Contents	 Page

1.	 From the Desk of the FSME Director ...............1

2.	 Appointment of Deputy Director, Division of

Intergovernmental Liaison and Rulemaking....... 2

3.	 Monitoring Visit and Public Meeting

Regarding DOE’s Disposal of Incidental

Waste at Idaho National Laboratory..................2

4.	 Agency Announces 2007 Fee Schedule ............3

5.	 RadMap: EPA’s New Emergency

Response Tool ...................................................3

 6. Clarification of the Two Part Requirement 

of Written Directives for Brachytherapy

Procedures (Except High Dose-Rate

Remote Afterloaders) ........................................4

7.	 Authorized User Training: Options

Available Under the Alternate Pathway for

Meeting the Classroom and Laboratory

Training Requirement........................................4

8.	 New Medical List Server...................................5

9.	 Generic Communications

(April 1, 2007 - June 30, 2007) .........................5

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

11. Significant Medical Events................................7

12.	 Selected Federal Register Notices

(May 1, 2007 - June 30, 2007) ..........................9

FROM THE DESK OF 

THE FSME DIRECTOR

With this edition of the Licensee

Newsletter, we have decided

to add a new feature, an open

letter from me, the Director of

the Office of Federal and State 

Materials and Environmental

Management Programs (FSME). I will try to use

this space to keep you posted on items and issues

of general interest since I view this as an important

communications tool between our office, and you, 

our licensees, and other key stakeholders.

For this first letter, I would like to share my 

philosophy on FSME’s role as Federal regulator

for nuclear materials, waste and environmental

activities. First, I would like to acknowledge the fact

that FSME and our regional partners regulate only

about 4,500 nuclear materials users, while the 34

Agreement States regulate nearly 18,000 users. With

Pennsylvania’s application already in the queue, and 

with New Jersey and Virginia also moving in the

direction of becoming Agreement States in the near

future, the U.S. Nuclear Regulatory Commission

(NRC) role will continue to evolve. In this context,

I want everyone to know that I take seriously my

responsibility to share information with the States

and leverage our talents as regulators with theirs. 

I think we at the NRC do many things well, and I

know that the States do too. 

Last Summer, when the Commission approved the

NRC reorganization that created FSME out of the

former Office of State and Tribal Programs and 

parts of the Office of Nuclear Material Safety and 

Safeguards, they did so to elevate the visibility of

State and Tribal programs to a major program office 

level and they directed me to remain engaged with

the States to strengthen their roles in the program to

make it a truly national materials program. I pledge

to you all that I will do everything I can to make that

a reality. 

The American public needs to know that all

22,000 plus nuclear materials licensees across

the country are using nuclear material in a safe

and secure manner, regardless of whether they

reside in an Agreement State or a non-Agreement

State. Licensees need to know that there will be a

consistent and predictable regulatory environment

regardless of the regulator.

One of the ways I think this can happen is through

dialogue and communication at all levels. The

FSME managers and staff, and our regional

counterparts, are committed to outreach. We

want to hear from other regulators, from local

stakeholders, and from licensees if our regulatory

LICENSEE NEWSLETTER

NUREG/BR-0117

No. 07-02

July 2007

Office of Federal and State Materials and Environmental Management Programs

Office of Nuclear Material Safety and Safeguards
2

approaches can be improved. We will use our

website, this Newsletter, generic communications,

Federal Register Notices, Information Notices,

Bulletins, licensee workshops, etc., and we will

travel across the country to engage with interested

stakeholders at all levels, as much as we can. That

is our commitment. We encourage you as licensees,

regulators, or interested stakeholders to let us know

if we are on track, or if we need to do better. While

we may not always agree, we want to do everything

we can to explain our regulatory decisions and to

operate in an open regulatory environment.

Charles Miller

Appointment of Patrice M. Bubar as Deputy 

Director, Division of Intergovernmental 

Liaison and Rulemaking

Patrice M. Bubar has been selected as Deputy

Director, Division of Intergovernmental Liaison and

Rulemaking, Office of Federal and State Materials 

and Environmental Management Programs. 

Ms. Bubar is a member of the Special Executive

Services and was most recently the Deputy Assistant

Secretary for Corporate Safety Analysis at the

U.S. Department of Energy (DOE). She began her

government career in 1978 with the Environmental

Protection Agency where she spent 13 years in

the Water, Superfund, and Radiation Programs. 

Since 1991, Ms. Bubar has served in a number

of senior positions at DOE, including Director,

Rocky Flats Program Office; Associate Deputy 

Assistant Secretary for Integration/Disposition; and 

Deputy Assistant Secretary for Integrated Safety

Management. Ms. Bubar received a B.S. degree in

Environmental Engineering from the University of

Pittsburgh.

Ms. Bubar has interacted with the NRC on many

waste and materials issues. She was DOE’s executive

lead on the May 2003 report jointly prepared by the

NRC and DOE entitled “Radiological Dispersal

Devices: An Initial Study to Identify Radioactive

Materials of Greatest Concern and Approaches to

Their Tracking, Tagging and Disposition.” She also

worked on waste disposal issues with NRC including

Greater Than Class C and Scrap Metals Recycling. 

Ms. Bubar has worked on international activities

with the NRC and other Federal agencies and

currently serves as the Vice-Chair of the Joint

Convention on Waste and Spent Fuel.

(Contact: Michael K. Williamson, Office of Federal 

and State Materials and Environmental Management

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

MONITORING VISIT AND PUBLIC 

MEETING REGARDING DOE’S 

DISPOSAL OF INCIDENTAL WASTE AT 

IDAHO NATIONAL LABORATORY

On April 24-25, 2007, the U.S. Nuclear Regulatory

Commission (NRC) staff conducted its first 

monitoring visit at the U.S. Department of Energy

(DOE) Idaho National Laboratory Tank Farm

Facility (INL TFF). The NRC staff also hosted a

public meeting in Idaho Falls, Idaho on April 25,

2007, to discuss NRC’s roles and responsibilities

under the Ronald Reagan National Defense

Authorization Act for FY 2005 (NDAA). The

NDAA requires DOE to consult with NRC on its 

waste determinations at INL and requires NRC to 

monitor DOE disposal actions to assess compliance

with 10 CFR Part 61, Subpart C, performance

objectives for low-level waste.

The INL TFF was established in 1953 to store

incidental waste as part of DOE’s effort to recover

fissile uranium by reprocessing spent nuclear fuel. 

There are a total of 15 stainless steel waste storage

tanks in TFF. Among them, eleven larger tanks

with 300,000 gallon capacity are also housed in

reinforced concrete vaults. DOE intends to close

the TFF in phases and the closure process comprises

tank system cleaning and stabilization activities. 

DOE tank cleaning began in 2002, and the final TFF 

closure is planned for 2012.

This monitoring visit was primarily focused on

waste storage tank grouting activities and DOE’s

radiation protection program to protect workers

and the public from radiation exposure during tank

closure operations. After a tour of the INL TFF site,

reviews of DOE’s records, and interviews with DOE

and its contractor personnel, NRC staff concluded

that DOE has an adequate quality assurance 

program pertaining to tank grouting operations and

an adequate radiation protection program in place 

to protect its personnel from radiation exposures. 

Another site visit is planned for later this year as

grouting operations at the TFF proceed.

The purpose of the public meeting was to provide

the public with a better understanding of NRC’s

activities in implementing the NDAA and in

reviewing DOE’s waste determination for the INL

TFF. NRC staff presented an overview of NRC’s

implementation of the NDAA, the history of NRC’s

involvement in DOE waste determinations, and the

criteria for waste determinations under the NDAA. 

NRC staff also presented an overview of the
3

October 2006 Technical Evaluation Report which

documented the staff’s review of DOE’s draft waste

determination for the INL TFF, as well as planned

NRC monitoring activities of DOE waste disposal

operations at the INL. The NRC staff answered and

discussed a wide range of questions and comments 

from the public pertaining to DOE’s waste disposal

and tank closure activities. The public meeting was

well attended and included representatives from

the Snake River Alliance, the Idaho Department of

Environmental Quality, DOE, and the office of U.S. 

Senator Larry Craig.

(Contact: Xiaosong Yin, FSME/DWMEP,

301-415-7640, Fax: 301-415-5397,

Mail Stop: T8 F5; e-mail: xxy@nrc.gov)

Agency Announces 2007 Fee Schedule

The NRC has announced the licensing, inspection,

and annual fees it will charge licensees and

applicants this fiscal year.

Congress requires that the agency recover most of 

its annual appropriated budget through two types

of fees, one for specific services and the other for 

generic regulatory expenses and other costs. The

fees are paid to the U.S. Treasury and go into the

general fund.

For fiscal year 2007, NRC must recover 90 percent 

of its budget, less the amounts appropriated from the

Nuclear Waste Fund for high-level waste activities

and from general funds for waste-incidentalto-reprocessing and generic homeland security

activities. For FY 2007, the amount to be recovered

is approximately $670.5 million, about $45 million

more than in 2006.

The final rule establishes a single hourly rate of $258 

for activities in both the Nuclear Reactor Safety

Program and the Nuclear Materials and Waste Safety

Program. This represents an increase from $217

for the reactor program and $214 for the materials

program, and it reflects a revised estimate of staff 

hours spent on specific activities, such as licensing 

actions, inspections, and regulatory development.

Annual fees will increase for power reactor

licensees, but will decrease for most other types

of licensees. You can read more about the fees at

http://www.nrc.gov/reading-rm/doc-collections/

news/2007/07-069.html.

RadMap: EPA’s New Emergency 

Response Tool

RadMap is the U.S. Environmental Protection

Agency’s (EPA) new interactive desktop tool

featuring a Geographic Information Systems (GIS)

map with quick access to information on long-term 

radiation monitoring locations across the country. 

Designed for use by emergency responders, RadMap

provides access to key information about the

monitors and the area surrounding them. There is

currently information on a few hundred monitors in

RadMap including monitoring systems sponsored

by EPA, some States and DOE facilities. We

would welcome NRC participation and will seek

participation of additional States as well.

Registered users can download RadMap onto their

desktop computer, a critical feature should other

systems fail during an emergency. In the event of

a radiation release, RadMap can help emergency

responders collect information, develop assessments,

and determine the placement of deployable monitors.

Users can zoom in on an area of the map to identify

information about the monitor and to characterize

the monitor location.

RadMap provides easy access to:

•	 Monitor locations

• Points of contact for specific monitoring systems

•	 Data being collected and how often

•	 Real-time and long-term data, where available

online

•	 Information on population centers from the 2000

census

•	 Geographic features such as nearby roads and

bodies of water

•	 Distances from point to point

RadMap helps fulfill one of EPA’s critical homeland 

security responsibilities under the National Response

Plan, and addresses recommendations made by

both the Conference of Radiation Control Program

Directors and EPA’s Science Advisory Board (SAB).

EPA is working to make RadMap a complete and

useful emergency response tool. If you would like

to see how RadMap works, would like additional

information or can provide information

to help complete the map, contact Jacolyn White

at white.jacolyn@epa.gov, or give her a call at 

202-343-9474. 
4

Clarification of the Two Part Requirement 

of Written Directives for Brachytherapy 

Procedures (Except High Dose-Rate Remote 

Afterloaders)

Written directives are required for higher-risk 

procedures to ensure that there is a high degree of

confidence that the radiation dose from byproduct 

material will be administered according to the

directions of the authorized user (AU) physician. 

During some recent inspections that have been

conducted in response to reported medical events,

the NRC inspectors have found that several licensees

are not aware that the written directive requirements 

for manual brachytherapy and low, medium, and

pulsed-dose rate remote afterloader brachytherapy

require that the written directive be completed in 

two parts [see 10 CFR 35.40(b)(6)]. For other

administrations requiring a written directive (e.g., 

high-dose rate remote afterloading brachytherapy),

the entire written directive must be completed before

the administration. 

For certain types of manual brachytherapy (e.g.,

permanent implant manual brachytherapy), the

number of sources used is often not known until the

procedure is being performed. Therefore, the written

directive requirements for manual brachytherapy as 

well as low, medium, and pulsed-dose rate remote

afterloader brachytherapy [10 CFR 35.40(b)(6)],

allow for a portion of the written directive to be

completed after the procedure has begun.

The first part of the written directive must be 

completed before implantation of the sources,

and must include the following information: the

patient’s name, treatment site, the radionuclide,

and dose. The written directive must be signed

and dated by the AU physician before the radiation

therapy treatment begins.

The second part of the written directive is completed

after implantation, but before completion of

the procedure, and must include the following

information: the radionuclide, treatment site,

number of sources, and the total source strength and

exposure time (or the total dose).

As stated in 10 CFR 35.40(b)(6)(ii), the second

part of the written directive must be completed

before completion of the procedure, which is

the time when the sources are removed from the

patient for temporary manual brachytherapy,

and low, medium, and pulsed-dose rate remote

afterloader brachytherapy. In cases of permanent

implant manual brachytherapy, “completion of the

procedure” is more difficult to define. Consequently, 

the written directive requirements in 10 CFR 

35.40(b)(6) will be revised for permanent implant

brachytherapy.

(Technical Contact: Cindy Flannery, FSME,

301-415-0223; e-mail: cmf@nrc.gov)

Authorized User Training: Options Available 

Under the Alternate Pathway for Meeting 

the Classroom and Laboratory Training 

Requirement

Physicians seeking to become authorized users (AU)

for the medical use of unsealed byproduct material

are required to complete a specified total number 

of hours of training and experience (T&E). For

physicians seeking AU status under the alternate

pathway (the pathway for approval that is granted

based on NRC’s evaluation of an individual’s

training and experience) the regulations further

specify that the minimum number of those total

hours of T&E are to be devoted to “classroom and

laboratory training.” The remainder of the required 

total hours of T&E are spent on “supervised work

experience.” 

Proposed AUs have options that add flexibility to 

the manner in which they can meet the requirement 

for the minimum number of hours in “classroom and

laboratory training.”

The required “classroom and laboratory training” 

may be obtained in any number of settings,

locations, and educational situations. For example,

at some medical teaching/university institutions,

a course may be provided for that particular need

and taught in consecutive days. In other training

programs, the period may be a semester or quarter 

as part of the formal curriculum. Applicants may

also fulfill the “classroom and laboratory training” 

requirement in a setting other than the traditional 

classroom setting. NRC broadly interprets

“classroom and laboratory training” to include

various types of instruction, including online

training. NRC will evaluate training on a case-bycase basis, however, as long as the training meets

the specific clock hour requirements and the subject 

matter relates to radiation safety and safe handling

of byproduct material for the uses for which

authorization is being requested, NRC generally will 

accept such training. 

Another option that adds flexibility in meeting the 

requirement for the minimum number of hours in 

“classroom and laboratory training” is that some of

the clinical laboratory experience may be credited

toward the “classroom and laboratory training.” All
5

hours credited to “classroom and laboratory training”

must include one of the subject areas listed in the

applicable regulations and it must relate directly to

radiation safety tasks or hands-on use of byproduct

material for the uses for which authorization is

being sought. Any training that is obtained in a

clinical laboratory setting that is credited toward the

“classroom and laboratory training” cannot also be

credited toward the “supervised work experience”

category of the specified total number of T&E 

hours. For instance, if an applicant received a given

number of hours in a clinical nuclear medicine

laboratory in the subject area of instrumentation and

credited those hours to that required topic under the 

“classroom and laboratory training” category of the

T&E, those same hours, although applicable to the

subject matter, could not also be credited toward

the required topic of performing checks for proper 

operation of survey meters under the “supervised

work experience” category of the T&E.

(Contact: Cindy Flannery, Office of Federal and 

State Materials and Environmental Management

Programs, 301-415-0223; e-mail: cmf@nrc.gov)

New Medical List Server

NRC is aware that some stakeholders may benefit 

from more timely notification of the issuance 

of medical-related generic communications,

newsletters, and Federal Register Notices. To serve

the needs of these stakeholders, the NRC’s Office 

of Federal and State Materials and Environmental

Management Programs (FSME) has established

a new list server that will send automatic e-mail

notifications of the publication of these items.

Individuals may subscribe or unsubscribe to the new

list server by sending an e-mail to medical-gc@

nrc.gov, with “Subscribe” or “Unsubscribe” in the

subject line. For guidance pertaining to the use of

the list server, NRC staff asks that users be mindful

of the points listed below.

•	 Do not reply to e-mails sent from the list server

e-mail address medical-gc@nrc.gov. It is 

intended for subscribing and unsubscribing to

the list server only.

•	 Questions pertaining to the list server itself should

be sent to Med-listserverquestions@nrc.gov.

•	 Questions pertaining to the content of generic

communications, Federal Register notices and

newsletter articles should be directed to the

technical contact(s) identified in the applicable 

document.

(CONTACT: Angela R. McIntosh, FSME,

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

GENERIC COMMUNICATIONS ISSUED 

(April 1, 2007 - June 30, 2007)

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/readingrm/doc-collections/ en-comm/. 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 Angela McIntosh, 301-415-5030 or by email: arm@nrc.gov.

Bulletins (BLs)

None.

Generic Letters (Gls)

None.

Information Notices (INs)

IN 2007-13, “Use of As-Found Conditions to 

Evaluate Criticality-related Process Upsets at 

Fuel Cycle Facilities” was issued April 4, 2007. 

This IN was issued to all licensees authorized to

possess a critical mass of special nuclear material. 

(Technical Contact: Dennis Morey, NMSS,

301-415-6107; e-mail: dcm@nrc.gov)

IN 2007-16, “Common Violations of the Increased 

Controls Requirements and Related Guidance 

Documents,” was issued May 2, 2007. This IN was

issued to all licensees who are implementing the

U.S. Nuclear Regulatory Commission (NRC) Order

Imposing Increased Controls (EA-05-090), issued

November 14, 2005, and December 22, 2005.

(Technical Contact: Joshua Palotay, FSME,

301-415-6231; e-mail: jxp5@nrc.gov)

IN 2007-19, “Fire Protection Equipment Recalls 

and Counterfeit Notices,” was issued May 21,

2007. This IN was issued to all holders of operating

licenses for nuclear power reactors and fuel cycle

facilities; except those licensees for reactors that 

have permanently ceased operations and who have
6

certified that fuel has been permanently removed 

from the reactor vessel; and except those licensees 

for decommissioned fuel cycle facilities.

(Technical Contacts: Naeem Iqbal, NRR, 

301-415-3346; e-mail: nxi@nrc.gov; and 

Dennis Andrukat, NRR; e-mail: dwa1@nrc.gov)

IN 2007-20, “Use of Blank Ammunition,” was

issued June 11, 2007. This IN was issued to all

power reactors, Category I fuel cycle facilities,

independent spent fuel storage installations,

conversion facility, and gaseous diffusion plants. 

(Technical Contact: Joseph Willis, NSIR,

301-415-6869; e-mail: jxw3@nrc.gov)

Regulatory Issue Summaries (RIS’s)

RIS 2007-07, “Clarification of Increased Controls 

for Licensees That Possess Collocated Radioactive 

Material During Transportation Activities,” was

issued April 5, 2007. This RIS was issued to all U.S.

Nuclear Regulatory Commission (NRC) licensees

issued NRC’s Order Imposing Increased Controls

and all Radiation Control Program Directors and

State Liaison Officers. 

(Technical Contact: Christian Einberg, FSME,

301-415-5422; e-mail: cee1@nrc.gov)

RIS 2007-09, “Examples of Recurring Requests 

for Additional Information (RAIs) for 10 CFR 

Part 71 and 72 Applications,” was issued May 4,

2007. This RIS was issued to all holders of, and

applicants for, a: (1) 10 CFR Part 71 certificate 

of compliance (CoC) for a radioactive material

transportation package; (2) 10 CFR Part 72 CoC 

for a spent fuel storage cask; and (3) 10 CFR Part 72 

specific license for an independent spent fuel storage 

installation (ISFSI). 

(Technical Contact: Jeremy Smith, NMSS,

301-492-3340; e-mail: jas5@nrc.gov)

RIS 2007-10, “Subscriptions to New List Server 

for Automatic Notifications of Medical-related 

Generic Communications, Federal Register 

Notices And Newsletters,” issued May 15, 2007. 

This RIS was issued to all U.S. Nuclear Regulatory

Commission (NRC) medical-use licensees and NRC

Master Materials licensees. All Radiation Control

Program Directors and State Liaison Officers 

(Technical Contact: Angela McIntosh, FSME,

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

RIS 2007-14, “Fingerprinting Requirements for 

Licensees Implementing the Increased Control 

Order,” was issued June 5, 2007. This RIS was

issued to all U.S. Nuclear Regulatory Commission

licensees that have received the Increased Controls

requirements, and all Agreement State Radiation 

Control Program Directors and State Liaison

Officers.

(Technical Contact: Nima Ashkeboussi, FSME,

301-415-7637; e-mail: naa@nrc.gov)

RIS 2007-15, “Unescorted Access to Materials 

for Non-Manufacturer and Distributor Service 

Providers,” was issued June 5, 2007. This RIS was

issued to all U.S. Nuclear Regulatory Commission

licensees, and all Agreement State Radiation Control

Program Directors and State Liaison Officers.

(Technical Contact: Nima Ashkeboussi, FSME,

301-415-7637; e-mail: naa@nrc.gov)

SIGNIFICANT ENFORCEMENT ACTIONS

The NRC’s enforcement program can be accessed

via 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,” “ADAMS Documents”. Help

using ADAMS is available from the NRC Public

Document Room, telephone: 

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

Portable Gauges

Hirata & Associates, Inc. (EA-06-300)

On June 5, 2007, a Notice of Violation was issued

for a Severity Level III violation involving the

failure to use a minimum of two independent

physical controls that formed tangible barriers to

secure portable gauges from unauthorized removal

when the gauges were not under the control and

constant surveillance of licensee personnel.

U.S. Engineering Laboratories, Inc. (EA-07-035)

On May 22, 2007, a Notice of Violation (NOV)

and Proposed Imposition of Civil Penalty in the

amount of $9,750 was issued for a Severity Level

III violation involving the failure to secure licensed

material from unauthorized removal resulting in the

loss of a portable nuclear density gauge. The gauge

was missing for approximately 5-months before

it was found in the public domain in Philadelphia,

Pennsylvania. A second NOV involved the failure to
7

immediately report the loss of the licensed material

to the NRC.

Medical

Englewood Hospital and Medical Center 

(EA-06-309)

On April 30, 2007, a Notice of Violation and

Proposed Imposition of Civil Penalty in the

amount of $3,250 was issued for a Severity Level

III problem involving the submittal of inaccurate

information to the NRC in support of a request 

to amend the license to add an individual as an

Authorized Medical Physicist.

Mercy Hospital (EA-07-018)

On April 5, 2007, a Notice of Violation was issued

for a Severity Level III violation involving the

failure to secure from unauthorized removal or limit

access to a High Dose Rate Afterloader. The device

was stored in a treatment room, and access to which

was not restricted as required. 

Milton A. Hershey Medical Center (EA-07-048)

On April 4, 2007, a Notice of Violation was issued

for a Severity Level III violation involving the

failure to secure from unauthorized removal or limit

access to radioactive material located in the nuclear

medicine department hot lab, which is a controlled

area. In addition, the licensee did not control and

maintain constant surveillance of this licensed

material.

Industrial Radiography

Accurate NDE and Inspection, LLC (EA-06-281)

On March 20, 2007, a Notice of Violation and

Proposed Imposition of Civil Penalty in the amount

of $13,000 was issued for a Severity Level III

problem. The violations involved the failure to

secure from unauthorized removal or limit access

to a radiographic exposure device that was being

improperly stored on an offshore platform, which

was in a controlled area or unrestricted area; the 

failure to wear required personnel dosimetry 

during radiographic operations; and the failure 

to provide complete and accurate information on

documents provided to an NRC inspector. Because

willfulness was associated with the problem, the

NRC considered whether credit was warranted for

Identification and Corrective Action in accordance 

with the civil penalty assessment process in the NRC

Enforcement Policy, and determined that in this case,

it was not.

Individual Actions

John Branyan (IA-07-010)

On May 22, 2007, a Notice of Violation was

issued for a Severity Level III violation involving

the individual’s deliberate misconduct which

caused his former employer, U.S. Engineering

Laboratories, Inc., to be in violation of 10 CFR

20.2201. Specifically the individual failed to report 

a portable nuclear density gauge as lost or missing

when the location of the gauge was unknown

for approximately 5-months. The gauge was

subsequently found in the public domain.

Lee-Cheng (Jean) Peng (IA-07-023)

On April 30, 2007, a Notice of Violation was

issued for a Severity Level III violation involving

the deliberate submittal of information that the

individual knew to be inaccurate, to an NRC

licensee. The licensee subsequently submitted the 

inaccurate information to the NRC causing the

licensee to be in violation of NRC regulations.

Ching Chong Yang, Ph.D (IA-07-022)

On April 30, 2007, a Notice of Violation was issued

for a Severity Level III violation involving the

individual’s deliberate misconduct that caused two

NRC licensees to be in violation of 10 CFR 30.9. 

Specifically, the individual submitted information 

to each licensee that he knew to be inaccurate

in violation of 10 CFR 30.10. The licensees

subsequently submitted the inaccurate information 

to the NRC causing them to be in violation of NRC

regulations.	

SIGNIFICANT MEDICAL EVENTS 

The NRC’s enforcement program can be accessed

via NRC’s homepage [http://www.nrc.gov/] under

“Public Meetings and Involvement.” Documents

related to cases can be accessed at [http://www.

nrc.gov/], “Electronic Reading Room” “ADAMS

Documents.” 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.
8

Event 1: Brachytherapy Medical Event Due to Error

with Treatment Planning System

Date and Place: March 7, 2007, New York.

Nature and Probable Causes: The licensee reported

a brachytherapy misadministration event to the

New York State Department of Health. The event

involved a 31 year old female patient with a history

of vaginal cancer. The treatment involved the use

of both Cesium-137 and Iridium-192 seeds. The

licensee ordered 11 ribbons of Iridium-192 seeds

from Best Industries. Each ribbon contained 8

seeds with an activity of 1.855 milligram radium

equivalent (3.19 millicuries, or 118 Megabecquerels) 

per seed. The patient was to be administered a

total dose of 2,500 centigray (rads) via interstitial

brachytherapy, to be delivered to the 50 centigray

(rad) isodose line for a total treatment time of

50 hours.

On March 6, 2007, a Syed template was used to

place the Iridium-192 seeds into the patient, and

the Cesium-137 seeds were placed into the patient

using a tandem applicator. Late in the morning of

March 7, 2007, the medical physicist performed a

manual check of the treatment plan calculations,

and discovered that the hand calculations indicated

a significantly higher dose rate than what was 

generated using the treatment planning software. 

The ensuing investigation, which took several hours,

revealed that the original treatment plan was in error. 

At 5:30 p.m. on March 7, 2007, after 27 hours of

treatment, the seeds were removed from the patient.

The patient received an estimated dose of 4,590

centigray (rad) to the treatment site, rather than the

intended 2,500 centigray (rad). The rectal dose

was 7,300 centigray (rad). The radiation oncologist

disclosed that the patient is at risk for radiation

cystitis, rectal proctitis, and more importantly, fistula 

formation between the rectum and the vagina. The

patient will be monitored closely over the next year

by both her gynecologic oncologist and the radiation

oncologist. The patient is being treated with broad

spectrum antibiotics along with daily treatments in a

hyperbaric oxygen chamber

The primary cause was the use of an inappropriate

Dose Rate Factor (DRF) in the treatment planning

system. The value used corresponded to the DRF

for air kerma, however, the seed strength entered

was in milligram radium equivalent. Other causes 

and/or contributing factors include: (1) Failure to

check the treatment pre-plan before the seeds arrived

although there was time to do so; failure to double 

check the calculations either prior to the implant

or shortly thereafter; (2) the use of a treatment 

planning system that underwent acceptance testing

for Cs-137 and I-125, but not Iridium-192; and (3) 

lack of recent experience preparing a treatment using

Iridium-192. Neither the physicist nor the radiation

oncologist had prepared a treatment using Ir-192 in

six years. Due to their recent lack of experience, it

would have been prudent to obtain additional review

or outside review.

Event 2: Overdose Due to Pharmacy Error

Date and Place: April 24, 2007, Ashville, North

Carolina

Nature and Probable Causes: The State of North

Carolina was notified on April 26, 2007, of an event 

that involved a mis-drawn and mislabeled dose from

a pharmacy in Ashville, North Carolina. The written

directive from the hospital was for 30 microcuries

for a diagnostic thyroid scan, but 33.9 millicuries

was delivered labeled as 33.9 microcuries. The

dose was administered on April 24, 2007, and the

error was found on April 26, 2007. The patient

and physician were notified, and the licensee is 

following up with the pharmacy. No information

is available on any potential medical impact of the

misadministration on the patient.

The licensee missed the error because although

the numbers were read, the units were not verified 

(microcuries vs. millicuries).

Event 3: Exposure to Embryo/Fetus

Date and Place: May 29, 2007, St. Louis, Missouri

Nature and Probable Causes: The licensee reported

that cancer treatment to a patient using

I-131 resulted in a dose to an embryo/fetus. The

patient was seen by her prescribing physician on

May 22, 2007, concerning cancer treatment with

I-131. The licensee conducted a pregnancy test on

the patient with negative results. The patient was

advised not to get pregnant prior to the treatment. 

On May 29, 2007, the treatment was using 4.64

gigabecquerel (125.5 millicuries) of I-131. On 

May 30, 2007, the patient stated that she performed

a home pregnancy test with positive results. The

licensee performed another test on May 30, 2007,

with positive results. Staff calculated a dose to

the patient’s uterus as an approximation for the

dose received by the embryo/fetus. The dose was

estimated to be between 25 and 34 cGy (rad). The

risk to the embryo/fetus is being determined by the
9

licensee. The possible effects will be discussed with

the patient at a future date.

(General Contact: Angela R. McIntosh, FSME, 301-

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

SELECTED FEDERAL REGISTER NOTICES

(May 1, 2007 - June 30, 2007)

“Report to Congress on Abnormal Occurrences

Fiscal Year 2006; Dissemination of Information” 

72 FR 25339, May 4, 2007.

(Contact: Andrew L. Bates, Office of the Secretary, 

301-415-1963; e-mail: alb@nrc.gov)

10 CFR Part 72 [RIN 3150-AI13] “List of Approved

Spent Fuel Storage Casks: NAC-MPC Revision 5; 

Direct Final Rule” 72 FR 26535, May 10, 2007.

(Contact: Jayne M. McCausland, Office of Federal 

and State Materials and Environmental Management

Programs, 301-415-6219; e-mail: jmm2@nrc.gov)

10 CFR Part 72 [RIN 3150-AI13] “List of Approved

Spent Fuel Storage Casks: NAC-MPC Revision 5; 

Companion proposed rule” 72 FR 26568, May 10,

2007.

(Contact: Jayne M. McCausland, Office of Federal 

and State Materials and Environmental Management

Programs, 301-415-6219; e-mail: jmm2@nrc.gov)

10 CFR Part 51 [Docket No. PRM-51-12] “State

of California; Receipt of Petition for Rulemaking” 

72 FR 27068, May 14, 2007.

(Contact: Michael T. Lesar, Office of 

Administration, 301-415-7163 or Toll Free: 

800-368-5642)

10 CFR Parts 11 and 25 [RIN 3150-AH99] “Access

Authorization Fees” 72 FR 27408, May 16, 2007.

(Contact: Emily Banks, Office of Administration, 

301 415-0320; e-mail: erb@nrc.gov)

10 CFR Parts 26, 60, 63, 73, and 74 [RIN 3150-

AI06] “Geologic Repository Operations Area

Security and Material Control and Accounting

Requirements” 72 FR 27766, May 17, 2007.

(Contact: Merri Horn, Office of Federal and 

State Materials and Environmental Management

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

10 CFR Part 1[RIN 3150-AI17] “Emergency

Preparedness Policies Developed for Nuclear

Materials Facilities” 72 FR 28449, May 21, 2007.

(Contact: Kevin R. O’Sullivan, Office of Federal 

and State Materials and Environmental Management

Programs, 301-415-8112; e-mail: kro2@nrc.gov)

10 CFR Part 1 [RIN 3150-AI17] “Emergency

Preparedness Policies Developed for Nuclear

Materials Facilities” 72 FR 28455, May 21, 2007.

(Contact: Kevin R. O’Sullivan, Office of Federal 

and State Materials and Environmental Management

Programs, 301-415-8112; e-mail: kro2@nrc.gov)

10 CFR Part 50 [Docket No. PRM-50-84] “Mark

Edward Leyse; Receipt of Petition for Rulemaking” 

72 FR 28902, May 23, 2007.

(Contact: Michael T. Lesar, Office of 

Administration, 301-415-7163; Toll-Free: 

1-800-368-5642; e-mail: mtl@nrc.gov)

10 CFR Parts 170 and 171 [RIN 3150-AI00]

“Revision of Fee Schedules; Fee Recovery for 

FY 2007” 72 FR 31401, June 6, 2007.

(Contact: Renu Suri, Office of the Chief Financial 

Officer, 301-415-0161; e-mail: rxs6@nrc.gov)

Notice of Availability; Draft NUREG-1574, 

Revision 2, “Standard Review Plan on Transfer and

Amendment of Antitrust License Conditions and

Antitrust Enforcement” 72 FR 31626, June 7, 2007.

(Contact: Steven R. Hom, Office of Nuclear Reactor 

Regulation, 301-415-1537; e-mail: srh@nrc.gov)

10 CFR Part 2 [RIN 3150-AI08] “Interlocutory

Review of Rulings on Requests by Potential Parties 

for Access to Sensitive Unclassified Non-Safeguards 

Information and Safeguards Information”

72 FR 32018, June 11, 2007.

(Contact: Patrick Moulding, Office of the General 

Counsel, 301-415-2549; e-mail: pam3@nrc.gov)

10 CFR Chapter I [RIN 3150-AI18] “Administrative

Changes” 72 FR 33386, June 18, 2007.

(Contact: Thomas Smith, Office of Information 

Services, 301-415-7043; e-mail: TES@nrc.gov)

“Commonwealth of Pennsylvania: Draft NRC

Staff Assessment of a Proposed Agreement

Between the Nuclear Regulatory Commission and
10

the Commonwealth of Pennsylvania” 72 FR 33541,

June 18, 2007.

(Contact: Andrew N. Mauer, Office of Federal and 

State Materials and Environmental Management

Programs, 301-415-3962; e-mail: to anm@nrc.gov)

NUREG/CR-6931 Volume 1, ‘‘CAROLFIRE Test

Report Volume 1: General Test Descriptions and

the Analysis of Circuit Response Data, Draft for

Public Comment,’’ and NUREG/CR-6931 Volume

2, ‘‘CAROLFIRE Test Report Volume 2: Cable Fire

Response Data for Fire Model Improvement, Draft

for Public Comment-Revision 1;” Extension 

of Comment Period, 72 FR 34488, June 22, 2007.

(Contact: Mark H. Salley, Office of Nuclear 

Regulatory Research, 301-415-2840; 

e-mail: mxs3@nrc.gov)

“Commonwealth of Pennsylvania: Draft NRC Staff

Assessment of a Proposed Agreement Between

the Nuclear Regulatory Commission and the

Commonwealth of Pennsylvania” (Second Printing)

72 FR 34728, June 25, 2007.

	 	

(Contact: Andrew N. Mauer, Office of Federal and 

State Materials and Environmental Management

Programs, 301-415-3962; e-mail: anm@nrc.gov.)

10 CFR Part 70 [RIN 3150-AH62] “Conforming

Administrative Changes” 72 FR 35144,

June 27, 2007.

(Contact: Michael K. Williamson, Office of Federal 

and State Materials and Environmental Management

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

10 CFR Part 34 [PRM-34-06] “Organization

of Agreement States, Petition for Rulemaking”

Meeting, 72 FR June 27, 2007.

(Contact: Thomas Young, Office of Federal and 

State Materials and Environmental Management

Programs, 301-415-5795; e-mail: tfy@nrc.gov) 

“Governors’ Designees Receiving Advance

Notification of Transportation of Nuclear Waste” 

72 FR 35732, June 29, 2007.

Jenny C. Tobin, Office of Federal and State 

Materials and Environmental Management

Programs, 301-415-2328; e-mail: jct1@nrc.gov.

(General Contact: Gwendolyn Davis, Office of 

Federal and State Materials and Environmental

Management Programs, 301-415-8165; e-mail: 

gxd@nrc.gov)

NOTE TO READERS: In an attempt to keep the

FSME-NMSS Licensee Newsletter relevant,

useful and informative, feedback on the content

of the newsletter is welcome. Readers desiring

to contribute articles, self-explanatory diagrams,

suggestions for future articles, bulletins, web-site

postings, and other items of interest to the FSMENMSS Licensee Newsletter readership, should

contact Michael Williamson or Gwendolyn Davis,

from the Office of Federal and State Materials and 

Environmental Management Programs, Rulemaking

Branch A. Mr Williamson may be contacted at

301-415-6234 or mkw1@nrc.gov. Ms. Davis may 

be contacted at 301-415-8165 or gxd@nrc.gov. In 

addition, to ensure proper delivery of the FSMENMSS Licensee Newsletter, please report any

address changes to Mr. Williamson to prevent any

interruption of service.

Please send written correspondence

and requests to: 

Michael K. Williamson, Editor

FSME-NMSS Licensee Newsletter

Office of Federal and State 

Materials and Environmental

Management Programs

U.S. Nuclear Regulatory Commission

Two White Flint North, Mail Stop: T-8-F42

Washington, D.C. 20555-0001
Printed

on recycled

paper

Federal Recycling Program
UNITED STATES

NUCLEAR REGULATORY COMMISSION

WASHINGTON, DC 20555-0001

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