1

LICENSEE NEWSLETTER

NUREG/BR-0117, No. 09-01 Spring 2009

Office of Federal & State Materials &

Environmental Management Programs

INSIDE THIS ISSUE

NRC’S Revised Policy on the 

Licensing Requirements for 

Surgical Excision Associated 

with Sentinel Lymph Node 

Biopsy Procedures......................................2

Last Phase of Waiver Terminations 

of NRC Regulatory Authority 

for Certain Naturally 

Occurring and AcceleratorProduced Radioactive 

Material (NARM)..........................................2

From the Desk of the 

FSME Director..............................................3

NRC Completes the 

Commonwealth of Virginia 

Agreement....................................................4

NRC Issues Confirmatory 

Order To Mattingly Testing 

Services..........................................................5

Licensee Bankruptcy and/or 

Change of Control......................................5

NRC is Seeking Public Comment on 

Regulatory Issues and Options for 

Potential Changes to the Agency’s 

Radiation Protection Regulations.........6

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

Generic Communications Issued 

(January 1, 2009 - 

March 31, 2009)...........................................8

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

Selected Federal Register Notices

(January 16, 2009 – 

March 25, 2009............................................9

In Remembrance

It is with deep sympathy that we 

inform our readers of the passing 

of Mr. Michael K. Williamson, the 

editor of the FSME Newsletter, on 

May 4, 2009.

Mr. Williamson joined the NRC in 

March 2002, as a General Physical 

Scientist/Project Manager in 

the former Division of Industrial 

and Medical Nuclear Safety. Mr. 

Williamson was involved in 

the writing and development 

of inspection procedures and 

guidance as well as maintaining 

the nuclear materials portion 

of the NRC’s Inspection Manual. 

He was also involved in the 

development of guidance that 

appears in the NUREG-1556 series. 

Most recently, he was promoted 

to a Health Physicist/Project 

Manager in the FSME’s Division of 

Intergovernmental Liaison and 

Rulemaking where he served as 

the lead Project Manager for the 

Expansion of the National Source 

Tracking System rulemaking.

Prior to joining the NRC, Mr. 

Williamson was a Health Physics 

Technologist in the United States 

Army and retired after twenty 

years of service. He served 

at numerous locations and 

participated in various projects, 

such as the Johnston Atoll 

Plutonium Clean-up Project, and 

served as the lead technician 

on various emergency response 

teams responsible for responding 

to accidents or incidents involving 

radiological and biological 

warfare agents. While in the 

service, Mr. Williamson received 

his B.S. degree in Health Care 

Administration from Southern Illinois 

University at Carbondale, graduating 

Magna cum Laude.

Mr. Williamson was a valued employee 

and friend and he will be greatly 

missed.
2

Phase 1 of terminations occurred 

on November 30, 2007, and Phase 

2 on September 30, 2008. NRC 

is now preparing for Phase 3, the 

last phase, which will occur on 

August 7, 2009 (74 FR 5797). This 

final phase will include Alaska, 

Connecticut, Hawaii, Michigan, 

New Jersey, and Canadian 

licensees that are under NRC 

jurisdiction. 

NARM users in non-Agreement 

States and US territories are 

required to: 

(1)apply for license amendments 

for the new byproduct material 

within six months from the date 

the waiver is terminated, if they 

hold an NRC specific byproduct 

materials license, or 

(2)submit a license application for 

the new byproduct material 

within 12 months from the date 

the waiver is terminated. 

For existing NRC licensees, it 

should be noted that NRC will 

not be amending licenses to 

include authorization to produce 

radioactive material using an 

accelerator; a separate license will 

be required for these activities. 

Therefore, existing licensees 

should submit a new license 

application to obtain authorization 

for the production of radioactive 

materials using an accelerator. 

Also, new NRC license applicants 

that are seeking authorization 

to produce radioactive materials 

using an accelerator should 

submit a license application for 

their production of radioactive 

materials authorization and submit 

a separate license application for 

any other radioactive material 

authorizations they may be 

seeking (e.g., manufacturing of 

continued on page 4

NRC’S REVISED POLICY 

ON THE LICENSING 

REQUIREMENTS FOR 

SURGICAL EXCISION 

ASSOCIATED WITH 

SENTINEL LYMPH NODE 

BIOPSY PROCEDURES

In the March 2006 edition of the 

Nuclear Materials Safety and 

Safeguards quarterly newsletter, 

an article was published which 

stated the Nuclear Regulatory 

Commission’s (NRC) policy, at 

that time, that surgical removal 

and biopsy of radioactive tissue 

must be performed under an NRC 

medical use license.

Surgical facilities performing 

only the surgical excisions, other 

stakeholders, and NRC’s Advisory 

Committee on the Medical Use 

of Isotopes (ACMUI) expressed 

opposition to licensing the 

surgical removal of the sentinel 

lymph node and requiring an 

NRC byproduct material license 

for facilities performing only 

this surgical procedure. Those 

opposing this policy cited the 

significant medical benefits 

provided by the sentinel lymph 

node biopsy procedures combined 

with the low risk of the byproduct 

material, which is minimized by 

the small dosage involved; the 

small fraction of the dosage taken 

up in tissue that is excised; and 

the hours of radioactive decay in 

the time between injection and 

excision.

NRC considered the rationale 

provided by ACMUI and 

stakeholders and has determined 

that there is a sound basis for 

revising its policy on the licensing 

of surgical facilities. NRC’s 

revised policy on this issue is 

described in NRC Regulatory Issue 

Summary (RIS) 2008-31, Licensing 

Requirements for Sentinel Lymph 

Node Biopsy, which can be found 

at http://www.nrc.gov/readingrm/doc-collections/gen-comm/

reg-issues/2008/index.html. RIS 

2008-31 states that the surgical 

removal of the lymph nodes does 

not require an NRC byproduct 

material license as long as the 

excised tissue does not contain 

more than 100 microCuries (3.7 

megabecquerels) of technetium99m. With regard to the pathology 

of excised sentinel lymph 

node tissue, the NRC’s position 

continues to be that excised 

tissue may be transferred to a 

non-licensed facility for pathology 

analysis as long as the tissue 

does not contain more than 100 

microCuries (3.7 megabecquerels) 

of Tc-99m, which is based on the 

exemption criteria in 10 CFR 30.18.

(Contact: Cindy Flannery, Office of 

Federal and State Materials 

and Environmental Management 

Programs, 301-415-0223; e-mail: 

Cindy.Flannery@nrc.gov)

LAST PHASE OF WAIVER 

TERMINATIONS OF NRC 

REGULATORY AUTHORITY 

FOR CERTAIN NATURALLY 

OCCURRING AND 

ACCELERATOR-PRODUCED 

RADIOACTIVE MATERIAL 

(NARM)

The Energy Policy Act (EPAct) of 

2005 gave the NRC regulatory 

authority over NARM. NRC’s final 

rule implementing this authority 

was effective November 30, 2007 

(72 FR 55863).

A waiver was issued on August 

31, 2005, to allow continued use 

and possession of NARM while 

the NRC developed its regulatory 

framework. The NRC has been 

terminating waivers in phases. 
3

On March 31, 2009, Virginia 

became the 36th Agreement 

State. Last year, it was 

Pennsylvania. New Jersey has 

filed an application to become 

an Agreement State and NRC 

staff has it under review. A few 

other States have expressed 

interest and are laying the 

groundwork now. 

As Director of the Office of Federal and State Materials and Environmental Management Programs (FSME), it 

is my daily responsibility to acknowledge and make appropriate use of the talents and regulatory expertise of 

State regulators along with the skills of my own staff and our regional counterparts. I have occasionally been 

kidded about the length of the office title, but the Federal/State regulatory partnership is unique and it is 

important for me as the FSME Director to never forget that and leverage all the talents across the nation. 

I was particularly encouraged by the attendance of the leadership of the Organization of Agreement States, 

Inc. (OAS) and the Conference of Radiation Control Program Directors, Inc. (CRCPD) in the March 16, 2009, 

Commission briefing, in which I outlined some of the program’s recent accomplishments, priorities and areas 

in which we look for Commission guidance. From December 2008 through December 2009, the Commission 

calendar had, and will have, a number of meetings involving FSME activities (uranium recovery, low-level waste, 

source security, the annual Advisory Committee of Medical Use of Isotopes, just to name a few). In many cases, 

OAS and CRCPD have participated or will be participating. I appreciate the time and energy this requires, but I 

believe it is highly worthwhile means of providing important context and additional perspectives which allow 

the Commission to make more informed decisions.

I would also like to acknowledge and credit the States for their continued participation in numerous Working 

Groups and Steering Committees which provide updated guidance and rulemakings across the FSME program 

domain. The States continue to enrich the regulatory infrastructure, and now directly regulate about 85% of 

the nation’s byproduct materials licensees. I look forward to continuing to work with the States, and with over 

20,000 of the nation’s licensees to ensure the safe and secure use of radioactive materials.

Charles L. Miller, Director

fromthedesk 

ofthefsme

director
4

radiopharmaceuticals, medical use 

of byproduct material).

NARM users in Phase 2 States 

should have submitted their 

license amendments by 

March 30, 2009, and must submit 

new license applications by 

September 30, 2009.

More information on NARM 

related activities can be found 

on the “NARM Toolbox” at the 

NRC’s Office of Federal and State 

Materials and Environmental 

Management Programs (FSME) 

Web site at http://nrc-stp.ornl.gov/

narmtoolbox.html. One of the 

more recent documents posted 

on the NARM Toolbox is a recently 

issued Regulatory Issue Summary 

2008-13, “Status and Plans for 

Implementation of NRC Authority 

for Certain Naturally Occurring 

and Accelerator-Produced 

Radioactive Material,” issued on 

June 16, 2008 (http://nrc-stp.ornl.

gov/narmtoolbox/ris2008-13.pdf).

(Contacts: Shirley Xu, Office of 

Federal and State Materials and 

Environmental Management 

Programs, 301-415-7640; e-mail: 

Shirley.Xu@nrc.gov)

NRC COMPLETES THE 

COMMONWEALTH OF 

VIRGINIA AGREEMENT

On February 27, 2009, the U.S. 

Nuclear Regulatory Commission 

(NRC) approved an Agreement 

with the Commonwealth 

of Virginia (Virginia or 

Commonwealth) under Section 

274b. of the Atomic Energy Act 

of 1954, as amended (AEA). 

Under the agreement, the 

NRC will transfer to Virginia 

the responsibility for licensing, 

rulemaking, inspection 

and enforcement 

activities for: 

(1)radioactive materials 

produced as a result 

of processes related 

to the production or 

utilization of special 

nuclear material 

(SNM); 

(2)naturally occurring or 

accelerator-produced 

radioactive material 

(NARM);

(3)source material 

(uranium and thorium); and 

(4)SNM in quantities not sufficient 

to form a critical mass.

Virginia becomes the 36th State 

to sign such an agreement with 

the NRC. The agreement became 

effective March 31, 2009. 

The NRC transferred approximately 386 licenses to the 

Commonwealth’s jurisdiction. In 

addition, the Commonwealth 

retains regulatory authority for 

approximately 216 NARM licenses. 

Approximately 180 of these NARM 

licenses currently are regulated by 

both Virginia and the NRC.

By law, NRC retains jurisdiction 

over commercial nuclear power 

plants and federal agencies 

using certain nuclear material 

in Virginia. In addition, NRC 

retains authority for the review, 

evaluation and approval of 

sealed radioactive materials and 

devices containing certain nuclear 

materials manufactured in Virginia 

and distributed throughout the 

country. 

Before approving the agreement, 

NRC reviewed Virginia’s radiation 

control program to ensure it is 

adequate to protect public health 

and safety and is compatible 

with the agency’s own program 

for regulating the radioactive 

materials covered in the 

agreement. An announcement 

of the proposed agreement 

was published four times in the 

Federal Register in November 

and December 2008, inviting 

comments from the public. The 

agency received one comment in 

favor of the proposed agreement. 

The governor’s request and 

supporting documents, as well 

as the NRC staff’s assessment 

are available through the NRC’s 

Agency-wide Documents Access 

and Management System 

(ADAMS). Help in using ADAMS is 

available by contacting the NRC 

Public Document Room staff at 

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

or by sending an e-mail message 

to PDR.Resource@nrc.gov. These 

documents are also available 

for public inspection at the NRC 

Public Document Room at 11555 

Rockville Pike, Rockville, Maryland. 

Thirty-five other States have 

previously signed such agreements 

with NRC. They are: Alabama, 

Arizona, Arkansas, California, 

Colorado, Florida, Georgia, Illinois, 

Iowa, Kansas, Kentucky, Louisiana, 

Maine, Maryland, Massachusetts, 

continued from page 2

Mike Welling presents FSME Management and staff with 

274b Agreements signed by Governor Timothy M. Kaine 

on March 18, 2009
5

Minnesota, Mississippi, Nebraska, 

Nevada, New Hampshire, New 

Mexico, New York, North Carolina, 

North Dakota, Ohio, Oklahoma, 

Oregon, Pennsylvania, Rhode 

Island, South Carolina, Tennessee, 

Texas, Utah, Washington, and 

Wisconsin.

(Contact: Monica Orendi, Office 

of Federal and State Materials 

and Environmental Management 

Programs, 301-415-3938, email: 

monica.orendi@nrc.gov.) 

NRC ISSUES 

CONFIRMATORY ORDER 

TO MATTINGLY TESTING 

SERVICES

The U.S. Nuclear Regulatory 

Commission has issued a 

Confirmatory Order to Mattingly 

Testing Services, Inc. of Molt, 

Montana, to take corrective actions 

designed to improve compliance 

with NRC regulations for the 

possession and use of radioactive 

materials.

Mattingly has agreed to the terms 

and conditions of the Confirmatory 

Order that requires it to take a 

number of actions including: 

(1)hiring an independent 

consultant to evaluate the 

effectiveness of its radiation 

safety and compliance 

programs, 

(2)hiring an independent 

consultant to provide training,

(3)improving procedures, 

(4)improving Mattingly’s 

disciplinary program, and 

(5) paying a civil penalty in the 

amount of $8,000. 

In addition, the company’s 

president/radiation safety officer 

has agreed not to participate in 

any NRC-licensed activities for two 

years. 

Mattingly has already 

implemented many corrective 

actions designed to prevent 

recurrence. The terms of the 

Confirmatory Order were agreed 

to following Alternative Dispute 

Resolution, which uses a neutral 

mediator with no decision-making 

authority to assist the NRC and its 

licensees in resolving differences 

regarding enforcement actions.

The actions stemmed from an 

NRC inspection and investigation 

initiated in 2007 that identified 

nine apparent violations of NRC 

regulations, including failure 

by company officials to provide 

complete and accurate information 

to the NRC staff; failure by a worker 

to wear a personal dosimeter 

while performing radiographic 

operations; and failure to remove 

from service a device containing 

radioactive materials after its 

locking mechanism sustained 

damage.

Copies of the Confirmatory Order 

issued by the NRC to Mattingly are 

available on the NRC web site at: 

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

adams.html.

(Contact: Victor Dricks, Region IV, 

817-860-8128, e-mail: 

Victor.Dricks@nrc.gov)

LICENSEE BANKRUPTCY 

AND/OR CHANGE OF 

CONTROL

Financial difficulties have 

unfortunately become a reality 

for many American businesses, 

including those engaged in NRC 

licensed activities. Commonly, 

financial relief is sought through 

bankruptcy proceedings or the 

selling of assets, including the 

transfer of licensed material 

or change of control of NRC 

licensed activities. Often, NRC 

first becomes aware of a licensee’s 

financial difficulties when a 

licensee has not paid their fees 

to NRC. In other cases, NRC 

inspectors become aware of 

the situation when attempting 

to perform an inspection but 

instead find an abandoned or 

permanently shut down licensee 

facility. Occasionally during an 

NRC inspection, it is revealed 

that the entity has undergone 

a change of control of licensed 

activities without prior NRC 

approval. Licensees might not be 

familiar with NRC regulations that 

require licensees to take specific 

actions with respect to bankruptcy 

proceedings as well as change of 

control of NRC licensed activities. 

These regulations have been 

promulgated, in part, to ensure 

adequate protection of public 

health and safety and the security 

of radioactive material. The 

discussion that follows presents 

a brief overview of byproduct 

material licensee responsibilities 

regarding bankruptcy or change of 

control of NRC licensed activities. 

The purpose of the bankruptcy 

notification requirement is to allow 

NRC to verify the safe disposition 

of radioactive material possessed 

by the bankrupt licensee. Often, 

when seizing assets, trustees 

or creditors unknowingly take 

possession of radioactive material. 

Licensed material handled without 

proper radiation safety precautions 

can create a significant public 

health and safety hazard. NRC 

regulations require that licensees 

inform NRC of bankruptcy 

proceedings. Specifically, 
6

10 CFR 30.34(h) requires, in 

part, that licensees notify the 

appropriate NRC Regional 

Administrator, in writing, 

immediately following the filing 

of a voluntary or involuntary 

petition for bankruptcy under 

any chapter of Title 11 of the 

United States Code. This applies 

to petitions for bankruptcy filed 

by or against: (1) the licensee, (2) 

an entity controlling the licensee 

or listing the licensee/license as 

property of an estate, or (3) an 

affiliate of the licensee. Following 

NRC notification of bankruptcy 

proceedings, an onsite NRC 

inspection is sometimes necessary 

to verify safety and security and/

or proper disposal or transfer of 

licensed materials.

Control of licensed activities can 

be described as the authority to 

make decisions regarding the 

possession, storage, or use of 

licensed materials. NRC does 

not seek to become involved 

in business decisions made by 

licensees. However, NRC needs 

to be informed when authority 

of NRC licensed activities has 

changed. Furthermore, control 

of licensed activities cannot 

be transferred without written 

consent from NRC. Specifically, 

10 CFR 30.34(b) requires, in part, 

that no license issued or granted 

pursuant to the regulations in 10 

CFR Part 30 and parts 31 through 

36, and 39 nor any right under 

a license shall be transferred, 

assigned or in any manner 

disposed of, either voluntarily or 

involuntarily, directly or indirectly, 

through transfer of control of 

any license to any person, unless 

the NRC shall, after securing 

full information, find that the 

transfer is in accordance with 

the provisions of the Atomic 

Energy Act of 1954 (including any 

amendments thereto) and shall 

give its consent in writing. Timely 

notification is expected so that 

NRC can perform an appropriate 

review of the change of control. 

Through this review, NRC can 

determine whether radiation 

safety and security over licensed 

materials will be maintained 

during and after the change of 

control. In addition to NRC’s 

review of licensee-submitted 

information, an onsite visit of 

licensee facilities may be required 

prior to NRC approval of change of 

control of licensed activities. 

When not appropriately managed, 

bankruptcies and change of 

control of licensed activities can 

lead to a potential loss of control 

of radioactive material and 

resultant threat to public health 

and safety. Regardless of financial 

or organizational issues, licensees 

remain responsible for the safety, 

security and control of licensed 

materials. Failure to notify NRC 

and/or maintain control of licensed 

material could lead to enforcement 

actions. Early notice made to NRC 

regarding bankruptcy or change 

of control will enable NRC staff 

to provide additional guidance 

regarding the type of information 

required to complete the review 

in a timely manner. Under certain 

circumstances, NRC may be able 

to assist licensees regarding 

appropriate transfer or available 

means for disposal of licensed 

material. 

Further information and guidance 

regarding these subjects can 

be found in NUREG-1556, Vol. 

15, Guidance About Changes of 

Control and About Bankruptcy 

Involving Byproduct, Source, or 

Special Nuclear Materials Licenses. 

This document can be located on 

NRC’s public web page at: http://

www.nrc.gov/reading-rm/doccollections/nuregs/staff/sr1556/

v15/. Additionally, licensees 

who have questions regarding 

this subject are encouraged to 

contact the licensing staff of their 

appropriate NRC Regional office.

(Contact: Janine F. Katanic, PhD, 

CHP, Office of Federal and State 

Materials and Environmental 

Management Programs, 

817-860-8151; e-mail: 

Janine.Katanic@nrc.gov) 

NRC IS SEEKING 

PUBLIC COMMENT ON 

REGULATORY ISSUES 

AND OPTIONS FOR 

POTENTIAL CHANGES 

TO THE AGENCY’S 

RADIATION PROTECTION 

REGULATIONS

In December 2007, the 

International Commission on 

Radiological Protection (ICRP) 

revised and updated their 

recommendations for radiation 

protection as ICRP Publication 103. 

Electronic or paper copies of the 

recommendations are available 

for purchase from the ICRP, www.

icrp.org. Shortly thereafter, 

the U.S. Nuclear Regulatory 

Commission (NRC) staff engaged 

in a comparative review of the NRC 

Standards for Protection Against 

Ionizing Radiation, 10 CFR Part 

20, and other NRC regulations, 

with ICRP Publication 103, and 

provided the Commission with 

recommendations for next steps 

towards alignment. In a Staff 

Requirements Memorandum 

(SRM) dated April 2, 2009, the 

Commission approved the staff’s 
7

recommendation to immediately 

begin engagement with 

stakeholders and interested parties 

to initiate development of the 

technical basis for possible revision 

of the NRC’s radiation protection 

regulations, as appropriate and 

where scientifically justified. 

The Commission believes that 

the current NRC regulatory 

framework continues to provide 

adequate protection of health 

and safety of workers, the public, 

and the environment. From a 

safety regulation perspective, 

ICRP Publication 103 proposes 

measures that go beyond what 

is needed to provide adequate 

protection. In order to ensure 

that the NRC is well informed 

of all the benefits and burdens 

associated with further alignment 

of NRC’s current radiation 

protection regulations with ICRP 

103, NRC staff will actively engage 

stakeholders and interested parties 

on the technical and regulatory 

issues associated with such 

changes. The NRC will use public 

comments gathered over the next 

two to three years to develop an 

appropriate technical basis and 

make suggestions for proposed 

rulemaking to the Commission. 

The NRC staff is particularly 

interested in understanding 

the perspectives of different 

organizations and groups on the 

benefits, burdens, and impacts 

of possible options for change. 

The NRC staff has not made any 

decisions on particular positions or 

changes at this time. An initial set 

of key topics for discussion include 

the occupational dose limits, the 

application of constraints to the 

optimization process, and updates 

of the scientific information 

and models supporting dose 

assessment and compliance. 

The NRC wishes to interact with 

many stakeholder and interested 

parties including the public, 

licensees, labor unions, public 

interest groups, state regulatory 

agencies, scientific professional 

societies and organizations, the 

Interagency Steering Committee 

on Radiation Standards, other 

federal agencies, and other 

organizations while developing 

the technical basis. Plans have 

already been made to make 

presentations at the meetings 

of the Conference of Radiation 

Control Program Directors, Inc., 

the Society of Nuclear Medicine, 

the Health Physics Society, and 

the American Association of 

Physicists in Medicine. The NRC 

is also developing a dedicated 

Web site for information and 

public comments on this issue. 

Comments may also be submitted 

by e-mail to Regs4RP@nrc.gov. 

(Contacts: Dr. Donald Cool, Office 

of Federal and State Materials 

and Environmental Management 

Programs, 301-415-6347; e-mail: 

Donald.Cool@nrc.gov; or Dr. 

Kimyata Morgan Butler, Office of 

Federal and State Materials and 

Environmental Management 

Programs, 301-415-0733; e-mail: 

Kimyata.MorganButler@nrc.gov)

SIGNIFICANT 

ENFORCEMENT ACTIONS

The U.S. Nuclear Regulatory 

Commission’s (NRC’s) enforcement 

program can be accessed via 

NRC’s homepage [http://www. 

nrc.gov/about-nrc/regulatory/

enforcement/current.html] under 

“Recently Issued Significant 

Enforcement Action.” Documents 

related to cases can be accessed at 

[http://www.nrc.gov/], “Electronic 

Reading Room,” “Documents in 

ADAMS.” ADAMS is the Agencywide 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.

Medical

St. John Macomb-Oakland 

Hospital (EA-08-329) 

On February 18, 2009, a Notice 

of Violation (NOV) was issued 

for a Severity Level III violation. 

The NOV involved a violation of 

Condition 11.B of the facility’s 

license, which authorized a 

specifically named individual to 

fulfill the responsibilities of the 

Radiation Safety Officer (RSO) 

for the brachytherapy activities. 

Specifically, as of November 

2007, the authorized individual 

was no longer employed by the 

consulting firm retained by the 

licensee and did not fulfill the RSO 

responsibilities. The licensee failed 

to appoint a new RSO following 

the previous RSO’s departure from 

the consulting firm. 

Radiography

Huntington Testing & 

Technology, Inc. (EA-08-303) 

On January 22, 2009, a Notice of 

Violation (NOV) was issued for 

a Severity Level III problem. The 

violations involved the failure to 

comply with license condition 

and to provide event notification 

as required, in a timely manner. 

Specifically, on August 20, 2008, 

the licensee had an event where a 

radiography camera was disabled 

and failed to function as designed. 

The lead radiographer and the 

field Radiation Safety Officer, who 

were not trained or authorized by 

the NRC license, conducted source 
8

retrieval activities and shieldeddown a source. In addition, the 

licensee did not notify the NRC 

until September 3, 2008, two 

weeks after this event. 

Individual Actions

Robert S. Beveridge (IA-08-054)

On February 24, 2009, a Notice 

of Violation was issued for 

a Severity Level III violation 

involving a deliberate submission 

of information to the licensee 

knowing that the information was 

incomplete or inaccurate in some 

respect material to the NRC and 

deliberately caused the licensee to 

be in violation of NRC regulations. 

Specifically, Mr. Beveridge, the 

former Radiation Safety Officer 

(RSO), deliberately entered data 

into inventory records indicating 

that the inventory had been 

completed, when in actuality the 

inventory had not been completed 

as required. 

(Contact: Michele Burgess, Office 

of Federal and State Materials 

and Environmental Management 

Programs, 301-415-5868; e-mail: 

Michele.Burgess@nrc.gov)

GENERIC 

COMMUNICATIONS 

ISSUED

(January 1, 2009 - March 31, 2009)

The following are summaries 

of U.S. Nuclear Regulatory 

Commission (NRC) generic 

communications issued by 

the Office of Federal and State 

Materials and Environmental 

Management Programs. If one of 

these documents appears relevant 

to your needs and you have not 

received it, please call one of the 

technical contacts listed below. 

The Internet address for the NRC 

library of generic communications 

is http://www.nrc.gov/reading-rm/

doc-collections/gen-comm/index.

html. Please note that this address 

is case-sensitive and must be 

entered exactly as shown. 

Bulletins (BLs)

None.

Generic Letters (Gls)

None.

Information Notices (INs)

IN 2009-01, “National Response 

Framework” was issued January 

22, 2009. This IN was issued to 

all holders of operating licenses 

or certificates for nuclear power 

plants, research and test reactors, 

independent spent fuel storage 

installations, and fuel cycle 

facilities; all holders of operating 

licenses for uranium recovery 

facilities; all holders of licenses 

or certificates for the following 

types of facilities undergoing 

decommissioning: nuclear power 

plants, research and test reactors, 

fuel cycle facilities, and uranium 

recovery facilities. 

(Technical contact: Michael 

I. Dudek, Office Of Nuclear 

Security And Incident Response, 

301-415-6500, email: Michael.

Dudek@nrc.gov.)

Regulatory Issue Summaries (RIS)

None.

General Contact: Angela R. 

McIntosh, FSME, 301-415-5030; 

Angela.McIntosh@nrc.gov 

SIGNIFICANT EVENTS

Event #1 Wrong Treatment Site 

Error Involving High Dose Rate 

Remote Afterloader

Date and Place: February 23, 2009, 

Pittsburg, Pennsylvania

Nature and Probable Causes: The 

licensee reported that a female 

patient received a high dose rate 

mammosite treatment to the 

wrong site between February 23 

and February 27, 2009. The patient 

was to receive treatment twice 

a day for a total of 10 fractions 

with an expected dose of 3,400 

cGy (rad) to the intended site. A 

dummy wire was inserted into the 

balloon to check and measure the 

tube length for dose calculations. 

A CAT scan was performed daily to 

verify the position of the treatment 

site. Treatment calculations 

were performed, reviewed, and 

approved, and treatment began 

on February 23. On February 27, 

a different therapy physicist was 

checking the patient’s charts and 

believed there may have been 

an error. On March 2, 2009, the 

original physicist checked the 

findings and discovered that 

there had been an error in the 

placement of the source during 

treatments. The source had 

not been fully inserted into the 

balloon, and was 3 cm from where 

it should have been. That incorrect 

source placement resulted in the 

tumor site only receiving 30% of 

the intended dose. An unintended 

site received the total treatment. 

The patient is being followed 

for any sequelae (pathological 

conditions) to the event. The 

oncologist discussed the event 

with the patient.
9

Event #2: Seed Displacement 

Results in Wrong Treatment 

Site Error

Date and Place: March 19, 2009, 

Voorhees, New Jersey

Nature and Probable Causes: The 

licensee reported that I-125 seeds 

were implanted outside the target 

organ during a prostate seed 

brachytherapy implant procedure 

performed on March 19, 2009. 

The incident was discovered 

while the physicist conducted 

a post operative dosimetry 

analysis of the procedure. It was 

determined that none of the seeds 

were implanted in the prostate 

gland. The seeds retained their 

planned pattern grouping, with 

the superior end of the seed 

cloud being approximately 2 cm 

from the apex of the prostate 

gland. A dosimetric analysis of 

the CT image revealed all 93 seeds 

accounted for and a calculated 

dose to 90% of the target organ 

(prescription line) being 224 cGy 

(rad). The prescribed dose in the 

written directive was 14,500 cGy 

(rad). The seeds appeared distal 

to the prostate and the dose 

appeared to have been maximally 

confined to soft tissue, including 

muscle and subcutaneous fat. A 

complete analysis was requested 

of the radiation oncologist, who 

was immediately informed. The 

license administrator and nuclear 

medicine manager were notified.

Event #3: Incorrect Isotope 

and Activity Ordered Resulting 

in Medical Event

Date and Place: December 29, 2008, 

(City Not Reported) New York

A medical facility reported that 

a patient was prescribed 11.1 

MBq (300 uCi) of I-123, but was 

administered 72.5 MBq (1.96 mCi) 

of I-131 on December 29, 2008. 

A referring physician requested 

an uptake study and scan to be 

followed by an I-131 therapy for 

thyrotoxicosis. The authorized 

user (AU) directed the secretary to 

schedule the uptake study using 

I-123. However, the secretary 

scheduled the patient for a whole 

body scan using I-131. On the day 

of the study, the nuclear medicine 

technologist took the patient’s 

history, which included the fact 

that she still had her thyroid. 

The technologist failed to seek 

clarification from the AU and did 

not review the AU’s approval. The 

technologist proceeded with the 

whole body study using the I-131. 

Upon discovery of the error, the AU 

had an uptake study performed. 

The AU notified the patient and 

referring physician. Results of the 

uptake study revealed that the 

patient was thyrotoxic. The AU 

prescribed a therapy dose of 370 

MBq (10 mCi) of I-131. An error in 

scheduling precipitated this event. 

The failure of the technologist to 

seek clarification and review the 

physician’s order caused the event. 

Corrective actions included a 

requirement for verification of the 

prescription by two technologists 

and the need to consult with 

the AU if there are any questions 

regarding the ordered procedure.

(Contact: Angela R. McIntosh, 

Office of Federal and State 

Materials and Environmental

Management Programs, 

301-415-5030; e-mail: 

Angela.McIntosh@nrc.gov)

SELECTED FEDERAL 

REGISTER NOTICES

Final Memorandum of 

Understanding Between the U.S. 

Nuclear Regulatory Commission 

and the Virginia Department of 

Health (NRC-2009-0008), 74 FR 

3105, January 16, 2009.

(Contact: Robert Stransky, Office 

of Nuclear Security and Incident 

Response, 301-415–6411, e-mail: 

Robert.Stransky@nrc.gov)

Notification of Impending 

Waiver Termination (RIN AH84) 

(NRC-2006-0011), 74 FR 5797, 

February 2, 2009.

(Contact: Shirley Xu, Office of 

Federal and State Materials and 

Environmental Management 

Programs, 301-415–7640, e-mail: 

Shirley.xu@nrc.gov.)

List of Approved Spent Fuel 

Storage Casks: MAGNASTOR 

Addition, Confirmation of Effective 

Date (RIN AI51) (NRC-2008-0568), 

74 FR 5983, February 4, 2009.

(Contact: Jayne M. McCausland, 

Office of Federal and State 

Materials and Environmental 

Management Programs, 

301-415–6219, e-mail: 

Jayne.McCausland@nrc.gov.)

Protection of Safeguards 

Information; Correction (AH57) 

(NRC-2005-0001), 74 FR 6989, 

February 12, 2009.

(Contact: Michael T. Lesar, Chief, 

Office of Administration, 

301-492–3663, e-mail: 

Michael.Lesar@nrc.gov.)

Regulatory Changes To Implement 

the Additional Protocol to the 

US/IAEA Safeguards Agreement; 

Correction, (RIN AH38) 

(NRC-2008-0543), 74 FR 7549, 

February 18, 2009.
10

NOTE TO READERS: In an attempt to keep the FSME 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 FSME Licensee 

Newsletter readership, should contact Gwendolyn Davis, from the FSME Division of Intergovernmental Liaison and 

Rulemaking, Rulemaking Branch A. Ms. Davis may be contacted at 301- 415-8165 or Gwendolyn.Davis@nrc.gov. 

In addition, to ensure proper delivery of the FSME Licensee Newsletter, please report any address changes to 

Ms. Davis to prevent any interruption of service.

Please send written correspondence and requests to: 

Gwendolyn Davis

FSME 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

(Contact: Michael T. Lesar, Chief, 

Office of Administration, 

301-492–3663, e-mail: 

Michael.Lesar@nrc.gov.)

Revision of Fee Schedules; 

Fee Recovery for FY 2009 (RIN 

3150–AI52) (NRC–2008–0620), 

74 FR 9130 March 2, 2009.

(Contact: Rebecca I. Erickson, 

Office of the Chief Financial Officer, 

301-415–7126, e-mail: 

Rebecca.Erickson@NRC.gov.)

Implementation of a Dose 

Standard After 10,000 Years (RIN 

AH68) (NRC-2005-0011), 74 FR 

10811, March 13, 2009.

(Contact: Timothy McCartin, 

Office of Nuclear Material Safety 

and Safeguards, 301-492–3167, 

e-mail: Timothy.McCartin@

nrc.gov; or Janet Kotra, Office 

of Nuclear Material Safety and 

Safeguards, 301-492–3190, e-mail: 

Janet.Kotra@nrc.gov; or Robert 

MacDougall, Office of Federal a

nd State Materials and 

Environmental Management

Programs, 301- 415–5175, e-mail: 

Robert.MacDougall@nrc.gov.)