

NRC: NRC Region I staff conducted an inspection

and reviewed the circumstances surrounding the

medical event and the potential causes. This

inspection confirmed that an error in the

calculation of dose from air kerma contributed to

the event. NRC retained the services of a

physician consultant to examine the events and

effects on the patients.

(Contact: Roberto Torres, 301-415-8112, e-mail:

rjt@nrc.gov)

12